id|nct_id|outcome_type|title|description|time_frame|population|anticipated_posting_date|anticipated_posting_month_year|units|units_analyzed|dispersion_type|param_type
2524511|NCT04336475|Primary|Change From Baseline in Oral Aperture Measurement|the interincisal distance between the maxillary and mandibular central incisors in the midline|2 months||||milimeters||Standard Deviation|Mean
2524512|NCT04322526|Primary|Naltrexone-induced Changes in BOLD Responses in the rACC Cortex During the Processing of Contextual Cues (Placebo vs. Naltrexone)|In order to identify naltrexone-induced changes in the neural correlates of contextual processing, we examined changes in blood oxygenation level-dependent (BOLD) during the fMRI scanning session between Naltrexone vs. placebo pill.|[Approximately at day 1, 7]|The goal of aim two was to investigate the effects of one single dose of naltrexone on the neural correlates of antidepressant placebo effects. This aim was accomplished by examining changes in the neural responses to the Antidepressant placebo fMRI task from the naltrexone to the placebo session, regardless of the order of each intervention.|||changes in BOLD signal||Standard Deviation|Mean
2524513|NCT04322526|Primary|BOLD Responses in the rACC Cortex During the Processing of Contextual Cues at Baseline (Post-placebo)|In order to identify the neural correlates of contextual processing, we examined changes in blood oxygenation level-dependent (BOLD) signal during the post-placebo fMRI scanning session.|[Approximately at day 1, 7]|The goal of aim one was to identify the neural correlates of antidepressant placebo effects. This aim was accomplished by examining the neural responses to the Antidepressant placebo fMRI task during the placebo session only, regardless of whether participants were assigned to the placebo-naltrexone or the naltrexone-placebo intervention.|||BOLD signal||Standard Deviation|Mean
2524514|NCT04322500|Primary|Number of Recurrences|complete ophthalmological evaluation was done weekly during the first month and then monthly in order to evaluate possible recurrences (presence of a new eyelid mass lesion)|3 months||||recurreces|||Number
2524515|NCT04322500|Primary|Time Taken for a Complete Resolution of the Chalaziosis|change in the time taken for complete resolution of chalaziosis (complete disappearance of the eyelid mass lesions)|3 months|"Change in the time taken for complete resolution of chalaziosis :~Group A: 51.2±12.4 days~Group B: 28.4±10.8 days"|||days||Standard Deviation|Mean
2524516|NCT04287517|Secondary|Short Form - 36 (SF-36) Score Change|The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and an abbreviated variant of it. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|baseline, pre-intervention and 24 hours after the last intervention||||score on a scale||Standard Deviation|Mean
2524517|NCT04287517|Secondary|Cervical Range of Motion (cROM) Change|The cervical spine's range of motion is approximately 80° to 90° of flexion, 70° of extension, 20° to 45° of lateral flexion, and up to 90° of rotation to both sides.|baseline, pre-intervention and 24 hours after the last intervention||||Degree||Standard Deviation|Mean
2524518|NCT04287517|Secondary|Neck Disability Index (NDI) Score Change|The Neck Disability Index (NDI) is a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. Each question has six statement, the first statement is marked the section score = 0, if the last statement is marked it = 5. Maximum score is 50 and minimum is 0. Lower scores mean better outcome.|baseline, pre-intervention and 24 hours after the last intervention||||score on a scale||Standard Deviation|Mean
2524519|NCT04287517|Primary|Pain Pressure Threshold (PPT) Score Change|PPT is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom. Higher scores mean better outcome.|baseline, pre-intervention and 24 hours after the last intervention||||N/m^2||Standard Deviation|Mean
2524520|NCT04287517|Primary|Visual Analog Scale (VAS) Score Change|The VAS is a tool used to help a person rate the intensity of certain sensations and feelings. This Outcome Measure will assess pain. This VAS is a straight horizontal line of fixed length from 0 to 10 cm with 0 cm indicating no pain and 10 cm indicating the worst pain imaginable.|baseline, pre-intervention and 24 hours after the last intervention||||score on a scale||Standard Deviation|Mean
2524521|NCT04272775|Secondary|Number of Participants Who Achieved Complete Response (CR), Very Good Partial Response (VGPR), and Partial Response (PR)|Number of participants who achieved CR, PR, VGPR were assessed in accordance to International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma. CR: No immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow. Normal serum free light chain (SFLC) ratio if disease measurable only by SFLC. VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or greater than or equal to (>=) 90% decrease in serum M-protein with urine M-protein <100 milligram per 24 hours (mg/24 hrs). If disease measurable only by SFLC, >= 90% decrease in the difference between involved and uninvolved FLC levels (dFLC). PR: >= 50% reduction of serum M-protein and >= 90% reduction in urine M-protein or to <200 mg/24 hrs, or a >= 50% decrease in dFLC. A >=50% decrease in the size of soft tissue plasmacytomas present at baseline|Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days)|The response evaluable analysis set consisted of all participants who received at least one dose of ixazomib, have measurable disease at baseline, and at least one postbaseline response assessment.|||Participants|||Count of Participants
2524522|NCT04272775|Primary|Cmax: Maximum Observed Plasma Concentration for Ixazomib||Days 1 and 15 of Cycle 1: pre-dose and at multiple time points (15, 30, 60, and 90 minutes and 2, 4, 8, 24, 48, 96, and 168 hours) post-dose (Cycle length=28 days)|The pharmacokinetic (PK) analysis set consisted of all participants who received at least one dose of ixazomib and has evaluable PK data. The PK analysis set where data at specified time points was available.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2524523|NCT04272775|Primary|Number of Participants With Grade 3 or Higher Laboratory Tests Abnormalities|Laboratory tests abnormalities were graded using the CTCAE version 4.03. as: Grade 1 (Mild, asymptomatic or mild symptoms); Grade 2 (Moderate, minimal, local or noninvasive intervention indicated); Grade 3 (Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (Life-threatening consequences, urgent intervention indicated); Grade 5 (Death related to AE).|Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days)|The safety analysis set consisted of all participants who received at least one dose of ixazomib.|||Participants|||Count of Participants
2524524|NCT04272775|Primary|Number of Participants With Grade 3 or Higher TEAE Related to 12-lead Electrocardiograms (ECGs)|12-lead ECGs were graded using the CTCAE version 4.03. as: Grade 1 (Mild, asymptomatic or mild symptoms); Grade 2 (Moderate, minimal, local or noninvasive intervention indicated); Grade 3 (Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (Life-threatening consequences, urgent intervention indicated); Grade 5 (Death related to AE).|Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days)|The safety analysis set consisted of all participants who received at least one dose of ixazomib.|||Participants|||Count of Participants
2524525|NCT04272775|Primary|Number of Participants With Grade 3 or Higher TEAE Related to Vital Signs|Vital signs were graded using the CTCAE version 4.03. as: Grade 1 (Mild, asymptomatic or mild symptoms); Grade 2 (Moderate, minimal, local or noninvasive intervention indicated); Grade 3 (Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (Life-threatening consequences, urgent intervention indicated); Grade 5 (Death related to AE).|Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days)|The safety analysis set consisted of all participants who received at least one dose of ixazomib.|||Participants|||Count of Participants
2524526|NCT04272775|Primary|Number of Participants With Grade 3 or Higher TEAE Related to Body Weight|Body weight abnormalities were graded using the CTCAE version 4.03. as: Grade 1 (Mild, asymptomatic or mild symptoms); Grade 2 (Moderate, minimal, local or noninvasive intervention indicated); Grade 3 (Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated); Grade 4 (Life-threatening consequences, urgent intervention indicated); Grade 5 (Death related to AE).|Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days)|The safety analysis set consisted of all participants who received at least one dose of ixazomib.|||Participants|||Count of Participants
2524527|NCT04272775|Primary|Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)||Baseline up to 29 days after last dose of study drug (up to Cycle 87 Day 44) (Each Cycle length=28 days)|The safety analysis set consisted of all participants who received at least one dose of ixazomib.|||Participants|||Count of Participants
2524528|NCT04272775|Primary|Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)|DLT:Any following adverse events (AEs) possibly related to ixazomib assessed by Common Terminology Criteria for AEs (CTCAE) version 4.03; Grade 4 neutropenia/thrombocytopenia lasting >7 consecutive days; Grade 3/greater neutropenia with fever/infections; Grade 3/greater thrombocytopenia with clinically significant bleeding; platelet count less than (<)10,000 per cubic meter(/mm^3); Grade 2 peripheral neuropathy with pain/Grade 3 or greater peripheral neuropathy; Grade 3/greater nonhematologic toxicities with exceptions of arthralgia/myalgia, fatigue lasting <7 days manageable nausea/emesis with antiemetic prophylaxis, diarrhea that is controlled with supportive care; treatment delay of >14 days at start of Cycle 2 due to failure of hematologic/nonhematologic recovery; Other Grade 2/greater ixazomib related nonhematologic toxicities required permanent discontinuation of ixazomib;Inability to receive at least 80% of planned lenalidomide doses due to the AEs related to ixazomib.|From Cycle 1 Day 1 until Cycle 2 Day 1 (Cycle length is equal to [=] 28 days)|The DLT analysis set consisted of DLT evaluable participants who received at least one dose of ixazomib.|||Participants|||Count of Participants
2524529|NCT04267770|Primary|Change in Basal Insulin Rate|Absolute change in insulin basal rate over 24 hours after 3 rounds of basal rate testing (calculated by the sum of absolute changes for each 1 hour block compared with baseline)|over 24 hours after 3 rounds of basal rate testing||||Units of insulin||Inter-Quartile Range|Median
2524530|NCT04241146|Secondary|Number of X-Rays|Number of X-rays required to achieve correct tube placement|Baseline to End of procedure up to 30 minutes||||x-rays||Full Range|Mean
2524531|NCT04241146|Primary|Duration of Time|Time taken for placement of enteral tube|Baseline to End of procedure up to 30 minutes||||Minutes||Inter-Quartile Range|Median
2524532|NCT04222699|Primary|Change in the Abundance of Gram Negative Bacteria on the Femoral Skin After Decolonization|Quantitative PCR using 16S rRNA is used to quantify the total bacterial load of Gram negative bacteria on the femoral skin before and after decolonization.|12 months|Femoral skin samples deteriorated prior to sample analysis and cannot be used.||||||
2524533|NCT04222699|Primary|Change in the Abundance of Gram Negative Bacteria on the Subclavian Skin After Decolonization|Quantitative PCR using 16S rRNA is used to quantify the total bacterial load of Gram negative bacteria on the subclavian skin before and after decolonization.|12 months|Subclavian skin samples deteriorated prior to sample analysis and cannot be used.||||||
2524534|NCT04222699|Primary|Change in the Abundance of Staphylococcus Aureus in the Throat After Decolonization|Change in the abundance of Staphylococcus aureus in the throat from immediately before mupirocin administration to 8 weeks after mupirocin administration.|8 weeks|Out of the 28 participants assigned to this group, 2 were lost to follow-up and 1 had an insufficient amount of sample collected and could not be included in the analysis.|||fg/uL||Standard Deviation|Mean
2524535|NCT04222699|Primary|Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization|Change in the abundance of Staphylococcus aureus in the nose from immediately before mupirocin administration to 8 weeks after mupirocin administration.|8 weeks|Out of the 28 participants assigned to this group, 2 were lost to follow-up and 1 had an insufficient amount of sample collected and could not be included in the analysis.|||fg/uL||Standard Deviation|Mean
2524536|NCT04218799|Primary|Change in the Abundance of Gram Negative Bacteria on the Femoral Skin After Decolonization|Quantitative PCR using 16s rRNA is used to quantify the total bacterial load of Gram negative bacteria on the femoral skin before and after decolonization.|12 months|Femoral skin samples deteriorated prior to sample analysis and cannot be used.||||||
2524537|NCT04218799|Primary|Change in the Abundance of Gram Negative Bacteria on the Subclavian Skin After Decolonization|Quantitative PCR using 16s rRNA is used to quantify the total bacterial load of Gram negative bacteria on the subclavian skin before and after decolonization.|12 months|Subclavian skin samples deteriorated prior to sample analysis and cannot be used.||||||
2524538|NCT04218799|Primary|Change in the Abundance of Staphylococcus Aureus in the Throat After Decolonization|Change in the abundance of Staphylococcus aureus in the throat from immediately before mupirocin administration to 8 weeks after mupirocin administration.|8 weeks||||fg/uL||Standard Deviation|Mean
2546551|NCT02919995|Secondary|Breath Samples|Exhaled breath pH|8 and 24 hours after treatment|||||||
2524539|NCT04218799|Primary|Change in the Abundance of Staphylococcus Aureus in the Nose After Decolonization|Change in the abundance of Staphylococcus aureus in the nose from immediately before mupirocin administration to 8 weeks after mupirocin administration.|8 weeks||||fg/uL||Standard Deviation|Mean
2524540|NCT04209335|Secondary|Number of Participants Who Have Experienced Non-specific Lower Back Pain|categorical data, experience of nonspecific low back pain up to 6 months before the assessment|up to 6 months before the assessment||||Participants|||Count of Participants
2524541|NCT04209335|Secondary|Physical Activity Level Questionnaire|physical activity level based on national and international recommendations|at the time of testing, last 2 weeks||||Participants|||Count of Participants
2524542|NCT04209335|Secondary|Body Mass Index|weight(kg)/height(cm)2 Value under 18.5 is considered underweight, over 25 overweight, and over 30 obese.|during the time of testing, in 1 h||||units on a scale||Inter-Quartile Range|Mean
2524543|NCT04209335|Primary|Core Muscle Endurance|time in seconds after summing the results of all 4 tests|at the time of testing, in 1 hour||||seconds||Standard Error|Mean
2524544|NCT04204200|Primary|Number of Participants Operated for Complex Regional Pain Syndrome Who Had Total Knee Arthroplasty for Eccentric Arthritis|X-rays of the knee and Schuss profile with an internal and external decoaptation which must be close to 0 cm with pan gonogram standing from the front (x-rays of the long axes of the pelvis of the ankles with measurement of the HKA axes on the prosthesis side and on the non-side operated which must be close to 180°) to have eccentric arthritis.|After one-year follow-up|Among 18 patients who had Total knee arthroplasty for eccentric arthritis, results shows the number of cases operated for complex regional pain syndrome (CRPS)|||participants|||Number
2524545|NCT04204200|Primary|Number of Participants Operated for Complex Regional Pain Syndrome Who Had Internal Unicompartmental Arthroplasty for Centralized Arthritis|Radiographs of the knee in Schuss with an external decoaptation which must be close to 0 cm and a pan gono gram standing from the front|After one-year follow-up|Among 18 patients who had Internal unicompartmental arthroplasty for centralized arthritis, results shows the number of cases operated for complex regional pain syndrome (CRPS)|||participants|||Number
2524546|NCT04204200|Primary|Number of Participants Operated for Complex Regional Pain Syndrome Who Had Ligamentoplasty ACL According to Kenneth-Jones|Radiographs of the knee in monopodial support at 30° flexion (schuss) were taken. Measurement analysis of the translation of the tibia relative to the femur which must be close to 0 cm for the patient to be positive for the outcome.|After one-year follow-up|Among 15 patients who had Ligamentoplasty (ACL) according to Kenneth-Jones, results shows the number of cases operated for complex regional pain syndrome (CRPS)|||participants|||Number
2524547|NCT04204200|Primary|Number of Participants Operated for Complex Regional Pain Syndrome Who Had Transposition of Anterior Tibial Tuberosity|We take an x-ray of the knee then we calculate of the Index of Caton and Deschamps AT / AP which must be close to 1 cm (from the upper edge to the lower edge of the patella which must be equal to the distance between the tip of the patella and anterior tibial tuberosity) to be interpreted as a transposed tuberosity.|After one-year of follow-up|Among 15 patients who had transposition of anterior tibial tuberosity, results shows the number of cases operated for complex regional pain syndrome (CRPS).|||participants|||Number
2524548|NCT04182217|Secondary|Delay in Hospital|the time in days between the date of admission and the date of leaving the hospital|immediately after hospitalization||||days||Standard Deviation|Mean
2524549|NCT04182217|Secondary|Delay in Post-op|the time in days between the date of the intervention and the leaving of the patient at the hospital|immediately after hospitalization|We did not find information in the files on the delay in post-op for 1 patient|||days||Standard Deviation|Mean
2524550|NCT04182217|Secondary|Delay in Pre-op|the pre-operative time in days which describes the time between the date of the intervention and the date of admission|immediately post-surgery|We did not find information in the files on the delay in pre-op for 1 patient|||days||Standard Deviation|Mean
2524551|NCT04182217|Secondary|Onset of Symptoms|Days before coming at the hospital|immediately after admission|We did not find information in the files on the onset of symptoms for 10 patients|||days||Standard Deviation|Mean
2524552|NCT04182217|Primary|Demographic Parameters|Age in years described in the admission file|during admission|||||||
2524553|NCT04182217|Primary|Etiological Diagnosis|final diagnosis retained in the operating protocol|immediately post-surgery|||||||
2524554|NCT04182217|Primary|Blood Pressure|Systolic Blood pressure in mmHg reported in the file of entry|immediately after admission, up to 30 minutes|For the other (21) patients we did not find any data relating to the systolic blood pressure.|||Hg mm||Standard Deviation|Mean
2524555|NCT04182217|Primary|Temperature|Temperature in celsius reported in the file of entry|immediately after admission, up to 30 minutes|For the other (6) patients we did not find any data relating to the temperature|||Celcius||Standard Deviation|Mean
2524556|NCT04182217|Primary|Respiratory Rate|Respiratory rate number of cycle/min reported in the file of entry|immediately after admission, up to 30 minutes|For the other (11) patients we did not find any data relating to the respiratory rate.|||Cycle/min||Standard Deviation|Mean
2524557|NCT04182217|Primary|Heart Rate|Heart rate number of beats/min reported in the file entry for each patients|immediately after admission, up to 30 minutes||||Beats/min||Standard Deviation|Mean
2524558|NCT04179838|Secondary|Cortisol|"Cortisol levels in blood samples (ug/dl) collected in the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention."|"A single time point, in the evening (~19.5 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention."||||ug/dl||Standard Error|Mean
2524559|NCT04179838|Secondary|Insulin|"Insulin levels in blood samples (uU/mL) collected in the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention."|"A single time point, in the evening (~19.5 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention."||||uU/mL||Standard Error|Mean
2524560|NCT04179838|Secondary|Total Calories of Consumed Food|"Total calories (kcal) of the food items consumed at the buffet provided after fMRI scanning in the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention."|"A single time point, in the evening (~20 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention."||||kcal||Standard Error|Mean
2524618|NCT04112069|Other Pre-specified|Percentage of Time in the Glucose Target Range of 70-180 mg/dl||Days 2-5||||percentage of time||Standard Deviation|Mean
2524561|NCT04179838|Secondary|Leptin|"Leptin levels in blood samples (ng/mL) collected in the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention."|"A single time point, in the evening (~19.5 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention."||||ng/mL||Standard Error|Mean
2524562|NCT04179838|Secondary|Ghrelin|"Ghrelin levels in blood samples (ng/mL) collected in the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention."|"A single time point, in the evening (~19.5 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention."||||ng/mL||Standard Error|Mean
2524563|NCT04179838|Secondary|Energy-density of Consumed Food|"Energy-density (kcal/g) of the food items consumed at the buffet provided after fMRI scanning in the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention."|"A single time point, in the evening (~20 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention."||||kcal/g||Standard Error|Mean
2524564|NCT04179838|Primary|Functional Magnetic Resonance Imaging (fMRI)-Based Decoding Accuracy of Food vs Non-food Odors in Piriform Cortex|"In the evening after the night of the Sleep-Deprived and the Non-Sleep Deprived intervention, odor-evoked brain responses were collected using fMRI. fMRI data was analyzed using searchlight-based support vector machines and leave-one-run-out cross-validation to decode information about food vs. non-food odors. For each participant, this resulted in two maps of decoding accuracy (% data points correctly classified as food or non-food odors), one map per intervention. The measure of interest was decoding accuracy extracted from the piriform cortex."|"A single time point, in the evening (~19 h) after both the night of the Sleep-Deprived and the Non-Deprived intervention."||||Percentage correctly classified||Standard Error|Mean
2524565|NCT04150224|Secondary|Number of Subjects With CS Changes in Vital Signs|Safety and tolerability: No. of sbjs with clinically significant changes in vital signs (blood pressure, HR, body temperature, RR)|Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake|Safety population|||participants|||Number
2524566|NCT04150224|Secondary|Relative Degree of Absorption|"f=Cmax(T)/Cmax(R). Test (T) - PBTZ169 640 mg after meals, reference (R) - PBTZ169 640 mg fasted"|Up to 72 hours after the last drug administration||||geometric mean ratio, %||90% Confidence Interval|Geometric Mean
2524567|NCT04150224|Secondary|Relative Bioavailability|f=AUC0-∞(T)/AUC0-∞(R); f'=AUC0-t(T)/AUC0-t(R) Test (T) - PBTZ169 640 mg after meals, reference (R) - PBTZ169 640 mg fasted|Up to 72 hours after the last drug administration||||% of T/R geometric mean ratio||90% Confidence Interval|Geometric Mean
2524568|NCT04150224|Secondary|Elimination Constant Kel||Up to 72 hours after the last drug administration|C1-4 - Single or double dose administration, C5 - Multiple administration for 14 days|||1/h||Standard Deviation|Mean
2524569|NCT04150224|Secondary|Volume of Distribution (Vd/F)||Up to 72 hours after the last drug administration|C1-4 - Single or double dose administration, C5 - Multiple administration for 14 days|||l||Standard Deviation|Mean
2524570|NCT04150224|Secondary|Total Clearance (Clt/F)||Up to 72 hours after the last drug administration|C1-4 - Single or double dose administration, C5 - Multiple administration for 14 days|||l/h||Standard Deviation|Mean
2524571|NCT04150224|Secondary|Area Under the Concentration-time Curve (AUC0-24)|C5 (multiple administration once a day for 14 days): AUC0-24 was calculated based on measurements within 24 hours after PBTZ169 intake|In the dosing interval (up to 24 hours after drug administration)|C5 (multiple administration for 14 days) - AUC0-τ within 72 hours after the last (14th) dose administration|||ng/ml*h||Standard Deviation|Mean
2524572|NCT04150224|Secondary|Area Under the Concentration-time Curve (AUC0-∞)|In the time interval from 0 to infinity|Up to 72 hours after the last drug administration|C1-4 - Single or double dose administration, C5 - Multiple administration for 14 days|||ng*h/ml||Standard Deviation|Mean
2524573|NCT04150224|Secondary|Area Under the Concentration-time Curve (AUC0 t)|"In the time interval from 0 to time (t) when the last blood sample is collected with a concentration above the limit of quantification.~C5: for the data of Day 14 based on measurements within 72 hours after the last dose administration"|Up to 72 hours after the last drug administration|C1-4 - Single or double dose administration, C5 - Multiple administration for 14 days|||ng*h/ml||Standard Deviation|Mean
2524574|NCT04150224|Secondary|Plasma Half-life Time (T1/2)||Up to 72 hours after the last drug administration|C1-4 - Single or double dose administration, C5 - Multiple administration for 14 days|||h||Standard Deviation|Mean
2524575|NCT04150224|Secondary|Time to Reach Maximum Concentration (Tmax)|Cohort 3: Tmax relative to the time of administration in any dosage interval|Up to 72 hours after the last drug administration|C1-4 - Single or double dose administration, C5 - Multiple administration for 14 days|||h||Standard Deviation|Mean
2524576|NCT04150224|Secondary|Trough Concentration With Repeated Administration (Ctrough)|PBTZ169 concentration before drug intake (Days 2 - 15)|Up to 72 hours after the last drug administration||||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2524577|NCT04150224|Secondary|Peak Plasma Concentration (Сmax)|"Сmax of PBTZ169 at the timepoints:~C1A, C1B, C2 and C4: point 0 (-5 min to -1 min), 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 9:00, 12:00, 24:00, 48:00 and 72:00 (h:min).~C3 (two administrations): point 0 (-5 min to -1 min), 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 9:00, 12:00 (the point before the second administration from -5 min to -1 min), 12:30, 13:00, 13:30, 14:00, 15:00, 16:00, 18:00, 21:00, 24:00, 48:00 , 72:00 (h:min) after the first administration of the medicinal product.~C5 (14 days of intake): 5 minutes before the administration (only until the first dose), 0 min and within 24 h after the administration of the 1st, 7th and last (14th) dose: 0:15, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 (h:min after the administration of a dose of the medicinal product); at 48 h and 72 h points after the last (14th) dose of PBTZ169"|In the dosing interval (up to 72 hours after the last drug administration)|C1-4 - Single or double dose administration, C5 - Multiple administration for 14 days|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2524578|NCT04150224|Secondary|Results of Physical Examination: CS Deviations|Safety and tolerability: number of physical examinations with CS deviations in results|Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake|Safety population|||CS physical examination deviations|||Number
2524579|NCT04150224|Secondary|Laboratory Examinations Results (Safety and Tolerability)|Complete blood count, biochemical blood test, urine analysis|Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake||||participants|||Number
2524580|NCT04150224|Secondary|ECG Results (Safety and Tolerability)|Clinically significant abnormal deviations in ECG findings|Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake|Safety population|||participants|||Number
2524581|NCT04150224|Secondary|CS Changes in Vital Signs|Safety and tolerability:Clinically significant changes in vital signs (blood pressure, HR, body temperature, RR)|Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake|Safety population|||No of cases of CS changes in vital signs|||Number
2524582|NCT04150224|Primary|Number of Subjects With AEs|Safety and tolerability: number of subjects with adverse events|Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake|Safety population|||participants|||Number
2524583|NCT04150224|Primary|Number of Adverse Events|Safety and tolerability: number of (S)AEs|Up to last visit time point: C2, C3, C4 up to Day 7; C1 up to Day 13; C5 up to Day 21 after first drug intake|Safety population|||AEs|||Number
2524584|NCT04149925|Secondary|Pain Level|Postoperative pain level as measured by a standard pain severity scale of 0-10 where 0 means no pain and 10 means severe pain.|1 week following procedure||||score on a scale||Standard Deviation|Mean
2524585|NCT04149925|Secondary|Blood Transfusion|Incidence of intraoperative or postoperative blood transfusion within 72 hours of surgery start time|Within 72 hours of surgery start||||Participants|||Count of Participants
2524586|NCT04149925|Secondary|Product Malfunction|Incidence of product malfunction during procedure|During surgery||||Participants|||Count of Participants
2524587|NCT04149925|Secondary|Adverse Events|Incidence of reported device-related adverse events|1 month following procedure||||Participants|||Count of Participants
2524588|NCT04149925|Secondary|Staple Line Leaking|Incidence of postoperative leakage during one-month monitoring period following procedure|1 month following procedure||||Participants|||Count of Participants
2524589|NCT04149925|Primary|Staple Line Bleeding|Intraoperative staple line bleeding as measured by the provided bleeding severity scale (1: No bleeding; 2: Minimal bleeding; 3: Moderate bleeding; 4: Excessive bleeding; 5: Profuse bleeding)|10 seconds after last staple line||||score on a scale||Standard Deviation|Mean
2524590|NCT04149353|Secondary|Performance of Metrics Combining Multiple Features From PET and MR in Prediction of Response to Therapy|Quantitative image measures from PET and MR will be compiled and an optimal linear regression will be derived between the image metrics and the outcome measure from pathology, the RCB score. Prediction performance of the regression relation will be assessed using a leave-one-out cross-validation approach.|Changes in image measures will be assessed from baseline scans, prior to therapy, to post-treatment scans, taken six months after baseline. Pathology data will be obtained post-surgery.|Single subject did not complete the second scan, so outcome measure could not be assessed.||||||
2524591|NCT04149353|Primary|Change in PET Activity Estimates From Pre-treatment to Post-treatment|Primary endpoint is the determination of the potential for PET activity estimates to predict RCB score in comparison with that of dynamic contrast enhanced (DCE) MRI. Treatment response will be determined on final pathological evaluation of the resected specimens by way of the RCB score.|Time Frame: Changes in image measures will be assessed from baseline scans, prior to therapy, to post-treatment scans, taken six months after baseline. Pathology data will be obtained post-surgery.|Single subject did not complete the second scan, so outcome measure could not be assessed.||||||
2524592|NCT04144088|Secondary|Change From Baseline Blood Sugar at Week 4|The investigators use blood sugar to compared the difference between the week 4 and week 0|week 0, week 4|||||||
2524593|NCT04144088|Secondary|Change From Baseline Serum Uric Acid at Week 8|The investigators use serum uric acid to compared the difference between the week 8 and week 0|week 0, week 8|||||||
2524594|NCT04144088|Secondary|Change From Baseline Serum Uric Acid at Week 2|The investigators use serum uric acid to compared the difference between the week 2 and week 0|week 0, week 2|||||||
2524595|NCT04144088|Primary|Serum Uric Acid<6 mg/dL at Week 4|The number of patient serum uric acid <6 mg/dL at week 4|week 4||||Participants|||Count of Participants
2524596|NCT04137627|Secondary|Change in Expression of CD133 as Measured by qRT-PCR Absolute Quantification|Expression of CD133 is measured at the initial period of the study (baseline) and after 3 neoadjuvant chemotherapy cycles are completed using qRT-PCR Absolute Quantification. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point.|1 Year||||Picogram/microliter||Full Range|Median
2524597|NCT04137627|Secondary|Change in Expression of CD44 as Measured by qRT-PCR Absolute Quantification|Expression of CD44 is measured at the initial period of the study (baseline) and after 3 neoadjuvant chemotherapy cycles are completed using qRT-PCR Absolute Quantification. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point.|1 Year||||Picogram/microliter||Full Range|Median
2524598|NCT04137627|Secondary|Change in Expression of miR-210 as Measured by qRT-PCR Absolute Quantification|Expression of miR-210 is measured at the initial period of the study (baseline) and after 3 neoadjuvant chemotherapy cycles are completed using qRT-PCR Absolute Quantification. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point.|1 Year||||Picogram/microliter||Standard Deviation|Mean
2524599|NCT04137627|Secondary|Change in Expression of HIF-1⍺ as Measured by qRT-PCR Absolute Quantification|Expression of HIF-1⍺ is measured at the initial period of the study (baseline) and after 3 neoadjuvant chemotherapy cycles are completed using qRT-PCR Absolute Quantification. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point.|1 Year||||Picogram/microliter||Full Range|Median
2524600|NCT04137627|Primary|Clinical Response as Measured by RECIST 1.1. Criteria|Clinical Response is measured using RECIST 1.1. criteria. CR (Complete response) is defined as disappearance of all target lesion, and pathological lymph node showing reduction of its shortest axis to less than 10 mm. PR (Partial response) is defined as reduction of total target lesion diameter at least by 30%. PD (Progressive disease) is defined as total target lesion diameter increased in size atleast by 20% or 5 mm OR occurence of one new lesion. SD (Stable disease) is defined as absence of reduction or increasing of target lesion. Patients with PR and CR are considered as positive response. Patients with SD and PD are considered as negative response.|1 Year||||Participants|||Count of Participants
2527545|NCT03563313|Secondary|CGM Time Below 70|CGM-measured % below 70 mg/dL|26 weeks||||percentage||Standard Deviation|Mean
2524601|NCT04123665|Other Pre-specified|Number of Bleeding Sites After 12 and 24 Weeks|Number of gingival bleeding sites were measured as part of bleeding index via a single examiner using a color-coded periodontal probe. The probe was engaged approximately 1 mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. For each participant, the scoring system used to measure bleeding sites is as follows: 0= no bleeding after 30 sec, 1= bleeding upon probing after 30 sec, 2= immediate bleeding observed. Lower bleeding sites indicate better results.|At Week 12 and Week 24|Analysis was performed on ITT population [N=91] which included all participants who received study treatment and had at least one post-baseline efficacy measurement. Number analyzed included participants with available data for each specified category.|||Number of bleeding sites||Standard Deviation|Mean
2524602|NCT04123665|Secondary|Evaluation and Comparison of Supra-gingival Plaque Levels Measured by Overall and Inter-proximal Plaque Index (PI) at 12 and 24 Weeks|Turesky Modification of Quigley Hein Plaque Index-to assess plaque on all gradable teeth. Participants rinsed the plaque in dye solution of 5milliliters(mL)of solution for 10 sec, then expectorated and rinsed with 10 mL of water for 10 sec and then expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e.,0-5). Disclosed plaque scored as:0=no plaque, 1=slight flecks of plaque at the cervical margin of the tooth,2=a thin continuous band of plaque (1mm or smaller) at the cervical margin of the tooth, 3=a band of plaque wider than 1mm but covering less than 1/3 of the area, 4=plaque covering at least 1/3 but less than 2/3 of the area,5=plaque covering 2/3 or more of the crown of the tooth. Lower scores indicate better results.|At Week 12 and Week 24|Analysis was performed on ITT population [N=91] which included all participants who received study treatment and had at least one post-baseline efficacy measurement. Number analyzed included participants with available data for each specified category.|||Score on scale||Standard Deviation|Mean
2524603|NCT04123665|Secondary|Evaluation and Comparison of Gingival Health Measured by MGI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks|MGI-to assess gingivitis symptoms on facial, lingual surfaces of each scorable tooth(7in each arch).2 scores recorded buccally/labially(papilla,margin),2lingually/palatally(papilla,margin).Participants stratified based upon gender and baseline MGI score(Low:<=2.00,High:>2.00).Whole mouth mean of MGI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.MGI scoring:0=absence of inflammation, 1=mild inflammation;slight change in color,little change in color;little change in texture of any portion of the marginal or papillary gingival unit,2=mild inflammation;criteria as above plus the entire marginal or papillar gingival unit,3=moderate inflammation;glazing,redness,edema,and/or hypertrophy of the marginal or papillary gingival unit,4=severe inflammation;marked redness,edema and/or hypertrophy of the marginal or papillary gingival unit,spontaneous bleeding,congestion or ulceration. Lower scores indicate better results.|At Week 12 and Week 24|Analysis was performed on a subgroup of ITT population (included all participants who received study treatment and had at least one post-baseline efficacy measurement) that included participants with MGI >2.00 [N=52] . Number analyzed included participants with available data for each specified category.|||Score on scale||Standard Deviation|Mean
2524604|NCT04123665|Secondary|Evaluation and Comparison of Gingival Health Measured by MGI Indices in Low MGI Subgroup (<=2.00) at 12 and 24 Weeks|MGI-to assess gingivitis symptoms on facial, lingual surfaces of each scorable tooth(7in each arch).2 scores recorded buccally/labially(papilla,margin),2lingually/palatally(papilla,margin).Participants stratified based upon gender and baseline MGI score(Low:<=2.00,High:>2.00).Whole mouth mean of MGI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.MGI scoring:0=absence of inflammation, 1=mild inflammation;slight change in color,little change in color;little change in texture of any portion of the marginal or papillary gingival unit,2=mild inflammation;criteria as above plus the entire marginal or papillar gingival unit,3=moderate inflammation;glazing,redness,edema,and/or hypertrophy of the marginal or papillary gingival unit,4=severe inflammation;marked redness,edema and/or hypertrophy of the marginal or papillary gingival unit,spontaneous bleeding,congestion or ulceration. Lower scores indicate better results.|At Week 12 and Week 24|Analysis was performed on a subgroup of ITT population (included all participants who received study treatment and had at least one post-baseline efficacy measurement) that included participants with MGI <=2.00 [N=39] . Number analyzed included participants with available data for each specified category.|||Score on scale||Standard Deviation|Mean
2524605|NCT04123665|Secondary|Evaluation and Comparison of Gingival Health Measured by Modified Gingival Index (MGI) at 12 and 24 Weeks|MGI- to assess visual symptoms of gingivitis on facial and lingual surfaces of each scorable tooth (7 in each arch). 2scores recorded buccally/labially, 2scores lingually/palatally. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e.,0-4). Scoring was performed using standard dental light:0=absence of inflammation,1=mild inflammation;slight change in color,little change in color; little change in texture of any portion of the marginal or papillary gingival unit,2=mild inflammation; criteria as above plus the entire marginal or papillar gingival unit,3=moderate inflammation;glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit,4=severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit,spontaneous bleeding,congestion,or ulceration. Lower scores indicate better results.|At Week 12 and Week 24|Analysis was performed on ITT population [N=91] which included all participants who received study treatment and had at least one post-baseline efficacy measurement. Number analyzed included participants with available data for each specified category.|||Score on scale||Standard Deviation|Mean
2524619|NCT04112069|Other Pre-specified|Percentage of Time Where CGM Glucose is Less Than 70 mg/dL||Day 2-5||||percentage of time||Inter-Quartile Range|Mean
2524620|NCT04112069|Primary|Percentage of Time With CGM Glucose Values <54 mg/dl||Days 2-5||||percentage of time||Inter-Quartile Range|Mean
2524621|NCT04112069|Primary|Mean CGM Glucose|Mean of all CGM data obtained with the Dexcom G5 through days 2-5 of the study|Days 2-5||||mg/dl||Standard Deviation|Mean
2524641|NCT04083404|Primary|Attainment of Employment or Education|successful attainment of open employment or educational opportunity / unsuccessful|1day||||Participants|||Count of Participants
2524670|NCT04061694|Primary|Pink Esthetic Score|Pink Esthetic Score (PES) Soft-tissue aesthetic scale. Range 0-14. Min = 0, aesthetic failure. Max = 14, almost prefect aesthetic outcome.|12 months||||score on a scale||Standard Deviation|Mean
2524606|NCT04123665|Secondary|Evaluation and Comparison of Gingival Health Measured by BI Indices in High MGI Subgroup (>2.00) at 12 and 24 Weeks|BI-to assess bleeding elicited on probing as measure of gingival condition.Gingivae were air dried,examiner assessed bleeding using probe gently inserted into gingival crevice to depth of app.1mm and run around tooth(at angle of app.60deg to long axis of tooth),gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium.BI assessed on facial,lingual gingival surfaces of each scorable tooth(7in each arch).3scores recorded buccally/labially and 3lingually/palatally. All scorable teeth in 1quadrant probed first(app.30sec)before recording number of gingival units which bled.Participants stratified based upon gender and baseline MGI score(Low:<=2.00,High: >2.00).Whole mouth mean of BI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.BI scoring:0=no bleeding after 30sec,1=bleeding upon probing after 30sec,2=immediate bleeding observed. Lower scores- better results.|At Week 12 and Week 24|Analysis was performed on a subgroup of ITT population (included all participants who received study treatment and had at least one post-baseline efficacy measurement) that included participants with MGI >2.00 [N=52] . Number analyzed included participants with available data for each specified category.|||Score on scale||Standard Deviation|Mean
2524607|NCT04123665|Secondary|Evaluation and Comparison of Gingival Health Measured by BI Indices in Low MGI Subgroups (<=2.00) After 12 and 24 Weeks|BI-to assess bleeding elicited on probing as measure of gingival condition.Gingivae were air dried,examiner assessed bleeding using probe gently inserted into gingival crevice to depth of app.1mm and run around tooth(at angle of app.60deg to long axis of tooth),gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium.BI assessed on facial,lingual gingival surfaces of each scorable tooth(7in each arch).3scores recorded buccally/labially and 3lingually/palatally. All scorable teeth in 1quadrant probed first(app.30sec)before recording number of gingival units which bled.Participants stratified based upon gender and baseline MGI score(Low:<=2.00,High: >2.00).Whole mouth mean of BI calculated by-taking average overall tooth sites assessed;to compare magnitude of differences in two strata.BI scoring:0=no bleeding after 30sec,1=bleeding upon probing after 30sec,2=immediate bleeding observed. Lower scores- better results.|At Week 12 and Week 24|Analysis was performed on a subgroup of ITT population (included all participants who received study treatment and had at least one post-baseline efficacy measurement) that included participants with MGI <=2.00 [N=39] . Number analyzed included participants with available data for each specified category.|||Score on scale||Standard Deviation|Mean
2524608|NCT04123665|Secondary|Evaluation and Comparison of Gingival Health Measured by BI at 12 Weeks|BI-to assess bleeding elicited on probing as a measure of gingival condition. Gingivae were air dried and examiner assessed bleeding using a probe which was gently inserted into gingival crevice to depth of app 1 mm and run around tooth (angle of app 60 deg to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI assessed on facial and lingual gingival surfaces of each scorable tooth (7in each arch). 3 scores were recorded buccally/ labially, 3scores lingually/ palatally. All scorable teeth in one quadrant were probed first (app 30 sec) before recording number of gingival units which bled. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values (i.e.,0-2). BI score:0=no bleeding after 30 sec, 1=bleeding upon probing after 30 sec,2=immediate bleeding observed. Lower scores indicate better results.|At Week 12|ITT population [N=91] included all participants who were enrolled and randomly allocated to treatment and are analyzed in the groups to which they were randomized.|||Score on scale||Standard Deviation|Mean
2524609|NCT04123665|Primary|Evaluation and Comparison of Gingival Health Measured by Bleeding Index (BI) at 24 Weeks|BI-to assess bleeding elicited on probing as a measure of gingival condition. Gingivae were air dried and examiner assessed bleeding using a probe which was gently inserted into gingival crevice to depth of approximately(app)1millimeter(mm)and run around tooth(angle of app60[degrees(deg)] to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI assessed on facial and lingual gingival surfaces of each scorable tooth(7in each arch). 3scores were recorded buccally/labially,3scores lingually/palatally. All scorable teeth in one quadrant were probed first(app30seconds[sec])before recording number of gingival units which bled. Values presented as means across all tooth surfaces with minimum and maximum scores in agreement with minimum and maximum index values(i.e.,0-2).BI score:0=no bleeding after30sec,1=bleeding upon probing after30sec,2=immediate bleeding observed. Lower scores indicate better results.|At Week 24|Intent-to-treat (ITT) population [N=91] included all participants who received study treatment and had at least one post-baseline efficacy measurement. Number analyzed in this outcome measure signifies those who were evaluated.|||Score on scale||Standard Deviation|Mean
2524610|NCT04113785|Primary|Lateral Condyle Translations During Deep Knee Bend Activity|Anterior Posterior (AP) translations of lateral femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.|at least 6 months post-operative||||mm||Standard Deviation|Mean
2524611|NCT04113785|Primary|Medial Condyle Translations During Deep Knee Bend Activity.|Anterior Posterior (AP) translations of medial femoral condyle during deep knee bend. Positive indicates anterior sliding and negative indicates posterior rollback.|at least 6 months post-operative||||mm||Standard Deviation|Mean
2524612|NCT04113785|Primary|Maximum Weight-bearing Flexion During Deep Knee Bend|Maximum weight-bearing flexion that the subjects are able to achieve during deep knee bend. All values are positive.|at least 6 months post-operative||||degrees||Standard Deviation|Mean
2524613|NCT04113785|Primary|Axial Rotation (AR) During Deep Knee Bend|Rotation of femoral component with respect to tibial component during deep knee bend. Positive indicated external rotation of femur wrt tibia.|at least 6 months post-operative||||degrees||Standard Deviation|Mean
2524614|NCT04112069|Other Pre-specified|Number of Episodes of Diabetic Ketoacidosis (DKA)|pre-specified to report the total number of episodes summed across all participants|Day 1-5||||number of episodes|||Number
2524615|NCT04112069|Other Pre-specified|Number of Episodes of Severe Hypoglycemia|Pre-specified to report the total number of episodes summed across all participants|Day 1-5||||number of episodes|||Number
2524616|NCT04112069|Other Pre-specified|Percentage of Time Where CGM Glucose is Less Than 60 mg/dL||Day 2-5||||percentage of time||Inter-Quartile Range|Mean
2524617|NCT04112069|Other Pre-specified|Percentage of Time Where CGM Glucose is Greater Than 250 mg/dL||Day 2-5||||percentage of time||Inter-Quartile Range|Mean
2549898|NCT02847182|Secondary|Incidence of Product-related Infections||12 months|||||||
2524622|NCT04109703|Other Pre-specified|Pain Relief 30 Minutes After the Intervention|Numerical Pain Scale Range Zero (minimum) through ten (maximum score) In this study a lower number on the Numeric Pain Scale means the subject(s) has less pain. Less pain particularly in the experimental group is a better outcome.|Changes in the Numerical Pain Scale will be compared between baseline and thirty minutes post intervention.|All subjects with longstanding chronic low back pain median duration 10 years. Subjects who received the high level pulsed heat device with heat pulses up to 45 degrees C. Steady heat subjects received a device that heated to 37 degrees C at a steady level.|||units on a scale||Standard Error|Mean
2524623|NCT04109703|Primary|Pain Rating|Numerical Pain Score (NPS) Range Zero (minimum) through ten (maximum score) thirty minutes after completion of the treatment session.|Changes in the Numerical Pain Scale will be compared between baseline and 30 minutes after minutes of treatment.||||reduction in pain score on a scale||Standard Error|Mean
2524624|NCT04106817|Secondary|Number and Severity of AEs|The number of AEs in each Cohort rated as mild, moderate, or severe intensity|Day 60||||events|||Number
2524625|NCT04106817|Primary|Seroconversion|Greater than or equal to 4-fold rise in HAI titer by study Day 60 relative to baseline|Day 60||||Participants|||Count of Participants
2524626|NCT04106817|Primary|Viral Shedding|Number of participants with viral shedding, assessed from nasopharyngeal swabs using RT-PCR and cell culture assay|Day 9||||Participants|||Count of Participants
2524627|NCT04098809|Secondary|Number of Participants Experiencing Bladder Neck Contracture|Number of Incidence of participants experiencing bladder neck contracture.|1 year||||Participants|||Count of Participants
2524628|NCT04098809|Secondary|Number of Participants Experiencing Bladder Neck Contracture|Number of incidence of participants experiencing bladder neck contracture.|week 12||||Participants|||Count of Participants
2524629|NCT04098809|Secondary|Patient Reported Number of Pads Used Per Day.|Patient reported number of incontinence pads used per day. The lower the number the better the outcome.|Week 12||||number of pads||Standard Deviation|Mean
2524630|NCT04098809|Secondary|Number of Incontinence Pads Used|Patient reported number of incontinence pads used per day. The lower the number the better the outcome.|week 6||||number of pads||Standard Deviation|Mean
2524631|NCT04098809|Secondary|Home Opioid Use in Standard Morphine Equivalency|Patient reported use of the number of tablets taken from provided prescription of opioids for post-operative pain. This will be converted to a standardized morphine equivalency for comparison. The lower the value the better the outcome.|after discharge until post-op day 7||||milligrams||Standard Deviation|Mean
2524632|NCT04098809|Secondary|Opioid Use|Patient reported use of the number of tablets taken from provided prescription of opioids for post-operative pain. This will be converted to a standardized morphine equivalency for comparison. The lower the value the better the outcome.|after discharge until post-op day 7||||tablets||Standard Deviation|Mean
2524633|NCT04098809|Secondary|Quality of Life Score|Question eight of the International Prostate Symptom Score (IPSS) refers to the patient's perceived quality of life. The range is from delighted with a score of zero to terrible with a score of 6. The lower the score the better the outcome|Week 12||||score on a scale||Standard Deviation|Mean
2524634|NCT04098809|Secondary|Urinary Symptoms|"The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).The lower the score the better the outcome.~Question eight refers to the patient's perceived quality of life. The range is from delighted with a score of zero to terrible with a score of 6. The lower the score the better the outcome."|week 12||||score on a scale||Standard Deviation|Mean
2524635|NCT04098809|Secondary|Quality of Life Score|Question eight of IPSS refers to the patient's perceived quality of life. The range is from delighted with a score of zero to terrible with a score of 6. The lower the score the better the outcome.|Week 6||||score on a scale||Standard Deviation|Mean
2524636|NCT04098809|Secondary|Urinary Symptoms|The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).The lower the score the better the outcome.|week 6||||score on a scale||Standard Deviation|Mean
2524637|NCT04098809|Primary|Catheter Related Pain: Visual Analog Score Rating|Catheter related pain was measured using a visual analog score rating mean post-operative pain on a scale from 1 (no pain) to 10 (worst possible pain). The lower the score the better the outcome.|post-op day 5-7||||score on a scale||Standard Deviation|Mean
2524638|NCT04091659|Secondary|Change in Opioid Overdose Attitudes Scale (OOAS) From Pre- to Post-training|The OOAS subscales assessing competencies to manage an opioid overdose (5 items). Study participants were given intranasal naloxone, so all items were adapted to refer to intranasal naloxone rather than injectable naloxone. OOAS items were scored on a Likert-type scale and higher scores suggested more favorable attitudes towards opioid overdose response, where 1=completely disagree, and 5=completely agree|Immediately Pre-Training and Within 1 Hour Post-training|Higher difference in scores indicates greater improvement from baseline to follow up|||units on a scale||Inter-Quartile Range|Median
2524639|NCT04091659|Primary|Change in Opioid Overdose Knowledge Scale (OOKS) From Pre- to Post-training|Higher scores on the OOKS indicate greater knowledge on how to identify and appropriately intervene during an opioid related overdose, including proper use of naloxone. The tool has been validated with healthcare professionals and lay persons and used to assess changes in knowledge and attitudes after in-person naloxone trainings. This main outcome of this study is examining changes in the OOKS subscale for signs of an opioid overdose with scores ranging from 0 to 10.|Immediately Pre-Training and Within 1 Hour Post-training|Higher difference in scores indicates greater improvement from baseline to follow up|||units on a scale||Inter-Quartile Range|Median
2524640|NCT04083404|Other Pre-specified|Time to Attainment of Employment or Education|Time to outcome for those successfully attaining employment or education|1day-69months||||months||Inter-Quartile Range|Median
2524671|NCT04061694|Primary|MBL|Marginal bone loss MBL, measured in mm from implant abutment junction.|12 months||||mm||Standard Deviation|Mean
2524642|NCT04082819|Primary|Difference Between Diastolic Manual and Device Blood Pressure Readings|Each device reading was compared to the manual reading before (R1) and after (R2) it, to calculate the degree of alignment. The difference of the device and R1, and the device and R2 were taken. The smaller number was used for results reporting.|45-60 minutes|The overall participants analyzed indicate the number of individuals who matched the ranges listed in the description for low, medium or high blood pressure categories, where they had blood pressure ranges falling between the respective values indicated for the diastolic pressure measured.|||mmHg||Standard Deviation|Mean
2524643|NCT04082819|Primary|Difference Between Systolic Manual Sphygmomanometer and Finger Pulse Oximeter Readings|Each device reading was compared to the manual blood pressure reading taken before (R1) and after it (R2). The degree of alignment for systolic blood pressure was calculated by taking the difference between the two scores (manual and device). The reading with the best alignment was used.|45 - 60 minutes|The overall participants analyzed indicate the number of individuals who matched the ranges listed in the description for low, medium or high blood pressure categories, where they had blood pressure ranges falling between the respective values indicated for the systolic pressure measured.|||mmHg||Standard Deviation|Mean
2524644|NCT04081961|Primary|Protocol Adherence|Adherence to the study protocol is determined as the proportion of participants enrolled from whom all mHealth parameters registered every day.|through study completion, an average of 90 days||||Participants|||Count of Participants
2524645|NCT04081961|Primary|Rate of Retention|Retention is defined as the proportion of participants enrolled who completed the intervention and all study measures.|through study completion, an average of 90 days|Participants recruited to the study|||Participants|||Count of Participants
2524646|NCT04081961|Primary|Rate of Recruitment|Recruitment is defined as the number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.|Baseline|The number of potential participants screened for study eligibility|||Participants|||Count of Participants
2524647|NCT04080297|Secondary|Symptoms Associated With Postmenopausal Status|Greene Climacteric Scale: A comprehensive assessment divided into psychological, physical and vasomotor areas. The scale includes 21 symptoms, subject will score the severity of each symptom with the following score system: 0 = not at all; 1 = a little; 2 = quite a bit; and 3 = extremely. The results represent the total combined score, which can range from 0 to 63. A lower score represents a better outcome.|Baseline and 4 weeks|Analyses were performed using the intent-to-treat (ITT) population. The ITT population was defined as all subjects who received at least one dose of study medication and had an evaluable primary or secondary efficacy measurement after baseline.|||score on a scale||Standard Deviation|Mean
2524648|NCT04080297|Secondary|Percent Change in Hot Flash Severity Score|For moderate-to-severe (mod/sev) hot flashes (HF), a score will be calculated by multiplying the number of moderate-to-severe HFs by their severity to determine the HF (mod/sev) index score, using the following formula: HFSSmod/sev = (number of moderate hot flashes/day × 2) + (number of severe hot flashes/day x 3). The Average Daily HFSSmod/sev for each week will be calculated by dividing the total of daily HFSSmod/sev by the number of days observations will be recorded in that week.|Baseline to 4 weeks|Analyses were performed using the intent-to-treat (ITT) population.|||Percent change||Standard Deviation|Mean
2524649|NCT04080297|Secondary|Change in Hot Flash Severity Score|For moderate-to-severe (mod/sev) hot flashes (HF), a score will be calculated by multiplying the number of moderate-to-severe HFs by their severity to determine the HF (mod/sev) index score, using the following formula: HFSSmod/sev = (number of moderate hot flashes/day × 2) + (number of severe hot flashes/day x 3). The Average Daily HFSSmod/sev for each week will be calculated by dividing the total of daily HFSSmod/sev by the number of days observations will be recorded in that week. The change in score is of clinical significance, with a lower score representing less moderate to severe hot flashes and a higher score representing a greater number of moderate to severe hot flashes.|Baseline to 4 weeks|Analyses were performed using the intent-to-treat (ITT) population. The ITT population was defined as all subjects who received at least one dose of study medication and have an evaluable primary or secondary efficacy measurement after baseline.|||Hot flash severity score (HFSS)/day||Standard Deviation|Mean
2524650|NCT04080297|Primary|Percent Change in Frequency of Moderate to Severe Vasomotor Symptoms.|Percent reduction in frequency of moderate to severe vasomotor symptoms. Daily patient (paper) diaries will be used as the primary efficacy collection tool. The hot flash severity categories are defined clinically as follows: mild, sensation of heat without perspiration; moderate, sensation of heat with perspiration, but subject is able to continue with activity; and severe, sensation of heat with sweating, sufficiently severe to result in discontinuation of activity.|Baseline to 4 weeks|Analyses were performed using the intent-to-treat (ITT) population.|||Percent change||Standard Deviation|Mean
2524651|NCT04080297|Primary|Change in Frequency of Moderate to Severe Vasomotor Symptoms.|Mean change in frequency of moderate to severe vasomotor symptoms. Daily patient (paper) diaries will be used as the primary efficacy collection tool. Change from baseline represents the mean change from the daily average frequency calculated at baseline to the daily average frequency calculated for the last week the subject was on drug. The hot flash severity categories are defined clinically as follow: mild, sensation of heat without perspiration; moderate, sensation of heat with perspiration, but subject is able to continue with activity; and severe. sensation of heat with sweating, sufficiently severe to result in discontinuation of activity.|Baseline to 4 weeks|Analyses were performed using the intent-to-treat (ITT) population.|||Hot flashes/day||Standard Deviation|Mean
2524652|NCT04080297|Primary|Serious Adverse Event (SAE) Reporting of Q-122|Number of participants with indicated SAE receiving Q-122|4 weeks|Analyses were performed using the results from the safety analysis population.|||Participants|||Count of Participants
2524653|NCT04080297|Primary|Adverse Event (AE) Reporting of Q-122|Number of participants with indicated AE receiving Q-122|4 weeks|Analyses were performed using the results from the safety analysis population.|||Participants|||Count of Participants
2524668|NCT04061694|Primary|Oral Health Impact Profile - 14|Oral health impact profile - 14 (OHIP-14) Oral health related quality of life questioner. Score range 14-70. Low score indication good oral health related quality of life. High score indicates the opposite.|12 months||||score on a scale||Standard Deviation|Mean
2524669|NCT04061694|Primary|White Esthetic Score|White Esthetic Score (WES) Dental crown/tooth aesthetic scale. Range 0-10. Min = 0, aesthetic failure. Max = 10, almost prefect aesthetic outcome.|12 months||||score on a scale||Standard Deviation|Mean
2524654|NCT04076787|Primary|Percentage of Participants With Stable Disease|Stable disease was defined as no change in size of visible disease. According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), stable disease neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive disease: - at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. PR are those with at least 30 percent (%) decrease in the sum of diameters of the target lesions taking as a reference the baseline sum diameters.|60 months|Analysis population included all adult participants with clear mRCC treated with first-line sunitinib. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||percentage of participants|||Number
2524655|NCT04076787|Primary|Percentage of Participants With Progressive Disease|Progressive disease (PD) was defined as an increase in visible disease. According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) progressive disease: - at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|60 months|Analysis population included all adult participants with clear mRCC treated with first-line sunitinib. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||percentage of participants|||Number
2524656|NCT04076787|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter. PR are those with at least 30 percent (%) decrease in the sum of diameters of the target lesions taking as a reference the baseline sum diameters.|60 months|Analysis population included all adult participants with clear mRCC treated with first-line sunitinib. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||percentage of participants|||Number
2524657|NCT04076787|Primary|Number of Participants Who Discontinued First-Line Sunitinib Treatment|In this outcome measure, participants who discontinued treatment due to any reason like disease progression, death, toxicity, both disease progression and toxicity, other or end of data availability are reported.|60 months|Analysis population included all adult participants with clear mRCC treated with first-line sunitinib. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2524658|NCT04076787|Primary|Time to First-Line Sunitinib Treatment Discontinuation|Time to treatment discontinuation was defined as the time between index date and either discontinuation of first-line sunitinib therapy due to any reason including disease progression, death, toxicity, both disease progression and toxicity, other or end of data availability. The index date was defined as the date of initiation of first-line sunitinib therapy.|60 months|Analysis population included all adult participants with clear mRCC treated with first-line sunitinib. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2524659|NCT04076787|Primary|Overall Survival|Overall survival was defined as the time between index date and death due to any cause or end of data availability. The index date was defined as the date of initiation of first-line sunitinib therapy.|60 months|Analysis population included all adult participants with clear mRCC treated with first-line sunitinib. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2524660|NCT04072432|Primary|Urinary Ferritin Measurement Taken at 168 Hours|Effect of FeS on ferritin measurement of the urine after 168 hours|7 days||||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2524661|NCT04071392|Secondary|Tolerance of 10 ml Saline Infusion|"After placement of the hysterosalpingogram catheter, investigators use an infusion pump to deliver normal saline under continuous pressure monitoring until reaching one of the following endpoints: delivery of the entire volume of 10mL (milliliter); a peak pressure of 450mmHg (millimeters of Mercury); or the participant requested the infusion to stop due to intolerable discomfort.~The proportion of participants who tolerated the full 10 ml of infused saline was compared between groups."|5 minutes||||Participants|||Count of Participants
2524662|NCT04071392|Primary|Intrauterine Fluid Volume Lost|"After placement of the hysterosalpingogram catheter, investigators use an infusion pump to deliver normal saline under continuous pressure monitoring until reaching one of the following endpoints: delivery of the entire volume of 10mL (milliliter); a peak pressure of 450mmHg (millimeters of Mercury); or the participant requested the infusion to stop due to intolerable discomfort.~After one minute, investigators withdraw the delivered fluid through the hysterosalpingogram catheter and record the volume instilled and recovered. They then repeat the procedure using contrast under fluoroscopy to confirm tubal patency or occlusion."|5 minutes||||ml||Inter-Quartile Range|Median
2524663|NCT04069221|Primary|OZ439 AUC0-inf|Area under the OZ439 plasma concentration time curve from time zero to infinity|Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 168, 216, 264, 312 hours post-dose||||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2524664|NCT04069221|Primary|OZ439 AUC0-168h|Area under the OZ439 plasma concentration time curve from time zero to 168h|Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 168 hours post-dose||||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2524665|NCT04069221|Primary|OZ439 C168h|OZ439 concentration observed at 168h|168 hours post-dose||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2524666|NCT04069221|Primary|OZ439 Cmax|OZ439 maximum concentration observed|Pre-dose, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 168, 216, 264, 312 hours post-dose||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2524667|NCT04069221|Primary|OZ439 Fpo|OZ439 Absolute oral bioavailability|OZ439: Pre-dose, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 168 hours post-dose. [14C]-OZ439: 10, 15, 20, 30 and 45 minutes after start of iv infusion then 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96, 168 hours||||Absolute bioavailability in %||90% Confidence Interval|Geometric Mean
2524672|NCT04061694|Primary|Number of Participants With Implant Survival|Survival of dental implants. Implant survival means that implants are still in the mouth at the time of examination, regardless of the state of the prosthesis or patient satisfaction|12 months||||participants|||Number
2524673|NCT04057235|Secondary|Change in Oswestry Disability Index (ODI) From Baseline to Last Available Follow-up|ODI is used to quantify disability related to lower back pain. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.|From baseline to last available follow-up, with an average follow-up of 4.4 ± 3.8 months (range: 0.5-20.5 mo)|Participants with both baseline and follow-up ODI data|||score on a scale||Standard Deviation|Mean
2524674|NCT04057235|Secondary|Change in Visual Analog Scale (VAS) for Back Pain From Preoperative Baseline to Last Available Follow-up|"Visual analog scale for measuring pain intensity related to back pain. The scale is anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10)."|From baseline to last available follow-up, with an average follow-up of 4.4 ± 4.3 months (range: 0.5-20.5 mo)|Participants who had VAS Back data at both baseline and follow-up|||score on a scale||Standard Deviation|Mean
2524675|NCT04057235|Secondary|Change in Visual Analog Scale (VAS) for Leg Pain From Preoperative Baseline to Last Available Follow-up|"Visual analog scale for measuring pain intensity related to leg pain. The scale is anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10)."|From baseline to last available follow-up, with an average follow-up of 4.6 ± 4.4 months (range: 0.5-20.5 mo)|Participants who had VAS Leg data available at both baseline and follow-up|||score on a scale||Standard Deviation|Mean
2524676|NCT04057235|Primary|Radiographic Arthrodesis|Proportion of participants with radiographic arthrodesis at 12 months +/- 3 months as determined using plain radiographic images with assessment based on the Bridwell-Lenke grading system [Bridwell and Lenke et al, 1995].|12 months +/- 3 months|Participants who had radiographs available at 12 months follow-up|||Participants|||Count of Participants
2524677|NCT04053465|Secondary|Heart Rate|Heart rate was assessed five days following baseline.|5 days||||beats per minute||Standard Deviation|Mean
2524678|NCT04053465|Primary|Internal Body Temperature|Rectal temperature was assessed five days following measurement at baseline.|5 days||||degrees Celcius||Standard Deviation|Mean
2524679|NCT04053270|Secondary|Change in Quality of Life Using SF36 Questionnaire (Mental Component Score) for Study Completers Population|"The Summary of SF36 change from Baseline of Mental Component Score (MCS) to the scores during treatment on Days 60, 120, 180, 240, 300 and 360 using the SF36 questionnaire.~The SF-36 (The Short Form 36 Health Survey) consists of eight scaled scores, which are the weighted sums of the questions in each section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.~The higher scores represent better health-related quality-of-life."|Day0, Day60, Day120, Day180, Day240, Day300, Day360 or Early Termination|The secondary analysis population for efficacy included those subjects who received all required doses of investigational product. This population, which was comprised of 93 patients, is identified as the study completers population.|||score on a scale||Standard Deviation|Mean
2524680|NCT04053270|Secondary|Change in Quality of Life Using SF36 Questionnaire (Physical Component Score) for Study Completers Population|"The Summary of SF36 change from Baseline of Physical Component Score (PCS) to the scores during treatment on Days 60, 120, 180, 240, 300 and 360 using the SF36 questionnaire.~The SF-36 (The Short Form 36 Health Survey) consists of eight scaled scores, which are the weighted sums of the questions in each section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.~The higher scores represent better health-related quality-of-life."|Day0, Day60, Day120, Day180, Day240, Day300, Day360 or Early Termination|The secondary analysis population for efficacy included those subjects who received all required doses of investigational product. This population, which was comprised of 93 patients, is identified as the study completers population.|||score on a scale||Standard Deviation|Mean
2524681|NCT04053270|Secondary|Skin Melanin Density (Study Completers Population)|"Changes in melanin density (MD) (measured by spectrophotometry) at each visit by group.~Participants had their skin pigmentation measured by a non-invasive quantitative skin chromaticity (reflectance) reading. Reflectance by the skin of light measured at the wavelengths of 400 nm and 420 nm was recorded using a Minolta cm-2500d spectrophotometer at the following skin sites: forehead, left cheek, right inside upper arm, left medial forearm, right side of abdomen (avoiding implant insertion site), left side of sacral region/buttock.~Melanin density was determined for each skin site using the method of Dwyer et al 1998."|Day0, Day14, Day30, Day60, Day74, Day90, Day120, Day150, Day180, Day210, Day240, Day270, Day300, Day330, Day360 or Early Termination|"The secondary analysis population for efficacy included those subjects who received all required doses of investigational product. This population is identified as the study completers population.~Calculated MD <0 or >6 were omitted."|||unitless||Standard Deviation|Mean
2524682|NCT04053270|Secondary|Cumulative Number of Days With Sunlight Exposure (Study Efficacy Population)|The number of days with sunlight exposure was recorded in the patient diary. The sunlight exposures were divided into the following categories: none, < 1 hour, 1 to 3 hours, 3 to 6 hours and > 6 hours per day.|0-360 days or Early Termination|The primary analysis population for efficacy was revised, with an additional criterion of a total cumulative pain score of at least 26, and omitting patients who did not complete the study. This population, which was comprised of 60 patients, is identified as the Efficacy population.|||Days|||Number
2524698|NCT04045964|Secondary|Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts||at the time of follow-up visit #1 (about 2 weeks post-intervention)|Only participants who reported current smoking were assessed for this measure. 2 participants in the Motivational Advice and Free NRT arm reported current smoking, and 4 participants in the Quitline Referral arm reported current smoking (between baseline and the follow-up visit #1; i.e., 1 Quitline participant began smoking after baseline).|||Participants|||Count of Participants
2524699|NCT04045964|Secondary|Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by Other Household Members (Other Than the Participant or Participant's Partner)||baseline|Only current smokers were assessed for this measure. 7 household members (other than participant or partner) living with participant in the Motivational Advice and Free NRT arm reported current smoking, and 6 household members (other than participant or partner) living with participant in the Quitline Referral arm reported current smoking.|||Participants|||Count of Participants
2524683|NCT04053270|Primary|The Mean Number of Phototoxic Reactions (Study Efficacy Population)|"The mean number of phototoxic reactions that occurred whilst patients were on active compared with placebo implants.~The days on which the participant experienced pain as a result of phototoxic reactions (caused by exposure to natural light) was recorded in a study diary. On each day such a reaction occurred, the participant scored the level of pain using an 11-point Likert pain scale, with minimum of 0 and maximum of 10. The 11-point Likert pain scale with a value of 0 represents no pain and 10 represents worst imaginable pain.~The primary analysis population for efficacy was revised, to analyze only participants who reported a cumulative total Likert pain score of at least 26 during the study (0-360 days). This population, which was comprised of 60 patients, is identified as the Efficacy population.~Participants with less than 26 Likert pain scores were not included in the analysis."|0-360 days or Early Termination|"The result is reported in a per sequence format with the different time points at which the interventions were switched.~Total of 60 Participants: 32 participants in Group A and 28 participants in Group B."|||counts of episodes||Standard Deviation|Mean
2524684|NCT04053270|Primary|Cumulative Number of Days of Phototoxic Reactions (Study Efficacy Population)|"The cumulative number of days where a phototoxic reaction occurred was recorded in the patient diary. The reported data represent a cumulative total for days of phototoxic reactions.~The participant scored the level of pain using an 11-point Likert pain scale, with minimum of 0 and maximum of 10. The 11-point Likert Pain scale with a value of 0 represents no pain and 10 represents worst imaginable pain.~The primary analysis population for efficacy was revised, to analyze only participants who reported cumulative total Likert pain scores of at least 26 during the study (0-360 days). This population, which was comprised of 60 patients, is identified as the Efficacy population. Participants with less than 26 Likert pain scores were not included in the analysis."|0-360 days or Early Termination|Participants who reported a cumulative total Likert pain score of at least 26 during the study (0-360 days), which was comprised of 60 patients, is identified as the Efficacy population.|||Days|||Number
2524685|NCT04051684|Secondary|Vomiting: The Number of Participants Experiencing Vomiting Will be Assessed by Chart Review|The number of participants experiencing vomiting will be assessed by chart review|Up to 5 hours||||Participants|||Count of Participants
2524686|NCT04051684|Secondary|Nausea: The Number of Participants Experiencing Nausea Will be Assessed by Chart Review|The number of participants experiencing nausea will be assessed by chart review|Up to 5 hours||||Participants|||Count of Participants
2524687|NCT04051684|Secondary|Pain Score Assessed With Visual Analog Score (VAS)|Visual Analog Score (VAS) scores correlate to Pain scores (0-10, 0 being no pain and 10 being the worst pain). VAS will be taken within 30 minutes of arrival to post anesthesia care unit (PACU)|30 minutes within arrival to PACU||||units on a scale||Inter-Quartile Range|Median
2524688|NCT04051684|Primary|Post Operative Opioid Usage|The amounts of opioids used by the patient will be collected by a person blinded to the allocation group|24 hour after surgery||||morphine equivalent||Inter-Quartile Range|Median
2524689|NCT04048681|Secondary|Neurocognitive Testing (Stop Signal Reaction Time)|stop signal reaction time is a measure of inhibitory control, where a shorter stop signal reaction time indicates greater inhibitory control.|1 hour||||ms||Standard Error|Mean
2524690|NCT04048681|Primary|Changes in Brain Response to Food Cues in the Insula|Functional magnetic resonance imaging (BOLD signals) while patients view food vs. non-food cues. The effect size z-score represents the magnitude of the activation in that area to food cues vs. non-food cues. The z-score is the estimated response magnitude in that area compared to the overall mean. Negative numbers indicate values lower than the mean and positive numbers indicate values above the mean.|1 hour||||z-score||Standard Error|Mean
2524691|NCT04045964|Secondary|Car Smoking Ban Status, as Measured by Number of Participants Who Report a Car-smoking Ban.||From time of randomization to follow-up visit #2 (generally completed within 2-3 months)||||Participants|||Count of Participants
2524692|NCT04045964|Secondary|Home Smoking Ban Status, as Measured by Number of Participants Who Report a Home-smoking Ban.||From time of randomization to follow-up visit #2 (generally completed within 2-3 months)||||Participants|||Count of Participants
2524693|NCT04045964|Secondary|Smoking Quit Attempts, as Measured by Number of Other Household Members (Other Than the Participant or the Participant's Partner) Who Reported One or Greater Quit Attempts||at the time of follow-up visit #2 (about 1 month post-intervention)|For the Motivational advice and free NRT arm, 7 household members (other than the participant or the participant's partner) reported current smoking at baseline. For the Motivational advice and free NRT arm, 6 household members (other than the participant or the participant's partner) reported current smoking at baseline.|||Participants|||Count of Participants
2524694|NCT04045964|Secondary|Smoking Quit Attempts, as Measured by Number of Other Household Members (Other Than the Participant or the Participant's Partner) Who Reported One or Greater Quit Attempts||at the time of follow-up visit #1 (about 2 weeks post-intervention)|For the Motivational advice and free NRT arm, 7 household members (other than the participant or the participant's partner) reported current smoking at baseline. For the Motivational advice and free NRT arm, 6 household members (other than the participant or the participant's partner) reported current smoking at baseline.|||Participants|||Count of Participants
2524695|NCT04045964|Secondary|Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts||at the time of follow-up visit #2 (about 1 month post-intervention)|For each arm, 12 partners reported current smoking at baseline.|||Participants|||Count of Participants
2524696|NCT04045964|Secondary|Smoking Quit Attempts, as Measured by Number of Participant's Partners Who Reported One or Greater Quit Attempts||at the time of follow-up visit #1 (about 2 weeks post-intervention)|For each arm, 12 partners reported current smoking at baseline.|||Participants|||Count of Participants
2524697|NCT04045964|Secondary|Smoking Quit Attempts, as Measured by Number of Participants Who Reported One or Greater Quit Attempts||at the time of follow-up visit #2 (about 1 month post-intervention)|Only participants who reported current smoking were assessed for this measure. 2 participants in the Motivational Advice and Free NRT arm reported current smoking, and 4 participants in the Quitline Referral arm reported current smoking (between baseline and the follow-up visit #2; i.e., 1 Quitline participant began smoking after baseline).|||Participants|||Count of Participants
2525032|NCT03894449|Secondary|Change in Immunoglobulins (IgE) From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||IU/mL||Standard Deviation|Mean
2524700|NCT04045964|Secondary|Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant's Partner||baseline|Only current smokers were assessed for this measure. 12 partners of participants in the Motivational Advice and Free NRT arm reported current smoking, and 12 partners of participants in the Quitline Referral arm reported current smoking.|||Participants|||Count of Participants
2524701|NCT04045964|Secondary|Cigarette Use (Point Prevalence), as Measured by Number of Cigarettes Smoked Per Day by the Participant||Baseline|Only current smokers (at Baseline) were assessed on this measure; 2 reported current smoking (Motivational Advice and Free NRT arm); 3 reported current smoking (Quitline Referral arm). A 4th Quitline participant began smoking after data were collected; therefore, number of cigarettes/day at baseline was not collected for this 4th participant.|||Participants|||Count of Participants
2524702|NCT04045964|Primary|Efficacy as Assessed by the Number of Participants Who Reported That Anyone in Their Household Used NRT.||From time of randomization to follow-up visit #2 (generally completed within 2-3 months)||||Participants|||Count of Participants
2524703|NCT04045964|Primary|Feasibility as Assessed by Number of Participants Who Accepted NRT Patches From Research Staff.||From time of randomization to intervention session number 2 (generally completed within 2-3 weeks of randomization)||||Participants|||Count of Participants
2524704|NCT04039867|Secondary|Overall Survival of Patients Who Received Gemcitabine and Oxaliplatin|To evaluate overall survival in patients with advanced TCC bladder treated with this combination of gemcitabine and Oxaliplatin.|From date of registration for 5 years or until death from any cause, whichever came first.|All treated patients were included in this analysis.|||days||95% Confidence Interval|Median
2524705|NCT04039867|Secondary|Overall Response Rate as Assessed by RECIST Criteria of Patients Who Received Gemcitabine and Oxaliplatin|To assess the overall response rate to the combination of gemcitabine and Oxaliplatin in patients with recurrent or advanced TCC bladder. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI. Complete Response (CR) is defined as disappearance of all target lestions. Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions. Overall response rate (ORR) is defined as confirmed complete response (CR) and partial response (PR). ORR = CR + PR|From date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.|Only 14 were accessable for response. One subject never started treatment, two dropped out of the study and one died prior to first assessment.|||participants|||Number
2524706|NCT04039867|Primary|Number of Participants With Treatment-emergent Adverse Events to Evaluate Tolerability of Oxaliplatin With Gemcitabine|To evaluate the tolerability of administering Oxaliplatin in combination with gemcitabine in patients with recurrent or advanced TCC bladder. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0.|From date of registration until treatment completion, disease progression or other reasons for removal from protocol treatments, whichever came first, an average of 1 year.|Please refer to the Adverse Event tables for specifics.|||Participants|||Count of Participants
2524707|NCT04039412|Secondary|Rate of Helicobacter Pylori Treatment Completion|Questionnaire to evaluate the compliance with each treatment regimen|10-14 days||||Participants|||Count of Participants
2524708|NCT04039412|Primary|Incidence of Treatment-Emergent Adverse Events|Questionnaire to measure the number of Participants with Treatment-Emergent Adverse Events|10-14 days||||Participants|||Count of Participants
2524709|NCT04039412|Primary|Percentage of Helicobacter Pylori Infection Cure|Measuring the curative rate of each regimen by a fecal antigen test|40-44 days||||Participants|||Count of Participants
2524710|NCT04036838|Primary|Overall Percent Agreement|"The primary study endpoint is the performance measure in initial diagnosis (histology, RUT, culture) compared to the PyloPlus 13C UBT System~Primary outcome of this study is to provide overall percent agreement in initial diagnosis with the PyloPlus 13C UBT System in comparison to other known diagnostic tools (histology, RUT, culture)."|2 Visits||||percentage of pos. agreement||95% Confidence Interval|Number
2524711|NCT04035564|Secondary|Mortality|Death during hospitalization.|Patients will be followed during hospitalization, an expected average of 3 months of age||||Participants|||Count of Participants
2524712|NCT04035564|Secondary|Number of Participants With Intraventricular Hemorrhage|Bleeding into the brain´s ventricular system (intracranial ultrasound).|Patients will be followed during hospitalization, an expected average of 3 months of age||||Participants|||Count of Participants
2524713|NCT04035564|Secondary|Number of Participants With Necrotizing Enterocolitis|"Number of patients with Bell stage II or greater necrotizing enterocolitis~Bell's Staging:~Stage II A:~Gastrointestinal signs: Increasing gastric aspirates, mild abdominal distention, fecal occult blood, absent bowel sounds.~Systemic signs: Temperature instability, apnea, bradycardia, lethargy. Radiological findings: Intestinal dilatation, ileus, pneumatosis intestinalis.~Stage II B:~Gastrointestinal signs: As stage IIA plus abdominal tenderness. Systemic signs: As stage IIA plus metabolic acidosis and thrombocytopenia. Radiological findings: As stage IIA plus portal vein gas and ascites.~Stage III A:~Gastrointestinal signs: As stage IIB plus marked abdominal tenderness and generalised peritonitis.~Systemic signs: As stage IIB plus hypotension and severe apnea. Radiological findings: As stage IIB~Stage III B:~Gastrointestinal signs: As stage IIIA As stage IIIA As stage IIIA plus pneumoperitoneum"|Patients will be followed during hospitalization, an expected average of 3 months of age||||Participants|||Count of Participants
2524714|NCT04035564|Secondary|Number of Participants With Late-onset Sepsis|Positive blood culture and/or 5 days of continuous antimicrobial therapy|Patients will be followed during hospitalization, an expected average of 3 months of age||||Participants|||Count of Participants
2524715|NCT04035564|Secondary|Weight Change|The difference between current weight and initial weight|Initial weight (baseline) vs 72 hours||||Grams||Standard Deviation|Mean
2524716|NCT04035564|Secondary|Change in Serum Sodium|The difference between current serum sodium and initial serum sodium|Initial serum sodium (baseline) vs 72 hours||||mEq/L||Standard Deviation|Mean
2524717|NCT04035564|Secondary|% Weight Change|The difference between initial weight and 72hrs weight, expressed in percentage of birth weight.|Initial weight (baseline) vs 72 hours||||% of birth weight||Standard Deviation|Mean
2524718|NCT04035564|Primary|Hypernatremia|serum sodium >150mEq/L|72 hours||||Participants|||Count of Participants
2524719|NCT04035564|Primary|Hyponatremia|serum sodium <130mEq/L|72 hours||||Participants|||Count of Participants
2524720|NCT04034043|Primary|Percentage of Patients With Adequate Radiographic Cup Osseointegration|Percentage of patients with a good osseointegration defined by the criteria described by Moore et al. Measurement technique: qualitative visual assessment of 5 binary parameters (yes/no): radial trabeculae, stress shielding, superolateral buttress, inferomedial buttress, absence of radiolucent lines. Adequate osseointegration: at least 3 parameters are present. Total scale: 0%-100%. Best performance (every patient has adequate osseointegration at 10 years): 100|10 years-18 years||||Participants|||Count of Participants
2524721|NCT04034043|Primary|Clinical Outcomes of the Hip Implants|WOMAC score (Western Ontario and McMaster Universities Osteoarthritis Index). Total scale: 0-96. Best performance: 96|10 years -18 years||||score on a scale||Standard Deviation|Mean
2524722|NCT04034043|Primary|Clinical Outcomes of the Hip Implants|HHS score (Harris Hip Score). Total scale: 0-100. Best performance: 100|10 years-18 years||||score on a scale||Standard Deviation|Mean
2524723|NCT04034043|Primary|Survival Rates of the Hip Implants|Kaplan Meier curve with 95% confidence intervals|10 years-18 years||||percentage of non-revised implants||95% Confidence Interval|Mean
2524724|NCT04032652|Secondary|Change in Detected 5-ASA With Change in Ingested Asacol Dose|Comparison of 2-week and 5-week 5-ASA as measured thorugh rectal dialysis|5 weeks after starting study|The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available||||||
2524725|NCT04032652|Primary|Detection of 5-ASA|5-ASA to be measured using rectal dialysis technique in-vivo|2 weeks after starting Asacol|The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available||||||
2524726|NCT04027218|Secondary|Number of Participants With Adverse Events|Number of adverse events by visual inspection.|During the study completion,. an average of 30 days.||||Participants|||Count of Participants
2524727|NCT04027218|Secondary|Level of Hemolysis in Absorbance Units|"Detection level of absorbance values of hemolysis in plasma samples. The units of absorbance are dimensionless. The hemolysis in plasma is analyzed by spectrophotometry method, using a NanoDrop® 2000 Spectrophotometer device (Thermo Fisher Scientific Inc., Wilmington, United States of America).~The following equation was used to correct lipemia: (A414-A385) +0.16xA385. Additionally, a baseline correction factor at 750 nanometer wavelength was applied. Therefore, absorbance were measured at 414 nanometer, 385 nanometer and 750 nanometer.~Higher values represent a worse outcome: higher value mean higher hemolysis in a blood sample.~Therefore, lower values, near to zero are better outcomes that mean low hemolysis in blood sample."|up to 9 days after first intervention completion||||Absorbance units||Full Range|Median
2524728|NCT04027218|Secondary|Number of Participants in Each Type of Skin Standardized According to Fitzpatrick Scale|"Number of participants in each type of skin standardized according to Fitzpatrick scale. Fitzpatrick scale is the UNABBREVIATED scale that indicates different types of skin described as phototypes. The individuals were graded clinically by sel-expressed by participants in the area of the forearm not exposed to the sun.~In a range of six phototypes, where phototype I corresponds with the minimum and phototype VI the maximum.~Phototype I: Ivory white, burns easily, never tans. Phototype II: White, burns easily, tans minimally with difficulty. Phototype III: White, burns moderately, tans moderately and uniformly Phototype IV: Beige-olive, lightly tanned, burns minimally, tans moderately and easily.~Phototype V: Rarely burns, tans profusely. Phototype VI: Dark brown or black, never burns, tans profusely.~Phototype I was considered more risky outcome for expected adverse events in skin. None was considered better or worse outcome."|up to 2 hours after application of intervention||||Participants|||Count of Participants
2524729|NCT04027218|Secondary|Number of the Grade in Visual Analogue Scale (VAS) for Pain After Intervention|"Visual Analogue Scale (VAS) in pain was measured by integer number. Pain was self-expressed by participants, in a range from 0 to 10.~10: was considered the worst pain experienced 0: no pain perceived.~The entire range was 0, 1, 2, 3, 4, 5 , 6, 7, 8, 9, 10.~Therefore, higher scores mean a worse outcome."|up to 2 hours after application of intervention||||units on a scale||Full Range|Mean
2524730|NCT04027218|Secondary|Number of the Grade of Venous International Assessment (VIA) Scale After Application of Intervention|"Vein perception in VIA scale was considered as the self-reported visual observation or palpation of a venous pathway.~Subjects were graded using the current clinical practice vein stagnation with an elastic compressor application (Unidix®).~Five grades considering the numbers of points of optimal puncture visible and tangible, in one of the dorsal veins of the hand, forearm cephalic and/or basilic.~Grade I: At least six. Grade II: At least four. Grade III: At least three. Grade IV: At least one. Grade V: None.~Therefore, the best grade is I, and the worst grade is V. Higher scores mean a worse outcome."|up to ten minutes after application of intervention||||units on a scale||Full Range|Median
2524731|NCT04027218|Primary|Number of Participants With Successful Venous Catheterization at the First Attempt|Number of participants with successful venous catheterization at the first attempt (effectiveness)|From 1-5 minutes||||Participants|||Count of Participants
2524732|NCT04023695|Primary|Pain Outcome: Visual Analog Scale|Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever|Assessed after 24 hours after injection (by phone)||||units on a scale||Full Range|Mean
2524733|NCT04023695|Primary|Pain Outcome: Visual Analog Scale|Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever|Assessed 1 minute after injection (in clinic)||||score on a scale||Full Range|Mean
2524734|NCT04023578|Primary|6 Minute Walk Test (6MWT)|"The 6MWT is simply a record of the distance traveled by a given patient at his or her self-selected walking speed over a period of six minutes. All that is required is a stopwatch and a walking corridor or track of known distance. Those administering the test should avoid walking with or in front of test subjects to avoid pacing individuals outside of their self-selected walking speed.~The outcome of the test is the distance walked in 6 minutes, in meters."|Measured at baseline and after 3 weeks follow up.|The outcome reported was collected at 3 week follow up on the investigational device.|||Meters||Full Range|Mean
2524754|NCT04015232|Secondary|PD Endpoints for Baseline Adjusted ANC: T[Max]|Time to reach the maximum measured absolute neutrophil count (ANC)|Venous blood samples (2 mL each) were withdrawn at pre-dose and at 8, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7), 240 (Day 11), 336 (Day 15) and 504 (Day 22) following 1st and 2nd dose administration.|Outcome Measure Data Table is breaks participants into negative-ADA or positive-ADA, totaling the overall number of participants by arm|||h||Standard Deviation|Mean
2524735|NCT04019990|Secondary|Measurement of Range of Motion (Absolute Values Are Being Reported)|Shoulder flexion, abduction and external rotation (E.R), internal rotation (İ.R) range of movement will measure in degrees by J-Tech Medical/US Tracker Freedom Goniometer.|All measurements will repeat three times at 5-s intervals and the mean value will be taken. Baseline, 8 and 12 Weeks reported.|12 Wheelchair basketball players and 12 ambulant basketball players Range of Motion (ROM) measurement results in baseline, 8 Weeks and 12 Weeks were compared.|||Degree||Standard Deviation|Mean
2524736|NCT04019990|Primary|Hand Grip Test (Absolute Value Are Being Reported)|Hand-grip strength will measure with a J-Tech Medical/USA Tracker Freedom Grip in kg.|All measurements will repeat three times at 5-s intervals and the mean value will be taken. Baseline, 8 and 12 Weeks reported.|12 Wheelchair basketball players and 12 ambulant basketball players Hand Grip test results in baseline, 8 Weeks and 12 Weeks were compared.|||kg||Standard Deviation|Mean
2524737|NCT04019990|Primary|Medicine Ball Throwing Test (Absolute Values Are Being Reported)|In this test, the distance that a 3-kg ball can be thrown will measure to assess upper-extremity explosive strength. The test will conduct in two different positions. In the first test, the participant will seat in a chair of sufficient height without armrests so that the scapula will be in a free position. The ball is then grasp with both hands and throw forward overhead, and the distance will record. In the second test, the participant is in the same starting position and throw the ball forward with two hands after bringing it to the chest level, and the distance will record.|All measurements will repeat three times at 5-s intervals and the mean value will be taken. Baseline, 8 and 12 Weeks reported.|12 Wheelchair basketball (W.B) players and 12 ambulant basketball (A.B) players medicine ball throwing test results in Baseline, 8 Weeks and 12 Weeks were compared.|||cm||Standard Deviation|Mean
2524738|NCT04019990|Primary|Measurement of Muscle Strength (Absolute Values Are Being Reported)|The strength of shoulder flexion, abduction, external rotation (E.R), internal rotation(İ.R) and elbow flexion will measure as isometric muscle strength in kg by J-Tech Medical/USA Tracker Freedom Isometric Muscle Test.|All measurements will repeat three times at 5-s intervals and the mean value will be taken. Baseline, 8 and 12 Weeks reported.|12 Wheelchair basketball players and 12 ambulant basketball players muscle strength test results in baseline, 8 Week and 12 Week were compared.|||kg||Standard Deviation|Mean
2524739|NCT04018001|Other Pre-specified|Percentage of Participants Who Showed Persistence for Tofacitinib up to 6 Months From the Index Date|Treatment persistence with tofacitinib was defined as participants who did not switch to another advanced therapy or discontinued tofacitinib. Discontinuation of tofacitinib was defined as at least 60 days gap between the run out of prior tofacitinib prescription and subsequent treatment. The run out date was the prescription fill date + day supply -1.|Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)|Analysis was performed on all participants included in the study.|||percentage of participants|||Number
2524740|NCT04018001|Other Pre-specified|Percentage of Participants Who Showed Persistence for Tofacitinib up to 12 Months From the Index Date|Treatment persistence with tofacitinib was defined as participants who did not switch to another advanced therapy or discontinued tofacitinib. Discontinuation of tofacitinib was defined as at least 60 days gap between the run out of prior tofacitinib prescription and subsequent treatment. The run out date was the prescription fill date + day supply -1.|Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)|Analysis was performed on all participants included in the study.|||percentage of participants|||Number
2524741|NCT04018001|Secondary|Percentage of Participants With Adherence to Tofacitinib as Assessed by Greater Than or Equal to (>=) 0.8 Proportion of Days Covered (PDC) up to 12 Months From the Index Date|Adherence was defined as percentage of time with medication on hand. Participants with PDC >=0.8 were considered to show high adherence. PDC was defined as number of days covered by arrays for each fill or administration during the denominator periods of 180 days post-index.|Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)|Analysis was performed on all participants included in the study.|||percentage of participants|||Number
2524742|NCT04018001|Secondary|Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 6 Months From the Index Date|Adherence was defined as percentage of time with medication on hand. Participants with PDC >= 0.8 were considered to show high adherence and participants with PDC <0.8 were considered to show low adherence. PDC was defined as number of days covered by arrays for each fill or administration during the denominator periods of 180 days post-index.|Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)|Analysis was performed on all participants included in the study.|||ratio||Standard Deviation|Mean
2524743|NCT04018001|Secondary|Percentage of Participants With Adherence to Tofacitinib as Assessed by Greater Than or Equal to (>=) 0.8 Medication Possession Ratio (MPR) up to 6 Months From the Index Date|Adherence is defined as percentage of time with medication on hand. Participants with MPR >=0.8 were considered to show high adherence. MPR was calculated as the total days supply between the first and including the last tofacitinib prescription divided by the time between the first through and including last index therapy prescription days supply.|Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)|Analysis was performed on all participants included in the study.|||percentage of participants|||Number
2524744|NCT04018001|Secondary|Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 6 Months From the Index Date|Adherence was defined as percentage of time with medication on hand. Participants with MPR >=0.8 were considered to show high adherence and participants with MPR <0.8 were considered to show low adherence. MPR was calculated as the total days supply of tofacitinib between the first and including the last tofacitinib prescription divided by the time between the first through and including last index therapy prescription days supply.|Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)|Analysis was performed on all participants included in the study.|||ratio||Standard Deviation|Mean
2525033|NCT03894449|Secondary|Change in Immunoglobulins (IgA) From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||g/dL||Standard Deviation|Mean
2524745|NCT04018001|Secondary|Mean Treatment Persistence Duration for Tofacitinib up to 6 Months From Index Date|Treatment persistence with tofacitinib was defined as participants who did not switch to another advanced therapy or discontinued tofacitinib. Discontinuation of tofacitinib was defined as at least 60 days gap between the run out of prior tofacitinib prescription and subsequent treatment. The run out date was the prescription fill date + day supply -1.|Up to 6 months from index date (Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 2.6 years)|Analysis was performed on all participants included in the study.|||days||Standard Deviation|Mean
2524746|NCT04018001|Primary|Primary: Percentage of Participants With Adherence to Tofacitinib as Assessed by Greater Than or Equal to (>=) 0.8 Proportion of Days Covered (PDC) up to 12 Months From the Index Date|Adherence was defined as percentage of time with medication on hand. Participants with PDC >=0.8 were considered to show high adherence. PDC was defined as number of days covered by arrays for each fill or administration during the denominator periods of 360 days post-index.|Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)|Analysis was performed on all participants included in the study.|||percentage of participants|||Number
2524747|NCT04018001|Primary|Mean Adherence to Tofacitinib by Proportion of Days Covered (PDC) up to 12 Months From the Index Date|Adherence was defined as percentage of time with medication on hand. Participants with PDC >= 0.8 were considered to show high adherence and participants with PDC <0.8 were considered to show low adherence. PDC was defined as number of days covered by arrays for each fill or administration during the denominator periods of 360 days post-index.|Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)|Analysis was performed on all participants included in the study.|||ratio||Standard Deviation|Mean
2524748|NCT04018001|Primary|Percentage of Participants With Adherence to Tofacitinib as Assessed by Greater Than or Equal to (>=) 0.8 Medication Possession Ratio (MPR) up to 12 Months From the Index Date|Adherence is defined as percentage of time with medication on hand. Participants with MPR >=0.8 were considered to show high adherence. MPR was calculated as the total days supply between the first and including the last tofacitinib prescription divided by the time between the first through and including last index therapy prescription days supply.|Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)|Analysis was performed on all participants included in the study.|||percentage of participants|||Number
2524749|NCT04018001|Primary|Mean Adherence to Tofacitinib by Medication Possession Ratio (MPR) up to 12 Months From the Index Date|Adherence was defined as percentage of time with medication on hand. Participants with MPR >=0.8 were considered to show high adherence and participants with MPR less than (<) 0.8 were considered as low adherence. MPR was calculated as the total days supply of tofacitinib between the first and including the last tofacitinib prescription divided by the time between the first through and including last index therapy prescription days supply.|Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)|Analysis was performed on all participants included in the study.|||ratio||Standard Deviation|Mean
2524750|NCT04018001|Primary|Mean Treatment Persistence Duration for Tofacitinib up to 12 Months From Index Date|Treatment persistence with tofacitinib was defined as participants who did not switch to another advanced therapy or discontinued tofacitinib. Discontinuation of tofacitinib was defined as at least 60 days gap between the run out of prior tofacitinib prescription and subsequent treatment. The run out date was the prescription fill date + day supply -1.|Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)|Analysis was performed on all participants included in the study. Here “Overall number of participants analyzed” signifies only those participants who had data available.|||days||Standard Deviation|Mean
2524751|NCT04018001|Primary|Percentage of Participants Who Met All Effectiveness Criteria up to 12 Months From the Index Date|Effectiveness criteria: 1) High adherence with proportion of days covered greater than or equal to [>=] 0.8; 2) No increase in index medication dose; 3) No use of an advanced therapy other than index therapy 4) No addition/claims of conventional synthetic disease-modifying antirheumatic drug; 5) If no oral glucocorticoid prescriptions in the 6 months prior to index date, then no more than 30 total days supply of oral glucocorticoids between 3-12 months post index or if at least 1 claim for oral glucocorticoids during 6 months pre-index, then oral glucocorticoid not increased by >=20% between 6-12 months post-index compared to 6 months before index date (6) Participants have one or fewer glucocorticoid injections during 3-12 months after index date. Adherence was defined as percentage of time with medication on hand. Participants who met all 6 effectiveness criteria considered as treated effectively.|Up to 12 months from index date (Index date: date of first claim for tofacitinib by participants to insurance provider during identification period of 2.6 years)|Analysis was performed on all participants included in the study.|||percentage of participants|||Number
2524752|NCT04015232|Secondary|PD Endpoints for Baseline Adjusted ANC: t[1/2]|The terminal half-life will be calculated as 0.693/(lambda-z)|Venous blood samples (2 mL each) were withdrawn at pre-dose and at 8, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7), 240 (Day 11), 336 (Day 15) and 504 (Day 22) following 1st and 2nd dose administration.|Outcome Measure Data Table is breaks participants into negative-ADA or positive-ADA, totaling the overall number of participants by arm|||h||Standard Deviation|Mean
2524753|NCT04015232|Secondary|PD Endpoints for Baseline Adjusted ANC: λz (Lambda-z)|First order rate constant associated with the terminal (log-linear) portion of the curve. This was estimated via linear regression of time vs. log concentration. This parameter was calculated by linear least squares regression analysis using last three or more non-zero plasma concentration values.|Venous blood samples (2 mL each) were withdrawn at pre-dose and at 8, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7), 240 (Day 11), 336 (Day 15) and 504 (Day 22) following 1st and 2nd dose administration.|Outcome Measure Data Table is breaks participants into negative-ADA or positive-ADA, totaling the overall number of participants by arm|||h||Standard Deviation|Mean
2524822|NCT03988426|Secondary|Rate of Episodes of Fever|The number of episodes of fever per person-year of treatment was calculated by the following formula: Total number of episodes of fever / patient-years of Octanorm treatment|Primary Treatment Period (24 Weeks)||||episodes of fever per person-year|||Number
2524755|NCT04015232|Secondary|PD Endpoints for Baseline Adjusted ANC: AUEC[0-t]|Area under the absolute neutrophil count (ANC) versus time curve from time zero to the last measurable concentration as calculated by linear trapezoidal method.|Venous blood samples (2 mL each) were withdrawn at pre-dose and at 8, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7), 240 (Day 11), 336 (Day 15) and 504 (Day 22) following 1st and 2nd dose administration.|Outcome Measure Data Table is breaks participants into negative-ADA or positive-ADA, totaling the overall number of participants by arm|||x10^3cells*h/uL||Standard Deviation|Mean
2524756|NCT04015232|Secondary|PD Endpoints for Baseline Adjusted ANC: E[Max]|Maximum measured absolute neutrophil count (ANC).|Venous blood samples (2 mL each) were withdrawn at pre-dose and at 8, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7), 240 (Day 11), 336 (Day 15) and 504 (Day 22) following 1st and 2nd dose administration.|Outcome Measure Data Table is breaks participants into negative-ADA or positive-ADA, totaling the overall number of participants by arm|||x10^3cells/uL||Standard Deviation|Mean
2524757|NCT04015232|Secondary|PD Endpoints for Baseline Non-adjusted ANC: AUEC[0-t]|Time to reach the maximum measured absolute neutrophil count (ANC)|Venous blood samples (2 mL each) were withdrawn at pre-dose and at 8, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7), 240 (Day 11), 336 (Day 15) and 504 (Day 22) following 1st and 2nd dose administration.|Table breaks participants into ADA(-) or ADA(+), totaling the overall number of participants by arm. 5 Subjects having three consecutive missing samples in elimination phase were excluded from the analysis of AUEC0-t reducing the total participants to 88 for INTP5 Dose 1, 88 for INTP5 Dose 2, 92 for Neulasta Dose 1, and 91 for Neulasta Dose 2.|||h*ng/mL||Standard Deviation|Mean
2524758|NCT04015232|Secondary|PD Endpoints for Baseline Non-adjusted ANC: T[Max]|Area under the ANC versus time curve from time zero to the last measurable concentration as calculated by linear trapezoidal method.|Venous blood samples (2 mL each) were withdrawn at pre-dose and at 8, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7), 240 (Day 11), 336 (Day 15) and 504 (Day 22) following 1st and 2nd dose administration.|Outcome Measure Data Table is breaks participants into negative-ADA or positive-ADA, totaling the overall number of participants by arm|||h||Standard Deviation|Mean
2524759|NCT04015232|Secondary|PD Endpoints for Baseline Non-adjusted ANC: E[Max]|Maximum measured absolute neutrophil count (ANC).|Venous blood samples (2 mL each) were withdrawn at pre-dose and at 8, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7), 240 (Day 11), 336 (Day 15) and 504 (Day 22) following 1st and 2nd dose administration.|Outcome Measure Data Table is breaks participants into negative-ADA or positive-ADA, totaling the overall number of participants by arm|||x10^3cells/uL||Standard Deviation|Mean
2524760|NCT04015232|Secondary|PK Endpoints: Pegfilgrastim t[1/2]|The terminal half-life calculated using the formula 0.693/(lambda-z)|Venous blood samples (4 mL each) were withdrawn at pre-dose and at 8, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7), 240 (Day 11), 336 (Day 15) and 504 (Day 22) hours following 1st and 2nd dose, administration.|All the 19 ADA confirmed positive subjects were included in the PK analysis: 10 subjects from INTP5 and 9 subjects from US-Neulasta|||h||Standard Deviation|Mean
2524761|NCT04015232|Secondary|PK Endpoints: Pegfilgrastim AUC[_%Extrap_Obs]|The residual area in percentage determined by the formula, [(AUC[0-infinity]-AUC[0-t])/AUC[0-infinity]] x 100.|Venous blood samples (4 mL each) were withdrawn at pre-dose and at 8, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7), 240 (Day 11), 336 (Day 15) and 504 (Day 22) hours following 1st and 2nd dose, administration.|All the 19 ADA confirmed positive subjects were included in the PK analysis: 10 subjects from INTP5 and 9 subjects from US-Neulasta|||percentage of AUC||Standard Deviation|Mean
2524762|NCT04015232|Secondary|PK Endpoints: Pegfilgrastim R^2 Adjusted|Goodness of fit statistic for the terminal phase, adjusted for the number of points used in the estimation of λz (lambda-z). R^2 is the coefficient of determination and can range from 0 to 1, with higher values indicating greater predictability.|Venous blood samples (4 mL each) were withdrawn at pre-dose and at 8, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7), 240 (Day 11), 336 (Day 15) and 504 (Day 22) hours following 1st and 2nd dose, administration.|All the 19 ADA confirmed positive subjects were included in the PK analysis: 10 subjects from INTP5 and 9 subjects from US-Neulasta|||Coefficient of Determination||Standard Deviation|Mean
2524763|NCT04015232|Secondary|PK Endpoints: Pegfilgrastim λz (Lambda-z)|Terminal rate constant: First order rate constant associated with the terminal (log-linear) portion of the curve. This was estimated via linear regression of time vs. log concentration. This parameter was calculated by linear least squares regression analysis using last three or more nonzero plasma concentration values.|Venous blood samples (4 mL each) were withdrawn at pre-dose and at 8, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7), 240 (Day 11), 336 (Day 15) and 504 (Day 22) hours following 1st and 2nd dose, administration.|All the 19 ADA confirmed positive subjects were included in the PK analysis: 10 subjects from INTP5 and 9 subjects from US-Neulasta|||1/h||Standard Deviation|Mean
2524764|NCT04015232|Secondary|PK Endpoints: Pegfilgrastim T[Max]|The time of observing the peak concentration, calculated from the serum concentration vs. time profile of the individual subjects.|Venous blood samples (4 mL each) were withdrawn at pre-dose and at 8, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7), 240 (Day 11), 336 (Day 15) and 504 (Day 22) hours following 1st and 2nd dose, administration.|All the 19 ADA confirmed positive subjects were included in the PK analysis: 10 subjects from INTP5 and 9 subjects from US-Neulasta|||h||Standard Deviation|Mean
2524765|NCT04015232|Secondary|PK Endpoints: Pegfilgrastim AUC[0-∞]|Area under the serum concentration versus time curve from time zero to infinity. Where AUC[0-infinity]= AUC[0-t] + Ct/lambda-z, Ct is the last measurable concentration and lamda-z is the terminal rate constant. AUC[0-infinity] is the sum of measurable and extrapolated parts.|Venous blood samples (4 mL each) were withdrawn at pre-dose and at 8, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7), 240 (Day 11), 336 (Day 15) and 504 (Day 22) hours following 1st and 2nd dose, administration.|All the 19 ADA confirmed positive subjects were included in the PK analysis: 10 subjects from INTP5 and 9 subjects from US-Neulasta|||ng.h/mL||Standard Deviation|Mean
2524823|NCT03988426|Secondary|Episodes of Fever|Number of episodes of fever|Primary Treatment Period (24 Weeks) and Whole Treatment Period (up to 36 Weeks)||||episodes of fever|||Number
2524824|NCT03988426|Secondary|Rate of Hospitalizations Due to Infection|Annual Rate of Hospitalizations due to Infection|Primary Treatment Period (24 Weeks)||||hospitalizations/person-year|||Number
2524766|NCT04015232|Secondary|PK Endpoints: Pegfilgrastim AUC[0-t]|Area under the serum concentration vs. time curve, calculated by linear trapezoidal rule from measured data points from the time zero to the time of last quantified concentration.|Venous blood samples (4 mL each) were withdrawn at pre-dose and at 8, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7), 240 (Day 11), 336 (Day 15) and 504 (Day 22) hours following 1st and 2nd dose, administration.|All the 19 ADA confirmed positive subjects were included in the PK analysis: 10 subjects from INTP5 and 9 subjects from US-Neulasta|||ng.h/mL||Standard Deviation|Mean
2524767|NCT04015232|Secondary|PK Endpoints: Pegfilgrastim C[Max]|"Pharmacokinetic (PK) properties of the test and reference formulations were assessed by measuring serum Pegfilgrastim concentration.~Maximum measured serum concentration, calculated from the serum concentration vs. time profile of the individual subjects."|Venous blood samples (4 mL each) were withdrawn at pre-dose and at 8, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), 96 (Day 5), 120 (Day 6), 144 (Day 7), 240 (Day 11), 336 (Day 15) and 504 (Day 22) hours following 1st and 2nd dose, administration.|All the 19 ADA confirmed positive subjects were included in the PK analysis: 10 subjects from INTP5 and 9 subjects from US-Neulasta.|||ng/mL||Standard Deviation|Mean
2524768|NCT04015232|Primary|Immunogenicity Screening Incidence to Detect the Presence of Anti-PegG-CSF Antibodies.|"Immunogenicity (anti-drug antibody; ADA) data is presented for all subjects' samples collected and a descriptive analysis is provided for immunogenicity (ADA) data.~Percentage incidence within + 10% of the expected ADA positivity incidence of Test (6% ADA in Test is anticipated from literature) is not considered clinically significant.~Evaluation of immunogenicity is carried out in a tiered fashion:~Screening assay to assess if samples were positive or negative for anti-PegG-CSF.~Confirmatory assays for samples that were positive in the screening assay. The confirmatory assays assessed if antibodies were specific for INTP5, Neulasta, PEG and/or filgrastim.~Titer assay was performed to determine titer of the anti-PEG-GCSF antibody samples.~Neutralizing antibody (NAb) assay for those samples that were positive in the confirmatory assays to assess the neutralizing capability of the antibody to inhibit pegfilgrastim activity."|Samples (8 mL each) were withdrawn at screening, at pre-dose and at 336 (D-15, Week 2), 504 (D-22, Week 3, within 60 minutes before 2nd dose), 840 (D-36, Week 5), 1176 (D-50, Week 7), 1680 (D-71, Week 10) and 2016 (D-85, Week 12) hours after first dose.||||Participants|||Count of Participants
2524769|NCT04014062|Other Pre-specified|Immunogenicity: Presence of Anti-drug Antibodies|"Evaluation of immunogenicity is carried out in a tiered fashion:~Screening assay to assess if samples were positive or negative for anti-PegG-CSF.~Confirmatory assays for samples that were positive in the screening assay. The confirmatory assays assessed if antibodies were specific for INTP5, Neulasta, PEG and/or filgrastim.~Titer assay was performed to determine titer of the anti-PEG-GCSF antibody samples.~Neutralizing antibody (NAb) assay for those samples that were positive in the confirmatory assays to assess the neutralizing capability of the antibody to inhibit pegfilgrastim activity."|0-71 Days|Only a fraction of the population was tested for Immunogenicity. Only participants that displayed treatment related AEs with plausible immune-mediated pathology were analysed for immunogenicity. The data below represents the outcomes for the fraction of each arm that was tested.|||Participants|||Count of Participants
2524770|NCT04014062|Secondary|PD Endpoint: t[1/2] for Baseline-adjusted ANC|The terminal half-life will be calculated as 0.693/λz(lamda-z).|Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.|5 subjects having three consecutive missing samples in the elimination phase were excluded from the statistical analysis of AUC0-t and other elimination phase dependent PD parameters.|||h||Standard Deviation|Mean
2524771|NCT04014062|Secondary|PD Endpoint: λz(Lamda-z) and Baseline-adjusted ANC|"First order rate constant associated with the terminal (log-linear) portion of the curve. This is estimated via linear regression of time vs. log concentration.~This parameter will be calculated by linear least squares regression analysis using at least last three or more non-zero values."|Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.|5 subjects having three consecutive missing samples in the elimination phase were excluded from the statistical analysis of AUC0-t and other elimination phase dependent PD parameters.|||1/h||Standard Deviation|Mean
2524772|NCT04014062|Secondary|PD Endpoint: T[Max], Baseline-adjusted ANC|Time to reach the maximum measured absolute neutrophil count (ANC)|Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.||||h||Standard Deviation|Mean
2524773|NCT04014062|Secondary|PD Endpoint: AUEC[0-t], Baseline-adjusted ANC|Area under the absolute neutrophil count (ANC) versus time curve from time zero to the last measurable concentration as calculated by linear trapezoidal method.|Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.|5 subjects having three consecutive missing samples in the elimination phase were excluded from the statistical analysis of AUC0-t and other elimination phase dependent PD parameters.|||x10^3cells*h/uL||Standard Deviation|Mean
2524774|NCT04014062|Secondary|PD Endpoint: E[Max], Baseline-adjusted ANC|Maximum measured absolute neutrophil count (ANC)|Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.||||x10^3 cells/uL||Standard Deviation|Mean
2524775|NCT04014062|Secondary|PD Endpoint: T[Max] for Baseline Non-adjusted ANC|Time to reach the maximum measured absolute neutrophil count (ANC)|Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.||||h||Standard Deviation|Mean
2524825|NCT03988426|Secondary|Hospitalizations Due to Infection|Number of days spent in hospital due to infection|Primary Treatment Period (24 Weeks)||||days||Standard Deviation|Mean
2525022|NCT03901313|Primary|Maximum Observed Concentration in Plasma (Cmax) of Pexidartinib|Mean Cmax of pexidartinib is calculated for each treatment period|Baseline to 6 days postdose|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||ng/mL||Standard Deviation|Mean
2524776|NCT04014062|Secondary|PK Endpoint: Pegfilgrastim AUC[_Percent_Extrap_Obs]|The residual area in percentage determined by the formula, [(AUC[0-infinity]-AUC]0-t])/AUC0-infinity] x 100.|Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.|3 subjects having three consecutive missing samples in the elimination phase were excluded from the statistical analysis of AUC0-t and other elimination phase dependent PK parameters|||percent of AUC||Standard Deviation|Mean
2524777|NCT04014062|Secondary|PK Endpoint: Pegfilgrastim t[1/2]|The terminal half-life calculated using the formula 0.693/λz(lambda-z).|Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.||||h||Standard Deviation|Mean
2524778|NCT04014062|Secondary|PK Endpoint: Pegfilgrastim R^2 Adjusted|"Goodness of fit statistic for the terminal phase, adjusted for the number of points used in the estimation of λz.~R^2 is the coefficient of Determination and can range from 0 to 1,; with higher values indicating greater predictability."|Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.|3 subjects having three consecutive missing samples in the elimination phase were excluded from the statistical analysis of AUC0-t and other elimination phase dependent PK parameters|||Coefficient of Determination||Standard Deviation|Mean
2524779|NCT04014062|Secondary|PK Endpoint: Pegfilgrastim λz(Lambda-z)|Terminal rate constant: First order rate constant associated with the terminal (log-linear) portion of the curve. This was estimated via linear regression of time vs. log concentration. This parameter was calculated by linear least squares regression analysis using last three or more nonzero plasma concentration values.|Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.|3 subjects having three consecutive missing samples in the elimination phase were excluded from the statistical analysis of AUC0-t and other elimination phase dependent PK parameters|||1/h||Standard Deviation|Mean
2524780|NCT04014062|Secondary|PK Endpoint: Pegfilgrastim T[Max]|The time of observing the peak concentration, calculated from the serum concentration vs. time profile of the individual subjects.|Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.||||h||Standard Deviation|Mean
2524781|NCT04014062|Secondary|PK Endpoint: Pegfilgrastim AUC[0-t]|Area under the serum concentration vs. time curve, calculated by linear trapezoidal rule from measured data points from the time zero to the time of last quantified concentration.|Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.|3 subjects having three consecutive missing samples in the elimination phase were excluded from the statistical analysis of AUC0-t and other elimination phase dependent PK parameters|||ng.h/mL||Standard Deviation|Mean
2524782|NCT04014062|Primary|Pharmacodynamic (PD) Endpoints: AUEC[0-t] for Baseline Non-adjusted ANC|Area under the absolute neutrophil count (ANC) versus time curve from time zero to the last measurable concentration as calculated by linear trapezoidal method.|Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.|5 subjects having three consecutive missing samples in the elimination phase were excluded from the statistical analysis of AUC0-t and other elimination phase dependent PD parameters.|||x10^3 cells*h/uL||Standard Deviation|Mean
2524783|NCT04014062|Primary|Pharmacodynamic (PD) Endpoints: E[Max] for Baseline Non-adjusted ANC|Maximum measured absolute neutrophil count (ANC).|Samples were withdrawn 1 hour pre-dose and at 6, 12, 24 (D-2), 36, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 216 (D-10), 240 (D-11), 288 (D-13), 312 (D-14), 336 (D-15), 360 (D-16) and 504 (D-22) hours post-dose.||||x10^3 cells/uL||Standard Deviation|Mean
2524784|NCT04014062|Primary|Pharmacokinetic (PK) Endpoints: Pegfilgrastim AUC[0-infinity]|Area under the serum concentration versus time curve from time zero to infinity. Where AUC[0-infinity]= AUC[0-t] + Ct/λz(lambda-z), Ct is the last measurable concentration and λz(lambda-z) is the terminal rate constant.|Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.|3 subjects having three consecutive missing samples in the elimination phase were excluded from the statistical analysis of AUC0-t and other elimination phase dependent PK parameters|||ng.h/mL||Standard Deviation|Mean
2524785|NCT04014062|Primary|Pharmacokinetic (PK) Endpoints: Pegfilgrastim C[Max]|Maximum measured serum concentration, calculated from the serum concentration vs. time profile of the individual subjects.|Samples withdrawn at 1 hour pre-dose , at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 (D-2), 26, 30, 36, 42, 48 (D-3), 60, 72 (D-4), 96 (D-5), 120 (D-6), 144 (D-7), 168 (D-8), 192 (D-9), 240 (D-11), 288 (D-13), 336 (D-15) & 504 (D-22) hours post-dose.||||ng/mL||Standard Deviation|Mean
2524786|NCT04012970|Secondary|Control Erector Spinae Elasticity Change|Elasticity values measured before and after 30 minute control lying still. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. The device records the logarithmic decrement of the tissue by recording the dissipation of the mechanical energy of the tissue when it recovers shape after deformation. Elasticity is then inversely proportional to the decrement, so a higher decrement value equates to a higher dissipation of mechanical energy and a lower elasticity value. Recorded 3 times and mean value used for analysis.|Change in muscle elasticity immediately after the 30 minute control session (lying still).||||Logarithmic decrement||Standard Error|Mean
2524826|NCT03988426|Secondary|Annual Rate of Antibiotic Use|The number of antibiotic treatment episodes per person-year of treatment was calculated by the following formula: Total number of antibiotic treatment episodes / patient-years of Octanorm treatment|Primary Treatment Period (24 Weeks)||||treatment episodes per person-year|||Number
2524787|NCT04012970|Secondary|Intervention Erector Spinae Elasticity Change|Elasticity values measured before and after 30 minute spinal mobilisation intervention. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. The device records the logarithmic decrement of the tissue by recording the dissipation of the mechanical energy of the tissue when it recovers shape after deformation. Elasticity is then inversely proportional to the decrement, so a higher decrement value equates to a higher dissipation of mechanical energy and a lower elasticity value. Recorded 3 times and mean value used for analysis.|Change in muscle elasticity immediately after the 30 minute spinal mobilisation intervention.||||Logarithmic decrement||Standard Error|Mean
2524788|NCT04012970|Secondary|Control Erector Spinae Tone Change|Tone values measured before and after 30 minute control lying still. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis.|Change in muscle tone immediately after the 30 minute control session (lying still).||||Hertz (Hz)||Standard Error|Mean
2524789|NCT04012970|Secondary|Intervention Erector Spinae Tone Change|Tone values measured before and after 30 minute spinal mobilisation intervention. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis.|Change in muscle tone immediately after the 30 minute spinal mobilisation intervention.||||Hertz (Hz)||Standard Error|Mean
2524790|NCT04012970|Primary|Control Erector Spinae Stiffness Change.|Stiffness values measured before and after 30 minute control lying still. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis.|Change in muscle stiffness immediately after the 30 minute control session (lying still).||||Newton metres (Nm)||Standard Error|Mean
2524791|NCT04012970|Primary|Intervention Erector Spinae Stiffness Change|Stiffness values measured before and after 30 minute spinal mobilisation intervention. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis.|Change in muscle stiffness immediately after the 30 minute spinal mobilisation intervention.||||Newton metres (Nm)||Standard Error|Mean
2524792|NCT04002648|Primary|Severe MR|The cumulative incidence function (CIF) of recurrent mitral regurgitation (MR) >_ 3+, with death as the competing risk|12 years||||percentage of severe MR||95% Confidence Interval|Number
2524793|NCT04002648|Primary|Cardiac Death|The cumulative incidence function (CIF) of cardiac death at 12 years, with noncardiac death as a competing risk|12 years||||percentage of cardiac deaths||95% Confidence Interval|Number
2524794|NCT04000815|Secondary|Correlation Between Serum CNP and Estradiol Levels in Groups 1 and 2|Correlation of CNP vs. Estradiol levels in reproductive age and perimenopausal women|Second or Third Day of Menstruation|Estradiol should be evaluated during menstruation time period ( day 3). In postmenopausal women there is no spesific date to evaluate this hormone since they do not have menstruation. Therefore in postmenopausal arm group this hormone is not studied.|||pg/mL||Inter-Quartile Range|Median
2524795|NCT04000815|Secondary|Correlation Between Serum CNP and Antral Follicle Count (AFC) in Groups 1 and 2|Correlation between serum CNP and antral follicle count (AFC) in groups 1 and 2 using Spearman test|Second or Third Day of Menstruation|AFC should be evaluated during menstruation time period ( day 3). In postmenopausal women there is no spesific date to evaluate AFC value since they do not have menstruation. Therefore in postmenopausal arm group AFC value is not studied.|||follicles||Standard Deviation|Mean
2524796|NCT04000815|Secondary|Correlation Between Serum CNP and Follicle Stimulating Hormone and Luteinizing Hormone Levels in Groups 1 and 2|Correlations between serum CNP vs Follicle Stimulating Hormone(FSH), CNP vs Luteinizing Hormone(LH) levels in groups 1 and 2|Second or Third Day of Menstruation|FSH and LH should be evaluated during menstruation time period ( day 3). In postmenopausal women there is no spesific date to evaluate these hormones since they do not have menstruation. Therefore in postmenopausal arm group these hormones (FSH and LH) are not studied.|||mIU/mL||Inter-Quartile Range|Median
2524797|NCT04000815|Primary|Serum C Type Natriuretic Peptide Levels|The comparison of serum levels of C type natriuretic peptide among different age groups|Second or Third Day of Menstruation||||pg/ml||Inter-Quartile Range|Median
2524798|NCT04000373|Secondary|Timed 25 Foot Walk|Change in walking speed on the Timed 25 Foot Walk between baseline, end of treatment, and end of follow-up period.|0-14 weeks||||seconds||Standard Deviation|Mean
2524799|NCT04000373|Primary|Adverse Events|".All adverse events were collected throughout the study for each participant, up to 14 weeks,"|0-14 weeks||||Participants|||Count of Participants
2524800|NCT04000373|Primary|Dropout Rate|Percentage of enrolled participants who drop out of the study before the end of the treatment period.|0-14 weeks||||Participants|||Count of Participants
2524801|NCT03992482|Other Pre-specified|Change in Corneal Staining Score as Measured by Lissamine Dye Staining|Corneal staining score as measured by Lissamine Green dye staining using National Eye Institute (NEI) grading scale. Dye was applied to each eye and a slit lamp was used to observe corneal staining. NEI scale relies on a chart that divides the cornea into 5 sections and assigns a value from 0 (absent) to 3 (severe) to each section, based on the density of punctate staining, final staining score being the sum of individual section scores with a range of 0 (minimum) -15 (maximum) points. Complete corneal staining clearance with Lissamine dye defined as a score of 0 indicating the best outcome.|Between baseline and at 8 weeks of treatment||||score on a scale|Eye|Inter-Quartile Range|Median
2524827|NCT03988426|Secondary|Number of Participants Using Antibiotics From 0 to > 20 Days|Number of patients using antibiotics during the whole treatment period (36 weeks) grouped per number of days with antibiotic usage.|Primary Treatment Period (24 Weeks)||||Participants|||Count of Participants
2524828|NCT03988426|Secondary|Time to Resolution of Infections|Since infections were reported as adverse events, the time to resolution of an infection was the time from the start date of the infection adverse event to the end date of the infection adverse event.|Primary Treatment Period (24 Weeks) and Whole Treatment Period (up to 36 Weeks)||||days|||Number
2524802|NCT03992482|Other Pre-specified|The Change in the Ocular Surface Disease Index (OSDI) Which is a Patient's Subjective Rating Scale|"Ocular Surface Disease Index (OSDI), a 12-item questionnaire, assesses symptom of ocular irritation in dry eye disease (DED) and how it affects functioning related to vision in the past week. It has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on 0 to 4 scale with 0 being none of the time and 4 being all of the time. OSDI score range from 0-100 with score 0-12 being normal, 13-22 being mild DED, 23-32 being moderate DED, and >33 being severe DED. OSDI=[(sum of scores for questions answered)×100]/[(total questions answered)×4]"|Between baseline and at 8 weeks of treatment||||score on a scale||Inter-Quartile Range|Median
2524803|NCT03992482|Primary|Tolerability: The Primary Tolerability Endpoint is the Test Substance Tolerance (Visual Analog Scale) at 8 Weeks (56 Days)|"Subjects will assess their tolerance to the administration of the test medication (placebo/ study drug), utilizing a Visual Analog Scale (VAS). The VAS is a 100 mm horizontal line with verbal descriptors at either end. Subjects will place a single slash mark across the horizontal line between the end labeled completely intolerable (0 mm) and easily tolerable (100mm). The VAS ratings will be completed after administration of the test medication on Day 1 (post-dose), week 4 and week 8."|8 Weeks||||score on a scale||Inter-Quartile Range|Median
2524804|NCT03991715|Primary|Average Physical Activity Per Day (Maintenance Period)|"Average very active minutes per day of physical activity measured by the activity tracker"|Maintenance (day following when the last weekly report was sent to last day of tracking by staff), an overall total of up to 15 weeks|One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).|||minutes per day||Full Range|Mean
2524805|NCT03991715|Primary|Average Steps Per Day (Maintenance Period)|Average steps per day measured by the activity tracker|Maintenance (day following when the last weekly report was sent to last day of tracking by staff), a total of up to 15 weeks|One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).|||steps per day||Full Range|Mean
2524806|NCT03991715|Primary|Average Physical Activity in Minutes Per Day (Intervention Period)|"Average very active minutes per day of physical activity measured by the activity tracker"|Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks|One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).|||minutes per day||Full Range|Mean
2524807|NCT03991715|Primary|Average Steps Per Day (Intervention Period)|Average steps per day measured by the activity tracker|Intervention (day following cardiac rehab discharge to the day the last weekly report was sent), a total of up to 10 weeks|One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).|||steps per day||Full Range|Mean
2524808|NCT03991715|Primary|Average Physical Activity in Minutes Per Day (Preintervention Period)|"Average very active minutes per day of physical activity measured by the activity tracker"|pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks|One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).|||minutes per day||Full Range|Mean
2524809|NCT03991715|Primary|Average Steps Per Day (Preintervention Period)|Average steps per day measured by the activity tracker|pre-intervention (during cardiac rehab starting on the day the tracker was given to cardiac rehab discharge), a total of up to 10 weeks|One participant did not return to cardiac rehabilitation after the enrollment visit (after receiving activity tracker).|||steps per day||Full Range|Mean
2524810|NCT03989570|Secondary|Incidence of Any Adverse Events|adverse events related to technique or drugs|5 days||||participants|||Number
2524811|NCT03989570|Primary|Postoperative Total Fentanyl Requirement|The total amount of postoperative fentanyl in milligram was given to the patient as rescue analgesia during 24 hours|24 hours||||Milligram||Standard Deviation|Mean
2524812|NCT03989570|Primary|Time of First Post Operative Analgesic Request|the pain will be assisted based on the time for the first dose of rescue analgesia|24 hours||||Hour||Standard Deviation|Mean
2524813|NCT03988426|Secondary|Annual Rate of Infections|The annual rate of all infections of any kind of seriousness|Up to 36 weeks||||infections/person-year|||Number
2524814|NCT03988426|Secondary|Number of Infusions With Infusion Site Reaction|Total number of infusions that triggered an infusion site reaction and number of infusions that triggered mild, moderate, severe or no infusion site reactions.|Up to 36 weeks||||infusions|||Number
2524815|NCT03988426|Secondary|Number of Related Adverse Events|A related adverse event is an AE for which a causal relationship between the IMP and the AE cannot be ruled out.|Up to 36 weeks||||related adverse events|||Number
2524816|NCT03988426|Secondary|Total Number of Adverse Events Regardless of Causality|An AE is any untoward medical occurrence in a study patient receiving an IMP and which does not necessarily have a causal relationship with this treatment.|Up to 36 weeks||||adverse events|||Number
2524817|NCT03988426|Secondary|Proportion of Infusions With at Least 1 Temporally Associated AE|The proportion of infusions with at least 1 temporally associated AE (TAAE) was calculated by dividing the total number of TAAE by the total number of infusions.|Up to 36 weeks||||proportion of infusions|||Number
2524818|NCT03988426|Secondary|Number of Participants Experiencing Treatment-Emergent AEs|TEAEs were classified as temporally associated if the onset was during the infusion or within 72 hours after the end of the infusion.|Up to 36 weeks||||patients|||Number
2524819|NCT03988426|Secondary|Trough Levels of Serum Total IgG|Total IgG trough concentrations were measured in serum samples taken before each infusion given at the study site.|At baseline and at last infusion (week 33)||||g/L||Standard Deviation|Mean
2524820|NCT03988426|Secondary|Changes in the Subscales of the Form-36 Health Survey Scores From Baseline to the End of the Study|The SF-36-HS consists of 36 items organized into 8 subscales. The 8 subscales could be combined into 2 summary scores, physical and mental. The calculated summary scores were transformed to a range of 0-100, where a higher score indicates better health. A positive change score indicates improvement.|Baseline to the end of study (up to 36 weeks)||||score on a scale||Standard Deviation|Mean
2524821|NCT03988426|Secondary|Patients With Days Missed From Work/Study Due to Infections and Treatment|Total number of patients who missed days from work or study due to infections or treatment thereof.|Primary Treatment Period (24 Weeks)||||Participants|||Count of Participants
2524829|NCT03988426|Secondary|Number of Other Infections|For other infections, the Medical Dictionary for Regulatory Activities (MedDRA) preferred term was used to determine the type of infection. They were grouped into the following categories as determined by a medical expert: Ear infections, eye infections, infections of the gastrointestinal tract, infections of the genitourinary tract, upper respiratory tract infections, lower respiratory tract infections, infections of the skin, and infections not elsewhere classified.|Primary Treatment Period (24 Weeks)||||Infections|||Number
2524830|NCT03988426|Secondary|Number of Patients With Other Infections|The number of patients with all infections of any kind or seriousness.|Primary Treatment Period (24 Weeks)||||Participants|||Count of Participants
2524831|NCT03988426|Primary|Number of Serious Bacterial Infections Per Person-Year on Treatment|Serious Bacterial Infections defined as bacteraemia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess|Primary Treatment Period (24 Weeks)||||SBI per patient year|||Number
2524832|NCT03982433|Secondary|Goal Systems Assessment Battery-Alcohol|Ratings self-regulatory capacities related to moderating alcohol use. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes.|past 30 days||||units on a scale||Standard Deviation|Median
2524833|NCT03982433|Secondary|Goal Systems Assessment Battery-Pain|Ratings self-regulatory capacities related to pain. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes.|past 30 days||||score on a scale||Standard Deviation|Median
2524834|NCT03982433|Primary|Perceptions of Treatment Questionnaire|Participants were asked about their experiences with different facets of the intervention using items that were scored from 0 - 8 with higher scores reflecting greater satisfaction with the treatment components.|past 30 days||||units on a scale||Standard Deviation|Mean
2524835|NCT03982433|Primary|Client Satisfaction Questionnaire-8 [Modified]|"Evaluative ratings of the intervention received. Eight Likert-scale items regarding different components of treatment satisfaction are rated from 1-4. Some items are reversed scored and then they are summed so that higher scores reflect higher satisfaction with treatment.~The possible range of scores is 8-32."|past 30 days||||units on a scale||Standard Deviation|Mean
2524836|NCT03982433|Primary|Alcohol Time Line Follow Back...Average Drinks Per Week|average number of drinks per week in the past 30 days (total number of drinks 30 days/4.28)|past 30 days||||drinks/week||Standard Deviation|Median
2524837|NCT03982433|Primary|Alcohol Time Line Follow Back...Heavy Drinking Episodes|number of heavy drinking episodes in the past 30 days|past 30 days||||number of episodes||Standard Deviation|Median
2524838|NCT03982433|Primary|Brief Pain Inventory Pain Interference|"BPI consists of 11-point scale items that reflect pain severity and pain interference~Pain interference is measured as the mean of 7-items, each rated on a 11-point scale where 0 is best and 10 is worst Scales range from 0 - 10"|past 7 days||||units on a scale||Standard Deviation|Median
2524839|NCT03982433|Primary|Brief Pain Inventory Pain Severity|"BPI consists of 11-point scale items that reflect pain severity and pain interference Average pain severity in the past 7-days is measures with a single 11-point scale where 0 is best and 10 is worst.~Pain interference is measures as the mean of 7-items, each also rated on a 11-point scale where 0 is best and 10 is worst Scales range from 0 - 10"|past 7 days||||units on a scale||Standard Deviation|Median
2524840|NCT03975790|Secondary|Mean Total RA Related Monthly Health Care Cost|Mean total monthly health care cost due to RA is reported. RA related refers to cost spent by participants due to RA on health care services. This is calculated as the total of treatment cost (cost of tofacitinib, biologic DMARDs, NB-DMARDs and administration of IV biologics) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost, home health care cost, urgent care cost and other medical services cost). RA related monthly health care cost is reported for every month from 12 months duration before index date (pre-index period) to 12 months duration post index date (post index period). Index date is defined as the date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.|During pre-index period (at1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months before index date) and post index period (at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 month after index date)|Analysis was performed on all participants included in the study.|||dollars||Standard Deviation|Mean
2524841|NCT03975790|Secondary|Mean Total All Cause Monthly Health Care Cost|Mean total monthly health care cost due to all cause is reported. All cause refers to cost spent due to all comorbidities, including RA and calculated as the total of pharmacy cost (cost of home healthcare cost, urgent care cost and other medical services costs) and medical cost (cost of ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). Total all cause monthly health care cost is reported for every month from 12 months duration before index date (pre-index period) to 12 months duration post index date (post index period). Index date is defined as the date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.|During pre-index period (at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months before index date) and post index period (at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 month post index date)|Analysis was performed on all participants included in the study.|||dollars||Standard Deviation|Mean
2524842|NCT03975790|Primary|Mean Treatment Persistence Duration Measured for Index Medication (Tofacitinib)|Treatment persistence with tofacitinib was defined as not having a gap in therapy of at least 60 days between prescription re-fills of tofacitinib.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||days||Standard Deviation|Mean
2524938|NCT03961295|Primary|AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC||Day 1 pre-dose and at multiple time points (up to Day 127) post-dose|The PK set included all participants who received study drug and had at least 1 measurable serum concentration.|||mcg*day/mL||Geometric Coefficient of Variation|Geometric Mean
2524843|NCT03975790|Primary|Mean Total Health Care Cost RA Related During Post-Index Period|RA related healthcare cost refers to cost spent due to RA alone and was calculated as the total of treatment cost (cost of tofacitinib, biologic DMARDs, NB-DMARDs and administration of IV biologics) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost, home health care cost, urgent care cost and other medical services cost).|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||dollars||Standard Deviation|Mean
2524844|NCT03975790|Primary|Mean Total Health Care Cost Due to All Cause During Post-Index Period|Mean total health care cost due to all cause during post-index period is reported. All cause refers to cost spent due to all comorbidities, including RA and calculated as the total of pharmacy cost (cost of home healthcare cost, urgent care cost and other medical services costs) and medical cost (cost of ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||dollars||Standard Deviation|Mean
2524845|NCT03975790|Primary|Mean Total Health Care Cost RA Related During Pre-Index Period|RA related healthcare cost refers to cost spent due to RA alone and was calculated as the total of treatment cost (cost of tofacitinib, biologic DMARDs, NB-DMARDs and administration of intravenous (IV) biologics) and medical cost (cost of ambulatory cost, emergency department visits cost, inpatient admission cost, home health care cost, urgent care cost and other medical services cost).|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||dollars||Standard Deviation|Mean
2524846|NCT03975790|Primary|Mean Total Health Care Cost All Cause During Pre-Index Period|Mean total health care cost all cause during pre-index period is reported. All cause refers to cost spent due to all comorbidities including RA and calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||dollars||Standard Deviation|Mean
2524847|NCT03975790|Primary|Number of Participants With RA Related Inpatient Admissions During Post Index Period|Number of participants with at least one of an RA-related inpatient admission during the post-index period is reported. RA related refers to inpatient admissions due to RA.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study|||Participants|||Count of Participants
2524848|NCT03975790|Primary|Number of Participants With RA Related Emergency Department Visits During Post Index Period|Number of participants with at least one of the RA-related emergency department visit during the post-index period is reported. RA related refers to emergency department visits due to RA.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study|||Participants|||Count of Participants
2524849|NCT03975790|Primary|Number of Participants With RA Related Ambulatory Visits During Post Index Period|Number of participants with at least one of the RA-related ambulatory visits during the post-index period is reported. RA related refers to ambulatory visits due to RA.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study|||Participants|||Count of Participants
2524850|NCT03975790|Primary|Number of Participants With All Cause Inpatient Admissions During Post-Index Period|Number of participants with at least one inpatient admissions that was due to all cause during the post-index period is reported. All cause refers to inpatient admissions due to all comorbidities, including RA.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524851|NCT03975790|Primary|Number of Participants With All Cause Emergency Department Visits During Post-Index Period|Number of participants with at least one emergency department visits that was due to all cause during the post-index period is reported. All cause refers to emergency department visits due to all comorbidities, including RA.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524852|NCT03975790|Primary|Number of Participants With All Cause Ambulatory Visits During Post-Index Period|Number of participants with at least one ambulatory visit that was due to all cause during the post-index period is reported. All cause refers to ambulatory visits due to all comorbidities, including RA.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524853|NCT03975790|Primary|Number of Participants With RA Related Inpatient Admissions During Pre-Index Period|Number of participants with at least one inpatient admissions that was due to RA during the pre-index period is reported. RA related refers to inpatient admission due to RA.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2525000|NCT03923933|Secondary|Change in Diastolic Blood Pressure||Change from Basal to day 28||||mmHg||Standard Deviation|Mean
2524854|NCT03975790|Primary|Number of Participants With RA Related Emergency Department Visits During Pre-Index Period|Number of participants with at least one emergency department visits that was due to RA during the pre-index period is reported. RA related refers to emergency department visits due to RA.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524855|NCT03975790|Primary|Number of Participants With RA Related Ambulatory Visits During Pre-Index Period|Number of participants with at least one ambulatory visit that was due to RA during the pre-index period is reported. RA related refers to ambulatory visits due to RA.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study. p-value could not be calculated for reporting groups with 100% response.|||Participants|||Count of Participants
2524856|NCT03975790|Primary|Number of Participants With All Cause Inpatient Admissions During Pre-Index Period|Number of participants with at least one inpatient admissions that was due to all cause during the pre-index period is reported. All cause refers to inpatient admission due to all comorbidities, including RA.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524857|NCT03975790|Primary|Number of Participants With All Cause Emergency Department Visits During Pre-Index Period|Number of participants with at least one emergency department visits that was due to all cause during the pre-index period is reported. All cause refers to emergency visits due to all comorbidities, including RA.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524858|NCT03975790|Primary|Number of Participants With All Cause Ambulatory Visits During Pre-Index Period|Number of participants with at least one ambulatory visit that was due to all cause during the pre-index period is reported. All cause refers to ambulatory visits due to all comorbidities, including RA.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524859|NCT03975790|Primary|Number of Participants Who Met Medication Effectiveness Criteria: Use of Injectable Glucocorticoids|Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. Use of Injectable glucocorticoids was defined as maximum one parenteral or intra-articular glucocorticoid joint injection use after the participant had been on biologic treatment for >3 months post index date ([index date +91 days] to [index date +359 days]).|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524860|NCT03975790|Primary|Number of Participants Who Met Medication Effectiveness Criteria: Criteria for Oral Glucocorticoids|Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. Medication effectiveness criteria for oral glucocorticoids was defined as either of the following: 1) Participants cannot receive oral glucocorticoids for > 30 days between (index date +91 days) to (index date + 359 days); 2) No increase in oral glucocorticoid dose during months 6-12 after index date.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524861|NCT03975790|Primary|Number of Participants Who Met Medication Effectiveness Criteria: No Addition of NB-DMARD|Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. No addition of NB-DMARD was defined as no addition of new NB-DMARD to index therapy during post-index period.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524862|NCT03975790|Primary|Number of Participants Who Met Medication Effectiveness Criteria: No Switch From Index Medication (Tofacitinib)|Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. No switch from index medication was defined as no switching from the index medication to a (different) biologic agent during post-index period.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524863|NCT03975790|Primary|Number of Participants Who Met Medication Effectiveness Criteria: No Dose Escalation for Index Medication (Tofacitinib)|Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. No dose escalation for index medication was defined as no increase in dose for index medication compared to the starting dose during post-index period.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524864|NCT03975790|Primary|Number of Participants Who Met Medication Effectiveness Criteria: Adherence to Index Medication (Tofacitinib)|Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. Adherence to index medication was defined as at least 30 days continuous supply of tofacitinib during post-index period.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524865|NCT03975790|Primary|Number of Participants Who Used Additional NB-DMARD During Post Index Period|Number of participants who used additional NB-DMARD during post index period is reported. Additional NB-DMARD use could have been leflunomide, sulfasalazine and hydroxychloroquine.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524866|NCT03975790|Primary|Mean Adherence To Methotrexate (MTX)|Mean adherence for methotrexate is reported. Adherence was calculated as the total number of days supplied for MTX during the post-index period divided by the number of days from the first claim during the post-index period to the end of the post-index period|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||ratio||Standard Deviation|Mean
2524867|NCT03975790|Primary|Mean Medication Possession Ratio (MPR) for Methotrexate (MTX)|Mean MPR for Methotrexate is reported. MPR was calculated as the total days supply of MTX between the first and including the last prescription/administration divided by the time between the first through and including last biologic prescription/administration days supply.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|"Analysis was performed on all participants included in the study. Analysis was performed on “MTX persistent” participants only and the data for this OM was not planned to be collected and analyzed for MTX Discontinued and MTX Interrupted."|||ratio||Standard Deviation|Mean
2524868|NCT03975790|Primary|Number of Participants Who Re-started Index Medication (Tofacitinib) at Any Time During Post-Index Period|Number of participants who re-started tofacitinib (after considered as non-persistence with the tofacitinib) after discontinuation at any time during post-index period is reported.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study. Here, “overall number of participants analyzed” signifies the participants evaluable for this outcome measure.|||Participants|||Count of Participants
2524869|NCT03975790|Primary|Number of Participants Who Switched From Index Medication (Tofacitinib) at Any Time During Post-Index Period|Number of participants who switched from index medication (tofacitinib) to a biologic at any time during post-index period is reported.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524870|NCT03975790|Primary|Number of Participants With Post-Persistence Treatment Patterns|Number of participants with post-persistence treatment patterns is reported. Post-persistence was categorized as: 1) switch immediately (if participants initiated a non-index biologic before a 60-day gap in treatment is observed for the index medication); 2) discontinue then restart (if there was a gap in the index therapy of at least 60 days and the first medication observed after the gap is the index medication); 3) discontinue then switch ( if there was a gap in the index therapy of at least 60 days and the first medication observed after the gap is a biologic [including Tofacitinib] different from index medication), 4) discontinue without switch or restart (if participant's had a gap in therapy of at least 60 days and there are no claims for either the index medication or a different biologic for the remaining observation period).|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524871|NCT03975790|Primary|Number of Participants With Non-persistence to Index Medication (Tofacitinib)|Non-persistence was defined as the gap of at least 60 days in treatment with the index medication (tofacitinib) or switching to other biologic.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524872|NCT03975790|Primary|Number of Participants With Comorbidities of Interest During Pre-Index Period|Number of participants with at least one of comorbidity of interest during pre-index period is reported. The comorbidities of interest included cardiovascular diseases, chronic obstructive pulmonary disorder (COPD), asthma, kidney disease, diabetes, depression, anxiety, liver disease, sleep disorders. A participant could have >1 comorbidity of interest.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524882|NCT03975790|Primary|Number of Participants Who Used NSAIDs During Tofacitinib Persistency and Post-Persistency|Number of participants who used NSAIDs during tofacitinib persistency and post-persistency are reported. Persistence for participants is defined as the period of treatment with tofacitinib. Post persistence refers to switching to another medication from tofacitinib; or discontinuing tofacitinib either permanently or for a gap in time >60 days before restarting.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2525001|NCT03923933|Secondary|Change in Systolic Blood Pressure||Change from Basal to day 28||||mmHg||Standard Deviation|Mean
2524873|NCT03975790|Primary|Mean Out of Pocket Health Care Costs for Healthcare Services During Variable Length Pre-Index Period|Mean out of pocket health care costs for healthcare services during variable length pre-index period is reported. It is categorized as: All causes and RA related. All cause consisted of money spent by participants on all health care services (pharmacy, medical [ambulatory, emergency department and inpatient admission]). RA related signifies one spent by participants on health care services for RA. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.|During variable length pre-index period (1 year before the index date up to 5.2 years)|Analysis was performed on all participants included in the study.|||dollars||Standard Deviation|Mean
2524874|NCT03975790|Primary|Mean Out of Pocket Health Care Costs for Healthcare Services During Pre-Index Period|Mean out of pocket health care costs for healthcare services during pre-index period is reported. It is categorized as: All causes and RA related. All cause consisted of money spent by participants on all health care services (pharmacy, medical [ambulatory, emergency department and inpatient admission]). RA related signifies money spent by participants on health care services for RA.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||dollars||Standard Deviation|Mean
2524875|NCT03975790|Primary|Mean Disease Duration|Mean Disease Duration of RA based upon the variable length pre-index period is reported. Disease duration (in days) defined as the number of days from the earliest claim with a diagnosis of RA in the variable length pre-index period until the index date. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.|During variable length pre-index period (1 year before the index date up to 5.2 years)|Analysis was performed on all participants included in the study.|||days||Standard Deviation|Mean
2524876|NCT03975790|Primary|Mean Number of Visits to Rheumatologist During Variable-Length Pre-Index Period|Mean number of visits to rheumatologist during the variable-length pre-index period is reported. A visit is referring to out-patient visit specifically to a rheumatologist. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.|During variable length pre-index period (1 year before the index date up to 5.2 years)|Analysis was performed on all participants included in the study. Here, “overall number of participants analyzed” signifies the participants evaluable for this outcome measure.|||visits||Standard Deviation|Mean
2524877|NCT03975790|Primary|Mean Number of Visits to Rheumatologist During Pre-Index Period|Mean number of visits to a rheumatologist during pre-index period is reported. A visit is referring to out-patient visit specifically to a rheumatologist.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study. Here, “overall number of participants analyzed” signifies the participants evaluable for this outcome measure.|||visits||Standard Deviation|Mean
2524878|NCT03975790|Primary|Mean Total Dose of Oral Corticosteroid During Post-Index Period|Mean total dose of oral corticosteroids during post-index period is reported. The total dose is expressed as a prednisone-equivalent dose of the oral corticosteroids used.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study. Here, “overall number of participants analyzed” signifies the participants evaluable for this outcome measure.|||mg||Standard Deviation|Mean
2524879|NCT03975790|Primary|Mean Total Dose of Oral Corticosteroids During Pre-Index Period|Mean total dose of oral corticosteroids during pre-index period is reported. The total dose is expressed as a prednisone-equivalent dose of the oral corticosteroids used.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study. Here, “overall number of participants analyzed” signifies the participants evaluable for this outcome measure.|||milligram(mg)||Standard Deviation|Mean
2524880|NCT03975790|Primary|Number of Participants Who Used Oral Corticosteroids During Post-Index Period|The number of participants who used at least one oral corticosteroid during the post-index period is reported.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524881|NCT03975790|Primary|Number of Participants Who Used Oral Corticosteroids During Pre-Index Period|The number of participants who used at least one oral corticosteroid during the pre-index period is reported.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524919|NCT03965403|Other Pre-specified|Changes From Baseline in Wolf Motor Function Test Scores (FAS Subcale)|"Assessment of upper-extremity function with the Functional ability subscale of the Wolf Motor Function Test.~The average of the 15 items is reported. Scores ranges from 0 to 5, they rate the quality of the movement performance. 0= do not attempt, up to 5= identical to contralateral side. Higher scores are associated with better movement quality."|6 weeks||||score on a scale||Standard Deviation|Mean
2527546|NCT03563313|Secondary|HbA1c at 26 Weeks|Hemoglobin A1c measured at 26 weeks|26 weeks||||percentage||Standard Deviation|Mean
2524883|NCT03975790|Primary|Number of Participants Who Used Opioids During Tofacitinib Persistency and Post-Persistency|Number of participants who used opioids during tofacitinib persistency and post-persistency are reported. Persistence for participants is defined as the period of treatment with tofacitinib. Post persistence refers to switching to another medication from tofacitinib; or discontinuing tofacitinib either permanently or for a gap in time >60 days before restarting.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524884|NCT03975790|Primary|Mean Number of Days From The Index Date to The First NSAIDs Claim During Post Index Period|Mean number of days from the index date to the first NSAIDs claim during post index period are reported.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study. Here, “overall number of participants analyzed” signifies the participants evaluable for this outcome measure.|||days||Standard Deviation|Mean
2524885|NCT03975790|Primary|Mean Number of Days From The Index Date to The First Opioid Claim During Post Index Period|Mean number of days from the index date to the first opioid claim during post index period are reported.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study. Here, “overall number of participants analyzed” signifies the participants evaluable for this outcome measure.|||days||Standard Deviation|Mean
2524886|NCT03975790|Primary|Mean Number of Pharmacy Claims for Non-Steroidal Anti Inflammatory Drugs (NSAIDs) During Post-Index Period|The mean number of pharmacy claims for NSAIDs during the post-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing NSAIDs from their pharmacy.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study. Here, “overall number of participants analyzed” signifies the participants evaluable for this outcome measure.|||pharmacy claims||Standard Deviation|Mean
2524887|NCT03975790|Primary|Mean Number of Pharmacy Claims for Opioids During Post-Index Period|The mean number of pharmacy claims for opioids during the post-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing opioids from their pharmacy.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study. Here, “overall number of participants analyzed” signifies the participants evaluable for this outcome measure.|||pharmacy claims||Standard Deviation|Mean
2524888|NCT03975790|Primary|Mean Number of Pharmacy Claims for Non-Steroidal Anti Inflammatory Drugs (NSAIDs) During Pre-Index Period|The mean number of pharmacy claims for NSAIDs during the pre-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing NSAIDs from their pharmacy.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study. Here, “overall number of participants analyzed” signifies the participants evaluable for this outcome measure.|||pharmacy claims||Standard Deviation|Mean
2524889|NCT03975790|Primary|Mean Number of Pharmacy Claims for Opioids During Pre-Index Period|The mean number of pharmacy claims for opioids during the pre-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing opioids from their pharmacy.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study. Here, “overall number of participants analyzed” signifies the participants evaluable for this outcome measure.|||pharmacy claims||Standard Deviation|Mean
2524890|NCT03975790|Primary|Number of Participants Who Used NSAIDs During Post-Index Period|Number of participants who used at least one NSAID during the post-index period are reported.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524891|NCT03975790|Primary|Number of Participants Who Used Opioids During Post-Index Period|Number of participants who used at least one opioid during the post-index period are reported.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524892|NCT03975790|Primary|Number of Participants Who Used Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) During Pre-Index Period|Number of participants who used at least one NSAID during pre-index period are reported.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524893|NCT03975790|Primary|Number of Participants Who Used Opioids During Pre-Index Period|Number of participants who used at least one opioid during pre-index period are reported.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524920|NCT03965403|Other Pre-specified|Changes From Baseline in Manual Muscle Testing Scale Scores|Assessment of arm muscle strength using the manual muscle testing scale ranking from 0 (no contraction) to 10 (maximal strength). Higher scores indicate better outcomes.|6 weeks|One study participant did not completed this evaluation|||score on a scale||Standard Deviation|Mean
2524894|NCT03975790|Primary|Number of Participants With 26 Most Common Medications Use During Post-Index Period|Number of participants with 26 most common medications use during the post-index period are reported. The 26 most common medications: 1) MTX sodium, 2) folic acid, 3) prednisone, 4) acetaminophen/hydrocodone bitartrate, 5) azithromycin, 6) adalimumab, 7) hydroxychloroquine sulfate, 8) etanercept, 9) levothyroxine sodium, 10) methylprednisolone, 11) omeprazole, 12) tramadol hydrochloride, 13) meloxicam, 14) amoxicillin, 15) albuterol sulfate, 16) gabapentin, 17) acetaminophen/oxycodone hydrochloride, 18) amoxicillin/clavulanate potassium, 19) cyclobenzaprine hydrochloride, 20) fluticasone propionate, 21) ciprofloxacin hydrochloride, 22) duloxetine hydrochloride, 23) diclofenac Sodium, 24) levofloxacin, 25) cephalexin, 26) ibuprofen. A participant could have received >=1 most common medication.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study. p-value could not be calculated between reporting groups for specified rows with 100% response.|||Participants|||Count of Participants
2524895|NCT03975790|Primary|Number of Participants With 25 Most Common Medications Use During Pre-Index Period|Number of participants with 25 most common medications use during the pre-index period are reported. The 25 most medications: 1) MTX sodium, 2) folic acid, 3) prednisone, 4) acetaminophen/hydrocodone bitartrate, 5) azithromycin, 6) adalimumab, 7) hydroxychloroquine sulfate, 8) etanercept, 9) levothyroxine sodium, 10) methylprednisolone, 11) omeprazole, 12) tramadol hydrochloride, 13) meloxicam, 14) amoxicillin, 15) albuterol sulfate, 16) gabapentin, 17) acetaminophen/oxycodone hydrochloride, 18) amoxicillin/clavulanate potassium, 19) cyclobenzaprine hydrochloride, 20) fluticasone propionate, 21) ciprofloxacin hydrochloride, 22) duloxetine hydrochloride, 23) atorvastatin calcium, 24) diclofenac sodium, 25) levofloxacin. A participant could have received >=1 most common medication.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524896|NCT03975790|Primary|Mean Claims Based Index of RA Severity (CIRAS) Score During Pre-Index Period|The mean of the CIRAS score during pre-index period is reported. The CIRAS is based on claims at any time during the 12-month pre-index period, used to measure RA disease severity using 9 measures (age at index, gender, inflammatory marker test ordered, rehabilitation visit, rheumatoid factor test, Felty's syndrome, number of platelet counts ordered, number of chemistry panels ordered, rheumatologist visit). Value of all 9 measure was used to derive the overall CIRAS score which ranges from 0-7.9 with higher value indicating greater severity of RA.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||score on a scale||Standard Deviation|Mean
2524897|NCT03975790|Primary|Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period|Top 25 comorbid conditions: 1) rheumatoid arthritis/related disease, 2)other aftercare, 3)other connective tissue disease, 4)other non-traumatic joint disorders, 5)medical examination/evaluation, 6) other suspected conditions(other miscellaneous conditions other than mental disorders/infectious disease), 7)immunizations/screening for infectious disease, 8)osteoarthritis, 9)essential hypertension, 10) residual codes: unclassified, 11)disorders of lipid metabolism, 12)back problems, 13)other upper respiratory infections, 14)other lower respiratory disease, 15)other nervous system disorders, 16)other skin disorders, 17)thyroid disorders, 18)other bone disease/musculoskeletal deformities, 19) malaise/fatigue, 20)esophageal disorders, 21)nutritional deficiencies, 22)other nutritional: endocrine, metabolic disorders, 23)diabetes mellitus without complication, 24)other/unspecified benign neoplasm, 25)Other upper respiratory disease. A participant could have had >=1 comorbidity.|During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524898|NCT03975790|Primary|Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period|Top 25 comorbid conditions: 1) rheumatoid arthritis/related disease, 2)other aftercare, 3)other connective tissue disease, 4)other non-traumatic joint disorders, 5)medical examination/evaluation, 6) other suspected conditions(other miscellaneous conditions other than mental disorders/infectious disease), 7)immunizations/screening for infectious disease, 8)osteoarthritis, 9)essential hypertension, 10) residual codes: unclassified, 11)disorders of lipid metabolism, 12)back problems, 13)other upper respiratory infections, 14)other lower respiratory disease, 15)other nervous system disorders, 16)other skin disorders, 17)thyroid disorders, 18)other bone disease/musculoskeletal deformities, 19) malaise/fatigue, 20)esophageal disorders, 21)nutritional deficiencies, 22)other nutritional: endocrine, metabolic disorders, 23)diabetes mellitus without complication, 24)other/unspecified benign neoplasm, 25)genitourinary symptoms/ill-defined conditions. A participant could have had >=1 comorbidity.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study. p-value could not be calculated between reporting groups for specified rows with 100% response.|||Participants|||Count of Participants
2524899|NCT03975790|Primary|Mean Quan-Charlson Comorbidity Score of Participants|The mean Quan-Charlson Comorbidity Score during the Pre-Index Period is reported. Quan-Charlson Comorbidity Score predicts the probability of death within one year in participants and was based on the presence of any diagnosis codes on medical claims at any time during the 12-month pre-index period, based on the International Classification of Diseases (ICD) diagnosis codes. Total score ranges from 0 to 9.0. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome could result in mortality or higher healthcare resource utilization.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||score on a scale||Standard Deviation|Mean
2525002|NCT03923933|Secondary|Change in Extracellular Water / Total Body Water Ratio|Decrease in extracellular water / total body water ratio measured by bioelectrical impedance analysis|Change from Basal to day 28||||percentage of ECW/TBW||Standard Deviation|Mean
2524900|NCT03975790|Primary|Mean Number of Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Received During Variable Length Pre-Index Period|Mean number of NB-DMARD received during variable length pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.|During variable length pre-index period (1 year before the index date up to 5.2 years)|Analysis was performed on all participants included in the study. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure.|||NB-DMARD||Standard Deviation|Mean
2524901|NCT03975790|Primary|Mean Number of Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Received During Pre-Index Period|Mean number of NB-DMARD received during pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure.|||NB-DMARD||Standard Deviation|Mean
2524902|NCT03975790|Primary|Number of Participants With Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Use During Variable Length Pre-Index Period|Number of Participants with NB-MARD use during variable length pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.|During variable length pre-index period (1 year before the index date up to 5.2 years)|Analysis was performed on all participants included in the study. p-value could not be calculated for reporting groups with 100% response.|||Participants|||Count of Participants
2524903|NCT03975790|Primary|Number of Participants With Non-biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Use During Pre-Index Period|Number of Participants with NB-DMARD use during pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524904|NCT03975790|Primary|Mean Number of Biologic Disease Modifying Antirheumatic Drug (bDMARD) Received During Variable Length Pre-Index Period|Mean number of bDMARD received during variable length pre-index period is reported. The bDMARD could have been any TNFi, any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.|During variable length pre-index period (1 year before the index date up to 5.2 years)|Analysis was performed on all participants included in the study. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure.|||bDMARD||Standard Deviation|Mean
2524905|NCT03975790|Primary|Mean Number of Biologic Disease Modifying Antirheumatic Drug (bDMARD) Received During Pre-Index Period|Mean number of bDMARD received during pre-index period is reported. The bDMARD could have been any TNFi, any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|"Analysis was performed on all participants included in the study. Here, “overall number of participants analyzed signifies participants evaluable for this outcome measure."|||bDMARD||Standard Deviation|Mean
2524906|NCT03975790|Primary|Number of Participants With Biologic Disease Modifying Antirheumatic Drug (bDMARD) Use During Variable Length Pre-Index Period|Number of Participants with use of at least one bDMARD during variable length pre-index period is reported. The bDMARD could have been any TNFi, any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant, could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.|During variable length pre-index period (1 year before the index date up to 5.2 years)|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524921|NCT03965403|Other Pre-specified|Changes From Baseline in Articulations Range of Motion|Assessment of active arm range of motion with goniometry. Results are reported in degrees and higher ranges include better outcomes.|6 weeks|One study participant did not complete this evaluation|||degrees||Standard Deviation|Mean
2525003|NCT03923933|Secondary|Change in Extracellular Water|Decrease in extracellular water measured by bioelectrical impedance analysis|Change from Basal to day 28||||litres||Standard Deviation|Mean
2524907|NCT03975790|Primary|Number of Participants With Biologic Disease Modifying Antirheumatic Drug (bDMARD) Use During Pre-Index Period|Number of Participants with use of at least one bDMARD during pre-index period is reported. The bDMARD could have been any tumor-necrosis factor-alpha inhibitors (TNFi), any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524908|NCT03975790|Primary|Number of Participants in Each Geographic Region|Number of participants enrolled in the study per geographic region of the United States (northeast; north central; south; west; unknown) is reported.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524909|NCT03975790|Primary|Number of Participants as Per Type of Insurance Plan|Number of participants covered by type of insurance is reported. There were two types of insurance: 1) a private insurance plan, that is, one purchased by the participants, commercially available; 2) employer-provided insurance plan, that is, the participant's employer provided the insurance.|During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])|Analysis was performed on all participants included in the study.|||Participants|||Count of Participants
2524910|NCT03972813|Secondary|To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Sustained Willingness to Receive it|"Three years after the experimental component, parents will respond to the question If you had a daughter, how willing would you be to give your daughter an HPV vaccine at 12 years of age? This will be assessed on a 5-point scale from not at all willing (1) to very willing (5). The proportion of parents who select somewhat (4) or very willing (5) will be tallied as the primary outcome measure."|3 years|||||||
2524911|NCT03972813|Primary|To Determine How the Framing of the HPV Vaccination Across Several Dimensions Affects Short-term Willingness to Receive it|"Immediately after the experimental component, parents will respond to the question If you had a daughter, how willing would you be to give your daughter an HPV vaccine at 12 years of age? This will be assessed on a 5-point scale from not at all willing (1) to very willing (5). The proportion of parents who select somewhat (4) or very willing (5) will be tallied as the primary outcome measure."|same day as intervention||||Participants|||Count of Participants
2524912|NCT03966365|Other Pre-specified|Changes in Intraocular Pressure|the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg|will be evaluated at the end of the treatment, at the final visit (day 8)|the analysis was per protocol|||mmHg||Standard Deviation|Mean
2524913|NCT03966365|Secondary|Participants With Chemosis|The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.|will be evaluated at the end of the treatment, at the final visit (day 8)|the analysis was per protocol|||Participants|||Count of Participants
2524914|NCT03966365|Secondary|Participants With Conjunctival Hyperemia (CH) by Grade|Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.|will be evaluated at the end of the treatment, at the final visit (day 8)|the analysis was per protocol|||Participants|||Count of Participants
2524915|NCT03966365|Secondary|Visual Ability|"The visual capacity variable will be reported using as a unit of measure a fraction, this is taken from a visual test with the Snellen primer, it is a Nominal type variable. where the optimal vision is 20/20 or 1.0 in decimal and the worst 20/200 or 0.1 in decimal number.~For the appropriate management of the data, the result of the fraction obtained from the snellen scale is transformed to decimals, in this case subjects close to or equal to 1.0 have better visual acuity while subjects close to or equal to 0.1 have worse visual acuity.~The decimal equivalence scale is the result of the division of the fraction obtained in the Snellen chart. where 20/20 = 1.0; Do not confuse with Logmar scale where 20/20 = 0.0~Equivalences Snellen Scale = decimals: 20/200=0.1, 20/100=0.2, 20/50=0.4, 20/40=0.5, 20/30=0.66, 20/25=0.8, 20/20=1.0, etc."|will be evaluated at the end of the treatment, at the final visit (day 8)|the statistical analysis was per protocol (PP)|||Decimal score||Standard Deviation|Mean
2524916|NCT03966365|Secondary|Number of Eyes With Epithelial Defects by Grade|The epithelial defects will be evaluated by means of two stains, green lissamine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.|will be evaluated at the end of the treatment, at the final visit (day 8)|The statistical analysis was per protocol (PP)|||eyes|eyes||Number
2524917|NCT03966365|Primary|Eye Comfort Index|"It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100).The Eye comfort index contains items that focus on the discomfort associated with alterations of the ocular surface.~Values closer or equal to one hundred (100) correspond to greater discomfort, while values closer or equal to zero (0) correspond to greater comfort."|will be evaluated at the end of the treatment, at the final visit (day 8)|Analysis per protocol (PP)|||units on a scale||Standard Deviation|Mean
2524918|NCT03966365|Primary|Number of Adverse Events|primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent. it will be evaluated by the number of reported cases per group.|during the 14 days of evaluation, including the safety call (day 14)|The statistical analysis was by intention to treat (ITT)|||adverse events|||Number
2524922|NCT03965403|Other Pre-specified|Changes From Baseline in Modified Ashworth Scale Scores|"Assessment of muscle tone for upper extremity muscles. Score rank from 0 (no tone) to 4 (no movement possible). Lower scores indicates a better outcome.~Tone at the shoulder and elbow were measured"|6 weeks|One study participant did not completed this evaluation|||score on a scale||Standard Deviation|Mean
2524923|NCT03965403|Other Pre-specified|Changes From Baseline in Motor Activity Log Scores|Use of upper extremity in daily life. The self-reported amount of use is reported on a scale from 0 to 5. A score of zero is assigned when the hemiparetic side is not used during the activity of daily living, a score of 5 is assigned when the hemiparetic side is used as much as before the stroke. The 30 items of the scale are averaged. Higher scores are a sign of better use in daily life.|6 weeks|One study participant did not complete the questionnaire|||score on a scale||Standard Deviation|Mean
2524924|NCT03965403|Other Pre-specified|Changes From Baseline in Wolf Motor Function Test Scores (Time Subscale)|Assessment of upper-extremity function by the performance time of the Wolf Motor Function Test). The average of the 15 items is reported. The time ranges from 0 to 120 seconds. A decrease in performance time is associated with improved upper-extremity function.|6 weeks||||Time (seconds)||Standard Deviation|Mean
2524925|NCT03965403|Secondary|Changes From Baseline in Goal Attainment Scale Scores|"Standardized measure of goals selection and scaling to calculate the extend to which the participant's goals are met.~The Goal Attainment Scale ranges from -2 to +2. Positive scores indicates goals are better than expected, score of 0 indicates goals are met and negative scores indicates goals aren't met."|6 weeks||||score on a scale||Standard Deviation|Mean
2524926|NCT03965403|Primary|Changes From Baseline in Fugl-Meyer Upper Extremity Scores|Assessment of upper extremity impairments. Individual items of the scale are summed for a total score ranking from 0 to 66. Higher scores indicate better outcomes.|6 weeks||||score on a scale||Standard Deviation|Mean
2524927|NCT03965052|Other Pre-specified|Changes in Intraocular Pressure|the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg|will be evaluated at the end of the treatment, at the final visit (day 11)|the analysis was per protocol|||mmHg|eyes|Standard Deviation|Mean
2524928|NCT03965052|Secondary|Number of Eyes of Chemosis|The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.|will be evaluated at the end of the treatment, at the final visit (day 11)|the analysis was per protocol|||eyes|eyes||Count of Units
2524929|NCT03965052|Secondary|Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade|Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.|will be evaluated at the end of the treatment, at the final visit (day 11)|the analysis was per protocol|||eyes|eyes||Count of Units
2524930|NCT03965052|Secondary|Visual Ability|"The visual capacity variable will be reported using as a unit of measure a fraction, this is taken from a visual test with the Snellen primer, it is a Nominal type variable. where the optimal vision is 20/20 and the worst vision is 20/200, higher values represent a worst vision. The result of the Snellen chart has equivalents in an international logarithmic system called Logmar (logarithm of the minimum angle of resolution) for better understanding.~Snellen Scale: 20/200, 20/100, 20/50, 20/40, 20/30, 20/25, 20/20, 20/15, 20/12, 20/10.~Snellen / LogMAR equivalences: 20/200= 1.0, 20/100=0.7, 20/50=0.4, 20/40=0.3, 20/30=0.2, 20/25=0.1, 20/20=0.0, 20/15=0.13, 20/12=0.2, 20/10=-0.3, etc."|will be evaluated at the end of the treatment, at the final visit (day 11)|the analysis was per protocol|||LogMAR||Standard Deviation|Mean
2524931|NCT03965052|Secondary|Number of Eyes With Epithelial Defects by Grade|The epithelial defects will be evaluated by means of two stains, lissamine green and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.|will be evaluated at the end of the treatment, at the final visit (day 11)|The analysis was per protocol|||eyes|eyes||Count of Units
2524932|NCT03965052|Primary|Eye Comfort Index|It is a questionnaire designed to measure the irritation of the ocular surface with Rasch analysis to produce estimates on a linear scale of intervals (ratings: 0-100).The Eye comfort index contains items that focus on the discomfort associated with alterations of the ocular surface.(0: None discomfort, 100: high discomfort).|will be evaluated at the end of the treatment, at the final visit (day 11)|the analysis was per protocol|||score on a scale||Standard Deviation|Mean
2524933|NCT03965052|Primary|Number of Participants With Adverse Events|primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent. it will be evaluated by the number of reported cases per group.|during the 14 days of evaluation, including the safety call (day 14).|the analysis was carried out by intention to treat (ITT)|||Participants|||Count of Participants
2524934|NCT03961308|Primary|Cmax: Maximum Observed Serum Concentration for Vedolizumab SC||Day 1 pre-dose and at multiple time points (up to Day 127) post-dose|The PK set included all participants who received study drug and had at least one measurable serum concentration. The number of participants analyzed includes only those participants who had data available for this measure.|||microgram per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2524935|NCT03961308|Primary|AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC||Day 1 pre-dose and at multiple time points (up to Day 127) post-dose|The PK set included all participants who received study drug and had at least one measurable serum concentration. The number of participants analyzed includes only those participants who had data available for this measure.|||mcg*day/mL||Geometric Coefficient of Variation|Geometric Mean
2524936|NCT03961308|Primary|AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC||Day 1 pre-dose and at multiple time points (up to Day 127) post-dose|The pharmacokinetic (PK) set included all participants who received study drug and had at least one measurable serum concentration. The number of participants analyzed includes only those participants who had data available for this measure.|||microgram*day per milliliter(mcg*day/mL)||Geometric Coefficient of Variation|Geometric Mean
2524937|NCT03961295|Primary|Cmax: Maximum Observed Serum Concentration for Vedolizumab SC||Day 1 pre-dose and at multiple time points (up to Day 127) post-dose|The PK set included all participants who received study drug and had at least 1 measurable serum concentration.|||microgram per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2527547|NCT03563313|Secondary|CGM Mean Glucose|CGM-measured mean glucose|26 weeks||||mg/dL||Standard Deviation|Mean
2524939|NCT03961295|Primary|AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC||Day 1 pre-dose and at multiple time points (up to Day 127) post-dose|The pharmacokinetic (PK) set included all participants who received study drug and had at least 1 measurable serum concentration.|||microgram*day per milliliter(mcg*day/mL)||Geometric Coefficient of Variation|Geometric Mean
2524940|NCT03949621|Primary|Cmax: Maximum Observed Serum Concentration for Vedolizumab SC||Day 1 pre-dose and at multiple time points (up to Day 127) post-dose|The PK set included all participants who received study drug and had at least one measurable serum concentration.|||microgram per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2524941|NCT03949621|Primary|AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC||Day 1 pre-dose and at multiple time points (up to Day 127) post-dose|The PK set included all participants who received study drug and had at least one measurable serum concentration.|||mcg*day/mL||Geometric Coefficient of Variation|Geometric Mean
2524942|NCT03949621|Primary|AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC||Day 1 pre-dose and at multiple time points (up to Day 127) post-dose|The pharmacokinetic (PK) set included all participants who received study drug and had at least one measurable serum concentration.|||microgram*day per milliliter(mcg*day/mL)||Geometric Coefficient of Variation|Geometric Mean
2524943|NCT03948581|Primary|Cmax: Maximum Observed Serum Concentration for Vedolizumab SC||Day 1 pre-dose and at multiple time points (up to Day 127) post-dose|The PK set included all participants who received study drug and had at least one measurable serum concentration. It was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).|||microgram per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2524944|NCT03948581|Primary|AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab SC||Day 1 pre-dose and at multiple time points (up to Day 127) post-dose|The PK set: Participants who received study drug and had at least one measurable serum concentration. Number of participants analyzed includes only those participants who had data available for this measure. It was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).|||mcg*day/mL||Geometric Coefficient of Variation|Geometric Mean
2524945|NCT03948581|Primary|AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab SC||Day 1 pre-dose and at multiple time points (up to Day 127) post-dose|Pharmacokinetic (PK) set: Participants received study drug and had at least one measurable serum concentration. Number of participants analyzed includes only those participants who had data available for this measure. It was planned to collect data based on two device delivery presentations, not as per administration sites (abdomen, thigh, or arm).|||microgram*day per milliliter(mcg*day/mL)||Geometric Coefficient of Variation|Geometric Mean
2524946|NCT03946124|Primary|Measure of Physical Activity|Physical activity was measured by using accelerometer worn over the course of a week at follow up. Average daily step counts were derived from this weeklong measurement.|1 week|Patients who were present at follow up and completed accelerometer wear were included in analysis.|||steps per day||Inter-Quartile Range|Median
2524947|NCT03933618|Secondary|SEP #1-3 Cumulative - Week 24|"Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.~0-3: cumulative score from SEP questions 1, 2, and 3~Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0"|Week 24|SEP measured at the end of week 24 data not collected for pt 1,13 in ACP arm data not collected for pt 3, 15 in CAP arm data not collected for pt 22 in CPA arm data not collected for pt 11,23 PCA arm|||score on a scale|||Number
2524948|NCT03933618|Secondary|SEP #1-3 Cumulative - Week 16|"Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.~0-3: cumulative score from SEP questions 1, 2, and 3~Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0"|Week 16|"SEP measured at the end of week 16~data not collected for pt 3,15 in CAP arm data not collected for pt 5,11,23 in PCA arm"|||score on a scale|||Number
2524949|NCT03933618|Secondary|SEP #1-3 Cumulative - Week 8|"Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.~0-3: cumulative score from SEP questions 1, 2, and 3~Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0"|Week 8|"SEP measured at the end of week 8~data not collected for pt 11,17 in PCA arm data not collected for pt 13 in ACP arm data not collected for pt 15 in CAP arm data not collected for pt 22 in CPA arm"|||score on a scale|||Number
2524950|NCT03933618|Secondary|SEP #1-3 Cumulative - Screen|"Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3.~0-3: cumulative score from SEP questions 1, 2, and 3~Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0"|Baseline|"SEP measured at the initial encounter~Baseline SPEP was not measured for participants 1-24~Table included for completeness"||||||
2524951|NCT03933618|Secondary|SHBG - Week 24|Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24|Week 24|"SHBG measured at week 24~Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm"|||nmol/L|||Number
2524952|NCT03933618|Secondary|SHBG - Week 16|Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24|Week 16|"SHBG measured at week 16~Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm"|||nmol/L|||Number
2524953|NCT03933618|Secondary|SHBG - Week 8|Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24|Week 8|"SHBG measured at week 8~Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm"|||nmol/L|||Number
2524954|NCT03933618|Secondary|SHBG - Screen|Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24|Baseline|"SHBG measured at initial encounter~Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm"|||nmol/L|||Number
2524955|NCT03933618|Secondary|Estradiol - Week 24|Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5|Week 24|"Estradiol measurement at the end of Week 24~Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm"|||pg/mL|||Number
2524956|NCT03933618|Secondary|Estradiol - Week 16|Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5|Week 16|Estradiol measurement at the end of Week 16 Data was not collected for patient 2 in anastrazole-placebo-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm|||pg/mL|||Number
2524957|NCT03933618|Secondary|Estradiol - Week 8|Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5|Week 8|"Estradiol measurement at the end of Week 8~Data was not collected for patient 2 in anastrazole-placebo-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm"|||pg/mL|||Number
2524958|NCT03933618|Secondary|Estradiol - Screen|Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24|Baseline|"Estradiol measurement at initial encounter~Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm"|||pg/mL|||Number
2524959|NCT03933618|Secondary|Free Testosterone - Week 24|Measure of Free Testosterone|Week 24|FT measured at the end of Week 24 Data not collected for patient 8 in APC arm Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 18 in placebo-anastrazole-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm No data collected pt 24 in PAC arm|||ng/dl|||Number
2524960|NCT03933618|Secondary|Free Testosterone - Week 16|Measure of Free Testosterone|Week 16|"FT measured at the end of Week 16~Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 22 in clomiphene-placebo-anastrazole arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm"|||ng/dl|||Number
2524961|NCT03933618|Secondary|Free Testosterone - Week 8|Measure of Free Testosterone|Week 8|FT measured at the end of Week 8 Data was not collected for patient 8 in anastrazole-placebo-clomiphene arm Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 18 in placebo-anastrazole-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm|||ng/dl|||Number
2524962|NCT03933618|Secondary|Free Testosterone - Screen|Measure of Free Testosterone|Baseline|"FT measured at initial encounter~Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 18 in placebo-anastrazole-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm"|||ng/dl|||Number
2524963|NCT03933618|Secondary|FSH - Week 24|Lab Values for follicle stimulating hormone|Week 24|FSH measured at Week 24 Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm|||IU/L|||Number
2524964|NCT03933618|Secondary|FSH - Week 16|Lab Values for follicle stimulating hormone|Week 16|"FSH measured at Week 16~Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm"|||IU/L|||Number
2524965|NCT03933618|Secondary|FSH - Week 8|Lab Values for follicle stimulating hormone|Week 8|"FSH measured at Week 8~Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm"|||IU/L|||Number
2524966|NCT03933618|Secondary|FSH - Screen|Lab Values for follicle stimulating hormone|Baseline|"FSH measured at initial encounter~Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm"|||IU/L|||Number
2524967|NCT03933618|Secondary|LH - Week 24|Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.|Week 24|"LH measured at week 24~No data for patient 13 collected in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm"|||IU/L|||Number
2524968|NCT03933618|Secondary|LH - Week 16|Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.|Week 16|"LH measured at week 16~Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm"|||IU/L|||Number
2524969|NCT03933618|Secondary|LH - Week 8|Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.|Week 8|"LH measured at week 8~Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm"|||IU/L|||Number
2524970|NCT03933618|Secondary|LH - Screen|Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods.|Baseline|"LH measured at initial encounter~Data for pt 23 in placebo-clomiphene-anastrazole not collected"|||IU/L|||Number
2524971|NCT03933618|Secondary|EHS (Erectile Hardness Score) - Week 24|Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid|Week 24|Score 0-4 at the end of Week 24 no data was collected for patient 15 in clomiphene-anastrazole-placebo no data was collected for patient 23 in placebo-clomiphene-anastrazole|||score on a scale|||Number
2524972|NCT03933618|Secondary|EHS (Erectile Hardness Score) - Week 16|Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid|Week 16|"Score 0-4 at the end of Week 16~Data for patient 23 was not collected in placebo-clomiphene-anastrazole arm"|||score on a scale|||Number
2524973|NCT03933618|Secondary|EHS (Erectile Hardness Score) - Week 8|Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid|Week 8|Score 0-4 at the end of Week 8|||score on a scale|||Number
2524974|NCT03933618|Secondary|EHS (Erectile Hardness Score) - Screen|Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid|Baseline|Score 0-4 at the initial encounter week 0|||score on a scale|||Number
2524975|NCT03933618|Secondary|ADAM (Androgen Deficiency in the Aging Male) Score - Week 24|"Self reported quantification of hypogonadism. 10 yes or no questions.~A positive (yes) questionnaire result is defined as a yes or 1 and a negative (no) questionnaire result is defined as a no or 0 to question 1 or question 7 or any 3 other questions.~Yes (1) represents a better outcome than No (1)~In Data Entry:~Yes - 1 No - 0"|Week 24|ADAM score at the end of Week 24 No data collected pt 15 in clomiphene-anastrazole-placebo arm no data collected for pt 16 clomiphene-placebo-anastrazole arm no data collected for pt 23 placebo-clomiphene-anastrazole arm|||score on a scale|||Number
2524976|NCT03933618|Secondary|ADAM (Androgen Deficiency in the Aging Male) Score - Week 16|"Self reported quantification of hypogonadism. 10 yes or no questions.~A positive (yes) questionnaire result is defined as a yes or 1 and a negative (no) questionnaire result is defined as a no or 0 to question 1 or question 7 or any 3 other questions.~Yes (1) represents a better outcome than No (1)~In Data Entry:~Yes - 1 No - 0"|Week 16|ADAM score at the end of Week 16 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm|||score on a scale|||Number
2524977|NCT03933618|Secondary|ADAM (Androgen Deficiency in the Aging Male) Score - Week 8|"Self reported quantification of hypogonadism. 10 yes or no questions.~A positive (yes) questionnaire result is defined as a yes or 1 and a negative (no) questionnaire result is defined as a no or 0 to question 1 or question 7 or any 3 other questions.~Yes (1) represents a better outcome than No (1)~In Data Entry:~Yes - 1 No - 0"|Week 8|"ADAM score at the end of Week 8~Data was not collected for patient 19 in anastrazole-clomiphene-placebo arm"|||score on a scale|||Number
2524978|NCT03933618|Secondary|ADAM (Androgen Deficiency in the Aging Male) Score - Screen|"Self reported quantification of hypogonadism. 10 yes or no questions.~A positive (yes) questionnaire result is defined as a yes or 1 and a negative (no) questionnaire result is defined as a no or 0 to question 1 or question 7 or any 3 other questions.~Yes (1) represents a better outcome than No (1)~In Data Entry:~Yes - 1 No - 0"|Baseline|Initial Evaluation for ADAM score - Week 0|||score on a scale|||Number
2524979|NCT03933618|Secondary|Normalized Testosterone - Week 24|Normalized at >350ng/dl|Week 24|"Normalized Testosterone measured at the end of the 24th week~Data was not collected for patient 15 clomiphene-anastrazole-placebo Data for patient 23 was not collected for placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene"|||ng/dl|||Number
2524980|NCT03933618|Secondary|Normalized Testosterone - Week 16|Normalized at >350ng/dl|Week 16|"Normalized Testosterone measured at the end of the 16th week~Data for patient 23 was not collected for placebo-clomiphene-anastrazole arm"|||ng/dl|||Number
2524981|NCT03933618|Secondary|Normalized Testosterone - Week 8|Normalized at >350ng/dl|Week 8|"Normalized Testosterone measured at the end of the first 8 week period~Data for patient 23 was not collected for placebo-clomiphene-anastrazole arm"|||ng/dl|||Number
2524982|NCT03933618|Secondary|Normalized Testosterone - Screen|Normalized at >350ng/dl|Baseline|"Normalized Testosterone measured week 0 - initial screen~Data not collected for patient 23 in placebo-clomiphene-anastrazole arm"|||ng/dl|||Number
2524983|NCT03933618|Primary|IIEF (International Index of Erectile Function) Score - Week 24|15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75|Week 24|"Total IIEF reported at the end of the final 8 week period - at week 24~Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole"|||score on a scale|||Number
2524984|NCT03933618|Primary|IIEF (International Index of Erectile Function) Score - Week 16|15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75|Week 16|"Total IIEF reported at the end of the second 8 week period - at week 16~Data for patient 23 was not collected in the placebo-clomiphene-anastrazole arm."|||score on a scale|||Number
2524985|NCT03933618|Primary|IIEF (International Index of Erectile Function) Score - Week 8|15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75|Week 8|Total IIEF reported at the end of the first 8 week period|||score on a scale|||Number
2524986|NCT03933618|Primary|IIEF (International Index of Erectile Function) Score - Screen|15 item self reported erectile function. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75|At baseline|Total IIEF reported at the initial encounter.|||score on a scale|||Number
2524987|NCT03933449|Secondary|Number of Participants Discontinuing Study Treatment Due an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE will be presented.|From first dose of study treatment through to end-of-trial analysis data cutoff date of 31-Dec-2021 (Up to approximately 5 years)||2022-12-31|12/2022||||
2524988|NCT03933449|Secondary|Number of Participants Experiencing an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced ≥1 AE will be presented.|From first dose of study treatment through end-of-trial analysis data cutoff date of 31-Dec-2021 (Up to approximately 5 years)||2022-12-31|12/2022||||
2524989|NCT03933449|Secondary|Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus|PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by central imaging vendor review per RECIST 1.1 is presented for participants with SCC of the esophagus.|From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to approximately 24 months)|The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2525004|NCT03923933|Secondary|Change in the Fractional Excretion of Sodium|Increase in the fractional excretion of sodium compared with the baseline measure|Change from Basal to day 28||||percentage of sodium excreted||Standard Deviation|Mean
2525005|NCT03923933|Primary|Change in Mean Arterial Pressure|decrease in blood pressure compared wit baseline measure (mmhg)|Change from Basal to day 28||||mmHg||Standard Deviation|Mean
2525006|NCT03923933|Primary|Change in Total Body Water|Measured by bioelectrical impedance analysis, compared to the initial measurement|Change from Basal to day 28||||litres||Standard Deviation|Mean
2525031|NCT03894449|Secondary|Change in Immunoglobulins (IgG) From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||g/dL||Standard Deviation|Mean
2527548|NCT03563313|Secondary|CGM Time Above 180|CGM-measured % above 180 mg/dL|26 weeks||||percentage||Standard Deviation|Mean
2524990|NCT03933449|Secondary|Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)|PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by central imaging vendor review per RECIST 1.1 is presented for participants with a PD-L1 CPS ≥10.|From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to approximately 24 months)|The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2524991|NCT03933449|Secondary|Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants|PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by central imaging vendor review per RECIST 1.1 in all participants is presented.|From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to approximately 24 months)|The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2524992|NCT03933449|Secondary|Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus|ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1 by central imaging vendor review. The percentage of participants with SCC of the esophagus who experienced a CR or PR is presented.|From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to approximately 24 months)|The efficacy analysis population consisted of all randomized participants with SCC of the esophagus who experienced a confirmed response (CR or PR). Participants were included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
2524993|NCT03933449|Secondary|Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)|ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1 by central imaging vendor review. The percentage of participants with a PD-L1 CPS ≥10 who experienced a CR or PR is presented.|From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to approximately 24 months)|The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10 who experienced a confirmed response (CR or PR). Participants were included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
2524994|NCT03933449|Secondary|Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants|ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1 by central imaging vendor review. The percentage of all participants who experienced a CR or PR is presented.|From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to approximately 24 months)|The efficacy analysis population consisted of all randomized participants who experienced a confirmed response (CR or PR). Participants were included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
2524995|NCT03933449|Primary|Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus|OS was defined as the time from randomization to death due to any cause. Median OS in participants with SCC of the esophagus is presented.|From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to approximately 24 months)|The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2524996|NCT03933449|Primary|Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)|OS was defined as the time from randomization to death due to any cause. Median OS in participants with a PD-L1 CPS ≥10 is presented.|From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to approximately 24 months)|The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2524997|NCT03933449|Primary|Overall Survival (OS) in All Participants|OS was defined as the time from randomization to death due to any cause. Median OS in all participants is presented.|From randomization through final analysis data cutoff date of 13-Feb-2019 (Up to approximately 24 months)|The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2524998|NCT03927950|Primary|Montgomery-Asberg's Depression Rating Scale|"Ten-item diagnostic questionnaire to measure the severity of depressive symptoms. The lowest possible score on the scale is 0 and the highest possible score is 60. The lowest possible score on the scale represents the lack of any depressive symptoms and the highest score represents the severe depressive symptoms."|the results are for a single time point (12 weeks)||||score on a scale||Standard Deviation|Mean
2524999|NCT03927950|Secondary|Hamilton Rating Scale for Depression|"17-item diagnostic questionnaire to measure the severity of depressive symptoms. The lowest possible score on the scale is 0 and the highest possible score is 52. The lowest possible score on the scale represents the lack of any depressive symptoms and the highest score represents the severe depressive symptoms."|The outcome was measured at the week 12||||score on a scale||Standard Deviation|Mean
2525007|NCT03911752|Primary|Number of Participants Who Are Satisfied With Performance in Areas of Everyday Living.|"The semi-structured interview Canadian Measure of Occupational Performance (CMOP) was used.~The client is asked to use a 10 point scale to rate their own satisfaction during the performance of activities of daily life. Satisfaction refers to the self-perception of the results derived from doing any activity of daily life.~These typically range between 1 and 10, where 1 indicates low satisfaction, respectively, while 10 indicates high satisfaction."|2 months|Interviews. Data were not collected for Partners and Relatives because they had not any consequences in their performance due to an Acquired Brain Injury.|||Participants|||Count of Participants
2525008|NCT03911752|Primary|Number of Participants With Problems in Performance in His/Her Daily Life|"The semi-structured interview Canadian Measure of Occupational Performance (CMOP) was used.~The client chooses up to five of the most important problems identified in his/her daily life, and he/she is asked to use a 10 point scale to rate their own level of performance. These typically range between 1 and 10, where 1 indicates poor performance while 10 indicates very good performance."|2 months|Interviews. Data were not collected for Partners and Relatives because they had not any consequences in their performance due to an Acquired Brain Injury.|||Participants|||Count of Participants
2525009|NCT03911752|Primary|Number of Participants That Identified Having Occupational Priorities|"The semi-structured interview Canadian Measure of Occupational Performance (CMOP) was used.~The COPM measures performance and satisfaction in self-care, productivity and leisure from the client's perspective Areas of everyday living explored during the interview include self-care, productivity or leisure and the occupational performance problems experienced in everyday living are identified.~In step two, the client is asked to rate the importance of each of the occupations to his/her life using a 10-point rating scale.~In the third step, the client chooses up to five of the most important problems identified in step two.~In step four, the client is asked to use a 10 point scale to rate their own level of performance and satisfaction with performance for each of the five problems. These typically range between 1 and 10, where 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction."|2 months|Interviews|||Participants|||Count of Participants
2525010|NCT03911752|Primary|Number of Participants Who Felt The Approach to Sexuality During Occupational Therapy is Relevant|12 semi-structured interviews Qualitative data analysis - Theoretical concept saturation and thematic analyses.|2 months|Transcription, listening and categorizing the speaking of participants from their answers to the interviews.|||Participants|||Count of Participants
2525011|NCT03905642|Secondary|Analysis of Cystic Fibrosis Questionnaire - Revised (CFQ-R) for Absolute Change in Score|A summary of absolute change from baseline in the CFQ-R scales at each on-treatment assessment between Day 14 and Day 448 is presented for all patients and by main study treatment group for the safety population. CFQ-R is a disease specific instrument designed to measure impact on overall health, daily life, perceived well-being and symptoms on a scale from 0 to 100 points. Higher values represent a more favorable outcome.|Days 14, 28, 85, 98, 112, 169, 182,196, 253, 266, 280, 337, 350, 364, 421, 434, and 448|Per Protocol population defined as all patients who completed at least 24 of the 28 days of dosing for each of the 6 cycles|||percentage %||Standard Deviation|Mean
2525012|NCT03905642|Secondary|Antipseudomonal Rescue Therapy - Time to Therapy|The time to IV and all systemic or inhaled antipseudomonal rescue therapy is presented for the overall safety population and by treatment received.|18 Months||||percentage % participants|||Number
2525013|NCT03905642|Secondary|Antipseudomonal Rescue Therapy - Duration of Therapy|The duration of IV and all systemic or inhaled antipseudomonal rescue therapy is presented for the overall safety population and by treatment received.|18 Months||||days||Standard Deviation|Mean
2525014|NCT03905642|Secondary|Absolute Change in Sputum Density|A summary of change from extension study baseline to all post-baseline time points during the treatment periods and at the end of the off-treatment periods in P aeruginosa sputum density (log10 CFU/mL) is presented for the overall safety population and by treatment received.|Baseline, Days 14, 28, 85, 98, 112, 140, 169, 182,196, 253, 266, 280, 337, 350, 364, 421, 434, and 448|Per Protocol population defined as all patients who completed at least 24 of the 28 days of dosing for each of the 6 cycles|||Log 10 CFU/mL||Standard Deviation|Mean
2525015|NCT03905642|Secondary|FEV1 % Predicted|A summary of relative change from extension study baseline time points in FEV1 % predicted is presented for the overall safety population and by treatment received.|Baseline, Days1, 14, 28, 56, 70, 85, 98, 112, 140, 154, 169, 182,196, 224, 238, 253, 266, 280, 308, 322, 337, 350, 364, 392, 406, 421, 434, 448, 476, 490, and 504|Safety population|||Percent (%) predicted||Standard Deviation|Mean
2525016|NCT03905642|Primary|Adverse Event Profile of 560 mg Once Daily Dose of Arikayce™ Administered for Six Cycles Over Eighteen Months.|Number of Participants with indicated Adverse Events in subjects receiving 560 mg once daily dose of Arikayce™ administered for 6 cycles over 18 months.|18 Months||||participants|||Number
2525017|NCT03902392|Secondary|Evaluation of Serum Biomarker Concentrations at the End of the Treatment (T1)|Serum biomarkers (IFN-γ, IL-17, IL-4, IL-10, PTX3 and NO) (pg/ml) in the same patients of both groups A and B whose received for 3 months Polyphenols (NATUR-OX) and placebo, respectively, were evaluated. To analyze serum biomarkers an ELISA method were used .|After 3 months (T1)||||pg/ml||Standard Deviation|Mean
2525018|NCT03902392|Primary|Evaluation of Serum Biomarker Concentrations at the Time of Enrollment (T0)|At the time of enrollment (T0) concentrations of serum biomarkers (pg/ml) (IFN-γ, IL-17, IL-4, IL-10, PTX3 and NO) will be evaluated in patients of which, one group (A) will assume polyphenols (NATUR-OX ) while the other group (B) will assume placebo. Of note, from each group 7 spontaneously dropouts occurred. An ELISA method will be use to analyze and to assess serum biomarker concentrations.|Baseline (T0)||||pg/ml||Standard Deviation|Mean
2525019|NCT03901313|Primary|Terminal Half-life (t1/2)|Mean t1/2 for pexidartinib is calculated for each treatment period|Baseline to 6 days postdose|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||hours||Standard Deviation|Mean
2525020|NCT03901313|Primary|Area Under the Concentration-time Curve From Time of Dosing to Last Measurable Concentration (AUClast) and to Infinity (AUCinf)|Mean AUClast and AUCinf for pexidartinib are calculated for each treatment period|Baseline to 6 days postdose|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||ng*hour/mL||Standard Deviation|Mean
2525021|NCT03901313|Primary|Time to Cmax (Tmax)|Median Tmax of pexidartinib is calculated for each treatment period|Baseline to 6 days postdose|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||hours||Full Range|Median
2525023|NCT03900299|Secondary|Cosmetic Result|"assessment of breast cosmesis after oncoplastic surgical intervention.Evaluation is based on 5 criteria, namely: breast symmetry, glandular tissue defects, nipple and areola reconstruction, scar quality and/or retraction, and the resultant breast shape.~each criteria will be evaluated either satisfactory or not,satisfactory evaluation will represent 1 point.~unsatisfactory will represent 0 point excellent result is equal or more than 4 points good result is equal to 3 points fair result is equal to 2 points bad result is equal to 1 point or less"|12months post operative|overall number of participants subjected to oncoplastic breast surgery is 59 subdivided to categories according to the oncoplastic technique used, totally 59 patients|||Participants|||Count of Participants
2525024|NCT03900299|Primary|Recurrence of the Tumor|"assessment of the occurrence of local or distant recurrence through:~monthly clinical examination of both breast and axillae~monthly liver functions tests and complete blood count~radiological assessment if clinically indicated"|12moths post operative||||Participants|||Count of Participants
2525025|NCT03899064|Primary|Within-subject Comparison of Dermal Reaction by the Overall Numeric Rating of Erythema and Edema at 5 Defined Test Sites, After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation.|"After an induction phase, where subjects were treated with MC2-01 Cream, MC2-01 vehicle and irradiation, the challenge phase was initiated.~MC2-01 Cream and MC2-01 vehicle was applied to each two naive test sites. Another two naive test sites were untreated. 24 hours of product application, one of each test site (MC2-01 Cream, MC2-01 vehicle and untreated) were irradiated. Possible changes in dermal reaction (erythema and edema) was evaluated at all 6 test sites, 24, 48 and 72 hours post-irradiation and these evaluations are the outcome measure of the study.~The following visual scores was used to express the response observed at each timepoints: Erythema: 0-3 where 0 represents no reaction and 3 represents marked/severe erythema. Edema: 0-2 where 0 represents no reaction and 2 represents definite edema with erosion/vesiculation. The diagnosis of photosensitization response will be made by the investigator based on review of the scored skin responses of both erythema and edema."|72 hours|As the study is a within subject evaluation of dermal reactions, after application on two sites with MC2-01 cream, two sites with MC2-01 vehicle and one site untreated, followed by either irradiation or non-irradiation, all subjects received all 5 different treatments.|||Participants|||Count of Participants
2525026|NCT03899064|Primary|Within-subject Comparison of Dermal Reaction by the Overall Numeric Rating of Erythema and Edema at 5 Defined Test Sites, After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation.|"After an induction phase, where subjects were treated with MC2-01 Cream, MC2-01 vehicle and irradiation, the challenge phase was initiated.~MC2-01 Cream and MC2-01 vehicle was applied to each two naive test sites. Another two naive test sites were untreated. 24 hours of product application, one of each test site (MC2-01 Cream, MC2-01 vehicle and untreated) were irradiated.~Possible changes in dermal reaction (erythema and edema) was evaluated at all 6 test sites, 24, 48 and 72 hours post-irradiation and these evaluations are the outcome measure of the study. The following visual scores was used to express the response observed at each timepoints: Erythema: 0-3 where 0 represents no reaction and 3 represents marked/severe erythema. Edema: 0-2 where 0 represents no reaction and 2 represents definite edema with erosion/vesiculation. The diagnosis of photosensitization response will be made by the investigator based on review of the scored skin responses of both erythema and edema."|48 hours|As the study is a within subject evaluation of dermal reactions, after application on two sites with MC2-01 cream, two sites with MC2-01 vehicle and one site untreated, followed by either irradiation or non-irradiation, all subjects received all 5 different treatments.|||Participants|||Count of Participants
2525027|NCT03899064|Primary|Within-subject Comparison of Dermal Reaction by the Overall Numeric Rating of Erythema and Edema at 5 Defined Test Sites, After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation.|"After an induction phase, where subjects were treated with MC2-01 Cream, MC2-01 vehicle and irradiation, the challenge phase was initiated.~MC2-01 Cream and MC2-01 vehicle was applied to each two naive test sites. Another naive test site was untreated. 24 hours after product application, one of each test site (MC2-01 Cream, MC2-01 vehicle) + the untreated site were irradiated. Possible changes in dermal reaction (erythema and edema) was evaluated at all 5 test sites 24, 48 and 72 hours post-irradiation and these evaluations are the outcome measure of the study.~The following visual scores was used to express the response observed at each timepoints: Erythema: 0-3 where 0 represents no reaction and 3 represents marked/severe erythema. Edema: 0-2 where 0 represents no reaction and 2 represents definite edema with erosion/vesiculation. The diagnosis of photosensitization response will be made by the investigator based on review of the scored skin responses of both erythema and edema."|24 hours|As the study is a within subject evaluation of dermal reactions, after application on two sites with MC2-01 cream, two sites with MC2-01 vehicle and one site untreated, followed by either irradiation or non-irradiation, all subjects received all 5 different treatments.|||Participants|||Count of Participants
2525028|NCT03898349|Primary|Perception of HCV Treatment Success|"The primary goal of the automated text messaging system is to improve patient self-management. As such, we measured illness perception and patient activation using a validated instrument adapted for HCV (Fisher L, Glasgow RE, Mullan JT, Skaff MM, Polonsky WH. Development of a brief diabetes distress screening instrument. Ann Fam Med 2008;6(3):246-252). The item Feeling that I am failing with my HCV treatment represents patient perceptions about their ability to take medications as prescribed and reflects concerns about failing HCV treatment."|Post (after 12 weeks of Annie text messaging use)|This was not an intent to treat design, therefore UI and AI groups were combined to compare texters and non-texters from each of the groups (and control).|||Participants|||Count of Participants
2525029|NCT03897179|Primary|RRp Arms of Sensor Accuracy|Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00032 and/or INVSENSOR00033 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00032 and/or INVSENSOR00033 RRp measurement for a number of samples. The average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms value.|1-5 hours||||respiration per minute (RPM)|||Number
2525030|NCT03894449|Secondary|Change in Immunoglobulins (IgM) From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||g/dL||Standard Deviation|Mean
2528838|NCT03479216|Secondary|Surgery Time|time from skin incision to closure|24 hours||||minutes||Full Range|Mean
2525034|NCT03894449|Secondary|Change in Renal Functions Tests (Serum Creatinine) From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||mg/dL||Standard Deviation|Mean
2525035|NCT03894449|Secondary|Change in Renal Functions Tests (Serum Urea) From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||mg/dL||Standard Deviation|Mean
2525036|NCT03894449|Secondary|Change in Liver Functions Tests (Total Bilirubin) From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||mg/dL||Standard Deviation|Mean
2525037|NCT03894449|Secondary|Change in Liver Functions Tests (ALP) From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||IU/L||Standard Deviation|Mean
2525038|NCT03894449|Secondary|Change in Liver Functions Tests (AST) From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||IU/L||Standard Deviation|Mean
2525039|NCT03894449|Secondary|Change in Liver Functions Tests (ALT) From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||IU/L||Standard Deviation|Mean
2525040|NCT03894449|Primary|Change in Total Iron Binding Capacity Levels From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||mcg/dL||Standard Deviation|Mean
2525041|NCT03894449|Primary|Change in Transferrin Saturation Factor Levels From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||% Transferrin||Standard Deviation|Mean
2525042|NCT03894449|Primary|Change in Serum Transferrin Levels From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||mg/dL||Standard Deviation|Mean
2525043|NCT03894449|Primary|Change in Serum Ferritin Levels From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||ng/mL||Standard Deviation|Mean
2525044|NCT03894449|Primary|Change in Serum Folate Levels From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||ng/mL||Standard Deviation|Mean
2525045|NCT03894449|Primary|Change in Serum Iron Levels From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||mcg/dL||Standard Deviation|Mean
2525046|NCT03894449|Primary|Change in Mean Corpuscular Hemoglobin Concentration From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||g/dL||Standard Deviation|Mean
2525047|NCT03894449|Primary|Change in Mean Corpuscular Hemoglobin From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||pg||Standard Deviation|Mean
2525048|NCT03894449|Primary|Change in Mean Corpuscular Volume From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||fL||Standard Deviation|Mean
2525049|NCT03894449|Primary|Change in Hematocrit in Concentration From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||% of RBCs in blood||Standard Deviation|Mean
2525050|NCT03894449|Primary|Change in Hemoglobin Concentration From Baseline to 90 Days||Baseline, 30 days, 60 days, 90 days||||g/dL||Standard Deviation|Mean
2525051|NCT03892564|Primary|Within-subject Comparison and Evaluator Rating of Possible Dermal Reactions (Erythema, Edema and Other Signs of Cutaneous Irritation), After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation|MC2-01 Cream, MC2-01 vehicle will be applied each to two sites. One further site will function as control site and will remain untreated. 24 hours after product application, the test sites, including the untreated control site will be evaluated for cutaneous reaction. One set of MC2-01 and MC2-01 vehicle + the untreated control site will be designated for irradiation and the other set will remain non-irradiated. Possible changes in dermal reactions (erythema, edema and other signs of cutaneous irritation) at the 5 test sites, 24 and 48 hours post-irradiation is the outcome measure of the study|48h post-irradiation|As the study is a within subject evaluation of dermal reactions, after application on two sites with MC2-01 cream and two sites with MC2-01 vehicle, followed by either irradiation or non-irradiation + a irradiated control site, all subjects received all 5 different treatments.|||Participants|||Count of Participants
2525052|NCT03892564|Primary|Within-subject Comparison and Evaluator Rating of Possible Dermal Reactions (Erythema, Edema and Other Signs of Cutaneous Irritation), After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation|MC2-01 Cream, MC2-01 vehicle will be applied each to two sites. One further site will function as control site and will remain untreated. 24 hours after product application, the test sites, including the untreated control site will be evaluated for cutaneous reaction. One set of MC2-01 and MC2-01 vehicle + the untreated control site will be designated for irradiation and the other set will remain non-irradiated. Possible changes in dermal reactions (erythema, edema and other signs of cutaneous irritation) at the 5 test sites, 24 and 48 hours post-irradiation is the outcome measure of the study|24h post-irradiation|As the study is a within subject evaluation of dermal reactions, after application on two sites with MC2-01 cream and two sites with MC2-01 vehicle, followed by either irradiation or non-irradiation + a irradiated control site, all subjects received all 5 different treatments.|||Participants|||Count of Participants
2525053|NCT03892564|Primary|Within-subject Comparison and Evaluator Rating of Possible Dermal Reactions (Erythema, Edema and Other Signs of Cutaneous Irritation), After Application of MC2-01 Cream, MC2-01 Vehicle or Untreated at Defined Test Sites, Followed by Irradiation|MC2-01 Cream, MC2-01 vehicle will be applied each to two sites. One further site will function as control site and will remain untreated. 24 hours after product application, the test sites, including the untreated control site will be evaluated for cutaneous reaction. One set of MC2-01 and MC2-01 vehicle + the untreated control site will be designated for irradiation and the other set will remain non-irradiated. Possible changes in dermal reactions (erythema, edema and other signs of cutaneous irritation) at the 5 test sites, 24 and 48 hours post-irradiation is the outcome measure of the study|Baseline, before irradiation|As the study is a within subject evaluation of dermal reactions, after application on two sites with MC2-01 cream and two sites with MC2-01 vehicle, followed by either irradiation or non-irradiation + a irradiated control site, all subjects received all 5 different treatments.|||Participants|||Count of Participants
2525054|NCT03888755|Secondary|Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as Adverse Event (AE)|A standard 12-lead ECG was performed. The number of participants who reported clinically significant changes in ECGs were reported.|From start of study drug administration to follow-up (up to 10 days)|The treated population included all participants treated with icatibant|||Participants|||Count of Participants
2525080|NCT03888391|Other Pre-specified|Conners Global Index - Parent Report|Parent completed dimensional rating of ADHD symptoms, with scores ranging from 0-30, and higher scores signifying more severe symptoms.|Change over baseline, Month 3, Month 6, Month 9, Month 12|||||||
2546552|NCT02919995|Secondary|FVC|Forced vital capacity (FVC) measured using spirometry|Over 24 hours after treatment|||||||
2525055|NCT03888755|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs Reported as Adverse Event (AE)|Vital signs included pulse rate, blood pressure, respiration rate, and temperature. The number of participants with clinically significant changes in vital signs were reported.|From start of study drug administration to follow-up (up to 10 days)|The treated population included all participants treated with icatibant|||Participants|||Count of Participants
2525056|NCT03888755|Secondary|Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests Reported as Adverse Event (AE)|Clinical laboratory tests included serum chemistry, hematology, urinalysis and coagulation were assessed. Number of participants with clinically significant changes in clinical laboratory tests were reported.|From start of study drug administration to follow-up (up to 10 days)|The treated population included all participants treated with icatibant|||Participants|||Count of Participants
2525057|NCT03888755|Secondary|Number of Participants With Injection Site Reactions Reported as Adverse Event (AE)|Number of participants with injection site reactions (erythema, swelling, cutaneous pain, burning sensation, itching/pruritus, and warm sensation) were reported.|From start of study drug administration to follow-up (up to 10 days)|The treated population included all participants treated with icatibant|||Participants|||Count of Participants
2525058|NCT03888755|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An AE was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurred in any phase of a clinical study, whether or not considered investigational product related. The TEAEs were defined as all AEs occurred on or after the time of study drug administration.|From start of study drug administration to follow-up (up to 10 days)|The treated population included all participants treated with icatibant|||Participants|||Count of Participants
2525059|NCT03888755|Secondary|Area Under the Concentration-time Curve From 0 to 6 Hours (AUC0-6) After a Single Subcutaneous (SC) Administration of Icatibant|The AUC0-6 was estimated by a population PK modeling approach. The AUC0-6 of Icatibant was reported.|Baseline, 0.75, 2 hours post-treatment|The PK analysis population included all participants who received study drug and provided evaluable plasma drug concentrations.|||ng•h/mL||Standard Deviation|Mean
2525060|NCT03888755|Secondary|Area Under the Concentration-time Curve From 0 to 4 Hours (AUC0-4) After a Single Subcutaneous (SC) Administration of Icatibant|The AUC0-4 was estimated by a population PK modeling approach. The AUC0-4 of Icatibant was reported.|Baseline, 0.75, 2 hours post-treatment|The PK analysis population included all participants who received study drug and provided evaluable plasma drug concentrations.|||ng•h/mL||Standard Deviation|Mean
2525061|NCT03888755|Secondary|Area Under the Concentration-time Curve From 0 to 2 Hours (AUC0-2) After a Single Subcutaneous (SC) Administration of Icatibant|The AUC0-2 was estimated by a population PK modeling approach. The AUC0-2 of Icatibant was reported.|Baseline, 0.75, 2 hours post-treatment|The PK analysis population included all participants who received study drug and provided evaluable plasma drug concentrations.|||Nanograms*hour per milliliter (ng•h/mL)||Standard Deviation|Mean
2525062|NCT03888755|Secondary|Maximum Observed Plasma Concentration (Cmax) of Icatibant After a Single Subcutaneous (SC) Administration of Icatibant|The Cmax was estimated by a population PK modeling approach. The Cmax of icatibant was reported.|Baseline, 0.75, 2 hours post-treatment|The pharmacokinetic (PK) analysis population included all participants who received study drug and provided evaluable plasma drug concentrations.|||Nano grams per milliliter (ng/mL)||Standard Deviation|Mean
2525063|NCT03888755|Secondary|Time to Almost Complete Symptom Relief As Assessed by Visual Analog Scale (VAS) Score|Time to almost complete symptom relief was calculated from the time of icatibant administration to almost complete symptom relief. Almost complete symptom relief was determined retrospectively as the earliest of three consecutive non-missing measurements for which all VAS scores < 10 mm. A VAS utilizes a scale consisting of a 100 millimeter (mm) horizontal line with extreme values at the beginning (0 mm = no symptom) and end (100 mm = worst possible symptom) of the line. The participant should draw a vertical line at the point along the scale that represents the current status of the measured symptom.|Baseline up to 120 hours post-treatment|The treated population included all participants treated with icatibant|||H||Inter-Quartile Range|Median
2525064|NCT03888755|Secondary|Time to Initial Symptom Improvement by Participants|Time to initial symptom improvement was evaluated by the participants; each were asked to record the time at which they perceived initial improvement of symptoms. Time to initial symptom improvement was calculated from the time of icatibant administration to the time reported by the participant of initial improvement of symptoms.|Baseline up to 120 hours post-treatment|The treated population included all participants treated with icatibant.|||h||95% Confidence Interval|Median
2525065|NCT03888755|Secondary|Time to Initial Symptom Improvement by Investigator|Time to initial symptom improvement was evaluated by the investigator; each were asked to record the time at which they perceived initial improvement of symptoms. Time to initial symptom improvement was calculated from the time of icatibant administration to the time reported by the investigator of initial improvement of symptoms.|Baseline up to 120 hours post-treatment|The treated population included all participants treated with icatibant|||H||95% Confidence Interval|Median
2525066|NCT03888755|Secondary|Investigator Global Assessment|"The investigator was made a global assessment (that is [i.e.] consideration of all abdominal symptoms combined, all cutaneous symptoms combined and/or all laryngeal symptoms combined) using the following 5-point scale, where the symptoms were scored from 0 for absence of symptoms to 4 for very severe: 0 = none (absence of symptoms); 1 = mild (no to mild interference with daily activities); 2 = moderate (moderate interference with daily activities); 3 = severe (severe interference with daily activities); 4 = very severe (very severe interference with daily activities)."|2, 4 and 8 hours post dose|The treated population included all participants who received one dose of icatibant.|||Score on a scale||Standard Deviation|Mean
2525081|NCT03888391|Secondary|Pulse|A dimensional measure assessed in heart beats per minute.|Change over baseline, Month 3, Month 6, Month 9, Month 12|Some participants were lost to follow up over time.|||Heart beats per minute.||Standard Error|Least Squares Mean
2525082|NCT03888391|Secondary|Diastolic Blood Pressure|A dimensional measure assessed in mm Hg.|Change over baseline, Month 3, Month 6, Month 9, Month 12|Some participants lost to follow up over time.|||mm Hg.||Standard Error|Least Squares Mean
2525136|NCT03870737|Secondary|Height|A dimensional measure assessed in cm.|Change over Baseline, Week 2, Week 4|Some participants lost to follow up.|||cm.||Standard Error|Least Squares Mean
2525067|NCT03888755|Secondary|Composite Symptom Score (SS) Assessed by Participant|The participant-assessed composite symptom score was calculated as an average of abdominal pain, nausea, vomiting, diarrhea, skin pain, erythema, skin irritation, and skin swelling (8 symptoms) for non-laryngeal attacks and the average of abdominal pain, nausea, vomiting, diarrhea, skin pain, erythema,skin irritation, skin swelling, dysphagia and voice change (10 symptoms) for laryngeal attacks using the following 5-point scale 0 = none (absence of symptoms); 1 = mild (no to mild interference with daily activities); 2 = moderate (moderate interference with daily activities); 3 = severe (severe interference with daily activities); 4 = very severe (very severe interference with daily activities). Here the composite SS assessed by participant was reported.|8 hours post dose|The treated population included all participants treated with icatibant|||Score on a scale||Standard Deviation|Mean
2525068|NCT03888755|Secondary|Composite Symptom Score (SS) Assessed by Investigator|The investigator-assessed composite symptom score was calculated as an average of abdominal tenderness, nausea, vomiting, diarrhea, skin pain, erythema, skin irritation, and skin swelling (8 symptoms) for non-laryngeal attacks and the average of abdominal tenderness, nausea, vomiting, diarrhea, skin pain, erythema, skin irritation, skin swelling, dysphagia, voice change, breathing difficulties, stridor, and asphyxia (13 symptoms) for laryngeal attacks using the following 5-point scale 0 = none (absence of symptoms); 1 = mild (no to mild interference with daily activities); 2 = moderate (moderate interference with daily activities); 3 = severe (severe interference with daily activities); 4 = very severe (very severe interference with daily activities). Here the composite SS assessed by investigator was reported.|8 hours post dose|The treated population included all participants treated with icatibant|||Score on a scale||Standard Deviation|Mean
2525069|NCT03888755|Secondary|Change From Baseline in the Composite Visual Analog Scale (VAS) Score|A VAS utilizes a scale consisting of a 100 mm horizontal line with extreme values at the beginning (0 mm = no symptom) and end (100 mm = worst possible symptom) of the line. The participant should draw a vertical line at the point along the scale that represents the current status of the measured symptom. Composite VAS scores was calculated as the average of VAS measurements for skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice change (5-symptom composite) for laryngeal attacks and as the average of VAS measurements for skin swelling, skin pain and abdominal pain (3-symptom composite) for non-laryngeal attacks. Change from baseline in the composite VAS score was reported.|Baseline, 2, 4 and 8 hours post-treatment|The treated population included all participants treated with icatibant|||Score on a scale||Standard Deviation|Mean
2525070|NCT03888755|Secondary|Time to Onset of Primary Symptom Relief (TOSR-P)|Primary symptom relief was based on the participant-assessed VAS score for a single primary symptom (determined by edema location) and corresponds to a reduction by 31 mm at a pretreatment VAS of 100 mm and by 21 mm at a pretreatment VAS of 30 mm. If the primary symptom pretreatment VAS less than (<) 30 mm, then primary symptom relief was defined as 68% reduction from pretreatment. A VAS utilizes a scale consisting of a 100 millimeter (mm) horizontal line with extreme values at the beginning (0 mm = no symptom) and end (100 mm = worst possible symptom) of the line. The TOSR-P was calculated from the time of icatibant administration to the onset of primary symptom relief.|Baseline up to 120 hours post-treatment|The treated population included all participants treated with icatibant|||Hours||95% Confidence Interval|Median
2525071|NCT03888755|Primary|Time to Onset of Symptom Relief (TOSR)|The TOSR was defined as a 50 percent (%) reduction from the pre-treatment score in the 3-symptom composite VAS score for non-laryngeal attacks and 5-symptom composite VAS score for laryngeal attacks. A VAS utilizes a scale consisting of a 100 millimeter (mm) horizontal line with extreme values at the beginning (0 mm = no symptom) and end (100 mm = worst possible symptom) of the line. The participant should draw a vertical line at the point along the scale that represents the current status of the measured symptom. Composite VAS scores were calculated as the average of VAS measurements for skin swelling, skin pain, and abdominal pain (3-symptom composite) for non-laryngeal attacks and for skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice change (5-symptom composite) for laryngeal attacks.|Baseline up to 120 hours post-treatment|The treated population included all participants treated with icatibant|||Hours||95% Confidence Interval|Median
2525072|NCT03888391|Other Pre-specified|Behavior Rating Inventory of Executive Functioning (BRIEF)|A parent completed rating of executive functioning. Comprises 5 sub scales that measure various measures of behavior and cognition. Raw scores for each measure are converted to T scores ranging from 28 to 103, with higher scores indicating greater difficulties.|Change over baseline, Month 3, Month 6, Month 9, Month 12|||||||
2525073|NCT03888391|Other Pre-specified|Children's Depression Rating Scale - Revised (CDRS-R)|A clinician completed dimensional measure of child mood symptoms, obtained from parent and child interview, with range of scores from 17 to 113, and higher scores indicating more severe depression. A score >= 40 suggests depression; scores <=28 define remission.|Change over baseline, Month 3, Month 6, Month 9, Month 12|||||||
2525074|NCT03888391|Other Pre-specified|Multidimensional Anxiety Scale for Children (MASC) Parent Report|A parent completed measure of child anxiety, with scores ranging fro 0-300, and higher scores indicating greater severity.|Change over baseline, Month 3, Month 6, Month 9, Month 12|||||||
2525075|NCT03888391|Other Pre-specified|Multidimensional Anxiety Scale for Children (MASC) Child Report|A child completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity.|Change over baseline, Month 3, Month 6, Month 9, Month 12|||||||
2525076|NCT03888391|Other Pre-specified|Children's Sleep Habits Questionnaire (CSHQ)|A parent completed 33-item scale to assess sleep related problems. Total scores range from 33 to 99, divided among 8 sub scales, with higher scores indicating more severe difficulties.|Change over baseline, Month 3, Month 6, Month 9, Month 12|||||||
2525077|NCT03888391|Other Pre-specified|Affective Reactivity Index (ARI-P) Parent|A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.|Change over baseline, Month 3, Month 6, Month 9, Month 12|||||||
2525078|NCT03888391|Other Pre-specified|Affective Reactivity Index (ARI-C) Child|A child completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.|Change over baseline, Month 3, Month 6, Month 9, Month 12|||||||
2525079|NCT03888391|Other Pre-specified|Conner Global Index - Teacher Report|Teacher completed dimensional rating of ADHD symptoms, with scores ranging from 0-30, and higher scores indicating more severe symptoms.|Change over baseline, Month 3, Month 6, Month 9, Month 12|||||||
2525083|NCT03888391|Secondary|Systolic Blood Pressure|A dimensional measure assessed in mm Hg.|Change over baseline, Month 3, Month 6, Month 9, Month 12|Some participants lost to follow up over time.|||mm Hg.||Standard Error|Least Squares Mean
2525084|NCT03888391|Secondary|Weight|A dimensional measure assessed in kg.|Change over baseline, Month 3, Month 6, Month 9, Month 12|Some participants lost to follow up over time.|||kg.||Standard Error|Least Squares Mean
2525085|NCT03888391|Secondary|Height|A dimensional measure assessed in cm.|Change over baseline, Month 3, Month 6, Month 9, Month 12|Some participants lost to follow up over time.|||cm.||Standard Error|Least Squares Mean
2525086|NCT03888391|Secondary|Clinical Global Impression - Improvement (CGI-I)|"Categorical measure indicating degree improved or not improved compared with global functioning at baseline in the preceding double-blind trial. The base CGI-I scale is a 7-point measure that requires the investigator to assess how much the condition has improved or worsened compared to baseline prior to initiation of treatment. Ratings are (1) very much improved; (2) much improved; (3) minimally improved; (4) no change; (5) minimally worse; (6) much worse; (7) very much worse. For purposes of analysis, the measure is dichotomized such that scores <= 2 signify improved and scores > 2 signify not improved."|Change over baseline, Month 3, Month 6, Month 9, Month 12|Some participants lost to follow up over time.|||Participants|||Count of Participants
2525087|NCT03888391|Primary|ADHD-IV Rating Scale (ADHD-RS)|A dimensional rating of ADHD symptoms, with scores ranging from 0 to 54, with higher scores signifying worse severity.|Change over baseline, Month 3, Month 6, Month 9, Month 12|Participants lost to follow up over time.|||score on a scale||Standard Error|Least Squares Mean
2525088|NCT03888274|Secondary|Numeric Rating Scale for Pain|Acute Change in Numeric Rating Scale for Pain from Baseline to 6 Hours. Scale range 0, no pain, to 10 severe pain.|6 hours||||score on a scale||Standard Error|Mean
2525089|NCT03888274|Secondary|Congestion Quantifier 7|Change in Congestion Quantifier 7 from Baseline to Four Weeks. Congestion Quantifier 7 is a 7 item questionnaire that quantifies congestion symptom severity. It is scored from 0 (no congestion symptoms) to 28 (severe congestions symptoms).|4 Weeks||||score on a scale||Standard Error|Mean
2525090|NCT03888274|Primary|Numeric Rating Scale for Pain|Change in Numeric Rating Scale for Pain from Baseline to Four Weeks. Scale range 0, no pain, to 10 severe pain.|4 weeks||||score on a scale||Standard Error|Mean
2525091|NCT03886701|Secondary|Adverse Event|Safety and tolerability|Days 1-24 post-dose (period 1 and 2) and 31-34 post-dose (post-study)||||participants|||Number
2525092|NCT03886701|Primary|Doravirine Oral Clearance (CL/F)|Doravirine apparent oral clearance derived from plasma sampling|Day 4 and 21 (Period 1 and 2): 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose||||L/hr||Geometric Coefficient of Variation|Geometric Mean
2525093|NCT03886701|Primary|Doravirine Area Under the Plasma Concentration Versus Time Curve From 0 to 12 Hours (AUC0-12)|Doravirine area under the plasma-concentration time curve derived from plasma sampling during one dosing interval|Day 4 and 21 (Period 1 and 2): 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose||||hr x ug/mL||95% Confidence Interval|Geometric Mean
2525094|NCT03886701|Primary|Doravirine Maximum Concentration (Cmax)|Doravirine maximum observed concentration during the dosing interval|Day 4 and 21 (Period 1 and 2): 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose||||ug/mL||95% Confidence Interval|Geometric Mean
2525095|NCT03882047|Secondary|Response to Therapy at Day 15 (Participant Evaluation)|Response to therapy was evaluated by participants and based upon their status scored at Day 15. Participants evaluated their response to therapy using the following 5-point scale: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms.|Day 15|All randomized participants who completed at least one valid post-baseline visit and had available Day 15 data for Response to Therapy (participant evaluation).|||Score on a scale||Standard Deviation|Mean
2525096|NCT03882047|Secondary|Response to Therapy at Day 4 (Participant Evaluation)|Response to therapy was evaluated by participants and based upon their status scored at Day 4. Participants evaluated their response to therapy using the following 5-point scale: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms.|Day 4|All randomized participants who completed at least one valid post-baseline visit and had available Day 4 data for Response to Therapy (participant evaluation).|||Score on a scale||Standard Deviation|Mean
2525097|NCT03882047|Secondary|Response to Therapy at Day 15 (Physician Evaluation)|Response to therapy was assessed by evaluating the participant's relief of nasal symptoms at Day 15. The physician evaluated the participant's response using the following 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms.|Day 15|All randomized participants who completed at least one valid post-baseline visit and had available Day 15 data for Response to Therapy (physician evaluation).|||Score on a scale||Standard Deviation|Mean
2525098|NCT03882047|Secondary|Response to Therapy at Day 4 (Physician Evaluation)|Response to therapy was assessed by evaluating the participant's relief of nasal symptoms at Day 4. The physician evaluated the participant's response using the following 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms.|Day 4|All randomized participants who completed at least one valid post-baseline visit and had available Day 4 data for Response to Therapy (physician evaluation).|||Score on a scale||Standard Deviation|Mean
2525099|NCT03882047|Secondary|Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Participant Evaluation)|The overall condition of seasonal allergic rhinitis was evaluated by the participant on Day 15, based on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.|Baseline (Day 1) and Day 15|All randomized participants who completed at least one valid post-baseline visit and had available Day 15 data for Overall Condition of Seasonal Allergic Rhinitis (participant evaluation)|||Score on a scale||Standard Deviation|Mean
2525100|NCT03882047|Secondary|Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Participant Evaluation)|The overall condition of seasonal allergic rhinitis was evaluated by the participant on Day 4, based on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.|Baseline (Day 1) and Day 4|All randomized participants who completed at least one valid post-baseline visit and had available Day 4 data for Overall Condition of Seasonal Allergic Rhinitis (participant evaluation).|||Score on a scale||Standard Deviation|Mean
2525101|NCT03882047|Secondary|Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Physician Evaluation)|Change from baseline at Day 15 was calculated for the overall condition of seasonal allergic rhinitis, as assessed by the physician. The physician scored their overall condition on study Day 15 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.|Baseline (Day 1) and Day 15|All randomized participants who completed at least one valid post-baseline visit and had available Day 15 data for Overall Condition of Seasonal Allergic Rhinitis (physician evaluated)|||Score on a scale||Standard Deviation|Mean
2525102|NCT03882047|Secondary|Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Physician Evaluation)|Change from baseline at Day 4 was calculated for the Overall Condition of Seasonal Allergic Rhinitis, as assessed by the physician. The physician scored their overall condition on study Day 4 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.|Baseline (Day 1) and Day 4|All randomized participants who completed at least one valid post-baseline visit and had available Day 4 data for Overall Condition of Seasonal Allergic Rhinitis (physician evaluated).|||Score on a scale||Standard Deviation|Mean
2525103|NCT03882047|Secondary|Change From Baseline in the Total Nasal Symptom Score at Day 15 (Physician Evaluation)|Change from baseline at Day 15 was calculated for the Total Nasal Symptom Score, as assessed by the physician. The Total Nasal Symptom Score was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The physician scored each symptom during the study visit on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.|Baseline (Day 1) and Day 15|All randomized participants who completed at least one valid post-baseline visit and had available Day 15 visit data for Total Nasal Symptom Score.|||Score on a scale||Standard Deviation|Mean
2525104|NCT03882047|Secondary|Change From Baseline in the Total Nasal Symptom Score at Day 4 (Physician Evaluation)|Change from baseline at Day 4 was calculated for the Total Nasal Symptom Score, as assessed by the physician. The Total Nasal Symptom Score was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The physician scored each symptom during the study visit on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.|Baseline (Day 1) and Day 4|All randomized participants who completed at least one valid post-baseline visit and had available Day 4 visit data for Total Nasal Symptom Score.|||Score on a scale||Standard Deviation|Mean
2525105|NCT03882047|Primary|Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries)|Change from baseline averaged over study Day 1 through study Day 15 was calculated for Total Nasal Symptom Score, based on participant diaries. Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in their diaries using the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The Total Nasal Symptom Score was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) Change from baseline was the 15-day average score minus the baseline score. Scores were recorded twice daily, in the morning (AM) and night (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. Baseline score was an average of the 3 AM scores and 3 PM scores preceding treatment. Negative changes indicated a decrease in symptom severity.|Baseline and Day 1 through Day 15 (averaged over 15 days)|All randomized participants who completed at least one valid post-baseline visit and had available diary data.|||Score on a scale||Standard Deviation|Mean
2525106|NCT03881670|Secondary|Image Quality Metrics|Root Mean Squared (RMS) wavefront error over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects|0-12 hours||||microns||Standard Deviation|Mean
2525107|NCT03881670|Secondary|Subjective Stability of Vision Rating|Subjects are asked to rate their stability of vision on a numeric rating scale (0, poor to 100 excellent) (Kollbaum 2012). The difference between time 0 and time 12 hours is reported for all subjects (negative number represents a decrease in stability of vision)|0-12 hours||||score on a scale||Standard Deviation|Mean
2525108|NCT03881670|Primary|Higher Order Aberrations|Higher-order Root Mean Squared (RMS) over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects|0-12 hours||||microns||Standard Deviation|Mean
2525115|NCT03878758|Post-Hoc|Subject Satisfaction Survey|Each subject was given a non-comparative 4-question survey on Pen needle characteristics.|At the end of study|Each subject was provided a 4 question survey of their general experience with pen needles. The questions were based on a a 5 point type of Likert scale.|||Participants|||Count of Participants
2525116|NCT03878758|Post-Hoc|Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Needle Breaking)|A needle was considered broken if the patient end and canula was separated into 2 pieces. The number and proportion of needle breaking occurrence for each pen needle type were summarized. The incidence of broken needle events for the BD Nano PRO was compared to each of the 3 comparator products and the mean difference reported with a 95% confidence interval.|Immediately after injection|Per Protocol Population|||Difference in incidence|paired injections|95% Confidence Interval|Mean
2525117|NCT03878758|Other Pre-specified|Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Total Injection Time)|Time from when subject when is depressed and time when removed from body.|Time of injection|Per Protocol Population|||seconds|Pen needles|Standard Deviation|Mean
2525109|NCT03879772|Secondary|Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant|Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity.|Baseline and Days 16 through 29 (average over 15 days)|All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available diary data.|||Scores on a scale||Standard Deviation|Mean
2525110|NCT03879772|Secondary|Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant|Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity.|Baseline and Days 1 through 15 (average over 15 days)|All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available diary data.|||Scores on a scale||Standard Deviation|Mean
2525111|NCT03879772|Secondary|Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator|The mean change from baseline at study day 29 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.|Baseline (Day 1) and Day 29|All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available Day 29 visit data for TNSS.|||Scores on a scale||Standard Deviation|Mean
2525112|NCT03879772|Secondary|Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator|The mean change from baseline at study day 15 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.|Baseline (Day 1) and Day 15|All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available Day 15 visit data for TNSS.|||Scores on a scale||Standard Deviation|Mean
2525113|NCT03879772|Secondary|Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator|The mean change from baseline at study day 4 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.|Baseline (Day 1) and Day 4|All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available Day 4 visit data for TNSS.|||Scores on a scale||Standard Deviation|Mean
2525114|NCT03879772|Primary|Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator|The mean change from baseline at study day 8 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.|Baseline (Day 1) and Day 8|All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available Day 8 visit data for TNSS.|||Scores on a scale||Standard Deviation|Mean
2525135|NCT03870737|Secondary|Weight|A dimensional measure assessed in kg.|Change over Baseline, Week 2, Week 4|Some participants lost to follow up.|||kg.||Standard Error|Least Squares Mean
2525118|NCT03878758|Secondary|Compare BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Force)|Subject perceived force required to deliver dose; measured by a relative 5 point Likert scale. The scale ranged from -2 to 2, where positive scores indicated less thumb force required for the BD Nano™ PRO, and negative scores indicated less thumb force for the comparator. Scores from each of the paired injections were pooled and a mean was calculated.|Immediately after injection Pair|Subjects protocol population with non-missing data|||Score on a scale|paired injections|95% Confidence Interval|Mean
2525119|NCT03878758|Secondary|Superiority of BD Nano™ PRO vs Each of 3 Comparator Pen Needles (Leakage)|After saline delivery equivalent to 30U of U100 insulin (0.3mL) and subject removal of pen needle from body, study staff used the provided materials and scale to absorb leakage from the pen needle tip and injection site to measure the amount of leakage. Leakage over 0.015g was counted as an event. The incidence of leakage (yes/no) was calculated for each groups and the mean difference calculated along with a 95% confidence interval. A positive score indicates fewer leakage events with the BD Nano™ PRO and a negative score indicates fewer leakage events with the competitor. Scores from each injection (308 for each needle type) were pooled and a mean was calculated. The incidence of needle leakage in the BD Nano™ PRO and each comparator were compared and the mean difference reported with a 95% confidence interval.|Leakage was measured directly after each injection|Per protocol population|||Difference in incidence|Pen Needles|95% Confidence Interval|Number
2525120|NCT03878758|Secondary|Needle Bending in BD Nano™ PRO vs Each of 3 Comparator Pen Needles|Participants reported a visual score of needle bending. A score of at least 2, corresponding to >10 degrees of bending, was considered an event of a bent needle. Scores from each injection (308 for each needle type) were pooled and a mean was calculated. The incidence of bent needle events in the BD Nano™ PRO and each competitor were compared and the mean difference reported with a 95% confidence interval.|Scores were collected immediately after each paired injection|Per protocol population|||Difference in incidence|paired injections|95% Confidence Interval|Number
2525121|NCT03878758|Primary|Injection Site Pain for BD Nano PRO Needle Compared to Each of Three (3) Commercially Available Comparators|"Injection pain as measured by a relative visual analog scale. This endpoint analyzes data for individual groups. User preference is assessed through a single question reported on a 150mm relative VAS scale with the BD Nano™ PRO pen needle Pen labeled at +75 mm and the Comparator pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference forBD Nano™ PRO and negative scores reflect preference for the comparator.~Scores from each of the paired injections (308 pairs for all participants) were pooled and a mean was calculated. The two-sided 95% confidence interval was calcuated for the average relative rating. A linear model was used to adjust for the order effect.~If the lower bound of the 95% CI is > -10cm, non-inferiority could be concluded. If the lower bound of the 95% CI is >0, superiority can also be concluded."|Scores were collected immediately after each paired injection|Per-protocol population|||mm|paired injections|95% Confidence Interval|Mean
2525122|NCT03870737|Other Pre-specified|Columbia-Suicide Severity Rating Scale (C-SSRS)|standard instrument to assess potential suicidality with dichotomous scores (0 = absent; 1 = present) to rate various components of suicidal ideation and behavior. Data derived are summarized under Adverse Event Reporting.|Baseline and weekly during 4-week trial|||||||
2525123|NCT03870737|Other Pre-specified|Behavior Rating Inventor of Executive Functioning (BRIEF)|A parent completed rating of child executive function. Comprises 5 sub scales that measure various measures of behavior and cognition. Raw scores on each measure are converted to T scores ranging from 28 to 103, with higher scores indicating greater difficulties.|Change over Baseline and weekly during 4-week trial|||||||
2525124|NCT03870737|Other Pre-specified|Children's Depression Rating Scale - Revised (CDRS-R)|A clinician-completed dimensional measure of childhood mood symptoms obtained from parent and child interview, with range of scores from 17 to 113, and higher scores indicating more severe depression. A score >= 40 suggests depression; scores <= 28 defines remission.|Change over Baseline and Week 4|||||||
2525125|NCT03870737|Other Pre-specified|Multidimensional Anxiety Scale for Children (MASC) - Parent Report|A parent-completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity.|Change over Baseline and Week 4|||||||
2525126|NCT03870737|Other Pre-specified|Multidimensional Anxiety Scale for Children (MASC) - Child Report|A child-completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity.|Change over Baseline and Week 4|||||||
2525127|NCT03870737|Other Pre-specified|Children's Sleep Habits Questionnaire (CSHQ)|A parent-completed 33-item scale to assess sleep related problems. Total scores range from 33 to 99 divided among 8 sub scales , with higher scores indicating more severe difficulties.|Change over Baseline and weekly for 4-week trial|||||||
2525128|NCT03870737|Other Pre-specified|Affective Reactivity Index (ARI-P) Parent|A parent-completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.|Change over Baseline, Week 4|||||||
2525129|NCT03870737|Other Pre-specified|Affective Reactivity Index (ARI-C) Child|A child-completed dimensional measure of emotional reactivity,with scores ranging from 0-12, and higher scores indicating greater severity.|Change over Baseline, Week 4|||||||
2525130|NCT03870737|Other Pre-specified|Conners Global Index - Teacher Report|Teacher completed dimensional rating of ADHD symptoms,with scores ranging from 0-30, and higher scores indicating more severe symptoms.|Change over Baseline and weekly for 4-week trial|||||||
2525131|NCT03870737|Other Pre-specified|Conners Global Index - Parent Report|Parent completed dimensional rating of ADHD symptoms,with score range from 0- 30, and higher scores indicating more severe symptoms.|Change over Baseline and weekly for 4-week trial|||||||
2525132|NCT03870737|Secondary|Pulse|A dimensional measure assessed in heart beats per minute.|Change over Baseline, Week 2, Week 4|Some participants lost to follow up.|||heart beats per minute.||Standard Error|Least Squares Mean
2525133|NCT03870737|Secondary|Diastolic Blood Pressure|A dimensional measure assessed in mm HG.|Change over Baseline, Week 2, Week 4|Some participants lost to follow up.|||mm Hg.||Standard Error|Least Squares Mean
2525134|NCT03870737|Secondary|Systolic Blood Pressure|A dimensional measure assessed in mm HG.|Change over Baseline, Week 2, Week 4|Some participants lost to follow up.|||mm Hg.||Standard Error|Least Squares Mean
2527857|NCT03546270|Secondary|Systolic Blood Pressure|systolic blood pressure|20-weeks||||millimeters of mercury (mmHg)||Standard Deviation|Mean
2525137|NCT03870737|Secondary|Clinical Global Impression - Improvement (CGI-I)|"Categorical measure indicating degree improved or not improved compared with global functioning at baseline in the preceding double-blind trial. The base CGI-I scale is a 7-point measure that requires the investigator to assess how much the condition has improved or worsened compared to baseline prior to initiation of treatment. Ratings are (1) very much improved; (2) much improved; (3) minimally improved; (4) no change; (5) minimally worse; (6) much worse; (7) very much worse. For purposes of analysis, the measure is dichotomized such that scores <= 2 signify improved and scores > 2 signify not improved."|Change over Baseline, Week 2, Week 4|Some participants lost to follow up.|||Participants|||Count of Participants
2525138|NCT03870737|Primary|ADHD-IV Rating Scale (ADHD-RS)|A dimensional rating of ADHD symptoms, with scores ranging from 0 to 54, with higher scores signifying worse severity.|Change over Baseline, Week 2, Week 4.|Some participants lost to follow up.|||score on a scale||Standard Error|Least Squares Mean
2525139|NCT03869450|Secondary|Percentage of Participants Assessed as Having Natural Treatment Results|"Blinded evaluator assessed participants by answering Strongly agree/Agree/Neither agree nor disagree/Disagree/Strongly disagree to the question Are the subject's treatment results natural looking?. Having natural treatment results is defined as being assessed with answers Strongly agree or Agree."|8 weeks||||percentage of participants|||Number
2525140|NCT03869450|Secondary|Percentage of Participants With Improved Midface Volume|"A blinded evaluator assessed the fullness of the midface by using a 4-graded scale where 1= fairly full and 4= substantial loss of fullness.~Improved midface volume was defined as at least a 1-grade decrease from baseline."|8 weeks||||percentage of participants||95% Confidence Interval|Number
2525141|NCT03869450|Primary|Percentage of Participants With Aesthetic Improvement of Midface|A blinded evaluator assesses the improvement compared to baseline (pre-treatment) using a 5-graded scale; Worse, No change, Improved, Much improved or Very much improved. Aesthetic improvement of midface is defined as those participants assessed as Improved, Much improved or Very much improved.|8 weeks||||percentage of participants||95% Confidence Interval|Number
2525142|NCT03868631|Secondary|Change in Peak Torque When Doing Leg Extensions|Assessed using an isokinetic dynamometer set at 60 degrees of motion per second (d/s)|Post-12 week intervention||||Newton-meters||Standard Deviation|Mean
2525143|NCT03868631|Primary|Leg Girth Changes|assessed using circumference measurements (cm)|Post-12 week intervention||||centimeter||Standard Deviation|Mean
2525144|NCT03868631|Primary|Muscle Tissue Thickness Change|assessed using changes in muscle thickness assessed by ultrasound (cm)|Post-12 week intervention||||centimeter||Standard Deviation|Mean
2525145|NCT03868631|Primary|Lean Body Mass Change|assessed using dual energy x-ray absorptiometry (DEXA) scan for changes in lean body mass (kg)|Post-12 week intervention||||kilogram||Standard Deviation|Mean
2525146|NCT03866434|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily had a causal relationship with this treatment. An AE was considered a TEAE if it started on or after dosing on Day 1 or if it started before dosing on Day 1 but increased in severity on or after dosing on Day 1 through the end of the study. Number of participants with TEAEs and TESAEs were reported.|From start of study drug administration up to follow-up (up to Day 18)|Safety set included all participants who had taken at least 1 dose of investigational product (anagrelide or omeprazole) and had at least 1 post dose safety assessment.|||Participants|||Count of Participants
2525147|NCT03866434|Primary|Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of 3-Hydroxy (OH)-Anagrelide (Active Metabolite of Anagrelide) in Plasma|AUC(0-infinity) of 3-OH-Anagrelide (Active Metabolite of Anagrelide) in Plasma on Day 1 and Day 8 was reported. For PK outcome measures the reporting groups were split based on administration of Anagrelide alone (Day 1) and Anagrelide in combination with Omeprazole (Day 8) to provide statistical comparison in this single arm study.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12 hours on Day 1 and Day 8, 24 hours on Day 8|PK set included all participants who received at least 1 dose of investigational product (anagrelide or omeprazole) and had at least 1 measurable post dose plasma concentration. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||h*ng/mL||Standard Deviation|Mean
2525148|NCT03866434|Primary|Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity]) of Anagrelide (SPD422) in Plasma|AUC(0-infinity) of Anagrelide (SPD422) in plasma on Day 1 and Day 8 was reported. For PK outcome measures the reporting groups were split based on administration of Anagrelide alone (Day 1) and Anagrelide in combination with Omeprazole (Day 8) to provide statistical comparison in this single arm study.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12 hours on Day 1 and Day 8, 24 hours on Day 8|PK set included all participants who received at least 1 dose of investigational product (anagrelide or omeprazole) and had at least 1 measurable post dose plasma concentration. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||h*ng/mL||Standard Deviation|Mean
2525149|NCT03866434|Primary|Area Under the Concentration Versus Time Curve From Zero to Last Time Point (AUC[0-t]) of 3-Hydroxy (OH)-Anagrelide (Active Metabolite of Anagrelide) in Plasma|AUC(0-t) of 3-OH-Anagrelide (Active Metabolite of Anagrelide) in Plasma on Day 1 and Day 8 was reported. For PK outcome measures the reporting groups were split based on administration of Anagrelide alone (Day 1) and Anagrelide in combination with Omeprazole (Day 8) to provide statistical comparison in this single arm study.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12 hours on Day 1 and Day 8, 24 hours on Day 8|PK set included all participants who received at least 1 dose of investigational product (anagrelide or omeprazole) and had at least 1 measurable post dose plasma concentration.|||h*ng/mL||Standard Deviation|Mean
2525150|NCT03866434|Primary|Area Under the Concentration Versus Time Curve From Zero to Last Time Point (AUC[0-t]) of Anagrelide (SPD422) in Plasma|AUC(0-t) of Anagrelide (SPD422) in plasma on Day 1 and Day 8 was reported. For PK outcome measures the reporting groups were split based on administration of Anagrelide alone (Day 1) and Anagrelide in combination with Omeprazole (Day 8) to provide statistical comparison in this single arm study.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12 hours on Day 1 and Day 8, 24 hours on Day 8|PK set included all participants who received at least 1 dose of investigational product (anagrelide or omeprazole) and had at least 1 measurable post dose plasma concentration.|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
2525151|NCT03866434|Primary|Maximum Observed Plasma Concentration (Cmax) of 3-Hydroxy (OH)-Anagrelide (Active Metabolite of Anagrelide)|Cmax of 3-OH-Anagrelide (Active Metabolite of Anagrelide) on Day 1 and Day 8 was reported. For PK outcome measures the reporting groups were split based on administration of Anagrelide alone (Day 1) and Anagrelide in combination with Omeprazole (Day 8) to provide statistical comparison in this single arm study.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12 hours on Day 1 and Day 8, 24 hours on Day 8|PK set included all participants who received at least 1 dose of investigational product (anagrelide or omeprazole) and had at least 1 measurable post dose plasma concentration.|||ng/mL||Standard Deviation|Mean
2525152|NCT03866434|Primary|Maximum Observed Plasma Concentration (Cmax) of Anagrelide (SPD422)|Cmax of Anagrelide (SPD422) on Day 1 and Day 8 was reported. For PK outcome measures the reporting groups were split based on administration of Anagrelide alone (Day 1) and Anagrelide in combination with Omeprazole (Day 8) to provide statistical comparison in this single arm study.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12 hours on Day 1 and Day 8, 24 hours on Day 8|Pharmacokinetic (PK) set included all participants who received at least 1 dose of investigational product (anagrelide or omeprazole) and had at least 1 measurable post dose plasma concentration.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2525153|NCT03861559|Secondary|Therapeutic Response to Treatment at Day 15 as Assessed by Participant|Mean therapeutic response to treatment was assessed by the participant using diary cards on Day 15. Treatment response was evaluated by the participant using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms.|Day 15|All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.|||Score on a scale||Standard Deviation|Mean
2525154|NCT03861559|Secondary|Therapeutic Response to Treatment at Day 8 as Assessed by Participant|Mean therapeutic response to treatment was assessed by the participant using diary cards on Day 8. Treatment response was evaluated by the participant using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms.|Day 8|All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.|||Score on a scale||Standard Deviation|Mean
2525155|NCT03861559|Secondary|Therapeutic Response to Treatment at Day 4 as Assessed by Participant|Mean therapeutic response to treatment was assessed by the participant using diary cards on Day 4. Treatment response was evaluated by the participant using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms.|Day 4|All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.|||Score on a scale||Standard Deviation|Mean
2525156|NCT03861559|Secondary|Therapeutic Response to Treatment at Day 15 as Assessed by Investigator|Mean therapeutic response to treatment was assessed by evaluating the participant's relief of nasal symptoms during study visit on study Day 15. Treatment response was evaluated by the investigator using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms. Signs and symptoms data collected by the investigator for Day 15 were not evaluated because the data was missing from the case report forms. The final endpoint was calculated using the last valid visit for each participant.|Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.|All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.|||Score on a scale||Standard Deviation|Mean
2525157|NCT03861559|Secondary|Therapeutic Response to Treatment at Day 8 as Assessed by Investigator|Mean therapeutic response to treatment was assessed by evaluating the participant's relief of nasal symptoms during study visit on study Day 8. Treatment response was evaluated by the investigator using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms.|Day 8|All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.|||Score on a scale||Standard Deviation|Mean
2525158|NCT03861559|Secondary|Therapeutic Response to Treatment at Day 4 as Assessed by Investigator|Mean therapeutic response to treatment was assessed by evaluating the participant's relief of nasal symptoms during study visit on study Day 4. Treatment response was evaluated by the investigator using a 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group with a lower score indicating a greater response to treatment and an improvement in nasal symptoms.|Day 4|All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.|||Score on a scale||Standard Deviation|Mean
2525159|NCT03861559|Other Pre-specified|Baseline Overall Disease Condition Score for Calculation of Change From Baseline at Days 4, 8, and 15 as Assessed by Participant|The participant scored the overall condition of seasonal allergic rhinitis in a diary using the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. The baseline score was recorded preceding treatment.|Baseline (Day 1)|All randomized participants who took ≥1 dose of study medication and provided at least 1 baseline endpoint observation|||Score on a scale||Standard Deviation|Mean
2525245|NCT03850496|Primary|Disease Specific Quality of Life Measure - Aberdeen Varicose Vein Questionnaire|Assessment using the Aberdeen Varicose Vein Questionnaire disease specific questionnaire on quality of life. Assessed at baseline and at 6 weeks. Scored from 0-100. 100 worst 0 best.|6 weeks||||Scores on a scale (0-100)||Inter-Quartile Range|Median
2525427|NCT03832387|Secondary|Duration of Global Mechanical Ventilation|Duration of mechanical ventilation until unsupported ventilation|From start of mechanical ventilation to one month||||days||Inter-Quartile Range|Median
2525160|NCT03861559|Secondary|Change From Baseline (CFB) in Overall Disease Condition Score at Day 15 as Assessed by Participant|CFB on study Day 15 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the participant. The participant scored their overall condition on study Day 15 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 15 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.|Baseline (Day 1) and Day 15|All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.|||Percent change||Standard Deviation|Mean
2525161|NCT03861559|Secondary|Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Participant|CFB on study Day 8 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the participant. The participant scored their overall condition on study Day 8 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 8 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.|Baseline (Day 1) and Day 8|All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.|||Percent change||Standard Deviation|Mean
2525162|NCT03861559|Secondary|Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Participant|CFB on study Day 4 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the participant. The participant scored their overall condition on study Day 4 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 4 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.|Baseline (Day 1) and Day 4|All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.|||Percent change||Standard Deviation|Mean
2525163|NCT03861559|Other Pre-specified|Baseline Overall Disease Condition Score for Calculation of Change From Baseline at Days 4, 8, and 15 Visits as Assessed by Investigator|The investigator scored the overall condition of seasonal allergic rhinitis for the participant during the study visits using the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. The baseline score was taken at the baseline visit preceding treatment.|Baseline (Day 1)|All randomized participants who took ≥1 dose of study medication and provided at least 1 baseline endpoint observation|||Score on a scale||Standard Deviation|Mean
2525164|NCT03861559|Secondary|Change From Baseline in Overall Disease Condition Score at Day 15 as Assessed by Investigator|CFB on study Day 15 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the investigator. The investigator scored the overall condition of the participant during the study visit on study Day 15 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 15 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms. Signs and symptoms data collected by the investigator for Day 15 were not evaluated because the data was missing from the case report forms. The final endpoint was calculated using the last valid visit for each participant.|Baseline (Day 1) and Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.|All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.|||Percent change||Standard Deviation|Mean
2525165|NCT03861559|Secondary|Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Investigator|CFB on study Day 8 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the investigator. The investigator scored the overall condition of the participant during the study visit on study Day 8 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 8 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.|Baseline (Day 1) and Day 8|All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.|||Percent change||Standard Deviation|Mean
2525166|NCT03861559|Secondary|Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Investigator|CFB on study Day 4 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the investigator. The investigator scored the overall condition of the participant during the study visit on study Day 4 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 4 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.|Baseline (Day 1) and Day 4|All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.|||Percent change||Standard Deviation|Mean
2525167|NCT03861559|Other Pre-specified|Baseline Total Nasal Symptom Score (TNSS) for Calculation of Change From Baseline at Days 4, 8, and 15 Visits as Assessed by Investigator|TNSS was assessed by the investigator who scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries using the scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. The baseline score was taken at the baseline visit preceding treatment.|Baseline (Day 1)|All randomized participants who took ≥1 dose of study medication and provided at least 1 baseline endpoint observation.|||Score on a scale||Standard Deviation|Mean
2525422|NCT03832387|Secondary|Rate of Urinary Tract Infection|Percentage of participants with urinary tract infection during intensive care unit stay|From intensive care unit admission to 2 months||||Participants|||Count of Participants
2525168|NCT03861559|Secondary|Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 15 as Assessed by Investigator|CFB at Day 15 was calculated for TNSS assessed by the investigator. TNSS was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The investigator scored each symptom during study visit on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and endpoint scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms. Signs and symptoms data collected by the investigator for Day 15 were not evaluated because the data was missing from the case report forms. The final endpoint was calculated using the last valid visit for each participant.|Baseline (Day 1) and Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.|All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.|||Percent change||Standard Deviation|Mean
2525169|NCT03861559|Secondary|Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator|CFB on study Day 8 was calculated for TNSS assessed by investigator. TNSS was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The investigator scored each symptom during study visit on study Day 8 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 8 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.|Baseline (Day 1) and Day 8|All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.|||Percent change||Standard Deviation|Mean
2525170|NCT03861559|Secondary|Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 4 as Assessed by Investigator|CFB on study Day 4 was calculated for TNSS assessed by investigator. TNSS was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The investigator scored each symptom during study visit on study Day 4, on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 4 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.|Baseline (Day 1) and Day 4|All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.|||Percent change||Standard Deviation|Mean
2525171|NCT03861559|Other Pre-specified|Baseline Total Nasal Symptom Score (TNSS) for Calculation of Change From Baseline Averaged Over 15 Days of Treatment as Assessed by Participant|TNSS was assessed by participants who scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries using the scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. Scores were recorded twice daily, in morning (AM) and night (PM). The baseline score was an average of the three AM and three PM scores preceding treatment.|Baseline (3 days preceding treatment)|All randomized participants who took ≥1 dose of study medication and provided ≥1 baseline endpoint observation for the calculation of the CFB in TNSS averaged over 15 days. Baseline data was missing for 1 participant in the mometasone furoate nasal spray group for this endpoint and the participant was excluded from the analysis.|||Score on a scale||Standard Deviation|Mean
2525172|NCT03861559|Secondary|Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) Averaged Over 15 Days of Treatment, as Assessed by Participant|"CFB, averaged over study days 1-15, was calculated for TNSS assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries using the scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. A decrease in symptom severity is reflected by a negative CFB.~Percent CFB was calculated as the difference between the baseline and 15-day average scores divided by baseline score multiplied by 100. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores were first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score was an average of the three AM and three PM scores preceding treatment."|Baseline (3 days preceding treatment) through Day 15 (averaged over 15 days)|All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed. Baseline data was missing for 1 participant in the mometasone furoate nasal spray group for this endpoint and the participant was excluded from the analysis.|||Percent change||Standard Deviation|Mean
2525173|NCT03861559|Primary|Median Time to Onset of Nasal Symptom Relief as Assessed by Participant Diary Responses|"Time to onset of relief of nasal stuffiness/congestion, rhinorrhea, nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of eyes, and itching of ears or palate was assessed by the participant using diary response data in the morning and night for the first 3 days of treatment. The participants were asked to rate their relief on the following scale: 1=complete, 2=marked, 3=moderate, 4=slight, and 5=none. If a participant recorded a degree of relief that was at least moderate (3 or below), they answered the question, When did you first experience noticeable relief? and noted the date and time. The data were analyzed using a log ranked test and with a Kaplan-Meier estimate. Any participant who did not experience at least moderate relief by the end of 72 hours was considered censored at that time in the analysis. Time to onset of relief is presented in hours."|From the start of treatment until onset of symptom relief (up to Day 4)|Included randomized participants with ≥1 valid post-baseline visit, had evaluable data for the endpoint, and experienced at least moderate relief by the end of 72 hours of treatment.|||Hours||Full Range|Median
2525269|NCT03849300|Secondary|Systemic Arterial Stiffness|Systemic arterial stiffness was estimated as measurement of brachial-to-ankle pulse wave velocity (meters per second). A higher value represents a worse outcome. Scale range is approximately 7.0 - 14.0 meters per second for healthy populations.|12 weeks||||meters per second||Standard Deviation|Mean
2525174|NCT03859622|Secondary|Specific Number of Patients of the Whole Practice Population Whose Electronic Health Records (EHRs) Were Assessed.|The specific number of participants of the practice population with a prescription of drugs metabolized by CYP 2D6 within the last 3 years. These data were extracted from the electronic health records (EHRs) of the practice office. For this data extraction enrollement in the study and signing an informed consent was not necessary. No other data (i.e. baseline assessments, other outcome measures and adverse events) were collected in this group.|1 Year|Specific number of participants of the whole practice population with a prescription of a CYP2D6 relevant drug. Participants belonging to this specific group did not need to sign an informed consent form. No other data (i.e. baseline assessments, other outcome measures and adverse events) were collected in this group.|||Participants|||Count of Participants
2525175|NCT03859622|Secondary|Number of Participants in Whom the Family Physician Considered Prior Knowledge of Their Metabolizer Status Important Before the CYP2D6-specific Drug Was Prescriped.|In how many patients would family physician`s knowledge of the CYP 2D6 metabolizer status (ultrarapid (UM), normal (NM), intermediate (IM) and poor (PM)) have been of importance before prescribing a CYP2D6 specific drug. Remark: The relevant drug has already already been prescribed before analysis has been taken place.|1 Year|289 unselected consecutive patients with a prescription of a CYP2D6 relevant drug during the last 3 years visiting the practice office for a routine blood test. Due to technical problems only 287 could be analyzed.|||Participants|||Count of Participants
2525176|NCT03859622|Primary|Frequency of CYP2D6 Genotypes in Patients|"The frequency of 61 different CYP2D6 genotypes in 287 patients is determined. In 2 out of all 289 patients the determination was not possible due to technical problems.~Remark: each participant possesses a) two individual CYP2D6 alleles, b) from the combination of these two alleles one individual genotype is derived and c) from this genotype the genetically determined metabolizer status (PM, IM, NM, UM) is derived."|1 Year|289 unselected consecutive patients with a prescription of a CYP2D6 relevant drug during the last 3 years and who are visiting the practice office for a routine blood test. Due to technical problems the genotypes of two patients could not be determined!|||Participants|||Count of Participants
2525177|NCT03859622|Primary|Frequency of CYP2D6 Alleles in Patients|"The frequency of 19 different CYP2D6 alleles in 287 patients is determined. In 2 out of all 289 patients the determination was not possible due to technical problems.~Remark: each participant possesses a) two individual CYP2D6 alleles, b) from the combination of these two alleles one individual genotype is derived and c) from this genotype the genetically determined metabolizer status (PM, IM, NM, UM) is derived."|1 Year|In 289 unselected consecutive patients visiting the practice office for a routine blood test for various chronic medical conditions and only in case the patient has been prescribed a drug metabolized by the CYP2D6 enzyme (or a drug which is a strong inhibitor of CYP2D6) within the last 3 years, his or her CYP2D6 alleles are analyzed.|||Participants|||Count of Participants
2525178|NCT03859622|Primary|Frequency of Metabolizer Status (PM, IM, NM, UM) in Patients|"Remark: each participant possesses a) two individual CYP2D6 alleles, b) from the combination of these two alleles one individual genotype is derived and c) from this genotype the genetically determined metabolizer status (PM, IM, NM, UM) is derived.~A patient can be considered a ultra-rapid (UM), a normal (NM), an intermediate (IM), or a poor metabolizer (PM) of a given drug"|1 Year|289 unselected consecutive patients with a prescription of a CYP2D6 relevant drug during the last 3 years and who are visiting the practice office for a routine blood test. Due to technical problems the metabolizer status of two patients could not be determined!|||Participants|||Count of Participants
2525179|NCT03857243|Secondary|Wolf Motor Function Test|"Timed performance of 15 functional upper extremity tasks, 0-120 seconds, and 2 strength measures.~WMFT time measurements are calculated as the arithmetic mean of rate of performance, where we calculate how many times would a person have completed the task, had he or she been performing it continuously for 60 seconds. Therefore the results have a minimum score of 0, where the subject could not perform any of the tasks, and no pre-defined maximum score, the higher the rate score the faster the subject was able to perform the tasks. ( see Hodics et al.,2013)"|change between before and at 3 months follow-up|One subject finished the treatment, statistical analysis was not performed||||||
2525180|NCT03857243|Primary|Upper Extremity Fugl-Meyer Score|Upper extremity motor impairment scale. Scale ranges from 0 (worst, can not perform any tasks) to 66 ( performs all tasks fully).|change between before and 3 months follow-up|One subject finished the treatment, statistical analysis was not performed||||||
2525181|NCT03857243|Primary|Adverse Events|any adverse events that might be related to study procedures|enrollment to 3 month followup||||number of events|||Number
2525182|NCT03857230|Other Pre-specified|Elimination Rate Constant (Kel)|Elimination rate constant (Kel): Time frame: From 0 (predose), 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 120, 168 and 192 hours postdose.|0-192 hours||||1/h||Standard Deviation|Mean
2525183|NCT03857230|Secondary|Follicle Stimulating Hormone (FSH) Apparent Terminal Half-life (T1/2)|Terminal half-life (T1/2), Time frame: From 0 (predose), 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 120, 168 and 192 hours postdose.|0-192 hours||||hours||Standard Deviation|Geometric Least Squares Mean
2525184|NCT03857230|Secondary|Time to Reach a Maximum Follicle Stimulating Hormone (FSH) Serum Concentration (Tmax)|Time to reach a maximum serum concentration (Tmax), Time frame: From 0 (predose), 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 120, 168 and 192 hours postdose.|0-192 hours||||hours||Standard Deviation|Mean
2525185|NCT03857230|Primary|Maximum Serum Concentration of Follicle Stimulating Hormone (FSH) (Cmax)|Maximum serum concentration (Cmax), Time frame: From 0 (predose), 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 120, 168 and 192 hours postdose.|0-192 hours||||mIU/ml||Standard Deviation|Geometric Mean
2525194|NCT03855228|Secondary|Change From Baseline in Total Nasal Symptom Score on Day 15 (Assessed by Physician)|"The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity.~A negative change from baseline indicates a decrease in symptom severity."|Baseline and study day 15|All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.|||Score on a scale||Standard Deviation|Mean
2525186|NCT03857230|Primary|Area Under the Serum Concentration of Follicle Stimulating Hormone (FSH) - Time Curve (AUC(0-192))|"Area under curve (AUC), Time frame: From 0 (predose), 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 120, 168 and 192 hours postdose.~Blood samples to study the pharmacokinetics are to be collected via a venous catheter, which is placed by means of vein puncture before any injection of r-hFSH. Blood sampling were carried out at certain time points according to the specified scheme: - 20 minutes (20 minutes before the drug injection), 0 hours (immediately prior to injection), and 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 120, 168, and 192 hours after each injection of the drug product."|0-192 hours|Blood sampling were carried out at certain time points according to the specified scheme: - 20 minutes (20 minutes before the drug injection), 0 hours (immediately prior to injection), and 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 120, 168, and 192 hours after each injection of the drug product.|||mIU*h/ml||Standard Deviation|Geometric Mean
2525187|NCT03855228|Secondary|Response to Therapy on Day 8 (Assessed by Physician)|Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 8. A higher value indicates weaker response.|Study day 8|All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.|||Score on a scale||Standard Deviation|Mean
2525188|NCT03855228|Secondary|Response to Therapy on Day 15 (Assessed by Physician)|Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 15. A higher value indicates weaker response.|Study day 15|All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.|||Score on a scale||Standard Deviation|Mean
2525189|NCT03855228|Secondary|Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 8 (Assessed by Physician)|"The mean change from baseline on study day 8 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity.~A negative change from baseline indicates a decrease in symptom severity."|Baseline and study day 8|All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.|||Score on a scale||Standard Deviation|Mean
2525190|NCT03855228|Secondary|Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 15 (Assessed by Physician)|"The mean change from baseline on study day 15 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity.~A negative change from baseline indicates a decrease in symptom severity."|Baseline and study day 15|All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.|||Score on a scale||Standard Deviation|Mean
2525191|NCT03855228|Secondary|Change From Baseline in Total Symptom Score on Day 8 (Assessed by Physician)|"The mean change from baseline on study day 8 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity.~A negative change from baseline indicates a decrease in symptom severity."|Baseline and study day 8|All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.|||Score on a scale||Standard Deviation|Mean
2525192|NCT03855228|Secondary|Change From Baseline in Total Nasal Symptom Score on Day 8 (Assessed by Physician)|"The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity.~A negative change from baseline indicates a decrease in symptom severity."|Baseline and study day 8|All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.|||Score on a scale||Standard Deviation|Mean
2525193|NCT03855228|Secondary|Change From Baseline in Total Symptom Score on Day 15 (Assessed by Physician)|"The mean change from baseline on study day 15 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity.~A negative change from baseline indicates a decrease in symptom severity."|Baseline and study day 15|All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.|||Score on a scale||Standard Deviation|Mean
2525242|NCT03850496|Secondary|Venous Flow Parameters - VF|Assessment of change in venous flow utilising Volume Flow (VF) (measured in cc/min), assessed as percentage change from baseline.|6 weeks|||||||
2525243|NCT03850496|Secondary|Venous Flow Parameters - PV|Assessment of change in venous flow utilising Peak Velocity (PV) (measured in cm/s), assessed as percentage change from baseline.|6 weeks|||||||
2525195|NCT03855228|Primary|Change From Baseline in Total Symptom Score (Assessed by Participant)|"Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total symptom scores assessed by participants. Participants scored 8 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing; itching/burning eyes; tearing/watering eyes; eye redness; and ear/palate itching) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total symptom score (range: 0-24); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB.~CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment."|Baseline and days 1 through 15 (average of 15 days of treatment)|Includes randomized participants with ≥1 valid post-Baseline visit, no major protocol violations, and evaluable data for the days 1-15 average.|||Score on a scale||Standard Deviation|Mean
2525196|NCT03855228|Primary|Change From Baseline in Total Nasal Symptom Score (Assessed by Participant)|"Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total nasal symptom scores assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total nasal symptom score (range: 0-12); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB.~CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment."|Baseline and days 1 through 15 (average of 15 days of treatment)|Includes randomized participants with ≥1 valid post-Baseline visit, no major protocol violations, and evaluable data for the days 1-15 average.|||Score on a scale||Standard Deviation|Mean
2525197|NCT03855189|Secondary|Response To Therapy At Day 29 (Participant-Evaluated)|Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.|Day 29|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for response (participant-evaluated).|||scores on a scale||Standard Deviation|Mean
2525198|NCT03855189|Secondary|Response To Therapy At Day 22 (Participant-Evaluated)|Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.|Day 22|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for response (participant-evaluated).|||scores on a scale||Standard Deviation|Mean
2525199|NCT03855189|Secondary|Response To Therapy At Day 15 (Participant-Evaluated)|Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.|Day 15|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for response (participant-evaluated).|||scores on a scale||Standard Deviation|Mean
2525200|NCT03855189|Secondary|Response To Therapy At Day 8 (Participant-Evaluated)|Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.|Day 8|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for response (participant-evaluated).|||scores on a scale||Standard Deviation|Mean
2525201|NCT03855189|Secondary|Response To Therapy At Day 4 (Participant-Evaluated)|Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.|Day 4|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for response (participant-evaluated).|||scores on a scale||Standard Deviation|Mean
2525202|NCT03855189|Secondary|Response To Therapy At Day 29 (Physician-Evaluated)|Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.|Day 29|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for response (physician-evaluated).|||scores on a scale||Standard Deviation|Mean
2525203|NCT03855189|Secondary|Response To Therapy At Day 22 (Physician-Evaluated)|Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.|Day 22|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for response (physician-evaluated).|||scores on a scale||Standard Deviation|Mean
2525244|NCT03850496|Secondary|Venous Flow Parameters - TAMV|Assessment of change in venous flow utilising Time Averaged Mean Velocity (TAMV) (measured in cm/s), assessed as percentage change from baseline.|6 weeks|||||||
2525474|NCT03822884|Primary|AUC0-t|AUC0-t: Area under the serum concentration curve from time 0 to time t (in this case, 120 hours).|120 h||||mUI*h/mL||Standard Deviation|Mean
2525204|NCT03855189|Secondary|Response To Therapy At Day 15 (Physician-Evaluated)|Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.|Day 15|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for response (physician-evaluated).|||scores on a scale||Standard Deviation|Mean
2525205|NCT03855189|Secondary|Response To Therapy At Day 8 (Physician-Evaluated)|Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.|Day 8|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for response (physician-evaluated).|||scores on a scale||Standard Deviation|Mean
2525206|NCT03855189|Secondary|Response To Therapy At Day 4 (Physician-Evaluated)|Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.|Day 4|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for response (physician-evaluated).|||scores on a scale||Standard Deviation|Mean
2525207|NCT03855189|Secondary|Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Participant-Evaluated)|Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.|Baseline (Day 1), Day 29|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for SAR overall condition (participant-evaluated).|||scores on a scale||Standard Deviation|Mean
2525208|NCT03855189|Secondary|Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Participant-Evaluated)|Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.|Baseline (Day 1), Day 22|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for SAR overall condition (participant-evaluated).|||scores on a scale||Standard Deviation|Mean
2525209|NCT03855189|Secondary|Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Participant-Evaluated)|Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.|Baseline (Day 1), Day 15|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for SAR overall condition (participant-evaluated).|||scores on a scale||Standard Deviation|Mean
2525210|NCT03855189|Secondary|Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Participant-Evaluated)|Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.|Baseline (Day 1), Day 8|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for SAR overall condition (participant-evaluated).|||scores on a scale||Standard Deviation|Mean
2525211|NCT03855189|Secondary|Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Participant-Evaluated)|Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.|Baseline (Day 1), Day 4|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for SAR overall condition (participant-evaluated).|||scores on a scale||Standard Deviation|Mean
2525212|NCT03855189|Secondary|Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Physician-Evaluated)|Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.|Baseline (Day 1), Day 29|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for SAR overall condition (physician-evaluated).|||scores on a scale||Standard Deviation|Mean
2525213|NCT03855189|Secondary|Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Physician-Evaluated)|Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.|Baseline (Day 1), Day 22|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for SAR overall condition (physician-evaluated).|||scores on a scale||Standard Deviation|Mean
2525214|NCT03855189|Secondary|Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Physician-Evaluated)|Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.|Baseline (Day 1), Day 15|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for SAR overall condition (physician-evaluated).|||scores on a scale||Standard Deviation|Mean
2525215|NCT03855189|Secondary|Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Physician-Evaluated)|Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.|Baseline (Day 1), Day 8|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for SAR overall condition (physician-evaluated).|||scores on a scale||Standard Deviation|Mean
2525216|NCT03855189|Secondary|Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Physician-Evaluated)|Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.|Baseline (Day 1), Day 4|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for SAR overall condition (physician-evaluated).|||scores on a scale||Standard Deviation|Mean
2525217|NCT03855189|Secondary|Change From Baseline in the TNSS At Day 29 (Physician-Evaluated)|TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.|Baseline (Day 1), Day 29|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for TNSS.|||scores on a scale||Standard Deviation|Mean
2525218|NCT03855189|Secondary|Change From Baseline in the TNSS At Day 22 (Physician-Evaluated)|TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.|Baseline (Day 1), Day 22|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for TNSS.|||scores on a scale||Standard Deviation|Mean
2525219|NCT03855189|Secondary|Change From Baseline in the TNSS At Day 15 (Physician-Evaluated)|TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.|Baseline (Day 1), Day 15|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for TNSS.|||scores on a scale||Standard Deviation|Mean
2525220|NCT03855189|Secondary|Change From Baseline in the TNSS At Day 8 (Physician-Evaluated)|TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.|Baseline (Day 1), Day 8|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for TNSS.|||scores on a scale||Standard Deviation|Mean
2525221|NCT03855189|Primary|Number of Participants Who Discontinued Treatment Due to An Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who discontinued due to an AE was reported for each treatment group.|Up to 31 Days|All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.|||Participants|||Count of Participants
2525222|NCT03855189|Primary|Number of Participants Who Experienced ≥1 Adverse Event|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants with at least one AE was reported for each treatment group.|Up to 31 Days|All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.|||Participants|||Count of Participants
2525223|NCT03855189|Secondary|Change From Baseline in the TNSS At Day 4 (Physician-Evaluated)|TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.|Baseline (Day 1), Day 4|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for TNSS.|||scores on a scale||Standard Deviation|Mean
2525224|NCT03855189|Primary|Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated)|TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching, as rated in their diary in the morning (AM) and evening (PM). The 4 individual symptom scores rated as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For the 15 day interval, participant individual daily scores were totaled and averaged over interval (AM and PM computed separately then averaged) and used to calculate the overall average change from Baseline. Participant average changes were then used to calculate the mean change for each arm for the interval. Average change from Baseline for Days 1-15 = average post-treatment score (Days 1-15) - Baseline average score (average of the Baseline AM/PM diary scores from 3 consecutive days prior to Baseline visit). Negative changes from baseline indicate a decrease in symptom severity.|Baseline, and Days 1 through 15 (average of 15 days of treatment)|All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available diary data.|||score on a scale||Standard Deviation|Mean
2525225|NCT03854253|Secondary|Number of Participants With a Bleeding of the Puncture Site.|Rate of access site complications during percutaneous procedures performed via a transradial approach.|up to 10 days||||Participants|||Count of Participants
2525226|NCT03854253|Secondary|Number of Participants With Median Nerve Neuritis|Rate of access site complications during percutaneous procedures performed via a transradial approach|up to 10 days||||Participants|||Count of Participants
2525227|NCT03854253|Secondary|Number of Participants With a Perforation / Dissection of a Radial Artery.|Rate of access site complications during percutaneous procedures performed via a transradial approach|up to 10 days||||Participants|||Count of Participants
2525228|NCT03854253|Secondary|Total Air Kerma|Total air kerma, mGy|up to 10 days||||mGy||Standard Deviation|Median
2525229|NCT03854253|Secondary|Fluoroscopy Time|Fluoroscopy time, sec|up to 10 days||||seconds||Inter-Quartile Range|Median
2525230|NCT03854253|Secondary|Time of the Procedure|Time from insertion of the introducer to finish the procedure|up to 10 days||||seconds||Inter-Quartile Range|Median
2525231|NCT03854253|Secondary|Time of the Introducer Insertion|Time from start punction of the radial artery to full insertion of the introducer|up to 10 days||||seconds||Inter-Quartile Range|Median
2525232|NCT03854253|Secondary|Rate of Conversion of Needle Type|Rate of conversion type of Needle type during percutaneous procedures performed via a transradial approach.|up to 10 days||||Participants|||Count of Participants
2525233|NCT03854253|Secondary|Number of Participants With a Hematoma, Stage I|Rate of access site complications during percutaneous procedures performed via a transradial approach. Local hematomas are classified according to the following scale: I - diameter not more than 5 cm, II - not more than 10 cm, III - not more than 10 cm, but not higher than the elbow, IV - above the elbow, V - with the threat of hand ischemia [Bertrand, O. F., De Larochelliere, R., Rodes-Cabau, J., Proulx, G., Gleeton, O., Manh Nguyen, C., Dery J.P., Barbeau G., Noel B., Larose E., Poirier P., Roy L. A Randomized Study Comparing Same-Day Home Discharge and Abciximab Bolus Only to Overnight Hospitalization and Abciximab Bolus and Infusion After Transradial Coronary Stent Implantation. Circulation, 2006 114(24), 2636-2643.doi:10.1161/circulationaha.106.638627]. Hematomas more than stage I were not recorded in both groups.|up to 10 days||||Participants|||Count of Participants
2525234|NCT03854253|Primary|Number of Participants With Radial Artery Occlusion|Participants who diagnosed a radial artery occlusion with color Doppler ultrasound.|up to 10 days||||Participants|||Count of Participants
2525235|NCT03850496|Secondary|Generic Quality of Life - EQ-VAS|Quality of life as assessed by the EuroQol Visual Analogue Scale (0-100) for generic Quality of life - EQ-VAS|6 weeks|||||||
2525236|NCT03850496|Secondary|Generic Quality of Life - SF-12|Quality of life as assessed by the Short Form 12 (SF-12) generic quality of life tool. Assessed at baseline and 6 weeks.|6 weeks|||||||
2525237|NCT03850496|Secondary|Generic Quality of Life - EQ-5D|Quality of life as assessed by the EuroQol EQ-5D generic quality of life questionnaire.|6 weeks|||||||
2525238|NCT03850496|Secondary|Patient Compliance|Compliance with device usage assessed with a patient completed diary.|6 weeks.|||||||
2525239|NCT03850496|Secondary|Venous Clinical Severity|Clinical severity of venous disease as measured by the venous clinical severity score (VCSS).|6 weeks.|||||||
2525240|NCT03850496|Secondary|Limb Volume|Change in limb volume assessed in ml.|6 weeks|||||||
2525241|NCT03850496|Secondary|Microcirculatory Blood Flow|Microcirculatory blood flow measure utilising flux arbitrary units.|6 weeks.|||||||
2525246|NCT03850444|Secondary|Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented. These safety results are based on a 04-September-2018 data cutoff date.|Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)|The analysis population consisted of all participants who received ≥1 dose of study treatment.|||Participants|||Count of Participants
2525247|NCT03850444|Secondary|Number of Participants Who Experienced At Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented. These safety results are based on a 04-September-2018 data cutoff date.|Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)|The analysis population consisted of all participants who received ≥1 dose of study treatment.|||Participants|||Count of Participants
2525248|NCT03850444|Secondary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥1%|ORR was determined for participants with a TPS of ≥1%. ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target and non-target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The percentage of participants who had a TPS ≥1% and who experienced a CR or PR is presented.|Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)|The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥1%.|||Percentage of participants||95% Confidence Interval|Number
2525249|NCT03850444|Secondary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥20%|ORR was determined for participants with a TPS of ≥20%. ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target and non-target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The percentage of participants who had a TPS ≥20% and who experienced a CR or PR is presented.|Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)|The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥20%.|||Percentage of participants||95% Confidence Interval|Number
2525250|NCT03850444|Secondary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥50%|ORR was determined for participants with a TPS of ≥50%. ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target and non-target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The percentage of participants who had a TPS ≥50% and who experienced a CR or PR is presented.|Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)|The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥50%.|||Percentage of participants||95% Confidence Interval|Number
2525251|NCT03850444|Secondary|Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥1%|PFS was determined for participants with a TPS of ≥1% and was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions or progression in non-target lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The PFS for participants with a TPS ≥1% is presented.|Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)|The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥1%.|||Months||95% Confidence Interval|Median
2525252|NCT03850444|Secondary|Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥20%|PFS was determined for participants with a TPS of ≥20% and was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions or progression in non-target lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The PFS for participants with a TPS ≥20% is presented.|Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)|The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥20%.|||Months||95% Confidence Interval|Median
2525253|NCT03850444|Secondary|Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥50%|PFS was determined for participants with a TPS of ≥50% and was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions or progression in non-target lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The PFS for participants with a TPS ≥50% is presented.|Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)|The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥50%.|||Months||95% Confidence Interval|Median
2525254|NCT03850444|Primary|Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥1%|OS was determined for participants with a TPS of ≥1% and was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. The OS for participants with a TPS ≥1% is presented.|Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)|The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥1%.|||Months||95% Confidence Interval|Median
2525255|NCT03850444|Primary|Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥20%|OS was determined for participants with a TPS of ≥20% and was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. The OS for participants with a TPS ≥20% is presented.|Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)|The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥20%.|||Months||95% Confidence Interval|Median
2525256|NCT03850444|Primary|Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥50%|OS was determined for participants with a TPS of ≥50% and was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. The OS for participants with a TPS ≥50% is presented.|Through Database Cutoff Date of 04-September-2018 (up to approximately 23 months)|The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥50%.|||Months||95% Confidence Interval|Median
2525257|NCT03850093|Other Pre-specified|Time to 1st Postoperative Rescue Analgesia|time to 1st postoperative rescue analgesia (starting from administration of the studied drug)|on administration of 1st postoperative rescue analgesia||||minutes||Full Range|Median
2525258|NCT03850093|Other Pre-specified|Visual Analogue Scale (VAS) for Postoperative Pain|postoperative visual analogue score (VAS) for pain where 0 is no pain and 10 severe intolerable pain|0n full recovery, 3 and 6 hrs. after recovery||||score on a scale||Full Range|Median
2525259|NCT03850093|Other Pre-specified|Visual Analogue Scale (VAS) for Postoperative Pain|postoperative visual analogue score (VAS) for pain where 0 is no pain and 10 severe intolerable pain which was assessed|1, 3 and 6 hrs. after recovery|||||||
2525260|NCT03850093|Other Pre-specified|Number of Patients Who Recieve Both IV Nitroglycerin and Propranolol During Operative Procedure|need for both IV nitroglycerine and propranolol intraoperatively|at the end of surgery||||Participants|||Count of Participants
2525261|NCT03850093|Other Pre-specified|Number of Patients Who Recieved Intraoperative IV Propranolol During Operative Procedure|the need for additional beta blockers (propranolol)|at the end of surgery||||Participants|||Count of Participants
2525262|NCT03850093|Other Pre-specified|Number of Patients Who Recieved Intraoperative IV Nitroglycerin During Operative Procedure|need for additional intraoperative IV vasodilators (nitroglycerine|at the end of surgery||||Participants|||Count of Participants
2525263|NCT03850093|Other Pre-specified|Surgeon Satisfaction (Categorical)|surgeon satisfaction score where given 5 for very satisfied, 4 for satisfied, 3 for neutral, 2 for dissatisfied and 1 for very dissatisfied then number of satisfied (satisfaction score = 5) and disatisfied (satisfaction score less than 5) surgeons was compared between groups|at the end of surgery||||Participants|||Count of Participants
2525264|NCT03850093|Secondary|Mean Arterial Blood Pressure Change|effect of intervention on the change of mean arterial blood pressure allover study period|were recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgery||||mm Hg||Standard Deviation|Mean
2525265|NCT03850093|Secondary|Heart Rate Change|effect of intervention on the change of heart rate allover study period|were recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgery||||beats/ minute||Standard Deviation|Mean
2525266|NCT03850093|Primary|Blood Loss|total intraoperative blood loss (mL)|at the end of surgery||||mL||Full Range|Median
2525267|NCT03850093|Primary|Changes in Surgical Field Visibility|"according to change in Fromm and Boezaart surgical field category scale ranging from 0 (no bleeding) to 5 (severe bleeding) where: 0 No Bleeding.~Slight bleeding- no blood suctioning required.~Slight bleeding- occasional blood suctioning required.~Slight bleeding- frequent blood suctioning required, operative field is visible for some seconds after evacuation.~Moderate bleeding- frequent blood suctioning required, operative field is only visible immediately after evacuation.~Severe bleeding- constant blood suctioning required, bleeding appears faster than can be removed by suction .Surgery is hardly possible, and sometimes impossible."|scale was assessed by the surgeon every 15 minutes from the start of surgical procedure till the end||||score on a scale||Full Range|Median
2525268|NCT03849300|Secondary|Time to Onset of Claudication|Time to onset of claudication was measured during the 6-minute walking distance test (seconds). A higher value represents a better outcome. Healthy populations can typically walk the entire 6 minutes (360 seconds) without experiencing claudication.|12 weeks||||seconds||Standard Deviation|Mean
2525270|NCT03849300|Secondary|Diastolic Blood Pressure|Blood pressure was measured as millimeters of mercury (mmHg). Higher values represent a worse outcome. Scale range for diastolic blood pressure is approximately 70-79 mmHg for most healthy populations.|12 weeks||||millimeters of mercury||Standard Deviation|Mean
2525271|NCT03849300|Secondary|Medical Outcomes Study Short-Form 36 General Health Survey for Physical Function|The physical function domain score of the Medical Outcomes Study Short-Form 36 General Health Survey was measured. The scale range is from 0 to 100 percent. Higher scores represent a better outcome.|12 weeks||||score in percents||Standard Deviation|Mean
2525272|NCT03849300|Secondary|Lower Body Flexibility|Lower body flexibility was measured using sit-and-reach in centimeters (cm). A higher value represents a better outcome. Scale range is approximately 10-30 cm for healthy populations.|12 weeks||||centimeters||Standard Deviation|Mean
2525273|NCT03849300|Secondary|Lower Body Strength|Lower body strength was measured with leg extension in kilograms (kg). A higher value represents a better outcome. Scale range is approximately 20-120 kg for healthy populations.|12 weeks||||kilograms||Standard Deviation|Mean
2525274|NCT03849300|Secondary|Upper Body Strength|Upper body strength was measured as hand grip strength in kilograms (kg). A higher value represents a better outcome. Scale range is approximately 20-60kg for healthy populations.|12 weeks||||kilograms||Standard Deviation|Mean
2525275|NCT03849300|Secondary|Exercise Tolerance - Walking Capacity|Walking capacity was measured using the 6-minute walk test in meters. A higher value represents a better outcome. Scale range is approximately 400-1000 meters for healthy populations.|12 weeks||||meters||Standard Deviation|Mean
2525276|NCT03849300|Secondary|Cardiorespiratory Capacity|Cardiorespiratory capacity was measured as the volume of maximal oxygen consumption in milliliters per kilogram per minute (VO2max, mL/kg/min). A higher value represents a better outcome. Scale range is approximately 25-60 mL/kg/min for healthy populations.|12 weeks||||milliliters/kilogram/minute of oxygen||Standard Deviation|Mean
2525277|NCT03849300|Secondary|Resting Metabolic Rate|Resting metabolic rate was measured as kilocalories per day. A higher value represents a better outcome. Scale range is approximately 1200-2200 kilocalories per day for healthy populations.|12 weeks||||kilocalories per day||Standard Deviation|Mean
2525278|NCT03849300|Secondary|Systolic Blood Pressure|Blood pressure was measured as millimeters of mercury (mmHg). Higher values represent a worse outcome. Scale range for systolic blood pressure is approximately 110-129mmHg for most healthy populations.|12 weeks||||millimeters of mercury||Standard Deviation|Mean
2525279|NCT03849300|Secondary|Resting Heart Rate|Resting heart rate was measured as beats per minute (bpm). A higher value represents a worse outcome. Acceptable scale range is approximately 60-80 bpm for healthy populations.|12 weeks||||beats per minute||Standard Deviation|Mean
2525280|NCT03849300|Secondary|Body Composition|Body composition was measured using bioelectrical impedance analysis as percent body fat. A higher value represents a worse outcome. Scale range is approximately 10-35% for healthy populations.|12 weeks||||body fat percentage (%)||Standard Deviation|Mean
2525281|NCT03849300|Primary|Peripheral Arterial Stiffness|Peripheral arterial stiffness was estimated as measurement of femoral-to-ankle pulse wave velocity (meters per second). A higher value represents a worse outcome. Scale range is approximately 7.0 - 14.0 meters per second for healthy populations.|12 weeks||||meters per second||Standard Deviation|Mean
2525282|NCT03848910|Primary|To Assess the Subject's Experience Regarding Usage; Wireless Accessories|"The patient will be asked a question Did you use a Wireless accessory during the last 6 weeks. The patient can tick a Yes or No box."|6 weeks after study start||||Participants|||Count of Participants
2525283|NCT03848910|Primary|To Assess the Subject's Experience Regarding Usage; Safety Line|"The patient will be asked a question Did you use a safety line in the last 6 weeks. The patient can tick a Yes or No box."|6 weeks after study start||||Participants|||Count of Participants
2525284|NCT03848910|Primary|To Assess the Subject's Experience Regarding Usage; Softwear Pad|"The patient will be asked a question Did you use a SoftWear Pad in the last 6 weeks. The patient can tick a Yes or No box."|6 weeks after study start||||Participants|||Count of Participants
2525285|NCT03848910|Primary|To Assess the Subject's Experience Regarding Usage; Battery Life Time|"The patient will be asked a question regarding battery life; How often was the battery changed. A free text field is available for answer."|6 weeks after study start||||Participants|||Count of Participants
2525286|NCT03848910|Primary|To Assess the Subject's Experience Regarding Usage; Magnet Choice|Magnet choice will be entered; four boxes are available, 1, 2, 3 and 4, the box with the strength chosen by the patient will be ticked. Magnet strength 1 is the weakest and 4 is the strongest.|6 weeks after study start||||Participants|||Count of Participants
2525287|NCT03848910|Primary|To Assess the Subject's Experience Regarding Comfort|Measure Comfort by a visual analogue scale (VAS) 100 mm at Day 0 regarding the precursor sound processor and after 6 weeks regarding the Investigational device. Subject will be asked to put a line where they find most appropriate where 0 mm represents Not comfortable at all and 100 represents Most comfortable imaginable. The distance will be measured with a ruler and presented as a value between 0 and 100. A higher score reflects higher comfort.|Baseline at visit 1, 6 weeks after study start at visit 3||||units on a scale||Standard Deviation|Mean
2525288|NCT03848910|Primary|To Compare the Subject´s Overall Preference Regarding the Investigational Device and the Precursor Sound Processor|The test subject will be asked a question regarding preferred choice made by selection between Investigational device and the precursor sound processor (comparator). Three boxes can be ticked; Precursor Sound Processor, Investigational Device, No preference.|6 weeks after study start||||Participants|||Count of Participants
2525289|NCT03848910|Primary|Speech in Quiet|To measure Speech in quiet at 50, 65 and 80 dB with the precursor sound processor and the Investigational device. Speech in Quiet presents a list of words in a quiet environment at three different presentations levels, 50, 65 and 80 dB (decibel). The number of correct words perceived at each presentation level are counted and the percentage in relation to the total presented amount of words is calculated. A higher score reflects a higher percentage of correct words perceived, i.e. better hearing in a quiet environment.|Baseline at visit 1, 6 weeks after study start at visit 3||||% correct perceived words||Standard Deviation|Mean
2527549|NCT03563313|Primary|Time in Target Range|The primary outcome is time in target range 70-180 mg/dL measured by CGM in CLC group vs. SAP group.|26 weeks||||percentage of time||Standard Deviation|Mean
2525290|NCT03848910|Primary|Adaptive Speech Recognition in Noise Ratio|To measure Adaptive speech recognition in noise with the precursor sound processor and the Investigational device. Measured as signal to noise ratio The adaptive speech test in noise was conducted using validated lists of phonetically balanced sentences, with speech and noise presented from the front (0 degrees azimuth). The speech is kept constant at 65 dB Sound Pressure Level (SPL) and the noise is adapted in dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and represent a better hearing in a noisy environment.|Baseline at visit 1, 6 weeks after study start at visit 3||||SNR||Standard Deviation|Mean
2525291|NCT03848910|Primary|Audiometric Thresholds in Freefield, Individual Frequencies|To measure threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 Hz with both the precursor sound processor and the Investigational device. The units reported for threshold audiometry are decibels (dB). The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. As such, a lower or more negative score is more desirable and reflects a better ability to hear softer sounds.|6 weeks after study start||||dB||Standard Deviation|Mean
2525292|NCT03848910|Primary|Audiometric Thresholds in Freefield, Pure Tone Average 4 (PTA4)|To measure threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) with both the precursor sound processor and the Investigational device. The units reported for PTA4 are decibels (dB). The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. As such, a lower or more negative score is more desirable and reflects a better ability to hear softer sounds.|Baseline at visit 1, 6 weeks after study start at visit 3||||dB||Standard Deviation|Mean
2525293|NCT03848910|Primary|Self-reported Assessment Regarding Satisfaction and Usability (QUEST Version 2)|"Measuring QUEST (Self-reported assessment regarding satisfaction and usability) using a questionnaire, with the precursor sound processor at Day 0 (Visit 1) and with the Investigational device after 6 weeks (Visit 3). The QUEST form displays the scoring of 8 satisfaction items. The satisfaction items related to the characteristics of the device are: 1) dimensions, 2) weight, 3) adjustments, 4) safety, 5) durability, 6) simplicity of use, 7) comfort and 8) effectiveness. A scale from 1 to 5, where 1 represent not satisfied at all, 2 not very satisfied, 3 more or less satisfied, 4 quiet satisfied and 5 represents very satisfied.~The three most important items of 1) dimensions, 2) weight, 3) adjustments, 4) safety, 5) durability, 6) simplicity of use, 7) comfort and 8) effectiveness were listed by each participant."|Day 0 and after 6 weeks||||Participants|||Count of Participants
2525294|NCT03848910|Primary|Speech, Spatial, and Qualities of Hearing Scale (SSQ)|"Measuring speech, spatial and hearing experiences with the precursor sound processor at Day 0 (Visit 1) and with Investigational device after 6 weeks (Visit 3) with a questionnaire. The Total score summarizes the parameters speech, spatial and hearing. A scale from 0 to 10, where 0 represents can not hear at all, and 10 hear perfectly is used. An increase of a SSQ value reflects an improvement. The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. A positive value indicates an improvement and a negative value an impairment."|Day 0 and after 6 weeks||||units on a scale||Standard Deviation|Mean
2525295|NCT03848910|Primary|Abbreviated Profile of Hearing Aid Benefit (APHAB)|Measuring of subscales Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the precursor sound processor at Day 0 and with the Investigational device after 6 weeks with a questionnaire. All subscales range from 0-100%, total score is the average of all subscales 0-100%, where 0% indicates no problems and 100% indicates always problem. A decrease in the APHAB values indicates an improvement. The change from visit 1 with the precursor sound processor to visit 3 with the Investigational device is presented. A positive value indicates an improvement with the Investigational device, a negative value an impairment.|Day 0 (Visit 1) and after 6 weeks (Visit 3)||||units on a scale||Standard Deviation|Mean
2525296|NCT03848455|Primary|Non-motor Symptom Scale (NMSS)|Scoring based on the patient's own situation in the last month Severity: 1 = mild; 2 = moderate; 3 = severe Frequency: 1 = very little (less than once a week); 2 = often (1 time a week); 3 = frequent (a few times a week); 4 = very frequent (every day or persist)|2 days|Data were not collected.||||||
2525297|NCT03848455|Primary|Unified Parkinson's Disease Rating Scale 3.0（UPDRS 3.0）|"The total score ranges from 0 to 199( minimum score is 0 and maximum scores is 199), in which a lower score denotes a better perception of the patient's.~Scoring the mental, behavioral and emotional, daily living activities, exercise tests, and drug treatment complications associated with UPDRS3.0 in patients with Parkinson's disease;each item 0-4 points, total score 199 points, 0-50 points: limb and body mild dysfunction, posture response normal;51-100 points: mild postural reaction disorder, self-care in daily life, loss of labor force;101-199: obvious postural reaction disorder, loss of daily life and labor force, may need help to get up and confined to wheelchair life;The more severe the symptoms of Parkinson's disease, the higher the score."|2 days|"The Unified Parkinson's Disease Rating Scale 3.0 is just suitable for PD patients,so there are no relative result for the group of healthy controls and Parkinson-plus syndrome group."|||score on a scale||Standard Deviation|Mean
2525298|NCT03848455|Primary|Parkinson's Key Gene|The blood of patients were taken for genetic testing and relative expression levels of the genes(These genes expression relative to a house keeping gene:GAPDH) for PPP2CA, PPP3CB, SYNJ1, NSF were extracted.The method we used is RT-PCR.|3 days||||gene expression relative to GAPDH||Inter-Quartile Range|Median
2525299|NCT03848221|Secondary|Identifying Contact Lens (CL) Participants With Dry Eye Disease (DED), as Measured by the Contact Lens Dry Eye Questionnaire-4 Items (CLDEQ-4) Between Two Weeks and Baseline.|The CLDEQ-4 is a contact lens specific symptoms survey; range = 0-18 with 18 being most symptomatic.|2 Weeks|Generally healthy adults who had a significant CLDEQ-8 score and were contact lens wearers.|||score on a scale||Standard Deviation|Mean
2525318|NCT03836729|Secondary|Period 2: Ctau of GSK3640254|Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 1 and 2 hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7|PK Parameter Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2527632|NCT03557476|Secondary|Malondialdehyde|Plasma levels of malondialdehyde|6 days||||mmol/mL||Standard Deviation|Mean
2525300|NCT03848221|Primary|Difference in Ocular Surface Damage as Measured by the Brien Holden Vision Institute (BHVI Grading Scale) Between Two Weeks and Baseline|The Corneal Staining Scores are measured by the BHVI grading scale. The grading scales are a quick reference to the key signs associated with contact lens related inflammation and infection. Used as a reference tool in the clinic, they provide a guide for determining how much normal ocular appearance has changed in a patient, and can help inform clinical management decisions. The range of the scores are: 0-4 in five regions (total sum score = 20). A lower score indicates a better outcome.|2 Weeks|Generally healthy adults who had a significant CLDEQ-8 score and were contact lens wearers.|||Score on a Scale||Standard Deviation|Mean
2525301|NCT03845933|Primary|Percentage of Adenomas and Hyperplastic Polyps Missed During Initial Right Colon Examination|Lesions detected on the tandem (second) right colon examination are used for the calculation of adenoma and hyperplastic polyp miss rate. Right colon adenoma miss rate (AMR) and right colon hyperplastic polyp miss rate (HPMR) are calculated as the number of adenomas and hyperplastic polyps detected during the second right colon examination divided by the total number of adenoma and hyperplastic polyps detected during both the first and second right colon examinations.|One day||||percentage of all missed polyps||95% Confidence Interval|Mean
2525302|NCT03842683|Secondary|Area Under the Receiver Operating Characteristics Curve of the Hypoglycemia Prediction|"Area under the receiver operating characteristics curve (ROC-AUC) is a measure of the prediction capabilities of a prediction algorithm. Each point of the curve gives a sensitivity and a specificity of the prediction.~Publication reference: https://doi.org/10.1177/1932296819868727"|16 weeks|Nine people from the original study did not have sufficient CGM, insulin, or meal data for the calculation of features.|||probability||95% Confidence Interval|Number
2525303|NCT03842683|Primary|Optimal Time Shift of Continuous Glucose Monitoring Measurements|"Continuous glucose monitoring (CGM) measurements are delayed compared to blood glucose. The CGM signal is time-shifted -1 minute at a time and the mean absolute difference between CGM and blood glucose measurements are calculated at each step. The lowest mean absolute difference depicts the optimal time shift in minutes. The resultant mean absolute relative difference is provided as outcome.~Publication reference: https://doi.org/10.1177/1932296819848721"|16 weeks||||Percentage point change in MARD||90% Confidence Interval|Mean
2525304|NCT03840278|Secondary|Mean Grams of Carbohydrate Per Day to Treat or Prevent Hypoglycemic Events (Reported Daily by Subjects)||Days 1-7||||grams of carbs per day||Standard Deviation|Mean
2525305|NCT03840278|Secondary|Proportion of Time Across Days 2-7 Within the CGM Glucose Range of 70-180 mg/dl||Days 2-7||||percentage of time||Standard Deviation|Mean
2525306|NCT03840278|Secondary|Mean Continuous Glucose Monitor Glucose Concentration|Mean continuous glucose monitor glucose concentration measured days 2-7|Days 2-7||||mg/dl||Standard Deviation|Mean
2525307|NCT03840278|Secondary|Proportion of Time With CGM Glucose < 54 mg/dl||Days 2-7||||proportion of time||Inter-Quartile Range|Median
2525308|NCT03840278|Primary|The Ratio of Cumulative Drug Doses Delivered to Cumulative Drug Doses Attempted for Insulin and Dasiglucagon|Goal for the ratio of cumulative drug doses delivered to cumulative drug doses attempted is between 0.95 and 1.05, inclusive, for insulin and, if applicable, for glucagon.|Days 1-7|Ratio of cumulative insulin doses delivered to cumulative insulin doses attempted was measured in both groups. Ratio of cumulative glucagon doses delivered to cumulative glucagon doses attempted only measured in bihormonal arm.|||ratio of dose delivered:dose attempted||Standard Deviation|Mean
2525309|NCT03840278|Primary|Percentage of Time That Each Drug Channel of the iLet Bionic Pancreas is Available|Goal for the percentage of the time that each drug channel (insulin, and if applicable, glucagon) is available is ≥95%.|Days 1-7|Percent of time that insulin channel available measured in both groups. Percent of time that glucagon channel available measured only in bihormonal group.|||percentage of time||Standard Deviation|Mean
2525310|NCT03840278|Primary|Percentage of Time That Valid CGM Glucose Readings Are Captured by the iLet Bionic Pancreas|Goal for the percentage of time that valid CGM glucose readings are captured by the iLet is ≥80%.|Days 1-7||||percentage of time||Standard Deviation|Mean
2525311|NCT03836729|Secondary|Period 2: Tmax of TFV|Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7|PK Parameter Population|||Hours||Full Range|Median
2525312|NCT03836729|Secondary|Period 1: Tmax of TFV|Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14|PK Parameter Population|||Hours||Full Range|Median
2525313|NCT03836729|Secondary|Period 2: Tmax of FTC|Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7|PK Parameter Population|||Hours||Full Range|Median
2525314|NCT03836729|Secondary|Period 1: Tmax of FTC|Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14|PK Parameter Population|||Hours||Full Range|Median
2525315|NCT03836729|Secondary|Period 2: Tmax of TAF|Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7|PK Parameter Population|||Hours||Full Range|Median
2525316|NCT03836729|Secondary|Period 1: Tmax of TAF|Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14|PK Parameter Population|||Hours||Full Range|Median
2525317|NCT03836729|Secondary|Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254|Blood samples were collected at indicated time-points for analysis of Tmax. PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7|PK Parameter Population|||Hours||Full Range|Median
2527633|NCT03557476|Primary|Low-density Lipoprotein|Plasma levels of low-density lipoprotein|6 days||||mg/dL||Standard Deviation|Mean
2525319|NCT03836729|Secondary|Period 2: Cmax of GSK3640254|Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7|PK Parameter Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525320|NCT03836729|Secondary|Period 2: AUC (0-tau) of GSK3640254|Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 1 and 2hours, 2 hours 30 minutes, 3 and 3 hour 30 minutes, 4 and 4 hour 30 minutes, 5, 6, 8, 12 and 24 hours in Period 2 Day 7|PK Parameter Population|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525321|NCT03836729|Secondary|Period 2: Absolute Values of Blood Pressure|SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.|Baseline and at Days 4, 7, 9, and 10|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Millimeters of mercury||Standard Deviation|Mean
2525322|NCT03836729|Secondary|Period 1: Absolute Values of Blood Pressure|SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.|Baseline and at Days 2, 3, 4, 5 and 7|Safety Population|||Millimeters of mercury||Standard Deviation|Mean
2525323|NCT03836729|Secondary|Period 2: Change From Baseline in Blood Pressure|SBP and DBP was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 4, 7, 9, and 10|Safety Population. Only those participants with data available at the specified time points|||Millimeters of mercury||Standard Deviation|Mean
2525324|NCT03836729|Secondary|Period 1: Change From Baseline in Blood Pressure|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 2, 3, 4, 5 and 7|Safety Population|||Millimeters of mercury||Standard Deviation|Mean
2525325|NCT03836729|Secondary|Period 2: Absolute Values of Respiratory Rate|Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.|Baseline and at Days 4, 7, 9, and 10|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Breaths per minute||Standard Deviation|Mean
2525326|NCT03836729|Secondary|Period 1: Absolute Values of Respiratory Rate|Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.|Baseline and at Days 2, 3, 4, 5 and 7|Safety Population|||Breaths per minute||Standard Deviation|Mean
2525327|NCT03836729|Secondary|Period 2: Change From Baseline in Respiratory Rate|Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 4, 7, 9, and 10|Safety Population. Only those participants with data available at the specified time points|||Breaths per minute||Standard Deviation|Mean
2525328|NCT03836729|Secondary|Period 1: Change From Baseline in Respiratory Rate|Respiratory rate was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 2, 3, 4, 5 and 7|Safety Population|||Breaths per minute||Standard Deviation|Mean
2525329|NCT03836729|Secondary|Period 2: Absolute Values of Pulse Rate|Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.|Baseline and at Days 4, 7, 9, and 10|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Beats per minute||Standard Deviation|Mean
2525330|NCT03836729|Secondary|Period 1: Absolute Values of Pulse Rate|Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.|Baseline and at Days 2, 3, 4, 5 and 7|Safety Population|||Beats per minute||Standard Deviation|Mean
2525331|NCT03836729|Secondary|Period 2: Change From Baseline in Pulse Rate|Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 4, 7, 9, and 10|Safety Population. Only those participants with data available at the specified time points|||Beats per minute||Standard Deviation|Mean
2525332|NCT03836729|Secondary|Period 1: Change From Baseline in Pulse Rate|Pulse rate was assessed in the semi-recumbent position with a completely automated device at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 2, 3, 4, 5 and 7|Safety Population|||Beats per minute||Standard Deviation|Mean
2525333|NCT03836729|Secondary|Period 2: Absolute Values of Temperature|Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.|Baseline and at Days 4, 7, 9, and 10|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Degree Celsius||Standard Deviation|Mean
2525334|NCT03836729|Secondary|Period 1: Absolute Values of Temperature|Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period.|Baseline and at Days 2, 3, 4, 5 and 7|Safety Population|||Degree Celsius||Standard Deviation|Mean
2525335|NCT03836729|Secondary|Period 2: Change From Baseline in Temperature|Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 4, 7, 9, and 10|Safety Population. Only those participants with data available at the specified time points|||Degree Celsius||Standard Deviation|Mean
2525423|NCT03832387|Secondary|Rate of Ventilator Associated Pneumonia|Percentage of participants with lung infection during intensive care unit stay|From start of mechanical ventilation to 2 months||||Participants|||Count of Participants
2525336|NCT03836729|Secondary|Period 1: Change From Baseline in Temperature|Temperature was assessed at indicated time-points. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 2, 3, 4, 5 and 7|Safety Population|||Degree Celsius||Standard Deviation|Mean
2525337|NCT03836729|Secondary|Period 2: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval|Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period.|Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Milliseconds||Standard Deviation|Mean
2525338|NCT03836729|Secondary|Period 1: Absolute Values of ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval|Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interval, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period.|Baseline and at Day 1, 2 and 4 hours post-dose|Safety Population|||Milliseconds||Standard Deviation|Mean
2525339|NCT03836729|Secondary|Period 2: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF Interval, and QTcB Interval|Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Milliseconds||Standard Deviation|Mean
2525340|NCT03836729|Secondary|Period 1: Change From Baseline in ECG Parameters: PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF) Interval, and Bazett QT Correction Formula (QTcB) Interval|Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure PR interval, QRS duration, QT Interal, QTcF Interval and QTcB interval. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Day 1, 2 and 4 hours post-dose|Safety Population|||Milliseconds||Standard Deviation|Mean
2525341|NCT03836729|Secondary|Period 2: Absolute Values of Heart Rate|Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period.|Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Beats per minute||Standard Deviation|Mean
2525342|NCT03836729|Secondary|Period 1: Absolute Values of Heart Rate|Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Day 1, 2 and 4 hours post-dose|Safety Population|||Beats per minute||Standard Deviation|Mean
2525343|NCT03836729|Secondary|Period 2: Change From Baseline in Heart Rate|Twelve-lead ECGs was performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes using an automated ECG machine to measure heart rate. Baseline was defined as Day 1 (Pre-dose) for each Period. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Day 1, 2 and 4 hours post-dose; Day 4, Pre-dose, 2 and 4 hours post-dose; Day 7, Pre-dose, 2 and 4 hours post-dose; Day 9 post-dose|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Beats per minute||Standard Deviation|Mean
2525344|NCT03836729|Secondary|Period 1: Change From Baseline in Heart Rate|Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Day 1, 2 and 4 hours post-dose|Safety Population|||Beats per minute||Standard Deviation|Mean
2525345|NCT03836729|Secondary|Period 2: Absolute Values of Urine Urobilinogen|Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2525346|NCT03836729|Secondary|Period 1: Absolute Values of Urine Urobilinogen|Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1.|Baseline and at Days 7, 14|Safety Population|||Micromoles per liter||Standard Deviation|Mean
2525347|NCT03836729|Secondary|Period 2: Change From Baseline in Urine Urobilinogen|Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2525348|NCT03836729|Secondary|Period 1: Change From Baseline in Urine Urobilinogen|Urine samples were collected at indicated time points for the assessment of urine urobilinogen. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 7, 14|Safety Population|||Micromoles per liter||Standard Deviation|Mean
2525424|NCT03832387|Secondary|Rate of 90 Days Mortality|Mortality at 90 days after randomization|90 days after randomization||||Participants|||Count of Participants
2527858|NCT03546270|Primary|Arterial Stiffness|via Pulse Wave Velocity|20-weeks||||m/s||Standard Deviation|Mean
2525349|NCT03836729|Secondary|Period 2: Absolute Values of pH of Urine|Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Period 1 Day 14 for Period 2.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||pH||Standard Deviation|Mean
2525350|NCT03836729|Secondary|Period 1: Absolute Values of pH of Urine|Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Day -1 for Period 1.|Baseline and at Days 7, 14|Safety Population|||pH||Standard Deviation|Mean
2525351|NCT03836729|Secondary|Period 2: Change From Baseline in pH of Urine|Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||pH||Standard Deviation|Mean
2525352|NCT03836729|Secondary|Period 1: Change From Baseline in Potential of Hydrogen (pH) of Urine|Urine samples were collected at indicated time points for the assessment of Urinary pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 7, 14|Safety Population|||pH||Standard Deviation|Mean
2525353|NCT03836729|Secondary|Period 2: Absolute Values of Specific Gravity of Urine|Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Ratio||Standard Deviation|Mean
2525354|NCT03836729|Secondary|Period 1: Absolute Values of Specific Gravity of Urine|Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1.|Baseline and at Days 7, 14|Safety Population|||Ratio||Standard Deviation|Mean
2525355|NCT03836729|Secondary|Period 2: Change From Baseline in Specific Gravity of Urine|Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Ratio||Standard Deviation|Mean
2525356|NCT03836729|Secondary|Period 1: Change From Baseline in Specific Gravity of Urine|Urine samples were collected at indicated time points for the assessment of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 7, 14|Safety Population|||Ratio||Standard Deviation|Mean
2525357|NCT03836729|Secondary|Period 2: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin|Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Grams per Liter||Standard Deviation|Mean
2525358|NCT03836729|Secondary|Period 1: Absolute Values of Clinical Chemistry Parameter of Total Protein, Albumin and Globulin|Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1.|Baseline and at Days 7, 14|Safety Population|||Grams per Liter||Standard Deviation|Mean
2525359|NCT03836729|Secondary|Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin|Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total protein, albumin and globulin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Grams per Liter||Standard Deviation|Mean
2525360|NCT03836729|Secondary|Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Protein, Albumin and Globulin|Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of of total protein, albumin and globulin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 7, 14|Safety Population|||Grams per Liter||Standard Deviation|Mean
2525425|NCT03832387|Secondary|Rate of Hospital Mortality|Mortality during hospital stay|From hospital admission to 3 months||||Participants|||Count of Participants
2525361|NCT03836729|Secondary|Period 2: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine|Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, creatinine and uric acid. Baseline was defined as Period 1 Day 14 for Period 2.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2525362|NCT03836729|Secondary|Period 1: Absolute Values of Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine|Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1.|Baseline and at Days 7, 14|Safety Population|||Micromoles per liter||Standard Deviation|Mean
2525363|NCT03836729|Secondary|Period 2: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine|Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2525364|NCT03836729|Secondary|Period 1: Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin, Direct Bilirubin, and Creatinine|Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of total bilirubin, direct bilirubin, and creatinine. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 7, 14|Safety Population|||Micromoles per liter||Standard Deviation|Mean
2525365|NCT03836729|Secondary|Period 2: Absolute Values of Chemistry Parameters of Lipase and Amylase|Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Units per Liter||Standard Deviation|Mean
2525366|NCT03836729|Secondary|Period 1: Absolute Values of Chemistry Parameters of Lipase and Amylase|Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1.|Baseline and at Days 7, 14|Safety Population|||Units per Liter||Standard Deviation|Mean
2525367|NCT03836729|Secondary|Period 2: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase|Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Units per Liter||Standard Deviation|Mean
2525368|NCT03836729|Secondary|Period 1: Change From Baseline in Clinical Chemistry Parameter of Lipase and Amylase|Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of lipase and amylase. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 7, 14|Safety Population|||Units per Liter||Standard Deviation|Mean
2525369|NCT03836729|Secondary|Period 2: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK|Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||International units per Liter||Standard Deviation|Mean
2525370|NCT03836729|Secondary|Period 1: Absolute Values of Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK|Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1.|Baseline and at Days 7, 14|Safety Population|||International units per Liter||Standard Deviation|Mean
2525371|NCT03836729|Secondary|Period 2: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST, LDH, GGT, and CK|Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||International units per Liter||Standard Deviation|Mean
2525372|NCT03836729|Secondary|Period 1: Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH), Gamma-glutamyl Transferase (GGT), and Creatine Phosphokinase (CK)|Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter like alkaline phosphatase, ALT, AST, LDH, GGT and CK. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 7, 14|Safety Population|||International units per Liter||Standard Deviation|Mean
2525373|NCT03836729|Secondary|Period 2: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus|Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Millimoles per Liter||Standard Deviation|Mean
2525403|NCT03836729|Primary|Period 1: Ctau of TFV|Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14|PK Parameter Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525374|NCT03836729|Secondary|Period 1: Absolute Values of Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus|Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1.|Baseline and at Days 7, 14|Safety Population|||Millimoles per Liter||Standard Deviation|Mean
2525375|NCT03836729|Secondary|Period 2: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, BUN, CO2, Chloride and Phosphorus|Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Millimoles per Liter||Standard Deviation|Mean
2525376|NCT03836729|Secondary|Period 1: Change From Baseline in Clinical Chemistry Parameter of Glucose, Anion Gap, Cholesterol, Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN), Carbon Dioxide (CO2), Chloride and Phosphorus|Blood samples were collected at indicated time-points for analysis for clinical chemistry parameter of glucose, calcium, potassium, sodium, BUN, anion gap, CO2, chloride and phosphorus. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 7, 14|Safety Population|||Millimoles per Liter||Standard Deviation|Mean
2525377|NCT03836729|Secondary|Period 2: Absolute Values of the Hematology Parameter: Erythrocytes|Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Trillion cells per liter||Standard Deviation|Mean
2525378|NCT03836729|Secondary|Period 1: Absolute Values of the Hematology Parameter: Erythrocytes|Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1.|Baseline and at Days 7, 14|Safety Population|||Trillion cells per liter||Standard Deviation|Mean
2525379|NCT03836729|Secondary|Period 2: Change From Baseline in Hematology Parameter of Erythrocytes|Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Trillion cells per liter||Standard Deviation|Mean
2525380|NCT03836729|Secondary|Period 1: Change From Baseline in Hematology Parameter of Erythrocytes|Blood samples were collected at indicated time-points for analysis for hematology parameter like erythrocytes. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 7, 14|Safety Population|||Trillion cells per liter||Standard Deviation|Mean
2525381|NCT03836729|Secondary|Period 2: Absolute Values of the Hematology Parameter: MCV|Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Femtoliters||Standard Deviation|Mean
2525382|NCT03836729|Secondary|Period 1: Absolute Values of the Hematology Parameter: MCV|Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1.|Baseline and at Days 7, 14|Safety Population|||Femtoliters||Standard Deviation|Mean
2525383|NCT03836729|Secondary|Period 2: Change From Baseline in Hematology Parameter of MCV|Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCV. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Femtoliters||Standard Deviation|Mean
2525384|NCT03836729|Secondary|Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV)|Blood samples were collected at indicated time-points for analysis for hematology parameter like MCV. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 7, 14|Safety Population|||Femtoliters||Standard Deviation|Mean
2525385|NCT03836729|Secondary|Period 2: Absolute Values of the Hematology Parameter: MCH|Blood samples were collected at indicated time-points for analysis of hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Picograms||Standard Deviation|Mean
2525386|NCT03836729|Secondary|Period 1: Absolute Values of the Hematology Parameter: MCH|Blood samples were collected at indicated time-points for analysis for hematology parameter like MCH. Baseline was defined as Day -1 for Period 1.|Baseline and at Days 7, 14|Safety Population|||Picograms||Standard Deviation|Mean
2525387|NCT03836729|Secondary|Period 2: Change From Baseline in Hematology Parameter of MCH|Blood samples were collected at indicated timepoints for analysis for hematology parameter like MCH. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Picograms||Standard Deviation|Mean
2525388|NCT03836729|Secondary|Period 1: Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH)|Blood samples were collected at indicated timepoints for analysis of hematology parameter like MCH. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 7, 14|Safety Population|||Picograms||Standard Deviation|Mean
2525426|NCT03832387|Secondary|Rate of Intensive Care Unit Mortality|Mortality during intensive care unit stay|From intensive care unit admission to 2 months||||Participants|||Count of Participants
2525389|NCT03836729|Secondary|Period 2: Absolute Values of the Hematology Parameter: Hemoglobin|Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2525390|NCT03836729|Secondary|Period 1: Absolute Values of the Hematology Parameter: Hemoglobin|Blood samples were collected at indicated time-points for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1.|Baseline and at Days 7, 14|Safety Population|||Grams per liter||Standard Deviation|Mean
2525391|NCT03836729|Secondary|Period 2: Change From Baseline in Hematology Parameter of Hemoglobin|Blood samples were collected at indicated timepoints for analysis of hematology parameter like hemoglobin. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2525392|NCT03836729|Secondary|Period 1: Change From Baseline in Hematology Parameter of Hemoglobin|Blood samples were collected at indicated timepoints for analysis for hematology parameter like hemoglobin. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 7, 14|Safety Population|||Grams per liter||Standard Deviation|Mean
2525393|NCT03836729|Secondary|Period 2: Absolute Values of the Hematology Parameter: Hematocrit|Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Proportion of red blood cells in blood||Standard Deviation|Mean
2525394|NCT03836729|Secondary|Period 1: Absolute Values of the Hematology Parameter: Hematocrit|Blood samples were collected at indicated time points for analysis for hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1.|Baseline and at Days 7, 14|Safety Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
2525395|NCT03836729|Secondary|Period 2: Change From Baseline in Hematology Parameter of Hematocrit|Blood samples were collected at indicated time-points for analysis for hematology parameter like hematocrit. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Proportion of red blood cells in blood||Standard Deviation|Mean
2525396|NCT03836729|Secondary|Period 1: Change From Baseline in Hematology Parameter of Hematocrit|Blood samples were collected at indicated timepoints for analysis of hematology parameter like hematocrit. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 7, 14|Safety Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
2525397|NCT03836729|Secondary|Period 2: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils|Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Giga cells per liter||Standard Deviation|Mean
2525398|NCT03836729|Secondary|Period 1: Absolute Values of the Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils|Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1.|Baseline and at Days 7, and 14|Safety Population|||Giga cells per liter||Standard Deviation|Mean
2525399|NCT03836729|Secondary|Period 2: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils|Blood samples were collected at indicated timepoints for analysis for hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Period 1 Day 14 for Period 2. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 3, 7, 9|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Giga cells per liter||Standard Deviation|Mean
2525400|NCT03836729|Secondary|Period 1: Change From Baseline in Hematology Parameter of Platelet Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils|Blood samples were collected at indicated timepoints for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as Day -1 for Period 1. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and at Days 7, and 14|Safety Population|||Giga cells per liter||Standard Deviation|Mean
2525401|NCT03836729|Secondary|Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAE)|An adverse events (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before|Up to Day 24|Safety Population included all participants who received at least 1 dose of study medication.|||Participants|||Number
2525402|NCT03836729|Primary|Period 2: Ctau of TFV|Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7|PK Parameter Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2547890|NCT02896595|Secondary|Intraoperative Hemodynamics|systolic blood pressure|Up to 270 minutes|Data was not collected||||||
2525404|NCT03836729|Primary|Period 2: Cmax of TFV|Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7|PK Parameter Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525405|NCT03836729|Primary|Period 1: Cmax of TFV|Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14|PK Parameter Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525406|NCT03836729|Primary|Period 2: AUC (0-tau) of TFV|Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7|PK Parameter Population|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525407|NCT03836729|Primary|Period 1: AUC (0-tau) of Tenofovir (TFV)|Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14|PK Parameter Population|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525408|NCT03836729|Primary|Period 2: Ctau of FTC|Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7|PK Parameter Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525409|NCT03836729|Primary|Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of FTC|Blood samples were collected at indicated time-points for analysis of Ctau. PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14|PK Parameter Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525410|NCT03836729|Primary|Period 2:Cmax of FTC|Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7|PK Parameter Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525411|NCT03836729|Primary|Period 1:Cmax of FTC|Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14|PK Parameter Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525412|NCT03836729|Primary|Period 2: AUC (0-tau) of FTC|Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7|PK Parameter Population|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525413|NCT03836729|Primary|Period 1: AUC (0-tau) of FTC|Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14|PK Parameter Population|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525414|NCT03836729|Primary|Period 2: Cmax of TAF|Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7|PK Parameter Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525415|NCT03836729|Primary|Period 1: Maximum Observed Concentration (Cmax) of TAF|Blood samples were collected at indicated time-points for analysis of Cmax. PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14|PK Parameter Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525416|NCT03836729|Primary|Period 2: AUC (0-tau) of TAF|Blood samples were collected at indicated time-points for analysis of AUC (0-tau). PK parameters were calculated by standard non-compartmental analysis.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 2 Day 7|PK Parameter Population|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525417|NCT03836729|Primary|Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing Interval at Steady State (AUC [0-tau]) of TAF|Blood samples were collected at indicated time-points for analysis of AUC (0-tau). Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Parameter Population included all participants who underwent plasma PK sampling and had evaluable PK parameters estimated.|Pre-dose, 15, 30, 45 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 4, 5, 6, 8, 12 and 24 hours in Period 1 Day 14|PK Parameter Population|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525418|NCT03836664|Secondary|Number of Participants Satisfied With Intervention|"Measured by patient-reported satisfaction questionnaire. Satisfaction level was looked at as satisfactory and very satisfactory compared to neutral and unsatisfied."|8 weeks|All participants|||Participants|||Count of Participants
2525419|NCT03836664|Secondary|Adverse Reaction From Using Timolol Eye Drops|Measured by number of adverse events experienced by the participants from the intervention. Each adverse event was counted as one.|8 weeks|total number of adverse events in each group|||events|||Number
2525420|NCT03836664|Primary|Headache Severity|Measure of the change in severity using visual analogue pain scale ranging from 0-10 with zero being no pain and ten being worst pain. Scale will be completed after each migraine episode over course of participation in study, up to 8 weeks.|Headache/ pain severity at onset and at 120 minutes post intervention use|All participants|||score on a scale||95% Confidence Interval|Mean
2525421|NCT03832387|Secondary|Rate of Bacteremia|Percentage of participants with blood infection during intensive care unit stay|From intensive care unit admission to 2 months||||Participants|||Count of Participants
2525428|NCT03832387|Secondary|Duration of Non-invasive Mechanical Ventilation or Oxygen Therapy|Duration of non-invasive mechanical ventilation or oxygen therapy after randomization until success or failure.|From randomization to one week||||HOURS||Inter-Quartile Range|Median
2525429|NCT03832387|Secondary|Hospital Length of Stay|Duration of stay at hospital|From hospital admission to 3 months||||days||Inter-Quartile Range|Median
2525430|NCT03832387|Secondary|Intensive Care Unit Length of Stay|Duration of stay at intensive care unit|From intensive care unit admission to 2 months||||days||Inter-Quartile Range|Median
2525431|NCT03832387|Secondary|Rate of Tracheotomy|Need for tracheotomy after reintubation, because of prolongation of mechanical ventilation|from randomization to 3 weeks||||Participants|||Count of Participants
2525432|NCT03832387|Primary|Rate of Intubation|Need for intubation after assignment to non-invasive mechanical ventilation or oxygen therapy|from randomization to 1 week||||participants|||Number
2525433|NCT03832322|Primary|Percentage of Overall Detected Adenomas Missed During the First Proximal-Colon Colonoscopy|Proximal-colon (cecum, A-colon, hepatic flexure, T-colon) adenomas detected on the second-pass examination were used for the calculation of adenoma miss. Adenoma miss rate was calculated as the number of adenomas missed in the first colonoscopy divided by the total number of adenomas detected during both the first and second colonoscopies.|During procedure, approximately 1.5 hours||||percentage of detected adenomas||95% Confidence Interval|Mean
2525434|NCT03832322|Primary|Percentage of Overall Detected Adenomas Missed During the First Right-Colon Colonoscopy|Right-colon (cecum, A-colon, hepatic flexure) adenomas detected on the second-pass examination were used for the calculation of adenoma miss. Adenoma miss rate was calculated as the number of adenomas missed in the first colonoscopy divided by the total number of adenomas detected during both the first and second colonoscopies.|During procedure, approximately 1.5 hours||||percentage of detected adenomas||95% Confidence Interval|Mean
2525435|NCT03831451|Primary|Change in Behavioral Intent to Call 911|Change in Behavioral intent to call 911 using a self-administered survey. The survey is the Stroke Action test which was modified based on community input. Scores range from 0-12 for stroke. A higher score means greater stroke behavioral intent to call 911 for a stroke while a low score means lower behavioral intent to call 911 for a stroke.|Immediately (up to 10 minutes) before the brief intervention and then immediately (up to 10 minutes) after completing the brief intervention|Mean changes from pre-intervention to post-intervention|||units on a scale||Standard Error|Mean
2525436|NCT03831282|Primary|Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation|Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the root mean square (RMS) error value. In order to obtain the RMS value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for each sample, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value.|up to 12 hours|Subject 5:Removed per ISO standard for SpO2 equal to 100. Subject 12: No data collected|||percent of oxygen saturated hemoglobin|||Number
2525437|NCT03830307|Secondary|Pain Score With Movement|Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.|120 hours post-operatively|Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled|||score on a scale||Full Range|Median
2525438|NCT03830307|Secondary|Pain Score With Movement|Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.|96 hours post-operatively|Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled|||score on a scale||Full Range|Median
2525439|NCT03830307|Secondary|Pain Score With Movement|Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.|72 hours post-operatively|Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled|||score on a scale||Full Range|Median
2525440|NCT03830307|Secondary|Pain Score With Movement|Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.|48 hours post-operatively|Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled|||score on a scale||Full Range|Median
2525441|NCT03830307|Secondary|Pain Score With Movement|Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.|24 hours post-operatively|Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled|||score on a scale||Full Range|Median
2525442|NCT03830307|Secondary|Pain Score at Rest|=Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.|120 hours post-operatively|Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled|||score on a scale||Full Range|Median
2525443|NCT03830307|Secondary|Pain Score at Rest|Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.|96 hours post-operatively|Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled|||score on a scale||Full Range|Median
2525444|NCT03830307|Secondary|Pain Score at Rest|Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.|72 hours post-operatively|Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled|||score on a scale||Full Range|Median
2525499|NCT03817775|Secondary|Effect on Physiological Parameters: Heart Rate|Heart rate at Baseline which corresponds to 10 minutes before the beginning of the procedure.|10 minutes prior to the beginning of the procedure.||||beat/min||Standard Deviation|Mean
2525445|NCT03830307|Secondary|Pain Score at Rest|Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.|48 hours post-operatively|Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled|||score on a scale||Full Range|Median
2525446|NCT03830307|Secondary|Pain Score at Rest|Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.|24 hours post-operatively|Some participants were unavailable to give a pain score on some days, hence the discrepancy of the number analyzed versus overall enrolled|||score on a scale||Full Range|Median
2525447|NCT03830307|Secondary|Level of Comfort Wearing NSS-2 Bridge Device|Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.|120 hours post-operatively|Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled|||score on a scale||Full Range|Median
2525448|NCT03830307|Secondary|Level of Comfort Wearing NSS-2 Bridge Device|Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.|96 hours post-operatively|Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled|||score on a scale||Full Range|Median
2525449|NCT03830307|Secondary|Level of Comfort Wearing NSS-2 Bridge Device|Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.|72 hours post-operatively|Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled|||score on a scale||Full Range|Median
2525450|NCT03830307|Secondary|Level of Comfort Wearing NSS-2 Bridge Device|Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.|48 hours post-operatively|Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled|||score on a scale||Full Range|Median
2525451|NCT03830307|Secondary|Level of Comfort Wearing NSS-2 Bridge Device|Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.|24 hours post-operatively|Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled|||score on a scale||Full Range|Median
2525452|NCT03830307|Secondary|Efficacy of NSS-2 Bridge Device: Opioid Consumption|Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative opioid consumption in opioid-naïve patients undergoing elective cesarean section surgery.|Day of Surgery through 90 days post-operative|90 follow-up of opioid medication was not collected in intervention group||||||
2525453|NCT03830307|Secondary|Number of Participants With Post-operative Complications|Investigate the incidence of post-operative complications for patients receiving the NSS-2-Bridge device.|Day of Surgery through 90 days post-operative||||Participants|||Count of Participants
2525454|NCT03830307|Primary|Opioid Consumption|Investigate the efficacy of the NSS-2 BRIDGE device in reducing perioperative opioid consumption in opioid-naïve patients undergoing elective cesarean section surgery using the current post-operative standard of care.|Day of surgery through post-operative day 5||||milligrams of oxycodone||Full Range|Mean
2525455|NCT03828149|Primary|Safety (Evaluation of Adverse Events)|All randomized participants who received at least one spray of study treatment in either nare were included in the safety analysis.|Days 1-9||||Participants|||Count of Participants
2525456|NCT03825393|Secondary|Beck Anxiety Inventory|"Beck Anxiety Inventory is a short, easily applied and graded, 21-item questionnaire to evaluate the severity of patients' anxiety. Total points vary from 0 to 63 (0-9 points: normal; 10-18 points: slight to moderate anxiety; 19-29 points: moderate to severe anxiety and 30-63 points: very severe anxiety).~minimum 0 maximum 63 points higher scores mean worse outcome"|1 year|100 This inventory applied only Firomyalgia syndrome group|||score on a questionnarie||Standard Deviation|Mean
2525457|NCT03825393|Secondary|Beck Depression Inventory|"Beck Depression Inventory (BDI) is a 21-item questionnaire evaluating the presence and severity of depression. Higher points mean heavier depression (0-9 points: minimum depression; 10-18 points: slight depression; 19-29 points: moderate depression; 30-63 points: severe depression).~minimum 0 maximum 63 points higher scores mean worse outcome."|1 year|100 This questionnarie applied only Firomyalgia syndrome group|||score on a questionnarie||Standard Deviation|Mean
2525458|NCT03825393|Secondary|Fibromyalgia Impact Questionnarie Scores|"Fibromyalgia Impact Questionnaire (FIQ) is a 10-item evaluation tool developed to measure status, prognosis and outcomes of FMS patients. Total points vary from 0 to 100. Higher points show the effect of FMS on functionality.~mimimum score 0 maximum score 100 higher scores shows poor functionality."|1 year|100 This questionnarie applied only Firomyalgia syndrome group|||score on a questionnarie||Standard Deviation|Mean
2525459|NCT03825393|Primary|Ferritin Level|Iron deficiency marker|1 year|200|||ng/ml||Inter-Quartile Range|Median
2525460|NCT03825393|Primary|Pitsburgh Sleep Quality Index|"Pittsburgh Sleep Quality Index (PSQI) is an 18-item questionnaire measuring sleep quality and disorders in a time period of one month. PSQI measures subjective sleep quality, duration and latency of sleep, sleep disorders, habitual sleep efficiency, daytime dysfunction and use of medication for sleeping. PSQI distinguishes poor sleep from good sleep.~minimum score 1 maximum score 9~≥5 total points in PSQI mean poor sleep. <5 total points in PSQI mean good sleep."|1 year|100 This index applied only Firomyalgia syndrome group|||score on a questionnarie||Standard Deviation|Mean
2525475|NCT03822078|Secondary|Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)||Baseline and day 2, 3, 5, 8, 15, 29, 57, 85, 99, 113 (for all dose cohorts), 141, 169 (0.3, 1.0, and 3.0 mg/kg cohorts only), 197, 225, 253, 281, and 309 (1.0 and 3.0 mg/kg cohorts only)|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2527634|NCT03557476|Primary|High-density Lipoprotein|Plasma levels of high-density lipoprotein|6 days||||mg/dL||Standard Deviation|Mean
2525461|NCT03824912|Secondary|Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)|"Mycological Cure: To be considered a mycological cure the patient must have a negative Potassium hydroxide (KOH) test and a negative fungal culture.~Mycological Failure: A patient will be considered a Mycological Failure if the patient's KOH test is positive or the patient's fungal culture is positive."|Two weeks after the end of treatment (Day 56 ± 4) (Superiority)|The MITT population was used for the analysis. One patient had an inconclusive result for the fungal culture at Visit 3 and was excluded from the analysis of the secondary endpoint for the mycological cure. Patient was a clinical failure and was included in the primary analysis.|||Participants|||Count of Participants
2525462|NCT03824912|Secondary|Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)|"Clinical Cure: To be considered a clinical cure the patient's total severity score must be ≤ 2 with no individual severity score > 1.~Clinical Failure: A patient will be considered a Clinical Failure if the patient's total severity score is > 2 or any individual score is > 1.~Local Signs and Symptoms The most severely affected area will be identified as the target lesion at the baseline visit and will be used for the assessments at Day 42 and Day 56 visits.~The Clinical Signs and Symptoms of tinea pedis will be rated by the Investigator as none, mild, moderate or severe using the following standardized rating scale.~0 = None (complete absence of any sign or symptom)~= Mild (Slight)~= Moderate (Definitely Present)~= Severe (Marked, Intense)~The following signs and symptoms will be rated at each visit:~Signs: Fissuring/cracking, erythema, maceration, and scaling~Symptoms: Pruritus and burning/stinging"|Two weeks after the end of treatment (Day 56 ± 4) (Superiority)|The MITT population was used for analysis.|||Participants|||Count of Participants
2525463|NCT03824912|Secondary|Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Equivalence: Per-Protocol Population)|"Mycological Cure: To be considered a mycological cure the patient must have a negative Potassium hydroxide (KOH) test and a negative fungal culture.~Mycological Failure: A patient will be considered a Mycological Failure if the patient's KOH test is positive or the patient's fungal culture is positive."|Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)|The PP population was used for this analysis to determine equivalence between the Test and Reference groups only. One patient had an inconclusive result for the fungal culture at Visit 3 and was excluded from the analysis of the secondary endpoint for the mycological cure. Patient was a clinical failure and was included in the primary analysis.|||Participants|||Count of Participants
2525464|NCT03824912|Secondary|Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Equivalence: Per-Protocol Population)|"Clinical Cure: To be considered a clinical cure the patient's total severity score must be ≤ 2 with no individual severity score > 1.~Clinical Failure: A patient will be considered a Clinical Failure if the patient's total severity score is > 2 or any individual score is > 1.~Local Signs and Symptoms The most severely affected area will be identified as the target lesion at the baseline visit and will be used for the assessments at Day 42 and Day 56 visits.~The Clinical Signs and Symptoms of tinea pedis will be rated by the Investigator as none, mild, moderate or severe using the following standardized rating scale.~0 = None (complete absence of any sign or symptom)~= Mild (Slight)~= Moderate (Definitely Present)~= Severe (Marked, Intense)~The following signs and symptoms will be rated at each visit:~Signs: Fissuring/cracking, erythema, maceration, and scaling~Symptoms: Pruritus and burning/stinging"|Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)|The Per-Protocol population was used for this analysis to determine equivalence between the Test and Reference groups only. To determine equivalence, only the test and reference treatment arms are analyzed.|||Participants|||Count of Participants
2525465|NCT03824912|Primary|Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population)|"Superiority: modified Intent-to-Treat Population Therapeutic Cure: To be considered a Therapeutic Cure, the patient must have both Clinical and Mycological Cure of tinea pedis.~Therapeutic Failure: A patient will be considered a Therapeutic Failure if:~the patient is a Clinical or Mycological Failure~the patient was considered to have an insufficient therapeutic response~the patient used topical drug therapy for irritation or pruritus on the feet after the treatment phase of the study"|Two weeks after the end of treatment (Day 56 ± 4) (Superiority)|The MITT Population was used for analysis.|||Participants|||Count of Participants
2525466|NCT03824912|Primary|Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Equivalence: Per-Protocol Population)|"Equivalence: Per-Protocol Population Therapeutic Cure: To be considered a Therapeutic Cure, the patient must have both Clinical and Mycological Cure of tinea pedis.~Therapeutic Failure: A patient will be considered a Therapeutic Failure if:~the patient is a Clinical or Mycological Failure~the patient was considered to have an insufficient therapeutic response~the patient used topical drug therapy for irritation or pruritus on the feet after the treatment phase of the study"|Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)|The Per-Protocol population was used for this analysis to determine equivalence between the Test and Reference groups only. To determine equivalence, only the test and reference treatment arms are analyzed.|||Participants|||Count of Participants
2525467|NCT03822884|Secondary|Adverse Events|Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0|120hr||||Participants|||Count of Participants
2525468|NCT03822884|Secondary|ADAs|Number of patients with antidrug antibodies after 3 months. Anti-erythropoietin antibodies screening was done using immunoprecipitation on the sample collected prior to the first dose of the first phase of the trial and on the 504-hour sample of the third phase|120hr||||Participants|||Count of Participants
2525469|NCT03822884|Secondary|Reticulocyte Response: AUC 0-120h||120hr||||mUI*h/mL||Standard Deviation|Mean
2525470|NCT03822884|Secondary|Reticulocyte Response: Cmax|Reticulocyte count by flow cytometry, as a surrogate marker of the pharmacodynamics of erythropoietin. Maximum reticulocyte concentration achieved.|120hr||||mUI / ml||Standard Deviation|Mean
2525471|NCT03822884|Primary|Tmax|Tmax: time to the maximum serum concentration of epoetin alfa|120hr||||h||Standard Deviation|Mean
2525472|NCT03822884|Primary|Cmax|Cmax: maximum serum concentration of epoetin alfa.|120hr||||mUI / ml||Standard Deviation|Mean
2525473|NCT03822884|Primary|AUC0-∞|AUC0-∞: Area under the serum concentration curve resulting from extrapolation from time 0 to time ∞.|120hr||||mUI*h/mL||Standard Deviation|Mean
2525476|NCT03822078|Secondary|Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)||Baseline and day 8, 15, 22, 29, 43, 57, 71, 85, 99, 113 (for all dose cohorts), 141, 169 (0.3, 1.0, and 3.0 mg/kg cohorts only), 197, 225, and 253, 281, and 309 (1.0 and 3.0 mg/kg cohorts only)|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2525477|NCT03822078|Secondary|Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)||Baseline and day 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113 (for all dose cohorts), 141, 169 (0.3, 1.0, and 3.0 mg/kg cohorts only), 197, 225, 253, 281, and 309 (1.0 and 3.0 mg/kg cohorts only).|Treated participants with available data at each time point|||percent change||Standard Error|Mean
2525478|NCT03822078|Secondary|Mean Residence Time (MRT) From Time 0 to Time of Last Quantifiable Serum Concentration||Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts|All participants who received denosumab|||days||Standard Deviation|Mean
2525479|NCT03822078|Secondary|Apparent Clearance (CL/F) of Denosumab||Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts|All participants who received denosumab|||mL/day/kg||Standard Deviation|Mean
2525480|NCT03822078|Secondary|Time to Maximum Observed Concentration (Tmax) of Denosumab||Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts|All participants who received denosumab|||days||Full Range|Median
2525481|NCT03822078|Secondary|Maximum Observed Concentration of Denosumab (Cmax)||Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts||||ng/mL||Standard Deviation|Mean
2525482|NCT03822078|Secondary|Area Under the Serum Concentration Time Curve From Time 0 to Time of Last Quantifiable Serum Concentration (AUC0-t) of Denosumab||Day 1 predose and 5 minutes, 1, 4, 8, 12, 24, hours, days 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, also days 141 and 169 for participants in the 0.3, 1.0, or 3.0 mg/kg cohorts and days 197, 225, and 253 for the 1.0 or 3.0 mg/kg dose cohorts|All participants who received denosumab|||μg*day/mL||Standard Deviation|Mean
2525483|NCT03822078|Primary|Number of Participants With Adverse Events||From day 1 up to 4 months for participants assigned to the 0.03 or 0.1 mg/kg dose cohorts, up to 6 months for participants assigned to the 0.3 mg/kg dose cohort and for up to 9 months for participants assigned to the 1.0 or 3.0 mg/kg dose cohorts|All treated participants|||Participants|||Count of Participants
2525484|NCT03820544|Primary|Intraoperative Estimated Blood Loss|Group comparisons will be performed using two sample t-tests or Wilcoxon rank sum tests.|At time of surgery|Due to the low enrollment number to this study, statistical analysis was not conducted due to insufficient data collected to run analyses.||||||
2525485|NCT03820544|Primary|Complication Rates of Grade III or Higher|The risk difference will be calculated (stent minus control) with a one-sided 95% confidence interval.|At 30 days post-surgery|Due to the low enrollment number to this study, statistical analysis was not conducted due to insufficient data collected to run analyses.||||||
2525486|NCT03819491|Primary|"Analysis of Pharmacokinetic Property Tmax"|"- Tmax: ≥3~Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided.~Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit."|from day-7 to day 28||||hours||95% Confidence Interval|Mean
2525487|NCT03819491|Primary|"Analysis of Pharmacokinetic Property Cmax"|"- Cmax: ≥0,8~Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided.~Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit."|from day-7 to day 28||||microg/l||95% Confidence Interval|Mean
2525488|NCT03819491|Primary|"Analysis of Pharmacokinetic Property Area Under the Curve"|"- Area under the curve (microg/ml x h): ≥5~Due to the explorative aim of the study, descriptive statistics and confidence intervals at 95% level will be provided.~Data were collected at 1, 2, 4, 8 and 12 hours after intake on the single dose period (day -7) and at each following ambulatory visit."|from day-7 to day 28||||microg/l*days||95% Confidence Interval|Mean
2525489|NCT03817879|Other Pre-specified|Patient Reported Post Operative Outcomes|Qualitative assessment (face-validated and testet during pilot test) using a questionnaire registrering postoperative outcomes (Yes/No) and degree of postoperative outcomes (mild/moderate/severe)|Within 48 hours after the procedure|||||||
2525490|NCT03817879|Other Pre-specified|Obtain User Perspective of the Device (VivaSight Double Lumen Tube or Conventional Double Lumen Tube) Used During Procedure.|Qualitative assessment (face-validated and testet during pilot test) using a five-point scale (1: very easy/very good, 3: acceptable, 5: very difficult/very poor)|During procedure, up to 4 hours|||||||
2525491|NCT03817879|Secondary|Cost Per Procedure||An average of 1 year|||||||
2525492|NCT03817879|Secondary|Number of Times Repositioning of the Tube Was Prevented||During procedure, up to 4 hours|||||||
2525493|NCT03817879|Secondary|Number of Time the Tube Was Repositioned||During procedure, up to 4 hours|||||||
2525494|NCT03817879|Secondary|Number of Intubation Attempts||During procedure, up to 4 hours|||||||
2525495|NCT03817879|Secondary|Intubation Time||During procedure, up to 4 hours|||||||
2525496|NCT03817879|Primary|Number of Times Bronchoscope is Used||During procedure, up to 4 hours||||Reported uses of bronchoscopes||Standard Deviation|Mean
2525497|NCT03817775|Secondary|Effect on Physiological Parameters: Mean Arterial Blood Pressure|Mean arterial blood pressure at Baseline which corresponds to 10 minutes before the beginning of the procedure.|10 minutes prior to the beginning of the procedure.|Two patients in control group and 1 in music therapy had missing data.|||mmHg||Standard Deviation|Mean
2525498|NCT03817775|Secondary|Effect on Physiological Parameters: SpO2%|SpO2 at Baseline which corresponds to 10 minutes before the beginning of the procedure..|10 minutes prior to the beginning of the procedure.||||Percentage of O2 saturation in blood||Standard Deviation|Mean
2525500|NCT03817775|Secondary|Effect on Physiological Parameters: BIS|"Bispectral index (BIS) score at baseline which corresponds to 10 minutes before the beginning of the procedure.~The BIS monitor provides a single dimensionless number which ranges from 0 (equivalent to EEG silence) to 100. Higher is the score, better it is."|10 minutes prior to the beginning of the procedure|2 missing data in control group|||Score||Standard Deviation|Mean
2525501|NCT03817775|Secondary|Satisfaction of the Patient|Satisfaction was measured using a scale from 0 to 5, with a higher score for a high satisfaction.|Right after the end of the procedure in the recovery room.|Two patients in control group and 3 patients in music therapy group had missing data on satisfaction endpoint.|||Score||Standard Deviation|Mean
2525502|NCT03817775|Secondary|Anxiety Score (NRS)|Anxiety score was measured using the Numeric Rating Scale (NRS). This scale ranged from 0 (no anxiety) to 10 (very high anxiety), and collected the maximum anxiety the patient had during the procedure. This was collected right after the end of the procedure in the recovery room.|From 0 up to 45 minutes.||||score on a scale||Standard Deviation|Mean
2525503|NCT03817775|Secondary|Pain Score|Pain score was measured using the Visual Analog Scale (VAS). This scale ranged from 0 (no pain) to 10 (very high pain), and collected the maximum pain the patient had during the procedure. This was collected right after the end of the procedure in the recovery room.|From 0 up to 45 minutes.|Three patients in control group and 3 patients in music therapy group had missing data on VAS pain score.|||score on a scale||Standard Deviation|Mean
2525504|NCT03817775|Primary|Dose Use of Sufentanil Medication (ug)|The consumption in Sufentanil medication was reported during the coronary angioplasty. Dose was in ug.|Between 10 minutes prior to the beginning of the procedure up to 45 minutes.||||ug||Standard Deviation|Mean
2525505|NCT03817775|Primary|Dose Use of Propofol Medication (mg)|The consumption in Propofol medication was reported during the coronary angioplasty. Dose was in mg.|Between 10 minutes prior to the beginning of the procedure up to 45 minutes.|One patient in control group and 2 patients in music therapy group had missing data on Propofol medication.|||mg||Standard Deviation|Mean
2525506|NCT03817775|Primary|Dose Use of Midazolam Medication (mg)|The consumption in Midazolam medication was reported during the coronary angioplasty. Dose was in mg.|Between 10 minutes prior to the beginning of the procedure up to 45 minutes.||||mg||Standard Deviation|Mean
2525507|NCT03816696|Secondary|Period 3: T1/2 of Dolutegravir for Dolutegravir + GSK3640254 Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2525508|NCT03816696|Secondary|Period 1: T1/2 of Dolutegravir for Dolutegravir Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2525509|NCT03816696|Secondary|Period 3: Tmax of Dolutegravir for Dolutegravir + GSK3640254 Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Hours||Full Range|Median
2525510|NCT03816696|Secondary|Period 1: Tmax of Dolutegravir for Dolutegravir Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Hours||Full Range|Median
2525511|NCT03816696|Secondary|Period 3: T1/2 of GSK3640254 for Dolutegravir + GSK3640254 Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2525512|NCT03816696|Secondary|Period 2: Apparent Terminal Phase Half-life (T1/2) of GSK3640254 for GSK3640254 Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Data could not be determined due to limited sampling points after final dosing (during elimination phase). An accurate determination of GSK3640254 half-life would require sampling up to 3 times half-life (3 * approximately 24 hours). However sampling in Period 2 was performed up to only 24 hours post-dose.|Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2525513|NCT03816696|Secondary|Period 3: Tmax of GSK3640254 for Dolutegravir + GSK3640254 Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Hours||Full Range|Median
2525514|NCT03816696|Secondary|Period 2: Time of Maximum Observed Concentration (Tmax) of GSK3640254 for GSK3640254 Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Hours||Full Range|Median
2525515|NCT03816696|Secondary|Period 3: Absolute Values for Body Temperature|Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.|Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11|Safety Population.|||Degrees Celsius||Standard Deviation|Mean
2525516|NCT03816696|Secondary|Period 2: Absolute Values for Body Temperature|Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.|Days 2, 3, 4, 5, 6 and 7|Safety Population.|||Degrees Celsius||Standard Deviation|Mean
2525517|NCT03816696|Secondary|Period 1: Absolute Values for Body Temperature|Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.|Days 2, 3, 4 and 5|Safety Population.|||Degrees Celsius||Standard Deviation|Mean
2525518|NCT03816696|Secondary|Period 3: Absolute Values for Respiratory Rate|Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.|Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11|Safety Population.|||Breaths per minute||Standard Deviation|Mean
2525519|NCT03816696|Secondary|Period 2: Absolute Values for Respiratory Rate|Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.|Days 2, 3, 4, 5, 6 and 7|Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||Breaths per minute||Standard Deviation|Mean
2525520|NCT03816696|Secondary|Period 1: Absolute Values for Respiratory Rate|Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions.|Days 2, 3, 4 and 5|Safety Population.|||Breaths per minute||Standard Deviation|Mean
2525521|NCT03816696|Secondary|Period 3: Absolute Values for Pulse Rate|Pulse rate was measured in the semi-recumbent position with a completely automated device.|Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11|Safety Population.|||Beats per minute||Standard Deviation|Mean
2525522|NCT03816696|Secondary|Period 2: Absolute Values for Pulse Rate|Pulse rate was measured in the semi-recumbent position with a completely automated device.|Days 2, 3, 4, 5, 6 and 7|Safety Population.|||Beats per minute||Standard Deviation|Mean
2525523|NCT03816696|Secondary|Period 1: Absolute Values for Pulse Rate|Pulse rate was measured in the semi-recumbent position with a completely automated device.|Days 2, 3, 4 and 5|Safety Population.|||Beats per minute||Standard Deviation|Mean
2525524|NCT03816696|Secondary|Period 3: Absolute Values for SBP and DBP|SBP and DBP were measured in the semi-recumbent position with a completely automated device.|Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11|Safety Population.|||Millimeters of mercury||Standard Deviation|Mean
2525525|NCT03816696|Secondary|Period 2: Absolute Values for SBP and DBP|SBP and DBP were measured in the semi-recumbent position with a completely automated device.|Days 2, 3, 4, 5, 6 and 7|Safety Population.|||Millimeters of mercury||Standard Deviation|Mean
2525526|NCT03816696|Secondary|Period 1: Absolute Values for SBP and DBP|SBP and DBP were measured in the semi-recumbent position with a completely automated device.|Days 2, 3, 4 and 5|Safety Population.|||Millimeters of mercury||Standard Deviation|Mean
2525527|NCT03816696|Secondary|Period 3: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB|Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.|Day 1: 2 hours, 4 hours; Days 4, 5 and 7: Pre-dose, 2 hours and 4 hours; Day 10|Safety Population.|||Milliseconds||Standard Deviation|Mean
2525528|NCT03816696|Secondary|Period 2: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB|Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.|Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours|Safety Population.|||Milliseconds||Standard Deviation|Mean
2525529|NCT03816696|Secondary|Period 1: Absolute Values for ECG Parameters: PR Interval, QRS Duration, QT Interval, QTcF, QTcB|Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes.|Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours|Safety Population.|||Milliseconds||Standard Deviation|Mean
2525530|NCT03816696|Secondary|Period 3: Absolute Values for Urinalysis Parameter: pH|Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Days 4, 7 and 10|Safety Population.|||pH||Standard Deviation|Mean
2525531|NCT03816696|Secondary|Period 2: Absolute Values for Urinalysis Parameter: pH|Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Day 7|Safety Population.|||pH||Standard Deviation|Mean
2525532|NCT03816696|Secondary|Period 1: Absolute Values for Urinalysis Parameter: pH|Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Day 9|Safety Population.|||pH||Standard Deviation|Mean
2525533|NCT03816696|Secondary|Period 3: Absolute Values for Urinalysis Parameter: Urobilinogen|Urine samples were collected to analyze the urinalysis parameter: urobilinogen.|Days 4, 7 and 10|Safety Population.|||Micromoles per liter||Standard Deviation|Mean
2525534|NCT03816696|Secondary|Period 2: Absolute Values for Urinalysis Parameter: Urobilinogen|Urine samples were collected to analyze the urinalysis parameter: urobilinogen.|Day 7|Safety Population.|||Micromoles per liter||Standard Deviation|Mean
2525535|NCT03816696|Secondary|Period 1: Absolute Values for Urinalysis Parameter: Urobilinogen|Urine samples were collected to analyze the urinalysis parameter: urobilinogen.|Day 9|Safety Population.|||Micromoles per liter||Standard Deviation|Mean
2525536|NCT03816696|Secondary|Period 3: Absolute Values for Urinalysis Parameter: Specific Gravity|Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine.|Days 4, 7 and 10|Safety Population.|||Ratio||Standard Deviation|Mean
2525537|NCT03816696|Secondary|Period 2: Absolute Values for Urinalysis Parameter: Specific Gravity|Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine.|Day 7|Safety Population.|||Ratio||Standard Deviation|Mean
2527635|NCT03557476|Primary|Total Cholesterol|Plasma total cholesterol levels|6 days||||mg/dL||Standard Deviation|Mean
2525538|NCT03816696|Secondary|Period 1: Absolute Values for Urinalysis Parameter: Specific Gravity|Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine.|Day 9|Safety Population.|||Ratio||Standard Deviation|Mean
2525539|NCT03816696|Secondary|Period 3: Absolute Values for Chemistry Parameters: Amylase, Lipase|Blood samples were collected to analyze the chemistry parameters: amylase and lipase.|Days 4, 7 and 10|Safety Population.|||Units per liter||Standard Deviation|Mean
2525540|NCT03816696|Secondary|Period 2: Absolute Values for Chemistry Parameters: Amylase, Lipase|Blood samples were collected to analyze the chemistry parameters: amylase and lipase.|Day 7|Safety Population.|||Units per liter||Standard Deviation|Mean
2525541|NCT03816696|Secondary|Period 1: Absolute Values for Chemistry Parameters: Amylase, Lipase|Blood samples were collected to analyze the chemistry parameters: amylase and lipase.|Day 9|Safety Population.|||Units per liter||Standard Deviation|Mean
2525542|NCT03816696|Secondary|Period 3: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein|Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.|Days 4, 7 and 10|Safety Population.|||Grams per liter||Standard Deviation|Mean
2525543|NCT03816696|Secondary|Period 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein|Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.|Day 7|Safety Population.|||Grams per liter||Standard Deviation|Mean
2525544|NCT03816696|Secondary|Period 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, Protein|Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein.|Day 9|Safety Population.|||Grams per liter||Standard Deviation|Mean
2525545|NCT03816696|Secondary|Period 3: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin|Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.|Days 4, 7 and 10|Safety Population.|||Micromoles per liter||Standard Deviation|Mean
2525546|NCT03816696|Secondary|Period 2: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin|Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.|Day 7|Safety Population.|||Micromoles per liter||Standard Deviation|Mean
2525547|NCT03816696|Secondary|Period 1: Absolute Values for Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin|Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin.|Day 9|Safety Population.|||Micromoles per liter||Standard Deviation|Mean
2525548|NCT03816696|Secondary|Period 3: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase|Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.|Days 4, 7 and 10|Safety Population.|||International units per liter||Standard Deviation|Mean
2525549|NCT03816696|Secondary|Period 2: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase|Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.|Day 7|Safety Population.|||International units per liter||Standard Deviation|Mean
2525550|NCT03816696|Secondary|Period 1: Absolute Values for Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase|Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase.|Day 9|Safety Population.|||International units per liter||Standard Deviation|Mean
2525551|NCT03816696|Secondary|Period 3: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen|Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.|Days 4, 7 and 10|Safety Population.|||Millimoles per liter||Standard Deviation|Mean
2525552|NCT03816696|Secondary|Period 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen|Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.|Day 7|Safety Population.|||Millimoles per liter||Standard Deviation|Mean
2525553|NCT03816696|Secondary|Period 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen|Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen.|Day 9|Safety Population.|||Millimoles per liter||Standard Deviation|Mean
2525554|NCT03816696|Secondary|Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin|Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.|Days 4, 7 and 10|Safety Population.|||Picograms||Standard Deviation|Mean
2525555|NCT03816696|Secondary|Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin|Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.|Day 7|Safety Population.|||Picograms||Standard Deviation|Mean
2525556|NCT03816696|Secondary|Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin|Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin.|Day 9|Safety Population.|||Picograms||Standard Deviation|Mean
2525557|NCT03816696|Secondary|Period 3: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume|Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.|Days 4, 7 and 10|Safety Population.|||Femtoliter||Standard Deviation|Mean
2525558|NCT03816696|Secondary|Period 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume|Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.|Day 7|Safety Population.|||Femtoliter||Standard Deviation|Mean
2527636|NCT03557476|Primary|Triglycerides|Plasma triglyceride levels|6 days||||mg/dL||Standard Deviation|Mean
2525559|NCT03816696|Secondary|Period 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume|Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume.|Day 9|Safety Population.|||Femtoliter||Standard Deviation|Mean
2525560|NCT03816696|Secondary|Period 3: Absolute Values for Hematology Parameter: Erythrocytes|Blood samples were collected to analyze the hematology parameter: erythrocytes.|Days 4, 7 and 10|Safety Population.|||Trillion cells per liter||Standard Deviation|Mean
2525561|NCT03816696|Secondary|Period 2: Absolute Values for Hematology Parameter: Erythrocytes|Blood samples were collected to analyze the hematology parameter: erythrocytes.|Day 7|Safety Population.|||Trillion cells per liter||Standard Deviation|Mean
2525562|NCT03816696|Secondary|Period 1: Absolute Values for Hematology Parameter: Erythrocytes|Blood samples were collected to analyze the hematology parameter: erythrocytes.|Day 9|Safety Population.|||Trillion cells per liter||Standard Deviation|Mean
2525563|NCT03816696|Secondary|Period 3: Absolute Values for Hematology Parameter: Hematocrit|Blood samples were collected to analyze the hematology parameter: hematocrit.|Days 4, 7 and 10|Safety Population.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2525564|NCT03816696|Secondary|Period 2: Absolute Values for Hematology Parameter: Hematocrit|Blood samples were collected to analyze the hematology parameter: hematocrit.|Day 7|Safety Population.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2525565|NCT03816696|Secondary|Period 1: Absolute Values for Hematology Parameter: Hematocrit|Blood samples were collected to analyze the hematology parameter: hematocrit.|Day 9|Safety Population.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2525566|NCT03816696|Secondary|Period 3: Absolute Values for Hematology Parameter: Hemoglobin|Blood samples were collected to analyze the hematology parameter: hemoglobin.|Days 4, 7 and 10|Safety Population.|||Grams per liter||Standard Deviation|Mean
2525567|NCT03816696|Secondary|Period 2: Absolute Values for Hematology Parameter: Hemoglobin|Blood samples were collected to analyze the hematology parameter: hemoglobin.|Day 7|Safety Population.|||Grams per liter||Standard Deviation|Mean
2525568|NCT03816696|Secondary|Period 1: Absolute Values for Hematology Parameter: Hemoglobin|Blood samples were collected to analyze the hematology parameter: hemoglobin.|Day 9|Safety Population.|||Grams per liter||Standard Deviation|Mean
2525569|NCT03816696|Secondary|Period 3: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count|Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.|Days 4, 7 and 10|Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||10^9 cells per liter||Standard Deviation|Mean
2525570|NCT03816696|Secondary|Period 2: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count|Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.|Day 7|Safety Population.|||10^9 cells per liter||Standard Deviation|Mean
2525571|NCT03816696|Secondary|Period 1: Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count|Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count.|Day 9|Safety Population.|||10^9 cells per liter||Standard Deviation|Mean
2525572|NCT03816696|Secondary|Period 3: Change From Baseline in Body Temperature|Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11|Safety Population.|||Degrees Celsius||Standard Deviation|Mean
2525573|NCT03816696|Secondary|Period 2: Change From Baseline in Body Temperature|Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7|Safety Population.|||Degrees Celsius||Standard Deviation|Mean
2525574|NCT03816696|Secondary|Period 1: Change From Baseline in Body Temperature|Body temperature was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5|Safety Population.|||Degrees Celsius||Standard Deviation|Mean
2525575|NCT03816696|Secondary|Period 3: Change From Baseline in Respiratory Rate|Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11|Safety Population.|||Breaths per minute||Standard Deviation|Mean
2525576|NCT03816696|Secondary|Period 2: Change From Baseline in Respiratory Rate|Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7|Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||Breaths per minute||Standard Deviation|Mean
2525636|NCT03816696|Primary|Period 2: Cmax of GSK3640254 for GSK3640254 Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525577|NCT03816696|Secondary|Period 1: Change From Baseline in Respiratory Rate|Respiratory rate was measured in the semi-recumbent position after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5|Safety Population.|||Breaths per minute||Standard Deviation|Mean
2525578|NCT03816696|Secondary|Period 3: Change From Baseline in Pulse Rate|Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11|Safety Population.|||Beats per minute||Standard Deviation|Mean
2525579|NCT03816696|Secondary|Period 2: Change From Baseline in Pulse Rate|Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7|Safety Population.|||Beats per minute||Standard Deviation|Mean
2525580|NCT03816696|Secondary|Period 1: Change From Baseline in Pulse Rate|Pulse rate was measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5|Safety Population.|||Beats per minute||Standard Deviation|Mean
2525581|NCT03816696|Secondary|Period 3: Change From Baseline in SBP and DBP|SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11|Safety Population.|||Millimeters of mercury||Standard Deviation|Mean
2525582|NCT03816696|Secondary|Period 2: Change From Baseline in SBP and DBP|SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day 1, Pre-dose), Days 2, 3, 4, 5, 6 and 7|Safety Population.|||Millimeters of mercury||Standard Deviation|Mean
2525583|NCT03816696|Secondary|Period 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured in the semi-recumbent position with a completely automated device. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day 1, Pre-dose), Days 2, 3, 4 and 5|Safety Population.|||Millimeters of mercury||Standard Deviation|Mean
2525584|NCT03816696|Secondary|Period 3: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB|Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline; Day 1: 2 hours, 4 hours; Days 4, 5 and 7: Pre-dose, 2 hours and 4 hours; Day 10|Safety Population.|||Milliseconds||Standard Deviation|Mean
2525585|NCT03816696|Secondary|Period 2: Change From Baseline in PR Interval, QRS Duration, QT Interval, QTcF, QTcB|Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline; Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours|Safety Population.|||Milliseconds||Standard Deviation|Mean
2525586|NCT03816696|Secondary|Period 1: Change From Baseline in PR Interval, QRS Duration, QT Interval, Fridericia QT Correction Formula (QTcF), Bazett's QT Correction Formula (QTcB)|Twelve-lead electrocardiograms (ECG) were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline, Day 1: 2 hours, 4 hours; Day 5: Pre-dose, 2 hours and 4 hours|Safety Population.|||Milliseconds||Standard Deviation|Mean
2525587|NCT03816696|Secondary|Period 3: Number of Participants With Urinalysis Dipstick Results|Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present), and 2+ (moderate concentrations present)indicating proportional concentrations in the urine sample.|Days 4, 7 and 10|Safety Population.|||Participants|||Count of Participants
2525588|NCT03816696|Secondary|Period 2: Number of Participants With Urinalysis Dipstick Results|Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present), and 2+ (moderate concentrations present) indicating proportional concentrations in the urine sample.|Day 7|Safety Population.|||Participants|||Count of Participants
2525665|NCT03807089|Primary|Percentage of Patients With At Least One Adenoma|Compare adenoma detection rate between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.|1 hour||||Participants|||Count of Participants
2547891|NCT02896595|Secondary|Intraoperative Hemodynamics|mean arterial pressure|Up to 270 minutes|Data was not collected||||||
2525589|NCT03816696|Secondary|Period 1: Number of Participants With Urinalysis Dipstick Results|Urine samples were collected at indicated time points to analyze parameters including glucose, protein, occult blood, ketones, nitrite, bilirubin and leukocyte esterase levels by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace, 1+ (low concentrations present) and 2+ (moderate concentrations present) indicating proportional concentrations in the urine sample.|Day 9|Safety Population.|||Participants|||Count of Participants
2525590|NCT03816696|Secondary|Period 3: Change From Baseline in Urinalysis Parameter: pH|Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 2 Day 7) and at Days 4, 7 and 10|Safety Population.|||pH||Standard Deviation|Mean
2525591|NCT03816696|Secondary|Period 2: Change From Baseline in Urinalysis Parameter: pH|Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 1 Day 9) and at Day 7|Safety Population.|||pH||Standard Deviation|Mean
2525592|NCT03816696|Secondary|Period 1: Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH)|Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day -1) and at Day 9|Safety Population.|||pH||Standard Deviation|Mean
2525593|NCT03816696|Secondary|Period 3: Change From Baseline in Urinalysis Parameter: Urobilinogen|Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 2 Day 7) and at Days 4, 7 and 10|Safety Population.|||Micromoles per liter||Standard Deviation|Mean
2525594|NCT03816696|Secondary|Period 2: Change From Baseline in Urinalysis Parameter: Urobilinogen|Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 1 Day 9) and at Day 7|Safety Population.|||Micromoles per liter||Standard Deviation|Mean
2525595|NCT03816696|Secondary|Period 1: Change From Baseline in Urinalysis Parameter: Urobilinogen|Urine samples were collected to analyze the urinalysis parameter: urobilinogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day -1) and at Day 9|Safety Population.|||Micromoles per liter||Standard Deviation|Mean
2525596|NCT03816696|Secondary|Period 3: Change From Baseline in Urinalysis Parameter: Specific Gravity|Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 2 Day 7) and at Days 4, 7 and 10|Safety Population.|||Ratio||Standard Deviation|Mean
2525597|NCT03816696|Secondary|Period 2: Change From Baseline in Urinalysis Parameter: Specific Gravity|Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 1 Day 9) and at Day 7|Safety Population.|||Ratio||Standard Deviation|Mean
2525598|NCT03816696|Secondary|Period 1: Change From Baseline in Urinalysis Parameter: Specific Gravity|Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day -1) and at Day 9|Safety Population.|||Ratio||Standard Deviation|Mean
2525599|NCT03816696|Secondary|Period 3: Change From Baseline in Chemistry Parameters: Amylase, Lipase|Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 2 Day 7) and at Days 4, 7 and 10|Safety Population.|||Units per liter||Standard Deviation|Mean
2525678|NCT03805672|Primary|Deep Vein Thrombosis Resolution|Evaluation of DVT resolution|6 weeks||||Participants|||Count of Participants
2538716|NCT03094806|Primary|Length of Stay|Time of admission to time of discharge from hospital|Up to 2 weeks||||days||95% Confidence Interval|Median
2525600|NCT03816696|Secondary|Period 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase|Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 1 Day 9) and at Day 7|Safety Population.|||Units per liter||Standard Deviation|Mean
2525601|NCT03816696|Secondary|Period 1: Change From Baseline in Chemistry Parameters: Amylase, Lipase|Blood samples were collected to analyze the chemistry parameters: amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day -1) and at Day 9|Safety Population.|||Units per liter||Standard Deviation|Mean
2525602|NCT03816696|Secondary|Period 3: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein|Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 2 Day 7) and at Days 4, 7 and 10|Safety Population.|||Grams per liter||Standard Deviation|Mean
2525603|NCT03816696|Secondary|Period 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein|Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 1 Day 9) and at Day 7|Safety Population.|||Grams per liter||Standard Deviation|Mean
2525604|NCT03816696|Secondary|Period 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Protein|Blood samples were collected to analyze the chemistry parameters: albumin, globulin and protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day -1) and at Day 9|Safety Population.|||Grams per liter||Standard Deviation|Mean
2525605|NCT03816696|Secondary|Period 3: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin|Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 2 Day 7) and at Days 4, 7 and 10|Safety Population.|||Micromoles per liter||Standard Deviation|Mean
2525606|NCT03816696|Secondary|Period 2: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin|Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 1 Day 9) and at Day 7|Safety Population.|||Micromoles per liter||Standard Deviation|Mean
2525607|NCT03816696|Secondary|Period 1: Change From Baseline in Chemistry Parameters: Urate, Creatinine, Bilirubin, Direct Bilirubin|Blood samples were collected to analyze the chemistry parameters: urate, creatinine, bilirubin and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day -1) and at Day 9|Safety Population.|||Micromoles per liter||Standard Deviation|Mean
2525608|NCT03816696|Secondary|Period 3: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase|Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 2 Day 7) and at Days 4, 7 and 10|Safety Population.|||International units per liter||Standard Deviation|Mean
2525609|NCT03816696|Secondary|Period 2: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, ALT, ALP, AST, Gamma-glutamyl Transferase|Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 1 Day 9) and at Day 7|Safety Population.|||International units per liter||Standard Deviation|Mean
2525610|NCT03816696|Secondary|Period 1: Change From Baseline in Chemistry Parameters: Creatine Kinase, Lactate Dehydrogenase, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase|Blood samples were collected to analyze the chemistry parameters: creatine kinase, lactate dehydrogenase, ALT, ALP, AST and gamma-glutamyl transferase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day -1) and at Day 9|Safety Population.|||International units per liter||Standard Deviation|Mean
2525611|NCT03816696|Secondary|Period 3: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen|Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 2 Day 7) and at Days 4, 7 and 10|Safety Population.|||Millimoles per liter||Standard Deviation|Mean
2525612|NCT03816696|Secondary|Period 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen|Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 1 Day 9) and at Day 7|Safety Population.|||Millimoles per liter||Standard Deviation|Mean
2525613|NCT03816696|Secondary|Period 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen|Blood samples were collected to analyze the chemistry parameters: glucose, cholesterol, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day -1) and at Day 9|Safety Population.|||Millimoles per liter||Standard Deviation|Mean
2525614|NCT03816696|Secondary|Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin|Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 2 Day 7) and at Days 4, 7 and 10|Safety Population.|||Picograms||Standard Deviation|Mean
2525615|NCT03816696|Secondary|Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin|Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 1 Day 9) and at Day 7|Safety Population.|||Picograms||Standard Deviation|Mean
2525616|NCT03816696|Secondary|Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin|Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day -1) and at Day 9|Safety Population.|||Picograms||Standard Deviation|Mean
2525617|NCT03816696|Secondary|Period 3: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume|Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 2 Day 7) and at Days 4, 7 and 10|Safety Population.|||Femtoliter||Standard Deviation|Mean
2525618|NCT03816696|Secondary|Period 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume|Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 1 Day 9) and at Day 7|Safety Population.|||Femtoliter||Standard Deviation|Mean
2525619|NCT03816696|Secondary|Period 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume|Blood samples were collected to analyze the hematology parameter: erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day -1) and at Day 9|Safety Population.|||Femtoliter||Standard Deviation|Mean
2525620|NCT03816696|Secondary|Period 3: Change From Baseline in Hematology Parameter: Erythrocytes|Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 2 Day 7) and at Days 4, 7 and 10|Safety Population.|||Trillion cells per liter||Standard Deviation|Mean
2525621|NCT03816696|Secondary|Period 2: Change From Baseline in Hematology Parameter: Erythrocytes|Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 1 Day 9) and at Day 7|Safety Population.|||Trillion cells per liter||Standard Deviation|Mean
2525622|NCT03816696|Secondary|Period 1: Change From Baseline in Hematology Parameter: Erythrocytes|Blood samples were collected to analyze the hematology parameter: erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day -1) and at Day 9|Safety Population.|||Trillion cells per liter||Standard Deviation|Mean
2525623|NCT03816696|Secondary|Period 3: Change From Baseline in Hematology Parameter: Hematocrit|Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 2 Day 7) and at Days 4, 7 and 10|Safety Population.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2525893|NCT03752567|Secondary|Levels of LDL-cholesterol|variation of LDL-cholesterol (mg/dl) when the patient is followed by the community pharmacist as a case manager, as a result of greater adherence to therapy|12 months||||percentage of variation||Standard Deviation|Mean
2525624|NCT03816696|Secondary|Period 2: Change From Baseline in Hematology Parameter: Hematocrit|Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 1 Day 9) and at Day 7|Safety Population.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2525625|NCT03816696|Secondary|Period 1: Change From Baseline in Hematology Parameter: Hematocrit|Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day -1) and at Day 9|Safety Population.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2525626|NCT03816696|Secondary|Period 3: Change From Baseline in Hematology Parameter: Hemoglobin|Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 2 Day 7) and at Days 4, 7 and 10|Safety Population.|||Grams per liter||Standard Deviation|Mean
2525627|NCT03816696|Secondary|Period 2: Change From Baseline in Hematology Parameter: Hemoglobin|Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 1 Day 9) and at Day 7|Safety Population.|||Grams per liter||Standard Deviation|Mean
2525628|NCT03816696|Secondary|Period 1: Change From Baseline in Hematology Parameter: Hemoglobin|Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day -1) and at Day 9|Safety Population.|||Grams per liter||Standard Deviation|Mean
2525629|NCT03816696|Secondary|Period 3: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count|Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 3. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 2 Day 7) and at Days 4, 7 and 10|Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||10^9 cells per liter||Standard Deviation|Mean
2525630|NCT03816696|Secondary|Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count|Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Period 1 Day 9) and at Day 7|Safety Population.|||10^9 cells per liter||Standard Deviation|Mean
2525631|NCT03816696|Secondary|Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count|Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits, before the first treatment in Period 1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day -1) and at Day 9|Safety Population.|||10^9 cells per liter||Standard Deviation|Mean
2525632|NCT03816696|Secondary|Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; and other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least 1 dose of study medication.|Up to Day 27|Safety Population.|||Participants|||Count of Participants
2525633|NCT03816696|Primary|Period 3: Ctau of GSK3640254 for Dolutegravir + GSK3640254 Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525634|NCT03816696|Primary|Period 2: Ctau of GSK3640254 for GSK3640254 Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525635|NCT03816696|Primary|Period 3: Cmax of GSK3640254 for Dolutegravir + GSK3640254 Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525694|NCT03801044|Secondary|Association Between Number of Kerley B Lines by Ultrasound Left Ventricle End Diastolic Diameter (mm) Obtained by the Cardiologist With Echocardiography|Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle end diastolic diameter (mm) obtained by the cardiologist with echocardiography|4 months|PD patients (n=21)|||cm||Inter-Quartile Range|Median
2525637|NCT03816696|Primary|Period 3: AUC(0 to Tau) of GSK3640254 for Dolutegravir + GSK3640254 Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Hours* microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525638|NCT03816696|Primary|Period 2: AUC(0 to Tau) of GSK3640254 for GSK3640254 Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK3640254. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Day 7: Pre-dose, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Hours* microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525639|NCT03816696|Primary|Period 3: Ctau of Dolutegravir for Dolutegravir + GSK3640254 Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525640|NCT03816696|Primary|Period 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of Dolutegravir for Dolutegravir Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525641|NCT03816696|Primary|Period 3: Cmax of Dolutegravir for Dolutegravir + GSK3640254 Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525642|NCT03816696|Primary|Period 1: Maximum Observed Concentration (Cmax) of Dolutegravir for Dolutegravir Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525643|NCT03816696|Primary|Period 3: AUC(0 to Tau) of Dolutegravir for Dolutegravir + GSK3640254 Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Day 7: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Hours* nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525644|NCT03816696|Primary|Period 1: Area Under the Plasma Concentration-time Curve From Time 0 to the End of the Dosing (AUC[0 to Tau]) of Dolutegravir for Dolutegravir Arm|Blood samples were collected at the indicated time points for pharmacokinetic analysis of dolutegravir. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic Parameter Population consisted of all participants who underwent plasma pharmacokinetic sampling and had evaluable pharmacokinetic parameters estimated.|Day 5: Pre-dose, 1, 1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours post-dose|Pharmacokinetic Parameter Population.|||Hours* nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2525645|NCT03811093|Primary|Change in Weight of Body Fat|The percentage of body fat for each participant was measured using Bioelectrical Impedance Analysis (BIA). That percentage is then multiplied by the total body weight of the participant in order to calculate the weight in pounds of the participants body fat.|In order to determine change over time, each participants body fat weight will be calculated before any treatment at the first therapy session and calculated again to determine if there exists any change at the end of three weeks therapy.|"Number of Care as Usual Group participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured.~Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy."|||Pounds||Standard Deviation|Mean
2525646|NCT03811093|Primary|Change in Body Circumference Measurements|The prescribed body circumference measurements of the chest, right arm, upper-waist, mid-waist, hips, and right thigh are summed for each participant and recorded.|In order to determine change over time, the prescribed body measurements will be summed for each participant and recorded before any treatment at first therapy session and recorded again for comparison at the end of three weeks therapy.|Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy.|||Inches||95% Confidence Interval|Mean
2525647|NCT03811093|Primary|Change in Body Fat Percentage|Measured change in body fat as a percentage of total weight.|In order to determine change over time, body fat as a percentage of body weight will be measured before any treatment at first therapy session and measured again for comparison at the end of three weeks therapy.|"Number of Care as Usual Group participants measured was reduced by two morbidly obese participants whose body fat percentage could not be accurately measured.~Number of Sham Group was reduced by a drop out of 4 participants due to schedule conflicts and lack of efficacy."|||Percentage of Body Fat||95% Confidence Interval|Mean
2525648|NCT03809104|Secondary|Box and Block Test|The Box and Block Test (BBT) can measure the unilateral gross manual dexterity. The set up of the BBT test includes a wooden box with 150 wooden blocks inside. The wooden box is divided into two compartments. One filled with blocks, and the other is empty.During this test, the patient is seated upright in a chair and needs to transfer the wooden blocks, one by one, from one compartment to the other. The patient is scored based on the number of blocks he or she can transferred from one compartment to the other in 60 seconds.|baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs||||boxes||Standard Deviation|Mean
2525695|NCT03801044|Secondary|Association Between Number of Kerley B Lines by Ultrasound and Presence of Third Sound/Pretibial Edema by Auscultation/Edema by Physical Examination|Assessing the relationship between number of Kerley B lines by ultrasound and presence of third sound (S3) by auscultation/edema by physical examination|4 months|PD patients (n=21)|||Participants|||Count of Participants
2553717|NCT02770625|Secondary|Acid Phosphatase (ACP) Level (U/L)||from baseline to Week 24||||U/L||Standard Deviation|Mean
2525649|NCT03809104|Secondary|Strength of Biceps Brachii and Triceps Brachii of the Dominant Upper Extremity|"This research uses MicroFET3 to measure the the maximal voluntary isometric contraction of the biceps and triceps. Measurements are taken 2 times and the results are averaged. MicroFET3 is a electronic hand-held dynamometer that can measure muscle strength. The range of muscle testing of the device ranges from 0-150 lbs force.(Digital Dynamometer and Inclinometer | MicroFET®3) ."|baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs||||kg||Standard Deviation|Mean
2525650|NCT03809104|Secondary|Range of Motions in Dominant Upper Extremity|Use goniometry for range of motion measurement. The joints measured include shoulder, elbow, and wrist of the dominant side.|baseline;1, 2, and 3 months after the intervention of the virtual reality-based rehabilitation programs||||degree||Standard Deviation|Mean
2525651|NCT03809104|Primary|Change of Appendicular Skeletal Muscle Mass Between the Third Month and the Baseline|"Appendicular skeletal muscle mass (ASM) is deﬁned by the sum of the lean soft tissue mass of four limbs. Appendicular skeletal muscle mass index (ASMI) is defined as ASM (kg) divided by squared height (m).The body composition was measured via bio-electrical impedance analysis by Omron KARADA Scan Body Composition & Scale (HBF-701). A participant was considered to have low muscle mass if his or her ASMI was below −2 standard deviations of the reference defined in previous studies from Taiwan (6.76 kg/m2 for men and 5.28 kg/m2 for women). Participants with ASMI in the lowest 20% of the sex‐specific distribution were considered to have low muscle mass, too. Increased of ASMI after virtual reality-based rehabilitation programs is considered to be better.~The change was calculated by the data of the third month minus the baseline data."|3 months after the intervention of the virtual reality-based rehabilitation programs||||kg/meter square||Standard Deviation|Mean
2525652|NCT03809104|Primary|Change of Walking Speed Between the Third Month and the Baseline|"Timing starts after the patient starts walking and stops at the point when a patient reaches a distance of 6 meters. The gait speed in measured twice and the final measurement is the average of the two scores. The patient is allowed to rest for 10 minutes in between measurement.~The change was calculated by the data of the third month minus the baseline data."|3 months after the intervention of the virtual reality-based rehabilitation programs||||meter/second||Standard Deviation|Mean
2525653|NCT03809104|Primary|Change of Hand-grip Strength of the Dominant Hand Between the Third Month and the Baseline|"The measurements of the HGS were determined by means of the JAMAR-Dynamometer. The forearm was held in neutral position and the wrist at a 0 to 30° extension. The instrument was held freely: neither the hand nor the forearm was allowed to rest on a surface. Three measurements were done and recorded as the average of the three measurements and the participants rested for 1 minute in between measurements.~The change was calculated by the data of the third month minus the baseline data."|3 months after the intervention of the virtual reality-based rehabilitation programs||||kg||Standard Deviation|Median
2525654|NCT03808493|Secondary|λz: Terminal Disposition Phase Rate Constant for TAK-438F||Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, and whose PK data were evaluable.|||per hour (1/hour)||Standard Deviation|Mean
2525655|NCT03808493|Secondary|MRT∞,ev: Mean Residence Time After Extravascular Administration From Time 0 to Infinity for TAK-438F||Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, and whose PK data were evaluable.|||hour||Standard Deviation|Mean
2525656|NCT03808493|Secondary|Tmax: Time of First Occurrence of Maximum Plasma Concentration (Cmax) for TAK-438F||Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, and whose PK data were evaluable.|||hour||Full Range|Median
2525657|NCT03808493|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F||Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, and whose PK data were evaluable.|||h*ng/mL||Standard Deviation|Geometric Mean
2525658|NCT03808493|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-438F||Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, and whose PK data were evaluable.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2525659|NCT03808493|Primary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Plasma Concentration for TAK-438 Free Base (TAK-438F)||Day 1 pre-dose and at multiple time points (up to 48 hours; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours) post-dose|The pharmacokinetic (PK) analysis set was defined as all participants who received at least one dose of study drug, and whose PK data were evaluable.|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Geometric Mean
2525660|NCT03807544|Primary|Number of Participants Who Experienced Effective Electrode Placement|Compare two active treatment electrode locations to evaluate the effect of electrode placement on the appearance of sensory nerve action potentials, including tingling sensation, along the stimulated nerve using electromyography (EMG).|2 hours, length of study visit||||Participants|||Count of Participants
2525661|NCT03807089|Other Pre-specified|Size of Adenomas Detected||1 hour||||mm||Standard Deviation|Mean
2525662|NCT03807089|Other Pre-specified|Size of Polyps Detected|Polyp size was estimated prior to polypectomy by comparing the polyp with objects of known dimension (biopsy forceps, polypectomy snares).|1 hour||||mm||Standard Deviation|Mean
2525663|NCT03807089|Secondary|Mean Number of Adenomas Identified Per Patient With Polyps|Compare average number of adenomas found per patient with polyps between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.|1 hour||||Number of Adenomas Per Patient||Standard Deviation|Mean
2525664|NCT03807089|Secondary|Overall Polyp Detection Rate|Compare polyp detection rate (percent of patients with at least one polyp detected) between patients undergoing a colonoscopy with Pentax Retroview colonoscope and pediatric colonoscope.|1 hour||||Participants|||Count of Participants
2553718|NCT02770625|Secondary|Chemokine Ligand (CCL-18) Level [ng/mL]||from baseline to Week 24||||ng/mL||Standard Deviation|Mean
2525666|NCT03806270|Other Pre-specified|The Orbital Muscle Name Which OCR Occurred During it's Traction|The investigator records the orbital muscle name which OCR occurred during its traction; like Right eye medial rectus muscle, Right eye inferior oblique muscle, Right eye lateral rectus muscle, Left eye medial rectus muscle, Left eye inferior oblique muscle, Left eye lateral rectus muscle.|within 5 minutes after defining the OCR occurrence, at the strabismus surgery operation, through study completion an average of 6 months|The names of the orbital muscles which OCR occurred after traction was performed|||Orbital muscles which OCR occurred|Orbital muscles which OCR occurred||Count of Units
2525667|NCT03806270|Other Pre-specified|Number of Orbital Muscles of the Participants With Different Considerations Taken With Respect to the Treatment of OCR|The investigator records every OCR treatment like; pausing surgery, atropin 20mcg/kg intravenous treatment or cardiac resuscitation.|within 5 minutes after defining the OCR occurrence, at the strabismus surgery operation, through study completion an average of 6 months|"midazolam group includes 15 participants; total 29 orbital muscles operated, in 15 of them OCR occurred.~Midazolam&Hydroxyzine1/2 group includes 15 participants; total 28 orbital muscles operated, in 6 of them OCR occurred.~Midazolam&Hydroxyzine group includes 15 participants; total 30 orbital muscles operated, in 1 of them OCR occurred."|||number of orbital muscle/s, OCR occured|number of orbital muscle/s, OCR occured||Number
2525668|NCT03806270|Secondary|Ramsay Sedation Score|"If Awake; Ramsay 1: Anxious, agitated, restless; Ramsay 2: Cooperative, oriented, tranquil; Ramsay 3: Responsive to commands only If Asleep; Ramsay 4: Brisk response to a light glabellar tap or loud auditory stimulus;~Ramsay 5: Sluggish response to a light glabellar tap or loud auditory stimulus; Ramsay 6:~No response to a light glabellar tap or loud auditory stimulus"|After patient transferred into the operation theatre and before anesthesia induction, through study completion an average of 6 months|every participant that had only midazolam or one of the midazolam and hydroxizine premedications before surgery. Ramsay sedation score is evaluated by the investigator before surgery, in the operating theatre without knowing which premedication was utilized to the participant.|||Participants|||Count of Participants
2525669|NCT03806270|Primary|Number of Observed Oculocardiac Reflex(OCR)|The OCR is a heartbeat anomaly(bradycardia, any arrhythmia, or cardiac arrest) associated with traction applied to the extraocular muscles during strabismus surgery. The specific criteria were as follows: the lowest heart rate observed within 120 seconds from EKG monitorization, after every orbital muscle traction, was less than 20% of the heart rate observed directly preceding traction of the orbital muscle. Additionally, any kind of arrhythmia or cardiac arrest occurrence within 120 seconds after orbital muscle traction was also defined as an OCR.|2 minutes, at the strabismus surgery operation after recording Heart Rate-3, through study completion an average of 6 months|OCR occurrence (0: no and 1: yes) was recorded for every orbital muscle. So it is not equal to the participant number.|||orbital muscles|orbital muscles||Count of Units
2525670|NCT03806270|Primary|Heart Rate-3|The lowest heart rate observed from EKG monitorization, after every orbital muscle traction within 120 seconds. Heart rate-3 is a data, not an assessing change, which is recorded within 120 seconds after traction applied.|within 120 seconds after the orbital muscle traction, at the strabismus surgery operation, through study completion an average of 6 months|"Orbital muscles which surgery performed. It is not equal to the participant number. Related to strabismus surgery, the number of muscles surgery performed on a participant might change; like as one eye 2 muscles, two eyes but 1 muscle for each eye or two eyes 2 muscle for each."|||beats per minute|Orbital Muscles|Standard Deviation|Mean
2525671|NCT03806270|Primary|Heart Rate-2|The heart rate observed from EKG monitorization at the time operator warns the investigator just before the traction of the orbital muscle. Heart rate-2 is a data, not an assessing change, which is recorded during the operation at the time operator warns. The heart rate observed from EKG monitorization, before every orbital muscle traction at the time the operator's warning before traction.|1 minute, at the strabismus surgery operation, through study completion an average of 6 months|"Orbital muscles which surgery performed. It is not equal to the participant number. Related to strabismus surgery, the number of muscles surgery performed on a participant might change; like as one eye 2 muscles, two eyes but 1 muscle for each eye or two eyes 2 muscle for each."|||beats per minute|Orbital Muscles|Standard Deviation|Mean
2525672|NCT03806270|Primary|Heart Rate-1|"The lowest heart rate observed from EKG monitorization at the time-out after the anesthesia induction, and just before the surgery starts. Heart rate-1 is a data, not an assessing change, which is recoded during the time-out. The time-out is when the patient's name, the procedure, the surgent name is repeated before the operation starts."|"1 minute, at the time out, through study completion an average of 6 months"|"Heart Rate1 was measured from each of the 45 participants, during time-out right after anesthesia induction and before surgery begins. This measurement is not related to orbital muscle traction."|||beats per minute||Standard Deviation|Mean
2525673|NCT03805971|Primary|Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.|"Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.~Quantitative criteria are presented in this table. Here is presented the vascular density."|One day|Some criteria were not assessable for some patients.|||Vessels/1.13 mm^2 (full optic area)||Standard Deviation|Mean
2525674|NCT03805971|Primary|Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.|"Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.~Quantitative criteria are presented in this table. Here is presented the mean cellular density"|One day|Some criteria were not assessable for some patients.|||number of cells/10^4µm^2||Standard Deviation|Mean
2525675|NCT03805971|Secondary|Quality of the pCLE Acquisition|The investigators performing the thoracoscopy had to score the pCLE acquisition. Three level of quality were used: Good, Acceptable, Low.|One day||||Participants|||Count of Participants
2525676|NCT03805971|Primary|Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.|"Eleven preselected pCLE criteria were assessed in their ability to distinguish benign from malignant pleura.~Here are presented Mean cell size and maximum vascular diameter"|One day|Some criteria were not assessable for some patients.|||µm||Standard Deviation|Mean
2525677|NCT03805971|Primary|Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.|Eleven preselected criteria were assessed in their ability to distinguish benign from malignant pleura Qualitative variables are presented in this table|One day.||||Participants|||Count of Participants
2525679|NCT03801148|Primary|AUC0_infpred: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Predicted Value of the Last Quantifiable Concentration for Dexlansoprazole||Day 1 pre-dose and at multiple time points (up to 24 hours) post dose|PK evaluable set: participants enrolled into study, received at least one dose of study drug, were not discontinued from study and replaced with other participants, completed PK sampling in both periods, complied sufficiently with protocol, displayed evaluable PK profiles. PK analysis population where data at specified time points was available.|||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2525680|NCT03801148|Primary|AUC0_infobs: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value of the Last Quantifiable Concentration for Dexlansoprazole||Day 1 pre-dose and at multiple time points (up to 24 hours) post dose|PK evaluable set: participants enrolled into study, received at least one dose of study drug, were not discontinued from study and replaced with other participants, completed PK sampling in both periods, complied sufficiently with protocol, displayed evaluable PK profiles. PK analysis population where data at specified time points was available.|||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2525681|NCT03801148|Primary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole||Day 1 pre-dose and at multiple time points (up to 24 hours) post dose|The PK evaluable set included all participants who enrolled into study and received at least one dose of study drug, were not discontinued from study and replaced with other participants, who completed PK sampling in both periods, complied sufficiently with protocol, and displayed evaluable PK profiles.|||nanogram*hour per milliliter(ng*hour/mL)||Geometric Coefficient of Variation|Geometric Mean
2525682|NCT03801148|Primary|Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole||Day 1 pre-dose and at multiple time points (up to 24 hours) post dose|The pharmacokinetic (PK) evaluable set included all participants who enrolled into study and received at least one dose of study drug, were not discontinued from study and replaced with other participants, who completed PK sampling in both periods, complied sufficiently with protocol, and displayed evaluable PK profiles.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2525683|NCT03801044|Secondary|Association Between Number of Kerley B Lines by Ultrasound and NT-proBNP Level (pg/ml) by Elecsys proBNP Immunoassay|Assessing the relationship between number of Kerley B lines by ultrasound and NT-proBNP level (pg/ml) by Elecsys proBNP Immunoassay|4 months|PD patients|||pg/ml||Inter-Quartile Range|Median
2525684|NCT03801044|Secondary|Association Between Number of Kerley B Lines by Ultrasound and Bioimpedance Analysis [Assessed With the Body Composition Monitor; Normovolemic if Their Result Between -1,1 lt and 1,1 lt)|Assessing the relationship between number of Kerley B lines by ultrasound and bioimpedance analysis [assessed with the body composition monitor; normovolemic if their result between -1,1 lt and 1,1 lt)|4 months|PD patients (n=21)|||liter||Inter-Quartile Range|Median
2525685|NCT03801044|Secondary|Association Between Number of Kerley B Lines by Ultrasound and Pulmonary Artery Systolic Pressure (mmHg) Obtained by the Cardiologist With Echocardiography|Assessing the relationship between number of Kerley B lines by ultrasound and pulmonary artery systolic pressure (mmHg) obtained by the cardiologist with echocardiography|4 months|PD patients (n=21)|||mmHg||Inter-Quartile Range|Median
2525686|NCT03801044|Secondary|Association Between Number of Kerley B Lines by Ultrasound and Early Mitral Inflow Velocity and Mitral Annular Early Diastolic Velocity (E/E') Obtained by the Cardiologist With Echocardiography|Assessing the relationship between number of Kerley B lines by ultrasound and early mitral inflow velocity and mitral annular early diastolic velocity (E/E') obtained by the cardiologist with echocardiography|4 months|PD patients (n=21)|||rate||Inter-Quartile Range|Median
2525687|NCT03801044|Secondary|Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Filling Velocity (cm/Sec) Obtained by the Cardiologist With Echocardiography|Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle filling velocity (cm/sec) obtained by the cardiologist with echocardiography|4 months|PD patients (n=21)|||cm/sec||Inter-Quartile Range|Median
2525688|NCT03801044|Secondary|Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle Mass Index (g/m2) Obtained by the Cardiologist With Echocardiography|Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle mass index (g/m2) obtained by the cardiologist with echocardiography|4 months|PD patients (n=21)|||g/m2||Inter-Quartile Range|Median
2525689|NCT03801044|Secondary|Association Between Number of Kerley B Lines by Ultrasound and Left Atrial Volume (ml) Obtained by the Cardiologist With Echocardiography|Assessing the relationship between number of Kerley B lines by ultrasound and left atrial volume (ml) obtained by the cardiologist with echocardiography|4 months|PD patients (n=21)|||ml||Inter-Quartile Range|Median
2525690|NCT03801044|Secondary|Association Between Number of Kerley B Lines by Ultrasound and Left Ventricle End Diastolic Volume (ml) Obtained by the Cardiologist With Echocardiography|Assessing the relationship between number of Kerley B lines by ultrasound and left ventricle end diastolic volume (ml) obtained by the cardiologist with echocardiography|4 months|PD patients (n=21)|||ml||Inter-Quartile Range|Median
2525691|NCT03801044|Secondary|Association Between Number of Kerley B Lines by Ultrasound and Ejection Fraction (%) Obtained by the Cardiologist With Echocardiography|Assessing the relationship between number of Kerley B lines by ultrasound and ejection fraction (%) obtained by the cardiologist with echocardiography|4 months|PD patients (n=21)|||percentage of ejection fraction||Inter-Quartile Range|Median
2525692|NCT03801044|Secondary|Association Between Number of Kerley B by Ultrasound and Posterior Wall Thickness (mm) Obtained by the Cardiologist With Echocardiography|Assessing the relationship between number of Kerley B by ultrasound and posterior wall thickness (mm) obtained by the cardiologist with echocardiography|4 months|PD patients (n=21)|||cm||Inter-Quartile Range|Median
2525693|NCT03801044|Secondary|Association Between Number of Kerley B Lines by Ultrasound Interventricular Septum Thickness (mm) Obtained by the Cardiologist With Echocardiography|Assessing the relationship between number of Kerley B by ultrasound and interventricular septum thickness (mm) (mm) obtained by the cardiologist with echocardiography|4 months|PD patients (n=21)|||cm||Inter-Quartile Range|Median
2525762|NCT03782181|Primary|Dynamometer|A back muscle dynamometer was used to measure isometric back muscle strength.|5 minutes|Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).|||Newtons.||Standard Deviation|Mean
2525696|NCT03801044|Secondary|Association Between Number of Kerley B Lines by Ultrasound and Class of New York Heart Association Classification|Assessing the relationship between number of Kerley B lines by ultrasound and class of New York Heart Association Classification|4 months|PD patients (n=21)|||percentage of NYHA Class 1|||Number
2525697|NCT03801044|Secondary|Association Between Number of Kerley B Lines by Ultrasound and Dyspnea by Questionnaire|Assessing the relationship between number of Kerley B lines by ultrasound and dyspnea by questionnaire|4 months|PD patients (n=21)|||percentage of participants|||Number
2525698|NCT03801044|Primary|Association Between Number of Kerley B Lines by Ultrasound and Serum VEGF-C Level (pg/ml) by Enzyme-linked Immunosorbent Assay|Assessing the relationship between number of Kerley B lines by ultrasound and serum VEGF-C level (pg/ml) by enzyme-linked immunosorbent assay|4 months|All peritoneal dialysis patients in the clinic invited to the study. Two patients were excluded because of immobility|||ng/ml||Inter-Quartile Range|Median
2525699|NCT03796260|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline through the end of study (up to clinical cut-off date 04 Feb 2019 [27 days])|The Safety Population included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||Percentage of Participants|||Number
2525700|NCT03796260|Primary|Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite|The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern.|At pre-defined intervals from study Day 1 through Day 5 of each Period (Periods 1 and 2 = 6 days)|The PK Population included all participants who received at least 1 dose of study drug and had at least 1 evaluable postdose PK sample.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2525701|NCT03796260|Primary|Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite|The area under the concentration-time curve calculated from Hour 0 to the last measurable concentration, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern.|At pre-defined intervals from study Day 1 through Day 5 of each Period (Periods 1 and 2 = 6 days)|The PK Population included all participants who received at least 1 dose of study drug and had at least 1 evaluable postdose PK sample.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2525702|NCT03796260|Primary|Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of Entrectinib and M5 Metabolite|The area under the concentration-time curve extrapolated to infinity is calculated using the formula: AUC0-inf = AUC0-t + (Ct/λz) where Ct is the last measurable concentration and λz is the apparent terminal elimination rate constant. The presented values in the table are based on all 14 participants receiving the F1 formulation in a 2-way crossover pattern.|At pre-defined intervals from study Day 1 through Day 5 of each Period (Periods 1 and 2 = 6 days)|The PK Population included all participants who received at least 1 dose of study drug and had at least 1 evaluable postdose pharmacokinetic (PK) sample.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2525703|NCT03796182|Secondary|Percentage of Participants With Treatment-Emergent AEs and SAEs (All Causalities and Treatment-related)|AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Day 1 up to Day 40 (35 days after the last dose of metformin)|This analysis population was defined as all participants randomly assigned to investigational product and who took at least 1 dose of investigational product.|||percentage of participants|||Number
2525704|NCT03796182|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related)|AEs with all causalities were any untoward medical occurrences in a study subject administered a product or medical device which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Day 1 up to Day 40 (35 days after the last dose of metformin)|This analysis population was defined as all participants randomly assigned to investigational product and who took at least 1 dose of investigational product.|||Participants|||Count of Participants
2525705|NCT03796182|Secondary|Number of Participants With Categorical Vital Signs Meeting Pre-defined Criteria|Criteria for change in vital signs: pulse rate value less than (<) 40 beats per minute (bpm) or value over than (>) 120 bpm, systolic blood pressure (SBP) value < 90 millimeter of mercury (mmHg) or change from baseline (Chg) equal to or over than (≥) 30 mmHg increase or ≥ Chg 30 mmHg decrease, diastolic blood pressure (DBP) value < 50 mmHg or Chg ≥ 20 mmHg increase or Chg ≥ 20 mmHg decrease.|Screening (within 28 days prior to Day 1) to Day 7|This analysis population was defined as all participants randomly assigned to investigational product and who took at least 1 dose of investigational product.|||Participants|||Count of Participants
2525894|NCT03752567|Secondary|Levels of HbA1c|variation of HbA1c levels (%) when the patient is followed by the community pharmacist as a case manager, as a result of greater adherence to therapy|12 months||||percentage of change||Standard Deviation|Mean
2525706|NCT03796182|Secondary|Number of Participants With Laboratory Abnormalities|Laboratory parameters included: hematology (hemoglobin, hematocrit, erythrocytes, ery. mean corpuscular volume, ery. mean corpuscular hemoglobin, ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time, prothrombin intl. normalized ratio, large unstained cells/leukocytes and large unstained cells), clinical chemistry (bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, sodium, potassium, chloride, calcium, bicarbonate, urobilinogen and glucose -FASTING), urinalysis (specific gravity, pH, urine glucose, ketones, urine protein, urine hemoglobin, urine bilirubin, nitrite and leukocytes). Clinical significance of laboratory parameters is determined at the investigator's discretion.|Screening (within 28 days prior to Day 1) to Day 7|This analysis population was defined as all participants randomly assigned to investigational product and who took at least 1 dose of investigational product.|||Participants|||Count of Participants
2525707|NCT03796182|Secondary|Percent of Dose Recovered Unchanged in Urine From 0 to 24 Hours (Ae%) of Metformin|Ae% is percent of dose recovered unchanged in urine from 0 to 24 hours post-dose of metformin.|For both Period 1 and Period 2 at intervals of 0-12 and 12-24 hours post metformin dose|This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure.|||percentage of dose||Full Range|Median
2525708|NCT03796182|Secondary|Cumulative Amount of Drug Recovered Unchanged in Urine From 0 to 48 Hours (Ae) of Metformin|Ae is the cumulative amount of drug recovered unchanged in urine during the dosing interval. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram [g]/1.020), where 1.020 g/mL is the approximate specific gravity of urine.|For both Period 1 and Period 2 at intervals of 0-12, 12-24, 24-36, and 36-48 hours post metformin dose|This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure.|||milligram (mg)||Full Range|Median
2525709|NCT03796182|Secondary|Terminal Half-life (t1/2) of Metformin|t1/2 is the time measured for the plasma concentration to decrease by one half.|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2|This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure.|||hrs||Standard Deviation|Mean
2525710|NCT03796182|Secondary|Apparent Volume of Distribution (Vz/F) of Metformin|Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2|This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure.|||liter (L)||Geometric Coefficient of Variation|Geometric Mean
2525711|NCT03796182|Secondary|Apparent Clearance (CL/F) of Metformin|CL/F is a quantitative measure of the rate at which drug was removed from the blood.|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2|This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2525712|NCT03796182|Secondary|Area Under the Plasma Concentration Time Profile From Time 0 to the Time of Last Quantifiable Concentration (AUClast) of Metformin|AUClast of metformin administrated with or without PF-04965842.|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2|This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2525713|NCT03796182|Secondary|Time for Cmax (Tmax) of Metformin|Tmax of metformin administrated with or without PF-04965842.|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2|This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Hours (hrs)||Full Range|Median
2525714|NCT03796182|Secondary|Maximum Plasma Concentration (Cmax) of Metformin|Cmax is maximum observed plasma concentration.|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2|This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2525715|NCT03796182|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Metformin|AUCinf is a measure of the serum concentration of the drug over time. It was used to characterize drug absorption.|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose of metformin on Day 1 for both Period 1 and Period 2|This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2525716|NCT03796182|Primary|Renal Clearance (CLr) of Metformin|CLr was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau).|For both Period 1 and Period 2 at intervals of 0-12, 12-24, 24-36, and 36-48 hours post metformin dose|This analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Overall number of participants analyzed referred to participants evaluable for this outcome measure.|||litre per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2525717|NCT03796013|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline through the end of study (up to clinical cut-off date 06 Feb 2019 [28 days])|The Safety Population consisted of all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||Percentage of Participants|||Number
2525718|NCT03796013|Primary|Maximum Observed Concentration (Cmax) of Entrectinib and M5 Metabolite||At pre-defined intervals from Hour 0 through Day 5 of each study Period (Periods 1 and 2 = 6 days)|The PK Population consisted of all participants who received at least 1 dose of study drug and had at least 1 evaluable postdose PK sample.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2525719|NCT03796013|Primary|Area Under the Concentration-Time Curve (AUC0-t) of Entrectinib and M5 Metabolite||At pre-defined intervals from Hour 0 through Day 5 of each study Period (Periods 1 and 2 = 6 days)|The PK Population consisted of all participants who received at least 1 dose of study drug and had at least 1 evaluable postdose pharmacokinetic (PK) sample.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2525720|NCT03793751|Secondary|Any Adverse Outcome|Observation for any adverse effects|0-7 days|Insidence of adverse outcomes|||number of cases||Standard Deviation|Mean
2525721|NCT03793751|Secondary|Heart Rate|Intraoperative Heart Rate|Measured every 10 minutes upto 80 minutes, T0 as the initial reading.|Intraoperative heart rate|||Beats/minute||Standard Deviation|Mean
2525722|NCT03793751|Secondary|Diastolic Blood Pressure|Intraoperative Diastolic Blood Pressure|Measured every 10 minutes upto 80 minutes, T0 as the initial reading.|Diastolic Blood Pressure|||mmHg||Standard Deviation|Mean
2525723|NCT03793751|Secondary|Systolic Blood Pressure|Intraoperative Systolic Blood Pressure|Measured every 10 minutes upto 80 minutes, T0 as the initial reading.|Intraoperative Systolic Blood Pressure|||mmHg||Standard Deviation|Mean
2525724|NCT03793751|Primary|Number of Cases Developing POCD|"Number of cases developing POCD in the Dexmedetomidine Group as compared to the placebo group using the Montreal Cognitive Assessment (MoCA) test. The Montreal Cognitive Assessment (MoCA) test is a free assessment available at http://www.mocatest.org tool designed for quick screening for mild cognitive impairment. It is a one page, 30 point test done in approximately 10 min for assessment of attention, memory, abstraction, delayed recall and orientation, with total score of 30. MoCA range from zero to 30, with a score of 26 and higher generally considered normal. Scores below 26 were considered as Postoperative Cognitive Dysfunction."|0-7 days||||Participants|||Count of Participants
2525725|NCT03793556|Secondary|Patients'Satisfaction|This evaluation was expressed with a semi-quantitative ordinal scale: 0 = low, 1 = discrete, 2 = good, 3 = excellent).|At visit 4 after weeks of treatment|Four patients in the GERFOFF + omeprazole group did not complete the Reflux Symptom Index questionnaire and could not be included in the analysis.|||Participants|||Count of Participants
2525726|NCT03793556|Secondary|Use of Rescue Medication (Other Than Omeprazole) During Treatment|During treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.|From baseline to visit 4||||Participants|||Count of Participants
2525727|NCT03793556|Secondary|Use of Rescue Medication (Omeprazole) During the Follow-up|During the follow-up, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.|In the Visit 6 after 12 weeks from baseline||||Participants|||Count of Participants
2525728|NCT03793556|Secondary|Use of Rescue Medication (Omeprazole) During the Treatment|In the first 6 weeks of treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug and the comparison between groups was performed using the Fisher's exact test.|From baseline to visit 4||||Participants|||Count of Participants
2525729|NCT03793556|Secondary|Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire|The Reflux Symptom Index questionnaire examines 9 items, to be scored from 0 to 5, with a higher score indication a higher severity of the symptom (range of total score: 0-45).|At visit 4 after weeks of treatment||||Participants|||Count of Participants
2525730|NCT03793556|Secondary|Score of Upper Symptoms Using the Likert Scale at Baseline and in the Visit V4|"The Likert scale examines 9 symptoms, to be scored from 0 to 4, with a higher score indication a higher frequency of the symptom (i.e. 0=never, 1=occasionally, 2=sometimes, 3= often, 4=Always);~The Likert scale scores of single items are as following:~Hoarseness or vocal problem 0 1 2 3 4~Throat clearance 0 1 2 3 4~Excess of mucus in the throat or retrosternal fall of secretions 0 1 2 3 4~Difficulty in swallowing food, fluids or pills 0 1 2 3 4~Cough after the meal or after lying 0 1 2 3 4~Difficulty in breathing or episodes of choking 0 1 2 3 4~Problematic or troublesome cough 0 1 2 3 4~Sensation of something blocked or mass in the throat 0 1 2 3 4~Stomach burning, thoracic pain, poor digestion of gastric acid that moves upright 0 1 2 3 4.~Subscales are summarized to compute a total score (total score ranges from 0-36). The mean values of Likert scale total score are reported."|At baseline and in the visit 4||||Score on a scale||Standard Deviation|Mean
2525731|NCT03793556|Secondary|Number of Responders V6|"Responder patients of Group Gerdoff® + omeprazole were randomly assigned to receive a treatment with Gerdoff®-one tablet three times daily- All patients received a packaging of omeprazole, to be taken only if necessary, at constant dose and according to the indications of the Investigator. The scheduled duration of the follow-up period was 12 weeks.~A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value < 13 on the RSI questionnaire."|In the Visit 6 at the end of follow-up||||Participants|||Count of Participants
2525732|NCT03793556|Secondary|Number of Responders V4|A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value < 13 on the RSI questionnaire.|At visit 4 after 6 weeks of treatment||||Participants|||Count of Participants
2525895|NCT03752567|Secondary|Levels of Arterial Pressure|variation of arterial pressure (Systolic, Diastolic) (mmHg)|12 months||||percentage of change||Standard Deviation|Mean
2525733|NCT03793556|Secondary|Score of Stomach Burning, Thoracic Pain, Poor Digestion of Gastric Acid That Moves Upright of the RSI Questionnaire Measured at Baseline and in the Visit 4|The Reflux Symptom Index questionnaire examines 9 items, including stomach burning, thoracic pain, poor digestion of gastric acid that moves upright that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.|At baseline and in the visit 4, after 6 weeks of treatment||||Score on a scale||Standard Deviation|Mean
2525734|NCT03793556|Secondary|Score of Sensation of Something Blocked or Mass in the Throat of the RSI Questionnaire Measured at Baseline and in the Visit 4|The Reflux Symptom Index questionnaire examines 9 items, including sensation of something blocked or mass in the throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.|At baseline and in the visit 4, after 6 weeks of treatment||||score on a scale||Standard Deviation|Mean
2525735|NCT03793556|Secondary|Score of Problematic or Troublesome Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4|The Reflux Symptom Index questionnaire examines 9 items, including problematic or troublesome cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.|At baseline and in the visit 4, after 6 weeks of treatment||||score on a scale||Standard Deviation|Mean
2525736|NCT03793556|Secondary|Score of Difficulty in Breathing or Episodes of Choking of the RSI Questionnaire Measured at Baseline and in the Visit 4|The Reflux Symptom Index questionnaire examines 9 items, including difficulty in breathing or episodes of choking that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.|At baseline and in the visit 4, after 6 weeks of treatment||||score on a scale||Standard Deviation|Mean
2525737|NCT03793556|Secondary|Score of Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4 After the Meal or After Lying|The Reflux Symptom Index questionnaire examines 9 items, including cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.|At baseline and in the visit 4, after 6 weeks of treatment||||score on a scale||Standard Deviation|Mean
2525738|NCT03793556|Secondary|Score of Difficulty in Swallowing Food, Fluids or Pills of the RSI Questionnaire Measured at Baseline and in the Visit 4|The Reflux Symptom Index questionnaire examines 9 items, including difficulty in swallowing food, fluids or pills that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.|At baseline and in the visit 4, after 6 weeks of treatment||||score on a scale||Standard Deviation|Mean
2525739|NCT03793556|Secondary|Score of Excess of Mucus in the Throat or Retrosternal Fall of Secretions of the RSI Questionnaire Measured at Baseline and in the Visit 4|The Reflux Symptom Index questionnaire examines 9 items, including excess of mucus in the throat or retrosternal fall of secretions that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.|At baseline and in the visit 4, after 6 weeks of treatment||||score on a scale||Standard Deviation|Mean
2525740|NCT03793556|Secondary|Score of Throat of the RSI Questionnarie Measured at the Baseline and in the Visit 4 of the RSI Questionnaire Score of Throat Clearance|The Reflux Symptom Index questionnaire examines 9 items, including throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.|At baseline and in the visit 4, after 6 weeks of treatment||||score on a scale||Standard Deviation|Mean
2525741|NCT03793556|Secondary|Score of Hoarseness or Vocal Problem of the RSI Questionnaire Measured at the Baseline and in the Visit 4|The Reflux Symptom Index questionnaire examines 9 items, including hoarseness or vocal problem that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.|At baseline and in the visit 4, after 6 weeks of treatment||||score on a scale||Standard Deviation|Mean
2525742|NCT03793556|Secondary|Total Score of Reflux Symptom Index Questionnaire in All Time-points Assessed|"Total score of the Reflux Symptom Index questionnaire assessed in all time-points.~The RSI questionnaire examines 9 items, that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45)."|In baseline Visit, Visit 2 (after 1 week), Visit 3 (after 3 weeks) and Visit 4 (after 6 weeks of treatment)|Some data are missing; therefore, the number of participants in one or more rows differs from overall number analyzed.|||score on a scale||Standard Deviation|Mean
2525743|NCT03793556|Primary|Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire|After 6 weeks of treatment, the changes from baseline in the score of Reflux Symptom Index questionnaire were evaluated to verify the effects of treatments on high symptoms. The RSI questionnaire examines 9 items that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).|In the first visit (baseline) and in the visit 4 (after 6 weeks of treatment)|Four patients in the GERFOFF + omeprazole group did not complete the Reflux Symptom Index questionnaire and could not be included in the analysis.|||Score on a scale||Standard Deviation|Mean
2525744|NCT03790306|Secondary|Number of Patients Who Return to Driving 6 Weeks After Surgery|Patients will respond yes or no when asked if they have resumed driving.|6 Weeks||||Participants|||Count of Participants
2525745|NCT03790306|Secondary|Number of Patients That Return to Work 6 Weeks After Surgery|"questionnaire asking the patient to report whether or not they have returned to employment and at what capacity (using Department of Labor physical employment scale). Patients will answer yes or no when asked if they have returned to work."|6 weeks||||Participants|||Count of Participants
2525746|NCT03790306|Secondary|Hip Dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR)|Assesses three domains (pain, daily living activity, stiffness). The HOOS, JR contains 6 items, coded from 0-4(none to extreme). The HOOS, JR is scored by summing the raw response (ranging from 0-24) and then converting it to an interval score. The interval scores range from 0-100 where 0 represents total hip disability and 100 represents perfect hip health.|6 Weeks||||score on a scale||Standard Deviation|Mean
2525747|NCT03790306|Secondary|Length of Stay in Hospital|Average number of days in hospital after surgery|1 week||||days||Full Range|Mean
2525748|NCT03790306|Secondary|Number of Participants Who Adhere to Prescribed Post op Recovery Protocol|Number of Participants Who Adhere to Prescribed Post op Recovery Protocol collected via a questionnaire|2 weeks||||Participants|||Count of Participants
2525749|NCT03790306|Secondary|Sleep Quality|The percentage of patients where pain interrupts sleep 'never' or 'rarely' will be combined together and reported.|6 Weeks||||Participants|||Count of Participants
2527975|NCT03535844|Secondary|Change in Blood Pressure|Both systolic and diastolic blood pressure|Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported||||mmHg||Standard Deviation|Mean
2525750|NCT03790306|Secondary|Numeric Pain Scores|A numeric pain score (0-10, 0 is no pain and 10 is worst imaginable pain). This will be used to assess patients level of pain relating to opioid use and recovery. Both 'best' pain level and 'worst' pain level as reported by the patient will be reported.|6 Weeks||||units on a scale||Standard Deviation|Mean
2525751|NCT03790306|Primary|Short Physical Performance Battery|Assessment tool measuring gait speed, balance and chair stand test. Scores range from 0 to 4 with higher scores indicating a better outcome.|6 Weeks||||score on a scale||Standard Deviation|Mean
2525752|NCT03790306|Primary|Number of Patients That Took Any Opioids Throughout 6-week Follow-up Period|Number of patients that took any opioids throughout 6-week follow-up period|6 weeks||||Participants|||Count of Participants
2525753|NCT03790306|Primary|Pre-operative Narcotic Use|Percentage of patients that used used opioids pre-operatively|Pre-operatively||||Participants|||Count of Participants
2525754|NCT03787212|Primary|Posterior Eyelid Temperature (Palpebral Conjunctiva)|Ocular surface temperature is usually 34.03±0.51ºC in the normal eye. The temperature required to melt obstructive secretions in the Meibomian glands ranges from 32- 35°C but the more severely obstructed glands present in MGD could require a temperature of >40°C, for effective treatment. there is an approximate 5°C difference in temperature between heat applied on the external eyelid surfaces and that reaches the inner surface of the lids, where the meibomian glands are located. This difference was due to both dissipation of heat while passing through the lid tissues and to constant movement of blood through vasculature wicking heat away from the lids. Therefore, achieving the desired temperature of 40°C at the palpebral conjunctiva requires a constant heat of at least 45°C be maintained on the outer lid surface, a temperature which could be both uncomfortable and risk causing thermal injury to the eyelid skin.|12-minutes post treatment|All subjects that completed all study visits and did not had a protocol deviation impacting a primary endpoint.|||Celcius|eyes|Standard Deviation|Mean
2525755|NCT03783780|Secondary|Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Motion|Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value during motion.|1-5 hours|Ten subjects were excluded from data analysis from this outcome measure due to insufficient training of the study staff on the motion testing procedure.|||% of oxygen saturated hemoglobin|||Number
2525756|NCT03783780|Primary|Oxygen Saturation (SpO2) Accuracy of Sensor by Arms Calculation During Non-motion|Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Arithmetic root mean square (ARMS) value during non-motion.|1-5 hours|Only ten subjects, out of the 20 who participated in the study, underwent testing for this non-motion outcome measure.|||% of oxygen saturated hemoglobin|||Number
2525757|NCT03782181|Primary|Quality of Life Index (QLI)|The Quality of Life Index (QLI) is a self-report questionnaire that measures perceived health-related quality of life. We used the total score of QLI. Its scale is scored by simply adding the score on each item. The range of scores is between 15 to 105, with a higher score or number being indicative of a higher quality of life. An average total rating for a healthy person is usually around 90, whereas a low quality of life measures around 15.|10 minutes|Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).|||units on a scale||Standard Deviation|Mean
2525758|NCT03782181|Primary|Visual Analogue Pain Scale (VAS)|Each participant was asked to indicate their current level of pain using a 20 cm VAS that ranged from 0 (no pain) to 100 (highest level of pain).|5 minutes|Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).|||units on a scale||Standard Deviation|Mean
2525759|NCT03782181|Primary|Fibromyalgia Impact Questionnaire (FIQ)|The Fibromyalgia Impact Questionnaire (FIQ) is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. It has been designed to measure the components of health status that are believed to be most affected by fibromyalgia. The FIQ is a self administered instrument that takes approximately 5 minutes to complete. The directions are simple and the scoring is self-explanatory. The FIQ is scored in such a way that a higher score indicates a greater impact of the syndrome on the person. Each of the 10 items has a maximum possible score of 10. Thus the maximum possible score is 100. The average FM patient scores about 50, severely afflicted patients are usually 70 plus.|5 minutes|Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).|||Units on a scale||Standard Deviation|Mean
2525760|NCT03782181|Primary|Gait Task|Subjects were instructed to walk on a 4 meters carpet at their normal walking step, with shocks and with flexed arms positioned on the abdomen. Optical markers were attached at the following three body positions: area between the lateral condyle of the femur and the fibular head, great trochanter and lateral malleolus. Subject's motion was digitally recorded with a video camera at 210 frames per second (CasioExilimEX-FS10). The camera was positioned at a distance of 4 meters from the carpet to visualize changes in position, velocity and anatomical points along the x-axis. It was calculated the stride length by an open- source software for computer vision analysis of human movement.|5 minutes|Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).|||Meters||Standard Deviation|Mean
2525761|NCT03782181|Primary|Analysis of the Romberg's Balance Test With the CvMob Software|The CvMob is an Open Source tool for the movement analysis. The software is capable to analyse the trajectories and to determinate the kinematic variables from a movie, that can be done with a simple camera. The tool includes the Movement Elements Decomposition Method (MED).In the present study, we analyzed the oscillatory body movements during the test performance. These ocillatory movements should be minimal with good balance.The patients were asked to remain in orthostatic position with feet parallel at shoulder height, arms extended along the body and eyes closed for 1 minute. A body marker is placed on the patient's head. A camera placed on the ceiling records the movements. Subsequently, the software analyzes and decomposes the movement that the patient has described in the anteroposterior and mediolateral axis. Higher values represent a worse outcome.|1 minute|Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).|||Centimeters||Standard Deviation|Mean
2526578|NCT03657407|Primary|Post-operative Pain: VAS|Visual analog pain scale (VAS) (0 to 10, 0 = no pain, 10 = maximum pain), averaged over duration of PACU stay until discharge criteria met|up to 4 hours||||score on a scale||Standard Deviation|Mean
2525763|NCT03782181|Primary|Six-minute Walking Test (6MWT)|The 6MWT is a functional test in which the patient walks what he can during 6 minutes, analyzing the total distance walked.|6 minutes|Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).|||Metres||Standard Deviation|Mean
2525764|NCT03782181|Primary|Berg Scale|This is a functional balance assessment tool, consisting of 14 functional tasks with values ranging from 0 (cannot perform) to 4 (normal performance). The general scores range from 0 (severely impaired balance) to 56 (excellent balance). The Berg scale has been previously used in patients with fibromyalgia to assess balance.|30 minutes|Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).|||units on a scale||Standard Deviation|Mean
2525765|NCT03782181|Primary|Vibration Thresholds|Vibration thresholds at the great toes and at the index fingers were quantified bilaterally using a Vibratron II (Physitemp, Clifton, USA). Using a two‐alternative forced‐choice procedure, subjects identified which of two rods was vibrating. Vibration values displayed on the control unit are vibration units (the amplitude of vibration, proportional to the square of applied voltage). Vibration threshold for the index finger in the normal population between 18 and 65 years of age is 0.7 vibration units with a standard deviation of 0.4 vibration units. The vibration threshold for the great toe in a similar population is 1.2 vibration units with a standard deviation of 0.5 vibration units. There is an increase in threshold scores and in variance as a function of age. There is an increase in threshold scores and variance depending on age. When the vibratory threshold is lower, it indicates the patient's greater ability to detect vibratory stimuli.|20 minutes|Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).|||Hertz||Standard Deviation|Mean
2525766|NCT03782181|Primary|Pressure Pain Thresholds|Pressure stimuli were applied on two bilateral body locations: epicondyles and index finger. The pressure pain threshold was defined as the pressure value considered as painful by the participant.|20 minutes|Patients diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology (n=40).|||Newton/centimeter² (N/cm²)||Standard Deviation|Mean
2525767|NCT03781375|Secondary|Percentage of Participants With a 70% Improvement in JRA DOI at Month 6|"Response was defined using the JRA definition of improvement (JRA DOI) as a ≥ 70% improvement from baseline in at least three of the six JRA Core Set Criteria and ≥ 30% worsening in not more than one of the six assessments. The JRA Core Set Criteria consist of:~Physician's global assessment of disease severity assessed on a visual analog scale (VAS) from 1 to 10~Patient's/Parent's global assessment of overall well being assessed on a VAS from 1 to 10~Number of active joints (swelling, not due to deformity, or if no swelling is present, limitation of motion accompanied by pain on passive motion and/or tenderness and/or warmth)~Number of joints with limitation of motion~Childhood Health Assessment Questionnaire (CHAQ)~Erythrocyte sedimentation rate (ESR)"|Baseline and month 6|All randomized participants; participants with missing data were counted as non-responders.|||percentage of participants|||Number
2525768|NCT03781375|Secondary|Percentage of Participants With a 50% Improvement in JRA DOI at Month 6|"Response was defined using the JRA definition of improvement (JRA DOI) as a ≥ 50% improvement from baseline in at least three of the six JRA Core Set Criteria and ≥ 30% worsening in not more than one of the six assessments. The JRA Core Set Criteria consist of:~Physician's global assessment of disease severity assessed on a visual analog scale (VAS) from 1 to 10~Patient's/Parent's global assessment of overall well being assessed on a VAS from 1 to 10~Number of active joints (swelling, not due to deformity, or if no swelling is present, limitation of motion accompanied by pain on passive motion and/or tenderness and/or warmth)~Number of joints with limitation of motion~Childhood Health Assessment Questionnaire (CHAQ)~Erythrocyte sedimentation rate (ESR)"|Baseline and month 6|All randomized participants; participants with missing data were counted as non-responders.|||percentage of participants|||Number
2525769|NCT03781375|Primary|Percentage of Participants With a JRA Response at Month 6|"Response was defined using the JRA definition of improvement (JRA DOI) as a ≥ 30% improvement from baseline in at least three of the six JRA Core Set Criteria and ≥ 30% worsening in not more than one of the six assessments. The JRA Core Set Criteria consist of:~Physician's global assessment of disease severity assessed on a visual analog scale (VAS) from 1 to 10~Patient's/Parent's global assessment of overall well being assessed on a VAS from 1 to 10~Number of active joints (swelling, not due to deformity, or if no swelling is present, limitation of motion accompanied by pain on passive motion and/or tenderness and/or warmth)~Number of joints with limitation of motion~Childhood Health Assessment Questionnaire (CHAQ)~Erythrocyte sedimentation rate (ESR)"|Baseline and month 6|All randomized participants; participants with missing data are counted as non-responders.|||percentage of participants|||Number
2525770|NCT03780959|Secondary|Number of Participants With Adverse Events||Part 1: 90 days (months 1-3) plus 30 days for participants who were not randomized into part 2. Part 2: From first dose of randomized treatment to 30 days after last dose (150 days; months 4-8).|All participants who received at least one dose of study drug|||Participants|||Count of Participants
2525771|NCT03780959|Secondary|Time to Flare in Part 2|The time from day 90 to flare. Participants who withdrew without flare were censored at the time of withdrawal.|Months 4 to 7|All randomized participants|||days||Full Range|Median
2525772|NCT03780959|Primary|Percentage of Participants With Disease Flare in Part 2|"Disease flare was defined as a 30% or greater worsening in three of the six JRA Core Set Criteria and ≥ 30% improvement in one or less of the six JRA Core Set Criteria compared to day 90 and a minimum of two active joints (joints with swelling or limitation of movement plus pain and/or tenderness).~The JRA Core Set criteria consisted of:~Physician global assessment of disease severity assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms);~Patient/parent global assessment of overall well-being assesses on a VAS from 0 (asymptomatic) to 10 (severe symptoms);~Number of active joints;~Number of joints with limitation of motion (LOM) and with pain, tenderness, or both;~Childhood Health Assessment Questionnaire (CHAQ) disability domain;~Erythrocyte sedimentation rate (ESR)."|End of part 1 (day 90) and months 4 to 7|All randomized participants|||percentage of participants|||Number
2525773|NCT03780010|Secondary|Number of Patients Who Have TRC105 Positive Anti-Product Antibodies|Anti-product antibody concentrations will be measured using validated ELISA methods. Anti-product antibody concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles.|6 months|All patients who received at least a portion of a dose of TRC105 with immunogenicity samples collected at baseline and at least 1 time point on study|||Participants|||Count of Participants
2525774|NCT03780010|Secondary|Pharmacokinetic Profile of TRC105 When Given With Bevacizumab and Paclitaxel/Carboplatin|Trough serum TRC105 pharmacokinetic concentrations at steady state (cycle 3 day 1) will be measured using validated ELISA methods.|3 months|All patients who received at least a portion of a dose of TRC105 with PK samples collected at baseline and at least 1 time point on study|||ng/mL||Full Range|Mean
2525775|NCT03780010|Secondary|Median Progression Free Survival|Median duration of progression free survival according to RECIST 1.1 criteria|months|Number of patients progression free according to RECIST 1.1 after 6 months of treatment|||Months||Standard Deviation|Median
2525776|NCT03780010|Secondary|Percent of Patients With Progression-free Survival (PFS) at 6 Months|Number of patients with progression-free survival at 6 months determined according to RECIST 1.1 criteria|6 months|Number of patients progression free according to RECIST 1.1 after 6 months of treatment|||Participants|||Count of Participants
2525777|NCT03780010|Secondary|Overall RECIST 1.1 Response Rate|Response rate determined according to RECIST 1.1 criteria|6 months|Number of patients with a baseline scan and at least 1 on study scan were evaluable for response rate determination|||Participants|||Count of Participants
2525778|NCT03780010|Primary|Treatment-Emergent Adverse Events|Incidence of treatment-emergent (i.e. TRC105, bevacizumab, paclitaxel and/or carboplatin) adverse events by CTCAE v4.03|from screening until completion of follow-up, on average 6 months|All patients who received at least a portion of a dose of any study drug (TRC105, Bevacizumab or Paclitaxel/Carboplatin)|||Participants|||Count of Participants
2525779|NCT03779724|Primary|Visual Analog Scale|Pain intensity was evaluated with the Visual Analog Scale. Using a ruler, a 10 cm line was drawn which provided a range of scores from 0-100. Than the patients marked the point that showed their pain intensity on this line. A higher score in Visual Analog Scale indicates greater pain intensity.|At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment||||score on a scale||Standard Deviation|Mean
2525780|NCT03779724|Primary|Multiple Sclerosis Quality of Life-54 Total Score, Physical and Emotional Composite Scores, and Pain Subscale Score|This is a multidimensional health-related quality of life measure that combines both generic and multiple sclerosis-specific symptoms in a single instrument. The 54 items are divided into 12 multi-item and 2 single-item scales.Health distress, overall quality of life, emotional well-being, role limitations-emotional and cognitive funtion items' final scores averaged and mental composite score was calculated. Physical function, health perceptions, energy/fatigue, role limitations-physical, pain, sexual function, social function, health distress items' final scores were averaged and physical composite score was obtained.Total score was obtained by averaging the mental and physical composite scores.Final scores can be between 0-100 points for total, mental, physical and pain scores. Higher values indicate better quality of life for total, physical and mental scores and worser pain levels for pain score.|At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment||||score on a scale||Standard Deviation|Mean
2525781|NCT03779724|Primary|Tampa Scale of Kinesiophobia|Kinesiophobia which is described as fear of movement and physical activity was evaluated using the Tampa Scale of Kinesiophobia, which is a 17-item self-report survey. The range of scores are from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia. If the total score was above 37 points, the patient was considered to have a high level of kinesiophobia.|At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment||||score on a scale||Standard Deviation|Mean
2525782|NCT03779724|Primary|Joint Position Sense of the More and Less Affected Knees|Absolute angular errors of the 15°, 45°, and 60° and the mean absolute angular error of the more and less affected knees were measured by an isokinetic dynamometer (Biodex Multijoint Pro 3) with active-active angular reproduction method. Estimating the target angel procedure was repeated at 45°, 15°, and 60° and for both the more and less affected legs. After the joint position sense testing, three angles estimated by the patients were averaged, and the angular error was calculated for each target angle. Absolute angular error was calculated by averaging the angular errors, regardless of the numbers being negative or positive. The absolute angular error values of the three target angles were averaged to obtain the mean absolute angular errors. A definite angular error value has not been defined. Literally, healthy controls and patients are compared. Higher scores indicate worser joint position sense.|At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment||||degree||Standard Deviation|Mean
2525783|NCT03779724|Primary|Isokinetic Muscle Strength Test of the More and Less Affected Knees|The peak torque/body mass index of the quadriceps and hamstring muscles at 60°/s and 180°/s velocities were measured by an isokinetic dynamometer (Biodex Multijoint Pro 3) in Newton/meter. A definite muscle strength value has not been defined. Literally, healthy controls and patients are compared. Higher scores indicate better muscle strength.|At baseline (10 minutes before the start of the treatment) and 8 weeks after start of the treatment||||Newton/meter||Standard Deviation|Mean
2525784|NCT03777865|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. Treatment-emergent were events between first dose of study drug and up to 1 month that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.|up to 1 month after vaccination on Day 1|The safety population included all participants who received 1 dose of an investigational product.|||percentage of participants||95% Confidence Interval|Number
2525810|NCT03765502|Secondary|Average Time for Untrained Users to Successfully Administer One Device Over the Other|Average time for untrained users who found both devices to successfully administer one rescue device over the other in Part B. To successfully administer either NG or GEK, a participant must complete all of the critical steps for each device, and administer a complete dose.|Part B: Day 1 and Days 8-9|All untrained user participants who found both devices and completed at least one successful rescue device simulation.|||seconds||Standard Deviation|Mean
2525991|NCT03725098|Primary|3 Minute Hemostasis - Hemostatic Success (Yes/no) at 3 Minutes|The primary endpoint of this study is the superiority of HEMOBLAST™ relative to FLOSEAL for the proportion of subjects reaching hemostasis within 3 minutes.|Intraoperative||||Participants|||Count of Participants
2525785|NCT03777865|Primary|Percentage of Participants Reporting Systemic Events by Severity Within 7 Days After Vaccination|Systemic events included fever, fatigue(tiredness), headache, muscle pain, joint pain, vomiting and diarrhea. Fever: greater than or equal to (>=) 38.0 degrees Celsius (C), >=38.0 degrees C to <=38.4 degrees C, >=38.5 to <=38.9 degrees C, 39.0 to 40.0 degrees C, > 40.0 degrees C. Fatigue, headache, muscle pain and joint pain graded as any (any fatigue, headache, muscle pain, joint pain), mild(did not interfere with activity), moderate(some interference with activity) or severe(prevented daily routine activity). Vomiting was graded as any (any vomiting), mild (1-2 times in 24 hours [hrs.]), moderate(>2 times in 24 hrs.) or severe (required intravenous hydration). Diarrhea was graded as any(any diarrhea), mild (2-3 loose stools in 24 hrs.), moderate(4-5 loose stools in 24 hrs.) or severe(>=6 loose stools in 24 hrs.)|Within 7 days after vaccination on Day 1 (up to Day 7)|The safety population included all participants who received 1 dose of an investigational product. Here “Overall Number of Participants Analyzed”=Participants evaluable for this outcome measure and “Number Analyzed”=Participants evaluable at specific rows.|||percentage of participants||95% Confidence Interval|Number
2525786|NCT03777865|Primary|Percentage of Participants Reporting Local Reactions by Severity Within 7 Days After Vaccination|Local reactions (redness, swelling and pain [tenderness]) at the 13vPnC injection site were monitored daily for 7 days after vaccination. Redness and swelling were measured and recorded in a measuring device units. 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as; any (any redness or swelling at the injection site), mild (1 to 4 measuring device units = 0.5 to 2.0 cm), moderate (5 to 14 measuring device units = 2.5 to 7.0 cm) and severe (greater than [>]14 measuring device units = >7.0 cm). Pain (tenderness) at injection site was categorized as; any: any pain at the injection site, mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.|Within 7 days after vaccination on Day 1 (up to Day 7)|"The safety population included all participants who received 1 dose of an investigational product. Here, “Overall Number of Participants Analyzed”=Participants evaluable for this outcome measure and “Number Analyzed=Participants evaluable at specific rows."|||percentage of participants||95% Confidence Interval|Number
2525787|NCT03774745|Secondary|Number of Participants With Change in Serum Progesterone and hCG During Follow-up|Change in serum progesterone and hCG during follow-up evaluation|up to 16 days after mifepristone administration|intent to treat|||participants|||Number
2525788|NCT03774745|Secondary|Medical Safety During Treatment and Follow-up|Adverse events related to morbidity, e.g. hemorrhage, emergency department visits, emergent dilation and curettage procedures|up to 16 days after mifepristone administration|intent to treat|||participants|||Number
2525789|NCT03774745|Secondary|Number of Participants With Adverse Events During Follow-up Evaluation|Side effects from progesterone/placebo treatment and ability to continued treatment as prescribed|up to 16 days after mifepristone administration|increased to severe at any time during follow-up|||participants|||Number
2525790|NCT03774745|Secondary|Expulsion During Follow-up Evaluation|Pregnancy expulsion following mifepristone treatment|up to 16 days after mifepristone administration|intention to treat|||Participants|||Count of Participants
2525791|NCT03774745|Primary|Continuing Pregnancy Based on Ultrasound Examination|Pregnancy still in uterus with normal growth and gestational cardiac activity present based on ultrasound examination|at 14-16 days after mifepristone administration|Intention to treat|||Participants|||Count of Participants
2525792|NCT03772327|Secondary|Number of Participants Reporting 100% Adherence to Antiretroviral Medications in During to the Prior 4 Days at Week 12.|"Analyze participant's self-reported adherence using National Institutes of Health AIDS Clinical Trials Group (ACTG) standardized and validated questionnaire of number of days with no missed doses of medication over prior 4 days (minimum 0, maximum 4). Number of days with missed doses was dichotomized to no missed doses (100% adherence) and ≥ 1 missed dose."|Week 12|5 and 7 participants dropped out between baseline and week 12 in the AdhereTech bottle arm and routine counseling only arms respectively. One participant in the AdhereTech bottle arm did not fully complete the adherence questionnaire at week 12.|||Participants|||Count of Participants
2525793|NCT03772327|Secondary|TFV-DP Plasma Levels|Assess TFV-DP plasma levels to compare to dried blood spot levels|Baseline and Week 12|Funding was not obtained to obtain TFV-DP plasma levels in the study||||||
2525794|NCT03772327|Secondary|Number of Participants With HIV RNA ≥ 20 Copies/mL at Baseline That Had a Decrease in HIV RNA to < 20 Copies/mL at Week 12 in the AdhereTech Bottle Arm Versus the Routine Counseling Only Arm.|"This is a measure of qualitative HIV RNA outcome. The number of participants converting from detectable (HIV RNA ≥ 20 copies/mL) at baseline to undetectable (HIV RNA < 20 copies/mL) at week 12 in the AdhereTech bottle arm versus the routine counseling only arm."|Baseline and Week 12|5 and 7 participants left the AdhereTech bottle and routine counseling groups respectively. An additional participant in the AdhereTech bottle group is missing the Week 12 HIV viral load.|||Participants|||Count of Participants
2525795|NCT03772327|Secondary|Change in Quantitative HIV Viral Load|Comparative changes in quantitative HIV viral load between baseline and Week 12 in the AdhereTech bottle arm versus the routine counseling only arm.|Baseline and Week 12|5 and 7 participants left the AdhereTech bottle and routine counseling groups respectively. And additional participant in the AdhereTech bottle group is missing the Week 12 HIV viral load.|||copies/mL||Inter-Quartile Range|Median
2525796|NCT03772327|Secondary|Number of Participants Completing the 12 Week AdhereTech Bottle Intervention Compared to the Routine Counseling Only Group.|"Feasibility of using the AdhereTech Smart Pill Bottles in individuals living with HIV as measured by the proportion of participants that complete the study compared between arms. A statistically lower proportion in the AdhereTech bottle arm compared to the routine counseling arm would suggest use of the bottle is not feasible."|Week 12||||Participants|||Count of Participants
2525797|NCT03772327|Primary|Change in Tenofovir Diphosphate (TFV-DP) Drug Levels|Using dried blood spots from red blood cells, TFV-DP levels will be assessed.|Baseline and Week 12|Of the 5 in AdhereTech bottle group missing baseline TFV-DP levels 2 were lost to follow up prior to the visit and 3 are missing levels. 3 participants in AdhereTech group left the study before Week 12. 4 participants in the routine counseling group are missing TFV-DP levels from baseline visit and then 7 left the study prior to Week 12.|||fmol/punch||Inter-Quartile Range|Median
2526056|NCT03717064|Secondary|Period 2: AUC0-inf of Pitavastatin Lactone||Period 2 Day 4||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2553719|NCT02770625|Secondary|Chitotriosidase Level (Nmol/mL/hr)||from baseline to Week 24||||nmol/mL/hr||Standard Deviation|Mean
2525798|NCT03771560|Secondary|Pediatric Quality of Life (PedsQL) - Parent Reported Change|"Pediatric Quality of Life is reported by parent only and it assesses improvement of the child's overall quality of life through questions about physical, emotional, social and school functioning. There are 23 questions. The scoring of PedsQL questions can range from 0 (Never) to 4 (Almost Always) points on a Likert scale. Questions are reversed scored and linearly transformed to a 0 - 100 scale for data analysis as follows: 0=100, 1=75, 2=50, 3=23, 4=0. The total score = sum of all the questions over the number of items answered on. The total possible score range for the PedsQL is 0 - 100. Analysis will be performed for mean of total score change over time.~Scoring from 0 to 4~Never = 0, Almost Never = 1, Sometimes = 2, Often = 3, Almost Always =4~Higher score indicates better performance."|Baseline to Week 12||||score on a scale||95% Confidence Interval|Mean
2525799|NCT03771560|Secondary|Social Responsiveness Scale (SRS) - Teacher Reported Change|"The Social Responsiveness Scale - teacher reported version measures social ability in children and young adults. There are 65 questions. The questions on the scale with anchors 1 (Not True) - 4 (Almost Always True). The scoring of SRS questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total possible score range for the SRS is 0 - 195. Analysis will be performed for mean of total score change over time.~Anchors Not True = 1 Sometimes True = 2 Often True = 3 Almost Always True = 4~Lower score indicates better performance."|Baseline to Week 12|Deleted one outlier for data analysis; deleted one subject because of missing survey time point from teacher.|||score on a scale||95% Confidence Interval|Median
2525800|NCT03771560|Secondary|Social Responsiveness Scale (SRS) - Parent Reported Change|"The Social Responsiveness Scale - parent reported version measures social ability in children and young adults. There are 65 questions. The questions on the scale with anchors 1 (Not True) - 4 (Almost Always True). The scoring of SRS questions can range from 0-3 (with possible reverse scoring) based on scoring instructions for data analysis. The total possible score range for the SRS is 0 - 195. Analysis will be performed for mean of total score change over time.~Anchors Not True = 1 Sometimes True = 2 Often True = 3 Almost Always True = 4~Lower score indicates better performance."|Baseline to Week 12||||score on a scale||95% Confidence Interval|Mean
2525801|NCT03771560|Primary|Aberrant Behavior Checklist (ABC) - Teacher Reported Change|"The Aberrant Behavior Checklist - teacher reported version measures aberrant behavior in children and young adults. There are 58 questions. The scoring of ABC questions can range from 0 (not a problem) to 3 (severe) points on a likert scale. The total possible score range for the ABC is 0 - 174. Analysis will be performed for mean of total score change over time.~Scoring from 0-3~Not a problem = 0, Slightly = 1, Moderately Serious =2, Severe =3~Lower score indicates better performance."|Baseline to Week 12|Deleted one outlier for data analysis; deleted one subject because of missing survey time point from teacher.|||score on a scale||95% Confidence Interval|Mean
2525802|NCT03771560|Primary|Aberrant Behavior Checklist (ABC) - Parent Reported Change|"The Aberrant Behavior Checklist - parent reported version measures aberrant behavior in children and young adults. There are 58 questions.The scoring of one question can range from 0 (not a problem) to 3 (severe) points on a Likert scale. The total possible score range for the ABC is 0 - 174. Analysis will be performed for mean of total score change over time.~Scoring from 0-3~Not a problem = 0, Slightly = 1, Moderately Serious =2, Severe =3~Lower score indicates better performance."|Baseline to Week 12||||score on a scale||95% Confidence Interval|Mean
2525803|NCT03767062|Primary|Attack Frequencies|Number of headaches patients suffer in a month.|Post treatment (4 weeks later)||||headaches per month||Standard Deviation|Mean
2525804|NCT03767062|Primary|Visual Analog Scale|Range Pain 0-10, 0: No pain, 10: Worst Pain|Post treatment (4 weeks later)||||units on a scale||Standard Deviation|Mean
2525805|NCT03766373|Primary|Number of Participants With Adverse Events||1 Day||||Participants|||Count of Participants
2525806|NCT03765996|Primary|Change of the Limb Volume, (Last Value of the Follow-up − Baseline Value)|Limb size was quantified by using circumferential limb measurements. Measurements were taken with patients in a prone position and the arm abducted at 30°. The circumference was measured every 5cm, starting at the ulnar styloid and continuing 45cm proximally for both limbs. Limb volume was calculated for each segment by using the frustum formula. Frustum formula is a mathematical method for calculating limb volume based on the circumference measures, and this formula gives the result in milliliters (in: Sitzia J. Volume measurement in lymphoedema treatment: examination of formulae. Eur J Cancer Care. 1995;4:11-16). Limb measuring was carried out at the beginning of and after treatment (twenty sessions).|At baseline and at 4 weeks||||milliliter||Inter-Quartile Range|Median
2525807|NCT03765502|Secondary|Percentage of Participants Trained and Untrained Users That Find One Device Easy to Use Over the Other|Ease of use was measured via the Individual Rescue Device Ease of Use (RDEU) Questionnaire by Trained and Untrained Participants. Participants answered three questions about ease of use for each device by choosing one of five radio buttons: Strongly disagree, disagree, neither disagree nor agree, agree, strongly agree. Data here represents pooling of Simulation 1 for Part A and Part B.|Part A: Days 15 -17 and Part B: Days 8 - 9|All trained and untrained users who found both devices and completed the device preference questionnaires. PWD reporting group data not collected per protocol.|||percentage of participants|||Number
2525808|NCT03765502|Secondary|Percentage of Participants (PWD) That Prefer One Device Over the Other|Preference was measured by the PWD overall feeling of being safer during a severe low blood sugar event using Rescue Device Preference-Associated Person (RDP-AP). Participants rated their preference for NG or GEK by choosing one of five radio buttons: Strongly prefer NG, prefer NG, no preference, prefer GEK, strongly prefer GEK.|Part A: Days 15 - 17|All PWD who completed the device preference questionnaire.|||percentage of participants|||Number
2525809|NCT03765502|Secondary|Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other|Overall preference was measured via the Rescue Device Preference (RDP) questionnaire completed by Trained and Untrained participant users. Participants rated their preference for NG or GEK by choosing one of five radio buttons: Strongly prefer NG, prefer NG, no preference, prefer GEK, strongly prefer GEK. Data here represents pooling for Part A and Part B.|Part A: Days 8-9; Day 15-17 and Part B: Day 1; Days 8-9|All trained and untrained participants who found both devices and completed the rescue device preference questionnaire for Part A and Part B combined. PWD reporting group data not collected per protocol.|||percentage of participants|||Number
2526057|NCT03717064|Secondary|Period 2: Cmax of Pitavastatin Lactone||Period 2 Day 4||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2525811|NCT03765502|Secondary|Average Time for Trained Users to Successfully Administer One Device Over the Other|Average time for trained users who found both devices to successfully administer one rescue device over the other in Part A.|Part A: Day 8 and Days 15-17|All trained user participants who found both devices and completed at least one device simulation. PWD reporting group data not collected per protocol.|||seconds||Standard Deviation|Mean
2525812|NCT03765502|Secondary|Percentage of Untrained Users That Perform a Successful Administration for Each Device|Percentage of untrained users who found both devices and performed a successful administration of both rescue devices for both simulations.|Part B: Day 1 and Days 8-9|All untrained user participants who found both devices and participated in at least one simulation of a rescue device.|||percentage of participants|||Number
2525813|NCT03765502|Primary|Percentage of Trained Users That Performed a Successful Administration for Each Device|Percentage of trained users who found both devices and performed a successful administration of both rescue devices for both simulations.|Part A: Days 8 - 9 and Days 15 - 17|All trained user participants who found both devices and participated in at least one simulation of a rescue device. Participants with diabetes (PWD) reporting group data not collected per protocol.|||percentage of participants|||Number
2525814|NCT03765138|Secondary|Changes in Functional Connectivity of Fear and Reward Pathways as Measured by Functional Magentic Resonance Imaging (fMRI) Resting State Functional Connectivity (Rs-FC).|The investigators will use fMRI scans at baseline and posttreatment to assess connectivity in fear and reward circuits|baseline and week 10.|Study discontinued||||||
2525815|NCT03765138|Primary|Change in Depressive Symptoms as Measured by the Hamilton Rating Scale for Depression (HRSD).|The Hamilton Rating Scale for Depression is a 17-item instrument that was designed to measure frequency and intensity of depressive symptoms in individuals with major depressive disorder. Ratings are made using either a five- or a three-point scale, yielding total scores from 0 to 61, with higher values represent a worse outcome.|Baseline, Week 5, Week 10, 3 month follow up|Study discontinued||||||
2525816|NCT03765138|Primary|Change in PTSD Symptoms as Measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)|The CAPS is the gold standard in PTSD assessment. It is a 30-item structured interview used for current (past week or month) and lifetime diagnosis of PTSD. The CAPS was designed to be administered by clinicians and clinical researchers who have a working knowledge of PTSD. The full interview takes 45-60 minutes to administer. Scores range from 0 to 80 with higher values represent a worse outcome.|Baseline, Week 5, Week 10, 3 month follow up|Participant did not complete protocol.||||||
2525817|NCT03764813|Secondary|Median Percentage of HbF at Last Assessment|Median percentage of HbF at last HbF assessment. The last HbF measure was obtained at the completion of the 36 week of age, discharge or death.|From enrollment to the last HbF assessment|Data recorded in all patient enetering the study were included in the analysis. Patients were grouped according to the type of RBC receved.|||% HbF|median HbF (%)|Inter-Quartile Range|Median
2525818|NCT03764813|Secondary|Intervals Between Transfusions|Number of days between two consecutive transfusions.To this purpose, analysis was carried out between the two groups of RBC transfusions and patients were accordingly redistributed.|From enrollment to the last HbF assessment|Eight patients received a total number of 13 cord-RBC trasfusions and 9 patients received a total number of 18 adult -RBC transfusions. The intervals between two consecutive transfusions was recorded for each type of RBC unit.|||days|number of transfusions|Inter-Quartile Range|Median
2525819|NCT03764813|Secondary|Post-transfusion Hematocrit (Htc) Change|Change from baseline of Htc observed after either adult-RBC or cord-RBC transfusions. To this purpose, analysis was carried out between the two groups of RBC transfusions and patients were accordingly redistributed.|From enrollment to last HbF assessment|Eight patients received 13 cord-RBC units and 9 patients received 18 adult-RBC units. Change of hematocrit value after each transfusion was recorded.|||percentage of total volume|number of transfusions|Inter-Quartile Range|Median
2525820|NCT03764813|Primary|Median Percentage of HbF at 32 Weeks of Post Menstrual Age|The HbF level was determined by high-performance liquid chromatography and was expressed as percentage of total Hb, calculated as the sum of fetal and adult Hb, according to the formula: HbF= [HbF/ (FHbA1 + HbA2 + HbF)]. HbF.|From study entry to the completion of postmenstrual age of 32 weeks|The overall amount of 264 HbF results were included in the analysis. HbF was expressed as percentage of total Hb (i.e. HbF+HbA1+HbA2)|||percentage of total Hb|HbF values|Inter-Quartile Range|Median
2525821|NCT03764449|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events||Up to 35 days from screening (sceening is up to 28 days prior to admission to the clinical research unit).|The safety analysis population consisted of participants who received at least one dose of balovaptan.|||Percentage|||Number
2525822|NCT03764449|Secondary|Volume of Distribution (Vss) of IV Balovaptan||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2525823|NCT03764449|Secondary|Total Body Clearance (CL) of IV Balovaptan||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2525824|NCT03764449|Secondary|λz of M3 Metabolites||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||/hour||Geometric Coefficient of Variation|Geometric Mean
2525825|NCT03764449|Secondary|λz of M2 Metabolites||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||/hour||Geometric Coefficient of Variation|Geometric Mean
2525826|NCT03764449|Secondary|λz of Oral Balovaptan||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||/h||Geometric Coefficient of Variation|Geometric Mean
2525827|NCT03764449|Secondary|Terminal Elimination Rate Constant (λz) of IV Balovaptan||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||/hour||Geometric Coefficient of Variation|Geometric Mean
2525828|NCT03764449|Secondary|Tlast of M3 Metabolites||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Hour||Full Range|Median
2525829|NCT03764449|Secondary|Tlast of M2 Metabolites||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Hour||Full Range|Median
2525830|NCT03764449|Secondary|Tlast of Oral Balovaptan||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Hour||Full Range|Median
2525831|NCT03764449|Secondary|Time of Last Measurable Plasma Concentration (Tlast) of IV Balovaptan||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Hour||Full Range|Median
2525832|NCT03764449|Secondary|Clast of M3 Metabolites||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2525833|NCT03764449|Secondary|Clast of M2 Metabolites||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2525834|NCT03764449|Secondary|Clast of Oral Balovaptan||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2525835|NCT03764449|Secondary|Last Measurable Plasma Concentration (Clast) of IV Balovaptan||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2525836|NCT03764449|Secondary|AUC0-24 of M3 Metabolites||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2525837|NCT03764449|Secondary|AUC0-24 of M2 Metabolites||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2525838|NCT03764449|Secondary|AUC0-24 of Oral Balovaptan||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2525839|NCT03764449|Secondary|Area Under the Plasma Concentration-Time Curve Over the Dosing Interval at Steady State (AUC0-24) of IV Balovaptan||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2525840|NCT03764449|Secondary|AUC0-inf of M3 Metabolites||Day 1 of Period 1 (Period 1 is 14 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2525841|NCT03764449|Secondary|AUC0-inf of M2 Metabolites||Day 1 of Period 1 (Period 1 is 14 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2525842|NCT03764449|Secondary|AUC0-inf of Oral Balovaptan||Day 1 of Period 1 (Period 1 is 14 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2525843|NCT03764449|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of IV Balovaptan||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2525844|NCT03764449|Secondary|AUC0-last of M3 Metabolites||Day 1 of Period 1 (Period 1 is 14 days)|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2525845|NCT03764449|Secondary|AUC0-last of M2 Metabolites||Day 1 of Period 1 (Period 1 is 14 days)|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2525846|NCT03764449|Secondary|AUC0-last of Oral Balovaptan||Day 1 of Period 1 (Period 1 is 14 days)|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2525847|NCT03764449|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measurable Plasma Concentration Time Point (AUC0-last) of IV Balovaptan||Day 1 of Period 1 (Period 1 is 14 days)|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2525848|NCT03764449|Secondary|T1/2 of M3 Metabolites||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Hour||Geometric Coefficient of Variation|Geometric Mean
2525849|NCT03764449|Secondary|T1/2 of M2 Metabolites||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Hour||Geometric Coefficient of Variation|Geometric Mean
2525850|NCT03764449|Secondary|T1/2 of Oral Balovaptan||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Hour||Geometric Coefficient of Variation|Geometric Mean
2525851|NCT03764449|Secondary|Apparent Terminal Half-Life (t1/2) of IV Balovaptan||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Hour||Geometric Coefficient of Variation|Geometric Mean
2525852|NCT03764449|Secondary|Tmax of M3 Metabolites||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Hour||Full Range|Median
2525853|NCT03764449|Secondary|Tmax of M2 Metabolites||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Hour||Full Range|Median
2526058|NCT03717064|Secondary|Period 1: AUC Ratio of Pitavastatin Lactone to Pitavastatin||Period 1 Day 1||||Ratio||90% Confidence Interval|Geometric Mean
2525854|NCT03764449|Secondary|Tmax of Oral Balovaptan||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Hour||Full Range|Median
2525855|NCT03764449|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of IV Balovaptan||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all partcipants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Hour||Full Range|Median
2525856|NCT03764449|Secondary|Cmax of M3 Metabolites||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2525857|NCT03764449|Secondary|Cmax of M2 Metabolites||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2525858|NCT03764449|Secondary|Cmax of Oral Balovaptan||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2525859|NCT03764449|Secondary|Maximum Plasma Concentration (Cmax) of IV Balovaptan||Day 1 of Period 1 (Period 1 is 14 days); Day 14 of Period 2 (Period 2 is 19 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2525860|NCT03764449|Secondary|Absolute Bioavailability of Oral Balovaptan at Dose A and Dose B|Absolute oral bioavailability of balovaptan after once daily doses of Dose A and Dose B for 14 days.|Day 14 of Period 2 (Period 2 is 19 days).|PK analysis consisted of all receiving at least 1 dose balovaptan.Participants excluded from analysis, if significantly violated inclusion/exclusion criteria, deviated significantly from protocol, or if data unavailable/incomplete.There were 2 outliers;sensitivity analysis excluding those 2,resulted in similar bioavailability across all treatments.|||Percentage||Geometric Coefficient of Variation|Geometric Mean
2525861|NCT03764449|Secondary|Absolute Bioavailability of Oral Balovaptan at Dose Level B (Cohort 2)|Absolute oral bioavailability of a single dose B balovaptan.|Day 1 of Period 1 (Period 1 is 14 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Percentage||Geometric Coefficient of Variation|Geometric Mean
2525862|NCT03764449|Primary|Absolute Bioavailability of Oral Balovaptan at Dose Level A (Cohort 1)|Absolute oral bioavailability of a single dose A of balovaptan.|Day 1 of Period 1 (Period 1 is 14 days).|The Pharmacokinetic (PK) analysis population consisted of all participants who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Percentage||Geometric Coefficient of Variation|Geometric Mean
2525863|NCT03763058|Secondary|Reduction on Anxiety and Depression|This outcome will be evaluated using Hospital Anxiety and Depression Scale (HAD). The total scores range is 0-21 for both depression and anxiety scores. A higher score indicates a worse depression and anxiety. Comparison will be done between the score obtained before first music session and at the evaluation done after 3 months of music intervention.|1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)||||score on a scale||Standard Deviation|Mean
2525864|NCT03763058|Secondary|Impact of Migraines on Everyday Level of Functioning|This outcome will be evaluated using the Headache Impact Test (HIT-6) score. The total score range is 36-78. A higher score indicates a worse impact of migraines on daily life. Comparison will be done between the score obtained before first music session and at the evaluation done after 3 months of music intervention.|1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)|Difference between post and pre-treatment|||score on a scale||Standard Deviation|Mean
2525865|NCT03763058|Secondary|Number of Migraine Episodes With Severe Intensity|This data is collected as mild, moderate or severe. The same analysis as the primary outcome will be done by severity. So the frequency of migraine attacks will be compared for each severity.|1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)|Number of episodes with varying intensity (mild, moderate, severe). Only severe are reported.|||Number of episodes||Standard Deviation|Mean
2525866|NCT03763058|Secondary|Duration of Migraine Attacks (Hours)|The outcome is the mean duration of migraine attacks per month. Comparison will be done between the month prior the first music intervention and the 3rd month of intervention. The mean duration is calculated by summing the total duration during the month divided by the number of attacks in the month.|1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)||||Hours||Standard Deviation|Mean
2525896|NCT03752567|Secondary|Waiting Time|variation in waiting times for the execution of the examinations envisaged by the PDTA - Difference of waiting times for the execution of diagnostic investigations between traditional model and experimental model (difference expressed in days)|365 days||||days||Standard Deviation|Mean
2553720|NCT02770625|Secondary|Angiotensin-converting Enzyme Level||from baseline to Week 24||||U/L||Standard Deviation|Mean
2525867|NCT03763058|Primary|Frequency of Migraine Attacks (Number of Days Per Month)|All data related to migraine like frequency, duration, severity are to be collected in a diary questionnaire. Per ANAES (Agence nationale de l'accréditation et de l'évaluation en santé) recommendations, this means reduction of 50% on frequency of migraine attacks after 3-month treatment period. Comparison will be done between the number of days in the month prior the first music intervention and the number of days in the 3rd month of intervention.|1 month prior to intervention (pre-treatment) up to 3 months (post-treatment)||||Number of migraine per months||Standard Deviation|Mean
2525868|NCT03762668|Primary|High Contrast Distance Visual Acuity (logMAR)|Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.|Day 1 Dispense, Day 7 Follow-Up|All randomized subjects who were exposed to any study lenses evaluated in the study (Full Analysis Set), with non missing data.|||logMar|eyes|Standard Deviation|Mean
2525869|NCT03760510|Secondary|Number of Participants With Ett Dislodgement|frequency of ett dislodgement|duration of intubation up to 3 months|Enrolled participants receiving mechanical ventilation for at least 24 hours|||Participants|||Count of Participants
2525870|NCT03760510|Secondary|Number of Participants With Facial Skin Tear|presence of facial skin tear|48 hours post extubation up to 3 months|Enrolled participants receiving mechanical ventilation for at least 24 hours|||Participants|||Count of Participants
2525871|NCT03760510|Secondary|Number of Participants With Lip Ulcers|Presence of lip ulcer|48 hours post extubation up to 3 months|Enrolled patients mechanically ventilated for at least 24 hours|||Participants|||Count of Participants
2525872|NCT03760510|Primary|Rate of Any Incidence of the Following: Presence of Lip Ulcer, Endotracheal Tube Dislodgement, or Facial Skin Tears From the Time of Randomization to the Earlier of Death or 48 Hours After Extubation|Rate per 1000 ventilator days of any incidence of the following: presence of lip ulcer, endotracheal tube dislodgement, or facial skin tears from the time of randomization to the earlier of death or 48 hours after extubation|48 hours post extubation up to 3 months|Enrolled patients ventilated for at least 24 hours who had primary outcome data|||events per 1000 ventilator days||95% Confidence Interval|Mean
2525873|NCT03759587|Secondary|Overall Response Rate (ORR)|ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as disappearance of all target lesions; PR is defined as atleast 30% decrease in sum of diameters (SoD) of target lesions.|Up to approximately 4 months|Response-evaluable Analysis Set included participants who received at least 1 dose of study drug and had at least one measurable disease at baseline.|||percentage of participants|||Number
2525874|NCT03759587|Secondary|Overall Survival (OS)|OS is defined as the time from the study enrollment to death due to any cause.|Up to data cut-off (approximately 4 months)|Full Analysis Set included participants who received at least 1 dose of study drug.|||months||Full Range|Median
2525875|NCT03759587|Secondary|Progression Free Survival (PFS)|PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per RECIST 1.1, PD is defined as at least a 20% increase in the SoD (Sum of Diameters) of target lesions, taking as a reference the smallest (nadir) SoD since (and including) baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm.|Until disease progression, death or data cut-off (Approximately 4 months)|Full Analysis Set included participants who received at least 1 dose of study drug.|||months||Full Range|Median
2525876|NCT03759587|Secondary|Number of Participants With TEAEs Leading to Dose Reduction|An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Up to 30 days after the last dose (Approximately 4 months)|Safety Analysis Set included participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2525877|NCT03759587|Secondary|Number of Participants With TEAEs Leading to Dose Interruption|An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Up to 30 days after the last dose (Approximately 4 months)|Safety Analysis Set included participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2525878|NCT03759587|Secondary|Number of Participants With TEAEs Leading to Drug Discontinuation|An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Up to 30 days after the last dose (Approximately 4 months)|Safety Analysis Set included participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2525879|NCT03759587|Secondary|Number of Participants With Serious Adverse Events (SAEs)|An SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.|Up to 30 days after the last dose (Approximately 4 months)|Safety Analysis Set included participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2525892|NCT03752567|Secondary|Economic Impact|"Evaluation of the economic impact secondary to the establishment of the figure of the community pharmacist as Case Manager and to the use of the pharmacy of service (Comparison costs/benefits in euro between traditional assistence model and this innovative assistance model) ( comparison between the costs currently incurred by the Italian health care system for the assistance to patients with type 2 diabetes and the related benefits and costs deriving from the adoption of a care model such as the one object of research and the relative benefits)"|12 months||||euro/patient/year||Standard Deviation|Mean
2525880|NCT03759587|Secondary|Number of Participants With Grade 3 or Higher TEAEs|An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A severity grade is defined by the NCI-CTCAE Version 4.03. As per NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.|Up to 30 days after the last dose (Approximately 4 months)|Safety Analysis Set included participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2525881|NCT03759587|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to 30 days after the last dose (Approximately 4 months)|Safety Analysis Set included participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2525882|NCT03759587|Primary|Number of Participants With Grade 3 or 4 Thrombocytopenia Occurring Within 30 Days After Initial Administration of Niraparib|An adverse event of 'thrombocytopenia' was collected and graded as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03.As per the NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to Adverse Events (AE).|Up to 30 days after the first dose|Safety Analysis Set included participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2525883|NCT03758365|Primary|Compare Local Tolerability of the MC2-01 Cream With Active Comparators and Vehicle|The local tolerability of the creams will be assesed using a predefined scale: 0 = No reaction; 0.5 = Only slight erythema; 1 = Only erythema; 2 = Erythema with papules or oedema; 3 = Erythema, oedema with papules, oedema with vesicle; 4 = Blisters|Day 2|The local tolerance score is presented as number of participants with observed local reaction by trial product and severity.|||Participants|||Count of Participants
2525884|NCT03758365|Primary|Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle|Blanching of the skin will be assessed individually by two trained observers blinded to treatment. The observers will score the blanching of the skin from 0-4 (0 = No change in color skin; 1 = Slight (barely visible) blanching; 3 = Obvious blanching; 4 = Blanching judged to be maximal). The results is presented as Mean ± SD.|Day 2|As the study design is a within subject evaluation of the vasoconstriction properties of MC2-01 cream compared with vehicle cream and 5 other corticosteroids, all 36 enrolled subjects received a single treatment with all 7 products.|||score on a scale||Standard Deviation|Mean
2525885|NCT03757039|Primary|Average Transition Time, Calculated From a Maximum of 3 Readings, Recorded in Seconds, During Alternate Viewing From Distance (4 m) to Intermediate (80 cm) and Vice Versa (Full Analysis Set)|The subject was asked to read text at distance (4 meters) or intermediate (80 centimeters), followed immediately by text at the alternate viewing (intermediate or distance). The interval between when the subject stopped reading the first text and started reading the second text is defined as the transition time. Due to inconsistent measurement of the primary endpoint in this study, interpretation of the average transition times was compromised and the planned inferential analysis was not carried out.|Day 1, after up to 3 hours of wear|This analysis population includes all subjects assigned to PALs or randomized to the contact lens group who were exposed to any study product evaluated in this study, except for the lenses used for optimization and fitting (Full Analysis Set).|||seconds||Standard Deviation|Mean
2525886|NCT03756038|Secondary|Negative Affect in the Emergency Department|Positive and Negative Affect Schedule (PANAS)-We will use the 10 items of the Negative Affect Scale; each of these items are scored on a Likert Scale ranging from 1 (very slightly/not at all) to 5 (extremely). The responses for each of the 10 items are summed to create the Negative Affect Score; scores may range from 10-50, with lower scores representing lower scores of negative affect.|"The 10 items of the Negative Affect Scale are anchored to mood right now at 60 minutes post-study drug administration."|No subjects were enrolled in the placebo group because enrollment was prematurely halted due to lack of feasibility|||units on a scale|||Number
2525887|NCT03756038|Primary|Pain Severity in the Emergency Department: Numeric Rating Scale|Pain Numeric Rating Scale (on a scale from 0, no pain to 10, worst pain imaginable)|"The item is anchored to pain intensity right now at 60 minutes post-study drug administration"|No one was enrolled in the placebo group because we prematurely halted enrollment due to lack of feasibility|||units on a scale|||Number
2525888|NCT03755882|Primary|Visual Performance|Monocular visual performance (logMAR) was evaluated under 3 conditions (1.high luminance and high contrast, 2. High Lumiance Low Contrast and 3. Low Luminance High Contrast with distance goggles) at 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letter-by-letter results were calculated to ascertain the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.|Up to 2-Week Follow-up|All subjects who had successfully completed all visits.|||logMAR Units|Eyes|Standard Deviation|Mean
2525889|NCT03753113|Secondary|Adverse Events|Incidence of adverse events such as itching, redness, inflammation etc|baseline, 12, 24, and 36 weeks||||Participants|||Count of Participants
2525890|NCT03753113|Secondary|Patients Self - Assessment Questionnaire|Self-administered hair growth questionnaire, consisting of 4 questions in the patient's language on treatment efficacy and three questions on satisfaction with appearance. For differences between self-assessment questionnaires. This questionnaire following 5-point scale: 1 = very satisfied, 2 = satisfied, 3 = neutral (neither satisfied nor dissatisfied), 4 = dissatisfied, 5 = very dissatisfied. Higher scores indicated a worse outcome.|through study completion|All participants for whom data were collected at weeks 36.|||score on a scale||Standard Deviation|Mean
2525891|NCT03753113|Primary|Change in Hair Diameter|Change in hair diameter over time as compared to Baseline. Hair diameter measured via a digital micrometer.|baseline, 12, 24, and 36 weeks||||micrometer||Standard Deviation|Mean
2526059|NCT03717064|Secondary|Period 1: AUC0-inf of Pitavastatin Lactone||Period 1 Day 1||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2525897|NCT03752567|Primary|Percent of Participants With Adherence to the PDTA|"Measure of the variation - compared to a historical cohort - of the percentage of adherence to PDTA (patients who performed the scheduled checks at 3-6-12 months / total of patients enrolled x 100) in the cohort of the patients enrolled in the study and therefore followed from a case manager identified in the community pharmacist with the opportunity to perform the checks provided in telemedicine and in self-analysis, thanks to the exploitation of pharmacy of service."|12 months||||percentage of participants|||Number
2525898|NCT03748758|Secondary|Evaluation of Systemic Exposure of CP: Baseline-corrected CP Serum Concentrations (µM) by Nominal Timepoint|This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day|Day 1 and Day 14|"It is pre-specified to collect and report data for only Cohort B and Placebo Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times."|||µM||Standard Deviation|Mean
2525899|NCT03748758|Secondary|Evaluation of Systemic Exposure of DPPC: Baseline-corrected DPPC Serum Concentration (µg/mL) by Nominal Timepoint|This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day|Day 1 and Day 14|"It is pre-specified to collect and report data for only Cohort B and Placebo Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times."|||µg/mL||Standard Deviation|Mean
2525900|NCT03748758|Secondary|Evaluation of Systemic Exposure of CP: Observed CP Serum Concentrations (µM) by Nominal Timepoint|This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day|Day 1 and Day 14|"It is pre-specified to collect and report data for only Cohort B and Placebo Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times."|||µM||Standard Deviation|Mean
2525901|NCT03748758|Secondary|Evaluation of Systemic Exposure of DPPC: Observed DPPC Serum Concentration (µg/mL) by Nominal Timepoint|This will be evaluated by collecting blood on Day 1 baseline, Day 14 at 30 minutes pre-dose, and 5, 20, 35, and 50 minutes post-dose only in OP0201 Cohort B 60 mg per day|Day 1 and Day 14|"It is pre-specified to collect and report data for only Cohort B and Placebo Arms/Groups per protocol. The Number of participants analyzed for Cohort B at Day 14, 30 mins pre-dose and 5 mins post-dose is one less compared to other timepoints due to exclusion of serum samples that had missing collection times."|||µg/mL||Standard Deviation|Mean
2525902|NCT03748758|Primary|Number of Participants With of Adverse Events||21 Days||||Participants|||Count of Participants
2525903|NCT03745092|Secondary|The Fronto-central Wavelet Entropy Change|The entropy is computed via nonlinear dynamics method and represents the complexity of the signal in the information science initially (with units nat). It can also be applied in assessing the complexity of the EEG signal to evaluate the brain functions. The wavelet entropy analysis is a sub-type of entropy which is proceeded with wavelet transform. The wavelet entropy analysis provides a quantitative measure of the degree of disorder in the brain rhythm at various times in brain injury and recovery. The higher value of the wavelet entropy indicates the better brain functions. The fronto-central wavelet entropy change in this study is defined as the wavelet entropy value at the baseline EEG minus the post-intervention EEG over the fronto-central electrodes (F3, F4, Fz, C3, C4, Cz).|30 minutes baseline EEG, 45 minutes intervention, 30 minutes post-intervention EEG||||nat||Standard Deviation|Mean
2525904|NCT03745092|Secondary|The Post-intervention Fronto-central Delta/Alpha Ratio|The patients undergo 30-minute EEG recordings two times. Between the two times of EEG recordings, the patients are performed with the specific interventions (NBO or rest) for 45 minutes. The post-intervention fronto-central delta/alpha ratio is computed as the delta absolute power/the alpha absolute power over the fronto-central electrodes (C3, C4, Cz, F3, F4, Fz) at the post-intervention EEG. The alpha and delta (1-4Hz) absolute power (with units microvolts squared) is computed using Fast Fourier Transform for each electrode over the alpha (8-12Hz) and delta (1-4Hz) frequency band.|30 minutes baseline EEG, 45 minutes intervention, 30 minutes post-intervention EEG||||ratio||Inter-Quartile Range|Median
2525905|NCT03745092|Secondary|The Post-intervention Fronto-central (Delta+Theta)/(Alpha+Beta) Ratio|The patients undergo 30-minute EEG recordings two times. Between the two times of EEG recordings, the patients are performed with the specific interventions (NBO or rest) for 45 minutes. The post-intervention fronto-central (delta+theta)/(alpha+beta) ratio is computed as (the delta+theta absolute power)/(the alpha+beta absolute power) over the fronto-central electrodes (C3, C4, Cz, F3, F4, Fz) at the post-intervention EEG. The beta, alpha, theta and delta absolute power (with units microvolts squared) is computed using Fast Fourier Transform for each electrode over the beta (12-20Hz), alpha (8-12Hz), theta (4-8Hz) and delta (1-4Hz) frequency band.|30 minutes baseline EEG, 45 minutes intervention, 30 minutes post-intervention EEG||||ratio||Inter-Quartile Range|Median
2525906|NCT03745092|Secondary|The Post-intervention Fronto-central Theta/Alpha Ratio|The patients undergo 30-minute EEG recordings two times. Between the two times of EEG recordings, the patients are performed with the specific interventions (NBO or rest) for 45 minutes. The post-intervention fronto-central theta/alpha ratio is computed as the theta absolute power/the alpha absolute power over the fronto-central electrodes (C3, C4, Cz, F3, F4, Fz) at the post-intervention EEG. The alpha and theta absolute power (with units microvolts squared) is computed using Fast Fourier Transform for each electrode over the alpha (8-12Hz) and theta (4-8Hz) frequency band.|30 minutes baseline EEG, 45 minutes intervention, 30 minutes post-intervention EEG||||ratio||Inter-Quartile Range|Median
2525907|NCT03745092|Primary|The Fronto-central Delta Absolute Power Reduction Rate|The patients undergo 30-minute EEG recordings two times. Between the two times of EEG recordings, the patients are performed with the specific interventions (NBO or rest) for 45 minutes. The fronto-central delta absolute power change rate was calculated as the delta (1-4Hz) absolute power at (the baseline EEG minus the post-intervention EEG)/the baseline EEG over the fronto-central electrodes (F3, F4, Fz, C3, C4, Cz). The delta absolute power (with units microvolts squared) is computed using Fast Fourier Transform for each electrode over the delta frequency band.|30 minutes baseline EEG, 45 minutes intervention, 30 minutes post-intervention EEG||||ratio||Inter-Quartile Range|Median
2525908|NCT03745092|Primary|The Fronto-central Theta Absolute Power Change Rate|The patients undergo 30-minute EEG recordings two times. Between the two times of EEG recordings, the patients are performed with the specific interventions (NBO or rest) for 45 minutes. The fronto-central theta absolute power change rate was calculated as the theta (4-8Hz) absolute power at (the baseline EEG minus the post-intervention EEG)/the baseline EEG over the fronto-central electrodes (F3, F4, Fz, C3, C4, Cz). The theta absolute power (with units microvolts squared) is computed using Fast Fourier Transform for each electrode over the theta frequency band.|30 minutes baseline EEG, 45 minutes intervention, 30 minutes post-intervention EEG||||ratio||Inter-Quartile Range|Median
2525909|NCT03744780|Secondary|Feasibility Data: Recruitment, Eligibility, Attendance, and Attrition Rates|These include recruitment, eligibility, attendance, and attrition rates|Assessed throughout the duration of the study from the recruitment period to the completion of the workshops and follow-up questionnaires (i.e., over a 3-month period).|The population of analysis were the 59 individuals who initially expressed interest in the study.|||Participants|||Count of Participants
2525910|NCT03744780|Secondary|Ability to Stop Emotional Eating - 3-months Post-intervention|As assessed by a single self-report item developed by the study's authors. Participants were asked to report the number of instances in which they began to engage in emotional eating and were able to stop themselves, on a scale from 1 (none of the time) to 5 (very often).|Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention|Based on incomplete questionnaire data, 28/32 participants were included in the final analyses.|||units on a scale||Standard Deviation|Mean
2525911|NCT03744780|Secondary|Ability to Stop Emotional Eating - 2-weeks Post-intervention|As assessed by a single self-report item developed by the study's authors. Participants were asked to report the number of instances in which they began to engage in emotional eating and were able to stop themselves, on a scale from 1 (none of the time) to 5 (very often).|Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention|Based on incomplete questionnaire data, 28/32 participants were included in the final analyses.|||units on a scale||Standard Deviation|Mean
2525912|NCT03744780|Secondary|Emotional Eating Frequency - 3-months Post-intervention|As assessed by a self-report item developed by the study's authors. Participants were asked to report the number of times they engaged in emotional eating in the past week.|Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention|Based on incomplete questionnaire data, 28/32 participants were included in the final analyses.|||times per week||Standard Deviation|Mean
2525913|NCT03744780|Secondary|Emotional Eating Frequency - 2-weeks Post-intervention|As assessed by a self-report item developed by the study's authors. Participants were asked to report the number of times they engaged in emotional eating in the past week.|Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention|Based on incomplete questionnaire data, 28/32 participants were included in the final analyses.|||times per week||Standard Deviation|Mean
2525914|NCT03744780|Secondary|ACT Values Application - 3-months Post-intervention|Application of ACT values techniques taught during the workshop, as assessed by items developed by the study's authors. Participants were asked to rate the extent to which they agreed with a number of value-based statements on a scale from 1 (strongly disagree) to 5 (strongly agree). Values score was derived by taking the mean of the items, with higher scores reflecting greater value-consistent eating behaviors.|Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention|Based on incomplete questionnaire data, 28/32 participants were included in the final analyses.|||units on a scale||Standard Deviation|Mean
2525915|NCT03744780|Secondary|ACT Values Application - 2-weeks Post-intervention|Application of ACT values techniques taught during the workshop, as assessed by items developed by the study's authors. Participants were asked to rate the extent to which they agreed with a number of value-based statements on a scale from 1 (strongly disagree) to 5 (strongly agree). Values score was derived by taking the mean of the items, with higher scores reflecting greater value-consistent eating behaviors.|Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention|Based on incomplete questionnaire data, 28/32 participants were included in the final analyses.|||units on a scale||Standard Deviation|Mean
2525916|NCT03744780|Secondary|Mindful Eating - 3-months Post-intervention|"Mindful eating, as assessed by the Mindful Eating Questionnaire (MEQ). It is a 28-item self-report measure that assesses five domains of mindful eating: disinhibition, external cues, awareness, emotional response and distraction. Participants are asked to indicate the extent to which extent they agree with each item from 1 (never / rarely) to 4 (usually/ always), with higher scores reflecting higher levels of mindful eating. Total score is derived by taking the mean of the five subscales."|Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention|Based on incomplete questionnaire data, 28/32 participants were included in the final analyses.|||units on a scale||Standard Deviation|Mean
2525917|NCT03744780|Secondary|Mindful Eating - 2-weeks Post-intervention|"Mindful eating, as assessed by the Mindful Eating Questionnaire (MEQ). It is a 28-item self-report measure that assesses five domains of mindful eating: disinhibition, external cues, awareness, emotional response and distraction. Participants are asked to indicate the extent to which extent they agree with each item from 1 (never / rarely) to 4 (usually/ always), with higher scores reflecting higher levels of mindful eating. Total score is derived by taking the mean of the five subscales."|Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention|Based on incomplete questionnaire data, 28/32 participants were included in the final analyses.|||units on a scale||Standard Deviation|Mean
2525918|NCT03744780|Secondary|Food Craving Acceptance and Action - 3-months Post-intervention|Food craving acceptance and action, as assessed by the Food Craving Acceptance and Action Questionnaire (FAAQ). Items are rated on a 6-point Likert-type rating scale from 1 (very seldom true) to 6 (always true), with higher scores reflecting higher acceptance. Total score is derived by summing all items. Minimum score is 10 and maximum score is 60.|Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention|Based on incomplete questionnaire data, 28/32 participants were included in the final analyses.|||units on a scale||Standard Deviation|Mean
2525935|NCT03739242|Secondary|Change in Serum Creatinine|Mean change in Serum Creatinine values from randomization (day 0) to V4 (week 8)|From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment|Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).|||mg/dL||Standard Deviation|Mean
2525919|NCT03744780|Secondary|Food Craving Acceptance and Action - 2-weeks Post-intervention|Food craving acceptance and action, as assessed by the Food Craving Acceptance and Action Questionnaire (FAAQ). Items are rated on a 6-point Likert-type rating scale from 1 (very seldom true) to 6 (always true), with higher scores reflecting higher acceptance. Total score is derived by summing all items. Minimum score is 10 and maximum score is 60.|Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention|Based on incomplete questionnaire data, 28/32 participants were included in the final analyses.|||units on a scale||Standard Deviation|Mean
2525920|NCT03744780|Secondary|Distress Tolerance - 3-months Post-Intervention|Distress tolerance, as assessed by the Distress Tolerance Scale (DTS). Participants are asked to indicate the extent to which they agree with statements aimed at assessing distress tolerance, absorption, appraisal, and regulation from 1 (strongly agree) to 5 (strongly disagree), with lower scores reflecting lower distress tolerance. Subscale scores are derived by calculating the means of the items that make up each subscale. Total score is calculating by averaging the four subscales.|Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention|Based on incomplete questionnaire data, 28/32 participants were included in the final analyses.|||units on a scale||Standard Deviation|Mean
2525921|NCT03744780|Secondary|Distress Tolerance - 2-weeks Post-Intervention|Distress tolerance, as assessed by the Distress Tolerance Scale (DTS). Participants are asked to indicate the extent to which they agree with statements aimed at assessing distress tolerance, absorption, appraisal, and regulation from 1 (strongly agree) to 5 (strongly disagree), with lower scores reflecting lower distress tolerance. Subscale scores are derived by calculating the means of the items that make up each subscale. Total score is calculating by averaging the four subscales.|Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention|Based on incomplete questionnaire data, 28/32 participants were included in the final analyses.|||units on a scale||Standard Deviation|Mean
2525922|NCT03744780|Primary|Emotional Eating - 3-months Post-Intervention|Emotional eating, as assessed by the Dutch Eating Behaviour Questionnaire Emotional Eating Subscale (DEBQ-EE). Participants are asked to rate the frequency with which they engage in particular eating behaviours, on a 5-point Likert-type rating scale from never (1) to very often (5), with higher scores reflecting higher emotional eating. Only the emotional eating subscale of the DEBQ will be assessed and is calculated by averaging the 13 items that assess emotional eating.|Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention|Based on incomplete questionnaire data, 28/32 participants were included in the final analyses.|||units on a scale||Standard Deviation|Mean
2525923|NCT03744780|Primary|Emotional Eating - 2-weeks Post-intervention|Emotional eating, as assessed by the Dutch Eating Behaviour Questionnaire Emotional Eating Subscale (DEBQ-EE). Participants are asked to rate the frequency with which they engage in particular eating behaviours, on a 5-point Likert-type rating scale from never (1) to very often (5), with higher scores reflecting higher emotional eating. Only the emotional eating subscale of the DEBQ will be assessed and is calculated by averaging the 13 items that assess emotional eating.|Assessed from baseline to 2-weeks post-intervention and 3-months post-intervention|Based on incomplete questionnaire data, 28/32 participants were included in the final analyses.|||units on a scale||Standard Deviation|Mean
2525924|NCT03742271|Primary|Acceptable Lens Fitting|Acceptable fit is determined by the eye care practitioner (ECP/investigator) and includes the following criteria; (1) physiological responses (No Grade 3 or higher slit lamp findings), (2) mechanical lens fitting (no unacceptable lens fitting in either eye), (3) subjects' assessment of comfort, vision and handling.|4-Week Follow-up|All subjects who were administered a Test lens and completed through the 4-week evaluation in which the eye care practitioner completed the lens fitting assessment.|||Proportion of subjects|||Number
2525925|NCT03741725|Secondary|Social Cohesion|Frequency of men, defined as number of men who report feelings of being able to depend on a larger MSM community (i.e., tongzhi circle, gay online networks or groups)|enrollment period|||||||
2525926|NCT03741725|Secondary|Community Connectedness|Frequency of men, defined as number of men who report feelings of belonging to a larger MSM community (i.e., tongzhi circle, gay online networks or groups)|enrollment period|||||||
2525927|NCT03741725|Secondary|Community Engagement|Frequency of men, defined as number of men who report awareness of and/or participation in MSM-related causes, organizations, or community events|enrollment period|||||||
2525928|NCT03741725|Secondary|Incremental Cost Per Diagnosis|Incremental cost, defined as the cost associated with respective interventions (development, start-up, implementation, intervention) per individual who tested positive for gonorrhea and/or chlamydia following the intervention|enrollment period|||||||
2525929|NCT03741725|Secondary|Incremental Cost Per Test|Incremental cost, defined as the cost associated with respective interventions (development, start-up, implementation, intervention) per individual who reported testing for gonorrhea and chlamydia following the intervention|enrollment period|||||||
2525930|NCT03741725|Secondary|Chlamydia Testing by Administrative Record|Frequency of men, defined as the number of men who tested for chlamydia (urine and/or anal swab) outside of the intervention, as confirmed by administrative record|enrollment period|||||||
2525931|NCT03741725|Secondary|Gonorrhea Testing by Administrative Record|Frequency of men, defined as the number of men who tested for gonorrhea (urine and/or anal swab) outside of the intervention, as confirmed by administrative record|enrollment period|||||||
2525932|NCT03741725|Primary|Dual Gonorrhea/Chlamydia Test Uptake|Dual gonorrhea/chlamydia test uptake as assessed by administrative records, divided by the number men in the respective arm|study enrollment period||||Participants|||Count of Participants
2525933|NCT03739242|Secondary|Change in Creatine Phosphokinase (CPK)|Mean change in creatine phosphokinase (CPK) from randomization (day 0) to V4 (week 8)|From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment|Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).|||U/L||Standard Deviation|Mean
2525934|NCT03739242|Secondary|Change in Serum Uric Acid|Mean change in Serum uric acid values from randomization (day 0) to V4 (week 8)|From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment|Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).|||mg/dL||Standard Deviation|Mean
2553721|NCT02770625|Secondary|Liver Volume||from baseline to Week 24||||Milliliters||Standard Deviation|Mean
2525936|NCT03739242|Secondary|Change in Gamma Glutamyl Transpeptidase (GGT)|Mean change gamma glutamyl transpeptidase (GGT) from randomization (day 0) to V4 (week 8)|From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment|Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).|||U/L||Standard Deviation|Mean
2525937|NCT03739242|Secondary|Change in Alanine Aminotransferase (ALT)|Mean change in aspartate aminotransferase from randomization (day 0) to V4 (week 8)|From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment|Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).|||U/L||Standard Deviation|Mean
2525938|NCT03739242|Secondary|Change in Aspartate Aminotransferase (AST)|Mean change in aspartate aminotransferase from randomization (day 0) to V4 (week 8)|From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment|Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).|||U/L||Standard Deviation|Mean
2525939|NCT03739242|Secondary|Change in Glycemia|Mean change in Glycemia from randomization (day 0) to V4 (week 8)|From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment|Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).|||mg/dL||Standard Deviation|Mean
2525940|NCT03739242|Secondary|Change in Pulse Volume (PV) Waveform (Endothelial Reactivity)|"Mean change in Pulse Volume (PV) waveform from randomization (day 0) to V4 (week 8).~PV unit of measurement is a percent change in the PV waveform area, comparing waveforms during and before hyperemia through the equation √PV2/PV1 that relates PV at baseline (PV1) and PV during hyperemia (PV2)."|From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment|Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).|||percentage of change||Standard Deviation|Mean
2525941|NCT03739242|Secondary|Change in Total LDL Cholesterol/HDL Cholesterol Ratio|Mean change in LDL/HDL cholesterol ratio from randomization (day 0) to V4 (week 8)|From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment|Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).|||ratio||Standard Deviation|Mean
2525942|NCT03739242|Secondary|Change in Total Cholesterol/HDL Cholesterol Ratio|Mean change in total cholesterol/HDL cholesterol ratio from randomization (day 0) to V4 (week 8)|From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment|Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).|||ratio||Standard Deviation|Mean
2525943|NCT03739242|Secondary|Change in Blood Apolipoprotein B Level|Mean change in blood apolipoprotein B level from randomization (day 0) to V4 (week 8)|From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment|Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).|||mg/dL||Standard Deviation|Mean
2525944|NCT03739242|Secondary|Change in Blood Triglycerides Level|Mean change in blood triglycerides level from randomization (day 0) to V4 (week 8)|From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment|Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).|||mg/dL||Standard Deviation|Mean
2525945|NCT03739242|Secondary|Change in Blood Non-HDL Cholesterol Level|Mean change in blood non-HDL cholesterol level from randomization (day 0) to V4 (week 8)|From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment|Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).|||mg/dL||Standard Deviation|Mean
2525946|NCT03739242|Secondary|Change in Blood HDL Cholesterol Level|Mean change in blood HDL cholesterol level from randomization (day 0) to V4 (week 8)|From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment|Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).|||mg/dL||Standard Deviation|Mean
2525947|NCT03739242|Secondary|Change in Total Blood Cholesterol Level|Mean change in total blood LDL cholesterol level from randomization (day 0) to V4 (week 8)|From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment|Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).|||mg/dL||Standard Deviation|Mean
2525948|NCT03739242|Primary|Change in Blood LDL Cholesterol Level|Mean change in blood LDL cholesterol level from randomization (day 0) to V4 (week 8)|From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment|Population analysed is the Full Analysis Set one (FAS), composed by all randomization subjects who completed all the visits and were assessed for LDL cholesterol at last visit (Visit 4 - Week 8).|||mg/dL||Standard Deviation|Mean
2525949|NCT03738020|Primary|Average of Wrinkle Severity Rating Scale (WSRS) Score Evaluated by the Evaluating Investigator at Week 26 (Visit 7) After the Final Treatment With the Investigational Medical Device|"Wrinkle Severity Rating Scale (WSRS)~Absent: no visible fold; continuous line~Mild: Shallow but visible fold with slight indentation; minor facial feature~Moderate: moderately deep fold; clear facial feature visible at normal appearance but not when stretched. Excellent correction expected.~Severe: very long and deep; prominent facial feature; less than 2mm visible fold when stretched~Extreme: extremely deep and long folds; 2-4mm visible v-shaped fold when stretched; detrimental to appearance; unlikely to have satisfactory correction with injectable implant alone"|Week 26 (Visit 7)|Spilt-face design|||score on a scale||Standard Deviation|Mean
2525972|NCT03727854|Secondary|Change in Fasting Blood Glucose Level From Baseline||0 week, 12 weeks||||mg/dL||Standard Deviation|Mean
2525973|NCT03727854|Primary|Change in HbA1c From Baseline||0 week, 12 weeks||||% (HbA1c)||Standard Deviation|Mean
2525950|NCT03735862|Other Pre-specified|Likelihood to Recommend|Patients were asked to report how likely they would be to recommend this procedure to a friend or loved one with the same condition. Report was based on a scale of 1 (not at all likely) to 10 (very likely).|6-18 Months post index procedure|12 patients declined participation or could not be contacted.|||Participants|||Count of Participants
2525951|NCT03735862|Other Pre-specified|Satisfaction With Procedure|"Patients reported their satisfaction with the procedure as Dissatisfied, Neutral, or Satisfied."|6-18 Months post index procedure|12 patients declined participation or could not be contacted.|||Participants|||Count of Participants
2525952|NCT03735862|Secondary|Medication Use|Use of PPIs in 3-months prior to follow-up interview|6-18 months post index procedure|12 patients declined participation or could not be contacted. One patient did not answer.|||Participants|||Count of Participants
2525953|NCT03735862|Secondary|Gastroesophageal Reflux Disease Health Related Quality of Life Score (GERD-HRQL)|The GERD-HRQL score assess the severity of GERD symptomatic and impact on the subjects quality of life. The score is comprised of 10 questions whose answers are summed for the final score. THe score can range from 0 to 50, with 50 being the worst and 0 meaning no impact.|6-18 months post index procedure|12 patients declined participation or could not be contacted.|||Score||Standard Deviation|Mean
2525954|NCT03735862|Primary|Number of Subjects Who Required a Revision of the Index Surgery.|Patient self-report if they had a revision or other laparoscopic surgery following index procedure.|6-18 months post index procedure|12 patients declined participation or could not be contacted.|||Participants|||Count of Participants
2525955|NCT03734822|Primary|Accuracy of CO2 Levels|Looking at the accuracy of CO2 levels assessed via end tidal CO2 (ETCO2), capillary CO2 (Cap-CO2), and transcutaneous CO2 (TCCO2) compared to arterial blood gas (ABG) which is the gold standard.|Immediately following induction of anesthesia||||mmHg||Standard Deviation|Mean
2525956|NCT03733899|Secondary|Subjective Comfort Difference Between Post-removal and Preinsertion Within Anesthetic and Cornea|Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.|Immediately before lens-insertion (pre-insertion), 30 seconds after lens removal|All randomized subjects regardless of actual treatment and subsequent withdrawl from study or deviation from protocol.|||Units on a Scale|Eyes|Standard Deviation|Mean
2525957|NCT03733899|Secondary|Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions|Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.|14 hours upon lens-insertion (pre-treatment), 5- and 10- minutes post-treatment|All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.|||Units on a Scale|eyes|Standard Deviation|Mean
2525958|NCT03733899|Secondary|Change in Subjective Comfort Between Ocular Regions at Posttreatment Within Anesthetic|Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.|5 and 10 minutes post treatment|All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.|||Units on a Scale|eyes|Standard Deviation|Mean
2525959|NCT03733899|Primary|Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic|Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.|Immediately after lens-insertion, 5 and 10 minutes post-treatment|All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.|||Units on a Scale|eyes|Standard Deviation|Mean
2525960|NCT03733899|Primary|Change in Subjective Comfort Scores From Pre-treatment to Post-treatment|Subjects were asked to rate how comfortable each eye was overall using a visual analog scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable. Subjects wore their habitual contacts during the pre-treatment assessment.|14-Hours upon Lens-Insertion (pre-treatment), and 10 Minutes post-treament|All randomized subjects regardless of actual treatment and subsequent withdrawl from the study or deviation from protocol.|||Units on a Scale|eyes|Standard Deviation|Mean
2525961|NCT03733899|Primary|Subjective Comfort Scores|Subjects were asked to rate how comfortable each eye was overall using a visual analog scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.|5 and 10 Minutes post-treament|All randomized subjects regardless of actual treatment and subsequent withdrawl from the study or deviation from protocol.|||Units on a Scale|eyes|Standard Deviation|Mean
2525962|NCT03733470|Primary|Perfused Blood Volume Assessed for a Change in Lung Inflammation Pre and Post Dose Sildenafil Administration|Perfused blood volume will be measured by CT scan at two time points and compared at two points, pre and post the administration of sildenafil.|Change of perfused blood volume from baseline at one hour after sildenafil administration.||||coefficient of variation||Standard Deviation|Mean
2525963|NCT03728140|Primary|Live Birth|Observe the live birth rate under different embryo transfer methods|40 weeks||||Participants|||Count of Participants
2525964|NCT03728140|Primary|Number of Participants Pregnant After 4 Weeks|Observe the clinical pregnancy rate under different embryo transfer methods|4 weeks||||Participants|||Count of Participants
2525965|NCT03727854|Secondary|Change in Homeostatic Model Assessment of β-cell Function (HOMA-beta) From Baseline|Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is an index to estimate the insulin resistance of a subject. HOMA-IR is defined as ( glucose (mg/dl) X insulin (uIU/ml) ) / 405.|0 week, 12 weeks||||units||Standard Deviation|Mean
2525966|NCT03727854|Secondary|Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) From Baseline|Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is an index to estimate the insulin resistance of a subject. HOMA-IR is defined as ( glucose (mg/dl) X insulin (uIU/ml) ) / 405.|0 week, 12 weeks||||units||Standard Deviation|Mean
2525967|NCT03727854|Secondary|Change in Blood Low-density Lipoprotein Level From Baseline||0 week, 12 weeks||||mg/dL||Standard Deviation|Mean
2525968|NCT03727854|Secondary|Change in Blood High-density Lipoprotein Level From Baseline||0 week, 12 weeks||||mg/dL||Standard Deviation|Mean
2525969|NCT03727854|Secondary|Change in Blood Triglyceride Level From Baseline||0 week, 12 weeks||||mg/dL||Standard Deviation|Mean
2525970|NCT03727854|Secondary|Change in Waist Circumference From Baseline||0 week, 12 weeks||||cm||Standard Deviation|Mean
2525971|NCT03727854|Secondary|Change in Body Weight From Baseline||0 week, 12 weeks||||kg||Standard Deviation|Mean
2525974|NCT03727373|Secondary|Number of Participants Willing to Assess Their Pain Using Technology for Their Own Interest Only|Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain using technology, if this was for their own interest only.|1 day (during the interview)||||Participants|||Count of Participants
2525975|NCT03727373|Secondary|Number of Participants Willing to Assess Their Pain Using Technology, if Required by Treating Physician|Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain using technology, if required by their treating physician.|1 day (during the interview)||||Participants|||Count of Participants
2525976|NCT03727373|Secondary|Number of Participants Willing to Assess Their Pain Themselves|Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain themselves.|1 day (during the interview)||||Participants|||Count of Participants
2525977|NCT03727373|Secondary|Number of Participants Already Using Technology for Assessment of Pain or Other Medical Symptoms/Outcomes (e.g. Blood Pressure)|Patients were asked during a semi-structured qualitative interview, if they were already using technology for assessment of pain or other medical symptoms/outcomes (e.g. blood pressure).|1 day (during the interview)||||Participants|||Count of Participants
2525978|NCT03727373|Secondary|Number of Participants Considering Regular Assessment of Pain Important|Patients were asked during a semi-structured qualitative interview, if they were considering regular assessment of their pain important.|1 day (during the interview)||||Participants|||Count of Participants
2525979|NCT03727373|Secondary|Number of Participants Satisfied With Assessment of Pain Performed by Medical Staff Members|Patients were asked during a semi-structured qualitative interview, if they were satisfied with the assessment of their pain when performed by medical staff members.|1 day (during the interview)||||Participants|||Count of Participants
2525980|NCT03727373|Secondary|Number of Participants Impaired by Pain During Daily Life|Patients were asked during a semi-structured qualitative interview, if they were impaired by pain during their daily life.|1 day (during the interview)||||Participants|||Count of Participants
2525981|NCT03727373|Primary|Number of Participants Willing to Assess Their Pain Using Technology|Patients were asked during a semi-structured qualitative interview, if they were willing to assess their pain using technology.|1 day (during the interview)||||Participants|||Count of Participants
2525982|NCT03725982|Secondary|History of Musculoskeletal Disorders and Symptoms|Using the Standard Nordic Questionnaire, the history of musculoskeletal disorders and symptoms is evaluated.|Directly before the experiment (baseline, 0 min)||2020-04-30|04/2020||||
2525983|NCT03725982|Secondary|Evaluation of Workload|"The NASA Task Load Index (TLX) of Hart and Staveland (1988) will be used to evaluate workload. This standardized tool contains six dimensions (mental demand, physical demand, temporal demand, own performance, effort, frustration), of which each scale ranges from from 0 (low) to 100 (high).~We will include three dimensions of interest, i.e. physical demand, temporal demand, effort, and calculate the unweighted average of the score of these three dimensions (Hoonakker et al. 2011)."|Directly after the experimental condition during which the exoskeleton was worn (~ 4.5-6.5 min)||2020-04-30|04/2020||||
2525984|NCT03725982|Secondary|Self-developed Participant Evaluation Questionnaire|"This questionnaire will consist of questions about usability and acceptance of the intervention (the Laevo device), stemming from standardized questions from existing questionnaires, including:~the System Usability Scale (SUS): 10 statements about subjective perception of interaction with the Laevo system to be evaluated on a scale ranging from 1 (disagree) to 5 (agree);~the Technology Usage Inventory (TUI): 30 statements on technology-specific and psychological factors with respect to the Laevo to be evaluated on a scale ranging from 1 (not true) to 7 (true); of these 30 questions, the investigators include only 7 statements belonging to the domains 'usability' and 'skepticism'."|Directly after the experiment (~2.5 hours)||2020-04-30|04/2020||||
2525985|NCT03725982|Secondary|Heart Rate|Continuous recording electrocardiography allows calculating the heart rate, a parameter reflecting the central stress state of the participant. The average heart rate will be calculated per time period.|Average heart activity over time period baseline (0 min) to directly after (1.5 min) the experimental condition||2020-04-30|04/2020||||
2525986|NCT03725982|Secondary|Spinal Curvature|The spinal curvature can be determined using position sensors placed on the spine, i.e. on vertebrae T1, T10, L1 and L5. Using these four position sensors, the lumbar lordosis (lower back curvature) and thoracic kyphosis (upper back curvature) can be calculated.|Average lordosis and kyphosis over time period baseline (0 min) to directly after (1.5 min) the experimental condition||2020-04-30|04/2020||||
2525987|NCT03725982|Secondary|Knee Compression Force|"Calculated using 2D inverse modelling with continuous recordings from position sensors (for position and angular accelerations) and a force plate (for ground reaction forces).~The average knee compression force will be calculated over each experimental condition"|Average calculated knee compression force over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition||2020-04-30|04/2020||||
2525988|NCT03725982|Secondary|Root-mean-square of Electrical Muscle Activity Recordings of Leg, Back and Shoulder Muscles Using Electromyography|Selected target muscles in the leg (gastrocnemius medialis, vastus medialis, biceps femoris), shoulder (trapezius) and back (erector spinae lumbalis, rectus abdominis) will be continuously recorded with electromyography. From the electromyographic signal, the root-mean-square will be calculated and averaged over the time period of each experimental condition.|Average root-mean-square of muscle activity over the time period running from baseline (0 min) to directly after (1.5 min) the experimental condition||2020-04-30|04/2020||||
2525989|NCT03725982|Primary|Rating of Perceived Discomfort (RPD)|Discomfort (RPD) was assessed using an 11-point numeric rating scale (NRS), ranging from 0 (no discomfort at all) to 10 (maximally imaginable discomfort). It was assessed directly before (0 min) and directly after (1.5 min) each experimental condition. The experimental conditions consisted of either static or dynamic tasks, that lasted up to 1.5 minutes.|Change from baseline (0 min) to directly after (1.5 min) both experimental conditions||||units on a scale||Standard Deviation|Mean
2525990|NCT03725098|Secondary|5 Minute Hemostasis - Hemostatic Success (Yes/no) at 5 Minutes|The secondary endpoint of this study is non-inferiority of HEMOBLAST™ relative to FLOSEAL for the proportion of subjects reaching hemostasis within 5 minutes.|Intraoperative||||Participants|||Count of Participants
2526060|NCT03717064|Secondary|Period 1: Cmax of Pitavastatin Lactone||Period 1 Day 1||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2525992|NCT03725085|Secondary|Overall Assessment of the Study Medication by End of Study Investigator Questionnaire|"End of Study Investigator Questionnaire is a questionnaire provided at the end of study visit to the investigator (or sub-investigator as applicable) for overall assessment of the study medication across all patients treated by them.~End of study investigator questionnaire was collected from 9 investigators.~Mostly Satisfied(MS) Satisfied(Stfd) Very Satisfied(VS) Chest Congestion(CC) Chesty Cough(CCO) Difference(Diff) Between(b/w) Somewhat Agree(SA) Strongly Agree(StA) Upper respiratory tract infection(URTI) Optimal dosage(Opt dos) Cough preparations Available(CPA)"|Up to Day 9|Safety Population: All patients enrolled in the study were included for safety analyses.|||Number of investigator|||Number
2525993|NCT03725085|Secondary|Overall Assessment of the Study Medication by End of Study Patient Questionnaire|"End of Study Patient Questionnaire is a questionnaire provided to the patients for overall assessment of the study medication at the end of study visit.~Satisfied(stfd) Dissatisfied(Dstfd)"|Up to Day 9|Safety Population: All patients enrolled in the study were included for safety analyses.|||Participants|||Count of Participants
2525994|NCT03725085|Primary|Number of Adverse Events by Severity, Seriousness and the Relationship of AE(s) to Treatment|"Intensity determined. Mild = AE did not limit usual activities; subject may have experienced slight discomfort.~Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort.~Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain.~Relationship to Investigational Medicinal Products (IMP) Unassessable/Unclassified = Insufficient information to be able to make an assessment Conditional/ Unclassified = Insufficient information to make an assessment at present Unrelated = No possibility that the AE was caused by the IMP Unlikely = Slight, but remote, chance that the AE was caused by the IMP, but the balance of judgment was that it was most likely not due to the IMP.~Possible = Reasonable suspicion that the AE was caused by the IMP Probable = Most likely that the AE was caused by the IMP Certain = AE was definitely caused by the IMP"|Up to Day 9|Safety Population: All patients enrolled in the study were included for safety analyses.|||Number of Events|||Number
2525995|NCT03725085|Primary|Number of Subjects Affected With Adverse Events|Proportion of patients with AE(s) - Number of Subjects affected with Events|Up to Day 9|Safety Population: All patients enrolled in the study were included for safety analyses.|||Number of Subjects affected with Events|||Number
2525996|NCT03725085|Primary|Number of Adverse Events (AEs), Type of AE(s) and Frequency of AE(s)|"Treatment Emergent Adverse Event (TEAE) are events occurring after the first dose of study medication.~Frequency of AE(s) - the total Number of Events~Type of AE(s) - Serious TEAE and Non serious TEAE"|Up to Day 9|Safety Population: All patients enrolled in the study were included for safety analyses.|||Number of Events|||Number
2525997|NCT03724981|Secondary|Participant Preference Between 2 Injection Devices Based on Ease of Use|"Participants responded to the Diabetes Injection Device - Preference Questionnaire (DID-PQ), Item 9 (ease of use) to compare the dulaglutide and semaglutide devices with regard to ease. Response options of strongly prefer and prefer were combined for each device, resulting in 3 categories: prefer dulaglutide, prefer semaglutide, and no preference. The Prescott test will be run to examine if a statistically significant difference in preference between the devices exists while, controlling for order effects."|Day 1|All randomized participants with exposure to both devices and Ease of Use data.|||percentage of participants|||Number
2525998|NCT03724981|Primary|Participant Preference Between 2 Injection Devices Based on Global Preference Item|"Preference of injection device was assessed by questionnaire which asks, Overall, which device do you prefer? The Prescott test will be run to examine if a statistically significant difference in preference between the devices exits, while controlling for order effects and taking into account the neutral responses."|Day 1|All randomized participants with exposure to both devices and Global Preference data.|||percentage of participants|||Number
2525999|NCT03724877|Secondary|The Rate of COPD Exacerbations Over the One-year Follow-up|This outcome was based on the number of hospitalizations and on the number of courses of treatment with an oral corticosteroid. A gap of at least 30 days between treatment courses was required to consider the exacerbations as separate events.|1 year|The main analysis was on matched patients. The cohort of initiators of LAMA-LABA-ICS and their propensity score-matched initiators of LAMA-LABA.|||exacerbations per 100 person year|||Number
2526000|NCT03724877|Primary|Number of Participants Hospitalised With Community-acquired Pneumonia (Serious Pneumonia)|The primary outcome event for safety was the occurrence of the first hospitalization for community-acquired pneumonia (serious pneumonia).|1 year|The main analysis was on matched patients. The cohort of initiators of LAMA-LABA-ICS and their propensity score-matched initiators of LAMA-LABA.|||Participants|||Count of Participants
2526001|NCT03724877|Primary|Number of Participants Hospitalised With Moderate Exacerbation|The primary outcome event for effectiveness was the first COPD exacerbation to occur after cohort entry. The event was defined as a hospitalization with the prescription of an oral corticosteroid, namely prednisolone (moderate exacerbation) is presented.|1 year|The main analysis was on matched patients. The cohort of initiators of LAMA-LABA-ICS and their propensity score-matched initiators of LAMA-LABA.|||Participants|||Count of Participants
2526002|NCT03724877|Primary|Number of Participants Hospitalised With Severe Exacerbation|The primary outcome event for effectiveness was the first COPD exacerbation to occur after cohort entry. The event was defined as a hospitalization with a primary diagnosis of COPD (severe exacerbation) is presented.|1 year|The main analysis was on matched patients. The cohort of initiators of LAMA-LABA-ICS and their propensity score-matched initiators of LAMA-LABA.|||Participants|||Count of Participants
2526003|NCT03723980|Other Pre-specified|Difference of Pain Scores Between Different Age Groups|"Information about Visual Analogue Scale for rating pain scores:~minimum pain score on this scale is 0 and maximum is 100~more the pain score; worse the pain~mean pain score difference between different age groups: 20 to 24; 25 to 29; 30 to 34; and 35 to 40 at different time intervals was assessed~scale is divided into 4 segments: 0 to 24 (no or mild pain), 25 to 49 (moderate pain), 50 to 74 (severe pain); 75 to 100 (extreme pain)."|4 hours, 12 hours, day 2, day 3, and day 4||||score on a scale||Standard Deviation|Mean
2526061|NCT03717064|Secondary|Period 2: AUC-tau of RO7049389||Period 2 Days 3-4||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2526062|NCT03717064|Secondary|Period 2: Cmax of RO7049389||Period 2 Days 3-4||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2540733|NCT03042559|Secondary|Iliotibial Band Flexibility|To assess the flexibility of iliotibial band|4 weeks||||degree||Standard Deviation|Mean
2526004|NCT03723980|Other Pre-specified|Difference of Pain Scores Between Males and Females|"Information about Visual Analogue Scale for rating pain scores:~minimum pain score on this scale is 0 and maximum is 100~more the pain score; worse the pain~mean pain score difference between males and females at different time intervals was assessed~scale is divided into 4 segments: 0 to 24 (no or mild pain), 25 to 49 (moderate pain), 50 to 74 (severe pain); 75 to 100 (extreme pain)."|4 hours, 12 hours, day 2, day 3, and day 4||||score on a scale||Standard Deviation|Mean
2526005|NCT03723980|Secondary|Difference of Pain Score Between Different Time Intervals|"Visual Analogue Pain Score information:~pain intensity is measured with this scale~minimum pain score reading on Visual Analogue Scale is 0 and Maximum is 100~higher values represent worse pain and lower values represent lesser pain~this pain score is recorded pre-operatively, then at time intervals of 4 hours, 12 hours, day 2, day 3 and day 4.~the comparison of mean pain scores of different time intervals will be made."|4 hours, 12 hours, day 2, day 3, and day 4||||score on a scale||Standard Error|Mean
2526006|NCT03723980|Secondary|Acute Increase in Pain Score (Acute Exacerbation of Pain)|"An increase of 20 or more points on Visual Analogue Pain Scale from pain score of previous time interval~Information about the Visual Analogue Scale:~it consists of pain score from 0 to 100.~The higher the pain score; the worse the pain~An increase of a total of at least 20 pain score points from previous pain score reading indicate that pain has increased significantly and will be reported as flare-up"|4 hours, 12 hours, day 2, day 3, and day 4|Out of 80 patients, 12 did not return for follow-up; and no contact could be established with them. Out of these 12 patients, 7 belong to control group and 5 belong to experimental group. Hence, 33 patients in control group and 35 patients in experimental group could be analyzed|||Participants|||Count of Participants
2526007|NCT03723980|Primary|Pain Intensity Measure: Visual Analogue Pain Scale|"Self recorded pain intensity by the patients at 4 hours, 12 hours, day 2, day 3 and day 4 after root canal preparation and intracanal medicament insertion (first visit). Pain intensity recorded on a Visual Analogue Scale from 0 to 100. Patients who experience no or mild pain; and do not require analgesic will record their pain intensity from 0 to 24. Patients who experience moderate pain; and require Over-the-counter analgesic will record pain intensity from 25 to 49. Patients who experience severe pain; and require use of codeine containing medicine will record their pain intensity from 50 to 74. Patients who experience extreme pain, and no medicine is able to relieve their pain will record pain intensity from 75 to 100.~lower pain score (intensity) is a better outcome as compared to higher pain intensity (score)"|4 hours, 12 hours, day 2, day 3 and day 4|Out of 80 patients, 12 did not return for follow-up; and no contact could be established with them. Out of these 12 patients, 7 belong to control group and 5 belong to experimental group. Hence, 33 patients in control group and 35 patients in experimental group could be analyzed|||score on a scale||Standard Deviation|Mean
2526008|NCT03723603|Secondary|Change in Reported Pain Level|The pain score will be recorded with a verbal numeric pain rating scale from 0-10.|Baseline to 84 days|Study terminated prematurely due to re-prioritization of study efforts. Data not assessed.||||||
2526009|NCT03723603|Secondary|Change in Bates-Jensen Wound Assessment Tool|The Bates-Jensen Wound Assessment tool score will be used to assess the wound's status throughout the study. The Bates-Jensen Wound Assessment tool measures wound status. The wound size score ranges from 0 to 5. The wound depth score ranges from 0 to 5. The wound edge score ranges from 0 to 5. The wound undermining score ranges from 0 to 5. The necrotic tissue type score ranges from 1 to 5. The necrotic tissue amount ranges from 1 to 5. The exudate type score ranges from 1 to 5. The exudate amount score ranges from 1 to 5. The skin color surrounding wound score ranges from 1 to 5. The peripheral tissue edema score ranges from 1 to 5. The peripheral tissue induration score score ranges from 1 to 5. The granulation tissue score ranges from 1 to 5. The epithelialization score ranges from 1 to 5. The total score from these sub-scores added together is used as the total BWAT score. For all sub-score values, a value of 0 or 1 is a better outcome.|Baseline to 84 days|Study terminated prematurely due to re-prioritization of study efforts. Data not assessed.||||||
2526010|NCT03723603|Primary|Change in Wound Size Over Twelve Week Period||Baseline to 84 days|Study terminated prematurely due to re-prioritization of study efforts. Data not assessed.||||||
2526011|NCT03722264|Secondary|Retention of OpalSeal|The protective effects of OpalSeal is subject to its retention at the site of application. Since OpalSeal fluoresces under black light, its retention will be evaluated|Time from initial bonding to extraction (max 90 days)|TransbondXT retention cannot be assessed so no control teeth were analyzed. Only 5 teeth on which OpalSeal was applied were analyzed|||percent coverage||Full Range|Median
2526012|NCT03722264|Secondary|Surface Topography and Hardness|Scanning electron microscopy and atomic force microscopy will be used to evaluate the protective effect of OpalSeal|Time from initial bonding to extraction (max 90 days)|Data could not be collected for this variable.||||||
2526013|NCT03722264|Primary|Loss of Mineral Density in the Enamel|Teeth will be subjected to microCT to assess the extent of demineralization. Loss of mineral density will be measured as depth of lesions|Time from initial bonding to extraction (max 90 days)|9 teeth in each group were available for analysis|||microns|teeth|Full Range|Mean
2526014|NCT03721549|Secondary|Frequency of Serious Adverse Events (SAEs)|Occurrence of SAEs|42 ± 3 days post-challenge||||Participants|||Count of Participants
2526015|NCT03721549|Primary|Frequency of Norovirus Gastroenteritis (NVG)|Occurrence of NVG within 7 days post-challenge|7 days post-challenge||||Participants|||Count of Participants
2526016|NCT03720938|Secondary|Enjoyment Levels by Physical Activity of Genders From Training Category in the Game Group|"For Training category, there were 9 games of rhythm kung fu, snowball, turning ball, Segway circuit, perfect 10, skateboard, major, obstacle course and bicycle. Thus, each child was evaluated after every single game by five bipolar scale questions. Questions 1 and 4 were starting from positive to negative answers (left to right) and therefore scored as 7-1. Scale scores were determined by calculating the mean. All scale scores were summed to calculate the Category score. The higher the score, the better the enjoyment in this category.~Min-Max Training Category scores were 31.6-41.8 for females and 29.2-45.2 for males."|After every game during 12 weeks||||score on a scale||Standard Deviation|Mean
2526110|NCT03714672|Secondary|Subject's Global Evaluation of the Treatment|Participants documented their overall impression of the analgesic efficacy of the IMPs on a 5-point Likert scale from Excellent (4) to Poor (0).|8 hours after the first dose of IMP or before first intake of rescue medication (whatever the first) and 24 hours after the first dose of IMPs|Full Analysis Set|||Participants|||Count of Participants
2526017|NCT03720938|Secondary|Enjoyment Levels by Physical Activity of Genders From Aerobic Category in the Game Group|"For Aerobics category, there were 5 games of rhytmic boxing, hula-hoop, cycling, step, and run. Thus, each child was evaluated after every single game by five bipolar scale questions. Questions 1 and 4 were starting from positive to negative answers (left to right) and therefore scored as 7-1. Scale scores were determined by calculating the mean. All scale scores were summed to calculate the Category score. The higher the score, the better the enjoyment in this category.~Min-Max Aerobics Category scores were 17.8-24 for females and 14.4-26.4 for males."|After every game during 12 weeks||||score on a scale||Standard Deviation|Mean
2526018|NCT03720938|Secondary|Enjoyment Levels by Physical Activity of Genders From Balance Category in the Game Group|"For Balance category, there were 5 games of ski slalom, heading ball, balance bubble, ski jumping and penguin playing. Thus, each child was evaluated after every single game by five bipolar scale questions. Questions 1 and 4 were starting from positive to negative answers (left to right) and therefore scored as 7-1. Scale scores were determined by calculating the mean. All scale scores were summed to calculate the Category score. The higher the score, the better the enjoyment in this category.~Min-Max Balance Category scores were 14.4-23.2 for females and 15-26.6 for males."|After every game during 12 weeks||||score on a scale||Standard Deviation|Mean
2526019|NCT03720938|Secondary|Enjoyment Levels of Genders From Resort Category in the Game Group by Physical Activity|"For Resort category, there were 8 games of jet-skiing, water skiing, table tennis, basketball, swordplay, archery, canoeing and frisbee. Thus, each child was evaluated after every single game by five bipolar scale questions. Questions 1 and 4 were starting from positive to negative answers (left to right) and therefore scored as 7-1. Scale scores were determined by calculating the mean. All scale scores were summed to calculate the Category score. The higher the score, the better the enjoyment in this category.~Min-Max Resort Category scores were 23.2-37 for females and 25.8-37.8 for males."|After every game during 12 weeks||||score on a scale||Standard Deviation|Mean
2526020|NCT03720938|Secondary|Enjoyment Levels of Genders From Sports Category in the Game Group by Physical Activity Enjoyment Scale (PACES-SF)|"For Sports category, there were 5 games of boxing, tennis, golf, baseball, and bowling. Thus, each child was evaluated after every single game by five bipolar scale questions. Questions 1 and 4 were starting from positive to negative answers (left to right) and scored as 7-1. Scale scores were determined by calculating the mean. All scale scores were summed to calculate the Category score. The higher the score, the better the enjoyment in this category.~Min-Max Sports Category scores were 11-25 for females and 17.8-26.2 for males."|After every game during 12 weeks|Enjoyment levels only in the intervention group were assessed since control group did not play the games of interest.|||score on a scale||Standard Deviation|Mean
2526021|NCT03720938|Secondary|Self-perception of Global Self-worth Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)|"The scale Children and Youth Physical Self Perception Profile (CY-PSPP) assessed the children's self-percetion about global self-worth subscale in both groups at the beginning and at the end of protocol. The subscale was assessed by 6 questions with four ordinal levels (1-4) of response. Minimum and maximum total scores change between 6 to 24 for the subscale. Higher scores mean a better score."|Baseline, 12 weeks||||score on a scale||Standard Deviation|Mean
2526022|NCT03720938|Secondary|Self-perception of Global Physical Self-worth Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)|"The scale Children and Youth Physical Self Perception Profile (CY-PSPP) assessed the children's self-percetion about physical self-worth subscale in both groups at the beginning and at the end of protocol. The subscale was assessed by 6 questions with four ordinal levels (1-4) of response. Minimum and maximum total scores change between 6 to 24 for the subscale. Higher scores mean a better score."|Baseline, 12 weeks||||score on a scale||Standard Deviation|Mean
2526023|NCT03720938|Secondary|Self-perception of Body Attractiveness Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)|"The scale Children and Youth Physical Self Perception Profile (CY-PSPP) assessed the children's self-percetion about body attractiveness subscale in both groups at the beginning and at the end of protocol. The subscale was assessed by 6 questions with four ordinal levels (1-4) of response. Minimum and maximum total scores change between 6 to 24 for the subscale. Higher scores mean a better score."|Baseline, 12 weeks||||score on a scale||Standard Deviation|Mean
2526024|NCT03720938|Secondary|Self-perception of Strength Competence Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)|"The scale Children and Youth Physical Self Perception Profile (CY-PSPP) assessed the children's self-percetion about strength competence subscale in both groups at the beginning and at the end of protocol. The subscale was assessed by 6 questions with four ordinal levels (1-4) of response. Minimum and maximum total scores change between 6 to 24 for the subscale. Higher scores mean a better score."|Baseline, 12 weeks||||score on a scale||Standard Deviation|Mean
2526025|NCT03720938|Secondary|Self-perception of Physical Condition Competence Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)|"The scale Children and Youth Physical Self Perception Profile (CY-PSPP) assessed the children's self-percetion about physical condition competence subscale in both groups at the beginning and at the end of protocol. The subscale was assessed by 6 questions with four ordinal levels (1-4) of response. Minimum and maximum total scores change between 6 to 24 for the subscale. Higher scores mean a better score."|Baseline, 12 weeks||||score on a scale||Standard Deviation|Mean
2526026|NCT03720938|Secondary|Self-Perception of Sports Competence Assessed by Children and Youth Physical Self-perception Profile (CY-PSPP)|"The scale Children and Youth Physical Self Perception Profile (CY-PSPP) assessed the children's self-percetion about sports competence subscale in both groups at the beginning and at the end of protocol. The subscale was assessed by 6 questions with four ordinal levels (1-4) of response. Minimum and maximum total scores change between 6 to 24 for the subscale. Higher scores mean a better score."|Baseline, 12 weeks||||score on a scale||Standard Deviation|Mean
2526027|NCT03720938|Secondary|Auditory Reaction Time of Non-dominant Hand by Newtest 1000 Timer||Baseline, 12 weeks||||seconds||Standard Deviation|Mean
2526028|NCT03720938|Secondary|Auditory Reaction Time of Dominant Hand by Newtest 1000 Timer||Baseline, 12 weeks||||seconds||Standard Deviation|Mean
2526029|NCT03720938|Secondary|Visual Reaction Times of Non-dominant Hand by Newtest 1000 Timer||Baseline, 12 weeks||||seconds||Standard Deviation|Mean
2526030|NCT03720938|Secondary|Visual Reaction Times of Dominant Hand by Newtest 1000 Timer|Determination of visual reaction times after games in intervention groups, and control groups. First before the games, second after the games.|Baseline, 12 weeks||||seconds||Standard Deviation|Mean
2526031|NCT03720938|Primary|Body Fat Percentage as Determined by Siri Formula From Skinfold Thicknesses|The biceps, triceps, suprailiac and subscapular regions skinfold thicknesses were measured by Holtain caliper at the beginning of and after the games. Durnin-Womersley formula was used to calculate body densities. Then fat ratio of whole body was derived from the Siri equation by integrating body densities obtained by Durnin-Womersley formula.|Baseline, 12 weeks||||percentage of fat||Standard Deviation|Mean
2526032|NCT03720938|Primary|BMI z Score|Weight and height were measured to the nearest 0.01 kg (Seca 767) and 0.1 cm (Seca 220). BMI Z-scores were calculated using national data for Turkish children derived from values obtained from calculations with Quetelet index. The first before the games, the second after the games. Positive BMI z-scores indicates the number of standard deviations of the child above the mean of the population of the same age, whereas negative z-scores indicates the number of standard deviations of the child below the mean of the population of the same age.|Baseline, 12 weeks||||units on a scale||Standard Deviation|Mean
2526033|NCT03720938|Primary|"BMI Calculated as Weight (kg) / Height (m^2)"|Body Mass Index calculation of both groups before the games and after the games.|Baseline, 12 weeks||||kg/ m^2||Standard Deviation|Mean
2526034|NCT03720938|Primary|Weight z Score|Weight measured to the nearest 0.01 kg by Seca 767 scale. Z scores were calculated using national data for Turkish children. The first before the games, the second after the games. Positive z-scores indicates the number of standard deviations of the child above the mean of the population of the same age, whereas negative z-scores indicates the number of standard deviations of the child below the mean of the population of the same age.|Baseline, 12 weeks||||units on a scale||Standard Deviation|Mean
2526035|NCT03720938|Primary|Weight in Kilograms|Weight measured to the nearest 0.01 kg by Seca 767 scale. The first before the games, the second after the games.|Baseline, 12 weeks||||kg||Standard Deviation|Mean
2526036|NCT03720847|Secondary|Perimenstrual Change in State Self-Esteem Scale Social Evaluation Subscale (SSES-SE) Score|The SSES-SE (State Self-Esteem Scale Social Evaluation subscale) includes 7 items that ask the person assessed to report his or her experience of social self-esteem--that is, a sense that others are evaluating one in a positive light-- in the present moment. Instructions were modified such that symptoms were rated over the past week (rather than the standard 2 weeks). This measure will be collected at the second lab visit in each condition (day 7 following ovulation). Scores can range from 7 to 49. Higher scores are considered better as they indicate better social self-esteem. Perimenstrual change scores are calculated for each person in a given condition as the person's score at lab 2 (in the perimenstrual phase) minus the person's score at lab 1 (midluteal phase). Therefore, positive values represent degree of perimenstrual increase in self-esteem, and negative values represent degree of perimenstrual decrease.|Day 7 of Each Condition (Lab 2)|All participants who were exposed to either condition.|||units on a scale||Standard Deviation|Mean
2526037|NCT03720847|Secondary|Perimenstrual Changes in Patient-Reported Outcomes Measurement Information Systems (PROMIS) Anxiety Scale Score|The PROMIS (Patient-Reported Outcomes Measurement Information Systems) Anxiety scale includes 7 items that ask the person assessed to report his or her experience of anxiety over the past two weeks. Instructions were modified such that symptoms were rated over the past week (rather than the standard 2 weeks). This measure will be collected at the second lab visit in each condition (day 7 following ovulation). Scores can range from 7 to 35. Higher scores are considered worse. Perimenstrual change scores are calculated for each person in a given condition as the person's score at lab 2 (in the perimenstrual phase) minus the person's score at lab 1 (midluteal phase). Therefore, positive values represent degree of perimenstrual increase in symptoms, and negative values represent degree of perimenstrual decrease.|Day 7 of Each Condition (Lab 2)||||units on a scale||Standard Deviation|Mean
2526038|NCT03720847|Secondary|"Perimenstrual Change in Lack of Premeditation Subscale Score of the Urgency, Premeditation, Perseverance, Sensation Seeking, and Positive Urgency (UPPSP) Impulsivity Scale"|The UPPS-P (Urgency, Premeditation, Perseverance, Sensation Seeking, Positive Urgency Impulsivity Scale) Lack of Premeditation subscale includes 11 items that ask the person to report experience of impulsivity over the past two weeks. Instructions were modified such that symptoms were rated over the past week (rather than the standard 2 weeks). This measure will be collected at the second lab visit in each condition (day 7 following ovulation). Scores can range from 11 to 44. Higher scores are considered worse. Perimenstrual change scores are calculated for each person in a given condition as the person's score at lab 2 (in the perimenstrual phase) minus the person's score at lab 1 (midluteal phase). Therefore, positive values represent degree of perimenstrual increase in symptoms, and negative values represent degree of perimenstrual decrease.|Day 7 of Each Condition (Lab 2)|All participants who were exposed to either condition.|||units on a scale||Standard Deviation|Mean
2526039|NCT03720847|Secondary|Perimenstrual Change in Center for Epidemiological Studies Depression Scale (CES-D) Score|The Center for Epidemiological Studies Depression scale (CES-D) includes 20 items that ask the person assessed to report his or her experience of mood symptoms. Instructions were modified such that symptoms were rated over the past week (rather than the standard 2 weeks). This measure will be collected at the second lab visit in each condition (day 7 following ovulation). Scores can range from zero to 60, with most persons attaining a score of 15 or less. Higher scores are considered worse. Perimenstrual change scores are calculated for each person in a given condition as the person's score at lab 2 (in the perimenstrual phase) minus the person's score at lab 1 (midluteal phase). Therefore, positive values represent degree of perimenstrual increase in symptoms, and negative values represent degree of perimenstrual decrease.|Day 7 of Each Condition (Lab 2)|All participants who were exposed to either condition.|||units on a scale||Standard Deviation|Mean
2526040|NCT03720847|Secondary|Perimenstrual Change in Beck Hopelessness Scale (BHS) Score|Hopelessness is assessed with the Beck Hopelessness Scale, a 20-item self-report measure with true-false items that assess hopelessness and the extent of positive and negative beliefs about the future. This measure will be collected at the second lab visit in each condition (day 7 following ovulation). Summed scores range from 0 to 20. Scores provide a measure of the severity of self-reported hopelessness: 0-3 minimal, 4-8 mild, 9-14 moderate, and 15-20 severe. Higher values on the raw scale represent greater hopelessness. Perimenstrual change scores are calculated for each person in a given condition as the person's score at lab 2 (in the perimenstrual phase) minus the person's score at lab 1 (midluteal phase). Therefore, positive values represent degree of perimenstrual increase in symptoms, and negative values represent degree of perimenstrual decrease.|Day 7 of Each Condition (Lab 2)|All participants who were exposed to either condition.|||units on a scale||Standard Deviation|Mean
2526041|NCT03720847|Primary|Perimenstrual Change in Self-Injurious Thoughts and Behaviors Interview (SITBI) Suicidal Planning Score|"The SITBI is an interview designed to assess various aspects of suicidality. This outcome is a single item representing suicidal planning from the SITBI interview was measured as part of a daily questionnaire via smart phone. The question was: Today, how seriously did you consider acting on a suicide plan?. Each day, individuals chose a response from 0 (Not at All) to 4 (Severe). Values could range from 0 to 4, and higher values indicate more suicidal planning. Perimenstrual change scores are calculated for each person in a given condition as the mean of scores in the perimenstrual phase (final seven days of medication use in that condition) minus the mean in the midluteal phase (7 days starting on the day of the positive ovulation test for that condition). Therefore, positive values represent a perimenstrual increase in symptoms, and negative values represent a perimenstrual decrease."|Midluteal Baseline and Perimenstrual|All participants who were exposed to either condition.|||units on a scale||Standard Deviation|Mean
2526042|NCT03720847|Primary|Perimenstrual Change in Self-Injurious Thoughts and Behaviors Interview (SITBI) Suicidal Ideation Score|"The SITBI is an interview designed to assess various aspects of suicidality, including ideation, planning, intent, and behavior. This outcome is a single item representing suicidal ideation severity from the SITBI interview which was measured as part of a daily questionnaire completed via smart phone. The question was: Today, how intense were your thoughts of killing yourself?. Each day, individuals chose a response ranging from 0 (Not at All) to 4 (Severe). Values could range from 0 to 4, and higher values indicate more suicidal ideation. Perimenstrual change scores are calculated for each person in a given condition as the mean of scores in the perimenstrual phase (final seven days of medication use in that condition) minus the mean in the midluteal phase (7 days starting on the day of the positive ovulation test for that condition). Therefore, positive values represent a perimenstrual increase in symptoms, and negative values represent a perimenstrual decrease in symptoms."|Midluteal Baseline and Perimenstrual|All participants who were exposed to either condition.|||units on a scale||Standard Deviation|Mean
2526043|NCT03720119|Secondary|Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)|Evaluation of incidence and severity of AEs and SAEs in all patients entered in the study|15 days, starting from informed consent signature up to the end of the study||||Participants|||Count of Participants
2526044|NCT03720119|Primary|Change of Pain Intensity From Baseline to the End of Treatment Using the 11-point Numerical Pain Rating Scale (NPRS)|"The evaluation of the pain intensity was based on a 11-point Numerical Pain Rating Scale (NPRS score from 0= no pain to 10= the most intense pain imaginable). Patients recorded the NPRS score every day of treatment in their diary.~The improvement in the pain intensity is defined as a decrease in NPRS scores from baseline to the end of treatment."|Every day for 15 days|The degree of pain intensity was recorded by patients on daily diary and revised by Investigators at final visit.|||Score on a scale||Standard Deviation|Mean
2526045|NCT03720119|Primary|Change of Pain Relief From Baseline to the End of Treatment Using the 5-point Visual Rating Scale (VRS)|"The evaluation of wound pain relief was based on a 5-point Visual Rating Scale (0 = none improvement; 4 = total relief).~Patients recorded the VRS score every day of treatment in their diary. The improvement in the pain relief was defined as a VRS scores at end of treatment significantly greater than 0."|Every day for 15 days|There are missing data in some time-points|||Participants|||Count of Participants
2526046|NCT03718000|Secondary|Concentration of Blood Total Cholesterol (TC) (mg/dL)|Fasting blood draw|Measured at 3 testing visits: Visit 1 (pre-holiday visit) occurred within 7 days before Thanksgiving, visit 2 (post-holiday visit) occurred within 7 days after New Year's Day, and visit 3 (follow-up visit) occurred 14 weeks after visit 2.||||mg/dL||Standard Deviation|Mean
2526047|NCT03718000|Secondary|Concentration of Blood Low-density Lipoprotein (LDL) (mg/dL)|Fasting blood draw|Measured at 3 testing visits: Visit 1 (pre-holiday visit) occurred within 7 days before Thanksgiving, visit 2 (post-holiday visit) occurred within 7 days after New Year's Day, and visit 3 (follow-up visit) occurred 14 weeks after visit 2.||||mg/dL||Standard Deviation|Mean
2526048|NCT03718000|Secondary|Concentration of Blood High-density Lipoprotein (HDL) (mg/dL)|Fasting blood draw|Measured at 3 testing visits: Visit 1 (pre-holiday visit) occurred within 7 days before Thanksgiving, visit 2 (post-holiday visit) occurred within 7 days after New Year's Day, and visit 3 (follow-up visit) occurred 14 weeks after visit 2.||||mg/dL||Standard Deviation|Mean
2526049|NCT03718000|Secondary|Concentration of Blood Triglyceride (mg/dL)|Fasting blood draw|Measured at 3 testing visits: Visit 1 (pre-holiday visit) occurred within 7 days before Thanksgiving, visit 2 (post-holiday visit) occurred within 7 days after New Year's Day, and visit 3 (follow-up visit) occurred 14 weeks after visit 2.||||mg/dL||Standard Deviation|Mean
2526050|NCT03718000|Secondary|Hip Circumference (cm)|Measuring tape|Measured at 3 testing visits: Visit 1 (pre-holiday visit) occurred within 7 days before Thanksgiving, visit 2 (post-holiday visit) occurred within 7 days after New Year's Day, and visit 3 (follow-up visit) occurred 14 weeks after visit 2.||||cm||Standard Deviation|Mean
2526051|NCT03718000|Secondary|Waist Circumference (cm)|Measuring tape|Measured at 3 testing visits: Visit 1 (pre-holiday visit) occurred within 7 days before Thanksgiving, visit 2 (post-holiday visit) occurred within 7 days after New Year's Day, and visit 3 (follow-up visit) occurred 14 weeks after visit 2.||||cm||Standard Deviation|Mean
2526052|NCT03718000|Secondary|Body Fat (%)|Dual Energy X-Ray Absorptiometry|Measured at 3 testing visits: Visit 1 (pre-holiday visit) occurred within 7 days before Thanksgiving, visit 2 (post-holiday visit) occurred within 7 days after New Year's Day, and visit 3 (follow-up visit) occurred 14 weeks after visit 2.||||Percentage of body fat||Standard Deviation|Mean
2526053|NCT03718000|Secondary|Body Mass Index (BMI) (kg/m^2)|weight and height will be combined to report BMI in kg/m^2|Measured at 3 testing visits: Visit 1 (pre-holiday visit) occurred within 7 days before Thanksgiving, visit 2 (post-holiday visit) occurred within 7 days after New Year's Day, and visit 3 (follow-up visit) occurred 14 weeks after visit 2.||||kg/m^2||Standard Deviation|Mean
2526054|NCT03718000|Primary|Change in Body Weight (kg) From Pre- to Post-holiday and 14-week Follow-up Post-holiday|Mechanical Beam Scale (Model 402KL, Health o Meter professional scales, McCook, IL, USA); Capacity: 390 lbs / 180 kg; Readability: 1/4 lb / 100 g.|Measured at 3 testing visits: Visit 1 (pre-holiday visit) occurred within 7 days before Thanksgiving, visit 2 (post-holiday visit) occurred within 7 days after New Year's Day, and visit 3 (follow-up visit) occurred 14 weeks after visit 2.||||kg||Standard Deviation|Mean
2526055|NCT03717064|Secondary|Period 2: AUC Ratio of Pitavastatin Lactone to Pitavastatin||Period 2 Day 4||||Ratio||90% Confidence Interval|Geometric Mean
2526063|NCT03717064|Secondary|Percentage of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|From the start of Period 1 through safety follow-up (Period 2, Day 34)||||Percentage of Participants|||Number
2526064|NCT03717064|Primary|Period 2: Elimination Half-Life (T1/2) of Pitavastatin||Period 2 Day 4||||h||Geometric Coefficient of Variation|Geometric Mean
2526065|NCT03717064|Primary|Period 2: Volume of Distribution (V/F) of Pitavastatin||Period 2 Day 4||||L||Geometric Coefficient of Variation|Geometric Mean
2526066|NCT03717064|Primary|Period 2: Apparent Total Clearance (CL/F) of Pitavastatin||Period 2 Day 4||||L/h||Geometric Coefficient of Variation|Geometric Mean
2526067|NCT03717064|Primary|Period 2: Time to Maximum Concentration (Tmax) of Pitavastatin||Period 2 Day 4||||h||Full Range|Median
2526068|NCT03717064|Primary|Period 2: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin||Period 2 Day 4||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2526069|NCT03717064|Primary|Period 2: Maximum Plasma Concentration (Cmax) of Pitavastatin||Period 2 Day 4||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2526070|NCT03717064|Primary|Period 1: Elimination Half-Life (T1/2) of Pitavastatin||Period 1 Day 1||||h||Geometric Coefficient of Variation|Geometric Mean
2526071|NCT03717064|Primary|Period 1: Volume of Distribution (V/F) of Pitavastatin||Period 1 Day 1||||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
2526072|NCT03717064|Primary|Period 1: Apparent Total Clearance (CL/F) of Pitavastatin||Period 1||||L/h||Geometric Coefficient of Variation|Geometric Mean
2526073|NCT03717064|Primary|Period 1: Time to Maximum Concentration (Tmax) of Pitavastatin||Period 1 Day 1||||hours (h)||Full Range|Median
2526074|NCT03717064|Primary|Period 1: Plasma Concentration Versus Time (Area Under the Curve, AUC0-inf) of Pitavastatin||Period 1 Day 1||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2526075|NCT03717064|Primary|Period 1: Maximum Plasma Concentration (Cmax) of Pitavastatin||Period 1 Day 1||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2526076|NCT03716050|Secondary|Number of Participants Requiring Wound Care Management Modalities for Treatment of Delayed Wound Healing Complications||up to 30 days||||Participants|||Count of Participants
2526077|NCT03716050|Secondary|Number of Participants Requiring Outpatient Prescription for Antibiotics or Requiring Hospital Admission for IV Antibiotics||Up to 30 days||||Participants|||Count of Participants
2526078|NCT03716050|Secondary|Number of Participants With Operative Intervention Secondary to Perfusion Related Problems||Up to 30 days||||Participants|||Count of Participants
2526079|NCT03716050|Primary|Number of Participants With Delayed Wound Healing|manifesting as suture dehiscence and opening of an incisional wound|Up to 30 days||||Participants|||Count of Participants
2526080|NCT03716050|Primary|Number of Participants With Surgical Site Infection|Number of Participants with soft tissue cellulitis or abscess identified postoperatively either clinically or with wound culture|Up to 30 days||||Participants|||Count of Participants
2526081|NCT03716050|Primary|Number of Soft Tissue Ischemia/Loss|Number of partial and full thickness soft tissue defects identified postoperatively in clinic follow up|Up to 30 days|There were no participants randomized to group 6|||number of defects|||Number
2526082|NCT03715803|Other Pre-specified|Quality of Life: PISQ-12|"Quality of life assessed with Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire (PISQ-12) to evaluate sexual function in women with pelvic organ prolapse and/or urinary incontinence post-operative. Higher PISQ-12 scores indicate a better sexual function. Maximum score is 48."|Post-operative at 6 months||||score on a scale||Full Range|Median
2526083|NCT03715803|Other Pre-specified|Quality of Life: PFDI 20|"Quality of life assessed with Pelvic Floor Distress Inventory (PFDI 20) questionnaire to evaluate the impact of urinary, prolapse and colorectal distress post-operative. The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 (least distress) to 100 (greatest distress)."|Post-operative at 6 months||||score on a scale||Full Range|Median
2526084|NCT03715803|Secondary|Adverse Events|Register of adverse events. Clavien-Dindo classification|Intra-operative and post-operative at 6 months|Adverse events were presented in a separate section.||||||
2526085|NCT03715803|Secondary|Quality of Life Status: Patient Global Impression Questionnaire|"Patient satisfaction with the experience and the result of procedure will be evaluated with the Patient Global Impression questionnaire. This is a visual analogue scale range 1 (very much worse) - 5 (very much improved). A higher score a better outcome."|Post-operative at 6 months||||units on a scale||Full Range|Median
2526086|NCT03715803|Secondary|Percentage of Participants Cured According to Objective Measure (POP-Q Quantification)|Assessment of POP with POP-Q quantification. Number of participants cured according to POP-Q quantification. Success criteria: POP-Q stage equal 0 or 1.|Pre-operative and post-operative at 6 months||||percentage of cured patients|||Number
2526087|NCT03715803|Primary|Percentage of Cured Participants According to Barber Criteria|According to Barber criteria cure is defined if there are no points beyond the hymen (measure by POP-Q quantification), an absence of vaginal bulge symptoms and no re-treatment/interventions on year post procedure.|Post-operative at 6 months||||percentage of cured patients|||Number
2526088|NCT03715530|Primary|Number of Participants With PAMG-1 Test Results That Matched the Results of Gold Standard Testing|Number of participants with PAMG-1 test results that matched the results of gold standard testing|The assessment of the accurance PAMG-1 is completed by the end of the first study visit; one day.||||participants|||Number
2526089|NCT03715426|Other Pre-specified|4-Month Intimate Partner Violence Attitude Scale|Seventeen questions from the Intimate Partner Violence Attitude Scale - Revised will be used to assess for participant's attitudes related to intimate partner violence. Possible responses are on a Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree) with some items requiring reverse coding. Potential sum scores range from 17 to 85 with higher scores indicating a more favorable attitude towards intimate partner violence behaviors.|4-Months||||score on a scale||Standard Deviation|Mean
2526090|NCT03715426|Other Pre-specified|1-Month Intimate Partner Violence Attitude Scale|Seventeen questions from the Intimate Partner Violence Attitude Scale - Revised will be used to assess for participant's attitudes related to intimate partner violence. Possible responses are on a Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree) with some items requiring reverse coding. Potential sum scores range from 17 to 85 with higher scores indicating a more favorable attitude towards intimate partner violence behaviors.|1-Month||||score on a scale||Standard Deviation|Mean
2526091|NCT03715426|Other Pre-specified|4-Month Universal Violence Prevention Screening Protocol|Thirteen yes/no questions from the Universal Violence Prevention Screening Protocol will be used to assess for personal experiences of intimate partner violence with the last 4 months. Each item will be evaluated individually and no total score will be computed.|4-Month|"All of the Not Asked individuals (following the first question) were those who reported that they were not in a relationship in the past 4 months in the first question."|||Participants|||Count of Participants
2526092|NCT03715426|Other Pre-specified|1-Month Universal Violence Prevention Screening Protocol|Thirteen yes/no questions from the Universal Violence Prevention Screening Protocol will be used to assess for personal experiences of intimate partner violence with the last 1 month. Each item will be evaluated individually and no total score will be computed.|1-Month||||Participants|||Count of Participants
2526093|NCT03715426|Other Pre-specified|4-Month Consensual Sexual Activity With 2 Investigator Created Items|Two yes/no questions adopted from a colleague will be used to assess whether or not participants have ever engaged in sexual contact or intercourse that they found out was not consensual after the fact in the last 4 months. If they respond affirmatively then they will be asked an additional 14 descriptive questions about the event. Percent of students reporting ever engaging in sexual intercourse or contact that was not consensual will be reported.|4-Months||||Participants|||Count of Participants
2526094|NCT03715426|Other Pre-specified|1-Month Consensual Sexual Activity With 2 Investigator Created Items|Two yes/no questions adopted from a colleague will be used to assess whether or not participants have ever engaged in sexual contact or intercourse that they found out was not consensual after the fact in the last 1 month. If they respond affirmatively then they will be asked an additional 14 descriptive questions about the event. Percent of students reporting ever engaging in sexual intercourse or contact that was not consensual will be reported.|1-Month||||Participants|||Count of Participants
2526095|NCT03715426|Other Pre-specified|Self-Efficacy of Protective Behaviors Related to Sexual and Intimate Partner Violence as Assessed by 15 Investigator Created Items|Self-efficacy of protective behaviors related to sexual and intimate partner violence will be assessed using a questionnaire developed by the investigators. Participants will complete a 15 item questionnaire with responses ranging from 1 (not at all confident) to 7 (very confident) related to confidence in ability to handle situations related to sexual and intimate partner violence. The total score for each participant can range from 15 (not at all confident in any of the behaviors) to 105 (very confident in all behaviors).|4-Months|Data for the 4-Month Self-Efficacy scale were missing for 2 participants in the Intervention group.|||score on a scale||Standard Deviation|Mean
2526096|NCT03715426|Other Pre-specified|Self-Efficacy of Protective Behaviors Related to Sexual and Intimate Partner Violence as Assessed by 15 Investigator Created Items|Self-efficacy of protective behaviors related to sexual and intimate partner violence will be assessed using a questionnaire developed by the investigators. Participants will complete a 15 item questionnaire with responses ranging from 1 (not at all confident) to 7 (very confident) related to confidence in ability to handle situations related to sexual and intimate partner violence. The total score for each participant can range from 15 (not at all confident in any of the behaviors) to 105 (very confident in all behaviors).|1-Month|Data for the 1-Month Self-Efficacy scale were missing from 3 participants in the Intervention group and 5 participants in the Standard of Care group.|||score on a scale||Standard Deviation|Mean
2526097|NCT03715426|Other Pre-specified|4-Month Sexual and Intimate Partner Violence Knowledge Questions Assessed With 20 Items Adapted From the Texas Education Program Participant Response Form|Twenty knowledge questions about sexual and intimate partner violence adapted from the Texas Education Program Participant Response Form will be used to assess knowledge of healthy relationships, sexual violence, and intimate partner violence. The questions are scored from 1 (no knowledge) to 5 (a lot of knowledge) with higher scores indicating more knowledge. Possible sum scores range from 20 (no knowledge) to 100 (a lot of knowledge about all of the topics).|4-Months||||score on a scale||Standard Deviation|Mean
2526098|NCT03715426|Other Pre-specified|1-Month Sexual and Intimate Partner Violence Knowledge Questions Assessed With 20 Items Adapted From the Texas Education Program Participant Response Form|Twenty knowledge questions about sexual and intimate partner violence adapted from the Texas Education Program Participant Response Form will be used to assess knowledge of healthy relationships, sexual violence, and intimate partner violence. The questions are scored from 1 (no knowledge) to 5 (a lot of knowledge) with higher scores indicating more knowledge. Possible sum scores range from 20 (no knowledge) to 100 (a lot of knowledge about all of the topics).|1-Month|Data for the 1-Month Knowledge scale were missing from 1 participant in the Intervention group.|||score on a scale||Standard Deviation|Mean
2526099|NCT03715426|Other Pre-specified|4-Month Sexual Violence Perpetration as Assessed by the 10-item Sexual Experience Survey|The 10-item Sexual Experiences Survey will be used to measure participants' experiences of sexual violence perpetration. The revised Sexual Experiences Survey - Short Form Perpetration includes seven items that are used to assess the frequency of perpetration of sexual violence behaviors and three questions that explore the sex of the victims and if the individual believes they have perpetrated a rape. We will be using these to assess the number of times an individual has perpetrated sexual violence over the last 4 months from 0 to 3+ times. The results will be scored as a percentage of participants who have perpetrated each individual behavior and the percentage who believe they have perpetrated a rape.|4-Months||||Participants|||Count of Participants
2526111|NCT03714672|Secondary|Time to Intake of First Rescue Medication Dose|The time from first IMP dose to first dose of rescue medication (ibuprofen or ketorolac), if needed, within 24 hours post-dose was calculated.|First dose to 24 hours after first dose|Full Analysis Set|||hours||Standard Deviation|Mean
2526112|NCT03714672|Secondary|Time to Onset of Meaningful Pain Relief|Participants used a second stopwatch to document the time between first IMP dose and when they felt their pain relief was meaningful to them.|Up to 8 hours after first dose|Full Analysis Set|||hours||Standard Deviation|Mean
2526100|NCT03715426|Other Pre-specified|1-Month Sexual Violence Perpetration as Assessed by the 10-item Sexual Experience Survey|The 10-item Sexual Experiences Survey will be used to measure participants' experiences of sexual violence perpetration. The revised Sexual Experiences Survey - Short Form Perpetration includes seven items that are used to assess the frequency of perpetration of sexual violence behaviors and three questions that explore the sex of the victims and if the individual believes they have perpetrated a rape. We will be using these to assess the number of times an individual has perpetrated sexual violence over the last 1 month from 0 to 3+ times. The results will be scored as a percentage of participants who have perpetrated each individual behavior and the percentage who believe they have perpetrated a rape.|1-Month||||Participants|||Count of Participants
2526101|NCT03715426|Other Pre-specified|4-Months Sexual Victimization as Assessed by the 10-item Sexual Experience Survey|The 10-item Sexual Experiences Survey will be used to measure participants' experiences of sexual violence victimization. The revised Sexual Experiences Survey - Short Form Victimization includes 10 items that are used to assess the frequency of seven victimization behaviors and then uses three questions to explore the sex of the perpetrator and if the participant believes they were raped. We will be items 1-7 to assess the number of times an individual has experienced victimization over the last 5 months from 0 to 3+ times. The results will be scored as a percentage of participants who have experienced each individual behavior and the percentage who report that they have experienced a rape.|4-Months||||Participants|||Count of Participants
2526102|NCT03715426|Other Pre-specified|1-Month Sexual Victimization as Assessed by the 10-item Sexual Experiences Survey|The 10-item Sexual Experiences Survey will be used to measure participants' experiences of sexual violence victimization. The revised Sexual Experiences Survey - Short Form Victimization includes 10 items that are used to assess the frequency of seven victimization behaviors and then uses three questions to explore the sex of the perpetrator and if the participant believes they were raped. We will be items 1-7 to assess the number of times an individual has experienced victimization over the last 1 month from 0 to 3+ times. The results will be scored as a percentage of participants who have experienced each individual behavior and the percentage who report that they have experienced a rape.|1-Month||||Participants|||Count of Participants
2526103|NCT03715426|Secondary|4-Month Retention|The retention rate will be calculated based on how many participants in the intervention group have completed the follow-up surveys. A total retention rate (those retained/those enrolled) will be computed based on interaction with the WebApp.|4-Month|Retention was calculated based on the total number of participants that completed the Baseline survey.|||Participants|||Count of Participants
2526104|NCT03715426|Secondary|1-Month Retention|The retention rate will be calculated based on how many participants in the intervention group have completed the follow-up surveys. A total retention rate (those retained/those enrolled) will be computed based on interaction with the WebApp.|1-Month|Retention was calculated based on the total number of participants that completed the Baseline survey.|||Participants|||Count of Participants
2526105|NCT03715426|Primary|Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale|The 5-item System Acceptability Scale (investigator created) will be used to evaluate the acceptability of the WebApp in the intervention group only. An investigator-created acceptability scale with 5-items will be used to measure acceptability. Four items are scored from 1 (Strongly Agree/Very Likely) to 5 (Strongly Disagree/Very Unlikely) and will be reverse coded. One item assesses the frequency of use of the WebApp from 1 (Never) to 5 (Multiple times a week). All five items will be summed for a total score. Scores range from 5-25, with higher scores indicating greater acceptability.|4-Months|Only intervention participants were asked the items on the System Acceptability Scale.|||score on a scale||Standard Deviation|Mean
2526106|NCT03715426|Primary|Acceptability of the MKit WebApp as Assessed by the 5-item System Acceptability Scale|The 5-item System Acceptability Scale (investigator created) will be used to evaluate the acceptability of the WebApp in the intervention group only. An investigator-created acceptability scale with 5-items will be used to measure acceptability. Four items are scored from 1 (Strongly Agree/Very Likely) to 5 (Strongly Disagree/Very Unlikely) and will be reverse coded. One item assesses the frequency of use of the WebApp from 1 (Never) to 5 (Multiple times a week). All five items will be summed for a total score. Scores range from 5-25, with higher scores indicating greater acceptability.|1-Month|Only intervention participants were asked the items on the System Acceptability Scale.|||score on a scale||Standard Deviation|Mean
2526107|NCT03715426|Primary|Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale|Usability of the MKit WebApp will be measured using the 10-item System Usability Scale. Participants in the experimental group will complete the System Usability Scale, which is a 10 item questionnaire with responses that are rated from 1 (Strongly Disagree) to 5 (Strongly Agree) regarding use of the MKit WebApp. To get a final score: 1) First, one is subtracted from the score of the odd items; 2) Second, the responses are subtracted from 5 for the even-numbered items; 3) Then the responses are summed and multiplied by 2.5 to get a range of 0-100. A score above 68 is considered above average for perceived usability.|4-Months|Only intervention participants were asked the items on the System Usability Scale.|||score on a scale||Standard Deviation|Mean
2526108|NCT03715426|Primary|Usability of the MKit WebApp as Assessed by the 10-item System Usability Scale|Usability of the MKit WebApp will be measured using the 10-item System Usability Scale. Participants in the experimental group will complete the System Usability Scale, which is a 10 item questionnaire with responses that are rated from 1 (Strongly Disagree) to 5 (Strongly Agree) regarding use of the MKit WebApp. To get a final score: 1) First, one is subtracted from the score of the odd items; 2) Second, the responses are subtracted from 5 for the even-numbered items; 3) Then the responses are summed and multiplied by 2.5 to get a range of 0-100. A score above 68 is considered above average for perceived usability.|1-month|Only intervention participants were asked the items on the System Usability Scale.|||score on a scale||Standard Deviation|Mean
2526109|NCT03714672|Secondary|Incidence and Type of Adverse Events|The incidence of treatment emergent adverse events (TEAE) reported from first dose (Day 1) to last scheduled contact with the participant on Day 14 was descriptively summarized. Selected TEAEs were events with preferred terms of nausea, vomiting, abdominal pain, gastrointestinal bleeding, dizziness, or hypotension.|Day 1 to Day 14|Safety Set|||participants|||Number
2526113|NCT03714672|Secondary|Time to Onset of First Perceptible Pain Relief|Participants used one stopwatch to document the time between first IMP dose and when they begin to feel any pain-relieving effect from the IMP.|Up to 8 hours after first dose|Full Analysis Set|||hours||Standard Deviation|Mean
2526114|NCT03714672|Secondary|Time to Achieve a 50 Percent Reduction in Baseline Pain (Pain at Least Half Gone)|Time (hours) when the participant achieved a 50 percent reduction of baseline (starting) pain. It was assessed at defined time points after the first IMP dose using a YES or NO question for pain half gone.|Up to 24 hours after first dose|Full Analysis Set|||hours||Standard Deviation|Mean
2526115|NCT03714672|Secondary|Summed Pain Intensity Difference (SPID) at 4, 6, 8, and 24 Hours Post-dose|"Pain intensity was assessed by the participant before and at defined time points after the first IMP dose using an 11-point NRS with anchors at 0 for no pain and 10 for pain as bad as you can imagine. Pain Intensity Difference (PIDt) was defined as the difference between baseline pain intensity and pain intensity at time point t, and SPID defined as summed PIDt x [time (hours) elapsed since previous observation]. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum=10 at each time point], and negative numbers indicate an increase in pain [minimum=-10 at each time point]. The overall minimum and maximum are -10 and 10 times the number of hours specified (SPID-4=[-40 to 40], SPID-6=[-60 to 60], SPID-8=[-80 to 80], and SPID-24=[-240 to 240])."|Baseline; up to 24 hours after first dose|Full Analysis Set|||units on a scale||Standard Error|Least Squares Mean
2526116|NCT03714672|Secondary|Total Pain Relief at 8 Hours Post-dose (TOTPAR8)|Pain relief was assessed by the participant at defined time points after the first IMP dose using a 5-point VRS with categories 0 (none), 1 (a little), 2 (some), 3 (a lot), or 4 (complete). Total Pain Relief (TOTPAR8) is a time-weighted summary measure of the total area under the pain relief curve that integrates serial assessments of a participant's pain over the duration of 8 hours after IMP intake. Minimum and maximum values for TOTPAR8 were 0=worst score and 32=best score, a higher score indicates more pain relief.|Up to 8 hours after first dose|Full Analysis Set|||units on a scale||95% Confidence Interval|Least Squares Mean
2526117|NCT03714672|Secondary|Total Pain Relief at 6 Hours Post-dose (TOTPAR6)|Pain relief was assessed by the participant at defined time points after the first IMP dose using a 5-point VRS with categories 0 (none), 1 (a little), 2 (some), 3 (a lot), or 4 (complete). Total Pain Relief (TOTPAR6) is a time-weighted summary measure of the total area under the pain relief curve that integrates serial assessments of a participant's pain over the duration of 6 hours after IMP intake. Minimum and maximum values for TOTPAR6 were 0=worst score and 24=best score, a higher score indicates more pain relief.|Up to 6 hours after first dose|Full Analysis Set|||units on a scale||95% Confidence Interval|Least Squares Mean
2526118|NCT03714672|Primary|Pain Relief Expressed as Total Pain Relief (TOTPAR) Over the 4 Hours Post-dose Period (TOTPAR4)|Pain relief was assessed by the participant at defined time points after the first IMP dose using a 5-point verbal rating scale (VRS) with categories 0 (none), 1 (a little), 2 (some), 3 (a lot), or 4 (complete). Total Pain Relief (TOTPAR4) is a time-weighted summary measure of the total area under the pain relief curve that integrates serial assessments of a participant's pain over the duration of 4 hours after IMP intake. Minimum and maximum values for TOTPAR4 were 0=worst score and 16=best score, a higher score indicates more pain relief.|Up to 4 hours after first dose|Full Analysis Set|||units on a scale||95% Confidence Interval|Least Squares Mean
2526119|NCT03714659|Secondary|Change in Knee Injury and Osteoarthritis Outcome Score|A scale with five subdomains that aim to capture pain, symptoms, functional limitations, and effects on quality of life caused by (in this study) meniscal injury. Each subdomain is measured from 0 (complete impairment) to 100 (no impairment). A higher score indicates less pain or better function.|12 months.||||units on a scale||Standard Deviation|Mean
2526120|NCT03714659|Primary|Change in Numerical Pain Scale|Average knee pain between 0 (no pain) and 10 (maximum pain).|Baseline and 12 months.||||units on a scale||Standard Deviation|Mean
2526121|NCT03712917|Primary|Attack Frequencies|Number of headaches patients suffer in a month.|Post treatment 4 weeks||||headaches per month||Standard Deviation|Mean
2526122|NCT03712917|Primary|Visual Analog Scale|Range Pain 0-10, 0: No pain, 10: Worst Pain|Post treatment 4 weeks||||score on a scale||Standard Deviation|Mean
2526123|NCT03709810|Secondary|Mean Scores From Participant Completed Questionnaire|On each test day(Visit 2,3)participants underwent an OST exam,dentures cleaned using denture cleanser. Product application controlled by weight:1g(+/-0.1g)to upper denture,0.6g (+/-0.1g)to lower denture by dispensing staff. After 60+/-5min of replacing denture in the mouth, participants consumed 30-32g of non-salted peanuts, divided into smaller portions of app8nut halves. Each portion chewed for app20 sec. After eating all,participants answered a questionnaire for chewing experience by questions (Q):Q1,were you aware of nuts pieces under your denture:yes/no.Participants answered no to Q1 were not required to answerQ2,3;they were automatically assigned 0 score for Q2,3. Participants who answered yes to Q1 were asked Q2,3;Q2,rate amount of nuts pieces under your denture on0-10scale;Q3,how bothered were you by nuts pieces went under your denture on0-10scale.Q2score:0=none,10=lots of nuts pieces;Q3score:0=not at all bothered,10=extremely bothered. Lower scores indicate better results.|Upto 16 days|Efficacy analysis was performed on mITT population [N=48] included all randomized participants who received at least 1 dose of the study product and had at least 1 on-therapy assessment of efficacy.|||Score on scale||Standard Error|Mean
2526124|NCT03709810|Secondary|Number of Denture Dislodgements During Chewing as Reported by Participants|On each test day (Visit 2,3) participants had an OST exam and their dentures were cleaned before study product was applied to the dentures. 1g (+/-) was applied to the upper denture and 0.6g (+/-) was applied to the lower dentures by dispensing staff. After insertion of the dentures into participants mouths, they were required to wait 60 mins (+/- 5mins) after which they were required to chew 30-32g of non-salted peanuts, divided into smaller portions of approximately 8 nut halves. Participants were required to chew each portion of peanuts for approximately 20 secs. Whilst consuming the peanuts, participants were required to tick a box every time they felt their denture dislodge. The total number of dislodgments were recorded by study site staff.|Upto 16 days|Efficacy analysis was performed on mITT population [N=48] included all randomized participants who received at least 1 dose of the study product and had at least 1 on-therapy assessment of efficacy.|||Number of denture dislodgements||Full Range|Median
2526138|NCT03708744|Primary|Cmax|maximum observed plasma concentration|pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes, 2, 4, 8, 12, 24 hours post-dose||||pg/mL||Standard Deviation|Geometric Mean
2526496|NCT03673670|Secondary|Functional Residual Capacity on Day 3|Change in functional residual capacity during treatment|Change from pre-dose on Day 1 to the following timepoints: pre-dose, 1.25, 8.25 and 12.25 hours on Day 3 (after the morning dose)|Full analysis set|||Liters||Standard Deviation|Mean
2526125|NCT03709810|Secondary|Food Occlusion Analysis of Mass of Peanuts Under Mandibular Denture|On each test day (Visit2,3) participants underwent an OST exam, dentures cleaned using denture cleanser. Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After 60+/-5 min of replacing denture in the mouth, participants consumed 30-32g of non-salted peanuts, divided into smaller portions of app 8nut halves. Each portion was chewed for app20 sec. After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed, any nuts remaining in mouth were collected using gauze. Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min, water was strained by sieve. Collected nuts washed, air-dried and transferred to pre-weighed aluminium weighing pans, dried at 40-deg C for 5h. Pans removed, cooled to room temperature, weighed to determine mass of nuts collected from each denture.|Upto 16 days|Efficacy analysis was performed on mITT population [N=48] included all randomized participants who received at least 1 dose of the study product and had at least 1 on-therapy assessment of efficacy.|||mg||95% Confidence Interval|Geometric Mean
2526126|NCT03709810|Secondary|Food Occlusion Analysis of Mass of Peanuts Under Maxillary Denture|On each test day (Visit2,3) participants underwent an OST exam, dentures cleaned using denture cleanser. Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After 60+/-5 min of replacing denture in the mouth, participants consumed 30-32g of non-salted peanuts, divided into smaller portions of app 8nut halves. Each portion was chewed for app20 sec. After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed, any nuts remaining in mouth were collected using gauze. Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min, water was strained by sieve. Collected nuts washed, air-dried and transferred to pre-weighed aluminium weighing pans, dried at 40-deg C for 5h. Pans removed, cooled to room temperature, weighed to determine mass of nuts collected from each denture.|Upto 16 days|Efficacy analysis was performed on mITT population [N=48] included all randomized participants who received at least 1 dose of the study product and had at least 1 on-therapy assessment of efficacy.|||mg||95% Confidence Interval|Geometric Mean
2526127|NCT03709810|Primary|Food Occlusion Analysis of Combined Mass of Peanuts Under Combined Maxillary (Upper) and Mandibular (Lower) Dentures|On each test day(Visit2,3)participants underwent an Oral Soft Tissue (OST) exam,dentures cleaned using denture cleanser.Product application controlled by weight:1g(+/-0.1g)to upper denture ,0.6g (+/-0.1g)to lower denture by dispensing staff. After60+/-5minutes(min) of replacing denture in the mouth,participants consumed 30-32g of non-salted peanuts, divided into smaller portions of approximately(app) 8nut halves. Each portion was chewed for app20 seconds(sec). After which mouth rinsed with water for app10sec. Both upper and lower dentures were removed,any nuts remaining in mouth were collected using gauze.Dentures and gauzes placed in beaker with warm de-ionized water and sonicated for 30min,water was strained by sieve.Collected nuts washed,air-dried and transferred to pre-weighed aluminium weighing pans,dried at 40-degree Celsius (deg C)for 5 hours(h). Pans removed,cooled to room temperature,weighed to determine mass of nuts collected from each denture.|Upto 16 days|Efficacy analysis was performed on modified intent-to-treat (mITT) population [N=48] included all randomized participants who received at least 1 dose of the study product and had at least 1 on-therapy assessment of efficacy.|||Milligrams (mg)||95% Confidence Interval|Geometric Mean
2526128|NCT03708770|Secondary|Number of Endo-AVF-related Re-interventions|The re-intervention rate for endo-AVF (defined as any intervention required to maintain or re-establish patency) was calculated at each available follow-up visit post-index procedure.|At 6 months follow-up||||Participants|||Count of Participants
2526129|NCT03708770|Secondary|Number of Participants With Technical Success|Technical success is defined as verification that an endoAVF has been created and remains patent 1-7 days after the index procedure. Patency is determined by experienced examiner as the presence of a bruit that is detected with stethoscope, or presence of thrill, or via Duplex Ultrasound, or via angiogram.|1-7 days following index-procedure||||Participants|||Count of Participants
2526130|NCT03708770|Secondary|Number of Participants Per Catheter Exposure Type|Number of participants with Central Venous Catheters (CVC), endoAVF only access, CVC + endoAVF access, and not reciving dialysis at 3 and 6 months post-index procedure.|1-7 days, 30 days, 3, and 6 months post-index procedure|Number of participants (n) for each follow-up period varies from total participants in the study (N=32) according to the number of participants that attend follow-up and/or had data relevant to the analysis.|||Participants|||Count of Participants
2526131|NCT03708770|Secondary|Primary Patency at 6 Months Post-index Procedure|Primary Patency is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site to maintain or reestablish patency or loss of endoAVF patency. The primary patency rate is determined via Kaplan-Meier methods and based on the time of endoAVF creation until any intervention designed to maintain or reestablish patnecy or endoAVF abandonment.|6 months post-index procedure||||Percentage of participants|||Number
2526132|NCT03708770|Secondary|Percentage of Participants With Secondary Patency at 6 Months Post-Index Procedure|Time from endoAVF creation until access abandonment. Abandonment due to renal transplant receipt was not included in this endpoint assessment.|6 months post-index procedure||||Percentage of participants|||Number
2526133|NCT03708770|Secondary|Number of Days to Fistula Maturation|Defined as the number of days between the date of AVF creation and the date of endoAVF maturation (based on primary efficacy endpoint definition of maturation).|Days from Index Procedure||||Days from Index Procedure||Standard Deviation|Mean
2526134|NCT03708770|Primary|Number of Participants With Device-Related SAEs|The safety Endpoint is protocol-defined as Device-Related SAE at 3 months.|3 months following AVF creation||||Participants|||Count of Participants
2526135|NCT03708770|Primary|Number of Participants With Protocol-Defined endoAVF Maturation|Protocol-defined endoAVF maturation is defined as endoAVF that is free of stenosis or thrombosis, with brachial artery flow at least 500ml/min and at least 4 mm vein diameter (as measured by duplex ultrasound) OR subject was dialized using 2 needles.|Through 6 months post-index procedure||||Participants|||Count of Participants
2526136|NCT03708744|Secondary|t(1/2)|apparent half-life|pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes, 2, 4, 8, 12, 24 hours post-dose||||hours||Standard Deviation|Mean
2526137|NCT03708744|Secondary|Adverse Events|number of subjects that experienced at least one adverse event|24 hours|Subjects who received treatment|||Participants|||Number
2553722|NCT02770625|Secondary|Spleen Volume||from baseline to Week 24||||Milliliters||Standard Deviation|Mean
2526139|NCT03708562|Secondary|Percentage of Participants With Modified Primary Patency at 6 Months Post Index Procedure|Modified Primary Patency was defined as a measure of patency that, in addition to occlusion or reinterventions within the access circuit, also included coil embolization or open surgical ligation of outflow venous branches as failures of patency when they occur after the index procedure.|6 months post index procedure||||Percentage of participants|||Number
2526140|NCT03708562|Secondary|Number of Participants With EndoAVF Related Reintervention|The re-intervention rate for endoAVF (defined as any intervention required to maintain or re-establish patency) was calculated at each available follow-up visit post index procedure.|At 6 months follow-up||||Participants|||Count of Participants
2526141|NCT03708562|Secondary|Percentage of Participants With Functional Patency of the endoAVF at 6 Months Post Index Procedure|The interval of time from the first 2-needle dialysis utilizing the access until access abandonment (SVS Reporting Standards definition). Functional Patency was the interval of time from the first 2-needle dialysis of the endoAVF access circuit until access abandonment.|6 months post index procedure||||Percentage of participants||95% Confidence Interval|Number
2526142|NCT03708562|Secondary|Percentage of Participants With Secondary Patency at 6 Months Post Index Procedure|Secondary Patency was defined as the time interval between the endoAVF index procedure and a) access abandonment, or b) loss to thrombosis, irrespective of intervening surgical or endovascular interventions designed to re-establish functionality in a stenosed or thrombosed access circuit.|6 months post index procedure||||Percentage of participants|||Number
2526143|NCT03708562|Secondary|Percentage of Participants With Assisted Primary Patency at 6 Months|Defined as the interval from access placement to thrombosis or abandonment; not triggered by access circuit interventions performed in the absence of occlusion.|6 months post index procedure||||Percentage of Participants|||Number
2526144|NCT03708562|Secondary|Number of Participants With Cannulation Success at Defined Follow-up Intervals|"A subject was referred to as a 'cannulation success' with the first successful 2-needle cannulation of the endoAVF access circuit. Cannulation Success was defined by at least one successful hemodialysis session through a 2-needle cannulation of the endoAVF access circuit. Cumulative Cannulation Success = (Successes Through End Current Interval) / (Subjects on Dialysis at Start Current Interval + Censored Dialysis Subjects through End of Last Interval)."|0-10 days, 11-45 days, 46-135 days, 136-210 days post index procedure|Overall number of participants analyzed (n), and participants analyzed for each follow-up period varies from total participants in the study (N=24) according to the number of participants that attend follow-up and/or had data relevant to the analysis.|||Participants|||Count of Participants
2526145|NCT03708562|Secondary|Time to Cannulation (Months)|The interval of time from the index procedure to successful 2-needle cannulation of the endoAVF.|Months from index procedure to cannulation|Analysis population is lower than total subject number due to subject withdrawals before this endpoint could be analyzed.|||Months||Standard Deviation|Mean
2526146|NCT03708562|Secondary|Number of Participants With EndoAVF Maturation at 1, 3, and 6 Months Post Index Procedure|Maturity of the endoAVF was defined by duplex ultrasound criteria, as described in the literature as a useful surrogate of suitability for dialysis. Maturation was defined as duplex ultrasound flow in the brachial artery of at least 500 ml/min and a vein diameter ≥ 4mm, without significant stenosis or thrombosis. If a subject was on hemodialysis, maturity was defined by successful dialysis with 2-needles at least once.|1, 3, and 6 months post index procedure||||Participants|||Count of Participants
2526147|NCT03708562|Secondary|Percentage of Participants With Primary Patency at 6 Months Post Index Procedure|Primary Patency was defined as the time interval between the endoAVF index procedure and the earlier of a) any intervention designed to maintain or reestablish patency, b) access thrombosis, or c) access abandonment. Kaplan-Meier (KM) was used to analyze the data.|6 months post index procedure||||Percentage of participants|||Number
2526148|NCT03708562|Primary|Adverse Event Rate|Percentage of patients who experience one or more adverse events during the first 3 months following successful endoAVF creation. Adverse events were site-reported and reviewed by an independent Medical Monitor and the Clinical Events Committee (CEC).|3 months following endoAVF creation||||Participants|||Count of Participants
2526149|NCT03708562|Primary|Number of Participants With Procedural Success|Procedure Success was defined as successful endoAVF creation confirmed via intraprocedural angiography/fistulogram or duplex ultrasound verification performed post procedure.|At time of procedure||||Participants|||Count of Participants
2526150|NCT03707821|Secondary|Overall Quality of Vision Score|Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|2-Week Follow-up Evlauation|All subjects that completed the study without a major protocol deviation impacting a primary endpoint.|||Units on a Scale||Standard Deviation|Mean
2526151|NCT03707821|Secondary|Overall Handling Score|Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|2-Week Follow-up Evlauation|All subjects that completed the study without a major protocol deviation impacting a primary endpoint.|||Units on a Scale||Standard Deviation|Mean
2526162|NCT03706469|Secondary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)||Day 1 post dose up to 14 days after the last dose of study drug (Up to Day 47)|The safety analysis set included all participants who received at least one dose of the study drug(s).|||percentage of participants|||Number
2526163|NCT03706469|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-831||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The PK analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2573021|NCT02499692|Secondary|Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate||30 days||||percentage of participants|||Number
2526152|NCT03707821|Primary|Number of Grade 3 or Higher Slit Lamp Findings|Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). Slit Lamp Findings will be assessed for each subject eye at all study visits (schedule and unscheduled). SLF is a binary response where Y=1 for at least one Grade 3 or 4 slit lamp finding. The percentage of eyes with Grade 3 or higher slit lamp findings will be analyzed and will include corneal infiltrates. Eyes with multiple events will be counted only once. The number of eyes with SLF with grade 3 or higher by lens was reported.|Up to 2-Week Follow-up Evlauation|All subjects that were dispensed a study lens.|||Number of eyes|eyes||Number
2526153|NCT03707821|Primary|Contact Lens Fitting Acceptance Rate|"Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each subject eye. Fit acceptance rate will be based on the lens fit acceptance of eyes wearing the Test lens only. Fit acceptance is a binary response where Y=1 if lens fit is acceptable and Y=0 otherwise. Unacceptable is defined as unacceptable if any one of the following criteria:~limbal exposure at primary gaze or with extreme eye movement;~edge lift;~excessive movement in primary up gaze;~insufficient movement in all three of the following conditions: primary gaze, up gaze, and push up test.~Eyes with multiple unacceptable fitting events will be counted only once. Fit rates of the Control lens will also be collected but are not a primary endpoint."|Up to 2-Week Follow-up|All subjects that were dispsensed a study lens.|||Percentage of eyes|eyes||Number
2526154|NCT03707821|Primary|Distance Visual Acuity|Distance visual acuity was assessed by eye using LogMAR visual acuity at 4 meters using an ETDRS chart under high illumination high contrast conditions (room illumination > 400 lux and chart luminance 120-200 cd/m2) at the 2-week follow-up for each subject eye. Lower values of logMAR indicate better vision, where a score of 0.0 equates to 20/20 snellen vision. The average visual acuity for each lens was reported.|2-Week Follow-up Evlauation|Subjects that completed all study visits without a major protocol deviation impacting a primary endpoint.|||logMAR|eyes|Standard Deviation|Mean
2526155|NCT03707821|Primary|Vision Satisfaction in Bright Lighting|"Vision satisfaction in bright light was assessed using the individual item I was satisfied with the quality of my vision in bright lighting from the CLUE™ questionnaire. This item used the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. CLUE is the Contact Lens User Experience™ questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The Proportion of responses in each category were reported for each lens type."|2-Week Follow-up Evaluation|Subjects that completed all study visits without a major protocol deviation impacting a primary endpoint.|||Percentage of subjects|||Number
2526156|NCT03707821|Primary|Overall Comfort Score|Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|2-Week Follow-up Evlauation|All subjects that completed the study without a major protocol deviation impacting a primary endpoint.|||Units on a Scale||Standard Deviation|Mean
2526157|NCT03707522|Secondary|Positive Reframing; Brief COPE (B-COPE; Carver, 1997)|"28-item scale assessing various dimensions of healthy and unhealthy coping. This include 14 subscales: self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion, and self-blame. Each subscale consists of two items. Subscales are scored by summing items. Scale consists of 4-item Likert scale (1=I haven't been doing this at all to 4 I've been doing this a lot). Minimum score is 2, maximum score is 8 on each subscale. Higher scores indicate greater use of coping strategy. Positive reframing subscale was used."|3 months||||units on a scale||Standard Deviation|Mean
2526158|NCT03707522|Secondary|Substance Use Measure (Lee et al., 2015)|"3-item substance use measure including frequency of alcohol use, cigarette use and drug use. Items are measured using a five-point Likert scale (1=never or not at all to 5=almost always). The scale is scored by summing items. Minimum score is 3, maximum score is 15. Higher scores indicate more frequent substance use."|3 months|2 participants completed primary but not secondary outcomes|||units on a scale||Standard Deviation|Mean
2526159|NCT03707522|Secondary|Cognitive and Behavioral Avoidance Scale (CBAS, Ottenbreit & Dobson, 2003)|"The scale contains 31 items assessing cognitive avoidance and behavioral avoidance of social and non-social avoidance. The scale uses a 5-item Likert scale (1=Not at all true for me to 5=Extremely true for me). Total scale range from 0-155. The behavioral social factor contains 8 items. Items are summed. Minimum score is 8, maximum score is 40. The cognitive nonsocial scale contains 10 items. Minimum score is 10. Maximum score is 50. The cognitive social subscale consists of 7 items. Minimum score is 7, maximum score is 35. The behavioral nonsocial subscale consists of 6 items. Minimum score is 6, maximum score is 30. Higher scores indicate higher levels of avoidance."|3 months|1 participant completed primary but not secondary outcome measure|||units on a scale||Standard Deviation|Mean
2526160|NCT03707522|Primary|Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams & Lowe, 2006)|"7-item scale, common, brief measure of anxiety symptom severity. Items consist of a 4-point Likert scale (0=Not at all to 3=Nearly every day). Minimum score is 0, maximum score is 21. Higher scores indicate greater anxiety symptom severity."|3 months||||units on a scale||Standard Deviation|Mean
2526161|NCT03707522|Primary|Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer & Williams, 2001)|"9-item questionnaire associated containing one item for each symptom of MDD as specified by the DSM. Items consist of a 4-point Likert scale (0=Not at all to 3=Nearly every day). Minimum score is 0, maximum score is 27. Higher scores indicate greater depression severity."|3 months||||units on a scale||Standard Deviation|Mean
2526497|NCT03673670|Secondary|Functional Residual Capacity on Day 1|Change in functional residual capacity during treatment|Change from pre-dose to 1.25 hours on Day 1 (after the morning dose)|Full analysis set|||Liters||Standard Deviation|Mean
2526164|NCT03706469|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The PK analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration. The PK analysis population where data at specified time points were available.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2526165|NCT03706469|Primary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The pharmacokinetic (PK) analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration.|||nanogram*hour per milliliter(ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2526166|NCT03705481|Secondary|All Serious Adverse Events|Recording any SAE that occurred measured from the sheath insertion time through 48 hours post procedure or hospital discharge, whichever occurred first.|Measured from Sheath in time to discharge or 48 hours, whichever occurs first.|Number of participants with a Serious Adverse Events (SAEs) from the start of the Re- MOTE CorPath procedure until the end of the study|||Participants|||Count of Participants
2526167|NCT03705481|Secondary|Clinical Procedural Success|Number of patients with a residual stenosis (visual estimate, less than 30%) post PCI in the lesion(s) treated with the CorPath GRX POP System.|Measured from guide catheter in time through procedure end time (or guide catheter out time).|Number of participants with a residual stenosis less than 30% (visual estimate).|||Participants|||Count of Participants
2526168|NCT03705481|Primary|In-hospital MACE|Recording any MACE event that occurred from the time the sheath was inserted through 48 hours post procedure or hospital discharge, whichever of the two occurred first.|Measured from Sheath in time to discharge or 48 hours, whichever occurs first.|Number of participants with an In-hospital MACE occurrence.|||Participants|||Count of Participants
2526169|NCT03705481|Primary|Device Technical Success|Defined as completing the robotic PCI entirely with the CorPath GRX POP System.|Measured from guide catheter in time through procedure end time (or guide catheter out time).|Number of participants that had a remote robotic assisted PCI without unplanned conversion to manual technique.|||Participants|||Count of Participants
2526170|NCT03704376|Secondary|Narcotics Use as Assessed by Morphine Equivalents Consumed|morphine equivalents consumed during the entire post-anesthesia care unit (PACU) visit post surgery will be obtained from the All-scripts electronic medical record (EMR) system.|Entire post-anesthesia care unit (PACU) visit post surgery, PACU range 1 hr to 12 hrs post surgery||||milligrams (mg)||Standard Deviation|Mean
2526171|NCT03704376|Secondary|Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale|The items are scored on a visual analogical scale from 0-10, with 0 being the better|Postoperative physicians visit|||||||
2526172|NCT03704376|Secondary|Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale|The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.|12 hr post surgery|No participants were analyzed for this time point because participants were discharged from hospital at around 10 hours, before this time point would have occurred.||||||
2526173|NCT03704376|Secondary|Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale|The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.|11 hr post surgery|No participants were analyzed for this time point because participants were discharged from hospital at around 10 hours, before this time point would have occurred.||||||
2526174|NCT03704376|Secondary|Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale|The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.|10 hr post surgery||||units on a scale||Standard Deviation|Mean
2526175|NCT03704376|Secondary|Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale|The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.|9 hr post surgery||||units on a scale||Standard Deviation|Mean
2526176|NCT03704376|Secondary|Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale|The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.|8 hr post surgery||||units on a scale||Standard Deviation|Mean
2526177|NCT03704376|Secondary|Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale|The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.|7 hr post surgery||||units on a scale||Standard Deviation|Mean
2526178|NCT03704376|Secondary|Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale|The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.|6 hr post surgery||||units on a scale||Standard Deviation|Mean
2526179|NCT03704376|Secondary|Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale|The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.|5 hr post surgery||||units on a scale||Standard Deviation|Mean
2526180|NCT03704376|Secondary|Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale|The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.|4 hr post surgery||||units on a scale||Standard Deviation|Mean
2526181|NCT03704376|Secondary|Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale|The items are scored on a visual analogical scale from 0-10, with 0 being the better|3 hr post surgery||||units on a scale||Standard Deviation|Mean
2526182|NCT03704376|Secondary|Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale|The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.|2 hr post surgery||||units on a scale||Standard Deviation|Mean
2526183|NCT03704376|Secondary|Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale|The items are scored on a visual analogical scale from 0-10, 0 being the better outcome.|1 hr post surgery||||units on a scale||Standard Deviation|Mean
2526184|NCT03704376|Secondary|Straight Leg Raise Test|The straight leg raise assessment was performed in a standardized long-sitting position with well-knee flexed to 90 degrees. Patients were asked to complete 30 repetitions of straight leg raises with a small bolster supporting the heel using the following criteria; (1) perform with no visible quad lag (2) reach the height of the opposite tibial tubercle and (3) maintain a controlled rate of 30 hertz for the ascending and descending phases. The examination was only performed on the surgical limb and the absolute number of successful repetitions is reported.|4 weeks post operative||||number of repetitions||Standard Deviation|Mean
2526185|NCT03704376|Secondary|Straight Leg Raise Test|The straight leg raise assessment was performed in a standardized long-sitting position with well-knee flexed to 90 degrees. Patients were asked to complete 30 repetitions of straight leg raises with a small bolster supporting the heel using the following criteria; (1) perform with no visible quad lag (2) reach the height of the opposite tibial tubercle and (3) maintain a controlled rate of 30 hertz for the ascending and descending phases. The examination was only performed on the surgical limb and the absolute number of successful repetitions is reported.|Post-operative day 14||||number of repetitions||Standard Deviation|Mean
2526186|NCT03704376|Secondary|Straight Leg Raise Test|The straight leg raise assessment was performed in a standardized long-sitting position with well-knee flexed to 90 degrees. Patients were asked to complete 30 repetitions of straight leg raises with a small bolster supporting the heel using the following criteria; (1) perform with no visible quad lag (2) reach the height of the opposite tibial tubercle and (3) maintain a controlled rate of 30 hertz for the ascending and descending phases. The examination was only performed on the surgical limb and the absolute number of successful repetitions is reported.|Post-operative day 1||||number of repetitions||Standard Deviation|Mean
2526187|NCT03704376|Primary|Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)|Quadriceps muscle activation was examined using surface electromyography (sEMG) of the vastus medialis oblique muscle. Peak sEMG activity was recorded in microvolts (uV) on the surgical and contralateral limbs while performing five maximal effort isometric contractions in full knee extension--the reported values are equal to the quadriceps sEMG in uV of the contralateral limb minus the quadriceps sEMG in uV of the surgical limb.|4 weeks post operative||||microvolts (uV)||Standard Deviation|Mean
2526188|NCT03704376|Primary|Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)|Quadriceps muscle activation was examined using surface electromyography (sEMG) of the vastus medialis oblique muscle. Peak sEMG activity was recorded in microvolts (uV) on the surgical and contralateral limbs while performing five maximal effort isometric contractions in full knee extension--the reported values are equal to the quadriceps sEMG in uV of the contralateral limb minus the quadriceps sEMG in uV of the surgical limb.|Post-operative day 14||||microvolts (uV)||Standard Deviation|Mean
2526189|NCT03704376|Primary|Quadriceps Muscle Activation as Assessed by Surface Electromyography (sEMG)|Quadriceps muscle activation was examined using surface electromyography (sEMG) of the vastus medialis oblique muscle. Peak sEMG activity was recorded in microvolts (uV) on the surgical and contralateral limbs while performing five maximal effort isometric contractions in full knee extension--the reported values are equal to the quadriceps sEMG in uV of the contralateral limb minus the quadriceps sEMG in uV of the surgical limb.|Post-operative day 1||||microvolts (uV)||Standard Deviation|Mean
2526190|NCT03701061|Secondary|Number of Serious Adverse Events at Day 365 Among the Participants in Both Arms|"Serious adverse events are recorded from Day 1 post vaccination to Day 365 post vaccination. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, or is considered an other important medical event based on medical judgement."|Up to 365 days post vaccination||||number of events|||Number
2526191|NCT03701061|Secondary|Number of Unsolicited Adverse Events (AE's) Grade 2 and Above at Day 29 After Vaccination With the Seasonal Influenza Vaccine Among the Participants in Both Arms|To evaluate safety, grade 2 and above unsolicited AE's are recorded from Day 1 post vaccination to Day 29 post vaccination. Unsolicited AE information is volunteered or noted in an unsolicited manner and not as a required data element through a case report form.|Up to Day 29 post vaccination||||number of events|||Number
2526192|NCT03701061|Secondary|Number of Solicited (AE's) Grade 2 and Above at Day 8 After Vaccination With the Seasonal Influenza Vaccine Among the Participants in Both Arms|To evaluate safety, grade 2 and above solicited AE's are recorded from Day 1 post vaccination to Day 8 post vaccination.Solicited adverse events include local (pain, erythema and induration) and systemic (chills, loss of appetite, headache, fatigue, myalgia, arthralgia, nausea, fever (body temperature ≥ 38°C (100.4°F)).|up to Day 8 post vaccination||||number of events|||Number
2526193|NCT03701061|Primary|Number of Participants With a Four-fold Increase in Stem-specific Antibody Titers (H5, Hemagglutinin Antibody) Against H5N1 at Day 29 After Vaccination With the Seasonal Influenza Vaccine Among All the Participants in Both Arms|Antibody Titers (hemagglutinin inhibition antibody titers) are measured through immunologic assays from blood draw at Baseline (Day1) before study vaccination and are repeated on Day 29. Participants with four fold increase in titer levels will be recorded.|Baseline (Day 1) before vaccination and Day 29 post vaccination||||Participants|||Count of Participants
2526194|NCT03700671|Other Pre-specified|The Percentage of Individuals That Responsed to the Intervention|If participants had a postive increased in maximal oxygen consumption following the two interventions|8 weeks|A percentage of participants that increased maximal oxygen consumption|||Percentage|||Number
2526195|NCT03700671|Other Pre-specified|Intervention Fidelity - Participants That Complied With the Exercise Protocols|To assess if the interventions were delivered as intended, percentage of participants that complied with the exercise protocols|8 weeks|To assess the validity of the exercise interventions, participant fidelity to the desired exercise intensity was determined using cut points using specific cut points. Fidelity was measured over the course of the 16 sessions.|||Percentage||Inter-Quartile Range|Median
2526196|NCT03700671|Secondary|Oxygen Consumption at the Ventilatory Anaerobic Threshold|Oxygen consumption at the Ventilatory Anaerobic Threshold ml/kg/min. This measure will assess if individuals can exercise at higher intensities before lactate accumulation, thus becoming 'physiologically efficient|Baseline and 8 weeks||||ml/kg/min||Standard Deviation|Mean
2526197|NCT03700671|Primary|Maximal Oxygen Consumption (ml.Kg-1.Min-1)|Maximal oxygen consumption (ml.kg-1.min-1), as determined during a cardiopulmonary exercise test (CPET) represents the upper limit of aerobic fitness in humans. A low VO2max is associated with a greater risk of premature all-cause and cardiovascular mortality, independent of traditional risk factors and physical activity status. Conversely, increasing VO2max through exercise training may improve cardiometabolic health, quality of life and increase life-expectancy|Baseline and 8 weeks||||ml/kg/min||Standard Deviation|Mean
2526498|NCT03673670|Secondary|Residual Volume on Day 3|Change in residual volume during treatment|Change from pre-dose on Day 1 to the following timepoints: pre-dose, 1.25, 8.25 and 12.25 hours on Day 3 (after the morning dose)|Full analysis set|||Liters||Standard Deviation|Mean
2526198|NCT03698591|Other Pre-specified|Change in Self-reported Effort (Distraction) From Baseline to 30 Minutes Post Stimulation.|Effort is how difficult is was for a subject to use a specific emotion regulation technique. Subjects will be asked to rate how much effort they felt they used on a 7 point Likert scale ranging from 1 (very little effort) to 7 (very high effort) after using an emotion regulation technique (distraction) when shown graphic stimuli.|baseline, 30 minutes post stimulation|All subjects who completed the study protocol.|||score on a scale||Standard Deviation|Mean
2526199|NCT03698591|Other Pre-specified|Change in Self-reported Valence (Distraction) From Baseline to 30 Minutes Post Stimulation.|Valence is how positive or negative a subject feels. Subjects will be asked to rate how they feel on a 7 point Likert scale ranging from 1 (very negative) to 7 (very positive) after using an emotion regulation technique (distraction) when shown graphic stimuli.|baseline, 30 minutes post stimulation|All subjects who completed the study protocol.|||score on a scale||Standard Deviation|Mean
2526200|NCT03698591|Secondary|Change in Self-reported Effort (Distancing) From Baseline to 30 Minutes Post Stimulation.|Effort is how difficult it was for a subject to use a specific emotion regulation technique. Subjects will be asked to rate how much effort they felt they used on a 7 point Likert scale ranging from 1 (very little effort) to 7 (very high effort) after using an emotion regulation technique (distancing) when shown graphic stimuli.|baseline, 30 minutes post stimulation|All subjects who completed the study protocol.|||score on a scale||Standard Deviation|Mean
2526201|NCT03698591|Primary|Change in Self-reported Valence (Distancing) From Baseline to 30 Minutes Post Stimulation.|Valence is how positive or negative a subject feels. Subjects will be asked to rate how they feel on a 7 point Likert scale ranging from 1 (very negative) to 7 (very positive) after using an emotion regulation technique (distancing) when shown graphic stimuli.|baseline, 30 minutes post stimulation|All subjects who completed the study protocol.|||score on a scale||Standard Deviation|Mean
2526202|NCT03697083|Primary|Picking up Prescription on Intended Date of Pickup|"At the beginning of the study, participants indicate the date they plan to pick up their prescription. Participants are later asked to text a picture of their prescription receipt to the experimenter after they complete the prescription reminder program. The receipt must satisfy three criteria:~The receipt must show that a prescription was purchased.~The receipt must show the date of purchase. This date of purchase must match the participant's intended pick up date.~The participant must write the word End on their receipt. Upon receiving the picture text, one research assistant will verify that the image of the receipt satisfies all three criteria.~the investigators' primary dependent variable is binary taking the value one if the participant sends a picture of their receipt to the investigators that satisfies all criteria stated above and taking the value zero if otherwise."|The time frame can range from less than 1 day to a maximum of 7 days.||||percentage of prescriptions pickuped||Standard Deviation|Mean
2526203|NCT03695913|Secondary|Utility of CGM Feedback for Changing Diet|Utility of CGM feedback is expressed as the number of participants who qualitatively indicated that CGM feedback helped them to change their diet. Themes were identified and coded from qualitative interviews around this topic. Two qualitative coders identified themes that supported this construct.|60 days (30 days after visit 3 completion)||||Participants|||Count of Participants
2526204|NCT03695913|Secondary|Intention to Continue Low Carbohydrate Eating|"The completion survey asked participants a question, How confident are you that you can maintain a low carbohydrate diet for the next 12 months? Intention to Continue Low Carbohydrate eating used a scale of 1 to 5, where a score of 1 was not confident at all and a score of 5 was very confident."|day 22||||score on a scale||Standard Deviation|Mean
2526205|NCT03695913|Secondary|Change in Cravings From Day 11 to Day 22|Participants recorded cravings in food logs. Craving rating scale ranges from 1 to 5, where a score of 1 is low and a score of 5 is high.|11 days|10 participants submitted both pre- and post-intervention food logs. Data was unusable for 5 participants because they either did not complete the pre-intervention food log and/or they didn’t complete the post-intervention food log|||score on a scale||Standard Deviation|Mean
2526206|NCT03695913|Secondary|Change in Knowledge of Low Carbohydrate Eating|The Low Carbohydrate Knowledge Scale ranges from 15-41, where 15 is a low score and 41 is a high score. Participants were asked to report knowledge at baseline and completion. A positive score indicates an increase from baseline in knowledge, while a score of 15 indicates no change and a negative score indicates a decrease in knowledge from baseline.|baseline, day 22|One participant did not complete the baseline survey, so change could not be assessed.|||score on a scale||Standard Deviation|Mean
2526207|NCT03695913|Secondary|Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM in Patient Log|In the patient side effect log, participants recorded whether they experienced any side effects.|days 11 through 22||||Participants|||Count of Participants
2526208|NCT03695913|Secondary|Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM at Health Check Phone Call|During the health check phone call survey, participants were asked to report whether they experienced any side effects.|Approximately 5 days each new sensor is placed (days 5 and 16)||||Participants|||Count of Participants
2526209|NCT03695913|Secondary|Change in Percentage of Time Glucose is Above 140|Comparison between the first sensor wear period and the second sensor wear period.|33 days after day 1||||Percentage of Time Glucose is 140+||Standard Deviation|Mean
2526210|NCT03695913|Secondary|Weight Change|Change between visit 1 and the final visit.|day 11 (visit 2), day 22 (visit 3)||||pounds||Standard Deviation|Mean
2526211|NCT03695913|Secondary|Feasibility of Pre-diabetic Patients to Wear CGM Sensors|Feasibility is measured by the number of participants who wore a sensor for at least 20 out of 22 days|completed within 60 days of enrollment||||Participants|||Count of Participants
2526212|NCT03695913|Secondary|Feasibility, Measured by Recruitment|Successful recruitment completed within 3 months|3 months||||Participants|||Count of Participants
2526213|NCT03695913|Primary|Participant Satisfaction With Continuous Glucose Monitoring|Common qualitative themes related to participant satisfaction with CGM from post intervention interview were coded.|60 days (30 days after visit 3 completion)|2 participants did not participate in the qualitative interview.|||Participants|||Count of Participants
2526439|NCT03682809|Secondary|Corneal Staining|Improvement in conjuctivial staining at two weeks compared to baseline using the Brien Holden Vision Institute (BHVI) scale, which measures five regions of the eye on a (0-4) scale (max of 20 per metric). A score 0 is the best possible score.|Baseline through 2 Weeks||||Units on a scale||Standard Deviation|Mean
2526214|NCT03695913|Primary|Participant Satisfaction With Continuous Glucose Monitoring (CGM)|"Satisfaction is measured using responses to the post intervention survey question, How likely are you to recommend that a friend or family member with pre-diabetes wear a continuous glucose monitor (CGM)?. A 5 point scale was used, ranging from 1 to 5, where a score of 1 is extremely likely and 5 is would not recommend. Satisfied respondents answered either 1 or 2 on the scale."|33 days after day 1 (visit 3 completion)||||participants|||Number
2526215|NCT03694821|Secondary|Cost of Intervention|cost of each injection|3 months post injection|Data were collected, but the PI has left the institution. All efforts to locate and analyze the data have been exhausted; therefore no data are available to report.||||||
2526216|NCT03694821|Secondary|Non-routine Visits Due to Inadequate Pain Relief or Complications|Any additional visits due to inadequate pain relief or complications|3 months post injection|Data were collected, but the PI has left the institution. All efforts to locate and analyze the data have been exhausted; therefore no data are available to report.||||||
2526217|NCT03694821|Secondary|Patient Satisfaction|"satisfaction with treatment rated as Yes or No"|3 and 6 months post injection|Data were collected, but the PI has left the institution. All efforts to locate and analyze the data have been exhausted; therefore no data are available to report.||||||
2526218|NCT03694821|Secondary|Visual Analogue Pain Scale (VAS)|average knee pain between 0 (no pain) and 10 (worst pain) 6 months following injection|6 months|Data were collected, but the PI has left the institution. All efforts to locate and analyze the data have been exhausted; therefore no data are available to report.||||||
2526219|NCT03694821|Secondary|Koos, Jr. Knee Survey|self-reported pain, stiffness and functioning|3 and 6 months post injection|Data were collected, but the PI has left the institution. All efforts to locate and analyze the data have been exhausted; therefore no data are available to report.||||||
2526220|NCT03694821|Secondary|Oxford Knee Questionnaire|self-reported pain, stiffness and functioning|3 and 6 months post injection|Data were collected, but the PI has left the institution. All efforts to locate and analyze the data have been exhausted; therefore no data are available to report.||||||
2526221|NCT03694821|Secondary|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)|self-reported pain, stiffness and functioning|3 and 6 months post injection|Data were collected, but the PI has left the institution. All efforts to locate and analyze the data have been exhausted; therefore no data are available to report.||||||
2526222|NCT03694821|Primary|Visual Analogue Pain Scale (VAS)|average knee pain between 0 (no pain) and 10 (worst pain) 3 months following injection|3 months post injection|Data were collected, but the PI has left the institution. All efforts to locate and analyze the data have been exhausted; therefore no data are available to report.||||||
2526223|NCT03693989|Secondary|Symptomatology Post Instillation|"The subject will be questioned if after applying the medication he felt burning, pruritus, a foreign body sensation and blurred vision.~Presence or absence: it will be marked as present (1) or absent (0) for each of the symptoms questioned"|day 28 at the final visit|The analysis of the study was per protocol|||Participants|||Count of Participants
2526224|NCT03693989|Secondary|Intraocular Pressure|Tonometry is the objective measure of Intraocular pressure, based primarily on the force required to flatten the cornea, or the degree of corneal indentation produced by a fixed force. Goldman's tonometry is based on the Imbert-Fick principle. the result will be expressed in millimeters of mercury and the comparison between groups will be carried out|day 28 at the final visit|The analysis of the study was per protocol|||mmHg||Standard Deviation|Mean
2526225|NCT03693989|Secondary|Conjunctival Hyperemia|"Conjunctival hyperemia is defined as the simplest reaction of the conjunctiva to a stimulus, a red appearance secondary to the vasodilation of the conjunctival vessels of variable intensity, we will use the Efron scale for conjunctival hyperemia.~0 normal~very slight~mild~moderate~severe"|day 28 at the final visit|The analysis of the study was per protocol|||Participants|||Count of Participants
2526226|NCT03693989|Secondary|Central Thickness of the Retina|By means of optical coherence tomography (OCT) the Retinal central thickness (GCR) will be measured. OCT is a noninvasive imaging test that uses light waves to take photographs of the cross section of the retina (the light-sensitive tissue that lines the back of the eye).With a OCT, each of the characteristic layers of the retina can be observed, allowing mapping and measuring its thickness a micrometer result will be obtained and the analysis will be carried out between groups.|day 28 at the final visit|The analysis of the study was per protocol|||microns||Standard Error|Mean
2526227|NCT03693989|Secondary|Flare|"In the presence of intraocular inflammation, the increased permeability of the non-pigmented layer of the ciliary epithelium, the posterior epithelium of the iris and the vascular endothelium of the iris results in the accumulation of cells and proteins (visible to the examiner as flare) in the anterior chamber. Using a light beam of 0.2mm X 0.2mm directed obliquely to the anterior chamber with a forward inclination of the light source (slit lamp tower) the degree of flare and cellularity will be determined according to the group of work of standardization for the nomenclature of uveitis.~Flare scale~0 There is no flare~+ Mild~+ Moderate (iris and crystalline clearly visible)~+ Marking (iris and crystalline slightly blurred)~+ More than 60 (fibrin)"|day 28 at the final visit||||Participants|||Count of Participants
2526228|NCT03693989|Secondary|Clinical Corneal Edema|"The evaluation of clinical edema will be evaluated by the Efron scale, which is a series of factorial sections of the cornea, including features such as grooves and folds. The Efron scale has a strong correlation with variations in intensity. The number will be reported according to the rating awarded.~Efron Scale: 0 Normal, 1 very slight, 2 mild, 3 moderate and 4 severe."|day 28 at the final visit|The study analysis was comparative, it was only sought to determine if the difference between treatments is statistically significant or not.|||Participants|||Count of Participants
2526229|NCT03693989|Secondary|Cellularity in the Anterior Chamber|"unit: degrees, Direct observation (Biomicroscopy).~Scale for anterior chamber cellularity. Grade/Number of cells~Grade / Number of cells~0 Any~½ + 1-5~+ 6-15~+ 16-25~+ 26-60~+ More than 60~the cellularity will be measured according to the scale that is added next, considering as normal the degree 0, and abnormal any other degree."|day 28 at the final visit|The analysis of the study was per protocol|||Participants|||Count of Participants
2526230|NCT03693989|Primary|Adverse Events|"The evaluation of adverse events requires a questioning conducted by the principal investigator and the appropriate exploratory techniques for its detection.~the number of cases with adverse events will be reported per study arm"|day 28 at the final visit|The analysis of the study was per protocol|||cases|||Number
2526231|NCT03693989|Primary|Visual Ability (VA)|The VA will be evaluated basally, without refractive correction with the Snellen chart. Which will be located in a place with adequate lighting, natural or artificial and at a distance of 3 meters from the subject to be evaluated. The result of the Snellen fraction will be transformed to its decimal equivalent in LogMAR, ex. 20/20= 1.0, 20/25=0.8, 20/40= 0.5, 20/200= 1.0, etc. The subjects will be averaged by group.|day 28 at the final visit|the analysis was performed per protocol (PP)|||units on a scale (LogMAR)||Standard Deviation|Mean
2526232|NCT03693950|Secondary|CL|The total clearance|5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose||||ml/h||Inter-Quartile Range|Median
2526233|NCT03693950|Secondary|Kel|The elimination constant: kel=1/MRT, where MRT is median residence time: MRT=AUMC(0-72)/AUC(0-72)|5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose||||fraction of drug per hour||Inter-Quartile Range|Median
2526234|NCT03693950|Secondary|Tmax|The time to maximum drug concentration in the serum|5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose||||hours||Inter-Quartile Range|Median
2526235|NCT03693950|Secondary|AUC(0-∞)|The total area under the concentration curve from 0 to infinity|5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose||||pg/ml·h||Inter-Quartile Range|Median
2526236|NCT03693950|Secondary|T½|The elimination half-life|5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose||||hours||Inter-Quartile Range|Median
2526237|NCT03693950|Secondary|Cmax|The maximum concentration of darbepoetin alfa in the serum after the first and the fourth IV injection of BCD-066 or Aranesp®|5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose post-dose||||pg/ml||Inter-Quartile Range|Median
2526238|NCT03693950|Primary|AUC(0-72)|The area concentration curve for darbepoetin alfa from injection to 72 h (AUC(0-72) after the first and the fourth IV injection of BCD-066 or Aranesp|5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 h, 2 h, 4 h, 8 h, 16 h, 24 h, 48 h, 72 h post-dose||||pg/ml·h||Inter-Quartile Range|Median
2526239|NCT03693937|Primary|Cure Rate|NMSC cure rate will be calculated as the percentage of lesions that attained complete cure following SRT-100 treatment completion.|5 years||||lesions|lesions||Number
2526240|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|"Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed."||||||
2526241|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526242|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|"Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed."||||||
2526285|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526243|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526244|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|"Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed."||||||
2526245|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526246|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526247|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526248|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|"Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed."||||||
2573022|NCT02499692|Secondary|Target Vessel Failure (TVF) Rate||30 days||||percentage of participants|||Number
2526249|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526250|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|"Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed."||||||
2526251|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526252|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526253|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526254|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526255|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526256|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526257|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526258|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|"Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed."||||||
2526259|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526260|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526261|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526262|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526263|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526264|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526265|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526266|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|"Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed."||||||
2526267|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526268|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526269|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e. week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526270|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526271|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526272|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2573023|NCT02499692|Secondary|Target Vessel Revascularization (TVR) Rate||30 days||||percentage of participants|||Number
2526273|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526274|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|"Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed."||||||
2526275|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526276|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|"Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed."||||||
2526277|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526278|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|"Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed."||||||
2526440|NCT03682809|Secondary|End of Day Eye Comfort|Improvement in eye symptoms as measured with the Standardized Patient Evaluation of Eye Dryness (SPEED) at 2 weeks compared to baseline. The scale range is 0 to 28 with 0 being the best score.|Baseline through 2 Weeks||||score on a scale||Standard Deviation|Mean
2573024|NCT02499692|Secondary|Target Lesion Failure (TLF) Rate||30 days||||percentage of participants|||Number
2526279|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526280|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526281|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526282|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|"Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed."||||||
2526283|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526284|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|"Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed."||||||
2526499|NCT03673670|Secondary|Residual Volume on Day 1|Change in residual volume during treatment|Change from pre-dose to 1.25 hours on Day 1 (after the morning dose)|Full analysis set|||Liters||Standard Deviation|Mean
2526774|NCT03634306|Secondary|End-Tidal CO2 Level at Time 60|End-Tidal CO2 level recorded at 60 min during the operative procedure|Intraoperative||||Percent CO2||Standard Deviation|Mean
2526286|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526287|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526288|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526289|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526290|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526291|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526500|NCT03673670|Secondary|Determination of Onset of Action on Day 1|Time to >10% increase in FEV1 from pre-first dose, censored at 2 hours|Change from pre-dose to the following timepoints: 5, 15 and 30 minutes and 1, 1.5, 2 hours on Day 1 (after the morning dose)|Full analysis set|||minutes||Full Range|Median
2573025|NCT02499692|Secondary|Target Lesion Revascularization (TLR) Rate||30 days||||percentage of participants|||Number
2526292|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|"Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed."||||||
2526293|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526294|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526295|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526296|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526297|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526502|NCT03673670|Secondary|Change From Baseline in Peak FEV1 After Evening Dose on Day 3|Change from baseline FEV1 to peak FEV1 in the 4 hours post-dose after the evening dose on Day 3|Change from pre-dose to each of the ollowing timepoints: 5, 15 and 30 minutes and 1, 1.5, 2, 4 hours on Day 3 (after the evening dose), with the maximum change reported|Full analysis set|||Liters||Standard Deviation|Mean
2526298|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526299|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526300|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|"Analysis was to be performed on the enrolled subjects vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine, and who returned the ADR card, i.e.: only Fluarix Tetra Group subjects who received the second dose. As no AEs were reported for the MedDRA Class considered, the by risk status analysis could not be performed."||||||
2526301|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526302|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526303|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526503|NCT03673670|Secondary|Change From Baseline in Peak FEV1 on Day 1|Change from baseline FEV1 to peak FEV1 in the 4 hours post-dose after the morning dose on Day 1|Change from pre-dose to each of the following timepoints: 5, 15 and 30 minutes and 1, 1.5, 2, 4 hours on Day 1 (after the morning dose), with the maximum change reported|Full analysis set|||Liters||Standard Deviation|Mean
2526304|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526305|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526306|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526307|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Risk status (At risk; Not at risk) was recorded for influenza-associated morbidity and mortality as per healthcare professional assessment.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526308|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category|"The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°34 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526309|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category|"The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°32 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2540734|NCT03042559|Secondary|Iliotibial Band Flexibility|To assess the flexibility of iliotibial band|2 weeks||||degree||Standard Deviation|Mean
2526310|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category|"The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°30 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526311|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category|"The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°28 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526312|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category|"The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°26 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526313|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category|"The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°24 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526314|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category|"The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°22 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526423|NCT03685396|Primary|Post-operative Inability to Chew|"Inability to chew was described as the level of variation of the patients' eating habits due to the presence of the palatal wound.~The questionnaire included the evaluation of the intensity of post-operative inability to chew on a Visual Analogical Scale (VAS) of 100 mm. Patients had to show their level of inability to chew by indicating a position along a continuous line of 100mm between two end-points. The 0 end-point corresponded to abscence of changes in their eating habits whereas the end-point at 100mm corresponded to the worst possible inability to chew. Then the point indicated by the patient was measured in millimeters."|2 weeks||||score on a scale||Inter-Quartile Range|Median
2541461|NCT03023553|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization||||Participants|||Count of Participants
2526315|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category|"The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°20 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526316|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category|"The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°18 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526317|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category|"The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°16 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526318|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category|"The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°14 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526319|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category|"The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°12 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526424|NCT03685396|Primary|Post-operative Stress|Stress was related to the level of apprehension and fear experienced by the patients of jeopardizing the palatal wound. The questionnaire included the evaluation of the intensity of post-operative stress on a Visual Analogical Scale (VAS) of 100 mm. Patients had to show their level of stress by indicating a position along a continuous line of 100mm between two end-points. The 0 end-point corresponded to abscence of stress whereas the end-point at 100mm corresponded to the worst possible stress . Then the point indicated by the patient was measured in millimeters.|2 weeks||||score on a scale||Inter-Quartile Range|Median
2526775|NCT03634306|Secondary|End-Tidal CO2 Level at Time 45|End-Tidal CO2 level recorded at 45 min during the operative procedure|Intraoperative||||Percent CO2||Standard Deviation|Mean
2526320|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category|"The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°10 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526321|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category|"The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°8 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526322|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category|"The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°6 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526323|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category|"The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°4 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526324|NCT03688620|Secondary|Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category|"The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°2 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526425|NCT03685396|Primary|Post-operative Discomfort|Discomfort was defined as the level of soreness experienced by the patients during the first post-operative week due to the palatal wound and how it influenced the ability to work and the quality of the sleep. The questionnaire included the evaluation of the intensity of post-operative discomfort on a Visual Analogical Scale (VAS) of 100 mm. Patients had to show their level of discomfort by indicating a position along a continuous line of 100mm between two end-points. The 0 end-point corresponded to abscence of discomfort whereas the end-point at 100mm corresponded to the worst possible discomfort . Then the point indicated by the patient was measured in millimeters.|2 weeks||||score on a scale||Inter-Quartile Range|Median
2526776|NCT03634306|Secondary|End-Tidal CO2 Level at Time 30|End-Tidal CO2 level recorded at 30 min during the operative procedure|Intraoperative||||Percent CO2||Standard Deviation|Mean
2526325|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category|"The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°68 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526326|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category|"The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°66 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526327|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category|"The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°64 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526328|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category|"The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°62 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526329|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category|"The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°60 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526352|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for cardiac disorders.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526330|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category|"The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°58 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526331|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category|"The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°56 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526332|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category|"The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°54 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526333|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category|"The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°52 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526334|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category|"The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°50 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526353|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for cardiac disorders.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526335|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category|"The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°48 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526336|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category|"The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°46 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526337|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category|"The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°44 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526338|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category|"The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°42 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526339|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category|"The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°40 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||percentage of subjects||95% Confidence Interval|Number
2526378|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for investigations.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526340|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category|"The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°38 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526341|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category|"The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. Age strata were defined as 6 months to 17 years, 18 to 65 years and >65 years. All subjects who received the second dose of vaccine, were in the first age stratum: 6 months to 17 years. Please, refer to outcome n°36 for the overall (across age strata) post-dose 2 results."|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526342|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for vascular disorders.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526343|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for vascular disorders.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526344|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52.There were no predefined AEIs listed on the ADR card for investigations.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526345|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for investigations.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526412|NCT03687736|Secondary|Subject Self-Assessment Using a 4-point Categorical Scale|Evaluate efficacy using a subject self-assessment scale that measures the severity of glabellar lines at maximum frown|Months 1,3,6,7,9 and 12|Intent to Treat Population (all subjects treated with study product) attending visit.|||Participants|||Count of Participants
2526346|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526347|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526348|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for eye disorders.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526349|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for eye disorders.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526350|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526351|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526413|NCT03687736|Secondary|Evaluate the Impact of Treatment; Psychological Function|FACE-Q Psychological Function. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome.|Months 1,3,6,7,9 and 12|Intent to Treat Population (all subjects treated with study product) attending visit.|||score on a scale||Standard Deviation|Mean
2526354|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were rash and rash generalised.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526355|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were rash and rash generalised.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526356|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526357|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526358|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEI listed on the ADR card was irritability.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526359|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEI listed on the ADR card was irritability.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526414|NCT03687736|Secondary|Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows|FACE-Q Appraisal of Lines: Between Eyebrows. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome.|Months 1,3,6,7,9 and 12|Intent to Treat Population (all subjects treated with study product) attending visit.|||score on a scale||Standard Deviation|Mean
2526360|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526361|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526362|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526363|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526364|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEI listed on the ADR card was decreased appetite.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526365|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEI listed on the ADR card was decreased appetite.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526415|NCT03687736|Secondary|Subject Satisfaction With Aesthetic Outcome in Treated Area|based on Subject Satisfaction questionnaire data|Months 1,3,6,7,9 and 12|Intent to Treat population (all subjects treated with study product). Number analyzed = Number of subjects completing Subject Satisfaction questionnaire at each visit following treatment.|||Participants|||Count of Participants
2526777|NCT03634306|Secondary|End-Tidal CO2 Level at Time 15|End-Tidal CO2 level recorded at 15 min during the operative procedure|Intraoperative||||Percent CO2||Standard Deviation|Mean
2526366|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526367|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526368|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were anaphylactic reaction and hypersensitivity.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526369|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were anaphylactic reaction and hypersensitivity.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526370|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526371|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526416|NCT03687736|Primary|Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines|Percentage of subjects satisfied with the treatment results assessed by satisfaction question at Month 12 visit.|12 months|Modified Intent to Treat Population (all subjects treated with study product both at Baseline and Month 6) attending Month 12 visit.|||Participants|||Count of Participants
2526372|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526373|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526374|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526375|NCT03688620|Primary|Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall|The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between Intenational Organization for Standardization (ISO) weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526376|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for vascular disorders.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526377|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for vascular disorders.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526417|NCT03685968|Other Pre-specified|Final Intubation Time for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL|Total time for placing the endotracheal tube (ETT) through the vocal cords|During laryngoscopy and endotracheal tube placement|"Group A: 3 participants excluded due to protocol deviations. Group B: 8 participants excluded due to protocol deviations, 2 participant had failed intubation, 4 participants had device failure.~Group C: 2 participants excluded due to protocol deviations, 1 participant had device failure."|||seconds||Standard Deviation|Mean
2526778|NCT03634306|Secondary|End-Tidal CO2 Level at Time 0|End-Tidal CO2 leve; recorded at 0 min during the operative procedure|Intraoperative||||Percent CO2||Standard Deviation|Mean
2526379|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for investigations.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526380|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526381|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526382|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for eye disorders.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526383|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for eye disorders.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526384|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526418|NCT03685968|Secondary|First-attempt Successful Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL|The overall first-attempt success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL|During laryngoscopy and endotracheal tube placement||||Participants|||Count of Participants
2526419|NCT03685968|Primary|Overall Successful Tracheal Intubation for All 3 Video Laryngoscopes - GSAVL, KVChVL and KVNChVL|The overall intubation success rates for all 3 video laryngoscopes - GSAVL, KVChVL and KVNChVL|During laryngoscopy and endotracheal tube placement||||Participants|||Count of Participants
2526779|NCT03634306|Secondary|Temperature at Time 60 Min|Temperature in degrees Celsius at 60 min during operative procedure|Intraoperative||||Degrees Celsius||Standard Deviation|Mean
2526385|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526386|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for cardiac disorders.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526387|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for cardiac disorders.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526388|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were rash and rash generalised.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526389|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were rash and rash generalised.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526390|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526420|NCT03685643|Secondary|Depression Symptoms Will be Measured by the Patient Health Questionnaire-2 (PHQ-2).|"Participants' risk of depression will be measured by the Patient Health Questionnaire-2 (PHQ-2). This is a 2 item scale (with a 4 level Likert scale ranging from Not at all to Nearly everyday) and the score ranges from 0-6, with a higher score indicating higher risk of depression."|8 month||||Score on a scale||Standard Deviation|Mean
2526421|NCT03685643|Secondary|Risk Taking Tendencies Will be Measured by the The Risk Propensity Scale.|"Participants' risk taking tendencies will be measured by the The Risk Propensity Scale. It is a 9-item scale measuring general risk-taking tendencies. Each item is rated on a 9 level Likert scale (ranging from totally disagree to totally agree) with the final score ranging from 1-9. A higher score indicates higher risk-taking tendencies."|8 month||||Score on a scale||Standard Deviation|Mean
2526391|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526392|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEI listed on the ADR card was irritability.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526393|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEI listed on the ADR card was irritability.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526394|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526395|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526396|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526422|NCT03685643|Primary|Self Efficacy: This Will be Measured by the General Self Efficacy Scale|"The primary outcome will be the self-efficacy on the safe usage of dating. applications among young adults in Hong Kong. This will be measured by the General Self Efficacy Scale. The General Self Efficacy Scale is a 10-item scale (with 4 level Likert scale ranging from not true at all to exactly true) measuring one's self-belief in completing certain tasks or overcoming difficulties. The total score is calculated by finding the sum of all items with the total score ranging between 10 and 40, with a higher score indicating a higher level of self efficacy."|8 months||||Score on a scale||Standard Deviation|Mean
2526780|NCT03634306|Secondary|Temperature at Time 45 Min|Temperature in degrees Celsius at 45 min during operative procedure|Intraoperative||||Degrees Celsius||Standard Deviation|Mean
2526397|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526398|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card was decreased appetite.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526399|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card was decreased appetite.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526400|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526401|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526402|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526403|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were anaphylactic reaction and hypersensitivity.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526404|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526405|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526406|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526407|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526408|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 46 and 52.|Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with a second dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card. This analysis was performed only for the Fluarix Tetra Group, and not on the other groups who did not received this second dose.|||Percentage of subjects||95% Confidence Interval|Number
2526409|NCT03688620|Secondary|Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall|The weekly percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination at the same week. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards.|Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days|Analysis was performed on the enrolled subjects who were vaccinated with the first dose of GSK’s quadrivalent seasonal influenza vaccine and who returned the ADR card.|||Percentage of subjects||95% Confidence Interval|Number
2526410|NCT03687736|Secondary|Onset of Treatment Response|Subject perception of treatment response|After treatment at Baseline and Month 6, assessed up to 1 week after each treatment visit|Intent to Treat Population (all subjects treated with study product) who returned diary cards.|||days||Standard Error|Mean
2526411|NCT03687736|Secondary|Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity|Evaluate efficacy at visits using a 4-point photographic scale of glabellar line severity, by Investigator Live assessment at maximum frown.|Months 1,3,6,7,9 and 12|Intent to Treat Population (all subjects treated with study product) attending visit.|||Participants|||Count of Participants
2526781|NCT03634306|Secondary|Temperature at Time 30 Min|Temperature in degrees Celsius at 30 min during operative procedure|Intraoperative||||Degrees Celsius||Standard Deviation|Mean
2526426|NCT03685396|Primary|Post-operative Pain: VAS|The patient morbidity was evaluated with a questionnaire given to patients 1 week following surgery considering parameters such as post-operative pain, discomfort, bleeding, stress and inability to chew. The questionnaire included the evaluation of the intensity of these parameters on a Visual Analogical Scale (VAS) of 100 mm. Patients had to show their level of pain by indicating a position along a continuous line of 100mm between two end-points. The 0 end-point corresponded to abscence of pain, whereas the end-point at 100mm corresponded to the worst level of pain felt in life. Then the point indicated by the patient was measured in millimeters.|2 weeks.||||score on a scale||Inter-Quartile Range|Median
2526427|NCT03684265|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).~Standard error is actually Geometric standard error."|Baseline (pre-dose), 0.5 hours(h), 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 10.0h, 12.0h, 24.0h, 32.0h, 48.0h and 72.0h post-dose|PKS|||ng·h/mL||Standard Error|Geometric Least Squares Mean
2526428|NCT03684265|Primary|Maximum Measured Concentration of the Analyte in Plasma (Cmax)|"Maximum measured concentration of the analyte in plasma (Cmax).~Standard error is actually Geometric standard error."|Baseline (pre-dose), 0.5 hours(h), 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 10.0h, 12.0h, 24.0h, 32.0h, 48.0h and 72.0h post-dose|PKS|||ng/mL||Standard Error|Geometric Least Squares Mean
2526429|NCT03684265|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-t)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-t).~Standard error is actually Geometric standard error."|Baseline (pre-dose), 0.5 hours (h), 1.0h, 2.0h, 3.0h, 4.0h, 5.0h, 6.0h, 7.0h, 8.0h, 10.0h, 12.0h, 24.0h, 32.0h, 48.0h and 72.0h post-dose|Pharmacokinetic set (PKS): This set includes all randomised subjects who met the protocol requirements without important protocol deviation and completed all study periods.|||Nanogram (ng)·hour (h)/ mililiter(mL)||Standard Error|Geometric Least Squares Mean
2526430|NCT03683901|Primary|Passive Range of Motion of Shoulder in Shoulder Abduction|passive range of motion of shoulder in shoulder abduction as measured with hand-held goniometer|10 seconds|Cross-over design. All participants underwent all interventions|||degrees||95% Confidence Interval|Mean
2526431|NCT03683901|Primary|Passive Range of Motion of Shoulder in Shoulder External Rotation|passive range of motion of shoulder in shoulder external rotation as measured with hand-held goniometer|10 seconds|Cross-over design. All participants underwent all interventions|||degrees||95% Confidence Interval|Mean
2526432|NCT03683758|Other Pre-specified|Player Information|"Month and year of birth, height, weight and player position, number of years playing soccer, injury status, approximate number of hours of moderate/high intensity exercise per week (including soccer), and pregnancy status will be collected from each player.~This information will be collected to compare and contrast the averages of these variables once participants are assigned to the control or intervention group."|5 minutes before pre-testing.|||||||
2526433|NCT03683758|Secondary|Warm-up Attendance|Practice and game attendance will be recorded so warm-up compliance may be calculated. This will be done three days per week for eight weeks.|8 weeks|Three players from each team were not included in the analysis due to breach of inclusion criteria (i.e. injury, illness and/or missing a testing session)|||Percentage of warm-ups attended||Standard Deviation|Mean
2526434|NCT03683758|Primary|Percentage Change From Baseline in Squat Jump Height After an 8 Week Intervention|"Squat jumps will be measured in centimeters.~This test requires each participant to stand on a contact mat with their hands on their hips, squat and pause in a position with their knees at a 90 degree angle, then propel upward as high as possible.~Three trials will be performed during the pre-test and the posttest, with the best time being selected for each. Participants will have a 1-minute break between trials."|Intervention is 8 weeks in duration with baseline and post-test outcome measurements occurring within 3 days of the commencement and end of the intervention period|Three players from each team were not included in the analysis due to breach of inclusion criteria (i.e. injury, illness and/or missing a testing session)|||Percentage of change||Standard Deviation|Mean
2526435|NCT03683758|Primary|Percentage Change From Baseline in Agility T-Test Times After an 8 Week Intervention|"Agility T-test times will be recorded in seconds..~The Agility T-Test involves a stationary participant running forward through a timing gate to touch a cone 10 yards away, shuffle 5 yards to the left to touch a second cone, shuffle right 10 yards to touch a third cone, shuffle left to touch a fourth cone (the first cone touched after the 10 yard run), then back-peddle 10 yards to pass through the timing gate a second time. This running pattern creates a T shape with the vertical and horizontal components of the T measuring 10 yards each.~Three trials will be performed during the pre-test and the posttest, with the best time being selected for each. Participants will have a 2-minute break between trials."|Intervention is 8 weeks in duration with baseline and post-test outcome measurements occurring within 3 days of the commencement and end of the intervention period.|Three players from each team were not included in the analysis due to breach of inclusion criteria (i.e. injury, illness and/or missing a testing session)|||Percentage of change||Standard Deviation|Mean
2526436|NCT03683758|Primary|Percentage Change From Baseline in 10m Sprint Times After an 8 Week Intervention|"10m sprint times will be recorded in seconds.~The 10m sprint involves a stationary participant starting behind a timing gate and running through a second timing gate 10 meters away.~Three trials will be performed during the pre-test and the posttest, with the best time being selected for each. Participants will have a 2-minute break between trials."|Intervention is 8 weeks in duration with baseline and post-test outcome measurements occurring within 3 days of the commencement and end of the intervention period|Three players from each team were not included in the analysis due to breach of inclusion criteria (i.e. injury, illness and/or missing a testing session)|||Percentage of change||Standard Deviation|Mean
2526437|NCT03682809|Secondary|Tear Break-Up Time (TBUT)|Improvement in tear break up time as measured with a slit-lamp biomicroscope and sodium fluorescein in seconds at 2 weeks compared to baseline. Scores range for 0 to 60 seconds with 60 seconds being the best score.|Baseline through 2 Weeks||||Seconds||Standard Deviation|Mean
2526438|NCT03682809|Secondary|Schirmer's I Test Without Anesthetic|Improvement in tear volume as measured in mm of wetting with a Schirmer's strip at 5 mins at 2 weeks compared to baseline. The score ranges is 0 mm to 35 mm with 35 mm being the best score.|Baseline through 2 Weeks||||mm||Standard Deviation|Mean
2526441|NCT03682809|Primary|Contact Lens Symptoms|Improvement in contact lens symptoms as measured with the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) and CLDEQ-4 at 2 weeks compared to baseline. The CLDEQ-8 score range is 0 to 37 with 0 being the best score. Subjects were required to have a CLDEQ-8 of at least 12 in order to participate. The CLDEQ-4 is a subset of the CLDEQ-8, and it was also reported because it is a unidimensional measure of ocular discomfort in contact lens wearers. The CLDEQ-4 has a score range of 0 to 18 with 0 being the best score.|Baseline through 2 Weeks||||Score on a Scale||Standard Deviation|Mean
2526442|NCT03680105|Primary|Safety and Tolerability of RJX as Assessed by Neurological Examinations.|Number of participants with clinically significant values and actual changes from baseline of continuous neurological assessments.|Up to Day 5 for Part 1 and Up to Day 12 for Part 2|Analysis based on Intent to Treat (ITT) population across Part 1 and Part 2, all cohorts. Only 1 subject, one incidence, for the study; presented on Day 12, Principal Investigator considered clinically significant and a mild TEAE considered unlikely related to RJX.|||Participants|||Count of Participants
2526443|NCT03680105|Primary|Safety and Tolerability of RJX as Assessed by Electrocardiograms (ECGs).|Number of participants with abnormal and clinically significant findings based on ECG.|Up to Day 2 for Part 1 and Up to Day 8 for Part 2|Counts of 12-lead safety ECG interpretations across Intent to Treat (ITT) population showed no notable changes when compared to baseline for either study part.|||Participants|||Count of Participants
2526444|NCT03680105|Primary|Treatment-related Adverse Events (TEAE) Reporting of RJX|Number of participants with indicated AEs receiving RJX as assessed by CTCAE v4 03|Up to Day 5 for Part 1 and Up to Day 12 for Part 2||||Participants|||Count of Participants
2526445|NCT03679741|Secondary|Overall Quality of Vision Indoors|"Overall Quality of Vision Indoors was assessed using the individual item Overall Quality of Vision Indoors from questionnaire assessing contact lens performance. This item used the response scale, 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. The Proportion of responses in each category were reported for each lens type."|2-Week Follow-up|subjects that completed all study visits without a major protocol deviation.|||Proportion of participants|||Number
2526446|NCT03679741|Secondary|Overall Handling Scores|Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|2-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Units on a Scale||Standard Deviation|Mean
2526447|NCT03679741|Secondary|Overall Quality of Vision Score|Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|2-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Units on a Scale||Standard Deviation|Mean
2526448|NCT03679741|Primary|Number of Grade 3 or Higher Slit Lamp Findings|Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher by lens was reported.|Up to 2-Week Follow-up|All subjects dispensed a study lens.|||proportion of eyes|eyes||Number
2526449|NCT03679741|Primary|Contact Lens Fitting Acceptance Rate|Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at all study visits. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The percentage of eyes with acceptable lens fit was reported for each lens.|Up to 2-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||percentage of eyes|eyes||Number
2526450|NCT03679741|Primary|Distance Monocular LogMAR Visual Acuity|Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart under high illumination low contrast (room illumination > 400 lux and chart luminance 120-200 cd/m2) and low illumination high contrast (room illumination <2.5 lux and chart luminance 2.0 - 5.0 cd/m2 at the 2-week follow-up for each subject eye. The average visual acuity for each lens was reported.|2-Week Follow-up|subjects that completed all study visits without a major protocol deviation.|||logMAR|Eyes|Standard Deviation|Mean
2526451|NCT03679741|Primary|Vision Satisfaction in Bright Lighting|"Vision satisfaction in bright light was assessed using the individual item I was satisfied with the quality of my vision in bright lighting from the CLUE™ questionnaire. This item used the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. CLUE is the Contact Lens User Experience™ questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The Proportion of responses in each category were reported for each lens type."|2-Week Follow-up|subjects that completed all study visits without a major protocol deviation.|||Proportion of participants|||Number
2526452|NCT03679741|Primary|Overall Comfort Score|Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|2-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Units on a Scale||Standard Deviation|Mean
2526453|NCT03679494|Secondary|Assess the Quality of Healthy Living About Patients|Use the EQ-5D-5L scale to measure patients' quality of healthy living. It has 5 items (Mobility, Self-care, Usual activities, Pain/discomfort, Depression/anxiety). Each item contains 5 levels: 1= no difficulty, 2= slight difficulty, 3= moderate difficulty, 4= serious difficulty, 5= extremely serious difficulty. The higher the score has the worse the health. Then, the score calculation of the European Five-Dimensional Health Scale is based on the calculation formula published by the EuroQol Group. Based on 5 combinations of different severity levels, a score of 0 to 1 is obtained. 0 is the least healthy and 1 is the most healthy.|Before intervention, up to 12 weeks after intervention|Patients lost up to 12 weeks after intervention.|||score on a scale||Standard Deviation|Mean
2526454|NCT03679494|Secondary|Assess the Degree of Disability of Lower Back Pain|Use the Oswestry Disability Index to measure lower back pain patients' degree of disability. It has 10 items (Pain, self-care, bring, walking, sitting, standing, sleeping, sex, social, travelling). After adding up the total score of each item, the initial total score is 0 to 50 points. Then divide the total score by 5 and multiply by 20 to get the final score of 0 to 100. Higher scores indicate a more severe disability.|Before intervention, up to 12 weeks after intervention|Patients lost up to 12 weeks after intervention.|||score on a scale||Standard Deviation|Mean
2526455|NCT03679494|Secondary|Assess Patients' Decisional Conflict|Use the Decisional Conflict Scale to assess patients whether have a conflict or something not sure about making the decision. It has 16 items with 5 levels Likert scale. 0 points = yes, 1 point = about yes, 2 points = uncertainty, 3 points = probably not, 4 points = no. After the total score of each question is added, the initial total score is 0 to 64 points. Divide the initial total score by 16 and multiply by 25 to get the final score from 0 to 100. The higher the score, patients have more conflict with the decision.|After intervention immediately and up to 12 weeks after intervention|Patients lost after up to 12 weeks after intervention.|||score on a scale||Standard Deviation|Mean
2526456|NCT03679494|Secondary|Assess Patients' Satisfaction With Decision|Use Satisfaction with Decision Scale to assess patients satisfaction with health care decisions. It has 6 items with 5 level Likert scale. 1 point = very disagree, 2 points = disagree, 3 points = disagree or disagree, 4 points = agree, 5 points = very agree. After the total score of each question is added, the initial total score is 6 to 30 points. The higher the score, patients are more satisfied with the decision.|After intervention immediately, up to 12 weeks after the intervention|The patients lost up to 12 weeks after the intervention.|||score on a scale||Standard Deviation|Mean
2526457|NCT03679494|Secondary|Assess Decision Process Quality in Making the Decision|Assess whether the medical personnel have sufficiently communicated with patients when making the decision by 9-item Shared Decision Making Questionnaire(SDM-Q-9). It has 9 items and is divided into 0 to 5 scores, 0 points = very disagree, 1 point = roughly disagree, 2 points = partial disagreement, 3 points = partial consent, 4 points = roughly agree, 5 points = very agree. After the total score of each question is added, the initial total score is 0 to 45 points. Divide the initial total score by 9 and multiply by 20 to get the final score from 0 to 100. The higher the score means the better the decision-sharing on behalf of the patient.|After intervention immediately||||score on a scale||Standard Deviation|Mean
2526458|NCT03679494|Primary|The Change of Patients' Decision Self-efficacy|Use Decision Self Efficacy Scale to measure patients' self-confidence and belief in measuring the ability of patients to participate in decision-making. It has 11 items with 5 level Likert scale. The scale range is 0-100, higher scores indicate better decision self-efficacy.|Before intervention, after intervention immediately, up to 12 weeks after intervention|Patients lost after the intervention immediately and up to 12 weeks after intervention.|||score on a scale||Standard Deviation|Mean
2526459|NCT03679494|Primary|The Change of Patients' Control Preference|Use Control Preference Scale to measure the patients' preferred role whether change in making decisions with the medical provider before intervention and after intervention. It consists of five cards, each of which presents a different character in medical decision-making in a cartoon pattern, and performs a series of comparisons to rank the preference.|Before intervention, up to 12 weeks after intervention|Patients lost after 12 weeks of intervention.|||Participants|||Count of Participants
2526460|NCT03678870|Secondary|Additional Prescriptions|Percentage of patients obtaining additional prescriptions for pain|6 weeks postpartum||||Participants|||Count of Participants
2526461|NCT03678870|Secondary|Analgesic Quiz Score|Median score on an assessment of characteristics of analgesics including side effects, risks, and benefits. Score 1-10 for each question. Higher score is better.|6 weeks postpartum||||score on a scale||Inter-Quartile Range|Median
2526462|NCT03678870|Secondary|Disposed of Opioids Correctly|Frequency of women reporting that they either returned their unused opioids to a pharmacy or flushed them down the toilet|6 weeks postpartum|Denominator includes only women who had leftover opioids|||participants|||Number
2526463|NCT03678870|Primary|Opioid Use|Median number of tablets of hydrocodone-acetaminophen used after hospital discharge|6 weeks postpartum||||hydrocodone tablets||Inter-Quartile Range|Median
2526464|NCT03677375|Primary|Accuracy of Noninvasive Hemoglobin Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours||||g/dL|||Number
2526465|NCT03677245|Primary|Change in Physical Activity Based on the Patient Reported Outcome Measure Information System (PROMIS) Physical Activity Measure - Proxy Report|"PROMIS Physical Activity outcome measures assesses various aspects related to a child's participation in physical activity.The PROMIS measure has 10 items that parents rate on a 5-point likert scale. A 1 indicates that the child participated in the activity no days, 2 indicates that the child participated in the activity 1 day, 3 indicates that the child participated in the activity 2-3 days, 4 indicates that the child participated in the activity 4-5 days, and 5 indicates that the child participated in the activity 6-7 days. The PROMIS does not contain a total score."|3 months, 6 months|Data not reported due to participants not submitting completed PROMIS measure reports.||||||
2526782|NCT03634306|Secondary|Temperature at Time 15 Min|Temperature in degrees Celsius at 15 min during operative procedure|Intraoperative||||Degrees Celsius||Standard Deviation|Mean
2526466|NCT03677245|Primary|Change in Participation Level Based on the Participation and Environment Measure - Children and Youth (PEM-CY)|"The PEM-CY is participation level outcome measure used to assess a child's engagement in activities in the home, school, and community environments. The PEM-CY is a valid and reliable measure and is completed by parent/caregiver report, making it appropriate to use with children with DS. The PEM-CY asks questions related to 25 types of activiites that take place in the home, school, and community environments. Parents report how often their child has participated in each activity over the last 4 months (daily; few times a week; once a week; few times a month; once a month; few times in the last four months; once in the last four months; never); how involved their child is when participating in 1 or 2 activities that she or he does most often (5-very involved, 4, 3-somewhat involved, 2, 1-minimally involved); whether or not they want their child's participation to change and how they want it to change. The PEM-CY does not have scale scores or a total score."|3 months, 6 months|Data not reported due to not being collected secondary to participants submitting completed PEM-CYs.||||||
2526467|NCT03677245|Primary|Distance Biked|How far, up to 100', that the child can independently ride their Strider bike|Day 1 and day 5|Outcome of distance cycled assessed based on individual change scores (difference between distance cycled on day 1 and day 5). Group mean change scores also reported. No statistical analysis performed.|||feet||Standard Deviation|Mean
2526468|NCT03677245|Primary|Pediatric Balance Scale (PBS) Mean Group Score|The Pediatric Balance Scale (PBS) is a valid, 14-item assessment, developed based on the Berg Balance Scale, to assess balance in children. The PBS is a criterion-based measure, with each item scored on a 0-4 scale. The minimum score possible on the PBS is 0 points. The highest total score possible on the PBS is 56 points. Higher scores indicates better balance performance.The score reported is the mean PBS score of the group on day 5, the last day of the intervention.|Day 1 and Day 5||||score on a scale||Standard Deviation|Mean
2526469|NCT03677089|Secondary|Number of Co-morbidities in Children With ASD|The summary measure is defined as the mean number of co-morbidities reported among the four co-morbidities of interest for a child with ASD. Participants can be included in this outcome measure only if they have children with ASD seen in the 60 days prior to the chart review with an identified medical co-morbidity.|Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)|Participant numbers are based on the number of participants completing the appropriate form at the time points.|||number of co-morbid conditions per child||Standard Deviation|Mean
2526470|NCT03677089|Secondary|PCP ECHO Program Attendance|Percentage of the average number of sessions (out of 12) that the participant attended, of those who have completed the program.|At end of intervention (Month 6)||||percentage of sessions attended||Standard Deviation|Mean
2526471|NCT03677089|Secondary|Participant Satisfaction With ECHO Autism Program|"Participant satisfaction will be assessed using an unpublished 12-item survey developed for a previous ECHO Autism pilot study. The survey includes 10 questions assessing overall satisfaction with participation in the ECHO Autism clinic (rated on a 5-point Likert-type scale), and two questions asking for overall comments and suggestions. Participant satisfaction is defined as the percentage of participants who answer 2 = agree or 1 = strongly agree to question 1 (Participation in ECHO Autism improved my ability to care for children with autism in my practice)."|At end of intervention (Month 6)|Participant numbers are based on the number of participants completing the appropriate form at the time point.|||percentage of of satisfied participants|||Number
2526472|NCT03677089|Secondary|Longitudinal Pattern of the Number of Perceived Barriers to Care|"Perceived barriers to caring for children with autism in primary care will be assessed by participant response to an unpublished 9-item checklist and an open response other category for a total of 10 possible barriers. A maximum of 10 barriers can be reported and a minimum of 0. More reported barriers indicate more barriers to care."|Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)|Participant numbers are based on the number of participants completing the appropriate form at the time points.|||reported barriers (count out of 10)||Standard Deviation|Mean
2526473|NCT03677089|Secondary|Longitudinal Pattern of Scores on Provider ASD Self-Efficacy Assessment|"Self-Efficacy will be assessed at four time points using a 57-item unpublished questionnaire developed for a previous ECHO Autism pilot study.~The questionnaire is comprised of five domains: ASD screening and identification, ASD referral and resources, assessment and treatment of medical comorbidities, assessment and treatment of psychiatric comorbidities, and other items. Primary Care Providers report the degree to which they are confident in their ability to provide effective care in each domain. Items are rated on a 6-point Likert-type scale, where 1 = no confidence and 6 = highly confident/expert. Items are summed for a total score and five sub-scale scores. A subscale is marked as missing if more than 20% of responses are missing and the total score is marked as missing if any subscale is marked as missing or if 6 or more of the 57 questions have missing responses. These scores are then normalized to a percentage. Higher scores indicate greater perceived self-efficacy."|Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)|Participant numbers are based on the number of participants completing the appropriate form at the time points.|||score on a scale (0-100)||Standard Deviation|Mean
2526474|NCT03677089|Secondary|Longitudinal Pattern of Scores on Provider ASD Knowledge Assessment|"ASD knowledge will be assessed at four time points using a 33-item unpublished test developed specifically for the current study. The test assesses knowledge in the areas of ASD screening/identification, psychiatric co-morbidities, medical co-morbidities, and management of additional ASD-specific needs.~This test scores are based on the total number of correct answers, among all 33 questions. Any missing answers are counted as incorrect responses. Scores range from 0-100 with higher scores showing more knowledge of ASD."|Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)|Participant numbers are based on the number of participants completing the appropriate form at the time point.|||score on a scale (0-100)||Standard Deviation|Mean
2526501|NCT03673670|Secondary|Change From Baseline in AUC0-12h FEV1 on Day 1|Change from baseline FEV1 to AUC FEV1 over 12 hours post-dose after the morning dose on Day 1. The endpoint is measured as AUC/interval length (average) and measured in liters (Note: Endpoint is AUC/interval length (average) so the units are in liters.)|Change from pre-dose to each of the following timepoints: 5, 15 and 30 minutes and 1, 1.5, 2, 4, 6, 8, 12 hours on Day 1 (after the morning dose)|Full analysis set|||Liters||Standard Deviation|Mean
2526783|NCT03634306|Secondary|Temperature at Time 0 Min|Temperature in degrees Celsius at time 0 min during operative procedure|Intraoperative||||Degrees Celsius||Standard Deviation|Mean
2526475|NCT03677089|Primary|Longitudinal Pattern of Reported Co-occurring Medical Conditions Correctly Treated in PCP Charts|Clinical Practice/Behavior for treating co-occurring medical conditions will be assessed at four time points by review of a subset of charts from each Primary Care Provider's practice. All visits with an ASD will be reviewed. Data will be summarized into the percent of co-occurring medical conditions appropriately treated by each PCP.|Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)|Participants can be included in this outcome measure only if they have children with ASD seen in the 60 days prior to the chart review with an identified medical co-morbidity.|||percentage of co-morbid medical problems||Standard Deviation|Mean
2526476|NCT03677089|Primary|Longitudinal Pattern of ASD Screening in PCP Charts|Clinical Practice/Behavior for ASD screening will be assessed at four time points by review of a subset of charts from each Primary Care Provider's practice. Four subsets of charts will be reviewed for appropriate ASD screening occurring during well-child visits. Data will be summarized into the percent of children appropriately screened for ASD by each PCP.|Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)|Participants were not included if they were at the Canadian site because Canadian screening practices are different from the AAP recommendations used in the study. In addition, participants can be included in this outcome measure only if they have children with a well-child visit at 18 or 24 months in the 30 days prior to the chart review.|||percentage of children screened||Standard Deviation|Mean
2526477|NCT03676803|Secondary|Change From Baseline in Short-chain Fatty Acids (SCFAs) at 2 Weeks|Change from baseline in total SCFAs including acetate, propionate, butyrate and valerate in response to mixed-spice intervention for 2 weeks. SCFAs were measured in dry fecal sample determined as micromole per gram of dry weight.|2 weeks||||micromole/g||Standard Deviation|Mean
2526478|NCT03676803|Primary|Change in Microbial Phylum Abundance (% of Total) Between Spice and Placebo|Change in microbial phylum abundance (% of total) between spice and placebo after two week intervention|2-weeks|Data from one participant from spice group and one from placebo group were excluded due to non-compliance with the protocol.|||percentage of total bacteria||Standard Deviation|Mean
2526479|NCT03674177|Secondary|Anti-Respiratory Syncytial Virus Prefusion 3 (RSVPreF3) Immunoglobulin G (IgG) Antibody Concentrations||At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91)|||||||
2526480|NCT03674177|Secondary|Neutralizing Antibody (Nab) Titers Against RSV Serotype A||At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91)|||||||
2526481|NCT03674177|Secondary|Number of Subjects With SAEs|Assessed SAEs include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.|From Day 1 (vaccination) up to Day 91 and up to Day 181|The analysis was performed on the Exposed Set, which included all vaccinated subjects.|||Participants|||Count of Participants
2526482|NCT03674177|Primary|Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31|"Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration [FDA] Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 31]. Any corresponding to any grade and Grade 0 to normal ranges."|At Day 31|The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.|||Participants|||Count of Participants
2526483|NCT03674177|Primary|Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8|"Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration [FDA] Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 8]. Any corresponding to any grade and Grade 0 to normal ranges."|At Day 8|The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.|||Participants|||Count of Participants
2526484|NCT03674177|Primary|Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31|"Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease, Neutrophils Decrease, Platelets Decrease, WBC Decrease and WBC Increase, as graded by the Food and Drug Administration [FDA] Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 31]. Any corresponding to any grade and Grade 0 to normal ranges."|At Day 31|The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.|||Participants|||Count of Participants
2526493|NCT03674177|Primary|Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period|"Assessed solicited local symptoms include pain, redness and swelling, at the injection site. Any = occurrence of the AE regardless of intensity grade. Any Redness and swelling symptom = symptom reported with a surface diameter greater than 20 millimeters.~Grade 3 pain = significant pain at rest, pain that prevented normal every day activity. Grade 3 redness/swelling = symptom reported with a surface diameter greater than 100 millimeters."|During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days)|The analysis was performed on the Exposed Set, which included all subjects with the study vaccine administration documented.|||Participants|||Count of Participants
2526485|NCT03674177|Primary|Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8|"Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease, Neutrophils Decrease, Platelets Decrease, WBC Decrease and WBC Increase, as graded by the Food and Drug Administration [FDA] Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 8]. Any corresponding to any grade and Grade 0 to normal ranges."|At Day 8|The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.|||Participants|||Count of Participants
2526486|NCT03674177|Primary|Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31|Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine and blood urea nitrogen (BUN). Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) [e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 31].|At Day 31|The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.|||Participants|||Count of Participants
2526487|NCT03674177|Primary|Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8|Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine. Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR)[e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 8].|At Day 8|The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.|||Participants|||Count of Participants
2526488|NCT03674177|Primary|Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31|Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) [e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 31].|At Day 31|The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.|||Participants|||Count of Participants
2526489|NCT03674177|Primary|Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8|Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR). [e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 8].|At Day 8|The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.|||Participants|||Count of Participants
2526490|NCT03674177|Primary|Number of Subjects With Serious Adverse Events (SAEs) During a 30-day Follow-up Period|Assessed SAEs include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject.|From Day 1 (vaccination) up to Day 30 (i.e., on the day of vaccination and 29 subsequent days)|The analysis was performed on the Exposed Set, which included all vaccinated subjects.|||Participants|||Count of Participants
2526491|NCT03674177|Primary|Number of Subjects With Any Unsolicited AEs During a 30-day Follow-up Period|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During a 30-day follow-up period after vaccination (i.e., on the day of vaccination and 29 subsequent days)|The analysis was performed on the Exposed Set, which included all vaccinated subjects.|||Participants|||Count of Participants
2526492|NCT03674177|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period|"Assessed solicited general symptoms include fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and fever.~Any Fatigue, gastrointestinal symptoms and headache = occurrence of the symptom regardless of intensity grade and relationship. Any Fever = temperature higher than or equal to 38.0 degrees Celsius (°C), or 100.4 degrees Fahrenheit (°F).~Grade 3 Fatigue, gastrointestinal symptoms and headache = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than 39.0 degrees Celsius (°C), or 102.2 degrees Fahrenheit (°F).~Related fatigue, gastrointestinal symptoms, headache and fever(>38°C) = symptoms assessed by the investigator as related to the vaccination."|During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days)|The analysis was performed on the Exposed Set, which included all subjects with the study vaccine administration documented.|||Participants|||Count of Participants
2526494|NCT03673670|Secondary|Specific Airway Conductance on Day 3|Change in specific airway conductance during treatment|Change from pre-dose on Day 1 to the following timepoints: pre-dose, 1.25, 8.25 and 12.25 hours on Day 3 (after the morning dose)|Full analysis set|||1/kPa*sec||Standard Deviation|Mean
2526495|NCT03673670|Secondary|Specific Airway Conductance on Day 1|Change in specific airway conductance during treatment|Change from pre-dose to 1.25 hours on Day 1 (after the morning dose)|Full analysis set|||1/kPa*sec||Standard Deviation|Mean
2541462|NCT03023553|Primary|Number of Participants From Each Arm Who Received Influenza Vaccine||Day 0 to 28||||Participants|||Count of Participants
2526504|NCT03673670|Secondary|Change From Baseline in AUC0-12h FEV1 on Day 3|Change from baseline in AUC over 12 hours post-dose after the morning dose on Day 3. The endpoint is measured as AUC/interval length (average) and measured in liters (Note: Endpoint is AUC/interval length (average) so the units are in liters.)|Change from pre-dose to each of the following timepoints: 5, 15 and 30 minutes and 1, 1.5, 2, 4, 6, 8, 12 hours on Day 3 (after the morning dose)|Full analysis set|||Liters||Standard Deviation|Mean
2526505|NCT03673670|Secondary|Change From Baseline in AUC0-4h FEV1 on Day 3|Change from baseline FEV1 to AUC FEV1 over 4 hours post-dose after the morning dose on Day 3. The endpoint is measured as AUC/interval length (average) and measured in liters. (Note: Endpoint is AUC/interval length (average) so the units are in liters.)|Change from pre-dose to each of the following timepoints: 5, 15 and 30 minutes and 1, 1.5, 2, 4 hours on Day 3 (after the morning dose)|Full analysis set|||Liters||Standard Deviation|Mean
2526506|NCT03673670|Secondary|Change From Baseline to Trough FEV1 on Day 4|Change from baseline to morning trough FEV1 on Day 4|Change from pre-dose on Day 1 to pre-dose on Day 4|Full analysis set|||Liters||Standard Deviation|Mean
2526507|NCT03673670|Primary|Change From Baseline in Peak FEV1 on Day 3|Change from baseline FEV1 to peak FEV1 (measured as the greatest value in the 4 hours post-dose after the morning dose) on Day 3|Change from pre-dose at 5, 15 and 30 minutes and 1, 1.5, 2 & 4 hours on Day 3|Full analysis set|||Liters||Standard Deviation|Mean
2526508|NCT03670537|Primary|Percent of Non-anemic Patients With Iron Deficiency Stratified by Gravidity|Either low serum ferritin or low percent transferrin saturation (TSAT)|Day 1 presentation to obstetrician||||Participants|||Count of Participants
2526509|NCT03669081|Secondary|30 Day Mortality|Primary outcomes include 30 day mortality post-operatively.|30 days||||Participants|||Count of Participants
2526510|NCT03669081|Secondary|Number of Patients With Urinary Retention|Patients were evaluated post-operatively during hospital stay for instances of urinary retention.|82.25 hours||||Participants|||Count of Participants
2526511|NCT03669081|Secondary|Bleeding Risk|Hematocrit levels were evaluated post-operatively for up to a day post-operatively for signs of blood loss.|24 hours||||percentage of hematocrit||Standard Deviation|Mean
2526512|NCT03669081|Secondary|Serum Creatinine Levels at One Year Post-operatively|Renal function was evaluated by following serum creatinine levels for up to one year post-operatively.|1 year||||mg/dL||Inter-Quartile Range|Median
2526513|NCT03669081|Primary|Length of Hospital Stay|Primary outcomes include length of hospital stay (LOS).|82.25 hours||||hours||Inter-Quartile Range|Median
2526514|NCT03669081|Primary|Cumulative Narcotic Use|Cumulative narcotic use was defined by cumulative morphine equivalents over the course of a patient's hospital course. The Washington State Agency Medical Director's Group Opioid dose calculator was used to provide a total morphine dose equivalent (MDE) for each patient while in the hospital.|82.25 hours||||mg||Inter-Quartile Range|Median
2526515|NCT03667547|Secondary|Apparent Volume of Distribution (Vz/F) of Raltegravir|Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The apparent volume of distribution of raltegravir during the terminal phase (Vz/F) was reported.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing|Participants meeting the protocol criteria likely to provide data that sufficiently reflects the effect of treatment under the scientific model. These included measures such as the exposure to study drug, the availability of measurements, and the absence of significant protocol deviations.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2526516|NCT03667547|Secondary|Apparent Total Plasma Clearance (CL/F) of Raltegravir|Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The apparent total plasma clearance of raltegravir after oral dosing (CL/F) was reported.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing|Participants meeting the protocol criteria likely to provide data that sufficiently reflects the effect of treatment under the scientific model. These included measures such as the exposure to study drug, the availability of measurements, and the absence of significant protocol deviations.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2526517|NCT03667547|Secondary|Apparent Plasma Half-life (t1/2) of Raltegravir|Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The apparent plasma half-life (t1/2) of raltegravir was reported.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing|Participants meeting the protocol criteria likely to provide data that sufficiently reflects the effect of treatment under the scientific model. These included measures such as the exposure to study drug, the availability of measurements, and the absence of significant protocol deviations.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2526518|NCT03667547|Secondary|Time of Maximum Plasma Concentration (Tmax) of Raltegravir|Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The time at which Cmax of plasma raltegravir is achieved (Tmax) was reported.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing|Participants meeting the protocol criteria likely to provide data that sufficiently reflects the effect of treatment under the scientific model. These included measures such as the exposure to study drug, the availability of measurements, and the absence of significant protocol deviations.|||Hours||Full Range|Median
2526519|NCT03667547|Secondary|Plasma Concentration of Raltegravir at 24 Hours After Dosing (C24)|Blood samples were collected at 24 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. The plasma concentration of raltegravir at 24 hours after dosing (C24) was calculated based on natural log-transformed values.|24 hours after dosing|Participants meeting the protocol criteria likely to provide data that sufficiently reflects the effect of treatment under the scientific model. These included measures such as the exposure to study drug, the availability of measurements, and the absence of significant protocol deviations.|||nM||95% Confidence Interval|Geometric Mean
2526784|NCT03634306|Secondary|Duration of Intra-abdominal Pressure Increase|Duration spent at first intra-abdominal pressure increase from the initial 10mmHg set point|Intraoperative||||minutes||Standard Deviation|Mean
2526520|NCT03667547|Secondary|Maximum Plasma Concentration (Cmax) of Raltegravir|Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. Maximum plasma concentration (Cmax) of raltegravir was calculated based on natural log-transformed values.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing|Participants meeting the protocol criteria likely to provide data that sufficiently reflects the effect of treatment under the scientific model. These included measures such as the exposure to study drug, the availability of measurements, and the absence of significant protocol deviations.|||nM||95% Confidence Interval|Geometric Mean
2526521|NCT03667547|Secondary|Area Under the Concentration-Time Curve Up to Infinity (AUC0-∞) of Plasma Raltegravir|Blood samples were collected from pre-dose up to 48 hours post-dose in order to measure the concentration of plasma raltegravir. Values below the lower limit of quantitation were replaced with 0. Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of plasma raltegravir was calculated based on natural log-transformed values.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, and 48 hours after dosing|Participants meeting the protocol criteria likely to provide data that sufficiently reflects the effect of treatment under the scientific model. These included measures such as the exposure to study drug, the availability of measurements, and the absence of significant protocol deviations.|||(μM•hr)||95% Confidence Interval|Geometric Mean
2526522|NCT03667547|Primary|Number of Participants With a Drug-related AE|The number of participants with a drug-related AE was reported. Causality was be determined by the investigator.|Up to Day 14 after dosing|All participants who received at least one dose of the study drug|||Participants|||Count of Participants
2526523|NCT03667547|Primary|Number of Participants With a Serious Adverse Event (SAE)|A SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly or birth defect, is another medically important event, is a new cancer, or is an overdose. The number of participants with an SAE was reported.|Up to Day 14 after dosing|All participants who received at least one dose of the study drug|||Participants|||Count of Participants
2526524|NCT03667547|Primary|Number of Participants Discontinued From the Study Due to an AE|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a study drug, whether or not considered related to the study drug. The number of participants discontinued from the study due to an AE was reported.|Up to Day 14 after dosing|All participants who received at least one dose of the study drug|||Participants|||Count of Participants
2526525|NCT03667547|Primary|Number of Participants With an Adverse Event (AE)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a study drug, whether or not considered related to the study drug. The number of participants with an AE was reported.|Up to Day 14 after dosing|All participants who received at least one dose of the study drug|||Participants|||Count of Participants
2526526|NCT03664544|Secondary|Pharmacokinetic Parameters of MCI-186: Unbound Total Clearance (Clu)|Unchanged MCI-186|Day 1 to 3|PK population|||L/h||Standard Deviation|Mean
2526527|NCT03664544|Secondary|Pharmacokinetic Parameters of MCI-186: Unbound Area Under the Concentration-time Curve From Time Zero to Infinity (AUCu0-∞)|Unchanged MCI-186|Day 1 to 3|PK population|||h*ng/mL||Standard Deviation|Mean
2526528|NCT03664544|Secondary|Pharmacokinetic Parameters of MCI-186: Mean Residence Time (MRT)|Unchanged MCI-186|Day 1 to 3|PK population|||h||Standard Deviation|Mean
2526529|NCT03664544|Secondary|Pharmacokinetic Parameters of MCI-186: Volume of Distribution During the Terminal Phase (VZ)|Unchanged MCI-186|Day 1 to 3|PK population|||L||Standard Deviation|Mean
2526530|NCT03664544|Secondary|Pharmacokinetic Parameters of MCI-186: Volume of Distribution at Steady State (Vss)|Unchanged MCI-186|Day 1 to 3|PK population|||L||Standard Deviation|Mean
2526531|NCT03664544|Secondary|Pharmacokinetic Parameters of MCI-186: Total Clearance (CL)|Unchanged MCI-186|Day 1 to 3|PK population|||L/h||Standard Deviation|Mean
2526532|NCT03664544|Secondary|Pharmacokinetic Parameters of MCI-186: Terminal Elimination Rate Constant (λZ)|Unchanged MCI-186|Day 1 to 3|PK population|||/h||Standard Deviation|Mean
2526533|NCT03664544|Secondary|Pharmacokinetic Parameters of MCI-186: Time to Reach Peak Concentration (Tmax)|Unchanged MCI-186|Day 1 to 3|PK population|||h||Full Range|Median
2526534|NCT03664544|Secondary|Pharmacokinetic Parameters of MCI-186: Half-life (t½)|Unchanged MCI-186|Day 1 to 3|PK population|||h||Standard Deviation|Mean
2526535|NCT03664544|Secondary|Incidence of Adverse Events (AEs) and Serious Adverse Events|Number of adverse events|Day -1 to Day 7|Safety Analysis Set|||Events|||Number
2526536|NCT03664544|Primary|Pharmacokinetic Parameters of MCI-186: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞)|Unchanged MCI-186|Day 1 to 3|PK population|||h*ng/mL||Standard Deviation|Mean
2526537|NCT03664544|Primary|Pharmacokinetic Parameters of MCI-186: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last)|Unchanged MCI-186|Day 1 to 3|PK population|||h*ng/mL||Standard Deviation|Mean
2526538|NCT03664544|Primary|Pharmacokinetic Parameters of MCI-186: Peak Drug Concentration (Cmax)|Unchanged MCI-186|Day 1 to 3|PK population|||ng/mL||Standard Deviation|Mean
2526539|NCT03663179|Secondary|Change in Performance on Conners Continuous Performance Task (Sustained Attention)|The Conners Continuous Performance Task (Conners CPT) will be administered and baseline and weekly during the treatment period to assess sustained attention. In this task, participants are shown a series of letters on a computer screen and are asked to press the spacebar in response to all letters except for the letter X. The primary outcome for the Conners CPT is the change in number of commission errors (e.g., false positives) from baseline to week 4.|Baseline and week 4||||Commission Errors||Standard Deviation|Mean
2526557|NCT03662139|Secondary|Four Square Step Test (FSST)|FSST, assesses dynamic balance and coordination through stepping forwards, sideways, and backwards in a timed fashion. It is a valid and reliable tool in children with cerebral palsy. The test requires the participant to step forwards, backwards and sideways over four-square shaped line in a specified sequence. Completion time is recorded for the task and longer time indicates worse ambulation and higher risk of fall.|Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)|Cerebral palsy group is assessed 2 times in a 7-10 days period for the test-retest reliability. Control group is assessed only once.|||seconds||Full Range|Median
2526540|NCT03663179|Primary|Change in Performance on Conners Adult ADHD Rating Scale - Self-Report: Long Version (ADHD Symptoms)|ADHD symptoms will be assessed using the well-validated Conners Adult ADHD Rating Scale - Self-Report: Long Version (CAARS-S:L). The CAARS-S:L is a 66-item rating scale designed to assess ADHD symptoms in adults. The scale contains multiple subscales to assess Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) specified ADHD criteria as well as other facets of ADHD such as inattention/memory problems, hyperactivity/restlessness, impulsivity/emotionality, and problems with self-concept. Subscale results are converted to T-scores (range: 25-90), where 50 is the standardized population mean and every 10 points indicates one standard deviation from the mean. Higher values generally indicate more difficulties with ADHD symptoms. This measure will be administered at baseline at at the end of 4 weeks of treatment. The primary outcome will be the change from baseline to week 4.|Baseline and week 4||||t-score||Standard Deviation|Mean
2526541|NCT03662334|Secondary|Part 3: Insulin Analog Serum Concentration as a Function of Time Following Termination of Insulin Infusion||up to approximately 12 hours|The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.||||||
2526542|NCT03662334|Secondary|Part 3: Plasma Glucose Concentration Over Time||up to approximately 12 hours|The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.||||||
2526543|NCT03662334|Secondary|Part 2: Insulin Analog Serum Concentration as a Function of Time Following Bolus Insulin Infusion|Insulin analog serum concentration is reported as the maximum concentration for any participant receiving each treatment sequence. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.|up to approximately 10 hours|Safety Population|||picomolar|||Number
2526544|NCT03662334|Secondary|Part 2: Plasma Glucose Concentration Over Time|Plasma glucose concentration over time is reported as the maximum concentration for any participant receiving each treatment sequence. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.|up to approximately 10 hours|Safety Population|||mg/dL|||Number
2526545|NCT03662334|Secondary|Part 1: Mean Residence Time (MRT)||up to approximately 22 hours|The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.||||||
2526546|NCT03662334|Secondary|Part 1: Area Under the Curve From Time Zero to the Last Measureable Concentration (AUC0-last)||up to approximately 22 hours|The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.||||||
2526547|NCT03662334|Secondary|Part 1: Fractional and Absolute AUC2hr-end||2 to approximately 22 hours|The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.||||||
2526548|NCT03662334|Secondary|Part 1: Fractional and Absolute AUC0-1hr||0 to 1 hour|The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.||||||
2526549|NCT03662334|Secondary|Part 1: Time to 50% of Total AUC (AUC0-last)||up to approximately 22 hours|The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.||||||
2526550|NCT03662334|Secondary|Part 1: Early Time to 50% Maximum Serum Insulin Concentration (t50%) Max||up to approximately 22 hours|The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.||||||
2526551|NCT03662334|Secondary|Part 1: Time to Achieve Maximum Concentration (Tmax)||up to approximately 22 hours|The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.||||||
2526552|NCT03662334|Secondary|Part 1: Mean Maximum Concentration (Cmax)||up to approximately 22 hours|The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.||||||
2526553|NCT03662334|Secondary|Part 1: Time-action Profile, Assessed by GIR in Euglycemic Participants||up to approximately 10 hours|The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.||||||
2526554|NCT03662334|Primary|Part 3: Time to Achieve Plasma Glucose >90 mg/dL After Release of Hypoglycemic CSII Clamp||0-12 hours|The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.||||||
2526555|NCT03662334|Primary|Part 2: Time to Reduction in Plasma Glucose by 80 Milligrams Per Deciliter (mg/dL) Following CSII Bolus|Time to reduction is reported as the maximum time it took for any participant receiving each treatment sequence to achieve a reduction in plasma glucose by 80 mg/dL. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.|0-10 hours|Safety Population: all randomized participants exposed to at least one dose of study drug|||hours|||Number
2526556|NCT03662334|Primary|Part 1: Area Under the Curve (AUC) of Glucose Infusion Rate (GIR) From 0-6 Hours||0-6 hours|The study was stopped early, prior to enrolling the planned 24 participants. As a result, data were not collected for analysis of this outcome measure. Only Part 2 of the study was conducted.||||||
2545579|NCT02940327|Secondary|Change of Serum Haemoglobin Levels|Clinical and biochemical markers of organ failure|baseline||||g/L||Standard Deviation|Mean
2526558|NCT03662139|Secondary|Timed Up and Go Test (TUG)|TUG is a test determining fall risk and balance by their physical performance in sitting to standing, and walking. Test begins with the patient sitting back in a standart chair and when asked walking 10 feets on a certain line than back to the chair sitting. Completion time is recorded for the task and longer time indicates worse ambulation and higher risk of fall.|Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)|Cerebral palsy group is assessed 2 times in a 7-10 days period for the test-retest reliability. Control group is assessed only once.|||seconds||Full Range|Median
2526559|NCT03662139|Secondary|Pediatric Balance Scale (PBS)|Pediatric Balance Scale is a functional balance scale adapted and customized from Berg Balance Scale for use with children. Pediatric Balance Scale is a 14-item, criterion-referenced measure, which examines functional balance in the context of everyday tasks. It can easily be administered and scored in less than 20 minutes using equipment commonly found in schools and clinics. Scoring (0-4) is based on how long a specific movement or position is performed, how long the position can be maintained, or how much assistance it requires. Minimum score is 0, maximum score is 56; higher scores indicate better dynamic balance.|Only Day 1 in both Cerebral Palsy and Healthy control groups (Cerebral Palsy group same day by two different evaluators)|Cerebral palsy group is assessed 2 times in a 7-10 days period for the test-retest reliability. Control group is assessed only once.|||units on a scale||Full Range|Median
2526560|NCT03662139|Primary|Dynamic Gait Index (DGI)|Dynamic Gait Index is a tool consisting eight items; gait on a flat surface, changing speed, gait with horizontal and vertical head turns, pivot turn, stepping over obstacle, Minimum score is 0, maximum score is 24, higher scores indicate better outcome. Scores lower than 19 indicate risk of falling and above 22 define safe ambulance.|Day 1 (Baseline) in both groups (Cerebral Palsy group same day by two different evaluators), Day 7-10 in the Cerebral Palsy group only|Cerebral palsy group is assessed 2 times in a 7-10 days period for the test-retest reliability. Control group is assessed only once.|||units on a scale||Full Range|Median
2526561|NCT03661697|Primary|Change in Skin Tone|Change in skin tone is assessed using the Modified Pigmentation Area and Severity Index (MoPASI). MoPASI assesses three facial region variables: 1) A = % area of involvement (0 = no involvement, 6 = 90% involvement), 2) D = darkness of pigment (0=absent, 4=maximum), 3) P = pattern of involvement (0=absent, 4=maximum). Four facial regions will be assessed: Forehead (0.2A), Left Cheek and periorbital (0.3A), Right Cheek and periorbital (0.3A), Nose/Lip/Chin (0.2A). The Total score ranges from 0-48 and is calculated using the formula: MoPASI = 0.2A(D + P) + 0.3A (D+P) + 0.3A (D+P) + 0.2A (D+P). A higher score indicates higher pigmentation.|baseline to 12 weeks||||score on a scale||Inter-Quartile Range|Median
2526562|NCT03661697|Primary|Change in Aesthetics|Blinded evaluation using Global Aesthetic Improvement Scale (GAIS) (0=worse, 4=very much improved)|baseline to 12 weeks||||score on a scale||Inter-Quartile Range|Median
2526563|NCT03660787|Secondary|Number of Participants With Detection of no Ultrasound Signs of Pelvic Adhesive Disease Post Surgery|No limited mobility of pelvic organs and no hyperechoic linear lesions should be shown|30±4 days after surgery||||Participants|||Count of Participants
2526564|NCT03660787|Secondary|Change Number of Participants in Detecting Hyperechoic Linear Lesions|Frequency of detecting after repeated transvaginal ultrasound results was compared to baseline indications (4 or more)|30±4 days after surgery||||participants|||Number
2526565|NCT03660787|Secondary|Change in Number of Participants in Detecting Pelvic Organs Limited Mobility|Absolute change of count of participants was measured with detecting pelvic organs limited mobility from the baseline|30±4 days after surgery||||participants|||Number
2526566|NCT03660787|Secondary|Number of Participants With Detection of Hyperechoic Linear Lesions Post Surgery|The frequency was estimated based on transvaginal ultrasound results|30±4 days after surgery||||participants|||Number
2526567|NCT03660787|Secondary|Number of Participants With Detection of Pelvic Organs Limited Mobility|The frequency was estimated based on transvaginal ultrasound results|30±4 days after surgery||||participants|||Number
2526568|NCT03660787|Secondary|Change in Thickness of Pelvic Adhesions|The change from baseline was defined. It was evaluated by comparing baseline MRI data and repeated MRI data. Results were estimated according to scale from 0 to 3 where 0 - no adhesions, 1 - thin (filmy or filiform), 2 - marked, 3 - marked with an impaired passage through organs involved.|30±4 days after surgery|7 patients had no results of repeated Pelvic MRI examination that is why the number of Participants is different|||score on a scale||Full Range|Median
2526569|NCT03660787|Primary|Number of Participants With Reduction of Adhesions Number by 3 or More|The number of adhesions according to the first MRI data was compared to the number according to the data of second MRI|30±4 days after surgical intervention|7 patients had no results of repeated Pelvic MRI examination that is why the number of Participants is different|||Participants|||Count of Participants
2526570|NCT03658876|Primary|Hemoglobin Incrementation|Incrementation of haemoglobin of 5g/l following treatment|Within 2 months||||Participants|||Count of Participants
2526571|NCT03658811|Secondary|Measure of Visual Analog Scale Pain|measure of pain since last visit on scale of minimum of 0 mm (no pain)- maximum of 100 mm (maximal pain and worse outcome)|2 weeks||||millimeters||Standard Deviation|Mean
2526572|NCT03658811|Secondary|Ocular Discomfort Frequency Assessment on Visual Analog Scale|scale of minimum of 0 mm (no episodes)-maximum of 100 mm (constant painful episodes and worse outcome) frequency of dry eye pain episodes|24 hours||||millimeters||Standard Deviation|Mean
2526573|NCT03658811|Secondary|Measure of Visual Analog Scale Pain Over Last 24 Hours|measure (in millimeters) of pain on scale of minimum of 0 mm(no pain)- maximum of 100mm (maximal pain and worse outcome)|24 hours||||millimeters||Standard Deviation|Mean
2526574|NCT03658811|Primary|Non-invasive Tear Break up Time (TBUT)|average of 3 measurements (in seconds) using fluorescein dye and stopwatch to monitor first sign of tear film break up|2 weeks||||seconds||95% Confidence Interval|Mean
2526575|NCT03657407|Secondary|Number of Participants for Which Anti-emetics Were Received in PACU|Binary assessment of whether anti-emetics received in PACU|up to 4 hours||||Participants|||Count of Participants
2526576|NCT03657407|Secondary|Time Until Cleared for PACU Discharge|Time elapsed from conclusion of surgery until criteria for PACU discharge met|up to 4 hours||||minutes||Standard Deviation|Mean
2526577|NCT03657407|Secondary|Narcotic Use|Cumulative oral and intravenous narcotics received in PACU until PACU discharge criteria met|up to 4 hours||||Oral Morphine Equivalents in mg||Standard Deviation|Mean
2526579|NCT03657264|Secondary|Predicted Value of ∆∆QTc at Cmax|Concentration-response relationship was investigated between ∆QTc and P03277 concentrations using a mixed model approach. Plasma concentration of P03277 was measured at the same timepoints as ECG measurements.|from 1 hour before any administration until 24 hours post-administration.||||milliseconds||90% Confidence Interval|Number
2526580|NCT03657264|Secondary|Change-from-baseline Mean Effect of Moxifloxacin on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)|Each subject was monitored with a 12-lead Holter electrocardiogram (ECG). The assay sensitivity was assessed through this outcome. The difference between the positive control (moxifloxacin) and placebo for the largest mean change from baseline for the QTcF had to be greater than 5 milliseconds for at least one time point. The baseline was defined as the mean of the 3 triplicates ECG measured within 1 hour before each product administration.|from 1 hour before any administration until 4 hours post-administration at the following timepoints: -1 hour, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours.|Analysis of secondary criteria was performed using the full analysis set which included all randomized subjects.|||milliseconds||Standard Error|Least Squares Mean
2526581|NCT03657264|Primary|Change-from-baseline Mean Effect of P03277 on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF)|"Each subject was monitored with a 12-lead Holter electrocardiogram (ECG). The study had to show that both 0.1 and 0.3 mmol/kg doses of P03277 do not increase the QT interval corrected by Fridericia formula (QTcF).~The study is successful if the difference between each of the two doses of P03277 and placebo for the largest mean change from baseline for the QTcF is lower than 10 milliseconds. The baseline was defined as the mean of the 3 triplicates ECG measured within 1 hour before each product administration."|from 1 hour before any administration until 24 hours post-administration at the following timepoints: -1 hour, 5 min, 10 min, 20 min, 30 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 24 hours.|The primary analysis was performed using the per protocol set which included subjects who had no major protocol deviations throughout their whole study period.|||milliseconds||Standard Error|Least Squares Mean
2526582|NCT03655301|Secondary|Maximum Change From Baseline in Plasma Lactate Levels|Lactate levels were analyzed in plasma samples collected during metformin alone or in combination with copanlisib. Maximum change from baseline on Day 1 and Day 8 was summarized.|From pre-dose up to 24 hours after study drug administration on Day 1 and Day 8|Safety Analysis Set (SAF): included all participants who received at least one dose of the study medication.|||mmol/L||Full Range|Mean
2526583|NCT03655301|Secondary|Plasma Lactate Levels|Lactate levels were analyzed in plasma samples collected during metformin alone or in combination with copanlisib. Plasma lactate levels were summarized by treatment conditions (Day 1 and Day 8).|Up to 24 hours after study drug administration on Day 1 and Day 8|Safety Analysis Set (SAF): included all participants who received at least one dose of the study medication.|||mmol/L||Full Range|Mean
2526584|NCT03655301|Secondary|Number of Participants With Treatment-Emergent Adverse Events by Severity|An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened after the start of study drug administration up to 30 days after last administration of the study medication. TEAEs per severity were reported.|From start of study medication until 30 days after end of treatment with study medication.|Safety Analysis Set (SAF): included all participants who received at least one dose of the study medication.|||Participants|||Count of Participants
2526585|NCT03655301|Secondary|Number of Participants With Treatment-Emergent Adverse Events|An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened after the start of study drug administration up to 30 days after last administration of the study medication.|From start of study medication until 30 days after end of treatment with study medication.|Safety Analysis Set (SAF): included all participants who received at least one dose of the study medication.|||Participants|||Number
2526586|NCT03655301|Primary|Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity of Metformin After Single Dose Administration (AUC)|Area under the concentration verus time curve from zero to infinity of metformin after single dose without copanlisib (Day 1) and in combination with copanlisib (Day 8) were measured.|Pre-dose and extrapolated up to infinity after drug administration on Day 1 and Day 8|Pharmacokinetic Analysis Set (PKS) with valid data for this evaluation.|||microgram*hour per liter (mcg*h/L)||Geometric Coefficient of Variation|Geometric Mean
2526587|NCT03655301|Primary|Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours of Metformin After Single Dose Administration (AUC[0-24])|Area under the concentration versus time curve from zero to 24 hours of metformin after single dose administration without copanlisib (Day 1) and in combination with copanlisib (Day 8) were measured.|Pre-dose and up to 24 hours after drug administration on Day 1 and Day 8|Pharmacokinetic Analysis Set (PKS): included all participants with a valid PK profile for metformin.|||microgram*hour per liter (mcg*h/L)||Geometric Coefficient of Variation|Geometric Mean
2526588|NCT03655301|Primary|Maximum Drug Concentration of Metformin in Plasma After Single Dose Administration (Cmax)|Maximum observed drug concentration of metformin in plasma after single dose administration without copanlisib (Day 1) and in combination with copanlisib (Day 8) were measured.|Pre-dose and up to 24 hours after drug administration on Day 1 and Day 8|Pharmacokinetic Analysis Set (PKS): included all participants with a valid PK profile for metformin.|||microgram per liter (mcg/L)||Geometric Coefficient of Variation|Geometric Mean
2526589|NCT03655106|Secondary|Infection|Number of patient with infection as defined as the patient meeting the laboratory-confirmed bloodstream infection criteria as defined by the Centers for Disease Control.|30 days||||Participants|||Count of Participants
2526590|NCT03655106|Secondary|Thrombosis|Number of patient with thrombosis upper extremity superficial or deep venous thrombosis as measured by venous doppler study in symptomatic patients|30 days||||Participants|||Count of Participants
2526591|NCT03655106|Primary|Duration of IV Survival|Function is defined by a catheter's ability to draw back 5 ml of blood, flush with 5 ml normal saline without resistance, or if IV fluids or medication are continually infusing through the IV. Function is assessed daily by research staff.|30 days||||hours||95% Confidence Interval|Median
2526785|NCT03634306|Secondary|Number of Participants With Adjusted Intra-abdominal Pressure|The number of participants who had an adjustment in intra-abdominal pressure during the procedure|Intraoperative||||Participants|||Count of Participants
2526592|NCT03654417|Post-Hoc|Possible Pathologic Changes Associated With EMLA Cream Application|To address the concern that EMLA might induce pathologic changes that could result in altered diagnosis, pathologist independent from initial diagnostic read will re-evaluate tissue slides and look for the previously described EMLA induced pathologic changes (pallor, necrosis, spongiosis, basophilic granules, acantholysis, clefting, papillary dermal edema). Pathologist will be blinded to whether or not patient received EMLA cream for biopsy. They will provide a score for all specimens that will be used to analyse any pathologic differences between patients exposed to EMLA and those not exposed to EMLA.|retrospective|||||||
2526593|NCT03654417|Secondary|Provider's Overall Satisfaction With the Procedure as Measured by a Scale|"provider-reported measure of how well they believe the procedure went~title: Overall, how satisfied are you with the procedure performed today? min: 0 (completely satisfied) max: 100 (not at all satisfied)"|Up to 30 minutes after the procedure||||units on a scale (mm)||Inter-Quartile Range|Median
2526594|NCT03654417|Secondary|Provider's Opinion of Subject Tolerance as Measured by a Scale|"provider-reported measure of how well they believe the patient tolerated the procedure~title: Overall, how well did the subject tolerate the procedure today? min: 0 (well tolerated) max: 100 (poorly tolerated)"|Up to 30 minutes after the procedure||||units on a scale (mm)||Inter-Quartile Range|Median
2526595|NCT03654417|Secondary|Tolerance of Procedure as Measured by a Satisfaction Scale|"self-reported tolerance of the procedure meant to assess a patient's tolerance through a scale~Title: Please slide the tab along the line below to indicate, overall, how you would rate the experience of your biopsy procedure today Min: 0 (I could easily handle having this procedure again) Max: 100 (I could never have this procedure done again)"|Up to 30 minutes after the procedure||||units on a scale (mm)||Inter-Quartile Range|Median
2526596|NCT03654417|Secondary|Acceptance of the Procedure as Measured by a Satisfaction Scale|"self-reported acceptance of the procedure meant to assess a patient's acceptability through a scale~title: Please slide the tab along the line below to indicate, overall, how acceptable the procedure performed today was min: 0 (completely acceptable) max: 100 (not at all acceptable)"|up to 30 minutes after the procedure||||units on a scale (mm)||Inter-Quartile Range|Median
2526597|NCT03654417|Secondary|Generalized Anxiety Disorder 7-item (GAD-7) Score for Baseline Anxiety|Self-reported anxiety score meant to assess a patient's baseline level of anxiety. The score ranges from 0 (minimal anxiety) to 21 (severe anxiety).|no more than 30 minutes before the procedure||||Participants|||Count of Participants
2526598|NCT03654417|Secondary|Anxiety Before the Procedure as Measured by an Anxiety Scale|"self-reported level of anxiety immediately prior to the start of the procedure~title: Slide the tab along the line below to indicate how nervous you feel about the procedure you are about to have min: 0 (not nervous) max: 100 (very nervous)"|No more than 30 minutes before the procedure||||units on a scale (mm)||Inter-Quartile Range|Median
2526599|NCT03654417|Secondary|Baseline Vulvar Pain|self-reported level of vulvar pain immediately prior to the start of the procedure title: Please slide the tab along the line below to indicate pain in the area of your vulva (external genitalia) during biopsy min: 0 (no pain) max: 100 (worst pain imaginable)|no more than 30 minutes prior to procedure||||units on a scale (mm)||Inter-Quartile Range|Median
2526600|NCT03654417|Secondary|Pain During Biopsy as Measured by a Pain Scale|"self-reported level of pain following the biopsy~title: Please slide the tab along the line below to indicate pain in the area of your vulva (external genitalia) during biopsy min: 0 (no pain) max: 100 (worst pain imaginable)"|No more than 5 minutes after receiving the biopsy||||units on a scale (mm)||Inter-Quartile Range|Median
2526601|NCT03654417|Primary|Highest Pain Score|"The highest pain score recorded (at time of numbing or at time of biopsy) controlled for baseline pain~title: Please slide the tab along the line below to indicate pain in the area of your vulva (external genitalia) during numbing OR biopsy min: 0 (no pain) max: 100 (worst pain imaginable)"|no more than 5 minutes after numbing or 5 minutes after biopsy||||units on a scale (mm)||Inter-Quartile Range|Median
2526602|NCT03653429|Secondary|Post Operative Narcotic Consumption|Post operative narcotic consumption, morphine mili equivalents|2 weeks after surgery||||MME||Standard Deviation|Mean
2526603|NCT03653429|Secondary|Intra Operative Narcotic Consumption|Total intraoperative narcotic consumption in terms of morphine equivalents.(mme)|Average intra operative time 1-2 hours||||MME||Standard Deviation|Mean
2526604|NCT03653429|Secondary|Number of Participants With Wound Complications|Number of participants with wound complications at first post-operative visit and at 2 weeks post surgery|at first post-operative visit, 2 weeks post surgery||||Participants|||Count of Participants
2526605|NCT03653429|Primary|Total Estimated Blood Loss|Total estimated blood loss in millilitres during the surgery|Average intra operative time 1-2 hours||||ml||Standard Deviation|Mean
2526606|NCT03651856|Primary|Number of Participants With Treatment Emergent Adverse Events|Evaluate the safety of Atomoxetine 40mg bid in PD patients with FOG (Freezing of Gait)|week 8||||Participants|||Count of Participants
2526607|NCT03651479|Secondary|Frenchay Activities Index|Frenchay Activities Index is a measure of instrumental activities of daily living (IADL) for use with patients recovering from stroke. The Frenchay Activities Index (FAI) assesses a broad range of activities associated with everyday life. The benefit of the FAI is that while activities of daily living scales tend to focus on issues related to self-care and mobility. The FAI comprises 15 activities, each of which is scored on a 4-point scale (0 to 3), to yield a total score ranging from 0 (inactive) to 45 (active). Scoring is based on the frequency with which the activities are carried out. It can be broken down into three subscales: domestic chores, leisure/work, and outdoor activities. Each subscale's score ranges from 0 to 15.|8 weeks||||score on a scale||Standard Deviation|Mean
2526608|NCT03651479|Secondary|Addenbrooke's Cognitive Assessment|Addenbrook's Cognitive Assessment - Revised (ACE-R) is sensitive in the differential diagnosis of early stage dementia. However, the design and psychometric properties is also suitable to provide information about cognitive functions and cognitive deficits in patients without dementia after a stroke. The ACE-R consists of five domains including attention/orientation, memory, verbal fluency, language and visuospatial ability. The ACE-R total scale score ranges from 0 to 100. The ACE-R subscale scores ranges between; 0-18 points for attention, 0-26 for memory, 0-14 for fluency, 0-26 for language and 0-16 for visuospatial processing. Higher scores indicate better cognitive functioning. ACE- R scale was found as reliable and valid in Turkish population.|8 weeks||||score on a scale||Standard Deviation|Mean
2526609|NCT03651479|Secondary|Fullerton Advanced Balance Scale|Fullerton Advanced Balance (FAB) scale was developed to evaluate sensitive changes in many aspects of balance. This performance-based scale consists of 10 test items assessing functional balance (static and dynamic) status in older people. The individual test items are: 1. Feet together, eyes closed, 2. Reach forward to retrieve an object, 3. Turn in a full circle, 4. Step up and over a bench, 5. Tandem walk, 6. Stand on one leg, 7. Stand on foam, eyes closed, 8. Two-footed jump, 9. Walk with head turns, 10. Reactive postural control. Each test item is scored using a 0-4 scale. The highest score that can be obtained on this multidimensional balance assessment is 40 points, and the lowest is zero. Higher scores indicate better balance abilities. The FAB scale is quick to administer (~10-12 minutes) and can be administered in a relatively small area.|8 weeks||||score on a scale||Standard Deviation|Mean
2526610|NCT03651479|Secondary|Video Boxing Analysis of Punching|Video Boxing Analysis (VBA) evaluation method was used to evaluate the goal-oriented performance analysis of upper extremity. For boxing analysis patients were videotaped while punching with their right side, punching with side left and punching bilaterally. Than the videotape were watched to analyze and the number of right unilateral punches in 1 minute, number of left unilateral punches in 1 minute and number of bilateral punches in 1 minute were recorded. This analysis were done for the quantitative assessment of punch number per minute (number of punch/minute). This measurement method is created and constructed by the authors of this study. Higher number of punches indicate better outcome on this analysis.|8 weeks||||repetitions per minute||Standard Deviation|Mean
2526611|NCT03651479|Secondary|Minnesota Manual Dexterity Test|Minnesota Manual Dexterity Test (MMDT) measures the speed of gross arm and hand movements (arm-hand dexterity) during rapid eye-hand coordination tasks. The MMDT involve five subtests:The Placing Test (1st item: taking the blocks with one hand and putting them in the holes on the board in a standardized order) and Two-hand Turning and Placing Test (5th item: taking the blocks with two hands and putting them in the holes on the board in a standardized order) were the two items selected for this study.The number of seconds it took to complete the task on each of the trials was recorded. The lower the score, the better the outcome.|8 weeks||||seconds||Standard Deviation|Mean
2526612|NCT03651479|Primary|Wolf Motor Function Test|Wolf Motor Function Test (WFMT) quantifies upper extremity motor ability through the use of timed and functional tasks. The widely used version of the WMFT consists of 17 items, items 7 and 14 are related to subject strength and the other 15 to subject functional ability during various tasks. Performances are scored using a 6-point functional ability scale and the less affected upper extremity followed by the most affected side. The total score, also referred to as Functional Ability score (WMFT-FAS), is the sum of the 15 items score (with a 6-point ordinal score from 0 to 5). The maximum total score is 75 and minimum is 0. Lower scores indicating lower functional levels.|8 weeks||||score on a scale||Standard Deviation|Mean
2526613|NCT03650842|Primary|Renal Regional Oxygen Saturation (rSO2)|Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the left posterior-lateral flank.|At the end of laparoscopy||||percentage of oxygen||Standard Deviation|Mean
2526614|NCT03650842|Primary|Renal Regional Oxygen Saturation (rSO2)|Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the left posterior-lateral flank.|At time of incision||||percentage of oxygen||Standard Deviation|Mean
2526615|NCT03650842|Primary|Cerebral Regional Oxygen Saturation (rSO2)|Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the forehead.|At the end of laparoscopy||||percentage of oxygen||Standard Deviation|Mean
2526616|NCT03650842|Primary|Cerebral Regional Oxygen Saturation (rSO2)|Near-infrared spectroscopy (NIRS model INVOS 5100; Covidien, Minneapolis, MN, USA) with sensors (Neonate SomaSensor® CNN; Covidien, Minneapolis, MN, USA) placed on the forehead.|At time of incision||||percentage of oxygen||Standard Deviation|Mean
2526617|NCT03649867|Primary|Participants Experience of the Survive & Thrive Course - Themes|"Total of 13 participants attended 30 minutes semi-structured interview which explored their experience of the Survive & Thrive course. The transcribed interviews were analysed using Interpretative Phenomenological Analysis (IPA). Superordinate themes captured by the interviews followed by respective sub-themes were:~Sense of connectedness, Sub-themes: I am not alone; Shared understanding; Safe environment/space~Journey towards recovery, Sub-themes: It gets harder before it gets better; Life changing experience; Sense of empowerment; Long way to go~Facing the facts & triggers, Sub-themes: Facing denial & triggers; Eye opening moments; Acceptance and greater understanding~Initial apprehension, Sub-themes: Sense of helplessness; Readiness for change; Fear of the unknown~Sense of being let down, Sub-themes: Challenging personalities; Repetitiveness of questionnaires; Need for additional support~The number of participants that fell into each theme are reported below."|30-45 minutes||||Participants|||Count of Participants
2526618|NCT03649750|Secondary|Number of Adverse Events(AEs) Experienced by Participants|Intensity determination Mild=AE does not limit usual activities;subject may experience slight discomfort Moderate=AE results in some limitation of usual activities;subject may experience significant discomfort Severe=AE results in an inability to carry out usual activities;subject may experience intolerable discomfort or pain Unassessable/Unclassifiable=Insufficient information to be able to make an assessment Conditional/Unclassified=Insufficient information to make an assessment at present(causality is conditional on additional information) Unrelated=No possibility that the AE was caused by study drug Unlikely=Slight but remote chance that the AE was caused by study drug but the balance of judgment is that it was most likely not due to the study drug Possible=Reasonable suspicion that the AE was caused by the study drug Probable=Most likely that the AE was caused by study drug Certain=The AE was definitely caused by study drug|Up to period 2 (8.3 days/200 hours)|"Pharmacokinetic Dataset~Investigational Medicinal Product(IMP)"|||Events|||Number
2526619|NCT03649750|Secondary|Relative Bioavailability (RF) of Guaifenesin|"Relative bioavailability for each formulation will be defined as:~(AUC0-inf Fasting ÷ AUC0-inf Fed) x (Fed dose ÷ Fasting dose)"|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)|Outcome involved analyzing data from both intervention groups (Fed and Fasting) in combination as per the provided formula, therefore, separate analysis for each intervention cannot be reported|||Percent bioavailability||Standard Deviation|Mean
2526786|NCT03634306|Secondary|Intra-abdominal Pressure|Maximum intra-abdominal pressure used measured in mmHg|End of procedure||||mmHg||Standard Deviation|Mean
2526620|NCT03649750|Secondary|Terminal Elimination Half-life (T½) of Guaifenesin|Terminal elimination half-life, calculated from the equation: thalf = In(2)/Kel.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)|Pharmacokinetic Dataset|||h||Standard Deviation|Mean
2526621|NCT03649750|Secondary|Terminal Elimination Rate Constant (Kel) of Guaifenesin|Elimination rate constant calculated from the slope of the terminal portion of the plasma profile calculated by least-squares regression of log (concentration) versus time.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)|Pharmacokinetic Dataset|||1/h||Standard Deviation|Mean
2526622|NCT03649750|Secondary|Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) of Guaifenesin|"The area under the analyte concentration versus time curve from time zero to infinity.~AUCinf = AUCt + Cp/Kel,~where Cp is the predicted analyte concentration at the time of the last measurable analyte concentration."|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)|Pharmacokinetic Dataset|||ng·h/ml||Standard Deviation|Mean
2526623|NCT03649750|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin|Time of the maximum measured analyte concentration over the sampling period.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)|Pharmacokinetic Dataset|||h||Standard Deviation|Mean
2526624|NCT03649750|Primary|Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Plasma Concentration (AUCt) of Guaifenesin|The area under the analyte concentration versus time curve, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear trapezoidal method.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)|Pharmacokinetic Dataset|||ng·h/ml||Standard Deviation|Mean
2526625|NCT03649750|Primary|Maximum Observed Plasma Concentration (Cmax) of Guaifenesin|Maximum measured analyte concentration over the sampling period.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, and 24 hours (Period 1 and 2)|"Pharmacokinetic (PK) Dataset are the Subjects from whom the observation/estimation of Cmax and AUC measures/parameters will be possible for two periods will be included in the PK dataset.~The PK dataset will be defined prior to the assay of samples."|||ng/ml||Standard Deviation|Mean
2526626|NCT03648983|Secondary|Percentage of Subjects With Complete Resolution of Signs of Enhanced Lymphedema|The Fisher's exact test will be used to compare between the enhanced vs. standard detection groups the percentage of subjects with complete resolution of signs and symptoms of LE following treatment with a compression garment. Logistic regression models will also be fit to the data to adjust for potential confounders.|During treatment (up to 34 months) plus 1 year post treatment|*** Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.***||||||
2526627|NCT03648983|Secondary|Severity of Enhanced Lymphedema|Severity of LE in terms of changes in arm circumference at the site of greatest difference and L-Dex change, will be compared between the enhanced versus standard detection groups with the Fisher's exact test. Adjustment for potential imbalances in patient characteristics will be accomplished by fitting logistic and Cox proportional hazards regression models.|During treatment (Up to 34 months)|*** Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.***||||||
2526628|NCT03648983|Primary|Rates of Enhanced Lymphedema Detection|"Rates of enhanced lymphedema detection will be compared between the enhanced versus standard detection groups with the Fisher's exact test. Adjustment for potential imbalances in patient characteristics will be accomplished by fitting logistic and Cox proportional hazards regression models.~*** Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.***"|During treatment (Up to 34 months)|*** Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.***||||||
2526629|NCT03648853|Primary|Photoplethysmography (PPG)|Change in the PPG signal in response to tetanic stimulus. A tetanic stimulus will cause vasoconstriction which can be recorded as a decrease in PPG AC/DC. The outcome measure is the maximum decrease in AC/DC from baseline. Maximum decrease happens typically in 30-60 seconds after the stimulus. Thus, data was collected immediately before (baseline) and for 2 min after the stimulus. After the stimulus AC/DC values return to baseline in a few minutes. Baseline AC/DC measures a relative state of blood vessel tone. In anesthetized patients the AC/DC values can range from close to 0 to above 10. The higher the value, the more vasodilated the subject is.|1-2 minutes||||arbitrary units||Standard Deviation|Mean
2526630|NCT03647046|Primary|Number of Participants With Normal Vision|Vision will be tested using the Basic Snellen Visual Acuity test and normal vision will be defined as 20/20.|30 minutes||||Participants|||Count of Participants
2526631|NCT03647033|Secondary|Change in Glaucoma Medications|change in number of topical glaucoma medications at 1 year post operation|1 year||||number of glaucoma medications||Standard Deviation|Mean
2526632|NCT03647033|Primary|Change in Intraocular Pressure Between Baseline and 1 Year|change in mean unmedicated intraocular pressure between baseline and 1 year|1 year|intraocular pressure of participants measured in mmHg|||mmHg||Standard Deviation|Mean
2526633|NCT03646656|Secondary|Gender Differences - Mean Contacts Per Buddy Pair|Quantitative and qualitative gender differences in feasibility and acceptance will be evaluated through quantitative differences in enrollment, retention and frequency of peer contacts, and qualitative comparison of participant-reported experiences with intervention content, peer and group interactions by gender.|12 weeks|consented participants by gender|||weeks||Full Range|Mean
2526634|NCT03646656|Secondary|Gender Differences-enrollment|Quantitative and qualitative gender differences in feasibility and acceptance will be evaluated through quantitative differences in enrollment, retention and frequency of peer contacts, and qualitative comparison of participant-reported experiences with intervention content, peer and group interactions by gender. Data are presented only for reciprocal peer partner group as this was pre-specified to compare outcomes between men and women in the reciprocal peer partner group. Thus, peer coaches are not described in this outcome.|12 weeks|participants by gender contacted by invitation letter for study participation|||Participants|||Count of Participants
2526635|NCT03646656|Secondary|Gender Differences - Retention|Quantitative and qualitative gender differences in feasibility and acceptance will be evaluated through quantitative differences in enrollment, retention and frequency of peer contacts, and qualitative comparison of participant-reported experiences with intervention content, peer and group interactions by gender. Data are presented only for reciprocal peer partner group as this was pre-specified to compare outcomes between men and women in the reciprocal peer partner group. Thus, peer coaches are not described in this outcome.|12 weeks||||Participants|||Count of Participants
2526636|NCT03646656|Primary|Acceptability - Weeks Contact With Peer Buddy|Acceptability of study based on successful peer buddy contacts per pair (not applicable to coaches)|12 weeks||||weeks||Full Range|Mean
2526637|NCT03646656|Primary|Acceptability|Acceptability of study based on successful peer buddy contacts per pair (not applicable to coaches) and participation in group sessions.|12 weeks|participants who attended at least 1 group session|||group sessions attended per participant||Full Range|Mean
2526638|NCT03646656|Primary|Feasibility Retention|Retention rates from consent to enrollment and from enrollment to completion of study.|12 weeks||||Participants|||Count of Participants
2526639|NCT03646656|Primary|Feasibility of Enrollment|Number of participants contacted, screened and enrolled in the pilot|12 weeks|Number of participants contacted for participation|||Participants|||Count of Participants
2526640|NCT03645811|Primary|The Situational-Continuous Anxiety Inventory|"The Situational Anxiety Scale was used for scoring anxiety. The Situational-Continuous Anxiety Inventory includes two separate scales with a total of 40 items. This study employed the Situational Anxiety Scale. The Situational Anxiety Scale consists of a total of 20 items. Its reliability coefficient varies between 0.83-0.96. The participants were expected to respond to the items according to their feelings and thoughts at that moment. In this study, the Cronbach's alpha value of the Situational Anxiety Scale was 0.92.~The items of the Situational Anxiety Scale are scored on a scale of 1-4 depending on the level at which the mentioned emotions or behaviors were experienced. The total score obtained from the scale can vary between 20 and 80. Higher scores indicate higher levels of anxiety."|Immediately after intervention completion, an average of 1 hours|This study was conducted with 90 volunteering students studying at the Faculty of Health Sciences, Department of Nursing, at a foundation university in Medipol University.|||score on a scale||Inter-Quartile Range|Median
2526641|NCT03645421|Secondary|Number of Patients With Antidrug Antibody (ADA) Response to MEDI0382|"The number of patients who were ADA positive at baseline and/or post-baseline are presented. Persistent positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at the last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.~+ve = positive"|Samples were collected predose on days 1, 13, 20 and 48, and 7 to 14 days after administration of last dose of IP.|The PK Analysis Set included all patients who received at least 1 dose of MEDI0382 and had at least 1 post-baseline MEDI0382 PK sample taken that was above the lower limit of quantification.|||Participants|||Count of Participants
2526642|NCT03645421|Secondary|Mean Trough Plasma Concentration (Ctrough) of MEDI0382 up to Day 48|To evaluate pharmacokinetics (PK), blood samples were collected predose and Ctrough of MEDI0382 was determined. Results are presented for Days 2, 5, 34 and 48.|Blood samples collected predose on Days 1 to 6, 13, 20, 34 and 48.|The PK Analysis Set included all patients who received at least 1 dose of MEDI0382 and had at least 1 post-baseline MEDI0382 PK sample taken that was above the lower limit of quantification. Patients with data available at each timepoint are presented.|||nanograms per millilitre||Geometric Coefficient of Variation|Geometric Mean
2526643|NCT03645421|Secondary|Mean Change From Baseline in the Percentage of Time in Hypoglycaemia Over 5 Days for 50 mcg Dose Level and 7 Days for Other Dose Levels|Hyp0glycaemia was defined as blood glucose <3 mmol/L or <54 mg/dL. Continuous glucose monitoring used a device fitted to the upper arm by trained study site staff to measure and record interstitial glucose levels every 15 minutes. Analysis was based on 24-hour readings defined as the first available time point with a valid continuous glucose monitoring glucose reading. The change in the percentage time in hypoglycaemia from the last day of baseline continuous glucose monitoring over 5 days for 50 mcg MEDI0382 and 7 days for each of the randomised dose levels (during titration) is presented, up to Day 47, per randomised group.|Baseline (Day -8 to -2) and Days 1 to 5, 6 to 12, 13 to 19 and 41 to 47.|The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. Patients with data available at each time point are presented.|||Percentage of time||Standard Deviation|Mean
2526644|NCT03645421|Secondary|Mean Change From Baseline in the Percentage of Time in Hyperglycaemia Over 5 Days for 50 mcg Dose Level and 7 Days for Other Dose Levels|Hyperglycaemia was defined as blood glucose >7.8 mmol/L or >140 mg/dL. Continuous glucose monitoring used a device fitted to the upper arm by trained study site staff to measure and record interstitial glucose levels every 15 minutes. Analysis was based on 24-hour readings defined as the first available time point with a valid continuous glucose monitoring glucose reading. The change in the percentage time in hyperglycaemia from the last day of baseline continuous glucose monitoring over 5 days for 50 mcg MEDI0382 and 7 days for each of the dose levels (during titration) is presented, up to Day 47, per randomised group.|Baseline (Day -8 to -2) and Days 1 to 5, 6 to 12, 13 to 19 and 41 to 47.|The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. Patients with data available at each time point are presented.|||Percentage of time||Standard Deviation|Mean
2526645|NCT03645421|Secondary|Mean Change From Baseline in the Percentage of Time in Hypoglycaemia Over 24 Hours at Days 5, 12, 19 and 47|Hypoglycaemia was defined as blood glucose <3 mmol/L or <54 mg/dL. Continuous glucose monitoring used a device fitted to the upper arm by trained study site staff to measure and record interstitial glucose levels every 15 minutes. Analysis was based on 24-hour readings defined as the first available time point with a valid continuous glucose monitoring glucose reading. The change in the percentage time in hypoglycaemia from the last day of baseline continuous glucose monitoring over 24 hours to the end of dosing at each dose level for the timepoints is presented.|Baseline (Day -8 to -2) and Days 5, 12, 19 and 47.|The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. Patients with data available at each time point are presented.|||Percentage of time||Standard Deviation|Mean
2526646|NCT03645421|Secondary|Mean Change From Baseline in the Percentage of Time in Hyperglycaemia Over 24 Hours at Days 5, 12, 19 and 47|Hyperglycaemia was defined as blood glucose >7.8 mmol/L or >140 mg/dL. Continuous glucose monitoring used a device fitted to the upper arm by trained study site staff to measure and record interstitial glucose levels every 15 minutes. Analysis was based on 24-hour readings defined as the first available time point with a valid continuous glucose monitoring glucose reading. The change in the percentage time in hyperglycaemia from the last day of baseline continuous glucose monitoring over 24 hours to the end of dosing at each dose level for the indicated timepoints is presented.|Baseline (Day -8 to -2) and Days 5, 12, 19 and 47.|The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. Patients with data available at each time point are presented.|||Percentage of time||Standard Deviation|Mean
2526647|NCT03645421|Secondary|Mean Change From Baseline in Fructosamine at Day 48|The mean change from baseline in fructosamine at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, the last on-treatment measurement, regardless of rescue medication, was used (LOCF).|Baseline (Day -1) and Day 48 (predose).|The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. Patients with data available are presented.|||millimoles per litre (mmol/L)||95% Confidence Interval|Least Squares Mean
2526648|NCT03645421|Secondary|Mean Change From Baseline in Fasting Plasma Glucose at Day 48|The mean change from baseline in fasting plasma glucose at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, or for patients who did not have a measurement taken on Day 48, the last post-baseline measurement, regardless of rescue medication, was used (LOCF).|Baseline (Day -1) and Day 48 (predose).|The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. Patients with data available are presented.|||milligrams per decilitre (mg/dL)||95% Confidence Interval|Least Squares Mean
2526649|NCT03645421|Secondary|Mean Change From Baseline in HbA1c at Day 48|The mean change from baseline in HbA1c at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, or for patients who did not have a measurement taken on Day 48, the last post-baseline measurement, regardless of rescue medication, was used (LOCF).|Baseline (Day -1) and Day 48 (predose).|The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. Patients with data available are presented.|||Percent glycated haemoglobin||95% Confidence Interval|Least Squares Mean
2526650|NCT03645421|Primary|Number of Patients Who Experienced Adverse Events (AEs)|AEs were collected from Day 1 of treatment up to 14 days after the last dose of IP. Serious AEs (SAEs) were collected from signing of informed consent. The numbers of patients who experienced any AE, any SAE (including events with an outcome of death), and any AE leading to discontinuation of IP are presented.|Day 1 up to 14 days after the last dose of IP (approximately 9 weeks).|The Safety Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to the treatment received.|||Participants|||Count of Participants
2526651|NCT03645421|Primary|Mean Change From Baseline in Heart Rate Measured by Electrocardiogram (ECG) at Day 48.|Digital ECGs were taken at baseline and predose and postdose on Days 1, 6, 13, 20 and 48. The mean change from baseline is presented.|Baseline (Day -1) and Days 1, 6, 13, 20 and 48: predose and 6 hours (+/-15 minutes) postdose.|The Safety Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to the treatment received. Patients with data available at each timepoint are presented.|||beats/minute||Standard Deviation|Mean
2526652|NCT03645421|Primary|Mean Percentage Change From Baseline in Body Weight at Day 48|The mean percentage change from baseline in body weight at Day 48 was analysed using an ANCOVA model with treatment group as a factor and baseline as a covariate. For patients who prematurely discontinued IP, the last on-treatment measurement, regardless of rescue medication, was used (last observation carried forward [LOCF]).|Baseline (Day -1) and Day 48.|The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. Patients with data available are presented.|||Percentage change||95% Confidence Interval|Least Squares Mean
2526653|NCT03645421|Primary|Mean Percentage Change From Baseline in Glucose Area Under the Plasma Concentration Curve (AUC[0-4h]) as Measured by a Standardised Mixed-Meal Test (MMT) at Day 48|The MMT was conducted following a minimum 8-hour fast. Blood samples for glucose monitoring were taken 15 minutes before the patient consumed a standardised meal, and samples were taken at intervals after the meal, up to 4 hours. The MMT glucose AUC(0-4h) was calculated using a trapezoidal method, and the mean percentage change from baseline at Day 48 was analysed using an analysis of covariance (ANCOVA) model with treatment group as a factor and baseline as a covariate.|Baseline (Day -1) and Day 48: 15 minutes before standardised meal, and then at 15, 30, 45, 60, 90, 120, 180 and 240 minutes (+/-5 minutes) after consumption of the standardised meal.|The Full Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to their randomised treatment group. MMTs were not conducted on patients who prematurely discontinued IP.|||Percentage change||95% Confidence Interval|Least Squares Mean
2526654|NCT03645421|Primary|Mean Change From Baseline in 24-Hour Systolic and Diastolic Blood Pressure (BP) at Days 20 and 48|Twenty four-hour BP was determined using an ABPM device, and the mean change from baseline in the 24-hour systolic BP and 24-hour diastolic BP are presented for Days 20 and 48.|Baseline (Day -1) and Days 20 and 48.|The Safety Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to the treatment received. Patients with data available at each timepoint are presented.|||millimetres of mercury||Standard Deviation|Mean
2526655|NCT03645421|Primary|Mean Change From Baseline in 24-Hour Heart Rate at Days 20 and 48|Twenty four-hour heart rate was determined using an ambulatory blood pressure monitoring (ABPM) device, and the mean change from baseline in the 24-hour heart rate is presented for Days 20 and 48.|Baseline (Day -1) and Days 20 and 48.|The Safety Analysis Set included all randomised patients who received at least 1 dose of IP, analysed according to the treatment received. Patients with data available at each timepoint are presented.|||beats/minute||Standard Deviation|Mean
2526656|NCT03644212|Primary|AMH Levels in Women With PCOS|AMH measured by serum analysis|8 weeks after completing vitamin D treatment||||ng/mL||Standard Deviation|Mean
2526657|NCT03644108|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs)|"Intensity was determined by the Investigator. For symptomatic AEs the following definitions were applied.~Mild = AE did not limit usual activities; subject may have experienced slight discomfort.~Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort.~Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain.~Relationship to Investigational Medicinal Products (IMP)~Unlikely = Slight, but remote, chance that AE was caused by IMP. Possible = Reasonable suspicion that the AE was caused by IMP. Probable = Most likely that AE was caused by IMP."|Up to Day 2||||Participants|||Count of Participants
2526658|NCT03644108|Primary|Apparent Terminal Elimination Half-life (t1/2) of Guaifenesin|Apparent terminal elimination half-life (t1/2) calculated as ln(2)/Kel.|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2||||hr||Standard Deviation|Mean
2526659|NCT03644108|Primary|Apparent Terminal Elimination Rate Constant (Kel) of Guaifenesin|Apparent terminal elimination rate constant (Kel) calculated by linear regression of the terminal linear portion of the log concentration-time curve.|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2||||1/hr||Standard Deviation|Mean
2526660|NCT03644108|Primary|Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin|Ratio of AUC(0-t) to AUC(0-inf), referred to as AUCR. [AUCR = AUC(0-t) / AUC(0-inf)]|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2||||Ratio||Standard Deviation|Mean
2526661|NCT03644108|Primary|Time to Maximum Observed Concentration (Tmax) of Guaifenesin|Pharmacokinetic Parameter tmax (Time of the maximum observed drug concentration).|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2||||hr||Full Range|Median
2526662|NCT03644108|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin|Area under the drug concentration-time curve from time zero to infinity, AUC(0-inf) = AUC(0-t) + Ct/Kel, where Kel is the terminal elimination rate constant.|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2||||ng∙hr/mL||Geometric Coefficient of Variation|Geometric Mean
2526663|NCT03644108|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin|Area under the drug concentration-time curve calculated using linear trapezoidal summation from time zero to time t, where t is the time of the last measurable concentration (Ct).|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2||||ng∙hr/mL||Geometric Coefficient of Variation|Geometric Mean
2526664|NCT03644108|Primary|Maximum Observed Plasma Concentration (Cmax) of Guaifenesin|Pharmacokinetic Parameters Cmax (Maximum observed drug concentration)|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2|Data Sets Analyzed as all 30 subjects were included in the guaifenesin concentration tables and the calculation of guaifenesin Pharmacokinetic (PK) parameters.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2526665|NCT03644095|Secondary|Number of Adverse Events (AE) of Participants|Mild = AE does not limit usual activities;subject may experience slight discomfort; Moderate = AE results in some limitation of usual activities; subject may experience significant discomfort; Severe = AE results in an inability to carry out usual activities; Probable = Most likely that the AE was caused by study drug; Possible = Reasonable suspicion that the AE was caused by the study drug; Unlikely = Slight but remote chance that the AE was caused by study drug but the balance of judgment is that it was most likely not due to the study drug.|Upto Day 2||||Events|||Number
2526666|NCT03644095|Primary|Apparent Terminal Elimination Half-life (t1/2) of Guaifenesin|Apparent first-order terminal elimination half-life, calculated as ln(2)/kel.|0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2|PK Data Set|||hr||Standard Deviation|Mean
2526667|NCT03644095|Primary|Apparent Terminal Elimination Rate Constant (Kel) of Guaifenesin|Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares (LS) regression analysis using the maximum number of points (e.g. 3 or more non-zero plasma concentrations) in the terminal log-linear phase.|0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2|PK Data Sets|||1/hr||Standard Deviation|Mean
2526668|NCT03644095|Primary|Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin|Pharmacokinetic Parameter AUCR is the ratio of AUC(0-t) to AUC(0-inf). AUCR = AUC(0-t) / AUC(0-inf)|0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2|PK Data Set|||Ratio||Standard Deviation|Mean
2526669|NCT03644095|Primary|Time to Maximum Observed Concentration (Tmax) of Guaifenesin|Pharmacokinetic Parameter (Tmax) Time of the maximum observed plasma concentration.|0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2|PK Data Set|||hr||Standard Deviation|Mean
2526670|NCT03644095|Primary|Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin|Area under the plasma concentration versus time curve from time 0 to infinity, calculated as AUC 0-t + C last/kel, where C last is the last measurable concentration and kel is the apparent first-order terminal elimination rate constant.|0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2|PK Data Set|||ng*hr/mL||Standard Deviation|Mean
2526671|NCT03644095|Primary|Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin|Area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration, as calculated by the linear trapezoidal method.|0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2|PK Data Set|||ng*hr/mL||Standard Deviation|Mean
2528110|NCT03527966|Secondary|Fusion Rates, Evaluated Via CT Scan I Year Postoperatively||1 year post surgery|No patient returned for their 1 year post op scan||||||
2526672|NCT03644095|Primary|Maximum Observed Plasma Concentration (Cmax) of Guaifenesin|Pharmacokinetic Parameter (Cmax) Maximum observed plasma concentration.|0 (pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16 and 24 hours (post-dose) on Day 1 and 2|The Pharmacokinetic (PK) parameters were calculated from individual plasma concentration-time data (using actual blood draw times).|||ng/mL||Standard Deviation|Mean
2526673|NCT03643575|Secondary|Number of Participants With Adverse Events (AEs)|"Intensity was determined by the Investigator. For symptomatic Adverse Events (AEs) the following definitions were applied.~Mild = AE did not limit usual activities; subject may have experienced slight discomfort.~Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort.~Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain.~Relationship to Investigational Medicinal Products (IMP)~Unlikely = Slight, but remote, chance that AE was caused by IMP. Possible = Reasonable suspicion that the AE was caused by IMP. Probable = Most likely that AE was caused by IMP."|Up to day 2 (Period 3)|PK analyses|||participants|||Number
2526674|NCT03643575|Primary|Peak Plasma Concentrations at Steady State (Swing) of Guaifenesin|Pharmacokinetic Parameter Swing is Calculated as (Cmax,ss - Cmin,ss) / Cmin,ss.|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours|PK analyses|||Percentage||Standard Deviation|Mean
2526675|NCT03643575|Primary|Degree of Fluctuation (DF) of Guaifenesin|DF is the Degree of Fluctuation Index, calculated as (Cmax,ss - Cmin,ss) / Cav.|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours|PK analyses|||Percent fluctuation in concentration||Standard Deviation|Mean
2526676|NCT03643575|Primary|Accumulation Index (AI) of Guaifenesin|AI is the accumulation index, calculated as AUC(8-12) / AUC(0-4).|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4 hours and 8, 8.5, 8.75, 9, 9.5, 10, 11, 12 hours|PK analyses|||Ratio||Standard Deviation|Mean
2526677|NCT03643575|Primary|Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin|Pharmacokinetic Parameter AUCR is the Ratio of AUC(0-t) to AUC(0-inf). AUCR = AUC(0-t) / AUC(0-inf).|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours|PK analyses|||Ratio||Standard Deviation|Mean
2526678|NCT03643575|Primary|Area Under Plasma Concentration Versus Time Curve From Time 8 to 12 Hours [AUC(8-12)] of Guaifenesin|AUC(8-12) is the area under the plasma concentration versus time curve from time 8 to 12 hours postdose (relative to first dose), as calculated by the linear trapezoidal method.|8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hours|PK analyses|||ng*hr/mL||Standard Deviation|Mean
2526679|NCT03643575|Primary|Area Under Plasma Concentration Versus Time Curve From 0 to 4 Hours [AUC(0-4)] of Guaifenesin|AUC(0-4) is the area under the plasma concentration versus time curve from time 0 to 4 hours post dose (relative to first dose), as calculated by the linear trapezoidal method.|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3 and 4 hours|PK analyses|||ng*hr/mL||Standard Deviation|Mean
2526680|NCT03643575|Primary|Area Under Plasma Concentration Versus Time Curve From Time 0 to Infinity [AUC(0-inf)] of Guaifenesin|AUC(0-inf) is the area under the plasma concentration versus time curve from time 0 to infinity, calculated as AUC(0-t) + Ct/Kel, where Ct was the last measurable concentration and Kel is the apparent first-order terminal elimination rate constant.|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours|PK analyses|||ng*hr/mL||Standard Deviation|Mean
2526681|NCT03643575|Primary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration [AUC(0-t)] of Guaifenesin|AUC(0-t) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration, as calculated by the linear trapezoidal method.|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours|PK analyses|||ng*hr/mL||Standard Deviation|Mean
2526682|NCT03643575|Primary|Apparent First-order Terminal Elimination Rate Constant (Kel) of Guaifenesin|Kel is the apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares (LS) regression analysis using the maximum number of points (e.g., 3 or more non-zero plasma concentrations) in the terminal log-linear phase.|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours|PK analyses|||1/hr||Standard Deviation|Mean
2526683|NCT03643575|Primary|Apparent First-order Terminal Elimination Half-life (T1/2) of Guaifenesin|T1/2 is the apparent first-order terminal elimination half-life, calculated as ln(2)/Kel.|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours|PK analyses|||hr||Standard Deviation|Mean
2526684|NCT03643575|Primary|Time to Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of Guaifenesin Following the Third Dose|Pharmacokinetic Parameter Tmax, ss is the time of the maximum observed plasma concentration following the third dose.|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours|PK analyses|||hr||Standard Deviation|Mean
2526685|NCT03643575|Primary|Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin|Pharmacokinetic Parameter Tmax is the time of the maximum observed plasma concentration.|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours|PK analyses|||hr||Standard Deviation|Mean
2526686|NCT03643575|Primary|Average Plasma Concentration (Cav) of Guaifenesin Following the Third Dose|"Average plasma concentration (Cav) following the third dose, calculated as AUC(8-12) divided by the dosing interval, 4.~Cav is calculated as AUC(8-12) / dosing interval, 4"|8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hours|PK analyses|||ng/mL||Standard Deviation|Mean
2526687|NCT03643575|Primary|Observed Plasma Concentration at the End of Dosing Interval at Steady State (Cmin,ss) of Guaifenesin Following the Third Dose|Observed plasma concentration at the end of the dosing interval following the third dose (that is, 4 hours following the third dose).|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours|PK analyses|||ng/mL||Standard Deviation|Mean
2526688|NCT03643575|Primary|Maximum Measured Plasma Concentration at Steady State (Cmax,ss) of Guaifenesin Following the Third Dose|Pharmacokinetic Parameter Cmax,ss is the Maximum observed plasma concentration following the third dose.|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours|PK analyses|||ng/mL||Standard Deviation|Mean
2526689|NCT03643575|Primary|Maximum Observed Plasma Concentration (Cmax) of Guaifenesin|Pharmacokinetic Parameter Cmax is the Maximum observed plasma concentration.|0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours|Pharmacokinetic (PK) analyses were performed on the available data of the subjects that completed at least 1 period.|||ng/mL||Standard Deviation|Mean
2526690|NCT03643159|Secondary|Difference In The Number Of Participants With At Least 80% Proportion Of Days Covered (PDC) (With Antipsychotic Medication) For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To Day 180|This outcome measure describes the difference in the number of participants with at least 80% PDC (with antipsychotic medication) between those using Abilify MyCite and those receiving treatment as usual (the virtual matched controls). Due to early study termination, efficacy data were not collected.|Baseline through Day 180|Efficacy Analysis: All participants who received at least 1 dose of Abilify MyCite or who were a virtual matched control and had efficacy data. Both participants were excluded from efficacy analysis because they discontinued study therapy early. In addition, efficacy data were not collected due to early study termination.||||||
2526691|NCT03643159|Primary|Difference In The Number Of Participants With All-cause Hospitalizations For Participants Using Abilify MyCite Versus Virtual Matched Controls From Baseline To Day 180|This outcome measure describes the difference in all-cause hospitalizations (that is hospitalizations for any reason) between the number of participants using Abilify MyCite and those receiving treatment as usual (the virtual matched controls). Due to early study termination, efficacy data were not collected.|Baseline through Day 180|Efficacy Analysis: All participants who received at least 1 dose of Abilify MyCite or who were a virtual matched control and had efficacy data. Both participants were excluded from efficacy analysis because they discontinued study therapy early. In addition, efficacy data were not collected due to early study termination.||||||
2526692|NCT03642873|Secondary|Number of Adverse Events(AEs) Experienced by Participants|"Intensity was determined by the Investigator. For symptomatic AEs the following definitions were applied.~Mild = AE did not limit usual activities; subject may have experienced slight discomfort.~Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort.~Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/ pain.~Relationship to Investigational Medicinal Products (IMP) Unlikely = Slight, but remote, chance that AE was caused by IMP. Possible = Reasonable suspicion that the AE was caused by IMP. Probable = Most likely that AE was caused by IMP."|Upto Day 17|Pharmacokinetic (PK) Data Sets|||Events|||Number
2526693|NCT03642873|Primary|Apparent Terminal Elimination Half-life (T1/2) of Guaifenesin|Apparent first-order terminal elimination half-life was calculated as 0.693/Kel.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose|Pharmacokinetic (PK) Data Sets|||hr||Standard Deviation|Mean
2526694|NCT03642873|Primary|Time to Maximum Observed Concentration (Tmax) of Guaifenesin|Pharmacokinetic Parameter (Tmax) Time of the maximum measured plasma concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose|Pharmacokinetic (PK) Data Sets|||hr||Standard Deviation|Mean
2526695|NCT03642873|Primary|Apparent Terminal Elimination Rate Constant (Kel) of Guaifenesin|Apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the maximum number of points in the terminal log-linear phase.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose|Pharmacokinetic (PK) Data Sets|||1/hr||Standard Deviation|Mean
2526696|NCT03642873|Primary|Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin|The area under the plasma concentration versus time curve from time 0 to infinity, calculated as AUC(0-t) + Ct/ Kel, where Ct is the last measurable concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose|Pharmacokinetic (PK) Data Sets|||ng*hr/mL||Standard Deviation|Mean
2526697|NCT03642873|Primary|Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin|Pharmacokinetic Parameter AUC(0-t) The area under the plasma concentration versus time curve from time 0 to time of the last measurable concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose|Pharmacokinetic (PK) Data Sets|||ng*hr/mL||Standard Deviation|Mean
2526698|NCT03642873|Primary|Maximum Observed Plasma Concentration (Cmax) of Guaifenesin|Pharmacokinetic Parameter Cmax (Maximum measured plasma concentration)|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 8.5, 9, 9.5, 10, 11, 13, 16, 20, 24, and 26 hours Post dose|Pharmacokinetic (PK) Data Sets included all the 24 subjects for analysis.|||ng/mL||Standard Deviation|Mean
2526699|NCT03642262|Secondary|Number of Adverse Events(AEs) Experienced by Participants|Intensity determination Mild=AE does not limit usual activities; subject may experience slight discomfort Moderate=AE results in some limitation of usual activities;subject may experience significant discomfort Severe=AE results in an inability to carry out usual activities; subject may experience intolerable discomfort or pain Unassessable/Unclassifiable=Insufficient information to be able to make an assessment Conditional/Unclassified=Insufficient information to make an assessment at present (causality is conditional on additional information) Unrelated=No possibility that the AE was caused by study drug Unlikely=Slight, but remote, chance that the AE was caused by study drug, but the balance of judgment is that it was most likely not due to the study drug Possible=Reasonable suspicion that the AE was caused by the study drug Probable=Most likely that the AE was caused by study drug Certain=The AE was definitely caused by study drug Investigational Medicinal Product (IMP)|Up to period 2 (8.3 days/200 hours)|Safety population|||Events|||Number
2526700|NCT03642262|Secondary|Relative Bioavailability (RF) of Guaifenesin|RF is measured by (AUCinf ER / AUCinf IR) x (ER dose / IR dose)|0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours|Outcome involved analyzing data from both intervention groups (ER and IR) in combination as per the provided formula, therefore, separate analysis for each intervention cannot be reported|||ng·h/ml||Standard Deviation|Mean
2526701|NCT03642262|Secondary|Terminal Elimination Half-life (T½) of Guaifenesin|Terminal elimination half-life, calculated from the equation: T½ = In(2)/Kel.|0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours|PK Dataset|||h||Standard Deviation|Mean
2526702|NCT03642262|Secondary|Terminal Elimination Rate Constant (Kel) of Guaifenesin|Elimination rate constant calculated from the slope of the terminal portion of the plasma profile calculated by least squares regression of log (concentration) versus time|0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours|PK Dataset|||1/h||Standard Deviation|Mean
2526703|NCT03642262|Secondary|Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) of Guaifenesin|AUCinf = AUCt + Cp/Kel, where Cp is the predicted analyte concentration at the time of the last measurable analyte concentration.|0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours|PK Dataset|||ng·h/ml||Standard Deviation|Mean
2526704|NCT03642262|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin|Time of the maximum measured analyte concentration over the sampling period.|0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours|PK Dataset|||hr||Standard Deviation|Mean
2526705|NCT03642262|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Guaifenesin|The area under the analyte concentration versus time curve, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear trapezoidal method.|0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours|PK Dataset|||ng·h/ml||Standard Deviation|Mean
2526706|NCT03642262|Primary|Maximum Observed Plasma Concentration (Cmax) of Guaifenesin|Maximum measured analyte concentration over the sampling period.|0 (pre-dose) ,0.25,0.5, 0.75, 1,1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14, 16, 20 and 24 hours|Pharmacokinetic (PK) Parameter Set Population includes all subjects from the PK dataset with evaluable PK parameters for each treatment period.|||ng/ml||Standard Deviation|Mean
2526707|NCT03641508|Primary|Number of Participants With no Symptoms of Trigger Finger|"Number of participants with no symptoms of trigger finger 1 year after the initial encounter for both groups. Outcomes were determined clinically:~The Quinnell grading system was used for objectively evaluating the trigger finger. This grading system is a scale of 0-4 for severity of triggering with 0 being no triggering."|1 year||||Participants|||Count of Participants
2526708|NCT03641508|Primary|Number of Participants With no Symptoms of Trigger Finger|"Number of participants with no symptoms of trigger finger 6 months after the initial encounter for both groups. Outcomes were determined clinically:~The Quinnell grading system was used for objectively evaluating the trigger finger. This grading system is a scale of 0-4 for severity of triggering with 0 being no triggering."|6 months||||Participants|||Count of Participants
2526709|NCT03641508|Primary|Number of Participants With no Symptoms of Trigger Finger|"Number of participants with no symptoms of trigger finger 6 weeks after the initial encounter for both groups. Outcomes were determined clinically:~The Quinnell grading system was used for objectively evaluating the trigger finger. This grading system is a scale of 0-4 for severity of triggering with 0 being no triggering."|6 weeks||||Participants|||Count of Participants
2526710|NCT03640832|Secondary|Number of Participants With a Unit Change of >1 in Signs and Symptoms of Ocular Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use|Participants were instructed to self-assess any sensations of ocular discomfort for redness, dryness, stinging/burning and itching on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Participant self-assessment of ocular irritation total score = redness + dryness + itching + stinging/burning. Total possible score range is 0 to 12 (higher value indicated more ocular irritation). Change from baseline at 1-2 hours post first use = total score at 1 to 2 hours minus total score at baseline. Similarly, change from baseline for 21 days of product use = total score at Day 21 minus total score at baseline. Participants with a change of > 1 in total score of ocular irritation from baseline to 1-2 hours post first product use and Day 21 days of product use, are reported in this outcome measure.|Baseline, 1-2 hours post first use, Day 21|The Safety Population included all participants who received at least 1 dose of the study product (test or reference product).|||Participants|||Count of Participants
2526711|NCT03640832|Secondary|Number of Participants With a Unit Change of >1 in Signs and Symptoms of Cutaneous Irritation (Self-assessment) From Baseline to 1 to 2 Hours Post First Product Use and 21 Days of Product Use|Participants were instructed to self-assess any sensations of cutaneous discomfort for redness, dryness, stinging/burning, itching and tightness on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Participant self-assessment of cutaneous irritation total score = redness + dryness + itching + stinging/burning + tightness. Total possible score range is 0 to 15 (higher value indicated more cutaneous irritation). Change from baseline at 1-2 hours post first use = total score at 1 to 2 hours minus total score at baseline. Similarly, change from baseline for 21 days of product use = total score at Day 21 minus total score at baseline. Participants with a unit change of >1 in total score of cutaneous irritation from baseline to 1-2 hours post first product use and 21 days of product use, are reported in this outcome measure.|Baseline, 1-2 hours post first use, Day 21|The Safety Population included all participants who received at least 1 dose of the study product (test or reference product).|||Participants|||Count of Participants
2526712|NCT03640832|Secondary|Number of Participants With a Unit Change of >1 in Signs and Symptoms of Ocular Irritation Total Scores From Baseline to 21 Days of Product Use|A qualified ophthalmologist visually assessed the signs and symptoms of ocular irritation for ocular eczema of the eyelid, conjunctivitis, follicles and chemosis conjunctivae on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Ocular irritation total score = ocular score of eczema of the eyelid + ocular score of conjunctivitis + ocular score of follicles + ocular score of chemosis conjunctivae. Total possible score range is 0 to 12 (higher value indicated more ocular irritation). Change from baseline for 21 days of product use = total score at Day 21 minus total score at baseline. Participants with a unit change of > 1 in total score of ocular irritation from baseline to 21 days of product use, are reported in this outcome measure.|Baseline and Day 21|The Safety Population included all participants who received at least 1 dose of the study product (test or reference product).|||Participants|||Count of Participants
2526787|NCT03634306|Secondary|Operative Procedure Disruption|Count of the number of times the operative procedure is interrupted or delayed due to clearing smoke|Intraoperative||||Count of pauses for smoke clearing||Standard Deviation|Mean
2526713|NCT03640832|Primary|Number of Participants With a Unit Change of Greater Than (>) 1 in Signs and Symptoms of Cutaneous Irritation Total Scores From Baseline to 21 Days of Product Use|A qualified dermatologist visually assessed the signs and symptoms of cutaneous irritation for dermal erythema, dryness, scaling, and edema on a scale with a score range of 0 to 3, where 0=none, 0.5=very slight, 1=slight, 2=moderate, 3=severe. Cutaneous irritation total score = dermal score of erythema + dermal score of dryness + dermal score of scaling + dermal score of edema. Total possible score range is 0 to 12 (higher value indicated more cutaneous irritation). Change from baseline for 21 days of product use = total score at Day 21 minus total score at baseline. Participants with a unit change of greater than (>) 1 in total score (TS) of cutaneous irritation from baseline to 21 days of product use, are reported in this outcome measure.|Baseline and Day 21|The Safety Population included all participants who received at least 1 dose of the study product (test or reference product).|||Participants|||Count of Participants
2526714|NCT03640559|Primary|Number of Participants With Adverse Events (AEs)|"Evaluation of safety of the study drugs Seroguard and the Placebo will be performed for all the study subjects at Visits 1-11, based on account of parameter:~Vital signs (body temperature, BP, HR, RR)~Laboratory investigations:~Blood chemistry - total protein, glucose, ALT, AST, total bilirubin, alkaline phosphatase, amylase, creatinine~Complete blood count - RBC, WBC, platelet count, hemoglobin, hematocrit, WBC differential, ESR~Coagulogram - coagulation time, international normalized ratio (INR), thrombin time, activated partial thromboplastin time (APTT)~Urinalysis - color, transparency, pH, specific gravity, protein, glucose, WBC, RBC, bacteria, casts, salts~12-channel ECG data - heart rate [HR], PR, QRS, QT intervals and calculated QTc interval~USG data~Incidence of adverse reactions~Incidence of serious adverse reactions"|28 days||||Participants|||Count of Participants
2526715|NCT03640052|Secondary|Collapsibility of the Upper Airway: VActive (L/Min)|VActive: ventilation when ventilatory drive is high and pharyngeal dilator muscles are relatively active.|1 night||||Liters/minute||Standard Error|Mean
2526716|NCT03640052|Primary|Apnea Hypopnea Index (AHI, Average Number of Events for Every Hour of Sleep)|Based on previous studies the investigators anticipate that active comparators will reduce AHI more effectively in subjects with moderate sleep apnea and low-to-moderate collapsibility (Vpassive >50% of eupneic values). Higher AHI indicates more severe OSA, usually ranging between 10 to 110 events/hour.|1 night||||events/hour of sleep||Standard Error|Mean
2526717|NCT03639675|Secondary|Percentage of Participants Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Week 1|"NVI Grade: 0=No iris neovascularization; 1=Fine surface neovascularization of the pupillary zone of the iris involving less than two quadrants; 2=Surface neovascularization of the pupillary zone of the iris involving more than two quadrants; 3=In addition to neovascularization of the pupillary zone, neovascularization of the ciliary zone of the iris and/or ectropion uveae involving one to three quadrants; 4=In addition to neovascularization of the pupillary zone, neovascularization of the ciliary zone of the iris and/or ectropion uveae involving more than three quadrants. The change in NVI grades categorized to Improved means improvement by at least one grade from baseline."|Baseline and week 1||||Participants|||Count of Participants
2526718|NCT03639675|Primary|Change in Intraocular Pressure (IOP) From Baseline to Week 1|The primary efficacy analysis was on the changes in IOP from baseline to Week 1 (LOCF).|Baseline and week 1||||mmHg||Standard Deviation|Mean
2526719|NCT03638908|Other Pre-specified|Clinician Global Impression of Change (CGI-change)|"CGI-change questionnaire will be completed for global assessment of severity. This questionnaire is categorical and measures outcome from very much better being best outcome to very much worse being the worst outcome"|Weeks 12 and 24|analysis was not done as study primary endpoint was not met- since primary endpoint was not met, no further analyses were completed||||||
2526720|NCT03638908|Other Pre-specified|Short Form 36|Patient reported outcome will also be assessed using SF-36 completed at baseline, Week 12 and Week 24. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health|baseline, Week 12 and Week 24.|analysis was not done as study primary endpoint was not met- since primary endpoint was not met, no further analyses were completed||||||
2526721|NCT03638908|Other Pre-specified|Clinician Global Impression of Severity - Symptoms (CGIS)|"Global assessment of severity will be determined using Clinician global impression of severity - symptoms (CGIS). This questionnaire is categorical and measures outcome from none being best outcome to severe being the worst outcome"|Week 12 and Week 24.|analysis was not done as study primary endpoint was not met- since primary endpoint was not met, no further analyses were completed||||||
2526722|NCT03638908|Other Pre-specified|Patient Global Impression of Severity - Symptoms (PGIS)|"PGIS questionnaire will be administered for global assessment of severity. This questionnaire is categorical and measures outcome from none being best outcome to severe being the worst outcome"|baseline|analysis was not done as study primary endpoint was not met- since primary endpoint was not met, no further analyses were completed||||||
2526723|NCT03638908|Other Pre-specified|Quick Inventory of Depressive Symptomatology|Patient reported outcome will be assessed using the Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-SR16) completed at baseline, week 12 and Week 24; baseline and week 24 reported. Each question is scored from minimum of 0 to a maximum of 3; total score ranges from 0 to 42. With zero being better outcome and 42 being severe outcome|baseline and Week 24.|7 subjects of the total enrolled were included in the descriptive analysis. 1 subject did not complete the study|||score on a scale||Standard Deviation|Mean
2526724|NCT03638908|Other Pre-specified|Functional Class|Functional class will be measured using the WHO functional class assessment. This is graded from WHO FC I to FC IV. Assessment will be completed by an investigator on the study at every visit.|baseline and 24|analysis was not done as study primary endpoint was not met- since primary endpoint was not met, no further analyses were completed||||||
2526725|NCT03638908|Other Pre-specified|Exercise Capacity|Exercise capacity will be measure using the 6-minute walk test. Data collected at baseline and 24 were analyzed. The test will follow the ATS guidelines for 6MWT at all time.|baseline and 24|6 out of total enrolled had complete data for analysis|||meters||Standard Deviation|Mean
2526726|NCT03638908|Other Pre-specified|Markers of Platelets and Endothelial Activation in PAH.|About 20ml blood will be obtained for plasma and serum at Baseline and Week 24. This will be placed in a red-top tube (serum, at least 1 ml) and blue-top tube. For the plasma tests, a plasma volume of 750 microL is required. Samples will be sent together, as a batch of 50 is required, on dry ice via overnight courier. Plasma will be obtained by drawing blood into a blue-top citrated tube, inverting the tube 6 times, and then centrifuging at 2000g for 10 minutes. The platelet poor plasma will be drawn off, and then re-centrifuged for 10 minutes before freezing.|Baseline and Week 24|unable to analyze outcome as this sub-study was dependent on obtaining additional funding- samples were collected but not processed to provide result||||||
2526727|NCT03638908|Secondary|5-HIAA (HYDROXYINDOLE ACETIC ACID) Level|"Urine for spot urine 5-HIAA will be collected at baseline and Week 24. Subjects will be on diet restriction 72 hours prior to urine collection. Sample will be the first morning urine on the visit day. Sample will be brought to site and then sent to affiliate outside laboratory for processing. 5HIAA results are expressed as a ratio to creatinine excretion in the unit mg/g creatinine Change 5-HIAA is derived by getting the difference between baseline and week 24 5HIAA results (Week 24 minus Baseline). mean is then computed by getting the average of the change"|Baseline and Week 24|unable to adequately analyze outcome as there were several missing data- values provided below are not meaningful.|||mg/g CRT||Standard Deviation|Mean
2526728|NCT03638908|Primary|Pulmonary Vascular Resistance (PVR)|Change in PVR between baseline and follow-up will be utilized. PVR is calculated as [(Pulmonary Artery mean - wedge) / Fick Cardiac Output]. Fick CO will be used in computing PVR over thermodilution because Fick appears to have greater precision (but not accuracy). The calculation of PVR above is measured in woods unit. Change is derived by getting the difference between baseline and week 24 PVR (Week 24 minus Baseline). mean is then computed by getting the average of the change|Baseline and Week 24|6 out of the 8 subjects enrolled had complete- baseline and week 24- data for analysis|||woods unit||Standard Deviation|Mean
2526729|NCT03638635|Secondary|Hospitalization Costs|Total hospitalization costs per patient per this surgical encounter|From date of this surgical admission to date of this surgical discharge (usually up to 4 days after surgery).|Cost data was intended to be collected through the finance department at the end of the study. However, the study was terminated prematurely, so cost data is not able to be obtained.||||||
2526730|NCT03638635|Secondary|Mortality|Patient death after surgery|Within 30 days of surgery|Mortality data was going to be collected from chart review. However, the study was prematurely terminated before this data could be collected.||||||
2526731|NCT03638635|Secondary|Readmissions|Patient readmitted to hospital after discharge|Within 30 days of hospital discharge|Readmissions data was going to be collected from chart review. However, the study was prematurely terminated before this data could be collected.||||||
2526732|NCT03638635|Secondary|Complications|Patient suffered a complication (infection, small bowel obstruction, dehydration, deep vein thrombosis/pulmonary embolism, anastomotic leak, cardiac arrest, stroke, sepsis) after surgery|Within 30 days of surgery|Complications data was going to be collected from chart review. However, the study was prematurely terminated before this data could be collected.||||||
2526733|NCT03638635|Secondary|In-hospital Antiemetic Use|Amount of ondansetron patient required postoperatively during hospital stay, in milligrams|Time of transfer to post operative suite to time of discharge (usually up to 4 days after surgery).|Outcome data reported for subjects with non-missing data.|||mg||Standard Deviation|Mean
2526734|NCT03638635|Secondary|Length of Stay|Total postoperative hospital stay in days|Date of surgery to date of discharge (usually up to 4 days after surgery).|Outcome data reported for subjects with non-missing data.|||days||Inter-Quartile Range|Median
2526735|NCT03638635|Secondary|Time to Low Fiber Diet|Number of days from day of surgery until patient tolerates low fiber diet|From time of surgery until first time patient tolerates a low fiber diet without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).|Outcome data reported for subjects with non-missing data.|||days||Inter-Quartile Range|Median
2526736|NCT03638635|Secondary|Time to Clear Liquid Diet|Number of days from time of surgery until patient tolerates clear liquid diet|From time of surgery until first time patient tolerates clear liquids without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).|Outcome data reported for subjects with non-missing data.|||days||Inter-Quartile Range|Median
2526737|NCT03638635|Secondary|Time to Return of Bowel Function|Number of days from time of surgery until return of bowel function|From time of surgery until first time patient passes gas or stool per rectum or into ostomy bag. Assessed until date of discharge (usually up to 4 days after surgery).|Outcome data reported for subjects with non-missing data.|||days||Inter-Quartile Range|Median
2526738|NCT03638635|Secondary|Time to Patient Mobilization|Number of days from day of surgery until patient mobilization|From time of surgery until time of first patient ambulation post op. Assessed until date of discharge (usually up to 4 days after surgery).|Outcome data reported for subjects with non-missing data.|||days||Inter-Quartile Range|Median
2526739|NCT03638635|Secondary|Pain Score|Recorded on a scale of 0 (No pain) to 10 (Worst possible pain)|Approximately every 6 hours through postoperative day 3 by 1 pm|Outcome data reported for patients with non-missing data. Pain scores presented are the first postoperative pain score per subject only due to missing data.|||units on a scale||Inter-Quartile Range|Median
2526740|NCT03638635|Primary|In-hospital Postoperative Opioid Consumption|Daily overall opioid use recorded as morphine equivalents|up to postoperative day 3 at 1 pm|The amount of in-hospital postoperative opioid consumption was going to be obtained from the charts, where it is recorded as standard of care. However, this study was terminated prematurely before data could be collected from the charts; therefore no data are available for this outcome measure.||||||
2526741|NCT03638323|Secondary|Association Between Speech Therapy and Lack of Word|Patients with or without ongoing speech therapy and score at the lack of word questionnaire (BIMM) The Batterie Informatisée du Manque du Mot (BIMM) is a computerized assessment instrument for denominational disorders. It provides information on level of lexical impairment, type of error (phonological, semantic, visual perceptual) and response time. It comprises two tests: denomination of nouns (42 items) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.|at inclusion||||Participants|||Count of Participants
2526742|NCT03638323|Secondary|Association Between Hearing Aid and Lack of Word|Patients with or without hearing aid and score at the lack of word questionnaire (BIMM) The Batterie Informatisée du Manque du Mot (BIMM) is a computerized assessment instrument for denominational disorders. It provides information on level of lexical impairment, type of error (phonological, semantic, visual perceptual) and response time. It comprises two tests: denomination of nouns (42 items) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.|at inclusion||||Participants|||Count of Participants
2526743|NCT03638323|Secondary|Association Between Main Diagnosis and Lack of Word|Alzheimer's disease or related disease and score at the lack of word questionnaire (BIMM) The Batterie Informatisée du Manque du Mot (BIMM) is a computerized assessment instrument for denominational disorders. It provides information on level of lexical impairment, type of error (phonological, semantic, visual perceptual) and response time. It comprises two tests: denomination of nouns (42 items) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.|at inclusion||||Participants|||Count of Participants
2526744|NCT03638323|Secondary|Association Between Laterality and Lack of Word|Right or left handed patients and score at the lack of word questionnaire (BIMM) The Batterie Informatisée du Manque du Mot (BIMM) is a computerized assessment instrument for denominational disorders. It provides information on level of lexical impairment, type of error (phonological, semantic, visual perceptual) and response time. It comprises two tests: denomination of nouns (42 items) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.|at inclusion||||Participants|||Count of Participants
2526745|NCT03638323|Secondary|Association Between Accommodation Type and Lack of Word|Patient living at home or in an institution and score at the lack of word questionnaire (BIMM) The Batterie Informatisée du Manque du Mot (BIMM) is a computerized assessment instrument for denominational disorders. It provides information on level of lexical impairment, type of error (phonological, semantic, visual perceptual) and response time. It comprises two tests: denomination of nouns (42 items) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.|at inclusion||||Participants|||Count of Participants
2526746|NCT03638323|Secondary|Association Between Study Level and Lack of Word|Primary (certificate study), secondary and tertiary study (baccalaureat and more) level and score at the lack of word questionnaire (BIMM) The Batterie Informatisée du Manque du Mot (BIMM) is a computerized assessment instrument for denominational disorders. It provides information on level of lexical impairment, type of error (phonological, semantic, visual perceptual) and response time. It comprises two tests: denomination of nouns (42 items) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.|at inclusion||||Participants|||Count of Participants
2526747|NCT03638323|Secondary|Association Between Gender and Lack of Word|Male or female and score at the lack of word questionnaire (BIMM) The Batterie Informatisée du Manque du Mot (BIMM) is a computerized assessment instrument for denominational disorders. It provides information on level of lexical impairment, type of error (phonological, semantic, visual perceptual) and response time. It comprises two tests: denomination of nouns (42 items) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.|at inclusion||||Participants|||Count of Participants
2526748|NCT03638323|Secondary|Association Between Age and Lack of Word|Age of patients and score at the lack of word questionnaire (BIMM) The Batterie Informatisée du Manque du Mot (BIMM) is a computerized assessment instrument for denominational disorders. It provides information on level of lexical impairment, type of error (phonological, semantic, visual perceptual) and response time. It comprises two tests: denomination of nouns (42 items) and of verbs (28 items). The results are presented in a report including scores, description of qualitative errors, and results per item. An score less than 40 indicates lack of word.|at inclusion||||years||Full Range|Median
2526749|NCT03638323|Primary|Link Between Lack of Word and Presbycusis|"The Batterie Informatisée du Manque du Mot (BIMM) is a computerized assessment instrument for denominational disorders. It provides information on level of lexical impairment, type of error (phonological, semantic, visual perceptual) and response time. It comprises two tests: denomination of nouns (42 items, score range from 0 to 42) and of verbs (28 items, score range from 0 to 28). The results are presented in a report including scores, description of qualitative errors, and results per item. A global score of less than 40 indicates a lack of words. The score range is between 0 and 70.~The hearing questionnaire consists in 14 questions about concrete situations and a direct question about what the patient thinks of his hearing. Answers are quoted 0, 2 or 4 points. An overall score greater than 14 indicates presbycusis."|at inclusion||||score on a scale||Full Range|Median
2526750|NCT03637517|Secondary|AUCinf|AUC from time 0 to infinity (AUCinf)|21 days||||NG*H/ML||Geometric Coefficient of Variation|Geometric Mean
2526751|NCT03637517|Primary|C168|Plasma concentration at 168 hours|7 days||||NG/ML||Geometric Coefficient of Variation|Geometric Mean
2526752|NCT03637517|Primary|β|Apparent terminal phase elimination rate constant|21 days||||1/H||Standard Deviation|Mean
2526753|NCT03637517|Primary|Tmax|Time to Cmax.|21 days||||Hours||Standard Deviation|Mean
2526754|NCT03637517|Primary|AUCt|AUC from time 0 until the last measurable concentration (AUCt),|21 days||||NG*H/ML||Geometric Coefficient of Variation|Geometric Mean
2526755|NCT03637517|Primary|AUC168|Area under the plasma concentration-time curve from time 0 to 168 hours (AUC168)|168 hours||||NG*H/ML||Geometric Coefficient of Variation|Geometric Mean
2526756|NCT03637517|Primary|Cmax|Maximum observed DSM265 plasma concentration|21 days||||NG/ML||Geometric Coefficient of Variation|Geometric Mean
2526788|NCT03634306|Primary|Consumed CO2|Amount of CO2 Consumed in liters from placement of all surgical ports to colpotomy (hysterectomy) or closure of last uterine defect (myomectomy)|End of procedure||||Liters||Standard Deviation|Mean
2526789|NCT03634306|Primary|Quality of Surgical Field Visualization|Measure the quality of visualization in the laparoscopic field of view using a 5 point Visual Analog Scale. 0 is visible interference is imperceptible, 2-3 is perceptible to interfering, 4 is interfering, 5 is highly interfering)|End of procedure||||participants|||Number
2526757|NCT03636386|Secondary|Pain Intensity (PI)|Magnitude of pain expressed in millimeters (mm) referred by participants. PI was evaluated through visual analogue scale at moment of performing pressure algometry test in the sensitive point of upper trapezius muscle. PI was assessed with an analogous visual scale where the participant will mark the pain generated by the algometry on a scale of 1 to 100 millimeters. PI was valued in four occasions: PI1 pre (baseline), PI1 post, PI 2 (at day 3) and PI 3 (at day 7).|PIpre1 (baseline), PIpost1 (post baseline), PI2 (Day 3), PI3 (Day 7), assessed an average of 3 minutes at each session||||mm||Standard Deviation|Mean
2526758|NCT03636386|Primary|Pain Pressure Threshold (PPT)|Pain Intensity expressed in kilograms per square centimeter(kg/cm2) reported by participants when performing algometry test at sensitive point of upper trapezius muscle. PPT was valued in four occasions: PPT1 pre (baseline), PPT1 post, PPT 2 (at day 3) and PPT 3 (at day 7). PPT will be evaluated through the BASELINE® pressure algometer.|PPTpre1 (baseline), PPTpost1 (post baseline), PPT2 (Day 3), PPT3 (Day 7), assessed an average of 30 minutes at each session||||Kg/cm2||Standard Deviation|Mean
2526759|NCT03634579|Secondary|Number of Recurrences of Prostate Cancer at the End of 2nd Year Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation|Efficacy is assessed by recurrence rate at end of 2nd year, defined as the number of recurrences divided by the number of patients treated with MRI Guided Focal Laser Interstitial Thermal Ablation|Up to 24 months|Data were not collected/analyzed due to the study termination||||||
2526760|NCT03634579|Primary|Number of Subjects Experienced Change in Urinary Function|Urinary function will be assessed using International Prostate Symptom Score (IPSS) assessment for urinary function. The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions (maximum score 35) concerning urinary symptoms and one question concerning quality of life. Any score > 1 indicates presence of urinary dysfunction, higher score indicates increased severity.|3 weeks follow up||||Participants|||Count of Participants
2526761|NCT03634579|Primary|Number of Subjects Experienced Change in Erectile Function|Change in erectile function is assessed using Sexual Health Inventory For Men (SHIM) for erectile function. There are 5 questions and each question has 5 possible responses. If the patient's score is 21 or less, erectile dysfunction (ED) is present.|3 weeks follow up||||Participants|||Count of Participants
2526762|NCT03634579|Primary|Percentage of Grade 3 or Higher Complications as Defined as National Cancer Institute's Common Toxicity Criteria Version 4 Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation|Safety is assessed by percentage of grade 3 or higher complications or adverse events (AE) as defined as National cancer institute's common toxicity criteria version 4: incontinence or urinary retention necessitating surgical intervention or new-onset erectile dysfunction not responsive to medication.Grade refers to the severity of the AE. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.Grade 2 Moderate; minimal, local or non invasive intervention indicated; limiting age appropriate instrumental ADL. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.|Up to 24 months||||percentage of grade 3 or higher complica|||Number
2526763|NCT03634579|Primary|Number of Recurrences of Prostate Cancer at the End of 1 Year Among the Subjects Treated With MRI Guided Focal Laser Interstitial Thermal Ablation|Efficacy is assessed by recurrence rate at 1 year, defined as the number of recurrences divided by the number of patients treated with MRI Guided Focal Laser Interstitial Thermal Ablation|Up to 12 months|Data were not collected/analyzed due to the study termination||||||
2526764|NCT03634306|Secondary|Adverse Events Related to Smoke Clearing Device|Number of subjects with adverse events determined probably related or related to smoke clearing device|Intraoperative up to 2 week follow up visit||||Participants|||Count of Participants
2526765|NCT03634306|Secondary|Adverse Events Related to Procedure|Number of subjects with adverse events determined probably related or related to procedure|Intraoperative up to 2 weeks post procedure||||Participants|||Count of Participants
2526766|NCT03634306|Secondary|Number of Participants Reporting Non-opioid Pain Medication Use at Follow up|"The number of participants that reported non-opioid pain medication use at follow up visit recorded as yes or no. Data represent the number of participants that reported non-opioid pain medication use at follow up."|2 week follow up visit||||Participants|||Count of Participants
2526767|NCT03634306|Secondary|Number of Participants Reporting Opioid Pain Medication Use at Follow up|"The number of participants that reported opioid pain medication use at follow up visit recorded as yes or no. Data represent the number of participants that reported opioid pain medication use at follow up."|2 week follow up visit||||Participants|||Count of Participants
2526768|NCT03634306|Secondary|Number of Participants That Received Post-operative Non-opioid Pain Medication|"The number of participants that received post-operative non-opioid pain medication during hospital stay recorded as yes or no. Data represent the number of participants that received post-operative non-opioid pain medication during hospital stay."|Post-operative hospitalization||||Participants|||Count of Participants
2526769|NCT03634306|Secondary|Number of Participants That Received Post-operative Opioid Pain Medication|"The number of participants that received post-operative opioid pain medication during hospital stay recorded as yes or no. Data represent the number of participants that received post-operative opioid pain medication during hospital stay."|Post-operative hospitalization||||Participants|||Count of Participants
2526770|NCT03634306|Secondary|Postoperative Pain Numerical Rating Scale|Post operative pain evaluated according to a numerical rating scale from 0 (no pain) to 10 (worst pain possible)|2 weeks following procedure completion||||score on a scale||Standard Deviation|Mean
2526771|NCT03634306|Secondary|Postoperative Pain Numerical Rating Scale|Post operative pain evaluated according to a numerical rating scale from 0 (no pain) to 10 (worst pain possible)|Before hospital discharge||||score on a scale||Standard Deviation|Mean
2526772|NCT03634306|Secondary|Number of Participants With a Hospital Stay Less Than 24 Hours|"The number of participants with a hospital duration of stay less than 24 hours recorded as yes or no. Data represent the number of participants with a hospital stay less than 24 hours."|2 weeks following procedure completion||||Participants|||Count of Participants
2526773|NCT03634306|Secondary|Duration of Procedure|Time from placement of last surgical port to colpotomy (hysterectomy) or closure of last uterine defect (myomectomy)|Intraoperative||||Minutes||Standard Deviation|Mean
2526790|NCT03633825|Secondary|"Number of Participants in the Treatment Versus Control Conditions Reporting Their Experience Using Koko Was Good"|"The number of participants in the treatment versus control conditions reporting that their experience on the Koko digital platform was good versus bad using a two-option response question."|5 hours post intervention||||Participants|||Count of Participants
2526791|NCT03633825|Primary|Number of Participants Reporting Use of Crisis-referrals|The number participants indicating at follow-up that they used the crisis resources provided to them (e.g., called the suicide crisis hotline)|5 hours post intervention||||Participants|||Count of Participants
2526792|NCT03633526|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)||From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 6 weeks)|Safety set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2526793|NCT03633526|Secondary|Area Under the Concentration Versus Time Curve From Time 0 to 6 Hours (AUC0-6h) of TEZ Metabolite (M1-TEZ), and IVA Metabolite (M1-IVA)||Day 1 and Day 15|PK set. Here “Number analyzed” signifies those participants who were evaluable at specified timepoints.|||h*mcg/mL||Standard Deviation|Mean
2526794|NCT03633526|Secondary|Observed Pre-Dose Concentration (Ctrough) of TEZ Metabolite (M1-TEZ), and IVA Metabolite (M1-IVA)||Day 8 and Day 15|PK set. Here “Number analyzed” signifies those participants who were evaluable at specified timepoints.|||mcg/mL||Standard Deviation|Mean
2526795|NCT03633526|Secondary|Maximum Observed Concentration (Cmax) of TEZ Metabolite (M1-TEZ), and IVA Metabolite (M1-IVA)||Day 1 and Day 15|PK set. Here “Number analyzed” signifies those subjects who were evaluable at the specified timepoint.|||mcg/mL||Standard Deviation|Mean
2526796|NCT03633526|Primary|Area Under the Concentration Versus Time Curve From Time 0 to 6 Hours (AUC0-6h) of VX-659, TEZ, and IVA||Day 1 and Day 15|PK set. Here “Number analyzed” signifies those participants who were evaluable at specified timepoints.|||hour*mcg/mL (h*mcg/mL)||Standard Deviation|Mean
2526797|NCT03633526|Primary|Observed Pre-Dose Concentration (Ctrough) of VX-659, TEZ, and IVA||Day 8 and Day 15|PK set. Here “Number analyzed” signifies those participants who were evaluable at specified timepoints.|||mcg/mL||Standard Deviation|Mean
2526798|NCT03633526|Primary|Maximum Observed Concentration (Cmax) of VX-659, TEZ, and IVA||Day 1 and Day 15|Pharmacokinetic (PK) set included participants who received at least 1 dose of study drug and for whom the primary PK data were considered to be sufficient and interpretable. Here “Number analyzed” signifies those subjects who were evaluable at the specified timepoint.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2526799|NCT03633487|Secondary|Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)|"Intensity was determined by the Investigator. For symptomatic adverse events (AEs) the following definitions were applied.~Mild = AE did not limit usual activities; subject may have experienced slight discomfort.~Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort.~Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain.~Relationship to Investigational Medicinal Products (IMP) Unlikely = Slight, but remote, chance that AE was caused by IMP. Possible = Reasonable suspicion that the AE was caused by IMP. Probable = Most likely that AE was caused by IMP."|Up to Day 2||||Participants|||Count of Participants
2526800|NCT03633487|Primary|Time at Which the Percentage of Subjects Achieved a Target Concentration of at Least 65 ng/mL (T65)|Pharmacokinetic Parameter (T65) is te time when guaifenesin plasma concentration achieved a target concentration of at least 65 ng/mL.|0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1||||hr||Standard Deviation|Mean
2526801|NCT03633487|Primary|Terminal Elimination Half Life (t1/2)|Pharmacokinetic Parameter (t1/2) is Apparent terminal elimination half-life.|0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1||||hr||Standard Deviation|Mean
2526802|NCT03633487|Primary|Apparent First-order Terminal Elimination Rate Constant (Kel)|Pharmacokinetic Parameter (Kel) Apparent first-order terminal elimination rate constant|0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1||||1/hr||Standard Deviation|Mean
2526803|NCT03633487|Primary|Percentage of AUC0-inf Extrapolated Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin|Pharmacokinetic Parameter (AUC%extrap) Percent of AUC0-inf extrapolated AUCR = 100 - (AUC0-t/ AUC0-inf) x 100|0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1||||Percentage of AUC0-inf extrapolated AUCR||Standard Deviation|Mean
2526804|NCT03633487|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf)|Pharmacokinetic Parameter (AUC0-inf) Area under the plasma concentration versus time curve from time 0 to infinity.|0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1||||ng*hr/mL||Standard Deviation|Mean
2526805|NCT03633487|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t)|Pharmacokinetic Parameter (AUC0-t) is Area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration|0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1||||ng*hr/mL||Standard Deviation|Mean
2526806|NCT03633487|Primary|Time of the Maximum Observed Plasma Concentration (Tmax)|Pharmacokinetic Parameter (Tmax) Time of the maximum observed plasma concentration|0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1||||hr||Standard Deviation|Mean
2526888|NCT03628456|Primary|Forced Vital Capacity (FVC) Assessed in Participants at Baseline and With Both Devices|Forced Vital Capacity (FVC) is the total amount of air exhaled during the FEV test, measured using standard spirometry techniques|30 minutes||||L||Full Range|Mean
2526807|NCT03633487|Primary|Maximum Observed Plasma Concentration (Cmax)|Pharmacokinetic Parameters (Cmax) Maximum observed plasma concentration.|0 (pre-dose), 1,2,3,4,5,6,7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45, 50, and 55 minutes; 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 6, 7, 8, 10, 12, 14, 16 and 24 hours on Day 1|Pharmacokinetic (PK) population includes subjects with at least one PK sample. Available data from any subjects who vomited within 12 hours after dosing were to be included in the PK data sets.|||ng/mL||Standard Deviation|Mean
2526808|NCT03633448|Secondary|Number of Adverse Events (AEs) of Participants|"Intensity determination:~Mild=AE does not limit usual activities;subject may experience slight discomfort; Moderate= AE results in some limitation of usual activities; subject may experience significant discomfort; Severe=AE results in an inability to carry out usual activities; subject may experience intolerable discomfort or pain; Unlikely=Slight but remote chance that the AE was caused by study drug but the balance of judgment is that it was most likely not due to the study drug Possible=Reasonable suspicion that the AE was caused by the study drug; Probable=Most likely that the AE was caused by study drug."|Upto Day 1|PK Data Sets|||Events|||Number
2526809|NCT03633448|Primary|Apparent First-order Terminal Elimination Rate Constant (Kel)|Apparent first-order terminal elimination rate constant calculated from a semilog plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares (LS) regression analysis using the maximum number of points (e.g., three or more non-zero plasma concentrations) in the terminal log-linear phase.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours|PK Data Sets|||1/hr||Standard Deviation|Mean
2526810|NCT03633448|Primary|Apparent First-order Terminal Elimination Half-life (t½)|Apparent first-order terminal elimination half-life, calculated as ln(2)/kel.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours|PK Data Sets|||hr||Standard Deviation|Mean
2526811|NCT03633448|Primary|Time to Maximum Observed Concentration (Tmax) of Guaifenesin|Pharmacokinetic Parameter (Tmax) Time of the maximum observed plasma concentration.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours|PK Data Sets|||hr||Standard Deviation|Mean
2526812|NCT03633448|Primary|Maximum Observed Plasma Concentration (Cmax) of Guaifenesin|Pharmacokinetic Parameter (Cmax) Maximum observed plasma concentration.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours|PK Data Sets|||ng/mL||Standard Deviation|Mean
2526813|NCT03633448|Primary|Percent of AUC 0-inf Extrapolated (AUC%Extrapolated)|Percent of AUC 0-inf extrapolated, calculated as (1 - AUC 0-t / AUC 0-inf) x 100.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours|PK Data Sets|||Percentage||Standard Deviation|Mean
2526814|NCT03633448|Primary|Area Under Plasma Concentration-time Curve From Time 0 to Infinity (AUC(0-inf)) of Guaifenesin|Area under the plasma concentration versus time curve from time 0 to infinity, calculated as AUC 0-t + C last/kel, where C last is the last measurable concentration and kel is the apparent first-order terminal elimination rate constant.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours|PK Data Sets|||ng*hr/mL||Standard Deviation|Mean
2526815|NCT03633448|Primary|Area Under Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC(0-t)) of Guaifenesin|Area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration, as calculated by the linear trapezoidal method.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours|Pharmacokinetic (PK) Data Sets included only those subjects who swallowed the whole dose (did not spit it out), did not vomit within one hour of dosing, and who had a sufficient number of plasma concentrations to estimate the primary PK parameters for at least one dose level.|||ng*hr/mL||Standard Deviation|Mean
2526816|NCT03633344|Secondary|Quantity of Used Medication|Mean quantity of tablets per treatment course|From randomisation up to 5 days||||tablets||Inter-Quartile Range|Median
2526817|NCT03633344|Secondary|Duration of Treatment|Mean duration of treatment|From randomisation up to 5 days||||days||95% Confidence Interval|Mean
2526818|NCT03633344|Secondary|Compliance Rate|Percent of patients administered the investigational production who discontinued the study|From randomisation up to 5 days||||Participants|||Count of Participants
2526819|NCT03633344|Primary|Reduction in Frequency of Defecation to 3 Times Per Day|Percent of patients administered the investigational production who achieved the efficacy endpoint (reduction in frequency of defecation to 3 times per day, absence of loose stool) on Day 5 or earlier|From randomisation up to 5 days||||Participants|||Count of Participants
2526820|NCT03630185|Secondary|Number of Patients Who Will be Progressing to Ablation Therapy|Progression to ablation therapy will be determined by patient preference for further intervention.|6 months|Data was not collected for this outcome measure.||||||
2526821|NCT03630185|Primary|Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS)|"The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health.~The scoring scale is from 0 to 100, the higher the score the better the health related quality of life."|6 months|This data was not collected for any in the Off-the-rack stockings (Sigvaris) arm or any in the Custom-manufactured compression hosiery (Isobar) arm.||||||
2526822|NCT03630185|Primary|Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS)|"The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health.~The scoring scale is from 0 to 100, the higher the score the better the health related quality of life."|90 days|This data was not collected for 4 in the Off-the-rack stockings (Sigvaris) arm and 3 in the Custom-manufactured compression hosiery (Isobar) arm.|||score on a scale||Standard Deviation|Mean
2526823|NCT03630185|Primary|Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS)|"The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health.~The scoring scale is from 0 to 100, the higher the score the better the health related quality of life."|30 days|This data was not collected for 3 in the Off-the-rack stockings (Sigvaris) arm and 3 in the Custom-manufactured compression hosiery (Isobar) arm.|||score on a scale||Standard Deviation|Mean
2526824|NCT03630185|Primary|Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS)|"The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health.~The scoring scale is from 0 to 100, the higher the score the better the health related quality of life."|Baseline|This data was not collected for 2 in the Off-the-rack stockings (Sigvaris) arm.|||score on a scale||Standard Deviation|Mean
2526825|NCT03630185|Primary|Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS)|"The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health.~The scoring scale is from 0 to 100, the higher the score the better the health related quality of life."|6 months|This data was not collected for any in the Off-the-rack stockings (Sigvaris) arm or any in the Custom-manufactured compression hosiery (Isobar) arm.||||||
2526826|NCT03630185|Primary|Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS)|"The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health.~The scoring scale is from 0 to 100, the higher the score the better the health related quality of life."|90 days|This data was not collected for 4 in the Off-the-rack stockings (Sigvaris) arm and 3 in the Custom-manufactured compression hosiery (Isobar) arm.|||score on a scale||Standard Deviation|Mean
2526827|NCT03630185|Primary|Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS)|"The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health.~The scoring scale is from 0 to 100, the higher the score the better the health related quality of life."|30 days|This data was not collected for 3 in the Off-the-rack stockings (Sigvaris) arm and 3 in the Custom-manufactured compression hosiery (Isobar) arm.|||score on a scale||Standard Deviation|Mean
2526828|NCT03630185|Primary|Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS)|"The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health.~The scoring scale is from 0 to 100, the higher the score the better the health related quality of life."|Baseline|This data was not collected for 2 in the Off-the-rack stockings (Sigvaris) arm.|||score on a scale||Standard Deviation|Mean
2526829|NCT03630185|Primary|Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate)|"The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health.~The scoring scale is from 0 to 100, the higher the score the better the health related quality of life."|6 months|This data was not collected for any in the Off-the-rack stockings (Sigvaris) arm or any in the Custom-manufactured compression hosiery (Isobar) arm.||||||
2526830|NCT03630185|Primary|Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate)|"The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health.~The scoring scale is from 0 to 100, the higher the score the better the health related quality of life."|90 days|This data was not collected for 4 in the Off-the-rack stockings (Sigvaris) arm and 3 in the Custom-manufactured compression hosiery (Isobar) arm.|||score on a scale||Standard Deviation|Mean
2526831|NCT03630185|Primary|Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate)|"The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health.~The scoring scale is from 0 to 100, the higher the score the better the health related quality of life."|30 days|This data was not collected for 3 in the Off-the-rack stockings (Sigvaris) arm and 3 in the Custom-manufactured compression hosiery (Isobar) arm.|||score on a scale||Standard Deviation|Mean
2526832|NCT03630185|Primary|Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate)|"The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health.~The scoring scale is from 0 to 100, the higher the score the better the health related quality of life."|Baseline|This data was not collected for 2 in the Off-the-rack stockings (Sigvaris) arm.|||score on a scale||Standard Deviation|Mean
2526833|NCT03630185|Primary|Pain as Assessed by Brief Pain Inventory|"The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the World Health Organization Collaborating Center for Symptom Evaluation in Cancer Care.~The score is an average of seven questions about pain interference in life. The score scale is from 0 to 10. 0 being pain does not interfere and 10 being that it completely interferes. 10 would be a worst outcome."|6 months|Data was not collected for this outcome measure.||||||
2526834|NCT03630185|Primary|Pain as Assessed by Brief Pain Inventory|"The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the World Health Organization Collaborating Center for Symptom Evaluation in Cancer Care.~The score is an average of seven questions about pain interference in life. The score scale is from 0 to 10. 0 being pain does not interfere and 10 being that it completely interferes. 10 would be a worst outcome."|90 days|Data was not collected for this outcome measure.||||||
2526835|NCT03630185|Primary|Pain as Assessed by Brief Pain Inventory|"The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the World Health Organization Collaborating Center for Symptom Evaluation in Cancer Care.~The score is an average of seven questions about pain interference in life. The score scale is from 0 to 10. 0 being pain does not interfere and 10 being that it completely interferes. 10 would be a worst outcome."|6 weeks|Data was not collected for this outcome measure.||||||
2526836|NCT03630185|Primary|Pain as Assessed by Brief Pain Inventory|"The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the World Health Organization Collaborating Center for Symptom Evaluation in Cancer Care.~The score is an average of seven questions about pain interference in life. The score scale is from 0 to 10. 0 being pain does not interfere and 10 being that it completely interferes. 10 would be a worst outcome."|Baseline|Data was not collected for this outcome measure.||||||
2526837|NCT03630185|Primary|Pain Management Experienced During Their Postoperative Care as Assessed by Five-point Satisfaction Scale|"Five-point satisfaction scale consists of patients rating their overall postoperative pain management experience using a 5-point rating system. The scale ranges from 1 to 5, with 1 being extremely dissatisfied, 2 somewhat dissatisfied, 3 Neutral/Neither satisfied nor dissatisfied, 4 somewhat satisfied and 5 extremely satisfied with their postoperative pain care."|6 months|Data was not collected for this outcome measure.||||||
2526838|NCT03630185|Primary|Pain Management Experienced During Their Postoperative Care as Assessed by Five-point Satisfaction Scale|"Five-point satisfaction scale consists of patients rating their overall postoperative pain management experience using a 5-point rating system. The scale ranges from 1 to 5, with 1 being extremely dissatisfied, 2 somewhat dissatisfied, 3 Neutral/Neither satisfied nor dissatisfied, 4 somewhat satisfied and 5 extremely satisfied with their postoperative pain care."|90 days|Data was not collected for this outcome measure.||||||
2526839|NCT03630185|Primary|Pain Management Experienced During Their Postoperative Care as Assessed by Five-point Satisfaction Scale|"Five-point satisfaction scale consists of patients rating their overall postoperative pain management experience using a 5-point rating system. The scale ranges from 1 to 5, with 1 being extremely dissatisfied, 2 somewhat dissatisfied, 3 Neutral/Neither satisfied nor dissatisfied, 4 somewhat satisfied and 5 extremely satisfied with their postoperative pain care."|6 weeks|Data was not collected for this outcome measure.||||||
2526840|NCT03630016|Primary|It Was Expected That the Accuracy Root Mean Square (ARMS) Between Measured SpO2 of Owlet Smart Sock V2 v1.1 and Reference SpO2 Would Meet the Required Specification of ARMS 3% or Lower in Non-motion Conditions for the Range of 70 - 100%|The purpose of the study was to evaluate the accuracy of the blood oxygen saturation (SpO2) at rest over the range of 70-100% compared to arterial blood samples assessed by standard methods [Co-Oximetry]. A standard pulse oximeter accuracy is evaluated by the Accuracy Root Mean Square (ARMS). The results of accurate performance of the oximetry system require ARMS of 3% or less in non-motion conditions for the range of 70-100% SpO2 per standard.|Acute immediate assessment of the sensor accuracy compared to CO-oximetry||||Percent SpO2|Number of Data Points||Number
2526841|NCT03629184|Secondary|Plasma Concentrations of S-033447 by Dosage|Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.|24, 72, 96 and 240 hours post-dose|The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point|||ng/mL||Standard Deviation|Mean
2526842|NCT03629184|Secondary|Plasma Concentrations of Baloxavir Marboxil by Dosage|Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.|24, 72, 96 and 240 hours post-dose|The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point|||ng/mL||Standard Deviation|Mean
2526843|NCT03629184|Secondary|Time to Maximum Plasma Concentration (Tmax) of S-033447|Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.|Up to Day 10|The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point|||hours||Standard Deviation|Mean
2526844|NCT03629184|Secondary|Time to Maximum Plasma Concentration (Tmax) of Baloxavir Marboxil|Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.|Up to Day 10|The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point|||hours||Standard Deviation|Mean
2526845|NCT03629184|Secondary|Maximum Plasma Concentration (Cmax) of S-033447|Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.|Up to Day 10|The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point|||ng/mL||Standard Deviation|Mean
2526846|NCT03629184|Secondary|Maximum Plasma Concentration (Cmax) of Baloxavir Marboxil|Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.|Up to Day 10|The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point|||ng/mL||Standard Deviation|Mean
2526847|NCT03629184|Secondary|Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) of S-033447.|Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.|Up to Day 10|The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point|||ng.hr/mL||Standard Deviation|Mean
2526848|NCT03629184|Secondary|Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) of Baloxavir Marboxil|Dose groups correspond to body-weight groups. 2mg/kg dose was used for subjects <20 kgs and 40 mg dose was used for subjects >20 kgs.|Up to Day 10|The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point|||ng.hr/mL||Standard Deviation|Mean
2526849|NCT03629184|Secondary|Area Under the Curve in the Amount of Virus RNA (RT-PCR)|AUC in virus RNA (RT-PCR) is defined as AUC of change from baseline in the amount of virus RNA (RT-PCR) from Day 1 to Day 10. AUC is calculated using the trapezoidal method similar to AUC in virus titer.|Day 1 - Day 10|Includes all participants with positive virus RNA by RT-PCR on Day 1 and at least 1 post-baseline test.|||log₁₀ VPs/mL*hours||Standard Deviation|Mean
2526850|NCT03629184|Secondary|Area Under the Curve in Virus Titer|Area under the curve (AUC) in virus titer was calculated using the trapezoidal method.|Day 1 - Day 29|Includes all participants with post-baseline Virology assessment and a positive virus titer on Day 1|||log₁₀[TCID₅₀/mL]*hours||Standard Deviation|Mean
2526851|NCT03629184|Secondary|Percentage of Participants Positive by RT-PCR at Day 2, 4, 6, 10, 15, 29||Day 2, 3 (optional), 4, 6, 10, 15 (optional), 29|Includes all participants with positive virus RNA by RT-PCR on Day 1|||percentage of participants|||Number
2526852|NCT03629184|Secondary|Percentage of Participants With Positive Influenza Virus Titer at Day 2, 4, 6, 10||Baseline, Day 2, 3 (optional), 4, 6, 10|Includes all participants with a positive virus titer on Day 1|||percentage of participants|||Number
2526853|NCT03629184|Secondary|Change From Baseline in the Amount of Virus RNA (RT-PCR) at Day 2, 4, 6, 10, 15, 29|If the amount of virus RNA was less than the lower limit of quantification, the amount of virus RNA was imputed as 2.18 for flu A and 2.93 for flu B (log10 virus particles/mL)|Baseline, Day 2, 3 (optional), 4, 6, 10, 15 (optional), 29|Includes all participants with positive virus RNA by RT-PCR on Day 1|||log10 virus particles/mL||Standard Deviation|Mean
2526854|NCT03629184|Secondary|Change From Baseline in Influenza Virus Titer at Day 2, 4, 6, 10, 15, 29|Influenza virus titer (log10TCID50/ML) is the quantity of influenza virus in a given volume within the samples obtained from nasal swabs. If influenza virus titer was less than the lower limit of quantification, the virus titer was imputed as 0.749 (log10TCID50/mL). A lower value indicates lower viral titer.|Baseline, Day 2, 3 (optional), 4, 6, 10, 15 (optional), 29|Includes all participants with a positive virus titer on Day 1|||log10TCID50/ML||Standard Deviation|Mean
2526855|NCT03629184|Secondary|Time to Cessation of Viral Shedding by RT-PCR|Time to cessation of viral shedding by RT-PCR, in hours, is defined as the time between the initiation of any study treatment and first time when the virus RNA by RT-PCR is below the limit of detection.|Day 1 - Day 29|Includes all participants with post-baseline Virology assessment and a positive virus RNA by RT-PCR on Day 1. Participants whose virus RNA did not reach the limit by the last observation time point are treated as censored at that time point.|||hours||95% Confidence Interval|Median
2526856|NCT03629184|Secondary|Time to Cessation of Viral Shedding by Virus Titer|Time to cessation of viral shedding by virus titer is defined as the time, in hours, between the initiation of any study treatment and first time when the influenza virus titer is below the limit of detection.|Day 1 - Day 29|Includes all participants with post-baseline Virology assessment and a positive virus titer on Day 1|||hours||95% Confidence Interval|Median
2526857|NCT03629184|Secondary|Percentage of Participants Requiring Antibiotics||Up to Day 29|Includes all participants who have had a laboratory confirmation of influenza infection (polymerase chain reaction [PCR] result) from any swab sample collected at baseline or during the study|||percentage of participants|||Number
2526858|NCT03629184|Secondary|Percentage of Participants With Influenza-Related Complications|Influenza related complications include death, hospitalization, radiologically confirmed pneumonia, bronchitis, sinusitis, otitis media, encephalitis/encephalopathy, febrile seizures, myositis.|Up to Day 29|Includes all participants who have had a laboratory confirmation of influenza infection (polymerase chain reaction [PCR] result) from any swab sample collected at baseline or during the study|||percentage of participants|||Number
2526859|NCT03629184|Secondary|Frequency of Influenza-Related Complications|Influenza related complications include death, hospitalization, radiologically confirmed pneumonia, bronchitis, sinusitis, otitis media, encephalitis/encephalopathy, febrile seizures, myositis.|Up to Day 29|Includes all participants who have had a laboratory confirmation of influenza infection (polymerase chain reaction [PCR] result) from any swab sample collected at baseline or during the study|||count of events|||Number
2526860|NCT03629184|Secondary|Time to Return to Normal Health and Activity|"Time to Return to Normal health and activity' is identified by a 'Yes' response to the following question on the CARIFS: Since the last assessment has the patient been able to return to day care/school, or resume his or her normal daily activity in the same way as performed prior to developing the flu?"|Up to Day 15|Includes all participants with CARIFS Assessment who have had a laboratory confirmation of influenza infection (polymerase chain reaction [PCR] result) from any swab sample collected at baseline or during the study.|||hours||95% Confidence Interval|Median
2526861|NCT03629184|Secondary|Duration of Symptoms|The clinical efficacy of baloxavir marboxil is evaluated by duration of symptoms i.e., alleviation of all symptoms as defined by a score of 0 [no problem] or 1 [minor problem] and remaining so for at least 21.5 hours, for all 18 symptoms specified in the CARIFS questionnaire.|Up to Day 15|Includes all participants with CARIFS Assessment who have had a laboratory confirmation of influenza infection (polymerase chain reaction [PCR] result) from any swab sample collected at baseline or during the study.|||hours||95% Confidence Interval|Median
2526862|NCT03629184|Secondary|Duration of Fever|Length of time taken by participants to return to afebrile state [tympanic temperature ≤ 37.2°C] and remaining so for at least 21.5 hours.|Up to Day 15|Includes all participants with CARIFS Assessment who have had a laboratory confirmation of influenza infection (polymerase chain reaction [PCR] result) from any swab sample collected at baseline or during the study.|||hours||95% Confidence Interval|Median
2526863|NCT03629184|Secondary|Time to Alleviation of Influenza Signs and Symptoms|"Time to alleviation of influenza signs and symptoms is defined as the length of time taken from the start of treatment to the point at which all of the following criteria are met and remain so for at least 21.5 hours:~A score of 0 (no problem) or 1 (minor problem) for cough and nasal symptoms (items 14 and 15 of the Canadian Acute Respiratory Illness and Flu Scale [CARIFS])~A yes response to the following question on the CARIFS: Since the last assessment has the subject been able to return to day care/school, or resume his or her normal daily activity in the same way as performed prior to developing the flu?~First return to afebrile state (tympanic temperature ≤37.2 degree Celsius [°C])"|Up to Day 15|Includes all participants with CARIFS Assessment who have had a laboratory confirmation of influenza infection (polymerase chain reaction [PCR] result) from any swab sample collected at baseline or during the study|||hours||95% Confidence Interval|Median
2526889|NCT03628456|Primary|Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices|Peak Expiratory Flow (PEF) measures the peak flow during a forced exhalation, measured using standard spirometry techniques|30 minutes||||L/s||Full Range|Mean
2528111|NCT03527966|Secondary|Mean Inpatient Length of Stay||Average of 3 days in hospital|The study was terminated early before any patients were randomized to the control group.|||days||Full Range|Mean
2526864|NCT03629184|Secondary|Plasma Concentrations of S-033447 - Extensive PK Population|Results provided by body-weight groups for participants in the Baloxavir Marboxil arm. Values below lower limit of quantification (0.5 ng/mL) are set to zero.|Days 1 (Post-Dose), 2, 4, 6 and 10|The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point. Extensive PK population comprises all participants in the PK population who provided informed consent to intensive PK sampling (additional time points for sample collection on Day 1)|||ng/mL||Standard Deviation|Mean
2526865|NCT03629184|Secondary|Plasma Concentrations of Baloxavir Marboxil - Extensive PK Population|Results provided by body-weight groups for participants in the Baloxavir Marboxil arm. Values below lower limit of quantification (0.5 ng/mL) are set to zero.|Days 1 (Post-Dose), 2, 4, 6 and 10|The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point. Extensive PK population comprises all participants in the PK population who provided informed consent to intensive PK sampling (additional time points for sample collection on Day 1)|||ng/mL||Standard Deviation|Mean
2526866|NCT03629184|Secondary|Plasma Concentrations of S-033447 - Sparse PK Population|Results provided by body-weight groups for participants in the Baloxavir Marboxil arm.|Days 1 (Post-Dose), 2, 4, 6 and 10|The PK population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point. Sparse PK population comprises all participants in the PK population who did not provide informed consent to intensive PK sampling|||ng/mL||Standard Deviation|Mean
2526867|NCT03629184|Secondary|Plasma Concentrations of Baloxavir Marboxil - Sparse PK Population|Results provided by body-weight groups for participants in the Baloxavir Marboxil arm. Values below lower limit of quantification (0.5 ng/mL) are set to zero.|Days 1 (Post-Dose), 2, 4, 6 and 10|The pharmacokinetic (PK) population consists of all participants that have at least one post-dose drug concentration measurement at a scheduled visit time point. Sparse PK population comprises all participants in the PK population who did not provide informed consent to intensive PK sampling|||ng/mL||Standard Deviation|Mean
2526868|NCT03629184|Primary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.|Up to Day 29||||percentage of participants|||Number
2526869|NCT03629054|Secondary|Percentage of Patients With Drug-related Adverse Events (AEs)|Percentage of patients with investigator defined drug−related AEs are presented.|All adverse events (AEs) which occurred through the treatment phase and throughout the residual effect period (REP), up to 7 days.|TS|||Participants|||Number
2526870|NCT03629054|Secondary|Area Under the Concentration-time Curve of the Metformin Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)|AUC0-∞, area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity is presented. SE is a geometric SE.|PK samples were collected 1:30 h:m pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 h:m after drug administration.|PKS|||ng*h/mL||Standard Error|Geometric Mean
2526871|NCT03629054|Secondary|Area Under the Concentration-time Curve of the Linagliptinin Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)|AUC0-∞, area under the concentration-time curve of the linagliptin in plasma over the time interval from 0 extrapolated to infinity is presented. SE is a geometric SE.|PK samples were collected 1:30 h:m pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 h:m after drug administration.|PKS|||nmol*h/L||Standard Error|Geometric Mean
2526872|NCT03629054|Secondary|Area Under the Concentration-time Curve of the Empagliflozin Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)|AUC0-∞, area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 extrapolated to infinity is presented. SE is a geometric SE.|PK samples were collected 1:30 h:m pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 h:m after drug administration.|PKS|||nmol*h/L||Standard Error|Geometric Mean
2526873|NCT03629054|Primary|Maximum Measured Concentration of the Metformin in Plasma (Cmax)|Cmax, maximum measured concentration of the metformin in plasma is presented. SE is a geometric SE.|PK samples were collected 1:30 h:m pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 h:m after drug administration.|PKS|||nanogram/ millilitre (ng/ mL)||Standard Error|Geometric Mean
2526874|NCT03629054|Primary|Maximum Measured Concentration of the Linagliptin in Plasma (Cmax)|Cmax, maximum measured concentration of the linagliptin in plasma is presented. SE is a geometric SE.|PK samples were collected 1:30 h:m pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 h:m after drug administration.|PKS|||nanomole/Litre (nmol/ L)||Standard Error|Geometric Mean
2526875|NCT03629054|Primary|Maximum Measured Concentration of the Empagliflozin in Plasma (Cmax)|Cmax, maximum measured concentration of the empagliflozin in plasma is presented. SE is a geometric SE.|PK samples were collected 1:30 h:m pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 h:m after drug administration.|PKS|||nanomole/Litre (nmol/ L)||Standard Error|Geometric Mean
2526876|NCT03629054|Primary|Area Under the Concentration-time Curve of the Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (h) (AUC0-72)|AUC0-72, area under the concentration-time curve of the linagliptin in plasma over the time interval from 0 to 72 h is presented. SE is a geometric SE.|PK samples were collected 1:30 h:m pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 h:m after drug administration.|PKS|||nmol*h/L||Standard Error|Geometric Mean
2526877|NCT03629054|Primary|Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|AUC0-tz, Area under the concentration-time curve of the metformin in plasma over the time interval from 0 to the last quantifiable data point is presented. Standard error (SE) is a geometric SE.|Pharmacokinetic (PK) samples were collected 1:30 hours:minutes (h:m) pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 h:m after drug administration.|PKS|||nanogram*h/mL (ng*h/mL)||Standard Error|Geometric Mean
2526878|NCT03629054|Primary|Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|AUC0-tz, Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 to the last quantifiable data point is presented. Standard error (SE) is a geometric SE.|Pharmacokinetic (PK) samples were collected 1:30 hours:minutes (h:m) pre-dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 h:m after drug administration.|Pharmacokinetic parameter set (PKS): PKS included all subjects in the treated set (TS) who provided at least one primary or secondary PK parameter that was not excluded due to protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.|||nanomole*hour/litre (nmol*h/L)||Standard Error|Geometric Mean
2526879|NCT03629041|Primary|Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 3|Pain levels were recorded using a Verbal Pain Grading. For the verbal pain grading, subjects were asked to score either zero, mild, moderate or severe. In test 3, the same needle as test 1 and test 2 was again inserted through the oral mucosa and the cartridge of local anaesthetic was injected into the site.|Following three minutes of application of topical anaesthetic with a patch, the 3 tests were performed and the pain score recorded immediately after each test.||||Participants|||Count of Participants
2526880|NCT03629041|Primary|Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 2|Pain levels were recorded using a Verbal Pain Grading. For the verbal pain grading, subjects were asked to score either zero, mild, moderate or severe. In test 2, the same needle as test 1 was inserted through the oral mucosa and down to contact bone.|Following three minutes of application of topical anaesthetic with a patch, the 3 tests were performed and the pain score recorded immediately after each test.||||Participants|||Count of Participants
2526881|NCT03629041|Secondary|Adverse Events in Healthy Participants When a Proprietary Topical 5% Lidocaine Dental Gel Was Applied to the Oral Mucosa With a Microneedle Patch and a Patch With no Microneedles, Prior to Infiltration With Local Anaesthesia.|Adverse events were recorded|Events were collected from the time of informed consent until end of treatment or when an ongoing AE had resolved whichever was latest, unless the PI & the Innoture contact from the clinical investigation plan agreed that no further follow up was needed.||||Events|||Number
2526882|NCT03629041|Primary|Verbal Pain Grading, When Topical 5% Lidocaine Dental Gel is Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With No Microneedle Patch, Prior to Infiltration With Local Anaesthesia. Test 1|Pain levels will be recorded using a Verbal Pain Grading. For the verbal pain grading, subjects are asked to score either zero, mild, moderate or severe. In test 1, a short dental needle, mounted on a dental syringe containing a cartridge of 2% lidocaine hydrochloride and 1:80,000 adrenaline, was used to penetrate the oral mucosa at the treated site.|Following three minutes of application of topical anaesthetic with a patch, the 3 tests were performed and the pain score recorded immediately after each test.||||Participants|||Count of Participants
2526883|NCT03629041|Primary|VAS in Healthy Participants, When Topical 5% Lidocaine Dental Gel Was Applied to the Upper Palatal and Upper Anterior Buccal Sulcus Areas With a Microneedle Patch and a Patch With no Microneedles, Prior to Infiltration With Local Anaesthesia.|Pain levels were recorded using a visual analogue scale (VAS). When responding to the VAS item, subjects were required to indicate their level of pain by indicating a position along a continuous line between two end-points of no pain (0) and worst pain imaginable (100). The lower the score the better the outcome. The topical lidocaine was applied either with a microneedle patch or a patch with no microneedles for 3 minutes. Immediately afterwards three tests were performed: Test 1, a short dental needle, mounted on a dental syringe containing a cartridge of 2% lidocaine hydrochloride and 1:80,000 adrenaline, was used to penetrate the oral mucosa at the treated site; test 2, the same needle was inserted through the oral mucosa and down to contact bone; test 3, the same needle was again inserted through the oral mucosa and the cartridge of local anaesthetic was injected into the site.|Following 3 minutes of application of topical anaesthetic using a patch, the 3 tests were performed and the pain score recorded immediately after each test.||||units on a scale||Standard Deviation|Mean
2526884|NCT03628885|Primary|Intention to Vaccinate Against HPV in the Next 12 Months|Each parent will be asked to respond to this question. The response will be scaled from 1-10 in terms of parental intent regarding vaccination, with higher scores meaning greater parental intent to vaccinate children.|Immediately after video intervention has been administered||||score on a scale||95% Confidence Interval|Mean
2526885|NCT03628599|Primary|Monocular Corrected Distance Visual Acuity (VA)|"Monocular (each eye) corrected (with spectacles or other visual corrective devices) VA was performed under dimmed room illumination using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at distance. VA was reported in logMAR (logarithm of the minimum angle of resolution), with a lower logMAR indicating better visual acuity. No inferential hypotheses was planned for this endpoint."|Week 4|Safety Analysis Set with non-missing response|||logMAR|Eyes|Standard Deviation|Mean
2526886|NCT03628456|Primary|Forced Expiratory Flow (FEF25-75%) Assessed in Participants at Baseline and With Both Devices|Forced Expiratory Flow (25-75%) is the average flow from the point at which 25% of the FVC has been exhaled to the point at which 75% of the FVC has been exhaled, measured using standard spirometry techniques|30 minutes||||L/s||Full Range|Mean
2526887|NCT03628456|Primary|Forced Expiratory Volume (1 Second) Assessed in Participants at Baseline and With Both Devices|Forced Expiratory Volume in 1 second (FEV1) measures how much air a person can exhale during a forced breath during the first one (1) second, measured using standard spirometry techniques|30 minutes||||L||Full Range|Mean
2526890|NCT03628456|Primary|Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices|Tidal Volume is the normal volume of air displaced between normal inhalation and exhalation, measured using standard sprirometry techniques|30 minutes||||L||Full Range|Mean
2526891|NCT03628417|Other Pre-specified|The Tertiary Outcome is to Register if Calcium Affects the Current Strength in Electroporation Treatments.|We measured the maximum electric current which was given to the metastases. The measurement was needed because the current is unknown during Ca-electroporation, and also we would like to determine wether there is a difference between bleomycin based electrochemotherapy and calcium electroporation in current.|Day 0 - During Ca-electroporation and bleomycin based electrochemotherapy interventions||||Amper|cutaneous metastases|Full Range|Median
2526892|NCT03628417|Secondary|Adverse Events for Calcium Electroporation and Bleomycin Based Electrochemotherapy. The Adverse Reactions Are Classified According to CTCAE Version 4.0 (Common Terminology Criteria for Adverse Events).|"Adverse Event, AE: Any adverse events in a patient that occur or worsen during the trial and does not necessarily have a causal relationship to study treatment~Adverse Reaction, AR: All noxious and unintended reactions to a trial drug at any dose (possible relation between the study drug and the adverse reaction cannot be excluded)~Unexpected Adverse Reaction, UAR: An adverse reaction with a nature or severity that is not in accordance with the current product information (Investigator's Brochure)~Serious Adverse Event, SAE: an event or side effect that at any dose:~Results in death~Is life threatening~Leads to hospitalization or prolongation of hospital stay~Results in persistent or significant disability or incapacity~Leads to a congenital anomaly or birth defect~Is a major medical event~Suspected Unexpected Serious Adverse Reactions, SUSARs: adverse reactions that are not described in the product information for the experimental drug"|180 days after treatment||||cutaneous metastases|cutaneous metastases||Number
2526893|NCT03628417|Primary|Response Rate (RECIST1.1) of Calcium Electroporation and Bleomycin Based Electrochemotherapy on Cutaneous Metastases at Day 180.|"Documentation was done with digital color photography, including a ruler to estimate tumor size. Primary evaluation of the response was based on criteria similar RECIST 1.1 guidelines and defined as complete response (CR) - disappearance of the lesion, partial response (PR) - at least 30% decrease in the largest diameter of the lesion, progressive disease - at least 20% increase in the largest diameter of the lesion and stable disease - neither 30% decrease nor 20% increase of the largest diameter of the lesion.~Change in the largest diameter:"|180 days after treatment|There were 7 patients with a total of 44 cutaneous metastases which were randomized. We chose up to 10 tumours on each patient. At the first 6 tumours we examined the clinical response rate, and (if they had more) the rest 4 were used for biopsy. 33 from the 44 lesions were evaluated in clinical response, the rest were used for biopsy.|||cutaneous metastases|cutaneous metastases||Number
2526894|NCT03626714|Primary|Terminal Elimination Half-life [t1/2]|The apparent terminal elimination half-life was calculated.|60 days||||hours||Standard Deviation|Mean
2526895|NCT03626714|Primary|Blood Concentration-time Curve [AUC]|Area under the concentration-time curve|60 days||||hour*ng/mL||Standard Deviation|Mean
2526896|NCT03626714|Primary|Mean Blood Concentration-time Curve - Tmax|Time to maximum observed tacrolimus whole blood concentration|60 days||||Hour||Standard Deviation|Mean
2526897|NCT03626714|Primary|Mean Blood Concentration-time Curve - Cmax|Maximum observed tacrolimus whole blood concentration|60 days||||ng/mL||Standard Deviation|Mean
2526898|NCT03626714|Primary|Drug Concentrations in Blood Samples at Individual Time-points|The concentrations of tacrolimus in blood samples were measured at baseline, day 1 (1 hr, 3 hrs, 6 hrs, 12 hrs, and 24 hrs), followed by days 3, 7, 14, 21, 30, 37, 44, 51 and 60.|60 days||||ng/mL||Standard Deviation|Mean
2526899|NCT03626714|Primary|Number of Subjects That Experienced Treatment-related Adverse Events [Safety and Tolerability]|"Adverse events were documented at each study visit according to the criteria set forth in the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials as follows:~Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (potentially life-threatening)."|60 days||||Participants|||Count of Participants
2526900|NCT03623035|Secondary|Number of Participants Reporting Pin Prick Sensation|Assessment for spinal resolution below the level of L5/S1 by assessing the presence of pin prick sensation at these levels.|6 Hours post block placement|Number of patients who had pin prick sensation at the level of L5/S1 6 hours after nerve block and spinal placement.|||Participants|||Count of Participants
2526901|NCT03623035|Secondary|Patient Pain Scores at Rest|Pain scores will be measured, when the patient is laying still in bed, on a verbal pain scale. Totals Score range 0-10. Lower scores denote better outcomes.|6 Hours post block placement||||units on a scale||Standard Deviation|Mean
2526902|NCT03623035|Primary|Patient Pain Score With Activity|Pain scores will be measured on a verbal pain score when participant sits up in bed. Totals Score range 0-10. Lower scores denote better outcomes.|6 Hours post block placement||||units on a scale||Standard Deviation|Mean
2526903|NCT03621878|Primary|Knee Flexion Range of Motion (Asymptomatic Side)|Change in Knee flexion range of motion during slump (Asymptomatic side)|"The measurements were taken at days 0,1,5,12"||||degrees||Standard Deviation|Mean
2526904|NCT03621878|Primary|Hip Flexion Range of Motion (Asymptomatic Side)|Change in Hip Flexion Range of Motion During Straight Leg Raising (Asymptomatic Side)|"The measurements were taken at days 0,1,5,12"||||degrees||Standard Deviation|Mean
2526905|NCT03621878|Primary|Knee Flexion Range of Motion (Symptomatic Side)|Change in Knee flexion range of motion during slump (symptomatic side)|"The measurements were taken at days 0,1,5,12"||||degrees||Standard Deviation|Mean
2526906|NCT03621878|Primary|Hip Flexion Range of Motion (Symptomatic Side)|Change in Hip flexion range of motion during straight leg raising (symptomatic side)|"The measurements were taken at days 0,1,5,12"||||degrees||Standard Deviation|Mean
2526907|NCT03621878|Primary|Visual Analog Scale|Visual analog scale was used to measure pain intensity. This scale is a 10 cm line where patients chose from 0 to 10 (when 0 mean no pain and 10 mean maximum pain)|"The measurements were taken at days 0,1,5,12"||||Centimeters||Standard Deviation|Mean
2526908|NCT03620708|Secondary|Readiness to Quit Ladder|"Readiness to Quit Ladder (with 10 non-numbered choices, ranging from 0 to 10 reflecting varying degrees of readiness to quit smoking; higher numbers reflect greater readiness to quit smoking)"|30 days||||score on a scale||Standard Deviation|Mean
2546966|NCT02915029|Secondary|Serum Total Cholesterol|Change in total cholesterol on study|12 months minus baseline values||||mg/dl||Standard Deviation|Mean
2526909|NCT03620708|Secondary|Importance, Confidence, & Readiness Questionnaire|"Motivation and Self-efficacy for quitting smoking measured via Importance, Confidence, & Readiness Questionnaire (rated on a 0 to 10 scale with higher numbers indicating greater importance, confidence, or readiness to quit)"|30 days||||score on a scale||Standard Deviation|Mean
2526910|NCT03620708|Secondary|Self-reported Cigarettes Per Day|Self-reported cigarettes smoked per day; abstinence to be biochemically verified with carbon monoxide < 5ppm|30 days||||cigarettes/day||Standard Deviation|Mean
2526911|NCT03620708|Primary|Self-reported Treatment Seeking Measured Via the 'Quitting Preparation and Actions Questionnaire'|Self-reported contact with one of two treatment referrals provided at intervention since the time of the initial study appointment|30 days||||Participants|||Count of Participants
2526912|NCT03620708|Primary|Self-reported Serious Quit Attempt Measured Via the 'Quitting Preparation and Actions Questionnaire'|"A self-described serious attempt to quit smoking cigarettes since the initial study appointment, measured by the Quitting Preparation and Actions Questionnaire."|30 days||||Participants|||Count of Participants
2526913|NCT03620383|Primary|Radial Artery Cross Sectional Area|Radial artery cross sectional area after 20 minutes with or without heat application|20 minutes after application of topical heat||||mm^2||Standard Deviation|Mean
2526914|NCT03619889|Secondary|Changes of Pain Pressure Thresholds Superficial Masseter|An algometer Wagner Force One FDX 50 was used, measured in kgf/cm^2, with 0 representing the lowest pain pressure threshold/worst outcome and as higher pain pressure threshold/ as a better outcome.|Change from baseline in the scale at post-treatment and at 3 months later||||kgf/cm^2||Standard Deviation|Mean
2526915|NCT03619889|Secondary|Changes of Pain Pressure Thresholds Sternal Sternocleidomastoid|An algometer Wagner Force One FDX 50 was used, measured in kgf/cm^2, with 0 representing the lowest pain pressure threshold/worst outcome and as higher pain pressure threshold/ as a better outcome.|Change from baseline in the scale at post-treatment and at 3 months later||||kgf/cm^2||Standard Deviation|Mean
2526916|NCT03619889|Secondary|Changes of Pain Pressure Thresholds Upper Trapezius|An algometer Wagner Force One FDX 50 was used, measured in kgf/cm^2, with 0 representing the lowest pain pressure threshold/worst outcome and as higher pain pressure threshold/ as a better outcome.|Change from baseline in the scale at post-treatment and at 3 months later||||kgf/cm^2||Standard Deviation|Mean
2526917|NCT03619889|Secondary|Changes in the Trait Depression|The State-Trait Depression Inventory was used, lower values represent a better outcome. State and Trait were evaluated individually, range of scores for each subtest is 20-80, with 20 representing no Trait Depression/best outcome and 80 representing the highest level of Trait Depression/worst outcome|Change from baseline in the scale at post-treatment and at 3 months later||||units on a scale||Standard Deviation|Mean
2526918|NCT03619889|Secondary|Changes in the Trait Anxiety|The State-Trait Anxiety Index was used, lower values represent a better outcome. State and Trait were evaluated individually, range of scores for each subtest is 20-80, with 20 representing no trait anxiety/best outcome and 80 representing the highest level of trait anxiety/worst outcome.|Change from baseline in the scale at post-treatment and at 3 months later||||units on a scale||Standard Deviation|Mean
2526919|NCT03619889|Secondary|Changes in the State Depression|The State-Trait Depression Inventory was used, lower values represent a better outcome. State and Trait were evaluated individually, range of scores for each subtest is 20-80, with 20 representing no state depression/best outcome and 80 representing the highest level of state depression/worst outcome|Change from baseline in the scale at post-treatment and at 3 months later||||units on a scale||Standard Deviation|Mean
2526920|NCT03619889|Secondary|Changes in the State Anxiety|The State-Trait Anxiety Index was used, lower values represent a better outcome. State and Trait were evaluated individually, range of scores for each subtest is 20-80, with 20 representing no state anxiety/best outcome and 80 representing the highest level of state anxiety/worst outcome.|Change from baseline in the scale at post-treatment and at 3 months later||||units on a scale||Standard Deviation|Mean
2526921|NCT03619889|Secondary|Changes in the Catastrophizing|The Pain Catastrophizing Scale was used (0-52), with 0 representing no catastrophizing/best outcome and 52 representing the highest level of catastrophizing/worst outcome.|Change from baseline in the scale at post-treatment and at 3 months later||||units on a scale||Standard Deviation|Mean
2526922|NCT03619889|Secondary|Changes in the Kinesiophobia|The Tampa Scale for Kinesiophobia -11 was used (0-44), with 0 representing no kinesiophobia/best outcome and 44 representing the highest level of kinesiphobia/worst outcome.|Change from baseline in the scale at post-treatment and at 3 months later||||units on a scale||Standard Deviation|Mean
2526923|NCT03619889|Secondary|Changes in the Neck Disability|The Neck Disability Index was used (0-50), with 0 representing no disability neck/best outcome and 50 maximum disability neck/worst outcome.|Change from baseline in the scale at post-treatment and at 3 months later||||units on a scale||Standard Deviation|Mean
2526924|NCT03619889|Secondary|Changes in the Range of the Opening of the Mouth|A calibrator Dentaurum München was used, measured in millimetres, with 0 representing no opening/worst outcome and as higher values/as a better outcome.|Change from baseline in the scale at post-treatment and at 3 months later||||mm||Standard Deviation|Mean
2526925|NCT03619889|Secondary|Changes of Pain Pressure Thresholds Anterior Temporalis|An algometer Wagner Force One FDX 50 was used, measured in kgf/cm^2, with 0 representing the lowest pain pressure threshold/worst outcome and as higher pain pressure threshold/ as a better outcome.|Change from baseline in the scale at post-treatment and at 3 months later||||kgf/cm^2||Standard Deviation|Mean
2526926|NCT03619889|Primary|Changes of Perceived Pain Between Three Time Points (Baseline, Post-treatment, and 3 Months Later) and Between Groups (Sham Simulation and Pressure Release Technique)|"The Visual Analogue Scale (0-10) was used, 0 representing no pain/better outcome, and 10 representing unbearable pain/worst outcome.~the clinical minimum relevance outcome is at least a change of 1.2 points in the scale."|Change from baseline in the scale at post-treatment and at 3 months later||||units on a scale||Standard Deviation|Mean
2526982|NCT03614078|Primary|Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement|Following 12 weeks of treatment. The Psoriasis Area and Severity Index (PASI) scores the severity of disease on a scale from 0 to 72 (where a score of 72 indicates extreme disease severity). PASI 75 indicates 75% improvement from baseline to Week 12 in the Psoriasis Area and Severity Index|Baseline to week 12|Intent to treat population|||Participants|||Count of Participants
2526927|NCT03619590|Primary|Number of Outcomes From Pregnancies With Reported Exposure During an Unspecified Trimester|"Participants were followed from registration upon exposure to Twinrix during unspecified trimester of pregnancy until data on pregnancy outcome was obtained. Follow-up via telephone or a form mailed to the contact was sought in the month of the estimated date of delivery.~Pregnancy outcomes were stratified by the trimester of exposure, with an additional stratum for preconception exposure with no subsequent administration during pregnancy; multiple exposures were classified by the earliest trimester of exposure. Gestational weeks were counted from the date of the last menstrual period. The second trimester was considered to begin at week 14, and the third trimester beginning at week 28. Pregnancy outcomes were dichotomized according to the presence or absence of birth defects and further categorized as: Live births, Spontaneous abortions (i.e., pregnancy losses), Induced abortions and Fetal deaths."|From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)|Analysis was performed on the outcomes reported for the pregnancies with exposure to Twinrix within 28 days prior to conception or at any time during pregnancy. A total of 105 outcomes were reported for 103 pregnancies due to 2 sets of twins, one each from pregnancies with reported exposure during the first trimester and an unspecified trimester.|||Pregnancy Outcomes|||Number
2526928|NCT03619590|Primary|Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Third Trimester|"Participants were followed from registration upon exposure to Twinrix during third trimester of pregnancy until data on pregnancy outcome was obtained. Follow-up via telephone or a form mailed to the contact was sought in the month of the estimated date of delivery.~Pregnancy outcomes were stratified by the trimester of exposure, with an additional stratum for preconception exposure with no subsequent administration during pregnancy; multiple exposures were classified by the earliest trimester of exposure. Gestational weeks were counted from the date of the last menstrual period. The second trimester was considered to begin at week 14, and the third trimester beginning at week 28. Pregnancy outcomes were dichotomized according to the presence or absence of birth defects and further categorized as: Live births, Spontaneous abortions (i.e., pregnancy losses), Induced abortions and Fetal deaths."|From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)|Analysis was performed on the outcomes reported for the pregnancies with exposure to Twinrix within 28 days prior to conception or at any time during pregnancy. A total of 105 outcomes were reported for 103 pregnancies due to 2 sets of twins, one each from pregnancies with reported exposure during the first trimester and an unspecified trimester.|||Pregnancy Outcomes|||Number
2526929|NCT03619590|Primary|Number of Outcomes From Pregnancies With Earliest Reported Exposure During the Second Trimester|"Participants were followed from registration upon exposure to Twinrix during second trimester of pregnancy until data on pregnancy outcome was obtained. Follow-up via telephone or a form mailed to the contact was sought in the month of the estimated date of delivery.~Pregnancy outcomes were stratified by the trimester of exposure, with an additional stratum for preconception exposure with no subsequent administration during pregnancy; multiple exposures were classified by the earliest trimester of exposure. Gestational weeks were counted from the date of the last menstrual period. The second trimester was considered to begin at week 14, and the third trimester beginning at week 28. Pregnancy outcomes were dichotomized according to the presence or absence of birth defects and further categorized as: Live births, Spontaneous abortions (i.e., pregnancy losses), Induced abortions and Fetal deaths."|From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)|Analysis was performed on the outcomes reported for the pregnancies with exposure to Twinrix within 28 days prior to conception or at any time during pregnancy. A total of 105 outcomes were reported for 103 pregnancies due to 2 sets of twins, one each from pregnancies with reported exposure during the first trimester and an unspecified trimester.|||Pregnancy Outcomes|||Number
2526930|NCT03619590|Primary|Number of Outcomes From Pregnancies With Earliest Reported Exposure During the First Trimester|"Participants were followed from registration upon exposure to Twinrix during first trimester of pregnancy until data on pregnancy outcome was obtained. Follow-up via telephone or a form mailed to the contact was sought in the month of the estimated date of delivery.~Pregnancy outcomes were stratified by the trimester of exposure, with an additional stratum for preconception exposure with no subsequent administration during pregnancy; multiple exposures were classified by the earliest trimester of exposure. Gestational weeks were counted from the date of the last menstrual period. The second trimester was considered to begin at week 14, and the third trimester beginning at week 28. Pregnancy outcomes were dichotomized according to the presence or absence of birth defects and further categorized as: Live births, Spontaneous abortions (i.e., pregnancy losses), Induced abortions and Fetal deaths."|From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)|Analysis was performed on the outcomes reported for the pregnancies with exposure to Twinrix within 28 days prior to conception or at any time during pregnancy. A total of 105 outcomes were reported for 103 pregnancies due to 2 sets of twins, one each from pregnancies with reported exposure during the first trimester and an unspecified trimester.|||Pregnancy Outcomes|||Number
2526943|NCT03617523|Primary|Geometric Mean Titers of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine|GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5.|Day 21 (post-vaccination)|Analysis was performed on per-protocol analysis set.|||titers (1/dilutions)||95% Confidence Interval|Geometric Mean
2526944|NCT03617523|Primary|Geometric Mean Titers (GMTs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine|GMT of anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage.|28 days post-final vaccination|Analysis was performed on per-protocol analysis set which included participants who received at least 1 dose of the study vaccine and had a valid post-vaccination blood sample result for at least 1 strain without any protocol deviations.|||titers (1/dilution)||95% Confidence Interval|Geometric Mean
2528463|NCT03508050|Secondary|Expiratory Volume at Pleural Opening|A measure of the expiratory volume (EV) at pleural opening|From pleural opening and lasting 60 seconds||||ml||Standard Deviation|Mean
2526931|NCT03619590|Primary|Number of Outcomes From Pregnancies With Reported Exposure Within 28 Days of Last Menstrual Period|"Participants were followed from registration upon exposure to Twinrix within 28 days prior to conception until data on pregnancy outcome was obtained. Follow-up via telephone or a form mailed to the contact was sought in the month of the estimated date of delivery.~Pregnancy outcomes were stratified by the trimester of exposure, with an additional stratum for preconception exposure with no subsequent administration during pregnancy; multiple exposures were classified by the earliest trimester of exposure. Gestational weeks were counted from the date of the last menstrual period. The second trimester was considered to begin at week 14, and the third trimester beginning at week 28.~Pregnancy outcomes were dichotomized according to the presence or absence of birth defects and further categorized as: Live births, Spontaneous abortions (i.e., pregnancy losses), Induced abortions and Fetal deaths."|From the date of registration until the date of documentation of pregnancy outcome (up to 10 months i.e. 28 days prior to conception till the month of estimated date of delivery)|Analysis was performed on the outcomes reported for the pregnancies with exposure to Twinrix within 28 days prior to conception or at any time during pregnancy. A total of 105 outcomes were reported for 103 pregnancies due to 2 sets of twins, one each from pregnancies with reported exposure during the first trimester and an unspecified trimester.|||Pregnancy Outcomes|||Number
2526932|NCT03619135|Primary|Change in Anxiety|Anxiety is measured on a 10 point visual analog scale with 0 being no anxiety and 10 being the worst anxiety imaginable. A higher score is a worse outcome.|Baseline and after IV access||||score on a scale||Standard Deviation|Mean
2526933|NCT03619135|Primary|Change in Pain|Pain is measured on a 10 point visual analog scale with 0 being no pain and 10 being the worst pain imaginable. A higher score is a worse outcome.|Baseline and after IV access||||score on a scale||Standard Deviation|Mean
2526934|NCT03618628|Primary|Peak Plantar Pressure|Plantar pressure during walking while the participant wears the brace fabricated based on the finite element (FE) model compared to 1) the brace fabricated based on current clinical standards and 2) barefoot.|Participant was tested in new brace (based on FE model) after wearing for 1 week.||||Newtons per squared centimeters|||Number
2526935|NCT03618147|Primary|Number of Overall and New Cases of PID Per 100,000 Kuwaitis||15 years||||Cases per 100,000 Kuwaiti|||Number
2526936|NCT03618147|Primary|Number of Participants With Different Epidemiological Features||15 years|PID patients|||patients|||Number
2526937|NCT03617523|Primary|Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5|Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Group 3 and 4, and using an HAI assay for 3 strains: A/H1N1, A/H3N2, and B Victoria lineage in Group 5. Seroconversion was defined as either a pre-vaccination titer <10 (1/dilution) and a post-vaccination titer >= 40 (1/dilution) or a pre-vaccination titer >= 10 (1/dilution) and >=4-fold increase in post-vaccination titer.|Day 21 (post-vaccination)|Analysis was performed on per-protocol analysis set.|||percentage of participants||95% Confidence Interval|Number
2526938|NCT03617523|Primary|Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Group 1 and 2|Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Seroconversion was defined as either a pre-vaccination titer <10 (1/dilution) and a post-final vaccination titer >= 40 (1/dilution) or a pre-vaccination titer >= 10 (1/dilution) and >=4-fold increase in post-final vaccination titer.|28 days post-final vaccination|Analysis was performed on per-protocol analysis set. Here, ‘Overall number of participants analyzed’ = participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2526939|NCT03617523|Primary|Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine or Fluzone High Dose Vaccine: Group 3, 4 and 5|Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5. Seroprotection was defined as antibody titer >=40 (1/dilution) at pre-vaccination and at post-final vaccination.|Day 21 (post-vaccination)|Analysis was performed on per-protocol analysis set.|||percentage of participants||95% Confidence Interval|Number
2526940|NCT03617523|Primary|Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With Fluzone Quadrivalent Vaccine: Groups 1 and 2|Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. Seroprotection was defined as antibody titer >=40 (1/ dilution) at pre-vaccination and at post-final vaccination.|28 days post-final vaccination|Analysis was performed on per-protocol analysis set.|||percentage of participants||95% Confidence Interval|Number
2526941|NCT03617523|Primary|Geometric Mean Titer Ratios of Antibodies in Adults (Groups 3, 4 and 5) Receiving Either Fluzone Quadrivalent Vaccine, Flublok Quadrivalent Vaccine, or Fluzone High-Dose Vaccine|GMTs of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage in Groups 3 and 4, and using HAI assay for 3 strains: A/H1N1, A/H3N2 and B Victoria lineage in Group 5. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.|Day 0 (pre-vaccination), Day 21 (post-vaccination)|Analysis was performed on per-protocol analysis set.|||ratio||95% Confidence Interval|Geometric Mean
2526942|NCT03617523|Primary|Geometric Mean Titer Ratios (GMTRs) of Antibodies in Children 6 Months to <9 Years of Age (Groups 1 and 2) Receiving Fluzone Quadrivalent Vaccine|GMT of anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, and B Yamagata lineage. GMTRs were calculated as the ratio of GMTs post-final vaccination and pre-vaccination.|Day 0 (pre-vaccination), 28 days post-final vaccination|Analysis was performed on per-protocol analysis set. Here, ‘Overall number of participants analyzed’ = participants evaluable for this outcome measure.|||ratio||95% Confidence Interval|Geometric Mean
2526945|NCT03617523|Primary|Number of Participants (Groups 2, 3, 4 and 5: Children Aged 3 to <9 Years and Adults 18 to >=65 Years) Reporting Solicited Injection Site Reactions or Systemic Reactions|A solicited reaction was an AE that was pre-listed in the eCRF and considered to be related to vaccination. Solicited injection site reactions: pain, erythema and swelling. Solicited systemic reactions: fever, headache, malaise, and myalgia.|Within 7 days post any vaccination|Analysis was performed on safety analysis set.|||Participants|||Count of Participants
2526946|NCT03617523|Primary|Number of Participants (Group 1: Aged 6 to <36 Months) Reporting Solicited Injection Site Reactions and Systemic Reactions|A solicited reaction was an adverse event (AE) that was pre-listed in the electronic case report form (eCRF) and considered to be related to vaccination. Solicited injection (Inj.) site reactions: tenderness, erythema and swelling. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost and irritability.|Within 7 days post any vaccination|Analysis was performed on safety analysis set. Here, ‘Overall number of participants analyzed’ = participants evaluable for this outcome measure.|||Participants|||Count of Participants
2526947|NCT03617419|Other Pre-specified|Number of Device Issues/Complaints Reported by Site|Device Issues, Complaints, and Malfunctions will be reported in a table (type and number)|Three weeks (estimated study duration)||||Device Malfunctions|||Number
2526948|NCT03617419|Other Pre-specified|Number of Scan Operators Who Completed Surveys Regarding Usability of Vscan Access R2 Device|Series of nine questions regarding usability, ease of use, and workflow|10 minute survey completed by scan operators upon completion their participation (only one day per user)|Device Operators|||Completed Usability Surveys|||Number
2526949|NCT03617419|Other Pre-specified|Number of Adverse Events (AE/SAE) Reported During Study|Summary of type and number of AEs, SAEs reported/recorded during course|Collected from the time subject signs informed consent form to the time of completion of subject's scan session, estimated up to 4 hours||||AEs / SAEs Reported|||Number
2526950|NCT03617419|Secondary|GE Voluson P8 Confirmation of Visualization of Fetal Heart With Yes/No Answer Per Subject|Visualization of fetal heart as acquired from the GE Voluson P8 to verify that the fetal heart was correctly identified during the image acquisition using Vscan Access R2. This is gathered through a Yes/No confirmation by device operator as to whether it was the fetal heart being scanned (once for each subject).|1 day - Up to 45 minutes of total scan time (5 minutes for this specific measurement)|Subjects in Part 1 (2) and Part 2 (14)|||"Yes responses"|||Number
2526951|NCT03617419|Primary|Difference in Fetal Heart Rate as Measured by VScan Access R2 and Corometrics|Absolute difference and variance in fetal heart rate (in BPM) measured using VScan Access R2 and Corometrics|1 day - Up to 45 minutes of total scan time||||Beats Per Minute (BPM)||Standard Deviation|Mean
2526952|NCT03616977|Secondary|Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp Following Administration of Each Study Arm|GD: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure. During the euglycemic clamp procedure, blood glucose concentrations are held constant after the administration of study treatment by adjusting the exogenous glucose infusion rate.|Period 1 through 4 Day 1: Predose, every 10 minutes(m) for 30m prior to dosing; During clamp: every 2.5m for 30m; every 5m for 30 to 120m; every 10m for 120 to 480m, and every 20m for 480m to 600m postdose|All participants who received at least one dose of study drug and have evaluable glucodynamic data.|||milligram per kilogram (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
2526953|NCT03616977|Primary|Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours(h) (AUC [0-10h]) Following Administration of Each Study Arm|Pharmacokinetics (PK): Insulin Lispro AUC time zero to 10 hours.|Period 1 through 4 Day 1: Predose, 5 minutes(m),10m,15m, 20m, 25m, 30m, 35m, 40m, 45m, 50m, 55m, 60m, 70m, 90m, 120m,150m,180m, 240m, 300m, 360m, 420m, 480m, 540m, and 600m postdose|All participants who received at least one dose of study drug and had evaluable PK data.|||picomole times hour per liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2526954|NCT03616600|Primary|Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)|measured by OCULUS Keratograph® 5M|Baseline, 1st Month, 3rd Month||||Second||Standard Deviation|Mean
2526955|NCT03616600|Primary|Anterior Ocular Health in Terms of Limbal and Bulbar Redness|measured by OCULUS Keratograph® 5M and graded by JENVIS redness grading system It is a scale of 0 to 4, the higher the score, the more redness the ocular surface manifests|Baseline, 1st Month, 3rd Month||||units on a scale||Standard Deviation|Mean
2526956|NCT03616600|Primary|Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size|measured by specular microscope|Baseline, 1st Month, 3rd Month||||percentage||Standard Deviation|Mean
2526957|NCT03616600|Secondary|Reduction of the Refractive Power After Wearing the Breath-O-correct Lens|Refractive errors were determined by subjective refraction for treatment group (Breath-O correct lens wearer), the outcome was represented as mean spherical equivalent refraction with unit in diopter (SER, = 1/2 Cylindrical power + spherical power)|Baseline, 1st Week, 1st Month, 3rd Month|It is a comparison of refractive errors before-and-after treatment and therefore only the refractive errors in treatment group in different time points were compared.|||Diopter||Standard Deviation|Mean
2526958|NCT03616600|Secondary|Best Corrected Visual Acuity in Terms of High and Low Contrast|The best corrected visual acuity was measured in LogMAR (Snellen 20/20 vision = 0.00 in LogMAR ; each readable letter add -0.02 to the score, the smaller the number i.e. more negative, the better visual acuity)|Baseline, 1st Month and the 3rd Month|It is a comparison of visual performance before-and-after treatment and therefore only the best corrected visual acuity in treatment group in different time points were compared.|||LogMAR||Standard Deviation|Mean
2526959|NCT03616600|Primary|Corneal Endothelial Health in Terms of Endothelial Cell Density|measured by specular microscope|Baseline, 1st Month, 3rd Month||||cell/mm^2||Standard Deviation|Mean
2526960|NCT03616600|Primary|Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor|measured by ocular response analyser|Baseline, 1st Month, 3rd Month||||mmHg||Standard Deviation|Mean
2526961|NCT03616171|Secondary|Number of Participants Extending Sleep|Sleep extension is assessed as the number of participants extending their nightly sleep by 1 to 2 hours from the baseline visit to the week 4 visit, as monitored using wrist actigraphy to measure each participant's 24-hour sleep-wake cycle to obtain average sleep duration (total sleep time) over one week.|Over a 1 week period at Baseline, and over a 1 week period at Week 4||||Participants|||Count of Participants
2526962|NCT03616171|Secondary|Hours of Sleep|Using wrist actigraphy, this study will objectively monitor each participant's 24-hour sleep-wake cycle to obtain average sleep duration (total sleep time) over one week.|Over a 1 week period at Baseline, and over a 1 week period at Week 4||||hours||Standard Deviation|Mean
2528325|NCT03519243|Secondary|AUC(0-∞)|Area under the concentration curve from the moment of injection to infinity|3, 6, 12, 24, 48, 72, 96, 168, 336, 504, 672 h h after injection 1, weeks 5, 9, 13, 17, 21||||(mmol/L)*h||Inter-Quartile Range|Median
2526963|NCT03616171|Secondary|Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Scores|The HOMA-IR score is used to measure severity of insulin resistance, though normal insulin resistance varies depending on the population. HOMA-IR is calculated as blood glucose level (nmol/L) multiplied by insulin level (microU/L), divided by 22.5. Elevated values indicate insulin resistance. A cutoff score of HOMA-IR < 2.1 is considered normal and HOMA-IR ≥ 2.1 is considered to be evidence of insulin resistance.|Baseline, Week 4||||HOMA-IR score||Standard Deviation|Mean
2526964|NCT03616171|Primary|Number of Participants Enrolled in the Intervention Arm Who Complete the Study|Feasibility of the SLEEP-Extend intervention among young adults is measured by number of participants enrolled in the intervention arm that received the intervention and completed the study required protocols for the study duration of 4 weeks.|Week 4|Only participants in the intervention arm are included in this analysis.|||Participants|||Count of Participants
2526965|NCT03616171|Primary|Number of Enrollments in the Study Over One Year|Feasibility of the study is assessed by number of enrollments in the study over a one year period. Study proposes to enroll minimum 20 subjects to meet the feasibility of the study.|Up to 12 months||||Participants|||Count of Participants
2526966|NCT03615534|Secondary|Adverse Events|"Assessments comprise the total number of participants complicating and reporting muscle pain,flushing, nausea, vomiting, and dizziness.~As part of the complete safety profile of each arm,other specific reported adverse event are presented in the Adverse Event Module."|Changes from baseline were assessed at the end of the eighth week of treatments.||||Participants|||Count of Participants
2526967|NCT03615534|Secondary|Changes in Systolic and Diastolic Blood Pressure|Assessments involve the measurement of systolic and diastolic blood pressure. Patients were allowed to rest for 15 minutes in sitting position, and Walgreens Homedics WGNBPA-540 upper arm blood pressure monitor (Walgreens, China), was used for the measurement of blood pressure. Three consecutive readings were taken at 1 minute interval, and systolic and diastolic blood pressure were calculated as the mean of the last two readings.|Changes from baseline were assessed at the end of the eighth week of treatments.||||mmHg||Standard Error|Mean
2526968|NCT03615534|Secondary|Changes in Serum Enzymes Levels|Assessments involve the measurement of serum enzymes including Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) levels.|Changes from baseline were assessed at the end of the eighth week of treatments.||||IU/L||Standard Error|Mean
2526969|NCT03615534|Secondary|Changes in Serum Uric Acid Levels|Assessments involve the measurement of serum uric acid levels|Changes from baseline were assessed at the end of the eighth week of treatments.||||mg/dl||Standard Error|Mean
2526970|NCT03615534|Secondary|Changes in Estimated Glomerular Filtration Rate (eGFR)|Assessments involve the measurement of serum creatinine which is used to calculate eGFR using the CKD-EPI equation (2009) .|Changes from baseline were assessed at the end of the eighth week of treatments.||||ml/min per 1.73 m^2||Standard Error|Mean
2526971|NCT03615534|Secondary|Changes in Serum Fasting Glucose Levels.|Assessments involve the measurement of serum fasting glucose levels.|Changes from baseline were assessed at the end eighth week of treatments.||||mg/dl||Standard Error|Mean
2526972|NCT03615534|Primary|Changes in Serum Apolipoprotein Levels|Assessments involve the measurement of serum Apolipoprotein A1 (Apo A1) and B (Apo B) levels.|Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.||||mg/dl||Standard Error|Mean
2526973|NCT03615534|Primary|Changes in Serum Lipoprotein Cholesterol Levels|"Assessments involve the measurement of serum Total (TC), High density lipoprotein (HDL-C) and direct Low density lipoprotein (d-LDL-C) cholesterol levels.~Serum non HDL-C levels is calculated by subtracting HDL-C from TC. Serum Remnant cholesterol (RC) is calculated by subtracting HDL-C and d-LDL-C from TC."|Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.||||mg/dl||Standard Error|Mean
2526974|NCT03615534|Primary|Changes Serum Triglyceride Levels|Assessments involve the measurement of serum Triglyceride (TG) level.|Treatments effects were assessed by two events, baseline investigations conducted before randomization and end line investigations at the end of the eighth week of treatments.||||mg/dl||Standard Error|Mean
2526975|NCT03614975|Secondary|Determining Geometric Mean Titers (GMTs) at Each Time Point|Hemagglutination inhibition assay will be conducted to assess immunologic outcome. GMTs is defined as the anti-log of the mean of the log2 HI titers|Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)||||Dilution||95% Confidence Interval|Geometric Mean
2526976|NCT03614975|Secondary|Determining Seroprotection Level at Each Time Point|Hemagglutination inhibition assay will be conducted to assess immunologic outcome. Seroprotection is defined as a HI titer >= 1:110 at either time point.|Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)|Data was analyzed on participants who completed day 21 visit.|||Participants|||Count of Participants
2526977|NCT03614975|Primary|Determining Seroconversion Response - Change in HI Titers From Pre- to Post Vaccination|Hemagglutination inhibition (HI) assay will be conducted to assess immunologic outcome. Seroconversion is defined as a 4-fold or higher rise in HI titer post-vaccination given a pre-vaccination HI titer of >= 10.|Pre-vaccination (at Day 0 timepoint) and post-vaccination (at Day 21 timepoint)|Participants who completed study through day 21|||Participants|||Count of Participants
2526978|NCT03614078|Secondary|Time to Reach Maximum Observed Drug Concentration (Tmax)|Steady state after 12 weeks of treatment|Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84|Pharmacokinetic (PK) evaluable|||hours||Full Range|Median
2526979|NCT03614078|Secondary|Maximum Observed Drug Concentration (Cmax)|Steady state after 12 weeks of treatment|Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84|Pharmacokinetic (PK) evaluable|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2526980|NCT03614078|Secondary|Area Under the Concentration Time Curve (AUC0-τ)|Steady state after 12 weeks of treatment|Predose and 1, 2, 4, 8, 336, 672, 1008, 1344 hours post dose, on Day 84|Pharmacokinetic (PK) evaluable|||h*mg/mL||Geometric Coefficient of Variation|Geometric Mean
2526981|NCT03614078|Secondary|Number of Participants With Any Treatment Emergent Adverse Event|Following 12 weeks of treatment|Baseline up to week 18|Safety population|||Participants|||Count of Participants
2528326|NCT03519243|Secondary|AUC(0-672 Hour)|Area under the concentration curve from the moment of injection to 672 h [28 days])|3, 6, 12, 24, 48, 72, 96, 168, 336, 504, 672 h h after injection 1||||(mmol/L)*h||Inter-Quartile Range|Median
2526983|NCT03613649|Secondary|Changes From Baseline in ECG Measures: Ventricular Rate|Change from baseline in ECG Ventricular Rate is calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, 24 h after dosing and prior to the next dose (follow up).|Baseline, 1 h, 2 h, 4h, 24 h post-dose and follow up|Any participants who received study product and had post dose ECG assessments.|||beats/minute||Standard Deviation|Mean
2526984|NCT03613649|Secondary|Changes From Baseline in ECG Measures: PR Interval, QRS Duration, QT Interval, QTcF Interval and RR Interval|Change from baseline in ECG is calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, 24 h after dosing and prior to the next dose (follow up). The following ECG Parameters were analyzed: PR Interval (Interval From Onset of P-wave to the Onset of the QRS Complex), QRS Duration (Time From the Start of the Q-wave to the End of the S-wave), QT Interval (Interval From Onset of the Q-wave to the End of the T-wave), QTcF Interval (QT Interval Corrected by Fridericia's Formula) and RR Interval (Interval From the Peak of the R Wave of a QRS Complex to the Peak of the R Wave of the Next QRS Complex).|Baseline, 1 h, 2 h, 4h, 24 h post-dose and follow up|Any participants who received study product and had post dose ECG assessments.|||milliseconds (msec)||Standard Deviation|Mean
2526985|NCT03613649|Secondary|Occurrence of Urinalysis Adverse Events Following Administration of Study Product|Urine for the clinical laboratory test was collected on Day -1, 24 hour post dose and the check in for the following dosing period. The results for glucose dipstick, protein dipstick and occult blood - dipstick were reported in categorical results. The possibilities were negative, trace, 1+, 2+, and 3+. If the dipsticks were 1+ or greater, microscopic evaluations were performed for erythrocytes, leukocytes and bacteria. For microscopic results to be deemed abnormal, the results must be reported 6 or greater per high power field.|From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit).|Any participants who received study product and had post dose laboratory assessments.|||Participants|||Count of Participants
2526986|NCT03613649|Secondary|Changes From Baseline for Glomerular Filtration Rate (GFR) - Estimated|Change from baseline calculated by subtracting the Day -1 (baseline) chemistry measurement from the 24 h post dose, and a follow up chemistry measurement. Follow up is defined as either the check-in visit for the next period or the final visit.|Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).|Any participants who received study product and had post dose laboratory assessments.|||mL/minute||Standard Deviation|Mean
2526987|NCT03613649|Secondary|Changes From Baseline for Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (AP)|Change from baseline calculated by subtracting the Day -1 (baseline) chemistry measurement from the 24 h post dose, and a follow up chemistry measurement. Follow up is defined as either the check-in visit for the next period or the final visit. Chemistry parameters included AST, ALT and AP.|Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).|Any participants who received study product for that dosing period and had post dose laboratory assessments.|||U/L||Standard Deviation|Mean
2526988|NCT03613649|Secondary|Changes From Baseline for Total Protein and Albumin|Change from baseline calculated by subtracting the Day -1 (baseline) chemistry measurement from the 24 h post dose, and a follow up chemistry measurement. Follow up is defined as either the check-in visit for the next period or the final visit. Chemistry parameters included total protein and albumin.|Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).|Any participants who received study product for that dosing period and had post dose laboratory assessments.|||g/dL||Standard Deviation|Mean
2526989|NCT03613649|Secondary|Changes From Baseline for Magnesium, Glucose (Fasting), Blood Urea Nitrogen (BUN), Creatinine, Total Bilirubin, Direct Bilirubin|Change from baseline calculated by subtracting the Day -1 (baseline) chemistry measurement from the 24 h post dose, and a follow up chemistry measurement. Follow up is defined as either the check-in visit for the next period or the final visit. Chemistry parameters included magnesium, glucose (fasting), BUN, creatinine, total bilirubin, direct bilirubin|Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).|Any participants who received study product for that dosing period and had post dose laboratory assessments.|||mg/dL||Standard Deviation|Mean
2526990|NCT03613649|Secondary|Changes From Baseline for Sodium, Potassium, Chloride and Bicarbonate|Change from baseline calculated by subtracting the Day -1 (baseline) chemistry measurement from the 24 h post dose, and a follow up chemistry measurement. Follow up is defined as either the check-in visit for the next period or the final visit. Chemistry parameters included sodium, potassium. chloride and bicarbonate.|Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).|Any participants who received study product for that dosing period and had post dose laboratory assessments.|||mmol/L||Standard Deviation|Mean
2526991|NCT03613649|Secondary|Changes From Baseline for Platelets|Change from baseline for platelets is calculated by subtracting the Day -1 (baseline) hematology measurement from the 24 h post dose, and a follow up hematology measurement. Follow up is defined as either the check-in visit for the next period or the final visit.|Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).|Any participants who received study product for that dosing period and had post dose laboratory assessments.|||10^3 platelets/microliter||Standard Deviation|Mean
2526992|NCT03613649|Secondary|Changes From Baseline for Erythrocytes|Change from baseline for erythrocytes is calculated by subtracting the Day -1 (baseline) hematology measurement from the 24 h post dose, and a follow up hematology measurement. Follow up is defined as either the check-in visit for the next period or the final visit.|Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).|Any participants who received study product and had post dose laboratory assessments.|||10^6 cells/microliter||Standard Deviation|Mean
2526993|NCT03613649|Secondary|Changes From Baseline for Hematocrit|Change from baseline for hematocrit is calculated by subtracting the Day -1 (baseline) hematology measurement from the 24 h post dose, and a follow up hematology measurement. Follow up is defined as either the check-in visit for the next period or the final visit.|Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).|Any participants who received study product and had post dose laboratory assessments.|||volume percentage of RBC in blood||Standard Deviation|Mean
2527044|NCT03608839|Secondary|Best Corrected Visual Acuity (BCVA) at 28 Days After Intravitreous Dexamethasone|Measure best corrected visual acuity (BCVA) at 28 days after intravitreous dexamethasone with ETDRS chart|28 days after intravitreous dexamethasone||||ETDRS letters||Standard Deviation|Mean
2526994|NCT03613649|Secondary|Changes From Baseline for Hemoglobin|Change from baseline for hemoglobin is calculated by subtracting the Day -1 (baseline) hematology measurement from the 24 h post dose, and a follow up hematology measurement. Follow up is defined as either the check-in visit for the next period or the final visit.|Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).|Any participants who received study product and had post dose laboratory assessments.|||g/dL||Standard Deviation|Mean
2526995|NCT03613649|Secondary|Changes From Baseline for White Blood Cells With Differentials|Change from baseline calculated by subtracting the Day -1 (baseline) hematology measurement from the 24 h post dose, and a follow up hematology measurement. Follow up is defined as either the check-in visit for the next period or the final visit. Hematology parameters included white blood cell count, and differential (absolute counts of neutrophils, lymphocytes, monocytes, eosinophils, and basophils).|Prior to dosing, 24 hour post dose through prior to the next dose (Day 8 or Final visit).|Any participants who received study product and had post dose laboratory assessments.|||cells/microliter||Standard Deviation|Mean
2526996|NCT03613649|Secondary|Changes From Baseline for Temperature|Change from baseline for temperature was calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h and 24 h after dosing. Follow up is defined as the check in visit for the next dosing period or the final visit.|From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit).|Any participants who received study product and had post dose assessments.|||Celsius||Standard Deviation|Mean
2526997|NCT03613649|Secondary|Changes From Baseline for Respiratory Rate|Change from baseline in respiratory rate was calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h and 24 h after dosing. Follow up is defined as the check in visit for the next dosing period or the final visit.|From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit).|Any participants who received study product and had post dose assessments.|||breaths/minute||Standard Deviation|Mean
2526998|NCT03613649|Secondary|Changes From Baseline for Pulse Rate|Change from baseline in pulse rate was calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h and 24 h after dosing. Follow up is defined as the check in visit for the next dosing period or the final visit.|From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit).|Any participants who received study product and had post dose assessments.|||beats/minute||Standard Deviation|Mean
2526999|NCT03613649|Secondary|Changes From Baseline for Blood Pressure - Diastolic|Change from baseline in diastolic blood pressure was calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h and 24 h after dosing. Follow up is defined as the check in visit for the next dosing period or the final visit.|From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit).|Any participants who received study product and had post dose assessments.|||mmHg||Standard Deviation|Mean
2527000|NCT03613649|Secondary|Changes From Baseline for Blood Pressure - Systolic|Change from baseline in systolic blood pressure was calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h and 24 h after dosing. Follow up is defined as the check in visit for the next dosing period or the final visit.|From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit).|Any participants who received study product and had post dose assessments.|||mmHg||Standard Deviation|Mean
2527001|NCT03613649|Secondary|Number of Participants With Treatment-emergent Adverse Events Following Administration of Study Product|Adverse events are defined as any untoward medical occurrence regardless of its causal relationship to the study treatment.|From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit).|Any participants who received study product.|||Participants|||Count of Participants
2527002|NCT03613649|Secondary|Number of Participants With Treatment-emergent Serious Adverse Events Following Administration of Zoliflodacin and Moxifloxacin|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect.|From study product administration (Day 1) through prior to the next dose (Day 8 or Final visit).|Any participants who received study product.|||Participants|||Count of Participants
2527003|NCT03613649|Secondary|Relationship Between Plasma Concentrations of Zoliflodacin and Time-matched, Placebo-corrected, Baseline-adjusted Mean QTcF Interval (Delta Delta QTcF) Following Administration of Zoliflodacin|One-sided 95% confidence intervals of population mean QTcF time-matched, placebo-corrected, baseline-adjusted mean QTcF interval at plasma concentration corresponding to the observed geometric mean Cmax for 2 g and 4 g doses of zoliflodacin were computed using a linear mixed effect model with PK and concentration data collected at baseline and intervals post-dose.|Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose|Any participants who received study product and had post dose assessments.|||milliseconds (msec)||95% Confidence Interval|Mean
2527004|NCT03613649|Secondary|Terminal Elimination Half-life (t1/2) of Zoliflodacin|The apparent terminal elimination half-life (t1/2) was defined as the time required for the drug concentration to decrease by a factor of one-half in the terminal phase computed from concentrations that were measured using a validated HPLC-MS/MS method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose.|Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose||||Hour||Standard Deviation|Mean
2527005|NCT03613649|Secondary|Elimination Rate Constant (Ke) of Zoliflodacin|The terminal phase elimination rate constant (Ke) was defined as the first-order rate constant describing the rate of decrease of drug concentration in the terminal phase (defined as the terminal region of the PK curve where drug concentration follows first-order elimination kinetics) computed from concentrations that were measured using a validated HPLC-MS/MS method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose.|Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose||||1/hour||Standard Deviation|Mean
2527045|NCT03608839|Secondary|Best Corrected Visual Acuity (BCVA) at 3 Days After Intravitreous Dexamethasone|Measure best corrected visual acuity (BCVA) at 3 days after intravitreous dexamethasone with ETDRS chart|Three days after intravitreous dexamethasone||||ETDRS Letters||Standard Deviation|Mean
2527006|NCT03613649|Secondary|Apparent Oral Clearance (CL/F) of Zoliflodacin|Apparent oral clearance (CL/F) computed as Dose/Area under the curve (AUC) from time zero to infinity (0-infinity) computed from concentrations that were measured using a validated high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose.|Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose||||Liter/hour||Standard Deviation|Mean
2527007|NCT03613649|Secondary|Apparent Volume of Distribution (Vz/F) of Zoliflodacin|Apparent volume of distribution during terminal phase (Vz/F) after non-intravenous administration was calculated as (CL/F)/ Ke computed from concentrations that were measured using a validated HPLC-MS/MS method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose.|Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose||||Liter||Standard Deviation|Mean
2527008|NCT03613649|Secondary|Area Under the Concentration Time-curve From Time Zero to the Last Concentration Above the Lower Limit of Quantitation (AUC(0-last)) for Zoliflodacin|AUC(0-last) was defined as the area under the concentration-time curve from dosing (time 0) to the time of the last measured concentration computed from concentrations that were measured using a validated HPLC-MS/MS method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose.|Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose||||h*ng/mL||Standard Deviation|Mean
2527009|NCT03613649|Secondary|Area Under the Concentration Time-curve From Time Zero to Infinity (AUC(0 - Infinity)) for Zoliflodacin|AUC(0 - infinity) was defined as the total area under the concentration-time curve from dosing (time 0) taken to the limit as the end time becomes arbitrarily large. AUC(0 - infinity) was calculated by adding AUC(0-last) to an extrapolated value equal to the last measured concentration greater than the lower limit of quantification of the bioanalytical assay divided by the terminal phase elimination rate constant (Ke) computed from concentrations that were measured using a validated HPLC-MS/MS method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose.|Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose||||h x ng/mL||Standard Deviation|Mean
2527010|NCT03613649|Secondary|Time of Maximum Observed Concentration (Tmax) of Zoliflodacin|Tmax is defined as the time at which the maximum concentration (Cmax) occurs in plasma computed from concentrations that were measured using a validated HPLC-MS/MS method. PK parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose.|Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose||||hour||Standard Deviation|Mean
2527011|NCT03613649|Secondary|Maximum Observed Concentration (Cmax) of Zoliflodacin|Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations computed from concentrations that were measured using a validated HPLC-MS/MS method. Pharmacokinetic (PK) parameters were computed using plasma concentrations from samples collected pre-dose and intervals post-dose.|Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose||||ng/mL||Standard Deviation|Mean
2527012|NCT03613649|Secondary|Incidence of Abnormal T-wave Morphology Following Administration of Zoliflodacin|Categorical T-wave morphology analysis was collected in three ECG replicates at each timepoint (Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose). Abnormalities present in any one or more of the baseline timepoint replicate ECGs recorded for a particular period was considered to be present at baseline for post-dose ECGs from that specific period. If a subject had an ECG morphological abnormality in more than one replicate ECG of a study timepoint, the subject was counted only once for that timepoint. Flat is defined as T amplitude <1 mm (either positive or negative) including flat isoelectric line and Biphasic is defined as T-wave that contains a second component with an opposite phase that was at least 0.1 millivolts (mV) deep (both positive and negative/positive and polyphasic T-waves included).|Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose|Any participants who received study product and had post dose assessments.|||Participants|||Count of Participants
2527013|NCT03613649|Secondary|The One-sided 95% Confidence Interval (CI) of the Time-matched, Placebo-corrected, Baseline-adjusted Mean QTcF Interval (Delta Delta QTcF) After a Single Dose of Moxifloxacin|Mean and 90% two-sided confidence intervals (t-intervals) of change from baseline QTcF intervals by time point and treatment. Note that the upper bound of the 90% two-sided confidence interval can also be interpreted as the upper bound of a 95% one-sided confidence interval.|Baseline, 1 h, 2 h, 3 h, and 4 h post-dose|Any participants who received a dose of moxifloxacin and placebo and had post dose assessments is counted in the population.|||milliseconds (msec)||95% Confidence Interval|Mean
2527014|NCT03613649|Secondary|Time-matched, Placebo-corrected, Baseline-adjusted QRS Duration Following Administration of Zoliflodacin|Mean and 90% two-sided confidence intervals (t-intervals) of change from baseline QRS durations by time point and treatment. Note that the upper bound of the 90% two-sided confidence interval can also be interpreted as the upper bound of a 95% one-sided confidence interval.|Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose|The analysis population sample size is equal to the number of subjects in the Holter ECG Analysis Population who received both a dose of zoliflodacin and a dose of placebo.|||milliseconds (msec)||95% Confidence Interval|Mean
2527015|NCT03613649|Secondary|Time-matched, Placebo-corrected, Baseline-adjusted the Time Elapsed Between Two Successive R Waves of the QRS (RR Interval) Following Administration of Zoliflodacin|Mean and 90% two-sided confidence intervals (t-intervals) of change from baseline RR intervals by time point and treatment. Note that the upper bound of the 90% two-sided confidence interval can also be interpreted as the upper bound of a 95% one-sided confidence interval.|Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose|The analysis population sample size is equal to the number of subjects in the Holter ECG Analysis Population who received both a dose of zoliflodacin and a dose of placebo.|||milliseconds (msec)||95% Confidence Interval|Mean
2527016|NCT03613649|Secondary|Time-matched, Placebo-corrected, Baseline-adjusted, the Time From the Onset of the P Wave to the Start of the QRS Complex (PR Interval) Following Administration of Zoliflodacin|Mean and 90% two-sided confidence intervals (t-intervals) of change from baseline PR intervals by time point and treatment. Note that the upper bound of the 90% two-sided confidence interval can also be interpreted as the upper bound of a 95% one-sided confidence interval.|Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose|The analysis population sample size is equal to the number of subjects in the Holter ECG Analysis Population who received both a dose of zoliflodacin and a dose of placebo.|||milliseconds (msec)||95% Confidence Interval|Mean
2527017|NCT03613649|Secondary|Time-matched, Placebo-corrected, Baseline-adjusted Heart Rate (HR) Following Administration of Zoliflodacin|Mean and 90% two-sided confidence intervals (t-intervals) of change from baseline heart rate by time point and treatment. Note that the upper bound of the 90% two-sided confidence interval can also be interpreted as the upper bound of a 95% one-sided confidence interval.|Baseline, 0.5 h, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose|The analysis population sample size is equal to the number of subjects in the Holter ECG Analysis Population who received both a dose of zoliflodacin and a dose of placebo.|||beats/minute||95% Confidence Interval|Mean
2527018|NCT03613649|Primary|The One-sided 95% Confidence Interval (CI) for the Largest Time-matched, Placebo-corrected, Baseline-adjusted Mean QTcF Interval (Delta Delta QTcF) Following Administration of Zoliflodacin|Mean and 90% two-sided confidence intervals (t-intervals) of change from baseline QTcF intervals by time point and treatment. Note that the upper bound of the 90% two-sided confidence interval can also be interpreted as the upper bound of a 95% one-sided confidence interval.|Baseline, 0.5 hour (h), 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 24 h post-dose after 2 and 4 g zolifloadacin|The analysis population sample size is equal to the number of subjects in the Holter ECG Analysis Population who received a dose of zoliflodacin or a dose of placebo.|||milliseconds (msec)||90% Confidence Interval|Mean
2527019|NCT03613493|Primary|Number of Participants That Used and Returned Their Self-sampler Kit.|Number of participants that used and returned their self-sampler kit was evaluated.|2 weeks|Data was not collected for the fear appeal message HPV self-sampling condition due to lack of funding.|||Participants|||Count of Participants
2527020|NCT03613129|Secondary|SF-36, MCS|Pre-/post-treatment difference in the mental component score (MCS) of the RAND 36-Item Health Survey (SF-36), on a 0-100 scale (where 0=max disability and 100=no disability)|Visit 1 (pre-trial), Visit 3 before treatment (pre-treatment) and at Visit 6 (post-treatment)||||units on a scale||Standard Deviation|Mean
2527021|NCT03613129|Secondary|SF-36, PCS|Pre-/post-treatment difference in the physical component score (PCS) of the RAND 36-Item Health Survey (SF-36), on a 0-100 scale (where 0=max disability and 100=no disability)|Visit 1 (pre-trial), Visit 3 before treatment (pre-treatment) and at Visit 6 (post-treatment)||||units on a scale||Standard Deviation|Mean
2527022|NCT03613129|Primary|Total Daily Symptom Score (TDSS)|Pre-/post-treatment difference in TDSS (0-65 scale, 0=no symptoms; 65=maximum of 5 for each of 13 specific patient-reported symptoms). The TDSS sums the patient-reported daily symptom score for each of 13 specific symptoms (including fatigue, muscle/joint pain, sleep problems, cognitive problems, orthostatic intolerance, body temperature perceptions, flu-like symptoms, headaches or sensitivities, shortness of breath, gastrointestinal problems, urogenital problems, anxiety and depression), each assessed on a 0-5 scale (0=no symptom, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=severe)|28 days preceding Visit 3 (pre-treatment) and 28 days preceding Visit 6 (post-treatment)||||units on a scale (0-65)||Standard Deviation|Mean
2527023|NCT03611829|Other Pre-specified|Intervention Completion Time|How long it took participants in each condition to complete the 8-session intervention|Baseline to Post-Intervention (on average, 16 weeks)||||weeks||Standard Deviation|Mean
2527024|NCT03611829|Other Pre-specified|Questionnaire Completion|Percentage of participants who completed questionnaires between conditions|Baseline to Post-Intervention (on average, 16 weeks)||||Participants|||Count of Participants
2527025|NCT03611829|Other Pre-specified|Number of Participants That Dropped Out From Study|Dropout rates between conditions from baseline to session 8.|Baseline to Post-Intervention (on average, 16 weeks)||||Participants|||Count of Participants
2527026|NCT03611829|Other Pre-specified|Recruitment Rates|Percentage of individuals who were eligible to participate in the study (based on the initial prescreen) that actually enrolled.|Prescreen questionnaire to Baseline|123 of those who completed the initial prescreen questionnaire were deemed eligible for the study and randomized to standard care (64) or ACT intervention (59). Of these, 43 and 44 participants, respectively actually began the study.|||Participants|||Count of Participants
2527027|NCT03611829|Other Pre-specified|Physician Treatment Satisfaction|"Assessed by a self-developed questionnaire with items such as ease of difficulty and required preparation time. The following questions were assessed on Likert scales from 1 (to little) to 5 (too much) with middle scores (3) reflecting perceived balance (e.g., not too difficult, the right amount of preparation time). Total score was calculated as the mean of all items."|Each physician was asked to complete this questionnaire once during their administration of the ACT intervention (from July 2016 to February 2017)|Physicians who delivered the ACT intervention were asked to provide their input on the intervention. They only completed this questionnaire in relation to the ACT intervention and not standard care.|||units on a scale||Standard Deviation|Mean
2527028|NCT03611829|Other Pre-specified|Patient Treatment Satisfaction|"Assessed by a self-developed questionnaire with items such as the program reduced my emotional eating and the program was easy to follow. Scores represent mean ratings on a 5-point Likert-type rating scale from 1 (strongly agree) to 5 (strongly disagree). Lower scores reflect higher treatment satisfaction."|Administered Post-Intervention (at on average, 16 weeks)|Of those who initiated the intervention, only 28 participants completed the treatment satisfaction questionnaire at post-intervention (session 8) to be included in the analyses.|||units on a scale||Standard Deviation|Mean
2527029|NCT03611829|Secondary|Values Clarification/ACT Application Change|"This questionnaire was developed for the present study to evaluate participants' real world application of the intervention. Participants were asked to indicate their level of agreement on a 5-point scale (1 = strongly agree and 5 = strongly disagree) to prompts such as My values motivate me to lose weight and I am able to accept negative emotions and don't have to eat when I'm feeling bad. Total score was calculated as the mean of all items. Lower scores indicate higher values clarification. Negative change scores reflect increases in ACT application and values clarification."|Baseline to Post-Intervention (on average, 16 weeks)|Of those who initiated the intervention, only 26 participants completed the ACT application at baseline and post-intervention (session 8) to be included in the analyses.|||units on a scale||95% Confidence Interval|Mean
2527046|NCT03608839|Secondary|Macular Thickness at 28 Days After Intravitreous Dexamethasone|Measure macular thickness at 28 days after intravitreous dexamethasone with OCT - unit µm|28 days after intravitreous dexamethasone||||µm||Standard Deviation|Mean
2528464|NCT03508050|Secondary|O2 Concentration of Expired Air at Pleural Opening|A measure of the O2 concentration of the expiratory air at pleural opening|From pleural opening and lasting 60 seconds||||% of oxygen||Standard Deviation|Mean
2527030|NCT03611829|Secondary|Mindfulness Awareness Change|Assessed by the Philadelphia Mindfulness Scale (PHLMS). All items were rated on a 5-point Likert scale from 1 (never) to 5 (very often). The subscale score is calculated as the sum of all items on the subscale, with the minimum possible score being 10 and the maximum possible score being 50. Higher scores reflect higher levels of awareness. Negative change scores reflect decreases in mindfulness and positive change scores reflect increases in mindfulness.|Baseline to Post-Intervention (on average, 16 weeks)|Of those who initiated the intervention, only 26 participants completed the PHLMS at baseline and post-intervention (session 8) to be included in the analyses.|||units on a scale||95% Confidence Interval|Mean
2527031|NCT03611829|Secondary|Distress Tolerance Change|Assessed by the Distress Tolerance Scale (DTS). All items were rated on a 5-point Likert scale from 1 (strongly agree) to 5 (strongly disagree). The score is calculated as the mean of all items. Higher scores reflect higher levels of distress tolerance. Positive change scores reflect increases in distress tolerance.|Baseline to Post-Intervention (on average, 16 weeks)|Of those who initiated the intervention, only 26 participants completed the DTS at baseline and post-intervention (session 8) to be included in the analyses.|||units on a scale||95% Confidence Interval|Mean
2527032|NCT03611829|Secondary|Restraint Eating Change|Assessed by the Dutch Eating Behavior Questionnaire (DEBQ) restraint eating subscale. Scores range from 1 (never) to 5 (very often). Lower scores reflect lower restraint eating. This subscale score is calculated by taking the mean of all items on the subscale. Positive change scores reflect increase in restraint eating.|Baseline to Post-Intervention (on average, 16 weeks)|Of those who initiated the intervention, only 26 participants completed the DEBQ at baseline and post-intervention (session 8) to be included in the analyses.|||units on a scale||95% Confidence Interval|Mean
2527033|NCT03611829|Secondary|External Eating Change|Assessed by the Dutch Eating Behavior Questionnaire (DEBQ) external eating subscale. Scores range from 1 (never) to 5 (very often). Lower scores reflect lower external eating. This subscale score is calculated by taking the mean of all items on the subscale. Negative change scores reflect decreases in external eating.|Baseline to Post-Intervention (on average, 16 weeks)|Of those who initiated the intervention, only 26 participants completed the DEBQ at baseline and post-intervention (session 8) to be included in the analyses.|||units on a scale||95% Confidence Interval|Mean
2527034|NCT03611829|Secondary|Body Fat Percentage Change|Change in body fat percentage|Baseline to Post-Intervention (on average, 16 weeks)|Of those who initiated the intervention, 40 individuals completed all 8 sessions and had body fat data at session 8.|||percentage of body fat||95% Confidence Interval|Mean
2527035|NCT03611829|Primary|Emotional Eating Change|Assessed by the Dutch Eating Behavior Questionnaire (DEBQ) emotional eating subscale. Scores range from 1 (never) to 5 (very often). Lower scores reflect lower emotional eating. This subscale score is calculated by taking the mean of all items on the subscale. Negative change scores reflect decreases in emotional eating.|Baseline to Post-Intervention (on average, 16 weeks)|Of those who initiated the intervention, only 26 participants completed the DEBQ at baseline and post-intervention (session 8) to be included in the analyses.|||units on a scale||95% Confidence Interval|Mean
2527036|NCT03611829|Primary|Weight Change|Weight change in kilograms|Baseline to Post-Intervention (on average, 16 weeks)|Of those who initiated the intervention, 40 individuals completed all 8 sessions and had weight data at session 8.|||kilograms||95% Confidence Interval|Mean
2527037|NCT03610633|Primary|Corticolimbic Functional Connectivity Based on fMRI Blood Oxygenation Level Dependent (BOLD) Response During the Stress Versus Neutral Conditions of the Montreal Imaging Stress Test Task Averaged Over the Second and Third Functional Runs|Corticolimbic functional connectivity will be determined using psychophysiological interaction (PPI) modeling. The left and right amygdala will serve as seed regions. Connectivity of each seed region with the homologous orbitofrontal cortex region will be represented as a parameter estimate, yielding one parameter estimate for right amygdala-right orbitofrontal connectivity and one parameter estimate for left amygdala-left orbitofrontal connectivity per subject.|60 minutes following medication (oxytocin or placebo)||||contrast of parameter estimates||Standard Deviation|Mean
2527038|NCT03610464|Primary|Plasma Concentrations of d- and L-amphetamine|Plasma Concentration of d- and l-amphetamine measured at 0, 1, 3, 4, 6, 8, 10, 12, and 28 hours postdose.|0-28 hours postdose|intention to treat population|||ng/mL||Standard Deviation|Geometric Mean
2527039|NCT03610269|Primary|Accuracy of Noninvasive Hemoglobin (SpHb) Measurement by Arms Calculation|Accuracy of the INVSENSOR00026 will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of the INVSENSOR00026 to the hemoglobin value obtained from a reference blood sample and calculating the accuracy root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the INVSENSOR00026 hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|Up to 2 hours per subject||||g/dL|||Number
2527040|NCT03609619|Secondary|Clinical Global Impression - Global Improvement (CGI -I) Response|"The CGI-I item is rated on a 7-point scale from 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse.~Response is defined as achieving a CGI-I score of 1 or 2, scores of 3 to 7 or missing are defined as Non Response"|Visit 3 to Visit 8 (Week 6)||||Participants|||Count of Participants
2527041|NCT03609619|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale, Version 5 (ADHD-RS-5) Total Score|"The ADHD-RS-5 is comprised of 18 frequency items and 12 impairment items. Each frequency item was scored on a scale from 0 = Never or rarely to 3 = Very often.~The ADHD-RS-5 total score was calculated as the sum of the 18 frequency item scores. The total score ranges from 0 to 54. Higher scores indicate greater symptom severity. Change from baseline value were calculated as the assessment value minus the baseline value."|Baseline to Visit 8 (Week 6)||||units on a scale||Standard Error|Least Squares Mean
2527042|NCT03608839|Secondary|Intraocular Pressure (IOP) at 28 Days After Intravitreous Dexamethasone|Measure intraocular pressure (IOP) 28 days intravitreous dexamethasone - unit mmHg|28 days after intravitreous dexamethasone||||mmHg||Standard Deviation|Mean
2527043|NCT03608839|Secondary|Intraocular Pressure (IOP) at 3 Days After Intravitreous Dexamethasone|Measure intraocular pressure (IOP) 3 days after intravitreous dexamethasone - unit mmHg|3 days after intravitreous dexamethasone||||mmHg||Standard Deviation|Mean
2527047|NCT03608839|Primary|Macular Thickness at 3 Days After Intravitreous Dexamethasone|Measure macular thickness at 3 days after intravitreous dexamethasone with OCT - unit µm|Three days after intravitreous dexamethasone|Macular thickness at 3 days after intravitreous dexamethasone|||µm||Standard Deviation|Mean
2527048|NCT03608488|Secondary|Health Status Assessed After Treatment (8 Weeks)|"Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.~38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.~Ovearall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status."|After treatment (8 weeks)||||score on a scale||Standard Deviation|Mean
2527049|NCT03608488|Secondary|Health Status Assessed at Baseline|"Notthingham Health Profile: general patient reported outcome measure which measures subjective health status.~38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores.~Ovearall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status"|Baseline||||score on a scale||Standard Deviation|Mean
2527050|NCT03608488|Secondary|Fall Risk Assesment Performed After Treatment (8 Weeks)|Biodex fall risk screening test: Patients were instructed to maintain the vertical projection with their center of gravity in the midpoint of the platform 0° is the best possible value, higher score reflects increased risk of falling. But there is no defined maximum score.|After treatment (8 weeks)||||score||Standard Deviation|Mean
2527051|NCT03608488|Secondary|Fall Risk Assesment Performed at Baseline|Biodex fall risk screening test: Patients were instructed to maintain the vertical projection with their center of gravity in the midpoint of the platform 0 is the best possible value, higher score reflects increased risk of falling. But there is no defined maximum score|Baseline||||score||Standard Deviation|Mean
2527052|NCT03608488|Primary|Berg Balance Test Assessed After Treatment (8weeks)|14-item scale designed to measure balance of the older adult in a clinical setting minimum: 0 maximum: 56 A score of 56 indicates functional balance. A score of < 45 indicates individuals may be at greater risk of falling.|After treatment (8 weeks)||||score on a scale||Standard Deviation|Mean
2527053|NCT03608488|Primary|Berg Balance Test Assessed at Baseline|14-item scale designed to measure balance of the older adult in a clinical setting minimum: 0 maximum: 56 A score of 56 indicates functional balance. A score of < 45 indicates individuals may be at greater risk of falling.|Baseline||||score on a scale||Standard Deviation|Mean
2527054|NCT03608488|Primary|Postural Stability Test (Biodex) Assessed After Treatment (8 Weeks)|"overall stability index: quantifying the ability to maintain dynamic postural stability.~The patient's score on this test assesses deviations from center, thus a lower score is more desirable than a higher score.~Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System 0 is the minimum score, but there is no defined maximum score"|After treatment (8 weeks)||||score||Standard Deviation|Mean
2527055|NCT03608488|Primary|Postural Stability Test (Biodex) Assessed at Baseline|"overall stability index: quantifying the ability to maintain dynamic postural stability The patient's score on this test assesses deviations from center, thus lower index means less instability and better balance.~Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.~0 is the minimum score, but there is no defined maximum score"|Baseline||||score||Standard Deviation|Mean
2527056|NCT03605303|Primary|Overall Vision Score|Subjective assessment of vision will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.|1-Week Follow-up|Study terminated early. No data was analyzed.||||||
2527057|NCT03605303|Primary|Overall Comfort Scores|Subjective assessment of comfort will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.|1-Week Follow-up|Study terminated early. No data was analyzed.||||||
2527058|NCT03604341|Primary|Maximum Self-reported Pain Score on a Numeric Rating Scale|Women will text responds to surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain using an 11-point numeric rating scale (NRS 0-10) where 0=no pain and 10=worst possible pain.|24 hours after misoprostol administration||||score on a scale||Inter-Quartile Range|Median
2527059|NCT03603106|Primary|PK Parameter Vd|Vd = volume of distribution. Blood samples were taken to assess the P03277 concentration.|From baseline (30 minutes before injection) to 24 hours post-injection|"In part I, one patient from the 0.025 mmol/kg group was excluded from the pharmacokinetics analysis (incorrect volume of P03277 injected).~In part II, one patient from the 0.1 mmol/kg group was excluded from the pharmacokinetics analysis (incorrect route of administration, high probability of extravasation)."|||mL||Standard Deviation|Mean
2527060|NCT03603106|Primary|PK Parameter Cl|Cl = total clearance. Blood samples were taken to assess the P03277 concentration.|From baseline (30 minutes before injection) to 24 hours post-injection|"In part I, one patient from the 0.025 mmol/kg group was excluded from the pharmacokinetics analysis (incorrect volume of P03277 injected).~In part II, one patient from the 0.1 mmol/kg group was excluded from the pharmacokinetics analysis (incorrect route of administration, high probability of extravasation)."|||mL/min||Standard Deviation|Mean
2528721|NCT03491553|Secondary|Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24||Baseline, Week 24|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2527061|NCT03603106|Primary|PK Parameter T1/2|T1/2 = terminal elimination half-life of the compound. Blood samples were taken to assess the P03277 concentration.|From baseline (30 minutes before injection) to 24 hours post-injection|"In part I, one patient from the 0.025 mmol/kg group was excluded from the pharmacokinetics analysis (incorrect volume of P03277 injected).~In part II, one patient from the 0.1 mmol/kg group was excluded from the pharmacokinetics analysis (incorrect route of administration, high probability of extravasation)."|||hours||Standard Deviation|Mean
2527062|NCT03603106|Primary|Pharmacokinetic (PK) Parameter Cmax|Cmax = maximum concentration measured. Blood samples were taken to assess the P03277 concentration.|From baseline (30 minutes before injection) to 24 hours post-injection|"In part I, one patient from the 0.025 mmol/kg group was excluded from the pharmacokinetics analysis (incorrect volume of P03277 injected).~In part II, one patient from the 0.1 mmol/kg group was excluded from the pharmacokinetics analysis (incorrect route of administration, high probability of extravasation)."|||µg/mL||Standard Deviation|Mean
2527063|NCT03603028|Secondary|Walking Speed|How fast participants walk while playing the game by dividing the distance people walked by the amount of time that they walked|Day 1 - Day 3 of study|One participant withdrew from the study|||meters per second||Standard Deviation|Mean
2527064|NCT03603028|Primary|Walking Distance|How far participants walk while playing the game as measured by a meter on the instrumented treadmill.|Day 1 through Day 3 of study|One participant withdrew from the study|||meters||Standard Deviation|Mean
2527065|NCT03601715|Secondary|Heat Conservation|Determinate which capacitance shortwave technique retain the induced heat for longer time. The skin temperature will be verified by infrared thermography before the application and after during 25 minutes, 1 minutes apart each measure. This evaluation will occur in three 24 hours apart visits, each for one of the three capacitance shortwave technique.|3 days|Occurred 2 losses to follow up.|||Celsius||Standard Deviation|Mean
2527066|NCT03601715|Secondary|Temperature Increase|Determine which capacitance shortwave technique will increase the temperature the most after 20 minutes of application. The skin temperature will be verified by infrared thermography. This evaluation will occur in three 24 hours apart visits, each for one of the three capacitance shortwave technique.|3 days|Occurred 2 losses to follow up.|||Celsius||Standard Deviation|Mean
2527067|NCT03601715|Primary|The Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared Thermography|Evaluation of the most effective electrode arrangement (coplanar, contraplanar or longitudinal) in relation to temperature increase and heat conservation. Measured using a infrared camera in three sessions, with a washout period of at least 24 hours.|3 days|Occurred 2 losses to follow up.|||Celsius||Standard Deviation|Mean
2527068|NCT03599349|Secondary|The Depth of Submental Tissue Layers Will be Compared to the Quantitative Measurement of Lift in the Lower Face Regions to Determine if There is or is Not a Correlation|The depth of the following submental tissue layers; dermis, subq adipose/fibrous septae, supraplatysmal fascia, platysma and subplatysmal fascia will be compared to the quantitative measurement of lift in the lower face regions to determine if there is or is not a correlation.|Day 90 and 180 post-treatment|Quantitative assessment of lift was not performed. Lack of consistency and usability of pre- and post-treatment images and inconsistencies in head positioning of the subjects. A correlation analysis could therefore not be performed.||||||
2527069|NCT03599349|Secondary|The Depth of Cheek Tissue Layers Will be Compared to the Quantitative Measurement of Lift in the Lower Face Regions to Determine if There is or is Not a Correlation.|The depth of the following cheek tissue layers; dermis, subq adipose/fibrous septae, and SMAS will be compared to the quantitative measurement of lift in the lower face regions to determine if there is or is not a correlation.|Day 90 and 180 post-treatment|Quantitative assessment of lift was not performed due to lack of consistency and usability of pre- and post-treatment images and inconsistencies in head positioning of the subjects. A correlation analysis could therefore not be performed.||||||
2527070|NCT03599349|Secondary|The Depth of the Temple Region Tissue Layers Will be Compared to the Quantitative Measurement of Lift the Eyebrow Region to Determine if There is or is Not a Correlation.|The depth of the following temple region tissue layers; dermis, subq adipose/fibrous septae, SMAS and temporalis muscle will be compared to the quantitative measurements of lift in the eyebrow region to determine if there is or is not a correlation.|Day 90 and 180 post-treatment|Quantitative assessment of lift was not performed due to lack of consistency and usability of pre- and post-treatment images and inconsistencies in head positioning of the subjects. A correlation analysis could therefore not be performed.||||||
2527071|NCT03599349|Secondary|The Depth of Frontal Region Tissue Layers Will be Compared to the Quantitative Measurements of Lift in the Eyebrow Region to Determine if There is or is Not a Correlation.|The depth of the following frontal region tissue layers; dermis, subq adipose/fibrous septae, suprafrontalis fascia, frontalis muscle and subfrontalis fascia will be compared to the quantitative measurement of lift in the eyebrow region to determine if there is or is not a correlation|Day 90 and 180 post-treatment|Quantitative assessment of lift was not performed due to lack of consistency and usability of pre- and post-treatment images and inconsistencies in head positioning of the subjects. A correlation analysis could therefore not be performed.||||||
2527072|NCT03599349|Secondary|The Subject Will Complete a Patient Satisfaction Questionnaire at the 90 and 180 Day Follow-up Visits Which Will be Compared to Average SMAS and Average Dermal Thickness of the Treated Areas to Determine if There is or is Not a Correlation|The subject will complete a patient satisfaction questionnaire at the 90 and 180 day follow-up visits which will be compared to average SMAS and average dermal thickness of the treated areas to determine if there is or is not a correlation.|Day 90 and 180 post-treatment|A total of 20 subjects were enrolled and treated. Of these, data on this secondary outcome was available for 20 subjects at day 90 and for 19 subjects at day 180. Correlation was analyzed for the overall duration of the study (including both D90 and D180 data).|||Correlation coefficient|||Number
2527100|NCT03590613|Secondary|Time to Maximum Observed Plasma Drug Concentration (Tmax) of Each TID Doses for One Day of GSK2982772|Blood samples were collected from participants at indicated time points and Tmax was analyzed after the administration of TID doses of GSK2982772.|Pre-dose,20 and 40 minutes, 1, 1.5, 2, 3, 5, 7 hours,7 hours 20 minutes,7 hours 40 minutes,8, 8.5, 9, 10, 12, 14 hours,14 hours 20 minutes,14 hours40 minutes, 15, 15.5, 16, 17, 19, 22, 24, 28, 32, 36, 48, 60 and 72 hours post-dose at each Treatment Period|Pharmacokinetic Population.|||Hours||Full Range|Median
2527073|NCT03599349|Secondary|Qualitative Assessment of Overall Aesthetic Improvement Will be Compared to the Average SMAS and Average Dermal Thickness of the Treated Areas to Determine if There is or is Not a Correlation|"Degree of overall aesthetic improvement determined by a masked, qualitative assessment of photographs at 90 and 180 days post-treatment compared to baseline, based on level of clearance/improvement. The percent improvement will be compared to the average SMAS and average dermal thickness of the treated areas to determine if there is or is not a correlation.~Level of improvement scale:~0 = 0% Improvement (None)~1 = < 25% Improvement (Mild)~2 = 26 to 50% Improvement (Moderate)~3 = 51 to 75% Improvement (Significant)~4 = 76 to 100% Improvement (Very Significant)"|Day 90 and 180 post-treatment|A total of 20 subjects were enrolled and treated. Of these, data on this secondary outcome was available for 20 subjects at day 90 and for 19 subjects at day 180. Correlation was analyzed for the overall duration of the study (including both D90 and D180 data).|||Correlation coefficient|||Number
2527074|NCT03599349|Secondary|The Subject Will Complete a SGAIS Assessing Overall Aesthetic Improvement at Day 90 and 180 Post-treatment Which Will be Compared to Average SMAS and Average Dermal Thickness of the Treated Areas to Determine if There is or is Not a Correlation|The subject will complete a SGAIS assessing overall aesthetic improvement at day 90 and 180 post-treatment which will be compared to average SMAS and average dermal thickness of the treated areas to determine if there is or is not a correlation.|Day 90 and 180 post-treatment|SGAIS data was not collected. A correlation analysis could therefore not be performed.||||||
2527075|NCT03599349|Secondary|Comparison of CGAIS Ratings to Average SMAS and Average Dermal Thickness of the Treated Areas to Determine if There is or is Not a Correlation.|The Principal Investigator, sub-investigator or qualified clinician delegated by the principal investigator, will complete a CGAIS assessing overall aesthetic improvement at day 90 and 180 post-treatment. The CGAIS will be compared to average SMAS and average dermal thickness of the treated areas to determine if there is or is not a correlation.|Day 90 and 180 post-treatment|CGAIS data was not collected. A correlation analysis could therefore not be performed.||||||
2527076|NCT03599349|Primary|Determine if There is a Correlation Between D90 Quantitative Efficacy Results of the Eyebrow and Lower Face Region With Where the TCPs Produced During Ultherapy Treatment Make Contact With Anatomical Layers of the Skin and Underlying Tissues.|TCP = Thermal Coagulation Points. The average Superficial Musculo-Aponeurotic System (SMAS) depth in the eyebrow and lower face regions (cheeks, submental and submandibular) will be compared to quantitative measurement of lift in the eyebrow and submental/neck lift at day 90 post-treatment|Day 90 post treatment|Quantitative assessment of lift was not performed due to lack of quality of pre- and post-treatment images and inconsistencies in head positioning of the subjects. A correlation analysis could therefore not be performed.||||||
2527077|NCT03597178|Primary|Overall Success Rate of Insertion and Removal of a Contact Lens|The subject attempted to insert a contact lens in each eye. The subject were allowed to voluntarily end the contact lens insertion activity at any time prior to the 20-minute time point. The time of insertion for each eye or the time of stopping the insertion process for each eye was recorded. Similarly, the time of removal for each lens or the time of stopping the removal process for each lens was recorded.|Lens insertion and Removal, up to 2-Hours|All subjects who successfully ompleted all study visits and did not substanially deviate from the protocol as deterined by the trial cohort review committee prior to database lock.|||Percentage of eyes|Eyes||Number
2527078|NCT03596723|Secondary|Modified Global Overall Assessment of Postoperative Inflammation|"The Modified Global Overall Assessment is a way of quantifying the amount of post operative healing that has occurred. Lower values indicate greater healing.The Modified Global Assessment grading uses whole numbers from 0 (clear) to 2 (not improving or worsening) as follows:~0 = clear~= improving satisfactorily~= not improving or worsening"|Day 15||||Participants|||Count of Participants
2527079|NCT03596723|Primary|Anterior Chamber Cell Grade|"Anterior chamber cell grading is a way of quantifying the amount of inflammation in inflammatory eye processes. Higher values indicate greater inflammation. The anterior chamber cell grading uses whole numbers from 0 (no cells) to 4 (> 30 cells) as follows:~Anterior chamber cell grade 0 = no cells seen Anterior chamber cell grade 1 = 1 - 5 cells Anterior chamber cell grade 2 = 6 - 15 cells Anterior chamber cell grade 4 = greater than 30 cells"|Day 15||||Participants|||Count of Participants
2527080|NCT03595215|Secondary|Change in Quality of Life (QoL)|Improvement in incontinence QoL scores compared to pre-treatment|Baseline and 8 weeks|||||||
2527081|NCT03595215|Secondary|Change in Micturitions Per Day||Baseline and 8 weeks|||||||
2527082|NCT03595215|Primary|Change in Urge Incontinence Episodes||Baseline and 8 weeks||||UUI||Standard Deviation|Mean
2527083|NCT03592121|Primary|Change in Delayed Orgasm Grade|"Change in Delayed Orgasm Grade (CTCAE v4.0 - Common Terminology of Adverse Events) CTCAE v4.0 is the NIH Common Terminology of Adverse Events v4.0~Delayed Orgasm is defined as: A disorder characterized by sexual dysfunction characterized by a delay in climax.~This is a binary grading system:~Grade 0:Delay in achieving orgasm not adversely affecting relationship Grade 1:Delay in achieving orgasm adversely affecting relationship"|[baseline, week 8]|We were unable to recruit a sufficient number of subjects.|||Grade||Standard Deviation|Mean
2527084|NCT03591458|Secondary|Hypoglycemia Fear Survey Score|Participants will complete the Hypoglycemia Fear Survey for hypoglycemia fear assessment at the baseline and final Intervention Phase visit. The Hypoglycemia Fear Survey is comprised of 33 questions to evaluate the hypoglycemia awareness. The answer for each individual question will represent a score (0 to 4). These scores will be summed together to a final score from 0 to 132, representing from normal to minimal/no hypoglycemia awareness. The average change in Hypoglycemia Fear Survey questionnaire score from baseline to end of treatment will be compared between the Amitriptyline and Placebo arms.|10 Weeks|No analysis conducted due to small sample size; study terminated due to low enrollment||||||
2527085|NCT03591458|Secondary|Hypoglycemia Awareness Score by Pedersen-Bjergaard Questionnaire|"Participants will complete the Pedersen-Bjergaard questionnaire for hypoglycemia awareness at the baseline and final Intervention Phase visit. The Pederson-Bjergaard questionnaire is comprised of one question to evaluate the hypoglycemia awareness, with answers of Always, sometimes, occasionally, never or Do not know. Each answer will represent an awareness status. The change in Pedersen-Bjergaard questionnaire status from baseline to end of treatment will be compared between the Amitriptyline and Placebo arms."|10 Weeks|No analysis conducted due to small sample size; study terminated due to low enrollment||||||
2527086|NCT03591458|Secondary|Hypoglycemia Awareness Score by Clarke Questionnaire|Participants will complete the Clarke questionnaire for hypoglycemia awareness at the baseline and final Intervention Phase visit. The Clarke questionnaire is comprised of eight questions to evaluate the hypoglycemia awareness. The answer for each individual question will represent a score (0 or 1). These scores will be summed together to a final score from 0 to 7, representing from normal to minimal/no hypoglycemia awareness. The average change in Clarke questionnaire score from baseline to end of treatment will be compared between the Amitriptyline and Placebo arms.|10 Weeks|No analysis conducted due to small sample size; study terminated due to low enrollment||||||
2527087|NCT03591458|Secondary|Hypoglycemia Awareness Score by Gold Questionnaire|Participants will complete the Gold questionnaire for hypoglycemia awareness at the baseline and final Intervention Phase visit. The Gold questionnaire is comprised of one question to evaluate the hypoglycemia awareness, with scores from 1 to 7, representing from normal to minimal/no hypoglycemia awareness. The average change in Gold questionnaire score from baseline to end of treatment will be compared between the Amitriptyline and Placebo arms.|10 Weeks|No analysis conducted due to small sample size; study terminated due to low enrollment||||||
2527088|NCT03591458|Secondary|Average Hypoglycemia Duration With Blood Glucose < 54 mg/dL|Continuous Glucose Monitoring (CGM) data will be collected for a 2-week period at the end of the Intervention Phase. The duration of hypoglycemic episodes for glucose values < 54 mg/dL will be averaged compared between the Amitriptyline and Placebo arms.|2 weeks|No analysis conducted due to small sample size; study terminated due to low enrollment||||||
2527089|NCT03591458|Secondary|Average Hypoglycemia Duration With Blood Glucose < 70 mg/dL|Continuous Glucose Monitoring (CGM) data will be collected for a 2-week period at the end of the Intervention Phase. The duration of hypoglycemic episodes for glucose values < 70 mg/dL will be averaged compared between the Amitriptyline and Placebo arms.|2 weeks|No analysis conducted due to small sample size; study terminated due to low enrollment||||||
2527090|NCT03591458|Secondary|Hypoglycemia Episode Count With Blood Glucose < 54 mg/dL|Continuous Glucose Monitoring (CGM) data will be collected for a 2-week period at the end of the Intervention Phase. The number of hypoglycemic episodes for glucose values < 54 mg/dL will be compared between the Amitriptyline and Placebo arms.|2 weeks|No analysis conducted due to small sample size; study terminated due to low enrollment||||||
2527091|NCT03591458|Secondary|Hypoglycemia Episode Count With Blood Glucose < 70 mg/dL|Continuous Glucose Monitoring (CGM) data will be collected for a 2-week period at the end of the Intervention Phase. The number of hypoglycemic episodes for glucose values < 70 mg/dL will be compared between the Amitriptyline and Placebo arms.|2 weeks|No analysis conducted due to small sample size; study terminated due to low enrollment||||||
2527092|NCT03591458|Secondary|Total Count of Severe Hypoglycemic Episodes|Severe hypoglycemic episodes, defined by the need from other to administer treatments for hypoglycemia, as reported by patients will be counted and totaled during the Intervention Phase.|8 Weeks|No analysis conducted due to small sample size; study terminated due to low enrollment||||||
2527093|NCT03591458|Primary|Ratio of Self-Reported Hypoglycemic Episodes to Total Hypoglycemic Episodes|Participants will complete a report of all hypoglycemic events experienced during the 2-week surveillance period at the end of the Intervention Phase. The average ratio of self-reported hypoglycemic episodes to total hypoglycemic episodes recorded by Continuous Glucose Monitoring (CGM) will be compared between the Amitriptyline and Placebo arms.|2 Weeks|No analysis conducted due to small sample size; study terminated due to low enrollment||||||
2527094|NCT03591458|Primary|Glucose Area Under the Curve (AUC): Values < 54 mg/dL|Continuous Glucose Monitoring (CGM) data will be collected for a 2-week period at the end of the Intervention Phase. The mean AUC for glucose values < 54 mg/dL will be compared between the Amitriptyline and Placebo arms.|2 Weeks|No analysis conducted due to small sample size; study terminated due to low enrollment||||||
2527095|NCT03591458|Primary|Glucose Area Under the Curve (AUC): Values < 70 mg/dL|Continuous Glucose Monitoring (CGM) data will be collected for a 2-week period at the end of the Intervention Phase. The mean AUC for glucose values < 70 mg/dL will be compared between the Amitriptyline and Placebo arms.|2 Weeks|No analysis conducted due to small sample size; study terminated due to low enrollment.||||||
2527096|NCT03590743|Secondary|Net Clinical Benefit or Harm for the Two Strategies|The outcome of net clinical benefit or harm will be assessed as the composite of the primary efficacy outcome or the principal safety outcome up to day 90. The difference in the incidences of the combined endpoint at 3 months between treatment arms will be estimated and tested using a normal approximation of the binomial distribution. All tests will be conducted at the two-sided 0.05 significance level.|Within 3 months of therapy initiation.|Study terminated to due lack of subject enrollment. Data was not analyzed.||||||
2527097|NCT03590743|Secondary|Mean Time of Thrombus Propagation|The timing of thrombus propagation for those individuals who have suffered such an event. The date of thrombus propagation confirmation will be compared to the date of the original Deep Vein Thrombosis (DVT) diagnosis for this purpose.|Within 3 months of therapy initiation|Study terminated due to lack of subject enrollment. Data was not analyzed.||||||
2527098|NCT03590743|Primary|Number of Subjects Who Experience Either Major Bleeding or Clinically Relevant Non-major Bleeding Within 3 Months|"Major bleeding is defined as overt bleeding plus a hemoglobin decrease of ≥ 2 g/dL or transfusion of ≥ 2 units of packed red blood cells, or bleeding at a critical site: intracranial, intraspinal, intraocular, retroperitoneal, pericardial intra-articular, intramuscular with compartment syndrome, or fatal bleeding.~Clinically relevant non-major bleeding is defined as any overt, actionable sign of hemorrhage meeting at least one of the following criteria: (i) requiring nonsurgical, medical intervention by a healthcare professional, (ii) leading to hospitalization or increased level of care, or (iii) prompting evaluation.~All patients who received at least one dose of study medication will be included in the safety analysis. All suspected bleeding events will be evaluated by a central, blinded, independent adjudication committee."|Within 3 months of therapy initiation|Study terminate to due lack of subject enrollment. Data was not analyzed.||||||
2527099|NCT03590743|Primary|Number of Subjects Who Experience a Composite Venous Thromboembolism (VTE) Event Within 3 Months|The composite VTE event will include thrombus propagation either within the calf veins or into proximal deep veins (popliteal, femoral or iliac veins), symptomatic or incidental VTE recurrence or all-cause mortality within 3 months of therapy initiation. All suspected VTE events will be evaluated by a central, blinded, independent adjudication committee.|Within 3 months of therapy initiation|Study terminated due to lack of subject enrollment. Data was not analyzed.||||||
2527101|NCT03590613|Secondary|Terminal Half Life (t1/2) After the Third TID Dose for One Day of GSK2982772|Blood samples were collected from participants at indicated time points and t1/2 was analyzed after the administration of third TID dose of GSK2982772.|Pre-dose,20 and 40 minutes, 1, 1.5, 2, 3, 5, 7 hours,7 hours 20 minutes,7 hours 40 minutes,8, 8.5, 9, 10, 12, 14 hours,14 hours 20 minutes,14 hours40 minutes, 15, 15.5, 16, 17, 19, 22, 24, 28, 32, 36, 48, 60 and 72 hours post-dose at each Treatment Period|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2527102|NCT03590613|Secondary|Maximum Observed Plasma Concentration (Cmax) and Observed Trough Drug Plasma Concentrations Following Each TID Doses for One Day of GSK2982772|Blood samples were collected from participants at indicated time points and analyzed for Cmax and observed trough drug plasma concentrations: C0, C7, C14 and C24 after the administration of TID doses of GSK2982772.|Pre-dose,20 and 40 minutes, 1, 1.5, 2, 3, 5, 7 hours,7 hours 20 minutes,7 hours 40 minutes,8, 8.5, 9, 10, 12, 14 hours,14 hours 20 minutes,14 hours40 minutes, 15, 15.5, 16, 17, 19, 22, 24, 28, 32, 36, 48, 60 and 72 hours post-dose at each Treatment Period|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2527103|NCT03590613|Secondary|Area Under the Plasma Drug Concentration Versus Time Curve Over 24 Hours (AUC[0-24]) and AUC Over Each Dose Interval of TID Doses for One Day of GSK2982772|Blood samples were collected from participants at indicated time points and analyzed for AUC (0-24) and AUC over each dose: AUC(0-7), AUC (7-14) and AUC (14-24) after the administration of TID doses of GSK2982772. Pharmacokinetic analysis was conducted using standard non-compartmental methods. All participants in the safety population for whom a pharmacokinetic sample has been obtained and analyzed was included in the pharmacokinetic population.|Pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 5, 7 hours, 7 hours 20 minutes, 7 hours 40 minutes, 8, 8.5, 9, 10, 12, 14 hours, 14 hours 20 minutes, 14 hours 40 minutes, 15, 15.5, 16, 17, 19, 22 and 24 hours post-dose at each Treatment Period|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2527104|NCT03590613|Primary|Number of Participants With Abnormal Neurological Examinations of TID Doses for One Day of GSK2982772|Neurological examinations including: mental status, gait, balance, coordination, cranial nerves, motor power, reflexes, and sensory system (light touch and pain) were assessed in participants specified time points.|Baseline (Day -1) and at 2, 7, 14, 24, 48 and 72 hours at each Treatment Period|Safety Population.|||Participants|||Count of Participants
2527105|NCT03590613|Primary|Change From Baseline in Body Temperature of TID Doses for One Day of GSK2982772|Temperature of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 2, 7, 14, 24, 48 and 72 hours at each Treatment Period|Safety Population.|||Degrees Celsius||Standard Deviation|Mean
2527106|NCT03590613|Primary|Change From Baseline in Pulse Rate of TID Doses for One Day of GSK2982772|Pulse rate of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 2, 7, 14, 24, 48 and 72 hours at each Treatment Period|Safety Population.|||Beats per minute||Standard Deviation|Mean
2527107|NCT03590613|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 2, 7, 14, 24, 48 and 72 hours at each treatment period|Safety Population.|||Millimeters of mercury||Standard Deviation|Mean
2527108|NCT03590613|Primary|Number of Participants With Abnormal Not Clinically Significant Cardiac Telemetry|Continuous cardiac telemetry was performed and number of participants with abnormal clinically significant and not clinically significant values are presented.|Up to 24 hours at each Treatment Period|Safety Population.|||Participants|||Count of Participants
2527109|NCT03590613|Primary|Change From Baseline in ECG Findings of TID Doses for One Day of GSK2982772|Full 12-lead ECGs were recorded in participants using an automated ECG machine and measured PR, QRS, QT and QTcF intervals. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 2, 7, 14, 24, 48 and 72 hours at each Treatment Period|Safety Population.|||Milliseconds||Standard Deviation|Mean
2527110|NCT03590613|Primary|Change From Baseline in Electrocardiogram (ECG) Finding: Mean Heart Rate|Full 12-lead ECGs were recorded in participant using an automated ECG machine. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 2, 7, 14, 24, 48 and 72 hours at each Treatment Period|Safety Population.|||Beats per minute||Standard Deviation|Mean
2527111|NCT03590613|Primary|Number of Participants With Abnormal Urinalysis Results by Dipstick Method|Urine samples were collected to assess urine bilirubin, urine glucose, urine ketones, urine occult blood, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-) and trace (+-) indicating proportional concentrations in the urine sample.|At 72 hours of each Treatment Period|Safety Population.|||Participants|||Count of Participants
2527124|NCT03590613|Primary|Change From Baseline in Clinical Chemistry Parameter: Amylase|Blood samples were collected for the analysis of clinical chemistry parameter: amylase. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 72 hours at each Treatment Period|Safety Population|||Units per liter||Standard Deviation|Mean
2527112|NCT03590613|Primary|Change From Baseline in Urine Specific Gravity|Urine samples were collected for analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 72 hours at each Treatment Period|Safety Population.|||Ratio of urine density to water density||Standard Deviation|Mean
2527113|NCT03590613|Primary|Change From Baseline in Urine Potential of Hydrogen (pH)|Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 72 hours at each Treatment Period|Safety Population.|||pH||Standard Deviation|Mean
2527114|NCT03590613|Primary|Change From Baseline in Hematology Parameters of TID Doses for One Day of GSK2982772|Blood samples were collected for the analysis of hematology parameters including neutrophils/leukocytes, lymphocytes/leukocytes, monocytes/leukocytes, eosinophils/leukocytes and basophils/leukocytes. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 72 hours at each Treatment Period|Safety Population.|||Percentage of cells in leukocytes||Standard Deviation|Mean
2527115|NCT03590613|Primary|Change From Baseline in Hematology Parameters: Platelets and Leukocytes of TID Doses for One Day of GSK2982772|Blood samples were collected for the analysis of hematology parameters including platelet count and leukocytes. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 72 hours at each Treatment Period|Safety Population.|||10^9 cells per liter||Standard Deviation|Mean
2527116|NCT03590613|Primary|Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes|Blood samples were collected for the analysis of hematology parameter: percentage reticulocytes. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 72 hours at each Treatment Period|Safety Population.|||Ratio of Reticulocytes to Erythrocytes||Standard Deviation|Mean
2527117|NCT03590613|Primary|Change From Baseline in Hematology Parameter: Erythrocytes|Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 72 hours at each Treatment Period|Safety Population.|||10^12 cells per liter||Standard Deviation|Mean
2527118|NCT03590613|Primary|Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume (MCV)|Blood samples were collected for the analysis of hematology parameter: erythrocyte MCV. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 72 hours at each Treatment Period|Safety Population.|||Femtoliters||Standard Deviation|Mean
2527119|NCT03590613|Primary|Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Hemoglobin (MCH)|Blood samples were collected for the analysis of hematology parameter: erythrocyte MCH. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 72 hours at each Treatment Period|Safety Population.|||Picograms||Standard Deviation|Mean
2527120|NCT03590613|Primary|Change From Baseline in Hematology Parameter: Hemoglobin|Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 72 hours at each Treatment Period|Safety Population.|||Grams per liter||Standard Deviation|Mean
2527121|NCT03590613|Primary|Change From Baseline in Hematology Parameter: Hematocrit|Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 72 hours at each Treatment Period|Safety Population.|||Percentage of red blood cells in blood||Standard Deviation|Mean
2527122|NCT03590613|Primary|Change From Baseline in Clinical Chemistry Parameter: C-reactive Protein (CRP) of TID Doses for One Day of GSK2982772|Blood samples were collected for the analysis of clinical chemistry parameter: CRP. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 72 hours at each Treatment Period|Safety Population.|||Milligrams per liter||Standard Deviation|Mean
2527123|NCT03590613|Primary|Change From Baseline in Clinical Chemistry Parameters: Direct Bilirubin, Bilirubin, Creatinine and Urate (Uric Acid)|Blood samples were collected for the analysis of clinical chemistry parameters:direct bilirubin, bilirubin, creatinine and urate. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 72 hours at each Treatment Period|Safety Population.|||Micromoles per liter||Standard Deviation|Mean
2527225|NCT03582553|Secondary|Measurement of Four-hour Concentration of Serum Naringenin at 300 and 900 mg Doses|Blood will be drawn at 0 hours and 4 hours following ingestion of the 300 and 900mg doses of naringenin and serum naringenin concentrations will be measured.|0 and 4 hours|Subjects who participated in the study|||uM||Standard Error|Least Squares Mean
2527125|NCT03590613|Primary|Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatinine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrognase (LDH)|Blood samples were collected for the analysis of clinical chemistry parameters including: ALP, ALT, AST, CK, GGT and LDH. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 72 hours at each Treatment Period|Safety Population.|||International units per liter||Standard Deviation|Mean
2527126|NCT03590613|Primary|Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein|Blood samples were collected for the analysis of clinical chemistry parameters including: albumin and protein. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 72 hours at each Treatment Period|Safety Population.|||Grams per liter||Standard Deviation|Mean
2527127|NCT03590613|Primary|Change From Baseline in Clinical Chemistry Parameters|Blood samples were collected for the analysis of clinical chemistry parameters including: glucose, calcium, cholesterol, chloride, high density lipoprotein (HDL) cholesterol, potassium, low density lipoprotein (LDL) cholesterol, phosphate, sodium, triglycerides and urea. Baseline value was the latest pre-dose (Day -1) assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 72 hours at each treatment period|Safety Population.|||Millimoles per liter||Standard Deviation|Mean
2527128|NCT03590613|Primary|Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety population comprised of all participants who have received at least one dose of study treatment. This population was used for the safety analyses.|From the day of first dose to 39 days|Safety Population.|||Participants|||Count of Participants
2527129|NCT03588572|Secondary|Follow-up Measurement: Mini-Mental State Examination (MMSE)|The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Administration of the test takes between 5 and 10 minutes. The MMSE test includes simple questions and problems in a number of areas: the time and place of the test, repeating lists of words, arithmetic such as the serial sevens, language use and comprehension, and basic motor skills. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.The raw score may also need to be corrected for educational attainment and age.|We must determine that the participant is not in moderate or more cognitive impairment at each follow-up. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.||||score on a scale||Standard Deviation|Mean
2527130|NCT03588572|Secondary|Follow-up Measurement: Hamilton Anxiety Rating Scale (HAMA)|The Hamilton Anxiety Rating Scale (HAMA) is a widely used and well-validated tool for measuring the severity of a patient's anxiety. The HAMA is composed of 14 items and takes 15-20 minutes to complete the interview and score the results. Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe.HAMA Scoring Instructions:0-8=Normal, 8-13= Possible Anxiety, 14-17 = Mild Anxiety, 18-24 = Moderate Anxiety, 25-30 = Severe Anxiety(i.e.,the higher the score, the greater the likelihood of anxiety).|We must determine that the participant is not in anxiety at each follow-up. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.||||score on a scale||Standard Deviation|Mean
2527131|NCT03588572|Secondary|Follow-up Measurement: Hamilton Depression Rating Scale (HAMD)|The Hamilton Depression Rating Scale (HAMD) has proven useful for many years as a way of determining a patient's level of depression before, during, and after treatment. It generally takes 15-20 minutes to complete the interview and score the results. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine items are scored from 0-2. HAMD Scoring Instructions:0-7=Normal, 8-13 = Mild Depression, 14-18 = Moderate Depression, 19-22 = Severe Depression, ≥ 23 = Very Severe Depression(i.e.,Minimum 0 points and maximum 50 points, the higher the score, the greater the likelihood of depression).|We must determine that the participant is not in depression at each follow-up. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.||||score on a scale||Standard Deviation|Mean
2527132|NCT03588572|Secondary|Functional Magnetic Resonance Imaging(fMRI)|The examine included task-state fMRI and resting-state fMRI|We will explore the mechanisms of dynamic changes in language functions. Thus, participates will undergo this examine on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.||2019-12-31|12/2019||||
2527133|NCT03588572|Secondary|A Change of Outcome Measure:Picture Naming Test(PNT)|This test mainly assesses the ability of picture name of participants.we used a program for displaying named pictures on a computer screen (60 photos in total, of which 20 were Chinese celebrity faces). Each image was displayed in 3 seconds, and 1 point was correctly named for an image.The faces of celebrities were selected from the picture database of Chinese celebrities in the State Key Laboratory of Cognitive Neuroscience and Learning at Beijing Normal University.Score fluctuation is 0-60 points, the higher the score, the better the ability of picture name.|This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.||||score on a scale||Standard Deviation|Mean
2527180|NCT03585959|Secondary|Histopathological Call Based on ROSE of the ENB-aided Tissue Sample (When Applicable)|Histopathological call based on ROSE of the ENB-aided tissue sample (when applicable) captured in the electronic data capture database being utilized for the study. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not part of the study design.|day of procedure||||Participants|||Count of Participants
2527134|NCT03588572|Secondary|A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT)|This test mainly assesses spontaneous speech fluency of participants.It requires participants name as many food names as possible within one minute, and each correct one to give one point.The higher the score, the better the language function.|This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.||||score on a scale||Standard Deviation|Mean
2527135|NCT03588572|Primary|A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB)|The main outcome measure for this scale is Aphasia Quotient(AQ) which mainly tests the ability of spontaneous speech, oral comprehension, repetition, and naming, and reflects the severity of aphasia, and can be used as a reliable indicator to evaluate the improvement and deterioration of aphasia. Score fluctuation is 0-100 points, the normal value is 98.4-100 points, AQ<93.8 can be judged as language dysfunction.|This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.||||score on a scale||Standard Deviation|Mean
2527136|NCT03587428|Secondary|Change From Baseline in Live:Dead Bacteria Ratio in Saliva Using Staining Technique|Anaerobic bacteria were counted using live:dead staining technique. Change from baseline was calculated for the ratio of live to dead bacteria.|At Baseline, 30 minutes, 1 hour and 2 hours post-treatment|The efficacy analysis was performed on ITT population.|||Ratio (unitless)||Standard Deviation|Mean
2527137|NCT03587428|Secondary|Change From Baseline in log10-transformed Total Viable Bacterial Count Using Traditional Bacterial Plating Technique|Anaerobic bacteria were counted using traditional plating technique. Total viable bacterial counts for each time-point was calculated individually for each participant for each treatment. Change from baseline in log 10 transformed total viable bacterial values was calculated.|At Baseline, 5 minutes, 15 minutes, 30 minutes, 1 hour and 2 hours post-treatment|The efficacy analysis was performed on ITT population.|||Log10 (cells/ml)||Standard Deviation|Mean
2527138|NCT03587428|Secondary|Change From Baseline in AUC (0-2) Hours for the Ratio of Live:Dead Bacteria Using Live-dead Staining Technique|Anaerobic bacteria were counted using live:dead staining technique. Change from baseline in AUC (0-2)hr was calculated for the ratio of live and dead bacteria. Viable bacterial counts for each time-point were calculated individually for each participant for each treatment and were aggregated into an AUC measurement. AUC was calculated using the trapezoidal rule and using nominal time points. The resulted values were then divided by 2hr to take out time units. The AUC was calculated over the range from pre-treatment time point (0hr) to 2hr. In this outcome measure, the change from baseline is calculated in log ratio of live: dead.|Baseline up to 2 hours|The efficacy analysis was performed on ITT population.|||Ratio (unitless)||Standard Deviation|Mean
2527139|NCT03587428|Primary|Change From Baseline in Area Under the Curve Between 0 and 2 Hours (AUC [0-2] Hours) for Total Viable Counts (TVCs) of Bacteria in Saliva Using Traditional Plating Technique|Area Under the Curve (AUC) between 0 and 2 hours (hr) was assessed using traditional plating technique which provides the total viable counts (TVCs) of anaerobic bacteria. This outcome measure is AUC of change from baseline in log TVC. AUC for each time-point were calculated individually for each participant for each treatment and were aggregated into an AUC measurement. The aggregated AUC measurement was calculated in the order that first the collected data is logged which is further analyzed by change in log. Then, AUC 0-2hr change in log was calculated using the trapezoidal rule. The resulted values were then divided by 2hr to take out time units and are logged to calculate bacteria count. Hence, the outcome measure calculates change from baseline in log10-transformed AUC 0-2hr over the range from pre-treatment time point (0hr) to the concentration at 120 minutes (min) i.e., 2hr.|Change from baseline in log10-transformed AUC 0-2hr|The efficacy analysis was performed on Intent to Treat (ITT) population.|||Log10 (cells/ml)||Standard Deviation|Mean
2527140|NCT03587207|Secondary|Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs (MAEs), AEs Leading to Withdrawal, and Adverse Events of Special Interest (AESIs)|SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability or incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Medically attended AEs are defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. AESIs are predefined (serious or non-serious) adverse events of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.|During the whole study period i.e from Day 1 to Day 91|Analysis was performed on the unsolicited safety set that included all subjects who provided informed consent, underwent screening procedures, had a subject number assigned, received any study vaccination and was reported with any adverse event data.|||Participants|||Count of Participants
2527141|NCT03587207|Secondary|Number of Subjects With Unsolicited AEs|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. An unsolicited AE is an AE that was not solicited using a Subject Diary and that was spontaneously communicated by a subjects/parent(s)/ Legally Acceptable Representative who has signed the informed consent or a solicited local or systemic adverse event that continues beyond the solicited period at day 7 after vaccination.|During the 30 days (including the day of vaccination) after each vaccination i.e after Dose 1 administered at Day 1 (for all groups) and after Dose 2 administered at Day 61 (for all groups except for MenACWY Group)|Analysis was performed on unsolicited safety set that included all subjects who provided informed consent,underwent screening procedures,had a subject number assigned,received any study vaccination & was reported with any unsolicited AE data.No results for dose 2 category for subjects of MenACWY Group as they received only 1 dose at day 1.|||Participants|||Count of Participants
2527286|NCT03577275|Secondary|Change From Baseline in PR Interval (PR)|Electrocardiogram measurement of change from baseline in PR interval (PR)|24 hours|maximum change from baseline during the study period is reported|||msec||Standard Error|Least Squares Mean
2527142|NCT03587207|Secondary|Number of Subjects With Any Solicited Systemic AEs|Assessed systemic AEs were arthralgia, fatigue, nausea, headache, myalgia and fever. Any fever is defined as body temperature equal or greater than 38 degrees Celsius.|During the 7 days (including the day of vaccination) after each vaccination i.e after Dose 1 administered at Day 1 (for all groups) and after Dose 2 administered at Day 61 (for all groups except for MenACWY Group)|Analysis was performed on solicited safety set that included all subjects who provided informed consent,underwent screening procedures,had a subject number assigned,received a study vaccination & was reported with any solicited adverse event data.No results for dose 2 category for subjects of MenACWY Group as they received only 1 dose at day 1.|||Participants|||Count of Participants
2527143|NCT03587207|Secondary|Number of Subjects With Any Solicited Local Adverse Events (AEs)|Assessed local AEs were erythema, swelling, induration and pain. Any erythema, swelling and induration is defined as a symptom with a surface diameter equal to or greater than 25 millimeters.|During the 7 days (including the day of vaccination) after each vaccination i.e after Dose 1 administered at Day 1 (for all groups) and after Dose 2 administered at Day 61 (for all groups except for MenACWY Group)|Analysis was performed on solicited safety set that included all subjects who provided informed consent,underwent screening procedures,had a subject number assigned,received a study vaccination & was reported with any solicited adverse event data.No results for dose 2 categories for subjects of MenACWY Group as they received only 1 dose at day 1.|||Participants|||Count of Participants
2527144|NCT03587207|Secondary|hSBA Adjusted GMRs Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination|hSBA mean ratios at 1 month after the first vaccination versus baseline were calculated in terms of GMRs. i.e. as the anti-logarithm of the mean of the change from baseline of log-transformed titer values at 1 month after first vaccination and Baseline. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted mean were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.|1 month after first vaccination versus baseline (i.e.: at Day 31 versus Day 1 for all groups except for the MenACWY Group)|Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup/B strain after first vaccination for all study groups except for MenACWY Group for which results were included in the last vaccination analysis (see primary outcome measure 5).|||Ratio||80% Confidence Interval|Geometric Mean
2527145|NCT03587207|Secondary|Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135, and Y, One Month After First Vaccination|Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with a 4-fold increase in hSBA titers. A 4-fold rise is defined as: a) for individuals whose pre-vaccination titers were less than (<) the limit of detection (LOD), the post-vaccination titers must have been ≥4-fold the LOD or ≥ the LLOQ, whichever was greater; b) for individuals whose pre-vaccination titers were ≥ the LOD and less than (<) the LLOQ, the post-vaccination titers must have been at least 4 times the LLOQ; and c) for individuals whose pre-vaccination titers were ≥ the LLOQ, the post-vaccination titers must have been at least 4 times the pre-vaccination titer. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).|1 month after first vaccination versus baseline (i.e.: at Day 31 versus Day 1 for all groups except for the MenACWY Group)|Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup/B strain after first vaccination for all study groups except for MenACWY Group for which results were included in the last vaccination analysis (see primary outcome measure 4).|||Percentage of subjects||80% Confidence Interval|Number
2527146|NCT03587207|Secondary|Percentage of Subjects With hSBA Titers Greater Than or Equal to (≥) the LLOQ Against Each of the N. Meningitidis Serogroup B Test Strains and Against Serogroups A, C, W-135, and Y, One Month After First Vaccination|Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with hSBA titers ≥ LLOQ. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).|1 month after first vaccination i.e.: at Day 31 for all groups except for the MenACWY Group|Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup/B strain after first vaccination for all study groups except for MenACWY Group for which results were included in the last vaccination analysis (see primary outcome measure 3).|||Percentage of subjects||80% Confidence Interval|Number
2527147|NCT03587207|Secondary|hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135 and Y, One Month After First Vaccination.|hSBA titers against each of the N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y were calculated in terms of GMTs. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted means were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.|1 month after first vaccination i.e.: at Day 31 for all groups except for the MenACWY Group.|Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup/ B strain after first vaccination for all study groups except for MenACWY Group for which results were included in the last vaccination analysis (see primary outcome measure 2).|||Titers||80% Confidence Interval|Geometric Mean
2527197|NCT03585543|Secondary|Number of Participants With Improved Fatigue Rating|Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Pediatric Short Form 10a: Raw Scores range from 0 - 40 with 0 being the least amount of fatigue and 40 the most fatigue. Change in score at 6 weeks minus baseline, 12 weeks minus baseline, and 12 weeks minus 6 weeks. Any decrease in rating = improved|baseline, 6 weeks, 12 weeks, 3 months post-intervention||2020-06-30|06/2020||||
2527148|NCT03587207|Secondary|hSBA Adjusted GMTs Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After First Vaccination|hSBA titers against all of N. meningitidis serogroup B test strains were calculated in terms of GMTs. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). The serogroup B strains were grouped together to perform a pooled analysis. Adjusted means were obtained from ANCOVA model fitted to all of the Serogroup B test strains, study group, test strain and center as fixed effects; zero-centered pre-vaccination log-transformed titer was included as a continuous covariate.|1 month after first vaccination i.e.: at Day 31 for all groups except for the MenACWY Group|Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup or B strain after first vaccination for all study groups except for MenACWY group that was not considered for this analysis as only serogroup B strains assessed in this outcome.|||Titers||80% Confidence Interval|Geometric Mean
2527149|NCT03587207|Primary|hSBA Adjusted Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.|hSBA mean ratios at 1 month after the last vaccination versus baseline were calculated in terms of GMRs i.e. as the anti-logarithm of the mean of the change from baseline of log-transformed titer values at 1 month after last vaccination and Baseline. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted means were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.|1 month after last vaccination versus baseline (i.e.: at Day 91 versus Day 1 for all groups except the MenACWY Group, and at Day 31 versus Day 1 for the MenACWY Group).|Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup or B strain at Day 91 for all study groups except MenACWY Group or at Day 31 for the MenACWY Group and at baseline for all study groups.|||Ratio||80% Confidence Interval|Geometric Mean
2527150|NCT03587207|Primary|Percentage of Subjects With a 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup B Test Strains and Against N. Meningitidis Serogroups A, C, W-135 and Y, One Month After Last Vaccination.|Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with a 4-fold increase in hSBA titers. A 4-fold rise was defined as: a) for individuals whose pre-vaccination titers were less than (<) the limit of detection (LOD), the post-vaccination titers must have been ≥4-fold the LOD or ≥ the LLOQ, whichever was greater; b) for individuals whose pre-vaccination titers were ≥ the LOD and less than (<) the LLOQ, the post-vaccination titers must have been at least 4 times the LLOQ; and c) for individuals whose pre-vaccination titers were ≥ the LLOQ, the post-vaccination titers must have been at least 4 times the pre-vaccination titer. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).|1 month after last vaccination versus baseline (i.e.: at Day 91 versus Day 1 for all groups except the MenACWY Group, and at Day 31 versus Day 1 for the MenACWY Group).|Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup or B strain at Day 91 for all study groups except MenACWY Group or at Day 31 for the MenACWY Group and at baseline for all study groups.|||Percentage of subjects||80% Confidence Interval|Number
2527151|NCT03587207|Primary|Percentage of Subjects With hSBA Titers Greater Than or Equal to(≥) the Lower Limit of Quantitation (LLOQ) Against Each of the N. Meningitidis Serogroup B Test Strains and Serogroups A, C, W-135 and Y,One Month After Last Vaccination.|Immune responses against N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y, were calculated in terms of percentage of subjects with hSBA titers ≥ LLOQ. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA).|1 month after last vaccination i.e.: at Day 91 for all groups except the MenACWY Group, and at Day 31 for the MenACWY Group.|Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup or B strain at Day 91 for all study groups except MenACWY Group or at Day 31 for the MenACWY Group.|||Percentage of subjects||80% Confidence Interval|Number
2527152|NCT03587207|Primary|hSBA Adjusted GMTs Against Each of the N. Meningitidis Serogroup B Test Strains and N. Meningitidis Serogroups A, C, W-135, and Y, One Month After Last Vaccination.|hSBA titers against each of the N. meningitidis serogroup B test strains and N. meningitidis serogroups A, C, W-135, and Y were calculated in terms of GMTs. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). Adjusted means were obtained from ANCOVA model fitted to each Serogroup (Strain) individually, study group and center as fixed effects and zero-centered pre-vaccination log-transformed titer as a continuous covariate.|1 month after last vaccination i.e.: at Day 91 for all groups except the MenACWY Group, and at Day 31 for the MenACWY Group.|Analysis was performed on PPS for immunogenicity that included subjects who had no major protocol violations and whose assay results were available for at least 1 serogroup or B strain at Day 91 for all study groups except MenACWY Group or at Day 31 for the MenACWY Group.|||titers||80% Confidence Interval|Geometric Mean
2527164|NCT03586726|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) for Balovaptan|Tmax is the first observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units.|Day 10 of Period 1 and Day 16 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Hour||Full Range|Median
2527165|NCT03586726|Secondary|Percentage of Participants With Adverse Events||Up to 21 days postdose|The safety analysis population consisted of subjects who received at least one dose of balovaptan.|||Percentage|||Number
2528722|NCT03491553|Secondary|Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12||Baseline, Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2527153|NCT03587207|Primary|Human Serum Bactericidal Activity (hSBA) Adjusted Geometric Mean Titers (GMTs) Against All of N. Meningitidis Serogroup B Test Strains (Pooled), One Month After Last Vaccination.|hSBA titers against all of N. meningitidis serogroup B test strains were calculated in terms of GMTs. Serogroup B strains tested were M14459 (factor H binding protein; fHbp), 96217 (Neisserial adhesin A; NadA), NZ98/254 (PorA), and M070241084 (Neisseria heparin binding antigen; NHBA). The serogroup B strains were grouped together to perform a pooled analysis. Adjusted means were obtained from ANCOVA model fitted to all of the Serogroup B test strains, study group, test strain and center as fixed effects; zero-centered pre-vaccination log-transformed titer was included as a continuous covariate.|1 month after last vaccination i.e.: at Day 91 for all groups except for the MenACWY Group|Analysis performed on Per Protocol Set(PPS) for immunogenicity that included subjects without major protocol violations & whose assay results were available for atleast 1 serogroup/B strain at Day 91 for all study groups except MenACWY group that was not considered for this analysis as only serogroup B strains were assessed in this outcome measure|||titers||80% Confidence Interval|Geometric Mean
2527154|NCT03586830|Secondary|Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Weight Loss at Week 12|Number of participants with >= 5 % weight loss at Week 12 was reported.|Week 12|mITT analysis set included all ITT participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement.|||Participants|||Count of Participants
2527155|NCT03586830|Secondary|Change From Baseline in Body Weight at Week 12|Change from baseline in body weight at Week 12 was reported.|Baseline, Week 12|mITT analysis set included all ITT participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||kg||Standard Error|Least Squares Mean
2527156|NCT03586830|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An TEAE is defined as an AE with an onset after the initiation study medication and before the last study medication date of the double-blind (12-Week) treatment phase plus 35 Days.|Up to 16 Weeks|Safety analysis set included include all randomized participants who had received at least one dose of study drug.|||Participants|||Count of Participants
2527157|NCT03586830|Primary|Percent Change From Baseline in Body Weight at Week 12|Percent change from baseline in body weight in kilograms (kg) at Week 12 was reported.|Baseline, Week 12|Modified intent-to-treat (mITT) analysis set included all intent-to-treat (ITT) participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Percent Change||Standard Error|Least Squares Mean
2527158|NCT03586726|Secondary|Metabolite to Parent Ratio for M3 Metabolite Based on Cmax||Day 10 of Period 1 and Day 16 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2527159|NCT03586726|Secondary|Metabolite to Parent Ratio for M3 Metabolite Based on AUC0-24||Day 10 and 11 of Period 1; Day 16 and 17 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2527160|NCT03586726|Secondary|Metabolite to Parent Ratio for M2 Metabolite Based on Cmax||Day 10 of Period 1 and Day 16 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2527161|NCT03586726|Secondary|Metabolite to Parent Ratio for M2 Metabolite Based on AUC0-24||Day 10 and 11 of Period 1; Day 16 and 17 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2527162|NCT03586726|Secondary|Time to Maximum Observed Plasma Concentration for M3 Metabolite|Tmax is the first observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units.|Day 10 of Period 1 and Day 16 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Hour(s)||Full Range|Median
2527163|NCT03586726|Secondary|Time to Maximum Observed Plasma Concentration for M2 Metabolite|Tmax is the first observed time to reach peak analyte concentration obtained directly from the experimental data without interpolation, expressed in time units.|Day 10 of Period 1 and Day 16 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Hours||Full Range|Median
2527179|NCT03585959|Secondary|Final Pathology Results of the ENB-aided Tissue Sample|Final pathology results of the ENB-aided tissue sample captured in the electronic data capture database being utilized for the study. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not part of the study design.|Based on final pathology results of the ENB-aided biopsy sample collected day of procedure||||Participants|||Count of Participants
2527166|NCT03586726|Primary|Area Under the Plasma Concentration Curve From Time 0 to 24 Hours for M3 Metabolite|AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post dose.|Day 10 and 11 of Period 1; Day 16 and 17 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2527167|NCT03586726|Primary|Area Under the Plasma Concentration Curve From Time 0 to 24 Hours for M2 Metabolite|AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post dose.|Day 10 and 11 of Period 1; Day 16 and 17 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2527168|NCT03586726|Primary|Area Under the Plasma Concentration Curve From Time 0 to 24 Hours (AUC0-24) for Balovaptan|AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post dose.|Day 10 and 11 of Period 1; Day 16 and 17 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2527169|NCT03586726|Primary|Maximum Plasma Concentration (Cmax) for M3 Metabolite|Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.|Day 10 of Period 1 and Day 16 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2527170|NCT03586726|Primary|Maximum Plasma Concentration (Cmax) for M2 Metabolite|Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.|Day 10 of Period 1 and Day 16 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2527171|NCT03586726|Primary|Maximum Plasma Concentration (Cmax) for Balovaptan|Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.|Day 10 of Period 1 and Day 16 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least one dose of balovaptan. Participants were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2527172|NCT03585959|Secondary|Relational Accuracy in Cases in Which the Intended Lesion is Targeted|In Technically successful cases (local registration complete) with evaluable videos the relational accuracy in cases in which the intended lesion is targeted was assessed. Relational accuracy is defined as the three-dimensional percentage overlap between the virtual target and the actual lesion in CBCT before (FNAV/CBCT 1) and after (FNAV/CBCT 2) correction of the catheter location.|day of procedure|47 cases were technically successful. From 47 cases, 4 couldn't be analyzed due to inadequate video recording. From 43 cases, 2 cases only had data from FNAV/CBCT 1 (Before Correction of Catheter Location) and 2 cases only had data from FNAV/CBCT 2 (After Correction of Catheter Location) resulting in 41 evaluable subjects per FNAV/CBCT group.|||3D percent overlap||Full Range|Median
2527173|NCT03585959|Secondary|Percentage of Cases in Which the Intended Lesion is Correctly Identified|In technically successful cases (local registration complete) the percentage of cases in which the intended lesion is correctly identified (as opposed to a non-target lesion or normal lung tissue) as indicated by the system software.|day of procedure|38 subjects had adequate video files to assess this endpoint|||Participants|||Count of Participants
2527174|NCT03585959|Secondary|Diagnosis for Each Tool Based on Pathology of the ENB-aided Sample|"The tool-specific accuracy for malignancy is calculated out of only the malignant cases using that tool. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not a part of the study design."|Based on final pathology results of the ENB-aided sample collected day of procedure|Patients with overall malignant results by Pathology (30/49 cases). The number analyzed varies by tool based on the number of cases which used each tool. More than one tool could be used per case.|||malignant results|||Number
2527175|NCT03585959|Secondary|Diagnoses for Each Tool Based on ROSE of the ENB-aided Sample|"The tool-specific accuracy for malignancy is calculated out of only the malignant cases using that tool. Only malignant results are presented, as adequate follow-up to confirm the benign/inconclusive results was not a part of the study design."|Based on ROSE results of the ENB-aided biopsy sample collected day of procedure|Patients with overall malignant results by ROSE (26/49 cases). The number analyzed varies by tool based on the number of cases which used each tool. More than one tool could be used per case. Bronchoalveolar Lavage is not applicable for ROSE.|||participants|||Number
2527176|NCT03585959|Secondary|Number of Tool Pases|An analysis of the number of passes for each tool was planned, but it was determined that it wouldn't be clinically meaningful to go into that level of detail for the analysis and instead focused on the number of passes for only the first tool used.|day of procedure||||passes||Standard Deviation|Mean
2527177|NCT03585959|Secondary|Tool Order|Tool order analysis reports the number of times that a tool was used first in a patient.|day of procedure||||Participants|||Count of Participants
2527178|NCT03585959|Secondary|Biopsy Tools Used|Biopsy tools used was captured in the electronic data capture database being utilized for the study on all subjects with local registration attempted. If subject use same tool more than once, only counts once.|day of procedure||||tool use|||Number
2527181|NCT03585959|Secondary|Adequacy of the ENB-aided Tissue Sample|"Adequacy of the ENB-aided tissue sample for rapid on-site evaluation (ROSE) of cytologic samples by pathology (when applicable). This will be captured in the electronic data capture database.ROSE results could be reported as Benign, Inconclusive, Malignant, Inadequate Tissue for ROSE, or N/A. If all ROSE diagnoses were report as Inadequate Tissue for ROSE, for a participant, then the case was considered as Inadequate Tissue."|Based on final pathology results of the ENB-aided biopsy sample collected day of procedure|ROSE was attempted in 49/49 cases.|||Participants|||Count of Participants
2527182|NCT03585959|Secondary|Total Fluoroscopy Time|Total fluoroscopy time captured in the electronic data capture database being utilized for the study was determined to not be clinically relevant. Instead, the fluoroscopic navigation time is presented. Fluoroscopic Navigation Time: Two sweeps pooled. Encompasses c-arm sweep, target marking, and algorithm computational time, inclusive of the initiation of the local registration applet to the time the updated catheter location was ready and on screen (not including CBCT), as measured by the system software|day of procedure|Four cases were considered technically successful but could not be analyzed due to inadequate video recording and an additional four technically successful cases had data from only FNAV/CBCT 1 (n=2) or only FNAV/CBCT 2 (n=2), resulting in evaluable datasets of 41 subjects per FNAV/CBCT group.|||Minutes|Local Registrations|Full Range|Median
2527183|NCT03585959|Secondary|ENB Procedure Time|ENB procedure time captured in the electronic data capture database being utilized for the study defined as the total time from the first entry of the extended working channel or locatable guide until the last exit of the extended working channel. This includes all study-specific fluoroscopy and CBCT steps which would not normally occur in standard practice|day of procedure||||Minutes||Standard Deviation|Mean
2527184|NCT03585959|Secondary|Total Procedure Time|Total time from the first entry of the bronchoscope to the final removal of the bronchoscope. This includes all study-specific fluoroscopy and CBCT steps which would not normally occur in standard practice|day of procedure||||minutes||Standard Deviation|Mean
2527185|NCT03585959|Secondary|"Investigator Confirmation That the Catheter is in an Adequate Periprocedural Location Using the Electromagnetic Navigation Bronchoscopy (ENB) Technology."|"Investigator confirmation that the catheter was in an adequate periprocedural location (the location of the extended working channel when the proceduralist made the decision that placement was adequate and clinically acceptable to proceed with tissue sampling). Adequate periprocedural location is reported with use of local registration."|day of procedure||||Participants|||Count of Participants
2527186|NCT03585959|Secondary|Number of Cases That Are Not Technically Successful (Local Registration Not Complete)|By device design, if the local registration algorithm determines that the correction distance is greater than 3.0 cm the location of the virtual target will not be updated. These cases are not considered technically successful according to the clinical study definitions, even though the device performed as designed.|day of procedure|2 of 49 cases did not complete local registration|||Participants|||Count of Participants
2527187|NCT03585959|Secondary|Number of Cases That Are Technically Successful (Successful Completion of Local Registration)|Technical success was defined as successful completion of local registration utilizing fluoroscopic navigation technology.|day of procedure||||Participants|||Count of Participants
2527188|NCT03585959|Primary|Confirm the Location Accuracy of the Local Registration Feature|"The Primary Endpoint is the measured ability of the superDimension™ Navigation System v7.2 with Fluoroscopic Navigation Technology to place the center of the virtual navigation target (green ball) on the intended target lesion as confirmed by cone-beam computed tomography (CBCT).~The primary endpoint was evaluated in technically successful cases (those with local registration complete) and calculated as the percentage of cases in which the virtual target was correctly placed to overlap the target lesion, as confirmed by CBCT. The percent overlap was calculated in three dimensions (X, Y, and Z coordinates). Any case with more than 0% overlap was considered a primary endpoint success."|day of procedure|47 cases were technically successful. From 47 cases, 4 couldn't be analyzed due to inadequate video recording. From 43 cases, 2 cases only had data from FNAV/CBCT 1 (Before Correction of Catheter Location) and 2 cases only had data from FNAV/CBCT 2 (After Correction of Catheter Location) resulting in 41 evaluable subjects per FNAV/CBCT group.|||Participants|||Count of Participants
2527189|NCT03585790|Primary|Subject Reported Eye Fatigue|"Subjective Rating of Eye Fatigue, response to question How would you rate your overall eye fatigue/tiredness? on a 0-100 slider visual analog scale, where 0 represents 'Not Noticeable' and 100 represents 'Very Noticeable', with the numerical representation of their visual analog selection displayed to the right of the slider scale. Score reported is rating as described above."|1 week|Outcome measures reported for both groups combined secondary to crossover design.|||units on a scale||Inter-Quartile Range|Median
2527190|NCT03585543|Secondary|Symptom Monitoring and Tracking|types of recorded treatments for symptoms|12 weeks||2020-06-30|06/2020||||
2527191|NCT03585543|Secondary|Symptom Monitoring and Tracking|number of days with recorded treatments for symptoms|12 weeks||2020-06-30|06/2020||||
2527192|NCT03585543|Secondary|Home Medication Administration|number of days daily medication administered, number of days PRN medications administered|12 weeks||2020-06-30|06/2020||||
2527193|NCT03585543|Secondary|Clinic Appointment Attendance|number of scheduled clinic appointments attended|12 weeks||2020-06-30|06/2020||||
2527194|NCT03585543|Secondary|Symptom Monitoring and Tracking|number of days with recorded symptoms|12 weeks||2020-06-30|06/2020||||
2527195|NCT03585543|Secondary|Number of Participants With Improved Depressive Symptoms Rating|Patient Reported Outcomes Measurement System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Change in score at 6 weeks minus baseline, 12 weeks minus baseline, and 12 weeks minus 6 weeks. Any decrease in rating = improved|baseline, 6 weeks, 12 weeks, 3 months post-intervention||2020-06-30|06/2020||||
2527196|NCT03585543|Secondary|Number of Participants With Improved Anxiety Rating|Patient Reported Outcomes Measurement System (PROMIS) Pediatric Short Form Anxiety 8a: Raw Scores range from 0 - 32, with 0 being the lowest anxiety rating and 32 the highest anxiety rating. Change in score at 6 weeks minus baseline, 12 weeks minus baseline, and 12 weeks minus 6 weeks. Any decrease in rating = improved|baseline, 6 weeks, 12 weeks, 3 months post-intervention||2020-06-30|06/2020||||
2527390|NCT03570658|Secondary|Maximum Observed Plasma Concentration (Cmax) of RO7049389||At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)|PK sampling was performed only once for single-dose (SAD) cohorts and did not include the placebo arms.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2527198|NCT03585543|Secondary|Number of Participants With Improved Quality of Life Rating|Pediatric Quality of Life Inventory (Peds QL) with SCD module: Scores are transformed on a scale from 0 - 100, with 0 indicating the highest possible problems with quality of life and 100 indicating the lowest possible problems with quality of life. Change in score at 6 weeks minus baseline, 12 weeks minus baseline, and 12 weeks minus 6 weeks. Any increase in rating = improved|baseline, 6 weeks, 12 weeks, 3 months post-intervention||2020-06-30|06/2020||||
2527199|NCT03585543|Secondary|Number of Participants (Caregivers) With Improved Self-efficacy Rating|"Patient Reported Outcomes Measurement Information System (PROMIS) Self-efficacy for managing chronic conditions:~Subscales: Self-efficacy for managing emotions 4a, Self-efficacy for managing symptoms 4a, Self-efficacy for managing daily activities 4a, Self-efficacy for managing social interactions 4a, Self-efficacy for managing medications and treatments 4a: Raw Scores for each subscale range from 4 - 20, with 4 being the lowest level of self-efficacy and 20 the highest level of self-efficacy. Change in score at 6 weeks minus baseline, 12 weeks minus baseline, and 12 weeks minus 6 weeks. Any increase in rating = improved"|baseline, 6 weeks, 12 weeks, 3 months post-intervention||2020-06-30|06/2020||||
2527200|NCT03585543|Secondary|Number of Participants With Improved Pain Ratings|Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference Pediatric Short Form 8a: Change in score at 6 weeks minus baseline, 12 weeks minus baseline, and 12 weeks minus 6 weeks. Raw scores range from 0 - 32, with 0 being the lowest pain rating and 32 the highest pain rating. Any decrease in rating = improved|baseline, 6 weeks, 12 weeks, 3 months post-intervention||2020-06-30|06/2020||||
2527201|NCT03585543|Primary|Participant Adherence to Intervention|number of participants who sent messages to nurse practitioner|baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months||||participants|||Number
2527202|NCT03585543|Primary|Participant Adherence to Intervention|Number of participants who accessed the symptom monitoring component of the intervention, assessed using the app back end database|baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months||||participants|||Number
2527203|NCT03585543|Primary|Participant Adherence to Intervention|number of participants who accessed the educational component of intervention, assessed using back end app use database|baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months||||participants|||Number
2527204|NCT03585543|Primary|Acceptability of Intervention|Number of participants reporting problems with the intervention (mHealth app) per week.|Assessed each week over a period of 6 months, cumulative data up to 6 months is reported.||||Participants|||Count of Participants
2527205|NCT03585543|Primary|Participant Adherence to Intervention|Number of participants who used the intervention (mHealth application) from baseline to mid-intervention, from mid-intervention to end-of-intervention, and from end-of-intervention to follow-up, assessed by number of participants who logged into and used the app, stored in the app's back end database.|baseline to 6 weeks, 6 weeks to 12 weeks, 12 weeks to 6 months||||participants|||Number
2527206|NCT03585543|Primary|Rates of Recruitment|Number of weeks required to recruit 30 participants.|Assessed each week over a period of 6 months, cumulative data up to 6 months is reported.||||weeks|||Number
2527207|NCT03585504|Secondary|Number of Participants Who Reported That They Were Somewhat or Very Satisfied With the Contraceptive Implant at Six Months Postpartum.|"Comparison of the number of participants in each group who report that they were somewhat or very satisfied with their contraceptive method choice at six months postpartum in each group. Participants were asked,  How would you rate your overall satisfaction with implanon? The response options were very satisfied, somewhat satisfied, somewhat dissatisfied, and very dissatisfied. The outcome measure was treated as a categorical variable."|6 months||||Participants|||Count of Participants
2527208|NCT03585504|Secondary|Number of Participants That Reported They Were Somewhat or Very Satisfied With Their Subjective Bleeding Experience at Six Months Postpartum.|"Compare the number of participants who reported that they were somewhat or very satisfied with their subjective bleeding experience at six months postpartum in each group. Each participant was asked, Please indicate your overall level of satisfaction with your bleeding. The response options were very satisfied, somewhat satisfied, somewhat dissatisfied, and very dissatisfied. The outcome measure was treated as a categorical variable."|6 months||||Participants|||Count of Participants
2527209|NCT03585504|Primary|Number of Participants With Contraceptive Implant Continuation at Six Months Postpartum|We compare the number of participants continuing the implant at six months in each group.|6 months||||Participants|||Count of Participants
2527210|NCT03585296|Primary|Number of Subjects withTreatment-Emergent Adverse Events (Safety and Tolerability)|Treatment emergent adverse events (TEAEs)graded on a 3 point scale of mild, moderate or severe|8 weeks||||Participants|||Count of Participants
2527211|NCT03583385|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. Number of participants with TEAEs included participants with both non serious and serious TEAEs.|Up to Day 51|The safety analysis set included all participants who have received at least one dose of the investigational product and have had one subsequent safety assessment.|||Participants|||Count of Participants
2527212|NCT03583385|Secondary|Terminal Elimination Half-life in Plasma (t½) of Metformin|Elimination Half Life (t1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half.|Pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24, and 32 hours post-dose on Day 1|PK analysis set included all participants without any relevant protocol deviations with respect to PK and absence of factors likely to affect the comparability of PK results, with adequate study medication compliance, and who have valid primary endpoints for both treatment.|||Hours||Standard Deviation|Mean
2527976|NCT03535844|Secondary|Change in Blood Lipid-lipoprotein Concentrations|Total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and total triglyceride|Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported||||mmol/L||Standard Deviation|Mean
2527213|NCT03583385|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Metformin|Time of the maximum drug concentration.|Pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24, and 32 hours post-dose on Day 1|PK analysis set included all participants without any relevant protocol deviations with respect to PK and absence of factors likely to affect the comparability of PK results, with adequate study medication compliance, and who have valid primary endpoints for both treatment.|||Hours||Full Range|Median
2527214|NCT03583385|Secondary|Area Under Plasma Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Metformin|AUC (0-inf) is defined as the area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0-inf).|Pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24, and 32 hours post-dose on Day 1|PK analysis set included all participants without any relevant protocol deviations with respect to PK and absence of factors likely to affect the comparability of PK results, with adequate study medication compliance, and who have valid primary endpoints for both treatment.|||ng*h/mL||Standard Deviation|Mean
2527215|NCT03583385|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Metformin|Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration.|Pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24, and 32 hours post-dose on Day 1|PK analysis set included all participants without any relevant protocol deviations with respect to PK and absence of factors likely to affect the comparability of PK results, with adequate study medication compliance, and who have valid primary endpoints for both treatment.|||Nanogram*hour per milliliter (ng*h/mL)||Standard Deviation|Mean
2527216|NCT03583385|Primary|Maximum Observed Plasma Concentration (Cmax) of Metformin|The maximum plasma concentration of Metformin.|Pre-dose, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24, and 32 hours post-dose on Day 1|Pharmacokinetic (PK) analysis set included all participants without any relevant protocol deviations with respect to PK and absence of factors likely to affect the comparability of PK results, with adequate study medication compliance, and who have valid primary endpoints for both treatment.|||Nano-gram per milliliter (ng/mL)||Standard Deviation|Mean
2527217|NCT03582943|Primary|Change in Balance Score|Balance score at the end of training - balance score at baseline, where balance score is the average amount of time in seconds that a participant maintains the stability platform within ±3° of horizontal position during 5 trials of 30 seconds each. Five trials are averaged to form the balance score at each time point.|1 week|Only participants who completed the entire protocol and did not have a protocol deviation were analyzed.|||seconds||Standard Deviation|Mean
2527218|NCT03582813|Secondary|Change in Mental Health Service Cost|Mental health service cost is measured by the amount of reimbursement for a paid claim from the Texas Department of State Health Services Data Warehouse, It represents the amount of dollars paid for delivery of a discrete behavioral health service. Higher value = higher cost. Minimum = 1 and maximum = 5,493.|First 12 months of study participation; Second 12 months of study participation; total 24 months of study participation||||Dollar Amount||Standard Deviation|Mean
2527219|NCT03582813|Secondary|Number of Participants Enrolled in Classes|Change in education participation status as measured by U.S. Department of Education's definition of school enrollment: enrolled in classes requiring registration and fee payment versus not enrolled in classes. Higher value = enrolled in classes. Minimum = 0 and maximum = 1.|Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)|"The number reflected in the Overall Number of Participants Analyzed pertains to the number of participants who completed the baseline interview."|||Participants|||Count of Participants
2527220|NCT03582813|Secondary|Number of Participants With Employment|"Change in employment status as measured by Bureau of Labor Statistics definition of paid employment: with paid employment versus without paid employment. Higher value equals with paid employment.~Minimum = 0 and maximum = 1."|Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)|"The number reflected in the Overall Number of Participants Analyzed pertains to the number of participants who completed the baseline interview."|||Participants|||Count of Participants
2527221|NCT03582813|Secondary|Perceived Autonomy Support|Perceived support for autonomously motivated change measured by the Learning Climate Questionnaire of Williams & Deci. Measures change in perception that service environment is supportive of autonomy to make decisions and choices. Higher score equals better autonomy support. Minimum = 4 and maximum = 105.|Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)|"The number reflected in the Overall Number of Participants Analyzed pertains to the number of participants who completed the baseline interview."|||score on a scale||Standard Deviation|Mean
2527222|NCT03582813|Secondary|Coping Mastery|Change in subjects' sense of personal control over important life outcomes as measured by the Coping Mastery Scale. Higher values equal better coping mastery. Minimum = 2 and maximum = 49.|Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)|"The number reflected in the Overall Number of Participants Analyzed pertains to the number of participants who completed the baseline interview."|||score on a scale||Standard Deviation|Mean
2527223|NCT03582813|Secondary|Change in Self-esteem|Feelings of self-worth and confidence in general abilities as measured by the Rosenberg Self-Esteem Scale . Higher vales equal better self=esteem. Minimum = 10 and maximum = 40.|Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)|"The number reflected in the Overall Number of Participants Analyzed pertains to the number of participants who completed the baseline interview."|||score on a scale||Standard Deviation|Mean
2527224|NCT03582813|Primary|Recovery From Mental Illness|"This outcome is measured by the Recovery Assessment Scale (RAS). Recovery is a psychosocial outcome assessed via patient self-ratings on a 41-item scale using a 5-point Likert-Response format ranging from strongly disagree to strongly agree. The minimum value for the RAS is 41 and the maximum is 205, with higher scores indicating a better outcome. Dimensions of recovery include personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and not being dominated by one's residual psychiatric symptoms."|Study entry (pre-intervention), 12 months later (midpoint of intervention), & 24 months later (end of intervention)|"The number reflected in the Overall Number of Participants Analyzed pertains to the number of participants who completed the baseline interview."|||score on a scale||Standard Deviation|Mean
2527226|NCT03582553|Secondary|Measurement of Apparent Oral Clearance of Naringenin at 150 and 600 mg Doses|Blood will be drawn over a period of 24 hours following ingestion of the 150 and 600mg doses of naringenin and serum naringenin concentrations will be measured. The apparent oral clearance of naringenin will be determined.|0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours|Subjects who completed the study|||L/hour||Standard Error|Least Squares Mean
2527227|NCT03582553|Secondary|Measurement of Half Life of Naringenin at 150 and 600 mg Doses|Blood will be drawn over a period of 24 hours following ingestion of the 150 and 600mg doses of naringenin and serum naringenin concentrations will be measured. The half life of naringenin will be determined.|0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours|Subjects who completed the study. The half-life uses all the pooled data to calculate an estimate of the slope (k) to determine the half-life estimate. We did not calculate the slope of each individual subject.|||hour|||Number
2527228|NCT03582553|Secondary|Measurement of Time to Peak Concentration of Serum Naringenin at 150 and 600 mg Doses|Blood will be drawn over a period of 24 hours following ingestion of the 150 and 600mg doses of naringenin and serum naringenin concentrations will be measured. The time to peak serum naringenin concentration will be determined.|24 hours|Subjects who completed the study|||hour||Standard Error|Least Squares Mean
2527229|NCT03582553|Secondary|Measurement of Maximal Concentration of Serum Naringenin at 150 and 600 mg Doses|Blood will be drawn over a period of 24 hours following ingestion of the 150 and 600mg doses of naringenin and serum concentrations will be measured. The maximal serum concentration will be determined.|0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours||||ug/mL||Standard Error|Mean
2527230|NCT03582553|Secondary|Measurement of Area Under the Serum Naringenin Concentration Versus Time Curve at 150 and 600 mg Doses|Blood will be drawn over a period of 24 hours following ingestion of the 150 and 600mg doses of naringenin and serum concentrations will be measured. The area under the serum concentration versus time curve will be determined.|0, 2, 3, 3.5, 4, 4.5, 6, 8,12, and 24 hours|Subjects who completed the study|||(ug/mL) x hour||Standard Error|Least Squares Mean
2527231|NCT03582553|Primary|Incidence of Treatment-emergent Adverse Events Following a Single Dose of a Citrus Extract of Naringenin|All adverse events will be recorded following the first administration of the study product or placebo. The study physician in consultation with the coordinator will review and determine whether a subject can be administered the next ascending dose. The cohorts will be run in series. There will be an interval of up to four weeks between the two cohorts. During this time an interim analysis will be conducted and a safety summary of adverse events for Cohort 1 will be compiled and reviewed by the investigators. Dose safety will be investigated by compiling by treatment (e.g. 150 mg dose, 300 mg dose, placebo) a list of adverse events. The frequency of these events will be counted and compared with the placebo group.|Adverse events were collected over approximately five weeks which included three study days and two washout periods of at least one week.|Subjects who completed the study|||Participants|||Count of Participants
2527232|NCT03582215|Secondary|Octinoxate Maximum Concentration|Maximum concentration (observed peak drug concentration) (Cmax)|0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, 144, 216, 312, and 480 h for Part 2|All subjects who received at least one application and had at least one pharmacokinetic sample. For Part 1, octinoxate was not analyzed for cream, lotion, spray 1, and spray 2 and all products were excluded from the analysis. For Part 2, lotion and aerosol spray did not contain octinoxate and were excluded from the analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2527233|NCT03582215|Secondary|Octisalate Maximum Concentration|Maximum concentration (observed peak drug concentration) (Cmax)|0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, 144, 216, 312, and 480 h for Part 2|All subjects who received at least one application and had at least one pharmacokinetic sample. For Part 1, cream, lotion, and spray 2 and for Part 2, lotion did not contain octisalate and were excluded from the analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2527234|NCT03582215|Secondary|Homosalate Maximum Concentration|Maximum concentration (observed peak drug concentration) (Cmax)|0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, 144, 216, 312, and 480 h for Part 2|All subjects who received at least one application and had at least one pharmacokinetic sample. For Part 1, cream, lotion, and spray 2 and for Part 2, lotion did not contain homosalate and were excluded from the analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2527235|NCT03582215|Secondary|Ecamsule Maximum Concentration|Maximum concentration (observed peak drug concentration) (Cmax)|0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, and 144 h for Part 1|All subjects who received at least one application and had at least one pharmacokinetic sample. For Part 1, lotion, spray 1, and spray 2 and for Part 2, lotion, aerosol spray, nonaerosol spray, and pump spray did not contain ecamsule and were excluded from the analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2527236|NCT03582215|Secondary|Octocrylene Maximum Concentration|Maximum concentration (observed peak drug concentration) (Cmax)|0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, and 144 h for Part 1; same time points and 216, 312, and 480 h for Part 2|All subjects who received at least one application and had at least one pharmacokinetic sample. For Part 2, pump spray product did not contain octocrylene and was excluded from the analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2527237|NCT03582215|Secondary|Oxybenzone Maximum Concentration|Maximum concentration (observed peak drug concentration) (Cmax)|0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, and 144 h for Part 1; same time points and 216, 312, and 480 h for Part 2|All subjects who received at least one application and had at least one pharmacokinetic sample. For Part 1, cream and for Part 2, nonaerosol spray and pump spray products did not contain oxybenzone and were excluded from the analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2527238|NCT03582215|Primary|Avobenzone Maximum Concentration|Maximum concentration (observed peak drug concentration) (Cmax)|0, 0.5, 1, 1.5, 2, 4, 6, 8, 9, 10, 12, 14, 23, 28, 33, 47, 52, 57, 71, 73, 74, 76, 78, 81, 82, 84, 86, 95, 120, and 144 h for Part 1; same time points and 216, 312, and 480 h for Part 2|All subjects who received at least one application and had at least one pharmacokinetic sample|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2528886|NCT03476278|Secondary|Mood State According to Education|Patients' mood state according to their highest degree of education received|1 day||||Participants|||Count of Participants
2527239|NCT03581825|Secondary|CLUE Vision Comparison Between Test and Control|Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|2-Week Follow-up|All subjects who had successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.|||units on a scale||Standard Deviation|Mean
2527240|NCT03581825|Primary|CLUE Vision|Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|2-Week Follow-up|All subjects who had successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.|||units on a scale||Standard Deviation|Mean
2527241|NCT03581474|Primary|Improvement in Oxygenation (PaO2/FiO2 Ratio) After a BAL Treatment|Resolution of atelectasis measured by improvement in oxygenation after a bronchoscopic procedure (bronchoalveolar lavage treatment). PaO2/FiO2 ratio will be compared between baseline and 4 hourst post the BAL procedure.|4 hours after procedure|Missing data at 4h post measures for one subject|||PaO2/FiO2||Standard Deviation|Mean
2527242|NCT03581097|Secondary|Third Subgroup Analyze: First Experience With Surgery.|A subgroup analysis was performed applied to specific subgroups, like patients at their first experience with surgery, identified by specific questionnaire.|2 hours|A third subgroup analysis took into account patients for whom the operation was their first surgical experience.|||mmHg||Standard Deviation|Mean
2527243|NCT03581097|Secondary|Second Subgroups Analyze: Higher Anxiety Score|A subgroup analysis was performed applied to specific subgroups, like patients with higher anxiety assessment result, identified to have 3 or more on the 5 point on Visual Analog Scale - Adapted (VAS-A) score (ranging from 1 - no anxious - to 5 - totally anxious).|2 hours|This analysis is made to see if video is ineffective in reducing anxiety level|||mmHg||Standard Deviation|Mean
2527244|NCT03581097|Secondary|First Subgroups Analyze: Anxious Patients|A subgroup analysis was performed applied to specific subgroups, like anxious patients.|2 hours||||mmHg||Standard Deviation|Mean
2527245|NCT03581097|Secondary|Vital Parameters 3: Heart Rate|To see any variance in vital parameters that are usually affected by anxiety like heart rate [beat per minute] in all patients.|2 hours|Cardiac rate at anesthesia|||bpm||Standard Deviation|Mean
2527246|NCT03581097|Secondary|Vital Parameters 2: Respiratory Rate|To see any variance in vital parameters that are usually affected by anxiety like respiratory rate [breath per minute] in all patients.|2 hours|Respiratory rate at anesthesia|||breath per minute||Standard Deviation|Mean
2527247|NCT03581097|Secondary|Vital Parameters 1: Arterial Blood Pressure|To see any variance in vital parameters that are usually affected by anxiety, like arterial blood pressure [mmHg] in all patients.|2 hours|Systolic arterial pressure measured on admission in the day-hospital clinic.|||mmHg||Standard Deviation|Mean
2527248|NCT03581097|Secondary|Degree of Satisfaction|To perceive any disparity in patient's satisfaction degree measured through final questionnaire. A satisfaction questionnaire with evaluation from 0 (min) to 10 (max) regarding this topics. Higher values represent the better outcome, lower values represent the worse outcome.|3 hours|Control group underwent a surgical pre-operative examination, during which they received detailed information about surgical procedure but not regarding anesthetic technique. Video group patients received the same preoperative preparation procedur, and also watched a video group patients showed a 6-minute educational information video about IVRA.|||units on a scale (0-10)||Standard Deviation|Mean
2527249|NCT03581097|Primary|VAS-A Score Anxiety Level (Adapted Visual-Analogue Scale)|Primary outcome measure is to see and analyze any difference in preoperative anxiety between the video and control group, measured on our Adapted Visual Analogue Scale (VAS-A). Scale range is 0 to 5, where 0 means no anxiety, while 5 means maximal anxiety. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the operating room and the performance of regional anesthesia.|2 hours|Anxiety level measured on admission in the day-hospital clinic|||score on a scale||Standard Deviation|Mean
2527250|NCT03579940|Secondary|PK: Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period|PK: Cmax of Lasmiditan in Each Period was evaluated.|Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours postdose|All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2527251|NCT03579940|Secondary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period|PK: AUC(0-∞) of Lasmiditan in Each Period was evaluated.|Period 1 and Period 2: predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose; Period 3: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 12, 24, 36 and 48 hours postdose|All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2527252|NCT03579940|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.|Baseline up to Day 20|All enrolled participants who received at least one dose of study drug.|||Participants|||Count of Participants
2527977|NCT03535844|Primary|Change in Blood Carotenoid Status|Fasting state plasma carotenoids using high performance liquid chromatography.|Pre- and post-intervention (Week 16)||||nmol/L||Standard Deviation|Mean
2527253|NCT03579719|Primary|Time to Maximum Observed Plasma Concentration (Tmax) for M3 Metabolite||Day 10 of Period 1; Day 10 and Day 15 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least 1 dose of balovaptan. Subjects were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Hour(s)||Full Range|Median
2527254|NCT03579719|Primary|Time to Maximum Observed Plasma Concentration (Tmax) for M2 Metabolite (as Applicable)||Day 10 of Period 1; Day 10 and Day 15 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least 1 dose of balovaptan. Subjects were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Hour(s)||Full Range|Median
2527255|NCT03579719|Primary|Time to Maximum Observed Plasma Concentration (Tmax) for Balovaptan||Day 10 of Period 1; Day 10 and Day 15 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least 1 dose of balovaptan. Subjects were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Hour(s)||Full Range|Median
2527256|NCT03579719|Secondary|Percentage of Participants With Adverse Events||Up to 21 days postdose|The safety analysis population consisted of subjects who received at least one dose of balovaptan.|||Percentage|||Number
2527257|NCT03579719|Secondary|Time to Steady State for Balovaptan||Days 1, 3, 5, 8, 9, 10 in Period 1 and Days 1, 3, 5, 8, 9, 10, 13, 14, 15 in Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least 1 dose of balovaptan. Subjects were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||Day|||Number
2527258|NCT03579719|Secondary|Trough Plasma Concentration (Ctrough) for M3 Metabolite||Day 10 of Period 1; Day 10 and Day 15 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least 1 dose of balovaptan. Subjects were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng/mL||Standard Deviation|Mean
2527259|NCT03579719|Secondary|Trough Plasma Concentration (Ctrough) for M2 Metabolite (as Applicable)||Day 10 of Period 1; Day 10 and Day 15 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least 1 dose of balovaptan. Subjects were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng/mL||Standard Deviation|Mean
2527260|NCT03579719|Secondary|Trough Plasma Concentration (Ctrough) for Balovaptan||Day 10 of Period 1; Day 10 and Day 15 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least 1 dose of balovaptan. Subjects were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng/mL||Standard Deviation|Mean
2527261|NCT03579719|Primary|Area Under the Concentration Vs Time Curve Over the Dosing Interval (AUC0-tau) for M3 Metabolite||Day 10 of Period 1, Day 10 and Day 15 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least 1 dose of balovaptan. Subjects were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2527262|NCT03579719|Primary|Area Under the Concentration Vs Time Curve Over the Dosing Interval (AUC0-tau) for M2 Metabolite (as Applicable)||Day 10 of Period 1, Day 10 and Day 15 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least 1 dose of balovaptan. Subjects were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2527263|NCT03579719|Primary|Area Under the Concentration Vs Time Curve Over the Dosing Interval (AUC0-tau) for Balovaptan||Day 10 of Period 1, Day 10 and Day 15 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least 1 dose of balovaptan. Subjects were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2527264|NCT03579719|Primary|Maximum Plasma Concentration (Cmax) for M3 Metabolite|Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.|Day 10 of Period 1, Day 10 and Day 15 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least 1 dose of balovaptan. Subjects were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2527265|NCT03579719|Primary|Maximum Plasma Concentration (Cmax) for M2 Metabolite (as Applicable)|Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.|Day 10 of Period 1, Day 10 and Day 15 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least 1 dose of balovaptan. Subjects were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2527266|NCT03579719|Primary|Maximum Plasma Concentration (Cmax) for Balovaptan|Cmax is the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.|Day 10 of Period 1, Day 10 and Day 15 of Period 2|The Pharmacokinetic (PK) analysis population consisted of all subjects who received at least 1 dose of balovaptan. Subjects were excluded from the PK analysis population if they significantly violated the inclusion or exclusion criteria, deviated significantly from the protocol, or if data were unavailable or incomplete.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2527267|NCT03579433|Primary|Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6|Visual acuity (VA) was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. 20/20 represents normal distance eyesight. No hypothesis testing of the primary endpoint was specified.|Month 6|The Per Protocol Analysis Set (PPS) includes all eyes with successful IOL implantation, T3-T6 and recommended by ORA and with no major protocol deviations and data at visit.|||percentage of eyes|eyes||Number
2527268|NCT03578926|Secondary|Comfortable Wearing Time|Comfortable daily wearing time (hours/day)|2 weeks||||hours/day||Standard Deviation|Mean
2527269|NCT03578926|Secondary|Wearing Time|Average daily wearing time (hours/day)|2 weeks||||hours/day||Standard Deviation|Mean
2527270|NCT03578926|Primary|Post Blink Movement|Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)|2 weeks||||units on a scale||Standard Deviation|Mean
2527271|NCT03578926|Primary|Post Blink Movement|Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)|Baseline||||units on a scale||Standard Deviation|Mean
2527272|NCT03578926|Primary|Corneal Coverage|Lens covering the cornea (Yes, No)|2 weeks||||Participants|||Count of Participants
2527273|NCT03578926|Primary|Corneal Coverage|Lens covering the cornea (Yes, No)|Baseline||||Participants|||Count of Participants
2527274|NCT03578926|Primary|Lens Centration|Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)|2 weeks||||Participants|||Count of Participants
2527275|NCT03578926|Primary|Lens Centration|Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)|Baseline||||Participants|||Count of Participants
2527276|NCT03578146|Secondary|Andexanet Total Volume of Distribution (Vss)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Vss was calculated using a non-compartmental approach.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|30 subjects who received andexanet were included in the andexanet PK analysis|||L||Standard Deviation|Mean
2527277|NCT03578146|Secondary|Andexanet Total Systemic Clearance (CL)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. CL was calculated using a non-compartmental approach, calculated as Dose/AUC0-inf|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|30 subjects who received andexanet were included in the andexanet PK analysis|||L/hr||Standard Deviation|Mean
2527278|NCT03578146|Secondary|Andexanet Apparent Terminal Elimination Half-life (t1/2)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. t1/2 was determined by linear regression of the log concentration on the terminal portion of the plasma concentration-time curve.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|30 subjects who received andexanet were included in the andexanet PK analysis|||hr||Standard Deviation|Mean
2527279|NCT03578146|Secondary|Andexanet Time of Maximum Observed Plasma Concentration (Tmax)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Tmax was taken directly from the raw data.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|30 subjects who received andexanet were included in the andexanet PK analysis|||hr||Full Range|Median
2527280|NCT03578146|Secondary|Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf )|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. AUC0-inf was calculated using a non-compartmental approach|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|30 subjects who received andexanet were included in the andexanet PK analysis|||ng*hr/mL||Standard Deviation|Mean
2527281|NCT03578146|Secondary|Andexanet Maximum Observed Plasma Concentration (Cmax)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|30 subjects who received andexanet were included in the andexanet PK analysis|||ng/mL||Standard Deviation|Mean
2527282|NCT03578146|Secondary|Efficacy: Percent Change From Baseline in Unbound Rivaroaxaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration|Unbound rivaroxaban concentrations was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Unbound plasma concentrations for rivaroxaban were determined by a rapid equilibrium dialysis method followed by Liquid Chromatography-Mass Spectometry assay.|Baseline to 2 minutes following the end of andexanet/placebo administration|45 subjects who received rivaroxaban were included in the rivaroxaban pharmacokinetics (PK) analysis|||Percent change in unbound apixaban conc.||Standard Deviation|Mean
2527283|NCT03578146|Secondary|Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration|Thrombin generation was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Thrombin generation was measured using a TF-initiated thrombin generation assay.|Baseline to 2 minutes following the end of andexanet/placebo administration|45 subjects who received andexanet or placebo were included in the PD analysis|||Percent change in thrombin generation||Standard Deviation|Mean
2527284|NCT03578146|Primary|Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration|Anti-fXa activity was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Anti-fXa activity was measured using a commercial kit (Coamatic Heparin-82 33 9363, DiaPharma)|Baseline to 2 minutes following the end of andexanet/placebo administration|45 subjects who received andexanet or placebo were included in the pharmacodynamics (PD) analysis|||Percent change in anti-fXa activity||Standard Deviation|Mean
2527285|NCT03577275|Secondary|Change From Baseline in QRS Interval (QRS)|Electrocardiogram measurement of change from baseline in QRS interval (QRS)|2 hours|The data presented is from the 2 hour time point corresponding to T max|||msec||Standard Error|Least Squares Mean
2527287|NCT03577275|Secondary|Change From Baseline in Fridericia's Correction for QT Interval (QTcF)|Electrocardiogram measurement of change from baseline in Fridericia's correction for QT interval (QTcF)|24 hours|The largest change in QTcF for each arm during the study is presented below|||msec||Standard Error|Least Squares Mean
2527288|NCT03577275|Secondary|Change From Baseline in Heart Rate (HR)|Electrocardiogram measurement of change from baseline in heart rate (HR) maximum values presented|24 hours|maximum values of change in heart rate from baseline over the 24 hours post dose|||beats per minute||Standard Error|Least Squares Mean
2527289|NCT03577275|Primary|Change From Baseline in Fridericia's Correction for QT Interval (QTcF)|Electrocardiogram measurement of the maximum absolute change from baseline in Fridericia's correction for QT interval (QTcF)|24 hours|The primary endpoint for this trial was the placebo corrected change from baseline in QTcF. The data presented here are the maximum absolute change from baseline for placebo, moxifloxacin 400mg, NST-4016 600mg and NST-4016 2000mg.|||msec||Standard Error|Least Squares Mean
2527290|NCT03575962|Secondary|Number of Participants With the Indicated Assessment Events of Suicidal Behavior (SB) and Suicidal Ideation (SI) Via the Columbia Suicide Severity Rating Scale (C-SSRS)|Assessment of suicidality was conducted using the C-SSRS, a brief questionaire designed to assess severity and change in suicidality by integrating both behavior and ideation using a semi-structured interview to probe participant responses.|Day 3 in each treatment period|Safety Population|||Participants|||Count of Participants
2527291|NCT03575962|Secondary|Temperature at Indicated Time-points|Vital sign including temperature was measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Mean and standard deviation have been presented.|Day -1, pre-dose, 2, 4, 6, 24 and 72 hours post-dose in each treatment period|Safety Population|||Celsius||Standard Deviation|Mean
2527292|NCT03575962|Secondary|Respiratory Rate (RR) at Indicated Time-points|Vital sign including RR was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Mean and standard deviation have been presented.|Day -1, pre-dose, 2, 4, 6, 24 and 72 hours post-dose in each treatment period|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Breaths per minute||Standard Deviation|Mean
2527293|NCT03575962|Secondary|Pulse Rate (PR) at Indicated Time-points|Vital sign including PR was measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Mean and standard deviation have been presented.|Day -1, pre-dose, 2, 4, 6, 24 and 72 hours post-dose in each treatment period|Safety Population.|||Beats per minute||Standard Deviation|Mean
2527294|NCT03575962|Secondary|Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points|Vital signs including DBP and SBP were measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Mean and standard deviation have been presented.|Day -1, pre-dose, 2, 4, 6, 24 and 72 hours post-dose in each treatment period|Safety Population|||Millimeters of mercury||Standard Deviation|Mean
2527295|NCT03575962|Secondary|Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters|A single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, QT corrected (QTc) and QT interval corrected for heart rate according to Fridericia's formula (QTcF) intervals. Clinically significant abnormal ranges were: PR: lower: <120 milliseconds (msec) and upper: >200 msec; QRS: lower: <60 msec and upper: >120 msec and QTcF: lower: <320 msec and upper: >450 msec. The number of participants with clinically significant abnormal findings for ECG parameters have been presented.|Day -1, pre-dose, 2, 4, 6, 24 and 72 hours post-dose in each treatment period|Safety Population|||Participants|||Count of Participants
2527296|NCT03575962|Secondary|Number of Participants With Urinalysis Results by Dipstick Method by Visit|"Urine samples were collected to assess urine bilirubin, urine glucose, urine ketones, urine leukocyte esterase (LE), urine nitrite, urine occult blood, urine protein, urobilinogen and monitor urine potential of hydrogen (pH). The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace and positive, indicating proportional concentrations in the urine sample. All the numeric result values >0 have been considered as positive."|Day -1 and Day 3|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2527297|NCT03575962|Secondary|Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria|Blood samples were collected to analyze the hematology parameters; Hematocrit (Hct), Hemoglobin (Hb), Leukocytes, Lymphocytes, Neutrophils and Platelets. PCI ranges were Hct (Male and Female [high: >0.54 proportion of red blood cells in blood]), Hb (Male and Female [high: >180 grams per liter]), lymphocytes (low: <0.8x10^9 cells per liter), neutrophils (low: <1.5x10^9 cells per liter), platelets (low: <100x10^9 cells per liter and high: >550x10^9 cells per liter) and leukocytes (low: <3x10^9 cells per liter and high: >12x10^9 cells per liter). Participants were counted in the worst case category such that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category.|Up to 22 days|Safety Population|||Participants|||Count of Participants
2527298|NCT03575962|Secondary|Change From Baseline in Clinical Chemistry Parameter; Protein|Blood samples were collected to analyze the clinical chemistry parameter; Protein. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-Dose visit value. Mean and standard deviation have been presented.|Baseline (Day -1) and Day 3|Safety Population|||Grams per liter||Standard Deviation|Mean
2527299|NCT03575962|Secondary|Change From Baseline in Clinical Chemistry Parameters; Bilirubin, Creatinine and Direct Bilirubin|Blood samples were collected to analyze the clinical chemistry parameters; Bilirubin, Creatinine and Direct Bilirubin. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-Dose visit value. Mean and standard deviation have been presented.|Baseline (Day -1) and Day 3|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2527353|NCT03573206|Secondary|Study Group Success Rate - No Protamine Group|No delay in Ambulation due to access site bleeding in subjects who receive heparin but are not reversed with protamine (per-patient analyses)|From time of final hemostasis through successful ambulation, assessed to be within 6 hours of final hemostasis||||Participants|||Count of Participants
2527300|NCT03575962|Secondary|Change From Baseline in Clinical Chemistry Parameters; Bicarbonate, Calcium, Chloride, Glucose (Fasting), Potassium, Sodium and Urea|Blood samples were collected to analyze the clinical chemistry parameters; Bicarbonate, Calcium, Chloride, Glucose (fasting), Potassium, Sodium and Urea. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-Dose visit value. Mean and standard deviation have been presented.|Baseline (Day -1) and Day 3|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2527301|NCT03575962|Secondary|Change From Baseline in Clinical Chemistry Parameters; Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)|Blood samples were collected to analyze the clinical chemistry parameters; ALT, ALP and AST. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-Dose visit value. Mean and standard deviation have been presented.|Baseline (Day -1) and Day 3|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||International units per liter||Standard Deviation|Mean
2527302|NCT03575962|Secondary|Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)|An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement.|Up to 25 days|Safety Population comprising of all randomized participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2527303|NCT03575962|Primary|Concentration at 24 Hours Post-dose (C24h) of GSK3640254 Following Single Oral Dose in Healthy Participants|Blood samples were collected at designated timepoints. PK parameters of GSK3640254 were calculated using non-compartmental methods. Geometric mean and % geometric coefficient of variation have been presented.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12 and 24 hours post-dose in each treatment period|PK Population|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2527304|NCT03575962|Primary|Time to Reach Maximum Observed Concentration (Tmax) of GSK3640254 Following Single Oral Dose in Healthy Participants|Blood samples were collected at designated timepoints. PK parameters of GSK3640254 were calculated using non-compartmental methods. Median and full range of Tmax have been presented.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours post-dose in each treatment period|PK Population|||Hours||Full Range|Median
2527305|NCT03575962|Primary|Maximum Observed Concentration (Cmax) of GSK3640254 Following Single Oral Dose in Healthy Participants|Blood samples were collected at designated timepoints. PK parameters of GSK3640254 were calculated using non-compartmental methods. Geometric mean and % geometric coefficient of variation have been presented. Statistical analysis of PK parameters was done using mixed effect model for evaluation of Frel. Point estimate and 90% CI for the ratio of geometric least square mean of the test mesylate salt capsule to the reference Hydrochloride capsule were calculated for Cmax.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours post-dose in each treatment period|PK Population|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2527306|NCT03575962|Primary|Area Under the Concentration-time Curve From Zero to Time of Last Sample Taken (AUC[0-t]) of GSK3640254 Following Single Oral Dose in Healthy Participants|Blood samples were collected at designated timepoints. PK parameters of GSK3640254 were calculated using non-compartmental methods. Geometric mean and % geometric coefficient of variation have been presented. Statistical analysis of PK parameters was done using mixed effect model for evaluation of relative bioavailability (Frel). Point estimate and 90% confidence interval (CI) for the ratio of geometric least square mean of the test mesylate salt capsule to the reference Hydrochloride capsule were calculated for AUC(0-t).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours post-dose in each treatment period|PK Population|||Hour*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2527307|NCT03575962|Primary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) of GSK3640254 Following Single Oral Dose in Healthy Participants|Blood samples were collected at designated timepoints. Pharmacokinetic (PK) parameters of GSK3640254 were calculated using non-compartmental methods. Geometric mean and percentage (%) geometric coefficient of variation have been presented.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours post-dose in each treatment period|PK Population comprising of participants in the Safety Population for whom at least one PK sample was obtained, analyzed and evaluable drug concentrations reported. Only those participants with data available at the specified data points were analyzed.|||Hour*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2527308|NCT03575871|Secondary|Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score at Week 2, 4, 8 and 12|"SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where 0 = no itch or no sleeplessness and 10 = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome."|Baseline, Weeks 2, 4, 8, and 12|Full analysis set included all randomized participants who received at least 1 dose of study medication.|||percent change||95% Confidence Interval|Least Squares Mean
2527354|NCT03573206|Secondary|Study Group Success Rate - No Urinary Catheter Group|No peri-procedural urinary catheter insertion required through successful Ambulation (per-patient analyses)|From start of procedure through successful ambulation, assessed to be within 6 hours of final hemostasis||||Participants|||Count of Participants
2528887|NCT03476278|Secondary|Mood State According to Gender|Patients' mood state according to gender|1 day||||Participants|||Count of Participants
2527309|NCT03575871|Secondary|Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) Sleep Loss at Weeks 2, 4, 8 and 12|"SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where 0 = no itch or no sleeplessness and 10 = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome."|Baseline, Weeks 2, 4, 8, and 12|Full analysis set included all randomized participants who received at least 1 dose of study medication.|||units on a scale||95% Confidence Interval|Least Squares Mean
2527310|NCT03575871|Secondary|Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Visual Analogue Scale (VAS) of Itch at Weeks 2, 4, 8 and 12|"SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where 0 = no itch or no sleeplessness and 10 = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome."|Baseline, Weeks 2, 4, 8, and 12|Full analysis set included all randomized participants who received at least 1 dose of study medication.|||units on a scale||95% Confidence Interval|Least Squares Mean
2527311|NCT03575871|Secondary|Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >=75% Improvement From Baseline at Week 2, 4, 8 and 12|"SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where 0 = no itch or no sleeplessness and 10 = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome."|Baseline, Weeks 2, 4, 8, and 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, Number Analyzed” signifies number of participants evaluable at the specified time points."|||percentage of participants||95% Confidence Interval|Number
2527312|NCT03575871|Secondary|Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8 and 12|"SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where 0 = no itch/no sleeplessness and 10 = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome."|Baseline, Weeks 2, 4, 8, and 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Number Analyzed” signifies number of participants evaluable at the specified time points.|||percentage of participants||95% Confidence Interval|Number
2527313|NCT03575871|Secondary|Percentage of Participants With Percentage Body Surface Area (%BSA) (From EASI) < 5% at Weeks 2, 4, 8 and 12|4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limb, 3.33% for trunk and 2.5% for lower limb. % BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.|Weeks 2, 4, 8, and 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, Number Analyzed” signifies number of participants evaluable at the specified time points."|||percentage of participants||95% Confidence Interval|Number
2527336|NCT03575702|Secondary|Change in the Mean Weekly Number of Incontinence Episodes at Week 12|The mean weekly number of incontinence episodes was calculated as the total number of episodes per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of weeks in the period.|Baseline and Week 12|The efficiency analysis was performed on the FAS (Full Analysis Set) population, which included all randomized patients who received at least one dose of the drug and had at least one efficiency evaluation after visit 2.|||incontinence episodes per week||Standard Deviation|Mean
2527355|NCT03573206|Primary|Major Venous Access Site Closure-related Complications - Safety|Rate of combined majors venous access site closure-related complications attributed directly to the closure method.|30 (+/- 10) days post-procedure||||Participants|||Count of Participants
2527314|NCT03575871|Secondary|Change From Baseline in the Percentage Body Surface Area (%BSA) Affected at Week 2, 4, 8, and 12|4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.|Baseline, Weeks 2, 4, 8, and 12|Full analysis set included all randomized participants who received at least 1 dose of study medication.|||percentage of BSA||95% Confidence Interval|Least Squares Mean
2527315|NCT03575871|Secondary|Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 8 and 12|EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.|Baseline, Weeks 2, 4, 8, and 12|Full analysis set included all randomized participants who received at least 1 dose of study medication.|||percent change||95% Confidence Interval|Least Squares Mean
2527316|NCT03575871|Secondary|Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement (EASI-100) From Baseline at Weeks 2, 4, 8 and 12|EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.|Baseline, Weeks 2, 4, 8, and 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, Number Analyzed” signifies number of participants evaluable at specified time points."|||percentage of participants||95% Confidence Interval|Number
2527317|NCT03575871|Secondary|Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement (EASI-90) From Baseline at Weeks 2, 4, 8 and 12|EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.|Baseline, Weeks 2, 4, 8, and 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, Number Analyzed” signifies number of participants evaluable at the specified time points."|||percentage of participants||95% Confidence Interval|Number
2527318|NCT03575871|Secondary|Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement (EASI-50) From Baseline at Weeks 2, 4, 8 and 12|EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.|Baseline, Weeks 2, 4, 8, and 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, Number Analyzed” signifies number of participants evaluable at the specified time points."|||percentage of participants||95% Confidence Interval|Number
2527337|NCT03575702|Secondary|Change in the Mean Number of Incontinence Episodes at Week 2, 4 and 8|Separately for daily, daytime and nighttime measurements.|Baseline and Week 2, 4 and 8|The efficiency analysis was performed on the FAS (Full Analysis Set) population, which included all randomized patients who received at least one dose of the drug and had at least one efficiency evaluation after visit 2.|||incontinence episodes per day||Standard Deviation|Mean
2527356|NCT03573206|Primary|Overall Procedure Success - Effectiveness|Final hemostasis at all venous access sites and freedom from major venous access site closure-related complications through 30 days follow-up|30 (+/- 10) days post-procedure||||Participants|||Count of Participants
2527319|NCT03575871|Secondary|Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) at Week 2, 4, 8 and 12|IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded soles, palms and scalp.|Weeks 2, 4, 8 and 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Number Analyzed” signifies number of participants evaluable at the specified time points.|||percentage of participants||95% Confidence Interval|Number
2527320|NCT03575871|Secondary|Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Weeks 2, 4 and 8|IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.|Baseline, Weeks 2, 4, and 8|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Number Analyzed” signifies the number of participants evaluable at specified time points.|||percentage of participants||95% Confidence Interval|Number
2527321|NCT03575871|Secondary|Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement (EASI-75) From Baseline at Weeks 2, 4 and 8|EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.|Baseline, Weeks 2, 4, and 8|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Number Analyzed” signifies the number of participants evaluable at specified time points.|||percentage of participants||95% Confidence Interval|Number
2527322|NCT03575871|Secondary|Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale (NRS) for Severity of Pruritus|Participants were asked to assess their worst itching/pruritus due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst itch imaginable), where higher scores indicated greater severity.|Baseline up to Day 15|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||days||Inter-Quartile Range|Median
2527323|NCT03575871|Secondary|Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 12|PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.|Baseline, Week 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2527324|NCT03575871|Secondary|Percentage of Participants Who Achieved at Least 4-Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Weeks 2, 4, 8 and 12|Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.|Baseline, Weeks 2, 4, 8 and 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2527338|NCT03575702|Secondary|Change in the Mean Nighttime Number of Incontinence Episodes at Week 12|The mean nighttime number of incontinence episodes was calculated as the total number of episodes from 11 pm to 7 am for the study period (between visits) divided by the number of days in the period.|Baseline and Week 12|The efficiency analysis was performed on the FAS (Full Analysis Set) population, which included all randomized patients who received at least one dose of the drug and had at least one efficiency evaluation after visit 2.|||nighttime incontinence episode per day||Standard Deviation|Mean
2527339|NCT03575702|Secondary|Change in the Mean Daytime Number of Incontinence Episodes at Week 12|The mean daytime number of incontinence episodes was calculated as the total number of episodes from 7 am to 11 pm for the study period (between visits) divided by the number of days in the period.|Baseline and Week 12|The efficiency analysis was performed on the FAS (Full Analysis Set) population, which included all randomized patients who received at least one dose of the drug and had at least one efficiency evaluation after visit 2.|||daytime incontinence episodes per day||Standard Deviation|Mean
2527325|NCT03575871|Primary|Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75 Percent (%) Improvement (EASI-75) From Baseline at Week 12|EASI evaluates severity of participants AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks] on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.|Baseline, Week 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2527326|NCT03575871|Primary|Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (>=) 2 Points Improvement From Baseline at Week 12|IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded soles, palms and scalp.|Baseline, Week 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2527327|NCT03575702|Other Pre-specified|Number of Patients With Clinically Significant Vital Signs Changes||Week 12 of treatment|Safety Population - All randomized patients taken at least one dose of investigational/reference drug|||Participants|||Count of Participants
2527328|NCT03575702|Other Pre-specified|Number of Patients With Clinically Significant Changes in ECG Parameters||Week 12 of treatment|Safety Population - All randomized patients taken at least one dose of investigational/reference drug|||Participants|||Count of Participants
2527329|NCT03575702|Other Pre-specified|Number of Patients With Clinically Significant Changes in Laboratory Parameters|Including blood chemistry, blood count and urinalysis|Week 8 and 12|Safety Population - All randomized patients taken at least one dose of investigational/reference drug|||Participants|||Count of Participants
2527330|NCT03575702|Other Pre-specified|Changes in the Volume of Residual Urine|Measured via the urine bladder ultrasound (US)|Baseline and Week 4, 8 and 12|Safety Population - All randomized patients taken at least one dose of investigational/reference drug|||ml||Standard Deviation|Mean
2527331|NCT03575702|Other Pre-specified|Number of Patients With Serious Adverse Events (SAEs)||Up to 35 days after the end of treatment|Safety Population - All randomized patients taken at least one dose of investigational/reference drug|||Participants|||Count of Participants
2527332|NCT03575702|Other Pre-specified|Number of Patients With Adverse Events (AEs)||Up to 35 days after the end of treatment|Safety Population - All randomized patients taken at least one dose of investigational/reference drug|||Participants|||Count of Participants
2527333|NCT03575702|Secondary|Change in the EQ-5D-based Quality of Life at Week 12|"The Euro Quality of Life five Dimensions questionnaire ( EQ-5D, version EQ-5D-5L) is a validated questionnaire for the assessment of health-related quality of life. It consists of a questionnaire and a visual analogue scale (EQ-VAS). The self-assessment questionnaire is self-reported description of the subject's current health in 5 dimensions i.e., mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The subject is asked to assess their own current level of function in each dimension by 5-level scale from no problems to significant problem grades. The EQ-VAS is a self-rated health status using a VAS in mm from 0 (the worse health status) to 100 (the best health status). The EQ-VAS records the subject's perceptions of their own current overall health quantitatively in mm and can be used to monitor changes with time. The results of patients assessment by VAS are presented."|Baseline and Week 12|The efficiency analysis was performed on the FAS (Full Analysis Set) population, which included all randomized patients who received at least one dose of the drug and had at least one efficiency evaluation after visit 2.|||score on a scale, mm||Standard Deviation|Mean
2527334|NCT03575702|Secondary|Changes in the Overactive Bladder Symptom Score According to Overactive Bladder (OAB) Awareness Tool Questionnaire at 2, 4, 8 and 12 Week|"Overactive bladder (OAB) Awareness Tool Questionnaire (version OAB-V8, containing 8 questions) is a validated questionnaire. Patient is asked to answer 8 questions concerning typical symptoms of OAB giving answers with a scale with minimum - 0 score defined as no bothering at all and maximmum - 5 score defined as a very big deal to assess the severity of these symptoms. All answers are simply summed to make a combined final score. Male participants should add 2 points to their final score. The final scores range from 0 to 40 (for women) and 42 (for men). The score equal to 8 and more is interpreted as high probability of OAB presence, with the higher scores indicating more bothersome symptoms of OAB."|Baseline and Week 2, 4, 8 and 12|The efficiency analysis was performed on the FAS (Full Analysis Set) population, which included all randomized patients who received at least one dose of the drug and had at least one efficiency evaluation after visit 2.|||scores on a scale||Standard Deviation|Mean
2527335|NCT03575702|Secondary|Change in the Mean Daily Number of Urination Episodes at Week 2, 4 and 8 Visit as Compared to the Treatment Initiation Visit|The mean daily number of incontinence episodes was calculated as the total number of episodes (on the basis of the data that patients entered into their diaries) per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of days in the period.|Baseline and Week 2, 4 and 8|The efficiency analysis was performed on the FAS (Full Analysis Set) population, which included all randomized patients who received at least one dose of the drug and had at least one efficiency evaluation after visit 2.|||urination episodes per day||Standard Deviation|Mean
2527340|NCT03575702|Secondary|Change in the Mean Daily Number of Incontinence Episodes at Week 12|The mean daily number of incontinence episodes was calculated as the total number of episodes (on the basis of the data that patients entered into their diaries) per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of days in the period.|Baseline and Week 12|The efficiency analysis was performed on the FAS (Full Analysis Set) population, which included all randomized patients who received at least one dose of the drug and had at least one efficiency evaluation after visit 2.|||incontinence episodes per day||Standard Deviation|Mean
2527341|NCT03575702|Primary|Change in the Mean Daily Number of Urination Episodes at Week 12|The mean daily number of urination episodes was calculated as the total number of episodes (on the basis of the data that patients entered into their diaries) per day (from 7 am to 7 am the next day) for the study period (between visits) divided by the number of days in the period.|Baseline and Week 12|The efficiency analysis was performed on the FAS (Full Analysis Set) population, which included all randomized patients who received at least one dose of the drug and had at least one efficiency evaluation after visit 2.|||urination episodes per day||Standard Deviation|Mean
2527342|NCT03574818|Primary|Surgically Resectable|Patients able to proceed to surgery after administering necitumumab in the neoadjuvant setting with gemcitabine and cisplatin in surgically resectable patients with stage IB with tumor size >4cm, II and potentially resectable IIIA squamous cell lung cancer.|up to 63 days||||Participants|||Count of Participants
2527343|NCT03574441|Secondary|Rate of Epidural Catheter Replacement|Frequency of epidural catheter replacement due to analgesic failure among the catheters in each arm|24 hours. The time from insertion to removal of catheter due to failure||||percentage of catheters|||Number
2527344|NCT03574441|Primary|Epidural Catheter Migration|Percentage of participants for whom catheter migration was observed|24 hours. The time from insertion to removal of catheter||||percentage patients catheter migration|||Number
2527345|NCT03573817|Primary|Number of Participants With Clinically Relevant Changes in Electrocardiogram Results|Clinically relevant changes identified based on change from baseline.|Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)|The populations for Arms 1 and 2 are made up of the same participants, however 4 participants dropped out prior to beginning Period 2. Similarly, the populations for Arms 3 and 4 are made up of the same participants, but one participant dropped out prior to beginning Period 2.|||Participants|||Count of Participants
2527346|NCT03573817|Primary|Number of Participants With Clinically Relevant Changes in Clinical Laboratory Measurements|Clinically relevant changes identified based on change from baseline. Laboratory Measures assessed included hematology and serum.|Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)|The populations for Arms 1 and 2 are made up of the same participants, however 4 participants dropped out prior to beginning Period 2. Similarly, the populations for Arms 3 and 4 are made up of the same participants, but one participant dropped out prior to beginning Period 2.|||Participants|||Count of Participants
2527347|NCT03573817|Primary|Number of Participants With Clinically Relevant Changes in Vital Sign Measurements|Clinically significant changes identified based on change from baseline. Vital signs measured included heart rate, systolic blood pressure and diastolic blood pressure.|Baseline to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)|The populations for Arms 1 and 2 are made up of the same participants, however 4 participants dropped out prior to beginning Period 2. Similarly, the populations for Arms 3 and 4 are made up of the same participants, but one participant dropped out prior to beginning Period 2.|||Participants|||Count of Participants
2527348|NCT03573817|Primary|Number of Participants Who Experienced at Least One Serious Treatment-Emergent Adverse Event|"A serious adverse event (SAE) was defined as any untoward medical occurrence occurring at any dose that resulted in any of the following outcomes:~Death~Life-threatening situation. Life-threatening refers to a situation in which the participant was at risk of death at the time of the event; it does not refer to an event which might have caused death if it were more severe~Inpatient hospitalization or prolongation of existing hospitalization~Congenital anomaly in the offspring of a participant who received study drug~Important medical events that may not result in death, be immediately life-threatening, or require hospitalization, could have been considered an SAE when, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition~A treatment-emergent SAE is an SAE that occurred after the participant has received the study drug."|Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)|The populations for Arms 1 and 2 are made up of the same participants, however 4 participants dropped out prior to beginning Period 2. Similarly, the populations for Arms 3 and 4 are made up of the same participants, but one participant dropped out prior to beginning Period 2.|||Participants|||Count of Participants
2527349|NCT03573817|Primary|Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event|An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment. A treatment-emergent AE is an AE that occurred after the participant has received the study drug.|Day 1 to End of Period 2, a Maximum of 42 days + 7 days follow-up (Each period was 21 days)|The populations for Arms 1 and 2 are made up of the same participants, however 4 participants dropped out prior to beginning Period 2. Similarly, the populations for Arms 3 and 4 are made up of the same participants, but one participant dropped out prior to beginning Period 2.|||Participants|||Count of Participants
2527350|NCT03573206|Secondary|Minor Venous Access Site Closure-related Complications|Rate of combined majors venous access site closure-related complications attributed directly to the closure method.|30 (+/- 10) days post-procedure||||limbs|limbs||Count of Units
2527351|NCT03573206|Secondary|Device Success|The ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Mid-Bore VVCS (per-access site analyses)|Evaluated for each access site immediately after device delivery is attempted, reported within 5 minutes of deployment||||devices|devices||Count of Units
2527352|NCT03573206|Secondary|Study Group Success Rate - Same Calendar Day Discharge Group|Discharge within the same calendar day from the start of the procedure without the need for re-hospitalization within 72 hours of hospital discharge due to access site complications (per-patient analyses)|Within 72 hours post-discharge||||Participants|||Count of Participants
2527357|NCT03572972|Secondary|Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis|Event rate was defined as number of events divided by 100 participant-years for first occurrence of other bleeding events after index date was reported. Other bleeding requiring hospitalization was identified using hospital claims which had other bleeding KCD code (D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938, N939, M250, R233, R040, R041, R042, R048, R049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Index date = the first prescription date of study drugs during intake duration.|Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)|OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.|||events per 100 participants-years|||Number
2527358|NCT03572972|Secondary|Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis|Event rate was defined as number of events divided by 100 participant-years for first occurrence of other bleeding events after index date was reported. Other bleeding requiring hospitalization was identified using hospital claims which had other bleeding KCD code (D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938, N939, M250, R233, R040, R041, R042, R048, R049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration.|Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)|OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.|||events per 100 participants-years|||Number
2527359|NCT03572972|Secondary|Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus NOAC Analysis|Event rate was defined as number of events divided by 100 participant-years for first occurrence of intracranial hemorrhage events after index date was reported. Intracranial hemorrhage requiring hospitalization was identified using hospital claims which had an intracranial hemorrhage KCD code (I60, I61, I62, I690, I691, I692, S064, S065, S066, and S068) and brain CT or MRI codes. Index date = the first prescription date of study drugs during intake duration.|Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)|OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.|||events per 100 participants-years|||Number
2527360|NCT03572972|Secondary|Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus Warfarin Analysis|Event rate was defined as number of events divided by 100 participant-years for first occurrence of intracranial hemorrhage events after index date was reported. Intracranial hemorrhage requiring hospitalization was identified using hospital claims which had an intracranial hemorrhage KCD code (I60, I61, I62, I690, I691, I692, S064, S065, S066, and S068) and brain CT or MRI codes. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration.|Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)|OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.|||events per 100 participants-years|||Number
2527361|NCT03572972|Secondary|Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis|Event rate was defined as number of events divided by 100 participant-years for first occurrence of GI bleeding events after index date was reported. GI bleeding requiring hospitalization was identified using hospital claims which had a GI bleeding KCD code (I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922). Index date = the first prescription date of study drugs during intake duration.|Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)|OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.|||events per 100 participants-years|||Number
2527362|NCT03572972|Secondary|Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis|Event rate was defined as number of events divided by 100 participant-years for first occurrence of GI bleeding events after index date was reported. GI bleeding requiring hospitalization was identified using hospital claims which had a GI bleeding KCD code (I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922). Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration.|Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)|OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.|||events per 100 participants-years|||Number
2527387|NCT03570658|Secondary|Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity (AUC0-inf)||At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)|PK sampling was performed only once for single-dose (SAD) cohorts and did not include the placebo arms.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2527388|NCT03570658|Secondary|Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration (AUClast) of RO7049389||At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)|PK sampling was performed only once for single-dose (SAD) cohorts and did not include the placebo arms.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2527363|NCT03572972|Secondary|Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis|Event rate was defined as number of events divided by 100 participant-years for first occurrence of systemic embolism. Systemic embolism requiring hospitalization was identified using hospital claims which had systemic embolism KCD code = I74. For systemic embolism, hospitalization and any CT or MRI codes was used. Index date= the first prescription date of study drugs during intake duration.|Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)|OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.|||events per 100 participants-years|||Number
2527364|NCT03572972|Secondary|Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis|Event rate was defined as number of events divided by 100 participant-years for first occurrence of systemic embolism. Systemic embolism requiring hospitalization was identified using hospital claims which had systemic embolism KCD code = I74. For systemic embolism, hospitalization and any CT or MRI codes was used. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration|Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)|OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.|||events per 100 participants-years|||Number
2527365|NCT03572972|Secondary|Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis|Event rate was defined as number of events divided by 100 participant-years for first occurrence of ischemic stroke events after index date was reported. Ischemic stroke requiring hospitalization was identified using hospital claims which had ischemic stroke KCD code (G459, I63, and I693). For ischemic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration.|Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)|OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.|||events per 100 participants-years|||Number
2527366|NCT03572972|Secondary|Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis|Event rate was defined as number of events divided by 100 participant-years for first occurrence of ischemic stroke events after index date was reported. Ischemic stroke requiring hospitalization was identified using hospital claims which had ischemic stroke KCD code (G459, I63, and I693). For ischemic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration.|Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)|OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.|||events per 100 participants-years|||Number
2527367|NCT03572972|Secondary|Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis|Event rate was defined as number of events divided by 100 participant-years for first occurrence of hemorrhagic stroke events after index date was reported. Hemorrhagic stroke requiring hospitalization was identified using hospital claims which had a hemorrhagic stroke KCD code (I60-62, I690-692). For hemorrhagic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration.|Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)|OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.|||events per 100 participants-years|||Number
2527368|NCT03572972|Secondary|Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis|Event rate was number of events divided by 100 participant-years for first occurrence of hemorrhagic stroke events after index date was reported. Hemorrhagic stroke requiring hospitalization was identified using hospital claims which had a hemorrhagic stroke KCD code (I60-62, I690-692). For hemorrhagic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration.|Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)|OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.|||events per 100 participants-years|||Number
2527375|NCT03571607|Secondary|Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination|OPA GMFRs were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFRs were computed as the fold rise in titer value at 1 month after vaccination compared to baseline (pre-vaccination). The CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean difference of the log-transformed assay results before vaccination and 1 month after vaccination.|Pre-vaccination to 1 month after vaccination|Evaluable immunogenicity set: Eligible participants received study vaccine,took no prohibited vaccine,had blood drawn in specified time frame had atleast 1 valid,determinate OPA titer/IgG concentration result for atleast 1 serotype 1 month after vaccination,no major protocol violation. Number analyzed=participant evaluable for specified row.|||fold rise||95% Confidence Interval|Geometric Mean
2527389|NCT03570658|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of RO7049389||At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)|PK sampling was performed only once for single-dose (SAD) cohorts and did not include the placebo arms.|||Hours (h)||Full Range|Median
2527369|NCT03572972|Primary|Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis|Event rate was defined as number of events divided by 100 participant-years. Intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding and other bleeding requiring hospitalization identified using hospital claims which had ICH, GI and other bleeding KCD code whichever came first (first occurred event used). KCD code: ICH = I60-62, I690-92, S064-66, S068; GI bleeding = I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922; other bleeding = D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938-939, M250, R233, R040-042, R048-049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Brain CT/MRI codes were used for ICH only. Index date = the first prescription date of study drugs during intake duration.|Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)|OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.|||events per 100 participants-years|||Number
2527370|NCT03572972|Primary|Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis|Event rate: number of events divided by 100 participant-years. Intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding and other bleeding requiring hospitalization identified using hospital claims which had ICH, GI and other bleeding KCD code whichever came first (first occurred event used). KCD code: ICH = I60-62, I690-92, S064-66, S068; GI bleeding = I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922; other bleeding = D62,H448,H3572,H356,H313,H210,H113,H052,H470,H431,I312,N020-N029,N421,N831,N857,N920,N923,N930,N938-939,M250,R233,R040-042,R048-049,T792,T810,N950,R310, R311, R318, R58, T455, Y442, D683). Brain CT/MRI codes were used for ICH only. Index date= first prescription date of study drugs during intake duration. Participants were identified as NOAC user/Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration.|Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)|OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.|||events per 100 participants-years|||Number
2527371|NCT03572972|Primary|Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis|Event rate was defined as number of events divided by 100 participant-years. Hemorrhagic stroke, ischemic stroke and systemic embolism requiring hospitalization identified using hospital claims which had hemorrhagic, ischemic stroke or systemic embolism Korean standard classification of diseases (KCD) code, whichever came first (first occurred event used). KCD code: hemorrhagic stroke = I60-62, I690-692; ischemic stroke = G459, I63, I693; systemic embolism = I74. Hospitalization and brain CT/MRI codes were used for ischemic stroke, hemorrhagic stroke.Hospitalization and any CT/MRI codes were used for systemic embolism. Index date = the first prescription date of study drugs during intake duration.|Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)|OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.|||events per 100 participants-years|||Number
2527372|NCT03572972|Primary|Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis|Event rate was defined as number of events divided by 100 participant-years. Hemorrhagic stroke, ischemic stroke and systemic embolism requiring hospitalization identified using hospital claims which had hemorrhagic, ischemic stroke or systemic embolism Korean standard classification of diseases (KCD) code, whichever came first (first occurred event used). KCD code: hemorrhagic stroke = I60-62, I690-692; ischemic stroke = G459, I63, I693; systemic embolism = I74. Hospitalization and brain CT/MRI codes were used for ischemic stroke, hemorrhagic stroke.Hospitalization and any CT/MRI codes were used for systemic embolism. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration.|Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)|OACs treatment-naive participants with NVAF, starting any OACs in intake duration; matched on propensity scores by IPTW method to balance participant characteristics among specified arms. It created virtual groups used in analysis here. No data for Aspirin arm: could not be matched using IPTW with other arms due to heterogeneity characteristics.|||events per 100 participants-years|||Number
2527373|NCT03571607|Secondary|GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination|IgG GMFRs were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFRs were computed as the fold rise in concentrations at 1 month after vaccination compared to baseline (pre-vaccination). The CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean difference of the log-transformed assay results before vaccination and 1 month after vaccination.|Pre- vaccination to 1 month after vaccination|Evaluable immunogenicity set: Eligible participants received study vaccine, took no prohibited vaccine, had blood drawn in specified time frame had atleast 1 valid, determinate OPA titer/IgG concentration result for atleast 1 serotype 1 month after vaccination, no major protocol violation.|||fold rise||95% Confidence Interval|Geometric Mean
2527374|NCT03571607|Secondary|Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination|Pneumococcal IgG antibody against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using direct binding Luminex assay. Results were expressed as IgG concentrations. IgG concentrations were logarithmically transformed for analysis; geometric means calculated and expressed as GMCs. Two (2)-sided 95% CIs were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed based on the Student t distribution.|Pre-vaccination and 1 month after vaccination|Evaluable immunogenicity set: Eligible participants received study vaccine, took no prohibited vaccine, had blood drawn in specified time frame had atleast 1 valid, determinate OPA titer/IgG concentration result for atleast 1 serotype 1 month after vaccination, no major protocol violation.|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
2527376|NCT03571607|Secondary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination|Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). Two (2)-sided 95% CIs were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed based on the Student t distribution. OPA titer was expressed as reciprocal of highest serum dilution.|Pre-vaccination and 1 month after vaccination|Evaluable immunogenicity population: eligible participants who received the study vaccine and took no prohibited vaccines, had blood drawn within 1 month after vaccination with at least 1 valid and determinate assay and had no major protocol violations. Here, “Number analyzed” signifies participants evaluable for each specified row.|||titers||95% Confidence Interval|Geometric Mean
2527377|NCT03571607|Primary|Percentage of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.|signing of informed consent form (Day 1) up to Day 43|Safety analysis set included all participants who received 1 dose of study vaccine.|||percentage of participants|||Number
2527378|NCT03571607|Primary|Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years|Systemic events included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain, and were recorded by using an e-diary. Use of antipyretic or pain medication was also collected by using an e-diary. Fever was graded as 37.5 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity).|Day 1 up to Day 14|Safety analysis set included all participants who received 1 dose of study vaccine. Here, “Number analyzed” signifies participants evaluable for each specified category.|||percentage of participants||95% Confidence Interval|Number
2527379|NCT03571607|Primary|Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years|Systemic events included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain, and were recorded by using an e-diary. Use of antipyretic or pain medication was also collected by using an e-diary. Fever was graded as 37.5 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (greater than or equals to [>=] 6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity).|Day 1 up to Day 7|Safety analysis set included all participants who received 1 dose of study vaccine. Here, “Number analyzed” signifies participants evaluable for each specified category.|||percentage of participants||95% Confidence Interval|Number
2527380|NCT03571607|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years|Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (2.5 to 5.0 cm), moderate (>5.0 to 10.0 cm) and, severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).|Day 1 up to Day 14|Safety analysis set included all participants who received 1 dose of study vaccine. Here, “Number analyzed” signifies participants evaluable for each specified category.|||percentage of participants||95% Confidence Interval|Number
2527381|NCT03571607|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years|Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.0 centimeter [cm]), moderate (greater than [>] 2.0 to 7.0 cm) and severe (>7.0 cm) for participants aged 6 to <12 years, and as mild (2.5 to 5.0 cm), moderate (>5.0 to 10.0 cm) and, severe (>10.0 cm) for participants aged 12 to <18 years. Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).|Day 1 up to Day 7|Safety analysis set included all participants who received 1 dose of study vaccine. Here, “Number analyzed” signifies participants evaluable for each specified category.|||percentage of participants||95% Confidence Interval|Number
2527382|NCT03570658|Secondary|Area Under the Concentration vs Time Curve for a Dosing Interval (AUCtau)||At pre-defined intervals on Day 14 (MAD)|This parameter was not collected for SAD cohorts.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2527383|NCT03570658|Secondary|Accumulation Index of RO7049389||At pre-defined intervals on Day 14 (MAD)|This parameter was not collected for SAD cohorts.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2527384|NCT03570658|Secondary|Trough Plasma Concentration (Ctrough) of RO7049389||At pre-defined intervals on Day 14 (MAD)|This outcome measure applied to arms receiving RO7049389 during the MAD phase.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2527385|NCT03570658|Secondary|Clearance (CL/F) of RO7049389||At pre-defined intervals on Day 1 (SAD)|This parameter was not collected for the MAD cohort.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2527386|NCT03570658|Secondary|Apparent Half-Life (T1/2) of RO7049389||At pre-defined intervals on Day 1 (SAD) and Day 14 (MAD)|PK sampling was performed only once for single-dose (SAD) cohorts and did not include the placebo arms.|||Hours (h)||Geometric Coefficient of Variation|Geometric Mean
2527391|NCT03570658|Primary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|From the date of first administered dose through 28 days after the last administered dose.|All safety analyses were based on the safety analysis population, which included all subjects that received at least one dose of study medication (RO7049389 or placebo), with at least one safety assessment.|||Percentage of Participants|||Number
2527392|NCT03570255|Primary|Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation|Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the root mean square (RMS) error value. In order to obtain the RMS value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for each sample, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value.|up to 8 hours|Subject 7 & 11: Protocol deviation Subject 19 & 26: Outlier data points Subject 5: Removed per ISO standard for SpO2 equal to 100.|||percent of oxygen saturated hemoglobin|||Number
2527393|NCT03570047|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Any Intracranial Hemorrhage Event After Index Date|"Event rate per 100 participant-years for first occurrence of any intracranial hemorrhage event after index date was reported. Any intracranial hemorrhage was defined by ICD-10 diagnosis codes and participants were considered to have any intracranial hemorrhagic event if pre-defined any intracranial hemorrhagic-associated ICD-10 diagnosis codes appeared in the records. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm."|During the observation period of approximately 7 years|OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the “units analyzed” field.|||Events Per 100 Participant-Years|Pseudo datasets||Number
2527394|NCT03570047|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Major Intracranial Hemorrhage Events After Index Date|"Event rate per 100 participant-years for first occurrence of major intracranial hemorrhage events after index date was reported. Major intracranial hemorrhage was defined by ICD-10 diagnosis codes and participants were considered to have major intracranial hemorrhage if pre-defined major intracranial hemorrhagic-associated ICD-10 diagnosis codes appeared in the records. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm."|During the observation period of approximately 7 years|OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the “units analyzed” field.|||Events Per 100 Participant-Years|Pseudo datasets||Number
2527395|NCT03570047|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Any Gastrointestinal Bleeding Event After Index Date|Event rate per 100 participant-years for first occurrence of any gastrointestinal bleeding event after index date was reported. Any gastrointestinal bleeding was defined by ICD-10 diagnosis codes. If participants had ICD-10 diagnosis codes which suggest bleeding from the gastrointestinal tract, they were considered to have any gastrointestinal bleeding. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.|During the observation period of approximately 7 years|OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the “units analyzed” field.|||Events Per 100 Participant-Years|Pseudo datasets||Number
2527396|NCT03570047|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Major Gastrointestinal Bleeding Events After Index Date|"Event rate per 100 participant-years for first occurrence of major gastrointestinal bleeding events after index date was reported. Major gastrointestinal bleeding after index date was identified using hospital claims which had a gastrointestinal bleeding diagnosis code as the first listed ICD-10 diagnosis code. An event occurrence of major bleeding was defined as that appears as 21: Disease name behind hospitalization in database. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm."|During the observation period of approximately 7 years|OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the “units analyzed” field.|||Events Per 100 Participant-Years|Pseudo datasets||Number
2527403|NCT03569202|Post-Hoc|Change From Baseline Tear Osmolarity in Hyperosmolar Participants|Instrumental assay of tear fluid osmolarity (mOsm/L) in a hyperosmolar subgroup of participants (mean of eyes ≥308 mOsm/L)|From baseline to Day 30 (Part 3)|ITT population with hyperosmolar tears (mean of eyes ≥308 mOsm/L)|||mOsm/L||Standard Deviation|Mean
2527404|NCT03569202|Other Pre-specified|Change From Baseline Intraocular Pressure|Intraocular pressure measured using Goldmann applanation tonometry (mmHg)|From baseline to Day 30 (Part 3)|Safety dataset|||mmHg||Standard Deviation|Mean
2527397|NCT03570047|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Systemic Embolism Events After Index Date|Event rate per 100 participant-years for first occurrence of systemic embolism events after index date was reported. Systemic embolism events included any of the following: abdominal aortic embolism, aortic embolism, acute arterial occlusive disease of arteries of upper extremities, femoral arterial occlusion and acute arterial occlusive disease of arteries of lower extremities, iliac artery embolism, hepatic artery embolism, thromboembolism, embolic infarction, aortic embolism, subclavian artery stenosis. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.|During the observation period of approximately 7 years|OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the “units analyzed” field.|||Events Per 100 Participant-Years|Pseudo datasets||Number
2527398|NCT03570047|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Hemorrhagic Stroke After Index Date|Event rate per 100 participant-years for first occurrence of hemorrhagic stroke after index date was reported. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.|During the observation period of approximately 7 years|OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the “units analyzed” field.|||Events Per 100 Participant-Years|Pseudo datasets||Number
2527399|NCT03570047|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Ischemic Stroke After Index Date|Event rate per 100 participant-years for first occurrence of ischemic stroke after index date was reported. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.|During the observation period of approximately 7 years|OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the “units analyzed” field.|||Events Per 100 Participant-Years|Pseudo datasets||Number
2527400|NCT03570047|Primary|Event Rate Per 100 Participant-Years For First Occurrence of Any Bleeding Event After Index Date|"Event rate per 100 participant-years for first occurrence of any bleeding event after index date was reported. Any bleeding was defined using ICD-10 diagnosis codes and participants were considered to have any bleeding if pre-defined bleeding-associated ICD-10 diagnosis codes appeared in the records. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm."|During the observation period of approximately 7 years|OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the “units analyzed” field.|||Events Per 100 Participant-Years|Pseudo datasets||Number
2527401|NCT03570047|Primary|Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date|"Event rate per 100 participant-years for first occurrence of major bleeding event after index date was reported. Major bleeding after index date was identified using hospital claims which had a bleeding diagnosis code as the first listed in International Statistical Classification of Diseases and Related Health Problems (ICD)-10 diagnosis code. An event occurrence of major bleeding was defined as that appears as 21: Disease name behind hospitalization in database. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm."|During the observation period of approximately 7 years|OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the “units analyzed” field.|||Events Per 100 Participant-Years|Pseudo datasets||Number
2527402|NCT03570047|Primary|Event Rate Per 100 Participant-Years For First Occurrence of Stroke and Systemic Embolism Events After Index Date|Event rate per 100 participant-years for first occurrence of stroke and systemic embolism events after index date was reported. Stroke events included the composite of any ischemic and any hemorrhagic stroke events (non-traumatic extradural hemorrhage). Systemic embolism events were defined as any of the following: abdominal aortic embolism, aortic embolism, acute arterial occlusive disease of arteries of upper extremities, femoral arterial occlusion and acute arterial occlusive disease of arteries of lower extremities, iliac artery embolism, hepatic artery embolism, thromboembolism, embolic infarction, aortic embolism, subclavian artery stenosis. Index date was defined as date of first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.|During the observation period of approximately 7 years|OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the “units analyzed” field.|||Events Per 100 Participant-Years|Pseudo datasets||Number
2527405|NCT03569202|Other Pre-specified|Change From Baseline Lid Redness|"Eyelid redness score is assessed on an ordinal scale of 0 to 4 (IER grading scale):~0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness."|From baseline to Day 30 (Part 3)|Safety dataset|||score on a scale||Standard Deviation|Mean
2527406|NCT03569202|Other Pre-specified|Change From Baseline Conjunctival Redness|"Conjunctival redness score is assessed on an ordinal scale of 0 to 4 (IER grading scale):~0 = not existing, 1 = very slight, 2 = slight, 3 = moderate, 4 = severe. Higher score represents more intense redness."|From baseline to Day 30 (Part 3)|Safety dataset|||score on a scale||Standard Deviation|Mean
2527407|NCT03569202|Other Pre-specified|Change From Baseline Visual Acuity|Best corrected visual acuity (ETDRS charts 1 & 2, 2000 series)|From baseline to Day 30 (Part 3)|Safety dataset|||logMAR chart log units||Standard Deviation|Mean
2527408|NCT03569202|Secondary|Change From Baseline Conjunctival (Nasal) Staining|Conjunctival staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining.|From baseline to Day 30 (Part 3)|Per-protocol (PP) dataset|||score on a scale||Standard Deviation|Mean
2527409|NCT03569202|Secondary|Change From Baseline Conjunctival (Temporal) Staining|Conjunctival staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining.|From baseline to Day 30 (Part 3)|Per-protocol (PP) dataset|||score on a scale||Standard Deviation|Mean
2527410|NCT03569202|Secondary|Change From Baseline Corneal Staining|Corneal staining score is assessed as the average number of punctate dots on an ordinal scale of 0, 1, 2, 3, 4, and 5 (Oxford scale) when compared to a pictorial standard. The number of dots increases on a log scale. Higher score represents more intense staining.|From baseline to Day 30 (Part 3)|Per-protocol (PP) dataset|||score on a scale||Standard Deviation|Mean
2527411|NCT03569202|Secondary|Change From Baseline Ocular Protection Index (OPI)|OPI is the ratio of TBUT/IBI (IBI, interblink interval calculated from blink rate). An OPI value >1 indicates that TBUT (s) exceeds IBI (s) and that the ocular surface is mostly tear-film protected, because tear film break-ups do not take place within spontaneous blink cycles.|From baseline to Day 30 (Part 3)|Intent-to-treat (ITT) dataset|||ratio||Standard Deviation|Mean
2527412|NCT03569202|Secondary|Change From Baseline Blink Rate|Measurement of spontaneous eyelid blinks per minute|From baseline to Day 30 (Part 3)|Intent-to-treat (ITT) dataset|||Blinks/min||Standard Deviation|Mean
2527413|NCT03569202|Primary|Change From Baseline TBUT|Tear film break-up time (TBUT) (s)|From baseline to Day 30 (Part 3)|Intent-to-treat (ITT) dataset|||s||Standard Deviation|Mean
2527414|NCT03569202|Primary|Change From Baseline Tear Osmolarity|Instrumental assay of tear fluid osmolarity (mOsm/L)|From baseline to Day 30 (Part 3)|Intent-to-treat (ITT) dataset|||mOsm/L||Standard Deviation|Mean
2527415|NCT03569202|Primary|Change From Baseline OSDI|Ocular Surface Disease Index (OSDI) is a questionnaire consisting of 12 questions subdivided into 3 subscales for measuring the frequency of dry eye symptoms, vision-related quality of life and environmental triggers during the previous week. Answers to each question are on a scale of 0 (None of the time) to 4 (All of the time). Both total OSDI and its subscale scores are on a scale of 0 to 100, calculated as follows: score = (sum of scores for questions answered/number of questions answered) x 25. Higher scores represent greater disability.|From baseline to Day 30 (Part 3)|Intent-to-treat (ITT) dataset|||units on a scale||Standard Deviation|Mean
2527416|NCT03569033|Secondary|Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)|An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Up to Day 7|All randomized participants who received at least 1 dose of study treatment|||Percentage of participants|||Number
2527417|NCT03569033|Secondary|Percentage of Participants Who Experienced One or More Adverse Events (AEs)|An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Up to 21 days|All randomized participants who received at least 1 dose of study treatment|||Percentage of participants|||Number
2527418|NCT03569033|Secondary|Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3|The LCQ-Acute is a 19-item health-related quality-of-life (HRQoL) questionnaire specific for acute cough which contains three domains (i.e., physical, psychological, and social). It is calculated as a mean score for each domain ranging from 1 to 7, and total score ranging from 3 to 21. Each item on the LCQ-acute assesses symptoms or the impact of symptoms on HRQoL in the last 24 hours using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. Participants' perception of their cough severity was assessed, based on the LCQ-Acute score, at Baseline and on Day 3.|Baseline and Day 3|All randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with HRV-16|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2527419|NCT03569033|Secondary|Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3|"The Mean Total Daily CSD Score is calculated using the daily CSD instrument, a 7-item, disease-specific, patient-reported outcome measure with a recall period of today (the current day). The measure evaluates frequency of cough (3 items); intensity of cough (2 items); and disruption due to cough (2 items). Each of these 7 items is rated on an 11-point scale, ranging from 0 (best) to 10 (worst), with higher scores indicating greater severity. The total daily CSD score is the sum of these 7 item scores (Min=0, Max=70). The Mean Total Daily CSD Score (the sum of these 7 item scores divided by 7) was calculated at Baseline and on Day 3."|Baseline and Day 3|All randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with HRV-16|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2527978|NCT03535844|Primary|Change in Plasma Nitric Oxide|Concentrations of plasma total nitrate/nitrite using commercially available ELISA assay kits.|Pre- and post-intervention (Week 16)||||nmol/mL||Standard Deviation|Mean
2527420|NCT03569033|Secondary|Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3|The Cough Severity VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline and on Day 3.|Baseline and Day 3|All randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with HRV-16|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2527421|NCT03569033|Primary|Awake Coughs Per Hour on Day 3|Awake cough frequency (coughs per hour) was assessed by an objective digital cough-counting device (VitaloJAK™ cough monitor) on Day 3.|Day 3|All randomized participants who received at least 1 dose of trial intervention and had confirmation of viral shedding at 72 hours post inoculation with human rhinovirus type 16 (HRV-16)|||Coughs per hour||95% Confidence Interval|Least Squares Mean
2527422|NCT03568942|Secondary|Number of Participants With Abnormal Physical Examination Findings|Physical examinations included assessments of the respiratory, cardiovascular, abdominal, gastrointestinal, neurological and urogenital systems. This analysis was planned but data was not collected and captured in the database.|Up to Day 31|Safety Population. This analysis was planned but data was not collected and captured in the database.||||||
2527423|NCT03568942|Secondary|Number of Participants With Urinalysis Dipstick Results: Protein|Urine samples were collected at indicated time points to analyze parameter including protein by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative indicates <10 mg/dL, 1+ indicates 30 mg/dL and 2+ indicates 100 mg/dL in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented.|Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)|Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2527424|NCT03568942|Secondary|Number of Participants With Urinalysis Dipstick Results: Occult Blood|Urine samples were collected at indicated time points to analyze parameter including occult blood by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Small indicates 25 Erythrocytes per microliter (Ery/mcL), Moderate indicates 50 Ery/mcL and Large indicates 250 Ery/mcL in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented.|Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)|Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2527425|NCT03568942|Secondary|Number of Participants With Urinalysis Dipstick Results: Leukocyte Esterase|Urine samples were collected at indicated time points to analyze parameter including leukocyte esterase by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, Trace indicates 15 Leukocytes per microliter (Leuko/mcL), Small indicates 70 Leuko/mcL, Moderate indicates 125 Leuko/mcL and Large indicates 500 Leuko/mcL in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented.|Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)|Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2527426|NCT03568942|Secondary|Number of Participants With Urinalysis Dipstick Results: Ketones|Urine samples were collected at indicated time points to analyze parameter including ketones by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative, 5 indicates 5 milligrams per deciliter (mg/dL) and 20 indicates 20 mg/dL in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented.|Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)|Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2527427|NCT03568942|Secondary|Number of Participants With Urinalysis Dipstick Results: Glucose and Nitrites|Urine samples were collected at indicated time points to analyze parameters including glucose and nitrites by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative and positive in the urine sample. Baseline was defined as Day -1. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13. Only categories with significant values have been presented.|Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)|Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2527428|NCT03568942|Secondary|Change From Baseline in Clinical Chemistry Parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea|Blood samples were collected to analyze the chemistry parameters: Glucose, Calcium, Chloride, Potassium, Sodium and Urea. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.|Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)|Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2527429|NCT03568942|Secondary|Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (ALP)|Blood samples were collected to analyze the chemistry parameters: ALT, AST and ALP. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.|Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)|Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||International units per liter||Standard Deviation|Mean
2527979|NCT03535844|Primary|Change in Flow Mediated Dilation|Brachial artery flow mediated dilation measured using high-frequency ultrasonographic imaging|Pre- and post-intervention (Week 16)||||% dilation||Standard Deviation|Mean
2527430|NCT03568942|Secondary|Change From Baseline in Clinical Chemistry Parameters: Creatinine and Bilirubin|Blood samples were collected to analyze the chemistry parameters: Creatinine and Bilirubin. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.|Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)|Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2527431|NCT03568942|Secondary|Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein|Blood samples were collected to analyze the chemistry parameters: Albumin and Protein. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.|Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)|Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2527432|NCT03568942|Secondary|Change From Baseline in Hematology Parameter: Red Blood Cell Count|Blood samples were collected to analyze the hematology parameter: Red blood cell count. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.|Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)|Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||10^12 cells per liter||Standard Deviation|Mean
2527433|NCT03568942|Secondary|Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume|Blood samples were collected to analyze the hematology parameter: Erythrocyte Mean Corpuscular Volume. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.|Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)|Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Femtoliter||Standard Deviation|Mean
2527434|NCT03568942|Secondary|Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Hemoglobin|Blood samples were collected to analyze the hematology parameter: Erythrocyte Mean Corpuscular Hemoglobin. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.|Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)|Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Picogram||Standard Deviation|Mean
2527435|NCT03568942|Secondary|Change From Baseline in Hematology Parameter: Hematocrit|Blood samples were collected to analyze the hematology parameter: Hematocrit. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.|Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)|Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Percentage of red blood cells in blood||Standard Deviation|Mean
2527436|NCT03568942|Secondary|Change From Baseline in Hematology Parameter: Hemoglobin|Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.|Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)|Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Grams per liter||Standard Deviation|Mean
2527437|NCT03568942|Secondary|Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet Counts|Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet counts. Baseline was defined as Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.|Baseline, Day 3, Day 5 and Days 10 to 13 (Test-of-cure visit)|Safety Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||10^9 cells per liter||Standard Deviation|Mean
2527438|NCT03568942|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF)|A 12-lead ECG was measured in semi-supine position using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF. Baseline was defined as the latest non-missing value at Day -1 or at Day 1 pre-dose. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline; Day 1: 2 hours; Day 4: pre-dose and 2 hours|Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||Millisecond||Standard Deviation|Mean
2527439|NCT03568942|Secondary|Change From Baseline in Body Temperature|Vital sign including body temperature was measured in semi-supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was defined as the latest non-missing value at Day -1 or at Day 1 pre-dose. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.|Baseline, Day 2, Day 3, Day 4, Day 5 and Days 10 to 13 (Test-of-cure visit)|Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||Degree Celsius||Standard Deviation|Mean
2527980|NCT03535844|Primary|Change in Endothelial Progenitor Cells|Quantity and quality of circulating endothelial progenitor cells|Pre- and post-intervention (Week 16)||||cells||Standard Deviation|Mean
2527440|NCT03568942|Secondary|Change From Baseline in Pulse Rate|Vital sign including pulse rate was measured in semi-supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was defined as the latest non-missing value at Day -1 or at Day 1 pre-dose. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.|Baseline, Day 2, Day 3, Day 4, Day 5 and Days 10 to 13 (Test-of-cure visit)|Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||Beats per minute||Standard Deviation|Mean
2527441|NCT03568942|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital signs including SBP and DBP were measured in semi-supine position after 5 minutes of rest for the participants in a quiet setting without distractions. Baseline was defined as the latest non-missing value at Day -1 or at Day 1 pre-dose. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Assessment at Test-of-cure visit was conducted between any day of Days 10 to 13.|Baseline, Day 2, Day 3, Day 4, Day 5 and Days 10 to 13 (Test-of-cure visit)|Safety Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||Millimeters of mercury||Standard Deviation|Mean
2527442|NCT03568942|Secondary|Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious AEs (SAEs)|An AEs is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; and other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least 1 dose of gepotidacin.|Up to Day 31|Safety Population|||Participants|||Count of Participants
2527443|NCT03568942|Secondary|Urine Pre-dose Concentration (Ctau) of Gepotidacin|Urine samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.|Days 1 to 5: Pre-dose|PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2527444|NCT03568942|Secondary|Renal Clearance (CLr) of Gepotidacin|Urine samples were collected to evaluate the PK of gepotidacin at the indicated time points. CLr was calculated as CLr = Ae 12 hours/AUC(0-tau). The PK parameters were calculated by standard non-compartmental analysis.|Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose|PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2527445|NCT03568942|Secondary|Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Gepotidacin|Urine samples were collected to evaluate the PK of gepotidacin at the indicated time points. fe% was calculated as fe% = (Ae 12 hours/Dose) multiply by 100. The PK parameters were calculated by standard non-compartmental analysis.|Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose|PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Percentage of dose||Geometric Coefficient of Variation|Geometric Mean
2527446|NCT03568942|Secondary|Amount of Drug Excreted in Urine in a Time Interval (Ae[t1-t2]) of Gepotidacin|Ae(t1-t2) measure the amount of drug excreted in urine in a time intervals 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose on Days 1 and 4. The PK parameters were calculated by standard non-compartmental analysis.|Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose|PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||mg||Geometric Coefficient of Variation|Geometric Mean
2527447|NCT03568942|Secondary|Amount of Drug Excreted Over 12 Hours (Ae12hours) of Gepotidacin|Urine samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. Ae12hours was calculated by adding all the fractions of drug collected over all the allotted time intervals.|Days 1 and 4: Pre-dose and at 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 10 hours, and 10 to 12 hours post-dose|PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||mg||Geometric Coefficient of Variation|Geometric Mean
2527448|NCT03568942|Primary|Plasma Pre-dose Concentration (Ctau) of Gepotidacin|Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.|Days 1 to 5: Pre-dose|PK Parameter Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2527449|NCT03568942|Primary|Accumulation Ratio (Ro) of Gepotidacin|Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. Accumulation ratio (Ro) was calculated as ratio of AUC(0-tau) at Day 4 to AUC(0-tau) at Day 1.|Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose|PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2527450|NCT03568942|Primary|Apparent Steady State Clearance (CLss/F) of Gepotidacin|Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. CLss/F was calculated as Dose divided by AUC(0-tau).|Day 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose|PK Parameter Population. Only those participants with data available at the indicated time points were analyzed.|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2527451|NCT03568942|Primary|Time of Occurrence of Cmax (Tmax) of Gepotidacin|Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.|Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose|PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Hours||Full Range|Median
2527452|NCT03568942|Primary|Maximum Plasma Concentration (Cmax) of Gepotidacin|Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.|Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose|PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2527453|NCT03568942|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Zero (Pre-dose) Over the Dosing Interval (AUC[0-tau]) of Gepotidacin|Blood samples were collected to evaluate the PK of gepotidacin at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. PK Parameter Population consisted of all participants who received gepotidacin 1500 mg BID through the completion of all PK collections for whom valid and evaluable plasma PK parameters were derived for gepotidacin.|Days 1 and 4: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose|PK Parameter Population. All the participants in the study were analyzed (22 Participants) but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Hours* nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2527454|NCT03567005|Secondary|Overall Vision|Subjective rating of overall vision on a scale of 1 (Poor) to 10 (Excellent). Both eyes contributed to the analysis.|Day 7, each product|Full Analysis Set with non-missing response|||units on a scale||Standard Deviation|Mean
2527455|NCT03567005|Primary|Distance Visual Acuity (VA) (logMAR, OU)|VA was tested under photopic (well-lit) conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart positioned 6 meters from the subject. VA was collected bilaterally (OU) and measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower numeric value represents better visual acuity.|Day 7, each product|Full Analysis Set with non-missing response|||logMAR||Standard Deviation|Mean
2527456|NCT03566979|Secondary|Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments|Percentage of participants with confirmed perceptible pain relief from 45 minutes to successively earlier minutes in one-minute increments were reported.|Up to 45 minutes after dosing|Population analyzed included all randomized participants. Data for this outcome measure was planned to be analyzed and reported only for Placebo and Test NPX (440 mg) arms.|||Percentage of Participants|||Number
2527457|NCT03566979|Primary|Time to Confirmed Perceptible Pain Relief|Minutes until confirmed first perceptible pain relief was achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.|12 hours|Population analyzed included all randomized participants.|||Minutes||Full Range|Median
2527458|NCT03566810|Secondary|Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG) Findings|The 12-lead ECG recordings were obtained after 5 minutes of rest in a semi-supine position. ECG recordings included rhythm, ventricular rate, PR interval, QRS duration, QT and QTc intervals. Number of participants with clinically significant abnormalities in 12-lead ECG findings were reported. Clinically significance was decided by investigator.|Time from informed consent up to end of study (Day 15)|The Safety Analysis Set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2527459|NCT03566810|Secondary|Number of Participants With Clinically Significant Abnormalities in Physical Examination Findings|Physical examination included assessments of the general appearance, skin and mucosa, superficial lymph nodes, head and neck, chest, abdomen, musculoskeletal, and neurological systems. Number of participants with clinically significant abnormalities in physical examination findings were reported. clinically significance was decided by investigator.|Time from informed consent up to end of study (Day 15)|The Safety Analysis Set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2527460|NCT03566810|Secondary|Number of Participants With Clinically Significant Abnormalities in Laboratory Values|The laboratory measurements included hematology, blood chemistry and urinalysis. Number of participants with clinically significant abnormalities in laboratory values were reported. Clinically Significance was decided by investigator.|Time from informed consent up to end of study (Day 15)|The Safety Analysis Set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2527461|NCT03566810|Secondary|Number of Participants With Clinically Significant Abnormalities in Vital Signs|Vital sign assessment included blood pressure, pulse rate, body temperature and respiration (frequency per minute). Number of participants with clinically significant abnormalities in vital signs were reported. Clinically significance was decided by investigator.|Time from informed consent up to end of study (Day 15)|The Safety Analysis Set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2527471|NCT03566810|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of Metformin|Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14 post-dose on Day 1 and Day 8; 24, 30, 36 hours post-dose on Day 2 and 9; 48 hours post-dose on Day 3 and 10|The Pharmacokinetic (PK) Analysis Set included all participants who completed the study with adequate study drug compliance, without any relevant protocol violations or events with respect to factors likely to affect comparability of PK results, and with sufficient evaluable data to determine primary outcome measures for both treatments.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2527462|NCT03566810|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs|An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration. TEAEs included both Serious TEAEs and non-serious TEAEs.|Time from informed consent up to end of study (Day 15)|The Safety Analysis Set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2527463|NCT03566810|Secondary|Apparent Volume of Distribution at After Extravascular Administration (Vz/f) of Metformin|Vz/f is defined as the distribution of a study drug between plasma and the rest of the body after oral dosing.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14 post-dose on Day 1 and Day 8; 24, 30, 36 hours post-dose on Day 2 and 9; 48 hours post-dose on Day 3 and 10|The Pharmacokinetic analysis set. Here “Number of participants analyzed” signifies those participants who were evaluable for this outcome measure.|||liter||Geometric Coefficient of Variation|Geometric Mean
2527464|NCT03566810|Secondary|Total Body Clearance (CL/f) of Metformin|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14 post-dose on Day 1 and Day 8; 24, 30, 36 hours post-dose on Day 2 and 9; 48 hours post-dose on Day 3 and 10|The Pharmacokinetic analysis set. Here “Number of participants analyzed” signifies those participants who were evaluable for this outcome measure.|||liter per hour||Geometric Coefficient of Variation|Geometric Mean
2527465|NCT03566810|Secondary|Elimination Rate Constant (Lambda z) of Metformin|Lambda z was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14 post-dose on Day 1 and Day 8; 24, 30, 36 hours post-dose on Day 2 and 9; 48 hours post-dose on Day 3 and 10|As AUCextra was >20% of AUC0-inf, parameters derived from lambda z were regarded as unreliable estimate of the extent of exposure and not calculated as it was pre-specified to not report these data in this condition.||||||
2527466|NCT03566810|Secondary|Area Under the Plasma Concentration-Time Curve From Time Tlast Extrapolated to Infinity (AUCextra) of Metformin|AUCextra% was defined as area under the curve from time tlast extrapolated to infinity as percentage of AUC 0-infinity. Here, tlast is the last sampling time at which the concentration is at or above the lower limit of quantification.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14 post-dose on Day 1 and Day 8; 24, 30, 36 hours post-dose on Day 2 and 9; 48 hours post-dose on Day 3 and 10|As AUCextra was >20% of AUC0-inf, parameters derived from lambda z including AUCextra% were regarded as unreliable estimate of the extent of exposure and not calculated as it was pre-specified to not report these data in this condition.||||||
2527467|NCT03566810|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Metformin|AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ lambda z, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and lambda z is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14 post-dose on Day 1 and Day 8; 24, 30, 36 hours post-dose on Day 2 and 9; 48 hours post-dose on Day 3 and 10|The Pharmacokinetic analysis set. Here “Number of participants analyzed” signifies those participants who were evaluable for this outcome measure.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2527468|NCT03566810|Secondary|Apparent Terminal Half-Life (t1/2) of Metformin|Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by lambda z.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14 post-dose on Day 1 and Day 8; 24, 30, 36 hours post-dose on Day 2 and 9; 48 hours post-dose on Day 3 and 10|"The Pharmacokinetic analysis set. Here Number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||hours||Geometric Coefficient of Variation|Geometric Mean
2527469|NCT03566810|Secondary|Time to Reach Maximum Plasma Concentration of Metformin|Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14 post-dose on Day 1 and Day 8; 24, 30, 36 hours post-dose on Day 2 and 9; 48 hours post-dose on Day 3 and 10|The PK Analysis Set included all participants who completed the study with adequate study drug compliance, without any relevant protocol violations or events with respect to factors likely to affect comparability of PK results, and with sufficient evaluable data to determine primary outcome measures for both treatments.|||hours||Full Range|Median
2527470|NCT03566810|Primary|Maximum Observed Plasma Concentration (Cmax) of Metformin|Pharmacokinetic (PK) parameter Cmax was obtained directly from the concentration versus time curve.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14 post-dose on Day 1 and Day 8; 24, 30, 36 hours post-dose on Day 2 and 9; 48 hours post-dose on Day 3 and 10|The PK Analysis Set included all participants who completed the study with adequate study drug compliance, without any relevant protocol violations or events with respect to factors likely to affect comparability of PK results, and with sufficient evaluable data to determine primary outcome measures for both treatments.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2527472|NCT03565874|Secondary|Depression|"Depression symptoms will be assessed with a 13-item short form of the Beck Depression Inventory (BDI), which is a 13-item, self-report rating inventory that measures symptoms of depression. The scale for each item goes from 0 to 3.~Total score is calculated by adding up scores from each item (Min = 0, Max = 39).~Higher scores indicate a higher level of depression. A validated French version of the BDI will be used."|Before and after completing the HRVB program (on average 3 weeks).||||score on a scale||Standard Deviation|Mean
2527981|NCT03535844|Primary|Change in Carotid Intima Media Thickness|Carotid intima media thickness measured using high-frequency ultrasonographic imaging|Pre- and post-intervention (Week 16)||||mm||Standard Deviation|Mean
2527473|NCT03565874|Secondary|Anxiety|"Anxiety symptoms will be measured with the State and Trait Anxiety Inventory (STAI). STAI score is calculated on 40 items (20 items assessing trait anxiety and 20 items assessing state anxiety) rated on a 4 point Likert scale (from Almost never to Almost always). Total score for state and trait anxiety is calculated by adding up all items (Min = 20, Max = 80).~Higher scores indicate a higher level of anxiety. A validated French version of the STAI will be used."|Before and after completing the HRVB program (on average 3 weeks).||||score on a scale||Standard Deviation|Mean
2527474|NCT03565874|Secondary|PTSD|"Post-traumatic stress disorder symptoms will be measured with the Post-traumatic stress disorder checklist (PCL-5) for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5). PCL-5 is a 20 items self-report measure that assesses the presence and severity of PTSD symptoms. Items on the PCL-5 correspond to DSM-5 criteria for PTSD. Each item is rated on a 5 point Likert scale (from Not at all to Extremely). Total score is calculated by adding up scores for all items (Min = 0, Max = 80). Higher scores indicate a higher level of PTSD. A validated French version of the PCL will be used."|Before and after completing the HRVB program (on average 3 weeks).||||score on a scale||Standard Deviation|Mean
2527475|NCT03565874|Secondary|Stress|Perceived stress will be measured on the Perceived Stress Scale-14 (PSS-14). PSS-14 score is calculated on 14 items ranging from 0 to 4. The 7 positive state items (4,5,6,7,9,10 and 13) must have their score reversed (0=4, 1=3, 2=2, 3=1, 4=0) in order to calculate the total score by summing up all 14 items.(Min=0, Max=56). Higher scores indicate a higher level of stress. A validated French version of the PSS will be used.|Before and after completing the HRVB program (on average 3 weeks).||||score on a scale||Standard Deviation|Mean
2527476|NCT03565874|Secondary|HRV: HF|High Frequency (HF) will be used as measures to assess HRV level before and after participation in the HRVB program.|Before and after completing the HRVB program (on average 3 weeks).||||high frequency power normalized unit||Standard Deviation|Mean
2527477|NCT03565874|Secondary|HRV: RMSDD|The root-mean square differences of successive R-R intervals (RMSDD) will be used as measures to assess HRV level before and after participation in the HRVB program.|Before and after completing the HRVB program (on average 3 weeks).||||milliseconds||Standard Deviation|Mean
2527478|NCT03565874|Primary|Satisfaction Regarding the Intervention|"Satisfaction will be measured through a questionnaire. Questions will be asked about global satisfaction, utility, timing and difficulty about their experience (assessed on single item Likert scale).~Higher scores reflects more satisfaction. Possible range 2 to 10."|After completing the HRVB program (on average 3 weeks)||||score on a scale||Standard Deviation|Mean
2527479|NCT03565874|Primary|Feasibility: Number of Sessions Completed During Study|Compliance with study protocol regarding the number of sessions attended by the participants.|After completing the HRVB program (on average 3 weeks)||||sessions completed||Standard Deviation|Mean
2527480|NCT03565874|Primary|Feasibility: Drop-out|The ratio of drop out.|After completing the HRVB program (on average 3 weeks)||||percentage of participants|||Number
2527481|NCT03565874|Primary|Feasibility: Acceptance (Ratio)|The ratio of acceptance of study participation (number of participants who accept to participate to the study / number of participants to whom the study has been proposed) * 100|After completing the HRVB program (on average 3 weeks)|We propose the study to 18 participants and 6 accept to participate. Ratio: (6/18)*100|||percentage of <participants>|||Number
2527482|NCT03565679|Primary|SpO2 Percentage Specification|"Percentage of SpO2 (oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry.~The Accuracy root mean square (ARMS) between measured SpO2 and reference SaO2 (arterial oxygen saturation) must meett the 3% specification for each Medline Renewal Reprocessed pulse oximetry sensor style."|2 hours|Over 70 – 100% an ARMS ≤ 3% in non-motion conditions – Pass result|||Percentage of SpO2|||Number
2527483|NCT03565666|Other Pre-specified|Mean Absolute Relative Difference Between Senseonics Eversense CGM and Contour Next One Glucose Meter|The MARD is calculated as the mean value of individual absolute relative differences (ARD). The ARD is calculated as follows: 100*(CGM-reference glucose)/reference glucose|Days 1-7 of the Adult RCT period||||MARD: Mean of all [(CGMG − PG)/PG]||Standard Deviation|Mean
2527484|NCT03565666|Other Pre-specified|Mean Absolute Relative Difference Between Dexcom G5 CGM and Contour Next One Glucose Meter|The MARD is calculated as the mean value of individual absolute relative differences (ARD). The ARD is calculated as follows: 100*(CGM-reference glucose)/reference glucose|Days 3-7 for the RCT Period||||MARD (CGMG-meter glucose)/meter glucose)||Standard Deviation|Mean
2527485|NCT03565666|Other Pre-specified|Percentage Time in the Glucose Target Range of 70-120mg/dL||Days 3-7 for the RCT Period||||percentage of time||Standard Deviation|Mean
2527486|NCT03565666|Other Pre-specified|Percentage of Time Where Glucose is Greater Than 250 mg/dL||Days 3-7 for the RCT Period||||percentage of time||Standard Deviation|Mean
2527487|NCT03565666|Other Pre-specified|Percentage of Time Where Glucose is Less Than 60 mg/dL||Days 3-7 for the RCT Period||||percentage of time||Standard Deviation|Mean
2527488|NCT03565666|Other Pre-specified|Percentage of Time Where Glucose is Greater Than 180 mg/dL||Days 3-7 for the RCT Period||||percentage of time||Standard Deviation|Mean
2527489|NCT03565666|Other Pre-specified|Percentage of Time in the Glucose Target Range of 70-180 mg/dl||Days 3-7 for the RCT Period||||percentage of time||Standard Deviation|Mean
2527490|NCT03565666|Other Pre-specified|Percentage of Time Where Glucose is Less Than 70 mg/dL||Days 3-7 for the RCT Period||||percentage of time||Inter-Quartile Range|Median
2527491|NCT03565666|Other Pre-specified|Episodes of Diabetic Ketoacidosis (DKA)|pre-specified to report the total number of episodes summed across all participants|Days 3-7 for the RCT Period||||number of episodes|||Number
2527492|NCT03565666|Other Pre-specified|Episodes of Severe Hypoglycemia|Pre-specified to report the total number of episodes summed across all participants|Days 3-7 for the RCT Period||||number of episodes|||Number
2527493|NCT03565666|Primary|Percentage of Time Where Glucose is Less Than 54 mg/dL||Days 3-7 for the RCT Period||||percentage of time||Inter-Quartile Range|Median
2527494|NCT03565666|Primary|Mean CGM Glucose||Days 3-7 for the RCT Period||||mg/dl||Standard Deviation|Mean
2527520|NCT03563313|Secondary|Total Daily Insulin|Total Daily Insulin (units)|26 weeks||||units||Standard Deviation|Mean
2527495|NCT03564444|Secondary|Number of Participants With New Onset Chronic Diseases (NOCDs) Through Day 29 and Day 181|An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant.|Day 1 through Day 29; Day 1 through Day 181|The ITT population included all randomized and treated participants, grouped according to actual treatment.|||Participants|||Count of Participants
2527496|NCT03564444|Secondary|Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) Through Day 29 and Day 181|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.|Day 1 through Day 29; Day 1 through Day 181|The ITT population included all randomized and treated participants, grouped according to actual treatment.|||Participants|||Count of Participants
2527497|NCT03564444|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Day 8 and Day 15|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.|Day 1 through Day 8; Day 1 through Day 15|The ITT population included all randomized and treated participants, grouped according to actual treatment.|||Participants|||Count of Participants
2527498|NCT03564444|Secondary|Number of Participants With Solicited Symptoms Through Day 15|For this study, solicited symptoms included oral fever (> 100 degrees Fahrenheit), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), and headache.|Day 1 through Day 15|The ITT population included all randomized and treated participants, grouped according to actual treatment.|||Participants|||Count of Participants
2527499|NCT03564444|Secondary|Number of Participants With Solicited Symptoms Through Day 8|For this study, solicited symptoms included oral fever (> 100 degrees Fahrenheit), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity (tiredness), and headache.|Day 1 through Day 8|The ITT population included all randomized and treated participants, grouped according to actual treatment.|||Participants|||Count of Participants
2527500|NCT03564444|Primary|Percentage of Participants Reporting Fever (Oral Temperature >= 101 Degrees Fahrenheit) Through Day 8|Percentage of participants with fever (oral temperature >= 101 degrees Fahrenheit) through Day 8 is reported.|Day 1 through Day 8|The ITT population included all randomized and treated participants, grouped according to actual treatment.|||Percentage of participants|||Number
2527501|NCT03563313|Other Pre-specified|Any Adverse Event Rate Per 100 Person-years|For this outcome, the adverse event rate per 100 person-years calculated as a rate.|26 weeks||||events per 100 person-yr|||Number
2527502|NCT03563313|Other Pre-specified|DKA Event Rate Per 100 Person-years|For this outcome, the diabetic ketoacidosis event rate per 100 person-years will be calculated as a rate.|26 weeks||||rate per 100 person-years|||Number
2527503|NCT03563313|Other Pre-specified|Number of Participants With DKA Events|For this outcome, number of participants with diabetic ketoacidosis (DKA) will be tabulated.|26 weeks||||Participants|||Count of Participants
2527504|NCT03563313|Other Pre-specified|SH Event Rate Per 100 Person-years|For this outcome, severe hypoglycemia event rate per 100 person-years will be calculated as a rate.|26 weeks||||rate per 100 person-years|||Number
2527505|NCT03563313|Other Pre-specified|Number of Participants With SH Events|For this outcome, mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group|26 weeks||||Participants|||Count of Participants
2527506|NCT03563313|Other Pre-specified|Unanticipated Adverse Device Effects (UADE)|Unanticipated adverse device effects (UADE)|26 weeks|Study Device|||Unanticipated Adverse Device Effects|||Number
2527507|NCT03563313|Other Pre-specified|Adverse Device Effects (ADE)|Adverse device effects (ADE)|26 weeks||||Participants|||Count of Participants
2527508|NCT03563313|Other Pre-specified|Other Serious Adverse Events (SAE) and Serious Adverse Device Events (SADE)|Other serious adverse events (SAE) and serious adverse device events (SADE)|26 weeks|Other Serious Adverse Events that do not include DKA or Severe Hypoglycemia|||participants|||Number
2527509|NCT03563313|Other Pre-specified|Worsening of HbA1c From Baseline to 26 Weeks by >0.5%|Worsening of HbA1c from baseline to 26 weeks by >0.5%|26 weeks||||Participants|||Count of Participants
2527510|NCT03563313|Other Pre-specified|BG-measured Hyperglycemic Events (One BG Record >350 mg/dL)|BG-measured hyperglycemic events (one BG record >350 mg/dL)|26 weeks||||days|Days||Number
2527511|NCT03563313|Other Pre-specified|BG-measured Hypoglycemic Events (One BG Record <54 mg/dL)|BG-measured hypoglycemic events (one BG record <54 mg/dL)|26 weeks||||days|Days||Number
2527512|NCT03563313|Other Pre-specified|CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL)|CGM-measured hyperglycemic events (>15 minutes with glucose concentration >300 mg/dL)|26 weeks||||events per week||Inter-Quartile Range|Median
2527513|NCT03563313|Other Pre-specified|CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL)|CGM-measured hypoglycemic events (>15 minutes with glucose concentration <54 mg/dL)|26 weeks||||events per week||Inter-Quartile Range|Median
2527514|NCT03563313|Other Pre-specified|Ketone Events Defined as Day With Ketone Level >1.0 mmol/L|Ketone events defined as day with ketone level >1.0 mmol/L|26 weeks||||days|Days||Number
2527515|NCT03563313|Other Pre-specified|Number of Participants With Diabetic Ketoacidosis (Per Protocol)|Diabetic ketoacidosis (per protocol)|26 weeks||||Participants|||Count of Participants
2527516|NCT03563313|Other Pre-specified|Number of Participants With Severe Hypoglycemia (Per Protocol)|Severe hypoglycemia (per protocol)|26 weeks||||Participants|||Count of Participants
2527517|NCT03563313|Secondary|BMI|Body Mass Index (BMI) kg/m^2|26 weeks||||kg/m^2||Standard Deviation|Mean
2527518|NCT03563313|Secondary|Weight|Weight (kg)|26 weeks||||kilograms||Standard Deviation|Mean
2527519|NCT03563313|Secondary|Basal:Bolus Insulin Ratio|Basal:Bolus Insulin Ratio|26 weeks||||ratio||Standard Deviation|Mean
2527521|NCT03563313|Secondary|Technology Acceptance Questionnaire|Technology Acceptance Survey measures the user's perceptions regarding the burdens and the barriers associated with a technology with a higher score indicates increased technology acceptance. There total score uses 37 items with items are rated on a 5 point scale ranging from 1 (strongly disagree) to 5 (strongly agree) for total score range of 37-185.|26 weeks|Administered to CLC arm only. Result from 26-weeks.|||score on a scale||Standard Deviation|Mean
2527522|NCT03563313|Secondary|System Usability Scores (SUS)|System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability|26 weeks|Administered to CLC group only. Results from 26-week.|||score on a scale||Standard Deviation|Mean
2527523|NCT03563313|Secondary|INSPIRE Survey Scores|The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items, the Teens/Adolescents survey has 17 items and the Parent survey has 21 items.|26 weeks|Scores are measured at 26 weeks|||score on a scale||Standard Deviation|Mean
2527524|NCT03563313|Secondary|Clarke Hypoglycemia Awareness Scores|Clarke Hypoglycemia Awareness Scores (0-7 score with higher scores associated with impaired awareness)|26 weeks||||score on a scale||Inter-Quartile Range|Median
2527525|NCT03563313|Secondary|Hypoglycemia Confidence Scale|Hypoglycemia Confidence Scale has 20 items which are rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4.|26 weeks|First two items on hypoglycemia confidence scale|||score on a scale||Full Range|Mean
2527526|NCT03563313|Secondary|Diabetes Distress Scale|Diabetes Distress Scale for adults has 28 items rated on a 6 point Likert scale that ranges from 1 (not a problem) to 6 (a very serious problem). The total score is the mean of the sum of responses and ranges from 1 to 6 where a higher score indicates greater degrees of diabetes distress.|26 weeks|Total Score at 26 weeks|||score on a scale||Standard Deviation|Mean
2527527|NCT03563313|Secondary|Hyperglycemia Avoidance Scale|Hyperglycemia Avoidance Scale total score is the sum of 21 items rated on a 4 point Likert scale from 0 (never) to 4 (almost always) and ranges from 0 to 84 with a higher score indicating greater degrees of avoiding hyperglycemia.|26 weeks|Total Score at 26 weeks|||score on a scale||Standard Deviation|Mean
2527528|NCT03563313|Secondary|HFS-II|For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The survey is scored by summing item responses. Fear of Hypoglycemia Survey (HFS-II) for adults has a total score that is summed from the two subscale scores (33 items) and ranges from 0 to 132 with higher scores indicating greater degrees of fear of hypoglycemia. The teen survey has a total of 25 items and the range of Total scores is 0 to 100. The parent version of the survey has a total of 26 items with Total scores that range from 0 to 108.|26 weeks|Total Score at 26 weeks|||score on a scale||Standard Deviation|Mean
2527529|NCT03563313|Secondary|Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0% or HbA1c <7.0% at 26 Weeks|HbA1c improvement from baseline to 26 weeks >1.0% or HbA1c <7.0% at 26 weeks|26 weeks||||Participants|||Count of Participants
2527530|NCT03563313|Secondary|HbA1c Relative Improvement From Baseline to 26 Weeks >10%|HbA1c relative improvement from baseline to 26 weeks >10%|26 weeks||||percentage||Standard Deviation|Mean
2527531|NCT03563313|Secondary|Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0%|HbA1c improvement from baseline to 26 weeks >1.0%|26 weeks||||Participants|||Count of Participants
2527532|NCT03563313|Secondary|Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >0.5%|HbA1c improvement from baseline to 26 weeks >0.5%|26 weeks||||Participants|||Count of Participants
2527533|NCT03563313|Secondary|Number of Participants With HbA1c <7.5% at 26 Weeks|Number of Participants with HbA1c <7.5% at 26 weeks|26 weeks||||Participants|||Count of Participants
2527534|NCT03563313|Secondary|Number of Participants With HbA1c <7.0% at 26 Weeks|Number of participants HbA1c <7.0% at 26 weeks|26 weeks||||Participants|||Count of Participants
2527535|NCT03563313|Secondary|HBGI|High blood glucose index by CGM with higher values indicating higher risk of hyperglycemia. Index of risk of high blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Kumar A, Gonder-Frederick L, Clarke WL. Algorithmic evaluation of metabolic control and risk of severe hypoglycemia in type 1 and type 2 diabetes using self-monitoring blood glucose data. Diabetes Technol Ther 2003;5:817-828pmid:14633347)|26 weeks||||index||Standard Deviation|Mean
2527536|NCT03563313|Secondary|CGM Time >300|CGM-measured % >300 mg/dL|26 weeks||||percentage||Standard Deviation|Mean
2527537|NCT03563313|Secondary|CGM Time >250|CGM-measured % >250 mg/dL|26 weeks||||percentage||Standard Deviation|Mean
2527538|NCT03563313|Secondary|CGM Hypoglycemia Events|CGM-measured events of at least 15 consecutive minutes <70mg/dL per week|26 weeks||||events per week||Standard Deviation|Mean
2527539|NCT03563313|Secondary|LBGI|Low blood glucose index by CGM with higher index indicating higher risk of hypoglycemia. Values <1 suggest minimal risk. Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. Diabetes Care 21:1870-1875, 1998)|26 weeks||||units on a scale||Standard Deviation|Mean
2527540|NCT03563313|Secondary|CGM Time Below 60|CGM-measured % below 60 mg/dL|26 weeks||||percentage||Standard Deviation|Mean
2527541|NCT03563313|Secondary|Standard Deviation of CGM|CGM measured glucose variability measured with the standard deviation (SD)|26 weeks||||mg/dL||Standard Deviation|Mean
2527542|NCT03563313|Secondary|Coefficient of Variability|CGM measured glucose variability measured with the coefficient of variation (CV)|26 weeks||||percentage SD of Mean||Standard Deviation|Mean
2527543|NCT03563313|Secondary|CGM Time in Range 70-140 mg/dL|CGM-measured % in range 70-140 mg/dL|26 weeks||||percentage||Standard Deviation|Mean
2527544|NCT03563313|Secondary|CGM Time Below 54|CGM-measured % below 54 mg/dL|26 weeks||||percentage||Standard Deviation|Mean
2527550|NCT03563209|Primary|Dynamic Component of Spasticity (Spasticity Angle)|According to the Modified Tardieu Scale, the difference between the angle of slow passive motion and the angle of muscle reaction represents the dynamic component of spasticity (spasticity angle) in degree. A big difference suggests spasticity while the low difference suggests muscular contracture. In this study, dynamic component of spasticity (spasticity angle) at forearm pronation, neutral position and supination was evaluated separately.|1 day (Only one measurement was performed in time (cross-sectional))||||degree||Inter-Quartile Range|Median
2527551|NCT03563183|Secondary|Anti-Varicella Zoster Virus (Anti-VZV) Antibody (Ab) Concentrations, by Frailty Status, in a Subset of Subjects|Anti-VZV Ab concentrations as determined by Enzyme-linked Immunosorbent Assay (ELISA), in a subset of subjects. The assay cut-off is 25 mIU/mL.|Pre-vaccination at Month 0, and post second dose at Months 3, 14, 26 and 38|Analysis was performed on a subset of subjects in Z-064 According to Protocol (ATP) cohort for immunogenicity-humoral (i.e. those among the Z-064 TVC, who met all eligibility criteria, complied with procedures and intervals for analysis,with no elimination criteria during Z-006/022 studies,and for whom data concerning immunogenicity were available)|||mIU/mL||95% Confidence Interval|Geometric Mean
2527552|NCT03563183|Secondary|Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations, by Frailty Status, in a Subset of Subjects|Anti-gE Ab concentrations as determined by Enzyme-linked Immunosorbent Assay (ELISA), in a subset of subjects. The assay cut-off is 97 milli-international units (mIU)/mL.|Pre-vaccination at Month 0, and post second dose at Months 3, 14, 26 and 38|Analysis was performed on a subset of subjects in Z-064 According to Protocol (ATP) cohort for immunogenicity-humoral (i.e. those among the Z-064 TVC, who met all eligibility criteria, complied with procedures and intervals for analysis,with no elimination criteria during Z-006/022 studies,and for whom data concerning immunogenicity were available)|||mIU/mL||95% Confidence Interval|Geometric Mean
2527553|NCT03563183|Secondary|Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs), by Frailty Status|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related = pIMDs assessed by the investigator as related to the vaccination.|During the entire study period (3 to 5 year period following Day 0)|Analysis was performed on all subjects included in the Zoster-064 TVC. Note that due to the retrospective observational nature of this study, new safety data was not collected in Zoster-064; the safety data presented here was originally collected as part of the Zoster-006 and Zoster-022 studies.|||Participants|||Count of Participants
2527554|NCT03563183|Secondary|Number of Subjects With Any Fatal Serious Adverse Events (SAEs), by Frailty Status|Serious adverse events (SAEs) assessed include medical occurrences that result in death.|During the entire study period (3 to 5 year period following Day 0)|Analysis was performed on all subjects included in the Zoster-064 TVC. Note that due to the retrospective observational nature of this study, new safety data was not collected in Zoster-064; the safety data presented here was originally collected as part of the Zoster-006 and Zoster-022 studies.|||Participants|||Count of Participants
2527555|NCT03563183|Secondary|Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine, by Frailty Status|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAEs throughout the entire study period by frailty status were reported for SAEs considered related to study participation or to a concurrent GSK medication/vaccine.|During the entire study period (3 to 5 year period following Day 0)|Analysis was performed on all subjects included in the Zoster-064 TVC. Note that due to the retrospective observational nature of this study, new safety data was not collected in Zoster-064; the safety data presented here was originally collected as part of the Zoster-006 and Zoster-022 studies.|||Participants|||Count of Participants
2527556|NCT03563183|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs), by Frailty Status|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAEs were those considered vaccine-related by the investigator.|From Month 0 to Month 14|Analysis was performed on all subjects included in the Zoster-064 TVC. Note that due to the retrospective observational nature of this study, new safety data was not collected in Zoster-064; the safety data presented here was originally collected as part of the Zoster-006 and Zoster-022 studies.|||Participants|||Count of Participants
2527557|NCT03563183|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs), by Frailty Status|An unsolicited AE covered any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0 - 29) after each vaccination|Analysis was performed on all subjects included in the Zoster-064 TVC. Note that due to the retrospective observational nature of this study, new safety data was not collected in Zoster-064; the safety data presented here was originally collected as part of the Zoster-006 and Zoster-022 studies.|||Participants|||Count of Participants
2527558|NCT03563183|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Frailty Status|Assessed solicited general symptoms were, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and gastro-intestinal (GI) symptoms(nausea, vomiting, diarrhoea and/or abdominal pain) Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0-6) after each vaccination|Analysis was performed on all subjects in the Zoster-064 TVC diary card subset for analysis of reactogenicity. Note that due to the retrospective observational nature of this study, new safety data was not collected in Zoster-064; the safety data presented here was originally collected as part of the Zoster-006 and Zoster-022 studies.|||Participants|||Count of Participants
2527982|NCT03535844|Primary|Change in Lipidomic Profiles|The main classes of lipids in the cell membrane|Pre- and post-intervention (Week 16)||2020-09-30|09/2020||||
2527559|NCT03563183|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Frailty Status|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within 7 days (Days 0-6) after each vaccination|Analysis was performed on all subjects in the Zoster-064 TVC diary card subset for analysis of reactogenicity. Note that due to the retrospective observational nature of this study, new safety data was not collected in Zoster-064; the safety data presented here was originally collected as part of the Zoster-006 and Zoster-022 studies.|||Participants|||Count of Participants
2527560|NCT03563183|Secondary|Herpes Zoster Burden of Illness Score, by Frailty Status|"Zoster Brief Pain Inventory (ZBPI) Burden of Illness (BOI) score was calculated as the sum of the ZBPI worst pain scores for all subjects in the group divided by the total follow-up time (Person-years). HZ Burden of Illness score for subjects was calculated from the Zoster Brief Pain Inventory (ZBPI), for each confirmed HZ cases responding to the worst pain question in both ZOSTER-006 and ZOSTER-022, and defined as the area under the curve of confirmed HZ-associated pain plotted against time during the 182-day period after the onset of the case. Subjects who developed HZ presented burden-of-illness scores ranging from 0 up to, theoretically, 1820. A score of 0 is recorded for subjects in whom HZ did not develop during the study period. Subjects who had a confirmed Zoster episode but who did not have at least 1 ZBPI assessment were excluded from the analysis."|During the entire study period (3 to 5 year period following Day 0)|Analysis was performed on all subjects in the Modified Total Vaccinated Cohort (mTVC) of ZOSTER-064. The Z-064 mTVC excluded subjects in the Z-064 TVC who were not administered the second vaccination or who developed a confirmed case of Herpes Zoster (HZ) prior to 1 month after the second vaccination.|||Score per subject-year|||Number
2527561|NCT03563183|Secondary|Incidence Rate (Per 1000 Person-years) of Confirmed Herpes Zoster (HZ) Cases, by Frailty Status|Incidence rate (IR) of confirmed Herpes zoster (HZ) cases with 95% Confidence Interval (CI) calculated as the number of cases per 1000 person-years : numerator = number of confirmed HZ cases reported during the follow-up (FU) period at risk; denominator = total Person-years at risk, i.e. sum of FU periods at risk expressed in years until first confirmed HZ cases or occurrence of treatment for relapse. A suspected HZ case defined as (1) new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations), or vesicular rash suggestive of Varicella Zoster Virus (VZV) infection regardless of the distribution, and no alternative diagnosis; or (2) clinical presentation and specific laboratory findings suggestive of VZV infection in the absence of HZ or VZV rash. A suspected case of HZ was confirmed either by PCR or by the HZ Ascertainment Committee (HZAC), consisting of physicians with HZ expertise.|During the entire study period (3 to 5 year period following Day 0)|Analysis was performed on all subjects in the Modified Total Vaccinated Cohort (mTVC) of ZOSTER-064. The Z-064 mTVC excluded subjects in the Z-064 TVC who were not administered the second vaccination or who developed a confirmed case of Herpes Zoster (HZ) prior to 1 month after the second vaccination.|||Cases per 1000 person-year|||Number
2527562|NCT03563183|Primary|Number of Subjects by Frailty Status, at Baseline|"Frailty status was measured in relation to the accumulation of deficits using a Frailty Index (FI) adapted from the model proposed by Mitnitski et al. [Mitnitski, 2001]. The different aspects of frailty composing the FI were assessed through the medical history and components of the Short Form 36 Questionnaire (SF-36) and EuroQol (EQ)-5D questionnaires recorded pre-vaccination Dose 1 (in the study ZOSTER-006[NCT01165177] and ZOSTER-022[NCT01165229]).~If the FI was less than or equal to 0.08, the subject was classified as Non-Frail. If the score was greater than 0.08 but less than or equal to 0.25, the subject was classified as pre-frail. If the score was greater than 0.25, the subject was classified as Frail. Subjects without a FI score were classified as unknown."|At Baseline (Month 0)|Analysis was performed on all subjects included in the Total Vaccinated Cohort (TVC) of Zoster-064|||Participants|||Count of Participants
2527563|NCT03563183|Secondary|Distribution of EuroQol (EQ)-5D Questionnaire Scale Scores, by Country|"The EQ-5D questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 possible responses (No symptoms, Moderate symptoms, Extreme symptoms). The 5 items are then combined to generate health profiles that are subsequently converted to a continuous single index utility score using a one to one matching. Country or region-specific value sets are used for the score conversion. The scores range from less than 0 (where 0 is the value of a health state equivalent to dead) to 1 (the value of full health), with higher scores indicating higher health utility.~The EQ-5D also contains a visual analogue scale (VAS). The VAS records the respondent's self-rated health on a vertical scale, ranging from 0(worst imaginable health state) to 100(best imaginable health state)."|At Month 0, 14, 26 and 38|Analysis was performed on all subjects included in the Total Vaccinated Cohort (TVC) of Zoster-064|||Scale score||Standard Deviation|Mean
2527564|NCT03563183|Secondary|Distribution of Short Form 36 (SF-36) Questionnaire Scale Scores, by Country|"The mean and standard deviation of the SF-36 Questionnaire scale scores are presented for each time point. The SF-36 is a multi-purpose health survey with 36 questions underlying the construction of 8 scales [Ware, 2001]: Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE) and Mental Health (MH).~All but one of the 36 items (self-reported health transition) are used to score the eight SF-36 scales. Each item is used in scoring only one scale. Scale scores are constructed following the summated ratings and standardized SF-36 scoring algorithms. The SF-36 scores range from 0 to 100, with high scores indicating high levels of functioning/quality of life."|At Month 0, 14, 26 and 38|Analysis was performed on all subjects included in the Total Vaccinated Cohort (TVC) of Zoster-064|||Scale score||Standard Deviation|Mean
2527565|NCT03562559|Primary|Skin to Adductor Canal Distance Disparity|The largest distance disparity as measured from the 5 different leg positions|Measurements will be made on the day of surgery, no other assessment or follow up needed||||centimeters||90% Confidence Interval|Mean
2527566|NCT03562117|Secondary|AUC(0-48) of Gepotidacin|Urine samples were collected from participants at indicated time points to evaluate AUC(0-48) PK parameter of gepotidacin.|Pre-dose, 0-2 hours, 2-4 hours, 4-6 hours, 6-8 hours, 8-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post dose|PK Parameter Population. Only those participants with data available at the specified data points were analyzed.|||Hours*micrograms per milliliter||Standard Deviation|Mean
2527567|NCT03562117|Secondary|AUC(0-24) of Gepotidacin|Urine samples were collected from participants at indicated time points to evaluate AUC(0-24) PK parameter of gepotidacin.|Pre-dose, 0-2 hours, 2-4 hours, 4-6 hours, 6-8 hours, 8-12 hours and 12-24 hours post dose|PK Parameter Population. Only those participants with data available at the specified data points were analyzed.|||Hours*micrograms per milliliter||Standard Deviation|Mean
2527568|NCT03562117|Secondary|AUC(0-12) of Gepotidacin|Urine samples were collected from participants at indicated time points to evaluate AUC(0-12) PK parameter of gepotidacin.|Pre-dose, 0-2 hours, 2-4 hours, 4-6 hours, 6-8 hours and 8-12 hours post dose|PK Parameter Population. Only those participants with data available at the specified data points were analyzed.|||Hours*micrograms per milliliter||Standard Deviation|Mean
2527569|NCT03562117|Secondary|Renal Clearance (CLr) of Gepotidacin|Urine samples were collected from participants at indicated time points. Renal clearance for gepotidacin was calculated as Ae_total divided by AUC (0-t).|Pre-dose, 0-2 hours, 2-4 hours, 4-6 hours, 6-8 hours, 8-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-dose|PK Parameter Population. Only those participants with data available at the specified data points were analyzed.|||Liters per hour||Standard Deviation|Mean
2527570|NCT03562117|Secondary|Percentage of the Given Dose of Drug Excreted in Urine (Fe%)|Urine samples were collected from participants at indicated time points. Percentage of the given dose of drug excreted in urine was calculated as: (Ae_total divided by Dose) and multiplied by 100.|Pre-dose, 0-2 hours, 2-4 hours, 4-6 hours, 6-8 hours, 8-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-dose|PK Parameter Population. Only those participants with data available at the specified data points were analyzed.|||Percentage of drug||Standard Deviation|Mean
2527571|NCT03562117|Secondary|Total Unchanged Drug (Ae_total) and Amount of Drug Excreted in Urine in a Time Intervals (Ae (t1-t2) for Gepotidacin|Urine samples were collected from participants at indicated time points. Ae_total was calculated by adding all the fractions of drug collected over all the allotted time intervals. Ae (t1-t2) was the amount of drug excreted in urine in time intervals for predose, 0 to 6, 6 to 12, 12 to 24, 24 to 36, and 36 to 48 hours after dosing for participants with hepatic impairment; and predose, 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours for participants with normal hepatic function. It was calculated by multiplication of the urine concentration for a time interval and the length of this time interval.|Pre-dose, 0-2 hours, 2-4 hours, 4-6 hours, 6-8 hours, 8-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-dose|PK Parameter Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Milligrams||Standard Deviation|Mean
2527572|NCT03562117|Secondary|Number of Participants With Abnormal Findings During Physical Examinations|A complete physical examination included, at a minimum, assessments of the skin, cardiovascular, respiratory, gastrointestinal and neurological systems. Height and weight were also measured and recorded. A brief physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). This analysis was planned but data was not captured in the database. Abnormal changes were captured as adverse events if they were clinically significant.|Pre-dose up to 31 days prior to dosing|Safety Population. This analysis was planned but data was not captured in the database.||||||
2527573|NCT03562117|Secondary|Number of Participants With Toxicity Grading 3 or Higher for Urinalysis Parameters|Urine samples were collected and specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones were analyzed by dipstick method.|Up to 15 days|Safety Population.|||Participants|||Count of Participants
2527574|NCT03562117|Secondary|Number of Participants With Toxicity Grading 3 or Higher for Hematology Parameters|Blood samples were collected to measure the number of participants with toxicity grades higher than 3 or 4 for blood neurtophils and blood platelets.|Up to 15 days|Safety Population.|||Participants|||Count of Participants
2527575|NCT03562117|Secondary|Change From Baseline Values for Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Urea|Blood samples were collected to analyze clinical chemistry parameters including calcium, glucose, potassium, sodium and urea. Baseline is defined as Day 1 (Pre-Dose). Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline and at Day 2|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Millimoles per liter||Standard Deviation|Mean
2527576|NCT03562117|Secondary|Change From Baseline Values for Clinical Chemistry Parameters: Bilirubin, Direct Bilirubin and Creatinine|Blood samples were collected to analyze clinical chemistry parameters including bilirubin, direct bilirubin and creatinine. Baseline is defined as Day 1 (Pre-Dose). Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline and at Day 2|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Micromoles per liter||Standard Deviation|Mean
2527577|NCT03562117|Secondary|Change From Baseline Values for Clinical Chemistry Parameters: Albumin and Protein|Blood samples were collected to analyze clinical chemistry parameters including albumin and protein. Baseline is defined as Day 1 (Pre-Dose). Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline and at Day 2|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Grams per liter||Standard Deviation|Mean
2527578|NCT03562117|Secondary|Change From Baseline Values for Clinical Chemistry Parameters: ALT, ALP, AST and CK|Blood samples were collected to analyze clinical chemistry parameters including: ALT, ALP, AST and CK. Baseline is defined as Day 1 (Pre-Dose). Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline and at Day 2|Safety Population. Only those participants with data available at the specified data points were analyzed.|||International units per liter||Standard Deviation|Mean
2527579|NCT03562117|Secondary|Number of Participants With Toxicity Grading 3 or Higher for Clinical Chemistry Parameters|Blood samples were collected to measure the number of participants with toxicity grades higher than 3 or 4, for urea, Creatine kinase (CK), creatinine, glucose, sodium, potassium, calcium, Aspartate Aminotransferase, (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) levels, total and direct bilirubin, total protein, and albumin.|Up to Day 15|Safety Population.|||Participants|||Count of Participants
2528002|NCT03535571|Secondary|Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-6 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).|Measured by the Multi-Analyte ELISArray|Baseline (Day 0) to end-of-study (Day 128)|Intent to treat population|||pg/mL||Standard Deviation|Mean
2527580|NCT03562117|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment.|Up to Day 15|Safety Population.|||Participants|||Count of Participants
2527581|NCT03562117|Secondary|Change From Baseline Values in Heart Rate|Vital signs was measured in a semi-supine position after 5 minutes rest. Baseline is defined as Day 1 (Pre-Dose). Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at 1.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post dose|Safety Population.|||Beats per minute||Standard Deviation|Mean
2527582|NCT03562117|Secondary|Change From Baseline Values in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital signs were measured in a semi-supine position after 5 minutes rest. Baseline is defined as Day 1 (Pre-Dose). Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at 1.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post-dose|Safety Population.|||Millimeters of mercury||Standard Deviation|Mean
2527583|NCT03562117|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Single 12-lead ECG was obtained in a semi-supine position after 5 minutes rest using an ECG machine. Safety Population consists of all participants who received at least 1 dose of study drug and had at least one postdose safety assessment. Number of participants with abnormal-clinically significant and abnormal-not clinically significant values has been presented. Absolute QTc Interval >450 milliseconds (msec), absolute PR interval <110 msec and absolute QRS interval <75 msec was considered as clinically significant ECG findings.|1.5 hours, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, and 48 hours post-dose|Safety Population.|||Participants|||Count of Participants
2527584|NCT03562117|Secondary|Terminal Phase Half Life (t1/2) for Plasma Gepotidacin|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose|PK Parameter Population.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2527585|NCT03562117|Secondary|Terminal-phase Rate Constant (Lambda_z) for Plasma Gepotidacin|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose|PK Parameter Population.|||Per hour||Geometric Coefficient of Variation|Geometric Mean
2527586|NCT03562117|Secondary|Apparent Volume of Distribution of the Terminal Phase (Vz/F) for Plasma Gepotidacin|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose|PK Parameter Population.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2527587|NCT03562117|Secondary|Apparent Oral Clearance (CL/F) for Plasma Gepotidacin|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose|PK Parameter Population.|||Liters per hours||Geometric Coefficient of Variation|Geometric Mean
2527588|NCT03562117|Secondary|Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) for Plasma Gepotidacin|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose|PK Parameter Population.|||Hours||Full Range|Median
2527589|NCT03562117|Secondary|Time to First Occurrence (Tmax) of Cmax for Plasma Gepotidacin|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose|PK Parameter Population.|||Hours||Full Range|Median
2527590|NCT03562117|Secondary|AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUC [0-t]) for Plasma Gepotidacin|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose|PK Parameter Population.|||Hours*nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2527591|NCT03562117|Primary|Maximum Observed Concentration (Cmax) for Plasma Gepotidacin|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose|PK Parameter Population.|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2527592|NCT03562117|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinity (AUC[0-inf]) for Plasma Gepotidacin|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters. PK parameter population consist of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. This population was used in the assessment and characterization of PK parameters.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose|PK Parameter Population.|||Hours*nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2527593|NCT03560128|Secondary|Detection of Serrated Lesions|"Comparison of the number of participants with at least one Sessile Serrated Polyp detected (SSPDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.~Comparison of the number of participants with at least one flat polyp detected between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy."|During colonoscopy procedure||||Participants|||Count of Participants
2527594|NCT03560128|Secondary|Cecal Intubation Rate|Comparison of the number of procedures where the colonoscope was able to reach the cecum between AmplifEYE colonoscopy and Endocuff Vision colonoscopy.|During Colonoscopy procedure||||Participants|||Count of Participants
2528465|NCT03508050|Secondary|Complete Lung Collapse (CLC-clinical)|The time required to obtain CLC. This end-point is assessed clinically by the surgeon during the surgery|From the beginning of surgery (pleural opening) until 60 minutes||||minutes||Standard Deviation|Mean
2527595|NCT03560128|Secondary|Time Comparison for Each Method|"Comparison of the insertion time, overall withdrawal time, inspection time, and total procedure time between the AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.~Insertion time: time it takes from the colonoscope first being inserted to when the cecum is reached Withdrawal time: time calculated from when withdrawing is started in the cecum until the colonoscope is removed. This includes time spent washing, suctioning, inspecting the colon, and removing polyps.~Inspection time: time spent actually examining the colon and does not include time spent for washing the colon, suctioning, and removing polyps.~Total procedure time: time from the initial insertion of the colonoscope through the complete withdrawal of the colonoscope."|During colonoscopy procedure||||Minutes||Standard Deviation|Mean
2527596|NCT03560128|Secondary|Polyps Per Colonoscopy (PPC)|Comparison of the number of polyps detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.|During colonoscopy procedure||||Polyps||Standard Deviation|Mean
2527597|NCT03560128|Secondary|Passage of Device Through Sigmoid Colon|Comparison of the number of times the device had to be removed to pass the sigmoid colon between colonoscopies with the AmplifEYE device and colonoscopies with the Endocuff Vision device.|during insertion portion of colonoscopy||||Participants|||Count of Participants
2527598|NCT03560128|Secondary|Complications Encountered During Procedure|Comparison of amount of mucosal trauma (such as scratches), perforation (making a hole in the colon wall), or gastrointestinal bleeding between patients that have AmplifEYE colonoscopy compared to patients that have Endocuff Vision colonoscopy.|During Colonoscopy procedure||||Participants|||Count of Participants
2527599|NCT03560128|Secondary|Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR))|"Comparison of the number of participants with at least one adenoma detected (ADR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.~Comparison of the number of participants with at least one polyp detected (PDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy."|During colonoscopy procedure||||Participants|||Count of Participants
2527600|NCT03560128|Primary|Number of Adenomas Detected Per Colonoscopy (APC).|Comparison of the number of adenomas detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.|During colonoscopy procedure||||adenomas||Standard Deviation|Mean
2527601|NCT03559829|Secondary|Patient Experience|Patient self-reported satisfaction with device use (5-point Likert Scale, with higher scores indicating greater satisfaction).|8 weeks||||score on a scale||Standard Deviation|Mean
2527602|NCT03559829|Secondary|Stroke Impact Scale (SIS)|Score on the SIS at 8-weeks. The score ranges from 0 to 100, with higher scores corresponding to better recovery from stroke.|8 weeks||||score on a scale||Standard Deviation|Mean
2527603|NCT03559829|Secondary|Manual Muscle Testing (MMT) Score|The MMT score is the sum of the Medical Research Council (MRC) scores across 5 domains (elbow flexor, elbow extensor, wrist extension, finger extension and finger flexion) at 8 weeks. Each domain has a scale range of 0 to 5, with higher scores corresponding to better strength. Maximum MMT score ranges from 0-25, with higher scores corresponding to better strength.|8 weeks||||score on a scale||Standard Deviation|Mean
2527604|NCT03559829|Secondary|Fugl-Meyer Assessment|Upper Extremity Fugl-Meyer Test score at 8-weeks. Score ranges from 0 to 66, with higher scores corresponding to better arm function.|8 weeks||||score on a scale||Standard Deviation|Mean
2527605|NCT03559829|Secondary|Jebsen-Taylor Hand Function Test - Gross Score|Time (in seconds) to complete the three gross-motor subtests of the Jebsen-Taylor Hand Function Test administered at 8-weeks. Each of the three gross-motor subtests is allotted a maximum time of 90 seconds. The total gross-motor score is the sum of the scores of the three subtests. The total score has a maximum of 270 seconds and there is no minimum. Longer time to complete the test indicates worse hand function.|8 weeks||||seconds||Standard Deviation|Mean
2527606|NCT03559829|Secondary|Jebsen-Taylor Hand Function Test - Fine Score|Time (in seconds) to complete the four fine-motor subtests of the Jebsen-Taylor Hand Function Test administered at 8-weeks. Each of the four subtests is allotted a maximum time of 90 seconds. The total score is the sum of the scores of the four subtests. The total score has a maximum of 360 seconds and there is no minimum. Longer time to complete the test indicates worse hand function.|8 weeks||||seconds||Standard Deviation|Mean
2527607|NCT03559829|Secondary|Jebsen-Taylor Hand Function Test - Overall Score|Time (in seconds) to complete the total Jebsen-Taylor Hand Function Test administered at 8-weeks. The test consists of 7 subtests. Each subtest is allotted a maximum time of 90 seconds. The total score is the sum of the scores of the seven subtests. The total score has a maximum of 630 seconds and there is no minimum. Longer time to complete the test indicates worse hand function.|8 weeks||||seconds||Standard Deviation|Mean
2527608|NCT03559829|Secondary|Device Use Daily Average|Daily average number of minutes of device-use during 8-week intervention period.|8 weeks||||minutes||Standard Deviation|Mean
2527609|NCT03559829|Secondary|Device Use Daily Average Per Use Day|Daily average number of minutes of device-use per days that device was used.|8 weeks||||minutes||Standard Deviation|Mean
2527610|NCT03559829|Primary|Device Use|Number of days during 8 week study-period that patient used the device.|8 weeks||||days||Standard Deviation|Mean
2527611|NCT03559179|Secondary|Compare Post-intervention Referral Patterns Between Intervention and Control Groups|Calculate and compare how often patients diagnosed with OUD are referred to specialty care or inpatient treatment post-intervention. Compare these rates between intervention and control groups.|This was calculated at the end of the pilot study (month 8).||||post/pre ratio of referral per pt. year|||Number
2527612|NCT03559179|Secondary|Compare Pre- and Post-intervention Rates of Medication-assisted Therapy (MAT) Use.|Calculate and compare the rate of MAT use among patients with OUD pre- and post-intervention. This is presented as a pre/post ratio of MAT rx per patient year.|This was calculated at the end of the pilot study (month 8).||||pre/post ratio MAT Rx per patient year|||Number
2527613|NCT03559179|Secondary|Compare Pre- and Post-intervention Rates of OUD Diagnosis in High-risk Patients.|Calculate and compare the number of patients diagnosed with OUD pre- and post-intervention. This will be presented as rate of OUD diagnoses per patient year.|This was calculated at the end of the pilot study (month 8).||||OUD diagnosis per patient year|||Number
2528003|NCT03535571|Secondary|Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-4 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).|Measured by the Multi-Analyte ELISArray|Baseline (Day 0) to end-of-study (Day 128)|Intent to treat population|||pg/mL||Standard Deviation|Mean
2527614|NCT03559179|Primary|Intervention PCP Likeliness to Recommend Use of the OUD-CDS|"# of PCPs with CDS access who rate the OUD-CDS >4 on a 5-point Likert scale of likeliness to recommend use of the tool to their colleagues. The scale ranges from 1-not at all likely to 5-very likely, with higher values representing a higher likelihood of recommending the OUD-CDS to other colleagues."|This was calculated after PCP surveys were completed, approximately month 10|One non-waivered intervention provider stopped working for the organization and two additional non-waivered intervention providers did not complete the follow-up survey.|||Participants|||Count of Participants
2527615|NCT03559179|Primary|Intervention PCP Confidence in Assessing and Treating OUD|"# of intervention PCPs who report feeling moderately or very confident in assessing and treating OUD."|This outcome measure was calculated at approximately month 10 of the pilot study|"This outcome was to help show proof of the OUD-CDS concept using responses from intervention PCPs. One intervention provider stopped working for the organization during the intervention. Two additional intervention providers in the Non-Waivered providers who received the Opioid Wizard arm did not complete follow-up surveys."|||Participants|||Count of Participants
2527616|NCT03559062|Secondary|Safety and Tolerability as Assessed Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Safety Follow-up Visit||From first dose of study drug up to safety follow-up visit (up to Week 12)|Safety set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2527617|NCT03559062|Secondary|Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 8|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|From baseline through Week 8|FAS. As per the pre-specified analysis, efficacy was only planned to be assessed for TEZ/IVA group. Placebo or IVA groups were used for blinding purposes only and were not applicable for the purpose of secondary efficacy analysis.|||units on a scale||Standard Error|Least Squares Mean
2527618|NCT03559062|Secondary|Absolute Change in Sweat Chloride At Week 8|Sweat samples were collected using an approved collection device.|From baseline at Week 8|FAS. As per the pre-specified analysis, efficacy was only planned to be assessed for TEZ/IVA group. Placebo or IVA groups were used for blinding purposes only and were not applicable for the purpose of secondary efficacy analysis.|||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
2527619|NCT03559062|Primary|Absolute Change in Lung Clearance Index 2.5 (LCI2.5) Through Week 8|LCI2.5 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting value.|From baseline through Week 8|Full Analysis Set: all participants who were randomized, received at least 1 dose of study drug and had an eligible genotype. As per the pre-specified analysis, efficacy was only planned to be assessed for TEZ/IVA group. Placebo or IVA groups were used for blinding purposes only and were not applicable for the purpose of primary efficacy analysis.|||lung clearance index||Standard Error|Least Squares Mean
2527620|NCT03558555|Secondary|Patient Satisfaction.|Patient satisfaction total scale from 1 to 10, with higher score indicating more satisfaction|7 days post surgery|one missing survey|||score on a scale||Standard Deviation|Mean
2527621|NCT03558555|Secondary|Patient Reported Total Narcotic Use Post-discharge|home opiod use|average 7 days||||MME||Standard Deviation|Mean
2527622|NCT03558555|Secondary|PACU Length of Stay|Time in PACU|up to 24 hours after PACU arrival||||minutes||Standard Deviation|Mean
2527623|NCT03558555|Primary|Total Narcotic Use in PACU.|Total narcotic use in PACU expressed in total morphine milligram equivalents (MME)|Day 1||||MME||Standard Deviation|Mean
2527624|NCT03558555|Primary|Total MME Intraoperatively|Total Morphine Milligram Equivalent (MME) use intraoperatively|Day 1||||MME||Standard Deviation|Mean
2527625|NCT03558555|Primary|PACU Visual Analogue Pain Scores|Post-Anesthesia Care Unity (PACU) pain scores at baseline, 1 hour, and on discharge from PACU. Pain score by visual analogue score, total scale from 0 to 10 with 10 being the worse pain.|baseline, 1 hour, and Day 1 discharge||||score on a scale||Standard Deviation|Mean
2527626|NCT03558230|Primary|Feasibility (Total Number of Hours That Participants Wear the Device)|total number of hours that participants wear the device|through 5-day study completion.||||Hours||Standard Deviation|Mean
2527627|NCT03557801|Secondary|Patient Reported Measures From the Satisfaction With Cancer Related Care Scale.|Satisfaction with care will be measured with the Patient Satisfaction with Cancer-Related Care (PSCC) Measure. This is an 18 question measure. The questions are scored on a scale from 1-5. The total score will range 5-90, higher scores indicate higher satisfaction with care.|Approximately 2 weeks after consent/screening mammogram.|Participants that completed the study.|||score on a scale||Standard Deviation|Mean
2527628|NCT03557801|Secondary|Patient Reported Measures From the Distrust in the Healthcare System Scale. Reported at Baseline and Post Intervention. Also Reported as the Change Between Baseline and Intervention.|Distrust will be measured with the Revised Healthcare System Distrust Scale. This 9 question scale is divided into two subscales: competence and values. The questions are scored on a scale from 1-5. The total score will range 5-45, with higher scores indicating higher levels of trust. Baseline distrust measured at time of initial consent/screening. Post-intervention distrust measured at time of post-survey which took place approximately 2 weeks after screening (varied as to when patient could be reached for survey). Difference in distrust is subtracts the baseline score from the post score.|Baseline, approximately 2 weeks after consent/screening mammogram.||||score on a scale||Standard Deviation|Mean
2527629|NCT03557801|Primary|Patient Reported Measures From Interpersonal Processes of Care Survey|Selected scales (communication and interpersonal style) of the Interpersonal Processes of Care Survey will be the primary outcome. A total of 18 (corrected from orginal submission) questions will be administered. The questions are scored on a scale from 1-5 with higher scores indicating higher frequencies of the construct. The compiled scores will range from 5-90. Scales with negative associations (discrimination, hurried communication) will be reversed. Thus, higher scores for all items will indicate a more positive experience.|Approximately 2 weeks after consent/screening mammogram.|Participants that completed the study.|||score on a scale||Inter-Quartile Range|Median
2527630|NCT03557476|Secondary|Glutathione Peroxidase|Plasma levels of glutathione peroxidase|6 days||||U/gHb||Standard Deviation|Mean
2527631|NCT03557476|Secondary|Superoxide Dismutase|Plasma levels of superoxide dismutase|6 days||||U/gHb||Standard Deviation|Mean
2527637|NCT03556579|Primary|Starburts|The appearance of starbursts was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Starbursts are defined as the diameter (mm) of the light's lateral spread. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups.|Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2|Subjects that have completed all study visits without a major protocol deviation impacting a primary endpoint.|||mm|eyes|Standard Deviation|Mean
2527638|NCT03556579|Secondary|Heterochromatic Contrast Threshold|Heterochromatic Contrast Threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Heterochromatic contrast thresholds are measured as thresholds to a variable wavelength central target presented on a short-wave (460nm) sky-light background. Thresholds are positive values, where higher values indicate better lens performance. The average threshold each lens type was reported across age groups.|Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1|Subjects that completed all study visits without a major protocol deviation impacting a primary endpoint.|||log units|eyes|Standard Deviation|Mean
2527639|NCT03556579|Secondary|Glare Discomfort|The Glare discomfort (change in palpebral fissure height) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Glare discomfort can take on negative and positive values, where smaller values indicate better lens performance. The average glare discomfort (change in palpebral fissure height) for each lens type was reported across age groups.|Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1|Subjects that completed all study visits wihtout a major protocol deviation impacting a primary endpoint.|||mm|eyes|Standard Deviation|Mean
2527640|NCT03556579|Secondary|Photostress Recovery Time|Photostress Recovery (PR) Time (seconds) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects are exposed to a target, once the target was able to be comfortable viewed by the subject, a bright bleaching light covered it. As the afterimage fades, participants will gradually be able to re-gain sight of the target. PR time will be recorded as the time it takes following exposure to the bleaching light to regain sight of the target. PR Times are positive values where smaller times indicate better lens performance. The average PR Time (seconds) for each lens type was reported across age groups.|Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1|Subjects that completed all study visits without a major protocol deviation impacting a primary endpoint.|||seconds|eyes|Standard Deviation|Mean
2527641|NCT03556579|Secondary|Glare Disability Threshold|The Glare disability threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects were exposed to a target stimulus for 2 seconds; before the measurement was taken the annulus was set to a level below that which would cause the target stimulus to be veiled. The experimenter would then adjust the intensity of the annulus until subjects could no longer see the target stimulus. Subjects would indicate this by pressing a buzzer. Glare disability thresholds take on positive values, where higher values indicate better lens performance. The average glare disability level (change in log relative energy) for each lens type was reported across age groups.|Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1|All subjects that completed the study without a major protocol deviation impacting any primary endpoint.|||log units|eyes|Standard Deviation|Mean
2527642|NCT03556579|Primary|Halos|The appearance of Halos was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Halos were quantified as the diameter (mm) of the outer edges of the Halo. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups.|Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2|All subjects that completed the study without a major protocol deviation impacting any primary endpoint.|||mm|Eyes|Standard Deviation|Mean
2527643|NCT03556579|Primary|Two-Point Light Spread Function|The two-point light spread function was assessed at visit 2 for each subject eye under two conditions with a distance filter and without a distance filter. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Two-point light spread function is defined that the as the minimum distance (mm) that two points of light are completely distinct. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type and light source combination was reported across age groups.|Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2|All subjects that completed the study without a major protocol deviation impacting any primary endpoint.|||mm|Eyes|Standard Deviation|Mean
2527644|NCT03555890|Secondary|Part 2: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval|Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Millisecond||Standard Deviation|Mean
2527645|NCT03555890|Secondary|Part 1: Change From Baseline in PR Interval, QRS Interval, QT Interval and QTcF Interval|Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in PR interval, QRS interval, QT interval and QTcF interval was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose|Safety Population.|||Millisecond||Standard Deviation|Mean
2527705|NCT03555890|Primary|Part 1: Maximum Observed Concentration (Cmax) of Levocetirizine|Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data.|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose|PK Population|||Nanogram per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
2527646|NCT03555890|Secondary|Part 2: Change From Baseline in Heart Rate (ECG)|Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF. Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Beats per minute||Standard Deviation|Mean
2527647|NCT03555890|Secondary|Part 1: Change From Baseline in Heart Rate (12-Lead Electrocardiogram [ECG])|Single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval with Fridericia's correction (QTcF). Change from Baseline in heart rate (ECG) was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 1, 48 hours post-dose|Safety Population.|||Beats per minute||Standard Deviation|Mean
2527648|NCT03555890|Secondary|Part 2: Change From Baseline in Body Temperature|Body temperature was measured in supine position after 5 minutes rest. Change from Baseline in body temperature was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Degree Celsius||Standard Deviation|Mean
2527649|NCT03555890|Secondary|Part 1: Change From Baseline in Body Temperature|Body temperature was measured in supine position after 5 minutes rest. Change from Baseline in body temperature was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose|Safety Population.|||Degree Celsius||Standard Deviation|Mean
2527650|NCT03555890|Secondary|Part 2: Change From Baseline in Heart Rate|Heart rate was measured in supine position after 5 minutes rest. Change from Baseline in heart rate was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Beats per minute||Standard Deviation|Mean
2527651|NCT03555890|Secondary|Part 1: Change From Baseline in Heart Rate|Heart rate was measured in supine position after 5 minutes rest. Change from Baseline in heart rate was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose|Safety Population.|||Beats per minute||Standard Deviation|Mean
2527652|NCT03555890|Secondary|Part 2: Change From Baseline in SBP and DBP|Blood pressure was measured in supine position after 5 minutes rest. Change from Baseline in SBP and DBP was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||mmHg||Standard Deviation|Mean
2527653|NCT03555890|Secondary|Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure was measured in supine position after 5 minutes rest. Change from Baseline in SBP and DBP was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 1, 24, 48 hours post-dose|Safety Population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2527654|NCT03555890|Secondary|Part 2: Urine Specific Gravity|Urine samples were collected for the measurement of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030.|Pre-dose (Day 1) and 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Ratio||Standard Deviation|Mean
2527655|NCT03555890|Secondary|Part 1: Urine Specific Gravity|Urine samples were collected for the measurement of specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. The urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030.|Pre-dose (Day 1) and 48 hours post-dose|Safety Population.|||Ratio||Standard Deviation|Mean
2527656|NCT03555890|Secondary|Part 2: Urine Potential of Hydrogen (pH)|Urine samples were collected for the measurement of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Pre-dose (Day 1) and 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||pH||Standard Deviation|Mean
2527657|NCT03555890|Secondary|Part 1: Urine Potential of Hydrogen (pH)|Urine samples were collected for the measurement of urine pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Pre-dose (Day 1) and 48 hours post-dose|Safety Population.|||pH||Standard Deviation|Mean
2527805|NCT03550066|Primary|Acceptance of Health Message|Index of message acceptance: Persuasiveness (rated on a 7-point scale from not at all (1) to very (7), with higher mean scores corresponding to greater persuasiveness)|Up to 2 weeks|Analytic sample, after excluding participants with current diabetes or those already participating in a preventive program|||units on a scale||Standard Deviation|Mean
2527658|NCT03555890|Secondary|Part 2: Number of Participants With Urinalysis Results by Dipstick Method|Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-), trace and 1+ indicating proportional concentrations in the urine sample. Only categories with significant values have been presented.|Pre-dose (Day 1) and 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Participants|||Count of Participants
2527659|NCT03555890|Secondary|Part 1: Number of Participants With Urinalysis Results by Dipstick Method|Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen can be read as negative (-), trace and 1+ indicating proportional concentrations in the urine sample. Only categories with significant values have been presented.|Pre-dose (Day 1) and 48 hours post-dose|Safety Population.|||Participants|||Count of Participants
2527660|NCT03555890|Secondary|Part 2: Change From Baseline in Reticulocytes|Blood samples were collected for the assessment of hematology parameters. Change from Baseline in reticulocytes was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Percentage of reticulocytes||Standard Deviation|Mean
2527661|NCT03555890|Secondary|Part 1: Change From Baseline in Reticulocytes|Blood samples were collected for the assessment of hematology parameters. Change from Baseline in reticulocytes was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population.|||Percentage of reticulocytes||Standard Deviation|Mean
2527662|NCT03555890|Secondary|Part 2: Change From Baseline in Red Blood Cell Count|Blood samples were collected for the assessment of hematology parameters. Change from Baseline in red blood cell count was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Trillion cells per liter||Standard Deviation|Mean
2527663|NCT03555890|Secondary|Part 1: Change From Baseline in Red Blood Cell Count|Blood samples were collected for the assessment of hematology parameters. Change from Baseline in red blood cell count was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population.|||Trillion cells per liter||Standard Deviation|Mean
2527664|NCT03555890|Secondary|Part 2: Change From Baseline in Mean Corpuscle Volume|Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle volume was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Femtoliters||Standard Deviation|Mean
2527665|NCT03555890|Secondary|Part 1: Change From Baseline in Mean Corpuscle Volume|Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle volume was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population.|||Femtoliters||Standard Deviation|Mean
2527666|NCT03555890|Secondary|Part 2: Change From Baseline in Mean Corpuscle Hemoglobin|Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle hemoglobin was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Picograms||Standard Deviation|Mean
2527667|NCT03555890|Secondary|Part 1: Change From Baseline in Mean Corpuscle Hemoglobin|Blood samples were collected for the assessment of hematology parameters. Change from Baseline in mean corpuscle hemoglobin was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population.|||Picograms||Standard Deviation|Mean
2527668|NCT03555890|Secondary|Part 2: Change Form Baseline in Hematocrit|Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hematocrit was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2527669|NCT03555890|Secondary|Part 1: Change Form Baseline in Hematocrit|Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hematocrit was evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2528888|NCT03476278|Secondary|Mood State According to Age|Patients' mood state according to age|1 day||||Participants|||Count of Participants
2527670|NCT03555890|Secondary|Part 2: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration|Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||G/L||Standard Deviation|Mean
2527671|NCT03555890|Secondary|Part 1: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration|Blood samples were collected for the assessment of hematology parameters. Change from Baseline in hemoglobin and mean corpuscle hemoglobin concentration were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population.|||Grams per liter (G/L)||Standard Deviation|Mean
2527672|NCT03555890|Secondary|Part 2: Change From Baseline in Platelet Count and White Blood Cell Count|Blood samples were collected for the assessment of hematology parameters. Change from Baseline in platelet count and white blood cell count were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||GI/L||Standard Deviation|Mean
2527673|NCT03555890|Secondary|Part 1: Change From Baseline in Platelet Count and White Blood Cell Count|Blood samples were collected for the assessment of hematology parameters. Change from Baseline in platelet count and white blood cell count were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population.|||Giga per liter (GI/L)||Standard Deviation|Mean
2527674|NCT03555890|Secondary|Part 2: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count|Blood samples were collected for the assessment of hematology parameters. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes and total neutrophils levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Percentage||Standard Deviation|Mean
2527675|NCT03555890|Secondary|Part 1: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils Count|Blood samples were collected for the assessment of hematology parameters. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes and total neutrophils levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population.|||Percentage||Standard Deviation|Mean
2527676|NCT03555890|Secondary|Part 2: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/BUN Levels|Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/BUN levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||MMOL/L||Standard Deviation|Mean
2527677|NCT03555890|Secondary|Part 1: Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, High Density Lipids Cholesterol, Potassium, Low Density Lipids Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides and Urea/Blood Urea Nitrogen (BUN) Levels|Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in calcium, cholesterol, chloride, glucose, high density lipids cholesterol, potassium, low density lipids cholesterol, sodium, phosphorus inorganic, triglycerides and urea/blood urea nitrogen (BUN) levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population.|||Millimoles per liter (MMOL/L)||Standard Deviation|Mean
2527678|NCT03555890|Secondary|Part 2: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels|Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in direct bilirubin, total bilirubin, creatinine and uric acid levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||UMOL/L||Standard Deviation|Mean
2527679|NCT03555890|Secondary|Part 1: Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Levels|Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in direct bilirubin, total bilirubin, creatinine and uric acid levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population.|||Micromoles per liter (UMOL/L)||Standard Deviation|Mean
2527807|NCT03549429|Secondary|Patient Satisfaction|Patient Satisfaction will be based on one question and graded on a Likert Scale from 1-5. A score of 5 is considered better (higher satisfaction), while a 1 is considered lower. There are no subscales.|post-operation||||Units on a scale of 1-5||Standard Deviation|Mean
2527680|NCT03555890|Secondary|Part 2: Change From Baseline in Amylase Levels|Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in amylase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||U/L||Standard Deviation|Mean
2527681|NCT03555890|Secondary|Part 1: Change From Baseline in Amylase Levels|Blood samples were collected for the assessment of clinical chemistry parameters. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population.|||Units per liter (U/L)||Standard Deviation|Mean
2527682|NCT03555890|Secondary|Part 2: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels|Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||IU/L||Standard Deviation|Mean
2527683|NCT03555890|Secondary|Part 1: Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase Levels|Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase, gamma glutamyl transferase and lactate dehydrogenase levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population.|||International units per liter (IU/L)||Standard Deviation|Mean
2527684|NCT03555890|Secondary|Part 2: Change From Baseline in Albumin and Total Protein Levels|Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in albumin and total protein levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed.|||g/L||Standard Deviation|Mean
2527685|NCT03555890|Secondary|Part 1: Change From Baseline in Albumin and Total Protein Levels|Blood samples were collected for the assessment of clinical chemistry parameters. Change from Baseline in albumin and total protein levels were evaluated. The Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1, Pre-dose) and 48 hours post-dose|Safety Population.|||Grams per liter (g/L)||Standard Deviation|Mean
2527686|NCT03555890|Secondary|Part 2: Number of Participants With AEs and SAEs|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose may results in death or is life-threatening or requires inpatient hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Up to 18 days|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Participants|||Count of Participants
2527687|NCT03555890|Secondary|Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is defined as any untoward medical occurrence that, at any dose may results in death or is life-threatening or requires inpatient hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.|Up to 18 days|Safety Population consists of all participants who were administered at least one dose of study treatment.|||Participants|||Count of Participants
2527688|NCT03555890|Secondary|Part 2: MRT of Levocetirizine|Blood samples were collected at indicated time points for analysis of MRT. MRT of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed.|||Hours||95% Confidence Interval|Geometric Mean
2527689|NCT03555890|Secondary|Part 1: Mean Residence Time (MRT) of Levocetirizine|Blood samples were collected at indicated time points for analysis of MRT. MRT of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose|PK Population|||Hours||95% Confidence Interval|Geometric Mean
2527690|NCT03555890|Secondary|Part 2: Kel (lambda_z) of Levocetirizine|Blood samples were collected at indicated time points for analysis of kel. kel (lambda_z) is the first order rate constant associated with the terminal (log-linear) portion of the curve. kel of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed.|||Per hour||95% Confidence Interval|Geometric Mean
2527998|NCT03535571|Secondary|Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine TGF-Beta After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)|Measured by the Multi-Analyte ELISArray|Baseline (Day 0) to end-of-study (Day 128)|This measure was not included in the Multi-Analyte ELISArray analysis, therefore there is no data to report.||||||
2527691|NCT03555890|Secondary|Part 1: Elimination Rate Constant (Kel) (lambda_z) of Levocetirizine|Blood samples were collected at indicated time points for analysis of kel. kel (lambda_z) is the first order rate constant associated with the terminal (log-linear) portion of the curve. kel of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose|PK Population|||Per hour||95% Confidence Interval|Geometric Mean
2527692|NCT03555890|Secondary|Part 2: Vz/F of Levocetirizine|Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated as by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed.|||Liters||95% Confidence Interval|Geometric Mean
2527693|NCT03555890|Secondary|Part 1: Apparent Volume of Distribution Following Oral Dosing (Vz/F) of Levocetirizine|Blood samples were collected at indicated time points for analysis of Vz/F. Vz/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose|PK Population|||Liters||95% Confidence Interval|Geometric Mean
2527694|NCT03555890|Secondary|Part 2: CL/F of Levocetirizine|Blood samples were collected at indicated time points for analysis of CL/F. CL/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed.|||Liters per hour||95% Confidence Interval|Geometric Mean
2527695|NCT03555890|Secondary|Part 1: Apparent Clearance Following Oral Dosing (CL/F) of Levocetirizine|Blood samples were collected at indicated time points for analysis of CL/F. CL/F of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose|PK Population|||Liters per hour||95% Confidence Interval|Geometric Mean
2527696|NCT03555890|Secondary|Part 2: %AUCex of Levocetirizine|Blood samples were collected at indicated time points for analysis of %AUCex. Percentage AUCex of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed.|||Percentage AUCex||95% Confidence Interval|Geometric Mean
2527697|NCT03555890|Secondary|Part 1: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) of Levocetirizine|Blood samples were collected at indicated time points for analysis of %AUCex. Percentage AUCex of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose|PK Population|||Percentage AUCex||95% Confidence Interval|Geometric Mean
2527698|NCT03555890|Secondary|Part 2: t1/2 of Levocetirizine|Blood samples were collected at indicated time points for analysis of t1/2. The t1/2 of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed.|||Hours||95% Confidence Interval|Geometric Mean
2527699|NCT03555890|Secondary|Part 1: Apparent Terminal Phase Half-life (t1/2) of Levocetirizine|Blood samples were collected at indicated time points for analysis of t1/2. The t1/2 of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose|PK Population|||Hours||95% Confidence Interval|Geometric Mean
2527700|NCT03555890|Secondary|Part 2: Tmax of Levocetirizine|Blood samples were collected at indicated time points for analysis of tmax. The tmax of levocetirizine was obtained directly from the concentration-time data. The tmax was analyzed with the non-parametric Wilcoxon Matched Pairs Method (Signed Rank Method) to compute point estimate and associated 90% confidence interval for the median difference.|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed.|||Hours||Full Range|Median
2527701|NCT03555890|Secondary|Part 1: Time to First Occurrence of Cmax (Tmax) of Levocetirizine|Blood samples were collected at indicated time points for analysis of tmax. The tmax of levocetirizine was obtained directly from the concentration-time data. The tmax was analyzed with the non-parametric Wilcoxon Matched Pairs Method (Signed Rank Method) to compute point estimate and associated 90% confidence interval for the median difference.|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose|PK Population|||Hours||Full Range|Median
2527702|NCT03555890|Secondary|Part 2: AUC(0-inf) of Levocetirizine|Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed.|||Hr*ng/mL||95% Confidence Interval|Geometric Mean
2527703|NCT03555890|Secondary|Part 1: Area Under the Concentration-time Curve From Zero Time (Pre-dose) Extrapolated to Infinite Time AUC(0-inf) of Levocetirizine|Blood samples were collected at indicated time points for analysis of AUC(0-inf). AUC(0-inf)) of levocetirizine was calculated by standard non-compartmental analysis using the currently supported version of WinNonlin (version 6.3 or higher).|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36 and 48 hours post-dose|PK Population|||Hr*ng/mL||95% Confidence Interval|Geometric Mean
2527704|NCT03555890|Primary|Part 2: Cmax of Levocetirizine|Blood samples were collected at indicated time points for analysis of Cmax. The values for Cmax were obtained directly from the concentration-time data.|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed.|||ng/mL||95% Confidence Interval|Geometric Mean
2527706|NCT03555890|Primary|Part 2: AUC(0-t) of Levocetirizine|Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin).|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed.|||Hr*ng/mL||95% Confidence Interval|Geometric Mean
2527707|NCT03555890|Primary|Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero Time (Pre-dose) to the Time of Last Quantifiable Concentration (AUC[0-t]) of Levocetirizine|Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) was calculated by the linear trapezoidal method (i.e., Linear Trapezoidal Linear Interpolation calculation method in Phoenix WinNonlin).|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48 hours post-dose|Pharmacokinetic (PK) Population is defined as all participants who were administered at least one dose of study treatment and blood samples for plasma drug concentration were taken and analyzed.|||Hours*nanogram per milliliter (Hr*ng/mL)||95% Confidence Interval|Geometric Mean
2527708|NCT03554746|Secondary|Functional Ability|PSFS (0-10) Maximum: 10 Minimal: 0 higher scores mean a better outcome|change from baseline at 6 weeks later||||score on a scale||Standard Deviation|Mean
2527709|NCT03554746|Secondary|Functional Disability|Oswestry disability index (ODI) Maximum: 100 Minimal: 0 higher scores mean a worse outcome|change from baseline at 6 weeks later||||score on a scale||Standard Deviation|Mean
2527710|NCT03554746|Secondary|Pain Intensity|Visual Analog Scale (VAS) (0-10) Maximum: 10 Minimal: 0 higher scores mean a worse outcome|change from baseline at 6 weeks later||||score on a scale||Standard Deviation|Mean
2527711|NCT03554746|Primary|Pelvic Inclination|bilateral pelvic inclination|change from baseline at 6 weeks later||||degrees||Standard Deviation|Mean
2527712|NCT03554746|Primary|Ilium Anterior Tilt Difference|bilateral ilium anterior tilt difference|change from baseline at 6 weeks later||||degrees||Standard Deviation|Mean
2527713|NCT03554746|Primary|Leg Length Inequality|functional leg length inequality|change from baseline at 6 weeks later||||centemeter||Standard Deviation|Mean
2527714|NCT03554005|Secondary|Best Objective Response|Best Objective Response data were based on World Health Organization (WHO) criteria and included four categories. Complete Response (CR) was the disappearance of all clinically detectable malignant disease. Partial Response (PR) was a decrease of ≥50% of the sum of products of largest perpendicular diameters of all bidimensionally measurable lesions; and a decrease of ≥50% in sum of largest diameters of all unidimensionally measure lesions. Stable Disease (SD) was a <50% decrease or <25% increase in sum of products of largest perpendicular diameters of all bidimensionally measurable lesions; or a <50% decrease or <25% increase in sum of diameters of all unidimensionally measurable lesions. In addition, no new lesions appeared. Progressive Disease (PD) was a ≥25% increase in size of at least one bidimensionally or unidimensionally measurable lesion or appearance of new lesion. Occurrence of pleural effusion or ascites was also considered PD if substantiated by positive cytology.|Up to 40 Weeks|All enrolled participants|||Participants|||Count of Participants
2527715|NCT03554005|Primary|Number of Participants Who Discontinued Treatment Due to an Adverse Event|An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Up to 40 Weeks|All enrolled participants|||Participants|||Count of Participants
2527716|NCT03554005|Primary|Number of Participants Who Experienced an Adverse Event|An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Up to 42 Weeks|All enrolled participants|||Participants|||Count of Participants
2527717|NCT03552549|Secondary|Overall Survival|Overall survival (OS) is the time from randomization to death due to any cause. Participants were to be followed for survival every 3 months. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. After the early termination of the study, participants were followed for safety only. Although the OS analysis is not in the clinical study report due to early termination of the study, an OS ad hoc analysis was requested by the FDA and is therefore presented in this outcome measure. Below table presents the median duration of survival for participants.|From time of randomization to time of death (up to approximately 26 months)|All treated participants.|||Months||95% Confidence Interval|Median
2527718|NCT03552549|Primary|Progression-free Survival (PFS)|Progression-free survival time was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause. PFS was to be assessed by clinical observation, with recurrence documented by appropriate radiographic and histologic methods, and confirmed by Independent Central Review.|From time of randomization to time of progression or death (up to approximately 26 months)|All randomized participants. Due to the early termination of this study, confirmation of PFS by Independent Central Review was not collected and; therefore, PFS could not be analyzed as planned per protocol.||||||
2527719|NCT03552536|Secondary|t1/2 of TFV|Values of plasma TFV were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The apparent terminal half-life (t1/2) of plasma TFV is presented.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose|Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.|||hr.||Geometric Coefficient of Variation|Geometric Mean
2527720|NCT03552536|Secondary|Cmax of TFV|Values of plasma TFV were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The maximum concentration (Cmax) of plasma TFV is presented.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose|Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2527721|NCT03552536|Secondary|Tmax of TFV|Values of plasma TFV were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The time to achieve maximum concentration (Tmax) of plasma TFV is presented.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose|Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.|||hr.||Full Range|Median
2527722|NCT03552536|Secondary|AUC0-inf of TFV|Values of plasma TFV were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The area under the concentration time curve from time 0-infinity (AUC0-inf) of plasma TFV is presented.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose|Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.|||hr*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2527723|NCT03552536|Secondary|AUC0-last of Tenofovir (TFV)|Values of plasma TFV were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The area under the concentration time curve from time 0-last measurement (AUC0-last) of plasma TFV is presented.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose|Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.|||hr*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2527724|NCT03552536|Secondary|Apparent Volume of Distribution (Vz/F) of MK-8583|Values of plasma MK-8583 were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose|Due to insufficient plasma concentration data at the terminal phase, Vz/F of plasma MK-8583 was not able to be calculated for any participants. Participants from Panels B and C were not analyzed because they were not enrolled in the study.||||||
2527725|NCT03552536|Secondary|Apparent Total Clearance (CL/F) of MK-8583|Values of plasma MK-8583 were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The apparent total clearance (CL/F) of plasma MK-8583 is presented.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose|Due to insufficient plasma concentration data at the terminal phase, CL/F of plasma MK-8583 was not able to be calculated for any participants. Participants from Panels B and C were not analyzed because they were not enrolled in the study.||||||
2527726|NCT03552536|Secondary|t1/2 of MK-8583|Values of plasma MK-8583 were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose|Due to insufficient plasma concentration data at the terminal phase, t1/2 of plasma MK-8583 was not able to be calculated for any participants. Participants from Panels B and C were not analyzed because they were not enrolled in the study.||||||
2527727|NCT03552536|Secondary|Cmax of MK-8583|Values of plasma MK-8583 were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The maximum concentration (Cmax) of plasma MK-8583 is presented.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose|Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2527728|NCT03552536|Secondary|Tmax of Plasma MK-8583.|Values of plasma MK-8583 were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The time to achieve maximum concentration (Tmax) of plasma MK-8583 is presented.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose|Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.|||hr.||Full Range|Median
2527729|NCT03552536|Secondary|Area Under the Concentration Time Curve From Time 0-infinity (AUC0-inf) of MK-8583|Values of plasma MK-8583 were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose|Due to insufficient plasma concentration data at the terminal phase, AUC0-inf of plasma MK-8583 was not able to be calculated for any participants. Participants from Panels B and C were not analyzed because they were not enrolled in the study.||||||
2527730|NCT03552536|Secondary|Area Under the Concentration Time Curve From Time 0-last Measurement (AUC0-last) of MK-8583|Values of plasma MK-8583 were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The area under the concentration time curve from time 0-last measurement (AUC0-last) of plasma MK-8583 is presented. The last quantified concentration value occurred at 2 hours (n=4) and 4 hours (n=1).|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours postdose|Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.|||hr*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2527731|NCT03552536|Secondary|Apparent Terminal Half-life (t1/2) of TFV-DP|Values of TFV-DP in PBMCs were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The apparent terminal half-life (t1/2) of intracellular TFV-DP is presented.|Pre-dose, 4, 12, 24, 48, 72, 96, 168, 240, 312 and 672 hours postdose|Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment. One participant who had insufficient data on terminal phase was not included in the analysis. Participants from Panels B and C were not analyzed because they were not enrolled in the study.|||hr.||Geometric Coefficient of Variation|Geometric Mean
2527999|NCT03535571|Secondary|Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-13 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).|Measured by the Multi-Analyte ELISArray|Baseline (Day 0) to end-of-study (Day 128)|Intent to treat population|||pg/mL||Standard Deviation|Mean
2527732|NCT03552536|Secondary|Concentration at 168 Hours Postdose (C168hr) of TFV-DP|Values of TFV-DP in PBMCs were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The concentration at 168 hours postdose (C168hr) of TFV-DP is presented. It is hypothesized that the true geometric mean (GM) of TFV-DP in PBMC is ≥ 0.1 μM (100 nmol/L).|168 hr postdose|Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment. The PBMC sample from one participant was processed incorrectly, so was not included in the analysis. Participants from Panels B and C were not analyzed because they were not enrolled in the study.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2527733|NCT03552536|Secondary|Maximum Concentration (Cmax) of TFV-DP|Values of TFV-DP in PBMCs were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The maximum concentration (Cmax) of intracellular TFV-DP is presented.|Pre-dose, 4, 12, 24, 48, 72, 96, 168, 240, 312 and 672 hours postdose|Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2527734|NCT03552536|Secondary|Time to Achieve Maximum Concentration (Tmax) of TFV-DP|Values of TFV-DP in PBMCs were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The time to achieve maximum concentration (Tmax) of intracellular TFV-DP is presented.|Pre-dose, 4, 12, 24, 48, 72, 96, 168, 240, 312 and 672 hours postdose|Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.|||hr.||Full Range|Median
2527735|NCT03552536|Secondary|Area Under the Concentration Time Curve From Time 0-168 Hours Postdose (AUC0-168hr) of Tenofovir Diphosphate (TFV-DP)|Values of TFV-DP in peripheral blood mononuclear cells (PBMCs) were natural-log transformed and analyzed based on a linear model containing a fixed effect for the MK-8583 100-mg dose. The area under the concentration time curve from time 0-168 hours post-dose (AUC0-168hr) for intracellular TFV-DP is presented.|Pre-dose, 4, 12, 24, 48, 72, 96, and 168 hours postdose|Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.|||hr*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2527736|NCT03552536|Primary|Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at 168 Hours Post-dose.|Plasma HIV-1 RNA was measured at baseline and 168 hours after dosing. Change from baseline for MK-8583 at 168 hours post-baseline was estimated from longitudinal data analysis (LDA) model containing fixed effects for time (predose, 168 hours postdose) and a random effect for participant. The change from baseline in plasma HIV-1 RNA in participants administered MK-8583 was compared with historical placebo data.|Baseline (pre-dose) and 168 hours post-dose.|Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants from Panels B and C were not analyzed because they were not enrolled in the study.|||log10 copies/mL||95% Confidence Interval|Least Squares Mean
2527737|NCT03552536|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Day 1|All participants who received at least one dose of treatment. Participants from Panels B and C were not analyzed because they were not enrolled in the study.|||Participants|||Count of Participants
2527738|NCT03552536|Primary|Number of Participants With at Least One Adverse Event (AE)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to Day 29|All participants who received at least one dose of treatment. Participants from Panels B and C were not analyzed because they were not enrolled in the study.|||Participants|||Count of Participants
2527739|NCT03552523|Primary|Average Time Spent With CGMG Less Than 54 mg/dl|Using glucose information collected from the Dexcom device we will establish percentage of time spent in a hypoglycemia threshold range|days 2-7|Only completed study arms are analyzed. 7 subjects started participating, but only 5 subjects completed both study arms. 2 subjects withdrew during the first study arm.|||percentage of time||Standard Deviation|Mean
2527740|NCT03552523|Primary|Mean Dexcom CGM Glucose (CGMG) Level|Average glucose value from the information collected by the Dexcom CGM device during the control and experimental arms.|days 2-7|Only completed study arms are analyzed. 7 subjects started participating, but only 5 subjects completed both study arms. 2 subjects withdrew during the first study arm.|||mg/dl||Standard Deviation|Mean
2527741|NCT03551821|Secondary|Subject's Eyebrow Assessment|"Determination of the amount of hair in the affected area.~Subject's Eyebrow Assessment Grade Descriptor 0 No eyebrow hair: No thick, coarse hairs are visible in the affected area(s)~A little eyebrow hair: A few thick, coarse hairs are visible in the affected area(s)~Some eyebrow hair: Numerous thick, coarse hairs are visible in the affected area(s)~Most eyebrow hair: The majority of the affected area(s) of the eyebrow is covered in thick, coarse hairs~Full eyebrow hair: The affected area(s) of the eyebrow is fully covered in thick, coarse hairs"|Six months||||score on a scale|||Number
2532191|NCT03314233|Secondary|Mortality in First 7 Days of Life|Proportion of infants with mortality in the first 7 days of life|First 7 days of life||||Participants|||Count of Participants
2527742|NCT03551821|Primary|Clinician's Eyebrow Assessment|"Determination of the amount of hair in the affected area.~Clinician's Eyebrow Assessment~Grade Descriptor 0 No eyebrow hair: No terminal hairs are visible in the affected area(s)~A little eyebrow hair: Occasional terminal hairs are visible in the affected area(s)~Some eyebrow hair: Numerous terminal hairs are visible in the affected area(s)~Most eyebrow hair: Mostly complete eyebrow regrowth with terminal hair in the affected area(s)~Full eyebrow hair: Complete eyebrow regrowth with terminal hair in the affected area(s)"|Six months||||score on a scale|||Number
2527743|NCT03551743|Secondary|Andexanet Total Volume of Distribution (Vss)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Vss was calculated using a non-compartmental approach.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.||||L||Standard Deviation|Mean
2527744|NCT03551743|Secondary|Andexanet Total Systemic Clearance (CL)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. CL was calculated using a non-compartmental approach.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet are included in the PK analysis for andexanet|||L/hr||Standard Deviation|Mean
2527745|NCT03551743|Secondary|Andexanet Apparent Terminal Elimination Half-life (t1/2)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. t1/2 was determined by linear regression of the log concentration on the terminal portion of the plasma concentration-time curve.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet are included in the PK analysis for andexanet|||hr||Standard Deviation|Mean
2527746|NCT03551743|Secondary|Andexanet Time of Maximum Observed Plasma Concentration (Tmax)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Tmax was taken directly from the raw data.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet are included in the PK analysis for andexanet|||hr||Full Range|Median
2527747|NCT03551743|Secondary|Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf )|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. AUC0-inf was calculated using a non-compartmental approach|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet are included in the PK analysis for andexanet|||ng*hr/mL||Standard Deviation|Mean
2527748|NCT03551743|Secondary|Andexanet Maximum Observed Plasma Concentration (Cmax)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Maximum observed plasma concentration was taken directly from the raw data.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet are included in the PK analysis for andexanet|||ng/mL||Standard Deviation|Mean
2527749|NCT03551743|Secondary|Efficacy: Percent Change From Baseline in Unbound Edoxaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration|Unbound edoxaban concentrations was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Unbound plasma concentrations for edoxaban was determined by a rapid equilibrium dialysis method followed by Liquid chromatography- Mass Spectrometry.|Baseline to 2 minutes following the end of andexanet/placebo administration|26 subjects who received edoxaban were included in the edoxaban pharmacokinetics (PK) analysis|||Percent change in unbound edoxaban conce||Standard Deviation|Mean
2527750|NCT03551743|Secondary|Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration|Thrombin generation was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Thrombin generation was measured using a TF-initiated thrombin generation assay.|Baseline to 2 minutes following the end of andexanet/placebo administration|26 subjects who received andexanet or placebo were included in the PD analysis|||Percent change in thrombin generation||Standard Deviation|Mean
2527751|NCT03551743|Primary|Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration|Anti-fXa activity was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Anti-fXa activity was measured using a commercial kit (Coamatic Heparin-82 33 9363, DiaPharma)|Baseline to 2 minutes following the end of andexanet/placebo administration|26 subjects who received andexanet or placebo were included in the pharmacodynamics (PD) analysis|||Percent change in anti-fXa activity||Standard Deviation|Mean
2527752|NCT03551730|Secondary|Andexanet Total Volume of Distribution (Vss)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Vss was calculated using a non-compartmental approach.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet were included in the andexanet PK analysis|||L||Standard Deviation|Mean
2527753|NCT03551730|Secondary|Andexanet Total Systemic Clearance (CL)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. CL was calculated using a non-compartmental approach.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet were included in the andexanet PK analysis|||L/hr||Standard Deviation|Mean
2527754|NCT03551730|Secondary|Andexanet Apparent Terminal Elimination Half-life (t1/2)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay.t1/2 was determined by linear regression of the log concentration on the terminal portion of the plasma concentration-time curve.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet were included in the andexanet PK analysis|||hr||Standard Deviation|Mean
2528466|NCT03508050|Primary|T50-3|Moment where the probability of having a complete lung collapse is 50%|From the beginning of surgery (pleural opening) until 120 minutes||||minutes||Standard Deviation|Mean
2527755|NCT03551730|Secondary|Andexanet Time of Maximum Observed Plasma Concentration (Tmax)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Tmax was taken directly from the raw data.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet were included in the andexanet PK analysis|||hr||Full Range|Median
2527756|NCT03551730|Secondary|Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf )|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. AUC0-inf was calculated using a non-compartmental approach|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet were included in the andexanet PK analysis|||ng*hr/mL||Standard Deviation|Mean
2527757|NCT03551730|Secondary|Andexanet Maximum Observed Plasma Concentration (Cmax)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Cmax was taken directly from the raw data.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|18 subjects who received andexanet were included in the andexanet pharmacokinetics (PK) analysis|||ng/mL||Standard Deviation|Mean
2527758|NCT03551730|Secondary|Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration|Thrombin generation was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Thrombin generation was measured using a TF-initiated thrombin generation assay.|Baseline to 2 minutes following the end of andexanet/placebo administration|26 subjects who received andexanet or placebo were included in the PD analysis|||Percent change in thrombin generation||Standard Deviation|Mean
2527759|NCT03551730|Primary|Efficacy:Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration Activity|Anti-fXa activity was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Anti-fXa activity was measured using a commercial kit (Coamatic Heparin-82 33 9363, DiaPharma)|Baseline to 2 minutes following the end of andexanet/placebo administration|26 subjects who received andexanet or placebo were included in the pharmacodynamics (PD) analysis|||Percent change in anti-fXa activity||Standard Deviation|Mean
2527760|NCT03550989|Secondary|PM2.5 Particles [µg/m^3]|Real-time measurements of PM2.5 suspended particles in air. (ISO Norm 18144:2003)|Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.||||µg/m^3||95% Confidence Interval|Mean
2527761|NCT03550989|Secondary|PM1 Particles [µg/m^3]|Real-time measurements of PM1 suspended particles in air. (ISO Norm 18144:2003)|Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.||||µg/m^3||95% Confidence Interval|Mean
2527762|NCT03550989|Secondary|NNK [µg/m^3]|"To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)~Note that the measurements of NNK [µg/m3] were below the limit of detection."|Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.||||µg/m^3|||Number
2527763|NCT03550989|Secondary|NNN [µg/m^3]|"To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)~Note that the measurements were below the limit of detection."|Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.||||µg/m^3|||Number
2527764|NCT03550989|Secondary|Formaldehyde [µg/m^3]|To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)|Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.||||µg/m^3||95% Confidence Interval|Geometric Mean
2527765|NCT03550989|Secondary|Crotonaldehyde [µg/m^3]|To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)|Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.||||µg/m^3||95% Confidence Interval|Geometric Mean
2527766|NCT03550989|Secondary|Acrolein [µg/m^3]|To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)|Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.||||µg/m^3||95% Confidence Interval|Geometric Mean
2527767|NCT03550989|Secondary|Acetaldehyde [µg/m^3]|To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)|Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.||||µg/m^3||95% Confidence Interval|Geometric Mean
2527768|NCT03550989|Secondary|Nicotine [µg/m^3]|To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)|Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.||||µg/m^3||95% Confidence Interval|Geometric Mean
2527769|NCT03550989|Secondary|3-Ethenylpyridine (3-EP) [µg/m^3]|"To measure IAQ, in real-time, through the assessment of concentrations of nicotine and select HPHCs representative of ETS in the air of the study site. (ISO Norm 18144:2003)~Note that the measurements of 3-EP [µg/m^3] were below the limit of detection."|Measured at baseline for up to 3h prior to start of the event, then continuously during the event until 3h after the last participant has entered the event for 1h.||||µg/m^3|||Number
2528112|NCT03527966|Secondary|Mean Postoperative Leg/Back Pain Score|Pain scores are obtained using the numeric rating scale of 0-no pain, to 10-worst pain possible|Average of 3 days in hospital|Study was terminated early before any patients were randomized to the control group.|||score on a scale||Full Range|Mean
2527770|NCT03550989|Secondary|HEMA (Exposure Events)|To measure 2-hydroxyethyl mercapturic acid (HEMA, a BoExp to Ethylene Oxide) in spot urine (concentration adjusted for creatinine), during exposure events where some subjects used IQOS.|Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).|Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).|||ng/g||95% Confidence Interval|Geometric Mean
2527771|NCT03550989|Secondary|HEMA (Non-Exposure Events)|To measure 2-hydroxyethyl mercapturic acid (HEMA, a BoExp to Ethylene Oxide) in spot urine (concentration adjusted for creatinine).|Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).|Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).|||ng/g||95% Confidence Interval|Geometric Mean
2527772|NCT03550989|Secondary|S-PMA (Exposure Events)|To measure S-phenylmercapturic acid (S-PMA, a BoExp to Benzene ) in spot urine (concentration adjusted for creatinine), during exposure events where some subjects used IQOS.|Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).|Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).|||ng/g||95% Confidence Interval|Geometric Mean
2527773|NCT03550989|Secondary|S-PMA (Non-Exposure Events)|To measure S-phenylmercapturic acid (S-PMA, a BoExp to Benzene) in spot urine (concentration adjusted for creatinine).|Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).|Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).|||ng/g||95% Confidence Interval|Geometric Mean
2527774|NCT03550989|Secondary|3-HPMA (Exposure Events)|To measure 3 hydroxypropylmercapturic acid (3-HPMA, a BoExp to Acrolein) in spot urine (concentration adjusted for creatinine), during exposure events where some subjects used IQOS.|Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).|Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).|||μg/g||95% Confidence Interval|Geometric Mean
2527775|NCT03550989|Secondary|3-HPMA (Non-Exposure Events)|To measure 3 hydroxypropylmercapturic acid (3-HPMA, a BoExp to Acrolein) in spot urine (concentration adjusted for creatinine).|Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).|Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).|||μg/g||95% Confidence Interval|Geometric Mean
2527776|NCT03550989|Secondary|HPMA (Exposure Events)|To measure 3-hydroxy-1-methylpropylmercapturic acid (HMPMA, a BoExp to Crotonaldehyde ) in spot urine (concentration adjusted for creatinine), during exposure events where some subjects used IQOS.|Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).|Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).|||μg/g||95% Confidence Interval|Geometric Mean
2527777|NCT03550989|Secondary|HPMA (Non-Exposure Events)|To measure 3-hydroxy-1-methylpropylmercapturic acid (HMPMA, a BoExp to Crotonaldehyde ) in spot urine (concentration adjusted for creatinine).|Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).|Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).|||μg/g||95% Confidence Interval|Geometric Mean
2527778|NCT03550989|Primary|Total NNN: (Exposure Event)|To measure Total N-nitrosonornicotine (Total NNN, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine) during exposure events where some subjects used IQOS.|Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).|Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).|||ng/g||95% Confidence Interval|Geometric Mean
2527779|NCT03550989|Primary|Total NNN: (Non-Exposure Event)|To measure Total N-nitrosonornicotine (Total NNN, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine).|Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).|Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).|||ng/g||95% Confidence Interval|Geometric Mean
2527780|NCT03550989|Primary|Total NNAL: (Exposure Event)|To measure Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine), during exposure events where some subjects used IQOS.|Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).|Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).|||ng/g||95% Confidence Interval|Geometric Mean
2528467|NCT03507569|Secondary|Number of Participants With Adverse Events (AEs)||From treatment initiation until 14 days after the last dose of study treatment.||||Participants|||Number
2527781|NCT03550989|Primary|Total NNAL: (Non-Exposure Event)|To measure Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL, a BoExp to Tobacco Specific Nitrosamines) in spot urine (expressed as concentration adjusted to creatinine).|Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).|Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).|||ng/g||95% Confidence Interval|Geometric Mean
2527782|NCT03550989|Primary|NEQ: (Exposure Event)|To measure nicotine equivalents (NEQ, a biomarker of exposure to Nicotine): molar sum of free nicotine, nicotine-glucuronide, free cotinine, cotinine-glucuronide, free trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-glucuronide in spot urine (expressed as concentration adjusted to creatinine), during exposure events where some subjects used IQOS.|Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).|Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).|||mg/g||95% Confidence Interval|Geometric Mean
2527783|NCT03550989|Primary|NEQ: (Non-Exposure Event)|To measure nicotine equivalents (NEQ, a biomarker of exposure to Nicotine): molar sum of free nicotine, nicotine-glucuronide, free cotinine, cotinine-glucuronide, free trans-3'-hydroxycotinine, trans-3'-hydroxycotinine-glucuronide in spot urine (expressed as concentration adjusted to creatinine).|Measured in a baseline urine sample collected before the start of the event and in a final urine sample taken prior to leaving the event (4h exposure, minimum 2h exposure).|Some participants were excluded from analysis for protocol deviations (including but not limited to, missing questionnaires, attended events but was not eligible to attend, assigned to an incorrect group, or missing samples).|||mg/g||95% Confidence Interval|Geometric Mean
2527784|NCT03550378|Secondary|Number of Participants With Positive Anti-drug Antibodies (ADA) Titre to MEDI0382|Number of participants with positive Anti-drug antibodies (ADA) Titre to MEDI0382 is reported.|Pre-dose on Days 1, 12, and 32 and on Day 60|As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2527785|NCT03550378|Secondary|Trough Plasma Concentration (Ctrough) of MEDI0382|Trough concentration is the lowest concentration reached by a drug before the next dose is administered. Trough plasma concentration of MEDI0382 is reported.|Days 1, 5, 12, and 19: Predose; and Day 32: Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose (Day 33)|"The PK population included all participants who received at least 1 dose of study drug and had at least one PK sample collected with a value above the lower limit of quantitation. Here, n signifies only the participants with available data were analyzed for the specified time points."|||ng/mL||Full Range|Geometric Mean
2527786|NCT03550378|Secondary|Time to Observed Maximum Serum Concentration (Tmax) of MEDI0382 at 300 μg|Time to observed maximum serum concentration (Tmax) of MEDI0382 at 300 μg is reported.|Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose on Day 32|The PK population included all participants who received at least 1 dose of study drug and had at least one PK sample collected with a value above the lower limit of quantitation.|||Hours||Full Range|Median
2527787|NCT03550378|Secondary|Maximum Observed Serum Concentration (Cmax) of MEDI0382 at 300 μg|Maximum observed serum concentration (Cmax) of MEDI0382 at 300 μg is reported.|Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose on Day 32|The PK population included all participants who received at least 1 dose of study drug and had at least one PK sample collected with a value above the lower limit of quantitation.|||ng/mL||Full Range|Geometric Mean
2527788|NCT03550378|Secondary|Area Under the Plasma Concentration Time Curve Over a Dosing Duration (AUCτ) of MEDI0382 at 300 μg|Area under the plasma concentration time curve over a dosing duration (AUCτ) of MEDI0382 at 300 μg is reported.|Predose and at 0.5, 1, 2, 4, 6, 8, and 24 hrs postdose on Day 32|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study drug and had at least one PK sample collected with a value above the lower limit of quantitation.|||ng.hr/mL||Full Range|Geometric Mean
2527789|NCT03550378|Secondary|Change From Baseline in Absolute Body Weight to Day 33|Change from baseline in absolute body weight is reported.|Day 1 (Baseline) and Day 33|"An ITT population included all participants who received any dose of study drug and analyzed according to their randomized treatment group. Here, N signifies only the participants with available data were analyzed for the outcome measure."|||Kg||Standard Deviation|Mean
2527790|NCT03550378|Secondary|Percent Change Frome Baseline in Body Weight to Day 33|Percent change from baseline in body weight is reported.|Day 1 (Baseline) and Day 33|"An ITT population included all participants who received any dose of study drug and analyzed according to their randomized treatment group. Here, N signifies only the participants with available data were analyzed for the outcome measure."|||Percent change in body weight||90% Confidence Interval|Least Squares Mean
2527791|NCT03550378|Secondary|Change From Baseline in Percentage of Time Spent Within a Target Glucose Range Over a 7-day Period to the Final Week of Treatment|Change from baseline in percentage of time spent within a target glucose range over a 7-day period to the final week of treatment is reported. Target glucose range was considered as 70 mg/dL (3.9 mmol/L) to 180 mg/dL (10 mmol/L).|Baseline (Days -8 to -2), Days 5 to 11, Days 12 to 18, Days 19 to 25, and Days 26 to 32 (final week of treatment)|"An ITT population included all participants who received any dose of study drug and analyzed according to their randomized treatment group. Here, n signifies only the participants with available data were analyzed for the specified time points."|||Percentage of time||90% Confidence Interval|Least Squares Mean
2527792|NCT03550378|Secondary|Change From Baseline in Fasting Glucose to Day 32|Change from baseline in fasting glucose is reported.|Day 1 (Baseline) and Day 32|"An ITT population included all participants who received any dose of study drug and analyzed according to their randomized treatment group. Here, N signifies only the participants with available data were analyzed for the outcome measure."|||mg/dL||90% Confidence Interval|Least Squares Mean
2527793|NCT03550378|Secondary|Change From Baseline in Haemoglobin A1c (HbA1c) to Day 32|Change from baseline in haemoglobin A1c (HbA1c) is reported.|Day 1 (Baseline) and Day 32|"Intent-to-treat (ITT) population included all participants who received any dose of study drug and analyzed according to their randomized treatment group. Here, N signifies only the participants with available data were analyzed for the outcome measure."|||Percent||90% Confidence Interval|Least Squares Mean
2527794|NCT03550378|Secondary|Change From Baseline in Mean 24-hrs Systolic and Diastolic Blood Pressure to the End of Each Dosing Level|Change from baseline in mean 24-hrs systolic and diastolic blood pressure to the end of each dosing levels: Day 5 for 50 μg, Day 12 for 100 μg, Day 19 for 200 μg, and Day 32 for 300 μg.|Day -5 (Baseline) and on Days 5, 12, 19, and 32|"As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Here, n signifies only the participants with available data were analyzed for the specified time points."|||mmHg||Standard Deviation|Mean
2527795|NCT03550378|Secondary|Change From Baseline in Mean 24-hrs Pulse Rate to the End of Each Dosing Level|Change from baseline in mean 24-hrs pulse rate to the end of each dosing levels: Day 5 for 50 μg; Day 12 for 100 μg, Day 19 for 200 μg, and Day 32 for 300 μg.|Day -5 (Baseline) and on Days 5, 12, 19, and 32|"As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Here, n signifies only the participants with available data were analyzed for the specified time points."|||Beats/min||Standard Deviation|Mean
2527796|NCT03550378|Secondary|Number of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs)|An adverse event of special interest (AESI) was one of scientific and medical interest specific to understanding of the study drug and may require close monitoring and rapid communication by the investigator to the sponsor.|Day 1 through Day 60|As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2527797|NCT03550378|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs|Number of participants with abnormal clinical laboratory parameters reported as TEAEs is reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of serum chemistry, hematology, and urine.|Day 1 through Day 60|As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2527798|NCT03550378|Secondary|Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs|Number of participants with abnormal ECGs reported as TEAEs is reported. Abnormal ECGs is defined as any abnormal findings in heart rate, RR interval, PR interval, QRS, axis, ST-T morphology, and QT intervals from the primary lead of the digital 12-lead ECG.|Day 1 through Day 60|As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2527799|NCT03550378|Secondary|Change From Baseline in Postural Blood Pressure|The change difference is the change from Day 1 to Day 32 in the difference between systolic blood pressure (SBP) or diastolic blood pressure (DBP) values in standing and supine positions. For this outcome measure, participants with difference (standing-supine) in DBP or SBP on Day 1 and Day 32 were analyzed. For few participants either DBP or SBP was recorded eg, standing DBP was not recorded on Day 1 for 2 participants in Placebo arm and 1 participant in MEDI0382 arm; standing SBP was not recorded on Day 32 for a participant in the Placebo arm.|Baseline (Day 1) through Day 32|As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Participants with difference (standing-supine) in DBP or SBP on Day 1 and the participants with difference (standing-supine) in DBP or SBP on Day 32 were analyzed.|||mmHg||Standard Deviation|Mean
2527800|NCT03550378|Secondary|Number of Participants With Abnormal Vital Signs Reported as TEAEs|Number of participants with abnormal vital signs reported as TEAEs is reported. Vital sign measurements were obtained after the participant had rested in the supine position for at least 10 minutes at the recording time. Abnormal vital signs is defined as any abnormal finding in the vital sign parameters (blood pressure, pulse rate, body temperature, and respiratory rate).|Day 1 through Day 60|As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2527801|NCT03550378|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.|Day 1 through Day 60|As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2527802|NCT03550378|Primary|Percent Change From Baseline in Plasma Glucose Area Under the Concentration Time-curve From Time 0 to 4 Hours (AUC0-4 Hrs) as Measured by Mixed-meal Tolerance Test (MMTT) to Day 32|The MMTT involved the consumption of a standardised liquid meal (a nutritional supplement containing the components of fat, carbohydrate, and protein, which make up a standard MMTT) within 15 minutes, and timed serial blood samples obtained for measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardized meal (with no additional food intake during this time).|Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised meal on Day -5 (Baseline) and Day 32|"Intent-to-treat (ITT) population included all participants who received any dose of study drug and analyzed according to their randomized treatment group. Here, N signifies only the participants with available data were analyzed for the outcome measure."|||Percent change in plasma glucose||90% Confidence Interval|Least Squares Mean
2527803|NCT03550066|Secondary|Diabetes Prevention Behavior: Intention|Behavioral intention to engage in, or seeking information about preventive health services|Up to 2 weeks|Analytic sample, after excluding participants with current diabetes or those already participating in a preventive program|||Participants|||Count of Participants
2527804|NCT03550066|Secondary|Diabetes Prevention Behavior: Information Seeking|Seeking information about prevention|Up to 2 weeks|Analytic sample, after excluding participants with current diabetes or those already participating in a preventive program|||Participants|||Count of Participants
2527806|NCT03549429|Secondary|Rate of Corneal Abrasions|Corneal abrasion is assessed in the recovery room|post-operation||||Participants|||Count of Participants
2527808|NCT03549429|Primary|Proportion of Participants With Eyelid Erythema|"The amount of erythema caused upon removal of the tape is the primary outcome of interest. Investigators will use the following 0-3 tape-associated skin index grading scale to grade eyelid erythema:~0- no erythema~mild erythema~moderate erythema~severe erythema The primary outcome will then be converted to a binary scale (0= no erythema, 1= erythema) for the purposes of analysis."|Standardized photos will be taken within 5 minutes of removing tape after surgery (surgery of any duration)|"Inclusion Criteria: Age ≥ 18, surgeries scheduled for anesthesia of any duration.~Exclusion Criteria: Any patient that does not consent, any patient who has pre-existing eyelid erythema or other eyelid trauma/piercings, any surgery on the head, brain, neck, teeth, mouth, eyes or face, surgery in the prone position, patients <18 years old"|||Participants|||Count of Participants
2527809|NCT03549338|Primary|Number of Participants With Adverse Events (AEs) by Nature, Severity, and Occurrence.|Measured From Baseline to End of Trial Participation, as Assessed by the Common Terminology Criteria for AEs (Version 5) (CTCAE v5). AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology and the severity of the toxicities will be graded according to the CTCAE v5, where applicable.|4 months|The first patient was randomized to Arm B prior to the trial termination date and crossed over to Sym004 at the EOC1. The second patient was randomized to Arm B after the trial termination date, but enrolled to Arm A per Sponsor decision.|||participants|||Number
2527810|NCT03549130|Primary|Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 14|Participants scored all the domains of NRQLQ using 7 points scale,0=Not troubled,1=hardly troubled at all,2=somewhat troubled,3=moderately troubled, 4=quite a bit troubled,5=very troubled,6=extremely troubled.Sleep problems (difficulty getting sleep,unable to get good night sleep/wake up during night, restless [tossing and turning],having to get up because stuffy nose or blow nose using score,scores range:Min-Max[0-24]),Sleep time problems(Nasal congestion or stuffy nose,sinus pressure or pain,runny nose,post-nasal drip[drainage down back of nose/throat],headache,scores range:0-30);Symptoms on waking in morning(Feel tired and unrefreshed,nasal congestion/stuffy nose,congestion in sinuses,takes time to clear nighttime drainage after waking up,scores range:0-24);practical problems(have to avoid symptom triggers(such as dust,cigarette smoke,strong smells, perfumes),rub nose/eyes,take medication,score range:0-18).Lower scores relative to baseline indicate improvement in rhinitis symptoms.|At Day 14|The ITT (N= 128) population included all participants who were randomized into the study and had had at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2527811|NCT03549130|Primary|Number of Participants Showing Improvement for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 7|Participants scored all the domains of NRQLQ using 7 points scale,0=Not troubled,1=hardly troubled at all,2=somewhat troubled,3=moderately troubled, 4=quite a bit troubled,5=very troubled,6=extremely troubled.Sleep problems (difficulty getting sleep,unable to get good night sleep/wake up during night, restless [tossing and turning],having to get up because stuffy nose or blow nose using score,scores range:Min-Max[0-24]),Sleep time problems(Nasal congestion or stuffy nose,sinus pressure or pain,runny nose,post-nasal drip[drainage down back of nose/throat],headache,scores range:0-30);Symptoms on waking in morning(Feel tired and unrefreshed,nasal congestion/stuffy nose,congestion in sinuses,takes time to clear nighttime drainage after waking up,scores range:0-24);practical problems(have to avoid symptom triggers(such as dust,cigarette smoke,strong smells, perfumes),rub nose/eyes,take medication,score range:0-18).Lower scores relative to baseline indicate improvement in rhinitis symptoms.|At Day 7|The ITT (N= 128) population included all participants who were randomized into the study and had had at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2527812|NCT03549130|Primary|Change From Baseline in Mean Average Score for All the Four Questions of Domain Symptoms on Waking in the Morning of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire at Day 14|Participants scored for domain Symptoms on waking in the morning of NRQLQ using 7 points scale: 0=not troubled, 1=hardly troubled at all, 2=somewhat troubled, 3= moderately troubled, 4=quite a bit troubled, 5=very troubled, 6=extremely troubled. Questionnaire for this domain included: Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear night time drainage after waking up. Lower scores indicate improvement in the rhinitis symptoms|At Baseline and Day 14|The ITT (N= 128) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.|||Score on Scale||95% Confidence Interval|Least Squares Mean
2527813|NCT03549130|Primary|Change From Baseline in Mean Average Score for All the Four Questions of Domain Symptoms on Waking in the Morning of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7|Participants scored for domain Symptoms on waking in the morning of NRQLQ using 7 points scale: 0=not troubled, 1=hardly troubled at all, 2=somewhat troubled, 3= moderately troubled, 4=quite a bit troubled, 5=very troubled, 6=extremely troubled. Questionnaire for this domain included: Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear night time drainage after waking up. Lower scores indicate improvement in the rhinitis symptoms|At Baseline and Day 7|The ITT (N= 128) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.|||Score on Scale||95% Confidence Interval|Least Squares Mean
2527827|NCT03547531|Primary|Gingival Condition at 1 Month|"The examination of gingival condition was using the Gingival Index by Silness and Loe. A score between 0 and 3 was given based on the criteria:~0= Normal gingiva.~Mild inflammation - slight change in color, slight edema. No bleeding on probing.~Moderate inflammation - redness, edema and glazing. Bleeding on probing.~Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding.~This scale examine each teeth in 4 surfaces (mesial, distal, buccal, lingual/palatal)."|one month after baseline data collection||||gingival index|number of teeth surfaces|Standard Deviation|Mean
2527828|NCT03547531|Primary|Plaque Level at 1 Month|"Plaque level is examined using Turesky Modification of Quigley-Hein Index. The scale is ranged from 0 to 5. 0 means no dental plaque existed on the tooth surface. 5 means all of the tooth surface is covered by dental plaque from the area that is closest to gingival to the occlusal area. The higher number of scores means worse. This index examines the buccal and lingual/palatal surfaces of the teeth (each teeth examined in 2 surfaces)."|one month after baseline data collection||||plaque index|Number of teeth surfaces|Standard Deviation|Mean
2527814|NCT03549130|Primary|Change From Baseline in Mean Average Score of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 14|Participants scored all the domains of NRQLQ using same 7 points scales where 0=Not troubled and 6=extremely troubled. Domains: Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]); Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0- 30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers (such as dust, cigarette smoke, strong smells and perfumes), need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms.|At Baseline and Day 14|The ITT (N= 128) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.|||Score On scale||95% Confidence Interval|Least Squares Mean
2527815|NCT03549130|Primary|Change From Baseline in Mean Average Score of Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain Problems (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 7|Participants scored all the domains of NRQLQ using same 7 points scales where 0=Not troubled and 6=extremely troubled. Domains: Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]); Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0- 30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers (such as dust, cigarette smoke, strong smells and perfumes), need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms.|At baseline and Day 7|The ITT (N= 128) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.|||Score on Scale||95% Confidence Interval|Least Squares Mean
2527816|NCT03549117|Secondary|Number of Participants Showing Improvement on Daily Dairy Questions at Day 1, 3, 7 and 14 at Night|"Participants were asked following daily diary VAS scale questions Q1 How easy it was to breathe through your nose, Q2 how stuffed their nose felt and Q3 How open their nose feels at this time.~Q1 was scored using 100 mm VAS scale where 0 = extremely difficult to breathe and 100 = extremely easy to breathe.~Q3 was scored using 100 mm VAS scale where 0=extremely blocked, 100=extremely open.~Q2 was scored using a scale where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms."|At Baseline, Day 1, 3, 7 and 14|The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2527817|NCT03549117|Secondary|Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q2) at Day 1, 3, 7 and 14 in Morning|Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip removal (Q2). The participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms.|At Baseline, Day 1, 3, 7 and 14|The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.|||Score on Scale||95% Confidence Interval|Least Squares Mean
2527818|NCT03549117|Secondary|Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q2) at Day 1, 3, 7 and 14 in Night|Questions regarding nasal strips were asked to participants and scores were noted on daily basis. Participants were asked how stuffed their nose felt before and after strip removal (Q2). The participants scored their responses on a scale of 0 to 3 where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms.|At Baseline, Day 1, 3, 7 and 14|The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.|||Score on Scale||95% Confidence Interval|Least Squares Mean
2527819|NCT03549117|Secondary|Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Morning|Participants were asked how easy it was to breathe through their nose [Q1], how open your nose feels at this time [Q3] after strip application at night. The participants scored their responses on a 100 mm VAS scale where For Q1: 0 = extremely difficult to breathe and 100 = extremely easy to breathe. For Q3: 0=extremely blocked, 100=extremely open.|At Baseline, Day 1, 3, 7 and 14|The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.|||Score on Scale||95% Confidence Interval|Least Squares Mean
2527820|NCT03549117|Secondary|Change From Baseline in Mean Score in Response to Daily Diary Visual Analogue Scale (VAS) Questions (Q1 and Q3) at Day 1, 3, 7 and 14 in Night|Participants were asked how easy it was to breathe through their nose [Q1], how open your nose feels at this time [Q3] after strip application at night. The participants scored their responses on a 100 mm VAS scale where For Q1: 0 = extremely difficult to breathe and 100 = extremely easy to breathe. For Q3: 0=extremely blocked, 100=extremely open.|At Baseline, Day 1, 3, 7 and 14|The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.|||Score on Scale||95% Confidence Interval|Least Squares Mean
2527829|NCT03547531|Primary|Baseline Gingival Condition|"The examination of gingival condition was using the Gingival Index by Silness and Loe. A score between 0 and 3 was given based on the criteria:~0= Normal gingiva.~Mild inflammation - slight change in color, slight edema. No bleeding on probing.~Moderate inflammation - redness, edema and glazing. Bleeding on probing.~Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding.~This scale examine each teeth in 4 surfaces (mesial, distal, buccal, lingual/palatal)."|Baseline||||gingival index|Number of teeth surfaces|Standard Deviation|Mean
2528004|NCT03535571|Secondary|Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-1 Alpha After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).|Measured by the Multi-Analyte ELISArray|Baseline (Day 0) to end-of-study (Day 128)|Intent to treat population|||pg/mL||Standard Deviation|Mean
2527821|NCT03549117|Primary|Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 14|Participants scored all the domains of NRQLQ using 7 points scale,0=Not troubled,1=hardly troubled at all,2=somewhat troubled,3=moderately troubled, 4=quite a bit troubled,5=very troubled,6=extremely troubled.Sleep problems (difficulty getting sleep,unable to get good night sleep/wake up during night, restless [tossing and turning],having to get up because stuffy nose or blow nose using score,scores range:Min-Max[0-24]),Sleep time problems(Nasal congestion or stuffy nose,sinus pressure or pain,runny nose,post-nasal drip[drainage down back of nose/throat],headache,scores range:0-30);Symptoms on waking in morning(Feel tired and unrefreshed,nasal congestion/stuffy nose,congestion in sinuses,takes time to clear nighttime drainage after waking up,scores range:0-24);practical problems(have to avoid symptom triggers[such as dust,cigarette smoke,strong smells,perfumes],rub nose/eyes,take medication,score range:0-18).Lower scores relative to baseline indicate improvement in rhinitis symptoms.|At Day 14|The ITT (N= 140) population included all participants who were randomized into the study and hadat least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2527822|NCT03549117|Primary|Number of Participants Showing Improvement for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) of Nocturnal Rhino Conjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7|Participants scored all the domains of NRQLQ using 7 points scale,0=Not troubled,1=hardly troubled at all,2=somewhat troubled,3=moderately troubled, 4=quite a bit troubled,5=very troubled,6=extremely troubled.Sleep problems (difficulty getting sleep,unable to get good night sleep/wake up during night, restless [tossing and turning],having to get up because stuffy nose or blow nose using score,scores range:Min-Max[0-24]),Sleep time problems(Nasal congestion or stuffy nose,sinus pressure or pain,runny nose,post-nasal drip[drainage down back of nose/throat],headache,scores range:0-30);Symptoms on waking in morning(Feel tired and unrefreshed,nasal congestion/stuffy nose,congestion in sinuses,takes time to clear nighttime drainage after waking up,scores range:0-24);practical problems(have to avoid symptom triggers[such as dust,cigarette smoke,strong smells,perfumes],rub nose/eyes,take medication,score range:0-18).Lower scores relative to baseline indicate improvement in rhinitis symptoms.|At Day 7|The ITT (N= 140) population included all participants who were randomized into the study and had had at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2527823|NCT03549117|Primary|Change From Baseline in Mean Score of Four Questions on the Domain Symptoms on Waking in the Morning in Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 14|Participants scored for domain Symptoms on waking in the morning of NRQLQ using 7 points scale: 0=not troubled, 1=hardly troubled at all, 2=somewhat troubled, 3= moderately troubled, 4=quite a bit troubled, 5=very troubled, 6=extremely troubled. Questionnaire for this domain included: Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up. Lower scores indicate improvement in the rhinitis symptoms|At Baseline and Day 14|The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.|||Score on Scale||95% Confidence Interval|Least Squares Mean
2527824|NCT03549117|Primary|Change From Baseline in Mean Score of Four Questions on the Domain Symptoms on Waking in the Morning in Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) at Day 7|Participants scored for domain Symptoms on waking in the morning of NRQLQ using 7 points scale: 0=not troubled, 1=hardly troubled at all, 2=somewhat troubled, 3=moderately troubled, 4=quite a bit troubled, 5=very troubled, 6=extremely troubled. Questionnaire for this domain included: Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up. Lower scores indicate improvement in the rhinitis symptoms|At Baseline and Day 7|The ITT (N=140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.|||Score on Scale||95% Confidence Interval|Least Squares Mean
2527825|NCT03549117|Primary|Change From Baseline in Mean Total Score of the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 14|Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0- 30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers (such as dust, cigarette smoke, strong smells and perfumes), need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms.|At Baseline and Day 14|The ITT (N= 140) population included all participants who were randomized into the study and had at least one post-baseline efficacy assessment.|||Score on Scale||95% Confidence Interval|Least Squares Mean
2527826|NCT03549117|Primary|Change From Baseline in Mean Total Score of the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) for Each Domain (Sleep, Sleep Time, Symptoms on Waking in the Morning, and Practical Problems) at Day 7|Participants scored all the domains of NRQLQ using same 7 points scale where 0=Not troubled and 6=extremely troubled. Sleep problems (difficulty getting sleep, unable to get a good night sleep or wake up during the night, restless [tossing and turning] and having to get up because stuffy nose or to blow nose using the score, scores range: Min-Max [0-24]), Sleep time problems (Nasal congestion or stuffy nose, sinus pressure or pain, runny nose, post-nasal drip [drainage down back of nose/throat], and headache, scores range: 0- 30); Symptoms on waking in the morning (Feel tired and unrefreshed, nasal congestion or stuffy nose, congestion in sinuses, takes time to clear nighttime drainage after waking up, scores range:0-24); practical problems (have to avoid symptom triggers (such as dust, cigarette smoke, strong smells and perfumes), need to rub nose or eyes, and have to take medication, scores range: 0-18). Lower scores indicate improvement in the rhinitis symptoms.|At Baseline and Day 7|The Intent to treat (ITT) (n=140) population included all the participants who were randomized into the study and had at least one post-baseline efficacy assessment.|||Score on Scale||95% Confidence Interval|Least Squares Mean
2536684|NCT03159299|Secondary|Physical Activity|Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer.|Baseline|||||||
2527830|NCT03547531|Primary|Baseline Plaque Level|"Plaque level is examined using Turesky Modification of Quigley-Hein Index. The scale is ranged from 0 to 5. 0 means no dental plaque existed on the tooth surface. 5 means all of the tooth surface is covered by dental plaque from the area that is closest to gingival to the occlusal area. The higher number of scores means worse. This index examines the buccal and lingual/palatal surfaces of the teeth (each teeth examined in 2 surfaces)."|Baseline||||plaque index|Number of teeth surfaces|Standard Deviation|Mean
2527831|NCT03547154|Secondary|Number of Participants With Overall Survival|Participants were followed for survival; those who did not achieve a major cytogenetic response were discontinued from the study. For participants who completed 1 year of study treatment and continued to Year 2 and beyond, survival and disease progression every 3 months were assessed, and serious adverse events (SAEs) were reported. Participants were followed until resolution of any drug-related nonserious adverse event, and any SAE occurring while on the study or within 30 days of last dose of study drug. Participant death during survival follow-up was reported to the drug safety unit of the Sponsor. Each participant (whether discontinued or still on treatment) was followed every 3 months for survival and disease progression information. Overall survival was analyzed using the log-rank statistic, and the hazard ratio (HR) and 95% confidence interval (CI) for the HR were obtained using Cox's proportional hazards model.|Up to 2 years (24 months), and beyond|All randomized participants who received at least one dose of assigned treatment|||Participants|||Count of Participants
2527832|NCT03547154|Secondary|Number of Participants With Hematologic Responses to PEG Intron and Intron A at 6 Months|Hematologic response at 6 months was assessed, while the hematologic response was measured at 3, 6, 9 and 12 months during the first year of study treatment. To be considered a hematologic responder a participant must have met all of the following criteria for a minimum of 28 days: WBC count <10,000/μL; platelet count <450,000/L; normal differential count in peripheral blood (manual differential count); no palpable spleen. Participants achieving a complete hematologic response at 3 months had the cytogenetic response evaluated at 3 months as well. Participants who achieved a complete hematologic response by 6 months continued treatment for another 6 months. Participants who failed to achieve a complete hematologic response after 6 months of treatment were considered treatment failures, and further treatment for this group was at the discretion of the treating physician. Participants may have continued to receive their assigned study medication for an additional 6 months.|6 months|All randomized participants who received at least one dose of assigned treatment|||Participants|||Count of Participants
2527833|NCT03547154|Secondary|Number of Participants With Cytogenetic Response (CR) to PEG Intron and Intron A at 6 Months|Cytogenetic response (CR) at 6 months, as at 12 months, was defined by the degree of suppression of Philadelphia chromosome (Ph^1) achieved during study treatment. The determination of CR at 6 months was based on cytogenetic analysis of bone marrow aspirate samples. The CR criteria were based on the percentage (%) of PH^1-positive cells during study treatment. Protocol-defined CR criteria were Complete (0%), Partial (1-34%), Minor (35-90%), or No Response (>90%). Data for the analysis population was based on the intent-to-treat principle. Participants who were treatment failures at 6 months were considered cytogenetic non-responders. Recording of CR was independent of hematologic responses.|6 months|All randomized participants who received at least one dose of assigned treatment|||Participants|||Count of Participants
2527834|NCT03547154|Primary|Number of Participants With Cytogenetic Responses to PEG Intron and INTRON A at 12 Months|Cytogenetic response (CR) was defined by the degree of suppression of Philadelphia chromosome (Ph^1) achieved during study treatment. For all participants continuing treatment after study conclusion, cytogenetic assessments were conducted locally as per standard of care. Determination of CR at 12 months were based on cytogenetic analysis of bone marrow aspirate samples. The CR criteria were based on the percentage (%) of PH^1-positive cells during study treatment. Protocol-defined CR criteria were Complete Response (0%), Partial Response (1-34%), Minor Response (35-90%), or No Response (>90%). Data for the analysis population was based on the intent-to-treat principle. Participants who were treatment failures at 6 months were considered cytogenetic non-responders. Recording of CR was independent of hematologic responses.|Up to 12 months|All randomized participants analyzed on an intent-to-treat basis.|||Participants|||Count of Participants
2527835|NCT03546842|Secondary|Geometric Mean Titers of Antibodies to HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7|Anti-HPV Type 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibodies are measured using a Competitive Luminex Immunoassay. Titers are reported in mMU/mL.|4 weeks postdose 3 (Month 7)|All allocated participants who were seronegative to the appropriate HPV type at Day 1, received all 3 vaccinations with the correct dose within acceptable day ranges, provided a serum sample within 21 to 49 days postdose 3, and had no protocol deviations that could interfere with the evaluation of participant’s immune response to 9vHPV vaccination.|||mMU/mL||95% Confidence Interval|Geometric Mean
2527836|NCT03546842|Secondary|Geometric Mean Titers of Serotype-specific Antibodies: Predose Day 1|Anti-HPV Type 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibodies are measured using a Competitive Luminex Immunoassay. Titers are reported in milli Merck units/mL (mMU/mL).|Day 1 (predose)|All allocated participants who were seronegative to the appropriate HPV type at Day 1, received all 3 vaccinations with the correct dose within acceptable day ranges, provided a serum sample within 21 to 49 days postdose 3, and had no protocol deviations that could interfere with the evaluation of participant’s immune response to 9vHPV vaccination.|||mMU/mL||95% Confidence Interval|Geometric Mean
2527837|NCT03546842|Secondary|Percentage of Participants With a Vaccine-related Serious Adverse Event|A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants that experience at least one SAE that was reported as at least possibly related to the study vaccine was summarized.|Up to 4 weeks postdose 3 (Month 7)|All participants that received at least 1 vaccination with 9vHPV vaccine and provided safety data at any time during the study.|||Percentage of Participants|||Number
2527854|NCT03546270|Secondary|Cardiorespiratory Endurance (Volume of Maximal Oxygen Consumption)|via Cornell Modified Bruce treadmill volume of oxygen consumption maximum (VO2max) test|20-weeks||||mL/kg/min||Standard Deviation|Mean
2527855|NCT03546270|Secondary|Muscular Strength|via Hand Grip Dynamometer|20-weeks||||kilograms (kg)||Standard Deviation|Mean
2527856|NCT03546270|Secondary|Pressure Wave Reflection|via Augmentation Index|20-weeks||||% of wave reflection||Standard Deviation|Mean
2527838|NCT03546842|Secondary|Percentage of Participants With a Solicited Systemic Adverse Event|An AE was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study vaccine. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study vaccine or protocol-specified procedure was also an AE. The only solicited systemic AE was in response to results of daily oral temperature assessments. The participant or the parent/guardian of the participant will be asked to record the participant's oral temperature in the evening after each study vaccination and daily for 4 days after each study vaccination on VRC. The percentage of participants that had an AE due to an elevated oral temperature [(≥ 37.8 °C (100.0 °F)] was summarized.|Up to 5 days after any vaccination|All participants that received at least 1 vaccination with 9vHPV vaccine and provided safety data at any time during the study.|||Percentage of Participants|||Number
2527839|NCT03546842|Secondary|Percentage of Participants With a Solicited Injection-site Adverse Event|An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study vaccine. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study vaccine or protocol-specified procedure was also an AE. The participant or the parent/guardian of the participant were to record the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 5 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.|Up to 5 days after any vaccination|All participants that received at least 1 vaccination with 9vHPV vaccine and provided safety data at any time during the study.|||Percentage of Participants||95% Confidence Interval|Number
2527840|NCT03546842|Primary|Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7|Seroconversion was defined as a participant who was anti-HPV seronegative at Day 1 and became seropositive at 4 weeks postdose 3 (Month 7). Anti-HPV antibodies were measured using a Competitive Luminex Immunoassay.|4 weeks postdose 3 (Month 7)|All allocated participants who were seronegative to the appropriate HPV type at Day 1, received all 3 vaccinations with the correct dose within acceptable day ranges, provided a serum sample within 21 to 49 days postdose 3, and had no protocol deviations that could interfere with the evaluation of participant’s immune response to 9vHPV vaccination.|||Percentage of Participants||95% Confidence Interval|Number
2527841|NCT03546621|Secondary|Change in HBV DNA Levels at Week 24 and Week 48 Compared to Baseline|Change in hepatitis B virus (HBV) DNA levels at Week 24 and Week 48 compared to baseline.|24 and 48 weeks|mITT|||IU/mL||Standard Deviation|Mean
2527842|NCT03546621|Secondary|Change in Hepatitis B Surface Antigen|Changes in hepatitis B surface antigen (HBsAg) (defined as decline in HBsAg levels, disappearance of HBsAg and HBsAg seroconversion to anti-HBsAg) at week 24 and week 48 compared to baseline|24 and 48 weeks|mITT|||IU/mL||Standard Deviation|Mean
2527843|NCT03546621|Secondary|Changes (Absence of Increase) in Fibrosis Marker|Changes (absence of increase) in fibrosis marker: serum alpha-2-macroglobulin at Week 24 and Week 48 compared to baseline|24 and 48 weeks|mITT|||g/L||Standard Deviation|Mean
2527844|NCT03546621|Secondary|Lack of Fibrosis Progression. Change in Liver Stiffness Results.|Lack of fibrosis progression based on transient elastometry (Fibroscan) at Week 24 compared to baseline.|24 weeks||||kPa||Standard Deviation|Mean
2527845|NCT03546621|Secondary|Changes in ALT Values|Changes in ALT values at Week 24 and Week 48 compared to baseline.|24 and 48 weeks|mITT|||U/L||Standard Deviation|Mean
2527846|NCT03546621|Secondary|Combined Response: HDV RNA Response and Normal ALT at Treatment Week 24|Combined response: HDV RNA negativation or ≥2 log decline and normal ALT at treatment week 24|24 weeks|mITT|||Participants|||Count of Participants
2527847|NCT03546621|Secondary|Durability of HDV RNA Response|Durability of HDV RNA response to 24 weeks post treatment|48 weeks|mITT|||Participants|||Count of Participants
2527848|NCT03546621|Primary|HDV RNA Response at Week 24|HDV RNA negativation or decrease by ≥2 log10 from baseline to Week 24|24 weeks|mITT|||Participants|||Count of Participants
2527849|NCT03546491|Secondary|Overall Baseline Mean Digital Plaque Imaging|Total percent dental plaque area|Baseline||||percentage of plaque area||Standard Error|Mean
2527850|NCT03546491|Secondary|Digital Plaque Imaging|Total percent dental plaque area|Day 4||||percentage of plaque area||Standard Error|Mean
2527851|NCT03546491|Secondary|Mean Turesky Modified Quigley-Hein Index at Baseline|The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth.|Baseline||||score on a scale||Standard Error|Mean
2527852|NCT03546491|Primary|Mean Turesky Modified Quigley-Hein Index at Day 4|The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth.|Day 4||||score on a scale||Standard Error|Mean
2527853|NCT03546270|Secondary|Diastolic Blood Pressure||20 weeks||||millimeters of mercury (mmHg)||Standard Deviation|Mean
2527859|NCT03546192|Primary|Number of Participants Reporting Solicited Reactions Listed in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance|Solicited reactions listed in the CHMP note for guidance included: injection site induration >= 50 mm for at least 4 consecutive days , injection site ecchymosis, temperature > 38.0°C for at least one day, malaise, and shivering.|Within 3 days after vaccination|Analysis was performed on the safety analysis set.|||Participants|||Count of Participants
2527860|NCT03546192|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions|A solicited reaction is an adverse event (AE) that is pre-listed in the electronic case report form (eCRF) and considered to be related to vaccination. Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity), erythema, swelling, induration, and ecchymosis (Grade 1: >=25 mm to <= 50 mm, Grade 2: >=51 to <=100 mm, Grade 3: > 100 mm). Solicited systemic reactions: Fever (Grade 1: >=38.0 degree Celsius (°C) to <=38.4°C, Grade 2: >=38.5°C to <=38.9 °C, Grade 3: >= 39°C), headache, malaise, myalgia, and shivering (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity). Number of participants with any of the Grade 1, 2 or 3 solicited injection-site and systemic reactions and Grade 3 solicited injection-site and systemic reactions were reported.|Within 7 days after vaccination|Analysis was performed on the safety analysis set.|||Participants|||Count of Participants
2527861|NCT03546192|Primary|Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens|Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) and a post-vaccination titer >= 40 (1/dil). Significant increase was defined as a pre-vaccination titer >= 10 (1/dil) and >= 4-fold increase in post vaccination titer. Number of participants with seroconversion or significant increase to Influenza vaccine antigens were reported.|21 days post-vaccination|Analysis was performed on the Immunogenicity analysis set.|||Participants|||Count of Participants
2527862|NCT03546192|Primary|Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies|Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Geometric mean titer ratio was calculated as geometric mean titer at Day 21 divided by geometric mean titer at day 0 for each specified group.|Day 0 (pre-vaccination), Day 21 (Post-vaccination)|Analysis was performed on the Immunogenicity analysis set.|||ratio||95% Confidence Interval|Number
2527863|NCT03546192|Primary|Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)|Anti-influenza antibodies were measured using a HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage.|Day 0 (pre-vaccination) and Day 21 (post-vaccination)|Analysis was performed on the Immunogenicity analysis set.|||Titers (1/dilutions [dil])||95% Confidence Interval|Geometric Mean
2527864|NCT03546192|Primary|Number of Participants With Seroprotection to Influenza Vaccine Antigens at Day 0 (Pre-vaccination) and Day 21 (Post-vaccination)|Anti-influenza antibodies were measured using hemagglutination-inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. Seroprotection was defined as an antibody titer >=40 (1/dilution [dil]) at pre-vaccination and post-vaccination.|Day 0 (pre-vaccination) and Day 21 (post-vaccination)|Immunogenicity analysis set included all participants who received one dose of study medication, had pre-and post-vaccination titers available and had not received vaccination against influenza in the previous 12 months if administered in the context of a clinical trial or a flu vaccination campaign.|||Participants|||Count of Participants
2527865|NCT03545984|Primary|Composite Staff Evaluation Score (Anesthetist's Nontechnical Skills Global Rating Scale)|"The composite score is a continuous outcome varies between 0 and 16; 0 being the worst possible score and 16 the best possible score. Composite score received by a resident from a supervising anesthesiologist; validated scoring system based on Anesthetist's Nontechnical Skills (ANTS) Global Rating Scale. The hierarchical ANTS scoring system consists at the highest level of four basic skill categories, namely task management, team working, situation awareness, and decision making. These skill categories are further divided up into 16 skill elements and then each element is scored 0-1 and then all elements are summed for a total score of 0-16. The decision to report outcome in categories (Score 14-16, Score 11-13, Score 10 and below) instead of numeric contentious outcome was data driven and not represent any specified performance categories(i.e., best performance, good performance, poor performance)."|just after first CSF drainage catheter insertion and during 4-week vascular rotation; at least by the end of 4-week rotation||||Participants|||Count of Participants
2527866|NCT03545893|Primary|Maximum Pain Score|"Numerical Rating Scale (NRS) pain score (scale range 0-10, with a 0 meaning no pain and 10 meaning the worst possible pain)"|24 hours||||score on a scale||Standard Deviation|Mean
2527867|NCT03545412|Secondary|Number of Participants With Overall Aesthetic Improvement as Assessed by the SGAIS at Day 180|Overall aesthetic improvement was assessed by participants using GAIS. At 180 days post-treatment, each participant completed a GAIS, known as SGAIS. The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported.|Baseline, Day 180|All participants who were treated with Ultherapy were included for the assessment.|||Participants|||Count of Participants
2527868|NCT03545412|Secondary|Number of Participants With Overall Aesthetic Improvement as Assessed by the Physician Global Aesthetic Improvement Scale (PGAIS) at Day 180|Overall aesthetic improvement was assessed by the principal investigator using the GAIS. At 180 days post-treatment, each principal investigator completed a GAIS, known as PGAIS .The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported.|Baseline, Day 180|All participants who were treated with Ultherapy were included for the assessment.|||Participants|||Count of Participants
2527869|NCT03545412|Secondary|Number of Participants With Improvement in Patient Satisfaction Questionnaire at Day 90|Participants completed a PSQ at the 90-day visit. The PSQ has 5 satisfaction categories ranging from 'very dissatisfied' to 'very satisfied'.|Day 90|All participants who were treated with Ultherapy were included for the assessment.|||Participants|||Count of Participants
2528270|NCT03519919|Secondary|Overall Preference Between Study and Habitual Contact Lenses for Lifestyle|Preference of contact lens for the whole range of tasks (Prefer strongly, Prefer slightly, No preference, Prefer study lenses slightly, Prefer study lenses strongly)|3 weeks||||percentage of participants|||Number
2527870|NCT03545412|Secondary|Number of Participants With Overall Aesthetic Improvement as Assessed by the Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90|Overall aesthetic improvement was assessed by participants using global aesthetic improvement scale (GAIS). At 90 days post-treatment, each participant completed a GAIS, known as SGAIS.The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported.|Baseline, Day 90|All participants who were treated with Ultherapy were included for the assessment.|||Participants|||Count of Participants
2527871|NCT03545412|Secondary|Number of Participants With Overall Aesthetic Improvement as Assessed by the Principal Investigator Using the Global Aesthetic Improvement Scale (PGAIS) at Day 90|Overall aesthetic improvement was assessed by the principal investigator using global aesthetic improvement scale (GAIS). At 90 days post-treatment, each principal investigator completed a GAIS, known as physician global aesthetic improvement scale (PGAIS) .The GAIS is 5-point scale (1-5), where: 1(very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse). Only participants who had any improvement were reported.|Baseline, Day 90|All participants who were treated with Ultherapy were included for the assessment.|||Participants|||Count of Participants
2527872|NCT03545412|Primary|Number of Participants With Lift in Brow Region at Day 90|Lift improvement as measured by quantitative analysis was considered minimum 0.5 millimeter (mm) Day 90 photograph compared to baseline photograph. The quantitative analysis was calculated by using five evenly spaced points along the natural outline of each participant's brow. Brow height was calculated using the sum and average of the five calculations in each brow area.|Baseline, Day 90|All participants who were treated with Ultherapy were included for the assessment. The analysis included all participants who had the measurement available for brows. One participant excluded due to inability to measure brow.|||Participants|||Count of Participants
2527873|NCT03545412|Primary|Number of Participants With Improvement in Skin Laxity in Submental Region and Neck at Day 90|Lift improvement as measured by quantitative analysis was considered greater than or equal to (>=) 20.0 square millimeter (mm^2) of the submental area Day 90 photograph compared to baseline photograph. The quantitative analysis was calculated by using five evenly spaced points on the neck. Area was calculated in between each of the 5 points and then sum of the five calculations was the total area of the region of interest.|Baseline, Day 90|All participants enrolled and treated with Ultherapy. Only participants categorized as good candidates for photographs were included in the analysis. Good candidates for photographs was defined as those participants who had sufficient distance between the menton and neck, and enough lower face volume to allow for accurate measurements.|||Participants|||Count of Participants
2527874|NCT03544879|Secondary|Participant Satisfaction|Participant Satisfaction with participation was rated on a 0-10 scale (10 = most positive) usingquestions about enjoyment with and benefits of participation.|10 weeks||||units on a scale||Standard Deviation|Mean
2527875|NCT03544879|Secondary|Pittsburgh Sleep Quality Index (PSQI)|Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI). The measure has 21 items and scores can range from 0-21 with higher scores indicating lower sleep quality.|Change from baseline to 10 weeks||||units on a scale||Standard Deviation|Mean
2527876|NCT03544879|Secondary|Brief Anxiety Inventory (BAI)|Anxiety was assessed using the Brief Anxiety Inventory (BAI). The self-administered BAI consists of 21 items, and has well-established reliability(29) and validity. Scores can range from 0-63 with higher scores indicating greater levels of anxiety.|Change from baseline to 10 weeks||||units on a scale||Standard Deviation|Mean
2527877|NCT03544879|Secondary|Center for Epidemiologic Studies Short Depression Scale (CES-D 10)|Depression was assessed using the 10-item Center for Epidemiologic Studies Short Depression Scale (CES-D 10). Scores can range from 0-30 with higher scores indicating higher levels of depressive symptoms.|Change from baseline to 10 weeks||||units on a scale||Standard Deviation|Mean
2527878|NCT03544879|Secondary|SF-36|The SF-36 has 36 items and takes about 8-10 minutes to complete. The scale measure domains of health-related quality of life and two summary scores corresponding to physical and mental health. Scores for each subscale are standardized and range from 0-100 with higher scores representing better quality of life.|Change from baseline to 10 weeks||||units on a scale||Standard Deviation|Mean
2527879|NCT03544879|Secondary|Grip Strength|Grip Strength was assessed with an adjustable, hydraulic grip strength dynamometer.(26) The measure uses the average of two trials for both the left and right hand.|Change from baseline to 10 weeks|2 participants in each group completed written self-report measures but not physical assessments at 10 weeks (follow-up).|||pounds of pressure||Standard Deviation|Mean
2527880|NCT03544879|Secondary|Limits of Stability (LOS)|"The LOS is used to define a participant's cone of stability and measures components of balance and stability related to reaction time, directional control, and the ability to make corrective movements. Movement velocity indicates the speed of center of gravity (COG) displacement in degrees per second, with higher values signifying quicker movement through the region of stability."|Change from baseline to 10 weeks|2 participants in each group completed written self-report measures but not physical assessments at 10 weeks (follow-up).|||degrees per second||Standard Deviation|Mean
2527881|NCT03544879|Secondary|Sensory Organization Test (SOT) Vestibular|The SOT assesses the sensory components of balance by measuring postural sway balance in different conditions as a useful predictor of fall risk. The ratio score indicates ability to maintain balance in the presence of inaccurate visual cues. Scores are represented as a percentage from 0 to 100, with scores closer to 100 indicating greater stability.|Change from baseline to 10 weeks|2 participants in each group completed written self-report measures but not physical assessments at 10 weeks (follow-up).|||percent stability maintained||Standard Deviation|Mean
2527882|NCT03544879|Secondary|Rhythmic Weight Shift (RWS)|Rhythmic Weight Shift (RWS) measures participant ability to rhythmically move between two targets at different speeds. The On-Axis Velocity is the speed of the COG displacement in degrees per second during on-axis movement between the test target(s), with greater velocity indicating faster movement through the region of stability|Change from baseline to 10 weeks|2 participants in each group completed written self-report measures but not physical assessments at 10 weeks (follow-up).|||degrees per second||Standard Deviation|Mean
2528000|NCT03535571|Secondary|Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-11 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).|Measured by the Multi-Analyte ELISArray.|Baseline (Day 0) to end-of-study (Day 128)|This measure was not included in the Multi-Analyte ELISArray analysis, therefore there is no data to report.||||||
2527883|NCT03544879|Secondary|Step Up and Over (SUO)|The Step Up and Over (SUO) test measures gait quality as it may influence negotiating curbs, climbing or descending stairs, and predicting fall risk. The lift index quantifies the maximum lifting force exerted by the leading leg expressed as a percentage of the individual's weight as measured by the force plate, with scores closer to 100% demonstrating greater force.|Change from baseline to 10 weeks|2 participants in each group completed written self-report measures but not physical assessments at 10 weeks (follow-up).|||percent of weight||Standard Deviation|Mean
2527884|NCT03544879|Primary|Short Physical Performance Battery (SPPB)|The Short Physical Performance Battery (SPPB) measures time to walk four meters; time to five chair stands; and balance, with higher scores being associated with decreased disability and mortality. These 3 components are rated on a scale from 0-4 and they are summed to provide a total SPPB score ranging from 0-12.|Change in SPPB from baseline to 10 weeks||||units on a scale||Standard Deviation|Mean
2527885|NCT03544307|Secondary|Leg Strength||12-weeks||||kilograms (kg)||Standard Deviation|Mean
2527886|NCT03544307|Secondary|Diastolic Blood Pressure||12-weeks||||mmHg||Standard Deviation|Mean
2527887|NCT03544307|Secondary|Hand Grip Strength||12-weeks||||kilograms (kg)||Standard Deviation|Mean
2527888|NCT03544307|Secondary|Systolic Blood Pressure||12-weeks||||mmHg||Standard Deviation|Mean
2527889|NCT03544307|Secondary|Arterial Stiffness|Pulse Wave Velocity|12-weeks||||m/s||Standard Deviation|Mean
2527890|NCT03544307|Primary|Blood Norepinephrine Levels||12-weeks||||pg/mL||Standard Deviation|Mean
2527891|NCT03544307|Primary|Blood Epinephrine Levels||12-weeks||||pg/mL||Standard Deviation|Mean
2527892|NCT03544216|Primary|Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score|"After wearing each lens type (single vision and multifocal) for 2 weeks, subjects will complete the CLDEQ-8, a survey that assesses symptoms of contact lens discomfort, to reports their symptoms of discomfort with each lens type. CLDEQ-8 scores with the multifocal will be compared to CLDEQ-8 scores of the single vision lens and the subjects' habitual contact lenses to determine if the multifocal improved comfort.~Min-Max CLDEQ-8 range: 0-37 points Higher point values indicate more/worse symptoms"|Baseline and after 2 weeks of contact lens wear with each study lens (single vision and multifocal)||||scores on a scale||Standard Deviation|Mean
2527893|NCT03543137|Primary|Assessment of Bioequivalence of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Maximum Observed Plasma Nicotine Concentration (Cmax)|Blood samples were collected at designated timepoints. Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring Cmax that was taken directly from bioanalytical data. Geometric Coefficient of variation was provided as percentage. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (Cmax) as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the GMR between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.|0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period|Analysis performed on PKAS1, that included all randomized participants who completed both periods, had no major protocol deviations concerning pharmacokinetics, excluding those with baseline nicotine concentration > 5% of individual Cmax for either period.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2527894|NCT03543137|Secondary|Number of Participants With Clinically Significant Change in Laboratory Test Values|Haematological, biochemistry and urinalysis parameters were analyzed. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter.|From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)|Safety population was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Count of Participants
2527895|NCT03543137|Secondary|Comparison of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Apparent Elimination Rate Constant for Plasma Nicotine (Kel)|kel was defined as apparent elimination rate constant for plasma nicotine that was calculated as negative of the slope of a linear regression of the log(concentration)- time for all concentrations > lower limit of quantification.|0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period|Analysis performed on PKAS1, that included all randomized participants who completed both periods, had no major protocol deviations concerning pharmacokinetics, excluding those with baseline nicotine concentration > 5% of individual Cmax for either period. Here, number analyzed indicates participants with available data for this outcome measure.|||fraction per hour||Full Range|Mean
2527896|NCT03543137|Secondary|Comparison of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Apparent Elimination Half-Life (t1/2)|t1/2 was defined as apparent elimination half-life that was calculated as t1/2 = ln(2) / Kel, where Kel= elimination rate constant.|0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period|Analysis performed on PKAS1, that included all randomized participants who completed both periods, had no major protocol deviations concerning pharmacokinetics, excluding those with baseline nicotine concentration > 5% of individual Cmax for either period. Here, number analyzed indicates participants with available data for this outcome measure.|||hour||Full Range|Mean
2527897|NCT03543137|Secondary|Comparison of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Time of Maximum Plasma Nicotine Concentration (Tmax)|Tmax was defined as the time to maximum plasma nicotine concentration. If the maximum value occurred at more than one time point, Tmax was defined as the first time point with this value.|0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period|Analysis performed on PKAS1, that included all randomized participants who completed both periods, had no major protocol deviations concerning pharmacokinetics, excluding those with baseline nicotine concentration > 5% of individual Cmax for either period.|||hour||Inter-Quartile Range|Median
2527950|NCT03537404|Primary|AUCtau of Tenofovir|Area Under the Concentration-time curve during a dosing interval τ at steady state of Tenofovir at Day 5 of treatment B and C of Part 1 of the study|Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 18 and 24 hrs post-dose on Day 5 of treatment B and C (Part 1)|All subjects randomized to study treatment and received at least one dose of study drug.|||ng*h/ml||90% Confidence Interval|Geometric Mean
2527898|NCT03543137|Primary|Assessment of Bioequivalence of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Area Under the Plasma Concentration Versus Time Curve Calculated From Time Zero to Infinity (AUC [(0-inf])|Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring AUC(0-inf). AUC(0-inf) = AUC0-t + (Clast/kel), where, AUC0-t= area under the plasma concentration versus time curve from time zero to time t; Clast= last observed/measured plasma concentration and kel= elimination rate constant. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (AUC[0-inf]), as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the GMR between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.|0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period|Analysis performed on PKAS1, that included all randomized participants who completed both periods, had no major protocol deviations concerning pharmacokinetics, excluding those with baseline nicotine concentration > 5% of individual Cmax for either period. Here, number analyzed indicates participants with available data for this outcome measure.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2527899|NCT03543137|Primary|Assessment of Bioequivalence of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t (AUC [0-t])|Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring AUC(0-t), where t= time of the last measurable plasma concentration. AUC(0-t) was calculated using the linear trapezoidal with linear interpolation method. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (AUC0-t), as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the geometric mean ratios (GMR) between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.|0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period|Pharmacokinetic analysis set1 (PKAS1) included all randomized participants who completed both periods, had no major protocol deviations concerning pharmacokinetics, excluding those with baseline nicotine concentration greater than (>) 5 percent (%) of individual highest observed plasma nicotine concentration (Cmax) for either period.|||nanograms*hours per milliliter(ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2527900|NCT03541044|Secondary|Number of Participants With Clinically Significant Change in Laboratory Test Values|Haematological, biochemistry and urinalysis parameters were analyzed. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter.|From signing of the informed consent form until 5 days after last administration of study drug (up to Day 13)|Safety population was defined as all randomized participants who received at least one dose of study medication.|||Participants|||Count of Participants
2527901|NCT03541044|Secondary|Comparison of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Apparent Elimination Rate Constant for Plasma Nicotine (Kel)|kel was defined as apparent elimination rate constant for plasma nicotine that was calculated as negative of the slope of a linear regression of the log(concentration)- time for all concentrations > lower limit of quantification.|0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period|Analysis performed on PKAS1, that included all randomized participants who completed both periods, had no major protocol deviations concerning pharmacokinetics, excluding those with baseline nicotine concentration > 5% of individual Cmax for either period. Here, number analyzed indicates participants with available data for this outcome measure.|||fraction per hour||Full Range|Mean
2527902|NCT03541044|Secondary|Comparison of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Apparent Elimination Half-Life (t1/2)|t1/2 was defined as apparent elimination half-life that was calculated as t1/2 = ln(2) / Kel, where Kel= elimination rate constant.|0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period|Analysis performed on PKAS1, that included all randomized participants who completed both periods, had no major protocol deviations concerning pharmacokinetics, excluding those with baseline nicotine concentration > 5% of individual Cmax for either period. Here, number analyzed indicates participants with available data for this outcome measure.|||hour||Full Range|Mean
2527903|NCT03541044|Secondary|Comparison of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Time of Maximum Plasma Nicotine Concentration (Tmax)|Tmax was defined as the time to maximum plasma nicotine concentration. If the maximum value occurred at more than one time point, Tmax was defined as the first time point with this value.|0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period|Analysis performed on PKAS1, that included all randomized participants who completed both periods, had no major protocol deviations concerning pharmacokinetics, excluding those with baseline nicotine concentration > 5% of individual Cmax for either period.|||hour||Inter-Quartile Range|Median
2527904|NCT03541044|Primary|Assessment of Bioequivalence of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Maximum Observed Plasma Nicotine Concentration (Cmax)|Blood samples were collected at designated timepoints. Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring Cmax that was taken directly from bioanalytical data. Geometric Coefficient of variation was provided as percentage. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (Cmax) as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the GMR between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.|0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period|Analysis performed on PKAS1, that included all randomized participants who completed both periods, had no major protocol deviations concerning pharmacokinetics, excluding those with baseline nicotine concentration > 5% of individual Cmax for either period.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2528723|NCT03491553|Secondary|Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8||Baseline, Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2527905|NCT03541044|Primary|Assessment of Bioequivalence of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Area Under the Plasma Concentration Versus Time Curve Calculated From Time Zero to Infinity (AUC [(0-inf])|Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring AUC(0-inf). AUC(0-inf) = AUC0-t + (Clast/kel), where, AUC0-t= area under the plasma concentration versus time curve from time zero to time t; Clast= last observed/measured plasma concentration and kel= elimination rate constant. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (AUC[0-inf]), as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the GMR between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.|0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period|Analysis performed on PKAS1, that included all randomized participants who completed both periods, had no major protocol deviations concerning pharmacokinetics, excluding those with baseline nicotine concentration > 5% of individual Cmax for either period. Here, number analyzed indicates participants with available data for this outcome measure.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2527906|NCT03541044|Primary|Assessment of Bioequivalence of Prototype Mini Lozenges With Nicorette Mini Lozenge by Measuring Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t (AUC [0-t])|Bioequivalence of prototype mini lozenges with nicorette mini lozenge was assessed by measuring AUC(0-t), where t= time of the last measurable plasma concentration. AUC(0-t) was calculated using the linear trapezoidal with linear interpolation method. A linear mixed-effects model was fit to the natural log (ln)-transformed PK variable (AUC0-t), as the dependent variable, and treatment, period, and sequence as fixed effects. Participant nested within sequence was a random effect. The treatment difference and its 90% CI were exponentiated to obtain the geometric mean ratios (GMR) between the test and reference products and its 90% CI. Geometric Coefficient of variation was provided as percentage.|0.75, 0.5, 0.25 hours predose and 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 2, 3, 4, 6, 8 10, 14, 16, 20 and 24 hours postdose in each treatment period|Pharmacokinetic analysis set1 (PKAS1) included all randomized participants who completed both periods, had no major protocol deviations concerning pharmacokinetics, excluding those with baseline nicotine concentration greater than (>) 5 percent (%) of individual highest observed plasma nicotine concentration (Cmax) for either period.|||nanograms*hours per milliliter(ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2527907|NCT03538717|Secondary|Overall Survival (OS) From Subsequent Treatments Post Axitinib Treatment|OS was defined as the time from the date of randomization to treatment up to the date of death due to any cause.|From initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)|FAS population was analyzed. This outcome measure as per protocol was intended to be analyzed only in long responders group. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure.|||months||Standard Error|Median
2527908|NCT03538717|Secondary|Number of Participants With Reasons to Discontinue Subsequent Treatments Post Axitinib Treatment: All Participants|In this outcome measure, participants who stopped subsequent treatments after axitinib discontinuation due to any reasons like PD, toxicity and others are reported.|From initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)|FAS population was analyzed. This outcome measure as per protocol was intended to be analyzed only in long responders group. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2527909|NCT03538717|Secondary|Number of Participants With First Best Response to Subsequent Treatments Post Axitinib Treatment|Best response is CR and PR, SD or PD. As per RECIST1.1 criteria: CR = disappearance of all target lesions; PR = >= 30% decrease in sum of target lesions taking as reference baseline sum diameters; PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions; SD =neither shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameters while on treatment.|From initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)|FAS population was analyzed. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure. As per protocol, no comparison was planned between long responders and refractory participants.|||Participants|||Count of Participants
2527910|NCT03538717|Secondary|Duration of Subsequent Treatments Post Axitinib Treatment: All Participants||Upon initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)|FAS population was analyzed. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure. As per protocol, no comparison was planned between long responders and refractory participants.|||months||Full Range|Median
2527911|NCT03538717|Secondary|Number of Participants as Per Number of Subsequent Lines of Treatment Received Post Axitinib Treatment: All Participants||Upon initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)|FAS population was analyzed. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure. As per protocol, no comparison was planned between long responders and refractory participants.|||Participants|||Count of Participants
2527912|NCT03538717|Secondary|Number of Participants Receiving Subsequent Treatment Post Axitinib Treatment: All Participants||Upon initiation of subsequent treatment (post axitinib treatment) to a maximum subsequent treatment duration of 2.9 years approximately (from data collected and observed retrospectively for 1 year)|FAS population was analyzed. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure. As per protocol, no comparison was planned between long responders and refractory participants.|||Participants|||Count of Participants
2528271|NCT03519919|Secondary|Overall Comfort|Subjective rating of comfort for habitual lens and somofilcon A multifocal lens at 3 weeks (Prefer my own strongly, Prefer my own slightly, No preference, Prefer study lenses slightly, Prefer study lenses strongly)|3 weeks||||percentage of participants|||Number
2527913|NCT03538717|Secondary|Number of Participants With Adverse Events (AE): All Participants|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse events (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. AEs included both SAEs and non-SAEs.|For first line treatment: maximum of 6.6 years approximately; for axitinib treatment: maximum of 5.4 years approximately; for post-axitinib subsequent treatments: maximum of 2.9 years approximately (data collected and observed retrospectively for 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. As per protocol, no comparison was planned between long responders and refractory participants.|||Participants|||Count of Participants
2527914|NCT03538717|Secondary|Percentage of Participants With Reduced Doses of Axitinib of More Than 5 Milligram (mg) Twice Daily: All Participants|Percentage of participants whose axitinib dose was reduced 5 mg dose at least 1 time in 12 hours (twice daily) are reported in this outcome measure.|For maximum axitinib treatment duration of 5.4 years, approximately (data collected and observed retrospectively for 1 year)|FAS population was analyzed. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure. As per protocol, no comparison was planned between long responders and refractory participants.|||Percentage of participants|||Number
2527915|NCT03538717|Secondary|Percentage of Participants With Titrated (Increased) Doses of Axitinib of More Than 5 Milligram (mg) Twice Daily: All Participants|Percentage of participants whose axitinib dose was titrated and increased to more than 5mg dose at least 1 time in 12 hours (twice daily), are reported in this outcome measure.|For maximum axitinib treatment duration of 5.4 years, approximately (from data collected and observed retrospectively for 1 year)|FAS population was analyzed. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure. As per protocol, no comparison was planned between long responders and refractory participants.|||Percentage of participants|||Number
2527916|NCT03538717|Secondary|Duration of Axitinib Treatment: All Participants|Duration of treatment with axitinib was the time from date of start of axitinib treatment to date of end of axitinib treatment or of latest follow-up if not suspended.|Day 1 of axitinib treatment to end of treatment or date of latest follow-up if not suspended for maximum axitinib therapy duration of 5.4 years, approximately (from data collected and observed retrospectively for 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. As per protocol, no comparison was planned between long responders and refractory participants.|||months||Full Range|Median
2527917|NCT03538717|Secondary|Overall Survival (OS) to Axitinib as the Second Line of Treatment and Subsequent Treatment in Group of Long Responders|OS was defined as the time from the date of start of second line of treatment and subsequent treatment till the date of death due to any cause. If there was no death, the case was censored as OS at latest follow-up.|From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment to death due to any cause/date of latest follow-up if censored upto max. of 5.4 yrs., approx. (data collected, observed retrospectively 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. This outcome measure as per protocol was intended to be analyzed only in long responders group.|||months||Standard Error|Median
2527918|NCT03538717|Secondary|Time to Progression (TTP) to Axitinib as the Second Line of Treatment and Subsequent Treatment in Group of Long Responders|TTP was defined as the time from the start of second line of treatment and subsequent treatment to date of disease progression. If there was no progression, the case was censored as TTP at latest follow-up. PD: >=20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions.|From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment to PD/date of latest follow-up if censored up to max. treatment duration of 5.4 yrs., approx. (data collected, observed retrospectively 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. This outcome measure as per protocol was intended to be analyzed only in long responders group.|||months||Standard Error|Median
2527919|NCT03538717|Secondary|Clinical Benefit Rate (CBR) to Axitinib as the Second Line of Treatment and Subsequent Treatment in Group of Long Responders|CBR was defined as the frequency of participants with CR, PR or SD. As per RECIST1.1 criteria: CR = disappearance of all target lesions; PR = >= 30% decrease in sum of target lesions taking as reference baseline sum diameters; PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions; SD =neither shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameters while on treatment.|From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment up to a maximum axitinib therapy duration of 5.4 years approximately (data collected and observed retrospectively for 1 year)|FAS population was analyzed. This outcome measure as per protocol was intended to be analyzed only in long responders group.|||Participants|||Count of Participants
2527920|NCT03538717|Secondary|Objective Response Rate (ORR) to Axitinib as Second Line of Treatment and Subsequent Treatment in Group of Long Responders|ORR was defined as the number of participants with CR or PR. As per RECIST1.1 criteria: CR = disappearance of all target lesions; PR = >= 30% decrease in sum of target lesions taking as reference baseline sum diameters.|From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment up to a maximum axitinib therapy duration of 5.4 years approximately (data collected and observed retrospectively for 1 year)|FAS population was analyzed. This outcome measure as per protocol was intended to be analyzed only in long responders group.|||Participants|||Count of Participants
2528724|NCT03491553|Secondary|Change From Baseline in Serum qHBsAg at Week 4||Baseline, Week 4|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2527921|NCT03538717|Secondary|Progression-free Survival (PFS) to Axitinib as Second Line of Treatment and Subsequent Treatment in Group of Long Responders|PFS was defined as the time from the start of axitinib as second line of treatment and subsequent treatment to disease progression or death by any cause. If there was no progression or death, the case was censored as PFS at date of latest follow-up. As per RECIST 1.1, PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions.|From first dose of axitinib as second line and from first dose of axitinib as subsequent lines to PD/death by any cause/date of latest follow-up if censored up to a max. axitinib therapy of 5.4 yrs. approx. (data collected, observed retrospectively 1 yr.)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. This outcome measure as per protocol was intended to be analyzed only in long responders group.|||months||Standard Error|Median
2527922|NCT03538717|Secondary|Number of Participants With Best Response to Axitinib as Second Line of Treatment and Subsequent Treatment in Group of Long Responders|In this outcome measure, data for number of participants with best response to axitinib as second line of treatment and subsequent treatment was collected. Best response is CR and PR, SD or PD. As per RECIST1.1 criteria: CR = disappearance of all target lesions; PR = >= 30% decrease in sum of target lesions taking as reference baseline sum diameters; PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions; SD =neither shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameters while on treatment. Subsequent treatment referred to further treatment after second line of treatment.|From first dose of axitinib as second line of treatment and from first dose of axitinib as subsequent treatment up to a maximum axitinib therapy duration of 5.4 years approximately (data collected and observed retrospectively for 1 year)|FAS population was analyzed. This outcome measure as per protocol was intended to be analyzed only in long responders group.|||Participants|||Count of Participants
2527923|NCT03538717|Secondary|Overall Survival (OS) From Axitinib Treatment in Group of Long Responders|OS was defined as the time from the date of start of axitinib treatment to the date of death due to any cause. If there was no death, the case was censored as OS at latest follow-up.|Day 1 of axitinib dose to death due to any cause or date of latest follow-up in case of censored up to a maximum axitinib therapy of 5.4 years, approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. This outcome measure as per protocol was intended to be analyzed only in long responders group.|||months||Standard Error|Median
2527924|NCT03538717|Secondary|Time to Progression (TTP) to Axitinib Treatment in Group of Long Responders|TTP was defined as the time from the start of axitinib treatment to date of disease progression. If there was no progression, the case was censored as TTP at latest follow-up. As per RECIST 1.1, PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions.|Day 1 of axitinib dose to disease progression or date of latest follow-up in case of censored up to a maximum (max.)axitinib therapy duration of 5.4 years(yrs.)approximately(approx.)(from the data collected, observed retrospectively during 1 year [yr.])|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. This outcome measure as per protocol was intended to be analyzed only in long responders group.|||months||Standard Error|Median
2527925|NCT03538717|Secondary|Progression-free Survival (PFS) to Axitinib Treatment in Group of Long Responders|PFS was defined as the time from the start of axitinib treatment to disease progression or death by any cause. If there was no progression or death, the case was censored as PFS at date of latest follow-up. PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of >=1 new lesions.|Day 1 of axitinib dose to disease progression or death due to any cause or date of latest follow-up in case of censored up to a maximum axitinib therapy of 5.4 years, approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. This outcome measure as per protocol was intended to be analyzed only in long responders group.|||months||Standard Error|Median
2527926|NCT03538717|Primary|Number of Participants With Smoking Habits at Initiation of First Line Treatment: Long Responders Versus Refractory Participants|In this outcome measure, data for smoking habit of participants was compared between long responders and refractory participants.|At initiation of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2527927|NCT03538717|Primary|Number of Participants With Laboratory Parameters at Initiation of First Line Treatment: Long Responders Versus Refractory Participants|In this outcome measure, data for different laboratory parameters at initiation of first line treatment: LDH level >1.5*ULN, haemoglobin (Hgb) levels <=LLN, corrected Ca levels >10 mg/dL, neutrophil levels >ULN, platelet levels >ULN and neutrophil-to-lymphocyte ratio of <=3 was compared between long responders and refractory participants.|At initiation of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study.|||Participants|||Count of Participants
2528001|NCT03535571|Secondary|Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-10 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).|Measured by the Multi-Analyte ELISArray|Baseline (Day 0) to end-of-study (Day 128)|Intent to treat population|||pg/mL||Standard Deviation|Mean
2527928|NCT03538717|Primary|Number of Participants With Different Metastatic Sites Locations at Diagnosis of Advance or Metastatic Renal Cell Carcinoma Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants|In this outcome measure, data for participants with different metastatic sites as lymph nodes, central nervous system (CNS), hepatic, pulmonary, bone and another site of metastasis at diagnosis of advance or mRCC before axitinib treatment initiation, was compared between long responders and refractory participants.|At diagnosis of advance or mRCC prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study.|||Participants|||Count of Participants
2527929|NCT03538717|Primary|Number of Participants With 1 or More Metastatic Locations at Diagnosis of Advance or Metastatic Renal Cell Carcinoma Before First Line Treatment Initiation: Long Responders Versus Refractory Participants||At diagnosis of advance or mRCC prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study.|||Participants|||Count of Participants
2527930|NCT03538717|Primary|Number of Participants With Best Response to First Line Treatment With Tyrosine Kinase Inhibitor (TKI) Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants|In this outcome measure, data for participants with their best response as complete response (CR) and partial response (PR), stable disease (SD) or progressive-disease (PD) to the first line treatment with TKI, was compared between long responders and refractory participants. As per response evaluation criteria in solid tumors (RECIST) 1.1 criteria: CR = disappearance of all target lesions. PR = greater than equal to (>=) 30% decrease in sum of target lesions taking as reference baseline sum diameters. PD: >= 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm), or the appearance of >=1 new lesions. SD =neither shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters during treatment.|First dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2527931|NCT03538717|Primary|Number of Participants With Duration of First Line Treatment With Tyrosine Kinase Inhibitor (TKI) Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants|Duration of first line treatment with TKI was stratified into 0-3 months, 3-6 months, 6-9 months, 9-12 months and >12 months and compared between long responders and refractory participants.|First dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2527932|NCT03538717|Primary|Number of Participants With Different Type of Renal Cells Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants|In this outcome measure, data for participants who had renal cells with different type of histology as 100% clear cells, 100% non-clear cells, majority component of clear cells and majority component of non-clear cells was compared between long responders and refractory participants.|Prior to first dose of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2527933|NCT03538717|Primary|Number of Participants With International Metastatic Database Consortium (IMDC) Risk Group on Discontinuation of Axitinib Treatment: Long Responders Versus Refractory Participants|IMDC risk group stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 poor prognostic factors. Poor-risk group: participants had 3 to 6 poor prognostic factors. Poor prognostic factors included KPS score of <80 at the initiation of treatment, time from diagnosis to metastasis treatment of <12 months, anemia, hypercalcemia (corrected calcium >10 mg/dL), neutrophilia and thrombocythemia. In this outcome measure, IMDC risk group (favorable, intermediate, poor: on discontinuation of axitinib) was compared between long responders and refractory participants.|On discontinuation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2527951|NCT03537404|Primary|Cmax of Tenofovir|Maximum observed Concentration of Tenofovir at Day 5 of treatment B and C of Part 1 of the study|Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 18 and 24 hrs post-dose on Day 5 of treatment B and C (Part 1)|All subjects randomized to study treatment and received at least one dose of study drug.|||ng/ml||90% Confidence Interval|Geometric Mean
2527952|NCT03537404|Primary|AUCtau of Narlaprevir|Area Under the Concentration-time curve during a dosing interval τ at steady state of Narlaprevir at Day 5 of treatment A and C of Part 1/ Part 2 of the study|Day 5 Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 5 of treatment A and C (Part 1/ Part 2)|All subjects randomized to study treatment and received at least one dose of study drug.|||ng*h/ml||90% Confidence Interval|Geometric Mean
2527934|NCT03538717|Primary|Number of Participants With International Metastatic Database Consortium (IMDC) Risk Group at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants|IMDC risk group stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 poor prognostic factors. Poor-risk group: participants had 3 to 6 poor prognostic factors. Poor prognostic factors included KPS score of <80 at the initiation of treatment, time from diagnosis to metastasis treatment of <12 months, anemia, hypercalcemia (corrected calcium >10 mg/dL), neutrophilia and thrombocythemia. In this outcome measure, IMDC risk group (favorable, intermediate, poor: at initiation of axitinib) was compared between long responders and refractory participants.|At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2527935|NCT03538717|Primary|Number of Participants With Memorial Sloan Kettering Cancer Center (MSKCC) Risk Group on Discontinuation of Axitinib Treatment: Long Responders Versus Refractory Participants|MSKCC risk system stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 adverse prognostic factors. Poor-risk group: participants had more than 2 poor prognostic factors. Poor prognostic factors included a KPS of <80 (KPS score quantify participant's general well-being and activities of daily life, based on their functional impairment. KPS score ranges between 0= death to 100= no evidence of disease; higher score means higher ability to perform daily tasks), time from diagnosis to treatment for more than 12 months, serum LDH >1.5*ULN, corrected serum calcium level >10.0 mg/dL and hemoglobin < LLN.|On discontinuation of axitinib treatment, within axitinib therapy during treatment of maximum 5.4 years, approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2527936|NCT03538717|Primary|Number of Participants With Memorial Sloan Kettering Cancer Center (MSKCC) Risk Group at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants|MSKCC risk system stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 adverse prognostic factors. Poor-risk group: participants had more than 2 poor prognostic factors. Poor prognostic factors included a KPS of <80 (KPS score quantify participant's general well-being and activities of daily life, based on their functional impairment. KPS score ranges between 0= death to 100= no evidence of disease; higher score means higher ability to perform daily tasks), time from diagnosis to treatment for more than 12 months, serum LDH >1.5*ULN, corrected serum calcium level >10.0 mg/dL and hemoglobin < LLN.|At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2527937|NCT03538717|Primary|Number of Participants With Memorial Sloan Kettering Cancer Center (MSKCC) Risk Group Before First Line Treatment Initiation: Long Responders Versus Refractory Participants|MSKCC risk system stratifies participants with mRCC into poor, intermediate and favorable risk groups based on number of adverse clinical and laboratory parameters present. Favorable-risk group: participants had no poor prognostic factors. Intermediate-risk group: participants had 1 or 2 adverse prognostic factors. Poor-risk group: participants had more than 2 poor prognostic factors. Poor prognostic factors included a Karnofsky performance status (KPS) of less than (<) 80 (KPS score quantify participant's general well-being and activities of daily life, based on their functional impairment. KPS score ranges between 0= death to 100= no evidence of disease; higher score means higher ability to perform daily tasks), time from diagnosis to treatment for more than 12 months, serum lactate dehydrogenase (LDH) >1.5*upper limit of normal (ULN), corrected serum calcium level >10.0 milligram per deciliter (mg/dL) and hemoglobin < lower limit of normal (LLN).|Prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2527938|NCT03538717|Primary|Number of Participants With Nephrectomy Procedure Status Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants|Nephrectomy is a surgical removal of kidney. Data for participants was categorized as yes and no to depict their nephrectomy status before axitinib treatment initiation and comparison was done between long responders and refractory participants.|Prior to first dose of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study.|||Participants|||Count of Participants
2527939|NCT03538717|Primary|Number of Participants With 1 or More Different Treatment Lines Before Axitinib Treatment Initiation: Long Responders Versus Refractory Participants||Prior to first dose of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study.|||Participants|||Count of Participants
2527940|NCT03538717|Primary|Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status on Axitinib Discontinuation: Long Responders Versus Refractory Participants|ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, >=2: on axitinib discontinuation), was compared between long responders and refractory participants.|On discontinuation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2527941|NCT03538717|Primary|Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants|ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, >=2: at initiation of axitinib), was compared between long responders and refractory participants.|At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2527942|NCT03538717|Primary|Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Before First Line Treatment Initiation: Long Responders Versus Refractory Participants|ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. In this outcome measure, data for ECOG status (0, 1, >=2: before first line treatment initiation), was compared between long responders and refractory participants.|Prior to first dose of first line treatment, within first line therapy of maximum 6.6 years approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2527943|NCT03538717|Primary|Number of Participants With Age Less Than or Equal to (<=) 65 Years and Greater Than (>) 65 Years at Initiation of Axitinib Treatment: Long Responders Versus Refractory Participants||At initiation of axitinib treatment, within axitinib therapy of maximum 5.4 years approximately (from the data collected and observed retrospectively during 1 year)|FAS included all evaluable participants, i.e. all participants who met all the inclusion criteria and none of the exclusion criteria and have received at least 1 dose of axitinib prior to inclusion in the study. Here, “Overall Number of Participants” signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2527944|NCT03537404|Secondary|Number of Patients With Abnormal ECG Changes|There were no subjects with abnormal ECG changes during the study|Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study|All subjects randomized to study treatment and received at least one dose of study drug|||Participants|||Count of Participants
2527945|NCT03537404|Secondary|Number of Patients With Abnormal Laboratory Values||Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study|All subjects randomized to study treatment and received at least one dose of study drug separately for each Patr of the study|||Participants|||Count of Participants
2527946|NCT03537404|Secondary|Number of Patients With Changes in Vital Signs|There were no subjects with abnormal changes in vital signs|Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study|All subjects randomized to study treatment and received at least one dose of study drug|||Participants|||Count of Participants
2527947|NCT03537404|Secondary|Number of Patients With Adverse Events||Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study|All subjects randomized to study treatment and received at least one dose of study drug|||Participants|||Count of Participants
2527948|NCT03537404|Primary|AUCtau of Raltegravir|Area Under the Concentration-time curve during a dosing interval τ at steady state of Tenofovir at Day 5 of treatment B and C of Part 2 of the study|Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose of Day 5 of treatment B and C (Part 2)|All subjects randomized to study treatment and received at least one dose of study drug.|||ng*h/ml||90% Confidence Interval|Geometric Mean
2527949|NCT03537404|Primary|Cmax of Raltegravir|Maximum observed Concentration of Raltegravir at Day 5 of treatment B and C of Part 2 of the study|Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose of Day 5 of treatment B and C (Part 2)|All subjects randomized to study treatment and received at least one dose of study drug.|||ng/ml||90% Confidence Interval|Geometric Mean
2527973|NCT03535844|Secondary|Change in Body Composition|Dual-energy X-ray absorptiometry|Pre- and post-intervention (Week 16)||||% Body Fat||Standard Deviation|Mean
2527974|NCT03535844|Secondary|Change in Oxidative Stress-related Biomarkers|Concentrations of plasma biomarkers of oxidative stress.|Pre- and post-intervention (Week 16)||||uM||Standard Deviation|Mean
2527953|NCT03537404|Primary|Cmax of Narlaprevir|Maximum observed Concentration of Narlaprevir at Day 5 of treatment A and C of Part 1 or 2 of the study|Day 5 Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 5 of treatment A and C (Part 1/ Part 2)|All subjects randomized to study treatment and received at least one dose of study drug.|||ng/ml||90% Confidence Interval|Geometric Mean
2527954|NCT03537274|Primary|Number of Participants Achieving Sustained Responder Status at 24 Weeks of Follow-up|The number of participants achieving sustained responder status at 24 weeks of follow-up was assessed. A participant was classified as a sustained responder if, at 24 weeks of follow-up, they met both of the following criteria: 1) HCV-RNA negative (defined as <100 copies/mL serum by qPCR assay); and 2) ALT level normal.|Up to 72 weeks (up to 48 weeks treatment and 24 weeks follow-up)|Includes all randomized participants receiving ≥1 dose of study treatment.|||Participants|||Count of Participants
2527955|NCT03537274|Primary|Number of Participants Achieving Responder Status at 24 Weeks of Treatment|The number of participants achieving responder status at 24 weeks of treatment was assessed. A participant was classified as a responder if, at 24 weeks of treatment, they met both of the following criteria: 1) HCV-Ribonucleic Acid (RNA) negative (defined as <100 copies/mL serum by quantitative polymerase chain reaction [qPCR] assay); and 2) alanine transaminase (ALT) level normal.|Up to 24 weeks|Includes all randomized participants receiving ≥1 dose of study treatment.|||Participants|||Count of Participants
2527956|NCT03537092|Secondary|Acceptability of Vaginal Film Use|The acceptability of vaginal film use by the participant will be assessed on a 5 point Likert scale|30 days|Participants who responded to the question 'Overall I was satisfied with my experience with this film, once it was inserted' at Visit 4.|||Participants|||Count of Participants
2527957|NCT03537092|Secondary|Difficulty of Vaginal Film Insertion|The perceived difficulty of vaginal film insertion by the participant will be assessed on a 4 point Likert scale|30 days|The number of participants who responded to this survey question after product insertion.|||Participants|||Count of Participants
2527958|NCT03537092|Secondary|Correct Insertion of Vaginal Film|Vaginal film was correctly inserted by the participant as assessed by clinical investigator|30 days||||Participants|||Count of Participants
2527959|NCT03537092|Primary|Grade 2 or Higher Urogenital System Adverse Event Related to Film Use|Any urogenital adverse event that occurs with a severity of Grade 2 (moderate) or higher that is deemed to be related to product use by the clinical primary investigator|30 days||||Participants|||Count of Participants
2527960|NCT03536923|Secondary|Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction)|"Change in pelvic floor muscle performance will be evaluated using muscle performance testing performed using the leva device. Subjects were asked to lift and squeeze pelvic floor muscles for as long as possible. The length of time a subject can hold the lift was recorded"|6 weeks||||seconds||Standard Deviation|Mean
2527961|NCT03536923|Secondary|Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I)|Subject perception of improvement will be evaluated using the standardized survey Patient Global Impression of Improvement (PGI-I). Categories of improvement include: Very Much Better, Much Better, A Little Better, No Change, Worse(any degree).|At 6 weeks||||Participants|||Count of Participants
2527962|NCT03536923|Secondary|Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks.|Condition specific quality of life as it is affected by urinary incontinence will be assessed using the Incontinence Impact Questionnaire (IIQ-7). Minimum value 0, Maximum value 100, lower scores indicate improvement.|6 weeks||||score on a scale||Standard Deviation|Mean
2527963|NCT03536923|Primary|Symptoms of Urinary Incontinence at Baseline and at 6 Weeks|A validated, standardized questionnaire (the short form of the urogenital distress inventory, UDI-6) will be used to evaluate change in symptoms of urinary incontinence. Minimum score = 0, Maximum score = 100, lower scores indicate fewer symptoms.|6 weeks||||score on a scale||Standard Deviation|Mean
2527964|NCT03535844|Primary|Change in Plasma ICAM-1|Concentrations of plasma intercellular adhesion molecule-1 using commercially available ELISA assay kits.|Pre- and post-intervention (Week 16)||||ng/mL||Standard Deviation|Mean
2527965|NCT03535844|Primary|Change in Plasma Endothelin-1|Concentrations of plasma endothelin-1 using commercially available ELISA assay kits.|Pre- and post-intervention (Week 16)||||pg/mL||Standard Deviation|Mean
2527966|NCT03535844|Secondary|Change in Cognitive Function|Measured using Montreal cognitive assessment (MOCA)|Pre- and post-intervention (Week 16)||2020-09-30|09/2020||||
2527967|NCT03535844|Secondary|Change in Sleep Quality|Measured using The Pittsburgh Sleep Quality Index (PSQI) and sleep evaluation questionnaire|Pre- and post-intervention (Week 16)||2020-09-30|09/2020||||
2527968|NCT03535844|Secondary|Dietary Carotenoids|Analysis of dietary carotenoids using 3-day food records|Pre- and post-intervention (Week 16)||||ug||Standard Deviation|Mean
2527969|NCT03535844|Secondary|Change in Appetite|"A subjective visual analogue scale consisting of a 100 mm line for each term (1) hunger; (2) fullness; (3) desire to eat; (4) prospective food consumption. Subjects respond by placing a mark on the line that is anchored with an extreme answer at either end (e.g. not felt at all and felt the greatest)~A composite appetite score is computed by: (hunger + desire to eat + (100 - fullness) + prospective food consumption) divided by 4. With a maximum score of 400 for the greatest possible appetite (represented by hunger = 100; desire to eat = 100; fullness = 0 and prospective food consumption = 100) and a minimum score of 0 (represented by hunger = 0; desire to eat = 0; fullness = 100 and prospective food consumption = 0)"|Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported||||score on a scale||Standard Deviation|Mean
2527970|NCT03535844|Secondary|Change in Waist Circumference|Measurement of waist circumference using World Health Organization guidelines|Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported||||cm||Standard Deviation|Mean
2527971|NCT03535844|Secondary|Body Mass Index|(body mass) divided by (height x height)|Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported||||kg/m^2||Standard Deviation|Mean
2527972|NCT03535844|Secondary|Change in Skin Carotenoid Status|Measured using resonance Raman spectroscopy to obtain a skin carotenoid status, a score which ranges from 10000 to 89000. Higher score represents higher concentration of carotenoids in skin, hence, an improved outcome|Assessed at week 0, week 4, week 8, week 12 and week 16, week 0 and 16 reported||||score on a scale||Standard Deviation|Mean
2536685|NCT03159299|Secondary|Change in Dietary Intake From Baseline|Dietary intake will be evaluated by a two-day diet history|6 months|||||||
2527983|NCT03535649|Secondary|Percentage of Participants With Mucosal Healing at Weeks 6 and 14|Mucosal healing was defined as Mayo endoscopic sub-score of 0 or 1 compared to baseline. Mayo score was an instrument designed to measure disease activity of UC. Endoscopic findings was a sub-score of complete Mayo score, which ranges from 0 to 3 (0= Normal or inactive disease; 1= Mild disease; 2= Moderate disease; 3= Severe disease), with higher scores indicating more severe disease.|Weeks 6 and 14|The FAS consisted all enrolled participants who received at least one dose of study medication and had active disease at baseline. Here, n (number analyzed) signifies number of participants who were analyzed at specified time point.|||percentage of participants|||Number
2527984|NCT03535649|Secondary|Percentage of Participants With Clinical Remission at Week 6 and Week 14 Based on Partial Mayo Score|Clinical remission was defined as a total mayo score of less than or equal to (<=) 2 with no sub-score greater than (>) 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9; where higher score indicated more severe disease.|Weeks 6 and 14|The FAS consisted all enrolled participants who received at least one dose of study medication and had active disease at baseline. Here, n (number analyzed) signifies number of participants who were analyzed at specified time point.|||percentage of participants|||Number
2527985|NCT03535649|Secondary|Percentage of Participants With Clinical Response at Week 14 Based on Partial Mayo Score|Clinical response was defined as a reduction of at least 3 points and a decrease of at least 30% from the baseline mayo score, with a decrease of at least 1 point on the rectal bleeding subscale, or an absolute rectal bleeding score of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, endoscopic findings and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher scores indicated more severe disease.|Week 14|The FAS consisted all enrolled participants who received at least one dose of study medication and had active disease at baseline. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2527986|NCT03535649|Primary|Percentage of Participants With Pregnancy During the Study||From the index date (date when vedolizumab treatment was initiated) until the end of treatment, lost to follow-up or death (up to 15 months)|The SAS consisted all enrolled participants who received at least one documented dose of study medication.|||percentage of participants|||Number
2527987|NCT03535649|Primary|Percentage of Participants With Adverse Events of Special Interests (AESIs) and Serious Adverse Events (SAEs)||From the index date (date when vedolizumab treatment was initiated) until the end of treatment, lost to follow-up or death (up to 15 months)|The SAS consisted all enrolled participants who received at least one documented dose of study medication.|||percentage of participants|||Number
2527988|NCT03535649|Primary|Percentage of Participants With Clinical Response at Week 6 Based on Partial Mayo Score|Clinical response based on partial Mayo score was defined as a reduction of at least 3 points and a decrease of at least 30 percent (%) from the baseline Mayo score, with a decrease of at least 1 point on the rectal bleeding subscale, or an absolute rectal bleeding score of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. Partial Mayo score consisted of 3 sub-scores: stool frequency, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed to give a total score range of 0 to 9; where higher score indicated more severe disease.|Week 6|The full analysis set (FAS) consisted all enrolled participants who received at least one dose of study medication and had active disease at baseline. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2527989|NCT03535571|Other Pre-specified|The Effect of a 128-day Supplementation on Hip Circumference||Baseline (Day 0) to end-of-study (Day 128)||||cm||Standard Deviation|Mean
2527990|NCT03535571|Other Pre-specified|The Effect of a 128-day Supplementation on Waist Circumference||Baseline (Day 0) to end-of-study (Day 128)||||cm||Standard Deviation|Mean
2527991|NCT03535571|Other Pre-specified|The Effect of a 128-day Supplementation on Heart Rate||Baseline (Day 0) to end-of-study (Day 128)||||beats per minute||Standard Deviation|Mean
2527992|NCT03535571|Other Pre-specified|The Effect of a 128-day Supplementation on Blood Pressure||Baseline (Day 0) to end-of-study (Day 128)||||mmHg||Standard Deviation|Mean
2527993|NCT03535571|Other Pre-specified|The Effect of a 128-day Supplementation on Weight||Baseline (Day 0) to end-of-study (Day 128)|Intent to treat population|||kg||Standard Deviation|Mean
2527994|NCT03535571|Other Pre-specified|The Incidence of Adverse Events Following a 128-day Supplementation||Baseline (Day 0) to end-of-study (Day 128)|Frequency Threshold for Reporting Other Adverse Events: 5%. Full information can be found in the adverse events section. Summary can be found below.|||Participants|||Count of Participants
2527995|NCT03535571|Secondary|Change in Score of the Hair, Nails, and Skin Self-Assessment Questionnaire After 128-day Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)|"This questionnaire consists of a total of 7 questions that assess the participant`s perception on hair (4 questions), nail (1 question) and skin health (2 question). The response to each question can range from 1 to 6 where 1 indicates greatly satisfied and 6 indicates greatly dissatisfied.~The range for the total score on this questionnaire is 7-42. Lower total score indicates a better outcome, and higher total score indicates a worse outcome."|Baseline (Day 0) to end-of-study (Day 128)|Intent to treat population|||score on a scale||Standard Deviation|Mean
2527996|NCT03535571|Secondary|Change From Baseline to Day 128 in Fasting Glucose After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)||Baseline (Day 0) to end-of-study (Day 128)|Intent to treat population|||mmol/L||Standard Deviation|Mean
2527997|NCT03535571|Secondary|Change From Baseline to Day 128 in Glycated Hemoglobin (HbA1c) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)||Baseline (Day 0) to end-of-study (Day 128)|Intent to treat population|||percentage of glucose bound to RBCs||Standard Deviation|Mean
2528580|NCT03500159|Secondary|Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-C|AQX-1125 200 mg compared to placebo as measured by the Patient's Global Impression of Change Scale (PGI-C) at Week 12|12 Weeks|||||||
2528005|NCT03535571|Secondary|Change From Baseline to Day 128 in Total Reactive Oxygen Species/Reactive Nitrogen Species Free Radical Activity After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)|Assessed by ROS/RNS assay|Baseline (Day 0) to end-of-study (Day 128)|Intent to treat population|||mmol/L||Standard Deviation|Mean
2528006|NCT03535571|Secondary|Change From Baseline to Day 128 in Relative Expression of 84 Stress Genes After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)|Evaluated by oxidative stress-related gene RT Profiler PCR array. Seven of the 84 genes were upregulated, which are highlighted in the results.|Baseline (Day 0) to end-of-study (Day 128)|Intent to treat population|||Fold change||Standard Deviation|Mean
2528007|NCT03535571|Secondary|Change From Baseline to Day 128 in Hemoglobin (Hb) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)||Baseline (Day 0) to end-of-study (Day 128)|Intent to treat population|||g/L||Standard Deviation|Mean
2528008|NCT03535571|Secondary|Change From Baseline to Day 128 in Red Cell Distribution Width (RDW) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)||Baseline (Day 0) to end-of-study (Day 128)|Intent to treat population|||percent change in size||Standard Deviation|Mean
2528009|NCT03535571|Secondary|Change From Baseline to Day 128 in Hematocrit After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)||Baseline (Day 0) to end-of-study (Day 128)|Intent to treat population|||L/L||Standard Deviation|Mean
2528010|NCT03535571|Secondary|Change From Baseline to Day 128 in Mean Corpuscular Hemoglobin Concentration (MCHC) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)||Baseline (Day 0) to end-of-study (Day 128)|Intent to treat population|||g/L||Standard Deviation|Mean
2528011|NCT03535571|Secondary|Change From Baseline to Day 128 in Mean Corpuscular Hemoglobin (MCH) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)||Baseline (Day 0) to end-of-study (Day 128)|Intent to treat population|||pg||Standard Deviation|Mean
2528012|NCT03535571|Secondary|Change From Baseline to Day 128 in Mean Corpuscular Volume (MCV) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)||Baseline (Day 0) to end-of-study (Day 128)|Intent to treat population|||fL||Standard Deviation|Mean
2528013|NCT03535571|Secondary|Change From Baseline to Day 128 in Red Blood Cell (RBC) Count After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)||Baseline (Day 0) to end-of-study (Day 128)|Intent to treat population|||cells x10^12/L||Standard Deviation|Mean
2528014|NCT03535571|Primary|The Change From Baseline (Day 0) to End-of-study (Day 128) in Energy Level After a 128-day Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)|"This questionnaire consists of a total of 30 questions that assess vitality and quality of life. The responses for these questions range from 1 to 7, where 1 indicates never or not at all true 4 indicates sometimes or somewhat true and 7 indicates always or very true depending on the item that is assessed by the question.~15 of the 30 questions are positively keyed in which a higher score indicates a better outcome and remaining 15 questions are negatively keyed where a lower score indicates a better outcome. The responses on the negatively keyed questions will be reversed prior to calculating the total score (i.e. a response of 1 will be considered as 7, 2 will be considered as 6, etc.). Total range will be 30-210, where a higher total score indicates a better outcome and a lower total score indicates a worse outcome."|Baseline (Day 0) to end-of-study (Day 128)|Intent to treat population|||score on a scale||Standard Deviation|Mean
2528015|NCT03534986|Primary|FEF25-75%|Forced Expiratory Flow (25-75%), the peak expiratory flow at 25 - 75% FVC|30 minutes||||L/s||Full Range|Mean
2528016|NCT03534986|Primary|FEV1|Forced Expiratory Volume, the volume of air that can be forced out in one second after taking a deep breath|30 minutes||||L||Full Range|Mean
2528017|NCT03534986|Primary|FVC|Forced Vital Capacity, the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible|30 minutes||||L||Full Range|Mean
2528018|NCT03534986|Primary|PEF|Peak Expiratory Flow, a person's maximum speed of expiration|30 minutes||||L/s||Full Range|Mean
2528019|NCT03534986|Primary|TV|Tidal Volume, the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied|30 minutes||||L||Full Range|Mean
2528020|NCT03534427|Primary|Diastolic Blood Pressure||12 weeks||||mmHg||Standard Deviation|Mean
2528021|NCT03534427|Primary|Systolic Blood Pressure|Blood pressure was measured in duplicate using an automated sphygmomanometer. The average of the two was recorded as the resting blood pressure.|12 weeks||||mmHg||Standard Deviation|Mean
2528022|NCT03534427|Primary|C-reactive Protein|C-reactive protein was assessed using an enzyme immunoassay assay kit|12 weeks||||mg/L||Standard Deviation|Mean
2528023|NCT03534427|Primary|Nitrate/Nitrite Levels|Nitrate and nitrite levels were assayed using a Griess assay kit.|12 weeks||||umol||Standard Deviation|Mean
2528024|NCT03534427|Primary|Lean Body Mass|Lean body mass (kg) was determined using a bioelectrical impedance-meter.|12 weeks||||kilograms (kg)||Standard Deviation|Mean
2528025|NCT03534427|Primary|Body Fat|Percent body fat (%) was determined using a bioelectrical impedance-meter.|12 weeks||||percent||Standard Deviation|Mean
2528026|NCT03534427|Primary|Waist Circumference|Waist circumference was measured at midpoint between the lower rib and the iliac crest at the end of a normal expiration using a tape measure.|12 weeks||||cm||Standard Deviation|Mean
2528027|NCT03534427|Primary|Height|Height was measured to nearest 1 cm.|12 weeks||||cm||Standard Deviation|Mean
2528028|NCT03534427|Primary|Body Mass|Body mass was measured to nearest 0.1 kg.|12 weeks||||kilograms (kg)||Standard Deviation|Mean
2528029|NCT03534427|Primary|Endothelin-1|Levels of Endothelin-1 in blood were measured by Endothelin-1 enzyme immunoassay kit.|12 weeks||||umol/mL||Standard Deviation|Mean
2528030|NCT03534427|Primary|Arterial Stiffness|Arterial stiffness was measured as measurement of brachial to ankle pulse-wave velocity. This indicates peripheral arterial stiffness, as it measures how quickly a pulse wave propagates from one point to another.|12 weeks||||m/s||Standard Deviation|Mean
2528050|NCT03533829|Primary|Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive|Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject|Day1|Participant randomized to intervention and vaccinated|||Participants|||Count of Participants
2528031|NCT03534362|Secondary|Surgical Postoperative Complications, Frontal Sinus Pathology|To ascertain the incidence of surgical complications based on the specific frontal sinus pathology.|After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24.|Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.||||||
2528032|NCT03534362|Secondary|Surgical Postoperative Complications, Devices|To compare the incidence of other surgical postoperative complications (diagnosed post-operative cerebrospinal fluid (CSF) leak, epistaxis requiring treatment, adhesions) between Propel stent and Nasopore.|After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24.|Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.||||||
2528033|NCT03534362|Primary|Change From Baseline of Sino-Nasla Outcome Test (SNOT-22) Scores|To compare the difference in mean post-operative SNOT-22 scores between the Propel stent and Nasopore groups.|After the surgery, we will ask patients to follow up 5 times: post-operatively once between week 1-2, once between week 6-8, month 6, month 12, and month 24.|Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.||||||
2528034|NCT03533829|Primary|Number of Subjects Who Would Choose to Have Buzzy® on Their Arm/s During Shot/s Again|Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations|Day1|Participants randomized to intervention and vaccinated|||Participants|||Count of Participants
2528035|NCT03533829|Primary|Number of Subjects Who Were Not Bothered by the Vibration of Buzzy® on Their Arm/s During Shot/s|Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations|Day1|Participants randomized to intervention and vaccinated|||Participants|||Count of Participants
2528036|NCT03533829|Primary|Number of Subjects Who Were Not Bothered by the Cold Temperature of Buzzy® on Their Arm/s During Shot/s|Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations|Day1|Participants randomized to intervention and vaccinated|||Participants|||Count of Participants
2528037|NCT03533829|Primary|Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Comfortable or Very Comfortable|Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations|Day1|Participants randomized to intervention and vaccinated|||Participants|||Count of Participants
2528038|NCT03533829|Primary|Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Easy or Very Easy|Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations|Day1|Participant randomized to intervention and vaccinated|||Participants|||Count of Participants
2528039|NCT03533829|Primary|Number of Subjects Who Either Like a Little or Very Much Liked Having Buzzy® on Their Arm/s During Shot/s|Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations|Day1|Participants randomized to intervention and vaccinated|||Participants|||Count of Participants
2528040|NCT03533829|Primary|Number of Subjects Who Found the Music App Sufficient or Somewhat Sufficient to Selecting the Music They Like|Subjects will complete a survey about the acceptability of the music intervention during their vaccinations|Day1|Participant randomized to intervention and vaccinated|||Participants|||Count of Participants
2528041|NCT03533829|Primary|Number of Subjects Who Would be Somewhat Likely or Very Likely to Want to Listen to Music Again While Receiving Shot/s|Subjects will complete a survey about the acceptability of the music intervention during their vaccinations|Day1|Participants randomized to intervention and vaccinated|||Participants|||Count of Participants
2528042|NCT03533829|Primary|Number of Subjects Who Found the Music Playing While They Got Their Shot/s to be Just Right|Subjects will complete a survey about the acceptability of the music intervention during their vaccinations|Day1|Participants randomized to intervention and vaccinated|||Participants|||Count of Participants
2528043|NCT03533829|Primary|Number of Subjects Who Found Music Playing While Receiving Their Shots to be Somewhat Comfortable or Very Comfortable|Subjects will complete a survey about the acceptability of the music intervention during their vaccinations|Day1|Participants randomized to intervention and vaccinated. One participant did not complete the assessment.|||Participants|||Count of Participants
2528044|NCT03533829|Primary|Number of Subjects Who Felt Having Music Play During Their Shot/s Was Somewhat Easy or Easy|Subjects will complete a survey about the acceptability of the music intervention during their vaccinations|Day1|Participant randomized to intervention and vaccinated|||Participants|||Count of Participants
2528045|NCT03533829|Primary|Number of Subjects Who Like Having Music Play During Their Shot/s a Little or Very Much|Subjects will complete a survey about the acceptability of the music intervention during their vaccinations|Day1|Participant randomized to intervention and vaccinated|||Participants|||Count of Participants
2528046|NCT03533829|Primary|Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive|Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject|Day1|Participant randomized to intervention and vaccinated|||Participants|||Count of Participants
2528047|NCT03533829|Primary|Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy|Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject|Day1|Participant randomized to intervention and vaccinated. One participant did not complete the assessment.|||Participants|||Count of Participants
2528048|NCT03533829|Primary|Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive|Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject|Day1|Participant randomized to intervention and vaccinated. One participant did not complete the assessment.|||Participants|||Count of Participants
2528049|NCT03533829|Primary|Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy|Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject|Day1|Participant randomized to intervention and vaccinated. One participant did not complete the assessment.|||Participants|||Count of Participants
2528051|NCT03533829|Primary|Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy|Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject|Day1|Participant randomized to intervention and vaccinated|||Participants|||Count of Participants
2528052|NCT03533829|Primary|Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive|Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject|Day1|Participant randomized to intervention and vaccinated|||Participants|||Count of Participants
2528053|NCT03533829|Primary|Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy|Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject|Day1|Participant randomized to intervention and vaccinated|||Participants|||Count of Participants
2528054|NCT03533829|Primary|Number of Subjects Who Complete the Acceptability Assessment|Subjects will be given a questionnaire about the acceptability of their intervention.|Day1|Participant randomized to intervention and vaccinated|||Participants|||Count of Participants
2528055|NCT03533829|Primary|Number of Subjects Who Complete the Post Vaccination Anxiety Assessment|Subjects will complete a post vaccination anxiety assessment|Day1|Participant randomized to intervention and vaccinated|||Participants|||Count of Participants
2528056|NCT03533829|Primary|Number of Subjects Who Complete the Post-vaccination Presyncope Symptom Assessment|Subjects will complete a questionnaire about presyncope symptoms after their vaccination/s|Day1|Participants randomized to intervention and vaccinated.|||Participants|||Count of Participants
2528057|NCT03533829|Primary|Number of Subjects Who Complete the Post-vaccination Pain Assessment at 10 Minutes|Subjects will complete a post vaccination pain assessment at 10 minutes after their final vaccination|Day1|Participants randomized to intervention and vaccinated.|||Participants|||Count of Participants
2528058|NCT03533829|Primary|Number of Subjects Who Complete the Post-vaccination Pain Assessment at 1 Minute.|Subjects will complete a post vaccination pain assessment within one minute of their final vaccination|Day1|Participants randomized to intervention and vaccinated.|||Participants|||Count of Participants
2528059|NCT03533829|Primary|Number of Subjects Who Complete the Pre-vaccination Needle Phobia Assessment|Subjects will be asked to complete a needle phobia assessment pre-vaccination|Day1|Participant randomized to intervention and vaccinated|||Participants|||Count of Participants
2528060|NCT03533829|Primary|Number of Subjects Who Complete the Pre-vaccination Anxiety Assessment|Subjects will be asked to complete an anxiety assessment prior to vaccination|Day1|Participants randomized to intervention and vaccinated|||Participants|||Count of Participants
2528061|NCT03533829|Primary|Number of Subjects Who Have Music Playing for 10 Minutes Post Vaccination|Music will be played over speakers through the 10 minute post vaccination pain assessment|Day1|Participants randomized to intervention and vaccinated|||Participants|||Count of Participants
2528062|NCT03533829|Primary|Number of Subjects Who Have Music Playing for ≥ 3 Minutes Prior to Vaccination|Music will be played over speakers for a minimum of 3 minutes prior to vaccination|Day1|Participants randomized to intervention and vaccinated|||Participants|||Count of Participants
2528063|NCT03533829|Primary|Number of Subjects Who Have Buzzy® Kept on Vaccination Arm/s During the Entire Vaccination Procedure|Buzzy® will be applied to and kept on the subjects arm for the duration of the vaccination procedure.|Day1|Participants randomized to intervention and vaccinated|||Participants|||Count of Participants
2528064|NCT03533829|Primary|Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination|Buzzy® will be applied to and kept on the subjects arm for a minimum of 30 seconds prior to vaccination.|Day1|Participants randomized to intervention and vaccinated|||Participants|||Count of Participants
2528065|NCT03533036|Secondary|Change in Procedure Related Anxiety as Assessed by the Visual Analog Scale (VAS).|"Mean change in procedure related anxiety score as assessed by the Visual Analog Scale (VAS).~The Visual Analog Scale is a 11 point scale ranging from 0 to 10. 0 indicates the least amount of discomfort or anxiety whereas 10 represents the most amount of discomfort or anxiety.~Participants were surveyed on their level of discomfort prior to and after the procedure. The difference of these scores was taken and the average of each group is presented in as a result."|30 min||||units on a scale||Standard Deviation|Mean
2528066|NCT03533036|Primary|Number of Participants Able to Use VR Device Throughout the Entire Duration of First Trimester Surgical Abortion.|Number of participants able to use VR device throughout the entire duration of first trimester surgical abortion.|15 minutes||||participants|||Number
2528067|NCT03531905|Other Pre-specified|Number of Participants With Any Treatment-emergent Adverse Event (TEAE)|Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) that began or worsened in severity on or after the first dose of double-blind IMP through 30 days after the last dose of double-blind IMP. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, including control, and which does not necessarily have a causal relationship with treatment. An AE is: any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; any new disease or exacerbation of an existing disease; any deterioration in non-protocol-required measurements of a laboratory value or other clinical test (e.g., electrocardiogram or x-ray) that results in symptoms, a change in treatment, or discontinuation from IMP; or an adverse drug reaction.|up to approximately 16 weeks|Safety Analysis Set: all randomized participants who received at least one dose of IMP|||Participants|||Count of Participants
2528077|NCT03531905|Secondary|Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B)|Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for apo B. Baseline was defined as the last value prior to the first dose of IMP. Percent change from Baseline for TC was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for apo B was imputed using the LOCF method. Percent change from Baseline was calculated as: ([apo B value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For apo B, if a measured apo B value was available, measured apo B was used.|Baseline; Week 12|EAS. Only participants with available data were analyzed.|||Percent change||Standard Error|Least Squares Mean
2528068|NCT03531905|Other Pre-specified|Percent Change From Baseline to Week 12 in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Index|The HOMA-IR index was calculated from the fasting glucose and insulin values that were obtained at each clinic visit (Day 1/Visit T1, Week 4/Visit T2, and Week 12/Visit T3) during the double-blind treatment period, using the formula: (fasting glucose [millimoles per milliliter {mmol/ml}] x fasting insulin [micro International Units per milliliter {μIU/ml}]) divided by 22.5. Percent change from Baseline for HOMA-IR index was analyzed using ANCOVA, with treatment as factor and Baseline HOMA-IR index as a covariate. Baseline was defined as the last value prior to the first dose of study drug (on or before T1). Percent change from Baseline for HOMA-IR index was calculated as: ([HOMA-IR index value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100.|Baseline; Week 12|EAS. Only participants with available data were analyzed.|||Percent change||Standard Error|Least Squares Mean
2528069|NCT03531905|Other Pre-specified|Percent Change From Baseline to Week 12 in 2-hour Post Prandial Plasma Glucose (PPG)|Blood samples were drawn 2 hours ± 5 minutes after the start of the meal. Samples were collected and analyzed for PPG. Baseline was defined as the last value prior to the first dose of study drug (on or before T1). Percent change from Baseline for PPG was calculated as: ([PPG value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For PPG, if a measured PPG value was available, measured PPG was used.|Baseline; Week 12|EAS. Only participants with available data were analyzed.|||Percent change||Standard Deviation|Mean
2528070|NCT03531905|Other Pre-specified|Percent Change From Baseline to Week 12 in Fasting Plasma Glucose|Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for fasting plasma glucose. Baseline was defined as the last value prior to the first dose of study drug (on or before T1). Percent change from Baseline for fasting plasma glucose was analyzed using ANCOVA, with treatment as factor and Baseline fasting plasma glucose as a covariate. Percent change from Baseline for fasting plasma glucose was calculated as: ([fasting plasma glucose value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For fasting plasma glucose, if a measured fasting plasma glucose value was available, measured fasting plasma glucose was used.|Baseline; Week 12|EAS. Only participants with available data were analyzed.|||Percent change||Standard Error|Least Squares Mean
2528071|NCT03531905|Secondary|Percent Change From Baseline to Week 12 in HbA1c|Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for HbA1c. Baseline was defined as the last value prior to the first dose of IMP (on or before Visit T1). Percent change from Baseline for HbA1C was analyzed using ANCOVA, with treatment as factor and Baseline HbA1C value as a covariate. Percent change from Baseline for HbA1c was calculated as: ([HbA1c value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For HbA1c, if a measured HbA1c value was available, measured HbA1c was used.|Baseline; Week 12|EAS. Only participants with available data were analyzed.|||Percent change||Standard Error|Least Squares Mean
2528072|NCT03531905|Secondary|Change From Baseline to Week 12 in Hemoglobin A1C (HbA1c)|Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for HbA1c. Baseline was defined as the last value prior to the first dose of IMP (on or before Visit T1). Change from Baseline was calculated as the HbA1c value at Week 12 minus the Baseline value. For HbA1c, if a measured HbA1c value was available, measured HbA1c was used.|Baseline; Week 12|EAS. Only participants with available data were analyzed.|||mg/dL||Standard Deviation|Mean
2528073|NCT03531905|Secondary|Secondary Outcome Measure: Number of Participants With an LDL-C Reduction of ≥50% From Baseline at Week 12|Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. LDL-C reduction from Baseline was calculated as the LDL-C value at Week 12 minus the Baseline value. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used.|Baseline; Week 12|EAS. Only participants with available data were analyzed.|||Participants|||Count of Participants
2528074|NCT03531905|Secondary|Number of Participants With LDL-C <70 Milligrams Per Deciliter (mg/dL) at Week 12|Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used.|Week 12|EAS. Only participants with available data were analyzed.|||Participants|||Count of Participants
2528075|NCT03531905|Secondary|Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C)|Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for HDL-C. Baseline was defined as the average of HDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for HDL-C was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for HDL-C was imputed using the LOCF method. Percent change from Baseline was calculated as: ([HDL-C value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For HDL-C, if a measured HDL-C value was available, measured HDL-C was used.|Baseline; Week 12|EAS. Only participants with available data were analyzed.|||Percent change||Standard Error|Least Squares Mean
2528076|NCT03531905|Secondary|Percent Change From Baseline to Week 12 in Triglycerides (TGs)|Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for TGs. Baseline was defined as the average of TG values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for TGs was analyzed using a non-parametric approach. Percent change from Baseline was calculated as: ([TG value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For TGs, if a measured TG value was available, measured TG was used.|Baseline; Week 12|EAS. Only participants with available data were analyzed.|||Percent change||Inter-Quartile Range|Median
2528103|NCT03528174|Secondary|Number of Carbohydrate Treatments|Assess the average number of carbohydrate treatments per study defined as 15 or 20 grams of carbohydrates.|up to 10 hours||||carbohydrate treatments||Standard Deviation|Mean
2528104|NCT03528174|Secondary|Mean Sensed Glucose|Assess the average sensor glucose based on the Dexcom G5 CGM sensor values.|up to 10 hours||||mg/dL||Standard Deviation|Mean
2528581|NCT03500159|Secondary|Response to Treatment Compared to Placebo at Week 12 as Measured by the GRA|AQX-1125 200 mg compared to placebo as measured by the Global Response Assessment (GRA) at Week 12|12 Weeks|||||||
2528078|NCT03531905|Secondary|Percent Change From Baseline to Week 12 in Total Cholesterol (TC)|Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the average of TC values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for TC was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for TC was imputed using the LOCF method. Percent change from Baseline was calculated as: ([TC value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For TC, if a measured TC value was available, measured TC was used.|Baseline; Week 12|EAS. Only participants with available data were analyzed.|||Percent change||Standard Error|Least Squares Mean
2528079|NCT03531905|Secondary|Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)|Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for non-HDL-C. Baseline was defined as the average of non-HDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for non-HDL-C was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for non-HDL-C was imputed using the LOCF method. Percent change from Baseline was calculated as: ([non-HDL-C value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For non-HDL-C, if a measured non-HDL-C value was available, measured non-HDL-C was used.|Baseline; Week 12|EAS. Only participants with available data were analyzed.|||Percent change||Standard Error|Least Squares Mean
2528080|NCT03531905|Secondary|Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)|Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the last value prior to the first dose of investigational medicinal product (IMP). Percent change from Baseline for hsCRP was analyzed using a non-parametric approach. Percent change from Baseline was calculated as: ([hsCRP value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For hsCRP, if a measured hsCRP value was available, measured hsCRP was used.|Baseline; Week 12|EAS. Only participants with available data were analyzed.|||Percent change||Inter-Quartile Range|Median
2528081|NCT03531905|Secondary|Percent Change From Baseline to Week 12/EOS in LDL-C (Comparing Ezetimibe With Placebo)|Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at Visit S3 and Visit T1 (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for LDL-C was analyzed using ANCOVA, with treatment as factor and Baseline lipid parameter as a covariate. Missing data for LDL-C was imputed using the LOCF method. Percent change from Baseline was calculated as: ([LDL-C value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used.|Baseline; Week 12|EAS. Only participants with available data were analyzed.|||Percent change||Standard Error|Least Squares Mean
2528082|NCT03531905|Primary|Percent Change From Baseline to Week 12/End of Study (EOS) in Low-density Lipoprotein Cholesterol (LDL-C)|Blood samples were drawn after a minimum 10-hour fast at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the average of LDL-C values at the Screening Visit 3 (Visit S3) and the Treatment Visit 1 (Visit T1) (last 2 non-missing values on or prior to Day 1). If only 1 value was available, the single value was used as Baseline. Percent change from Baseline for LDL-C was analyzed using analysis of covariance (ANCOVA), with treatment as factor and Baseline lipid parameter as a covariate. Missing data for LDL-C was imputed using the last observation carried forward (LOCF) method. Percent change from Baseline was calculated as: ([LDL-C value at Week 12 minus Baseline value] divided by [Baseline value]) multiplied by 100. For LDL-C, if a measured LDL-C value was available, measured LDL-C was used.|Baseline; Week 12|Efficacy Analysis Set (EAS): all randomized participants who received at least one dose of investigational medicinal product (Full Analysis Set), excluding participants at three study sites. Only participants with available data were analyzed.|||Percent change||Standard Error|Geometric Least Squares Mean
2528083|NCT03530631|Primary|Number of Participants Consistently Attending and Completing Four Neuroimaging Sessions|Using a balanced placebo design, participants were either administered mixed amphetamine salts or placebo. Their cognitive performance was assessed in the MRI scanner. The main outcome measure was the feasibility of participants attending four neuroimaging sessions.|A total of 4 imagining sessions, an average of 60 minutes each||||Participants|||Count of Participants
2528084|NCT03529461|Secondary|Percentage of Participants in the Control Group With an Oxygen Saturation Less Than 90 % Who Responded to Rescue NIPPV|We used non-invasive positive pressure ventilation (NIPPV) as a first rescue maneuver in control patients who developed an oxygen desaturation less than 90 % and reported on the percentage of participants who responded. The rescue was considered successful with recovery of oxygen saturation more than 90 % within 3 minutes.|3 minutes following a desaturation event < 90 %|We report on the response of 8 participants in the control group who had an oxygen desaturation event less than 90 %|||Participants|||Count of Participants
2528085|NCT03529461|Primary|Percentage of Participants With an Oxygen Desaturation Event < 90%|Percentage of participants who develop a peripheral oxygen saturation event < 90%.|Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).||||percentage of participants|||Number
2528086|NCT03529461|Primary|Percentage of Participants With an Oxygen Desaturation Event ≤ 94%|Percentage of participants who develop a peripheral oxygen saturation measured by pulse oximetry ≤ 94%|Time in seconds beginning with the start of procedure (anesthesia induction) ending with procedure completion (eyes open to verbal stimuli).||||percentage of participants|||Number
2528105|NCT03528174|Secondary|Percent of Time With Sensed Glucose Greater Than 250 mg/dl|Assess the percent of time with sensed glucose greater than 250 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.|up to 10 hours||||percentage of time||Standard Deviation|Mean
2528106|NCT03528174|Secondary|Percent of Time With Sensed Glucose Less Than 54 mg/dl|Assess the percent of time with sensed glucose less than 54 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.|up to 10 hours||||percentage of time||Standard Deviation|Mean
2536686|NCT03159299|Secondary|Change in Dietary Intake From Baseline|Dietary intake will be evaluated by a two-day diet history|3 months|||||||
2528087|NCT03528369|Post-Hoc|Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Total Scores (Pain, Stiffness and Function).|"Day 5, 19, 35, 64 and 94 Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index total scores (pain, stiffness and function) from Baseline.~The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score is 24 questions relating to pain, stiffness and physical function that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 2400. Positive numbers indicate increases and negative numbers indicate decreases."|Day 5, 19, 35, 64 and 94 days after the last dose of study drug on Study Day 4|All subjects that received at least one dose of study drug and had at least one evaluable post-dosing efficacy endpoint. Differences in number of subjects is due to subjects early withdrawal from the study.|||units on a scale||Full Range|Mean
2528088|NCT03528369|Other Pre-specified|Number of Subjects With Durability of Efficacy Response|Subjects who had a clinical response (i.e., reduction of at least 50% in WOMAC pain score) at the Day 5 visit and who remained at this reduction of pain score or lower at Days 19, 35, 64, and the Day 94 visit were considered to have a durable clinical response through Day 94. Subjects who had a clinical response at no more than one of the post Day 5 visits were considered to have a durable response through the last day at which reduction in WOMAC pain score is at least 50%. Subjects who had less than 50% WOMAC pain score reduction on two or more of the post Day 5 visits were considered to have failed to achieve a durable clinical response.|Days 35, 64 and 94 day after the last dose of study drug on Study Day 4|All subjects that received at least one dose of study drug and had at least one evaluable post-dosing efficacy endpoint.|||Participants|||Count of Participants
2528089|NCT03528369|Other Pre-specified|Number of Subjects With Skin Reactions of Erythema or Pruritus.|Investigator reports of erythema or pruritus at the site of study drug application.|Study Day 1 through Study Day 35 after the first application of study drug (Study Day 1)|All subjects who have received at least one dose of study drug|||participants|||Number
2528090|NCT03528369|Secondary|Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Function Scores.|"Day 5, 19, 35, 64 and 94 Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Function Scores.~The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function score is 17 questions relating to physical function that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 1700. Positive numbers indicate increases and negative numbers indicate decreases."|Day 5, 19, 35, 64 and 94 days after the last dose of study drug on Study Day 4|All subjects that received at least one dose of study drug and had at least one evaluable post-dosing efficacy endpoint. Differences in number of subjects is due to subjects early withdrawal from the study.|||units on a scale||Full Range|Mean
2528091|NCT03528369|Secondary|Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Stiffness Scores.|"Day 5, 19, 35, 64 and 94 Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index Stiffness Scores.~The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score is 2 questions relating to stiffness that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 200. Positive numbers indicate increases and negative numbers indicate decreases."|Day 5, 19, 35, 64 and 94 days after the last dose of study drug on Study Day 4|All subjects that received at least one dose of study drug and had at least one evaluable post-dosing efficacy endpoint. Differences in number of subjects is due to subjects early withdrawal from the study.|||units on a scale||Full Range|Mean
2528092|NCT03528369|Secondary|Patient Reported Burning-Stinging Pain (BSP) During Application of Study Drug.|The average amount of burning-sting pain as reported by the subject using a 0 - 10 numerical rating scale (NRS). Higher scores indicate more pain.|60 minutes after study drug application on Study Days 1,2,3,4|All subjects who have received at least one dose of study drug. The number of subjects analyzed differs in some cases due to missing data.|||units on a scale||Full Range|Mean
2528093|NCT03528369|Secondary|Secondary Efficacy Endpoint #1: Extent of Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score From Baseline to Day 5, 19, 64 and 94.|"The extent of change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score, relative to baseline, provided by once daily, one-hour application of CGS-200-0, CGS-200-1 and CGS-200-5 from Baseline to Day 5, 19, 64 and Day 94.~The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score is 5 questions relating to pain that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 500. Positive numbers indicate increases and negative numbers indicate decreases."|Days 5, 19, 65 and 94 after the last dose of study drug on Day 4|All subjects who received at least one dose of study drug. Differences in subjects is due to subjects who withdrew from the study prior to the efficacy assessment.|||units on a scale||Full Range|Mean
2528094|NCT03528369|Primary|Primary Efficacy Endpoint: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score From Baseline to Day 35|"The Primary Efficacy endpoint of this study will be to examine the extent of change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score, relative to baseline, provided by once daily, one-hour application of Vehicle (CGS-200-0), CGS-200-1 and CGS-200-5 at Baseline (< 30 minutes prior to first daily application) and Day 35 (31 days after fourth daily application).~The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score is 5 questions relating to pain that the subject responds to using a 100mm visual analogue scale. The minimum score is 0 and the maximum score is 500. Reduction in pain is expressed as a difference from baseline to Study Day 35. Positive numbers indicate increases and negative numbers indicate decreases. ."|35 days after the last dose of study drug on Day 4|All subjects that received at least one dose of study drug and had at least one evaluable post-dosing efficacy endpoint.|||units on a scale||Full Range|Mean
2528107|NCT03528174|Secondary|Percent of Time With Sensed Glucose Less Than 70 mg/dl|Assess the percent of time with sensed glucose less than 70 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.|up to 10 hours||||percentage of time||Standard Deviation|Mean
2528108|NCT03528174|Secondary|Percent of Time With Sensed Glucose Between 70-180 mg/dl|Assess the percent of time with sensed glucose between 70-180 mg/dl based on the Dexcom G5 CGM sensor values for all subjects.|up to 10 hours||||percentage of time||Standard Deviation|Mean
2528109|NCT03528174|Primary|Mean Absolute Relative Difference of Sensed Glucose Values|Assess the mean absolute relative difference for the PDT CGM/insulin infusion system based on all reference YSI venous blood glucose values.|up to 10 hours||||percentage of reference blood glucose||Standard Deviation|Mean
2528095|NCT03528174|Secondary|Mean Draize Scale for Edema for the Left Sensing Cannula at End of Study for All Subjects|Assess the average score on the Draize scale at the end of the study of the PDT glucose sensor. The investigator discharging the subject will inspect each PDT glucose sensing cannula insertion site and rate the level of redness (erythema) and swelling (edema). Both the left and right insertion sites will be inspected. Erythema will be measured from 0-4. A score of 0 indicates no erythema, a score of 1 indicates very slight, barely perceptible erythema, a score of 2 indicates well defined erythema, a score of 3 indicates moderate erythema, and a score of 4 indicates severe erythema, beet redness to slight eschar formation. Edema will be measured from a score of 0-4. A score of 0 indicates no edema, a score of 1 indicates very slight, barely perceptible edema, a score of 2 indicates well defined edema, a score of 3 indicates moderate edema, raised approximately 1 mm, and a score of 4 indicates severe edema, raised greater than 1 mm and beyond exposure area.|end of 10 hour study||||units on a scale||Standard Deviation|Mean
2528096|NCT03528174|Secondary|Mean Draize Scale for Erythema for the Right Sensing Cannula at End of Study for All Subjects|Assess the average score on the Draize scale at the end of the study of the PDT glucose sensor. The investigator discharging the subject will inspect each PDT glucose sensing cannula insertion site and rate the level of redness (erythema) and swelling (edema). Both the left and right insertion sites will be inspected. Erythema will be measured from 0-4. A score of 0 indicates no erythema, a score of 1 indicates very slight, barely perceptible erythema, a score of 2 indicates well defined erythema, a score of 3 indicates moderate erythema, and a score of 4 indicates severe erythema, beet redness to slight eschar formation. Edema will be measured from a score of 0-4. A score of 0 indicates no edema, a score of 1 indicates very slight, barely perceptible edema, a score of 2 indicates well defined edema, a score of 3 indicates moderate edema, raised approximately 1 mm, and a score of 4 indicates severe edema, raised greater than 1 mm and beyond exposure area.|End of 10 hour study||||units on a scale||Standard Deviation|Mean
2528097|NCT03528174|Secondary|Mean Draize Scale for Edema for the Left Sensing Cannula at End of Study for All Subjects|Assess the average score on the Draize scale at the end of the study of the PDT glucose sensor. The investigator discharging the subject will inspect each PDT glucose sensing cannula insertion site and rate the level of redness (erythema) and swelling (edema). Both the left and right insertion sites will be inspected. Erythema will be measured from 0-4. A score of 0 indicates no erythema, a score of 1 indicates very slight, barely perceptible erythema, a score of 2 indicates well defined erythema, a score of 3 indicates moderate erythema, and a score of 4 indicates severe erythema, beet redness to slight eschar formation. Edema will be measured from a score of 0-4. A score of 0 indicates no edema, a score of 1 indicates very slight, barely perceptible edema, a score of 2 indicates well defined edema, a score of 3 indicates moderate edema, raised approximately 1 mm, and a score of 4 indicates severe edema, raised greater than 1 mm and beyond exposure area.|end of 10 hour study||||units on a scale||Standard Deviation|Mean
2528098|NCT03528174|Secondary|Mean Draize Scale for Erythema for the Left Sensing Cannula at End of Study for All Subjects|Assess the average score on the Draize scale at the end of the study of the PDT glucose sensor. The investigator discharging the subject will inspect each PDT glucose sensing cannula insertion site and rate the level of redness (erythema) and swelling (edema). Both the left and right insertion sites will be inspected. Erythema will be measured from 0-4. A score of 0 indicates no erythema, a score of 1 indicates very slight, barely perceptible erythema, a score of 2 indicates well defined erythema, a score of 3 indicates moderate erythema, and a score of 4 indicates severe erythema, beet redness to slight eschar formation. Edema will be measured from a score of 0-4. A score of 0 indicates no edema, a score of 1 indicates very slight, barely perceptible edema, a score of 2 indicates well defined edema, a score of 3 indicates moderate edema, raised approximately 1 mm, and a score of 4 indicates severe edema, raised greater than 1 mm and beyond exposure area.|End of 10 hour study||||units on a scale||Standard Deviation|Mean
2528099|NCT03528174|Secondary|Mean Score of Visual Analog Scale at End of Study|Assess the average score on the visual analog scale at the end of the study. This scale will be used to measure sensor site discomfort from the PDT glucose sensing cannula. The subject completes the visual analog scale by drawing a single vertical line through a 100 mm line corresponding to the perceived intensity (severity) of discomfort since the devices were inserted. Subjects will be instructed to mark their line starting on the left side to the right side. If subjects are feeling no discomfort, they would circle the vertical line on the left end of the scale. If subjects are currently feeling the worst discomfort possible, they would circle the vertical line on the right side of the scale. One staff member will measure all scales and document score as a measurement of 0-100.|End of 10 hour study||||mm||Standard Deviation|Mean
2528100|NCT03528174|Secondary|Mean Score of Visual Analog Scale at 120 Minutes|Assess the average score on the visual analog scale at 120 minutes after insertion of the PDT glucose sensor.This scale will be used to measure sensor site discomfort from the PDT glucose sensing cannula. The subject completes the visual analog scale by drawing a single vertical line through a 100 mm line corresponding to the perceived intensity (severity) of discomfort since the devices were inserted. Subjects will be instructed to mark their line starting on the left side to the right side. If subjects are feeling no discomfort, they would circle the vertical line on the left end of the scale. If subjects are currently feeling the worst discomfort possible, they would circle the vertical line on the right side of the scale. One staff member will measure all scales and document score as a measurement of 0-100.|120 minutes post insertion||||mm||Standard Deviation|Mean
2528101|NCT03528174|Secondary|Mean Score of Visual Analog Scale at 15 Minutes|Assess the average score on the visual analog scale at 15 minutes after insertion of the PDT glucose sensor. This scale will be used to measure sensor site discomfort from the PDT glucose sensing cannula. The subject completes the visual analog scale by drawing a single vertical line through a 100 mm line corresponding to the perceived intensity (severity) of discomfort from the insertion of the sensors. Subjects will be instructed to mark their line starting on the left side over to the right side. If subjects are feeling no discomfort, they would circle the vertical line on the left end of the scale. If subjects are currently feeling the worst discomfort possible, they would circle the vertical line on the right side of the scale. One staff member will measure all scales and document score as a measurement of 0-100.|15 minutes post insertion||||mm||Standard Deviation|Mean
2528102|NCT03528174|Secondary|Mean Amount of Insulin Delivered|Assess the average amount of insulin delivered per study in units/kg.|up to 10 hours||||units/kg||Standard Deviation|Mean
2536687|NCT03159299|Secondary|Dietary Intake|Dietary intake will be evaluated by a two-day diet history|Baseline|||||||
2528113|NCT03527966|Primary|Mean Oswestry Disability Index (ODI) Score|The ODI is one of the most commonly utilized condition-specific measures of disability used in the management of spinal disorders (0-no disability, to 100-maximum disability possible)|Up to 1 year post surgery|Patients did not attend every follow up visit and then were ultimately lost to follow up. Study was also terminated early when the PI left his practice so on patients were never randomized in the control group.|||score on a scale||Full Range|Mean
2528114|NCT03526055|Secondary|Rate of AEs|Rate of device-related and/or procedure-related AEs|From spinal cord stimulation implant through study completion or study exit, Up to 8 days|10 patients total, crossover design|||participants experienced AE|||Number
2528115|NCT03526055|Secondary|Achievement of ≥50% Pain Relief|Number of patients who achieved ≥ 50% pain relief during the trial (from either arm). The study used a pain relief scale (similar to a brief pain inventory). The scale assessed pain relief using a percent relief rating in 10% increments, where a higher number represents greater pain relief than a lower number for the pain scale. A higher number is considered better for pain relief scale.|Up to 8 days|10 patients in total, crossover design.|||Participants|||Count of Participants
2528116|NCT03526055|Secondary|Subject Satisfaction|Subjects will be asked to rate their overall satisfaction with the pain relief achieved during the trial (from either arm) using the following scale; Very Satisfied, Satisfied, Neither Satisfied nor Unsatisfied, Unsatisfied or Very Unsatisfied|Up to 8 days|This information was not collected.||||||
2528117|NCT03526055|Secondary|Quality of Pain Relief|Subjects will be asked to rate the quality of the pain relief achieved during the trial (from either arm) using the following scale; Excellent, Very Good, Good, Fair or Poor|Up to 8 days|This information was not collected.||||||
2528118|NCT03526055|Secondary|Subject Preference|Subjects will be asked to select their favorite program|Up to 8 days|1 subject preferred both programs equally.|||Participants|||Count of Participants
2528119|NCT03526055|Secondary|Distribution of Paresthesia|1. At end of each arm, subjects will be asked to complete a diagram that shows distribution of paresthesia.|Up to 8 days|This information was not collected.||||||
2528120|NCT03526055|Primary|Subject Pain Relief|The study used a pain relief scale (similar to a brief pain inventory). The scale assessed pain relief using a percent relief rating in 10% increments, where a higher number represents greater pain relief than a lower number for the pain scale. A higher number is considered better for pain relief scale. The scale range is from 0%, which is no relief of pain to 100%, which is complete relief of pain. Subjects are asked to rate their pain by marking the box beside the number that best describes their pain in the last 24 hours.|up to 8 days||||percentage of pain relief||Full Range|Mean
2528121|NCT03525678|Secondary|Change From Baseline in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score|The EORTC QLQ-MY20 is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. The module comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (DS), side effects of treatment (SET), future perspective (FP) and body image (BI). Responses are 1 to 4. Scores were averaged and scales were transformed to 0 to 100 scale. A high score for disease symptoms and side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective and body image represented better outcomes. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1) and Week 07, Week 13, Week 19, Week 25, Week 31, Week 37 and Week 43|Full Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2528122|NCT03525678|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score|The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning [PF], role functioning [RF], cognitive functioning [CF], emotional functioning [EF] and social functioning [SF]), three symptom scales (fatigue, pain and nausea/vomiting [N/V]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss [AL] and financial difficulties [FD]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1) and Week 07, Week 13, Week 19, Week 25, Week 31, Week 37 and Week 43|Full Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2528123|NCT03525678|Secondary|Worst Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score|The OSDI is a 12-item questionnaire designed to assess both the frequency of dry eye symptoms and their impact on vision-related functioning. The total OSDI score was calculated as (sum of scores for all questions answered*100) divided by (total number of questions answered*4). Domain scores ranged from 0 to 100; lower scores are better. Therefore, decrease in score from Baseline means improvement. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for worst-case post Baseline is presented.|Baseline (Day 1) and up to Week 48|Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2528132|NCT03525678|Secondary|AUC(0-tau) of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM|Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.|Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)|Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2528124|NCT03525678|Secondary|Worst Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Score|The NEI-VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question to assess the impact of ocular toxicity on visual function. Items were coded to a 0 to 100 scale and averaged to calculate domains. Domain scores ranged from 0 to 100; higher scores are better. Therefore, increase in score means improvement. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for worst-case post Baseline is presented.|Baseline (Day 1) and up to Week 48|Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2528125|NCT03525678|Secondary|Number of Participants With Symptomatic AEs Measured by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)|The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. It included symptomatic toxicities drawn from the CTCAE like blurred vision (BV), chills, constipation, decreased appetite (DA), fatigue, general pain (GP), heart palpitations (HP), mouth/throat (M/T) sores, nausea, nosebleed, shortness of breath (SB), vomiting and watery eyes (WE). Items were scored individually on a 0 to 4 scale for severity, frequency and interference. Number of participants with symptomatic AEs (those who had a maximum post-Baseline rating greater than 0, example; 1, 2, 3, or 4) measured by PRO-CTCAE are presented.|Up to 48 weeks|Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.|||Participants|||Count of Participants
2528126|NCT03525678|Secondary|Titers of Anti-drug Antibodies Against GSK2857916|Serum samples were collected for the determination of ADA using a validated ECL immunoassay. The assay involved screening, confirmation and titration steps. If serum samples contained ADA, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive samples were titrated to obtain the titers of antibodies. Titers of anti-drug antibodies against GSK2857916 is presented. No participant was found with positive results for ADA test in arms; GSK2857916 3.4 mg/kg (Frozen liquid) and GSK2857916 3.4 mg/kg (Lyophilized). Hence, titer values are not presented for both these arms.|Up to 48 weeks|Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.|||Titers||Standard Deviation|Mean
2528127|NCT03525678|Secondary|Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-drug Antibody (ADA) Result|Serum samples were collected for the determination of anti-GSK2857916 antibodies (ADA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.|Up to 48 weeks|Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.|||Participants|||Count of Participants
2528128|NCT03525678|Secondary|t1/2 of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM|Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.|Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)|Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Hours||Geometric Coefficient of Variation|Geometric Mean
2528129|NCT03525678|Secondary|Tmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM|Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.|Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)|Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Hours||Full Range|Median
2528130|NCT03525678|Secondary|Cmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With RRMM|Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.|Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)|Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2528131|NCT03525678|Secondary|AUC(0-tlast) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM|Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.|Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)|Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2528272|NCT03519919|Secondary|Overall Satisfaction Preference Between Study and Habitual Contact Lenses|Subjective satisfaction preference between study and habitual contact lenses (Fell short of expectations, Met ,my expectations, Exceeded my expectations))|3 weeks||||percentage of participants|||Number
2528133|NCT03525678|Secondary|AUC(0-infinity) of Cysteine-maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With RRMM|Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.|Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)|Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2528134|NCT03525678|Secondary|t1/2 of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.|Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)|Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Hours||Geometric Coefficient of Variation|Geometric Mean
2528135|NCT03525678|Secondary|Tmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.|Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)|Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Hours||Full Range|Median
2528136|NCT03525678|Secondary|Cmax of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.|Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)|Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2528137|NCT03525678|Secondary|AUC(0-tlast) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.|Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)|Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2528138|NCT03525678|Secondary|AUC(0-tau) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.|Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)|Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2528139|NCT03525678|Secondary|AUC(0-infinity) of GSK2857916 Total Antibody Following IV Dose in Participants With RRMM|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 total antibody were calculated using non-compartmental methods.|Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)|Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2528140|NCT03525678|Secondary|Terminal Half-life (t1/2) of GSK2857916 Following IV Dose in Participants With RRMM|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.|Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)|Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Hours||Geometric Coefficient of Variation|Geometric Mean
2528141|NCT03525678|Secondary|Time to Reach Maximum Observed Concentration (Tmax) of GSK2857916 Following IV Dose in Participants With RRMM|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.|Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)|Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Hours||Full Range|Median
2528142|NCT03525678|Secondary|Maximum Observed Concentration (Cmax) of GSK2857916 Following IV Dose in Participants With RRMM|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.|Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)|Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2528273|NCT03519919|Secondary|Overall Satisfaction Preference Between Study and Habitual Contact Lenses|Subjective satisfaction preference of contact lens between study and habitual contact lenses(Fell short of expectations, Met my expectation, Exceeded my expectation)|Baseline||||percentage of participants|||Number
2528143|NCT03525678|Secondary|Area Under the Concentration-time Curve From Zero to Time of Last Quantifiable Concentration (AUC[0-tlast]) of GSK2857916 Following IV Dose in Participants With RRMM|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.|Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)|Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2528144|NCT03525678|Secondary|Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK2857916 Following IV Dose in Participants With RRMM|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.|Cycle 1 and Cycle 3: Pre-dose, EOI, 2 hours and 24 hours post SOI on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)|Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2528145|NCT03525678|Secondary|Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of GSK2857916 Following IV Dose in Participants With RRMM|Blood samples were collected at designated timepoints. Pharmacokinetic (PK) parameters of GSK2857916 were calculated using non-compartmental methods. Full Pharmacokinetic (PK) Population comprised of all participants in the Full Safety Population who had atleast 1 non-missing PK assessment.|Cycle 1 and Cycle 3: Pre-dose, end of infusion (EOI), 2 hours and 24 hours post start of infusion (SOI) on Day 1, anytime on Day 4, and anytime on Day 8 to Day 15 (each cycle of 21 days)|Full PK Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2528146|NCT03525678|Secondary|Number of Participants With Shift in Tear Break-up Time From >10 Seconds (Baseline) to <=5 Seconds (Worst Post-Baseline)|Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with shift in tear break-up time from >10 seconds (Baseline) to <=5 seconds (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.|Baseline and Up to 48 weeks|Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2528147|NCT03525678|Secondary|Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)|Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Corneal epithelium findings like active edema, active opacity, corneal neovascularization (CN), corneal ulcer, epithelial microcystic edema (EME) and subepithelial were performed using a slit lamp. Number of participants with shift in corneal epithelium findings from no (Baseline) to yes (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.|Baseline and Up to 48 weeks|Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2528148|NCT03525678|Secondary|Number of Participants With Shift in Corneal Epithelium Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline) for Corneal Epithelium (CE) and Corneal Stroma (CS)|Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Corneal epithelium findings for CE and CS were assessed individually for each eye. Number of participants with shift in corneal epithelium findings from normal (Baseline) to abnormal (worst post-Baseline) for CE and CS are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.|Baseline and Up to 48 weeks|Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2528149|NCT03525678|Secondary|Number of Participants With Shift in Extraocular Muscle Movement From Yes (Baseline) to no (Worst Post-Baseline)|Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Extraocular muscle movement was assessed individually for each eye. Number of participants with shift in extraocular muscle movement from yes (Baseline) to no (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.|Baseline and Up to 48 weeks|Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2528150|NCT03525678|Secondary|Number of Participants With Shift in Pupillary Examination Findings From Normal (Baseline) to Abnormal (Worst Post-Baseline)|Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with shift in pupillary examination findings from normal (Baseline) to abnormal (worst post-Baseline) are presented.|Baseline and Up to 48 weeks|Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.|||Participants|||Count of Participants
2528166|NCT03525678|Secondary|Progression Free Survival by Investigator Assessment|Progression free survival is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to any cause. Progression free survival based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of progression free survival are presented.|Up to 48 weeks|Full Analysis Population|||Months||Inter-Quartile Range|Median
2528151|NCT03525678|Secondary|Number of Participants With Intraocular Pressure (IOP) >=22 mmHg Anytime Post-Baseline|Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. IOP was assessed individually for each eye. Number of participants with IOP >=22 mmHg anytime post-Baseline are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.|Up to 48 weeks|Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2528152|NCT03525678|Secondary|Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores|Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. BCVA score was assessed individually for each eye. BCVA test scores were categorized as no change/improved vision, possible worsened vision and definite worsened vision. No change/improved vision was defined as a change from Baseline <0.12 Logarithm of the Minimum Angle of Resolution (logMAR) score; a possible worsened vision was defined as a change from Baseline >=0.12 to <0.3 logMAR score; a definite worsened vision was defined as a change from Baseline >=0.3 logMAR score. Data for worst-case change from Baseline is presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.|Baseline (Day 1) and Up to 48 weeks|Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2528153|NCT03525678|Secondary|Number of Participants With Serious Adverse Events (SAEs), Common (>=5%) Non-serious Adverse Events and Adverse Events of Special Interest (AESI)|An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Number of participants who had SAEs and common (>=5%) non-SAEs are presented. Number of participants with AESI (keratopathy, dry eye events, blurred vision, thrombocytopenia, infusion-related reactions, corneal events and neutropenia) are also presented.|Up to 48 weeks|Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.|||Participants|||Count of Participants
2528154|NCT03525678|Secondary|Number of Participants With Grade Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were graded using NCI CTCAE version 4.03. For SBP: Grade 0: <120 millimeter mercury (mmHg); Grade 1: 120-139 mmHg; Grade 2: 140-159 mmHg; Grade 3: >=160 mmHg. For DBP: Grade 0: <80 mmHg; Grade 1: 80-89 mmHg; Grade 2: 90-99 mmHg; Grade 3: >=100 mmHg. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with increase to grade 2 and increase to grade 3 have been presented.|Baseline (Day 1) and Up to 48 weeks|Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.|||Participants|||Count of Participants
2528155|NCT03525678|Secondary|Number of Participants With Change From Baseline in Body Temperature|Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case change from Baseline in body temperature are presented. Data is categorized as: body temperature 'decrease to <=35 degrees celsius', 'increase to >=38 degrees celsius' and 'change to normal or no change'. If values were unchanged (example: increase to >=38 to increase to >=38 degrees celsius), or whose value became normal, were recorded in the 'change to normal or no change' category. Participants were counted twice if the participant had both 'decreased to <=35' and 'increased to >=38 degrees celsius' during post Baseline. Data for worst-case post Baseline is presented.|Baseline (Day 1) and Up to 48 weeks|Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.|||Participants|||Count of Participants
2528156|NCT03525678|Secondary|Number of Participants With Change From Baseline in Pulse Rate|Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case change from Baseline in pulse rate is presented. Data is categorized as: pulse rate 'decrease to <60 beats per minute [bpm]', 'increase to >100 bpm' and 'change to normal or no change'. If values were unchanged (example: increase to >100 bpm to increase to >100 bpm), or whose value became normal, were recorded in the 'change to normal or no change' category. Participants were counted twice if the participant had both 'decreased to <60 bpm' and 'increased to >100 bpm' during post Baseline. Data for worst-case post Baseline is presented.|Baseline (Day 1) and Up to 48 weeks|Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.|||Participants|||Count of Participants
2528157|NCT03525678|Secondary|Number of Participants With Abnormal Findings During Physical Examination|Physical examination included assessment of the head, eyes, ears, nose, throat, skin, thyroid, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes, and extremities. This analysis was planned, but data was not collected and captured in the database.|Up to 48 weeks|Full Safety Population. This analysis was planned, but data was not collected and captured in the database.||||||
2528167|NCT03525678|Secondary|Time to Response by Independent Review Committee (Efficacy Population)|Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.|Up to 48 weeks|Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population. Only those participants with data available at the specified data points were analyzed.|||Months||Inter-Quartile Range|Median
2528299|NCT03519919|Secondary|Number of Participants With Lens Centration|Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (>=0.5mm))|Baseline||||Participants|||Count of Participants
2528158|NCT03525678|Secondary|Number of Participants With Grade Change From Baseline in Clinical Chemistry Parameters|Blood samples were collected for analysis of clinical chemistry parameters: glucose(Gl), albumin, alkaline phosphatase (ALP), alanine aminotransferase(ALT), aspartate aminotransferase(AST), total bilirubin(T.Bil), creatinine kinase (CK), creatinine, gamma glutamyl transferase (GGT), potassium (Pot), magnesium (Mg), sodium (Sod), phosphate (Ph) and urate. Values (Hyper and hypo) for Gl, Pot, Mg and Sod is presented. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade1: mild; Grade2: moderate; Grade3: severe or medically significant; Grade4: life-threatening consequences. Baseline is latest pre-dose assessment(Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case PB is presented. Only those participants with increase to grade3 and increase to grade4 have been presented. 3 out of 221participants did not receive any study treatment, were excluded from FSP.|Baseline (Day 1) and Up to 48 weeks|Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2528159|NCT03525678|Secondary|Number of Participants With Change From Baseline in Clinical Chemistry Parameters With Respect to the Normal Range|Blood samples were collected for analysis of clinical chemistry parameters: bicarbonate, direct bilirubin(D.Bil), calcium, chloride, lactate dehydrogenase(LDH), total protein, urea or blood urea nitrogen(BUN),estimated glomerular filtration rate (eGFR).Baseline is latest pre-dose assessment(Day 1) with a non-missing value, including unscheduled visits. Number of participants with worst case clinical chemistry change from Baseline with respect to normal range are presented. Data was categorized as decrease to low (value below the lower LNR), increase to high (value above the upper LNR) and change to normal or NC. If values were unchanged (example: high to high), or whose value became normal, were recorded in the change to normal or NC category. Participants were counted twice if the participant had both decreased to low and increased to high during post Baseline. 3 out of 221participants did not receive any study treatment, were excluded from FSP.|Baseline (Day 1) and Up to 48 weeks|Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2528160|NCT03525678|Secondary|Number of Participants With Grade Change From Baseline in Hematology Parameters|Blood samples were collected for the analysis of following hematology parameters: hemoglobin (Hb), lymphocyte count (Lymph), neutrophil count (Neutro), platelet count (PC), and leukocyte count (leuko). The laboratory parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with increase to grade 3 and increase to grade 4 have been presented.|Baseline (Day 1) and Up to 48 weeks|Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.|||Participants|||Count of Participants
2528161|NCT03525678|Secondary|Number of Participants With Change From Baseline in Hematology Parameters With Respect to the Normal Range|Following parameters were assessed:basophils(Baso),eosinophils(Eosino),hematocrit(Hct),mean corpuscular hemoglobin(MCH),MCH concentration(MCHC),MC volume(MCV),monocyte(Mono),erythrocytes(Erythro),reticulocytes(Reticu).Baseline is latest pre-dose assessment(Day1)with a non-missing value, including unscheduled visits.Data was categorized as decrease to low(value below lower limit of normal range[LNR]),increase to high(value above upper LNR),change to normal/no change(NC).If values were unchanged(eg.high to high) or whose value became normal,were recorded in change to normal/NC category.Participants were counted twice if participant had both decreased to low/increased to high during post-Baseline(PB).Data for worst case PB is presented.Full Safety Population(FSP) comprised of all participants who received at least 1dose of study drug(frozen liquid or lyophilized powder). 3 out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.|Baseline (Day 1) and Up to 48 weeks|Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2528162|NCT03525678|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause. Overall survival was analyzed using the Kaplan-Meier method by dose level. Median and inter-quartile range (first quartile and third quartile) of overall survival are presented.|Up to 48 weeks|Full Analysis Population|||Months||Inter-Quartile Range|Median
2528163|NCT03525678|Secondary|Time to Progression by Independent Review Committee|Time to progression is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to PD. Time to Progression based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to progression are presented.|Up to 48 weeks|Full Analysis Population|||Months||Inter-Quartile Range|Median
2528164|NCT03525678|Secondary|Time to Progression by Investigator Assessment|Time to progression is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to PD. Time to Progression based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of time to progression are presented.|Up to 48 weeks|Full Analysis Population|||Months||Inter-Quartile Range|Median
2528165|NCT03525678|Secondary|Progression Free Survival by Independent Review Committee|Progression free survival is defined as the time from randomization until the earliest date of documented PD per IMWG, or death due to any cause. Progression free survival based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of progression free survival are presented.|Up to 48 weeks|Full Analysis Population|||Months||Inter-Quartile Range|Median
2528221|NCT03522350|Primary|Number of Day 5 Embryos|Comparing the number pf embryos that developed at Day 5 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+|Day 5 post retrieval||||embryos|embryos||Count of Units
2528168|NCT03525678|Secondary|Time to Response by Independent Review Committee (Full Analysis Population)|Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.|Up to 48 weeks|Full Analysis Population. Only those participants with data available at the specified data points were analyzed.|||Months||Inter-Quartile Range|Median
2528169|NCT03525678|Secondary|Time to Response by Investigator Assessment (Efficacy Population)|Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.|Up to 48 weeks|Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population. Only those participants with data available at the specified data points were analyzed.|||Months||Inter-Quartile Range|Median
2528170|NCT03525678|Secondary|Time to Response by Investigator Assessment (Full Analysis Population)|Time to response is defined as the time between the date of randomization and the first documented evidence of response (PR or better), among participants who achieve a response (i.e., confirmed PR or better). Time to response based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of time to response are presented.|Up to 48 weeks|Full Analysis Population. Only those participants with data available at the specified data points were analyzed.|||Months||Inter-Quartile Range|Median
2528171|NCT03525678|Secondary|Duration of Response by Independent Review Committee (Efficacy Population)|DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.|Up to 48 weeks|Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population. Only those participants with data available at the specified data points were analyzed.|||Months||Inter-Quartile Range|Median
2528172|NCT03525678|Secondary|Duration of Response by Independent Review Committee (Full Analysis Population)|DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by IRC is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.|Up to 48 weeks|Full Analysis Population. Only those participants with data available at the specified data points were analyzed.|||Months||Inter-Quartile Range|Median
2528173|NCT03525678|Secondary|Duration of Response by Investigator Assessment (Efficacy Population)|DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented PD per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.|Up to 48 weeks|Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population. Only those participants with data available at the specified data points were analyzed.|||Months||Inter-Quartile Range|Median
2528174|NCT03525678|Secondary|Duration of Response (DoR) by Investigator Assessment (Full Analysis Population)|DoR is defined as the time from first documented evidence of PR or better until the earliest date of documented disease progression (PD) per IMWG response criteria; or death due to PD among participants who achieved an overall response, i.e., confirmed PR or better. DOR based on responses assessed by investigator is presented. Median and inter-quartile range (first quartile and third quartile) of DOR are presented.|Up to 48 weeks|Full Analysis Population. Only those participants with data available at the specified data points were analyzed.|||Months||Inter-Quartile Range|Median
2528175|NCT03525678|Secondary|Clinical Benefit Rate by Independent Review Committee (Efficacy Population)|CBR was determined according to the 2016 IMWG response criteria by IRC. CBR was calculated as the percentage of participants with a confirmed MR or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method.|Up to 48 weeks|Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population.|||Percentage of Participants||95% Confidence Interval|Number
2528176|NCT03525678|Secondary|Clinical Benefit Rate by Independent Review Committee (Full Analysis Population)|CBR was determined according to the 2016 IMWG response criteria by IRC. CBR was calculated as the percentage of participants with a confirmed MR or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method.|Up to 48 weeks|Full Analysis Population|||Percentage of Participants||95% Confidence Interval|Number
2528177|NCT03525678|Secondary|Clinical Benefit Rate by Investigator Assessment (Efficacy Population)|CBR was determined by the investigator according to the 2016 IMWG response criteria. CBR was calculated as the percentage of participants with a confirmed MR or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method.|Up to 48 weeks|Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population.|||Percentage of Participants||95% Confidence Interval|Number
2528178|NCT03525678|Secondary|Clinical Benefit Rate (CBR) by Investigator Assessment (Full Analysis Population)|CBR was determined by the investigator according to the 2016 IMWG response criteria. CBR was calculated as the percentage of participants with a confirmed minimal response (MR) or better (i.e., MR, PR, VGPR, CR and sCR). Confidence intervals were based on the exact method.|Up to 48 weeks|Full Analysis Population|||Percentage of Participants||95% Confidence Interval|Number
2528179|NCT03525678|Secondary|Overall Response Rate by Investigator Assessment (Efficacy Population)|ORR was determined by the investigator according to the 2016 IMWG response criteria. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method.|Up to 48 weeks|Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population.|||Percentage of Participants||95% Confidence Interval|Number
2528180|NCT03525678|Secondary|Overall Response Rate by Investigator Assessment (IA) (Full Analysis Population)|ORR was determined by the investigator according to the 2016 IMWG response criteria. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method.|Up to 48 weeks|Full Analysis Population|||Percentage of Participants||95% Confidence Interval|Number
2528181|NCT03525678|Primary|Overall Response Rate by Independent Review Committee (Efficacy Population)|ORR was determined according to the 2016 IMWG response criteria by IRC. ORR was calculated as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR). Confidence intervals were based on the exact method. Efficacy Population comprised of first 130 intent-to-treat participants whether or not randomized treatment (frozen solution) was administered. Intent-to-treat Population comprised of all randomized participants whether or not randomized treatment was administered.|Up to 48 weeks|Efficacy Population. Data is not presented for 'GSK2857916 3.4 mg/kg (Lyophilized)' arm as it is not included in Efficacy Population.|||Percentage of Participants||95% Confidence Interval|Number
2528182|NCT03525678|Primary|Overall Response Rate (ORR) by Independent Review Committee (IRC) (Full Analysis Population)|ORR was determined according to the 2016 international myeloma working group (IMWG) response criteria by IRC. ORR was calculated as the percentage of participants with a confirmed partial response (PR) or better (that is [i.e.], PR, very good partial response [VGPR], complete response [CR] and stringent complete response [sCR]). Confidence intervals were based on the exact method.|Up to 48 weeks|Full Analysis Population comprised of all randomized participants (any participant who received a treatment randomization number was considered as randomized) whether or not randomized treatment was administered. This population was based on the treatment the participant was randomized to.|||Percentage of Participants||97.5% Confidence Interval|Number
2528183|NCT03525548|Secondary|Observed Pre-Dose Concentration (Ctrough) of VX-445, TEZ, TEZ Metabolite (M1-TEZ), and IVA||Day 1 and Week 4|"Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug in the TC treatment period. Here Number analyzed signifies those participants who were evaluable at specified time points."|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2528184|NCT03525548|Secondary|Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)||From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to Week 8)|Safety set included all participants who received at least 1 dose of study drug in the TC treatment period.|||participants|||Number
2528185|NCT03525548|Secondary|Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicate fewer symptoms and better health-related quality of life.|From Baseline at Week 4|FAS.|||units on a scale||Standard Error|Least Squares Mean
2528186|NCT03525548|Secondary|Absolute Change in Sweat Chloride (SwCl)|Sweat samples were collected using an approved collection device.|From Baseline at Week 4|FAS.|||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
2528187|NCT03525548|Primary|Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|From Baseline at Week 4|Full analysis set (FAS) included all randomized participants who carried the intended CF transmembrane conductance regulator gene (CFTR) allele mutation and received at least 1 dose of study drug in the TC Treatment Period.|||percentage points||Standard Error|Least Squares Mean
2528188|NCT03524157|Secondary|Ocular Pruritus (P)|"Ocular pruritus is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale:~Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.~Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time."|will be evaluated at the end of the treatment at the final visit (day 10)||||cases|eyes||Number
2528189|NCT03524157|Secondary|Foreign Body Sensation (FBS)|"Foreign body sensation is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale:~Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.~Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time."|will be evaluated at the end of the treatment at the final visit (day 10)||||cases|eyes||Number
2528190|NCT03524157|Secondary|Ocular Burning (OB)|ocular burning is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time.|will be evaluated at the end of the treatment at the final visit (day 10)||||cases|eyes||Number
2528191|NCT03524157|Secondary|Chemosis|The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.|will be evaluated at the end of the treatment at the final visit (day 10)||||cases|eyes||Number
2528192|NCT03524157|Secondary|Conjunctival Hyperemia (CH)|Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very mild / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Moderate and severe are considered pathological.|will be evaluated at the end of the treatment at the final visit (day 10)||||cases|eyes||Number
2528193|NCT03524157|Secondary|Breakup Time (BUT)|breakup time lacrimal film is a continuous variable that will be measured in seconds, evaluating the time it takes to break it, is done by direct counting and the normality range and mayor to 10 seconds.|will be evaluated at the end of the treatment at the final visit (day 10)||||seconds|eyes|Standard Deviation|Mean
2528222|NCT03522350|Primary|Number of Day 3 Embryos|Comparing number of embryos that fertilized normally and had development at Day 3 based on embryo grade between oocytes assigned to Standard EmbryoScope versus oocytes assigned to EmbryoScope+|Day 3 post retrieval|Number of day 3 embryos compared in both groups|||embryos|embryos||Count of Units
2528194|NCT03524157|Secondary|Epithelial Defects (ED)|The epithelial defects will be evaluated by means of two stains, green lysine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.|will be evaluated at the end of the treatment at the final visit (day 10)||||eyes|eyes||Number
2528195|NCT03524157|Secondary|Intraocular Pressure (IOP)|the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg|will be evaluated at the end of the treatment at the final visit (day 10)||||mmHg||Standard Deviation|Mean
2528196|NCT03524157|Secondary|Presence of Adverse Events (AEs)|the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent.|during the 13 days of evaluation, including the safety call (day 13).||||adverse events|||Number
2528197|NCT03524157|Primary|Goblet Cell Density (GCD)|the cells will be measured per square millimeter, it is a continuous variable taken by means of cytology per impression, the normal value is higher than 500 cells per square millimeter|will be evaluated at the end of the treatment at the final visit (day 10)||||cells/mm2|eyes|Standard Deviation|Mean
2528198|NCT03523988|Primary|Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment|"Pain scores were measured and recorded by selecting a number [0-10] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax.~The VAS consisted of a 10cm numerical scale from 0, representing no pain, to 10, representing worst possible, unbearable, excruciating pain."|2 days after orthodontic treatment||||scores on a scale||Standard Deviation|Mean
2528199|NCT03523988|Primary|Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment|"Pain scores were measured and recorded by selecting a number [0-10] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax.~The VAS consisted of a 10cm numerical scale from 0, representing no pain, to 10, representing worst possible, unbearable, excruciating pain."|1 day after orthodontic treatment||||scores on a scale||Standard Deviation|Mean
2528200|NCT03523988|Primary|Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment|"Pain scores were measured and recorded by selecting a number [0-10] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax.~The VAS consisted of a 10cm numerical scale from 0, representing no pain, to 10, representing worst possible, unbearable, excruciating pain."|6 hours after orthodontic treatment||||scores on a scale||Standard Deviation|Mean
2528201|NCT03522675|Other Pre-specified|Wheal Formation|Wheal formation is defined as a raised, pale, itchy formation (allergic reaction) on the skin's surface. A positive (+) allergic response would be indicated by the NeoMatriXTM Wound Matrix producing a wheal >3 mm of the positive control (histamine).|2 days||||mm||Full Range|Mean
2528202|NCT03522675|Other Pre-specified|Wheal Formation|Wheal formation is defined as a raised, pale, itchy formation (allergic reaction) on the skin's surface. A positive (+) allergic response would be indicated by the NeoMatriXTM Wound Matrix producing a wheal >3 mm of the positive control (histamine).|6 hrs||||mm||Full Range|Mean
2528203|NCT03522675|Primary|Wheal Formation|Wheal formation is defined as a raised, pale, itchy formation (allergic reaction) on the skin's surface. A positive (+) allergic response would be indicated by the NeoMatriXTM Wound Matrix producing a wheal >3 mm of the positive control (histamine).|15 minutes||||mm||Full Range|Mean
2528204|NCT03522506|Primary|Latency to Sleep Onset on MWT at 1 Hour Post-end of Infusion|The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.|Day 1: 1 hour post-end of infusion|The PD analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 evaluable postdose PD endpoint derived from the MWT, PSG, KSS, or CCBT. The PD analysis set where data at specified time points was available.|||minute||Standard Error|Least Squares Mean
2528205|NCT03522506|Primary|Latency to Sleep Onset on MWT at 8 Hours Post-infusion Start|The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.|Day 1: 8 hours post-infusion start|The PD analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 evaluable postdose PD endpoint derived from the MWT, PSG, KSS, or CCBT. The PD analysis set where data at specified time points was available.|||minute||Standard Error|Least Squares Mean
2528206|NCT03522506|Primary|Latency to Sleep Onset on MWT at 6 Hours Post-infusion Start|The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.|Day 1: 6 hours post-infusion start|The PD analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 evaluable postdose PD endpoint derived from the MWT, PSG, KSS, or CCBT. The PD analysis set where data at specified time points was available.|||minute||Standard Error|Least Squares Mean
2528207|NCT03522506|Primary|Latency to Sleep Onset on MWT at 4 Hours Post-infusion Start|The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.|Day 1: 4 hours post-infusion start|The PD analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 evaluable postdose PD endpoint derived from the MWT, PSG, KSS, or CCBT. The PD analysis set where data at specified time points was available.|||minute||Standard Error|Least Squares Mean
2528208|NCT03522506|Secondary|Sleepiness on KSS|The KSS scale measures the subjective level of sleepiness at a particular time during the day. On this scale participants indicate which level best reflects the psycho-physical state experienced in the last 10 minutes. The KSS is a 9-item Likert-type rating scale for assessing subjective sleepiness, where 1=very alert, 3=alert, 5=neither alert nor sleepy, 7=sleepy (but not fighting sleep), 9=very sleepy (fighting sleep). Lower score indicates more alertness.|Day 1: 14, 10, 6, 2 hours pre-infusion; 2.75, 4.75, 6.75. 8.75 hours post-infusion start; 1.75 hours post-infusion end|The PD analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 evaluable postdose PD endpoint derived from the MWT, PSG, KSS, or CCBT. The PD analysis set where data at specified time points was available.|||unit on a scale||Standard Error|Least Squares Mean
2528209|NCT03522506|Secondary|Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-925||Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose|The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration.|||liter||Standard Deviation|Mean
2528210|NCT03522506|Secondary|Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-925||Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose|The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration.|||liter||Standard Deviation|Mean
2528211|NCT03522506|Secondary|CL: Total Clearance After Intravenous Administration for TAK-925||Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose|The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration.|||liter per hour (L/h)||Standard Deviation|Mean
2528212|NCT03522506|Secondary|T1/2z: Terminal Disposition Phase Half-life for TAK-925 and Its Metabolites M-I and M-II||Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose|The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration. The PK analysis set where data at specified time points was available.|||hour||Standard Deviation|Mean
2528213|NCT03522506|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-925 and Its Metabolites M-I and M-II||Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose|The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration.|||hour||Full Range|Median
2528214|NCT03522506|Secondary|Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-925 and Its Metabolites M-I and M-II||Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose|The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration.|||ng/mL||Standard Deviation|Mean
2528215|NCT03522506|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-925 and Its Metabolites M-I and M-II||Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose|The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2528216|NCT03522506|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925 and Its Metabolites M-I and M-II||Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose|The PK analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration. The PK analysis set where data at specified time points was available.|||h*ng/mL||Standard Deviation|Mean
2528217|NCT03522506|Secondary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-925 and Its Metabolites M-I and M-II||Day 1 pre-dose and at multiple time points (up to 9 hours) post-dose|The pharmacokinetic (PK) analysis set consisted of all participants who received at least 1 dose of study drug and have at least 1 measurable plasma concentration.|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
2528218|NCT03522506|Primary|Latency to Sleep Onset on Maintenance of Wakefulness Test (MWT) at 2 Hours Post-infusion Start|The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.|Day 1: 2 hours post-infusion start|Pharmacodynamics (PD) analysis set: all participants who received at least 1 dose of study drug and have at least 1 evaluable postdose PD endpoint derived from MWT, polysomnography (PSG), Karolinska Sleepiness Scale (KSS), or Cambridge Cognition Computerized Battery of Tests (CCBT). PD analysis set where data at specified time points was available.|||minute||Standard Error|Least Squares Mean
2528219|NCT03522350|Secondary|Pregnancy Rate|Positive Bhcg|2 weeks post retrieval||||Participants|||Count of Participants
2528220|NCT03522350|Secondary|Implantation Rate|Presence of a gestational sac|5-6 weeks post retrieval||||Participants|||Count of Participants
2528267|NCT03519932|Primary|Comfort|Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)|1-month||||units on a scale||Standard Deviation|Mean
2528223|NCT03521791|Other Pre-specified|Number of Eyes With Ocular Burning (OB)|"primary tolerability variable~Ocular burning is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale:~Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time."|will be evaluated at the end of the treatment at the final visit (day 21)|the statistical analysis was carried out by protocol (PP)|||eyes|eyes||Count of Units
2528224|NCT03521791|Secondary|Epithelial Defects (ED) Fluorescein Stain|The epithelial defects will be evaluated by means of two stains, green lysine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.|will be evaluated at the end of the treatment at the final visit (day 21)|the statistical analysis was carried out by protocol (PP)|||eyes|eyes||Count of Units
2528225|NCT03521791|Secondary|Number of Eyes With Foreign Body Sensation (FBS)|Foreign body sensation will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.|will be evaluated at the end of the treatment at the final visit (day 21)|the statistical analysis was carried out by protocol (PP)|||eyes|eyes||Count of Units
2528226|NCT03521791|Secondary|Number of Eyes With Chemosis|In a normal eye there is no presence of chemosis (it is a sign of irritation of the eye, in which the outer covering of the eye can look like a large blister) its presence indicates a pathological state and it will be evaluated if the subjects present it. The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.|will be evaluated at the end of the treatment at the final visit (day 21)|the statistical analysis was carried out by protocol (PP)|||eyes|eyes||Count of Units
2528227|NCT03521791|Secondary|Visual Capacity|The visual capacity variable will be reported using as a unit of measure a fraction, this is taken from a visual test with the Snellen primer, it is a Nominal type variable. where the optimal vision is 20/20.|will be evaluated at the end of the treatment at the final visit (day 21)||||LogMAR|eyes|Standard Deviation|Mean
2528228|NCT03521791|Secondary|Presence of Adverse Events (EAS)|primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent. Adverse events that are reported until the safety call to the 36th day of the study will be considered for this variable|will be evaluated at the end of the treatment at the final visit (day 36)|The analysis of adverse events was done by intention to treat (ITT)|||Participants|||Count of Participants
2528229|NCT03521791|Secondary|Intraocular Pressure (IOP)|the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg|will be evaluated at the end of the treatment at the final visit (day 21)|the statistical analysis was carried out by protocol (PP)|||mmHg|eyes|Standard Deviation|Mean
2528230|NCT03521791|Secondary|Epithelial Defects (ED) Green Lissamine|The epithelial defects will be evaluated by means of two stains, green lysine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.|will be evaluated at the end of the treatment at the final visit (day 21)||||eyes|eyes||Count of Units
2528231|NCT03521791|Primary|Breakup Time (BUT)|breakup time lacrimal film is a continuous variable that will be measured in seconds, evaluating the time it takes to break it, is done by direct counting and the normality range and mayor to 10 seconds.|will be evaluated at the end of the treatment at the final visit (day 21)|Statistical analysis was performed by protocol (PP)|||seconds|eyes|Standard Deviation|Mean
2528232|NCT03521791|Primary|Conjunctival Hyperemia (CH)|Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.|will be evaluated at the end of the treatment at the final visit (day 21)|statistical analysis by protocol (PP)|||eyes|eyes||Number
2528233|NCT03521089|Primary|Change in Oral Reading Recognition Test Score|Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test. The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance. The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.|Baseline, 1 month post intervention||||score on a scale||Standard Error|Least Squares Mean
2528234|NCT03521089|Primary|Change in Picture Sequence Memory Test v2.1 Score|Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test. The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance. The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.|Baseline, 1 month post intervention||||score on a scale||Standard Error|Least Squares Mean
2528235|NCT03521089|Primary|Change in Pattern Comparison Processing Speed Test Scores|Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test. The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance. The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.|Baseline, 1 month post intervention||||score on a scale||Standard Error|Least Squares Mean
2528268|NCT03519932|Primary|Comfort|Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)|2 weeks|One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use.|||units on a scale||Standard Deviation|Mean
2528236|NCT03521089|Primary|Change in Dimensional Change Card Sort Test|Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test. The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance. The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.|Baseline, 1 month post intervention||||score on a scale||Standard Error|Least Squares Mean
2528237|NCT03521089|Primary|Change in List Sorting Working Memory Test Scores|Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test. The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance. The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.|Baseline, 1 month post intervention||||score on a scale||Standard Error|Least Squares Mean
2528238|NCT03521089|Primary|Change in Picture Vocabulary Test Scores|Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test. The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance. The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.|Baseline, 1 month post intervention||||score on a scale||Standard Error|Least Squares Mean
2528239|NCT03521089|Primary|Change in Flanker Inhibitory Control and Attention Test Scores|Post-intervention score comparison between the intervention and control group measured by the NIH Toolbox Cognition Battery Test. The NIH Toolbox Cognition Battery Test is a comprehensive set of neuro behavioral measurements used to assess cognitive, sensory and motor functions where a higher composite score equals better cognitive performance. The NIH Toolbox Cognitive Scores used the Fully Adjusted Scale score (also referred to as the fully corrected T-score) with a mean of 50 and standard deviation of 10.|Baseline, 1-month post intervention||||score on a scale||Standard Error|Least Squares Mean
2528240|NCT03520959|Secondary|Number of Participants Who Discontinued Study Treatment Due to an AE|The number of all participants who discontinued study treatment due to an AE is presented.|Up to approximately 2 months|All participants taking any amount of study drug.|||Participants|||Number
2528241|NCT03520959|Secondary|Quality of Life (QoL): EuroQol 5-Dimension 5 Level (EQ-5D-5L) and EuroQol 5-Dimension Youth (EQ-5D-Y) Questionnaires|QoL evaluated using the EQ-5D-5L for participants ≥18 years of age or using the EQ-5D-Y for participants 12 to <18 years of age. EQ-5D-5L descriptive system is comprised of 5 dimensions-mobility, self-care, usual activities, pain/discomfort & anxiety/depression. Each dimension has 5 levels: not at all (level 1), mild (level 2), moderate (level 3), severe (level 4), extreme/leading to incapacity (level 5), with highest level corresponding to worst outcome. Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value using the EQ-5D-5L crosswalk index value calculator as recommended by EuroQol group. In the EQ-VAS, participants recorded their health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).|From Day 1 up to 12 months|No data were collected or analyzed for this outcome measure due to early termination of the study.||||||
2528242|NCT03520959|Secondary|Number of Participants Who Experienced a Treatment-Emergent Adverse Event (TEAE)|Safety will be assessed primarily based on reported adverse events (AEs), Medical Events of Interest (MEOIs), laboratory values, and concomitant medications reported from initiation of treatment with CMB305 or placebo.|From randomization to investigator-determined date of disease progression or death, assessed up to approximately 2 months.|All participants taking any amount of study drug.|||Participants|||Number
2528243|NCT03520959|Secondary|Overall Response Rate (ORR)|ORR defined by RECIST v1.1 will be summarized by the number and percent of subjects who achieve a complete response (CR) or partial response (PR) based on the investigator's assessment. ORR will be compared between treatment arms using a logistic regression.|From randomization to investigator-determined date of disease progression, assessed up to 24 months.|No data were collected or analyzed for this outcome measure due to early termination of the study.||||||
2528244|NCT03520959|Secondary|Distant Metastasis Free Survival (DMFS)|DMFS is defined as the time from randomization to evidence of a new distant metastasis not documented at time of randomization: [DMFS = a new distant metastasis documented date - randomization date + 1]. Participants who do not have any new distant metastasis will be censored at their last tumor assessment.|From randomization to investigator-determined date of disease progression or death, assessed up to 24 months.|No data were collected or analyzed for this outcome measure due to early termination of the study.||||||
2528245|NCT03520959|Secondary|Time to Next Treatment (TTNT)|TTNT is defined as the time from randomization to the start of post-study treatment subsequent intervention: [TTNT = start date of subsequent intervention - randomization date + 1]. Subsequent intervention includes anticancer therapy, cancer-related surgery and local regional therapy. Participants who do not start any post-study treatment intervention will be censored at their last known date of being alive.|From last dose of CMB305 to initiation of new therapy, assessed up to 24 months.|No data were collected or analyzed for this outcome measure due to early termination of the study.||||||
2528246|NCT03520959|Primary|Overall Survival (OS)|OS is defined as the time from randomization to the date of death.|From randomization to date of death, assessed up to 66 months.|No data were collected or analyzed for this outcome measure due to early termination of the study.||||||
2528247|NCT03520959|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization to the investigator-determined date of disease progression or death, whichever comes first, using Response Evaluation Criteria in Solid Tumors (RECIST v1.1).|From randomization to investigator-determined date of disease progression or death, assessed up to 24 months.|No data were collected or analyzed for this outcome measure due to early termination of the study.||||||
2528269|NCT03519932|Primary|Comfort at Insertion|Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)|Dispense||||units on a scale||Standard Deviation|Mean
2546967|NCT02915029|Secondary|Triglycerides|Change in serum triglycerides on study|12 months minus baseline values||||mg/dl||Inter-Quartile Range|Median
2528248|NCT03520348|Secondary|Ocular Pruritus (P)|"Ocular pruritus is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale:~Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.~Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time."|will be evaluated at the end of the treatment at the final visit (day 11)|the statistical analysis of the sample was carried out by protocol|||percentage of participants|eyes||Number
2528249|NCT03520348|Secondary|Foreign Body Sensation (FBS)|"Foreign body sensation is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale:~Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.~Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time."|will be evaluated at the end of the treatment at the final visit (day 11)|the statistical analysis of the sample was carried out by protocol|||percentage of participants|eyes||Number
2528250|NCT03520348|Secondary|Conjunctival Hyperemia (CH)|Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.|will be evaluated at the end of the treatment at the final visit (day 11)|the statistical analysis of the sample was carried out by protocol|||percentage of participants|eyes||Number
2528251|NCT03520348|Secondary|Epithelial Defects (ED)|The epithelial defects will be evaluated by means of two stains, green lissamine, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.|will be evaluated at the end of the treatment at the final visit (day 11)|the statistical analysis of the sample was carried out by protocol|||cases|eyes||Number
2528252|NCT03520348|Secondary|Ocular Burning (OB)|ocular burning is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale: Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent.Frequency: At all times, almost at all times, 50% of the time, almost in no time, at any time. where the normality of the frequency is in no time.|will be evaluated at the end of the treatment at the final visit (day 11)|the statistical analysis of the sample was carried out by protocol|||percentage of participants|eyes||Number
2528253|NCT03520348|Secondary|Chemosis|The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.|will be evaluated at the end of the treatment at the final visit (day 11)|the statistical analysis of the sample was carried out by protocol|||cases|eyes||Number
2528254|NCT03520348|Secondary|Breakup Time (BUT)|breakup time lacrimal film is a continuous variable that will be measured in seconds, evaluating the time it takes to break it, is done by direct counting and the normality range greater than 10 seconds.|will be evaluated at the end of the treatment at the final visit (day 11)|the statistical analysis of the sample was carried out by protocol|||seconds|eyes|Standard Deviation|Mean
2528255|NCT03520348|Secondary|Intraocular Pressure (IOP)|the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg|will be evaluated at the end of the treatment at the final visit (day 11)|the statistical analysis of the sample was carried out by protocol|||mmHg|eyes|Standard Deviation|Mean
2528256|NCT03520348|Secondary|Presence of Adverse Events (EAS)|the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent.|during the 11 days of evaluation, including the safety call (day 13).||||cases|||Number
2528257|NCT03520348|Primary|Goblet Cell Density (GCD)|the cells will be measured per square millimeter, it is a continuous variable taken by means of cytology per impression, the normal value is higher than 500 cells per square millimeter|will be evaluated at the end of the treatment at the final visit (day 11)||||cells/mm^2|eyes|Standard Deviation|Mean
2528258|NCT03519932|Secondary|Ease of Removal|Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)|1 month||||units on a scale||Standard Deviation|Mean
2528259|NCT03519932|Secondary|Ease of Removal|Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)|2-weeks|One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use.|||units on a scale||Standard Deviation|Mean
2528260|NCT03519932|Secondary|Ease of Insertion|Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)|1-month||||units on a scale||Standard Deviation|Mean
2528261|NCT03519932|Secondary|Ease of Insertion|Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)|2-weeks|One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use.|||units on a scale||Standard Deviation|Mean
2528262|NCT03519932|Secondary|Ease of Insertion|Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)|Dispense||||units on a scale||Standard Deviation|Mean
2528263|NCT03519932|Primary|Dryness|Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)|1-month||||units on a scale||Standard Deviation|Mean
2528264|NCT03519932|Primary|Dryness|Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)|2 weeks|One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use.|||units on a scale||Standard Deviation|Mean
2528265|NCT03519932|Primary|Lens Preference Based on Overall Dryness|Lens preference with respect to dryness (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)|1 month||||percentage of participants|||Number
2528266|NCT03519932|Primary|Lens Preference Based on Overall Comfort|Lens preference with respect to comfort (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)|1 month|Percentages may be rounded and therefore may not add up to equal to 100%|||percentage of participants|||Number
2528274|NCT03519919|Secondary|Overall Satisfaction With Speed of Changing Focus|Subjective rating for speed and ability to change focus between distances for somofilcon A multifocal lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)|3 weeks||||percentage of participants|||Number
2528275|NCT03519919|Secondary|Overall Satisfaction With Speed of Changing Focus|Subjective rating for speed and ability to change focus between distances for habitual lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)|Baseline||||percentage of participants|||Number
2528276|NCT03519919|Secondary|Ease of Removal|Subjective rating for somofilcon A multifocal lens on how easy lens was removed from eye (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)|3 weeks||||percentage of participants|||Number
2528277|NCT03519919|Secondary|Ease of Removal|Subjective rating for habitual lens on how easy lens was removed from eye (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)|Baseline||||percentage of participants|||Number
2528278|NCT03519919|Secondary|Ease of Insertion|Subjective rating how easy lens was inserted on eye for somofilcon A multifocal lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)|3 weeks||||percentage of participants|||Number
2528279|NCT03519919|Secondary|Ease of Insertion|Subjective rating how easy lens was inserted on eye for habitual lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)|Baseline||||percentage of participants|||Number
2528280|NCT03519919|Secondary|Subjective Vision Satisfaction - Near Vision|Subjective satisfaction of near vision while reading on cell phone and hand-held materials for somofilcon A multifocal lens (1 = fell short of expectation, 2 = met expectation, 3 = exceed expectation)|3 weeks||||percentage of participants|||Number
2528281|NCT03519919|Secondary|Subjective Vision Satisfaction - Near Vision|Subjective satisfaction of near vision while reading on cell phone and hand-held materials for habitual lens (1 = fell short of expectation, 2 = met expectation, 3 = exceed expectation)|Baseline||||percentage of participants|||Number
2528282|NCT03519919|Secondary|Subjective Vision Satisfaction - Short Intermediate Tasks|Subjective satisfaction of short/intermediate vision while using laptop/tablet for somofilcon A multifocal lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)|3 weeks||||percentage of participants|||Number
2528283|NCT03519919|Secondary|Subjective Vision Satisfaction - Short Intermediate Tasks|Subjective satisfaction of short/intermediate vision while using laptop/tablet for habitual lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)|Baseline||||percentage of participants|||Number
2528284|NCT03519919|Secondary|Subjective Vision Satisfaction - Long Intermediate Vision|Subjective satisfaction of long intermediate vision while using desktop computer for somofilcon A multifocal lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)|3 weeks||||percentage of participants|||Number
2528285|NCT03519919|Secondary|Subjective Vision Satisfaction - Long Intermediate Vision|Subjective satisfaction of long intermediate vision while using desktop computer for habitual lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)|Baseline||||percentage of participants|||Number
2528286|NCT03519919|Secondary|Subjective Vision Satisfaction - Driving at Night|Subjective satisfaction of distance vision while driving at night responses for somofilcon A multifocal lens (1= fell short of expectation, 2 = met expectation, 3= exceed expectation)|3 weeks||||percentage of participants|||Number
2528287|NCT03519919|Secondary|Subjective Vision Satisfaction - Driving at Night|Subjective satisfaction of distance vision while driving at night responses for habitual lens (1= fell short of expectation, 2 = met expectation, 3= exceed expectation)|Baseline||||percentage of participants|||Number
2528288|NCT03519919|Secondary|Bulbar Hyperemia|Grading hyperemia of bulbar conjunctiva on a scale ranged from 0-4 and in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.|3 weeks||||units on a scale||Standard Deviation|Mean
2528289|NCT03519919|Secondary|Bulbar Hyperemia|Grading hyperemia of bulbar conjunctiva on a scale ranged from 0-4 and in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.|Baseline||||units on a scale||Standard Deviation|Mean
2528290|NCT03519919|Secondary|Conjunctival Staining|Conjunctival staining will be assessed using CORE integer scale (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentationfor following regions: Temporal, Superior, Nasal, Inferior.|3 weeks||||units on a scale||Standard Deviation|Mean
2528291|NCT03519919|Secondary|Conjunctival Staining|Conjunctival staining will be assessed using CORE integer scale (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentation for following regions: Temporal, Superior, Nasal, Inferior.|Baseline||||units on a scale||Standard Deviation|Mean
2528292|NCT03519919|Secondary|Corneal Staining|Corneal staining will be assessed for extent (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentation for following regions: Temporal, Superior, Nasal, Inferior and Central.|3 weeks||||units on a scale||Standard Deviation|Median
2528293|NCT03519919|Secondary|Corneal Staining|Corneal staining will be assessed for extent (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentation for following regions: Temporal, Superior, Nasal, Inferior and Central.|Baseline||||units on a scale||Standard Deviation|Median
2528294|NCT03519919|Secondary|Post-blink Lens Movement|Movement of lens on eye after blink was graded on a 5-point scale (0-4, 1 steps) as follows: 0 - insufficient, 1 - minimal but acceptable, 2 - optimal, 3 - moderate but acceptable , and 4 - excessive unacceptable.|3 weeks||||percentage of participants|||Number
2528295|NCT03519919|Secondary|Post-blink Lens Movement|Movement of lens on eye after blink was graded on a 5-point Likert scale (0-4, 1 steps) as follows: 0 - insufficient, 1 - minimal but acceptable, 2 - optimal, 3 - moderate but acceptable, and 4 - excessive unacceptable movement.|Baseline||||percentage of particpants|||Number
2528296|NCT03519919|Secondary|Visual Acuity|Distance visual acuity (logMAR)|3 weeks||||logMar||Standard Deviation|Mean
2528297|NCT03519919|Secondary|Visual Acuity|Distance visual acuity (logMAR)|Baseline||||logMar||Standard Deviation|Mean
2528298|NCT03519919|Secondary|Number of Participants With Lens Centration|Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (>=0.5mm))|3 weeks||||Participants|||Count of Participants
2528300|NCT03519919|Primary|Vision Clarity During the Day - Distance Vision|"Subjective expectation - Vision clarity during the day - distance vision was measured from three subjective expectation responses completed at the office. The responses were assigned numbers as below:~Fell short of expectations = 1 Met my expectations = 2 Exceeded my expectations = 3"|3 weeks||||percentage of participants|||Number
2528301|NCT03519919|Primary|Vision Clarity During the Day - Distance Vision|"Subjective expectation -Vision clarity during the day - distance vision was measured from three subjective expectation responses completed at the office. The responses were assigned numbers as below:~Fell short of expectations = 1 Met my expectations = 2 Exceeded my expectations = 3"|Baseline||||percentage of participants|||Number
2528302|NCT03519867|Secondary|Percentage of Participants Experiencing ≥1 Adverse Events (AEs)|The percentage of participants experiencing ≥1 AEs was determined. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment.|Up to 7 days following MK-8616 administration|All participants who received a dose of study treatment are included.|||Percentage of Participants|||Number
2528303|NCT03519867|Primary|Time From Start of Administration of MK-8616 to Recovery T4/T1 Ratio to 0.9|The mean time from the start of MK-8616 administration to recovery T4/T1 ratio of 0.9 was determined. Less time indicates faster recovery from NMB. The ratio of T4 (fourth twitch; amplitude of fourth response to train of four [TOF] stimulation is expressed as percent of control T4) over T1 (first twitch; amplitude of first response to TOF stimulation is expressed as percent of control T1) ranges from 0 (complete loss of T4 twitch response) to 1.0 (complete recovery of T4 twitch response). For TOF stimulation, 4 consecutive square wave supra-maximal stimuli of 0.2 msec duration were delivered at 2 Hz every 15 seconds. Neuromuscular monitoring was performed with the TOF-Watch® SX.|Up to 90 minutes|All randomized participants who received ≥1 dose of study drug, had ≥1 post baseline efficacy measurement, and did not have any important protocol violations are included.|||Minutes||Standard Deviation|Mean
2528304|NCT03519854|Secondary|Number of Participants Experiencing an Adverse Event|The number of participants experiencing an adverse event (AE) was assessed. An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product.|Up to 7 days following administration of study treatment|"Includes all randomized participants receiving study treatment. One participant randomized to receive 2 mg/kg Sugammadex, given 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the Arm A. Placebo; given 3 minutes after Esmeron® arm."|||Participants|||Count of Participants
2528305|NCT03519854|Secondary|Mean Corrected QT Interval (QTc) at 30 Minutes Following Administration of Study Treatment|Mean QTc interval at 30 minutes following administration of study treatment was assessed. The QTc interval is corrected for participant heart rate at 30 minutes following study treatment administration using Fridericia's correction, where QTc = QT interval/(RR interval)^(1/3). RR interval = 60/heart rate.|30 minutes following administration of study treatment|"All randomized participants receiving study treatment, having data available at 30 minutes following administration of study treatment. One participant randomized to receive 2 mg/kg Sugammadex at 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the Arm A. Placebo; given 3 minutes after Esmeron® arm."|||msec||Standard Deviation|Mean
2528306|NCT03519854|Secondary|Mean Corrected QT Interval (QTc) at 2 Minutes Following Administration of Study Treatment|Mean QTc interval at 2 minutes following administration of study treatment was assessed. The QTc interval is corrected for participant heart rate at 2 minutes following study treatment administration using Fridericia's correction, where QTc = QT interval/(RR interval)^(1/3). RR interval = 60/heart rate.|2 minutes following administration of study treatment|"All randomized participants receiving study treatment, having data available at 2 minutes following administration of study treatment. One participant randomized to receive 2 mg/kg Sugammadex at 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the Arm A. Placebo; given 3 minutes after Esmeron® arm."|||msec||Standard Deviation|Mean
2528307|NCT03519854|Secondary|Mean Corrected QT Interval (QTc) at Baseline|Mean QTc interval at baseline was assessed. Baseline QTc interval was defined as the QTc interval measured under stable anesthesia prior to administration of study treatment. The baseline QTc interval is corrected for participant heart rate at baseline prior to study treatment administration using Fridericia's correction, where QTc = QT interval/(RR interval)^(1/3). RR interval = 60/heart rate.|Up to 45 minutes prior to study treatment administration|"All randomized participants receiving study treatment, having data available at baseline prior to administration of study treatment. One participant randomized to receive 2 mg/kg Sugammadex, given 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the Arm A. Placebo; given 3 minutes after Esmeron® arm."|||milliseconds (msec)||Standard Deviation|Mean
2528308|NCT03519854|Secondary|Mean Heart Rate at 30 Minutes Following Administration of Study Treatment|Mean heart rate at 30 minutes following administration of study treatment was assessed.|30 minutes following administration of study treatment|"All randomized participants receiving study treatment, having data available at 30 minutes following administration of study treatment. One participant randomized to receive 2 mg/kg Sugammadex at 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the Arm A. Placebo; given 3 minutes after Esmeron® arm."|||bpm||Standard Deviation|Mean
2528309|NCT03519854|Secondary|Mean Heart Rate at 2 Minutes Following Administration of Study Treatment|Mean heart rate at 2 minutes following administration of study treatment was assessed.|2 minutes following administration of study treatment|"All randomized participants receiving study treatment, having data available at 2 minutes following administration of study treatment. One participant randomized to receive 2 mg/kg Sugammadex at 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the Arm A. Placebo; given 3 minutes after Esmeron® arm."|||bpm||Standard Deviation|Mean
2528324|NCT03519243|Secondary|Cmax|Maximum serum concentration of the drug product) after the first injection of the test/reference drug|3, 6, 12, 24, 48, 72, 96, 168, 336, 504, 672 h h after injection 1, weeks 5, 9, 13, 17, 21||||mmol/L||Inter-Quartile Range|Median
2528955|NCT03471832|Secondary|Stinging/Burning|Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))|3 hours||||units on a scale|Eyes|Standard Deviation|Mean
2528310|NCT03519854|Secondary|Mean Heart Rate at Baseline|Mean heart rate at baseline was assessed. Baseline heart rate was defined as the heart rate measured under stable anesthesia prior to administration of study treatment.|Up to 45 minutes prior to study treatment administration|"All randomized participants receiving study treatment, having data available at baseline prior to administration of study treatment. One participant randomized to receive 2 mg/kg Sugammadex, given 3 minutes after Esmeron® (Arm C), incorrectly received placebo. This participant is counted in the Arm A. Placebo; given 3 minutes after Esmeron® arm."|||beats per minute (bpm)||Standard Deviation|Mean
2528311|NCT03519854|Primary|Mean Time From Start of Study Treatment Administration to Recovery of the T4/T1 Ratio to 0.9|"Mean time from start of study treatment administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units minutes:seconds (mm:ss), was reformatted to be presented in the single unit of minutes (min)."|Up to 70 minutes following administration of study treatment|Per protocol, includes all randomized participants receiving study treatment without major protocol violations, having data available for this outcome measure.|||minutes||Standard Deviation|Mean
2528312|NCT03519516|Secondary|Visual Capacity|"The visual capacity variable will be reported using as a unit of measure a fraction, this is taken from a visual test with the Snellen primer, it is a Nominal type variable. where the optimal vision is 20/20 and higher scores indicate worse visual acuity.~Snellen Scale: 20/200, 20/100, 20/70, 20/50, 20/40, 20/30, 20/25, 20/20, 20/15, 20/12, 20/10~only the denominator of the fraction of each case is reported and averaged per group."|will be evaluated at the end of the treatment at the final visit (day 7)||||units on a scale (snellen)|eyes|Standard Deviation|Mean
2528313|NCT03519516|Secondary|Number of Eyes of Chemosis|The chemosis will be evaluated, as a nominal variable, by direct observation and it will be staged as present and absent, where the normality is that said variable is absent.|will be evaluated at the end of the treatment at the final visit (day 7)|the statistical analysis of the sample was performed by protocol|||eyes|eyes||Number
2528314|NCT03519516|Secondary|Number of Eyes With Ocular Pruritus (P) by Grade|"Ocular pruritus is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale:~Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent."|will be evaluated at the end of the treatment at the final visit (day 7)|The study population was analyzed by protocol grade 1|||number of eyes with Ocular pruritus|eyes||Number
2528315|NCT03519516|Secondary|Number of Eyes With Foreign Body Sensation (FBS) by Grade|"Foreign body sensation is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale:~Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent."|will be evaluated at the end of the treatment at the final visit (day 7)|The study population was analyzed by protocol|||eyes|eyes||Number
2528316|NCT03519516|Secondary|Percentage of Eyes With Conjunctival Hyperemia (CH) by Grade|Conjunctival hyperemia will be evaluated as an ordinal variable, by direct observation and staged using the Efron scale as Normal / Very Light / Mild / Moderate / Severe. Based on this scale, the normal and mild stages are considered without pathologies or normal. Mild, moderate and severe are considered pathological.|will be evaluated at the end of the treatment at the final visit (day 7)|The study population was analyzed by protocol|||percentage of eyes|eyes||Number
2528317|NCT03519516|Secondary|Number of Eyes With Epithelial Defects (ED) by Grade|The epithelial defects will be evaluated by means of two stains, green lysine and fluorescein, it is a discrete variable that will be realized by direct observation, it will be staged according to the degrees of the oxford scale that go from 0 to 5 (0-V) according to its severity, where 0 is the normal lower limit and 5 the upper limit of defects.|will be evaluated at the end of the treatment at the final visit (day 7)|The study population was analyzed by protocol|||eyes|eyes||Number
2528318|NCT03519516|Secondary|Breakup Time (BUT)|breakup time lacrimal film is a continuous variable that will be measured in seconds, evaluating the time it takes to break it, is done by direct counting and the normality range and mayor to 10 seconds.|will be evaluated at the end of the treatment at the final visit (day 7)|The study population was analyzed by protocol|||seconds|eyes|Standard Deviation|Mean
2528319|NCT03519516|Secondary|Intraocular Pressure (IOP)|the intraocular pressure will be evaluated by means of the Goldman applanation tonometry whose unit of measurement is millimeters of mercury (mmHg), it is a continuous variable and its normality range is between 11 - 21 mmHg|will be evaluated at the end of the treatment at the final visit (day 7)|The study population was analyzed by protocol|||mmHg|eyes|Standard Deviation|Mean
2528320|NCT03519516|Primary|Ocular Burning (OB)|"primary tolerability variable~Ocular burning is a nominal variable that will be evaluated by direct questioning to the research subject, then it will be staged according to the following scale:~Severity: Absent, very mild, mild, moderate and severe, where the normality of severity is absent."|will be evaluated at the end of the treatment at the final visit (day 7)|the analysis of the study population was by protocol|||percentage of participants|eyes||Number
2528321|NCT03519516|Primary|Number of Adverse Events (EAS)|primary security variable the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent.|during the 12 days of evaluation, including the safety call (day 12).|the analysis of the population was by protocol|||adverse events|||Number
2528322|NCT03519243|Secondary|AC-Emax|Maximum absolute reticulocyte count after the first injection of BCD-131/Mircera®|day 28||||(cells*10^9)/L||Standard Deviation|Mean
2528323|NCT03519243|Secondary|AUEC(0-672 Hour)|Area under the effect curve from the drug injection to 672 h [28 days]) based on the change in the absolute reticulocyte count after the first injection of the test/reference drug|3, 6, 12, 24, 48, 72, 96, 168, 336, 504, 672 h h after injection 1||||(cells*10^9)*h||Standard Deviation|Mean
2528956|NCT03471832|Secondary|Stinging/Burning|Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))|5 minutes||||units on a scale|Eyes|Standard Deviation|Mean
2528327|NCT03519243|Secondary|The Proportion of BAb- and NAb-positive Patients|"Blood sampling for immunogenicity assessment (BAbs and NAbs) will be performed in all the patients included in the study before the first injection and then at Week 9 and Week 23.~The immunogenicity endpoints will be analyzed after the completion of all periods of the study."|Week 9, 23||||Participants|||Count of Participants
2528328|NCT03519243|Secondary|The Proportion of Patients Who Developed AEs/SAEs That, in the Investigator's Opinion, Are Related to BCD-131|"The proportion of patients, in each group, who developed СТСАЕ v. 4.03 Grade 3-4 AEs that, in the Investigator's opinion, are related to BCD-131~- the proportion of patients, in each group, who discontinued the study due to AEs/SAEs"|Week 23||||Participants|||Count of Participants
2528329|NCT03519243|Primary|Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period|The baseline hemoglobin will be calculated as the arithmetic mean of hemoglobin values obtained at screening and at Visit 1. The final hemoglobin value during the evaluation period will be calculated as the arithmetic mean of hemoglobin values obtained at Week 21 and Week 23.|Baseline - measurements on Screening (weeks -4 - 0) and on day 1; Evaluation period - weekly measures on weeks 21 to 23||||g/L||Inter-Quartile Range|Median
2528330|NCT03519204|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An Adverse event (AE) is any untoward medical occurrence in a patient or a participant using an investigational drug, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A TEAE is an AE that occurred after receiving the first dose of study device or study injection or an AE present prior to first dose but increased in severity during the Treatment Period.|Baseline to Month 12 Post Treatment|Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated.|||Participants|||Count of Participants
2528331|NCT03519204|Secondary|Number of Participants With Injection Site Responses (ISRs)|ISRs were recorded by the participant in a safety diary for 30 days after each treatment and were summarized by treatment (initial and touch-up). ISRs were defined as redness, pain after injection, tenderness to touch, firmness, swelling, lumps/bumps, bruising, itching and discoloration. Number analyzed is the number of participants with safety diary data available for analysis.|Up to 30 days after each treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine|Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. Analysis excludes 11 participants in the No-treatment Control group who did not receive JUVÉDERM® VOLBELLA® XC with Lidocaine.|||Participants|||Count of Participants
2528332|NCT03519204|Secondary|Procedural Pain Score|Procedural pain (pain during injection) was evaluated by the participant using an 11-point scale, where: 0=No pain to 10=Worst pain imaginable. Participants recorded procedural pain in safety diary for 30 days after initial treatment. Number analyzed is the number of participants with safety diary data available for analysis.|Up to 30 days after initial treatment with JUVÉDERM® VOLBELLA® XC with Lidocaine|Safety population included all participants randomized to the treatment group who received at least 1 study treatment and all participants randomized to the control group, as treated. Analysis excludes 11 participants in the No-treatment Control group who did not receive JUVÉDERM® VOLBELLA®.|||score on a scale||Standard Deviation|Mean
2528333|NCT03519204|Secondary|Percentage Change From Baseline in Lip Surface Area|Lips surface area was measured by 3D photography images. A positive percentage change from Baseline indicates improvement. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.|Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)|mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.|||percentage change in lip surface area||Full Range|Median
2528334|NCT03519204|Secondary|Change From Baseline in Overall Lip Volume|Overall lip volume was measured by 3-dimensional (3D) photography images. A positive change from Baseline indicates improvement. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.|Baseline to Month 3 Post Treatment ( JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)|mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.|||cubic centimeters (cc)||Full Range|Median
2528335|NCT03519204|Secondary|Percentage of Participants With a ≥1-point Increase (Improvement) Based on the Participant's Assessed 5-point LFS|Lip fullness was assessed by the participant using the 5-point LFS where: 0=Minimal (Flat or nearly flat contour, minimal red lip show), 1=Mild (Some red lip show; no lower lip pout), 2=Moderate (Moderate red lip show with slight lower lip pout), 3=Marked (Significant red lip show and lower lip pout), and 4=Very Marked (Very significant red lip show, lower lip pout, and upper lip pout). Improvement was defined as a ≥1-point increase in fullness from Baseline. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.|Baseline to Month 3 Post Treatment|mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of the primary variable. As per protocol, analysis for this Outcome Measure was for the Treatment arm only.|||percentage of participants||95% Confidence Interval|Number
2528348|NCT03513848|Secondary|Change in Patient Health Questionnaire - 9 (PHQ-9) Scores Over 4 Weeks of Treatment|The Patient Health Questionnaire - 9 (PHQ-9) is the gold standard measure of depression symptom severity. Range: 0-27. Higher scores indicate worse outcomes. We will assess change in PHQ-9 scores over 4 weeks of treatment [Week 2 through Week 6 of the study].|Week 2 and Week 6||||units on a scale||Standard Deviation|Mean
2528349|NCT03513848|Primary|Change in PTSD Checklist for DSM-5 (PCL-5) Scores Over 4 Weeks of Treatment|The PTSD Checklist for DSM-5 (PCL-5) is the gold standard measure of PTSD symptom severity. Range: 0-80. Higher scores indicate worse outcomes. We will assess change in PCL-5 scores over 4 weeks of treatment [Week 2 through Week 6 of the study].|Week 2 and Week 6||||units on a scale||Standard Deviation|Mean
2528336|NCT03519204|Primary|Percentage of Participants With a ≥1-point Increase (Improvement) on the Evaluating Investigator's (EI's) Assessed 5-point Lip Fullness Scale (LFS)|The investigator assessed the participant's lip fullness using the 5-point LFS where: 0=Minimal (Flat or nearly flat contour, minimal red lip show), 1=Mild (Some red lip show; no lower lip pout), 2=Moderate (Moderate red lip show with slight lower lip pout), 3=Marked (Significant red lip show and lower lip pout), and 4=Very Marked (Very significant red lip show, lower lip pout, and upper lip pout). Improvement was defined as a ≥1-point increase in fullness from Baseline. Number analyzed is the number of participants with data available for analysis at Baseline and Month 3.|Baseline to Month 3 Post Last Treatment (JUVÉDERM® VOLBELLA® XC with Lidocaine arm) or Month 3 Post Randomization (No-treatment Control arm)|mITT population included all participants who were randomized to study treatment (treatment group), received at least 1 study device treatment, and had baseline and at least 1 posttreatment assessment of primary variable, and who were randomized to no-treatment control group had baseline and at least 1 follow-up assessment of primary variable.|||percentage of participants||95% Confidence Interval|Number
2528337|NCT03518008|Primary|Overall Quality of Vision|Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated.|Day 8, each product|Safety Analysis Set|||units on a scale||Standard Deviation|Mean
2528338|NCT03516227|Primary|Changes From Baseline Autonomic Function (Frequency-domain of Heart Rate Variability) at 1 and 3 Months|"Heart rate variability (HRV) was used to represent the autonomic function and measured with Mind Media B.V. (-Nexus-10, Netherlands). Frequency-domain of HRV was analyzed using Kubios HRV software (Biosignal Analysis and Medical Imaging Group, Finland). Frequency domain indices of HRV were low frequency (LF), high frequency (HF), and total power (TP), which were reported with the unit of Measure ms^2. The higher scores mean a better outcome."|baseline, 1-month, and 3-month visits||||ms^2||Standard Deviation|Mean
2528339|NCT03516227|Primary|Changes From Baseline Autonomic Function (Time-domain of Heart Rate Variability) at 1 and 3 Months|"Heart rate variability (HRV) was used to represent the autonomic function and measured with Mind Media B.V. (-Nexus-10, Netherlands). Time-domain of HRV was analyzed using Kubios HRV software (Biosignal Analysis and Medical Imaging Group, Finland). Time-domain indices of HRV indices: standard deviation of normal to normal R-R intervals (SDNN) and root mean square of successive heartbeat interval differences (rMSSD), which were reported with the Unit of Measure ms. The higher scores mean a better outcome."|baseline, 1-month, and 3-month visits|Thirty-five participants completed all aspects of the study (19 intervention, 16 control)|||ms||Standard Deviation|Mean
2528340|NCT03516227|Primary|Changes From Baseline Capabilities of Activities of Daily Living at 1 and 3 Months|The 10-item Barthel Index (BI) was used to measure participants' capabilities in activities of daily living (ADLs) (feeding, bathing, grooming, dressing, transfers, and toilet use). BI score ranges from 0 to 100 with lower scores indicating lower ADLs capabilities.|baseline, 1-month, and 3-month visits|Thirty-five participants completed all aspects of the study (19 intervention, 16 control)|||score on a scale||Standard Deviation|Mean
2528341|NCT03516227|Primary|Changes From Baseline Cognitive Function at 1 and 3 Months|The Mini-Mental State Examination (MMSE) was used to measure patients' cognitive function. MMSE includes eleven items and consists of five facets orientation (space and time, registration, attention and calculation, recall, and language). The minimum value is 0 and the maximum value is 30. Lower scores represent a worse cognitive function.|baseline, 1-month, and 3-month visits|Thirty-five participants completed all aspects of the study (19 intervention, 16 control)|||score on a scale||Standard Error|Mean
2528342|NCT03516227|Primary|Changes From Baseline Psychological Distress (Anxiety and Depression) at 1 and 3 Months|The hospital anxiety and depression scale was a 14-item ordinal scale, used for participants to self-rate their psychological distress related to anxiety (7 items) and depression (7 items). Items are scored 0(no distress) to 3 (serious distress). Based on the findings from previous studies, scoring at or higher than the cut-off point of 8 out of 21, identified those with anxiety or depression. The minimum and maximum values of both anxiety and depression are 0 and 21, respectively. The higher scores mean a worse outcome.|baseline, 1-month, and 3-month visits|Thirty-five participants completed all aspects of the study (19 intervention, 16 control)|||score on a scale||Standard Deviation|Mean
2528343|NCT03514966|Secondary|Number of Participants With Adverse Events|Safety of MCCG, or adverse events, defined as symptoms or signs such as abdominal distention, nausea, or vomiting, were monitored closely during the MCCG procedure. Capsule retention (i.e., a capsule endoscope remaining in the gastrointestinal tract for more than two weeks or a capsule endoscope that requires directed intervention or therapy to aid its expulsion) was monitored and followed up for up to two weeks.|2 weeks||||participants|||Number
2528344|NCT03514966|Secondary|The Type of Positive Findings Detected by Magnetically Controlled Capsule Gastroscopy|Positive findings defined as any pathology detected by Magnetically controlled capsule gastroscopy (MCCG), including polyps, ulcer, gastric fundus varices, submucosal tumor, and carditis.|30 minutes||||findings|||Number
2528345|NCT03514966|Primary|Image Cleanliness of Gastric Cavity|The image cleanliness of gastric cavity of six primary anatomical landmarks of stomach (cardia, fundus, body, angulus, antrum, and pylorus) were recorded for evaluation. A 4-point grading scale was introduced to define the cleanliness as excellent (no adherent mucus and foam: score 4), good (mild mucus and foam but does not obscure vision: score 3), fair (considerable amount of mucus or foam present precluding a completely reliable examination: score 2) and poor (large amount of mucus or foam residue needing water to clear it: score 1)|30 minutes||||units on a scale||Standard Deviation|Mean
2528346|NCT03513848|Other Pre-specified|Change in Sleep Quality Over 4 Weeks of Treatment|Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) with PTSD addendum. We will assess change in sleep quality over 4 weeks of treatment [Week 2 through Week 6 of the study].|Week 2 and Week 6|||||||
2528347|NCT03513848|Other Pre-specified|Change in Sleep Duration Over 4 Weeks of Treatment|Sleep duration will be captured using actigraphy data collected by the wrist actigraphy monitor worn by subjects throughout the intervention. We will assess change in sleep duration over 4 weeks of treatment [Week 2 through Week 6 of the study].|Week 2 and Week 6|||||||
2528420|NCT03509948|Primary|Maximum Concentration (Cmax)||Pre-dose (within 60 minutes prior to dosing), up to 48 hours post-dose on Days 1-5|Pharmacokinetic (PK) Set: All randomized participants who received both doses of cytisine and had sufficient, protocol-compliant plasma concentration-time profiles.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2528350|NCT03513757|Secondary|Delirium|Pediatric Anesthesia Emergence Delirium (PAED) score greater than 12 as defined by Sikich and Lerman. 0 = no delirium, 20 = worst possible delirium; 5 categories scored from 0-4 additive for a maximum score of 20. Categories 1-3 are scored the same and categories ar scored inversely as described. 1. Child makes contact with caregiver, 2. child's actions are purposeful, 3. child is aware of his surroundings. For each of these category, score 0 for extremely, 1 for very much, 2 for quite a bit, 3 for just a little, 4 for not at all. The other 2 categories 4. Child is restless and 5 Child is inconsolable are scored as 0 for not at all, 1 for just a little, 2 for quite a bit, 3 for very much, 4 for extremely|up to 24 hours.||||participants|||Number
2528351|NCT03513757|Secondary|Irritability|behavior deemed inappropriate and a deviation from child's normal though parental observation obtained through follow-up phone call|up to 48 hours||||participants|||Number
2528352|NCT03513757|Secondary|Sleep Pattern|parental observation of deviation from child's normal habit obtained through follow-up phone call|up to 48 hours||||participants|||Number
2528353|NCT03513757|Secondary|Discharge Ready|minutes from completion of scan to discharge ready|up to 2 hours||||minutes||Inter-Quartile Range|Median
2528354|NCT03513757|Secondary|Oral/Enteral Intake|minutes from completion of scan to oral/enteral intake|up to 2 hours||||minutes||Inter-Quartile Range|Median
2528355|NCT03513757|Secondary|Eye Opening|minutes from completion of scan to spontaneous eye opening|up to 90 minutes||||minutes||Inter-Quartile Range|Median
2528356|NCT03513757|Secondary|Sevoflurane|sevoflurane induction time of 5 minutes|sevoflurane induction time up to 10 minutes||||participants|||Number
2528357|NCT03513757|Secondary|Nitrous Oxide|documentation of use|up to 10 minutes||||participants|||Number
2528358|NCT03513757|Secondary|Lidocaine Dose|lidocaine dose (mg/kg)|up to 90 minutes||||mg/kg||Inter-Quartile Range|Median
2528359|NCT03513757|Secondary|Glycopyrrolate Dose|glycopyrrolate dose (mcg/kg)|5 minutes||||mcg/kg||Inter-Quartile Range|Median
2528360|NCT03513757|Secondary|Dexmedetomidine Dose|dexmedetomidine dose (mcg/kg)|up to 90 minutes||||mcg/kg||Inter-Quartile Range|Median
2528361|NCT03513757|Secondary|Total Propofol Administered|total propofol administered (mg/kg)|up to 90 minutes||||mg/kg||Inter-Quartile Range|Median
2528362|NCT03513757|Primary|Efficiency of Propofol Dexmedetomidine Sedation Compared With Propofol Infusion|Time (minutes) from anesthesia start to readiness for discharge from the department to home or clinic.|through study completion, an average of 2 hours||||minutes||Inter-Quartile Range|Median
2528363|NCT03513588|Secondary|Peak-to-Trough Ratio (PTR) For PF-06865571|PTR of PF-06865571 on Day 14 was calculated as Cmax/Cmin. Geometric coefficients of variations were reported as percentages.|Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose|All randomized participants who received at least 1 dose of PF-06865571 (50 mg or 300 mg) and had Cmax and non-zero Cmin data for PTR evaluation.|||ratio of concentrations||Geometric Coefficient of Variation|Geometric Mean
2528364|NCT03513588|Secondary|Apparent Oral Clearance (CL/F) For PF-06865571|CL/F of PF-06865571 on Day 14 was calculated as Dose/AUCtau. Geometric coefficients of variations were reported as percentages.|Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose|All randomized participants who received at least 1 dose of PF-06865571 (50 mg or 300 mg) and had CL/F data.|||liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2528365|NCT03513588|Secondary|Minimum Plasma Concentration (Cmin) For PF-06865571|Cmin of PF-06865571 on Day 14 was observed directly from data. Geometric coefficients of variations were reported as percentages.|Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose|All randomized participants who received at least 1 dose of PF-06865571 (50 mg or 300 mg) and had Cmin data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2528366|NCT03513588|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) For PF-06865571|Tmax of PF-06865571 on Day 14 was observed directly from data as time of Cmax occurrence.|Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose|All randomized participants who received at least 1 dose of PF-06865571 (50 mg or 300 mg) and had Tmax data.|||hours||Full Range|Median
2528367|NCT03513588|Secondary|Area Under the Plasma Concentration‑Time Profile Over the Dosing Interval (AUCtau) For PF-06865571|AUCtau of PF-06865571 on Day 14 was obtained by linear/log trapezoidal method. The dosing interval (tau) was 12 hours. Geometric coefficients of variations were reported as percentages.|Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose|All randomized participants who received at least 1 dose of PF-06865571 (50 mg or 300 mg) and had AUCtau data.|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2528368|NCT03513588|Secondary|Maximum Plasma Concentration (Cmax) For PF-06865571|Cmax of PF-06865571 on Day 14 was observed directly from data. Geometric coefficients of variations were reported as percentages.|Day 14 pre-dose, and 1, 2, 3, 4, 6, 8, 12 hours post-dose|All randomized participants who received at least 1 dose of PF-06865571 (50 mg or 300 mg) and had Cmax data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2528369|NCT03513588|Secondary|Number of Participants With Electrocardiogram (ECG) Abnormalities|ECG categorical summarization criteria: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): >=140 milliseconds (msec), >=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% change when baseline is > 200 msec or >=50% change when baseline is less than or equal to (<=) 200 msec; 3) QTcF interval (heart rate corrected QT [time between the start of the ECG Q wave and the end of the T wave in the heart's electrical cycle] using Fridericia's formula): absolute value of >450 to 480 msec, >480 to 500 msec, >500 msec; a change from baseline of >30 to 60 msec or >60 msec.|From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)|All randomized participants who received at least 1 dose of study treatment (PF-06865571 or placebo).|||Participants|||Count of Participants
2528395|NCT03511105|Secondary|Change From Baseline Values for Hematology Parameter: Mean Corpuscular Hemogloblin (MCH)|Blood samples were collected for the analysis of hematology parameter: MCH. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at Day 2 and Day 9 (FU/EW)|All Subjects Population.|||Picograms||Standard Deviation|Mean
2528370|NCT03513588|Secondary|Number of Participants With Vital Sign Abnormalities|Vital sign categorical summarization criteria: 1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) <50 mmHg; 3) pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine DBP greater than or equal to (>=) 20 mmHg; 5) change from baseline (increase or decrease) in supine SBP >=30 mmHg.|From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)|All randomized participants who received at least 1 dose of study treatment (PF-06865571 or placebo).|||Participants|||Count of Participants
2528371|NCT03513588|Secondary|Number of Participants With Laboratory Test Abnormalities|Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes); chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, sodium, potassium, calcium, chloride, bicarbonate); urinalysis (urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, urine erythrocytes, urine leukocytes, hyaline casts); biomarker (total cholesterol, low-density and high-density lipoprotein cholesterol, triglycerides, fasting glucose). Participants with any of the laboratory test abnormalities were counted.|From first dose of study treatment up to 7-10 days after last dose (maximum of up to 24 days)|All randomized participants who received at least 1 dose of study treatment (PF-06865571 or placebo).|||Participants|||Count of Participants
2528372|NCT03513588|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity on or after the first dose of investigational product administration. AEs included both SAEs and non-serious AEs.|From first dose of study treatment up to 28-35 days after last dose (maximum of up to 49 days)|All randomized participants who received at least 1 dose of study treatment (PF-06865571 or placebo).|||Participants|||Count of Participants
2528373|NCT03513588|Primary|Relative Change From Baseline in Whole Liver Fat at Day 15 as Assessed by Magnetic Resonance Imaging (MRI) - Proton Density Fat Fraction (PDFF)|MRI-PDFF is an established method that enables quantification of fat content in the liver. The value of whole liver fat as assessed by MRI-PDFF is expressed in percentage and ranges from 0 to 100% with higher values representing higher liver fat level.|Baseline (Day 1), Day 15|All randomized participants who received at least 1 dose of study treatment (PF-06865571 or placebo) and had whole liver fat assessed at Day 15.|||percentage of whole liver fat||80% Confidence Interval|Least Squares Mean
2528374|NCT03512457|Secondary|Total Number of Melanomas Determined by Dermatologist Review of Concerning Lesion|The total number of melanomas identified by a dermatologist in women who found a concerning mole|7-months|Women who found a concerning mole at month 1 and month 3 and proceeded to have a skin examination by a dermatologist|||Melanomas|||Number
2528375|NCT03512457|Primary|Number of Participants That Performed a Skin Self-Examination at 3-months|The percentage of participants that performed skin self-examination at the 3-month time interval.|3-months|Women performing skin self-examination as reported 3 months after the intervention|||Participants|||Count of Participants
2528376|NCT03512067|Secondary|Assess for Frequency of Complications Related to the Use of EMV|With 20 patients we will have an 88% chance of seeing any complication (such as those defined by the safety criteria or any associated adverse event or serious adverse event) that occurs with a frequency of 10% or more.|8 Hours||||Participants|||Count of Participants
2528377|NCT03512067|Primary|Feasibility Evaluation|Total number of asynchronous breaths/hour during entrainment-based ventilation compared to baseline ventilation.|8 Hours||||breaths|||Number
2528378|NCT03512041|Primary|Discrete Sequence Production Task Score|The change from Visit 1 to Visit 7 in the average amount of time in seconds that a participant takes to complete pre-determined patterns of keypresses. A greater decrease in the Discrete Sequence Production Task score means more learning has occurred over the course of the study.|Visit 1 and Visit 7, approximately 1 week||||seconds||Standard Deviation|Mean
2528379|NCT03512041|Primary|Cup Stacking Score|The change from Visit 1 to Visit 7 in the average amount of time in seconds that a participant takes to stack and unstack pre-determined patterns of cups. A greater decrease in the cup stacking score means more learning has occurred over the course of the study.|Visit 1 and Visit 7, approximately 1 week||||seconds||Standard Deviation|Mean
2528380|NCT03512041|Primary|Balance Score|The change from Visit 1 to Visit 7 in the average amount of time in seconds that a participant maintains the stability platform within ±3° of horizontal position during 5 trials of 30 seconds each. A greater increase in the balance score means more learning has occurred over the course of the study.|Visit 1 and Visit 7, approximately 1 week||||seconds||Standard Deviation|Mean
2528381|NCT03512028|Primary|One-repetition Maximum of Wrist Extensors|The maximum amount of force (lbs) that a participant can generate while performing one wrist extension movement.|Pre-intervention, post-intervention (2 weeks later), and 1 month post-intervention follow-up||||lbs||Standard Deviation|Mean
2528382|NCT03511105|Secondary|Maximum Observed Plasma Concentration (Cmax) of GSK2798745|Blood samples were collected at indicated time points. The 2- and 26-hour blood samples were taken immediately before BAL sampling.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 6, 8, 12, 12.5, 13, 13.5, 14, 15, 24 and 26 hours post-dose|PK Population.|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2528383|NCT03511105|Secondary|Area Under the Curve During 26 Hours of GSK2798745|Blood samples were collected at indicated time points. The 2 and 26-hour blood samples were taken immediately before BAL sampling. Pharmacokinetic (PK) Population consists of all participants in the All Subjects Population who had at least one non-missing PK assessment (Non-quantifiable [NQ] values will be considered as non-missing values).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 6, 8, 12, 12.5, 13, 13.5, 14, 15, 24 and 26 hours post-dose|PK Population.|||Hour*nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2528384|NCT03511105|Secondary|Mean Forced Expiratory Volume in 1 Second (FEV1) and Mean Forced Vital Capacity (FVC)|Spirometric assessments including FEV1 and FVC were conducted from screening and up to Day 9. Measurements were made in triplicate and the highest FEV1 and FVC were recorded in the case report form (CRF). Mean FEV1 and FVC values along with 95% confidence interval (CI) at indicated timepoints has been presented. Baseline values is defined as the latest pre-treatment assessment with a non-missing value.|Baseline (Day 1, Pre-dose) pre-bronchodilator and at Day 1 (pre-bronchodilator and 6 Hours), at Day 2 (25.5 and 30 Hours) and Day 9 pre-bronchodilator|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Liters||95% Confidence Interval|Mean
2528385|NCT03511105|Secondary|Number of Participants With Positive Fecal Occult Blood Test (FOBT) Data|Based on the preclinical finding of gastric erosions, FOBT was performed before and after dosing at screening and follow-up and any positive hemoglobin measurement was recorded as potentially clinically important. Participants with at least one recorded result has been reported.|At Day 9|All Subjects Population.|||Participants|||Count of Participants
2528386|NCT03511105|Secondary|Change From Baseline in Temperature|Temperature was measured at indicated time points in supine position after 5 minutes rest for the participants. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 1, 2, 6, 8, 12, 14, 30 hours and Day 9 (FU/EW)|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Degree celsius||Standard Deviation|Mean
2528387|NCT03511105|Secondary|Change From Baseline in Heart Rate|Heart rate was measured at indicated time points in supine position after 5 minutes rest for the participants. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 1, 6, 12, 14, 30 hours and Day 9 (FU/EW)|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Beats per minute||Standard Deviation|Mean
2528388|NCT03511105|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|The DBP and SBP were measured in participants in a semi-supine position after 5 minutes rest. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at 1, 6, 12, 14, 30 hours and Day 9 (FU/EW)|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimeters of mercury||Standard Deviation|Mean
2528389|NCT03511105|Secondary|Number of Participants With Abnormal Findings During Physical Examinations|A complete physical examination included, at a minimum, assessments of the skin, cardiovascular, respiratory, gastrointestinal and neurological systems. Height and weight were also measured and recorded. A brief physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen).|Up to Day 9 (FU/EW)|Safety Population. This analysis was not planned and data was not collected and captured in the database.||||||
2528390|NCT03511105|Secondary|Number of Participants With Worst Case Post Baseline Abnormal Electrocardiogram (ECG) Findings|A single 12-lead ECG was performed at the specified timepoints during the study where the participant was instructed to be in semi-recumbent position for 5 minutes before obtaining the ECG. An ECG machine that automatically calculated the heart rate and measures like the PR, QRS, QT, and corrected QT intervals. Number of participants with worst-case post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. The decision if an ECG abnormality is clinically significant or not-clinically significant was in the discretion of the investigator, based on her/his clinical judgement. Baseline values is defined as the latest pre-treatment assessment with a non-missing value.|Up to Day 9 (FU/EW)|All Subjects Population.|||Participants|||Count of Participants
2528391|NCT03511105|Secondary|Change From Baseline in Urine Specific Gravity|Urine samples were collected for the analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The dipstick test gives results in a semi-quantitative manner. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at Day 2 and Day 9 (FU/EW)|All Subjects Population.|||Ratio||Standard Deviation|Mean
2528392|NCT03511105|Secondary|Change From Baseline in Urine Potential of Hydrogen (pH)|Urine samples were collected for measurement of urine pH at indicated time points. pH is a measure of hydrogen ion concentration and used to determine the acidity or alkalinity of urine. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at Day 2 and Day 9 (FU/EW)|All Subjects Population.|||pH||Standard Deviation|Mean
2528393|NCT03511105|Secondary|Change From Baseline Values for Hematology Parameter: Red Blood Cell (RBC) Count|Blood samples were collected for the analysis of hematology parameter: RBC count. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1)and at Day 2 and Day 9 (FU/EW)|All Subjects Population.|||Tera cells per liter||Standard Deviation|Mean
2528394|NCT03511105|Secondary|Change From Baseline Values for Hematology Parameter: Mean Corpuscular Volume (MCV)|Blood samples were collected for the analysis of hematology parameter: MCV. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at Day 2 and Day 9 (FU/EW)|All Subjects Population.|||Femtoliters||Standard Deviation|Mean
2528421|NCT03509883|Secondary|Number of Participants With Out-of Range ECG Evaluations|Number of participants with out-of-range ECG changes. ECG intervals are measured in milliseconds (msec)|Day 1 to Day 8|All treated participants|||participants|||Number
2528396|NCT03511105|Secondary|Change From Baseline Values for Hematology Parameters: Hematocrit and Reticulocytes|Blood samples were collected for the analysis of hematology parameters: hematocrit and reticulocytes. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at Day 2 and Day 9 (FU/EW)|All Subjects Population.|||Percentage of red blood cells in blood||Standard Deviation|Mean
2528397|NCT03511105|Secondary|Change From Baseline Values for Hematology Parameter: Hemoglobin|Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at Day 2 and Day 9 (FU/EW)|All Subjects Population.|||Grams per liter||Standard Deviation|Mean
2528398|NCT03511105|Secondary|Change From Baseline Values for Hematology Parameters|Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell (WBC) count. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at Day 2 and Day 9 (FU/EW)|All Subjects Population.|||Giga cells per liter||Standard Deviation|Mean
2528399|NCT03511105|Secondary|Change From Baseline Values for Clinical Chemistry Parameter-Total Protein|Blood samples were collected for the analysis of clinical chemistry parameter- total protein. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at Day 2 and Day 9|All Subjects Population.|||Grams per liter||Standard Deviation|Mean
2528400|NCT03511105|Secondary|Change From Baseline Values for Clinical Chemistry Parameter-C Reactive Protein (CRP)|Blood samples were collected for the analysis of clinical chemistry parameter- CRP. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at Day 2 and Day 9 (FU/EW)|All Subjects Population.|||Milligrams per liter||Standard Deviation|Mean
2528401|NCT03511105|Secondary|Change From Baseline Values for Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)|Blood samples were collected for the analysis of clinical chemistry parameters including calcium, glucose, potassium, sodium and urea/BUN. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at Day 2 and Day 9 (FU/EW)|All Subjects Population.|||Millimoles per liter||Standard Deviation|Mean
2528402|NCT03511105|Secondary|Change From Baseline Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine|Blood samples were collected for the analysis of clinical chemistry parameters direct bilirubin, total bilirubin and creatinine. Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at Day 2 and Day 9 (FU/EW)|All Subjects Population.|||Micromoles per liter||Standard Deviation|Mean
2528403|NCT03511105|Secondary|Change From Baseline Values for Clinical Chemistry Parameters|Blood samples were collected for the analysis of clinical chemistry parameters including alkaline phosphate (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine kinase (CK). Baseline values were defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at Day 2 and Day 9 (FU/EW)|All Subjects Population.|||International units per liter||Standard Deviation|Mean
2528404|NCT03511105|Secondary|Number of Participants Reporting Serious Adverse Events (SAEs) and Non-SAEs|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect and other important medical events. All Subjects Population consists of all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participant actually received. SAEs and non-SAEs were analyzed up to follow-up or early withdrawal (FU/EW) of Day 9.|Up to Day 9 (FU/EW)|All Subjects Population.|||Participants|||Count of Participants
2528405|NCT03511105|Secondary|Baseline Adjusted Differential Cell Count of Neutrophils in BAL Samples at 24 Hours After Segmental LPS Challenge (26 Hours Post-first Dose)|Participants underwent segmental challenge to the lungs, via bronchoscopy, at 2 hours after the first dose of investigational medicinal product. BAL samples were taken, via bronchoscopy and total neutrophil cell count was measured. Baseline samples were taken immediately before the LPS and saline challenges, from a segment in the left lower lobe, and post-challenge samples were taken at 24 hour (26 hours post-first dose) after the LPS and saline challenges, from the challenged segments. Median and 95% CrI at the indicated time point has been presented.|Baseline and at 26 hours post-first dose|Evaluable Population.|||Percentage of total cell count||95% Confidence Interval|Median
2528406|NCT03511105|Secondary|Baseline Adjusted Total Cell Count of Neutrophils in BAL Samples at 24 Hours After Segmental LPS Challenge (26 Hours Post-first Dose)|Participants underwent segmental challenge to the lungs, via bronchoscopy, at 2 hours (Baseline) after the first dose of investigational medicinal product. BAL samples were taken, via bronchoscopy and total neutrophil cell count was measured. Baseline samples were taken immediately before the LPS and saline challenges, from a segment in the left lower lobe, and post-challenge samples were taken at 24 hours (26 hours post-first dose) after the LPS and saline challenges, from the challenged segments. Median and 95% CrI at indicated time point has been presented.|Baseline and at 26 hours post-first dose|Evaluable Population.|||10^6 cells per milliliter||95% Confidence Interval|Median
2528419|NCT03509948|Primary|Area Under the Concentration Versus Time Curve (AUC) Extrapolated to Infinity (AUC0-∞)||Pre-dose (within 60 minutes prior to dosing) up to 48 hours post dose on Days 1-5|PK Set: All randomized participants who received both doses of cytisine and had sufficient, protocol-compliant plasma concentration-time profiles.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2528407|NCT03511105|Primary|Baseline Adjusted Total Protein Concentration in Broncho-alveolar (BAL) Samples at 24 Hours After Segmental LPS Challenge (26 Hours Post-first Dose)|Participants underwent segmental challenge to lungs, via bronchoscopy, at 2 hours after first dose of investigational medicinal product. BAL samples were taken, via bronchoscopy and total protein was measured. Baseline (2 hours) samples were taken immediately before the LPS and saline challenges, from a segment in the left lower lobe, and post-challenge samples were taken at 24 hours (26 hours post-first dose) after the LPS and saline challenges, from the challenged segments. Evaluable Population consists of all participants for whom results of the primary analysis can be determined i.e. all randomized participants who received two correct doses of study treatment, received LPS and saline segmental challenge (in contralateral lobes) and for which results of both baseline (2 hours) and LPS lobe (26 hours) BAL samples are evaluable. This population will be based on treatment the participant actually received. Median and 95% credible interval (CrI) has been presented.|Baseline and at 26 hours post-first dose|Evaluable Population.|||Milligrams per liter||95% Confidence Interval|Median
2528408|NCT03510273|Secondary|Treatment Failure|Analysis of cervical photos will be a qualitative comparison of the characteristics of the uterine cervix and the pre-cancerous lesions at Visit 1 (enrollment) in women whose treatment resulted in disappearance of lesions and women with persistent pre-cancerous lesions after 12 months. The evaluation will examine what features or cervical conditions prior to treatment might be related to disappearance or persistence of lesions, such as shape of the cervix, size and location of the lesions, etc. Chi-square or Fisher's exact test will be used to confirm whether there are any differences by these features.|12 months after treatment||2020-04-30|04/2020||||
2528409|NCT03510273|Secondary|Disappearance of Lesions|To calculate rates of disappearance of lesions, we will include women with histologically-confirmed cervical squamous intraepithelial neoplasia 2-3 lesions. The 12 month rate of disappearance of cervical squamous intraepithelial neoplasia 2-3 lesions will be calculated by dividing the number of eligible women who had no evidence of cervical squamous intraepithelial neoplasia 2-3 at 12 months after undergoing thermal coagulation for the treatment of their cervical squamous intraepithelial neoplasia 2-3 lesions (numerator), divided by those women evaluated at 12 months (denominator). Analysis will include considering potential confounding factors such as clinic and provider as well as drop-out rates. Chi-square or Fisher's exact test will be used to confirm whether there are differences in rates by these potential confounding factors.|12 months after treatment|||||||
2528410|NCT03510273|Primary|Acceptability of Treatment by Women|"Level of pain women experienced during the thermal coagulation procedure will be calculated by the number and percent of women indicating minimal to worst possible levels of pain using the Wong-Baker FACES® pain rating scale. Women's acceptability will also be assessed by asking if they would recommend the Liger Thermocoagulator treatment to a friend or relative who needed similar treatment as well as reasons for her response.~Wong-Baker FACES® pain rating scale:~MINIMUM value: 0 (no hurt = best outcome) Value: 2 (hurts little bit) Value: 4 (hurts little more) Value: 6 (hurts even more) Value: 8 (hurts lot more) MAXIMUM value: 10 (hurts whole lot = worst outcome)"|Immediately after treatment|Not applicable; all participants were included.|||Participants|||Count of Participants
2528411|NCT03510273|Primary|Short-term Safety Concerns for Ablative Treatment|Reported a short-term adverse event. Note: Participants could report more than one discomfort or problem experienced.|1 month after treatment|All participants were included. Note: Participants could report more than one discomfort or problem experienced.|||participants|||Number
2528412|NCT03509948|Secondary|Number of Participants With Clinically Significant Biochemistry, Hematology, Urinalysis, and/or 12-lead Electrocardiogram (ECG) Values||Screening through Day 5|Safety Set: All randomized participants who received at least 1 dose of cytisine.|||Participants|||Count of Participants
2528413|NCT03509948|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Withdrawal of Study Drug|An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) is defined as an AE that: results in death; is life-threatening; requires hospitalization or prolongs existing inpatient hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medical event which requires medical intervention to prevent any of the above outcomes. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product. Relationship of the TEAE to study drug was evaluated as: definite, probably, possible, unlikely, or not related.|Baseline (Day 0) through Day 5 plus 6-8 days|Safety Set: All randomized participants who received at least 1 dose of cytisine.|||Participants|||Count of Participants
2528414|NCT03509948|Secondary|AUC From Time of Dosing to Last Measurable Concentration (AUC0-t)||Pre-dose (within 60 minutes prior to dosing) up to 48 hours post dose on Days 1-5|PK Set: All randomized participants who received both doses of cytisine and had sufficient, protocol-compliant plasma concentration-time profiles.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2528415|NCT03509948|Secondary|Terminal Elimination Half-Life (T1/2)||Pre-dose (within 60 minutes prior to dosing) up to 48 hours post dose on Days 1-5|PK Set: All randomized participants who received both doses of cytisine and had sufficient, protocol-compliant plasma concentration-time profiles.|||hours||Standard Deviation|Mean
2528416|NCT03509948|Secondary|Time to Cmax (Tmax)||Pre-dose (within 60 minutes prior to dosing) up to 48 hours post dose on Days 1-5|PK Set: All randomized participants who received both doses of cytisine and had sufficient, protocol-compliant plasma concentration-time profiles.|||hours||Full Range|Median
2528417|NCT03509948|Primary|Percent of Total Cytisine Excreted in Urine Over 48 Hours (Ae0-48h%)||Pre-dose (within 60 minutes prior to dosing) up to 48 hours post dose on Days 1-5|Urine Excretion Set: All participants who received both doses of cytisine and had sufficient, protocol-compliant plasma concentration-time profiles.|||percent of cytisine excreted in urine||Standard Deviation|Mean
2528418|NCT03509948|Primary|Total Cytisine Excreted in Urine Over 48 Hours (Ae0-48h)||Pre-dose (within 60 minutes prior to dosing) up to 48 hours post dose on Days 1-5|Urine Excretion Set: All participants who received both doses of cytisine and had sufficient, protocol-compliant plasma concentration-time profiles.|||mg||Geometric Coefficient of Variation|Geometric Mean
2547892|NCT02896595|Secondary|Intraoperative Hemodynamics|heart rate (beats per minute)|Up to 270 minutes|Data was not collected||||||
2528422|NCT03509883|Secondary|Number of Participants With Out-of Range Vital Signs: Temperature|"Number of participants with Out-of Range temperature changes as follows:~Temperature is measured in Degrees centigrade (°C)~>38.3°C Change from baseline > 1.6°C >38.3°C or change from baseline > 1.6°C"|Day 1 to Day 8|All treated participants|||participants|||Number
2528423|NCT03509883|Secondary|Number of Participants With Out-of Range Vital Signs: Respiration Rate|"Number of participants with Out-of Range respiration rate changes as follows:~Respiration Rate is measured by number of respiration per min (rpm) > 16 rpm Change from baseline >10 rpm > 16 rpm or change from baseline > 10 rpm"|Day 1 to Day 8|All treated participants|||participants|||Number
2528424|NCT03509883|Secondary|Number of Participants With Out-of Range Vital Signs: Heart Rate (Bpm)|"Number of participants with Out-of Range Heart Rate changes as follows:~< 55 and change from baseline < -16 >100 and change from baseline > 10"|Day 1 to Day 8|All treated participants|||participants|||Number
2528425|NCT03509883|Secondary|Number of Participants With Out-of Range Vital Signs: Blood Pressure|"Number of participants with Out-of Range Blood Pressure changes as follows:~Systolic Blood Pressure (SBP) mmHg < 90 and change from baseline < -20 > 140 and change from baseline > 20~Diastolic Blood Pressure (DBP) mmHg < 55 and change from baseline < -10 > 90 and change from baseline > 10"|Day 1 to Day 8|All treated participants|||participants|||Number
2528426|NCT03509883|Secondary|Number of Participants With a Given Clinical Laboratory Abnormality|Assessment of clinical laboratory abnormalities|Day 1 to Day 8|All Treated Participants|||participants|||Number
2528427|NCT03509883|Secondary|Physical Measurement - Body Mass Index (BMI)|Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive. Body mass index = weight (kg)/[height(m)]2.|Pre-treatment Screening to Day 8|All treated participants|||kilograms / Meters² (kg/m²)||Standard Deviation|Mean
2528428|NCT03509883|Secondary|Physical Measurement - Weight|Average weight of all participants treated|Pre-treatment screening to Day 8|All treated participants|||kilograms (kg)||Standard Deviation|Mean
2528429|NCT03509883|Secondary|Physical Measurement - Height|Average height of all participants treated|Pre-treatment Screening|All treated participants|||centimeter (cm)||Standard Deviation|Mean
2528430|NCT03509883|Secondary|Number of Participants With Adverse Events Regardless of Causality, Serious Adverse Events and Adverse Events Leading to Discontinuation|Adverse events regardless of causality, Serious Adverse Events & Adverse events leading to discontinuation|Day 1 to Day 38|All Treated Participants|||Participants|||Number
2528431|NCT03509883|Secondary|Frel - Relative Bioavailability|The relative bioavailability of 0.1mg apixaban sprinkle capsules as compared to 0.5mg tablet formulation|Day 1 to Day 8|All Treated Participants|||Percentage||Geometric Coefficient of Variation|Geometric Mean
2528432|NCT03509883|Secondary|T-Half - Terminal Plasma Half Life.|Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of time required to reach to half of plasma concentration|Day 1 to Day 8|All Treated Participants|||h (hours)||Geometric Coefficient of Variation|Geometric Mean
2528433|NCT03509883|Secondary|Tmax - Time of Maximum Observed Plasma Concentration|Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms time of maximum concentration|Day 1 to Day 8|All Treated Participants|||h (hours)||Geometric Coefficient of Variation|Geometric Mean
2528434|NCT03509883|Primary|AUC (INF) - Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time|Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time|Day 1 to Day 8|All Treated Participants|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2528435|NCT03509883|Primary|AUC (0-T) - Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration|Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of plasma concentration and time|Day 1 to Day 8|All Treated Participants|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2528436|NCT03509883|Primary|Concentration as Measured by Maximum Observed Plasma Concentration (Cmax)|Assessment of bioavailability of apixaban 0.5mg tablets relative to apixaban 0.1mg Sprinkle in terms of concentration|Day 1 to Day 8|All Treated Participants|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2528437|NCT03509766|Secondary|Skin Prick Techniques/Methodology Ratio|Compare 1mg/ml versus 6mg/ml histamine base for Duotip II twist method. Maximum wheal diameter is measured for each concentration.|15 minutes|All 24 subjects received DuoTip II with both 1mg/ml and 6mg/ml histamine. This 24 vs 24 SPT in 24 total subjects.|||ratio||Standard Deviation|Mean
2528438|NCT03509766|Primary|Sensitivity|Sensitivity is calculated by dividing the true positive wheals divided by true positives plus false negatives and multiplying by 100. For example one false negative out of 24 tests equals a sensitivity of 95.8%.|15 minutes||||percentage of tests true positive|||Number
2528439|NCT03509766|Primary|Wheal Response|Compare Wheal response among devices using 1mm precision. SPT test will be read at 15 min time point. The maximum wheal diameter will be recorded for each of ten skin prick devices. 3mm (and 2mm above negative control) qualify as a positive test.|15 minutes||||mm||Standard Deviation|Mean
2528440|NCT03508843|Primary|Number of Participants Who Properly Position the Child Restraint in the Vehicle|proper positioning of the child restraint in the vehicle|immediately (< 5 minutes) after the car seat is installed|comparison to baseline|||Participants|||Count of Participants
2528441|NCT03508843|Primary|Number of Participants Who Install the Child Restraint Accurately Into the Vehicle|accurate installation of the child restraint into the vehicle|immediately (< 5 minutes) after the car seat is installed|comparison to baseline|||Participants|||Count of Participants
2528442|NCT03508843|Primary|Number of Participants Who Accurately Select a Safe Child Restraint|accurate selection of a safe child restraint that was proper for the child's age and size|immediately (< 5 minutes) after the car seat is installed|comparison to baseline|||Participants|||Count of Participants
2528443|NCT03508661|Secondary|Oldenburg Burnout Inventory (OLBI)|The Oldenburg Burnout Inventory (OLBI) is a 16-item measure of burnout that assesses levels of exhaustion and disengagement in work populations. Items were adapted and reviewed by project investigators for use within the support group leader population. Items are scored on a 4-point scale from 1 (strongly disagree) to 4 (strongly agree). The total values range from 16 to 64, with higher score representing higher level of exhaustion and disengagement. The difference between pre- and post-trial means was calculated.|baseline and 13 weeks||||score on a scale||95% Confidence Interval|Mean
2528444|NCT03508661|Secondary|Patient Reported Outcomes Measurement Information System (PROMIS-29) Profile Version 2.0|The Patient Reported Outcomes Measurement Information System (PROMIS-29) measure contains 29 items, which include four items each for domains reflecting physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to perform social roles, plus a single item on pain intensity. Total raw scores are obtained by summing item scores for each domain, which are converted into T-scores standardized from the general US population (mean=50, SD=10). High scores represent more of the domain being measured. Thus, on symptom-oriented domains, higher scores represent worse symptomatology. On the function-oriented domains, higher scores represent better functioning.The difference of pre- and post-trial means was calculated.|baseline and 13 weeks||||score on a scale||95% Confidence Interval|Mean
2528445|NCT03508661|Secondary|Personal Health Questionnaire (PHQ-8)|The Personal Health Questionnaire (PHQ-8) is a self-administered 8-item scale to assess depression that has been validated for use in populations with SSc. Items are rated on a 4-point Likert scale (not at all, several days, more than half the days, nearly every day). The total values range from 0 to 24, with higher scores indicating higher levels of depressive symptoms. The difference of pre- and post-trial means was calculated.|baseline and 13 weeks||||score on a scale||95% Confidence Interval|Mean
2528446|NCT03508661|Secondary|The Scleroderma Support Group Leader Self-efficacy Scale (SSGLSS)|The SSGLSS consists of 32 core items that assess the confidence of SSc support group leaders to carry out tasks necessary for leading a support group successfully. Items are scored on a 6-point scale ranging from Strongly Disagree to Strongly Agree (scored 0-5). Possible total scores range from 0 to 160 with higher scores indicating greater self-efficacy.|13 weeks||||units on a scale||95% Confidence Interval|Mean
2528447|NCT03508661|Primary|Number of Participants That Reported no Technological Problems|Log of technological problems reported by staff and participants will be maintained and reported descriptively.|13 weeks||||participants|||Number
2528448|NCT03508661|Primary|Percentage of Topics Adequately Covered in the Sessions|Intervention fidelity will be evaluated through the observation of entire sessions for a randomly selected sample of 25% of video-recorded sessions. Raters will evaluate adherence to each session's goals and content using a checklist coding system based on a standardized format. Two raters reviewed 54 topics from 7 randomly chosen modules from both training groups to examine if the contents were adequately covered.|13 weeks||||percentage|Topics||Number
2528449|NCT03508661|Primary|Duration of Management of Online Training Group Participation|The challenges related to the management of online training group participation encountered by study personnel, including assisting participants with accessing GoToMeeting and managing Qualtrics for data collection. Time required for management of training groups could not be assigned to individual participants as sometimes the group needed support, and other times an individual did. Thus, the number presented represents the total time required.|13 weeks||||hours|||Number
2528450|NCT03508661|Primary|Personnel Requirements|Time logs completed by research staff will be used to assess personnel requirements for the full-scale trial.|13 weeks||||personnel required|||Number
2528451|NCT03508661|Primary|Participant Feedback on Ease of Use of the Online Forum|Participant Interviews. Participants were asked to report the overall technological difficulties that they experienced using the online forum.|13 weeks||||Participants|||Count of Participants
2528452|NCT03508661|Primary|Participant Feedback on Ease of Use of the Go-To Videoconferencing Program|Participant Interviews. Participants were asked if they encountered difficulties during the use of Go-To videoconferencing program. Number of participants who found no difficulty in using the program is reported.|13 weeks||||Participants|||Count of Participants
2528453|NCT03508661|Primary|Participant Feedback on Usability of Program Materials|Participant Interviews. Participants were asked if they found the program to be useful. The number of participants who found the program materials to be useful were recorded|13 week||||Participants|||Count of Participants
2528454|NCT03508050|Secondary|Quality of Lung Collapse (Clinical) at 20 Minutes|A clinical evaluation, by the thoracic surgeon, of the quality of the surgical exposure following lung collapse using a visual scale graduated from 1 to 3. Score 1 = No lung collapse, Score 2 = Partial lung collapse, Score 3 = Complete lung collapse Scale title: Visual grading scale of lung collapse Higher score means a better outcome|20 minutes after pleural opening||||Participants|||Count of Participants
2528455|NCT03508050|Secondary|Quality of Lung Collapse (Clinical) at 10 Minutes|A clinical evaluation, by the thoracic surgeon, of the quality of the surgical exposure following lung collapse using a visual scale graduated from 1 to 3. Score 1 = No lung collapse, Score 2 = Partial lung collapse, Score 3 = Complete lung collapse Scale title: Visual grading scale of lung collapse Higher score means a better outcome|10 minutes after pleural opening||||Participants|||Count of Participants
2528456|NCT03508050|Secondary|Quality of Lung Collapse (Clinical) at 0 Minute|A clinical evaluation, by the thoracic surgeon, of the quality of the surgical exposure following lung collapse using a visual scale graduated from 1 to 3. Score 1 = No lung collapse, Score 2 = Partial lung collapse, Score 3 = Complete lung collapse Scale title: Visual grading scale of lung collapse Higher score means a better outcome|At pleural opening (0 minute)||||Participants|||Count of Participants
2528457|NCT03508050|Secondary|Postoperative Atelectasis|Number of atelectasis detected by Postoperative X-Ray|End of hospitalization||||Participants|||Count of Participants
2528458|NCT03508050|Secondary|Surgery Duration|Time required for completion of the surgery|From the beginning of surgery (pleural opening) until 120 minutes||||minutes||Standard Deviation|Mean
2528459|NCT03508050|Secondary|Quality of Oxygenation During One-lung Ventilation (SaO2)|An evaluation of the SaO2during one-lung ventilation|25 minutes after pleural opening||||% of oxygen saturation||Standard Deviation|Mean
2528460|NCT03508050|Secondary|Quality of Oxygenation During One-lung Ventilation (PaO2 )|An evaluation of the PaO2 during one-lung ventilation|25 minutes after pleural opening||||mmHg||Standard Deviation|Mean
2528461|NCT03508050|Secondary|Optimization of Lung Collapse|Number of Participants needing Other Interventions to Optimize Lung Collapse|From the beginning of surgery (pleural opening) until 60 minutes||||Participants|||Count of Participants
2528462|NCT03508050|Secondary|O2 Concentration of Expired Air at the Beginning of One-lung Ventilation|A measure of the O2 concentration of the expiratory air at the beginning of one-lung ventilation (OLV)|From the beginning of one-lung ventilation and lasting 60 seconds||||% of oxygen||Standard Deviation|Mean
2528468|NCT03507569|Primary|Plasma Concentrations of RO7017773||Baseline up to 48 hrs|This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.||||||
2528469|NCT03507569|Primary|Percentage of Brain Alpha5-Containing GABA-A Receptors Occupied by RO7017773||Baseline up to 48 hours (hrs)|This data/information can potentially be used to re-identify trial participants due to the low sample size, Therefore, this data will not be disclosed in the interest of maintaining participant confidentiality.||||||
2528470|NCT03506425|Secondary|Change in Urine Isoprostane Levels, an Oxidative Stress Marker|Effects of ALS and/or Triheptanoin on urine isoprostane levels (a marker of oxidative stress) at month 1|baseline, 1 month|One subject in Group 2 did not complete the month 1 visit.|||ng/mg||Standard Deviation|Mean
2528471|NCT03506425|Secondary|Change in NAA/Cr Ratio From Motor Cortex as Measured by Magnetic Resonance Spectroscopy|Effects of time, Triheptanoin on NAA/Cr (N-acetylaspartate/creatine) ratio from motor cortex|baseline, 6 months|One subject in Group 2 did not complete the second MRS measure. Group 3 did not receive treatment; therefore, no data was collected on Group 3 for this outcome measure.|||NAA/Cr||Standard Deviation|Mean
2528472|NCT03506425|Primary|ALS Functional Rating Scale-revised Version (ALSFRS-R) Slope|"Amyotrophic lateral sclerosis functional rating scale-revised version (ALSFRS-R) is used to determine patients' assessments of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS and each is scored between 0 (no function at all) and 4 (normal function). Thus the overall score for this measure can range from 0 to 48, with higher scores indicating more normal function. The test-retest reliability is greater than 0.88 for all 12 items/activities. The ALSFRS-R declines linearly with time over a wide range during the course of ALS and the minimum clinically significant change in this scale is said to be 20%. The primary analysis in this study is the slope of the ALSFRS-R during treatment compared to pre-treatment. Pre-treatment slope for each participant will be estimated as follows: (48-enrollment ALSFRS-R)/months since symptom onset. This frequently used pre-slope method is simple and inexpensive, and can predict disease progression."|baseline, 6 months|For the primary outcome measure, patients in Arm 1 and Arm 2 were combined (since patients in both these groups received at least 5 months of Triheptanoin). The primary outcome comparison is not between these arms, but between all these Triheptanoin-treated patients’ ALSFRS-R progression during the study compared to progression before the study.|||points per month||Standard Deviation|Mean
2528473|NCT03506347|Primary|Vancomycin Concentration in Bone|Mean vancomycin concentration in bone measured in ug/g at surgical closure|Approximately 60 minutes post surgical incision||||ug/g|bone|Standard Deviation|Mean
2528474|NCT03506347|Primary|Vancomycin Concentration in Fat|Mean vancomycin concentration in fat measured in ug/g at surgical closure|Approximately 60 minutes post surgical incision||||ug/g|fat|Standard Deviation|Mean
2528475|NCT03506295|Secondary|Biopsy Size|Each biopsy obtained will be assessed by pathologist for size of sample obtained.|From time of randomization until acquisition of results from pathology, assessed up to 12 months.|this analysis was removed from the protocol and data were not collected||||crypbiopsies||
2528476|NCT03506295|Secondary|Biopsy Specimen Quality|Each biopsy obtained will be assessed by pathologist for quality of sample obtained and injury patterns identified|From time of randomization until acquisition of results from pathology, assessed up to 12 months.|this analysis was removed from the protocol and data were not collected||||crypbiopsies||
2528477|NCT03506295|Secondary|Number of Biopsies That Required Additional Interventions to Manage Bleeding|Cold saline, patient positioning, rigid bronchoscopy, embolization, ICU admission etc. are techniques to control bleeding after cryobiopsy. Use of these techniques will be recorded.|From time of randomization up to 120 minutes.|All participants received both interventions during the same procedure.|||biopsies|cryobiopsies||Number
2528478|NCT03506295|Secondary|Grade of Bleeding|"0)No or only scant bleeding, stops spontaneously~Mild, stops with suction or iced saline or scope tamponade~Modest, stops with balloon blockade < 3 min~Moderate,requires bleeding side down in addition to balloon~Severe, requires prolonged blockade (> 3 min)~Very severe,soils opposite lung, hypoxemia, increase level of care, additional procedures All participants received both interventions during the same procedure."|From time of randomization up to 120 minutes.|All participants received both interventions during the same procedure.|||cryobiopsies|cryobiopsies||Count of Units
2528479|NCT03506295|Primary|Time to Achieve Hemostasis After Obtaining Cryobiopsy|"This is defined as time from when the bronchoscope and cryoprobe are removed en bloc after obtaining the cryobiopsy to the time when it is determined to be safe to proceed to next cryobiopsy(Ready for next biopsy)."|From time of randomization up to 120 minutes.|All participants received both interventions during the same procedure.|||seconds|biopsies|Full Range|Mean
2528480|NCT03505372|Secondary|Types of Changes in Surgical Management Based on CESM|Investigators will evaluate how incidental findings seen on CESM impact the surgical management of patients diagnosed with ADH. The initial surgical management documented in the clinical report (created before CESM performed) will be compared with the surgical management documented in the medical record after the CESM was performed to determine the change.|3 months|Images were performed but outcome data was not collected and therefore we cannot provide any analysis.||||||
2528481|NCT03505372|Primary|CESM's Ability to Predict Upgrade Rates of Biopsy Proven ADH at Surgical Excision|Investigators will evaluate whether enhancement on CESM can predict which cases of ADH upgrade at the time of surgical excision.|3 months|Images were performed but outcome data was not collected and therefore we cannot provide any analysis.||||||
2528482|NCT03504189|Other Pre-specified|Safety Measures|Evaluate device related adverse events|Through study completion, an average of 1 hour||||Participants|||Count of Participants
2528483|NCT03504189|Secondary|Uterine Contractions|Compare uterine contractions from Pregsense™ versus CTG.|30 Minutes|Uterine Contraction information was eventually not collected AT ALL, therefore no population to describe.||||||
2528484|NCT03504189|Primary|Maternal Heart Rate|Provide evidence of safety and agreement between MHR collected via the PregSense™ and the standard of care devices (i.e. CTG)|30 MInutes||||bpm||Standard Deviation|Mean
2528485|NCT03504189|Primary|Fetal Heart Rate|Provide evidence of safety and FHR agreement between PregSense™ and the standard of care devices (i.e. CTG)|30 Minutes||||bpm||Standard Deviation|Mean
2538717|NCT03094325|Primary|Septal Thickness Measured Before Cardiopulmonary Bypass|Center tendency parameters(mean, standard deviation)|1 Day||||millimeters||Standard Deviation|Mean
2528486|NCT03503578|Primary|Frequencies At Which Changes in Alpha, Theta, and Slow-Delta Wave Power Were Observed From Baseline During Sevoflurane-induced General Anesthesia|Changes in power from baseline at various EEG spectral frequencies were assessed at sevoflurane-induced loss of responsiveness. EEGs of 12 patients were analyzed to determine changes in various EEG spectral frequencies (alpha, theta, delta, etc.) from baseline. The outcome measure reflects the associated frequency (Hz) at which changes were found under sevoflurane-induced general anesthesia. These frequency values are a representation of the findings for all 12 participants.|Approximately 60 minutes||||Hz|||Number
2528487|NCT03503188|Secondary|Sub Study - The Percentage of Collected Auscultation Points|"For each participants the auscultation sound files were collected at 12 points of the body. In each defined region of the participant's body, auscultation was to be performed to maximize the sound quality according to the investigator's experience. Auscultations were recorded using a Littmann 3200 and the Ekuore One stethoscope. The unit of the measure is Percentage of auscultation points collected per participants."|Day 1 (Visit 1)|Substudy- All participants entered substudy set (ENSST): This included all participants for whom visit data were available and who took part in the substudy.|||PercentageOfAuscultationPointsCollected||Standard Deviation|Mean
2528488|NCT03503188|Secondary|Entire Study - Body Mass Index (BMI)|BMI is defined as the body weight divided by the square of the body height is presented for main and sub-study combined (entire study).|Day 1 (Visit 1)|ENT|||Kilogram/ meter^2 (kg/ m^2)||Standard Deviation|Mean
2528489|NCT03503188|Secondary|Entire Study - Smoking Status|Smoking status is presented as ex-smokers, currently smokers and never smoked participants for main and sub-study combined (entire study).|Day 1 (Visit 1)|ENT|||Participants|||Count of Participants
2528490|NCT03503188|Secondary|Entire Study - Participants Reported Symptoms of Respiratory Disease - Cough and Sputum|Number of participants that reported symptoms of respiratory disease (Cough and Sputum) for day time (DT) and night time (NT) is presented.|Day 1 (Visit 1)|ENT|||Participants|||Number
2528491|NCT03503188|Secondary|Entire Study - Participants Reported Symptoms of Respiratory Disease - Dyspnoea Recorded Via a Modified Medical Research Council (MRC) Scale|"Dyspnoea was assessed for participants as grade 0 and 1 of the modified MRC scale, ranging from 0 to 4 with `0´ being minor and `4´ being severe.~Where, 0 = I only get breathless with strenuous exercise;~= I get short of breath when hurrying on level ground or walking up a slight hill;~= On level ground, I walk slower than people of the same age because of breathlessness, or have to stop for breath when walking at my own pace;~= I stop for breath after walking about 100 meters or after a few minutes on level ground;~= I am too breathless to leave the house or I am breathless when dressing."|Day 1 (Visit 1)|All Patients Entered Set (ENT): ENT included all participants (Main Study and Sub Study) for whom visit data were available.|||Participants|||Number
2528492|NCT03503188|Primary|Main Study - The Percentage of Collected Auscultation Points|"For each participants the auscultation sound files were collected at 12 points of the body. In each defined region of the participant's body, auscultation was to be performed to maximize the sound quality according to the investigator's experience. Auscultations were recorded using a Littmann Digital Stethoscope (Model 3200) and the 3M Littmann StethAssist software on a computer provided for the study. The unit of the measure is Percentage of auscultation points collected per participants."|Day 1 (Visit 1)|Main study- All participants entered main study set (ENMST): This included all participants for whom visit data were available and who did not take part in the substudy.|||PercentageOfAuscultationPointsCollected||Standard Deviation|Mean
2528493|NCT03502915|Secondary|Mean Post-procedure Provider Assessed Level of Difficulty Score|Following the procedure, the obstetric provider performing the procedure will rate the ease of procedure on a 1-10 scale (1 being very easy and 10 being extremely difficult), ranging from 1 to 10. Higher scores indicate more difficulty, lower scores indicate less difficulty. A 10 point scale was used for this outcome, while an 11 point scale was used for the other 4 outcome measures (pain, anxiety, post-procedure pain and satisfaction).|Immediately Post-procedure, within approximately 15 minutes of final version attempt||||score on a scale||Standard Deviation|Mean
2528494|NCT03502915|Secondary|Mean Post-procedure Patient Satisfaction Score|Satisfaction will be assessed following the procedure using an 11 point scale (0 being not at all satisfied; 10 being extremely satisfied), ranging from 0 to 10. Higher scores indicate more satisfaction, lower scores indicate less satisfaction.|Immediately Post-procedure, within approximately 15 minutes of final version attempt||||score on a scale||Standard Deviation|Mean
2528495|NCT03502915|Secondary|Mean Post-procedure Pain Score|Pain scores will be collected following completion of the version using an 11 point scale (0 being no pain at all; 10 being worst pain imaginable), ranging from 0 to 10. Higher scores indicate more pain, lower scores indicate less pain.|Immediately Post-procedure, within approximately 15 minutes of final version attempt||||score on a scale||Standard Deviation|Mean
2528496|NCT03502915|Secondary|Mean Anxiety Score Experienced During Version|Anxiety scores will be collected following each version attempt using an 11 point scale (0 being not at all anxious; 10 being extremely anxious), ranging from 0 to 10. Higher scores indicate more anxiety, lower scores indicate less anxiety. If more than one attempt, anxiety scores will be averaged to obtain a single score for the entire procedure.|During each version procedure, a total average of up to approximately 30 minutes||||score on a scale||Standard Deviation|Mean
2528497|NCT03502915|Primary|Mean Pain Score Experienced During Version|Pain scores will be collected following each version attempt using an 11 point scale (with 0 being no pain at all; 10 being worst pain imaginable), ranging from 0 to 10. Higher scores indicate more pain, lower scores indicate less pain. If more than one attempt, pain scores will be averaged to obtain a single score for the entire procedure.|During each version procedure, a total average of up to approximately 30 minutes||||score on a scale||Standard Deviation|Mean
2528498|NCT03501277|Primary|AUC(0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Alogliptin and Pioglitazone||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The PK analysis set included all participants in the safety set who had sufficient plasma concentration data to facilitate the derivation of at least 1 PK parameter.|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Geometric Mean
2528499|NCT03501277|Primary|Cmax: Maximum Observed Plasma Concentration for Alogliptin and Pioglitazone||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The pharmacokinetic (PK) analysis set included all participants in the safety set who had sufficient plasma concentration data to facilitate the derivation of at least 1 PK parameter.|||nanogram per milliliter (ng/ml)||Standard Deviation|Geometric Mean
2528500|NCT03501264|Primary|Number of Participants With Changes in Help Seeking Scores|A measure of help-seeking intentions for emotional/mental distress from different sources of help. Options range from 1= never, 2=rarely, 3=occasionally, 4=a moderate amount, 5=a great deal. Total scale is out of 105 with higher scores indicating greater health seeking intentions. Questions were asked about: parents/guardians, relatives/family member, teacher, friend, mental health professional, nurse or doctor, and phone/chat line. Mean scores will be calculated at baseline and 1-month post intervention. These scores will then be compared to determine change over the intervention period.|Baseline and 1-month post intervention||||Participants|||Count of Participants
2528501|NCT03501043|Secondary|Passive Range of Motion (PROM) at Baseline and at Follow-up|Normal ranges of ankle dorsiflexion 0 to 30 degrees with knee flexed. Normal ranges of dorsiflexion 0 to 15 degrees with knee extended. Higher values in dorsiflexion range represent a better outcome.|Baseline, Follow-up (4-6 weeks)|Clinician moved the ankle at flexion or extension with no effort from the participant.|||degrees||Standard Deviation|Mean
2528502|NCT03501043|Secondary|Tardieu Scale (TS) at Baseline and at Follow-up|"Measurement of spastic response when passively ranging the ankle joint at very slow and very fast velocities with knee flexed and knee extended.~Quality of muscle reaction (scored 0-4). 0 is no resistance to passive ROM to 4 indicating joint is immobile."|Baseline, Follow-up (4-6 weeks)||||score on a scale||Inter-Quartile Range|Median
2528503|NCT03501043|Secondary|Modified Ashworth Scale (MAS) at Baseline and at Follow-up|"Passive range of ankle in 1 second with knee flexed and knee extended. Scale of 0-4 (0: no increase in muscle tone; 1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+:Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement); 2: More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3: Considerable increase in muscle tone passive, movement difficult; 4: Affected part(s) rigid in flexion or extension.~0-4 (Min-Max) Higher scores represents increase abnormal tone."|Baseline, Follow-up (4-6 weeks)||||score on a scale||Inter-Quartile Range|Median
2528504|NCT03501043|Primary|Step-length at Baseline and at Follow-up (Temporal-spatial Data)|"Step length measured as the distance between the heel contact point of one foot and that of the other foot.~Values are reported on the involved side. Larger values represent better outcome."|Baseline, Follow-up (4-6 weeks)||||meters||Standard Deviation|Mean
2528505|NCT03501043|Primary|Maximal Velocity|Baseline and follow-up MV with and without shoes. Distance covers over time when walking as fast as possible. Larger value is better.|Baseline, Follow-up (4-6 weeks)||||m/s||Standard Deviation|Mean
2528506|NCT03501043|Primary|Self-Selected Velocity (SSV)|Baseline and follow-up SSV with and without shoes. Distance covers over time at self selected pace. Larger value is better.|Baseline, Follow-up (4-6 weeks)||||m/s||Standard Deviation|Mean
2528507|NCT03500679|Secondary|Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Days 181 and 195|Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by OPKA at Days 181 and 195 were reported.|Days 181 and 195|Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.|||Percentage of participants||95% Confidence Interval|Number
2528508|NCT03500679|Secondary|OPKA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1|Specific functional antibacterial antibodies were measured by OPKA. GMR for serotypes O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1 were reported.|Day 181/Day 1 and Day 195/Day 1|Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.|||Ratio||95% Confidence Interval|Geometric Mean
2528509|NCT03500679|Secondary|OPKA GMTs for Serotypes O1A, O2, O6A and O25B at Days 181 and 195|Specific functional antibacterial antibodies were measured by OPKA. GMTs for serotypes O1A, O2, O6A and O25B at Days 181 and 195 were reported.|Days 181 and 195|Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.|||Titer||95% Confidence Interval|Geometric Mean
2528510|NCT03500679|Secondary|Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Days 181 and 195|Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by ELISA at Days 181 and 195 were reported.|Days 181 and 195|Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.|||Percentage of participants||95% Confidence Interval|Number
2528511|NCT03500679|Secondary|ELISA GMR for Serotype O1A, O2, O6A and O25B at Day 181/Day 1 and Day 195/Day 1|IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMR for serotypes O1A, O2, O6A and O25B (Day 181/Day 1 and Day 195/Day 1) was reported.|Day 181/Day 1 and Day 195/Day 1|Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.|||Ratio||95% Confidence Interval|Geometric Mean
2528512|NCT03500679|Secondary|ELISA GMTs for Serotypes O1A, O2, O6A, O25B at Days 181 and 195|IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A, O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Days 181 and 195 were reported.|Days 181 and 195|Analysis population included PPI analysis set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.|||Titer||95% Confidence Interval|Geometric Mean
2528725|NCT03491553|Secondary|Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48||Week 48|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2528513|NCT03500679|Secondary|Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (OPKA) at Day 15|Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by OPKA at Day 15 were reported.|Day 15|The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2528514|NCT03500679|Secondary|OPKA GMR for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1|Specific functional antibacterial antibodies were measured by OPKA. GMR for serotypes O1A, O2, O6A and O25B (Day 15/Day 1) was reported.|Day 15/Day 1|The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Ratio||95% Confidence Interval|Geometric Mean
2528515|NCT03500679|Secondary|Opsonophagocytic Killing Assay (OPKA) GMTs for Serotypes O1A, O2, O6A and O25B at Days 1 and 15|Specific functional antibacterial antibodies were measured by OPKA. GMTs for serotypes O1A, O2, O6A and O25B at Days 1 and 15 were reported.|Days 1 and 15|The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'n' (number analyzed) signifies number of participants evaluable for specified time points for specified categories.|||Titer||95% Confidence Interval|Geometric Mean
2528516|NCT03500679|Secondary|Number of Participants With Serious Adverse Events After Second Vaccination|An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.|Day 181 until Day 360|The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Here ‘N’ (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Participants|||Count of Participants
2528517|NCT03500679|Secondary|Percentage of Participants With Unsolicited Adverse Events After Second Vaccination|An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.|29 days after second vaccination (Day 181 to Day 210)|The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Here ‘N’ (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2528518|NCT03500679|Secondary|Percentage of Participants With Solicited Systemic Adverse Events After Second Vaccination|An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited systemic AEs were precisely defined systemic events that participants were specifically asked about and which were noted by participants in the diary. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.|14 days after second vaccination (Day 181 to Day 195)|The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Here ‘N’ (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2528519|NCT03500679|Secondary|Percentage of Participants With Solicited Local Adverse Events After Second Vaccination|An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited local AEs were precisely defined local events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration.|14 days after second vaccination (Day 181 to Day 195)|The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations. Here ‘N’ (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2528520|NCT03500679|Primary|Percentage of Participants With a 2-fold and 4-fold Increase From Baseline in Serum Antibody Titers (ELISA) at Day 15|Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by ELISA at Day 15 were reported.|Day 15|The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2528726|NCT03491553|Secondary|Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12||Week 12|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2528521|NCT03500679|Primary|ELISA Geometric Mean Ratio (GMR) for Serotypes O1A, O2, O6A and O25B at Day 15/Day 1|IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMR for serotypes O1A, O2, O6A and O25B (Day 15/Day 1) was reported.|Day 15/Day 1|The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Ratio||95% Confidence Interval|Geometric Mean
2528522|NCT03500679|Primary|ELISA GMTs for Serotypes O1A, O2, O6A and O25B at Day 15|IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Day 15 were reported.|Day 15|The PPI analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Titer||95% Confidence Interval|Geometric Mean
2528523|NCT03500679|Primary|Enzyme-linked Immunosorbent Assay (ELISA) Geometric Mean Titers (GMTs) for Serotypes O1A, O2, O6A and O25B at Day 1|Immunoglobulin G (IgG) antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Day 1 were reported.|Day 1|The per-protocol immunogenicity (PPI) analysis set consisted of all participants from the FAS excluding those with major protocol deviations expecting to impact the immunogenicity outcomes.|||Titer||95% Confidence Interval|Geometric Mean
2528524|NCT03500679|Primary|Number of Participants With Serious Adverse Events (SAEs) After First Vaccination|An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.|Up to Day 180|The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.|||Participants|||Count of Participants
2528525|NCT03500679|Primary|Percentage of Participants With Unsolicited Adverse Events After First Vaccination|An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.|29 days after first vaccination (Day 1 to Day 30)|The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
2528526|NCT03500679|Primary|Percentage of Participants With Solicited Systemic Adverse Events After First Vaccination|An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited systemic AEs were precisely defined systemic events that participants were specifically asked about and which were noted by participants in the diary. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.|14 days after first vaccination (Day 1 to Day 15)|The FAS included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
2528527|NCT03500679|Primary|Percentage of Participants With Solicited Local Adverse Events (AEs) After First Vaccination|An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited local AEs were precisely defined local events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration.|14 days after first vaccination (Day 1 to Day 15)|The full analysis set (FAS) included all randomized participants with at least one study vaccine administration documented regardless of the occurrence of protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
2528528|NCT03500406|Secondary|Participant Satisfaction Penile Length|Compare participant satisfaction scores including satisfaction with overall penile length|Baseline to 12 months post-operative|Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.||||||
2528529|NCT03500406|Secondary|Stretched Penile Length|Compare pre- and post-operative stretched penile lengths|From baseline to 12 months|Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.||||||
2528530|NCT03500406|Secondary|Operative Complications|Compare intra- and/or post-operative complication rates.|3, 6, 12 months post-operative|Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.||||||
2540735|NCT03042559|Secondary|Iliotibial Band Flexibility|To assess the flexibility of iliotibial band|Immediately following 1st session||||degree||Standard Deviation|Mean
2528531|NCT03500406|Secondary|Adverse Events With Use of Traction|Evaluate any adverse events with use of RestoreX® for penile lengthening.|From baseline to 3 months|Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.||||||
2528532|NCT03500406|Secondary|Participant Satisfaction With Traction|Compare patient reported satisfaction with use of traction device|From baseline to 3 months|Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.||||||
2528533|NCT03500406|Secondary|Participant Compliance|Compare Participant compliance with traction device|From baseline to 3 months|Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.||||||
2528534|NCT03500406|Primary|Length Assessment of Penile Prosthesis Implanted|The primary objective is to assess the length of the penile prosthesis inserted into subjects following completion of RestoreX® traction therapy compared to the control group (no treatment)|From baseline to 3 months|Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.||||||
2528535|NCT03500224|Secondary|Percentage of Participants With Adverse Events (AEs) Leading to Discontinuation of [14C]-TAK-954||Baseline up to Day 15|The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.|||percentage of participants|||Number
2528536|NCT03500224|Secondary|Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)||Baseline up to Day 31|The safety analysis set included all participants who were enrolled in the study and received at least 1 dose of study drug.|||percentage of participants|||Number
2528537|NCT03500224|Secondary|Ratio of AUC∞: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 to Total Radioactivity in Plasma TAK-954||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.|||ratio||Standard Deviation|Mean
2528538|NCT03500224|Secondary|Ratio of Total Radioactivity in Whole Blood to Plasma||Day 1 pre-dose and at multiple time points (up to 264 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available.|||ratio||Standard Deviation|Mean
2528539|NCT03500224|Primary|Fet Feces: Fraction of Radioactivity Excreted in Feces From Time 0 to Time t for [14C]-TAK-954||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.|||percentage of dose||Standard Deviation|Mean
2528540|NCT03500224|Primary|Fet Urine: Fraction of Total Radioactivity Excreted in Urine From Time 0 to Time t for [14C]-TAK-954||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.|||percentage of dose||Standard Deviation|Mean
2528541|NCT03500224|Primary|Fet Urine: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-954||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.|||percentage of dose||Standard Deviation|Mean
2528542|NCT03500224|Primary|Aet Feces: Amount of Total Radioactivity Excreted in Feces From Time 0 to Time t for [14C]-TAK-954||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.|||mcg eq||Standard Deviation|Mean
2528543|NCT03500224|Primary|Aet Urine: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-954||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.|||microgram (mcg)||Standard Deviation|Mean
2528544|NCT03500224|Primary|Aet Urine: Amount of Total Radioactivity Excreted in Urine From Time 0 to Time t for [14C]-TAK-954||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.|||microgram equivalent (mcg eq)||Standard Deviation|Mean
2528545|NCT03500224|Primary|Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-954||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.|||liter||Full Range|Geometric Mean
2528546|NCT03500224|Primary|Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for [14C]-TAK-954||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|No participant was analyzed since this outcome measure was not planned to be assessed but added in the protocol summary by error.||||||
2528547|NCT03500224|Primary|CL: Total Clearance of TAK-954 After Intravenous Administration of [14C]-TAK-954||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.|||L/h||Full Range|Geometric Mean
2528548|NCT03500224|Primary|CL: Total Clearance After Intravenous Administration for [14C]-TAK-954||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|No participant was analyzed since this outcome measure was not planned to be assessed but added in the protocol summary by error.||||||
2528727|NCT03491553|Secondary|Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8||Week 8|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2528549|NCT03500224|Primary|t1/2z: Terminal Disposition Phase Half-life in Plasma for TAK-954 and TAK-954 Metabolites||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set. PK data for metabolites could not be evaluated since metabolites were < lower limit of quantification and apparent terminal elimination portion of the concentration-time curve could not be characterized.|||hour||Full Range|Geometric Mean
2528550|NCT03500224|Primary|t1/2z: Terminal Disposition Phase Half-life of Radioactivity in Plasma and Whole Blood for [14C]-TAK-954||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.|||hour||Full Range|Geometric Mean
2528551|NCT03500224|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-954 and TAK-954 Metabolites||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. PK data for TAK-954 metabolite (THRX913682) could not be evaluated since metabolites were < lower limit of quantification.|||hour||Full Range|Geometric Mean
2528552|NCT03500224|Primary|Tmax: Time to Reach the Maximum Plasma and Whole Blood Radioactivity for [14C]-TAK-954||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.|||hour||Full Range|Median
2528553|NCT03500224|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 and TAK-954 Metabolites||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set. PK data for metabolites could not be evaluated since metabolites were < lower limit of quantification and apparent terminal elimination portion of the concentration-time curve could not be characterized.|||h*ng/mL||Full Range|Geometric Mean
2528554|NCT03500224|Primary|AUC∞: Area Under the Plasma and Whole Blood Radioactivity-time Curve From Time 0 to Infinity for [14C]-TAK-954||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.|||h*ng eq/mL||Full Range|Geometric Mean
2528555|NCT03500224|Primary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 and TAK-954 Metabolites||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. PK data for TAK-954 metabolite THRX913682 could not be evaluated since its plasma levels were < lower limit of quantification.|||hour*nanogram per milliliter (h*ng/mL)||Full Range|Geometric Mean
2528556|NCT03500224|Primary|AUClast: Area Under the Plasma and Whole Blood Radioactivity-time Curve From Time 0 to the Time of the Last Quantifiable Radioactivity for [14C]-TAK-954||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.|||h*ng eq/mL||Full Range|Geometric Mean
2528557|NCT03500224|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-954 and TAK-954 Metabolites||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. PK data for TAK-954 metabolite THRX913682 could not be evaluated since its plasma levels were less than (<) lower limit of quantification.|||nanogram per milliliter (ng/mL)||Full Range|Geometric Mean
2528558|NCT03500224|Primary|Cmax: Maximum Observed Plasma and Whole Blood Concentrations of Radioactivity for [14C]-TAK-954||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data.|||ng eq/mL||Full Range|Geometric Mean
2528559|NCT03500224|Primary|Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954||Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available.|||nanogram equivalent/milliliter(ng eq/mL)||Standard Deviation|Mean
2528560|NCT03500224|Primary|Cumulative Percentage of Dose Excreted in Feces for TAK-954|The cumulative percentage of dose excreted in feces as TAK-954 derived from 0-168 hour sampling was normalized for 100% recovery.|Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. Single sampling method used across participants, therefore there was no measure of dispersion.|||percentage of dose|||Number
2528561|NCT03500224|Primary|Cumulative Percentage of Dose Excreted in Urine for TAK-954||Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available.|||percentage of dose||Standard Deviation|Mean
2528562|NCT03500224|Primary|Mean Percent of Total Radioactivity in Plasma for TAK-954 and TAK-954 Metabolites||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. Data is reported for TAK-954. Data for metabolites are not reported because none exceeded greater than (>) 6% of the total plasma radioactivity.|||percentage of total radioactivity||Standard Deviation|Mean
2528607|NCT03496974|Secondary|Number of Patients Achieving 50% or Greater Reduction in SCORAD Score at Week 7|Calculated as per description in Outcome 8.|Group A: Week 4; Group B: Week 7|Number of participants analyzed = participants with SCORAD score assessment at specified time-points. Missing values imputed by LOCF.|||Participants|||Count of Participants
2528563|NCT03500224|Primary|Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Feces|Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.|Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|PK analysis set: All participants of safety set with sufficient data to facilitate at least 1 PK parameter from concentration time data. Single value is available for Metabolite (M) 16, M4, and M5 because they co-eluted under chromatographic conditions. Single sampling method used across participants, therefore there was no measure of dispersion.|||percentage of dose|||Number
2528564|NCT03500224|Primary|Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine|Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.|Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|PK analysis set: All participants of safety set with sufficient data to facilitate at least 1 PK parameter from concentration time data. Single value is available for Metabolite (M) 16, M4, and M5 because they co-eluted under chromatographic conditions. Single sampling method used across participants, therefore there was no measure of dispersion.|||Percentage of dose|||Number
2528565|NCT03500224|Primary|Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine and Feces Combined|Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.|Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|PK analysis set: All participants of safety set with sufficient data to facilitate at least 1 PK parameter from concentration time data. Single value is available for Metabolite (M) 16, M4, and M5 because they co-eluted under chromatographic conditions. Single sampling method used across participants, therefore there was no measure of dispersion.|||percentage of dose|||Number
2528566|NCT03500224|Primary|Cumulative Percentage of Radioactivity in Urine and Feces Combined||Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available.|||percentage of radioactive dose||Standard Deviation|Mean
2528567|NCT03500224|Primary|Cumulative Percentage of Administered Radioactivity Recovered in Feces||Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose|The PK analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available.|||percentage of radioactive dose||Standard Deviation|Mean
2528568|NCT03500224|Primary|Cumulative Percentage of Administered Radioactivity Recovered in Urine||Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose|The pharmacokinetic (PK) analysis set included all the participants of safety analysis set with sufficient concentration data to facilitate the derivation of at least 1 PK parameter from the concentration time data. The PK analysis set where data at specified time points was available.|||percentage of radioactive dose||Standard Deviation|Mean
2528569|NCT03500211|Secondary|5-days Postoperative Narcotic Use|To determine if narcotic use changes when patients use lidocaine patches by counting amount and frequency of narcotic use over admission. Average number of 5 mg oxycodone pills used in women who have undergone cesarean delivery assessed through questionnaire at 5 days postoperatively.|Postoperative (5 days)||||pills||Standard Deviation|Mean
2528570|NCT03500211|Primary|48-hour Postoperative Pain Scores|"To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 48 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0=no pain and 100=the worst pain you have ever felt."|Postoperative (48 hours)||||score on a scale||Standard Deviation|Mean
2528571|NCT03500211|Primary|36-hour Postoperative Pain Scores|"To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 36 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0=no pain and 100=the worst pain you have ever felt."|Postoperative (36 hours)||||score on a scale||Standard Deviation|Mean
2528572|NCT03500211|Primary|24-hour Postoperative Pain Scores|"To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 24 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0=no pain and 100=the worst pain you have ever felt."|Postoperative (24 hours)||||score on a scale||Standard Deviation|Mean
2528573|NCT03500211|Primary|12-hour Postoperative Pain Scores|"To determine if lidocaine patch is superior to placebo as an adjunctive therapy for acute postoperative pain. Average pain score in women who have undergone cesarean delivery at 12 hours postoperatively. Measured using a Visual Analog Scale (VAS), a scale which measures pain from 0 to 100 with 0=no pain and 100=the worst pain you have ever felt."|Postoperative (12 hours)||||score on a scale||Standard Deviation|Mean
2528574|NCT03500159|Secondary|Frequency and Severity of Adverse Events (AEs)||12 Weeks|||||||
2528575|NCT03500159|Secondary|Discontinuation of Study Medication Due to Treatment Failure||12 Weeks|||||||
2528576|NCT03500159|Secondary|Response to Treatment|Response to treatment as defined by a decrease in maximum daily pelvic pain (eDiary) at Week 12 with a decrease or no change to concomitant analgesic medication use.|12 Weeks|||||||
2528577|NCT03500159|Secondary|The Proportion of Subjects With ≥30% and ≥50% Improvement in NIH-CPSI Pain Subscale Compared to Placebo|Comparison between AQX-1125 200 mg and placebo in proportion of subjects with ≥30% and ≥50% improvement NIH-CPSI subscale at Week 6 and 12|12 Weeks|||||||
2528578|NCT03500159|Secondary|The Proportion of Subjects With ≥30% and ≥50% Improvement in Maximum Daily Pelvic Pain Compared to Placebo|Comparison between AQX-1125 200 mg and placebo in proportion of subjects with ≥30% and ≥50% improvement in maximum daily pelvic pain (mean) based on a standardized 11-point numeric rating scale (NRS) recorded by eDiary at Week 6 and 12|12 Weeks|||||||
2528579|NCT03500159|Secondary|Response to Treatment Compared to Placebo at Week 12 as Measured by the PGI-S|AQX-1125 200 mg compared to placebo as measured by the Patient's Global Impression of Severity Scale (PGI-S) at Week 12|12 Weeks|||||||
2528582|NCT03500159|Secondary|Time Course of Effects From Baseline Through to Week 16: AQX-1125 200 mg Compared to Placebo for Each of the Pain and Symptom Scale Endpoints|Change from Baseline at each clinic visit for AQX-1125 200 mg compared to placebo for; Mean of maximum daily pelvic pain score (eDiary), NIH-CPSI pain subscale and all domains total score, IIEF-EF, Mean of average daily pelvic pain scores (eDiary), average and maximum pelvic pain (Paper-based NRS in clinic), and 24-hour voiding frequency (eDiary)|16 Weeks|||||||
2528583|NCT03500159|Secondary|Change From Baseline to Week 12 in 24-hour Voiding Frequency (eDiary)|Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in voiding frequency as recorded by electronic diary (eDiary)|12 Weeks|||||||
2528584|NCT03500159|Secondary|Change From Baseline to Week 12 in Average and Maximum Pelvic Pain Scores in Clinic|Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in the average and maximum pelvic pain score based on a standardized 11-point numeric rating scale (NRS) recorded on paper-based questionnaire at clinic visits.|12 Weeks|||||||
2528585|NCT03500159|Secondary|Change From Baseline to Week 12 in Average Daily Pelvic Pain (eDiary),|Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in the average daily pelvic pain score based on a standardized 11-point numeric rating scale (NRS) recorded by electronic diary (eDiary)|12 Weeks|||||||
2528586|NCT03500159|Secondary|Change From Baseline to Week 12 in IIEF-EF|Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in Male sexual health as measured using the International Index of Erectile Function Questionnaire, Erectile Function Domain (IIEF-EF)|12 Weeks|||||||
2528587|NCT03500159|Secondary|Change From Baseline to Week 12 in NIH-CPSI|Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in NIH Chronic Prostatitis Symptom Index (NIH-CPSI) pain subscale and all domains total score|12 Weeks|||||||
2528588|NCT03500159|Primary|Change From Baseline to Week 12 in Maximum Daily Pelvic Pain (Mean)|Change from Baseline to Week 12 for AQX-1125 200 mg compared to placebo in the maximum daily pelvic pain score based on a standardized 11-point numeric rating scale (NRS) recorded by electronic diary (eDiary)|12 Weeks|Study was terminated prematurely, no analysis was performed||||||
2528589|NCT03498300|Secondary|Change From Baseline in Anti-pertussis Toxin Immunoglobulin G Levels Among Seropositive Participants Who Received Tdap to Those Who Received Td||Eight months||||IU/ml||Inter-Quartile Range|Median
2528590|NCT03498300|Primary|The Seroprevalence of Anti-pertussis Toxin Antibodies (Anti-PT IgG) in Pregnant Thai Women|"Percentage of participants who were seropositive for anti-pertussis toxin antibodies (anti-PT IgG).~The overall number of 129 participants is greater than the number of 42 participants include in the Particiant Flow Module because it was the sample size calculated based on the primary objective, which was the seroprevalence of anti-pertussis antibodies in pregnant Thai women. Randomized clinical trial on 42 seropositive participants was performed for one of the secondary objectives, which was to compare the different anti-PT IgG at delivery among seropositive participants who received Tdap to those who received Td."|Four months||||Participants|||Count of Participants
2528591|NCT03497039|Secondary|Ratio Between Diclofenac Concentration in Treated Knee Synovial Fluid and Plasma After 7 Days Topical Application of Study Treatment to the Knee (12 Hours After Last Administration of Study Treatment)|Synovial fluid was collected during surgery (participant's scheduled arthroplasty of the target knee on which study treatment was applied). Samples were analyzed for diclofenac levels using a validated bio analytical method in compliance with the applicable standard operating procedures of the bioanalytical laboratory. Diclofenac concentration values that were below the limit of quantification (LOQ) were replaced by 0 for placebo group. The ratio between diclofenac concentration in treated knee synovial fluid and plasma was calculated.|At Day 8 (up to a maximum of Day 15 in case of surgery delay)|Analyzable population consists of all participants who were randomized, received at least 1 dose of investigational product, completed surgery and had evaluable synovial tissue or synovial fluid sample. Here, number analyzed indicates participants with diclofenac plasma concentration and fluid concentration values greater than LOQ.|||(ng/mL)/(ng/mL)||95% Confidence Interval|Geometric Mean
2528592|NCT03497039|Secondary|Ratio Between Diclofenac Concentration in Treated Knee Synovial Tissue and Plasma After 7 Days Topical Application of Study Treatment to the Knee (12 Hours After Last Administration of Study Treatment)|Synovial tissue was collected during surgery (participant's scheduled arthroplasty of the target knee on which study treatment was applied). Samples were analyzed for diclofenac levels using a validated bio analytical method in compliance with the applicable standard operating procedures of the bioanalytical laboratory. Diclofenac concentration values that were below the LOQ were replaced by 0 for placebo group. The ratio between diclofenac concentration in treated knee synovial tissue and plasma was calculated.|At Day 8 (up to a maximum of Day 15 in case of surgery delay)|Analyzable population consists of all participants who were randomized, received at least 1 dose of investigational product, completed surgery and had evaluable synovial tissue or synovial fluid sample. Here, number analyzed indicates participants with diclofenac plasma concentration and tissue concentration values greater than LOQ.|||(ng/g)/(ng/mL)||95% Confidence Interval|Geometric Mean
2528593|NCT03497039|Primary|Diclofenac Concentration in Treated Knee Synovial Fluid After 7 Days Topical Application of Study Treatment to the Knee (12 Hours After Last Administration of Study Treatment)|Synovial fluid was collected during surgery (participant's scheduled arthroplasty of the target knee on which study treatment was applied). Samples were analyzed for diclofenac levels using a validated bio analytical method in compliance with the applicable standard operating procedures of the bioanalytical laboratory. Synovial fluid diclofenac concentration was summarized by treatment group. Number of participants with diclofenac concentration values that were below the LOQ were replaced by 0 for placebo group. The geometric mean was calculated with a two-sided 95% confidence interval assuming data on the logarithmic scale were normally distributed.|At Day 8 (up to a maximum of Day 15 in case of surgery delay)|Analyzable population consists of all participants who were randomized,received at least 1 dose of investigational product,completed surgery and had evaluable synovial tissue or synovial fluid sample.Here,number analyzed indicates participants with diclofenac fluid concentration values greater than LOQ.|||nanograms per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
2528718|NCT03491553|Secondary|Percentage of Participants With HBsAg Loss at Week 24|HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.|Week 24|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2528594|NCT03497039|Primary|Diclofenac Concentration in Treated Knee Synovial Tissue After 7 Days Topical Application of Study Treatment to the Knee (12 Hours After Last Administration of Study Treatment)|Synovial tissue was collected during surgery (participant's scheduled arthroplasty of the target knee on which study treatment was applied). Samples were analyzed for diclofenac levels using a validated bio analytical method in compliance with the applicable standard operating procedures of the bioanalytical laboratory. Synovial tissue diclofenac concentration was summarized by treatment group. Number of participants with diclofenac concentration values that were below the limit of quantification (LOQ) were replaced by 0 for placebo group. The geometric mean was calculated with a two-sided 95% confidence interval assuming data on the logarithmic scale were normally distributed.|At Day 8 (up to a maximum of Day 15 in case of surgery delay)|Analyzable population consists of all participants who were randomized, received at least 1 dose of investigational product, completed surgery and had evaluable synovial tissue or synovial fluid sample. Here, number analyzed indicates participants with diclofenac tissue concentration values greater than LOQ.|||nanograms per gram (ng/g)||95% Confidence Interval|Geometric Mean
2528595|NCT03496987|Secondary|Laterality of Effusion|Laterality of effusion (left or right)|<20 minutes||||Participants|||Count of Participants
2528596|NCT03496987|Secondary|Volume of Effusion|Volume of effusion drained (in mL)|<20 minutes|1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication).|||milliters||Standard Deviation|Mean
2528597|NCT03496987|Secondary|Etiology of Effusion|Clinical etiology of effusion|<7 days|1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication).|||Participants|||Count of Participants
2528598|NCT03496987|Secondary|Number of Patients Who Had a Complication as a Result of the Procedure|Any complications that occur as a direct result of the procedure. We tracked patients for 7 days after the procedure to capture any complications (which is typical clinical practice)|<7 days|1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication).|||Participants|||Count of Participants
2528599|NCT03496987|Secondary|Number of Patients Who Had an Early Termination of Procedure|Patients who had procedure termination prior to complete evacuation of the pleural contents (usually as a result of refractory pain or another symptom that the patient perceived).|5-20 minutes||||Participants|||Count of Participants
2528600|NCT03496987|Secondary|Time of Drainage|Actual time of drainage in seconds for each patient.|5-20 minutes|1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication).|||seconds||Standard Deviation|Mean
2528601|NCT03496987|Primary|Pain Change|"Difference in pain between pre-procedural pain and during drainage pain as measured as the difference between a pre-procedural NPSS pain score (range from 0 (no pain) to 10 (maximum pain)). This was asked again during drainage and the difference between the two was recorded. The values ranged from -10 to 10 (with a more negative number representing a decrease in pain and a more positive number representing an increase in pain)~The scale used is called The Numeric Pain Rating Scale. With ratings from 0-10. Zero is the least amount of pain experienced while 10 is the worst pain possible."|5-20 minutes|1 patient was excluded from analysis from the Vacuum Bottle Drainage arm from the original 51 enrolled because of a technical problem with the drainage system (not a complication).|||Pre-post NPRS Pain Scale Score||Standard Deviation|Mean
2528602|NCT03496974|Secondary|Change in HADS (Depression) Score From Baseline to Week 7|"The HADS is a set of fourteen questions to be rated by a patient on a four point (0-3) response category so the possible scores range from 0 to 21 for anxiety and 0 to 21 for depression. Scoring is as follows:~(0-7)= Normal (8-10)= Borderline Abnormal (11-21)= Abnormal"|Group A: Baseline to Week 4; Group B: Baseline to Week 7|Number of participants analyzed = participants with HADS score assessment at specified time-points. Missing values imputed by LOCF.|||score on a scale||95% Confidence Interval|Least Squares Mean
2528603|NCT03496974|Secondary|Change in HADS (Anxiety) Score From Baseline to Week 7|"The HADS is a set of fourteen questions to be rated by a patient on a four point (0-3) response category so the possible scores range from 0 to 21 for anxiety and 0 to 21 for depression. Scoring is as follows:~(0-7)= Normal (8-10)= Borderline Abnormal (11-21)= Abnormal"|Group A: Baseline to Week 4; Group B: Baseline to Week 7|Number of participants analyzed = participants with HADS score assessment at specified time-points. Missing values imputed by LOCF.|||score on a scale||95% Confidence Interval|Least Squares Mean
2528604|NCT03496974|Secondary|Change in Dermatology Life Quality Index (DLQI) From Baseline to Week 7|"The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on QOL. The format is a simple response (0 to 3 where 0 is not at all and 3 is very much) to 10 questions, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL."|Group A: Baseline to Week 4; Group B: Baseline to Week 7|Number of participants analyzed = participants with DLQI score assessment at specified time-points. Missing values imputed by LOCF.|||score on a scale||95% Confidence Interval|Least Squares Mean
2528605|NCT03496974|Secondary|Change in Global Individual Signs Score (GISS) From Baseline to Week 7|GISS assesses AD lesions for erythema, excoriations, lichenification and edema/papulation. Each component will be rated on a global basis (over the entire body surface rather than region) using a 4-point scale (0=none, 1=mild, 2=moderate and 3=severe) according to the EASI grading severity. Total score will range from 0 to 12 (no disease to most severe disease, respectively).|Group A: Baseline to Week 4; Group B: Baseline to Week 7|Number of participants analyzed = participants with GISS score assessment at specified time-points. Missing values imputed by LOCF.|||score on a scale||95% Confidence Interval|Least Squares Mean
2528606|NCT03496974|Secondary|Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 7.|POEM is a 7-item patient-reported quality of life outcome measure based on a questionnaire to determine disease symptoms, including bleeding, cracking, dryness, flaking, itching, sleep loss and weeping. The scoring range is from 0 to 28 (no disease to most severe disease, respectively).|Group A: Baseline to Week 4; Group B: Baseline to Week 7|Number of participants analyzed = participants with POEM score assessment at specified time-points. Missing values imputed by LOCF.|||score on a scale||95% Confidence Interval|Least Squares Mean
2528608|NCT03496974|Secondary|Number of Patients Achieving 50% or Greater Reduction in EASI Score at Week 7|EASI score will assess severity and extent of AD with respect to erythema, excoriation, infiltration and lichenification at 4 anatomic sites of the body: lower and upper extremities, trunk and head. The total EASI score shall be in a range of 0 to 72 points (from no disease to maximum disease severity, respectively).|Group A: Week 4; Group B: Week 7|Number of participants analyzed = participants with EASI score assessment at specified time-points. Missing values imputed by LOCF.|||Participants|||Count of Participants
2528609|NCT03496974|Secondary|Change in SCORing Atopic Dermatitis (SCORAD) Score From Baseline to Week 7|SCORAD was developed by the European Task Force on Atopic Dermatitis. (Severity scoring of Atopic Dermatitis: the SCORAD index), as a measure of disease severity in AD. It includes assessment of the eczema in addition to patient-reported symptoms. Total score ranges from 0 to 103 (no disease to most severe disease, respectively).|Group A: Baseline to Week 4; Group B: Baseline to Week 7|Number of participants analyzed = participants with SCORAD score assessment at specified time-points. Missing values imputed by LOCF.|||score on a scale||95% Confidence Interval|Least Squares Mean
2528610|NCT03496974|Secondary|Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (Worst Moment Itch) From Baseline to Week 7|"The NRS rating system captures the intensity of patient's itch, both maximum and average intensity over a 24-hour period. The following question was presented to patients: How would you rate your itch at the worst moment and on average during the previous 24 hours a scale of 0-10 (0=no itch and 10=worst possible itch)?"|Group A: Baseline to Week 4; Group B: Baseline to Week 7|Number of participants analyzed = participants with pruritus NRS score assessment at specified time-points. Missing values imputed by LOCF.|||score on a scale||95% Confidence Interval|Least Squares Mean
2528611|NCT03496974|Secondary|Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (Overall Itch) From Baseline to Week 7|"The NRS rating system captures the intensity of patient's itch, both maximum and average intensity over a 24-hour period. The following question was presented to patients: How would you rate your itch at the worst moment and on average during the previous 24 hours a scale of 0-10 (0=no itch and 10=worst possible itch)?"|Group A: Baseline to Week 4; Group B: Baseline to Week 7|Number of participants analyzed = participants with pruritus NRS score assessment at specified time-points. Missing values imputed by LOCF.|||score on a scale||95% Confidence Interval|Least Squares Mean
2528612|NCT03496974|Secondary|Number of Patients Achieving ≥2 IGA Score Reduction at Week 7|IGA assesses disease severity and clinical response using a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe. The score is determined by ranking the extent of erythema and papulation/infiltration. A clinical response to therapy will be an IGA score of 0 (clear) or 1 (almost clear).|Group A: Week 4; Group B: Week 7|Number of participants analyzed = participants with IGA score assessment at specified time-points. Missing values imputed by LOCF.|||Participants|||Count of Participants
2528613|NCT03496974|Secondary|Number of Patients Achieving Investigator's Global Assessment (IGA) Response (0 or 1) at Week 7|IGA assesses disease severity and clinical response using a 5-point scale: 0 = clear, 1= almost clear, 2 = mild, 3 = moderate, 4 = severe. The score is determined by ranking the extent of erythema and population/infiltration. A clinical response to therapy will be an IGA score of 0 (clear) or 1 (almost clear). Patients receiving more than one treatment with additional medication for AD exacerbation during the study or who are missing IGA scores at visit 8 (week 7) will be treated as non-responders. For the 200 mg group, IGA was recorded at visits 1,3, and 5; visit 5 is reported. For the 400 mg group, IGA was recorded at visits 1-8, visit 8 was reported.|Group A: Week 4; Group B: Week 7|All subjects who have received at least one dose of bermekimab were included in the analysis.|||Participants|||Count of Participants
2528614|NCT03496974|Secondary|Pharmacokinetics (PK) Assessment at Week 7|"An enzyme-linked immunosorbent assay (ELISA) has been developed to specifically measure bermekimab levels in human plasma. Blood will be drawn into a single 6 ml Na-Heparin collection tube at each PK collection time point. These samples will be collected per the study lab manual and immediately shipped to the Sponsor for PK analysis. The PK samples will also be used to test for the presence of antibodies against bermekimab.~PK sample collection time points are as follows:~Group A: Pre-dose at visits 1-5; visit 5 is reported Group B: Pre-dose at visit 1, visit 3, visit 5 and visit 8; visit 8 is reported"|Group A: Week 4; Group B: Week 7|Number of participants analyzed = participants with pk analysis data at specified time-point. Missing values were not included in this analysis.|||(μg/mL)||95% Confidence Interval|Mean
2528615|NCT03496974|Secondary|Change in Eczema Area and Severity Index (EASI) Score, From Baseline to Week 7 (or Last Visit)|"EASI score will assess severity and extent of AD with respect to erythema, excoriation, infiltration and lichenification at 4 anatomic sites of the body: lower and upper extremities, trunk and head. The total EASI score shall be in a range of 0 to 72 points (from no disease to maximum disease severity, respectively).~Group A: Change= (Baseline - Week 4 score); Group B: Change= (Baseline - Week 7 score)"|Group A: Baseline to Week 4; Group B: Baseline to Week 7|Number of participants analyzed = participants with EASI score assessment at specified time-points. Missing values imputed by last observation carried forward (LOCF).|||score on a scale||95% Confidence Interval|Least Squares Mean
2528616|NCT03496974|Primary|Number of Patients With Treatment Emergent Adverse Events (TEAEs)|Safety and tolerability endpoints were evaluated by monitoring all the adverse events from clinical and laboratory reporting, vital signs, physical examinations, ECG and urinalysis. All the Adverse Events that the subjects experienced from Visit 1 Day 1 (Post-injection) until 7 days after the last administration of the study drug were captured in the clinical database. AEs are coded using medical dictionary - MedDRA Version 21.0 and the severity was assigned using CTCAE version 4.03.|From Visit 1 (Post-injection) until 7 days after the last administration of the study drug.|All subjects who have received at least one dose of bermekimab were included in the safety analysis.|||Participants|||Count of Participants
2528617|NCT03496428|Secondary|Discrepancy (Trueness) Between STL Files in Teeth Adjacent to Implant|Linear measurements in µm between STL files in teeth adjacent to implant in several pre-defined locations|Both techniques will be used in the same appointment upon 3 months use of provisional crown|Patients in need of a definitive crown in a single implant in the esthetic anterior maxillar zone.|||Root mean square in μm||95% Confidence Interval|Mean
2528719|NCT03491553|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12|HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.|Week 12|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2528618|NCT03496428|Primary|Changes in Soft Tissues Around Implant|Discrepancies in soft tissues around implants between different techniques, conventional and digital, in a single unit implant impression, measured as root mean square in µm.|Both techniques will be used in the same appointment upon 3 months use of provisional crown|Patients with a single implant in the esthetic anterior maxillar zone in need of a definitive crown.|||root mean square in µm||95% Confidence Interval|Mean
2528619|NCT03496324|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs)|"Mild = Adverse event (AE) did not limit usual activities; subject may have experienced slight discomfort.~Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort.~Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain.~Unassessable/Unclassified = Insufficient information to be able to make an assessment Conditional/ Unclassified = Insufficient information to make an assessment at present Unrelated = No possibility that the AE was caused by the IMP Unlikely = Slight, but remote, chance that the AE was caused by the IMP, but the balance of judgment was that it was most likely not due to the investigational medicinal product (IMP).~Possible = Reasonable suspicion that the AE was caused by the IMP Probable = Most likely that the AE was caused by the IMP Certain = AE was definitely caused by the IMP"|Up to Day 7 (follow-up)|Safety population: All subjects who received at least 1 dose of IMP.|||Participants|||Count of Participants
2528620|NCT03496324|Secondary|Plasma Concentration Half-life (T1/2) of Ibuprofen||Pre-dose (Day -1), 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480 and 720 minutes (Day 0) post-dose|PK Parameter Summary set population. One Subject in Period 3 Reference (fasted) was not included in PK Parameter Summary Set as per statistical analysis plan (SAP) Population definitions.|||min||Standard Deviation|Mean
2528621|NCT03496324|Secondary|Time to Maximum Plasma Concentration (Tmax) of Ibuprofen||Pre-dose (Day -1), 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480 and 720 minutes (Day 0) post-dose|PK Parameter Summary set population. One Subject in Period 3 Reference (fasted) was not included in PK Parameter Summary Set as per statistical analysis plan (SAP) Population definitions.|||min||Standard Deviation|Mean
2528622|NCT03496324|Secondary|Ratio of AUC0-t/AUC0-inf (AUCR)||Pre-dose (Day -1), 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480 and 720 minutes (Day 0) post-dose|PK Parameter Summary set population. One Subject in Period 3 Reference (fasted) was not included in PK Parameter Summary Set as per statistical analysis plan (SAP) Population definitions.|||Ratio||Standard Deviation|Mean
2528623|NCT03496324|Secondary|Area Under Plasma Concentration-time Curve From Administration to Infinity (AUC0-inf) of Ibuprofen|AUC0-inf was calculated as AUC0-t + (Ct/Kel) where Ct was the last quantifiable concentration at time t.|Pre-dose (Day -1), 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480 and 720 minutes (Day 0) post-dose|PK Parameter Summary set population. One Subject in Period 3 Reference (fasted) was not included in PK Parameter Summary Set as per statistical analysis plan (SAP) Population definitions.|||min*μg/mL||Standard Deviation|Mean
2528624|NCT03496324|Secondary|Elimination Rate Constant (Kel) of Ibuprofen|Kel was calculated as the absolute value of the log-linear regression slope of the elimination phase (logged) over time (linear) using the post Cmax concentrations [at least 3 non-below the limit of quantification (BLQ)] that maximized the adjusted R2.|Pre-dose (Day -1), 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480 and 720 minutes (Day 0) post-dose|PK Parameter Summary set population. One Subject in Period 3 Reference (fasted) was not included in PK Parameter Summary Set as per statistical analysis plan (SAP) Population definitions.|||1/min||Standard Deviation|Mean
2528625|NCT03496324|Primary|Area Under Plasma Concentration-time Curve From Administration to the Last Quantifiable Concentration at Time t (AUC0-t) of Ibuprofen||Pre-dose (Day -1), 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480 and 720 minutes (Day 0) post-dose|PK Parameter Summary set population. One Subject in Period 3 Reference (fasted) was not included in PK Parameter Summary Set as per statistical analysis plan (SAP) Population definitions.|||min*μg/mL||Standard Deviation|Mean
2528626|NCT03496324|Primary|Maximum Plasma Concentration (Cmax) of Ibuprofen|One Subject in Period 3 Reference (fasted) was not included in PK Parameter Summary Set as per statistical analysis plan (SAP) Population definitions.|Pre-dose (Day -1), 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480 and 720 minutes (Day 0) post-dose|Pharmacokinetics (PK) Parameter Summary Set population: All subjects from the PK dataset with evaluable PK parameters for each treatment period. (PK Dataset: All subjects from the safety population with evaluable plasma concentrations).|||μg/ml||Standard Deviation|Mean
2528627|NCT03495856|Other Pre-specified|Trait Mindfulness Scores|Freiburg Mindfulness Inventory. Possible scores range from 14 to 52, with higher scores indicating greater mindfulness, a better outcome.|Baseline and 4 weeks (pre to post-intervention)|Participants who completed baseline and post assessments|||score on a scale||Standard Deviation|Mean
2528628|NCT03495856|Other Pre-specified|Chronic Pain Acceptance Scores|Chronic Pain Acceptance Questionnaire-Revised. Scores range from 0-120 with higher scores representing higher chronic pain acceptance, a better outcome.|Baseline and 4 weeks (pre to post-intervention)|Participants who completed baseline and post assessments|||score on a scale||Standard Deviation|Mean
2528629|NCT03495856|Other Pre-specified|Pain Catastrophizing Scale Scores|Pain Catastrophizing Scale. Scores range from 0-52, with higher scores indicating more pain catastrophizing, or worse outcome.|Baseline and 4 weeks (pre to post-intervention)|Participants who completed baseline and post assessments|||score on a scale||Standard Deviation|Mean
2528630|NCT03495856|Other Pre-specified|Positive Affect and Well-being Scores|Positive Affect and Well-being Scale - 9 items. This scale comes from the Neurological Quality of Life Measurement System (Neuro QOL). Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Higher scores indicate greater positive affect and well-being, a better outcome.|Baseline and 4 weeks (pre to post-intervention)|Participants who completed baseline and post assessments|||T-score||Standard Deviation|Mean
2528631|NCT03495856|Other Pre-specified|Perceived Stress Scale Scores|Perceived Stress Scale - 4 item version. Possible scores range from 0-16. Lower scores indicate lower perceived stress, a better outcome.|Baseline and 4 weeks (pre to post-intervention)|Participants who completed baseline and post assessments|||score on a scale||Standard Deviation|Mean
2528720|NCT03491553|Secondary|Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48||Baseline, Week 48|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2528632|NCT03495856|Secondary|Sleep Disturbance Short-Form 4a Scores|Sleep disturbance short-form 4a - Patient Reported Outcomes Measurement Information System. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Lower scores represent less sleep disturbance, a better outcome.|Baseline and 4 weeks (pre to post-intervention)|Participants who completed baseline and post-assessment|||T-score||Standard Deviation|Mean
2528633|NCT03495856|Secondary|Anxiety Short-Form 4a Scores|Anxiety short-form 4a - Patient Reported Outcomes Measurement Information System. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. Lower scores represent lower anxiety, a better outcome.|Baseline and 4 weeks (pre to post-intervention)|Participants who completed baseline and post assessments|||T-score||Standard Deviation|Mean
2528634|NCT03495856|Secondary|Depression Short-Form 4a Scores|Depression short-form 4a - Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A lower score indicates less depression, a better outcome.|Baseline and 4 weeks (pre to post-intervention)|Participants who completed baseline and post assessments|||T-score||Standard Deviation|Mean
2528635|NCT03495856|Secondary|Physical Functioning Scores|Physical functioning short-form 4a - Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A higher score indicates higher physical functioning, or a better outcome.|Baseline and 4 weeks (pre to post-intervention)|Participants who completed baseline and post assessments|||T-score||Standard Deviation|Mean
2528636|NCT03495856|Secondary|Pain Interference Scores|Pain Interference short-form 6b, Patient Reported Outcomes Measurement Information System scale. Raw scores were converted using the HealthMeasures scoring service to standardized T-Scores with M=50, SD=10 and ranging from 20 to 80. A lower score indicates lower pain interference, or a better outcome.|Baseline and 4 weeks (pre to post-intervention)|Participants who completed baseline and post assessments|||T-score||Standard Deviation|Mean
2528637|NCT03495856|Secondary|Pain Intensity Scores|Pain intensity rating: 1 item from the Patient Reported Outcomes Measurement Information System (PROMIS), with pain intensity rated on 0-10 scale with lower values indicating less pain, or better outcome.|Baseline and 4 weeks (pre to post-intervention)|Participants who completed baseline and post-assessments|||units on a scale||Standard Deviation|Mean
2528638|NCT03495856|Primary|Acceptability - Intervention Satisfaction|Question assessing participants satisfaction with the intervention|4 weeks (within one week post-intervention)|Participants who completed the post-assessment|||Participants|||Count of Participants
2528639|NCT03495856|Primary|Credibility and Expectancy Questionnaire Scores|Credibility and Expectancy Questionnaire. Each item is scored separately and rated on a scale from 1 [not at all] to 10 [very]. Scores for each item range from 1-10, with higher ratings indicating higher credibility and expectancy.|Intervention week 2|Participants who completed the measure after session 2 (week 2)|||units on a scale||Standard Deviation|Mean
2528640|NCT03495856|Primary|Feasibility - Session Attendance|Average sessions attended (proportion)|4 weeks (intervention weeks 1-4)||||Proportion of sessions||95% Confidence Interval|Mean
2528641|NCT03495856|Primary|Feasibility - Study Retention|Proportion of participants enrolled who completed the study|4 weeks|All participants who enrolled and completed the baseline assessment|||Proportion of participants||95% Confidence Interval|Mean
2528642|NCT03494985|Secondary|Area Under Curve (AUC) up to 4 Hours After Treatment- Response of All Question of the Modified Product Performance and Attributes Questionnaire I (PPAQ I)|The AUC was calculated for the interval starting at the time of the 30 minute response and ending at the time of the last valid reading using the trapezoidal method on Day 1 and Day 29. AUC was calculated for the score of the individual question of PPAQ1. All the questions were scored using the following scale: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent.|At Day 1 and 29|ITT (N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment.|||Scores on scale/seconds||Standard Deviation|Mean
2528643|NCT03494985|Secondary|Individual Questions Scores of Modified Product Performance and Attributes Questionnaire II (PPAQ II)|Participants were asked to use the following scale to rate questions of PPAQ II as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ II had following questions; Q1: Providing relief all night, Q2: Reducing the number of times you wake up from dry mouth, Q3: Feeling less parched when you wake up, Q4: Having a long lasting dry mouth relief, Q5. Having a long lasting lubricating effect, Q6: Having a long lasting moisturizing effect. PPAQ II was assessed before supervised product use on Day 8 and 29 of treatment.|At Day 8 and 29|ITT (N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment.|||Score on scale||Standard Deviation|Mean
2528644|NCT03494985|Secondary|Individual Scores for All Questions of Modified Product Performance and Attributes Questionnaire I (PPAQ I) at Day 8|Participants were asked to use the following scale to rate questions of PPAQ I as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQI had following questions Q1: Relieving the discomfort of dry mouth Q2: Feeling comfortable in the mouth, Q3: Soothing your mouth, Q4: Allowing you to speak without difficulty, Q5: Effectively moistens your mouth, Q6: Effectively lubricates your mouth, Q7: Helping to freshen your breath, Q8: Protecting your mouth from drying out, Q9: Providing whole mouth comfort, Q10: Helping you to swallow without difficulty, Q11: Helping mouth feel 'normal', Q12: Having a cooling sensation. PPAQ I was assessed at 2 hours after supervised product use on Day 8 of treatment.|At Day 8 (2 hours after supervised product use)|ITT (N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment.|||Score on scale||Standard Deviation|Mean
2528670|NCT03493386|Secondary|Part 1: Change From Baseline in ECG Parameter; PR Interval, QRS Interval, QT Interval, QT Duration Corrected for Heart Rate by Friderician Formula (QTcF) Interval|Single 12-lead ECG's were obtained from using an ECG machine that automatically calculated the heart rate and measured PR Interval, QRS Duration, Uncorrected QT interval and Corrected QT (Fridericia's correction) interval at given time point. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1), 3 and 24 hours (post-dose)|Safety Population.|||Milliseconds (msec)||Standard Deviation|Mean
2528645|NCT03494985|Secondary|Individual Scores of All Question From 2-12 of Modified Product Performance and Attributes Questionnaire I (PPAQ I)|Participants were asked to use the following scale to rate question (Q) 2 to 12 of PPAQ I as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ I had following questions Q2: Feeling comfortable in the mouth, Q3: Soothing your mouth, Q4: Allowing you to speak without difficulty, Q5: Effectively moistens your mouth, Q6: Effectively lubricates your mouth, Q7: Helping to freshen your breath, Q8: Protecting your mouth from drying out, Q9: Providing whole mouth comfort, Q10: Helping you to swallow without difficulty, Q11: Helping mouth feel 'normal', Q12: Having a cooling sensation. PPAQ I was assessed at 30 minutes, 1 hour, 2, and 4 hours after supervised product use on Day 1 and 29 of treatment. Individual score for each question at different tome point was reported for this endpoint.|At Day 1 and 29 (30 minutes, 1 hour, 2 and 4 hours after supervised product use)|ITT(N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment.|||Score on scale||Standard Deviation|Mean
2528646|NCT03494985|Secondary|Modified Product Performance and Attributes Questionnaire I (PPAQ I) Question Number 1: Relieving the Discomfort of Dry Mouth) Day 1|Participants were asked to use the following scale to rate question 1 (Relieving the discomfort of dry mouth) of PPAQ I as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ I was assessed at 30 minutes, 1 hour, 2, and 4 hours after supervised product use on Day 1 of treatment.|At Day 1 of treatment (30 minutes, 1 hour, 2 and 4 hours after supervised product use)|ITT (N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment.|||Score on scale||Standard Deviation|Mean
2528647|NCT03494985|Secondary|Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1:Relieving the Discomfort of Dry Mouth ) at Day 29|Participants were asked to use the following scale to rate question 1 (Relieving the discomfort of dry mouth) of PPAQ I as it applied to the study product:1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ I was assessed at 30 minutes, 1 hour, and 4 hours after supervised product use on Day 29 of treatment.|At Day 29 of treatment (30 minutes, 1 hour and 4 hours after supervised product use)|ITT (N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment.|||Score on scale||Standard Deviation|Mean
2528648|NCT03494985|Primary|Modified Product Performance and Attributes Questionnaire I (PPAQ I) (Question Number 1: Relieving the Discomfort of Dry Mouth)|Participants were asked to use the following scale to rate question 1 (Relieving the discomfort of dry mouth) of PPAQ I as it applied to the study product: 1= poor, 2= fair, 3= good, 4= very good, and 5= excellent. PPAQ I was assessed at 2 hours after supervised product use on Day 29 of treatment.|At Day 29 of treatment (2 hours after supervised product use)|Intent to treat (ITT, N= 396) population defined as all randomized participants with at least one post-baseline assessment of efficacy. The ITT population was analyzed as per randomized treatment. Number of participants analyzed for this endpoint were part of the IIT population, evaluated on Day 29.|||Score on scale||Standard Deviation|Mean
2528649|NCT03493828|Primary|Effect of Transversus Abdominis Plane (TAP) Block Using Either 0.5% or 0.25% Bupivacaine on Analgesia for Cesarean Section Patients When Compared to Placebo.|The total the number of Patient Controlled Analgesia (PCA) boluses used by the patients postoperatively within 24 hours|0-24 hours|Number of PCA bolus used within 24 hours|||PCA bolus||Standard Error|Mean
2528650|NCT03493386|Secondary|Part 2: Change From Baseline in ECG Parameter; PR Interval, QRS Interval, QT Interval, QTcF Interval|Single 12-lead ECG's were obtained from using an ECG machine that automatically calculated the heart rate and measured PR Interval, QRS Duration, Uncorrected QT interval and Corrected QT (Fridericia's correction) interval at given time point. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1),3 and 24hours (pre-dose)|Safety Population|||Milliseconds (msec)||Standard Deviation|Mean
2528651|NCT03493386|Secondary|Part 2: Change From Baseline in ECG Parameter; Mean Heart Rate (HR)|Single 12-lead ECG's were obtained from using an ECG machine that automatically calculated the heart rate and measured PR Interval, QRS Duration, Uncorrected QT interval and Corrected QT (Fridericia's correction) interval at given time point. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1),3 and 24hours (pre-dose)|Safety Population|||Beats/minute||Standard Deviation|Mean
2528652|NCT03493386|Secondary|Part 2: Change From Baseline in Temperature|Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1),3 and 24hours (pre-dose)|Safety Population|||celcius||Standard Deviation|Mean
2528653|NCT03493386|Secondary|Part 2: Change From Baseline in Pulse Rate|Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1),3 and 24hours (pre-dose)|Safety Population|||Beats per minute||Standard Deviation|Mean
2528654|NCT03493386|Secondary|Part 2: Change From Baseline in Vital Signs; Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|DBP and SBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time point. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1),3 and 24hours (pre-dose)|Safety Population|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2528655|NCT03493386|Secondary|Part 2: Change From Baseline in Urinalysis Parameter; Specific Gravity|Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up to 24 hours in Part 2. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24 hours (post-dose)|Safety Population|||Kilogram per cubic meter||Standard Deviation|Mean
2540736|NCT03042559|Secondary|Iliotibial Band Flexibility|To assess the flexibility of iliotibial band|baseline||||degree||Standard Deviation|Mean
2528656|NCT03493386|Secondary|Part 2: Change From Baseline in Urinalysis Parameter; Potential of Hydrogen (pH)|Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by method up to 24 hours in Part 2. Day-1 (one day before the Pre-Dose) was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24 hours (post-dose)|Safety Population|||pH||Standard Deviation|Mean
2528657|NCT03493386|Secondary|Part 2: Change From Baseline in Hematology Parameter Erythrocytes|Blood samples were collected to analyze hematology parameter; erythrocytes. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24 hours (post-dose)|Safety Population|||Trillion cells/liter (10^12 cell/L)||Standard Deviation|Mean
2528658|NCT03493386|Secondary|Part 2: Change From Baseline in Hematology Parameters Platelets, Leukocytes|Blood samples were collected to analyze hematology parameter; platelets, leukocytes. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24 hours (post-dose)|Safety Population|||Billion cells per liter (10^9/L)||Standard Deviation|Mean
2528659|NCT03493386|Secondary|Part 2: Change From Baseline in Hematology Parameter EMCV|Blood samples were collected to analyze hematology parameter; EMCV. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24 hours (post-dose)|Safety Population|||Femtoliters||Standard Deviation|Mean
2528660|NCT03493386|Secondary|Part 2: Change From Baseline in Hematology Parameter: EMCH|Blood samples were collected to analyze hematology parameter; EMCH. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24 hours (post-dose)|Safety Population|||picograms||Standard Deviation|Mean
2528661|NCT03493386|Secondary|Part 2: Change From Baseline in Hematology Parameters; Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils|Blood samples were collected to analyze hematology parameters; basophils, eosinophils, lymphocytes, monocytes, neutrophils. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24 hours (post-dose)|Safety Population|||Percentage of cells||Standard Deviation|Mean
2528662|NCT03493386|Secondary|Part 2: Change From Baseline in Hematology Parameters; Hb, Erythrocyte MCHC|Blood samples were collected to analyze hematology parameters; Hb, erythrocyte MCHC. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24 hours (post-dose)|Safety Population|||Grams per liter (g/L)||Standard Deviation|Mean
2528663|NCT03493386|Secondary|Part 2: Change From Baseline in Hematology Parameters; Reticulocytes|Blood samples were collected to analyze hematology parameter; reticulocytes. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24 hours (post-dose)|Safety Population|||Praportion of reticulocytes in blood||Standard Deviation|Mean
2528664|NCT03493386|Secondary|Part 2: Change From Baseline in Hematology Parameters; Hematocrit|Blood samples were collected to analyze hematology parameter; hematocrit. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24 hours (post-dose)|Safety Population|||Praportion of red blood cells in blood||Standard Deviation|Mean
2528665|NCT03493386|Secondary|Part 2: Change From Baseline in Chemistry Parameters; Direct Bilirubin, Bilirubin, Creatinine, Urate|Blood samples were collected to analyze the chemistry parameters; direct bilirubin, bilirubin, creatinine, urate. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24 hours (post-dose)|Safety Population|||Micromoles per liter (umol/L)||Standard Deviation|Mean
2528666|NCT03493386|Secondary|Part 2: Change From Baseline in Chemistry Parameters; Albumin, Protein|Blood samples were collected to analyze the chemistry parameters; albumin, protein. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24 hours (post-dose)|Safety Population|||Grams per liter (g/L)||Standard Deviation|Mean
2528667|NCT03493386|Secondary|Part 2: Change From Baseline in Chemistry Paremeters; ALP, ALT, AST, Creatine Kinase, Lactate Dehydrogenase, GGT|Blood samples were collected to analyze the chemistry parameters; ALP,ALT, AST, creatine kinase, lactate dehydrogenase and GGT. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24 hours (post-dose)|Safety Population|||International unit per liter (IU/L)||Standard Deviation|Mean
2528668|NCT03493386|Secondary|Part 2: Change From Baseline Chemistry Parameters; Glucose, Calcium, Cholesterol, Chloride, HDL Cholesterol, LDL Cholesterol, Potassium, Phosphate, Sodium, Triglycerides, and Urea|Blood samples were collected to analyze the chemistry parameters; glucose, calcium, cholesterol, chloride, HDL cholesterol, LDL cholesterol, potassium, phosphate,sodium, triglycerides, and urea. Day-1 (one day before the Pre-Dose) was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24 hours (post-dose)|Safety Population|||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
2528669|NCT03493386|Secondary|Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Safety population comprised of all randomized participants who took at least one dose of study treatment.|Up to Day 16|Safety Population|||Participants|||Number
2528700|NCT03493386|Primary|Part 1:Apparent Clearance (CL/F) of Daprodustat|Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2|Safety Population|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2528671|NCT03493386|Secondary|Part 1: Change From Baseline in Electrocardiogram (ECG) Parameter; Mean Heart Rate (HR)|Single 12-lead ECG's were obtained from using an ECG machine that automatically calculated the heart rate and measured PR Interval, QRS Duration, Uncorrected QT interval and Corrected QT (Fridericia's correction) interval at given time point. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1), 3 and 24 hours (post-dose)|Safety Population.|||Beats per minute||Standard Deviation|Mean
2528672|NCT03493386|Secondary|Part 1: Change From Baseline in Temperature|Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1), 3 and 24 hours (post-dose)|Safety Population.|||Celcius (c)||Standard Deviation|Mean
2528673|NCT03493386|Secondary|Part 1: Change From Baseline in Pulse Rate|Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1), 3 and 24 hours (post-dose)|Safety Population.|||Beats per minute||Standard Deviation|Mean
2528674|NCT03493386|Secondary|Part 1: Change From Baseline in Vital Signs; Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|DBP and SBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1), 3 and 24 hours (post-dose)|Safety Population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2528675|NCT03493386|Secondary|Part 1: Change From Baseline in Urinalysis Parameter; Specific Gravity|Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up to 24 hours in Part 1. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24hours post-dose|Safety Population.|||Kilogram per cubic meter||Standard Deviation|Mean
2528676|NCT03493386|Secondary|Part 1: Change From Baseline in Urinalysis Parameter; Potential of Hydrogen (pH)|Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by method up to 24 hours in Part 1.Day-1 (one day before the Pre-Dose) was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24hours post-dose|Safety Population.|||pH||Standard Deviation|Mean
2528677|NCT03493386|Secondary|Part 1: Change From Baseline in Hematology Parameter: Erythrocytes|Blood samples were collected to analyze hematology parameter; erythrocytes. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24hours post-dose|Safety Population.|||Trillion cells/liter (10^12 cell/L)||Standard Deviation|Mean
2528678|NCT03493386|Secondary|Part 1: Change From Baseline in Hematology Parameters Platelets, Leukocytes|Blood samples were collected to analyze hematology parameter; platelets, leukocytes. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24hours post-dose|Safety Population.|||Billion cells per liter (10^9/L)||Standard Deviation|Mean
2528679|NCT03493386|Secondary|Part 1: Change From Baseline in Hematology Parameter Erythrocyte Mean Corpuscular Volume (EMCV)|Blood samples were collected to analyze hematology parameter; EMCV. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24hours post-dose|Safety Population.|||Femtoliters||Standard Deviation|Mean
2528680|NCT03493386|Secondary|Part 1: Change From Baseline in Hematology Parameter Erythrocyte MCHC|Blood samples were collected to analyze hematology parameter; EMCH. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24hours post-dose|Safety Population.|||Picograms (pg)||Standard Deviation|Mean
2528681|NCT03493386|Secondary|Part 1: Change From Baseline in Hematology Parameters; Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils|Blood samples were collected to analyze hematology parameters; basophils, eosinophils, lymphocytes, monocytes, neutrophil. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24hours post-dose|Safety Population.|||Percentage of cells||Standard Deviation|Mean
2528682|NCT03493386|Secondary|Part 1: Change From Baseline in Hematology Parameters; Hemoglobin (Hb), Erythrocyte Mean Corpuscular Hb Concentration (MCHC)|Blood samples were collected to analyze hematology parameters; Hb, EMCH concentration. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24hours post-dose|Safety Population.|||Grams per Liter (g/L)||Standard Deviation|Mean
2528683|NCT03493386|Secondary|Part 1:Change From Baseline in Hematology Parameter; Reticulocytes|Blood samples were collected to analyze hematology parameters; reticulocytes. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24hours post-dose|Safety Population.|||Praportion of reticulocytes in blood||Standard Deviation|Mean
2528684|NCT03493386|Secondary|Part 1:Change From Baseline in Hematology Parameter; Hematocrit|Blood samples were collected to analyze hematology parameters; hematocrit, reticulocytes. Platelets. Day-1 (one day before the Pre-Dose) was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24hours post-dose|Safety Population.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2528717|NCT03491553|Secondary|Percentage of Participants With HBsAg Loss at Week 48|HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.|Week 48|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2528685|NCT03493386|Secondary|Part 1: Change From Baseline in Chemistry Parameters; Direct Bilirubin, Bilirubin, Creatinine, Urate|Blood samples were collected to analyze the chemistry parameters; direct bilirubin, bilirubin, creatinine, urate. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24hours post-dose|Safety Population.|||Micromoles per liter (umol/L)||Standard Deviation|Mean
2528686|NCT03493386|Secondary|Part 1: Change From Baseline in Chemistry Parameters; Albumin, Protein.|Blood samples were collected to analyze the chemistry parameters; albumin, protein. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24hours post-dose|Safety Population.|||Grams per liter (g/L)||Standard Deviation|Mean
2528687|NCT03493386|Secondary|Part 1: Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Lactate Dehydrogenase and Gamma Glutamyl Transferase (GGT).|Blood samples were collected to analyze the chemistry parameters; ALP, ALT, AST, creatine kinase, lactate dehydrogenase and GGT. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24hours post-dose|Safety Population.|||International unit per liter (IU/L)||Standard Deviation|Mean
2528688|NCT03493386|Secondary|Part 1: Change From Baseline Chemistry Paramters: Glucose, Calcium, Cholesterol, Chloride, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Potassium, Phosphate, Sodium, Triglycerides, and Urea.|Blood samples were collected to analyze the chemistry parameters; glucose, calcium, cholesterol, chloride, HDL cholesterol, LDL cholesterol, potassium, phosphate, sodium, triglycerides, and urea. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the Post-Dose visit value.|Baseline (Day -1), 24hours post-dose|Safety Population.|||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
2528689|NCT03493386|Secondary|Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Safety population comprised of all randomized participants who took at least one dose of study treatment.|Up to Day 16|Safety Population|||Participants|||Count of Participants
2528690|NCT03493386|Primary|Part 2: Kel of Daprodustat|Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2|PK Population.|||Per hour||Geometric Coefficient of Variation|Geometric Mean
2528691|NCT03493386|Primary|Part 2: Vz/F of Daprodustat|Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2|PK Population.|||Milliliters (mL)||Geometric Coefficient of Variation|Geometric Mean
2528692|NCT03493386|Primary|Part 2: CL/F of Daprodustat|Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2|PK Population.|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2528693|NCT03493386|Primary|Part 2: Percentage AUCex of Dapordustat|Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2|PK Population.|||Percentage of AUCex||Geometric Coefficient of Variation|Geometric Mean
2528694|NCT03493386|Primary|Part 2: Tmax of Daprodustat|Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2|PK Population.|||hour||Full Range|Median
2528695|NCT03493386|Primary|Part 2: T1/2 and MRT of Daprodustat|Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12hours post-dose on Day 1, 24hours post-dose on Day 2|PK Population|||hour||Geometric Coefficient of Variation|Geometric Mean
2528696|NCT03493386|Primary|Part 2: Cmax of Daprodustat|Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12hours post-dose on Day 1, 24hours post-dose on Day 2|PK Population|||Nanogram/milliliter (ng/L)||Geometric Coefficient of Variation|Geometric Mean
2528697|NCT03493386|Primary|Part 2:AUC[0-t] andAUC [0-inf] of Daprodustat|Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12hours post-dose on Day 1, 24hours post-dose on Day 2|PK Population|||Hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2528698|NCT03493386|Primary|Part 1: Elimination Rate Constant (Kel) of Daprodustat|Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12hours post-dose on Day 1, 24hours post-dose on Day 2|Safety Population|||Per hour||Geometric Coefficient of Variation|Geometric Mean
2528699|NCT03493386|Primary|Part 1:Apparent Oral Volume of Distribution (Vz/F) of Daprodustat|Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2|Safety Population|||Milliliters (mL)||Geometric Coefficient of Variation|Geometric Mean
2540839|NCT03040011|Secondary|POD 1 Ibuprofen Consumption|The total amount of ibuprofen medication used on postoperative day 1.|Postoperative day 1||||milligrams||Inter-Quartile Range|Median
2528701|NCT03493386|Primary|Part 1: Percentage of AUC (0-inf) Obtained by Extrapolation (Percentage AUCex)|Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2|PK Population|||Percentage of AUCex||Geometric Coefficient of Variation|Geometric Mean
2528702|NCT03493386|Primary|Part 1: Time of Occurrence of Cmax (Tmax) of Daprodustat|Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2|PK Population|||hour||Full Range|Median
2528703|NCT03493386|Primary|Part 1:Terminal Phase Half-life (T1/2) of Daprodustat and Mean Residence Time (MRT)|Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2|PK Population|||hour||Geometric Coefficient of Variation|Geometric Mean
2528704|NCT03493386|Primary|Part 1:Maximum Observed Drug Concentration (Cmax) of Daprodustat|Blood samples were collected at indicated timepoints and pharmacokinetic (PK) analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2|PK Population|||Nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2528705|NCT03493386|Primary|Part 1:Area Under Plasma Concentration-time Curve (AUC) From Zero Hours to Last Measurable Concentration (AUC[0-t]) and AUC From Zero Hours Extrapolated to Infinity AUC [0-inf] of Daprodustat|Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin version 6.3. PK population comprised of all participants in the Safety population (all randomized participants) who received at least one dose of study intervention) who had at least 1 non-missing PK assessment.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours post-dose on Day 1, 24 hours post-dose on Day 2|PK Population|||Hour*nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2528706|NCT03492554|Secondary|Ease of Use|Average ease of use on a 1 (Unable to Use) to 5 (Easiest to Use) scale|1 Day||||Participants|||Count of Participants
2528707|NCT03492554|Secondary|Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference|Difference in R-wave amplitudes between the software and gold standard reference|1 Day|Waveform Assessment Analysis Set: Paired Software and Reference strips collected from subjects were randomly selected. If 6 consecutive paired beats for analysis cannot be found in these strips, they were excluded from further analysis. This analysis set was used for assessing the quality of the clinical waveform.|||Participants|||Count of Participants
2528708|NCT03492554|Secondary|Number of Participants With Software's Ability to Produce a Clinically Equivalent Waveform in Agreement to a Gold Standard Lead 1 Reference|Number of ECGs that pass a visual overlay|1 Day|Waveform Assessment Analysis Set: Paired Software and Reference strips collected from subjects were randomly selected. If 6 consecutive paired beats for analysis cannot be found in these strips, they were excluded from further analysis. This analysis set was used for assessing the quality of the clinical waveform.|||Participants|||Count of Participants
2528709|NCT03492554|Primary|Number of Participants With Software's Rhythm Classification of AF in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG|Sensitivity of rhythm classification|1 Day|Classifiable Analysis Set: All subjects who had readable/classifiable paired Software and Reference strips were used. This analysis set was used for analyzing the primary endpoints of sensitivity and specificity.|||Participants|||Count of Participants
2528710|NCT03492554|Primary|Number of Participants With Software's Rhythm Classification of SR in Agreement to a Physician's Interpretation of a Gold Standard 12-lead ECG|Specificity of rhythm classification|1 Day|Classifiable Analysis Set: All subjects who had readable/classifiable paired Software and Reference strips were used. This analysis set was used for analyzing the primary endpoints of sensitivity and specificity.|||Participants|||Count of Participants
2528711|NCT03491891|Primary|Very Late Stent Thrombosis|very late stent thrombosis demonstrated by coronary angiography|Five years||||Participants|||Count of Participants
2528712|NCT03491553|Secondary|Percentage of Participants With Drug Resistance Mutations|The criteria for a drug resistance mutation was having two consecutive visits of HBV DNA ≥ 69 IU/mL.|Baseline up to Week 48|There were no participants analyzed for the outcome measure since none of the participants met the criteria.||||||
2528713|NCT03491553|Secondary|Percentage of Participants With Virologic Breakthrough|Virologic breakthrough was defined as having two consecutive visits of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 69 IU/mL.|Baseline up to Week 48|There were no participants analyzed for the outcome measure since none of the participants met the criteria.||||||
2528714|NCT03491553|Secondary|Percentage of Participants With HBeAg Loss and Seroconversion at Week 48|HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as hepatitis B e antibody (HBeAb) test changing from negative or missing at baseline to positive at a postbaseline visit.|Week 48|Participants in the Full Analysis Set were analyzed. Analysis was performed only on HBeAg-positive CHB participants.|||percentage of participants|||Number
2528715|NCT03491553|Secondary|Percentage of Participants With HBeAg Loss and Seroconversion at Week 24|HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.|Week 24|Participants in the Full Analysis Set were analyzed. Analysis was performed only on HBeAg-positive CHB participants.|||percentage of participants|||Number
2528716|NCT03491553|Secondary|Percentage of Participants With HBeAg Loss and Seroconversion at Week 12|HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.|Week 12|Participants in the Full Analysis Set were analyzed. Analysis was performed only on HBeAg-positive CHB participants.|||percentage of participants|||Number
2547893|NCT02896595|Secondary|Anesthetic Requirements|average amount of intravenous anesthetics|Up to 270 minutes|Data not collected for this variable||||||
2528728|NCT03491553|Secondary|Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4||Week 4|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2528729|NCT03491553|Primary|Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24||Week 24|The Full Analysis Set included all randomized participants who took at least 1 dose of the study drug.|||percentage of participants||95% Confidence Interval|Number
2528730|NCT03491228|Secondary|Clinical Response Rates by Target Diseases|"Clinical response of ANAEMETRO Intravenous infusion was evaluated comprehensively at the completion of the observation period, being assessed as effective, not effective, or indeterminate by the physician based on clinical symptoms.~Clinical response rate, which was defined as the percentage of participants evaluated as effective over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.~Participants assessed as effective by the following target diseases were counted to assess whether they contribute to the clinical response: anaerobic infection, infectious enterocolitis, amebic dysentery, and the infection with both infectious enterocolitis and amebic dysentery."|Maximum 8 weeks|The clinical efficacy analysis set comprised of participants from the safety analysis set, excluding those with no information of clinical response or infections other than target disease. Participants evaluated as “indeterminate (IND)” were excluded from the calculation.|||Percentage of Participants||95% Confidence Interval|Number
2528731|NCT03491228|Secondary|Clinical Response Rate|"Clinical response of ANAEMETRO Intravenous infusion was evaluated comprehensively at the completion of the observation period, being assessed as effective, not effective, or indeterminate by the physician based on clinical symptoms.~Clinical response rate, which was defined as the percentage of participants evaluated as effective over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI."|Maximum 8 weeks|The clinical efficacy analysis set comprised of participants from the safety analysis set, excluding those with no information of clinical response or infections other than target disease. Participants evaluated as “indeterminate (n=12)” were excluded from the calculation.|||Percentage of Participants||95% Confidence Interval|Number
2528732|NCT03491228|Primary|Number of Participants With Adverse Drug Reaction (ADR)|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to ANAEMETRO Intravenous infusion in a participant who received ANAEMETRO Intravenous infusion. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to ANAEMETRO Intravenous infusion was assessed by the physician.|Maximum 8 weeks|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received ANAEMETRO Intravenous infusion at least once.|||Participants|||Number
2528733|NCT03490916|Secondary|Time to Completion of Ultrasound Exams|Time it takes to complete ultrasound exams|1 month|Participants enrolled but not randomized and did not receive study drug.||||||
2528734|NCT03490916|Primary|Pulmonary Edema Before and After Taking Acetazolamide|Edema measured through ultrasound exam|1 month|No participants were randomized and no participants received intervention.||||||
2528735|NCT03490110|Secondary|Network Modularity From EEG|EEG will be collected during a focused rest condition. Network modularity will be estimated from a matrix of connections between electrodes based on phase coherence, a unit-less measure of correlation between phase angles of EEG signals in the theta (4-8 Hz) frequency range. The modularity metric reflects the strength of modular network organization by summing the difference between the fraction of within-module connections to the total fraction of connections across modules, thus ranging from 0 (random) to 1 (completely modular). Change in network modularity will be analyzed for this data as change from before to after the intervention period.|Week 8, after the intervention period||||units on a scale||Standard Deviation|Mean
2528736|NCT03490110|Secondary|Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV)|Electroencephalography (EEG) will be collected during tasks that require attention and working memory. The old/new ERP effect (difference between brain responses to correctly remembered studied items vs. correctly rejected unstudied items) will be analyzed for this data prior to the intervention period.|Week 1, before the intervention period||||uV||Standard Deviation|Mean
2528737|NCT03490110|Secondary|Change in Event-Related Potential (ERP) Related to Memory Retrieval (Measured in uV)|Electroencephalography (EEG) will be collected during tasks that require attention and working memory. The old/new ERP effect (difference between brain responses to correctly remembered studied items vs. correctly rejected unstudied items) will be analyzed for this data as change from before to after the intervention period.|Week 8, after the intervention period||||uV||Standard Deviation|Mean
2528738|NCT03490110|Primary|Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery|"The investigators created a composite score based upon standardized performance on the following neurocognitive measures of attention and executive functions: Wechsler Adult Intelligence Test - 4th Edition- letter number sequence; Auditory Consonant Trigrams - 9, 18, 36 second conditions; Digit Vigilance Test - Total Errors; Delis-Kaplan Executive Function System Color-Word Interference Trials 3 and 4 - Time and Total Errors; & Trails B - Time. Performance on each measure was scored using populations norms, and these scores are then standardized (Z-scored) and averaged to create a composite outcome (the unit measure being Z-score).~A Z-score reflects the number of standard deviations a given score is away from the population mean: A Z-score of 0 is equal to the population mean, with positive and negative values reflecting performances above and below the population mean, respectively.~Change will be analyzed for this data as change from before to after the intervention period."|Week 8, after the intervention period||||units on a scale||Standard Deviation|Mean
2528760|NCT03487588|Secondary|Effectiveness of Treatment|Effectiveness of treatment as measured by the Physician Lesion Assessment scale. The Physician Lesion Assessment Scale (PLA) is a 4 point scale used by the investigator to assess each subjects SK lesion. PLA=0 (Clear);PLA=1 (Near Clear; not elevated); PLA=2 (Thin;thickness </= 1 mm); PLA=3 (Thick; thickness > 1 mm).|Day 113||||score on a scale (PLA)||Standard Deviation|Mean
2528761|NCT03487588|Primary|Subject Satisfaction|Subject Satisfaction Questionnaire after treatment with A-101 Topical Solution|Day 113||||Participants|||Count of Participants
2528739|NCT03490110|Primary|Composite Score of Attention and Executive Functioning From a Neurocognitive Test Battery|"The investigators created a composite score based upon standardized performance on the following neurocognitive measures of attention and executive functions: Wechsler Adult Intelligence Test - 4th Edition- letter number sequence; Auditory Consonant Trigrams - 9, 18, 36 second conditions; Digit Vigilance Test - Total Errors; Delis-Kaplan Executive Function System Color-Word Interference Trials 3 and 4 - Time and Total Errors; & Trails B - Time. Performance on each measure was scored using populations norms, and these scores are then standardized (Z-scored) and averaged to create a composite outcome (the unit measure being Z-score).~A Z-score reflects the number of standard deviations a given score is away from the population mean: A Z-score of 0 is equal to the population mean, with positive and negative values reflecting performances above and below the population mean, respectively."|Week 1, before intervention period (baseline)||||units on a scale||Standard Deviation|Mean
2528740|NCT03489720|Primary|The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Personal Accomplishment (PA) MBI-HSS Scores Broken Down by Level of Residency Training Completed.|"The degree of burnout among VUMC anesthesia interns and residents as quantified by baseline Personal Accomplishment MBI-HSS scores broken down by level of residency training completed.~MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS PA score includes 8 items to evaluate Personal Accomplishment (PA) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS PA total score ranges from 0 to 48 points. We consider a high degree of burnout in the case of PA≥ 39 points. Moderate burnout will be considered in the case of 32-38 DP points. Low levels will be considered for DP ≤31 points."|Baseline||||units on a scale||Standard Deviation|Mean
2528741|NCT03489720|Primary|The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Depersonalization MBI-HSS Scores Broken Down by Level of Residency Training Completed.|"The degree of burnout among VUMC anesthesia interns and residents as quantified by baseline Depersonalization MBI-HSS scores broken down by level of residency training completed.~MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS DP score includes 5 items to evaluate depersonalization (DP) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS DP total score ranges from 0 to 30 points. We consider a high degree of burnout in the case of DP≥ 13 points. Moderate burnout will be considered in the case of 7-12 DP points. Low levels will be considered for DP ≤6 points."|Baseline||||units on a scale||Standard Deviation|Mean
2528742|NCT03489720|Primary|The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Emotional Exhaustion (EE) MBI-HSS Scores Broken Down by Level of Residency Training Completed.|"The degree of burnout among VUMC anesthesia interns and residents as quantified by baseline Emotional Exhaustion MBI-HSS scores broken down by level of residency training completed.~MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS EE score includes 9 items to evaluate emotional exhaustion (EE), with scores ranging from 0 to 6 on the Likert scale. MBI-HSS EE total score ranges from 0 to 54 points. We consider a high degree of burnout in the case of EE ≥ 27 points. Moderate burnout will be considered in the case of 26<EE<19 points. Low levels will be considered for EE≤18 points."|Baseline||||units on a scale||Standard Deviation|Mean
2528743|NCT03489720|Primary|The Change in the Personal Accomplishment (PA) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase Stratified by Training Level.|"The change in the PA burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase stratified by training level.~MBI-HSS is a survey to measure burnout in professionals in human services. PA MBI-HSS includes 8 items to evaluate personal accomplishment (PA), with scores ranging from 0 to 6 on the Likert scale. MBI-HSS PA total score ranges from 0 to 48 points. We consider a high degree of burnout in the case of PA≥ 39 points. Moderate burnout will be considered in the case of 32-38 PA points. Low levels will be considered for PA ≤31 points."|Baseline to 8 weeks|There were 16 PGY1, 13 PGY2, and 15 PGY3 participants in study. Data available in 15 PGY1 participants for change in exercise intervention period and baseline in usual exercise period, and change in 13 participants after usual exercise program.|||units on a scale||Standard Deviation|Mean
2528744|NCT03489720|Primary|The Change in the Depersonalization (DP) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase Stratified by Training Level.|"The change in the Depersonalization (DP) burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase stratified by training level.~MBI-HSS is a survey to measure burnout in professionals in human services. DP MBI-HSS includes 5 items to evaluate depersonalization (DP) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS DP total score ranges from 0 to 30 points. We consider a high degree of burnout in the case of DP ≥ 10. Moderate burnout will be considered in the case of 6<DP<9 points. Low levels will be considered for DP≤5 points."|Baseline to 8 weeks|There were 16 PGY1, 13 PGY2, and 15 PGY3 participants in study. Data available in 15 PGY1 participants in exercise intervention period.|||units on a scale||Standard Deviation|Mean
2528745|NCT03489720|Primary|Change in the Emotional Exhaustion (EE) Burnout Score(as Measured by MBI From Baseline to End of Each Exercise Phase Stratified by Training Level (Post Graduate Year 1 (PGY1), Post Graduate Year 2 (PGY2), and Post Graduate Year 3 (PGY3))|"The change in the Emotional Exhaustion burnout score(as measured by the Maslach Burnout Inventory (MBI)from baseline to end of each exercise phase stratified by training level.~MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS includes 9 items to evaluate emotional exhaustion (EE) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS EE total score ranges from 0 to 54 points. We consider a high degree of burnout in the case of EE ≥ 27 points. Moderate burnout will be considered in the case of 26<EE<19 points. Low levels will be considered for EE≤18 points."|Baseline to 8 weeks|16 PGY1, 13 PGY2, &15 PGY3 participated in study. Data not available in 1 PGY1 participant in exercise intervention period. Data not available to assess change after usual exercise period for 1 PGY2 participant. Data not available for 1 PGY3 participnt for baseline or change in usual exercise period, & change in 1 participant exercise intervention.|||units on a scale||Standard Deviation|Mean
2528762|NCT03486392|Secondary|Change From Baseline in Body Weight at Week 26|Change from baseline in body weight at Week 26 was reported.|Baseline, Week 26|mITT population included all ITT participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement; for liraglutide, only those who titrated to 3.0 mg were included in mITT population. N (number of participants analyzed) = participants evaluable for this outcome measure.|||kg||Standard Error|Least Squares Mean
2528746|NCT03489720|Primary|The Change in the Personal Accomplishment (PA) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase.|"The change in the Personal Accomplishment (PA) burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase.~MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS PA score includes 8 items to evaluate Personal Accomplishment (PA) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS PA total score ranges from 0 to 48 points. We consider a high degree of burnout in the case of PA≥ 39 points. Moderate burnout will be considered in the case of 32-38 PA points. Low levels will be considered for PA ≤31 points."|Baseline to 8 weeks|Data was available for analysis of change for 43 (exercise intervention) and 42 (usual exercise)|||units on a scale||Standard Deviation|Mean
2528747|NCT03489720|Primary|The Change in the Depersonalization (DP) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase.|"The change in the Depersonalization (DP) burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase.~MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS DP score includes 5 items to evaluate depersonalization (DP) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS DP total score ranges from 0 to 30 points. We consider a high degree of burnout in the case of DP≥ 13 points. Moderate burnout will be considered in the case of 7-12 DP points. Low levels will be considered for DP ≤6 points."|Baseline to 8 weeks|Data was not available to analyze the change from baseline in one participant for the exercise intervention period.|||units on a scale||Standard Deviation|Mean
2528748|NCT03489720|Primary|The Change in the Emotional Exhaustion (EE) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI)From Baseline to End of Each Exercise Phase.|"The change in the Emotional Exhaustion (EE) burnout score(as measured by the Maslach Burnout Inventory (MBI)from baseline to end of each exercise phase.~MBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS EE score includes 9 items to evaluate emotional exhaustion (EE), with scores ranging from 0 to 6 on the Likert scale. MBI-HSS EE total score ranges from 0 to 54 points. We consider a high degree of burnout in the case of EE ≥ 27 points. Moderate burnout will be considered in the case of 26<EE<19 points. Low levels will be considered for EE≤18 points."|Baseline to 8 weeks|"Data was not available for analysis of baseline data for 1 participant in each exercise phase.~Data was not available for analysis of change in MBI-EE for 2 participants in each exercise phase."|||units on a scale||Standard Deviation|Mean
2528749|NCT03489551|Primary|Side Effects and Tolerability of Haldol in Patients With Undergoing Hematopoietic Stem Cell Transplant|Categorize and quantify adverse events from start of drug (day 1) to end of study drug per (CTCAE) version 4.0|Daily, up to 14 days following transplant|Participants completing treatment|||Adverse Event|||Number
2528750|NCT03489304|Secondary|Quick Inventory of Depressive Symptomatology (QIDS)|The Quick Inventory of Depressive Symptomatology (QIDS) is a validated mood scale that quantifies depression symptoms. The total score ranges from 0-48, where higher values indicate greater depressive symptoms.|Measure at 6 weeks||||score on a scale||Standard Deviation|Mean
2528751|NCT03489304|Secondary|Epworth Sleepiness Scale (ESS)|The Epworth Sleepiness Scale (ESS) is a validated sleep scale that quantifies daytime sleepiness across eight domains. The total score ranges from 0-24 where higher values indicate greater daytime sleepiness.|Measure at 6 weeks||||score on a scale||Standard Deviation|Mean
2528752|NCT03489304|Primary|Insomnia Severity Index (ISI)|The Insomnia Severity Index is a validated sleep scale that measures clinical insomnia severity. The total score ranges from 0-28 where higher values indicate increased severity of insomnia.|Measure at 6 weeks||||score on a scale||Standard Deviation|Mean
2528753|NCT03488108|Secondary|Adverse Event of Redness on Scalp|Total number of participants experiencing Redness on Scalp was measured after both interventions, in each Arm/Group.|after 12 weeks of treatment||||Participants|||Count of Participants
2528754|NCT03488108|Secondary|Adverse Event of Swelling on Scalp|Total number of participants experiencing swelling on scalp was measured after both interventions, in each Arm/Group.|after 12 weeks of treatment||||Participants|||Count of Participants
2528755|NCT03488108|Primary|Change in Cumulative Thickness|Phototrichograms of all scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the total sum of thickness of each hair was measured after both interventions, in each Arm/Group.|baseline, after 12 weeks of treatment|One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only.|||percent change||Inter-Quartile Range|Median
2528756|NCT03488108|Primary|Change in Terminal Hair Density|Phototrichograms of all scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the total number of Terminal hairs per cm2 was measured after both interventions, in each Arm/Group.|baseline, after 12 weeks of treatment|One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only.|||percent change||Inter-Quartile Range|Median
2528757|NCT03488108|Primary|Change in Vellus Hair Density|Phototrichograms of all scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the total number of vellus hairs per cm2 was measured after both interventions, in each Arm/Group.|baseline, after 12 weeks of treatment|One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only.|||percent change||Inter-Quartile Range|Median
2528758|NCT03488108|Primary|Change in Hair Count|Phototrichograms of all scalps performed using FotoFinder video-epiluminescence microscopy (FotoFinder Systems GmbH) in combination with TrichoScan digital image analysis (TRICHOLOG GmbH and DatInf mbH). The percent change in the total number of hairs per 0.65 cm2 was measured after both interventions, in each Arm/Group.|baseline, after 12 weeks of treatment|One subject dropped out of the study after received PRP treatment only. This subject is included in results information regarding PRP only.|||percent change||Inter-Quartile Range|Median
2528759|NCT03487588|Secondary|Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction|Effectiveness of treatment assessed by PLA (4-point scale) compared to subject reported satisfaction with treatment. The PLA scale is a 4 point scale used by the investigator to assess each subject's SK lesion.|Day 113||||point bi-serial correlation coefficient|||Number
2528763|NCT03486392|Secondary|Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26|Number of participants with >= 10 % body weight loss from baseline to Week 26 were reported.|Week 26|mITT population included all ITT participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement; for liraglutide, only those who titrated to 3.0 mg were included in mITT population.|||Participants|||Count of Participants
2528764|NCT03486392|Secondary|Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26|Number of participants with >= 5% body weight loss from baseline to Week 26 were reported.|Week 26|mITT population included all ITT participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement; for liraglutide, only those who titrated to 3.0 mg were included in mITT population.|||Participants|||Count of Participants
2528765|NCT03486392|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A TEAE was defined as an AE with an onset after the initiation study drug and before the last study drug date of the double-blind (26-week) treatment phase for plus 28 days for liraglutide participants, and plus 35 days for JNJ-64565111 and placebo participants.|Up to Week 30|Safety analysis set included all randomized participants who had received at least one dose of study drug.|||Participants|||Count of Participants
2528766|NCT03486392|Primary|Percent Change From Baseline in Body Weight at Week 26|Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported.|Baseline, Week 26|Modified intent-to-treat (mITT) population included all ITT participants who had taken at least 1 dose of study drug and had at least 1 post-baseline body weight measurement; for liraglutide, only those who titrated to 3.0 mg were included in mITT population. N (number of participants analyzed) = participants evaluable for this outcome measure.|||Percent Change||Standard Error|Least Squares Mean
2528767|NCT03483896|Secondary|Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH)|The Neuropsychiatric Inventory Nursing Home Version (NPI-NH) was used to measure neuropsychiatric symptomatology. The NPI-NH is a scale designed for assessment of people with dementia residing in extended care facilities. The NPI-NH includes ten behavioral areas (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior) and two types of neurovegetative changes (sleep and nighttime behavior disorders, appetite and eating disorders). Each of the 12 areas is scored on a subscale ranging from 0-12, where higher scores indicate greater neuropsychiatric symptomatology. A summary score is obtained from summing all 12 subscale scores. The summary score ranges from 0 - 144, where higher scores indicate greater neuropsychiatric symptomatology.|A NPI-NH score was taken at the beginning of the 12-week study and once again at the end of the 12-week study.||||Units on NPH-NH scale||Standard Error|Mean
2528768|NCT03483896|Primary|Change in Cornell Scale for Depression in Dementia (CSDD)|The Cornell Scale for Depression in Dementia (CSDD) was used to measure depression. The CSDD is designed for the assessment of depression in older people with dementia who can at least communicate basic needs. The CSDD scale ranges from 0 to 38, with higher scores indicating higher levels of depression. Scores above 10 indicate a probable major depression. Scores above 18 indicate a definite major depression. Scores below 6 are associated with absence of significant depressive symptoms.|A CSDD score was taken at the beginning of the 12-week study and once again at the end of the 12-week study.|Included patients with CSDD obtained within 4 months of start of study, leading to 28 analyzed for the control group (of 31) and 38 analyzed for the Daylight Intervention group (of 46). Baseline means and SDs reported here do not account for clustering within facility.|||units on CSDD scale||Standard Error|Mean
2528769|NCT03483623|Primary|Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg|Determine the difference in the pressure redistribution qualities between the WELP when used on the NATO litter and Raven litter. Pressure redistribution will be measured over vulnerable bony prominences as total area of body exposed to skin interface pressures exceeding 30 mm Hg while subjects are in the supine position at 15 minutes. This measure will be expressed as cm2 and the mean will be reported|15 minutes||||cm2||Standard Deviation|Mean
2528770|NCT03483623|Primary|Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg|Determine the difference in the pressure redistribution qualities between the WELP when used on the NATO litter and Raven litter. Pressure redistribution will be measured over vulnerable bony prominences as total area of body exposed to skin interface pressures exceeding 30 mm Hg while subjects are in the supine position at 10 minutes. This measure will be expressed as cm2 and the mean will be reported|10 minutes||||cm2||Standard Deviation|Mean
2528771|NCT03483623|Primary|Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg|Determine the difference in the pressure redistribution qualities between the WELP when used on the NATO litter and Raven litter. Pressure redistribution will be measured over vulnerable bony prominences as total area of body exposed to skin interface pressures exceeding 30 mm Hg while subjects are in the supine position at 5 minutes. This measure will be expressed as cm2 and the mean will be reported|5 minutes||||cm2||Standard Deviation|Mean
2528772|NCT03483623|Primary|Pressure Redistribution: Total Surface Area (TSA) > 30 mm Hg|Determine the difference in the pressure redistribution qualities between the WELP when used on the NATO litter and Raven litter. Pressure redistribution will be measured over vulnerable bony prominences as total area of body exposed to skin interface pressures exceeding 30 mm Hg while subjects are in the supine position at 0 minutes. This measure will be expressed as cm2 and the mean will be reported|0 minutes||||cm2||Standard Deviation|Mean
2528788|NCT03482453|Secondary|Parts 2 and 3: Number of Participants With Clinically Significant Abnormal Vital Signs||Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)|The safety set included all participants who received any study treatment.|||Participants|||Count of Participants
2528789|NCT03482453|Secondary|Parts 2 and 3: Number of Participants With Clinically Significant Abnormal Laboratory Values||Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)|The safety set included all participants who received any study treatment.|||Participants|||Count of Participants
2528773|NCT03483623|Primary|Pressure Redistribution: Peak Pressure Index|Determine the difference in the pressure redistribution qualities between the WELP and the Dolphin FIS when used as mattress on the NATO litter and Raven litter. Pressure redistribution qualities will be measured in mmHg using XSensor X3 pressure mapping technology. To minimize the risk of a faulty sensor or false reading over one sensor, the average of eight cells around the region will be recorded and referred to as the Peak Pressure Index (PPI). Peak interface pressure is the highest average pressure (mm Hg) measured over vulnerable bony prominences (occiput, sacrum, and bilateral scapula, buttocks, and heels) at 15 minutes. PPI will be measured in mm Hg and the mean will be reported|15 minutes||||mm Hg||Standard Deviation|Mean
2528774|NCT03483623|Primary|Pressure Redistribution: Peak Pressure Index|Determine the difference in the pressure redistribution qualities between the WELP and the Dolphin FIS when used as mattress on the NATO litter and Raven litter. Pressure redistribution qualities will be measured in mmHg using XSensor X3 pressure mapping technology. To minimize the risk of a faulty sensor or false reading over one sensor, the average of eight cells around the region will be recorded and referred to as the Peak Pressure Index (PPI). Peak interface pressure is the highest average pressure (mm Hg) measured over vulnerable bony prominences (occiput, sacrum, and bilateral scapula, buttocks, and heels) at 10 minutes. PPI will be measured in mm Hg and the mean will be reported|10 minutes||||mm Hg||Standard Deviation|Mean
2528775|NCT03483623|Primary|Pressure Redistribution: Peak Pressure Index|Determine the difference in the pressure redistribution qualities between the WELP and the Dolphin FIS when used as mattress on the NATO litter and Raven litter. Pressure redistribution qualities will be measured in mmHg using XSensor X3 pressure mapping technology. To minimize the risk of a faulty sensor or false reading over one sensor, the average of eight cells around the region will be recorded and referred to as the Peak Pressure Index (PPI). Peak interface pressure is the highest average pressure (mm Hg) measured over vulnerable bony prominences (occiput, sacrum, and bilateral scapula, buttocks, and heels) at 5 minutes. PPI will be measured in mm Hg and the mean will be reported|5 minutes||||mm Hg||Standard Deviation|Mean
2528776|NCT03483623|Primary|Pressure Redistribution: Peak Pressure Index|Determine the difference in the pressure redistribution qualities between the WELP and the Dolphin FIS when used as mattress on the NATO litter and Raven litter. Pressure redistribution qualities will be measured in mmHg using XSensor X3 pressure mapping technology. To minimize the risk of a faulty sensor or false reading over one sensor, the average of eight cells around the region will be recorded and referred to as the Peak Pressure Index (PPI). Peak interface pressure is the highest average pressure (mm Hg) measured over vulnerable bony prominences (occiput, sacrum, and bilateral scapula, buttocks, and heels) at 0 minutes. PPI will be measured in mm Hg and the mean will be reported|0 minutes||||mm Hg||Standard Deviation|Mean
2528777|NCT03483051|Secondary|Late Systolic Left Ventricle Load|The effect of KNO3 on last systolic left ventricle load from wave reflections (assessed via comprehensive aortic pressure-flow regulations, using arterial tonometry and Doppler echocardiography)|9 weeks|||||||
2528778|NCT03483051|Secondary|Myocardial Systolic Strain|The effect of KNO3 on myocardial strain (assessed with speckle-tracking echocardiography)|9 weeks|||||||
2528779|NCT03483051|Secondary|Left Ventricle Diastolic Function|The effect of KNO3 on left ventricle diastolic filling parameters (measured with echocardiography at rest and after peak exercise)|9 weeks|||||||
2528780|NCT03483051|Secondary|Systemic Vasodilator Response to Exercise|The effect of KNO3 on systemic vasodilator response, measured by change in systemic vascular resistance, during a symptom-limited maximal exercise test,|9 weeks|||||||
2528781|NCT03483051|Primary|Quality of Life Score|The effect of KNO3 on quality of life, assessed using the Kansas City Cardiomyopathy Questionnaire.|9 weeks|||||||
2528782|NCT03483051|Primary|Peak Oxygen Uptake (VO2) During a Maximal Effort Exercise Test|The effect of KNO3 on exercise capacity, quantified as: Peak oxygen consumption (VO2) during a symptom-limited maximal effort exercise test.|9 weeks|||||||
2528783|NCT03483051|Primary|Total Work Performed During a Maximal-effort Exercise Test|The effect of KNO3 on exercise capacity, quantified as Total work performed during a maximal-effort exercise test;|9 weeks|Efficacy data analyses cannot be reported for privacy reasons due to enrollment of only three (3) subjects.||||||
2528784|NCT03482713|Secondary|Change From Baseline at Week 4 in Log-transformed Awake Coughs Per Hour|Change from baseline at Week 4 in awake coughs per hour is the average hourly cough frequency (based on sound recordings) during the 24-hour monitoring period while the participant is awake. Change from baseline in log-transformed awake coughs per hour = log (awake coughs per hour at post-baseline) - log (awake coughs per hour at baseline) for the monitoring period the participant is awake.|Baseline and Week 4|All randomized participants who have taken at least one dose of study medication and provided at least one baseline and one post-baseline awake cough observations during the treatment period.|||Coughs/hour||Standard Error|Least Squares Mean
2528785|NCT03482713|Secondary|Change From Baseline at Week 4 in Log-transformed 24-hour Coughs Per Hour|Cough frequency will be evaluated using a digital recording device which records sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone. Change from baseline in log-transformed 24-hour coughs per hour = log (24-hour coughs per hour at post-baseline) - log (24-hour coughs per hour at baseline). The denominators may be different if the recording period is actually <24 hours but ≥20 hours).|Baseline and Week 4|All randomized participants who have taken at least one dose of study medication and provided at least one baseline and one post-baseline 24-hour cough observations during the treatment period.|||Coughs/hour||Standard Error|Least Squares Mean
2528786|NCT03482713|Primary|Number of Participants Who Discontinued Study Treatment Due to an Adverse Event|An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.|Up to 4 weeks|All randomized participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2528787|NCT03482713|Primary|Number of Participants Who Experienced an Adverse Event|An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.|Up to 6 weeks|All randomized participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2528835|NCT03479216|Secondary|Number of Participants With Complications Due to Intraarticular Injection|post-injection complications due to intraarticular injection will be noted.|24 hours||||Participants|||Count of Participants
2528790|NCT03482453|Secondary|Parts 2 and 3: Number of Participants With One or More SAEs||Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)|The safety set included all participants who received any study treatment.|||Participants|||Count of Participants
2528791|NCT03482453|Secondary|Parts 2 and 3: Number of Participants Reporting One or More TEAEs||Baseline up to 30 days after the last dose of study drug (Day 38) (end of Intervention Period 2)|The safety set included all participants who received any study treatment.|||Participants|||Count of Participants
2528792|NCT03482453|Secondary|Part 1, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788 and Its Active Metabolites AP32960 and AP32914||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters. The PK analysis population where data at specified time points were available.|||hour||Standard Deviation|Geometric Mean
2528793|NCT03482453|Secondary|Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788 and Its Active Metabolites AP32960 and AP32914||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters. The PK analysis population where data at specified time points were available.|||h*ng/mL||Standard Deviation|Geometric Mean
2528794|NCT03482453|Secondary|Part 1, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788 and Its Active Metabolites, AP32960 and AP32914||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.|||h*ng/mL||Standard Deviation|Geometric Mean
2528795|NCT03482453|Secondary|Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788 and Its Active Metabolites AP32960 and AP32914||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.|||hour||Full Range|Median
2528796|NCT03482453|Secondary|Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-788 and Its Active Metabolites AP32960 and AP32914||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2528797|NCT03482453|Primary|Part 3, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.|||hour||Standard Deviation|Geometric Mean
2528798|NCT03482453|Primary|Part 2, t1/2z: Terminal Disposition Phase Half-life (t1/2z) for TAK-788||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.|||hour||Standard Deviation|Geometric Mean
2528799|NCT03482453|Primary|Part 3, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.|||h*ng/mL||Standard Deviation|Geometric Mean
2528800|NCT03482453|Primary|Part 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-788||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.|||h*ng/mL||Standard Deviation|Geometric Mean
2528801|NCT03482453|Primary|Part 3, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.|||h*ng/mL||Standard Deviation|Geometric Mean
2528802|NCT03482453|Primary|Part 2, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-788||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Geometric Mean
2528803|NCT03482453|Primary|Part 3, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.|||hour||Full Range|Median
2528804|NCT03482453|Primary|Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-788||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.|||hour||Full Range|Median
2528805|NCT03482453|Primary|Part 3, Cmax: Maximum Observed Plasma Concentration for TAK-788||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The PK set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2528806|NCT03482453|Primary|Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-788||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The pharmacokinetic (PK) set included all participants in the safety set who had no major protocol deviations that would have affected the PK analysis and who had sufficient data to calculate PK parameters.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2528836|NCT03479216|Secondary|Mobilization|First mobilization time after surgery|24 hours||||minutes||Full Range|Mean
2528807|NCT03482453|Primary|Part 1: Number of Participants With Clinically Significant Abnormal Vital Signs||Baseline up to 30 days after the last dose of study drug (Day 31)|The safety set included all participants who received any study treatment.|||Participants|||Count of Participants
2528808|NCT03482453|Primary|Part 1: Number of Participants With Clinically Significant Abnormal Laboratory Values||Baseline up to 30 days after the last dose of study drug (Day 31)|The safety set included all participants who received any study treatment.|||Participants|||Count of Participants
2528809|NCT03482453|Primary|Part 1: Number of Participants With One or More Serious Adverse Events (SAEs)||Baseline up to 30 days after the last dose of study drug (Day 31)|The safety set included all participants who received any study treatment.|||Participants|||Count of Participants
2528810|NCT03482453|Primary|Part 1: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)||Baseline up to 30 days after the last dose of study drug (Day 31)|The safety set included all participants who received any study treatment.|||Participants|||Count of Participants
2528811|NCT03481309|Secondary|Changes in Resting-state EEG Dynamics Ratios (Unit: uV)|The investigators will record participants' resting state for 4 minutes using EEG (2 minutes for eyes-closed and 2 minutes for eyes-open)|4 minutes recordings before and after each 2mA tDCS stimulation for 10 minutes at each session|One participant signed the consent form but data for this participant was not recorded.|||Ratio (unit: uV)||Standard Deviation|Mean
2528812|NCT03481309|Primary|Changes in TMS-evoked Potentials Ratios (Unit: uV)|The investigators will record TMS-evoked potentials using EEG and calculate changes in between before and after 2mA tDCS stimulation for 10 minutes.|right before and after 2mA tDCS stimulation for 10 minutes at each session|One participant signed the consent form but data for this participant was not recorded.|||Ratio (unit: uV)||Standard Deviation|Mean
2528813|NCT03481309|Primary|Changes in Motor-evoked Potentials Ratios (Unit: uV)|The investigators will record motor-evoked potentials and calculate changes in between before and after 2mA tDCS stimulation for 10 minutes.|right before and after 2mA tDCS stimulation for 10 minutes at each session|One participant signed the consent form but data for this participant was not recorded.|||Ratio (unit: uV)||Standard Error|Mean
2528814|NCT03481270|Primary|Average Take-up of Preventive Services (Post-consultation)|Take-up of preventative services was scored as either zero (did not utilize any post-consultation services) or 1 (utilized at least 1 post-consultation service). Four non-incentivized post-consultation preventive services were offered (for BMI, blood pressure, cholesterol, and/or diabetes); the subject had the opportunity to select service(s) after meeting with their assigned doctor.|1 day||||score on a scale||Standard Deviation|Mean
2528815|NCT03480919|Secondary|Anxiety Medication Use|Any use of medication use following the acupuncture intervention and before the epidural injection will be documented.|Up to 30 min post-acupuncture intervention.||||Participants|||Count of Participants
2528816|NCT03480919|Secondary|Belief of Acupuncture|"Patients will be asked On a scale of 0-10, how much do you believe acupuncture to be a valid treatment for anxiety? (0=do not believe at all; 10=fully believe)"|Up to 30 min post-acupuncture intervention||||units on a scale||Standard Deviation|Mean
2528817|NCT03480919|Primary|Anxiety|Change in anxiety from baseline (pre-acupuncture intervention) will be measured using the State subscale of the State Trait Anxiety Inventory (STAI). The STAI is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI is one of the first tests to assess both state and trait anxiety separately. Each type of anxiety has its own scale of 20 different questions that are scored. Scores range from 20 to 80, with higher scores correlating with greater anxiety. Low scores indicate a mild form of anxiety whereas median scores indicate a moderate form of anxiety and high scores indicate a severe form of anxiety. The 4-point scale for S-anxiety is as follows: 1.) not at all, 2.) somewhat, 3.) moderately so, 4.) very much so. The 4-point scale for T-anxiety is as follows: 1.) almost never, 2.) sometimes, 3.) often, 4.) almost always.|Up to 30 min post-acupuncture intervention||||score on a scale||Standard Deviation|Mean
2528818|NCT03480841|Secondary|Generalized Anxiety Disorder (7-Item) Score at 6 Weeks|The Generalized Anxiety Disorder 7-item (GAD-7) is a self-report screening of anxiety symptoms examining frequency the of specific behaviors within the last two-weeks (e.g., not at all - nearly every day). A total score is calculated and compared to pre-determined cutoffs to help guide professionals in next steps for evaluation and treatment.The GAD-7 consists of seven items which are scored from zero to three. Scores range from 0-21, with higher scores reflecting more severe anxiety symptoms. The cut-off scores for mild, moderate and severe anxiety symptoms are 5, 10 and 15 respectively.|at 6 weeks||||units on a scale||Standard Deviation|Mean
2528819|NCT03480841|Secondary|LENA Child Vocalization Score at 6 Weeks|The LENA system, which records adult-child vocalizations, measures the number of vocalizations of the target child. The total possible range is 0-n, where higher scores indicate an increased number of vocalizations from the child, reflecting higher levels of language development. Lower scores indicate fewer vocalizations from child, and represent lower levels of language development.|at 6 weeks||||number of vocalizations||Standard Deviation|Mean
2528820|NCT03480841|Secondary|LENA Mother/Child Turn-Taking Score at 6 Weeks|"The LENA system, which records adult-child vocalizations, measures the number of conversational turns between the target adult (e.g., parent) and child. The total possible range is 0-n, where higher scores indicate an increased number of turns (back-and-forth, or reciprocal language exchanges) between the adult and child, reflecting higher degrees of a language-rich environment. Lower scores indicate fewer conversational turns between the adult and child, and represent an environment that is not language-rich."|at 6 weeks||||number of turns||Standard Deviation|Mean
2528821|NCT03480841|Secondary|Patient Health Questionnaire-9 (PHQ-9) Score at 6 Weeks|"The Patient Health Questionnaire - 9 (PHQ-9) is a depression scale used to assess brief depression severity by rating symptoms and functional impairment experienced in the last two weeks. Nine questions are scored on a range from 0-3; 0 = not at all, 1 =several days, 2 = more than half the days, and 3 = nearly every day. The total possible range is 0-27, with higher scores indicating more depressive symptoms (0-4 = minimal depression, 5-9 = mild depression, 10-14 = moderate depression, 15-19 = moderately severe depression, and 20-27 = severe depression)."|at 6 weeks||||units on a scale||Standard Deviation|Mean
2528837|NCT03479216|Secondary|Time to the End of Spinal Anesthesia|time from the start of spinal anesthesia (total block = Bromage 3) to the end of spinal anesthesia (Bromage 0)|24 hours||||minutes||Full Range|Mean
2528822|NCT03480841|Secondary|Parenting Sense of Competence Scale Efficacy Subscale Score at 6 Weeks|"The Parenting Sense of Competence Scale is a 17-item measure assessing parental competence. Each item is rated on a 6 point Likert scale anchored by 1 = Strongly Disagree and 6 = Strongly Agree. The Efficacy subscale measures feelings of efficacy as a parent. It has 7 questions (1,6,7,10,11,13,15), producing a range of 6-42. Higher scores indicate greater self-efficacy. Lower scores mean more impairment."|at 6 weeks||||units on a scale||Standard Deviation|Mean
2528823|NCT03480841|Primary|LENA Adult Word Count Score at 6 Weeks|The Language Enhancement/Intervention System (LENA), which records adult-child vocalizations, measures the number of the target adult's (e.g., parent) child-directed words (child-directed speech). The total possible range is 0-n, where higher scores indicate an increased number of child-directed words spoken by the target adult and higher degrees of a language-rich environment. Lower scores indicate fewer words spoken by the target adult and represent an environment that is not language-rich.|at 6 weeks||||number of words||Standard Deviation|Mean
2528824|NCT03480152|Other Pre-specified|Maximum Tolerated Dose (MTD|A MTD is the highest dose at which ≤1 of 6 patient's experienced a dose limiting toxicity (i.e., All Grade 3 or greater toxicities related to the messenger ribonucleic acid vaccine with exception of Grade 3 fever, Grade 3 pruritic/itching, Grade 3 fatigue, Grade 3 metabolic laboratory abnormalities without significant clinical sequela that resolves to Grade 2 or less within 7 days, Grade 3 autoimmune toxicity that resolves to Grade 2 or less in 7 days and events that are clearly related to the patient's disease.) or the highest dose level studied if DLT's are not observed at any of the dose levels.|Up to 21 days after the first vaccination|MTD was not reached.||||||
2528825|NCT03480152|Other Pre-specified|Number of Dose Limiting Toxicities (DLT)|A DLT is all Grade 3 or greater toxicities related to the messenger ribonucleic acid vaccine with exception of Grade 3 fever, Grade 3 pruritic/itching, Grade 3 fatigue, Grade 3 metabolic laboratory abnormalities without significant clinical sequela that resolves to Grade 2 or less within 7 days, Grade 3 autoimmune toxicity that resolves to Grade 2 or less in 7 days and events that are clearly related to the patient's disease.|Up to 21 days after the first vaccination||||toxicities|||Number
2528826|NCT03480152|Other Pre-specified|Number of Participants With Non-Serious Adverse Events Regardless of Attribution|Here is the count of participants with non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence.|Date treatment consent signed to date off study, approximately 11 months and 4 days.|No participants experienced serious adverse events on this study.|||Participants|||Count of Participants
2528827|NCT03480152|Secondary|Number of Participants With an Increase in the Quantity and Quality of Circulating Antigen-specific T Cells|Participants blood samples were assessed by fluorescence-activated cell sorting (FACS), enzyme-linked immune absorbent (ELISA)-spot and human soluble cluster of differentiation 137 (CD137) (4-1BB) upregulation assays. Differences of 2-3 fold in these assays over the baseline measures are indicative of true biologic difference.|Approximately 2 weeks after last vaccine||||Participants|||Count of Participants
2528828|NCT03480152|Primary|Number of Non-Serious Adverse Events Probably Related to Treatment|Here is the number of non-serious adverse events probably related to treatment assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).|During treatment and up to 30 days after the first follow- up evaluation (at the second follow-up evaluation)||||adverse events|||Number
2528829|NCT03480152|Primary|Number of Participants Who Had a Clinical Response (Complete Response + Partial Response) to Treatment (Objective Tumor Regression)|Clinical response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|up to 12 months||||Participants|||Count of Participants
2528830|NCT03480048|Primary|Change in Weight From Baseline|Weight at 20 weeks postpartum minus pre-pregnancy weight.|Baseline and 20 weeks postpartum||||pounds||Standard Deviation|Mean
2528831|NCT03480048|Primary|Number of Participants Still Breastfeeding at 20 Weeks Postpartum|Count of women who report any breastfeeding at 20 weeks postpartum|20 weeks postpartum||||Participants|||Count of Participants
2528832|NCT03479944|Secondary|Percentage of Average Torsional Amplitude|Torsional amplitude (the amplitude of the oscillations of the phacoemulsification tip) was reported on the Centurion® Vision System interface as a percentage from 0 to 100, where 100 represents maximum amplitude. A lower percentage value indicates greater efficiency in the phacoemulsification process.|Day 0 (operative day)|Full Analysis Set|||percentage of avg torsional amplitude|eyes|Standard Deviation|Mean
2528833|NCT03479944|Secondary|Percent Change of Corneal Endothelial Cell Density (ECD) at Visit 5 (150-210 Days After Surgery) From Pre-Operative Visit|Central endothelial cell counts were assessed using specular microscopy. ECD was measured in cells per square millimeter (mm2). The endothelium maintains corneal hydration, and positive percent change value indicates an improvement. In turn, a less negative percent change value is preferable over a more negative percent change value.|Preoperative, Day 150-210 (post-operative)|Full Analysis Set|||percent change|eyes|Standard Deviation|Mean
2528834|NCT03479944|Primary|Cumulative Dissipated Energy (CDE)|CDE is not expressed in standard units such as Watts or Joules and accounts for the power and time of longitudinal and torsional ultrasound delivery modes. CDE (the sum total of phacoemulsification energy dissipated at the incision point during the removal of cataractous lens with Centurion® Vision System footpedal in Position 3) was calculated by the Centurion® Vision System as follows: CDE = (Longitudinal time) x (Average longitudinal power) + (Torsional time x 0.4 x Average torsional amplitude). A lower CDE value indicates that less energy was expended in the eye.|Day 0 (operative day)|All eyes with successful cataract surgery for which anterior capsulotomy and lens fragmentation have been completed using the assigned surgical techniques (Full Analysis Set).|||unitless|eyes|Standard Deviation|Mean
2528839|NCT03479216|Secondary|Rescue Analgesic Time|Time to first analgesic demand at the orthopedics ward (from intraarticular injection to first analgesic requirement)|24 hours|Time to first analgesic demand at the orthopedics ward (from intra-articular injection to first analgesic requirement) was calculated in minutes among patients who required analgesics|||minutes||Full Range|Mean
2528840|NCT03479216|Secondary|Postoperative Opioid/NSAID Consumption|nonsteroid antiinflammatory drugs (NSAID) or opioid drugs that are applied to patients will be noted.|24 hours||||vials|||Number
2528841|NCT03479216|Primary|Postoperative Pain|postoperative pain scores (rest and movement) (ward) Pain scores were assessed with a 10-cm Visual Analogue Scale (VAS) (with 0 = no pain and 10 = the worst imaginable pain)|24 hours|visual analogue scale (VAS) scores at rest at 2nd hour (VAS2 R), 4th hour (VAS4 R), 6th hour (VAS6 R), 8th hour (VAS8 R), 12th hour (VAS12 R), 18th hour (VAS18 R) VAS scores at movement at 2nd hour (VAS2 M), 4th hour (VAS4 M), 6th hour (VAS6 M), 8th hour (VAS8 M), 12th hour (VAS12 M), 18th hour (VAS18 M)|||score on a scale||Full Range|Mean
2528842|NCT03478891|Secondary|Number of Subjects Who Produced Anti-drug Antibodies to MAb114|Serum samples collected 28 days and 56 days after MAb114 administration|Days 28 and 56 post-infusion|Subjects with serum samples collected at 28 days and 56 days.|||Participants|||Count of Participants
2528843|NCT03478891|Secondary|MAb114 Clearance Rate|Rate of MAb114 elimination divided by the plasma MAb114 concentration; determined based on the summary PK curve for each study group.|Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusion|Subjects with 28 days of pharmacokinetic data.|||mL/day||Standard Deviation|Mean
2528844|NCT03478891|Secondary|Volume of Distribution (Vd) at Steady-state|Theoretical volume that would be necessary to contain the total amount of administered drug at the same concentration as observed in plasma. It represents the degree to which a drug is distributed in body tissue rather than the plasma and calculated based in the PK curve for each study group.|Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusion|Subjects with 28 days of pharmacokinetic data.|||Liters||Standard Deviation|Mean
2528845|NCT03478891|Secondary|Area Under the Curve (AUC0-28D)|The AUC0-28D represents the total drug exposure in 28 days after MAb114 administration; it is determined based on the summary PK curve for each group.|Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusion|Subjects with 28 days of pharmacokinetic data.|||µg x day/mL||Standard Deviation|Mean
2528846|NCT03478891|Secondary|Overall IV Half-life (T1/2) of MAb114|Half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.|Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-56 days post-infusion|Subjects with 56 days of pharmacokinetic data. No standard deviation reported for a Group 3 single subject data.|||days||Standard Deviation|Mean
2528847|NCT03478891|Secondary|Mean Serum Concentration of MAb114|The mean of individual subject MAb114 serum concentrations by administered dose group|Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusion|Subjects with 28 days of pharmacokinetic data.|||µg/mL||Standard Deviation|Mean
2528848|NCT03478891|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) of MAb114|Tmax is the time it takes to reach Cmax of MAb114 after it has been administered; it is determined based on the summary PK curve for each study group.|Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusion|Subjects with 28 days of pharmacokinetic data.|||hours||Standard Deviation|Mean
2528849|NCT03478891|Secondary|Maximum Observed Serum Concentration (Cmax) of MAb114|Cmax is the peak serum concentration that MAb114 achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.|Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusion|Subjects with 28 days of pharmacokinetic data.|||µg/mL||Standard Deviation|Mean
2528850|NCT03478891|Primary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events (SAEs) collected during the period from study product administration at Day 0 through 24 weeks after product administration. Grading done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.1. The relationship between a SAE and the product was assessed by the investigator on the basis of his or her clinical judgment and the protocol-specific definitions of Related - There is a reasonable possibility that the SAE may be related to the study product and Not Related - There is not a reasonable possibility that the SAE is related to the study product.|Through 24 weeks after product administration|Subjects who received MAb114 (N=18), where “N” signifies number of subjects analyzed for this outcome measure.|||Participants|||Count of Participants
2528851|NCT03478891|Primary|Number of Subjects Reporting 1 or More Unsolicited Non-Serious Adverse Events|"Unsolicited adverse events (AEs) collected during the period from study product administration at Day 0 through 28 days after product administration. After the indicated time period through the last expected study visit at 24 weeks after product administration, only new chronic medical conditions collected as unsolicited AEs.~The number reported is the number of subjects who experienced at least one AE in the reporting period. A subject with multiple experiences of the same event is counted once using the event of worst severity. The relationship between an AE and the product was assessed by the investigator on the basis of his or her clinical judgment and the protocol-specific definitions of Related - There is a reasonable possibility that the AE may be related to the study product and Not Related - There is not a reasonable possibility that the AE is related to the study product."|Through 24 weeks after product administration|Subjects who received MAb114 (N=18), where “N” signifies number of subjects analyzed for this outcome measure.|||Participants|||Count of Participants
2528881|NCT03477903|Secondary|Average Daily Caloric Adequacy|Average daily caloric adequacy received through enteral nutrition was defined by percentage of goal calories achieved per day (percentage calorie goal achieved=actual calorie achievement/total participant-specific target calories). The values in the 5-day period and the 14-day period were averaged.|Days 1 to 5 and Days 1 to 14|Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.||||||
2528882|NCT03477903|Secondary|Average Daily Change in 24-hour Gastric Residual Volume (GRV) Over the First 5 Days of Study Treatment|GRV is defined as the volume of fluid remaining in the stomach at a point in time during enteral nutrition feeding. The value for each of the 5 days was averaged.|Days 1 to 5|Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.||||||
2528852|NCT03478891|Primary|Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration|"Local reactogenicity symptoms were assessed and recorded by clinicians. Solicited local symptoms include pain/tenderness, swelling, redness, bruising, and pruritus (itchiness) at the product administration site. Clinicians assessed the study product administration site for local symptoms on the day of product administration after completion of the administration and on Days 1, 2 and 7 post administration. Subjects were counted once for each symptom at the worst severity if they experienced the symptom at any severity during the reporting period. If symptoms were experienced, clinicians collected resolution information for any symptom that wasn't resolved within 7 days. The number reported for Any Local Symptom is the number of subjects reporting any local symptom as reported at the worst severity. Solicited reactogenicity was recorded without attribution assessment. Grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.1."|7 days after product administration|Subjects who received MAb114 (N=18), where “N” signifies number of subjects analyzed for this outcome measure.|||Participants|||Count of Participants
2528853|NCT03478891|Primary|Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration|"Subjects recorded 3-day systemic reactogenicity symptoms in a diary after study product administration. Solicited systemic symptoms include: unusually tired/feeling unwell, muscles aches, headache, chills, nausea, fever and joint pain. Subjects recorded highest measured temperature daily. Clinicians reviewed the diary with the subject and collected resolution information for any symptoms that were not resolved within 3 days. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for Any Systemic Symptom is the number of subjects experiencing any systemic symptom as reported at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.1."|3 days after product administration|Subjects who received MAb114 (N=18), where “N” signifies number of subjects analyzed for this outcome measure.|||Participants|||Count of Participants
2528854|NCT03478891|Primary|Number of Subjects Experiencing Infusion Reaction During Product Administration|Possible infusion reaction symptoms: unusually tired/feeling unwell, muscles aches, headache, chills, rigors, nausea, fever, joint pain, urticaria/rash, and pruritus. Also information was collected if administration was slowed down or stopped for reactogenicity reasons.|About 30 minutes of product administration|Subjects who received MAb114 (N=18), where “N” signifies number of subjects analyzed for this outcome measure.|||Participants|||Count of Participants
2528855|NCT03478696|Primary|Weighted Mean Change From Baseline in FEV1 Over 0-24 Hours at Week 12 for ITT Population|FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period at Week 12. Weighted mean change from Baseline at week 12 was calculated by subtracting weighted mean FEV1 at week 12 from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The weighted mean was derived by calculating the area under the FEV1 time curve (AUC) over the actual time of assessment relative to the time of dosing (over 24-hour period) using the trapezoidal rule, and then dividing the value by the time interval (24-hour) over which the AUC was calculated.|Baseline and Week 12|ITT Population comprised of all randomized participants, excluding those who were randomized in error. Only those participants with data available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2528856|NCT03478696|Secondary|Weighted Mean Change From Baseline in FEV1 Over 0-24 Hours on Day 1|FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period on Day 1. Weighted mean change from Baseline on Day 1 was calculated by subtracting weighted mean FEV1 on Day 1 from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The weighted mean was derived by calculating the area under the FEV1 time curve (AUC) over the actual time of assessment relative to the time of dosing (over 24-hour period) using the trapezoidal rule, and then dividing the value by the time interval (24-hour) over which the AUC was calculated.|Baseline and Day 1|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2528857|NCT03478696|Secondary|Change From Baseline in Trough FEV1 on Day 2, Day 28, Day 84 and Day 85|FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. For Day 2 and Day 85, trough FEV1 was defined as the mean of the 23-hour and 24-hour serial spirometry FEV1 measurements. For Day 28 and Day 84, trough FEV1 was defined as the average of the pre-dose FEV1 measurements recorded before the morning dose of randomized study treatment. Change from Baseline in trough FEV1 was calculated by subtracting post-dose trough FEV1 value from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The treatment effect to be estimated for trough FEV1 was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|Baseline, Days 2, 28, 84 and 85|ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Liters||Standard Error|Least Squares Mean
2528883|NCT03477903|Secondary|Average Daily Protein Adequacy Over the Study Treatment Period|Average daily protein adequacy received through enteral nutrition is defined as percentage of goal protein delivered per day, where percentage of protein goal delivered is calculated as the ratio of actual protein achievement to the total participant-specific target protein prescribed. The value for each of the 14 days was averaged.|Days 1 to 14|Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.||||||
2528889|NCT03476278|Secondary|Patient Satisfaction According to Recovery Room Adverse Events|patient satisfaction according to recovery room adverse events following surgery under regional anesthesia|1 day||||adverse events|adverse events||Count of Units
2528858|NCT03478696|Primary|Weighted Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 0-24 Hours at Week 12 for Modified Per Protocol (mPP) Population|FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period at Week 12. Weighted mean change from Baseline at week 12 was calculated by subtracting weighted mean FEV1 at week 12 from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The weighted mean was derived by calculating the area under the FEV1 time curve (AUC) over the actual time of assessment relative to the time of dosing (over 24-hour period) using the trapezoidal rule, and then dividing the value by the time interval (24-hour) over which the AUC was calculated.|Baseline and Week 12|mPP Population comprised of all participants in the ITT population who do not have a protocol deviation of not meeting eligibility criteria or not meeting randomization criteria. Only those participants with data available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2528859|NCT03478683|Primary|Weighted Mean Change From Baseline in FEV1 Over 0-24 Hours at Week 12 for ITT Population|FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period at Week 12. Weighted mean change from Baseline at week 12 was calculated by subtracting weighted mean FEV1 at week 12 from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The weighted mean was derived by calculating the area under the FEV1 time curve (AUC) over the actual time of assessment relative to the time of dosing (over 24-hour period) using the trapezoidal rule, and then dividing the value by the time interval (24-hour) over which the AUC was calculated.|Baseline and Week 12|ITT Population comprised of all randomized participants, excluding those who were randomized in error. Only those participants with data available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2528860|NCT03478683|Secondary|Weighted Mean Change From Baseline in FEV1 Over 0-24 Hours on Day 1|FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period on Day 1. Weighted mean change from Baseline on Day 1 was calculated by subtracting weighted mean FEV1 on Day 1 from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The weighted mean was derived by calculating the area under the FEV1 time curve (AUC) over the actual time of assessment relative to the time of dosing (over 24-hour period) using the trapezoidal rule, and then dividing the value by the time interval (24-hour) over which the AUC was calculated.|Baseline and Day 1|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2528861|NCT03478683|Secondary|Change From Baseline in Trough FEV1 on Day 2, Day 28, Day 84 and Day 85|FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. For Day 2 and Day 85, trough FEV1 was defined as the mean of the 23-hour and 24-hour serial spirometry FEV1 measurements. For Day 28 and Day 84, trough FEV1 was defined as the average of the pre-dose FEV1 measurements recorded before the morning dose of randomized study treatment. Change from Baseline in trough FEV1 was calculated by subtracting post-dose trough FEV1 value from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The treatment effect to be estimated for trough FEV1 was hypothetical effect if all participants stayed on their randomized study treatment. Only on treatment data was included in analysis.|Baseline, Days 2, 28, 84 and 85|ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Liters||Standard Error|Least Squares Mean
2528862|NCT03478683|Primary|Weighted Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 0-24 Hours at Week 12 for Modified Per Protocol (mPP) Population|FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period at Week 12. Weighted mean change from Baseline at week 12 was calculated by subtracting weighted mean FEV1 at week 12 from Baseline FEV1, where Baseline FEV1 is the average of the two FEV1 measurements made at 30 minutes and 5 minutes pre-dose on Day 1. The weighted mean was derived by calculating the area under the FEV1 time curve (AUC) over the actual time of assessment relative to the time of dosing (over 24-hour period) using the trapezoidal rule, and then dividing the value by the time interval (24-hour) over which the AUC was calculated.|Baseline and Week 12|mPP Population comprised of all participants in the ITT population who do not have a protocol deviation of not meeting eligibility criteria or not meeting randomization criteria. Only those participants with data available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2528884|NCT03477903|Primary|Average Daily Protein Adequacy Over the First 5 Days of Treatment|Average daily protein adequacy received through enteral nutrition is defined as the percentage of goal protein delivered per day, where percentage of goal protein delivered is calculated as the ratio of actual protein achievement to the total participant-specific target protein prescribed. The value for each of the 5 days was averaged.|Days 1 to 5|Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.||||||
2528890|NCT03476278|Secondary|Patient Satisfaction According to Intra-operative Adverse Events|patient satisfaction according to intra-operative adverse events under regional anesthesia|1 day||||number of experienced adverse events|adverse events||Number
2544709|NCT02956460|Primary|Overall Comfort|Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel|2 weeks||||units on a scale||Standard Deviation|Mean
2528863|NCT03478657|Secondary|Percentage of Participants Who Reported at Least One Critical Error From Each Stratum With the Use of ELLIPTA DPI at Visit 1, Attempt 1|Participants were trained by HCP in correct use of ELLIPTA DPI at Visit 1 following which participants were assessed on their ability to use the ELLIPTA DPI without guidance from the HCP or parent/guardian. The participants were given a maximum of five attempts. Participants who were unable to use the ELLIPTA DPI correctly were trained by the HCP for the first three attempts. For the fourth and fifth attempts, the participants' parent/guardian assisted in the training of the ELLIPTA DPI. Percentage of participants who has withdrawn at any point throughout the correct use demonstration and performed a critical error, was considered as one who performed at least one critical error. Participant who has withdrawn at any point throughout correct use demonstration and did not perform all the critical error items were also considered as one who performed at least one critical error. The 95% CI for the percentages are calculated using the exact binomial distribution.|Day 1|ITT Population.|||Percentage of participants||95% Confidence Interval|Number
2528864|NCT03478657|Secondary|Percentage of Participants Who Rated Easy Use of ELLIPTA DPI at Visit 2 in All Participants (Stratum 1+Stratum 2)|"Participants were trained in the correct use of ELLIPTA DPI at Visit 1 by the HCP and eligible participants were required to take one inhalation of placebo from the ELLIPTA DPI once daily for 28 days. At Day 28 (Visit 2), participants were administered a questionnaire on the ease of use of ELLIPTA DPI. For participants in Stratum 1, questionnaire was provided to the interviewer and responses were recorded. For Stratum 2, the questionnaire was self-administered (or interviewer administered, if participant was unable to self-administer). Percentage of participants who rated the ELLIPTA DPI as easy to use was calculated as number of participants who rate the ELLIPTA as easy divided by number of participants who demonstrated correct use at Visit 2 (Attempt #1) multiplied by 100. The 95% CI for the percentages are calculated using the exact binomial distribution."|At Day 28|MITT Population. Only those participants who demonstrated correct use at Visit 2, attempt 1 were analyzed.|||Percentage of participants||95% Confidence Interval|Number
2528865|NCT03478657|Secondary|Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA DPI at Visit 2, Attempt 1 in All Participants (Stratum 1+Stratum 2)|"Participants were trained in the correct use of ELLIPTA DPI by a HCP on Day 1 (Visit 1) following which eligible participants were required to take one inhalation of placebo from the ELLIPTA DPI once daily for 28 days. At Day 28 (Visit 2), participants were administered a questionnaire on ease of use of ELLIPTA DPI. Participants and their parents/guardian were required to complete the questionnaire, following which participants were assessed for their ability to demonstrate correct use of ELLIPTA DPI (1 attempt with no training or instruction and then 1 attempt after instruction from parent/guardian). Percentage of participants who demonstrated correct use of ELLIPTA was calculated as number of participants who demonstrated correct use at Visit 2 divided by number of participants whose use of the ELLIPTA DPI was evaluated at Visit 2 multiplied by 100. The 95% CI was calculated using the exact binomial distribution."|At Day 28|MITT Population.|||Percentage of participants||95% Confidence Interval|Number
2528866|NCT03478657|Secondary|Percentage of Participants From Each Stratum Who Demonstrated Correct Use of the ELLIPTA DPI at Visit 1, Attempt 1 (Day 1)|Participants were trained by HCP in correct use of ELLIPTA DPI at Visit 1 following which participants were assessed on their ability to use the ELLIPTA DPI without guidance from the HCP or parent/guardian. The participants were given a maximum of five attempts. Participants who were unable to use the ELLIPTA DPI correctly were trained by the HCP for the first three attempts. For the fourth and fifth attempts, the participants' parent/guardian assisted in the training of the ELLIPTA DPI. Percentage number of participants who demonstrated correct use of the ELLIPTA DPI along with 95% CI at Visit 1 (attempts 1 to 5) has been presented. The 95% CI for the percentages are calculated using the exact binomial distribution.|Day 1|ITT Population.|||Percentage of participants||95% Confidence Interval|Number
2528867|NCT03478657|Primary|Percentage of Participants Who Rated the ELLIPTA DPI as Easy to Use Among Those Who Could Demonstrate Correct Use at Visit 2, Attempt 1 (Day 28)|"Participants were trained in the correct use of ELLIPTA DPI at Visit 1 by the HCP and eligible participants were required to take one inhalation of placebo from the ELLIPTA DPI once daily for 28 days. At Day 28 (Visit 2), participants were administered a questionnaire on the ease of use of ELLIPTA DPI. For participants in Stratum 1, questionnaire was provided to the interviewer and responses were recorded. For Stratum 2, the questionnaire was self-administered (or interviewer administered, if participant was unable to self-administer). Percentage of participants who rated the ELLIPTA DPI as easy to use was calculated as number of participants who rate the ELLIPTA as easy divided by number of participants who demonstrated correct use at Visit 2 (Attempt #1) multiplied by 100. The 95% CI for the percentages are calculated using the exact binomial distribution."|At Day 28|MITT Population. Only those participants who demostrated correct use at Visit 2, attempt 1 has been analyzed.|||Percentage of participants||95% Confidence Interval|Number
2528868|NCT03478657|Primary|Percentage of Participants From Each Stratum Who Demonstrated Correct Use of the ELLIPTA DPI at Visit 2, Attempt 1 (Day 28)|"Participants were trained in the correct use of ELLIPTA DPI by a healthcare professional (HCP) on Day 1 (Visit 1) following which eligible participants were required to take one inhalation of placebo from the ELLIPTA DPI once daily for 28 days. At Day 28 (Visit 2), participants were administered a questionnaire on ease of use of ELLIPTA DPI. Participants and their parents/guardian were required to complete the questionnaire, following which participants were assessed for their ability to demonstrate correct use of ELLIPTA DPI (1 attempt with no training or instruction and then 1 attempt after instruction from parent/guardian). Percentage of participants who demonstrated correct use of ELLIPTA was calculated as number of participants who demonstrated correct use at Visit 2 divided by number of participants whose use of the ELLIPTA DPI was evaluated at Visit 2 multiplied by 100. The 95% confidence interval (CI) was calculated using the exact binomial distribution."|At Day 28|Modified intent to treat (MITT) Population comprised of all participants who were screened, received at least one dose of the study medication (placebo) and were randomized to a version of the ease of use questionnaire at Visit 2.|||Percentage of participants||95% Confidence Interval|Number
2528885|NCT03476278|Secondary|Mood State According to Preoperative Information|Patients who were given additional preoperative information about regional anesthesia and the things they would encounter during regional anesthesia (ie: they will feel the touches but pain is not expected to be felt, they can feel nausea because of the side-effect of the regional block, what will be done if the regional blocks are unsuccessful and they feel pain,..etc.)|1 day||||Participants|||Count of Participants
2528869|NCT03478644|Secondary|Number of Participants Responses for Consumer Acceptability Questionnaire Score|All the participants supplied with a consumer acceptability questionnaire (Question [Q] 1 to 4) to complete immediately before & after their first use of treatment at home after eating a meal. The number of participants with individual score was reported. After eating & before cleaning denture: Q1= how fresh does denture feel?, Q2= how clean does denture feel?; Look in the mirror and smile, now answer the following questions: Q3= after eating & before cleaning, how clean does denture/smile look ?, Q4= after removing & cleaning denture, how fresh does denture feel?, Q5= after removing & cleaning denture, run your tongue over denture teeth, how clean does denture feel?, Q6= after removing & cleaning denture, how clean does denture/smile look?, Q7= after removing & cleaning denture, how satisfied are you with amount of debris removed? All questions were scored as follows for respective parameter(fresh/clean/satisfied): 0=Not at all, 1=slightly, 2=moderately, 3=very, 4=extremely.|Day 7|Analysis for this outcome was performed on safety population which included all participants who were randomized and received treatment at least once during the study.|||Participants|||Count of Participants
2528870|NCT03478644|Secondary|Proportion of Participants Experiencing Skin Irritation Scores of 2 or Greater After 7 and 14 Days of Use|Dermal assessment performed by a suitably qualified dermatologist on the front and back of the participant's dominant hand (hand with which participant used to hold the wipe during use) using skin irritation score that range from 0-4 as follows: 0 = no apparent cutaneous involvement, 0.5= equivocal reaction, 1= slight erythema with or without oedema, 2= moderate erythema, oedema with or without papules, 3= severe erythema, oedema with or without papules, 4= severe erythema, oedema with vesicles or blisters. Any site where skin irritation was scored ≥2, was visually assessed and reported.|Day 7, Day 14|Analysis for this outcome was performed on safety population which included all participants who were randomized and received treatment at least once during the study.|||Proportion of participants|||Number
2528871|NCT03478644|Primary|Proportion of Participants Experiencing or Reporting Treatment Emergent (TE) Oral Adverse Events (AEs) on or Before 7 Days of Use|Proportion of participants experiencing or reporting TE oral AEs on or before 7 days of use treatments were reported. TE AEs include AEs that were identified during an oral soft tissue examination, a dermal assessment or reported by the subject. AEs were categorized as oral or non-oral by the Clinical Research scientist prior to database lock (oral AE's were AEs effecting tissues associated with the oral cavity extending from the labial mucosa to the pharyngeal area).|up to 7 days|Analysis for this outcome was performed on safety population which included all participants who were randomized and received treatment at least once during the study. No inferential statistical analysis has been performed for this outcome.|||Proportion of participants||95% Confidence Interval|Number
2528872|NCT03478644|Primary|Proportion of Participants Experiencing or Reporting Treatment Emergent (TE) Oral Adverse Events (AEs) on or Before 14 Days of Use|Proportion of participants experiencing or reporting TE oral AEs on or before 14 days of use treatments were reported. TE AEs include AEs that were identified during an oral soft tissue examination, a dermal assessment or reported by the subject. AEs were categorized as oral or non-oral by the Clinical Research scientist prior to database lock (oral AE's were AEs effecting tissues associated with the oral cavity extending from the labial mucosa to the pharyngeal area).|up to 14 days|Analysis for this outcome was performed on safety population which included all the participants who were randomized and received treatment at least once during the study. No inferential statistical analysis has been performed for this outcome.|||Proportion of participants||95% Confidence Interval|Number
2528873|NCT03478371|Secondary|Subject Comfort Questionnaire|Post-menstruation assessment of tampon wear comfort. This assessment uses a 5-point scale which was summarized using the mean as the summary statistic. This questionnaire measured overall satisfaction using a +2 to -2 scale that was converted to a 0 to 100 scale: 100 = excellent rating and 0 = poor rating|4 months|ITT population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one test product and had at least one post-product use measurement.|||units on a scale||Standard Error|Mean
2528874|NCT03478371|Secondary|Subject Comfort Diary|Diary assessment of tampon wear comfort. This assessment uses a 5-point scale which was summarized using the mean as the summary statistic. This questionnaire measured overall comfort using a +2 to -2 scale that was converted to a 0 to 100 scale: 100 = excellent rating and 0 =poor rating|4 months|ITT population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one test product and had at least one post-product use measurement.|||units on a scale||Standard Error|Mean
2528875|NCT03478371|Primary|Vaginal pH|Vaginal pH|within 72 hours last tampon use|ITT population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one test product and had at least one post-product use measurement.|||pH||Standard Error|Mean
2528876|NCT03478371|Primary|Tolerance of Tampon Wear Via Physician Assessment of Vaginal Health|The physician examiner determined tampon tolerance based on the following: 1) Vaginal erythema (0-4 scale), 2) vaginal lacerations (presence or absence), 3) vaginal abrasions (presence or absence), 4) vaginal pH, 5) vaginal discharge|within 72 hours last tampon use|ITT population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one test product and had at least one post-product use measurement.|||Participants|||Count of Participants
2528877|NCT03477903|Secondary|Ctrough: Observed Concentration at the End of a Dosing Interval of TAK-954||Day 5 pre-dose|Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.||||||
2528878|NCT03477903|Secondary|Percentage of Participants Achieving at Least 80% of Daily Goal Protein||Days 1 to 14 or end of treatment|Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.||||||
2528879|NCT03477903|Secondary|Percentage of Participants Achieving at Least 80% of Daily Goal Calories||Days 1 to 14 or end of treatment|Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.||||||
2528880|NCT03477903|Secondary|Time to Resolution of Enteral Feeding Intolerance (EFI)|Time to resolution of EFI is defined as the time needed to achieve GRV less than or equal to 250 ml in the absence of vomiting/retching.|Days 1 to 14 or until resolution of EFI, whichever occurs first|Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.||||||
2528891|NCT03476278|Secondary|Patient Satisfaction According to Preoperative Information|Patients who were given additional preoperative information about regional anesthesia and the things they would encounter during regional anesthesia (ie: they will feel the touches but pain is not expected to be felt, they can feel nausea because of the side-effect of the regional block, what will be done if the regional blocks are unsuccessful and they feel pain,..etc.)|1 day||||Participants|||Count of Participants
2528892|NCT03476278|Secondary|Patient Satisfaction According to Past Regional Anesthesia Experience|patient satisfaction according to past regional anesthesia experience under regional anesthesia|1 day||||Participants|||Count of Participants
2528893|NCT03476278|Secondary|Patient Satisfaction According to the Type of Surgery|patient satisfaction according to the type of surgery under regional anesthesia|1 day||||Participants|||Count of Participants
2528894|NCT03476278|Secondary|Patient Satisfaction According to Education|patient satisfaction from regional anesthesia according to their highest level of education received.|1 day||||Participants|||Count of Participants
2528895|NCT03476278|Secondary|Patient Satisfaction According to Gender|patient satisfaction according to gender under regional anesthesia|1 day||||Participants|||Count of Participants
2528896|NCT03476278|Secondary|Patient Satisfaction According to Age|patient satisfaction according to age under regional anesthesia|1 day (postoperative)||||Participants|||Count of Participants
2528897|NCT03476278|Primary|Overall Mood-state|mood-state of patients during regional anesthesia (patients will be handed a questionnaire about their mood-state in recovery room or in ward. They will be able to mark more than one option about their mood-state: safe, unsafe, comfortable, exited, anxious)|1 day|Patients were able to mark more than one option in the part of the questionnaire about mood-state: safe, unsafe, comfortable, exited, anxious. If patient was heavily sedated and too confused to participate, the questionnaire was handed at the ward after recovery.|||Participants|||Count of Participants
2528898|NCT03476278|Primary|Overall Patient Satisfaction|satisfaction of patients during regional anesthesia (patients will be handed a questionnaire about their satisfaction in recovery room or in ward. They will be able to mark only one option: satisfaction, dissatisfaction)|1 day (peri-operative)||||Participants|||Count of Participants
2528899|NCT03475875|Primary|Overall Vision Score|Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported.|2- Week Follow-up Evaluation|Subjects that completed all study visits without a major protocol deviation.|||Units on a scale||Standard Deviation|Mean
2528900|NCT03475875|Primary|Overall Comfort Score|Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Observations from each study period are treated as independent (for the descriptive summary only). The average of all observations for each lens was reported.|2- Week Follow-up Evaluation|Subjects that completed all study visits without a major protocol deviation.|||Units on a scale||Standard Deviation|Mean
2528901|NCT03474874|Secondary|Sensitization Reactions|"Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction.~Allergic Dermal Sensitization Potential - Erythema will be evaluated at the patch site for only the test material (positive and negative control will not be evaluated). Sensitization reactions will be determined at the patch test site after a two week rest period for each participant (similar to a wash-out period). The patch test site will be tested on the same study subject population, but using a virgin test site."|5 weeks|Only the experimental material (NeoMatriX) was tested for potential sensitization reactions.|||erythema score||Full Range|Mean
2528902|NCT03474874|Primary|Erythema at the Patch Test Site is Evaluated for Each Participant|Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction.|3 weeks||||erythema score||Full Range|Mean
2528903|NCT03474172|Secondary|Compliance of Guardians and Children for Three Continuous PT Therapies|We adopt the VRS-4 to indicate diferent compliance intensities to follow 3 days continuous Tuina therapies as follow:improbable, somewhat improbable, probable, very probable.|The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.||||parents|||Number
2528904|NCT03474172|Secondary|VRS of Parent's Attitude Towards Pediatric Tuina From the Observers' Perspectives|We adopt the VRS-4 to indicate diferent trust intensities of the parents towards pediatric Tuina from the perspective of observers' perspectives as follow: Not confident, somewhat confident, confident, very confident.|The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.||||parents|||Number
2528905|NCT03474172|Secondary|Verbal Rating Scale (VRS) of Children's (≥3 Years Old) Perception of Pediatric Tuina|We adopt the VRS-5 to indicate diferent discomfort intensities towards pediatric Tuina from the perspective of children equal or larger than 3 years old during and after the Tuina as follow: no discomfort; some discomfort; discomfort; very uncomfortable ; uncertain.|The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.||||children|||Number
2528906|NCT03474172|Secondary|Verbal Rating Scale (VRS) of Parent's Attitude Towards Pediatric Tuina|We adopt the VRS-4 to indicate diferent confident intensities towards pediatric Tuina from the perspective of parents as follow: not confident, somewhat confident, confident ,very confident.|The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.||||parents|||Number
2528907|NCT03474172|Primary|The Accuracy Judgement Rates of the Type of Tuina That Children Received Based on Observers' Evaluations|The accuracy judgement rate was calculated from the original data as below and was used as the primary outcome in the study.|The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.||||observers|||Number
2528908|NCT03474172|Primary|The Accuracy Judgement Rates of the Type of Tuina That Children Received Based on Parents' Evaluations|The accuracy judgement rate was calculated from the original data as below and was used as the primary outcome in the study.|The outcome measures started right after the PT therapy was completed and the measurement lasted for 10-15 mins.||||parents|||Number
2528909|NCT03474081|Secondary|Change From Baseline in Pulse Rate|Pulse rate was assessed in the sitting position after approximately 5 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-first-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and Day 84|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2528910|NCT03474081|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were assessed in the sitting position after approximately 5 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-first-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and Day 84|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
2528911|NCT03474081|Secondary|Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other important medical event according to medical or scientific judgement was categorized as SAE.|Up to Day 95|"ITT Population. Non-SAEs and SAEs were presented for all randomized participants excluding one participant in ITT population who was randomized correctly to Tiotropium 18 mcg arm but did not take any randomized study treatment due to withdrawal of consent."|||Participants|||Count of Participants
2528912|NCT03474081|Secondary|Change From Baseline in Trough FEV1 on Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 84 was defined as the average of the two pre-dose FEV1 measurements recorded before the morning dose of randomized study medication on Day 84. Change from Baseline in trough FEV1 on Day 84 was calculated by subtracting Baseline FEV1 value from the trough FEV1 value on Day 84. Baseline FEV1 was defined as the mean of the two assessments made at 30 and 5 minutes pre-dose on Day 1.|Baseline (Day 1 [Pre-dose at 30 minutes and 5 minutes]) and Day 84|ITT Population. Only those participants with data available at the specified time point were analyzed.|||Liters||Standard Error|Least Squares Mean
2528913|NCT03474081|Secondary|Change From Baseline in Trough FEV1 on Day 28|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 28 was defined as the average of the two pre-dose FEV1 measurements recorded before the morning dose of randomized study medication on Day 28. Change from Baseline in trough FEV1 on Day 28 was calculated by subtracting Baseline FEV1 value from the trough FEV1 value on Day 28. Baseline FEV1 was defined as the mean of the two assessments made at 30 and 5 minutes pre-dose on Day 1.|Baseline (Day 1 [Pre-dose at 30 minutes and 5 minutes]) and Day 28|ITT Population. Only those participants with data available at the specified time point were analyzed.|||Liters||Standard Error|Least Squares Mean
2528914|NCT03474081|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 was defined as the mean of the two planned spirometry FEV1 measurements. Change from Baseline in trough FEV1 on Day 85 was calculated by subtracting Baseline FEV1 value from the trough FEV1 value on Day 85. Baseline FEV1 was defined as the mean of the two assessments made at 30 and 5 minutes pre-dose on Day 1.|Baseline (Day 1 [Pre-dose at 30 minutes and 5 minutes]) and Day 85|Intent-To-Treat (ITT) Population comprised of all randomized participants, excluding those who were randomized in error. Only those participants with data available at the specified time point were analyzed.|||Liters||Standard Error|Least Squares Mean
2528915|NCT03473808|Secondary|Mean Change in Hand Motor Function|Change in hand motor function as measured by the Wolf Motor Function Test Time. This test measures time to complete upper extremity movements in seconds. More negative values represent a greater reduction in time, thus better outcomes.|Baseline to approximately 4 weeks after the completion of 18 therapy sessions.||||seconds||Standard Deviation|Mean
2528916|NCT03473808|Secondary|Mean Change in Hand Motor Function|Change in hand motor function as measured by the Wolf Motor Function Test Time. This test measures time to complete upper extremity movements in seconds. More negative values represent a greater reduction in time, thus better outcomes.|Baseline to approximately 1 week after the completion of 18 therapy sessions.||||seconds||Standard Deviation|Mean
2528917|NCT03473808|Primary|Mean Change in Hand Motor Function|Change in hand motor function as measured by the Box and Block Test. The test measures the number of blocks that a participant moves within one minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.|Baseline to approximately 4 weeks after the completion of 18 therapy sessions.||||blocks||Standard Deviation|Mean
2528918|NCT03473808|Primary|Mean Change in Hand Motor Function|Change in hand motor function as measured by the Box and Block Test. The test measures the number of blocks that a participant moves within one minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.|Baseline to approximately 1 week after the completion of 18 therapy sessions.||||blocks||Standard Deviation|Mean
2528919|NCT03473236|Secondary|Pharmacokinetic Analysis of Inhaled GB002: Half-life in Plasma|Measurement of half-life of study drug in plasma after dosing (T1/2)|SAD: from baseline to 48 hours, MAD: from baseline to day 7|Cohorts shown below have a differing number of participants but add up to the overall number of participants seen here|||h||Standard Deviation|Mean
2528920|NCT03473236|Secondary|Pharmacokinetic Analysis of Inhaled GB002: Area Under the Plasma Concentration Versus Time|Measurement of area under the plasma concentration versus time curve (AUC)|SAD: from baseline to 48 hours, MAD: from baseline to day 7|Cohorts shown below have a differing number of participants but add up to the overall number of participants seen here|||h*ng/mL||Standard Deviation|Mean
2549899|NCT02847182|Secondary|Severity of Infusion Reactions|Grade/severity will be assessed according to CTCAE v4.0 guidelines|12 months|||||||
2528921|NCT03473236|Secondary|Pharmacokinetic Analysis of Inhaled GB002: Peak Plasma Concentration|Measurement of peak plasma concentration after dosing (Cmax)|SAD: from baseline to 48 hours, MAD: from baseline to day 7|Cohorts shown below have a differing number of participants but add up to the overall number of participants seen here|||ng/mL||Standard Deviation|Mean
2528922|NCT03473236|Primary|Change From Baseline in White Blood Cell Count|Measurement of white blood cell count|SAD: from baseline to 11 days, MAD: from baseline to 35 days||||10^9 cells/L||Standard Deviation|Mean
2528923|NCT03473236|Primary|Change Form Baseline in Hemoglobin|Measurement of hemoglobin|SAD: from baseline to 11 days, MAD: from baseline to 35 days||||g/dL||Standard Deviation|Mean
2528924|NCT03473236|Primary|Change From Baseline in Kidney Function Parameters|Measurement of BUN and creatinine|SAD: from baseline to 11 days, MAD: from baseline to 35 days||||mg/dL||Standard Deviation|Mean
2528925|NCT03473236|Primary|Change From Baseline in Liver Function Parameters|Measurement of liver function (AST and ALT)|SAD: from baseline to 11 days, MAD: from baseline to 35 days||||U/L||Standard Deviation|Mean
2528926|NCT03473236|Primary|Change From Baseline in Oxygen Saturation|Measurement of oxygen saturation (%)|SAD: from baseline to 11 days, MAD: from baseline to 35 days||||% oxygen saturation||Standard Deviation|Mean
2528927|NCT03473236|Primary|Change From Baseline in Blood Pressure|Measurement of blood pressure (systolic and diastolic in mm Hg)|SAD: from baseline to 11 days, MAD: from baseline to 35 days||||mm Hg||Standard Deviation|Mean
2528928|NCT03473236|Primary|Change From Baseline in Heart Rate|Evaluation of heart rate (beats per minute)|SAD: from baseline to 11 days, MAD: from baseline to 35 days||||beats/min||Standard Deviation|Mean
2528929|NCT03473236|Primary|Change From Baseline in QT Interval|Analysis of 12-lead electrocardiograms (measurement of QT interval)|SAD: from baseline to day 2, 24 hr; MAD: from baseline to day 8, 24 hr||||msec||Standard Deviation|Mean
2528930|NCT03473236|Primary|Change From Baseline in Pulmonary Function Volume Parameters|Pulmonary function measured by spirometry (FEV1, FVC)|SAD: from baseline to 11 days, MAD: from baseline to 35 days||||L||Standard Deviation|Mean
2528931|NCT03473236|Primary|Number of Participants With Treatment-Emergent Adverse Events|Safety As Determined by the Number of Participants with Treatment-Emergent Adverse Events (mild, moderate, severe)|SAD: from baseline to 11 days, MAD: from baseline to 35 days||||Participants|||Count of Participants
2528932|NCT03473197|Primary|Observed Photoallergy (Photosensitization): Number of Skin Sites by Maximum Total Irritation Score|The determination of photosensitization reactions was summarized by frequency counts of the total dermal irritation score during the Challenge Phase. Total Irritation Score is a visual score summing the degree of erythema and edema. Minimum score=0, maximum score=5; higher score=worse outcome|Skin sites evaluated 24, 48, and 72 hours after patch removal and irradiation challenge|The evaluation of photoallergy was based on all subjects who completed the Challenge Phase of the study.|||Number of affected skin sites|skin sites||Number
2528933|NCT03473184|Primary|Observed Phototoxicity|The mean of the total irritation scores 24 and 48 hours post the site irradiation procedure. ( i.e. Day 3 and 4) Total Irritation Score is a visual score summing the degree of erythema and edema. Minimum score= 0; Maximum score = 5; higher score = worse outcome.|Days 3 and 4 (24 and 48 hours post site irradiation procedure)|5 skin sites on each of 34 participants for a total of 170 skin sites evaluated.|||Score on a scale|skin sites|Standard Deviation|Mean
2528934|NCT03473171|Primary|Feasibility as Assessed by Number of Participants Who Had Complications|Complications include respiratory failure, tachypnea, hypercapnia, hypoxemia, air trapping or hyperexpansion.|7 days after starting the RAM cannula||||Participants|||Count of Participants
2528935|NCT03472547|Primary|Observed Sensitization|"The determination of dermal sensitization potential was based on the recurrence of a cutaneous response at re-challenge that was equivalent or more severe than the cumulative irritation score observed during the challenge period.~Cumulative irritation score is a visual score rating the degree of erythema, edema, and other signs of cutaneous irritation: Minimum = 0; Maximum = 6; higher score is worse outcome."|56 days|The evaluation of sensitization was based on all subjects who completed the Challenge Phase of the study.|||Participants with Observed Sensitization|||Number
2528936|NCT03472534|Primary|Skin Irritation Score|"Evaluation of the sum of all subjects' cumulative irritation scores for 21 days at each patch site.~Cumulative Irritation Score is a visual score rating the degree of erythema, edema, and other signs of cutaneous irritation: Minimum = 0; Maximum = 6; higher score is worse outcome."|Daily for 21 days|Per Protocol Population includes all subjects who completed the study with 21 evaluations of irritancy or who discontinued patch sites due to limiting irritation, and was used for analysis of cumulative irritation.|||Normalized cumulative irritation score|Patch sites||Number
2528937|NCT03472287|Primary|Detectable Plasma Concentrations of Diacerein and Rhein|"Bioanalytical analyses were performed to determine concentrations levels of diacerein and rhein in plasma using validated bioanalytical methods.~For Cohort 1, blood samples were taken at pre-dose and 0.5, 1, 2, 3, 4, 6, and 8 hours post-dose.~For Cohort 2, blood samples were taken at pre-dose and 1, 2, 4, 6, and 8 hours post-dose.~Trough PK samples were collected on any 2 available days from Days 3 through 9 for Cohort 1 only.~Summary statistics for each scheduled time were only reported if at least 50% of subjects had quantifiable concentrations."|Days 1-10, at select time points per protocol|Cohort 1: 4 adolescent/adult subjects with EBS, 4 adolescent/adult subjects with DEB; Cohort 2: 3 child subjects with EBS|||Participants|||Count of Participants
2528938|NCT03471975|Primary|Time to Intubation|Time from device passing the mouth until confirmation of tracheal intubation|up to 10 minutes||||second||Full Range|Mean
2528939|NCT03471975|Primary|Intubation Success Rate|tracheal intubation success rate using direct laryngoscope on manikin|up to 10 minutes||||Participants|||Count of Participants
2528940|NCT03471871|Secondary|OSA Cohort: Percentage of Participants With at Least One Incident of SpO2 <90% for at Least 30 Seconds During TST on Day 1 and Day 8 of Treatment|SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.|Day 1 and Day 8|PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter.|||percentage of participant|||Number
2528941|NCT03471871|Secondary|OSA Cohort: Percentage of TST During Which the SpO2 is <90%, 85% and 80 % on Day 1 and Day 8 of Treatment|TST was defined as the total time asleep in minutes using PSG. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.|Day 1 and Day 8|PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. Here, 'number analyzed' signifies participants who were evaluable for analysis at the specified timepoints.|||percentage of TST||Standard Deviation|Mean
2528942|NCT03471871|Secondary|OSA Cohort: SpO2 During TST on Day 1 and Day 8 of Treatment|SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.|Day 1 and Day 8|PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. Here, ‘number analyzed’ signifies participants who were evaluable for analysis at the specified timepoints.|||percentage of oxygen saturation||Standard Deviation|Mean
2528943|NCT03471871|Secondary|HV Cohort: Percentage of Participants With at Least One Incident of SpO2 <90% for at Least 30 Seconds During TST on Day 1 of Treatment|SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using PSG.|Day 1|PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter.|||percentage of participant|||Number
2528944|NCT03471871|Secondary|HV Cohort: Percentage of TST During Which SpO2 Was Less Than (<) 90 Percent (%), 85 % and 80 % on Day 1 of Treatment|TST was defined as the total time asleep in minutes using PSG. SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry.|Day 1|PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter.|||percentage of TST||Standard Deviation|Mean
2528945|NCT03471871|Secondary|OSA Cohort: AHI on Day 1 of Treatment|The AHI is the number of apneas and hypopneas per hour of sleep. AHI less than 5 is considered normal. An AHI from 5 to 14 denotes mild sleep apnea, 15 to 30 is moderate, while a greater than 30 AHI is considered severe.|Day 1|PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.|||events (apnea plus hyponea) per hour||Standard Deviation|Mean
2528946|NCT03471871|Secondary|HV Cohort: AHI on Day 1 of Treatment|The AHI is the number of apneas and hypopneas per hour of sleep. AHI less than 5 is considered normal. An AHI from 5 to 14 denotes mild sleep apnea, 15 to 30 is moderate, while a greater than 30 AHI is considered severe.|Day 1|PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter.|||events (apnea plus hyponea) per hour||Standard Deviation|Mean
2528947|NCT03471871|Primary|OSA Cohort: Apnea-Hypopnea Index (AHI) on Day 8 of Treatment|The AHI is the number of apneas and hypopneas per hour of sleep. AHI less than 5 is considered normal. An AHI from 5 to 14 denotes mild sleep apnea, 15 to 30 is moderate, while a greater than 30 AHI is considered severe.|Day 8|PD analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.|||events (apnea plus hyponea) per hour||Standard Deviation|Mean
2528948|NCT03471871|Primary|HV Cohort: Peripheral Oxygen Saturation (SpO2) During Total Sleep Time (TST) on Day 1 of Treatment|SpO2 is an estimate of the amount of oxygen in the blood. It is the percentage of hemoglobin containing oxygen compared to the total amount of hemoglobin in the blood (that is, oxygenated hemoglobin versus oxygenated and non-oxygenated hemoglobin). SpO2 was monitored by noninvasive method known as transmissive pulse oximetry. TST was defined as the total time asleep in minutes using polysomnography (PSG).|Day 1|Pharmacodynamic (PD) analysis set included group of participants who received at least 1 dose of study drug in each treatment periods and who had sufficient PD data to derive at least 1 primary PD parameter.|||percentage of oxygen saturation||Standard Deviation|Mean
2528949|NCT03471832|Secondary|Subjective Lens Preference|Lens preference (stenfilcon A, Either, Neither, narafilcon A)|3 hours|One subject data was excluded as the subjective lens preference was answered only after 3 hours of lens wear.|||Participants|||Count of Participants
2528950|NCT03471832|Secondary|Subjective Lens Preference|Lens preference (stenfilcon A, Either, Neither, narafilcon A)|5 minutes|One subject data was excluded as the subjective lens preference was answered only after 3 hours of lens wear.|||Participants|||Count of Participants
2528951|NCT03471832|Secondary|Subjective Lens Preference|Lens preference (stenfilcon A, Either, Neither, narafilcon A)|Baseline|One subject data was excluded as the subjective lens preference was answered only after 3 hours of lens wear.|||Participants|||Count of Participants
2528952|NCT03471832|Secondary|Edge/Lens Awareness|Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))|3 hours||||units on a scale|Eyes|Standard Deviation|Mean
2528953|NCT03471832|Secondary|Edge/Lens Awareness|Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))|5 minutes||||units on a scale|Eyes|Standard Deviation|Mean
2528954|NCT03471832|Secondary|Edge/Lens Awareness|Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))|Baseline||||units on a scale|Eyes|Standard Deviation|Mean
2549900|NCT02847182|Secondary|Incidence of Infusion Reactions||12 months|||||||
2528957|NCT03471832|Secondary|Stinging/Burning|Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))|Baseline||||units on a scale|Eyes|Standard Deviation|Mean
2528958|NCT03471832|Secondary|Dryness|Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))|3 hours||||units on a scale|Eyes|Standard Deviation|Mean
2528959|NCT03471832|Secondary|Dryness|Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))|5 minutes||||units on a scale|Eyes|Standard Deviation|Mean
2528960|NCT03471832|Secondary|Dryness|Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))|Baseline||||units on a scale|Eyes|Standard Deviation|Mean
2528961|NCT03471832|Secondary|Comfort|Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))|3 hours||||units on a scale|Eyes|Standard Deviation|Mean
2528962|NCT03471832|Secondary|Comfort|Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))|5 Minutes||||units on a scale|Eyes|Standard Deviation|Mean
2528963|NCT03471832|Secondary|Comfort|Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))|Baseline||||units on a scale|Eyes|Standard Deviation|Mean
2528964|NCT03471832|Primary|Investigator Fit Preference|Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)|3hrs||||Participants|||Count of Participants
2528965|NCT03471832|Primary|Investigator Fit Preference|Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)|5 minutes||||Participants|||Count of Participants
2528966|NCT03471832|Primary|Overall Fitting Performance|Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)|3hrs||||number of eyes|Eyes||Number
2528967|NCT03471832|Primary|Overall Fitting Performance|Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)|5 minutes||||number of eyes|Eyes||Number
2528968|NCT03471832|Primary|Lens Lag|Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)|3hrs||||number of eyes|Eyes||Number
2528969|NCT03471832|Primary|Lens Lag|Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)|5 minutes||||number of eyes|Eyes||Number
2528970|NCT03471832|Primary|Corneal Coverage|Does lens cover the cornea: (Yes, No)|3hrs||||number of eyes|Eyes||Number
2528971|NCT03471832|Primary|Corneal Coverage|Does lens cover the cornea: (Yes, No)|5 minutes||||number of eyes|Eyes||Number
2528972|NCT03471832|Primary|Vertical Lens Centration|Centration of lens horizontally: (Grades = Superior, Slightly superior, Centered, Slightly inferior, Inferior)|3hrs||||Count of eyes|Eyes||Number
2528973|NCT03471832|Primary|Vertical Lens Centration|Centration of lens horizontally: (Grades = Superior, Slightly superior, Center, Slightly inferior, Inferior)|5 minutes||||Number of eyes|Eyes||Number
2528974|NCT03471832|Primary|Horizontal Lens Centration|Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)|3hrs||||number of eyes|Eyes||Number
2528975|NCT03471832|Primary|Horizontal Lens Centration|Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)|5 minutes||||Number of eyes|Eyes||Number
2528976|NCT03471832|Primary|Lens Movement|Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)|3hrs||||Number of eyes|Eyes||Number
2528977|NCT03471832|Primary|Lens Movement|Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)|5 minutes||||Number of eyes|Eyes||Number
2528978|NCT03470740|Secondary|SF-36 Quality of Life_Mental Component Scores (MCS)|The Short-form 36 includes one multi-item scale that assesses 8 dimensions of health: physical functioning (PF), social functioning (SF), role limitations because of physical health problems (RP), bodily pain (BP), general mental health (psychological distress and well-being; MH), limitations in usual role activities because of emotional problems (RE), vitality (energy and fatigue; VT), and general health perceptions (GH), was used to assess the quality of life in this study. The original scale using the Likert scoring method, the score is from 1-3 or 1-5. Before the scores are added, we follow the SF-36 manual, adjust each item scored from 0 to 100, with 0 indicating extreme problems and 100 indicating no problems. The mental component scores (MCS) included RE, SF, VT, and MH, then the scores of each sub-question under the Mental Component Scores are summed together, and the range after adjustment from 0 (extreme problems) to 400 (no problems) for the Mental Component Scores.|6 Months||||score on a scale||Standard Deviation|Mean
2528979|NCT03470740|Secondary|Self-management Behaviors|To assess self-management behaviors the researchers developed a joint activity and protection self-management behaviors scale. The scale consists of eight items and ranges from zero for 'never' to four for 'always'. Higher scores indicate a higher level of use of each of the self-management behavior. The range of the score will be 0-32.|6 months||||score on a scale||Standard Deviation|Mean
2528980|NCT03470740|Secondary|Physical Functioning|The 8-item Modified Health Assessment Questionnaire was used to measure the physical functioning for this study. The MHAQ measures eight activities such as dressing and grooming, arising, eating, walking, hygiene, reach grip, and common daily activities. Items are rated from 1 = without difficulty, to 4 = unable to do; a lower score indicates a greater ability to conduct daily activities. The range of the score will be 8-32.|6 months||||score on a scale||Standard Error|Mean
2528981|NCT03470740|Secondary|SF-36 Quality of life_Physical Component Scores|The Short-form 36 includes one multi-item scale that assesses 8 dimensions of health: physical functioning (PF), social functioning (SF), role limitations because of physical health problems (RP), bodily pain (BP), general mental health (psychological distress and well-being; MH), limitations in usual role activities because of emotional problems (RE), vitality (energy and fatigue; VT), and general health perceptions (GH), was used to assess the quality of life in this study. The original scale using the Likert scoring method, the score is from 1-3 or 1-5. Before the scores are added, we follow the SF-36 manual, adjust each item scored from 0 to 100, with 0 indicating extreme problems and 100 indicating no problems. The physical component scores (PCS) included GH, PF, RP, and BP, then the scores of each sub-question under the Physical Component Scores are summed together, and the range after adjustment from 0 (extreme problems) to 400 (no problems) for the Physical Component Scores.|6 months||||score on a scale||Standard Deviation|Mean
2552316|NCT02796092|Secondary|Need for Re-embolization|Scheduled re-embolization due to incomplete occlusion|12 months||||participants|||Number
2528982|NCT03470740|Secondary|Arthritis Self-efficacy- Other|We used the arthritis self-efficacy-other (ASE-OS) to measure RA patients' other symptoms self-efficacy. The ASE-OS used visual analogue scales (0-10), in which 0 means 'very uncertain' and 10 means 'very certain'; a higher score refers to higher self-efficacy. This scale have 6 items, therefore, the score range will be 0-60.|6 months||||score on a scale||Standard Deviation|Mean
2528983|NCT03470740|Secondary|Arthritis Self-efficacy- Pain|We used the arthritis self-efficacy-pain (ASE-pain) to measure RA patients' pain self-efficacy. The ASE-pain used visual analogue scales (0-10), in which 0 means 'very uncertain' and 10 means 'very certain'; a higher score refers to higher self-efficacy. This scale have 5 items, therefore, the score range will be 0-50.|6 months||||score on a scale||Standard Deviation|Mean
2528984|NCT03470740|Primary|Disease Activity|Disease activity was measured using the DAS-28 (Disease Activity Score-28) which evaluated 28 tender and swollen joint counts of rheumatoid arthritis patients. This scale was used to calculate the 28 tender and swollen joint counts. Scores can range from 0 to 9.4. The lower score represent a better RA outcome.|6 months||||score on a scale||Standard Deviation|Mean
2528985|NCT03468920|Secondary|Patient Satisfaction|Patient reported satisfaction with pain control on a scale of 1 (extremely unsatisfied) to 10 (extremely satisfied)|up to 2 days after surgery||||score on a scale||Standard Deviation|Mean
2528986|NCT03468920|Secondary|Length of Stay|Minutes from entering PACU to end of Phase II|through study visit, less than 24 hours||||minutes||Standard Deviation|Mean
2528987|NCT03468920|Secondary|Number of Participants Who Experienced Postoperative Nausea and Vomiting|Did patient experience negative effects of pain medication (postoperative nausea and vomiting)|through study visit, less than 24 hours||||Participants|||Count of Participants
2528988|NCT03468920|Secondary|Number of Participants Who Received Opioid Administration in PACU|Number of Participants who Received Opioid Administration in PACU|through study visit, less than 24 hours||||Participants|||Count of Participants
2528989|NCT03468920|Primary|Patient Reported Pain|Pain measured from 0 (no pain) to 10 (worst pain)|through study visit, less than 24 hours||||score on a scale||Standard Deviation|Mean
2528990|NCT03468543|Primary|Gastric Retention by Magnetic Resonance Imaging (MRI)|Number of Participants with Gastric Retention by Magnetic Resonance Imaging (MRI), as measured after dosing|7 Days|Subjects who completed dosing and at least one MRI assessment after dosing|||Participants|||Count of Participants
2528991|NCT03468179|Secondary|Serum N-acyl-ethanolamides (NAE)|Serum NAE levels at baseline, 30, 60, 90 and 120 minutes|baseline 30, 60, 90 and 120 minutes|5 participants had pre and post NAE levels below the level of detection for reasons that were unclear|||nmol/L||Standard Error|Mean
2528992|NCT03468179|Secondary|Serum NAPE|Serum NAPE Levels at 30, 60, and 90 minutes|30, 60, and 90 minutes||||nmol/L||Standard Deviation|Mean
2528993|NCT03468179|Primary|Change in Serum N-acyl-phosphatidylethanolamine (NAPE)|Change in serum NAPE from baseline to 120 minutes post-oatmeal challenge|Baseline to 120 minutes||||nmol/L||Standard Error|Mean
2528994|NCT03467971|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse event(AE) was defined as any untoward medical occurrence in participants which does not necessarily have causal relationship with treatment. AE was any unfavorable and unintended sign(including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal product, whether/not considered related to medicinal product. A serious adverse event(SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Term TEAE is defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs.|Baseline up to Day 39|The safety population included all participants who received at least 1 dose of the study treatment in either treatment period 1 or treatment period 2.|||Participants|||Count of Participants
2528995|NCT03467971|Secondary|Apparent Total Body Clearance (CL/f) of Metformin and Gliclazide From Plasma|CL/f is defined as apparent total clearance of the drug from plasma after oral administration.|Pre-dose, 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 28.0, 32.0, 48.0, 72.0, 96.0, 120.0, 144.0 and 168.0 hour post-dose|The PK analysis set included all participants who completed the study with adequate study medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||Liters||Standard Deviation|Mean
2528996|NCT03467971|Secondary|Apparent Volume of Distribution (Vz/f) of Metformin and Gliclazide|Vz/f is defined as apparent volume of distribution during terminal phase after non-intravenous administration|Pre-dose, 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 28.0, 32.0, 48.0, 72.0, 96.0, 120.0, 144.0 and 168.0 hour post-dose|The PK analysis set included all participants who completed the study with adequate study medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||Milliliter (mL)||Standard Deviation|Mean
2528997|NCT03467971|Secondary|Elimination Half Life (t1/2) of Metformin and Gliclazide|Elimination Half Life (t1/2) is defined as the time required for the concentration or amount of drug in the body to be reduced by one-half.|Pre-dose, 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 28.0, 32.0, 48.0, 72.0, 96.0, 120.0, 144.0 and 168.0 hour post-dose|The PK analysis set included all participants who completed the study with adequate study medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||Hours||Standard Deviation|Mean
2528998|NCT03467971|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Metformin and Gliclazide|Tmax is defined as the time to reach maximum plasma concentration.|Pre-dose, 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 28.0, 32.0, 48.0, 72.0, 96.0, 120.0, 144.0 and 168.0 hour post-dose|The PK analysis set included all participants who completed the study with adequate study medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||Hours||Standard Deviation|Mean
2529065|NCT03462927|Primary|Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate|Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Betamethasone Dipropionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose|Week 4|9 subjects were excluded from the PK evaluation at Week 4: 5 in the MC2-01 cream group and 4 in the active comparator group|||pg/mL||95% Confidence Interval|Geometric Mean
2528999|NCT03467971|Primary|Maximum Observed Plasma Concentration (Cmax) of Metformin and Gliclazide|Cmax is defined as the maximum observed plasma concentration.|Pre-dose, 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 28.0, 32.0, 48.0, 72.0, 96.0, 120.0, 144.0 and 168.0 hour post-dose|PK analysis set included all participants who completed the study with adequate study medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||ng/mL||Standard Deviation|Mean
2529000|NCT03467971|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Metformin and Gliclazide|AUC (0-t) is defined as the area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)|Pre-dose, 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 28.0, 32.0, 48.0, 72.0, 96.0, 120.0, 144.0 and 168.0 hour post-dose|PK analysis set included all participants who completed the study with adequate study medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||ng*h/mL||Standard Deviation|Mean
2529001|NCT03467971|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Metformin and Gliclazide|AUC (0-inf) is defined as the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).|Pre-dose, 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24.0, 28.0, 32.0, 48.0, 72.0, 96.0, 120.0, 144.0 and 168.0 hour post-dose|The Pharmacokinetics (PK) analysis set included all participants who completed the study with adequate study medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||Nanogram*hour per milliliter (ng*h/mL)||Standard Deviation|Mean
2529002|NCT03467945|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. TEAEs included both Serious TEAEs and non-serious TEAEs.|Baseline up to Day 72|The safety population included all participants who received at least 1 dose of the trial treatment.|||Participants|||Count of Participants
2529003|NCT03467945|Secondary|Median Residence Time (MRT) for Gliclazide|MRT is the average time that the molecules introduced into the body stays in the body.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose|The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||Hours||Standard Deviation|Mean
2529004|NCT03467945|Secondary|Median Residence Time (MRT) for Metformin|MRT is the average time that the molecules introduced into the body stays in the body.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose|The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||Hours||Standard Deviation|Mean
2529005|NCT03467945|Secondary|Apparent Total Body Clearance (CL/f) of Gliclazide|CL/f was defined as apparent total clearance of the drug from plasma after oral administration.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose|The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||mL/h||Standard Deviation|Mean
2529006|NCT03467945|Secondary|Apparent Total Body Clearance (CL/f) of Metformin|CL/f was defined as apparent total clearance of the drug from plasma after oral administration.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose|The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||Milliliter per Hour (mL/ h)||Standard Deviation|Mean
2529007|NCT03467945|Secondary|Elimination Half Life (t1/2) of Gliclazide|Elimination Half Life (t1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose|The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||Hours||Standard Deviation|Mean
2529008|NCT03467945|Secondary|Elimination Half Life (t1/2) of Metformin|Elimination Half Life (t1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose|The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||Hours||Standard Deviation|Mean
2529009|NCT03467945|Secondary|Apparent Volume of Distribution (Vz/f) of Gliclazide|Vz/f was defined as apparent volume of distribution during terminal phase after non-intravenous administration.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose|The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||Milliliter||Standard Deviation|Mean
2529010|NCT03467945|Secondary|Apparent Volume of Distribution (Vz/f) of Metformin|Vz/f was defined as apparent volume of distribution during terminal phase after non-intravenous administration.|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose|The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||Milliliter||Standard Deviation|Mean
2529011|NCT03467945|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Gliclazide|AUC (0-inf) is defined as the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose|The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||ng*h/ml||Standard Deviation|Mean
2529012|NCT03467945|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Metformin|AUC (0-inf) is defined as the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).|Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose|The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||ng*h/ml||Standard Deviation|Mean
2529013|NCT03467945|Primary|Maximum Observed Plasma Concentration (Cmax) of Gliclazide||Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose|The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||ng/ml||Standard Deviation|Mean
2529014|NCT03467945|Primary|Maximum Observed Plasma Concentration (Cmax) of Metformin||Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose|The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||nanogram per milliliter (ng/ml)||Standard Deviation|Mean
2529015|NCT03467945|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Gliclazide||Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose|The PK analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||ng.h/ml||Standard Deviation|Mean
2529016|NCT03467945|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Metformin||Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 28, 32, 48, 72, 96, 120, 144 and 168 hours post-dose|The Pharmacokinetic (PK) analysis set included all participants who completed the trial with adequate trial medication compliance, without any relevant protocol violations with respect to factors likely to affect the comparability of PK results.|||nanogram*hour per milliliter (ng*h/ml)||Standard Deviation|Mean
2529017|NCT03466658|Primary|Presence of Propionibacterium Acnes in Skin Biopsies During Surgery|The primary outcome measures the intraoperative culture results (e.g. positive vs negative, days to positive conversion) for P. acnes by evaluating bacterial cultures from punch skin biopsies at the time of the surgery.|7 days post-biopsy|Data not analyzed due to unexpected culture contamination.||||||
2529018|NCT03466086|Secondary|Subjective Dryness Rating|Subjective dryness was assessed using Ocular Surface Disease Index (OSDI©) instrument. Dryness is evaluated on a scale of 0 to 100, where higher scores indicate more symptoms of dryness|1-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||Units on a Scale||Standard Deviation|Mean
2529019|NCT03466086|Primary|Ocular Comfort|Ocular comfort was measured using the visual analogue scale of 0 to 100. Where 0 is extremely uncomfortable and 100 is extremely comfortable.|1-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||Units on a scale|eyes|Standard Deviation|Mean
2529020|NCT03466073|Other Pre-specified|Baseline and Sequential Severity Scores|CURB-65 (a 5 point score in which 1 point is allocated to the presence of each of the following: Confusion, Urea >7 mmol/L, Respiratory rate ≥30 breaths min, Blood pressure systolic <90 mmHg or diastolic ≤60 mmHg, and age ≥65 years); PSI (Pneumonia Severity Index, used to predict risk of morbidity and mortality and is classified in risk classes ranging from I to V from the lowest to highest risk as follows: Class I: PSI 0, class II: PSI 1-70, class III: PSI 71-90, class IV: PSI 91-130, class V: PSI >130); SOFA (Sequential Organ Failure Assessment, measured based on 6 variables each representing an organ system scored from 0 to 4 each (normal to severe organ dysfunction/failure), and reported as the sum (range 0-24))|Days 0-28|Results are reported for the combined multiple rhu-pGSN vs. the placebo recipients with available data. One of the placebo recipients in the MAD phase died before dose completion. Since the changes were small across dosing groups, we combined the multi-dose arm in the analysis|||unitless||Full Range|Median
2529021|NCT03466073|Other Pre-specified|Number of Participants With Anti-pGSN Antibodies (Immunogenicity) at the End of Study (Day 28)|Number of participants who developed antibodies against pGSN at study day 28. Patients were first tested against less stringent screening criteria: if screen-positive, a stricter confirmatory test was performed; if screen-negative, no further immunogenicity testing was done.|Day 28|In this analysis, participants receiving single or multiple doses are reported separately.|||Participants|||Count of Participants
2529022|NCT03466073|Secondary|Pharmacokinetics (PK) (Maximum Observed Rhu-pGSN Plasma Concentration (Cmax))|Maximum observed plasma concentration (Cmax) of rhu-pGSN in a 24 hours period after intravenous administration (estimated by subtracting pre-injection concentrations from the measured concentrations at each time point). For the 6 mg/kg dose, there were 4 evaluable subjects in the single-dose arm and 6 subjects in the multiple-dose arm at this dose, for a total of 10 evaluable subjects for Dose 1.|On Days 0-3, specimens were obtained just prior and immediately post dose and 2, 8, 12 and/or 16, and 24 hours post completion of IV administration. In the single-dose arm, only 1 dose was given and thus no data from later days were obtained.|Results from participants given the 6 mg/kg rhu-pGSN dose included 4 subjects in the single-dose arm (samples from 1 subject were lost and 1 subject was withdrawn from the study) and from all 6 patients in the multiple-dose arm given this dose, yielding results from 10 patients for Dose 1.|||µg/mL||Standard Deviation|Mean
2529135|NCT03458871|Primary|"Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item TTNS Did Not Irritate my Skin"|The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.|week 4||||score on a scale||Standard Deviation|Mean
2529023|NCT03466073|Secondary|Pharmacokinetics (PK) (Area Under the Rhu-pGSN Concentration - Time Curve)|Determine AUC 0-t area under the plasma concentration-time curve of rhu-pGSN from 0-24 hours on dosing days (estimated by subtracting pre-injection concentrations from the measured concentrations at each time point). In the single-dose arm, the subject was given only 1 dose so that data from later days were not obtained. In the multiple-dose arms, samples were obtained for each of the 3 doses.|On Days 0-3, specimens were obtained just prior and immediately post dose and 2, 8,12 and/or 16 , and 24 hours post completion of IV administration. In the single-dose arm, only 1 dose was given and thus no data from later days were obtained.|Results from participants given the 6 mg/kg rhu-pGSN dose included 4 subjects in the single-dose arm (samples from 1 subject were lost and 1 subject was withdrawn from the study) and from all 6 patients in the multiple-dose arm given this dose, yielding 10 patients for Dose 1. Only 6 patients were studied on Doses 2 and 3.|||µg*h/mL||Standard Deviation|Mean
2529024|NCT03466073|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|Treatment emergent adverse events were all adverse events (AEs) that occurred subsequent to enrollment. The seriousness of adverse events was judged by the site investigator.|0-28 days||||Participants|||Count of Participants
2529025|NCT03466060|Primary|Subject Comfort|Subjective assessment of initial comfort was conducted using Visual Analogue Scale (VAS) of comfort. VAS of comfort consists of a vertical line which represents continuous scale from 0 (extremely uncomfortable) to 100 (extremely comfortable). VAS comfort was measured at 1-min, 5-min, 45-min, and 2-hours post-fit. The average comfort score for each solution was reported. This is a contralateral crossover, subject used the revitalens solution in one eye throughout the entire study therefore there are twice as many observations for revitalens compared to the other solutions.|Up to 2-Hours Post Lens Fitting|All subjects who successfully completed all study visits without a major protocol deviation.|||Units on a scale|Eyes|Standard Deviation|Mean
2529026|NCT03465904|Secondary|Sustained Pain Relief at 24 Hours|The percentage of patients having mild or no headache (Grade 1 or 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.|2-24 hours||||Participants|||Count of Participants
2529027|NCT03465904|Secondary|Sustained Pain Freedom at 24 Hours|The percentage of patients having no headache (Grade 0) at 2 hours, with no use of anti-migraine rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.|24 hours||||Participants|||Count of Participants
2529028|NCT03465904|Secondary|Use of Rescue Medication Between 2 and 24 Hours|The percentage of patients who took anti-migraine rescue medication between 2 and 24 hours after the beginning of the e-TNS session.|2-24 hours||||Participants|||Count of Participants
2529029|NCT03465904|Secondary|Percentage of Patients With Absence of Photophobia, Phonophobia, Nausea, Vomiting at 2 Hours|The percentage of patients with absence of photophobia, phonophobia, nausea, vomiting at 2 hours after the beginning of the e-TNS session.|2 hours||||Participants|||Count of Participants
2529030|NCT03465904|Secondary|Pain Relief at 2 Hours|The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the beginning of the e-TNS session.|2 hours||||Participants|||Count of Participants
2529031|NCT03465904|Primary|Most Bothersome Migraine-associated Symptom Freedom at 2 Hours|The percentage of patients with absence, at 2 hours after the beginning of the e-TNS session, of the most bothersome migraine-associated symptom identified at baseline.|2 hours||||Participants|||Count of Participants
2529032|NCT03465904|Primary|Pain Freedom at 2 Hours|The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session.|2 hours||||Participants|||Count of Participants
2529033|NCT03465436|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan|Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan.|Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose|All randomized participants who received at least 1 dose of lasmiditan.|||hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529034|NCT03465436|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan.|Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose|All randomized participants who received at least 1 dose of lasmiditan.|||nanogram per milliliter||Standard Deviation|Mean
2529035|NCT03465436|Secondary|Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds|ECGs were assessed for morphology abnormalities or changes in QTcf interval greater than 450 milliseconds by a board-certified cardiologist|Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose|All randomized participants who received at least 1 dose of study drug.|||Incidents|||Number
2529036|NCT03465436|Secondary|Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin|Heart rate was determined during ambulatory blood pressure monitoring (ABPM).|Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose|All randomized participants who received at least 1 dose of study drug and have evaluable HR data.|||beats per minute||Standard Deviation|Mean
2529037|NCT03465436|Secondary|Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin|ECGs were used to calculate cardiac intervals. The QRS interval is the time the segment of the ECG that corresponds to depolarization of the ventricles.|Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose|All randomized participants who received at least 1 dose of study drug and have evaluable QRS data.|||milliseconds||Standard Deviation|Mean
2529038|NCT03465436|Secondary|Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin|ECGs were used to calculate cardiac intervals. The RR interval is the time between two R waves.|Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose|All randomized participants who received at least 1 dose of study drug and have evaluable RR interval data.|||milliseconds||Standard Deviation|Mean
2530761|NCT03374189|Secondary|Number of Participants With Port-site Infection|Redness, purulent discharge, tenderness at port-site|3 days post-op and within one months of surgery||||Participants|||Count of Participants
2529039|NCT03465436|Secondary|Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin|The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for participant pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.|Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose|All randomized participants who received at least 1 dose of study drug and have evaluable QTcI data.|||milliseconds||Standard Deviation|Mean
2529040|NCT03465436|Primary|Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and R-R wave (RR), which is the interval between two R waves. PR is the interval between the P wave and the ventricular depolarization wave (QRS) complex.|Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose|All randomized participants who received at least 1 dose of study drug and have evaluable QTcF data.|||milliseconds||Standard Deviation|Mean
2529041|NCT03463512|Secondary|Number of Recovered Subjects as Defined by Global Physician Assessment of Success at the End of Treatment|Globabl physician assessment used 6 scores with a score of 1 or 2 being regarded as treatment success|5 days|full analysis sample|||Participants|||Count of Participants
2529042|NCT03463512|Secondary|Number of Recovered Subjects Per Treatment Group.|Number of recovered subjects per treatment group. Recovery is defined as the evacuation of the first of two consecutive normal stools or no stool within 12 h within treatment period|5 days|full analysis sample|||Participants|||Count of Participants
2529043|NCT03463512|Primary|Duration of Diarrhea (Hours) Between the Start of Treatment Until Last Diarrheal/Watery Stool Before Recovery or End of Study Treatment (Treatment Duration Maximal 5 Days)|"Duration of diarrhea is defined by date and time of the evacuation of the final diarrheal stool derived from the daily diary.~Log-rank test was performed with a p-value < 0.0001"|5 days|full analysis sample|||hours||Standard Deviation|Mean
2529044|NCT03463161|Secondary|Side Effects|Number of patients with side effect. Summary of side effects by type is provided in adverse events section below.|6 months||||Participants|||Count of Participants
2529045|NCT03463161|Secondary|Overall Survival|Number of patients surviving across both study groups.|1 year|Study terminated after two patients were enrolled due to conflict of interest with no further patient follow-up.||||||
2529046|NCT03463161|Secondary|Progression Free Survival|Number of patients that have not had disease worsening across both study groups.|1 year|Study terminated after two patients were enrolled due to conflict of interest with no further patient follow-up.||||||
2529047|NCT03463161|Primary|Response Rate|Rate of clinical disease response (tumor shrinkage) as seen on imaging.|up to 18 months||||Participants|||Count of Participants
2529048|NCT03463031|Secondary|Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Ocular Symptom Score (rTOSS) Over the 14-day Treatment Period.|The Total Ocular Symptom Score (TOSS) will be calculated using the 3 eye-related non-nasal symptoms: itching/burning eyes, tearing/watering eyes, and redness of eyes. The subject will assess and report his/her non-nasal symptoms twice (AM and PM assessments). Scores ranged from 0 (No sign/symptom evident), 1 (Sign/symptom clearly present but minimal awareness; easily tolerated), 2 (Definite awareness of sign/symptom that is bothersome but tolerable) and 3 (Sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping). The Total Ocular Symptom Score (TOSS) ranged from 0 to 9.|Baseline and day 14|The Full Analysis Set (FAS) consisted of all subjects who are randomized and received at least 1 dose of IP and had at least 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Deviation|Mean
2529049|NCT03463031|Secondary|Change From Baseline in the Overall Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score on Day 15 (Visit 4)|The PRQLQ is a validated, disease-specific, quality-of-life (QOL) questionnaire developed to measure the physical, emotional, and social impairments that are experienced by children (aged ≥6 to <12 years) with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation and other symptoms). Subjects recall how they have been during the previous week and respond to each question on a 7-point scale with scores ranging from 6 (extremely bothered), 5 (very bothered), 4 (quite bothered), 3 (somewhat bothered), 2 (bothered a bit), 1 (hardly bothered at all), 0 (not bothered). The Overall PRQLQ score is the mean of all 23 subject-reported responses. The Overall PRQLQ score range from 0 to 6 where 0 represents no impairment and 6 represents maximum impairment.|Baseline and day 15|The Full Analysis Set (FAS) consisted of all subjects who are randomized and received at least 1 dose of IP and had at least 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Deviation|Mean
2529050|NCT03463031|Secondary|Change From Baseline in Average AM and PM Subject-reported 12-hour Instantaneous Total Nasal Symptom Score (iTNSS) Over the 14-day Treatment Period.|The instantaneous Total Nasal Symptom Score (iTNSS) was assessed by instantaneous (ie, an evaluation of the symptom severity just before taking study medication [within 10 minutes]) of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate, causes interference with activities of daily living and/or sleeping). Each of these four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching) of the iTNSS is rated on a scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). The four nasal symptoms of the iTNSS is summed. The total score of the iTNSS ranged from 0 to 12.|Baseline and day 14|The Full Analysis Set (FAS) consisted of all subjects who are randomized and received at least 1 dose of IP and had at least 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Deviation|Mean
2529064|NCT03462927|Primary|Maximum Plasma Concentration (Cmax) of Active Ingredient Betamethasone Dipropionate|Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Betamethasone Dipropionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose|Week 8|As per protocol, only subjects assigned to the MC2-01 cream had samples for PK testing collected at week 8. Only subjects that had a computable value of the PK parameter have been included in the analysis|||pg/mL||95% Confidence Interval|Geometric Mean
2529051|NCT03463031|Primary|Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score ( rTNSS) Over the 14-day Treatment Period|The Reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate, causes interference with activities of daily living and/or sleeping). Each of these four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching) of the rTNSS is rated on a scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). The four nasal symptoms of the rTNSS is summed. The total score of the rTNSS ranged from 0 to 12.|Baseline and day 14|The Full Analysis Set (FAS) consisted of all subjects who are randomized and received at least 1 dose of IP and had at least 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Deviation|Mean
2529052|NCT03462927|Secondary|Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine|Changes from baseline in ratio of urinary calcium to creatinine defined as urinary calcium (mmol)/creatinine (g)|Baseline and week 8|As per protocol, only subjects assigned to the MC2-01 cream were included in the calcium metabolism evaluation. No data were collected from the CAL/BDP Ointment group. 12 subjects in the MC2-01 cream group were excluded from the analysis|||mmol/g||Standard Deviation|Mean
2529053|NCT03462927|Secondary|Calcium Metabolism Evaluation of the Ratio of Urinary Calcium to Creatinine|Changes from baseline in ratio of urinary calcium to creatinine defined as urinary calcium (mmol)/creatinine (g)|Baseline and week 4|As per protocol, only subjects assigned to the MC2-01 cream were included in the calcium metabolism evaluation. No data were collected from the CAL/BDP Ointment group. 8 subjects in the MC2-01 cream group were excluded from the analysis|||mmol/g||Standard Deviation|Mean
2529054|NCT03462927|Secondary|Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion|Changes from baseline of 24-hour urinary calcium excretion [mmol/day]|Baseline and week 8|As per protocol, only subjects assigned to the MC2-01 cream were included in the calcium metabolism evaluation. No data were collected from the CAL/BDP Ointment group. 12 subjects in the MC2-01 cream group were excluded from the analysis|||mmol/day||Standard Deviation|Mean
2529055|NCT03462927|Secondary|Calcium Metabolism Evaluation of 24-hour Urinary Calcium Excretion|Changes from baseline of 24-hour urinary calcium excretion [mmol/day]|Baseline and week 4|As per protocol, only subjects assigned to the MC2-01 cream were included in the calcium metabolism evaluation. No data were collected from the CAL/BDP Ointment group. 8 subjects in the MC2-01 cream group were excluded from the analysis|||mmol/day||Standard Deviation|Mean
2529056|NCT03462927|Secondary|Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium|Changes from baseline in albumin-corrected serum calcium [mmol/L]|Baseline and week 8|As per protocol, only subjects assigned to the MC2-01 cream were included in the calcium metabolism evaluation. No data were collected from the CAL/BDP Ointment group. 6 subjects in the MC2-01 cream group were excluded from the analysis|||mmol/L||Standard Deviation|Mean
2529057|NCT03462927|Secondary|Calcium Metabolism Evaluation in Albumin-corrected Serum Calcium|Changes from baseline of albumin-corrected serum calcium [mmol/L]|Baseline and week 4|As per protocol, only subjects assigned to the MC2-01 cream were included in the calcium metabolism evaluation. No data were collected from the CAL/BDP Ointment group. 5 subjects in the MC2-01 cream group were excluded from the analysis|||mmol/L||Standard Deviation|Mean
2529058|NCT03462927|Secondary|Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 8 Weeks of Treatment|The HPA challenge test were only performed on subjects that were assigned to the MC2-01 cream group. Out of a total of 32 subjects, 5 subjects were excluded from the analysis as they had HPA suppression at baseline|Week 8|The HPA challenge test were only performed on subjects that were assigned to the MC2-01 cream group. No data were collected from the CAL/BDP Ointment group. Out of a total of 32 subjects, 6 subjects were excluded from the analysis; 5 as they had HPA suppression at baseline and 1 who withdrew consent|||Participants|||Count of Participants
2529059|NCT03462927|Secondary|Number of Subjects With Hypothalamic-pituitary-adrenal [HPA] Suppression After 4 Weeks of Treatment|"The HPA axis evaluation is based on an Adrenocorticotropic hormone [ACTH] challenge test, defined by a 30 minutes ACTH stimulated cortisol value. Only subject with no HPA suppression at baseline were included in the analysis.~The outcome measure lists the number of subjects with HPA suppression 30 minutes after ACTH challenge"|Week 4|The HPA challenge test were only performed on subjects that were assigned to the MC2-01 cream group. No data were collected from the CAL/BDP Ointment group. Out of a total of 32 subjects, 5 subjects were excluded from the analysis as they had HPA suppression at baseline|||Participants|||Count of Participants
2529060|NCT03462927|Primary|Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate|Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite Betamethasone 17-propionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose|Week 8|As per protocol, only subjects assigned to the MC2-01 cream had samples for PK testing collected at week 8. Only subjects that had a computable value of the PK parameter have been included in the analysis|||pg/mL||95% Confidence Interval|Geometric Mean
2529061|NCT03462927|Primary|Maximum Plasma Concentration (Cmax) of Metabolite Betamethasone 17-propionate|Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite Betamethasone 17-propionate. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose|Week 4|9 subjects were excluded from the PK evaluation at Week 4: 5 in the MC2-01 cream group and 4 in active comparator group|||pg/mL||95% Confidence Interval|Geometric Mean
2529062|NCT03462927|Primary|Maximum Plasma Concentration (Cmax) of the Metabolite MC1080|Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite MC1080. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose|Week 8|As per protocol, only subjects assigned to the MC2-01 cream had samples for PK testing collected at week 8. Only subjects that had a computable value of the PK parameter have been included in the analysis|||pg/mL||95% Confidence Interval|Geometric Mean
2529063|NCT03462927|Primary|Maximum Plasma Concentration (Cmax) of the Metabolite MC1080|Geometric Mean for Maximum Plasma Concentration [Cmax] for the metabolite MC1080. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose|Week 4|9 subjects were excluded from the PK evaluation at Week 4: 5 in the MC2-01 cream group and 4 in active comparator group|||pg/mL||95% Confidence Interval|Geometric Mean
2529066|NCT03462927|Primary|Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene|Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Calcipotriene. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose|Week 8|As per protocol, only subjects assigned to the MC2-01 cream had samples for PK testing collected at week 8. Only subjects that had a computable value of the PK parameter have been included in the analysis|||pg/mL||95% Confidence Interval|Geometric Mean
2529067|NCT03462927|Primary|Maximum Plasma Concentration (Cmax) of the Active Ingredient Calcipotriene|Geometric Mean for Maximum Plasma Concentration [Cmax] for the active ingredient Calcipotriene. Plasma concentration was measured at the following timepoints: pre-dose, 30 min, 1, 2, 3, 5 and 7 hours post-dose|Week 4|9 subjects were excluded from the PK evaluation at Week 4: 5 in the MC2-01 cream group and 4 in the active comparator group|||pg/mL||95% Confidence Interval|Geometric Mean
2529068|NCT03462745|Primary|First Attempt Success Rates With the AccuVein 300 Device Versus Standard Method||Beginning of venous Cannulation until end of Cannulation, average of 1 min||||Participants|||Count of Participants
2529069|NCT03461757|Secondary|Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-dose|Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relapse was defined as pain level of mild, moderate, or severe after 2 hours up to 48 hours post-dose for the participants who were pain-free at 2 hours post-dose.|From 2 hours up to 48 hours post-dose|The analysis population was performed on mITT participants with pain freedom at 2 hours post-dose.|||percentage of participants||95% Confidence Interval|Number
2529070|NCT03461757|Secondary|Percentage of Participants With Freedom From Nausea at 2 Hours Post-dose|Nausea status was measured as absent or present in the eDiary. Freedom from nausea was defined as nausea absent.|2 hours post-dose|The analysis was performed on mITT participants with nausea present at migraine onset.|||percentage of participants||95% Confidence Interval|Number
2529071|NCT03461757|Secondary|Percentage of Participants With Freedom From Functional Disability at 60 Minutes Post-dose|Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.|60 minutes post-dose|The analysis was performed on mITT participants.|||percentage of participants||95% Confidence Interval|Number
2529072|NCT03461757|Secondary|Percentage of Participants With Pain Relief at 60 Minutes Post-dose|Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild.|60 minutes post-dose|The analysis was performed on mITT participants.|||percentage of participants||95% Confidence Interval|Number
2529073|NCT03461757|Secondary|Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-dose|Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.|From 2 hours up to 48 hours post-dose|The analysis was performed on mITT participants.|||percentage of participants||95% Confidence Interval|Number
2529074|NCT03461757|Secondary|Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-dose|Phonophobia (sensitivity to sound) status was measured as absent or present in the eDiary. Freedom from phonophobia was defined as phonophobia absent.|2 hours post-dose|The analysis was performed on mITT participants with phonophobia present at migraine onset.|||percentage of participants||95% Confidence Interval|Number
2529075|NCT03461757|Secondary|Percentage of Participants With Freedom From Pain at 90 Minutes Post-dose|Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom was defined as pain level of none.|90 minutes post-dose|The analysis was performed on mITT participants.|||percentage of participants||95% Confidence Interval|Number
2529076|NCT03461757|Secondary|Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 90 Minutes Post-dose|MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at onset that was absent post-dose.|90 minutes post dose|The analysis was performed on mITT participants.|||percentage of participants||95% Confidence Interval|Number
2529077|NCT03461757|Secondary|Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-dose|Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain freedom was defined as pain level of none at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.|From 2 hours up to 24 hours post-dose|The analysis was performed on mITT participants.|||percentage of participants||95% Confidence Interval|Number
2529078|NCT03461757|Secondary|Percentage of Participants With Pain Relief at 90 Minutes Post-dose|Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild.|90 minutes post-dose|The analysis was performed on mITT participants.|||percentage of participants||95% Confidence Interval|Number
2529079|NCT03461757|Secondary|Percentage of Participants With Freedom From Functional Disability at 90 Minutes Post-dose|Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.|90 minutes post-dose|The analysis was performed on mITT participants.|||percentage of participants||95% Confidence Interval|Number
2529080|NCT03461757|Secondary|Percentage of Participants With Freedom From Photophobia at 2 Hours Post-dose|Photophobia (sensitivity to light) status was measured as absent or present in the eDiary. Freedom from photophobia was defined as photophobia absent.|2 hours post-dose|The analysis was performed on mITT participants with photophobia present at migraine onset.|||percentage of participants||95% Confidence Interval|Number
2529081|NCT03461757|Secondary|Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 48 Hours Post-dose|Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Sustained freedom from functional disability was defined as normal function at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.|From 2 hours up to 48 hours post-dose|The analysis was performed on mITT participants.|||percentage of participants||95% Confidence Interval|Number
2529082|NCT03461757|Secondary|Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 48 Hours Post-dose|MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Sustained freedom was defined as MBS reported at onset that was absent at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.|From 2 hours up to 48 hours post-dose|The analysis was performed on mITT participants.|||percentage of participants||95% Confidence Interval|Number
2529083|NCT03461757|Secondary|Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-dose|Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 48 hours post-dose with no rescue medication use through 48 hours post-dose.|From 2 hours up to 48 hours post-dose|The analysis was performed on mITT participants.|||percentage of participants||95% Confidence Interval|Number
2529084|NCT03461757|Secondary|Percentage of Participants With Sustained Freedom From Functional Disability From 2 to 24 Hours Post-dose|Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Sustained freedom from functional disability was defined as normal function at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.|From 2 hours up to 24 hours post-dose|The analysis was performed on mITT participants.|||percentage of participants||95% Confidence Interval|Number
2529085|NCT03461757|Secondary|Percentage of Participants With Rescue Medication Use Within 24 Hours Post-dose|Participants who did not experience relief of their migraine headache at the end of 2 hours after dosing with study medication (and after the 2-hour assessments had been completed on the eDiary) were permitted to use the following rescue medications: aspirin, ibuprofen, acetaminophen up to 1000 mg/day (this includes Excedrin Migraine), naproxen (or any other type of nonsteroidal anti-inflammatory drug), antiemetics (e.g., metoclopramide or promethazine), or baclofen. The participant's use of rescue medication was recorded by the participant in a paper diary.|24 hours post-dose|The analysis was performed on mITT participants.|||percentage of participants||95% Confidence Interval|Number
2529086|NCT03461757|Secondary|Percentage of Participants With Sustained Freedom From Most Bothersome Symptom (MBS) From 2 to 24 Hours Post-dose|MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Sustained freedom was defined as MBS reported at onset that was absent at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.|From 2 hours up to 24 hours post-dose|The analysis was performed on mITT participants.|||percentage of participants||95% Confidence Interval|Number
2529087|NCT03461757|Secondary|Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-dose|Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Sustained pain relief was defined as pain level of none or mild at 2 hours up to 24 hours post-dose with no rescue medication use through 24 hours post-dose.|From 2 hours up to 24 hours post-dose|The analysis was performed on mITT participants.|||percentage of participants||95% Confidence Interval|Number
2529088|NCT03461757|Secondary|Percentage of Participants With Freedom From Functional Disability at 2 Hours Post-dose|Functional disability level was assessed in the eDiary on a 4-point scale: normal function, mild impairment, severe impairment, required bed rest. Freedom from functional disability was defined as normal function.|2 hours post-dose|The analysis was performed on mITT participants.|||percentage of participants||95% Confidence Interval|Number
2529089|NCT03461757|Secondary|Percentage of Participants With Pain Relief at 2 Hours Post-dose|Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. Pain relief was defined as pain level of none or mild.|2 hours post-dose|The analysis was performed on mITT participants.|||percentage of participants||95% Confidence Interval|Number
2529090|NCT03461757|Primary|Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-dose|MBS was reported as nausea, photophobia, or phonophobia at migraine onset using the eDiary. Symptom status (absent, present) was assessed post-dose using the eDiary separately for nausea, photophobia, and phonophobia. Freedom from MBS was defined as MBS reported at onset that was absent post-dose.|2 hours post-dose|The analysis was performed on mITT participants.|||percentage of participants||95% Confidence Interval|Number
2529091|NCT03461757|Primary|Percentage of Participants With Freedom From Pain at 2 Hours Post-dose|Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the electronic diary (eDiary). Pain freedom was defined as pain level of none.|2 hours post-dose|The analysis was performed on modified intent to treat (mITT) participants.|||percentage of participants||95% Confidence Interval|Number
2529092|NCT03461705|Secondary|Ability to Advance to the Target Lesion and Measure RFR and iFR|Percentage of technical failure due to the inability to deliver the wire and measure out of total number of all procedures|During procedure|After 5 patients, investigators realized that the standard deviation of the measurements in real life was higher than the calculated difference that could have existed between the two different measurement techniques and therefore did not collect or analyze the data for the 5 subjects (out of a target of 92).||||||
2529093|NCT03461705|Secondary|Measurement Reproducibility for iFR|Reproducibility of iFR will be tested against RFR. Reproducibility will be measured by comparing the measure of iFR (minimal ratio of distal coronary pressure/aortic pressure during the wave-free period of diastole) at time point 1 versus time point 2 against RFR (minimal ratio of distal coronary pressure/aortic pressure) at time point 1 versus time point 2.|During procedure|After 5 patients, investigators realized that the standard deviation of the measurements in real life was higher than the calculated difference that could have existed between the two different measurement techniques and therefore did not collect or analyze the data for the 5 subjects (out of a target of 92).||||||
2529120|NCT03459612|Secondary|Karolinska Sleepiness Scale (KSS) Score|The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness.|24 hours postdose in each dose period|All randomized participants that received at least 1 dose of study drug and had evaluable data.|||units on a scale||Standard Deviation|Mean
2529094|NCT03461705|Secondary|Measurement Reproducibility for RFR|Reproducibility of RFR will be tested against iFR. Reproducibility will be measured by comparing the measure of RFR (minimal ratio of distal coronary pressure/aortic pressure) at time point 1 versus time point 2 against iFR (minimal ratio of distal coronary pressure/aortic pressure during the wave-free period of diastole) at time point 1 versus time point 2.|During procedure|After 5 patients, investigators realized that the standard deviation of the measurements in real life was higher than the calculated difference that could have existed between the two different measurement techniques and therefore did not collect or analyze the data for the 5 subjects (out of a target of 92).||||||
2529095|NCT03461705|Secondary|Pressure Drift of iFR||During procedure|Since only 5 out of 92 were treated, data was not systematically collected and analysis was not performed.||||||
2529096|NCT03461705|Secondary|Pressure Drift of RFR||During procedure|After 5 patients, investigators realized that the standard deviation of the measurements in real life was higher than the calculated difference that could have existed between the two different measurement techniques and therefore did not collect or analyze the data for the 5 subjects (out of a target of 92).||||||
2529097|NCT03461705|Secondary|Lesion Classification (FFR≤/>0.80) by iFR||During procedure|After 5 patients, investigators realized that the standard deviation of the measurements in real life was higher than the calculated difference that could have existed between the two different measurement techniques and therefore did not collect or analyze the data for the 5 subjects (out of a target of 92).||||||
2529098|NCT03461705|Secondary|Lesion Classification (FFR≤/>0.80) by RFR||During procedure|After 5 patients, investigators realized that the standard deviation of the measurements in real life was higher than the calculated difference that could have existed between the two different measurement techniques and therefore did not collect or analyze the data for the 5 subjects (out of a target of 92).||||||
2529099|NCT03461705|Primary|Percentage Agreement Between Mean RFR and iFR Measurements|Mean RFR measurements will be compared against mean iFR measurements to determine if there is an agreement between RFR and iFR for detection of ischemia.|During procedure|After 5 patients, investigators realized that the standard deviation of the measurements in real life was higher than the calculated difference that could have existed between the two different measurement techniques and therefore did not collect or analyze the data for the 5 subjects (out of a target of 92).||||||
2529100|NCT03460990|Secondary|Observed Pre-Dose Concentration (Ctrough) of VX-659, TEZ, TEZ Metabolite (M1-TEZ), and IVA||From Day 1 and Week 4|"Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug in the TC treatment period. Here Number analyzed signifies those participants who were evaluable at specified time points."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2529101|NCT03460990|Secondary|Safety and Tolerability as Assessed Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)||From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to Week 8)|Safety set included all participants who received at least 1 dose of study drug in the TC treatment period.|||participants|||Number
2529102|NCT03460990|Secondary|Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|From Baseline at Week 4|FAS.|||units on a scale||Standard Error|Least Squares Mean
2529103|NCT03460990|Secondary|Absolute Change in Sweat Chloride (SwCl)|Sweat samples were collected using an approved collection device.|From Baseline at Week 4|FAS.|||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
2529104|NCT03460990|Primary|Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|From Baseline at Week 4|Full analysis set (FAS) included all randomized participants who carried the intended CF transmembrane conductance regulator gene (CFTR) allele mutation and received at least 1 dose of study drug in the TC Treatment Period.|||percentage points||Standard Error|Least Squares Mean
2529105|NCT03460899|Secondary|Changes in Coagulation Marker Fibrinogen (g/L)|"Changes in coagulation marker Fibrinogen, measured on a Behring Coagulation System BCS XP Analyzer.~Visit 3, Hyperinsulinaemic/Hypoglycaemic clamp Experiment:~Timepoint 0 (Baseline = PG 100mg/dL [5.5mmol/L]) Timepoint 1 (Hypoglycaemia Plateau 1 = PG 63mg/dL [3.5mmol/L]) Timepoint 2 (Hypoglycaemia Plateau 2 = PG 45mg/dL [2.5mmol/L]) Timepoint 3 (Recovery = PG 100mg/dL [5.5mmol/L]~Follow up 1 (1 Day after the Clamp Experiment) Follow up 2 (7 +/- 1 day after the Clamp Experiment)"|Measurement during different levels of hypoglycaemia as well as 1 and 7 days after the clamp experiment||||g/L||Standard Deviation|Mean
2529106|NCT03460899|Secondary|Markers of Coagulation Plasminogen Activator Inhibitor-1 (ng/mL)|"Effects on coagulation parameter plasminogen activator Inhibitor-1 (PAI-1) measured by Enzyme-linked immunosorbent assays.~Visit 3, Hyperinsulinaemic/Hypoglycaemic clamp Experiment:~Timepoint 0 (Baseline = PG 100mg/dL [5.5mmol/L]) Timepoint 1 (Hypoglycaemia Plateau 1 = PG 63mg/dL [3.5mmol/L]) Timepoint 2 (Hypoglycaemia Plateau 2 = PG 45mg/dL [2.5mmol/L]) Timepoint 3 (Recovery = PG 100mg/dL [5.5mmol/L]~Follow up 1 (1 Day after the Clamp Experiment) Follow up 2 (7 +/- 1 day after the Clamp Experiment)"|Measurement during different levels of hypoglycaemia as well as 1 and 7 days after the clamp experiment||||ng/mL||Standard Deviation|Mean
2529107|NCT03460899|Secondary|Quantification of Platelet Function and Activation PAC1CD62PCD63POS (%)|"Quantification of platelet activation markers by flow cytometry in unstimulated blood samples (CD62P, CD63 and binding of PAC-1) using a BD LSRFortessa flow cytometer.~Hyperinsulinaemic/Hypoglycaemic clamp Experiment:~Timepoint 0 (Baseline = Plasma Glucose 100mg/dL [5.5mmol/L]) Timepoint 1 (Hypoglycaemia Plateau 1 = Plasma Glucose 63mg/dL [3.5mmol/L]) Timepoint 2 (Hypoglycaemia Plateau 2 = Plasma Glucose 45mg/dL [2.5mmol/L]) Timepoint 3 (Recovery = Plasma Glucose 100mg/dL [5.5mmol/L]~Follow up 1 (1 Day after the Clamp Experiment) Follow up 2 (7 +/- 1 day after the Clamp Experiment)"|Measurement during different levels of hypoglycaemia as well as 1 and 7 days after the clamp experiment||||percentage of PAC1CD62PCD63POS||Standard Deviation|Mean
2529134|NCT03458871|Primary|"Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item TTNS Was Not Painful"|The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.|week 4||||score on a scale||Standard Deviation|Mean
2529108|NCT03460899|Primary|Changes in Platelet Activation Marker Adenosin Diphosphate (%)|"Changes in platelet activation measured by light transmittance aggregometry (LTA) on a Chronolog 700 Lumi-Aggregometer based on Adenosin Diphosphate (ADP %) activation.~Visit 3, Hyperinsulinaemic/Hypoglycaemic clamp Experiment:~Timepoint 0 (Baseline = Plasma Glucose 100mg/dL [5.5mmol/L]) Timepoint 1 (Hypoglycaemia Plateau 1 = Plasma Glucose 63mg/dL [3.5mmol/L]) Timepoint 2 (Hypoglycaemia Plateau 2 = Plasma Glucose 45mg/dL [2.5mmol/L]) Timepoint 3 (Recovery = Plasma Glucose 100mg/dL [5.5mmol/L]~Follow up 1 (1 Day after the Clamp Experiment) Follow up 2 (7 +/- 1 day after the Clamp Experiment)"|Measurement during different levels of hypoglycaemia as well as 1 and 7 days after the clamp experiment||||percentage of ADP||Standard Deviation|Mean
2529109|NCT03459794|Secondary|Complete Blood Counts (CBC)|CBCs will be performed before treatment and 24 hrs later|Pre-treatment (0hrs), 24 hours||||Million cells/mL||Standard Error|Mean
2529110|NCT03459794|Primary|Number of Transcripts in PBMC With Statistically Significant Changes From Pre-treatment Levels.|Changes in expression levels of approximately 770 genes involved in innate immunity will be measured in peripheral blood mononuclear cells (PBMC) before and after treatment. The number of transcripts with significant changes is taken from a comparison of the mean levels in each of the groups, not at the individual participant level. No pre-determined threshold was set for the biological significance of these changes.|Pre-treatment, 4 hours and 24 hours post-treatment|Levels of 770 messenger RNAs (mRNAs) were assayed in PBMC isolated from study participants using the Human Nanostring Myeloid cell panel.|||Transcripts signicantly changed from t=0|||Number
2529111|NCT03459794|Primary|The Number of Cytokines Showing Statistically Significant Changes From Pre-treatment Levels Will be Recorded.|Changes in serum levels of a panel of 41 cytokines will be compared to baseline levels using Luminex methods (HCYTOMAG-60K-PX41 kit from EMD Millipore). No pre-specified threshold was set for biological significance, and the number of cytokines showing a statistically significant (p=<0.05) change from time 0 for each group will be reported. The number of cytokines with significant changes is taken from a comparison of the mean levels in each of the groups, not at the level of individual participants.|Pre-treatment, 4 hours and 24 hours post-treatment|Cytokines were measured in sera using the HCYTOMAG-60K-PX41 kit from EMD Millipore. The numbers reported are the number of cytokines with statistically significant changes ( p = <0.05) from pre-treatment levels.|||Cytokines changed from t=0|Cytokines||Number
2529112|NCT03459612|Secondary|PK: Area Under the Concentration Versus Time Curve (AUC) of Lasmiditan to the Last Timepoint (0-tlast)|PK: AUC of Lasmiditan until the last time a concentration is detected.|Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose|All randomized participants who received at least 1 dose of study drug and had evaluable PK data.|||ng*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529113|NCT03459612|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan|PK: Cmax of Lasmiditan|Day 1: Predose, 0.5 hour (hr), 1hr, 1.5hr, 2hr, 3hr, 4hr, 6hr, 8hr, 10 hr, 12hr, 24hr, 36hr, 48hr postdose|All randomized participants who received at least 1 dose of study drug and had evaluable PK data.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529114|NCT03459612|Secondary|Total Number of Collisions|Total collisions are the sum off collisions with other vehicles and off-road crashes. Collision counts also included the number of times that a lane deviation exceeded 4 feet but where no collision occurred ( a crash-likely event).|24 hours postdose in each dose period|All randomized participants who received at least 1 dose of study drug and had evaluable data.|||collisions||Standard Deviation|Mean
2529115|NCT03459612|Secondary|Total Number of Collisions|Total collisions are the sum off collisions with other vehicles and off-road crashes. Collision counts also included the number of times that a lane deviation exceeded 4 feet but where no collision occurred ( a crash-likely event).|12 hours postdose in each dose period|All randomized participants who received at least 1 dose of study drug and had evaluable data.|||collisions||Standard Deviation|Mean
2529116|NCT03459612|Secondary|Total Number of Collisions|Total collisions are the sum off collisions with other vehicles and off-road crashes. Collision counts also included the number of times that a lane deviation exceeded 4 feet but where no collision occurred ( a crash-likely event).|8 hours postdose in each dose period|All randomized participants who received at least 1 dose of study drug and had evaluable data.|||collisions||Standard Deviation|Mean
2529117|NCT03459612|Secondary|Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test|The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. Scores range from 0 (No correct responses). A higher score indicates greater processing speed.|24 hours postdose in each dose period|All randomized participants who received study drug and have evaluable data.|||Correct responses||Standard Deviation|Mean
2529118|NCT03459612|Secondary|Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test|The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. Scores range from 0 (No correct responses). A higher score indicates greater processing speed.|12 hours postdose in each dose period|All randomized participants who received study drug and have evaluable data.|||Correct responses||Standard Deviation|Mean
2529119|NCT03459612|Secondary|Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test|The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. A measure of recall accuracy A higher score indicates greater processing speed|8 hours postdose in each dose period|All randomized participant that received at least 1 dose of study drug and had evaluable data.|||Correct responses||Standard Deviation|Mean
2546640|NCT02918552|Other Pre-specified|Co-morbid Illness|Change in pre and post scores on the Charlson Comorbidity Index|Week 2(pre drug) to Week 10( post drug); approx. 8 weeks|||||||
2529121|NCT03459612|Secondary|Karolinska Sleepiness Scale (KSS) Score|The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness.|12 hours postdose in each dose period|All randomized participants who received at least 1 dose of study drug and had evaluable data.|||units on a scale||Standard Deviation|Mean
2529122|NCT03459612|Secondary|Karolinska Sleepiness Scale (KSS) Score|The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness.|8 hours postdose in each dose period|All randomized participant that received at least 1 dose of study drug and had evaluable data.|||Units on a scale||Standard Deviation|Mean
2529123|NCT03459612|Primary|Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)|"The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane.~LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points."|24 hours post dose in each dose period|All randomized participants who received at least 1 dose of study drug and had evaluable data.|||centimeters||Full Range|Least Squares Mean
2529124|NCT03459612|Primary|Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)|"The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane.~LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points."|12 hours postdose in each dose period|All randomized participants who received at least 1 dose of study drug and had evaluable data.|||centimeters||Full Range|Least Squares Mean
2529125|NCT03459612|Primary|Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)|"The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane.~LS Means were analyzed using a mixed repeated measures model with fixed effects for sequence, period, and treatment, with repeated observations for subjects for each of the driving time points."|8 hours postdose in each dosing period|All randomized participants who received at least 1 dose of study drug and had evaluable data.|||centimeters||Full Range|Least Squares Mean
2529126|NCT03459196|Primary|Incidence of Acute Safety|Defined as the incidence of early-onset predefined primary adverse events within 7 days of the study procedure, including atrio-eophageal fistula, phrenic nerve paralysis , cardiac tamponade/perforation , pulmonary vein stenosis, death, stroke/CVA, major vascular access complication/bleeding , thromboembolism, myocardial infarction, transient ischemic attack. Device or procedure related death, pulmonary vein stenosis and atrio-esophageal fistula that occur beyond 7 days post- procedure were also be deemed primary AEs.|7 days post-procedure|Effectiveness population includes all subjects who have had the investigational device inserted and underwent ablation with the study catheter used in conjunction with QMode+ for pulmonary vein isolation (PVI). Subjects without any QMode+ application for PVI are excluded from the effectiveness population.|||Participants|||Count of Participants
2529127|NCT03459196|Primary|Number of Subjects Achieved Acute Procedural Success|Defined acute procedural success as confirmation of entrance block in all targeted pulmonary veins after adenosine or isoproterenol challenge.|Day 1|Effectiveness population includes all subjects who have had the investigational device inserted and underwent ablation with the study catheter used in conjunction with QMode+ for pulmonary vein isolation (PVI). Subjects without any QMode+ application for PVI are excluded from the effectiveness population.|||Participants|||Count of Participants
2529128|NCT03459131|Secondary|Over-refraction|Over-refraction (amount of additional correction needed to improve visual acuity (VA)) was collected for each eye and measured in diopters (D). Inferential testing was not planned for this endpoint.|Day 1 (Dispense), each product|Safety Analysis Set|||Eyes|Eyes||Count of Units
2529129|NCT03459131|Primary|Subjective Rating of Overall Vision|Overall vision was assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent. Inferential testing was not planned for this primary effectiveness endpoint.|Day 7, each product|Safety Analysis Set|||units on a scale||Standard Deviation|Mean
2529130|NCT03458871|Primary|"Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item Overall, I Would Recommend TTNS for Those With Neurogenic Bladder"|The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.|week 4||||score on a scale||Standard Deviation|Mean
2529131|NCT03458871|Primary|"Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item If TTNS Works as Well as Medications, I Would Switch to TTNS"|The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.|week 4||||score on a scale||Standard Deviation|Mean
2529132|NCT03458871|Primary|"Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item I Enjoyed Using TTNS"|The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.|week 4||||score on a scale||Standard Deviation|Mean
2529133|NCT03458871|Primary|"Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item TTNS Improved my Quality of Life"|The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.|week 4||||score on a scale||Standard Deviation|Mean
2529136|NCT03458871|Primary|"Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item It Was Easy to Remember to Use TTNS"|The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.|week 4||||score on a scale||Standard Deviation|Mean
2529137|NCT03458871|Primary|"Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item It Was Not Embarrassing to Use TTNS"|The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.|week 4||||score on a scale||Standard Deviation|Mean
2529138|NCT03458871|Secondary|Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire|Items on the anticholinergic side effect severity of symptom questionnaire is scored as 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe), with a higher score indicating a worse outcome.|week 4||||score on a scale||Standard Deviation|Mean
2529139|NCT03458871|Secondary|Anticholinergic Side Effect Severity as Assessed by an Anticholinergic Side Effect Severity of Symptom Questionnaire|Items on the anticholinergic side effect severity of symptom questionnaire is scored as 0 (None), 1 (Mild), 2 (Moderate), or 3 (Severe), with a higher score indicating a worse outcome.|week 0||||score on a scale||Standard Deviation|Mean
2529140|NCT03458871|Secondary|Volume of Catheterization|The research assistant will call weekly to capture the written data and monitor progress with the protocol.|week 1, week 2, week 3, week 4|Only 14 of the 16 participants used the bladder diary, which was used to collect this data.|||milliliters||Standard Deviation|Mean
2529141|NCT03458871|Secondary|Number of Catheterizations Per Day|Frequency of catheterization after TTNS. The research assistant will call weekly to capture the written data and monitor progress with the protocol.|week 1, week 2, week 3, week 4|Only 14 of the 16 participants used the bladder diary, which was used to collect this data.|||catherizations per day||Standard Deviation|Mean
2529142|NCT03458871|Secondary|Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey|Total score on the I-QOL survey is reported. The total score ranges from 0 (poor quality of life) to 100 (maximum quality of life), with a higher score indicating a better quality of life.|week 4||||score on a scale||Standard Error|Mean
2529143|NCT03458871|Secondary|Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey|Total score on the I-QOL survey is reported. The total score ranges from 0 (poor quality of life) to 100 (maximum quality of life), with a higher score indicating a better quality of life.|Week 2||||score on a scale||Standard Deviation|Mean
2529144|NCT03458871|Secondary|Quality of Life as Assessed by Score on Incontinence of Quality of Life (I-QOL) Survey|Total score on the I-QOL survey is reported. The total score ranges from 0 (poor quality of life) to 100 (maximum quality of life), with a higher score indicating a better quality of life.|week 0||||score on a scale||Standard Error|Mean
2529145|NCT03458871|Primary|"Overall Satisfaction of Daily Use of TTNS at Home as Assessed by a TTNS Satisfaction Survey - Item TTNS Was Easy to Use"|The TTNS satisfaction survey ranges from 0 (strongly disagree) to 10 (strongly agree), with higher scores indicating greater satisfaction.|week 4||||score on a scale||Standard Deviation|Mean
2529146|NCT03458871|Primary|Overall Satisfaction of Daily Use of TTNS at Home|The research assistant will call weekly to capture the written data and monitor progress with the protocol.|week 3|This data was not collected.||||||
2529147|NCT03458871|Primary|Overall Satisfaction of Daily Use of TTNS at Home|The research assistant will call weekly to capture the written data and monitor progress with the protocol.|week 2|This data was not collected.||||||
2529148|NCT03458871|Primary|Overall Satisfaction of Daily Use of TTNS at Home|The research assistant will call weekly to capture the written data and monitor progress with the protocol.|week 1|This data was not collected.||||||
2529149|NCT03458871|Primary|Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary|The research assistant will call weekly to capture the written data and monitor progress with the protocol.|week 4|Only 14 of the 16 participants used the bladder diary, which was used to collect this data.|||days||Standard Deviation|Mean
2529150|NCT03458871|Primary|Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary|The research assistant will call weekly to capture the written data and monitor progress with the protocol.|week 3|Only 14 of the 16 participants used the bladder diary, which was used to collect this data.|||days||Standard Deviation|Mean
2529151|NCT03458871|Primary|Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary|The research assistant will call weekly to capture the written data and monitor progress with the protocol.|week 2|Only 14 of the 16 participants used the bladder diary, which was used to collect this data.|||days||Standard Deviation|Mean
2529152|NCT03458871|Primary|Compliance as Assessed by Number of Days Per Week TTNS Was Used, as Recorded at Home Daily in Bladder Diary|The research assistant will call weekly to capture the written data and monitor progress with the protocol.|week 1|Only 14 of the 16 participants used the bladder diary, which was used to collect this data.|||days||Standard Deviation|Mean
2529153|NCT03458871|Primary|Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary|Noted on bladder diary will be description of observed changes, including but not limited to pain, fatigue, vision changes, mental status, bowel program changes, and sexual function changes. The research assistant will call weekly to capture the written data and monitor progress with the protocol.|week 4|Only 14 of the 16 participants used the bladder diary, which was used to collect this data.|||number of adverse events|||Number
2529154|NCT03458871|Primary|Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary|Noted on bladder diary will be description of observed changes, including but not limited to pain, fatigue, vision changes, mental status, bowel program changes, and sexual function changes. The research assistant will call weekly to capture the written data and monitor progress with the protocol.|week 3|Only 14 of the 16 participants used the bladder diary, which was used to collect this data.|||number of adverse events|||Number
2529224|NCT03456960|Primary|Study 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Unchanged Aspirin||Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.|||h*ng/mL||Standard Deviation|Geometric Mean
2529155|NCT03458871|Primary|Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary|Noted on bladder diary will be description of observed changes, including but not limited to pain, fatigue, vision changes, mental status, bowel program changes, and sexual function changes. The research assistant will call weekly to capture the written data and monitor progress with the protocol.|week 2|Only 14 of the 16 participants used the bladder diary, which was used to collect this data.|||number of adverse events|||Number
2529156|NCT03458871|Primary|Safety of Using TTNS at Home Daily as Indicated by Number of Adverse Events Recorded in Bladder Diary|Noted on bladder diary will be description of observed changes including but not limited to pain, fatigue, vision changes, mental status, bowel program changes, and sexual function changes. The research assistant will call weekly to capture the written data and monitor progress with the protocol.|week 1|Only 14 of the 16 participants used the bladder diary, which was used to collect this data.|||number of adverse events|||Number
2529157|NCT03458702|Secondary|RPE Assessed Post-Condition|Ratings of perceived exertion (RPE) assessed using Borg's scale of perceived exertion and pain. Scores range from 6-20, with 6 indicating no exertion at all.|Post-Condition, 10 min after completion of YogaFit and Quiet Rest||||score on a scale||Standard Deviation|Mean
2529158|NCT03458702|Primary|High-frequency Band (HFNU) Assessed at Baseline, Post-Condition and Post-Exposure|"A measure of HRV, HFNU, assessed using three electrodes and CardioPro software at baseline (10 min prior to condition), post-condition (10 min after completion of YogaFit and Quiet Rest) and post-exposure (10 min after 30 min of viewing emotional pictures from the International Affective Picture System (IAPS)).~High frequency (HF) is defined as a band ranging from 0.15-0.4 Hz (cycles per s). Low frequency (LF) is defined as 0.04-0.15 Hz (cycles per s) or a band ranging from 0.04 Hz to 0.15 Hz. The most common frequency domain parameters include the powers in absolute and relative terms and the normalized power of the HF and LF bands or expressed as normalized units. The formula for n.u. for HF = HF in ms2/LF in ms2 + LF in ms2.~HRV is associated with good health: HFNU and LFNU are negatively correlated."|10 min prior to condition, 10 min after completion of YogaFit and Quiet Rest,10 min after exposure to emotional stimuli||||ratio||Standard Deviation|Mean
2529159|NCT03458702|Primary|Low-frequency Band (LFNU) Assessed at Baseline, Post-Condition and Post-Exposure|"A measure of HRV, LFNU, assessed using three electrodes and CardioPro software at baseline (10 min prior to condition), post-condition (10 min after YogaFit and Quiet Rest) and post-exposure (10 min after 30 min of viewing emotional pictures from the International Affective Picture System (IAPS)).~Low frequency (LF) is defined as 0.04-0.15 Hz (cycles per s) or a band ranging from 0.04 Hz to 0.15 Hz. High frequency (HF) is defined as a band ranging from 0.15-0.4 Hz (cycles per s). The most common frequency domain parameters include the powers in absolute and relative terms and the normalized power of the HF and LF bands or expressed as normalized units.~The formula for n.u. for LF = LF in ms2/LF in ms2 + LF in ms2~HRV is associated with good health: increased LFNU is thought to be beneficial."|10 min prior to condition, 10 min after completion of YogaFit and Quiet Rest,10 min after exposure to emotional stimuli||||ratio||Standard Deviation|Mean
2529160|NCT03458702|Primary|Root Mean Square of Successive Differences (RMSSD) Assessed at Baseline, Post-Condition and Post-Exposure|A measure of HRV, RMSSD, was assessed using three electrodes and CardioPro Infiniti-HRV Analysis Software at baseline (10 min prior to condition), post-condition (10 min after completion of YogaFit and Quiet Rest) and post-exposure (10 min after 30 min of viewing emotional pictures from the International Affective Picture System (IAPS)). HRV is associated with good health: increased RMSSD is thought to be beneficial.|10 min prior to condition, 10 min after completion of YogaFit and Quiet Rest,10 min after exposure to emotional stimuli||||milliseconds||Standard Deviation|Mean
2529161|NCT03458702|Primary|Heart Rate Assessed at Baseline, During Condition, Post-Condition and Post-Exposure|HR in beats per min assessed utilizing three electrodes and ProComp Infiniti Software at baseline (10 min prior to condition), during the condition (30 min of YogaFit and Quiet Rest), post-condition (10 min after YogaFit and Quiet Rest) and post-exposure (10 min after 30 min of viewing emotional pictures from the International Affective Picture System (IAPS)).|10 min prior to condition, 30 min during condition, 10 min after completion of YogaFit and Quiet Rest,10 min after exposure to emotional stimuli||||beats per minute||Standard Deviation|Mean
2529162|NCT03458702|Primary|STAI-Y1 Score Assessed at Baseline, Post-Condition and Post-Exposure|State anxiety (STAI-Y1 score) at baseline ( 10 min prior to condition), post-condition (10 min after completion of YogaFit and Quiet Rest) and post-exposure (10 min after completion of 30 min of viewing emotional pictures from the International Affective Picture System (IAPS)) was measured by Spielberger's 20 question State Anxiety Questionnaire (STAI-YI). Scores range from 20-80, with higher scores indicative of increased state anxiety.|10 min prior to condition, 10 min after completion of YogaFit and Quiet Rest,10 min after exposure to emotional stimuli||||score on a scale||Standard Deviation|Mean
2529163|NCT03457909|Secondary|Degree of Comfort|evaluate patient's degree of comfort throughout the procedure.Patients will be asked to fill in a questionnaire to give scores about degree of comfort throughout the procedure.Overall discomfort was scored on a scale of 0 to 10 (0, no discomfort; 10, the overall discomfort of EGD).|up to 2 weeks||||score on a scale||Full Range|Mean
2529164|NCT03457909|Secondary|Quality Score of Z-line Images|grade (mild, moderate,and severe) of air-bubble and saliva interference on the Z-line view(0, no intraluminal gas bubble; 1, a few gas bubbles, no limitation of interpretation; 2, an increased amount of intraluminal foam/gas bubbles, moderate limitation of visibility; 3, an amount of foam/gas bubbles)|up to 2 weeks||||score on a scale||Full Range|Mean
2529165|NCT03457909|Secondary|Z-line Visualization|Z-line represents the normal esophagogastric junction where the squamous mucosa of the esophagus and columnar mucosa of the stomach meet.We can devide the Z-line into four quadrants under capsule endoscopy. Observing all the four quadrants is considered to be a complete observation of Z-line. In this study,the number of participants with at least two quadrants of Z-line visualized was used to evaluate the Z-line visulization.|up to 2 weeks||||participants|||Number
2529166|NCT03457909|Secondary|Duration of Time Capsule is Within the Esophagus|time from the capsule swallowed to the capsule entering the gastric cardia to examine the stomach|up to 2 weeks||||minutes||Full Range|Median
2529167|NCT03457909|Secondary|Number of DS-MCE Associated Adverse Events|evaluate the safety of DS-MCE.Record any adverse event during the procedure and after the procedure.Patients will be followed up by telephone to inquire about the symptoms of abdominal distention, abdominal pain,vomiting and other discomfort. Follow up to the end of the capsule expulsion.|up to 2 weeks||||adverse events|||Number
2529168|NCT03457909|Primary|Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach|evaluate the feasibility of the novel DS-MCE examination. The successful separation of the capsule and string was evaluated by the capsule entering the stomach and and the string being pulled out.Complete viewing of esophagus and stomach was evaluated by completing the procedure from the capsule being swallowed, the esophagus observed retrograde, to the string being pulled out after separating from the capsule.This primary outcome indicated how many participatns completed the DS-MCE examination successfully.|up to 2 weeks||||Participants|||Count of Participants
2529169|NCT03457727|Secondary|Number of Participants With Laboratory Values of Potential Clinical Concern in Part 2|Hematology parameters included platelet count, RBC Count, hemoglobin, hematocrit, MCV, MCH, %Reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils. Clinical chemistry parameters included potassium aspartate, Aminotransferase(AST)/Serum Glutamic-Oxaloacetic Transaminase (SGOT), total and direct, bilirubin, creatinine sodium alanine, Aminotransferase, (ALT)/ Serum Glutamic-Pyruvic, Transaminase (SGPT), total protein, fasting glucose, calcium, alkaline phosphatase and albumin. Urinalysis included specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick and microscopic examination of urine.|Up to 52 days in Part 2|mITT Population|||Participants|||Count of Participants
2529170|NCT03457727|Secondary|Number of Participants With 12-lead Electrocardiogram (ECG) Values of Potential Clinical Concern in Part 2|Single 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals, and QT interval corrected by Fridericia's formula (QTcF). Number of participants with 12-lead ECG values of potential clinical concern in Part 2 are presented.|Up to 52 days in Part 2|mITT Population|||Participants|||Count of Participants
2529171|NCT03457727|Secondary|Number of Participants With Vital Signs of Potential Clinical Concern in Part 2|Vital signs included systolic and diastolic blood pressure, temperature, respiratory rate and pulse rate were measured with participants in semi-supine position after 5 minutes rest.|Up to 52 days in Part 2|mITT Population|||Participants|||Count of Participants
2529172|NCT03457727|Secondary|Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 2|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to 52 days in Part 2|mITT Population|||Participants|||Count of Participants
2529173|NCT03457727|Secondary|Lag Time Before Observable Concentration (Tlag) of Danirixin for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2|PK population. Only those participants with data available at specified time points were analyzed|||Hours||Geometric Coefficient of Variation|Geometric Mean
2529174|NCT03457727|Secondary|Time to Last Quantifiable Concentration (Tlast) of the Blood Concentration of Danirixin for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2|PK population. Only those participants with data available at specified time points were analyzed|||Hours||Geometric Coefficient of Variation|Geometric Mean
2529175|NCT03457727|Secondary|Terminal Half-life (t1/2) of Danirixin for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2|PK population. Only those participants with data available at specified time points were analyzed|||Hours||Geometric Coefficient of Variation|Geometric Mean
2529176|NCT03457727|Secondary|Time to Maximum Observed Concentration (Tmax) of Danirixin for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2|PK population. Only those participants with data available at specified time points were analyzed|||Hours||Geometric Coefficient of Variation|Geometric Mean
2529177|NCT03457727|Secondary|Maximum Observed Concentration (Cmax) of Danirixin for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2|PK population. Only those participants with data available at specified time points were analyzed|||Nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2529178|NCT03457727|Secondary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC [0-24]) of Danirixin for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2|PK population. Only those participants with data available at specified time points were analyzed|||Hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2529179|NCT03457727|Secondary|Area Under the Concentration-time Curve From Time 0 to t (AUC [0-t]) of Danirixin for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2|PK population. Only those participants with data available at specified time points were analyzed|||Hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2529912|NCT03418064|Primary|Post-blink Movement|Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)|Baseline||||score on a scale||Standard Deviation|Mean
2529180|NCT03457727|Secondary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC [0-inf]) of Danirixin for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 2|PK population. Only those participants with data available at specified time points were analyzed|||Hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2529181|NCT03457727|Secondary|Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) of Danirixin for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1|PK population. Only those participants with data available at specified time points were analyzed|||Hours||Standard Deviation|Mean
2529182|NCT03457727|Secondary|Time to Last Quantifiable Concentration (Tlast) of the Blood Concentration of Danirixin for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1|PK population. Only those participants with data available at specified time points were analyzed|||Hours||Standard Deviation|Mean
2529183|NCT03457727|Secondary|Terminal Half-life (t1/2) of Danirixin for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1|PK population. Only those participants with data available at specified time points were analyzed|||Hours||Geometric Coefficient of Variation|Geometric Mean
2529184|NCT03457727|Secondary|Time to Occurrence of Cmax (Tmax) of Danirixin for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1|PK population. Only those participants with data available at specified time points were analyzed|||Hours||Standard Deviation|Mean
2529185|NCT03457727|Secondary|Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose (AUC [0-24]) of Danirixin for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1|PK population. Only those participants with data available at specified time points were analyzed|||Hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2529186|NCT03457727|Secondary|Area Under the Concentration-time Curve From Time 0 to t (AUC [0-t]) of Danirixin for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1|PK population. Only those participants with data available at specified time points were analyzed|||Hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2529187|NCT03457727|Primary|Number of Participants With Laboratory Values of Potential Clinical Concern in Part 1|Hematology parameters included platelet count, RBC Count, hemoglobin, hematocrit, MCV, MCH, %Reticulocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils. Clinical chemistry parameters included potassium aspartate aminotransferase(AST)/Serum Glutamic-Oxaloacetic Transaminase (SGOT), total and direct bilirubin, creatinine, sodium alanine, aminotransferase, (ALT)/ Serum Glutamic-Pyruvic, Transaminase (SGPT), total protein, fasting glucose, calcium, alkaline phosphatase and albumin. Urinalysis included specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick and microscopic examination of urine.|Up to 29 days in Part 1|mITT Population|||Participants|||Count of Participants
2529188|NCT03457727|Primary|Number of Participants With 12-lead Electrocardiogram (ECG) Values of Potential Clinical Concern in Part 1|Single 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals, and QT interval corrected by Fridericia's formula (QTcF). Number of participants with 12-lead ECG values of potential clinical concern in Part 1 are presented.|Up to 29 days in Part 1|mITT Population|||Participants|||Count of Participants
2529189|NCT03457727|Primary|Number of Participants With Vital Signs of Potential Clinical Concern in Part 1|Vital signs included systolic and diastolic blood pressure, temperature, respiratory rate and pulse rate were measured with participants in semi-supine position after 5 minutes rest.|Up to 29 days in Part 1|mITT Population|||Participants|||Count of Participants
2529190|NCT03457727|Primary|Number of Participants With Any Adverse Event (AE) and Serious Adverse Events (SAEs) in Part 1|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to 29 days in Part 1|Modified Intent-to-treat (mITT) Population includes all randomized participants|||Participants|||Count of Participants
2529191|NCT03457727|Primary|Maximum Observed Concentration (Cmax) of Danirixin for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1|PK population. Only those participants with data available at specified time frame were analyzed|||Nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2529253|NCT03454048|Primary|Gametocyte Prevalence|Number of individuals in each study arm that show prevalence of gametocytes as defined by quantitative reverse-transcriptase PCR (qRT-PCR) for CCp4 (female) and PfMGET (male) mRNA with a threshold of 5 gametocytes/mL for positivity.|up to day 51 after challenge infection||||Participants|||Count of Participants
2529192|NCT03457727|Primary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC [0-inf]) of Danirixin for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the pharmacokinetic (PK) profile of Danirixin. PK parameters were calculated by standard non-compartmental analysis using WinNonlin based on actual sampling times.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in Part 1|PK Population includes all participants for whom a PK sample was obtained and analyzed. Only those participants with data available at specified time frame were analyzed.|||Hours*nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529193|NCT03457636|Secondary|Non-inflammatory Lesion Count|Non-inflammatory lesions here include open and closed comedones. These are counted on the face by the investigator from edge of hairline to mandibular line and lower count indicates less severe disease.|Baseline, Week 4, Week 8, Week 12||||lesion count||Standard Deviation|Median
2529194|NCT03457636|Secondary|Inflammatory Lesion Count|Inflammatory lesions here include papules and pustules on the face from edge of hairline to mandibular line as counted by the Investigator. Lower counts indicate less severe disease.|Baseline, Week 4, Week 8, Week 12||||count of lesions||Standard Deviation|Median
2529195|NCT03457636|Secondary|IGA Score|The percent of subjects who have at least a 2 grade improvement on IGA score|12 weeks||||Participants|||Count of Participants
2529196|NCT03457636|Primary|Investigator Global Assessment (IGA) Score|The IGA is an assessment by the Investigator to assess the severity of the subject's disease wherein 0=Clear Skin, 1=Almost Clear, 2=Mild Severity, 3=Moderate, 4=Severe, 5=Very Severe. Lower score indicate less severe disease.|Baseline, Week 4, Week 8, Week 12||||Participants|||Count of Participants
2529197|NCT03456960|Secondary|Study 2, CLR: Renal Clearance for Unchanged Aspirin and Its Metabolites (Salicylic Acid and Salicyluric Acid)||Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable. Data for CLR of Salicyluric acid was not calculated since the plasma concentration of Salicyluric acid was not measured.|||l/h||Standard Deviation|Mean
2529198|NCT03456960|Secondary|Study 2, Fe(0-24): Fraction of Administered Dose Excreted Into Urine From Time 0 to Time 24 Hours for Unchanged Aspirin and Its Metabolites (Salicylic Acid and Salicyluric Acid)||Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.|||percentage of dose||Standard Deviation|Mean
2529199|NCT03456960|Secondary|Study 2, Ae(0-24): Amount of Drug Excreted in Urine From Time 0 to 24 Hours for Unchanged Aspirin and Its Metabolites (Salicylic Acid and Salicyluric Acid)||Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.|||mcg||Standard Deviation|Mean
2529200|NCT03456960|Secondary|Study 2, CLR: Renal Clearance for TAK-438F and Its Metabolites (M-I, M-II, M-III, and M-IV-Sul)||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.|||liter per hour (l/h)||Standard Deviation|Mean
2529201|NCT03456960|Secondary|Study 2, Fe(0-48): Fraction of Administered Dose Excreted Into Urine From Time 0 to Time 48 Hours for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.|||percentage of dose||Standard Deviation|Mean
2529202|NCT03456960|Secondary|Study 2, Ae(0-48): Amount of Drug Excreted in Urine From Time 0 to 48 Hours for TAK-438F and Its Metabolites (M-I, M-II, M-III, and M-IV-Sul)||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.|||microgram (mcg)||Standard Deviation|Mean
2529203|NCT03456960|Secondary|Study 2, T1/2z: Terminal Disposition Phase Half-life for Unchanged Aspirin and Its Metabolite (Salicylic Acid)||Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.|||hour||Standard Deviation|Mean
2529204|NCT03456960|Secondary|Study 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Unchanged Aspirin and Its Metabolite (Salicylic Acid)||Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.|||hour||Full Range|Median
2529205|NCT03456960|Secondary|Study 2, Cmax: Maximum Observed Plasma Concentration for Unchanged Aspirin and Its Metabolite (Salicylic Acid)||Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|The PK analysis set included all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.|||ng/mL||Standard Deviation|Geometric Mean
2529206|NCT03456960|Secondary|Study 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Unchanged Aspirin and Its Metabolite (Salicylic Acid)||Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.|||h*ng/mL||Standard Deviation|Geometric Mean
2529207|NCT03456960|Secondary|Study 2, AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Over the Dosing Interval for Unchanged Aspirin and Its Metabolite (Salicylic Acid)||Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.|||h*ng/mL||Standard Deviation|Geometric Mean
2529208|NCT03456960|Secondary|Study 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Unchanged Aspirin and Its Metabolite (Salicylic Acid)||Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.|||h*ng/mL||Standard Deviation|Geometric Mean
2529209|NCT03456960|Secondary|Study 2, T1/2z: Terminal Disposition Phase Half-life for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable. The PK analysis set where data at specified time points was available.|||hour||Standard Deviation|Mean
2529210|NCT03456960|Secondary|Study 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.|||hour||Full Range|Median
2529211|NCT03456960|Secondary|Study 2, Cmax: Maximum Observed Plasma Concentration for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.|||ng/mL||Standard Deviation|Geometric Mean
2529212|NCT03456960|Secondary|Study 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.|||h*ng/mL||Standard Deviation|Geometric Mean
2529213|NCT03456960|Secondary|Study 2, AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to Time 48 Hours Over the Dosing Interval for TAK-438F and Its Metabolites (M-I, M-II, M-III and M-IV-Sul)||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.|||h*ng/mL||Standard Deviation|Geometric Mean
2529214|NCT03456960|Secondary|Study 2, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites (M) (M-I, M-II, M-III and M-IV-Sul)||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable. The PK analysis set where data at specified time points was available.|||h*ng/mL||Standard Deviation|Geometric Mean
2529215|NCT03456960|Secondary|Study 1, Lambda (z): Terminal Disposition Phase Rate Constant for Unchanged Aspirin||Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable. The PK analysis set where data at specified time points was available.|||1 per hour||Standard Deviation|Mean
2529216|NCT03456960|Secondary|Study 1, MRT (Infinity,ev): Mean Residence Time From Time 0 to Infinity for Unchanged Aspirin||Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable. The PK analysis set where data at specified time points was available.|||hour||Standard Deviation|Mean
2529217|NCT03456960|Secondary|Study 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Unchanged Aspirin||Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.|||hour||Full Range|Median
2529218|NCT03456960|Secondary|Study 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Unchanged Aspirin||Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable. The PK analysis set where data at specified time points was available.|||h*ng/mL||Standard Deviation|Geometric Mean
2529219|NCT03456960|Secondary|Study 1, Lambda (z): Terminal Disposition Phase Rate Constant for TAK-438F||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable. Samples were not collected for Pivotal Study 1 because sufficient results were available for TAK-438F from the Pilot Study 1.|||1 per hour||Standard Deviation|Mean
2529220|NCT03456960|Secondary|Study 1, MRT (Infinity,ev): Mean Residence Time From Time 0 to Infinity for TAK-438F||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable. Samples were not collected for Pivotal Study 1 because sufficient results were available for TAK-438F from the Pilot Study 1.|||hour||Standard Deviation|Mean
2529221|NCT03456960|Secondary|Study 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable. Samples were not collected for Pivotal Study 1 because sufficient results were available for TAK-438F from the Pilot Study 1.|||hour||Full Range|Median
2529222|NCT03456960|Secondary|Study 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set included all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable. Samples were not collected for Pivotal Study 1 because sufficient results were available for TAK-438F from the Pilot Study 1.|||h*ng/mL||Standard Deviation|Geometric Mean
2529223|NCT03456960|Primary|Study 1, Cmax: Maximum Observed Plasma Concentration for Unchanged Aspirin||Day 1 pre-dose and at multiple time points (up to 12 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable.|||ng/mL||Standard Deviation|Geometric Mean
2529254|NCT03454048|Primary|Frequency of Adverse Events in the CHMI-trans Model|Frequency of adverse events in the CHMI-trans model.|up to day 51 after challenge infection||||Adverse events|||Number
2529225|NCT03456960|Primary|Study 1, Cmax: Maximum Observed Plasma Concentration for TAK-438F||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable. Samples were not collected for Pivotal Study 1 because sufficient results were available for TAK-438F from the Pilot Study 1.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2529226|NCT03456960|Primary|Study 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Free Base of TAK-438 (TAK-438F)||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The pharmacokinetic (PK) analysis set was defined as all participants who received at least one dose of study drug, who had no major protocol deviation, and whose PK data were evaluable. Samples were not collected for Pivotal Study 1 because sufficient results were available for TAK-438F from the Pilot Study 1.|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Geometric Mean
2529227|NCT03456856|Primary|Change From Baseline in Heart Rate (HR) at Day 57|"Summary is based on observed data, and no imputation is used for missing values.~Least-square mean is from the repeated measures model which includes scheduled visits and baseline HR measurement as covariates.~The mean change from baseline in heart rate is compared to -5 beats/min which is observed in the placebo group in the Systolic Heart Failure Treatment with the IF Inhibitor Ivabradine Trial (SHIFT) study ( NCT02441218, PMID 20801500)."|Day1 (baseline), Day 57|Full analysis set which included all enrolled participants.|||beats per minute||Standard Error|Least Squares Mean
2529228|NCT03456427|Secondary|Percentage of Acceptable Mammographic Attributes|To evaluate the percentage of acceptable mammographic attributes for unilateral two-view breast images acquired using Patient-Assisted Compression and Technologist Compression modes.|1 Day||||Participants|||Count of Participants
2529229|NCT03456427|Secondary|Number of Repeat Image Acquisitions|To evaluate the need for repeat image acquisition when using Patient-Assisted Compression and Technologist Compression modes.|1 Day||||Participants|||Count of Participants
2529230|NCT03456427|Primary|Percentage of Acceptable Overall Image Quality|The primary objective is to compare the percentage of acceptable overall image quality in unilateral two-view (CC and MLO) breast images acquired using Patient-Assisted Compression and Technologist Compression modes.|1 Day||||Participants|||Count of Participants
2529231|NCT03456245|Primary|Accuracy of Assessment of Participants' Best Visual Acuity (in Diopters)|"Measurements of participants' best visual acuity as measured by mobile devices compared to gold standard of subjective refraction"|1-2 hours|No difference in the analysis population|||Diopters||95% Confidence Interval|Mean
2529232|NCT03455543|Secondary|Patient Global Impression|Patient Global Impression at 4 Months.|Baseline through 4 months.||||Participants|||Count of Participants
2529233|NCT03455543|Secondary|Patients With 2 Point or 30% Reduction in Pain|Percentage of patients who have either a 2 point or 30% reduction in (pain) NPRS at 4 Months.|Baseline to 4 months||||Participants|||Count of Participants
2529234|NCT03455543|Primary|Change in Pain Intensity|Absolute change in pain intensity as measured by the 11-point, numerical pain rating scale (NPRS) (0-10; where 0=no pain, to 10=worst possible pain).|Baseline through 4 months||||units on a scale||Standard Deviation|Mean
2529235|NCT03455491|Secondary|"The Area Under the Curve Modified Jackson Scale Score During 3-day Therapy"|Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.|From randomization up to 3 days of treatment|FAS population|||Ln(units_on_a_scale*sec)||Standard Deviation|Mean
2529236|NCT03455491|Secondary|Percentage of Patients With Complications|The percentage of patients with complications of influenza/acute viral URI|From the time of randomization up to Day 14|FAS population|||Participants|||Count of Participants
2529237|NCT03455491|Secondary|Time to Body Temperature Normalization|Time to body temperature normalization since treatment initiation, measured in hours (normalization is regarded as setting of body temperature below 37°C without elevation above these values)|From the time of randomization assessed up to Day 14|FAS population|||hours||Standard Deviation|Mean
2529238|NCT03455491|Primary|Time to Sustained Improvement in Clinical Symptoms Based on Modified Jackson Scale for ARVI|"The time before the onset of sustained improvement in clinical symptoms according to the Modified Jackson Scale (no more than 1 point for each symptom), measured in hours from the moment of the first dose of the drug.~Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom."|From the time of randomization up to Day 14|Full Analysis Set (FAS) population|||hours||95% Confidence Interval|Median
2529239|NCT03454581|Secondary|Changes on Levels of Anxiety|Beck anxiety inventory (BAI) is a validated questionnaire with 21 multiple-choice items addressing how much the patient has been bothered by common symptoms of anxiety, at the list in the previous week. Each answer is scored on a scale value of 0 = not at all , 1=Mildly, but it didn't bother me much, 2=Moderately - it wasn't pleasant at times and 3=Severely - it bothered me a lot. We applied the BAI in two moments of the study (baseline and at follow -up= day 90). In each moment the participants were classified using a score calculated by finding the sum of the 21 items. Score of 0-21 = low anxiety, Score of 22-35 = moderate anxiety, Score of 36 and above = high levels of anxiety. We presented the results using only the mean of BAI of participants of each group in that moment. We compared the mean of BAI among the groups (PBM X MT X combined groups- intergroup analysis) in the baseline and follow-up period. In addition, we also analyzed intragroup results comparing the mean of BAI.|0,90 days||||score on a scale||95% Confidence Interval|Mean
2529240|NCT03454581|Secondary|Changes on Mandibular Function|"The changes at mandibular functions can be evaluated using the question 19 of RDC/TMD Axis II. Participants answered 0=No (no limitation due to jaw problem) or 1=Yes (the activity is limited by the jaw problem - worse outcome) to a list of activities that the jaw problem can limit from doing. The mean of all the Yes answers (score 1) for each group in the end of the study (day 90) was calculated and compared to the baseline means."|0, 90 days|To the Analysis of Population, we used the mean and the confidence interval of scores of all participants from each group.|||score on a scale||95% Confidence Interval|Mean
2529913|NCT03418064|Primary|Corneal Coverage|Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)|1 Month||||Participants|||Count of Participants
2529241|NCT03454581|Secondary|Change on Nonspecific Physical Symptoms Without Pain|"RDC/TMD Axis II is also used to provide information on nonspecific physical symptoms without pain. The participants rate the experiences in the past few weeks relative to how usually feels about several symptoms nonrelated to pain as follows: 0 =Not at all; 1= A little bit; 2=Moderately; 3=Quite a bit; 4=Extremely. We divided the participants in no symptoms (Normal =scores 0 to1 at the scale) and moderate/severe symptoms (scale 2 to 4 at the scale) and compared the total number of participants in each classification at the end of the study to the baseline numbers."|0, 90 days||||Participants|||Count of Participants
2529242|NCT03454581|Secondary|Change on Nonspecific Physical Symptoms With Pain|"RDC/TMD Axis II can be used to provide information on nonspecific physical symptoms with pain. The participants rate the experiences in the past few weeks relative to how usually feels about several pain symptoms as follows: 0 =Not at all; 1= A little bit; 2=Moderately; 3=Quite a bit; 4=Extremely. We divided the participants into no symptoms (Normal = scores 0 to1 at the scale) and moderate/severe symptoms (scale 2 to 4 at the scale) and compared the total number of participants in each classification (No symptoms and Moderate/severe symptoms) at the end of the study to the baseline numbers."|0, 90 days||||Participants|||Count of Participants
2529243|NCT03454581|Secondary|Changes on Levels of Depression Symptoms|RDC/TMD Axis II is a validated questionnaire which assess the levels of depression symptoms (LDS). The participants answered 20 questions about how much they have been distressed to several symptoms of depression rating on a scale: 0 =Not at all; 1= A little bit; 2=Moderately; 3=Quite a bit; 4=Extremely. The total number of participants in the end of study, with no depression (scores 0 and 1 on the scale) and with moderate and severe depression (scores 2 to 4 on the scale) was compared to the baseline numbers (day 0).|0,90 days||||Participants|||Count of Participants
2529244|NCT03454581|Secondary|Change on Chronic Pain Grades|"RDC/TMD Axis II includes measures from the Graded Chronic Pain Scale (GCPS). Participants rated on scales from 0 = no pain to 10 = pain as bad as could be their current pain and average and worst facial pain in the past six months. Also, on scales from 0 = no interference to 10 = unable to carry on any activities the degree of facial pain interference with daily activities in the past six months. The mean of the ratings, multiplied by 10, gives information on characteristic pain intensity (CPI) and daily disability. The GCP is based on CPI, number of disability days in the past six months and daily disability score classified as 0 = no pain, I = low CPI and disability, II = high CPI and low pain-related disability, III = moderate CPI and disability, and IV = severe CPI and disability. In this study, the number of participants, at the end of the study, with Low Incapacity (Grades 0 to I) and Higher Incapacity (Grades II to IV) was compared to the baseline numbers."|0,90 days||||Participants|||Count of Participants
2529245|NCT03454581|Secondary|Change at Jaw Movements|"Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I was used to provide information of jaw movements. Using a caliper to assess mandibular range of motion (in millimeters), we measure mouth opening, right and left deviations and protrusion.~This questionnaire was applied at baseline (day 0), end of the treatment (day 28) and follow up (day 90)."|0,28,90 days||||millimeters||95% Confidence Interval|Mean
2529246|NCT03454581|Primary|Change From Baseline in Visual Analogic Scale (VAS) for Pain|"Visual Analogic Score (VAS) is a psychometric scale used to measure subjective characteristics, as pain. Consists of a 100mm horizontal line with descriptors no pain at the initial point (score 0) and worst pain at the end point (score 100). To avoid clustering of scores, numbers or verbal descriptors at intermediate points are not recommended. Patients were asked to place a handwritten mark at one point along the 100mm line that best represents their pain intensity. The scores are recorded in millimeters and determined by the measurements from the initial point of the scale to the patients' mark, using a ruler. Higher scores indicate high levels of pain intensity. In this study, the scores (mm) of pain were recorded at days 7, 14, 21, 28, 60 and 90 and compared to the baseline score (day 0) to evaluate the response to each treatment."|0,7,14,21,28,60,90 days||||millimeters||95% Confidence Interval|Mean
2529247|NCT03454048|Secondary|Number of Participants Infectious for Mosquitoes Through DFA|Prevalence of gametocyte infectiousness for Anopheles mosquitoes through Direct Feeding Assays (Direct Skin Feeding Assay, DFA).|up to day 51 after challenge infection|Data are represented per inoculation method (Cohort A; mosquito bite infection, Cohort B; induced blood stage malaria) and not per study arm (group 1-4) as this better reflects the effects of inoculation route on induction of transmissible gametocytaemia.|||Participants|||Count of Participants
2529248|NCT03454048|Secondary|Gametocyte Sex-ratio|Proportion of male gametocytes|up to day 51 after challenge infection|Data are represented per inoculation method (Cohort A; mosquito bite infection, Cohort B; induced blood stage malaria) and not per study arm (group 1-4) as this better reflects the effects of inoculation route on induction of transmissible gametocytaemia.|||Proportion of male gametocytes||Inter-Quartile Range|Median
2529249|NCT03454048|Secondary|Gametocyte Commitment|The gametocyte commitment rate is estimated by dividing the peak gametocyte by the peak of asexual parasites.|up to day 51 after challenge infection|Data are represented per inoculation method (Cohort A; mosquito bite infection, Cohort B; induced blood stage malaria) and not per study arm (group 1-4) as this better reflects the effects of inoculation route on induction of transmissible gametocytaemia.|||gametocytes/asexual parasite||Full Range|Median
2529250|NCT03454048|Secondary|AUC Gametocytes|The area under the curve of gametocyte density versus time. The median AUC was calculated for both cohorts. Since onset of gametocytaemia differs depending on method of infection a window of 15 days was used to calculate AUC, from the time-point where a minimum of 50% of participants within a cohort had detectable gametocytemia.|up to day 51 after challenge infection|Data are represented per inoculation method (Cohort A; mosquito bite infection, Cohort B; induced blood stage malaria) and not per study arm (group 1-4) as this better reflects the effects of inoculation route on induction of transmissible gametocytaemia.|||(gametocytes*days)/mL||Full Range|Median
2529251|NCT03454048|Secondary|Peak Density Gametocytes|Peak density of gametocytes by qRT-PCR.|up to day 51 after challenge infection||||Gametocytes/mL||Full Range|Median
2529252|NCT03454048|Primary|Magnitude of Adverse Events in the CHMI-trans Model|"symptoms will be ranked as (1) mild, (2) moderate, or (3) severe, depending on their intensity according to the following scale:~Mild (grade 1): awareness of symptoms that are easily tolerated and do not interfere with usual daily activity~Moderate (grade 2): discomfort that interferes with or limits usual daily activity~Severe (grade 3): disabling, with subsequent inability to perform usual daily activity, resulting in absence or required bed rest"|up to day 51 after challenge infection||||Adverse events|||Number
2529255|NCT03453060|Secondary|The Effect of a Single Intravenous Dose of E-WE Thrombin on Generation of Activated Protein C- Protein C Inhibitor Complexes (APC-PCI).|Plasma APC-PCI levels will be measured in ng/mL.|Predose, 0.08, 0.25, 0.5, 1, 2, 4, and 24h post-dose|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||ng/mL||Standard Deviation|Mean
2529256|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Urine Leukocyte Esterase Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.|Leukocyte esterase levels in the urine will be evaluated. Clinically significant changes in urine leukocyte esterase levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529257|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Urine Urobilinogen Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.|Urobilinogen levels in the urine will be evaluated. Clinically significant changes in urine urobilinogen levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529258|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Urine Nitrite Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.|Nitrite levels in the urine will be evaluated. Clinically significant changes in urine nitrite levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529259|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Urine Blood Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.|Blood levels in the urine will be evaluated. Clinically significant changes in urine blood levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529260|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Urine Bilirubin Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.|Bilirubin levels in the urine will be evaluated. Clinically significant changes in urine bilirubin levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529261|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Urine Ketone Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.|Ketone levels in the urine will be evaluated. Clinically significant changes in urine ketone levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529262|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Urine Glucose Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.|Glucose levels in the urine will be evaluated. Clinically significant changes in urine glucose are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529263|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Urine Protein Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.|Protein levels in the urine will be evaluated. Clinically significant changes in protein levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529264|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Urine Specific Gravity, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.|Specific gravity of the urine will be evaluated. Clinically significant changes in specific gravity are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529265|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Urine pH, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel.|pH of the urine will be measured. Clinically significant changes in urine pH are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529266|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Platelet Count, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.|Platelet count will be measured in 10˄3/uL. Clinically significant changes in platelet counts are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529267|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Red Blood Cell Count, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.|Red blood cell count will be measured in 10˄6/uL. Clinically significant changes in red blood cell counts are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529914|NCT03418064|Primary|Corneal Coverage|Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)|Dispense||||Participants|||Count of Participants
2529268|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Differential Leukocyte Counts, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.|Differential leukocyte counts will be measured in %. Clinically significant changes in differential leukocyte counts are determined by the PI or designee.|two days.|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529269|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Total Leukocyte Counts, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.|Total leukocyte counts will be measured in 10˄3/uL. Clinically significant changes in leukocyte counts are determined by the PI or designee.|two days.|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529270|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Hematocrit Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.|Hematocrit levels will be measured in %. Clinically significant changes in hematocrit levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529271|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Hemoglobin Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.|Hemoglobin levels will be measured in g/dL. Clinically significant changes in hemoglobin levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529272|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Creatinine Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.|Creatinine levels will be measured in mg/dL. Clinically significant changes in creatinine levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529273|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Glucose Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.|Blood glucose levels will be measured in mg/dL. Clinically significant changes in blood glucose levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529274|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Bicarbonate Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.|Bicarbonate levels will be measured in mEq/L. Clinically significant changes in bicarbonate levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529275|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Chloride Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.|Chloride levels will be measured in mEq/L. Clinically significant changes in chloride levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529276|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Potassium Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.|Potassium levels will be measured in mEq/L. Clinically significant changes in potassium levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529277|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Sodium Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.|Sodium levels will be measured in mEq/L. Clinically significant changes in sodium levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529278|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Albumin Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.|Albumin levels in the blood will be measured in g/dL. Clinically significant changes in albumin levels are determined by the PI or designee.|two days.|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529279|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Lactate Dehydrogenase (LDH) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.|LDH levels in the blood will be measured in U/L. Clinically significant changes in LDH levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529280|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Alanine Aminotransferase (ALT) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.|ALT levels in the blood will be measured in U/L. Clinically significant changes in ALT levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529281|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Aspartate Aminotransferase (AST) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.|AST levels in the blood will be measured in U/L. Clinically significant changes in AST levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529282|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Alkaline Phosphatase Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.|Alkaline phosphatase levels in the blood will be measured in U/L. Clinically significant changes in alkaline phosphatase levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529283|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Bilirubin (Total and Direct) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.|Bilirubin (total and direct) levels in the blood will be measured in mg/dL. Clinically significant changes in total and direct bilirubin levels are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529284|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Blood Urea Nitrogen Levels (BUN) as Part of a Standard Serum Chemistry Panel, Frequency, and Relation to Treatment Will be Assessed.|BUN levels in the blood will be measured in mg/dL. Clinically significant changes in BUN are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529285|NCT03453060|Primary|The Number of Subjects That Develop Treatment-related Immunogenicity.|Immunogenicity measured by plasma anti-drug antibodies.|one month|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529286|NCT03453060|Primary|The Number of Subjects With Injection Site Reaction and/ or Adverse Events That Are Related to Treatment.|Injection site reaction assessment (pain, tenderness, erythema/ redness, and induration/ swelling.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529287|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Plasma Fibrinogen, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Coagulation Panel.|Plasma fibrinogen levels will be measured in mg/dL. Clinically significant changes in plasma fibrinogen levels are determined by the PI or designee.|one month|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529288|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Thrombin Time, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Coagulation Panel.|Thrombin time will be measured in seconds. Clinically significant changes in thrombin time are determined by the PI or designee.|one month|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529289|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Prothrombin Time, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Coagulation Panel.|Prothrombin time will be measured in seconds. Clinically significant changes in prothrombin time are determined by the PI or designee.|one month|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529290|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Activated Partial Thromboplastin Time (aPTT), Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Coagulation Panel.|Plasma aPTT will be measured in seconds. Clinically significant changes in aPTT are determined by the PI or designee.|one month|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529291|NCT03453060|Primary|The Number of Subjects With Abnormal Electrocardiogram and Frequency and/ or Adverse Events That Are Related to Treatment.|12-lead electrocardiogram measurement. Abnormal electrocardiograms are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529292|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Heart Rate, Frequency, and Relation to Treatment Will be Assessed.|Heart rate will be measured in beats per minute. Clinically significant changes in heart rate are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529293|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Blood Pressure (Systolic and Diastolic), Frequency, and Relation to Treatment Will be Assessed.|Systolic and diastolic blood pressure will be measured in mmHg. Clinically significant changes in systolic and diastolic blood pressure are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529349|NCT03447249|Secondary|Absolute Change in Sweat Chloride|Sweat samples were collected using an approved collection device.|From Baseline at Week 4|FAS.|||mmol/L||Standard Error|Least Squares Mean
2529915|NCT03418064|Primary|Corneal Coverage|Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete)|Baseline||||Participants|||Count of Participants
2529294|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Respiratory Rate, Frequency, and Relation to Treatment Will be Assessed.|Respiratory rate will be measured in breaths per minute. Clinically significant changes in respiratory rate are determined by the PI.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529295|NCT03453060|Primary|The Number of Subjects With Clinically Significant Changes in Body Temperature, Frequency, and Relation to Treatment Will be Assessed.|Body temperature will be measured in degrees Celsius. Clinically significant changes in body temperature are determined by the PI or designee.|two days|Subjects who had received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529296|NCT03453060|Primary|The Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Will be Summarized Using Frequency Counts.|TEAEs will be determined by symptom driven physical examinations that can include assessment of the skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, gastrointestinal system, neurological condition, blood and lymphatic systems, and the musculoskeletal system.|one month|Subjects who received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529297|NCT03452371|Secondary|Use of Other Tobacco Treatment Support|Self-report of all tobacco treatment support received, including support from non-study sources, including the internet, during the 3-month study period.|Three months||||Participants|||Count of Participants
2529298|NCT03452371|Secondary|Mean Fagerstrom Test Score for Nicotine Dependence|Standard validated 6 item instrument for assessing the intensity of addiction to nicotine. The 3 yes/no items are scored from 0 to 1. The 3 multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.|Three months||||scores on a scale||Standard Deviation|Mean
2529299|NCT03452371|Secondary|Number of Participants With Stage of Change for Smoking Cessation|"Based on the Transtheoretical Model by Prochaska & DiClemente. The stages of change are: precontemplation, contemplation, preparation, action, maintenance, and relapse.~Defined as moving from pre-contemplation to contemplation, or contemplation to preparation stage."|Three months||||Participants|||Count of Participants
2529300|NCT03452371|Secondary|Number of Participants With Utilization of Smoking Cessation Medication|self-report use of any smoking cessation medications (e.g. nicotine replacement therapy (NRT) patch, gum, lozenges, varenicline)|Three months||||Participants|||Count of Participants
2529301|NCT03452371|Secondary|Number of Participants With Self-reported Smoking Cessation|Self-report of 7-day point prevalence abstinence|Three months||||Participants|||Count of Participants
2529302|NCT03452371|Primary|Number of Participants With Prescription for an FDA-approved Smoking Cessation Medication|Based on chart review, whether a prescription for an FDA-approved smoking cessation medication was sent to the participants' pharmacy (Y/N)|Three months||||Participants|||Count of Participants
2529303|NCT03452176|Secondary|Change in Pain Level|"Change in NRS pain score (score ranges from 1 to 10 with 1 being No pain and 10 being Worst pain) will be calculated by subtracting the patient's Day 10 pain score (end of treatment) from his or her baseline value."|Baseline, 60 days||||score on a scale||Inter-Quartile Range|Median
2529304|NCT03452176|Secondary|Change in Pain Level|"Change in NRS pain score (score ranges from 1 to 10 with 1 being No pain and 10 being Worst pain) will be calculated by subtracting the patient's Day 10 pain score (end of treatment) from his or her baseline value."|Baseline, 30 days||||score on a scale||Inter-Quartile Range|Median
2529305|NCT03452176|Secondary|Change in Pain Level|"Change in NRS pain score (score ranges from 1 to 10 with 1 being No pain and 10 being Worst pain) will be calculated by subtracting the patient's Day 10 pain score (end of treatment) from his or her baseline value."|Baseline, 10 days|Scrambler pre/post compared to sham pre/post using Wilcoxian signed rank|||score on a scale||Inter-Quartile Range|Median
2529306|NCT03452176|Primary|Feasibility as Assessed by Number of Participants That Completed Treatment Visits|Adherence to visit schedule will be determined by the number of participants that completed the 10 treatment visits.|10 days||||Participants|||Count of Participants
2529307|NCT03452176|Primary|Acceptability as Assessed by the Number of Participants Responding Yes to a Question|"Will be determined by how many participants say yes to the following question, Would you want to continue the treatment if it were available?"|10 days||||Participants|||Count of Participants
2529308|NCT03451721|Primary|the Percentage of Participant That Have the Average LV Sensed Amplitude at the MRI + 1 Month Visit Remains <5.0 mV or Above 50% of the Pre-MR Scan Value|Subjects will be considered a success if the average sensed amplitude at the MRI + 1 Month Visit remains ≥ 5.0 mV and above 50% of the pre-MR scan value, otherwise, it is a primary effectiveness endpoint 5 event.The performance goal of this endpoint for the ENABLE MRI study was 85%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 5 occur.|MR +1 Month visit( 10~14 weeks from 0 day)|only 10 patients implanted with LV leads and underwent the evaluation of LV sensed amplitude. Besides, 9 of them underwent the MR scan.|||percentage of participant||95% Confidence Interval|Number
2529309|NCT03451721|Primary|The Percentage of Participant Have an Increase in Average LV Pacing Thresholds >1.0V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up|Subjects that have an increase in average LV pacing thresholds ≤1.0V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 Month follow-up will be considered a success, otherwise, it is a primary effectiveness endpoint 4 event.The performance goal of this endpoint for the ENABLE MRI study was 87%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 4 occur.|MR +1 Month visit( 10~14 weeks from 0 day)|only 10 patients implanted with LV leads and underwent the evaluation of LV pacing thresholds. Besides, 9 of them underwent the MR scan.|||percentage of participant||95% Confidence Interval|Number
2529350|NCT03447249|Secondary|Absolute Change in Body Mass Index (BMI)|BMI was defined as weight in kilogram (kg) divided by height in square meter (m^2).|From Baseline at Week 24|FAS.|||kilogram per meter square (kg/m^2)||Standard Error|Least Squares Mean
2529310|NCT03451721|Primary|The Percentage of Participant That Have the Average RV Sensed Amplitude at the MRI + 1 Month Visit Remains < 5.0 mV or Less Than 50% of the Pre-MR Scan Value|Subjects will be considered a success if the average sensed amplitude at the MRI + 1 Month Visit remains ≥ 5.0 mV and above 50% of the pre-MR scan value, otherwise, it is a primary effectiveness endpoint 3 event.The performance goal of this endpoint for the ENABLE MRI study was 85%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 3 occur.|MR+1 Month visit( 10~14 weeks from 0 day)|20 patients enrolled.19 of them underwent the MR scan and the evaluation of RV sensed amplitude|||percentage of participant||95% Confidence Interval|Number
2529311|NCT03451721|Primary|The Percentage of Participant That Have an Increase in Average RV Pacing Thresholds > 0.5V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up|Subjects that have an increase in average RV pacing thresholds ≤ 0.5V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 Month follow-up will be considered a success, otherwise, it is a primary effectiveness endpoint 2 event.The performance goal of this endpoint for the ENABLE MRI study was 87%. There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 2 occur.|MRI+1Month visit( 10~14 weeks from 0 day)|20 patients enrolled.19 of them underwent the MR scan and the evaluation of RV pacing thresholds|||percentage of participant||95% Confidence Interval|Number
2529312|NCT03451721|Primary|The Percentage of Participant Whose the Average RV Shocking Impedance is >200 Ohm 1 Month Post Scan, While it is ≤ 200 Ohm Before Scan|The normal RV shocking impedance measured by the system should be≤200 Ohm, with >200 Ohm considered abnormal. The primary effectiveness endpoint 1 is defined as that the average RV shocking impedance is >200 Ohm at 1 month post scan, while it is ≤ 200 Ohm before scan.There is no hypothesis testing in the MR ICD study, and it can be considered reasonable if up to 2 failed cases of primary effectiveness endpoint 1 occur.|MRI+1 Month visit ( 10~13 weeks from 0 day)|20 patients enrolled. 19 attended the MR scan.|||percentage of participant||95% Confidence Interval|Number
2529313|NCT03451721|Primary|The Percent of Participants Who Were MR Scan-Related ImageReady System Complication -Free|The primary safety endpoint of the MR ICD study will be assessed for all subjects who undergo any portion of the study-required MR scan sequences. Safety will be confirmed by evaluating the MR scan related ImageReady System complication-free rate (CFR) between the MR Scan and the MRI Visit + 1 Month.MR scan related ImageReady System complication is relation with ImageReady System and MR Scan.|MRI + 1 Month Visit（10-13 weeks from 0 day）|20 patients enrolled. 19 attended the MR scan.|||percentage of participants||95% Confidence Interval|Number
2529314|NCT03450070|Primary|Number of Participants That Did Not Have Test Material Induced Clinically Significant Dermal Irritation|"Clinically Significant Dermal Irritation refers to an overall outcome measure in which, after 6 weeks of the test (patching the skin (3 weeks) & then challenging the skin (at week 6)), the test product caused a clinically significant dermal reaction (scores of 2 or greater). Participant scores less than 2 are not considered to be Clinically significant.~Scoring System:~0 = No visible reaction~± = Faint, minimal erythema~= Erythema~= Intense erythema~= Intense erythema, induration, vesicles~= Severe reaction with erythema, induration, vesicles, pustules (may be weeping) E = Edema DR = Dryness P = Peeling S = Staining~= Hyperpigmentation / Hypopigmentation C = Change of test site N9R = No 9th reading~= No patch application and / or reading TR = Tape Reaction"|approximately 6 weeks||||Participants|||Count of Participants
2529315|NCT03449433|Secondary|Pharmacodynamics (PD): Change From Baseline Area Under the Concentration Curve of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)|PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)|Time Frame:-30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes postdose|All randomized participants who evaluable PD parameters.|||milligrams times hour per deciliter||Standard Deviation|Mean
2529316|NCT03449433|Primary|Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm|PK: Insulin Lispro or Insulin Aspart AUC(0-7h)|0 (predose), 1, 2, 3,5,10, 15, 20, 25, 30,35, 40, 45, 50, 55,60, 70, 90, 120, 150,180, 240, 300, 360 and 420 minutes postdose|All randomized, T1DM participants who received at least 1 dose of study drug.|||picomols times hour per Liter||Geometric Coefficient of Variation|Geometric Mean
2529317|NCT03449342|Secondary|Incidence of Allergic or Infusion Reactions Related to the Trial Product|Incidence of allergic or infusion reactions related to trial products were calculated as the number of reactions per patient years. Allergic reactions are a class of adverse events related to allergy.|Weeks 0-12|Results are based on the SAS, that included all dosed participants with data after dosing during 8 weeks of treatment.|||Number of reactions per patient years|||Number
2529318|NCT03449342|Secondary|Total Annualised Consumption of Turoctocog Alfa|Total consumption of turoctocog alfa was evaluated during 8 weeks of treatment and it was presented as IU of turoctocog alfa/kg body weight (BW) per year per participant.|Weeks 0-8|Results are based on the FAS that included all dosed participants with data after dosing during 8 weeks of treatment.|||IU/kg BW/year/participant||Standard Deviation|Mean
2529319|NCT03449342|Secondary|Number of Bleeding Episodes With Successful Haemostatic Effect of Turoctocog Alfa|The haemostatic effect (HE) of turoctocog alfa when used for treatment of bleeding episodes was evaluated during 8 weeks of treatment. Successful haemostatic effect means the haemostatic response when used for treatment of a bleeding episode was either excellent or good. Excellent haemostatic respose: Abrupt pain relief and/or clear improvement in objective signs of bleeding episode within approximately 8 hours after a single injection. Good haemostatic response: Definite pain relief and/or improvement in signs of bleeding episode within approximately 8 hours after an injection, but possibly requiring more than 1 injection for complete resolution.|Weeks 0-8|"Results are based on the FAS that included all dosed participants with data after dosing during 8 weeks of treatment. Overall Number of Participants Analyzed = Number of participants with bleeding episodes treated with turoctocog alfa."|||Bleeding episodes with successfull HE|bleeding episodes||Number
2529351|NCT03447249|Secondary|Absolute Change in Cystic Fibrosis Questionnaire Revised (CFQ-R) Respiratory Domain Score|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|From Baseline through Week 24|FAS.|||units on a scale||Standard Error|Least Squares Mean
2529320|NCT03449342|Secondary|Incidence of Adverse Drug Reactions (ARs) and Serious Adverse Reactions (SARs)|Incidence of adverse drug reactions (ARs) and serious adverse reactions (SARs) were calculated as the number of adverse reactions per patient years. All presented ARs and SARs are treatment emergent and related to trial product, which were defined as the events reported after trial product administration until the follow-up, 12 weeks after first treatment.|Weeks 0-12|Results are based on the safety analysis set (SAS), that included all dosed participants with data after dosing during 8 weeks of treatment.|||Number of ARs per patient years|||Number
2529321|NCT03449342|Primary|Occurrence of Confirmed FVIII Inhibitor Development (≥ 0.6 BU)|The number of participants who confirmed the presence of FVIII inhibitor development (≥ 0.6 BU) during 8 weeks of treatment period.|Weeks 0-8|Results are based on the full analysis set (FAS), that included all dosed participants with data after dosing during 8 weeks of treatment.|||Participants|||Count of Participants
2529322|NCT03448536|Secondary|Pain Relief Scores at Each Evaluation|Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief).|Up to 12 hours post-dose|PP population per treatment received|||Scores on a scale||Standard Deviation|Mean
2529323|NCT03448536|Secondary|Number of Participants by Global Evaluation Scores|Global evaluation was performed either at 12 hours post-dose or immediately prior to the first intake of rescue medication. Global Evaluation Score was based on the question 'Overall, I would rate the effectiveness of the study medication in relieving my menstrual pain as: 0=Poor, 1=Fair, 2=Good, 3=Very Good, 4=Excellent.'|Up to 12 hours post-dose|Subjects who were assessed for this endpoint in PP population per treatment received|||Participants|||Count of Participants
2529324|NCT03448536|Secondary|Pain Intensity Difference (PID) Scores at Each Evaluation|Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement.|Up to 12 hours post-dose|PP population per treatment received|||Scores on a scale||Standard Deviation|Mean
2529325|NCT03448536|Secondary|Time to First Intake of Rescue Medication|Time to first intake of rescue medication was defined as the number of hours elapsed between time of dose and time of rescue medication in each treatment period. Participants would be censored at time of last pain assessment.|Up to 12 hours post-dose|PP population per treatment received|||Hours||95% Confidence Interval|Median
2529326|NCT03448536|Secondary|TOTPAR 6-12 Hours|Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value is 0, and the maximum value is 24. Higher scores was indicative of more pain relief.|From 6 hours to 12 hours post-dose|PP population per treatment received|||Scores on a scale * hours||Standard Error|Least Squares Mean
2529327|NCT03448536|Secondary|TOTPAR Over 0-6 Hours|Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value is 0, and the maximum value is 22. Higher scores was indicative of more pain relief.|Up to 6 hours post-dose|PP population per treatment received|||Scores on a scale * hours||Standard Error|Least Squares Mean
2529328|NCT03448536|Secondary|SPID Over 6-12 Hours|Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -60, and the maximum value could be 60.|From 6 hours to 12 hours post-dose|PP population per treatment received|||Scores on a scale * hours||Standard Error|Least Squares Mean
2529329|NCT03448536|Secondary|SPID Over 0-6 Hours|Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -55, and the maximum value could be 55.|Up to 6 hours post-dose|PP population per treatment received|||Scores on a scale * hours||Standard Error|Least Squares Mean
2529330|NCT03448536|Secondary|Summed Pain Intensity Difference (SPID) Over 0-12 Hours|Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted summed pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value could be -115, and the maximum value could be 115.|Up to 12 hours post-dose|PP population per treatment received|||Scores on a scale * hours||Standard Error|Least Squares Mean
2529352|NCT03447249|Secondary|Absolute Change in Sweat Chloride (SwCl)|Sweat samples were collected using an approved collection device.|From Baseline through Week 24|FAS.|||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
2529353|NCT03447249|Secondary|Number of Pulmonary Exacerbations (PEx)|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.|From Baseline through Week 24|FAS.|||pulmonary exacerbation events|||Number
2530762|NCT03374189|Secondary|Number of Participants With Port-site Hernia|Herniation of bowel segments through port-site|3 days post-op and within one months of surgery||||Participants|||Count of Participants
2529331|NCT03448536|Primary|Sum of Total Pain Relief (TOTPAR) Over 0-12 Hours|Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value is 0, and the maximum value is 46. Higher scores was indicative of more pain relief.|Up to 12 hours post-dose|PP population per treatment received (included all participants who were randomized and provided at least one measure of an efficacy parameter after the first dose of investigational medicinal product [IMP] without any major protocol violations)|||Scores on a scale * hours||Standard Error|Least Squares Mean
2529332|NCT03447821|Secondary|The Number of Patients Recovered From Diarrhoea|Patients were considered to have recovered if fewer than three unformed stools were passed in the previous 24 hours and no symptom of enteric infection were present.|24 hours|ITT|||Participants|||Count of Participants
2529333|NCT03447821|Secondary|Number of Participants With Treatment Failure|A treatment failure is defined as clinical deterioration or worsening of symptoms or illness continuing after 120 h following the first dose.|120 hours|ITT|||Participants|||Count of Participants
2529334|NCT03447821|Secondary|"The Number of Patients Who Are Declared to be Well"|"The patient having must meet all of the following criteria in order to be classified as well: 48 hours with no unformed stools with a maximum of two soft stools and no clinical symptoms of infectious diarrhoea."|48 hours|intent to treat|||Participants|||Count of Participants
2529335|NCT03447821|Secondary|The Number of Unformed Stools Passed Per 24-h Interval|The number of unformed stools passed per 24-h interval, after dosing|192 hours|ITT|||Unformed stools||Standard Deviation|Mean
2529336|NCT03447821|Secondary|The Number of Patients Showing Improvement in Diarrhoea During a 48h Interval|The evaluation of improvement in diarrhoea during a 48 hour interval is defined as a >50% reduction of bowel movements versus the baseline value|48 hours|Intent to treat|||Participants|||Count of Participants
2529337|NCT03447821|Primary|Time to Last Unformed Stool (TLUS)|The safety and preliminary efficacy data of the three doses of the new rifamycin SV formulation tested based upon the time elapsed from the ingestion of the 1st dose of study medication to the passage of the last unformed stool (TLUS)|Up to 7 days|Intent to Treat|||hours||Standard Deviation|Mean
2529338|NCT03447639|Secondary|Diagnosis of UTI at 28 Days|Per NHSN defined CAUTI criteria|28 days after catheter removal|Study terminated due to low enrollment||||||
2529339|NCT03447639|Secondary|Diagnosis of UTI at 7 Days|Per National Healthcare Safety Network (NHSN) defined CAUTI criteria|7 days after catheter removal|Study terminated due to low enrollment||||||
2529340|NCT03447639|Primary|Diagnosis of Urinary Tract Infection (UTI)|Per NHSN defined catheter associated UTI (CAUTI) criteria|48-72 hours after catheter removal|Patients with an indwelling catheter meeting the study eligibility criteria||||||
2529341|NCT03447353|Secondary|Lane Departures|"Total number of lane departures per drive~The total number of lane departures across the drive were analyzed using the SAS GLM procedure."|over course of each simulator drive, approximately 35 minutes per visit|For the purposes of analysis, the individual interventions are broken down to observe differences. Each of the 8 participants experienced the 4 interventions, in varying order, so each intervention will have 8 overall participants analyzed.|||count||Standard Deviation|Mean
2529342|NCT03447353|Primary|SDLP|"Standard Deviation of Lane Position~Standard deviation of lane position was analyzed using the SAS GLM function to identify changes in driver performance. Values represents means across the driving environments studied."|over course of each simulator drive, approximately 35 minutes per visit|For the purposes of analysis, the individual interventions are broken down to observe differences. Each of the 8 participants experienced the 4 interventions, in varying order, so each intervention will have 8 overall participants analyzed.|||centimeters||Standard Deviation|Mean
2529343|NCT03447249|Secondary|Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA||Pre-dose on Week 4, 8, 12, and 16|Pharmacokinetic (PK) set included all randomized participants who carried the intended CFTR allele mutation and received at least 1 dose of study drug in the TC Treatment Period. Here “Number Analyzed” signifies those participants who were evaluable for this outcome measure at specified time points.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2529344|NCT03447249|Secondary|Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)||From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)|Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.|||participants|||Number
2529345|NCT03447249|Secondary|Absolute Change in Body Weight||From Baseline at Week 24|FAS.|||kg||Standard Error|Least Squares Mean
2529346|NCT03447249|Secondary|Absolute Change in BMI Z-score for Participants <=20 Years of Age at Baseline|BMI was defined as weight in kg divided by height in m^2. z-score is a statistical measure to describe whether a mean was above or below the standard. BMI, adjusted for age and sex, was analyzed as BMI-for-age z-score. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of higher BMI.|From Baseline at Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were <=20 years of age at Baseline."|||kg/m^2||Standard Error|Least Squares Mean
2529347|NCT03447249|Secondary|Time-to-first Pulmonary Exacerbation (PEx)|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.|From Baseline through Week 24|FAS.|||days||95% Confidence Interval|Median
2529348|NCT03447249|Secondary|Absolute Change in Cystic Fibrosis Questionnaire Revised (CFQ-R) Respiratory Domain Score|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|From Baseline at Week 4|FAS.|||units on a scale||Standard Error|Least Squares Mean
2529354|NCT03447249|Secondary|Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|From Baseline through Week 24|Full analysis set (FAS) included all randomized participants who carried the intended CFTR allele mutation and received at least 1 dose of study drug in the TC Treatment Period.|||percentage points||Standard Error|Least Squares Mean
2529355|NCT03447249|Primary|Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|From Baseline at Week 4|Analysis population included all participants in the Full Analysis Set (all randomized participants who carried the intended CFTR allele mutation and received at least 1 dose of study drug) who completed the Week 4 Visit or were randomized at least 28 days before the data cutoff date.|||percentage points||Standard Error|Least Squares Mean
2529356|NCT03447015|Secondary|Newborn Health Status|measured by Apgar score. Apgar score is a method to quickly summarize the health of newborn. The Apgar scale is determined by evaluating the newborn baby on five simple criteria (Appearance, Pulse, Grimace, Activity, Respiration) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low|at 5 min of birth of baby||||Participants|||Count of Participants
2529357|NCT03447015|Primary|Woman's Satisfaction With the Birth Experience|Birth satisfaction scale is a Likert-type scale which is scored according to the responses as indicated: I Strongly Agree. 5; I Agree. 4; I Neither Agree or Disagree: 3; • I Disagree.2; • I Strongly Disagree: 1. The scale consists of 30 items, and total number of scores to be obtained from the scale range between 30, and 150 points. As the scores obtained from the scale increase, level of birth satisfaction increases.|24 to 48 hours after birth.||||Participants|||Count of Participants
2529358|NCT03447015|Primary|Mode of Birth|(defined as normal, vacuum extraction, forceps delivery, or cesarean section)|assessed up to child delivery||||Participants|||Count of Participants
2529359|NCT03447015|Primary|Use of Analgesics|used analgesics or did not use|24 to 48 hours after birth.||||Participants|||Count of Participants
2529360|NCT03447015|Primary|Labour Pain Intensity|Visual Analogue pain Scale rating from 0 to 10 in which the woman registers the pain perception, considering 0 no pain and 10 the worst pain imaginable.)|from time of 4 cm cervical dilatation to to time of full crvical dilatation||||Participants|||Count of Participants
2529361|NCT03447015|Primary|Duration of the First Stage of Labour|Labour duration will be measured in minutes.|from 3-4 cm of cervical dilatation until delivery of the child.||||minutes||Standard Deviation|Mean
2529362|NCT03446690|Primary|Enamel Decalcification Index (EDI) Scores|Photographic records will be used to determine the improvements in the white spot lesions. A standard intra-oral photographic camera will be utilized and the photographs will be taken in a light controlled environment and photographs will be captured in a pre-set photographic protocol. The Enamel decalcification index (EDI) will be used to determine the number of white spot lesions present at each time frame.Enamel decalcification index calculation: The facial surface of each tooth was divided into 4 areas (m, Mesial; g, gingival; d, distal; o, occlusal). A score was allocated for each area of each tooth: 0, no decalcification, to 3, decalcifications covering 100% of the area at each time period. Analysis was done at the tooth level, aggregating the enamel decalcification scores from all four areas, creating an EDI for each tooth ranging potentially from 0 to 12. Higher EDI scores indicate more decalcification of teeth and represent a worse outcome.|Photographs were taken for 4 times at monthly intervals. EDI scores were measured and assessed at 1, 2, 3 and 4 months, Month 4 reported. The duration of the observation is an average of 4 months.||||scores on a scale||95% Confidence Interval|Mean
2529363|NCT03445390|Secondary|Count of Participants Requiring Anti-emetic Administration||Up to 24 hours post-operative|Participants who completed both interventions were included in the analysis.|||Participants|||Count of Participants
2529364|NCT03445390|Primary|Post-operative Pain|Patients were asked to rate their pain on a scale of 1 to 10, with 1 being least pain, and 10 being most pain. Pain was assessed continually once per hour during the post-operative period and the average pain score calculated per participant. The average of the participants' average scores is presented for each group.|Up to 24 hours post-operative|Participants who completed both interventions were included in the analysis.|||units on a scale||Standard Deviation|Mean
2529365|NCT03445390|Primary|Post-operative Opioid Consumption|From nursing records how much opioid was administered to each patient post-operatively. Opioid use was measured in micrograms (ug) of fentanyl.|Up to 24 hours post-operative|Participants who completed both interventions were included in the analysis.|||ug||Standard Deviation|Mean
2529366|NCT03445195|Secondary|Microbiologic Eradication|Proportion of patients with a response of microbiologic eradication for the m-MITT(microbiologically modified intent to treat) and ME(microbiologically evaluable) populations at the TOC visit|Baseline to day 21|The analysis population differs for each group because the efficacy endpoint is for specific populations.|||Participants|||Count of Participants
2529367|NCT03445195|Secondary|Clinical Cure|Proportion of patients with a response of clinical cure for the MITT(modified intent to treat), m-MITT (microbiologically modified intent to treat), CE(clinically evaluable), and ME(microbiologically evaluable) populations at the TOC(test of cure) visit.|Baseline to day 21|The number analyzed for each population is different as the efficacy outcome is for the proportion of subjects with a clinical cure for each group.|||Participants|||Count of Participants
2529368|NCT03445195|Primary|Number of Participants With Overall Success|The primary efficacy endpoint for this study was the proportion of patients with an overall success (clinical cure and micro-biologic eradication) for the m-MITT (Micro-biologically Modified Intent-to-Treat) Population at the TOC Visit.|From baseline through day 21||||Participants|||Count of Participants
2529369|NCT03445156|Primary|Other Hits|In the Pilot Study, we counted other hits to targets (i.e. not to a face) within the game. In the Experiment Proper, we counted other hits to the mannequin (i.e., torso instead of the head).|Up to one hour||||shots not at head or face||Standard Deviation|Mean
2529370|NCT03445156|Primary|Hits to Head and Face|In the Pilot Study, we counted hits to the head and face for targets within the game. In the Experiment Proper, we counted hits to the head and face of the mannequin.|Up to one hour||||headshots||Standard Error|Mean
2552317|NCT02796092|Secondary|Complications|Toral number of events related to the procedure in the follow-up (1 year)|12 months||||events|||Number
2529371|NCT03444584|Secondary|Change From Baseline in the Percentage of 24-hrs Glucose Readings That Falls Within Clinically Significant Hypoglycemic Range to the End of Each Dosing as Measured by CGM|Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg. Clinically significant hypoglycemic range is defined as glucose levels of < 54 mg/dL (3.0 mmol/L).|Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg|"An ITT population included all participants who received any dose of study drug (MEDI0382 or placebo) and analyzed according to their randomized treatment group. Here, number analyzed n signifies participants who were analyzed for the specified day."|||Percent of hypoglycemic range||Standard Deviation|Mean
2529372|NCT03444584|Secondary|Change From Baseline in the Percentage of 24-hrs Glucose Readings That Falls Within the Hypoglycemic Range to the End of Each Dosing as Measured by CGM|Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg. Hypoglycemic range is defined as glucose levels of < 70 mg/dL (< 3.9 mmol/L).|Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg|"An ITT population included all participants who received any dose of study drug (MEDI0382 or placebo) and analyzed according to their randomized treatment group. Here, number analyzed n signifies participants who were analyzed for the specified day."|||Percent of hypoglycemic range||Standard Deviation|Mean
2529373|NCT03444584|Secondary|Change From Baseline in the Percentage of 24-hrs Glucose Readings That Falls Within the Hyperglycemic Range to the End of Each Dosing as Measured by CGM|Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg. Hyperglycemic (high glucose) range is defined as glucose levels of > 180 mg/dL (> 10.0 mmol/L).|Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg|"An ITT population included all participants who received any dose of study drug (MEDI0382 or placebo) and analyzed according to their randomized treatment group. Here, number analyzed n signifies participants who were analyzed for the specified day."|||Percent of hyperglycemic range||Standard Deviation|Mean
2529374|NCT03444584|Secondary|Change From Baseline in the Percentage of 24-hrs Glucose Readings That Falls Within the Euglycemic Range to the End of Each Dosing as Measured by CGM|Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg. Euglycemic range is defined as glucose levels of >= 70 mg/dL (>= 3.9 mmol/L) and <= 180 mg/dL (<= 10.0 mmol/L).|Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg|"An ITT population included all participants who received any dose of study drug (MEDI0382 or placebo) and analyzed according to their randomized treatment group. Here, number analyzed n signifies participants who were analyzed for the specified day."|||Percent of Euglycemic Range||Standard Deviation|Mean
2529375|NCT03444584|Secondary|Change From Baseline in Mean Amplitude of Glucose Excursions (MAGE) of 24-hrs Plasma Glucose Readings to the End of Each Dosing Level as Measured by CGM|Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg.|Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg|"An ITT population included all participants who received any dose of study drug (MEDI0382 or placebo) and analyzed according to their randomized treatment group. Here, number analyzed n signifies participants who were analyzed for the specified day."|||mg/dL||Standard Deviation|Mean
2529376|NCT03444584|Secondary|Change From Baseline in Coefficient of Variation of 24-hrs Plasma Glucose Readings to the End of Each Dosing Level as Measured by CGM|Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg.|Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg|"An ITT population included all participants who received any dose of study drug (MEDI0382 or placebo) and analyzed according to their randomized treatment group. Here, number analyzed n signifies participants who were analyzed for the specified day."|||Percent of coefficient of variation||Standard Deviation|Mean
2529377|NCT03444584|Secondary|Change From Baseline in Standard Deviation of 24-hrs Plasma Glucose Readings to the End of Each Dosing Level as Measured by CGM|Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg.|Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg|"An ITT population included all participants who received any dose of study drug (MEDI0382 or placebo) and analyzed according to their randomized treatment group. Here, number analyzed n signifies participants who were analyzed for the specified day."|||mg/dL||Standard Deviation|Mean
2529400|NCT03444090|Secondary|Mean Colon Adenoma Per Colonoscopy|Mean colon adenoma per procedure is defined as the total number of adenomas detected divided by the number of colonoscopies.|During procedure, approximately one hour||||adenomas/colonoscopy||Standard Deviation|Mean
2552318|NCT02796092|Secondary|Complications|Total number of events during the procedure|intraoperative||||minor events|||Number
2529378|NCT03444584|Secondary|Change From Baseline in Mean 24-hrs Plasma Glucose to the End of Each Dosing Level as Measured by CGM|Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg.|Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg|"An ITT population included all participants who received any dose of study drug (MEDI0382 or placebo) and analyzed according to their randomized treatment group. Here, number analyzed n signifies participants who were analyzed for the specified day."|||mg/dL||Standard Deviation|Mean
2529379|NCT03444584|Secondary|Change From Baseline in Plasma Glucose AUC24-hrs to the End of Each Dosing Level as Measured by Continuous Glucose Monitoring (CGM)|Continuous glucose monitoring is a minimally invasive device applied to the skin in the upper arm that provides a measure of interstitial glucose levels every 15 minutes. Continuous glucose monitoring measures glucose excursions during different meals and at different times of the day. End of dosing: Day 7 for MEDI0382 100 μg; Day 14 for MEDI0382 200 μg; and Day 28 for MEDI0382 300 μg.|Day -1 (Baseline) through Day 7 for MEDI0382 100 μg, Day 14 for MEDI0382 200 μg, and Day 28 for MEDI0382 300 μg|"An ITT population included all participants who received any dose of study drug (MEDI0382 or placebo) and analyzed according to their randomized treatment group. Here, number analyzed n signifies participants who were analyzed for the specified day."|||hr.mg/dL||Standard Deviation|Mean
2529380|NCT03444584|Secondary|Number of Participants With Positive Anti-drug Antibodies (ADA) Titer to MEDI0382|Number of participants with positive Anti-drug antibodies (ADA) titer to MEDI0382 are reported.|Day 1 (pre-dose), on Day 29 , and 28 days post last dose (end of study visit; approximately 8 weeks)|"Immunogenicity population included all participants who received any dose of study drug (MEDI0382 or placebo) and analyzed according to the treatment they actually received and had at least one serum sample for immunogenicity testing. Here, number analyzed n signifies participants who were analyzed for the specified day."|||Participants|||Count of Participants
2529381|NCT03444584|Secondary|Apparent Clearance (CL/F) of Dapagliflozin|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. The CL/F of Dapagliflozin is reported.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days -1, 7, 14, and 28|"Dapagliflozin PK population included all participants who received at least 1 dose of dapagliflozin and had at least 1 dapagliflozin PK sample above the lower limit of quantitation. Here, number analyzed n signifies participants who were analyzed for the specified day."|||L/Hr||Full Range|Geometric Mean
2529382|NCT03444584|Secondary|Apparent Clearance (CL/F) of MEDI0382|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. The CL/F of MEDI0382 is reported.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days 7, 14, and 28|"MEDI0382 PK population included all participants who received at least 1 dose of MEDI0382 and had at least 1 MEDI0382 PK sample above the lower limit of quantitation. Here, number analyzed n signifies participants who were analyzed for the specified day."|||L/hr||Full Range|Geometric Mean
2529383|NCT03444584|Secondary|Terminal Elimination Half-life (t½) of Dapagliflozin|Terminal half-life is the time required for the plasma concentration to fall by 50% during the terminal phase. The t½ of Dapagliflozin is reported.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days -1, 7, 14, and 28|"Dapagliflozin PK population included all participants who received at least 1 dose of dapagliflozin and had at least 1 dapagliflozin PK sample above the lower limit of quantitation. Here, number analyzed n signifies participants who were analyzed for the specified day."|||Hours||Full Range|Geometric Mean
2529384|NCT03444584|Secondary|Terminal Elimination Half-life (t½) of MEDI0382|Terminal half-life is the time required for the plasma concentration to fall by 50% during the terminal phase. The t½ of MEDI0382 is reported.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days 7, 14, and 28|"MEDI0382 PK population included all participants who received at least 1 dose of MEDI0382 and had at least 1 MEDI0382 PK sample above the lower limit of quantitation. Here, number analyzed n signifies participants who were analyzed for the specified day."|||Hours||Full Range|Geometric Mean
2529385|NCT03444584|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) of Dapagliflozin|Time to reach maximum observed serum concentration (Tmax) of Dapagliflozin is reported.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days -1, 7, 14, and 28|"Dapagliflozin PK population included all participants who received at least 1 dose of dapagliflozin and had at least 1 dapagliflozin PK sample above the lower limit of quantitation. Here, number analyzed n signifies participants who were analyzed for the specified day."|||Hours||Full Range|Median
2529386|NCT03444584|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI0382|Time to reach maximum observed serum concentration (Tmax) of MEDI0382 is reported.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days 7, 14, and 28|"MEDI0382 PK population included all participants who received at least 1 dose of MEDI0382 and had at least 1 MEDI0382 PK sample above the lower limit of quantitation. Here, number analyzed n signifies participants who were analyzed for the specified day."|||Hours||Full Range|Median
2529387|NCT03444584|Secondary|Maximum Observed Serum Concentration (Cmax) of Dapagliflozin|Maximum observed serum concentration (Cmax) of Dapagliflozin is reported.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days -1, 7, 14, and 28|"Dapagliflozin PK population included all participants who received at least 1 dose of dapagliflozin and had at least 1 dapagliflozin PK sample above the lower limit of quantitation. Here, number analyzed n signifies participants who were analyzed for the specified day."|||ng/mL||Full Range|Geometric Mean
2529388|NCT03444584|Secondary|Maximum Observed Serum Concentration (Cmax) of MEDI0382|Maximum observed serum concentration (Cmax) of MEDI0382 is reported.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days 7, 14, and 28|"MEDI0382 PK population included all participants who received at least 1 dose of MEDI0382 and had at least 1 MEDI0382 PK sample above the lower limit of quantitation. Here, number analyzed n signifies participants who were analyzed for the specified day."|||ng/mL||Full Range|Geometric Mean
2529401|NCT03444090|Primary|Percentage of Participants With Detection of at Least One Adenoma Per Procedure|Colon adenoma detection rate is defined as the proportion of colonoscopies where at least one adenoma is found.|During procedure, approximately one hour||||percentage of participants||95% Confidence Interval|Mean
2529389|NCT03444584|Secondary|Area Under the Plasma Concentration-time Curve During the Dosing Period (AUCtau) of Dapagliflozin|Area under the plasma Concentration-time curve during the dosing period (AUCtau) of Dapagliflozin is reported.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days -1, 7, 14, and 28|"Dapagliflozin PK population included all participants who received at least 1 dose of dapagliflozin and had at least 1 dapagliflozin PK sample above the lower limit of quantitation. Here, number analyzed n signifies participants who were analyzed for the specified day."|||ng.hr/mL||Full Range|Geometric Mean
2529390|NCT03444584|Secondary|Area Under the Plasma Concentration-time Curve During the Dosing Period (AUCtau) of MEDI0382|Area under the plasma concentration-time curve during the dosing period (AUCtau) of MEDI0382 is reported.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days 7, 14, and 28|"MEDI0382 PK population included all participants who received at least 1 dose of MEDI0382 and had at least 1 MEDI0382 PK sample above the lower limit of quantitation. Here, number analyzed n signifies participants who were analyzed for the specified day."|||ng.hr/mL||Full Range|Geometric Mean
2529391|NCT03444584|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC [0-∞]) of Dapagliflozin|Area under the plasma concentration time curve from time zero to infinity (AUC [0-∞]) of Dapagliflozin is reported.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days -1, 7, 14, and 28|"Dapagliflozin PK population included all participants who received at least 1 dose of dapagliflozin and had at least 1 dapagliflozin PK sample above the lower limit of quantitation. Here, number analyzed n signifies participants who were analyzed for the specified day."|||ng.hr/mL||Full Range|Geometric Mean
2529392|NCT03444584|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC [0-∞]) of MEDI0382|Area under the plasma concentration time curve from time zero to infinity (AUC [0-∞]) of MEDI0382 is reported.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, and 24 hrs post-dose on Days 7, 14, and 28|"MEDI0382 pharmacokinetic (PK) population included all participants who received at least 1 dose of MEDI0382 and had at least 1 MEDI0382 PK sample above the lower limit of quantitation. Here, number analyzed n signifies participants who were analyzed for the specified day."|||ng.hr/mL||Full Range|Geometric Mean
2529393|NCT03444584|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs|Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported.|Day 1 through 28 days after the last dose of MEDI0382 (approximately 8 weeks)|As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529394|NCT03444584|Secondary|Number of Participants With Abnormal Physical Examinations Reported as TEAEs|Number of participants with abnormal physical examinations reported as TEAEs are reported.|Day 1 through 28 days after the last dose of MEDI0382 (approximately 8 weeks)|As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529395|NCT03444584|Secondary|Number of Participants With Abnormal Vital Signs Reported as TEAEs|Number of participants with abnormal vital signs reported as TEAEs are reported.|Day 1 through 28 days after the last dose of MEDI0382 (approximately 8 weeks)|As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529396|NCT03444584|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Reported as TEAEs|Number of participants with abnormal 12-lead ECG reported as TEAEs are reported.|Day 1 through 28 days after the last dose of MEDI0382 (approximately 8 weeks)|As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529397|NCT03444584|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.|Day 1 through 28 days after the last dose of MEDI0382 (approximately 8 weeks)|As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2529398|NCT03444584|Primary|Percent Change From Baseline to Day 28 in Plasma Glucose AUC0-4hrs as Measured by MMTT|The MMTT test involved the consumption of a standardised liquid meal (nutritional supplement of fat, carbohydrate, and protein)within 5 minutes. On Day -1 and on Day 28, following a minimum 10-hour fast, serial of blood samples were obtained prior and through 240 minutes after consumption of standardized meal for the measurement of glucose metabolism (with no additional food intake during this time).|Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised meal on Day -1 (Baseline) and Day 28|"An ITT population included all participants who received any dose of study drugs and analyzed according to their randomized treatment group. Here, number of participants analyzed N signifies participants who were analyzed for the specified outcome measure."|||Percent change in Glucose AUC0-4hrs||95% Confidence Interval|Least Squares Mean
2529399|NCT03444584|Primary|Change From Baseline to Day 28 in Plasma Glucose Area Under the Concentration Time-curve From Time 0 to 4 Hours (AUC0-4hrs) as Measured by Mixed-meal Tolerance Test (MMTT)|The MMTT test involved the consumption of a standardised liquid meal (nutritional supplement of fat, carbohydrate, and protein) within 5 minutes. On Day -1 and on Day 28, following a minimum 10 hour fast, serial of blood samples were obtained prior and through 240 minutes after consumption of standardized meal for the measurement of glucose metabolism (with no additional food intake during this time).|Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised meal on Day -1 (Baseline) and Day 28|"Intent-to-treat (ITT) population included all participants who received any dose of study drugs analyzed according to their randomized treatment group. Here, number of participants analyzed N signifies participants who were analyzed for the specified outcome measure."|||hr·mg/dL||95% Confidence Interval|Least Squares Mean
2552753|NCT02790463|Primary|sUA < 6.0 mg/dl at 1 Year|Achievement of serum uric acid (sUA) < 6.0 mg/dl at 1 year|12 months||||Participants|||Count of Participants
2529402|NCT03443713|Secondary|Mean Sensed Glucose|Assess the mean Dexcom G6 reported sensor glucose values using values uploaded to Dexcom Clarity.The mean sensed glucose was averaged across days 22-28.|Days 22-28|25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.|||mg/dl||Standard Deviation|Mean
2529403|NCT03443713|Secondary|Percent of Time With Sensed Glucose Less Than 54 mg/dl|Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 54 mg/dl was averaged across days 22-28.|Days 22-28|25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.|||percentage of time||Standard Deviation|Mean
2529404|NCT03443713|Secondary|Mean Sensed Glucose|Assess the mean Dexcom G6 reported sensor glucose values using values uploaded to Dexcom Clarity.The mean sensed glucose was averaged across days 1-7.|Days 1-7|25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.|||mg/dl||Standard Deviation|Mean
2529405|NCT03443713|Secondary|Percent of Time With Sensed Glucose Less Than 54 mg/dl|Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 54 mg/dl was averaged across days 1-7.|Days 1-7|25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.|||percentage of time||Standard Deviation|Mean
2529406|NCT03443713|Primary|Percent of Time With Sensed Glucose Less Than 70 mg/dl|Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 70 mg/dl was averaged across days 22-28.|Days 22-28|25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.|||percentage of time||Standard Deviation|Mean
2529407|NCT03443713|Primary|Percent of Time With Sensed Glucose 70-180 mg/dl|Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose 70-180 mg/dl was averaged across days 22-28.|Days 22-28|25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.|||percentage of time||Standard Deviation|Mean
2529408|NCT03443713|Primary|Percent of Time With Sensed Glucose Less Than 70 mg/dl|Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less than 70 mg/dl was averaged across days 1-7.|Days 1-7|25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.|||percentage of time||Standard Deviation|Mean
2529409|NCT03443713|Primary|Percent of Time With Sensed Glucose 70-180 mg/dl|Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using values uploaded to Dexcom Clarity. The percent of time with sensed glucose 70-180 mg/dl was averaged across days 1-7.|Days 1-7|25 subjects were enrolled. One subject assigned to High intensity interval exercise dropped out before completing the exercise visits.|||percentage of time||Standard Deviation|Mean
2529410|NCT03443414|Secondary|Number of Patients With Treatment Emergent Adverse Events (TEAEs)|"The number of patients with TEAEs for each the following categories are presented: any TEAE, any drug-related TEAE, any severe TEAE, any serious TEAE, serious drug-related TEAE, any TEAE leading to drug interruption, any TEAE leading to drug discontinuation, and any TEAE leading to death.~All AEs which started after the first dose of investigational product.or started prior to first dose and worsened, based on the Investigator assessment of severity, on or after first dose were considered to be treatment-emergent."|Up to end of study (approximately 6 weeks)|The safety analysis set consisted of all patients who received at least 1 dose of investigational product during the study.|||Patients|||Number
2529411|NCT03443414|Secondary|Mean Change From Baseline in Breathlessness as Assessed Using the St George's Respiratory Questionnaire (SGRQ) at Week 4|Patients completed the COPD specific SGRQ (SGRQ-C) consisting of 14 items each weighted from 0 to a possible maximum of 100. Items 1-7 produced the symptoms score, 9-12 the activity score, and items 8, 10, 11, 13 and 14 the impacts score. Each component sub-score was calculated as a percentage of the summed weights of each item out of the sum of the maximum possible weight for that component (range 0-100). The total score was calculated by summing the weights to all positive responses in each component, where a positive item indicated the presence of symptoms, expressed as a percentage (range 0-100). Higher scores indicate a worse outcome. Baseline assessment was pre-dose at Visit 2. MMRM was used to model the change from baseline using baseline as a continuous fixed effect, randomized treatment, week and treatment-by-week as categorical fixed effect, patient as random effect. The LS mean change from baseline in the total, symptoms, activity and impact SGRQ-C scores are presented.|Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).|The FAS consisted of all randomized patients, who received at least 1 dose of investigational product during the study and with at least 1 post-treatment efficacy data assessment. Data is presented for the numbers of patients with at least 1 on-treatment value who contributed to the model estimate.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2529422|NCT03443063|Secondary|Metabolite-to-Parent Ratio of AUC(0-inf), Corrected for Molecular Weights (MPR AUC[0-inf]) of Metabolites of Lemborexant (M4, M9, and M10)|The AUC metabolite to parent ratio (MPR) is the ratio of AUC(0-inf) of the individual metabolite to AUC(0-inf) of lemborexant, corrected for molecular weights.|Day 1: predose, 0.5 up to 240 hours postdose|The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter. Here “number analyzed” signifies the participants who were evaluable for analysis for specific metabolite of lemborexant for this outcome measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2529423|NCT03443063|Secondary|Apparent Volume of Distribution (Vz/F) Based on the Terminal Phase of Lemborexant|The apparent volume of distribution gives information about the amount of Lemborexant distributed in body tissue rather than the blood/plasma. Vz/F for parent Lemborexant only was calculated as Dose /([ λz]*[AUC0-inf]).|Day 1: predose, 0.5 up to 240 hours postdose|The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter. Here “overall number of participants analyzed” signifies the participants who were evaluable for analysis for this outcome measure.|||liter (L)||Geometric Coefficient of Variation|Geometric Mean
2529412|NCT03443414|Secondary|Mean Change From Baseline in COPD Symptoms Using the Exacerbations of Chronic Pulmonary Disease Tool Patient-Reported Outcome (EXACT-PRO) Scoring at Week 4|Patients completed an electronic diary (e-diary) once daily which used the 14-item EXACT-PRO instrument to assess COPD symptoms. The EXACT-PRO instrument contains 11 respiratory symptom questions that comprise the derivative Evaluating Respiratory Symptoms (E-RS) instrument that was used to measure the effect of treatment with RPL554 on the severity of COPD symptoms overall. The E-RS tool contains 3 subscales to assess breathlessness, cough/sputum and chest symptoms. In addition to the subscale scores, a total score for the E-RS part was obtained. The raw totals for the E-RS score and for each of the subscales were converted to a scale range of 0 to 100 (least symptomatic to most symptomatic). MMRM was used to model the change from baseline using baseline as a continuous fixed effect, randomized treatment, week and treatment-by-week as categorical fixed effect, and patient as random effect. Baseline was the last non-missing assessment taken prior to investigational product start date.|Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).|The FAS consisted of all randomized patients, who received at least 1 dose of investigational product during the study and with at least 1 post-treatment efficacy data assessment. Data is presented for the number of patients with at least 1 on-treatment value who contributed to the model estimate.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2529413|NCT03443414|Secondary|Mean Change From Baseline FEV1 to Average FEV1 (Over 12 Hours) at Day 1 and Week 4|"Average FEV1 over 12 hours was defined as the area under the curve from 0 to 12 hours post-dose (AUC[0-12]) of the FEV1 values collected during the visit under analysis (Day 1 or Week 4), divided by the length of the time interval of interest (in hours). The AUC was calculated using the trapezoidal rule. Baseline was defined as the FEV1 pre-dose assessment (-15 minutes) collected at Visit 2. MMRM was used to model the change from baseline FEV1 using baseline FEV1 as a continuous fixed effect, randomized treatment, week and treatment-by-week as categorical fixed effect, and patient as random effect.~The LS mean change from baseline FEV1 to average FEV1 over 12 hours at Day 1 and at Week 4 is presented."|Baseline (pre-dose, Visit 2), up to 12 hours post-dose at Visit 2 (Day 1) and Visit 6 (Week 4).|The FAS consisted of all randomized patients, who received at least 1 dose of investigational product during the study and with at least 1 post-treatment efficacy data assessment. Data is presented for the number of patients with at least 1 on-treatment value who contributed to the model estimate.|||Liters||95% Confidence Interval|Least Squares Mean
2529414|NCT03443414|Secondary|Mean Change From Baseline FEV1 to Morning Trough FEV1 at Week 4|"Morning trough FEV1 was defined as the last pre-dose value at Visit 6. Baseline was defined as the FEV1 pre-dose assessment (-15 minutes) collected at Visit 2. MMRM was used to model the change from baseline FEV1 using baseline FEV1 as a continuous fixed effect, randomized treatment, week and treatment-by-week as categorical fixed effect, and patient as random effect.~The LS mean change from baseline FEV1 to morning trough FEV1 at Week 4 is presented."|Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).|The FAS consisted of all randomized patients, who received at least 1 dose of investigational product during the study and with at least 1 post-treatment efficacy data assessment. Data is presented for the number of patients with at least 1 on-treatment value who contributed to the model estimate.|||Liters||95% Confidence Interval|Least Squares Mean
2529415|NCT03443414|Primary|Mean Change From Baseline in Peak FEV1 (Over 3 Hours) at Week 4|"Spirometry assessments were used to assess pulmonary function including the forced expiratory volume in 1 second (FEV1). Peak FEV1 at Week 4 was defined as the maximum post-dose value among the 30 minutes, 1, 2 and 3 hour assessments collected at Visit 6. Baseline was defined as the FEV1 pre-dose assessment (-15 minutes) collected at Visit 2. A mixed model for repeated measures (MMRM) was used to model the change from baseline FEV1 using baseline FEV1 as a continuous fixed effect, randomized treatment, week and treatment-by-week as categorical fixed effect, and patient as random effect.~The least squares (LS) mean change from baseline FEV1 to peak FEV1 (as measured over 3 hours) at Week 4 is presented."|Baseline (pre-dose, Visit 2) and Week 4 (Visit 6).|The full analysis set (FAS) consisted of all randomized patients, who received at least 1 dose of investigational product during the study and with at least 1 post-treatment efficacy data assessment. Data is presented for the number of patients with at least 1 on-treatment value who contributed to the model estimate.|||Liters||95% Confidence Interval|Least Squares Mean
2529416|NCT03443063|Secondary|Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Parameter Values||Up to Day 11|The safety analysis set was the group of participants who were dosed with the test drug and had at least one postdose safety assessment.|||Participants|||Count of Participants
2529417|NCT03443063|Secondary|Number of Participants With Clinically Significant Abnormal Vital Sign Values||Up to Day 11|The safety analysis set was the group of participants who were dosed with the test drug and had at least one postdose safety assessment.|||Participants|||Count of Participants
2529418|NCT03443063|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities||Up to Day 11|The safety analysis set was the group of participants who were dosed with the test drug and had at least one postdose safety assessment.|||Participants|||Count of Participants
2529419|NCT03443063|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||Up to Day 11|The safety analysis set was the group of participants who were dosed with the test drug and had at least one postdose safety assessment.|||Participants|||Count of Participants
2529420|NCT03443063|Secondary|Apparent Clearance Relative to the Unbound Plasma Concentration (CLu/F) Based on AUCu of Lemborexant|Unbound fraction of drug in plasma was calculated as 100% - mean percent of Lemborexant bound to plasma protein for each participant.|Day 1: predose, 0.5 up to 240 hours postdose|The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter. Here “overall number of participants analyzed” signifies the participants who were evaluable for analysis for this outcome measure.|||liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2529421|NCT03443063|Secondary|Plasma Protein Unbound Fraction (Fu) of Lemborexant and Its Metabolites (M4, M9, and M10)|Unbound fraction of drug in plasma was calculated as 100% minus (-) mean percent of Lemborexant and Its Metabolites M4. M9. M10 bound to plasma protein for each participant.|Day 1: predose, 0.5 up to 240 hours postdose|The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter. Here “number analyzed” signifies the participants who were evaluable for analysis for lemborexant and for specific metabolite of lemborexant for this outcome measure.|||% unbound||Geometric Coefficient of Variation|Geometric Mean
2529424|NCT03443063|Secondary|Apparent Body Clearance (CL/F) of Lemborexant|CL/F is the clearance for parent Lemborexant only and was calculated as Dose/[AUC0-inf]. Blood samples were analyzed for the amount of Lemborexant in the plasma.|Day 1: predose, 0.5 up to 240 hours postdose|The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter. Here “overall number of participants analyzed” signifies the participants who were evaluable for analysis for this outcome measure.|||liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2529425|NCT03443063|Secondary|Observed Elimination Rate Constant (LambdaZ) of Lemborexant and Its Metabolites (M4, M9, and M10)|Estimated by linear regression through at least three data points (not including tmax) in the terminal phase of the log concentration-time profile.|Day 1: predose, 0.5 up to 240 hours postdose|The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter. Here “number analyzed” signifies the participants who were evaluable for analysis for lemborexant and for specific metabolite of lemborexant for this outcome measure.|||per hour (1/h)||Geometric Coefficient of Variation|Geometric Mean
2529426|NCT03443063|Secondary|Observed Terminal Elimination Half-life (t1/2) of Lemborexant and Its Metabolites (M4, M9, and M10)|Terminal plasma half-life is the time required for plasma/blood concentration to decrease by 50%. This is not the time required to eliminate half the administered dose.|Day 1: predose, 0.5 up to 240 hours postdose|The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter. Here “number analyzed” signifies the participants who were evaluable for analysis for lemborexant and for specific metabolite of lemborexant for this outcome measure.|||hour (h)||Full Range|Median
2529427|NCT03443063|Secondary|Percentage of AUC(0-inf) Based on Extrapolation (AUCex) of Lemborexant and Its Metabolites (M4, M9, and M10)|AUCex was calculated by dividing the difference of (AUC(0-inf) and AUC(0-t)) by value of AUC(0-inf) and then multiplying the value by 100.|Day 1: predose, 0.5 up to 240 hours postdose|The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter. Here “number analyzed” signifies the participants who were evaluable for analysis for lemborexant and for specific metabolite of lemborexant for this outcome measure.|||percentage of AUCex||Geometric Coefficient of Variation|Geometric Mean
2529428|NCT03443063|Secondary|Area Under the Plasma Concentration-Time Curve Adjusted by Unbound Fraction of Plasma (AUCu) of Lemborexant and Its Metabolites (M4, M9, and M10)|AUCu was defined as the AUC(0-inf) adjusted by unbound fraction in plasma, and calculated by multiplying the value of AUC(0-inf) with Plasma protein unbound fraction (fu).|Day 1: predose, 0.5 up to 240 hours postdose|The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter. Here “number analyzed” signifies the participants who were evaluable for analysis for lemborexant and for specific metabolite of lemborexant for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2529429|NCT03443063|Secondary|Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC[0-inf]) of Metabolites of Lemborexant (M4, M9, and M10)||Day 1: predose, 0.5 up to 240 hours postdose|The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter. Here “number analyzed” signifies the participants who were evaluable for analysis for specific metabolite of lemborexant for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2529430|NCT03443063|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Metabolites of Lemborexant (M4, M9, and M10)||Day 1: predose, 0.5 up to 240 hours postdose|The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2529431|NCT03443063|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours Post Dose (AUC[0-72h]) of Metabolites of Lemborexant (M4, M9, and M10)||Day 1: predose, 0.5 up to 72 hours postdose|The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2529432|NCT03443063|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours Post Dose (AUC[0-8h]) of Lemborexant and Its Metabolites (M4, M9, and M10)||Day 1: predose, 0.5 up to 8 hours postdose|The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2529433|NCT03443063|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Lemborexant and Its Metabolites (M4, M9, and M10)||Day 1: predose, 0.5 up to 240 hours postdose|The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter.|||hour (h)||Full Range|Median
2529434|NCT03443063|Secondary|Maximum Observed Plasma Concentration (Cmax) of Metabolites of Lemborexant (M4, M9, and M10)||Day 1: predose, 0.5 up to 240 hours postdose|The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2529435|NCT03443063|Primary|Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC[0-inf]) of Lemborexant||Day 1: predose, 0.5 up to 240 hours postdose|The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter. Here “overall number of participants analyzed” signifies the participants who were evaluable for analysis for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2529436|NCT03443063|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Lemborexant||Day 1: predose, 0.5 up to 240 hours postdose|The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2529437|NCT03443063|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours Post Dose (AUC[0-72h]) of Lemborexant||Day 1: predose, 0.5 up to 72 hours postdose|The PK analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2529438|NCT03443063|Primary|Maximum Observed Plasma Concentration (Cmax) of Lemborexant||Day 1: predose, 0.5 up to 240 hours postdose|The pharmacokinetic (PK) analysis set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least one PK parameter.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2529439|NCT03442933|Secondary|Roland-Morris Questionnaire (RMQ)|The functional disability caused by LBP through the Roland-Morris Questionnaire (RMQ). The score ranges from 0 to 24, with 0 indicating no disability and 24 maximum disability.|Baseline||||Participants|||Count of Participants
2529440|NCT03442933|Primary|Pressure Pain Threshold (PPT)|Measured from 0 to 10kg/cm2 with a manual mechanical algometer (FDK/FDN, Wagner Instruments, 1217 Greenwich, CT 06836), which has bilaterally shown an excellent reliability, reproducibility, and sensitivity on the lumbar erector spinae muscles.|Baseline and after 3 hours||||kg/cm^2||Standard Deviation|Mean
2529441|NCT03442933|Primary|Maximal Radial Displacement (Dm)|The variable Dm is given by the radial displacement of the muscular belly in a transverse plane, expressed in milimeters (mm) and depends on muscle tone or stiffness. A low Dm is related to a high muscle tone or an excess of stiffness, while a high Dm value indicates a lack of muscle tone or stiffness defect.|Baseline and after 3 hours||||mm||Standard Deviation|Mean
2529442|NCT03442933|Primary|Low Back Pain Perception (LBPP)|This variable records the intensity pain perceived on the lumbar region (LBPP) by using a 0 to 10 numeric pain-rating scale (NPRS). This is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). The LBPP was measured before and after completing each time trial.|Change between Baseline and 3 hours|Amateur males from mixed cycling modalities with an experience in the practice of cycling greater than 3 years|||units on a scale||Standard Deviation|Mean
2529443|NCT03442725|Secondary|Amount of Unchanged Telotristat Ethyl and LP-778902 Excreted in Urine.|For assessment of urine PK parameters, the amount of unchanged telotristat ethyl and its active metabolite LP-778902 (also known as telotristat) excreted in urine was determined.|Day 1 (predose and 0 to 4 hours, 4 to 8 hours, 8 to 12 hours, 12 to 24 hours post-dose), Day 2 (24 to 48 hours post-dose), Day 3 (48 to 72 hours post-dose)|The PK population included all subjects who received the single oral dose of study drug and had no major protocol deviations affecting the PK variables and for whom the renal function group was assessable and who had a sufficient number of plasma concentrations to estimate the main PK parameters.|||ng||Standard Deviation|Mean
2529444|NCT03442725|Primary|Metabolic Ratios (MR) of Cmax (LP-778902/Telotristat Ethyl)|"The following MRs of Cmax were calculated:~MRCmax = (Cmax LP-778902)/(Cmax telotristat ethyl)~MRCmaxTotal = (Cmax LP-778902)/(Cmax LP-778902+Cmax telotristat ethyl)~The ratios were also normalised by molecular weight (MW) of the metabolites (telotristat ethyl: MW=575 grams/mole (g/mol) and LP-778902: MW=547 g/mol). Both the normalised and not normalised ratios are presented."|Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours), Day 2 (24 hours), Day 3 (48 hours) and Day 4 (72 hours)|The PK population included all subjects who received the single oral dose of study drug and had no major protocol deviations affecting the PK variables and for whom the renal function group was assessable and who had a sufficient number of plasma concentrations to estimate the main PK parameters.|||Ratio||Standard Deviation|Mean
2529445|NCT03442725|Primary|AUC0-tlast for the Unbound Fraction (AUC0-tlastu) of Unbound Telotristat Ethyl, LP-778902 and LP-951757|AUC0-tlastu of unbound telotristat ethyl and its active metabolite LP-778902 (also known as telotristat) and the inactive metabolite LP-951757 was calculated using the unbound fraction fu (defined for each subject as the mean over all time points of the mean of fu) and determined using non-compartmental analysis.|Day 1 (0.5, 1, 2 and 3 hours post-dose)|The PK population included all subjects who received the single oral dose of study drug and had no major protocol deviations affecting the PK variables and for whom the renal function group was assessable and who had a sufficient number of plasma concentrations to estimate the main PK parameters.|||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2529446|NCT03442725|Primary|AUC0-inf for the Unbound Fraction (AUC0-infu) of Unbound Telotristat Ethyl, LP-778902 and LP-951757|AUC0-infu of unbound telotristat ethyl and its active metabolite LP-778902 (also known as telotristat) and the inactive metabolite LP-951757 was calculated using the unbound fraction fu (defined for each subject as the mean over all time points of the mean of fu) and determined using non-compartmental analysis.|Day 1 (0.5, 1, 2 and 3 hours post-dose)|The PK population included all subjects who received the single oral dose of study drug and had no major protocol deviations affecting the PK variables and for whom the renal function group was assessable and who had a sufficient number of plasma concentrations to estimate the main PK parameters.|||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2529447|NCT03442725|Primary|Cmax for the Unbound Fraction (Cmaxu) of Unbound Telotristat Ethyl, LP-778902 and LP-951757|Cmaxu of unbound telotristat ethyl and its active metabolite LP-778902 (also known as telotristat) and the inactive metabolite LP-951757 was calculated using the unbound fraction fu (defined for each subject as the mean over all time points of the mean of fu) and determined using non-compartmental analysis.|Day 1 (0.5, 1, 2 and 3 hours post-dose)|The PK population included all subjects who received the single oral dose of study drug and had no major protocol deviations affecting the PK variables and for whom the renal function group was assessable and who had a sufficient number of plasma concentrations to estimate the main PK parameters.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2529448|NCT03442725|Primary|Percentage of Unbound Plasma Fraction (fu) of Total Telotristat Ethyl, LP-778902 and LP-951757|Plasma protein binding was assessed using equilibrium dialysis followed by LC-MS/MS for determination of unbound drug concentrations. The plasma protein binding of telotristat ethyl, LP-778902 and LP-951757 was assessed and the percentage of fu was calculated as the mean over time of the mean of the available replicates.|Day 1 (0.5, 1, 2 and 3 hours post-dose)|The PK population included all subjects who received the single oral dose of study drug and had no major protocol deviations affecting the PK variables and for whom the renal function group was assessable and who had a sufficient number of plasma concentrations to estimate the main PK parameters.|||Percentage of fu||Standard Deviation|Mean
2529457|NCT03442699|Secondary|Structured Interview Guide for the Hamilton Rating Scale for Depression (SIGH-D)|The SIGH-D is a clinician rated measure of depression symptom severity. Scores range from 0 to 52 with higher total scores indicating more severe depression.|Pre-treatment through post-treatment up to 24 days, 16 days on average||||score on a scale||Standard Deviation|Mean
2530763|NCT03374189|Secondary|Number of Participants With Need for Additional Instrument|Need for additional instrument during procedure|At the time of surgery||||Participants|||Count of Participants
2529449|NCT03442725|Primary|Apparent Volume of Distribution (Vd/F) of Total Telotristat Ethyl|"Blood samples were collected to determine plasma levels of telotristat ethyl using a validated, specific and sensitive LC-MS/MS bioanalytical method with a LOQ of 0.5 ng/mL.~Vd/F was determined using non-compartmental analysis."|Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours), Day 2 (24 hours), Day 3 (48 hours) and Day 4 (72 hours)|The PK population included all subjects who received the single oral dose of study drug and had no major protocol deviations affecting the PK variables and for whom the renal function group was assessable and who had a sufficient number of plasma concentrations to estimate the main PK parameters.|||Litres||Standard Deviation|Mean
2529450|NCT03442725|Primary|Apparent Total Clearance From Plasma (CL/F) of Total Telotristat Ethyl|"Blood samples were collected to determine plasma levels of telotristat ethyl using a validated, specific and sensitive LC-MS/MS bioanalytical method with a LOQ of 0.5 ng/mL.~CL/F was determined using non-compartmental analysis."|Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours), Day 2 (24 hours), Day 3 (48 hours) and Day 4 (72 hours)|The PK population included all subjects who received the single oral dose of study drug and had no major protocol deviations affecting the PK variables and for whom the renal function group was assessable and who had a sufficient number of plasma concentrations to estimate the main PK parameters.|||Litres/hour||Standard Deviation|Mean
2529451|NCT03442725|Primary|Apparent First Order Terminal Elimination Rate Constant (λz) of Total Telotristat Ethyl, LP-778902 and LP-951757|"Blood samples were collected to determine plasma levels of telotristat ethyl, its active metabolite LP-778902 (also known as telotristat) and the inactive metabolite LP-951757 using a validated, specific and sensitive LC-MS/MS bioanalytical method with a LOQ of 0.5 ng/mL for telotristat ethyl and 2 ng/mL for LP-778902 and LP-951757.~λz was determined using non-compartmental analysis."|Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours), Day 2 (24 hours), Day 3 (48 hours) and Day 4 (72 hours)|The PK population included all subjects who received the single oral dose of study drug and had no major protocol deviations affecting the PK variables and for whom the renal function group was assessable and who had a sufficient number of plasma concentrations to estimate the main PK parameters.|||hour^-1||Standard Deviation|Mean
2529452|NCT03442725|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Time Corresponding to the Last Quantifiable Concentration (AUC0-tlast) of Total Telotristat Ethyl, LP-778902 and LP-951757|"Blood samples were collected to determine plasma levels of telotristat ethyl, its active metabolite LP-778902 (also known as telotristat) and the inactive metabolite LP-951757 using a validated, specific and sensitive LC-MS/MS bioanalytical method with a LOQ of 0.5 ng/mL for telotristat ethyl and 2 ng/mL for LP-778902 and LP-951757.~AUC0-tlast was determined using non-compartmental analysis."|Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours), Day 2 (24 hours), Day 3 (48 hours) and Day 4 (72 hours)|The PK population included all subjects who received the single oral dose of study drug and had no major protocol deviations affecting the PK variables and for whom the renal function group was assessable and who had a sufficient number of plasma concentrations to estimate the main PK parameters.|||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2529453|NCT03442725|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Total Telotristat Ethyl, LP-778902 and LP-951757|"Blood samples were collected to determine plasma levels of telotristat ethyl, its active metabolite LP-778902 (also known as telotristat) and the inactive metabolite LP-951757 using a validated, specific and sensitive LC-MS/MS bioanalytical method with a LOQ of 0.5 ng/mL for telotristat ethyl and 2 ng/mL for LP-778902 and LP-951757.~AUC0-inf was determined using non-compartmental analysis."|Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours), Day 2 (24 hours), Day 3 (48 hours) and Day 4 (72 hours)|The PK population included all subjects who received the single oral dose of study drug and had no major protocol deviations affecting the PK variables and for whom the renal function group was assessable and who had a sufficient number of plasma concentrations to estimate the main PK parameters.|||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2529454|NCT03442725|Primary|Apparent Terminal Elimination Half-Life (t1/2) of Total Telotristat Ethyl, LP-778902 and LP-951757|"Blood samples were collected to determine plasma levels of telotristat ethyl, its active metabolite LP-778902 (also known as telotristat) and the inactive metabolite LP-951757 using a validated, specific and sensitive LC-MS/MS bioanalytical method with a LOQ of 0.5 ng/mL for telotristat ethyl and 2 ng/mL for LP-778902 and LP-951757.~T1/2 was determined using non-compartmental analysis."|Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours), Day 2 (24 hours), Day 3 (48 hours) and Day 4 (72 hours)|The PK population included all subjects who received the single oral dose of study drug and had no major protocol deviations affecting the PK variables and for whom the renal function group was assessable and who had a sufficient number of plasma concentrations to estimate the main PK parameters.|||hours||Standard Deviation|Mean
2529455|NCT03442725|Primary|Time to Maximum Observed Plasma Concentration (Tmax) of Total Telotristat Ethyl, LP-778902 and LP-951757|"Blood samples were collected to determine plasma levels of telotristat ethyl, its active metabolite LP-778902 (also known as telotristat) and the inactive metabolite LP-951757 using a validated, specific and sensitive LC-MS/MS bioanalytical method with a LOQ of 0.5 ng/mL for telotristat ethyl and 2 ng/mL for LP-778902 and LP-951757.~Tmax was determined using non-compartmental analysis."|Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours), Day 2 (24 hours), Day 3 (48 hours) and Day 4 (72 hours)|The PK population included all subjects who received the single oral dose of study drug and had no major protocol deviations affecting the PK variables and for whom the renal function group was assessable and who had a sufficient number of plasma concentrations to estimate the main PK parameters.|||hours||Full Range|Median
2529456|NCT03442725|Primary|Maximum Plasma Concentration (Cmax) of Total Telotristat Ethyl, LP-778902 and LP-951757|"Blood samples were collected to determine plasma levels of telotristat ethyl, its active metabolite LP-778902 (also known as telotristat) and the inactive metabolite LP-951757 using a validated, specific and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) bioanalytical method with a lower limit of quantitation (LOQ) of 0.5 nanograms (ng)/mL for telotristat ethyl and 2 ng/mL for LP-778902 and LP-951757.~Cmax was determined using non-compartmental analysis."|Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours), Day 2 (24 hours), Day 3 (48 hours) and Day 4 (72 hours)|The pharmacokinetic (PK) population included all subjects who received the single oral dose of study drug and had no major protocol deviations affecting the PK variables and for whom the renal function group was assessable and who had a sufficient number of plasma concentrations to estimate the main PK parameters.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2546641|NCT02918552|Other Pre-specified|Cognitive Function|Change in pre and post scores on the Montreal Cognitive Assessment|Week 2(pre drug) to Week 10( post drug); approx. 8 weeks|||||||
2529458|NCT03442699|Primary|Suicidal Ideation Intensity as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Intensity Subscale.|The CSSRS intensity subscale measures frequency, duration, controllability, deterrents, and reasons for suicidal ideation. The scale ranges from 2-25 with higher scores indicating more severe suicidal ideation.|Pre-treatment, after treatment which was an average of 16 days, and through follow up, an average of 3 months post-treatment|On participant was lost to follow-up and did not complete the 3 month follow-up assessment|||score on a scale||Standard Deviation|Mean
2529459|NCT03442036|Secondary|Opioid Consumption|Opioid consumption will be noninferior within the first 2 days following foot/ankle surgery with a suture-method compared with a through-the-needle perineural catheter when used for a continuous popliteal-sciatic nerve block to provide postoperative analgesia (cumulative dose).|first two postoperative days||||mg Oxycodone||Inter-Quartile Range|Mean
2529460|NCT03442036|Secondary|Catheter Dislodgment.|We will also test for noninferiority of the suture method to the through-the-needle perineural catheter on gross catheter dislodgment using a 1-tailed noninferiority test.|first two postoperative days||||Participants|||Count of Participants
2529461|NCT03442036|Primary|Average Pain Level on Numeric Rating Scale With 0 = no Pain and 10 = Worst Imaginable Pain (Units on a Scale)|"Surgical pain will be noninferior within the first 2 days following foot/ankle surgery with a suture-method compared with a through-the-needle perineural catheter when used for a continuous popliteal-sciatic nerve block to provide postoperative analgesia (the mean average pain measured daily with a Numeric Rating Scale)."|first two postoperative days||||Pain (NRS)||Standard Deviation|Mean
2529462|NCT03441984|Secondary|Change From Baseline in Temperature in Part 2|Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2|All Participants Population.|||Degree celsius||Standard Deviation|Mean
2529463|NCT03441984|Secondary|Change From Baseline in Pulse Rate in Part 2|Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2|All Participants Population.|||Beats per minute||Standard Deviation|Mean
2529464|NCT03441984|Secondary|Change From Baseline in SBP and DBP of Part 2|Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2|All Participants Population.|||Millimeters of mercury||Standard Deviation|Mean
2529465|NCT03441984|Secondary|Change From Baseline in Temperature of Part 1|Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2|All Participants Population.|||Degree celsius||Standard Deviation|Mean
2529466|NCT03441984|Secondary|Change From Baseline in Pulse Rate of Part 1|Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2|All Participants Population.|||Beats per minute||Standard Deviation|Mean
2529467|NCT03441984|Secondary|Change From Baseline in SBP and DBP of Part 1|Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1, pre-dose), Day 1- 4 hours and Day 2|All Participants Population.|||Millimeters of mercury||Standard Deviation|Mean
2529468|NCT03441984|Secondary|Absolute Values for Temperature in Part 2|Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest.|Day 1 at 4 hours post intervention dose and Day 2 of each treatment period|All Participants Population.|||Degree celsius||Standard Deviation|Mean
2529469|NCT03441984|Secondary|Absolute Values for Pulse Rate in Part 2|Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest.|Day 1 at 4 hours post intervention dose and Day 2 of each treatment period|All Participants Population.|||Beats per minute||Standard Deviation|Mean
2529470|NCT03441984|Secondary|Absolute Values for SBP and DBP of Part 2|Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.|Day 1 at 4 hours post intervention dose and Day 2 of each treatment period|All Participants Population.|||Millimeters of mercury||Standard Deviation|Mean
2529471|NCT03441984|Secondary|Absolute Values for Temperature in Part 1|Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest.|Day 1 at 4 hours post intervention dose and Day 2 of each treatment period|All Participants Population.|||Degree celsius||Standard Deviation|Mean
2529472|NCT03441984|Secondary|Absolute Values for Pulse Rate in Part 1|Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest.|Day 1 at 4 hours post intervention and Day 2 of each treatment period|All Participants Population.|||Beats per minute||Standard Deviation|Mean
2529473|NCT03441984|Secondary|Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Part 1|Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.|Day 1 at 4 hours post intervention and Day 2 of each treatment period|All Participants Population.|||Millimeters of mercury||Standard Deviation|Mean
2529474|NCT03441984|Secondary|Number of Participants With Abnormal ECG Findings in Part 2|Full 12-lead ECGs were recorded with the participant in a supine position. Absolute QTc Interval: >450, absolute PR Interval: <110 and Absolute QRS Interval: <75 were considered to be potential clinically significant ECG finding. The number of participants with abnormal clinically significant ECG findings are presented|Baseline (Day -1)|All Participants Population.|||Participants|||Count of Participants
2529475|NCT03441984|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Part 1|Full 12-lead ECGs were recorded with the participant in a supine position. Absolute QTc Interval: >450, absolute PR Interval: <110 and Absolute QRS Interval: <75 were considered to be potential clinically significant ECG finding. The number of participants with abnormal clinically significant ECG findings are presented.|Baseline (Day -1)|All Participants Population.|||Participants|||Count of Participants
2529476|NCT03441984|Secondary|Number of Participants With Urine Potential of Hydrogen (pH)-Part 2|Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).|Up to Day 33|All Participants Population.|||Participants|||Count of Participants
2529477|NCT03441984|Secondary|Number of Participants With Abnormal Urinalysis Parameter in Part 2|The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as increased, decreased, increase to trace, 1+ and 3+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented.|Up to Day 33|All Participants Population.|||Participants|||Count of Participants
2529478|NCT03441984|Secondary|Number of Participants With Urine Potential of Hydrogen (pH)-Part 1|Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).|Up to Day 33|All Participants Population.|||Participants|||Count of Participants
2529479|NCT03441984|Secondary|Number of Participants With Abnormal Urinalysis Parameter in Part 1|The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as increased, decreased, increase to trace, 1+ and 3+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented.|Up to Day 33|All Participants Population.|||Participants|||Count of Participants
2529480|NCT03441984|Secondary|Change From Baseline Values for Hemoglobin in Part 2|Blood samples were collected for the analysis hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||Gram per liter||Standard Deviation|Mean
2529481|NCT03441984|Secondary|Change From Baseline Values for Hemocrit in Part 2|Blood samples were collected for the analysis hemocrit in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||Percentage of red blood cells in blood||Standard Deviation|Mean
2529482|NCT03441984|Secondary|Change From Baseline Values for Erythrocytes in Part 2|Blood samples were collected for the analysis erythrocytes in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||10^12 cells per liter||Standard Deviation|Mean
2529483|NCT03441984|Secondary|Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 2|Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||Femtoliter||Standard Deviation|Mean
2529484|NCT03441984|Secondary|Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2|Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||Picograms||Standard Deviation|Mean
2529485|NCT03441984|Secondary|Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2|Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 2 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||10^9 cells per liter||Standard Deviation|Mean
2529486|NCT03441984|Secondary|Change From Baseline Values for Hemoglobin in Part 1|Blood samples were collected for the analysis hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||Grams per liter||Standard Deviation|Mean
2529487|NCT03441984|Secondary|Change From Baseline Values for Hemocrit in Part 1|Blood samples were collected for the analysis hemocrit in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||Percentage of red blood cells in blood||Standard Deviation|Mean
2529488|NCT03441984|Secondary|Change From Baseline Values for Erythrocytes in Part 1|Blood samples were collected for the analysis erythrocytes in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||10^12 cells per liter||Standard Deviation|Mean
2529489|NCT03441984|Secondary|Change From Baseline Values for Erythrocyte Mean Corpuscular Volume in Part 1|Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||Femtoliter||Standard Deviation|Mean
2529771|NCT03430050|Primary|Change in Salivary Progesterone Level|Participants took progesterone or placebo for 5 days. Salivary progesterone was measured each day. Change score was calculating by subtracting Day 1 progesterone levels from Day 5 progesterone levels.|Day 1 and Day 5||||pg/ml||Standard Error|Mean
2529490|NCT03441984|Secondary|Change From Baseline Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1|Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||Picograms||Standard Deviation|Mean
2529491|NCT03441984|Secondary|Change From Baseline Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1|Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 1 at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||10^9 cells per liter||Standard Deviation|Mean
2529492|NCT03441984|Secondary|Absolute Values for Hemoglobin in Part 2|Blood samples were collected for the analysis hemoglobin in Part 2 at indicated time points.|Day 2 of each treatment period|All Participants Population.|||Grams per liter||Standard Deviation|Mean
2529493|NCT03441984|Secondary|Absolute Values for Hemocrit in Part 2|Blood samples were collected for the analysis hemocrit in Part 2 at indicated time points.|Day 2 of each treatment period|All Participants Population.|||Percentage of red blood cells in blood||Standard Deviation|Mean
2529494|NCT03441984|Secondary|Absolute Values for Erythrocytes in Part 2|Blood samples were collected for the analysis erythrocytes in Part 2 at indicated time points.|Day 2 of each treatment period|All Participants Population.|||10^12 cells per liter||Standard Deviation|Mean
2529495|NCT03441984|Secondary|Absolute Values for Erythrocyte Mean Corpuscular Volume in Part 2|Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points.|Day 2 of each treatment period|All Participants Population.|||Femtoliter||Standard Deviation|Mean
2529496|NCT03441984|Secondary|Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 2|Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 2 at indicated time points.|Day 2 of each treatment period|All Participants Population.|||Picograms||Standard Deviation|Mean
2529497|NCT03441984|Secondary|Absolute Values for Hematology Parameters Including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 2|Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 2 at indicated time points.|Day 2 of each treatment period|All Participants Population.|||10^9 cells per liter||Standard Deviation|Mean
2529498|NCT03441984|Secondary|Absolute Values for Hemoglobin in Part 1|Blood samples were collected for the analysis hemoglobin in Part 1 at indicated time points.|Day 2 of each treatment period|All Participants Population.|||Grams per liter||Standard Deviation|Mean
2529499|NCT03441984|Secondary|Absolute Values for Hemocrit in Part 1|Blood samples were collected for the analysis hemocrit in Part 1 at indicated time points.|Day 2 of each treatment period|All Participants Population.|||Percentage of red blood cells in blood||Standard Deviation|Mean
2529500|NCT03441984|Secondary|Absolute Values for Erythrocytes in Part 1|Blood samples were collected for the analysis erythrocytes in Part 1 at indicated time points.|Day 2 of each treatment period|All Participants Population.|||10^12 cells per liter||Standard Deviation|Mean
2529501|NCT03441984|Secondary|Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1|Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points.|Day 2 of each treatment period|All Participants Population.|||Femtoliter||Standard Deviation|Mean
2529502|NCT03441984|Secondary|Absolute Values for Erythrocyte Mean Corpuscular Hemoglobin in Part 1|Blood samples were collected for the analysis erythrocyte mean corpuscular hemoglobin in Part 1 at indicated time points.|Day 2 of each treatment period|All Participants Population.|||Picograms||Standard Deviation|Mean
2529503|NCT03441984|Secondary|Absolute Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelets in Part 1|Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, leukocytes and platelets in Part 1 at indicated time points.|Day 2 of each treatment period|All Participants Population.|||10^9 cells per liter||Standard Deviation|Mean
2529504|NCT03441984|Secondary|Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin|Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||Micromoles per liter||Standard Deviation|Mean
2529505|NCT03441984|Secondary|Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein|Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||Grams per liter||Standard Deviation|Mean
2529506|NCT03441984|Secondary|Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK|Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||International units per liter||Standard Deviation|Mean
2529507|NCT03441984|Secondary|Change From Baseline in Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea|Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||Millimoles per liter||Standard Deviation|Mean
2529772|NCT03429712|Primary|Image Noise||Up to 5 minutes|Data not collected.||||||
2553723|NCT02770625|Secondary|Platelet Counts [10^3 Platelets/uL]||from baseline to Week 24||||10^3 platelets/uL||Standard Deviation|Mean
2529508|NCT03441984|Secondary|Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin|Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||Micromoles per liter||Standard Deviation|Mean
2529509|NCT03441984|Secondary|Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein|Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||Grams per liter||Standard Deviation|Mean
2529510|NCT03441984|Secondary|Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: ALT, ALP, AST and CPK|Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||International units per Liter||Standard Deviation|Mean
2529511|NCT03441984|Secondary|Change From Baseline in Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea|Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and Day 2|All Participants Population.|||Millimoles per liter||Standard Deviation|Mean
2529512|NCT03441984|Secondary|Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Bilirubin, Creatinine and Direct Bilirubin|Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin.|Day 2 of each treatment period|All Participants Population.|||Micromoles per liter||Standard Deviation|Mean
2529513|NCT03441984|Secondary|Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Albumin and Protein|Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein.|Day 2 of each treatment period|All Participants Population.|||Grams per liter||Standard Deviation|Mean
2529514|NCT03441984|Secondary|Absolute Values for Clinical Chemistry Parameters Measured in Part 2: ALT, ALP, AST and CPK|Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK.|Day 2 of each treatment period|All Participants Population.|||International units per liter||Standard Deviation|Mean
2529515|NCT03441984|Secondary|Absolute Values for Clinical Chemistry Parameters Measured in Part 2: Glucose, Calcium, Potassium, Sodium and Urea|Blood samples were collected for the analysis of clinical chemistry parameters including glucose, calcium, potassium, sodium and urea.|Day 2 of each treatment period|All Participants Population.|||Millimoles per liter||Standard Deviation|Mean
2529516|NCT03441984|Secondary|Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Bilirubin, Creatinine and Direct Bilirubin|Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin.|Day 2 of each treatment period|All Participants Population.|||Micromoles per liter||Standard Deviation|Mean
2529517|NCT03441984|Secondary|Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Albumin and Protein|Blood samples were collected for the analysis of clinical chemistry parameters including albumin and protein.|Day 2 of each treatment period|All Participants Population.|||Grams per liter||Standard Deviation|Mean
2529518|NCT03441984|Secondary|Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotranferase (AST) and Creatinine Phosphokinase (CPK)|Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CPK.|Day 2 of each treatment period|All Participants Population.|||International units per Liter||Standard Deviation|Mean
2529519|NCT03441984|Secondary|Absolute Values for Clinical Chemistry Parameters Measured in Part 1: Glucose, Calcium, Potassium, Sodium and Urea|Blood samples were collected for the analysis of clinical chemistry parameters which included glucose, calcium, potassium, sodium and urea. All participants population included all participants who received at least one dose of study medication. This population corresponded to all participants enrolled.|Day 2 of each treatment period|All Participants Population.|||Millimoles per liter||Standard Deviation|Mean
2529520|NCT03441984|Secondary|Number of Participants With AEs and Serious Adverse Events SAEs in Part 2|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement.|Up to Day 33|Safety Population.|||Participants|||Count of Participants
2529521|NCT03441984|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Part 1|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety population comprised of all participants enrolled in the study, who took at least one dose of study treatment.|Up to Day 33|Safety Population|||Participants|||Count of Participants
2529522|NCT03441984|Secondary|T½ of 3TC in Plasma in Part 2|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Hours||Geometric Coefficient of Variation|Geometric Mean
2529523|NCT03441984|Secondary|Ct of 3TC in Plasma in Part 2|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529524|NCT03441984|Secondary|C24 of 3TC in Plasma in Part 2|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period|PK population|||Nanograms per millilter||Geometric Coefficient of Variation|Geometric Mean
2529525|NCT03441984|Secondary|Vz/F of 3TC in Plasma in Part 2|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Liters||Geometric Coefficient of Variation|Geometric Mean
2529526|NCT03441984|Secondary|CL/F of 3TC in Plasma in Part 2|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population. Only those participants with data available at the specified time points were analyzed.|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2529527|NCT03441984|Secondary|Tlast of 3TC in Plasma in Part 2|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Hours||Full Range|Median
2529528|NCT03441984|Secondary|Tmax of 3TC in Plasma in Part 2|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Hours||Full Range|Median
2529529|NCT03441984|Secondary|AUC (0-24) of 3TC in Plasma in Part 2|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period|PK population|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529530|NCT03441984|Secondary|Tlag of DTG in Plasma in Part 2|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Hours||Full Range|Median
2529531|NCT03441984|Secondary|T½ of DTG in Plasma in Part 2|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Hours||Geometric Coefficient of Variation|Geometric Mean
2529532|NCT03441984|Secondary|Ct of DTG in Plasma in Part 2|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529533|NCT03441984|Secondary|C24 of DTG in Plasma in Part 2|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period|PK population|||Nanograms per millilter||Geometric Coefficient of Variation|Geometric Mean
2529534|NCT03441984|Secondary|Vz/F of DTG in Plasma in Part 2|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Liters||Geometric Coefficient of Variation|Geometric Mean
2529535|NCT03441984|Secondary|CL/F of DTG in Plasma in Part 2|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2529536|NCT03441984|Secondary|Tlast of DTG in Plasma in Part 2|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Hours||Full Range|Median
2546642|NCT02918552|Other Pre-specified|Cardiopulmonary Exercise Testing; nCPET|Non-invasive cardiopulmonary exercise testing|Week 2(pre drug) to Week 10( post drug); approx. 8 weeks|||||||
2529537|NCT03441984|Secondary|Tmax of DTG in Plasma in Part 2|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Hours||Full Range|Median
2529538|NCT03441984|Secondary|AUC (0-24) of DTG in Plasma in Part 2|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period|PK population|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529539|NCT03441984|Secondary|T½ of 3TC in Plasma in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Hours||Geometric Coefficient of Variation|Geometric Mean
2529540|NCT03441984|Secondary|Ct of 3TC in Plasma in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529541|NCT03441984|Secondary|C24 of 3TC in Plasma in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period|PK population|||Nanograms per millilter||Geometric Coefficient of Variation|Geometric Mean
2529542|NCT03441984|Secondary|Vz/F of 3TC in Plasma in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Liters||Geometric Coefficient of Variation|Geometric Mean
2529543|NCT03441984|Secondary|CL/F of 3TC in Plasma in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2529544|NCT03441984|Secondary|Tlast of 3TC in Plasma in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Hours||Full Range|Median
2529545|NCT03441984|Secondary|Tmax of 3TC in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Hours||Full Range|Median
2529546|NCT03441984|Secondary|AUC(0-24) of 3TC in Plasma in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period|PK population|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529547|NCT03441984|Secondary|T½ of ABC in Plasma in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Hours||Geometric Coefficient of Variation|Geometric Mean
2529548|NCT03441984|Secondary|Ct of ABC in Plasma in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529549|NCT03441984|Secondary|C24 of ABC in Plasma in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period|PK population|||Nanograms per millilter||Geometric Coefficient of Variation|Geometric Mean
2529550|NCT03441984|Secondary|Vz/F of ABC in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Liters||Geometric Coefficient of Variation|Geometric Mean
2529773|NCT03429556|Secondary|Number of Doses of Rescue Medications Used||Up to 96 hours postsurgery|mITT population included all randomized and treated participants with at least one post-injection pain score.|||doses||Standard Deviation|Mean
2529551|NCT03441984|Secondary|CL/F of ABC in Plasma in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2529552|NCT03441984|Secondary|Tlast of ABC in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Hours||Full Range|Median
2529553|NCT03441984|Secondary|Tmax of ABC in Plasma in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Hours||Full Range|Median
2529554|NCT03441984|Secondary|AUC(0-24) of ABC in Plasma in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period|PK population|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529555|NCT03441984|Secondary|Lag Time for Absorption (Tlag) of DTG in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Hours||Full Range|Median
2529556|NCT03441984|Secondary|Terminal Elimination Phase Half-life (t½) of DTG in Plasma in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Hours||Geometric Coefficient of Variation|Geometric Mean
2529557|NCT03441984|Secondary|Last Observed Quantifiable Concentration (Ct) of DTG in Plasma in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529558|NCT03441984|Secondary|Observed Concentration at 24 Hours Postdose (C24) of DTG in Plasma in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period|PK population|||Nanograms per millilter||Geometric Coefficient of Variation|Geometric Mean
2529559|NCT03441984|Secondary|Apparent Volume of Distribution (Vz/F) of DTG in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Liters||Geometric Coefficient of Variation|Geometric Mean
2529560|NCT03441984|Secondary|Apparent Oral Clearance (CL/F) of DTG in Plasma in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2529561|NCT03441984|Secondary|Time of Last Quantifiable Concentration (Tlast) of DTG in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population.|||Hours||Full Range|Median
2529562|NCT03441984|Secondary|Time to Maximum Concentration (Tmax) of DTG in Plasma in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population.|||Hours||Full Range|Median
2529563|NCT03441984|Secondary|AUC From Time of Dose to 24 Hours (AUC[0-24]) of DTG in Part 1|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 and 24 hours post-dose of each treatment period|PK population.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529564|NCT03441984|Primary|Cmax in Part 2 of 3TC|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529565|NCT03441984|Primary|AUC(0-t) in Part 2 of 3TC|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529566|NCT03441984|Primary|AUC(0-inf) in Part 2 of 3TC|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529567|NCT03441984|Primary|Cmax in Part 2 of DTG in Plasma|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529568|NCT03441984|Primary|AUC(0-t) in Part 2 of DTG|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK Population.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529569|NCT03441984|Primary|AUC(0-inf) in Part 2 of DTG in Plasma|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 2. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK Population|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529570|NCT03441984|Primary|Cmax in Part 1 of 3TC|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK Population.|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529571|NCT03441984|Primary|AUC (0-t) in Part 1 of 3TC|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529572|NCT03441984|Primary|AUC(0-inf) in Part 1 of 3TC|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of 3TC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK Population|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529573|NCT03441984|Primary|Cmax in Part 1 of ABC in Plasma|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population.|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529574|NCT03441984|Primary|AUC(0-t) in Part 1 of ABC|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK Population|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529575|NCT03441984|Primary|AUC(0-inf) in Part 1 of ABC|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of ABC in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK Population|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529576|NCT03441984|Primary|Maximum Observed Concentration (Cmax) in Part 1 of DTG in Plasma|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. PK analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population.|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529597|NCT03441633|Primary|Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit|Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included alcoholic habit.|Day 1|Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.|||Participants|||Count of Participants
2529577|NCT03441984|Primary|AUC From Time of Dose to Last Measurable Concentration (AUC[0-t]) in Part 1 of DTG|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Statistics has been presented on geometric LS means.|Pre-dose,15 and 30 minutes,1 ,1.5 ,2 ,2.5 ,3 ,4 ,5 ,6 ,8 ,12 ,16 ,24 ,48 and 72 hours post-dose of each treatment period|PK population.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529578|NCT03441984|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time of Dose Extrapolated to Infinity (AUC[0-inf]) in Part 1 of DTG|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters of DTG in Part 1. Pharmacokinetic analysis was conducted using standard non-compartmental methods. PK population comprised of participants in the all participants population (participants who took at least 1 dose of study medication) for whom PK sample was obtained and who had evaluable PK assay results. Statistics has been presented on geometric least square (LS) means.|Pre-dose, 15 and 30 minutes, 1 , 1.5 , 2 , 2.5 , 3 , 4 , 5 , 6 , 8 , 12 , 16 , 24 , 48 and 72 hours post-dose of each treatment period|PK population.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2529579|NCT03441789|Secondary|Global Percent Improvement in Dermatologic Quality of Life Index (DLQI) at Week 4, 12, and 16|The DLQI is a 10-question tool completed by subjects to ascertain the severity of disease based on the extent to which disease interferes with daily life. Each question is scored according to the response wherein Very Much =3, A lot=2, A little=1 and Not at all=0. The sum of all responses is then recorded on a scale from 0 to 30, lower scores indicating better quality of life.|4 weeks, 12, weeks, 16 weeks||||score on a scale||Standard Deviation|Mean
2529580|NCT03441789|Secondary|Global Improvement in Itch Visual Analogue Scale (VAS) at Week 4,12 and 16|The Itch VAS (Visual Analog Scale) is completed by subjects wherein they are asked to rate the severity of their itching over the last 48 hours on a scale from 0 (no itching) to 10 (unbearable itching); low scores indicate a better outcome.|4 weeks, 12 weeks, 16 weeks||||scale unit||Standard Deviation|Mean
2529581|NCT03441789|Secondary|Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16|The Investigator will rate the severity of of disease based on the assessment of 3 clinical signs (erythema, induration, desquamation) wherein 0=no signs of psoriasis, 1=almost clear, 2=mild, 3=moderate, 4=severe|4 weeks, 12 weeks, 16 weeks||||Participants|||Count of Participants
2529582|NCT03441789|Secondary|Percent of Subjects With PASI 90 and 100 at Week 16|Psoriasis Area & Severity Index (PASI) is a tool used to measure the severity of psoriasis. It combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.)|16 weeks||||Participants|||Count of Participants
2529583|NCT03441789|Secondary|Percent of Subjects With PASI 75 at Week 4 and Week 12|Psoriasis Area & Severity Index (PASI) is a tool used to measure the severity of psoriasis. It combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.)|4 weeks, 12 weeks||||Participants|||Count of Participants
2529584|NCT03441789|Primary|Percent of Subjects With a Psoriasis Assessment and Severity Index (PASI) 75 at Week 16|PASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.) The body is divided into 4 sections: head (10% of total body surface area,) arms (20%,) trunk(30%,) and legs (40%.) Each of these is scored by itself and the 4 scores then combined to obtain thePASI. For each body area, the percent of skin area involved is estimated and graded based on this value (0=0% of area involved, 1=<10%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%.) Within each area, the severity of disease is based on 3 clinical signs: erythema or redness, induration or thickness, and desquamation or scaliness. Each is graded on a scale from 0(none) to 4(maximum.) The sum of all 3 parameters is calculated for each body section, multiplied by the area score for that section and then multiplied by the weight of that section (.1for head, .2 arms, .3 trunk and .4 legs)|16 weeks||||Participants|||Count of Participants
2529585|NCT03441633|Primary|Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA|TTR was defined as the duration of time in which the participant's INR values were within a desired range (2 to 3). INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (2<INR<3); and risk of hemorrhages (INR>3).|Up to 12 months after date of first prescription|"Study population included all participants with a first-recorded prescription of VKA for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here N signifies number of participants evaluable for the specified outcome measure."|||days||Inter-Quartile Range|Median
2529586|NCT03441633|Primary|International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA|INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (2<INR<3); and risk of hemorrhages (INR>3).|Up to 12 months after date of first prescription|"Study population included all participants with a first-recorded prescription of VKA for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here N signifies number of participants evaluable for the specified outcome measure."|||ratio||Standard Deviation|Mean
2529587|NCT03441633|Primary|Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)|NDDD was a measure that represented the average daily maintenance dose for the main indication of a drug.|Up to 12 months after date of first prescription|"Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here N signifies number of participants evaluable for the specified outcome measure."|||milligrams per day||Inter-Quartile Range|Median
2529633|NCT03439072|Secondary|Glucose Tmax|Time to maximum concentration of plasma glucose. Blood samples for assessment of blood glucose concentration were collected every 5 minutes post-dose to 90 minutes, and then at 120, 150 and 180 minutes post dose.|0 to 180 minutes post dose|Intent to treat analysis population|||minutes||Standard Deviation|Mean
2529588|NCT03441633|Primary|Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year|Discontinuation rate was defined as the lack of subsequent prescription of the index drugs within 2 months after last supply day of the last prescription. It was analyzed by calculating the treatment withdrawal or switch rate.|Up to 12 months after date of first prescription|"Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here N signifies number of participants evaluable for the specified outcome measure."|||Participants|||Count of Participants
2529589|NCT03441633|Primary|Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR)|MPR was one of the methods of measuring adherence and was defined as the ratio of all days supply to elapsed days, during the 12-month observation period. All days supply defined as sum of number of days supply between the start date and last prescription dispensed. Elapsed days defined as number of days between the start date and the last prescription dispensed. There were three categories of adherence: poor defined as <80% of MPR, good defined as between 80% and 120% of MPR and over adherence defined as >120% of MPR.|Up to 12 months after date of first prescription|"Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here N signifies number of participants evaluable for the specified outcome measure."|||Participants|||Count of Participants
2529590|NCT03441633|Primary|Number of Participants by Comedications|Comedication was defined as the second or alternative medication used to relieve the side-effects of another medicine.|Up to 30 days after date of first prescription|Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.|||Participants|||Count of Participants
2529591|NCT03441633|Primary|Risk of Thromboembolic Events: CHA2DS2Vasc Score|Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHA2DS2Vasc score. CHA2DS2Vasc score was assessed by combining score of 8 risk factors (female, >=65 and <75 years, congestive heart failure history, hypertension history, diabetes mellitus history, vascular disease history, age >=75 years and stroke/TIA symptoms previously). Total CHA2DS2Vasc score ranged from 0-9 where 0=low risk and 9=high risk of stroke.|Up to 12 months prior to enrollment|Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.|||stroke risk per year||Standard Deviation|Mean
2529592|NCT03441633|Primary|Risk of Thromboembolic Events: CHADS2 Score|Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHADS2 score. CHADS2 score was assessed by combining score of 5 risk factors (congestive heart failure history, hypertension history, age >=75 years, diabetes mellitus history and stroke/transient ischemic attack symptoms previously). Total CHADS2 score ranged from 0-6 where 0 =low risk and 6 =high risk of stroke.|Up to 12 months prior to enrollment|Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.|||stroke risk per year||Standard Deviation|Mean
2529593|NCT03441633|Primary|Risk of Bleeding Events: HAS-BLED Score|Risk of bleeding events was assessed by using HAS-BLED score. HAS-BLED was a scoring system that was developed to assess 1 year risk of occurrence of major hemorrhage. HAS-BLED score was assessed by combining score of 9 risk factors: hypertension history, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol or drug usage history. The total score ranged from 0 to 9 where 0 = low risk of bleed per 100 participants-year and >3 = high risk of bleed per 100 participants-year.|Up to 12 months prior to enrollment|Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.|||bleed per 100 participants-year||Standard Deviation|Mean
2529594|NCT03441633|Primary|Number of Participants by Comorbidity|Comorbidity was defined as the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder.|Up to 12 months after date of first prescription|Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.|||Participants|||Count of Participants
2529595|NCT03441633|Primary|Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)|Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included BMI. BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m^2).|Day 1|Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.|||Participants|||Count of Participants
2529596|NCT03441633|Primary|Number of Participants by Their Sociodemographic Characteristics: MEDEA|Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included MEDEA. MEDEA was a deprivation index that was associated with overall mortality in urban areas. It included factors like job, education, housing conditions and single parent homes. The MEDEA index was categorized in quintiles for urban areas, with quintile 1 corresponding to the least deprived population and quintile 5, the most deprived.|Day 1|"Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF. Here, Overall Number of Participants Analyzed (N) signifies participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2529634|NCT03439072|Secondary|Glucose Cmax|Maximum concentration of plasma glucose.|0 to 180 minutes post dose - Blood samples for assessment of blood glucose concentration were collected every 5 minutes post-dose to 90 minutes, and then at 120, 150 and 180 minutes post dose.|Intent to treat analysis population|||mg/dL||Standard Deviation|Mean
2529598|NCT03441633|Primary|Number of Participants by Their Sociodemographic Characteristics: Smoking Habit|Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included smoking habit.|Day 1|Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.|||Participants|||Count of Participants
2529599|NCT03441594|Secondary|Grit|Assessed using the 8-item Short Grit Scale, which measures trait-level perseverance and passion for long-term goals. Scores range from 1 (not at all gritty) to 5 (extremely gritty).|Through study completion, an average of 1 hour and 30 minutes at Study Visit 1||||score on a scale||Standard Deviation|Mean
2529600|NCT03441594|Primary|Delay Discounting|Assessed via the 27-Item Monetary Choice Questionnaire, which measures bias toward smaller, immediate rewards versus larger, delayed rewards. This questionnaire presents participants with a set of 27 choices between smaller, immediate monetary rewards and larger, delayed monetary rewards. Participants who discount the value of the delayed rewards more steeply are considered to be more impulsive. An estimate of a participant's discounting rate (k) is calculated from the pattern of choices. Values of k range from 0.00016 (ln transformation -8.74) to 0.25 (ln transformation -1.39), with higher values indicating a greater preference for smaller, immediate rewards over larger, delayed rewards. K tends to be skewed, so a natural log (ln) transformation is utilized to approximate a normal distribution for statistical analyses.|Through study completion, an average of 1 hour and 30 minutes at Study Visit 1||||score on a scale (natural log)||Standard Deviation|Mean
2529601|NCT03440918|Secondary|Number of Participants Whose Provider Adhered to the Procalcitonin-guided Algorithm|Rate of clinical provider compliance with adherence to suggested antibiotic escalation or de-escalation made by the antimicrobial stewardship team based on procalcitonin levels will be tracked|up to 5 days|intention to treat (all participants assigned to Baseline Antimicrobial Stewardship or Procalcitonin-Guided Antimicrobial Stewardship)|||Participants|||Count of Participants
2529602|NCT03440918|Secondary|Antibiotic Cost|Cost of antibiotic course will be obtained from hospital billing data|up to 14 days|intention to treat (all participants assigned to Baseline Antimicrobial Stewardship or Procalcitonin-Guided Antimicrobial Stewardship)|||dollars|||Number
2529603|NCT03440918|Secondary|Infection With a Multi-drug Resistant Organism|Identification/growth of a multi-drug resistant organism from a sterile culture site. Multi-drug resistant organisms will be defined as methicillin-resistant S. aureus, vancomycin-resistant Enterococcus, 3rd generation cephalosporin non-susceptible Enterobacteriaceae, multi-drug resistant Pseudomonas aeruginosa [resistant to aminoglycosides, cephalosporins, floroquinolones and carbepenems], carbepenem-resistant Acinetobacter, and Candida spp obtained from otherwise sterile sites [i.e. blood or urine cultures]|up to 30 days|intention to treat (all participants assigned to Baseline Antimicrobial Stewardship or Procalcitonin-Guided Antimicrobial Stewardship)|||Participants|||Count of Participants
2529604|NCT03440918|Secondary|Number of Participants With Antibiotic-associated Complications|Antibiotic-associated complications including rash, neutropenia, thrombocytopenia, acute kidney injury [defined as increase in serum creatinine > 0.3 mg per dL or > 1.5-fold from baseline, or urine output < 0.5 mL per kg per hour for more than six hours], hepatotoxicity [defined as > 2-fold increase in alanine aminotransferase, ALT, or conjugated bilirubin], or C. difficile infection will be recorded|up to 14 days|intention to treat (all participants assigned to Baseline Antimicrobial Stewardship or Procalcitonin-Guided Antimicrobial Stewardship)|||Participants|||Count of Participants
2529605|NCT03440918|Secondary|Ventilator Days|Days spent using invasive ventilation methods (not including supplementary oxygen via nasal cannula or Vapotherm support)|up to 14 days|intention to treat (all participants assigned to baseline antimicrobial stewardship or procalcitonin-guided antimicrobial stewardship)|||days||Inter-Quartile Range|Median
2529606|NCT03440918|Secondary|Length of Overall Hospital Stay|Hospital days admitted to the hospital|Until hospital discharge, an average of 7 days|intention to treat (all participants assigned to baseline antimicrobial stewardship or procalcitonin-guided antimicrobial stewardship)|||days||Inter-Quartile Range|Median
2529607|NCT03440918|Secondary|Length of Intensive Care Unit Stay|Hospital days spent in the intensive care unit|up to 14 days|intention to treat (all participants assigned to baseline antimicrobial stewardship or procalcitonin-guided antimicrobial stewardship)|||days||Inter-Quartile Range|Median
2529608|NCT03440918|Secondary|Re-initiation of Antibiotics for a Bacterial Infection|Re-initiation of any antibiotic for a proven or suspected bacterial infection|up to 30 days|intention to treat (all participants assigned to baseline antimicrobial stewardship or procalcitonin-guided antimicrobial stewardship)|||Participants|||Count of Participants
2529609|NCT03440918|Secondary|30-day Mortality|All-cause mortality|up to 30 days|intention to treat (all participants assigned to baseline antimicrobial stewardship or procalcitonin-guided antimicrobial stewardship)|||Participants|||Count of Participants
2529610|NCT03440918|Secondary|Number of Patients With an Antibiotic Change|Number of patients with an appropriate antibiotic escalation or de-escalation based on patient's clinical status and available supporting laboratory evidence, or lack thereof, of specific type of infection|up to 14 days|intention to treat (all participants assigned to baseline antimicrobial stewardship or procalcitonin-guided antimicrobial stewardship)|||Participants|||Count of Participants
2529611|NCT03440918|Secondary|Duration of Broad-spectrum Antibiotic Therapy|Defined as vancomycin, daptomycin, amikacin, ceftazidime, cefepime, piperacillin/tazobactam, aztreonam, carbapenems|up to14 days|intention to treat|||days||Inter-Quartile Range|Median
2529612|NCT03440918|Primary|Days of Antibiotic Therapy in the First 14 Days Following Randomization|Days of antibiotic therapy a participant receives following randomization will be measured|14 days|Intention to treat|||days||Inter-Quartile Range|Median
2529613|NCT03440619|Primary|RRp Arms of Sensor Accuracy|Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00013 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00013 RRp measurement for a number of samples. The average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms value.|1-5 hours||||respiration per minute (RPM)|||Number
2529614|NCT03440424|Secondary|CLu/F: Apparent Clearance Relative to the Unbound Plasma Concentration Based on AUCu of Lemborexant|Unbound fraction of drug in plasma was calculated as 100% - mean percent of lemborexant bound to plasma protein for each participant. Blood samples were analyzed for the amount of lemborexant in the plasma. Plasma concentration-time data were measured by validated LC-MS/MS method. Plasma PK data were analyzed using a non-compartmental method of analysis.|Day 1: Predose, 0.5 up to 312 hours postdose|The PK Analysis Set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least 1 PK parameter. Here “Overall number of participants analyzed” signifies participants who were evaluable for this outcome measure.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2529615|NCT03440424|Secondary|fu: Plasma Protein Unbound Fraction of Lemborexant and Its Metabolites M4, M9, and M10|Unbound fraction of drug in plasma was calculated as 100 percent (%) - mean percent of lemborexant and its metabolites M4, M9, and M10 bound to plasma protein for each participant. Blood samples were analyzed for the amount of lemborexant and its metabolites (M4, M9, M10) in the plasma. Plasma concentration-time data were measured by validated LC-MS/MS method. Plasma PK data were analyzed using a non-compartmental method of analysis.|Day 1: Predose, 0.5 up to 312 hours postdose|The PK Analysis Set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least 1 PK parameter.|||% (percent) unbound||Geometric Coefficient of Variation|Geometric Mean
2529616|NCT03440424|Secondary|MPR: Metabolite-to-Parent Ratios of AUC(0-inf) for Lemborexant's Metabolites M4, M9, and M10|The MPR is the ratio of AUC(0-inf) of the individual lemborexant metabolites (M4, M9, M10) to AUC(0-inf) of lemborexant, corrected for molecular weights. Blood samples were analyzed for the amount of lemborexant metabolites in the plasma. Plasma concentration-time data were measured by validated LC-MS/MS method. Plasma PK data were analyzed using a non-compartmental method of analysis.|Day 1: Predose, 0.5 up to 312 hours postdose|The PK Analysis Set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least 1 PK parameter. Here “Number analyzed” signifies participants who were evaluable for the outcome measure for each metabolite (M4, M9, and M10).|||ratio||Geometric Coefficient of Variation|Geometric Mean
2529617|NCT03440424|Secondary|Vz/F: Apparent Volume of Distribution of Lemborexant|The apparent volume of distribution gives information about amount of lemborexant distributed in body tissue rather than the blood/plasma. Vz/F for parent lemborexant only was calculated as Dose/(AUC0-inf multiplied by elimination rate constant[λz]). Area under the plasma concentration-time curve from time zero to infinity, calculated(AUC0-inf) as AUC0-t + AUCextra. AUCextra represents an extrapolated value obtained by Clast/λz, where Clast: plasma concentration at last sampling time point at which measured plasma concentration is at or above LLQ. λz is the elimination rate constant. Elimination rate constant obtained from linear regression of terminal phase of log transformed concentration-time data. A minimum of three points is required to calculate λz. Blood samples were analyzed for amount of lemborexant in plasma. Plasma concentration-time data were measured by validated LC-MS/MS method. Plasma PK data were analyzed using a non-compartmental method of analysis.|Day 1: Predose, 0.5 up to 312 hours postdose|The PK Analysis Set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least 1 PK parameter. Here “Overall number of participants analyzed” signifies participants who were evaluable for this outcome measure.|||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
2529618|NCT03440424|Secondary|CL/F: Apparent Total Body Clearance of Lemborexant|CL/F is the clearance for parent lemborexant only and was calculated as Dose/[AUC 0-inf]. Blood samples were analyzed for the amount of lemborexant in the plasma. Plasma concentration-time data were measured by validated LC-MS/MS method. Plasma PK data were analyzed using a non-compartmental method of analysis.|Day 1: Predose, 0.5 up to 312 hours postdose|The PK Analysis Set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least 1 PK parameter. Here “Overall number of participants analyzed” signifies participants who were evaluable for this outcome measure.|||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2529619|NCT03440424|Secondary|T1/2: Terminal Plasma Phase Half-life of Lemborexant and Its Metabolites M4, M9, M10|Terminal plasma half-life is the time required for plasma/blood concentration to decrease by 50%. This is not the time required to eliminate half the administered dose. Blood samples were analyzed for the amount of lemborexant and its metabolites (M4, M9, M10) in the plasma. Plasma concentration-time data were measured by validated LC-MS/MS method. Plasma PK data were analyzed using a non-compartmental method of analysis.|Day 1: Predose, 0.5 up to 312 hours postdose|"The PK Analysis Set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least 1 PK parameter. Here “Number analyzed signifies participants who were evaluable for this outcome measure for lemborexant and its metabolites (M4, M9, and M10)."|||hrs||Full Range|Median
2529620|NCT03440424|Secondary|AUC(0-inf): Area Under Plasma Concentration Versus Time Curve From Time Zero to Inf Hours Postdose of Lemborexant's Metabolites M4, M9, and M10|Blood samples were analyzed for the amount of lemborexant's metabolites (M4, M9, M10) in the plasma. Plasma concentration-time data were measured by validated LC-MS/MS method. AUC(0-inf) was calculated by the linear-up log-down trapezoidal method. Plasma PK data were analyzed using a non-compartmental method of analysis.|Day 1: Predose, 0.5 up to 312 hours postdose|"The PK Analysis Set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least 1 PK parameter. Here Number analyzed signifies participants who were evaluable for this outcome measure for different metabolites M4, M9, and M10."|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2529621|NCT03440424|Secondary|AUC(0-t Hours): Area Under Plasma Concentration Versus Time Curve From Time Zero to t Hours Postdose of Lemborexant's Metabolites M4, M9, and M10|Blood samples were analyzed for the amount of lemborexant's metabolites (M4, M9, M10) in the plasma. Plasma concentration-time data were measured by validated LC-MS/MS method. AUC(0-t hours) was calculated by the linear-up log-down trapezoidal method. Plasma PK data were analyzed using a non-compartmental method of analysis.|Day 1: Predose, 0.5 up to 312 hours postdose|The PK Analysis Set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least 1 PK parameter.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2529671|NCT03437564|Secondary|Tmax: Time to Reach Cmax (Observed Value) of Unchanged Lu AA21004||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|Pharmacokinetic (PK) Analysis Set; PK analysis set included all treated participants who had no major protocol violations, completed the minimum element of the protocol, and had evaluable pharmacokinetic data.|||Hours||Full Range|Median
2529622|NCT03440424|Secondary|AUC(0-72 Hours): Area Under Plasma Concentration Versus Time Curve From Time Zero to 72 Hours Postdose of Lemborexant's Metabolites M4, M9, and M10|Blood samples were analyzed for the amount of lemborexant's metabolites (M4, M9, M10) in the plasma. Plasma concentration-time data were measured by validated LC-MS/MS method. AUC(0-72 hours) was calculated by the linear-up log-down trapezoidal method. Plasma PK data were analyzed using a non-compartmental method of analysis.|Day 1: Predose, 0.5 up to 312 hours postdose|The PK Analysis Set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least 1 PK parameter.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2529623|NCT03440424|Secondary|AUC(0-8 Hours): Area Under Plasma Concentration Versus Time Curve From Time Zero to 8 Hours Postdose of Lemborexant's Metabolites M4, M9, and M10|Blood samples were analyzed for the amount of lemborexant's metabolites (M4, M9, M10) in the plasma. Plasma concentration-time data were measured by validated LC-MS/MS method. AUC(0-8 hours) was calculated by the linear-up log-down trapezoidal method. Plasma PK data were analyzed using a non-compartmental method of analysis.|Day 1: Predose, 0.5 up to 312 hours postdose|The PK Analysis Set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least 1 PK parameter.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2529624|NCT03440424|Secondary|Tmax: Time to Reach Maximum Plasma Concentration of Lemborexant and Its Metabolites M4, M9, M10|Blood samples were analyzed for the amount of lemborexant and its metabolites (M4, M9, M10) in the plasma. Plasma concentration-time data were measured by validated LC-MS/MS method. Plasma PK data were analyzed using a non-compartmental method of analysis.|Day 1: Predose, 0.5 up to 312 hours postdose|The PK Analysis Set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least 1 PK parameter.|||hours||Full Range|Median
2529625|NCT03440424|Secondary|Cmax: Maximum Plasma Concentration of Lemborexant's Metabolites M4, M9, and M10|Blood samples were analyzed for the amount of lemborexant's metabolites (M4, M9, M10) in the plasma. Plasma concentration-time data were measured by validated LC-MS/MS method. Plasma PK data were analyzed using a non-compartmental method of analysis.|Day 1: Predose, 0.5 up to 312 hours postdose|The PK Analysis Set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least 1 PK parameter.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2529626|NCT03440424|Secondary|AUCu: AUC(0-inf) Values Adjusted by Unbound Fraction in Plasma of Lemborexant|AUCu was defined as the AUC(0-inf) adjusted by unbound fraction in plasma, and calculated by multiplying the value of AUC(0-inf) with plasma protein unbound fraction (fu). Blood samples were analyzed for the amount of lemborexant in the plasma. Plasma concentration-time data were measured by validated LC-MS/MS method. AUCu was calculated by the linear-up log-down trapezoidal method. Plasma PK data were analyzed using a non-compartmental method of analysis.|Day 1: Predose, 0.5 up to 312 hours postdose|"The PK Analysis Set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least 1 PK parameter. Here Overall number of participants analyzed signifies the participants who were evaluable for this outcome measure."|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2529627|NCT03440424|Primary|AUC(0-inf): Area Under Plasma Concentration Versus Time Curve From Time Zero to Infinity of Lemborexant|Blood samples were analyzed for the amount of lemborexant in the plasma. Plasma concentration-time data were measured by validated LC-MS/MS method. AUC(0-inf) was calculated by the linear-up log-down trapezoidal method. Plasma PK data were analyzed using a non-compartmental method of analysis.|Day 1: Predose, 0.5 up to 312 hours postdose|"The PK Analysis Set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least 1 PK parameter. Here Overall number of participants analyzed signifies the participants who were evaluable for this outcome measure."|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2529628|NCT03440424|Primary|AUC(0-t Hours): Area Under Plasma Concentration Versus Time Curve From Time Zero to Time of Last Quantifiable Concentration of Lemborexant|Blood samples were analyzed for the amount of lemborexant in the plasma. Plasma concentration-time data were measured by validated LC-MS/MS method. AUC(0-t hours) was calculated by the linear-up log-down trapezoidal method. Plasma PK data were analyzed using a non-compartmental method of analysis.|Day 1: Predose, 0.5 up to 312 hours postdose|The PK Analysis Set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least 1 PK parameter.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2529629|NCT03440424|Primary|AUC(0-72 Hours): Area Under the Plasma Concentration-Time Curve From Time Zero to 72 Hours Postdose of Lemoborexant|Blood samples were analyzed for the amount of lemborexant in the plasma. Plasma concentration-time data were measured by validated LC-MS/MS method. AUC(0-72 hours) was calculated by the linear-up log-down trapezoidal method. Plasma PK data were analyzed using a non-compartmental method of analysis.|Day 1: Predose, 0.5 up to 312 hours postdose|The PK Analysis Set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least 1 PK parameter.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2529630|NCT03440424|Primary|AUC(0-8 Hours): Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours Postdose of Lemoborexant|Blood samples were analyzed for the amount of lemborexant in the plasma. Plasma concentration-time data were measured by validated LC-MS/MS method. AUC(0-8 hours) was calculated by the linear-up log-down trapezoidal method. Plasma PK data were analyzed using a non-compartmental method of analysis.|Day 1: Predose, 0.5 up to 312 hours postdose|The PK Analysis Set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least 1 PK parameter.|||hour nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2529631|NCT03440424|Primary|Cmax: Maximum Plasma Concentration of Lemborexant|Blood samples were analyzed for the amount of lemborexant in the plasma. Plasma concentration-time data were measured by validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. Plasma pharmacokinetic (PK) data were analyzed using a non-compartmental method of analysis.|Day 1: Predose, 0.5 up to 312 hours postdose|The PK Analysis Set was the group of participants who were dosed with the test drug and had sufficient PK data to derive at least 1 PK parameter.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2529632|NCT03439072|Secondary|Glucagon Preparation and Administration Time|"Time required to prepare and inject glucagon as measured between a decision to dose and completion of the injection"|0 to 5 minutes pre-dose|Intent to treat analysis population|||seconds||Standard Deviation|Mean
2529635|NCT03439072|Secondary|Glucose AUC|Area under the curve for plasma glucose.|0 to 180 minutes post dose - Blood samples for assessment of blood glucose concentration were collected every 5 minutes post-dose to 90 minutes, and then at 120, 150 and 180 minutes post dose.|Intent to treat analysis population. Due to missing data AUC was only evaluable in 67 subjects per arm.|||mg∙min/dL||Standard Deviation|Mean
2529636|NCT03439072|Secondary|Time to Resolution of the Feeling of Hypoglycemia|"Time from administration of glucagon to resolution of the overall sensation of hypoglycemia. Subjects were asked to answer yes/no to the question, Do you feel hypoglycemic? The time point as which the subject first answered no was considered the time of resolution."|0 to 180 minutes post dose|Intent to treat analysis population|||minutes||Standard Deviation|Mean
2529637|NCT03439072|Secondary|Time to Resolution of Neuroglycopenic Symptoms|Time from administration of glucagon to complete resolution of 4 neuroglycopenic symptoms of hypoglycemia. Four symptoms were assessed: dizziness, blurred vision, difficulty in thinking and faintness.|0 to 180 minutes post dose|Intent to treat analysis population|||minutes||Standard Deviation|Mean
2529638|NCT03439072|Secondary|Time to Resolution of Autonomic Symptoms|Time from administration of glucagon to complete resolution of 4 autonomic symptoms of hypoglycemia. Symptoms included: sweating, tremor, palpitations and feeling of nervousness.|0 to 180 minutes post dose|Intent to treat analysis population|||minutes||Standard Deviation|Mean
2529639|NCT03439072|Secondary|Number of Subjects With Relief of Neuroglycopenic Symptoms|Clearance of all neuroglycopenic symptoms of hypoglycemia within 30 minutes after receiving glucagon. Four symptoms were assessed: dizziness, blurred vision, difficulty in thinking and faintness.|0 to 30 minutes post dose|Intent to treat analysis population|||Participants|||Count of Participants
2529640|NCT03439072|Secondary|Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Relief of Neuroglycopenic Symptoms|A positive response for this endpoint is a return of plasma glucose to > 70 mg/dL or clearance of all neuroglycopenic symptoms of hypoglycemia within 30 minutes after receiving glucagon. Four symptoms were assessed: dizziness, blurred vision, difficulty in thinking and faintness.|0 to 30 minutes post dose|Intent to treat analysis population|||Participants|||Count of Participants
2529641|NCT03439072|Secondary|Time for Positive Glucose Increase|Time from administration of glucagon for plasma glucose to increase by ≥20 mg/dL from baseline|0 to 180 minutes post dose|Intent to treat analysis population|||minutes||Standard Deviation|Mean
2529642|NCT03439072|Secondary|Number of Subjects With a Positive Glucose Increase|Increase in plasma glucose by ≥ 20.0 mg/dL within 30 minutes after receiving glucagon|0 to 30 minutes post dose|Intent to treat analysis population|||Participants|||Count of Participants
2529643|NCT03439072|Secondary|Number of Subjects With a Positive Response for the Combination Endpoint: Positive Glucose Response/Positive Glucose Increase|A positive response for this endpoint is a return of plasma glucose to > 70 mg/dL or an increase in plasma glucose by ≥20 mg/dL within 30 minutes after receiving glucagon|0 to 30 minutes post dose|Intent to treat analysis population|||Participants|||Count of Participants
2529644|NCT03439072|Secondary|Time for Positive Glucose Response|Time from administration of glucagon for plasma glucose to rise from below 50.0 mg/dL to above 70.0 mg/dL|0 to 180 minutes post dose|Intent-to treat analysis population|||minutes||Standard Deviation|Mean
2529645|NCT03439072|Primary|Number of Subjects With a Positive Glucose Response|Increase in plasma glucose concentration from below 50.0 mg/dL to greater than 70.0 mg/dL within 30 minutes after receiving glucagon|0 to 30 minutes post dose|Intent to treat analysis population|||Participants|||Count of Participants
2529646|NCT03438539|Secondary|Treatment Acceptability Questionnaire|Total average ratings on a treatment acceptability questionnaire, rated from 0 (minimum) to 100 (maximum). Higher scores indicate greater treatment acceptability.|2 weeks|These data include only participants that were randomized and completed the follow-up assessment providing valid acceptability data.|||units on a scale||Standard Deviation|Mean
2529647|NCT03438539|Secondary|Percentage of Sessions Completed (Feasibility)|Completion rates during intervention period|2 weeks||||percentage of sessions completed||Standard Deviation|Mean
2529648|NCT03438539|Primary|Alcohol Use|Self-report of percent of heavy alcohol drinking days|Past two weeks|These data include only participants that were randomized and completed the follow-up assessment providing valid alcohol use data.|||percentage heavy drinking days||Standard Deviation|Mean
2529649|NCT03438383|Secondary|Days of Hospitalization|duration of hospitalization, calculated by discharge date minus admission date|From day of admission to day of discharge from the hospital|Overall number of patients analyzed in each group is the sum of participants who underwent gastroplasty and those who underwent open gastric bypass (11+3=14 for the Sham Bi-PAP group and 15+6=21 for the Bi-PAP group).|||days||Full Range|Mean
2529650|NCT03438383|Secondary|Post-operative Pain|Intensity of pain was assessed post-operatively by Numerical Rating Scale (NRS) (0-10, 0=no pain, 10=worst pain imaginable)|right before spirometry, at 24, 48 and 72 h post-operatively||||score on a scale||Standard Deviation|Mean
2529651|NCT03438383|Primary|Number of Participants With Atelectasis|occurrence of atelectasis as defined by chest X-ray (CXR) post-operatively with CXR before surgery as baseline|At 24, 48 and 72 hours post-operatively||||Participants|||Count of Participants
2529652|NCT03438383|Primary|Number of Participants With Hypoxemia|occurrence of hypoxemia, considered as SpO2<90%, post-operatively|At 24, 48 and 72 hours post-operatively||||Participants|||Count of Participants
2529653|NCT03438383|Primary|SpO2 Difference|difference in SpO2 value measured by spirometry pre- and post-operatively|24 h before surgery and at 24, 48 and 72 hours post-operatively||||percentage of SpO2||Standard Deviation|Mean
2529654|NCT03438383|Primary|Peak Expiratory Flow Rate (PEFR) Difference|difference in PEFR value measured by spirometry pre- and post-operatively|24 h before surgery and at 24, 48 and 72 hours post-operatively||||Litres/minute||Standard Deviation|Mean
2529655|NCT03438383|Primary|Forced Vital Capacity (FVC) Difference|difference in FVC value measured by spirometry pre- and post-operatively|24 h before surgery and at 24, 48 and 72 hours post-operatively||||Litres||Standard Deviation|Mean
2529656|NCT03438383|Primary|Forced Expiratory Volume at One Second (FEV1) Difference|difference in FEV1 value measured by spirometry pre- and post-operatively|24 h before surgery and at 24, 48 and 72 h post-operatively||||Litres||Standard Deviation|Mean
2553724|NCT02770625|Primary|The Difference in Hemoglobin Concentration [g/dL]||from baseline to Week 24||||g/dL||Standard Deviation|Mean
2529657|NCT03438266|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE that initially occurred or increased in severity on or after the treatment start date.|Up to 3 months|Safety population included all randomized participants who received at least 1 study treatment. The data for adverse events is reported by participant because both treatments were received at the same time and it included both treatment-related and non-treatment-related adverse events.|||Participants|||Count of Participants
2529658|NCT03438266|Secondary|Change From Baseline in FACE-Q Satisfaction With Cheeks Questionnaire Score|The participant completed the 5-item Satisfaction with Cheeks module of the FACE-Q questionnaire that evaluated various aspects of the cheeks including symmetry, smoothness, attractiveness, contour, and fullness using a 4-point scale where: 1=very dissatisfied to 4=very satisfied. The total score was transformed to a 0 to 100 point scale, with higher scores indicating greater satisfaction. A positive change from Baseline indicates improvement. The FACE-Q Satisfaction with Cheeks outcome was assessed by the participant overall and not by each cheek.|Baseline (Screening) to Month 1|mITT population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek. FACE-Q is a global assessment and was administered per participant.|||score on a scale||Standard Deviation|Mean
2529659|NCT03438266|Secondary|Percentage of Participants With at Least a 1-Point Improvement (Decrease From Baseline) in MFVDS Score|The EI assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) [best] to 5=Severe (wasting) [worst]. The percentage of participants who showed ≥1-point improvement (decrease in severity) from Baseline is reported.|Baseline (Screening) to Month 1|mITT population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek.|||percentage of participants||95% Confidence Interval|Number
2529660|NCT03438266|Primary|Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score|The evaluating investigator (EI) assessed the participant's overall mid-face volume deficit for each cheek using a 6-point photonumeric scale, where: 0=None (moon face; fullness) [best] to 5=Severe (wasting) [worst]. A negative change from Baseline indicates improvement.|Baseline (Screening) to Month 1|mITT population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek.|||score on a scale||Standard Deviation|Mean
2529661|NCT03437733|Primary|Percentage of Participants With Acute Procedural Success|Acute procedural success is defined as confirmation of entrance block in treated pulmonary veins (PV) after adenosine and/or isoproterenol challenge (with or without the use of a focal catheter).|Day 1|PP analysis set included participants who comply with the following criteria: a). were enrolled and met all eligibility criteria; b). had undergone RF ablation with study catheters; c) were treated for the study-related arrhythmia. Population included participants who had the adenosine/isoproterenol challenge.|||Percentage of participants|||Number
2529662|NCT03437733|Primary|Number of Participants With Early Onset Primary Adverse Events (PAEs)|PAEs included death, stroke/cerebrovascular accident or stroke (CVA), atrio-esophageal fistula, transient ischemic attack (TIA), myocardial infarction, phrenic nerve paralysis, cardiac tamponade/perforation, pulmonary vein stenosis, thromboembolism, major vascular access complication/bleeding.|Up to 7 days (post initial mapping and ablation procedure)|The population analysis included the modified intent-to-treat (mITT) analysis set included all enrolled participants who met eligibility criteria, had undergone insertion of the study catheters and were followed-up for 90-days period for evaluation of PAEs.|||Participants|||Count of Participants
2529663|NCT03437564|Secondary|Number of Participants With TEAE Related to 12-lead Electrocardiograms||Up to Day 25|Safety Analysis Set; The safety analysis set included all participants who received at least one dose of the study drug.|||Participants|||Count of Participants
2529664|NCT03437564|Secondary|Number of Participants With TEAE Related to Clinical Laboratory Tests (Alanine Aminotransferase Increased)||Up to Day 25|Safety Analysis Set; The safety analysis set included all participants who received at least one dose of the study drug.|||Participants|||Count of Participants
2529665|NCT03437564|Secondary|Number of Participants With TEAE Related to Vital Sign||Up to Day 25|Safety Analysis Set; The safety analysis set included all participants who received at least one dose of the study drug.|||Participants|||Count of Participants
2529666|NCT03437564|Secondary|Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)||Up to Day 25|Safety Analysis Set; The safety analysis set included all participants who received at least one dose of the study drug.|||Participants|||Count of Participants
2529667|NCT03437564|Secondary|T1/2z: Apparent Elimination Half-Life of Unchanged Lu AA21004||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|Pharmacokinetic (PK) Analysis Set; PK analysis set included all treated participants who had no major protocol violations, completed the minimum element of the protocol, and had evaluable pharmacokinetic data.|||Hours||Standard Deviation|Mean
2529668|NCT03437564|Secondary|λz: Apparent Elimination Rate Constant of Unchanged Lu AA21004||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|Pharmacokinetic (PK) Analysis Set; PK analysis set included all treated participants who had no major protocol violations, completed the minimum element of the protocol, and had evaluable pharmacokinetic data.|||1/Hours||Standard Deviation|Mean
2529669|NCT03437564|Secondary|MRTlast, ev: Mean Residence Time From Time 0 to the Time of the Last Quantifiable Concentration of Unchanged Lu AA21004||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|Pharmacokinetic (PK) Analysis Set; PK analysis set included all treated participants who had no major protocol violations, completed the minimum element of the protocol, and had evaluable pharmacokinetic data.|||Hours||Standard Deviation|Mean
2529670|NCT03437564|Secondary|MRT∞, ev: Mean Residence Time 0 to Infinity of Unchanged Lu AA21004||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|Pharmacokinetic (PK) Analysis Set; PK analysis set included all treated participants who had no major protocol violations, completed the minimum element of the protocol, and had evaluable pharmacokinetic data.|||Hours||Standard Deviation|Mean
2529672|NCT03437564|Secondary|AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Unchanged Lu AA21004||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|Pharmacokinetic (PK) Analysis Set; PK analysis set included all treated participants who had no major protocol violations, completed the minimum element of the protocol, and had evaluable pharmacokinetic data.|||h*ng/mL||Standard Deviation|Mean
2529673|NCT03437564|Primary|Cmax: Maximum Plasma Concentration (Observed Value) of Unchanged Lu AA21004||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|Pharmacokinetic (PK) Analysis Set; PK analysis set included all treated participants who had no major protocol violations, completed the minimum element of the protocol, and had evaluable pharmacokinetic data.|||ng/mL||Standard Deviation|Mean
2529674|NCT03437564|Primary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Time Point of Unchanged Lu AA21004||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|Pharmacokinetic (PK) Analysis Set; PK analysis set included all treated participants who had no major protocol violations, completed the minimum element of the protocol, and had evaluable pharmacokinetic data.|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
2529675|NCT03437447|Secondary|Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG) Findings|Number of participants with clinically significant abnormalities in 12-lead electrocardiogram (ECG) were reported. The 12-lead ECGs were recorded after the participants have rested for at least 5 minutes in supine position.|Baseline up to Day 29|Safety Analysis Set included all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2529676|NCT03437447|Secondary|Number of Participants With Clinically Significant Abnormalities in Vital Signs|Number of participants with clinically significant abnormalities in vital signs were reported. Vital signs included body temperature, systolic / diastolic blood pressure, and pulse rate.|Baseline up to Day 29|Safety Analysis Set included all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2529677|NCT03437447|Secondary|Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters|Number of participants with clinically significant abnormalities in laboratory parameters were reported. Laboratory investigation included hematology, biochemistry, urinalysis and coagulation.|Baseline up to Day 29|Safety Analysis Set included all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2529678|NCT03437447|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs.|Baseline up to Day 29|Safety Analysis Set included all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2529679|NCT03437447|Secondary|Maximum Observed Plasma Concentration (Cmax) of Racemate PZQ (Rac-PZQ)|The maximum observed plasma concentration of rac-Praziquantel (rac-PZQ).|Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose|PK analysis set included all participant who received all administrations of treatment and have PK parameters for AUC0-t and Cmax in all periods and without any relevant protocol violations and factors likely to affect the comparability of PK results.|||ng/mL||Standard Deviation|Mean
2529680|NCT03437447|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Racemate PZQ (Rac-PZQ)|Area under the drug plasma concentration-time curve from time zero to the time last measurable concentration.|Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose|PK analysis set included all participant who received all administrations of treatment and have PK parameters for AUC0-t and Cmax in all periods and without any relevant protocol violations and factors likely to affect the comparability of PK results.|||h*ng/ml||Standard Deviation|Mean
2529681|NCT03437447|Secondary|Apparent Volume of Distribution During Terminal Phase (Vd/f) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vd/f after oral dose was influenced by the fraction absorbed.|Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose|"PK analysis set: All participants who received all administrations of treatment & have PK parameters for AUC0-t & Cmax in all periods without any relevant protocol violations & factors likely to affect comparability of PK results. Here Number analyzed signifies those participants who were evaluable for this outcome measure for specified category."|||Milliliter||Standard Deviation|Mean
2529682|NCT03437447|Secondary|Apparent Clearance (CL/f) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose|"PK analysis set: All participants who received all administrations of treatment & have PK parameters for AUC0-t & Cmax in all periods without any relevant protocol violations & factors likely to affect comparability of PK results. Here Number analyzed signifies those participants who were evaluable for this outcome measure for specified category."|||Milliliter per hour||Standard Deviation|Mean
2529709|NCT03434977|Primary|CL/F: Apparent Clearance for TAK-536||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.|||Liter per hour (L/h)||Standard Deviation|Mean
2529916|NCT03418064|Primary|Lens Centration|Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)|1 Month||||Participants|||Count of Participants
2529683|NCT03437447|Secondary|Terminal Elimination Rate Constant (Lambda Z) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ)|Lambda Z was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.|Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose|PK analysis set included all participants who received all administrations of treatment and have PK parameters for AUC0-t and Cmax in all periods and without any relevant protocol violations and factors likely to affect the comparability of PK results.|||Per hour||Full Range|Median
2529684|NCT03437447|Secondary|Terminal Elimination Half-Life (t1/2) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ)|Elimination Half Life (t1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half.|Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose|"PK analysis set: All participants who received all administrations of treatment & have PK parameters for AUC0-t & Cmax in all periods without any relevant protocol violations & factors likely to affect comparability of PK results. Here Number analyzed signifies those participants who were evaluable for this outcome measure for specified category."|||hours||Standard Deviation|Mean
2529685|NCT03437447|Secondary|Extrapolated Area Under the Plasma Concentration Curve From Time Tlast to Infinity (AUCextra) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ)|AUCextra was reported in terms of percentage of AUC0-inf.|Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose|"PK analysis set: All participants who received all administrations of treatment & have PK parameters for AUC0-t & Cmax in all periods without any relevant protocol violations & factors likely to affect comparability of PK results. Here Number analyzed signifies those participants who were evaluable for this outcome measure for specified category."|||Percentage of AUC0-inf||Standard Deviation|Mean
2529686|NCT03437447|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ)|AUC0-inf is defined as the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).|Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose|"PK analysis set: All participants who received all administrations of treatment & have PK parameters for AUC0-t & Cmax in all periods without any relevant protocol violations & factors likely to affect comparability of PK results. Here Number analyzed signifies those participants who were evaluable for this outcome measure for specified category."|||h*ng/ml||Standard Deviation|Mean
2529687|NCT03437447|Secondary|Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ)|Time prior to the first measurable (non-zero) concentration; calculated as last time point at which the concentration is less than (<) Lower Limit of Quantification (LLOQ) before the occurrence of the first quantifiable concentration.|Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose|PK analysis set included all participant who received all administrations of treatment and have PK parameters for AUC0-t and Cmax in all periods and without any relevant protocol violations and factors likely to affect the comparability of PK results.|||hours||Full Range|Median
2529688|NCT03437447|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of L-Praziquantel (L-PZQ) and Racemate PZQ (Rac-PZQ)|Time of the maximum drug concentration.|Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose|PK analysis set included all participant who received all administrations of treatment and have PK parameters for AUC0-t and Cmax in all periods and without any relevant protocol violations and factors likely to affect the comparability of PK results.|||hours||Full Range|Median
2529689|NCT03437447|Primary|Maximum Observed Plasma Concentration (Cmax) of L-Praziquantel (L-PZQ)|The maximum observed plasma concentration of L-Praziquantel (L-PZQ).|Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose|PK analysis set included all participant who received all administrations of treatment and have PK parameters for AUC0-t and Cmax in all periods and without any relevant protocol violations and factors likely to affect the comparability of PK results.|||ng/mL||Standard Deviation|Mean
2529690|NCT03437447|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of L-Praziquantel (L-PZQ)|Area under the plasma concentration-time curve from 0 to the time of the last quantifiable concentration.|Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 8.0, 9.0, 10.0 and 12.0 hours post-dose|Pharmacokinetic (PK) analysis set included all participants who received all administrations of treatment and have PK parameters for AUC0-t and maximum observed plasma concentration (Cmax) in all periods and without any relevant protocol violations and factors likely to affect the comparability of PK results.|||Hour*nanogram per milliliter (h*ng/ml)||Standard Deviation|Mean
2529691|NCT03436732|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately one month and 25 days for the 100 mcg/kg Arm/Group, and 9 months and 28 days for the 140 mcg/kg Arm/Group.||||Participants|||Count of Participants
2529692|NCT03436732|Secondary|Fraction of Participants With Detectable LMB-100 in Blood After Cycle 4|Blood is measured for a detectable level of LMB-100 in the blood. LMB-100 is either detectable in the blood or not. A detectable level of LMB-100 in the blood is considered a desirable outcome for the participant. Hence, the reverse is not a considered a desirable outcome for the participant.|Day 85|This outcome measure was not done because the study was closed due to a fatal occurrence of pneumonitis that was attributed to one of the study drugs.||||||
2529917|NCT03418064|Primary|Lens Centration|Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)|Dispense||||Participants|||Count of Participants
2529693|NCT03436732|Secondary|Number of Participants With Partial Response or Complete Response (PR + CR)|Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesion, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|42 days||||Participants|||Count of Participants
2529694|NCT03436732|Primary|Maximum Tolerated Dose (MTD)|MTD is defined as the highest tested dose of LMB-100 and SEL-110 at which no more than 1 of 6 subjects experience a dose limiting toxicity. A dose limiting toxicity is defined as any of the following: Grade 4 neutropenia for a minimum duration of 7 days. Grade 4 thrombocytopenia (≤25.0 x 10(9) cells/L), Grade 3 thrombocytopenia associated with bleeding episodes, and Grade 4 anemia. Grade ≥3 non-hematological toxicity with the exception of Alopecia (any grade), Grade 3 nausea and vomiting lasting > 48 hours despite appropriate treatment, Grade 3 diarrhea lasting for ≤ 2 days with no fever or dehydration, and laboratory values of ≥ grade 3 that are judged not clinically significant by the investigator. Any other drug related toxicity considered significant enough to be qualified as a DLT in the opinion of the principal investigator. Inability to start cycle 2 within 3 weeks after completing cycle 1 due to drug-related adverse events.|Day 21|MTD was not found because the study was closed due to a fatal occurrence of pneumonitis that was attributed to one of the study drugs.||||||
2529695|NCT03436732|Primary|Number of Participants With Grade ≥3 Adverse Events Related to Study Drug at Dose Level 140 mcg/kg and 100 mcg/kg|Here are the grade ≥3 adverse events at each dose level assessed by the Common Terminology Criteria in Adverse Events CTCAE v5.0. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 3 is Severe or medically significant but not immediately life-threatening;hospitalization or prolongation of hospitalization indicated; disabling;limiting self care ADL (i.e., bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. Grade 4 is life-threatening consequences;urgent intervention indicated. Grade 5 is death related to adverse event.|Day 85||||Participants|||Count of Participants
2529696|NCT03435783|Primary|Average Number of Drinks Per Drinking Day|Assessed using Timeline Follow Back (TLFB)|Past 30 days||||Drinks||Standard Deviation|Mean
2529697|NCT03435783|Primary|Number of Heavy Drinking Days (5 or More), Past 30 Days|Assessed via self-report using Timeline Follow Back (TLFB); count of the number of days.|Past 30 days||||Days||Standard Deviation|Mean
2529698|NCT03435783|Primary|Number of Drinking Days, Past 30 Days|Assessed via self-report using Timeline Follow Back (TLFB); count of the average number of drinking days in the past 30|Past 30 days||||Days||Standard Deviation|Mean
2529699|NCT03435783|Primary|Number of Condomless Anal Sex Events, Past 30 Days|Assessed via self-report using Timeline Follow Back (TLFB); count of the number of such events.|Past 30 days||||Events||Standard Deviation|Mean
2529700|NCT03435783|Primary|Number of New Sex Partners, Past 30 Days|Assessed via self-report using Timeline Follow Back (TLFB)|Past 30 days||||New partners||Standard Deviation|Mean
2529701|NCT03435185|Primary|Change of Severity of Headache|Mean visual analog scale (VAS) scores. Scores from both months were avareged. Minimum=0 Maximum=10. Lower scores mean a better outcome|Patients were followed up for 2 months from baseline after first injection.||||score on a scale||Standard Deviation|Mean
2529702|NCT03435185|Primary|Change of Frequency of Headache|Number of headache days in a month. Scores from both months were averaged. Minimum=0 Maximum=30. Lower scores mean a better outcome.|Patients were followed up from baseline to 2 months after first injection.||||score on a scale||Standard Deviation|Mean
2529703|NCT03434977|Secondary|Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECGs)||Baseline up to Day 18 (End of Period 2)|The safety analysis set was defined as all participants who received at least one dose of the study drug. Out of 12 participants, only 11 participants received study drug under fasted condition, since 1 participant discontinued the study due to AE before the start of Period 2.|||Participants|||Count of Participants
2529704|NCT03434977|Secondary|Number of Participants With TEAE Related to Clinical Laboratory Tests (Eosinophil Count Increased)||Baseline up to Day 18 (End of Period 2)|The safety analysis set was defined as all participants who received at least one dose of the study drug. Out of 12 participants, only 11 participants received study drug under fasted condition, since 1 participant discontinued the study due to AE before the start of Period 2.|||Participants|||Count of Participants
2529705|NCT03434977|Secondary|Number of Participants With TEAE Related to Body Weight||Baseline up to Day 18 (End of Period 2)|The safety analysis set was defined as all participants who received at least one dose of the study drug. Out of 12 participants, only 11 participants received study drug under fasted condition, since 1 participant discontinued the study due to AE before the start of Period 2.|||Participants|||Count of Participants
2529706|NCT03434977|Secondary|Number of Participants With TEAE Related to Vital Sign||Baseline up to Day 18 (End of Period 2)|The safety analysis set was defined as all participants who received at least one dose of the study drug. Out of 12 participants, only 11 participants received study drug under fasted condition, since 1 participant discontinued the study due to AE before the start of Period 2.|||Participants|||Count of Participants
2529707|NCT03434977|Secondary|Number of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)||Baseline up to Day 18 (End of Period 2)|The safety analysis set was defined as all participants who received at least one dose of the study drug. Out of 12 participants, only 11 participants received study drug under fasted condition, since 1 participant discontinued the study due to adverse event (AE) before the start of Period 2.|||Participants|||Count of Participants
2529708|NCT03434977|Primary|Vz/F: Apparent Volume of Distribution for TAK-536||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.|||liter||Standard Deviation|Mean
2529710|NCT03434977|Primary|λz: Terminal Disposition Phase Rate Constant for TAK-536||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.|||1 per hour (1/h)||Standard Deviation|Mean
2529711|NCT03434977|Primary|MRT∞, ev: Mean Residence Time From Time 0 to Infinity for TAK-536||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.|||hours||Standard Deviation|Mean
2529712|NCT03434977|Primary|MRTlast, ev: Mean Residence Time From Time 0 to the Time of the Last Quantifiable Concentration for TAK-536||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.|||hours||Standard Deviation|Mean
2529713|NCT03434977|Primary|T1/2z: Terminal Disposition Phase Half-life for TAK-536||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.|||hours||Standard Deviation|Mean
2529714|NCT03434977|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.|||h*ng/mL||Standard Deviation|Mean
2529715|NCT03434977|Primary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-536||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
2529716|NCT03434977|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set was defined as all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.|||hours||Full Range|Median
2529717|NCT03434977|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-536||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The pharmacokinetic (PK) analysis set was defined as all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2529718|NCT03434249|Secondary|Secretory Immunoglobulin A (SIgA)|Secretory immunoglobulin A (SIgA) levels in fecal samples|at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)|The analysis Population includes all the participants for wich an evaluable fecal sample was available at Visit T1 and Visit T5|||microg/g||Standard Deviation|Mean
2529719|NCT03434249|Secondary|Short Chain Fatty Acids - Butyrate|Evaluation of Butyrate levels in fecal samples|at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)|The analysis Population includes all participants for wich an evaluable fecal sample was available at Visit T1 and Visit T5|||mM/Kg||Standard Deviation|Mean
2529720|NCT03434249|Secondary|LL37 Peptide|Evaluation of LL37 peptide levels in fecal samples|at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)|The analysis Population includes all participants for wich an evaluable fecal sample was available at Visit T1 and Visit T5|||ng/g||Standard Deviation|Mean
2529721|NCT03434249|Secondary|Beta-defensin Type 2|Evaluation of Beta-defensin type 2 levels in fecal samples|at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)|The analysis Population includes all participants for wich an evaluable fecal sample was available at Visit T1 and Visit T5|||ng/g||Standard Deviation|Mean
2529722|NCT03434249|Secondary|Calprotectin|Evaluation of calprotectin levels in fecal samples|at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)|The analysis Population includes all participants for wich an evaluable fecal sample was available at Visit T1 and Visit T5|||mM/Kg||Standard Deviation|Mean
2529723|NCT03434249|Secondary|Infant's Feeding|Duration of feeding (in minutes) was collected daily in the diary during the entire study period. Mean daily feeding time by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data.|at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)|Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment.|||minutes||Standard Deviation|Mean
2529724|NCT03434249|Secondary|Infant's Temper|Duration of temper episodes (in minutes) was collected daily in the diary during the entire study period. Mean daily duration of temper episodes by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data.|at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)|Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment.|||minutes||Standard Deviation|Mean
2529725|NCT03434249|Secondary|Infant's Sleep|Duration of sleep (in minutes) was collected daily in the diary during the entire study period. Mean daily duration of sleep by week was defined as the mean of the daily durations during the selected week and was described by means of descriptive statistics for continuous data.|at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)|Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment. The number of participants analyzed in Visit T5 is less then Visit T1 since 8 participants dropped from the study before Visit T5|||minutes||Standard Deviation|Mean
2529736|NCT03434119|Secondary|Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 26|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized breakfast meal.|Baseline, Week 26|Data were not collected, hence planned analysis was not performed due to early termination of the study.||||||
2529918|NCT03418064|Primary|Lens Centration|Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable)|Baseline||||Participants|||Count of Participants
2529726|NCT03434249|Secondary|Infant's Mood|"The infant's mood (calm, asleep, agitated, irritable) was collected daily in the diary and was evaluated as the number and the proportion of infants who reported at least one mood of each type per week.~Patients could report more than one mood per day then the sum of the Count of Participants for each group at each visit could be greater then the Overall Number of Participants Analyzed."|at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)|Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment. The number of participants analyzed in Visit T5 is less then Visit T1 since 8 participants dropped from the study before Visit T5|||participants|||Number
2529727|NCT03434249|Secondary|Bowel Evacuation - Stool Consistency|"Stool consistency was evaluated as the number and the proportion of patients who reported at least one stool sample of each type per week, according to Bristol scale as follows:~Type A = separate hard lumps, like nuts (hard to pass) Type B = sausage-shaped, but lumpy Type C = Like a sausage but with cracks on its surface Type D = like a sausage or snake, smooth and soft Only a descriptive statistics Type E = soft blobs with clear-cut edges (passed easily) Type F = fluffy pieces with ragged edges, a mushy stool Type G = watery, no solid pieces (entirely liquid). Patients could report more than one stool consistency per day then the sum of the Count of Participants for each group at each visit could be Greater then the Overall Number of Participants Analyzed"|at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)|"Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment.~The number of participants analyzed in Visit T5 is less then Visit T1 since 8 participants dropped from the study before Visit T5."|||participants|||Number
2529728|NCT03434249|Secondary|Bowel Evacuation - Stool Frequency|Daily frequency of bowel evacuation. The frequency of stools were collected daily in the diary. Stool frequency was evaluated as the mean of total daily stools reported per week.|at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)|"Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment.~The number of participants analyzed in Visit T5 is less then Visit T1 since 8 participants dropped from the study before Visit T5"|||daily number of bowel evacuations||Standard Deviation|Mean
2529729|NCT03434249|Secondary|Infectious Diseases Incidence|"Number of infections in respiratory system, gastrointestinal system, urinary tract and skin.~An infection was defined as an Adverse Event with SOC equal to Infections and Infestations."|at each visit, for 5 weeks starting from the enrollment in the study (Visit T0, T1, T2, T3, T4 and T5)|Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment.|||Number of infections||Standard Deviation|Mean
2529730|NCT03434249|Secondary|Number of Crying Episodes|"Weekly mean of cries will be defined as the mean number of cries reported in the Evaluation of behavior section during the week (i.e. number of episodes/number of days with episodes) and will be described by means of descriptive statistics for continuous data.~Mean changes from baseline (i.e. mean of the first Week) to the mean of the selected week will be analyzed too."|at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)|"Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment.~The number of participants analyzed in Visit T5 is less then Visit T1 since 8 participants dropped from the study before Visit T5"|||number of episodes||Standard Deviation|Mean
2529731|NCT03434249|Primary|Number of Participants With >=50% Reduction in Mean Weekly Crying Duration|"Treatment success rate was evaluated in terms of reduction of crying duration, comparing mean weekly duration of the last Week (from T4 to T5) and mean weekly duration of Week 1 (from T0 to T1). The daily number and duration of crying episodes has been collected in the 'Evaluation of crying' section of the patient diary.~Weekly mean is defined as the mean of the calculated average daily durations during the selected week and is described by means of descriptive statistics for continuous data. Mean changes from baseline (i.e. mean of the first Week) to the mean of the selected week will be computed as well.~The following categories of patients has been defined:~Success = patients who meet the criteria for the treatment success rate No Success = patients who do not meet the criteria for the treatment success rate Missing = patients who did not do the last visit (Visit T5 - at 28 days from baseline)"|at 28 days from the baseline (Visit T5)|"Intention to Treat Set (ITT): all randomized patients who received at least one dose of study treatment. Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they were assigned to at the randomization visit.~Patients drop-out were also considered and classified as Treatment success rate = Missing."|||Participants|||Count of Participants
2529732|NCT03434119|Secondary|Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period|Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented hypoglycemia with plasma glucose cut-off of <=70 mg/dL (3.9 mmol/L) was any hypoglycemia documented by a measured plasma glucose <=70 mg/dL (3.9 mmol/L) and excluding plasma glucose <54 mg/dL regardless of symptoms. Documented hypoglycemia with plasma glucose cut-off of <54 mg/dL (3.0 mmol/L) was any hypoglycemia documented by a measured plasma glucose <54 mg/dL (3.0 mmol/L) regardless of symptoms.|Baseline to Week 26|Analysis was performed on safety population that included all randomized participants who received at least 1 dose of open-label investigational medicinal product (IMP), regardless of the amount of treatment administered. Participants were analyzed according to the treatment actually received.|||percentage of participants|||Number
2529733|NCT03434119|Secondary|Change From Baseline in Body Weight at Week 26|Change in body weight was calculated by subtracting baseline value from Week 26 value.|Baseline, Week 26|Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||kilograms (kg)||Standard Deviation|Mean
2529734|NCT03434119|Secondary|Change From Baseline in Daily Insulin Glargine Dose at Week 26|Change in daily dose was calculated by subtracting baseline value from Week 26 value.|Baseline, Week 26|Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||International Units (IU)||Standard Deviation|Mean
2529735|NCT03434119|Secondary|Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test at Week 26||Baseline, Week 26|Data were not collected, hence planned analysis was not performed due to early termination of the study.||||||
2530086|NCT03413618|Secondary|Clinically Relevant Non-major Bleeding|any non-major bleeding requiring anticoagulant withdrawal, and/or performing haemostatic measures, and/or hospitalization, and/or an unscheduled medical appointment|12 months||||Participants|||Count of Participants
2529737|NCT03434119|Secondary|Percentage of Participants Achieving HbA1c Target of <7% at Week 26|Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.|Week 26|Analysis was performed on ITT population. Here, overall number of participants analyzed = participants with available data for the specified outcome measure.|||percentage of participants|||Number
2529738|NCT03434119|Primary|Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26|Change in HbA1c was calculated by subtracting baseline value from Week 26 value.|Baseline, Week 26|Analysis was performed on intent-to-treat (ITT) population that included all randomized participants. Here, overall number of participants analyzed = participants with available data for the specified outcome measure.|||percentage of HbA1c||Standard Deviation|Mean
2529739|NCT03433703|Secondary|Time to Progression (TTP)|TTP based on mRECIST (and including the RECIST 1.1 conventions for non-hepatic lesions) is defined as the time from the date of the first dose of first-line lenvatinib treatment to the date of the first documentation of disease progression during subsequent systemic TPC. PD is defined at least 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. TTP was to be calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval.|From first dose date until PD (approximately 3 months)|The safety analysis set (full analysis set) included all participants who received at least 1 dose of the lenvatinib treatment.|||months||95% Confidence Interval|Median
2529740|NCT03433703|Secondary|Progression-free Survival (PFS)|PFS based on modified Response Evaluation Criteria in Solid Tumors (mRECIST) (and including the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 conventions for non-hepatic lesions) is defined as the time from the date of the first dose of first-line lenvatinib treatment to the date of the first documentation of PD, or the date of death during the subsequent systemic TPC, whichever occurs first. PD is defined at least 20% increase (including an absolute increase of at least 5 millimeter [mm]) in the sum of diameters of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was to be calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval.|From first dose date until PD or date of death from any cause (approximately 3 months)|The safety analysis set (full analysis set) included all participants who received at least 1 dose of the lenvatinib treatment.|||months||95% Confidence Interval|Median
2529741|NCT03433703|Secondary|Overall Survival (OS)|OS is defined as the time from the date of first dose of study treatment to the date of death from any cause. Participants who are lost to follow-up are censored at the last date the participant was known to be alive, and participants who remain alive are censored at the time of data cutoff. OS was to be calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval.|From first dose date until date of death from any cause (approximately 3 months)|The safety analysis set (full analysis set) included all participants who received at least 1 dose of the lenvatinib treatment.|||months||95% Confidence Interval|Median
2529742|NCT03433703|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||From the first dose of study drug up to 28 days after the last dose of study drug (approximately 3 months)|The safety analysis set (full analysis set) included all participants who received at least 1 dose of the lenvatinib treatment.|||Participants|||Count of Participants
2529743|NCT03433677|Secondary|Number of Participants With Severe Hypoglycemic Events|Number of participants with severe hypoglycemic events. Severe hypoglycemia was defined as participants with an altered mental status and could not assist in their own care, may have been semiconscious or unconscious, or experienced coma with or without seizures, and the event required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Blood glucose measurements may not have been available during such an event, but neurological recovery attributable to the restoration of BG concentration to normal was considered sufficient evidence that the event was induced by a low BG concentration (BG ≤70 mg/dL [3.9 mmol/L]).|6 Weeks|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2529744|NCT03433677|Secondary|Interstitial Glucose Reduction Rate From Hyperglycemia Following a Non-Meal-Related Correction Bolus Delivered Via the Pump|Interstitial glucose reduction rate (glucose reduction [mg/dL] per minute) within 4 hours following a non-meal-related correction bolus via the pump, from hyperglycemia (interstitial glucose >180 mg/dL [10 mmol/L]) to recovery (interstitial glucose ≤180 mg/dL).|6 Weeks|All randomized participants who received at least 1 dose of study drug and non-missing baseline value and at least one non-missing post-baseline value of the response.|||mg/dL/min||Standard Error|Least Squares Mean
2529745|NCT03433677|Secondary|Ratio of Bolus/Total Insulin Dose|The bolus and total insulin doses for each visit was calculated as the mean of the doses for the last 3 days prior to the visit date that are entered in the eCRF. The bolus/total ratio was derived as the bolus dose divided by the total insulin dose at each visit.|6 Weeks|All randomized participants who received at least 1 dose of study drug and non-missing baseline value and at least one non-missing post-baseline value.|||percentage of total insulin dose||Standard Error|Least Squares Mean
2529746|NCT03433677|Secondary|Time Interval Until Infusion Set Change|Time interval until infusion set change reflects the time interval in hours until infusion set change from first to last dose. MMRM model for post-baseline measures: Variable = Baseline + Period + Sequence + Strata(Region + Historical Use of SmartGuard/Threshold Suspend + HbA1c(<=7.3%, >7.3%)) + Treatment (Type III sum of squares).|6 Weeks|All randomized participants who received at least 1 dose of study drug and non-missing baseline value and at least one non-missing post-baseline value.|||hours||Standard Error|Least Squares Mean
2529747|NCT03433677|Secondary|Rate of Premature Infusion Set Changes|Rate of premature infusion set changes.|6 Weeks|All randomized participants who received at least 1 dose of study drug.|||events per 30 participant days|||Number
2529748|NCT03433677|Secondary|Percentage of Participants With at Least 1 Event of Infusion Set Failure|Infusion set failures are defined as premature infusion set changes, due to a pump occlusion alarm OR due to unexplained hyperglycemia with blood glucose (SMBG) >250mg/dL (13.9 mmol/L) that does not decrease within 1 hour following a correction bolus delivered via the pump.|6 Weeks|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2530764|NCT03374189|Secondary|Number of Participants With Visceral Organ Injury|Any inadvertent injury to organs or bleeding during procedure.|At the time of surgery||||Participants|||Count of Participants
2529749|NCT03433677|Primary|Rate of Infusion Set Failures|Infusion set failure events are defined as premature infusion set changes, due to a pump occlusion alarm OR due to unexplained hyperglycemia with blood glucose (SMBG) >250 milligrams per deciliter (mg/dL) (13.9 millimoles per liter [mmol/L]) that does not decrease within 1 hour following a correction bolus delivered via the pump during the 6 week treatment period. Aggregate rate was calculated for each participant as the total number of events while the participant is on study treatment divided by the days of exposure [last dose date and time -first dose date and time -duration of pump or treatment interruption] times 30.|6 Weeks|All randomized participants who received at least 1 dose of study drug.|||events per 30 participant days|||Number
2529750|NCT03432533|Secondary|Number of Participants Developing Anti-Romosozumab Antibodies|Participants with a negative or no result at baseline (BL) developing anti-romosozumab antibodies postbaseline, including those who were binding antibody-positive or neutralizing antibody-positive postbaseline. 'Transient' positive results are those with a negative result at the participant's last time point tested within the study period.|up to Month 9 (-7/+3 days)|Safety Analysis Set: all randomized participants who received at least 1 dose of study drug as well as baseline and postbaseline antibody results.|||Participants|||Count of Participants
2529751|NCT03432533|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths|AE: any untoward medical occurrence irrespective of a causal relationship with the study treatment. SAE: any untoward medical occurrence that meets at least 1 of the following criteria: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important serious event. Adverse device effect: any AE related to the use of a combination product or medical device. TEAEs are those AEs occurring after first dose of study drug.|up to Month 9 (-7/+3 days)|Safety Analysis Set: all randomized participants who received at least 1 dose of study drug|||participants|||Number
2529752|NCT03432533|Secondary|Percent Change From Baseline in Femoral Neck BMD at Month 6|Percent change from baseline in BMD at femoral neck as measured by DXA.|Baseline, Month 6|Primary Analysis Population: participants with lumbar spine BMD values at baseline and >=1 postbaseline visit at Month 6.|||percent change||Standard Error|Least Squares Mean
2529753|NCT03432533|Secondary|Percent Change From Baseline in Total Hip BMD at Month 6|Percent change from baseline in BMD for total hip as measured by DXA.|Baseline, Month 6|Primary Analysis Population: participants with lumbar spine BMD values at baseline and >=1 postbaseline visit at Month 6.|||percent change||Standard Error|Least Squares Mean
2529754|NCT03432533|Primary|Percent Change From Baseline in Lumbar Spine BMD at Month 6|Percent change from baseline in BMD at the lumbar spine as measured by dual-energy x-ray absorptiometry (DXA).|Baseline, Month 6|Primary Analysis Population: participants with lumbar spine BMD values at baseline and >=1 postbaseline visit at Month 6.|||percent change||Standard Error|Least Squares Mean
2529755|NCT03432390|Secondary|Number of Participants That Experienced Complications While Undergoing General Anesthesia|In children undergoing general anesthesia for elective surgery who will undergo CPAP or standard circular circuit ventilation during anesthesia induction, compare: The frequency of complications (laryngospasm, hypoxemia, bradycardia, cardiorespiratory arrest, death) between the groups|During induction of general anesthesia (up to five minutes after beginning of apnea)||||Participants|||Count of Participants
2529756|NCT03432390|Secondary|Time to Recovery of Oxyhemoglobin Saturation Levels in Pre-apnea Pulse Oximetry|In children undergoing general anesthesia for elective surgery who will undergo CPAP or standard circular circuit ventilation during anesthesia induction, compare: The time to recovery of oxyhemoglobin saturation levels in pre-apnea pulse oximetry between groups|During induction of general anesthesia (up to five minutes after beginning of apnea)||||Seconds||95% Confidence Interval|Mean
2529757|NCT03432390|Primary|Time Between Onset of Apnea and the Drop in 95% Oxyhemoglobin Saturation Levels|In children undergoing general anesthesia for elective surgery who will undergo CPAP or standard circular circuit ventilation during anesthesia induction, compare the time between onset of apnea and the drop in 95% oxyhemoglobin saturation between the groups|During induction of general anesthesia (up to five minutes after beginning of apnea)||||seconds||95% Confidence Interval|Mean
2529758|NCT03431441|Primary|LogMAR Objective Vision (High Illumination/High Contrast)|Monocular high illuminance high contrast VA with the study lenses was collected to the nearest letter using computer generated logMAR charts. 0.02 logMAR is equivalent to 1 letter. Negative logMAR values indicate better lens performance. The average visual acuity was reported for each lens type.|5 minutes after lens fitting|All subjects who received at least one study article regardless of the randomization status.|||logMAR|Eyes|Standard Deviation|Mean
2529759|NCT03431012|Secondary|Perceived Response Costs|Measured by self-report items adapted from Godinho et al. (2016): participants were asked to agree with four statements about their beliefs about the side effects and negative consequences of using antivirals on 9-point scale, from 1=strongly disagree to 9=strongly agree. Higher scores indicate higher levels of perceived response costs. This is a composite variable reflecting the average of the items that compose it.|At 20 minutes (i.e. straight after exposure to the health messages)|Based on the literature, we predicted that Positive framing of the side effects would lead to lower response costs compared to the Negative Framing. To test our hypothesis about differences between PF conditions and NF conditions, in this analysis we combined the VAPF and HAPF groups on one hand and the VANF and HANF groups on the other.|||score on a scale||Standard Deviation|Mean
2529760|NCT03431012|Secondary|Perceived Efficacy of the Antivirals|Measured by two self-report items (adapted from Godinho et al. (2016): participants were asked to agree with two statements about their perception of the efficacy of the antivirals against pandemic flu on 9-point scale, from 1=strongly disagree to 9=strongly agree. Higher scores indicate higher levels of perceived efficacy of the antivirals. This is a composite variable reflecting the average of the items that compose it.|At 20 minutes (i.e. straight after exposure to the health messages)|Based on the literature, we predicted that Positive framing of the side effects would lead to higher response efficacy compared to the Negative Framing. To test our hypothesis about differences between PF conditions and NF conditions, in this analysis we combined the VAPF and HAPF groups on one hand and the VANF and HANF groups on the other.|||score on a scale||Standard Deviation|Mean
2546643|NCT02918552|Other Pre-specified|Cardiopulmonary Exercise Testing: iCPET|Invasive cardiopulmonary exercise testing|Week 3 (pre-drug) to week 10 (post drug); approx. 8 weeks|||||||
2529761|NCT03431012|Secondary|Perceived Self-efficacy|Measured by one self-report item (adapted from Witte et al. (2001): participants were asked to agree with a statement about their perceived ability to take the antivirals as recommended on 9-point scale, from 1=strongly disagree to 9=strongly agree. Higher scores indicate higher levels of reported self-efficacy.|At 20 minutes (i.e. straight after exposure to the health messages)|Based on the literature, we predicted that the Agency Assignment (i.e. VA vs. HA) would not affect self-efficacy measures. To test our hypothesis, in this analysis we combined the VANF and VAPF groups on one hand and the HANF and HAPF groups on the other.|||score on a scale||Standard Deviation|Mean
2529762|NCT03431012|Secondary|Perceived Severity of the Pandemic|Measured by one self-report item (adapted from Witte et al. (2001): participants were asked to agree with a statement about their perception of the severity of the pandemic flu on 9-point scale, from 1=strongly disagree to 9=strongly agree. Higher scores indicate higher levels of perceived severity of the pandemic flu threat.|At 20 minutes (i.e. straight after exposure to the health messages)|Based on the literature, it was predicted that the Virus Agency would lead to higher perceptions of severity of the pandemic than the Human Agency assignment. To test our hypothesis about differences between VA conditions and HA conditions, in this analysis we combined the VANF and VAPF groups on one hand and the HANF and HAPF groups on the other.|||score on a scale||Standard Deviation|Mean
2529763|NCT03431012|Secondary|Perceived Susceptibility to the Pandemic Flu|Measured by self-report items: participants were asked to state how likely they were to get sick with pandemic flu, had they not taken prophylactic medication o a 9-point scale, where 1=not likely at all, to 9=extremely likely.|At 20 minutes (i.e. straight after exposure to the health messages)|Based on the literature, it was predicted that the Virus Agency would lead to higher perceptions of susceptibility than the Human Agency assignment. To test our hypothesis about differences between VA conditions and HA conditions, in this analysis we combined the VANF and VAPF groups on one hand and the HANF and HAPF groups on the other.|||score on a scale||Standard Deviation|Mean
2529764|NCT03431012|Secondary|Worry of the Pandemic Flu Threat|Measured by self-report items adapted from Witte et al. (2001): participants were asked to agree with two statements about their perceived worry on 9-point scale, from 1=strongly disagree to 9=strongly agree. Higher scores indicate higher levels of reported worry about pandemic flu threat. This is a composite variable reflecting the average of the items that compose it.|At 20 minutes (i.e. straight after exposure to the health messages)|Based on the literature, it was predicted that the Virus Agency (main effect) would lead to higher worry than the Human Agency assignment. To test our hypothesis about differences between VA conditions and HA conditions, in this analysis we combined the VANF and VAPF groups on one hand and the HANF and HAPF groups on the other.|||score on a scale||Standard Deviation|Mean
2529765|NCT03431012|Primary|Change in Intentions to Take Antivirals for Pandemic Flu|Mean adherence intentions post- exposure to the health information in the 4 groups. Intentions were measured by self-report items: participants were asked to agree with three statements about their intentions to take antivirals as recommended in the hypothetical scenario (on 9-point scale, where 1=strongly disagree to 9=strongly agree). The scores reported below represent a composite variable 'change in intentions', which reflects the average of the three items that compose it.|Straight after exposure to the health messages|ANCOVAs, setting baseline intentions as a covariate, were performed to determine whether post-exposure mean adherence intentions differed between groups.|||score on a scale||Standard Deviation|Mean
2529766|NCT03430245|Secondary|Subject Satisfaction|Subject satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (at 4, 8 and 12 weeks after the last treatment visit).|At 4, 8 and 12 week follow-up visits|6 subjects were initially treated, but then were lost to follow-up during the period when the treatment protocol was amended. One other subject was lost to follow-up after three treatments because she was unable to come in for visits due to work schedule.|||Participants|||Count of Participants
2529767|NCT03430245|Secondary|Investigator Satisfaction|Investigator satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (4, 8 and 12 weeks after the last treatment)|At 4, 8 and 12 weeks follow-up visits|6 subjects were initially treated, but then were lost to follow-up during the period when the treatment protocol was amended. One other subject was lost to follow-up after three treatments because she was unable to come in for visits due to work schedule.|||Participants|||Count of Participants
2529768|NCT03430245|Secondary|Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits|"The thighs circumference change (at midline) after combined treatment with VelaShape III and UltraShape Power treatments compared to baseline.~The changed of thighs circumference was calculated at 2, 4, 8 and 12 weeks after baseline (which are second treatment , third treatment, 4 and 8 week follow-up visits, respectively).~Negative change represent reduction in thigh circumference."|At 2, 4, 8 and 12 weeks after baseline|6 subjects were initially treated, but then were lost to follow-up during the period when the treatment protocol was amended. One other subject was lost to follow-up after three treatments because she was unable to come in for visits due to work schedule.|||centimeter|Number of Thighs|Standard Deviation|Mean
2529769|NCT03430245|Primary|Circumference Change in the Thighs at the 12-week Follow-up Compared to Baseline Measurements|Circumference change of thigh midline post combined VelaShape III and UltraShape Power treatments. Negative change represent reduction in thigh circumference.|At 12 weeks after the third treatment (week 16) for each subject|6 subjects were initially treated, but then were lost to follow-up during the period when the treatment protocol was amended. One other subject was lost to follow-up after three treatments because she was unable to come in for visits due to work schedule|||centimeter|Number of thighs|Standard Deviation|Mean
2529770|NCT03430050|Primary|Change in Cannabis Withdrawal Scale Score.|Participants took progesterone or placebo for 5 days. The Cannabis Withdrawal Scale was administered each day. The 19-item scale is used to measure cannabis withdrawal symptoms and negative impact on daily life. The item scores range from 0 - not at all to 10- Extremely. Scores on all items are summed to attain the scale score, so individuals can score between 0-190. Higher scores indicates more severe withdrawal symptoms and greater negative impact. Change score was calculating by subtracting Day 1 CWS scores from Day 5 CWS scores. A positive change score reflects an increase in withdrawal symptoms, while a negative change score reflects a decrease in withdrawal symptoms.|Day 1 and Day 5||||units on a scale||Standard Error|Mean
2529774|NCT03429556|Secondary|Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories|The participant assessed their overall pain control in the past 24 hours using the PGA 4-point scale where: 0=poor, 1=fair, 2=good and 3=excellent.|Days 5, 8, 15 and 29|mITT population included all randomized and treated participants with at least one post-injection pain score.|||Participants|||Count of Participants
2529775|NCT03429556|Secondary|Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A)|The participant assessed their pain using the 11-point NPRS-A, after sitting up in the bed unassisted at an angle of approximately ≥ 45 degrees, swinging legs out, putting feet down, standing up, and walking approximately 10 feet, where: 0=no pain to 10=worst pain imaginable.|8, 16, 24, 30, 36, 42, 48, 54, 60, 66, 72.78.84, and 96 hours after surgery; Days 8, 15 and 29 after discharge|mITT population included all randomized and treated participants with at least one post-injection pain score. Participants analyzed is the number of participants with data available for analysis at the given time point.|||score on a scale||Standard Deviation|Mean
2529776|NCT03429556|Secondary|Participants Overall Assessment of Pain Using the NPRS After Discharge|The participant assessed their pain after discharge using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable.|Days 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24 and 26|mITT population included all randomized and treated participants with at least one post-injection pain score.|||score on a scale||Standard Deviation|Mean
2529777|NCT03429556|Secondary|AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 12 and 24 Hours Postsurgery (AUC12-24)|The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.|Every 2 hours from 12 to 24 hours postsurgery|mITT population included all randomized and treated participants with at least one post-injection pain score.|||hr*score on a scale||Standard Deviation|Mean
2529778|NCT03429556|Secondary|AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 24 Hours Postsurgery (AUC0-24)|The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.|Every 2 hours from 0 to 24 hours postsurgery|mITT population included all randomized and treated participants with at least one post-injection pain score.|||hr*score on a scale||Standard Deviation|Mean
2529779|NCT03429556|Secondary|AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 48 Hours Postsurgery (AUC0-48)|The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.|Every 2 hours from 0 to 48 hours postsurgery|mITT population included all randomized and treated participants with at least one post-injection pain score.|||hr*score on a scale||Standard Deviation|Mean
2529780|NCT03429556|Secondary|AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 72 Hours Postsurgery (AUC0-72)|The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.|Every 2 hours from 0 to 72 hours postsurgery|mITT population included all randomized and treated participants with at least one post-injection pain score.|||hr*score on a scale||Standard Deviation|Mean
2529781|NCT03429556|Secondary|AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 96 Hours Postsurgery|The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.|Every 2 hours from 0 to 96 hours postsurgery|mITT population included all randomized and treated participants with at least one post-injection pain score.|||hr*score on a scale||Standard Deviation|Mean
2529782|NCT03429556|Primary|Area Under the Curve (AUC) of Participant's Assessment of Pain Using the Numerical Pain Rating Scale (NPRS) at Rest Between 12 and 96 Hours Postsurgery (AUC12-96)|The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.|Every 2 hours from 12 to 96 hours postsurgery|Modified Intent-to-treat (mITT) population included all randomized and treated participants with at least one post-injection pain score.|||hour (hr)*score on a scale||Standard Deviation|Mean
2529783|NCT03428997|Primary|Microcomedone Score of Follicular Biopsies|"Grades for irritations/reactions were The following 5-point global assessment scale was used to grade the follicular biopsies for microcomedones: 0 None (0% No microcomedones) 0.5 Slight (1-24% Smallish horny masses)~Mild (25-49% Smallish horny masses)~Moderate (50-74% Moderately sized horny masses)~Severe (75-100% Larger globoid microcomedones)"|28 days|All study participants received both the test product and a negative control following a randomization.|||microcomedone score|Test Site|Standard Deviation|Mean
2529784|NCT03428152|Secondary|Number of Participants With Complications Due to SHP Block|intra/postoperative complications will be noted. (post-operative nausea and vomiting (PONV) or others: ie: intra-vascular local anesthetic injection, vascular puncture, hemodynamical changes after injection,.. )|From the SHP block time (intraoperative) until discharge||||Participants|||Count of Participants
2529785|NCT03428152|Secondary|Length of Hospital Stay|length of hospital stay time will be recorded|assessed up to 1 week||||days||Standard Deviation|Mean
2529786|NCT03428152|Secondary|Duration of Operation|the time from the the first incision to the skin to skin closure.|from the induction of anesthesia and the end of the surgery||||minutes||Standard Deviation|Mean
2529787|NCT03428152|Secondary|Rescue Analgesic Time|Time to first analgesic demand at gynecology ward (after transfer from PACU to gynecology ward)|48 hours (time to the first analgesic demand will be recorded)||||minutes||Standard Deviation|Mean
2529788|NCT03428152|Primary|Postoperative Analgesic Consumption|"Total number of non-steroid anti-inflammatory drug (NSAID) and opioid vials that are applied to patients in post-anesthesia care unit (PACU) and at ward will be recorded.~Target VAS score for NSAID is >4; if there is no response to NSAID and pain is worsening opioid drugs will be applied (this is our routine clinical practice) NSAID: Diclofenac sodium 75mg per vial; opioid: Tramadol 100mg per vial."|postoperative 48 hour follow-up (PACU and ward)||||vials||Standard Deviation|Mean
2529812|NCT03426631|Primary|Apnea Hypopnea Index (AHI, Events/Hour of Sleep)|Based on previous studies the investigators anticipate that DAW1032B2 will reduce AHI more effectively in subjects with moderate sleep apnea, mildly obese (BMI<32), Vpassive > 50% of Veupnea (ventilation during eupneic ventilatory drive)|1 night||||events/hour of sleep||Inter-Quartile Range|Median
2529813|NCT03426566|Secondary|BMI|kg/m2|1 visit|Patients after BMI were assigned to one of two groups : BMI<35 kg/m2 or ≥35 kg/m2|||Participants|||Count of Participants
2529789|NCT03428152|Primary|Postoperative Pain Scores|Patients' pain scores will be scored with a 10 cm Visual Analogue Scale (VAS). Each will be scored between 0-10 (0: no pain; 10: worst pain ever) (PACU: Post-anesthesia care unit) VAS-PACU: VAS scores at PACU VAS 1: VAS scores at postoperative 1st hour (ward) VAS 6: VAS scores at postoperative 6th hour (ward) VAS 12: VAS scores at postoperative 12th hour (ward) VAS 24: VAS scores at postoperative 24th hour (ward) VAS 48: VAS scores at postoperative 48th hour (ward)|postoperative 48 hour follow-up (PACU and ward)|37 patients with a superior hypogastric block (7 was excluded); 41 patients without a superior hypogastric block (11 was excluded).|||units on a scale||Standard Deviation|Mean
2529790|NCT03427892|Other Pre-specified|High Sensitivity C-Reactive Protein (Hs-CRP)|high sensitivity C-Reactive Protein values will be used to measure inflammation|Baseline and at week 8||||mg/L||Standard Deviation|Mean
2529791|NCT03427892|Secondary|The Inventory of Depressive Symptomatology Self-Report (IDS-SR30)|An 30 item inventory self report assessing depressive symptoms and mood, within the past seven days. With the score range of 0-90 with higher scores indicating worse outcome.|Baseline through week 8||||score on a scale||Standard Deviation|Mean
2529792|NCT03427892|Secondary|Quality of Life in Bipolar Disorder (QOLBD)|"The Quality Of Life in Bipolar Disorder (QOLBD) is a measure of the quality of life in patients with bipolar disorder. All questions on the scale ask about a range of experiences, behaviors, and feeling related to the quality of life. For each question, a participant is asked to indicate how much they agree with each question. The scale consists of 12 questions, with each question measured on a 5-point scale, such as strongly disagree - 1, disagree - 2, neutral - 3, agree - 4, strongly agree - 5. The total possible range of scores on the scale is 12-60. Higher scores indicate better quality of life."|Baseline and at week 8||||score on a scale||Standard Deviation|Mean
2529793|NCT03427892|Secondary|Simpson Angus Scale|The Simpson Angus Scale (SAS) measured drug-induced movement side effects. There are 10 items on the scale, with each item scored on a scale of 0-4 (least to most severe). The total possible range of scores across all items is 0-40, with higher scores indicative of worse outcome.|Baseline through week 8||||score on a scale||Standard Deviation|Mean
2529794|NCT03427892|Secondary|Barnes Akathisia Scale|The Barnes Akathisia Scale (BAS) is an assessment of movements to determine any short-term drug-induced movement disorders. There are 5 items.Items 1-3 are rated from a scale of 0-3 with 0 indicating the least severity, and 3 indicating the highest severity of symptoms. Item 4 is a global assessment of symptoms assessed and the severity is assessed on a scale of 0-5, with 0 indication least severity and 5 indicating the most severity.The total score is the sum of all the item scores (scores ranging from 0-14).With higher scores reflecting worse outcome.|Baseline through week 8||||score on a scale||Standard Deviation|Mean
2529795|NCT03427892|Secondary|Abnormal Involuntary Movement Scale|The Abnormal Involuntary Movement Scale (AIMS) is an assessment of movements to determine any long-term drug induced movement disorders.There are 10 items on the scale with scores ranging from 0-4 (0 None/Normal, 1 minimal, 2 mild, 3 moderate,4 severe). 4 items assess facial and oral movements, 2 items measure extremity movements, 1 item measures trunk movements, and 3 items measure global judgments regarding symptoms assessed. A total score is the sum of scores for items assessing facial and oral movements, extremity movements, and trunk movement (scores ranging from 0-28), with 0 being the lowest score, and 28 being the highest score. A higher score is indicative of a higher severity in symptomatology.|Baseline through week 8||||score on a scale||Standard Deviation|Mean
2529796|NCT03427892|Secondary|Columbia Suicide Severity Rating Scale|The Columbia Suicide Severity Rating Scale (C-SSRS) is a structured interview and rating scale used to measure suicidal thoughts and behaviors. Actual attempts, interrupted attempts, and aborted attempts are measured as positive integers (zero and above). The minimum value for the actual, interrupted, and aborted attempt is zero (reflecting no past suicidal behavior). There is no maximum scale value, as the number of attempts differs for each participant. The entered values represent the average number of actual, interrupted, and aborted attempts in the group. Higher values reflect a higher number of attempts experienced by each participant (equivalent to a worse outcome).|Baseline through week 8||||attempts||Standard Deviation|Mean
2529797|NCT03427892|Secondary|Systematic Assessment For Treatment Emergent Events|"The Systematic Assessment for Treatment Emergent Effects (SAFTEE) is a self-report scale used in clinical trials and is designed to evaluate the degree to which each possible side effect is bothersome to a participant. There are 55 items on the scale (each item represents a different side effect), with each item rated on a 4-point scale such as not bothersome - 0 (zero), mildly bothersome - 1, moderately bothersome - 2, severely bothersome - 3. The total possible range of scores on the scale is 0-165. The higher scores indicate a higher degree of being bothered by various side effects."|Baseline through week 8||||score on a scale||Standard Deviation|Mean
2529798|NCT03427892|Secondary|Trail Making Test (TMT)|The Trail Making Test (TMT) measures attention, speed, and accuracy. TMT consists of two parts: Trails A and Trails B. The performance on each test is measured in seconds and represents how quickly a participant can connect the numbers (Trails A) and the numbers and letters (Trails B) together. The number of seconds it takes to complete each part of TMT is converted to a T-score based on gender, age, race, and education. The T-scores range from 0-100 with higher scores indicating better (faster) performance. The entered data are presented as T-Scores.|Baseline through week 8||||T-scores||Standard Deviation|Mean
2529799|NCT03427892|Secondary|Stroop Task|The Stroop task evaluates attention, speed, and accuracy of thinking. Stroop task consists of three separate trials: word, color, and color-word (CW) naming. For each trial, a raw score (correct number of words named) is recorded. The raw score for each trial is converted to a T-score based on participant's age and education level. The possible T-scores range from 15-85 for the word trial, 8-92 for the color trial, and 3-98 for the color-word trial. The interference score (Inter) is also derived from the color-word score, with T-scores ranging from 21-80. Higher numbers indicate better performance. The entered values represent T-scores.|Baseline through week 8||||T-scores||Standard Deviation|Mean
2529811|NCT03426787|Primary|Change in Knowledge|The percent correct out of eight questions created by the research team based on information that is considered vital to making treatment decisions, including understanding HCV and CKD, the health effects of both diseases, and understanding factors that differentiate treatment options. Scores range from 0 to 100. Higher scores demonstrate more knowledge.|At baseline and immediately after viewing the intervention, within 30 minutes.|Participants completed both pre and post-test survey questions for the knowledge questions.|||percentage of correct responses||Standard Deviation|Mean
2529800|NCT03427892|Secondary|Rey Auditoy Verbal Learning Test|Rey Auditory Verbal Learning Test (RAVLT) is a test of verbal learning and declarative memory. During the test, 15 nouns that are read aloud for 5 consecutive trials. Each trial is followed by a free recall test (participant is asked to recall the words that were just read to them). The sum of correctly recalled words across 5 trials is called the total raw score. On completion of Trial 5, an interference list of 15 words (List B) is presented, followed by a free recall test of that list. After a 20-min delay, the examinee is again required to recall the words from list A - this is called the delay raw score. The raw scores on both the total recall and the delay trials (number of words correct across trials 1-5) are converted to standardized T-scores (Mean=50; SD=10; range 20-100) based on participant age and gender. The scores below are presented as T-scores, with higher scores indicative of better performance.|Baseline through week 8||||T-scores||Standard Deviation|Mean
2529801|NCT03427892|Secondary|Young Mania Rating Scale (YMRS)|Young Mania Rating Scale is an observer-rated measure of mania symptoms. It has 11 items and each items has 5 defined anchor points with increasing severity that describe the symptom characteristics. YMRS is scored by taking sum of the scores for the 11 items. A higher score indicative of more acute manic symptoms. Seven of the items are scored between 0 and 4. Four items allow for scoring between anchor points (ranging 1 to 8). Maximum score is 60 and minimum score is 0.|Baseline through week 8||||score on a scale||Standard Deviation|Mean
2529802|NCT03427892|Primary|The Montgomery-Asberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating Scale is used to assess depressive symptom severity. There are 10 items and each item is rated from 0 to 6 (increasing severity) based on the assessment of symptoms within the past 7 days. Scoring is assisted by descriptive anchors that serve as useful guides at 0,2,4, 8. Odd numbers (1,3,5) between the descriptive anchors are also meant to be scored. Highest possible MADRS score is 60. Lowest possible MADRS score is 0. MADRS is scored by taking the sum of the scores for each item. A higher score is indicative of more acute depressive symptoms.|Baseline through week 8||||score on a scale||Standard Deviation|Mean
2529803|NCT03427073|Secondary|Pharmacokinetics: Cmax|Cmax was derived from the individual patient plasma concentration of ALM201.|Cmax of ALM201 following subcutaneous (SC) administration of ALM201 was determined in cycles 1, 2, 4 and 6 of treatment|Reporting group|||ng/mL||Full Range|Geometric Mean
2529804|NCT03427073|Secondary|Pharmacokinetics: AUC 0-t|AUC 0-t was derived from the individual patient plasma concentration versus time profiles of ALM201.|AUC 0-t was determined in cycles 1, 2, 4 and 6 of treatment|Reporting group|||ng*h/mL||Full Range|Geometric Mean
2529805|NCT03427073|Secondary|Pharmacokinetics: Tmax|Tmax was derived from the individual patient plasma concentration versus time profiles of ALM201.|Tmax was determined in cycles 1, 2, 4 and 6 of treatment|Reporting group|||hour||Full Range|Median
2529806|NCT03427073|Secondary|Tumour Response Assessment - Best Overall Response|As this was a Phase 1 study, the extent of efficacy data was expected to be limited. Using RECIST Version 1.1, a summary of clinical benefit from patients with evaluable disease was generated via CT scans: Complete Response (CR) = Disappearance of all target & non-target lesions + normalization of tumor marker; Partial Response (PR) ≥ 30% decrease in the sum of LD of target lesions; Progressive Disease (PD) ≥ 20% increase (& 5mm absolute increase) in sum of LD of target lesions or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions; Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|Response assessments were done to assess clinical benefit in the efficacy population overall and at the end of cycles 2, 4 and 6, as applicable|Reporting group|||participants|||Number
2529807|NCT03427073|Primary|Safety and Tolerability - Evaluation of AEs and DLT|"All events and suspected dose limiting toxicities (DLTs) were graded according to the CTCAE, version 4.03. A DLT was defined as a Grade 3 or 4 AE that, in the opinion of the CRC, was likely to be related to ALM201 and represented a clinically significant hazard to the patient. Qualifying DLT events were considered to be clinically relevant; e.g. in duration, apparent reversibility, required management, and upon consideration of the patient's medical history and/or concomitant medications. DLT events were also evaluated in terms of what was considered to be an appropriate next escalation step: In the case where the CRC agreed that an escalation step of approximately 33% or lower was merited; the toxicity of concern could be declared a DLT.~In order to be evaluable for DLT assessment, a patient had to receive at least 80% of their scheduled doses (e.g. 12 of the 15), unless this lack of compliance was due to ALM201-related toxicity."|Adverse event evaluation was done during treatment and follow-up. DLT evaluation was done during cycle 1|Reporting group|||participants|||Number
2529808|NCT03426787|Secondary|System Usability Scale|A 10-item scale that evaluates the website's usability level. Scores can range from 0 to 100. An average score of 68 is considered a usable/adequate tool per measure guidelines. Higher scores represent better usability level for the tool.|Completed immediately after viewing the intervention|Participants completed the system usability scale in our post-test questionnaire.|||score on a scale||Standard Deviation|Mean
2529809|NCT03426787|Primary|Change in Decision Self-Efficacy Scale|The validated decision self-efficacy scale will be used. This 11-item scale measures an individual's self-confidence or belief in their ability to make a decision. Individuals will be asked to rate how confident they feel taking actions involved in making an informed choice (e.g., gathering information, asking questions, and expressing opinions). Scores can range from 0 to 100. Higher scores indicate more confidence in participants ability to make a treatment choice.|At baseline and immediately after viewing the intervention, within 30 minutes.|Participants completed both pre and post-test survey questions for the decision self-efficacy scale.|||score on a scale||Standard Deviation|Mean
2529810|NCT03426787|Primary|Change in Decisional Conflict Scale|The validated, 4-item SURE Test for clinical practice will be used. This scale measures whether individuals feel they have enough information to make a choice, are clear about their values for risks and benefits of their choice and feel they have enough support to make a choice. Scores range from 0 to 4. Higher scores indicate more confidence in their choice.|At baseline and immediately after viewing the intervention, within 30 minutes.|Participants completed both pre and post-test survey questions for the decisional conflict scale.|||score on a scale||Standard Deviation|Mean
2529849|NCT03421730|Secondary|Changes in Vital Signs (Blood Pressure)|Mean values for blood pressure from pre-dose to 0.5 hours post-dose.|Baseline to Day 1 0.5 hours post-dose||||mm Hg||Standard Deviation|Mean
2529814|NCT03426566|Secondary|Number of Participants With Positive Test for Neuropathy|Peripheral neuropathy is assessed with questions and clinical evaluation. A nurse asks the patient about stinging, numbness, tingling, or burning of the foot. Ten-gram monofilament and tuning fork (128 MHz) tests are administered. Monofilament is applied in 10 locations on the sole and one on the dorsal part of the foot for checking the loss of protective sensation. A positive monofilament test is considered to be the lack of sensation of tightness in at least 6 of 11 tested sites. The tuning fork is applied for vibration detection to both ankles, the first metatarsophalangeal joint, and the anterior aspect of the shin bone sites. A positive vibration test is considered to be no detection of vibration in three of four test sites.Two positive test results and typical symptoms of neuropathy are the basis for confirmation of peripheral symmetric sensory neuropathy (PSSN). The condition required for the occurrence of these disorders was symmetry.|1 visit|Patients with DM, without active or past ulcer or surgery within the feet.The data was collected, grouped and analyzed separately for: PSSN, motor neuropathy (MN): MN-Calluses and MN-Feet deformity. One patient can developed PSSN and calluses and feet deformity (and thus his/her result was incorporated into each arm) or one of these variables.|||Participants|||Count of Participants
2529815|NCT03426566|Primary|Abnormal Plantar Pressure Distribution|static pedobarographic test with semi-quantitative assessment: number of the patients with abnormal plantar pressure location based on a semi-quantitative method, as static barefoot pedobarographic records with colourful print analysis. The intensity of colour was proportional to the pressure received. Warm colours indicated the greatest pressure, while cold colours indicated the least plantar pressure (starting with red, then yellow, green, and blue)|1 visit|Patients with diabetes mellitus but without active or past foot ulcer or surgical procedure within the feet. Abnormal plantar pressure distribution (APD) - means number of participants with symmetrical abnormal pressure distribution; No APD- without such kind a distribution.|||Participants|||Count of Participants
2529816|NCT03426436|Primary|Kappa Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion|Kappa value for comparison of actual 18-lead ECG vs synthesized ECG leads. All measures at 95% confidence Index.|30 minutes||||Kappa||95% Confidence Interval|Number
2529817|NCT03426436|Primary|Sensitivity and Specificity Agreement Between Synthesized and Actual 18-lead ECGs in the Identification of ST Elevation, ST Depression, and T Wave Inversion|Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value for comparison of actual 18-lead ECG vs synthesized ECG leads. All measures at 95% confidence Index.|30 minutes||||percentage of participants||95% Confidence Interval|Number
2529818|NCT03426137|Other Pre-specified|Requests of Rescue Intervention|IV Dilaudid will be provided upon request as a rescue medication. The frequency of these requests will be assessed during hospitalization.|Day 1-7|||||||
2529819|NCT03426137|Secondary|Functional Pain Scores - Follow-up|The patient's subjective rating of pain and the objective determination of the pain's interference with activities will produce a corresponding score on a scale of 0-5.|Day 1-7, Week 2|||||||
2529820|NCT03426137|Secondary|Pain Self-reports - Follow-up|"Collected on a visual analogue scale, with 0 being no pain and 100 being maximum pain tolerable"|Day 1-7, Week 2|||||||
2529821|NCT03426137|Secondary|Long-term Prescriptions and Use of Opioids Over the Follow-up Period|Collected information about participants' long term opioid use in order to evaluate the effectiveness of each Arm's Intervention on reducing the need for opioid prescriptions and the use of opioids.|Day 1-7, Week 2|||||||
2529822|NCT03426137|Secondary|Pain Catastrophizing Scale (PCS)|Assessment of catastrophizing thoughts|Day 1-7, Week 2|||||||
2529823|NCT03426137|Secondary|Pain Intensity Enjoyment of Life and General Activity (PEG)|Three item scale for pain and its interference|Day 1-7, Week 2|||||||
2529824|NCT03426137|Secondary|Adapted Credibility/Expectancy|Assessment of credibility about treatment|Day 1-7, Week 2|||||||
2529825|NCT03426137|Secondary|Fear of Pain Questionnaire (FPQ)|Assessment of different forms of fear|Day 1-7, Week 2|||||||
2529826|NCT03426137|Secondary|Mood/Depression|Mood/Depression Assessment|Day 1-7, Week 2|||||||
2529827|NCT03426137|Secondary|Beck Depression Inventory (BDI)|Depression Anxiety Assessment|Day 1-7, Week 2|||||||
2529828|NCT03426137|Secondary|State and Trait Anxiety Inventory (STAI-Y1, STAI-Y2)|State and Trait Anxiety assessment|Day 1-7, Week 2|||||||
2529829|NCT03426137|Primary|Pain Self-reports|"Collected on a visual analogue scale, with 0 being no pain and 100 being maximum pain tolerable"|Day 1-7, Week 2, Months 1, 3 and 6|"All three participants gave written consent to participate in the study and signed the HIPAA form, but withdrew before starting any study procedures. These 3 withdrawals were handled per protocol. As is written in the consent, You are free to withdraw your consent at any time. Therefore, there was no analyzable data collected."||||||
2529830|NCT03423641|Primary|Incidence of HBV Reactivation|We identified HBV reactivations in three different ways [Di Bisceglie et al., 2015; Yanny et al., 2018]: (1) patients who had a history of Hepatitis B core antibody (HBcAb) positive and were Hepatitis B surface antigen (HBsAg) negative at the time of initiating DAA therapy who became HBsAg positive within 180 days after receiving a DAA; (2) patients with undetectable levels of HBV DNA at the time of initiating DAA therapy who had a numerical result within 180 days after receiving a DAA; (3) patients with a numerical HBV DNA result at the time of initiating DAA therapy whose viral load increased by a factor of 10 within 180 days after receiving a DAA. For all methods of detecting a reactivation, we required that the reactivations be clinically significant: bilirubin at least 3, aspartate aminotransferase (AST) at least 400, or alanine aminotransferase (ALT) at least 500.|Labs will be for up to 180 days following the initiation of a DAA.|At the time of initiating DAA therapy, at least one of the following had to be true (1) Hepatitis B core antibody (HBcAb) positive and Hepatitis B surface antigen (HBsAg) negative (2) Hepatitis B core antibody (HBcAb) positive and undetectable levels of HBV DNA; (3) numerical HBV DNA result|||Participants|||Count of Participants
2529831|NCT03423641|Primary|Incidence of Cancers Other Than Liver Cancer|Encounters with ICD-9 codes 140.xx through 208.xx, except 155.xx or ICD-10 coes C00-C97 except C22.xx.|Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.|The analysis population consists of the subset of patients without a prior diagnosis of cancer.|||Events per 1000 person years||95% Confidence Interval|Number
2546644|NCT02918552|Other Pre-specified|Brain Natriuretic Protein|Change in brain natriuretic protein (BNP)|Week 5 (pre drug) to week 16 (post drug); approx. 8 weeks|||||||
2529832|NCT03423641|Primary|Incidence of Liver Cancer|Encounters with ICD-9 diagnosis code of 155.xx or ICD-10 code of C22.xx.|Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.|The analysis population consists of the subset of patients without a prior diagnosis of liver cancer.|||Events per 1000 person years||95% Confidence Interval|Number
2529833|NCT03423641|Primary|Incidence of Arrhythmia|Inpatient encounters with an ICD-9 diagnosis code of 427.1, 427.42, 427.5, 427.9 or an ICD-10 diagnosis code of I47.2, I49.01, I49.02, I46.9, I49.9.|Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.|The analysis population consists of the subset of patients without a past diagnosis of arrhythmia.|||Events per 1000 person years||95% Confidence Interval|Number
2529834|NCT03423641|Primary|Rate of Emergency Department Visits|An encounter in which the place of service is an emergency department or urgent care center.|ED visits will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.|The analysis population is the same as the baseline population.|||Events per 1000 person years||95% Confidence Interval|Number
2529835|NCT03423641|Primary|Rate of Hospitalizations|An encounter in which the place of service is an inpatient hospitalization.|Hospitalizations will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.|The analysis population is the same as the baseline population.|||Events per 1000 person years||95% Confidence Interval|Number
2529836|NCT03423641|Primary|Incidence of Decompensated Cirrhosis|A patient will be characterized as having decompensated cirrhosis from an encounter indicating jaundice (ICD-9 diagnosis code of 782.4 or ICD-10 code of R17), ascites (ICD-9 diagnosis code of 789.5, 789.51, 789.59 or ICD-10 diagnosis code of R18.0, R18.8, K71.51, K70.11, or K70.31), or varices (ICD-9 diagnosis code of 456.0, 456.20 or ICD-10 diagnosis code of I85.01 or I85.11, or a medication dispense of lactulose or rifaximin along with a diagnosis of cirrhosis.|Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.|The analysis population consists of the subset of patients without prior diagnosis of jaundice, ascites, hemorrhagic varices or medication dispense of lactulose or rifaximin.|||Events per 1000 person years||95% Confidence Interval|Number
2529837|NCT03423641|Primary|Incidence of Hemorrhagic Stroke|Inpatient encounters with ICD-9 diagnosis code of 430.xx-432.xx or ICD-10 code of I60.xx-I62.xx|Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.|The analysis population consists of the subset of patients without a prior diagnosis of a stroke.|||Events per 1000 person years||95% Confidence Interval|Number
2529838|NCT03423641|Primary|Incidence of Ischemic Stroke|Inpatient encounters with ICD-9 diagnosis code of 433.xx, 434.xx or ICD-10 code of I63.xx, I65.xx.|Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.|The analysis population consists of the subset of patients without a prior diagnosis of a stroke.|||Events per 1000 person years||95% Confidence Interval|Number
2529839|NCT03423641|Primary|Death|Date of death in one or more records. Death data comes from medical records, Social Security, or state databases.|Death dates will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.|The analysis population is equivalent to the baseline population.|||Events per 1000 person years||95% Confidence Interval|Number
2529840|NCT03423641|Primary|Incidence of Multiple Organ Dysfunction Syndrome (MODS)|Inpatient encounters with ICD-9 diagnosis code of 995.92, 995.94, 785.52 or ICD-10 code of R65.11 or R65.2x.|Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.|The analysis population consists of the subset of patients without a prior diagnosis of MODS.|||Events per 1000 person years||95% Confidence Interval|Number
2529841|NCT03423641|Primary|Incidence of Acute Kidney Failure (AKF)|Encounters with an ICD-9 diagnosis code of 584.xx or ICD-10 diagnosis code of N17.xx.|Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.|The analysis population consists of the subset of patients without a prior diagnosis of AKF.|||Events per 1000 person years||95% Confidence Interval|Number
2529842|NCT03423641|Primary|Incidence of Acute on Chronic Liver Failure|An acute change in MELD (model for end stage liver disease) score of 5 or more and the change is deemed to have persisted (defined as meeting one of the following criteria: MELD continues to be elevated 3 months later, liver transplant, death). The minimum value for the MELD is 6.43, but there is no maximum value. Higher scores mean a worse outcome.|Labs and diagnoses collected from clinical encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.|The analysis population consists of the subset of patients with MELD scores less than 15 at baseline.|||Events per 1000 person years||95% Confidence Interval|Number
2529843|NCT03423641|Primary|Incidence of Acute Myocardial Infarction (AMI)|Inpatient encounter with an ICD-9 diagnosis code of 410.xx or ICD-10 diagnosis code of I21.xx.|Patient diagnoses collected from encounters will be examined through study completion, or up to 180 days from the day the patient initiated a DAA.|The analysis population consists of the subset of patients without a prior diagnosis of MI.|||Events per 1000 person years||95% Confidence Interval|Number
2529844|NCT03421730|Secondary|Use of Concomitant Medications|Number of subjects using concomitant medications.|Visit 1||||Participants|||Count of Participants
2529845|NCT03421730|Secondary|Changes in Physical Examination|Physical examination data were listed. The number of participants with a change in physical examination status (i.e. from normal to abnormal, or from abnormal to normal) is presented below.|Visit 1, and Day 8 of Visit 3.||||Participants|||Count of Participants
2529846|NCT03421730|Secondary|Changes in Vital Signs (Temperature)|Mean values for temperature from pre-dose to 0.5 hours post-dose.|Baseline to Day 1 0.5 hours post-dose||||Change in degrees Celsius||Standard Deviation|Mean
2529847|NCT03421730|Secondary|Changes in Vital Signs (Respiration Rate)|Mean values for respiratory rate from pre-dose to 0.5 hours post-dose.|Baseline to Day 1 0.5 hours post-dose||||Change in breaths per minute||Standard Deviation|Mean
2529848|NCT03421730|Secondary|Changes in Vital Signs (Heart Rate)|Mean values for heart rate from pre-dose to 0.5 hours post-dose.|Baseline to Day 1 0.5 hours post-dose||||change in beats per minute||Standard Deviation|Mean
2554592|NCT02756689|Secondary|Highest Maternal Intrapartum Temperature||Assessed from baseline to delivery, up to 3 days||||Celsius||Standard Deviation|Mean
2529850|NCT03421730|Secondary|Mean Modified PASAPQ Score Indicating Willingness to Continue With the Device (Q10).|The PASAPQ is a validated multi-item measure of satisfaction and preference with inhaler devices. The modified PASAPQ consists of 10 questions. Question 10 asks about willingness to continue with the device(s) used in the trial. Parents/legal guardians were asked to indicate how willing they would be for their child to use the nebulizer used during the study, providing a number between 0 (unwilling) and 100 (willing).|Following dosing on Day 1 (Visit 2) and Day 8 (Visit 3).|Safety set included 15 (88%) subjects who received at least one dose of study treatment.|||scores on a scale||Standard Deviation|Mean
2529851|NCT03421730|Secondary|Mean Modified PASAPQ Satisfaction Score (Q9).|The PASAPQ is a validated multi-item measure of satisfaction and preference with inhaler devices. The modified PASAPQ consists of 10 questions. Question 9 asks for overall satisfaction with the device(s) used in the trial. Question 9 was answered using scores from 1 (i.e., very dissatisfied) to 7 (i.e., very satisfied).|Following dosing on Day 1 (Visit 2) and Day 8 (Visit 3).|Safety set included 15 (88%) subjects who received at least one dose of study treatment.|||scores on a scale||Standard Deviation|Mean
2529852|NCT03421730|Secondary|Mean Modified PASAPQ Performance Score|The PASAPQ is a validated multi-item measure of satisfaction and preference with inhaler devices; it was originally a 15-item questionnaire, with performance assessed over 7 items. The modified PASAPQ (mPASAPQ) has 10 questions, including only 4 from the performance domain; the 3 questions not included were dropped from the mPASAPQ as they were not applicable to patient population and device under study. Questions 1, 2, 6, and 7 were assessed, covering satisfaction with nebulizer reliability, ease of inhalation, use and treatment time. Although specified in the protocol, the mPASAPQ performance score was not summarized in the efficacy analysis. The results for each question are presented below, however it was not considered appropriate to analyze the performance domain, as it is not possible to verify the validity of the questionnaire utilising only 4 of the original 7 questions. Questions were answered using scores from 1 (i.e., very dissatisfied) to 7 (i.e., very satisfied).|Following dosing on Day 1 (Visit 2) and Day 8 (Visit 3).|Although specified in the protocol, mPASAPQ performance score wasn't summarized in the efficacy analysis as 3 questions were dropped from the PASAPQ that were not applicable. This change from the protocol-planned analysis was described in the SAP, finalized before DB lock. Individual scores for the 4 remaining performance questions are presented.|||scores on a scale||Standard Deviation|Mean
2529853|NCT03421730|Secondary|Mean Modified Patient Satisfaction and Preference Questionnaire (PASAPQ) Total Score (Q1 to Q8).|The PASAPQ is a validated multi-item measure of satisfaction and preference with inhaler devices. The modified PASAPQ consists of 10 questions. The first 8 questions generate the total score domain. Data from this questionnaire were listed by subject and summarized by treatment. The results from Questions 1 through 8 were added for each subject to generate the Total Score (n = Q1+Q2+Q3+Q4+Q5+Q6+Q7+Q8) and expressed as percentage of maximum total score (i.e., (n/56)*100). Questions 1 to 8 were answered using scores from 1 (i.e., very dissatisfied) to 7 (i.e., very satisfied).|Following dosing on Day 1 (Visit 2) and Day 8 (Visit 3).|Safety set included 15 (88%) subjects who received at least one dose of study treatment.|||percentage of maximum total score||Standard Deviation|Mean
2529854|NCT03421730|Primary|T1/2 of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer).|T1/2 is the apparent first-order terminal elimination half-life.|Pre-dose, and at 20 minutes, 40 minutes, 1.5, 3, 4, 6 and 8 hours after start of nebulization on Day 1 (Visit 2) and Day 8 (Visit 3).|Pharmacokinetic set included 13 (76%) subjects.|||hours||Standard Deviation|Mean
2529855|NCT03421730|Primary|Tlast of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer).|Tlast is the time of the last measurable concentration (Clast).|Pre-dose, and at 20 minutes, 40 minutes, 1.5, 3, 4, 6 and 8 hours after start of nebulization on Day 1 (Visit 2) and Day 8 (Visit 3).|Pharmacokinetic set included 13 (76%) subjects.|||hours||Standard Deviation|Mean
2529856|NCT03421730|Primary|Tmax of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer).|Tmax is the time to reach Cmax.|Pre-dose, and at 20 minutes, 40 minutes, 1.5, 3, 4, 6 and 8 hours after start of nebulization on Day 1 (Visit 2) and Day 8 (Visit 3).|Pharmacokinetic set included 13 (76%) subjects.|||hours||Full Range|Median
2529857|NCT03421730|Primary|Cmax of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer).|Cmax is the maximum observed concentration.|Pre-dose, and at 20 minutes, 40 minutes, 1.5, 3, 4, 6 and 8 hours after start of nebulization on Day 1 (Visit 2) and Day 8 (Visit 3).|Pharmacokinetic set included 13 (76%) subjects.|||pg/mL||Standard Deviation|Mean
2529858|NCT03421730|Primary|AUCinf of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer).|AUCinf is the area under the plasma concentration-time curve, from time 0 extrapolated to infinity. AUCinf is calculated as the sum of AUClast plus the ratio of the last measurable plasma concentration (Clast) to the elimination rate constant (λz).|Pre-dose, and at 20 minutes, 40 minutes, 1.5, 3, 4, 6 and 8 hours after start of nebulization on Day 1 (Visit 2) and Day 8 (Visit 3).|Pharmacokinetic set included 13 (76%) subjects.|||pg*hr/mL||Standard Deviation|Mean
2529859|NCT03421730|Primary|AUClast of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer).|AUClast is the area under the plasma concentration-time curve, from time 0 to the time of the last measurable concentration (Clast).|Pre-dose, and at 20 minutes, 40 minutes, 1.5, 3, 4, 6 and 8 hours after start of nebulization on Day 1 (Visit 2) and Day 8 (Visit 3).|Pharmacokinetic set included 13 (76%) subjects.|||pg*hr/mL||Standard Deviation|Mean
2529860|NCT03421379|Secondary|PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM|PK assessment measured the change from baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM.|Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||hour (h)||Full Range|Median
2529911|NCT03418064|Primary|Post-blink Movement|Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)|Dispense||||score on a scale||Standard Deviation|Mean
2529861|NCT03421379|Secondary|PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM|PK assessment measured the change from baseline in maximal concentration (Cmax) of glucagon nasal powder and glucagon hydrochloride IM.|Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||picogram/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2529862|NCT03421379|Secondary|Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM|PK assessment measured the change from baseline in the area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of Glucagon Nasal Powder and Glucagon Hydrochloride IM.|Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||Picogram*hour/milliliter (pg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2529863|NCT03421379|Secondary|PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM|PD assessment measured the time to maximal concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM.|Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration|All randomized participants who received at least one dose of study drug and had evaluable PD data.|||hour||Full Range|Median
2529864|NCT03421379|Secondary|Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)|PD assessment measured the change from Baseline in maximal blood glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride intramuscular (IM).|Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration|All randomized patients who receive at least 1 dose of the study drug and have evaluable PD data.|||milligram/deciliter (mg/dL)||Geometric Coefficient of Variation|Geometric Mean
2529865|NCT03421379|Primary|Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia|Percentage of participants who achieved treatment success during the controlled insulin-induced hypoglycemia in participants with type 1 diabetes mellitus (T1DM) and participants with type 2 diabetes mellitus (T2DM).Treatment success is defined as an increase in plasma glucose to greater than or equal to (≥) 70 milligrams per deciliter (mg/dL) or an increase of ≥20 mg/dL from plasma glucose nadir, without receiving additional actions to increase the plasma glucose concentration. Nadir is defined as the minimum plasma glucose concentration at the time of or within 10 minutes following glucagon administration.|Pre-dose up to 30 minutes post each glucagon administration|All randomized participant who completed both treatment visits and had evaluable treatment success data.|||percentage of participants|||Number
2529866|NCT03420625|Secondary|Tolerability to IPC and NMES According to Visual Analogue Scale 0-10|All subjects will be asked to subjectively grade each modality according to how comfortable or uncomfortable it felt under the time was applied to the subject according to Visual Analogue Scale 0-10. The following description will be given to the subjects: 0 denotes the the modality was totally intolerable, 10 denotes that the modality is very pleasant to use and 5 denotes neither pleasant nor unpleasant feeling.|one minute|"The interventions were performed sequentially on each participant as listed after baseline, in total 10 participants.~One patient did not perform the Rapid calf IPC intervention"|||units on a scale||Standard Deviation|Mean
2529867|NCT03420625|Primary|Blood Flow - Ejected Volume Per Individual Stimulus (ml)|With the use of Doppler Ultrasound Ejected volume per individual stimulus (ml) is assessed in the popliteal vein.|up to one hour in total||||ml||Standard Deviation|Mean
2529868|NCT03420625|Primary|Blood Flow - Volume Flow (ml/Min)|With the use of Doppler Ultrasound Volume flow (ml/min), is assessed in the popliteal vein.|up to one hour in total||||ml/min||Standard Deviation|Median
2529869|NCT03420625|Primary|Blood Flow - Time-averaged Mean Velocity (cm/Sec)|With the use of Doppler Ultrasound Time-averaged mean velocity (cm/sec) is assessed in the popliteal vein.|up to one hour in total||||cm/s||Standard Deviation|Mean
2529870|NCT03420625|Primary|Blood Flow - Peak Systolic Velocity (cm/Sec)|With the use of Doppler Ultrasound Peak systolic velocity (cm/sec) is assessed in the popliteal vein.|up to one hour in total|"The interventions were performed sequentially on each participant as listed after baseline, in total 10 participants.~One patient did not perform the Rapid calf IPC intervention"|||cm/s||Standard Deviation|Mean
2529871|NCT03420300|Secondary|Week 12 Virologic Response (W12VR)|Proportion of patients who completed 12 weeks of elbasvir/grazoprevir (EBR/GZR) treatment and who had undetectable serum HCV RNA at week 12 of treatment|12 weeks||||Participants|||Count of Participants
2529872|NCT03420300|Secondary|End-of-treatment Virological Response (EOTVR) Rate|Proportion of patients who had undetectable serum HCV RNA at the time point of treatment completion for elbasvir/grazoprevir (EBR/GZR)|12 weeks||||Participants|||Count of Participants
2529873|NCT03420300|Secondary|Rapid Virologic Response (RVR) Rate|Proportion of patients who had undetectable serum HCV RNA at week 4 of elbasvir/grazoprevir (EBR/GZR) treatment|4 weeks||||Participants|||Count of Participants
2529874|NCT03420300|Secondary|Sustained Virologic Response (SVR24) Rate|Proportion of patients who had undetectable serum HCV RNA 24 weeks after the completion of elbasvir/grazoprevir (EBR/GZR)|36 weeks||||Participants|||Count of Participants
2529875|NCT03420300|Secondary|Treatment-emergent Adverse Event (AE)-Related Withdrawal Rate|Proportion of participants who withdrew from the study due to any adverse events (AEs) which were judged related to elbasvir/grazoprevir (EBR/GZR)|12 weeks||||Participants|||Count of Participants
2529876|NCT03420300|Primary|Sustained Virologic Response (SVR12) Rate|Proportion of patients who had undetectable serum HCV RNA 12 weeks after the completion of elbasvir/grazoprevir (EBR/GZR)|24 weeks||||Participants|||Count of Participants
2529877|NCT03419962|Secondary|Patient's Willingness to Continue Treatment With Spiolto® Respimat® at Visit 2|Patients' reported willingness to continue using either of the inhalers was measured with a scale score ranking from 0 to 100. 0 indicates not willing to continue using this inhaler and 100 indicates definitely willing to continue using it.|At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit).|Only patients from the Full Analysis Set (FAS), who have used Spiriva HandiHaler (HH) prior to the study. Only 253 patients were analyzed, as one patient did not answer the question.|||Scores on scale||Standard Deviation|Mean
2529878|NCT03419962|Secondary|Patients Preference for Spiolto® Respimat® at Visit 2|Patients preference for Respimat® Inhaler vs. Spiriva HandiHaler (HH) was assessed using the abbreviated Patient Satisfaction and Preference Questionnaire (PASAPQ) Part 2 survey. Patients were requested to describe their preference for each inhaler device by answering 2 additional questions.|At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit)|Only patients from the Full Analysis Set (FAS), who have used Spiriva HandiHaler (HH) prior to the study.|||Participants|||Count of Participants
2529879|NCT03419962|Secondary|Patients Satisfaction With Spiolto® Respimat® at Visit 2|The patients satisfaction with Respimat was assessed at end of study (visit 2) by the Patient Satisfaction and Preference Questionnaire (PASAPQ) Part 1. PASAPQ Part 1 uses a 7-point ordinal scale, ranging from very dissatisfied to very satisfied, to rate the satisfaction with inhaler attributes. The patients were requested to describe their satisfaction level answering three questions.|At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit).|Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both visit 1 and visit 2. Only 1330 patients completed the PASAPQ Part1+Part2.|||Participants|||Count of Participants
2529880|NCT03419962|Secondary|General Condition of Patient at Visit 1 and Visit 2|"General condition of the patient, evaluated by Physician´s Global Evaluation (PGE) score at visit 1 and visit 2.~The PGE score uses a eight-point ordinal scale, ranging from poor (1,2) to excellent (7,8)."|At visit 1 (baseline visit at study start) and at visit 2 (final visit at the end of study, approximately 6 weeks after visit 1).|Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both visit 1 and visit 2.|||Participants|||Count of Participants
2529881|NCT03419962|Secondary|Absolute Change in the Functional Status Subdomain of Clinical COPD Questionnaire (CCQ-4) Score Between Visit 1 and Visit 2|"Absolute change in the functional status subdomain of Clinical COPD Questionnaire (CCQ-4) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1).~The CCQ-4 score is a subdomain of the CCQ-score. It contains 4 questions about the functional status of patients. Each questions was scored by the patient on a 7-point scale, (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The QQC-4 score was calculated by the sum of 4 questions divided by 4. A higher CCQ-4 score was indicative of worse status."|At visit 1 (baseline visit at study start) and at visit 2 (final visit at the end of study, approximately 6 weeks after visit 1).|Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both visit 1 and visit 2.|||CCQ-4 score||Standard Deviation|Mean
2529882|NCT03419962|Secondary|Absolute Change in Clinical COPD Questionnaire (CCQ) Score Between Visit 1 and Visit 2|"Absolute change in Clinical COPD Questionaire (QQC) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1).~The CCQ contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6. The sum of the scores divided by 10 gives the CCQ score which measured the health and functional status. A higher CCQ score is indicative of worse status."|At visit 1 (baseline visit at study start) and at visit 2 (final visit at end of study, approximately 6 weeks after visit 1).|Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both visit 1 and visit 2.|||CCQ-score||Standard Deviation|Mean
2529883|NCT03419962|Primary|"Percentage of Patients Achieving Therapeutic Success Defined as a ≥ 0.4 Point of Decrease in the Clinical COPD Questionnaire (CCQ) Score"|"Therapeutic success was defined as ≥0.4 point decrease in the Clinical COPD Questionnaire (CCQ) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1).~The CCQ contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The sum of the scores divided by 10 gives the CCQ score. A higher CCQ score is indicative of worse status. A decrease of 0.4 points is considered to be the minimal clinically important difference (MCID) for CCQ score."|Between visit 1 (baseline visit at study start) and visit 2 (final visit after end of study, approximately 6 weeks after visit 1).|Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both visit 1 and visit 2.|||Percentage of participants||95% Confidence Interval|Number
2529884|NCT03419078|Secondary|5 Year Survival||5 years after the date of hematopoietic cell infusion||||percentage of participants||95% Confidence Interval|Mean
2529885|NCT03419078|Secondary|Graft Versus Host Disease-free and Relapse-free Survival|GvHD-free/relapse-free survival (GRFS). Events in GRFS included grade 3-4 acute GvHD, systemic therapy-requiring chronic GvHD, relapse, or death|5 years after the date of hematopoietic cell infusion||||percentage of participants||95% Confidence Interval|Mean
2529886|NCT03419078|Primary|Non Relapse Mortality|Defined as death without previous relapse|100 days after the date of hematopoietic cell infusion||||percentage of participants||95% Confidence Interval|Mean
2529887|NCT03419078|Primary|Number of Participants With Acute Graft Versus Host Disease (GvHD) at Any Site (Grade II or Above) and Acute GvHD of the Gut of Any Grade|Occurrence of acute GvHD at any site (grade II or above) and acute GvHD of the gut of any grade (graded according to standard criteria). Standard criteria to grade the severity of acute GvHD are quantification of rash, serum bilirubin and diarrhoea. These standard criteria have been developed and used for > 20 years by most transplant centres to improve comparability between publications.|100 days after the date of hematopoietic cell infusion|There were 439 and 438 evaluable cases respectively for acute GvHD grade II or greater and gastrointestinal acute GvHD of any grade after exclusion of patients that died before day 100 without acute GvHD.|||Participants|||Count of Participants
2529888|NCT03418662|Secondary|Problems Encountered With Equipment|Occurrences of slippage of EndoRings or of device being removed on insertion.|During colonoscopy procedure|This outcome measure is not applicable for patients randomized to the standard arm because there is no device attached in the standard arm of the study. For this reason, 0 patients are reported for the standard arm for this specific outcome measure.|||Participants|||Count of Participants
2529889|NCT03418662|Secondary|Patient Comfort Score|Comparison of patient comfort between Standard colonoscopy and EndoRings colonoscopy on a scale of 0 to 10 with 0 being no pain (best outcome) and 10 being worst imaginable pain (worst outcome).|After colonoscopy was completed while patient was in recovery area of endoscopy unit||||units on a scale||Standard Deviation|Mean
2529890|NCT03418662|Secondary|Time Comparison for Each Method|"Comparison of the time required to reach the cecum, withdrawal time, and total procedure time.~Insertion time: time required to reach the cecum Withdrawal time: time calculated from when withdrawing is started in the cecum till the colonoscope is removed. This includes time spent washing, inspecting the colon and removing polyps.~Total procedure time: This is the sum of insertion and withdrawal times along with any time spent washing or removing polyps while in the cecum (before starting withdrawal)."|During colonoscopy procedure||||Minutes||Standard Deviation|Mean
2529891|NCT03418662|Secondary|Cecal Intubation Rate|Comparison of cecal intubation rate (the number of procedures where the colonoscope was able to be inserted all the way to the cecum) between standard colonoscopy and EndoRings colonoscopy.|During colonoscopy procedure||||Participants|||Count of Participants
2529892|NCT03418662|Secondary|Total Number of Detections|Comparison of the total number of polyps detected and the total number of adenomas detected between EndoRings colonoscopy and Standard colonoscopy.|During colonoscopy procedure||||Detections|||Number
2529893|NCT03418662|Secondary|Number of Detections Per Colonoscopy|Comparison of the number of polyps detected per colonoscopy between EndoRings colonoscopy and Standard colonoscopy.|During colonoscopy procedure||||polyps per colonoscopy||Standard Deviation|Mean
2529894|NCT03418662|Secondary|Polyp Detection Rate|Number of subjects with at least one polyp detected with Standard Colonoscopy compared to colonoscopy with EndoRings.|During colonoscopy procedure||||Participants|||Count of Participants
2529895|NCT03418662|Primary|Number of Adenomas Per Colonoscopy|Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy.|During colonoscopy procedure||||adenomas per colonoscopy||Standard Deviation|Mean
2529896|NCT03418662|Primary|Adenoma Detection Rates|Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings.|During colonoscopy procedure||||Participants|||Count of Participants
2529897|NCT03418571|Primary|Safety and Tolerability of Inhaled ALX-0171 1.5 mg/kg as Measured by the Number of Serious and Non-serious TEAEs.|Number of serious and non-serious TEAEs reported in the ALX-0171 1.5 mg/kg treatment group and placebo treatment group.|From the subject's first study drug administration until completion of the subject's last visit, an average of 4 weeks|Safety Population|||TEAE|||Number
2529898|NCT03418571|Primary|Safety and Tolerability of Inhaled ALX-0171 1.5 mg/kg as Measured by the Number of Subjects With at Least 1 Serious or Non-Serious Treatment-emergent Adverse Event (TEAE).|Number of subjects reported with at least 1 serious or non-serious TEAEs in the ALX-0171 1.5 mg/kg treatment group and placebo treatment group.|From the subject's first study drug administration until completion of the subject's last visit, an average of 4 weeks|Safety Population|||participants|||Number
2529899|NCT03418376|Primary|Workload|Exercise capacity will be assessed using a maximal (12-lead ECG) graded cardiopulmonary exercise test (♂: 30W+15W/min, ♀: 20W+10W/min, GE eBike Basic®) with pulmonary gas exchange analysis (Jaeger Oxycon®). VO2max (maximal oxygen uptake) will be monitored. This test will be performed at least 48 hours separated from the muscle strength test, to prevent interference of muscle fatigue. Respiratory exchange ratio (RER) values will be evaluated to verify if the test was performed maximally (RER >1.1).|Before and after 6 months training (pre vs post)||||Wattage||Standard Deviation|Mean
2529900|NCT03418376|Primary|Strength Assessment Core Musculature|Back- and abdominal muscle strength will be assessed using an isokinetic dynamometer (System 3, Biodex, ENRAF-NONIUS, New York, USA). After adequate warming-up and movement familiarization, subjects will perform 3 maximal isometric contractions of back- and abdominal muscles for 4-5sec. The peak value of the 3 maximal contractions will be reported (peak back, and peak abdominal muscles).|Before and after 6 months training (pre vs post)||||Nm||Standard Deviation|Mean
2529901|NCT03418376|Primary|Body Composition|Whole body fat and lean tissue mass will be obtained using Dual Energy X-ray Absorptiometry scan (DEXA) (Hologic Series Delphi-A Fan Beam X-ray Bone Densitometer, Vilvoorde, Belgium). A calibrated analogue weight balance (Seca®) will be used to measure total body mass.|Before and after 6 months training (pre vs post)||||kg||Standard Deviation|Mean
2529902|NCT03418376|Primary|Serum Lactate|During the exercise test, 2min capillary blood samples will be obtained to analyse blood lactate concentrations (Analox®) and determine the anaerobic threshold before, during and after exercise. Lactate max levels are the maximal concentrations measured during the test, whilst peak Lactate are the lactate concentrations following 2 minutes of rest after cessation of the maximal exercise test.|Before and after 6 months training (pre vs post)||||mmol/L||Standard Deviation|Mean
2529903|NCT03418376|Primary|VO2max|Exercise capacity will be assessed using a maximal (12-lead ECG) graded cardiopulmonary exercise test (♂: 30W+15W/min, ♀: 20W+10W/min, GE eBike Basic®) with pulmonary gas exchange analysis (Jaeger Oxycon®). VO2max (maximal oxygen uptake) will be monitored. This test will be performed at least 48 hours separated from the muscle strength test, to prevent interference of muscle fatigue. Respiratory exchange ratio (RER) values will be evaluated to verify if the test was performed maximally (RER >1.1).|Before and after 6 months training (pre vs post)||||ml/kg/min||Standard Deviation|Mean
2529904|NCT03418064|Secondary|Average Comfortable Wearing Time|Typical time of day when subject first experiences lens awareness or irritation|1 Month||||hours per day||Standard Deviation|Mean
2529905|NCT03418064|Secondary|Average Comfortable Wearing Time|Typical time of day when subject first experiences lens awareness or irritation.|Baseline||||hours per day||Standard Deviation|Mean
2529906|NCT03418064|Secondary|Average Hours of Wear Per Day|Number of hours lenses are worn per day|1 month||||hours per day||Standard Deviation|Mean
2529907|NCT03418064|Secondary|Average Hours of Wear Per Day|Number of hours lenses are worn per day|Baseline||||hours per day||Standard Deviation|Mean
2529908|NCT03418064|Primary|Overall Fit Acceptance|Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)|1 Month||||units on a scale||Standard Deviation|Mean
2529909|NCT03418064|Primary|Overall Fit Acceptance|Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect)|Dispense||||units on a scale||Standard Deviation|Mean
2529910|NCT03418064|Primary|Post-blink Movement|Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement)|1 Month||||score on a scale||Standard Deviation|Mean
2529919|NCT03417830|Secondary|Part B: Number of Participants With Abnormal Urinalysis Parameters: Specific Gravity, Potential of Hydrogen|Urine samples were planned to be collected to analyze the urinalysis parameters.|Up to Day 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529920|NCT03417830|Secondary|Part B: Number of Participants With Abnormal Urinalysis Parameters: Glucose, Protein, Blood, Ketones|Urine samples were planned to be collected to analyze the urinalysis parameters.|Up to Day 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529921|NCT03417830|Secondary|Part A: Number of Participants With Abnormal Urinalysis Parameters: Specific Gravity, Potential of Hydrogen|Urine samples were collected to analyze urinalysis parameters including specific gravity and potential of hydrogen.|Up to Day 26 of the last session|Safety Population.|||Participants|||Count of Participants
2529922|NCT03417830|Secondary|Part A: Number of Participants With Abnormal Urinalysis Parameters: Glucose, Protein, Blood, Ketones|Urine samples were collected to analyze urinalysis parameters including glucose, protein, blood and ketones.|Up to Day 26 of the last session|Safety Population.|||Participants|||Count of Participants
2529923|NCT03417830|Secondary|Part B: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Bilirubin, Creatinine|Blood samples were planned to be collected to analyze the chemistry parameters.|Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529924|NCT03417830|Secondary|Part A: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Bilirubin, Creatinine|Blood samples were collected to analyze the chemistry parameters: Direct Bilirubin, Bilirubin, Creatinine. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2529925|NCT03417830|Secondary|Part B: Change From Baseline in Chemistry Parameters: ALP, ALT, AST|Blood samples were planned to be collected to analyze the chemistry parameters.|Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529926|NCT03417830|Secondary|Part A: Change From Baseline in Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST)|Blood samples were collected to analyze the chemistry parameters: ALP, ALT and AST. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||International units per liter||Standard Deviation|Mean
2529927|NCT03417830|Secondary|Part B: Change From Baseline in Chemistry Parameters: Albumin, Protein|Blood samples were planned to be collected to analyze the chemistry parameters.|Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529928|NCT03417830|Secondary|Part A: Change From Baseline in Chemistry Parameters: Albumin, Protein|Blood samples were collected to analyze the chemistry parameters: Albumin and Protein. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2529929|NCT03417830|Secondary|Part B: Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea|Blood samples were planned to be collected to analyze the chemistry parameters.|Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529930|NCT03417830|Secondary|Part A: Change From Baseline in Chemistry Parameters: Glucose, Calcium, Potassium, Sodium, Urea|Blood samples were collected to analyze the chemistry parameters: Glucose, Calcium, Potassium, Sodium and Urea. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2529931|NCT03417830|Secondary|Part B: Change From Baseline in Hematology Parameters: Erythrocytes, Reticulocytes|Blood samples were planned to be collected to analyze the hematology parameters.|Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529932|NCT03417830|Secondary|Part A: Change From Baseline in Hematology Parameters: Erythrocytes, Reticulocytes|Blood samples were collected to analyze the hematology parameters: Erythrocytes and Reticulocytes. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||10^12 cells per liter||Standard Deviation|Mean
2529933|NCT03417830|Secondary|Part B: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume|Blood samples were planned to be collected to analyze the hematology parameter.|Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2546645|NCT02918552|Other Pre-specified|Blood Nitrate|Change in blood levels to assess efficacy of study drug|Week 5 (pre drug) to week 16 (post drug); approx. 8 week|||||||
2529934|NCT03417830|Secondary|Part A: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume|Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Femtoliter||Standard Deviation|Mean
2529935|NCT03417830|Secondary|Part B: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin|Blood samples were planned to be collected to analyze the hematology parameter.|Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529936|NCT03417830|Secondary|Part A: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin|Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Picograms||Standard Deviation|Mean
2529937|NCT03417830|Secondary|Part B: Change From Baseline in Hematology Parameter: Hemoglobin|Blood samples were planned to be collected to analyze the hematology parameter.|Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529938|NCT03417830|Secondary|Part A: Change From Baseline in Hematology Parameter: Hemoglobin|Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1- Pre-dose, Days 3, 5, 7, 10 and 26|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2529939|NCT03417830|Secondary|Part B: Change From Baseline in Hematology Parameter: Hematocrit|Blood samples were planned to be collected to analyze the hematology parameter.|Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529940|NCT03417830|Secondary|Part A: Change From Baseline in Hematology Parameter: Hematocrit|Blood samples were collected to analyze the hematology parameter: Hematocrit. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1-Pre-dose, Days 3, 5, 7, 10 and 26|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Percentage of red blood cells in blood||Standard Deviation|Mean
2529941|NCT03417830|Secondary|Part B: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets|Blood samples were planned to be collected to analyze the hematology parameters.|Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529942|NCT03417830|Secondary|Part A: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets|Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Session 1: Baseline (Day 1 Pre-dose), Days 3, 5, 7, 10 and 26; Session 2: Day 1-Pre-dose, Days 3, 5, 7, 10 and 26|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Billion cells per liter||Standard Deviation|Mean
2529943|NCT03417830|Secondary|Part B: Number of Participants With New Abnormal Physical Examination Findings|A full and brief physical examination was planned to be performed, including assessments of the skin, lungs, cardiovascular system and abdomen (liver and spleen).|At screening (within 35 days of Anti-SAP treatment), Days 1, 3, 5, 8 and 11|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529944|NCT03417830|Secondary|Part A: Number of Participants With New Abnormal Physical Examination Findings|A full and brief physical examination was performed, including assessments of the skin, lungs, cardiovascular system and abdomen (liver and spleen).|Session 1: At screening (within 35 days of Anti-SAP treatment of session 1), Day 1 Pre-dose, Day 3, Day 5, Day 8 and Day 11; Session 2: Day 1 Pre-dose, Day 3, Day 5, Day 8 and Day 11|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2529945|NCT03417830|Secondary|Part B: Number of Participants With Abnormal Pulse Rate|Pulse rate was planned to be measured in a semi-supine position after 5 minutes of rest for the participant.|Up to Day 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529946|NCT03417830|Secondary|Part A: Number of Participants With Abnormal Pulse Rate|Pulse rate were measured in a semi-supine position after 5 minutes of rest for the participant. PCI range for the pulse rate was as follows: pulse rate- <35 and >140 beats per minute (bpm).|Up to Day 26 of the last session|Safety Population.|||Participants|||Count of Participants
2529947|NCT03417830|Secondary|Part B: Number of Participants With Abnormal Respiratory Rate|Respiratory rate was planned to be measured in a semi-supine position after 5 minutes of rest for the participant.|Up to Day 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529948|NCT03417830|Secondary|Part A: Number of Participants With Abnormal Respiratory Rate|Respiratory rate was measured in a semi-supine position after 5 minutes of rest for the participant. Normal range for the respiratory rate was as follows: respiratory rate- <12 and >25 breaths per minute.|Up to Day 26 of the last session|Safety Population.|||Participants|||Count of Participants
2529949|NCT03417830|Secondary|Part B: Number of Participants With Abnormal Temperature|Temperature was planned to be measured in a semi-supine position after 5 minutes of rest for the participant.|Up to Day 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529950|NCT03417830|Secondary|Part A: Number of Participants With Abnormal Temperature|Temperature was measured in a semi-supine position after 5 minutes of rest for the participant. Normal range for temperature was as follows: temperature- >37.5 degree celsius.|Up to Day 26 of the last session|Safety Population.|||Participants|||Count of Participants
2529951|NCT03417830|Secondary|Part B: Number of Participants With Abnormal SBP and DBP|SBP and DBP were planned to be measured in a semi-supine position after 5 minutes of rest for the participant.|Up to Day 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529952|NCT03417830|Secondary|Part A: Number of Participants With Abnormal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured in a semi-supine position after 5 minutes of rest for the participant. Potential Clinical Importance (PCI) ranges for the SBP and DBP were as follows: SBP- <90 and >180 millimeters of mercury (mmHg), and DBP- <30 and >110 mmHg.|Up to Day 26 of the last session|Safety Population.|||Participants|||Count of Participants
2529953|NCT03417830|Secondary|Part B: Number of Participants With Abnormal Outpatient Cardiac Telemetry|Continuous outpatient cardiac monitoring was planned to be performed via remote cardiac bodyguardian telemetry device.|Up to Day 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529954|NCT03417830|Secondary|Part A: Number of Participants With Abnormal Outpatient Cardiac Telemetry|Continuous outpatient cardiac monitoring was performed via remote cardiac bodyguardian telemetry device. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.|Up to Day 26 of the last session|Safety Population.|||Participants|||Count of Participants
2529955|NCT03417830|Secondary|Part B: Number of Participants With Abnormal Inpatient Cardiac Telemetry|Continuous inpatient cardiac monitoring was planned to be performed via remote cardiac telemetry device.|Up to Day 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529956|NCT03417830|Secondary|Part A: Number of Participants With Abnormal Inpatient Cardiac Telemetry|Continuous inpatient cardiac monitoring was performed via remote cardiac telemetry device. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.|Up to Day 26 of the last session|Safety Population.|||Participants|||Count of Participants
2529957|NCT03417830|Secondary|Part B: Number of Participants With Abnormal 12-lead ECG Findings|12-lead ECGs were planned to be measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant.|Up to Day 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529958|NCT03417830|Secondary|Part A: Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings|12-lead ECGs were measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.|Up to Day 26 of the last session|Safety Population.|||Participants|||Count of Participants
2529959|NCT03417830|Secondary|Part B: Change From Baseline in Cardiac Troponin T and NT-ProBNP|Blood samples were planned to be collected to analyze the troponin T and NT-ProBNP at indicated time points. Baseline was considered as the latest pre-dose assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline and up to Day 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529960|NCT03417830|Secondary|Part A: Change From Baseline in Cardiac Troponin T and N-terminal Prohormone of Brain Natriuretic Peptide (NT-ProBNP)|Blood samples were collected to analyze the troponin T and NT-ProBNP at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. GSK2315698 or anti-SAP mAb (labelled or unlabelled) (Day 1, Pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Session 1: Baseline (Day 1 Pre-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 26; Session 2: Day 1- Pre-dose, Days 2, 3, 4, 5, 6, 7, 8, 9, 10 and 26|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Nanograms per liter||Standard Deviation|Mean
2529961|NCT03417830|Secondary|Part B: Number of Participants With Infusion Related Reactions|Number of participants with any infusion related reactions were planned to be reported.|Up to Day 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529962|NCT03417830|Secondary|Part A: Number of Participants With Infusion Related Reactions|Number of participants with any infusion related reactions are presented.|Up to Day 26 of the last session|Safety Population.|||Participants|||Count of Participants
2529963|NCT03417830|Secondary|Part B: Number of Participants With Cardiac Adverse Events|The number of participants with any cardiovascular AEs i.e. any AE coded to the cardiovascular system organ class were planned to be reported.|Up to Day 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529964|NCT03417830|Secondary|Part A: Number of Participants With Cardiac Adverse Events|The number of participants with any cardiovascular AEs i.e. any AE coded to the cardiovascular system organ class are presented.|Up to Day 26 of the last session|Safety Population.|||Participants|||Count of Participants
2530706|NCT03379740|Primary|Time to Peak Plasma Nicotine Concentration [Tpeak]|To measure the time to peak plasma nicotine concentration [tpeak] from 60 minutes of ad libitum use.|From Day -1 (baseline) to Day 4||||minutes||Full Range|Median
2529965|NCT03417830|Secondary|Part B: Number of Participants With Skin Rashes|Rash was planned to be graded as Grade 1 to Grade 4 based on symptoms and BSA affected; Grade 1: <10% BSA and asymptomatic; Grade 2: 10-30% BSA and/or mild symptoms (pain, itch and burning); Grade 3: >30% BSA and/or moderate/severe symptoms (pain, itch and burning); and Grade 4: any rash with mucosal or systemic involvement (such as evidence of renal involvement).|Up to Day 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529966|NCT03417830|Secondary|Part A: Number of Participants With Skin Rashes|Rash was graded as Grade 1 to Grade 4 based on symptoms and body surface area (BSA) affected; Grade 1: <10 percent (%) BSA and asymptomatic; Grade 2: 10-30% BSA and/or mild symptoms (pain, itch and burning); Grade 3: >30% BSA and/or moderate/severe symptoms (pain, itch and burning); and Grade 4: any rash with mucosal or systemic involvement (such as evidence of renal involvement).|Up to Day 26 of the last session|Safety Population.|||Participants|||Count of Participants
2529967|NCT03417830|Secondary|Part B: Number of Participants With AEs and SAEs|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events which may require medical or surgical intervention.|Up to Day 26|Safety Population. Data was not collected as no participants were enrolled in Part B.||||||
2529968|NCT03417830|Secondary|Part A: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events which may require medical or surgical intervention. Safety Population consisted of all participants who received at least one dose of GSK2315698, GSK2398852 or 89Zr-GSK2398852.|Up to Day 26 of the last session|Safety Population.|||Participants|||Count of Participants
2529969|NCT03417830|Secondary|Part B: AUC(0 to Infinity) of 89Zr- GSK2398852 Radio-PK|Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.|Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6|PK Population. Data was not collected as no participants were enrolled in Part B.||||||
2529970|NCT03417830|Secondary|Part A: AUC(0 to Infinity) of 89Zr- GSK2398852 Radio-PK|Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.|Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours*Becquerel per gram||Full Range|Mean
2529971|NCT03417830|Secondary|Part B: AUC(0 to t) of 89Zr- GSK2398852 Radio-PK|Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.|Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6|PK Population. Data was not collected as no participants were enrolled in Part B.||||||
2529972|NCT03417830|Secondary|Part A: AUC(0 to t) of 89Zr- GSK2398852 Radio-PK|Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.|Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours*Becquerel per gram||Full Range|Mean
2529973|NCT03417830|Secondary|Part B: T1/2 of 89Zr- GSK2398852 Radio-PK|Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.|Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6|PK Population. Data was not collected as no participants were enrolled in Part B.||||||
2529974|NCT03417830|Secondary|Part A: T1/2 of 89Zr- GSK2398852 Radio-PK|Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.|Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours||Full Range|Mean
2529975|NCT03417830|Secondary|Part B: Tmax of 89Zr-GSK2398852 Radio-PK|Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.|Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6|PK Population. Data was not collected as no participants were enrolled in Part B.||||||
2529976|NCT03417830|Secondary|Part A: Tmax of 89Zr- GSK2398852 Radio-PK|Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.|Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours||Full Range|Mean
2530534|NCT03383627|Secondary|Determination of Serum Fructosamine|Using blood glucose information measured with continuous blood glucose monitoring device, probable level of serum fructosamine (µmol/L) will be measured for each participant and mean will be analyzed.|14 days||||µmol/L||Standard Deviation|Mean
2529977|NCT03417830|Secondary|Part B: Cmax of 89Zr-GSK2398852 Radio-PK|Blood samples were planned to be collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was planned to be measured by scintillation counter.|Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6|PK Population. Data was not collected as no participants were enrolled in Part B.||||||
2529978|NCT03417830|Secondary|Part A: Cmax of 89Zr-GSK2398852 PKs of Radioactivity (Radio-PK)|Blood samples were collected at indicated time points for measurement of radioactivity. Radioactivity reflected the total concentration of 89Zr-GSK2398852 and its radioactive metabolites. Plasma radioactive concentration was measured using scintillation counter.|Sessions 1 and 2: Day 3 (10 minutes, 60 minutes, 4 hours, 7 hours post-dose), Days 4, 5 and 6|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Becquerel per gram||Full Range|Mean
2529979|NCT03417830|Secondary|Part B: AUC(0 to Infinity) of Total mAb|Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.|Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8|PK Population. Data was not collected as no participants were enrolled in Part B.||||||
2529980|NCT03417830|Secondary|Part A: Area Under the Concentration Time Curve Till Time Infinity (AUC[0 to Infinity]) of Total mAb|Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).|Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours*nanogram per milliliter||Full Range|Mean
2529981|NCT03417830|Secondary|Part B: AUC(0 to t) of Total mAb|Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.|Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8|PK Population. Data was not collected as no participants were enrolled in Part B.||||||
2529982|NCT03417830|Secondary|Part A:Area Under the Concentration Time Curve Till Last Observation (AUC[0 to t]) of Total mAb|Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).|Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours*nanogram per milliliter||Full Range|Mean
2529983|NCT03417830|Secondary|Part B: T1/2 of Total mAb|Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.|Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8|PK Population. Data was not collected as no participants were enrolled in Part B.||||||
2529984|NCT03417830|Secondary|Part A: Terminal Half-life (T1/2) of Total mAb|Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).|Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours||Full Range|Mean
2529985|NCT03417830|Secondary|Part B: Clearance of Total mAb|Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.|Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8|PK Population. Data was not collected as no participants were enrolled in Part B.||||||
2529986|NCT03417830|Secondary|Part A: Clearance of Total mAb|Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).|Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Liters per hour||Full Range|Mean
2529987|NCT03417830|Secondary|Part B: Tmax of Total mAb|Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.|Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8|PK Population. Data was not collected as no participants were enrolled in Part B.||||||
2529988|NCT03417830|Secondary|Part A: Time Associated With Cmax (Tmax) of Total mAb|Blood samples were collected at indicated time points for PK analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852).|Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours||Full Range|Mean
2529989|NCT03417830|Secondary|Part B: Cmax of Total mAb|Blood samples were planned to be collected at indicated time points for PK analysis of total mAb.|Day 3 (pre-dose, end of infusion, 4 and 7 hours post-infusion), Days 4, 5, 6, 7 and 8|PK Population. Data was not collected as no participants were enrolled in Part B.||||||
2529990|NCT03417830|Secondary|Part A: Maximum Concentration in Plasma (Cmax) of Total mAb|Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of total mAb (unlabelled GSK2398852 and 89Zr-GSK2398852). PK Population consisted of all participants from the All Treated Population for whom a PK sample was obtained and analyzed.|Sessions 1 and 2: Day 3 (pre-dose, halfway infusion, end of infusion, 4 and 7 hours after end of infusion), Days 4, 5, 6 and 7|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Nanograms per milliliter||Full Range|Mean
2529991|NCT03417830|Secondary|Part B: Mean SUV of Total Radioactivity Uptake After an Anti-SAP mAb Dose Between 200 mg and <=500 mg|SUV of total radioactivity uptake for different organs/tissues was planned to be measured.|Days 3, 4 and 6|All treated Population. Data was not collected as no participants were enrolled in Part B.||||||
2529992|NCT03417830|Secondary|Part B: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb|SUV of total radioactivity uptake for different organs/tissues was planned to be measured.|Days 3, 4 and 6|All treated Population. Data was not collected as no participants were enrolled in Part B.||||||
2530535|NCT03383627|Secondary|Mean Serum Fructosamine Concentration|Serum fructosamine (µmol/L) collected at the end of participation.|14 Days||||µmol/L||Inter-Quartile Range|Mean
2529993|NCT03417830|Secondary|Part A- Session 2: Mean SUV of Total Radioactivity Uptake After Anti-SAP mAb Dose Between 200 mg and <=500 mg|SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as adrenal gland, aorta, bone marrow, kidney, liver, spleen, abdominal region, brain, lung, parotid gland, thigh, and thyroid gland- goitre. Mean SUV derived from PET images has been presented.|Session 2: Days 3, 4, and 5|All treated Population. Only those participants with data available at the specified data points were analyzed.|||Grams per milliliter||Standard Deviation|Mean
2529994|NCT03417830|Secondary|Part A- Session 1: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb: Testes|SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for testes. Mean SUV derived from PET images has been presented.|Session 1: Days 4, 5 and 8|All treated Population. Only those participants with data available at the specified time points were analyzed.|||Grams per milliliter||Standard Deviation|Mean
2529995|NCT03417830|Secondary|Part A- Session 1: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb: Thyroid Gland-goitre|SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for thyroid gland-goitre. Mean SUV derived from PET images has been presented.|Session 1: Days 4 and 6|All treated Population. Only those participants with data available at the specified time points were analyzed.|||Grams per milliliter||Standard Deviation|Mean
2529996|NCT03417830|Secondary|Part A- Session 1: Mean SUV of Total Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb|SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as adrenal gland, aorta, bone marrow, kidney, liver, spleen, abdominal region, brain, lung, parotid gland, and thigh. Mean SUV derived from PET images has been presented.|Session 1: Days 4, 5, 6 and 8|All treated Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Grams per milliliter||Standard Deviation|Mean
2529997|NCT03417830|Secondary|Part B: Mean SUV of Focal Radioactivity Uptake After Anti-SAP mAb Dose Between 200 mg and <=500 mg|SUV of focal radioactivity uptake for different organs/tissues was planned to be measured.|Days 3, 4 and 6|All treated Population. Data was not collected as no participants were enrolled in Part B.||||||
2529998|NCT03417830|Secondary|Part B: Mean SUV of Focal Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb|SUV of focal radioactivity uptake for different organs/tissues was planned to be measured.|Days 3, 4 and 6|All treated Population. Data was not collected as no participants were enrolled in Part B.||||||
2529999|NCT03417830|Secondary|Part A- Session 2: Mean SUV of Focal Radioactivity Uptake After Anti-SAP mAb Dose Between 200 mg and <=500 mg|SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as thyroid gland-goitre hotspot, abdominal skin and skin of the back. Mean SUV derived from PET images has been presented.|Session 2: Days 3, 4 and 5|All treated Population. Only those participants with data available at the specified data points were analyzed.|||Grams per milliliter||Standard Deviation|Mean
2530000|NCT03417830|Secondary|Part A- Session 1: Mean SUV of Focal Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb: Thyriod Gland-goitre Hotspot|SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for thyroid gland-goitre hotspot. Mean SUV derived from PET images has been presented.|Session 1: Days 4 and 6|All treated Population. Only those participants with data available at the specified time points were analyzed.|||Grams per milliliter||Standard Deviation|Mean
2530001|NCT03417830|Secondary|Part A- Session 1: Mean SUV of Focal Radioactivity Uptake After 80-200 mg Dose of Anti-SAP mAb|SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as abdominal skin and skin of the back. Mean SUV derived from PET images has been presented.|Session 1: Days 4, 5, 6 and 8|All treated Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Grams per milliliter||Standard Deviation|Mean
2530002|NCT03417830|Primary|Part B: Mean SUV of Whole Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg|SUV of whole heart was planned to be measured.|Days 3, 4 and 6|All treated Population. Data was not collected as no participants were enrolled in Part B.||||||
2530003|NCT03417830|Primary|Part B: Mean SUV of Whole Heart Following 80-200 mg Dose of Anti-SAP mAb|SUV of whole heart was planned to be measured.|Days 3, 4 and 6|All treated Population. Data was not collected as no participants were enrolled in Part B.||||||
2530004|NCT03417830|Primary|Part A- Session 2: Mean SUV of Whole Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg|SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight.|Session 2: Days 3, 4 and 5|All treated Population. Only those participants with data available at the specified data points were analyzed.|||Grams per milliliter||Standard Deviation|Mean
2530005|NCT03417830|Primary|Part A- Session 1: Mean SUV of Whole Heart Following 80-200 mg Dose of Anti-SAP mAb|SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight.|Session 1: Days 4, 5, 6 and 8|All treated Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Grams per milliliter||Standard Deviation|Mean
2530006|NCT03417830|Primary|Part B: Peak SUV in Focal Anatomical Regions of the Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg|SUV in focal anatomical regions of the heart was planned to be measured.|Days 3, 4 and 6|All treated Population. Data was not collected as no participants were enrolled in Part B.||||||
2530007|NCT03417830|Primary|Part B: Peak SUV in Focal Anatomical Regions of the Heart Following 80-200 mg Dose of Anti-SAP mAb|SUV in focal anatomical regions of the heart was planned to be measured.|Days 3, 4 and 6|All treated Population. Data was not collected as no participants were enrolled in Part B.||||||
2530536|NCT03383627|Primary|Mean HbA1c|HbA1c collected at end of the participation.|14 Days||||mmol/mol||Inter-Quartile Range|Mean
2530008|NCT03417830|Primary|Part A- Session 2: Peak SUV in Focal Anatomical Regions of the Heart Following Anti-SAP mAb Dose Between 200 mg and <=500 mg|SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as blood pool left atrium, blood pool left ventricle, blood pool right ventricle, left ventricle wall - high uptake, left ventricle wall - low uptake, mid septum - high uptake and mid septum - low uptake. Peak SUV values derived from PET images has been presented.|Session 2: Days 3, 4 and 5|All treated Population. Only those participants with data available at the specified data points were analyzed.|||Grams per milliliter||Standard Deviation|Mean
2530009|NCT03417830|Primary|Part A- Session 1: Peak Standardized Uptake Values (SUV) in Focal Anatomical Regions of the Heart Following 80-200 mg Dose of Anti-SAP mAb|SUV was measured radioactivity concentration corrected for radioactive decay and normalized for administered amount of radioactivity per body weight. SUV was analyzed for each region of interest such as blood pool left atrium, blood pool left ventricle, blood pool right ventricle, left ventricle wall - high uptake, left ventricle wall - low uptake, mid septum - high uptake and mid septum - low uptake. Peak SUV values derived from PET images has been presented. All treated population consisted of all participants who received at least one Anti-SAP treatment including 89Zr-GSK2398852.|Session 1: Days 4, 5, 6 and 8|All treated Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Grams per milliliter||Standard Deviation|Mean
2530010|NCT03417713|Secondary|Number of Investigator Procedure Surveys Assessed by Survey Questionnaire|To collect image data acquired during clinical procedures and to collect investigator feedback via surveys on the use of the system during clinical procedures.|Approximately 2 months (duration of subject enrollment)||||Participants|||Count of Participants
2530011|NCT03417713|Primary|Image Guidance Adequacy Collected Via Survey Questionnaire|Number of participants whose procedures were completed using the investigational device.|Approximately 2 months (duration of subject enrollment)||||Participants|||Count of Participants
2530012|NCT03417505|Secondary|Nasal Conjunctival Lissamine Green Staining|Nasal conjunctival lissamine green staining scored from 0 (no staining) to 4 (most staining).|30 days|all participants were analyzed in both lens types|||score on a scale||Standard Deviation|Mean
2530013|NCT03417505|Secondary|Temporal Conjunctival Lissamine Green Staining|Temporal conjunctival lissamine green staining scored 0 (no staining) to 4 (most staining).|30 days|all participants analyzed in both lens types|||score on a scale||Standard Deviation|Mean
2530014|NCT03417505|Secondary|Contact Lens-related Papillary Conjunctivitis|Visual inspection for contact lens-related papillary conjunctivitis with scoring by the Efron grading scale for papillary conjunctivitis [0 (normal) to 4 (severe)] to assess changes after wear of Hydra-PEG treated lenses compared to control lenses.|30 days|all participants were analyzed in each lens type|||score on a scale||Standard Deviation|Mean
2530015|NCT03417505|Secondary|Lid Wiper Epitheliopathy|Fluorescein and lissamine staining to assess lid wiper epitheliopathy using a grading scale to see if there is a change in the height and width of the staining of the lid wiper area with Hydra-PEG treated lenses compared to untreated control lenses. The lid wiper area is the portion of the marginal conjunctival epithelium of the upper eyelid that wipes the ocular surface or lens during blinking. Epitheliopathy is scored on a scale from 0 (best patient outcome) to 3 (worst patient outcome, more staining) on the basis of the horizontal and vertical extent of lid margin staining.|30 days|all participants analyzed with each lens type|||score on a scale||Standard Deviation|Mean
2530016|NCT03417505|Secondary|Tear Breakup Time Over the Surface of the Scleral Lens|Tear breakup time over the surface of the Hydra-PEG treated scleral lens compared to the control lens|30 days|all participants|||seconds||Standard Deviation|Mean
2530017|NCT03417505|Primary|Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)|Validated dry eye questionnaire to assess symptoms after wearing Hydra-PEG treated lenses compared to control lenses. Scale is from 1 to 37, with higher scores indicating more dry eye symptoms.|30 days|all participants|||CLDEQ-8 score||Standard Deviation|Mean
2530018|NCT03417505|Primary|Ocular Surface Disease Index (OSDI) Questionnaire|Dry eye questionnaire to assess symptoms after wearing Hydra-PEG treated lenses compared to control lenses. Patients will be scored from 0 (no dry eye disease) to 100 (severe dry eye disease).|30 days|all participants|||OSDI score||Standard Deviation|Mean
2530019|NCT03417505|Primary|Corneal Fluorescein Staining|Fluorescein staining followed by assessment using the Oxford grading scale (0-5, where 5 indicates the most staining and therefore the most damage to the ocular surface) of the ocular surface after wearing Hydra-PEG treated lenses compared to control lenses|30 days|All participants|||score on a scale||Standard Deviation|Mean
2530020|NCT03417505|Primary|Ocular Surface Tear Breakup Time|Tear breakup time of the ocular surface after wearing lenses|30 days||||seconds||Standard Deviation|Mean
2530021|NCT03417466|Secondary|Consensus Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values|"Consensus Error Grid (or Parkes error grid) compared the paired primary sensor and YSI reference glucose values. Zone A is defined in the Parkes error grid as the zone of clinical accurate measurements with no effect on clinical action, Zone B as altered clinical action with little or no effect on clinical outcome. Ideal situation is 100% in Zone A + B."|YSI FST days (Day 1, 3-4, or 6 of sensor wear)|Subjects who have Enlite sensor inserted and have at least one paired Enlite sensor and YSI measurement. 66 subjects have Enlite sensor inserted, of which one subject has no paired Enlite sensor and YSI measurement.|||percentage of paired readings||95% Confidence Interval|Mean
2530022|NCT03417466|Secondary|Clarke Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values|"Clarke Error Grid compared the paired primary sensor and YSI reference glucose values. Zone A represents a region where sensor values that are within 20% of YSI reference values, or both sensor and YSI reference values are less than 70 mg/dL. Values in Zone A are clinically accurate in that they would lead to clinically correct treatment decisions. Zone B represents sensor values that deviate YSI reference values by more than 20%, but would lead to benign or no treatment. Ideal situation is 100% in Zone A + B."|YSI FST days (Day 1, 3-4, or 6 of sensor wear)|Subjects who have Enlite sensor inserted and have at least one paired Enlite sensor and YSI measurement. 66 subjects have Enlite sensor inserted, of which one subject has no paired Enlite sensor and YSI measurement.|||percentage of paired readings||95% Confidence Interval|Mean
2532531|NCT03303794|Secondary|Opioid Consumption During the First 48 Hours After TKA Surgery|Monitor how much opioid patient consumes|During the first 48 hours after surgery||||milligram||Inter-Quartile Range|Mean
2530023|NCT03417466|Secondary|Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD)|Enlite sensor values from primary sensor were compared to YSI plasma glucose values during YSI FST days (Day 1, 3-4, or 6). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%).|YSI FST days (Day 1, 3-4, or 6 of sensor wear)|Subjects who have Enlite sensor inserted and have at least one paired Enlite sensor and YSI measurement. 66 subjects have Enlite sensor inserted, of which one subject has no paired Enlite sensor and YSI measurement.|||percentage of difference||Standard Deviation|Mean
2530024|NCT03417466|Primary|Mean Percentage of Enlite Sensor Values That Are Within 20% Agreement of Gold Standard (Yellow Springs Instrument (YSI) YSI Plasma Glucose Values)|Primary endpoint is the mean percentage of Enlite Sensor Values from primary sensor that are within 20% agreement of YSI plasma glucose values (within 20 mg/dL if YSI <= 80 mg/dL) during YSI frequent sampling testing (FST) days.|YSI FST days (Day 1, 3-4, or 6 of sensor wear)|Subjects who have Enlite sensor inserted and have at least one paired Enlite sensor and YSI measurement. 66 subjects have Enlite sensor inserted, of which one subject has no paired Enlite sensor and YSI measurement.|||percentage of paired readings||Standard Deviation|Mean
2530025|NCT03417219|Primary|Change From Baseline Perceived Stress Scale (PSS) at 4 Months|The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress. We use a 14 item version of the PSS with a minimum score of 0 and a maximum score of 56. Lower values indicate lower perceived stress while higher values indicate higher perceived stress.|Baseline, 4 month follow-up||||score on a scale||Standard Deviation|Mean
2530026|NCT03417219|Primary|Change From Baseline Center for Epidemiological Studies-Depression (CES-D) at 4 Months|The Center for Epidemiological Studies-Depression (CES-D) is a 20-item, self-report measure of frequency of depressive symptoms over a one week period. The CES-D is frequently used to assess depression in dementia caregivers and has been shown to be sensitive to changes in caregiver depression post intervention. Scores for each item range from 0 (rarely or none of the time) to 3 (most or all of the time), with some items reverse coded. Total scores are calculated by summing all responses and range from 0-60. A higher score is indicative of a worse outcome.|Baseline, 4 month follow-up||||score on a scale||Standard Deviation|Mean
2530027|NCT03417219|Primary|Change From Baseline Zarit Burden Interview (ZBI) at 4 Months|"The Zarit Burden Interview (ZBI) is a 22-item self-report measure of caregiver burden. Several version of the ZBI have been used successfully as outcome measures in interventions for dementia caregivers. Scores for each item range from 0 (never) to 4 (nearly always) on questions such as Do you feel embarrassed by your relative's behavior?. Total scores are calculated by summing all responses and range from 0-88. A higher score is indicative of a worse outcome."|Baseline, 4 month follow-up||||score on a scale||Standard Deviation|Mean
2530028|NCT03417024|Secondary|Breast Cancer Status||Up to 6 years|11 after withdrawals|||Subjects with findings|||Number
2530029|NCT03417024|Secondary|Type of Exams Performed Per Patient||Up to 6 years|All exams performed for enrolled subjects|||Exams completed|||Number
2530030|NCT03417024|Primary|Number of Complete Breast Imaging Datasets||Up to 6 Years|Study terminated prior to follow-up of any participants. No completed datasets were collected.||||||
2530031|NCT03416985|Primary|Gingival Index|"gingival index as evaluated by Silness-Loe Index, Range 0-3: Score 0 = Normal gingiva. Score 1 = Mild inflammation - slight change in color, slight edema. No bleeding on probing.~Score 2 = Moderate inflammation - redness, edema, glazing. Bleeding on probing. Score 3 = Severe inflammation - marked redness and edema, ulceration. Tendency toward spontaneous bleeding."|Baseline, 1 month||||units on a scale||Standard Deviation|Mean
2530032|NCT03416985|Primary|Plaque Index|plaque index as evaluated by Silness-Loe Index: index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).|Baseline, 1 month||||units on a scale||Standard Deviation|Mean
2530033|NCT03415243|Secondary|Number of Participants With Clinically Significant Change in Laboratory Test Values|Haematological, biochemistry, urinalysis and virological parameters were analyzed. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter.|From baseline up to Day 1|Safety population was defined as all participants who received a radiolabeled Treatment A or B irrespective of whether the participant was included in the scintigraphy analysis.|||Participants|||Count of Participants
2530034|NCT03415243|Primary|Small Intestine Transit Time|Small intestinal transit time was calculated by determining the arrival time of the radiolabeled investigational drug formulation at the cecum or colon region from scintigraphic imaging and subtracting the gastric emptying value.|Predose until 10 hours post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||minutes||Full Range|Median
2530035|NCT03415243|Primary|Gastric Emptying Half-Life|Gastric emptying half-life was defined as the time required by the stomach to empty 50% of the ingested meal and was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation.|Predose until 10 hours post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||minutes||Full Range|Median
2530072|NCT03415178|Secondary|Maximum Serum Alirocumab Concentration Observed - Cmax : Single-Arm Period|Cmax: maximum serum concentration observed.|Pre-dose (Week 4, Week 8 and Week 12) and on Day 7, 14, 21 and 28 days following the last injection|"Analysis was performed on PK population of the single-arm period which included all randomized participants who received at least 1 dose or part of a dose of IMP and had at least one evaluable blood sample for PK during this period. Here, Overall number of participants analyzed = participants evaluable for this PK measure."|||ng/mL||Standard Deviation|Mean
2530036|NCT03415243|Primary|Total Area Under the Gastric Emptying Curve|Total area under the gastric emptying curve was evaluated by scintigraphic imaging, performed after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation.|Predose until 10 hours post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage dose*hour||Standard Error|Mean
2530037|NCT03415243|Primary|Area Under the Gastric Emptying Curve From Time 0 to 240 Minutes|Area under the gastric emptying curve from time 0 to 240 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 240 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|240 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage dose*hour||Standard Error|Mean
2530038|NCT03415243|Primary|Area Under the Gastric Emptying Curve From Time 0 to 180 Minutes|Area under the gastric emptying curve from time 0 to 180 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 180 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|180 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage dose*hour||Standard Error|Mean
2530039|NCT03415243|Primary|Area Under the Gastric Emptying Curve From Time 0 to 120 Minutes|Area under the gastric emptying curve from time 0 to 120 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 120 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|120 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage dose*hour||Standard Error|Mean
2530040|NCT03415243|Primary|Area Under the Gastric Emptying Curve From Time 0 to 105 Minutes|Area under the gastric emptying curve from time 0 to 105 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 105 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|105 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage dose*hour||Standard Error|Mean
2530041|NCT03415243|Primary|Area Under the Gastric Emptying Curve From Time 0 to 90 Minutes|Area under the gastric emptying curve from time 0 to 90 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 90 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|90 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage dose*hour||Standard Error|Mean
2530042|NCT03415243|Primary|Area Under the Gastric Emptying Curve From Time 0 to 75 Minutes|Area under the gastric emptying curve from time 0 to 75 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 75 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|75 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage dose*hour||Standard Error|Mean
2530043|NCT03415243|Primary|Area Under the Gastric Emptying Curve From Time 0 to 60 Minutes|Area under the gastric emptying curve from time 0 to 60 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 60 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|60 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage dose*hour||Standard Error|Mean
2530044|NCT03415243|Primary|Area Under the Gastric Emptying Curve From Time 0 to 45 Minutes|Area under the gastric emptying curve from time 0 to 45 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 45 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|45 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage dose*hour||Standard Error|Mean
2530045|NCT03415243|Primary|Area Under the Gastric Emptying Curve From Time 0 to 30 Minutes|Area under the gastric emptying curve from time 0 to 30 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 30 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|30 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage dose*hour||Standard Error|Mean
2530046|NCT03415243|Primary|Area Under the Gastric Emptying Curve From Time 0 to 15 Minutes|Area under the gastric emptying curve from time 0 to 15 was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 15 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|15 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage dose*hour||Standard Error|Mean
2530047|NCT03415243|Primary|Percentage of Radiolabeled Drug Remaining in the Stomach After 240 Minutes of Administration|Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 240 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|240 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage of radiolabeled drug||Standard Deviation|Mean
2530048|NCT03415243|Primary|Percentage of Radiolabeled Drug Remaining in the Stomach After 180 Minutes of Administration|Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 180 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|180 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage of radiolabeled drug||Standard Deviation|Mean
2530049|NCT03415243|Primary|Percentage of Radiolabeled Drug Remaining in the Stomach After 120 Minutes of Administration|Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 120 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|120 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage of radiolabeled drug||Standard Deviation|Mean
2530050|NCT03415243|Primary|Percentage of Radiolabeled Drug Remaining in the Stomach After 105 Minutes of Administration|Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 105 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|105 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage of radiolabeled drug||Standard Deviation|Mean
2530051|NCT03415243|Primary|Percentage of Radiolabeled Drug Remaining in the Stomach After 90 Minutes of Administration|Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 90 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|90 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage of radiolabeled drug||Standard Deviation|Mean
2530052|NCT03415243|Primary|Percentage of Radiolabeled Drug Remaining in the Stomach After 75 Minutes of Administration|Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 75 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|75 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage of radiolabeled drug||Standard Deviation|Mean
2530073|NCT03415178|Secondary|Area Under the Curve-During the Dosing Interval Tau (AUC [0-tau]) : Parallel-Arm Period|AUC0-tau: area under the serum concentration versus time curve calculated using the trapezoidal method during a dosage interval tau, where dosing interval was 4 weeks.|Pre-dose (Week 0) and on Day 7, 14 and 21|Analysis was performed on PK population of the parallel-arm period. Here, “Overall number of participants analyzed” = participants evaluable for this PK measure.|||ng*day/mL||Standard Deviation|Mean
2530053|NCT03415243|Primary|Percentage of Radiolabeled Drug Remaining in the Stomach After 60 Minutes of Administration|Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 60 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|60 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage of radiolabeled drug||Standard Deviation|Mean
2530054|NCT03415243|Primary|Percentage of Radiolabeled Drug Remaining in the Stomach After 45 Minutes of Administration|Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 45 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|45 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage of radiolabeled drug||Standard Deviation|Mean
2530055|NCT03415243|Primary|Percentage of Radiolabeled Drug Remaining in the Stomach After 30 Minutes of Administration|Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 30 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|30 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage of radiolabeled drug||Standard Deviation|Mean
2530056|NCT03415243|Primary|Percentage of Radiolabeled Drug Remaining in the Stomach After 15 Minutes of Administration|Percentage of radiolabeled drug remaining in the stomach was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA) and after 15 minutes of drug ingestion. Data images were analyzed and corrected for radioactive decay and background radiation.|15 minutes post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||percentage of radiolabeled drug||Standard Deviation|Mean
2530057|NCT03415243|Primary|Mean Time for Gastric Emptying by Measuring 90 Percent Values|Mean time to gastric emptying by 90 percent (GE90%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.|Predose until 10 hours post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||minutes||Standard Deviation|Mean
2530058|NCT03415243|Primary|Mean Time for Gastric Emptying by Measuring 50 Percent Values|Mean time to gastric emptying by 50 percent (GE50%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.|Predose until 10 hours post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||minutes||Standard Deviation|Mean
2530059|NCT03415243|Primary|Mean Time for Gastric Emptying by Measuring 25 Percent Values|Mean time to gastric emptying by 25 percent (GE25%) was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.|Predose until 10 hours post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||minutes||Standard Deviation|Mean
2530060|NCT03415243|Primary|Mean Time to Complete Gastric Emptying|Mean time to complete gastric emptying in participants who did not vomit shortly (within 60 minutes) after study drug administration was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 mcCi isotope-technetium-99m-DTPA). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. ROI included the stomach, proximal small intestine, distal small intestine and colon.|Predose until 10 hours post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||minutes||Standard Deviation|Mean
2530074|NCT03415178|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alirocumab : Parallel-Arm Period|Tmax: Time to reach Cmax.|Pre-dose (Week 0) and on Day 7, 14 and 21|Analysis was performed on PK population of the parallel-arm period. Here, “Overall number of participants analyzed” = participants evaluable for this PK measure.|||days||Full Range|Median
2530061|NCT03415243|Primary|Mean Time to Onset of Gastric Emptying|Mean time to onset of gastric emptying in participants who did not vomit shortly (within 60 minutes) after study drug administration was evaluated by scintigraphic imaging, performed immediately after ingestion of the investigational drug formulation (radiolabeled with not more than 108 microcurie [mcCi] isotope-technetium-99m-diethylene-triamine-pentaacetate [DTPA]). Data images were analyzed in a time-lapse format and corrected for radioactive decay and background radiation. Regions of interest (ROI) included the stomach, proximal small intestine, distal small intestine and colon.|Predose until 10 hours post dose on Day 1|Scintigraphy analysis population included all participants who received the radiolabeled treatments A or B and who did not vomit shortly (within 60 minutes) after study drug administration, who had sufficient data to determine time to onset and completion of gastric emptying and who had no major protocol deviations.|||minutes||Standard Deviation|Mean
2530062|NCT03415178|Secondary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8, 12, 16: Single-Arm Period||From Baseline to Weeks 8, 12, and 16|mITT population of single-arm period included all randomized participants who continued in single-arm period & received at least 1 dose/part of a dose of IMP & who had an evaluable baseline & at least 1 on-treatment LDL-C value within analysis windows (Week 8 to 16). Number analyzed=participants with available data at specified time-point.|||percent change||Standard Deviation|Mean
2530063|NCT03415178|Secondary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 4: Parallel-Arm Period|Adjusted least square means and standard errors at Week 4 were calculated from analyses of covariance (ANCOVA) model with the fixed categorical effect of treatment group (SYDNEY, AI), as well as the continuous fixed covariate of baseline LDL-C value.|From Baseline to Week 4|Analysis was performed on modified intent-to-treat (mITT) population of the parallel-arm period which included all randomized participants who received at least 1 dose or part of a dose of IMP during this period and who had an evaluable baseline and an on-treatment LDL-C value within Week 4 analysis window and before second injection, if any.|||percent change||Standard Error|Least Squares Mean
2530064|NCT03415178|Secondary|Number of Participants With Treatment-Emergent Anti-Alirocumab Antibodies (ADA) Positive Response According to ADA Status During Parallel-Arm Period: Single Arm Period|Number of participants with positive ADA during the TEAE period (time from the second IMP injection up to the day of last IMP injection + 70 days) were determined. Treatment-emergent positive ADA response in Single-arm period defined as 1) participants with no ADA positive response in the Parallel-arm period but with any positive response in the Single-arm period or 2) participants with a positive ADA response at baseline, with less than 4-fold increase in titer in the Parallel-arm period (Pre-existing ADA in Parallel-arm period) and at least a 4- fold increase in titer in the Single-arm period.|Week 16|Analysis was performed on ADA population of single-arm period which included all randomized participants who received at least 1 or partial dose of IMP during this period with available baseline and at least 1 post-baseline ADA sample available during this period. Here, “Number analyzed” = participants with ADA assessed at specified time point.|||Participants|||Count of Participants
2530065|NCT03415178|Secondary|Number of Participants With Treatment-Emergent Anti-Alirocumab Antibodies (ADA) Positive Response: Parallel-Arm Period|Anti-drug (alirocumab) antibodies samples were analyzed using a validated electrochemiluminescence assay. Number of participants with positive ADA during treatment emergent adverse event (TEAE) period (time from the first IMP injection to the day before the second IMP injection for participants entered into the single arm period or to 70 days after the first IMP injection, whichever comes first) was determined. Treatment-emergent positive ADA response defined as 1) participants with no ADA positive response at baseline but with any positive response in the post-baseline period or 2) participants with a positive ADA response at baseline and at least a 4- fold increase in titer in the post-baseline period.|Up to Week 4|Analysis was performed on ADA population of the parallel-arm period which included all randomized participants who received at least 1 or part of a dose of IMP during this period with baseline and at least one post-baseline available ADA sample during this period. All participants were analyzed according to the AI device they actually received.|||Participants|||Count of Participants
2530066|NCT03415178|Secondary|Total Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Single-Arm Period|Total PCSK9 concentrations below the LLOQ were set to zero.|Week 16|"Analysis was performed on PK population of the single-arm period. Here, Overall number of participants analyzed = participants evaluable for this PK measure."|||ng/mL||Standard Deviation|Mean
2530067|NCT03415178|Secondary|Total Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Parallel-Arm Period|Total PCSK9 concentrations below the LLOQ were set to zero.|Week 4|Analysis was performed on PK population of the parallel-arm period. Here, “Overall number of participants analyzed” = participants evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2530068|NCT03415178|Secondary|Free Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Single-Arm Period|Free PCSK9 concentrations below the LLOQ were set to zero.|Week 16|"Analysis was performed on PK population of the single-arm period. Here, Overall number of participants analyzed = participants evaluable for this PK measure."|||ng/mL||Standard Deviation|Mean
2530069|NCT03415178|Secondary|Free Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Concentrations : Parallel-Arm Period|Free PCSK9 concentrations below the lower limit of quantification (LLOQ) were set to zero.|Week 4|Analysis was performed on PK population of the parallel-arm period. Here, “Overall number of participants analyzed” = participants evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2530070|NCT03415178|Secondary|Area Under the Curve-During the Dosing Interval Tau (AUC [0-tau]) : Single-Arm Period|AUC0-tau: area under the serum concentration versus time curve calculated using the trapezoidal method during a dosage interval tau, where dosing interval was 4 weeks.|Pre-dose (Week 4, Week 8 and Week 12) and on Day 7, 14, 21 and 28 days following the last injection|"Analysis was performed on PK population of the single-arm period. Here, Overall number of participants analyzed = participants evaluable for this PK measure."|||ng*day/mL||Standard Deviation|Mean
2530071|NCT03415178|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alirocumab: Single-Arm Period|Tmax: Time to reach Cmax.|Pre-dose (Week 4, Week 8 and Week 12) and on Day 7, 14, 21 and 28 days following the last injection|"Analysis was performed on PK population of the single-arm period. Here, Overall number of participants analyzed = participants evaluable for this PK measure."|||days||Full Range|Median
2546646|NCT02918552|Other Pre-specified|Adiponectin|Change in adiponectin|Week 5 (pre drug) to week 16 (post drug); approx. 8 weeks|||||||
2530075|NCT03415178|Secondary|Maximum Serum Alirocumab Concentration Observed - Cmax : Parallel-Arm Period|Cmax: Maximum serum concentration observed.|Pre-dose (Week 0) and on Day 7, 14 and 21|Analysis was performed on pharmacokinetics (PK) population of the parallel-arm period which included all randomized participants who received at least 1 dose or part of a dose of IMP and had at least one evaluable blood sample for PK during this period. Here, “Overall number of participants analyzed” = participants evaluable for this PK measure.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2530076|NCT03415178|Secondary|Injection-Treatment Acceptance Questionnaire (I-TAQ©) After Last Injection (at Week 12) - Overall Acceptance Scores: Single-Arm Period|The I-TAQ© was a well-established and validated questionnaire to measure participant satisfaction with SC auto-injector devices. The I-TAQ© (completed by the participant after the last injection) was self-administered questionnaire administered to participants in order to measure their acceptance of the injection. The overall acceptance is one of the five domain scores. The overall acceptance score ranged from 0 to 100, with 0 indicating low acceptance and 100 indicating high acceptance.|At Week 12|Analysis was performed on safety population of the single-arm period. Here, overall number of participants analyzed = participants who answered the I-TAQ.|||score on a scale||Standard Deviation|Mean
2530077|NCT03415178|Secondary|Patient Perspective Questionnaire After the Last Injection (at Week 12): Single-Arm Period|The aim of the patient perspective questionnaire (completed by the participant after the last injection) was to generate data to support an understanding of the participant experience and satisfaction associated with use of the large volume SYDNEY to administer the 300 mg dose. The questionnaire consisted of 6 questions about level of satisfaction with various aspects of the SYDNEY; with response to each question ranging from 1 (very dissatisfied) to 10 (very satisfied), with higher scores indicated more satisfaction. An additional question (confidence that Sydney device was used correctly) regarding confidence of use of SYDNEY device in the study was evaluated on a scale of 10; where 1 being not at all confident, to 10 being very confident, higher scores indicated more confidence.|At Week 12|Analysis was performed on safety population of the single-arm period.|||score on a scale||Standard Deviation|Mean
2530078|NCT03415178|Secondary|Injection Experience Questionnaire at Initial Supervised Injection: Overall Ease of Use Scores: Parallel-Arm Period|Participants were given an injection experience questionnaire to complete after the self-injection they administered using SYDNEY device or current AI device on Day 1, for assessment of user experience and overall ease-of-use. The questionnaire included 9 questions about specific aspects of using the device. Overall ease of use was the 9th question, response of which ranged from 1 (very difficult) to 10 (very easy), with higher score indicated more ease of use.|Week 0 (Day 1)|Analysis was performed on safety population of the parallel-arm period.|||score on a scale||Standard Deviation|Mean
2530079|NCT03415178|Secondary|Percentage of Participants With SYDNEY-Associated Product Technical Complaint (PTCs) (Overall and by Type) at the Unsupervised Injections : Single-Arm Period|"A PTC was defined as any complaint reported on the participant complaint form that triggered an investigation by the device department and was categorized as either device-related, participant-related, or undetermined, whether or not associated with an AE. Percentage of Participants With a SYDNEY-associated PTC (for the reporting arm Alirocumab from new auto-injector device [SYDNEY]) are reported."|From Week 4 up to Week 12|Analysis was performed on safety population of the single-arm period.|||percentage of participants|||Number
2530080|NCT03415178|Secondary|Percentage of Participants With a SYDNEY or Current Auto-Injector (AI)-Associated Product Technical Complaint (PTCs) (Overall and by Type) at the Supervised Injections on Week 0 (Day 1): Parallel-Arm Period|"A PTC was defined as any complaint reported on the participant complaint form that triggered an investigation by the device department and was categorized as either device-related, participant-related, or undetermined, whether or not associated with an AE. Percentage of participants With a SYDNEY-associated PTC (for the reporting arm Alirocumab from new auto-injector device) or Current AI-Associated PTCs (for the reporting arm alirocumab from AI device) are reported."|Week 0 (Day 1)|Analysis was performed on safety population of the parallel-arm period which included all randomized participants who received at least 1 dose or part of a dose of IMP during this period.|||percentage of participants|||Number
2530081|NCT03415178|Primary|Percentage of SYDNEY-Associated Product Technical Complaints (PTCs) (by Type) at the Unsupervised Injections: Single-Arm Period|SYDNEY-associated PTC was defined as any complaint reported on the participant complaint form that triggered an investigation by the device department and was categorized as either device-related, participant-related, or undetermined whether or not associated with an AE.|From Week 4 up to Week 12|Analysis was performed on safety population of the single-arm period.|||percentage of PTCs|Number of unsupervised injections||Number
2530082|NCT03415178|Primary|Percentage of SYDNEY-Associated Product Technical Complaints (PTCs) (Overall) at the Unsupervised Injections: Single-Arm Period|SYDNEY-associated PTC was defined as any complaint reported on the participant complaint form that triggered an investigation by the device department and was categorized as either device-related, participant-related, or undetermined whether or not associated with an adverse event (AE). Overall category included total of all 3 types of PTCs. The percentage of SYDNEY-associated PTCs was calculated as: Number of PTCs / Number of unsupervised injections*100. The confidence interval (CI) was calculated using the Wilson score method.|From Week 4 up to Week 12|Analysis was performed on safety population of the single-arm period which included all randomized participants who continued in the single-arm period and received at least 1 dose or part of a dose of investigational medicinal product (IMP) during this period.|||percentage of PTCs|Number of unsupervised injections|95% Confidence Interval|Number
2530083|NCT03414359|Secondary|Secondary Outcome: Number of Participants With Requirement for Intraoperative Analgesia Supplementation|This requirement for any rescue medications to control discomfort or pain during CD|1 hour||||Participants|||Count of Participants
2530084|NCT03414359|Primary|The Onset Time to Surgical Anesthesia|The onset time to surgical anesthesia, as reported by the participant using a standard procedure This will be measured by the time taken from the end of the epidural loading dose to develop a loss of touch sensation using a neurotip® (Owen Mumford, USA) device bilaterally at the T7 dermatomal level using a non-inferiority study design. A non-inferiority limit of 3 minutes was chosen apriori.|Up to 35 minutes|Per protocol analysis|||seconds||Standard Deviation|Mean
2530085|NCT03413618|Secondary|Minor Bleeding|any non-major or non-clinically relevant bleeding does not require the suspension of therapy and changes in the patient's lifestyle|12 months||||Participants|||Count of Participants
2530087|NCT03413618|Secondary|Major Bleeding|according to the International Society of Thrombosis and Hemostasis (ISTH) definition, major bleeding defined as fatal bleeding, and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level of 20 g/L or 1.24 mmol/L or more, or leading to transfusion of two or more units of whole blood or red cells|12 months||||Participants|||Count of Participants
2530088|NCT03413618|Secondary|Adverse Events|any adverse events detected or suspected|12 months||||Participants|||Count of Participants
2530089|NCT03413618|Secondary|Extension of Residual Venous Obstruction by Marder Score|Residual venous obstruction (RVO) defined as a thrombotic masses occupying 20% and more of the vein cross-sectional diameter was measured by duplex ultrasound and calculated as the vein cross-sectional diameter under the maximal compression divided on the diameter without compression and multiplied by 100%. The extension of RVO was assessed by Marder score, the sum of all affected venous segments, evaluated by different scores (see Appendix of the Protocol), that ranged from 0 (no RVO) to 34 (RVO in all possible venous segments in one limb).|12 months||||Marder score||Standard Deviation|Mean
2530090|NCT03413618|Secondary|Number of Participants With Full Recanalization of the Popliteal Vein|Full recanalization of popliteal vein suggests the residual venous obstruction (RVO) less than 20%. The RVO was assessed by duplex ultrasound and calculated as the vein cross-sectional diameter under the maximal compression divided on the diameter without any compression multiplied by 100%.|12 months||||Participants|||Count of Participants
2530091|NCT03413618|Secondary|The Value of Chronic Lower Limb Venous Insufficiency Questionnaire - 20 Items|Chronic Lower Limb Venous Insufficiency Questionnaire - 20 items (CIVIQ-20) is a venous specific questionnaire to assess the disease-specific quality of life (QoL). It contains 20 items of 1-5 scores, totally, from 20 (best QoL) to100 (worst QoL) scores.|12 months||||CIVIQ-20 scores||Standard Deviation|Mean
2530092|NCT03413618|Secondary|The Value of Venous Clinical Severity Score|Venous Clinical Severity Score (VCSS) is a combination of subjective symptoms and objective signs of CVD aimed to assess the severity of disease and ranges from 0 (no signs and symptoms of CVD) to 30 (severe signs and symptoms of CVD)|12 months||||VCSS score||Standard Deviation|Mean
2530093|NCT03413618|Secondary|Number of Participants With Symptomatic Pulmonary Embolism|detection of symptomatic pulmonary embolism verified with CT pulmonary angiogram|12 months||||Participants|||Count of Participants
2530094|NCT03413618|Secondary|Number of Participants With Recurrent Symptomatic or Asymptomatic DVT|detection of any episode of recurrent DVT with or without clinical signs verified by duplex ultrasound|12 months||||Participants|||Count of Participants
2530095|NCT03413618|Primary|Number of Participants With Postthrombotic Syndrome as Determined by Villalta Score|Detection of the postthrombotic syndrome (PTS) was made according to the Villalta score (a combination of 5 subjective symptoms and 6 objective signs of chronic venous disease) ranged from 0 (no signs) to 33 scores (maximal severity). PTS defined as 5 and more scores; mild PTS as 5-9 scores; moderate PTS as 10-14 scores; severe PTS as 15 and more scores.|12 months||||Participants|||Count of Participants
2530096|NCT03412929|Secondary|Bates-Jensen Wound Assessment Tool Score|The Bates-Jensen Wound Assessment tool score will be used to assess the wound's status. The Bates-Jensen Wound Assessment tool measures wound status. The wound size score ranges from 0 to 5. The wound depth score ranges from 0 to 5. The wound edge score ranges from 0 to 5. The wound undermining score ranges from 0 to 5. The necrotic tissue type score ranges from 1 to 5. The necrotic tissue amount ranges from 1 to 5. The exudate type score ranges from 1 to 5. The exudate amount score ranges from 1 to 5. The skin color surrounding wound score ranges from 1 to 5. The peripheral tissue edema score ranges from 1 to 5. The peripheral tissue induration score score ranges from 1 to 5. The granulation tissue score ranges from 1 to 5. The epithelialization score ranges from 1 to 5. The total score from these sub-scores added together is used as the total BWAT score. For all sub-score values, a value of 0 or 1 is a better outcome. The minimum total score is 9 and the maximum total score is 65.|The BWAT score will be recorded at weekly visits over fours weeks for each subject.||||score on a scale||95% Confidence Interval|Mean
2530097|NCT03412929|Secondary|Pain Score|The pain score will be recorded with a visual analog scale from 0-10. 0 is interpreted as no pain and 10 is the worst imaginable pain.|The pain score will be recorded at weekly visits over four weeks for each subject.||||score on a scale||Full Range|Median
2530098|NCT03412929|Secondary|Odor|The odor score will be recorded using a scale of 1-4 with a score of 1 being pleasant odor to 4 being an unpleasant odor.|The odor score will be recorded at weekly visits over four weeks for each subject.|Study staff reported scores of 0 when no odor was detectable.|||score on a scale||Full Range|Median
2530099|NCT03412929|Secondary|Infections|Number of infections in the wound sites will be recorded.|From initial date of application to weekly visits assessed up to 4 weeks.||||Participants|||Count of Participants
2530100|NCT03412929|Secondary|Wound Closure|Percent of patients with 100% wound closure in each group|From initial date of application to weekly visits assessed up to 4 weeks.||||Participants|||Count of Participants
2530101|NCT03412929|Primary|Change in Necrotic Tissue|The percent change in necrotic tissue will serve as the primary endpoint.|From initial date of application to weekly visits assessed up to 4 weeks.||||percent of necrotic tissue||95% Confidence Interval|Mean
2530102|NCT03412019|Secondary|Hemodynamic Parameter (Mean Arterial Pressure, MAP)|This is the post-procedure mean arterial pressure of the patients.|post procedure||||mmHg||Standard Deviation|Mean
2530103|NCT03412019|Secondary|Patient Anxiety|Change in anxiety before and after surgery using a numeric rating scale from 0 (no anxiety at all) to 10 (greatest anxiety)|Perioperatively||||NRS scale (0-10)||Standard Deviation|Mean
2530104|NCT03412019|Primary|Patient Satisfaction|"This outcome will be measured using Morgan's Maternal Satisfaction Scale for Cesarean Section (MSSCS).~It is a 22-item questionnaire, each item have a Likert scale from 1-7 (1 =strongly disagree, 7=strongly agree), yielding a composite (total) score ranging 22-154, representing lowest to highest satisfaction. The questionnaire will be given to participants on post-operative day one during the hours of 8am-1pm."|1 Day||||units on a scale||Standard Deviation|Mean
2530371|NCT03400449|Primary|Total Counseling Time|Duration of counseling in minutes (from initiation of counseling to conclusion of all questions answered.) The clock was not stopped for breaks, which were allowed as needed.|Immediately following the intervention, an average of less than 30 minutes||||minutes||Standard Deviation|Mean
2530105|NCT03410628|Secondary|Change in Headache Pain Severity From Baseline to 120 Minutes for First Treated Migraine Attack|At the onset of headache pain subjects self-administered treatment with the study device and completed headache pain scores using a 4 point scale (where 3 = severe, 2 = moderate, 1 = mild and 0 = no pain) at baseline (0 minutes) and 120 minutes.|120 minutes|Safety population, 6 subjects had missing data|||units on a scale||Full Range|Mean
2530106|NCT03410628|Primary|Safety - Number of Participants With Adverse Events|Safety was assessed by collecting adverse events for the duration of the study|Up to 4 months|safety population|||Participants|||Count of Participants
2530107|NCT03409731|Secondary|Number of Death/MI/Any Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|0 to 90 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530108|NCT03409731|Secondary|Number of Death/MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|0 to 30 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530109|NCT03409731|Secondary|Number of Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 90 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530110|NCT03409731|Secondary|Number of Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 30 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530111|NCT03409731|Secondary|Number of Participants With All Coronary Revascularization|Coronary revascularization attributed to either Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI)|0 to 90 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530112|NCT03409731|Secondary|Number of Participants With All Coronary Revascularization|Coronary revascularization attributed to either Coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI)|0 to 30 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530113|NCT03409731|Secondary|Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|0 to 90 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530114|NCT03409731|Secondary|Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|0 to 30 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530115|NCT03409731|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|0 to 90 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530116|NCT03409731|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|0 to 30 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530117|NCT03409731|Secondary|Number of Participants With Ischemic-Driven Target Lesion Revascularization (ID-TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|0 to 90 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530118|NCT03409731|Secondary|Number of Participants With Ischemic-Driven Target Lesion Revascularization (ID-TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|0 to 30 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530119|NCT03409731|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|0 to 90 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530120|NCT03409731|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|0 to 30 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530121|NCT03409731|Secondary|Number of Participants With Target Vessel Myocardial Infarction (TV-MI)|Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)|0 to 90 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530122|NCT03409731|Secondary|Number of Participants With Target Vessel Myocardial Infarction (TV-MI)|Myocardial infarction attributed to target vessel myocardial infarction (TV-MI)|0 to 30 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530123|NCT03409731|Secondary|Number of Participants With All Myocardial Infarction (MI)|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)"|0 to 90 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530124|NCT03409731|Secondary|Number of Participants With All Myocardial Infarction (MI)|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)"|0 to 30 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530125|NCT03409731|Secondary|Number of Cardiac Death|Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 90 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530126|NCT03409731|Secondary|Number of Cardiac Death|Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment|0 to 30 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530127|NCT03409731|Secondary|Number of All Death (Cardiac, Vascular, Non-Cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 90 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530128|NCT03409731|Secondary|Number of All Death (Cardiac, Vascular, Non-Cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 30 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530129|NCT03409731|Secondary|Number of Cardiac Death/Myocardial Infarction (MI)|Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 90 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530130|NCT03409731|Secondary|Number of Cardiac Death/Myocardial Infarction (MI)|Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 30 days|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530131|NCT03409731|Primary|Number of Participants With Composite of Device Deficiencies|"Device deficiencies: Number of participants with at least one of the following Device deficiencies~Lesion/implant failure~Delivery difficulty (finally delivered)~Re-crossing failure~Re-crossing difficulty~Post-dilatation balloon~Optical Coherence Tomography (OCT)/Intravascular Ultrasound (IVUS)~Instruction for Use (IFU) not included~Major Strut Malapposition~Strut Fracture within 6 months"|During index procedure|Full Analysis Set (all participants with Absorb GT1)|||Participants|||Count of Participants
2530132|NCT03409731|Primary|Number of Participants With Cumulative Scaffold Thrombosis|"Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%).~Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|0 to 90 days|Full Analysis Set (all participants with Absorb GT1)|||participants|||Number
2530151|NCT03408392|Secondary|Respiratory Rate at Indicated Time-points|Respiratory rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.|Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Breaths per minute||Standard Deviation|Mean
2530133|NCT03409731|Primary|Number of Participants With Late Scaffold Thrombosis (ST)|"Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|31 to 90 days|Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System|||participants|||Number
2530134|NCT03409731|Primary|Number of Participants With Sub Acute Scaffold Thrombosis (ST)|"Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%).~Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|>1 to 30 days|Full Analysis Set (all participants with Absorb GT1)|||participants|||Number
2530135|NCT03409731|Primary|Number of Participants With Acute Scaffold Thrombosis (ST)|"Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%).~Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|Day 0|Full Analysis Set (all participants with Absorb GT1)|||participants|||Number
2530136|NCT03408639|Secondary|The Incidence of Adverse Events|The incidence of adverse events during 26 weeks.|26 weeks||||Participants|||Count of Participants
2530137|NCT03408639|Secondary|The Proportion of Patients With an Increase in Hb Concentration of > 1.0 g/dl for Four Consecutive Weeks|The proportion of patients with an increase in Hb concentration of > 1.0 g/dl for four consecutive weeks during 26 weeks.|26 weeks||||Participants|||Count of Participants
2530138|NCT03408639|Secondary|The Incidence of Hb Levels Above 13 g/dl|The first safety endpoint is the proportion of patients with at least one Hb measurement above 13 g/dL.|26 weeks||||Participants|||Count of Participants
2530139|NCT03408639|Secondary|The Percentage of Patients With Hematocrit Measurements More Than 30%|The percentage of patients with hematocrit measurements more than 30% from week 22 to week 26.|Week 22 to week 26||||percentage of patients|||Number
2530140|NCT03408639|Secondary|The Percentage of Patients With Hb Measurements More Than 10.0 g/dl|The percentage of patients with Hb measurements more than 10.0 g/dl from week 22 to week 26.|Week 22 to week 26||||Participants|||Count of Participants
2530141|NCT03408639|Secondary|The Proportion of Patients With Maintenance Success|Maintenance success is considered as maintenance success is considered as maintenance of mean Hb concentration of 11.0 ± 1.0 g/dl for at least four consecutive weeks|26 weeks||||proportion of patients|||Number
2530142|NCT03408639|Secondary|The Proportion of Patients With Treatment Success|Treatment success is considered as Hb concentration equal to or more than 11.0 g/dl and two consecutive weeks without any blood transfusion within the preceding three months|Week 12 to week 26||||proportion of patients|||Number
2530143|NCT03408639|Secondary|The Proportion of Patients Needed Blood Transfusions|The proportion of patients needed blood transfusions during 26 weeks.|26 weeks||||proportion of patients|||Number
2530144|NCT03408639|Secondary|The Proportion of Patients With Any Hb Measurement Outside the Target Range (10-12 g/dl)|The proportion of patients with any Hb measurement outside the target range (10-12 g/dl) during 26 weeks.|26 weeks||||proportion of patients|||Number
2530145|NCT03408639|Secondary|The Proportion of Patients With Any Permanent or Transient Dose Change|The proportion of patients with any permanent or transient dose change during 26 weeks.|26 weeks||||proportion of patients|||Number
2530146|NCT03408639|Primary|Mean Weekly Epoetin Dosage Per kg Body Weight During the Last Four Weeks of Treatment|The mean weekly epoetin dosage per kg body weight during the last four weeks of treatment necessary to maintain the Hb level within 10-12 g/dl during the last four weeks of treatment is considered as the second primary endpoint.|Week 22 to week 26||||IU/Kg/week||Standard Deviation|Mean
2530147|NCT03408639|Primary|Mean Hb Change Level During the Last Four Weeks of Treatment|The primary endpoints of this study is to assess mean Hb change level during the last four weeks of treatment.|Week 22 to week 26||||g/dL||Standard Deviation|Mean
2530148|NCT03408392|Secondary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points|Blood pressure of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.|Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
2530149|NCT03408392|Secondary|Body Temperature at Indicated Time-points|Body temperature of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.|Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Degree Celsius||Standard Deviation|Mean
2530150|NCT03408392|Secondary|Pulse Rate at Indicated Time-points|Pulse rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest.|Day 1 Pre-dose 1.5 hours, Day 1 post-dose 2, 4, and 6 hours and Day 2 post-dose 24 hours of each treatment period|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2546968|NCT02915029|Secondary|High-density Lipoprotein HDL Cholesterol|Change in serum HDL cholesterol on study|12 months minus baseline values||||mg/dl||Inter-Quartile Range|Mean
2530152|NCT03408392|Secondary|Number of Participants With Potential Clinical Importance (PCI) Abnormal Findings for Urinalysis|Urine samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2. PCI ranges for urinalysis parameters were as follows: specific gravity 1.001 to 1.035 kilogram per liter, blood negative (0 to 9) RBC per microliter, pH 4.6 to 8.0, protein negative (0.0 to 0.14) gram per liter, glucose negative (0 to 5.49) millimoles per liter, ketones negative (0.0 to 0.49) millimoles per liter, urobilinogen (0.0 to 1.0) milligrams per deciliter, urine leucocytes negative (0 to 14) leucocytes per microliter, Urine WBC, RBC and epithelial cells 0 to 5 high power per field.|Day -1 and Day 2 of each treatment period|Safety Population. Only those participants with data available at the specified time points were analyzed|||Participants|||Count of Participants
2530153|NCT03408392|Secondary|Percent Reticulocytes at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of percent reticulocytes.|Day -1 and Day 2 of each treatment period|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Percentage of reticulocytes||Standard Deviation|Mean
2530154|NCT03408392|Secondary|Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including MCHC and Hb.|Day -1 and Day 2 of each treatment period|Safety Population. Only those participants with data available at the specified time points were analyzed|||Grams per deciliter||Standard Deviation|Mean
2530155|NCT03408392|Secondary|Hematocrit at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematocrit.|Day -1 and Day 2 of each treatment period|Safety Population. Only those participants with data available at the specified time points were analyzed|||Proportion of red blood cells in blood||Standard Deviation|Mean
2530156|NCT03408392|Secondary|Erythrocyte Count at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of erythrocyte count.|Day -1 and Day 2 of each treatment period|Safety Population. Only those participants with data available at the specified time points were analyzed.|||10^12 cells per liter||Standard Deviation|Mean
2530157|NCT03408392|Secondary|Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCH.|Day -1 and Day 2 of each treatment period|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Picogram||Standard Deviation|Mean
2530158|NCT03408392|Secondary|Mean Corpuscular Volume (MCV) at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCV.|Day -1 and Day 2 of each treatment period|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Femtoliter||Standard Deviation|Mean
2530159|NCT03408392|Secondary|Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including platelets, neutrophils, monocytes, lymphocytes, leucocyte, eosinophils and basophils.|Day -1 and Day 2 of each treatment period|Safety Population. Only those participants with data available at the specified time points were analyzed.|||10^9 cells per liter||Standard Deviation|Mean
2530160|NCT03408392|Secondary|Total Protein at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of total Protein.|Day -1 and Day 2 of each treatment period|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Grams per liter||Standard Deviation|Mean
2530161|NCT03408392|Secondary|Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including total bil, direct bil and creat.|Day -1 and Day 2 of each treatment period|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Micromoles per liter||Standard Deviation|Mean
2530162|NCT03408392|Secondary|Calcium, Glucose, Potassium and Sodium at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including calcium, glucose, potassium and sodium.|Day -1 and Day 2 of each treatment period|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Millimoles per liter||Standard Deviation|Mean
2530163|NCT03408392|Secondary|Blood Urea Nitrogen (BUN) at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of BUN.|Day -1 and Day 2 of each treatment period|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Milligrams per deciliter||Standard Deviation|Mean
2530164|NCT03408392|Secondary|Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), and Aspartate Aminotransferase (AST) at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including ALT, ALP and AST.|Day -1 and Day 2 of each treatment period|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Units per liter||Standard Deviation|Mean
2530165|NCT03408392|Secondary|Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations. The analysis was performed on Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.|Up to Day 16 in each treatment period|Safety Population|||Participants|||Count of Participants
2530251|NCT03405818|Primary|Change From Baseline in Hematology Parameter (Hematocrit) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||volume percentage of red blood cells||Standard Deviation|Mean
2530166|NCT03408392|Secondary|Terminal Phase Half-life (T1/2) for Cefixime|Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period|Pharmacokinetic Population|||Hours||Geometric Coefficient of Variation|Geometric Mean
2530167|NCT03408392|Secondary|Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for Cefixime|Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period|Pharmacokinetic Population|||Percentage of AUCex||Geometric Coefficient of Variation|Geometric Mean
2530168|NCT03408392|Secondary|Time of Occurrence of Cmax (Tmax) for Cefixime|Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Tmax of cefixime was analyzed using a nonparametric test to compute point estimate of the median and full range.|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period|Pharmacokinetic Population|||Hours||Full Range|Median
2530169|NCT03408392|Secondary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to (AUC [0-infinity]) Across All Treatments for Cefixime|Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period|Pharmacokinetic Population|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2530170|NCT03408392|Primary|Maximum Observed Plasma Concentration (Cmax) Within a Participant Across All Treatments of Cefixime|Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods.|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period|Pharmacokinetic Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2530171|NCT03408392|Primary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) for Cefixime|Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of cefixime under fasted state. Pharmacokinetic analysis of cefixime was conducted using non-compartmental methods. Pharmacokinetic Population comprised of participants who completed the study and for whom primary pharmacokinetic parameters could be calculated for all treatment periods were included in the statistical pharmacokinetic analysis of the study.|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0 8.0, 10.0, 12.0, 16.0 and 20.0 hours post dose on Day 1, 24.00 hours post dose on Day 2 of each treatment period|Pharmacokinetic Population|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2530172|NCT03408171|Secondary|Length of Longest Piece||Number Analyzed||||mm||Full Range|Median
2530173|NCT03408171|Secondary|Specimen Quality for Histologic Diagnosis|Number of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle.|3-5 days||||Participants|||Count of Participants
2530174|NCT03408171|Secondary|No. of Fragments > 9 mm, Mean (SD)|No. of fragments > 9 mm, mean (SD) Pre-processing Post-processing|3-5 days||||Number of Fragments||Standard Deviation|Mean
2530175|NCT03408171|Secondary|Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads|Portal triads groups, n (%) < 11 Portal triads > 11 Portal triads|3-5 days||||Participants|||Count of Participants
2530176|NCT03408171|Secondary|Portal Triads Quantity (Median)|Number of portal triads (PT) in the specimen.|3-5 days||||Complete number of portal triads||Full Range|Median
2530177|NCT03408171|Secondary|Portal Triads Number (Mean)|Number of portal triads (PT) in the specimen.|3-5 days||||Portal Triads||Standard Deviation|Mean
2530178|NCT03408171|Secondary|Post-processing Aggregate Specimen Length (ASL)|Post-processing Aggregate specimen length (ASL) measured in centimeter|3-5 days||||centimeter||Standard Deviation|Mean
2530179|NCT03408171|Secondary|Pre-processing Aggregate Specimen Length (ASL)|Pre-processing Aggregate specimen length (ASL) measured in centimeter|3-5 days||||centimeter||Standard Deviation|Mean
2530180|NCT03408171|Secondary|Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm|"Pre-processing Length of the longest piece (LLP) subgroups:~< 2 cm > 2cm"|3-5 days||||Participants|||Count of Participants
2530181|NCT03408171|Secondary|Post-processing Length of the Longest Piece (LLP)|Post-processing Length of the longest piece (LLP) measured in centimeter|3-5 days||||centimeter||Standard Deviation|Mean
2530182|NCT03408171|Primary|Pre-processing Length of the Longest Piece (LLP)|Pre-processing Length of the longest piece (LLP) measured in centimeter|up to 5 days||||centimeter||Standard Deviation|Mean
2530183|NCT03407612|Secondary|Pain Level|Change in pain level measured on a Likert-type scale from 0 to 10, with higher scores representing higher pain levels.|Initial two postoperative weeks||||units on a scale||Standard Deviation|Mean
2530184|NCT03407612|Secondary|Analgesic Usage|Analgesic usage measured via the morphine-equivalent dose of consumed analgesic medications|Initial two postoperative weeks||||morphine equivalent doses||Standard Deviation|Mean
2532720|NCT03294629|Secondary|Average Pressures of Auto-CPAP Machine|Average Pressures of Auto-CPAP Machine (Objective data recorded in the auto-CPAP machine)|2 weeks||||cmH2O||Standard Deviation|Mean
2530185|NCT03407612|Primary|Change in Patient Satisfaction and Functional Outcome|Hip Outcome Score Activities of Daily Living (HOS ADL) questionnaire completed at specific time points. Completion of the HOS ADL provides a score from 0 to 100, with a higher score corresponding to greater level of function. The improvement preoperative to 6 month postoperative scores was also computed.|Baseline and 6 weeks, 12 weeks, and 6 months postoperatively||||units on a scale||Standard Deviation|Mean
2530186|NCT03407430|Secondary|Number of Subjects That Experienced a Grade 2 or Higher Adverse Events When Taking Pregabalin|CTCAE The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.|Up to 12 weeks||||Participants|||Count of Participants
2530187|NCT03407430|Secondary|Maximum Neuropathic Pain Score Between Pregabalin and Placebo Across the 2 Cycles|"Compare the maximum neuropathic pain score between pregabalin and placebo within cycle 1 and across the 2 cycles.~The ID Pain scale (also know as the Identify Pain scale) is a 6-item, participant-completed screening tool designed to help differentiate nociceptive and neuropathic pain. This pain score also helps to evaluate the presence/absence of neuropathic pain at a given point of time.~Did the pain feel like pins and needles?~Did the pain feel hot/burning?~Did the pain feel numb?~Did the pain feel like electrical shocks?~Is the pain made worse with the touch of clothing or bed sheets?~Is the pain limited to your joints?~A yes response to questions 1-5 are scored as 1; for question 6, a yes is scored as −1. As such, higher scores (approaching 5) signify worse outcomes. The scale's total range for a patient is -1 to 5."|Up to 12 weeks||||units on a scale||Full Range|Mean
2530188|NCT03407430|Secondary|Maximum Change in Pain Score From Baseline Between Pregabalin and Placebo Across the 2 Cycles|"Compare the maximum change in pain score from baseline between pregabalin and placebo within cycle 1 and across the 2 cycles.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying no pain and 10 signifying the worst pain you can imagine. Each patient will be assessed regularly, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2)."|Up to 12 weeks||||units on a scale||Full Range|Mean
2530189|NCT03407430|Secondary|Proportion of Patients With Severe Pain Between Pregabalin and Placebo Across the 2 Cycles|"Compare the proportion of patients with severe pain between pregabalin and placebo within cycle 1 and across the 2 cycles.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying no pain and 10 signifying the worst pain you can imagine."|Up to 12 weeks||||proportion|||Number
2530190|NCT03407430|Secondary|Number of Days of Breakthrough Analgesic Use Between Pregabalin and Placebo Across the 2 Cycles|"Compare the number of days of breakthrough analgesic use between pregabalin and placebo within cycle 1 and across the 2 cycles.~The number of days of breakthrough analgesic use (i.e additional pain medication being required) is evaluated based on participant-provided medication logs kept during study treatment. If additional pain medication outside of their normal pain control regimen was reported, this day counts as 1. The total days for each patient are then reported, with a total range from zero to 14 (for patients with breast cancer) or zero to 21 (for patients with a lymphoma)."|Up to 12 weeks||||days||Full Range|Mean
2530191|NCT03407430|Secondary|Proportion of Patients Who Have an Increase in Bone/Joint Pain Score of ≥ 3 From Baseline Through the End of Study Medication in Cycle 1|"Compare the proportion of patients who have an increase in bone/joint pain score of ≥ 3 from baseline through the end of study medication in cycle 1 between Arm A and Arm B.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying no pain and 10 signifying the worst pain you can imagine."|Up to 12 weeks||||proportion|||Number
2530192|NCT03407430|Secondary|Proportion of Patients Who Have an Increase in Pain Score of ≥ 3 From Baseline Between Pregabalin and Placebo Across the 2 Cycles|"Compare the proportion of patients who have an increase in pain score of ≥ 3 from baseline between pregabalin and placebo across the 2 cycles.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying no pain and 10 signifying the worst pain you can imagine."|Up to 12 weeks||||proportion|||Number
2530193|NCT03407430|Primary|Number of Patients Who Have an Increase in Pain Score of ≥ 3 From Baseline Through the End of Study Medication in Cycle 1|"Compare the proportion of patients who have an increase in pain score of ≥ 3 from baseline through the end of study medication in cycle 1 between Arm A and Arm B.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying no pain and 10 signifying the worst pain you can imagine."|Up to 12 weeks||||Participants|||Count of Participants
2530194|NCT03406325|Primary|Cell Yield Per 100ml Blood|Cell yield of patient's mast cell culture after 9 weeks in culture as an index of cell growth and differentiation.|Mast cells studied after 9 weeks in culture|Mast cells derived from 7 allergic patients were analysed and reported individually. Patients in the validation group were not measured for this outcome and their samples were only used to validate the assay.|||Cell yield per 100ml blood|||Number
2530195|NCT03406325|Primary|Percentage of Histamine Release by Patient's Mast Cells + Patient's Serum + Allergen|Percentage of total histamine release when patient's mast cells were activated with patient's own serum and Der p2. Each patient's results are reported individually.|Mast cells studied after 9 weeks in culture|Mast cells derived from 7 allergic patients were analysed and reported individually. Patients in the validation group were not measured for this outcome and their samples were only used to validate the assay.|||percentage of histamine release|||Number
2530293|NCT03404167|Primary|Apparent Oral Clearance (CL/F) of Zoliflodacin|Apparent oral clearance (CL/F) computed as Dose/Area under the curve (AUC) from time zero to infinity (0-8) computed from concentrations that were measured using a validated high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method.|Day 1 to Day 4|The analysis population consists of all eight participants.|||L/h||Standard Deviation|Mean
2530196|NCT03406325|Primary|Percentage Histamine Release by Patient's Mast Cells + Immunoglobulin E (IgE)/Anti-IgE|percentage of total histamine release by patient's mast cells that had been activated with anti-IgE|Mast cells studied after 9 weeks in culture|Mast cells derived from 7 allergic patients were analysed and reported individually. Patients in the validation group were not measured for this outcome and their samples were only used to validate the assay.|||percentage of histamine release|||Number
2530197|NCT03406325|Primary|Percentage Histamine Release by Normal Average Responder Mast Cells + Patient's Serum to Assess Autoreactivity|percentage of total histamine release by normal average responder mast cells that had been activated with patient's serum|Mast cells studied after 9 weeks in culture|Mast cells derived from the validation group is reported as a group (mean +/-SD). The other 7 allergic patients were analysed and reported individually as explained earlier.|||percentage of histamine released||Standard Deviation|Mean
2530198|NCT03406325|Primary|Evaluation of Patient's Serum for Autoreactivity on Normal Average Responder Mast Cell Activation|Patient's serum was incubated with mast cells derived from normal donors for detection of mast cell activation as evidenced by histamine release.|Mast cells studied after 9 weeks in culture|Serum samples were obtained from 19 patients in total, of whom 12 were in the validation group. The other 7 patients were studied more extensively in the trial and their data is reported individually in this section and thereafter.|||Participants|||Count of Participants
2530199|NCT03406325|Primary|Mast Cell Activation Test Results for Validation Group|Mast Cell Activation Test results of high/low level of house dust mite sensitivity by using normal donor cultured mast cells for validation.|Mast cells studied after 9 weeks in culture|Mast cells were cultured from blood of normal donors to validate the (Mast Cell Activation) MAT assay. The serum samples were obtained from allergic patients with sensitivities to Der p2 and used for passive sensitization of normal donor mast cells followed by their activation by Der p2 allergen. Data were collected only from the validation group.|||Participants|||Count of Participants
2530200|NCT03406260|Secondary|PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan|PK: Area under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of Lasmiditan.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours, postdose|All randomized participants who received at least one dose of study drug and have evaluable PK data.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2530201|NCT03406260|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours, postdose|All randomized participants who received at least one dose of study drug and have evaluable pharmacokinetics (PK) data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2530202|NCT03406260|Primary|Pharmacodynamics: Change From Baseline in Peak Hourly Mean Values of Systolic Blood Pressure (SBP)|Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using linear mixed effects model adjusting for baseline, treatment, treatment sequence, period, treatment by time point interaction, and a random effect of participant.|Baseline through 24 hours after each administration of study drug|All randomized participants who received at least one dose of study drug and have data for SBP|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2530203|NCT03405935|Secondary|Change From Baseline in CD4 Percentage at Week 96||Week 96|||||||
2530204|NCT03405935|Secondary|Change From Baseline in CD4 Percentage at Week 72||Week 72|||||||
2530205|NCT03405935|Secondary|Change From Baseline in CD4 Percentage at Week 48||Week 48|Participants in the Full Analysis Set with available data were analyzed.|||percentage of lymphocytes||Standard Deviation|Mean
2530206|NCT03405935|Secondary|Change From Baseline in CD4 Percentage at Week 24||Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of lymphocytes||Standard Deviation|Mean
2530207|NCT03405935|Secondary|Change From Baseline in CD4 Cell Count at Week 96||Week 96|||||||
2530208|NCT03405935|Secondary|Change From Baseline in CD4 Cell Count at Week 72||Week 72|||||||
2530209|NCT03405935|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Week 48|Participants in the Full Analysis Set with available data were analyzed.|||cells per µL||Standard Deviation|Mean
2530210|NCT03405935|Secondary|Change From Baseline in CD4 Cell Count at Week 24||Week 24|Participants in the Full Analysis Set with available data were analyzed.|||cells per µL||Standard Deviation|Mean
2530211|NCT03405935|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the FDA-Defined Snapshot Algorithm||Week 96|||||||
2530212|NCT03405935|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72 as Defined by the FDA-Defined Snapshot Algorithm||Week 72|||||||
2530213|NCT03405935|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA-Defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined timepoint within an allowed window of time, along with study drug discontinuation status.|Week 48|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2530214|NCT03405935|Secondary|Percentage of Participants Experiencing Adverse Events Through Week 96||First dose date Up to Week 96|||||||
2530215|NCT03405935|Secondary|Percentage of Participants Experiencing Adverse Events Through Week 72||First dose date Up to Week 72|||||||
2530216|NCT03405935|Secondary|Percentage of Participants Experiencing Adverse Events Through Week 48||First dose date Up to Week 48|Participants in the Safety Analysis Set were analyzed.|||percentage of participants|||Number
2530217|NCT03405935|Secondary|Percentage of Participants Experiencing Adverse Events Through Week 24||First dose date up to Week 24|The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2530218|NCT03405935|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the Food and Drug Administration (FDA)-Defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined timepoint within an allowed window of time, along with study drug discontinuation status.|Week 24|The Full Analysis Set (FAS) included all participants who were enrolled and received at least 1 dose of study drug; and did not have major protocol violations.|||percentage of participants|||Number
2530219|NCT03405818|Secondary|Percentage of Participants With Negative Fungal Culture of the Target Great Toenail (TGT) at Weeks 24 and 52||Week 24, 52|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||percentage of participants|||Number
2530220|NCT03405818|Secondary|Percentage of Participants With Mycological Cure of Target Great Toenail (TGT) at Week 24 and 52|Mycological cure was defined as negative mycology of the TGT. Negative mycology was defined as negative fungal culture and negative potassium hydroxide (KOH) wet mount. Participants with only one result for either fungal culture or KOH were excluded from this analysis.|Week 24, 52|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||percentage of participants|||Number
2530221|NCT03405818|Secondary|Percentage of Participants With Clinical Efficacy of Target Great Toenail (TGT) at Week 24 and 52|Clinical efficacy target great toenail (TGT) was defined as completely clear nail or almost clear nail.|Week 24, 52|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||percentage of participants|||Number
2530222|NCT03405818|Secondary|Percentage of Participants With Almost Complete Cure of Target Great Toenail (TGT) at Week 24 and 52|Almost complete cure was defined as almost clear nail and negative mycology (negative mycology was defined as negative fungal culture and negative KOH wet mount).|Week 24, 52|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||percentage of participants|||Number
2530223|NCT03405818|Secondary|Elimination Half-Life of Tavaborole|Elimination half-life (t1/2) was defined as the time required for the body to eliminate half of the drug than its original concentration.|Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29|"Pharmacokinetics (PK) population: all participants from the maximal use subgroup (aged between 12 to 16 years and 11 months with once daily application to all 10 toenails, including up to 2 millimeter [mm] of the surrounding skin) and had PK data available. Here, N signifies number of participants evaluable for this specified outcome measure."|||hour||Standard Deviation|Mean
2530224|NCT03405818|Secondary|Elimination Rate Constant of Tavaborole|Elimination rate constant was defined as the rate at which a drug was removed from the body.|Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29|"Pharmacokinetics (PK) population: all participants from the maximal use subgroup (aged between 12 to 16 years and 11 months with once daily application to all 10 toenails, including up to 2 millimeter [mm] of the surrounding skin) and had PK data available. Here, N signifies number of participants evaluable for this specified outcome measure."|||per hour||Standard Deviation|Mean
2530225|NCT03405818|Secondary|Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of Tavaborole||Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29|"Pharmacokinetics (PK) population: all participants from the maximal use subgroup (aged between 12 to 16 years and 11 months with once daily application to all 10 toenails, including up to 2 millimeter [mm] of the surrounding skin) and had PK data available. Here, N signifies number of participants evaluable for this specified outcome measure."|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
2530226|NCT03405818|Secondary|Area Under the Plasma Concentration-Time Curve From Hour Zero to Hour 24 (AUC24) of Tavaborole|AUC24 was defined as the area under the plasma concentration-time curve from hour 0 to hour 24. AUC24 was calculated using the linear trapezoidal rule.|Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29|"Pharmacokinetics (PK) population: all participants from the maximal use subgroup (aged between 12 to 16 years and 11 months with once daily application to all 10 toenails, including up to 2 millimeter [mm] of the surrounding skin) and had PK data available. Here, N signifies number of participants evaluable for this specified outcome measure."|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
2530227|NCT03405818|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Tavaborole||Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29|"Pharmacokinetics (PK) population: all participants from the maximal use subgroup (aged between 12 to 16 years and 11 months with once daily application to all 10 toenails, including up to 2 millimeter [mm] of the surrounding skin) and had PK data available. Here, N signifies number of participants evaluable for this specified outcome measure."|||hour||Full Range|Median
2530228|NCT03405818|Secondary|Maximum Observed Plasma Concentration (Cmax) of Tavaborole||Pre-dose, 4, 6, 8, 24 hours post-dose on Day 29|Pharmacokinetics (PK) population: all participants from the maximal use subgroup (aged between 12 to 16 years and 11 months with once daily application to all 10 toenails, including up to 2 millimeter [mm] of the surrounding skin) and had PK data available.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2530229|NCT03405818|Primary|Percentage of Participants With Complete Cure of Target Great Toenail (TGT) at Week 52|Complete cure was defined as completely clear nail, negative fungal culture and negative potassium hydroxide (KOH) wet mount.|Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||percentage of participants|||Number
2530230|NCT03405818|Primary|Change From Baseline in Vital Sign (Respiratory Rate) at Week 52|Respiratory rate was defined as the number of inspirations per minute.|Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||Breaths per minute||Standard Deviation|Mean
2530231|NCT03405818|Primary|Change From Baseline in Vital Sign (Respiratory Rate) at Week 24|Respiratory rate was defined as the number of inspirations per minute.|Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||Breaths per minute||Standard Deviation|Mean
2554593|NCT02756689|Secondary|Maximum Oxytocin Rate||Assessed from baseline to delivery, up to 3 days||||milliunits/min||Standard Deviation|Mean
2530232|NCT03405818|Primary|Change From Baseline in Vital Sign (Pulse Rate) at Week 52|Pulse rate was defined as the number of pulsations noted in a peripheral artery per minute after participant rested supine for 5 minutes.|Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||Beats per minute (bpm)||Standard Deviation|Mean
2530233|NCT03405818|Primary|Change From Baseline in Vital Sign (Pulse Rate) at Week 24|Pulse rate was defined as the number of pulsations noted in a peripheral artery per minute after participant rested supine for 5 minutes.|Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||Beats per minute (bpm)||Standard Deviation|Mean
2530234|NCT03405818|Primary|Change From Baseline in Vital Sign (Blood Pressure) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2530235|NCT03405818|Primary|Change From Baseline in Vital Sign (Blood Pressure) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2530236|NCT03405818|Primary|Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||millimole per liter (mmol/L)||Standard Deviation|Mean
2530237|NCT03405818|Primary|Change From Baseline in Chemistry Parameters (Potassium and Sodium) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||millimole per liter (mmol/L)||Standard Deviation|Mean
2530238|NCT03405818|Primary|Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2530239|NCT03405818|Primary|Change From Baseline in Chemistry Parameters (Bilirubin, Creatinine, Glucose [Non-fasting] and Urea Nitrogen) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2530240|NCT03405818|Primary|Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||gram per deciliter (g/dL)||Standard Deviation|Mean
2530241|NCT03405818|Primary|Change From Baseline in Chemistry Parameters (Albumin and Protein) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||gram per deciliter (g/dL)||Standard Deviation|Mean
2530242|NCT03405818|Primary|Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||International Unit per liter (IU/L)||Standard Deviation|Mean
2530243|NCT03405818|Primary|Change From Baseline in Chemistry Parameters (Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||International Unit per liter (IU/L)||Standard Deviation|Mean
2530244|NCT03405818|Primary|Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||10^9 cells per liter||Standard Deviation|Mean
2530245|NCT03405818|Primary|Change From Baseline in Hematology Parameters (Leukocytes and Platelets) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||10^9 cells per liter||Standard Deviation|Mean
2530246|NCT03405818|Primary|Change From Baseline in Hematology Parameters (Hemoglobin) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||gram per deciliter (g/dL)||Standard Deviation|Mean
2530247|NCT03405818|Primary|Change From Baseline in Hematology Parameters (Hemoglobin) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||gram per deciliter (g/dL)||Standard Deviation|Mean
2530248|NCT03405818|Primary|Change From Baseline in Hematology Parameter (Erythrocytes) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||10^12 cells per liter||Standard Deviation|Mean
2530249|NCT03405818|Primary|Change From Baseline in Hematology Parameter (Erythrocytes) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||10^12 cells per liter||Standard Deviation|Mean
2530250|NCT03405818|Primary|Change From Baseline in Hematology Parameter (Hematocrit) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||volume percentage of red blood cells||Standard Deviation|Mean
2530252|NCT03405818|Primary|Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 52||Baseline, Week 52|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||percentage of leukocytes||Standard Deviation|Mean
2530253|NCT03405818|Primary|Change From Baseline in Hematology Parameters (Leukocytes: Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Week 24||Baseline, Week 24|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||percentage of leukocytes||Standard Deviation|Mean
2530254|NCT03405818|Primary|Number of Participants With Adverse Events (AEs) By Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment by investigator and defined as: Mild = symptoms barely noticeable to the participant or does not make the participant uncomfortable; moderate = symptoms of a sufficient severity to make the participant uncomfortable; severe = symptoms of a sufficient severity to cause the participant severe discomfort.|Baseline up to 28 days after last dose of study drug (up to Week 52)|"Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment. Here, N signifies number of participants evaluable for this specified outcome measure."|||Participants|||Count of Participants
2530255|NCT03405818|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious AEs.|Baseline up to 28 days after last dose of study drug (up to Week 52)|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||Participants|||Count of Participants
2530256|NCT03405818|Primary|Number of Participants With Local Tolerability Reactions by Severity|Local tolerability reactions consisted of burning/stinging, induration/edema, oozing and crusting, pruritus, erythema, and scaling. Here 0 indicates None, 1 (Mild), 2 (Moderate) and 3 (severe). Grading details are as follows: Burning/Stinging (0: no stinging/burning, 1: slight warm, 2: definite warm, 3: hot); Induration/Edema (0: no elevation, 1: barely perceptible elevation, 2: clearly perceptible elevation but not extensive, 3: marked and extensive elevation); Oozing and Crusting (0: absent, 1: faint signs of oozing, 2: definite oozing, 3: marked and extensive oozing); Pruritus (0: no pruritus, 1: occasional, slight itching, 2: constant itching which is not disturbing sleep, 3: severe bothersome itching/scratching which is disturbing sleep); Erythema (0: no redness present, 1: faintly detectable erythema; very light pink, 2: dull red, 3: deep/dark red); Scaling (0: no scaling, 1: barely perceptible shedding, 2: obvious but not profuse scaling, 3: heavy scale production).|Baseline up to Week 52|Safety Population: all participants who received at least 1 confirmed dose of study drug and had at least 1 post-baseline safety assessment.|||Participants|||Count of Participants
2530257|NCT03405259|Primary|Change From Baseline Visual Analog Scale|Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline.|Within 5 minutes after treatment was applied|Twenty-two (22) subjects received product and completed the study.|||Units on a scale||Standard Deviation|Mean
2530258|NCT03405259|Primary|Change From Baseline Air Challenge|The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure.|Within 5 minutes after treatment was applied|Twenty-two (22) subjects received study product and completed the study.|||Units on a scale||Standard Deviation|Mean
2530259|NCT03404843|Secondary|Arterial Stiffness After Administration of Intervention|Arterial stiffness measured non-invasively using a SphygmoCor system after administration of saline (placebo) and fasudil. This is a randomized crossover design study, so participants will receive 1 treatment (saline or fasudil) on their first visit and the other treatment on their second visit.|Immediately following administration of intervention|All participants who completed both interventions (crossover design) with outcome data collected|||m/s||Standard Error|Mean
2530260|NCT03404843|Primary|Change in ATP Release to Exercise After Administration of Intervention|Venous plasma concentrations of ATP measured using a luminometer before and during continuous rhythmic handgrip exercise at a low, moderate, and high intensity workload (4 minutes at each workload for 12 minutes in total).|Within 4 hours after administration of intervention|All participants who completed both interventions (crossover design) with outcome data collected|||nmol/L||Standard Error|Mean
2530261|NCT03404843|Primary|Change in ATP Release to Hypoxia After Administration of Intervention|Venous plasma concentrations of ATP measured using a luminometer before and after 5 minutes of exposure to hypoxia (breathing a mix of low-oxygen gas and room air to achieve oxygen saturations of ~80%).|Within 4 hours after administration of intervention|All participants who completed both interventions (crossover design) with outcome data collected|||nmol/L||Standard Error|Mean
2530262|NCT03404843|Primary|Forearm Blood Flow Responses to Exercise After Administration of Intervention|Forearm blood flow measured using Doppler ultrasound before and during continuous rhythmic handgrip exercise at a low, moderate, and high intensity workload (4 minutes at each workload for 12 minutes in total).|Within 4 hours after administration of intervention|All participants who completed both interventions (crossover design) with outcome data collected|||mL/min||Standard Error|Mean
2530263|NCT03404843|Primary|Forearm Blood Flow Responses to Hypoxia After Administration of Intervention|Forearm blood flow measured using Doppler ultrasound before and after 5 minutes of exposure to hypoxia (breathing a mix of low-oxygen gas and room air to achieve oxygen saturations of ~80%).|Within 4 hours after administration of intervention|All participants who completed both interventions (crossover design) with outcome data collected|||mL/min||Standard Error|Mean
2530264|NCT03404206|Secondary|Total Pain Relief (TOTPAR)|Pain relief was measured using Categorical Pain Relief Rating Scale (0 = No relief, 1 = a little relief, 2 = some relief, 3 = a lot of relief, 4 = complete relief). Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.|Up to 24 hours|Per-protocol population|||Scores on a scale * hours||Standard Deviation|Mean
2530265|NCT03404206|Secondary|Sum of Pain Intensity Difference (SPID)|Pain intensity was measured using Numerical Rating Scale (from 0 to 10: 0 = no pain, 10 = worst possible pain). For each postdose time point, pain intensity differences (PIDs) were derived by subtracting the pain intensity at the postdose time point from the baseline intensity score (baseline score - post-baseline score). A positive difference was indicative of improvement. Time-weighted sum of pain intensity differences (SPIDs) were calculated by multiplying the PID score at each postdose time point by the duration (in hours) since the preceding time point and then summing these values.|Up to 24 hours|Per-protocol population|||Scores on a scale * hours||Standard Deviation|Mean
2530266|NCT03404206|Primary|Time to First Use of Rescue Medication|Time to first use of rescue medication was estimated using Kaplan-Meier method. If a subject did not take the rescue medication during the treatment period, (s)he was censored at the time of last assessment.|Up to 24 hours|Per-protocol population|||hours|||Number
2530267|NCT03404167|Secondary|Occurrence of Treatment-emergent Serious Adverse Events|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect.|From study product administration (Day 1) to Day 8|Any participants who received study product.|||Participants|||Count of Participants
2530268|NCT03404167|Secondary|Occurrence of Unsolicited Treatment-emergent Adverse Events|Adverse events are defined as any untoward medical occurrence regardless of its causal relationship to the study treatment.|From study product administration (Day 1) to Day 8|Any participants who received study product|||Participants|||Count of Participants
2530269|NCT03404167|Secondary|Changes From Baseline for Protein Via Dipstick|Urine for the clinical laboratory test was collected on Day -1 and Day 4. The results for protein were reported in categorical results. The possibilities were negative, trace, 1+, 2+, and 3+.|From Day -1 through Day 4|Any participants who received study product and had urine collected on Day -1 and Day 4.|||Participants|||Count of Participants
2530270|NCT03404167|Secondary|Changes From Baseline for Glucose Via Dipstick|Urine for the clinical laboratory test was collected on Day -1 and Day 4. The results for glucose were reported in categorical results. The possibilities were negative, trace, 1+, 2+, and 3+.|From Day -1 through Day 4|Any participants who received study product and had urine collected on Day -1 and Day 4.|||Participants|||Count of Participants
2530271|NCT03404167|Secondary|Changes From Baseline for Occult Blood Via Dipstick|Urine for the clinical laboratory test was collected on Day -1 and Day 4. The results for occult blood were reported in categorical results. The possibilities were negative, trace, 1+, 2+, and 3+.|From Day -1 through Day 4|Any participants who received study product and had urine collected on Day -1 and Day 4.|||participants|||Number
2530272|NCT03404167|Secondary|Changes From Baseline in ECG: Ventricular Rate|Change from baseline in ECG Ventricular Rate calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, and 72 h after dosing.|From Day -1 through Day 4|Any participants who received study product and had an ECG collected on Day -1 and at least one time point post dose.|||beats per minute||Standard Deviation|Mean
2530273|NCT03404167|Secondary|Changes From Baseline in ECG: RR Interval (Interval From the Peak of the R Wave of a QRS Complex to the Peak of the R Wave of the Next QRS Complex)|Change from baseline in ECG RR Interval calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, and 72 h after dosing.|From Day -1 through Day 4|Any participants who received study product and had an ECG collected on Day -1 and at least one time point post dose.|||msec||Standard Deviation|Mean
2530274|NCT03404167|Secondary|Changes From Baseline in ECG: QT Interval (Interval From Onset of the Q-wave to the End of the T-wave)|Change from baseline in ECG QT Interval calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, and 72 h after dosing.|From Day -1 through Day 4|Any participants who received study product and had an ECG collected on Day -1 and at least one time point post dose.|||msec||Standard Deviation|Mean
2530275|NCT03404167|Secondary|Changes From Baseline in ECG: QTcF Interval (QT Interval Corrected by Fridericia's Formula)|Change from baseline in ECG QTcF Interval calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, and 72 h after dosing.|From Day -1 through Day 4|Any participants who received study product and had an ECG collected on Day -1 and at least one time point post dose.|||msec||Standard Deviation|Mean
2530276|NCT03404167|Secondary|Changes From Baseline in ECG: QRS Duration (Time From the Start of the Q-wave to the End of the S-wave)|Change from baseline in ECG QRS Duration calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, and 72 h after dosing.|From Day -1 through Day 4|Any participants who received study product and had an ECG collected on Day -1 and at least one time point post dose.|||msec||Standard Deviation|Mean
2530277|NCT03404167|Secondary|Changes From Baseline in ECG: PR Interval (Interval From Onset of P-wave to the Onset of the QRS Complex)|Change from baseline in ECG PR Interval calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, 4 h, and 72 h after dosing.|From Day -1 through Day 4|Any participants who received study product and had an ECG collected on Day -1 and at least one time point post dose.|||msec||Standard Deviation|Mean
2530538|NCT03383627|Primary|Mean Number of Hypoglycemic Events Per Participant.|Total number of hypoglycemic events per subject will be calculated during the study period. Mean number of events per subject will be analyzed.|14 Days||||Hypoglycemic events||Standard Deviation|Mean
2530278|NCT03404167|Secondary|Changes From Baseline for Respiratory Rate|Change from baseline in respiratory rate calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.|From Day -1 through Day 8|Any participants who received study product and had vital signs collected on Day -1 and at least one time point post dose.|||Breaths per minute||Standard Deviation|Mean
2530279|NCT03404167|Secondary|Changes From Baseline in Pulse Rate|Change from baseline in pulse rate calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.|From Day -1 through Day 8|Any participants who received study product and had vital signs collected on Day -1 and at least one time point post dose.|||Beats per minute||Standard Deviation|Mean
2530280|NCT03404167|Secondary|Changes From Baseline in Oral Temperature|Change from baseline in temperature calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.|From Day -1 through Day 8|Any participants who received study product and had vital signs collected on Day -1 and at least one time point post dose.|||Degress C||Standard Deviation|Mean
2530281|NCT03404167|Secondary|Changes From Baseline for Blood Pressure - Diastolic|Change from baseline in diastolic blood pressure calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.|From Day -1 through Day 8|Any participants who received study product and had vital signs collected on Day -1 and at least one time point post dose.|||mmHg||Standard Deviation|Mean
2530282|NCT03404167|Secondary|Changes From Baseline for Blood Pressure - Systolic|Change from baseline in systolic blood pressure calculated by subtracting the baseline (pre-dose) measurement from the post-dose measurement. Post-dose measurements were taken 1 h, 2 h, and 4 h after dosing, and on Day 2, Day 3, Day 4, and Day 8. Vital signs were measured after supine for at least 10 minutes.|From Day -1 through Day 8|Any participants who received study product and had vital signs collected on Day -1 and at least one time point post dose.|||mmHg||Standard Deviation|Mean
2530283|NCT03404167|Secondary|Changes From Baseline for Sodium, Potassium, Chloride and Bicarbonate|Change from baseline calculated by subtracting the Day -1 (baseline) serum chemistry measurement from the Day 4 serum chemistry measurement. Serum chemistry tests for this outcome measure included sodium, potassium, chloride, and bicarbonate.|From Day -1 through Day 4|Any participants who received study product and had safety labs collected on Day -1 and Day 4|||mmol/L||Standard Deviation|Mean
2530284|NCT03404167|Secondary|Change From Baseline for Blood Urea Nitrogen (BUN), Serum Creatinine, Glucose (Fasting at Least 4h), Magnesium, Total and Direct Bilirubin|Change from baseline calculated by subtracting the Day -1 (baseline) serum chemistry measurement from the Day 4 serum chemistry measurement. Serum chemistry tests for this outcome measure included BUN, creatinine, fasting glucose, magnesium, total bilirubin, and direct bilirubin.|From Day -1 through Day 4|Any participants who received study product and had safety labs collected on Days -1 and 4|||mg/dL||Standard Deviation|Mean
2530285|NCT03404167|Secondary|Change From Baseline for Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)|Change from baseline calculated by subtracting the Day -1 (baseline) AP, ALT, or AST measurement from the Day 4 AP, ALT, or AST measurement.|From Day -1 through Day 4|Any participants who received study product and had safety labs collected on Days -1 and 4|||U/L||Standard Deviation|Mean
2530286|NCT03404167|Secondary|Changes From Baseline for Albumin and Total Protein|Change from baseline calculated by subtracting the Day -1 (baseline) albumin or total protein measurement from the Day 4 albumin or total protein measurement.|From Day -1 through Day 4|Any participants who received study product and had safety labs collected on Days -1 and 4|||g/dL||Standard Deviation|Mean
2530287|NCT03404167|Secondary|Changes From Baseline Red Blood Cell Count|Change from baseline calculated by subtracting the Day -1 (baseline) red blood cell count measurement from the Day 4 red blood cell count measurement.|From Day -1 through Day 4|Any participants who received study product and had safety labs collected on Days -1 and 4|||10^12/L||Standard Deviation|Mean
2530288|NCT03404167|Secondary|Changes From Baseline Hemoglobin|Change from baseline calculated by subtracting the Day -1 (baseline) hemoglobin measurement from the Day 4 hemoglobin measurement.|From Day -1 through Day 4|Any participants who received study product and had safety labs collected on Days -1 and 4|||g/dL||Standard Deviation|Mean
2530289|NCT03404167|Secondary|Changes From Baseline Hematocrit|Change from baseline calculated by subtracting the Day -1 (baseline) hematocrit measurement from the Day 4 hematocrit measurement.|From Day -1 through Day 4|Any participants who received study product and had safety labs collected on Days -1 and 4|||percentage||Standard Deviation|Mean
2530290|NCT03404167|Secondary|Changes From Baseline for White Blood Cells With Differentials and Platelets|Change from baseline calculated by subtracting the Day -1 (baseline) hematology measurement from the Day 4 hematology measurement. Hematology parameters included white blood cell count, differential (absolute counts of neutrophils, lymphocytes, monocytes, eosinophils, and basophils), and platelet count.|From Day -1 through Day 4|Any participants who received study product and had safety labs collected on Days -1 and 4|||10^9/L||Standard Deviation|Mean
2530291|NCT03404167|Primary|Terminal Elimination Half-life (t1/2) of Zoliflodacin|The apparent terminal elimination half-life (t1/2) was defined as the time required for the drug concentration to decrease by a factor of one-half in the terminal phase computed from concentrations that were measured using a validated HPLC-MS/MS method.|From Day 1 to Day 4|The analysis population consists of all eight participants.|||hour||Standard Deviation|Mean
2530292|NCT03404167|Primary|Elimination Rate Constant (Ke) of Zoliflodacin|The terminal phase elimination rate constant (Ke) was defined as the first-order rate constant describing the rate of decrease of drug concentration in the terminal phase (defined as the terminal region of the PK curve where drug concentration follows first-order elimination kinetics) computed from concentrations that were measured using a validated HPLC-MS/MS method.|From Day 1 to Day 4|The analysis population consists of all eight participants.|||1/hour||Standard Deviation|Mean
2530294|NCT03404167|Primary|Apparent Volume of Distribution (Vz/F) of Zoliflodacin|Apparent volume of distribution during terminal phase (Vz/F) after non-intravenous administration was calculated as (CL/F)/ Ke computed from concentrations that were measured using a validated HPLC-MS/MS method.|From Day 1 to Day 4|The analysis population consists of all eight participants.|||Liter||Standard Deviation|Mean
2530295|NCT03404167|Primary|Area Under the Concentration Time-curve From Time Zero to the Last Concentration Above the Lower Limit of Quantitation (AUC(0-last)) for Zoliflodacin|AUC(0-last) was defined as the area under the concentration-time curve from dosing (time 0) to the time of the last measured concentration computed from concentrations that were measured using a validated HPLC-MS/MS method.|From Day 1 to Day 4|The analysis population consists of all eight participants.|||h x ng/mL||Standard Deviation|Mean
2530296|NCT03404167|Primary|Area Under the Concentration Time-curve From Time Zero to Infinity (AUC(0-infinity)) for Zoliflodacin|AUC(0-8) was defined as the total area under the concentration-time curve from dosing (time 0) taken to the limit as the end time becomes arbitrarily large. AUC(0-8) and was calculated by adding AUC(0-last) to an extrapolated value equal to the last measured concentration greater than the lower limit of quantification of the bioanalytical assay divided by the terminal phase elimination rate constant (Ke) computed from concentrations that were measured using a validated HPLC-MS/MS method.|From Day 1 to Day 4|The analysis population consists of all eight participants.|||h x ng/mL||Standard Deviation|Mean
2530297|NCT03404167|Primary|Time of Maximum Observed Concentration (Tmax) of Zoliflodacin|Tmax was defined as the time at which the maximum concentration (Cmax) occurs in plasma computed from concentrations that were measured using a validated HPLC-MS/MS method.|From Day 1 to Day 4|The analysis population consists of all eight participants.|||hour||Standard Deviation|Mean
2530298|NCT03404167|Primary|Maximum Observed Concentration (Cmax) of Zoliflodacin|Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations computed from concentrations that were measured using a validated HPLC-MS/MS method.|From Day 1 to Day 4|The analysis population consists of all eight participants.|||ng/mL||Standard Deviation|Mean
2530299|NCT03403712|Secondary|Overall Proportion of Patients With NIDL Based on FLIE Scores for Cycles 1|"Proportion (including two-sided 95% CI using Wilson score method) of patients with NIDL based on FLIE scores (overall, by domain, and by individual item) are summarized by treatment group. NIDL was defined as a score greater than 108 points, 54 points, and 6 points for total FLIE score, domain score, and single item score, respectively. Differences between treatment groups for total FLIE score and domain scores (nausea and vomiting) were presented with two-sided 95% CIs using the CMH method adjusted for region and age class strata and also using Newcombe-Wilson's method without strata adjustment.~No Impact on Daily Life (NIDL) Based on Functional Living Index-Emesis (FLIE) Scores. The FLIE is a nausea and vomiting specific self report instrument comprised of two domains (nausea and vomiting) with nine identical items in each domain"|cycle 1||||percentage of participants||95% Confidence Interval|Number
2530300|NCT03403712|Secondary|Complete Response in Cycle 1 During the Overall Phase|defined as no emetic episodes [vomit or retch] and no rescue medication|0-120 hours after the start of AC chemotherapy||||Participants|||Count of Participants
2530301|NCT03403712|Secondary|Complete Response in Cycle 1 During the Delayed Phase|defined as no emetic episodes [vomit or retch] and no rescue medication|120 hour after the start of AC chemotherapy administration||||Participants|||Count of Participants
2530302|NCT03403712|Secondary|Complete Response in Cycle 1 During the Acute Phase|defined as no emetic episodes [vomit or retch] and no rescue medication|24 hours after the start of AC chemotherapy administration||||Participants|||Count of Participants
2530303|NCT03403712|Primary|Number of Participants With Study-Drug-Related TEAEs Reported for ≥2% of Patients in Either Treatment Group Throughout the Study||At the end of Cycle 4 (each cycle is 21 days)||||Participants|||Count of Participants
2530304|NCT03403712|Primary|Number of Participants With Severe (i.e., CTCAE Grade ≥3) TEAEs Reported for ≥2% of Patients in Either Treatment Group and Overall Throughout the Study||At the end of Cycle 4 (each cycle is 21 days)||||Participants|||Count of Participants
2530305|NCT03403712|Primary|Number of Participants With Treatment-emergent AEs All Cycles||At the end of Cycle 4 (each cycle is 21 days)||||Participants|||Count of Participants
2530306|NCT03403712|Primary|Number of Participants With Treatment-emergent AEs at Cycle 1||At the end of Cycle 1 (each cycle is 21 days)||||Participants|||Count of Participants
2530307|NCT03403504|Secondary|Number of AEs Related to Physical Examination|Physical examination was conducted at screening, and on Day -1, Day 4 in each Period.|up to 35 days||||AEs related to physical examinations|||Number
2530308|NCT03403504|Secondary|Number of Lab Tests With Clinical Significance|Clinical laboratory data (hematology, blood chemistry, and urinalysis) to be summarized on the rate of lower than, within, and higher than the reference range values from baseline to end of study.|up to 35 days||||lab tests with clinical significance|||Number
2530309|NCT03403504|Secondary|Number of AEs Related to ECGs|Twelve-lead ECG was conducted at screening and on Day 4 of Period 2.|up to 35 days||||AEs related to ECGs|||Number
2530310|NCT03403504|Secondary|Number of AEs Related to Vital Signs|Vital sign parameters( systolic blood pressure, diastolic blood pressure, pulse rate, respiration rate, and axillary temperature)to be summarised on the rate of lower than, within, and higher than the reference range values from baseline to end of study.|up to 35 days||||AEs of vital signs related|||Number
2530311|NCT03403504|Secondary|Adverse Events of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg, When Given to Chinese Subjects With Chronic Pain in a Fasted State|An overall summary of the number and percentage of Adverse Events will be provided for each treatment groups to assess the safety of OTR tablet 10 mg and OXYCONTIN tablet 10 mg.|up to 35 days||||AEs|||Number
2530312|NCT03403504|Primary|AUCINF of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted State|The analysis was for PK parameters AUCINF for analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) was used to compare the test and the reference treatments.|up to 32 hours||||ng*h/ml||90% Confidence Interval|Mean
2530313|NCT03403504|Primary|AUCt of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted State|The analysis was for PK parameters AUCt of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments.|up to 32 hours||||ng*h/ml||90% Confidence Interval|Mean
2530314|NCT03403504|Primary|Cmax of OTR Tablet 10 mg and OXYCONTIN Tablet 10 mg in a Fasted State|The analysis was for PK parameters Cmax of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments.|up to 32 hours||||ng/ml||90% Confidence Interval|Mean
2530315|NCT03403036|Secondary|Number of Adverse Events|Number of adverse events as a measure of safety|16 weeks||||events|||Number
2530316|NCT03403036|Secondary|Number of Participants With Psoriasis Area and Severity Index (PASI) Score Improvement|PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). Number of participants with 75%, 90%, and 100% reduction in the PASI score, respectively, PASI-75, PASI-90, and PASI-100 who completed the trial at week 16.|16 weeks||||Participants|||Count of Participants
2530317|NCT03403036|Primary|Number of Patients With Physician's Global Assessment (sPGA) Score 0 or 1|"Number of patients achieving a score of 0-clear or 1-almost clear in the sPGA score after 16 weeks of treatment to measure efficacy.~Static Physician Global Assessment (sPGA) - 3 categories induration, erythema, and scaling, scored 0-4, these 3 categories averaged giving total score from 0-4, with higher score indicating more symptoms."|16 weeks||||Participants|||Count of Participants
2530318|NCT03402932|Secondary|Auditory Working Memory Performance|Older individuals were presented with lists of words and instructed to repeat them back. After each word list, they had to recall the words.|The outcome measure will be assessed immediately after the test.||||percentage of correct recall||Standard Deviation|Mean
2530319|NCT03402932|Primary|Cognitive Screening Results (Montreal Cognitive Assessment)|"The cognitive screening test of Montreal Cognitive Assessment (MoCA) was administered to 4 groups with different administration method conditions (see arms/groups table).~MoCA is s standardized cognitive screening tool for mild cognitive impairment and dementia. The total score was used as outcome measure of this study and this score ranges from 0-30, with higher score being better performance."|The outcome measure was assessed immediately after the test. This applies to both conditions for all the arms.||||score on a scale||Standard Deviation|Mean
2530320|NCT03402893|Secondary|Post-Inflammatory Hyperpigmentation (PIH) Distribution|This measure as assessed by the Investigator seeks to quantify the extent to which post-inflammatory hyperpigmentation is distributed across the face, wherein 0= No PIH, 1=1-10% of the face affected, 2=11-20%, 3=21-30%, 4=31-40%, 5=41-50%, and 6=More than 50% of the face. Lower numbers reflect less severe disease.|baseline, Week 4, week 8, week 16||||Participants|||Count of Participants
2530321|NCT03402893|Secondary|Percent Change in Total Lesion Count|The Investigator will count the number of facial inflammatory and non-inflammatory acne lesions at each study visit. These include papules, pustules, nodules, and open and closed comedones.|week 4, Week 8, Week 16||||percent change||Standard Deviation|Mean
2530322|NCT03402893|Secondary|Percent Change in Non-inflammatory Lesion Count|The Investigator will count the number of facial non-inflammatory acne lesions at each study visit. these include open and closed comedones.|Week 4, Week 8, Week 16||||percent change||Standard Deviation|Mean
2530323|NCT03402893|Secondary|Percent Change in Inflammatory Lesions|The Investigator will count the number of facial (from hairline to mandibular line) inflammatory acne lesions at each study visit. Inflammatory lesions include papules, pustules and nodules.|Week 4, Week 8, Week 16||||percent change||Standard Deviation|Mean
2530324|NCT03402893|Primary|Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation|Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for severity of post inflammatory hyperpigmentation; the IGA scale of post-inflammatory hyperpigmentation reflects the Investigator's assessment of the severity of a subject's hyperpigmentation on a scale from 0 to 6 with 0 = None, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = moderately Severe, 5 = Severe, 6 = Very severe Each of these gradations is based upon the investigator's impression|Week 4, Week 8, Week 16||||Participants|||Count of Participants
2530325|NCT03402893|Primary|Investigator Global Assessment Scale for Severity of Facial Acne|Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for facial acne; the IGA scale for acne reflects the Investigator's assessment of the severity of a subject's acne on a scale from 0 to 5 with 0 = Clear Skin, 1 = Almost Clear, 2 = Mild, 3 = Moderate severity, 4 = Severe, 5 = Very Severe Each of these gradations is based upon a lesion count by the Investigator.|Week 4, Week 8, Week 16||||Participants|||Count of Participants
2530326|NCT03402750|Secondary|Intervention Acceptance|All participants will be asked one question about the acceptability of the intervention program. Responses for acceptability items will be recorded on a 10-point scale (1, very unsatisfactory - 10, very satisfactory). Dichotomized due to extreme skew. Intervention acceptance will be reported as the number of participants that provides a score of 1 and higher.|Day 30|All participants completing follow-up interview. Not all participants completed the questionnaire.|||Participants|||Count of Participants
2530327|NCT03402750|Secondary|Number of Participants That Received Their Medications Prior to Discharge.|The program's feasibility will be evaluated by tracking whether medications can be successfully delivered (i.e., before discharge) to patients in the Meds to Beds condition. This measure will be evaluated as a proportion within the intervention condition.|Day 0|Patients in Standard Care arm could receive delivery of medications, contrary to intentions.|||Participants|||Count of Participants
2530328|NCT03402750|Secondary|Physical Health as Assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Questionnaire|Physical health is measured using the 10 item PROMIS questionnaire. Responses are recorded along a 5-point Likert scale with a total score ranging from 10-50. A higher score indicates better physical health.|Baseline and Day 30|Interviews completed at follow-up and baseline. Not all participants completed the PROMIS questionnaire at the 30-day follow up visit.|||score on a scale||Standard Deviation|Mean
2530329|NCT03402750|Primary|Pharmacy Refill Adherence to Medication|Medication adherence will be reported as the number of participants that completed their expected pharmacy refill. Standard Care participants are expected to complete one initial fill and one refill. Meds to Beds participants are expected to complete one pharmacy refill as the initial fill is handed upon discharge.|Day 30|Data on electronic medical record for refills of heart failure medications were only available for 10 participants in Meds to Beds and 11 in Standard Care.|||Participants|||Count of Participants
2530330|NCT03402750|Primary|Adherence to Medication|Adherence to medication will be reported as the number of participants that scores 12 and lower in a self-reported Adherence to Refills and Medications Scale (ARMS) Questionnaire. The questionnaire has 12 items with each item being recorded on a four-point Likert scale. The total score ranges from 12-48 with the lower score indicating better adherence.|Day 30|4 participants in each condition did not complete this measure.|||Participants|||Count of Participants
2530331|NCT03401671|Secondary|Number of Participants Who Developed Antidrug Antibodies to Lanadelumab at Specified Time Points|Plasma samples were analyzed for presence of antidrug antibodies to lanadelumab. Participants who show positive results for lanadelumab antibodies were reported.|Day 1, 14, 28, 56, and 112 (End of Study/Early Termination [EOS/ET])|Safety analysis set included all participants who received at least 1 dose of lanadelumab.|||Participants|||Count of Participants
2530332|NCT03401671|Secondary|Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as an Adverse Event|Twelve-lead ECG will be performed after 5 minutes of rest in the supine position. Any change in ECG assessments which are deemed clinically significant by the investigator are to be reported as AE.|From start of study drug administration up to follow-up (up to 115 days)|Safety analysis set includes all participants who received at least 1 dose of Lanadelumab.|||Participants|||Count of Participants
2530333|NCT03401671|Secondary|Number of Participants With Clinically Significant Change in Vital Signs Reported as an Adverse Event|Vital sign assessments include blood pressure, pulse rate and body temperature. Any changes from baseline in vital signs which are deemed clinically significant by the investigator are to be recorded as an AE.|From start of study drug administration up to follow-up (up to 115 days)|Safety analysis set included all participants who received at least 1 dose of Lanadelumab.|||Participants|||Count of Participants
2530334|NCT03401671|Secondary|Number of Participants With Clinically Significant Change in Clinical Laboratory Results Reported as an Adverse Event|Clinical laboratory assessments include hematology, clinical chemistry, coagulation and urinalysis. The investigator will assess out-of-range clinical laboratory values for clinical significance, to indicate whether or not the values are clinically significant. Any changes from baseline in clinical laboratory results which are deemed clinically significant by the investigator are to be recorded as an AE.|From start of study drug administration up to follow-up (up to 115 days)|Safety analysis set included all participants who received at least 1 dose of Lanadelumab.|||Participants|||Count of Participants
2530335|NCT03401671|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on Severity, Seriousness and Causality|An adverse event (AE) is any untoward medical occurrence in a clinical investigation participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs are defined as AEs with onset at the time of or following the first exposure to study drug, or medical conditions present prior to the start of study drug but increasing in severity or relationship at the time of or following the start of treatment, up to the last follow-up visit. Severity of an AE is determined by following definitions: Mild: An event that does not generally interfere with usual activities of daily living; Moderate: An event that interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participants; Severe: An AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.|From start of study drug administration up to follow-up (up to 115 days)|Safety analysis set included all participants who received at least 1 dose of Lanadelumab.|||Participants|||Count of Participants
2530336|NCT03401671|Primary|Body-weight Adjusted Apparent Volume of Distribution (Vz/F) of Lanadelumab|Body-weight adjusted Vz/F of Lanadelumab was presented.Geometric mean and geometric coefficient of variation percent (CV%) was presented.|Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose|PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.|||liter per kilogram (L/kg)||Geometric Coefficient of Variation|Geometric Mean
2530337|NCT03401671|Primary|Body-weight Adjusted Apparent Clearance (CL/F) of Lanadelumab|Body-weight adjusted CL/F of Lanadelumab was presented.Geometric mean and geometric coefficient of variation percent (CV%) was presented.|Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose|PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.|||liter per day per kilogram (L/day/kg)||Geometric Coefficient of Variation|Geometric Mean
2530338|NCT03401671|Primary|Body-weight Adjusted Maximum Observed Plasma Concentration (Cmax) of Lanadelumab|Body-weight adjusted Cmax of Lanadelumab was presented.Geometric mean and geometric coefficient of variation percent (CV%) was presented.|Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose|PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.|||microgram per milliliter per kilogram||Full Range|Median
2530339|NCT03401671|Primary|Body-weight Adjusted Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) in Plasma of Lanadelumab|Body-weight adjusted AUC(0-infinity) of Lanadelumab was presented. Geometric mean and geometric coefficient of variation percent (CV%) was presented.|Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose|PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.|||day*ug/mL/kg||Geometric Coefficient of Variation|Geometric Mean
2530340|NCT03401671|Primary|Body-weight Adjusted Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) in Plasma of Lanadelumab|Body-weight adjusted AUC(0-last) of Lanadelumab was presented. Geometric mean and geometric coefficient of variation percent (CV%) was presented.|Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose|PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.|||day*ug/mL/kg||Geometric Coefficient of Variation|Geometric Mean
2530341|NCT03401671|Primary|Apparent Volume of Distribution (Vz/F) of Lanadelumab|Vz/F of Lanadelumab was presented.Geometric mean and geometric coefficient of variation percent (CV%) was presented.|Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose|PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.|||liter||Geometric Coefficient of Variation|Geometric Mean
2530342|NCT03401671|Primary|Apparent Clearance (CL/F) of Lanadelumab|CL/F of Lanadelumab was presented.Geometric mean and geometric coefficient of variation percent (CV%) was presented.|Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose|PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.|||liter per day||Geometric Coefficient of Variation|Geometric Mean
2530343|NCT03401671|Primary|Terminal Half-life (t12) of Lanadelumab|t1/2 of Lanadelumab was presented.|Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose|PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.|||day||Full Range|Median
2530344|NCT03401671|Primary|Terminal Elimination Rate Constant (Lambda z) for Lanadelumab|Lambda z of Lanadelumab was presented.Geometric mean and geometric coefficient of variation percent (CV%) was presented.|Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose|PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.|||per day||Geometric Coefficient of Variation|Geometric Mean
2530345|NCT03401671|Primary|Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Lanadelumab|AUC(0-infinity) of Lanadelumab was presented.Geometric mean and geometric coefficient of variation percent (CV%) was presented.|Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose|PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.|||day*microgram per milliliter(day* ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2530346|NCT03401671|Primary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) in Plasma of Lanadelumab|AUC(0-last) of Lanadelumab was presented. Geometric mean and geometric coefficient of variation percent (CV%) was presented.|Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose|PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.|||day*microgram per milliliter(day*ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2530347|NCT03401671|Primary|Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of Lanadelumab|Tmax of Lanadelumab was presented.|Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose|PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.|||day||Full Range|Median
2530348|NCT03401671|Primary|Maximum Observed Plasma Concentration (Cmax) of Lanadelumab|Cmax is the maximum observed plasma concentration of Lanadelumab was presented. Geometric mean and geometric coefficient of variation percent (CV%) was presented.|Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose|Pharmacokinetic (PK) set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value.|||microgram per milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2530349|NCT03400787|Secondary|Responder Rate|Responder Rate at 7 days, 30 days, and 6, 12, 18 and 24 months will be assessed|7 days, 30 days, and 6, 12, 18 and 24 months.|||||||
2530350|NCT03400787|Primary|NOSE Responder Rate|The primary endpoint of the study is the NOSE Responder Rate, assessed 3 months post-procedure in the per-protocol population of the Latera and Sham arms. The Nasal Obstruction Symptom Evaluation (NOSE) is a validated patient-reported outcome assessment of 5 questions relating to nasal obstruction (congestion, obstruction, trouble breathing through the nose, trouble sleeping, unable to breath through the nose during exercise/exertion. Each question is rated on a Likert scale of 0 (no problem) to 4 (severe problem). The sum of the scores is multiplied by 5 to result in a total score that ranges from 0 to 100. NOSE scores can also be categorized as mild (5-25), moderate (30-50), severe (55-75), and extreme (80-100). A NOSE responder is defined as a participant with at least 1 NOSE class improvement or at least 20% total NOSE score reduction.|3 months postprocedure.||||Participants|||Count of Participants
2530351|NCT03400475|Secondary|Probing Depth Level (Averaged Over 6 Sites) at 1 Week|"Depth will be measured by a calibrated periodontal probe at 6 different locations, Mesiobuccal, Mid Buccal, Distobuccal, Disto Lingual, Mid Lingual and Mesio Lingual. The longitudinal course will be characterized with respect to the categorical outcome, presence of any bleeding on probing, with initial emphasis being placed upon transition approaches, with specific attention given to shifts from clinically unacceptable to clinically acceptable designations.~probing depth is considered variable from one person to the other however a decrease or a shallower probing depth overtime is gererally seen as an improvement , thus any decrease in probing depth would be seen as signs of healing."|1 week||||participants|||Number
2530352|NCT03400475|Secondary|Probing Depth Level (Averaged Over 6 Sites) at 24 Hours|"Depth will be measured by a calibrated periodontal probe at 6 different locations, Mesiobuccal, Mid Buccal, Distobuccal, Disto Lingual, Mid Lingual and Mesio Lingual. The longitudinal course will be characterized with respect to the categorical outcome, presence of any bleeding on probing, with initial emphasis being placed upon transition approaches, with specific attention given to shifts from clinically unacceptable to clinically acceptable designations.~probing depth is considered variable from one person to the other however a decrease or a shallower probing depth overtime is gererally seen as an improvement , thus any decrease in probing depth would be seen as signs of healing."|24 hours||||participants|||Number
2530353|NCT03400475|Secondary|Probing Depth Level (Averaged Over 6 Sites) at Baseline|"Depth will be measured by a calibrated periodontal probe at 6 different locations, Mesiobuccal, Mid Buccal, Distobuccal, Disto Lingual, Mid Lingual and Mesio Lingual. The longitudinal course will be characterized with respect to the categorical outcome, presence of any bleeding on probing, with initial emphasis being placed upon transition approaches, with specific attention given to shifts from clinically unacceptable to clinically acceptable designations.~probing depth is considered variable from one person to the other however a decrease or a shallower probing depth overtime is gererally seen as an improvement , thus any decrease in probing depth would be seen as signs of healing."|Baseline||||participants|||Number
2530370|NCT03400449|Secondary|Knowledge Scores|Mean total correct answer (score) to 7 multiple-choice contraceptive knowledge questions. Total possible score is 0-7, with 7 representing 100% correct answers. Score measured after completion of the knowledge questionnaire, on average less than one hour, before (pre) and after (post) counseling.|One hour||||score on a scale||Standard Deviation|Mean
2530354|NCT03400475|Secondary|Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 1 Week|"Using the Gingival index by Loe and Sillness 1963, the inflammatory state of the Buccal, Lingual, Mesial and Distal Surfaces of the gingiva will be scored using the following score system:~0= normal gingival without signs of inflammation, no inflammation, no bleeding~minor inflammation , slight discoloration, minor surface alterations, no bleeding~moderate inflammation, redness, swelling, bleeding upon probing and under pressure~strong inflammation, strong redness and swelling, tendency toward spontaneous bleeding, ulcerations After a score is given to each site the scores are summed together and divided by 4 to reach an overall score."|1 week||||participants|||Number
2530355|NCT03400475|Secondary|Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at 24 Hours|"Using the Gingival index by Loe and Sillness 1963, the inflammatory state of the Buccal, Lingual, Mesial and Distal Surfaces of the gingiva will be scored using the following score system:~0= normal gingival without signs of inflammation, no inflammation, no bleeding~minor inflammation , slight discoloration, minor surface alterations, no bleeding~moderate inflammation, redness, swelling, bleeding upon probing and under pressure~strong inflammation, strong redness and swelling, tendency toward spontaneous bleeding, ulcerations After a score is given to each site the scores are summed together and divided by 4 to reach an overall score."|24 hours||||participants|||Number
2530356|NCT03400475|Secondary|Gingival Index Level (Derived From an Average Over the 4 Implant Sites) at Baseline|"Using the Gingival index by Loe and Sillness 1963, the inflammatory state of the Buccal, Lingual, Mesial and Distal Surfaces of the gingiva will be scored using the following score system:~0= normal gingival without signs of inflammation, no inflammation, no bleeding~minor inflammation , slight discoloration, minor surface alterations, no bleeding~moderate inflammation, redness, swelling, bleeding upon probing and under pressure~strong inflammation, strong redness and swelling, tendency toward spontaneous bleeding, ulcerations After a score is given to each site the scores are summed together and divided by 4 to reach an overall score."|Baseline||||participants|||Number
2530357|NCT03400475|Primary|Change in Tumor Necrosis Factor Alpha 24 Hours to 1 Week|Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)|24hrs - 1 week||||Micrograms per deciliter (ug/dl)||Standard Deviation|Mean
2530358|NCT03400475|Primary|Change in Tumor Necrosis Factor Alpha at Base to 1 Week|Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)|Baseline - 1 week||||Micrograms per deciliter (ug/dl)||Standard Deviation|Mean
2530359|NCT03400475|Primary|Change in Tumor Necrosis Factor Alpha at Base to 24 Hours|Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)|Baseline- 24hrs||||Micrograms per deciliter (ug/dl)||Standard Deviation|Mean
2530360|NCT03400475|Primary|Change in Interleukin 8 24 Hours to 1 Week|Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)|24 hours - 1 week||||Micrograms per deciliter (ug/dl)||Standard Deviation|Mean
2530361|NCT03400475|Primary|Change in Interleukin 8 at Base to 1 Week|Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)|Baseline - 1 week||||Micrograms per deciliter (ug/dl)||Standard Deviation|Mean
2530362|NCT03400475|Primary|Change in Interleukin 8 at Base to 24 Hours|Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)|Baseline - 24 hours||||Micrograms per deciliter (ug/dl)||Standard Deviation|Mean
2530363|NCT03400475|Primary|Change in Interleukin 6 24 Hours - 1 Week|Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)|24 hours - 1 week||||Micrograms per deciliter (ug/dl)||Standard Deviation|Mean
2530364|NCT03400475|Primary|Change in Interleukin 6 Baseline to 1 Week|Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)|Baseline - 1 week||||Micrograms per deciliter (ug/dl)||Standard Deviation|Mean
2530365|NCT03400475|Primary|Change in Interleukin 6 at Base to 24 Hours|Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)|Baseline - 24 hours||||Micrograms per deciliter (ug/dl)||Standard Deviation|Mean
2530366|NCT03400475|Primary|Change in Interleukin 1 B 24 Hours - 1 Week|Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)|24 hours - 1 week||||Micrograms per deciliter (ug/dl)||Standard Deviation|Mean
2530367|NCT03400475|Primary|Change in Interleukin 1 B at Base to 1 Week|Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)|Baseline - 1 week||||Micrograms per deciliter (ug/dl)||Standard Deviation|Mean
2530368|NCT03400475|Primary|Change in Interleukin 1 B at Base to 24 Hours|Measuring the change in Cytokine levels in the peri implant crevicular fluid ( Fluid around the implant) by extracting the fluid and measuring the levels of the interlukins in the fluids in Micrograms per dicileter ( ug/dl)|Baseline- 24hrs||||Micrograms per deciliter (ug/dl)||Standard Deviation|Mean
2530369|NCT03400449|Secondary|Number of Participants Initiating Postpartum LARC Uptake|Number of participants initiating long-acting reversible contraception (LARC - intrauterine device (IUD) or implant) prior to hospital discharge.|Assessed at the time of hospital discharge, on average less than 2 days||||Participants|||Count of Participants
2531481|NCT03340805|Other Pre-specified|Adverse Events|Hyperlactatemia, hyperkalemia, hypercalcemia, hypernatremia, hyponatremia, hyperchloremia, therapy for brain herniation|up to four days post-randomization||||adverse events|||Number
2530372|NCT03400163|Secondary|Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142|Participants were monitored for antibodies to FGF21 using a validated homogenous bridge assay with Met-FGF21 (recombinant produced) and electrochemical luminescence detection. The number of treated participants with positive Anti-FGF21 antibody titers up to Day 142 with regards to baseline was reported for each arm.|From Day 1 to Day 142|"All treated participants~Note: data not reported due to privacy reasons"|||Participants|||Number
2530373|NCT03400163|Secondary|Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142|Participants were monitored for antibodies to study medication using a validated ADA homogenous bridge assay with BMS-986036 and electrochemical luminescence detection. The number of treated participants with positive Anti-BMS-986036 antibody titers up to Day 142 with regards to baseline was reported for each arm.|From Day 1 to Day 142|"All treated participants~Note: data not reported due to privacy reasons"|||Participants|||Number
2530374|NCT03400163|Secondary|Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112|The observed serum concentration of BMS-986036 before the next dose is administered (pre-dose concentration) was assessed for both C-terminal intact and total molecule. Geometric means are presented for each arm.|From Day 1 to Day 112|"All treated participants~Note: data not reported due to privacy reasons"|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2530375|NCT03400163|Primary|Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA)|The mean percent change in bone mineral density from baseline to day 112 reported for each arm.|From Day 1 to Day 112|"All treated participants with DXA data at baseline and 6 months~Note: data not reported due to privacy reasons"|||Percentage||Standard Deviation|Mean
2530376|NCT03400163|Primary|Number of Participants With Physical Examination Abnormalities|The number of participants with abnormalities observed during interim or final physical examination assessments is reported for each arm.|From first dose to date of last dose plus 30 days|"All treated participants~Note: data not reported due to privacy reasons"|||Participants|||Number
2530377|NCT03400163|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|The number of participants with out-of-range ECG intervals observed during interim or final electrocardiogram assessments was reported for each arm.|From first dose to date of last dose plus 30 days|"All treated participants~Note: data not reported due to privacy reasons"|||Participants|||Number
2530378|NCT03400163|Primary|Number of Participants With Vital Sign Abnormalities|The number of participants with out-of-range vital signs noted during interim or final vital sign assessments was reported for each arm.|From first dose to date of last dose plus 30 days|"All treated participants~Note: data not reported due to privacy reasons"|||Participants|||Number
2530379|NCT03400163|Primary|Number of Participants With Marked Laboratory Abnormalities|The number of participants whose worst toxicity grade increased from baseline to grade 3 or 4 (Toxicity Scale: DAIDS Version 1.0) is reported for each arm.|From first dose to date of last dose plus 30 days|"All treated participants~Note: data not reported due to privacy reasons"|||Participants|||Number
2530380|NCT03400163|Primary|Number of Deaths|The number of deaths was reported for each arm.|From first dose to date of last dose plus 30 days|"All treated participants~Note: data not reported due to privacy reasons"|||Participants|||Number
2530381|NCT03400163|Primary|Number of Participants With Adverse Events Leading to Discontinuation|The number of participants with on-study AEs leading to discontinuation was reported for each arm.|From first dose to date of last dose plus 30 days|"All treated participants~Note: data not reported due to privacy reasons"|||Participants|||Number
2530382|NCT03400163|Primary|Number of Participants With Injection Site Reactions|The number of participants with on-study injection site reactions was reported for each arm.|From first dose to date of last dose plus 30 days|"All treated participants~Note: data not reported due to privacy reasons"|||Participants|||Number
2530383|NCT03400163|Primary|Number of Participants With Serious Adverse Events (SAEs)|The number of participants with on-study SAEs was reported for each arm.|From first dose to date of last dose plus 30 days|"All treated participants~Note: data not reported due to privacy reasons"|||Participants|||Number
2530384|NCT03400163|Primary|Number of Participants With Adverse Events (AEs)|The number of participants with on-study AEs was reported for each arm.|From first dose to date of last dose plus 30 days|"All treated participants~Note: data not reported due to privacy reasons"|||Participants|||Number
2530385|NCT03400163|Primary|Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16|The mean change in percent hepatic fat fraction (%) by MRI from baseline to Week 16 was assessed for each arm. A longitudinal repeated measures analysis was used to analyze the change in hepatic fat fraction (%) at Week 16 from baseline in the treated population who have both a baseline and at least one post-baseline measurement.|From Day 1 to Day 112|"All treated participants~Note: data not reported due to privacy reasons"|||percentage||90% Confidence Interval|Mean
2530386|NCT03398421|Secondary|Change From Baseline in Temperature When Single Inhaled Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose|Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day 1, pre-dose), Days 2, 4, 6, 8 and 10|Safety population.|||Celsius||Standard Deviation|Mean
2530387|NCT03398421|Secondary|Change From Baseline in Temperature When Single Inhaled Oral Dose of Nemiralisib 100 mcg Administered|Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day 1, pre-dose) and Day 6|Safety population.|||Celsius||Standard Deviation|Mean
2530388|NCT03398421|Secondary|Change From Baseline in Respiratory Rate When Single Inhaled Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose|Respiratory rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day 1, pre-dose), Days 2, 4, 6, 8 and 10|Safety population.|||Breaths per minute||Standard Deviation|Mean
2532721|NCT03294629|Secondary|Average SA Detections|Average detects of arousal per hours. (Objective data recorded in the auto-CPAP machine)|2 weeks||||times/hour||Standard Deviation|Mean
2530389|NCT03398421|Secondary|Change From Baseline in Respiratory Rate When Single Inhaled Oral Dose of Nemiralisib 100 mcg Administered|Respiratory rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day 1, pre-dose) and Day 6|Safety population.|||Breaths per minute||Standard Deviation|Mean
2530390|NCT03398421|Secondary|Change From Baseline in Pulse Rate When Single Inhaled Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose|Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day 1, pre-dose) and Days 2, 4, 6, 8 and 10|Safety population.|||Beats per minute||Standard Deviation|Mean
2530391|NCT03398421|Secondary|Change From Baseline in Pulse Rate When Single Inhaled Oral Dose of Nemiralisib 100 mcg Administered|Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day 1, pre-dose) and Day 6|Safety population.|||Beats per minute||Standard Deviation|Mean
2530392|NCT03398421|Secondary|Change From Baseline in SBP and DBP When Single Inhaled Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose|Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day 1, pre-dose) and Days 2, 4, 6, 8 and 10|Safety population.|||Millimeter of mercury||Standard Deviation|Mean
2530393|NCT03398421|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) When Single Inhaled Oral Dose of Nemiralisib 100 mcg Administered|Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day 1, pre-dose) and Day 6|Safety population.|||Millimeter of mercury||Standard Deviation|Mean
2530394|NCT03398421|Secondary|Number of Participants With Abnormal Spirometry Values|Spirometry assessments were planned but not performed.|Period 1: Day -1; Period 2: Day 4|Safety population.||||||
2530395|NCT03398421|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Full 12-lead ECGs were recorded with the participant in a supine position. The number of participants with abnormal clinically significant ECG findings for worst case post-Baseline is presented.|Period 1: Up to Day 6; Period 2: Up to Day 10|Safety population.|||Participants|||Count of Participants
2530396|NCT03398421|Secondary|Number of Participants With Abnormal Microscopic Examinations: Casts, Epithelial Cells, Erythrocytes and Leukocytes|"A microscopic examination was performed as part of a routine urinalysis. The microscopic exam was performed on urine sediment - urine was centrifuged to concentrate the substances in it at the bottom of a tube. The fluid at the top of the tube was then discarded and the drops of fluid remaining were examined under a microscope. Cells, crystals, and other substances were counted and reported either as the number observed per low power field (LPF) or per high power field (HPF)."|Day -1|Safety population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2530397|NCT03398421|Secondary|Number of Participants With Urine Potential of Hydrogen (pH) at Indicated Time Points|Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).|Day -1, 6 and 10|Safety population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2530398|NCT03398421|Secondary|Number of Participants With Abnormal Urinalysis Parameter|The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as Trace and 2+ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented.|Days -1, 6 and 10|Safety population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2530399|NCT03398421|Secondary|Specific Gravity at Indicated Time Points|Urine samples were collected for analysis of specific gravity of urine. Urinary specific gravity is the measure of the concentration solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine.|Days -1, 6 and 10|Safety population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).|||Grams per cubic centimeter||Standard Deviation|Mean
2530400|NCT03398421|Secondary|Change From Baseline in Reticulocyte Percentage When Single Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg|Blood samples were collected for the analysis of reticulocyte percentage at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline and Day 10|Safety population.|||Percentage||Standard Deviation|Mean
2530401|NCT03398421|Secondary|Change From Baseline in Reticulocyte Percentage When Single Oral Dose of Nemiralisib 100 mcg Administered|Blood samples were collected for the analysis of reticulocyte percentage at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline and Day 6|Safety population.|||Percentage||Standard Deviation|Mean
2530402|NCT03398421|Secondary|Change From Baseline in MCV When Single Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg|Blood samples were collected for the analysis of MCV at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline and Day 10|Safety population.|||Femtoliter||Standard Deviation|Mean
2560002|NCT02669615|Primary|Cmax (Pharmacokinetics)|Maximum observed plasma concentration. Derived from the individual raw data.|Day -2||||ng/ml||Full Range|Median
2530403|NCT03398421|Secondary|Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) When Single Oral Dose of Nemiralisib 100 mcg Administered|Blood samples were collected for the analysis of MCV at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline and Day 6|Safety population.|||Femtoliter||Standard Deviation|Mean
2530404|NCT03398421|Secondary|Change From Baseline in MCH When Single Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg|Blood samples were collected for the analysis of MCH at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline and Day 10|Safety population.|||Picograms per liter||Standard Deviation|Mean
2530405|NCT03398421|Secondary|Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin (MCH) When Single Oral Dose of Nemiralisib 100 mcg Administered|Blood samples were collected for the analysis of MCH at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline and Day 6|Safety population.|||Picograms per liter||Standard Deviation|Mean
2530406|NCT03398421|Secondary|Change From Baseline in Hemoglobin When Single Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg|Blood samples were collected for the analysis of hemoglobin at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline and Day 10|Safety population.|||Grams per liter||Standard Deviation|Mean
2530407|NCT03398421|Secondary|Change From Baseline in Hemoglobin When Single Oral Dose of Nemiralisib 100 mcg Administered|Blood samples were collected for the analysis of hemoglobin at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline and Day 6|Safety population.|||Grams per liter||Standard Deviation|Mean
2530408|NCT03398421|Secondary|Change From Baseline in Hematocrit When Single Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg|Blood samples were collected for the analysis of hematocrit at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline and Day 10|Safety population.|||Percentage of red blood cells in blood||Standard Deviation|Mean
2530409|NCT03398421|Secondary|Change From Baseline in Hematocrit When Single Oral Dose of Nemiralisib 100 mcg Administered|Blood samples were collected for the analysis of hematocrit at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline and Day 6|Safety population.|||Percentage of red blood cells in blood||Standard Deviation|Mean
2530410|NCT03398421|Secondary|Change From Baseline in Hematology Parameters When Single Oral Dose of Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Lymphocytes, Neutrophils, Platelets, Basophils, Eosinophils, Monocytes, Erythrocytes and WBC|Blood samples were collected for the analysis of hematology parameters including lymphocytes, neutrophils, platelets, basophils, eosinophils, monocytes, erythrocytes and WBCs at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline and Day 10|Safety population.|||10^9 cells per liter||Standard Deviation|Mean
2530411|NCT03398421|Secondary|Change From Baseline in Hematology Parameters When Single Oral Dose of Nemiralisib 100 mcg Administered: Lymphocytes, Neutrophils, Platelets, Basophils, Eosinophils, Monocytes, Erythrocytes and White Blood Cells (WBC)|Blood samples were collected for the analysis of hematology parameters including lymphocytes, neutrophils, platelets, basophils, eosinophils, monocytes, erythrocytes and WBCs at indicated time points. Day -1 was defined as Baseline for hematology parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline and Day 6|Safety population.|||10^9 cells per liter||Standard Deviation|Mean
2530412|NCT03398421|Secondary|Change From Baseline of Total Protein When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose|Blood samples were collected for the analysis of total protein at indicated time points. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline, Day 2, 4, 6, 8 and 10|Safety population.|||Gram per liter||Standard Deviation|Mean
2530413|NCT03398421|Secondary|Change From Baseline of Total Protein When Single Inhaled Oral Dose of Nemiralisib 100 mcg Administered|Blood samples were collected for the analysis of total protein at indicated time points. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline and Day 6|Safety population.|||Gram per liter||Standard Deviation|Mean
2530414|NCT03398421|Secondary|Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg Co-administered With Itraconazole 200 mg Repeated Dose: Bilirubin, Direct Bilirubin and Creatinine|Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, direct bilirubin and creatinine at indicated time points. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline, Day 2, 4, 6, 8 and 10|Safety population.|||Micromoles per liter||Standard Deviation|Mean
2530415|NCT03398421|Secondary|Change From Baseline of Clinical Chemistry Parameters When Single Inhaled Oral Dose of Nemiralisib 100 mcg Administered:Bilirubin, Direct Bilirubin and Creatinine|Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, direct bilirubin and creatinine at indicated time points. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline and Day 6|Safety population.|||Micromoles per liter||Standard Deviation|Mean
2530416|NCT03398421|Secondary|Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Alkaline Phosphate, ALT and AST|Blood samples were collected for the analysis of clinical chemistry parameters including alkaline phosphate, ALT and AST at indicated time points. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline, Day 2, 4, 6, 8 and 10|Safety population.|||International Units/ Liter||Standard Deviation|Mean
2530417|NCT03398421|Secondary|Change From Baseline of Clinical Chemistry Parameters When Single Inhaled Oral Dose of Nemiralisib 100 mcg Administered: Alkaline Phosphate, Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)|Blood samples were collected for the analysis of clinical chemistry parameters including alkaline phosphate, ALT and AST at indicated time points. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline and Day 6|Safety population.|||International Units/ Liter||Standard Deviation|Mean
2530418|NCT03398421|Secondary|Change From Baseline of Clinical Chemistry Parameters When Nemiralisib 100 mcg When Co-administered With Itraconazole 200 mg Repeated Dose: Calcium, Glucose, Potassium and Sodium|Blood samples were collected for the analysis of clinical chemistry parameters including calcium, glucose, potassium and sodium. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day -1), Day 2, 4, 6, 8 and 10|Safety population.|||Millimoles/Liter||Standard Deviation|Mean
2530419|NCT03398421|Secondary|Change From Baseline of Clinical Chemistry Parameters When Single Inhaled Oral Dose of Nemiralisib 100 mcg Administered: Calcium, Glucose, Potassium and Sodium|Blood samples were collected for the analysis of clinical chemistry parameters including calcium, glucose, potassium and sodium. Day -1 was defined as Baseline for clinical chemistry parameters. Change from Baseline is calculated as the value at specified time point minus the Baseline value.|Baseline (Day -1) and Day 6|Safety population.|||Millimoles/Liter||Standard Deviation|Mean
2530420|NCT03398421|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per Medical or scientific judgement. Safety population comprised of all participants enrolled in the study, who took at least one dose of study treatment.|Up to 35 days|Safety population.|||Participants|||Count of Participants
2530421|NCT03398421|Secondary|Tmax of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2|Blood samples were collected at indicated time points after administration of repeated doses of Itraconazole and Hydroxy Itraconazole along with Nemiralisib. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (itraconazole) on Day 1; Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose (itraconazole) on Day 5|Pharmacokinetic population.|||Hour||Full Range|Median
2530422|NCT03398421|Secondary|T1/2 of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2|Blood samples were collected at indicated time points after administration of repeated doses of Itraconazole and Hydroxy Itraconazole along with Nemiralisib. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (itraconazole) on Day 1; Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose (itraconazole) on Day 5|Pharmacokinetic population. Only those participants with data available at specified time points were analyzed. NA indicates T1/2 for hydroxy itraconazole (Day 1 and Day 5) and Itraconazole (Day 5) could not be calculated as it was not possible to get accurate measurements since the length was too long for sampling.|||Hour||Geometric Coefficient of Variation|Geometric Mean
2530423|NCT03398421|Secondary|Cmax of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2|Blood samples were collected at indicated time points after administration of repeated doses of Itraconazole and Hydroxy Itraconazole along with Nemiralisib. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (itraconazole) on Day 1; Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose (itraconazole) on Day 5|Pharmacokinetic population.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2530424|NCT03398421|Secondary|AUC(0-t) of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2|Blood samples were collected at indicated time points after administration of repeated doses of Itraconazole along with Nemiralisib. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (itraconazole) on Day 1; Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose (itraconazole) on Day 5|Pharmacokinetic population.|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2530425|NCT03398421|Secondary|AUC(0-inf) of Itraconazole and Hydroxy Itraconazole When Co-administered With Nemiralisib in Treatment Period 2|Blood samples were collected at indicated time points after administration of repeated doses of itraconazole along with Nemiralisib. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (itraconazole) on Day 1; Pre-dose, 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose (itraconazole) on Day 5|Pharmacokinetic population. Only those participants with data available at specified time points were analyzed. NA indicates AUC (0-inf) for hydroxy itraconazole (Day 1 and Day 5) and Itraconazole (Day 5) could not be calculated as it was not possible to get accurate measurements since the length was too long for sampling.|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Least Squares Mean
2530426|NCT03398421|Primary|Time to Maximum Observed Plasma Concentration (Tmax) of Nemiralisib in Plasma|Blood samples were collected at indicated time points after administration of repeated doses of itraconazole along with Nemiralisib. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Period 1: Pre-dose, and 5, 30 minutes, 2, 6, 12, 24, 48, 72, 96 and 120 hours post-dose on Day 1. Period 2: Pre-dose, and 5 min, 30 min, 2, 6, 12, 24, 48, 72, 96, 120 and 144 hours post-dose on Day 5|Pharmacokinetic population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).|||Hour||Full Range|Median
2530479|NCT03390166|Primary|Number of Participants With Unsolicited Adverse Events.|Unsolicited adverse events (AEs) occurring within 90 days post-vaccination. Percentage of participants experiencing each reaction will be calculated.|within 90 days post-vaccination|The analysis was conducted for participants who were randomized and received a study vaccination by Intention to Treat analysis|||Participants|||Count of Participants
2530427|NCT03398421|Primary|Apparent Terminal Half-life (t1/2) of Nemiralisib in Plasma|Blood samples were collected from participants at indicated time frames after the administration of study treatment to investigate pharmacokinetic parameters of Nemiralisib in both treatment period 1 and 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Period 1: Pre-dose, and 5, 30 minutes, 2, 6, 12, 24, 48, 72, 96 and 120 hours post-dose on Day 1. Period 2: Pre-dose, and 5 min, 30 min, 2, 6, 12, 24, 48, 72, 96, 120 and 144 hours post-dose on Day 5|Pharmacokinetic population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).|||Hours||Geometric Coefficient of Variation|Geometric Mean
2530428|NCT03398421|Primary|Maximum Observed Plasma Concentration (Cmax) of Nemiralisib in Plasma|Blood samples were collected from participants at indicated time frames after the administration of study treatment to investigate pharmacokinetic parameters of Nemiralisib in both treatment period 1 and 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Period 1: Pre-dose, and 5, 30 minutes, 2, 6, 12, 24, 48, 72, 96 and 120 hours post-dose on Day 1. Period 2: Pre-dose, and 5 min, 30 min, 2, 6, 12, 24, 48, 72, 96, 120 and 144 hours post-dose on Day 5|Pharmacokinetic population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).|||Picogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2530429|NCT03398421|Primary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC [0-t]) of Nemiralisib in Plasma|Blood samples were collected from participants at indicated time frames after the administration of study treatment to investigate pharmacokinetic parameters of Nemiralisib in both treatment period 1 and 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Period 1: Pre-dose, and 5, 30 minutes, 2, 6, 12, 24, 48, 72, 96 and 120 hours post-dose on Day 1. Period 2: Pre-dose, and 5 min, 30 min, 2, 6, 12, 24, 48, 72, 96, 120 and 144 hours post-dose on Day 5|Pharmacokinetic population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).|||Hour*picogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2530430|NCT03398421|Primary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of Nemiralisib in Plasma|Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic parameters of nemiralisib in both treatment period 1 and 2. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Pharmacokinetic population comprised of all participants enrolled in the study who took at least 1 dose of nemiralisib and for whom a nemiralisib pharmacokinetic sample was obtained and analyzed.|Period 1: Pre-dose, and 5, 30 minutes, 2, 6, 12, 24, 48, 72, 96 and 120 hours post-dose on Day 1. Period 2: Pre-dose, and 5 min, 30 min, 2, 6, 12, 24, 48, 72, 96, 120 and 144 hours post-dose on Day 5|Pharmacokinetic population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).|||Hours*picogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2530431|NCT03398330|Secondary|Number of AEs Related to Physical Examination|Physical examination were measured at Screening, 1 day before IMP dosing and 4 days after IMP dosing in each period.|up to 35 days||||AEs related to Physical examination|||Number
2530432|NCT03398330|Secondary|Number of AEs Related to ECGs|Summarized table of 12-lead ECG is presented. ECG was measured at Screening and 4 days after IMP dosing in Period 2.|up to 35 days||||AEs of ECG related|||Number
2530433|NCT03398330|Secondary|Number of AEs Related to Vital Signs|Vital sign parameters to be summarised include systolic blood pressure, diastolic blood pressure, pulse rate, respiration rate, and axillary temperature.Vital sign results for each parameter will be assigned an LNH classification according to whether the value is lower than (L), within (N), or higher than (H) the reference range for that parameter. Vital sign results will be summarised using shift tables to evaluate categorical changes from baseline to end of study with respect to reference range values (lower than, within, and higher than).|up to 35 days||||AEs of vital signs related|||Number
2530434|NCT03398330|Secondary|Number of Lab Tests With Clinical Significance|Clinical laboratory data to be summarised includes haematology, blood chemistry, and urinalysis.Each parameter will be assigned an LNH classification according to whether the value is lower than (L), within (N) or higher than (H) the reference range for that parameter. Results will be summarised using shift tables to evaluate categorical changes from baseline to end of study with respect to reference range values (lower than, within, and higher than).|up to 35 days||||Lab tests with clinical significance|||Number
2530435|NCT03398330|Secondary|Adverse Events of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fed State|An overall summary of the number and percentage of Adverse Events will be provided for each treatment groups to assess the safety of OTR tablet 40 mg and OXYCONTIN® tablet 40 mg.|up to 35 days||||TEAEs|||Number
2530436|NCT03398330|Primary|AUCINF of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State|The analysis was for PK parameters AUCINF for analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) was used to compare the test and the reference treatments.|up to 32 hours||||ng*h/ml||90% Confidence Interval|Mean
2530437|NCT03398330|Primary|AUCt of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State|The analysis was for PK parameters AUCt of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments.|up to 32 hours||||ng*h/ml||90% Confidence Interval|Mean
2530438|NCT03398330|Primary|Cmax of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fed State|The analysis was for PK parameters Cmax of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments.|up to 32 hours||||ng/ml||90% Confidence Interval|Mean
2530439|NCT03398278|Secondary|Number of AEs Related to Physical Examination|Physical examination was conducted at screening, and on Day -1, Day 4 in each Period.|up to 35 days||||AEs related to Physical examination|||Number
2530440|NCT03398278|Secondary|Number of AEs Related to ECGs|Twelve-lead ECG was conducted at screening and on Day 4 of Period 2.|up to 35 days||||AEs of ECG related|||Number
2546969|NCT02915029|Secondary|Low-density Lipoprotein LDL Cholesterol|Changes in serum LDL cholesterol on study|12 months minus baseline values||||mg/dl||Standard Deviation|Mean
2530441|NCT03398278|Secondary|Number of AEs Related to Vital Sign|Vital sign parameters to be summarised include systolic blood pressure, diastolic blood pressure, pulse rate, respiration rate, and axillary temperature. Vital sign results for each parameter will be assigned an LNH classification according to whether the value is lower than (L), within (N), or higher than (H) the reference range for that parameter. Vital sign results will be summarised using shift tables to evaluate categorical changes from baseline to end of study with respect to reference range values (lower than, within, and higher than).|up to 35 days||||AEs of vital signs related|||Number
2530442|NCT03398278|Secondary|Number of Lab Tests With Clinical Significance|Clinical laboratory data to be summarised includes haematology, blood chemistry, and urinalysis.Each parameter will be assigned an LNH classification according to whether the value is lower than (L), within (N) or higher than (H) the reference range for that parameter. Results will be summarised using shift tables to evaluate categorical changes from baseline to end of study with respect to reference range values (lower than, within, and higher than).|up to 35 days||||Lab tests with clinical significance|||Number
2530443|NCT03398278|Secondary|Adverse Event of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg, When Given to Chinese Subjects With Chronic Pain in a Fasted State|An overall summary of adverse events will be provided by treatment groups. The number and percentage of subjects reporting adverse events will be summarised by the preferred term nested within the System Organ Classification. In addition the number of reported adverse events will be summarised.|up to 35 days||||TEAEs|||Number
2530444|NCT03398278|Primary|AUCINF of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fasted State|The analysis was for PK parameters AUCINF for analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) was used to compare the test and the reference treatments.|up to 32 hours||||ng*h/ml||90% Confidence Interval|Mean
2530445|NCT03398278|Primary|AUCt of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fasted State|The analysis was for PK parameters AUCt of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments.|up to 32 hours||||ng*h/ml||90% Confidence Interval|Mean
2530446|NCT03398278|Primary|Cmax of OTR Tablet 40 mg and OXYCONTIN Tablet 40 mg in a Fasted State|The analysis was for PK parameters Cmax of analyte oxycodone. Analysis of Variance (ANOVA) with fixed effect terms for treatment, period, sequence, and subject within sequence for ratio of means (using log scale) were used to compare the test and the reference treatments.|up to 32 hours||||ng/mL||90% Confidence Interval|Mean
2530447|NCT03396835|Primary|Trending Regional Oxygen Saturation Accuracy of the INVSENSOR00009 Relative to the Control Sensor by Arms Calculation|Trending ARMs accuracy is defined as root mean squared relative error of all data points of all subjects. Accuracy of the sensors will be determined by comparing regional oxygen saturation (rSO2) readings from INVSENSOR00009 and control sensor and calculating the Arithmetic root mean square (ARMS) value.|1-5 hours||||% tissue oxygen saturation|||Number
2530448|NCT03395886|Secondary|Number of Participants With NIV Mitigation|Mitigation was defined by patients who were relieved from the initial intolerant status|72 hours after the initiation of sedation|The generalized estimating equations approach was employed to analyze changes in the mitigation rate over time between the two groups.|||Participants|||Count of Participants
2530449|NCT03395886|Primary|Number of Participants With NIV Failure|NIV failure was defined by reintubation or death in the course of this study|72 hours after the initiation of sedation|Summary statistics are expressed as numbers and percentages and compared between groups by Chi-square test.|||Participants|||Count of Participants
2530450|NCT03394391|Secondary|Number of Participants With Mental Distress Determined by General Health Questionnaire 12 at 20 Weeks|The General Health Questionnaire 12 (GHQ12) will be used to assess the mental health status of all the participants. It is a well-validated and widely used instrument for screening for mental health distress. It is a 12-item questionnaire that is based on a 4-point likert scale scored from 0 to 3 points. The scores will range between 0 and 36. A score of 12 or more is suggestive of mental distress while scores less than 12 suggest that mental distress is absent.|End of study (20weeks)||||Participants|||Count of Participants
2530451|NCT03394391|Secondary|Patient Satisfaction Score at 20 Weeks|Patient satisfaction will be assessed using a 22-item adaptation of the SERVQUAL tool. It is a multi-dimensional service quality assessment tool that uses a 5-point likert scale scored from 1 to 5 points to assess 5 domains of client satisfaction. The domains are tangibility (4 items; scores from 4 to 20), reliability (5 items; scores from 5 to 25), responsiveness (4 items; scores from 4 to 20), assurance (4 items; scores from 4 to 20), and empathy (5 items; scores from 5 to 25). Patient satisfaction is measured by the total score which will range between 22 and 110. Higher scores indicate better client satisfaction.|End of Study (20weeks)||||score on a scale||Standard Deviation|Mean
2530452|NCT03394391|Primary|ART Adherence at 20 Weeks as Determined by Log of Viral Load Count|log of viral load count is log 10 transformation of the viral load values|20week [End of study]||||log10 copies/mL||Standard Deviation|Mean
2530453|NCT03394391|Primary|ART Adherence at 20 Weeks as Determined by Viral Load Count|Viral load count is measured in copies per ml. The minimum value is 0. There is no maximum value. The higher values reflect poor adherence|20 week [End of study]||||copies/mL||Standard Deviation|Mean
2530454|NCT03394391|Primary|ART Adherence at 20 Weeks as Determined by Pill Counts, ACTG Adherence Questionnaire, and VAS Scores|"AIDS Clinical Trials Group Scale scores range from 0 to 1. The higher scores reflect better ART adherence Pill count scores also range from 0 to 1 and the higher scores also reflect better adherence.~Visual analog scale [VAS] adherence ranges between 0 and 100%. Higher scores reflect better ART adherence"|20week [End of study]||||measurement vlaues and score on a scale||Standard Deviation|Mean
2530455|NCT03394391|Primary|ART Adherence at 20 Weeks as Determined by VAS, Viral Load|"ART adherence is assessed by different well-validated methods. In this study, ART adherence will be measured, primarily, using the self-report visual analog scale. The scale is well-validated, self-report of the level of ART adherence with a range from 0 to 100%. While higher values indicate better levels of adherence, patients with adherence levels of 95% and above are regarded as ART-adherent while those with values less than 95% are not adherent to ART medications.~Viral load is the number of copies of viral RNA detected in participants' blood. Participants with viral load </=20 copies per ml are regarded to have optimal viral suppression indicative of optimal adherence to medications."|20week [End of study]||||Participants|||Count of Participants
2530456|NCT03393208|Secondary|Number of Participants With Clinically Significant Abnormalities in Vital Signs, Laboratory Parameters, Physical Examination Findings and 12-lead Electrocardiogram (ECG) Findings|The laboratory measurements included hematology, blood chemistry and urinalysis. Vital sign assessment included blood pressure, pulse rate and body temperature. ECG parameters included heart rate, PR, QRS,QT, RR, QTcB and QTcF Here, we are reporting number of participants with clinically significant abnormalities in Vital signs, laboratory parameters, physical findings and ECG findings.|Baseline up to Day 15|"The Safety Analysis Set included all participants who received at least 1 dose of study drug. Here number of particpants were analyzed who were evaluable for this outcome measure."|||Participants|||Count of Participants
2530457|NCT03393208|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs|An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration. TEAEs included both Serious TEAEs and non-serious TEAEs.|Baseline up to Day 15|The Safety Analysis Set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2530458|NCT03393208|Secondary|Apparent Volume of Distribution at Steady-State After Extravascular Administration (Vss/f) of Metformin|Vss/F was derived from concentration versus time data for all participants.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3|As AUCextra was >20% of AUC0-inf, Vss/f derived from λz was regarded as unreliable estimate of the extent of exposure and not calculated.||||||
2530459|NCT03393208|Secondary|Apparent Volume of Distribution at After Extravascular Administration (Vz/f) of Metformin (GIR Tablet Active Ingredient)|Vz/f is defined as the distribution of a study drug between plasma and the rest of the body after oral dosing.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3|The Pharmacokinetic analysis set. . Here “Number of participants analyzed” signifies those participants who were evaluable for this outcome measure.|||liter||Geometric Coefficient of Variation|Geometric Mean
2530460|NCT03393208|Secondary|Total Body Clearance (CL/f) of Metformin (GIR Tablet Active Ingredient)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3|The Pharmacokinetic analysis set. Here “Number of participants analyzed” signifies those participants who were evaluable for this outcome measure.|||liter per hour||Geometric Coefficient of Variation|Geometric Mean
2530461|NCT03393208|Secondary|Elimination Rate Constant (λz) of Metformin (GIR Tablet Active Ingredient)|λz was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3|As AUCextra was >20% of AUC0-inf, parameters derived from λz were regarded as unreliable estimate of the extent of exposure and not calculated.||||||
2530462|NCT03393208|Secondary|Area Under the Plasma Concentration-Time Curve From Time Tlast Extrapolated to Infinity (AUCextra) of Metformin (GIR Tablet Active Ingredient)|AUCextra% was defined as area under the curve from time tlast extrapolated to infinity as percentage of AUC 0-infinity. Here, tlast is the last sampling time at which the concentration is at or above the lower limit of quantification.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3|As AUCextra was >20% of AUC0-inf, parameters derived from λz including AUCextra% were regarded as unreliable estimate of the extent of exposure and not calculated.||||||
2530463|NCT03393208|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Metformin (GIR Tablet Active Ingredient)|AUC0-inf was calculated by combining AUC0-t and AUCextra. AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3|The Pharmacokinetic analysis set. Here “Number of participants analyzed” signifies those participants who were evaluable for this outcome measure.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2530464|NCT03393208|Secondary|Apparent Terminal Half-Life (t1/2) of Metformin (GIR Tablet Active Ingredient)|Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3|"The Pharmacokinetic analysis set. Here Number of particpants analyzed signifies those participants who were evaluable for this outcome measure."|||hours||Geometric Coefficient of Variation|Geometric Mean
2530465|NCT03393208|Secondary|Time to Reach Maximum Plasma Concentration of Metformin (GIR Tablet Active Ingredient)|Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3|The Pharmacokinetic analysis set.|||hours||Full Range|Median
2530466|NCT03393208|Primary|Maximum Observed Plasma Concentration (Cmax) of Metformin (GIR Tablet Active Ingredient)|Pharmacokinetic (PK) parameter Cmax was obtained directly from the concentration versus time curve.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3|The Pharmacokinetic analysis set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2546970|NCT02915029|Secondary|Body Mass Index|Changes in the value of body mass index (BMI)|12 months minus baseline values||||kg/m^2||Standard Deviation|Mean
2530467|NCT03393208|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of Metformin (GIR Tablet Active Ingredient)|Area under the plasma concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ). AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3|The Pharmacokinetic (PK) Analysis Set included all participants who completed the study with adequate study drug compliance, without any relevant protocol violations with respect to factors likely to affect comparability of PK results, and with sufficient evaluable data to determine primary endpoints (AUC0-t and Cmax ) for both treatments.|||nanogram hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2530468|NCT03392532|Primary|Percentage of Lenses With Axis Orientation Within ±30 Degrees From the 90 Degree Axis (Ideal Location)|Each lens was classified based on whether the absolute difference between the axis location and 90° was less than or equal to 30° (ie, lens axis located between the 60° and 120° axis inclusive). Inferential testing was not planned for this primary effectiveness endpoint.|Day 1, 10 minutes after lens insertion, each product|Full Analysis Set|||percentage of lenses|Eyes||Number
2530469|NCT03392194|Primary|Sleep Duration|Change in sleep duration from baseline to follow-up measure by actigraphs. We will conduct a repeated measures ANCOVA, modeling time, intervention group and a time*intervention interaction. We will explore change in stress, anxiety, depressive symptoms, mindfulness, and sleep hygiene score as potential explanatory variables.|12 weeks|The missing count is based on 21 participants having adequate quality actigraphy data at both baseline and endpoint|||minutes/night||Standard Deviation|Mean
2530470|NCT03391986|Secondary|Percentage of Patients Rated Good or Very Good on Satisfaction Survey in Overall Care - Acupuncture Versus Routine Care|Using a satisfaction survey (investigator-developed, 6 questions, each question is graded on a scale of 1-5, 1 being very poor and 5 being very good) to measure effectiveness of auricular acupuncture for improving satisfaction.|at the completion of the procedure (approximately 5-10 minutes)|The final analysis included 150 (out of 153) participants: 52 in the auricular acupuncture group, 49 in the placebo group and 49 in the routine (usual) care group.|||percentage of participants|||Number
2530471|NCT03391986|Secondary|Change in Visual Analog Scale for Pain (VAS Pain) Score - Placebo Versus Routine Care|Measure effectiveness of placebo as an adjunct to ibuprofen and paracervical block for pain control during uterine aspiration by comparing the maximum pain score; as measured by VAS between women randomized to receive placebo adhesives and routine care controls - using a 100 mm visual analog scale (VAS-P) (anchors: 0 mm = no pain, 100 mm = worst pain in my life).|prior to the procedure (baseline), at the completion of the procedure (approximately 10 minutes later)|The final analysis included 150 (out of 153) participants: 52 in the auricular acupuncture group, 49 in the placebo group and 49 in the routine (usual) care group.|||score on a scale||Inter-Quartile Range|Mean
2530472|NCT03391986|Primary|Visual Analog Scale for Pain (VAS Pain) Score - Acupuncture Versus Routine Care|Measure effectiveness of auricular acupuncture as an adjunct to ibuprofen and paracervical block for pain control during first trimester uterine aspiration by comparing the maximum pain score; as measured by VAS between women randomized to receive auricular acupuncture and routine care controls - using a 100 mm visual analog scale (VAS-P) (anchors: 0 mm = no pain, 100 mm = worst pain in my life). The VAS has no sub-scales.|at the completion of the procedure (approximately 10 minutes later)|The final analysis included 150 (out of 153) participants: 52 in the auricular acupuncture group, 49 in the placebo group and 49 in the routine (usual) care group.|||score on a scale||Inter-Quartile Range|Mean
2530473|NCT03391115|Other Pre-specified|Usability Assessment Via the System Usability Scale(SUS), Range of 0 to 100, With Higher Number Representing a Better Outcome SUS Scores Have a Range of 0 to 100, the Higher the Number Represents a Better Outcome.|This study will utilize an observational design to define and refine the storytelling intervention, seeking input from the key stakeholders: providers (acute care bedside nurses).The SUS scale is a 10 item Likert scale which gives a global view of subjective assessment of usability with five item responses options from strongly agree to strongly disagree. SUS yields a single number representing a composite measure of the overall usability of the system being studied. Note that scores for individual items are not meaningful on their own. To calculate the SUS score, first sum the score contributions from each item. Each item's score contribution will range from 0 to 4. For items 1,3,5,7, and 9, the score contribution is the scale position minus 1. For items 2,4,6,8, and 10, the contribution is 5 minus the scale position. Multiply the sum of the scores by 2.5 to obtain the overall value of the SUS, with the higher the number, the better the outcome.|1-2 weeks|Patient Participants did not complete this secondary measure. This was only the nurse participants completing the NIH System Usability Scale|||score on a scale||Full Range|Mean
2530474|NCT03391115|Primary|Number of Completed Exit Interviews From Patients on Feasibility of Their Use of Their Narrative Integrated Into EHR|Using an observational design, this measure (exit interviews) were completed with 20 inpatient participants and 18 nurse participants. The qualitative data from the interviews were used to define and refine the storytelling intervention. The data collected from the exit interview is qualitative in nature and therefore does not have a numerical value.|1-2 weeks||||Participants|||Count of Participants
2530475|NCT03390426|Secondary|Amount of Esmolol Used Intraoperatively||Intraoperatively (~3 hours)|Subjects who completed the study.|||mg||Standard Deviation|Mean
2530476|NCT03390426|Secondary|Amount of Opioid Pain Medications Used by Patient||Perioperative period (~4 hours)|Subjects who completed the study.|||morphine equivalents||Standard Deviation|Mean
2530477|NCT03390426|Secondary|Pain Scores as Measured by the Numeric Rating Scale (NRS-11)|The NRS-11 is an 11-point scale for patient self-reporting of pain. 0 = No Pain, 1-3 = Mild Pain, 4-6 = Moderate Pain, 7-10 = Severe Pain.|While in PACU (~1 hour)|Subjects who completed the study.|||score on a scale||Standard Deviation|Mean
2530478|NCT03390426|Primary|Number of Subjects Experiencing Tourniquet Hypertension|Measuring systolic blood pressure using a cuff, aim to keep <30mmHg change from baseline|Intraoperatively (~3 hours)|Subjects who completed the study.|||Participants|||Count of Participants
2530493|NCT03387046|Secondary|Number of Treated Participants With Immune-metabolic Response of Lymphocytes|Treated participants with immune-metabolic response (glycolysis, mitochondrial respiration, fatty acids oxidation and circulating adipocytokines) of lymphocytes were to be reported.|Baseline, Week 8 and 12|Data was not collected since the study was prematurely terminated, due to slow recruitment rate.||||||
2530480|NCT03390166|Primary|Number of Participants With Solicited Local and Systemic Adverse Events Post-vaccination.|"Solicited local and systemic adverse events within 30 minutes of vaccination and over the 3-day period post vaccination.~Percentage of participants experiencing each reaction was calculated. Analysis based on Intention to Treat analysis"|30-minutes period,day 1,day 2 and day 3 post-vaccination period|The analysis was conducted for participants who were randomized and received a study vaccination. Analysis based on Intention to Treat Analysis|||Participants|||Count of Participants
2530481|NCT03390166|Primary|Geometric Mean Titers (GMTs) of Participants at 21 Days Post-vaccination|"Geometric mean titers (GMTs) of serum HI antibodies pre- (Day 0) and post-vaccination (Day 21) for each of the three vaccine antigens.~Note that titers below the lowest limit of quantitation (i.e., below the starting dilution of assay reported as < 10) will be set to half that limit (i.e., 10/ 2 = 5). If a titer is reported as greater or equal to the upper limit of the assay, it will be set to that limit."|pre-vaccination (Day 0), 21 days post-vaccination|Geometric mean titer against the hemagglutinin antigens contained in the vaccine were assessed in all studied participants. The analysis was performed as intention-to-treat (ITT).|||titer||95% Confidence Interval|Geometric Mean
2530482|NCT03390166|Primary|Number and Percentage of Seroconverted Participants at 21 Days Post-vaccination|"Seroconversion is defined as a serum HI antibody titer meeting the following four fold rising criteria.~Pre-vaccination titer <1:10 and a post-vaccination titer measured on Day 21 of ≥1:40; or Pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination measured on Day 21.~Measured against each of the 3 antigens"|pre-vaccination (Day 0), 21 days post-vaccination|Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in all studied participants. The analysis was performed as intention-to-treat (ITT).|||Participants|||Count of Participants
2530483|NCT03387683|Secondary|Adjusted Mean Change From Baseline in Myocardial Efficiency at End of Treatment.|A clinical radiologic assessment of acquired computed tomography and positron emission tomography (CTPET)-[11C]-acetate images was performed to determine myocardial efficiency. The myocardial efficiency calculation was based on an estimate of energy used for producing LV contractile work (mean arterial pressure (MAP) x stroke volume (SV) x heart rate (HR) / myocardial mass) compared to the total cardiac work (calculated based on the total myocardial oxygen consumption per myocardial mass) and is expressed as a percentage. The LSM change from baseline estimates, were generated from an ANCOVA model with treatment and baseline value of the endpoint as covariates.|Baseline (Day 1) and end of treatment (Day 42)|Patients in the CTPET-[11C]-acetate evaluable analysis set who, as per clinical judgment, had fasted and abstained from products containing nicotine, caffeine and alcohol for at least 6 hours prior to both of the times when CTPET-[11C]-acetate measurements were taken.|||Percentage of Myocardial Efficiency||95% Confidence Interval|Least Squares Mean
2530484|NCT03387683|Primary|Adjusted Mean Change From Baseline in Global Longitudinal Strain of the Left Ventricle (GLSLV) at End of Treatment.|Patients underwent magnetic resonance imaging (MRI) examination to determine the GLSLV, which is expressed as a percentage. The least square mean (LSM) change from baseline estimates were generated from an analysis of covariance (ANCOVA) model with treatment and baseline value of the endpoint as covariates.|Baseline (Day 1) and end of treatment (Day 42)|Patients in the MRI evaluable analysis set who, as per clinical judgment, had fasted and abstained from products containing nicotine, caffeine and alcohol for at least 6 hours prior to both of the times when MRI measurements were taken.|||Percentage of GLSLV||95% Confidence Interval|Least Squares Mean
2530485|NCT03387462|Secondary|Assessment of Situations and Reasons for Sub-optimal Use of the App|Combined analysis of situations and reasons for sub-optimal use of the app, for the purpose of app optimization|8 weeks|MSM eligible for or taking PrEP|||Count of participants for each reason|||Number
2530486|NCT03387462|Primary|Adherence and Persistence of Use of the DOT and Sexual Diary Components of DOT Diary by Young MSM on PrEP|Percentage of doses taken with visual confirmation of pill ingestion|8 weeks|MSM eligible for or taking PrEP|||Percentage of doses taken|||Number
2530487|NCT03387462|Primary|DOT Diary Mobile App Ease of Use|5-point Likert scale (1=strongly disagree that app is easy to use; 5=strongly agree that app is easy to use) of key attributes of ease of use of DOT Diary over 8 weeks by MSM on PrEP.|8 weeks||||Score on a scale (Likert)||Inter-Quartile Range|Median
2530488|NCT03387462|Primary|DOT Diary Mobile App Acceptability|System Usability Scale (SUS) of 1-100 regarding key attributes of acceptability of DOT Diary over 8 weeks by MSM on PrEP, in order to identify potential improvements to the app to maximize acceptability. Higher numbers indicate more favorable responses regarding acceptability.|8 weeks|MSM eligible for or taking PrEP|||Score on scale||Standard Deviation|Mean
2530489|NCT03387059|Secondary|Number of Participants With Device Incidents|A medical device incident is any malfunction or deterioration in the characteristics and/or clinical performance of a device, as well as any inadequacy in the labelling or the instructions for use (IFU) which, directly or indirectly, might lead to or might have led to the death of a participant, or user or of other persons or to a serious deterioration in their state of health.|Day 2 post-randomization (PR) up to Post Embryo Transfer (PET) Days 70 to 84|Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate.||||||
2530490|NCT03387059|Secondary|Number of Participants With Confirmed Ongoing Pregnancy|Ongoing pregnancy was defined as having a positive fetal heart beat (FHB) as assessed by obstetric ultrasound (transvaginal or abdominal).|Post Embryo Transfer (PET) Days 70 to 84|Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate.||||||
2530491|NCT03387059|Secondary|Number of Participants With Positive and Negative Pregnancy|Positive and Negative Pregnancy measured by Day 14 serum beta Human chorionic gonadotropin (Beta-HCG) pregnancy test.|At Post Embryo Transfer (PET) Day 14|Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate.||||||
2530492|NCT03387059|Primary|Implantation Rate|Implantation rate was defined as the number of intrauterine gestational sacs divided by the number of embryos transferred.|Post Embryo Transfer (PET) Days 21 to 28|Data was not collected since the study was terminated early due to the poor feasibility and sustainability, leading to slow recruitment rate.||||||
2530519|NCT03384316|Secondary|Overall Survival (OS)|OS is defined as the amount of time a subject survives after therapy assessed from the date of first treatment to the date of death (any cause).|up to 12 months||||months||95% Confidence Interval|Median
2530494|NCT03387046|Secondary|Long Term Potentiation Measured by Transcranial Magnetic Stimulation (TMS)|TMS is an electrophysiological technique that was used to measure neurologic changes associated with recovery from stroke via alterations in the excitability of the motor system. Motor threshold measures reflect global excitability of the corticospinal pathway, including large pyramidal cells, excitatory/inhibitory interneurons, and spinal motor neurons. Long term potentiation can be measured non invasively and painlessly, in awake humans through transcranial magnetic stimulation (TMS). TMS uses high intensity, brief duration, magnetic fields that, when applied on the scalp, can activate neurons within a small focal region of the cerebral cortex, through electromagnetic induction. Motor Evoked Potentials (MEP) amplitudes elicited by single TMS pulses of increasing intensity (110, 120 and 130% of the Resting Motor Threshold [RMT]) will be measured to calculate recruitment curves of the motor cortex. Participant wise data was reported for this outcome.|Baseline (0 minute) and Post-Baseline (15 minutes) at Week 8|"Full analysis set. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, Number of participants analyzed signifies those who were evaluated for this endpoint and number analyzed signifies specific participant evaluated in respective arm."|||millivolts|||Number
2530495|NCT03387046|Secondary|Fatigue Severity Scale (FSS) Score to Measure Fatigue by at Week 8, 12 and 24|Fatigue Severity Scale (FSS) is a method of evaluating fatigue in multiple sclerosis and is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue. Participant wise data was reported for this outcome.|Week 8, 12 and 24|"Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, number analyzed signifies specific participant evaluated in respective arm at specified timepoint."|||units on a scale|||Number
2530496|NCT03387046|Secondary|Modified Fatigue Impact Scale (MFIS) Score to Measure Fatigue at Week 8, 12 and 24|MFIS is a structured, self-report questionnaire consisting of 21 items assessing the effects of fatigue. All 21 items are scaled 0 to 4, with higher scores indicating a greater impact of fatigue on participant's activities. The Total MFIS score ranges from 0 to 84. A score of 0 indicates fatigue has no impact on activities and the high-end score indicates fatigue has extreme impact on activities. Participant wise data was reported for this outcome.|Week 8, 12 and 24|"Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, number analyzed signifies specific participant evaluated in respective arm at specified timepoint."|||units on a scale|||Number
2530497|NCT03387046|Secondary|Low Contrast Letter Visual Acuity Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment|Visual acuity is measured under low contrast conditions (10% contrast relative to the chart background) at object testing distances of 10 feets and is reported as the number of letters read correctly (ranging from 0 to 10 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. Participant wise data was reported for this outcome.|Week 8, 12 and 24|"Full analysis set. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, Number of participants analyzed signifies those who were evaluable for this endpoint and number analyzed signifies specific participant evaluated in respective arm at specified timepoint."|||Letters read correctly|eye||Number
2530498|NCT03387046|Secondary|Symbol Digit Modalities Test to Measure Multiple Sclerosis Related Disability and Cognitive Impairment|Symbol digit modalities test is to evaluate neurocognitive functions. This measure involves a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. The participants is required to scan the key and write down the number corresponding to each symbol as fast as possible. The number of correct substitution within 90 seconds is recorded. In the written version of the test the participants fills in the numbers that correspond to the symbols. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates better performance. Participant wise data was reported for this outcome.|At Week 8, 12 and 24|"Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, number analyzed signifies specific participant evaluated in respective arm at specified timepoint."|||units on a scale|||Number
2530499|NCT03387046|Secondary|9 Hole Peg Test (9HPT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment|The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The data for the 29HPT is reported for the 2 completed trials. Participant wise data was reported for this outcome.|Week 8, 12 and 24|"Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, number analyzed signifies specific participant evaluated in respective arm at specified timepoint."|||Seconds|||Number
2530520|NCT03384316|Secondary|Progression-free Survival (PFS)|The amount of time a subject survives without disease progression after treatment. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) and is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum diameters while on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of 5 mm. (Note: the appearance of one or more lesions is also considered progression).|up to 12 months||||weeks||Full Range|Median
2530537|NCT03383627|Primary|Duration Hypoglycemic Events|As monitoring device measures blood glucose level numerous time, duration of hypoglycemic event will be calculated in percent time per subject based on total duration of time subject wore CGM device.|14 Days||||Percentage time with Hypoglycemia||Standard Deviation|Mean
2530500|NCT03387046|Secondary|25-foot Timed Walk (25-FWT) to Measure Multiple Sclerosis Related Disability and Cognitive Impairment|The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The participants is directed to one end of a clearly marked 25-foot (7.62 m) course and is instructed to walk 25 feet (7.62 meter) as quickly as possible, but safely. The task is immediately administered again by having the participant walk back the same distance. Participants may use assistive devices when doing this task. The test scores were the time in seconds it took to walk the 25 feet. The data for the 25-FWT is reported for the 2 completed trials. Participant wise data was reported for this outcome.|At Week 8, 12 and 24|"Full analysis set included all participants enrolled into the study and assigned to the randomized treatment. No summary analysis was done as study was prematurely terminated due to slow recruitment rate and participant wise data are reported. Here, number analyzed signifies specific participant evaluated in respective arm at specified timepoint."|||Seconds|||Number
2530501|NCT03387046|Secondary|Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 12 and 24|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with Multiple Sclerosis. It assesses the 8 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral and other) as well as ambulation. EDSS overall score ranging from 0 (normal) to 10 (death due to MS).|Baseline, Week 12 and 24|Full analysis set included all participants enrolled into the study and assigned to the randomized treatment.|||Participants|||Count of Participants
2530502|NCT03387046|Primary|Number of Participants With Change From Baseline in Multiple Sclerosis Related Disability Measured by Expanded Disability Status Scale (EDSS) at Week 8|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with Multiple Sclerosis (MS). It assesses the 8 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder, cerebral and other) as well as ambulation. EDSS overall score ranging from 0 (normal) to 10 (death due to MS).|Baseline, Week 8|Full analysis set included all participants enrolled into the study and assigned to the randomized treatment.|||Participants|||Count of Participants
2530503|NCT03386474|Secondary|Percentage of Subjects With Positive Anti-drug Antibody (ADA) Status for Brolucuzumab 6 mg in Extension|Positive integrated anti-drug antibodies (ADA) status is defined as induced ADA status with ADA negative at pre-dose and a post-dose titer value of greater than or equal to 30 at any time point or boosted ADA status with ADA positive at pre-dose and a post-dose titer value increase by more than 3-fold (1 dilution) at any time point. Outcome measure was prespecified for brolucizumab arm only. Neither the patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension trial. Data was presented descriptively for only brolucizumab in line with the study objective. No formal hypothesis testing was planned. Missing brolucizumab data were imputed using last observation carried forward (LOCF).|Extension Baseline, Week 8, Week 16, Week 24|Extension Data Set included all subjects who entered extension study and received at least one injection of study treatment. Assessment of efficacy and safety of brolucizumab 6 mg was based on a within-patient comparison with last 6 months of corresponding core-study efficacy data serving as the reference.|||Percentage of participants|||Number
2530504|NCT03386474|Secondary|Change in Central Sub-Field Thickness (CSFT) From Extension Baseline at Each Post-baseline Visit|Measurement of the central subfield thickness of the retina was assessed using Optical Coherence Tomography (OCT) at each visit for the study eye. Outcome measure was prespecified for brolucizumab arm only. Neither the patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension trial. Data was presented descriptively for only brolucizumab in line with the study objective. No formal hypothesis testing was planned. Missing brolucizumab data were imputed using last observation carried forward (LOCF).|Extension Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|Extension Data Set included all subjects who entered extension study and received at least one injection of study treatment. Assessment of the efficacy and safety of brolucizumab 6 mg was based on a within-patient comparison with the last 6 months of corresponding core-study efficacy data serving as the reference.|||micrometer||Standard Deviation|Mean
2530505|NCT03386474|Secondary|Patients With Positive q12w Treatment Status at Week 20|The estimate for the proportion of patients with a positive q12w treatment status at Week 24 was derived from Kaplan Meier time-to-event analyses for the event 'first q8w-need'. The outcome of the Kaplan-Meier analysis was estimated probability for maintaining on q12w up to the Disease Activity Assessment (DAA) at exWeek 20. Outcome measure was prespecified for brolucizumab arm only. Neither the patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension trial. Data was presented descriptively for only brolucizumab in line with the study objective. No formal hypothesis testing was planned. Missing brolucizumab data were imputed using last observation carried forward (LOCF).|Week 20|Extension Data Set included all subjects who entered extension study and received at least one injection of study treatment. Assessment of the efficacy and safety of brolucizumab 6 mg was based on a within-patient comparison with last 6 months of corresponding core-study efficacy data serving as reference.|||Percentage of patients|||Number
2530506|NCT03386474|Secondary|Change in BCVA From Extension Baseline at Each Post-baseline Visit|Best-corrected visual acuity for the study eye was tested at all study visits in a sitting position using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. Outcome measure was prespecified for brolucizumab arm only. Neither the patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension trial. Data was presented descriptively for only brolucizumab in line with the study objective. No formal hypothesis testing was planned. Missing brolucizumab data were imputed using last observation carried forward (LOCF).|Extension baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|Extension Data Set included all subjects who entered extension study and received at least one injection of study treatment. Assessment of the efficacy of brolucizumab 6 mg was based on a within-patient comparison with the last 6 months of corresponding core-study efficacy and safety data serving as the reference.|||Letter read||Standard Deviation|Mean
2531482|NCT03340805|Other Pre-specified|Hospital Length of Stay|Measured as the number of calendar days between ED arrival and ED or hospital discharge (whichever occurs later)|up to 90 days following randomization||||days||Inter-Quartile Range|Median
2530507|NCT03386474|Secondary|Change of Loss in BCVA of 15 Letters or More From Extension Baseline at Each Post-baseline Visit|Best-corrected visual acuity for the study eye was tested at all study visits in a sitting position using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. Outcome measure was prespecified for brolucizumab arm only. Neither patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension trial. Data presented descriptively for only brolucizumab in line with study objective. No formal hypothesis testing was planned. Missing brolucizumab data were imputed using last observation carried forward (LOCF).|Extension Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24|Extension Data Set included all subjects who entered extension study and received at least one injection of study treatment. Assessment of the efficacy and safety of brolucizumab 6 mg was based on a within-patient comparison with the last 6 months of corresponding core study efficacy data serving as the reference.|||Number of Participants|||Number
2530508|NCT03386474|Primary|Number of Participants With Ocular and Non-Ocular Treatment Emergent Adverse Events|Number of participants with ocular and non-ocular treatment emergent events with the new formulation brolucizumab 6 mg in this extension trial up to week 24 vs. the corresponding last 6 months of brolucizumab treatment in the Core trial >= 2%. Safety assessment of the new formulation brolucizumab 6 mg was based on a within-patient comparison with the last 6 months of corresponding Core safety data. Missing brolucizumab data were imputed using last observation carried forward (LOCF).|Up to Week 24|Brolucizumab extension safety set included subjects who received at least one injection of brolucizumab 6mg. Data was presented descriptively for only brolucizumab in line with the study objective. No formal hypothesis testing was planned.|||Participants|||Number
2530509|NCT03386448|Primary|Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period|The Montgomery-Asberg (MADRS) depression scale will be utilized throughout the study. The scale is scored 0-60, 0 signifying no depression symptoms and 60 signifying very severe depression. A diagnosis of depression will be given to a participant in this study for a MADRS score of 20 or greater. A clinical response to medication will be noted when a participant has a 25% or greater decrease in MADRS score during the trial.|Baseline and 4 weeks||||units on a scale||95% Confidence Interval|Mean
2530510|NCT03386435|Secondary|Postoperative Liver Regeneration|The postoperative liver regeneration index (LRI) at postoperative 1 month ) was used as surrogate parameters indicating the possible benefits of RIPC. The LRI was defined as [(VLR − VFLR)/VFLR)] × 100, where VLR is the volume of the liver remnant and VFLR is the volume of the future liver remnant. Liver volume was calculated by CT volumetry using 3-mm-thick dynamic CT images. The graft weight was subtracted from the total liver volume to define the future liver remnant.|1 month||||percentage of liver volume||Inter-Quartile Range|Mean
2530511|NCT03386435|Secondary|Number of Participants With Delayed Recovery of Liver Function|The incidence of delayed recovery of hepatic function (DRHF) were used as surrogate parameters indicating the possible benefits of RIPC. DRHF was defined based on a proposal by the International Study Group of Liver Surgery, as follows: an impaired ability of the liver to maintain its synthetic, excretory, and detoxifying functions, which are characterized by an increased PT INR and concomitant hyperbilirubinemia (considering the normal limits of the local laboratory) on or after postoperative day 5. The normal upper limits of PT and bilirubin in our institutional laboratory were 1.30 INR and 1.2 mg/dL, respectively. If either the PT INR or serum bilirubin concentration was preoperatively elevated, DRHF was defined by an increasing PT INR and increasing serum bilirubin concentration on or after postoperative day 5 (compared with the values of the previous day).|postoperative 7 days||||Participants|||Count of Participants
2530512|NCT03386435|Primary|The Maximal Alanine Aminotransferase Level Within 7 Postoperative Days|The serial assessments of routine laboratory values were used as early markers for postoperative liver function. The maximal alanine aminotransferase level within 7 postoperative days were assessed following RIPC in living donor hepatectomy|within 7 days after operation||||IU/L||Inter-Quartile Range|Mean
2530513|NCT03386435|Primary|Postopera The Maximal Aspartate Aminotransferase Level Within 7 Postoperative Days|The serial assessments of routine laboratory values were used as early markers for postoperative liver function. The maximal aspartate aminotransferase level within 7 postoperative days were assessed following RIPC in living donor hepatectomy.|within 7 days after operation||||IU/L||Inter-Quartile Range|Mean
2530514|NCT03384953|Primary|Change in Pain Intensity|Brief Pain Inventory (severity scale only) is a 4-item subscale of the Brief Pain Inventory assessing the severity of pain over the past week. Questions inquire into an individual's worst, least, average, and current levels of pain on an 11-point likert scale, with 0 being no pain. It has been validated and is considered the gold standard to utilize in patient-reported outcomes studies. It takes <1 minute to complete.|baseline and 6 months|Patients who completed 6-month post-treatment follow-up|||units on a scale||Standard Deviation|Mean
2530515|NCT03384316|Other Pre-specified|Number of Dose Limiting Toxicities (DLTs)|A DLT is defined as any Grade 3 or greater toxicity that is possibly related to the vaccine and as defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 with the exception of transient (≤ 24 hours) Grade 3 flu-like symptoms or fever, which is controlled with medical management (≤ 24 hours) Grade 3 fatigue, skin reactions or rash, headache, nausea, emesis that resolves to Grade ≤ 1 or asymptomatic grade 3 amylase/lipase elevation.|From the date of the first dose of vaccine, approximately 3 weeks.||||Toxicities|||Number
2530516|NCT03384316|Other Pre-specified|Number of Participants With a Positive Brachyury Specific T-Cells Immune Response|Peripheral blood mononuclear cells (PBMC) were analyzed by flow cytometry to evaluate anti-tumor response induced by vaccine injection.|up to week 6||||Participants|||Count of Participants
2530517|NCT03384316|Other Pre-specified|Number of Participants With a Positive Carcinoembryonic Antigen (CEA) Specific T-Cells Immune Response|Peripheral blood mononuclear cells (PBMC) were analyzed by flow cytometry to evaluate anti-tumor response induced by vaccine injection.|up to week 6||||Participants|||Count of Participants
2530518|NCT03384316|Other Pre-specified|Number of Participants With a Positive Mucin-1 (MUC-1) Specific T-Cells Immune Response|Peripheral blood mononuclear cells (PBMC) were analyzed by flow cytometry to evaluate anti-tumor response induced by vaccine injection.|up to week 6||||Participants|||Count of Participants
2546971|NCT02915029|Secondary|Systolic Blood Pressure|Changes in Systolic blood pressure over study.|12 months minus baseline values||||mm Hg||Standard Deviation|Mean
2530521|NCT03384316|Secondary|Number of Patients With Disease Control (Confirmed Response or Stable Disease (SD)) Lasting for at Least 6 Months|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for Progressive Disease (taking as reference the smallest sum diameters while on study).|up to 6 months||||Participants|||Count of Participants
2530522|NCT03384316|Secondary|Number of Participants Who Achieve an Objective Confirmed Complete or Partial Response Assessed by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|Objective response is determined by participants whose tumors shrunk after therapy assessed by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Approximately 3.5 months||||Participants|||Count of Participants
2530523|NCT03384316|Primary|Recommended Phase 2 Dose (RP2D)|RP2D is defined as ≤ 1 of 6 of the initial 6 subjects who experience a dose limiting toxicity (DLT), than this dose level will be defined as the RP2D. A DLT is defined as any Grade 3 or greater toxicity that is possibly related to the vaccine and as defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 with the exception of transient (≤ 24 hours) Grade 3 flu-like symptoms or fever, which is controlled with medical management (≤ 24 hours) Grade 3 fatigue, skin reactions or rash, headache, nausea, emesis that resolves to Grade ≤ 1 or asymptomatic grade 3 amylase/lipase elevation.|RP2D was based upon evaluation of DLTs. Participants were followed for DLTs from the first dose of vaccine for 3 weeks.|RP2D was determined in Dose Level 1 cohort.|||billion viral particles per indiv. vacc.|||Number
2530524|NCT03384316|Primary|Number of Participants With Serious and Non-serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 16 months and 6 days.||||Participants|||Count of Participants
2530525|NCT03383887|Secondary|Collapsibility of the Upper Airway: VPassive|Ventilation when ventilatory drive is relatively low during sleep|1 night||||% eupneic ventilation||Inter-Quartile Range|Median
2530526|NCT03383887|Primary|Apnea Hypopnea Index (AHI, Events/Hour of Sleep)|Based on previous studies the investigators anticipate that DAW1033D will reduce AHI more effectively in subjects with moderate sleep apnea, and mild to moderate pharyngeal collapsibility. AHI describes the frequency of obstruction of the upper airway during sleep and is commonly used to describe the presence and severity of obstructive sleep apnea.|1 night|1 participant was not analyzed because he dropped out between the 2 intervention arms|||events/hour of sleep||Inter-Quartile Range|Median
2530527|NCT03383783|Secondary|Transverse Microradiography (TMR) - Maximum Mineral Density at the Surface-zone|"Lesions will be analyzed after in situ demineralization and the following three parameters calculated:~Integrated Mineral Loss - ∆Z= [(lesion depth x 87) - area under the curve*]~Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel)~Maximum mineral density at the surface-zone - SZmax (arbitrary unit from TMR software)"|Enamel specimens will be evaluated after 14 days of intra-oral exposure||||SZmax||95% Confidence Interval|Mean
2530528|NCT03383783|Secondary|Transverse Microradiography (TMR) - Lesion Depth - L|"Lesions will be analyzed after in situ demineralization and the following three parameters calculated:~Integrated Mineral Loss - ∆Z= [(lesion depth x 87) - area under the curve*]~Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel)~Maximum mineral density at the surface-zone - SZmax"|Enamel specimens will be evaluated after 14 days of intra-oral exposure||||Micrometers||95% Confidence Interval|Mean
2530529|NCT03383783|Secondary|Transverse Microradiography (TMR) - Integrated Mineral Loss - ∆Z|"Lesions will be analyzed after in situ demineralization and the following three parameters calculated:~Integrated Mineral Loss - ∆Z= [(lesion depth x 87) - area under the curve*]~Lesion Depth - L (83% mineral i.e. 95% of the mineral content of sound enamel)~Maximum mineral density at the surface-zone - SZmax"|Enamel specimens will be evaluated after 14 days of intra-oral exposure||||Integrated Mineral Loss - ∆Z||95% Confidence Interval|Mean
2530530|NCT03383783|Secondary|Enamel Fluoride Uptake (EFU)|The amount of fluoride-uptake by enamel will be calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as µg F/cm2.|Enamel specimens will be evaluated after 14 days of intra-oral exposure||||µg F/cm^2||95% Confidence Interval|Mean
2530531|NCT03383783|Secondary|Comparative Acid Resistance (CAR)|"Using the data from the four centrally located enamel specimens, the equation used will compare explicitly the reduction in SMH brought by the first and second acid challenges:~Comparative Acid Resistance = [(D2-R) / (D1-B)] * 100 B= Indentation length (µm) of sound enamel at baseline R= Indentation length (µm) of enamel after in situ remineralization D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization"|Enamel specimens will be evaluated after 14 days of intra-oral exposure||||% Comparative Acid Resistance||95% Confidence Interval|Mean
2530532|NCT03383783|Secondary|Net Acid Resistance (NAR)|"The %NAR will be calculated by the method of Corpron [Corpron et al., 1986]:~Net Acid Resistance = [(D1-D2) / (D1-B)] * 100 B= Indentation length (µm) of sound enamel at baseline D1= Indentation length (µm) after first in vitro demineralization D2= Indentation length (µm) after second in vitro demineralization"|Enamel specimens will be evaluated after 14 days of intra-oral exposure||||% Net Acid Resistance||95% Confidence Interval|Mean
2530533|NCT03383783|Primary|Percentage Surface Microhardness Recovery (%SMH)|"The extent of remineralization will be calculated based on the method of [Gelhard et al., 1979].~SMH recovery = (D1-R)/(D1-B) ×100 B = indentation length (µm) of sound enamel specimen at baseline D1 = indentation length (µm) after in vitro demineralization R = indentation length (µm) after intra-oral exposure."|Enamel specimens will be evaluated after 14 days of intra-oral exposure||||Percent Surface Microhardness Recovery||95% Confidence Interval|Mean
2567569|NCT02565381|Secondary|Study Visit Attendance|Percentage of 14 assessment visits attended.|8 weeks||||percentage of visits||Standard Deviation|Mean
2530539|NCT03383627|Primary|Number of Participants With Hypoglycemic Events|Hypoglycemic event will be considered when blood sugar level is <=70 mg/dl. Detail information like time of event, number of subjects with an event, duration of event will be analyzed.|14 Days||||Participants|||Count of Participants
2530540|NCT03383627|Primary|Mean Glucose Concentration Measured by CGM|Mean glucose concentration (mg/dL) will be measured using measurements taken by CGM device.|14 Days||||mg/dL||Inter-Quartile Range|Mean
2530541|NCT03383614|Other Pre-specified|Drug-related Adverse Events|"Subjects presenting drug-related treatment-emergent adverse events listed by preferred term.~Note: subjects with ≥1 adverse event are counted only once per preferred term."|Drug-related AEs were reported throughout the study|OD=once daily; BID=twice daily.|||Participants|||Number
2530542|NCT03383614|Secondary|Mean Serum Insulin Concentration at Day 120|"Oral glucose tolerance test: mean serum insulin concentration at Day 120, before and up to 4 hours after intake of a high-glucose solution, in subjects receiving repeated doses of emodepside or placebo for 10 days (Days 0-9).~Baseline=pre-glucose intake on each respective day. Note: At Day 120, serum glucose concentration was only measured in Cohort 3 (10 mg BID)"|Mean serum insulin concentration at Day 120, before and up to 4 hours after intake of a high-glucose solution|OD=once daily; BID=twice daily.|||pmol/L||Standard Deviation|Mean
2530543|NCT03383614|Secondary|Mean Serum Insulin Concentration at Day 8|"Oral glucose tolerance test: mean serum insulin concentration at Day 8, before and up to 4 hours after intake of a high-glucose solution, in subjects receiving repeated doses of emodepside or placebo for 10 days (Days 0-9).~Baseline=pre-glucose intake on each respective day."|Mean serum insulin concentration at Day 8, before and up to 4 hours after intake of a high-glucose solution|OD=once daily; BID=twice daily.|||pmol/L||Standard Deviation|Mean
2530544|NCT03383614|Secondary|Mean Serum Insulin Concentration at Day 1|"Oral glucose tolerance test: mean serum insulin concentration at Day 1, before and up to 4 hours after intake of a high-glucose solution, in subjects receiving repeated doses of emodepside or placebo for 10 days (Days 0-9).~Baseline=pre-glucose intake on each respective day."|Mean serum insulin concentration at Day 1, before and up to 4 hours after intake of a high-glucose solution|OD=once daily; BID=twice daily.|||pmol/L||Standard Deviation|Mean
2530545|NCT03383614|Secondary|Mean Serum Insulin Concentration at Day -2|"Oral glucose tolerance test: mean serum insulin concentration at Day -2, before and up to 4 hours after intake of a high-glucose solution, in subjects receiving repeated doses of emodepside or placebo for 10 days (Days 0-9).~Baseline=pre-glucose intake on each respective day."|Mean serum insulin concentration at Day -2, before and up to 4 hours after intake of a high-glucose solution|OD=once daily; BID=twice daily.|||pmol/L||Standard Deviation|Mean
2530546|NCT03383614|Secondary|Mean Serum Glucose Concentration at Day 120|"Oral glucose tolerance test: mean serum glucose concentration at Day 120, before and up to 4 hours after intake of a high-glucose solution, in subjects receiving repeated doses of emodepside or placebo for 10 days (Days 0-9).~Baseline=pre-glucose intake on each respective day. Note: At Day 120, serum glucose concentration was only measured in Cohort 3 (10 mg BID)"|Mean serum glucose concentration at Day 120, before and up to 4 hours after intake of a high-glucose solution|OD=once daily; BID=twice daily.|||mmol/L||Standard Deviation|Mean
2530547|NCT03383614|Secondary|Mean Serum Glucose Concentration at Day 8|"Oral glucose tolerance test: mean serum glucose concentration at Day 8, before and up to 4 hours after intake of a high-glucose solution, in subjects receiving repeated doses of emodepside or placebo for 10 days (Days 0-9).~Baseline=pre-glucose intake on each respective day."|Mean serum glucose concentration at Day 8, before and up to 4 hours after intake of a high-glucose solution|OD=once daily; BID=twice daily.|||mmol/L||Standard Deviation|Mean
2530548|NCT03383614|Secondary|Mean Serum Glucose Concentration at Day 1|"Oral glucose tolerance test: mean serum glucose concentration at Day 1, before and up to 4 hours after intake of a high-glucose solution, in subjects receiving repeated doses of emodepside or placebo for 10 days (Days 0-9).~Baseline=pre-glucose intake on each respective day."|Mean serum glucose concentration at Day 1, before and up to 4 hours after intake of a high-glucose solution|OD=once daily; BID=twice daily.|||mmol/L||Standard Deviation|Mean
2530549|NCT03383614|Secondary|Mean Serum Glucose Concentration at Day -2|"Oral glucose tolerance test: mean serum glucose concentration at Day -2, before and up to 4 hours after intake of a high-glucose solution, in subjects receiving repeated doses of emodepside or placebo for 10 days (Days 0-9).~Baseline=pre-glucose intake on each respective day."|Mean serum glucose concentration at Day -2, before and up to 4 hours after intake of a high-glucose solution|OD=once daily; BID=twice daily.|||mmol/L||Standard Deviation|Mean
2530550|NCT03383614|Secondary|Mean Insulin Concentration at Day 30|Mean insulin concentration (pmol/L) after repeated once or twice daily dosing with up to 10 mg emodepside or placebo at Day 30.|Mean insulin concentration at Day 30 after repeated once or twice daily dosing|OD=once daily; BID=twice daily.|||pmol/L||Standard Deviation|Mean
2530551|NCT03383614|Secondary|Mean Insulin Concentration at Day 9|Mean insulin concentration (pmol/L) after repeated once or twice daily dosing with up to 10 mg emodepside or placebo at Day 9.|Mean insulin concentration at Day 9 after repeated once or twice daily dosing|OD=once daily; BID=twice daily.|||pmol/L||Standard Deviation|Mean
2530552|NCT03383614|Secondary|Mean Insulin Concentration at Day 0|"Mean insulin concentration (pmol/L) after repeated once or twice daily dosing with up to 10 mg emodepside or placebo at Day 0.~Baseline=predose on Day 0."|Mean insulin concentration at Day 0 after repeated once or twice daily dosing|OD=once daily; BID=twice daily.|||pmol/L||Standard Deviation|Mean
2530553|NCT03383614|Secondary|Mean Insulin Concentration at Day -1|Mean insulin concentration (pmol/L) after repeated once or twice daily dosing with up to 10 mg emodepside or placebo at Day -1.|Mean insulin concentration at Day-1 after repeated once or twice daily dosing|OD=once daily; BID=twice daily.|||pmol/L||Standard Deviation|Mean
2530554|NCT03383614|Secondary|Mean Glucose Concentration at Day 30|Mean glucose concentrations (mmol/L) after repeated once or twice daily dosing with up to 10 mg emodepside or placebo at Day 30.|Mean glucose at Day 30 after repeated once or twice daily dosing|OD=once daily; BID=twice daily.|||mmol/L||Standard Deviation|Mean
2530555|NCT03383614|Secondary|Mean Glucose Concentration at Day 9|Mean glucose concentrations (mmol/L) after repeated once or twice daily dosing with up to 10 mg emodepside or placebo at Day 9.|Mean glucose at Day 9 after repeated once or twice daily dosing|OD=once daily; BID=twice daily.|||mmol/L||Standard Deviation|Mean
2535729|NCT03195010|Primary|Number of Patients Approached for But Refusing Consent|Reasons for ineligibility will be reported qualitatively in order to inform future studies.|Up to 1 year||||Participants|||Count of Participants
2530556|NCT03383614|Secondary|Mean Glucose Concentration at Day 0|"Mean glucose concentrations (mmol/L) after repeated once or twice daily dosing with up to 10 mg emodepside or placebo at Day 0.~Baseline=predose on Day 0."|Mean glucose after repeated once or twice daily dosing for up to 10 days|OD=once daily; BID=twice daily.|||mmol/L||Standard Deviation|Mean
2530557|NCT03383614|Secondary|Mean Glucose Concentration at Day -1|Mean glucose concentrations (mmol/L) after repeated once or twice daily dosing with up to 10 mg emodepside or placebo at Day -1.|Mean glucose at Day -1 after repeated once or twice daily dosing|OD=once daily; BID=twice daily.|||mmol/L||Standard Deviation|Mean
2530558|NCT03383614|Secondary|The Rac(Cmax) of Emodepside in Plasma|"Summary of emodepside plasma Rac(Cmax) after 10 days' repeated doses of 10 mg emodepside (Day 9): PK parameter population.~Rac(Cmax): accumulation ratio calculated from Cmax, where Cmax is the observed maximum plasma concentration measured in a subject after dosing identified by inspection of the drug concentration vs. time data.~Note: measure of dispersion is 'percentage coefficient of variation' (the between-subject coefficient of variation [%CVb])."|Rac(Cmax) after 10 days' repeated doses of 10 mg emodepside (Day 9)|OD=once daily; BID=twice daily.|||Ratio||Standard Deviation|Mean
2530559|NCT03383614|Secondary|The Rac(AUC24) of Emodepside in Plasma|"Summary of emodepside plasma Rac(AUC24) after 10 days' repeated doses of 10 mg emodepside (Day 9): PK parameter population.~Rac(AUC24): accumulation ratio calculated from AUC24, where AUC24 is the area under the concentration-time curve from time zero (pre-dose) to 24h.~Note: measure of dispersion is 'percentage coefficient of variation' (the between-subject coefficient of variation [%CVb])."|Rac(AUC24) after 10 days' repeated doses of 10 mg emodepside (Day 9)|OD=once daily; BID=twice daily.|||Ratio||Standard Deviation|Mean
2530560|NCT03383614|Secondary|The Rac(AUC12) of Emodepside in Plasma|"Summary of emodepside plasma Rac(AUC12) after 10 days' repeated doses of 10 mg emodepside (Day 9): PK parameter population.~Rac(AUC12): accumulation ratio calculated from AUC12, where AUC12 is the area under the concentration−time curve from time zero (pre-dose) to 12h.~Note: measure of dispersion is 'percentage coefficient of variation' (the between-subject coefficient of variation [%CVb]).~Note: Rac(AUC12) was calculated only in Cohort 3."|Rac(AUC12) after 10 days' repeated doses of 10 mg emodepside (Day 9)|BID=twice daily.|||Ratio||Standard Deviation|Mean
2530561|NCT03383614|Secondary|The MRTlast of Emodepside in Plasma|"Summary of MRTlast of emodepside after the first (Day 0) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15 h after the morning dose.~MRTlast: mean residence time from time zero (pre-dose) to the time of last quantifiable concentration (measurable up to 24h after dosing on Day 0).~The geometric coefficient of variation is the between-subject coefficient of variation (%CVb)."|MRTlast in plasma after the first (Day 0) dose|OD=once daily; BID=twice daily.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2530562|NCT03383614|Secondary|The Vz/F of Emodepside in Plasma|"Summary of Vz/F of emodepside after the last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose.~Vz/F: apparent volume of distribution on Day 9. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb)."|Vz/F in plasma after the last (Day 9) dose|OD=once daily; BID=twice daily.|||litre(s)||Geometric Coefficient of Variation|Geometric Mean
2530563|NCT03383614|Secondary|The CLss/F of Emodepside in Plasma|"Summary of CLss/F of emodepside after the last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose.~CLss/F: apparent total clearance from plasma on Day 9. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb)."|CLss/F in plasma after the last (Day 9) dose|OD=once daily; BID=twice daily.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2530564|NCT03383614|Secondary|The λz of Emodepside in Plasma|"Summary of λz of emodepside after the last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose.~λz: terminal rate constant. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb)."|λz in plasma after the last (Day 9) dose|OD=once daily; BID=twice daily.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2530565|NCT03383614|Secondary|The t1/2,(0-24) of Emodepside in Plasma|"Summary of t1/2,(0-24) of emodepside after the last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose.~t1/2,(0-24): half-life calculated from the terminal slope of the log concentration-time (0-24h) curve.~The geometric coefficient of variation is the between-subject coefficient of variation (%CVb)."|t1/2,(0-24) in plasma after the last (Day 9) dose|OD=once daily; BID=twice daily.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2530566|NCT03383614|Secondary|The t1/2 of Emodepside in Plasma|"Summary of t1/2 of emodepside after the last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose.~t1/2: terminal half-life. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb)."|t1/2 in plasma after the last (Day 9) dose|OD=once daily; BID=twice daily.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2530567|NCT03383614|Secondary|The Tmax of Emodepside in Plasma|"Summary of tmax of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15 h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose.~tmax: the time at which Cmax was apparent, identified by inspection of the drug concentration vs. time data."|tmax in plasma after the first (Day 0) and last (Day 9) dose|OD=once daily; BID=twice daily.|||Hours||Full Range|Median
2530568|NCT03383614|Secondary|The Ctrough of Emodepside in Plasma|"Summary of Ctrough (log-transformed) of emodepside after last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose.~Ctrough: trough plasma concentration (measured concentration at the end of a dosing interval on Day 9 [taken directly before next administration]) obtained directly from the concentration-time data.~The geometric coefficient of variation is the between-subject coefficient of variation (%CVb)."|Ctrough in plasma after the last (Day 9) dose|OD=once daily; BID=twice daily.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2530569|NCT03383614|Secondary|The Cmax,Norm of Emodepside in Plasma|"Summary of Cmax,norm of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15 h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose.~Cmax,norm: the observed maximum plasma concentration measured in a subject after dosing identified by inspection of the drug concentration vs. time data, corrected for dose and body weight.~The geometric coefficient of variation is the between-subject coefficient of variation (%CVb)."|Cmax,norm in plasma after the first (Day 0) and last (Day 9) dose|OD=once daily; BID=twice daily.|||(ng/mL)*(mg*kg)||Geometric Coefficient of Variation|Geometric Mean
2530570|NCT03383614|Secondary|The Cmax/D of Emodepside in Plasma|"Summary of Cmax/D of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15 h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose.~Cmax/D: the observed maximum plasma concentration measured in a subject after dosing identified by inspection of the drug concentration vs. time data, corrected for dose.~The geometric coefficient of variation is the between-subject coefficient of variation (%CVb)."|Cmax/D in plasma after the first (Day 0) and last (Day 9) dose|OD=once daily; BID=twice daily.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2530571|NCT03383614|Secondary|The Cmax of Emodepside in Plasma|"Summary of Cmax of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15 h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose.~Cmax: the observed maximum plasma concentration measured in a subject after dosing identified by inspection of the drug concentration vs. time data.~The geometric coefficient of variation is the between-subject coefficient of variation (%CVb)."|Cmax in plasma after the first (Day 0) and last (Day 9) dose|OD=once daily; BID=twice daily.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2530572|NCT03383614|Secondary|The AUC24,Norm of Emodepside in Plasma|"Summary of AUC24,norm of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120h (Day 14) after the morning dose.~AUC24,norm: the area under the concentration-time curve from time zero (pre-dose) to 24h corrected by dose and body weight.~The geometric coefficient of variation is the between-subject coefficient of variation (%CVb)."|AUC24,norm in plasma at Day 0 and Day 9|OD=once daily; BID=twice daily.|||(h*ng/mL)/(mg*kg)||Geometric Coefficient of Variation|Geometric Mean
2530573|NCT03383614|Secondary|The AUC24/D of Emodepside in Plasma|"Summary of AUC24/D of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15 h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose.~AUC24/D: the area under the concentration-time curve from time zero (pre-dose) to 24h corrected for dose.~The geometric coefficient of variation is the between-subject coefficient of variation (%CVb)."|AUC24/D in plasma after the first (Day 0) and last (Day 9) dose|OD=once daily; BID=twice daily.|||h*ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2530574|NCT03383614|Secondary|The AUC24 of Emodepside in Plasma|"Summary of AUC24 of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15 h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose.~AUC24: the area under the concentration-time curve from time zero (pre-dose) to 24 h.~The geometric coefficient of variation is the between-subject coefficient of variation (%CVb)."|AUC24 in plasma after the first (Day 0) and last (Day 9) dose|OD=once daily; BID=twice daily.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2530575|NCT03383614|Secondary|The AUC12,Norm of Emodepside in Plasma|"Summary of AUC12,norm of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15 h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120 h (Day 14) after the morning dose.~AUC12,norm: the area under the concentration−time curve from time zero (pre-dose) to 12 h corrected by dose and body weight.~Note: AUC12,norm was calculated only in Cohort 3. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb)."|AUC12,norm in plasma after the first (Day 0) and last (Day 9) dose|BID=twice daily.|||(h*ng/mL)/(mg*kg)||Geometric Coefficient of Variation|Geometric Mean
2535730|NCT03195010|Primary|Number of Eligible Patients Approached for the Study||Up to 1 year||||Participants|||Count of Participants
2530576|NCT03383614|Secondary|The AUC12/D of Emodepside in Plasma|"Summary of AUC12/D of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120h (Day 14) after the morning dose.~AUC12/D: the area under the concentration-time curve from time zero (pre-dose) to 12h, corrected for dose.~Note: AUC12/D was collected only in Cohort 3. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb)."|AUC12/D in plasma after the first (Day 0) and last (Day 9) dose|BID=twice daily.|||h*ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2530577|NCT03383614|Secondary|The AUC12 of Emodepside in Plasma|"Summary of AUC12 of emodepside after the first (Day 0) and last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 0 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 15h after the morning dose. Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120h (Day 14) after the morning dose.~AUC12: the area under the concentration-time curve from time zero (pre-dose) to 12h.~Note: AUC12 was calculated only in Cohort 3. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb)."|AUC12 in plasma after the first (Day 0) and last (Day 9) dose|BID=twice daily.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Least Squares Mean
2530578|NCT03383614|Secondary|The AUClast,Norm of Emodepside in Plasma|"Summary of AUClast,norm of emodepside after the last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120h (Day 14) after the morning dose.~AUClast,norm: the area under the concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration corrected by dose and body weight.~The geometric coefficient of variation is the between-subject coefficient of variation (%CVb)."|AUClast,norm in plasma after the last (Day 9) dose|OD=once daily; BID=twice daily.|||(h*ng/mL)/(mg*kg)||Geometric Coefficient of Variation|Geometric Mean
2530579|NCT03383614|Secondary|The AUClast/D of Emodepside in Plasma|"Summary of AUClast/D of emodepside after the last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120h (Day 14) after the morning dose.~AUClast/D: the area under the concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration corrected for dose.~The geometric coefficient of variation is the between-subject coefficient of variation (%CVb)."|AUClast /D in plasma after the last dose (Day 9)|OD=once daily; BID=twice daily.|||h*ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2530580|NCT03383614|Secondary|The AUClast of Emodepside in Plasma|"Summary of AUClast of emodepside after the last (Day 9) dose for 10-day oral treatment courses in healthy men: PK parameter population.~Data on Day 9 was collected at the following time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 36 (Day 10), 48 (Day 11), 72 (Day 12), 96 (Day 13) and 120h (Day 14) after the morning dose.~AUClast: the area under the concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration.~PK=pharmacokinetic. The geometric coefficient of variation is the between-subject coefficient of variation (%CVb)."|AUClast in plasma after the last dose (Day 9)|OD=once daily; BID=twice daily.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2530581|NCT03383614|Secondary|Geometric Mean Emodepside Plasma Pharmacokinetic Concentration−Time Data During the Repeated Dosing Period|"Summary of geometric mean emodepside plasma pharmacokinetic concentration−time data (ng/mL) during the repeated dosing period (Days 0-9) in healthy men.~Subjects in the 10 mg emodepside BID dosing group had twice-daily doses on Days 0-8 and a single dose on the morning of Day 9. Therefore, the Day 9, 24 h post-dose value was not comparable to the previous value in that dosing group."|From Day 1, pre-dose to Day 9, 24 hours post-dose|OD=once daily; BID=twice daily.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2530582|NCT03383614|Primary|Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Neurological Examination Findings|Abnormal or clinically significant neurological examination findings during the study or reported as an adverse event.|up to 120 days|"Neurological examinations were measured pre-dose on Day -1, at regular time points until Follow-up (Day 30), and at each long-term follow-up visit.~OD=once daily; BID=twice daily."|||Participants|||Number
2530583|NCT03383614|Primary|Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Physical Examination Findings|Abnormal or clinically significant physical examination findings during the study or reported as an adverse event.|up to 120 days|"Physical and neurological examinations were measured pre-dose on Day -1, at regular time points until Follow-up (Day 30), and at each long-term follow-up visit. Results are reported for subjects experiencing abnormal result/AE, as opposed to individual events.~OD=once daily; BID=twice daily."|||Participants|||Number
2530584|NCT03383614|Primary|Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Ophthalmology Assessment Findings|Ophthalmological examinations at Screening Visit 2 and Day 10 were done at a specialist eye hospital by a Consultant Ophthalmologist, or their assistant. Examinations included: ocular symptoms and history, autorefraction, best correct visual acuity, colour vision, Amsler grid, ocular alignment and motility, confrontation visual field, slit-lamp, measurement of intraocular pressure and an optical coherence tomography test.|up to 10 days|"Ophthalmological assessments were performed at the second screening visit after all other eligibility criteria had been met and on Day 10.~OD=once daily; BID=twice daily."|||Participants|||Number
2530585|NCT03383614|Primary|Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Clinical Laboratory Tests Findings|Clinical laboratory parameters included clinical chemistry, hematology, coagulation and urinalysis.|up to 120 days|"Clinical laboratory parameters were measured pre-dose on Day -1, at regular time points until Follow-up (Day 30), and at each long-term follow-up visit.~OD=once daily; BID=twice daily."|||Participants|||Number
2530707|NCT03379740|Primary|Peak Plasma Nicotine Concentration [cCpeak]|To measure background-corrected peak plasma nicotine concentration [cCpeak] from 60 minutes of ad libitum use.|From Day -1 (baseline) to Day 4||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2530586|NCT03383614|Primary|Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With 12-lead Electrocardiogram Findings|The following variables were recorded in 12-lead ECGs: ventricular rate, PR interval, QRS interval, QTcB and QTcF interval.|up to 30 days|"Twelve-lead ECG assessments were made predose on Day −1 and at regular timepoints until Follow-up (Day 30).~ECG=electrocardiogram; OD=once daily; BID=twice daily; PR=PR interval."|||Participants|||Number
2530587|NCT03383614|Primary|Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Vital Signs Findings|Vital signs included heart rate, systolic and diastolic blood pressure and temperature.|up to 120 days|"Vital signs were measured pre-dose on Day -1, at regular time points until Follow-up (Day 30), and at each long-term follow-up visit.~OD=once daily; BID=twice daily; HR=heart rate; BP=blood pressure."|||Participants|||Number
2530588|NCT03383614|Primary|Safety and Tolerability of Emodepside After Multiple Doses as Measured by Adverse Event Severity|Number of subjects with a TEAE, by highest level of severity.|Up to 120 days|"Adverse events were determined in the Safety population. Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).~AE=adverse event; OD=once daily; BID=twice daily."|||Participants|||Number
2530589|NCT03383614|Primary|Safety and Tolerability of Emodepside After Multiple Doses as Measured by Number of Participants With Adverse Events|Death, serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs).|up to 120 days|"Adverse events were determined in the Safety population. Adverse events were monitored from Screening (Day -28 and until Day -3) to Follow-up (up to Day 120 ±2 days).~AE=adverse event; OD=once daily; BID=twice daily."|||Participants|||Number
2530590|NCT03383588|Primary|Amount of Supplemental Oxycodone Used|Cumulative opioid pain medication used in the first 24 hours postoperatively as recorded in the medical record|4-24 hours post operative|all patients|||mg of supplemental oxycodone||Full Range|Mean
2530591|NCT03383523|Secondary|Safety and Tolerability as Measured by Number of Participants With Clinical Laboratory Tests Findings|number of participants with relevant abnormal laboratory tests results|7 days||||participants|||Number
2530592|NCT03383523|Secondary|Safety and Tolerability as Measured by Number of Participants With 12-lead ECG Findings|number of participants with 12-lead ECG findings. The ECG reference ranges used are the following: ventricular rate: 45-100beats/min, PR interval:120-220msec, QRS:<120msec, QTc:<430msec|7 days||||participants|||Number
2530593|NCT03383523|Secondary|Safety and Tolerability as Measured by Number of Participants With Vital Signs Findings|number of participants with vital signs (VS) findings. The vital signs ranges are the following Supine Systolic BP : 85-160mm HG, Supine Diastolic BP: 40-90mm HG, Supine HR: 35-100 beats/min. Details are described in the protocol section 8.11.2|7 days||||participants|||Number
2530594|NCT03383523|Secondary|Safety and Tolerability as Measured by Number of Participants With Neurological Examination Findings|Number of participants with abnormal neurological examination (NE) findings|7 days||||participants|||Number
2530595|NCT03383523|Secondary|Safety and Tolerability as Measured by Number of Participants With Physical Examination Findings|number of participants with abnormal physical examination (PE) findings. Standard examination done on head, ears, eyes, nose, thyroid, lymph node, back, neck, lungs, skin, abdomen, chest. The details are listed in protocol section 8.11.3|7 days||||participants|||Number
2530596|NCT03383523|Secondary|Safety and Tolerability as Measured by Number of Participants With Treatment-related Adverse Events|number of participants with treatment-related adverse events|7 days||||Participants|||Count of Participants
2530597|NCT03383523|Primary|PK (Cmax) of Two New Tablet Formulations of Emodepside in Comparison to the Liquid Formulation (LSF) Oral Solution.|Cmax means maximum observed plasma concentration. To create the PK curve, the following PK timepoints have been collected: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3,4,6,8,12,36,48,72,120 and 168h post dose|7 days||||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2530598|NCT03383523|Primary|PK (AUC0-7d) of Two New Tablet Formulations of Emodepside in Comparison to the Liquid Formulation (LSF) Oral Solution.|Means AUC from zero to 7 days (AUC0-7d) = means area under the plasma concentration-time curve from time zero (pre-dose) to 7 days. To create the curve, the following PK Timepoints have been collected: pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3,4,6,8,12,36,48,72,120 and 168h post dose|means from zero to 7 days||||h.ng/ml||Geometric Coefficient of Variation|Geometric Mean
2530599|NCT03382834|Secondary|Change From Baseline in Total HIV-1 DNA Levels in CD4+ T Cells|Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value of Total HIV-1 DNA on Day 38 (5 hours post vorinostat) minus the value at baseline.|Pre-entry, entry, and Day 38|Efficacy Population|||log10 copies/million CD4 cells||95% Confidence Interval|Mean
2530600|NCT03382834|Secondary|Number of Participants With HIV-1 RNA Levels (Measured by Single Copy Assay) Greater or Equal to the Lower Limit of Quantification|Number of participants with HIV-1 RNA levels measured by single copy assay (SCA) greater or equal to the lower limit of quantification (LOQ). The lower limit of quantification for this study was 0.47 copies/mL.|Pre-entry, entry, Day 28, Day 35, Day 38 (5 hours post vorinostat), Day 45, Day 65|Efficacy population|||Participants|||Count of Participants
2530601|NCT03382834|Primary|Change From Baseline in Cell-associated HIV-1 RNA in CD4+ T Cells|Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value of Cell-associated HIV-1 RNA on Day 38 (5 hours post vorinostat) minus the value at baseline.|Pre-entry, entry, and Day 38|Efficacy population|||log10 copies/million CD4 cells||95% Confidence Interval|Mean
2530602|NCT03382834|Primary|Proportion of Participants With New Grade 3 or Greater Adverse Events|Proportion of participants with new Grade 3 or greater adverse events that are considered definitely, probably, or possibly related to study treatment (as judged by the core protocol team). The DAIDS AE Grading Table (corrected Version 2.1, July 2017) was used.|Measured from study entry through Day 65|Enrolled participants who were exposed to study treatment|||proportion of participants||95% Confidence Interval|Number
2530603|NCT03382262|Primary|Total Number of Treatment Emergent Adverse Events|Analyses of adverse events (AE) were performed for events considered treatment-emergent (TE). TE was defined as any AE with onset after administration of the 1st dose of study drug or any event present at baseline but worsened in intensity through the study. Severity was graded by the PI using the Common Terminology Criteria for AEs Version 4.0. Grading went from Grade 1 (Mild) to Grade 5 (Death Related to AE).|12 Weeks|All patients randomized to receive either FX006 or TAcs in the hip or shoulder.|||Events|||Number
2530604|NCT03382262|Primary|Concentration of Triamcinolone Acetonide (TA) in Blood Plasma|"Characterize the Pharmacokinetic Profile of FX006 and TCA IR [Time Frame: Day 1 (pre-treatment,1, 2, 3, 4, 5, 6, 8,10, and 12 hrs. post-dose) and Days 2, 3, 5, 8, 15, 22, 29, 57,and 85]~For the PK analysis and individual concentration vs. time plots, a concentration that is BLOQ is assigned a value of zero if it occurs in a profile before the first measurable concentration. If a BLOQ value occurs after a measurable concentration in a profile and is followed by a value above the lower limit of quantification, then the BLOQ is treated as missing data. If a BLOQ value occurs at the end of the collection interval (after the last quantifiable concentration) it is set to zero. If two BLOQ values occur in succession after Cmax, the profile is deemed to have terminated at the first BLOQ value and any subsequent concentrations are set to zero for PK calculations"|12 Weeks|All patients in the Safety population who received study drug, completed scheduled sampling and had sufficient plasma concentration data. 50 of 55 patients were included. Four unique patients for whom hip was the index joint were excluded due to IP administration deviations. One of the four was also found to be enrolled at 2 separate study centers.|||pg/mL||95% Confidence Interval|Geometric Mean
2530605|NCT03381989|Primary|Safety Endpoint is Freedom From Major Adverse Clinical Events (MACE)|Freedom from major adverse clinical events (MACE) according to Valve Academic Research Consortium (VARC-2) at 30days.|30 days|Subjects who underwent the BASILICA procedure|||Participants|||Count of Participants
2530606|NCT03381989|Primary|Procedure Success, Measured at Exit From the Catheterization Laboratory|Successful BASILICA traversal and laceration; immediate survival; successful first TAVR device implantation; absence of coronary artery obstruction; and freedom from emergency cardiac surgery or reintervention related to the BASILICA or TAVR procedure.|1 day|Subjects who underwent the BASILICA procedure|||participants|||Number
2530607|NCT03381742|Secondary|Number of Participants With New-onset Dyspnea|New-onset dyspnea in patients without previous history of dyspnea|up to 5 days||||Participants|||Count of Participants
2530608|NCT03381742|Secondary|Number of Participants With Cardiovascular Event (Cardiovascular Death, New-onset Myocardial Infarction, or Stroke)|Cardiovascular death was defined as sudden cardiac death, fatal myocardial infarction, death due to heart failure, or death due to other cardiovascular causes. Stroke was defined as the focal loss of neurologic function caused by an ischemic or a hemorrhagic event with residual symptoms lasting at least 24 hours or eventually leading to death.|up to 5 days||||Participants|||Count of Participants
2530609|NCT03381742|Secondary|Number of Participants With High On-Treatment Platelet Reactivity (HTPR)|HTPR was defined as IPA ≤ 30% and MA ≥ 47 mm.|up to 5 days||||Participants|||Count of Participants
2530610|NCT03381742|Secondary|ADP-induced Platelet-fibrin Clot Strength (MA)|The physical properties of samples were analyzed using Thromboelastography (TEG) Hemostasis Analyzer (CFMS LEPU-8800, Lepu Medical Technology Co., Ltd, Beijing, China) and automated analytical software. TEG test used four channels to detect the effects of anti-platelet therapy via the arachidonic acid (AA) and ADP pathways. TEG test results were expressed in terms of ADP-induced platelet-fibrin clot strength (MA). A MA>47mm was shown to have a high predictive value for 3-year post-PCI ischemic events during dual antiplatelet therapy. Moreover, ROC curve and quartile analysis suggested MA<31 mm as a predictive value for post-PCI bleeding events (J Am Coll Cardiol. 2013;62(24):2261-73. doi: 10.1016/j.jacc.2013.07.101.).|up to 5 days||||mm||Inter-Quartile Range|Median
2530611|NCT03381742|Primary|Number of Participants With Bleeding (Major or Minor Bleeding)|Major bleeding was defined as type ≥ 3 and minor bleeding as types 1 and 2, in accordance to the Bleeding Academic Research Consortium classification. (Mehran R et al. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449.)|up to 5 days||||Participants|||Count of Participants
2530612|NCT03381742|Primary|ADP-induced Inhibition of Platelet Aggregation|The venous blood samples for platelet function test were drawn after an overnight fast, at 12 hours post-last study-drug dose for subjects receiving twice-daily administrations, and at 24 hours post-last study-drug dose for subjects treated with once-daily regimens. The blood was collected in an evacuated vacuum tube containing 3.2% trisodium citrate and lithium heparin. Then the samples were processed within two hours of blood draw according to standard operating procedure. The physical properties of samples were analyzed using Thromboelastography (TEG) Hemostasis Analyzer (CFMS LEPU-8800, Lepu Medical Technology Co., Ltd, Beijing, China) and automated analytical software. TEG test used four channels to detect the effects of anti-platelet therapy via the arachidonic acid (AA) and ADP pathways. TEG test results were expressed in terms of ADP-induced inhibition of platelet aggregation (IPA, range 0% - 100%), with higher values indicating greater platelet inhibition.|up to 5 days||||percentage of inhibition of platelet agg||Inter-Quartile Range|Median
2530613|NCT03380845|Secondary|Comparing Intensity of Pain With the Different Lasers|Patients will also be evaluated the intensity of pain using a visual analogue scale (0 = absence of pain, 10 = most-severe pain). Higher score means worse outcome|treatment visit 1, treatment visit 2, treatment visit 3|There were 4 participants enrolled and treated, the participants received bilateral facial treatments with Fraxel on one side of the face, and Fractora on the other side of the face|||score on a scale|side of face treated|Full Range|Mean
2530614|NCT03380845|Secondary|Comparing Side Effects of the Different Lasers|measure side effects by patient reported adverse events and blinded physician assessment of adverse effects. Parameters, include erythema, edema, blistering, crusting, scarring, hypopigmentation, and hyperpigmentation, will be graded on a 4-point scale (0 = absent, 1= mild, 2 = moderate, and 3 = severe). Higher score means worse outcome.|treatment visit 1, treatment visit 2, treatment visit 3, three months after last treatment|There were 4 participants enrolled and treated, the participants received bilateral facial treatments with Fraxel on one side of the face, and Fractora on the other side of the face|||score on a scale|side of face treated|Full Range|Mean
2530615|NCT03380845|Primary|Improvement in Acne Scarring - From Baseline to Three Months After Last Treatment|Improvement in acne scarring will be measured by two blinded evaluators both by in-person assessments and by photographic review (digital photography will be used under standardized conditions). A quartile grading scale (1 = 1% to 25%, 2 =26% to 50%, 3 =51% to 75%, 4 = >76% improvement) will be used to measure acne scar improvement. Higher score means better outcome.|three months after last treatment|There were 4 participants enrolled and treated, the participants received bilateral facial treatments with Fraxel on one side of the face, and Fractora on the other side of the face|||score on a scale|side of face treated|Full Range|Mean
2530616|NCT03380780|Secondary|Number of Participants With Concomitant Medications|The original terms recorded by the investigator for concomitant medications were standardized by the sponsor by assigning preferred terms. The duration of treatment with the concomitant medications ranged from 1 day to 5 days. Except for 1 participant who was treated during the in-clinic period (Days -1 to 4), all other concomitant medications were recorded during the ambulatory period (Days 6 to 113).|From screening to study completion (20 weeks)|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||Participants|||Count of Participants
2530617|NCT03380780|Secondary|Change From Baseline in ECG Results by Timepoint: RR Duration|The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.|Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||millisecond||Standard Deviation|Mean
2530618|NCT03380780|Secondary|Change From Baseline in ECG Results by Timepoint: QTcF Duration (Fridericia's Correction Formula)|The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.|Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||millisecond||Standard Deviation|Mean
2530619|NCT03380780|Secondary|Change From Baseline in ECG Results by Timepoint: QTcB Duration (Bazett's Correction Formula)|The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.|Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113||||millisecond||Standard Deviation|Mean
2530620|NCT03380780|Secondary|Change From Baseline in ECG Results by Timepoint: QT Duration|The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.|Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||millisecond||Standard Deviation|Mean
2530621|NCT03380780|Secondary|Change From Baseline in ECG Results by Timepoint: QRS Duration|The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.|Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||millisecond||Standard Deviation|Mean
2530622|NCT03380780|Secondary|Change From Baseline in ECG Results by Timepoint: PR Duration|The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.|Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||millisecond||Standard Deviation|Mean
2530702|NCT03379740|Secondary|Background-corrected Maximum Plasma Concentration [cCmax]|To measure the background-corrected maximum plasma concentration [cCmax] of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen.|From Day -1 (baseline) to Day 4||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2530623|NCT03380780|Secondary|Change From Baseline in Electrocardiogram (ECG) Results by Timepoint: Heart Rate|The 12-lead electrocardiogram (ECG) measurements were collected in triplicate (three consecutive interpretable ECGs within 5 minutes) after the participant had been in a supine position for at least 10 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.|Baseline and Days 2, 4, 6, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||beats per minute||Standard Deviation|Mean
2530624|NCT03380780|Secondary|Change From Baseline in Vital Signs by Timepoint: Temperature (Axillary)|Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.|Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||degrees Celsius (C)||Standard Deviation|Mean
2530625|NCT03380780|Secondary|Change From Baseline in Vital Signs by Timepoint: Systolic Blood Pressure|Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.|Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2530626|NCT03380780|Secondary|Change From Baseline in Vital Signs by Timepoint: Respiratory Rate|Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.|Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||breaths per minute||Standard Deviation|Mean
2530627|NCT03380780|Secondary|Change From Baseline in Vital Signs by Timepoint: Pulse Rate|Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.|Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||beats per minute||Standard Deviation|Mean
2530628|NCT03380780|Secondary|Change From Baseline in Vital Signs by Timepoint: Diastolic Blood Pressure|Vital signs were measured prior to blood sampling while the participant was in a supine position after they had been resting for at least 5 minutes. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last value prior to initiation of study drug.|Baseline and Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2530629|NCT03380780|Secondary|Number of Participants by Test Results for Protein in Urine by Timepoint|Urine samples were collected from participants at the indicated timepoints for evaluation of urinalysis parameters. The number of participants with test results for protein in urine of 0 (Absent), +1 (Trace), +2 (Positive), and +3/+4 (Strong Positive) at baseline and each timepoint are reported. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 8, 29, 57, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||Participants|||Count of Participants
2530708|NCT03379740|Primary|Plasma Nicotine Concentration Versus Time Profile|To measure total and background-corrected plasma nicotine concentration versus time profiles from 60 minutes of ad libitum use.|From Day -1 (baseline) to Day 4||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2530630|NCT03380780|Secondary|Number of Participants by Test Results for Glucose in Urine by Timepoint|Urine samples were collected from participants at the indicated timepoints for evaluation of urinalysis parameters. The number of participants with test results for glucose in urine of 0 (Absent), +1 (Trace), +2 (Positive), and +3/+4 (Strong Positive) at baseline and each timepoint are reported. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 8, 29, 57, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||Participants|||Count of Participants
2530631|NCT03380780|Secondary|Number of Participants by Test Results for Blood in Urine by Timepoint|Urine samples were collected from participants at the indicated timepoints for evaluation of urinalysis parameters. The number of participants with test results for blood in urine of 0 (Absent), +1 (Trace), +2 (Positive), and +3/+4 (Strong Positive) at baseline and each timepoint are reported. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 8, 29, 57, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||Participants|||Count of Participants
2530632|NCT03380780|Secondary|Change From Baseline in Hematology Laboratory Test Results by Timepoint: White Blood Cell Count|Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||*10^9 cells per Liter||Standard Deviation|Mean
2530633|NCT03380780|Secondary|Change From Baseline in Hematology Laboratory Test Results by Timepoint: Red Blood Cell Count|Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||*10^12 cells per Liter||Standard Deviation|Mean
2530634|NCT03380780|Secondary|Change From Baseline in Hematology Laboratory Test Results by Timepoint: Platelet Count|Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||*10^9 cells per Liter||Standard Deviation|Mean
2530635|NCT03380780|Secondary|Change From Baseline in Hematology Laboratory Test Results by Timepoint: Total Neutrophils, Absolute Count|Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||*10^9 cells per Liter||Standard Deviation|Mean
2530636|NCT03380780|Secondary|Change From Baseline in Hematology Laboratory Test Results by Timepoint: Monocytes, Absolute Count|Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||*10^9 cells per Liter||Standard Deviation|Mean
2530679|NCT03380780|Primary|Maximum Observed Plasma Concentration (Cmax) of Emicizumab|Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.|Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113|The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.|||microgram per milliliter (μg/mL)||Standard Deviation|Mean
2530680|NCT03380572|Secondary|Morbidity Data||30 days||||Participants|||Count of Participants
2530637|NCT03380780|Secondary|Change From Baseline in Hematology Laboratory Test Results by Timepoint: Lymphocytes, Absolute Count|Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||*10^9 cells per Liter||Standard Deviation|Mean
2530638|NCT03380780|Secondary|Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hemoglobin Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||gram per Liter (g/L)||Standard Deviation|Mean
2530639|NCT03380780|Secondary|Change From Baseline in Hematology Laboratory Test Results by Timepoint: Hematocrit (as a Fraction of 1)|Hematocrit is a measure of the ratio of red blood cells (RBCs) in the blood by volume. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||ratio of RBCs in blood (L/L)||Standard Deviation|Mean
2530640|NCT03380780|Secondary|Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin Concentration|Erythrocyte mean corpuscular hemoglobin concentration (MCHC) is a measure of the average concentration of hemoglobin per red blood cell. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||gram per Liter (g/L)||Standard Deviation|Mean
2530641|NCT03380780|Secondary|Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Volume|Erythrocyte mean corpuscular volume is a measure of the average volume of a red blood cell. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||femtoliter (fL)||Standard Deviation|Mean
2530642|NCT03380780|Secondary|Change From Baseline in Hematology Laboratory Test Results by Timepoint: Erythrocyte Mean Corpuscular Hemoglobin|Erythrocyte mean corpuscular hemoglobin (MCH) is a measure of the average amount of hemoglobin per red blood cell. Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||picogram per cell||Standard Deviation|Mean
2530681|NCT03380572|Primary|Operative Time||1 day||||minutes||Inter-Quartile Range|Median
2530703|NCT03379740|Secondary|Total and Background-corrected Plasma Nicotine Concentration Versus Time Profiles|To measure the total and background-corrected plasma nicotine concentration versus time profiles of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen.|From Day -1 (baseline) to Day 4||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2530704|NCT03379740|Primary|Background-corrected Average of Plasma Nicotine Concentration [cCaverage]|To measure background-corrected average of plasma nicotine concentration between 0 to 1 hour [cCaverage] from 60 minutes of ad libitum use.|From Day -1 (baseline) to Day 4||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2530643|NCT03380780|Secondary|Change From Baseline in Hematology Laboratory Test Results by Timepoint: Eosinophils, Absolute Count|Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||*10^9 cells per Liter||Standard Deviation|Mean
2530644|NCT03380780|Secondary|Change From Baseline in Hematology Laboratory Test Results by Timepoint: Basophils, Absolute Count|Blood samples were collected from participants at the indicated timepoints for evaluation of hematology parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||*10^9 cells per Liter||Standard Deviation|Mean
2530645|NCT03380780|Secondary|Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time/International Normalized Ratio (INR)|The INR is a standardized measure of the prothrombin time. Blood samples were collected from participants at the indicated timepoints for evaluation of coagulation parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 11, 29, 57 and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||INR of prothrombin time (sec/sec)||Standard Deviation|Mean
2530646|NCT03380780|Secondary|Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Prothrombin Time|Blood samples were collected from participants at the indicated timepoints for evaluation of coagulation parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 11, 29, 57 and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||second||Standard Deviation|Mean
2530647|NCT03380780|Secondary|Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Fibrinogen Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of coagulation parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 11, 29, 57 and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||gram per Liter (g/L)||Standard Deviation|Mean
2530648|NCT03380780|Secondary|Change From Baseline in Coagulation Laboratory Test Results by Timepoint: Activated Partial Thromboplastin Time|Blood samples were collected from participants at the indicated timepoints for evaluation of coagulation parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 11, 29, 57, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||second||Standard Deviation|Mean
2530649|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Uric Acid Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||micromole per Liter (μmol/L)||Standard Deviation|Mean
2537934|NCT03118843|Secondary|Percentage of Participants With HCV RNA < LLOQ On Treatment||Weeks 2, 4, 8, and 12|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2530650|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Triglycerides Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||millimole per Liter (mmol/L)||Standard Deviation|Mean
2530651|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Sodium Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||millimole per Liter (mmol/L)||Standard Deviation|Mean
2530652|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGPT/ALT Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug. SGPT/ALT = serum glutamic-pyruvic transaminase/alanine transaminase|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||unit per Liter (U/L)||Standard Deviation|Mean
2530653|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: SGOT/AST Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug. SGOT/AST = serum glutamic-oxaloacetic transaminase/aspartate transaminase|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||unit per Liter (U/L)||Standard Deviation|Mean
2530654|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Total Protein Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||gram per Liter (g/L)||Standard Deviation|Mean
2530655|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Potassium Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||millimole per Liter (mmol/L)||Standard Deviation|Mean
2530656|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Lactate Dehydrogenase Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||unit per Liter (U/L)||Standard Deviation|Mean
2530657|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Gamma Glutamyl Transferase Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||unit per Liter (U/L)||Standard Deviation|Mean
2530658|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Direct Bilirubin Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||micromole per Liter (μmol/L)||Standard Deviation|Mean
2530659|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatinine Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||micromole per Liter (μmol/L)||Standard Deviation|Mean
2530660|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Creatine Kinase Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||unit per Liter (U/L)||Standard Deviation|Mean
2530661|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Cholesterol Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||millimole per Liter (mmol/L)||Standard Deviation|Mean
2530662|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Chloride Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||millimole per Liter (mmol/L)||Standard Deviation|Mean
2530663|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: C-Reactive Protein Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||milligram per Liter (mg/L)||Standard Deviation|Mean
2530664|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Blood Urea Nitrogen Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||millimole per Liter (mmol/L)||Standard Deviation|Mean
2530665|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Fasting Blood Glucose Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||millimole per Liter (mmol/L)||Standard Deviation|Mean
2530666|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Bilirubin Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||micromole per Liter (μmol/L)||Standard Deviation|Mean
2530667|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Alkaline Phosphatase Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||unit per Liter (U/L)||Standard Deviation|Mean
2530668|NCT03380780|Secondary|Change From Baseline in Clinical Chemistry Laboratory Test Results by Timepoint: Albumin Concentration|Blood samples were collected from participants at the indicated timepoints for evaluation of clinical chemistry parameters. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. The post-baseline minimum and maximum change from baseline values are, respectively, the smallest and largest value changes obtained after baseline through the last study visit, including repeat and unscheduled tests. Baseline was defined as the participant's last sample prior to initiation of study drug.|Baseline and Days 2, 4, 8, 15, 29, 43, 57, 71, 85, and 113|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||gram per Liter (g/L)||Standard Deviation|Mean
2530669|NCT03380780|Secondary|Number of Participants With Laboratory Test Abnormalities|The number of participants with a laboratory abnormality during treatment (numerator) is reported among the 'number analyzed' in the table below (denominator), which represents the number of participants without that abnormality at baseline (last observation prior to initiation of study drug). Note that samples from all participants were analyzed for each laboratory parameter. Values falling above or below the Roche predefined standard reference range were laboratory abnormalities labelled accordingly as 'high' or 'low'. Not every laboratory abnormality qualified as an adverse event; only if it was accompanied by clinical symptoms, resulted in a change in study treatment or in a medical intervention, or was clinically significant in the investigator's judgment. SGOT/AST = serum glutamic-oxaloacetic transaminase/aspartate transaminase; SGPT/ALT = serum glutamic-pyruvic transaminase/alanine transaminase|Baseline and Days 2, 4, 8, 11, 15, 29, 43, 57, 71, 85, and 113|Safety analysis population. The number analyzed in the table below represents the number of participants without the specified laboratory abnormality at baseline. Samples from all participants were analyzed for each laboratory parameter.|||Participants|||Count of Participants
2530682|NCT03380429|Secondary|Percentage of Participants Who Have Either an ACT Total Score of >=20 and/or an Increase From Baseline >=3 in ACT Total Score at Month 6|The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. Baseline value was the latest assessment prior to randomization (Day 1, pre-dose). Percentage of participants who had either an ACT total score of >=20 and/or an increase from Baseline >=3 in ACT total score at Month 6 is presented.|Baseline and Month 6|ITT Population|||Percentage of participants|||Number
2530670|NCT03380780|Secondary|Number of Participants Testing Negative or Positive for the Presence of Anti-Drug Antibodies (ADA) Against Emicizumab by Timepoint and for the Overall Study|Participants were considered to be 'ADA Negative (Treatment Unaffected)' if baseline and all post-baseline samples were negative, or if they were ADA positive at baseline but did not have any post-baseline samples with a titer that was at least 4-fold greater than the titer of the baseline sample. 'Total ADA Positive' is the sum of all participants who tested positive for ADA in the 2 following categories: 'ADA Positive (Treatment Induced)', those who were ADA negative at baseline and tested positive for ADA following study drug administration; and 'ADA Positive (Treatment Boosted)', those who were pre-dose ADA positive and had post-baseline samples with a titer that was at least 4-fold greater compared to the baseline measurement.|Predose at Baseline (Day 1) and postdose on Days 57 and 113|Includes participants with at least one predose and one postdose anti-drug antibody (ADA) assessment.|||Participants|||Count of Participants
2530671|NCT03380780|Secondary|Number of Participants With Adverse Events by Highest World Health Organization (WHO) Toxicity Grade|The WHO Toxicity Grading Scale was used for assessing adverse event severity. Any adverse event not specifically listed in the WHO Toxicity Grading Scale was assessed according to the following levels of severity: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe; and Grade 4 is life-threatening. Investigator text for adverse events were encoded using the Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. After informed consent had been obtained but prior to initiation of study drug, only serious adverse events (SAEs) caused by a protocol-mandated intervention were to have been reported. After initiation of study drug, all adverse events, regardless of relationship to study drug, were to have been reported until the participant completed his last study visit. After this period, any SAEs believed to be related to prior study drug treatment were to be reported.|From screening to study completion (20 weeks)|The safety analysis population included all participants who had received any amount of study medication, whether prematurely withdrawn from the study or not, and with at least one post-baseline safety assessment.|||Participants|||Count of Participants
2530672|NCT03380780|Secondary|Mean Residence Time (MRT) of Emicizumab|Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.|Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113|The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.|||day||Standard Deviation|Mean
2530673|NCT03380780|Secondary|Apparent Volume of Distribution (Vz/F) of Emicizumab|Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.|Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113|The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.|||mL||Standard Deviation|Mean
2530674|NCT03380780|Secondary|Apparent Clearance (CL/F) of Emicizumab|Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.|Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113|The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.|||milliliter per day (mL/day)||Standard Deviation|Mean
2530675|NCT03380780|Secondary|Apparent Terminal Half-Life (t1/2) of Emicizumab|Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.|Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113|The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.|||day||Standard Deviation|Mean
2530676|NCT03380780|Secondary|Time to Cmax (Tmax) of Emicizumab|Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.|Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113|The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.|||day||Full Range|Median
2530677|NCT03380780|Secondary|AUC Between Time Zero and the Time of Last Quantifiable Concentration (AUC0-last) of Emicizumab|Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.|Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113|The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.|||μg*day/mL||Standard Deviation|Mean
2530678|NCT03380780|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) Between Time Zero Extrapolated to Infinity (AUC0-inf) of Emicizumab|Plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Pharmacokinetics (PK) parameters were estimated using standard non-compartmental methods.|Predose on Day 1 and postdose on Days 2, 4, 6, 8, 11, 15, 22, 29, 36, 43, 50, 57, 71, 85, and 113|The pharmacokinetics (PK) analysis population included all enrolled participants; participants were planned to be excluded if they deviated significantly from the protocol or if data was unavailable or incomplete which may influence the PK analysis.|||μg*day/mL||Standard Deviation|Mean
2530700|NCT03379740|Secondary|Background-corrected Area Under the Concentration-time Curve [cAUC(0-4h)]|To measure the background-corrected area under the concentration-time curve, which is above the corrected baseline from the start of product use to 4 hours [cAUC(0-4h)], of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen.|From Day -1 (baseline) to Day 4|Values below the Lower Limit of Quantification were set to missing.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2530683|NCT03380429|Secondary|Percentage of Participants With an Increase From Baseline >=3 in ACT Total Score at Month 6|The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline value was the latest assessment prior to randomization (Day 1, pre-dose). Percentage of participants with an increase from Baseline >=3 in ACT total score at Month 6 is presented.|Baseline and Month 6|ITT Population|||Percentage of participants|||Number
2530684|NCT03380429|Secondary|Percentage of Participants Attaining Asthma Control (Percentage of Participants With an ACT Total Score >=20) at Month 6|Percentage of participants attaining asthma control was defined as participants with an ACT total score >=20 at Month 6. The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Percentage of participants who attained asthma control at Month 6 is presented.|Month 6|ITT Population|||Percentage of participants|||Number
2530685|NCT03380429|Secondary|Change From Baseline in Asthma Control Test (ACT) Total Score|The ACT is a validated self-completed questionnaire utilizing 5 questions to assess asthma control on a 5-point categorical scale ranging from 1 (not controlled at all) to 5 (completely controlled). Total score is calculated as the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline value was the latest assessment prior to randomization (Day 1, pre-dose). Change from Baseline was calculated as post-dose visit value minus the Baseline value.|Baseline and Month 6|ITT Population. Only those participants with data available at the specified data points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2530686|NCT03380429|Secondary|Number of Doses of Rescue Medication Use Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor|Data for rescue medication use was collected by the clip-on sensor for salbutamol MDI which records time and date when the MDI was actuated. Total rescue use was determined by the rescue sensor records of date, time and number of inhaler actuations. The mean number of doses of rescue medicines between Months 4 and 6 when maintenance data was supplied to both the participant and the HCP (Cohort 1); maintenance data was only supplied to participants (Cohort 2); rescue and maintenance data were supplied to participant and HCP (Cohort 3) and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.|Month 4 to Month 6|ITT Population. Only those participants with data available at the specified data points were analyzed.|||Doses of rescue medication||Standard Deviation|Mean
2530687|NCT03380429|Secondary|Percentage of Rescue Free Days Between Month 4 and Month 6 as Determined by the Rescue Medication Sensor|Data for rescue medication use was collected by the clip-on sensor for salbutamol MDI which records time and date when the MDI was actuated. Percentage of rescue free days were determined by the rescue sensor records of date, time and number of inhaler actuations. Least Square mean percentage of rescue free days between Months 4 and 6 when maintenance data was supplied to both the participant and the HCP (Cohort 1); maintenance data was only supplied to participants (Cohort 2); rescue and maintenance data were supplied to participant and HCP (Cohort 3) and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.|Month 4 to Month 6|ITT Population. Only those participants with rescue data observed/imputed at the specified time points were analyzed.|||Percentage of rescue free days||Standard Error|Least Squares Mean
2530688|NCT03380429|Secondary|Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 6 as Determined by the Maintenance Sensor|Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 a.m. each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 1 and 6 was determined by the maintenance sensor daily adherence. The effect on daily adherence to maintenance therapy when maintenance data was supplied to both the participant and the HCP (Cohort 1), maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.|Month 1 to Month 6|ITT Population. Only those participants with adherence data observed/imputed at the specified time points were analyzed.|||Percentage of ELLIPTA doses||Standard Error|Least Squares Mean
2530689|NCT03380429|Secondary|Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 1 and Month 3 as Determined by the Maintenance Sensor|Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 a.m. each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 1 and 3 was determined by the maintenance sensor daily adherence. The effect on daily adherence to maintenance therapy when maintenance data was supplied to both the participant and the HCP (Cohort 1), maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.|Month 1 to Month 3|ITT Population. Only those participants with adherence data observed/imputed at the specified time points were analyzed.|||Percentage of ELLIPTA doses||Standard Error|Least Squares Mean
2530701|NCT03379740|Secondary|Time to the Maximum Concentration [Tmax]|To measure the time to the maximum concentration [tmax] of the P4M3 variants and subjects' own e-cigarette from the fixed puffing regimen.|From Day -1 (baseline) to Day 4||||minutes||Full Range|Mean
2530690|NCT03380429|Secondary|Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor|Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 a.m. each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 4 and 6 was determined by the maintenance sensor daily adherence over the last three months of the study period (between months 4 to 6). The effect on daily adherence to maintenance therapy when maintenance data was only supplied to participants (Cohort 2), rescue and maintenance data were supplied to participant and HCP (Cohort 3), and rescue and maintenance data only supplied to participant (Cohort 4) versus no data supplied to the participant or HCP (Cohort 5) is summarized.|Month 4 to Month 6|ITT Population. Only those participants with adherence data observed/imputed at the specified time points were analyzed.|||Percentage of ELLIPTA doses||Standard Error|Least Squares Mean
2530691|NCT03380429|Primary|"Percentage of ELLIPTA Doses Taken (Daily Adherence) Between Month 4 and Month 6 as Determined by the Maintenance Sensor for Arms; (Cohort 1: Data on Maintenance Use Supplied to Participant and HCP andCohort 5: no Data Supplied to Participant or HCP)"|Daily adherence is defined as the participant taking one dose of Relvar/Breo ELLIPTA, within a 24-hour period, starting at 12.00 anti-meridiem (a.m.) each day of the treatment period. The percentage of ELLIPTA doses taken were determined by the clip-on sensor attached to ELLIPTA, which records the time and date when the ELLIPTA cover was opened and closed. Analysis was carried out by Analysis of Covariance (ANCOVA) model. Least Square mean percentage of ELLIPTA doses taken (daily adherence) between Months 4 and 6 was determined by the maintenance sensor daily adherence over the last three months of the study period (between months 4 to 6). The daily adherence to ELLIPTA maintenance therapy when both the participant and the HCP were supplied with data from the maintenance sensor (Cohort 1) versus no data supplied to the participant or HCP (Cohort 5) is summarized.|Month 4 to Month 6|Intent-to-Treat (ITT) Population comprised of all randomized participants, excluding those who were randomized in error. Only those participants with adherence data observed/imputed at the specified time points were analyzed.|||Percentage of ELLIPTA doses||Standard Error|Least Squares Mean
2530692|NCT03380390|Primary|Percentage of Participants With at Least a 1-Grade Worsening From Baseline in the Clinician's Telangiectasia Assessment (CTA) at Any Time-point|The investigator will assess the overall severity of telangiectasia (spider veins) on the participant's facing using a 5-point scale where 0=Clear skin with no signs of telangiectasia to 4=Severe, with the presence of many visible telangiectasia. The percentage of participants with at least a 1-point worsening (increase) in the score compared to Baseline at any time-point will be reported.|Baseline (Day 1) to Day 56||||Participants|||Count of Participants
2530693|NCT03380390|Primary|Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point|The investigator will assess erythema in the treatment area using a 5-point scale. (Grade 0= Clear Skin with no signs of erythema, Grade 1=Almost clear of erythema, slight redness, Grade 2=Mild erythema, definite redness, Grade 3= Moderate erythema, marked redness, Grade 4=Severe erythema, fiery redness). The percentage of participants with at least a 1-point improvement (decrease) in the score compared to Baseline at any time-point will be reported.|Baseline (Day 1) to Day 56||||Participants|||Count of Participants
2530694|NCT03380390|Primary|Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is defined as any untoward medical occurrence in a clinical study participant administered a medicinal product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not it is related to the medicinal (investigational) product. An SAE is any untoward medical occurrence or effect that, at any dose: Results in death, Is life-threatening, Requires or prolongs inpatient hospitalization, Results in persistent or significant disability/incapacity or Results in a congenital anomaly/birth defect.|Baseline (Day 1) to Day 56|Safety Population|||Participants|||Count of Participants
2530695|NCT03379740|Secondary|Human Puffing Topography (HPT) of the P4M3 Variants and the Subjects' Own E-cigarette|Total Puff Volume measured for the P4M3 variants and the subjects' own e-cigarette from the fixed puffing regimen and the 60 minutes ad libitum use.|From Day -1 (baseline) to Day 4|HPT raw data were reviewed for recording errors by personnel independent from the study and accepted or rejected prior to analysis. HPT data with the ‘Rejected’ status were excluded from the analysis. Consequently, the number of subjects analyzed differ from the overall number of subjects analyzed.|||mL (Total Puff Volume)||90% Confidence Interval|Geometric Mean
2530696|NCT03379740|Secondary|Sensory Parameters (ad Libitum Use)|Measured with a Sensory Questionnaire (SQ) within 60 minutes after each ad libitum use period. Response to each question is assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).|From Day 1 to Day 4||||score on a scale||Standard Deviation|Mean
2530697|NCT03379740|Secondary|Sensory Parameters (Fixed Puffing Regimen)|Measured with a Sensory Questionnaire (SQ) within 60 minutes after each fixed puffing regimen use period. Response to each question is assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).|From Day 1 to Day 4||||score on a scale||Standard Deviation|Mean
2530698|NCT03379740|Secondary|Area Under the Curve of Craving for an Electronic Cigarette|"Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving), before and after the fixed puffing regimen and ad libitum use period. (The VAS craving was measured from 0 to 100 on a 100 mm scale.)~The data below present the Area under the VAS craving score-time curve from the start of product use to 4 hours.~The area under the curve for VAS craving is an integrated measurement of the VAS craving taking into account several timepoints. AUC was calculated using a trapezoidal rule between timepoints without normalization."|From Day -1 (baseline) to Day 4||||score*hr||Standard Deviation|Mean
2530699|NCT03379740|Secondary|Subjective Effects of P4M3 Use|Measured with an adapted version of the modified Cigarette Evaluation Questionnaire (adapted mCEQ) within 60 minutes after the ad libitum use session. Assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).|From Day -1 (baseline) to Day 4||||score on a scale||Standard Deviation|Mean
2530705|NCT03379740|Primary|Background-corrected Trough Plasma Nicotine Concentration [cCtrough]|To measure background-corrected trough plasma nicotine concentration [cCtrough] from 60 minutes of ad libitum use.|From Day -1 (baseline) to Day 4||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2530709|NCT03379545|Primary|Glenoid Inclination|The 3D MRI glenoid inclination is measured by the two observers with the same method used for CT 3D glenoid inclination measurement following generating a new 2D axial MR images form the 3D MRI model using the three-point method. A line on the supraspinatus fossa and 3 points are drawn: Point S represents the inferior border of the glenoid, point R represents the intersection of the supraspinatus fossa line with the glenoid surface, and point A represents the vertex of the right triangle created by the line of the supraspinatus fossa and a perpendicular line passing through point S; this line (RS) is the hypotenuse of the right triangle. The inclination corresponds to the area in which the glenoid component of RSA is implanted.|3 Months||||degrees||Standard Deviation|Mean
2530710|NCT03379545|Primary|Glenoid Version|All scans from 3D CT and 3D MR imaging were reviewed carefully for the presence of any morphological changes. For the determination of glenoid version, a line was drawn between the anterior and posterior margins of the glenoid. The transverse axis of the scapula was determined by a line drawn from the midpoint of the genoid fossa to the medial end of the image of the scapula; a line drawn perpendicular to this was defined as a line of neutral version. The angle between the line of neutral version and the line connecting the anterior and posterior margins of the glenoid was measured and recorded as the Glenoid Version.|3 Months||||degrees||Standard Deviation|Mean
2530711|NCT03379376|Secondary|Percentage of Participants Completing 4-week Visits|To be assessed by calculating the percent of participants who complete the 4-week visit.|Up to 4 weeks||||Participants|||Count of Participants
2530712|NCT03379376|Secondary|Number of Participants Reporting Adverse Events|Adverse events will be reported upon occurrence monthly. Specifically, they will be labeled definitely unrelated, definitely related, probably related, or possibly related to the study intervention.|Up to 4 weeks||||Participants|||Count of Participants
2530713|NCT03379376|Secondary|Number of Participants That Adhered to Study Interventions|To be determined by comparing participants who were adherent to attending study visits and interventions by an adherence assessment (1) Completion of the videoconference session; (2) any additional contact with the interventionists; (3) use of the self-directed intervention:|Up to 4 weeks||||Participants|||Count of Participants
2530714|NCT03379376|Secondary|Number of Participants Recruited and Completed All Assessments|Participants who were recruited and agreed to participate in the Mindful Movement and Breathing (eMMB) sessions and those who completed all assessments will be computed.|Up to 4 weeks||||Participants|||Count of Participants
2530715|NCT03379376|Primary|Number of Participants Confident in the Use of EHealth Format|This is a feasibility study to iteratively refine the eMMB implementation strategies with 10-15 consecutive participants enrolled. Participants will be asked to complete a brief usability questionnaire about their confidence in their ability to complete the intervention. The number of participants will depend on when a consensus is reached on a manual for implementing interventions and will be determined by calculating 95% confidence intervals around all the secondary outcomes.|Up to 4 weeks||||Participants|||Count of Participants
2530716|NCT03379233|Secondary|Change From Participant's 6 Weeks Baseline Total Adherence to the Participant's Total Adherence Over the Last Four Weeks of Intervention|Total adherence was defined as percentage of days on which the participant inhaled at least one dose and represented the sum of on-time adherence and off-time adherence. Off-time adherence was defined as percentage of days on which the participant did not inhale the daily dose within the (+ or -) 2 hours of the predefined PIT, but outside. The number of doses not inhaled on-time was recorded by the Concept2 inhaler.|Baseline, Week 21 - 24|Due to the early discontinuation of the study, only very few participants were randomized (7) and no participant completed the last 4 weeks of intervention, required for the evaluation of the secondary efficacy outcome measure. Therefore data for this outcome measure was not collected and reported.||||||
2530717|NCT03379233|Secondary|Change From Participant's 6 Weeks Baseline On-time Adherence to the Participant's On-time Adherence Over the Last Four Weeks of Intervention|On-time treatment adherence was defined as percentage of days on which the participant inhaled at least one dose on-time. Dose inhaled on-time was a dose inhaled within (+ or -) 2 hours of the agreed predefined preferred daily inhalation time (PIT). PIT was defined by the participant at study start.|Baseline, Week 21 - 24|Due to the early discontinuation of the study, only very few participants were randomized (7) and no participant completed the last 4 weeks of intervention, required for the evaluation of the secondary efficacy outcome measure. Therefore data for this outcome measure was not collected and reported.||||||
2530718|NCT03379233|Primary|Change in Participant's Total Adherence Over 24 Weeks of Intervention Compared to Baseline|Total adherence was defined as percentage of days on which the participant inhaled at least one dose and represented the sum of on-time adherence and off-time adherence. Off-time adherence was defined as percentage of days on which the participant did not inhale the daily dose within the (+ or -) 2 hours of the predefined PIT, but outside. The number of doses not inhaled on-time was recorded by the Concept2 inhaler.|Baseline 6 weeks, intervention 24 weeks|Due to technical issues, the actual time and day of inhaler use from the point of resetting could not be evaluated. Therefore data for this outcome measure were not collected and reported.||||||
2530719|NCT03379233|Primary|Change in Participant's On-time Adherence Over 24 Weeks of Intervention Compared to Baseline|On-time treatment adherence was defined as percentage of days on which the participant inhaled at least one dose on-time. Dose inhaled on-time was a dose inhaled within (+ or -) 2 hours of the agreed predefined preferred daily inhalation time (PIT). PIT was defined by the participant at study start.|Baseline 6 weeks, intervention 24 weeks|Due to technical issues, the actual time and day of inhaler use from the point of resetting could not be evaluated. Therefore data for this outcome measure were not collected and reported.||||||
2530720|NCT03378973|Primary|Percent of Patients With Monitorable of Motor Evoked Potentials|Monitorable is defined as stable signals being present in 3 muscles in each lower extremity, with mean peak-to-peak amplitude of at least 50 uV, and with mean-normalized interquartile variability of 0.9 or less.|During a single surgery for the duration of the operation||||Participants|||Count of Participants
2530757|NCT03374488|Secondary|Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Experiencing Adverse Events (AEs)|AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.|Up to 8 months|All Participants as Treated (APaT) population consisted of all randomized participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2530721|NCT03378076|Primary|Incidence of Treatment Emergent Adverse Events|"Safety analyses were conducted using the safety population.~Analyses of adverse events will be performed for those events that are considered treatment emergent, where treatment emergent is defined as any adverse event with onset after the administration of study medication in the first knee through the end of the study or any event that was present at baseline but worsened in intensity through the end of the study. Severity of Adverse events were graded by the Principal Investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The grading went from Grade 1 (Mild) to Grade 5 (Death related to AE)."|43 days|All patients who received study drug (injection in at least one knee).|||participants|||Number
2530722|NCT03378076|Primary|Measure the Concentration of Triamcinolone Acetonide (TA) in Blood Plasma|"Plasma drug concentrations (pg/mL) by Time Point across FX006 and TAcs treatment arms in plasma.~For the PK analysis and individual concentration vs. time plots, a concentration that is BLOQ is assigned a value of zero if it occurs in a profile before the first measurable concentration. If a BLOQ value occurs after a measurable concentration in a profile and is followed by a value above the lower limit of quantification, then the BLOQ is treated as missing data. If a BLOQ value occurs at the end of the collection interval (after the last quantifiable concentration) it is set to zero. If two BLOQ values occur in succession after Cmax, the profile is deemed to have terminated at the first BLOQ value and any subsequent concentrations are set to zero for PK calculations"|43 days|All patients who received 2 IA injections (one in each knee) of study drug, completed scheduled sampling, and had sufficient plasma concentration data|||pg/mL||95% Confidence Interval|Geometric Mean
2530723|NCT03376516|Secondary|Virus Safety Measured by the Number With Parvovirus B19 Seroconversions Between Baseline (BL) and End of Study|Virus safety was evaluated by taking a plasma sample for parvovirus B19 antibody testing before the first injection of Wilate at the PK visit. All patients negative at screening were tested again at the Study Completion visit. The number of Parvovirus B19 seroconversions between BL and end of study was recorded|6 months|Analysis was performed in all patients who underwent full analysis (FAS population) (n=10).|||Participants with seroconversions|||Number
2530724|NCT03376516|Secondary|Immunogenicity of Wilate: Number of Participants With FVIII Inhibitor Activity at 6 Months|FVIII inhibitor activity was determined at each study visit: screening, PK, Day 14 visit, Day 30 visit, 3 Months visit and 6 Months visit before injection.|6 months|The analysis was performed in the overall safety (SAF) population included all patients who received at least one injection of Wilate during the study (n=10). Of these, 5 patients 1–<6 years were analyzed, and 5 patients aged 6–<12 years were analyzed.|||Participants|||Count of Participants
2530725|NCT03376516|Secondary|Safety and Tolerability of Wilate by Monitoring The Number of Adverse Events (AEs) Throughout the Study|At each visit (whether scheduled or unscheduled) , AEs will be documented by the investigator throughout the study. In addition, the investigator will check the patient diaries for any documented event.|6 months|The safety (SAF) population included all patients who received at least one injection of Wilate during the study (n=10).|||Adverse events|||Number
2530726|NCT03376516|Secondary|Association Between VWF:Ag Concentration and the FVIII:C Half-life of Wilate|Analysis of variance (ANOVA) was used in an exploratory sense to assess a possible association between VWF:Ag with the FVIII:C half-life of Wilate. This was analysed by calculating the mean square in a one-stage (OS) assay.|6 months|The analysis was performed for the PK population which included all patients who underwent PK assessment during the study (total: n=10).|||Correlation coefficient|||Number
2530727|NCT03376516|Secondary|Association Between ABO Blood Type and the FVIII:C Half-life of Wilate (OS Assay)|Analysis of variance (ANOVA) was used in an exploratory sense to assess a possible association between the ABO blood type and the FVIII:C half-life of Wilate. This was analysed by calculating the mean square in a one-stage (OS) assay.|6 months|The analysis was performed for the PK population which included all patients who underwent PK assessment during the study (total: n=10). The PK population comprised 5 patients aged 1–<6 years and 5 aged 6–<12 years.|||Correlation coefficient|||Number
2530728|NCT03376516|Secondary|Incremental in Vivo Recovery (IVR) of Wilate Over Time|The rise in FVIII:C activity in IU/dl per unit dose administered in IU/kg was determined for all patients at baseline, 3 and 6 months, using the one-stage (OS) assay.|Baseline, and 3 and 6 months of treatment|The analysis was performed in the full analysis (FAS) population (total: n=10). The FAS comprised 5 patients were aged 1–<6 years and 5 were aged 6–<12 years.|||kg/dL||Standard Deviation|Mean
2530729|NCT03376516|Secondary|Wilate Consumption Data: Average Dose of Wilate Per Week of Study|The average consumption of Wilate per week of the study (IU/kg) for all patients receiving prophylaxis|6 months|The analysis was performed in the full analysis (FAS) population (total: n=10). The FAS comprised 5 patients were aged 1–<6 years and 5 were aged 6–<12 years.|||IU/kg per week||Standard Deviation|Mean
2530730|NCT03376516|Secondary|Efficacy of Wilate in the Treatment of Breakthrough Bleeding Events (BEs)|"The proportion of BEs successfully treated with Wilate was assessed by the patient (together with the investigator in case of on-site treatment) in a patient diary. The treatment efficacy for all BEs was assessed using a pre-defined four-point scale: 'excellent', 'good', 'moderate', 'none'. 'Excellent' was defined as Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single injection (best outcome); 'good 'was defined as definite pain relief and/or improvement in signs of bleeding within approximately 8-12 hours after an injection, requiring up to 2 injections for complete resolution. All efficacy ratings assessed as either 'excellent' or 'good' were considered 'successfully treated'. 'Moderate' was defined as probable or slight beneficial effect within approximately 12 hours after the first injection and 'none' defined as no improvement within 12 hours, or worsening of symptoms."|6 months|Analysis was performed in the per-protocol (PP) population. Of the patients in the PP population, only 8 patients had evaluable bleeding events. Five of these patients were aged 1–<6 years, and 3 aged 6–<12 years.|||Bleeding Events (BEs)|Bleeding Events (BEs)||Count of Units
2530758|NCT03374488|Primary|Objective Response Rate (ORR) With Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo|ORR was defined as the percentage of participants who had a complete response (CR), disappearance of all target lesions or partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions per RECIST v1.1 by investigator determination.|up to 9 weeks +14 days|"The Intention-to-Treat (ITT) population consisted of all randomized participants.~Responses are based on Investigator assessments per RECIST 1.1 without confirmation using all scans up to week 9 (day 63) + 14 days."|||percentage of participants||95% Confidence Interval|Number
2530731|NCT03376516|Secondary|Spontaneous Annualized Bleeding Rate (SABR)|"The SABR was calculated in analogy to the TABR. The total number of spontaneous bleeding events (BEs) in the time period between the first dose of IMP and the study completion visit, divided by the duration (in years) between the first dose of IMP and the study completion visit.~Surgery periods, and BEs occurring within these periods, will be excluded from the calculation of the SABR."|6 months|This analysis was performed for the full-analysis (FAS) population which included all patients who has at least one injection of Wilate (n=10). The FAS population comprised 5 patients aged 1–<6 years and 5 patients aged 6–<12 years.|||Spontaneous bleeding events per year||Standard Deviation|Mean
2530732|NCT03376516|Secondary|Total Annualized Bleeding Rate (TABR)|"The total number of bleeding events (BEs) in the time period between the first dose of IMP and the study completion visit, divided by the duration (in years) between the first dose of IMP and the study completion visit.~Surgery periods, and BEs occurring within these periods, will be excluded from the calculation of TABR."|6 months|This analysis was performed for the full-analysis (FAS) population which included all patients who has at least one injection of Wilate (n=10). The FAS population comprised 5 patients aged 1–<6 years and 5 patients aged 6–<12 years.|||Bleeding events per year (TABR)||Standard Deviation|Mean
2530733|NCT03376516|Primary|Incremental In Vivo Recovery (IVR) of FVIII:C|"The incremental IVR was determined from all patients at baseline was determined using the one-stage (OS) assay (standardised to 50 IU/kg).~The units of measure to calculate IVR is kilograms (kg) / deciliter (dL)"|48 h following a single dose of Wilate|This analysis was performed for the full-analysis (FAS) population which included all patients who has at least one injection of Wilate (n=10). The FAS population comprised 5 patients aged 1–<6 years and 5 patients aged 6–<12 years.|||kg/dL||Standard Deviation|Mean
2530734|NCT03376516|Primary|Pharmacokinetic (PK) Assessment (Clearance) of FVIII:C|PK assessments of the factor VIII coagulant activity (FVIII:C) for Wilate were determined using the one-stage (OS) assay. The units of measure to calculate clearance are decilitre (dL)/ hours (h)/ kilograms (kg).|0h, 0.25h, 1h, 6h, 24h and 48 h following a single dose of Wilate|The analysis was performed in the PK population which included all patients who underwent PK assessment during the study (total: n=10). The PK population comprised 5 patients aged 1–<6 years and 5 patients aged 6–<12 years.|||dL/h/kg||Standard Deviation|Mean
2530735|NCT03376516|Primary|Pharmacokinetic (PK) Assessment (Volume of Distribution (Vd)) of FVIII:C|PK assessments of the factor VIII coagulant activity (FVIII:C) for Wilate were determined using the one-stage (OS) assay. The units of measure to calculate Vd is decilitre (dL)/ kilograms (kg).|0h, 0.25h, 1h, 6h, 24h and 48 h following a single dose of Wilate|The analysis was performed in the PK population which included all patients who underwent PK assessment during the study (total: n=10). The PK population comprised 5 patients aged 1–<6 years and 5 patients aged 6–<12 years.|||dL/kg||Standard Deviation|Mean
2530736|NCT03376516|Primary|Pharmacokinetic (PK) Assessment (Mean Residence Time (MRT)) of FVIII:C|PK assessments of the factor VIII coagulant activity (FVIII:C) for Wilate were determined using the one-stage (OS) assay. The units of measure to calculate MRT is hours.|48 h following a single dose of Wilate|The analysis was performed in the PK population which included all patients who underwent PK assessment during the study (total: n=10). The PK population comprised 5 patients aged 1–<6 years and 5 patients aged 6–<12 years.|||hours||Standard Deviation|Mean
2530737|NCT03376516|Primary|Pharmacokinetic (PK) Assessment (Time to Reach Maximum Plasma Concentration (Tmax)) of FVIII:C|PK assessments of the factor VIII coagulant activity (FVIII:C) for Wilate were determined using the one-stage (OS) assay. The units of measure to calculate Tmax is hours (h).|48 h following a single dose of Wilate|The analysis was performed in the PK population which included all patients who underwent PK assessment during the study (total: n=10). The PK population comprised 5 patients aged 1–<6 years and 5 patients aged 6–<12 years.|||hours||Standard Deviation|Mean
2530738|NCT03376516|Primary|Pharmacokinetic (PK) Assessment (Maximum Plasma Concentration) for FVIII:C|"PK assessments of FVIII:C were determined using the one-stage (OS) assays. The maximum plasma concentration of FVIII:C was calculated based on the FVIII:C values measured in the patients participating in the PK study.~Units of measure for maximum plasma concentration are international units (IU)/ decilitre (dL)"|0h, 0.25h, 1h, 6h, 24h and 48 h following a single dose of Wilate|The analysis was performed in the PK population which included all patients who underwent PK assessment during the study (total: n=10). The PK population comprised 5 patients aged 1–<6 years and 5 patients aged 6–<12 years.|||IU/dL||Standard Deviation|Mean
2530739|NCT03376516|Primary|Pharmacokinetic (PK) Assessment (Half-life (h)) of FVIII:C|PK assessments of the factor VIII coagulant activity (FVIII:C) for Wilate were determined using the one-stage (OS) assay. The units of measure to calculate half-life is hours.|0h, 0.25h, 1h, 6h, 24h and 48 h following a single dose of Wilate|The analysis was performed in the PK population which included all patients who underwent PK assessment during the study (total: n=10). The PK population comprised 5 patients aged 1–<6 years and 5 patients aged 6–<12 years.|||hours||Standard Deviation|Mean
2530740|NCT03376516|Primary|Pharmacokinetic (PK) Assessment (Area Under the Curve [AUC] Normalised (AUCNorm)) of FVIII:C for Wilate|"PK assessments of the factor VIII coagulant activity (FVIII:C) for Wilate were determined using the one-stage (OS) assay. The mean area under the curve normalised for the administered dose (AUCnorm) was calculated for Wilate.~The units of measure used were AUC divided by dose."|0h, 0.25h, 1h, 6h, 24h and 48 h following a single dose of Wilate|The analysis was performed in the PK population which included all patients who underwent PK assessment during the study (total: n=10). The PK population comprised 5 patients aged 1–<6 years and 5 patients aged 6–<12 years.|||h*kg/dL||Standard Deviation|Mean
2530741|NCT03376516|Primary|Pharmacokinetic (PK) Assessment (Area Under the Curve (AUC)) of FVIII:C|PK assessments of the factor VIII coagulant activity (FVIII:C) for Wilate were determined using the one-stage (OS) assay. The units of measure to calculate AUC is hours (h) x international units (IU)/decilitre (dL).|0h, 0.25h, 1h, 6h, 24h and 48 h following a single dose of Wilate|The analysis was performed in the PK population which included all patients who underwent PK assessment during the study (total: n=10). The PK population comprised 5 patients aged 1–<6 years and 5 patients aged 6–<12 years.|||h*IU/dL||Standard Deviation|Mean
2530759|NCT03374189|Secondary|Number of Participants With Wound Dehiscence|Wound dehiscence that required further treatment|3 days post-op and within one months of surgery||||Participants|||Count of Participants
2530760|NCT03374189|Secondary|Number of Participants With Ascitic Fluid Leakage|Non-infective fluid leakage|3 days post-op and within one months of surgery||||Participants|||Count of Participants
2530742|NCT03376295|Secondary|The Occurrence of the First Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)|The number of the first occurences of the hospitalization for community-acquired pneumonia (serious pneumonia)associated with LABA-TIO relative to LABA-ICS in patients with COPD, with one-year follow-up, from the as-treated analysis and from the time-dependent on-treatment analysis based on current exposure is presented. On-treatment exposure was based on analysis of current use during the entire 1-year follow-up, allowing patients to switch treatments.|12 years|The main analysis was on matched patients. The patients with LABA-TIO initiators were matched with initiators of LABA-ICS using a time-conditional propensity score-matched approach.|||Hospitalizations|||Number
2530743|NCT03376295|Secondary|The Rate of COPD Exacerbations|Incidence rates and rate ratios of the moderate or severe exacerbation associated with LABA-TIO relative to LABA-ICS in patients with COPD, with one-year follow-up, from the as-treated analysis, estimated.|12 years|The main analysis was on matched patients. The patients with LABA-TIO initiators were matched with initiators of LABA-ICS using a time-conditional propensity score-matched approach.|||Events per participant-year|||Number
2530744|NCT03376295|Primary|The Number of Observed Patients With First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation to Occur After Cohort Entry|The number of observed patients with first COPD exacerbation after cohort entry was reported. The event of time to first COPD exacerbation to occur after cohort entry was defined as a hospitalization for COPD (severe exacerbation) or the prescription of an oral corticosteroid, namely prednisolone (moderate exacerbation) to occur after cohort entry with one-year follow-up, from the as-treated analysis.|12 Years|The main analysis was on matched patients. The patients with LABA-TIO initiators were matched with initiators of LABA-ICS using a time-conditional propensity score-matched approach.|||Participants|||Count of Participants
2530745|NCT03376061|Secondary|Mean Concentration of TxA in Plasma Collected From Participants|Plasma TxA concentrations measured from blood samples taken upon arrival in the ICU|on arrival in ICU within 3 hours|4 patients from the topical TxA group and 3 patients from the intravenous TxA group were excluded because they either did not receive a TxA dose or received an incomplete TxA dose.|||microgram per milliliter per kilogram||Standard Deviation|Mean
2530746|NCT03376061|Secondary|Median Number of Hours Participants Spent in ICU|Number of hours participants spent in the intensive care unit (ICU)|Number of hours spent in ICU from arrival to exit (collected at the Post-Operative Visit).||||hours||Inter-Quartile Range|Median
2530747|NCT03376061|Secondary|Number of Participants With Re-operation for Bleeding or Tamponade|Occurrence of re-operation for the purpose of bleeding or cardiac tamponade|Patients will be followed post-operatively until hospital discharge||||Participants|||Count of Participants
2530748|NCT03376061|Secondary|Number of Participants With RBC Transfusion|Patients requiring a red blood cell transfusion|Intra-operative and post-operative RBC transfusions||||Participants|||Count of Participants
2530749|NCT03376061|Secondary|Number of Participants With Mortality|The occurrence of death due to any cause|Patients will be followed post-operatively until hospital discharge||||Participants|||Count of Participants
2530750|NCT03376061|Secondary|Number of Participants With Seizures|Patients experiencing a post-operative seizure|Patients will be followed post-operatively until hospital discharge||||Participants|||Count of Participants
2530751|NCT03376061|Primary|Median Volume of Mediastinal Fluid Collected From Participants|Cumulative volume (mL) of fluid collected from mediastinal drainage tubes 24 hours after the surgical procedure|Fluid collected in the first 24 hours after the surgical procedure||||mL||Inter-Quartile Range|Median
2530752|NCT03374995|Primary|Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale|Change in skin appearance by the participants' self-report using the Dermatology Quality of Life Index (DLQI) was used to assess skin after completion of radiation. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. A higher score shows better performance/improvement in skin appearance. The average Dermatology Qualify of Life Index score each study visit will be compared between the two arms with the number of participants reporting a score.|Baseline to up to 7 weeks||||Participants|||Count of Participants
2530753|NCT03374995|Primary|Physician Observed Improvement in Skin Appearance|Skin appearance was assessed by the treating physician at each visit (total of 7) using the Radiation Therapy Oncology Group (RTOG) Toxicity scale Grade 1 and Grade 2 assessed only. Score = (Grade 1 (follicular, faint or dull erythema, dry desquamation and Grade 2 (tender or bright erythema, patchy, ,moist desquamation) with Grade 2 being the worst for this study. Scores range from 0 to 2, with higher values being the worst. The average RTOG score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure.|Baseline to up to 7 weeks||||units on a scale||Standard Deviation|Mean
2530754|NCT03374995|Primary|Change in Quality of Life|A 10-item assessment completed at each visit (7 total) to measure participant's Dermatology Life Quality Index. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. The higher the score the more qualify of life is impaired. The average DQLI score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure.|Baseline to up to 7 weeks||||score on a scale||Standard Deviation|Mean
2530755|NCT03374995|Primary|Incidence of Early Adverse Skin Reactions (EASRs)|The Modified ONS Criteria for Radiation-Induced Acute Skin Toxicity will be used for classification of EASRs related to the skin. Participants will report in a total of 7 visits any experience with Grade I (faint or dull erythema; dry desquamation or Grade II (tender or bright erythema, patchy, moist desquamation) acute radiation dermatitis using the RTOG (Radiation Therapy Oncology Group) grading system with Grade II considered the worse outcome. Comparative effectiveness will include the number or study participants in each arm that experience RTOG Grade I or Grade II radiation dermatitis and moist desquamation.|Up to 4 weeks post-RT||||Participants|||Count of Participants
2530756|NCT03374488|Secondary|Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Discontinuing Study Treatment Due to AE|AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.|Up to 8 months|All Participants as Treated (APaT) population consisted of all randomized participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2530765|NCT03374189|Primary|Time Taken to Complete Closure|The start of the procedure was defined as the point when the device was first inserted through the port-site and the end of the procedure was defined as the point when the port-site was removed from the port-site. A stopwatch was used to measure the time.|At the time of surgery||||seconds||Standard Deviation|Mean
2530766|NCT03373890|Secondary|Change in Muscle Architecture-hypertrophy High Versus Low Frequency SBLTT Groups|Rectus femoris mid thigh fascicle length as measured by 2D B Mode Ultrasound High Versus Low Frequency SBLTT Groups|Change from baseline to immediately post SBLTT|Change in rectus femoris mid thigh fascicle length as measured by 2D B Mode ultrasound , from baseline to immediately post SBLTT compared between high and low frequency groups/arms.|||millimeters||Standard Deviation|Mean
2530767|NCT03373890|Secondary|Change in Muscle Architecture-High Versus Low Frequency SBLTT Groups|Rectus femoris mid thigh cross-sectional area as measured by 2D B Mode Ultrasound High Versus Low Frequency SBLTT Groups|Change from baseline to immediately post SBLTT|Change in rectus femoris cross sectional area as measured by 2D B Mode ultrasound, from baseline to immediately post SBLTT compared between high and low frequency groups/arms.|||mm^2||Standard Deviation|Mean
2530768|NCT03373890|Secondary|Change in Muscle Performance - Strength High Versus Low Frequency SBLTT Groups|Knee extensor muscle strength - isometric muscle strength as measured by Biodex testing High Versus Low Frequency SBLTT Groups|Change from baseline to immediately post SBLTT|Change in normalized isometric quadriceps strength as measured by Biodex, from baseline to immediately post SBLTT compared between high and low frequency groups/arms.|||newton meters||Standard Deviation|Mean
2530769|NCT03373890|Secondary|Change in Muscle Performance -Power High Versus Low Frequency SBLTT Groups|Knee extensor muscle power - isotonic muscle power as measured by Biodex testing High Versus Low Frequency SBLTT Groups|Change from baseline to 6 weeks post SBLTT||||watts||Standard Deviation|Mean
2530770|NCT03373890|Primary|Change in Walking Endurance- High Versus Low Frequency SBLTT Groups|Distance walked during the One Minute Walk Test High Versus Low Frequency SBLTT Groups|Change from baseline to immediately post SBLTT|Change in distance walked in one minute between baseline and immediately post SBLTT compared between high and low frequency groups.|||meters||Standard Deviation|Mean
2530771|NCT03373890|Primary|Change in Walking Capacity High Versus Low Frequency SBLTT Groups|Self selected walking speed as measured by 10 meter walk test High Versus Low Frequency SBLTT Groups|Change from baseline to immediately post SBLT.|Change in self selected walking speed between baseline and immediately post SBLTT was compared between the high and low frequency groups/arms.|||meters per sec||Standard Deviation|Mean
2530772|NCT03373890|Primary|Change in Community Walking Performance Intensity High Versus Low Frequency SBLTT Groups|Average Strides/day > 30 strides/min as measured by StepWatch accelerometry High Versus Low Frequency SBLTT Groups|Change from baseline to immediately post SBLTT|Change in average strides/day > 30 strides/min as measured by StepWatch accelerometry for one side a cross 5 days (4 weekdays and 1 weekend day)|||strides per day||Standard Error|Mean
2530773|NCT03373890|Primary|Change in Walking Performance High Versus Low Frequency SBLTT Groups|Average stride per day as measured by StepWatch accelerometry. StepWatch accelerometer stride counts per day ( minimum of 8 hrs/day wearing time) were averaged a crossed 5 days (4 weekdays and 1 weekend day) to create Average Strides/day variable|Change from baseline to immediately post SBLTT|Change in average strides/day from baseline to immediately post SBLTT were compared between the high and low frequency groups/arms.|||strides per day||Standard Deviation|Mean
2530774|NCT03373591|Secondary|Time to Ambulation||Assessed every 24 hours post surgery, up to 168 hour post-surgery.||||Hours||Standard Deviation|Mean
2530775|NCT03373591|Secondary|Nausea|Number of participants with presence or absence of nausea reported and recorded by the nurse.|24 hours post surgery.||||Participants|||Count of Participants
2530776|NCT03373591|Secondary|Length of Stay|Hours of hospitalization post-surgery|Assessed every 24 hours post surgery, up to 168 hour post-surgery.||||Participants|||Count of Participants
2530777|NCT03373591|Secondary|Pain Score|Patient reported composite measure pain score, with a total range of 0 to 10, with 0 being the absence of pain, 1 being the least amount of pain and 10 being the highest amount of pain.|24 hours post surgery.||||units on a scale||Standard Deviation|Mean
2530778|NCT03373591|Secondary|NSAID Usage|Total amount of NSAID (ketorolac) use for analgesia.|During hospitalization, up to 7 days.||||Miligrams||Standard Deviation|Mean
2530779|NCT03373591|Secondary|Acetaminophen Usage|Total amount of acetaminophen used for analgesia.|During hospitalization, up t 7 days.||||Miligrams||Standard Deviation|Mean
2530780|NCT03373591|Primary|Total Fentanyl Usage|Total fentanyl usage in micrograms, including both PCA and IV push administered medication.|During hospitalization, up to 7 days.||||Micrograms||Standard Deviation|Mean
2530781|NCT03373591|Primary|Fentanyl PCA mcg|Fentanyl PCA (patient controlled analgesia) total microgram usage.|24 hours post surgery.||||Micrograms||Standard Deviation|Mean
2530782|NCT03373162|Secondary|Number of Participants With Structural Brain Volume Change Following Botox Injections|Participants were scanned 1-13 days prior to Botox injections in the glabellar region and then again 14-21 days post-injection when the Botox had reached effectiveness. Structural scans for each participant were segmented using Freesurfer's automatic software for volumetric measures and then normalized by dividing by total intracranial volume for each participant. We then conducted t-tests for pre- vs. post- BOTOX injections to investigate any structural changes.|15-33 days between pre and post-Botox scans||||Participants|||Count of Participants
2530783|NCT03373162|Primary|Change From Baseline in Functional MRI Mean Blood Oxygen Level Dependent (BOLD) Response in the Amygdala|Understand the effect of BOTOX on functional activity (measured using fMRI) in the brain. Participants were scanned 1-13 days prior to Botox injections in the glabellar region and then again 14-21 days post-injection when the Botox had reached effectiveness. Participants viewed Happy and Angry faces and rated each one as pleasant or unpleasant. We then masked activity in the amygdala to investigate the difference in BOLD response for collapsed across emotion following Botox injections.|15-33 days between pre and post-Botox scans||||fMRI BOLD in Left Amygdala||Standard Error|Mean
2530952|NCT03365934|Primary|Microbial Community Richness - (Day 7)|Swabs will be collected on the back at Day 7 and analyzed to determine the total number of different bacteria Taxa (microorganismss) detected in the sample.|Day 7||||Number of bacterial taxa||95% Confidence Interval|Mean
2530784|NCT03373162|Primary|Glutamate + Glutamine (Glx)/Creatine Ratio as Measured by MRS in the Brainstem Pre and Post-Botox|Determine whether there are metabolic differences in the brain stem in healthy individuals as a result of BOTOX using MRS. Participants were scanned 1-13 days prior to Botox injections in the glabellar region and then again 14-21 days post-injection when the Botox had reached effectiveness. Metabolite FIDs were averaged within each task and processed using TARQUIN (v.4.3.6) software for spectral fitting. The acquired MRS spectra was corrected for tissue type and T2 relaxation differences. Using TARQUIN we obtained values for Glutamate + Glutamine (Glx), normalized by Creatine.|15-33 days between pre and post-Botox scans||||Brainstem GLX/Cr||Standard Error|Mean
2530785|NCT03372603|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Twelve-lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Number of participants with abnormal-clinically significant and abnormal-not clinically significant values has been presented.|Baseline (pre-dose on Day 1) and Day 8 of each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category title).|||Participants|||Count of Participants
2530786|NCT03372603|Secondary|Change From Baseline in Heart Rate|Heart rate was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.|Baseline (pre-dose on Day 1) and Day 8 of each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed.|||Beats per minute||Standard Deviation|Mean
2530787|NCT03372603|Secondary|Change From Baseline in Temperature|Temperature was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.|Baseline (pre-dose on Day 1) and Day 8 of each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed.|||Degrees Celsius||Standard Deviation|Mean
2530788|NCT03372603|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|Blood pressure was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.|Baseline (pre-dose on Day 1) and Day 8 of each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
2530789|NCT03372603|Secondary|Number of Participants With Abnormal Urinalysis Data|Urine samples were collected for analysis of urinalysis data by dipstick method. Number of participants with abnormal urinalysis data has been presented. Abnormality was defined as value of potential clinical importance (PCI). PCI was flagged when a result changed from negative on Day 1 (pre-dose) to positive on Day 8.|Up to Day 8|All Subjects Population. Only those participants with data available at the specified data points were analyzed.|||Participants|||Count of Participants
2530790|NCT03372603|Secondary|Change From Baseline Values for Hematology Parameter: Reticulocytes|Blood samples were collected for the analysis of hematology parameter: reticulocytes. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and Day 8 for each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed.|||Percentage of reticulocytes in blood||Standard Deviation|Mean
2530791|NCT03372603|Secondary|Change From Baseline Values for Hematology Parameter: Red Blood Cell (RBC) Count|Blood samples were collected for the analysis of hematology parameter: RBC count. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and Day 8 for each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed.|||Tera units per liter||Standard Deviation|Mean
2530792|NCT03372603|Secondary|Change From Baseline Values for Hematology Parameter: Mean Corpuscular Volume (MCV)|Blood samples were collected for the analysis of hematology parameter: MCV. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and Day 8 of each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed.|||Femtoliters||Standard Deviation|Mean
2530793|NCT03372603|Secondary|Change From Baseline Values for Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)|Blood samples were collected for the analysis of hematology parameter: MCH. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and Day 8 for each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed.|||Picograms||Standard Deviation|Mean
2530794|NCT03372603|Secondary|Change From Baseline Values for Hematology Parameter: Hematocrit|Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and Day 8 of each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed.|||Percentage of red blood cells in blood||Standard Deviation|Mean
2530795|NCT03372603|Secondary|Change From Baseline Values for Hematology Parameter: Hemoglobin|Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and Day 8 for each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed.|||Grams per liter||Standard Deviation|Mean
2530796|NCT03372603|Secondary|Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count|Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and WBC count. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and Day 8 of each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed.|||Giga units per liter||Standard Deviation|Mean
2530797|NCT03372603|Secondary|Number of Participants With Abnormal Values of Cardiac Troponin|Cardiac troponin values was measured in participants.|Up to 45 days|All Subjects Population.|||Participants|||Count of Participants
2530798|NCT03372603|Secondary|Change From Baseline Values for Clinical Chemistry Parameter: Total Protein|Blood samples were collected for the analysis of clinical chemistry parameter total protein. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and Day 8 of each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed.|||Grams per liter||Standard Deviation|Mean
2530799|NCT03372603|Secondary|Change From Baseline Values for Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Urea|Blood samples were collected for the analysis of clinical chemistry parameters including calcium, glucose, potassium, sodium and urea/blood urea nitrogen (BUN). Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and Day 8 of each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed.|||Millimoles per liter||Standard Deviation|Mean
2530800|NCT03372603|Secondary|Change From Baseline Values for Clinical Chemistry Parameter: Direct Bilirubin, Total Bilirubin and Creatinine|Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, total bilirubin and creatinine. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and Day 8 for each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed.|||Micromoles per liter||Standard Deviation|Mean
2530801|NCT03372603|Secondary|Change From Baseline Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Amino Transferase (AST) and Creatinine Kinase (CK)|Blood samples were collected for the analysis of clinical chemistry parameters including ALP, ALT, AST and CK. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and Day 8 of each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed.|||International units per liter||Standard Deviation|Mean
2530802|NCT03372603|Secondary|Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment.|Up to 45 days|All Subjects Population.|||Participants|||Count of Participants
2530803|NCT03372603|Primary|Total Cough Counts During Day Time Hours Following 7-days of Dosing|Coughs were monitored using the VitaloJAK cough monitor. The total cough counts during day-time (10 hours) was calculated from the time of the monitor being attached i.e. immediately after dosing on Day 7 to 10 hours past the time of monitoring. Total cough counts were log-transformed prior to analysis. A non-informative prior was used. Analysis was performed using a Bayesian mixed model adjusting for subject-level and period-adjusted baselines, treatment and period. Subject-level baseline is defined as the mean of the two period-specific baselines. Period-adjusted baseline is defined as the difference between the period-specific baseline and subject-level baseline for each period. Posterior median and 95% credible interval is reported. All Subjects Population included all randomized participants who took at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.|Up to 10 hours post-dose on Day 7 of each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed.|||Cough counts||95% Confidence Interval|Median
2530804|NCT03372551|Primary|Conjunctival Staining|Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=severe) in 0.25 steps|up to 1 week|Baseline n=32 participants / 64 eyes, 1 week n= 31 participants / 62 eyes due to non-serious adverse event participant's measurements weren't completed.|||score on a scale|Eyes|Standard Deviation|Mean
2530805|NCT03372551|Primary|Corneal Staining|Amount of staining observed on the cornea scored 0-4 (0=none, 4=severe) in 0.25 steps|up to 1 week|Baseline n=32 participants / 64 eyes, 1 week n = 31 participants / 62 eyes due to non-serious adverse event participant's measurements weren't completed.|||score on a scale|Eye|Standard Deviation|Mean
2530806|NCT03372551|Primary|Subjective Vision|Subjective vision scored 0-100 (0=Extremely poor, 100=Excellent vision all the time)|up to 1 week||||score on a scale||Standard Deviation|Mean
2530807|NCT03372551|Primary|Vision|Visual acuity measured in logMAR|Up to 1 week|Dispensing - n=32 participants total, 1 week = 31 participants total due to a nonserious adverse events for somofilcon A 1 day test lens.|||Log(MAR)||Standard Deviation|Mean
2530808|NCT03372551|Primary|Preference|Overall lens that subject prefers or no preference|up to 1 week||||Participants|||Count of Participants
2530809|NCT03372551|Primary|Comfort|Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever)|up to 1 week||||score on a scale||Standard Deviation|Mean
2530810|NCT03372382|Secondary|Patient Satisfaction|patient satisfaction as measured by the following scale: 1(very dissatisfied) 2(somewhat dissatisfied) 3(neutral) 4(satisfied) 5(very satisfied)|2-4 weeks postpartum||||Participants|||Count of Participants
2530811|NCT03372382|Primary|Pain Level|"pain level measured by objective and subjective scales.~1- Objective scale: visual analogue pain score (VAS). It is a 100 mm line, patients will be instructed to mark a point in the line that represents their pain level. A point towards the left will mean less pain and a point towards the right will mean more pain. After the patient makes a selection, the research team will measure where the selected point is (in cm). minimum measurement =0mm = no pain. maximum measurement=100mm=worst pain."|2-4 weeks postpartum|The primary outcome was available in 71 patients in the non-opioid group and 76 patients in the opioid group. The results below are primary outcome data analyzed by intention to treat.|||millimeters on a scale||Standard Deviation|Mean
2530812|NCT03372369|Post-Hoc|Change in Mean Accuracy of Perceived Pregnancy Risk Score|"Women are asked what their chances of getting pregnant this year are (very high, high, moderate, low, very low). This response is compared to the most effective contraceptive method women reported using in the past three months using the same categories of effectiveness as in the change in effective contraception preference score outcome. Women received a score of 1 if their perceived pregnancy risk was accurate based on their current contraceptive method and a score of 0 if it was inaccurate. Women's perceived pregnancy risk was accurate if: they used a highly effective method and they said they were at very low risk; if they used an effective method and they said they were at low or moderate risk; if they used a less effective method and said they were at moderate or high risk; or if they used no method and said they were at very high risk. A good outcome would be increased accuracy of perceived pregnancy risk as reflected by a higher score."|Baseline and 15-20 minutes after baseline (2 minutes after exposure to a poster)||||scores on a scale||99% Confidence Interval|Mean
2530813|NCT03372369|Primary|Change in Perceived Pregnancy Risk Score|Women are asked what their chances of getting pregnant this year are (very high=4, high=3, moderate=2, low=1, very low=0). A good outcome in terms of reducing the risk of unprotected sex and unplanned pregnancy would be increased perceived pregnancy risk as reflected in a higher score.|Baseline and 15-20 minutes after baseline (2 minutes after exposure to a poster)||||scores on a scale||99% Confidence Interval|Mean
2530814|NCT03372369|Primary|Change in Effective Contraception Preference Score|"Women will be asked whether they are planning on switching contraceptive methods in the next year and which methods of contraception they would hypothetically consider using if they were to switch contraceptive methods within the next year. They are then asked to rank the methods in order of how likely they would be to use each method. A woman's contraceptive preference is the method that she says she would be most likely to use. Methods will be scored from 0-3: '0' for no method, '1' for ineffective methods like condoms, '2' for effective methods like the Pill, and '3' for highly effective methods like Intrauterine Devices (IUDs). Positive scores reflect improvements in the effectiveness of the contraceptive method that women say they are likely to use."|Baseline and 15-20 minutes after baseline (1 minute after exposure to a poster)||||scores on a scale||99% Confidence Interval|Mean
2530815|NCT03372369|Primary|Change in Contraceptive Knowledge Assessment (CKA) Score|The CKA is a 25-item tool covering knowledge gaps like long-acting reversible contraceptives, emergency contraception, common myths, and efficacy rates which will be used to determine contraception knowledge. One point is added for each correctly answered question for a total possible score of 25. Higher scores reflect greater contraceptive knowledge.|Baseline and 15-20 minutes after baseline (3 minutes after exposure to a poster)||||scores on a scale||99% Confidence Interval|Mean
2530816|NCT03371459|Secondary|Baseline-adjusted FEV1 AUC0-6 After the Last Cumulative Dose|The baseline-adjusted FEV1 AUC0-6 is the area under the curve for change from baseline calculated using the trapezoidal rule and normalized by dividing the AUC by the length of follow up post the last cumulative dose (typically 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose) normalized for length of follow up).|Over 6 hours post dose on Day 1||||Liter||95% Confidence Interval|Least Squares Mean
2530817|NCT03371459|Primary|Baseline-adjusted FEV1 30 Minutes After Each Cumulative Dose|Forced expiratory volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation|At the two study treatment visits, FEV1 (forced expiratory volume in 1 second) will be measured prior to drug administration and 5 times, once at 30 minutes after each of the 5 doses||||Liter||95% Confidence Interval|Least Squares Mean
2530818|NCT03371381|Secondary|Phase 1b: Number of Participants With Anti-nivolumab Antibodies|Number of participants with antibodies to nivolumab were reported.|Up to 6.8 months|The all treated analysis population consisted of participants who received at least 1 dose of study agent.|||Participants|||Count of Participants
2530819|NCT03371381|Secondary|Phase 1b: Serum Concentrations of Nivolumab|Nivolumab serum concentrations were reported.|Up to 6.8 months|Pharmacokinetic (PK) population consisted of all participants who received at least 1 dose of study agent and had one PK blood sample available. Although PK samples were collected, but assays were not run due to no longer development of compound.||||||
2530820|NCT03371381|Secondary|Phase 1b: Number of Participants With Bacterial Shedding|Number of participants with bacterial shedding were reported. The shedding of JNJ-64041757 was studied in feces by stool or rectal swab, urine and saliva.|Up to 6.8 months|The all treated analysis population consisted of participants who received at least 1 dose of study agent.|||Participants|||Count of Participants
2530821|NCT03371381|Secondary|Phase 1b: Number of Participants With Positive Blood Culture|Number of participants with surveillance cultures positive for listeriosis were reported.|Up to 6.8 months|The all treated analysis population consisted of participants who received at least 1 dose of study agent.|||Participants|||Count of Participants
2530822|NCT03371381|Secondary|Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are defined as adverse events with onset or worsening on or after date of first dose of study treatment.|Up to 6.8 months|Safety analysis set included participants who received at least 1 administration of any study medication.|||Participants|||Count of Participants
2530823|NCT03371381|Secondary|Phase 1b: Number of Participants With Overall Survival (OS) Event (Died)|Number of participants with OS event (died) were reported. Overall Survival was defined as the duration from the date of randomization to the date of participant's death due to any cause.|Up to 6.8 months|The all treated analysis population consisted of participants who received at least 1 dose of study agent.|||Participants|||Count of Participants
2530824|NCT03371381|Secondary|Phase 1b: Number of Participants With Progression-free Survival (PFS) Event (Progressed or Died Before Progression)|"Number of participants with PFS event (progressed or died before progression) were reported. PFS - time from date of randomization until date of first documented evidence of PD (or relapse for participants who experience CR during study) or death from any cause, whichever comes first. RECIST for PD - sum of diameters had increased by >= 20% and >=5 mm from nadir (including baseline if it was smallest sum). Participants with measurable disease: for unequivocal progression based on non-target disease, there was an overall level of substantial worsening that merits discontinuation of therapy (if target disease is SD/PR). Participants without measurable disease: for unequivocal progression of non-target disease, increase in overall tumor burden must be comparable to increase required for PD of measurable disease. Furthermore, appearance of 1 or more new lesions or unequivocal progression of a non-target lesion."|Up to 6.8 months|The all treated analysis population consisted of participants who received at least 1 dose of study agent.|||Participants|||Count of Participants
2530825|NCT03371381|Secondary|Phase 1b: Duration of Objective Response (DOR)|"Duration of objective response was defined as the time from initial documentation of a response (CR or PR) to first documented date of disease progression (PD) or death from any cause. RECIST for PD - sum of diameters had increased by >= 20% and >=5 mm from nadir (including baseline if it was smallest sum). Participants with measurable disease: for unequivocal progression based on non-target disease, there was an overall level of substantial worsening that merits discontinuation of therapy (if target disease is stable disease [SD]/PR). Participants without measurable disease: for unequivocal progression of non-target disease, increase in overall tumor burden must be comparable to increase required for PD of measurable disease. Furthermore, appearance of 1 or more new lesions or unequivocal progression of a non-target lesion."|Up to 6.8 months|The all treated analysis population consisted of participants who received at least 1 dose of study agent. Overall number of participants analyzed is zero, since none of the participants had objective response.||||||
2530826|NCT03371381|Primary|Phase 1b: Percentage of Participants With Objective Response|Objective response rate was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST). RECIST for CR - disappearance of all lesions; all lymph nodes were non-pathological in size and normalization of tumor marker level; PR - greater than or equal to (>=) 30 percent (%) decrease in the sum of the diameters of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of nontarget lesions.|Up to 6.8 Months|The all treated analysis population consisted of participants who received at least 1 dose of study agent.|||Percentage of participants|||Number
2530827|NCT03370536|Secondary|Total Procedure Time|Total duration of RF ablation/fluoroscopy time/exposure procedure time|within 24 hours after the procedure is completed the time is calculated|Participant screen failed||||||
2530828|NCT03370536|Secondary|AF Termination Rate|AF termination rate is defined as AF termination to AT/SR (Atrial Tachycardia/Sinus Rhythm)|post ablation inducibility of AF after 5 minutes of burst pacing|Participant screen failed||||||
2530829|NCT03370536|Secondary|Percent Change of Driver Regions|Percent change of driver regions after ibutilide|Baseline and 1 year|Participant screen failed||||||
2530830|NCT03370536|Secondary|Size of Drivers|Size of drivers ablated|Baseline|Participant screen failed||||||
2530831|NCT03370536|Secondary|Number of Drivers|Number of drivers identified|Baseline|Participant screen failed||||||
2530832|NCT03370536|Primary|Number of Participants Who no Longer Has Recurrent At/AF|Freedom from recurrent At/AF|at 12 months|Participant screen failed||||||
2530833|NCT03370419|Primary|Self-reported Behavioral Automaticity Index|Habit strength, operationalized as changes in behavioral automaticity, were measured using a 1-7-point Likert scale. Participants respond to 4 stem statements. The scale thus ranges from 4-28. Higher score indicated a stronger habit.|2 weeks|12 of the 24 participants who entered the trial dropped and as such there was only complete data on 12 participants.|||score on a scale||Standard Error|Mean
2530834|NCT03370289|Secondary|Mean Body Temperature at Specific Time Points After Vaccination||Baseline, Days 1, 2, 3, 4, 5, 6, 7, and 22 after the first vaccination, Days 1, 2, 3, 4, 5, 6, 7, and 22 after the second vaccination|Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.|||degree Celsius||Standard Deviation|Mean
2530835|NCT03370289|Secondary|Change From Baseline in Mean Respiratory Rate at 30 Minutes After Vaccination||Baseline, At 30 minutes after the first vaccination, and at 30 minutes after the second vaccination|Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Breaths per minutes||Standard Deviation|Mean
2530836|NCT03370289|Secondary|Change From Baseline in Mean Pulse Rate at Specific Time Points After Vaccination||At 30 minutes after the first vaccination and on Day 22 after the first vaccination, and at 30 minutes after the second vaccination and on Day 22 after the second vaccination|Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Beats per minutes||Standard Deviation|Mean
2530837|NCT03370289|Secondary|Change From Baseline in Mean Diastolic Blood Pressure at Specific Time Points After Vaccination||Baseline, At 30 minutes after the first vaccination and on Day 22 after the first vaccination, and at 30 minutes after the second vaccination and on Day 22 after the second vaccination|Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.|||mmHg||Standard Deviation|Mean
2530838|NCT03370289|Secondary|Change From Baseline in Mean Systolic Blood Pressure at Specific Time Points After Vaccination||Baseline, At 30 minutes after the first vaccination and on Day 22 after the first vaccination, and at 30 minutes after the second vaccination and on Day 22 after the second vaccination|Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.|||mmHg||Standard Deviation|Mean
2530839|NCT03370289|Secondary|Number of Participants With Adverse Events Related to Solicited Local and Systemic Adverse Events to be Recorded in the Participant Diary|Local reactions and systemic events were recorded using a diary.|Up to Day 43|Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
2530953|NCT03365934|Primary|Microbial Community Richness - (Day 6)|Swabs will be collected on the back at Day 6 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.|Day 6||||Number of bacterial taxa||95% Confidence Interval|Mean
2530840|NCT03370289|Secondary|Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to Day 43|Safety Analysis Set (SAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
2530841|NCT03370289|Secondary|Geometric Mean Titer (GMT) of SRH Antibody Titer for the Vaccine Strain at 21 Days After Each Vaccination|GMT was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after first and second vaccination.|Day 22, and Day 43 (21 days after the first and the second vaccination)|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||mm^2||95% Confidence Interval|Geometric Mean
2530842|NCT03370289|Secondary|GMFI in SRH Antibody Titer From Baseline for the Vaccine Strain at 21 Days After the First Vaccination|GMFI was measured as geometric mean fold change from baseline in SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after first vaccination.|Day 22 (21 days after the first vaccination)|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Fold change||95% Confidence Interval|Geometric Mean
2530843|NCT03370289|Secondary|Seroconversion Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 Days After the First Vaccination|Seroconversion rate was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after first vaccination. Seroconversion rate as SRH antibody titer is defined as the percentage of participants with a 50% or more increase in SRH antibody titer from baseline for those who have a baseline value >4 mm^2 or SRH antibody titer ≥25 mm^2 for those who have a baseline value ≤4 mm^2.|Day 22 (21 days after the first vaccination)|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Percentage of participants||95% Confidence Interval|Number
2530844|NCT03370289|Secondary|Seroprotection Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 Days After the First Vaccination|Seroprotection rate was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after first vaccination. Seroprotection rate as SRH antibody titer is defined as the percentage of participants with SRH antibody titer ≥25 mm^2.|Day 22 (21 days after the first vaccination)|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Percentage of participants||95% Confidence Interval|Number
2530845|NCT03370289|Primary|Geometric Mean Fold Increase (GMFI) in SRH Antibody Titer From Baseline for the Vaccine Strain at 21 Days After the Second Vaccination|GMFI was measured as geometric mean fold change from baseline in SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after second vaccination.|Day 43 (21 days after the second vaccination)|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Fold change||95% Confidence Interval|Geometric Mean
2530846|NCT03370289|Primary|Seroconversion Rate as Measured by SRH Antibody Titer for the Vaccine Strain at 21 Days After the Second Vaccination|Seroconversion rate was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after second vaccination. Seroconversion rate as SRH antibody titer is defined as the percentage of participants with a 50% or more increase in SRH antibody titer from baseline for those who have a baseline value >4 mm^2 or SRH antibody titer ≥25 mm^2 for those who have a baseline value ≤4 mm^2.|Day 43 (21 days after the second vaccination)|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Percentage of participants||95% Confidence Interval|Number
2530847|NCT03370289|Primary|Seroprotection Rate as Measured by Single Radial Hemolysis (SRH) Antibody Titer for the Vaccine Strain at 21 Days After the Second Vaccination|Seroprotection rate was measured by SRH antibody titer for BLB-750 Qinghai RG strain at 21 days after second vaccination. Seroprotection rate as SRH antibody titer is defined as the percentage of participants with SRH antibody titer ≥25 mm^2.|Day 43 (21 days after the second vaccination)|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Percentage of participants||95% Confidence Interval|Number
2530848|NCT03370042|Secondary|Recession Width|mesial gingival margin to distal gingival margin at cemento enamel junction|12 months||||mm||Standard Deviation|Mean
2530849|NCT03370042|Secondary|Probing Depth|gingival margin to the base of the sulcus|12 months||||mm||Standard Deviation|Mean
2530850|NCT03370042|Secondary|Clinical Attachment Level|combined probing depth and recession height|12 months||||mm||Standard Deviation|Mean
2530851|NCT03370042|Primary|Width of Keratinized Tissue|measured from most apical part of gingival recession to the mucogingival junction|12 months||||mm||Standard Deviation|Mean
2530852|NCT03370042|Primary|Recession Height|measured from cemento enamel junction to the most apical part of gingival margin|12 months||||mm||Standard Deviation|Mean
2530853|NCT03369704|Secondary|Free IgE and Total IgE|Blood samples were collected Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and follow-up investigation were conducted 20/22 weeks after 12 week-treatment epoch|Day 1, at Day 29, Day 57, Day 85 and 24 weeks after last dose|Pharmacokinetic set (PK set): The PK set consisted of all randomized patients who received at least 1 dose of study drug and had at least 1 evaluable PK measurement. Patients in the PK set were analyzed according to the treatment they actually received.|||ng/mL||Standard Deviation|Mean
2530854|NCT03369704|Secondary|Serum Trough Omalizumab Concentration|Blood samples were collected Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and follow-up investigation which were conducted 20/22 weeks after 12 week-treatment epoch|Prior to first dosing (Day 1), at Day 29, Day 57, Day 85 and 24 weeks after last dose|Pharmacokinetic set (PK set): The PK set consisted of all randomized patients who received at least 1 dose of study drug and had at least 1 evaluable PK measurement. Patients in the PK set were analyzed according to the treatment they actually received.|||μg/mL||Standard Deviation|Mean
2530954|NCT03365934|Primary|Microbial Community Richness - (Day 5)|Swabs will be collected on the back at Day 5 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.|Day 5||||Number of bacterial taxa||95% Confidence Interval|Mean
2530855|NCT03369704|Secondary|Number of Participants With Anti-omalizumab Antibodes|Number of participants with antibodies against the Fab and Fc region of omalizumab in serum.|Prior to first dosing (Day 1), At follow-up investigation which were conducted 20/22 weeks after 12 week-treatment epoch|Safety set (SAF): The SAF consisted of all patients who received at least 1 dose of study drug. Patients in the SAF were analyzed according to treatment actually received.|||participants|||Number
2530856|NCT03369704|Secondary|Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ, No1) Score|Nasal and eye symptoms (JRQLQ I) included 6 categories: Runny nose, Sneezing, Nasal congestion, Itchy nose, itchy eyes and watery eyes, on a 5-point scale of 0 to 4 (no symptoms to very severe symptoms). JRQLQ I score was a mean of these 6 categories. JRQLQ II included 17 items on a 5-point scale, 0 to 4 (no significant problem to very greatly). JRQLQ II scores was a mean of these 17 items. Overall face scale (JRQLQ III) evaluated overall symptoms, condition and feelings on a 5-point scale from 0 to 4 (fine to crying). Evaluation visit was defined as follows independently for each evaluation item and for each patient: 1) If there was a single visit during the severe symptom period, the visit was the evaluation visit. 2) If there were ≥ 2 visits during the severe symptom period and a) if Visit 105 was one of them, Visit 105 was the evaluation visit; b) if Visit 105 was outside the period, the closest visit to Visit 105 during the period was the evaluation visit.|Evaluation Visit, one visit during severe symptom period (23-Feb-2018 to 24-Mar-2018) for each patient|Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug.|||Score||Standard Error|Least Squares Mean
2530857|NCT03369704|Secondary|Number of Rescue Medication Used|Amount number of rescue medication used (a total number of times used).|Severe symptom period (from 23Feb2018 to 24Mar2018)|Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.|||Number of times used||Full Range|Median
2530858|NCT03369704|Secondary|Rescue Medication Free Days|"Number of days with no rescue medication (tramazoline hydrochloride, levocabastine hydrochloride).~Nasal ocular rescue medication free days were defined as the days with no use of tramazoline hydrochloride (nasal rescue medication) and levocabastine hydrochloride (ocular rescue medication)."|Severe symptom period (from 23Feb2018 to 24Mar2018)|Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.|||days||Full Range|Median
2530859|NCT03369704|Secondary|Rescue Medication Score|"Rescue medication scores were given for tramazoline hydrochloride (nasal, 1 point) and levocabastine hydrochloride (ocular, 1 point).~Rescue medication score for nasal is medication score for Tramazoline hydrochloride, Rescue medication score for ocular is medication score for Levocabastine hydrochloride and Rescue medication score for nasal and ocular is the sum of medication score for Tramazoline hydrochloride and Levocabastine hydrochlorid"|Severe symptom period (from 23Feb2018 to 24Mar2018)|Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.|||score||Standard Error|Least Squares Mean
2530860|NCT03369704|Secondary|Completely Nasal Symptom Free Patients|Completely nasal symptom free patients is the number of patients who were nasal symptom free (all nasal symptoms were not more than mild in severity) on all non-missing days and had nasal symptom scores for at least 26 days during the 30 days of severe symptom period.|Severe symptom period (from 23Feb2018 to 24Mar2018)|Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.|||Participants|||Count of Participants
2530861|NCT03369704|Secondary|Number of Symptom Free Days|Nasal symptom free days (days with all nasal symptoms are not more than mild in severity) during the severe symptom period. Ocular symptom free days (days with all ocular symptoms are not more than mild in severity) during the severe symptom period.|Severe symptom period (from 23Feb2018 to 24March2018)|Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.|||days||Full Range|Median
2530862|NCT03369704|Secondary|Mean Score for Impairment of Daily Activities|Impairment of daily activities were evaluated on a scale of 0 (none) to 4 (intense/severe).|Severe symptom period (from 23Feb2018 to 24Mar2018)|Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.|||score||Standard Error|Least Squares Mean
2530863|NCT03369704|Secondary|Mean Score for Severity of Itchy and Watery Eye|Symptoms of itchy and watery eye were evaluated on a scale of 0 (none) to 4 (intense/severe).|Severe symptom period (from 23Feb2018 to 24Mar2018)|Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.|||score||Standard Error|Least Squares Mean
2530864|NCT03369704|Secondary|Mean Score for Severity of Sneezing, Rhinorrhea and Nasal Congestion|Symptoms of sneezing, rhinorrhea and nasal congestion were evaluated on a scale of 0 (none) to 4 (intense/severe).|Severe symptom period (from 23Feb2018 to 24Mar2018)|Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.|||score||Standard Error|Least Squares Mean
2530878|NCT03369340|Secondary|Trough Plasma Nicotine Concentration [Ctrough]|To measure the trough plasma nicotine concentration [Ctrough] of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels.|Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4|Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.|||ng/mL||95% Confidence Interval|Geometric Least Squares Mean
2530955|NCT03365934|Primary|Microbial Community Richness - (Day 4)|Swabs will be collected on the back at Day 4 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.|Day 4||||Number of bacterial taxa||95% Confidence Interval|Mean
2530865|NCT03369704|Secondary|Mean Nasal Symptom Medication Score, Mean Ocular Symptom Medication Score, and Mean Nasal Ocular Symptom Medication Score|"Medication scores were given for fluticasone propionate (nasal, 2 point), fexofenadine hydrochloride (oral, 1 point), tramazoline hydrochloride (nasal, 1 point), and levocabastine hydrochloride (ocular, 1 point). Symptom medication score consisted of severe symptom period.~Nasal symptom medication score is the sum of nasal symptom score and medication score (fexofenadine hydrochloride, fluticasone propionate, tramazoline hydrochloride) Ocular symptom medication score is the sum of ocular symptom score and medication score (fexofenadine hydrochloride, levocabastine hydrochloride) Nasal ocular symptom medication score is the sum of nasal symptom score, ocular symptom score and medication score (fexofenadine hydrochloride, fluticasone propionate, tramazoline hydrochloride, levocabastine hydrochloride)."|Severe symptom period (from 23Feb2018 to 24Mar2018)|Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.|||score||Standard Error|Least Squares Mean
2530866|NCT03369704|Secondary|Mean Ocular Symptom Score and Mean Nasal Ocular Symptom Score|"Ocular symptoms (itchy and watery eye) were recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 4 (intense/severe). Ocular symptom score (0-8 point) consisted of score for severity of itchy eye (0-4 point) and watery eye (0-4 point).~Nasal ocular symptom score consisted of nasal symptom score and ocular symptom score.~Nasal ocular symptom score is the sum of nasal symptom score (0-12) and ocular symptom score (0-8) 0 presents no nasal ocular symptom and 20 presents worse outcome."|Severe symptom period (from 23Feb2018 to 24Mar2018)|Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.|||Score||Standard Error|Least Squares Mean
2530867|NCT03369704|Primary|Mean Nasal Symptom Score|"Nasal symptoms (sneezing, rhinorrhea and nasal congestion) were recorded by the patient everyday in their e-Diary, on a scale of 0 (none) to 4 (intense/severe). Nasal symptom score (0-12 point) consisted of score for severity of sneezing (0-4 point), rhinorrhea (0-4 point) and nasal congestion (0-4 point).~Severe symptom period: The three weeks where the cumulative value of the mean daily nasal symptom score is the maximum. The three weeks must also meet one of the following criteria: 2) ≥ 70% of the period with concomitant use of fluticasone propionate is included in this three weeks. 2) ≥ 70% of this three weeks includes the period with concomitant use of fluticasone propionate. If not, severe symptom period was extended at a minimum to meet one of the criteria above. The severe symptom period will be defined as: the three weeks where the cumulative value of the mean daily nasal symptom score will be the maximum."|Severe symptom period (from 23Feb2018 to 24March2018)|Full analysis set (FAS): The FAS consisted of all patients in the RAN who received at least 1 dose of study drug. Among patients in the FAS, those who had nasal symptom scores for at least 50% of days during the severe symptom period were included.|||score||Standard Error|Least Squares Mean
2530868|NCT03369340|Secondary|Amount of Powder Aerosolized From P3P From the ad Libitum Use Period (Per Product Used).|P3P weight before use, and after use, to determine the amount of powder aerosolized from P3P during Ad Libitum use (per product used).|Before and after ad libitum product use on days 1, 2, 3 and 4||||mg||Standard Deviation|Mean
2530869|NCT03369340|Secondary|Amount of Powder Aerosolized From P3P From the Fixed Puffing Regimen.|Descriptive statistics of P3P weight before use, and after use, for the fixed puffing regimen.|Before and after fixed puffing product use on days 1, 2, 3 and 4||||mg||Standard Deviation|Mean
2530870|NCT03369340|Secondary|Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the ad Libitum Use Period.|Descriptive statistics of total puff volume and average puff volume, of four P3P variants, during the ad libitum use period.|During ad libitum product use on days 1, 2, 3 and 4||||mL||95% Confidence Interval|Geometric Mean
2530871|NCT03369340|Secondary|Human Puffing Topography (HPT) Parameters (Puff Volume) of Four P3P Variants During the Fixed Puffing Regimen Period.|Descriptive statistics of total puff volume and average puff volume, of four P3P variants, during the fixed puffing regimen period.|During fixed puffing product use on days 1, 2, 3 and 4||||mL||95% Confidence Interval|Geometric Mean
2530872|NCT03369340|Secondary|Sensory Parameters|Measured with a Sensory Questionnaire (SQ) following the ad libitum use period. Response to each question is assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).|Within 60 minutes after the ad libitum use session on days 1, 2, 3 and 4||||score on a scale||95% Confidence Interval|Least Squares Mean
2530873|NCT03369340|Secondary|Product Evaluation|Measured with an adapted version of the modified Cigarette Evaluation Questionnaire (adapted mCEQ) following the ad libitum use period. Assessed on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).|Within 60 minutes after the ad libitum use session on days 1, 2, 3 and 4||||score on a scale||95% Confidence Interval|Least Squares Mean
2530874|NCT03369340|Secondary|AUC Craving for a Cigarette During and After the ad Libitum Use Period|Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving).|During and up to 4 hours post-product use on days 1, 2, 3 and 4||||score on a scale (millimetres)*h||95% Confidence Interval|Least Squares Mean
2530875|NCT03369340|Secondary|AUC of Craving for a Cigarette During and After the Fixed Puffing Regimen|Measured on a Visual Analogue Scale (VAS) of 0 (no craving) to 100 (strong craving).|During and up to 4 hours post-product use on days 1, 2, 3 and 4||||score on a scale (millimetres)*h||95% Confidence Interval|Least Squares Mean
2530876|NCT03369340|Secondary|Area Under the Concentration-time Curve From Start of Product Use (T0 ad Lib) to 4 Hours [AUCad Lib (0-4h)]|To measure the area under the plasma concentration-time curve of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels.|Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4|Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.|||ng/mL*h||95% Confidence Interval|Geometric Least Squares Mean
2530877|NCT03369340|Secondary|Average of Plasma Nicotine Concentration From T0 ad Lib to 1 Hour [Caverage]|To measure the average of plasma nicotine concentration [Caverage], of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels|Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour during ad libitum use) on Days 1, 2, 3 and 4|Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.|||ng/mL||95% Confidence Interval|Geometric Least Squares Mean
2530879|NCT03369340|Secondary|Time to Peak Plasma Nicotine Concentration [Tpeak]|To measure the time to peak plasma nicotine concentration [Tpeak] of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels.|Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4|Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.|||minutes||Standard Deviation|Mean
2530880|NCT03369340|Secondary|Peak Plasma Nicotine Concentration [Cpeak]|To measure the Peak plasma nicotine concentration [Cpeak] of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels.|Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4|Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.|||ng/mL||95% Confidence Interval|Geometric Least Squares Mean
2530881|NCT03369340|Secondary|Plasma Nicotine Concentration-time Profile|To measure the plasma nicotine concentration-time profile of four P3P variants from the ad libitum use period, following correction of baseline nicotine levels.|Derived from multiple blood sampling (measured at 10 mins, 20 mins, 30 mins, 40 mins, 1 hour, 2 hours, and 4 hours during and post-ad libitum use) on Days 1, 2, 3 and 4|Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.|||ng/mL||95% Confidence Interval|Geometric Mean
2530882|NCT03369340|Primary|Area Under the Concentration-time Curve From Start of Product Use (T0 Fix) to 4 Hours [AUCfix (0-4h)]|To measure the area under the plasma concentration-time curve of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.|Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4|Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.|||ng/mL*h||95% Confidence Interval|Geometric Least Squares Mean
2530883|NCT03369340|Primary|Time to the Maximum Nicotine Concentration [Tmax]|To measure the time to maximum nicotine concentration [Tmax] of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.|Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4|Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.|||minutes||Full Range|Median
2530884|NCT03369340|Primary|Maximum Plasma Concentration [Cmax]|To measure the maximum nicotine plasma concentration [Cmax] of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.|Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4|Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects|||ng/mL||95% Confidence Interval|Geometric Least Squares Mean
2530885|NCT03369340|Primary|Plasma Nicotine Concentration-time Profile|To measure the plasma nicotine concentration-time profile of four P3P variants from the fixed puffing regimen, following correction of baseline nicotine levels.|Derived from multiple blood sampling (measured at 2 mins, 4 mins, 7 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hours, and 4 hours post-product use) on Days 1, 2, 3 and 4|Baseline correction of nicotine concentrations could be performed for 16 out of the 18 randomized subjects.|||ng/mL||95% Confidence Interval|Geometric Mean
2530886|NCT03368937|Primary|System Suitability|Technology Acceptance Questionnaire Score Scores are on a Likert Scale of 1-Not at All to 5-Extremely for Ease of Use, Usability and Trust in System Scores.|36-48 hours||||score on a scale||Full Range|Mean
2530887|NCT03368807|Secondary|Average Number of Missed and Suboptimal Bolus Dose (MSBD) Events Per Month With Unblinded CGM|The number of Missed and Suboptimal Doses (MSBDs) per month was calculated in participants with Type 1 Diabetes or Type 2 Diabetes as the sum of the identified missed bolus doses and suboptimal bolus doses for each participant for each period.|Week 6 up to 12 weeks|All enrolled participants who received at least one dose of study drug and have data for missed bolus doses.|||Dose per month||Standard Deviation|Mean
2530888|NCT03368807|Secondary|Average Number of Missed and Suboptimal Bolus Dose (MSBD) Events Per Month With Blinded CGM|The number of Missed and Suboptimal Doses (MSBDs) per month was calculated in participants with Type 1 Diabetes or Type 2 Diabetes as the sum of the identified missed bolus doses and suboptimal bolus doses for each participant for each period.|Baseline up to 6 weeks|All enrolled participants who received at least one dose of study drug and have data for missed bolus doses.|||Dose per month||Standard Deviation|Mean
2530889|NCT03368807|Secondary|Average Number of Missed Bolus Insulin Doses Per Day With Unblinded CGM|The average number of missed bolus doses per day was estimated in participants with Type 1 diabetes or Type 2 diabetes using unblinded CGM data.|Week 6 up to 12 weeks|All enrolled participants who received at least one dose of study drug and have data for missed bolus doses.|||Dose per day||Standard Deviation|Mean
2530890|NCT03368807|Secondary|Average Number of Missed Bolus Insulin Doses Per Day With Blinded CGM|The average number of missed bolus doses per day was estimated in participants with Type 1 diabetes or Type 2 diabetes using blinded CGM measurements and the pen.|Baseline up to 6 weeks|All enrolled participants who received at least one dose of study drug and have data for missed bolus doses.|||Dose per day||Standard Deviation|Mean
2530891|NCT03368807|Secondary|Percentage of Missed Bolus Doses Per Month With Unblinded CGM|Percentage of missed bolus doses per month was estimated in participants with Type 1 diabetes or Type 2 diabetes using unblinded CGM measurements and the pen.|Week 6 up to 12 weeks|All enrolled participants who received at least one dose of study drug and have data for missed bolus doses.|||Percentage of missed bolus dose||Standard Deviation|Mean
2530892|NCT03368807|Secondary|Percentage of Missed Bolus Doses Per Month With Blinded CGM|Percentage of missed bolus doses per month was estimated in participants with Type 1 diabetes or Type 2 diabetes using blinded CGM measurements and the pen.|Baseline up to 6 weeks|All enrolled participants who received at least one dose of study drug and have data for missed bolus doses.|||Percentage of missed bolus dose||Standard Deviation|Mean
2530950|NCT03365934|Primary|Microbial Community Diversity - Baseline (Day 0)|Swabs will be collected on the back at Baseline (Day 0) for analysis based on the Shannon Index.|Baseline (Day 0)||||Shannon Diversity Index||95% Confidence Interval|Mean
2546972|NCT02915029|Secondary|Diastolic Blood Pressure|Changes in diastolic blood pressure on study.|12 months minus baseline values||||mm Hg||Standard Deviation|Mean
2530893|NCT03368807|Secondary|Percentage of Time-in-Range (Glucose >70 and ≤180 Milligrams Per Deciliter) With Unblinded CGM|Percentage of time-in-range (glucose >70 and ≤180 milligrams per deciliter) was calculated in participants with Type 1 Diabetes or Type 2 Diabetes based on unblinded CGM data collected in the study period. The time component of the time-in-range statistic was calculated using the display time recorded by the CGM device.|Week 6 up to 12 weeks|All enrolled participants who received at least one dose of study drug and have data for Percentage of Time-in-Range.|||Percentage of time||Standard Deviation|Mean
2530894|NCT03368807|Secondary|Percentage of Time-in-Range (Glucose >70 and ≤180 Milligrams Per Deciliter) With Blinded CGM|Percentage of time-in-range (glucose >70 and ≤180 milligrams per deciliter) was calculated in participants with Type 1 Diabetes or Type 2 Diabetes based on blinded CGM data collected in the study period. The time component of the time-in-range statistic was calculated using the display time recorded by the CGM device.|Baseline up to 6 weeks|All enrolled participants who received at least one dose of study drug and have data for Percentage of Time-in-Range.|||Percentage of time||Standard Deviation|Mean
2530895|NCT03368807|Secondary|Average Number of Days Per Month With a Missed Bolus Insulin Dose With Unblinded CGM|The average number of days per month with a missed bolus insulin dose was calculated in participants with Type 1 Diabetes or Type 2 Diabetes using unblinded CGM measurements and the pen. The time of insulin dosing and glucose excursions were assessed using the display times recorded by the pen and CGM devices, respectively|Week 6 up to 12 weeks|All enrolled participants who received at least one dose of study drug and have missed bolus insulin dose data.|||Days per month||Standard Deviation|Mean
2530896|NCT03368807|Primary|Average Number of Days Per Month With a Missed Bolus Insulin Dose With Blinded CGM|The average number of days per month with a missed bolus insulin dose was calculated in participants with Type 1 Diabetes or Type 2 Diabetes using blinded CGM measurements and the pen. The time of insulin dosing and glucose excursions were assessed using the display times recorded by the pen and CGM devices, respectively.|Week 1 up to 6 weeks|All enrolled participants who received at least one dose of study drug and have missed bolus insulin dose data.|||Days per month||Standard Deviation|Mean
2530897|NCT03368170|Other Pre-specified|Change in Daily Hours Spent in ON-time With Troublesome Dyskinesia as Assessed by 24-hour Patient Diaries|"Change in ON-time with troublesome dyskinesia as assessed by patient completed 24-hour diaries, from run-in to visit 4. This is a self administered diary where patients assess their motor state every half hour during 24 hours.~The different motor states assessed: ON, ON with troublesome dyskinesia, OFF and asleep."|Run-in and 4 weeks|Full analysis set (all randomized and treated patients who received one or more doses and who provided post baseline data whether or not they fully complied with the requirements of the protocol).|||daily hours||95% Confidence Interval|Least Squares Mean
2530898|NCT03368170|Secondary|Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part II and III|Change in MDS-UPDRS sum score of parts II+III (Motor aspects of Experiences of Daily living + Motor Examination) from baseline to visit 4. Minimum value is 0 and maximum value is 124. Higher score mean a worse outcome.|Baseline and 4 weeks|Full analysis set (all randomized and treated patients who received one or more doses and who provided post baseline data whether or not they fully complied with the requirements of the protocol).|||score on a scale||95% Confidence Interval|Least Squares Mean
2530899|NCT03368170|Secondary|Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV, Question 4.1 and 4.2|Change in MDS-UPDRS sum score of questions 4.1 (Time spent with dyskinesias) and 4.2 (Functional impact of dyskinesias) in part IV from baseline to visit 4. Minimum score is 0 and maximum score is 8. A higher score means more dyskinesia.|Baseline and 4 weeks|Full analysis set (all randomized and treated patients who received one or more doses and who provided post baseline data whether or not they fully complied with the requirements of the protocol).|||score on a scale||95% Confidence Interval|Least Squares Mean
2530900|NCT03368170|Primary|Unified Dyskinesia Rating Scale (UDysRS)|The change from baseline to day 28 of treatment (Visit 4) in the sum of the items comprising the Unified Dyskinesia Rating Scale (UDysRS). The Unified Dyskinesia Rating Scale (UDysRS) is administered to assess dyskinesia. The scoring range is 0-104, where higher score means more dyskinesia.|Baseline and 4 weeks|Full analysis set (all randomized and treated patients who received one or more doses and who provided post baseline data whether or not they fully complied with the requirements of the protocol).|||score on a scale||95% Confidence Interval|Least Squares Mean
2530901|NCT03368053|Secondary|Number of Vaccine Responders for HIV-1-specific CD8+ T-cells Expressing at Least 2 Cytokine Markers|Vaccine response rates for HIV-1-specific CD8+ T cells expressing at least two markers among CD40L, IL-2, TNF-α and IFN-γ with responders were defined as subjects with: a 2-fold increase as compared to the cut-off (=354, limit of quantification [LOQ] of the assay), for subjects with pre-vaccination frequency below the cut-off, at Day 0, OR at least 2-fold increase as compared to pre- vaccination frequency, for subjects with pre-vaccination frequency above the cut-off.|At Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14|Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.|||Participants|||Count of Participants
2530902|NCT03368053|Secondary|Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific CD8+ T-cells Expressing at Least 2 Cytokine Markers|Assessed cytokines include: CD40-L, IL2, TNF-α, INF-γ, by ICS. CD8+ T-cells were expressed in CD8+ T-cells/million cells/million cells.|At Day 0, Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14|Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
2530903|NCT03368053|Secondary|Number of Vaccine Responders for HIV-1-specific CD4+ T-cells Expressing at Least 2 Cytokine Markers|Vaccine response rates for HIV-1-specific CD4+ T cells expressing at least two markers among CD40L, IL-2, TNF-α and IFN-γ with responders were defined as subjects with: a 2-fold increase as compared to the cut-off (=354, limit of quantification [LOQ] of the assay), for subjects with pre-vaccination frequency below the cut-off, at Day 0, OR at least 2-fold increase as compared to pre-vaccination frequency, for subjects with pre-vaccination frequency above the cut-off.|At Day 98 and at Day 672 historical time points of PRO-HIV-002 and at Year 14|Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.|||Participants|||Count of Participants
2530904|NCT03368053|Secondary|Frequency of Human Immunodeficiency Virus Type 1 (HIV-1) Specific Cluster of Differentiation-4 (CD4+) T Cells Expressing at Least 2 Cytokine Markers|Assessed cytokines include: cluster of differentiation-40 lingand (CD40-L), Interleukin-2 (IL2), Tumour Necrosis Factor-alpha (TNF-α), Interferon-gamma (INF-γ), by Intracellular Cytokine Staining (ICS). CD4+ T-cells were expressed in CD4+ T-cells/million cells.|At Day 0, Day 98, Day 672 historical time points of PRO-HIV-002 and at Year 14|Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
2530905|NCT03368053|Secondary|Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Magnitude for Analytes Not Part of Any Breadth Panel|"Whenever results were provided as Mean Fluorescence Intensity (MFI), the statistical outputs BAMA response magnitude (MFI) terminology is used instead of concentrations/titres. Analysis was performed on the gp120 antigen (IgG1, IgG2, IgG3 and IgG4) for the following vaccine HIV strains: which were not part of any breadth panel: 1086C_D7gp120.avi/293F IgG, Con 6 gp120/B IgG, and gp120 (Clone W6.1D) IgG. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed."|At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14|Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.|||MFI||95% Confidence Interval|Geometric Mean
2530906|NCT03368053|Secondary|Number of Subjects With Anti-gp120 (IgG1, IgG2, IgG3 and IgG4) BAMA Response Call for Analytes Not Part of Any Breadth Panel|"To comply with BAMA methodology and terminology, the wording BAMA response call status was used instead of seropositivity in the analysis. Compared to baseline result (Day 0), a sample is called positive for a given analyte if the response magnitude is equal to or above (≥) the analyte specific cutoff from all baseline samples in the study (where the cutoff is the 95th percentile of the baseline response, or 100, whichever is higher) OR ≥3 times the response magnitude as compared to the sample specific baseline.Analysis was performed on the gp120 antigen (IgG1, IgG2, IgG3 and IgG4) for the following vaccine HIV strains which were not part of any breadth panel: 1086C_D7gp120.avi/293F IgG, Con 6 gp120/B IgG, and gp120 (Clone W6.1D) IgG. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed."|At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14|Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.|||Participants|||Count of Participants
2530907|NCT03368053|Secondary|Anti-gp 120 Total IgG Antibody BAMA Response Magnitude|"Whenever results were provided as Mean Fluorescence Intensity (MFI), the statistical outputs BAMA response magnitude (MFI) terminology is used instead of concentrations/titres. The strains: 086C_D7gp120.avi/293F IgG, Con 6 gp120/B IgG, and gp120 (Clone W6.1D) IgG were not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed."|At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14|Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.|||MFI||95% Confidence Interval|Geometric Mean
2530908|NCT03368053|Secondary|Number of Subjects With Anti-envelope Glycoprotein (Anti-gp) 120 Total IgG BAMA Response Call|"To comply with BAMA methodology and terminology, the wording BAMA response call status was used instead of seropositivity in the analysis. Compared to baseline result (Day 0), a sample is called positive for a given analyte if the response magnitude is equal to or above (≥) the analyte specific cutoff from all baseline samples in the study (where the cutoff is the 95th percentile of the baseline response, or 100, whichever is higher) OR ≥3 times the response magnitude as compared to the sample specific baseline. The strains: 086C_D7gp120.avi/293F IgG, Con 6 gp120/B IgG, and gp120 (Clone W6.1D) IgG were not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed."|At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14|Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.|||Participants|||Count of Participants
2530909|NCT03368053|Primary|Anti-V1V2 IgG1, IgG2, IgG3 and IgG4 Antibody BAMA Response Magnitude|"Whenever results were provided as Mean Fluorescence Intensity (MFI), the statistical outputs BAMA response magnitude (MFI) terminology is used instead of concentrations/titres. Antigen IgG3 was assessed for all strains. Antigens IgG1, IgG2 and IgG4 were assessed only for C.1086C_V1_V2 Tags strain that was not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed."|At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14|Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.|||MFI||95% Confidence Interval|Geometric Mean
2530910|NCT03368053|Primary|Number of Subjects With Anti-V1V2 Subtypes Range: IgG1, IgG2, IgG3 and IgG4 Response Call|"To comply with BAMA methodology and terminology, the wording BAMA response call status was used instead of seropositivity in the analysis. Compared to baseline result (Day 0), a sample is called positive for a given analyte if the response magnitude is equal to or above (≥) the analyte specific cutoff from all baseline samples in the study (where the cutoff is the 95th percentile of the baseline response, or 100, whichever is higher) OR ≥3 times the response magnitude as compared to the sample specific baseline. Antigen IgG3 was assessed for all strains. Antigens IgG1, IgG2 and IgG4 were assessed only for C.1086C_V1_V2 Tags strain that was not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed."|At Day 182, Day 672 historical time point of PRO-HIV-002 and at Year 14|Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.|||Participants|||Count of Participants
2546973|NCT02915029|Secondary|A1c|Changes in clinical values|12 months minus baseline values||||percentage||Standard Deviation|Mean
2530911|NCT03368053|Primary|Anti-V1V2 Total IgG Antibody BAMA Response Magnitude|"Whenever results were provided as Mean Fluorescence Intensity (MFI), the statistical outputs BAMA response magnitude (MFI) terminology is used instead of concentrations/titres. The C.1086C_V1_V2 Tags strain was not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed."|At Day 0, Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14|Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.|||MFI||95% Confidence Interval|Geometric Mean
2530912|NCT03368053|Primary|Number of Subjects With Anti-V1V2 Total Immunoglobulin G (IgG) Binding Antibody Multiplex Assay (BAMA) Response Call|"To comply with BAMA methodology and terminology, the wording BAMA response call status was used instead of seropositivity in the analysis. Compared to baseline result (Day 0), a sample is called positive for a given analyte if the response magnitude is equal to or above (≥) the analyte specific cutoff from all baseline samples in the study (where the cutoff is the 95th percentile of the baseline response, or 100, whichever is higher) OR ≥3 times the response magnitude as compared to the sample specific baseline. The C.1086C_V1_V2 Tags strain was not part of any breadth panel. Due to low or infrequent response, or undetectable levels of response among the breadth panel strains, some additional strains, not part of the breadth panels, were also analyzed."|At Day 182, Day 672 historical time points of PRO-HIV-002 and at Year 14|Analysis was performed on the Per-Protocol cohort for immunogenicity which included all subjects from the Total cohort who met all eligibility criteria, and who presented a negative HIV-RNA test at Y14.|||Participants|||Count of Participants
2530913|NCT03366207|Secondary|Microbiologic Response|Microbiologic response is defined as demonstrating <1000 colony-forming units per mL of the baseline uropathogen at the test of cure visit|From start of treatment until assessment of cure, approximately 12 days|Microbiological modified intent to treat|||Participants|||Count of Participants
2530914|NCT03366207|Primary|Number of Subjects With Combined Clinical and Microbiologic Response|Clinical response is defined as complete resolution of uUTI symptoms at entry and no new uUTI symptoms; microbiologic success is defined as eradication of baseline pathogen|From start of treatment until assessment of cure, approximately 12 days|Microbiological modified intent to treat population|||Participants|||Count of Participants
2530915|NCT03365934|Secondary|Redness: Wound Area Oxyhemoglobin Level - Day 14|Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.|Day 14||||Arbitrary Unit||Standard Deviation|Mean
2530916|NCT03365934|Secondary|Redness: Wound Area Oxyhemoglobin Level - Day 7|Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.|Day 7||||Arbitrary Unit||Standard Deviation|Mean
2530917|NCT03365934|Secondary|Redness: Wound Area Oxyhemoglobin Level - Day 6|Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.|Day 6||||Arbitrary Unit||Standard Deviation|Mean
2530918|NCT03365934|Secondary|Redness: Wound Area Oxyhemoglobin Level - Day 5|Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.|Day 5||||Arbitrary Unit||Standard Deviation|Mean
2530919|NCT03365934|Secondary|Redness: Wound Area Oxyhemoglobin Level - Day 4|Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.|Day 4||||Arbitrary Unit||Standard Deviation|Mean
2530920|NCT03365934|Secondary|Redness: Wound Area Oxyhemoglobin Level - Day 3|Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.|Day 3||||Arbitrary Unit||Standard Deviation|Mean
2530921|NCT03365934|Secondary|Redness: Wound Area Oxyhemoglobin Level - Day 2|Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.|Day 2||||Arbitrary Unit||Standard Deviation|Mean
2530951|NCT03365934|Primary|Microbial Community Richness - (Day 14)|Swabs will be collected on the back at Day 14 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.|Day 14||||Number of bacterial taxa||95% Confidence Interval|Mean
2530922|NCT03365934|Secondary|Redness: Wound Area Oxyhemoglobin Level - Day 1|Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.|Day 1||||Arbitrary Unit||Standard Deviation|Mean
2530923|NCT03365934|Secondary|Redness: Wound Area Oxyhemoglobin Level- Baseline (Day 0)|Quantification of oxy- and deoxy-hemoglobin at the wound area was achieved from apparent absorption spectrum acquired from diffuse reflectance spectroscopy (DRS) at the site. Absorption spectra of fully oxygenated and deoxygenated hemoglobin molecules were employed to quantify the contribution of each molecule to the total apparent absorption of the wounded skin in the spectral range of 560 nm -- 700 nm. The numbers of oxyhemoglobin are in arbitrary unit and higher values describe higher erythema levels.|Day 0||||Arbitrary Unit||Standard Deviation|Mean
2530924|NCT03365934|Secondary|Skin Barrier Function - Day 14|The skin barrier function of the test sites will be evaluated at Day 14 by Trans Epidermal Water Loss (TEWL).|Day 14||||g/m^2/hr||Standard Deviation|Mean
2530925|NCT03365934|Secondary|Skin Barrier Function - Day 7|The skin barrier function of the test sites will be evaluated at Day 7 by Trans Epidermal Water Loss (TEWL).|Day 7||||g/m^2/hr||Standard Deviation|Mean
2530926|NCT03365934|Secondary|Skin Barrier Function - Day 6|The skin barrier function of the test sites will be evaluated at Day 6 by Trans Epidermal Water Loss (TEWL).|Day 6||||g/m^2/hr||Standard Deviation|Mean
2530927|NCT03365934|Secondary|Skin Barrier Function - Day 5|The skin barrier function of the test sites will be evaluated at Day 5 by Trans Epidermal Water Loss (TEWL).|Day 5||||g/m^2/hr||Standard Deviation|Mean
2530928|NCT03365934|Secondary|Skin Barrier Function - Day 4|The skin barrier function of the test sites will be evaluated at Day 4 by Trans Epidermal Water Loss (TEWL).|Day 4||||g/m^2/hr||Standard Deviation|Mean
2530929|NCT03365934|Secondary|Skin Barrier Function - Day 3|The skin barrier function of the test sites will be evaluated at Day 3 by Trans Epidermal Water Loss (TEWL).|Day 3||||g/m^2/hr||Standard Deviation|Mean
2530930|NCT03365934|Secondary|Skin Barrier Function - Day 2|The skin barrier function of the test sites will be evaluated at Day 2 by Trans Epidermal Water Loss (TEWL).|Day 2||||g/m^2/hr||Standard Deviation|Mean
2530931|NCT03365934|Secondary|Skin Barrier Function - Day 1|The skin barrier function of the test sites will be evaluated at Day 1 by Trans Epidermal Water Loss (TEWL).|Day 1||||g/m^2/hr||Standard Deviation|Mean
2530932|NCT03365934|Secondary|Skin Barrier Function -Baseline (Day 0)|The skin barrier function of the test sites will be evaluated at Baseline (Day 0) by Trans Epidermal Water Loss (TEWL).|Day 0||||g/m^2/hr||Standard Deviation|Mean
2530933|NCT03365934|Primary|Microbial Community Evenness - Day 14|Swabs will be collected on the back at Day 14 for analysis based on the Pielou's Evenness Index.|Day 14||||Pielou's Evenness Index||95% Confidence Interval|Mean
2530934|NCT03365934|Primary|Microbial Community Evenness - Day 7|Swabs will be collected on the back at Day 7 for analysis based on the Pielou's Evenness Index.|Day 7||||Pielou's Evenness Index||95% Confidence Interval|Mean
2530935|NCT03365934|Primary|Microbial Community Evenness - Day 6|Swabs will be collected on the back at Day 6 for analysis based on the Pielou's Evenness Index.|Day 6||||Pielou's Evenness Index||95% Confidence Interval|Mean
2530936|NCT03365934|Primary|Microbial Community Evenness - Day 5|Swabs will be collected on the back at Day 5 for analysis based on the Pielou's Evenness Index.|Day 5||||Pielou's Evenness Index||95% Confidence Interval|Mean
2530937|NCT03365934|Primary|Microbial Community Evenness - Day 4|Swabs will be collected on the back at Day 4 for analysis based on the Pielou's Evenness Index.|Day 4||||Pielou's Evenness Index||95% Confidence Interval|Mean
2530938|NCT03365934|Primary|Microbial Community Evenness - Day 3|Swabs will be collected on the back at Day 3 for analysis based on the Pielou's Evenness Index.|Day 3||||Pielou's Evenness Index||95% Confidence Interval|Mean
2530939|NCT03365934|Primary|Microbial Community Evenness - Day 2|Swabs will be collected on the back at Day 2 for analysis based on the Pielou's Evenness Index.|Day 2||||Pielou's Evenness Index||95% Confidence Interval|Mean
2530940|NCT03365934|Primary|Microbial Community Evenness - Day 1|Swabs will be collected on the back at Day 1 for analysis based on the Pielou's Evenness Index.|Day 1||||Pielou's Evenness Index||95% Confidence Interval|Mean
2530941|NCT03365934|Primary|Microbial Community Evenness - Baseline (Day 0)|Swabs will be collected on the back at Baseline (Day 0) for analysis based on the Pielou's Evenness Index.|Day 0||||Pielou's Evenness Index||95% Confidence Interval|Mean
2530942|NCT03365934|Primary|Microbial Community Diversity - Day 14|Swabs will be collected on the back at Day 14 for analysis based on the Shannon Index.|Day 14||||Shannon Diversity Index||95% Confidence Interval|Mean
2530943|NCT03365934|Primary|Microbial Community Diversity - Day 7|Swabs will be collected on the back at Day 7 for analysis based on the Shannon Index.|Day 7||||Shannon Diversity Index||95% Confidence Interval|Mean
2530944|NCT03365934|Primary|Microbial Community Diversity - Day 6|Swabs will be collected on the back at Day 6 for analysis based on the Shannon Index.|Day 6||||Shannon Diversity Index||95% Confidence Interval|Mean
2530945|NCT03365934|Primary|Microbial Community Diversity - Day 5|Swabs will be collected on the back at Day 5 for analysis based on the Shannon Index.|Day 5||||Shannon Diversity Index||95% Confidence Interval|Mean
2530946|NCT03365934|Primary|Microbial Community Diversity - Day 4|Swabs will be collected on the back at Day 4 for analysis based on the Shannon Index.|Day 4||||Shannon Diversity Index||95% Confidence Interval|Mean
2530947|NCT03365934|Primary|Microbial Community Diversity - Day 3|Swabs will be collected on the back at Day 3 for analysis based on the Shannon Index.|Day 3||||Shannon Diversity Index||95% Confidence Interval|Mean
2530948|NCT03365934|Primary|Microbial Community Diversity - Day 2|Swabs will be collected on the back at Day 2 for analysis based on the Shannon Index.|Day 2||||Shannon Diversity Index||95% Confidence Interval|Mean
2530949|NCT03365934|Primary|Microbial Community Diversity - Day 1|Swabs will be collected on the back at Day 1 for analysis based on the Shannon Index.|Day 1||||Shannon Diversity Index||95% Confidence Interval|Mean
2530956|NCT03365934|Primary|Microbial Community Richness - (Day 3)|Swabs will be collected on the back at Day 3 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.|Day 3||||Number of bacterial taxa||95% Confidence Interval|Mean
2530957|NCT03365934|Primary|Microbial Community Richness - (Day 2)|Swabs will be collected on the back at Day 2 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.|Day 2||||Number of bacterial taxa||95% Confidence Interval|Mean
2530958|NCT03365934|Primary|Microbial Community Richness - (Day 1)|Swabs will be collected on the back at Day 1 and analyzed to determine the total number of different bacteria Taxa (microorganisms) detected in the sample.|Day 1||||Number of bacterial taxa||95% Confidence Interval|Mean
2530959|NCT03365934|Primary|Microbial Community Richness - Baseline (Day 0)|Swabs will be collected on the back at Baseline (Day 0) and analyzed to determine the total number of different bacterial taxa (microorganisms) detected in the sample. There was no prespecified primary endpoint in the protocol.|Baseline (Day 0)||||Number of bacterial taxa||95% Confidence Interval|Mean
2530960|NCT03365778|Secondary|Measure Educational Effects of Selective Laser Trabeculoplasty (SLT) Among Ophthalmologists|To evaluate barriers for widespread adoption of selective laser trabeculoplasty (SLT) as first line treatment of high eye pressure, we assessed the beliefs and attitudes of ophthalmologists regarding SLT. An educational slide presentation and survey targeted physicians to increase awareness and consideration of SLT earlier in the glaucoma treatment paradigm. Number of respondents who currently offer laser treatment for newly diagnosed glaucoma patients.|30 minutes||||Participants|||Count of Participants
2530961|NCT03365778|Primary|Measure Educational Effects of Selective Laser Trabeculoplasty (SLT)|Attitudes were assessed in the Patient Educational Intervention group before and immediately following intervention to determine how receptive they were regarding Selective Laser Trabeculoplasty (SLT) as a therapy to lowering eye pressure as compared to the more common therapy of daily eye drops.|1 hour|Usual Care group not included since they did not receive education intervention.|||Participants|||Count of Participants
2530962|NCT03365778|Primary|Completion of Selective Laser Trabeculoplasty (SLT)|Percentage of patients who elect the Selective Laser Trabeculoplasty (SLT), as treatment for lowering eye pressure, compared between a group receiving SLT Educational Intervention and a Usual Care group. Follow-up eye examinations will be screened for a 6-month period to assess number of completed SLTs.|1 hour||||Participants|||Count of Participants
2530963|NCT03365011|Secondary|Patients' Global Impression of Change|Participant-reported perception of change in impact of tinnitus on quality of life since receiving each intervention|1 week post-intervention||||Participants|||Count of Participants
2530964|NCT03365011|Secondary|Change in Global Bothersome Scale (GBS) Score|"Change in participant-reported tinnitus bother after each intervention.~Global Bothersome Scale (GBS) measured participant's self-assessment of tinnitus bother on a 5-point scale ranging from Not bothered, 0 to Extremely bothered, 5.~A change of 0 indicates no change in tinnitus bother over time. A change of -1 indicates somewhat improved tinnitus bother, and a change of positive 1 indicates somewhat worsened tinnitus bother. A change of positive 2 indicates significantly worsened tinnitus bother."|Pre-intervention and 1 week post-intervention||||participants|||Number
2530965|NCT03365011|Primary|Change in Tinnitus Functional Index (TFI) Score|"Change of participant-reported tinnitus symptoms 1 week after each intervention.~The Tinnitus Functional Index (TFI) is a 25-question survey assessing tinnitus impact on quality of life. Participants were asked to rate on a scale from 0-10 the degree of unpleasantness, cognitive interference, sleep disturbance, auditory difficulties, interference with relaxation, and emotional distress associated with their tinnitus. Subscores are summed and scaled to a score of 0-100. A score less than 25 indicates mild problems due to tinnitus and little need for intervention, while a score between 25-50 indicates significant problems due to tinnitus with potential need for intervention.~A decrease in TFI score indicates decreased bother due to tinnitus over time, a better outcome. An increase in TFI score indicates increased bother due to tinnitus over time, a worse outcome."|Pre-intervention and 1 week post-intervention||||score on a scale||Standard Deviation|Mean
2530966|NCT03364608|Secondary|Peak Change From Baseline in FEV1|Peak Change from baseline in FEV1 (Forced expiratory volume in 1 second)|Over 6 hours post dose on Day 1|mITT Population|||Liters||95% Confidence Interval|Least Squares Mean
2530967|NCT03364608|Secondary|Change From Baseline in FEV1 AUC0-4|Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-4 (Area under the curve from 0 to 4 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose) normalized for length of follow up.|Over 4 hours post dose on Day 1|mITT Population|||Liters||95% Confidence Interval|Least Squares Mean
2530968|NCT03364608|Primary|Change From Baseline in FEV1 AUC0-6|Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-6 (Area under the curve from 0 to 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose) normalized for length of follow up.|Over 6 hours post dose on Day 1|mITT Population|||Liters||95% Confidence Interval|Least Squares Mean
2530969|NCT03364335|Secondary|Change in Inflammatory Markers|hs-C-Reactive Protein (CRP) levels was examined by standard blood chemistry.|Baseline to Day 168|Descriptive Statistics for Secondary Endpoint – hs-C-Reactive Protein Change from Baseline to day 168 (Per-Protocol Population).|||mg/L||Standard Deviation|Mean
2530970|NCT03364335|Secondary|Change in Systolic Blood Pressure|Change in Systolic blood pressure was assessed in patients from baseline to Day 168|Baseline, Day 168|ANCOVA Analysis for Secondary Endpoint – Change in Blood Pressure from Baseline to day 168 (Per-Protocol Population).|||mmHg||Standard Deviation|Mean
2530971|NCT03364335|Secondary|Change in Diastolic Blood Pressure|Diastolic blood pressure was measured by standard blood pressure monitor.|Baseline to Day 168|ANCOVA Analysis for Secondary Endpoint – Change in Blood Pressure from Baseline to day 168 (Per-Protocol Population)|||mmHg||Standard Deviation|Mean
2530972|NCT03364335|Secondary|Change in Hemoglobin A1c (HbA1c)|Change in Hemoglobin A1c was assessed in the subjects from baseline to day 168.|Baseline, Day 168|ANCOVA Analysis for Secondary Endpoint – Change in HbA1c from Baseline to day 168 (Per-Protocol Population).|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2530973|NCT03364335|Secondary|Change in Plasma Glucose|Change in plasma glucose was examined through standard fasting blood chemistry.|Baseline to Day 168|ANCOVA Analysis for Secondary Endpoint – Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).|||mg/dL||Standard Deviation|Mean
2530974|NCT03364335|Secondary|Change in Triglycerides|The change in triglycerides was evaluated by standard blood chemistry in subjects from Baseline to Day 168.|Baseline, Day 168|ANCOVA Analysis for Secondary Endpoint – Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).|||mg/dL||Standard Deviation|Mean
2530975|NCT03364335|Secondary|Change in LDL Cholesterol|Changes in LDL Cholesterol was measured by standard blood chemistry from baseline to day 168.|Baseline, 168 days|ANCOVA Analysis for Secondary Endpoint – Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).|||mg/dL||Standard Deviation|Mean
2530976|NCT03364335|Secondary|Change in HDL Cholesterol|Changes were measured in HDL cholesterol from Baseline to day 168 by standard blood chemistry.|Baseline, Day 168|ANCOVA Analysis for Secondary Endpoint – Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).|||mg/dL||Standard Deviation|Mean
2530977|NCT03364335|Secondary|Change in Total Cholesterol|Changes in total cholesterol was examined by standard blood chemistry.|Baseline to Day 168|ANCOVA Analysis for Secondary Endpoint – Change in Fasting Plasma Lipids from Baseline to day 168 (Per-Protocol Population).|||mg/dL||Standard Deviation|Mean
2530978|NCT03364335|Secondary|Change in Waist Circumference|The change in waist circumference by using a tape measure across the mid-section was evaluated in subjects from baseline to day 168.|Baseline to Day 168|ANCOVA Analysis for Secondary Endpoint – Change in Waist Circumference from Baseline (Per-Protocol Population).|||cm||Standard Deviation|Mean
2530979|NCT03364335|Secondary|Change in Percentage of Patients With ≥5% Body Weight Loss|The number of patients with ≥5% body weight loss in each group was assessed from baseline to day 168.|Baseline to Day 168|Analysis for Secondary Endpoint - Percentage of Subjects with ≥5% Relative Percentage Reduction from Baseline to day 168 in Body Weight by Treatment (Per-Protocol Population).|||Participants|||Count of Participants
2530980|NCT03364335|Secondary|Change in Absolute Body Weight|The change in absolute body weight from baseline to day 168 was evaluated.|Baseline to Day 168|ANCOVA Analysis for Secondary Endpoint – Change in Absolute Body Weight from Baseline to day 168 (Per-Protocol Population).|||kg||Standard Deviation|Mean
2530981|NCT03364335|Primary|Percentage Body Weight Change|The percentage body weight change from baseline to Day 168 was evaluated.|Baseline to Day 168|ANCOVA Analysis for Primary Endpoint – Percent Change in Body Weight from Baseline to Day 168 in per protocol population.|||percentage||Standard Deviation|Mean
2530982|NCT03363906|Primary|PK: Maximum Observed Drug Concentration (Cmax) of Dulaglutide|Pharmacokinetics was assessed in healthy participants to determine the maximum observed drug concentration (Cmax) of Dulaglutide.|Periods 1 and 2: Day 1 - 8 and Day 15: Predose, 24, 48, 72,96,120,144,168, and 336 hours post dose; Follow Up : Day 28|All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2530983|NCT03363906|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Dulaglutide|Pharmacokinetics was assessed in healthy participants to determine the area under the concentration time curve from 0 to infinity (AUC[0-∞]) of Dulaglutide.|Periods 1 and 2: Day 1 - 8 and Day 15: Predose, 24, 48, 72,96,120,144,168, and 336 hours post dose; Follow Up: Day 28|All randomized participants who received at least one dose of study drug and had evaluable PK data in the PFS or SDP arms.|||nanogram.hour/milliliter (ng.h/mL)||Geometric Coefficient of Variation|Geometric Mean
2530984|NCT03363633|Secondary|Ulcer Recurrence|Number of participants with ulcers that reopen after initial closure|12 months|The Responsible Party is no longer at University of Pittsburgh and has confirmed that the study data were lost. The only information available is the study was terminated for recruitment difficulty following enrollment of 12 participants overall, with no breakdown per study arm (source: final report submitted to the IRB).||||||
2530985|NCT03363633|Secondary|Compliance With Compression Therapy|Number of participants who use compression therapy|12 months|The Responsible Party is no longer at University of Pittsburgh and has confirmed that the study data were lost. The only information available is the study was terminated for recruitment difficulty following enrollment of 12 participants overall, with no breakdown per study arm (source: final report submitted to the IRB).||||||
2530986|NCT03363633|Secondary|Injection Complications|Number of participants experiencing venous thromboses from injections|12 months|The Responsible Party is no longer at University of Pittsburgh and has confirmed that the study data were lost. The only information available is the study was terminated for recruitment difficulty following enrollment of 12 participants overall, with no breakdown per study arm (source: final report submitted to the IRB).||||||
2530987|NCT03363633|Secondary|Venous Clinical Severity Score (VCSS)|The VCSS includes nine criteria of chronic venous disease, each graded from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe). Up to three points may be added for differences in background conservative therapy (compression and elevation). The scores are then added, with a maximum score of 30.|12 months|The Responsible Party is no longer at University of Pittsburgh and has confirmed that the study data were lost. The only information available is the study was terminated for recruitment difficulty following enrollment of 12 participants overall, with no breakdown per study arm (source: final report submitted to the IRB).||||||
2530988|NCT03363633|Primary|Ulcer Healing|Change in wound size, reported in square centimeters|12 months|The Responsible Party is no longer at University of Pittsburgh and has confirmed that the study data were lost. The only information available is the study was terminated for recruitment difficulty following enrollment of 12 participants overall, with no breakdown per study arm (source: final report submitted to the IRB).||||||
2530989|NCT03362944|Secondary|Active and Passive Music Therapy Post Intervention A-amylase|Post intervention stress hormone levels, as assessed through saliva swabs, will be compared between the Active and Passive intervention conditions.|Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame.||||Units per milliliter||Standard Deviation|Mean
2530990|NCT03362944|Secondary|Active and Passive Music Therapy Post Intervention Cortisol|Post intervention stress hormone levels, as assessed through saliva swabs, will be compared between the Active and Passive intervention conditions.|Interventions are administered 1 week apart, post intervention stress hormone levels will be assessed and compared on 1 week time frame.||||micrograms per deciliter||Standard Deviation|Mean
2539011|NCT03086265|Secondary|Total Ephedrine Dose (Vasoactive Drug)||Duration of surgery (average approximately 1 hour)|Participants who received ephedrine are included in the analysis.|||mg||Standard Deviation|Mean
2530991|NCT03362944|Secondary|Active and Passive Music Therapy Post Intervention HF and LF/HF Power Amplitude|Post intervention HRV recordings, assessed through two electrodes placed on the participant's right collarbone and left rib cage, will be compared between the Active and Passive intervention conditions.|Interventions are administered 1 week apart, post intervention recordings will be taken and compared on a 1 week time frame.||||Decibels||Standard Deviation|Mean
2530992|NCT03362944|Primary|Change From Baseline to Post Intervention Alpha-amylase (A-amylase)|Stress hormone levels correspond with HPA axis activity. This will be assessed using saliva swabs.|Before and after 40-minute intervention||||units per milliliter||Standard Deviation|Mean
2530993|NCT03362944|Primary|Change From Baseline to Post Intervention Cortisol|Stress hormone levels correspond with hypothalamic-pituitary-adrenal (HPA) axis activity. This will be assessed using saliva swabs.|Before and after 40-minute intervention||||Micrograms per deciliter||Standard Deviation|Mean
2530994|NCT03362944|Primary|Change From Baseline to Post Intervention High Frequency (HF) and Low Frequency Divided by High Frequency (LF/HF) Power Amplitude|Five minute heart-rate variability (HRV) recordings will be taken before and after each intervention session through two electrodes placed on the participant's right collarbone and left rib cage. The recordings will be analyzed for HF and LF/HF components, which correspond with sympathetic and parasympathetic autonomic nervous system (ANS) activity.|Before and after 40-minute intervention||||Decibels||Standard Deviation|Mean
2530995|NCT03362879|Secondary|Tapering Duration (Days) From Initial LCIG Administration of Each PD Medication|LCIG monotherapy means that the participant is not on any add-on PD medication/PD therapy at the respective time point (monotherapy 1). The number of days for tapering process is the number of days between maximum and minimum daily dose; participants with minimum (or maximum, respectively) daily dose not at the end of the tapering process were checked. A maximum duration of approximately 2 months of the tapering process was allowed (otherwise the tapering process was set to missing).|12 months|FAS|||days||Standard Deviation|Mean
2530996|NCT03362879|Secondary|Days From Initial LCIG Administration to the Initiation of LCIG Monotherapy|Time (in days) from LCIG initiation until monotherapy was calculated for those participants who were not on monotherapy (i.e., needed additional PD medication during LCIG infusion) at LCIG initiation, but reached monotherapy during the study. LCIG monotherapy means that the participant is not on any add-on PD medication/PD therapy at the respective time point (monotherapy 1) or that the participant is allowed to take an add-on PD medication/PD therapy at the respective time point but only in the evening after the LCIG infusion is completed (monotherapy 2).|12 months|FAS|||days||Standard Deviation|Mean
2530997|NCT03362879|Secondary|Time (Days) From Initial LCIG Administration to Substantial Dose Adjustment|Time for substantial change was determined as the time from LCIG initiation until the first substantial dose change in days 12 months after LCIG initiation. A substantial change was defined as a change of at least 20% compared to the LCIG dose at LCIG initiation.|12 months|FAS that includes only participants with substantial dose adjustments|||days||Standard Deviation|Mean
2530998|NCT03362879|Secondary|Time (Days) From Initial LCIG Administration to Substantial Dose Adjustments by Country|Time for substantial change was determined as the time from LCIG initiation until the first substantial dose change in days 12 months after LCIG initiation. A substantial change was defined as a change of at least 20% compared to the LCIG dose at LCIG initiation.|12 months|FAS that includes only participants with substantial dose adjustments by each country that had participants meeting these criteria|||days||Standard Deviation|Mean
2530999|NCT03362879|Secondary|Duration (Days) of LCIG Monotherapy 1 or Monotherapy 2|LCIG monotherapy means that the participant is not on any add-on PD medication/PD therapy at the respective time point (monotherapy 1) or that the participant is allowed to take an add-on PD medication/PD therapy at the respective time point but only in the evening after the LCIG infusion is completed (monotherapy 2). Duration of LCIG monotherapy was calculated for all participants who reached the respective monotherapy as time from LCIG initiation until LCIG is given as a monotherapy (separately for monotherapy 1 and monotherapy 2 definition).|12 months|FAS participants who reached the respective monotherapy (monotherapy 1 or monotherapy 2)|||days||Standard Deviation|Mean
2531000|NCT03362879|Secondary|Predictors for Monotherapy (Physician Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation)|"LCIG monotherapy 1 means that the participant is not on any add-on Parkinson's (PD) medication/PD therapy at the respective time point. The influence of predefined variables was evaluated using multivariable logistic regression models. The target variables were analyzed using two different sets of potential predictors: one set containing participant data and one set containing site and physician data.~Physician data in table shown as average frequency of routine visits includes average frequency of routine visits for advanced Parkinson's disease (APD) participants on device aided therapy ≥3x/years."|12 months|FAS|||odds ratio estimate||95% Confidence Interval|Number
2531001|NCT03362879|Secondary|Predictors for Monotherapy (Participant Data): Forward Selection for Monotherapy 1 (12 Months After LCIG Initiation)|LCIG monotherapy 1 means that the participant is not on any add-on Parkinson's (PD) medication/PD therapy at the respective time point. The influence of predefined variables was evaluated using multivariable logistic regression models. The target variables were analyzed using two different sets of potential predictors: one set containing participant data and one set containing site and physician data.|12 months|FAS|||odds ratio estimate||95% Confidence Interval|Number
2531002|NCT03362879|Secondary|Percentage of Physicians With Overall Preference for LCIG Monotherapy|The overall preference for treatment using LCIG as monotherapy compared with LCIG plus add-on PD medication, as stated by the physician.|12 months|Number of physicians stating LCIG as monotherapy is their overall treatment preference.|||percentage of physicians|||Number
2531003|NCT03362879|Secondary|HCRU: Caregiver Support by Number of Participants|"The HCRU questionnaire is used to assess healthcare resource utilization. Participants were asked about their occupational status (primary occupation), caregiver support (change in amount of caregiver help needed with daily activities/home care), and participant´s opinion on Parkinson's disease medication (number of pills in addition to LCIG the participant was willing to take each day).~Physicians were asked to report details regarding participant visits and hospital admissions in the 12 months prior to the study visit."|12 months|FAS|||participants|||Number
2531098|NCT03354663|Other Pre-specified|Average Power Delivered|This outcome is the average power delivered for a case.|During Procedure|The population includes only subjects with at least some radiofrequency energy delivered.|||Watts||Inter-Quartile Range|Median
2531004|NCT03362879|Secondary|Healthcare Resource Utilization (HCRU): Primary Occupation by Number of Participants|"The HCRU questionnaire is used to assess healthcare resource utilization. Participants were asked about their occupational status (primary occupation), caregiver support (change in amount of caregiver help needed with daily activities/home care), and participant´s opinion on Parkinson's disease medication (number of pills in addition to LCIG the participant was willing to take each day).~Physicians were asked to report details regarding participant visits and hospital admissions in the 12 months prior to the study visit."|12 months|FAS|||participants|||Number
2531005|NCT03362879|Secondary|Total Daily Dose (in Milliliters) of LCIG Infusion at 12 Months After LCIG Initiation|Physicians were asked to document the LCIG infusion details at 12 months after LCIG initiation, including the total daily dose. Total dose per day was calculated as morning dose + continuous dose x duration of infusion + extra dose. Abbreviations: ml = milliliters.|12 months|FAS and only participants with non-missing data.|||total LCIG dose per day (ml)||Standard Deviation|Mean
2531006|NCT03362879|Secondary|Percentage of Participants Starting Add-On PD Medication Within 12 Months of LCIG Monotherapy Initiation|LCIG monotherapy means that the participant is not on any add-on PD medication/PD therapy at the respective time point (monotherapy 1) or that the participant is allowed to take an add-on PD medication/PD therapy at the respective time point but only in the evening after the LCIG infusion is completed (monotherapy 2). PD medications were captured by time point and category from the initiation of LCIG therapy until the introduction of each add-on PD medication taken. Categories included levodopa, catechol-O-methyltransferase (COMT) inhibitors,dopamine agonist (excluding apomorphine), monoamine oxidase (MAO) inhibitor, n-methyl-d-aspartate receptor (NMDA) antagonist, apomorphine, anticholinergics, surgical therapy, or other. Participants may have initiated more than one PD medication or category.|12 months|FAS of participants starting add-on medication|||percentage of participants|||Number
2531007|NCT03362879|Primary|Percentage of Participants on Levodopa-Carbidopa Intestinal Gel (LCIG) Monotherapy From LCIG Initiation to 12 Months|The percentage of participants on LCIG monotherapy from immediately following LCIG initiation to 12 months. LCIG monotherapy means that the participant is not on any add-on Parkinson's (PD) medication/PD therapy at the respective time point (monotherapy 1) or that the participant is allowed to take an add-on PD medication/PD therapy at the respective time point but only in the evening after the LCIG infusion is completed (monotherapy 2).|12 months|Full analysis set (FAS): Participants that fulfilled all inclusion and none of the exclusion criteria.|||percentage of participants|||Number
2531008|NCT03361917|Secondary|Boston Bowel Preparation Score|"Boston Bowel Preparation Score for patients receiving standard colonoscopy compared to colonoscopy with endocuff vision.~The total score for the Boston Bowel Preparation Scale ranges from 0 to 9, with higher score indicating a better bowel preparation quality.~The quality of the bowel preparation is assessed by the attending gastroenterologist."|During the withdrawal portion of the colonoscopy procedure after cleaning of the colon||||Scores on a scale||Full Range|Median
2531009|NCT03361917|Secondary|Polyps Per Colonoscopy|Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision.|During the colonoscopy procedure||||Polyps per colonoscopy||Standard Error|Mean
2531010|NCT03361917|Secondary|Detection Rates|The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision.|During the colonoscopy procedure||||Percentage of Participants||95% Confidence Interval|Mean
2531011|NCT03361917|Secondary|Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision)|Total procedure time is the time from the initial insertion through the complete withdrawal of the scope|During the colonoscopy procedure||||Minutes||Standard Deviation|Mean
2531012|NCT03361917|Secondary|Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision)|Insertion time is the time it takes from the colonoscope first being inserted to when the furthest section of the colon (which is called the cecum) is reached.|During the insertion portion of the colonoscopy procedure||||Minutes||Standard Error|Mean
2531013|NCT03361917|Primary|Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision)|Inspection time is time spent actually examining the colon. This was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. It was measured during colonoscopy by a study assistant using a stopwatch.|During the withdrawal portion of the colonoscopy procedure||||Minutes||Standard Error|Mean
2531014|NCT03361865|Secondary|Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Discontinuing Study Treatment Due to AE|AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.|Up to approximately 9 months at data cut-off 15-AUG-2018|All Participants as Treated (APaT) population consisted of all randomized participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2531015|NCT03361865|Secondary|Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo as Measured by Number of Participants Experiencing Adverse Events (AEs)|AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.|Up to approximately 9 months at data cut-off 15-AUG-2018|All Participants as Treated (APaT) population consisted of all randomized participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2531016|NCT03361865|Primary|Objective Response Rate (ORR) With Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo|"ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.~Responses are based on Investigator assessments per RECIST 1.1 without confirmation using all scans up to the cutoff date."|Week 9|The Intention-to-Treat (ITT) population consisted of all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2531017|NCT03361176|Secondary|Subject Satisfaction Rating Scale|Satisfaction will be compared between treatment groups at each post-treatment time point through Day 180 using a 7-point satisfaction scale rating from extremely dissatisfied (score of 0) to extremely satisfied (score of 6).|Post-treatment to Day 180||||Participants|||Count of Participants
2539012|NCT03086265|Secondary|Total Phenylephrine Dose (Vasoactive Drug)||Duration of surgery (average approximately 1 hour)|Participants who received phenylephrine are included in the analysis.|||mg||Standard Deviation|Mean
2531018|NCT03361176|Secondary|Change in Clinician-Reported Submental Laxity Rating Scale|Laxity will be compared between treatment groups at each post-treatment time point through Day 90 using a 5-Point Clinician Evaluation of Side Effects Scale ranging from None (score of 0) to Severe (score of 4).|90 days from baseline||||Participants|||Count of Participants
2531019|NCT03361176|Primary|Change in Clinician-Reported Submental Fat Rating Scale|Change in efficacy will be measured from Baseline to 90 days post final treatment using a 5-point Clinician-Reported Submental Fat Rating Scale ranging from Absent (score of 0) to Extreme submental convexity (score of 4)|90 Days from Baseline||||Participants|||Count of Participants
2531020|NCT03360903|Secondary|Heart Rate|This measurement is made in order to determine whether caffeine alters heart rate in a deleterious manner.|Up to 120 minutes after terminating anesthesia.|Due to technical problems during the study, data was not collected and analyzed.||||||
2531021|NCT03360903|Secondary|Mean Arterial Blood Pressure|This measurement is made in order to determine whether caffeine alters blood pressure in a deleterious manner.|Up to 120 minutes after terminating anesthesia.|Due to technical problems during the study, data was not collected and analyzed.||||||
2531022|NCT03360903|Secondary|Bispectral Index|A bispectral index (BIS) measurement system is employed to measure depth of anesthesia. In particular, we wish to determine whether BIS exhibits more rapid recovery after caffeine compared to control.|Up to 120 minutes after terminating anesthesia.|Due to technical problems during the study, data was not collected and analyzed.||||||
2531023|NCT03360903|Secondary|Cognitive Test3 - Divided Attention Task|Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. The test is first applied at 15 minutes following anesthesia, if the subject is awake and then repeated every 15 minutes. In the Divided Attention Task (DAT), participants are asked to fly an airplane over the center of a winding road with a joystick and simultaneously press a button whenever targets randomly flash on the screen. The computer program tracks the root mean squared (RMS) deviation of the plane from the center of the road and the latency for pressing the trigger when the target appears.|Up to 120 minutes after terminating anesthesia.|Due to technical problems during the study, data was not collected and analyzed.||||||
2531024|NCT03360903|Secondary|Cognitive Test2 - Sternberg Test of Memory|Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. The test will be applied at 15 minutes following anesthesia, if the subject is awake and then repeated every 15 minutes. In the Sternberg Test of Memory (STM) participants are asked to memorize a string of numbers. Afterwards, a computer will flash a series of random numbers on the screen and the participant is asked whether the number on the computer screen are part of the earlier string or not. In three rounds, participants are given a string of 2, then 4, then 6 numbers. The latency until the subject answers the question is also monitored.|Up to 120 minutes after terminating anesthesia.|Due to technical problems during the study, data was not collected and analyzed.||||||
2531025|NCT03360903|Secondary|Cognitive Test1 - Visual Analog Scale|"Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. Fifteen minutes after terminating anesthesia each subject will be asked to complete a series of psychomotor tests, if they are able. Otherwise the testing started at 30 minutes. The tests will be repeated every 15 minutes. The first test, a visual analog scale (VAS) test consisted of two 100-mm lines, each labelled with of feel good or feel bad displayed on a computer screen. Test subjects will be asked to rate how they currently felt by placing a cursor on each of the line (0=not at all, 100=extremely). The test will be repeated every 15 minutes."|Up to 120 minutes after terminating anesthesia.|Due to technical problems during the study, data was not collected and analyzed.||||||
2531026|NCT03360903|Primary|Waking Time - Time Between Terminating Anesthesia and Subject Opening Eyes.|"The goal of the study is to determine whether caffeine speeds emergence from anesthesia. The time between terminating delivery of anesthetic and the subject opening their eyes will be measured. The time to emerge from anesthesia will be defined as the time between terminating the anesthesia and the test subject opening their eyes."|15 minutes|Due to technical problems during the study, data was not collected and analyzed.||||||
2531027|NCT03360071|Secondary|Safety Assessment|Safety and adverse events (AES) will be followed. We will measure and report systemic reactions.|continuous review of safety up to 14 week||||Participants|||Count of Participants
2531028|NCT03360071|Secondary|Rescue Medication Use|Use of epinephrine during intervention for a total of 8 weeks through followup and study completion (4 more weeks). Thus total number of times epinephrine is required per patient during entire 12 week period.|Duration of intervention plus followup (12 weeks)||||Participants|||Count of Participants
2531029|NCT03360071|Primary|Mini RQLQ|mini-RQLQ (mini-Rhinoconjunctivitis Quality of Life Questionnaire) is to measure a the level of severity of a set of symptoms of functional impairments due to rhinoconjunctivitis from baseline. 14 questions each range 0-6 (6 is most severe). Total range 0-84 (higher value is more severe symptoms).|Change from baseline at 10 weeks||||score on a scale||Standard Deviation|Mean
2531030|NCT03360071|Primary|Daily Combined Score (DCS)|Change in baseline. TNSS (Total Nasal Symptoms Score) + medication rescue score. TNSS is a scale of 0-12 with 12 being severe. Medication score is also 0-12 with 12 being highest use of medications. Thus DCS ranges from 0-24 (severe).|Change from baseline at 10 weeks||||DCS (daily combined score)||Standard Deviation|Mean
2531031|NCT03359629|Primary|Percentage of Measurements With < 15% Error|Difference in measurements of blood glucose level obtained using Spectrophon glucometry monitor and commercially available glucose analyser YSI 2300|1-3 hours||||Percentage of measures with error <15%|||Number
2531032|NCT03358472|Secondary|Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Discontinuing Study Treatment Due to AEs|"AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.~Data reported from start of study to data cutoff 17 Jan 2019, up to 14 months."|Up to 14 months|All Participants as Treated (APaT) population consisted of all randomized participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2539013|NCT03086265|Secondary|Total Remifentanil Dose (Anesthetic)||Duration of surgery (average approximately 1 hour)||||µg||Standard Deviation|Mean
2531033|NCT03358472|Secondary|Safety and Tolerability of Pembrolizumab + Epacadostat Versus Pembrolizumab Versus the EXTREME Regimen as Measured by Number of Participants Experiencing Adverse Events (AEs)|"AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.~Data reported from start of study to data cutoff 17 Jan 2019, up to 14 months."|Up to 14 months|All Participants as Treated (APaT) population consisted of all randomized participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2531034|NCT03358472|Primary|Objective Response Rate (ORR) of Pembrolizumab + Epacadostat, Pembrolizumab Monotherapy and the EXTREME Regimen|"ORR was defined as the percentage of participants who had a complete response (CR), disappearance of all target lesions or partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions per RECIST v1.1 by investigator determination.~Responses are based on investigator assessments per RECIST 1.1 without confirmation using all available scans."|Minimum Week 9|"The Intention-to-Treat (ITT) population consisted of all randomized participants.~The ORR was based on all available imaging assessments after the last participant completed the Week 9 imaging assessment by investigator determination."|||percentage of participants||95% Confidence Interval|Number
2531035|NCT03358355|Other Pre-specified|Number of Participants Who Experienced Serious Adverse Events|Serious adverse events|Within 24 hours after subcutaneous injection.|Data originate from participants that received the injection and of which had data available|||Participants|||Count of Participants
2531036|NCT03358355|Other Pre-specified|Number of Participants Who Experienced Adverse Events|Adverse events|Within 24 hours after subcutaneous injection.|Data originate from participants that received the injection and of which had data available|||Participants|||Count of Participants
2531037|NCT03358355|Secondary|Brachial Artery Flow-mediated Dilation (FMD)|Brachial artery flow-mediated dilation in response to hyperemia. The outcome is reporting the MAX Relative FMD 60/90 (%), which is calculated as the highest FMD between the RH60 and RH90 results, as a percent.|Baseline, 6-8 hours after baseline, 24 hours after baseline.|Data originate from participants that received the injection and of which had data available|||ratio||Inter-Quartile Range|Median
2531038|NCT03358355|Primary|Levels of Unacylated Ghrelin|Levels of unacylated ghrelin are measured before and after every injection|Baseline and at scheduled intervals up to 24 hours after baseline|Data originate from participants that received the injection and of which had data available|||pg/ml||Standard Deviation|Mean
2531039|NCT03358329|Secondary|Nasal Obstruction/Congestion Score|Determined on a scale of 0 (no symptoms) to 3 (severe symptoms) based on the subject's recollection of symptoms over the past week using a reflective paper questionnaire. Change from baseline to 90 days and to 180 days is calculated as the value at 90/180 days minus the value at baseline. Negative values for change from baseline to follow-up indicate reduction (improvement) in nasal obstruction/congestion.|Baseline, 90 days, 180 days|Analysis population includes subjects with available data at that time point.|||units on a scale||Standard Deviation|Mean
2531040|NCT03358329|Secondary|SNOT-22 Total Score|Sino-Nasal Outcomes Test (SNOT-22) is a validated disease-specific symptom-scoring instrument consisting of 22 questions, each scored on a 6-point scale of 0 (no problem) to 5 (probably as bad as it can be) based on the subject's recollection of symptoms over the past 2 weeks. The total score ranges from 0 to 110, with a higher score reflecting greater symptom burden. Change from baseline to 90 days and to 180 days is calculated as the value at 90/180 days minus the value from baseline. Negative values for change from baseline indicate reduction (improvement) in sino-nasal symptoms.|Baseline, 90 days, 180 days|Analysis population includes subjects with available data at that time point.|||score on a scale||Standard Deviation|Mean
2531041|NCT03358329|Primary|Number of Participants With Implant-Related Serious Adverse Events|Evaluated via tabulation of implant-related serious adverse events (SAE) reported by subjects between consent and Day 365.|365 days||||Participants|||Count of Participants
2531042|NCT03357952|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) in Part 2|An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are adverse events (AEs) which will occur up to 2 years that were absent before treatment or that worsened relative to pre-treatment state.|Up to 2 years|Safety analysis set included all participants who have received at least 1 dose of study agent in Part 2 of the study.|||Participants|||Count of Participants
2531043|NCT03357952|Primary|Number of Participants With Dose Limiting Toxicity in Safety run-in Phase (Part 1)|Dose limiting toxicity defined as an adverse event or adverse drug reaction experienced by the participants during observation of 28 days (Part 1) of treatment Cycle 1.|Cycle 1 (28 days)|Safety analysis set included all participants who have received at least 1 dose of study agent (JNJ-63723283 or daratumumab, partial or complete) in safety run-in phase.|||Participants|||Count of Participants
2531044|NCT03357952|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAE) in Safety run-in Phase (Part 1)|An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are adverse events (AEs) which will occur up to 2 years that were absent before treatment or that worsened relative to pre-treatment state.|Up to 2 years|Safety analysis set included all participants who have received at least 1 dose of study agent (JNJ-63723283 or daratumumab, partial or complete) in safety run-in phase of the study.|||Participants|||Count of Participants
2531045|NCT03357471|Secondary|Incidence of Adverse Device Events (ADEs) During the Study|"An Adverse Device Event (ADE) was an AE related to the use of an investigational device. An ADE must have met 1 or more of the following criteria:~Adverse event that resulted from insufficiencies or inadequacies in the Instructions for Use (IFU), the deployment, the implantation, the installation, the operation, or any malfunction of the investigational medical device~Adverse event that was a result of an error or intentional misuse."|During the study (from Week 0 up to Week 5 +/-3 Days)|The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device).|||percentage of participants|||Number
2531158|NCT03351231|Secondary|Percent Urinary Recovery Over 24 Hours (%UR24)|The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0|Approximately 2 years|Study terminated, data not reported due to privacy reasons||||||
2531046|NCT03357471|Secondary|Incidence of Adverse Events (AEs) During the Study|An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational medicinal product (IMP), whether or not related to the medicinal (investigational) product.|During the study (from Week 0 up to Week 5 +/-3 Days)|The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device).|||percentage of participants|||Number
2531047|NCT03357471|Secondary|Mean Change From Baseline in Body Temperature|Body Temperature was measured in Grad Celsius (°C).|From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)|The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device). The mean was based on the number of SS subjects that participated in Visit 2 and received at least 1 dose of CZP.|||Temperature (C)||Standard Deviation|Mean
2531048|NCT03357471|Secondary|Mean Change From Baseline in Respiratory Rate|Respiratory Rate was measured in breaths per minute (breaths/min).|From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)|The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device). The mean was based on the number of SS subjects that participated in Visit 2 and received at least 1 dose of CZP.|||breaths/min||Standard Deviation|Mean
2531049|NCT03357471|Secondary|Mean Change From Baseline in Pulse Rate|Pulse Rate was measured in beats per minute (beats/min).|From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)|The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device). The mean was based on the number of SS subjects that participated in Visit 2 and received at least 1 dose of CZP.|||beats/min||Standard Deviation|Mean
2531050|NCT03357471|Secondary|Mean Change From Baseline in Diastolic Blood Pressure|Blood pressure was measured in millimetre of mercury (mmHg).|From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)|The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device). The mean was based on the number of SS subjects that participated in Visit 2 and received at least 1 dose of CZP.|||mmHg||Standard Deviation|Mean
2531051|NCT03357471|Secondary|Mean Change From Baseline in Systolic Blood Pressure|Blood pressure was measured in millimetre of mercury (mmHg).|From Week 0 to Visit 2 (Week 2 for Q2W; Week 4 for Q4W)|The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device). The mean was based on the number of SS subjects that participated in Visit 2 and received at least 1 dose of CZP.|||mmHg||Standard Deviation|Mean
2531052|NCT03357471|Secondary|Percentage of Used Certolizumab Pegol (CZP)-Cassettes Identified as Having Structural Integrity Issues Based on Visual Examination|CZP-cassettes identified as having structural integrity issues meant CZP-cassettes with clear evidence of damage/compromised structural integrity, not superficial cosmetic imperfections.|During the study (from Week 0 up to Week 4)|The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device). Percentages were based on the number of cassettes evaluated.|||percentage of cassettes|CZP - cassettes|90% Confidence Interval|Number
2531053|NCT03357471|Secondary|Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 1|"Safe and effective self-injection was evaluated by the healthcare provider and is defined as:~Dose Delivery: Subject self-injected the complete dose of Certolizumab Pegol (CZP) as confirmed by a visual inspection of the CZP-cassette(s) which shows the pre-filled syringe container to be empty AND~No Adverse Events related to use of the e-Device (Adverse Device Effects) that would preclude continued use of the e-Device for self-injection.~For subjects on the Q4W (every 4 weeks) dosing regimen who would self-inject twice (2×200 mg CZP) at each visit, each injection was evaluated for safety and effectiveness using the above criteria. The primary endpoint of safe and effective self-injection for subjects on the Q4W dosing regimen was met only if both self-injections were determined to be safe and effective."|Visit 1 (Week 0)|The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device). Percentages were based on the number of SS subjects that participated in Visit 1 and received at least 1 dose of CZP.|||percentage of subjects||90% Confidence Interval|Number
2531054|NCT03357471|Primary|Percentage of Subjects Able to Self-administer Safe and Effective Injections Using the e-Device at Visit 2|"Safe and effective self-injection was evaluated by the healthcare provider and is defined as:~Dose Delivery: Subject self-injected the complete dose of Certolizumab Pegol (CZP) as confirmed by a visual inspection of the CZP-cassette(s) which shows the pre-filled syringe container to be empty AND~No Adverse Events related to use of the e-Device (Adverse Device Effects) that would preclude continued use of the e-Device for self-injection.~For subjects on the Q4W (every 4 weeks) dosing regimen who would self-inject twice (2×200 mg CZP) at each visit, each injection was evaluated for safety and effectiveness using the above criteria. The primary endpoint of safe and effective self-injection for subjects on the Q4W dosing regimen was met only if both self-injections were determined to be safe and effective."|Visit 2 (Week 2 for Q2W; Week 4 for Q4W)|The Safety Set (SS) consisted of all subjects of the study who had received at least 1 dose of CZP during the study (e-Device). Percentages were based on the number of SS subjects that participated in Visit 2 and received at least 1 dose of CZP.|||percentage of subjects||90% Confidence Interval|Number
2531055|NCT03356977|Primary|Number of Participants With Clinically Significant Laboratory Parameters Meeting Pre-defined Criteria|Criteria: hematology: hemoglobin, hematocrit, erythrocytes < 0.8*lower limit of normal (LLN), platelets <0.5*LLN >1.75*upper limit of normal (ULN), leukocytes <0.6* LLN >1.5* ULN, lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes <0.8* LLN >1.2* ULN, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes monocytes monocytes/leukocytes >1.2*ULN. Clinical chemistry: bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN, protein, albumin <0.8* LLN >1.2* ULN, blood urea nitrogen, creatinine >1.3* ULN, sodium <0.95*LLN >1.05*ULN, potassium, chloride, bicarbonate <0.9* LLN >1.1* ULN, glucose <0.6*LLN >1.5*ULN.|Baseline (Day 1) up to Day 29 (end of treatment)|"Safety analysis set included any participant who received at least 1 dose of investigational product. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2539014|NCT03086265|Secondary|Total Propofol Dose (Anesthetic)||Duration of surgery (average approximately 1 hour)||||mg||Standard Deviation|Mean
2531056|NCT03356977|Primary|Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values Meeting Pre-defined Criteria|ECG of participants was measured in terms of millisecond (msec). ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Fridericia's formula (QTcF). ECG values meeting pre-defined criteria were 1) PR interval: greater than equal to (>=) 25 percent (%) increase when baseline greater than (>)200 milliseconds (msec); or increase >=50% when baseline less than or equal to (<=200) msec; 2) QRS interval: >=25% increase when baseline >100 msec; >=50% increase when baseline <= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) > 30 msec. IFB stands for increase from baseline.|Baseline (Day 1) up to Day 29 (end of treatment)|"Safety analysis set included any participant who received at least 1 dose of investigational product. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2531057|NCT03356977|Primary|Number of Participants With Clinically Significant Body Temperature Values Meeting Pre-defined Criteria|Body temperature of participants was measured in degree Celsius. The normal body temperature value was >= 39 degree Celsius.|Baseline (Day 1) up to Day 29 (end of treatment)|Safety analysis set included any participant who received at least 1 dose of investigational product.|||Participants|||Count of Participants
2531058|NCT03356977|Primary|Number of Participants With Clinically Significant Respiratory Rate Values Meeting Pre-defined Criteria|Respiratory rate was measured in terms of number of breaths per minute. The pre-defined criteria of measuring the respiratory rate of participants was < 22 breaths per min and > 53 breaths per min.|Baseline (Day 1) up to Day 29 (end of treatment)|Safety analysis set included any participant who received at least 1 dose of investigational product.|||Participants|||Count of Participants
2531059|NCT03356977|Primary|Number of Participants With Clinically Significant Pulse Rate Values Meeting Pre-defined Criteria|Pulse rate of participants was measured in terms of beats per minute (bpm). The pre-defined criteria of measuring the pulse rate of participants was <90 bpm and >180 bpm.|Baseline (Day 1) up to Day 29 (end of treatment)|Safety analysis set included any participant who received at least 1 dose of investigational product.|||Participants|||Count of Participants
2531060|NCT03356977|Primary|Number of Participants With Clinically Significant Blood Pressure Values Meeting Pre-defined Criteria|Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) of participants was measured in terms of millimeters of mercury (mmHg). The clinically significant pre-defined criteria were, SBP: change of greater than equal to (>=) 30 mmHg increase from baseline (IFB) and SBP change of >= 30 mmHg decrease from baseline (DFB); DBP: change of >=20 mmHg IFB and DBP change of >=20 mmHg DFB.|Baseline (Day 1) up to Day 29 (end of treatment)|"Safety analysis set included any participant who received at least 1 dose of investigational product. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies participants evaluable for specific rows."|||Participants|||Count of Participants
2531061|NCT03356977|Primary|Number of Participants With Clinically Significant Weight Values Meeting Pre-defined Criteria|Weight of participants was measured in terms of kilogram (kg). The pre-defined criteria of measuring the weight of participants was less than equal to (<=) 4.5 kg and >15 kg.|Baseline (Day 1) up to Day 29 (end of treatment)|"Safety analysis set included any participant who received at least 1 dose of investigational product. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2531062|NCT03356977|Primary|Number of Participants With Clinically Significant Height Values Meeting Pre-defined Criteria|Height of participants was measured in terms of centimeter (cm). The pre-defined criteria for measuring the height was less than (<) 55 cm and greater than (>) 92.5 cm.|Baseline (Day 1) up to Day 29 (end of treatment)|"Safety analysis set included any participant who received at least 1 dose of investigational product. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2531063|NCT03356977|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Site Reactions|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Site reactions are reactions which occurred in participants at the site of application of investigational product.|Baseline (Day 1) up to at least 28 days after last dose of investigational product (up to 60 days)|Safety analysis set included any participant who received at least 1 dose of investigational product.|||Participants|||Count of Participants
2531064|NCT03355820|Secondary|Concentration of Antibodies Against HPV-18 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies|"Anti-HPV-18 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL.~Anti-HPV-18 antibody concentrations at Day 1 in the present study were compared with the anti-HPV-18 antibody concentrations obtained as per the analysis performed on the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6.~Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure.~Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 40)."|At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study|The analysis was performed on the PPS for analysis of immunogenicity in HPV-093 study and on the ATP cohort for analysis of immunogenicity which included all evaluable subjects in the immunogenicity subset of HPV-039 study. For Year 6 data in HPV-039 study, please refer to the Outcome measure 40 in NCT00779766 record.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2531074|NCT03354754|Primary|Plasma Pharmacokinetics (PK) of LYS228: The Terminal Elimination Half-life (T1/2)|Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5|Day 5|PK analysis for the 2 patients enrolled that received LYS228 was not conducted as per protocol the first analysis required 8 patients||||||
2531065|NCT03355820|Secondary|Concentration of Antibodies Against HPV-16 at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies|"Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL.~Anti-HPV-16 antibody concentrations at Day 1 in the present study were compared with the anti-HPV-16 antibody concentrations obtained as per the analysis performed on the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6.~Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure.~Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 40)."|At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study|The analysis was performed on the PPS for analysis of immunogenicity in HPV-093 study and on the ATP cohort for analysis of immunogenicity which included all evaluable subjects in the immunogenicity subset of HPV-039 study. For Year 6 data in HPV-039 study, please refer to the Outcome measure 40 in NCT00779766 record.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2531066|NCT03355820|Secondary|Number of Seropositive Subjects for Anti-HPV-18 Antibodies at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies|"A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 18 EL.U/mL.~The number of seropositive subjects at Day 1 in the present study was compared with the number of seropositive subjects from the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6.~Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure.~Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 39)."|At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study|The analysis was performed on the PPS for analysis of immunogenicity in HPV-093 study and on the ATP cohort for analysis of immunogenicity which included all evaluable subjects in the immunogenicity subset of HPV-039 study. For Year 6 data in HPV-039 study, please refer to the Outcome measure 39 in NCT00779766 record.|||Participants|||Count of Participants
2531067|NCT03355820|Secondary|Number of Seropositive Subjects for Anti-HPV-16 Antibodies at Day 1 in HPV-093 (NCT03355820) and at Year 6 in HPV-039 (NCT00779766) Studies|"A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 19 EL.U/mL.~The number of seropositive subjects at Day 1 in the present study was compared with the number of seropositive subjects from the immunogenicity subset in HPV-039 (NCT00779766) study at Year 6.~Data corresponding to Day 1 time point of the present study can also be found in the primary outcome measure.~Data at Year 6 in subjects from the immunogenicity subset in HPV-039 study can be found in the respective NCT record NCT00779766 (please refer to Outcome measure 38)."|At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study) and at Year 6 in HPV-039 (NCT00779766) study|The analysis was performed on the PPS for analysis of immunogenicity in HPV-093 study and on the ATP cohort for analysis of immunogenicity which included all evaluable subjects in the immunogenicity subset of HPV-039 study. For Year 6 data in HPV-039 study, please refer to the Outcome measure 38 in NCT00779766 record.|||Participants|||Count of Participants
2531068|NCT03355820|Primary|Anti-HPV-18 Antibody Concentrations at Day 1 in HPV-093 (NCT03355820) Study|Anti-HPV-18 antibody concentrations are presented as GMCs, expressed in EL.U/mL.|At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)|The analysis was performed on the Per-Protocol Set (PPS) for analysis of immunogenicity, which included all evaluable subjects who were included in the according to protocol (ATP) immunogenicity analysis of the primary vaccination study HPV-058 (NCT00996125), and with serology results available at this blood sampling time point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2531069|NCT03355820|Primary|Anti-HPV-16 Antibody Concentrations at Day 1 in HPV-093 (NCT03355820) Study|Anti-HPV-16 antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in EL.U/mL.|At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)|The analysis was performed on the Per-Protocol Set (PPS) for analysis of immunogenicity, which included all evaluable subjects who were included in the according to protocol (ATP) immunogenicity analysis of the primary vaccination study HPV-058 (NCT00996125), and with serology results available at this blood sampling time point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2531070|NCT03355820|Primary|Number of Seropositive Subjects for Anti-HPV-18 Antibodies at Day 1 in HPV-093 (NCT03355820) Study|A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 18 EL.U/mL.|At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)|The analysis was performed on the Per-Protocol Set (PPS) for analysis of immunogenicity, which included all evaluable subjects who were included in the according to protocol (ATP) immunogenicity analysis of the primary vaccination study HPV-058 (NCT00996125), and with serology results available at this blood sampling time point.|||Participants|||Count of Participants
2531071|NCT03355820|Primary|Number of Seropositive Subjects for Anti-HPV-16 Antibodies at Day 1 in HPV-093 (NCT03355820) Study|A seropositive subject is defined as a subject whose antibody concentration is equal to or above the cut-off value of 19 Enzyme Linked Immunosorbent Assay units per milliliter (EL.U/mL).|At Day 1 in HPV-093 (NCT03355820) study (i.e. 7 to 8 years after completion of the vaccination schedule in HPV-058 [NCT00996125] study)|The analysis was performed on the Per-Protocol Set (PPS) for analysis of immunogenicity, which included all evaluable subjects who were included in the according to protocol (ATP) immunogenicity analysis of the primary vaccination study HPV-058 (NCT00996125), and with serology results available at this blood sampling time point.|||Participants|||Count of Participants
2531072|NCT03354754|Secondary|Microbiological Response at Day 28|Microbiologic success at 28 days after randomization determined by microbial growth in culture from the intra-abdominal focus of infection when available or presumed eradication based on clinical success|Day 28|All patients with a microbiological response assessment|||Participants|||Count of Participants
2531073|NCT03354754|Secondary|Number of Patients With Adverse Events|Number of patients with at least one Adverse Event|Daily|All patients|||Participants|||Count of Participants
2547118|NCT02912195|Secondary|Pain Relief at 10 Minutes Compared to Baseline.|Pain NRS at 0 minutes minus pain NRS at 10 minutes|At 10 minutes||||units on a scale||95% Confidence Interval|Mean
2531075|NCT03354754|Primary|Plasma Pharmacokinetics (PK) of LYS228: The Volume of Distribution at Steady State Following Intravenous Administration (Vss)|Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5|Day 5|PK analysis for the 2 patients enrolled that received LYS228 was not conducted as per protocol the first analysis required 8 patients||||||
2531076|NCT03354754|Primary|Plasma Pharmacokinetics (PK) of LYS228: The Systemic (or Total Body) Clearance From Plasma Following Intravenous Administration (CL)|Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5|Day 5|PK analysis for the 2 patients enrolled that received LYS228 was not conducted as per protocol the first analysis required 8 patients||||||
2531077|NCT03354754|Primary|Plasma Pharmacokinetics (PK) of LYS228: The Time to Reach the Maximum Concentration After Drug Administration (Tmax)|Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5|Day 5|PK analysis for the 2 patients enrolled that received LYS228 was not conducted as per protocol the first analysis required 8 patients||||||
2531078|NCT03354754|Primary|Plasma Pharmacokinetics (PK) of LYS228: The Observed Maximum Plasma Concentration Following Drug Administration (Cmax)|Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5|Day 5|PK analysis for the 2 patients enrolled that received LYS228 was not conducted as per protocol the first analysis required 8 patients||||||
2531079|NCT03354754|Primary|Plasma Pharmacokinetics (PK) of LYS228: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)|Calculated based on LYS228 concentration in blood at different time points following drug administration on Day 5|Day 5|PK analysis for the 2 patients enrolled that received LYS228 was not conducted as per protocol the first analysis required 8 patients.||||||
2531080|NCT03354754|Primary|Clinical Success at Day 28|Clinical success is defined as resolution, or substantial improvement (i.e. reduction of severity of all baseline signs and symptoms and worsening of none) of all or most baseline signs and symptoms of cIAI infection without the need for additional antibiotic therapy other than any oral antibiotics given to complete treatment at home following discontinuation of Study Drug and no drainage or surgical reintervention required 96 hours after the start of Study Drug.|Day 28|All patients|||Participants|||Count of Participants
2531081|NCT03354663|Other Pre-specified|Number of Participants Using AutoMark|This outcome is the number of cases using AutoMark.|0 days|The population includes only subjects with at least some radiofrequency energy delivered.|||Participants|||Count of Participants
2531082|NCT03354663|Other Pre-specified|Radiofrequency (RF) Application Time|This outcome is the total RF application time for a case.|0 days|The population includes only subjects with at least some radiofrequency energy delivered.|||minutes||Inter-Quartile Range|Median
2531083|NCT03354663|Other Pre-specified|Fluoroscopy Time|This outcome is the total fluoroscopy time for a case.|0 days|The population includes only subjects with at least some radiofrequency energy delivered.|||minutes||Inter-Quartile Range|Median
2531084|NCT03354663|Other Pre-specified|Ablation Time - First to Last Ablation|This outcome is the total ablation time for a case. This is the time from first to last ablation.|0 Days|The population includes only subjects with at least some radiofrequency energy delivered.|||minutes||Inter-Quartile Range|Median
2531085|NCT03354663|Other Pre-specified|Total Procedure Time|This outcome is the total procedure time for a case.|0 days|The population includes only subjects with at least some radiofrequency energy delivered.|||minutes||Inter-Quartile Range|Median
2531086|NCT03354663|Other Pre-specified|Contact Force During Procedure|This outcome is the average contact force for a case.|0 days|The population includes only subjects with at least some radiofrequency energy delivered.|||grams||Standard Deviation|Mean
2531087|NCT03354663|Other Pre-specified|Number of Participants With Recommended Irrigation Flow Rate Used During Procedure|This outcome is whether or not the recommended irrigation flow rate was used for a case.|0 days|The population includes only subjects with at least some radiofrequency energy delivered.|||Participants|||Count of Participants
2531088|NCT03354663|Other Pre-specified|Average Catheter Temperature|This outcome is the average temperature (by lesion) for a case.|0 days|The population includes only subjects with at least some radiofrequency energy delivered.|||degrees celsius||Inter-Quartile Range|Median
2531089|NCT03354663|Other Pre-specified|Force Time Integral (FTI) and Lesion Index (LSI)|FTI and LSI will be derived from the available EnSite Precision data. Descriptive statistics will be generated for both variables.|0 days||2020-06-30|06/2020||||
2531090|NCT03354663|Other Pre-specified|Health Care Utilization|Cardiovascular-related health care utilization through 12 months post index ablation|1 year||2020-06-30|06/2020||||
2531091|NCT03354663|Other Pre-specified|Changes in AFEQT Scores|Changes in AFEQT scores from baseline to follow up at 3, 6, and 12 months|1 year||2020-06-30|06/2020||||
2531092|NCT03354663|Other Pre-specified|Changes in EQ-5D-5L Scores|Changes in EQ-5D-5L scores from baseline to follow up at 3, 6, and 12 months|1 year||2020-06-30|06/2020||||
2531093|NCT03354663|Other Pre-specified|One-year Drug-free Success From AF|One-year drug-free success defined as freedom from any AF/AFL/AT lasting at least 30 seconds or any Class I or III AAD after removal from antiarrhythmic drug therapy as assessed from the end of the 3-month blanking period to 12 months following the ablation procedure.|1 year||2020-06-30|06/2020||||
2531094|NCT03354663|Other Pre-specified|One-year Freedom From AF|One-year freedom from AF, defined as freedom from symptomatic AF, atrial flutter (AFL), and atrial tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3-month blanking period.|1 year||2020-06-30|06/2020||||
2531095|NCT03354663|Other Pre-specified|Number of Participants Experiencing a Serious Adverse Event Within 1 Year|Serious adverse events and adverse events related to the procedure and/or ablation catheter through 1 year post index ablation|1 year||2020-06-30|06/2020||||
2531096|NCT03354663|Other Pre-specified|Number of Participants Experiencing Serious Adverse Events Within 30 Days|Serious adverse events and adverse events related to the procedure and/or ablation catheter through 30 days post index ablation. This excludes the events identified in the primary safety endpoint.|30 days|Population includes all subjects with ablation catheter inserted.|||Participants|||Count of Participants
2531097|NCT03354663|Other Pre-specified|Index Cases Achieving ≥ 90% Lesions With ≥ 10 Contact Force|Proportion of index cases achieving ≥ 90% lesions with ≥10g contact force|0 days|Population includes all subjects with at least some radiofrequency energy delivered.|||Participants|||Count of Participants
2531099|NCT03354663|Primary|Number of Participants With Procedural Success|The primary effectiveness endpoint is acute procedural success, where acute procedural success is defined as confirmation of entrance block in all pulmonary veins|0 days|Effectiveness Population - all subjects with device inserted into vasculature|||Participants|||Count of Participants
2531100|NCT03354663|Primary|Rate of Serious Adverse Events|"The primary safety endpoint is the rate of device or procedure-related serious adverse events occurring within 7 days of the index procedure. SAEs related solely to arrhythmia recurrence (without coexisting conditions such as thromboembolism, worsening heart failure, etc.) will not be considered primary safety endpoint events. The SAEs that will be included in this endpoint are:~Atrial-esophageal fistula~AV block~Cardiac Perforation/ Tamponade~Death~Diaphragmatic paralysis~Gastroparesis~Hospitalization~Myocardial Infarction~Pericarditis~Pneumothorax~Pulmonary edema~Pulmonary vein stenosis~Stroke~Thromboembolism~Transient ischemic attack~Vascular access complications~Atrial-esophageal fistula, cardiac perforation/tamponade, and pulmonary vein stenosis that occur >7 days post procedure through 30 days will also contribute to the primary endpoint."|30 days|All subjects with device inserted into vasculature and either experienced a primary endpoint event or completed 30 days of follow up.|||Participants|||Count of Participants
2531101|NCT03353246|Secondary|False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Scan Level|Percentage of CT scans with hematomas within detection limits detected by CT where no hematoma was detected by Infrascanner 2000 TM.|Up to 30 days after first CT scan|Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.|||percentage|CT scans|95% Confidence Interval|Number
2531102|NCT03353246|Secondary|Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Scan Level|Percentage of CT scans with hematomas within detection limits detected by CT that were detected by Infrascanner 2000 TM.|Up to 30 days after first CT scan|Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.|||percentage|CT scans|95% Confidence Interval|Number
2531103|NCT03353246|Secondary|False Negative Value for Bleeds Within Detection Limits by Hematoma Type at the Patient Level|Percentage of subjects with hematomas within detection limits detected by CT where no hematoma was detected by Infrascanner 2000 TM.|Up to 30 days after first CT scan|Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.|||percentage||95% Confidence Interval|Number
2531104|NCT03353246|Secondary|Sensitivity for Bleeds Within Detection Limits by Hematoma Type at the Patient Level|Percentage of subjects with hematomas within detection limits detected by CT that were detected by Infrascanner 2000 TM.|Up to 30 days after first CT scan|Estimates by hematoma type are not mutually exclusive; patients with multiple hematoma types are included in more than one estimate.|||percentage|Hematomas|95% Confidence Interval|Number
2531105|NCT03353246|Secondary|Specificity in Identification of Hematomas Within Detection Limits, at the Patient Level|Percentage of patients with no hematomas within detection limits detected by CT who had no hematoma detected by Infrascanner 2000 TM.|Up to 30 days after first CT scan|For participants who had more than one scan, the first scan was used. Analysis was completed in a subset of participants who had hematomas within detection limits.|||percentage||95% Confidence Interval|Number
2531106|NCT03353246|Secondary|Sensitivity in Identification of Hematomas Within Detection Limits, at the Patient Level|Percentage of subjects with hematomas within detection limits detected by CT who had hematoma detected by Infrascanner 2000 TM.|Up to 30 days after first CT scan|For participants who had more than one scan, the first scan was used. Analysis was completed in a subset of participants who had hematomas within detection limits.|||percentage||95% Confidence Interval|Number
2531107|NCT03353246|Primary|False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level|Percentage of scans with hematomas detected by CT that had no hematoma detected by Infrascanner 2000 TM.|Up to 30 days after first CT scan|Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.|||percentage|Scans|95% Confidence Interval|Number
2531108|NCT03353246|Primary|False Negative Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level|Percentage of patients with hematomas detected by CT that had no hematoma detected by Infrascanner 2000 TM.|Up to 30 days after first CT scan|For participants who had more than one scan, the first scan was used.|||percentage||95% Confidence Interval|Number
2531109|NCT03353246|Primary|False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level|Percentage of scans with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM.|Up to 30 days after first CT scan|Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.|||percentage|Scans|95% Confidence Interval|Number
2531110|NCT03353246|Primary|False Positive Rate of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level|Percentage of patients with no hematomas detected by CT that had hematoma detected by Infrascanner 2000 TM.|Up to 30 days after first CT scan|For participants who had more than one scan, the first scan was used.|||percentage||95% Confidence Interval|Number
2531111|NCT03353246|Primary|Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Scan Level|Percentage of CT scans with no hematomas detected that had no hematoma detected by Infrascanner 2000 TM.|Up to 30 days after first CT scan|Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.|||percentage|Scans|95% Confidence Interval|Number
2531112|NCT03353246|Primary|Specificity of InfraScanner 2000 TM for Detection of Any Size Hematoma at the Patient Level|Percentage of patients with no hematomas detected by CT who had no hematoma detected by Infrascanner 2000 TM.|Up to 30 days after first CT scan|For participants who had more than one scan, the first scan was used.|||percentage||95% Confidence Interval|Number
2531113|NCT03353246|Primary|Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Scan Level|Percentage of CT scans with hematomas detected that had hematoma detected by Infrascanner 2000 TM.|Up to 30 days after first CT scan|Among 500 patients, 443 had only one measurement (CT and InfraScan), 37 had two measurements, 16 had three measurements, 4 had four measurements.|||percentage|Scans|95% Confidence Interval|Number
2531483|NCT03340805|Other Pre-specified|New Inpatient Dialysis|Proportion treated with any replacement therapy that was not a continuation of pre-hospital chronic therapy|Up to 90 days following randomization||||Participants|||Count of Participants
2531114|NCT03353246|Primary|Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level|Percentage of subjects with hematomas detected by CT who had hematoma detected by Infrascanner 2000 TM.|Up to 30 days after first CT scan|For participants who had more than one scan, the first scan was used.|||percentage||95% Confidence Interval|Number
2531115|NCT03352882|Secondary|Tissue Inhibitor of Metalloproteinase-1 and ARFI Correlation|Correlation of tissue inhibitor of metalloproteinase-1, a serum marker of liver stiffness, with baseline ARFI measurements, non-invasive radiographic assessment of liver stiffness|Pre-TIPS and 30 days Post-TIPS creation|This study was terminated early due to low enrollment. Only 1 subject was ever enrolled and as such no data analysis was conducted.||||||
2531116|NCT03352882|Secondary|Hyaluronic Acid and ARFI Correlation|Correlation of hyaluronic acid, a serum marker of liver stiffness, with baseline ARFI measurements, non-invasive radiographic assessment of liver stiffness|Pre-TIPS and 30 days Post-TIPS creation|This study was terminated early due to low enrollment. Only 1 subject was ever enrolled and as such no data analysis was conducted.||||||
2531117|NCT03352882|Secondary|Frequency of Paracentesis and Recurrence of Variceal Bleeding|Difference in frequency of paracentesis and freedom from recurrence of variceal bleeding at 30 days and 12 months post-TIPS placement|30 days Post-TIPS and 12 months Post-TIPS creation|This study was terminated early due to low enrollment. Only 1 subject was ever enrolled and as such no data analysis was conducted.||||||
2531118|NCT03352882|Secondary|PSG (mm hg) and ARFI (m/s) Correlation|Baseline PSG (mm Hg) correlation to baseline liver stiffness by ultrasound ARFI (m/s)|Pre-TIPS and 30 days Post-TIPS creation|This study was terminated early due to low enrollment. Only 1 subject was ever enrolled and as such no data analysis was conducted.||||||
2531119|NCT03352882|Primary|Decrease in Liver Stiffness|The primary study endpoint will be decrease in liver stiffness following TIPS creation as measured by ARFI using mean propagation velocity values in meters per second. Mean normal values and mean values indicating severe fibrosis range about 0.8-1.7 m/s and about 1-3.4 m/s respectively. We hypothesize TIPS creation will reduce the liver stiffness by > 50%. Change in liver stiffness will be correlated to change in PSG.|Pre-TIPS and 30 days Post-TIPS creation|This study was terminated early due to low enrollment. Only 1 subject was ever enrolled and as such no data analysis was conducted.||||||
2531120|NCT03352713|Secondary|Smoking Episodes [Smoking Sample Only]|"[Smoking sample only] Self-reported smoking assessed four times daily (morning, early afternoon, late afternoon/evening, and night) over a 14-day period. A smoking episode is defined as self-reported smoking of more than zero cigarettes and is assessed by the question Since the last prompt, how many cigarettes have you smoked? Participants are asked to input a number into a number field."|14 days||||smoking episodes|||Number
2531121|NCT03352713|Secondary|Binge Eating Episodes [Binge Eating Sample Only]|"[Binge eating sample only] Self-reported binge eating episodes assessed four times daily (morning, early afternoon, late afternoon/evening, and night) over a 14-day period. A binge eating episode is defined as self-reported overeating and loss of control. Overeating is assessed by the question Since the last prompt, when you ate most recently, did you overeat? and is scored as 0 (no) or 1 (yes). Loss of control is assessed by the question When you ate most recently, did you lose control over your eating? and is scored as 1 (not at all) to 5 (totally), where a 4 or 5 is considered loss of control."|14 days|Binge eating sample|||binge eating episodes|||Number
2531122|NCT03352713|Primary|12-item Momentary Self-regulation Questionnaire|Self-reported momentary self-regulation assessed by the momentary self-regulation questionnaire four times daily (morning, early afternoon, late afternoon/evening, and night) over a 14-day period. Each item is scored 1 (not at all) to 5 (extremely). The scale is comprised of four subscales: momentary perseverance, momentary sensation seeking, momentary self-judgment, and momentary mindfulness. Each subscale score is calculated by averaging the responses from three of the scale items. Scores on each subscale range from 1 to 5, with higher subscale scores indicating greater momentary reporting of that facet of self-regulation (perseverance, sensation seeking, self-judgment, or mindfulness).|14 days||||scores on a scale||Standard Deviation|Mean
2531123|NCT03352609|Secondary|Reduce in Self Reported Smoking|An exploratory outcome will be the determination if participants receiving active rTMS report decreased levels of smoking 1 week and 2 weeks after rTMS course.|1 week and 2 weeks after rTMS|Participants did not return follow up phone call||||||
2531124|NCT03352609|Primary|Decrease in Cue Induced Nicotine Craving|Nicotine craving evaluated using Questionnaire on Smoking Urges- Brief (QSU-B) questions modified to a 0-100 analog rating. Higher scores meaning a higher level of craving.|During the one day visit||||Percent change on craving scale||Full Range|Mean
2531125|NCT03352609|Primary|Tolerability Measured by Percent of Participants Completing the rTMS Course|Percent of participants completing the 5 session rTMS course. Hypothesize >75% of participants will complete the 5 treatments.|1 day (single visit)||||Participants|||Count of Participants
2531126|NCT03351933|Primary|Percentage of Subjects Maintaining Protective Anti- HAV Antibody Levels|Percentage of subjects maintaining anti-HAV antibody levels ≥10 mIU/mL up to Day 60 following study treatment administration.|Day 60|The efficacy analysis was performed using the Evaluable Population.There are 26 subjects in the Evaluable Population.|||Participants|||Count of Participants
2531127|NCT03351738|Secondary|Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) to MEDI5884|Treatment-emergent ADA is defined as the sum of treatment-induced ADA (post baseline-positive only) and treatment-boosted ADA (baseline ADA titer that was boosted to a 4-fold or higher level following drug administration).|Day 1 (pre-dose), on Day 8, Day 31 (pre-dose), Day 61 (pre-dose), on Days 151 and 241|As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2531128|NCT03351738|Secondary|Terminal Elimination Half-life (t½) of MEDI5884 After the Last Dose|Terminal half-life is the time required for the plasma concentration to fall by 50% during the terminal phase. The t½ of MEDI5884 after the last dose is reported.|Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151|The PK evaluable population included all participants who received any dose of MEDI5884 with at least one detectable post treatment serum concentration measurement.|||Days||Standard Deviation|Mean
2531160|NCT03351231|Secondary|Apparent Volume of Distribution at Steady State (Vss/F)|The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0|Approximately 2 years|Study terminated, data not reported due to privacy reasons||||||
2531129|NCT03351738|Secondary|Maximum Observed Serum Concentration (Cmax) of MEDI5884 After the Last Dose|Maximum observed serum concentration (Cmax) of MEDI5884 after the last dose is reported.|Day 61 (pre-dose), and on Days 64, 68, 71, 91, 111, and 151|The PK evaluable population included all participants who received any dose of MEDI5884 with at least one detectable post treatment serum concentration measurement.|||μg/mL||Standard Deviation|Mean
2531130|NCT03351738|Secondary|Area Under the Concentration-time Curve for 30 Days (AUC30d) After the Last Dose of MEDI5884|AUC30d after the last dose of MEDI5884 is reported.|Day 61 (pre-dose), and on Days 64, 68, 71, and 91|Pharmacokinetic (PK) evaluable population included all participants who received any dose of MEDI5884 with at least one detectable post treatment serum concentration measurement.|||μg⋅day/mL||Standard Deviation|Mean
2531131|NCT03351738|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C)|Percent change from baseline in HDL-C is reported.|Day 1 (Baseline), and Days 31, 61, and 91|"As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Here, number analyzed signifies number of participants analyzed for the specified time point."|||Percent change||Standard Deviation|Mean
2531132|NCT03351738|Secondary|Change From Baseline in Apolipoprotein B|Change from baseline in apolipoprotein B is reported.|Day 1 (Baseline), and Days 31, 61, and 91|"As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Here, number analyzed signifies number of participants analyzed for the specified time point."|||mg/dL||Standard Deviation|Mean
2531133|NCT03351738|Primary|Number of Participants With Clinically Important Changes in Physical Examinations From Baseline|Number of participants with clinically important changes in physical examinations from baseline are reported. Clinically important changes in physical examinations is defined as any clinical significant difference in general appearance, head, ears, eyes, nose, throat, neck, skin, heart, lung, abdomen, musculoskeletal system, endocrine system, nervous system, height, and weight from baseline.|Day 1 (Baseline) through Day 241|As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated ADA, LDL-C, and TG levels at Day 151 visit.|||Participants|||Count of Participants
2531134|NCT03351738|Primary|Number of Participants With Clinically Important Changes in Laboratory Parameters From Baseline|Number of participants with clinically important changes in laboratory parameters from baseline are reported. Clinically important changes in laboratory parameters is defined as any clinical significant difference in analysis of serum chemistry, hematology, and urine from baseline.|Day 1 (Baseline) through Day 241|As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated ADA, LDL-C, and TG levels at Day 151 visit.|||Participants|||Count of Participants
2531135|NCT03351738|Primary|Number of Participants With Clinically Important Changes in Vital Signs From Baseline|Number of participants with clinically important changes in vital signs from baseline are reported. Vital signs measurements were obtained after the participant had rested in the supine position for at least 10 minutes at the recording time. Clinically important changes in vital signs from baseline is defined as any clinical significant difference in the vital sign parameters (blood pressure, heart rate, body temperature, and respiratory rate) from baseline.|Day 1 (Baseline) through Day 241|As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated ADA, LDL-C, and TG levels at Day 151 visit.|||Participants|||Count of Participants
2531136|NCT03351738|Primary|Number of Participants With Clinically Important Changes in Electrocardiograms (ECGs) From Baseline|Number of participants with clinically important changes in ECGs from baseline are reported. Clinically important changes in ECGs is defined as any clinical significant difference in heart rate, RR interval, PR interval, QRS, and QT intervals from the primary lead of the digital 12-lead ECG from baseline.|Day 1 (Baseline) through Day 241|As-treated population included all participants who received any dose of study drug and analyzed according to the treatment they actually received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated ADA, LDL-C, and TG levels at Day 151 visit.|||Participants|||Count of Participants
2531137|NCT03351738|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.|Day 1 (Baseline) through Day 241|As-treated population: All participants who received any dose of study drug and analyzed according to actual treatment they received. Reported data are through Day 151 for all participants, and Day 241 for participants with elevated anti-drug antibodies (ADA), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG) levels at Day 151 visit.|||Participants|||Count of Participants
2531138|NCT03351699|Secondary|Time to Maximum Concentration (Tmax) of MK-4250 Reached in Plasma|The time to maximum concentration (Vz/F) of MK-4250 in plasma was calculated.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time.|All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E.|||Hours||Full Range|Median
2531159|NCT03351231|Secondary|Accumulation Index (AI)|"The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0.~Accumulation index, calculated based on ratio of area under the curve (AUC) and Cmax at steady state to after the first dose."|Approximately 2 years|Study terminated, data not reported due to privacy reasons||||||
2531139|NCT03351699|Secondary|Apparent Volume of Distribution (Vz/F) of MK-4250|The apparent volume of distribution (Vz/F) of MK-4250 in plasma was calculated.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time.|All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2531140|NCT03351699|Secondary|Apparent Clearance (CL/F) of MK-4250|The apparent clearance (CL/F) of MK-4250 in plasma was calculated.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time.|All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E.|||Liters/Hour||Geometric Coefficient of Variation|Geometric Mean
2531141|NCT03351699|Secondary|Apparent Terminal Half-life (t1/2) of MK-4250|The apparent terminal half-life (t1/2) of MK-4250 in plasma was calculated.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time.|All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2531142|NCT03351699|Secondary|Concentration of MK-4250 at 168 Hours (C168hr)|The concentration of MK-4250 at 168 hours postdose (C168hr) was observed.|168 hours after administration of MK-4250.|All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E.|||μM||Geometric Coefficient of Variation|Geometric Mean
2531143|NCT03351699|Secondary|Maximum Concentration (Cmax) of MK-4250 Reached in Plasma|The maximum concentration (Cmax) of MK-4250 in plasma was observed.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time.|All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E.|||μM||Geometric Coefficient of Variation|Geometric Mean
2531144|NCT03351699|Secondary|Area Under the Concentration-Time Curve From 0 to 168 Hours (AUC0-168) for MK-4250|The area under the concentration-time curve up to 168 hours (AUC0-168) of MK-4250 in plasma was calculated.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, and 168 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time.|All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E.|||μM·Hour||Geometric Coefficient of Variation|Geometric Mean
2531145|NCT03351699|Secondary|Area Under the Concentration-Time Curve From 0 to Infinity (AUC0-inf) for MK-4250|The area under the concentration-time curve extrapolated to infinity (AUC0-inf) of MK-4250 in plasma was calculated.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time.|All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E.|||μM·hour||Geometric Coefficient of Variation|Geometric Mean
2531146|NCT03351699|Secondary|Area Under the Concentration-Time Curve From 0 to Last Measurable Concentration (AUC0-last) for MK-4250|The area under the concentration-time curve up to the last measurable concentration (AUC0-last) of MK-4250 in plasma was calculated.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 120, 168, 192, and 240 hours after administration of MK-4250. For Panel B only, the first three participants additionally had a 72-hour postdose time, and no 240-hour postdose time.|All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E.|||μM·hour||Geometric Coefficient of Variation|Geometric Mean
2531147|NCT03351699|Primary|Percentage of Participants Who Discontinued Study Due to an Adverse Event (AE)|The percentage of participants who discontinued from the study due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.|Up to Day 14|Included all participants who received ≥1 dose of treatment. Panel F did not enroll because the scientific objectives were met following completion of Panel E.|||Percentage of Participants|||Number
2531148|NCT03351699|Primary|Percentage of Participants Experiencing ≥1 Adverse Events (AE)|The percentage of participants experiencing ≥1 AE was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.|Up to Day 14|Included all participants who received ≥1 dose of treatment. Panel F did not enroll because the scientific objectives were met following completion of Panel E.|||Percentage of Participants|||Number
2531149|NCT03351699|Primary|Change From Baseline in Plasma HIV-1 RNA Copies Per mL at 168 Hours|Plasma HIV-1 RNA was measured at Baseline and 168 hours after dosing. The log10 plasma HIV-RNA copies/mL measurements from participants in each panel were pooled and analyzed based on a longitudinal data analysis model. The change from Baseline in plasma HIV-1 RNA in participants administered MK-4250 was compared with historical placebo data.|Baseline and Day 7|All participants who complied with the protocol sufficiently to ensure data would likely exhibit the effects of treatment, according to the scientific model. Compliance included treatment exposure, measurement availability, and lack of major protocol deviations. Panel F did not enroll because the objectives were met following completion of Panel E.|||log10 copies per mL||95% Confidence Interval|Least Squares Mean
2531150|NCT03351335|Secondary|Number of Participants With Satisfaction Responses as Assessed by Patient Satisfaction Questionnaire (PSQ) at Day 90 Post-treatment|"Participant satisfaction was determined by scores on PSQ completed at 90 days post-treatment. The participant completed this assessment while referring to baseline photos on a sponsor-supplied electronic tablet and a hand mirror. Participants were requested to provide information on Please indicate what you think about how the treated areas of your lower face and neck look today. With your face relaxed (do not smile), look in the mirror at the treated area on both sides of your face and compare to the photos taken of both sides of your face prior to your study treatment. First questionnaire was as Compared to when you started the study, how do your lower face, under your chin, and your upper neck look today? Improved (much improved, improved, little improved), no change, worse. Second questionnaire was How would you characterize your satisfaction with the treatment? Satisfied (extremely satisfied, satisfied, slightly satisfied), neither satisfied or dissatisfied, dissatisfied."|Day 90|The FAS population consisted of all participants in the SES population for whom the primary efficacy variable was available (that is all participants who had the baseline and post-baseline value of the primary efficacy variable).|||Participants|||Count of Participants
2531151|NCT03351335|Secondary|Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by a Masked, Qualitative Assessment of Photographs at Day 90 Post-treatment|Masked, qualitative photographic assessment of photographs were obtained using Mirror Photofile software and a Vectra 3D digital imaging system. Experienced physicians evaluated paired pre- and 90-days post-treatment photographs of evaluable participants in a blinded fashion. Each blinded assessor reviewed the image sets and identified the post-treatment photographs according to the following definitions: Change (A change that is noticeable) and No Change (No change is apparent). Blinded assessors were asked to compare pre- and post-treatment photos for noticeable change. When change was noted the assessors were asked to determine which image demonstrated improvement. Assessor data were compiled and analyzed using majority rule for each participant assessed.|Day 90|The FAS population consisted of all participants in the SES population for whom the primary efficacy variable was available (that is all participants who had the baseline and post-baseline value of the primary efficacy variable).|||Participants|||Count of Participants
2531152|NCT03351335|Secondary|Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90 Post-treatment|Overall aesthetic improvement was assessed by a principal investigator using GAIS. The SGAIS was a 5-point scale (-2 to 2) that rates global aesthetic improvement from the pre-treatment appearance in which live observation and photo review were utilized by the participant. The ratings are -2 (much worse), -1 (worse), 0 (no change), 1 (improved), and 2 (much improved). Improvement is determined by participant response rate (improved or much improved) on SGAIS.|Day 90|The FAS population consisted of all participants in the SES population for whom the primary efficacy variable was available (that is all participants who had the baseline and post-baseline value of the primary efficacy variable).|||Participants|||Count of Participants
2531153|NCT03351335|Secondary|Number of Participants With Improvement From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area as Assessed by Physician Global Aesthetic Improvement Scale (PGAIS) Scores at Day 90 Post-treatment|Overall aesthetic improvement was assessed by a principal investigator using global aesthetic improvement scale (GAIS).The PGAIS was a 5-point scale (-2 to 2) that rates global aesthetic improvement from the pre-treatment appearance in which live observation and photo review were utilized by the physician. The ratings are -2 (much worse), -1 (worse), 0 (no change), 1 (improved), and 2 (much improved). Improvement was determined by participant response rate (improved or much improved) on PGAIS.|Day 90|The FAS population consisted of all participants in the SES population for whom the primary efficacy variable was available (that is all participants who had the baseline and post-baseline value of the primary efficacy variable).|||Participants|||Count of Participants
2531154|NCT03351335|Primary|Mean Change From Baseline in Overall Lifting and Tightening of Submental (Under the Chin) and Neck Tissue Area at Day 90 Post-treatment|Lifting was determined by a quantitative measure of tissue lift in the area using photographs taken with Mirror Photofile software and a Vectra 3 dimensional (3D) digital imaging system. Mean change was calculated as mean of left and right side 90 day area minus mean of left and right baseline area.|Baseline and Day 90|The full analysis set (FAS) population consisted of all participants in the SES population for whom the primary efficacy variable was available (that is all participants who had the baseline and post-baseline value of the primary efficacy variable).|||square millimeter (mm^2)||Standard Deviation|Mean
2531155|NCT03351231|Secondary|Overall Response Rate (ORR)|ORR in participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors|Approximately 2 years|Study terminated, data not reported due to privacy reasons||||||
2531156|NCT03351231|Secondary|Incidence of Anti-drug Antibody (ADA) to Nivolumab in Combination With BMS-986242|Baseline ADA-positive participant is defined as a participant who has a ADA detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment.|Approximately 2 years|Study terminated, data not reported due to privacy reasons||||||
2531157|NCT03351231|Secondary|Percent Urinary Recovery Over 72 Hours (%UR72)|The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0|Approximately 2 years|Study terminated, data not reported due to privacy reasons||||||
2531161|NCT03351231|Secondary|Apparent Total Body Clearance (CLT/F)|The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0|Approximately 2 years|Study terminated, data not reported due to privacy reasons||||||
2531162|NCT03351231|Secondary|Apparent Elimination Half-life (T-HALF)|The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0|Approximately 2 years|Study terminated, data not reported due to privacy reasons||||||
2531163|NCT03351231|Secondary|Trough Observed Plasma Concentration at the End of the Dosing Interval (Ctrough)|The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0|Approximately 2 years|Study terminated, data not reported due to privacy reasons||||||
2531164|NCT03351231|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity [AUC(INF)]|The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0|Approximately 2 years|Study terminated, data not reported due to privacy reasons||||||
2531165|NCT03351231|Secondary|Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)]|The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0|Approximately 2 years|Study terminated, data not reported due to privacy reasons||||||
2531166|NCT03351231|Secondary|Time of Maximum Observed Plasma Concentration (Tmax)|The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0|Approximately 2 years|Study terminated, data not reported due to privacy reasons||||||
2531167|NCT03351231|Secondary|Maximum Observed Plasma Concentration (Cmax)|The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0|Approximately 2 years|Study terminated, data not reported due to privacy reasons||||||
2531168|NCT03351231|Primary|Number of Participants With Laboratory Abnormalities|The primary objective to establish safety to be measured by the primary endpoint of clinical laboratory test abnormalities|Approximately 2 years|Study terminated, data not reported due to privacy reasons|||Number of participants|||Number
2531169|NCT03351231|Primary|Number of Deaths|The primary objective to establish safety to be measured by the primary endpoint of deaths|Approximately 2 years|Study terminated, data not reported due to privacy reasons|||Number of deaths|||Number
2531170|NCT03351231|Primary|Number of Participants With AEs Leading to Discontinuation|The primary objective to establish safety to be measured by the primary endpoint of AEs leading to discontinuation|Approximately 2 years|Study terminated, data not reported due to privacy reasons|||Number of participants|||Number
2531171|NCT03351231|Primary|Number of Participants With Dose Limiting Toxicities (DLT)|The primary objective to establish safety to be measured by the primary endpoint of dose limiting toxicities|Approximately 2 years|Study terminated, data not reported due to privacy reasons|||Number of participants|||Number
2531172|NCT03351231|Primary|Number of Participants With Serious Adverse Events (SAE)|The primary objective to establish safety to be measured by the primary endpoint of SAEs|From the date of participant's written consent until 100 days after discontinuation of nivolumab or participation in the study|Study terminated, data not reported due to privacy reasons|||Number of participants|||Number
2531173|NCT03351231|Primary|Number of Participants With Adverse Events (AE)|The primary objective to establish safety to be measured by the primary endpoint of AEs|From initiation of study treatment until 100 days after discontinuation of study treatment|Study terminated, data not reported due to privacy reasons|||Number of participants|||Number
2531174|NCT03350984|Secondary|Number of Participants With Sustained Glycemic Control During Hospital Stay|Sustained glycemic control were the number of participants who not had: discharged before sustained control, critical status suspension, death before control, bad attachment to the protocol, interruption due to more than 2 hypoglycemic events during their hospital stay.|blood glucose was taken every day, up to 4 weeks.||||Participants|||Count of Participants
2531175|NCT03350984|Secondary|the Number of Participants With Mild and Severe Hypoglycemic Events|To measure the number of participants with mild and severe hypoglycemic events|Duration of hospital stay, up to 4 weeks.||||Participants|||Count of Participants
2531176|NCT03350984|Primary|Differences in the Mean Daily Blood Glucose Between a Physiological and Traditional Schemes of Insulin.|To determine the differences in the mean daily blood glucose measured in mg/dl, between a physiological and traditional schemes of insulin measured by the mean daily blood glucose.|Fasting blood glucose was taken every day, before breakfast, up to 4 weeks; postprandial glucose was taken every day, 2 hours after breakfast, 2 hours after lunch, and 2 hours after dinner, up to 4 weeks; glucose early morning was taken 3 am, up to 4 week||||mg/dl||Standard Deviation|Mean
2531177|NCT03350724|Secondary|Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test|The non-invasive peroxide test is based on the principle that if the epithelium is discontinuous, the H2O2 diffuses into the connective tissue; the enzyme catalase acts on H2O2 to release water and oxygen: this is clinically shown by the production of bubbles on the wound. 3% H2O2 will be applied to the FGG donor site with a syringe and the appearance of bubbles will be recorded as a dichotomous variable (yes/no).|21 days postoperatively||||Participants|||Count of Participants
2531178|NCT03350724|Secondary|Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test|The non-invasive peroxide test is based on the principle that if the epithelium is discontinuous, the H2O2 diffuses into the connective tissue; the enzyme catalase acts on H2O2 to release water and oxygen: this is clinically shown by the production of bubbles on the wound. 3% H2O2 will be applied to the FGG donor site with a syringe and the appearance of bubbles will be recorded as a dichotomous variable (yes/no).|14 days postoperatively||||Participants|||Count of Participants
2531204|NCT03350256|Secondary|Change in Pain Catastrophizing Scale Between Baseline and Follow up 2|Questionnaire on pain catastrophizing (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)|Baseline and 3 month follow up visit|Change in PCS between baseline and 3 month follow up 2 subjects had missing data|||score on a scale||Standard Deviation|Mean
2531179|NCT03350724|Secondary|Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test|The non-invasive peroxide test is based on the principle that if the epithelium is discontinuous, the H2O2 diffuses into the connective tissue; the enzyme catalase acts on H2O2 to release water and oxygen: this is clinically shown by the production of bubbles on the wound. 3% H2O2 will be applied to the FGG donor site with a syringe and the appearance of bubbles will be recorded as a dichotomous variable (yes/no).|7 days postoperatively||||Participants|||Count of Participants
2531180|NCT03350724|Secondary|Number of Participants With Re-epithelialization of the FGG Donor Site as Indicated by a Non-invasive Peroxide Test|The non-invasive peroxide test is based on the principle that if the epithelium is discontinuous, the H2O2 diffuses into the connective tissue; the enzyme catalase acts on H2O2 to release water and oxygen: this is clinically shown by the production of bubbles on the wound. 3% H2O2 will be applied to the FGG donor site with a syringe and the appearance of bubbles will be recorded as a dichotomous variable (yes/no).|3 days postoperatively||||Participants|||Count of Participants
2531181|NCT03350724|Secondary|Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)|The laser Doppler flowmetry (LDF) technique to measure the blood perfusion of the FGG donor site. The value reported is blood flow at the FGG donor site (operated site) minus blood flow at the contralateral side of the palate (non-operated site). Perfusion Units (PU) are reported, which is blood flow through a given volume or mass of tissue with the unit of measure mL/100g/min.|21 days postoperatively||||mL/100g/min||Standard Deviation|Mean
2531182|NCT03350724|Secondary|Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)|The laser Doppler flowmetry (LDF) technique to measure the blood perfusion of the FGG donor site. The value reported is blood flow at the FGG donor site (operated site) minus blood flow at the contralateral side of the palate (non-operated site). Perfusion Units (PU) are reported, which is blood flow through a given volume or mass of tissue with the unit of measure mL/100g/min.|14 days postoperatively||||mL/100g/min||Standard Deviation|Mean
2531183|NCT03350724|Secondary|Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)|The laser Doppler flowmetry (LDF) technique to measure the blood perfusion of the FGG donor site. The value reported is blood flow at the FGG donor site (operated site) minus blood flow at the contralateral side of the palate (non-operated site). Perfusion Units (PU) are reported, which is blood flow through a given volume or mass of tissue with the unit of measure mL/100g/min.|7 days postoperatively||||mL/100g/min||Standard Deviation|Mean
2531184|NCT03350724|Secondary|Gingival Blood Flow as Measured Laser Doppler Flowmetry (LDF)|The laser Doppler flowmetry (LDF) technique to measure the blood perfusion of the FGG donor site. The value reported is blood flow at the FGG donor site (operated site) minus blood flow at the contralateral side of the palate (non-operated site). Perfusion Units (PU) are reported, which is blood flow through a given volume or mass of tissue with the unit of measure mL/100g/min.|3 days postoperatively|One patient was not able to have Day 3 laser Doppler flowmetry (LDF) readings because of a death in the family, and this patient had to travel out of town for several days.|||mL/100g/min||Standard Deviation|Mean
2531185|NCT03350724|Secondary|Gingival Blood Flow as Measured Laser Doppler Flometry (LDF)|The laser Doppler flowmetry (LDF) technique to measure the blood perfusion of the free gingival graft (FGG) donor site. The value reported is blood flow at the FGG donor site (operated site) minus blood flow at the contralateral side of the palate (non-operated site). Perfusion Units (PU) are reported, which is blood flow through a given volume or mass of tissue with the unit of measure mL/100g/min.|baseline (on the day of surgery before surgery)||||mL/100g/min||Standard Deviation|Mean
2531186|NCT03350724|Primary|Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day|Postoperative pain will be determined by the subjects recording the number of analgesic pills taken each day.|21 days postoperatively||||number of Ibuprofen 600mg tablets||Inter-Quartile Range|Median
2531187|NCT03350724|Primary|Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day|Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.|14 days postoperatively||||number of Ibuprofen 600mg tablets||Inter-Quartile Range|Median
2531188|NCT03350724|Primary|Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day|Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.|10 days postoperatively||||number of Ibuprofen 600mg tablets||Inter-Quartile Range|Median
2531189|NCT03350724|Primary|Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day|Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.|7 days postoperatively||||number of Ibuprofen 600mg tablets||Inter-Quartile Range|Median
2531190|NCT03350724|Primary|Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day|Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.|5 days postoperatively||||number of Ibuprofen 600mg tablets||Inter-Quartile Range|Median
2531191|NCT03350724|Primary|Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day|Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.|3 days postoperatively||||number of Ibuprofen 600mg tablets||Inter-Quartile Range|Median
2531192|NCT03350724|Primary|Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day|Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.|2 days postoperatively||||number of Ibuprofen 600mg tablets||Inter-Quartile Range|Median
2531193|NCT03350724|Primary|Postoperative Pain as Assessed by the Number of Analgesic Pills Taken Each Day|Postoperative pain will be determined by the subjects recording the number of analgesic pills (Ibuprofen 600mg tablets) taken each day.|1 day postoperatively||||number of Ibuprofen 600mg tablets||Inter-Quartile Range|Median
2531205|NCT03350256|Secondary|Change in Pain Catastrophizing Scale Between Baseline and Follow up 1|Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)|Baseline and 1 month follow up visit|Change in PCS score between baseline and 1 month follow up 2 subjects had missing data|||score on a scale||Standard Deviation|Mean
2531594|NCT03334825|Primary|Number of Participants With Placement in Permanent Housing|supportive housing, rental assistance, other non-emergency housing, etc.|12 months post-enrollment|persons who survived 12 months post-enrollment|||Participants|||Count of Participants
2531194|NCT03350724|Primary|Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale|"Postoperative pain will be determined by the subjects recording their postoperative pain threshold using a Visual Analog Scale with scores from 1 to 10, with 1 indicating minimal pain and 10 indicating severe pain. If no pain is present, a score of 0 will be given. The levels of postoperative pain will be classified as none to minimum if the score is 0 to 3, moderate for 4 to 6, and severe for 7 to 10. None to minimal pain will mean little or no discomfort; moderate is any pain that bothers the subject and mildly affects normal function; and severe will be considered any pain that will not be tolerated and may even disrupt the subject's daily functions."|21 days postoperatively||||Participants|||Count of Participants
2531195|NCT03350724|Primary|Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale|"Postoperative pain will be determined by the subjects recording their postoperative pain threshold using a Visual Analog Scale with scores from 1 to 10, with 1 indicating minimal pain and 10 indicating severe pain. If no pain is present, a score of 0 will be given. The levels of postoperative pain will be classified as none to minimum if the score is 0 to 3, moderate for 4 to 6, and severe for 7 to 10. None to minimal pain will mean little or no discomfort; moderate is any pain that bothers the subject and mildly affects normal function; and severe will be considered any pain that will not be tolerated and may even disrupt the subject's daily functions."|14 days postoperatively||||Participants|||Count of Participants
2531196|NCT03350724|Primary|Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale|"Postoperative pain will be determined by the subjects recording their postoperative pain threshold using a Visual Analog Scale with scores from 1 to 10, with 1 indicating minimal pain and 10 indicating severe pain. If no pain is present, a score of 0 will be given. The levels of postoperative pain will be classified as none to minimum if the score is 0 to 3, moderate for 4 to 6, and severe for 7 to 10. None to minimal pain will mean little or no discomfort; moderate is any pain that bothers the subject and mildly affects normal function; and severe will be considered any pain that will not be tolerated and may even disrupt the subject's daily functions."|10 days postoperatively||||Participants|||Count of Participants
2531197|NCT03350724|Primary|Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale|"Postoperative pain will be determined by the subjects recording their postoperative pain threshold using a Visual Analog Scale with scores from 1 to 10, with 1 indicating minimal pain and 10 indicating severe pain. If no pain is present, a score of 0 will be given. The levels of postoperative pain will be classified as none to minimum if the score is 0 to 3, moderate for 4 to 6, and severe for 7 to 10. None to minimal pain will mean little or no discomfort; moderate is any pain that bothers the subject and mildly affects normal function; and severe will be considered any pain that will not be tolerated and may even disrupt the subject's daily functions."|7 days postoperatively||||Participants|||Count of Participants
2531198|NCT03350724|Primary|Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale|"Postoperative pain will be determined by the subjects recording their postoperative pain threshold using a Visual Analog Scale with scores from 1 to 10, with 1 indicating minimal pain and 10 indicating severe pain. If no pain is present, a score of 0 will be given. The levels of postoperative pain will be classified as none to minimum if the score is 0 to 3, moderate for 4 to 6, and severe for 7 to 10. None to minimal pain will mean little or no discomfort; moderate is any pain that bothers the subject and mildly affects normal function; and severe will be considered any pain that will not be tolerated and may even disrupt the subject's daily functions."|5 days postoperatively||||Participants|||Count of Participants
2531199|NCT03350724|Primary|Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale|"Postoperative pain will be determined by the subjects recording their postoperative pain threshold using a Visual Analog Scale with scores from 1 to 10, with 1 indicating minimal pain and 10 indicating severe pain. If no pain is present, a score of 0 will be given. The levels of postoperative pain will be classified as none to minimum if the score is 0 to 3, moderate for 4 to 6, and severe for 7 to 10. None to minimal pain will mean little or no discomfort; moderate is any pain that bothers the subject and mildly affects normal function; and severe will be considered any pain that will not be tolerated and may even disrupt the subject's daily functions."|3 days postoperatively||||Participants|||Count of Participants
2531200|NCT03350724|Primary|Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale|"Postoperative pain will be determined by the subjects recording their postoperative pain threshold using a Visual Analog Scale with scores from 1 to 10, with 1 indicating minimal pain and 10 indicating severe pain. If no pain is present, a score of 0 will be given. The levels of postoperative pain will be classified as none to minimum if the score is 0 to 3, moderate for 4 to 6, and severe for 7 to 10. None to minimal pain will mean little or no discomfort; moderate is any pain that bothers the subject and mildly affects normal function; and severe will be considered any pain that will not be tolerated and may even disrupt the subject's daily functions."|2 days postoperatively||||Participants|||Count of Participants
2531201|NCT03350724|Primary|Postoperative Pain as Assessed by Number of Participants With a Score of 0-3 (no to Minimal Pain) on a Visual Analog Scale|"Postoperative pain will be determined by the subjects recording their postoperative pain threshold using a Visual Analog Scale with scores from 1 to 10, with 1 indicating minimal pain and 10 indicating severe pain. If no pain is present, a score of 0 will be given. The levels of postoperative pain will be classified as none to minimum if the score is 0 to 3, moderate for 4 to 6, and severe for 7 to 10. None to minimal pain will mean little or no discomfort; moderate is any pain that bothers the subject and mildly affects normal function; and severe will be considered any pain that will not be tolerated and may even disrupt the subject's daily functions."|1 day postoperatively||||Participants|||Count of Participants
2531202|NCT03350256|Other Pre-specified|Stimulation ON/OFF Ratio|Percentage of patients using each ON/OFF ratio|6 month follow up visit||||Participants|||Count of Participants
2531203|NCT03350256|Secondary|Change in Pain Catastrophizing Scale Between Baseline and Follow up 3|Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)|Baseline and 6 month follow up visit|"Change in PCS score between baseline and 6 month follow up~1 subject had missing data"|||score on a scale||Standard Deviation|Mean
2531206|NCT03350256|Secondary|Change in Pain Catastrophizing Scale Between Baseline and Trial Stimulation|Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)|Baseline and 1 week after trial lead implant (trial stimulation)|Change in PCS between baseline and SCS trial One subject had missing data|||score on a scale||Standard Deviation|Mean
2531207|NCT03350256|Secondary|Change in Disability Index Between Baseline and and Follow up 3|questionnaire on disability (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)|Baseline and 6 month follow up visit|Change in disability score between baseline and 6 month follow up|||score on a scale||Standard Deviation|Mean
2531208|NCT03350256|Secondary|Change in Disability Index Between Baseline and and Follow up 2|questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)|Baseline and 3 month follow up visit|Change in disability score between baseline and 3 month follow up Two subjects had missing data|||score on a scale||Standard Deviation|Mean
2531209|NCT03350256|Secondary|Change in Disability Index Between Baseline and and Follow up 1|questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)|Baseline and 1 month follow up visit|Change in ODI score between baseline and 1 month follow up 2 subjects had missing data|||score on a scale||Standard Deviation|Mean
2531210|NCT03350256|Secondary|Change in Disability Index Between Baseline and Trial Stimulation|questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)|Baseline and 1 week after trial lead implant (trial stimulation)|Change in ODI score between baseline and SCS trial 3 subjects had missing data|||score on a scale||Standard Deviation|Mean
2531211|NCT03350256|Secondary|Change in Quality of Life Between Baseline and Follow up 3|Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)|Baseline and 6 month follow up visit|Change in EQ-5D score between baseline and 6 month follow up|||score on a scale||Standard Deviation|Mean
2531212|NCT03350256|Secondary|Change in Quality of Life Between Baseline and Follow up 2|Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)|Baseline and 3 month follow up visit|Change in EQ-5D score between baseline and 3 month follow up One subjects had missing data|||score on a scale||Standard Error|Mean
2531213|NCT03350256|Secondary|Change in Quality of Life Between Baseline and Follow up 1|Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)|Baseline and 1 month follow up visit|Change in EQ-5D score between baseline and 1 month follow up Two subjects had missing data|||score on a scale||Standard Deviation|Mean
2531214|NCT03350256|Secondary|Change in Quality of Life Between Baseline and Trial Stimulation|Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)|Baseline and 1 week after trial lead implant (trial stimulation)|"Change in EQ-5D score between baseline and SCS trial~1 subject had missing data"|||score on a scale||Standard Deviation|Mean
2531215|NCT03350256|Primary|Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 3|Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)|Baseline and 6 month follow up visit|Change in VAS score between baseline and 6 months visit|||units on a scale||Standard Deviation|Mean
2531216|NCT03350256|Primary|Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 2|Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)|Baseline and 3 month follow up visit|Change in VAS between baseline and 3 month follow up missing data for 2 subject|||units on a scale||Standard Deviation|Mean
2531217|NCT03350256|Primary|Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 1|Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)|Baseline and 1 month follow up visit|Change in VAS score between baseline and 1 month follow up missing data for 2 subjects|||units on a scale||Standard Deviation|Mean
2531218|NCT03350256|Primary|Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation|Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)|baseline and 1 week after trial lead implant (trial stimulation)|Change in visual analogue scale score between baseline and spinal cord stimulation (SCS) trial missing data for 3 subjects|||units on a scale||Standard Deviation|Mean
2531219|NCT03350217|Secondary|Safety Outcomes as Assessed by Complications During or After the Procedure|To evaluate the safety of Eleview for EMR procedures in relation to adverse events and occurrence of complications during and after the EMR procedure in comparison to Hetastarch injectate.|during large polyp removal through 30 days post procedure|There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 114 lesions included in the Eleview arm. For the same reason, there are 81 patients but 102 polyps in the Hetastarch group.|||Polyps|Large polyps||Number
2531220|NCT03350217|Secondary|Time Required to Remove the Lesion|Time (in minutes) to remove the lesion completely (measured from the first injection to final excision of the lesion)|During the large polyp removal|Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps.|||minutes|Large polyps|Standard Deviation|Mean
2531221|NCT03350217|Secondary|Need for Additional Treatments Relating to the Polyp Resection Such as Avulsion, Coagulation or Ablation.|Need for additional treatments relating to the polyp resection such as avulsion, coagulation or ablation. These treatments can be done in addition to endoscopic mucosal resection (EMR) in order to remove polyp tissue/treat the defect.|During the large polyp removal|There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 114 lesions included in the Eleview arm. For the same reason, there are 81 patients but 102 polyps in the Hetastarch group.|||Polyps requiring additional treatments|Large polyps||Number
2531222|NCT03350217|Secondary|Ease of Injection|Comparison of how easily the fluid was able to be injected. This was rated by the endoscopy technician assisting in the large polyp removal. It was rated on the following scale: Very Easy, Easy, Difficult, Very Difficult.|During the large polyp removal|Since some patients had more than one eligible polyp included in the study, there are 114 polyps but only 77 patients in the Eleview arm and 102 polyps but only 81 patients in the Hetastarch arm.|||Polyps|Large Polyps||Number
2531223|NCT03350217|Secondary|Mound Duration|Comparison of how long the injection fluid was able to keep the polyp lifted during the large polyp removal between Eleview and Hetastarch. This was rating using the following scale: Excellent, Sufficient, or Inadequate. The longer the injection fluid stayed concentrated and kept the polyp lifted, the better rating it received while rapid dissipation of the fluid would receive a worse rating.|During the large polyp removal|Since some patients had more than one eligible polyp included in the study, there are 114 polyps but only 77 patients in the Eleview arm and 102 polyps but only 81 patients in the Hetastarch arm.|||Polyps|Large Polyps||Number
2531224|NCT03350217|Secondary|Mound Concentration Height|Comparison of how well the injection fluid lifted the polyp during the large polyp removal between Eleview and Hetastarch rated by the following scale: Excellent, Sufficient, Inadequate. The more the polyp was able to be lifted vertically, the better the rating would be.|During the large polyp removal|There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 114 lesions included in the Eleview arm. For the same reason, there are 81 patients but 102 polyps in the Hetastarch group.|||Polyps|Large Polyps||Number
2531225|NCT03350217|Secondary|Mound Concentration Diameter|Comparison fluid behavior and ease of use between Eleview and Hetastarch rated on a 3-point scale (Excellent, Sufficient, or Inadequate). The more the fluid spread out laterally after being injected, the worse the rating would be. The more the fluid stayed concentrated around the polyp after injection, the better the rating would be.|During the large polyp removal|There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 114 lesions included in the Eleview arm. For the same reason, there are 81 patients but 102 polyps in the Hetastarch group.|||Polyps|Large Polyps||Number
2531226|NCT03350217|Secondary|Number of Pieces Resected Using Snares|Comparison of the number of pieces removed using snare between polyps injected with Eleview compared with polyps injected with Hetastarch.|During the large polyp removal|Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps.|||polyp pieces resected|Large polyps|Standard Deviation|Mean
2531227|NCT03350217|Secondary|Number of En Bloc Resections|Comparison of the number of polyps that were able to be removed in one piece during the resection between polyps injected with Eleview and polyps injected with Hetastarch|During the large polyp removal|There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 84 adenomas and 30 serrated lesions included in the Eleview arm. For the same reason, there are 81 patients but 75 adenomas and 27 serrated lesions in the Hetastarch group.|||Polyps|Large Polyps||Number
2531228|NCT03350217|Secondary|Number of Re-injections Needed During Resection|Comparison of the number of re-injections needed during the large polyp removal. Number of re-injections is the number of times the injection device is passed down the scope to inject the polyp after initial injection during the large polyp resection.|During the large polyp removal|Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps.|||reinjections|Large polyps|Standard Deviation|Mean
2531229|NCT03350217|Secondary|Injected Volume Needed for Complete Removal of Lesion|Comparison of the volume of injection fluid needed for complete removal of lesion between Eleview and Hetastarch|During the large polyp removal|Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps.|||milliliters|Large polyps|Standard Deviation|Mean
2531230|NCT03350217|Secondary|Injected Volume Needed for Initial Lesion Lift|Comparison of the volume of injection fluid needed for initial lesion lift of Eleview vs Hetastarch.|During initial injection portion of large polyp removal|Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps.|||milliliters|Large polyps|Standard Deviation|Mean
2531231|NCT03350217|Primary|Sydney Resection Quotient (SRQ)|Comparison of the Sydney Resection Quotient between EMRs done using Eleview vs EMRs done using Hetastartch as the injection fluid. The Sydney Resection Quotient (SRQ) is the size of the polyp divided by the number of pieces in which the polyp was resected. A larger SRQ is better than a smaller SRQ.|During the large polyp removal|Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps.|||Ratio|Large polyps|Standard Deviation|Mean
2531232|NCT03349632|Primary|Overall Quality of Vision|"Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked Thinking back over the last week, please rate our study lenses. Rate eyes together. No formal hypotheses was conducted; hence no inferential testing was performed."|Day 8, each product|Safety Analysis Set|||units on a scale||Standard Deviation|Mean
2531233|NCT03349515|Primary|Breath Duration|The iPhone stopwatch application will be used and its 'lap button' feature to collect the respiration peak intervals (in seconds) for 5 breaths. Specifically, at the patient's peak inspiration (as seen on the capnography), the study member will start the stopwatch and proceed to hit the 'lap' button for the next 5 consecutive inspiration peaks. These data intervals will be recorded on the data sheet after the 5 breaths are over, as the intervals are conveniently stored and numbered below the stopwatch in the app|5 minutes||||seconds||Standard Error|Mean
2531234|NCT03349437|Primary|Average Distance During Modified 6 Minute Walk Test|Compare the average distance walked during modified 6 minute walk test (M 6MWT) by COPD participants using Pursed Lip Breathing (PLB) versus an intermittent positive airway pressure handheld device, VitaBreath.|15 minutes||||meters||Standard Deviation|Mean
2531235|NCT03349333|Secondary|Terminal Phase Half-life [t1/2Z] for S-pralatrexate|The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.|Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）|PK population|||h||Standard Deviation|Mean
2531236|NCT03349333|Secondary|Terminal Phase Half-life [t1/2Z] for R-pralatrexate|The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.|Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）|PK population|||h||Standard Deviation|Mean
2531237|NCT03349333|Secondary|Time of Cmax Observation [Tmax] for S-pralatrexate|The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.|Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）|PK population|||h||95% Confidence Interval|Median
2531238|NCT03349333|Secondary|Time of Cmax Observation [Tmax] for R-pralatrexate|The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.|Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）|PK population|||h||95% Confidence Interval|Median
2531239|NCT03349333|Secondary|Maximum Observed Plasma Concentration [Cmax] for S-pralatrexate|The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.|Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2531240|NCT03349333|Secondary|Maximum Observed Plasma Concentration [Cmax] for R-pralatrexate|The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.|Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2531241|NCT03349333|Secondary|Steady State Clearance [CLss] for S-pralatrexate|The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.|Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）|PK population|||L/h||Standard Deviation|Mean
2531242|NCT03349333|Secondary|Steady State Clearance [CLss] for R-pralatrexate|The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.|Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）|PK population|||L/h||Standard Deviation|Mean
2531243|NCT03349333|Secondary|Steady State Volume of Distribution [Vdss] for S-pralatrexate|The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.|Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）|PK population|||L||Standard Deviation|Mean
2531244|NCT03349333|Secondary|Steady State Volume of Distribution [Vdss] for R-pralatrexate|The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.|Cycle 1 day 1, Cycle 1 week6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection)|PK population|||L||Standard Deviation|Mean
2531245|NCT03349333|Secondary|Area Under the Curve [AUC] for S-pralatrexate|The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.|Cycle 1 day 1, Cycle 1 week 6（Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection）|PK population|||h*ng/ml||Geometric Coefficient of Variation|Geometric Mean
2531246|NCT03349333|Secondary|Area Under the Curve [AUC] for R-pralatrexate|The PK endpoints was analysed using the PK population. The overall PK population is defined as all subjects who receive at least one dose of Investigational Medicinal Product (IMP) and have at least one primary PK parameter. Subjects with non-zero baseline concentrations of >5% of Cmax for either analyte (R-pralatrexate or S-pralatrexate) will be removed from the PK population.|Cycle 1 day1，Cycle 1 week 6(Pre-injection, end-injection, 30 and 60 minutes, and 3, 5, 8, 12, 18, 24, 48, and 72 hours post-end injection)|Based on PK population|||h*ng/ml||Geometric Coefficient of Variation|Geometric Mean
2531247|NCT03349333|Secondary|Percentage of Participants With Treatment Emergent Adverse Events|treatment emergent AE was scheduled to be collected during all subject visits, the data evaluated as clinical significant will be summarized and presented.|4 years|safety population|||percentage of participants|||Number
2531248|NCT03349333|Secondary|Duration of Responses|Duration of response was measured from first day of documented response to disease progression or death, whatever comes first.|4 years|The secondary analyses was performed using the safety population and repeated using the per-protocol population.|||months||95% Confidence Interval|Median
2531249|NCT03349333|Secondary|Overall Survival (OS)|OS was measured from treatment day 1 until death or censoring.|4 years|The secondary analyses was performed using the safety population and repeated using the per-protocol population.|||months||95% Confidence Interval|Median
2531250|NCT03349333|Secondary|Progression-Free Survival (PFS)|PFS was measured from treatment day 1 until event or censoring. An event was defined as the earliest of the following: death from any cause or disease progression. Subjects undergoing transplant or any other subsequent therapy prior to documentation of PD was censored at that time. Progression of disease deems as 1. 50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders, 2.Appearance of any new lesion during or at the end of therapy as per IWC criteria.|2 years|The secondary analyses was performed using the safety population and repeated using the per-protocol population.|||months||95% Confidence Interval|Median
2531251|NCT03349333|Secondary|Time to Response (TTR)|Time to response was measured from first day of treatment to the first date of documented response.|2 years|The secondary analyses was performed using the safety population and repeated using the per-protocol population.|||months||Standard Deviation|Mean
2531252|NCT03349333|Primary|Objective Response Rate(ORR) by International Working Group Criteria|"ORR defined as the percentage of subjects with CR, CRu or PR as Best Overall Response.Evaluation of response must be performed within 7 days prior to the projected first dose of cycle 2-4 and then within 7 days prior to the projected first dose of every even-numbered subsequent cycle (i.e. prior to cycles 6, 8, etc). Unscheduled radiological response assessments will be performed earlier if clinical progression is suspected.The primary analysis will be conducted once all subjects have completed cycle 5 treatment or discontinued before. Study treatment may continue per investigator judgment for a maximum of 24 months.~Response will be assessed on the basis of clinical, radiological, and pathological criteria. Response will be assessed by independent central review and by the treating investigator. Central review assessors will be blinded to the response assessments by the treating investigator. The primary analysis will be based on response assessed by central review."|2 years|The primary analysis was based on the independent review data using the safety population, safety population is 71 for this study|||Participants|||Count of Participants
2531253|NCT03349099|Secondary|Ease of Sheath Placement|Surgeons will be asked to subjectively rate the ease of placement on a standardized scale from 0 to 4, 4 being easiest which will be rated by the surgeon who inserted the sheath immediately after placement.|One time point - at the completion of the procedure|patients undergoing ureteroscopy with each device.|||units on a scale|||Number
2531254|NCT03349099|Secondary|Number of Participants With Injury to the Ureter|Subjective rating of damage to ureter. At the completion of the procedure, video of the intraluminal ureter is recorded as the sheath is withdrawn. Videos are analyzed by two blinded staff endourologists who score ureteral injury on a standard 5-point scale (0 to 4); reference Traxer and Thomas.|One time point - at the completion of the procedure|Patients undergoing procedures with each device.|||Participants|||Count of Participants
2531255|NCT03349099|Primary|Number of Participants With Successful Sheath Placement|The surgeon documents whether there was Successful placement of sheath (yes or no)|One time point - at the beginning of the procedure||||Participants|||Count of Participants
2531256|NCT03349060|Secondary|Plasma Concentration Versus Time Summary of PF-04965842|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ) = =1.00 nanogram per milliliter (ng/mL) to zero.|Day 1 of Week 4: 0 hour(Pre-dose), 0.5 hours post-dose; Day 1 of Week 12: 0.5, 4 hours post-dose|Analysis set included all randomized participants who received at least 1 dose of PF-04965842 and had pharmacokinetic measurements. Here, ‘Number Analyzed’ = participants evaluable for the specified time points.|||ng/mL||Standard Deviation|Mean
2531257|NCT03349060|Secondary|Change From Baseline in Short Form-36v2 Acute Summary Score at Week 12: Mental Component Summary|SF-36v2 health survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were also summarized as physical and mental component summary scores. Mental component summary: the minimum score is 0 and the maximum score is 100. Higher scores indicates a better health state.|Baseline, Week 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2531258|NCT03349060|Secondary|Change From Baseline in Short Form-36v2 (SF-36v2) Acute Summary Score at Week 12: Physical Component Summary|SF-36v2 health survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains were also summarized as physical and mental component summary scores. Physical component summary: the minimum score is 0 and the maximum score is 100. Higher scores indicates a better health state.|Baseline, Week 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2531259|NCT03349060|Secondary|Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12|Peds-FACIT-F is a 13-item questionnaire for adolescents of 12-17 years of age. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Higher the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the Peds-FACIT-F score for a total possible score of 0 (worse score) to 52 (the best score) where higher scores indicated better overall health status (less fatigue).|Baseline, Week 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2531260|NCT03349060|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) at Week 12|FACIT-F is a 13-item questionnaire. Participants (aged above 17 years) scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Higher the participant's response to the questions (with the exception of 2 negatively stated) greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (the best score) where higher scores indicated better overall health status (less fatigue).|Baseline, Week 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2531261|NCT03349060|Secondary|Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Visual Analogue Scale Score at Week 2, 4, 8 and 12|EQ-5D-Y is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score specifically developed and validated for use by youths age 12-17 years. EQ-5D-Y consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.|Baseline, Week 2, 4, 8, 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2531262|NCT03349060|Secondary|Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y): Index Value at Week 2, 4, 8 and 12|"EQ-5D-Y: standardized participant (aged 12-17 years) completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded no problems for each 5 dimensions, then health state was coded as 11111 with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. UK value sets (with all possible health states) was used for adolescents in the study, range from 1 to -0.594. Higher (positive) scores = better health state."|Baseline, Week 2, 4, 8, 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2531263|NCT03349060|Secondary|Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L)- Visual Analogue Scale Score at Week 2, 4, 8 and 12|EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's (aged above 17 years) rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.|Baseline, Week 2, 4, 8, 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2531264|NCT03349060|Secondary|Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L): Index Value at Week 2, 4, 8 and 12|"EQ-5D-5L: standardized participant (aged >17 years) completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded no problems for each 5 dimensions, then health state was coded as 11111 with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state."|Baseline, Week 2, 4, 8, 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2531265|NCT03349060|Secondary|Percentage of Participants Achieving 'Clear' or 'Almost Clear' and >=2 Points Improvement From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12|"Participant responded to Overall, how would you describe your Atopic Dermatitis right now? on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity."|Baseline, Week 2, 4, 8, 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure and “Number Analyzed” signifies the number of participants evaluable for the specified time points."|||percentage of participants|||Number
2531266|NCT03349060|Secondary|Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8 and 12|"Participant responded to Overall, how would you describe your Atopic Dermatitis right now? on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity."|Baseline, Week 2, 4, 8, 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2531267|NCT03349060|Secondary|Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 8 and 12|"POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as no days (0), 1-2 days (1), 3-4 days (2), 5-6 days (3) and every day (4). The score ranges from 0 to 28, where higher score indicated greater severity."|Baseline, Week 2, 4, 8, 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2531268|NCT03349060|Secondary|Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12|HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.|Baseline, Week 2, 4, 8, 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, Overall Number of Participants Analyzed” participants evaluable for this outcome measure."|||percentage of participants|||Number
2531269|NCT03349060|Secondary|Percentage of Participants With >=11 Points at Baseline and Achieving Score of <11 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12|HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.|Baseline, Week 2, 4, 8, 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure and Number Analyzed” signifies number of participants evaluable at the specified time points."|||percentage of participants|||Number
2531270|NCT03349060|Secondary|Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Depression Subscale at Week 2, 4, 8 and 12|HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.|Baseline, Week 2, 4, 8, 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure and Number Analyzed” signifies number of participants evaluable at the specified time points."|||percentage of participants|||Number
2531271|NCT03349060|Secondary|Percentage of Participants With >=8 Points at Baseline and Achieving Score of <8 Points in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12|HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.|Baseline, Week 2, 4, 8, 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure and Number Analyzed” signifies number of participants evaluable at the specified time points."|||percentage of participants|||Number
2531272|NCT03349060|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale: Anxiety Subscale at Week 2, 4, 8 and 12|HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety.|Baseline, Week 2, 4, 8, 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2547119|NCT02912195|Secondary|Pain Score (NRS 0-10)|Pain score recorded on the numeric rating scale 0-10.|At 50 minutes||||units on a scale||95% Confidence Interval|Mean
2531273|NCT03349060|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS): Depression Subscale at Week 2, 4, 8 and 12|HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D), both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms.|Baseline, Week 2, 4, 8, 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2531274|NCT03349060|Secondary|Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2.5 and Achieving >=2.5 Point Improvement From Baseline in CDLQI Score at Week 2, 4, 8 and 12|CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.|Baseline, Week 2, 4, 8, 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure and Number Analyzed” signifies number of participants evaluable at the specified time points."|||percentage of participants|||Number
2531275|NCT03349060|Secondary|Percentage of Participants With Baseline Dermatology Life Quality Index Score >=4 and Achieving >=4 Point Improvement From Baseline in DLQI Score at Week 2, 4, 8 and 12|DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.|Baseline, Week 2, 4, 8, 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participant who were evaluable for this measure and Number Analyzed” signifies number of participants evaluable at specified time points."|||percentage of participants|||Number
2531276|NCT03349060|Secondary|Percentage of Participants With Baseline Children's Dermatology Life Quality Index Score >=2 and Achieving <2 CDLQI Score at Week 2, 4, 8 and 12|CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.|Baseline, Week 2, 4, 8, 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure and Number Analyzed” signifies number of participants evaluable at specified time points."|||percentage of participants|||Number
2531277|NCT03349060|Secondary|Percentage of Participants With Baseline Dermatology Life Quality Index Score >=2 and Achieving <2 DLQI Score at Week 2, 4, 8 and 12|DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.|Baseline, Week 2, 4, 8, 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure and Number Analyzed” signifies number of participants evaluable at specified time points."|||percentage of participants|||Number
2531278|NCT03349060|Secondary|Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 2, 4, 8 and 12|CDLQI is a 10-item questionnaire that measures the impact of skin disease on adolescents (aged 12-17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.|Baseline, Week 2, 4, 8, 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2531279|NCT03349060|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 4, 8 and 12|DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's (aged above 17 years) quality of life over the last week. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.|Baseline, Week 2, 4, 8, 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2531305|NCT03348904|Secondary|Duration of Response (DOR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)|Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.|Approximately 25 months|All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted.||||||
2531280|NCT03349060|Secondary|Percentage of Participants Achieving >=1 Point Improvement From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis at Week 2, 4, 8 and 12|PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.|Baseline, Week 2, 4, 8, 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure and Number Analyzed” signifies number of participants evaluable at the specified time points."|||percentage of participants|||Number
2531281|NCT03349060|Secondary|Change From Baseline in Scoring Atopic Dermatitis: Total Score at Week 2, 4, 8 and 12|"SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where 0 = no itch or no sleeplessness and 10 = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome."|Baseline, Week 2, 4, 8, 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2531282|NCT03349060|Secondary|Change From Baseline in Scoring Atopic Dermatitis: Visual Analogue Scale of Sleep Loss at Week 2, 4, 8 and 12|"SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where 0 = no itch or no sleeplessness and 10 = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome."|Baseline, Week 2, 4, 8, 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2531283|NCT03349060|Secondary|Percentage of Participants With Scoring Atopic Dermatitis Response of >=75% Improvement From Baseline at Week 2, 4, 8 and 12|"SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none (0), mild (1), moderate (2) or severe (3). The severity scores added to give B (0-18). Subjective symptoms (C): pruritus and sleep loss, each of these 2 were scored by participant/caregiver using VAS where 0 = no itch or no sleeplessness and 10 = the worst imaginable itch or sleeplessness, higher scores worse symptoms. Scores for itch and sleeplessness added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD = worse outcome."|Baseline, Week 2, 4, 8, 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure and Number Analyzed” signifies number of participants evaluable at the specified time points."|||percentage of participants|||Number
2531284|NCT03349060|Secondary|Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12|"SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where 0 = no itch/no sleeplessness and 10 = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome."|Baseline, Week 2, 4, 8, 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure and “Number Analyzed” signifies number of participants evaluable at the specified time points."|||percentage of participants|||Number
2531307|NCT03348904|Primary|Progression-free Survival (PFS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)|Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review, or death due to any cause, whichever occurs first.|Approximately 25 months|All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted.||||||
2531285|NCT03349060|Secondary|Percentage of Participants With Percentage Body Surface Area Less Than (<) 5% at Week 2, 4, 8 and 12|4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limb, 3.33% for trunk and 2.5% for lower limb. % BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.|Week 2, 4, 8, 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, Number Analyzed” signifies number of participants evaluable at the specified time points."|||percentage of participants|||Number
2531286|NCT03349060|Secondary|Change From Baseline in Percentage Body Surface Area at Week 2, 4, 8 and 12|4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.|Baseline, Week 2, 4, 8, 12|Full analysis set included all randomized participants who received at least 1 dose of study medication.|||Percentage BSA||95% Confidence Interval|Least Squares Mean
2531287|NCT03349060|Secondary|Change From Baseline in Eczema Area and Severity Index Total Score at Week 2, 4, 8 and 12|EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.|Baseline, Week 2, 4, 8, 12|Full analysis set included all randomized participants who received at least 1 dose of study medication.|||units on a scale||95% Confidence Interval|Least Squares Mean
2531288|NCT03349060|Secondary|Percentage of Participants Achieving Eczema Area and Severity Index Response of 100% Improvement From Baseline at Week 2, 4, 8 and 12|EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.|Baseline, Week 2, 4, 8, 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, Number Analyzed” signifies number of participants evaluable at specified time points."|||percentage of participants|||Number
2531289|NCT03349060|Secondary|Percentage of Participants Achieving Eczema Area and Severity Index Response of >=90% Improvement From Baseline at Week 2, 4, 8 and 12|EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.|Baseline, Week 2, 4, 8, 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, Number Analyzed” signifies number of participants evaluable at the specified time points."|||percentage of participants|||Number
2531306|NCT03348904|Secondary|Objective Response Rate (ORR) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)|Defined as the proportion of participants who achieve a confirmed best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by blinded independent central review.|Approximately 25 months|All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted.||||||
2531308|NCT03348904|Primary|Overall Survival (OS) of Nivolumab Plus Epacadostat in Combination With Chemotherapy (Arm A) Compared to Chemotherapy (Arm B)|Defined as the time from randomization to the date of death from any cause.|Approximately 38 months|All randomized participants; Arm A did not enroll any participants in the study and as a result no comparisons were performed and since the study was terminated early no efficacy analyses were conducted.||||||
2531290|NCT03349060|Secondary|Percentage of Participants Achieving Eczema Area and Severity Index Response of >=50% Improvement From Baseline at Week 2, 4, 8 and 12|EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.|Baseline, Week 2, 4, 8, 12|"Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, Number Analyzed” signifies number of participants evaluable at the specified time points."|||percentage of participants|||Number
2531291|NCT03349060|Secondary|Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) at Week 2, 4, 8 and 12|IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.|Week 2, 4, 8, 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Number Analyzed” signifies number of participants evaluable at the specified time points.|||percentage of participants|||Number
2531292|NCT03349060|Secondary|Percentage of Participants Achieving Investigator's Global Assessment Response of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 2, 4 and 8|IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.|Baseline, Week 2, 4, 8|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure and “Number Analyzed” signifies the number of participants evaluable for the specified time points.|||percentage of participants|||Number
2531293|NCT03349060|Secondary|Percentage of Participants Achieving Eczema Area and Severity Index Response of >=75% Improvement From Baseline at Week 2, 4 and 8|EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.|Baseline, Week 2, 4, 8|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure and “Number Analyzed” signifies the number of participants evaluable for the specified time points.|||percentage of participants|||Number
2531294|NCT03349060|Secondary|Time to Achieve >=4 Points Improvement From Baseline in Numerical Rating Scale for Severity of Pruritus|Participants were asked to assess their worst itching/pruritus due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst itch imaginable), where higher scores indicated greater severity. 95% CI was based on the Brookmeyer and Crowley method.|Baseline up to Week 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||days||95% Confidence Interval|Median
2531295|NCT03349060|Secondary|Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis Total Score at Week 12: Per Protocol Analysis Set|PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.|Baseline, Week 12|Per-protocol analysis set included all randomized participants who received at least 1 dose of study medication and who had no major protocol violations. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2531595|NCT03334812|Secondary|Number of Participants With Anti-LNA043 Antibodies in Serum|Potential immunogenicity of LNA043|Baseline, Week 1, Week 4, Week 12 and Week 28|Safety Analysis Set|||Participants|||Count of Participants
2531296|NCT03349060|Secondary|Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score at Week 2, 4, 8 and 12: Full Analysis Set|PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition.|Baseline, Week 2, 4, 8, 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2531297|NCT03349060|Secondary|Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale for Severity of Pruritus at Week 2, 4 and 12: Per Protocol Analysis Set (PPAS)|Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.|Baseline, Week 2, 4, 12|Per-protocol analysis set included all randomized participants who received at least 1 dose of study medication and who had no major protocol violations. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||percentage of participants|||Number
2531298|NCT03349060|Secondary|Percentage of Participants With at Least 4 Points Improvement From Baseline in the Numerical Rating Scale (NRS) for Severity of Pruritus at Week 2, 4, 8 and 12: Full Analysis Set (FAS)|Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity.|Baseline, Week 2, 4, 8, 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||percentage of participants|||Number
2531299|NCT03349060|Primary|Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response of >=75 Percent (%) Improvement From Baseline at Week 12|EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.|Baseline, Week 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||percentage of participants|||Number
2531300|NCT03349060|Primary|Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to 2 Points Improvement From Baseline at Week 12|IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp.|Baseline, Week 12|Full analysis set included all randomized participants who received at least 1 dose of study medication. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure.|||percentage of participants|||Number
2531301|NCT03348904|Secondary|Estimate of DOR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)|Defined as the time between the date of first confirmed response and the date of the first documented tumor progression (per RECIST v1.1) assessed by blinded independent central review or death due to any cause, whichever occurs first.|Approximately 25 months|All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted.||||||
2531302|NCT03348904|Secondary|Estimate of ORR of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)|Defined as the proportion of participants who achieve a confirmed best response of CR or PR per RECIST v1.1 criteria as assessed by blinded independent central review.|Approximately 25 months|All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted.||||||
2531303|NCT03348904|Secondary|Estimate of PFS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)|Defined as the time between the date of randomization and the first date of documented progression assessed by blinded independent central review or death due to any cause, whichever occurs first.|Approximately 25 months|All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted.||||||
2531304|NCT03348904|Secondary|Estimate of OS of Nivolumab and Placebo in Combination With Chemotherapy (Arm C)|Defined as the time from randomization to the date of death from any cause.|Approximately 38 months|All randomized participants; Arm C did not enroll any participants in the study and as a result no analyses were performed and since the study was terminated early no efficacy analyses were conducted.||||||
2547120|NCT02912195|Secondary|Pain Score (NRS 0-10)|Pain score recorded on the numeric rating scale 0-10.|At 40 minutes||||units on a scale||95% Confidence Interval|Mean
2531309|NCT03348683|Secondary|Number of Neonates With Hypoglycemia|"Neonatal outcome - Number of neonates with hypoglycemia (blood glucose <50).~This population includes only the neonates who had heelsticks to check their blood glucose, which is not a universal practice and was not required by the protocol or IRB. The neonates included were those who met the nursery's risk-based protocol to check blood glucose after birth (ex: infants of diabetic mothers, fetal growth restriction, macrosomia, or symptoms suggestive of hypoglycemia)"|Day 1|This population includes the neonates who had heelsticks to check their blood glucose.|||Participants|||Count of Participants
2531310|NCT03348683|Secondary|Number of Neonates With Neonatal Outcome Composite Score = 1|"Composite neonatal outcome score was for any of the following morbidity: Neonatal Intensive Care Unit (NICU) admission, respiratory support (CPAP, nasal cannula, intubation), culture proven sepsis, radiographically proven intracranial hemorrhage, necrotizing enterocolitis, hypoglycemia (for those infants who had sugar checked), and neonatal death.~The composite score was computed as a score of 1 for any indication of neonatal morbidity - neonates who experienced at least one morbidity and the components are given equal weights. Patients who had no evidence of the predefined neonatal morbidities are subsequently given a score of 0. The minimum is 0 and maximum is 1."|Day 1||||Participants|||Count of Participants
2531311|NCT03348683|Secondary|Number of Fetus With Fetal Bradycardia|Count of fetus with fetal bradycardia (<110bpm for >10 minutes within 30 minutes of study drug administration)|30 minutes from drug administration||||Participants|||Count of Participants
2531312|NCT03348683|Secondary|Number of Fetus With Heart Rate Decelerations|Count of fetus with fetal heart rate decelerations within 30 minutes of study drug administration|30 minutes from drug administration||||Participants|||Count of Participants
2531313|NCT03348683|Secondary|Number of Participants With Postpartum Hemorrhage|Greater than 500cc of blood expelled during a vaginal delivery or greater than 1000cc of blood expelled during a cesarean section|30 minutes from drug administration||||Participants|||Count of Participants
2531314|NCT03348683|Secondary|Number of Participants With Maternal Morbidity Composite Score = 1|"Composite maternal morbidity score consists of a count of postpartum hemorrhage, transfusion, hysterectomy, placental abruption, chorioamnionitis, shoulder dystocia, episiotomy, higher order laceration, and ICU admission.~The composite score was computed as a score of 1 for any indication of maternal morbidity, that is the participant experienced at least one maternal morbidity, and the components are given equal weights. Participants who had no evidence of the predefined maternal morbidities are subsequently given a score of 0. The minimum is 0 and maximum is 1."|average of 24 hours||||Participants|||Count of Participants
2531315|NCT03348683|Secondary|Duration of Latent|Time of latent labor defined as <6cm of cervical dilation.|average of 24 hours||||hours||Standard Deviation|Mean
2531316|NCT03348683|Secondary|Number of Participants With Various Mode of Delivery|Number of various mode of delivery - count of Vaginal delivery, vacuum assisted vaginal delivery, forceps assisted vaginal delivery, cesarean section|average of 24 hours||||Participants|||Count of Participants
2531317|NCT03348683|Primary|Time From Beginning of Induction to Delivery|The time of induction (based on time of foley balloon placement for cervical ripening or misoprostol administration) to the time of delivery of the infant.|average of 24 hours|N=154 - only those who delivered vaginally|||hours||Standard Deviation|Mean
2531318|NCT03346902|Primary|Assessment of Visual Analog Scale (VAS) Change (Values From 0 (Worst) to 10 (Best))|Assessment of change in Visual Analog Scale score (values from 0 (worst) to 10 (best)) from day of surgery to Day 30. Percentage of subjects reporting an improvement in Visual Analog Scale score.|Day 30|mITT|||Percentage reporting improvement|||Number
2531319|NCT03346850|Secondary|Number of Participants Who Were Readmitted to the Hospital||30 days after discharge from initial hospital visit|2 in the NGT arm were lost to follow up, and 3 in the NDT arm were lost to follow up; therefore, this data was not collected for these 5 participants.|||Participants|||Count of Participants
2531320|NCT03346850|Secondary|Number of Participants Who Were Readmitted to the Hospital||7 days after discharge from initial hospital visit|2 in the NGT arm were lost to follow up, and 3 in the NDT arm were lost to follow up; therefore, this data was not collected for these 5 participants.|||Participants|||Count of Participants
2531321|NCT03346850|Secondary|Number of Participants Who Revisited the Emergency Room (ER)||30 days after discharge from hospital|2 in the NGT arm were lost to follow up, and 3 in the NDT arm were lost to follow up; therefore, this data was not collected for these participants.|||Participants|||Count of Participants
2531322|NCT03346850|Secondary|Number of Participants Who Revisited the Emergency Room (ER)||7 days after discharge from hospital|2 in the NGT arm were lost to follow up, and 3 in the NDT arm were lost to follow up; therefore, this data was not collected for these participants.|||Participants|||Count of Participants
2531323|NCT03346850|Secondary|Number of Chest X-rays Obtained Among All Participants||from the time of hospital admission to discharge (about 6 days)||||chest x-rays|||Number
2531324|NCT03346850|Secondary|Peak Respiratory Support in Liters Per Minute||from the time of hospital admission to discharge (about 6 days)||||liters per minute||Standard Deviation|Mean
2531325|NCT03346850|Secondary|Number of Participants With Emesis||from the time of hospital admission to discharge (about 6 days)||||Participants|||Count of Participants
2531326|NCT03346850|Primary|Length of Respiratory Supprt||from the time of hospital admission to discharge (about 6 days)||||hours||Standard Deviation|Mean
2531327|NCT03346759|Secondary|Change in Relative Abundance of Gardnerella Vaginalis|The differences in relative abundance of Gardnerella vaginalis between: the last swab collected during menstrual cycle 1 and the first swab collected, the last swab collected during menstrual cycle 2 and the first swab collected, and the last swab collected during menstrual cycle 3 and the first swab collected. Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. Thus, a relative abundance of Gardnerella vaginalis equal to 0.9 would mean that 90% of the bacteria identified in a sample are Gardnerella vaginalis.|Baseline, end of first menstrual cycle (approximately 6 weeks), end of second menstrual cycle (approximately 10 weeks), and end of third menstrual cycle (approximately 14 weeks)|Participants analyzed are those that provided samples through the end of the given menstrual cycle.|||relative abundance||Inter-Quartile Range|Median
2531596|NCT03334812|Secondary|PK Profile of LNA043 and of AngPTL3 in Serum AUC|Local and systemic pharmacokinetics (PK) of LNA043 following a single i.a. administration|4 weeks|Pharmacokinetic Analysis Set|||hr*ng/mL||Standard Deviation|Mean
2531328|NCT03346759|Primary|Change in Relative Abundance of Lactobacillus Species|The differences in relative abundance of Lactobacillus species between: the last swab collected during menstrual cycle 1 and the first swab collected, the last swab collected during menstrual cycle 2 and the first swab collected, and the last swab collected during menstrual cycle 3 and the first swab collected. Relative abundance is defined as the proportion of total identified bacteria in a sample that are a given type of bacteria. The Lactobacillus species included here are L. crispatus, L. iners, L. gasseri, and L. jensenii. Thus, a relative abundance of Lactobacillus species equal to 0.9 would mean that 90% of the bacteria identified in a sample are Lactobacillus species.|Baseline, end of first menstrual cycle (approximately 6 weeks), end of second menstrual cycle (approximately 10 weeks), and end of third menstrual cycle (approximately 14 weeks)|Participants analyzed are those that provided samples through the end of the given menstrual cycle.|||relative abundance||Inter-Quartile Range|Median
2531329|NCT03346161|Secondary|Usability as Measured by the Computer System Usability Questionnaire (CSUQ)|"Assessed ease of usability of the BREASTChoice tool~Scale is from 1 (strongly disagree) to 7 (strongly agree)"|Through completion of breast consultation appointment (total participant time approximately 30 minutes)|-Only patients randomized to BREASTChoice (Decision Tool) are evaluable for this outcome measure|||score on a scale||Full Range|Mean
2531330|NCT03346161|Secondary|Consult Time|Assessed the time between when the plastic/reconstructive surgeon entered and exited the consult room (not including time spent with a resident, nurse, or other clinical staff)|Through completion of breast consultation appointment (total participant time approximately 30 minutes)||||minutes||Full Range|Mean
2531331|NCT03346161|Secondary|Time Spent on Tool|How long participants spent on the BREASTChoice tool|Through completion of breast consultation appointment (total participant time approximately 30 minutes)|-Only patients randomized to BREASTChoice (Decision Tool) are evaluable for this outcome measure|||minutes||Full Range|Median
2531332|NCT03346161|Secondary|Timing of Reconstruction|"Assessed timing of reconstruction~Immediate is defined as reconstruction at the time of mastectomy~Delayed is defined as reconstruction any time after the mastectomy and performed as a separate surgery"|Through completion of follow-up (approximately 6 months)|Only patients who had reconstruction are applicable for this outcome measure|||Participants|||Count of Participants
2531333|NCT03346161|Secondary|Type of Reconstruction|Assessed what type of reconstruction participants received|Through completion of follow-up (approximately 6 months)|Only patients who had reconstruction are applicable for this outcome measure|||Participants|||Count of Participants
2531334|NCT03346161|Secondary|Receipt of Reconstruction|Assessed if participants received reconstruction|Through follow-up (approximately 6 months)|2 participants in the Enhanced Usual Care arm have not had their reconstruction surgery but are planning to schedule it but it is outside the follow-up window.|||Participants|||Count of Participants
2531335|NCT03346161|Secondary|Patient Activation (PAM) as Measured by the Number of Participants Who Agreed With Each Statement|"-3 questions consisting of the following:~I am confident I can tell my healthcare provider concerns that I have about breast reconstruction even when he or she does not ask (confidence in healthcare provider)~I am confident I can find trustworthy sources of information about my breast reconstruction decision (confidence in trustworthy sources)~I know the different options available for breast reconstruction (knowledge on breast reconstruction options)"|Through completion of breast consultation appointment (total participant time approximately 30 minutes)|3 participants in the BREASTChoice arm did not provide an answer to this question and are not evaluable for this outcome measure.|||Participants|||Count of Participants
2531336|NCT03346161|Secondary|Gold Standard Shared Decision Making as Measured by the Top collaboRATE Score|"Top collaboRATE score = the percentage of patients from whom there was 'gold standard' shared decision making as assessed by the collaboRATE measure~The top score is coded as '1', if the response to all three collaboRATE items was less than 9. Then the investigators calculated the percentage of all encounters that were coded as '1' indicating gold standard shared decision making."|Through completion of breast consultation appointment (total participant time approximately 30 minutes)|3 participants from Arm 1 were excluded from the outcome measure as their data was missing. 1 participants from Arm 2 was excluded from the outcome measure as her data was missing.|||Participants|||Count of Participants
2531337|NCT03346161|Secondary|Quality of Life as Measured by the BREAST-Q Questionnaire|"Assessed 4 subscales: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being~Score from 0 (worst) to 100 (best). Higher scores reflect a better outcome."|Through completion of breast consultation appointment (total participant time approximately 30 minutes)||||score on a scale||Standard Deviation|Mean
2531338|NCT03346161|Primary|Decision Process (Decision Quality Index Subscale)|"The total points are summed and then divided by the total number of items to result in scores from 0-100%, with higher scores indicating a more shared decision making process~Assess the extent to which patients were meaningfully involved in decision-making with their clinicians"|Through completion of breast consultation appointment (total participant time approximately 30 minutes)||||score on a scale||Standard Deviation|Mean
2531339|NCT03346161|Primary|Decisional Conflict (SURE Measure)|"To determine whether the CDT reduces uncertainty about choice. Participants are asked to report how sure they feel about their choice, if they have enough information to understand the choice, if they are clear about the risks and benefits, and if they have enough support to make a choice. Results are compared between the BREASTChoice and Enhanced Usual Care groups.~Higher SURE values indicate certainty in choice~Scores range from 0-4"|Through completion of breast consultation appointment (total participant time approximately 30 minutes)||||score on a scale||Standard Deviation|Mean
2531340|NCT03346161|Primary|Percent Correct on the Knowledge Measure (Objective Knowledge Score)|To determine whether the CDT increases knowledge about their choice, the investigators will compare objective knowledge scores between participants using the CDT and those who received usual care|Through completion of breast consultation appointment (total participant time approximately 30 minutes)||||percentage of answers correct||Standard Deviation|Mean
2531359|NCT03345407|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|A single 12-lead ECG with a 15-second rhythm strip was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and corrected QT (QTc) intervals. Abnormal ECG findings are presented.|Screening, Days 14, 84, 112 and at early withdrawal|Safety Population.|||Participants|||Count of Participants
2531341|NCT03346070|Secondary|Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.7: Geometric Mean Analysis|The efficacy analysis of TTR of participant TOF ratio to ≥0.7 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.7 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).|Up to 61 minutes|All randomized participants dosed with both an NMBA and an NMB reversal agent (study treatment) with ≥1 post-randomization efficacy assessment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.|||Minutes||95% Confidence Interval|Geometric Mean
2531342|NCT03346070|Secondary|Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.8: Geometric Mean Analysis|The efficacy analysis of TTR of participant TOF ratio to ≥0.8 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.8 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).|Up to 69 minutes|All randomized participants dosed with both an NMBA and an NMB reversal agent (study treatment) with ≥1 post-randomization efficacy assessment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.|||Minutes||95% Confidence Interval|Geometric Mean
2531343|NCT03346070|Secondary|Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.9: Secondary Geometric Mean Analysis|The secondary efficacy analysis of TTR of participant TOF ratio to ≥0.9 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).|Up to 76 minutes|All randomized participants dosed with both an NMBA and an NMB reversal agent (study treatment) with ≥1 post-randomization efficacy assessment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.|||Minutes||95% Confidence Interval|Geometric Mean
2531344|NCT03346070|Secondary|Percentage of Participants With Prolonged (>10 Minutes) Time to Recovery (TTR) of the Train Of Four (TOF) Ratio to ≥0.9|Following administration of study intervention, the percentage of participants experiencing prolonged (>10 minutes) recovery to a TOF ratio ≥0.9 was calculated. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).|Up to 76 minutes|All randomized participants dosed with both an NMBA and an NMB reversal agent (study treatment) with ≥1 post-randomization efficacy assessment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.|||Percentage of participants|||Number
2531345|NCT03346070|Primary|Percentage of Participants Experiencing an Event of Clinical Interest (ECI) After Administration of Study Intervention|The percentage of participants experiencing an ECI following administration of study intervention was monitored. ECIs are a discrete set of both AEs and SAEs, specifically designated as such for the trial. For the purposes of this investigation, ECIs included 1) drug-induced liver injury; 2) clinically-relevant arrhythmias, inclusive of bradycardia and tachycardia defined as events necessitating intervention, as determined by investigator judgment; and 3) instances of hypersensitivity and/or anaphylaxis adjudicated by an external expert Adjudication Committee. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).|Up to 7 days|All randomized participants who received at least one dose of study treatment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.|||Percentage of participants|||Number
2531400|NCT03344861|Secondary|Microscopic Tissue Examination: Number of Participants With Increased Alveolar Macrophages in the Normal Lung After Surgery|The number of participants with increased alveolar macrophages post surgery determined in the microscopic tissue examination.|Day 13 to 18||||Participants|||Count of Participants
2531346|NCT03346070|Primary|Percentage of Participants Experiencing a Serious Adverse Event (SAE) After Administration of Study Intervention|The percentage of participants experiencing an SAE following administration of study intervention was monitored. An SAE is an adverse event that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially requiring medical or surgical intervention. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).|Up to 7 days|All randomized participants who received at least one dose of study treatment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.|||Percentage of participants|||Number
2531347|NCT03346070|Primary|Percentage of Participants Experiencing an Adverse Event (AE) After Administration of Study Intervention|The percentage of participants experiencing an AE following administration of study intervention was monitored. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study treatment is also considered an AE. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).|Up to 7 days|All randomized participants who received at least one dose of study treatment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.|||Percentage of participants|||Number
2531348|NCT03346070|Primary|Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events|The percentage of participants experiencing other treatment-emergent cardiac arrhythmia events were identified with continuous ECG monitoring. Other treatment-emergent cardiac arrhythmias are defined as new or worsening arrhythmias (e.g., atrial fibrillation, atrial tachyarrhythmia, ventricular fibrillation, or ventricular tachyarrhythmia), sustained for at least 1 minute after administration of study intervention. Worsening arrhythmia events may or may not be considered an AE, as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).|Up to 35 minutes|All randomized participants who received at least one dose of study treatment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.|||Percentage of participants|||Number
2531349|NCT03346070|Primary|Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events|The percentage of participants experiencing treatment-emergent sinus tachycardia events were identified with continuous ECG monitoring. Treatment-emergent sinus tachycardia is defined as a heart rate ≥100 bpm that has also increased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus tachycardia events may or may not be considered an AE, as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).|Up to 35 minutes|All randomized participants who received at least one dose of study treatment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.|||Percentage of participants|||Number
2531350|NCT03346070|Primary|Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events|The percentage of participants experiencing treatment-emergent bradycardia events were identified with continuous electrocardiogram (ECG) monitoring. Treatment-emergent sinus bradycardia is defined as a heart rate <60 bpm that has also decreased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus bradycardia events may or may not be considered an adverse event (AE), as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).|Up to 35 minutes|All randomized participants who received at least one dose of study treatment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.|||Percentage of participants|||Number
2531360|NCT03345407|Secondary|Number of Participants With Worst Case Post Baseline Diastolic Blood Pressure (DBP), Systolic Blood Pressure (SBP) and Pulse Rate|"The DBP, SBP and pulse rate were measured with participants seated at least 5 minutes before the assessments. Participants are counted in the worst case category if their value changes to (low, within range or no change, or high). Participants whose value category was unchanged (e.g., High to High), or whose value became within range, are recorded in the To w/in Range or No Change category. Participants are counted twice if the participant has values that changed To Low and To High, so the percentages may not add to 100%. Participants with missing baseline value are assumed to have within range value."|Up to Week 16|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Participants|||Count of Participants
2531351|NCT03346070|Primary|Time to Recovery (TTR) of Participant Train Of Four (TOF) Ratio to ≥0.9: Primary Kaplan-Meier Analysis|The primary efficacy analysis of TTR of TOF ratio to ≥0.9 was performed by estimating event rates within each treatment group using the Kaplan-Meier method. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW).|Up to 76 minutes|All randomized participants dosed with both an NMBA and an NMB reversal agent (study treatment) with ≥1 post-randomization efficacy assessment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB.|||Minutes||95% Confidence Interval|Median
2531352|NCT03345472|Secondary|Leg Pain Efficacy Responder Rate|"Characterize the leg pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in leg pain, as measured by the Visual Analog Scale (VAS).~The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder.~The percentage of subjects who experience at least a 50% improvement in leg pain can range from 0% (no responders) to 100% (all responders)."|Baseline to 3 months||||percent of subjects who are responders||95% Confidence Interval|Number
2531353|NCT03345472|Secondary|Low Back Pain Efficacy Responder Rate|"Characterize the low back pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in low back pain, as measured by the Visual Analog Scale (VAS).~The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder.~The percentage of subjects who experience at least a 50% improvement in low back pain can range from 0% (no responders) to 100% (all responders)."|Baseline to 3 months||||percent of subjects who are responders||95% Confidence Interval|Number
2531354|NCT03345472|Secondary|Overall Pain Efficacy Responder Rate|"Characterize the overall pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in overall pain, as measured by the Visual Analog Scale (VAS).~The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder.~The percentage of subjects who experience at least a 50% improvement in overall pain can range from 0% (no responders) to 100% (all responders)."|Baseline to 3 months||||percent of subjects who are responder||95% Confidence Interval|Number
2531355|NCT03345472|Primary|Change in Overall Pain Intensity on the Visual Analog Scale (0-100)|"Demonstrate a significant improvement in overall pain intensity as measured by the Visual Analog Scale (VAS).~The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The change in overall pain intensity is calculated as the Baseline VAS minus the 3-month VAS, where a positive value indicates an improvement (ie, reduction) in pain from Baseline to 3 months. Higher values represent a larger reduction (ie, greater improvement) in pain.~The change in overall pain intensity as measured by the VAS can range from -100 (worsening in pain from 0 at baseline to 100 at 3 months) to 100 (improvement in pain from 100 at baseline to 0 at 3 months). It should be noted that while the change in VAS can range from -100 to 100, no subjects had a VAS of 0 at baseline, as the presence of pain was required for eligibility for inclusion in the study."|Baseline to 3 months||||units on a scale||Standard Error|Mean
2531356|NCT03345407|Secondary|Number of Participants Reporting COPD Exacerbations|Participants reporting acute COPD exacerbations during the study period has been presented.|Up to Week 16|Safety Population.|||Participants|||Count of Participants
2531357|NCT03345407|Secondary|Number of Participants With Worst Case Post Baseline Hematology Values|"Blood samples were collected for the analysis of hematology parameters including: platelets (Pla), red blood cells count, Hemoglobin (Hb), Hematocrit, mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), percentage reticulocytes, neutrophils (Neu), lymphocytes (Lym), monocytes, eosinophils, leukocytes (Leu) and basophils. Participants are counted in the worst case category if their value changes to (low, within range or no change, or high). Participants whose value category was unchanged (e.g., High to High), or whose value became within range, are recorded in the To w/in Range or No Change category. Participants are counted twice if the participant has values that changed To Low and To High, so the percentages may not add to 100%. Participants with missing baseline value are assumed to have within range value."|Upto Week 16|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2531358|NCT03345407|Secondary|Number of Participants With Worst Case Post Baseline Clinical Chemistry Values|"Blood samples were collected for the analysis of clinical chemistry parameters including: blood urea nitrogen (BUN), creatinine (Crt), glucose (Glu), potassium (Pot), sodium (Sod), calcium (Cal), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total and direct bilirubin, total protein and albumin (Alb). Participants are counted in the worst case category if their value changes to (low, within range or no change, or high). Participants whose value category was unchanged (e.g., High to High), or whose value became within range, are recorded in the To w/in Range or No Change category. Participants are counted twice if the participant has values that changed To Low and To High, so the percentages may not add to 100%. Participants with missing baseline value are assumed to have within range value."|Upto Week 16|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2531361|NCT03345407|Secondary|Number of Participants Reporting Non-serious Adverse Events (Non-SAEs), SAEs and AE of Special Interest (AESI)|An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect and other important medical events. Safety Population consists of all randomized participants who received at least one dose of study treatment. Participants were summarized according to treatment that they actually received.|Up to Week 24|Safety Population.|||Participants|||Count of Participants
2531362|NCT03345407|Other Pre-specified|Plasma Drug Concentration at Pre-dose (Ctrough) of Nemiralisib|Plasma samples were collected at indicated time points and analyzed.|Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28|PK Population.|||Picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2531363|NCT03345407|Other Pre-specified|Time to Reach Cmax (Tmax) of Nemiralisib|Plasma samples were collected at indicated time points and analyzed.|Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28|PK Population.|||Hours||Full Range|Median
2531364|NCT03345407|Other Pre-specified|Maximum Observed Plasma Drug Concentration (Cmax) of Nemiralisib|Plasma samples were collected at indicated time points and analyzed.|Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28|PK Population.|||Picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2531365|NCT03345407|Other Pre-specified|AUC From Time Zero to Time 't' [AUC(0-t)] of Nemiralisib|Plasma samples were collected at indicated time points and analyzed.|Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28|PK Population.|||Hours*picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2531366|NCT03345407|Other Pre-specified|Area Under the Concentration Time Curve (AUC) From Time Zero to 24 Hours [AUC(0-24)] of Nemiralisib|Plasma samples were collected at indicated time points and analyzed.|Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28|PK Population.|||Hours*picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2531367|NCT03345407|Secondary|Plasma Concentration of Nemiralisib|Plasma samples were collected at indicated time points and analyzed for concentrations of Nemiralisb. Pharmacokinetic (PK) Population consists of all participants in the Safety population who had at least 1 non-missing PK assessment (Non-quantifiable [NQ] values will be considered as non-missing values). Participants were summarized according to the treatment that they actually received.|Pre-dose, 0-1 hour, >1-6 hours post-dose on Days 14 and 28|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2531368|NCT03345407|Secondary|Percentage of Rescue-free Days|Albuterol (Salbutamol) MDI or nebules was used as a rescue medication. Percentage of Rescue-Free Days is defined as sum of the number of days where the number of occasions of rescue medication use is zero within the time-period divided by total number of days with non-missing values within the time-period multiplied by 100 where the time-period is defined as follows: Week 1: Day 1-7; Week 2: Day 8 - 14; Week 3: Day 15-21; Week 4: Day 22-28; Week 5: Day 29-35; Week 6: Day 36-42; Week 7: Day 43-49; Week 8: Day 50-56; Week 9: Day 57-63; Week 10: Day 64-70; Week 11: Day 71-77; Week 12: Day 78 to Day of last dose; Over the 12-Week: Day 1 to Day of last dose.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 of treatment and over the Week 12 treatment period|MITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percentage of rescue free days||Standard Deviation|Mean
2531369|NCT03345407|Secondary|Mean Number of Occasions of Rescue Medication Use Per Day|Albuterol (Salbutamol) MDI or nebules was used as a rescue medication. Rescue medication use was recorded as the number of occasions of rescue medication use each day. The mean number of occasions of rescue medication use per day is defined as sum of the number of occasions of rescue medication use each day within the time-period divided by the total number of days with non-missing values within the time-period. Over the 12-Week treatment period is defined as Day 1 to Day of last dose.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 of treatment and over the Week 12 treatment period|MITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||No. of occasions of rescue use per day||Standard Deviation|Mean
2531370|NCT03345407|Secondary|Change From Baseline in SGRQ Total Score at Days 28, 56 and 84|SGRQ-C is a 40-item questionnaire designed specifically to focus on COPD participants and was scored equivalent to SGRQ Total Score, ranging from 0 to 100, where higher scores reflect worse health-related quality of life. Scores on a scale were calculated as 100 multiplied by summed weights from positive items in questionnaire divided by sum of weights of all items in questionnaire. Baseline (Day 1) is defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in SGRQ Total Score is defined as SGRQ Total Score on Days 28, 56 and 84 minus Baseline SGRQ Total Score. Analysis was performed using Bayesian repeated measures model adjusting for Baseline by visit interaction, treatment by visit interaction, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in previous 12 months and gender. Posterior adjusted median change from Baseline and 95% HPD CrI was presented|Baseline and Days 28, 56 and 84|MITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||95% Confidence Interval|Median
2531371|NCT03345407|Secondary|Percentage of Responders on the St. George's Respiratory Questionnaire (SGRQ) Total Score as Measured by the SGRQ for COPD Participants (SGRQ-C) at Days 28, 56, and 84|SGRQ-C is a 40-item questionnaire designed specifically to focus on COPD participants and was scored equivalent to the SGRQ Total Score, ranging from 0 to 100, where higher scores reflect worse health-related quality of life. The percentage of responders on the SGRQ Total Score was derived for participants with a Baseline SGRQ Total Score >=4. Percentage of responders on the SGRQ Total Score is defined as number of participants with a decrease from Baseline in SGRQ Total Score >=4 on or before Days 28, 56 and 84 divided by total number of participants in the MITT population. Analysis was performed using a separate Bayesian logistic regression for each time point adjusting for treatment group, smoking status at baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in the previous 12 months and gender.|Days 28, 56 and 84|MITT Population.|||Percentage of responders|||Number
2531372|NCT03345407|Secondary|Change From Baseline in CAT Total Score|The CAT is a short, self-completed, 8-item questionnaire, each item was rated on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment). The total CAT score was calculated by summing the scores of all items and ranges from 0 to 40, higher scores indicating more severe condition. Baseline (Day 1) is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in CAT Total Score is defined as CAT Total Score on Days 28, 56 and 84 minus Baseline CAT Total Score. Analysis was performed using Bayesian repeated measures model adjusting for Baseline by visit interaction, treatment by visit interaction, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in the previous 12 months and gender. Posterior adjusted median change from Baseline and 95% HPD CrI has been presented.|Baseline and at Days 28, 56 and 84|MITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||95% Confidence Interval|Median
2531373|NCT03345407|Secondary|Percentage of Responders Using the COPD Assessment Test (CAT) on Treatment Days 28, 56, and 84, and Following EXACT Defined Recovery From the Index Exacerbation|The CAT is a short, self-completed, 8-item questionnaire, each item was rated on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment). The total CAT score is calculated by summing the scores of all items and ranges from 0 to 40, higher scores indicating severe condition. The percentage of responders using the CAT is defined as number of participants with a decrease from Baseline in CAT Total Score >=2 on or before Days 28, 56 and 84 divided by total number of participants in the MITT population. Percentage of responders using CAT was derived only for participants with a Baseline CAT Total Score >=2. Analysis was performed using a separate Bayesian logistic regression for each time point adjusting for treatment group, smoking status at baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in the previous 12 months and gender.|Days 28, 56 and 84|MITT Population.|||Percentage of responders|||Number
2531374|NCT03345407|Secondary|Mean Severity of Subsequent Health Care Resource Use (HCRU) Exacerbations Defined by EXACT|Severity of subsequent HCRU-defined exacerbations defined by EXACT was defined as the highest EXACT Total Score (not using the 3-day Rolling Average) during the period from date of onset of the subsequent HCRU-exacerbation until date of EXACT-defined recovery of subsequent exacerbation. EXACT-PRO, 14-item instrument to capture occurrence, frequency, severity, and duration of exacerbations using an eDiary. Total score ranges from 0-100, higher score indicates more severe condition. For participants with more than one subsequent exacerbation, severity was calculated for each subsequent exacerbation.|Up to Week 12|Severity was derived for participants from MITT Population who had reported subsequent exacerbation. Only those participants with data available at specified data points were analyzed (represented by n=X in the category title).|||Scores on a scale||Standard Deviation|Mean
2531375|NCT03345407|Secondary|Number of Participants With Time to Recovery From Index Exacerbation Using EXACT- PRO Tool|Time to EXACT-defined recovery from index exacerbation is defined as time from the date of randomization until date of the first EXACT-defined recovery day during the 12-Week Treatment Period. EXACT-defined recovery from the index exacerbation is defined as a decrease in the Rolling Average EXACT total Score >=9 points from the Maximum Observed Value, sustained for >=7 days, with the first of the 7 days defined as the recovery day. Analysis was performed using a Bayesian Cox proportional hazards model adjusting for treatment group, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in the previous 12 months and gender. Number of participants reporting events is presented.|From randomization to Week 12|MITT Population.|||Participants|||Count of Participants
2531376|NCT03345407|Secondary|Percentage of Participants Achieving the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Definition of Recovery From the Index Exacerbation|EXACT patient-reported outcome (EXACT-PRO), 14-item instrument to capture occurrence, frequency, severity, and duration of exacerbations using an electronic diary (eDiary). Total score ranges from 0-100, higher score indicates more severe condition. Participants were required to complete EXACT-PRO every evening; however, on the day of randomization it was to be completed in the morning. Response was decrease in rolling average EXACT Total Score >=9 points from maximum observed value, sustained for >=7 days, with first of 7 days defined as recovery day. Analysis was performed using Bayesian Cox proportional hazards model adjusting for treatment group, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in previous 12 months and gender.|Days 14, 28, 56 and 84|MITT Population.|||Percentage of participants|||Number
2531377|NCT03345407|Secondary|Change From Hospital Discharge in Clinic Visit Trough FEV1 Measured Pre and Post-bronchodilator|Pulmonary function was measured by FEV1, defined as maximal amount of air exhaled forcefully from the lungs in 1 second. Post-bronchodilator FEV1 was conducted approximately 10 to 30 minutes after participant was administered with 4 inhalations of albuterol via MDI using a spacer/valved-holding chamber or via 1 nebulized treatment. Pre-bronchodilator and post-bronchodilator Baseline FEV1 is defined as latest FEV1 measured prior to first dose of study treatment and pre-bronchodilator and post-bronchodilator, respectively. Change from hospital discharge in clinic visit trough FEV1 at Days 14, 28, 56 and 84 measured pre- and post-bronchodilator is defined as FEV1 measured prior to dosing and pre- and post-bronchodilator on Days 14, 28, 56 and 84 minus pre and post-bronchodilator Baseline FEV1.|Baseline and pre- and post-bronchodilator on Days 14, 28, 56 and 84|MITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Liters||Standard Deviation|Mean
2531378|NCT03345407|Secondary|Change From Baseline in Clinic Visit Trough FEV1 Measured Pre and Post-bronchodilator|Pulmonary function was measured by FEV1, defined as maximal amount of air exhaled forcefully from the lungs in 1 second. Post-bronchodilator FEV1 was conducted approximately 10-30 minutes after participant was administered with 4 inhalations of albuterol via MDI using a spacer/valved-holding chamber or via 1 nebulized treatment. Pre-bronchodilator and post-bronchodilator Baseline FEV1 is latest FEV1 measured prior to first dose of study treatment and pre-bronchodilator and post-bronchodilator, respectively. Change from Baseline in clinic visit trough FEV1 at Days 14, 28, 56 and 84 measured pre-bronchodilator is defined as FEV1 measured prior to dosing and pre-bronchodilator on Days 14, 28, 56 and 84 minus pre-bronchodilator Baseline FEV1.|Baseline and Days 14, 28, 56 (pre and post bronchodilaor), 84 (pre-bronchodilator) and at hospital discharge (maximum 24 Weeks)|MITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Liters||Standard Deviation|Mean
2531379|NCT03345407|Secondary|Number of Participants With Time to Next Moderate/Severe Exacerbation Following Index Exacerbation|Number of participants with time to next (on-treatment) moderate/severe exacerbation following index exacerbation during the 12-Week Treatment Period was defined as time from the date of randomization until the date of onset of the first moderate/severe exacerbation whilst on study treatment. Participants who did not have an exacerbation whilst on study treatment were censored at the date of their last dose of study treatment. Time to next exacerbation was analyzed using a Bayesian Cox proportional hazards model adjusting for treatment group, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in the previous 12 months and gender.|Up to Week 12|MITT Population.|||Participants|||Count of Participants
2531380|NCT03345407|Secondary|Rate of Moderate and Severe Exacerbations Over 12-week Treatment Period|Moderate COPD exacerbations are defined as worsening symptoms of COPD treated with short-acting bronchodilators (SABDs) plus antibiotics and/or oral/systemic corticosteroids. Severe COPD exacerbations are defined as worsening symptoms of COPD that require hospitalization or visit to the emergency room. Severe exacerbation may also be associated with acute respiratory failure. Rate of exacerbations was analyzed using Bayesian Poisson model adjusting for length of on-treatment follow-up, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in the previous 12 months and gender. Posterior median exacerbation rate and 95% HPD CrI has been presented.|Up to Week 12|MITT Population.|||No.of exacerbation per 84 Days||95% Confidence Interval|Median
2531381|NCT03345407|Primary|Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 84 Measured Post Bronchodilator|FEV1 is maximal amount of air exhaled forcefully from lungs in 1 second. Post-bronchodilator FEV1 was conducted approximately 10-30 minutes after participant was administered 4 inhalations of albuterol (salbutamol) via MDI using spacer/valved-holding chamber or via one nebulized treatment. Post-bronchodilator Baseline FEV1 is latest FEV1 measured prior to first dose of study treatment and post-bronchodilator. Change from Baseline in clinic visit trough FEV1 at Day 84 measured post-bronchodilator is FEV1 measured prior to dosing and post-bronchodilator on Day 84 minus post-bronchodilator Baseline FEV1. Bayesian repeated measure model adjusted for Baseline by visit interaction, treatment by visit interaction, smoking status at Baseline, region, severity of index exacerbation, number of moderate/severe exacerbations in previous 12 months and gender was used. Posterior adjusted median change from Baseline and 95% highest posterior density (HPD) credible interval (CrI) was presented.|Baseline and Day 84|MITT Population consisted of all randomized participants who received at least 1 dose of study treatment.. Only those participants with data available at the specified data points were analyzed.|||Liters||95% Confidence Interval|Median
2531382|NCT03345108|Primary|Mass of Peanuts Under Combined Maxillary and Mandibular Dentures (Denture Adhesive Applied Per Conventional Pattern)|Participants received 1.6 grams (g) of test adhesive on their dentures in a conventional pattern. After 60 minutes (min), participants were provided with 30-32 g non-salted peanuts, divided into smaller portions of approximately eight peanut halves. Each portion chewed for approximately 20 seconds (s). After consumption of all peanuts, participants had rinse their mouth with water for approximately 5 s. Dentures were removed and any peanuts remaining in the mouth were collected using a gauze. Both denture and gauze were placed in a beaker with hot de-ionized water and sonicated for 30 minutes (min) after which the water was strained through a standard testing sieve. The collected particles were washed and air-dried and transferred to pre-weighed aluminium weighing pans using a spatula and then, were dried in an oven at 40-degree Celsius for 5 hours. The pans were removed, cooled to room temperature and then weighed to determine the mass of the particles collected from each denture.|Upto 9 weeks|The primary endpoint has been measured for intent-to-treat (ITT) population (N=48). The ITT population included all randomized participants who received at least 1 dose of study treatment during the study and consumed peanuts and had at least 1 mass of peanuts from both upper and lower dentures.|||Grams||Standard Deviation|Mean
2531383|NCT03344861|Primary|Safety: Skin Photosensitivity Events Summaries of Abnormal Findings for Each Subject|Safety evaluation will include incidence of skin photosensitivity summarized for each subject.|108 days (to 3 months post surgery)||||Participants|||Count of Participants
2531384|NCT03344861|Primary|Safety: Laboratory Tests Summaries of Abnormal Findings for Each Subject|Safety evaluation will include laboratory tests summarized for each subject with any abnormal lab results considered an AE (adverse event) to be listed.|108 days (to 3 months post surgery)||||Participants|||Count of Participants
2531385|NCT03344861|Primary|Safety: Vital Sign Summary of Abnormal Findings for Each Subject|Safety evaluation will include vital sign summary for each subject. Only abnormal counts are included.|108 days (to 3 months post surgery)||||Participants|||Count of Participants
2531386|NCT03344861|Primary|Safety: Physical Examination Summaries of Non-normal Findings for Each Subject|Safety evaluation will include the physical examinations summary of non-normal findings for each subject.|108 days (to 3 months post surgery)||||Participants|||Count of Participants
2531387|NCT03344861|Secondary|ECOG Performance Status: Period III Follow-up (Day 103 - 108)|Number of Participants with ECOG Performance Status at Period III Follow-up (Day 103 - 108) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).|108 days (to 3 months post surgery)||||Participants|||Count of Participants
2531399|NCT03344861|Secondary|Microscopic Tissue Examination: Number of Participants With Atypical/Reactive Type 2 Pneumocytes in the Normal Lung After Surgery|Number of Participants with Atypical/Reactive Type 2 pneumocytes seen in the normal lung after surgery during the Microscopic Tissue Examination:|Day 13 to 18|Number of Participants with Atypical/Reactive Type 2 Pneumocytes in the normal lung after surgery determined during the Microscopic Tissue Examination.|||Participants|||Count of Participants
2539015|NCT03086265|Secondary|Duration of Anesthesia|Recorded from induction of anesthesia to patient's awakening/extubation|Duration of surgery (average approximately 1 hour)||||minutes||Standard Deviation|Mean
2531388|NCT03344861|Secondary|ECOG Performance Status: Period III Follow-up (Day 43 -48)|Number of Participants with ECOG Performance Status at Period III Follow-up (Day 43 -48) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).|Day 43 to 48||||Participants|||Count of Participants
2531389|NCT03344861|Secondary|ECOG Performance Status: Period III Follow-up (Day 20-25)|Number of Participants with ECOG Performance Status at Period III Follow-up (Day 20-25) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).|Day 20 to 25||||Participants|||Count of Participants
2531390|NCT03344861|Secondary|ECOG Performance Status: Period II Surgery (Day 13-18)|Number of Participants with ECOG Performance Status at Period II Surgery (Day 13-18) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).|Day 13 to 18||||Participants|||Count of Participants
2531391|NCT03344861|Secondary|ECOG Performance Status: Period 1 PDT Day 3|Number of Participants with ECOG Performance Status at Period 1 PDT Day 3, showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).|Day 3||||Participants|||Count of Participants
2531392|NCT03344861|Secondary|ECOG (Eastern Cooperative Oncology Group) Performance Status: Baseline|Number of Participants with ECOG Performance at Baseline showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).|Baseline (-30 to -1 Days)||||Participants|||Count of Participants
2531393|NCT03344861|Secondary|Microscopic Tissue Examination: Number of Participants With Organizing Pneumonia Pattern in the Normal Lung After Surgery|Number of Participants with Organizing pneumonia pattern in the normal lung after surgery seen during Microscopic Tissue Examination|Day 13 to 18||||Participants|||Count of Participants
2531394|NCT03344861|Secondary|Microscopic Tissue Examination: Number of Participants With Acute Alveolar Damage in the Normal Lung After Surgery|Number of Participants with Acute Alveolar damage in the normal lung after surgery seen during the Microscopic Tissue Examination|Day 13 to 18||||Participants|||Count of Participants
2531395|NCT03344861|Secondary|Microscopic Tissue Examination: Number of Participants With Large Vessel Damage Indicated by Fibrinoid Necrosis, Thrombus, Vasculitis in the Normal Lung After Surgery|Number of Participants with Large Vessel Damage indicated by fibrinoid necrosis, thrombus, vasculitis in the normal lung after surgery seen during Microscopic Tissue Examination|Day 13 to 18||||Participants|||Count of Participants
2531396|NCT03344861|Secondary|Microscopic Tissue Examination: Number of Participants With Necrosis in the Normal Lung After Surgery|Number of Participants with Necrosis seen in the normal lung after surgery during the Microscopic Tissue Examination|Day 13 to 18|Number of Participants with Necrosis in the normal lung after surgery|||Participants|||Count of Participants
2531397|NCT03344861|Secondary|Microscopic Tissue Examination: Number of Participants With Interstitial Fibrosis in the Normal Lung After Surgery|Number of participants with interstitial fibrosis in the normal lung after surgery seen during the Microscopic Tissue Examination|Day 13 to 18||||Participants|||Count of Participants
2531398|NCT03344861|Secondary|Microscopic Tissue Examination: Number of Participants With Mucus Plugging/Mucositis in the Normal Lung After Surgery|Number of Participants with Mucus Plugging/Mucositis seen in the normal lung after surgery during the Microscopic Tissue Examination.|Day 13 to 18||||Participants|||Count of Participants
2531597|NCT03334812|Secondary|PK Profile of LNA043 and of AngPTL3 in Serum Cmax|Local and systemic pharmacokinetics (PK) of LNA043 following a single i.a. administration|4 weeks|Pharmacokinetic Analysis Set|||ng/mL||Standard Deviation|Mean
2531401|NCT03344861|Secondary|Microscopic Tissue Examination: Number of Participants With Pneumonitis in the Normal Lung After Surgery|The Number of Participants with pneumonitis seen in the normal lung area after surgery following the microscopic tissue examination|Day 13 to 18|Microscopic Tissue Examination: Pneumonitis in the normal lung after surgery. Looked at Number of Participants with pneumonitis.|||Participants|||Count of Participants
2531402|NCT03344861|Secondary|Microscopic Tissue Examination: Number of Participants With Hemorrhage Seen After Surgery|The Number of Participants with hemorrhage seen during the microscopic tissue examination after surgery|Day 13 to 18|Number of Participants with Hemorrhage seen in normal lung area after surgery|||Participants|||Count of Participants
2531403|NCT03344861|Secondary|Microscopic Tissue Examination: Number of Participants With Cavitation in Normal Lung Area After Surgery|The number of participants with cavitation seen in the normal lung area from the microscopic tissue examination after surgery|Day 13 to 18|Number of participants with cavitation seen in normal lung area|||Participants|||Count of Participants
2531404|NCT03344861|Secondary|Microscopic Tissue Examination: Brisk Inflammatory Reaction After Surgery|The number of participants showing a brisk inflammatory reaction in the tumor area after surgery. This is determined through a histological examination. Brisk Inflammatory Reaction is defined as lymphocytes that infiltrate diffusely the entire tumor and/or infiltrate across the entire base of the tumor.|Day 13 to 18|The brisk inflammatory reaction percentage seen in the tumor area|||Participants|||Count of Participants
2531405|NCT03344861|Secondary|Microscopic Tissue Examination: Percent Tumor Cell Necrosis in Tumor Area After Surgery|The mean with standard deviation of the percent of tumor cell necrosis in the tumor area after surgery. The tumor itself was examined after it was removed to determine the percent of necrosis seen.|Day 13 to 18|All subjects were examined for percent tumor cell necrosis in the tumor area|||Percent of tumor||Standard Deviation|Mean
2531406|NCT03344861|Secondary|Summary of Microscopic Tissue Examination: Percentage of Participants With Complete Response After Surgery|The Percentage of Participants with Complete Response in Tumor area (no non-viable/necrotic tumor) after surgery|Day 13 to 18|Look at complete response in the tumor area|||percentage of participants|||Number
2531407|NCT03344861|Secondary|Macroscopic Tissue Examination|The mean measurement of tumor size after surgery. The largest diameter seen is measured.|Day 13 to 18|Photodynamic therapy - Photofrin|||CM||Standard Deviation|Mean
2531408|NCT03344861|Primary|Safety: Number of Participants With at Least One Adverse Event|Safety evaluation will include incidence of all adverse events, including serious and non-serious. The count of how many subjects experienced at least one adverse event.|108 days (to 3 months post surgery)||||Participants|||Count of Participants
2531409|NCT03344510|Secondary|Patient Preference for Injection With or Without Kinetic Anesthesia Device|"Qualitative measure of patient preference for injections with or without the kinetic anesthesia device.~Participants were asked whether they preferred the injection with or without the kinetic anesthesia device.~Counts below indicate the number of participants who preferred each type of injection."|This will occur immediately after the second injection|45 participants filled out this portion of the post-injection questionnaire, while two neglected this portion of the questionnaire.|||Participants|||Count of Participants
2531410|NCT03344510|Primary|Pain of Lidocaine Injection, Measured by Visual Analog Scale.|"Participants will be asked to mark the pain of injection on a 100mm visual analog scale. The visual analog scale is commonly used to measure acute pain, though it can be used in other settings. It consists of a line 100mm long. The left end is labeled no pain at all and the right end is labeled worst pain imaginable. Participants will rate pain by marking the scale where they feel that their level of pain falls on the scale. The length from 0 to the participant's mark will be measured in millimeters (for a range of 0 to 100 mm possible). Higher numbers will be considered more pain."|This measurement will occur immediately after each injection|See above|||mm on visual analog scale||Inter-Quartile Range|Median
2531411|NCT03343639|Secondary|Change in WI-NRS From Baseline to Day 3|Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The secondary outcome is the change in WI-NRS score at 3 days compared with Baseline.|3 days|These figures represent full analysis set.|||units on a scale||Standard Deviation|Least Squares Mean
2531412|NCT03343639|Secondary|Change in WI-NRS From Baseline to Day 7|Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The secondary outcome is the change in WI-NRS score at 7 days compared with Baseline.|Change from baseline to day 7|These figures represent full analysis set|||units on a scale||Standard Deviation|Least Squares Mean
2531413|NCT03343639|Secondary|WI-NRS 4-point Responder Rate at Week 4|Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Baseline and Week 4.|4 weeks|These figures represent full analysis set|||percentage of subjects|||Number
2531414|NCT03343639|Primary|WI-NRS 4-point Responder Rate at Week 8|Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Baseline and Week 8.|8 weeks|These figures represent full analysis set.|||% of subjects (incl. imputed data)|||Number
2531415|NCT03343080|Secondary|Richmond Agitation-Sedation Score (RASS)|The Richmond Agitation-Sedation Scale (RASS) is a medical scale used to measure the agitation or sedation level of a patient.. It is a 10-point scale comprised of four levels of agitation (+1 to +4), one level defining a calm and alert state (0) and five levels of sedation (-1 to -5). The higher the positive number (+) the more agitated or combative a patient is and the higher the negative number (-) the deeper the sedation of the patient.|4 hours post-extubation||||score on a scale||Standard Deviation|Mean
2531416|NCT03343080|Secondary|Total Duration of Mechanical Ventilation|Total amount of time that the participant is intubated as measured in minutes.|baseline through extubation||||minutes||Inter-Quartile Range|Median
2531417|NCT03343080|Primary|Total Sedation Requirements|Total amount of Propofol dose used as measured in total milligrams.|baseline through extubation|Only 10 subjects in the buffered lidocaine arm and 13 subjects in the air only arm received Propofol for sedation. The remaining subjects received other sedation drugs per physician discretion.|||milligrams||Standard Deviation|Mean
2531418|NCT03343067|Secondary|PROMIS Fatigue Short Form 6a Scores Over Time|The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue. Possible scores range from 6 to 30, 6 = not at all (no fatigue), and 30 = very much (most fatigue).|Month 0 (baseline), Month 6|Participants with an assessment at given time point.|||score on a scale||Standard Deviation|Mean
2531419|NCT03343067|Secondary|Health Endometriosis Treatment Satisfaction Questionnaire (ETSQ) Scores Over Time|The 6-item ETSQ was developed to assess patient-reported satisfaction with effects on endometriosis pain, dysmenorrhea, dyspareunia, amount of bleeding tolerability and overall treatment satisfaction. The ETSQ has a 7 point response scale. The range for this scale is 0 to 36, with lower ETSQ scores reflecting lower levels of satisfaction with endometriosis treatment.|Month 0 (baseline), Months 3, 6|Participants with an assessment at given time point.|||score on a scale||Standard Deviation|Mean
2531420|NCT03343067|Secondary|WPAI:SHP Scores Over Time: Percent Activity Impairment Due to Problem|Activity impairment due to health problem (the extent to which health problem affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, and is calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Month 0 (baseline), Month 6|Participants with an assessment at given time point.|||percentage impairment of activity||Standard Deviation|Mean
2531421|NCT03343067|Secondary|WPAI:SHP Scores Over Time: Percent Overall Work Impairment Due to Problem|The mean percentage of overall work impairment due to health problem (based on the WPAI questionnaire) is presented, and is calculated as: Absenteeism (%) + extent to which health problem decreased productivity (%)* [number of hours worked / (number of hours of work missed due to health problem + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Month 0 (baseline), Month 6|Participants with an assessment at given time point.|||percent overall work impairment||Standard Deviation|Mean
2531422|NCT03343067|Secondary|WPAI:SHP Scores Over Time: Percent Impairment While Working Due to Problem|Presenteeism (the extent to which health problem decreased productivity) is presented as the mean percentage of impairment while working due to health problem, and is calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI:SHP is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Month 0 (baseline), Month 6|Participants with an assessment at given time point.|||percent impairment while working||Standard Deviation|Mean
2531423|NCT03343067|Secondary|Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Scores Over Time: Percent Work Missed Due to Problem|Absenteeism is presented as the mean percentage of work time missed due to health problem (as reported on the WPAI:SHP), and is calculated as: 100*number of hours of work missed due to health problem / (number of hours of work missed due to health problem + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Month 0 (baseline), Month 6|Participants with an assessment at given time point.|||percent of work time missed||Standard Deviation|Mean
2531424|NCT03343067|Secondary|EQ-5D-5L VAS Scores Over Time: Health Today|The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate VAS indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).|Month 0 (baseline), Months 3, 6|Participants with an assessment at given time point.|||score on a scale||Standard Deviation|Mean
2531425|NCT03343067|Secondary|EQ-5D-5L Scores Over Time: Anxiety/Depression|The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).|Month 0 (baseline), Months 3, 6|Participants with an assessment at given time point.|||score on a scale||Standard Deviation|Mean
2531426|NCT03343067|Secondary|EQ-5D-5L Scores Over Time: Pain/Discomfort|The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).|Month 0 (baseline), Months 3, 6|Participants with an assessment at given time point.|||score on a scale||Standard Deviation|Mean
2531427|NCT03343067|Secondary|EQ-5D-5L Scores Over Time: Usual Activities|The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).|Month 0 (baseline), Months 3, 6|Participants with an assessment at given time point.|||score on a scale||Standard Deviation|Mean
2531428|NCT03343067|Secondary|EQ-5D-5L Scores Over Time: Self-Care|The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).|Month 0 (baseline), Months 3, 6|Participants with an assessment at given time point.|||score on a scale||Standard Deviation|Mean
2531429|NCT03343067|Secondary|EuroQol-5D 5 Level (EQ-5D-5L) Scores Over Time: Mobility|The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).|Month 0 (baseline), Months 3, 6|Participants with an assessment at given time point.|||score on a scale||Standard Deviation|Mean
2531430|NCT03343067|Secondary|EHP-30 Scores Over Time: Sexual Intercourse|The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.|Month 0 (baseline), Months 3, 6|Participants with an assessment at given time point.|||score on a scale||Standard Deviation|Mean
2531431|NCT03343067|Secondary|EHP-30 Scores Over Time: Self-Image|The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.|Month 0 (baseline), Months 3, 6|Participants with an assessment at given time point.|||score on a scale||Standard Deviation|Mean
2531432|NCT03343067|Secondary|EHP-30 Scores Over Time: Social Support|The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.|Month 0 (baseline), Months 3, 6|Participants with an assessment at given time point.|||score on a scale||Standard Deviation|Mean
2531433|NCT03343067|Secondary|EHP-30 Scores Over Time: Emotional Well-Being|The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.|Month 0 (baseline), Months 3, 6|Participants with an assessment at given time point.|||score on a scale||Standard Deviation|Mean
2531434|NCT03343067|Secondary|EHP-30 Scores Over Time: Control and Powerlessness|The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.|Month 0 (baseline), Months 3, 6|Participants with an assessment at given time point.|||score on a scale||Standard Deviation|Mean
2531435|NCT03343067|Secondary|Endometriosis Health Profile-30 (EHP-30) Scores Over Time: Pain|The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.|Month 0 (baseline), Months 3, 6|Participants with an assessment at given time point.|||score on a scale||Standard Deviation|Mean
2531436|NCT03343067|Secondary|Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time|The endometriosis-associated pain questionnaire is an 11-point NRS assessing overall endometriosis-associated pain over a 7-day recall period. Participants assessed their endometriosis-associated pain on a scale of 0 to 10, with 0 = no pain and 10 = worst pain ever.|Month 0 (baseline), Months 1, 2, 3, 4, 5, 6|Participants with an assessment at given time point.|||score on a scale||Standard Deviation|Mean
2531437|NCT03343067|Secondary|Patient Global Impression of Change (PGIC) Scores Over Time|The PGIC is a 7-point response scale where participants rate their endometriosis related pain as: very much improved (1), much improved (2), minimally improved (3), not changed (4), minimally worse (5), much worse (6), very much worse (7).|Months 1, 2, 3, 4, 5, 6|Participants with an assessment at given time point.|||score on a scale||Standard Deviation|Mean
2531438|NCT03343067|Secondary|Number of Analgesic Use Responders and Non-Responders Over Time|"Based only on reduction of rescue analgesics used. Responders were defined as:~participants with no analgesic use at screening and no analgesic use added~participants with NSAID only use at screening and NSAID dose stopped, decreased, or stable (<15% increase) and no opioid use added~participants with opioid only use at screening and opioid dose stopped, decreased, or stable (<15% increase), opioid dose stopped and NSAID substituted (any dose), opioid dose decreased and NSAID added (any dose)~participants with NSAID + opioid use at screening and any of the following: NSAID dose stopped + opioid analgesic use stopped, decreased, or stable (<15% increase); NSAID dose decreased + opioid analgesic use stopped, decreased, or stable (<15% increase); NSAID dose stable (< 15% increase) + opioid analgesic use stopped, decreased, or stable (<15% increase); NSAID dose increased by >15% + opioid analgesic use stopped; NSAID dose increased by >15% + opioid analgesic dose decreases."|Months 1, 2, 3, 4, 5, 6||||Participants|||Count of Participants
2531439|NCT03343067|Secondary|Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics|Based on average pill counts and assessed using a daily e-Diary. Permitted non-steroidal anti-inflammatory drugs (NSAIDs) included naproxen, ibuprofen, diclofenac, and celecoxib. Permitted opioids included hydrocodone + acetaminophen and codeine phosphate + acetaminophen.|Month 0 (baseline), Months 1, 2, 3, 4, 5, 6|Participants with an assessment at baseline and given time point.|||pills/day||Standard Deviation|Mean
2531440|NCT03343067|Secondary|Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS|The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.|Month 0 (baseline), Months 1, 2, 3, 4, 5, 6|Participants with an assessment at baseline and given time point.|||percentage change of score on a scale||Standard Deviation|Mean
2531441|NCT03343067|Secondary|Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia|The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.|Month 0 (baseline), Months 1, 2, 3, 4, 5, 6|Participants with an assessment at baseline and given time point.|||percentage change of units on a scale||Standard Deviation|Mean
2531442|NCT03343067|Secondary|Percent Change From Baseline to Each Month During the Treatment Period for NMPP|The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.|Month 0 (baseline), Months 1, 2, 3, 4, 5, 6|Participants with an assessment at baseline and given time point.|||percentage change of units on a scale||Standard Deviation|Mean
2531443|NCT03343067|Secondary|Percent Change From Baseline to Each Month During the Treatment Period for DYS|The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.|Month 0 (baseline), Months 1, 2, 3, 4, 5, 6|Participants with an assessment at baseline and given time point.|||percent change of units on a scale||Standard Deviation|Mean
2531444|NCT03343067|Secondary|Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS|The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.|Month 0 (baseline), Months 1, 2, 3, 4, 5, 6|Participants with an assessment at baseline and given time point.|||score on a scale||Standard Deviation|Mean
2531445|NCT03343067|Secondary|Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score|The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.|Month 0 (baseline), Months 1, 2, 3, 4, 5, 6|Participants with an assessment at baseline and given time point.|||score on a scale||Standard Deviation|Mean
2531446|NCT03343067|Secondary|Change From Baseline Over Time in Monthly Average NMPP Pain Score|The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.|Month 0 (baseline), Months 1, 2, 3, 4, 5, 6|Participants with an assessment at baseline and given time point.|||score on a scale||Standard Deviation|Mean
2531447|NCT03343067|Secondary|Change From Baseline Over Time in Monthly Average DYS Pain Score|"The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.~The analysis was based on a 28-day window. If a participant prematurely discontinued during the open-label period, based on the analysis window, some data might fall into Month 4 analysis."|Month 0 (baseline), Months 1, 2, 3, 4, 5, 6|Participants with an assessment at baseline and given time point.|||score on a scale||Standard Deviation|Mean
2531448|NCT03343067|Secondary|Proportion of Responders Over Time (Not Taking Into Consideration of Analgesic Use)|As assessed by change and percent change from Baseline in average pain score and rescue analgesic use monthly for DYS, NMPP, dyspareunia, and Daily Diary endometriosis-associated pain score via NRS, respectively.|Month 0 (baseline), Months 1, 2, 3, 4, 5, 6|Analysis was intended to be based on ROC threshold, which could not be calculated for this endpoint due to low enrollment at the time of study termination.||||||
2531449|NCT03343067|Secondary|Proportion of Responders Over Time|As assessed by change and percent change from baseline in average pain score and rescue analgesic use monthly for DYS, NMPP, dyspareunia, and Daily Diary endometriosis-associated pain score via NRS, respectively.|Month 0 (baseline), Months 1, 2, 3, 4, 5, 6|Analysis was intended to be based on ROC threshold, which could not be calculated for this endpoint due to low enrollment at the time of study termination.||||||
2531450|NCT03343067|Secondary|Percentage of Participants With 30% or More Reduction From Baseline Based on the 35 Day Mean of the Daily Diary Endometriosis-Associated Pain Score Via NRS at Month 6|The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window.|Month 6|Participants with both baseline and post-baseline values for Daily Diary Endometriosis-Associated Pain Score via NRS.|||percentage of participants|||Number
2531451|NCT03343067|Secondary|Change From Baseline in Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids) at Month 6|Based on average pill counts and assessed using the daily e-Diary. Permitted non-steroidal anti-inflammatory drugs (NSAIDs) included naproxen, ibuprofen, diclofenac, and celecoxib. Permitted opioids included hydrocodone + acetaminophen and codeine phosphate + acetaminophen.|Month 0 (baseline), Month 6|Participants with an assessment at baseline and given time point.|||pills/day||Standard Deviation|Mean
2531452|NCT03343067|Secondary|Change From Baseline in Daily Diary Endometriosis-Associated Pain Score Via Numeric Rating Scale (NRS) at Month 6|The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.|Month 0 (baseline), Month 6|Participants with an assessment at baseline and given time point.|||score on a scale||Standard Deviation|Mean
2531453|NCT03343067|Secondary|Change From Baseline in Dyspareunia at Month 6|The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.|Month 0 (baseline), Month 6|Participants with an assessment at baseline and given time point.|||score on a scale||Standard Deviation|Mean
2531454|NCT03343067|Secondary|Change From Baseline in NMPP at Month 6|The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.|Month 0 (baseline), Month 6|Participants with an assessment at baseline and given time point.|||score on a scale||Standard Deviation|Mean
2531455|NCT03343067|Secondary|Change From Baseline in DYS at Month 6|The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.|Month 0 (baseline), Month 6|Participants with an assessment at baseline and given time point.|||score on a scale||Standard Deviation|Mean
2531456|NCT03343067|Primary|Proportion of Responders at Month 6 Based on NMPP Pain Scale|Proportion of responders at Month 6 based upon the scale for NMPP pain scale (ranging from 0 [none] to 3 [severe]) using the daily e-Diary, as well as no increased analgesic rescue use for endometriosis-associated pain.|Month 6|Analysis was intended to be based on ROC threshold, which could not be calculated, since only 1 participant had a Month 6 assessment for this endpoint at the time of study termination.||||||
2531457|NCT03343067|Primary|Proportion of Responders at Month 6 Based on DYS Pain Scale|Proportion of responders at Month 6 based upon the scale for DYS pain scale (ranging from 0 [none] to 3 [severe]) using the daily e-Diary, as well as no increased analgesic rescue use for endometriosis-associated pain.|Month 6|Analysis was intended to be based on a receiver operating characteristic (ROC) threshold, which could not be calculated, since only 1 participant had a Month 6 assessment for this endpoint at the time of study termination.||||||
2531458|NCT03342560|Primary|Interoperator and Intraoperator Agreement in m/s and kPA Units|In 20 patients we collected 10 shear wave elastography measurements in m/s and kPA units. Using one of the available ultrasound systems, 2 operators collected these measurements in 2 visits. Theoretically, m/s to kPA conversion can be made using an equation. However, some systems provide opportunity to get data in both units. Although algebraically m/s and kPA can be converted to each other, we found some minor differences in terms of inter-operator and intra-operator agreement.|Visit 1 and Visit 2, an average of 2.5 hours for each visit||||Intraclass correlation coefficient value||95% Confidence Interval|Number
2531459|NCT03342560|Primary|Deviations From Suggested Guidelines- Any Effect on Agreement|We collected guideline suggested shear wave elastography measurements from 20 patients. Guidelines suggest collecting 1) 10 measurements, 2) Asking patient to hold breath during the measurements. As a deviation from guideline suggestions, we collected measurements during free breath movements without asking patient to hold breath. As a deviation from the guideline suggestions, fewer number of measurements (3 measurements) were collected with asking the patient to hold breath during the measurements. All measurements were collected using one type of ultrasound system. All measurements were collected by 2 operators in 2 visits.|Visit 1 and Visit 2, an average of 2.5 hours for each visit||||correlation coefficient||95% Confidence Interval|Number
2531460|NCT03341923|Primary|"Percentage of Subjects With Investigator-graded Lens Centration of Optimal"|Lens centration was assessed by slit-lamp microscopy and graded on a 5-point scale, where 0=Optimal/Centered and 4=Severe decentration (with corneal exposure). One target eye was randomly selected for analysis.|Day 14, each product|Full Analysis Set with data available|||percentage of subjects|||Number
2531461|NCT03341728|Secondary|Change in Margin of Stability Variability After 10 Min of Walking|Change in step-to-step fluctuations in margin of stability (the distance between the lateral boundary of the foot and the body's center of mass, measured in cm)|Baseline, 10 minutes||||cm||Standard Deviation|Mean
2531462|NCT03341728|Secondary|Change in Cognitive-motor Interference Response Time After 10 Min of Walking|Response time in performing an auditory stroop test (cognitive dual-task)|Baseline, 10 minutes|Data could not be collected because noise from the treadmill motor interfered with the collection of auditory stroop test responses.||||||
2531463|NCT03341728|Secondary|Change in Cognitive-motor Interference Accuracy After 10 Min of Walking|Accuracy performing an auditory stroop test (cognitive dual-task)|Baseline, 10 minutes|Data could not be collected because noise from the treadmill motor interfered with the collection of auditory stroop test responses.||||||
2531464|NCT03341728|Primary|Change in Foot Placement Targeting Accuracy After 10 Min of Walking|Accuracy of performing foot placement targeting task. i.e., distance between heel marker at initial contact and target line (measured using three-dimensional motion capture during walking).|Baseline, 10 minutes|Data could not be collected because motion capture markers tracking the location of the targeting device were too often obstructed to be able to reliably estimate foot placement targeting accuracy.||||||
2531465|NCT03341728|Primary|Change in Kinematic Variability After 10 Min of Walking|Magnitude of step-to-step corrections in step width measured in cm|Baseline, 10 minutes||||cm||Standard Deviation|Mean
2531466|NCT03341728|Primary|Change in Postural Sway After 10 Min of Walking|Magnitude of side-to-side postural sway|Baseline, 10 minutes||||cm||Standard Deviation|Mean
2531467|NCT03341637|Secondary|Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study|An SAE was defined as any untoward medical occurrence or effect that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.|From first vaccination (Day 1) through end of study (Day 270)|Safety Set included of all participants who received at least 1 dose of trial vaccine.|||percentage of participants|||Number
2531468|NCT03341637|Secondary|Percentage of Participants With Medically Attended AEs (MAAEs) Throughout the Study|MAAEs were defined as AEs leading to a medical visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria.|From first vaccination (Day 1) through end of study (Day 270)|Safety Set included of all participants who received at least 1 dose of trial vaccine.|||percentage of participants|||Number
2531469|NCT03341637|Secondary|Percentage of Participants With Any Unsolicited Adverse Events (AEs) Following Each Vaccination|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.|Within 28 days after each vaccination|Safety Set included of all participants who received at least 1 dose of trial vaccine. Number analyzed is the number of participants with data available at the given timepoint. Only categories for which there was at least 1 participant are reported.|||percentage of participants|||Number
2531479|NCT03340961|Primary|Investigator Global Assessment (IGA) 0=Clear, 1=Near Clear, 2=Mild, 3=Moderate, 4=Severe|Proportion of subjects with Investigator Global Assessment (IGA) 'treatment success' - Grade 0 or 1 at the end of study with at least 2 grade reduction from Baseline to Week 16.|16 weeks|The FAS (full analysis set) included all subjects that had at least one post Baseline efficacy assessment.|||Participants|||Count of Participants
2531480|NCT03340805|Other Pre-specified|Adverse Events|Venous thromboembolism|up to seven days post-randomization||||Participants|||Count of Participants
2547121|NCT02912195|Secondary|Pain Score (NRS 0-10)|Pain score recorded on the numeric rating scale 0-10.|At 30 minutes||||units on a scale||95% Confidence Interval|Mean
2531470|NCT03341637|Secondary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity|Solicited systemic AEs were collected by participants using diary cards within 14 days after vaccination and included fever, headache, tiredness or weakness (asthenia), feeling of discomfort (malaise) and muscle pain (myalgia). Severity scales for headache were none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents normal activity with or without treatment. Severity scales for others were none, mild: no interference with daily activity, moderate: interference with daily activity and severe: prevents daily activity. A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it.|Within 14 days after each vaccination|Safety Set included of all participants who received at least 1 dose of trial vaccine. Number analyzed is the number of participants with data available at the given timepoint. Only categories for which there was at least 1 participant are reported.|||percentage of participants|||Number
2531471|NCT03341637|Secondary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity|Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), redness (erythema) (<2.5 cm, mild: 2.5-5 cm, moderate: >5 to <=10 cm, severe: >10 cm) and swelling (edema/induration) (<2.5 cm, mild: 2.5-5 cm, moderate: >5 to <=10 cm, severe: >10 cm).|Within 7 days after each vaccination|Safety Set included of all participants who received at least 1 dose of trial vaccine. Number analyzed is the number of participants with data available at the given timepoint. Only categories for which there was at least 1 participant are reported.|||percentage of participants|||Number
2531472|NCT03341637|Secondary|Seropositivity Rates for Multiple (2, 3 or 4) Dengue Serotypes|Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10.|One month and six months post second dose (Day 120 and Day 270)|PPS: all participants seronegative to all serotypes of dengue virus at baseline who received at least 1 dose of trial vaccine, who had a valid pre-dose (baseline) and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. Number analyzed: participants with data available at given time-point.|||percentage of participants||95% Confidence Interval|Number
2531473|NCT03341637|Secondary|Seropositivity Rates for Each of the 4 Dengue Serotypes|Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.|One month and six months post second dose (Day 120 and Day 270)|PPS: all participants seronegative to all serotypes of dengue virus at baseline who received at least 1 dose of trial vaccine, who had a valid pre-dose (baseline) and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. Number analyzed: participants with data available at given time-point.|||percentage of participants||95% Confidence Interval|Number
2531474|NCT03341637|Secondary|Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270|GMTs of neutralizing antibodies were measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity is defined as reciprocal neutralizing titer ≥10.|Six months post second dose (Day 270)|PPS: all participants seronegative to all serotypes of dengue virus at baseline who received at least 1 dose of trial vaccine, who had a valid pre-dose (baseline) and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. Number analyzed: participants with data available at given time-point.|||titer||95% Confidence Interval|Geometric Mean
2531475|NCT03341637|Primary|Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120|GMTs of neutralizing antibodies were measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity is defined as reciprocal neutralizing titer ≥10.|One month post second dose (Day 120)|Per Protocol Set (PPS): all participants seronegative to all serotypes of dengue virus at baseline who received at least 1 dose of trial vaccine, who had a valid pre-dose (baseline) and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. Number analyzed: participants with data available at given time-point.|||titer||95% Confidence Interval|Geometric Mean
2531476|NCT03341546|Primary|Accuracy of the Computational Model|"The computational model was used to estimate the patient's anterior-posterior abdominal depth using the digital radiographic image, the exposure factors with which it was acquired and a priori knowledge relating to the x-ray unit and digital detector.~The outcome measure was the accuracy with which the computational model estimates the patient's anterior-posterior abdominal depth. It was determined by comparing the estimate to measured anterior-posterior abdominal depth (measured at the time of the x-ray examination). Results are expressed as a percentage deviation; a low % deviation is more accurate, a high % deviation less accurate."|2 months||||percentage agreement (est/measured)||Standard Deviation|Mean
2531477|NCT03340961|Secondary|Median Change in RosaQoL (Rosacea Quality of Life) Score From Baseline to Week 16|The RosaQoL assessment is carried out by the Investigator using the validated RosaQoL questionnaire, at every study visit from Screening up to Week 16 (or at early termination). The RosaQol tool has 21 questions related to the impact that Rosacea has on various dimensions influencing quality of life. Each question is graded from 1 (Never) - 5 (All the time), thus leading to a minimum score of 21 (21 x 1) to a maximum score of 105 (21 x 5) per subject at every visit. Higher the score, poorer is the quality of life. This outcome measured the change in the score from Baseline to Week 16.|Median change in the score from Baseline to Week 16|FAS Population|||score on a scale||Full Range|Median
2531478|NCT03340961|Primary|Total Inflammatory Lesion Count Reduction|The total inflammatory lesion count is carried out by visual inspection by the Investigator at every study visit from Screening up to Week 16 (or at early termination). Inflammatory lesions will be recorded on a diagram of a human face, divided in 4 quadrants.|16 Weeks|FAS population|||Count of lesions||Standard Deviation|Mean
2539016|NCT03086265|Secondary|Apnea Time|Recorded from induction of anesthesia to the return of spontaneous ventilation.|Duration of surgery (average approximately 1 hour)||||minutes||Standard Deviation|Mean
2531484|NCT03340805|Other Pre-specified|Hospital-free Days|"The number of calendar days alive and out of the hospital between randomization (day 0) and day 27 with death prior hospital discharge defined as zero hospital-free days"|up to 28 days following randomization||||days alive and free of hospitalization||Inter-Quartile Range|Median
2531485|NCT03340805|Other Pre-specified|Mortality|Proportion of enrolled patients who do not survive|up to 90 days following randomization||||Participants|||Count of Participants
2531486|NCT03340805|Secondary|"Acceptability of Enrollment Using Exception From Informed Consent"|Proportion of eligible patients who meet criteria for EFIC who are enrolled, randomized, and treated with study fluid and do not withdraw prior to completion of the follow-up phase|up to 6 months||||Participants|||Count of Participants
2531487|NCT03340805|Secondary|Enrollment of Eligible Patients|Proportion of eligible patients treated in the pediatric ED who are enrolled, randomized, and treated with study fluid|up to 6 months||||Participants|||Count of Participants
2531488|NCT03340805|Primary|Compliance With Study Fluid Administration in the Assigned Study Arm|Proportion of total crystalloids administered as saline in each arm during the intervention phase|up 48 hours after randomization||||Proportion of total crystalloids adminis||Inter-Quartile Range|Median
2531489|NCT03340610|Primary|Reduction in Macular Edema|"Reduction in macular edema measured as~Proportion of eyes with baseline SD OCT CST >350 um demonstrating >15% reduction at week 52 from baseline~Proportion of eyes that demonstrate SD OCT CST <305um (males) and <290 um (females) at week 52 from baseline"|52 weeks from baseline|Answered to the query of PRS review|||Participants|||Count of Participants
2531490|NCT03339726|Secondary|Change From Baseline in Sinus Pressure/Tenderness Scores|Change from baseline in Sinus Pressure/Tenderness Scores at 24 hours. This is an 8 point scale with 0=None and 7=Severe.|0-24 hours|Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.|||units on a scale||Standard Error|Mean
2531491|NCT03339726|Secondary|Change From Baseline in Sinus Pressure/Tenderness Scores|Change from baseline in Sinus Pressure/Tenderness Scores at 12 hours. This is an 8 point scale with 0=None and 7=Severe.|0-12 hours|Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.|||units on a scale||Standard Error|Mean
2531492|NCT03339726|Secondary|Change From Baseline in Sinus Pressure/Tenderness Scores|Change from baseline in Sinus Pressure/Tenderness Scores at 10 hours. This is an 8 point scale with 0=None and 7=Severe.|0-10 hours|Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.|||units on scale||Standard Error|Mean
2531493|NCT03339726|Secondary|Change From Baseline in Sinus Pressure/Tenderness Scores|Change from baseline in Sinus Pressure/Tenderness Scores at 8 hours. This is an 8 point scale with 0=None and 7=Severe.|0-8 hours|Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.|||units on a scale||Standard Error|Mean
2531494|NCT03339726|Secondary|Change From Baseline in Sinus Pressure/Tenderness Scores|Change from baseline in Sinus Pressure/Tenderness Scores at 6 hours. This is an 8 point scale with 0=None and 7=Severe.|0-6 hours|Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.|||units on a scale||Standard Error|Mean
2531495|NCT03339726|Secondary|Change From Baseline in Sinus Pressure/Tenderness Scores|Change from baseline in Sinus Pressure/Tenderness Scores at 4 hours.|0-4 hours|Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.|||units on a scale||Standard Error|Mean
2531496|NCT03339726|Secondary|Change From Baseline in Sinus Pressure/Tenderness Scores|Change from baseline in Sinus Pressure/Tenderness Scores at 2 hours. This is an 8 point scale with 0=None and 7=Severe.|0-2 hours|Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.|||units on a scale||Standard Error|Mean
2531497|NCT03339726|Secondary|Average Change From Baseline in Sinus Pressure/Tenderness Scores|Change from baseline in Sinus Pressure/Tenderness Scores averaged over assessments at 2, 4, 6, 8, 10, and 12 hours. This is an 8 point scale with 0=None and 7=Severe.|0-12 hours|Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.|||units on a scale||Standard Error|Mean
2531498|NCT03339726|Secondary|Change From Baseline in the Nasal Congestion Severity Score|Change from baseline in the Nasal Congestion Severity Score at 24 hours. This is an 8 point scale with 0=None and 7=Severe.|0-24 hours|Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.|||units on a scale||Standard Error|Mean
2531499|NCT03339726|Secondary|Change From Baseline in the Nasal Congestion Severity Score|Change from baseline in the Nasal Congestion Severity Score at 12 hours. This is an 8 point scale with 0=None and 7=Severe.|0-12 hours|Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.|||units on a scale||Standard Error|Mean
2531500|NCT03339726|Secondary|Change From Baseline in the Nasal Congestion Severity Score|Change from baseline in the Nasal Congestion Severity Score at 10 hours. This is an 8 point scale with 0=None and 7=Severe.|0-10 hours|Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.|||units on a scale||Standard Error|Mean
2531501|NCT03339726|Secondary|Change From Baseline in the Nasal Congestion Severity Score|Change from baseline in the Nasal Congestion Severity Score at 8 hours. This is an 8 point scale with 0=None and 7=Severe.|0-8 hours|Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.|||units on a scale||Standard Error|Mean
2531623|NCT03334734|Secondary|Minimal Plasma Concentration (Сmin) of PBTZ169|Minimal plasma concentration (Сmin) of PBTZ169: concentration measurement following single dosing|for single dosing , Day 1 (24 h after 1st dose of PBTZ169)|PKA|||ng/ml||Standard Deviation|Mean
2531502|NCT03339726|Secondary|Change From Baseline in the Nasal Congestion Severity Score|Change from baseline in the Nasal Congestion Severity Score at 6 hours. This is an 8 point scale with 0=None and 7=Severe.|0-6 hours|Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.|||units on a scale||Standard Error|Mean
2531503|NCT03339726|Secondary|Change From Baseline in the Nasal Congestion Severity Score|Change from baseline in the Nasal Congestion Severity Score at 4 hours. This is an 8 point scale with 0=None and 7=Severe.|0-4 hours|Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.|||units on a scale||Standard Error|Mean
2531504|NCT03339726|Secondary|Change From Baseline in the Nasal Congestion Severity Score|Change from baseline in the Nasal Congestion Severity Score at 2 hours. This is an 8 point scale with 0=None and 7=Severe.|0-2 hours|Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.|||units on a scale||Standard Error|Mean
2531505|NCT03339726|Secondary|Average Change From Baseline in the Nasal Congestion Severity Score|Average change from baseline in the Nasal Congestion Severity Score averaged over hours 8-12. This is an 8 point scale with 0=None and 7=Severe.|0-12 hours|Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.|||units on a scale||Standard Error|Mean
2531506|NCT03339726|Primary|Mean Change From Baseline in the Nasal Congestion Severity Score|Average change from baseline in the Nasal Congestion Severity Score on an 8 point scale with 0=None and 7=Severe. Change from baseline in the Nasal Congestion Severity Score averaged over assessments at 2, 4, 6, 8, 10, and 12 hours.|0-12 hours|Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity.|||units on a scale||Standard Error|Mean
2531507|NCT03339583|Other Pre-specified|REM Sleep Percentage|Percentage of Total Sleep Time|once at baseline assessment|All randomised participants who filled baseline set of questionnaires|||percentage of total sleep time||Standard Deviation|Mean
2531508|NCT03339583|Other Pre-specified|N3 NREM Sleep Percentage|Percentage of Total Sleep Time|once at baseline assessment|All randomised participants who filled baseline set of questionnaires|||percentage of total sleep time||Standard Deviation|Mean
2531509|NCT03339583|Other Pre-specified|N2 NREM Sleep Percentage|Percentage of Total Sleep Time|once at baseline assessment|All randomised participants who filled baseline set of questionnaires|||percentage of time||Standard Deviation|Mean
2531510|NCT03339583|Other Pre-specified|N1 NREM Sleep Percentage|Percentage of Total Sleep Time|once at baseline assessment|All randomised participants who filled baseline set of questionnaires|||percentage of total sleep time||Standard Deviation|Mean
2531511|NCT03339583|Other Pre-specified|Amount of Awakenings|Number of awakenings between sleep onset and final morning awakening|once at baseline assessment|All randomised participants who filled baseline set of questionnaires|||awakenings||Standard Deviation|Mean
2531512|NCT03339583|Other Pre-specified|Wake After Sleep Onset|total duration of all periods of wakefulness between sleep onset and final awakening in the morning|once at baseline assessment|All randomised participants who filled baseline set of questionnaires|||minutes||Standard Deviation|Mean
2531513|NCT03339583|Other Pre-specified|Sleep Efficiency|Prercentage of Total Bed Time|once at baseline assessment|Analysis included all participants who were randomized and filled set of questionnaires at baseline assessment|||percentage of polysomnogram time||Standard Deviation|Mean
2531514|NCT03339583|Other Pre-specified|Total Sleep Time|total sleep episode minus wake time|once at baseline assessment|Analysis included all randomized participants|||hours||Standard Deviation|Mean
2531515|NCT03339583|Other Pre-specified|Sleep Latency|time period from bedding to sleep onset|once at baseline assessment|Participants dropped out during the first treatment course and therefore not completed the second treatment course were included only in the analysis for first treatment course and were not analyzed for treatment sequence effect|||minutes||Standard Deviation|Mean
2531516|NCT03339583|Other Pre-specified|Toronto Alexithymia Scale (TAS-20)|Degree of alexithymia evaluated by Toronto Alexithymia scale (20 questions) Measure Description: 0-100 scores. higher values represent worse outcome|once at baseline assessment|All randomised participants who filled baseline set of questionnaires|||scores on a scale||Standard Deviation|Mean
2531517|NCT03339583|Secondary|Trait Anxiety Subscale (STAI)|STAI is a 2-part questionnaire assessing state (situational) and trait anxiety. Trait anxiety subscale comprise 20 items rated on a 4-point Likert scale. Minimum score for each subscale is 20 and maximum score is 80 points. Higher total score indicates more severe anxiety symptoms|on the initial examination (Day 1/Week 1/Month 1), after first treatment course (Day 14/Week 2/ Month 1), after washout period (Day 28/ Week 4/Month 1), after second treatment course (Day 42/Week 6/Month 8), after second washout (Day 56/Week 8/ Month 2)|Participants dropped out during the first treatment course and therefore not completed the second treatment course were included only in the analysis for first treatment course and were not analyzed for treatment sequence effect|||units on a scale||Standard Deviation|Mean
2531518|NCT03339583|Secondary|Pittsburgh Sleep Quality Index|19-item questionnaire evaluating sleep quality over the past month. The first 4 items are open questions, items 5 to 19 are rated on a 4-point Likert scale. A total score range from 0 to 21. A score > 5 suggests poor sleep quality.|on the initial examination (Day 1/Week 1/Month 1), after first treatment course (Day 14/Week 2/ Month 1), after washout period (Day 28/ Week 4/Month 1), after second treatment course (Day 42/Week 6/Month 8), after second washout (Day 56/Week 8/ Month 2)|Participants dropped out during the first treatment course and therefore not completed the second treatment course were included only in the analysis for first treatment course and were not analyzed for treatment sequence effect|||units on a scale||Standard Deviation|Mean
2531598|NCT03334812|Secondary|Bi-layer Collagen Organization Based on MRI Measurements|MRI T2 maps were generated and zonal T2 ratios (superficial layer T2 / deep layer T2) were calculated to assess the collagen fiber organization in the SCD cartilage region.|Week 12 and Week 28|Pharmacodynamic analysis set. Subjects with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.|||Ratio||Standard Error|Mean
2531519|NCT03339583|Secondary|Sleep Hygiene Index|questionnaire assessing sleep related behavior in 13 item rated on a 5-point Likert scale.Minimum score 13 points and maximum score 65 points. Higher total score represents worse sleep hygiene|on the initial examination (Day 1/Week 1/Month 1), after first treatment course (Day 14/Week 2/ Month 1), after washout period (Day 28/ Week 4/Month 1), after second treatment course (Day 42/Week 6/Month 8), after second washout (Day 56/Week 8/ Month 2)|Participants dropped out during the first treatment course and therefore not completed the second treatment course were included only in the analysis for first treatment course and were not analyzed for treatment sequence effect|||units on a scale||Standard Deviation|Mean
2531520|NCT03339583|Secondary|Dysfunctional Beliefs About Sleep Scale|questionnaire assessing sleep related cognitions in 16 item rated on a 10-point Likert scale. Minimum score is 0, maximum score is 160 points. Higher total score represents more intensive disfunctional beliefs|on the initial examination (Day 1/Week 1/Month 1), after first treatment course (Day 14/Week 2/ Month 1), after washout period (Day 28/ Week 4/Month 1), after second treatment course (Day 42/Week 6/Month 8), after second washout (Day 56/Week 8/ Month 2)|Participants dropped out during the first treatment course and therefore not completed the second treatment course were included only in the analysis for first treatment course and were not analyzed for treatment sequence effect|||units on a scale||Standard Deviation|Mean
2531521|NCT03339583|Secondary|State Anxiety Subscale (STAI)|State trait anxiety scale is a 2-part questionnaire assessing state (situational) and trait anxiety. State anxiety subscale comprise 20 items rated on a 4-point Likert scale. Minimum score for subscale is 20 and maximum score is 80 points. Higher total score indicates more severe anxiety symptoms|on the initial examination (Day 1/Week 1/Month 1), after first treatment course (Day 14/Week 2/ Month 1), after washout period (Day 28/ Week 4/Month 1), after second treatment course (Day 42/Week 6/Month 8), after second washout (Day 56/Week 8/ Month 2)|Participants dropped out during the first treatment course and therefore not completed the second treatment course were included only in the analysis for first treatment course and were not analyzed for treatment sequence effect|||units on a scale||Standard Deviation|Mean
2531522|NCT03339583|Secondary|Beck Depression Inventory|21-item questionnaire assessing (on 4-point Likert scales) the intensity of depressive symptoms in the past week. Minimum score 0, maximum score 63 points. Higher total score represents more severe depressive symptoms|on the initial examination (Day 1/Week 1/Month 1), after first treatment course (Day 14/Week 2/ Month 1), after washout period (Day 28/ Week 4/Month 1), after second treatment course (Day 42/Week 6/Month 8), after second washout (Day 56/Week 8/ Month 2)|Participants dropped out during the first treatment course and therefore not completed the second treatment course were included only in the analysis for first treatment course and were not analyzed for treatment sequence effect|||units on a scale||Standard Deviation|Mean
2531523|NCT03339583|Primary|Insomnia Severity Index|self reported insomnia symptoms severity by Insomnia severity index . Each item is scored 0 (no problem) - 4 (very big problem) with total between 0-28 (absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).|For BBT-I-first group: on the initial examination (Day 1/Week 1/Month 1), after first treatment course (Day 14/Week 2/Month 1); For zopiclone-first group: after washout period (Day 28/Week 4/Month 1) after second treatment course (Day 42/Week 6/Month 2)|Participants dropped out during the first treatment course and therefore not completed the second treatment course were included only in the analysis for first treatment course and were not analyzed for treatment sequence effect|||units on a scale||Standard Deviation|Mean
2531524|NCT03339453|Secondary|PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon||Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration|All enrolled participants who received at least 1 dose of the study drug with evaluable PK data.|||Hour (hr)||Full Range|Median
2531525|NCT03339453|Secondary|PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon||Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration|All enrolled participants who received at least 1 dose of the study drug with evaluable PK data.|||picograms per millilitre (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2531526|NCT03339453|Secondary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Baseline Adjusted Glucagon||Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration|All enrolled participants who received at least 1 dose of the study drug with evaluable PK data.|||picogram*hour per millilitre (pg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2531527|NCT03339453|Secondary|PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose||Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration|All enrolled participants who received at least 1 dose of the study drug with evaluable PD data.|||Hour (hr)||Full Range|Median
2531528|NCT03339453|Secondary|Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax)||Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration|All enrolled participants who received at least 1 dose of the study drug with evaluable PD data.|||Milligrams per deciliter (mg/dL)||Geometric Coefficient of Variation|Geometric Mean
2531529|NCT03339453|Primary|Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia|Treatment success is defined as an increase in plasma glucose to greater than or equal to (≥) 70 milligrams per deciliter (mg/dL) or an increase of ≥20 mg/dL from plasma glucose nadir, without receiving additional actions to increase the plasma glucose concentration. Nadir is defined as the minimum plasma glucose concentration at the time of or within 10 minutes following glucagon administration.|Pre-dose up to 30 minutes post each glucagon administration|All participants who completed both treatment visits with evaluable data.|||Participants|||Count of Participants
2531530|NCT03338816|Secondary|Change From Baseline in the Physical Component Summary (PCS) of the 12-Item Short Form Survey (SF-12) in Participants With AIP|The SF-12 is a survey designed for use in patients with multiple chronic conditions. This 12-item scale can be used to assess the physical and mental health of respondents. 10 of the 12 questions are answered on a 5 point likert scale and 2 are answered on a 3 point likert scale. The questions are then scored and weighted into 2 subscales, physical health and mental health. Respondents can have a score that ranges from 0-100 with 100 being the best score and indicating high physical or mental health. A 3 point change in SF-12 score reflects a meaningful difference. A higher score indicates improvement.|Baseline and 6 months|FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.|||score on a scale||Standard Error|Least Squares Mean
2531531|NCT03338816|Secondary|Average Change From Baseline in Weekly Mean Score Daily Worst Nausea Score as Measured by NRS in Participants With AIP|Participants rated worst daily nausea score in an eDiary using an 11-point NRS, in which 0=no nausea and 10=worst nausea. Daily eDiary entries were averaged into a weekly (i.e. 7 day) score. The change from baseline in weekly mean scores is defined as the postbaseline weekly mean score minus the baseline score. Lower scores indicate an improvement.|Baseline and 6 months|FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.|||score on a scale||Standard Error|Least Squares Mean
2531532|NCT03338816|Secondary|AUC of the Change From Baseline in Weekly Mean Score Daily Worst Nausea Score as Measured by NRS in Participants With AIP|Participants rated worst daily nausea score in an eDiary using an 11-point NRS, in which 0=no nausea and 10=worst nausea. Daily eDiary entries were averaged into a weekly (i.e. 7 day) score. The change from baseline in weekly mean scores is defined as the postbaseline weekly mean score minus the baseline score. Lower scores indicate an improvement. The 6-month AUC was calculated based on change from baseline in weekly mean scores.|Baseline and 6 months|FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.|||score on a scale||Standard Error|Least Squares Mean
2531533|NCT03338816|Secondary|Average Change From Baseline in Weekly Mean Score of Daily Worst Fatigue Score as Measured by the Brief Fatigue Inventory-Short Form (BFI-SF) NRS in Participants With AIP|Participants rated daily worst fatigue score in an eDiary using the 11-point BFI-SF NRS, in which 0=no fatigue and 10=worst fatigue. Daily eDiary entries were averaged into a weekly (i.e. 7 day) score. The change from baseline in weekly mean scores is defined as the postbaseline weekly mean score minus the baseline score. Lower scores indicate an improvement.|Baseline and 6 months|FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.|||score on a scale||Standard Error|Least Squares Mean
2531534|NCT03338816|Secondary|AUC of the Change From Baseline in Weekly Mean Score of Daily Worst Fatigue Score as Measured by the Brief Fatigue Inventory-Short Form (BFI-SF) NRS in Participants With AIP|Participants rated daily worst fatigue score in an eDiary using the 11-point BFI-SF NRS, in which 0=no fatigue and 10=worst fatigue. Daily eDiary entries were averaged into a weekly (i.e. 7 day) score. The change from baseline in weekly mean scores is defined as the post baseline weekly mean score minus the baseline score. Lower scores indicate an improvement. The 6-month AUC was calculated based on change from baseline in weekly mean scores.|Baseline and 6 months|FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.|||score on a scale*week||Standard Error|Least Squares Mean
2531535|NCT03338816|Secondary|Average Change From Baseline in Weekly Mean Score of Daily Worst Pain as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Numeric Rating Scale (NRS) in Participants With AIP|Participants rated worst daily pain score in an eDiary using the 11-point BPI-SF NRS, in which 0=no pain and 10=worst pain. Daily eDiary entries were averaged into a weekly (i.e. 7 day) score. The change from baseline in weekly mean scores is defined as the postbaseline weekly mean score minus the baseline score. Lower scores indicate an improvement.|Baseline and 6 months|FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.|||score on a scale||Inter-Quartile Range|Median
2531536|NCT03338816|Secondary|Area Under the Curve (AUC) of the Change From Baseline in Weekly Mean Score of Daily Worst Pain as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Numeric Rating Scale (NRS) in Participants With AIP|Participants rated worst daily pain score in an eDiary using the 11-point BPI-SF NRS, in which 0=no pain and 10=worst pain. Daily eDiary entries were averaged into a weekly (i.e. 7 day) score. The change from baseline in weekly mean scores is defined as the post baseline weekly mean score minus the baseline score. Lower scores indicate an improvement. The 6-month AUC was calculated based on change from baseline in weekly mean scores.|Baseline and 6 months|FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.|||score on a scale*week||Inter-Quartile Range|Median
2531537|NCT03338816|Secondary|Annualized Rate of Porphyria Attacks in Participants With AHP|Porphyria attacks were defined as meeting all of the following criteria: an acute episode of neurovisceral pain in the abdomen, back, chest, extremities and/or limbs, no other medically determined cause, and required treatment with intravenous (IV) dextrose or hemin, carbohydrates, or analgesics, or other medications such as antiemetics at a dose or frequency beyond the participant's usual daily porphyria management. The annualized rate of porphyria attacks is a composite endpoint which included porphyria attacks requiring hospitalization, urgent healthcare visit, or IV hemin administration at home.|6 months|Full Analysis Set (FAS): All randomized patients who received at least one dose of study drug.|||annualized attack rate||95% Confidence Interval|Mean
2531538|NCT03338816|Secondary|Annualized Rate of Hemin Administration in Participants With AIP|Annualized rate of hemin doses was evaluated as annualized days of hemin use.|6 months|FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.|||annualized rate of use||95% Confidence Interval|Mean
2531539|NCT03338816|Secondary|The PD Effect of Givosiran on Urine Levels of Porphobilinogen (PBG) in Participants With AIP|The PD effect of givosiran was evaluated by spot urine PBG levels normalized to spot urine creatinine levels.|6 months|FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.|||mmol/mol Cr||Standard Error|Least Squares Mean
2531540|NCT03338816|Secondary|The Pharmacodynamic (PD) Effect of Givosiran on Urine Levels of Delta-aminolevulinic Acid (ALA) in Participants With AIP|The PD effect of givosiran was evaluated by spot urine ALA levels normalized to spot urine creatinine levels.|3 and 6 months|FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.|||mmol/mol creatinine (Cr)||Standard Error|Least Squares Mean
2531599|NCT03334812|Secondary|Change From Baseline in GAG Content|Sodium MRI-based measurements of change from baseline in glycosaminoglycan (GAG) content was assessed from both defective sites and a nearby healthy cartilage region (as a reference tissue). Specifically, the ratio of normalized sodium signal in the surgically created defect (SCD or donor site) to healthy non-weight bearing region (HNWB), i.e. SCD/HNWB was of major interest|Baseline, Week 12 and Week 28|Pharmacodynamic analysis set. Subjects with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.|||Ratio||Standard Error|Least Squares Mean
2531541|NCT03338816|Primary|Annualized Rate of Porphyria Attacks in Participants With Acute Intermittent Porphyria (AIP)|Porphyria attacks were defined as meeting all of the following criteria: an acute episode of neurovisceral pain in the abdomen, back, chest, extremities and/or limbs, no other medically determined cause, and required treatment with intravenous (IV) dextrose or hemin, carbohydrates, or analgesics, or other medications such as antiemetics at a dose or frequency beyond the participant's usual daily porphyria management. The annualized rate of porphyria attacks is a composite endpoint which included porphyria attacks requiring hospitalization, urgent healthcare visit, or IV hemin administration at home.|6 months|AIP participants in the Full Analysis Set (FASAIP): All randomized AIP participants (with identified mutation in the hydroxymethylbilane synthase [HMBS] gene) who received at least one dose of study drug.|||annualized attack rate||95% Confidence Interval|Mean
2531542|NCT03338803|Secondary|Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories|Percentage of adults with T2DM who achieve HbA1c < 7.0% within the 60 to 180 days following initiation of linagliptin across pre-defined renal function categories. Renal function categories were presented based on patients with a pre-index estimated glomerular filtration rate (eGFR) value (eGFR<30, eGFR 30 to 44, eGFR 45 to 59, eGFR 60 to 89, eGFR ≥ 90 milliliter/ minute /1.73 meter^2 and eGFR not available).|60 to 180 days|Patients with a written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.|||Percentage of patients (%)|||Number
2531543|NCT03338803|Secondary|Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across the Pre-defined Age Categories|Percentage of adults with T2DM who achieve HbA1c < 7.0% within the 60 to 180 days following initiation of linagliptin across pre-defined age categories (40 to 54 years, 40 to 54 years, 65 to 74 years and 75+ years).|60 to 180 days|Patients with a written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.|||Percentage of patients (%)|||Number
2531544|NCT03338803|Primary|Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories|"Change in HbA1c among adults with type 2 diabetes mellitus (T2DM) within the 60 to 180 days following initiation of linagliptin across pre-defined renal function categories.~Change in HbA1c, was calculated for each patient by subtracting the patient's last (most recent) HbA1c value during the pre-index period (including the index date) from the patient's last (most recent) HbA1c value 60 to 180 days after the index date. Renal function categories were presented based on patients with a pre-index estimated glomerular filtration rate (eGFR) value (eGFR<30, eGFR 30 to 44, eGFR 45 to 59, eGFR 60 to 89, eGFR ≥ 90 milliliter/ minute/1.73 meter^2 and eGFR not available)."|Baseline and 60 to 180 days|Patients with a written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.|||Percentage (%)||Standard Deviation|Mean
2531545|NCT03338803|Primary|Change in Glycosylated Hemoglobin (HbA1c) Across Age Categories|"Change in HbA1c among adults with type 2 diabetes mellitus (T2DM) within the 60 to 180 days following initiation of linagliptin across pre-defined age categories (40 to 54 years, 40 to 54 years, 65 to 74 years and 75+ years).~Change in HbA1c, was calculated for each patient by subtracting the patient's last (most recent) HbA1c value during the pre-index period (including the index date) from the patient's last (most recent) HbA1c value 60 to 180 days after the index date."|Baseline and 60 to 180 days|Patients with a written prescription for linagliptin were identified during an identification period starting on 01 January 2012 and ending on 30 September 2016.|||Percentage (%)||Standard Deviation|Mean
2531546|NCT03338556|Secondary|Incidence(s) of Laboratory Confirmed Illness|The number of subjects with laboratory confirmed HRV-16 infection (as defined by a positive quantitative polymerase chain reaction (qPCR) result from the combined nasal washes of days 3, 4 and 5) who displayed clinical symptoms of upper respiratory tract (using the 10-item diary card, Day 1 to Day 8) - ITT analysis set|8 days|ITT analysis. Note :Cohort B PrEP-001 active group had n=21 (one less than completed the study n=22)|||participants|||Number
2531547|NCT03338556|Secondary|Area Under Curve of Symptom Scores|"Total symptom scores (from the 10-item modified Jackson symptom diary card) were used to calculate the AUC, from Day 1 (Assessment 1) to Day 8, after challenge, for each subject using the trapezium rule, based on the available non-missing calculated total symptom scores between Day 1 (Assessment 1) and Day 8. The 10-point symptom diary card, measured three times daily was combined to generate total symptom score. The following symptoms in the 10-item symptoms questionnaire were graded on a scale of 0-3, where Grade 0 was absence, Grade 1 was just noticeable, Grade 2 was bothersome but did not prevent participation in activities, and Grade 3 was bothersome and interfered with activities:~Runny nose, Stuffy nose, Sneezing, Sore throat, Earache, Tiredness, Cough, Shortness of breath, Headache, Muscle/joint ache"|8 days|ITT analysis. Note :Cohort B PrEP-001 active group had n=21 (one less than completed the study n=22)|||scores*minutes||Standard Deviation|Mean
2531548|NCT03338556|Primary|Total Symptom Scores|"Overall total symptom score (TSS), defined as the sum of the total symptom scores from day 1 to day 8 inclusive, using the 10-point symptom diary card on a 0 - 3 point scale~The following symptoms in the 10-item symptoms questionnaire were graded on a scale of 0-3, where Grade 0 was absence, Grade 1 was just noticeable, Grade 2 was bothersome but did not prevent participation in activities, and Grade 3 was bothersome and interfered with activities:~Runny nose, Stuffy nose, Sneezing, Sore throat, Earache, Tiredness, Cough, Shortness of breath, Headache, Muscle/joint ache.~Diary cards were filled out 3 times/day on Day 1-7 and once on Day 8. Possible range of outcomes for TSS: 0 - 660 (higher numbers indicating worse outcomes)"|8 days|ITT analysis. Note :Cohort B PrEP-001 active group had n=21 (one less than completed the study n=22)|||units on a scale||Standard Deviation|Mean
2531549|NCT03338400|Secondary|Pain Level|numerical pain scale ranges from 0 to 10, where lower scores represent less pain.|24 hours|||||||
2531550|NCT03338400|Secondary|Readmissions|Any patient that is re-admitted to the hospital and the reason for re-admission will be collected.|6 weeks|||||||
2531551|NCT03338400|Secondary|Urinary Tract Infections||until 6 weeks|||||||
2531552|NCT03338400|Secondary|Nausea, Vomiting|"Patients will be administered a postoperative nausea, vomiting scale. The Post Operative Nausea Scale ranges from 0 to 77, where lower scores are improved outcomes."|24 hrs|||||||
2531703|NCT03333577|Primary|Patient Satisfaction Survey|To evaluate patient experience when using the Baha SoundArc after a one month take-home trial, compared to the existing Baha Softband on the Participant Take Home questionnaire (strongly agree, Agree, Neutral, disagree, strongly disagree)|one month post fitting||||percentage of satisfied subjects|||Number
2531553|NCT03338400|Primary|Questionnaire: Quality of Recovery 40|The primary aim is to evaluate whether standard administration of Dexamethasone at the time of anesthesia induction in patients undergoing vaginal reconstructive surgery would result in improved Quality of Recovery. The QoR-40 has 40 items that consider early postoperative health status of patients. These items cover five dimensions including emotional state (9 items), physical comfort (12 items), patient support (7 items), physical independence (5 items) and pain (7 items). All items are rated on a five-point Likert scale from one (worst) to five (best). All negative items were reversed to ease the interpretation. The total score (global score) was computed by summing all items. The minimum and maximum possible scores were 40 and 200, respectively.|24 hours||||score on a scale||Standard Deviation|Mean
2531554|NCT03337477|Primary|Mean Absolute Change in S-K From Baseline Until 4h After Start of Dosing With SZC/Placebo|The least squares means (LS-means) are derived from a linear regression model of absolute change in S-K at 4h with the following covariates: treatment group; baseline S-K; time from the start of dosing insulin to the start of dosing SZC/placebo and the dose (units/kg) of the first course of insulin. The 95% CI is associated with LS-Means.|Baseline to 4h potassium measurements.|Full analysis set: all randomized patients. However, patients with no baseline or/and post-baseline data (one patient in each group) were excluded from the analysis.|||mmol/L||95% Confidence Interval|Least Squares Mean
2531555|NCT03337477|Secondary|Mean Absolute Change in S-K From Baseline to 1h and 2h After Start of Dosing With SZC/Placebo|The least squares means (LS-means) are derived from a linear regression model of absolute change in S-K at 1h and 2h with the following covariates: treatment group; baseline S-K; time from the start of dosing insulin to the start of dosing SZC/placebo and the dose (units/kg) of the first course of insulin. The 95% CI is associated with LS-Means.|Baseline to 2h potassium measurements.|Full analysis set: all randomized patients. However, patients with no baseline or/and post-baseline data (one patient in each group) were excluded from the analysis.|||mmol/L||95% Confidence Interval|Least Squares Mean
2531556|NCT03337477|Secondary|The Fraction of Patients Administered Additional Potassium Lowering Therapy Due to Hyperkalaemia From 0 to 4h.|Additional therapies for hyperkalaemia are 2nd dose of insulin, Beta-agonists, Diuretics, Dialysis, Sodium bicarbonate and Potassium binders when administered with the expressed intent to lower S-K.|Baseline to 4h potassium meansurements.|Full analysis set: all randomized patients. However, patients with no baseline or/and post-baseline data (one patient in each group) were excluded from the analysis.|||Proportion of participants|||Number
2531557|NCT03337477|Secondary|The Fraction of Patients Achieving S-K <6.0mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo||Baseline to 4h potassium meansurements.|Full analysis set: all randomized patients. However, patients with no baseline or/and post-baseline data (one patient in each group) were excluded from the analysis.|||Proportion of paticipants|||Number
2531558|NCT03337477|Secondary|The Fraction of Patients Achieving S-K <5.5mmol/l 1, 2, and 4h After Start of Dosing With SZC/Placebo||Baseline to 4h potassium meansurements.|Full analysis set: all randomized patients. However, patients with no baseline or/and post-baseline data (one patient in each group) were excluded from the analysis.|||Proportion of paticipants|||Number
2531559|NCT03337477|Secondary|The Fraction of Patients Achieving Normokalaemia 1, 2 and 4h After Start of Dosing With SZC/Placebo|Proportion of patients achieving normokalaemia, S-K 3.5-5.0 mmol/L, at 1, 2 and 4h after start of dosing|Baseline to 4h potassium meansurements.|Full analysis set: all randomized patients. However, patients with no baseline or/and post-baseline data (one patient in each group) were excluded from the analysis.|||Proportion of participants|||Number
2531560|NCT03337477|Secondary|Fraction of Patients Responding to Therapy Defined as: S-K <6.0mmol/L Between 1 and 4h and S-K <5.0mmol/L at 4h; and no Additional Potassium Lowering Therapy From 0 to 4h With Exception of the Initial Insulin Treatment|Additional therapies for hyperkalaemia are 2nd dose of insulin, Beta-agonists, Diuretics, Dialysis, Sodium bicarbonate and Potassium binders when administered with the expressed intent to lower S-K. Patients with any missing potassium value from 1h to 4h inclusive will be treated as non-responders.|Baseline to 4h potassium meansurements.|Full analysis set: all randomized patients. However, patients with no baseline or/and post-baseline data (one patient in each group) were excluded from the analysis.|||Proportion of participants|||Number
2531561|NCT03337308|Secondary|Percent Change From Baseline to Week 12 in Triglycerides (TGs)|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TGs. Baseline was defined as the mean of the TGs values from Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: ([TGs value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100.|Baseline; Week 12|FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed.|||Percent change||Standard Deviation|Mean
2531562|NCT03337308|Secondary|Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C)|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for HDL-C. Baseline was defined as the mean of the HDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: ([HDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100.|Baseline; Week 12|FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed.|||Percent change||Standard Deviation|Mean
2531563|NCT03337308|Secondary|Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B)|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apo B. Baseline was defined as the predose Day 1/Week 0 value. Percent change from baseline in apo B was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline apo B as a covariate. Percent change from baseline was calculated as: ([apo B value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100.|Baseline; Week 12|FAS. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed. Only participants with available data were analyzed.|||Percent change||Standard Error|Least Squares Mean
2539483|NCT03070730|Secondary|Change in Physical Functioning-EuroQOL From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the EuroQOL.|1 week after second intervention|||||||
2531564|NCT03337308|Secondary|Percent Change From Baseline to Week 12 in Total Cholesterol (TC)|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the mean of the TC values from Week -2 and predose Day 1/Week 0. Percent change from baseline in TC was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline TC as a covariate. Percent change from baseline was calculated as: ([TC value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100.|Baseline; Week 12|FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed.|||Percent change||Standard Error|Least Squares Mean
2531565|NCT03337308|Secondary|Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for non-HDL-C. Baseline was defined as the mean of the non-HDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in non-HDL-C was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline non-HDL-C as a covariate. Percent change from baseline was calculated as: ([non-HDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100.|Baseline; Week 12|FAS. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed.|||Percent change||Standard Error|Least Squares Mean
2531566|NCT03337308|Secondary|Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the predose Day 1/Week 0 value. Percent change from baseline in hsCRP was analyzed using a non-parametric analysis. Percent change from baseline was calculated as: ([hsCRP value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100.|Baseline; Week 12|FAS. Only participants with available data were analyzed. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice;therefore, analysis was completed with all efficacy data from these sites removed.|||Percent Change||Inter-Quartile Range|Median
2531567|NCT03337308|Primary|Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the LDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group and randomization stratification as a factors and baseline LDL-C as a covariate. Percent change from baseline was calculated as: ([LDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. For LDL-C, if measured LDL-C value was available, measured LDL-C was used.|Baseline; Week 12|Full Analysis Set (FAS), also known as the intention-to-treat set, was defined as all randomized participants. After a Root Cause Analysis, three sites were found not to have followed Good Clinical Practice; therefore, analysis was completed with all efficacy data from these sites removed.|||Percent Change||Standard Error|Least Squares Mean
2531568|NCT03336853|Primary|Change From Baseline in Root Canal Bleeding|"After the root canal, shaping was performed a first sterile paper point was introduced in the root canal, up to the working length, to detect blood presence.~The millimeters of blood on the paper point were measured with a caliber. After the intervention (HybenX or placebo) a second sterile paper point was introduced in the root canal, up to the working length, to detect the presence of blood according the previous criteria"|Baseline and After Treatment (20 seconds)||||millimeters|teeth|Standard Deviation|Mean
2531569|NCT03336502|Secondary|Participants With Invasive Fungal Infection (IFI)|Number of participants with possible, probable, or proven IFI observed during the whole study period|Up to 28 days|All participants who received at least one dose of study drug.|||Participants|||Number
2531570|NCT03336502|Secondary|Survival Status|Survival assessment as to whether a participant is alive or dead, included all participants who died - 2 during study treatment, 1 during safety follow-up, 2 during survival follow-up (Day 60 to 70 post dose), and 1 participant who died during serious AE (SAE) follow-up at 97 days after first dose but was beyond the safety and the survival follow-up period|Up to 98 days|All participants who received at least one dose of study drug.|||Participants|||Number
2531571|NCT03336502|Secondary|Medically Significant Changes in Clinical Laboratory Results - Vital Signs|The number of participants with values of vital signs outside of normal range|Up to 28 days|All evaluable participants in Subgroup 1 (Serial PK) and Subgroup 2 (Sparse PK) not yet switched to oral suspension. Both groups received the same dose and drug administration and reflect only different blood sampling schedules.|||Participants|||Number
2531572|NCT03336502|Secondary|Medically Significant Changes in Clinical Laboratory Results - Lab Values|The number of participants with clinical laboratory values outside of normal range|Up to 28 days|All evaluable participants in Subgroup 1 (Serial PK) and Subgroup 2 (Sparse PK) not yet switched to oral suspension. Both groups received the same dose and drug administration and reflect only different blood sampling schedules.|||Participants|||Number
2531573|NCT03336502|Secondary|Discontinuations Due to an AE|Number of participants discontinued from study medication due to an AE where AEs are defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.|Up to 28 days|All participants who received at least one dose of study drug.|||Participants|||Number
2531574|NCT03336502|Secondary|Adverse Events (AEs)|Number of participants with one or more AEs where AEs are defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.|Up to 58 days|All participants who received at least one dose of study drug.|||Number of Participants|||Number
2531575|NCT03336502|Primary|POS Plasma Trough Concentrations in the Serial PK and Sparse PK Subgroups|Pre-dose plasma trough concentrations by study day between serial PK and Sparse PK - where serial PK is defined as multiple serial blood sampling of more than 6 timepoints; and sparse PK is defined as few blood samples taken and single or limited timepoints|Day 3, Day 6, Day 10, Day 15, Day 22, Day 28|"All evaluable participants in Subgroup 1 (Serial PK) and Subgroup 2 (Sparse PK) not yet switched to oral suspension.~Both groups received the same dose and drug administration and reflect only different blood sampling schedules."|||ng/mL||Standard Deviation|Mean
2531576|NCT03336502|Primary|Total Body Clearance (CL) of POS of Serial PK (Subgroup 1) on Day 10|"Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. CL is defined as the time it takes for POS to be completely removed from the body's blood stream.~Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.~Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only."|Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI|Analysis population includes participants who had serial blood draws on Day 10. Sparse PK (subgroup 2) is not included in this analysis because blood was drawn only once on Day 10 for plasma trough determination.|||mL/hr||Standard Deviation|Mean
2531577|NCT03336502|Primary|Time to Steady-state Maximum Concentration (ssTmax) of POS of Serial PK (Subgroup 1) on Day 10|"Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Tmax is defined as the time it takes to achieve maximum concentration of POS in plasma.~Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.~Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only."|Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI|Analysis population includes participants who had serial blood draws on Day 10. Sparse PK (subgroup 2) is not included in this analysis because blood was drawn only once on Day 10 for plasma trough determination.|||hr||Standard Deviation|Mean
2531578|NCT03336502|Primary|Steady State Minimum Concentration (ssCmin) of POS of Serial PK (Subgroup 1) on Day 10|"Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Cmin is defined as the minimum concentration of POS in plasma.~Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.~Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only."|Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI|Analysis population includes participants who had serial blood draws on Day 10. Sparse PK (subgroup 2) is not included in this analysis because blood was drawn only once on Day 10 for plasma trough determination.|||ng/mL||Standard Deviation|Mean
2531579|NCT03336502|Primary|Steady State Maximum Concentration (ssCmax) of POS of Serial PK (Subgroup 1) on Day 10|"Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Cmax is defined as the maximum concentration of POS in plasma.~Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.~Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only."|Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI|Analysis population includes participants who had serial blood draws on Day 10. Sparse PK (subgroup 2) is not included in this analysis because blood was drawn only once on Day 10 for plasma trough determination.|||ng/mL||Standard Deviation|Mean
2531580|NCT03336502|Primary|Steady-state Area Under the Concentration-time Curve (ssAUC0-24hr) of POS of Serial PK (Subgroup 1) on Day 10|"Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. AUC0-24 is defined as area under the plasma concentration-time curve from time 0 extrapolated to 24 hours.~Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.~Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only."|Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI|Analysis population includes participants who had serial blood draws on Day 10. Sparse PK (subgroup 2) is not included in this analysis because blood was drawn only once on Day 10 for plasma trough determination.|||hr*ng/mL||Standard Deviation|Mean
2531581|NCT03336502|Primary|Percentage of Participants With ssCavg ≥500 ng/mL of Serial PK (Subgroup 1) on Day 10|"Characterization of the PK parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Steady-state Cavg, where Cavg is defined as AUC0-24hr divided by the dosing interval. The percentage of participants with ssCavg ≥500 ng/mL are presented.~Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.~Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only."|Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI|Analysis population includes participants who had serial blood draws on Day 10. Sparse PK (subgroup 2) is not included in this analysis because blood was drawn only once on Day 10 for plasma trough determination.|||Percentage of Participants|||Number
2531600|NCT03334812|Secondary|Percentage of Donor Site Refilling Based on MRI Measurements.|Extent of filling of the donor site over a longer term. Percentage change from baseline in refilling of cartilage defect based on 7T MRI for donor Region.|Baseline, Week 4, Week 12 and Week 28|Pharmacodynamic analysis set. Subjects with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.|||Percent||Standard Error|Least Squares Mean
2531682|NCT03334214|Secondary|Percent Change in Liver Volume|Assessed from Baseline MRI to Post-Treatment MRI.|Baseline to Week 15|The per protocol set included all randomized participants who received at least 10 of the prescribed doses and received the first 4 doses in the first 5 weeks, not missing 3 consecutive weekly doses and having no significant protocol deviations.|||percent change||Standard Deviation|Mean
2531582|NCT03336502|Primary|Steady State (ss) Average Concentration (Cavg) of Posaconazole of Serial PK (Subgroup 1) on Day 10|"Characterization of the pharmacokinetics (PK) parameters of POS determined from plasma samples taken at steady-state after receiving IV administration of 300 mg POS twice a day (BID) on Day 1 and then 300 mg POS QD until at least Day 10. Steady-state Cavg, where Cavg is defined as AUC0-24hr divided by the dosing interval.~Subgroup 1 - Serial PK, multiple same-day blood draw, performed specifically for determination of PK parameters of Cavg, AUC, Cmin, Cmax, Tmax and Total Body Clearance in addition to plasma trough determination.~Subgroup 2 - Sparse PK, once a day blood draw, performed for plasma trough determination only."|Serial PK (Subgroup 1) on Day 10 at pre-dose, 1 hr. post start of infusion (SOI), end of infusion (EOI), 15 min. after EOI and 4, 8, 12, 24 hours post SOI|Analysis population includes participants who had serial blood draws on Day 10. Sparse PK (subgroup 2) is not included in this analysis because blood was drawn only once on Day 10 for plasma trough determination.|||ng/mL||Standard Deviation|Mean
2531583|NCT03335800|Secondary|Self-reported Contact With a Health Care Provider|Percentage of participant who self-reported contact with a health care provider within 90 days following an irregular pulse watch notification. Participants could self-report this health-care provider contact from 90 days following notification until the study survey went offline at end of study.|90 days to 15 months||||Percentage of participants||95% Confidence Interval|Number
2531584|NCT03335800|Secondary|Concordant AF With App Algorithm Notification|Simultaneous ambulatory ECG monitoring indicating an irregular rhythm consistent with AF when the app based algorithm is positive for an irregular pulse among those who received a notification.|During ambulatory ECG monitoring (up to 8 days)||||Proportion of Participants||95% Confidence Interval|Number
2531585|NCT03335800|Primary|Confirmed AF With a Detection by a Component of the App|Simultaneous ambulatory ECG monitoring indicating an irregular rhythm consistent with AF during time intervals when an app component (tachogram) is positive for an irregular pulse among those who received an irregular heartbeat notification.|During ambulatory ECG monitoring (up to 8 days)||||Proportion of Tachograms with AF|Tachograms|97.5% Confidence Interval|Number
2531586|NCT03335800|Primary|Atrial Fibrillation (AF) of Greater Than 30 Seconds|Proportion of notified participants who received an irregular pulse notification and that had AF detected on the ambulatory ECG.|During ambulatory ECG monitoring (up to 8 days)|Participant who returned ECG Patch|||Proportion of participants||97.5% Confidence Interval|Number
2531587|NCT03335566|Secondary|Percentage of Participants With Accuracy Improvement in Post-contrast Versus Pre-contrast Ultrasound Examination for Lesion-Specific Diagnoses of the Target Lesion Against the Reference Diagnosis/Standard of Truth|The accuracy improvement was calculated by the number of participants with improved diagnoses from the pre-contrast diagnosis to the post-contrast diagnosis divided by the total number of participants, multiplied by 100. Assessment was performed by 3 blinded readers.|Pre-administration up to 15 minutes post-administration|Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.|||percentage of participants|||Number
2531588|NCT03335566|Secondary|Number of Participants With Diagnostic Confidence (Evaluated by Blinded Readers) in Pre-Contrast and Post-Contrast Ultrasound Examination Results|Confidence in diagnoses from the pre- and post-contrast ultrasound examinations was evaluated based on 4-point scale: 0-Unknown (cannot make a judgement on level of confidence), 1- Not confident (another examination was required), 2- Probable (Would have more confidence if another diagnostic imaging test such as MRI or CT was performed), 3- Definite (Sufficient confidence to the extent that another diagnostic imaging test such as MRI or CT was unnecessary).|Pre-administration up to 15 minutes post-administration|Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.|||Participants|||Count of Participants
2531589|NCT03335566|Secondary|Number of Lesions Detected by Post-Contrast US Relative to Number of Lesions Detected by Pre-Contrast US (Both by Blinded Readers[BR]) and Number of Lesions Detected by Post-Contrast US (by BR) Relative to Number of Lesions Detected by RD (Investigators)|For the cases that can be assessed by the blinded readers both pre- and post-contrast, differences were calculated between the Sonazoid™ and SonoVue® groups in the number of lesions detected during whole-liver imaging (post-contrast minus pre-contrast). The differences were also calculated between the Sonazoid™ and SonoVue® groups in the number of lesions (post-contrast minus reference diagnosis) detected during whole-liver imaging.|Pre-administration up to 15 minutes post-administration|Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.|||Lesions||Inter-Quartile Range|Median
2531590|NCT03335566|Primary|Percentage of Participants With Accuracy Improvement in Post-Contrast Versus Pre-Contrast Ultrasound (US) Examination for Diagnosis of the Target Lesion as Malignant or Benign Against the Reference Diagnosis (RD)/Standard of Truth|Accuracy improvement was calculated by the number of participants with improved diagnoses from the pre-contrast diagnosis to the post-contrast diagnosis divided by the total number of participants, multiplied by 100. Assessments were done by 3 blinded readers. Efficacy population which included all participants who received Sonazoid™ or SonoVue®, for whom pre-contrast & post-contrast images were recorded, & for whom there was a reference standard contrast-enhanced computed tomography (CECT)/contrast-enhanced magnetic resonance imaging (CE-MRI) examination or biopsy.|Pre-administration up to 15 minutes post-administration|Analysis was performed on efficacy population. Here, number analysed=participants with available data for specified category.|||percentage of participants|||Number
2531591|NCT03335254|Primary|Percentage of Responders Based on Measured Total Testosterone (Cavg).|TSX-011 responders are defined as study subjects who are able to achieve a Cavg serum total testosterone > 350 ng/dL. The percentage of responders is recorded for each treatment group within each period.|Period 1: Up to 13 days. Period 2: 15 days. Period 3: 15 days.|Arm 2 to Arm 20 have zero participants due to dose adjustment based on the total testosterone levels presented.|||percentage of participants|||Number
2531592|NCT03334825|Secondary|Number of Participants With HIV Viral Suppression|Last viral load is under 200 copies/mL|12 months post-enrollment|persons who survived 12 months post-enrollment|||Participants|||Count of Participants
2531593|NCT03334825|Secondary|Number of Participants With Engagement in HIV Care|any reported HIV viral load (VL) or CD4 test|12 months post-enrollment|persons who survived 12 months post-enrollment|||Participants|||Count of Participants
2539484|NCT03070730|Secondary|Change in Physical Functioning-EuroQOL From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the EuroQOL.|1 week after first intervention|||||||
2531601|NCT03334812|Secondary|Change From Baseline in International Cartilage Repair Society (ICRS) Scoring|Extent of the repair tissue at the donor site before surgery. Each criterion was evaluated based on the visual analog scale and graded from 0 (best) to 100 (worst).|Week 4|Pharmacodynamic analysis set. Subjects with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.|||Unit on a scale||Standard Error|Mean
2531602|NCT03334812|Primary|Bi-layer Collagen Organization Based on MRI Measurements|MRI T2 maps were generated and zonal T2 ratios (superficial layer T2 / deep layer T2) were calculated to assess the collagen fiber organization in the surgically created defect (SCD) and defect to be treated (DTBT) cartilage regions.|Week 4|Pharmacodynamic analysis set. Subjects with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.|||Ratio||Standard Error|Mean
2531603|NCT03334812|Primary|Change From Baseline in GAG Content|Sodium MRI-based measurements of change from baseline in glycosaminoglycan (GAG) content were assessed from both defective sites and a nearby healthy cartilage region (as a reference tissue). Specifically, the ratio of normalized sodium signal in the surgically created defect (SCD or donor site) to healthy non-weight bearing region (HNWB), i.e. SCD/HNWB and the defect to be treated (DTBT or main lesion) to healthy weight bearing region (HWB), i.e. DTBT/HWB was of major interest|Baseline, Week 4|Pharmacodynamic analysis set. Subjects with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.|||Ratio||Standard Error|Least Squares Mean
2531604|NCT03334734|Secondary|Elimination Constant (Kel) of PBTZ169|Apparent terminal elimination rate constant was evaluated based on the regressional dependence of log-transformed concentrations ln(C) on time for the terminal log- linear part of the concentration-time curve.|72 hours after the last drug administration|PKA|||1/h||Standard Deviation|Mean
2531605|NCT03334734|Secondary|Elimination Constant (Kel) of PBTZ169|Apparent terminal elimination rate constant was evaluated based on the regressional dependence of log-transformed concentrations ln(C) on time for the terminal log- linear part of the concentration-time curve.|24 hours after the first drug administration|PKA|||1/h||Standard Deviation|Mean
2531606|NCT03334734|Secondary|Plasma Half-life Time (T1/2) of PBTZ169||24 hours after the last drug administration|PKA|||h||Standard Deviation|Mean
2531607|NCT03334734|Secondary|Plasma Half-life Time (T1/2) of PBTZ169||24 hours after the fist drug administration|PKA|||h||Standard Deviation|Mean
2531608|NCT03334734|Secondary|Volume of Distribution (Vd) of PBTZ169|Distribution volume Vd for a dosing interval of 72 hours after the last dose|Up to 72 hours after the last drug administration|PKA|||L||Standard Deviation|Mean
2531609|NCT03334734|Secondary|Total (Plasma) Clearance (Clt) of PBTZ169|"Clt/F (apparent total clearance following single and multiple oral administration) was calculated using the following formula:~Cl_t/F=D/AUC where D is the daily dose of the drug."|24 hours after the last drug administration|PKA|||L/h||Standard Deviation|Mean
2531610|NCT03334734|Secondary|Total (Plasma) Clearance (Clt) of PBTZ169|"Clt/F (apparent total clearance following single and multiple oral administration) was calculated using the following formula:~Cl_t/F=D/AUC where D is the daily dose of the drug."|24 hours after the first drug administration|PKA|||L/h||Standard Deviation|Mean
2531611|NCT03334734|Secondary|Fluctuations (%) in the Dosing Interval|Fluctuations (%) in the dosing interval after multiple dosing ((Cmax - Cmin) × 100%/Css,av)|Up to 72 hours after the last drug administration|PKA|||% (ratio)||Standard Deviation|Mean
2531612|NCT03334734|Secondary|Average Concentration (Css,av) of PBTZ169|Average steady-state concentration in the dosing interval following multiple dosing was evaluated as the ratio AUC0 24/τ (τ = the dosing interval)|Up to 72 hours after the last drug administration|PKA|||ng/ml||Standard Deviation|Mean
2531613|NCT03334734|Secondary|Accumulation Ratios for the PK Parameters AUC(0 -24)|Accumulation ratios for the PK parameter AUC(0 -24): AUC(0- 24,ss)/AUC(0 -24), Day 1, on the original scale|24 hours after the first and the last drug administration|PKA|||ratio||90% Confidence Interval|Geometric Mean
2531614|NCT03334734|Secondary|AUC(0-∞) of PBTZ169|Area under the plasma concentration versus time curve in frames [0-∞]|Up to 72 hours after the last drug administration|PKA|||ng*h/ml||Standard Deviation|Mean
2531615|NCT03334734|Secondary|AUC (0-t)|Area under the plasma concentration of PBTZ169 versus time curve in frames [0-last concentration above lower limit of quantification (LLoQ)]|Up to 72 hours after the last drug administration|PKA|||ng*h/ml||Standard Deviation|Mean
2531616|NCT03334734|Secondary|AUC(0-24)|Area under the plasma concentration of PBTZ169 versus time curve in frames [0-24 hours] for the last dosing (Day 14)|Up to 24 hours after the last drug administration|PKA|||ng*h/ml||Standard Deviation|Mean
2531617|NCT03334734|Secondary|Peak Plasma Concentration (Сmax) of PBTZ169|Peak plasma concentration (Сmax) of PBTZ169: concentration measurement following single dosing|for single dosing , Day 1 (24 h after 1st dose of PBTZ169)|PKA: the pharmacokinetic analysis population for multiple dosing comprised all patients participating in the PK study who had received at least one dose of the study drug PBTZ169, provided that data on study drug concentration (with at least one measurement above BLQ) was available.|||ng/ml||Standard Deviation|Mean
2531618|NCT03334734|Secondary|AUC(0-24)|Area under the plasma concentration of PBTZ169 versus time curve in frames [0-24 hours]|Up to 24 hours after the first drug administration|PKA|||ng*h/ml||Standard Deviation|Mean
2531619|NCT03334734|Secondary|Time to Reach Maximum Concentration (Tmax) of PBTZ169|Time to reach maximum concentration (Tmax) of PBTZ169 after multiple oral administration in different doses|Up to 72 hours after the last drug administration|PKA|||h||Full Range|Median
2531620|NCT03334734|Secondary|Time to Reach Maximum Concentration (Tmax) of PBTZ169|Time to reach maximum concentration (Tmax) of PBTZ169 after single oral administration in different doses|for single dosing , Day 1 (24 h after 1st dose of PBTZ169)|PKA|||h||Full Range|Median
2531621|NCT03334734|Secondary|Minimal Plasma Concentration (Сmin) of PBTZ169|Minimal plasma concentration (Сmin) of PBTZ169: multiple dosing|Up to 72 hours after the last drug administration|PKA|||ng/ml||Standard Deviation|Mean
2531622|NCT03334734|Secondary|Residual Concentration (Ctrough) of PBTZ169|Residual concentration (Ctrough) of PBTZ169, measured 24 hours after the first dose administration, prior to the last dose, and 24 hours after the last dose|Up to 72 hours after the last drug administration|PKA|||ng/ml||Standard Deviation|Mean
2547321|NCT02908516|Primary|Change in Hemoglobin Level||From presentation until postoperative day 3|Data were not collected post surgery due to study termination.||||||
2531624|NCT03334734|Secondary|Peak Plasma Concentration (Сmax) of PBTZ169|Peak plasma concentration (Сmax) of PBTZ169 for multiple dosing|Up to 72 hours after the last drug administration|PKA: the pharmacokinetic analysis population for multiple dosing comprised all patients participating in the PK study who had received at least one dose of the study drug PBTZ169, provided that data on study drug concentration (with at least one measurement above BLQ) was available.|||ng/ml||Standard Deviation|Mean
2531625|NCT03334734|Secondary|Early Bactericidal Activity (0-7)|EBA (0-7): PCR, the mean of two measurements at the Visit|7 days after the onset of monotherapy|FAS|||cell count per 1 mL of sputum||Standard Deviation|Mean
2531626|NCT03334734|Secondary|Early Bactericidal Activity (0-2)|EBA (0-2): PCR, the mean of two measurements at the Visit|2 days after the onset of monotherapy|FAS|||cell count per 1 mL of sputum||Standard Deviation|Mean
2531627|NCT03334734|Secondary|Early Bactericidal Activity (0-7)|EBA (0-7): agar inoculation, the mean of two measurements at the Visit|7 days after the onset of monotherapy|FAS|||CFU per 1 mL of sputum||Standard Deviation|Mean
2531628|NCT03334734|Secondary|Early Bactericidal Activity (0-2)|EBA (0-2): agar inoculation, the mean of two measurements at the Visit|2 days after the onset of monotherapy|FAS|||CFU per 1 mL of sputum||Standard Deviation|Mean
2531629|NCT03334734|Primary|Early Bactericidal Activity (0-14)|Early bactericidal activity 14 days from the monotherapy start date (EBA 0-14): PCR, the mean of two measurements at the Visit|14 days after the onset of monotherapy|FAS|||cell count per 1 mL of sputum||Standard Deviation|Mean
2531630|NCT03334734|Primary|Early Bactericidal Activity (0-14)|Early bactericidal activity 14 days from the monotherapy start date (EBA 0-14): agar inoculation, the mean of two measurements at the Visit|14 days after the onset of monotherapy|FAS|||CFU per 1 mL of sputum||Standard Deviation|Mean
2531631|NCT03334422|Secondary|Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement|The IGA measures the investigator's global assessment of the participants overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.|4 Weeks|All randomized participants.|||percentage of participants|||Number
2531632|NCT03334422|Secondary|Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)|"EQ-5D-5L is a 2-part measurement. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.~LSMean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, & treatment-by-visit-interaction as fixed categorical effects. Baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with week 16 EQ-5D-5L VAS data.|||Millimeter (mm)||Standard Error|Least Squares Mean
2531633|NCT03334422|Secondary|Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm|"EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.~LSMean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, & treatment-by-visit-interaction as fixed categorical effects. Baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with week 16 EQ-5D-5L health state index US & UK data.|||units on a scale||Standard Error|Least Squares Mean
2531634|NCT03334422|Secondary|Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire|The WPAI-AD participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, with higher values indicating greater impairment. LSMean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, & treatment-by-visit-interaction as fixed categorical effects. Baseline and baseline-by-visit-interaction as fixed continuous effects.|Baseline, 16 Weeks|All randomized participants with week 16 WPAI-AD data.|||units on a scale||Standard Error|Least Squares Mean
2531635|NCT03334422|Secondary|Change From Baseline on the Dermatology Life Quality Index (DLQI)|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last week. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Scores range from 0 to 30 (less to more impairment), and a 4-point change from baseline is considered as the minimal clinically important difference threshold.~LSMean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, & treatment-by-visit-interaction as fixed categorical effects. Baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with week 16 DLQI data.|||units on a scale||Standard Error|Least Squares Mean
2531636|NCT03334422|Secondary|Change From Baseline on the Hospital Anxiety and Depression Scale (HADS)|"The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 items questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.~LSMean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, & treatment-by-visit-interaction as fixed categorical effects. Baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with Week 16 HADS data.|||units on a scale||Standard Error|Least Squares Mean
2532722|NCT03294629|Primary|Compliance of Auto-CPAP Therapy|Objective data recorded in the auto-CPAP machine, Percentage of nights of using auto-CPAP for at least 4 hours during therapy.|2 weeks||||percentage of nights||Standard Deviation|Mean
2531637|NCT03334422|Secondary|Change From Baseline in the Patient Global Impression of Severity—Atopic Dermatitis (PGI-S-AD) Score|"The PGI-S-AD asked the participant to evaluate the severity of the disease at that point in time on a single-item, 5-point scale, using a daily diary. The same category labels used in the Physician's Global Assessment were used for the PGI-S-AD, ie, (0) no symptoms, (1) very mild, (2) mild (3) moderate, and (4) severe. LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with Week 16 PGI-S-AD data.|||units on a scale||Standard Error|Least Squares Mean
2531638|NCT03334422|Secondary|Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)|"The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life.~LSMean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, & treatment-by-visit-interaction as fixed categorical effects. Baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with week 16 POEM data.|||units on a scale||Standard Error|Least Squares Mean
2531639|NCT03334422|Secondary|Percent Change From Baseline in Itch NRS|"The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.~LSMean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, & treatment-by-visit-interaction as fixed categorical effects. Baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with week 16 Itch NRS data.|||Percent Change||Standard Error|Least Squares Mean
2531640|NCT03334422|Secondary|Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment|Percentage of participants developing skin infections requiring antibiotic treatment.|16 Weeks|All randomized participants.|||Percentage of participants|||Number
2531641|NCT03334422|Secondary|Change From Baseline in Body Surface Area (BSA) Affected|"Body surface area affected by AD will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage will be reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions.~Use the percentage of skin affected for each region (0 to 100%) in EASI as follows:~BSA Total = 0.1*BSAhead and neck + 0.3*BSAtrunk + 0.2* BSAupper limbs + 0.4*BSAlower limbs.~LSMean were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with Week 16 BSA data.|||unit on a scale||Standard Error|Median
2531642|NCT03334422|Secondary|Percentage of Participants Achieving SCORAD90|"The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.~SCORAD90 defined as a ≥ 90% improvement from baseline in the SCORAD score."|16 Weeks|All randomized participants.|||percentage of participants|||Number
2531643|NCT03334422|Secondary|Change From Baseline in SCORAD|The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. LSMeans was calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, & treatment-by-visit-interaction as fixed categorical effects. Baseline and baseline-by-visit-interaction as fixed continuous effects.|Baseline, 16 Weeks|All randomized participants with a Week 16 SCORAD data.|||units on a scale||Standard Error|Least Squares Mean
2531644|NCT03334422|Secondary|Percentage of Participants Achieving IGA of 0|The IGA measures the investigator's global assessment of the participants overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.|16 Weeks|All randomized participants.|||percentage of participants|||Number
2531645|NCT03334422|Secondary|Percentage of Participants Achieving EASI50|The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs (1) erythema, (2)edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI 50 is defined as ≥50% improvement from baseline in EASI score.|16 Weeks|All randomized participants.|||percentage of participants|||Number
2531860|NCT03328208|Other Pre-specified|Anxiety at the End of the Waiting Room Time (Change as Compared to Beginning of the Waiting Room Time)|Anxiety as measured by self-report on a 0-10 scale with 0=no anxiety at all and 10=worst anxiety possible; change from the beginning to the end of the waiting room time|Up to 60 min||||units on a scale||95% Confidence Interval|Mean
2531646|NCT03334422|Secondary|Change From Baseline in Skin Pain NRS|"Skin Pain NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing no pain and 10 representing worst pain imaginable. Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours.~LSMean was calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with a Week 16 Skin Pain NRS data.|||units on a scale||Standard Error|Least Squares Mean
2531647|NCT03334422|Secondary|Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)|"Atopic Dermatitis Sleep Scale (ADSS) is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep last night. Item 2, frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times, where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep last night. Each item is scored individually.~LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with a Week 16 ADSS Item 2 (frequency of waking) data.|||units on a scale||Standard Error|Least Squares Mean
2531648|NCT03334422|Secondary|Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)|"The Itch Numeric Rating Scale (NRS) is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours."|16 Weeks|All randomized participants with a baseline Itch NRS score ≥ 4.|||percentage of participants|||Number
2531649|NCT03334422|Secondary|Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)|The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable Itching or lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.|16 Weeks|All randomized participants.|||percentage of participants|||Number
2531650|NCT03334422|Secondary|Percent Change From Baseline on EASI Score|"The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs (1) erythema (2)edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score is obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).~Least Square (LS) Means were calculated using a mixed model repeated measures (MMRM) model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants who had a week 16 EASI data.|||Percent Change||Standard Error|Least Squares Mean
2531651|NCT03334422|Secondary|Percentage of Participants Achieving EASI90|The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (1) erythema, (2)edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score is obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score.|16 Weeks|All randomized participants|||percentage of participants|||Number
2531652|NCT03334422|Secondary|Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)|The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score is obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.|16 Weeks|All randomized participants.|||percentage of participants|||Number
2531653|NCT03334422|Secondary|Percentage of Participants Achieving IGA of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 1mg Baricitinib)|The IGA measures the investigator's global assessment of the participants overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.|16 Weeks|All participants randomized to placebo or 1mg of study drug.|||percentage of participants|||Number
2531654|NCT03334422|Primary|Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2mg and 4mg Baricitinib)|The IGA measures the investigator's global assessment of the participants overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.|16 Weeks|All participants randomized to placebo, 2mg, or 4mg of study drug.|||percentage of participants|||Number
2547322|NCT02908516|Primary|Total Blood Loss||Postoperative day 3|Data were not collected post surgery due to study termination.||||||
2531655|NCT03334396|Secondary|Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement|The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.|4 Weeks|All randomized participants.|||percentage of participants|||Number
2531656|NCT03334396|Secondary|Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Score (VAS)|"EQ-5D-5L is a 2-part measurement. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.~LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with Week 16 EQ-5D-5L VAS data.|||millimeters||Standard Error|Least Squares Mean
2531657|NCT03334396|Secondary|Change From Baseline on the European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm|"EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1, with higher score indicating better health state.~LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with Week 16 EQ-5D-5L Health State Index US and UK data.|||units on a scale||Standard Error|Least Squares Mean
2531658|NCT03334396|Secondary|Change From Baseline on the Work Productivity and Activity Impairment - Atopic Dermatitis (WPAI-AD) Questionnaire|"The WPAI-AD participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. The WPAI-AD consists of 6 items grouped in 4 domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment, that range from 0% to 100%, with higher values indicating greater impairment.~LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with Week 16 WPAI-AD data.|||units on a scale||Standard Error|Least Squares Mean
2531659|NCT03334396|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI)|"The DLQI is a simple, participant-administered,10 question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The recall period of this scale is over the last week. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and at unanswered (not relevant) responses scored as 0. Scores range from 0 to 30 (less to more impairment), and a 4-point change from baseline is considered as the minimal clinically important difference threshold.~LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with Week 16 DLQI data.|||units on a scale||Standard Error|Least Squares Mean
2531660|NCT03334396|Secondary|Change From Baseline on the Hospital Anxiety and Depression Scale (HADS)|The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 item questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects.|Baseline, 16 Weeks|All randomized participants with Week 16 HADS data.|||units on a scale||Standard Error|Least Squares Mean
2531661|NCT03334396|Secondary|Change From Baseline in the Patient Global Impression of Severity—Atopic Dermatitis (PGI-S-AD) Score|"The PGI-S-AD asked the participant to evaluate the severity of the disease at that point in time on a single-item, 5-point scale, using a daily diary. The same category labels used in the Physician's Global Assessment were used for the PGI-S-AD, i.e., (0) no symptoms, (1) very mild, (2) mild (3) moderate, and (4) severe.~LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with Week 16 PGI-S-AD data.|||units on a scale||Standard Error|Least Squares Mean
2531662|NCT03334396|Secondary|Change From Baseline in the Total Score of the Patient Oriented Eczema Measure (POEM)|"The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life.~LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with Week 16 POEM data.|||units on a scale||Standard Error|Least Squares Mean
2531683|NCT03334214|Secondary|Percentage of Participants With ≥ 30% Relative Reduction in Liver Fat Percentage|Percentage of participants with ≥ 30% relative reduction in liver fat percentage from baseline to post-treatment.|Week 15|The per protocol set included all randomized participants who received at least 10 of the prescribed doses and received the first 4 doses in the first 5 weeks, not missing 3 consecutive weekly doses and having no significant protocol deviations.|||percentage of participants|||Number
2531663|NCT03334396|Secondary|Percent Change From Baseline in Itch NRS|"The Itch NRS is a participant-administered, 11-point horizontal scale, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participant's itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours.~LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with Week 16 Itch NRS data.|||Percent Change||Standard Error|Least Squares Mean
2531664|NCT03334396|Secondary|Percentage of Participants Developing Skin Infections Requiring Antibiotic Treatment|Percentage of participants developing skin infections requiring antibiotic treatment.|16 Weeks|All randomized participants.|||percentage of participants|||Number
2531665|NCT03334396|Secondary|Change From Baseline in Body Surface Area (BSA) Affected|"Body surface area affected by AD will be assessed for 4 separate body regions and is collected as part of the EASI assessment: head and neck, trunk (including genital region), upper extremities, and lower extremities (including the buttocks). Each body region will be assessed for disease extent ranging from 0% to 100% involvement. The overall total percentage will be reported based off of all 4 body regions combined, after applying specific multipliers to the different body regions to account for the percent of the total BSA represented by each of the 4 regions. Use the percentage of skin affected for each region (0 to 100%) in EASI as follows: BSA Total = 0.1*BSAhead and neck + 0.3*BSAtrunk + 0.2* BSAupper limbs + 0.4*BSAlower limbs.~LS Means were calculated using MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with Week 16 BSA data.|||units on a scale||Standard Error|Least Squares Mean
2531666|NCT03334396|Secondary|Percentage of Participants Achieving SCORAD90|The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. SCORAD90 is defined as a ≥ 90% improvement from baseline in the SCORAD score.|16 Weeks|All randomized participants.|||percentage of participants|||Number
2531667|NCT03334396|Secondary|Change From Baseline in SCORAD|"The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with VAS where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease.~LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with Week 16 SCORAD data.|||units on a scale||Standard Error|Least Squares Mean
2531668|NCT03334396|Secondary|Percentage of Participants Achieving IGA of 0|The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.|16 Weeks|All randomized participants.|||percentage of participants|||Number
2531669|NCT03334396|Secondary|Percentage of Participants Achieving EASI50|The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2 and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI50 is defined as a ≥ 50% improvement from baseline in EASI score.|16 Weeks|All randomized participants.|||percentage of participants|||Number
2531670|NCT03334396|Secondary|Change From Baseline in the Skin Pain Numeric Rating Scale (NRS)|"Skin Pain NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing no pain and 10 representing worst pain imaginable. Overall severity of a participant's skin pain is indicated by selecting the number, using a daily diary, that best describes the worst level of skin pain in the past 24 hours.~LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with Week 16 Skin Pain NRS data.|||units on a scale||Standard Error|Least Squares Mean
2531671|NCT03334396|Secondary|Change From Baseline in the Score of Item 2 of the Atopic Dermatitis Sleep Scale (ADSS)|"Atopic Dermatitis Sleep Scale (ADSS) is a 3-item, participant-administered questionnaire developed to assess the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep last night. Item 2, frequency of waking last night is reported by selecting the number of times they woke up each night, ranging from 0 to 29 times,where the higher a number indicates a worse outcome. The ADSS is designed to be completed daily, using a daily diary, with respondents thinking about sleep last night. Each item is scored individually.~LS Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by- visit-interaction as fixed continuous effects."|Baseline, 16 Weeks|All randomized participants with Week 16 ADSS Item 2 (frequency of waking) data.|||units on a scale||Standard Error|Least Squares Mean
2531672|NCT03334396|Secondary|Percentage of Participants Achieving a 4-Point Improvement in Itch Numeric Rating Scale (NRS)|"The Itch Numeric Rating Scale (NRS) is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours."|16 Weeks|All randomized participants with a Baseline Itch NRS score >=4.|||percentage of participants|||Number
2531673|NCT03334396|Secondary|Percentage of Participants Achieving SCORing Atopic Dermatitis 75 (SCORAD75)|The SCORAD index uses the rule of nines to assess disease extent and evaluates 6 clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe). The SCORAD index also assesses subjective symptoms of pruritus and sleep loss with visual analog scale (VAS) where 0 is no itching or no trouble sleeping and 10 is unbearable itching or a lot of trouble sleeping. These 3 aspects: extent of disease (A: 0-1-2), disease severity (B: 0-18), & subjective symptoms (C: 0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103, where 0 = no disease and 103 = severe disease. The SCORAD75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the SCORAD score.|16 Weeks|All randomized participants.|||percentage of participants|||Number
2531674|NCT03334396|Secondary|Percent Change From Baseline in EASI Score|"The EASI assesses objective physician estimates of 2 dimensions of AD - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe).~Least Square (LS) Means were calculated using a MMRM model with treatment, region, baseline disease severity (IGA), visit, and treatment-by-visit-interaction as fixed categorical effects and baseline and baseline-by-visit-interaction as fixed continuous effect"|Baseline, 16 Weeks|All randomized participants who had Week 16 EASI data.|||percent change||Standard Error|Least Squares Mean
2531675|NCT03334396|Secondary|Percentage of Participants Achieving EASI90|The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI90 is defined as a ≥ 90% improvement from baseline in the EASI score.|16 Weeks|All randomized participants.|||percentage of participants|||Number
2531676|NCT03334396|Secondary|Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI75)|The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score.|16 Weeks|All randomized participants.|||percentage of participants|||Number
2531677|NCT03334396|Secondary|Percentage of Participants Achieving IGA of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 1 mg Baricitinib)|The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.|16 Weeks|All participants randomized to placebo or 1 mg of study drug.|||percentage of participants|||Number
2531678|NCT03334396|Primary|Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 With a ≥ 2 Point Improvement (Placebo, 2 mg, or 4 mg Baricitinib)|The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.|16 Weeks|All participants randomized to placebo, 2 mg, or 4 mg of study drug.|||percentage of participants|||Number
2531679|NCT03334214|Secondary|Absolute Change in Hemoglobin A1C (HbA1C)|Absolute change in HbA1C from baseline to post-treatment.|Week 14|The per protocol set included all randomized participants who received at least 10 of the prescribed doses and received the first 4 doses in the first 5 weeks, not missing 3 consecutive weekly doses and having no significant protocol deviations.|||percentage of total hemoglobin||Standard Deviation|Mean
2531680|NCT03334214|Secondary|Percent Change in Parameters of Insulin Resistance (IR)|Percent change in parameters of IR (fasting plasma glucose [FPG], homeostatic model assessment - insulin resistance [HOMA-IR], and insulin) from baseline to post-treatment.|Week 14|The per protocol set included all randomized participants who received at least 10 of the prescribed doses and received the first 4 doses in the first 5 weeks, not missing 3 consecutive weekly doses and having no significant protocol deviations. Number analyzed were the participants with analysis values at specified time point.|||percent change||Standard Deviation|Mean
2531681|NCT03334214|Secondary|Percent Change in Plasma Lipoprotein Profile|Percent change in plasma lipoprotein profile (total cholesterol, apolipoprotein B [ApoB], high density lipoprotein (HDL), low density lipoprotein cholesterol [LDL-C], non-HDL, triglycerides, and very low density lipoproteins [VLDL]) from baseline to the average of the post-treatment values assessed 1 and 2 weeks after the last dose (Post-Treatment 1 and Post-Treatment 2 visits).|Week 15|The per protocol set included all randomized participants who received at least 10 of the prescribed doses and received the first 4 doses in the first 5 weeks, not missing 3 consecutive weekly doses and having no significant protocol deviations.|||percent change||Standard Deviation|Mean
2552319|NCT02796092|Secondary|Procedure Radiation Dose (AK)|AK, total air kerma of the intervention (in mGy), recorded by fluoroscopy equipment|Intraoperative||||mGy||Standard Deviation|Mean
2531684|NCT03334214|Secondary|Percent Change in Liver Fat Percentage|Relative percent change in liver fat percentage from baseline to post-treatment MRI.|Baseline to Week 15|The per protocol set included all randomized participants who received at least 10 of the prescribed doses and received the first 4 doses in the first 5 weeks, not missing 3 consecutive weekly doses and having no significant protocol deviations.|||percent change||Standard Deviation|Mean
2531685|NCT03334214|Primary|Percentage of Participants With Adverse Events, Graded by Severity, That Were Related to Treatment With IONIS DGAT2Rx|AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, June 2010. Grades: mild - the event is easily tolerated by the participant and does not affect the participant's usual daily activities; moderate - the event causes the participant more discomfort and interrupts the participant's usual daily activities; severe - the event is incapacitating and causes considerable interference with the participant's usual daily activities.|Up to 176 days|The safety set included all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
2531686|NCT03334214|Primary|Percentage of Participants With Adverse Events That Were Related to Treatment With IONIS DGAT2Rx|An adverse event (AE) is any unfavorable and unintended sign (including a clinically-significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product.|Up to 176 days|The safety set included all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
2531687|NCT03334214|Primary|Absolute Change in Liver Fat Percentage (Per Protocol Population)|Absolute change in liver fat percentage as quantified by MRI-PDFF from baseline to post-treatment MRI.|Baseline to Week 15|The per protocol set included all randomized participants who received at least 10 of the prescribed doses and received the first 4 doses in the first 5 weeks, not missing 3 consecutive weekly doses and having no significant protocol deviations.|||liver fat percentage||Standard Deviation|Mean
2531688|NCT03334214|Primary|Absolute Change in Liver Fat Percentage (Randomized Population)|Absolute change in liver fat percentage as quantified by magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF) from baseline to post-treatment MRI.|Baseline to Week 15|The randomized population included all participants who are randomized into the study regardless of whether they received the study drug.|||liver fat percentage||Standard Deviation|Mean
2531689|NCT03333876|Secondary|Total Number of Audio Recordings|Total number of Audio recordings of snoring in different individuals in a baseline setting and using various anti-snoring solutions.|Baseline and 5 weeks|"All participants that entered the study had recordings. This record just includes snorer records, not bed partner.~12 recording could not be counted as they were not classified correctly by participants. Additional baseline nights were recorded by participants because of baseline extension or recordings in between device use."|||audio recordings|||Number
2531690|NCT03333876|Secondary|Overall Satisfaction of the Bed Partner of Each Solution|Overall Satisfaction of the Solution from the bed partner (0 to 10 scale). 0 is the worst, 10 is the best.|5 weeks|All bed partners that completed the final survey were included in the analysis. Not all bed partners completed the final survey.|||units on a scale||Standard Deviation|Mean
2531691|NCT03333876|Secondary|Understand User Acceptance of the Bed Partner of Each Solution|likeliness to recommend purchase (0 to 10 scale). 0 is the worst, 10 is the best.|5 weeks|All bed partners that completed the final survey were included in the analysis.|||units on a scale||Standard Deviation|Mean
2531692|NCT03333876|Secondary|Users Acceptance of Each Solution|A star rating based on a 1 -5 scale, overall customer satisfaction with the product (0 to 10 scale), likeliness to buy the product (0 to 10 scale), likeliness to recommend purchase (0 to 10 scale). For the Star rating 1 is the worst, 5 is the best. For the 0 to 10 scale, 0 is the worst, 10 is the best. This was the average acceptance of all users.|5 weeks|All snorers were included in the analysis|||units on a scale||Standard Deviation|Mean
2531693|NCT03333876|Primary|Bed Partners' Rating of Sleep Disturbance Due to Partner Snoring|"Bed partner subjective feedback based upon a 0 to 10 scale of how much did your partner's snoring disturb your sleep last night. 0 was the worst, 10 was the best. This is was evaluated at the end of each period."|5 weeks|This includes all bed partners that completed the subjective feedback survey.|||units on a scale||Standard Deviation|Mean
2531694|NCT03333746|Other Pre-specified|Pharmacodynamics Profiles:Time to Maximum Plasma Concentration (Tmax)|Will be assessed using Tmax for Nivolumab in combination with lenalidomide|Screening, days 1 and 14 of each cycle|data not collected and analyzed||||||
2531695|NCT03333746|Other Pre-specified|Pharmacokinetics: The Maximum Plasma Concentration (Cmax)|Will be assessed using Cmax for Nivolumab in combination with lenalidomide|Screening, days 1 and 14 of each cycle|data not collected and analyzed||||||
2531696|NCT03333746|Other Pre-specified|Immunomonitoring of Lymphocytes Subsets Including T Cell|Will be explored using graphical analyses as well as summarized quantitatively.|Up to 3 years|data not collected and analyzed||||||
2531697|NCT03333746|Other Pre-specified|Immunomonitoring of Lymphocytes Subsets Including Natural Killer (NK) Cell|Will be explored using graphical analyses as well as summarized quantitatively.|Up to 3 years|data not collected and analyzed||||||
2531698|NCT03333746|Secondary|Time to Progression (TTP)|Will be assessed.|Time from start of treatment until the date he or she has progression or dies, assessed up to 3 years|data was not collected and analyzed||||||
2531699|NCT03333746|Secondary|Progression Free Survival (PFS)|Will evaluate other clinical outcomes using the methods of Kaplan-Meier.|Time from study entry until disease progression or death at trial closure for the per protocol population, assessed up to 3 years|data was not collected and analyzed||||||
2531700|NCT03333746|Secondary|Overall Survival (OS)|Will evaluate other clinical outcomes using the methods of Kaplan-Meier.|Up to 3 years|data was not collected and analyzed||||||
2531701|NCT03333746|Primary|ORR (Overall Response Rate)|Will be assessed by IMWG response criteria. 95% binomial confidence intervals will also be calculated for the estimate of the proportion of responses.|Up to 12 months|data was not collected and analyzed||||||
2531702|NCT03333577|Primary|Percentage Correct on Word Identification Task|one list of monosyllabic words (PBK words) was assessed at 60dBA, with word scores recorded as a percent correct.|4 weeks post fitting||||% corrrect words||Standard Deviation|Mean
2553550|NCT02774343|Secondary|Feasibility - Subject Retention as Assessed by Number of Participants Who Completed All 12 Weeks of the Study||week 12||||Participants|||Count of Participants
2531704|NCT03333317|Secondary|Acceptability and Palatability of Lumicitabine Formulation as Assessed by Clinician Electronic Clinical Outcome Assessment (eCOA)|Acceptability and Palatability of lumicitabine formulation was assessed by clinician eCOA questionnaire ranging from score 0 (minimum; best) to 8 (maximum; worse).|Up to Day 6|As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.||||||
2531705|NCT03333317|Secondary|Number of Participants With Emergent Postbaseline Changes in the RSV Polymerase L-gene and Other Regions of the RSV Genome Compared With Baseline Sequences|Number of participants with emergent postbaseline changes in the RSV polymerase L-gene and other regions of the RSV genome compared with baseline sequences were reported.|Baseline up to 28 days|Randomized or Treated set was defined as all participants who were in Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or all participants treated (AST) set.|||Participants|||Count of Participants
2531706|NCT03333317|Secondary|AUC of RSV Viral Load From Baseline Until 1 Day After the Last Dose of Study Drug|AUC of RSV viral load was measured in midturbinate nasal swabs and in endotracheal samples.|Baseline Until 1 Day after the last dose of study drug (up to 10 days)|As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.||||||
2531707|NCT03333317|Secondary|AUC of RSV RNA Viral Load From Baseline up to Day 14|AUC of RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples.|Baseline up to Day 14|As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.||||||
2531708|NCT03333317|Secondary|AUC of RSV RNA Viral Load From Baseline up to Day 10|AUC of RSV RNA viral load was measured in mid-turbinate nasal swabs and in the endotracheal sample.|Baseline up to Day 10|As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.||||||
2531709|NCT03333317|Secondary|Percentage of Participants With Undetectable RSV Viral Load|Percentage of participants with the undetectable viral load was reported.|Up to 28 days|As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.||||||
2531710|NCT03333317|Secondary|Time to RSV Ribonucleic Acid (RNA) Being Undetectable|Time to RSV RNA being undetectable (the time from initiation of study treatment until the time at which it is observed that the virus is undetectable in an assessment and after which time no virus positive assessment follows) was assessed as measured by qRT-PCR.|Up to 28 days|As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.||||||
2531711|NCT03333317|Secondary|Percentage of Participants With Decline of Viral Load|Percentage of participants with decline in viral load during treatment as measured by qRT-PCR was reported.|Up to 28 days|ITT-i set was defined as all randomly assigned participants who receive at least 1 dose of study drug and who have an RSV infection confirmed by a PCR-based assay at baseline or within 1 hour after the first study medication intake at the central laboratory.|||Percentage of participants|||Number
2531712|NCT03333317|Secondary|Time To Peak Viral Load|Time to peak viral load was reported.|Up to 28 days|As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.||||||
2531713|NCT03333317|Secondary|Peak Viral Load|Peak viral load was measured by qRT-PCR in the mid-turbinate nasal swab specimens.|Up to 28 days|As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.||||||
2531714|NCT03333317|Secondary|RSV Viral Load Over Time|RSV viral load over time was measured by qRT-PCR in the mid-turbinate nasal swab specimens.|On Day 2, 3, 4, 5, 6, 7, 10, 14 and 28|Intention-To-Treat-infected (ITT-i) set was defined as all randomly assigned participants who receive at least 1 dose of study drug and who have an RSV infection confirmed by a polymerase chain reaction (PCR)-based assay at baseline or within 1 hour after the first study medication intake at the central laboratory.|||log10 per milliliters (log10/mL)||Standard Deviation|Mean
2531715|NCT03333317|Secondary|Severity of Signs and Symptoms of RSV Infection Assessed by the Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS)|The severity of signs and symptoms of RSV infection were assessed by the PRESORS. PRESORS Score consisted of 5-items, each score ranges from 0 to 3 and the total score was analyzed by summing up the individual score ranging from 0 (minimum; best) to 15 (maximum; worse).|Up to 28 days|As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.||||||
2531716|NCT03333317|Secondary|Duration of Signs and Symptoms of RSV Infection|Duration of signs and symptoms of RSV infection was assessed.|Up to 28 days|As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.||||||
2531717|NCT03333317|Secondary|Number of Participants With Acute Otitis Media|Number of participants with acute otitis media was reported.|Up to 28 days|Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.|||Participants|||Count of Participants
2531718|NCT03333317|Secondary|Time for Body Temperature to Return To Pre-RSV Infection Status|Time for body temperature to return to pre-RSV infection status was measured.|Up to 28 days|Population included randomized or treated set. As study was terminated early with fewer participants than planned, data was not summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm.|||Hours|||Number
2531719|NCT03333317|Secondary|Time for SpO2 to Return to Pre-RSV Infection Status|Time for SpO2 to return to pre-RSV infection status was measured.|Up to 28 days|Population included randomized or treated set. As study was terminated early with fewer participants than planned, data was not summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm.|||Hours|||Number
2531861|NCT03328208|Secondary|Number of Participants Returning Diary Card Packages|Follow-up feasibility defined as obtaining 38 packages of filled out diary cards (at least 16 from patients in the app group and at least 16 from patients in the control group)|Up to 6 months||||Participants|||Count of Participants
2531720|NCT03333317|Secondary|Time for Respiratory Rate to Return to Pre-RSV Infection Status|Time for the respiratory rate to return to pre-RSV infection status was measured.|Up to 28 days|Population included randomized or treated set. As study was terminated early with fewer participants than planned, results for this endpoint could not be summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm.|||Hours|||Number
2531721|NCT03333317|Secondary|Time From Initiation of Study Treatment Until Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to (>=)93 Percent (%) on Room Air Among Participants Who Were Not on Supplemental Oxygen Prior to Onset of Respiratory Symptoms|Time from initiation of study treatment until SpO2 >=93% on room air among participants who were not on supplemental oxygen prior to the onset of respiratory symptoms was reported.|Up to 28 days|As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.||||||
2531722|NCT03333317|Secondary|Time to Clinical Stability|Time to clinical stability was defined as the time at which the following criteria are all met: normalization of blood oxygen level (return to baseline, by pulse oximetry) without the requirement of supplemental oxygen beyond baseline level, normalization of oral feeding, normalization of respiratory rate, and normalization of heart rate.|Up to 28 days|Population included randomized or treated set. Due to early study termination and less number of participants collected data was not summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm.|||Hours|||Number
2531723|NCT03333317|Secondary|Time to no Longer Requiring Supplemental Oxygen|Time to no longer requiring supplemental oxygen above pre-RSV infection status was reported.|Up to 28 days|Population included randomized or treated set who received supplemental oxygen.|||Hours|||Number
2531724|NCT03333317|Secondary|Duration of Invasive Mechanical Ventilation Support|Duration of invasive mechanical ventilation support (for example, endotracheal-mechanical ventilation or mechanical ventilation via tracheostomy) to deliver oxygen above pre-RSV infection status was measured.|Up to 28 days|No participant received invasive mechanical ventilation support hence results could not be drawn for this outcome measure.||||||
2531725|NCT03333317|Secondary|Duration of Non-invasive Mechanical Ventilation Support|Duration of non-invasive mechanical ventilation support (that is, continuous positive airway pressure) to deliver oxygen above pre-RSV infection status was measured.|Up to 28 days|No participant received non-invasive mechanical ventilation support hence results could not be drawn for this outcome measure.||||||
2531726|NCT03333317|Secondary|Duration of Supplemental Oxygen|Duration of supplemental oxygen above pre-RSV infection status was assessed.|Up to 28 days|Population included randomized or treated set who received supplemental oxygen.|||Hours|||Number
2531727|NCT03333317|Secondary|Number of Participants Who Required Invasive Mechanical Ventilation Support|The number of participants who required invasive mechanical ventilation support (for example, endotracheal-mechanical ventilation or mechanical ventilation via tracheostomy) above pre-RSV infection status was reported.|Up to 28 days|Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.|||Participants|||Count of Participants
2531728|NCT03333317|Secondary|Number of Participants Who Required Non-invasive Mechanical Ventilation Support|The number of participants who required non-invasive mechanical ventilation support (that is, continuous positive airway pressure) above pre-RSV infection status was reported.|Up to 28 days|Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.|||Participants|||Count of Participants
2531729|NCT03333317|Secondary|Number of Participants Who Required Supplemental Oxygen|The number of participants who required supplemental oxygen above pre-RSV infection status was reported.|Up to 28 days|Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.|||Participants|||Count of Participants
2531730|NCT03333317|Secondary|Duration of ICU Stay|In the event that a participant required ICU, the duration for how long the participant remained in the ICU was reported.|Up to 28 days|No participant was admitted to ICU hence results could not be determined for this outcome measure.||||||
2531731|NCT03333317|Secondary|Number of Participants Admitted to the Intensive Care Unit (ICU)|Number of participants who were admitted to the ICU was reported.|Up to 28 days|Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set.|||Participants|||Count of Participants
2531732|NCT03333317|Secondary|Length of Hospital Stay|Length of hospital stay is defined as the time from hospitalization to actual hospital discharge.|Up to 28 days|Population included randomized or treated set. As the study was early terminated with fewer participants than planned, results for this endpoint could not be summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm.|||Hours|||Number
2531733|NCT03333317|Secondary|Predicted Concentration of JNJ-63549109 (Metabolite of Lumicitabine) at 12 Hours Postdose (C12h)|C12h is the predicted concentration of JNJ-63549109 at 12 hours Postdose. C12h is a model-based prediction. It was determined using a population pharmacokinetic (PK) model and based on the individual model predicted concentration-time profiles.|12 hours postdose|As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.||||||
2531734|NCT03333317|Secondary|Trough Observed Analyte Concentration (C[Trough]) of JNJ-63549109 (Metabolite of Lumicitabine)|C(trough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen of JNJ-63549109 (Metabolite of Lumicitabine).|Day 1 and Day 5|ITT set was defined as all randomized participants who receive at least 1 dose of study.|||ng/ml||Standard Deviation|Mean
2531735|NCT03333317|Secondary|Area Under Plasma Concentration-time Curve (AUC) of JNJ-63549109 (Metabolite of Lumicitabine)|AUC is the area under the plasma concentration-time curve of JNJ-63549109 (Metabolite of Lumicitabine).|Day 1 and Day 5|ITT set was defined as all randomized participants who receive at least 1 dose of study.|||nanogram hour per milliliters (ng*h/ml)||Standard Deviation|Mean
2531736|NCT03333317|Secondary|Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 (Metabolite of Lumicitabine)|Cmax is the maximum observed plasma concentration of JNJ-63549109 (Metabolite of Lumicitabine).|Day 1 and Day 5|Intent to Treat (ITT) set was defined as all randomized participants who receive at least 1 dose of study.|||nanogram/milliliter (ng/ml)||Standard Deviation|Mean
2531737|NCT03333317|Secondary|Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades)|Number of participants with Laboratory (hematology, serum chemistry, and urinalysis) abnormalities reported based on DMID toxicity grading scale. DMID toxicity grades ranges from 1 to 4. Grade 0 is normal and not meeting the criteria of Grade 1-4. Hb: Grade 1: for 22-35 days old- 9.5-10.5 gram per deciliter (g/dL); for 36-60 days old- 8.5-9.4 g/dL; for 61-90 days old- 9.0-9.9 g/dL; Hb: Grade 2: for 22-35 days old- 8.0-9.4 g/dL, for 36-60 days old- 7.0-8.4 g/dL; for 61-90 days old- 7.0-8.9 g/dL. ALT: Grade 1- 1.1 - <2.0*Upper limit of normal (ULN); Creatinine: Grade 2- 1.8-2.4 milligram per deciliter (mg/dL); Hyperkalemia: Grade 1- 3.0-3-5 milliequivalents per Liter (mEq/L); ANC: Grade 1: for 7-60 days old- 1200-1800/ millimeter cube(mm^3); for 61-90 days old- 750-1200/mm^3; ANC: Grade 3: for 7-60 days old- 500-899/mm^3, for 61-90 days old- 250-399/mm^3; ANC: Grade 4- for 7-60 days old <500/mm^3, for 61-90 days old- <250/mm^3; Platelets: Grade 3: 25000 - 49999/mm^3.|Up to 28 days|Safety analysis set was defined as all participants who received at least 1 dose of study drug, analyzed as treated.|||Participants|||Count of Participants
2531738|NCT03333317|Secondary|Number of Participants With Electrocardiogram (ECG) Abnormalities|The number of participants with ECG (QT, and QTc intervals) abnormalities reported.|Up to 28 days|Safety analysis set was defined as all participants who received at least 1 dose of study drug, analyzed as treated.|||Participants|||Count of Participants
2531739|NCT03333317|Secondary|Number of Participants With Emergent Clinical Relevant Vital Signs Abnormalities|The number of participants with emergent clinically relevant vital signs (temperature, pulse rate, respiratory rate, diastolic blood pressure, systolic blood pressure, oxygen saturation) abnormalities that emerged after treatment initiation reported. An abnormality was considered emergent in a particular phase if it is worse than baseline. If baseline is missing, the abnormality is always considered as emergent. A shift from 'abnormally low' at baseline to 'abnormally high' post baseline (or vice versa) was also emergent.|Up to 28 days|Safety analysis set was defined as all participants who received at least 1 dose of study drug, analyzed as treated.|||Participants|||Count of Participants
2531740|NCT03333317|Secondary|Number of Participants With Clinically Significant Physical Examinations Abnormalities|The number of participants with clinically significant physical examination (respiratory system, nose, ear, throat, facial and neck lymph nodes, and skin examination) abnormalities that emerged after treatment initiation was reported.|Up to 28 days|Randomized or Treated set was defined as all participants who were in Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or all participants treated (AST) set.|||Participants|||Count of Participants
2531741|NCT03333317|Secondary|Number of Participants With Emergent Adverse Event|An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. All AEs reported during treatment or follow-up were considered emergent and were included in the analysis.|Up to 28 days|Safety analysis set was defined as all participants who received at least 1 dose of study drug, analyzed as treated.|||Participants|||Count of Participants
2531742|NCT03333317|Primary|Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load|AUC of RSV viral load was measured by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of the mid-turbinate nasal swab.|Day 1 to 7: Predose, 0.25 and 2 hours postdose|As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed.||||||
2531743|NCT03331835|Other Pre-specified|Change From Baseline at Week 24 in NAPSI Total Score|"The Nail Psoriasis Severity Index (NAPSI) grades nails by first dividing the nail area with imaginary horizontal and vertical lines into 4 quarters. The following 8 clinical features of nail psoriasis are then scored based on the number of quarters in which the feature is present (0 to 4) to arrive at a NAPSI score of 0 to 32 for each nail:~Pitting.~Leukonychia.~Red spots in lunula.~Nail plate crumbling.~Oil drop (salmon patch) discoloration.~Onycholysis.~Nail bed hyperkeratosis.~Splinter haemorrhages.~A negative change in NAPSI score means that the NAPSI score was lower at the time of data collection."|Baseline to Week 24|Only participants with nail involvement at baseline were included in the analysis. Therefore the number of analysed participants differs from the number of randomised participants.|||score on a scale||Standard Error|Mean
2531744|NCT03331835|Secondary|DLQI Total Score of 0 or 1 at Week 24|DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their QoL over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4 point Likert scale (0 = not at all ⁄not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor QoL.|Week 24||||Participants|||Count of Participants
2531754|NCT03331835|Secondary|Having Least 90% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 90 Response) From Baseline at Week 24|"The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region.~Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease)."|Baseline to Week 24||||Participants|||Count of Participants
2531745|NCT03331835|Secondary|Change From Baseline at Week 24 in Dermatology Life Quality Index (DLQI) Total Score|DLQI consists of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the treatment. Each item is scored on a 4 point Likert scale (0 = not at all ⁄not relevant; 1 = a little; 2 = a lot; 3 = very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor QoL.|Baseline to Week 24|The number of analysed participants is not the same as the number of randomised participants, as participants with missing data in all visits for a given endpoint are not included in the mixed model for repeated measurements (MMRM) analysis used to analyse the endpoint.|||score on a scale||Standard Error|Mean
2531746|NCT03331835|Secondary|Burden of Symptoms|"Burden of symptoms was assessed as the normalised area under the curve (AUC) of PSI from baseline to the last available assessment. The AUC for the PSI total score was calculated for each participant using the standard trapezoidal rule. The AUC was normalised by dividing it with the time from baseline to the last available assessment of the PSI total score.~The PSI consists of eight psoriasis-specific questions. Trial participants rated the severity of their symptoms in the last 24 hours from 'not at all' to 'very severe,' ranging from 0 to 4. Total scores range from 0 to 32 with higher scores indicating worse symptoms."|Baseline to Week 24|Not all participants had recorded PSI data, therefore the analysed number of participants is lower than the randomised number of participants.|||score on a scale||Standard Error|Mean
2531747|NCT03331835|Secondary|Number of Symptom-free Days From Randomisation to Week 24|The PSI consists of eight psoriasis-specific questions. Trial participants rated the severity of their symptoms in the last 24 hours from 'not at all' to 'very severe,' ranging from 0 to 4. Total scores range from 0 to 32 with higher scores indicating worse symptoms. PSI response is defined as total score ≤8 and no item score >1. Symptom-free day is defined as having daily total PSI of 0 on that day.|Baseline to Week 24|PSI data was missing for many participants at baseline and Week 24. For this reason, no statistical analysis was performed.|||days||Standard Deviation|Mean
2531748|NCT03331835|Secondary|PSI Total Score of 0 at Week 24|The PSI consists of eight psoriasis-specific questions. Trial participants rated the severity of their symptoms in the last 24 hours from 'not at all' to 'very severe,' ranging from 0 to 4. Total scores range from 0 to 32 with higher scores indicating worse symptoms. PSI response is defined as total score ≤8 and no item score >1. Symptom-free day is defined as having daily total PSI of 0 on that day.|Week 24|PSI data was missing for many participants at baseline and Week 24. For this reason, no statistical analysis was performed. The data shown is therefore descriptive data.|||Participants|||Count of Participants
2531749|NCT03331835|Secondary|Psoriasis Symptom Inventory (PSI) Responder at Week 24 (Total Score ≤ 8, With no Item Scores > 1)|The PSI consists of eight psoriasis-specific questions. Trial participants rated the severity of their symptoms in the last 24 hours from 'not at all' to 'very severe,' ranging from 0 to 4. Total scores range from 0 to 32 with higher scores indicating worse symptoms. PSI response is defined as total score ≤8 and no item score >1. Symptom-free day is defined as having daily total PSI of 0 on that day.|Week 24|PSI data was missing for many participants at baseline and Week 24. For this reason, no statistical analysis was performed. The data shown is therefore descriptive data.|||Participants|||Count of Participants
2531750|NCT03331835|Secondary|Change From Baseline at Week 24 in Affected Body Surface Area (BSA)|"The surface area of the participant's hand (palm and fingers) is used as a reference measurement to calculate the percentage of each body region that is affected by psoriasis. One hand is approximately equal to 1% total BSA.~Furthermore, the complete body surface area (BSA=100%) can be divided into regions that approximates percentages of BSA as follows: head and neck (10%), upper extremities (20%), the trunk including the axillae and groin (30%), and finally the lower extremities, including the buttocks (40%).~A negative value in the percent change from baseline that the affected BSA was lower at the time of data collection."|Baseline to Week 24||||percent change||Standard Error|Mean
2531751|NCT03331835|Secondary|Percent Change From Baseline in PASI Score at Week 24|"The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region. Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).~A negative value in the percent change from baseline that the PASI score was lower at the time of data collection."|Baseline to Week 24|The number of analysed participants is not the same as the number of randomised participants, as participants with missing data in all visits for a given endpoint are not included in the mixed model for repeated measurements (MMRM) analysis used to analyse the endpoint.|||percent change in PASI||Standard Error|Mean
2531752|NCT03331835|Secondary|Change From Baseline at Week 24 in PASI Score|"The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region. Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease).~A negative change in PASI score means that the PASI score was lower at the time of data collection."|Baseline to Week 24|The number of analysed participants is not the same as the number of randomised participants, as participants with missing data in all visits for a given endpoint are not included in the mixed model for repeated measurements (MMRM) analysis used to analyse the endpoint.|||score on a scale||Standard Error|Mean
2531753|NCT03331835|Secondary|Having 100% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 100 Response) From Baseline at Week 24|"The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region.~Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease)."|Baseline to Week 24||||Participants|||Count of Participants
2531787|NCT03330041|Secondary|Width of Scar|"A secondary endpoint will include the width of the scar 1 cm from midline on each side.~This measurement will be reported in mm"|3 months following procedure||||mm||Standard Deviation|Mean
2531755|NCT03331835|Primary|Static Physician's Global Assessment (sPGA) Scale Score of 0 or 1 at Week 24|"sPGA is a 6-point scale that represents the average lesion severity on the trunk and limbs. The assessment is based on the condition of the disease at the time of evaluation.~Static Physician's Global Assessment is a scale ranging rom 0 (clear skin) to 5 (severe disease)."|Baseline to Week 24||||Participants|||Count of Participants
2531756|NCT03331835|Primary|Having Least 75% Lower Psoriasis Area and Severity Index (PASI) Score Relative to Baseline (PASI 75 Response) From Baseline at Week 24|"The PASI score grades the extent and severity of psoriatic involvement for each of four body regions (head and neck, upper extremities, trunk, and lower extremities) using a 7-point scale for extent of involvement in each body region and 5-point scales for severity of each of the clinical signs redness, thickness, and scalliness in each body region.~Psoriasis Area and Severity Index is a scale ranging from 0 (no disease) to 72 (maximal disease)."|Baseline to Week 24||||Participants|||Count of Participants
2531757|NCT03331315|Secondary|Number of Oral Narcotic Pills Used After Discharge|Number of oral narcotic pills used after discharge until 2 week postoperative visit.|2 weeks after discharge||||Pills||Standard Deviation|Mean
2531758|NCT03331315|Secondary|Days of Oral Narcotic Use After Discharge|Measured using postoperative questionnaire|2 weeks after discharge||||Days||Standard Deviation|Mean
2531759|NCT03331315|Secondary|Return to Activities of Daily Living|Average number of days required for complete return to independent activities of daily living|2 weeks after discharge||||Days||Standard Deviation|Mean
2531760|NCT03331315|Secondary|Number of Participants With Perioperative Complications|Perioperative Complications measured intraoperatively and postoperatively by type|During and after surgery||||Patients|||Number
2531761|NCT03331315|Secondary|Total Hospital Stay|Total hospital stay from time fo admission to time of discharge measured in hours|Following surgery||||Hours||Standard Error|Mean
2531762|NCT03331315|Secondary|Average Inpatient Ondansetron Use|Average inpatient ondansetron use measured in milligrams|48 hrs following surgery||||Milligrams||Standard Deviation|Mean
2531763|NCT03331315|Secondary|Average Inpatient Hydromorphone Use|Average inpatient hydromorphone use measured in milligrams|48 hrs following surgery||||Milligrams||Standard Deviation|Mean
2531764|NCT03331315|Primary|Average Inpatient Postoperative Pain Score|Pain measured using the Visual Analog Scale, no pain (0-0.4 cm), mild pain(0.5-4.4 cm), moderate pain (4.5-7.4 cm), and severe pain (7.5-10.0 cm). Subscale scoring was not used in analysis but provided as reference for patient and nursing staff.|48 hrs following surgery||||units on a scale||Standard Deviation|Mean
2531765|NCT03331185|Secondary|Post-operative Pain and Swelling|Post-operative pain and complications measured by VAS-questionnaire obtained following extraction and grafting. The VAS-questionnaire contained the following categories to be answered 7days post-operatively: Pain, Swelling. A visual line scale of 100mm in length was provided with no pain/swelling on the one end and severe pain/swelling on the opposite end. Participants were instructed to rate their pain and swelling by marking a single line on the scale indicating the degree of pain/swelling they experienced. Markings were physically measured on the scale and converted into a score with 0 representing no pain/swelling and 1 representing severe pain/swelling.|Measured at 7 days following extraction and grafting||||score on a scale||Standard Deviation|Mean
2531766|NCT03331185|Secondary|Buccolingual Change in Width of Keratinized Soft Tissue|Difference in post operative measurement analysis of keratinized gingiva changes following extraction and alveolar ridge preservation|Soft tissue measurement at time of extraction and grafting and 12 weeks after extraction and grafting|Only nine patients had implants placed within the exact specified 12 week timeframe from the date of extraction, therefore data collection and analysis were only performed on these participants.|||Millimeters||Standard Error|Mean
2531767|NCT03331185|Primary|Overall Horizontal Change in Alveolar Ridge Width|Calculated mean of post operative CBCT measurements of horizontal alveolar bone width changes following extraction and alveolar ridge preservation.|Difference reported on horizontal changes comparing CBCT analysis 11weeks after extraction and grafting compared to CBCT following extraction and grafting||||Millimeters||Standard Error|Mean
2531768|NCT03331042|Other Pre-specified|Number of Minutes of Sleep in Stages N1, N2, N3, Rapid Eye Movement (REM) and Latency to REM Onset.|Effect of SM-1 and the two 2-drug combination products (diphenhydramine plus zolpidem and diphenhydramine plus lorazepam) on sleep stage distribution.|8 hours|||||||
2531769|NCT03331042|Secondary|Number of Participants According to Sleep Quality|Subject reported sleep quality, how well the subject felt he or she slept, from Post-Sleep Questionnaire (PSQ).|Up to 22 days.|All subjects who were randomized to a treatment sequence, and had taken any study drug.|||Participants|||Count of Participants
2531770|NCT03331042|Secondary|Subjective Number of Awakenings (sNAW)|Subject reported NAW from Post-Sleep Questionnaire (PSQ).|Up to 22 days.|All subjects who were randomized to a treatment sequence, and had taken any study drug.|||awakenings||Standard Deviation|Mean
2531771|NCT03331042|Secondary|Subjective Sleep Onset Latency (sSOL)|Subject reported SOL, the amount of time the subject felt it took to fall asleep, from Post-Sleep Questionnaire (PSQ).|Up to 22 days.|All subjects who were randomized to a treatment sequence, and had taken any study drug.|||minutes||Standard Error|Mean
2531772|NCT03331042|Secondary|Subjective Total Sleep Time (sTST)|Subject reported TST from Post-Sleep Questionnaire (PSQ).|Up to 22 days.|All subjects who were randomized to a treatment sequence, and had taken any study drug.|||minutes||Standard Deviation|Mean
2531773|NCT03331042|Secondary|Number Correct on Digit Symbol Substitution Test (DSST)|Morning alertness measured by DSST. The digit symbol substitution test assesses attention, psychomotor speed, complex scanning, visual tracking, and immediate memory. This test consists of 4 rows each with 25 small blank squares; above each square is a number between 1 and 9. At the top is a 'key,' which pairs each number (1 through 9) with an unfamiliar symbol. The participant has 90 seconds to work as quickly as possible (left to right across the rows) to fill in each blank square with the appropriate symbol based on the number above the square. Results are presented as total number correct; therefore, lower numbers indicate greater impairment. Scores on the DSST range from 0-93|Up to Visit 5|Safety Population included all subjects that received any study drug, and were grouped by actual treatment.|||number correct||Standard Deviation|Mean
2532373|NCT03307005|Primary|Total Sleep Time|Mean change in total sleep time on second sleep study minus total sleep time on first sleep study. Higher values suggest more total sleep time. Total sleep time is measured in minutes.|1 week||||minutes||Full Range|Mean
2531774|NCT03331042|Secondary|Karolinska Sleepiness Scale (KSS) of Morning Alertness.|Morning alertness measured by Karolinska Sleepiness Scale (KSS). KSS ranges from 1-9, with higher numbers indicating sleepier and lower numbers more alert.|Up to Visit 5|The Safety Population included all subjects that received any study drug, and were grouped by actual treatment.|||units on a scale||Standard Deviation|Mean
2531775|NCT03331042|Secondary|Wakefulness After Sleep Onset (WASO)|WASO efficacy of SM-1 versus placebo, combination product diphenhydramine plus zolpidem and combination product diphenhydramine plus lorazepam measured by polysomnography (PSG)-measured sleep maintenance as the amount of time spent awake after falling asleep.|8 hours|Full analysis set consisted of all subjects who were randomized to a treatment sequence, and had taken any study drug.|||minutes||Standard Deviation|Mean
2531776|NCT03331042|Secondary|Number of Awakenings (NAW)|NAW efficacy of SM-1 versus placebo, combination product diphenhydramine plus zolpidem and combination product diphenhydramine plus lorazepam measured by polysomnography (PSG)-measured sleep maintenance.|8 hours|Full analysis set consisted of all subjects who were randomized to a treatment sequence, and had taken any study drug.|||awakenings||Standard Deviation|Mean
2531777|NCT03331042|Secondary|Latency to Persistent Sleep (LPS)|Efficacy of SM-1 versus placebo, combination product diphenhydramine plus zolpidem and combination product diphenhydramine plus lorazepam measured by polysomnography (PSG)-measured sleep induction, the amount of time it takes the subject to fall asleep.|8 hours|Full analysis set consisted of all subjects who were randomized to a treatment sequence, and had taken any study drug.|||minutes||Standard Deviation|Mean
2531778|NCT03331042|Primary|Total Sleep Time (TST)|TST efficacy of SM-1 versus placebo, combination product diphenhydramine plus zolpidem and combination product diphenhydramine plus lorazepam measured by polysomnography (PSG)-defined total sleep time (TST)|8 hours|Full analysis set consisted of all subjects who were randomized to a treatment sequence, and had taken any study drug.|||minutes||Standard Deviation|Mean
2531779|NCT03330275|Secondary|Average Pedestrian Recognition Distance|"The in-vehicle measurement system was utilized to determine the distance at which the participant (as a driver) first recognizes the presence of two pedestrians positioned at the side of the road. An experimenter acted as the pedestrian and walked in-place at the end of a 400 m straight section of roadway which starts and finishes at approximately the same elevation, but features a dip halfway along its length. The pedestrian was not surrounded by any visual clutter or lighting. To reduce expectancy effects, a series of four flashing LEDs and four retro-reflective bollards was positioned around the circuit to increase the instances of flashing lights and retro-reflective material being presented to the driver. The average distance to recognize a pedestrian for each lens type was reported."|15 Minutes Post Lens Fitting|All subjects that completed the study without a major protocol deviation.|||Meters||Standard Deviation|Mean
2531780|NCT03330275|Secondary|Percentage of Hazards Avoided During Night Driving|"Participants were required to report and avoid hitting any of nine large, low contrast grey foam hazards (220 cm x 80 cm x 15 cm) positioned orthogonally in the driving lane along the roadway, the locations of which will be randomized between study lenses. The percentage of Hazards avoided for each study lens was reported."|15 Minutes Post Lens Fitting|All subjects that completed the study without a major protocol deviation.|||Percentage of Participants|||Number
2531781|NCT03330275|Secondary|Average Distance to Correctly Identify Road Signs During Night Driving|Measure Description The distance (measured in meters) to recognize a pre-determined road sign was recorded for each subject and lens type at either visit 3 or visit 4, using the in-vehicle measurement system while the participant was driving. The in-vehicle measurement system consisted of a subject pressing a button once the subject was able to recognize the road sign. The average distance in meters was reported for each lens type. Larger distance indicate that a subject was able to identify the pre-determined road sign sooner.|15 Minutes Post Lens Fitting|All subjects that completed the study without a major protocol deviation.|||Meters||Standard Deviation|Mean
2531782|NCT03330275|Secondary|Percentage of Road Signs Correctly Identified During Night Driving|Participants were instructed to report the identity of a percentage of the standard road signs (typically about 42 signs dependent on the route travelled) containing about 65 items of information as they drove around the circuit. The percentage of correctly identified signs was reported for each study lens.|15 Minutes Post Lens Fitting|All subjects that completed the study without a major protocol deviation.|||Percentage of participants|||Number
2531783|NCT03330275|Secondary|Binocular Contrast Threshold Without Glare|Binocular contrast sensitivity was assessed under low luminance conditions. Five Landolt C targets in random orientation were presented for each of the four contrast levels 95%, 80%, 63% and 50%. Participants were asked to correctly identify the orientation of the Landolt C. The percentage of subjects that were able to correct identify the orientation of all 5 Landolt's C was reported for each lens type.|15 Minutes Post Lens Fitting|All subjects that completed the study without a major protocol deviation.|||Percentage of Participants|||Number
2531784|NCT03330275|Secondary|Binocular Visual Acuity|Binocular visual acuity was assessed under Low luminance (~1 lux) high contrast (90%) conditions at a distance of 4 meters. The ETDRS logMAR chart were used, which is scored on a letter by letter basis (-0.02 log units per letter correctly identified). A number of different EDTRS charts was used to reduce potential learning effects. The average LogMAR acuity for each lens was reported.|15 Minutes Post Lens Fitting|All subjects that completed the study without a major protocol deviation.|||logMAR||Standard Deviation|Mean
2531785|NCT03330275|Primary|Overall Nighttime Driving Score|Overall driving performance score is a composite score calculated as the mean of the Z-scores of the following six driving measures: average sign recognition distance (in meters), percentage of correctly identified sign (~42 signs), percentage of hazard avoidance/detection (9 hazards), average pedestrian recognition distance (in meters), lane keeping (percentage of time inside the lane) and the inverse of driving lap time (in seconds).). Equal weighting was assigned to each measure. The individual Z scores were transformed (inverted) such that positive Z scores relate to better performance than the mean. Z scores follow a standard normal distribution (ranging from minus infinity to positive infinity). Overall Z score for night time driving was reported for each study lens.|15 Minutes Post Lens Fitting|All subjects that completed the study without a major protocol violation.|||Z-Score||Standard Deviation|Mean
2531786|NCT03330041|Secondary|Erythema|If one half of the scar has more associated erythema, this will be noted number of people with erythema after treatment will be reported|3 months following procedure||||Participants|||Count of Participants
2531788|NCT03330041|Primary|Patient Posas Score|Scale name: Patient Observer Scar Assessment Score. Scale measures six parameters of scars, each using a 10-point scoring system (the six categories are summed to achieve the POSAS score - totals range from 6 to 60), with 1 representing normal skin & 10 representing the most severe scar imaginable.|3 months following procedure||||score on a scale||Standard Deviation|Mean
2531789|NCT03329885|Primary|Inhibition at Time t [I(t)] (Part B)|Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters|Part B : Days 16, 20, and 24|All participants who received at least 1 dose of BMS-986251 or placebo and had any available concentration-time data for the PD assessments. Additionally, the evaluable PD population was defined as participants who had adequate PD profiles.|||Percent inhibition||Standard Deviation|Mean
2531790|NCT03329885|Secondary|Pre-dose Inhibition [I(Pre)] (Part B)|Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters|Part B : Days 2, 4, 7, and 14|All participants who received at least 1 dose of BMS-986251 or placebo and had any available concentration-time data for the PD assessments. Additionally, the evaluable PD population was defined as participants who had adequate PD profiles.|||Percent inhibition||Standard Deviation|Mean
2531791|NCT03329885|Secondary|Time of Inhibition Above 90% [t(I>90%)]|Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters|Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24|All participants who received at least 1 dose of BMS-986251 or placebo and had any available concentration-time data for the PD assessments. Additionally, the evaluable PD population was defined as participants who had adequate PD profiles.|||h||Standard Deviation|Mean
2531792|NCT03329885|Secondary|Time of Inhibition Above 50% [t(I>50%)]|Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters|Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24|All participants who received at least 1 dose of BMS-986251 or placebo and had any available concentration-time data for the PD assessments. Additionally, the evaluable PD population was defined as participants who had adequate PD profiles.|||h||Standard Deviation|Mean
2531793|NCT03329885|Secondary|Time of Maximum Observed Inhibition [t(Imax)]|Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters|Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24|All participants who received at least 1 dose of BMS-986251 or placebo and had any available concentration-time data for the PD assessments. Additionally, the evaluable PD population was defined as participants who had adequate PD profiles.|||h||Full Range|Median
2531794|NCT03329885|Secondary|Maximum Observed Inhibition [I(Max)]|Summary of IL-17 Inhibition in Whole Blood Pharmacodynamic (PD) Parameters|Part A: Days 1, 2, 3, 5, 7, 11 ; Part B : Day 1, 2, 16, 20, 24|All participants who received at least 1 dose of BMS-986251 or placebo and had any available concentration-time data for the PD assessments. Additionally, the evaluable PD population was defined as participants who had adequate PD profiles.|||Percent inhibition||Standard Deviation|Mean
2531795|NCT03329885|Primary|Pre-dose Plasma Concentration (Cpre) (Part B)|PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified|Part B : Days 2-14|All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.|||ng/mL||Standard Deviation|Mean
2531796|NCT03329885|Primary|Ratio of Cmax Following Last Dose to Cmax Following First Dose [AR(Cmax)] (Part B)|PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified|Part B : Day 14|All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.|||Ratio||Standard Deviation|Mean
2531797|NCT03329885|Primary|Ratio of AUC(0-24) Following Last Dose to AUC(0-24) Following First Dose [AR[AUC(0-24)]] (Part B)|PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified|Part B : Day 14|All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.|||Ratio||Standard Deviation|Mean
2531798|NCT03329885|Primary|Area Under the Concentration-time Curve Over 24 Hours (One Dosing Interval) [AUC(0-24)] (Part B)|PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified|Part B : Days 1 and Day 14|All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.|||ng.h/mL||Standard Deviation|Mean
2531799|NCT03329885|Primary|Renal Clearance [CL(R)]|Summary of BMS-986251 Excretion Parameters in Urine. PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified|Part A: Days 1, 2, 3, 4, 5, 6, 7 ; Part B : Day 14|All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.|||L/h||Standard Deviation|Mean
2531800|NCT03329885|Primary|Amount Excreted Unchanged in Urine (% of Dose) [Fe(Urine)%]|Summary of BMS-986251 Excretion Parameters in Urine. PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified|Part A: Days 1, 2, 3, 4, 5, 6, 7 ; Part B : Day 14|All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.|||Percentage of dose||Standard Deviation|Mean
2531801|NCT03329885|Primary|Cumulative Urinary Excretion (of the Unchanged Drug) [Ae(t)]|Summary of BMS-986251 Excretion Parameters in Urine. PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified|Part A: Days 1, 2, 3, 4, 5, 6, 7 ; Part B : Day 14|All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.|||mg||Standard Deviation|Mean
2531802|NCT03329885|Primary|Apparent Volume of Distribution at Terminal Phase [V(z)/F]|PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified|Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 14|All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.|||L||Standard Deviation|Mean
2532374|NCT03307005|Primary|Sleep Latency|Mean change in sleep latency on second sleep study minus sleep latency on the first sleep study. Lower values suggest faster sleep onset. Sleep latency is measured in minutes.|1 week||||minutes||Full Range|Mean
2531803|NCT03329885|Primary|Apparent (Oral) Clearance (CL/F) Calculated as Dose/[AUC(0-inf)] for Single Dose|PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified|Part A: Day 1, Part B: Day 14|All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.|||L/h||Standard Deviation|Mean
2531804|NCT03329885|Primary|Terminal Elimination Half-life, Calculated as 0.693/Kel [t(1/2)]|PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified|Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 14|All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.|||h||Standard Deviation|Mean
2531805|NCT03329885|Primary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(0-inf)] (Part A)|PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified|Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11|All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.|||ng.h/mL||Standard Deviation|Mean
2531806|NCT03329885|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-t)]|PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified|Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 1 and 14|All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.|||ng.h/mL||Standard Deviation|Mean
2531807|NCT03329885|Primary|Time of Maximum Observed Plasma Concentration (Tmax)|PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified|Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 1 and 14|All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.|||h||Full Range|Median
2531808|NCT03329885|Primary|Maximum Observed Plasma Concentration (Cmax)|PK parameters were derived from BMS-986251 concentration versus time data measured at the time points specified|Part A: Days 1, 2, 3, 4, 5, 6, 7, 9, 11; Part B : Day 1 and 14|All participants who received at least 1 dose of BMS-986251 and had any available concentration-time data. Additionally, the evaluable PK population was defined as participants who had adequate PK profiles.|||ng/mL||Standard Deviation|Mean
2531809|NCT03329885|Primary|Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Parameters|"Hematology: Hemoglobin, Hematocrit, Total leukocyte count, including differential Platelet count, Red blood cell count, Reticulocyte count; Chemistry:~Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Total bilirubin, Direct bilirubin, Alkaline phosphatase, Lactate dehydrogenase , (LDH), Creatinine, Urea, Uric acid, Fasting glucose, High sensitivity C-reactive protein (hs-CRP), Total protein, Albumin Sodium, Potassium, Chloride, Calcium Inorganic phosphate, Magnesium, Creatine kinase, Creatinine clearance (CLcr)- screening only, Cholesterol Triglycerides, High-density lipoprotein (HDL), Low-density lipoprotein (LDL), Urinalysis: Protein, Glucose, Blood Leukocyte esterase, Specific gravity, pH,Microscopic examination of the sediment if blood, protein or leukocytes esterase are positive on the dipstick; Other Analyses: Urine test for alcohol, Urine test for drugs of abuse, Pregnancy test"|Part A: Days 2, 4, 7 and 11; Part B: Days 3, 7, 10, 14, 16, 24|All participants who had received at least one dose of BMS-986251 or placebo.|||Participants|||Count of Participants
2531810|NCT03329885|Primary|Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters|The following ECG parameters were recorded: heart rate, PR-interval, QRS-duration, QT-interval, QTcinterval, (Fridericia's) and the interpretation of the ECG profile by the Investigator|Part A: Days 1, 2, 3,5, 7 and 11; Part B: Days 1, 2, 4, 6, 8, 10, and 12,24|All participants who had received at least one dose of BMS-986251 or placebo.|||Participants|||Count of Participants
2531811|NCT03329885|Primary|Number of Participants With Potentially Clinically Significant Changes in Vital Signs|Vital signs (Systolic and diastolic blood pressure and pulse) were recorded after the participant had been resting for at least 5 minutes in the supine position.|Part A: Days 1, 2, 3, 4, 5, 6, 7, 9 and 11; Part B: Days 1, 2-13, 15, 16, 18, 20, 24|All participants who had received at least one dose of BMS-986251 or placebo.|||Participants|||Count of Participants
2531812|NCT03329885|Primary|Number of Participants That Experienced the Following: Serious Adverse Events (SAEs), Death or an Adverse Event (AE) Leading to Study Discontinuation|An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with the treatment. A Serious Adverse Event is defined as any untoward medical occurrence that, at any dose results in death or is life-threatening or requires inpatient hospitalization|AEs: Day 1 to Day 11 (Part A), Day 1 to Day 24 (Part B); SAEs: Day -21 to within 30 days of discontinuation of dosing (Part A), Day -21 to within 30 days of discontinuation of dosing (Part B)|All participants who had received at least one dose of BMS-986251 or placebo.|||Participants|||Count of Participants
2531813|NCT03329573|Secondary|Temperature at Indicated Time-point Under Fasting Condition|Vital sign including temperature was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.|Day 11|Safety Population|||Celsius||Standard Deviation|Mean
2531814|NCT03329573|Secondary|Temperature at Indicated Time-point Under Fed Condition|Vital sign including temperature was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.|Day 11|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Celsius||Standard Deviation|Mean
2531815|NCT03329573|Secondary|RR at Indicated Time-point Under Fasting Condition|Vital sign including RR was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.|Day 11|Safety Population|||Breaths per minute||Standard Deviation|Mean
2532584|NCT03300674|Primary|Improvement in 0-10 Pain Scale Between Baseline and 90 Minutes|Participants were asked to describe their pain on a scale from 0 to 10 with 0= no pain and 10= the worst pain imaginable|90 minutes||||units on a scale||Standard Deviation|Mean
2531816|NCT03329573|Secondary|Respiratory Rate (RR) at Indicated Time-point Under Fed Condition|Vital sign including RR was measured at the indicated time-point and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.|Day 11|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Breaths per minute||Standard Deviation|Mean
2531817|NCT03329573|Secondary|Pulse Rate (PR) at Indicated Time-points Under Fasting Condition|Vital sign including PR was measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.|Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16|Safety Population|||Beats per minute||Standard Deviation|Mean
2531818|NCT03329573|Secondary|Pulse Rate (PR) at Indicated Time-points Under Fed Condition|Vital sign including PR was measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.|Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Beats per minute||Standard Deviation|Mean
2531819|NCT03329573|Secondary|DBP and SBP at Indicated Time-points Under Fasting Condition|Vital signs including DBP and SBP were measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.|Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16|Safety Population|||Millimeters of mercury||Standard Deviation|Mean
2531820|NCT03329573|Secondary|Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) at Indicated Time-points Under Fed Condition|Vital signs including DBP and SBP were measured at the indicated time-points and summarized during the study to evaluate the safety of the participants. Data has been presented treatment-wise.|Day 1 (post-dose), Day 2 (post-dose), Day 3, Day 4, Day 5, Day 11, Day 12 (pre-dose), Day 12 (post-dose), Day 13 (post-dose), Day 14, Day 15, Day 16|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Millimeters of mercury||Standard Deviation|Mean
2531821|NCT03329573|Secondary|Number of Participants With Clinically Significant Abnormal Findings for ECG Parameters Under Fasting Condition|A single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTc intervals. Clinically significant abnormal ranges were: heart rate: lower :<50 beats per minute and upper: >110 beats per minute; QT: Upper: >400 msec; QTc: Upper: >450 msec; PR: lower: <110 msec and upper: >220 msec; QRS: lower: <60 msec and upper: >120 msec. The number of participants with abnormal findings for ECG parameters have been presented. Data has been presented treatment-wise.|Baseline (Day-7 to Day -1) and Day 16|Safety Population|||Participants|||Count of Participants
2531822|NCT03329573|Secondary|Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters Under Fed Condition|A single 12-lead ECGs was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QT corrected (QTc) intervals. Clinically significant abnormal ranges were: heart rate: lower:<50 beats per minute and upper: >110 beats per minute; QT: Upper: >400 milliseconds (msec); QTc: Upper: >450 msec; PR: lower: <110 msec and upper: >220 msec; QRS: lower: <60 msec and upper: >120 msec. The number of participants with abnormal findings for ECG parameters have been presented. Data has been presented treatment-wise.|Baseline (Day-7 to Day -1) and Day 16|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2531823|NCT03329573|Secondary|Number of Participants With Urinalysis Results by Dipstick Method Under Fasting Condition|Urine samples were collected to assess urine occult blood, urine glucose, urine ketones, urine protein and monitor urine pH. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters (except urine pH) were recorded as negative and positive, indicating proportional concentrations in the urine sample. pH is a measure of hydrogen ion concentration and is used to determine the acidity or alkalinity of urine. Urine pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 6.5, 7 or 8. Data has been presented treatment-wise.|Baseline (Day-7 to Day -1) and Day 16|Safety Population|||Participants|||Count of Participants
2531824|NCT03329573|Secondary|Number of Participants With Urinalysis Results by Dipstick Method Under Fed Condition|Urine samples were collected to assess urine occult blood, urine glucose, urine ketones, urine protein and monitor urine potential of hydrogen (pH). The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters (except urine pH) were recorded as negative and positive, indicating proportional concentrations in the urine sample. pH is a measure of hydrogen ion concentration and is used to determine the acidity or alkalinity of urine. Urine pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Dipstick test results for pH were presented as number of participants having pH value as 5, 6, 6.5, 7 or 8. Data has been presented treatment-wise.|Baseline (Day-7 to Day -1) and Day 16|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2531832|NCT03329573|Secondary|Terminal Elimination Half-life (t1/2) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition|Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI have been presented.|Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.|||Hours||95% Confidence Interval|Geometric Mean
2533568|NCT03265132|Secondary|Proportion of Patients Who Have Initiated Tapering of Glucocorticoids.|Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available|From Week 2 to Week12|||||||
2531825|NCT03329573|Secondary|Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition|Blood samples were collected to analyze; Hct, Hb, erythrocytes and platelets. PCI ranges were Hct (Male [low: <0.03 proportion of red blood cells in blood and high: >0.54 proportion of red blood cells in blood] and Female [low: <0.04 proportion of red blood cells in blood and high: >0.54 proportion of red blood cells in blood]), Hb (Male [low: <110 grams per liter and high: >180 grams per liter) and Female [low: <100 grams per liter and high: >170 grams per liter]), erythrocytes (Male [low: <4.5x10^12 cells per liter and high: >5.5x10^12 cells per liter] and Female [low: <4 x10^12 cells per liter and high: >5 x10^12 cells per liter]) and platelets (low: <80x10^9 cells per liter and high: >400x10^9 cells per liter). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.|Day 16|Safety Population|||Participants|||Count of Participants
2531826|NCT03329573|Secondary|Number of Participants With Hematology Laboratory Values Relative to PCI Criteria on Day 16 Under Fed Condition|Blood samples were collected to analyze; hematocrit(Hct),hemoglobin(Hb),erythrocytes and platelets. PCI ranges; Hct(Male[low: <0.03 proportion of red blood cells in blood and high: >0.54 proportion of red blood cells in blood] and Female[low: <0.04 proportion of red blood cells in blood and high: >0.54 proportion of red blood cells in blood]),Hb(Male [low: <110 grams per liter and high: >180 grams per liter) and Female[low: <100 grams per liter and high: >170 grams per liter]),erythrocytes(Male [low: <4.5x10^12 cells per liter and high: >5.5x10^12 cells per liter] and Female[low: <4 x10^12 cells per liter and high: >5 x10^12 cells per liter]) and platelets(low: <80x10^9 cells per liter and high: >400x10^9 cells per liter). Participants were counted in the category that their value changed to(low, normal or high). If values were unchanged(example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category.Data has been presented treatment-wise.|Day 16|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Participants|||Count of Participants
2531827|NCT03329573|Secondary|Number of Participants With Chemistry Laboratory Values Relative to PCI Criteria on Day 16 Under Fasting Condition|Blood samples were collected to analyze the clinical chemistry laboratory parameters; ALT, albumin, ALP, AST, calcium, creatinine, glucose, Pot and sodium. PCI ranges were ALT (high: >=2 times ULN U/L), albumin (low: <30 grams per liter), ALP (low: <20 IU/L and high: >200 IU/L), AST (high: >=2 times ULN U/L), calcium (low: <2 mmol/L and high: >2.75 mmol/L), creatinine (high: >133 micromoles per liter), glucose (low: <3 mmol/L and high: >9 mmol/L), Pot (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.|Day 16|Safety Population|||Participants|||Count of Participants
2531828|NCT03329573|Secondary|Number of Participants With Chemistry Laboratory Values Relative to Potential Clinical Importance (PCI) Criteria on Day 16 Under Fed Condition|Blood samples were collected to analyze the clinical chemistry laboratory parameters; alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST),calcium,creatinine, glucose, potassium (Pot) and sodium. PCI ranges were ALT (high: >=2 times upper limit of normal [ULN] units per liter [U/L]),albumin (low: <30 grams per liter),ALP (low: <20 international units per liter [IU/L] and high: >200 IU/L), AST (high: >=2 times ULN U/L),calcium (low: <2 millimoles per liter [mmol/L] and high: >2.75 mmol/L),creatinine (high: >133 micromoles per liter), glucose (low: <3 mmol/L and high: >9 mmol/L), Pot (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Participants were counted in the category that their value changed to (low, normal or high). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change' category. Data has been presented treatment-wise.|Day 16|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Participants|||Count of Participants
2531829|NCT03329573|Secondary|Number of Participants With Non-SAE and SAEs Under Fasting Condition|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function. Data has been presented treatment-wise.|Up to Day 26|Safety Population|||Participants|||Count of Participants
2531830|NCT03329573|Secondary|Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Under Fed Condition|An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function. Data has been presented treatment-wise.|Up to Day 26|Safety Population. Safety Population comprised of all randomized participants who received at least one dose of study treatment. Only those participants with data available at the specified data points were analyzed.|||Participants|||Count of Participants
2531831|NCT03329573|Secondary|t1/2 of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition|Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI have been presented.|Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.|||Hours||95% Confidence Interval|Geometric Mean
2531858|NCT03328208|Other Pre-specified|Pain During Dental Treatment|Time course of pain as measured by self-report on a 0-10 scale with 0=no pain at all and 10=worst pain possible (average over 10 minute intervals)|Up to 120 min||||units on a scale||Standard Deviation|Mean
2531833|NCT03329573|Secondary|Lambda z of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition|Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI of Lambda z have been presented.|Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.|||Per hour||95% Confidence Interval|Geometric Mean
2531834|NCT03329573|Secondary|Terminal Elimination Rate Constant (Lambda z) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition|Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Geometric mean and 95% CI of Lambda z have been presented.|Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.|||Per hour||95% Confidence Interval|Geometric Mean
2531835|NCT03329573|Secondary|Tmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition|Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Median and full range of Tmax have been presented.|Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.|||Hours||Full Range|Median
2531836|NCT03329573|Secondary|Time to Reach Maximum Observed Concentration (Tmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition|Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Median and full range of Tmax have been presented.|Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period|Pharmacokinetic Population. PK Population comprised of all randomized participants received at least one dose of study treatment and provided at least one evaluable PK concentration data. Only those participants with data available at the specified data points were analyzed.|||Hours||Full Range|Median
2531837|NCT03329573|Primary|Cmax of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition|Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for Cmax.|Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period|BE analysis Population.|||Nanogram per milliliter||90% Confidence Interval|Geometric Mean
2531838|NCT03329573|Primary|Maximum Observed Concentration (Cmax) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition|Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for Cmax.|Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period|BE analysis Population|||Nanogram per milliliter||90% Confidence Interval|Geometric Mean
2531839|NCT03329573|Primary|AUC(0-t) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition|Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-t).|Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period|BE analysis Population|||Hour*nanogram per milliliter||90% Confidence Interval|Geometric Mean
2531840|NCT03329573|Primary|Area Under the Concentration-time Curve From Administration Extrapolated to the Last Time of Quantifiable Concentration (AUC[0-t]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition|Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-t).|Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period|BE analysis Population|||Hour*nanogram per milliliter||90% Confidence Interval|Geometric Mean
2531841|NCT03329573|Primary|AUC(0-infinity) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fasting Condition|Blood samples were collected at designated timepoints. PK parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of BE. Point estimate and associated adjusted 90% CI of difference between both the treatments were provided for AUC(0-infinity).|Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period|BE analysis Population. Only those participants with data available at the specified data points were analyzed.|||Hour*nanogram per milliliter||90% Confidence Interval|Geometric Mean
2531859|NCT03328208|Other Pre-specified|Pain the End of the Waiting Room Time (Change as Compared to Beginning of the Waiting Room Time)|Pain as measured by self-report on a 0-10 scale with 0=no pain at all and 10=worst pain possible; change from the beginning to the end of the waiting room time|Up to 60 min||||units on a scale||95% Confidence Interval|Mean
2553984|NCT02765269|Secondary|Users' Satisfaction (Questionnaire)|Patients will be asked to complete a questionnaire after patients use it for 2 weeks.|2 weeks||||participants|||Number
2531842|NCT03329573|Primary|Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of Paroxetine Following Single Oral Dose in Healthy Chinese Participants Under Fed Condition|Blood samples were collected at designated time points. Pharmacokinetic (PK) parameters of Paroxetine were calculated using non-compartmental methods. Statistical analysis of PK parameters was done using mixed effect model for evaluation of bioequivalence (BE). Point estimate and associated adjusted 90% confidence interval (CI) of difference between both the treatments were provided for AUC(0-infinity).|Pre-dose, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 36 hours, 48 hours, 72 hours and 96 hours post-dose in each treatment period|BE analysis Population. BE analysis Population comprised of all randomized participants who completed all the planned treatments and provided at least one evaluable primary PK parameter data from both period 1 and period 2. Only those participants with data available at the specified data points were analyzed.|||Hour*nanogram per milliliter||90% Confidence Interval|Geometric Mean
2531843|NCT03329209|Secondary|Percentage of Participants With Positive Neutralizing AVA||Day 1 pre-dose and at multiple time points (up to Day 127) post-dose|The safety analysis set consisted of all participants who were enrolled and received 1 dose of study drug.|||percentage of participants|||Number
2531844|NCT03329209|Secondary|Percentage of Participants With Positive Anti-vedolizumab Antibody (AVA)||Day 1 pre-dose and at multiple time points (up to Day 127) post-dose|The safety analysis set consisted of all participants who were enrolled and received 1 dose of study drug.|||percentage of participants|||Number
2531845|NCT03329209|Primary|AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Vedolizumab||Day 1 pre-dose and at multiple time points (up to Day 127) post-dose|The PK analysis set consisted of all participants who received study drug and had at least 1 measurable serum concentration.|||day*mcg/mL||Standard Deviation|Geometric Mean
2531846|NCT03329209|Primary|AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vedolizumab||Day 1 pre-dose and at multiple time points (up to Day 127) post-dose|The PK analysis set consisted of all participants who received study drug and had at least 1 measurable serum concentration.|||day*microgram per milliliter(day*mcg/mL)||Standard Deviation|Geometric Mean
2531847|NCT03329209|Primary|Cmax: Maximum Observed Serum Concentration for Vedolizumab||Day 1 pre-dose and at multiple time points (up to Day 127) post-dose|The pharmacokinetic (PK) analysis set consisted of all participants who received study drug and had at least 1 measurable serum concentration.|||microgram per milliliter (mcg/mL)||Standard Deviation|Geometric Mean
2531848|NCT03328949|Secondary|Number of Participants Which Experienced Cardiac Death|Number of patients who experienced a cardiac death at 30 days post-procedure.|30 days post-procedure||||Participants|||Count of Participants
2531849|NCT03328949|Secondary|Number of Participants With Angiographic Success|Angiographic success defined as success in facilitating stent delivery with <50% residual stenosis and without serious angiographic complications. Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.|During procedure||||Participants|||Count of Participants
2531850|NCT03328949|Secondary|Number of Participants With Clinical Success|"Performance will be assessed by the ability of the Lithotripsy System to produce acceptable residual stenosis (<50%) after stenting with no evidence of in-hospital MACE. Each patient that achieves both of these requirements will be considered a clinical success, and the rate of clinical success among subjects will be evaluated."|During procedure through hospital discharge||||Participants|||Count of Participants
2531851|NCT03328949|Primary|Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)|"The primary endpoint is the frequency of in-hospital major adverse cardiac events (MACE). MACE is defined as the following:~Cardiac death~Myocardial Infarction - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave~TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure"|Post-procedure through hospital discharge|No imputation of or adjustments for missing data were performed for the primary analysis. The population for all analysis was the Intent-To-Treat (ITT) analysis set. ITT was defined as those subjects who had insertion of the IVL catheter attempted, defined as the point of enrollment.|||Participants|||Count of Participants
2531852|NCT03328624|Primary|Comfort and Patient Acceptance|"FULL SCALE NAME: Wearability, comfort, and acceptance of the DVT cuff Scale. Created a likert-type scale in RedCAP with values from 0 to 10, with higher score equaling better outcome.~TIME FRAME: Each participant wore the DVT cuff under study for 20 minutes, and evaluated their experience using the scale above.~Evaluated through User Questionnaire: Recovery Force DVT Cuff - Post-Demonstration Patient Questionnaire; and subject interview"|1 day||||score on a scale||Standard Deviation|Mean
2531853|NCT03328208|Other Pre-specified|Patient Satisfaction|Patient satisfaction on a questionnaire at the end of the outpatient clinic visit, modeled after Press Ganey and averaged over 7 domains and groups. Assessment on Likert Scales from 1 (worst)-5 (best)|Up to 3 hrs||||units on a scale||Full Range|Mean
2531854|NCT03328208|Other Pre-specified|Number of Participants Receiving New Prescriptions for Drugs|Participants receiving new prescriptions for drugs at the end of their visit for the subsequent week (alone or in combination opioids, non-opioid analgesics, anxiolytics, muscle relaxants, triptan, and/or anticonvulsants)|7 days|All enrolled participants|||participants|||Number
2531855|NCT03328208|Other Pre-specified|Average Maximal Pain During 1 Week After Treatment|Average of maximal daily pain as measured daily by self-report on a 0-10 scale with 0=no pain at all and 10=worst pain possible|7 days|Participants who returned their diary card packages|||units on a scale||Standard Deviation|Mean
2531856|NCT03328208|Other Pre-specified|Average Maximal Anxiety During 1 Week After Dental Treatment|Average maximal daily anxiety as measured daily by self-report on a 0-10 scale with 0=no anxiety at all and 10=worst anxiety possible|7 days|Participants who returned their diary card packages|||units on a scale||Standard Deviation|Mean
2531857|NCT03328208|Other Pre-specified|Anxiety During Dental Treatment|Time course of anxiety as measured by self-report on a 0-10 scale with 0=no anxiety at all and 10=worst anxiety possible (average over 10 minute intervals)|Up to 120 min||||units on a scale||Standard Deviation|Mean
2536608|NCT03162458|Secondary|Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)|based on patient diary data|On Days 2-5 of the treatment|Intention to treat set|||percentage of participants|||Number
2531862|NCT03328208|Secondary|Number of Days to Enroll 60 Participants|Feasibility measure defined as the ability to enroll 60 participants by day 150 after initiation of recruitment in the clinic (=day 1). Outcome measure are numbers of office days from the start of enrollment|Up to 150 days|Number of participants within the cohort of the first 60 participants|||Days|||Number
2531863|NCT03328208|Primary|Number of Participants With Complete On-Site Data Sets|Feasibility defined as the ability to obtain complete on-site data sets from at least 90% of participants enrolled (with at least 40% from patients in the app group and at least 40% from patients in the control group).|Duration of outpatient clinic visit (up to 2 hrs)|Participants enrolled|||Participants|||Count of Participants
2531864|NCT03328182|Primary|Usability of Study Product|The usability of the study product at application and at removal.|At application and product removal (maximum 29 days of patient wearing product)||||Participants|||Count of Participants
2531865|NCT03328182|Primary|Overall Acceptability With Study Product|The overall acceptability relating to general experience with the study product during use will be rated with a 5-point Likert scale ranging from 1=Very Unacceptable to 5=Very Acceptable|At product removal (maximum 29 days of patient wearing product)||||Participants|||Count of Participants
2531866|NCT03327402|Secondary|Area Under the Concentration-Time Curve From Time Sixteen Hours to Twenty-Four Hours Postdose (AUC16-24) of Plasma d-Amphetamine and Plasma l-Amphetamine|Area under the concentration-time curve from time sixteen hours to twenty-four hours postdose (AUC16-24) in plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method. Values displayed do not necessarily reflect the actual precision obtained.|Week 4: 16, 24 hours (Day 8) Postdose on Day 7|PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2531867|NCT03327402|Secondary|Area Under the Concentration-Time Curve From Time Twelve Hours to Sixteen Hours Postdose (AUC12-16) of Plasma d-Amphetamine and Plasma l-Amphetamine|Area under the concentration-time curve from time twelve hours to sixteen hours postdose (AUC12-16) in plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method. Values displayed do not necessarily reflect the actual precision obtained.|Week 4: 12, 16 hours Postdose on Day 7|PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2531868|NCT03327402|Secondary|Area Under the Concentration-Time Curve From Time Five Hours to Twelve Hours Postdose (AUC5-12) of Plasma d-Amphetamine and Plasma l-Amphetamine|Area under the concentration-time curve from time five hours to twelve hours postdose (AUC5-12) in plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method.Values displayed do not necessarily reflect the actual precision obtained.|Week 4: 5, 8, 12 hours Postdose on Day 7|PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2531869|NCT03327402|Secondary|Observed Analyte Concentration at 24 Hours After Dose Administration (C24) of Plasma d-Amphetamine and Plasma l- Amphetamine|Observed analyte concentration of plasma d-amphetamine and plasma l-amphetamine at 24 hours after dose administration were evaluated using rich sampling collection method.Values displayed do not necessarily reflect the actual precision obtained.|Week 4: 24 hours (Day 8) Postdose on Day 7|PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2531870|NCT03327402|Secondary|Observed Analyte Concentration at 16 Hours After Dose Administration (C16) of Plasma d-Amphetamine and Plasma l- Amphetamine|Observed analyte concentration of plasma d-amphetamine and plasma l-amphetamine at 16 hours after dose administration were evaluated using rich sampling collection method.Values displayed do not necessarily reflect the actual precision obtained.|Week 4: 16 hours (Day 8) Postdose on Day 7|PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2531871|NCT03327402|Secondary|Observed Analyte Concentration at 12 Hours After Dose Administration (C12) of Plasma d-Amphetamine and Plasma l-Amphetamine|Observed analyte concentration of plasma d-amphetamine and plasma l-amphetamine at 12 hours after dose administration were evaluated using rich sampling collection method. Values displayed do not necessarily reflect the actual precision obtained.|Week 4: 12 hours (Day 8) Postdose on Day 7|PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2531872|NCT03327402|Primary|Number of Participants With a Positive Response in Columbia-Suicide Severity Rating Scale (C-SSRS) at Final On-Treatment Assessment|C-SSRS was a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts (suicidal ideation) and suicidal behaviors during the assessment period needed to be determine if a suicide-related thought or behavior were occurred. The assessment was done by the nature of the responses, not by a numbered scale. FoTA was defined as the last valid assessment obtained after baseline and while on IP (on or before 2 days after the last dose date).|FoTA (up to Day 30)|Safety Set consisted of all enrolled participants who had taken at least one dose of investigational product.|||Participants|||Count of Participants
2532018|NCT03321253|Primary|Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months|Foveal and pericentral pigment optical density was measured by using color perimetry technique and recorded as log unit before Nd: YAG laser posterior capsulotomy, at 1 week, 1 month and 2 months|2 months||||log unit||Standard Deviation|Mean
2553987|NCT02764970|Secondary|Motion Artifacts|Counted linear misalignments in the ap projection|intraoperative||||linear misalignments in the ap projectio||Standard Deviation|Mean
2531873|NCT03327402|Primary|Total Sleep Disturbance Score of Children's Sleep Habits Questionnaire (CSHQ ) at Final On-Treatment Assessment|The CSHQ was a validated, retrospective, parent-reported sleep screening tool. The questionnaire consisted of 35 items that yield a TSD score, as well as 8 subscale scores, including bedtime resistance, sleep duration, parasomnias, sleep disordered breathing, night wakings, daytime sleepiness, sleep anxiety, and sleep onset delay. Each item receives a score from 1 (meaning the problem occurs rarely) to 3 (meaning the problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: Bedtime Resistance: 6 to 18, Sleep Onset Delay: 1 to 3, Sleep Duration: 3 to 9, Sleep Anxiety: 4 to 12, Night Wakings: 3 to 9, Parasomnias: 7 to 21, Disordered Breathing: 3 to 9, Daytime Sleepiness: 8 to 24, and Total Disturbance (items from all scales): 33 to 99. A negative value indicated less sleep disturbance.|FoTA (up to Day 30)|Safety set consisted of all enrolled participants who had taken at least one dose of investigational product. FoTA was defined as the last valid assessment obtained after baseline and while on IP (on or before 2 days after the last dose date).|||Units on scale||Standard Deviation|Mean
2531874|NCT03327402|Primary|Length of Time Sleeping Per Night Assessed by PSQ at Final On-Treatment Assessment|The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. FoTA was defined as the last valid assessment obtained after baseline and while on IP (on or before 2 days after the last dose date).|FoTA (up to Day 30)|Safety set consisted of all enrolled participants who had taken at least one dose of investigational product.|||hours||Standard Deviation|Mean
2531875|NCT03327402|Primary|Length of Time to Fall Asleep Per Night Assessed by PSQ at Final On-Treatment Assessment|The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. FoTA was defined as the last valid assessment obtained after baseline and while on IP (on or before 2 days after the last dose date).|FoTA (up to Day 30)|Safety set consisted of all enrolled participants who had taken at least one dose of investigational product.|||minutes||Standard Deviation|Mean
2531876|NCT03327402|Primary|Length of Time Awake Per Night Assessed by PSQ at Final On-Treatment Assessment|The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. FoTA was defined as the last valid assessment obtained after baseline and while on IP (on or before 2 days after the last dose date).|FoTA (up to Day 30)|Safety set consisted of all enrolled participants who had taken at least one dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||minutes||Standard Deviation|Mean
2531877|NCT03327402|Primary|Number of Participants With Overall Quality of Sleep Assessed by Post Sleep Questionnaire (PSQ) at Final On-Treatment Assessment|The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. The assessment was done by the nature of the responses, not by a numbered scale. FoTA was defined as the last valid assessment obtained after baseline and while on IP (on or before 2 days after the last dose date).|FoTA (up to Day 30)|Safety set consisted of all enrolled participants who had taken at least one dose of investigational product.|||Participants|||Count of Participants
2531878|NCT03327402|Primary|Number of Participants With Clinically Significant Changes in Clinical Laboratory Results Reported as TEAEs|Clinical laboratory tests included biochemistry, endocrinology, hematology and urinalysis. Any change in clinical laboratory results which are deemed clinically significant by the investigator were reported as TEAE.|From start of study drug administration up to follow-up (up to 5 weeks)|Safety set consisted of all enrolled participants who had taken at least one dose of investigational product.|||Participants|||Count of Participants
2531879|NCT03327402|Primary|Change From Baseline in Weight at Final On-Treatment Assessment|Weight (in kilograms) was measured using a calibrated scale. Participant should be in light clothes and without shoes. FoTA was defined as the last valid assessment obtained after baseline and while on IP (on or before 2 days after the last dose date).|FoTA (up to Day 30)|Safety set consisted of all enrolled participants who had taken at least one dose of investigational product.|||kilogram (kg)||Standard Deviation|Mean
2531880|NCT03327402|Primary|Change From Baseline in Height at Final On-Treatment Assessment|Height (in centimeters) was measured using a stadiometer with the participant standing on a flat surface without shoes and with the chin parallel to the floor. Final on-treatment assessment (FoTA) was defined as the last valid assessment obtained after baseline and while on IP (on or before 2 days after the last dose date).|FoTA (up to Day 30)|Safety set consisted of all enrolled participants who had taken at least one dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||centimeter (cm)||Standard Deviation|Mean
2531881|NCT03327402|Primary|Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as TEAEs|12-lead ECG were evaluated. Any change in ECG assessments which are deemed clinically significant by the investigator were reported as TEAE.|From start of study drug administration up to follow-up (up to 5 weeks)|Safety set consisted of all enrolled participants who had taken at least one dose of investigational product.|||Participants|||Count of Participants
2531882|NCT03327402|Primary|Number of Participants With Clinically Significant Changes in Vital Signs Reported as TEAEs|Vital sign assessments included blood pressure, pulse, respiratory rate and body temperature. Any change in vital signs which were deemed clinically significant by the investigator were recorded as TEAE.|From start of study drug administration up to follow-up (up to 5 weeks)|Safety set consisted of all enrolled participants who had taken at least one dose of investigational product.|||Participants|||Count of Participants
2532019|NCT03320941|Secondary|Pharmacokinetics - Plasma Trough Concentrations of LIK066|Plasma trough concentrations of LIK066 were measured at Week 12 after daily administrations of LIK066 (2.5, 10, 25 and 50 mg).|Week 12|Safety set (SAF): the SAF includes all participants who received at least one dose of study medication.|||ng/mL||Standard Deviation|Mean
2553988|NCT02764970|Secondary|Radiation Dose|as calculated in mSv|intraoperative||||mSv||Standard Deviation|Mean
2531883|NCT03327402|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily had a causal relationship with this treatment. TEAEs was defined as AEs that start or deteriorate on or after the date of the first dose of investigational product (IP) and no later than 3 days following the last dose of IP.|From start of study drug administration up to follow-up (up to 5 weeks)|Safety set consisted of all enrolled participants who had taken at least one dose of investigational product.|||Participants|||Count of Participants
2531884|NCT03327402|Primary|Apparent Volume of Distribution (Vss/F) at Steady State of Plasma d-Amphetamine and Plasma l-Amphetamine|Apparent volume of distribution at steady state of plasma d-amphetamine and plasma l-amphetamine after oral dose administration were evaluated using rich sampling collection method.Values displayed do not necessarily reflect the actual precision obtained.|Week 4: Predose, 2, 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7|PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected.Here, number of participants analyzed signifies participants who were evaluable for this outcome measure at the specific categories. Sparse PK sampling group were excluded from the PK analysis.|||liter||Geometric Coefficient of Variation|Geometric Mean
2531885|NCT03327402|Primary|Terminal Half-life (t1/2) of Plasma d-Amphetamine and Plasma l-Amphetamine|Time required for the plasma drug concentration to reach half of its original value of plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method.Values displayed do not necessarily reflect the actual precision obtained.|Week 4: Predose, 2, 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7|PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure at the specific categories. Sparse PK sampling group were excluded from the PK analysis.|||hour||Full Range|Median
2531886|NCT03327402|Primary|Total Body Clearance (CL/F) for Extravascular Administration of Plasma d-Amphetamine and Plasma l-Amphetamine|Apparent total clearance of the plasma drug concentration of plasma d- amphetamine and plasma l-amphetamine after oral dose administration were evaluated using rich sampling collection method.Values displayed do not necessarily reflect the actual precision obtained.|Week 4: Predose, 2, 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7|PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis.|||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2531887|NCT03327402|Primary|Terminal Rate Constant (Lambda z) of Plasma d-Amphetamine and Plasma l-Amphetamine|Terminal Rate Constant of plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method.Values displayed do not necessarily reflect the actual precision obtained.|Week 4: Predose, 2, 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7|PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure at the specific categories. Sparse PK sampling group were excluded from the PK analysis.|||per hour||Geometric Coefficient of Variation|Geometric Mean
2531888|NCT03327402|Primary|Area Under the Concentration-Time Curve Over the Dosing Interval (24 Hours) at Steady State (AUCtau,ss) of Plasma d-Amphetamine and Plasma l-Amphetamine|Area under the concentration-time curve over the dosing interval (24 hours) at steady state of plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method. Values displayed do not necessarily reflect the actual precision obtained.|Week 4: Predose, 2, 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7|PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2531889|NCT03327402|Primary|Area Under the Concentration-Time Curve From Time of Dosing to the Last Measurable Concentration (AUClast) of Plasma d-Amphetamine and Plasma l-Amphetamine|Area under the concentration-time curve from time of dosing to the last measurable concentration of plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method. Values displayed do not necessarily reflect the actual precision obtained.|Week 4: Predose, 2, 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7|PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2531890|NCT03327402|Primary|Area Under the Concentration Time Curve From Time Five Hours to the Last Timepoint (AUC5-t) of Plasma d-Amphetamine and Plasma l-Amphetamine|Area under the concentration time curve from time five hours to the time of last quantifiable concentration of plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method.Values displayed do not necessarily reflect the actual precision obtained.|Week 4: 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7|PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2531891|NCT03327402|Primary|Area Under the Concentration-Time Curve From Time Zero Predose to Five Hours Postdose (AUC0-5) of Plasma d-Amphetamine and Plasma l-Amphetamine|Area under the concentration time curve from time zero predose to five hours postdose of plasma d-amphetamine and plasma d-amphetamine were evaluated using rich sampling collection method. Values displayed do not necessarily reflect the actual precision obtained.|Week 4: Predose, 2, 5 hours Postdose on Day 7|PK set consisted of all participants in the safety set for whom at least one post-dose PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2532499|NCT03305055|Primary|Mean Wound Care Pain|Average Pain across 14 sessions between the 2 groups and related outcome measures up to 40 days following study enrollment.|Up to 40 days|Data was not collected for the minimum threshold [per the statistical analysis plan] of 6-11 consecutive wound care sessions to assess this outcome measure||||||
2531892|NCT03327402|Primary|Area Under the Concentration-Time Curve From Time Zero to the Last Timepoint (AUC0-t) During Sample Collection of Plasma d-Amphetamine and Plasma l-Amphetamine|Area under the concentration-time curve from time zero to the last quantifiable concentration of plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method. Values displayed do not necessarily reflect the actual precision obtained.|Week 4: Predose, 2, 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7|PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis.|||hour*nanogram per milliliter (hr*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2531893|NCT03327402|Primary|Time to Reach Maximum Observed Plasma Drug Concentration (Tmax) During Dosing Interval of Plasma d-Amphetamine and Plasma l-Amphetamine|Time to reach maximum observed plasma drug concentration of plasma d-amphetamine and plasma l-amphetamine during a dosing interval were evaluated using rich sampling collection method. Values displayed do not necessarily reflect the actual precision obtained.|Week 4: Predose, 2, 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7|PK set consisted of all participants in the safety set for whom at least one post-dose PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis.|||hour||Full Range|Median
2531894|NCT03327402|Primary|Trough Plasma Drug Concentration Ctrough at Steady State (Ctrough,ss) of Plasma d-Amphetamine and Plasma l-Amphetamine|"Trough plasma drug concentration (predose concentrations collected at steady state) of plasma d-amphetamine and plasma l-amphetamine were evaluated using rich sampling collection method.~Values displayed do not necessarily reflect the actual precision obtained."|Predose on Day 1 and Day 28 and at 24 hours (Day 29) postdose on Day 28|PK set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis.|||ng/mL||Standard Deviation|Mean
2531895|NCT03327402|Primary|Maximum Plasma Drug Concentration (Cmax) Occurred at the Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of Plasma Dextroamphetamine (d-Amphetamine) and Plasma Levoamphetamine (l-Amphetamine)|Maximum plasma drug concentration occurred at time of maximum observed concentration of plasma d-amphetamine and plasma l-amphetamine during a dosing interval were evaluated using rich sampling collection method. Values displayed do not necessarily reflect the actual precision obtained.|Week 4: Predose, 2, 5, 8, 12, 16, 24 hours (Day 8), 48 hours (Day 9) Postdose on Day 7|Pharmacokinetic (PK) set consisted of all participants in the safety set for whom at least one PK blood sample was collected. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Sparse PK sampling group were excluded from the PK analysis.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2531896|NCT03327051|Secondary|Change in Peak Intensity of Metabolites of Interest Before and After VSL#3 Probiotic Administration (Placebo and VSL#3 Group).|"From week 0 to week 4, relative change in metabolites (e.g. short chain fatty acids, bile acid derivatives, flavonoids, amino acids) found in the GI track by mass spectrometry after ingesting VSL#3. Serum samples are assessed.~MZ = mass/charge ratio; RT = retention time. MZ/RT data were obtained by mass spectrometry analysis. These are metabolites of interest for the Placebo and VSL#3 group only."|Week 0 and Week 4|Participants in the Placebo and VSL#3 group who attended the week 4 visit are included in the analysis.|||MZ/RT||Standard Deviation|Mean
2531897|NCT03327051|Secondary|Change in Peak Intensity of the Metabolite 1H-Indole-4-carbaldehyde Before and After VSL#3 Probiotic Administration (Omeprazole and VSL #3).|"From week 0 to week 4, relative change in metabolites (e.g. short chain fatty acids, bile acid derivatives, flavonoids, amino acids) found in the GI track by mass spectrometry after ingesting VSL#3. Serum samples are assessed.~MZ = mass/charge ratio; RT = retention time. MZ/RT data were obtained by mass spectrometry analysis. This is a metabolite of interest for the Omeprazole and VSL#3 group only."|Week 0 and Week 4|Participants in the Omeprazole and VSL#3 group who attended the week 4 visit are included in the analysis.|||MZ/RT||Standard Deviation|Mean
2531898|NCT03327051|Secondary|Relative Abundance (Mean Value) of Most Abundant Bacterial Phylum Before and After VSL#3 Probiotic Administration|From week 0 to week 4, change in the relative abundance (percentage) of most common types of bacteria phyla normally found in the lower GI track (e.g. Firmicutes, Bacteroidetes, Actinobacteria and Proteobacteria) after ingesting VSL#3 in the presence or absence of omeprazole. Stool samples are assessed.|Week 0 and Week 4|Participants who attended the week 4 visit are included in the analysis.|||percentage of abundance||Standard Deviation|Mean
2531899|NCT03327051|Secondary|Number of Participants With Symptoms Related to VSL#3 Treatment.|Participants were asked to report symptoms of gastro-intestinal discomfort experienced within the last 28 days.|Week 0 through Week 4|Participants who attended the week 4 visit are included in the analysis.|||Participants|||Count of Participants
2531900|NCT03327051|Primary|Relative Abundance of VSL#3 Probiotic Bacterial Strains When Ingested in the Presence or Absence of the Proton Pump Inhibitor (PPI) Omeprazole at Week 4.|Relative abundance is reported as the percent of combined VSL #3 probiotic bacteria strains in the bacteria sample (S. thermophiles, B. breve, B. longum, B. infantis, L. acidophilus, L. plantarum, L. paracasei, L. delbrueckii subsp. bulgaricus) following their ingestion in the presence or absence of the gastric acid suppression drug omeprazole. Stool samples were assessed.|Week 4|Participants who attended the week 4 visit are included in the analysis.|||percentage of abundance||Standard Deviation|Mean
2531901|NCT03326986|Secondary|Change From Baseline in Heart Rate (HR) at 24 Hours|Assessment of the change from baseline in HR was obtained using a validated, semi-automated oscillometric device. Baseline was defined as the average of predose measurements. A measurement set was considered 2 HR measurements: baseline and 24 hours postdose. HR results are reported by dose taken. Placebo measurements are pooled over periods across panels. A positive number indicates an increase in HR and a negative number indicates a decrease in HR.|Baseline (Predose Day 1) and 24 hours postdose|All participants who received at least 1 dose of study treatment and had HR assessments at baseline and 24 hours postdose|||beats per minute|Measurement sets|Standard Error|Mean
2532500|NCT03304873|Primary|Number of Partcipants With MRSA Carriage at 4 Weeks Post Decolonization With Retapamulin or Placebo|Study visit for nasal/peri-rectal swabs|4 Weeks||||Participants|||Count of Participants
2531902|NCT03326986|Secondary|Change From Baseline in Heart Rate (HR) at 4 Hours|Assessment of the change from baseline in HR was obtained using a validated, semi-automated oscillometric device. Baseline was defined as the average of predose measurements. A measurement set was considered 2 HR measurements: baseline and 4 hours postdose. HR results are reported by dose taken. Placebo measurements are pooled over periods across panels. A positive number indicates an increase in HR and a negative number indicates a decrease in HR.|Baseline (Predose Day 1) and 4 hours postdose|All participants who received at least 1 dose of study treatment and had HR assessments at baseline and 4 hours postdose|||beats per minute|Measurement sets|Standard Error|Mean
2531903|NCT03326986|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) at 24 Hours|Assessment of the change from baseline in DBP was obtained using a validated, semi-automated oscillometric device. Baseline was defined as the average of predose measurements. A measurement set was considered 2 DBP measurements: baseline and 24 hours postdose. DBP results are reported by dose taken. Placebo measurements are pooled over periods across panels. A positive number indicates an increase in DBP and a negative number indicates a decrease in DBP.|Baseline (Predose Day 1) and 24 hours postdose|All participants who received at least 1 dose of study treatment and had DBP assessments at baseline and 24 hours postdose|||mmHg|Measurement sets|Standard Error|Mean
2531904|NCT03326986|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) at 4 Hours|Assessment of the change from baseline in DBP was obtained using a validated, semi-automated oscillometric device. Baseline was defined as the average of predose measurements. A measurement set was considered 2 DBP measurements: baseline and 4 hours postdose. DBP results are reported by dose taken. Placebo measurements are pooled over periods across panels. A positive number indicates an increase in DBP and a negative number indicates a decrease in DBP.|Baseline (Predose Day 1) and 4 hours postdose|All participants who received at least 1 dose of study treatment and had DBP assessments at baseline and 4 hours postdose|||mmHg|Measurement sets|Standard Error|Mean
2531905|NCT03326986|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) at 24 Hours|Assessment of the change from baseline in SBP was obtained using a validated, semi-automated oscillometric device. Baseline was defined as the average of predose measurements. A measurement set was considered 2 SBP measurements: baseline and 24 hours postdose. SBP results are reported by dose taken. Placebo measurements are pooled over periods across panels. A positive number indicates an increase in SBP and a negative number indicates a decrease in SBP.|Baseline (Predose Day 1) and 24 hours postdose|All participants who received at least 1 dose of study treatment and had SBP assessments at baseline and 24 hours postdose|||mmHg|Measurement sets|Standard Error|Mean
2531906|NCT03326986|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) at 4 Hours|Assessment of the change from baseline in SBP was obtained using a validated, semi-automated oscillometric device. Baseline was defined as the average of predose measurements. A measurement set was considered 2 SBP measurements: baseline and 4 hours postdose. SBP results are reported by dose taken. Placebo measurements are pooled over periods across panels. A positive number indicates an increase in SBP and a negative number indicates a decrease in SBP.|Baseline (Predose Day 1) and 4 hours postdose|All participants who received at least 1 dose of study treatment and had SBP assessments at baseline and 4 hours postdose|||mmHg|Measurement sets|Standard Error|Mean
2531907|NCT03326986|Secondary|MK-7252 Apparent Terminal Half-life (t½)|Blood samples were obtained predose (Day 1) and at designated times postdose to calculate the plasma MK-7252 t½ reported as Geometric Mean with Percent Geometric Coefficient of Variation. PK results were reported by dose taken in Panels A and B. For Panel C, PK results were reported by dose taken and by individual period. Periods in a panel were not conducted if it became evident that exposures at the escalated dosing would not adequately reach the projected PK target. Although the plasma t½ following a high-fat breakfast (fed state) was planned to be compared to the plasma t½ in the fasted stated in Panel C, the fed state dose was not administered.|Predose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 10, 12, 24, 48, and 72 hours postdose|All participants who received study treatment and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint. Periods (P) 4 and 5 of Panel C were not conducted; the planned 120 mg fed dose (P5) was not administered.|||hr||Geometric Coefficient of Variation|Geometric Mean
2531908|NCT03326986|Secondary|MK-7252 Time to Reach Maximal Concentration (Tmax)|Blood samples were obtained predose (Day 1) and at designated times postdose to calculate the plasma MK-7252 Tmax. PK results were reported by dose taken in Panels A and B. For Panel C, PK results were reported by dose taken and by individual period. Periods in a panel were not conducted if it became evident that exposures at the escalated dosing would not adequately reach the projected PK target. Although the plasma Tmax following a high-fat breakfast (fed state) was planned to be compared to the plasma Tmax in the fasted stated in Panel C, the fed state dose was not administered.|Predose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 10, 12, 24, 48, and 72 hours postdose|All participants who received study treatment and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint. Periods (P) 4 and 5 of Panel C were not conducted; the planned 120 mg fed dose (P5) was not administered.|||hr||Full Range|Median
2531909|NCT03326986|Secondary|MK-7252 Plasma Concentration at 24 Hours Postdose (C24hr)|Blood samples were obtained 24 hours postdose to calculate the plasma MK-7252 C24hr reported as back-transformed least squares mean and confidence interval calculated using a linear mixed effects model performed on natural log-transformed values. For participants in a given dose that had C24hr values less than the lower limit of quantification (LLOQ), the C24hr value was imputed as half x LLOQ. The LLOQ was 2.74 nmol/L. PK results were reported by dose taken in Panels A and B. For Panel C, PK results were reported by dose taken and by individual period. Periods in a panel were not conducted if it became evident that exposures at the escalated dosing would not adequately reach the projected PK target. Although the plasma C24hr following a high-fat breakfast (fed state) was planned to be compared to the plasma C24hr in the fasted stated in Panel C, the fed state dose was not administered.|24 hours postdose|All participants who received study treatment, complied with the protocol to ensure data were likely to exhibit effects of treatment according to the scientific model, and had data available for endpoint. Periods 4-5 of Panel C was not conducted and planned 120 mg fed dose not administered. Analysis was not performed due to values being <LLOQ.|||nmol/L||90% Confidence Interval|Geometric Least Squares Mean
2554594|NCT02756689|Secondary|Total Duration of Time From Rupture of Membranes Until Delivery||Assessed from baseline to delivery, up to 3 days||||hours||Standard Deviation|Mean
2531910|NCT03326986|Secondary|MK-7252 Plasma Concentration at 12 Hours Postdose (C12hr)|Blood samples were obtained 12 hours postdose to calculate the plasma MK-7252 C12hr reported as back-transformed least squares mean and confidence interval calculated using a linear mixed effects model performed on natural log-transformed values. For participants in a given dose that had C12hr values less than the lower limit of quantification (LLOQ), the C12hr value was imputed as half x LLOQ. The LLOQ was 2.74 nmol/L. PK results were reported by dose taken in Panels A and B. For Panel C, PK results were reported by dose taken and by individual period. Periods in a panel were not conducted if it became evident that exposures at the escalated dosing would not adequately reach the projected PK target. Although the plasma C12hr following a high-fat breakfast (fed state) was planned to be compared to the plasma C12hr in the fasted stated in Panel C, the fed state dose was not administered.|12 hours postdose|All participants who received study treatment and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint. Periods (P) 4 and 5 of Panel C were not conducted; the planned 120 mg fed dose (P5) was not administered.|||nmol/L||90% Confidence Interval|Geometric Least Squares Mean
2531911|NCT03326986|Secondary|MK-7252 Maximal Plasma Concentration (Cmax)|Blood samples were obtained predose (Day 1) and at designated times postdose to calculate the plasma MK-7252 Cmax reported as back-transformed least squares mean and confidence interval calculated using a linear mixed effects model performed on natural log-transformed values. PK results were reported by dose taken in Panels A and B. For Panel C, PK results were reported by dose taken and by individual period. Periods in a panel were not conducted if it became evident that exposures at the escalated dosing would not adequately reach the projected PK target. Although the plasma Cmax following a high-fat breakfast (fed state) was planned to be compared to the plasma Cmax in the fasted stated in Panel C, the fed state dose was not administered.|Predose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 10, 12, 24, 48, and 72 hours postdose|All participants who received study treatment and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint. Periods (P) 4 and 5 of Panel C were not conducted; the planned 120 mg fed dose (P5) was not administered.|||nmol/L||95% Confidence Interval|Geometric Least Squares Mean
2531912|NCT03326986|Secondary|MK-7252 Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUClast)|Blood samples were obtained predose (Day 1) and at designated times postdose to calculate the plasma MK-7252 AUClast reported as back-transformed least squares mean and confidence interval calculated using a linear mixed effects model performed on natural log-transformed values. PK results were reported by dose taken in Panels A and B. For Panel C, PK results were reported by dose taken and by individual period. Periods in a panel were not conducted if it became evident that exposures at the escalated dosing would not adequately reach the projected PK target. Although the plasma AUClast following a high-fat breakfast (fed state) was planned to be compared to the plasma AUClast in the fasted stated in Panel C, the fed state dose was not administered.|Predose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 10, 12, 24, 48, and 72 hours postdose|All participants who received study treatment and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint. Periods (P) 4 and 5 of Panel C were not conducted; the planned 120 mg fed dose (P5) was not administered.|||hr•nmol/L||95% Confidence Interval|Geometric Least Squares Mean
2531913|NCT03326986|Secondary|MK-7252 Area Under the Concentration-Time Curve From Zero to 12 Hours Postdose (AUC0-12hr)|Blood samples were obtained predose (Day 1) and at designated times postdose to calculate the plasma MK-7252 AUC0-12hr reported as back-transformed least squares mean and confidence interval calculated using a linear mixed effects model performed on natural log-transformed values. PK results were reported by dose taken in Panels A and B. For Panel C, PK results were reported by dose taken and by individual period. Periods in a panel were not conducted if it became evident that exposures at the escalated dosing would not adequately reach the projected PK target. Although the plasma AUC0-12hr following a high-fat breakfast (fed state) was planned to be compared to the plasma AUC0-12hr in the fasted stated in Panel C, the fed state dose was not administered.|Predose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 10, and 12 hours postdose|All participants who received study treatment and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint. Periods (P) 4 and 5 of Panel C were not conducted; the planned 120 mg fed dose (P5) was not administered.|||hr•nmol/L||95% Confidence Interval|Geometric Least Squares Mean
2531914|NCT03326986|Secondary|MK-7252 Area Under the Concentration-Time Curve From Zero to 24 Hours Postdose (AUC0-24hr)|Blood samples were obtained predose (Day 1) and at designated times postdose to calculate the plasma MK-7252 AUC0-24hr reported as back-transformed least squares mean and confidence interval calculated using a linear mixed effects model performed on natural log-transformed values. PK results were reported by dose taken in Panels A and B. For Panel C, PK results were reported by dose taken and by individual period. Periods in a panel were not conducted if it became evident that exposures at the escalated dosing would not adequately reach the projected PK target. Although the plasma AUC0-24hr following a high-fat breakfast (fed state) was planned to be compared to the plasma AUC0-24hr in the fasted stated in Panel C, the fed state dose was not administered.|Predose (Day 1), 0.25, 0.5, 1, 2, 4, 8, 10, 12, and 24 hours postdose|All participants who received study treatment and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint. Periods (P) 4 and 5 of Panel C were not conducted; the planned 120 mg fed dose (P5) was not administered.|||hr•nmol/L||95% Confidence Interval|Geometric Least Squares Mean
2531932|NCT03325894|Primary|Change From Baseline in Urobilinogen at Early Termination/Day 360|Change from baseline in urobilinogen were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.|Baseline, Early termination/Day 360|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||milligrams per deciliter||Standard Deviation|Mean
2532501|NCT03304873|Primary|Number of Participants With MRSA Carriage at 1 Week Post Decolonization With Retapamulin or Placebo|Study visit for nasal/peri-rectal swabs|1 Week||||Participants|||Count of Participants
2531915|NCT03326986|Secondary|MK-7252 Area Under the Concentration-Time Curve From Zero to Infinity (AUC0-∞)|Blood samples were obtained predose (Day 1) and at designated times postdose to calculate the plasma MK-7252 AUC0-∞ reported as back-transformed least squares mean and confidence interval calculated using a linear mixed effects model performed on natural log-transformed values. Pharmacokinetic (PK) results were reported by dose taken in Panels A and B. For Panel C, PK results were reported by dose taken and by individual period. Periods in a panel were not conducted if it became evident that exposures at the escalated dosing would not adequately reach the projected PK target. Although the plasma AUC0-∞ following a high-fat breakfast (fed state) was planned to be compared to the plasma AUC0-∞ in the fasted stated in Panel C, the fed state dose was not administered.|Predose (Day 1) and 0.25, 0.5, 1, 2, 4, 8, 10, 12, 24, 48, and 72 hours postdose|All participants who received study treatment and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint. Periods (P) 4-5 of Panel C were not conducted; the planned 120 mg fed dose (P 5) was not administered.|||hr•nmol/L||95% Confidence Interval|Geometric Least Squares Mean
2531916|NCT03326986|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have had a causal relationship with this treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. Discontinuations are reported by dose taken at time of event. The discontinuations for placebo are pooled over periods across panels. The number of participants who discontinued study treatment due to an AE is presented.|Up to approximately 19 weeks|All participants who received at least 1 dose of study treatment and discontinued during the study period|||Participants|||Count of Participants
2531917|NCT03326986|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have had a causal relationship with this treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. Adverse events are reported by dose taken at time of event and not by panel or period. The adverse events for placebo are pooled over periods across panels. The number of participants who experienced at least one AE is presented.|Up to approximately 21 weeks|All participants who received at least 1 dose of study treatment and experienced an AE during the study period|||Participants|||Count of Participants
2531918|NCT03326843|Secondary|Evaluate Safety of Avatrombopag: Incidence of Treatment Emergent Adverse Events|Incidence of treatment emergent adverse events|Up to 35 days|Study was early terminated due to low enrollment||||||
2531919|NCT03326843|Primary|Evaluate Efficacy of Avatrombopag in Increasing Platelet Counts in Subjects With Thrombocytopenia Scheduled for Operations|Proportion of subjects that achieve a platelet count >100 x 10^9 platelets/L on procedure day|Baseline to 10-13 days||||proportion of total participants|||Number
2531920|NCT03326323|Secondary|Recovery in Mean Clot Firmness Post ANH|Time it takes for Mean Clot Firmness (MCF) to return normal levels post-ANH as measured by ROTEM|Baseline through 24 hours post ANH procedure||||hours||Standard Deviation|Mean
2531921|NCT03326323|Primary|Recovery in Platelet Function Post ANH|Time it takes (hours) for platelet function to recover post-ANH to pre-procedure levels as measured by platelet aggregation.|Baseline through 24 hours post ANH procedure||||hours||Standard Deviation|Mean
2531922|NCT03325894|Secondary|Clinical Global Impression of Improvement (CGI-I) at Final On-Treatment Assessment (FoTA)|CGI-I scale was performed to rate the improvement of a participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date).|FoTA (up to 330 days)|FAS consisted of all participants in the safety set who have completed at least 1 post-dose efficacy assessment using ADHD-RS-5 Total Score. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Score on a scale||Standard Error|Mean
2531923|NCT03325894|Secondary|Change From Baseline in Clinician-administered Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Total Score at Final On-Treatment Assessment (FoTA)|Clinician administered ADHD-RS-5, child, home version total score were analyzed. ADHD-RS-5 consists of 18 items designed to reflect current symptomatology of ADHD based on diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) criteria. Each item is scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (9 items) and inattentiveness (9 items). Higher total scores indicated higher impairment and lower scores indicated no impairment. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date).|Baseline, FoTA (up to 330 days)|Full analysis set (FAS) consisted of all participants in the safety set who have completed at least 1 post-dose efficacy assessment using ADHD-RS-5 Total Score. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Score on a scale||Standard Error|Mean
2531924|NCT03325894|Primary|Number of Participants With a Positive Response in Columbia-Suicide Severity Rating Scale (C-SSRS) at Day 330|C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The number of participants with postive response in suicidal ideation and suicidal behavior were reported.|Day 330|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study.. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Participants|||Count of Participants
2531933|NCT03325894|Primary|Change From Baseline in Urinalysis (Specific Gravity) at Early Termination/Day 360|Change from baseline in urine specific gravity were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.|Baseline, Early termination/Day 360|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||Ratio||Standard Deviation|Mean
2531925|NCT03325894|Primary|Total Sleep Disturbance Score of Children's Sleep Habits Questionnaire (CSHQ ) at Final On-Treatment Assessment (FoTA)|"CSHQ was a tool designed to screen for the most common sleep problems in children and consisted of 33 items for scoring and several extra items intended to provide administrators with other potentially useful information about respondents. The instrument evaluates the 8 different subscales: bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night wakings, parasomnias, sleep disordered breathing, and daytime sleepiness. A 3-point scale was used for rating: usually if the sleep behavior occurs 5 to 7 times per week, sometimes for 2 to 4 times per week, and rarely for once or not at all during the week. The TSD score, which is the sum of all responses, included all items of the 8 subscales, but consisted of only 33 items because two on the bedtime resistance and sleep anxiety subscales were identical (range: 0, 99). A negative value indicates less sleep disturbance."|FoTA (up to 330 days)|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Units on scale||Standard Deviation|Mean
2531926|NCT03325894|Primary|Length of Time Sleeping Per Night Assessed by Post Sleep Questionnaire (PSQ) at Final On-Treatment Assessment (FoTA)|PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collects data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product. Length of time sleeping per night was assessed at FoTA.|FoTA (up to 330 days)|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study.|||hours||Standard Deviation|Mean
2531927|NCT03325894|Primary|Length of Time Awake Per Night and Length of Time to Fall Asleep Per Night Assessed by Post Sleep Questionnaire (PSQ) at Final On-Treatment Assessment (FoTA)|PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collects data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product. Length of time awake per night and length of time to fall asleep per night was assessed at FoTA.|FoTA (up to 330 days)|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specific categories.|||minutes||Standard Deviation|Mean
2531928|NCT03325894|Primary|Number of Participants With Quality of Sleep Assessed by Post Sleep Questionnaire (PSQ) at Final On-Treatment Assessment (FoTA)|PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collects data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. The assessment was done by the nature of the responses, not by a numbered scale. Participants analyzed for number of times woke up per night category were only the participants who responded as yes for the woke up during the night category in this outcome measure. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.|FoTA (up to 330 days)|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specific categories.|||Participants|||Count of Participants
2531929|NCT03325894|Primary|Change From Baseline in Electrocardiogram Parameters at Final On-Treatment Assessment (FoTA)|ECG was performed using the central ECG provider's equipment and was sent to the central ECG provider electronically to measure PR, RR, QRS , QT, QTcB and QTcF intervals. FoTA was defined as the last valid assessment obtained after Baseline and whilst on investigational product (on or before 2 days after the last dose date).Group A baseline was the baseline of the antecedent studies. Group B baseline was the average of all valid ECG measurements as the last assessment obtained before the first dose of investigational product.|Baseline, FoTA (up to 330 days)|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||milliseconds||Standard Deviation|Mean
2531930|NCT03325894|Primary|Change From Baseline in Heart Rate at Final On-Treatment Assessment (FoTA)|Heart rate was measured by Electrocardiogram (ECG). ECG was performed using the central ECG provider's equipment and was send to the central ECG provider electronically. Change from baseline in heart rate at FoTA were reported. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the average of all valid ECG measurements as the last assessment obtained before the first dose of investigational product.|Baseline, FoTA (up to 330 days)|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||beats per minute||Standard Deviation|Mean
2531931|NCT03325894|Primary|Change From Baseline in Urine Potential of Hydrogen (pH) at Early Termination/Day 360|Change from baseline in urine pH were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.|Baseline, Early Termination/Day 360|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||pH||Standard Deviation|Mean
2532502|NCT03304119|Secondary|Distance TT-TG Tibial Tuberosity and Trochlear Groove|distance between Tibial Tuberosity and Trochlear Groove|4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.||||milimeters||Inter-Quartile Range|Median
2531934|NCT03325894|Primary|Change From Baseline in Thyroxine,Free at Early Termination/Day 360|Change from baseline in thyroxine,free were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.|Baseline, Early termination/Day 360|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||picomole per liter||Standard Deviation|Mean
2531935|NCT03325894|Primary|Change From Baseline in Thyrotropin at Early Termination/ Day 360|Change from baseline in thyrotropin were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.|Baseline, Early termination/Day 360|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||milli-international units per litre||Standard Deviation|Mean
2531936|NCT03325894|Primary|Change From Baseline in Chemistry Parameters (Bilirubin and Creatinine) at Early Termination/Day 360|Change from baseline in chemistry parameters bilirubin and creatinine were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.|Baseline, Early termination/Day 360|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specific categories.|||micromoles per liter||Standard Deviation|Mean
2531937|NCT03325894|Primary|Change From Baseline in Chemistry Parameters (Blood Urea Nitrogen, Cholesterol, Glucose, Phosphate, Potassium, Sodium and Urate) at Early Termination/Day 360|Change from baseline in chemistry parameters blood urea nitrogen, cholesterol, glucose, phosphate, potassium, sodium and urate were studies. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.|Baseline, Early termination/Day 360|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specific categories.|||millimoles per liter||Standard Deviation|Mean
2531938|NCT03325894|Primary|Change From Baseline in Chemistry Parameters (Albumin and Protein) at Early Termination/Day 360|Change from baseline in chemistry parameters albumin and protein were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.|Baseline, Early termination/Day 360|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||gram per liter||Standard Deviation|Mean
2531939|NCT03325894|Primary|Change From Baseline in Chemistry Parameters at Early Termination/Day 360|Change from baseline in chemistry parameter alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, and lactate dehydrogenase were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.|Baseline, Early termination/Day 360|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specific categories|||Unit per liter||Standard Deviation|Mean
2531940|NCT03325894|Primary|Change From Baseline in Hematology Parameters (Erythrocytes Mean Corpuscular Volume and Mean Platelet Volume) at Early Termination/ Day 360|Change from baseline in hematology parameter erythrocytes mean corpuscular volume and mean platelet volume were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.|Baseline, Early termination/Day 360|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specific categories.|||femtoliters||Standard Deviation|Mean
2531941|NCT03325894|Primary|Change From Baseline in Hemoglobin at Early Termination/Day 360|Change from baseline in hematology parameter hemoglobin were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.|Baseline, Early termination/Day 360|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||gram per liter||Standard Deviation|Mean
2531942|NCT03325894|Primary|Change From Baseline in Hematocrit at Early Termination/Day 360|Change from baseline in hematology parameter hematocrit were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.|Baseline, Early termination/Day 360|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||percentage of hematocrit||Standard Deviation|Mean
2531943|NCT03325894|Primary|Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin at Early Termination/Day 360|Change from baseline in hematology parameter erythrocytes mean corpuscular hemoglobin were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.|Baseline, Early termination/Day 360|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||picogram||Standard Deviation|Mean
2531973|NCT03323723|Secondary|Adverse Events and Labs Evaluation to Determine Safety of the Device|Evaluation and analysis of AEs to determine safety as recommended in FDA SUI Clinical Trial Guidance - The safety of the OTC SUI pessary device will be evaluated by assessing all adverse events, including the results of urinalysis, vaginal swab, and vaginal examination.|21 days|Safety population|||events|||Number
2539017|NCT03086265|Secondary|Time to Spontaneous Ventilation|Recorded from the discontinuation of anesthetic drugs to the return of patient's spontaneous ventilation.|Duration of surgery (average approximately 1 hour)||||minutes||Standard Deviation|Mean
2531944|NCT03325894|Primary|Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin Concentration at Early Termination/Day 360|Change from baseline in hematology parameter erythrocytes mean corpuscular hemoglobin concentration were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.|Baseline, Early termination/Day 360|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study.Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||gram per deciliter||Standard Deviation|Mean
2531945|NCT03325894|Primary|Change From Baseline in Erythrocytes at Early Termination/Day 360|Change from baseline in hematology parameter erythrocytes were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.|Baseline, Early termination/Day 360|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||10^12 cells per liter||Standard Deviation|Mean
2531946|NCT03325894|Primary|Change From Baseline in Leukocytes at Early Termination/Day 360|Change from baseline in hematology leukocytes parameter: basophils, eosinophils, lymphocytes, monocytes and neutrophil were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.|Baseline, Early termination/Day 360|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specific categories.|||percentage of leukocytes||Standard Deviation|Mean
2531947|NCT03325894|Primary|Change From Baseline in Hematology Parameters at Early Termination/Day 360|Change from baseline in hematology parameter basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils band form, segmented neutrophils, neutrophils/total cells and platelets were reported. Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product.|Baseline, Early termination/Day 360|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specific categories.|||10^9 cells per liter||Standard Deviation|Mean
2531948|NCT03325894|Primary|Change From Baseline in Weight at Final On-Treatment Assessment (FoTA)|Weight was measured in kilograms (kg) without shoes and with light clothing using a calibrated scale. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.|Baseline, FoTA (up to 330 days)|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study.|||kilograms||Standard Deviation|Mean
2531949|NCT03325894|Primary|Change From Baseline in Height at Final On-Treatment Assessment (FoTA)|Height was measured in centimeters (cm) without shoes and with light clothing using a stadiometer. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.|Baseline, FoTA (up to 330 days)|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study.|||centimeter||Standard Deviation|Mean
2531950|NCT03325894|Primary|Change From Baseline in Blood Pressure at Final On-Treatment Assessment (FoTA)|Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at FoTA was reported. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.|Baseline, FoTA (up to 330 days)|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study.|||Millimeters of mercury||Standard Deviation|Mean
2531951|NCT03325894|Primary|Change From Baseline in Pulse Rate at Final On-Treatment Assessment (FoTA)|Change from baseline in pulse rate at FoTA was reported. FoTA was defined as the last valid assessment obtained after baseline and whilst on investigational product (on or before 2 days after the last dose date). Group A baseline was the baseline of the antecedent studies. Group B baseline was the last value collected before the first dose of investigational product in the current study.|Baseline, FoTA (up to 330 days)|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study.|||beats per minute||Standard Deviation|Mean
2531952|NCT03325894|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs was defined as AEs that start or deteriorate on or after the date of the first dose of investigational product and no later than 3 days following the last dose of investigational product.|From start of study drug administration up to follow-up (approximately up to 367 days)|Safety set consisted of all participants who had taken at least 1 dose of investigational product in this current study.|||Participants|||Count of Participants
2531953|NCT03325881|Secondary|Number of Participants With a Positive Response in Columbia-suicide Severity Rating Scale (C-SSRS) at Week 4|C-SSRS was a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The number of participants with clinical significant change in suicidal ideation and suicidal behavior were reported.|Week 4|Safety set consisted of all participants in the randomized set who took at least 1 dose of investigational product. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Participants|||Count of Participants
2531986|NCT03323086|Primary|Feasibility of Providing Intervention|percentage of individuals who attended their intervention|Immediately following intervention session (post-intervention), up to 30 minutes|50 patients enrolled. 2 patients withdrew prior to randomization. Leaving 48 participants for this analysis.|||Participants|||Count of Participants
2531954|NCT03325881|Secondary|Total Sleep Disturbance Score of Children's Sleep Habits Questionnaire (CSHQ ) at Week 4|"The CSHQ is a validated, retrospective, parent-reported sleep screening tool. The questionnaire consists of 35 items that yield a TSD score, as well as 8 subscale scores, including bedtime resistance, sleep duration, parasomnias, sleep disordered breathing, night wakings, daytime sleepiness, sleep anxiety, and sleep onset delay. Parents were asked to think of a recent typical week of their child's sleep and to indicate how often sleep disturbance behaviors occurred. A 3-point scale was used for rating: usually if the sleep behavior occurs 5 to 7 times per week, sometimes for 2 to 4 times per week, and rarely for once or not at all during the week. The TSD score, which is the sum of all responses, included all items of the 8 subscales, but consisted of only 33 items because two on the bedtime resistance and sleep anxiety subscales were identical (range: 0, 99). A negative value indicates less sleep disturbance."|Week 4|Safety set consisted of all participants in the randomized set who took at least 1 dose of SHP465. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Units on scale||Standard Deviation|Mean
2531955|NCT03325881|Secondary|Change From Baseline in Length of Time Sleeping Per Night Assessed by PSQ at Week 4|The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week.|Baseline, Week 4|Safety set consisted of all participants in the randomized set who taken at least 1 dose of investigational product. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||hours||Standard Deviation|Mean
2531956|NCT03325881|Secondary|Change From Baseline in Length of Time Awake Per Night and Length of Time to Fall Asleep Per Night Assessed by PSQ at Week 4|The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week.|Baseline, Week 4|Safety set consisted of all participants in the randomized set who taken at least 1 dose of investigational product. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||minutes||Standard Deviation|Mean
2531957|NCT03325881|Secondary|Number of Participants With Quality of Sleep Assessed by Post Sleep Questionnaire (PSQ) at Baseline and Week 4|The PSQ was a 7-item questionnaire typically used to assess sleep quality with pharmacologic treatment. The questionnaire collected data on average time to sleep, sleep latency, frequency of interrupted sleep, duration of interrupted sleep, total sleep time and sleep quality over the last week. Participants analyzed for number of times woke up per night category were only the participants who responded as yes for the woke up during the night category in this outcome measure.|Baseline, Week 4|Safety set consisted of all participants in the randomized set who taken at least 1 dose of investigational product. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Participants|||Count of Participants
2531958|NCT03325881|Secondary|Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Assessed by the Investigator|Participants with clinically significant deviations from baseline values which are deemed clinically significant in the opinion of the investigator were considered in 12-lead ECG and reported.|From start of study drug administration up to follow-up (Week 5)|Safety set consisted of all participants in the randomized set who taken at least 1 dose of investigational product.|||Participants|||Count of Participants
2531959|NCT03325881|Secondary|Number of Participants With Clinically Significant Change in Clinical Laboratory Test Results Assessed by the Investigator|Clinical laboratory tests included biochemistry, endocrinology, hematology and urinalysis. The investigator assessed out-of-range clinical laboratory values for clinical significance, if the value(s) were not clinically significant or clinically significant.|From start of study drug administration up to follow-up (Week 5)|Safety set consisted of all participants in the randomized set who taken at least 1 dose of investigational product.|||Participants|||Count of Participants
2531960|NCT03325881|Secondary|Number of Participants With Clinically Significant Change in Vital Signs Were Reported as Adverse Event (AE)|Vital sign assessments included systolic and diastolic blood pressure and pulse. Participants with clinically significant deviations from baseline values which are deemed clinically significant in the opinion of the investigator were considered as AE's. An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.|From start of study drug administration up to follow-up (Week 5)|Safety set consisted of all participants in the randomized set who taken at least 1 dose of investigational product.|||Participants|||Count of Participants
2531961|NCT03325881|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs that start or deteriorate on or after the date of the first dose of investigational product and no later than 3 days following the last dose of investigational product.|From start of study drug administration up to follow-up (Week 5)|Safety set consisted of all participants in the randomized set who as taken at least 1 dose of investigator product.|||Participants|||Count of Participants
2531962|NCT03325881|Secondary|Clinical Global Impression of Improvement (CGI-I) at Week 4|CGI scale was measured to rate the overall improvement of a participants condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). LS mean was calculated based on restricted maximum likelihood (REML) method of estimation and utilized an unstructured covariance type.|Week 4|Full analysis set consisted of all participants in the safety set who had baseline ADHD-RS-5 total score and at least 1 postdose ADHD-RS-5 total score. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2531987|NCT03322930|Primary|Rod Sensitivity Within the Central Retina as Measured on the Nidek MP-3S|Number of participants with rod sensitivity measured in decibels at multiple retinal locations within the central retina|through study completion, an average of 1 year||||Participants|||Count of Participants
2540875|NCT03039569|Secondary|Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years|Self report survey question|Three months|Chi-square|||Participants|||Count of Participants
2531963|NCT03325881|Primary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale-5 (ADHD-RS-5) Total Score at Week 4|Clinician administered ADHD-RS-5, child, home version total score were analyzed. ADHD-RS-5 consisted of 18 items designed to reflect current symptomatology of ADHD based on diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity or impulsivity (9 items) and inattentiveness (9 items). Higher total scores indicated higher impairment and lower scores indicated no impairment. Least square (LS) mean was calculated based on restricted maximum likelihood (REML) method of estimation and utilized an unstructured covariance type.|Baseline, Week 4|Full analysis set consisted of all participants in the safety set who had baseline ADHD-RS-5 total score and at least 1 postdose ADHD-RS-5 total score. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2531964|NCT03325673|Primary|Total Wear Time (Total WT) in the Study Eye|Total WT was calculated by taking the difference between the time participants reported removing their CLs and the reported insertion time for that day. The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.|Day 24|All eligible participants with data available for analysis at the given time-point.|||minutes||Standard Deviation|Mean
2531965|NCT03325673|Primary|Comfortable Wear Time (CWT) in the Study Eye|CWT was calculated by taking the difference between the time participants reported started to find their CLs getting uncomfortable and the reported insertion time for that day. The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.|Day 24|All eligible participants with data available for analysis at the given time-point.|||minutes||Standard Deviation|Mean
2531966|NCT03325673|Primary|Comfort Rating Score in the Study Eye|The participant assessed contact lens comfort in the study eye using a 100 point scale where a score of 0=Extremely uncomfortable and a score of 100=Extremely comfortable. The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.|CL Insertion, After 2 hours and the End of Day on Day 24|All eligible participants with data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
2531967|NCT03325673|Primary|Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score in the Study Eye|The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst). The study eye was defined as the qualified eye with the greatest increase in tear production with stimulation by a cotton swab at the Screening Visit. If both eyes qualified, then the right eye was designated as the study eye.|Day 28|All eligible participants with data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
2531968|NCT03323736|Secondary|Anesthesia Effectiveness|"Count (percentage) of subjects in the pivotal cohort, who completed iontophoresis for all indicated ears, with adequate anesthesia for TT placement in all treated ears as determined by physician's evaluation of TM anesthesia prior to tube placement.~Note- the secondary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts."|Day of Procedure (Day 0)||||Participants|||Count of Participants
2531969|NCT03323736|Secondary|Tube Retention|"Count (percentage) of subjects in the pivotal cohort, in which a Tusker Medical tube(s) was successfully placed, with presence of a Tusker Medical tube across the TM in all successfully treated ears at the 3-week post-procedure follow-up visit.~Note- the secondary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.~Note - This endpoint includes subjects for which at least 1 ear had successful tube placement. For bilateral subjects, they may be considered a non-successful procedure if only 1 ear had successful tube placement, however would be evaluated for the Tube Retention endpoint for the ear that was successful."|3 Weeks Post Procedure||||Participants|||Count of Participants
2531970|NCT03323736|Secondary|Tube Patency|"Count (and percentage) of subjects in the pivotal cohort, in which a Tusker Medical tube was successfully placed, with functionally patent tube(s) at the 3-week post-procedure follow-up visit.~Note- thus secondary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.~Note - This endpoint includes subjects for which at least 1 ear had successful tube placement. For bilateral subjects, they may be considered a non-successful procedure if only 1 ear had successful tube placement, however would be evaluated for the Tube Patency endpoint for the ear that was successful."|3 Weeks Post Procedure||||Participants|||Count of Participants
2531971|NCT03323736|Primary|Tube Placement Tolerability|Mean subject-reported pain score following TDS tube placement using the Faces Pain Scale-Revised (FPS-R) (pivotal cohort children ages 5 and older only). The FPS-R has 6 faces which permits scaling to a 0-to-10 scoring system in intervals of 2 (ie 0, 2, 4, 6, 8 and 10), where 0 represents 'no pain' and 10 represents 'very much pain'. Note- the primary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.|Day of Procedure (Day 0) Immediately following tube placement|Subjects with successful tube placement only. Note - 2 subjects were excluded from analysis because they did not self-report their pain scores, resulting in 89 participants analyzed.|||score on a scale||Standard Deviation|Mean
2531972|NCT03323736|Primary|Procedural Success:|Count (and percentage) of subjects in the pivotal cohort with successful placement of Tusker Medical tympanostomy tubes in all indicated ears in an office procedure. Note: the primary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.|Day of Procedure (Day 0) Immediately following tube placement||||Participants|||Count of Participants
2533615|NCT03263806|Secondary|Incidence of Major Adverse Cardiac Events|Incidence of any serious adverse event, defined as death, acute coronary syndrome or late unscheduled revascularization|1 year after presentation|Study terminated with NO data collected.||||||
2531974|NCT03323723|Secondary|Change in Quality of Life From Before Treatment Phase to After Treatment Phase|Change in Quality of Life as measured by the ICIQ-LUTSqol - The Quality of Life Questionnaire to be performed at baseline, before, and after treatment phase of the study is based on 20 questions referring to areas which may have been influenced or changed by accidental urine loss and/or prolapse. These questions are assigned a value of, 1 = 'Not at all,' 2= 'Slightly,' 3 = 'Moderately,' or 4 'A lot.' Each area is then assessed on a scale of 1-10 to see how much it bothers them. The Questionnaire is scored by taking the average score of items and then multiplying that value by 25 to put scores on a scale from 0 to 100. A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction in scores at the end of the Treatment Phase from post-baseline/before Treatment Phase, reflects improved quality of life. A reduction in score of > 3.7 is considered the Minimum Clinically Important Difference (MCID).|Before Treatment Phase and After Treatment Phase is complete|mITT population|||Change in QoL score||95% Confidence Interval|Mean
2531975|NCT03323723|Secondary|Change in Mean SUI Episodes During Treatment Phase as Compared to Baseline Phase|Change in mean number of SUI episodes per day from the 7-day baseline period to the last 7 days of the 14-day device treatment period. Participants will record SUI episodes in the Study Diary during the baseline (7 days) and treatment (14 days) periods. Negative values are indicative of efficacious outcome. Each subject will have a change in the number of episodes per day from the control period to the treatment period. Specifically, the number of episodes will be recorded each day in the diary. For the control phase, there will be (at most) 7 days of data. The mean number of SUI episodes per day will be computed for each subject. The same measures will occur in the treatment period for the analysis period, the last 7 days.|7 days of baseline period and last 7 days of treatment phase|mITT population|||number of episodes||95% Confidence Interval|Mean
2531976|NCT03323723|Primary|Percentage Reduction of Mean Pad Weight Gain (g/hr) During Treatment Phase as Compared to Baseline Phase.|Pad weight gain (PWG) was measured by weighing used pads returned by participants and subtracting the pre-weight of that pad to obtain the total weight of leakage. The total weight of leakage was then divided by the number of hours the pad was worn by the participant to calculate the PWG/hr. The average PWG/hr for baseline was calculated by averaging the PWG/hr for the entire 7 days of the baseline phase. The average treatment PWG/hr for treatment phase was calculated by averaging the PWG/hr of the last 7 days of treatment phase. The percent change from baseline to treatment phase was then calculated. The objective was to show that PWG/hr is reduced by >50% during treatment phase. Thus, the null hypothesis is that the mean weight gain reduction per hour is <=50%, and the alternative is that it is >50%, from the control period (no device) to the treatment period (women wearing the device).|7 days of the baseline phase and 7 days of treatment phase|mITT Population|||percent change||98.33% Confidence Interval|Mean
2531977|NCT03323307|Post-Hoc|Contrast-to-Noise Ratio (CNR)|Measure of OCT image quality comparing level of image contrast to level of background noise. CNR = (mean of signal of region of interest [i.e., retina] - mean of background noise) divided by square root of (the square of the standard deviation of the region of interest + the square of the standard deviation of the background noise). Therefore, CNR is unitless.|day 1|Participants from whom OCT images of acceptable quality were obtained.|||unitless||Standard Deviation|Mean
2531978|NCT03323307|Secondary|Total Macular Volume|compare total macular volume measurements obtained with low cost OCT system and Heidelberg Spectralis OCT system|day 1|Volumetric imaging was not achievable with the current version of the low cost OCT device due to the line rate being too slow. Volumetric imaging was possible on the Heidelberg Spectralis OCT, but at a significant increase in acquisition time, which was not feasible for amount of time we had with each subject.||||||
2531979|NCT03323307|Secondary|Central Macular Thickness|compare measurements of central macular thickness obtained with low cost OCT system and Heidelberg Spectralis OCT system|day 1|The current version of the low cost OCT device only acquired a single line image on the retina per scan, which did not allow for the pinpointing of the central macula. Therefore, central macular thickness could not be measured.||||||
2531980|NCT03323307|Primary|Number of Participants With Acceptable OCT Image Quality|measured by: ability to see clearly defined and recognizable structures of the retina with the low cost OCT device|day 1||||Participants|||Count of Participants
2531981|NCT03323086|Secondary|Alcohol Use Binge Frequency|The number of drinking occasions (single day) when 4 or more drinks are consumed|3-month Follow-up|50 patients enrolled. However, 2 patients withdrew prior to randomization, 2 withdrew post-randomization, and 3 were lost to follow-up, leaving a total of 43 patients who provided data at this 3-month follow-up assessment.|||heavy episodic drinking days||Standard Deviation|Mean
2531982|NCT03323086|Secondary|Alcohol Use Quantity|The average number of drinks in a week|3-month Follow-up|50 patients enrolled. However, 2 patients withdrew prior to randomization, 2 withdrew post-randomization, and 3 were lost to follow-up, leaving a total of 43 patients who provided data at this 3-month follow-up assessment.|||drinks per week||Standard Deviation|Mean
2531983|NCT03323086|Secondary|Condomless Sex|The number of occasions of condomless sex|3-month Follow-up|50 patients enrolled. However, 2 patients withdrew prior to randomization, 2 withdrew post-randomization, and 3 were lost to follow-up, leaving a total of 43 patients who provided data at this 3-month follow-up assessment.|||events of condomless sex||99% Confidence Interval|Median
2531984|NCT03323086|Secondary|Number of Sexual Partners|The number of male partners that the participant reported having penetrative sex with.|3-month Follow-up|50 patients enrolled. However, 2 patients withdrew prior to randomization, 2 withdrew post-randomization, and 3 were lost to follow-up, leaving a total of 43 patients who provided data at this 3-month follow-up assessment.|||partners||Standard Deviation|Mean
2531985|NCT03323086|Secondary|Session Evaluation Questionnaire|Measure Name: Session Evaluation Questionnaire; Construct Assessed: Treatment Satisfaction; Minimum total scale score = 1; Maximum total scale score = 5; Scoring: averaged ratings across 4 items; Interpretation: Higher scores represent a better outcome.|Immediately following intervention session (post-intervention), up to 30 minutes|50 patients enrolled. However, 2 patients withdrew prior to randomization and 2 withdrew post-randomization leaving a total of 46 patients who provided data at this post-intervention assessment.|||units on a scale||Standard Deviation|Mean
2532599|NCT03300024|Secondary|Percentage of Patients With Surgical Site Infection|The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.|At 18 months after Graft Placement|Data was not collected for this outcome measure||||||
2531988|NCT03322566|Secondary|Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Discontinuing Study Drug Due to AEs|An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.|Assessed from the fist dose until the Data Cut Off of 13-Dec 18.|All Subjects as Treated consists of all randomized participants who received at least one dose of study treatment. This was no longer a secondary outcome for arm pembrolizumab+epacadostat as the study was amended prospectively from a phase 3 to phase 2 with different objectives as per amendment 5; this study arm was dropped.|||Participants|||Count of Participants
2531989|NCT03322566|Secondary|Safety and Tolerability of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo as Measured by the Number of Participants Experiencing Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.|Assessed from the fist dose until the Data Cut Off of 13-Dec 18.|All Subjects as Treated consists of all randomized participants who received at least one dose of study treatment. This was no longer a secondary outcome for arm pembrolizumab+epacadostat as the study was amended prospectively from a phase 3 to phase 2 with different objectives as per amendment 5; this study arm was dropped.|||Participants|||Count of Participants
2531990|NCT03322566|Secondary|Duration of Response of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo|Defined as the time from the earliest date of qualifying response until earliest date of disease progression, per RECIST v1.1, or death from any cause, whichever comes first.|Assessed from the fist dose until the Data Cut Off of 13-Dec 18.|ITT population consisted of all participants randomized in arms Pembrolizumab+Epacadostat+Chemotherapy and Pembrolizumab+Chemothrapy. This was no longer a secondary outcome for arm pembrolizumab+epacadostat as the study was amended prospectively from a phase 3 to phase 2 with different objectives as per amendment 5; this study arm was dropped.|||months||95% Confidence Interval|Median
2531991|NCT03322566|Secondary|Overall Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo|Defined as the time from randomization to death due to any cause.|Assessed from the start of study until the Data Cut Off of 13-Dec 18.|ITT population consisted of all participants randomized in arms Pembrolizumab+Epacadostat+Chemotherapy and Pembrolizumab+Chemothrapy. This was no longer a secondary outcome for arm pembrolizumab+epacadostat as the study was amended prospectively from a phase 3 to phase 2 with different objectives as per amendment 5; this study arm was dropped.|||months||95% Confidence Interval|Median
2531992|NCT03322566|Secondary|Progression-free Survival of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo|Defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first.|Assessed from the start of the study until death or PD, whichever was earlier until the Data Cut Off of 13-Dec 18.|ITT population consisted of all participants randomized in arms Pembrolizumab+Epacadostat+Chemotherapy and Pembrolizumab+Chemothrapy. This was no longer a secondary outcome for arm pembrolizumab+epacadostat as the study was amended prospectively from a phase 3 to phase 2 with different objectives as per amendment 5; this study arm was dropped.|||months||95% Confidence Interval|Median
2531993|NCT03322566|Primary|Objective Response Rate (ORR) of Pembrolizumab + Chemotherapy + Epacadostat Versus Pembrolizumab + Chemotherapy + Placebo|ORR is defined as the percentage of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) based on blinded independent central review (BICR).|Assessed after a minimum of 12 weeks of follow-up ( Data Cut Off of 13-Dec 18).|ITT population consisted of all participants randomized in arms Pembrolizumab+Epacadostat+Chemotherapy and Pembrolizumab+Chemothrapy. This was no longer a primary outcome for arm pembrolizumab+epacadostat as the study was amended prospectively from a phase 3 to phase 2 study with different objectives as per amendment 5; this study arm was dropped.|||percentage of participants||95% Confidence Interval|Number
2531994|NCT03322540|Secondary|Number of Participants Who Discontinued Study Drug Due to AEs|AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.|Up to 37 months|||||||
2531995|NCT03322540|Secondary|Number of Participants With Adverse Events (AEs)|AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.|Up to 37 months|||||||
2531996|NCT03322540|Secondary|Duration of Response (DOR) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo|DOR is defined as the time from the earliest date of qualifying response until earliest date of disease progression per RECIST v1.1 or death from any cause, whichever comes first.|Up to approximately 36 months|||||||
2531997|NCT03322540|Secondary|Overall Survival (OS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo|OS is defined as the time from randomization to death due to any cause.|Up to approximately 36 months|||||||
2531998|NCT03322540|Secondary|Progression-free Survival (PFS) of Pembrolizumab + Epacadostat Versus Pembrolizumab + Placebo|PFS is defined as the time from randomization to the first documented progressive disease per RECIST v1.1 based on BICR or death due to any cause, whichever occurs first.|Up to approximately 36 months|||||||
2531999|NCT03322540|Primary|Objective Response Rate (ORR) of Pembrolizumab Plus Epacadostat Versus Pembrolizumab Plus Placebo|ORR is defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 based on blinded independent central review (BICR).|Up to approximately 6 months|ITT population consisted of all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2532000|NCT03322514|Secondary|Insulin Level in Serum||Baseline, 12 weeks||||mU/mL||Standard Error|Mean
2532001|NCT03322514|Secondary|Glucose Blood Level Baseline to 12 Weeks||Baseline, 12 weeks||||mmol/L||Standard Error|Mean
2532002|NCT03322514|Primary|Change in Weight Loss Compared to Baseline|The weight assessed by a body scale|Baseline and 12 weeks||||kg||Standard Error|Mean
2540971|NCT03037541|Secondary|Number of Participants With 75% Clearance|The secondary endpoint is number of participants that receive 75 % clearance of|24 weeks||||Participants|||Count of Participants
2532003|NCT03322423|Secondary|Overall Quality of Vision|Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|1-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Units on a scale||Standard Deviation|Mean
2532004|NCT03322423|Primary|Near Binocular Visual Acuity|Near visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using reduced Guillon-Poling Charts.|1-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||logMAR|Eyes|Standard Deviation|Mean
2532005|NCT03322423|Primary|Distance Binocular Visual Acuity|Distance visual acuity was assessed for each subject in both eyes under a high luminance high contrast condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts.|1-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||logMAR|Eyes|Standard Deviation|Mean
2532006|NCT03322293|Secondary|Peak Pain Score at Day 8 Post-treatment|Pain was measured by patient report with a visual analog scale from 0-10. 0 indicates no pain and 10 indicates the maximum pain score.|8 days post-treatment|24 participants who underwent treatment were analyzed, with data from the 1 participant from Group C who was lost to follow up carried forward. 8 participants from each subgroup were analyzed, with 24 participants overall. Mean peak pain on day 8 with a 95% confidence interval for each treatment group on day 8 is reported below.|||score on a scale||95% Confidence Interval|Mean
2532007|NCT03322293|Secondary|Change in Local Skin Reaction From Pre-treatment to 12 Weeks Post-treatment|To determine whether daylight PDT affords a reduction in local skin reaction to treatment. A Local Skin Response Assessment scale will be used to measure this outcome. The investigators will grade categories including Erythema, Flaking/Scaling, crusting, swelling, Pustulation (pustules), and Erosion, on a 0-4 scale (total maximum score of 24). A higher score indicates more erythema, flaking, crusting, etc. and therefore a more robust skin reaction. A score of 0 represents no erythema, flaking, crusting, etc.|12 weeks|24 participants who underwent treatment were analyzed, with data from the 1 participant lost to follow up in Group C carried forward. 8 participants were analyzed for each subgroup, with 24 participants analyzed overall.|||score on a scale||95% Confidence Interval|Mean
2532008|NCT03322293|Secondary|Reduction of AK Counts|The number of AK lesions within the treatment area was assessed both pre and post-treatment. Then, the number of participants with various levels of AK lesion reduction (100% reduction or greater than 75% reduction) was calculated for each treatment group. This outcome measures the proportion of subjects with complete (100%) and partial (greater than or equal to 75%) reduction of baseline actinic keratosis lesion counts at 12 weeks (study end).|12 weeks|24 participants who underwent treatment were analyzed, with data from the 1 participant in group C who was lost to follow up carried forward. 8 Participants were included in data analysis for each subgroup, with 24 participants included overall.|||Participants|||Count of Participants
2532009|NCT03322293|Secondary|Percent Change in AK Lesion Count|The number of actinic keratoses within the treatment area was counted both pre and post-treatment. Then, the mean percent change from baseline actinic keratosis lesion count was calculated for each treatment group.|12 weeks|24 participants who underwent treatment were analyzed, with the data for the 1 participant in group C who was lost-to-follow up carried forward. This means that data for 8 participants in each subgroup and 24 participants overall was analyzed for this outcome.|||percent change||Standard Deviation|Mean
2532010|NCT03322293|Primary|Change in Treatment Symptoms|Primary objective is to determine whether daylight PDT changes treatment symptoms of pain, stinging/burning, and itching/pruritus. This was measured using a visual analog scale from 0-10, with higher scores indicating worse treatment symptoms, or more pain/burning/itching. Lower scores indicate less pain, burning/stinging, and itching/pruritus. Positive numbers represent increases in symptoms and negative numbers represent decreases.|12 weeks|24 participants enrolled in the study who underwent treatment were analyzed.|||score on a scale||95% Confidence Interval|Mean
2532011|NCT03321396|Secondary|Number of Patients With Late Tissue Injury|To keep follow up the patient's clinical symptoms to evaluate the delayed of bleeding/perforation after one month of hydrogel injection.|One month after endoscopy||||Participants|||Count of Participants
2532012|NCT03321396|Secondary|Number of Patients With Delayed Bleeding/Perforation|Perform the endoscopy to evaluate the delayed of bleeding/perforation after 4 weeks of hydrogel injection.|An average of 4 weeks||||Participants|||Count of Participants
2532013|NCT03321396|Primary|Number of Patients With Postpolypectomy Electrocoagulation Syndrome|To evaluate patient's clinical symptoms and patient's complaints about the post-polypectomy electrocoagulation syndrome. The post-polypectomy electrocoagulation syndrome occurs after performing the endoscopy, and its signs and symptoms are similar to the signs and symptoms of perforation, such as severe abdominal pain and fever.|5 days after resection||||Participants|||Count of Participants
2532014|NCT03321253|Secondary|Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months||2 Months||||micrometer||Standard Deviation|Mean
2532015|NCT03321253|Primary|Changes of Iridocorneal Angle From Baseline at 2 Months|Iridocorneal angle was measured by using anterior segment module optical coherence tomography and recorded as millimeter before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and 2-month|2 months||||degree||Standard Deviation|Mean
2532016|NCT03321253|Primary|Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months|Anterior chamber depth was measured by using anterior segment module optical coherence tomography and recorded as millimeter before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and at 2-month|2 months||||millimeter||Standard Deviation|Mean
2532017|NCT03321253|Primary|Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months|Subfoveal, temporal and nasal choroidal thicknesses were measured by using enhanced-deep imaging optical coherence tomography and recorded as micrometer before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and at 2-month|2 months||||micrometer||Standard Deviation|Mean
2534208|NCT03247673|Primary|AUC0-inf|Area under the concentration-time curve from time zero to infinity|pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI|PK population|||h*ug/mL||Standard Deviation|Mean
2532020|NCT03320941|Secondary|Percent Change From Baseline on Subcutaneous Fat Area (SFA) at Week 12|SFA by CT scan will be measured at visits and evaluated centrally. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12|Baseline, Week 12|Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126|||Percentage||95% Confidence Interval|Mean
2532021|NCT03320941|Secondary|Percent Change From Baseline on Visceral Fat Area (VFA) at Week 12|VFA by CT scan will be measured at visits and evaluated centrally. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12|Baseline, Week 12|Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126|||Percent||95% Confidence Interval|Mean
2532022|NCT03320941|Secondary|Change From Baseline on Urine Albumin to Creatinine Ratio at Week 12|Urine albumin to creatinine ratio will be measured from urine sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12|Baseline, Week 12|Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126|||mg/mmol||95% Confidence Interval|Mean
2532023|NCT03320941|Secondary|Change From Baseline on Urine Albumin at Week 12|Urine albumin will be measured from urine sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12|Baseline, Week 12|Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126|||x 10^4 mmol/L||95% Confidence Interval|Mean
2532024|NCT03320941|Secondary|Change From Baseline in Uric Acid at Week 12|Uric acid will be measured from a blood sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12|Baseline, Week 12|Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126|||μmol/L||95% Confidence Interval|Mean
2532025|NCT03320941|Secondary|Percent Change From Baseline at Week 12 on High Sensitive C-reactive Protein (hsCRP)|High sensitivity CRP will be measured from a blood sample and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12|Baseline, Week 12|Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126|||Percentage||95% Confidence Interval|Mean
2532026|NCT03320941|Secondary|Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Low Density Lipoprotein (LDL)|Fasting lipid profile (LDL), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12|Baseline, Week 12|Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126|||Percentage||95% Confidence Interval|Mean
2532027|NCT03320941|Secondary|Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - High Density Lipoprotein (HDL)|Fasting lipid profile (HDL), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12|Baseline, Week 12|Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126|||Percentage||95% Confidence Interval|Mean
2532028|NCT03320941|Secondary|Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Total Cholesterol|Fasting lipid profile (total cholesterol), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12|Baseline, Week 12|Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126|||Percentage||95% Confidence Interval|Mean
2532029|NCT03320941|Secondary|Percentage Change From Baseline at Week 12 on Fasting Lipid Profile - Triglycerides (TG)|Fasting lipid profile (Triglycerides (TG)), will be measured on blood samples obtained after an overnight fast and analyzed at a central laboratory For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12|Baseline, Week 12|Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126|||Percentage||95% Confidence Interval|Mean
2532030|NCT03320941|Secondary|Change From Baseline at Week 12 on Diastolic Blood Pressure (DBP)|After the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, DBP will be measured three times using the automatic BP monitor and an appropriate size cuff. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12|Baseline, Week 12|Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126|||mmHg||95% Confidence Interval|Mean
2532031|NCT03320941|Secondary|Change From Baseline at Week 12 on Systolic Blood Pressure (SBP)|After the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, SBP will be measured three times using the automatic BP monitor and an appropriate size cuff. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12|Baseline, Week 12|Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126|||mmHg||95% Confidence Interval|Mean
2554595|NCT02756689|Secondary|Total Duration of Time of Neuraxial Anesthesia Use||Assessed from baseline to delivery, up to 3 days||||hours||Standard Deviation|Mean
2532032|NCT03320941|Secondary|Change From Baseline at Week 12 on Fasting Plasma Glucose (FPG)|FPG will be measured from a blood sample obtained after an overnight fast (at least 8h after last evening food intake) at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12|Baseline, Week 12|Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126|||mmol/L||95% Confidence Interval|Mean
2532033|NCT03320941|Secondary|Percentage Change From Baseline at Week 12 on Hemoglobin A1c (HbA1c)|HbA1c will be measured from a blood sample obtained and analyzed at a central laboratory. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12|Baseline, Week 12|Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126|||Percentage||95% Confidence Interval|Mean
2532034|NCT03320941|Secondary|Change From Baseline at Week 12 on Waist Circumference at Umbilical Level|Waist circumference will be measured to the nearest 0.1 cm in a standing position, at the end of a normal expiration, using a tape at the level of umbilicus. For the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12|Baseline, Week 12|Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126|||cm||95% Confidence Interval|Mean
2532035|NCT03320941|Secondary|Percentage Change From Baseline in Body Weight at Week 12 in Dysglycemic Participants and Participants With Type 2 Diabetes Mellitus (T2DM)|The dose-response relationship for weight loss in dysglycemic participants and participants with T2DM. Percentage change from baseline in body weight at Week 12.|Baseline, Week 12|Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study (two subgroups Dysglycemic had total of 57 patients and T2DM had total of 69 patients) to equal 126|||percentage change||95% Confidence Interval|Number
2532036|NCT03320941|Secondary|Responder Rates According to Percentage Decrease in Body Weight From Baseline to Week 12|The responder rates according to percentage decrease in body weight either ≥ 3%, ≥ 5% or ≥ 10%, from baseline at Week 12, for the overall population and each of the subgroups (Dysglycemic and Type 2 Diabetes Mellitis (T2DM)) from Baseline to Week 12 No Statistical Analysis for >=5% and >=10% was not calculated due to division by zero|Baseline, Week 12|Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study drug|||Percentage of Participants|||Number
2532037|NCT03320941|Primary|Percentage Change From Baseline in Body Weight at Week 12|The dose-response relationship of LIK066 as measured by percent change from baseline in body weight relative to placebo after 12 weeks of treatment.|Baseline, Week 12|Full analysis set (FAS) - includes all 126 randomized participants that took at least one dose of study drug|||Percent Change||95% Confidence Interval|Number
2532038|NCT03320564|Other Pre-specified|Change in Estimated Tumor Stage or Predicted Response to Therapy Between Infiltrated and Non-infiltrated Scans|Response is defined per PERCIST criteria|7 days|||||||
2532039|NCT03320564|Other Pre-specified|Change in Total Lesion Glycolysis of Target Lesions Between Infiltrated and Non-infiltrated Scans|Total lesion glycolysis is calculated for the same metabolic tumor volume as Outcome 2|7 days|||||||
2532040|NCT03320564|Other Pre-specified|Change in Metabolic Tumor Volume of Target Lesions Between Infiltrated and Non-infiltrated Scans|Metabolic tumor volume to be measured using threshold defined in PERCIST criteria|7 days|||||||
2532041|NCT03320564|Primary|Change in SUVpeak of Target Lesions Between Infiltrated and Non-infiltrated Scans|Target lesions selected as per PERCIST criteria. These criteria require more space than allowed to explain. Reference J Nucl Med 2009; 50: 122S-150S. DOI: 10.2967/jnumed.108.057307|Baseline scan and follow up scan within 7 days|Up to 5 target lesions measured per participant (4 for this subject) with mean and standard deviation reported below.|||SUV (dimensionless)||Standard Deviation|Mean
2532042|NCT03320096|Secondary|Number of Participants Who Showed Improvement With the Starch Iodine Test at Days 30 and 90 Post Second Treatment|Improvement for the starch iodine test was defined as a reduction in the dark blue starch iodine area, both the left and right axilla needed to show improvement for a participant to be classified as improved. The starch iodine test was used to assess the area involved in excessive sweating by visually identifying areas that were actively producing sweat. The test was performed by applying iodine solution to the axilla and allowing the solution to dry. After drying, starch was sprinkled on the area. The light-brown iodine color turns dark purple as iodine-starch complexes form in the liquid medium with the sweat rising to the surface of the affected area. Starch iodine test was captured with digital images.|Days 60 (30 days post second treatment) and 120 (90 days post second treatment)|The FAS was the subset of participants in the SES for whom the primary efficacy variable was available (that is, all participants who had baseline and at least one post-baseline value of the primary efficacy variable). The SES was the subset of all participants who were exposed to study treatment at least once.|||participants|||Number
2532043|NCT03320096|Secondary|Number of Participants With Gravimetric Axillary Sweat Reduction by at Least 50 Percent (%) at Days 30 and 90 Post Second Treatment|Treatment success for gravimetric sweat production test was defined as a 50% or more reduction in spontaneous sweat production compared to baseline at 30 days and 90 days post second treatment. Gravimetric sweat production was measured using a pre-weighed filter paper placed into the axilla for a period of 5 minutes. The paper was removed and weighed and rate of sweat production was calculated in milligram per 5 minute (mg/5 min) based on the difference in end-weight and pre-weight.|Days 60 (30 days post second treatment) and 120 (90 days post second treatment)|The FAS was the subset of participants in the SES for whom the primary efficacy variable was available (that is, all participants who had baseline and at least one post-baseline value of the primary efficacy variable). The SES was the subset of all participants who were exposed to study treatment at least once.|||participants|||Number
2532111|NCT03316378|Primary|Movement System|Change in peak ankle power during the stance phase of gait during stair ascent, which will be assessed by syncing movement data from 3-dimensional motion analysis with ground reaction force data from a force plate. Peak positive ankle power reflects the ability of the plantar flexor muscles to concentrically generate speed and force at the ankle joint.|Within session, baseline and 30 minutes after an anesthetic injection||||Watts/kg||95% Confidence Interval|Mean
2532044|NCT03320096|Secondary|Number of Participants With HDSS Score Reduction at Day 90 Post Second Treatment|Treatment success was defined as an HDSS score reduction from a value of a 3 or 4 to a 1 or 2 at 90-day post second treatment. The HDSS was a validated scale used for primary axillary/underarm hyperhidrosis participants. HDSS provides a qualitative measure of the severity of participant's condition based on how it affects their daily activities. It is a 4-point scale (1-4) with scores as: 1 (underarm sweating was never noticeable and never interferes with daily activities); 2 (underarm sweating was tolerable but sometimes interferes with daily activities); 3 (underarm sweating was barely tolerable and frequently interferes with daily activities); and 4 (underarm sweating was intolerable and always interferes with daily activities).|Day 120 (90 days post second treatment)|The FAS was the subset of participants in the SES for whom the primary efficacy variable was available (that is, all participants who had baseline and at least one post-baseline value of the primary efficacy variable). The SES was the subset of all participants who were exposed to study treatment at least once.|||participants|||Number
2532045|NCT03320096|Primary|Number of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Reduction at Day 30 Post Second Treatment|Treatment success was defined as a reduction on the HDSS score from a value of 3 or 4 at baseline to a 1 or 2 at 30-day post second treatment. The HDSS was a validated scale used for primary axillary/underarm hyperhidrosis participants. HDSS provides a qualitative measure of the severity of participant's condition based on how it affects their daily activities. It is a 4-point scale (1-4) with scores as: 1 (underarm sweating was never noticeable and never interferes with daily activities); 2 (underarm sweating was tolerable but sometimes interferes with daily activities); 3 (underarm sweating was barely tolerable and frequently interferes with daily activities); and 4 (underarm sweating was intolerable and always interferes with daily activities).|Day 60 (30 days post second treatment)|All evaluable treated participants in FAS who received a complete or partial study treatment and completed a follow-up visit at Day 30 post second treatment. The FAS was the subset of participants in SES for whom primary efficacy variable was available. The SES was the subset of all participants who were exposed to study treatment at least once.|||participants|||Number
2532046|NCT03319810|Primary|Change in Baseline Retinal Amyloid Imaging (RAI) at 3 Months|This is a noninvasive imaging technique that can detect amyloid-beta deposition in the retinas of the eye.|Baseline to 3 months||||autofluorescent spot count||Standard Deviation|Mean
2532047|NCT03319810|Primary|Change in Baseline Standard Uptake Ratio Values (SUVr) of Florbetapir PET at 3 Months|Amyloid deposition in the brain is thought to lead to the development of cognitive decline and conversion to AD. Each participant's amyloid burden can also be quantified through the computation of a Standard Uptake Value ratio (SUVr).|Baseline to 3 months||||standard uptake value ratio||Standard Deviation|Mean
2532048|NCT03319719|Secondary|Number of Participants With Incidence of Any CTR by Duration Evaluated Using Participant Diaries|CTR were evaluated using participant diaries. Participants recorded daily in the diary any pre-defined CTR that occurred. These CTR included swelling, firmness, lumps/bumps, bruising, pain, tenderness upon pressing, redness, discoloration (not redness or bruising), itching, stinging/burning, and numbness.|Baseline up to Week 6|The SES included all participants who were enrolled into the study, randomized, and received an injection. Participants who were evaluable for this measure at given time period were included.|||participants|||Number
2532049|NCT03319719|Secondary|Number of Participants With Incidence of Any CTR by Severity Evaluated Using Participant Diaries|CTR were evaluated using participant diaries. Participants recorded daily in the diary any pre-defined CTR that occurred. These CTR included swelling, firmness, lumps/bumps, bruising, pain, tenderness upon pressing, redness, discoloration (not redness or bruising), itching, stinging/burning, and numbness.|Baseline up to Week 6|The SES included all participants who were enrolled into the study, randomized, and received an injection. Participants who were evaluable for this measure at given time period were included.|||participants|||Number
2532050|NCT03319719|Secondary|Number of Participants With Incidence of Any Common Treatment Site Response (CTR) Evaluated Using Participant Diaries|CTR were evaluated using participant diaries. Participants recorded daily in the diary any pre-defined CTR that occurred. These CTR included swelling, firmness, lumps/bumps, bruising, pain, tenderness upon pressing, redness, discoloration (not redness or bruising), itching, stinging/burning, and numbness.|Baseline up to Week 6|The SES included all participants who were enrolled into the study, randomized, and received an injection.|||participants|||Number
2532051|NCT03319719|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||Baseline up to Week 6|The SES included all participants who were enrolled into the study, randomized, and received an injection.|||participants|||Number
2532052|NCT03319719|Secondary|Percentage of Responders With Greater Than or Equal to (>=) 1-point Improvement as Evaluated Using Merz NLF Scale at Week 6|The Merz NLF scale was used to measure the aesthetic effectiveness of the study products. Each NLF was assessed separately. The Merz NLF scale is a 5-grade scale ranging from 0 (no folds) to 4 (very severe folds). Response was defined >=1-point improvement on the Merz NLF Scale for each NLF compared to baseline.|Week 6|The FAS included all randomized participants and was analyzed as randomized. Participants who were evaluable for this measure at given time period were included.|||percentage of participants|||Number
2532053|NCT03319719|Primary|Mean Pain Using Visual Analog Scale (VAS)|Pain was assessed using a using a 10 centimeter (cm) VAS. It included 21-numbered circles at 0.5 cm increments, spanning 10 cm total, and was anchored by word descriptors. The VAS scores ranged from 0 (no pain) to 10 (very severe pain).The level of pain was evaluated for each NLF independently immediately upon completion of injection (time zero) on Day 1.|Day 1|The full analysis set (FAS) included all randomized participants and were analyzed as randomized.|||score on a scale||Standard Deviation|Mean
2532054|NCT03319407|Primary|Somatosensory Evoked Potential Monitoring|Recording of somatosensory evoked potential in patients undergoing genitourinary surgery|in the first 24 hours of postoperative period|Study terminated prematurely. Data was not collected.||||||
2532055|NCT03319277|Secondary|Number of Patients Willing to Destroy Excess Remaining Opioid Tablets|"Patient answered yes to the following question: Would you be willing to destroy any remaining opiate pain medication?"|6-weeks after surgery||||Participants|||Count of Participants
2532056|NCT03319277|Secondary|Number of Opiate Tablets Used by Patients|Total number of prescribed tablets used by patients|6-weeks after surgery||||number of tablets||Inter-Quartile Range|Median
2532057|NCT03319277|Primary|Number of Patients Reporting Adequate Satisfaction|"Patient satisfaction was easured by the way they answered the following question: Overall, how satisfied are you with your pain medication at home since your surgery? Their answers were recorded via a rated scale with five options: Very Satisfied, Somewhat Satisfied, Neutral, Somewhat Satisfied, and Very Unsatisfied which goes from most favorable to least favorable, respectively. Patients who answered either Very Satisfied or Somewhat Satisfied were defined a priori to have adequate satisfaction."|6-weeks after surgery|Two patients in the decreased opiate prescription group did not complete the follow-up survey.|||Participants|||Count of Participants
2532058|NCT03319212|Secondary|Tear Film Lipid Pattern|Tear film lipid pattern was recorded for each eye using the following categories: None, Open Meshwork, Closed (Tight Meshwork), Flow (Wave), Amorphous, Colors, and Other.|4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||eyes|Eyes||Number
2532059|NCT03319212|Secondary|Tear Film Stability|Non-invasive tear break-up time (NIBUT) was measured for each eye to indicate the stability of the tear film. NIBUT is measured as the time interval in seconds after the final blink to the first appearance of distortion in the reflected rings; or to the time that the participant has to blink due to discomfort. Three measurements were taken on each eye. The average NIBUT was reported for each group.|4-Week Follow-up|All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.|||seconds|Eyes|Standard Deviation|Mean
2532060|NCT03319212|Secondary|Tear Film Lipid Layer Thickness|Tear film lipid layer thickness was measured for each eye using LipiView II. The Review Lipid Images screen provided numerical analysis of the measured lipid layer thickness in nanometers (nm) from 10 (thinnest) to 240 (thickest), with a precision of 1 nm and an accuracy of 10 nm.|4-Week Follow-up|All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.|||nm|Eyes|Standard Deviation|Mean
2532061|NCT03319212|Secondary|Corneal Staining|Corneal staining was assessed for each eye by region (Central, Superior, Inferior, Nasal, Temporal). Corneal staining type was evaluated using the following the scale: Grade 0 = None, Grade 1 = Micropunctate, Grade 2 = Macropunctate, Grade 3 = Coalesced Macropunctate, and Grade 4 = Patch (>1mm). Corneal staining area was evaluated using the following the scale: Grade 0 = 0% of region covered, Grade 1 = 10% of region covered, Grade 2 = 20% of region covered, Grade 3 = 30% of region covered, Grade 4 = 40% of region covered, Grade 5 = 50% of region covered, Grade 6 = 60% of region covered, Grade 7 = 70% of region covered, Grade 8 = 80% of region covered, Grade 9 = 90% of region covered, and Grade 10 = 100% of region covered. The following scale was used in the grading of corneal staining depth: Grade 0 = None, Grade 0 = Superficial epithelial, Grade 2 = Full epithelial, and Grade 3 = Stromal glow.|4-Week Follow-up|All subjects dispensed a study lens.|||eyes|Eyes||Number
2532062|NCT03319212|Secondary|Conjunctival Staining|Conjunctival staining was assessed for each eye by quadrant (Superior, Inferior, Nasal, Temporal) utilizing the following scale: Grade 0 = None (No conjunctival staining), Grade 1 = Trace (Scattered superficial punctate staining), Grade 2 = Mild (Regional or generalized punctate staining), Grade 3 = Moderate (Significant coalesced punctate staining), Grade 4 = Severe (Patch staining).|4-Week Follow-up|All subjects dispensed a study lens.|||eyes|Eyes||Number
2532063|NCT03319212|Secondary|Conjunctival Redness|Limbal and bulbar conjunctival redness were assessed or each quadrant (nasal, temporal, inferior, superior) using the following scale: 0 = Normal, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe.|4-Week Follow-up|All subjects dispensed a study lens.|||eyes|Eyes||Number
2532064|NCT03319212|Primary|Conjunctival Folds|Lid-parallel conjunctival folds (LIPCOF) will be evaluated in the area perpendicular to the temporal and nasal limbus on the bulbar conjunctiva above the lower lid (temporal and nasal LIPCOF, respectively), and classified using the LIPCOF grading scale: 0 = No conjunctival folds, 1 = One permanent and clear parallel fold, 2 = Two permanent and clear parallel folds (normally lower than 0.2mm), and 3 = More than two permanent and clear parallel folds (normally higher than 0.2mm).|4-Week Follow-up|All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.|||eyes|Eyes||Number
2532065|NCT03319212|Primary|Lid Wiper Epitheliopathy|Horizontal length of staining and sagittal width of staining were graded for both upper and lower lids for each eye. Average grade was calculated separately for upper and lower lids, and the final grade was calculated as the average grade across upper and lower lids. Mean and standard deviation were reported for the final grade by stratum. Subjects were classified according to their final lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Final Grades range from 0 to 3, where higher final grades indicate worsening lid wiper epitheliopathy.|4-Week Follow-up|All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.|||Units on a scale|Eyes|Standard Deviation|Mean
2532066|NCT03319212|Primary|Lid Margin Evaluation: Number of Eyes With Abnormal Biomicroscopy Findings|"Lid margin evaluation was conducted for upper and lower lids for both left and right eyes. The presence of the following biomicroscopy findings were recorded as No/normal or Yes/abnormal:~Irregularity: Notching of Margin~Vascularity of Lid Margin: Telangiectasia~Meibomian Gland Pouting, Plugging, or Capping~Lid/Lash Margin Debris Findings.~The number of positive findings (yes) was reported for each group."|4-Week Follow-up|All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.|||Number of eyes|Eyes||Number
2532088|NCT03317431|Secondary|the Expression of DDC in Lung Tissues|ImageJ software were used to get the Integrated Optical Density(IOD) of the chemiluminescent signal from the membranes of Dopa decarboxylase(DDC). The normalization was carried out by DDC IOD/total β-actin IOD for sample loading correction. In determination of the expression level of DDC in different time points, the investigators had a bulk preparation of normal placental protein which was set as a control. Analyze the correlation between duration of mechanical ventilation and DDC expression. If p value is less than 0.05, then its change is statically significant.|20min-60min||||pearson correlation coefficient|||Number
2537390|NCT03136068|Secondary|Number of Patients With Reported Fetal Death Prior to Procedure|number of patients who had fetal death measured by ultrasound|Day 2, before procedure|number of patients who had reported fetal death on day 2|||Participants|||Count of Participants
2532067|NCT03319212|Primary|Meibomian Gland Expressibility|Meibomian glands were assessed in the three regions of each lower eyelid: temporal, central, and nasal. Approximately five glands are expressed per region with each use of the Meibomian Gland Evaluator. Secretions for each of the 5 glands selected within the three regions were graded using the following secretion grading scale: Grade 0 = No Secretion (Includes capped orifices), Grade 1 = Inspissated (semi-solid, toothpaste-like consistency), Grade 2 = Colored/Cloudy Liquid, Grade 3 = Clear Liquid Oil. The total grades for 5 glands per region was calculated for each subject. The total Meibomian Gland Secretion Score was calculated by adding the grades for the 15 glands assessed. Mean and standard deviation for total grade per region and total Meibomian Gland Secretion Score were reported for each stratum. Total scores range from 0 to 15 were lower score indicate worsening meibomian gland expressability.|4-Week Follow-up|All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.|||Score on a Scale|Eyes|Standard Deviation|Mean
2532068|NCT03319212|Primary|Meibomian Gland Imaging|Meibomian gland imaging was assessed in each each subject eye, at baseline, 4-Week Follow-up (during lens wear) and the the 5-Week Follow-up on subjects' bare eyes. Meibomian gland imaging is expressed interms of area of loss using the following grading scale: Degree 0 ≈ 0%; Degree 1 ≤ 25%; Degree 2 26% - 50%; Degree 3 51% - 75%; Degree 4 ≥ 75%.|4-Week Follow-up|All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.|||eyes|Eyes||Number
2532069|NCT03319173|Secondary|Adenosine|Assessment of changes in Adenosine Range: 20-80 nmol/L|12-weeks||||nmol/L||95% Confidence Interval|Geometric Least Squares Mean
2532070|NCT03319173|Secondary|SAH (S-adenosylhomocysteine)|Assessment of changes in SAH (S-adenosylhomocysteine) Range: 10-22 nmol/L|12-weeks||||nmol/L||95% Confidence Interval|Geometric Least Squares Mean
2532071|NCT03319173|Secondary|SAM (S-adenosylmethionine)|Assessment of changes in SAM (S-adenosylmethionine)|12-weeks||||nmol/L||95% Confidence Interval|Geometric Least Squares Mean
2532072|NCT03319173|Secondary|SAM/SAH Ratio (S-adenosylmethionine/S-adenosylhomocysteine)|Assessment of changes in SAM/SAH (S-adenosylmethionine/S-adenosylhomocysteine) ratio Range: >4.0|12-weeks||||ratio||95% Confidence Interval|Geometric Least Squares Mean
2532073|NCT03319173|Secondary|VLDL|Assessment of changes in VLDL (very low density lipoprotein carrier) over time. Ranges: < 5-40 mg/dL|12-weeks||||mg/dL||95% Confidence Interval|Geometric Least Squares Mean
2532074|NCT03319173|Secondary|Body Fat Mass (BFM)|Assessment of changes in body fat mass over time as measured in pounds.|12-weeks||||pounds||95% Confidence Interval|Geometric Least Squares Mean
2532075|NCT03319173|Secondary|Weight|Assessment of changes in weight over time as measured in pounds.|12-weeks||||pounds||95% Confidence Interval|Geometric Least Squares Mean
2532076|NCT03319173|Secondary|HgA1c|Assessment of changes in HgA1c (Hemoglobin A1c) over time.|12-weeks||||percentage of glycated hemoglobin||95% Confidence Interval|Geometric Least Squares Mean
2532077|NCT03319173|Secondary|HOMA-IR|Assessment of changes in HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) over time. Ranges: < 1.0|12-weeks||||units on a scale||95% Confidence Interval|Geometric Least Squares Mean
2532078|NCT03319173|Secondary|Fasting Glucose|Assessment of changes in fasting glucose over time. Ranges: < 74-100 mg/dL|12-weeks||||mg/dL||95% Confidence Interval|Geometric Least Squares Mean
2532079|NCT03319173|Secondary|Fasting Insulin|Assessment of changes in fasting insulin over time. Ranges: < 2.6-11.1 mU/L|12-weeks||||mU/L||95% Confidence Interval|Geometric Least Squares Mean
2532080|NCT03319173|Secondary|Triglyceride/HDL Ratio|Assessment of changes in Triglyceride/HDL ratio over time.|12 weeks||||ratio||95% Confidence Interval|Geometric Least Squares Mean
2532081|NCT03319173|Secondary|Fasting Triglycerides|Assessment of changes in fasting triglycerides over time. Ranges: < 150 mg/dL|12 weeks||||mg/dL||95% Confidence Interval|Geometric Least Squares Mean
2532082|NCT03319173|Secondary|NMR Lipoprofile Particle Size - LP-IR Score (Lipoprotein Insulin Resistance) Ideal Range: <45|Lipoprotein insulin resistance (LP-IR) is an aggregate score of the 6 lipoprotein parameters range from 0 to 100, with higher scores indicating greater insulin resistance (IR).|12 weeks||||score on a scale||95% Confidence Interval|Geometric Least Squares Mean
2532083|NCT03319173|Secondary|NMR Lipoprofile Particle Size - Small LDL-P|Assessment of changes in Small LDL-P (total small Pattern B)|12 weeks||||nmol/L||Standard Error|Geometric Least Squares Mean
2532084|NCT03319173|Primary|MoCA (Montreal Cognitive Assessment)|Measures changes in cognitive function over time. Score: 30 points (maximum), 0 points (minimum). Score >25 = normal cognitive function. Score 17-25 = mild cognitive impairment (MCI). Score <17 = increased likelihood of Alzheimer's Disease or dementia.|12 weeks||||score on a scale||Standard Error|Least Squares Mean
2532085|NCT03318341|Primary|Feasibility - User Compliance in Wearing the Device||Two 1-month durations||||Participants|||Count of Participants
2532086|NCT03318341|Primary|Safety - Occurrence of Device-Related Adverse Events (AE)|Any worsening of hand sensation, dexterity, grip strength, upper limb pain, swelling, spasticity, skin irritation, or any other adverse events (assessed every week) that sustained until the end of the month or occurred at the end of the month.|Two 1-month durations||||Participants|||Count of Participants
2532087|NCT03317431|Secondary|the Expression of Ac-a-tubulin in Lung Tissues|ImageJ software were used to get the Integrated Optical Density(IOD) of the chemiluminescent signal from the membranes of acetylated-a-tubulin(Ac-a-tubulin). The normalization was carried out by Ac-a-tubulin IOD/total β-actin IOD for sample loading correction. In determination of the expression level of Ac-a-tubulin in different time points, the investigators had a bulk preparation of normal placental protein which was set as a control. Analyze the correlation between duration of mechanical ventilation and Ac-a-tubulin expression. If p value is less than 0.05, then its change is statically significant.|20min-60min||||pearson correlation coefficient|||Number
2532100|NCT03316911|Other Pre-specified|3-Month Sexual Violence Knowledge|An 8-item (investigator created) scale will be used to measure participants' sexual violence knowledge at 3-months. The investigator-created sexual violence knowledge questions are scored from 1 (Strongly Agree) to 5 (Strongly Disagree) and the scores will be reverse-coded and summed for a total sexual violence knowledge score ranging from 8 - 40, with higher scores indicating more sexual violence knowledge.|3-months||||score on a scale||Standard Deviation|Mean
2532089|NCT03317431|Secondary|the Expression of TH in Lung Tissues|ImageJ software were used to get the Integrated Optical Density(IOD) of the chemiluminescent signal from the membranes of Tyrosine hydroxylase(TH). The normalization was carried out by TH IOD/total β-actin IOD for sample loading correction. In determination of the expression level of TH in different time points, the investigators had a bulk preparation of normal placental protein which was set as a control. Analyze the correlation between duration of mechanical ventilation and TH expression. If p value is less than 0.05, then its change is statically significant.|20min-60min||||pearson correlation coefficient|||Number
2532090|NCT03317431|Secondary|Correlation Coefficient (r) Between Duration of Mechanical Ventilation and DRD2 Expression|ImageJ software were used to get the Integrated Optical Density(IOD) of the chemiluminescent signal from the membranes of dopamine receptor 2(DRD2). The normalization was carried out by DRD2 IOD/total β-actin IOD for sample loading correction. In determination of the expression level of DRD2 in different time points, the investigators had a bulk preparation of normal placental protein which was set as a control. Analyze the correlation between duration of mechanical ventilation and DRD2 expression. If p value is less than 0.05, then its change is statically significant.|20min-60min||||pearson Correlation coefficient|||Number
2532091|NCT03317431|Primary|Correlation Coefficient (r) Between Duration of Mechanical Ventilation and DRD1 Expression|ImageJ software were used to get the Integrated Optical Density(IOD) of the chemiluminescent signal from the membranes of dopamine receptor 1(DRD1). The normalization was carried out by DRD1 IOD/total β-actin IOD for sample loading correction. In determination of the expression level of DRD1 in different time points, the investigators had a bulk preparation of normal placental protein which was set as a control. Analyze the correlation between duration of mechanical ventilation and DRD1 expression. If p value is less than 0.05, then its change is statically significant.|20min-60min||||pearson Correlation Coefficient|||Number
2532092|NCT03316976|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole||Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose|The PK set included all participants who received at least 1 dose of study drug and had at least 1 measureable plasma concentration of dexlansoprazole.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2532093|NCT03316976|Primary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole||Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose|The PK set included all participants who received at least 1 dose of study drug and had at least 1 measureable plasma concentration of dexlansoprazole.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2532094|NCT03316976|Primary|Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole||Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose|The pharmacokinetics (PK) set included all participants who received at least 1 dose of study drug and had at least 1 measureable plasma concentration of dexlansoprazole.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2532095|NCT03316911|Other Pre-specified|5-Month Rape Myth Acceptance|The 22-item modified Illinois Rape Myth Acceptance scale will be used to measure attitudes endorsing rape myths at 5-months. The modified Illinois Rape Myth Acceptance Scale (McMahon & Farmer, 2011) is scored from 1 (Strongly Agree) to 5 (Strongly Disagree). It includes four sub-scales (She asked for it, He didn't mean to, It wasn't really rape, and She lied). The items in each sub-scale can be summed for a total score and the scores for the entire scale can be summed for a cumulative score. Scores on the full scale range from 22-110. Scores on the She Asked For It and He Didn't Mean To sub-scales range from 6-30. Scores on the It Wasn't Really Rape and the She Lied sub-scales range from 5-25. Higher scores indicate greater rejection of rape myths.|5-months|One participant from the Control group had missing data and was not included in data analysis for the Rape Myth Acceptance measures.|||score on a scale||Standard Deviation|Mean
2532096|NCT03316911|Other Pre-specified|3-Month Rape Myth Acceptance|The 22-item modified Illinois Rape Myth Acceptance scale will be used to measure attitudes endorsing rape myths at 3-months. The modified Illinois Rape Myth Acceptance Scale (McMahon & Farmer, 2011) is scored from 1 (Strongly Agree) to 5 (Strongly Disagree). It includes four sub-scales (She asked for it, He didn't mean to, It wasn't really rape, and She lied). The items in each sub-scale can be summed for a total score and the scores for the entire scale can be summed for a cumulative score. Scores on the full scale range from 22-110. Scores on the She Asked For It and He Didn't Mean To sub-scales range from 6-30. Scores on the It Wasn't Really Rape and the She Lied sub-scales range from 5-25. Higher scores indicate greater rejection of rape myths.|3-months||||score on a scale||Standard Deviation|Mean
2532097|NCT03316911|Other Pre-specified|5-Month Sexual Relationship Power|Fifteen items from the Relationship Control sub-scale of the Sexual Relationship Power Scale will be used to measure power dynamics within participants' sexual relationships at 5-months. The Relationship Control Sub-scale Items (Pulerwitz, Gortmaker, & DeJong, 2000) are scored from 1 (Strongly Agree) to 4 (Strongly Disagree). Scores are summed with total scores ranging from 15-60. Higher scores represent higher sexual relationship power.|5-months|"Only participants who chose a relationship status other than Single were asked the SRPS questions."|||score on a scale||Standard Deviation|Mean
2532098|NCT03316911|Other Pre-specified|3-Month Sexual Relationship Power|Fifteen items from the Relationship Control sub-scale of the Sexual Relationship Power Scale will be used to measure power dynamics within participants' sexual relationships at 3-months. The Relationship Control Sub-scale Items (Pulerwitz, Gortmaker, & DeJong, 2000) are scored from 1 (Strongly Agree) to 4 (Strongly Disagree). Scores are summed with total scores ranging from 15-60. Higher scores represent higher sexual relationship power.|3-months|"Only participants who chose a relationship status other than Single were asked the SRPS questions."|||score on a scale||Standard Deviation|Mean
2532099|NCT03316911|Other Pre-specified|5-Month Sexual Violence Knowledge|An 8-item (investigator created) scale will be used to measure participants' sexual violence knowledge at 5-months. The investigator-created sexual violence knowledge questions are scored from 1 (Strongly Agree) to 5 (Strongly Disagree) and the scores will be reverse-coded and summed for a total sexual violence knowledge score ranging from 8 - 40, with higher scores indicating more sexual violence knowledge.|5-months||||score on a scale||Standard Deviation|Mean
2532112|NCT03316378|Primary|Pain Psychology|Tampa Scale of Kinesiophobia (TSK, score range 17 to 68). A decrease in TSK would indicate a decrease in fear of injury (and/or re-injury)|Within session, baseline and 30 minutes after an anesthetic injection||||units on a scale||95% Confidence Interval|Mean
2532101|NCT03316911|Other Pre-specified|5-Month Sexual Violence Perpetration|The 10-item Sexual Experiences Survey will be used to measure participants' experiences of sexual violence perpetration. The revised Sexual Experiences Survey - Short Form Perpetration (Koss et al., 2007) includes seven items that are used to assess the frequency of perpetration of sexual violence behaviors and three questions that explore the sex of the victims and if the individual believes they have perpetrated a rape. We will be using these to assess the number of times an individual has perpetrated sexual violence over the last 5 months from 0 to 3+ times. The results will be scored as a percentage of participants who have perpetrated each individual behavior and the percentage who believe they have perpetrated a rape.|5-months||||Participants|||Count of Participants
2532102|NCT03316911|Other Pre-specified|3-Month Sexual Violence Perpetration|The 10-item Sexual Experiences Survey will be used to measure participants' experiences of sexual violence perpetration. The revised Sexual Experiences Survey - Short Form Perpetration (Koss et al., 2007) includes seven items that are used to assess the frequency of perpetration of sexual violence behaviors and three questions that explore the sex of the victims and if the individual believes they have perpetrated a rape. We will be using these to assess the number of times an individual has perpetrated sexual violence over the last 3 months from 0 to 3+ times. The results will be scored as a percentage of participants who have perpetrated each individual behavior and the percentage who believe they have perpetrated a rape.|3-months||||Participants|||Count of Participants
2532103|NCT03316911|Other Pre-specified|5-Month Sexual Violence Victimization|The 10-item Sexual Experiences Survey will be used to measure participants' experiences of sexual violence victimization. The revised Sexual Experiences Survey - Short Form Victimization (Koss et al., 2007) includes 10 items that are used to assess the frequency of seven victimization behaviors and then uses three questions to explore the sex of the perpetrator and if the participant believes they were raped. We will be items 1-7 to assess the number of times an individual has experienced victimization over the last 5 months from 0 to 3+ times. The results will be scored as a percentage of participants who have experienced each individual behavior and the percentage who report that they have experienced a rape.|5-months||||Participants|||Count of Participants
2532104|NCT03316911|Other Pre-specified|3-Month Sexual Violence Victimization|The 10-item Sexual Experiences Survey will be used to measure participants' experiences of sexual violence victimization. The revised Sexual Experiences Survey - Short Form Victimization (Koss et al., 2007) includes 10 items that are used to assess the frequency of seven victimization behaviors and then uses three questions to explore the sex of the perpetrator and if the participant believes they were raped. We will be items 1-7 to assess the number of times an individual has experienced victimization over the last 3 months from 0 to 3+ times. The results will be scored as a percentage of participants who have experienced each individual behavior and the percentage who report that they have experienced a rape.|3-months||||Participants|||Count of Participants
2532105|NCT03316911|Secondary|5-Month Retention|The retention rate will be calculated based on how many participants in the intervention group have completed the follow-up surveys. A total retention score (those retained/those enrolled) will be computed based on interaction with the WebApp.|5-months|Retention was calculated based on the total number of participants that completed the Baseline survey.|||Participants|||Count of Participants
2532106|NCT03316911|Secondary|3-Month Retention|The retention rate will be calculated based on how many participants in the intervention group have completed the follow-up surveys. A total retention score (those retained/those enrolled) will be computed based on interaction with the WebApp.|3-months|Retention was calculated based on the total number of participants that completed the Baseline survey.|||Participants|||Count of Participants
2532107|NCT03316911|Primary|5-Month Acceptability|The 5-item System Acceptability Scale (investigator created) will be used to evaluate the acceptability of the WebApp in the intervention group only. An investigator-created acceptability scale with 5-items will be used to measure acceptability. Four items are scored from 1 (Strongly Agree/Very Likely) to 5 (Strongly Disagree/Very Unlikely) and will be reverse coded. One item assess the frequency of use of the WebApp from 1 (Never) to 5 (Multiple times a week). All five items will be summed for a total score. Scores range from 5-25, with higher scores indicating greater acceptability.|5-months|Only intervention participants were asked the items on the System Acceptability Scale.|||score on a scale||Standard Deviation|Mean
2532108|NCT03316911|Primary|3-Month Acceptability|The 5-item System Acceptability Scale (investigator created) will be used to evaluate the acceptability of the WebApp in the intervention group only. An investigator-created acceptability scale with 5-items will be used to measure acceptability. Four items are scored from 1 (Strongly Agree/Very Likely) to 5 (Strongly Disagree/Very Unlikely) and will be reverse coded. One item assess the frequency of use of the WebApp from 1 (Never) to 5 (Multiple times a week). All five items will be summed for a total score. Scores range from 5-25, with higher scores indicating greater acceptability.|3-months|Only intervention participants were asked the items on the System Acceptability Scale.|||score on a scale||Standard Deviation|Mean
2532109|NCT03316911|Primary|5-Month Usability|The 10-item System Usability Scale will be used to evaluate the usability of WebApp in the intervention group only. The System Usability Scale (Brook, 1996) includes 10 items that are rated from 1 (Strongly Disagree) to 5 (Strongly Agree). To get a final score the: 1) First, one is subtracted from the score of the odd items; 2) Second, the responses are subtracted from 5 for the even-numbered items; 3) Then the responses are summed and multiplied by 2.5 to get a range of 0-100. A score above 68 is considered above average.|5-months|Only intervention participants were asked the items on the System Usability Scale.|||score on a scale||Standard Deviation|Mean
2532110|NCT03316911|Primary|3-Month Usability|The 10-item System Usability Scale will be used to evaluate the usability of WebApp in the intervention group only. The System Usability Scale (Brook, 1996) includes 10 items that are rated from 1 (Strongly Disagree) to 5 (Strongly Agree). To get a final score the: 1) First, one is subtracted from the score of the odd items; 2) Second, the responses are subtracted from 5 for the even-numbered items; 3) Then the responses are summed and multiplied by 2.5 to get a range of 0-100. A score above 68 is considered above average.|3-months|Only intervention participants were asked the items on the System Usability Scale.|||score on a scale||Standard Deviation|Mean
2532186|NCT03314753|Primary|Number of Reconnected Pulmonary Veins as Documented in the Cath Lab / Imaging at the Time of Re-ablation Procedure|Number of reconnected pulmonary veins as documented in cath lab / imaging|At time of re-ablation||||Reconnected Pulmonary Veins||Standard Deviation|Mean
2532113|NCT03316378|Primary|Central Sensitization|Pressure pain threshold (PPT) at heel on contralateral side. A pressure algometer (Somedic, Farsta, Sweden) was applied perpendicular to the skin at a rate of 50 kilopascal/s with a 1cm2 tip. The participants pressed a button when the sensation of pressure first became painful (1/10 on NPRS). The mean of 3 trials per area represented the PPT.|Within session, baseline and 30 minutes after an anesthetic injection||||kilopascal||95% Confidence Interval|Mean
2532114|NCT03316131|Primary|Change From Baseline in Area Under Plasma Concentration Time Curve Over a Dosing Interval (24 Hours) (AUCτ) on Day 7|AUCτ assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin|On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)|Pharmacokinetic Analysis Set|||h∙ng/mL||Geometric Coefficient of Variation|Geometric Mean
2532115|NCT03316131|Secondary|Change From Baseline in Time of Last Measurable Concentration (Tlast) on Day 7|tlast assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin|On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)|Pharmacokinetic Analysis Set|||hour||Full Range|Median
2532116|NCT03316131|Secondary|Change From Baseline in Time to Reach Maximum Observed Concentration (Tmax) on Day 7|tmax assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin|On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)|Pharmacokinetic Analysis Set|||hour||Full Range|Median
2532117|NCT03316131|Secondary|Change From Baseline in Urinary Excretion of Serum UA (sUA) on Day 7|Change from baseline in sUA to assess the intensive UA lowering effect of RDEA3170, febuxostat and dapagliflozin by evaluating the sUA levels after 7 days of treatment.|At Day -1 and Day 7|Pharmacodynamic Analysis Set|||umol/L||95% Confidence Interval|Least Squares Mean
2532118|NCT03316131|Primary|Change From Baseline in Area Under Plasma Concentration Time Curve From Time Zero to the Time of Last Measurable Concentration (AUClast) on Day 7|AUClast assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin|On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)|Pharmacokinetic Analysis Set|||h∙ng/mL||Geometric Coefficient of Variation|Geometric Mean
2532119|NCT03316131|Primary|Change From Baseline in Plasma Concentration (Cmax) on Day 7|Cmax assessment for Verinurad, M1, and M8 following daily oral administration of verinurad and febuxostat with and without dapagliflozin|On Treatment Period 1 and 2: Day 7 (Pre-dose and 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 8, 12 and 24 hours post-dose)|Pharmacokinetic Analysis Set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2532120|NCT03316131|Primary|Change From Baseline in Peak Urinary Excretion of Uric Acid (UA) on Day 7|Change from baseline in peak UA excretion during the first 8 hours on Day 7 of treatment to assess the effects of intensive UA lowering therapy with verinurad, febuxostat and dapagliflozin. Urine sample was collected in hourly intervals, and the highest amount of UA excreted in any interval was designated as peak UA excretion for each patient and treatment period.|On Day -1 and Day 7 of each treatment period|Protocol Analysis Set|||milligrams (mg)||95% Confidence Interval|Least Squares Mean
2532121|NCT03316105|Primary|The Effect of T6 Dermatomal Electrical Stimulation on Subjects Stomach Motor Activity|Testing to see if dermatomal electrical stimulation will speed up or slow down the stomach motor activity.|through study completion, an average of 1 year|Electrical device malfunction; recruitment was stopped.||||||
2532122|NCT03315780|Secondary|Number of Participants Who Develop Hypoglycemic Events|Number of participants who develop hypoglycemic events.|Baseline through 4 weeks|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2532123|NCT03315780|Secondary|Change From Baseline in Triglyceride Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])|LS mean of triglyceride change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect.|Baseline, 4 Weeks|All participants who received at least one dose of study drug and had evaluable triglyceride data.|||mg*h/dL||95% Confidence Interval|Least Squares Mean
2532124|NCT03315780|Secondary|Change From Baseline in Glucagon Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])|LS mean of glucagon change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect.|Baseline, 4 Weeks|All participants who received at least one dose of study drug and had evaluable glucagon data.|||picomole*h/Liter (pmol*h/L)||95% Confidence Interval|Least Squares Mean
2532125|NCT03315780|Secondary|Change From Baseline in C-Peptide Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])|LS mean of C-peptide change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect.|Baseline, 4 Weeks|All participants who received at least one dose of study drug and had evaluable c-peptide data.|||nanogram*h/milliliter (ng*h/mL)||95% Confidence Interval|Least Squares Mean
2532126|NCT03315780|Secondary|Change From Baseline in Insulin Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC [0-4h])|LS mean of the insulin change from baseline was analyzed using a mixed-effects linear model. The model includes treatment, sequence, period, week and treat-by-sequence as fixed effects, baseline as a covariate and participant as random effect.|Baseline, 4 Weeks|All participants who received at least one dose of study drug and had evaluable insulin data.|||insulin units*h/mL (µU*h/mL)||95% Confidence Interval|Least Squares Mean
2532127|NCT03315780|Secondary|Change From Baseline in Postprandial Blood Glucose|Change from baseline in postprandial blood glucose at 120 minutes at week 4.|Baseline, 4 Weeks|All participants who received at least one dose of study drug and had evaluable postprandial blood glucose data.|||mg/dL||Standard Error|Mean
2532128|NCT03315780|Secondary|Change From Baseline in Fasting Blood Glucose|Change from baseline in fasting blood glucose obtained at pre-meal.|Baseline, 4 Weeks|All participants who received at least one dose of study drug and evaluable had fasting blood glucose data.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2532129|NCT03315780|Primary|Change From Baseline in Glucose Area Under the Concentration Versus Time Curve From Time Zero to 4 Hours (AUC[0-4h])|Least square (LS) means of glucose AUC 0-4h change from baseline was calculated using mixed-effects linear model. The model will include treatment, sequence, period, week, and treatment-by-week as fixed effects, baseline as a covariate, and participant as random effect.|Baseline, 4 Weeks|All participants who receive at least one dose of study drug and have evaluable pharmacodynamic data.|||milligram*hour per deciliter (mg*h/dL)||95% Confidence Interval|Least Squares Mean
2532130|NCT03315702|Primary|Change in Plasma Concentration of R-spondin4|The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin4 concentration. And the outcome was calculated by subtracting the R-spondin4 plasmid concentration of sample A from the R-spondin4 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin4.|3 hours||||pg/ml||Standard Deviation|Mean
2532131|NCT03315702|Primary|Change in Plasma Concentration of R-spondin3|The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin3 concentration. And the outcome was calculated by subtracting the R-spondin3 plasmid concentration of sample A from the R-spondin3 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin3.|3 hours||||pg/ml||Standard Deviation|Mean
2532132|NCT03315702|Primary|Change in Plasma Concentration of R-spondin 2|The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin2 concentration. And the outcome was calculated by subtracting the R-spondin2 plasmid concentration of sample A from the R-spondin2 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin2.|3 hours||||pg/ml||Standard Deviation|Mean
2532133|NCT03315702|Primary|Change in Plasma Concentration of R-spondin 1|The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin1 concentration. And the outcome was calculated by subtracting the R-spondin1 plasmid concentration of sample A from the R-spondin1 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin1.|3 hours||||pg/ml||Standard Deviation|Mean
2532134|NCT03315572|Secondary|Number of Participants With Attempts Required to Produce an Audible Sound|At the end of cognitive debriefing of the items, the pediatric participants were asked to use the ELLIPTA whistle to produce an audible sound. The number of pediatric participants who required one to two attempts or more than three attempts to produce an audible sound has been presented.|Up to 45 minutes|All enrolled population. Only pediatric participants who participated in Round 1 and Round 2 of the interviews were assessed.|||Participants|||Number
2532135|NCT03315572|Secondary|Number of Pediatric Participants Who Were Able to Use ELLIPTA Whistle|At the end of cognitive debriefing of the items, the interviewers demonstrated how to use the ELLIPTA whistle and then the pediatric participants were provided with a whistle and asked to produce an audible sound. The number of pediatric participants who were able to produce an audible sound using the ELLIPTA whistle has been presented.|Up to 45 minutes|All enrolled population. Only pediatric participants who participated in Round 1 and Round 2 of the interviews were assessed.|||Participants|||Number
2532136|NCT03315572|Primary|Number of Additional Ease of Use Items Identified|Caregivers were asked if there were any concepts regarding ease of use that were missing from the pediatric or caregiver versions according to them. The number of ease of use items as identified by caregiver participants has been presented.|Up to 45 minutes|All enrolled population. Only those caregiver participants who participated in Round 1 and Round 2 of the interviews were assessed.|||Items|||Number
2532137|NCT03315572|Primary|Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 2 Interviews|Based on the results of Round 1 interviews, both the items of caregiver version were retained for further evaluation in Round 2. The number of caregivers who had difficulty in providing responses to caregiver version of items has been presented below.|Up to 45 minutes|All enrolled population. Only those caregiver participants who participated in Round 2 of the interviews were assessed.|||Participants|||Number
2532138|NCT03315572|Primary|Number of Pediatric Participants With Difficulty in Distinguishing Between the Responses to Items-Round 2 Interviews|The items for evaluation in Round 2 included: Item 1 and Item 2 for ease of ELLIPTA use and ease of evaluating remaining doses with a verbal scale of four options (Very easy, Easy, Hard, Very hard) and Item 3 for evaluation of the ability of participants to differentiate between inhalers consisting of three options (Yes, No, The same). The number of pediatric participants who had difficulty in distinguishing between the response to items has been presented.|Up to 45 minutes|All enrolled population. Only those pediatric participants who participated in Round 2 of the interviews were assessed.|||Participants|||Number
2532139|NCT03315572|Primary|Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 2 Interviews|The items for evaluation in Round 2 included: Item 1 and Item 2 for ease of ELLIPTA use and ease of evaluating remaining doses with a verbal scale of four options (Very easy, Easy, Hard, Very hard) and Item 3 for evaluation of the ability of participants to differentiate between inhalers consisting of three options (Yes, No, The same). The number of pediatric participants with difficulty in providing response to items has been presented.|Up to 45 minutes|All enrolled population. Only those pediatric participants who participated in Round 2 of the interviews were assessed.|||Participants|||Number
2532187|NCT03314753|Primary|Number of Participants With Documented Atrial Arrhythmias Prior to Re-ablation|Number of documented atrial arrhythmias as assessed by ECG prior to the re-ablation|At time of re-ablation||||Participants|||Count of Participants
2532188|NCT03314519|Secondary|Accuracy of Detection of Lung Collapse in Ultrasonography Method in Cardiovascular and Thoracic Anesthesia Fellow|Accuracy of detection of lung collapse in thoracic patient with lung ultrasonography in cardiac anaesthesiologist after training lung ultrasonography|30 minutes||||Participants|||Count of Participants
2532140|NCT03315572|Primary|Number of Pediatric Participants With Problems Understanding Item Wording-Round 2 Interviews|Based on the results of Round 1 interviews, the four level verbal response scale (Item 1a and Item 2a) of the pediatric versions were selected for further evaluation of ease of use and ease in evaluating remaining doses in Round 2. The second set of interviews were conducted to test if any further revision is required to optimize the items. The items for evaluation in Round 2 included: Item 1 and Item 2 for ease of ELLIPTA use and ease of evaluating remaining doses with a verbal scale of four options (Very easy, Easy, Hard, Very hard) and Item 3 for evaluation of the ability of participants to differentiate between inhalers consisting of three options (Yes, No, The same). The number of pediatric participants with problems understanding item wording has been presented.|Up to 45 minutes|All enrolled population. Only those pediatric participants who participated in Round 2 of the interviews were assessed.|||Participants|||Number
2532141|NCT03315572|Primary|Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 1 Interviews|Round 1 of the interviews for caregiver participants evaluated the concepts of ease of evaluating remaining doses (Item 1) and the likelihood of requesting inhaler from their child's physician (Item 2). A response scale with four options was developed for each item: Item 1 (Very easy, Easy, Difficult, Very difficult) and Item 2 (Very likely, Likely, Unlikely, Very unlikely). The number of caregivers who had difficulty in providing responses to caregiver items has been reported.|Up to 45 minutes|All enrolled population. Only those caregiver participants who participated in Round 1 of the interviews were assessed.|||Participants|||Number
2532142|NCT03315572|Primary|Number of Pediatric Participants With Difficulty in Distinguishing Between the Item Responses-Round 1 Interviews|Round 1 of the interviews evaluated 3 items to evaluate ease of use of inhaler (Items 1a, 1b and 1c), 3 items to assess the ease in evaluating remaining doses (Items 2a, 2b, 2c) and one item to understand if the participants could compare different types of inhalers. Three response options were developed to assess ease of inhaler use and ease of evaluating remaining doses: Item 1a/2a-a verbal response scale with four options (Very easy, easy, hard, very hard); Item 1b/2b-the same four verbal response options accompanied by illustrations of faces for each verbal response; and Item 1c/2c-a verbal response scale with two options (Yes, No). Item 3 consisted of 3 response options (Yes, No, The same). The number of participants who had difficulty in distinguishing item responses has been presented.|Up to 45 minutes|All enrolled population. Only those pediatric participants who participated in Round 1 of the interviews were assessed.|||Participants|||Number
2532143|NCT03315572|Primary|Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 1 Interviews|Round 1 of the interviews evaluated 3 items to evaluate ease of use of inhaler (Items 1a, 1b and 1c) and 3 items to assess the ease in evaluating remaining doses (Items 2a, 2b, 2c). Three response options were developed for these two concepts: Item 1a/2a-a verbal response scale with four options (Very easy, easy, hard, very hard); Item 1b/2b-the same four verbal response options accompanied by illustrations of faces for each verbal response; and Item 1c/2c-a verbal response scale with two options (Yes, No). The number of participants who had difficulty in providing item responses has been presented.|Up to 45 minutes|All enrolled population. Only those pediatric participants who participated in Round 1 of the interviews were assessed.|||Participants|||Number
2532144|NCT03315572|Primary|Number of Pediatric Participants With Problems Understanding Item Wording-Round 1 Interviews|The items for pediatric participants were developed to assess the concepts of overall ease of use of ELLIPTA and ease of evaluating remaining doses in inhaler. Pediatric participants aged 5 to 7 years were required to complete the interviewer-administered version and participants aged 8 to 11 years were administered self-completed version. Round 1 of the interviews evaluated 3 items to evaluate ease of use of inhaler (Items 1a, 1b and 1c), 3 items to assess the ease in evaluating remaining doses (Items 2a, 2b, 2c) and one item to assess if the pediatric participants could compare different types of inhalers (Item 3). The number of participants who had problems in understanding the item wordings has been presented. No statistical analyses were conducted for this qualitative study.|Up to 45 minutes|All enrolled population. Only those pediatric participants who participated in Round 1 of the interviews were assessed.|||Participants|||Number
2532145|NCT03315559|Secondary|Number of Participants With Vital Signs of Potential Clinical Concern|Vital signs were measured in a supine or semi-supine position after 5 minutes rest and included temperature, systolic and diastolic blood pressure and pulse and respiratory rate. Number of participants with vital signs of potential clinical concern are reported.|Up to 11 weeks|Safety Population|||Participants|||Count of Participants
2532146|NCT03315559|Secondary|Number of Participants With Electrocardiogram Findings of Clinical Significance|Twelve-lead electrocardiogram was measured in a supine or semi-supine position after 5 minutes rest. Number of participants with electrocardiogram findings of clinical significance are presented.|Up to 11 weeks|Safety Population.|||Participants|||Count of Participants
2532147|NCT03315559|Secondary|Number of Participants With Clinically Significant Urinalysis Findings|Urine samples were collected to detect the presence of bilirubin, glucose, ketones, leukocyte esterase, nitrite, occult blood, protein and urobilinogen. Urinalysis also included measurement of specific gravity and pH. Number of participants with clinically significant urinalysis findings are presented.|Up to 168 hours|Safety Population.|||Participants|||Count of Participants
2532148|NCT03315559|Secondary|Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern|Clinical chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, chloride, cholesterol, gamma glutamyl transferase, globulin, protein, triglycerides, urate, albumin, calcium, creatinine, glucose, phosphorous, potassium, urea and sodium. Number of participants with clinical chemistry parameters of potential clinical concern are presented.|Up to 11 weeks|Safety Population.|||Participants|||Count of Participants
2532149|NCT03315559|Secondary|Number of Participants With Hematology Parameters of Potential Clinical Concern|Hematology parameters included basophils, eosinophils, erythrocytes, monocytes, hematocrit, hemoglobin, lymphocytes, neutrophil count, platelet count and white blood cells. Number of participants with hematology parameters of potential clinical concern are presented.|Up to 11 weeks|Safety Population.|||Participants|||Count of Participants
2532189|NCT03314519|Secondary|Timing to Detect Lung Collapse|Time point from evaluation of lung collapse by each test to time point of grading lung collapse by gold standard( visual grading of lung collapse by surgeon)|30 minutes||||minutes||Full Range|Median
2532150|NCT03315559|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product (MP), whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia.|Up to 11 weeks|Safety Population.|||Participants|||Count of Participants
2532151|NCT03315559|Secondary|Oral Absolute Bioavailability (F) for Treatment Period 2|Absolute bioavailability (F) was estimated for the oral doses for each participant and is reported. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 168 h post-dose|PK Population.|||Fraction of drug||Geometric Coefficient of Variation|Geometric Mean
2532152|NCT03315559|Secondary|Inhaled Absolute Bioavailability (F) for Treatment Period 1|Absolute bioavailability (F) was estimated for the inhaled doses for each participant and is reported. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion|PK Population.|||Fraction of drug||Geometric Coefficient of Variation|Geometric Mean
2532153|NCT03315559|Secondary|Clearance of Parent [14C]-GSK2269557 After IV Dose Only in Plasma|Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature [14C]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS.|Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion|PK Population. Only those participants available at the indicated time points were analyzed.|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2532154|NCT03315559|Secondary|Volume of Distribution of Parent [14C]-GSK2269557 After IV Dose Only in Plasma|Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature [14C]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS.|Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion|PK Population. Only those participants available at the specified time points were analyzed.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2532155|NCT03315559|Secondary|t1/2 of [14C]-GSK2269557 in Plasma for Treatment Period 2|Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature [14C]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 168 h post-dose|PK Population. Only those participants available at the indicated time points were analyzed.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2532156|NCT03315559|Secondary|t1/2 of Parent GSK2269557 and [14C]-GSK2269557 in Plasma for Treatment Period 1|Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature [14C]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS, whereas GSK2269557 describes the parent GSK2269557 concentration derived via LC/MS. Only those participants available at the indicated time points were analyzed represented by n=X in the category titles.|Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion|PK Population.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2532157|NCT03315559|Secondary|Tmax of [14C]-GSK2269557 in Plasma for Treatment Period 2|Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature [14C]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 168 h post-dose|PK Population.|||Hours||Full Range|Median
2532158|NCT03315559|Secondary|Tmax of Parent GSK2269557 and [14C]-GSK2269557 in Plasma for Treatment Period 1|Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature [14C]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS, whereas GSK2269557 describes the parent GSK2269557 concentration derived via LC/MS.|Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion|PK Population.|||Hours||Full Range|Median
2532159|NCT03315559|Secondary|Cmax of [14C]-GSK2269557 in Plasma for Treatment Period 2|Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature [14C]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 168 h post-dose|PK Population.|||Picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532160|NCT03315559|Secondary|Cmax of Parent GSK2269557 and [14C]-GSK2269557 in Plasma for Treatment Period 1|Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature [14C]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS, whereas GSK2269557 describes the parent GSK2269557 concentration derived via LC/MS.|Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion|PK Population.|||Picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532192|NCT03314233|Secondary|Proportion of Infants Who Require Extracorporeal Membrane Oxygenation (ECMO) Treatment|Proportion of infants who require ECMO treatment in first 7 days of life|7 days of life|1 of the 20 infants randomized to the intervention was diagnosis with a second major anomaly postnatally and was not included in the secondary outcome results.|||Participants|||Count of Participants
2532161|NCT03315559|Secondary|AUC (0 to Inf) and AUC (0 to t) of [14C]-GSK2269557 in Plasma for Treatment Period 2|Blood samples were collected at indicated time points for pharmacokinetic analysis. Only those participants with data available at the specified time points were analyzed represented by n=X in the category titles. For measured concentrations of GSK2269557 in blood plasma, the nomenclature [14C]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 168 h post-dose|PK Population.|||Hour*picogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532162|NCT03315559|Secondary|AUC (0 to Inf) and AUC (0 to t) of Parent GSK2269557 and [14C]-GSK2269557 in Plasma for Treatment Period 1|Blood samples were collected at indicated time points for pharmacokinetic analysis. For measured concentrations of GSK2269557 in blood plasma, the nomenclature [14C]-GSK2269557 describes the parent GSK2269557 concentration derived via analysis by LC+AMS, whereas GSK2269557 describes the parent GSK2269557 concentration derived via LC/MS. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion|PK Population.|||Hour*picogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532163|NCT03315559|Primary|Urinary and Fecal Cumulative Excretion as a Percentage of the Total Radioactive Dose Administered Over Time for Treatment Period 2|Urine samples and fecal samples were collected to measure total radiolabeled drug-related material excreted in urine and feces respectively. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|Up to 336 hours|PK Population.|||Percentage of dose excreted||Standard Deviation|Mean
2532164|NCT03315559|Primary|Urinary and Faecal Cumulative Excretion as a Percentage of the Total Radioactive Dose Administered Over Time for Treatment Period 1|Urine samples and fecal samples were collected to measure total radiolabeled drug-related material excreted in urine and feces respectively.|Up to 168 hours|PK Population.|||Percentage of dose excreted||Standard Deviation|Mean
2532165|NCT03315559|Primary|Terminal Phase Half-life (t1/2) of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 2|Blood samples were collected at indicated time points for pharmacokinetic analysis. NA indicates that data is not available as single participant was analyzed.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 168 h post-dose|PK Population. Only those participants available at the indicated time points were analyzed.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2532166|NCT03315559|Primary|Terminal Phase Half-life (t1/2) of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 1|Blood samples were collected at indicated time points for pharmacokinetic analysis.|Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion|PK Population. Only those participants available at the indicated time points were analyzed.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2532167|NCT03315559|Primary|Tmax of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 2|Blood samples were collected at indicated time points for pharmacokinetic analysis.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 168 h post-dose|PK Population.|||Hours||Full Range|Median
2532168|NCT03315559|Primary|Time of Occurrence of Cmax (Tmax) of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 1|Blood samples were collected at indicated time points for pharmacokinetic analysis.|Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion|PK Population.|||Hours||Full Range|Median
2532169|NCT03315559|Primary|Cmax of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 2|Blood samples were collected at indicated time points for pharmacokinetic analysis.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 168 h post-dose|PK Population.|||Picogram Equivalent per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532170|NCT03315559|Primary|Maximum Observed Concentration (Cmax) of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 1|Blood samples were collected at indicated time points for pharmacokinetic analysis.|Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion|PK Population.|||Picogram Equivalent per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532171|NCT03315559|Primary|AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (0 to Inf) and AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (0 to t) of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 2|Blood samples were collected at indicated time points for pharmacokinetic analysis. Only those participants available at the specified time points were analyzed represented by n=X in the category titles. NA indicates that data is not available as single participant was analyzed.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96 and 168 h post-dose|PK Population.|||Hour*picogram Equivalent per millilitre||Geometric Coefficient of Variation|Geometric Mean
2532172|NCT03315559|Primary|Area Under Concentration-time Curve (AUC) From Time 0 (Pre-dose) to Infinite Time (0 to Inf) and AUC From Time 0 (Pre-dose) to Last Time of Quantifiable Concentration (0 to t) of Total Drug-related Material (Radioactivity) in Plasma for Treatment Period 1|Blood samples were collected at indicated time points for pharmacokinetic analysis. Pharmacokinetic (PK) Population comprised of participants in the APE Population who received at least one dose of study treatment and for whom a PK sample was obtained and analyzed. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|Pre-dose and at 0 hour (post inhalation and pre-IV infusion), at the end of infusion and at 0.33, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours after the start of infusion|PK Population.|||Hour*picogram Equivalent per millilitre||Geometric Coefficient of Variation|Geometric Mean
2532190|NCT03314519|Primary|Number of Patients of Lung Collapse in Ultrasonography and Fiberoptic Bronchoscopy|Compare number of patients with lung collapse detected by ultrasonography and fiberoptic bronchoscopy in patient with double lumen tube by report as specificity and sensitivity of detection of lung collapse by compare to visual grading of lung collapse by surgeon|30 minutes||||Participants|||Count of Participants
2532173|NCT03315286|Secondary|Quantification of Melanoma Skin Cancers After Using the UV Sensor vs. Control Group|Clinical counting of new non melanoma skin cancers at 3 month intervals for a total duration of 6 months. Patient's melanoma skin cancers were counted at baseline (0 months), 3 months and 6 months. The number of melanoma skin cancers at each time point is reported.|6 months|We are posting the results of patients without a transplant (97). Out of the 97 subjects, in the device group, 49 subjects completed the study. 1 subject was removed for protocol violation. In the control group, 43 subjects completed the study, 3 subjects were lost to follow up and 1 subject was removed for protocol violation.|||lesions|||Number
2532174|NCT03315286|Secondary|Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Ability to Participate in Social Roles and Activities|"PROMIS (Patient-Reported Outcomes Measurement Information System) surveys will be given to patients at at baseline (0 months), 3 months and 6 month . Specifically we will include questions about anxiety, depression, and ability to participate in social roles and activities. The surveys will be scored on a scale of 1 to 5. 1 indicates never, 5 indicates always. An example of a question would be I felt fearful and the patient would score this question on a scale of 1-5 as indicated above. The results are scored using item-level calibrations via HealthMeasures.net Scoring Service. The total raw score (aggregate of the scores) is rescaled into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10."|Baseline, 3 months and 6 months. data at baseline and 6 months will be reported||||units on a scale||Full Range|Mean
2532175|NCT03315286|Secondary|Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Anxiety|"PROMIS (Patient-Reported Outcomes Measurement Information System) surveys will be given to patients at at baseline (0 months), 3 months and 6 month . Specifically we will include questions about anxiety, depression, and ability to participate in social roles and activities. The surveys will be scored on a scale of 1 to 5. 1 indicates never, 5 indicates always. An example of a question would be I felt fearful and the patient would score this question on a scale of 1-5 as indicated above. The results are scored using item-level calibrations via HealthMeasures.net Scoring Service. The total raw score (aggregate of the scores) is rescaled into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10."|Baseline, 3 months and 6 months. data at baseline and 6 months will be reported||||units on a scale||Full Range|Mean
2532176|NCT03315286|Secondary|Impact of UV Sensor (SHADE) on Patient's Quality of Life as Measured by PROMIS - Depression|"PROMIS (Patient-Reported Outcomes Measurement Information System) surveys will be given to patients at at baseline (0 months), 3 months and 6 month . Specifically we will include questions about anxiety, depression, and ability to participate in social roles and activities. The surveys will be scored on a scale of 1 to 5. 1 indicates never, 5 indicates always. An example of a question would be I felt fearful and the patient would score this question on a scale of 1-5 as indicated above. The results are scored using item-level calibrations via HealthMeasures.net Scoring Service. The total raw score (aggregate of the scores) is rescaled into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10."|Baseline, 3 months and 6 months. data at baseline and 6 months will be reported||||units on a scale||Full Range|Mean
2532177|NCT03315286|Secondary|Quantification of Non Melanoma Skin Cancers After Using the UV Sensor vs. Control Group|Clinical counting of new non melanoma skin cancers at 3 month intervals for a total duration of 6 months. Patient's non melanoma skin cancers were counted at baseline (0 months), 3 months and 6 months. The average number of non melanoma skin cancers at 6 months is only reported.|6 months|We are posting the results of patients without a transplant (97). Out of the 97 subjects, in the device group, 49 subjects completed the study. 1 subject was removed for protocol violation. In the control group, 43 subjects completed the study, 3 subjects were lost to follow up and 1 subject was removed for protocol violation.|||lesions||Full Range|Mean
2532178|NCT03315286|Primary|Quantification of Actinic Keratosis Using the UV Sensor vs. Control Group|Clinical counting of new actinic keratosis at 3 month intervals for a total duration of 6 months. Patient's actinic keratosis were counted at baseline (0 months), 3 months and 6 months. The average number of actinic keratosis at 6 months is only reported.|6 months|We are posting the results of patients without a transplant (97). Out of the 97 subjects, in the device group, 49 subjects completed the study. 1 subject was removed for protocol violation. In the control group, 43 subjects completed the study, 3 subjects were lost to follow up and 1 subject was removed for protocol violation.|||lesions||Full Range|Mean
2532179|NCT03314753|Primary|Number of Participatns With Adenosine Testing|Number of participants with adenosine testing|At time of re-ablation||||Participants|||Count of Participants
2532180|NCT03314753|Primary|Number of Participants With Anti-arrhythmic Drug Use at Time of Discharge From the Re-ablation Procedure|Anti-arrhythmic drug use at time of discharge from the re-ablation procedure via medical log on AADs|Date of hospital discharge, assessed during the 36 month FU period||||Participants|||Count of Participants
2532181|NCT03314753|Primary|Number of Hospital Days for Re-ablation Procedure Form Admission to Discharge|Number of hospital days for re-ablation procedure form admission to discharge|From Date of Hospital admission until the date of hospital discharge up to 36 month FU period||||nights||Standard Deviation|Mean
2532182|NCT03314753|Primary|Re-ablation Procedure Times as Measured in the Cath Lab|Re-ablation procedure times as measured in the cath lab|At time of re-ablation||||minutes||Standard Deviation|Mean
2532183|NCT03314753|Primary|Percentage of Participants With Acute Procedural Success of Re-ablation Procedure|Summarize acute procedural success of re-ablation procedure per treatment arm|At time of re-ablation|A patient was defined as an acute success if all ablation attempts within the re-ablation procedure were reported as successful. Pulmonary Vein Isolation (PVI) was assessed minimally via documented entrance block, and where assessable exit block (electrical signal detection).|||percentage of patients with acute succes|||Number
2532184|NCT03314753|Primary|Number of Pulmonary Veins Ablation - Ablation Lesion Sets Created During Re-ablation Procedure|Description of all ablation lesion sets created during re-ablation procedure|At time of re-ablation|The number of lesion sets for each patient was counted for this objective. If a patient had multiple pulmonary veins ablated during the re-ablation procedure, each pulmonary vein was counted as a lesion set towards the patients total count.|||Pulmonary Veins ablated||Standard Deviation|Mean
2532185|NCT03314753|Primary|Number of Gaps and Location of Gaps Present in Pulmonary Vein Ablation Lesions Per Participant|Number of gaps and location of gaps present in pulmonary vein ablation lesions as seen in the cath lab / imaging|At time of re-ablation|Data were not collected; no standard documention and therfore not available in the reviewed medical files in the required detail||||||
2532193|NCT03314233|Secondary|Presence of Severe Pulmonary Hypertension|Presence of severe pulmonary hypertension on first echocardiogram|Approximately 24 hours of life|1 of the 20 infants randomized to the intervention was diagnosis with a second major anomaly postnatally and was not included in the secondary outcome results. 1 trial participant was supported with ECMO when the echocardiogram was obtained and therefore was not assessed.|||Participants|||Count of Participants
2532194|NCT03314233|Secondary|Proportion of Infants Who Require Vasopressors|Proportion of infants who require vasopressors in first 48 hours of life|First 48 hours of life|1 of the 20 infants randomized to the intervention was diagnosis with a second major anomaly postnatally and was not included in the secondary outcome results.|||Participants|||Count of Participants
2532195|NCT03314233|Secondary|Oxygenation Index (OI)|Oxygenation index [OI] with first obtained blood gas|First obtained blood gas|1 of the 20 infants randomized to the intervention was diagnosis with a second major anomaly postnatally and was not included in the secondary outcome results.|||oxygenation index||Inter-Quartile Range|Median
2532196|NCT03314233|Secondary|Mean Partial Pressure of O2 in Arterial Blood (PaO2)|Arterial PaO2 on first blood gas|Approximately 1 hour of life|1 of the 20 infants randomized to the intervention was diagnosis with a second major anomaly postnatally and was not included in the secondary outcome results.|||PaO2||Inter-Quartile Range|Median
2532197|NCT03314233|Secondary|Mean Arterial Potential of Hydrogen (pH) in Arterial Blood|Arterial pH on first blood gas|Approximately 1 hour of life|1 of the 20 infants randomized to the intervention was diagnosis with a second major anomaly postnatally and was not included in the secondary outcome results.|||pH||Standard Deviation|Mean
2532198|NCT03314233|Primary|Proportion of Infants Who Are Intubated Prior to Umbilical Cord Clamping|Infants who are intubated and have ventilation initiated prior to umbilical cord clamping|3 minutes of life||||Participants|||Count of Participants
2532199|NCT03313037|Secondary|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post Any Vaccination: 7 Additional Serotypes in 20vPnC|GMFR for 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) from before Vaccination 1 to one month after either Vaccination 1 (20vPnC) or Vaccination 2 (PPSV23) were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.|before Vaccination 1 to 1 month after Vaccination 1 for 20vPnC followed by saline reporting group; before Vaccination 1 to 1 month after Vaccination 2 for 13vPnC followed by PPSV23 reporting group|EIP: participants with no protocol deviations, received assigned vaccine, blood drawn within 27 to 49 days after Vaccination 1 or 2, had OPA titres for at least 1 serotype either 1 month after Vaccination 1 or 2. ‘Number analyzed’ = Number of Participants with non-missing OPA results at both time points at specified row.|||fold rise||95% Confidence Interval|Geometric Mean
2532200|NCT03313037|Secondary|Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination 1 to 1 Month Post-Vaccination 1: 13 Common Serotypes in 13vPnC|GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before Vaccination 1 to one month after Vaccination 1 were calculated as the mean of the difference of logarithmically transformed OPA results (after vaccination - before vaccination) and transform back to the original scale. GMFRs were calculated using data from participants with non-missing OPA results at both time points. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.|before Vaccination 1 to one month after Vaccination 1|EIP: participants with no major protocol deviations, received assigned vaccine, blood drawn within 27 to 49 days after Vaccination 1 or 2, had OPA titres for at least 1 serotype either 1 month after Vaccination 1 or 2. ‘Number analyzed’ = Number of participants with non-missing OPA results at both time points at specified rows.|||fold rise||95% Confidence Interval|Geometric Mean
2532201|NCT03313037|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Any Vaccination: 7 Additional Serotypes in 20vPnC|Antibody-mediated serum OPA against the 7 additional pneumococcal serotypes (8, 10A, 11A, 12F, 15B, 22F, 33F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.|1 month after Vaccination 1 for 20vPnC followed by saline reporting group; 1 month after Vaccination 2 for 13vPnC followed by PPSV23 reporting group|EIP: participants with no major protocol deviations, received assigned vaccine, blood drawn within 27 to 49 days after Vaccination 1 or 2, had OPA titres for at least 1 serotype either 1 month after Vaccination 1 or 2. ‘Number analyzed’ = Participants evaluable for this outcome measure at specified rows.|||Titer (1/dilution)||95% Confidence Interval|Geometric Mean
2532202|NCT03313037|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titres (GMTs) 1 Month After Vaccination 1: 13 Common Serotypes in 13vPnC|Antibody-mediated serum OPA against the 13 common pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were measured using a pneumococcal OPA assay. Results were expressed as OPA GMTs. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ in the analysis.|1 month after Vaccination 1|EIP: participants with no major protocol deviations, received assigned vaccine, blood drawn within 27 to 49 days after Vaccination 1 or 2, had OPA titres for at least 1 serotype either 1 month after Vaccination 1 or 2. ‘Number analyzed’ = Participants evaluable for this outcome measure at specified rows.|||Titer (1/dilution)||95% Confidence Interval|Geometric Mean
2532203|NCT03313037|Primary|Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 12 Months After Vaccination 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported.|within 12 months after Vaccination 1 (up to 378 days)|Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC.|||percentage of participants||95% Confidence Interval|Number
2532204|NCT03313037|Primary|Percentage of Participants With Serious Adverse Events (SAEs) or Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. Percentage of participants with either SAE or NDCMCs during the specified duration are reported.|within 6 months after Vaccination 1 (up to 196 days)|Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC.|||percentage of participants||95% Confidence Interval|Number
2532205|NCT03313037|Primary|Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination 1|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|within 1 month after Vaccination 1 (up to 35 days)|Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC.|||percentage of participants||95% Confidence Interval|Number
2532206|NCT03313037|Primary|Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1|Systemic events included fever, fatigue, headache, muscle pain and joint pain, recorded by participants in an e-diary. Fever was categorized as: >=38.0 degrees Celsius (C), >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Fatigue, headache, muscle pain and joint pain were graded as mild: no interference with activity, moderate: some interference with activity and severe: prevents daily routine activity.|within 7 days after Vaccination 1|Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC. Here “Overall number of participants analyzed” signifies participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2532207|NCT03313037|Primary|Percentage of Participants With Local Reactions Within 10 Days After Vaccination 1|Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (>) 2.0 to 5.0 centimeter (cm), moderate: 5.5 to 10.0 cm and severe: greater than or equal to (>=) 10.5 cm. Pain was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity.|within 10 days after Vaccination 1|Safety analysis set included all participants who had received 1 dose of 20vPnC or 13vPnC. Here “Overall number of participants analyzed” signifies participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2532208|NCT03312933|Primary|The Presence and Severity of Secondary Site Pain|The primary outcome was the presence of secondary site pain that developed or worsened during CAM walker boot wear. Surveys inquired about the presence of secondary site pain, defined as lower back, ipsilateral hip, contralateral hip, ipsilateral knee, contralateral knee, contralateral ankle, and contralateral foot. Severity of pain was assessed using a 100-point visual analog scale (VAS), with zero indicating no pain and 100 representing the worst pain imaginable.|At the time of transitioning out of the boot||||Participants|||Count of Participants
2532209|NCT03312543|Secondary|Lack of Radiance - Change From Baseline to Week 24|3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.|Baseline to Week 24|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532210|NCT03312543|Secondary|Lack of Radiance - Change From Baseline to Week 12|3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.|Baseline to Week 12|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532211|NCT03312543|Secondary|Lack of Radiance - Change From Baseline to Week 4|3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.|Baseline to Week 4|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532212|NCT03312543|Secondary|Lack of Radiance - Change From Baseline to Week 1|3 Expert Graders evaluated lack of radiance on a 0-9 scale, where 0 = none (extremely radiant) to 9 = severe dullness/matte appearance. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.|Baseline to Week 1|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532213|NCT03312543|Secondary|Sallowness/Yellowing - Change From Baseline to Week 24|3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.|Baseline to Week 24|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532214|NCT03312543|Secondary|Sallowness/Yellowing - Change From Baseline to Week 12|3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.|Baseline to Week 12|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532215|NCT03312543|Secondary|Sallowness/Yellowing - Change From Baseline to Week 4|3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.|Baseline to Week 4|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532216|NCT03312543|Secondary|Sallowness/Yellowing - Change From Baseline to Week 1|3 Expert Graders evaluated sallowness/yellowing on a 0-9 scale, where 0 = none to 9 = severe. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.|Baseline to Week 1|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532217|NCT03312543|Secondary|Mottled Hyperpigmentation - Change From Baseline to Week 24|3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.|Baseline to Week 24|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532218|NCT03312543|Secondary|Mottled Hyperpigmentation - Change From Baseline to Week 12|3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.|Baseline to Week 12|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532219|NCT03312543|Secondary|Mottled Hyperpigmentation - Change From Baseline to Week 4|3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.|Baseline to Week 4|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532220|NCT03312543|Secondary|Mottled Hyperpigmentation - Change From Baseline to Week 1|3 Expert Graders evaluated mottled hyperpigmentation on a 0-9 scale, where 0 = none (perfectly even tone) to 9 = severe mottled hyperpigmentation. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.|Baseline to Week 1|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532221|NCT03312543|Secondary|Uneven Skin Tone - Change From Baseline to Week 24|3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.|Baseline to Week 24|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532222|NCT03312543|Secondary|Uneven Skin Tone - Change From Baseline to Week 12|3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.|Baseline to Week 12|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532223|NCT03312543|Secondary|Uneven Skin Tone - Change From Baseline to Week 4|3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.|Baseline to Week 4|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532224|NCT03312543|Secondary|Uneven Skin Tone - Change From Baseline to Week 1|3 Expert Graders evaluated uneven skin tone on a 0-9 scale, where 0 = perfectly uniform/even skin tone to 9 = pronounced/severe uneven skin tone. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.|Baseline to Week 1|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532225|NCT03312543|Secondary|Surface Roughness - Change From Baseline to Week 24|3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.|Week 24|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532226|NCT03312543|Secondary|Surface Roughness - Change From Baseline to Week 12|3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.|Baseline to Week 12|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532227|NCT03312543|Secondary|Surface Roughness - Change From Baseline to Week 4|3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.|Baseline to Week 4|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532228|NCT03312543|Secondary|Surface Roughness - Change From Baseline to Week 1|3 Expert Graders evaluated surface roughness on a 0-9 scale, where 0 = perfectly smooth to 9 = severe roughness (visible and tactile). The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.|Baseline to Week 1|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532229|NCT03312543|Secondary|Periorbital Wrinkles - Change From Baseline to Week 24|3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.|Baseline to Week 24|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532230|NCT03312543|Secondary|Periorbital Wrinkles - Change From Baseline to Week 12|3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.|Baseline to Week 12|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532231|NCT03312543|Secondary|Periorbital Wrinkles - Change From Baseline to Week 4|3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.|Baseline to Week 4|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532232|NCT03312543|Secondary|Periorbital Wrinkles - Change From Baseline to Week 1|3 Expert Graders evaluated periorbital wrinkles on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.|Baseline to Week 1|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532233|NCT03312543|Secondary|Fine Lines - Change From Baseline to Week 24|3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.|Baseline to Week 24|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532234|NCT03312543|Secondary|Fine Lines - Change From Baseline to Week 12|3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.|Baseline to Week 12|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2532235|NCT03312543|Secondary|Fine Lines - Change From Baseline to Week 4|3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.|Baseline to Week 4|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a Scale||Standard Deviation|Mean
2542049|NCT03011099|Primary|Change in Walking Endurance as Assessed by the 6 Minute Walk Test|The 6 Minute Walk Test assesses the distance walked in 6 minutes.|baseline, week 4||||feet||Standard Deviation|Mean
2532236|NCT03312543|Secondary|Fine Lines - Change From Baseline to Week 1|3 Expert Graders evaluated fine lines on a 1-9 scale, where 1 = mildest fine lines to 9 = most severe fine lines. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.|1 week|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a scale||Standard Deviation|Mean
2532237|NCT03312543|Secondary|Global Wrinkling - Change From Baseline to Week 24|3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 24. Change from baseline was calculated as Baseline mean minus Week 24 mean so a positive score indicates improvement.|Baseline to Week 24|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a scale||Standard Deviation|Mean
2532238|NCT03312543|Secondary|Global Wrinkling - Change From Baseline to Week 4|3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 4. Change from baseline was calculated as Baseline mean minus Week 4 mean so a positive score indicates improvement.|Baseline to Week 4|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a scale||Standard Deviation|Mean
2532239|NCT03312543|Secondary|Global Wrinkling - Change From Baseline to Week 1|3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 1. Change from baseline was calculated as Baseline mean minus Week 1 mean so a positive score indicates improvement.|Baseline to Week 1|Intent-to-treat population was used, including all subjects with data for this time point. The number analyzed may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a scale||Standard Deviation|Mean
2532240|NCT03312543|Primary|Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 3|Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 3 were calculated individually.|Baseline to Week 12|Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. 5 subjects withdrew prior to baseline and there was no post-baseline data to carry forward for an additional 3 subjects.|||Units on a scale.||Standard Deviation|Mean
2532241|NCT03312543|Primary|Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 2|Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 2 were calculated individually.|Baseline to Week 12|Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. 5 subjects withdrew prior to baseline and there was no post-baseline data to carry forward for an additional 3 subjects.|||Units on a scale.||Standard Deviation|Mean
2532242|NCT03312543|Primary|Global Wrinkling - Change From Baseline to Week 12, Individual Expert Grader Scores - Expert Grader 1|Each Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement. Scores for Expert Grader 1 were calculated individually.|Baseline to Week 12|Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. 5 subjects withdrew prior to baseline and there was no post-baseline data to carry forward for an additional 3 subjects.|||Units on a scale.||Standard Deviation|Mean
2532243|NCT03312543|Primary|Global Wrinkling - Change From Baseline to Week 12, Averaged Expert Grader Scores|3 Expert Graders evaluated global wrinkling on a 1-9 scale, where 1 = mildest wrinkles to 9 = most severe wrinkles. The 3 Expert Grader scores were averaged for Baseline and for Week 12. Change from baseline was calculated as Baseline mean minus Week 12 mean so a positive score indicates improvement.|Baseline to Week 12|Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. 5 subjects withdrew prior to baseline and there was no post-baseline data to carry forward for an additional 3 subjects.|||Units on a scale||Standard Deviation|Mean
2532244|NCT03312517|Primary|Auditory Awakening Threshold|Subjects will be awakened during the night to auditory awakening tones.|2.5 hours post-dose of each Study Drug administration|We compared the odds of individuals sleeping through a 85-db stimulus in each condition. A generalized linear mixed model was used to estimate binary outcomes|||decibels (db)||Standard Deviation|Mean
2532245|NCT03312348|Primary|Number of Participants for Which Thermal Imaging Technique Correctly Identified Area of Focus for a Limping Child|Number of Participants for Which Thermal Imaging Technique Correctly Identified Area of Focus for a Limping Child - 25|10 minutes||||Participants|||Count of Participants
2532259|NCT03311841|Primary|Maximum Plasma Concentration (Cmax) Post-dose Period 1|Cmax is the peak plasma concentration of study drug after administration. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose|All participants who were compliant with the study procedure and had available data. Per protocol, participants were excluded from this analysis of Cmax for the following reasons: non-compliance with the protocol or high pre-dose concentrations.|||pg/mL||95% Confidence Interval|Geometric Mean
2532503|NCT03304119|Secondary|Measure of Patellar Tilt|Patellar Tilt (yes or no), based on a patient IRM. Unit in degre.|4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable. Unit in degre|Patients with IRM available.|||degre||Inter-Quartile Range|Median
2532246|NCT03311841|Secondary|Effect of Rifampin on Vz/F Post-dose Period 2|To evaluate the effect of a single oral dose of rifampin on the Vz/F of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. Vz/F is the distribution of study drug between the plasma and the rest of the body after the dose. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2.|Microdose cocktail: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose|All participants who received rifampin, were compliant with the study procedure and had available data. Per protocol, participants were excluded from this analysis of Vz/F for the following reasons: non-compliance with the protocol or high pre-dose concentrations. Per protocol, end-stage renal disease participants did not receive rifampin.|||liters||Geometric Coefficient of Variation|Geometric Least Squares Mean
2532247|NCT03311841|Secondary|Effect of Rifampin on CL/F Post-dose Period 2|To evaluate the effect of a single oral dose of rifampin on the CL/F of midazolam, dabigatran, pitavastatin, atorvastatin, and rosuvatatin. CL/F is the rate at which study drug was removed from the body. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2.|Microdose cocktail: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose|All participants who received rifampin, were compliant with the study procedure and had available data. Per protocol, participants were excluded from this analysis of CL/F for the following reasons: non-compliance with the protocol or high pre-dose concentrations. Per protocol, end-stage renal disease participants did not receive rifampin.|||liters/hour||Geometric Coefficient of Variation|Geometric Least Squares Mean
2532248|NCT03311841|Secondary|Effect of Rifampin on t1/2 Post-dose Period 2|To evaluate the effect of a single oral dose of rifampin on the t1/2 of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. T1/2 is the elimination half-life of study drug. T1/2 is the time it takes for half of the study drug in the blood plasma to dissipate. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2.|Microdose cocktail: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose|All participants who received rifampin, were compliant with the study procedure and had available data. Per protocol, participants were excluded from this analysis of t1/2 for the following reasons: non-compliance with the protocol or high pre-dose concentrations. Per protocol, end-stage renal disease participants did not receive rifampin.|||hours||Geometric Coefficient of Variation|Geometric Least Squares Mean
2532249|NCT03311841|Secondary|Effect of Rifampin on Tmax Post-dose Period 2|To evaluate the effect of a single oral dose of rifampin on the Tmax of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. Tmax is the amount of time to reach maximum (peak) plasma drug concentration following drug administration. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2.|Microdose cocktail: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose|All participants who received rifampin, were compliant with the study procedure and had available data. Per protocol, participants were excluded from this analysis of Tmax for the following reasons: non-compliance with the protocol or high pre-dose concentrations. Per protocol, end-stage renal disease participants did not receive rifampin.|||hours||Full Range|Median
2532250|NCT03311841|Secondary|Effect of Rifampin on C24 Post-dose Period 2|To evaluate the effect of a single oral dose of rifampin on the C24 of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. C24 is a measure of the plasma study drug concentration 24 hours post-dose. C24 is reported as median (minimum and maximum) in severe renal impairment arm due to zero values. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2.|24 hours post-dose|All participants who received rifampin, were compliant with the study procedure and had available data. Per protocol, participants were excluded from this analysis of C24 for the following reasons: non-compliance with the protocol or high pre-dose concentrations. Per protocol, end-stage renal disease participants did not receive rifampin.|||pg/mL||95% Confidence Interval|Geometric Least Squares Mean
2532251|NCT03311841|Secondary|Effect of Rifampin on Cmax Post-dose Period 2|To evaluate the effect of a single oral dose of rifampin on the Cmax of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. Cmax is the peak plasma concentration of study drug after administration. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2.|Microdose cocktail: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose|All participants who received rifampin, were compliant with the study procedure and had available data. Per protocol, participants were excluded from this analysis of Cmax for the following reasons: non-compliance with the protocol or high pre-dose concentrations. Per protocol, end-stage renal disease participants did not receive rifampin.|||pg/mL||95% Confidence Interval|Geometric Least Squares Mean
2532252|NCT03311841|Secondary|Effect of Rifampin on AUC0-last Post-dose Period 2|To evaluate the effect of a single oral dose of rifampin on the AUC0-last of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. AUC0-last is the area under the plasma concentration-time curve from time zero to time of last measurable concentration. It is a measure of the amount of study drug in the blood plasma from pre-dose until the last measurable concentration of study drug could be determined. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2.|Microdose cocktail: 0 hour (pre-dose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose|All participants who received rifampin, were compliant with the study procedure and had available data. Per protocol, participants were excluded from this analysis of AUC0-last for the following reasons: non-compliance with the protocol or high pre-dose concentrations. Per protocol, end-stage renal disease participants did not receive rifampin.|||pg*hr/mL||95% Confidence Interval|Geometric Least Squares Mean
2532253|NCT03311841|Secondary|Effect of Rifampin on AUC0-24 Post-dose Period 2|To evaluate the effect of a single oral dose of rifampin on the AUC0-24 of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post-dose. This is a measure of the average amount of study drug in the blood plasma over a period of 24 hours after the dose. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include end-stage renal disease participants as they did not receive rifampin during Period 2.|Microdose cocktail: 0 hour (pre-dose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose; rifampin: 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose|All participants who received rifampin, were compliant with the study procedure and had available data. Per protocol, participants were excluded from this analysis of AUC0-24 for the following reasons: non-compliance with the protocol or high pre-dose concentrations. Per protocol, end-stage renal disease participants did not receive rifampin.|||pg*hr/mL||95% Confidence Interval|Geometric Least Squares Mean
2532254|NCT03311841|Primary|Apparent Volume of Distribution During the Terminal Phase (Vz/F) Post-dose Period 1|Vz/F is the distribution of study drug between the plasma and the rest of the body after the dose. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis. Vz/F was to be calculated for the parent plasma analytes only, midazolam, dabigatran, pitavastatin, atorvastatin, and rosuvastatin.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose|All participants who were compliant with the study procedure and had available data. Per protocol, participants were excluded from this analysis of Vz/F for the following reasons: non-compliance with the protocol or high pre-dose concentrations.|||liters||Geometric Coefficient of Variation|Geometric Mean
2532255|NCT03311841|Primary|Apparent Clearance After Extravascular Administration (CL/F) Post-dose Period 1|CL/F is the rate at which study drug was removed from the body. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis. CL/F was to be calculated for the parent plasma analytes only, midazolam, dabigatran, pitavastatin, atorvastatin, and rosuvastatin.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose|All participants who were compliant with the study procedure and had available data. Per protocol, participants were excluded from this analysis of CL/F for the following reasons: non-compliance with the protocol or high pre-dose concentrations.|||liters/hour||Geometric Coefficient of Variation|Geometric Mean
2532256|NCT03311841|Primary|Apparent Plasma Terminal Half-life (t1/2) Post-dose Period 1|T1/2 is the elimination half-life of study drug. T1/2 is the time it takes for half of the study drug in the blood plasma to dissipate. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose|All participants who were compliant with the study procedure and had available data. Per protocol, participants were excluded from this analysis of t1/2 for the following reasons: non-compliance with the protocol or high pre-dose concentrations.|||hours||Geometric Coefficient of Variation|Geometric Mean
2532257|NCT03311841|Primary|Time to Maximum Plasma Concentration (Tmax) Post-dose Period 1|Tmax is the amount of time to reach maximum (peak) plasma drug concentration following drug administration. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis.|0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose|All participants who were compliant with the study procedure and had available data. Per protocol, participants were excluded from this analysis of Tmax for the following reasons: non-compliance with the protocol or high pre-dose concentrations.|||hours||95% Confidence Interval|Geometric Mean
2532258|NCT03311841|Primary|Plasma Concentration at 24 Hours (C24) Post-dose Period 1|C24hr is a measure of the plasma study drug concentration 24 hours post-dose. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis.|24 hours post-dose|All participants who were compliant with the study procedure and had available data. Per protocol, participants were excluded from this analysis of C24 for the following reasons: non-compliance with the protocol or high pre-dose concentrations.|||pg/mL||95% Confidence Interval|Geometric Mean
2542050|NCT03011099|Primary|Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test|The 10 Meter Walk Test assesses the time taken to walk 10 meters.|baseline, week 4||||seconds||Standard Deviation|Mean
2532260|NCT03311841|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Last (AUC0-last) Post-dose Period 1|AUC0-last is the area under the plasma concentration-time curve from time zero to time of last measurable concentration. This is a measure of the amount of study drug in the blood plasma from pre-dose until the last measurable concentration of study drug could be determined. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis.|0 hour (pre-dose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose|All participants who were compliant with the study procedure and had available data. Per protocol, participants were excluded from this analysis of AUC0-last for the following reasons: non-compliance with the protocol or high pre-dose concentrations.|||pg*hr/mL||95% Confidence Interval|Geometric Mean
2532261|NCT03311841|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) Post-dose Period 1|AUC0-24 is the area under the plasma concentration-time curve from time 0 to 24 hours post-dose. This is a measure of the average amount of study drug in the blood plasma over a period of 24 hours after the dose. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease requiring hemodialysis.|0 hour (pre-dose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose|All participants who were compliant with the study procedure and had available data. Per protocol, participants were excluded from this analysis of AUC0-24 for the following reasons: non-compliance with the protocol or high pre-dose concentrations.|||pg*hr/mL||95% Confidence Interval|Geometric Mean
2532262|NCT03311841|Primary|Effect of Rifampin on AUC0-inf Post-dose Period 2|To evaluate the effect of a single oral dose of rifampin on the AUC0-inf of midazolam, dabigatran, pitavastatin, pitavastatin lactone, atorvastatin, ortho-hydroxyatorvastatin, and rosuvatatin. AUC0-inf is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail and rifampin in healthy participants and participants with renal impairment. As pre-specified in the protocol, this outcome measure does not include data from the end-stage renal disease participants as they did not receive rifampin during Period 2.|Microdose cocktail: 0 hour (pre-dose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose; rifampin: 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 24 hours post-dose|All participants who received rifampin, were compliant with the study procedure and had available data. Per protocol, participants were excluded from this analysis of AUC0-inf for the following reasons: non-compliance with the protocol or high pre-dose concentrations. Per protocol, end-stage renal disease participants did not receive rifampin.|||pg*hr/mL||95% Confidence Interval|Geometric Least Squares Mean
2532263|NCT03311841|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) Post-dose Period 1|AUC0-inf is the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time. Plasma pharmacokinetic data presented in the table below are following the administration of a single oral dose of a microdose cocktail in healthy participants, participants with renal impairment, and 24 hours prior to hemodialysis in participants with end-stage renal disease (ESRD) requiring hemodialysis.|0 hour (pre-dose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, and 72 hours post-dose|All participants who were compliant with the study procedure and had available data. Per protocol, participants were excluded from this analysis of AUC0-inf for the following reasons: non-compliance with the protocol or high pre-dose concentrations.|||pg*hr/mL||95% Confidence Interval|Geometric Least Squares Mean
2532264|NCT03311659|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.|From Day 1 to Day 31|Analysis was performed on TVC which included all subjects with the study vaccine administration documented.|||Participants|||Count of Participants
2532265|NCT03311659|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|Any unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.|During the 31-day (Day 1-31) follow-up period after vaccination|Analysis was performed on TVC which included all subjects with the study vaccine administration documented.|||Participants|||Count of Participants
2532266|NCT03311659|Secondary|Number of Subjects With Large Swelling Reactions.|Large injection site reaction for subjects < 6 years of age defined as a swelling with a diameter of > 50 mm and for subjects ≥ 6 years of age swelling with a diameter of > 100 mm, noticeable diffuse swelling or noticeable increase in limb circumference. Any = Occurence of any large swelling regardless of its intensity grade and relationship to the study vaccination.|During the 4-day (Day 1-4) follow-up period after vaccination.|Analysis was performed on TVC which included all subjects with the study vaccine administration and solicited symptoms documented.|||Participants|||Count of Participants
2532267|NCT03311659|Secondary|Number of Subjects Aged 6 Years and Above With Solicited General Symptoms.|Assessed solicited general symptoms were Fatigue, Gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), Headache and Fever. Any = Occurence of any general symptom regardless of its intensity grade and relationship to the study vaccination. Fever was defined as axilla temperature ≥ 38 °C.|During the 4-day (Day 1-4) follow-up period after vaccination.|Analysis was performed on subset of TVC which included subjects aged above and equal to 6 years, with the study vaccine administration documented and had solicited symptoms documented.|||Participants|||Count of Participants
2532268|NCT03311659|Secondary|Number of Subjects Aged Below 6 Years With Solicited General Symptoms.|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever. Any = Occurrence of any general symptom regardless of its intensity grade and relationship to the study vaccination. Fever was defined as temperature ≥ 38.0 degrees Celsius (°C). The location for measuring temperature was the axilla.|During the 4-day (Day 1-4) follow-up period after vaccination.|Analysis was performed on subset of TVC which included subjects aged below 6 years, with the study vaccine administration documented and had solicited symptoms documented.|||Participants|||Count of Participants
2532269|NCT03311659|Secondary|Number of Subjects With Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness, swelling. Any = Occurrence of any local symptom regardless of its intensity grade. Any redness and swelling were defined as > 0 millimeters (mm) diameter for all subjects.|During the 4-day (Day 1-4) follow-up period after vaccination.|Analysis was performed on Total Vaccinated Cohort (TVC) which included all subjects with the study vaccine administration and solicited symptoms documented.|||Participants|||Count of Participants
2532270|NCT03311659|Secondary|Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations , One Month After Vaccination.|Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in IU/mL. The cut-off for the assays were: 0.057 IU/mL for anti-D, 0.043 IU/mL for anti-T, 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN, respectively.|At Day 31|The Per Protocol (PP) Cohort for immunogenicity included all evaluable subjects who had received the dose of study vaccine, met all eligibility criteria, complied with the procedures and intervals defined in the protocol, for whom assay results were available for antibodies against at least one study vaccine antigen component.|||IU/mL||95% Confidence Interval|Geometric Mean
2532271|NCT03311659|Secondary|Number of Subjects With a Booster Response to the PT, FHA and PRN Antigens.|"Booster response to PT, FHA and PRN antigens was defined according to pre-vaccination antibody concentrations:~for subjects with pre-vaccination values below (<) the assay cut-off, post-vaccination antibody concentration ≥ 4 times the assay cut-off; and~for subjects with pre-vaccination values between the assay cut-off and <4 times the assay cut-off, post-vaccination antibody concentration ≥ 4 times the pre-vaccination antibody concentration; and for subjects with pre-vaccination antibody concentration ≥ 4 times the assay cut-off, post-vaccination antibody concentration ≥ 2 times the pre-vaccination antibody concentration.~Seronegative (S-) subjects are those who have antibody concentration less than (<) assay cut-off and seropositive (S+) subjects are those who have antibody concentration ≥ assay cut-off prior to vaccination. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti- FHA and 2.187 IU/mL for anti-PRN respectively."|At Day 31|The Per Protocol (PP) Cohort for immunogenicity included all evaluable subjects who had received the dose of study vaccine, met all eligibility criteria, complied with the procedures and intervals defined in the protocol, for whom assay results were available for antibodies against at least one study vaccine antigen component.|||Participants|||Count of Participants
2532272|NCT03311659|Secondary|Number of Subjects With a Booster Response to the Diphtheria and Tetanus Antigens|"Booster response to diphtheria (D) and tetanus (T) antigens was defined according to pre-vaccination antibody concentration:~for subjects with values <0.1 IU/ml (i.e. below the seroprotection cut-off), antibody concentrations of at least ≥0.4 IU/ml, one month after vaccination; and~for subjects with values ≥0.1 IU/ml (i.e. equal to or above the seroprotection cut-off), an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination. Seronegative (S-) subjects are those who have antibody concentration less than (<) 0.1 IU/mL and seropositive (S+) subjects are those who have antibody concentration ≥ 0.1 IU/mL prior to vaccination."|At Day 31|The Per Protocol (PP) Cohort for immunogenicity included all evaluable subjects who had received the dose of study vaccine, met all eligibility criteria, complied with the procedures and intervals defined in the protocol, for whom assay results were available for antibodies against at least one study vaccine antigen component.|||Participants|||Count of Participants
2532273|NCT03311659|Primary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN).|A seropositive subject was a subject whose antibody concentration was greater than or equal to the assay cut-off value. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN respectively.|At Day 31|The Per Protocol (PP) Cohort for immunogenicity included all evaluable subjects who had received the dose of study vaccine, met all eligibility criteria, complied with the procedures and intervals defined in the protocol, for whom assay results were available for antibodies against at least one study vaccine antigen component.|||Participants|||Count of Participants
2532274|NCT03311659|Primary|Number of Seroprotected Subjects for Anti-tetanus (Anti-T).|A seroprotected subject was a subject whose anti-T concentrations were ≥ 0.1 IU/ml. Seroprotection was assessed by ELISA method.|At Day 31|The Per Protocol (PP) Cohort for immunogenicity included all evaluable subjects who had received the dose of study vaccine, met all eligibility criteria, complied with the procedures and intervals defined in the protocol, for whom assay results were available for antibodies against at least one study vaccine antigen component.|||Participants|||Count of Participants
2532275|NCT03311659|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D).|A seroprotected subject was a subject whose anti-D concentrations were greater than or equal to (≥) 0.1 International units per milliliter (IU/ml). Seroprotection was assessed by enzyme-linked immunosorbent assay (ELISA) method. In addition, sera with ELISA concentrations <0.1 IU/ml were tested for neutralising antibodies using a Vero-cell neutralisation assay. Both the ELISA test (antibody concentrations ≥ 0.1 IU/ml) and Vero-cell test (antibody concentration ≥ 0.01 IU/ml) defined the seroprotection status for the primary endpoint.|At Day 31|The Per Protocol (PP) Cohort for immunogenicity included all evaluable subjects who had received the dose of study vaccine, met all eligibility criteria, complied with the procedures and intervals defined in the protocol, for whom assay results were available for antibodies against at least one study vaccine antigen component.|||Participants|||Count of Participants
2532276|NCT03311646|Secondary|Questionnaire of Smoking Urges|Measure of craving, Range from 10-70, Higher scores indicate greater craving. Participants complete the Questionnaire of Smoking Urges on Days 2-5 of both the NNC (baseline) and VLNC Condition. Data here are from the VLNC Condition.|Participants complete the Questionnaire of Smoking Urges on Days 2-5 of both the NNC (baseline) and VLNC Condition. Data here are from the VLNC Condition.|Results are presented for the 16 participants who completed both the NNC (baseline) and the VLNC conditions. Not an intent to treat trial.|||units on a scale||Standard Deviation|Mean
2532305|NCT03309202|Secondary|Apparent Clearance After Oral Dose (CL/F) of PF-05221304|CL/F was calculated by Dose/AUCinf.|0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose|The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.|||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2532306|NCT03309202|Secondary|Unbound AUClast ( AUClast,u) of PF-05221304|AUClast,u was calculated by fu*AUClast.|4 hours postdose|The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2532277|NCT03311646|Secondary|Minnesota Nicotine Withdrawal Scale|Measure of withdrawal, Total Score is presented here, Range from 0-60 with higher scores indicating greater withdrawal. Participants complete this self-report questionnaire on Days 2-5 during the NNC (Baseline) and VLNC conditions. Presented here are the scores from the VLNC condition. Data from the NNC (Baseline) conditions are reported in the baseline section.|Participants complete this self-report questionnaire on Days 2-5 during the NNC (Baseline) and VLNC conditions. Presented here are the scores from the VLNC condition.|Results are presented for the 16 participants who completed both the NNC (baseline) and the VLNC conditions. Not an intent to treat trial.|||units on a scale||Standard Deviation|Mean
2532278|NCT03311646|Primary|Average Cigarettes Smoked Per Day|Measure of smoking behavior. Participants returned smoked cigarette butts each day at 12pm, creating four 24-hr samples for each hotel phase (NNC and VLNC). Outcomes reported here are from the VLNC condition. Baseline (NNC) data are reported in the baseline characteristics section.|Participants returned smoked cigarette butts each day at 12pm, creating four 24-hr samples for each hotel phase. Data reported here are for the four 24-hr samples of the VLNC condition.|Results are presented for the 16 participants who completed both the NNC (baseline) and the VLNC conditions. Not an intent to treat trial.|||Cigarettes per day||Standard Deviation|Mean
2532279|NCT03311646|Primary|Breath Sample (Expired Carbon Monoxide)|Measure of short term smoke exposure, higher scores indicate more smoke exposure. While in the hotel, participants provided breath samples at 8am, 12pm, 4pm, 8pm beginning with 4pm on Day 1 and ending with 12pm on Day 5. Outcome here are from the VLNC condition. Baseline (NNC) data are reported in the baseline characteristics section.|8am, 12pm, 4pm, 8pm beginning with 4pm on Day 1 and ending with 12pm on Day 5|Results are presented for the 16 participants who completed both the NNC (baseline) and the VLNC conditions. Not an intent to treat trial.|||parts per million||Standard Deviation|Mean
2532280|NCT03311230|Secondary|Proportion of Participant-days That Step Goals Are Achieved|proportion of days participants meet their step goal|Weeks 25 to 36 of the follow-up period.||||Proportion of participant-days|||Number
2532281|NCT03311230|Secondary|Proportion of Participant-days That Step Goals Are Achieved|proportion of days participants meet their step goal|Weeks 5 to 24 of the main intervention period.||||Proportion of participant-days|||Number
2532282|NCT03311230|Secondary|Change in Mean Daily Steps|Change in mean daily steps from baseline through the follow-up period|Weeks 25 to 36 of the follow-up period||||Steps/Day||Standard Deviation|Mean
2532283|NCT03311230|Primary|Change in Mean Daily Steps|Change in mean daily steps from baseline to main intervention period|weeks 5 to 24 of the intervention||||Steps/Day||Standard Deviation|Mean
2532284|NCT03310580|Secondary|Extent of Exposure|Exposure to study medication in days for all treatment groups|28 Days|Exposure to study medication in days for all treatment groups|||Days||Standard Deviation|Mean
2532285|NCT03310580|Primary|Mean Diurnal IOP (Intraocular Pressure) (mmHg)|Mean diurnal intraocular pressure (IOP) at week 4, measured by Goldman Applanation Tonometry (GAT).|28 Days|Intent to treat (ITT) population|||mmHg||Standard Error|Mean
2532286|NCT03310450|Secondary|Number of Participants With Pathological ECG Appearance|"Number of Participants with Pathological ECG Appearance.~Pathological ECG appearance was the results of the ECG test describing one of the pathological appearances in ECG i.e.:~The pathological rhythm which is may consist of Atrial Flutter, Atrial Fibrillation, Supraventricular Tachycardia, Ventricular Fibrillation, First Degree Heart Block, Second Degree Heart Block, Type 1 - Mobitz I, Second Degree Heart Block, Type 2 - Mobitz II, Third Degree Heart Block, or other pathological rhythm appearances~Pathological ST-segment i.e. ST elevation (early repolarization), or another form~Pathological U wave, and~other pathological appearances"|immediate after TdB 2017 cycling touring within less than 5 min|Pathological ECG appearance|||Participants|||Count of Participants
2532287|NCT03310450|Secondary|High Sensitivity C Reactive Protein (Hs-CRP)|a biomarker that represents the inflammation process|immediate after TdB 2017 cycling touring within less than 5 min||||mg/dL||Standard Deviation|Mean
2532288|NCT03310450|Primary|Malondialdehyde (MDA)|oxydative stress marker|immediate after TdB 2017 cycling touring within less than 5 min||||mcmol/mL||Standard Deviation|Mean
2532289|NCT03310450|Primary|Cardiac Troponin I (cTnI)|specific protein to determine cardiac injury|immediate after TdB 2017 cycling touring within less than 5 min||||ng/dL||Standard Deviation|Mean
2532290|NCT03310411|Secondary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0 ∞]) of Lasmiditan and Sumatriptan|PK: AUC(0 ∞) of Lasmiditan and Sumatriptan was evaluated.|Lasmiditan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12, 24 ,36 and 48 h postdose; Sumatriptan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 and 24 h postdose|All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2532291|NCT03310411|Secondary|Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan and Sumatriptan|PK: Cmax of Lasmiditan and Sumatriptan was evaluated.|Lasmiditan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 , 24 ,36 and 48 hours(h) postdose; Sumatriptan: Predose, 0.5, 1, 1.5,2, 2.5, 3, 4, 6, 8, 12 and 24 h postdose|All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2532292|NCT03310411|Primary|Pharmacodynamics (PD): Change From Baseline in Mean 24-hour Systolic Blood Pressure (SBP)|Systolic Blood Pressure (SBP) was measured by using a 24-hour Ambulatory Blood Pressure Monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least squares (LS) mean peak changes from baseline were calculated using a linear mixed-effects model with baseline, treatment, period, and sequence as fixed effects and participant as a random effect.|Baseline (Day 1), Day 2|All enrolled participants who received at least one dose of study drug with evaluable blood pressure data.|||Millimeters of mercury (mmHg)||90% Confidence Interval|Least Squares Mean
2532504|NCT03304119|Primary|Existence of Tibial Tuberosity Torsion.|This criteria will be considered relevant if it is associated with patellar dislocation. Existence Yes or No and measure of the torsion in degre on the IRM|4 reviewers Assessment of 92 IRM of patients. Study data collection from April 2010 until december 2016. Patient duration follow up not applicable.|Analysis based on the IRM available|||degre||Inter-Quartile Range|Median
2532293|NCT03310268|Secondary|Change From Baseline in Tactile Threshold After 8 Weeks of Treatment|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10 grams (g) and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Week 8|The ITT population included those participants who were randomized, received at least 1 dose of study treatment, and had at least 1 post baseline efficacy evaluation. This population was based on the treatment to which the subject was randomized. The primary population for assessment of efficacy was the ITT population.|||Grams||Standard Deviation|Mean
2532294|NCT03310268|Primary|Change From Baseline in Schiff Sensitivity Score After 8 Weeks of Treatment|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant did not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requested discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score will be indicative of an improvement in sensitivity.|Baseline, Week 8|The Intent-to-treat (ITT) population included those participants who were randomized, received at least 1 dose of study treatment, and had at least 1 post baseline efficacy evaluation. This population was based on the treatment to which the subject was randomized. The primary population for assessment of efficacy was the ITT population.|||Score on Scale||Standard Deviation|Mean
2532295|NCT03309202|Secondary|Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Data|ECG evaluation included: PR interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval), time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QT interval), QT interval corrected for heart rate using Fridericia's formula (QTcF interval), and heart rate. Clinically significant findings in ECG data were determined by the investigator.|7 days|The analysis population included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2532296|NCT03309202|Secondary|Number of Participants With Clinical Significant Findings in Vital Signs|Vital signs evaluation included: sitting systolic and diastolic blood pressure (BP), and sitting pulse rate. Clinically significant findings in vital signs were determined by the investigator.|7 days|The analysis population included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2532297|NCT03309202|Secondary|Number of Paticipants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Urinalysis|Urinalysis evaluation included: scalar urine glucose, scalar ketones, scalar urine protein, scalar urine hemoglobin, scalar urobilinogen, scalar urine bilirubin, scalar nitrite, scalar leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, and scalar bacteria.|7 days|The analysis population included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2532298|NCT03309202|Secondary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Clinical Chemistry|Clinical chemistry evaluation included: bilirubin, direct/indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase , alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, urate, sodium, potassium, chloride, calcium, phosphate, bicarbonate, creatine kinase, and fasting glucose.|7 days|The analysis population included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2532299|NCT03309202|Secondary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Hematology|Hematology evaluation included: hemoglobin, hematocrit, erythrocytes, reticulocytes, erythrocyte mean corpuscular volume, erythrocyte mean corpuscular hemoglobin concentration (MCHC), erythrocyte mean corpuscular hemoglobin, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time and prothrombin time.|7 days|The analysis population included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2532300|NCT03309202|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a study participant administered a product or medical device; the event did not need to have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and AEs. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Number of participants with both all-causality and treatment-related TEAEs are presented below.|Approximately 30 days|The analysis population included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2532301|NCT03309202|Secondary|Terminal Half-Life ( t½) of PF-05221304|t1/2 was calculated by loge(2)/kel.|0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose|The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.|||Hours||Standard Deviation|Mean
2532302|NCT03309202|Secondary|Unbound Vz/F (Vz,u/F) of PF-05221304|Vz,u/F was calculated by fu*Vz/F.|4 hours postdose|The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2532303|NCT03309202|Secondary|Apparent Volume of Distribution After Oral Dose (Vz/F) of PF-05221304|Vz/F was calculated by Dose/(AUCinf*kel). kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose|The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2532304|NCT03309202|Secondary|Unbound CL/F (CLu/F) of PF-05221304|CLu/F was calculated by fu*CL/F.|4 hours postdose|The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2532307|NCT03309202|Secondary|Area Under Concentration Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of PF-05221304|AUClast was calculated by linear/Log trapezoidal method.|0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose|The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2532308|NCT03309202|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of PF-05221304|Tmax was observed directly from data as time of first occurrence.|0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose|The analysis population included all participants who received 1 dose of PF-05221304 and in whom at least 1 plasma concentration value was reported.|||Hours||Full Range|Median
2532309|NCT03309202|Primary|Unbound AUCinf (AUCinf,u) of PF-05221304|AUCinf,u was calculated by fu*AUCinf.|4 hours postdose|The analysis population was defined as all participants dosed who had at least 1 of the PK parameters of primary interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2532310|NCT03309202|Primary|Unbound Cmax (Cmax,u) of PF-05221304|Cmax,u was calculated by fu*Cmax.|4 hours postdose|The analysis population included all participants who received 1 dose of PF-05221304 and in whom at least 1 plasma concentration value was reported.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2532311|NCT03309202|Primary|Fraction Unbound (fu) of PF-05221304|fu was the fraction of PF-05221304 unbound in plasma. fu was calculated based on the post-dialysis plasma concentrations, post-dialysis buffer concentrations, collected post-dialysis plasma and post-dialysis buffer sample volume (assuming no volume shift prior to and after dialysis), and the total plasma concentrations.|4 hours postdose|The analysis population included all participants who received 1 dose of PF-05221304 and in whom at least 1 plasma concentration value was reported.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2532312|NCT03309202|Primary|Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-05221304|AUCinf was calculated by AUClast + (Clast*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose|The analysis population included all participants dosed who had at least 1 of the PK parameters of primary interest.|||Nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2532313|NCT03309202|Primary|Maximum Plasma Concentration (Cmax) of PF-05221304|Cmax was observed directly from data.|0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose|The analysis population included all participants who received 1 dose of PF-05221304 and in whom at least 1 plasma concentration value was reported.|||Nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2532314|NCT03308968|Secondary|OL Period: Number of Participants Who Received Concomitant Medications for Adverse Events|Concomitant medications included: agents acting on the renin-angiotensin system, all other therapeutic products (for example: homeopathic preparation), allergens, analgesics, anesthetics, anti-parkinson drugs, antianemic preparations, antibacterials for systemic use, antibiotics and chemotherapeutics for dermatological use, antidiarrheals, intestinal antiinflammatory/antiinfective agents, antiemetic, antiepileptics, antifungals for dermatologiocal use, antigout preparations, antihemorrhagics, antihistamines for systemic use, antihypertensives, antiinflammatory and antirheumatic products, antimycotics for systemic use, antipruritics, antipsoriatics, antivirals for systemic use, beta blocking agents, blood substitutes and perfusion solutions, cardiac therapy, corticosteroids, cough and cold preparations, diagnostic radiopharmaceuticals, diuretics, thyroid therapy, urologicals, vaccines, psycoleptics, psycoanaleptics, ophthalmologicals, muscle relaxants, drugs used in diabetes etc.|Week 12 up to Week 24|OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.|||Participants|||Count of Participants
2532315|NCT03308968|Secondary|DB Period: Number of Participants Who Received Concomitant Medications for Adverse Events|Concomitant medications included: agents acting on the renin-angiotensin system, all other therapeutic products (for example: homeopathic preparation), allergens, analgesics, anesthetics, anti-parkinson drugs, antianemic preparations, antibacterials for systemic use, antibiotics and chemotherapeutics for dermatological use, antidiarrheals, intestinal antiinflammatory/antiinfective agents, antiemetic, antiepileptics, antifungals for dermatologiocal use, antigout preparations, antihemorrhagics, antihistamines for systemic use, antihypertensives, antiinflammatory and antirheumatic products, antimycotics for systemic use, antipruritics, antipsoriatics, antivirals for systemic use, beta blocking agents, blood substitutes and perfusion solutions, cardiac therapy, corticosteroids, cough and cold preparations, diagnostic radiopharmaceuticals, diuretics, thyroid therapy, urologicals, vaccines, psycoleptics, psycoanaleptics, ophthalmologicals, muscle relaxants, drugs used in diabetes etc.|Baseline up to Week 12|DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period.|||Participants|||Count of Participants
2532316|NCT03308968|Secondary|OL Period: Number of Participants With Shift From Baseline to Week 24 in ECG Parameters|ECG parameters included: heart rate, PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF), QT interval corrected using the Bazett's formula (QTcB) and RR interval. Shifts represented as Baseline - Week 24 value. Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline, Week 24|OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period. Here, 'Overall number of participants analyzed' = participants with both baseline and Week 24 ECG findings.|||Participants|||Count of Participants
2532338|NCT03308825|Primary|Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)|Anti-influenza antibodies were measured using the HAI assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-final vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-final vaccination titer.|Day 0 (pre-vaccination) and Day 28 (post-final vaccination)|Analysis was performed on PPAS. Here, “Number analyzed” corresponds to participants with available data for each listed strain.|||Participants|||Count of Participants
2532317|NCT03308968|Secondary|DB Period: Number of Participants With Shift From Baseline to Week 12 in Electrocardiogram (ECG) Parameters|ECG parameters included: heart rate, PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF), QT interval corrected using the Bazett's formula (QTcB) and RR interval. Shifts represented as Baseline - Week 12 value. Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline, Week 12|DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. Here, 'Overall number of participants analyzed' = participants with both baseline and Week 12 ECG findings.|||Participants|||Count of Participants
2532318|NCT03308968|Secondary|OL Period: Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values|Criteria for potentially clinically significant abnormal vital signs values included: pulse rate: ≤50 bpm and decrease of ≥15 bpm, or ≥120 bpm and increase of ≥15 bpm; systolic blood pressure: ≤90 mmHg and decrease of ≥20 mmHg, or ≥180 mmHg and increase of ≥20 mmHg; diastolic blood pressure: ≤50 mmHg and decrease of ≥15 mmHg or ≥105 mmHg and increase of ≥15 mmHg; respiratory rate: <10 breaths/minute; and body temperature ≥38.3 degrees celsius and change of ≥1.1 degrees celsius. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Week 12 up to Week 24|OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2532319|NCT03308968|Secondary|DB Period: Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values|Criteria for potentially clinically significant abnormal vital signs values included: pulse rate: ≤50 beats/minute (bpm) and decrease of ≥15 bpm, or ≥120 bpm and increase of ≥15 bpm; systolic blood pressure: ≤90 millimeters of mercury (mmHg) and decrease of ≥20 mmHg, or ≥180 mmHg and increase of ≥20 mmHg; diastolic blood pressure: ≤50 mmHg and decrease of ≥15 mmHg or ≥105 mmHg and increase of ≥15 mmHg; respiratory rate: <10 breaths/minute; and body temperature ≥38.3 degrees celsius and change of ≥1.1 degrees celsius. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to Week 12|DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2532320|NCT03308968|Secondary|OL Period: Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results|Criteria for potentially clinically significant abnormal urinalysis values included: urine glucose (mg/dL): ≥2 unit increase from baseline, ketones (mg/dL): ≥2 unit increase from baseline, urine total protein (mg/dL): ≥2 unit increase from baseline, and haemoglobin ≥2 unit increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Week 12 up to Week 24|OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.|||Participants|||Count of Participants
2532321|NCT03308968|Secondary|DB Period: Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results|Criteria for potentially clinically significant abnormal urinalysis values included: urine glucose (milligrams/deciliter [mg/dL]): ≥2 unit increase from baseline, ketones (mg/dL): ≥2 unit increase from baseline, urine total protein (mg/dL): ≥2 unit increase from baseline, and haemoglobin ≥2 unit increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to Week 12|DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period.|||Participants|||Count of Participants
2532322|NCT03308968|Secondary|OL Period: Number of Participants With Potentially Clinically Significant Abnormal Coagulation Laboratory Test Results|Criteria for potentially clinically significant abnormal coagulation values included: prothrombin INR: >1.5. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Week 12 up to Week 24|OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2532323|NCT03308968|Secondary|DB Period: Number of Participants With Potentially Clinically Significant Abnormal Coagulation Laboratory Test Results|Criteria for potentially clinically significant abnormal coagulation values included: prothrombin international normalized ratio (INR): greater than (>) 1.5. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to Week 12|DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2532324|NCT03308968|Secondary|OL Period: Number of Participants With Potentially Clinically Significant Abnormal Hematology Results|Criteria for potentially clinically significant abnormal hematology values included: hemoglobin: <115 g/L (in men) or ≤95 g/L (in women), hematocrit: <0.37 L/L (in men) or <0.32 L/L (in women), leukocytes: ≥20*10^9/L or ≤3*10^9/L, eosinophils: >=10%, platelets: ≥700*10^9/L or ≤75*10^9/L, and ANC: ≤1*10^9/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Week 12 up to Week 24|OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2532359|NCT03307252|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (T1 vs. R1)|AUC0-∞, area under the concentration-time curve of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) in plasma over the time interval from 0 extrapolated to infinity is presented. AUC0-∞ not displayed for Digoxin analyte as precision was considered non-sufficient. gMean presented here is an adjusted gMean and SE presented is a gSE.|Samples were taken within 0:20 hh:mm prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.|PKS|||Nanomole*hour/litre (nmol*h/L)||Standard Error|Geometric Mean
2532325|NCT03308968|Secondary|DB Period: Number of Participants With Potentially Clinically Significant Abnormal Hematology Results|Criteria for potentially clinically significant abnormal hematology values included: hemoglobin: less than (<) 115 grams/liter (g/L) (in men) or less than or equal to (≤) 95 g/L (in women), hematocrit: <0.37 L/L (in men) or <0.32 L/L (in women), leukocytes: ≥20*10^9/L or ≤3*10^9/L, eosinophils: >=10%, platelets: ≥700*10^9/L or ≤75*10^9/L, and absolute neutrophil count (ANC): ≤1*10^9/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to Week 12|DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2532326|NCT03308968|Secondary|OL Period: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results|Criteria for potentially clinically significant abnormal serum chemistry values included: ALT, AST, ALP, GGT, and LDH (U/L): ≥3*ULN; BUN: ≥10.71 mmol/L; creatinine: ≥177 µmol/L; bilirubin (total): ≥34.2 µmol/L; and uric acid: ≥625 µmol/L (men), and ≥506 µmol/L (women). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Week 12 up to Week 24|OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2532327|NCT03308968|Secondary|DB Period: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results|Criteria for potentially clinically significant abnormal serum chemistry values included: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), and lactate dehydrogenase (LDH) (units/liter [U/L]): greater than or equal to (≥) 3*upper limit of normal (ULN); Blood Urea Nitrogen (BUN): ≥10.71 millimoles/liter (mmol/L); creatinine: ≥177 micromoles/liter (µmol/L); bilirubin (total): ≥34.2 µmol/L; and uric acid: ≥625 µmol/L (men), and ≥506 µmol/L (women). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to Week 12|DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2532328|NCT03308968|Secondary|OL Period: Number of Participants With AEs and Who Did Not Complete the Study Due to AEs|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE was defined as inability to carry out usual activities. Treatment-related AEs were defined as AEs with possible, probable, definite, or missing relationship to study drug. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Week 12 up to Week 24|OL safety analysis set included all participants who received at least 1 dose of study drug during the OL treatment period.|||Participants|||Count of Participants
2532329|NCT03308968|Secondary|DB Period: Number of Participants With Adverse Events (AEs) and Who Did Not Complete the Study Due to AEs|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE was defined as inability to carry out usual activities. Treatment-related AEs were defined as AEs with possible, probable, definite, or missing relationship to study drug. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline (Day 0) up to Week 12|DB safety analysis set included all randomized participants who received at least 1 dose of study drug during the DB treatment period.|||Participants|||Count of Participants
2532330|NCT03308968|Secondary|DB Period: Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 4-Week Period After the First Dose of Fremanezumab|A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) demonstrating at least 4 consecutive hours of headache of at least moderate severity or; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific acute medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) * 28. The change was calculated as post-baseline value - baseline value. LS mean calculated using ANCOVA model with treatment, gender, region, special group of treatment failure (yes/no), migraine classification (EM/CM), and treatment*migraine classification as fixed effects, and baseline number of headache days of at least moderate severity and years since onset of migraines as covariates.|Baseline (Day -28 to Day -1), up to Week 4|DB mITT analysis set included participants who received at least 1 dose of study drug and had at least 10 days of postbaseline efficacy assessment on the primary endpoint.|||days/month||Standard Error|Least Squares Mean
2532331|NCT03308968|Secondary|DB Period: Change From Baseline in Monthly Average Number of Days of Use of Any Acute Headache Medications During the 12-Week Period After the First Dose of Fremanezumab|Baseline data and the mean change from baseline in the monthly average number of days of use of any acute headache medications during the 12-week period after administration of the first dose of study drug (based on Week 0 to 12 data) is reported. Least Squares (LS) mean calculated using analysis of covariance (ANCOVA) model with treatment, gender, region, special group of treatment failure (yes/no), migraine classification (EM/CM), and treatment*migraine classification as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates.|Baseline (Day -28 to Day -1), up to Week 12|DB mITT analysis set included participants who received at least 1 dose of study drug and had at least 10 days of postbaseline efficacy assessment on the primary endpoint.|||days/month||Standard Error|Least Squares Mean
2554596|NCT02756689|Secondary|Nonreassuring Fetal Heart Tracings 30-minutes After Foley Bulb Placement.||From placement until 30 minutes.||||Participants|||Count of Participants
2532332|NCT03308968|Secondary|DB Period: Percentage of Participants Reaching at Least 50% Reduction From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period After the First Dose of Fremanezumab|A migraine day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache meeting criteria for migraine with or without aura; a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period)*28.|Baseline (Day -28 to Day-1), up to Week 4|DB mITT analysis set included participants who received at least 1 dose of study drug and had at least 10 days of postbaseline efficacy assessment on the primary endpoint.|||percentage of participants|||Number
2532333|NCT03308968|Secondary|DB Period: Change From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period After the First Dose of Fremanezumab|A migraine day was defined as when at least 1 of following occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache meeting criteria for migraine with or without aura; a calendar day demonstrating at least 4 consecutive hours of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day demonstrating a headache of any duration that was treated with migraine-specific medications. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period)*28. LS mean calculated using ANCOVA model with treatment, gender, region, special group of treatment failure (yes/no), migraine classification (EM/CM), and treatment*migraine classification as fixed effects, and baseline number of migraine days and years since onset of migraines as covariates.|Baseline (Day -28 to Day -1), up to Week 4|DB mITT analysis set included participants who received at least 1 dose of study drug and had at least 10 days of postbaseline efficacy assessment on the primary endpoint.|||days/month||Standard Error|Least Squares Mean
2532334|NCT03308968|Secondary|DB Period: Change From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-Week Period After the First Dose of Fremanezumab|A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) demonstrating at least 4 consecutive hours of headache of at least moderate severity or; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific acute medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) * 28. The change was calculated as post-baseline value - baseline value. LS mean calculated using ANCOVA model with treatment, gender, region, special group of treatment failure (yes/no), migraine classification (EM/CM), and treatment*migraine classification as fixed effects and baseline number of headache days of at least moderate severity and years since onset of migraine as covariates.|Baseline (Day -28 to Day -1), up to Week 12|DB mITT analysis set included participants who received at least 1 dose of study drug and had at least 10 days of postbaseline efficacy assessment on the primary endpoint.|||days/month||Standard Error|Least Squares Mean
2532335|NCT03308968|Secondary|DB Period: Percentage of Participants Reaching at Least 50 Percent (%) Reduction From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Fremanezumab|A migraine day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache meeting criteria for migraine with or without aura; a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period)*28.|Baseline (Day -28 to Day-1), up to Week 12|DB mITT analysis set included participants who received at least 1 dose of study drug and had at least 10 days of postbaseline efficacy assessment on the primary endpoint.|||percentage of participants|||Number
2532336|NCT03308968|Primary|DB Period: Change From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Fremanezumab|A migraine day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache meeting criteria for migraine with or without aura; a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period)*28. Change was calculated as post-baseline value - baseline value.|Baseline (Day -28 to Day -1), up to Week 12|DB mITT analysis set included participants who received at least 1 dose of study drug and had at least 10 days of postbaseline efficacy assessment on the primary endpoint.|||days/month||Standard Error|Least Squares Mean
2532337|NCT03308825|Primary|Number of Participants With Seroconversion to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)|Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4). Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-final vaccination titer >= 1:40 or a pre-vaccination titer >= 1:10 and at least a 4-fold increase in post-final vaccination titer.|Day 0 (pre-vaccination) and Day 21 (post-vaccination)|Analysis was performed on PPAS. Here, “Number analyzed” corresponds to participants with available data for each listed strain and “0” in the number analyzed field signifies that none of the participants were analyzed, since the 2017-2018 formulation of Fluzone High-Dose vaccine did not contain the B Yagamata lineage strain.|||Participants|||Count of Participants
2532339|NCT03308825|Primary|Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)|Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4). Seroprotection was defined as antibody titer >= 40 (1/ dilution) at pre-vaccination or at post-final vaccination.|Day 0 (pre-vaccination) and Day 21 (post-vaccination)|Analysis was performed on PPAS. Here, “Number analyzed” corresponds to participants with available data for each listed strain and “0” in the number analyzed field signifies that none of the participants were analyzed, since the 2017-2018 formulation of Fluzone High-Dose vaccine did not contain the B Yagamata lineage strain.|||Participants|||Count of Participants
2532340|NCT03308825|Primary|Number of Participants With Seroprotection to Influenza Vaccine Antigens: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)|Anti-influenza antibodies were measured using the HAI assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage. Seroprotection was defined as antibody titer >=40 (1/ dilution) at pre-vaccination or at post-final vaccination.|Day 0 (pre-vaccination) and Day 28 (post-vaccination)|Analysis was performed on PPAS. Here, “Number analyzed” corresponds to participants with available data for each listed strain.|||Participants|||Count of Participants
2532341|NCT03308825|Primary|GMTRs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)|GMTRs are the geometric means of the individual post-final vaccination/pre-vaccination titer ratios for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4), measured using the HAI assay.|Day 0 (pre-vaccination) and Day 21 (post-vaccination)|Analysis was performed on PPAS. Here, “Number analyzed” corresponds to participants with available data for each listed strain and “0” in the number analyzed field signifies that none of the participants were analyzed, since the 2017-2018 formulation of Fluzone High-Dose vaccine did not contain the B Yagamata lineage strain.|||Titer Ratio||95% Confidence Interval|Number
2532342|NCT03308825|Primary|GMT Ratios (GMTRs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)|GMTRs are the geometric means of the individual post-final vaccination/pre-vaccination titer ratios for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage, measured using the HAI assay.|Day 0 (pre-vaccination) and Day 28 (post-final vaccination)|Analysis was performed on PPAS. Here, “Number analyzed” corresponds to participants with available data for each listed strain.|||Titer Ratio||95% Confidence Interval|Number
2532343|NCT03308825|Primary|GMTs of Influenza Vaccine Antibodies in Adults: Group 3 (18 to < 65 Years) and Group 4 (>= 65 Years)|Anti-influenza antibodies were measured using the HAI assay for each of the following 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage (for Group 3) and for 3 strains: H1N1, H3N2, and B Victoria lineage (for Group 4).|Day 0 (pre-vaccination) and Day 21 (post-vaccination)|Analysis was performed on PPAS. Here, “Number analyzed” corresponds to participants with available data for each listed strain and “0” in the number analyzed field signifies that none of the participants were analyzed, since the 2017-2018 formulation of Fluzone High-Dose vaccine did not contain the B Yagamata lineage strain.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
2532344|NCT03308825|Primary|Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies in Children: Group 1 (6 to < 36 Months) and Group 2 (3 to < 9 Years)|Anti-influenza antibodies were measured using the hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria lineage, and B Yamagata lineage.|Day 0 (pre-vaccination) and Day 28 (post-vaccination)|Per-Protocol Analysis Set (PPAS) included all participants who received at least 1dose of study vaccine, had a valid post-final vaccination serology result for at least 1 strain and did not have any major protocol deviations. Here, “Number analyzed” corresponds to participants with available data for each listed strain.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
2532345|NCT03308825|Primary|Number of Participants Reporting Solicited Injection Site (Pain, Erythema, Swelling) and Systemic Reactions(Fever, Headache, Malaise, Myalgia): Group 2 (3 to < 9 Years), Group 3 (18 to < 65 Years) and Group 4(=< 65 Years)|Solicited injection site reactions: Pain (Group 2: Grade 3: Incapacitating; Group 3 and 4: Grade 3: significant; prevents daily activity), erythema & swelling (Group 2: Grade 3: >= 50 mm, Group 3 and 4: Grade 3: > 100 mm). Solicited systemic reactions: Fever (Grade 3: >= 39.0 degrees Celsius [102.2°F]), headache, malaise & myalgia (Grade 3: significant interference with daily activities).|Within 7 days after any vaccination|Analysis was performed using Safety Analysis Set. Here, “Number analyzed” corresponds to participants with available data for each listed solicited reaction.|||Participants|||Count of Participants
2532346|NCT03308825|Primary|Number of Participants Reporting Solicited Injection Site (Tenderness/Pain, Erythema, Swelling) and Systemic Reactions (Fever, Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, Irritability): Group 1 (6 to < 36 Months)|Solicited injection site reactions: Pain, Erythema and Swelling (Grade 3: Pain: cries when injected limb moved/ limb movement reduced, erythema and swelling >= 50 mm). Solicited systemic reactions: Fever, vomiting, abnormal crying, drowsiness, appetite lost, Irritability (Grade 3: Fever: >= 39.5 degrees Celsius [103.1 degree Fahrenheit {°F}], vomiting >= six episodes per 24 hours, abnormal crying : > 3 hours, drowsiness: sleeping most of the time or difficult to wake up, appetite lost: refuses >= 3 feeds/meals or refuses most feeds/meals, Irritability: Inconsolable).|Within 7 days after any vaccination|Analysis was performed using the Safety Analysis Set. Here, “Number analyzed” corresponds to participants with available data for each listed solicited reaction.|||Participants|||Count of Participants
2532347|NCT03308799|Secondary|Psoriasis Treatment Convenience Scale|"Subject assessment of treatment convenience using a Psoriasis Treatment Convenience Scale is defined as a sum of questions 1-5, where each question is scored on a scale from 1-10.~How easy was the treatment to apply to the skin? Very difficult is 1 and Very easy is 10 How greasy was the treatment when applying it to the skin? Very greasy is 1 and Not greasy is 10 How moisturised did your skin feel after applying the treatment? Not moisturized is 1 and Very moisturized is 10 How greasy did your skin feel after applying the treatment? Very greasy is 1 and Not greasy is 10 How much did treating your skin disrupt your daily routine? Very disturbing is 1 and Not disturbing is 10"|8 weeks|The analysis population is defined as those patients from the PP population that have used study medication within 7 days prior to the day of assessment.|||score on a scale||Standard Deviation|Mean
2532348|NCT03308799|Secondary|Percentage Change in mPASI Score|"The extent and severity of the participant's psoriasis is assessed using a modified PASI scoring system (minus scalp, face, and flexures) at each 3 areas (arms, trunk and legs) using a scale from 0 - 6, where 0 = no psoriasis involvement and 6 = 90-100% involvement.~The severity is assessed at each 3 areas (arms, trunk and legs) for each of the sign redness, thickness and scaliness using a scale from 0 - 4, where 0 represents none and 4 represents very severe.~The mPASI score is calculated from the individual scores by use of the following equation:~Arms 0.2 (Redness + Thickness + Scaliness) E = X Trunk 0.3 (Redness + Thickness + Scaliness) E = Y Legs 0.4 (Redness + Thickness + Scaliness) E = Z~The sum of X + Y + Z = m-PASI score resulting in a minimum score of 0 and a maximum score (worst possible) of 64.8.~The percent change in mPASI score is defined as the Baseline minus the Week 8 divided by Baseline score multiplied by 100"|Baseline and 8 weeks|The analysis was based on the PP population.|||Percentage of change||Standard Deviation|Mean
2532349|NCT03308799|Primary|Number of Participants With a Decrease in the Physicians Global Assessment (PGA) Score of Minimum 2 Points on a Scale From 0-4 From Baseline to Week 8|"Psoriasis treatment success rate is measured at week 8 by the use of a Physician Global Assessment (PGA) score. Success is defined as a decrease from Baseline of minimum 2 point on a scale from 0 - 4, where: 0 = Clear; 1 = Almost clear; 2 = Mild Plaque thickening; 3 = Moderate Plaque thickening, 4 = Severe Plaque thickening.~The number of participants referred in the data sets are the number of participants, who achieved a successful treatment success."|Baseline and 8 weeks|The analysis was based on the PP population.|||Count of participants|||Number
2532350|NCT03308669|Secondary|PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14|PK: Area Under the Plasma Concentration versus Time Curve From Zero to Infinity AUC(0-∞) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14|Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours|All participants who received at least one dose of lasmiditan or topiramate and have evaluable PK data.|||nanograms*hour per milliliter(ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2532351|NCT03308669|Secondary|PK: Area Under the Plasma Concentration Versus Time Curve During One Dosing Interval (AUC [Tau]) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14|PK: Area Under the Plasma Concentration versus Time Curve During One Dosing Interval (AUC [tau]) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14|Day 13 and Day 14 - predose,0.5,1,1.5,2,3,4,6,8,12 hours(h)|All participants who received at least one dose of lasmiditan or topiramate and have evaluable PK data.|||nanograms*hour per milliliter(ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2532352|NCT03308669|Secondary|PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14|PK: Maximum Observed Drug Concentration (Cmax) of Lasmiditan When Administered Alone on Day 1 and When Coadministered With Topiramate on Day 14|Day 1 and Day 14: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 hours|All participants who received at least one dose of lasmiditan or topiramate and had evaluable PK data.|||Nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2532353|NCT03308669|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate When Administered Alone on Day 13 and When Coadministered With Lasmiditan on Day 14|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Topiramate when administered alone on Day 13 and when coadministered with lasmiditan on Day 14|Day 13 and Day 14: predose,0.5,1,1.5,2,3,4,6,8,12 hours(h)|All participants who received at least one dose of lasmiditan or topiramate and had evaluable PK data.|||Nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2532354|NCT03308669|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline through Day 24|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2532355|NCT03308058|Primary|Breastfeeding Assessment|Questionnaire Breastfeeding duration (Specify time) __________|0-6 months|no other primary or secondary measures to report|||days||Standard Deviation|Mean
2532356|NCT03307252|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (T4 vs. R1)|AUC0-∞, area under the concentration-time curve of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) in plasma over the time interval from 0 extrapolated to infinity is presented. AUC0-∞ not displayed for Digoxin analyte as precision was considered non-sufficient. gMean presented here is an adjusted gMean and SE presented is a gSE.|Samples were taken within 0:20 hh:mm prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.|PKS|||Nanomole*hour/litre (nmol*h/L)||Standard Error|Geometric Mean
2532357|NCT03307252|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (T3 vs. R1)|AUC0-∞, area under the concentration-time curve of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) in plasma over the time interval from 0 extrapolated to infinity is presented. AUC0-∞ not displayed for Digoxin analyte as precision was considered non-sufficient. gMean presented here is an adjusted gMean and SE presented is a gSE.|Samples were taken within 0:20 hh:mm prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.|PKS|||Nanomole*hour/litre (nmol*h/L)||Standard Error|Geometric Mean
2532358|NCT03307252|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) (T2 vs. R1)|AUC0-∞, area under the concentration-time curve of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) in plasma over the time interval from 0 extrapolated to infinity is presented. AUC0-∞ not displayed for Digoxin analyte as precision was considered non-sufficient. gMean presented here is an adjusted gMean and SE presented is a gSE.|Samples were taken within 0:20 hh:mm prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.|PKS|||Nanomole*hour/litre (nmol*h/L)||Standard Error|Geometric Mean
2532360|NCT03307252|Primary|Maximum Measured Concentration of the Analytes: Digoxin, Furosemide, Metformin, and Rosuvastatin (Cmax) (T4 vs. R1)|Cmax, maximum measured concentration of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) is presented. gMean presented here is an adjusted gMean and SE presented is a gSE.|Samples were taken within 0:20 hh:mm prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.|PKS|||Nanomole/ litre (nmol/ L)||Standard Error|Geometric Mean
2532361|NCT03307252|Primary|Maximum Measured Concentration of the Analytes: Digoxin, Furosemide, Metformin, and Rosuvastatin (Cmax) (T3 vs. R1)|Cmax, maximum measured concentration of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) is presented. gMean presented here is an adjusted gMean and SE presented is a gSE.|Samples were taken within 0:20 hh:mm prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.|PKS|||Nanomole/ litre (nmol/ L)||Standard Error|Geometric Mean
2532362|NCT03307252|Primary|Maximum Measured Concentration of the Analytes: Digoxin, Furosemide, Metformin, and Rosuvastatin (Cmax) (T2 vs. R1)|Cmax, maximum measured concentration of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) is presented. gMean presented here is an adjusted gMean and SE presented is a gSE.|Samples were taken within 0:20 hh:mm prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.|PKS|||Nanomole/ litre (nmol/ L)||Standard Error|Geometric Mean
2532363|NCT03307252|Primary|Maximum Measured Concentration of the Analytes: Digoxin, Furosemide, Metformin, and Rosuvastatin (Cmax) (T1 vs. R1)|Cmax, maximum measured concentration of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) is presented. gMean presented here is an adjusted gMean and SE presented is a gSE.|Samples were taken within 0:20 hh:mm prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.|PKS|||Nanomole/ litre (nmol/ L)||Standard Error|Geometric Mean
2532364|NCT03307252|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (Probenecid + R1 (T4) vs. R1)|AUC0-tz, area under the concentration-time curve of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) in plasma over the time interval from 0 to the last quantifiable data point is presented. gMean presented here is an adjusted gMean and SE presented is a gSE.|Samples were taken within 0:20 hh:mm prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.|PKS|||Nanomole*hour/litre (nmol*h/L)||Standard Error|Geometric Mean
2532365|NCT03307252|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (Cimetidine + R1 (T3) vs. R1)|AUC0-tz, area under the concentration-time curve of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) in plasma over the time interval from 0 to the last quantifiable data point is presented. gMean presented here is an adjusted gMean and SE presented is a gSE.|Samples were taken within 0:20 hh:mm prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.|PKS|||Nanomole*hour/litre (nmol*h/L)||Standard Error|Geometric Mean
2532366|NCT03307252|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (Rifampin + R1 (T2) vs. R1)|AUC0-tz, area under the concentration-time curve of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) in plasma over the time interval from 0 to the last quantifiable data point is presented. gMean presented here is an adjusted gMean and SE presented is a gSE.|Samples were taken within 0:20 hh:mm prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.|PKS|||Nanomole*hour/litre (nmol*h/L)||Standard Error|Geometric Mean
2532367|NCT03307252|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (Verapamil + R1 (T1) vs. R1)|AUC0-tz, area under the concentration-time curve of the analytes: digoxin, furosemide, metformin, and rosuvastatin (at cocktail doses) in plasma over the time interval from 0 to the last quantifiable data point is presented. Geometric mean (gMean) presented here is an adjusted gMean and standard error (SE) presented is a geometric SE (gSE).|Samples were taken within 0:20 hour:minutes (hh:mm) prior to first study drug administration and at 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 47:00, 71:00 and 95:00 after drug administration.|Pharmacokinetic (PK) parameter analysis set (PKS): All subjects in the TS providing at least 1 primary or secondary PK parameter that was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.|||Nanomole*hour/litre (nmol*h/L)||Standard Error|Geometric Mean
2532368|NCT03307005|Other Pre-specified|Pittsburgh Sleep Quality Index|a self report questionnaire that assess sleep quality. The scale ranges from 0-21. Scores higher than 5 indicate poor sleep quality|1 week||||score on a scale||Full Range|Mean
2532369|NCT03307005|Other Pre-specified|Epworth Sleepiness Scale|a validated questionnaire that assesses chronic subjective sleepiness. The scale ranges from 0-24 with higher values signifying more sleepiness. A binary cutpoint of 11 or higher is considered significant sleepiness.|1 week||||score on a scale||Full Range|Mean
2532370|NCT03307005|Other Pre-specified|Kansas City Cardiomyopathy Questionnaire|a validated, disease-specific quality of life measure for patients with heart failure. Raw scores vary from 22-133. Lower scores signify worst heart failure-related quality of life.|1 week||||score on a scale||Full Range|Mean
2532371|NCT03307005|Other Pre-specified|Insomnia Severity Index|a questionnaire that assesses insomnia severity with a range of score from 0-28. Scores >=15 are signify the presence of insomnia|1 week||||score on a scale||Full Range|Mean
2532372|NCT03307005|Primary|Sleep Efficiency|Mean change in sleep efficiency on second sleep study minus sleep efficiency on the first sleep study. Higher values suggest more efficient sleep. Sleep efficiency is described as a percentage.|1 week||||sleep efficiency percentage||Full Range|Mean
2532375|NCT03306589|Primary|Part 2: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF|Blood samples were planned to be collected at indicated time-points for analysis of white blood cells. Baseline value is Session 2 Day 1. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.|Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3|Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.||||||
2532376|NCT03306589|Secondary|Part 2: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm|Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.|Baseline; Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3|Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.||||||
2532377|NCT03306589|Secondary|Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm|Blood samples were collected at indicated time-points for analysis of leukocyte. Latest pre-challenge assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.|Baseline; Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3|Safety Population.|||Cells per milliliter||Standard Deviation|Mean
2532378|NCT03306589|Secondary|Part 2: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood|Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.|Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3|Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.||||||
2532379|NCT03306589|Secondary|Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood|Blood samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blood. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.|Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Mean fluorescence intensity||Standard Deviation|Mean
2532380|NCT03306589|Secondary|Part 2: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood|Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.|Baseline, Session 2: 40 minutes, 2 hour 40 minutes, 5 hour 40 minutes,9hours 40 minutes on Day 1; Pre-fluid sample on Day 2 and Day 3|Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.||||||
2532381|NCT03306589|Secondary|Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood|Blood samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for monocytes in blood. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.|Baseline; Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Mean fluorescence intensity||Standard Deviation|Mean
2532382|NCT03306589|Secondary|Part 2: Change From Baseline in Soluble Inflammatory Mediators in Blood: CRP|Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.|Baseline; Session 2: Post challenge Day 1; Pre-fluid sample on Day 2 and Day 3|Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.||||||
2532383|NCT03306589|Secondary|Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: C-reactive Protein (CRP)|Blood samples were collected at indicated time-points for the analysis of soluble inflammatory mediators like CRP in blood. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.|Baseline; Session 2: Post challenge Day 1. Pre-fluid sample on Day 2 and Day 3|Safety Population.|||Milligrams per liter||Standard Deviation|Mean
2532384|NCT03306589|Secondary|Part 2: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF for GM-CSF Arm|Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge GM-CSF assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.|Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3|Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.||||||
2532385|NCT03306589|Secondary|Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm|Blood samples were collected at indicated time-points for the analysis of soluble inflammatory mediators like TNF-alpha, IL-6 and GM-CSF in blood. Latest pre-challenge GM-CSF assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.|Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3|Safety Population.|||Picograms per milliliter||Standard Deviation|Mean
2532386|NCT03306589|Secondary|Part 2:Change From Baseline in Soluble Inflammatory Mediators in Blood|Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.|Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3|Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.||||||
2532387|NCT03306589|Secondary|Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood|Blood samples were collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like IL-1 beta, INFg, IL-2, IL-8, and MCP-1 in blood. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.|Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Picograms per milliliter||Standard Deviation|Mean
2532388|NCT03306589|Secondary|Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister|Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.|Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3|Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.||||||
2532389|NCT03306589|Secondary|Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister|Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blister like CD40+/CD80+. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.|Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Ratio||Standard Deviation|Mean
2532390|NCT03306589|Secondary|Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister|Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.|Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3|Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.||||||
2532391|NCT03306589|Secondary|Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister|Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for macrophages in blister. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.|Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Mean fluorescence intensity||Standard Deviation|Mean
2532392|NCT03306589|Secondary|Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Dendritic Cells in Blister|Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.|Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3|Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.||||||
2532393|NCT03306589|Secondary|Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Dendritic Cells in Blister|Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blister like CD40+/CD80+. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.|Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Ratio||Standard Deviation|Mean
2532394|NCT03306589|Secondary|Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister|Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.|Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3|Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.||||||
2532395|NCT03306589|Secondary|Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister|Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blister. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.|Baseline; Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Mean fluorescence intensity||Standard Deviation|Mean
2532396|NCT03306589|Secondary|Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister|Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.|Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3|Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.||||||
2532397|NCT03306589|Secondary|Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister|Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for monocytes in blister like CD40+/CD80+. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.|Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Ratio||Standard Deviation|Mean
2532398|NCT03306589|Secondary|Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister|Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.|Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3|Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.||||||
2532399|NCT03306589|Secondary|Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister|Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for monocytes in blister. Activation markers included Cluster of Differentiation (CD) 16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and Human Leukocyte Antigen - antigen D Related (HLA-DR). Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.|Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Mean fluorescence intensity||Standard Deviation|Mean
2532400|NCT03306589|Secondary|Part 2: Change From Baseline in Cell Numbers in Blister|Blood samples were planned to be collected at indicated time-points for analysis of white blood cell in blister. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.|Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3|Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.||||||
2532401|NCT03306589|Secondary|Part 1: Change From Baseline in Cell Numbers in Blister|Blister samples were collected at indicated time-points for analysis of white blood cell in blister. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.|Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Cells per milliliter||Standard Deviation|Mean
2532402|NCT03306589|Secondary|Part 2: Absolute Values of Blister Volume|Blister samples were planned to be collected at indicated time-points for analysis of blister volumes. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.|Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3|Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.||||||
2532403|NCT03306589|Secondary|Part 1: Absolute Values of Blister Volume|Blister samples were collected at indicated time-points for analysis of blister volumes. . Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline.|Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3|Safety Population.|||Microliter||Standard Deviation|Mean
2532404|NCT03306589|Secondary|Part 2: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister|Blister samples were planned to be collected at indicated time-points for the analysis of soluble inflammatory mediators like IL-1 beta, INFg, IL-6, IL-2, IL-8, MCP-1 and TNF-alpha. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.|Baseline; Session1: 48 hours Day3; Session 2: 24 hours Day 2 and 48 hours Day 3|Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.||||||
2532405|NCT03306589|Secondary|Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister|Blister samples were collected at indicated time-points for the analysis of soluble inflammatory mediators like IL-1 beta (b), Interferon-gamma (INFg), IL-6, IL-2, IL-8, Monocyte chemotactic protein-1 (MCP-1) and TNF-alpha. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.|Baseline; Session1: 48 hours on Day3; Session 2: 24 hours on Day 2 and 48 hours on Day 3|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Picograms per milliliter||Standard Deviation|Mean
2532406|NCT03306589|Primary|Part 1: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF|Blood samples were collected at indicated time-points for analysis of white blood cells. Latest pre-challenge GM-CSF assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.|Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3|Safety Population.|||Giga cells per liter||Standard Deviation|Mean
2532407|NCT03306589|Primary|Part 2: Change From Baseline Primary Soluble Inflammatory Mediators : Urinary Tetranor PGDM: LPS Arm|Urine samples were planned to be collected for analysis. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.|Baseline, Session 2 Day 1|Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.||||||
2532408|NCT03306589|Primary|Part 2: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: TNF Alpha and IL 6: LPS Arm|Blood samples were planned to be collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like TNF-alpha and IL-6 in blood. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.|Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3|Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.||||||
2532409|NCT03306589|Primary|Part 1: Change From Baseline in Primary Soluble Inflammatory Mediators : Urinary Tetranor Prostaglandin D Metabolite (PGDM) LPS Arm|The post-challenge urine samples were collected during session 2 after LPS challenge. In session 2, participants were encouraged to pass urine immediately before LPS challenge dose and urine voids were collected from after LPS until 12 hours post-LPS and the time of the urine collection were recorded as post-challenge 1 to 11. These samples were collected for measurement of tetranor-PGDM. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. The data for normalized Tetranor PGDM was normalized by (Tetranor PGDM [pg/mL] divided by Creatinine [milligram per deciliter]) multiplied by 100. NA indicates that data was not available as standard deviation could not be calculated for a single participant.|Baseline, Session 2 Day 1|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Picograms per milligram||Standard Deviation|Mean
2532410|NCT03306589|Primary|Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm|Blood samples were collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like TNF-alpha and IL-6 in blood. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Each session was for three days. NA indicates that data was not available as standard deviation could not be calculated for a single participant. All participants who were randomized to receive the treatment (LPS or GM-CSF challenge) and received one dose of challenge agent were included in Safety Population.|Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes,5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Picograms per milliliter||Standard Deviation|Mean
2532411|NCT03306420|Secondary|Part 1A Dose Escalation: Progression Free Survival Time (PFS)|Progression free survival time defined as time from start date to the date of the first documentation of objective progression of disease or death due to any cause, whichever occurs first. PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates.|From first dose of study drug administration until PD, assessed up to 15.4 months|The safety analysis set included all participants who had received at least 1 dose of the study treatment.|||Months||Full Range|Median
2532444|NCT03305419|Secondary|AUC([0-7] Following TID Dosing of GSK2982772 in Fed State of Part B|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Days 9 and 11|Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed.|||Hours*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532412|NCT03306420|Secondary|Part 1A Dose Escalation: Time to Tumor Response|Tumor response was defined as the presence of at least 1 confirmed complete response (CR) or confirmed partial response (PR) as judged by RECIST version 1.1. CR was defined for target lesions (TLs) as the disappearance of all lesions, and for non-target lesions (NTLs) as the disappearance of all non-target non-measurable lesions and/or normalization of serum levels of tumor markers. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs.|From first dose of study drug administration until PD, assessed up to 15.4 months|Data was not collected as the study was prematurely terminated due to lackluster pharmacodynamic data.||||||
2532413|NCT03306420|Secondary|Part 1A Dose Escalation: Disease Control Rate|Disease control was defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) as the best overall response according to radiological assessments as adjudicated by the IRC from randomization until the first occurrence of PD. CR defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. PD was defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started. Percentage of participants with disease control were reported.|From first dose of study drug administration until PD, assessed up to 15.4 months|The safety analysis set included all participants who had received at least 1 dose of the study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2532414|NCT03306420|Secondary|Part 1A Dose Escalation: Duration of Response|Duration of response defined as time from first documentation of objective response complete response (CR) or partial response (PR) whichever is first recorded) to date of first documentation of objective progression of disease or death due to any cause whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of longest diameter (SLD) of all lesions.|From first dose of study drug administration until PD, assessed up to 15.4 months|Data was not collected as the study was prematurely terminated due to lackluster pharmacodynamic data.||||||
2532415|NCT03306420|Secondary|Part 1A Dose Escalation: Number of Participants With Best Overall Response (BOR)|BOR was determined according to Response Evaluation Criteria in Solid Tumors version1.1(RECIST 1.1).Best response obtained among all tumor assessment visits after the date of first study drug administration until documented disease progression. BOR rate is defined as the number of participants with BOR was either confirmed complete response (CR) partial response (PR), stable disease (SD) and progressive disease (PD) relative to the number of participants belonging to the study of interest. CR:Disappearance of all target lesions; PR:At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; PD:At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|From first dose of study drug administration until PD, assessed up to 15.4 months|"The safety analysis set included all participants who had received at least 1 dose of the study treatment. Here Number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2532416|NCT03306420|Secondary|Part 1A Dose Escalation: Slope of Concentration-QTc (cQTc) Regression of M4112|Time-matched, replicate ECGs and PK samples collected in the dose-escalation phase and planned to analyze QTC response using slope analysis of exposure/response.|Baseline up to safety follow-up visit, assessed up to 15.4 months|Data was not collected as the study was prematurely terminated due to lackluster pharmacodynamic data.||||||
2532417|NCT03306420|Secondary|Part 1A Dose Escalation: Dose Normalized Pre-dose Observed Plasma Concentration (Cpre/Dose) of M4112|Dose normalized pre-dose observed plasma concentration (Cpre/dose) of M4112 was reported.|Pre-dose on Days 8, 15 (Cycle 1) and Day 1 (Cycle 2) (Each Cycle is 28 days)|PK analysis set included all participants who received M4112 and for whom at least 1 dose of M4112 and must have sufficient M4112 plasma concentration data to enable the calculation of at least 1 PK parameter. Here “number analyzed” signifies those participants who were evaluable for this outcome measure at given time points.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2532418|NCT03306420|Secondary|Part 1A Dose Escalation: Pre-dose Observed Plasma Concentration (Cpre) of M4112|Maximum pre-dose observed plasma concentration was reported.|Pre-dose on Days 8, 15 (Cycle 1) and Day 1 (Cycle 2) (Each Cycle is 28 days)|PK analysis set included all participants who received M4112 and for whom at least 1 dose of M4112 and must have sufficient M4112 plasma concentration data to enable the calculation of at least 1 PK parameter. Here “number analyzed” signifies those participants who were evaluable for this outcome measure at given time points.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2532419|NCT03306420|Secondary|Part IA Dose Escalation: Accumulation Ratio for Maximum Observed Plasma Concentration (Racc [Cmax]) of M4112|Accumulation ratio for Cmax was calculated as Cmax, Cycle 1 Day 15 divided by Cmax, Cycle 1 Day 1.|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 h post-dose on Day 1 and 15 of Cycle 1 (Each Cycle is for 28 days)|PK analysis set included all participants who received M4112 and for whom at least 1 dose of M4112 and must have sufficient M4112 plasma concentration data to enable the calculation of at least 1 PK parameter. Here “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2532420|NCT03306420|Secondary|Part 1A Dose Escalation: Accumulation Ratio for Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hour Post-dose (Racc[AUC0-8h]) of M4112|Accumulation ratio for Area Under the Plasma Concentration-Time Curve From Time Zero to 8 hours After Administration (Racc[AUC0-8h]) of M4112 was reported. Racc(AUC0-8h) calculated as AUC0-8h, on Cycle 1 Day 15 divided by AUC0-8h on Cycle 1 Day 1.|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 h post-dose on Day 1 and 15 of Cycle 1 (Each Cycle is for 28 days)|PK analysis set included all participants who received M4112 and for whom at least 1 dose of M4112 and must have sufficient M4112 plasma concentration data to enable the calculation of at least 1 PK parameter. Here “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2542093|NCT03008707|Primary|Optimal Sepsis Control||30 days|In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection|||Participants|||Count of Participants
2532421|NCT03306420|Secondary|Part 1A Dose Escalation: Dose Normalized Maximum Observed Plasma Concentration (Cmax/Dose) of M4112|Dose normalized was calculated as Cmax obtained directly from the concentration versus time curve divided by dose.|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 h post-dose on Day 1 and 15 of Cycle 1 (Each Cycle is for 28 days)|PK analysis set included all participants who received M4112 and for whom at least 1 dose of M4112 and must have sufficient M4112 plasma concentration data to enable the calculation of at least 1 PK parameter. Here “number analyzed” signifies those participants who were evaluable for this outcome measure at given time points.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2532422|NCT03306420|Secondary|Part 1A Dose Escalation: Dose Normalized Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hour Post-dose (AUC0-8/Dose) of M4112|Dose normalized was calculated as area under the plasma concentration-time curve from time zero to 8 h postdose divided by dose.|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 h post-dose on Day 1 and 15 of Cycle 1 (Each Cycle is for 28 days)|PK analysis set included all participants who received M4112 and for whom at least 1 dose of M4112 and must have sufficient M4112 plasma concentration data to enable the calculation of at least 1 PK parameter. Here “number analyzed” signifies those participants who were evaluable for this outcome measure at given time points.|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2532423|NCT03306420|Secondary|Part 1A Dose Escalation: Time to Reach Maximum Plasma Concentration (Tmax) of M4112|Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 h post-dose on Day 1 and 15 of Cycle 1 (Each Cycle is for 28 days)|PK analysis set included all participants who received M4112 and for whom at least 1 dose of M4112 and must have sufficient M4112 plasma concentration data to enable the calculation of at least 1 PK parameter. Here “number analyzed” signifies those participants who were evaluable for this outcome measure at given time points.|||Hours||Full Range|Median
2532424|NCT03306420|Secondary|Part 1A Dose Escalation: Maximum Observed Plasma Concentration (Cmax) of M4112|Pharmacokinetic PK parameter Cmax was obtained directly from the plasma concentration versus time curve.|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 h post-dose on Day 1 and 15 of Cycle 1 (Each Cycle is for 28 days)|PK analysis set included all participants who received M4112 and for whom at least 1 dose of M4112 and must have sufficient M4112 plasma concentration data to enable the calculation of at least 1 PK parameter. Here “number analyzed” signifies those participants who were evaluable for this outcome measure at given time points.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2532425|NCT03306420|Secondary|Part 1A Dose Escalation: Area Under the Plasma Concentration Curve From Time Zero to 8 Hours Post Dose AUC(0-8h) of M4112|Area under the drug concentration-time curve from 0 to 8 h post dosing for M4112. AUC0-8 was calculated according to the mixed log-linear trapezoidal rule.|Pre-dose, 0.5, 1, 2, 3, 4, 6 and 8 h post-dose on Day 1 and 15 of Cycle 1 (Each Cycle is for 28 days)|Pharmacokinetic (PK) analysis set included all participants who received M4112 and for whom at least 1 dose of M4112 and must have sufficient M4112 plasma concentration data to enable the calculation of at least 1 PK parameter. Here “number analyzed” signifies those participants who were evaluable for this outcome measure at given time points.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2532426|NCT03306420|Primary|Part 1A Dose Escalation: Number of Participants With Clinically Significant Change From Baseline in Physical Examination Abnormalities|A complete physical examination (including, general appearance, skin, pulmonary, cardiovascular, gastrointestinal, external genitourinary only as medically relevant, lymphatic, neurologic and musculoskeletal systems, head/neck, extremities, eyes, ears, nose, throat, and cognitive status) was performed. Number of participants with clinical significant change from baseline in physical examination abnormalities were reported. Clinical significance was determined by the investigator.|Baseline up to safety follow-up visit, assessed up to 15.4 months|The safety analysis set included all participants who had received at least 1 dose of the study treatment.|||Participants|||Count of Participants
2532427|NCT03306420|Primary|Part 1A Dose Escalation: Number of Participants With On-Treatment Shift in Eastern Cooperative Oncology Performance Status (ECOG PS) Score From 0 to 1|ECOG PS score is widely used by doctors and researchers to assess how a participants' disease is progressing, and is used to assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. The score ranges from Grade 0 to Grade 4, where Grade 0 = Fully active, able to carry on all pre-disease performance without restriction, Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (like light house work, office work), Grade 2 = Ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours and Grade 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. Number of participants with on-treatment shift in ECOG PS Score from 0 to 1 were reported.|Baseline up to safety follow-up visit, assessed up to 15.4 months|The safety analysis set included all participants who had received at least 1 dose of the study treatment.|||Participants|||Count of Participants
2532428|NCT03306420|Primary|Part 1A Dose Escalation: Number of Participants With Clinically Significant Abnormalities in Vital Signs|Vital signs assessment included blood pressure, pulse rate and body temperature. Number of Participants with any clinically significant abnormalities in vital signs were reported. Clinical significance was determined by the investigator.|Baseline up to safety follow-up visit, assessed up to 15.4 months|The safety analysis set included all participants who had received at least 1 dose of the study treatment.|||Participants|||Count of Participants
2532429|NCT03306420|Primary|Part 1A Dose Escalation: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters|The laboratory measurements included hematology, biochemistry and hormonal tests. Number of participants with any clinically significant abnormalities in laboratory measurements were reported. Clinical significance was determined by the investigator.|Baseline up to safety follow-up visit, assessed up to 15.4 months|The safety analysis set included all participants who had received at least 1 dose of the study treatment.|||Participants|||Count of Participants
2532445|NCT03305419|Secondary|C24 Following TID Dosing of GSK2982772 in Part B|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|24 hours post-dose on Day 14|Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532430|NCT03306420|Primary|Part 1A Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Who Experienced a Treatment Related Adverse Events (TRAE) According to National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03|"An adverse event (AE) was defined as any untoward medical occurrence in participant which does not necessarily have casual relationship with treatment was any unfavorable and unintended sign(including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal product, whether/not considered related to medicinal product. A serious adverse event(SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Term TEAE is defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs. Treatment related AE was defined as having a Possible or Related relationship to study treatment, as assessed by the Investigator."|Baseline up to safety follow-up visit, assessed up to 15.4 months|The safety analysis set included all participants who had received at least 1 dose of the study treatment.|||Participants|||Count of Participants
2532431|NCT03306420|Primary|Part 1A Dose Escalation: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs) as Per National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03|DLTs was assessed as per NCI CTCAE v 4.03. DLT defined as any Grade greater than or equal (>=) 3 nonhematological AE or Immune-related adverse event (irAE) assessed by Investigator or Sponsor during first Cycle (first 28 days) of study treatment. Asymptomatic Grade >= 3 lipase or amylase elevation not associated with clinical manifestations of pancreatitis. Any TEAE observed in subsequent cycle. Any Grade 4 neutropenia of >= 5 days duration, Grade >= 3 febrile neutropenia, Grade 3 hemoglobin decrease despite blood transfusion or erythroid growth factor. Grade 4 hemoglobin decrease assessed as related to study drug. Any Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding. Any Grade >= 3 clinical signs and symptoms related to increased QTc.|Cycle 1 (Each Cycle is of 28 days)|DLT analysis set included all participants treated in dose escalation cohorts who do not miss greater than (>) 5 planned total daily doses of M4112 in the first cycle (first 28 days) of the dose escalation part for other than DLT.|||Participants|||Count of Participants
2532432|NCT03306199|Primary|Number of Participants Free From Target Lesion Revascularization (TLR)|A Target Lesion Revascularization is defined as any percutaneous or surgical intervention to treat a restenosis or reocclusion in the target lesion|1 year||||Participants|||Count of Participants
2532433|NCT03305887|Primary|Suturing Time|The total time required to close the surgical incisions between treatment groups.|During Surgery|total 184 patients enrolled in this study, and 5 patients have no suture time, because they withdrawn from study before surgery or violated protocol, etc.|||minuts||97.5% Confidence Interval|Mean
2532434|NCT03305770|Primary|Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)|VA was assessed for each eye individually using a Snellen chart at a distance of 4 meters. A 20/20 Snellen acuity is considered normal distance eyesight. No formal hypotheses were formulated; hence no inferential testing was performed.|Dispense, Week 1, Week 2, Month 1, Month 2, Month 3|Completed Analysis Set|||eyes|eyes||Number
2532435|NCT03305731|Secondary|Change in Participation|"Client rated participation in meaningful daily life activities using the Stroke Impact Scale - Participation Subscale~The Stroke Impact Scale - Participation Subscale is a questionnaire-based measure of community participation. Participants rate their participation in 10 types of activities on a 1 to 5 point Likert-type scale. Scores are converted to a 0 to 100 scale, where low scores indicate low participation."|Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks||||score on a scale||Standard Deviation|Mean
2532436|NCT03305731|Secondary|Change in Participation|"Client rated participation in meaningful daily life activities using the Stroke Impact Scale - Participation Subscale~The Stroke Impact Scale - Participation Subscale is a questionnaire-based measure of community participation. Participants rate their participation in 10 types of activities on a 1 to 5 point Likert-type scale. Scores are converted to a 0 to 100 scale, where low scores indicate low participation."|Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks||||score on a scale||Standard Deviation|Mean
2532437|NCT03305731|Secondary|Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes|Objectively measured sedentary time (ActivPAL)|Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks||||minutes||Standard Deviation|Mean
2532438|NCT03305731|Secondary|Change in Daily Number of Sedentary Breaks|Objectively measured sedentary breaks (ActivPAL)|Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks||||breaks||Standard Deviation|Mean
2532439|NCT03305731|Primary|Change in Daily Number of Sedentary Breaks|Objectively measured sedentary breaks (ActivPAL)|Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks||||breaks||Standard Deviation|Mean
2532440|NCT03305731|Primary|Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes|Objectively measured sedentary time (ActivPAL)|Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks||||minutes||Standard Deviation|Mean
2532441|NCT03305419|Secondary|Ratio of Plasma 4 Beta-hydroxycholesterol to Cholesterol: Part B|Blood samples were collected into EDTA tubes and processed to plasma for 4 beta-hydroxycholesterol and cholesterol. Ratio of 4 beta-hydroxycholesterol to cholesterol is presented|Pre-dose on Day 1 and 24 hours post first dose on Day 14|Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed.|||Ratio||Standard Deviation|Mean
2532442|NCT03305419|Secondary|Tmax (0-7) Following TID Dosing of GSK2982772 in Fed State of Part B|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Days 9 and 11|Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed.|||Hours||Full Range|Median
2532443|NCT03305419|Secondary|Cmax (0-7) Following TID Dosing of GSK2982772 in Fed State of Part B|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Days 9 and 11|Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed.|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532446|NCT03305419|Secondary|C14 Following TID Dosing of GSK2982772 in Part B|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|14 hours post-dose on Day 14|Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532447|NCT03305419|Secondary|C7 Following TID Dosing of GSK2982772 in Part B|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|7 hours post-dose on Days 1 and 14|Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532448|NCT03305419|Secondary|C0 Following TID Dosing of GSK2982772 in Part B|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose on Day 14|Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532449|NCT03305419|Secondary|C24 Following BID Dosing of GSK2982772 in Part A|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|24 hours post-dose on Day 1|Pharmacokinetic population|||Microgram per millililter||Geometric Coefficient of Variation|Geometric Mean
2532450|NCT03305419|Secondary|C12 Following BID Dosing of GSK2982772 in Part A|"Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis.~Pharmacokinetic parameters were calculated by standard non-compartmental analysis."|12 hours post-dose on Day 1|Pharmacokinetic population|||Microgram per millilter||Geometric Coefficient of Variation|Geometric Mean
2532451|NCT03305419|Secondary|C24 Following TID Dosing of GSK2982772 in Part A|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|24 hours post-dose on Day 1|Pharmacokinetic population|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532452|NCT03305419|Secondary|Observed Trough Plasma Drug Concentration at 14 Hours (C14) Following TID Dosing of GSK2982772 in Part A|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|14 hours post-dose on Day 1|Pharmacokinetic population|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532453|NCT03305419|Secondary|Observed Trough Plasma Drug Concentration at 7 Hour (C7),Following TID Dosing of GSK2982772 in Part A|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|7 hours post-dose on Day 1|Pharmacokinetic population|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532454|NCT03305419|Secondary|Tmax (14-24) Following TID Dosing of GSK2982772 in Part B|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|14hours, 14 hours 20 and 40 minutes, 15 hours and 15 hours 30 minutes, 16, 17, 19, 22 and 24 hours post dose on Day 14|Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed.|||Hours||Full Range|Median
2532455|NCT03305419|Secondary|Tmax (7-14) Following TID Dosing of GSK2982772 in Part B|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|7hours and 7 hours 20 and 40 minutes, 8hours, 8 hours 30 minutes, 9, 10, 12, 14 hours post dose on Day 14|Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed.|||Hours||Full Range|Median
2532456|NCT03305419|Secondary|Tmax (0-7) Following TID Dosing of GSK2982772 Part B|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, 20 and 40 minutes, 1 hour, 1 hour 30 minutes, 2, 3, 5, 7 hours post dose on Days 1 and 14|Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours||Full Range|Median
2532457|NCT03305419|Secondary|Tmax (12-24) Following BID Dosing of GSK2982772 in Part A|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772.Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|12 hours, 12 hours 20 and 40 minutes, 13 hours, 13 hours 30 minutes, 14, 15, 16, 19, 22 and 24 hours post dose on Day 1|Pharmacokinetic population.|||Hours||Full Range|Median
2532458|NCT03305419|Secondary|Tmax (0-12) Following BID Dosing of GSK2982772 in Part A|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, 20 and 40 minutes, 1hour, 1 hour 30 minutes, 2, 3, 4, 6, 8, 10 hours and 12 hours post dose on Day 1|Pharmacokinetic population.|||Hours||Full Range|Median
2532459|NCT03305419|Secondary|Tmax (14-24) Following TID Dosing of GSK2982772 in Part A|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|14 hours, 14 hours 20 and 40 minutes, 15 hours, 15 hours 30 minutes, 16, 17, 19, 22 and 24 hours post dose on Day 1|Pharmacokinetic population.|||Hours||Full Range|Median
2532460|NCT03305419|Secondary|Tmax (7-14) Following TID Dosing of GSK2982772 in Part A|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|7hours, 7 hours 20 and 40 minutes, 8 hours, 8 hours 30 minutes, 9, 10, 12, 14 hours post dose on Day 1|Pharmacokinetic population.|||Hours||Full Range|Median
2532461|NCT03305419|Secondary|Time to Cmax (Tmax) (0-7) Following TID Dosing of GSK2982772 in Part A|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, and 7 hours post dose on Day 1|Pharmacokinetic population.|||Hours||Full Range|Median
2532462|NCT03305419|Secondary|Cmax (14-24) Following TID Dosing of GSK2982772 in Part B|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|14 hours, 14 hours 20 and 40 minutes, 15 hours, 15 hours 30 minutes, 16, 17, 19, 22 and 24 hours post dose on Day 14|Pharmacokinetic population.|||Microgram per millilter||Geometric Coefficient of Variation|Geometric Mean
2532463|NCT03305419|Secondary|Cmax (7-14) Following TID Dosing of GSK2982772 in Part B|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|7hours, 7 hours 20 and 40 minutes, 8 hours, 8 hours 30 minutes, 9, 10, 12, 14 hours on Day 14|Pharmacokinetic population.|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532464|NCT03305419|Secondary|Cmax (0-7) Following TID Dosing of GSK2982772 in Part B|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours post dose on Days 1 and 14|Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532465|NCT03305419|Secondary|Cmax (12-24) Following BID Dosing of GSK2982772 in Part A|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|12 hours, 12 hours 20 and 40 minutes, 13 and 13 hours 30 minutes, 14, 15, 16, 19, 22 and 24 hours post dose on Day 1|Pharmacokinetic population|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532466|NCT03305419|Secondary|Cmax (0-12) Following BID Dosing of GSK2982772 in Part A|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 4, 6, 8, 10 hours and 12 hours post dose on Day 1|Pharmacokinetic population|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532467|NCT03305419|Secondary|Cmax (14-24) Following TID Dosing of GSK2982772 in Part A|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|14 hours, 14 hours 20 and 40 minutes, 15 and 15 hours 30 minutes, 16, 19, 22 and 24 hours post dose on Day 1|Pharmacokinetic population|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532468|NCT03305419|Secondary|Cmax (7-14) Following TID Dosing of GSK2982772 in Part A|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|7 hours, 7 hours 20 and 40 minutes, 8 and 8 hours 30 minutes, 9, 10, 12, 14 hours post dose on Day 1|Pharmacokinetic population|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532469|NCT03305419|Secondary|Maximum Observed Plasma Drug Concentration Cmax (0-7) Following TID Dosing of GSK2982772 in Part A|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, and 7 hours post dose on Day 1|Pharmacokinetic population|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2532470|NCT03305419|Secondary|AUC (14-24) Following TID Dosing of GSK2982772 in Part B|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|14 hours, 14 hours 20 minutes, 14 hours 40 minutes, 15 hours, 15 hours 30 minutes, 16, 17, 19, 22 and 24 hours on Day 14|Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed|||Hours*microgram per millilter||Geometric Coefficient of Variation|Geometric Mean
2532471|NCT03305419|Secondary|AUC (7-14) Following TID Dosing of GSK2982772 in Part B|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|7 and 7 hours 20 and 40 minutes, 8 and 8 hours 30 minutes, 9, 10, 12, 14 hours on Day 14|Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed.|||Hours*microgram per millilter||Geometric Coefficient of Variation|Geometric Mean
2532472|NCT03305419|Secondary|AUC(0-7) Following TID Dosing of GSK2982772 in Part B|Blood samples were collected at indicated time-points for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Days 1 and 14|Pharmacokinetic population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hour*microgram per millilter||Geometric Coefficient of Variation|Geometric Mean
2532473|NCT03305419|Secondary|AUC (12-24) Following BID Dosing of GSK2982772 in Part A|Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|12 hours, 12 hours 20 and 40 minutes, 13 and 13 hours 30 minutes, 14, 15, 16, 19, 22 and 24 hours on Day 1|Pharmacokinetic population|||Hours*microgram per millilter||Geometric Coefficient of Variation|Geometric Mean
2532474|NCT03305419|Secondary|AUC (0-12) Following BID Dosing of GSK2982772 in Part A|Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 4, 6, 8, 10 hours,12 hours on Day 1|Pharmacokinetic population|||Hours*microgram per millilter||Geometric Coefficient of Variation|Geometric Mean
2532475|NCT03305419|Secondary|AUC (14-24) Following TID Dosing of GSK2982772 : Part A|Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|14 hours, 14 hours 20 and 40 minutes, 15 hours ,15 hours 30 minutes, 16, 19, 22 and 24 hours on Day 1|Pharmacokinetic population|||Hours*microgram per millilter||Geometric Coefficient of Variation|Geometric Mean
2532497|NCT03305055|Primary|Trajectory of Mean Wound Care Session Pain Across Sessions|Trajectory of average pain across 7 day study protocol|7-Days across sessions|Data was not collected for the minimum threshold [per the statistical analysis plan] of 6-11 consecutive wound care sessions to assess this outcome measure||||||
2532476|NCT03305419|Secondary|AUC (7-14) Following TID Dosing of GSK2982772 : Part A|Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|7 hours, 7 hours 20 and 40 minutes, 8 hours, 8 hours 30 minutes, 9, 10, 12, 14 hours on Day 1|Pharmacokinetic population|||Hours*microgram per millilter||Geometric Coefficient of Variation|Geometric Mean
2532477|NCT03305419|Secondary|AUC (0-7) Following TID Dosing of GSK2982772 : Part A|Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, 20 and 40 minutes, 1 and 1 hour 30 minutes, 2, 3, 5, 7 hours on Day 1|Pharmacokinetic population|||Hours*microgram per millilter||Geometric Coefficient of Variation|Geometric Mean
2532478|NCT03305419|Secondary|AUC[0-24] Following TID Dosing of GSK2982772: Part B|Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, 20, 40minutes, 1 hour, 1hr 30min, 2, 3, 5, 7hour, 7hr 20min,and 7hr 40 min, 8hr, 8hr 30min, 9hr, 10hr, 12hr, 14hr, 14hr 20min, 14hr 40 min, 15hr, 15hr 30min, 16hr, 17hr, 19hr, 22hr, 24hours post dose on Day14|Pharmacokinetic population. Only those participants with data available at the specified timepoints were analyzed.|||Hours*microgram per millilter||Geometric Coefficient of Variation|Geometric Mean
2532479|NCT03305419|Secondary|AUC(0-24) Following BID Dosing of GSK2982772: Part A|Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, 20min, 40min, 1hr, 1hr 30min, 2hr, 3hr, 4hr, 6hr, 8hr, 10hr, 12hr, 12hr 20min, 12hr 40min, 13hr, 13hr 30min, 14hr, 15hr, 16hr, 19hr, 22hr, 24hr post dose on Day 1.|Pharmacokinetic population.|||Hours*microgram per millilter||Geometric Coefficient of Variation|Geometric Mean
2532480|NCT03305419|Secondary|Area Under the Concentration-time Curve (AUC) From Time Zero to 24 Hours (AUC[0-24]) Following TID Dosing of GSK2982772: Part A|Blood samples were collected at indicated timepoints for pharmacokinetic analysis of GSK2982772. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, 20, 40minutes, 1 hour, 1hr 30min, 2, 3, 5, 7hour, 7hr 20min,and 7hr 40 min, 8hr, 8hr 30min, 9hr, 10hr, 12hr, 14hr, 14hr 20min, 14hr 40 min, 15hr, 15hr 30min, 16hr, 17hr, 19hr, 22hr, 24hours post dose on Day1|Pharmacokinetic population. Pharmacokinetic population consists of participants in the safety population for whom a pharmacokinetic sample were obtained and analyzed.|||Hours*microgram per millilter||Geometric Coefficient of Variation|Geometric Mean
2532481|NCT03305419|Primary|Number of Participants With Abnormal ECG Findings: Part B|12-lead ECG's were obtained in the supine position after 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.|Up to Week 4|Safety population. GSK2982772 360 mg BID of Part B was not started as one participant in GSK2982772 360 mg BID of Part A exceeded the Cmax stopping criteria|||Participants|||Count of Participants
2532482|NCT03305419|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings: Part A|12-lead ECG's were obtained in the supine position after 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.|Up to Day 4|Safety population|||Participants|||Count of Participants
2532483|NCT03305419|Primary|Number of Participants With Abnormal Vital Signs: Part B|Vital signs were measured in a supine position after 5 minutes rest. The PCI criteria for vital signs included: systolic blood pressure <85 and >160 mmHg, diastolic blood pressure <45 mmHg and >100 mmHg, heart rate <40 and >100 beats per minute, body temperature <=35.5 and >=37.8 degrees Celsius and respiration rate <=8 and >=20 breaths per minute. Data of participants with potential clinical importance has been reported.|Up to Week 4|Safety population. GSK2982772 360 mg BID of Part B was not started as one participant in GSK2982772 360 mg BID of Part A exceeded the Cmax stopping criteria|||Participants|||Count of Participants
2532484|NCT03305419|Primary|Number of Participants With Abnormal Vital Signs: Part A|Vital signs were measured in a supine position after 5 minutes rest. The PCI criteria for vital signs included: systolic blood pressure <85 and >160 millimeters of mercury [mmHg]), diastolic blood pressure <45 mmHg and >100 mmHg, heart rate <40 and >100 beats per minute, body temperature <=35.5 and >=37.8 degrees Celsius and respiration rate <=8 and >=20 breaths per minute. Data of participants with potential clinical importance has been reported.|Up to Week 9|Safety population|||Participants|||Count of Participants
2532485|NCT03305419|Primary|Number of Participants With Worst Case Urinalysis Results: Part B|Urine samples were collected from participants for analysis of following parameters: cellular casts, granular casts, hyaline casts, RBC and WBC and were counted as cells per high-power field (cells/HPF). The number of participants with cells in urine has been presented.|Up to Week 4|Safety population. GSK2982772 360 mg BID of Part B was not started as one participant in GSK2982772 360 mg BID of Part A exceeded the Cmax stopping criteria. Only those participants with data available at specified timepoints were analyzed.|||Participants|||Count of Participants
2532486|NCT03305419|Primary|Number of Participants With Worst Case Urinalysis Results: Part A|Urine samples were collected from participants for analysis of following parameters: cellular casts, granular casts, hyaline casts, RBC and WBC and were counted as cells per high-power field (cells/HPF). The number of participants with cells in urine has been presented.|Up to Week 9|Safety population. Only those participants with available data at specified time points were analyzed.|||Participants|||Count of Participants
2532498|NCT03305055|Primary|Trajectory of Mean Wound Care Session Pain Within Sessions|Trajectory of average pain within session|7-days, within session|Data was not collected for the minimum threshold [per the statistical analysis plan] of 6-11 consecutive wound care sessions to assess this outcome measure||||||
2537608|NCT03127644|Secondary|Time to a Decrease in S-K Levels of 0.5 mmol/L|The median time (hours) for S-K values to decrease by 0.5 mmol/L was measured.|From 0 to 48 hours.|The full analysis set included all patients randomised in the study.|||Hours||95% Confidence Interval|Median
2532487|NCT03305419|Primary|Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part B|Blood samples were collected from participants for analysis of following hematology parameters; hematocrit, hemoglobin, lymphocytes, platelet count, total neutrophils and WBC counts. PCI ranges were >0.54 or < 0.075 proportion of RBC in blood for hematocrit, <25 or >180 g/L for hemoglobin, 0.8 x10^9 cells/L for lymphocytes, <1.5 x10^9 cells/L for neutrophils, <100 or >550 x10^9 cells/L for platelets and <3 or 20> x 10^9 cells per liter WBC. Participants were counted in the worst case category that their value changed to low, normal or high. If values were unchanged (example: High to High), or whose value became normal, were recorded in 'No Change' category.|Up to Week 4|Safety population. GSK2982772 360 mg BID of Part B was not started as one participant in GSK2982772 360 mg BID of Part A exceeded the Cmax stopping criteria|||Participants|||Count of Participants
2532488|NCT03305419|Primary|Number of Participants With Worst Case Hematology Parameters by Potential Clinical Importance Criteria: Part A|Blood samples were collected from participants for analysis of following hematology parameters; hematocrit, hemoglobin, lymphocytes, platelet count, total neutrophils and white blood cell (WBC) counts. PCI ranges were >0.54 or < 0.075 proportion of red blood cells (RBC) in blood for hematocrit, <25 or >180 g/L for hemoglobin, 0.8 x10^9 cells/L for lymphocytes, <1.5 x10^9 cells/L for neutrophils, <100 or >550 x10^9 cells/L for platelets and <3 or 20> x 10^9 cells per liter WBC. Participants were counted in the worst case category that their value changed to low, normal or high. If values were unchanged (example: High to High), or whose value became normal, were recorded in 'No Change' category.|Up to Week 9|Safety population.|||Participants|||Count of Participants
2532489|NCT03305419|Primary|Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part B|Blood samples were collected from participants for the analysis of following clinical chemistry parameters: ALT, albumin, alkaline phosphatase, AST, calcium, creatinine, glucose, potassium, sodium and total bilirubin. PCI ranges were >=2 times ULN U/L for ALT, <30 g/L for albumin, >=2 times ULN U/L for alkaline phosphatase, >=2 times ULN U/L for AST, <2 or >2.75 mmol/L for calcium, >44.2 µmol/L for creatinine, <3 or >9 mmol/L for glucose, <3 or >5.5 mmol/L for potassium, <130 or >150 mmol/L for sodium and >=1.5 times ULN for total bilirubin. Participants were counted in the worst case category that their value changed to low, normal or high. If values were unchanged (example: High to High), or whose value became normal, were recorded in 'No Change' category.|Up to Week 4|Safety population. GSK2982772 360 mg BID of Part B was not started as one participant in GSK2982772 360 mg BID of Part A exceeded the Cmax stopping criteria|||Participants|||Count of Participants
2532490|NCT03305419|Primary|Number of Participants With Worst Case Clinical Chemistry Parameters by Potential Clinical Importance Criteria: Part A|Blood samples were collected from participants for the analysis of following clinical chemistry parameters: alanine amino transferase (ALT), albumin, alkaline phosphatase, aspartate amino transferase (AST), calcium, creatinine, glucose, potassium, sodium and total bilirubin. PCI ranges were >=2 times Upper Limit of Normal (ULN) units per liter (U/L) for ALT, <30 grams per liter (g/L) for albumin, >=2 times ULN U/L for alkaline phosphatase, >=2 times ULN U/L for AST, <2 or >2.75 millimoles per liter (mmol/L) for calcium, >44.2 micromoles per liter (µmol/L) for creatinine, <3 or >9 mmol/L for glucose, <3 or >5.5 mmol/L for potassium, <130 or >150 mmol/L for sodium and >=1.5 times ULN for total bilirubin. Participants were counted in the worst case category that their value changed to low, normal or high. If values were unchanged (example: High to High), or whose value became normal, were recorded in 'No Change' category.|Up to Week 9|Safety population|||Participants|||Count of Participants
2532491|NCT03305419|Primary|Number of Participants With AEs and SAEs: Part B|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE.|Up to Day 28|Safety population. GSK2982772 360 mg BID was not started in Part B as one participant in GSK2982772 360 mg BID of Part A exceeded the Cmax stopping criteria|||Participants|||Count of Participants
2532492|NCT03305419|Primary|Number of Subjects With Adverse Events (AEs) and Serious AEs (SAEs): Part A|An AE is any untoward medical occurrence in a clinical study subjects, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.|Up to Day 14|Safety population. Safety population consists of all randomized participants who take at least 1 dose of study treatment.|||Participants|||Count of Participants
2532493|NCT03305159|Primary|Number of Participants With Vaginal or Urinary Symptoms After Surgery, Assessed by Validated Questionnaire (Modified PRO-CTCAE)|To determine and compare the number of participants with vaginal or urinary symptoms after treatment with chlorhexidine gluconate versus povidone iodine vaginal cleansing solutions.|Day of surgery to 24-48 hours after surgery|Number of participants in control and active groups|||Participants|||Count of Participants
2532494|NCT03305055|Secondary|Depression Symptoms as Assessed by the Patient Health Questionnaire|Severity and trajectory of depression symptoms as assessed by the Patient Health Questionnaire (PHQ) 9. The questionnaire has 9 items with each rated from 0 to 3. Overall scores ranges from 0 to 27 with 1-4 being minimal depression, 5-9 being mild depression, 10-14 being moderate depression, 15-19 being moderately severe depression and 20-27 being severe depression.|37 days|Data was not collected for the minimum threshold [per the statistical analysis plan] of 6-11 consecutive wound care sessions to assess this outcome measure||||||
2532495|NCT03305055|Secondary|Post Traumatic Stress Disorder (PTSD) Symptoms as Assessed by Davidson Trauma Scale|PTSD symptoms score as assessed by Davidson Trauma Scale consisting of 17 items (symptoms) with each item measured for severity and frequency. Each item is rated 0 - 4. Overall score ranges from 0 to 136, with higher scores indicating higher frequency and severity.|37 days|Data was not collected for the minimum threshold [per the statistical analysis plan] of 6-11 consecutive wound care sessions to assess this outcome measure||||||
2532496|NCT03305055|Primary|Opiate Sparing Effect|Pro Re Nata (PRN) pain management or adjunct expressed in opiate equivalents (e.g., anxiolytic) or premed (e.g., non-protocol medications for pain, anxiety, etc); post-session (1 and 6 hours post session , e.g., pain, anxiolytic, etc).|37 days|Data was not collected for this outcome measure.||||||
2532505|NCT03303911|Secondary|Number of Participants With Holter ECG Outlier Values|Based on the mean of the triplicate recordings at each time point. Increase (↑)/decrease (↓) calculated from Baseline (BL), defined as the mean of all recordings taken prior to dosing on Day 1 (i.e. -30 minutes and -15 minutes). A participant with multiple occurrences of an event is counted only once per event.|on Day 1 and Day 25 at 30 and 15 minutes prior to the first dose and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours post dose|ECG Set: all participants who received at least 1 dose of cytisine, with at least 1 available baseline ECG and at least 1 on-treatment ECG.|||Participants|||Count of Participants
2532506|NCT03303911|Secondary|Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Parameters||up to Day 26|ECG Set: all participants who received at least 1 dose of cytisine, with at least 1 available baseline ECG and at least 1 on-treatment ECG.|||Participants|||Count of Participants
2532507|NCT03303911|Secondary|Number of Participants With Clinically Significant Values in Vital Signs and Physical Examinations||up to Day 26|Safety Set: all randomized participants who received at least one dose of cytisine.|||Participants|||Count of Participants
2532508|NCT03303911|Secondary|Number of Participants With Clinically Significant Values in Biochemistry, Hematology, and Urinalysis||up to Day 26|Safety Set: all randomized participants who received at least one dose of cytisine.|||Participants|||Count of Participants
2532509|NCT03303911|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to TEAEs|An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) is defined as an AE that results in any of the following: results in death; is life-threatening; requires hospitalisation or prolongs existing inpatient's hospitalisation; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medical event which requires medical intervention to prevent any of the above outcomes.TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.|From first dose of study drug through Day 26 plus 6-8 days|Safety Set: all randomized participants who received at least one dose of cytisine.|||Participants|||Count of Participants
2532510|NCT03303911|Secondary|Percent of Drug Excreted in Urine (Ae%)||Day 1 (6 times daily at 2-hour intervals); after the administration of the single dose of cytisine on Day 25|PK Set: All randomized subjects who completed all cytisine dosing on Days 1-3, completed >90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria.|||percentage of excreted drug||Geometric Coefficient of Variation|Geometric Mean
2532511|NCT03303911|Secondary|Cytisine Amount Excreted in Urine Over Time (Ae0-24h)||Day 1 (6 times daily at 2-hour intervals); after the administration of the single dose of cytisine on Day 25|PK Set: All randomized subjects who completed all cytisine dosing on Days 1-3, completed >90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria.|||mg||Geometric Coefficient of Variation|Geometric Mean
2532512|NCT03303911|Primary|Change From Baseline Over Time in TCQ-SF Score: Total Score|The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Total scores may range from 12 to 84, with lower scores indicating lower tobacco craving.|Baseline (Day -1), Days 4, 13, 17, 21, 26|PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results. Participants with an assessment at given time point.|||score on a scale||Standard Deviation|Mean
2532513|NCT03303911|Primary|Change From Baseline Over Time in TCQ-SF Score: Purposefulness|The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Purposefulness scores may range from 3 to 21, with lower scores indicating stronger ability to not smoke.|Baseline (Day -1), Days 4, 13, 17, 21, 26|PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.|||score on a scale||Standard Deviation|Mean
2532514|NCT03303911|Primary|Change From Baseline Over Time in TCQ-SF Score: Compulsivity|The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly agree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Compulsivity scores may range from 3 to 21, with lower scores indicating compulsion to smoke was a lesser component of tobacco craving.|Baseline (Day -1), Days 4, 13, 17, 21, 26|PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.|||score on a scale||Standard Deviation|Mean
2532529|NCT03303911|Primary|Maximum Observed Plasma Concentration (Cmax)||after the first dose and the last dose on Day 1; after the last dose on Days 2, 3, 12, 16, 20, 24; and after the morning dose on Day 25|Pharmacokinetic (PK) Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed >90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment at given timepoint.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2532530|NCT03303794|Secondary|Pain Scores During 48 Hrs Postoperatively|Will use Numeric Pain Rating Scale (NPRS) to measure pain with 0 being no pain and 10 being the worst pain.|48 hours postoperatively||||score on scale||Inter-Quartile Range|Mean
2532515|NCT03303911|Primary|Change From Baseline Over Time in TCQ-SF Score: Expectancy|The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Expectancy scores may range from 3 to 21, with lower scores indicating less positive expectations about smoking.|Baseline (Day -1), Days 4, 13, 17, 21, 26|PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results. Participants with an assessment at given time point.|||score on a scale||Standard Deviation|Mean
2532516|NCT03303911|Primary|Change From Baseline Over Time in TCQ-SF Score: Emotionality|The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Emotionality scores may range from 3 to 21, with lower scores indicating weaker emotional signs of tobacco craving.|Baseline (Day -1), Days 4, 13, 17, 21, 26|PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.|||score on a scale||Standard Deviation|Mean
2532517|NCT03303911|Primary|Change From Baseline Over Time in Urine Cotinine||Baseline, Days 4, 13, 17, 21, 26|PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.|||ng/mL||Standard Deviation|Mean
2532518|NCT03303911|Primary|Number of Participants Who Ceased or Continued Smoking on Day 26|"A status of ceased smoking is defined as not having smoked any cigarettes for the past 24 hours on Day 26 and having an expired CO level <10 ppm on Day 26."|Day 26|PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.|||Participants|||Count of Participants
2532519|NCT03303911|Primary|Change From Baseline in Expired Air CO up to Day 26||Baseline, Days 4, 13, 17, 21, 26|PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.|||ppm||Standard Deviation|Mean
2532520|NCT03303911|Primary|Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26||Baseline, Day 1 through Day 26|PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation. Participants with a valid assessment at given time point.|||cigarettes smoked in the past 24 hours||Standard Deviation|Mean
2532521|NCT03303911|Primary|Number of Cigarettes Smoked Daily During Treatment and at Day 26||Day 1 through Day 26|Pharmacodynamic (PD) Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation. Participants with a valid assessment at given time point.|||cigarettes smoked in the past 24 hours||Standard Deviation|Mean
2532522|NCT03303911|Primary|Apparent Terminal Elimination Half-Life (t1/2)||after the administration of the final dose of cytisine on Day 25|PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed >90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.|||hours||Standard Deviation|Mean
2532523|NCT03303911|Primary|Apparent Terminal Elimination Rate Constant (λz)||after the administration of the final dose of cytisine on Day 25|PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed >90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.|||1/hour||Geometric Coefficient of Variation|Geometric Mean
2532524|NCT03303911|Primary|Residual Area or Percentage of Extrapolated Part for the Calculation of AUC0-∞ (%AUC)||after the administration of the final dose of cytisine on Day 25|PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed >90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.|||percentage of extrapolated part||Geometric Coefficient of Variation|Geometric Mean
2532525|NCT03303911|Primary|Total AUC From Time Zero to Infinity (AUC0-∞)||after the administration of the final dose of cytisine on Day 25|PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed >90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2532526|NCT03303911|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Sampling Time (AUC0-t)||after the administration of the final dose of cytisine on Day 25|PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed >90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2532527|NCT03303911|Primary|Minimum Observed Plasma Concentration (Cmin)||after the first dose on Days 4, 13, 17, 21 and 25|PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed >90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment at given timepoint.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2532528|NCT03303911|Primary|Time of Occurrence of Cmax (Tmax)||after the first dose and the last dose on Day 1; after the last dose on Days 2, 3, 12, 16, 20, 24; and after the morning dose on Day 25|PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed >90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment at given time point.|||hours||Full Range|Median
2532532|NCT03303794|Primary|AM-PAC Score to Measure Patients Fitness for Discharge|AM-PAC (activity measure for post-acute care) will be used to determine if a patient is fit to discharge based on mobility with 6 being unable to mobilize up to 24 being independent. Patients who scored above 20 were considered fit to discharge.|Post-Operation Day 1||||score on scale||Inter-Quartile Range|Mean
2532533|NCT03303521|Primary|Percentage of Responders When Accounting for Missing Central Laboratory Serum Potassium Data|"The sensitivity analysis assessed the impact of subjects classified as non-responders due to missing serum potassium (S-K) data. Missing central lab (c-lab) pre-dialysis values were imputed using corresponding pre-dialysis i-STAT (a portable blood analyser) measurements. In addition, a last observation carried forward (LOCF) approach was utilized to further impute missing values of pre-dialysis S-K during the evaluation period. This technique will replace missing c-lab S-K values with the last available non-missing pre-dialysis LIDI observation recorded for that patient (and this could be a c-lab value or an imputed c-lab value). The Primary endpoint analysis was repeated on the imputed data."|Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks, starting after visit 11 and ending on visit 15, thus it comprises post-long inter-dialytic interval visits 12, 13, 14 and 15.|Full Analysis Set (all randomized patients)|||Percentage of participants|||Number
2532534|NCT03303521|Secondary|Percentage of Patients Needing Rescue Therapy|Patients requiring any urgent intervention consistent with local practice patterns to reduce serum potassium (S-K) including insulin/glucose, beta-adrenergic agonists, sodium bicarbonate, K binders or any form of renal replacement therapy.|An 8 week overall treatment period (a 4 week adjustment phase plus a 4 week evaluation phase) and a 2 week follow up period.|Full Analysis Set (all randomized patients)|||Percentage of participants|||Number
2532535|NCT03303521|Primary|Percentage of Responders|A subject was considered to be a responder if, during the evaluation period, they maintained a pre-dialysis serum potassium (S-K) between 4.0 and 5.0 mmol/L on at least 3 out of 4 dialysis treatments following the long inter-dialytic interval and did not receive rescue therapy. The S-K levels used for this analysis were based on the measurements obtained by the central laboratory.|Evaluation period runs over the last 4 weeks of the treatment period up to 8 weeks, starting after visit 11 and ending on visit 15, thus it comprises post-long inter-dialytic interval visits 12, 13, 14 and 15.|Full Analysis Set (all randomized patients)|||Percentage of participants|||Number
2532536|NCT03303417|Secondary|Bowel Habit|Assessment, via Diary, of bowel frequency Data given: stool frequency|7 days||||stools per day||Standard Deviation|Mean
2532537|NCT03303417|Secondary|Colonic Transit Time|Transit of markers through gut as assessed by the weighted average position score (total score 0-7, calculated from a score of 0-7 of each of the 5 marker pills) at 24 h on MRI A lower score indicates faster transit.|24hr||||Score on a scale||Inter-Quartile Range|Median
2532538|NCT03303417|Secondary|Colonic Volume|Ascending (AC), transverse (TC) and descending (DC) colonic volumes, measured by MRI, in mL Data given: AUC for total colon Measurements at 0, 1, 2, 3, 4, 5, 6, 7, and 8 hours post-intervention|0 - 8 hours||||ml*minutes||Standard Deviation|Mean
2532539|NCT03303417|Secondary|Small Bowel Water Content Measured by MRI, in mL|Area under the curve of change of small bowel water, 0-8 hours, measured by MRI, in mL Measurements at 0, 1, 2, 3, 4, 5, 6, 7, and 8 hours post-intervention|0 - 8 hours|14 participants completed the study|||ml*minutes||Standard Deviation|Mean
2532540|NCT03303417|Primary|Relaxation Time in Ascending Colon|Area under curve of Ascending colon T1 measured on MRI , in milliseconds. Measurements at 0, 1, 2, 3, 4, 5, 6, 7, and 8 hours post-intervention|0 - 8 hours||||seconds*minutes||Standard Deviation|Mean
2532541|NCT03302975|Secondary|Step Length|The average step length|15 weeks||||m||Standard Deviation|Mean
2532542|NCT03302975|Secondary|Average Vertical Loading Rate|The average vertical loading rate during stance phase|15 weeks||||Body Weight/second||Standard Deviation|Mean
2532543|NCT03302975|Primary|Peak Braking Force|The peak horizontal force applied in the posterior direction during the stance phase of running|15 weeks||||Body Weight||Standard Deviation|Mean
2532544|NCT03302936|Secondary|Pain Scale|Pain scale from 0-10. 0-being no pain, 10-being the most pain|Day 1: 6-8 hours after surgery||||score on a scale||Inter-Quartile Range|Median
2532545|NCT03302936|Primary|Incidence of Urinary Retention|Incidence of participants that do not pass their voiding trial and go home with an indwelling foley|Day 1||||Participants|||Count of Participants
2532546|NCT03302936|Primary|Number of Participants Considered to Have Passed Their Voiding Trial|Pyridium affect - A patient's bladder is backfilled with water prior to having foley removed. If they can void 200cc of 300cc instilled in the bladder, they are considered to have past their voiding trial.|Day 1||||Participants|||Count of Participants
2532547|NCT03302793|Secondary|Electrical Sensation Threshold|Trimmed surface electrodes (1 inch by 1 inch) were used to examine electrical sensation threshold upon application of electrical stimulation (electrical stimulator 7SA, Digitimer). To measure electrical sensation threshold, a pair of electrodes was placed next to each other centered on the thenar eminence (which is a group of muscles on the palm of the human hand at the base of the thumb); the intensity of electrical stimulation was started from zero and gradually increased in steps of 0.1 mA; and subjects were instructed to close their eyes and to say ''yes'' when they explicitly felt electrical stimulation. The electrical sensation threshold is the mA level at which a participant explicitly felt electrical stimulation. Three repetitions were made and the average was used as the electrical sensation threshold.|baseline, 10 minutes after tDCS, 10 minutes after BreEstim|In the Sham tDCS and then BreEStim arm, only 10 participants were analyzed because 2 patients did not return for the second visit.|||mA||Standard Deviation|Mean
2532558|NCT03302559|Primary|Change From Baseline in Appearance of Coarse Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)|The investigator assessed the participant's appearance of coarse lines/wrinkles using a 10-point scale where None (0)= No coarse lines/wrinkles present; skin looks completely smooth and wrinkle-free to Severe (7 to 9)= Many coarse lines/wrinkles densely packed together in the treatment area (forehead, periocular, cheeks and perioral areas) at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Week 12|ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.|||score on a scale||Standard Deviation|Mean
2532548|NCT03302793|Secondary|Electrical Pain Threshold|Trimmed surface electrodes (1 inch by 1 inch) were used to examine electrical pain thresholds upon application of electrical stimulation (electrical stimulator 7SA, Digitimer). To measure electrical pain threshold, a pair of electrodes was placed next to each other centered on the thenar eminence (which is a group of muscles on the palm of the human hand at the base of the thumb); the intensity of electrical stimulation was started from the sensation threshold level (determined in outcome measure 3) and increased in steps of 1 mA; and subjects were instructed to close their eyes and to say ''yes'' when they first felt electrical stimulation painful. The electrical pain threshold is the mA level at which a participant first felt electrical stimulation painful. To improve consistency among subjects, they were advised that the pain threshold level was equivalent to 1 on the 0-10 VAS scale. Three repetitions were made and the average was used as the electrical pain threshold.|baseline, 10 minutes after tDCS, 10 minutes after BreEstim|In the Sham tDCS and then BreEStim arm, only 10 participants were analyzed because 2 patients did not return for the second visit.|||mA||Standard Deviation|Mean
2532549|NCT03302793|Primary|Pain as Assessed by Visual Analogue Scale (VAS)|A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. To allow a continuous assessment of pain, VAS uses a 10 cm line labelled at '0' with 'no pain' and '10' with 'worst pain'. The line is marked at a point corresponding to the assessment of the pain.|baseline, 10 minutes after tDCS, 10 minutes after BreEstim|In the Sham tDCS and then BreEStim arm, only 10 participants were analyzed because 2 patients did not return for the second visit.|||units on a scale||Standard Deviation|Mean
2532550|NCT03302559|Secondary|Change From Baseline in Spectrophotometer L* Value (a Measurement of Skin Brightness)|Triplicate spectrophotometer readings were taken of the participant's face (Normal Skin and Target Lesions) at Baseline and Week 12. L* value scores range from 0=black to 100=white. An increase in the spectrophotometer L* values indicates improvement. A positive change from Baseline indicates improvement.|Baseline (Day 1) to Week 12|ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated. Number analyzed is the number of participants with data available at the given time-point for analysis.|||score on a scale||Standard Error|Mean
2532551|NCT03302559|Secondary|Investigator's Global Improvement Assessment for Tactile Roughness|The investigator assessed the global improvement in the participant's overall tactile roughness compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of tactile roughness (approximately 95% or better overall improvement).|Baseline (Day 1) to Week 12|ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.|||score on a scale||Standard Deviation|Mean
2532552|NCT03302559|Secondary|Investigator's Global Improvement Assessment for the Appearance of Coarse Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)|The investigator assessed the global improvement in the participant's overall appearance of coarse lines/wrinkles compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of coarse lines/wrinkles (approximately 95% or better overall improvement).|Baseline (Day 1) to Week 12|ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.|||score on a scale||Standard Deviation|Mean
2532553|NCT03302559|Secondary|Investigator's Global Improvement Assessment for the Appearance of Fine Lines/Wrinkles (Forehead, Periocular, Cheeks, Perioral Areas Individually Assessed)|The investigator assessed the global improvement in the participant's overall appearance of fine lines/wrinkles compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Complete clearing in the appearance of fine lines/wrinkles (approximately 95% or better overall improvement).|Baseline (Day 1) to Week 12|ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.|||score on a scale||Standard Deviation|Mean
2532554|NCT03302559|Secondary|Investigator's Global Improvement Assessment for Overall Photodamage|The investigator assessed the global improvement in the participant's overall photodamage compared to Baseline using a 5-point scale where None (0)= No change or worsening to Complete (4)= Almost complete improvement of the condition with a trace of signs/symptoms remaining (approximately 95% or better overall improvement).|Baseline (Day 1) to Week 12|ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.|||score on a scale||Standard Deviation|Mean
2532555|NCT03302559|Secondary|Change From Baseline in Appearance of Fine Lines Score Using the Allergan Fine Lines Visual Scale|The investigator assessed the participant's fine lines using the Allergan Fine Lines Visual 5-Point Scale where None (0)= No fine lines to Diffuse (4)= Diffuse superficial lines; crosshatching at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Week 12|ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.|||score on a scale||Standard Deviation|Mean
2532556|NCT03302559|Secondary|Change From Baseline in Skin Roughness Score Using the Allergan Skin Roughness Visual Scale|The investigator assessed the participant's skin roughness using the Allergan Skin Roughness Visual 5-Point Scale where None (0)= Smooth visual skin texture to Extreme (4)= Extremely coarse visual skin texture, crosshatched deep creases; extreme elastosis at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Week 12|ITT Population included all enrolled participant who applied study treatment and completed one follow-up visit after test product was initiated.|||score on a scale||Standard Deviation|Mean
2532557|NCT03302559|Primary|Change From Baseline in Tactile Roughness Score|The investigator assessed the participant's tactile roughness in the entire face using a 10-point scale where None (0)= No roughness of the treatment area; skin is completely smooth and pliable to Severe (7 to 9)= Marked roughness of the treatment area associated with stiff feeling at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Week 12|ITT Population included all enrolled participants who applied study treatment and completed one follow-up visit after test product was initiated.|||score on a scale||Standard Deviation|Mean
2532559|NCT03302559|Primary|Change From Baseline in Appearance of Fine Lines/Wrinkles Score (Forehead, Periocular, Cheeks and Perioral Areas Individually Assessed)|The investigator assessed the participant's appearance of fine lines/wrinkles using a 10-point scale where None (0)= No fine lines/wrinkles present; skin looks completely smooth and wrinkle-free to Severe (7 to 9)= Many coarse lines/wrinkles densely packed together in the treatment area (forehead, periocular, cheeks and perioral areas) at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Week 12|ITT Population included all enrolled participants who applied the test product and completed one follow-up visit after test product was initiated.|||score on a scale||Standard Deviation|Mean
2532560|NCT03302559|Primary|Change From Baseline in Overall Photodamage Score|The investigator assessed the participant's overall photodamage using a 10-point scale where None (0)= Facial skin is smooth to the touch, without significant fine/coarse line or skin tone unevenness in any areas (periocular, cheeks, forehead and perioral areas) to Severe (7 to 9)= Facial skin shows 3 or more areas (periocular, cheeks, forehead and perioral areas) of significant roughness, skin tone unevenness (red/brown), or fine/coarse lines at Baseline and Week 12. A decrease in score indicates improvement. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Week 12|ITT Population included all enrolled participants who applied the test product and completed one follow-up visit after test product was initiated.|||score on a scale||Standard Deviation|Mean
2532561|NCT03301844|Other Pre-specified|Compliance to Treatment Evaluated by Counting the Applications (Wet Wipes) to Each Eyes|"Adherence to treatment was evaluated at Visit 3 by counting given wipes/gauze and unused/lost/damaged wipes/gauze.~The compliance to treatment was evaluated by counting given wipes/gauze and unused/lost/damaged wipes/gauze. The following formula was applied:~(Given wipes/gauze − (sum of unused/lost/damaged wipes/gauze)) / Expected number of wipes/gauze used) x 100. Where the given wipes/gauze were 60 and the expected number of wipes/gauze used were 2 per days per 4 weeks = 56."|From Visit 2 (baseline) to Visit 3 (week 4)|Patiens with symmetrical bilateral posterior blepharitis who applied treatment at least once in one eye.|||percentage of Application (Wet Wipes)||Standard Deviation|Mean
2532562|NCT03301844|Other Pre-specified|Incidence of Ocular Adverse Events Reported Throughout the Study|A targeted physical examination was performed at all visits and monitoring for ocular and systemic adverse events occurred throughout the study|From Visit 2 (baseline) to Visit 3 (week 4)|"Patiens with symmetrical bilateral posterior blepharitis who applied treatment at least once in one eye.~One patient reported a treatment-emergent systemic adverse event, i.e. “Suspected colon cancer” of mild severity that led to permanent treatment discontinuation."|||Participants|||Count of Participants
2532563|NCT03301844|Secondary|Number of Patients Preferring the Standard or the Study Treatment (i.e. Answers to a Specific Question on Patient Preference: Study Drug vs. Standard Treatment)|At the end of study patients was asked to state their preference on the treatments used.|at Visit 3 (week 4)|Patiens with symmetrical bilateral posterior blepharitis who applied treatment at least once in one eye and had a baseline evaluation of the primary efficacy endpoint. One patient didn't express the preference therefore 17 patients were considered.|||Participants|||Count of Participants
2532564|NCT03301844|Secondary|Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (Improved vs Not Improved)|"For each eye change from baseline to week 4 in the total score of Meibomian Gland Dysfunction was also expressed as one of the following outcomes:~Eye on Blephapad Combo: Improved-Eye on Standard: Improved~Eye on Blephapad Combo: Improved-Eye on Standard: NOT Improved~Eye on Blephapad Combo: NOT Improved-Eye on Standard: Improved~Eye on Blephapad Combo: NOT Improved-Eye on Standard: NOT Improved~The total score was automatically computed by the system as the sum of the six sub-scores (i.e. Lid margin findings of vascularity, Plugging of gland orifices, Lid margin irregularity, Lid margin thickening, Partial glands and Gland dropout), ranging from 0 to 15 (higher values rapresent a worse outcome).If the change of the total score was positive or equal to 0 the specific eye was referred as NOT improved,on the contrary if the change of the total score resulted negative the specific eye was referred as Improved. For each patient the results on the two eyes were combined."|From Visit 2 (baseline) to Visit 3 (week 4)|Patiens with symmetrical bilateral posterior blepharitis who applied treatment at least once in one eye and had a baseline evaluation of the primary efficacy endpoint.|||Participants|||Count of Participants
2532565|NCT03301844|Primary|Percentage Change of the Total Score of the Grading Scales for Meibomian Gland Dysfunction (MGD)|"The total score of the meibomian gland dysfunction (MGD) grading scale was automatically computed by the system as the sum of the six sub-scores (i.e. Lid margin findings of vascularity, Plugging of gland orifices, Lid margin irregularity, Lid margin thickening, Partial glands and Gland dropout), ranging from 0 to 15, where higher values rapresent a worse outcome.~The first four parameters were evaluated using photographic images of anterior segments, while the last two were evaluated using infrared images of the meibomian glands Based on the percentage change from baseline to week 4 of the total score of MGD score, Investigators will choose which of the two eyes had a better change of clinical features."|from baseline to week 4|patients with symmetrical bilateral posterior blepharitis|||percentage of change in the total score||Standard Deviation|Mean
2532566|NCT03301779|Primary|% Red Blood Cells Recovered Post-Filtration|Percentage of red blood cells recovered after the filtration process.|Post-Filtration on Day 0||||% of Red Blood Cells Recovered||Standard Deviation|Mean
2532567|NCT03301779|Primary|Dual Label 24 Hour In Vivo % Recovery of Red Blood Cells|The mean 24-hour, post-transfusion, in vivo red blood cell recovery.|Day 42 of storage||||% Recovery of Red Blood Cells||Standard Deviation|Mean
2532568|NCT03301779|Primary|% of Red Blood Cells With Hemolysis|Percentage of packed Red Blood Cell units with hemolysis at day 42 of storage.|On day 42 of storage||||% of Red Blood Cells with Hemolysis||Standard Deviation|Mean
2532569|NCT03301649|Secondary|Percentage of All Randomized (Index + Non-Index) Participants Who Were Considered a Treatment Success: mITT Population|Treatment success was defined as the absence of live lice. Non-index participant: Any household member who agreed to participate in the study but was not the youngest household member. Index participant: The youngest household member who was randomized into the study.|Day 15 ± 2|mITT population included all randomized participants who met all inclusion/exclusion criteria, applied the study product as instructed, and returned for at least one post-baseline evaluation visit.|||percentage of participants|||Number
2542094|NCT03008707|Primary|Short-term Mortality||30 days|In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection|||Participants|||Count of Participants
2532570|NCT03301649|Secondary|Percentage of All Randomized (Index + Non-Index) Participants Who Were Considered a Treatment Success: PP Population|Treatment success was defined as the absence of live lice. Non-index participant: Any household member who agreed to participate in the study but was not the youngest household member. Index participant: The youngest household member who was randomized into the study. Therapeutic equivalence evaluation between test (generic ivermectin lotion 0.5%) and reference groups (Sklice [ivermectin] lotion 0.5%) was done in this endpoint, hence placebo group was not included.|Day 15 ± 2|PP population: randomized participants who met all eligibility criteria, applied study drug, were treatment successes/failures and made the final study visit (Day 15 ± 2), and had no significant protocol deviations.|||percentage of participants|||Number
2532571|NCT03301649|Primary|Percentage of Index Participants Who Were Considered a Treatment Success: mITT Population|Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study.|Day 15 ± 2|Index participants in mITT population. mITT population included all randomized participants who met all inclusion/exclusion criteria, applied the study product as instructed, and returned for at least 1 post-baseline evaluation visit.|||percentage of participants|||Number
2532572|NCT03301649|Primary|Percentage of Index Participants Who Were Considered a Treatment Success: PP Population|Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study. Therapeutic equivalence evaluation between test (generic ivermectin lotion 0.5%) and reference groups (Sklice [ivermectin] lotion 0.5%) was done in this endpoint, hence placebo group was not included.|Day 15 ± 2|Index participants in PP population. PP population: randomized participants who met all eligibility criteria, applied study drug, were treatment successes/failures and made the final study visit ( Day 15 ± 2), and had no significant protocol deviations.|||percentage of participants|||Number
2532573|NCT03301298|Secondary|Pharmacokinetic: Food Effect, CMax|To evaluate the effect of food on the PK of SXC-2023. The log transformed values of total CMax will be analyzed using a linear mixed effect model with formulation, period, sequence, and carryover as fixed effects and subject as a random effect.|Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.|"Cohort 5 participated in treatment under fasted conditions, followed by treatment under fed conditions. Other Cohorts did not participate.~Subject 5004 received fasted treatment but discontinued prior to fed treatment."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2532574|NCT03301298|Secondary|Pharmacokinetic: Food Effect, AUC|To evaluate the effect of food on the PK of SXC-2023. The log transformed values of total AUC will be analyzed using a linear mixed effect model with formulation, period, sequence, and carryover as fixed effects and subject as a random effect.|Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.|"Cohort 5 participated in treatment under fasted conditions, followed by treatment under fed conditions. Other Cohorts did not participate.~Subject 5004 received fasted treatment but discontinued prior to fed treatment."|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2532575|NCT03301298|Secondary|Pharmacokinetic Assessments: AUC|Area under the plasma concentration-time curve|Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.||||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2532576|NCT03301298|Secondary|Pharmacokinetics Assessments: Tmax|Time to peak plasma concentration|Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.|Subject 1008 who received Treatment A in Cohort 1 did not have any measureable concentration of SXC-2023, NAC, or p-toluic acid and was excluded from the PK population.|||hours||Full Range|Mean
2532577|NCT03301298|Secondary|Pharmacokinetic Assessments: Cmax|Peak plasma concentration|Samples collected at 0, 1/12, 1/6, 1/4, 1/2, 3/4, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours following dosing.||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2532578|NCT03301298|Primary|Number of Subjects Experiencing TEAEs.|Treatment related adverse events as a measure of safety and tolerability of SXC-2023. Measured by patient reporting, assessment of vital signs and laboratory assessments.|8 days||||participants|||Number
2532579|NCT03300843|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 6 months and 11 days||||Participants|||Count of Participants
2532580|NCT03300843|Secondary|Number of Participants With 2-3 Fold Increase From Baseline in Reactivity to Circulating Antigen-specific T Cells to the Mutated Peptide Compared to the Non-mutated Peptide|Enzyme-linked immunosorbent assay (ELISA) and enzyme-linked immune absorbent spot (ELISpot) assays assessed reactivity to the mutated peptide compared to the non-mutated peptide. Differences of 2-3 fold in these assays over the baseline measurement are indicative of true biologic differences.|Day 0, Day 14 (± 5 d), Day 28 (± 5 d), and Day 42 (± 5 d)||||Participants|||Count of Participants
2532581|NCT03300843|Primary|Percentage of Patients Who Had a Clinical Response (Complete Response (CR) + Partial Response (PR)) to Treatment|Response was assessed by the RECIST v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|up to 6 months||||percentage of participants||95% Confidence Interval|Number
2532582|NCT03300674|Secondary|Adverse Events|Any new symptom development after administration of investigational medication|4 hours||||Participants|||Count of Participants
2532583|NCT03300674|Secondary|Rescue Medication|no need for off-protocol parenteral pain medication during the ED visit. The following parenteral medications will be considered off protocol pain medication: any opioid, any non-steroidal anti-inflammatory drug|4 hours||||Participants|||Count of Participants
2556559|NCT02722330|Secondary|Sound Processor Magnet Selection at 4 Weeks|Information about sound processor magnet selection, type of SP magnet|4 weeks||||Participants|||Count of Participants
2532585|NCT03300570|Secondary|Percentage of Participants With Grade 3 or Higher Diarrhea Per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|The overall adverse event rates (percentages) for grade 3 or higher adverse events regardless of attribution to treatment are reported below. The percentages below are summarized for Diarrhea.|Up to 21 days||||percentage of patients|||Number
2532586|NCT03300570|Secondary|Pharmacodynamic (PD) Response Rate|Each participant will be assessed for PD response. The calculation is based on the standardized difference in means for the pharmacological effect on cGMP levels at the participant level, where a subject with a z >= 1.645 will be considered a PD responder. A participant with a z < 1.645 will be considered a non-responder. The PD response rate (percentage) of patients are summarized below by arm.|Baseline to 7 days||||percentage of patients|||Number
2532587|NCT03300570|Primary|Pharmacological Effect on Cyclic Guanosine Monophosphate (cGMP) Levels for Dolcanatide Arm Versus (vs.) Placebo, as Measured by the Differences in Mean cGMP Levels After 7 Days of Intervention|Pharmacological effect on cyclic guanosine monophosphate (cGMP) levels for dolcanatide arm versus (vs.) placebo, where this effect is defined as the arithmetic difference in mean cGMP levels before and after 7 days of dolcanatide from subject biopsies. This represents the increase in cGMP stimulated by 7 days of dolcanatide in an individual subject. The mean cGMP value will be calculated based on 6 biopsies collected from the rectum during a flexible sigmoidoscopy procedure. Each biopsy was analyzed in triplicate using a commercially available EIA kit.|Baseline to 7 days|Only patients who completed the study in the Participant Flow are included in this analysis.|||pmol/mg||Standard Deviation|Mean
2532588|NCT03300466|Secondary|Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale|The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator.|2 weeks, 3, 9, 12, 15 and 18 months||||percentage of participants|||Number
2532589|NCT03300466|Primary|Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale|The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator.|6 months||||percentage of participants|||Number
2532590|NCT03300024|Secondary|Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft|At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention|At 24 months after Graft Placement|Data was not collected for this outcome measure||||||
2532591|NCT03300024|Secondary|Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft|At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention|At 18 months after Graft Placement|Data was not collected for this outcome measure||||||
2532592|NCT03300024|Secondary|Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft|At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention|At 12 months after Graft Placement|Data was not collected for this outcome measure||||||
2532593|NCT03300024|Secondary|Percentage of Patients Requiring Revisional Procedures of the Arteriovenous Graft|At hemodialysis, the grafts will be accessed with 15 or 17 gauge needles inserted at any angle between 25-30 degrees (the same method used for a native arterio-venous fistula). If by physical examination the graft is thrombosed, then the patient will immediately be referred for endovascular thrombectomy and revision. If the graft is patent, but problematic, the patient will be referred for an urgent fistulogram and endovascular reintervention|At 6 months after Graft Placement|Data was not collected for this outcome measure||||||
2532594|NCT03300024|Secondary|Steal Syndrome|Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.|At 24 months after Graft Placement|Data was not collected for this outcome measure||||||
2532595|NCT03300024|Secondary|Steal Syndrome|Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.|At 18 months after Graft Placement|Data was not collected for this outcome measure||||||
2532596|NCT03300024|Secondary|Steal Syndrome|Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.|At 12 months after Graft Placement|Data was not collected for this outcome measure||||||
2532597|NCT03300024|Secondary|Steal Syndrome|Steal syndrome will be staged per standard as follows: Stage I: pale/blue and/or cold hand without pain; Stage II: Pain during exercise and/or hemodialysis; Stage III: Rest pain; Stage IV: Ulcers/necrosis/gangrene. Accordingly, surgical intervention will be carried out for patients with stage III or IV steal.|At 6 months after Graft Placement|Data was not collected for this outcome measure||||||
2532598|NCT03300024|Secondary|Percentage of Patients With Surgical Site Infection|The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.|At 24 months after Graft Placement|Data was not collected for this outcome measure||||||
2562410|NCT02638337|Secondary|Change From Baseline in Luteinizing Hormone at Week 12||Baseline and Week 12|Intent-to-treat population with available data|||IU/L||Standard Deviation|Mean
2532600|NCT03300024|Secondary|Percentage of Patients With Surgical Site Infection|The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.|At 12 months after Graft Placement|Data was not collected for this outcome measure||||||
2532601|NCT03300024|Secondary|Percentage of Patients With Surgical Site Infection|The presence of erythema or purulent drainage at the surgical incision and need for intravenous antibiotics or surgical intervention.|At 6 months after Graft Placement|Data was not collected for this outcome measure||||||
2532602|NCT03300024|Secondary|Incidence of Pseudoaneurysms Formation at the Access Site||At 24 months after Graft Placement|Data was not collected for this outcome measure||||||
2532603|NCT03300024|Secondary|Incidence of Pseudoaneurysms Formation at the Access Site||At 18 months after Graft Placement|Data was not collected for this outcome measure||||||
2532604|NCT03300024|Secondary|Incidence of Pseudoaneurysms Formation at the Access Site||At 12 months after Graft Placement|Data was not collected for this outcome measure||||||
2532605|NCT03300024|Secondary|Incidence of Pseudoaneurysms Formation at the Access Site||At 6 months after Graft Placement|Data was not collected for this outcome measure||||||
2532606|NCT03300024|Primary|Percentage of Patients With Functional Patency|Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)|Two years after Graft Placement|Data was not collected for this outcome measure||||||
2532607|NCT03300024|Primary|Percentage of Patients With Secondary Graft Patency|Secondary patency is defined as the interval from graft placement to graft failure.|Two years after Graft Placement|Data was not collected for this outcome measure||||||
2532608|NCT03300024|Primary|Percentage of Patients With Primary-Assisted Graft Patency|Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.|Two years after Graft Placement|Data was not collected for this outcome measure||||||
2532609|NCT03300024|Primary|Percentage of Patients With Primary Graft Patency|Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).|Two years after Graft Placement|Data was not collected for this outcome measure||||||
2532610|NCT03300024|Primary|Percentage of Patients With Functional Patency|Functional patency represents the interval from the first time the graft is used for hemodialysis to any qualifying event (stenosis, thrombosis, graft failure)|One year after Graft Placement|Data was not collected for this outcome measure||||||
2532611|NCT03300024|Primary|Percentage of Patients With Secondary Graft Patency|Secondary patency is defined as the interval from graft placement to graft failure.|One year after Graft Placement|Data was not collected for this outcome measure||||||
2532612|NCT03300024|Primary|Percentage of Patients With Primary-Assisted Graft Patency|Assisted primary patency is defined as the interval from graft placement to the first episode of complete occlusion.|One year after Graft Placement|Data was not collected for this outcome measure||||||
2532613|NCT03300024|Primary|Percentage of Patients With Primary Graft Patency|Primary patency is defined as the interval from graft placement to any intervention for stenosis with or without complete occlusion (thrombosis).|One year after Graft Placement|Data was not collected for this outcome measure||||||
2532614|NCT03298867|Secondary|Change From Baseline in the Graves' Ophthalmopathy Quality of Life (GO-QoL) Questionnaire Overall Score to Week 24|The GO-QoL is a 16-item self-administered questionnaire divided into 2 subsets and used to assess the perceived effects of TED by the subjects on (i) their daily physical activity as it relates to visual function, and (ii) psychosocial functioning. The range of the GO-QoL overall transformed scores is 0 to 100, where higher values correspond to better quality of life.|Baseline, up to Week 24|Intent-to-treat population: all randomized participants.|||score on a scale||Standard Error|Least Squares Mean
2532615|NCT03298867|Secondary|Percentage of Participants Who Were Diplopia Responders at Week 24|"Diplopia responders were defined as participants with Baseline diplopia Subjective Diplopia Score grade >0 in the study eye who had a reduction of ≥1 grade with no corresponding deterioration (≥1 grade worsening) in the fellow eye at Week 24. Denominator is the number of subjects with diplopia at Baseline.~The Subjective Diplopia Score is a clinical measure of diplopia severity on a grade scale of 0 to 3: 0=no diplopia; 1=intermittent (diplopia in primary position of gaze, when tired or when first awakening); 2=inconstant (diplopia at extremes of gaze); 3=constant (continuous diplopia in primary or reading position)."|Week 24|Intent-to-treat population: all randomized participants with diplopia at baseline.|||percentage of participants|||Number
2532616|NCT03298867|Secondary|Change From Baseline in Proptosis to Week 24||Baseline, up to Week 24|Intent-to-treat population: all randomized participants.|||mm||Standard Error|Least Squares Mean
2532617|NCT03298867|Secondary|Percentage of Participants Who Were CAS Categorical Responders at Week 24|"CAS categorical responders were defined as participants with a reduction to a CAS of 0 or 1 (no or minimal inflammatory symptoms).~The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to active (inflammatory phase) thyroid eye disease/ Graves' Ophthalmopathy or Orbitopathy (TED/GO); 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active (inflammatory phase) TED/GO (ignore equivocal redness); 6. Chemosis; 7. Inflammation of caruncle or plica. Each item is scored (1=present; 0=absent) and scores for each item are summed for total score of 0 (no inflammatory symptoms) to 7 (most inflammatory symptoms)."|Week 24|Intent-to-treat population: all randomized participants.|||percentage of participants|||Number
2532618|NCT03298867|Secondary|Percentage of Participants Who Were Overall Responders at Week 24|"Overall responders were defined as participants with a ≥2 mm reduction in proptosis AND a ≥2 point reduction in Clinical Activity Score (CAS) from Baseline in the study eye, without deterioration (≥2 mm increase in proptosis or ≥2 point increase in CAS) in the fellow eye at Week 24.~The CAS is a 7-item description of clinical activity, including: 1. Spontaneous orbital pain; 2. Gaze evoked orbital pain; 3. Eyelid swelling that is considered to be due to active (inflammatory phase) thyroid eye disease/ Graves' Ophthalmopathy or Orbitopathy (TED/GO); 4. Eyelid erythema; 5. Conjunctival redness that is considered to be due to active (inflammatory phase) TED/GO (ignore equivocal redness); 6. Chemosis; 7. Inflammation of caruncle or plica. Each item is scored (1=present; 0=absent) and scores for each item are summed for total score of 0 (no clinical activity) to 7 (most clinical activity)."|Week 24|Intent-to-treat population: all randomized participants.|||percentage of participants|||Number
2532619|NCT03298867|Primary|Percentage of Participants Who Were Proptosis Responders at Week 24|Proptosis responders were defined as participants with a ≥2 mm reduction from Baseline in proptosis in the study eye, without deterioration (≥2 mm increase) of proptosis in the fellow eye at Week 24.|Week 24|Intent-to-treat population: all randomized participants.|||percentage of participants|||Number
2532620|NCT03298113|Other Pre-specified|Pain Related to Product Application: IAD 2A|"Pain scores related to application of skin protectants for IAD 2A patients (Wong-Baker FACES® Pain Rating Scale). The table details the reduction in pain experienced by subjects able to report at their last recorded application event relative to baseline. More extreme negative values denote a larger reduction in pain.~Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patient able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2 , 4, 6, 8, 10), with higher score indicating more pain."|up to 21 days depending on length of hospitalization|Analysis was done based on IAD 2A population at start of study (IAD 2A: skin loss without clinical signs of infection) Note: One patient in the Cavilon Advanced Skin Protectant group and one patient in the IAD Hospital Standard care group were not able to report pain.|||Change in score on a scale||Standard Deviation|Mean
2532621|NCT03298113|Other Pre-specified|Pain Related to Product Application: IAD 1A|"Pain scores related to application of skin protectants for IAD 1A patients (Wong-Baker FACES® Pain Rating Scale). The table details the reduction in pain experienced by subjects able to report at their last recorded application event relative to baseline.~Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patient able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2 , 4, 6, 8, 10), with higher score indicating more pain."|up to 21 days depending on length of hospitalization|Analysis was done based on the IAD 1A population at start of study (IAD 1A: persistent redness without clinical signs of infection) Note: One patient allocated to IAD Hospital Standard Care was not able to report pain (n = 1 missing data set, only n= 3 data sets were available for analysis)|||Change in score on a scale||Standard Deviation|Mean
2532622|NCT03298113|Other Pre-specified|Pain Related to Cleansing: IAD 2A|"Pain scores related to clean up incontinence episode for IAD 2A patients. The table details the reduction in pain experienced by subjects able to report their last recorded cleaning event relative to baseline. More extreme negative values denote a larger reduction in pain.~Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patient able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2 , 4, 6, 8, 10), with higher score indicating more pain."|up to 21 days depending on length of hospitalization|Analysis was done based on the IAD 2A population at start of study (IAD 2A: skin loss without clinical signs of infection) Note: One patient allocated to Cavilon Advanced Skin Protectant was not able to report pain (n = 1 missing data set; only n = 6 data sets were available for analysis)|||Change in score on a scale||Standard Deviation|Mean
2532623|NCT03298113|Other Pre-specified|Pain Related to Cleansing: IAD 1A|"Pain scores related to clean up incontinence episode for IAD 1A patients. The table details the reduction in pain experienced by subjects able to report their last recorded cleaning event relative to baseline. More extreme negative values denote a larger reduction in pain. For cleansing, IAD 1A patients treated with Cavilon Advanced Skin Protectant saw no change in pain due to having no pain reported at baseline nor last visit.~Note: For this study the Wong-Baker FACES® Pain Rating Scale was used for patients able to report pain. Faces with different expressions from smiling to crying facilitated the communication as anchor for pain intensity scale (scores: 0, 2, 4, 6, 8, 10), with higher score indicating more pain."|up to 21 days depending on length of hospitalization|Analysis was done based on the IAD 1A study population at start of study (IAD 1A: persistent redness without clinical signs of infection) Note: One patient allocated to IAD Hospital Standard Care was not able to report pain (n = 1 missing data set; only n = 3 data sets were available for analysis)|||Change in score on a scale||Standard Deviation|Mean
2532624|NCT03298113|Other Pre-specified|Nursing Time Related to Product Application|Nursing time to administer skin protectants for IAD treatment|up to 21 days depending on length of hospitalization|Analysis was done based on the intention-to-treat (ITT) population Note: For two patients allocated to Cavilon Advanced Skin Protectant the nursing time to administer the skin protectant was not recorded (n = 2 missing data sets; only 8 data sets were available for analysis).|||Minutes||Standard Deviation|Mean
2532625|NCT03298113|Other Pre-specified|Nursing Time Related to Cleansing|Nursing time to clean up incontinence episode|up to 21 days depending on length of hospitalization|Analysis was done based on the intention-to-treat (ITT) population Note: One patient allocated to Cavilon Advanced Skin Protectant participated in the study for only one day. Therefore, the time required to clean up the incontinence episode could not be measured (n = 1 missing data set; only 9 data sets were available for analysis).|||Minutes||Standard Deviation|Mean
2532626|NCT03298113|Other Pre-specified|Use of Resources Involved in IAD Therapy|Additional appointments with specialists involved in IAD therapy|Up to 21 days depending on length of hospitalization|Analysis was done based on the intention-to-treat (ITT) population|||Appointments|||Number
2532627|NCT03298113|Other Pre-specified|Product Cost : IAD 2A|Mean average daily cost per patient for IAD 2A treatment based on skin protectant utilization such as type of skin protectant, frequency of application and days of treatment|up to 21 days depending on length of hospitalization|Analysis was done based on the IAD 2A population at start of study (IAD 2A: Skin loss without clinical signs of infection)|||Euro||Standard Deviation|Mean
2532628|NCT03298113|Other Pre-specified|Product Cost: IAD 1A|"Mean average daily product cost per patient for IAD 1A treatment based on skin protectant utilization such as type of skin protectant, frequency of application and days of treatment.~Note: One patient in the group treated with Cavilon Advanced Skin Protectant stayed only one day in the study due to an unrelated Severe Adverse Event at night. This had an impact on the product cost calculation. The application interval for Cavilon Advanced Skin Protectant in this study was three days (D1, D4, D7, D10, D13, D16, D19) , while the use of IAD products for standard hospital care was based on manufacturer recommendations, which could correspond to a daily interval with multiple applications."|up to 21 days depending on length of hospitalization|Analysis was done based on the IAD 1A population at start of study (IAD1A: persistent redness without clinical signs of infection).|||Euro||Standard Deviation|Mean
2562411|NCT02638337|Secondary|Change From Baseline in Follicle-Stimulating Hormone at Week 12||Baseline and Week 12|Intent-to-treat population with available data|||IU/L||Standard Deviation|Mean
2532629|NCT03298113|Other Pre-specified|Prevention of IAD Recurrence|Protection of completely healed patients from recurrence of IAD during the study.|up to 21 days depending on length of hospitalization|"The overall number of participants analyzed represents the number of patients completely healed during this study.~No healing event occured in the group treated with Cavilon Advanced Skin Protectant and therefore prevention of IAD recurrence could no be assessed. One healing event occured in the group treated with IAD Hospital Standard Care."|||IAD Recurrence Events|||Number
2532630|NCT03298113|Other Pre-specified|Prevention of Skin Loss|Protection of IAD category 1 patients from developing IAD category 2|up to 21 days depending on length of hospitalization|Analysis was done based on the IAD 1A patient population at start of study (IAD 1A: persistent redness without clinical signs of infection)|||Participants|||Count of Participants
2532631|NCT03298113|Other Pre-specified|Time to Improve in IAD Category|Time to improve in IAD category in the terms of days of treatment.|Up to 21 days depending on length of hospitalization|Analysis was done based on the intention-to-treat (ITT) population. In both treatment groups, there were two improvements in the IAD category for patients who started with IAD 2A (skin loss without clinical signs of infection) and switched to IAD 1A (persistent redness without clinical signs of infection).|||Days|Improvement Events|Standard Deviation|Mean
2532632|NCT03298113|Other Pre-specified|Time to Heal IAD|Time to complete healing of IAD in the terms of days of treatment (skin free of any IAD signs, including erythema, based on a structured skin assessment according to the GLOBIAD criteria (GLOBIAD: Ghent Global IAD Categorization Tool)|Up to 21 days depending on length of hospitalization|Analysis was done based on the intention-to-treat (ITT) population. No healing event occured in the arm/group treated with Cavilon Advanced Skin Protectant in this study.|||Days|Healing Events||Number
2532633|NCT03298113|Other Pre-specified|Re-epithelialization of Skin Loss|Number and percentage of patients with 100% re-epithelialization of skin loss based on structured skin assessment (skin loss: skin is moist, as the epidermal layer is missing).|up to 21 days depending on length of hospitalization|Analysis was done based on the IAD 2A patient population at start of study (IAD 2A: skin loss without clinical signs of infection)|||Participants|||Count of Participants
2532634|NCT03298113|Other Pre-specified|Improvement of IAD Category|Number and percentage of patients improved with regard to IAD category|Up to 21 days depending on length of hospitalization|Analysis was done based on the intention-to-treat (ITT) population. In both treatment groups, there were two improvements in the IAD category for patients who started with IAD 2A (IAD 2A: skin loss without clinical signs of infection) and switched to IAD 1A (IAD 1A: persistent redness without clinical signs of infection).|||Participants|||Count of Participants
2532635|NCT03298113|Primary|Healing of IAD|"Number and percentage of patients completely healed (skin free of any IAD signs, including erythema, based on a structured skin assessment according to the GLOBIAD criteria (GLOBIAD: Ghent Global IAD Categorization Tool)~Note: Due to the exploratory design no formal a priori hypothesis was defined for this study. The outcome measure type for all endpoints is other pre-specified. The effects were analyzed using descriptive statistics. No confirmatory statements can be made about the effects and no comparative statements are possible. The sponsor decided to early terminate the study after 20 evaluable patients for the intention-to-treat analysis. Reason for the early termination was the slow enrollment rate of patients and overall short length of stay in hospital."|up to 21 days depending on length of hospitalization|Analysis was done based on the intention-to-treat (ITT) population.|||Participants|||Count of Participants
2532636|NCT03298048|Secondary|Number of Participants With Recurrent C. Difficile Infection||6 months||||Participants|||Count of Participants
2532637|NCT03298048|Primary|Safety as Assessed by Number of Participants With Constipation||180 days||||Participants|||Count of Participants
2532638|NCT03298048|Primary|Safety as Assessed by Number of Participants With Bloating||180 days||||Participants|||Count of Participants
2532639|NCT03298048|Primary|Safety as Assessed by Number of Participants With Diarrhea||180 days||||Participants|||Count of Participants
2532640|NCT03298048|Primary|Safety as Assessed by Number of Participants With Vomiting||180 days||||Participants|||Count of Participants
2532641|NCT03298048|Primary|Safety as Assessed by Number of Participants With Nausea||180 days||||Participants|||Count of Participants
2532642|NCT03298035|Secondary|Number of Participants Who Died||until discharge (about 10 to 18 weeks) or death||||Participants|||Count of Participants
2532643|NCT03298035|Secondary|Length of Hospital Stay||about 10 to 18 weeks|One participant in the NIPPV group died; therefore, this data was not collected for that participant.|||days||Standard Deviation|Mean
2532644|NCT03298035|Secondary|Weight Gain||36 weeks corrected gestational age|Data were not collected for this outcome measure.||||||
2532645|NCT03298035|Secondary|Number of Participants With Air Leak Disorders|Air leak disorders include pneumothorax and/or pneumomediastinum.|36 weeks corrected gestational age|One participant in the NIPPV group died; therefore, this data was not collected for that participant.|||Participants|||Count of Participants
2532646|NCT03298035|Secondary|Number of Participants With Necrotizing Enterocolitis (NEC)||36 weeks corrected gestational age|One participant in the NIPPV group died; therefore, this data was not collected for that participant.|||Participants|||Count of Participants
2532647|NCT03298035|Secondary|Number of Participants With Bronchopulmonary Dysplasia (BPD)||36 weeks corrected gestational age|One participant in the NIPPV group died; therefore, this data was not collected for that participant.|||Participants|||Count of Participants
2532648|NCT03298035|Secondary|Number of Apneic Events||28 days after randomization|One participant in the NIPPV group died; therefore, this data was not collected for that participant.|||Number of apneic events||Standard Deviation|Mean
2532649|NCT03298035|Primary|Duration of Intubation||28 days after randomization||||days||Standard Deviation|Mean
2532650|NCT03298035|Primary|Number of Participants Who Were Intubated||28 days after randomization||||Participants|||Count of Participants
2532651|NCT03297944|Primary|Standard Deviation of Lane Position (SLDP)|Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane.|16 hours|All 15 participants received each intervention.|||distance (cm)||Full Range|Mean
2537967|NCT03118739|Other Pre-specified|Baseline MRI Variables - Longitudinal Strain||Baseline|Total number differs from Study totals due to subject non compliance with MRI (exam not completed)|||% (change in percentage in LV dimension)||Standard Deviation|Mean
2532652|NCT03297112|Primary|Accuracy of SHI Characterization Compared to the Risk of Malignancy Index|The ability of SHI to accurately characterize lesions as benign from malignant masses as compared to other imaging (ultrasound or MRI) and pathology will be analyzed using logistic regression and receiver operating characteristic (ROC) analyses.|Baseline scan to day of surgery||||percent accurate m lesion identification|||Number
2532653|NCT03297112|Primary|Diagnostic Accuracy of Subharmonic Ultrasound Imaging Compared to Standard Ultrasound or Contrast Enhanced Magnetic Resonance Imaging (MRI)|"The techniques will be compared using an analysis of variance (ANOVA) method (i.e., baseline ultrasound imaging, SHI, or MRI) as the dependent variable and outcome as the independent variables. Diagnostic accuracy of lesion identification as no lesion seen, definitely benign, indeterminate or definitely malignant based on independent reads by experience radiologists for SHI with and without contrast vs contrast-enhanced MRI (quantitative analysis). For qualitative analysis, digital images from the SHI imaging were reviewed by the independent radiologists for interpretation. Diagnostic accuracy reported as percentage of lesions correctly identified through SHI as compared to ultrasound or MRI as the gold standard."|Baseline scan to day of surgery||||percent accurate lesion identification|lesions||Number
2532654|NCT03296566|Secondary|Adherence to Colposcopy Treatment and Follow-up Instructions|Percentage of patients who attended follow-up at the colposcopy clinic|6 months||||percentage of participants|||Number
2532655|NCT03296566|Secondary|Patient Knowledge of Own Colposcopy Diagnosis|The percent of patients who correctly report their colposcopy pathologic diagnosis|To be collected by questionnaire in 4-6 weeks following colposcopy visit||||percentage of participants|||Number
2532656|NCT03296566|Primary|Satisfaction With Colposcopy Information and Diagnosis Education|Satisfaction with information and education received regarding colposcopy, patient diagnosis and follow-up recommendations measured by questionnaire items that measure these factors (PSQ-18 Inventory). This inventory contains 18 items assessing each of the 7 dimensions of satisfaction with medical care (general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, accessibility and convenience). Each item is scored from 1-5. Some PSQ-18 items are worded so that agreement reflects satisfaction with medical care, whereas other items are worded so that agreement reflects dissatisfaction with medical care. All items all scored so that high scores reflect satisfaction with medical care. All items are then summed; sum score of all items may range from 18 to 90 points, where 18 points is the poorest evaluation and 90 points the best.|To be collected by questionnaire in 4-6 weeks following colposcopy visit||||score on a scale||Standard Deviation|Mean
2532657|NCT03296566|Primary|Quantitative Satisfaction With Colposcopy Visit Experience Including Interactions With Colposcopy Professionals|"Patient satisfaction scores as measured by items in the questionnaire drawn from the Visit Specific Satisfaction Instrument (VSQ-9) Inventory. The VSQ-9 is a 9 item survey that measures patient satisfaction with access to primary care, with the direct interaction with the physician, and with the visit overall on a scale ranging from 1 (poor) to 5 (excellent). To score the VSQ-9, responses from each individual are transformed linearly to a 0 to 100 scale, with 100 corresponding to excellent and 0 corresponding to poor (0= Poor, 25= Fair, 50= Good, 75= Very Good, 100= Excellent). The 9 responses are then averaged together to create a VSQ-9 overall score for each person, again with 100 being the best evaluation and 0 the poorest."|To be collected by questionnaire in 4-6 weeks following colposcopy visit||||score on a scale||Standard Deviation|Mean
2532658|NCT03296566|Primary|Anxiety|"Mean state anxiety scores as measured by the State Trait Anxiety Inventory (STAI) State Subscale. The STAI has 40 items with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. Responses for the State Anxiety scale assess intensity of current feelings from 1-4 at this moment: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Item scores are added to obtain subtest total scores and for anxiety-present items, a higher score suggests higher anxiety. Scoring is reversed for anxiety-absent items (items in which a higher score suggests lower anxiety). Range of scores for the subscale is 20-80 with a higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale."|To be collected by questionnaire in 4-6 weeks following colposcopy visit||||score on a scale||Standard Deviation|Mean
2532659|NCT03296280|Secondary|Change in Barriers to Point-of-care Ultrasound Use (Skill Maintenance) From Baseline to 6-9 Months Post-Course|Change in percentage of providers who reported experiencing difficulty with maintaining POCUS skills pre-course compared to 6-9 months post-course. A positive percentage indicates more providers are experiencing this barrier post-course, which is not unexpected as more providers acquire POCUS skills.|Baseline compared to 6-9 months later.|Participants who reported at least one barrier 6-9 months after course|||percentage of participants|||Number
2532660|NCT03296280|Secondary|Change in Barrier to Point-of-care Ultrasound Use (Ability to Operate) From Baseline to 6-9 Months Post-Course|Change in percentage of providers who reported not knowing how to operate POCUS 6-9 months post-course compared to pre-course. A positive percentage indicates a better outcome post-course.|Baseline compared to 6-9 months later.|Participants who reported not knowing how to use POCUS machine in survey at the beginning of the course|||percentage of participants|||Number
2532661|NCT03296280|Secondary|Change in Point-of-care Ultrasound Abdominal Skills From Baseline to 6-9 Months|Provider hands-on abdominal skills will be tested pre- and post-intervention (at baseline [pre-course], and 6-9 months post-course). The minimum score on the POCUS Abdominal Skills scale is 0 points and the maximum is 100 points. A higher score indicates more skill. A positive change in score means a better outcome post-course (net increase in skills) compared to baseline.|Baseline compared to 6-9 months later.|Participants who completed a skills survey both at the start and about 6-9 months later were analyzed. Those who did not provide both surveys are not reported. Row populations may therefore differ from total population counts.|||change in score on Abdom Skills scale||95% Confidence Interval|Mean
2532662|NCT03296280|Secondary|Change in Point-of-care Ultrasound Peripheral IV Skills From Baseline to 6-9 Months|Provider hands-on peripheral IV skills will be tested pre- and post-intervention (at baseline [pre-course], and 6-9 months post-course). The minimum score on the POCUS Peripheral IV Skills scale is 0 points and the maximum is 100 points. A higher score indicates more skill. A positive change in score means a better outcome post-course (net increase in skills) compared to baseline.|Baseline compared to 6-9 months later.|Participants who completed a skills survey both at the start and about 6-9 months later were analyzed. Those who did not provide both surveys are not reported. Row populations may therefore differ from total population counts.|||change in score on Peri-IV Skills scale||95% Confidence Interval|Mean
2532663|NCT03296280|Secondary|Change in Point-of-care Ultrasound Lung Skills From Baseline to 6-9 Months|Provider hands-on lung skills will be tested pre- and post-intervention (at baseline [pre-course], and 6-9 months post-course). The minimum score on the POCUS Lung Skills scale is 0 points and the maximum is 100 points. A higher score indicates more skill. A positive change in score means a better outcome post-course (net increase in skills) compared to baseline.|Baseline compared to 6-9 months later.|Participants who completed a skills survey both at the start and about 6-9 months later were analyzed. Those who did not provide both surveys are not reported. Row populations may therefore differ from total population counts.|||change in score on Lung Skills scale||95% Confidence Interval|Mean
2532664|NCT03296280|Secondary|Change in Point-of-care Ultrasound Cardiac Skills From Baseline to 6-9 Months|Provider hands-on cardiac skills will be tested pre- and post-intervention (at baseline [pre-course], and 6-9 months post-course). The minimum score on the POCUS Cardiac Skills scale is 0 points and the maximum is 100 points. A higher score indicates more skill. A positive change in score means a better outcome post-course (net increase in skills) compared to baseline.|Baseline compared to 6-9 months later.|Participants who completed a skills survey both at the start and about 6-9 months later were analyzed. Those who did not provide both surveys are not reported. Row populations may therefore differ from total population counts.|||change in score on Cardiac Skills scale||95% Confidence Interval|Mean
2532665|NCT03296280|Secondary|Change in Point-of-care Ultrasound Knowledge From Baseline to 6-9 Months|Provider knowledge will be tested pre- and post-intervention (at baseline [pre-course] and 6-9 months post-course). Knowledge Exam has a minimum of 0 points and a maximum of 30 points (1 pt per question). A higher score indicates more knowledge about POCUS. A positive change in score means a better outcome post-course (net increase in knowledge) compared to baseline.|Baseline compared to 6-9 months later.|Participants who completed a knowledge survey both at the start and about 6-9 months later were analyzed. Those who did not provide both surveys are not reported. Row populations may therefore differ from total population counts.|||change in score on POCUS Knowledge scale||95% Confidence Interval|Mean
2532666|NCT03296280|Primary|Change in Frequency of Point-of-care Ultrasound Use for Diagnostic and Procedural Applications at Baseline and 6-9 Months|Provider self-reported data pre- and post-intervention on frequency of point-of-care ultrasound use, based on number of exams per week.|Baseline compared to 6-9 months later.|Participants who completed a provider survey both at the start and about 6-9 months later|||Number of POCUS Exams/week||95% Confidence Interval|Mean
2532667|NCT03296072|Secondary|EFU (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)|The EFU was measured to determine the amount of fluoride incorporation into the model erosive lesions. Each enamel specimen drilled to a depth of approximately 100 μm using a microdrill, through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then, dissolved in a known volume of perchloric acid and immediately analyzed for fluoride content using a calibrated fluoride specific electrode. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram fluoride per square centimeter (μgF/cm^2). Higher values of EFU indicate greater incorporation of fluoride into the enamel and are thus more favorable.|After 4 hrs following single exposure of treatment|The ITT population was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||Microgram fluoride per square centimeter||Standard Error|Least Squares Mean
2532668|NCT03296072|Secondary|% RER (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)|The %RER was calculated to assess the ability of treated enamel specimens to provide a combined benefit in terms of enhanced remineralization and acid resistance of the enamel. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after the second erosive challenge (E2) (E2 is measured for after both 2 and 4 hours of remineralization). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %RER was calculated as : %RER = [(E1-E2)/ (E1-B)]*100. Higher values of %RER indicate greater resistance to erosion, thus higher values are more favorable.|After 4 hrs following single exposure of treatment|The ITT population was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||Percentage RER||Standard Error|Least Squares Mean
2532669|NCT03296072|Secondary|% SMHR (Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to Comparator Containing 1100 Ppm Fluoride)|The %SMHR was calculated to assess the changes in mineralization status of enamel specimens. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after 2 and 4 hours intraoral phase (R). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %SMHR was calculated as: %SMHR = [(E1−R)/(E1−B)]*100. Greater values of %SMHR indicate that greater remineralization has occurred, thus higher values are more favorable.|After 4 hrs following single exposure of treatment|The ITT population was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||Percentage SMHR||Standard Error|Least Squares Mean
2532679|NCT03295266|Primary|Volume of Distribution (Vz) of MK-3866|Vz is the apparent volume of distribution during the terminal phase.|Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose|All treated participants with data available are included.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2532680|NCT03295266|Primary|Clearance (CL) of MK-3866|CL is the volume of plasma from which the study drug is completely removed per unit time.|Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose|All treated participants with data available are included.|||Liters/hour||Geometric Coefficient of Variation|Geometric Mean
2537968|NCT03118739|Other Pre-specified|Baseline MRI Variables - Diastolic Radial Strain Rate||Baseline|Total number differs from Study totals due to subject non compliance with MRI (exam not completed)|||s^-1||Standard Deviation|Mean
2532670|NCT03296072|Secondary|Enamel Fluoride Uptake (EFU; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Promote Fluoride Uptake in Enamel)|The EFU was measured to determine the amount of fluoride incorporation into the model erosive lesions. Each enamel specimen drilled to a depth of approximately 100 μm using a microdrill, through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then, dissolved in a known volume of perchloric acid and immediately analyzed for fluoride content using a calibrated fluoride specific electrode. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram fluoride per square centimeter (μgF/cm^2). Higher values of EFU indicate greater incorporation of fluoride into the enamel and are thus more favorable.|After 4 hrs following single exposure of treatment|The ITT population was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||Microgram fluoride per square centimeter||Standard Error|Least Squares Mean
2532671|NCT03296072|Secondary|% Relative Erosion Resistance (RER; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Inhibit Demineralization of Enamel)|The %RER was calculated to assess the ability of treated enamel specimens to provide a combined benefit in terms of enhanced remineralization and acid resistance of the enamel. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after the second erosive challenge (E2) (E2 is measured for after both 2 and 4 hours of remineralization). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %RER was calculated as : %RER = [(E1-E2)/ (E1-B)]*100. Higher values of %RER indicate greater resistance to erosion, thus higher values are more favorable.|After 4 hrs following single exposure of treatment|The ITT population was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||Percentage RER||Standard Error|Least Squares Mean
2532672|NCT03296072|Primary|% Surface Micro Hardness Recovery (SMHR; Comparison of 1150 Ppm Fluoride and 5% KNO3 Dentifrice Relative to a Fluoride Free Placebo Dentifrice to Enhance Remineralization of Enamel)|The %SMHR was calculated to assess the changes in mineralization status of enamel specimens. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after 2 and 4 hours intraoral phase (R). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %SMHR was calculated as : %SMHR = [(E1−R)/(E1−B)]*100. Greater values of %SMHR indicate that greater remineralization has occurred, thus higher values are more favorable.|After 4 hrs following single exposure of treatment|The Intent-to-Treat (ITT) population was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||Percentage SMHR||Standard Error|Least Squares Mean
2532673|NCT03295630|Secondary|Comfort of Accelerometers|"Participants were asked to rate their assessment of how comfortable the accelerometers were. They were requested to choose a statement on a five-point Likert Scale. The statements were:~Very uncomfortable~Somewhat uncomfortable~Neither comfortable nor uncomfortable~Somewhat comfortable~Very comfortable~Participants chose the most appropriate statement which they felt reflected how comfortable they found the accelerometers to wear."|Accelerometers were worn for a period not exceeding 3 hours|"Participants were asked to rate accelerometer comfort using a 5-point Likert Scale with the following statements:~'Very comfortable', 'Somewhat comfortable', 'Neither comfortable or uncomfortable', Somewhat uncomfortable', Very uncomfortable'"|||Participants|||Count of Participants
2532674|NCT03295630|Primary|Ability of an Accelerometer to Identify Step Count|Agreement between direct observation and the activity monitors (ankle and thigh placements in isolation) in determination of step count. The mean difference (95% Limits of Agreement) between observed step count and accelerometer quantified step count for the same walk were calculated. Negative values reflected an underestimation of observed step count by the accelerometer and positive values reflected an overestimation of step count.|Participants wore the accelerometers for a maximum of 3 hours, undertaking a semi-structured movement protocol|Investigation of agreement between accelerometer quantified step count (ankle and thigh in isolation) and observed step count|||Observed steps||Full Range|Mean
2532675|NCT03295266|Secondary|Number of Participants Who Discontinued the Study Due to an AE|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 days|All treated participants are included.|||Participants|||Number
2532676|NCT03295266|Secondary|Number of Participants With at Least One Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 days|All treated participants are included.|||Participants|||Number
2532677|NCT03295266|Secondary|Renal Clearance (CLr) of MK-3866|CLr is the volume of plasma from which the study drug is completely removed per unit time by the kidney (i.e., excreted into the urine). Urine samples are collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.|Predose, then pooled in the following increments: 0-4, 4-8, 8-12, 12-24 hours postdose|Urine samples were collected but were not analyzed.||||||
2532678|NCT03295266|Secondary|Fraction of Dose of MK-3866 Excreted Unchanged in Urine (Fe)|Fe is the amount of drug excreted unchanged in urine. Urine samples were collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.|Predose, then pooled in the following increments: 0-4, 4-8, 8-12, 12-24 hours postdose|Urine samples were collected but were not analyzed.||||||
2532719|NCT03294629|Secondary|90th Percentile Pressures of Auto-CPAP Machine|90th percentile pressures of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)|2 weeks||||cmH2O||Standard Deviation|Mean
2532681|NCT03295266|Primary|Apparent Terminal Half-life (t1/2) of MK-3866|Apparent t1/2 is the elimination half-life of MK-3866 from plasma.|Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose|All treated participants with data available are included.|||hours||Geometric Coefficient of Variation|Geometric Mean
2532682|NCT03295266|Primary|Time to Maximum Concentration (Tmax) of MK-3866|Tmax is the time at which the maximum plasma drug concentration is detected.|Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose|All treated participants with data available are included.|||hours||Full Range|Median
2532683|NCT03295266|Primary|Concentration at the End of Infusion (Ceoi) of MK-3866|The plasma sample collected at end-of-infusion (0.5 hours postdose) was used to determine Ceoi.|0.5 (end of infusion) hours postdose|All treated participants with data available are included.|||µM||Geometric Coefficient of Variation|Geometric Mean
2532684|NCT03295266|Primary|Area Under the Concentration-time Curve of MK-3866 From Time 0 to 24 Hours (AUC0-24hr)|AUC0-24 is determined for the period up to 24 hours post-single dose. AUC0-24 is an estimate of total daily plasma exposure from dosing to 24 hours postdose.|Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, and 24 hours postdose|All treated participants with data available are included.|||hour*µM||Geometric Coefficient of Variation|Geometric Mean
2532685|NCT03295266|Primary|Area Under the Concentration-time Curve of MK-3866 From Time 0 to Last Quantifiable Concentration (AUC0-last)|AUC0-last is determined for the period up to 72 hours post-single dose. AUC0-last is an estimate of total plasma exposure from dosing to the time of last measurable sample.|Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose|All treated participants with data available are included.|||hour*µM||Geometric Coefficient of Variation|Geometric Mean
2532686|NCT03295266|Primary|Area Under the Concentration-time Curve of MK-3866 From Time 0 to Infinity (AUC0-∞)|AUC0-∞ is determined for the period up to 72 hours post-single dose. AUC0-∞ is an estimate of total plasma exposure from dosing to (extrapolated) infinity.|Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose|All treated participants with data available are included.|||hour*µM||Geometric Coefficient of Variation|Geometric Mean
2532687|NCT03295201|Secondary|Spinal Deformity- The Modified Cobb Angle (Researcher 2)|The Modified Cobb angle was found on lateral scoliosis graphs by the angle between the superior end plate of the T4 vertebra corpus and the inferior end plate of the T12 vertebra corpus.|6 months||||degrees||Standard Deviation|Mean
2532688|NCT03295201|Secondary|Spinal Deformity- The Modified Cobb Angle (Researcher 1)|The Modified Cobb angle was found on lateral scoliosis graphs by the angle between the superior end plate of the T4 vertebra corpus and the inferior end plate of the T12 vertebra corpus.|6 months||||degrees||Standard Deviation|Mean
2532689|NCT03295201|Secondary|Spinal Deformity- The Modified Cobb Angle (Researcher 2)|The Modified Cobb angle was found on lateral scoliosis graphs by the angle between the superior end plate of the T4 vertebra corpus and the inferior end plate of the T12 vertebra corpus.|Before treatment||||degrees||Standard Deviation|Mean
2532690|NCT03295201|Secondary|Spinal Deformity- The Modified Cobb Angle (Researcher 1)|The Modified Cobb angle was found on lateral scoliosis graphs by the angle between the superior end plate of the T4 vertebra corpus and the inferior end plate of the T12 vertebra corpus.|Before treatment||||degrees||Standard Deviation|Mean
2532691|NCT03295201|Secondary|Spinal Deformity- The Cobb Angle (Researcher 2)|The Cobb angle was measured on anteroposterior scoliosis graphs by the angle between the superior end plate of the vertebra corpus where the curve begins and the end plate of the vertebra corpus which the curve ends.|6 months||||degrees||Standard Deviation|Mean
2532692|NCT03295201|Secondary|Spinal Deformity- The Cobb Angle (Researcher 1)|The Cobb angle was measured on anteroposterior scoliosis graphs by the angle between the superior end plate of the vertebra corpus where the curve begins and the end plate of the vertebra corpus which the curve ends.|6 months||||degrees||Standard Deviation|Mean
2532693|NCT03295201|Secondary|Spinal Deformity- The Cobb Angle (Researcher 2)|The Cobb angle was measured on anteroposterior scoliosis graphs by the angle between the superior end plate of the vertebra corpus where the curve begins and the end plate of the vertebra corpus which the curve ends.|Before treatment||||degrees||Standard Deviation|Mean
2532694|NCT03295201|Secondary|Spinal Deformity- The Cobb Angle (Researcher 1)|The Cobb angle was measured on anteroposterior scoliosis graphs by the angle between the superior end plate of the vertebra corpus where the curve begins and the end plate of the vertebra corpus which the curve ends.|Before treatment||||degrees||Standard Deviation|Mean
2532695|NCT03295201|Secondary|Pulmonary Function|Forced expiratory volume in 1 second (FEV1)|6 months||||millilitres||Standard Deviation|Mean
2532696|NCT03295201|Secondary|Pulmonary Function|Forced expiratory volume in 1 second (FEV1)|3 months||||millilitres||Standard Deviation|Mean
2532697|NCT03295201|Secondary|Pulmonary Function|Forced expiratory volume in 1 second (FEV1)|6 weeks||||millilitres||Standard Deviation|Mean
2532698|NCT03295201|Secondary|Pulmonary Function|Forced expiratory volume in 1 second (FEV1)|Before treatment||||millilitres||Standard Deviation|Mean
2532699|NCT03295201|Secondary|Postural Stability|The Balance Master Device- Limits of Stability Test (LOS) is used for to measure the postural stability of children. The LOS consists a 18x60 inch of a pressure platform which connected to a computer system. The patient is asked to stand on the platform barefoot and watch the image which can be moved by trunk movement on the computer the monitor. It is required to move the image towards to target points on the monitor with commands. Reaction time, movement velocity, endpoint excursion, maximum excursion and direction control parameters are calculated during these trunk movements. Reaction time (seconds) parameter is preferred to use for this study.|6 months||||seconds||Standard Error|Mean
2532700|NCT03295201|Secondary|Postural Stability|The Balance Master Device- Limits of Stability Test (LOS) is used for to measure the postural stability of children. The LOS consists a 18x60 inch of a pressure platform which connected to a computer system. The patient is asked to stand on the platform barefoot and watch the image which can be moved by trunk movement on the computer the monitor. It is required to move the image towards to target points on the monitor with commands. Reaction time, movement velocity, endpoint excursion, maximum excursion and direction control parameters are calculated during these trunk movements. Reaction time (seconds) parameter is preferred to use for this study.|3 months||||seconds||Standard Error|Mean
2532701|NCT03295201|Secondary|Postural Stability|The Balance Master Device- Limits of Stability Test (LOS) is used for to measure the postural stability of children. The LOS consists a 18x60 inch of a pressure platform which connected to a computer system. The patient is asked to stand on the platform barefoot and watch the image which can be moved by trunk movement on the computer the monitor. It is required to move the image towards to target points on the monitor with commands. Reaction time, movement velocity, endpoint excursion, maximum excursion and direction control parameters are calculated during these trunk movements. Reaction time (seconds) parameter is preferred to use for this study.|6 weeks||||seconds||Standard Error|Mean
2532702|NCT03295201|Secondary|Postural Stability|The Balance Master Device- Limits of Stability Test (LOS) is used for to measure the postural stability of children. The LOS consists a 18x60 inch of a pressure platform which connected to a computer system. The patient is asked to stand on the platform barefoot and watch the image which can be moved by trunk movement on the computer the monitor. It is required to move the image towards to target points on the monitor with commands. Reaction time, movement velocity, endpoint excursion, maximum excursion and direction control parameters are calculated during these trunk movements. Reaction time (seconds) parameter is preferred to use for this study.|Before treatment||||seconds||Standard Error|Mean
2532703|NCT03295201|Secondary|Quality of Life|The Cystic Fibrosis Questionnaire-Revised (CFQR) is used to measure the quality of life. This scale is found to be valid and reliable in Turkish. The child version of this test consists 35 questions about physical function, emotional function, social function, body appearance, eating disorders, treatment difficulties, respiratory and digestive symptoms. The total score is calculated between 0-100 and higher scores define the better condition.|6 months||||units on a scale||Standard Error|Mean
2532704|NCT03295201|Secondary|Quality of Life|The Cystic Fibrosis Questionnaire-Revised (CFQR) is used to measure the quality of life. This scale is found to be valid and reliable in Turkish. The child version of this test consists 35 questions about physical function, emotional function, social function, body appearance, eating disorders, treatment difficulties, respiratory and digestive symptoms. The total score is calculated between 0-100 and higher scores define the better condition.|3 months||||units on a scale||Standard Error|Mean
2532705|NCT03295201|Secondary|Quality of Life|The Cystic Fibrosis Questionnaire-Revised (CFQR) is used to measure the quality of life. This scale is found to be valid and reliable in Turkish. The child version of this test consists 35 questions about physical function, emotional function, social function, body appearance, eating disorders, treatment difficulties, respiratory and digestive symptoms. The total score is calculated between 0-100 and higher scores define the better condition.|6 weeks||||units on a scale||Standard Error|Mean
2532706|NCT03295201|Secondary|Quality of Life|The Cystic Fibrosis Questionnaire-Revised (CFQR) is used to measure the quality of life. This scale is found to be valid and reliable in Turkish. The child version of this test consists 35 questions about physical function, emotional function, social function, body appearance, eating disorders, treatment difficulties, respiratory and digestive symptoms. The total score is calculated between 0-100 and higher scores define the better condition.|Before treatment||||units on a scale||Standard Error|Mean
2532707|NCT03295201|Primary|Exercise Tolerance|Modified Shuttle Test (MST) is used to measure the exercise tolerance. The patient is asked to walk until feeling tired between two fixed objects with a 10-meter interval, starting at normal walking speed and increasing the speed at the beginning of each minute. Maximum distance (meters) is measured for the test.|6 months||||meters||Standard Error|Mean
2532708|NCT03295201|Primary|Exercise Tolerance|Modified Shuttle Test (MST) is used to measure the exercise tolerance. The patient is asked to walk until feeling tired between two fixed objects with a 10-meter interval, starting at normal walking speed and increasing the speed at the beginning of each minute. Maximum distance (meters) is measured for the test.|3 months||||meters||Standard Error|Mean
2532709|NCT03295201|Primary|Exercise Tolerance|Modified Shuttle Test (MST) is used to measure the exercise tolerance. The patient is asked to walk until feeling tired between two fixed objects with a 10-meter interval, starting at normal walking speed and increasing the speed at the beginning of each minute. Maximum distance (meters) is measured for the test.|6 weeks||||meters||Standard Error|Mean
2532710|NCT03295201|Primary|Exercise Tolerance|Modified Shuttle Test (MST) is used to measure the exercise tolerance. The patient is asked to walk until feeling tired between two fixed objects with a 10-meter interval, starting at normal walking speed and increasing the speed at the beginning of each minute. Maximum distance (meters) is measured for the test.|Before treatment||||meters||Standard Error|Mean
2532711|NCT03294629|Secondary|Nasal Obstruction Symptom Evaluation (NOSE)|The Nasal Obstruction Symptom Evaluation (NOSE) is a self-administered questionnaire with 11 questions. The NOSE score can range from 0 to 44, where higher scores denote a worse nasal obstruction.|2 weeks||||units on a scale||Standard Deviation|Mean
2532712|NCT03294629|Secondary|Epworth Sleepiness Score (ESS)|The ESS is a self-administered questionnaire with 8 questions. The ESS score can range from 0 to 24, where higher scores denote a worse daytime sleepiness.|2 weeks||||units on a scale||Standard Deviation|Mean
2532713|NCT03294629|Secondary|Pittsburgh Sleep Quality Index (PSQI)|The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Overall score is ranging from 0 to 21, where lower scores denote a healthier sleep quality.|2 weeks||||units on a scale||Standard Deviation|Mean
2532714|NCT03294629|Secondary|Percentage of Day Used of Auto-CPAP Machine|Percentage of day used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)|2 weeks||||Percentage of days||Standard Deviation|Mean
2532715|NCT03294629|Secondary|Time Used of Auto-CPAP Machine|Average Time used of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)|2 weeks||||minutes||Standard Deviation|Mean
2532716|NCT03294629|Secondary|Residual Apnea-Hypopnea Index (AHI)|Residual Apnea-Hypopnea index (Objective data recorded in the auto-CPAP machine) means events of apnea and hypopnea per hour during CPAP therapy.|2 weeks||||events per hour||Standard Deviation|Mean
2532717|NCT03294629|Secondary|90th Percentile Leaks of Auto-CPAP Machine|Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)|2 weeks||||liters per minute||Standard Deviation|Mean
2532718|NCT03294629|Secondary|Average Leaks of Auto-CPAP Machine|Average leaks of auto-CPAP machine (Objective data recorded in the auto-CPAP machine)|2 weeks||||liters per minute||Standard Deviation|Mean
2532723|NCT03294538|Secondary|Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups|The number of participants in the mITT Population that are identified as Treatment Success at the end of the treatment period evaluated on Day 8 ± 1 is presented. A Treatment Success is defined as a score of 0 or 1 at Day 8 ± 1 for the symptom identified at baseline as the most bothersome. This evaluation is to be based on participant self-assessed symptoms of vulvar and vaginal atrophy on a scale of 0 to 3 where 0 = none and 3 = severe. The symptoms that were evaluated were vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, and vaginal bleeding.|Up to 9 months|Participants in the PP population, administered at least 1 dose of study drug, and had a post-randomization evaluation (mITT Population). Participants who discontinued early for reasons other than efficacy were included in the mITT population using LOCF.|||Participants|||Count of Participants
2532724|NCT03294538|Secondary|Number of Participants Identified as Treatment Success After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups|The number of participants in the PP population that are identified as Treatment Success at the end of the treatment period evaluated on Day 8 ± 1 is presented. A Treatment Success is defined as a score of 0 or 1 at Day 8 ± 1 for the symptom identified at baseline as the most bothersome. This evaluation was based on participant self-assessed symptoms of vulvar and vaginal atrophy on a scale of 0 to 3 where 0 = none and 3 = severe. The symptoms that were evaluated were vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, and vaginal bleeding. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.|Up to Day 9|Participants who met I/E criteria, didn’t develop a concurrent vaginal infection, completed Day 8 visit, and took 6-8 doses and didn’t miss >1 dose of study drug (PP Population). As pre-specified in the protocol, only the active groups (Generic Estradiol Vaginal Cream USP, 0.01% and Estrace Vaginal Cream USP, 0.01%) were included in this analysis.|||Participants|||Count of Participants
2532725|NCT03294538|Primary|Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream, Estrace Vaginal Cream, and Vehicle Vaginal Cream Groups|Treatment comparison of the number of participants in the mITT population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5.|Up to Day 9|Participants in the PP population, administered at least 1 dose of study drug, and had a post-randomization evaluation (mITT Population). Participants who discontinued early for reasons other than efficacy were included in the mITT population using Last Observation Carried Forward (LOCF).|||Participants|||Count of Participants
2532726|NCT03294538|Primary|Number of Participants Identified as a Responder After Completing Study Treatment in the Generic Estradiol Vaginal Cream and Estrace Vaginal Cream Groups|Treatment comparison of the number of participants in the PP population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder.|Up to Day 9|Participants who met I/E criteria, didn’t develop a concurrent vaginal infection, completed Day 8 visit, and took 6-8 doses and didn’t miss >1 dose of study drug (PP Population). As pre-specified in the protocol, only the active groups (Generic Estradiol Vaginal Cream USP, 0.01% and Estrace Vaginal Cream USP, 0.01%) were included in this analysis.|||Participants|||Count of Participants
2532727|NCT03293485|Secondary|Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at Test of Cure Visit|The percentage of participants with cUTI who display a favorable Overall Microbiological Response at the Test of Cure visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cUTI were evaluated because the microbiological response evaluation is primarily relevant to cUTI. A favorable Overall Microbiological Response is defined as a urine culture taken at the Test of Cure visit still showing eradication (e.g., ≥10^5 CFU/mL is reduced to <10^4 CFU/mL) of all uropathogens found at study entry.|Between Day 10 and Day 23 (Test of Cure Visit)|Per protocol, the population analyzed was all participants with cUTI who received intravenous imipenem+cilastatin+relebactam ≥96 hours, whose pre-study infection-site culture grew ≥1 gram-negative and/or anaerobic pathogen, and who had no major deviations from the protocol that may substantially affect the results of the efficacy analyses.|||Percentage of Participants||95% Confidence Interval|Number
2532728|NCT03293485|Secondary|Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at Test of Cure Visit|"The percentage of participants with cIAI who display a favorable Clinical Response at the Test of Cure visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cIAI were evaluated because the clinical response evaluation is primarily relevant to cIAI. A favorable clinical response is a rating of cure as determined by the investigator at the Test of Cure Visit. Cure is defined as: all pretherapy signs and symptoms of the index infection(s) have resolved (or returned to preinfection status) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed."|Between Day 10 and Day 23 (Test of Cure Visit)|Per protocol, the population analyzed was all participants with cIAI who received intravenous imipenem+cilastatin+relebactam ≥96 hours, whose pre-study infection-site culture grew ≥1 gram-negative enteric and/or anaerobic pathogen, and who had no major deviations from the protocol that may substantially affect the results of the efficacy analyses.|||Percentage of Participants||95% Confidence Interval|Number
2532738|NCT03293394|Secondary|Change in the ALSFRS-R Score From Baseline|Change in the ALS Functional Rating Scale (ALSFRS-R) score from baseline. The ALSFRS provides a physician-generated estimate of the patient's degree of functional impairment, which can be evaluated serially to objectively assess any response to treatment or progression of disease. The ALSFRS includes ten questions that rate the patients level of functional impairment in performing one of ten common tasks. Each task is rated on a five-point scale from 0 (can't do) to 4 (normal ability). Individual item scores are summed to produce a reported score of between 40 (no impairment) and 0 (severe impairment).|Baseline - 2 weeks - 2 months - 6 months||||units on a scale||Standard Deviation|Mean
2532729|NCT03293485|Primary|Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at End of Therapy Visit|The percentage of participants with cUTI who display a favorable Overall Microbiological Response at the End of Therapy visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cUTI were evaluated because the microbiological response evaluation is primarily relevant to cUTI. A favorable Overall Microbiological Response is defined as a urine culture taken at the End of Therapy Visit showing eradication (e.g., ≥10^5 CFU/mL is reduced to <10^4 CFU/mL) of all uropathogens found at study entry.|Between Day 5 and Day 14 (End of Therapy Visit)|Per protocol, the population analyzed was all participants with cUTI who received intravenous imipenem+cilastatin+relebactam ≥96 hours, whose pre-study infection-site culture grew ≥1 gram-negative and/or anaerobic pathogen, and who had no major deviations from the protocol that may substantially affect the results of the efficacy analyses.|||Percentage of Participants||95% Confidence Interval|Number
2532730|NCT03293485|Primary|Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at End of Therapy Visit|"The percentage of participants with cIAI who display a favorable clinical response at End of Therapy visit was presented. Per protocol, a subset of the cIAI/cUTI study arm was analyzed: only participants with cIAI were evaluated because clinical response is primarily relevant to cIAI. Favorable clinical response is a rating of cure or improved as determined by the investigator at the End of Therapy Visit. Cure is defined as: all pretherapy signs and symptoms of the index infection(s) have resolved (or returned to preinfection status) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed. Improved is defined as: All or most pretherapy signs and symptoms of the index infection(s) have improved or resolved (or returned to preinfection status) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed."|Between Day 5 and Day 14 (End of Therapy Visit)|Per protocol, the population analyzed was all participants with cIAI who received intravenous imipenem+cilastatin+relebactam ≥96 hours, whose pre-study infection-site culture grew ≥1 gram-negative enteric and/or anaerobic pathogen, and who had no major deviations from the protocol that may substantially affect the results of the efficacy analyses.|||Percentage of Participants||95% Confidence Interval|Number
2532731|NCT03293485|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)|The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.|Up to 14 days (End of Therapy Visit)|Per protocol, the population analyzed was all participants who received ≥1 dose of intravenous imipenem+cilastatin+relebactam.|||Percentage of Participants||95% Confidence Interval|Number
2532732|NCT03293485|Primary|Percentage of Participants Experiencing ≥1 Adverse Events (AE)|The percentage of participants experiencing ≥1 AE was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.|Up to 28 days|Per protocol, the population analyzed was all participants who received ≥1 dose of intravenous imipenem+cilastatin+relebactam.|||Percentage of Participants||95% Confidence Interval|Number
2532733|NCT03293394|Secondary|Change Intracortical Facilitation (ICF) From Baseline|By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of tDCS on intracortical facilitation (ICF) from baseline|Baseline - 2 weeks - 2 month - 6 months||||millivolts||Standard Deviation|Mean
2532734|NCT03293394|Secondary|Change in Caregiver Burden (CBI)|"Change of quality of life from baseline evaluated with the CBI scale. The CBI scale is 24- item scale designed to assess the experience of caregivers of older people. The multidimensional instrument assesses five domains of burden (time-dependence, developmental, physical, social, and emotional). Items are scored on a 4-point scale, ranging from not at all descriptive to very descriptive. The scale ranges from 0 (no impairment) to 96 (severe impairment)."|Baseline - 2 weeks - 2 months - 6 months||||units on a scale||Standard Deviation|Mean
2532735|NCT03293394|Secondary|Change of Quality of Life From Baseline: EQ-VAS Scale|Change of quality of life from baseline evaluated with the EQ-VAS scale. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. The scale ranges from 0 (severe impairment) to 100 (no impairment).|Baseline - 2 weeks - 2 months - 6 months||||units on a scale||Standard Deviation|Mean
2532736|NCT03293394|Secondary|Change of Quality of Life From Baseline: EQ-5D-5L Scale|Change of quality of life from baseline evaluated with the EQ-5D-5L scale. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The scale ranges from 5 (no impairment) to 25 (severe impairment).|Baseline - 2 weeks - 2 months - 6 months||||units on a scale||Standard Deviation|Mean
2532737|NCT03293394|Secondary|Change of Quality of Life From Baseline: ALSAQ-40 Scale|"Change of quality of life from baseline evaluated with the ALSAQ-40 scale. The Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ) is a patient self-report health status scale. The ALSAQ is specifically used to measure the subjective well-being of patients with amyotrophic lateral sclerosis. There are 40 items/questions with 5 discrete scales: physical mobility (10 items), activities of daily living and independence (10 items), eating and drinking (3 items), communication (7 items), emotional reactions (10 items). Patients are asked to think about the difficulties they may have experienced during the last two weeks (e.g. I have found it difficult to feed myself). Patients are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale):~never/rarely/sometimes/often/always or cannot do at all. The total ranges from 0 (no impairment) to 160 (severe impairment)."|Baseline - 2 weeks - 2 months - 6 months||||units on a scale||Standard Deviation|Mean
2533577|NCT03265132|Secondary|Proportion of Patients With Sustained ACR30, ACR50, ACR70 and ACR90 Response in Relation to Glucocorticoid Tapering.|Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available.|Week 2, Week 4, Week 8 and Week 12|||||||
2532739|NCT03293394|Secondary|Change in Short-interval Intracortical Inhibition (SICI) From Baseline|By using transcranial magnetic stimulation (TMS), the investigators will evaluate the effects of tDCS on short-interval intracortical inhibition (SICI) from baseline|Baseline - 2 weeks - 2 months - 6 months||||millivolts||Standard Deviation|Mean
2532740|NCT03293394|Primary|Change in Muscle Strength From Baseline|"A megascore is obtained by summing scores of single muscles (shoulder abductors, elbow flexors and extensors, wrist flexors, thumb opponent, hip flexors, knee flexors and extensors, and ankle dorsiflexors and extensors on both sides) manually evaluated according to the Medical Research Council (MRC) scale, which ranges from 0 (no movement) to 5 (normal contraction).~The score for each muscle is summed, with scores ranging from 100 (no impairment) to 0 (most severe impairment)."|Baseline - 2 weeks - 2 months - 6 months||||units on a scale||Standard Deviation|Mean
2532741|NCT03293238|Secondary|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score|Compare the Western Ontario and McMaster Universities Osteoarthritis Index between groups at the 3-month follow-up appointment. The scale is 0-100. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|Pre-Injection and 3 month follow-up appointment following 3rd injection|Mean WOMAC score Pre-Injection and at 3-months post injection.|||units on a scale||Standard Deviation|Mean
2532742|NCT03293238|Secondary|Procedural Satisfaction Score at 3 Months Post Injection|Patient reported procedural satisfaction score on scale of 0 to 10. A score of 10 indicates high satisfaction with the procedure.|3 month follow-up appointment following 3rd injection|ANOVA|||units on a scale||Standard Deviation|Mean
2532743|NCT03293238|Primary|Number of Participants With Successful Knee Injection|To assess presence or absence of contrast medium within the target knee joint as determined by a blinded radiologist. If contrast medium could be observed in the joint then the injection was considered a success.|Procedure visit 3 (3-4 weeks after 1st injection)|Number of patients in each group with successful injections into the knee joint.|||Participants|||Count of Participants
2532744|NCT03292692|Secondary|Anxiety Symptoms|Anxiety symptoms as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7; Spitzer, Kroenke, Williams, & Löwe, 2006). The range of the measure is 0 to 49, with higher scores indicating greater anxiety symptoms. Cronbach's alpha in the present sample was .91.|Pre (0 weeks) and Post (approximately 6 weeks)||||units on a scale||Standard Deviation|Mean
2532745|NCT03292692|Secondary|Depressive Symptoms|Depressive symptoms as measured by the 10-item Center for Epidemiologic Studies-Depression (CES-D) Scale (Cole, Rabin, Smith, & Kaufman, 2004). The total score was used, with possible scores ranging from 0-30. Higher scores on this measure indicate greater depressive symptoms.|Pre (0 weeks) and Post (approximately 6 weeks)||||units on a scale||Standard Deviation|Mean
2532746|NCT03292692|Secondary|Relationship Confidence|"Relationship confidence as measured by 2 items from the Confidence Scale (I believe we can handle whatever conflicts will arise in the future and I feel good about our prospects to make this relationship work). Scored ranged from 0 to 12, with higher scores indicate more confidence.Cronbach's alpha = .88. These two items have been used in previous studies of couples to assess change (e.g., http://dx.doi .org/10.1177/0192513X08324388)."|Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)||||units on a scale||Standard Deviation|Mean
2532747|NCT03292692|Primary|Relationship Satisfaction|Relationship satisfaction as measured by the total scale on the four-item version of the Couple Satisfaction Index (Funk & Rogge, 2007; doi: 10.1037/0893-3200.21.4.572). Scores on this measure range from 0-21, with higher scores indicating greater satisfaction.|Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)||||units on a scale||Standard Deviation|Mean
2532748|NCT03292614|Primary|Evaluation of the Most Precise Method for Measuring Post-operative Refraction Following Implantation of the Asymmetric Multifocal LS-313 MF30|"After the implantation of the LS 313 MF30 (a refractive, asymmetrical, multifocal intraocular lens), the most reliable refraction method so far has been the subjective determination of far and near refraction.~A faster and widespread method is the measurement with auto-refractometers (KR-1W (TOPCON), KR-800s (TOPCON), ARK-560 (NIDEK), ARK-760A (NIDEK)) or manual refractometers (PR60/50 (Rodenstock)).~KR-1W, KR-800s, ARK-560A, ARK-760A only allow a central measurement without separate measurement of the two optical zones.~The manual refractometer PR60/50 (Rodenstock) is able to separately measure the different focal points of the multifocal lens using a light cone with 3 mm diameter.~The test device iTrace (TraceyTechnologies): is also able to separately measure the different focal points of the multifocal lens, but uses a light cone with a diameter of about 1 mm.~The results of all refractometers are compared with the subjective refraction."|one year||||diopter||Standard Deviation|Mean
2532749|NCT03292562|Secondary|Number of Participants Who Developed Air Leak Disorders|Air leak disorders include pneumothorax, pneumomediastinum, and pulmonary interstitial emphysema.|from randomization until discharge (about 92 days)||||Participants|||Count of Participants
2532750|NCT03292562|Secondary|Length of Hospital Stay||from admission to hospital until discharge (about 92 days)||||days||95% Confidence Interval|Mean
2532751|NCT03292562|Secondary|Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth||from randomization until discharge (about 92 days)||||number of days of life||95% Confidence Interval|Mean
2532752|NCT03292562|Secondary|Number of Participants Who Developed Necrotizing Enterocolitis||from randomization until discharge (about 92 days)||||Participants|||Count of Participants
2532753|NCT03292562|Secondary|Number of Participants Who Developed Bronchopulmonary Dysplasia||from randomization until discharge (about 92 days)||||Participants|||Count of Participants
2532754|NCT03292562|Secondary|Number of Participants Who Failed to Wean Off NCPAP||from randomization until discharge (about 92 days)||||Participants|||Count of Participants
2532755|NCT03292562|Secondary|Duration of Endotracheal Ventilation|Subjects might go on and off endotracheal ventilation throughout the 28 days after randomization, and the total number of days will be reported.|from randomization until 28 days post-randomization|Data for this measure was not collected.||||||
2532756|NCT03292562|Primary|Number of Days on NCPAP or Mechanical Ventilation|Subjects might go on and off NCPAP or mechanical ventilation throughout the 28 days after randomization, and the total number of days will be reported.|from randomization until 28 days post-randomization||||days||95% Confidence Interval|Mean
2533614|NCT03263806|Secondary|Hospital Length of Stay|Time from admission to discharge from hospital in days|An average of 2 days|Study terminated with NO data collected.||||||
2532757|NCT03291613|Primary|System Usability Questionnaire|"Ten likert-type questions assessing user-friendliness of technology. Each question has five answer options that range from Strongly Agree to Strongly Disagree. Scores range from 0-100. A score of 68 or above is considered above average. All scores averaged."|After 1-hour usability session||||units on a scale||Standard Deviation|Mean
2532758|NCT03291288|Secondary|Pharmacokinetic Analysis: Metabolite to Parent Ratio (MPR) for Midazolam|"Plasma samples for midazolam were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 hours (h) (±10 minutes up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).~Plasma pharmacokinetic parameters calculated for Midazolam metabolite. 1-hydroxy midazolam and midazolam for the MPR value."|Baseline to 13 days post treatment|Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population.|||Ratio||Standard Deviation|Mean
2532759|NCT03291288|Secondary|Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Midazolam Metabolite, 1-Hydroxy Midazolam|Plasma samples for midazolam and 1-hydroxy midazolam were to be collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 (±10 min up to 8 h), 10 (±2), 24 (±2), and 48 (±2) hours on Days 1 to 3 and also when co-administered with pexidartinib on Days 3 to 5 and Days 13 to 15.|Baseline to 13 days post treatment|Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population.|||ng*hour/mL||Standard Deviation|Mean
2532760|NCT03291288|Secondary|Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Midazolam Metabolite, 1-Hydroxy Midazolam|Plasma samples for midazolam and 1-hydroxy midazolam were to be collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 (±10 min up to 8 h), 10 (±2), 24 (±2), and 48 (±2) hours on Days 1 to 3 and also when co-administered with pexidartinib on Days 3 to 5 and Days 13 to 15.|Baseline to 13 days post treatment|Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population.|||hours||Full Range|Median
2532761|NCT03291288|Secondary|Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Midazolam Metabolite, 1-Hydroxy Midazolam|Plasma samples for midazolam and 1-hydroxy midazolam were to be collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 (±10 min up to 8 h), 10 (±2), 24 (±2), and 48 (±2) hours on Days 1 to 3 and also when co-administered with pexidartinib on Days 3 to 5 and Days 13 to 15.|Baseline to 13 days post treatment|Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population.|||ng/mL||Standard Deviation|Mean
2532762|NCT03291288|Secondary|Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Pexidartinib and ZAAD-1006a Metabolite|Plasma samples for pexidartinib and its metabolite were collected at predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, and 10 (±1) h after the first dose on Day 3, and at steady state when co-administered with midazolam and tolbutamide on Day 13.|Baseline to 13 days post treatment|Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population.|||ng*hour/mL||Standard Deviation|Mean
2532763|NCT03291288|Secondary|Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Pexidartinib and ZAAD-1006a Metabolite|Plasma samples for pexidartinib and its metabolite were collected at predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, and 10 (±1) h after the first dose on Day 3, and at steady state when co-administered with midazolam and tolbutamide on Day 13.|Baseline to 13 days post treatment|Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population.|||hours||Full Range|Median
2532764|NCT03291288|Secondary|Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Pexidartinib and ZAAD-1006a Metabolite|Plasma samples for pexidartinib and its metabolite were collected at predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, and 10 (±1) h after the first dose on Day 3, and at steady state when co-administered with midazolam and tolbutamide on Day 13.|Baseline to 13 days post treatment|Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population.|||ng/mL||Standard Deviation|Mean
2532765|NCT03291288|Primary|Overall Summary of Treatment-emergent Adverse Events|Adverse events that emerge during treatment, having been absent pre-treatment, or worsens relative to the pre-treatment state.|Baseline to 1 year post treatment|Treatment-emergent adverse events (TEAEs) were assessed in the Safety Analysis population.|||Participants|||Count of Participants
2532766|NCT03291288|Primary|Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Tolbutamide|Plasma samples for tolbutamide were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 h (±10 min up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).|Baseline to 15 days post treatment|Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population.|||ng*hour/mL||Standard Deviation|Mean
2532767|NCT03291288|Primary|Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Midazolam|Plasma samples for midazolam were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 hours (h) (±10 minutes up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).|Baseline to 15 days post treatment|Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population.|||ng*hour/mL||Standard Deviation|Mean
2532768|NCT03291288|Primary|Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Tolbutamide|Plasma samples for tolbutamide were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 h (±10 min up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).|Baseline to 15 days post treatment|Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population.|||hours||Full Range|Median
2532769|NCT03291288|Primary|Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Midazolam|Plasma samples for midazolam were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 hours (h) (±10 minutes up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).|Baseline to 15 days post treatment|Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population.|||hours||Full Range|Median
2532770|NCT03291288|Primary|Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Tolbutamide|Plasma samples for tolbutamide were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 h (±10 min up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).|Baseline to 15 days post treatment|Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population.|||ng/mL||Standard Deviation|Mean
2542095|NCT03008707|Primary|Short-term Morbidity||30 days|In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection|||Participants|||Count of Participants
2532771|NCT03291288|Primary|Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Midazolam|Plasma samples for midazolam were collected at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, and 48 hours (h) (±10 minutes up to 1 h, ±10% thereafter) on Days 1 to 3, and also when co-administered with pexidartinib on Days 3 (to 5) and Days 13 (to 15).|Baseline to 15 days post treatment|Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population.|||ng/mL||Standard Deviation|Mean
2532772|NCT03291197|Secondary|Inter-rater Agreement of Budapest Criteria|Investigators will assess the reproducibility of the Budapest clinical criteria for newly suspected cases of SHS. This will be achieved by determining the level of inter-rater agreement between a resident and a staff physician working in stroke rehabilitation. Investigators will thus determine if there is variability in the clinical diagnosis among physicians with different levels of expertise.|12 months||||Intraclass correlation coefficient|||Number
2532773|NCT03291197|Primary|Visual Analog Scale (VAS)|Pain scale used to address a difference following intervention. Pain is measured on a horizontal line from 0 to 100mm, with 0 being no pain and 100 being the worst imaginable pain. Participants place a vertical mark on the line indicating their pain intensity.|measured at baseline, within 1 hour after, and 2 weeks post intervention||||score on a scale||Inter-Quartile Range|Median
2532774|NCT03291197|Primary|Number of Participants Demonstrating Tolerability of Suprascapular and Median Nerve Blocks|To evaluate the tolerability of ultrasound-guided suprascapular and median nerve blocks in stroke patients with SHS as determined using the Budapest criteria. Since tolerability is a subjective measure, it will be defined by a composite outcome including: A) Pain score prior to, during, and immediately following the procedure as measured by the visual analog scale (VAS); B) the rate of serious adverse events associated with this procedure; and C) the level of patient acceptance and satisfaction as determined by a validated post-procedure survey.|12 months|All participants tolerated the intervention|||Participants|||Count of Participants
2532775|NCT03290768|Secondary|Coaching Participation Rate|(Sum of weekly coaching calls completed) / (Total number of participants*weeks)|up to 11 months||||calls per participant per week|||Number
2532776|NCT03290768|Secondary|Texting With Coaches|(Sum of all text messages) / (Total number of participants*days)|up to 11 months||||text messages per participant per day|||Number
2532777|NCT03290768|Secondary|Average Age of Participants Who Complete Trial (Yrs)|(Sum of age of patients who complete) / (Total number who complete)|up to 11 months|One of the 193 participants who completed 10 weeks of CGM use lacked age data.|||years||Standard Deviation|Mean
2532778|NCT03290768|Secondary|Average Age of Participants Who Start Trial (Yrs)|(Sum of ages of all enrollees) / (Total number of enrollees)|up to 9 months|Two of the 358 participants who started the study lacked age data.|||years||Standard Deviation|Mean
2532779|NCT03290768|Secondary|Change in Medication Dosage (mg/Day; U/Day)|(dosage of Rx on Day 180) - (dosage of Rx on Day 0)|up to 11 months|After starting the study, administrator realized that it would not be able to obtain medication data from participants. There is no data to report for this measure.||||||
2532780|NCT03290768|Secondary|Weekly Average of Estimated Glucose Values (EGV)|(Sum of EGV for a given week) / (Total number of EGV for a given week)|up to 10 weeks|358 Participants started the study, but participants dropped out as time passed. By week 10, there were only 193 participants remaining who were providing EGV.|||milligrams/deciliter||Standard Deviation|Mean
2532781|NCT03290768|Primary|Program Completion Rate (%)|(Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) * 100|up to 11 months|"Unit of measure, below, should read, percentage of participants completing 10 weeks of CGM, but there is not enough space."|||percentage of participants|||Number
2532782|NCT03290768|Primary|Program Enrollment Rate (%)|(Number of patients who were shipped devices) / (Number of patients invited to enroll) * 100|up to 9 months|Note that the number analyzed is greater than the number of participants (358) because participants are a subset of those who were invited to participate.|||percentage of invitees|||Number
2532783|NCT03290378|Primary|The Sum of Pain Intensity Differences (SPID) Through 48 Hours Post First Dose|Pain intensity was recorded using the Numerical Pain Rating Scale (NPRS) from 0 to 10, where 0 was no pain and 10 was the worst pain imaginable at hrs: .5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48. As higher pain scores indicate worse pain, a negative Pain Intensity Difference (PID) indicates less pain (improvement from baseline). Thus, SPID scores are expected to be negative if a patient's pain decreases over time, with the lower SPID values indicating greater reduction in pain intensity.|48 hours post first dose|One patient was randomized to tramadol 25 mg but received tramadol 50 mg in error.|||score on a scale||95% Confidence Interval|Least Squares Mean
2532784|NCT03290300|Primary|Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items|"This 21-item QOL scale was developed by Aerin Medical for this study to assess durability of symptom relief after treatment for nasal obstruction. Each item had 5 possible answers to convey the following responses: very positive, positive, neutral, negative and very negative. For questions 1-14, those who answered agree or agree strongly when prompted with Compared to before I had the Aerin Medical Nasal Procedure, I have experienced... were considered to have a positive response. For questions 15-18, those who answered rarely/very rarely/never when prompted with Compared to before you had the procedure, how often did you suffer from the following conditions?... were considered to have a positive response. For questions 19-21, those who answered less or much less frequently when prompted with Compared to the time prior procedure, how often have you used the following to help you with nasal congestion/difficulty breathing?... were considered to have a positive response."|36, 48, 60 months post-procedure||2022-02-28|02/2022||||
2532785|NCT03290300|Primary|Change From Baseline NOSE Score|Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome.|Baseline, 36, 48, 60 months post-procedure||2022-02-28|02/2022||||
2532844|NCT03285373|Secondary|Reason for Treatment Changes|Reason for treatment changes such as discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC.|Start of the first NOAC treatment|The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria) who required treatment changes.As per protocol this endpoint was to be analysed overall for all eligible patients who required treatment changes. Thus, this endpoint was not analysed by NOAC type.|||Participants|||Count of Participants
2532786|NCT03290300|Primary|Number and Percentage of Participants With Positive Response on Quality of Life Assessment Items|"This 21-item QOL scale was developed by Aerin Medical for this study to assess durability of symptom relief after treatment for nasal obstruction. Each item had 5 possible answers to convey the following responses: very positive, positive, neutral, negative and very negative. For questions 1-14, those who answered agree or agree strongly when prompted with Compared to before I had the Aerin Medical Nasal Procedure, I have experienced... were considered to have a positive response. For questions 15-18, those who answered rarely/very rarely/never when prompted with Compared to before you had the procedure, how often did you suffer from the following conditions?... were considered to have a positive response. For questions 19-21, those who answered less or much less frequently when prompted with Compared to the time prior procedure, how often have you used the following to help you with nasal congestion/difficulty breathing?... were considered to have a positive response."|12, 18, 24 months post-procedure|Data missing for some questions not answered by subjects.|||Participants|||Count of Participants
2532787|NCT03290300|Primary|Change From Baseline NOSE Score|Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline. The NOSE scale ranges from 0 to 100, so a maximum change from baseline would be 100 points. A positive number reported for the change from baseline indicates an improved outcome.|Baseline, 12, 18, 24 months post-procedure|The population evaluated at 12 months was 36, rather than the full 39 participants, since 3 subjects had not completed the consent process until after the 12-month post-procedure evaluation window. By the 24-month follow-up, 3 subjects had been lost to follow-up.|||units on a scale||Standard Deviation|Mean
2532788|NCT03289858|Primary|Opiate Requirements|Morphine meq given|72 hours||||Morphine mEq||95% Confidence Interval|Mean
2532789|NCT03289676|Secondary|Self-efficacy in Resisting Smoking Temptation.|This scale assesses participants' confidence (self-efficacy) in resisting smoking temptation in nine specific situations. Each item score ranges from 1 (completely unconfident) to 5 (completely confident). The scale score is the sum of each item score and ranges from 9 to 45. Higher scores represent more confidence and better outcome.|3 months||||units on the scale||Standard Deviation|Mean
2532790|NCT03289676|Primary|3-month Abstinence Rate|Participants in both arms who self-reported having not smoked a cigarette for 3 months from the quit day and also whose salivary cotinine test showed a negative result at 3-month follow-up.|3 months||||Participants|||Count of Participants
2532791|NCT03289676|Primary|Adherence Rate|Women in both arms who reported having watched all four videos of the storytelling narrative intervention.|3 months||||Participants|||Count of Participants
2532792|NCT03289481|Primary|Estimated Right Ventricular Systolic Pressure|change in estimated right ventricular systolic pressure on echo|after one week of active lozenges compared to one week of placebo lozenges||||mmHg||Full Range|Mean
2532793|NCT03289481|Primary|E/E Prime|change in E/E prime on exercise echo (E/E prime is a ratio between early mitral inflow velocity and mitral annular early diastolic velocity in order to measure diastolic dysfunction)|after one week of active lozenges compared to one week of placebo lozenges||||ratio||Full Range|Mean
2532794|NCT03289481|Primary|Metabolic Equivalents|change in metabolic equivalents on treadmill|after one week of active lozenges compared to one week of placebo lozenges||||cal/min||Full Range|Mean
2532795|NCT03289481|Primary|Time on Treadmill|change in total time traveled on treadmill|after one week of active lozenges compared to one week of placebo lozenges||||seconds||Full Range|Mean
2532796|NCT03289234|Secondary|t½||pre-dose to 48 hours post-dose|PK population|||hour||Standard Deviation|Mean
2532797|NCT03289234|Primary|AUC0-∞||pre-dose to 48 hours post-dose|PK population|||ng*hr/mL||Standard Deviation|Mean
2532798|NCT03289234|Primary|AUC0-last||pre-dose to 48 hours post-dose|PK population|||ng*hr/mL||Standard Deviation|Mean
2532799|NCT03289234|Primary|Cmax||pre-dose to 48 hours post-dose|PK population|||ng/mL||Standard Deviation|Mean
2532800|NCT03289208|Secondary|t½||pre-dose to 48 hours post-dose|PK population|||hour||Standard Deviation|Mean
2532801|NCT03289208|Primary|AUC0-∞||pre-dose to 48 hours post-dose|PK population|||ng*hr/mL||Standard Deviation|Mean
2532802|NCT03289208|Primary|AUC0-last||pre-dose to 48 hours post-dose|PK population|||ng*hr/mL||Standard Deviation|Mean
2532803|NCT03289208|Primary|Cmax||pre-dose to 48 hours post-dose|PK population|||ng/mL||Standard Deviation|Mean
2532804|NCT03288779|Secondary|Change in Gamma and Theta Oscillations as Measured by EEG||one session, approximately 30 minutes|No EEG data was collected||||||
2532805|NCT03288779|Primary|Brief Assessment of Cognition (BACS) Composite T Score|Performance on tasks included in the Brief Assessment of Cognition in Schizophrenia (BACS) battery, task performed and results recorded on IPAD. The mean change from baseline in total cognitive score on the BACS was calculated as a weighted average of T-scores (normalized for age) from BACS subtests including Verbal Memory, Digit Sequencing, Token Motor, Symbol Coding, Semantic Fluency, Letter Fluency, and Tower of London. The minimum and maximum values possible for this composite T-score of the change from baseline were -131 and 131, respectively. Higher values (positive changes from baseline) indicate better performance.|30 minutes||||Composite T- Score||95% Confidence Interval|Mean
2532806|NCT03287843|Secondary|Overall Survival|Total survival with or without disease|5 years after surgery|||||||
2532807|NCT03287843|Secondary|Disease-free Survival|Recurrence free survival|5 years after surgery|||||||
2532808|NCT03287843|Secondary|Recurrence|Both pelvic recurrence and distant metastasis will be assessed.|5 years after surgery|||||||
2532809|NCT03287843|Secondary|Surgical Complications|"Morbidity will be assessed according to the classification of Clavien-Dindo as follows:~Grade 1: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics, electrolytes, and physiotherapy. This grade also includes wound infections opened at the bedside Grade 2: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.~Grade 3: Requiring surgical, endoscopic or radiological intervention (Grade 3a: Intervention not under general anesthesia, Grade 3b: Intervention under general anesthesia) Grade 4: Life-threatening complication requiring Intensive Care Unit management (Grade 4a: Single organ dysfunction (including dialysis), Grade 4b: Multiorgan dysfunction) Grade 5 Death"|90 days after surgery||||Participants|||Count of Participants
2532810|NCT03287843|Secondary|Tumour Regression Grade|"All pathological examinations were undertaken by two experienced gastrointestinal pathologists. Pathological treatment response to neoadjuvant chemoradiotherapy was evaluated by a five-tiered system described by Mandard.~Tumor regression grade groups were identified as:~Grade 1: the absence of residual cancer Grade 2: the presence of residual cancer cells scattered throughout the fibrosis Grade 3: an increase in the number of residual cancer cells but fibrosis still predominant Grade 4: residual cancer outgrowing fibrosis Grade 5, the absence of regressive changes~Grade 1 considered as complete response. Grade 2-4 considered as partial response and Grade 5 considered as no response."|30 days after surgery||||Participants|||Count of Participants
2532811|NCT03287843|Secondary|Completeness of the Mesorectal Dissection|"Examination will be made in a fresh state for completeness of the mesorectal dissection and will be graded according to the criteria of Quirke as follows:~Low: (Grade 1) Little bulk of the mesorectum with defects down into the muscularis propria and/or very irregular circumferential resection margin.~Moderate: (Grade 2) Moderate bulk of the mesorectum but there is irregularity in the mesorectal surface. Moderate coning of the specimen toward the distal margin. At no site is the muscularis propria visible with exception of the insertion of the levator muscles. Moderate irregularity of the circumferential resection margin.~High: (Grade 3) Intact mesorectum with smooth mesorectal surface. No defect deeper than 5 mm. No coning on the specimen. Smooth circumferential resection margins on slicing."|30 days after surgery||||Participants|||Count of Participants
2532812|NCT03287843|Primary|Pathological Complete Response Rate|Complete pathological response, defined as the absence of viable tumor cells, may develop after neoadjuvant treatment for rectal cancer. Prognostic factors affecting pathological complete response will be evaluated.|2 months||||Participants|||Count of Participants
2532813|NCT03287791|Secondary|Percentage of Participants With Treatment Success Based on IGE Score|Treatment success defined as an Investigator's Global Evaluation (IGE) score at Week 12 of 0 (clear) or 1 (almost clear). Any other outcome was considered a failure. Participants who were discontinued prematurely from the study due to lack of treatment effect after at least 8 weeks of compliant treatment were considered as treatment failures. The IGE score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).|Baseline and 12 Weeks|Participants in the PP Population. Participants who did not have a valid Week 12 assessment for any other reason were excluded from the PP analysis.|||percentage of participants|||Number
2532814|NCT03287791|Primary|Percent Change From Baseline in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12|All facial papules, pustules, and nodules, located above the jaw line and extending to the hairline, were counted. When counting facial lesions, lesions present on the nose were included. The total count for each lesion type was recorded and the total number of inflammatory lesions (papules and pustules) were calculated. A papule with a pustule on its apex was counted as a pustule. Counts of nodules and cysts were reported separately and not included in the inflammatory counts. Papule defined as inflammatory lesion; small (≤5 mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule defined as inflammatory lesion; small (≤5 mm in diameter), inflamed skin swelling that is filled with pus. Cyst and nodule defined as palpable solid or soft lesion >5 mm in diameter.|Baseline, 12 weeks|Participants in the PP Population. If participant discontinued between 8 and 12 weeks of treatment due to lack of treatment, last observation carried forward (LOCF) was used to impute the number of lesions. If participant was missing Week 12 assessment for any other reason, participant was excluded.|||percent change||Standard Deviation|Mean
2532815|NCT03286283|Other Pre-specified|Proportion of Subjects With Correct Identification of 3-month Images|The proportion of subjects (i.e. percentage of treatment responders) with correct identification of 3-month images, in comparison to baseline, as determined by at least 2 out of 3 blinded Independent Photographic Reviewers.|Baseline to 3 months||||Participants|||Count of Participants
2532816|NCT03286283|Other Pre-specified|Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days)|Daily 10-point Visual Analog Scale (VAS) pain assessments following treatment through the 10 day follow-up visit by diary day with a change from the VAS pain score at baseline. The 10 day follow-up visit window was 9-14 days. Not all participants recorded their VAS score every day on the daily diary; daily diary was collected from each participant at their 10 day follow-up visit (visit window: 9-14 days).|Pre-procedure, post-procedure and Daily through 10 Day Follow-up Visit, approximately 9-14 days|Pain scores on the Visual Analog Scale (VAS) were recorded on a daily diary and analyzed out to the 10 day follow-up visit, with a visit window of 9-14 days. Not all participants recorded a VAS score for each day on the daily diary. Participants' diaries were collected at their 10 day follow-up visit.|||score on a scale||Standard Deviation|Mean
2532817|NCT03286283|Other Pre-specified|Mean Duration for Study Subject to Feel Comfortable in Public After Treatment|Mean duration for study subject to feel comfortable in public after treatment as reported by the subject|Up to 3 months||||days||Standard Deviation|Mean
2532818|NCT03286283|Other Pre-specified|Achievement of Re-epithelialization - 3 Months|Achievement of re-epithelialization by facial zone and across facial zones after treatment|3 Months|Data were not collected at 3 months since all subjects had reported 100% re-epithelization prior to 3 months.||||||
2532819|NCT03286283|Other Pre-specified|Achievement of Re-epithelialization - 1 Month|Achievement of re-epithelialization by facial zone and across facial zones after treatment|1 Month||||percentage of re-epithelialization||Standard Deviation|Mean
2532820|NCT03286283|Other Pre-specified|Achievement of Re-epithelialization - 10 Days|Achievement of re-epithelialization by facial zone and across facial zones after treatment|10 Days||||percentage of re-epithelialization||Standard Deviation|Mean
2532821|NCT03286283|Other Pre-specified|Study Subject Satisfaction at 3-month Visit|Evaluation of the subject satisfaction as reported by the subject on a visual analog scale (VAS). VAS scale ranges 0-10, 0 = best possible level of satisfaction, 10= worst possible level of satisfaction|3 Months||||score on a scale||Standard Deviation|Mean
2532822|NCT03286283|Other Pre-specified|Mean Change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) From Baseline to 3-month Follow-up Visit|Magnitude of improvement measured by the mean change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) from baseline to 3-month visit. Scale of 1 to 9 where 1 represents the lowest severity of wrinkles and 9 represents the greatest severity of wrinkles. Negative change value represents aesthetic improvement.|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
2532823|NCT03286283|Other Pre-specified|Number of Participants With an Improvement on the FWS (as Scored by Independent Reviewers) and Modified GAIS Scale (as Scored by Participants) at 3 Months|"Fitzpatrick Wrinkle and Elastosis Scale (FWS) ≥ 1-score improvement and ≥ 75% agreement with at least an improved rating by the subject on the modified Global Aesthetic Improvement Scale (GAIS) at 3 months compared to baseline. FWS Scale: Min=1, Max=9, where 1 is best and 9 is worst. The larger the difference between the baseline and 3 month scores, the greater the improvement. Modified GAIS Scale ratings: Very much improved, Much improved, Improved, No change, Worse, Much worse, and Very much worse. An improvement on the modified GAIS includes Improved, Much improved, or Very much improved."|Baseline to 3 months||||Participants|||Count of Participants
2532824|NCT03286283|Secondary|Evaluation of Pain and Discomfort|The evaluation of the pain and discomfort after treatment as reported by the subject on a 10-point visual analog scale (VAS). Mean change in VAS from baseline to 3 months. 0 = best possible level of pain and discomfort, 10= worst possible level of pain and discomfort.|Baseline to 3 months||||score on a scale||Standard Deviation|Mean
2532825|NCT03286283|Secondary|"Number of Participants With a ≥ 1-score Improvement on the Fitzpatrick Wrinkle and Elastosis Scale (FWS) and at Least an Improved Rating on the Modified Global Aesthetic Improvement Scale (GAIS) at the 3-month Visit."|"Assessment of modified Global Aesthetic Improvement Scale (GAIS) at the 3-month visit compared to baseline as assessed by the investigator. Scale ratings: Very much improved, Much improved, Improved, No change, Worse, Much worse, and Very much worse. An improvement on the modified GAIS includes Improved, Much improved, or Very much improved."|Baseline to 3 months||||Participants|||Count of Participants
2532826|NCT03286283|Primary|Adverse Event Rate and Duration|Adverse event rates, categorized by duration|Up to 3 months||||percentage of adverse events|||Number
2532827|NCT03286283|Primary|Improvement in Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score|The comparison of the proportion of subjects (i.e. percentage of treatment responders) with a ≥ 1-score improvement on the FWS at the 3-month visit, as compared to baseline as determined by at least 2 out of 3 blinded Independent Photographic Reviewers. Min=1, Max=9, where 1 is best and 9 is worst. The larger the difference between the baseline and 3 month scores, the greater the improvement.|Baseline to 3 months||||Participants|||Count of Participants
2532828|NCT03286218|Secondary|PD: Mean Scores on Drug Similarity VAS Measures|"Participants marked a point on a 100-mm horizontal line that best represented their response to the given question. The endpoints of each electronic scale were marked with descriptive anchors on a scale from 0 to 100 (Fraser et al. 1961; Bond and Lader 1974; Bigelow 1991; Shram et al. 2010). In the How similar questions, ranges from 0 to 100 and a score of 0 indicates definitely not similar, and a score of 100 indicates definitely similar."|Each Phase: 24 Hours Post Dose|All randomized participants who received at least one dose of study drug, were familiar with each listed drug on the questionnaire and had evaluable data.|||score on a scale||Standard Deviation|Mean
2532829|NCT03286218|Secondary|PD: Minimum Drug Effects (Emin) Visual Analog Scale (VAS)|Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. The scales included: Alertness/Drowsiness (I am feeling) ranges from 0 very drowsy to 100 very alert. Agitation/Relaxation (my mood is) and ranges from 0 very relaxed to 100 very agitated. Emin is derived across all postdose time points for each participant. LS Mean was calculated using the linear mixed-effects model with period, sequence and treatment as fixed effects and participant as a random effect.|Each Phase:Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose|All randomized participants who received at least one dose of study drug and had evaluable PD data, and completed the study.|||mm||Standard Error|Least Squares Mean
2532830|NCT03286218|Secondary|PD: Maximal Drug Effects (Emax) VAS (Hallucinations)|Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. The hallucinations scale is presented meaning (I am hallucinating) and ranges from 0 not at all to 100 extremely. Emax is derived as the maximum score across all postdose time points for each participant. Median and interquartile range are reported for each treatment group.|Each Phase: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose|All randomized participants who received at least one dose of study drug and had evaluable PD data, and completed the study.|||mm||Inter-Quartile Range|Median
2532831|NCT03286218|Secondary|PD: Maximal Drug Effects (Emax) Visual Analog Scale (VAS)|Drug Effects VAS Battery lists a series of measures that evaluate different effects of the abuse potential of the study drug. Scales include: Overall drug liking (overall, my liking for this drug is) and ranges from 0 definitely not to 100 definitely so. Take Drug Again (I would take this drug again) and ranges from 0 definitely not to 100 definitely so. Good effects (I can feel good drug effects) and ranges from 0 definitely not to 100 definitely so. Bad effects (I can feel bad drug effects) and ranges from 0 definitely not to 100 definitely so. High (I am feeling) and ranges from 0 not at all high to 100 extremely high. Emax is derived as the maximum score across all postdose time points for each participant. Least Square (LS) Mean is calculated using the linear mixed-effects model with period, sequence and treatment as fixed effects and participant as a random effect.|Each Phase: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5,3, 3.5, 4, 4.5, 5, 6, 8, 12, 24 Hours Post Dose|All randomized participants who received at least one dose of study drug and had evaluable PD data, and completed the study.|||mm||Standard Error|Least Squares Mean
2532832|NCT03286218|Secondary|PK: Area Under the Curve of Lasmiditan From Zero to Infinity (AUC[0-∞])|PK defined as the area under the curve of lasmiditan from zero to infinity (AUC[0-∞])|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||nanogram*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2532833|NCT03286218|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan|Pharmacokinetics (PK) defined as the maximum observed drug concentration (Cmax) of lasmiditan|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours Post Dose|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2532855|NCT03285295|Secondary|Alinity s Chagas Assay Endemics|Total of 615 specimens from subjects collected from areas known to be endemic for Chagas infection were tested with investigational Alinity s Chagas assay|10 months|Specimens from 615 subjects collected from areas known to be endemic for Chagas infection were tested with Alinity s Chagas assay per protocol.|||Participants|||Count of Participants
2532834|NCT03286218|Primary|Pharmacodynamics (PD): Maximal Effect Score (Emax) of Bipolar Drug Liking Visual Analog Scale (VAS) Scores|The Emax of Bipolar Drug Liking VAS Scores were derived as the maximum at-the-moment Drug Liking VAS score where the time to Emax was the corresponding time point at which the maximum score occurred. The bipolar Drug Liking VAS is consistent with FDA Guidance (January 2017) such that placebo should produce a score between 40 and 60 representing neutral drug-liking (ie, neither like nor dislike); a score ranging from 0 to 100 and a score of 0 indicates strong disliking, and a score of 100 indicates strong liking. Least squares mean (LS mean) was calculated using a linear mixed-effects model, including period, sequence, and treatment as fixed effects, and subject as a random effect, was used to evaluate the hypothesis tests of primary interest (at-the-moment Drug Liking) at the Emax.|Each Phase: 24 Hours|All randomized participants who received at least one dose of study drug had evaluable PD data in each of the 5 periods.|||millimeter (mm)||Standard Error|Least Squares Mean
2532835|NCT03285984|Secondary|Mean Change From Baseline (Pre-brushing to Post Brushing) in Turesky Score After Single Supervised Use for Test Products 1, 2, 3 and 4 After 4 Weeks|The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 mL of water for 10 sec,expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.|Baseline to 4 Weeks|ITT (Intent-to-treat) population was the primary analysis population, which included all the participants who were randomized and had at least one post-baseline efficacy evaluation.|||Score on a scale||Standard Deviation|Mean
2532836|NCT03285984|Primary|Mean Change From Baseline (Pre-brushing to Post-brushing) in Turesky Score After Single Supervised Use (Test Product 1 Versus [vs] Test Product 4) After 4 Weeks|The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 milliliters (mL) water for 10 seconds (sec),expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.|Baseline to 4 Weeks|ITT (Intent-to-treat) population was the primary analysis population, which included all the participants who were randomized and had at least one post-baseline efficacy evaluation.|||Score on a scale||Standard Deviation|Mean
2532837|NCT03285724|Secondary|Subject's Freedom From Serious Adverse Events Over Time|Freedom from Serious Adverse Events (SAEs) at 6 months, 12 months and 24 months follow-up shall be tracked and recorded|6 Months, 12 Months, and 24 Months|Participant did not receive the Harpoon Medical Device.||||||
2532838|NCT03285724|Secondary|Subject's Severity of Mitral Regurgitation Over Time|Severity of mitral regurgitation at 6 months, 12 months and 24 months follow-up shall be tracked and recorded|6 Months, 12 Months, and 24 Months|Participant did not receive the Harpoon Medical Device.||||||
2532839|NCT03285724|Primary|Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days|Procedure freedom from Serious Adverse Events (SAEs) during the procedure, at discharge, and at 30 days follow-up shall be tracked and recorded.|Procedure, Discharge and 30 Days||||Participants|||Count of Participants
2532840|NCT03285724|Primary|Number of Subjects With Procedural Success During the First 30 Days|"To demonstrate that the Harpoon Medical Device performs as designed and can successfully implant one or more ePTFE artificial cords on either the anterior, posterior, or both leaflets of the mitral valve via a small left thoracotomy on the beating heart and reduce mitral regurgitation from severe to less than or equal to moderate at the conclusion of the procedure and at 30 days post-procedure."|Procedure, discharge, and 30 days|Subject was not implanted with study Device|||Participants|||Count of Participants
2532841|NCT03285373|Secondary|Patient's Knowledge About His Condition|"At the time of the inclusion, the physician performed a following small questionnaire to the patients, to answer yes/no, in order to assess the patient's knowledge about his illness and the anticoagulant treatment prescribed.~Question 1. Do you know why you are being treated with an anticoagulant? Question 2. Do you know which the effect of the anticoagulant treatment is? Question 3. Do you know what could happen if you don't take the anticoagulant treatment? Question 4. Do you mind taking the anticoagulant treatment?"|single visit (Day 1)|The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.|||Participants|||Count of Participants
2532842|NCT03285373|Secondary|Duration of Previous VKA Treatment|Duration of previous VKA treatment is the time from start of the VKA treatment until stopped to start with the first NOAC|Through the observational period with an average of 43.8 months, data collected during a single visit.|The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). As per protocol this endpoint was to be analysed only for patients with previous VKA treatment (n=424). Dates of start and/or stop of previous VKA treatment were not available for 62 patients.|||Months||Standard Deviation|Mean
2532843|NCT03285373|Secondary|Number of Patients With Previous Treatment With Vitamin K Antagonists|Number of patient with Previous Treatment with Vitamin K Antagonists.|single visit (Day 1)|The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).|||Participants|||Count of Participants
2537969|NCT03118739|Other Pre-specified|Baseline MRI Variables - Diastolic Longitudinal Strain Rate||Baseline|Total number differs from Study totals due to subject non compliance with MRI (exam not completed)|||s^-1||Standard Deviation|Mean
2532845|NCT03285373|Secondary|Number of Patients Who Changed From One NOAC to a New NOAC Type and Dose|Number of patients who changed from one NOAC to a new NOAC type and dose. The treatment and its dose displayed below refer to the subsequent NOAC.|single visit (Day 1)|The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria) who changed to a new NOAC. As per protocol this endpoint was to be analysed overall for all eligible patients who changed to a new NOAC. Thus, this endpoint was not analysed by NOAC type.|||Participants|||Count of Participants
2532846|NCT03285373|Secondary|Number of Patients Who Required Discontinuing the NOAC Treatment, to Adjust the NOAC Dose or to Change to a New NOAC|Number of patients who required discontinuing the NOAC treatment, to adjust the NOAC dose or to change to a new NOAC|single visit (Day 1)|The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.|||Participants|||Count of Participants
2532847|NCT03285373|Secondary|Duration of First NOAC, All NOAC and Subsequent NOAC Treatment|Duration of NOAC treatment (First NOAC, All NOAC and Subsequent NOAC).|Through the observational period with an average of 9.4 (first NOAC), 9.6 (All NOAC) and 5.1 (Subsequent NOAC) months, data collected during a single visit.|The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.|||Months||Standard Deviation|Mean
2532848|NCT03285373|Secondary|Mean Number of Visits to the Physician Per Year|Mean number of visits to the physician per year considered for the NOAC Management.|1 year (data collected during single visit on day 1)|The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.|||visits per year||Standard Deviation|Mean
2532849|NCT03285373|Secondary|Appropriateness of NOACs Prescription|"Appropriateness of NOACs prescription based on national recommendations. For this, it was reviewed if the presence of at least one of the following clinical reason or reason related to International Normalized Ratio (INR) control were met.~Reason 1: Patients with known hypersensitivity or with specific contraindications to the use of acenocoumarol or warfarin; Reason 2: Patients with a history of intracranial hemorrhage (ICH) (except during the acute phase); Reason 3: Patients with ischemic stroke who present high-risk clinical and neuroimaging criteria for ICH; Reason 4: Patients on VKA treatment who suffer from severe arterial thromboembolic events despite good INR control; Reason 5: Patients who have started treatment with VKA in which it is not possible to maintain INR control within range (2-3) despite good therapeutic compliance; Reason 6: impossibility of access to conventional INR control; Reason 7: Other reason; Reason 8; Unknown."|single visit (Day 1)|The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). As per protocol this endpoint was to be analysed for the entire eligible patients. Thus, this endpoint was not analysed by NOAC type.|||Participants|||Count of Participants
2532850|NCT03285373|Primary|Number of Patients on Risk Based on HAS-BLED Score at the Time of the First NOAC Initiation|"Number of patients on risk (Low, Moderate and High) based on HAS-BLED Score at the time of the start of the first NOAC initiation.~The total HAS-BLED Score was stratified by category according to the following classification:~Low risk (score 0)~Moderate risk (score 1-2)~High risk (score ≥3)"|Start of the first NOAC treatment|The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 23 patients the HAS-BLED score was not available.|||Participants|||Count of Participants
2532851|NCT03285373|Primary|Usage of NOAC Based on Baseline Characteristics: HAS-BLED Score at the Time of the First NOAC Initiation|Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol (HAS-BLED Score) at the time of the start of the first NOAC initiation. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. The high scores to a great risk of bleeding and a low score corresponds to a lower risk of bleeding.|Start of the first NOAC treatment|The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 23 patients the HAS-BLED score was not available.|||unit on scale||Standard Deviation|Mean
2532852|NCT03285373|Primary|Number of Patients on Risk Based on CHA2DS2-VASc Scores at the Time of the First NOAC Initiation|"Number of patients on risk (Low, Moderate and High) based on CHA2DS2-VASc Scores at the time of the start of the first NOAC initiation.~The total CHA2DS2-VASc Scores score was stratified by category according to the following classification:~Low risk (score 0 in male; score 1 in female)~Moderate risk (score 1 in male; score 2 in female)~High risk (score ≥2 in male; score ≥3 in female)"|Start of the first NOAC treatment|The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 21 patients CHA2DS2-VASc score was not available.|||Participants|||Count of Participants
2532853|NCT03285373|Primary|Usage of NOAC Based on Baseline Characteristics: CHA2DS2-VASc Scores at the Time of the First NOAC Initiation|"Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics: Congestive heart failure, Hypertension, Age (> 75), Diabetes mellitus, Stroke/TIA, Vascular disease, Age 65-74, Sex Category (CHA2DS2-VASc Score) at the time of the start of the first NOAC initiation.~The CHA2DS2-VASc score is a clinical prediction rule to estimate the risk of stroke in patients with Atrial Fibrillation (AF); it is frequently used to determine the need for an anticoagulation therapy, relating the high scores to a great risk of stroke and a low score corresponds to a lower risk of stroke. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome."|Start of the first NOAC treatment|The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria). For 21 patients CHA2DS2-VASc score was not available.|||Unit on Scale||Standard Deviation|Mean
2532854|NCT03285373|Primary|Usage of NOAC Based on Baseline Characteristics: Age at the Time of the First NOAC Initiation|Usage of NOAC in patients diagnosed with NVAF, in the hospital setting, based on the baseline characteristics; age, at the time of the start of the first NOAC initiation.|Start of the first NOAC treatment|The analysis population consisted of all eligible patients (i.e. all patients fulfilling all inclusion criteria and no exclusion criteria).|||Years||Standard Deviation|Mean
2532856|NCT03285295|Secondary|Alinity s Anti-HBc Assay Increased Risk for HBV|Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s Anti-HBc assay.|10 months|Specimens from 403 individuals with increased risk for HBV infection were tested with Alinity s Anti-HBc assay per protocol.|||Participants|||Count of Participants
2532857|NCT03285295|Secondary|Alinity s HIV Ag/Ab Combo Assay Endemics|Total of 535 specimens from subjects collected from areas known to be endemic for HIV infection were tested with investigational Alinity s HIV Ag/Ab Combo assay.|10 months|Specimens from 535 individuals collected from areas known to be endemic for HIV infection were tested with Alinity s HIV Ag/Ab Combo assay per protocol.|||Participants|||Count of Participants
2532858|NCT03285295|Secondary|Alinity s HIV Ag/Ab Combo Assay Increased Risk of HIV-1/2|"Total of 605 specimens from subjects known to be at increased risk for HIV-1/2 infection were tested with investigational Alinity s HIV Ag/Ab Combo assay.~Sensitivity and Specificity not applicable."|10 months|Specimens from 605 individuals with increased risk for HIV-I/2 infection were tested with Alinity s HIV Ag/Ab Combo assay per protocol.|||Participants|||Count of Participants
2532859|NCT03285295|Secondary|Alinity s Anti-HCV Assay Increased Risk for HCV|Total of 407 specimens from subjects known to be at increased risk for HCV infection were tested with investigational Alinity s Anti-HCV assay.|10 months|Specimens from 407 individuals with increased risk for HCV infection were tested with Alinity s Anti-HCV assay per protocol.|||Participants|||Count of Participants
2532860|NCT03285295|Secondary|Alinity s HTLV I/II Assay Endemics|Total of 509 specimens from subjects collected from areas known to be endemic for HTLV I/II infection were tested with investigational Alinity s HTLV I/II assay. Sensitivity and Specificity not applicable.|10 months|Specimens from 509 individuals collected from areas known to be endemic for HTLV I/II infection were tested with Alinity s HTLV I/II assay per protocol.|||Participants|||Count of Participants
2532861|NCT03285295|Secondary|Alinity s HTLV Assay Increased Risk of HTLV Infection|"Total of 502 specimens from subjects known to be at increased risk for HTLV I/II infection were tested with investigational Alinity s HTLV I/II assay.~Sensitivity and Specificity not applicable."|10 months|Specimens from 502 individuals with increased risk for HTLV I/II infection were tested with Alinity s HTLV I/II assay per protocol.|||Participants|||Count of Participants
2532862|NCT03285295|Secondary|Alinity s HBsAg Assay Recovered HBV Infection|"Total of 51 specimens from subjects classified as recovered HBV infection were tested with investigational Alinity s HBsAg assay.~Sensitivity/Specificity calculation for this population not applicable."|10 months|Specimens from 51 individuals classified as recovered HBV infection were tested with Alinity s HBsAg assay per protocol.|||Participants|||Count of Participants
2532863|NCT03285295|Secondary|Alinity s HBsAg Assay Increased Risk of HBV Infection|"Total of 403 specimens from subjects known to be at increased risk for HBV infection were tested with investigational Alinity s HBsAg assay.~Sensitivity and Specificity not applicable."|10 months|Specimens from 403 individuals with increased risk for HBV infection were tested with Alinity s HBsAg assay per protocol.|||Participants|||Count of Participants
2532864|NCT03285295|Primary|Alinity s Chagas Assay Sensitivity|Total of 320 specimens from subjects known to be Chagas positive were tested with investigational Alinity s Chagas assay.|10 months|Specimens from 320 individuals known to be positive for Chagas were tested with investigational Alinity s Chagas assay per protocol.|||Participants|||Count of Participants
2532865|NCT03285295|Primary|Alinity s Chagas Assay Specificity|Total of 15804 serum and plasma specimens from whole blood donors specimens were tested with Alinity s Chagas Assay. Repeatedly reactive specimens were further tested with Alinity s Chagas and supplemental assays, if required.|10 months|All blood donor specimens tested with Alinity s Chagas assay per protocol.|||Participants|||Count of Participants
2532866|NCT03285295|Primary|Alinity s Anti-HBc Assay Sensitivity|"Total of 404 specimens from individuals with hepatitis B infection were tested with investigational Alinity s Anti-HBc assay. The population consists of the following:~Acute Hepatitis B infection n = 28 Chronic Hepatitis B infection n = 97 Recovered Hepatitis B infection n = 279"|10 months|Specimens from 404 individuals with Hepatitis B infection were tested with Alinity s Anti-HBc assay per protocol.|||Participants|||Count of Participants
2532867|NCT03285295|Primary|Alinity s Anti-HBc Assay Specificity|Total of 15877 serum and plasma specimens from whole blood donor specimens were tested with Alinity s Anti-HBc Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.|10 months|All fresh whole blood donor specimens tested with Alinity s Anti-HBc assay per protocol.|||Participants|||Count of Participants
2532868|NCT03285295|Primary|Alinity s HIV Ag/Ab Combo Assay Sensitivity|Total of 1336 specimens from subjects known to be HIV-1/2 positive were tested with Alinity s HIV Ag/Ab Combo assay.|10 months|Specimens from 1336 individuals known to be positive for HIV-1/2 were tested with Alinity s HIV Ag/Ab Combo assay per protocol.|||Participants|||Count of Participants
2532869|NCT03285295|Primary|Alinity s HIV Ag/Ab Combo Assay Specificity|Total of 16996 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HIV Ag/Ab Combo Assay. Repeatedly reactive specimens were further tested with supplemental assays, if required.|10 months|All fresh whole blood and plasmapheresis donor specimens tested with Alinity s HIV Ag/Ab Combo assay per protocol.|||Participants|||Count of Participants
2532870|NCT03285295|Primary|Alinity s Anti-HCV Assay Sensitivity|Total of 402 specimens from subjects known to be Anti-HCV positive were tested with Alinity s Anti-HCV assay.|10 months|Specimens from 402 individuals known to be positive for Anti-HCV were tested with Alinity s Anti-HCV assay per protocol.|||Participants|||Count of Participants
2532871|NCT03285295|Primary|Alinity s Anti-HCV Assay Specificity|Total of 16,999 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s Anti-HCV assay. Repeatedly reactive specimens were tested further with supplemental assays, if required.|10 months|All blood and plasmapheresis donor specimens tested with Alinity s Anti-HCV assay per protocol.|||Participants|||Count of Participants
2532872|NCT03285295|Primary|Alinity s HTLV I/II Assay Sensitivity|"Total of 706 specimens from subjects known to be HTLV positive were tested with Alinity s HTLV I/II assay. The population consists of the following:~Anti-HTLV I Positive n = 461 Anti-HTLV II positive n = 141 Anti-HTLV III positive - Undifferentiated n = 4 Individual with HTLV I/II Associated Diseases n = 100"|10 months|Specimens from 706 individuals known to be positive for HTLV were tested with Alinity s HTLV I/II assay per protocol.|||Participants|||Count of Participants
2532873|NCT03285295|Primary|Alinity s HTLV I/II Assay Specificity|Total of 15877 serum and plasma specimens from whole blood donors specimens were tested with Alinity s HTLV I/II Assay. Repeatedly reactive specimens were further tested with Alinity s HTLV I/II and supplemental assays, if required.|10 months|All blood donor specimens tested with Alinity s HTLV I/II assay per protocol.|||Participants|||Count of Participants
2532874|NCT03285295|Primary|Alinity s HBsAg and HBsAg Confirmatory Assay Sensitivity|Total of 432 specimens from subjects known to be HBsAg positive were tested with Alinity s HBsAg and HBsAg Confirmatory assay.|10 months|Specimens from 432 individuals known to be positive for HBsAg were tested with Alinity s HBsAg and HBsAg Confirmatory assay per protocol.|||Participants|||Count of Participants
2532875|NCT03285295|Primary|Alinity s HBsAg Assay Specificity|Total of 16993 serum and plasma specimens from whole blood donors as well as plasmapheresis specimens were tested with Alinity s HBsAg Assay. Repeatedly reactive specimens were further tested with Alinity s HBsAg Confirmatory and supplemental assays, if required.|10 months|All blood and plasmapheresis donor specimens tested with Alinity s HBsAg assay per protocol.|||Participants|||Count of Participants
2532876|NCT03284411|Secondary|Number of Participants Maintaining Baseline Pain as Measured on the Visual Analog Scale (VAS)|To characterize the effect of four different amplitude settings on baseline pain relief. During each follow-up period the VAS pain score was recorded once a day, on a multi-day diary, where subjects rated their pain by making a vertical slash mark through the 0-10 cm line that best described their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS pain score represented worse pain. The average VAS pain scores from the last 3 days of the diary prior to the scheduled visit was used for analysis. Each subject was considered to have maintained their baseline pain if there was less than a 2 point increase in their average pain score at the follow-up period. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained the subject's pain relief. The frequency and percentage of subjects' that maintained their average baseline VAS pain score were reported at each amplitude level.|8 weeks||||Participants|||Count of Participants
2532877|NCT03284411|Primary|SCS Therapy Satisfaction|"To characterize the effect of four different amplitude settings on baseline SCS therapy satisfaction. At each follow-up visit, the following question was asked to measure satisfaction: Overall how satisfied or unsatisfied are you with this therapy?. The response choices were as follows: very satisfied, somewhat satisfied, neutral, somewhat unsatisfied, very unsatisfied. Each subject was considered to have maintained their baseline SCS therapy satisfaction if they selected the response very satisfied, somewhat satisfied, or neutral, otherwise they were considered dissatisfied with the therapy. The first visit in which each subject reported dissatisfaction of the therapy was recorded. The amplitude used during the prior visit was then considered to be the minimum amplitude that maintained each subject's therapy satisfaction. The frequency and percentage of subjects' that maintained baseline satisfaction were reported at each amplitude level."|8 weeks||||Participants|||Count of Participants
2532878|NCT03283709|Secondary|Patient Satisfaction and Quality of Life|Change in patient satisfaction and quality of life, measured using the OHIP-14 questionnaire|60 months|The single enrolled participant did not complete the intervention; thus, no data were generated.||||||
2532879|NCT03283709|Secondary|Abutment Tooth Vitality|Loss of vitality of any abutment tooth, crowned or otherwise|60 months|The single enrolled participant did not complete the intervention; thus, no data were generated.||||||
2532880|NCT03283709|Secondary|Periodontal Disease|Change in overall score for plaque index compared to baseline presentation.|60 months|The single enrolled participant did not complete the intervention; thus, no data were generated.||||||
2532881|NCT03283709|Secondary|Periodontal Disease|Change in overall score for bleeding index compared to baseline presentation.|60 months|The single enrolled participant did not complete the intervention; thus, no data were generated.||||||
2532882|NCT03283709|Secondary|Periodontal Disease|Change in furcation classification involving any molar in either arch relative to baseline presentation..|60 months|The single enrolled participant did not complete the intervention; thus, no data were generated.||||||
2532883|NCT03283709|Secondary|Periodontal Disease|Onset of fremitus involving any tooth in either arch relative to baseline presentation.|60 months|The single enrolled participant did not complete the intervention; thus, no data were generated.||||||
2532884|NCT03283709|Secondary|Periodontal Disease|Increase or decrease in mobility involving any tooth in either arch compared to baseline presentation.|60 months|The single enrolled participant did not complete the intervention; thus, no data were generated.||||||
2532885|NCT03283709|Secondary|Periodontal Disease|Change in clinical attachment level involving any tooth in either arch compared to baseline presentation.|60 months|The single enrolled participant did not complete the intervention; thus, no data were generated.||||||
2532886|NCT03283709|Secondary|Caries|Dental caries involving any tooth in either arch|60 months|The single enrolled participant did not complete the intervention; thus, no data were generated.||||||
2532887|NCT03283709|Secondary|Tooth Loss|Loss of any nonabutment tooth in either arch for any reason|60 months|The single enrolled participant did not complete the intervention; thus, no data were generated.||||||
2532888|NCT03283709|Primary|RPD Failure|Any technical or biologic complication resulting in loss of service of RPD. This includes loss of RPD as well as dissatisfaction and nonacceptance|60 months|The single enrolled participant did not complete the intervention; thus, no data were generated.||||||
2532889|NCT03283709|Primary|RPD Abutment Tooth Loss|Loss of any RPD abutment tooth for any reason whether crowned or otherwise.|60 months|The single enrolled participant did not complete the intervention; thus, no data were generated.||||||
2532890|NCT03283709|Primary|Need to Replace Crown on RPD Abutment Tooth|This is a collective measure reporting need to replace an abutment tooth crown for any reason. This includes repeated adhesive failure at crown interface due to inadequate retention/resistance form in the abutment tooth preparation, catastrophic fracture of monolithic or veneering crown ceramic necessitating crown replacement, primary or secondary caries involving crowned abutment tooth necessitating crown replacement|60 months|The single enrolled participant did not complete the intervention; thus, no data were generated.||||||
2533517|NCT03266172|Primary|Tmax of GSK2982772 in MT Formulation: Part A|Blood samples were collected at indicated time points for analysis of Tmax.|Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose|PK Population. Only participants with data available at the specified time points were analyzed.|||Hours||Full Range|Median
2532891|NCT03283319|Secondary|Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59|Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.|Screening and Days 29, 50, 121 and 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Titers||95% Confidence Interval|Geometric Mean
2532892|NCT03283319|Secondary|Serum Microneutralization (MN) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03|Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.|Screening and Days 29, 50, 121 and 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Titers||95% Confidence Interval|Geometric Mean
2532893|NCT03283319|Secondary|Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59|Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.|Screening and Days 29, 50, 121 and 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Titers||95% Confidence Interval|Geometric Mean
2532894|NCT03283319|Secondary|Serum Microneutralization (MN) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03|Serum MN antibody titers against the H7 antigen (protein) contained in the vaccine. A higher MN titer means a better immune response to the vaccine.|Screening and Days 29, 50, 121 and 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Titers||95% Confidence Interval|Geometric Mean
2532895|NCT03283319|Secondary|Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03|Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.|Day 50|The immunogenicity full analysis population (IFAP) includes all participants who were randomized, received at least one vaccination, and had determinate assay results at any post-vaccination visit. Only participants with non-missing Day 50 results are included in this analysis.|||Titers||95% Confidence Interval|Geometric Mean
2532896|NCT03283319|Secondary|Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59|The percentage of participants obtaining seroconversion based on MN antibody titers, defined as either a prevaccination MN titer <1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a minimum 4 fold rise in postvaccination MN titer. Seroconversion represents the minimum intended effect of vaccination.|Day 29, Day 50, Day 121, Day 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Participants|||Count of Participants
2532897|NCT03283319|Secondary|Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03|The percentage of participants obtaining seroconversion based on MN antibody titers, defined as either a prevaccination MN titer <1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a minimum 4 fold rise in postvaccination MN titer. Seroconversion represents the minimum intended effect of vaccination.|Day 29, Day 50, Day 121, Day 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Participants|||Count of Participants
2532898|NCT03283319|Secondary|Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59|The percentage of participants obtaining seroconversion based on MN antibody titers, defined as either a prevaccination MN titer <1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a minimum 4 fold rise in postvaccination MN titer. Seroconversion represents the minimum intended effect of vaccination.|Day 29, Day 50, Day 121, Day 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Participants|||Count of Participants
2532899|NCT03283319|Secondary|Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59|The percentage of participants obtaining seroconversion based on HAI antibody titers, defined as either a prevaccination HAI titer <1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a minimum 4 fold rise in postvaccination HAI titer. Seroconversion represents the minimum intended effect of vaccination.|Day 29, Day 50, Day 121, Day 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Participants|||Count of Participants
2532944|NCT03283098|Secondary|Participants With Clinically-Significant Changes in Electrocardiograms (ECGs) From Baseline to End of Study|Count of participants who exhibited a clinically significant change in the results of their 12-lead electrocardiograms (ECG) when comparing baseline to end of study ECGs.|Baseline is Day -2; End of Study is Day 55|Safety Analysis set of participants with both a baseline and end of study ECG.|||Participants|||Count of Participants
2532900|NCT03283319|Secondary|Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03|The percentage of participants obtaining seroconversion based on HAI antibody titers, defined as either a prevaccination HAI titer <1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a minimum 4 fold rise in postvaccination HAI titer. Seroconversion represents the minimum intended effect of vaccination.|Day 29, Day 50, Day 121, Day 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Participants|||Count of Participants
2532901|NCT03283319|Secondary|Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59|The percentage of participants obtaining seroconversion based on HAI antibody titers, defined as either a prevaccination HAI titer <1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a minimum 4 fold rise in postvaccination HAI titer. Seroconversion represents the minimum intended effect of vaccination.|Day 29, Day 50, Day 121, Day 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Participants|||Count of Participants
2532902|NCT03283319|Secondary|Seroconversion Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03|The percentage of participants obtaining seroconversion based on HAI antibody titers, defined as either a prevaccination HAI titer <1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a minimum 4 fold rise in postvaccination HAI titer. Seroconversion represents the minimum intended effect of vaccination.|Day 29, Day 50, Day 121, Day 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Participants|||Count of Participants
2532903|NCT03283319|Secondary|Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant MF59|The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer >= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.|Screening, Day 29, Day 121, Day 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Participants|||Count of Participants
2532904|NCT03283319|Secondary|Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Hong Kong Strain for Participants Given Adjuvant AS03|The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer >= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.|Screening, Day 29, Day 121, Day 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Participants|||Count of Participants
2532905|NCT03283319|Secondary|Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59|The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer >= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.|Screening, Day 29, Day 121, Day 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Participants|||Count of Participants
2532906|NCT03283319|Secondary|Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03|The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer >= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.|Screening, Day 29, Day 121, Day 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Participants|||Count of Participants
2532907|NCT03283319|Secondary|Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59|Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.|Day 50|The immunogenicity full analysis population (IFAP) includes all participants who were randomized, received at least one vaccination, and had determinate assay results at any post-vaccination visit. Only participants with non-missing Day 50 results are included in this analysis.|||Titers||95% Confidence Interval|Geometric Mean
2533006|NCT03281200|Secondary|The Clinical Baseline Characteristics - Percentage of Patients With Emphysema|The percentage of patients with emphysema at the start of treatment with nintedanib (OFEV®) is presented.|From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.|All enrolled patients who met the selection criteria.|||Percentages of Patients|||Number
2532908|NCT03283319|Secondary|Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59|Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.|Screening and Days 29, 50, 121 and 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Titers||95% Confidence Interval|Geometric Mean
2532909|NCT03283319|Secondary|Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03|Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.|Day 50|The immunogenicity full analysis population (IFAP) includes all participants who were randomized, received at least one vaccination, and had determinate assay results at any post-vaccination visit. Only participants with non-missing Day 50 results are included in this analysis.|||Titers||95% Confidence Interval|Geometric Mean
2532910|NCT03283319|Secondary|Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03|Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.|Screening and Days 29, 50, 121 and 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Titers||95% Confidence Interval|Geometric Mean
2532911|NCT03283319|Secondary|Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59|Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.|Day 50|The immunogenicity full analysis population (IFAP) includes all participants who were randomized, received at least one vaccination, and had determinate assay results at any post-vaccination visit. Only participants with non-missing Day 50 results are included in this analysis.|||Titers||95% Confidence Interval|Geometric Mean
2532912|NCT03283319|Secondary|Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant MF59|Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.|Screening and Days 29, 50, 121 and 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Titers||95% Confidence Interval|Geometric Mean
2532913|NCT03283319|Secondary|Seroconversion Based on Serum Microneutralization (MN) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03|The percentage of participants obtaining seroconversion based on MN antibody titers, defined as either a prevaccination MN titer <1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a minimum 4 fold rise in postvaccination MN titer. Seroconversion represents the minimum intended effect of vaccination.|Days 29, 50, 121, and 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Participants|||Count of Participants
2532914|NCT03283319|Secondary|Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59|The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer >= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.|Day 50|The immunogenicity full analysis population (IFAP) includes all participants who were randomized, received at least one vaccination, and had determinate assay results at any post-vaccination visit. Only participants with non-missing Day 50 results are included in this analysis.|||Participants|||Count of Participants
2532915|NCT03283319|Secondary|Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Guangdong Strain for Participants Given Adjuvant AS03|Serum HAI antibody titers against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine.|Screening and Days 29, 50, 121 and 212|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Titers||95% Confidence Interval|Geometric Mean
2532916|NCT03283319|Secondary|Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03|The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer >= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.|Day 50|The immunogenicity full analysis population (IFAP) includes all participants who were randomized, received at least one vaccination, and had determinate assay results at any post-vaccination visit. Only participants with non-missing Day 50 results are included in this analysis.|||Participants|||Count of Participants
2532945|NCT03283098|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs) of Interest|Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. Narrow search criteria used for both standardized MedDRA queries (SMQ) and events of interest (EOI). One preferred term (PT) could match multiple EOIs. Infusion Reaction EOI counts included only those events which had onset day coinciding with study medication infusion and resolved on the same day or the day after onset.|Day 1 up to Day 55 (end of study)|Safety Analysis Set|||Participants|||Count of Participants
2562412|NCT02638337|Secondary|Change From Baseline in Estradiol at Week 12||Baseline and Week 12|Intent-to-treat population with available data|||pg/mL||Standard Deviation|Mean
2532917|NCT03283319|Secondary|Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59|The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer >= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.|Day 50|The immunogenicity full analysis population (IFAP) includes all participants who were randomized, received at least one vaccination, and had determinate assay results at any post-vaccination visit. Only participants with non-missing Day 50 results are included in this analysis.|||Participants|||Count of Participants
2532918|NCT03283319|Secondary|Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03|The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer >= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.|Day 50|The immunogenicity full analysis population (IFAP) includes all participants who were randomized, received at least one vaccination, and had determinate assay results at any post-vaccination visit. Only participants with non-missing Day 50 results are included in this analysis.|||Participants|||Count of Participants
2532919|NCT03283319|Secondary|Treatment-emergent Unsolicited Adverse Events for Participants Given Adjuvant MF59|Count of participants who experienced at least one unsolicited adverse event (i.e. adverse events not included in the solicited local and systemic adverse event list nor considered a serious AE, MAAE or PIMMC) that occur post-vaccination.|Day 1 through Day 50|Safety population includes all participants who received any amount of study vaccination.|||Participants|||Count of Participants
2532920|NCT03283319|Secondary|Treatment-emergent Unsolicited Adverse Events for Participants Given Adjuvant AS03|Count of participants who experienced at least one unsolicited adverse event (i.e. adverse events not included in the solicited local and systemic adverse event list nor considered a serious AE, MAAE or PIMMC ) that occur post-vaccination.|Day 1 through Day 53, which is the upper window of the Day 50 visit|Safety population includes all participants who received any amount of study vaccination.|||Participants|||Count of Participants
2532921|NCT03283319|Secondary|Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) for Participants Given Adjuvant MF59|Count of participants who experienced at least one medical condition that was potentially immune mediated occurring post-vaccination|Day 1 through Day 394|Safety population includes all participants who received any amount of study vaccination.|||Participants|||Count of Participants
2532922|NCT03283319|Secondary|Treatment-emergent Potentially Immune Mediated Medical Conditions (PIMMCs) for Participants Given Adjuvant AS03|Count of participants who experienced at least one medical condition that was potentially immune mediated occurring post-vaccination|Day 1 through Day 394|Safety population includes all participants who received any amount of study vaccination.|||Participants|||Count of Participants
2532923|NCT03283319|Secondary|Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant MF59|Count of participants who experienced at least one adverse event that requires a visit to medical personnel, including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason occurring post-vaccination.|Day 1 through Day 394|Safety population includes all participants who received any amount of study vaccination.|||Participants|||Count of Participants
2532924|NCT03283319|Secondary|Treatment-emergent Medically Attended Adverse Events (MAAEs) for Participants Given Adjuvant AS03|Count of participants who experienced at least one adverse event that requires a visit to medical personnel, including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason occurring post-vaccination.|Day 1 through Day 394|Safety population includes all participants who received any amount of study vaccination.|||Participants|||Count of Participants
2532925|NCT03283319|Secondary|Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant MF59|Count of participants who experienced at least one serious adverse event|Day 1 through Day 394|Safety population includes all participants who received any amount of study vaccination.|||Participants|||Count of Participants
2532926|NCT03283319|Secondary|Treatment-emergent Serious Adverse Events (SAEs) for Participants Given Adjuvant AS03|Count of participants who experienced at least one serious adverse event|Day 1 through Day 394|Safety population includes all participants who received any amount of study vaccination.|||Participants|||Count of Participants
2532927|NCT03283319|Primary|Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant MF59|The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer >= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.|Day 50|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Participants|||Count of Participants
2532928|NCT03283319|Primary|Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against the Hong Kong Strain for Participants Given Adjuvant AS03|The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer >= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.|Day 50|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Participants|||Count of Participants
2533518|NCT03266172|Primary|Time to Cmax (Tmax) of GSK2982772 in IR Formulation: Part A|Blood samples were collected at indicated time points for analysis of Tmax.|Pre-dose 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose|PK Population|||Hours||Full Range|Median
2532929|NCT03283319|Primary|Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant MF59|The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer >= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.|Day 50|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Participants|||Count of Participants
2532930|NCT03283319|Primary|Seroprotection Based on Serum Hemagglutination-inhibition (HAI) Antibody Titers Against Guangdong Strain for Participants Given Adjuvant AS03|The percentage of participants achieving seroprotection, defined as a serum HAI antibody titer >= 1:40 against the H7 antigen (protein) contained in the vaccine. A higher HAI titer means a better immune response to the vaccine. A titer of 1:40 or greater is considered to be a sufficient amount of antibody to avoid influenza infection in half of exposed individuals.|Day 50|Immunogenicity Per Protocol Population (IPPP) includes all participants who received a full dose of vaccine at Days 1 and 29 as assigned by randomization within protocol visit windows, had determinate assay results at Day 50 within protocol visit window, and had no major protocol deviations that may have an impact on immunogenicity assessments|||Participants|||Count of Participants
2532931|NCT03283319|Primary|Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant MF59|"Count of participants who experienced at least one of the following during at least one of the time frames specified:~Solicited systemic reactions include fever, myalgia (muscle pain), arthralgia (joint pain), fatigue, headache, nausea, vomiting, diarrhea, and chills."|Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)|Safety population includes all participants who received any amount of study vaccination.|||Participants|||Count of Participants
2532932|NCT03283319|Primary|Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant MF59|"Count of participants who experienced at least one of the following during at least one of the time frames specified:~Solicited local reactions at the injection site: erythema/redness, induration/swelling, and pain"|Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)|Safety population includes all participants who received any amount of study vaccination.|||Participants|||Count of Participants
2532933|NCT03283319|Primary|Solicited Systemic Reactogenicity Symptoms for Participants Given Adjuvant AS03|"Count of participants who experienced at least one of the following during at least one of the time frames specified:~Solicited systemic reactions include fever, myalgia (muscle pain), arthralgia (joint pain), fatigue, headache, nausea, vomiting, diarrhea, and chills."|Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)|Safety population includes all participants who received any amount of study vaccination.|||Participants|||Count of Participants
2532934|NCT03283319|Primary|Solicited Local Reactogenicity Symptoms for Participants Given Adjuvant AS03|"Count of participants who experienced at least one of the following during at least one of the time frames specified:~Solicited local reactions at the injection site: erythema/redness, induration/swelling, and pain"|Day 1-8, Day 29-36 (within 8 days of each vaccination, inclusive of the vaccination day)|Safety population includes all participants who received any amount of study vaccination.|||Participants|||Count of Participants
2532935|NCT03283098|Secondary|Participants With Anti-etelcalcetide Antibody at Baseline and Postbaseline|Participants with positive titers for antibodies to etelcalcetide could be asked to return to the clinical research unit to provide additional serum samples.|Baseline: Day 1 prior to dialysis. Postbaseline: Days 29 and 55 prior to dialysis|Safety Analysis set|||Participants|||Count of Participants
2532936|NCT03283098|Secondary|Change From Baseline to End of Study in Serum Phosphorus|Serum phosphorus was tested at a central laboratory.|Baseline is Day 1 prior to dialysis; End of Study is Day 55|Safety Analysis set|||mmol/L||Standard Deviation|Mean
2532937|NCT03283098|Secondary|Baseline and Change From Baseline to End of Study in Serum Albumin|Serum albumin was tested at a central laboratory.|Baseline is the average of Day -2 and Day 1 prior to dialysis; End of Study is Day 55|Safety Analysis set|||g/dL||Standard Deviation|Mean
2532938|NCT03283098|Secondary|Participants With Low Corrected Calcium (cCA) By Category|"The lowest cCA value for each participant is reported.~Total serum calcium was corrected if the serum albumin was < 4 g/dL or 40 g/L, otherwise cCa equals total serum calcium.~The correction formula was:~Corrected calcium (mg/dL) = Total calcium (mg/dL) + (4 - albumin [g/dL]) * 0.8"|Timeframes: Days 8, 15, 22, 27, 29, 34, 41, 55|Safety Analysis set|||Participants|||Count of Participants
2532939|NCT03283098|Secondary|Change From Baseline to End of Study in Corrected Calcium (cCa)|"Total serum calcium was corrected if the serum albumin was < 4 g/dL or 40 g/L, otherwise cCa equals total serum calcium.~The correction formula was:~Corrected calcium (mg/dL) = Total calcium (mg/dL) + (4 - albumin [g/dL]) * 0.8"|Baseline is the average of Day -2 and Day 1 prior to dialysis; End of Study is Day 55|Safety Analysis set|||mmol/L||Standard Deviation|Mean
2532940|NCT03283098|Secondary|Change From Baseline to End of Study in Calcium|Calcium was tested at a central laboratory.|Baseline is Day 1 prior to dialysis; End of Study is Day 55|Safety Analysis set|||mmol/L||Standard Deviation|Mean
2532941|NCT03283098|Secondary|Baseline and Change From Baseline to End of Study in Heart Rate|Participants remained seated for at least 10 minutes prior to measurement of predialysis heart rate and blood pressure.|Baseline Day 1 prior to dialysis; End of Study is Day 55|Safety Analysis set|||beats/minute||Standard Deviation|Mean
2532942|NCT03283098|Secondary|Change From Baseline to End of Study in Systolic and Diastolic Blood Pressures|Participants remained seated for at least 10 minutes prior to measurement of predialysis heart rate and blood pressure.|Baseline Day 1 prior to dialysis; End of Study is Day 55|Safety Analysis set|||mmHg||Standard Deviation|Mean
2532943|NCT03283098|Secondary|Change From Baseline to End of Study in Weight|Change from baseline in weight measured at visit.|Day 1 up to Day 55|Safety Analysis set|||kg||Standard Deviation|Mean
2533569|NCT03265132|Secondary|Time to Study Drug Discontinuation Due to Lack of Efficacy or Progressive Disease.|Proportion of study drug discontinuation due to lack of efficacy or progressive disease was analyzed using Kaplan-Meier curves. Number of patients discontinuing study drug due to lack of efficacy or progressive disease is reported here.|From Day 1 to Week12||||Participants|||Count of Participants
2532946|NCT03283098|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|"The severity of each adverse event was assessed using the NCI-CTCAE Version 4.0 according to the following:~Grade 1 - Mild: Asymptomatic or mild symptoms; intervention not indicated~Grade 2 - Moderate: Minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL)~Grade 3 - Severe: Medically significant but not life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL~Grade 4 - Life-threatening~Grade 5 - Fatal.~A serious AE is an AE that met one or more of the following criteria:~Death~Life-threatening~Required inpatient hospitalization or prolongation of an existing hospitalization~Resulted in persistent or significant disability/incapacity~A congenital anomaly/birth defect~Important medical events that required medical or surgical intervention to prevent one of the outcomes above."|Day 1 up to Day 55 (end of study)|Safety Analysis set containing all participants who received at least 1 dose of investigational product (IP)|||Participants|||Count of Participants
2532947|NCT03283098|Primary|Pharmacokinetic (PK) Parameter: Accumulation Ratio Comparing Days 1 and 27|Accumulation ratio, calculated as AUClast day 27/AUClast day 1.|Days 1 and 27; PK blood sampling predialysis, and up to 44-50 hour postdose.at 10, 30, 60, 90 min postdose: Day 2 and 28 between 18 and 30 hours after study drug administration; Day 3 (predialysis) + Day 29|Pharmacokinetic concentration analysis set|||ratio||Standard Deviation|Mean
2532948|NCT03283098|Primary|Pharmacokinetic (PK) Parameter: Area Under the Curve From Time Zero to the Beginning of the Subsequent Hemodialysis Treatment (AUClast) of Plasma Etelcalcetide on Days 1 and 27|AUClast was specifically defined in this study as the area under the concentration time curve measured from the time of drug administration to the beginning of the next dialysis session, following the first and last dose.|Days 1 and 27; PK blood sampling predialysis, and up to 44-50 hour postdose.at 10, 30, 60, 90 min postdose: Day 2 and 28 between 18 and 30 hours after study drug administration; Day 3 (predialysis) + Day 29|Pharmacokinetic concentration analysis set|||hour*ng/mL||Standard Deviation|Mean
2532949|NCT03283098|Primary|PK: Maximum Observed Drug Concentration (Cmax) of Plasma Etelcalcetide on Days 1 and 27|Cmax was defined as the maximum observed plasma drug concentration measured between the time of drug administration to the beginning of the next dialysis session.|Days 1 and 27; PK blood sampling predialysis, and at 10, 30, 60, 90 min postdose, as well as on Day 2 and 28 between 18 and 30 hours after study drug administration|Pharmacokinetic concentration analysis set|||ng/mL||Standard Deviation|Mean
2532950|NCT03283098|Primary|Pharmacokinetic (PK) Parameter: Time to Maximum Drug Concentration (Tmax) of Plasma Etelcalcetide on Days 1 and 27|Tmax is the time to maximum drug concentration of plasma etelcalcetide after dosing on Days 1 and 27.|Days 1 and 27; PK blood sampling predialysis, and at 10, 30, 60, 90 min postdose, as well as on Day 2 and 28 between 18 and 30 hours after study drug administration|Pharmacokinetic Concentration Analysis Set: all participants who received at least 1 dose of etelcalcetide and had at least 1 pharmacokinetic sample collected.|||hour||Full Range|Median
2532951|NCT03282591|Secondary|Change From Baseline in Cough Severity Visual Analog Scale (VAS)|Visual Analog Scale (VAS) 101-point scale ranging from 0 (no cough) to 100 (worst cough). A higher score corresponds to higher cough severity.|from Baseline to Day 84||||units on a scale||90% Confidence Interval|Least Squares Mean
2532952|NCT03282591|Secondary|Percentage of Participants With ≥30% Reduction in Awake Objective Cough Frequency|The percentage of participants with ≥ 30% of reduction from baseline in the awake cough frequency is the number of participants with ≤30% change in awake cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).|from Baseline to Day 84||||percentage of participants|||Number
2532953|NCT03282591|Secondary|Percentage of Participants With ≥ 30% Reduction in 24-hour Objective Cough Frequency|The percentage of participants with ≥ 30% of reduction from baseline in 24-hour cough frequency is the number of participants with ≤-30% change in 24-hour cough frequency divided by the total number of participants with available data. This data is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).|from Baseline to Day 84||||Percentage of participants|||Number
2532954|NCT03282591|Secondary|Change in Awake Objective Cough Frequency|Awake cough frequency = (total number of cough events during the monitoring period (24-hour interval) the subject is awake)/(Total duration (in hours) for the monitoring period the subject is awake) which is captured by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).|from Baseline to Day 84||||coughs/hr||90% Confidence Interval|Least Squares Mean
2532955|NCT03282591|Primary|Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo)|Change in 24-hour objective cough frequency is total number of cough events during the monitoring period (24-hour interval)/24 (Total duration (in hours) for the monitoring period) which is captured through sound recordings by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).|from Baseline to Day 84||||coughs/hr||Standard Error|Least Squares Mean
2532956|NCT03282240|Secondary|Number of Participant With Serious Adverse Event|An serious adverse event was any untoward medical occurrence that at any dose results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity,is a congenital anomaly/birth defect, or was an important medical event.|Up to 6 months after vaccination|Analysis was performed on safety analysis set.|||Participants|||Count of Participants
2532957|NCT03282240|Secondary|Number of Participant With Unsolicited Adverse Event (AE)|An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.|Within 28 days after vaccination|Analysis was performed on safety analysis set.|||Participants|||Count of Participants
2533004|NCT03281200|Secondary|The Clinical Baseline Characteristics - Percentage of Patients With UIP Radiological Pattern|The UIP radiological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.|From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.|All enrolled patients who met the selection criteria.|||Percentages of Patients|||Number
2532958|NCT03282240|Secondary|Number of Participants With Immediate Adverse Event (AEs)|Participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurring during that time was recorded as immediate unsolicited systemic AEs (AEs that were related to the investigational product) in the case report book (CRB). Unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/ or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.|Within 30 minutes after vaccination|Analysis was performed on safety analysis set.|||Participants|||Count of Participants
2532959|NCT03282240|Secondary|Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine|Solicited injection site: Pain, Erythema, Swelling, Induration, and Bruising. Grade 3 reactions: Pain - interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention; Erythema, Swelling, Induration, and Bruising: >100 millimeters (mm). Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 reactions: Fever: >=39°C; Headache, Malaise, Myalgia, and Shivering: interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.|Within 7 days after vaccination|Analysis was performed on safety analysis set that included all participants who had received study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Here, ‘number analyzed’ = participants with available data for each specified category.|||Participants|||Count of Participants
2532960|NCT03282240|Secondary|Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28|Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Detectable neutralization antibody titer >= 1:10 (1/dilution) at Day 0 and Day 28.|Day 0, Day 28|Analysis was performed on expanded immunogenicity subset. Here, ‘number analyzed’ = participants with available data for each category.|||Participants|||Count of Participants
2532961|NCT03282240|Secondary|Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28|Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). 2-fold and 4-fold rise was defined as the computed value = post-vaccination computed value / baseline computed value.|Day 28|Analysis was performed on expanded immunogenicity subset. Here, ‘overall number of participants analyzed’ = participants with available data for this outcome measure.|||Participants|||Count of Participants
2532962|NCT03282240|Secondary|Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28|Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Neutralizing antibody was defined as titers >=20 (1/dilution), >=40 (1/dilution), >=80 (1/dilution) at Day 0 and Day 28.|Day 0, Day 28|Analysis was performed on expanded immunogenicity subset.|||Participants|||Count of Participants
2532963|NCT03282240|Secondary|GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine|GMTRs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Analysis was performed on expanded immunogenicity subset. Here, ‘number analyzed’ = participants with available data for each category.|||ratio||95% Confidence Interval|Number
2532964|NCT03282240|Secondary|Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine|GMTs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Expanded immunogenicity subset:participants who received at least 1 dose of trial vaccine& had post-vaccination blood sample HAI result for at least 1 strain& were randomized into expanded immunogenicity subset with at least 1 post-vaccination SN assay result for at least 1 strain.'Number analyzed’=participants with available data for each category|||titers (1/dilution)||95% Confidence Interval|Geometric Mean
2532965|NCT03282240|Secondary|Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine|Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). Seroprotection was defined as a HAI titer >=40 (1/dilution) at Day 0 and Day 28.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Analysis was performed on PPAS. Here, ‘number analyzed’ = participants with available data for each category.|||percentage of participants||95% Confidence Interval|Number
2532966|NCT03282240|Secondary|Percentage of Participants Achieving Seroconversion Against Antigens of B Strains After Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine|Seroconversion was defined as either a HAI titer <10 (1/dilution) at Day 0 and post-injection titer >=40 (1/dilution) at Day 28, or HAI titer >=10 (1/dilution) at Day 0 and a >=4-fold increase in HAI titer (1/dilution) at Day 28.|Day 28 post-vaccination|Analysis was performed on FAS. Here, ‘number analyzed’ = participants with available data for each category.|||percentage of participants||95% Confidence Interval|Number
2532967|NCT03282240|Secondary|GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine|GMTs of anti-influenza antibodies using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Geometric Mean Titers Ratios (GMTRs) were calculated as the ratio of GMTs post vaccination and pre-vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Analysis was performed on PPAS. Here, ‘number analyzed’ = participants with available data for each category.|||ratio||95% Confidence Interval|Number
2537970|NCT03118739|Other Pre-specified|Baseline MRI Variables - Diastolic Circumferential Strain Rate||Baseline|Total number differs from Study totals due to subject non compliance with MRI (exam not completed)|||s^-1||Standard Deviation|Mean
2532968|NCT03282240|Secondary|GMTs of B Strains Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine|Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). For each B strain, the immunogenicity of QIV-HD was compared to that of TIV-HD group which contains the corresponding B strain. TIV-HD1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.|Day 28 post-vaccination|Analysis was performed on full analysis set (FAS) that consisted who received at least 1 dose of a trial vaccine and had a post-vaccination blood sample HAI result for at least 1 strain. Participants were analyzed according to the vaccine group to which they were randomized.|||titers (1/dilution)||95% Confidence Interval|Geometric Mean
2532969|NCT03282240|Primary|Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine|Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Seroconversion was defined as either a HAI titer less than (<) 10 (1/dilution) at Day 0 and post-injection titer greater than or equal to (>=) 40 (1/dilution) at Day 28, or HAI titer >=10 (1/dilution) at Day 0 and a >=4-fold increase in HAI titer (1/dilution) at Day 28. For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.|Day 28 post-vaccination|Analysis was performed on PPAS. Here, ‘number analyzed’ = participants with available data for each category.|||percentage of participants||95% Confidence Interval|Number
2532970|NCT03282240|Primary|Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine|GMTs of anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.|Day 28 post-vaccination|Per-protocol analysis set (PPAS): all randomized participants who received at least 1 dose of trial vaccine & had a post-vaccination blood sample HAI result for at least 1 strain, with no relevant protocol deviations. Here, ‘number analyzed’ = participants with available data for each category.|||titers (1/dilution)||95% Confidence Interval|Geometric Mean
2532971|NCT03281668|Secondary|Change in Knee Strength|Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors extensors|Baseline, 12 weeks||||change in maximum kilograms||95% Confidence Interval|Mean
2532972|NCT03281668|Secondary|Change in Visceral Fat|visceral fat in kilograms, measured with DXA|Baseline, 12 weeks||||kilogram (kg)||95% Confidence Interval|Mean
2532973|NCT03281668|Secondary|Change in Lean Body Mass|lean body mass in kilograms, measured with DXA|Baseline, 12 weeks||||kilogram (kg)||95% Confidence Interval|Mean
2532974|NCT03281668|Secondary|Change in Whole Body Fat Mass|fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA)|Baseline, 12 weeks||||kilogram (kg)||95% Confidence Interval|Mean
2532975|NCT03281668|Secondary|Change in Cardiorespiratory Fitness|Measure by peak oxygen consumption (VO2peak),to identify fitness level and evaluate cardiovascular effects. Test will establish individual training intensity.|Baseline, 12 weeks||||change in liters/minute||95% Confidence Interval|Mean
2532976|NCT03281668|Secondary|Change in One Leg Stand|One leg stand for up to 30 seconds|Baseline, 12 weeks||||change in seconds||95% Confidence Interval|Mean
2532977|NCT03281668|Secondary|Change in Tandem Stand|One foot in front of the other, heel touching toe, for up to 10 seconds|Baseline, 12 weeks||||change in seconds||95% Confidence Interval|Mean
2532978|NCT03281668|Secondary|Change in Semi-tandem Stand|Heel of one foot placed to the side of the big toe of the other foot, for up to 10 seconds|Baseline, 12 weeks||||change in seconds||95% Confidence Interval|Mean
2532979|NCT03281668|Secondary|Change in Feet Together Stand|Feet together stand for up to 10 seconds without assistive device|Baseline, 12 weeks|All participants were able to complete Feet Together Stand at baseline and 12 weeks (no change).|||change in seconds||95% Confidence Interval|Mean
2532980|NCT03281668|Secondary|Change in Timed Up and Go|Time in seconds to rise from a chair, walk 3 m, turn, walk back to chair, and sit down|Baseline, 12 weeks||||change in seconds||95% Confidence Interval|Mean
2532981|NCT03281668|Secondary|Change in Stair Climb Test|Time in seconds to ascend and descend a flight of stairs|Baseline, 12 weeks||||change in seconds||95% Confidence Interval|Mean
2532982|NCT03281668|Secondary|Change in Number of Chair Stand Repetitions Completed|Number of chair stand repetitions completed in 30 seconds|Baseline, 12 weeks||||number of chair stands||95% Confidence Interval|Mean
2532983|NCT03281668|Secondary|Change in 20m Fast Paced Walk Test|Measure of the ability to walk quickly over short distances. Participants walk at fast pace that is timed over 2 x 10m.|Baseline, 12 weeks|Originally planned to have participants perform 40-meter walk; however, due to lab space constraints, this was altered to a 20-meter walk instead.|||seconds||95% Confidence Interval|Mean
2532984|NCT03281668|Secondary|Change in WOMAC Function Subscale From Baseline to 12 Weeks|The WOMAC function subscale contains 17 items about knee function during daily activities. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no problems with function) to 68 (extreme problems with function). A higher score means worse function.|Baseline, 12 weeks||||percentage change in score||95% Confidence Interval|Mean
2532985|NCT03281668|Secondary|Change in WOMAC Pain Subscale From Baseline to 12 Weeks|The WOMAC pain subscale contains 5 items about knee pain. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no pain) to 20 (extreme pain). A higher score means more severe pain.|Baseline,12 weeks||||percentage change in score||95% Confidence Interval|Mean
2533005|NCT03281200|Secondary|The Clinical Baseline Characteristics - Percentage of Patients With Usual Interstitial Pneumonia (UIP) Histopathological Pattern|The usual interstitial pneumonia (UIP) histopathological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.|From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.|All enrolled patients who met the selection criteria.|||Percentages of Patients|||Number
2532986|NCT03281668|Secondary|Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks|The WOMAC, a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), will be used to measure overall symptomatic burden of knee osteoarthritis (OA). Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a total WOMAC score ranging from 0 (no problems) to 96 (extreme problems). A higher score means a worse outcome.|Baseline,12 weeks||||percentage change in score||95% Confidence Interval|Mean
2532987|NCT03281668|Secondary|Total Number of Training Weeks Completed|Total number of training weeks (up to 12 weeks possible)|12 weeks||||weeks||Standard Deviation|Mean
2532988|NCT03281668|Secondary|Total Number of Training Sessions Completed|Total number of training sessions completed out of up to 24 sessions (2 per week over 12 weeks)|12 weeks||||training sessions||Standard Deviation|Mean
2532989|NCT03281668|Secondary|Average Number of Training Sessions Completed Per Week|Up to 2 training sessions were possible each week over the 12 week intervention|Weekly measures for 12 consecutive weeks||||training sessions per week||Standard Deviation|Mean
2532990|NCT03281668|Primary|Percentage of Enrolled Participants Retained at the End of the Study|Number of participants who completed the study (baseline through 12 week assessments) divided by the total number of enrolled participants with baseline assessments|Study completion (12 weeks)||||percentage of participants|||Number
2532991|NCT03281668|Primary|Percent of Potential Participants Screened for the Study Who Are Enrolled|Number of participants screened and enrolled divided by the total number of participants screened|Baseline||||percentage of participants|||Number
2532992|NCT03281200|Secondary|Percentage of Patients Distributed Across Different Lung Function Categories Based on the Reimbursement Threshold (%FVC)|The distribution of patients across different lung function categories based on the reimbursement threshold (FVC >80%, 50-80%, and <50%).|From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.|All enrolled patients who met the selection criteria.|||Percentages of Patients|||Number
2532993|NCT03281200|Secondary|Percentage of Patients With Other Concomitant Diseases at the Time of Treatment Initiation.|The percentage of patients with other concomitant diseases at the start of treatment with nintedanib (OFEV®) is presented.|From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.|All enrolled patients who met the selection criteria.|||Percentages of Patients|||Number
2532994|NCT03281200|Secondary|Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation.|The percentage of patients with comorbidity (concomitant diseases) at the start of treatment with nintedanib (OFEV®) is presented.|From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.|All enrolled patients who met the selection criteria.|||Percentages of Patients|||Number
2532995|NCT03281200|Secondary|The Clinical Baseline Characteristics - Percentage of Patients With Concomitant Treatments|The percentage of patients taking any concomitant medication at the start of nintedanib therapy is presented.|From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.|All enrolled patients who met the selection criteria.|||Percentages of Patients|||Number
2532996|NCT03281200|Secondary|The Clinical Baseline Characteristics - Percentage of Patients With Exacerbations|The percentage of patients with exacerbations of IPF in the year prior to initiating treatment is presented.|From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.|All enrolled patients who met the selection criteria.|||Percentages of patients|||Number
2532997|NCT03281200|Secondary|The Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea|The percentage of patients with dyspnoea at the start of treatment with nintedanib (OFEV®) is presented.|From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.|All enrolled patients who met the selection criteria.|||Percentages of Partients|||Number
2532998|NCT03281200|Secondary|The Demographic Baseline Characteristics - Percentage of Patients With Smoking Habit|The percentage of patients with smoking habit at the start of treatment with nintedanib (OFEV®) is presented.|From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.|All enrolled patients who met the selection criteria.|||Percentage of Participants|||Number
2532999|NCT03281200|Secondary|The Demographic Baseline Characteristics - 6-minute Walk Test|The 6-minute walk test of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.|From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.|All enrolled patients who met the selection criteria.|||Meter (m)||Standard Deviation|Mean
2533000|NCT03281200|Secondary|The Demographic Baseline Characteristics - Body Mass Index (BMI) at the Start of Nintedanib Therapy|The body mass index (BMI) of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.|From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.|All enrolled patients who met the selection criteria.|||Kilogram/ meter^2 (kg/m^2)||Standard Deviation|Mean
2533001|NCT03281200|Secondary|The Demographic Baseline Characteristics - Height at the Start of Nintedanib Therapy|The height of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.|From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.|All enrolled patients who met the selection criteria.|||Centimeters (cm)||Standard Deviation|Mean
2533002|NCT03281200|Secondary|The Demographic Baseline Characteristics - Weight at the Start of Nintedanib Therapy|The weight of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.|From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.|All enrolled patients who met the selection criteria.|||Kilogram (Kg)||Standard Deviation|Mean
2533003|NCT03281200|Secondary|The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV®|The percentage of patients initiated OFEV® dose of 150 milligram (mg)/ 12 hours (h) and 100 mg/12 h is presented.|From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.|All enrolled patients who met the selection criteria.|||Percentages of Patients|||Number
2564518|NCT02608099|Other Pre-specified|Number of Patients With Death|Death is included in this measurement.|Enrollment to 1 month post catheter ablation||||Participants|||Count of Participants
2533007|NCT03281200|Secondary|The Clinical Baseline Characteristics - Duration of the Disease|Duration of the disease of IPF patients, calculated as the time elapsed from the date of diagnosis until the start date of treatment with OFEV® (years).|From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.|All enrolled patients who met the selection criteria.|||Years||Standard Deviation|Mean
2533008|NCT03281200|Secondary|The Demographic Baseline Characteristics - Age at the Time of Treatment Initiation|The age of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.|From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.|All enrolled patients who met the selection criteria.|||Years||Standard Deviation|Mean
2533009|NCT03281200|Primary|Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide))|The distribution of patients across different lung function categories (% DLCO serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.|From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.|All enrolled patients who met the selection criteria.Include only those patients DLCO value who has been answered in the case report form (CRF).|||Percentage of Patients (%)|||Number
2533010|NCT03281200|Primary|Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity))|The distribution of patients across different lung function categories (% FVC serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.|From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.|All enrolled patients who met the selection criteria.|||Percentage of Patients (%)|||Number
2533011|NCT03280615|Secondary|Change in Pulse Wave Velocity at 12 Weeks of Intervention|Measurement of pulse wave velocity using a oscillometric device measured at baseline and end of follow up and expressed ad m/s|At baseline and 12 weeks of intervention||||m/s||Inter-Quartile Range|Median
2533012|NCT03280615|Secondary|Change in C Reactive Protein Levels at 12 Weeks of Intervention|Blood C reactive protein measured at baseline and the end of the intervention.|At baseline and 12 weeks of intervention||||mg/L||Inter-Quartile Range|Median
2533013|NCT03280615|Primary|Number of Participants With a Urine Albumin Excretion Decrease of 20% or More|Number of participants in whom urine albumin excretion in a spot urine sample at the end of follow up, expressed as mg/g creatinine, decreased by 20% or more|At baseline and 12 weeks of intervention||||Participants|||Count of Participants
2533014|NCT03280550|Secondary|Median Serum Concentration of Total and Free Immunoglobulin E (IgE) at Specified Timepoints|Serum concentrations of total immunoglobulin E (IgE) and free IgE were measured throughout the 24-week blinded treatment period, as target engagement biomarkers of omalizumab, using validated quantitative immunoassays with lower limits of quantification of 2 and 0.83 International Units per millilitre (IU/mL), respectively, and upper limits of quantification (ULQ) of 5000 and 62.5 IU/mL, respectively. The free IgE assay had limited range to measure circulating levels of free IgE in the presence of complexes of omalizumab-IgE. According to the analysis plan for the free IgE assay, results above ULQ were set to 62.5 IU/mL. If results for one-third or fewer of the participants were greater than the ULQ, then all summary statistics were to be reported. However, if the results for more than one-third of participants were greater than the ULQ, then only the median, interquartile range and minimum were calculated, and the mean, standard deviation, and maximum were non-reportable.|Predose on Day 1, Week 16, Week 24|Pharmacokinetics Evaluable Analysis Set: includes participants who received study drug per protocol. The number analyzed includes participants with evaluable samples at each timepoint.|||IU/mL||Inter-Quartile Range|Median
2533015|NCT03280550|Secondary|Mean Serum Concentration of Total and Free Immunoglobulin E (IgE) at Specified Timepoints|Serum concentrations of total immunoglobulin E (IgE) and free IgE were measured throughout the 24-week blinded treatment period, as target engagement biomarkers of omalizumab, using validated quantitative immunoassays with lower limits of quantification of 2 and 0.83 International Units per millilitre (IU/mL), respectively, and upper limits of quantification (ULQ) of 5000 and 62.5 IU/mL, respectively. The free IgE assay had limited range to measure circulating levels of free IgE in the presence of complexes of omalizumab-IgE. According to the analysis plan for the free IgE assay, results above ULQ were set to 62.5 IU/mL. If results for one-third or fewer of the participants were greater than the ULQ, then all summary statistics were to be reported. However, if the results for more than one-third of participants were greater than the ULQ, then only the median, interquartile range and minimum were calculated, and the mean, standard deviation, and maximum were non-reportable.|Predose on Day 1, Week 16, Week 24|Pharmacokinetics Evaluable Analysis Set: includes participants who received study drug per protocol. The number analyzed includes participants with evaluable samples at each timepoint.|||IU/mL||Standard Deviation|Mean
2533016|NCT03280550|Secondary|Median Serum Concentration of Omalizumab at Specified Timepoints|Serum concentrations of omalizumab were quantified using an enzyme-linked immunoabsorbent assay (ELISA) with a lower limit of quantification (LLOQ) of 28.0 nanograms per millilitre (ng/mL). According to the analysis plan, values below the lower limit of quantification (BLQ) were set to 14 ng/mL (i.e. half of LLOQ value). If one-third or fewer of participants had results that were BLQ, then all summary statistics were to be calculated. However, if more than one-third of participants had results that were BLQ, then the mean and standard deviation were non-reportable and only the median and maximum were to be calculated for that timepoint.|Predose on Day 1, Week 16, Week 24, Unscheduled Visit (outside of planned study visits, as clinically indicated), Dosing Termination/Early Termination Visit (up to 28 weeks)|Pharmacokinetics Evaluable Analysis Set: includes participants who received study drug per protocol. Only the omalizumab-treated participants with evaluable samples at each timepoint were included in this analysis.|||nanograms per millilitre (ng/mL)||Full Range|Median
2533064|NCT03280108|Secondary|"Proportion of Subjects Who Respond Never to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire"|"The IOLSAT is a patient-reported outcomes questionnaire. Subjects were asked, Overall, in the past 7 days, how often did you need to wear eyeglasses to see? The proportion of subjects who respond Never is reported as a percentage calculated as (# of subjects responding Never) divided by (# of subjects with bilateral implantation and concordant, non-missing data) times 100."|Month 6 (Day 120-180), post second eye implantation|This analysis population includes all subjects with bilateral implantation and concordant, non-missing data.|||percentage of subjects|||Number
2533017|NCT03280550|Secondary|Mean Serum Concentration of Omalizumab at Specified Timepoints|Serum concentrations of omalizumab were quantified using an enzyme-linked immunoabsorbent assay (ELISA) with a lower limit of quantification (LLOQ) of 28.0 nanograms per millilitre (ng/mL). According to the analysis plan, values below the lower limit of quantification (BLQ) were set to 14 ng/mL (i.e. half of LLOQ value). If one-third or fewer of participants had results that were BLQ, then all summary statistics were to be calculated. However, if more than one-third of participants had results that were BLQ, then the mean and standard deviation were non-reportable and only the median and maximum were to be calculated for that timepoint.|Predose on Day 1, Week 16, Week 24, Unscheduled Visit (outside of planned study visits, as clinically indicated), Dosing Termination/Early Termination Visit (up to 28 weeks)|Pharmacokinetics Evaluable Analysis Set: includes participants who received study drug per protocol. Only the omalizumab-treated participants with evaluable samples at each timepoint were included in this analysis.|||nanograms per millilitre (ng/mL)||Standard Deviation|Mean
2533018|NCT03280550|Secondary|Number of Participants With Laboratory Abnormalities by Highest Grade Post-Baseline|Clinical laboratory tests for serum chemistry and hematology parameters were performed at laboratories; any abnormal values (High or Low) were based on laboratory normal ranges. Laboratory abnormalities are presented by the highest grade according to the World Health Organization (WHO) grade for Adverse Events, except for eosinophils and white blood cells that were graded according to the FDA Toxicity Grading Scale for Healthy Volunteers. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. SGPT/ALT = serum glutamic-pyruvic transaminase/alanine aminotransferase; SGOT/AST = serum glutamic-oxaloacetic transaminase/aspartate aminotransferase|Up to Week 28|Safety Analysis Set: all participants who received at least one dose of study drug, grouped according to treatment received during the treatment period.|||Participants|||Count of Participants
2533019|NCT03280550|Secondary|Number of Participants With Adverse Events Leading to Omalizumab/Placebo Discontinuation||Up to Week 24|Safety Analysis Set: all participants who received at least one dose of study drug, grouped according to treatment received during the treatment period.|||Participants|||Count of Participants
2533020|NCT03280550|Secondary|Number of Participants Who Experienced at Least One Serious Adverse Event|A serious adverse event was defined as any adverse event that met any of the following criteria: was fatal; was life-threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study drug; or, was a significant medical event in the investigator's judgment. Multiple occurrences of the same serious adverse event in one individual were counted once.|Up to Week 28|Safety Analysis Set: all participants who received at least one dose of study drug, grouped according to treatment received during the treatment period.|||Participants|||Count of Participants
2533021|NCT03280550|Secondary|Number of Participants Who Experienced at Least One Adverse Event by Greatest Severity|"All adverse events (AE) were treatment emergent AEs, defined as any new AE or any worsening of an existing condition with an onset date on or after the first study drug administration date. AEs were assessed for severity according to the following grading scale: mild (discomfort noticed, but no disruption of normal daily activity), moderate (discomfort sufficient to reduce or affect normal daily activity), or severe (incapacitating with inability to work or to perform normal daily activity). The terms severe and serious are not synonymous; regardless of severity, some events may have also met seriousness criteria. Multiple occurrences of the same AE in one individual are counted once at the greatest intensity."|Up to Week 28|Safety Analysis Set: all participants who received at least one dose of study drug, grouped according to treatment received during the treatment period.|||Participants|||Count of Participants
2533022|NCT03280550|Secondary|Change From Baseline in Sense of Smell, as Assessed by The University of Pennsylvania Smell Identification Test (UPSIT) at Week 24|"The UPSIT is a 40-question instrument that measures an individual's ability to detect odors and ranges from 0 to 40, with a higher score indicating a better sense of smell. It is a self-administered scratch-and-sniff test provided in booklets that have 40 microencapsulated odorants, each with a multiple-choice option for the response. The number of correct responses is summed to provide a total score."|Baseline, Week 24|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533023|NCT03280550|Secondary|Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) at Week 24|The Total Nasal Symptom Score (TNSS) was defined as the sum of the four individual scores for Nasal Congestion Score, Anterior Rhinorrhea Score, Posterior Rhinorrhea Score, and Sense of Smell Score, ranging from 0 (no symptoms) to 12 (most severe symptoms), assessed daily by the participant via an electronic diary. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.|Baseline, Week 24 (Study Days 155 to 186)|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533030|NCT03280550|Secondary|Change From Baseline in Participant Reported Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Questionnaire at Week 24|The SNOT-22 Questionnaire, a disease specific HRQoL measure, comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant was asked to rate how severe each problem had been for them over the past 2 weeks on a scale from 0 (no problem at all) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating less disease and better HRQoL. A negative score indicates a decrease (or improvement) from the baseline score.|Baseline, Week 24|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533024|NCT03280550|Secondary|Number of Participants With Reduction in the Need for Surgery for Nasal Polyps by Week 24, as Defined by an NPS of ≤4 (Unilateral Score of ≤2 on Each Side) and Improvement in SNOT-22 Score of ≥8.9|A participant was considered to have had the event of reduction in the need for surgery for nasal polyps if they had a Nasal Polyp Score (NPS) of ≤4 and an improvement in the SNOT-22 score of ≥8.9 (minimal important difference) without rescue treatment at Week 24; if the participant had received rescue treatment or had discontinued study drug due to adverse event, progressive disease, or lack of efficacy and remained missing, then they did not have the event. Participants without an intercurrent event and without valid Week 24 assessments of both NPS and SNOT-22 were classified as having a missing outcome. The null hypothesis was to be assessed by the Wald Chi-square test of the treatment term in the logistic regression model. If model convergence was an issue, then Fisher's Exact test was to be used.|Up to Week 24|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis.|||Participants|||Count of Participants
2533025|NCT03280550|Secondary|Number of Participants Requiring Rescue Treatment (Systemic Corticosteroids For ≥3 Consecutive Days or Having Had Surgery for Nasal Polyps) Through Week 24|A participant was considered to have had the event of requiring rescue treatment if they had taken systemic corticosteroids for 3 or more consecutive days or had nasal polypectomy at any point between randomization and Week 24; if the participant had greater than 155 days of follow-up on study and had not received rescue treatment, then they did not have the event. Participants with less than 155 days of follow-up on the study were classified as having had the event if they discontinued study drug due to adverse event, progressive disease, or lack of efficacy and remained missing; if the participant had less than 155 days of follow-up on study and had not already met these criteria, they were classified as having a missing outcome. The null hypothesis was to be assessed by the Wald Chi-square test of the treatment term in the logistic regression model. If model convergence was an issue, then Fisher's Exact test was to be used.|Up to Week 24|Full Analysis Set: all participants randomized to study treatment. Only participants on study through Week 24 were included in the analysis.|||Participants|||Count of Participants
2533026|NCT03280550|Secondary|Number of Participants With a Change From Baseline at Week 24 in Asthma Quality of Life Questionnaire (AQLQ) of ≥0.5 in Participants With Comorbid Asthma Only|The AQLQ is a 32-item participant-reported measure of asthma-related quality of life (QoL) with a total score (the mean of all 32 responses) ranging from 1 (severely impaired) to 7 (not impaired at all); a higher score indicates a better QoL. An increase of at least 0.5 points in the AQLQ score was considered the minimal important difference for improvement in QoL.|Baseline, Week 24|Analysis was conducted only in the subgroup of participants with comorbid asthma at screening and AQLQ assessments at Baseline and Week 24.|||Participants|||Count of Participants
2533027|NCT03280550|Secondary|Number of Participants Having Had Surgery for Nasal Polyps Through Week 24|A participant was considered to have had the event of surgery for nasal polyps if they underwent the procedure at any point between randomization and Week 24; if the participant had greater than 155 days of follow-up on study and had not undergone surgery for nasal polyps, then they did not have the event. Participants with less than 155 days of follow-up on the study were classified as having had the event if they discontinued study drug due to adverse event, progressive disease, or lack of efficacy and remained missing; if the participant had less than 155 days of follow-up on study and had not already met these criteria, they were classified as having a missing outcome. The null hypothesis was to be assessed by the Wald Chi-square test of the treatment term in the logistic regression model. If model convergence was an issue, then Fisher's Exact test was to be used.|Up to Week 24|Full Analysis Set: all participants randomized to study treatment. Only participants on study through Week 24 were included in the analysis.|||Participants|||Count of Participants
2533028|NCT03280550|Secondary|Number of Participants Requiring Rescue Medication (Systemic Corticosteroids for ≥3 Consecutive Days) Through Week 24|A participant was considered to have had the event of requiring rescue medication if they had taken systemic corticosteroids for 3 or more consecutive days at any point between randomization and Week 24; if the participant had greater than 155 days of follow-up on study and had not taken systemic corticosteroids for 3 or more consecutive days, then they did not have the event. Participants with less than 155 days of follow-up on the study were classified as having had the event if they discontinued study drug due to adverse event, progressive disease, or lack of efficacy and remained missing; if the participant had less than 155 days of follow-up on study and had not already met these criteria, they were classified as having a missing outcome. The null hypothesis was to be assessed by the Wald Chi-square test of the treatment term in the logistic regression model. If model convergence was an issue, then Fisher's Exact test was to be used.|Up to Week 24|Full Analysis Set: all participants randomized to study treatment. Only participants on study through Week 24 were included in the analysis.|||Participants|||Count of Participants
2533029|NCT03280550|Secondary|Change From Baseline in Average Daily Anterior Rhinorrhea Score at Week 24|The Anterior Rhinorrhea Score was assessed daily by the participant via an electronic diary as the response to the following question: Do you have a runny nose? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0=Not at all; 1=Mild; 2=Moderate; and 3=Severe. For each study day, a score was calculated using an average of the prior 7 days among available days within a pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days, otherwise the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.|Baseline, Week 24 (Study Days 155 to 186)|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533042|NCT03280537|Secondary|Number of Participants With Adverse Events Leading to Omalizumab/Placebo Discontinuation||Up to Week 24|Safety Analysis Set: all participants who received at least one dose of study drug, grouped according to treatment received during the treatment period. One participant in the Placebo arm received incorrectly one dose of omalizumab and was included in the Omalizumab arm for safety analyses.|||Participants|||Count of Participants
2533031|NCT03280550|Secondary|Change From Baseline in Average Daily Nasal Congestion Score (NCS) at Week 16|The Nasal Congestion Score (NCS) was assessed daily by the participant via an electronic diary as the response to the following question: Is your nose blocked? The four available response options, scored from 0 (no symptoms) to 3 (severe symptoms) were: 0 = Not at all; 1 = Mild; 2 = Moderate; and 3 = Severe. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 16: Study Days 99 to 126), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 112), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.|Baseline, Week 16 (Study Days 99 to 126)|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 16 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533032|NCT03280550|Secondary|Change From Baseline in Nasal Polyp Score (NPS) at Week 16|Total NPS ranges from 0 to 8 (sum of 0-4 for left and right nasal passage scores per the following criteria), with a lower score indicating smaller-sized nasal polyps: 0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate; 2 = Polyps reaching below the lower border of the middle turbinate (modified to accommodate those with a middle turbinectomy, such that polyp must have reached the top of the inferior turbinate.); 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate; and 4 = Large polyps causing complete obstruction of the inferior nasal cavity. Two blinded primary independent expert readers reviewed every post-screening recorded video endoscopy for a given participant to determine total NPS. A third reader chose one of the two scores to be used for analysis in cases where there was any discrepancy in total NPS assigned between the two primary readers.|Baseline, Week 16|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 16 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533033|NCT03280550|Secondary|Change From Baseline in Average Daily Posterior Rhinorrhea Score at Week 24|The Posterior Rhinorrhea Score was assessed daily by the participant via an electronic diary as the response to the following question: Do you feel dripping at the back of the nose? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0=Not at all; 1=Mild; 2=Moderate; and 3=Severe. For each study day, a score was calculated using an average of the prior 7 days among available days within a pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days, otherwise the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.|Baseline, Week 24 (Study Days 155 to 186)|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533034|NCT03280550|Secondary|Change From Baseline in Average Daily Sense of Smell Score at Week 24|The Sense of Smell Score was assessed daily by the participant via an electronic diary as the response to the following question: Is your sense of smell reduced? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0 = Not at all; 1 = Mild; 2 = Moderate; and 3 = Severe. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.|Baseline, Week 24 (Study Days 155 to 186)|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533035|NCT03280550|Primary|Change From Baseline in Average Daily Nasal Congestion Score (NCS) at Week 24|The Nasal Congestion Score (NCS) was assessed daily by the participant via an electronic diary as the response to the following question: Is your nose blocked? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0 = Not at all; 1 = Mild; 2 = Moderate; and 3 = Severe. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.|Baseline, Week 24 (Study Days 155 to 186)|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533043|NCT03280537|Secondary|Number of Participants Who Experienced at Least One Serious Adverse Event|A serious adverse event was defined as any adverse event that met any of the following criteria: was fatal; was life-threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the study drug; or, was a significant medical event in the investigator's judgment. Multiple occurrences of the same serious adverse event in one individual were counted once.|Up to Week 28|Safety Analysis Set: all participants who received at least one dose of study drug, grouped according to treatment received during the treatment period. One participant in the Placebo arm received incorrectly one dose of omalizumab and was included in the Omalizumab arm for safety analyses.|||Participants|||Count of Participants
2533036|NCT03280550|Primary|Change From Baseline in Nasal Polyp Score (NPS) at Week 24|Total NPS ranges from 0 to 8 (sum of 0-4 for left and right nasal passage scores per the following criteria), with a lower score indicating smaller-sized nasal polyps: 0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate; 2 = Polyps reaching below the lower border of the middle turbinate (modified to accommodate those with a middle turbinectomy, such that polyp must have reached the top of the inferior turbinate.); 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate; and 4 = Large polyps causing complete obstruction of the inferior nasal cavity. Two blinded primary independent expert readers reviewed every post-screening recorded video endoscopy for a given participant to determine total NPS. A third reader chose one of the two scores to be used for analysis in cases where there was any discrepancy in total NPS assigned between the two primary readers.|Baseline, Week 24|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533037|NCT03280537|Secondary|Median Serum Concentration of Total and Free Immunoglobulin E (IgE) at Specified Timepoints|Serum concentrations of total immunoglobulin E (IgE) and free IgE were measured throughout the 24-week blinded treatment period, as target engagement biomarkers of omalizumab, using validated quantitative immunoassays with lower limits of quantification of 2 and 0.83 International Units per millilitre (IU/mL), respectively, and upper limits of quantification (ULQ) of 5000 and 62.5 IU/mL, respectively. The free IgE assay had limited range to measure circulating levels of free IgE in the presence of complexes of omalizumab-IgE. According to the analysis plan for the free IgE assay, results above ULQ were set to 62.5 IU/mL. If results for one-third or fewer of the participants were greater than the ULQ, then all summary statistics were to be reported. However, if the results for more than one-third of participants were greater than the ULQ, then only the median, interquartile range and minimum were calculated, and the mean, standard deviation, and maximum were non-reportable.|Predose on Day 1, Week 16, Week 24|Pharmacokinetics Evaluable Analysis Set: includes participants who received study drug per protocol. The number analyzed includes participants with evaluable samples at each timepoint.|||IU/mL||Inter-Quartile Range|Median
2533038|NCT03280537|Secondary|Mean Serum Concentration of Total and Free Immunoglobulin E (IgE) at Specified Timepoints|Serum concentrations of total immunoglobulin E (IgE) and free IgE were measured throughout the 24-week blinded treatment period, as target engagement biomarkers of omalizumab, using validated quantitative immunoassays with lower limits of quantification of 2 and 0.83 International Units per millilitre (IU/mL), respectively, and upper limits of quantification (ULQ) of 5000 and 62.5 IU/mL, respectively. The free IgE assay had limited range to measure circulating levels of free IgE in the presence of complexes of omalizumab-IgE. According to the analysis plan for the free IgE assay, results above ULQ were set to 62.5 IU/mL. If results for one-third or fewer of the participants were greater than the ULQ, then all summary statistics were to be reported. However, if the results for more than one-third of participants were greater than the ULQ, then only the median, interquartile range and minimum were calculated, and the mean, standard deviation, and maximum were non-reportable.|Predose on Day 1, Week 16, Week 24|Pharmacokinetics Evaluable Analysis Set: includes participants who received study drug per protocol. The number analyzed includes participants with evaluable samples at each timepoint.|||IU/mL||Standard Deviation|Mean
2533039|NCT03280537|Secondary|Median Serum Concentration of Omalizumab at Specified Timepoints|Serum concentrations of omalizumab were quantified using an enzyme-linked immunoabsorbent assay (ELISA) with a lower limit of quantification (LLOQ) of 28.0 nanograms per millilitre (ng/mL). According to the analysis plan, values below the lower limit of quantification (BLQ) were set to 14 ng/mL (i.e. half of LLOQ value). If one-third or fewer of participants had results that were BLQ, then all summary statistics were to be calculated. However, if more than one-third of participants had results that were BLQ, then the mean and standard deviation were non-reportable and only the median and maximum were to be calculated for that timepoint.|Predose on Day 1, Week 16, Week 24, Unscheduled Visit (outside of planned study visits, as clinically indicated), Dosing Termination/Early Termination Visit (up to 28 weeks)|Pharmacokinetics Evaluable Analysis Set: includes participants who received study drug per protocol. Only the omalizumab-treated participants with evaluable samples at each timepoint were included in this analysis.|||nanograms per millilitre (ng/mL)||Full Range|Median
2533040|NCT03280537|Secondary|Mean Serum Concentration of Omalizumab at Specified Timepoints|Serum concentrations of omalizumab were quantified using an enzyme-linked immunoabsorbent assay (ELISA) with a lower limit of quantification (LLOQ) of 28.0 nanograms per millilitre (ng/mL). According to the analysis plan, values below the lower limit of quantification (BLQ) were set to 14 ng/mL (i.e. half of LLOQ value). If one-third or fewer of participants had results that were BLQ, then all summary statistics were to be calculated. However, if more than one-third of participants had results that were BLQ, then the mean and standard deviation were non-reportable and only the median and maximum were to be calculated for that timepoint.|Predose on Day 1, Week 16, Week 24, Unscheduled Visit (outside of planned study visits, as clinically indicated), Dosing Termination/Early Termination Visit (up to 28 weeks)|Pharmacokinetics Evaluable Analysis Set: includes participants who received study drug per protocol. Only the omalizumab-treated participants with evaluable samples at each timepoint were included in this analysis.|||nanograms per millilitre (ng/mL)||Standard Deviation|Mean
2533041|NCT03280537|Secondary|Number of Participants With Laboratory Abnormalities by Highest Grade Post-Baseline|Clinical laboratory tests for serum chemistry and hematology parameters were performed at laboratories; any abnormal values (High or Low) were based on laboratory normal ranges. Laboratory abnormalities are presented by the highest grade according to the World Health Organization (WHO) grade for Adverse Events, except for eosinophils and white blood cells that were graded according to the FDA Toxicity Grading Scale for Healthy Volunteers. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. SGPT/ALT = serum glutamic-pyruvic transaminase/alanine aminotransferase; SGOT/AST = serum glutamic-oxaloacetic transaminase/aspartate aminotransferase|Up to Week 28|Safety Analysis Set: all participants who received at least one dose of study drug, grouped according to treatment received during the treatment period. One participant in the Placebo arm received incorrectly one dose of omalizumab and was included in the Omalizumab arm for safety analyses.|||Participants|||Count of Participants
2533044|NCT03280537|Secondary|Number of Participants Who Experienced at Least One Adverse Event by Greatest Severity|"All adverse events (AE) were treatment emergent AEs, defined as any new AE or any worsening of an existing condition with an onset date on or after the first study drug administration date. AEs were assessed for severity according to the following grading scale: mild (discomfort noticed, but no disruption of normal daily activity), moderate (discomfort sufficient to reduce or affect normal daily activity), or severe (incapacitating with inability to work or to perform normal daily activity). The terms severe and serious are not synonymous; regardless of severity, some events may have also met seriousness criteria. Multiple occurrences of the same AE in one individual are counted once at the greatest intensity."|Up to Week 28|Safety Analysis Set: all participants who received at least one dose of study drug, grouped according to treatment received during the treatment period. One participant in the Placebo arm received incorrectly one dose of omalizumab and was included in the Omalizumab arm for safety analyses.|||Participants|||Count of Participants
2533045|NCT03280537|Secondary|Change From Baseline in Sense of Smell, as Assessed by The University of Pennsylvania Smell Identification Test (UPSIT) Score at Week 24|"The UPSIT is a 40-question instrument that measures an individual's ability to detect odors and ranges from 0 to 40, with a higher score indicating a better sense of smell. It is a self-administered scratch-and-sniff test provided in booklets that have 40 microencapsulated odorants, each with a multiple-choice option for the response. The number of correct responses is summed to provide a total score."|Baseline, Week 24|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533046|NCT03280537|Secondary|Change From Baseline in Average Daily Total Nasal Symptom Score (TNSS) at Week 24|The Total Nasal Symptom Score (TNSS) was defined as the sum of the four individual scores for Nasal Congestion Score, Anterior Rhinorrhea Score, Posterior Rhinorrhea Score, and Sense of Smell Score, ranging from 0 (no symptoms) to 12 (most severe symptoms), assessed daily by the participant via an electronic diary. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.|Baseline, Week 24 (Study Days 155 to 186)|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533047|NCT03280537|Secondary|Number of Participants With Reduction in the Need for Surgery for Nasal Polyps by Week 24, as Defined by an NPS of ≤4 (Unilateral Score of ≤2 on Each Side) and Improvement in SNOT-22 Score of ≥8.9|A participant was considered to have had the event of reduction in the need for surgery for nasal polyps if they had a Nasal Polyp Score (NPS) of ≤4 and an improvement in the SNOT-22 score of ≥8.9 (minimal important difference) without rescue treatment at Week 24; if the participant had received rescue treatment or had discontinued study drug due to adverse event, progressive disease, or lack of efficacy and remained missing, then they did not have the event. Participants without an intercurrent event and without valid Week 24 assessments of both NPS and SNOT-22 were classified as having a missing outcome. The null hypothesis was to be assessed by the Wald Chi-square test of the treatment term in the logistic regression model. If model convergence was an issue, then Fisher's Exact test was to be used.|Up to Week 24|Full Analysis Set: all participants randomized to study treatment. Only participants on study through Week 24 were included in the analysis.|||Participants|||Count of Participants
2533048|NCT03280537|Secondary|Number of Participants Requiring Rescue Treatment (Systemic Corticosteroids For ≥3 Consecutive Days or Having Had Surgery for Nasal Polyps) Through Week 24|A participant was considered to have had the event of requiring rescue treatment if they had taken systemic corticosteroids for 3 or more consecutive days or had nasal polypectomy at any point between randomization and Week 24; if the participant had greater than 155 days of follow-up on study and had not received rescue treatment, then they did not have the event. Participants with less than 155 days of follow-up on the study were classified as having had the event if they discontinued study drug due to adverse event, progressive disease, or lack of efficacy and remained missing; if the participant had less than 155 days of follow-up on study and had not already met these criteria, they were classified as having a missing outcome. The null hypothesis was to be assessed by the Wald Chi-square test of the treatment term in the logistic regression model. If model convergence was an issue, then Fisher's Exact test was to be used.|Up to Week 24|Full Analysis Set: all participants randomized to study treatment. Only participants on study through Week 24 were included in the analysis.|||Participants|||Count of Participants
2533049|NCT03280537|Secondary|Number of Participants With a Change From Baseline at Week 24 in Asthma Quality of Life Questionnaire (AQLQ) of ≥0.5 in Participants With Comorbid Asthma Only|The AQLQ is a 32-item participant-reported measure of asthma-related quality of life (QoL) with a total score (the mean of all 32 responses) ranging from 1 (severely impaired) to 7 (not impaired at all); a higher score indicates a better QoL. An increase of at least 0.5 points in the AQLQ score was considered the minimal important difference for improvement in QoL.|Baseline and Week 24|Analysis was conducted only in the subgroup of participants with comorbid asthma at screening and AQLQ assessments at Baseline and Week 24.|||Participants|||Count of Participants
2533063|NCT03280108|Secondary|Rate of Severe Visual Disturbances as Reported by the Subject Using the Questionnaire for Visual Disturbances (QUVID)|"QUVID is a patient-reported outcomes questionnaire that collects responses about visual disturbance. Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer about how severe their worst experience was on a scale from 0-4, where 0=none and 4=severe. The percentage of subjects responding Severe was calculated as (# of subjects responding Severe) divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure."|Month 6 (Day 120-180), post second eye implantation|This analysis population includes all subjects with bilateral implantation and non-missing data.|||Participants|||Count of Participants
2533050|NCT03280537|Secondary|Number of Participants Having Had Surgery for Nasal Polyps Through Week 24|A participant was considered to have had the event of surgery for nasal polyps if they underwent the procedure at any point between randomization and Week 24; if the participant had greater than 155 days of follow-up on study and had not undergone surgery for nasal polyps, then they did not have the event. Participants with less than 155 days of follow-up on the study were classified as having had the event if they discontinued study drug due to adverse event, progressive disease, or lack of efficacy and remained missing; if the participant had less than 155 days of follow-up on study and had not already met these criteria, they were classified as having a missing outcome. The null hypothesis was to be assessed by the Wald Chi-square test of the treatment term in the logistic regression model. If model convergence was an issue, then Fisher's Exact test was to be used.|Up to Week 24|Full Analysis Set: all participants randomized to study treatment. Only participants on study through Week 24 were included in the analysis.|||Participants|||Count of Participants
2533051|NCT03280537|Secondary|Number of Participants Requiring Rescue Medication (Systemic Corticosteroids for ≥3 Consecutive Days) Through Week 24|A participant was considered to have had the event of requiring rescue medication if they had taken systemic corticosteroids for 3 or more consecutive days at any point between randomization and Week 24; if the participant had greater than 155 days of follow-up on study and had not taken systemic corticosteroids for 3 or more consecutive days, then they did not have the event. Participants with less than 155 days of follow-up on the study were classified as having had the event if they discontinued study drug due to adverse event, progressive disease, or lack of efficacy and remained missing; if the participant had less than 155 days of follow-up on study and had not already met these criteria, they were classified as having a missing outcome. The null hypothesis was to be assessed by the Wald Chi-square test of the treatment term in the logistic regression model. If model convergence was an issue, then Fisher's Exact test was to be used.|Up to Week 24|Full Analysis Set: all participants randomized to study treatment. Only participants on study through Week 24 were included in the analysis.|||Participants|||Count of Participants
2533052|NCT03280537|Secondary|Change From Baseline in Average Daily Anterior Rhinorrhea Score at Week 24|The Anterior Rhinorrhea Score was assessed daily by the participant via an electronic diary as the response to the following question: Do you have a runny nose? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0=Not at all; 1=Mild; 2=Moderate; and 3=Severe. For each study day, a score was calculated using an average of the prior 7 days among available days within a pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days, otherwise the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.|Baseline, Week 24 (Study Days 155 to 186)|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533053|NCT03280537|Secondary|Change From Baseline in Participant Reported Health-Related Quality of Life (HRQoL) as Assessed by the Total Sino-Nasal Outcome Test (SNOT)-22 Questionnaire at Week 24|The SNOT-22 Questionnaire, a disease specific HRQoL measure, comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant was asked to rate how severe each problem had been for them over the past 2 weeks on a scale from 0 (no problem at all) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating less disease and better HRQoL. A negative score indicates a decrease (or improvement) from the baseline score.|Baseline, Week 24|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533054|NCT03280537|Secondary|Change From Baseline in Average Daily Nasal Congestion Score at Week 16|The Nasal Congestion Score (NCS) was assessed daily by the participant via an electronic diary as the response to the following question: Is your nose blocked? The four available response options, scored from 0 (no symptoms) to 3 (severe symptoms) were: 0 = Not at all; 1 = Mild; 2 = Moderate; and 3 = Severe. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 16: Study Days 99 to 126), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 112), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.|Baseline, Week 16 (Study Days 99 to 126)|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 16 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533055|NCT03280537|Secondary|Change From Baseline in Nasal Polyp Score (NPS) at Week 16|Total NPS ranges from 0 to 8 (sum of 0-4 for left and right nasal passage scores per the following criteria), with a lower score indicating smaller-sized nasal polyps: 0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate; 2 = Polyps reaching below the lower border of the middle turbinate (modified to accommodate those with a middle turbinectomy, such that polyp must have reached the top of the inferior turbinate.); 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate; and 4 = Large polyps causing complete obstruction of the inferior nasal cavity. Two blinded primary independent expert readers reviewed every post-screening recorded video endoscopy for a given participant to determine total NPS. A third reader chose one of the two scores to be used for analysis in cases where there was any discrepancy in total NPS assigned between the two primary readers.|Baseline, Week 16|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 16 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533074|NCT03278106|Other Pre-specified|Mutation Status of the Tumor|Will determine if different mutations status of the tumor will affect efficacy endpoints.|Up to 3 years|||||||
2533056|NCT03280537|Secondary|Change From Baseline in Average Daily Posterior Rhinorrhea Score at Week 24|The Posterior Rhinorrhea Score was assessed daily by the participant via an electronic diary as the response to the following question: Do you feel dripping at the back of the nose? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0=Not at all; 1=Mild; 2=Moderate; and 3=Severe. For each study day, a score was calculated using an average of the prior 7 days among available days within a pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days, otherwise the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.|Baseline, Week 24 (Study Days 155 to 186)|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533057|NCT03280537|Secondary|Change From Baseline in Average Daily Sense of Smell Score at Week 24|The Sense of Smell Score was assessed daily by the participant via an electronic diary as the response to the following question: Is your sense of smell reduced? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0 = Not at all; 1 = Mild; 2 = Moderate; and 3 = Severe. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.|Baseline, Week 24 (Study Days 155 to 186)|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533058|NCT03280537|Primary|Change From Baseline in Average Daily Nasal Congestion Score (NCS) at Week 24|The Nasal Congestion Score (NCS) was assessed daily by the participant via an electronic diary as the response to the following question: Is your nose blocked? The four available response options were scored from 0 (no symptoms) to 3 (severe symptoms): 0 = Not at all; 1 = Mild; 2 = Moderate; and 3 = Severe. For each study day, a score was calculated using an average of the prior 7 days among the available days within the pre-specified window (For Week 24: Study Days 155 to 186), excluding the study day itself, if a value had been recorded by the participant on at least 4 of the prior 7 days; otherwise, the 7-day prior average for that study day was to be considered missing. One calculated (non-missing) 7-day prior average was selected for analysis according to the study day with nearest proximity to Week 24 (Study Day 168), with the earlier selected in the case of a tie. Baseline was defined as the (non-missing) 7-day interval ending on the latest day prior to randomization.|Baseline, Week 24 (Study Days 155 to 186)|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533059|NCT03280537|Primary|Change From Baseline in Nasal Polyp Score (NPS) at Week 24|Total NPS ranges from 0 to 8 (sum of 0-4 for left and right nasal passage scores per the following criteria), with a lower score indicating smaller-sized nasal polyps: 0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle turbinate; 2 = Polyps reaching below the lower border of the middle turbinate (modified to accommodate those with a middle turbinectomy, such that polyp must have reached the top of the inferior turbinate.); 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate; and 4 = Large polyps causing complete obstruction of the inferior nasal cavity. Two blinded primary independent expert readers reviewed every post-screening recorded video endoscopy for a given participant to determine total NPS. A third reader chose one of the two scores to be used for analysis in cases where there was any discrepancy in total NPS assigned between the two primary readers.|Baseline, Week 24|Full Analysis Set: all participants randomized to study treatment. Only participants with assessments at Baseline and Week 24 were included in the analysis.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2533060|NCT03280381|Primary|Spillage|Spillage will be reported as a percent with the amount of milk in grams spilled/mopped up divided by the total amount of milk weighed in grams less the total amount of milk not used. Each caregiver-infant pair will be provided with a bib cloth for each observed feeding. The bib cloth will be weighed before and after each feed and the weights recorded on the Feeding Assessment form. The difference between the pre and post weights will be used as the measure of the amount spilled. A digital scale will be used to measure the milk weight, which will be recorded in grams.|24-36 hours||||percentage of feed spilled||Standard Deviation|Mean
2533061|NCT03280381|Primary|Caregiver Satisfaction [Immediate]|Caregiver's satisfaction will be the cup she prefers, which will be recorded in the In-Hospital Preference Survey completed after the caregiver has finished the feeding portion of the study. Data refers to number of caregivers who prefer the Nifty Cup.|24-36 hours||||participants|||Number
2533062|NCT03280108|Secondary|Rate of Most Bothersome Visual Disturbances as Reported by the Subject Using the QUVID|"Subjects were asked if they experienced any of the visual disturbances in the past 7 days from when the questionnaire was conducted and to answer how much the disturbance bothered them on a scale from 0-4, where 0=not bothered at all and 4=bothered very much. The percentage of subjects with most bothersome visual disturbances was calculated as (# of subjects responding Bothered very much) divided by (# of subjects with bilateral implantation and non-missing data in the specified category) times 100. Hypothesis testing was not planned for this outcome measure."|Month 6 (Day 120-180), post second eye implantation|This analysis population includes all subjects with bilateral implantation and non-missing data.|||Participants|||Count of Participants
2533075|NCT03278106|Other Pre-specified|Circulating Tumor Cells (CTCs) or Cell-free Deoxyribonucleic Acid (DNA) (cfDNA) Analysis at Baseline|Will determine if CTCs or cfDNA at baseline will correlate with prognosis or response to therapy.|Baseline|||||||
2533076|NCT03278106|Other Pre-specified|Change in Circulating Tumor Cells (CTCs) or Cell-free Deoxyribonucleic Acid (DNA) (cfDNA)|Will correlate with efficacy endpoints.|Baseline up to 3 years|||||||
2533065|NCT03280108|Secondary|Mean Photopic Monocular Distance Corrected Visual Acuity at Intermediate (66 cm)|VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 66 cm m from the eye. Monocular distance corrected visual acuity at intermediate was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.|Month 6 (Day 120-180), post second eye implantation|All-Implanted Analysis Set with data at visit|||logMAR|Eyes|Standard Error|Least Squares Mean
2533066|NCT03280108|Primary|Mean Mesopic With Glare Binocular Distance Contrast Sensitivity|Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.|Month 6 (Day 120-180), post second eye implantation|Safety Analysis Set with contrast sensitivity test|||log units||Standard Deviation|Mean
2533067|NCT03280108|Primary|Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity|Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under mesopic (dimly-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.|Month 6 (Day 120-180), post second eye implantation|Safety Analysis Set with contrast sensitivity test|||log units||Standard Deviation|Mean
2533068|NCT03280108|Primary|Mean Photopic With Glare Binocular Distance Contrast Sensitivity|Contrast sensitivity was assessed binocularly with the subject's best spectacle correction under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cpd using the Vector Vision CSV 1000-HGT with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.|Month 6 (Day 120-180), post second eye implantation|Safety Analysis Set with contrast sensitivity test|||log units||Standard Deviation|Mean
2533069|NCT03280108|Primary|Mean Photopic Without Glare Binocular Distance Contrast Sensitivity|Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly (both eyes together) with the subject's best spectacle correction under photopic (well-lit) conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, and 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Subjects who were unable to see a targeted spatial frequency at any available contrast, including that of the reference patch, were assigned the lowest measurable value. A higher numeric value represents better contrast sensitivity. Hypothesis testing was not planned for this outcome measure.|Month 6 (Day 120-180), post second eye implantation|Safety Analysis Set with contrast sensitivity test|||log units||Standard Deviation|Mean
2533070|NCT03280108|Primary|Cumulative Rate of Secondary Surgical Interventions (SSI) Related to Optical Properties of the IOL, First Eye|The number of SSI's related to the optical properties of the IOL was calculated from time of implantation up to Month 6. The percentage was calculated as (# of eyes with an SSI related to the optical properties of the IOL) divided by (# of eyes with attempted IOL implantation, successful or aborted after contact with the eye) times 100. SSI's could include, but were not limited to, IOL replacement, IOL explantation, IOL repositioning, refractive laser treatment, paracentesis, vitreous aspirations, iridectomy or laser iridotomy for pupillary block, wound leak repair, and retinal detachment repair. No hypothesis testing was planned for this outcome measure.|Up to Month 6 (Day 120-180), post second eye implantation|This analysis population includes all eyes with attempted (successful or aborted after contact with the eye) IOL implantation (Safety Analysis Set).|||Eyes|Eyes||Count of Units
2533071|NCT03280108|Primary|Mean Photopic Monocular Distance Corrected Visual Acuity at Near (40 cm)|VA was tested monocularly under photopic conditions using the manifest refraction adjusted for optical infinity and 100% contrast electronic ETDRS charts at a distance of 40 centimeters (cm) from the eye. Distance corrected visual acuity at near was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.|Month 6 (Day 120-180), post second eye implantation|All-Implanted Analysis Set with data at visit|||logMAR|Eyes|Standard Error|Least Squares Mean
2533072|NCT03280108|Primary|Mean Photopic Monocular Best Corrected Distance Visual Acuity (4 m)|Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.|Month 6 (Day 120-180), post second eye implantation|All-Implanted Analysis Set with data available at the visit|||logMAR||Standard Error|Least Squares Mean
2533073|NCT03279458|Primary|Tidal Volume of Each Breath Was Measured Using the Same Breathing Mask CPAP Apparatus Combined With Respiratory Monitoring Device Allowing for Simultaneous Recording.|Tidal volume measured by CPAP mask with Lishom respiratory monitoring device. Tidal volume determined from the ventilator will be compared to tidal volume measured by Linshom (calculated indirectly by temperature changes by computer algorithm)|5 minutes|Thirty participants successfully completed the experiment, which involved breathing through a CPAP mask in order to have the Linshom device record excursions of the thermistor tracings while the ventilator concurrently measured tidal volume.|||ml||95% Confidence Interval|Least Squares Mean
2533077|NCT03278106|Secondary|Overall Toxicity Rates (Percentages) for Grade 3 or Higher Adverse Events Considered at Least Possibly Related to Treatment, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)|"The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below."|Up to 3 years||||percentage of patients|||Number
2533078|NCT03278106|Secondary|Overall Survival (OS)|OS will be estimated using the Kaplan-Meier method. OS is defined as the time from study entry to death from any cause. Patients will be censored at the date patient was last known to be alive. The median OS and 95% confidence interval will be reported.|Time from study entry to death from any cause, assessed up to 3 years||||months||95% Confidence Interval|Median
2533079|NCT03278106|Secondary|Progression-free Survival (PFS)|PFS will be estimated using the Kaplan-Meier method. Progression-Free Survival (PFS) is defined as the time from study entry to the first of either disease progression or death from any cause, where disease progression will be determined based on RECIST 1.1 criteria. Patients will be censored at the last disease assessment date. The median PFS and 95% confidence interval will be reported.|Time from study entry to the first of either disease progression or death from any cause, assessed up to 3 years||||months||95% Confidence Interval|Median
2533080|NCT03278106|Secondary|Overall Response Rate (ORR)|ORR defined as the percentage of patients who experience either a partial response or complete response by the given time point. Complete Response (CR):All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to <1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the BSD.|Up to 3 years||||percentage of patients||95% Confidence Interval|Number
2533081|NCT03278106|Primary|16-Week Progression-free Survival (PFS) Rate|16-Week Progression-free survival (PFS) rate is defined as the percentage of patients who are progression-free (stable disease, partial response, or complete response as defined by RECIST v1.1 criteria) at 16 weeks post registration.|16 weeks|Primary analysis population|||percentage of patients||95% Confidence Interval|Number
2533082|NCT03278067|Secondary|Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any SAEs in EHR (combining routine data collection and card-based ADR reporting system)~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533083|NCT03278067|Secondary|Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any SAEs in EHR (combining routine data collection and card-based ADR reporting system)within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533084|NCT03278067|Secondary|Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533235|NCT03276078|Primary|%Fluctuation of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).|Fluctuation index during a dosing interval estimated as 100*(Cmax-Cmin)/Cav (%).|Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5|Pharmacokinetic analysis set: All participants who took at least one dose of the IP and had at least one of the parameters (Cmax, Css,max, AUC, AUClast or AUCss,tau) evaluable and were assumed not to be affected by factors such as important protocol deviations.|||Percentage||Standard Deviation|Mean
2566939|NCT02573779|Primary|Head Circumference Growth|Growth in head circumference will be measured weekly (defined as cm/wk)|6-10 weeks||||cm/week||Standard Deviation|Mean
2533085|NCT03278067|Secondary|Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533086|NCT03278067|Secondary|Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533087|NCT03278067|Secondary|Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533088|NCT03278067|Secondary|Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533089|NCT03278067|Secondary|Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533236|NCT03276078|Primary|Cav of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).|Average plasma concentration during a dosing interval, estimated as AUC(ss,tau)/12|Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5|Pharmacokinetic analysis set: All participants who took at least one dose of the IP and had at least one of the parameters (Cmax, Css,max, AUC, AUClast or AUCss,tau) evaluable and were assumed not to be affected by factors such as important protocol deviations.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2539018|NCT03086265|Secondary|Count of Participants Requiring Jet Ventilation|Jet ventilation refers to delivery of oxygen via high pressure jet ventilator.|Duration of surgery (average approximately 1 hour)||||Participants|||Count of Participants
2533090|NCT03278067|Secondary|Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533091|NCT03278067|Secondary|Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533092|NCT03278067|Secondary|Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533093|NCT03278067|Secondary|Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533094|NCT03278067|Secondary|Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533535|NCT03266172|Primary|Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of GSK2982772 in IR Formulation : Part A|Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t)|Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose|PK Population.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533095|NCT03278067|Secondary|Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533096|NCT03278067|Secondary|Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533097|NCT03278067|Secondary|Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533098|NCT03278067|Secondary|Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533099|NCT03278067|Secondary|Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533237|NCT03276078|Primary|Vz/F of Aclidinium Bromide and Formoterol Fumarate (Multiple Doses).|Apparent volume of distribution for parent drug at terminal phase, estimated by dividing the apparent clearance (CL/F) by λz.|Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5|Pharmacokinetic analysis set: All participants who took at least one dose of the IP and had at least one of the parameters (Cmax, Css,max, AUC, AUClast or AUCss,tau) evaluable and were assumed not to be affected by factors such as important protocol deviations.|||L||Standard Deviation|Mean
2533100|NCT03278067|Secondary|Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533101|NCT03278067|Secondary|Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533102|NCT03278067|Secondary|Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and UK CMO-specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533103|NCT03278067|Secondary|Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533104|NCT03278067|Secondary|Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group|"SAEs reported here are derived from 2 sources of data - ADR cards and SAEs routinely collected from GPs. SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533238|NCT03276078|Primary|CL/F of Aclidinium Bromide and Formoterol Fumarate (Multiple Doses).|Apparent plasma clearance for parent drug estimated as dose divided by AUCss|Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5|Pharmacokinetic analysis set: All participants who took at least one dose of the IP and had at least one of the parameters (Cmax, Css,max, AUC, AUClast or AUCss,tau) evaluable and were assumed not to be affected by factors such as important protocol deviations.|||L/hour||Standard Deviation|Mean
2539021|NCT03086265|Primary|Time to Suspension|Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to full surgical suspension.|Duration of surgery (average approximately 1 hour)||||minutes||Standard Deviation|Mean
2533105|NCT03278067|Secondary|Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine and Age Group|"SAEs reported here are derived from 2 sources of data - ADR cards and SAEs routinely collected from GPs. SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533106|NCT03278067|Secondary|Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group|"AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between weeks 35 and 48 of 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533107|NCT03278067|Secondary|Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine and Age Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between weeks 35 and 48 of 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533108|NCT03278067|Secondary|Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533109|NCT03278067|Secondary|Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine and Age Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533570|NCT03265132|Secondary|Time to Study Drug Discontinuation for Any Reason.|Time to study drug discontinuation was analyzed using Kaplan-Meier curves. Number of patients with premature study drug discontinuation for any reason is reported here.|From Day 1 to Week12||||Participants|||Count of Participants
2533110|NCT03278067|Secondary|Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533111|NCT03278067|Secondary|Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine and Age Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533112|NCT03278067|Secondary|Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group|"AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between weeks 35 and 48 of 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533113|NCT03278067|Secondary|Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine and Age Group|"AEIs reported here are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between weeks 35 and 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533114|NCT03278067|Secondary|Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea and vomiting. The cumulative incidence rates of AEIs expressed as a cumulative percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system); The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine.~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533293|NCT03271424|Primary|Qualitative Summaries of Participant Experience in Focus Group Discussions|Qualitative Summaries for recruitment of peers/sex partners, issues related to privacy and spaces for testing, options for post-test counseling, optimizing return visits, and preferences for contact|6 months post study start||||number of times reported in FGD|||Number
2533115|NCT03278067|Secondary|Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine and Age Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533116|NCT03278067|Secondary|Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and >65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhea, and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (routine data collection + ADR) within 7 days following vaccination with seasonal influenza vaccine~Vaccination of the subjects happened between weeks 35 and 48, 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533117|NCT03278067|Secondary|Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine and Age Group|"AEIs reported are derived from 2 data sources: ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and >65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhea, and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator = the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator = the number of subjects from the denominator who reported any AEIs in EHR (routine data collection + card-based ADR reporting system) within 7 days following vaccination with seasonal influenza vaccine~Vaccination happened between weeks 35 and 48, of 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533118|NCT03278067|Secondary|Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533119|NCT03278067|Secondary|Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine and Age Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2566940|NCT02573779|Primary|Linear Growth|Linear growth will be measured weekly (defined as cm/week)|6-10 weeks||||cm/week||Standard Deviation|Mean
2533120|NCT03278067|Secondary|Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533121|NCT03278067|Secondary|Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine and Age Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533122|NCT03278067|Secondary|Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group|"AEIs reported here are derived from 2 data sources - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12, 13 to 17, 18 to 65, and >65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between weeks 35 and 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533123|NCT03278067|Secondary|Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine and Age Group|"AEIs reported here are derived from 2 data sources - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years, and >65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with seasonal influenza vaccine~Vaccination of subjects happened between weeks 35 and 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533124|NCT03278067|Secondary|Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533295|NCT03271021|Secondary|IGA Treatment Success (Dichotomized as Yes/no) at Week 6, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 6||6 weeks||||participants|||Number
2533296|NCT03271021|Secondary|The Absolute Change From Baseline in the Inflammatory Lesion Count at the Interim Visit at Week 6||6 weeks||||Lesion Count||95% Confidence Interval|Least Squares Mean
2533125|NCT03278067|Secondary|Weekly Incidence Rates of Any AEIs Recorded in EHR, by Vaccine and Age Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533126|NCT03278067|Secondary|Cumulative Incidence Rates of SAEs Recorded in EHR, by Vaccine Group|"SAEs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533127|NCT03278067|Secondary|Cumulative Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533128|NCT03278067|Secondary|Cumulative Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533129|NCT03278067|Secondary|Cumulative Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533212|NCT03278067|Primary|Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group|"The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533130|NCT03278067|Secondary|Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533131|NCT03278067|Secondary|Cumulative Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533132|NCT03278067|Secondary|Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533133|NCT03278067|Secondary|Cumulative Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533134|NCT03278067|Secondary|Cumulative Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533228|NCT03276078|Secondary|Treatment-emergent AEs Related to Clinical Laboratory Parameters (Urinalysis)|Assessment of the safety in terms of urinalysis parameters after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.|Screening (Day -21) to Follow-up visit (Days 8-12)|Safety analysis set: All participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2533297|NCT03271021|Secondary|The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 9||9 weeks||||Lesion Count||95% Confidence Interval|Least Squares Mean
2533298|NCT03271021|Secondary|The Absolute Change From Baseline in the Non-inflammatory Lesion Count at Week 12||12 weeks||||Lesion Count||95% Confidence Interval|Least Squares Mean
2533135|NCT03278067|Secondary|Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group|"subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533136|NCT03278067|Secondary|Cumulative Incidence Rates of Any AEIs Recorded in EHR, by Vaccine Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start up to end of the week of interest and were registered in EHR (routine data collection & card-based ADR reporting) during FU period (from vaccination up to 7 days post-vaccination)|||Percentage of subjects||95% Confidence Interval|Number
2533137|NCT03278067|Secondary|Weekly Incidence Rates of SAEs Recorded in EHR, by Vaccine Group|"SAEs reported here are derived from 2 sources of data - ADR cards and SAE routinely collected from GPs. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any SAEs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533138|NCT03278067|Secondary|Weekly Incidence Rates of Neurological Adverse Events Recorded in EHR, by Vaccine Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533139|NCT03278067|Secondary|Weekly Incidence Rates of Musculoskeletal Adverse Events Recorded in EHR, by Vaccine Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533163|NCT03278067|Primary|Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533140|NCT03278067|Secondary|Weekly Incidence Rates of Rash Adverse Events Recorded in EHR, by Vaccine Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533141|NCT03278067|Secondary|Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Recorded in EHR, by Vaccine Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533142|NCT03278067|Secondary|Weekly Incidence Rates of Gastrointestinal Adverse Events Recorded in EHR, by Vaccine Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533143|NCT03278067|Secondary|Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Recorded in EHR, by Vaccine Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533144|NCT03278067|Secondary|Weekly Incidence Rates of General Non-specific Symptoms Recorded in EHR, by Vaccine Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533229|NCT03276078|Secondary|Treatment-emergent AEs Related to Clinical Laboratory Parameters (Haematology)|Assessment of the safety in terms of haematology parameters after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.|Screening (Day -21) to Follow-up visit (Days 8-12)|Safety analysis set: All participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2533299|NCT03271021|Primary|Investigator Global Assessment (IGA) Treatment Success (Dichotomized as Yes/no) at Week 12, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline||12 weeks||||participants|||Number
2533145|NCT03278067|Secondary|Weekly Incidence Rates of Local Symptoms Recorded in EHR, by Vaccine Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533146|NCT03278067|Secondary|Weekly Incidence Rates of Fever/Pyrexia Adverse Events Recorded in EHR, by Vaccine Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from GPs. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533147|NCT03278067|Secondary|Weekly Incidence Rates of Any AEIs Recorded in Electronic Health Record (EHR), by Vaccine Group|"AEIs reported here are derived from 2 sources of data - ADR cards and AEI routinely collected from General Practitioners (GPs). The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who were registered in EHR (combining routine data collection and card-based ADR reporting system)~The numerator was the number of subjects from the denominator who reported any AEIs in EHR (combining routine data collection and card-based ADR reporting system) within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in EHR (combining routine data collection and card-based ADR reporting system) during the safety follow-up period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533148|NCT03278067|Primary|Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533149|NCT03278067|Primary|Weekly Incidence Rates of SAEs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533150|NCT03278067|Primary|Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533300|NCT03271021|Primary|The Absolute Change From Baseline in the Inflammatory Lesion Count at Week 12.|A decrease in the inflammatory lesion count from Baseline to Week 12.|12 weeks||||Lesion Count||95% Confidence Interval|Least Squares Mean
2533151|NCT03278067|Primary|Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533152|NCT03278067|Primary|Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533153|NCT03278067|Primary|Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533154|NCT03278067|Primary|Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533155|NCT03278067|Primary|Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533156|NCT03278067|Primary|Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533230|NCT03276078|Secondary|Treatment-emergent AEs Related to Blood Pressure|Assessment of the safety in terms of notable changes from baseline in blood pressure after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.|Screening (Day -21) to Follow-up visit (Days 8-12)|Safety analysis set: All participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2533571|NCT03265132|Secondary|Change From Baseline in Patient/Parent Global Assessment of Disease Related Pain.|Assessed on a VAS from no pain (0 mm) to very severe pain (100 mm).|Week 2|Patients with baseline and week 2 data analyzed.|||score on a scale||Standard Deviation|Mean
2533157|NCT03278067|Primary|Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533158|NCT03278067|Primary|Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533159|NCT03278067|Primary|Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533160|NCT03278067|Primary|Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533161|NCT03278067|Primary|Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533162|NCT03278067|Primary|Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533572|NCT03265132|Secondary|Change From Baseline in Ferritin.|Change from baseline in ferritin. Results at Week 2 reported here.|Week 2||||ug/L||Standard Deviation|Mean
2533164|NCT03278067|Primary|Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533165|NCT03278067|Primary|Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533166|NCT03278067|Primary|Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533167|NCT03278067|Primary|Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533168|NCT03278067|Primary|Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and UK CMO-specified Risk Status|"The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533169|NCT03278067|Primary|Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine Group and United Kingdom Chief Medical Officer (UK CMO)-Specified Risk Status|"The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533231|NCT03276078|Secondary|Adverse Events (AEs)/Serious AEs (SAEs)|Assessment of the safety in terms of the incidences of AEs/SAEs after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.|Screening (Day -21) to Follow-up visit (Days 8-12)|Safety analysis set: All participants who received at least one dose of the investigational product.|||Participants|||Count of Participants
2533407|NCT03268005|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 16. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period was from date of randomisation and until last trial-related participant-site contact.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2533170|NCT03278067|Primary|Cumulative Incidence Rates of SAEs Reported Via ADR Card, by Vaccine and Age Group|"SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533171|NCT03278067|Primary|Weekly Incidence Rates of Serious Adverse Events (SAEs) Reported Via ADR Card, by Vaccine and Age Group|"SAE data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533172|NCT03278067|Primary|Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533173|NCT03278067|Primary|Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533174|NCT03278067|Primary|Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533175|NCT03278067|Primary|Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533573|NCT03265132|Secondary|Change From Baseline in Platelet Count.|Change from baseline in platelet count. Results at Week 2 reported here.|Week 2||||10^9/L||Standard Deviation|Mean
2533176|NCT03278067|Primary|Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533177|NCT03278067|Primary|Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533178|NCT03278067|Primary|Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533179|NCT03278067|Primary|Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial oedema and hypersensitivity reactions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533180|NCT03278067|Primary|Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533181|NCT03278067|Primary|Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhoea, nausea and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2539137|NCT03079375|Secondary|Drug-related Readmissions|number of patients who have drug related readmissions|30 days after the inclusion date||||Participants|||Count of Participants
2533182|NCT03278067|Primary|Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533183|NCT03278067|Primary|Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533184|NCT03278067|Primary|Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533185|NCT03278067|Primary|Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533186|NCT03278067|Primary|Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533187|NCT03278067|Primary|Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533188|NCT03278067|Primary|Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533189|NCT03278067|Primary|Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533190|NCT03278067|Primary|Cumulative Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533191|NCT03278067|Primary|Weekly Incidence Rates of Any AEIs Reported Via ADR Card, by Vaccine and Age Group|"AEI data was presented by age strata: 6 months to 5 years, 6 to 12 years, 13 to 17 years, 18 to 65 years and >65 years. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533192|NCT03278067|Primary|Cumulative Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group|"The cumulative incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card;~The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine.~Vaccination of the subjects happened between week 35 and week 48 of the year 2017."|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533193|NCT03278067|Primary|Weekly Incidence Rates of SAEs Reported Via ADR Card by Vaccine Group|"The weekly incidence rates of SAEs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card;~The numerator was the number of subjects from the denominator who reported any SAEs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine.~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533232|NCT03276078|Primary|Rac(Cmin) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).|"Accumulation ratio for Cmin estimated as Css,min on Day 5/Cmin on Day 1.~Additional parameters may be determined where appropriate."|Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5|Pharmacokinetic analysis set: All participants who took at least one dose of the IP and had at least one of the parameters (Cmax, Css,max, AUC, AUClast or AUCss,tau) evaluable and were assumed not to be affected by factors such as important protocol deviations.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2533194|NCT03278067|Primary|Cumulative Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group|"Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533195|NCT03278067|Primary|Weekly Incidence Rates of Neurological Adverse Events Reported Via ADR Card, by Vaccine Group|"Neurological adverse events include any neurological adverse events, Bell's palsy, Guillain-Barre Syndrome, peripheral tremor and seizure/febrile convulsions. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533196|NCT03278067|Primary|Cumulative Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group|"Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533197|NCT03278067|Primary|Weekly Incidence Rates of Musculoskeletal Adverse Events Reported Via ADR Card, by Vaccine Group|"Musculoskeletal adverse events include any musculoskeletal adverse events, arthropathy, and muscle aches/myalgia. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533198|NCT03278067|Primary|Cumulative Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group|"The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533199|NCT03278067|Primary|Weekly Incidence Rates of Rash Adverse Events Reported Via ADR Card, by Vaccine Group|"The weekly incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533233|NCT03276078|Primary|Rac[AUC(Tau)] of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).|Accumulation ratio for AUC(tau) estimated as AUC(ss,tau) on Day 5/AUC(tau) on Day 1|Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5|Pharmacokinetic analysis set: All participants who took at least one dose of the IP and had at least one of the parameters (Cmax, Css,max, AUC, AUClast or AUCss,tau) evaluable and were assumed not to be affected by factors such as important protocol deviations.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2533419|NCT03267940|Secondary|Expansion Portion: OS by PD-L1 Expression Levels|Overall survival was defined as the time from randomization until death from any cause.|From randomization until death from any cause (maximum exposure: 421 days)|This data was not collected as an endpoint but all deaths due to any cause are reported in the AE module.||||||
2533200|NCT03278067|Primary|Cumulative Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group|"Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The cumulative incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533201|NCT03278067|Primary|Weekly Incidence Rates of Sensitivity/Anaphylaxis Adverse Events Reported Via ADR Card, by Vaccine Group|"Sensitivity/anaphylaxis adverse events include any sensitivity/anaphylaxis adverse events, anaphylactic reactions, facial edema, and hypersensitivity reactions. The weekly incidence rates expressed as the percentage of subjects, of AEIs were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533202|NCT03278067|Primary|Cumulative Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group|"Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea and, vomiting. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533203|NCT03278067|Primary|Weekly Incidence Rates of Gastrointestinal Adverse Events Reported Via ADR Card, by Vaccine Group|"Gastrointestinal adverse events include any gastrointestinal adverse events, decreased appetite, diarrhea, nausea, and vomiting. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533204|NCT03278067|Primary|Cumulative Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group|"Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533205|NCT03278067|Primary|Weekly Incidence Rates of Respiratory/Miscellaneous Adverse Events Reported Via ADR Card, by Vaccine Group|"Respiratory/miscellaneous adverse events include any respiratory/miscellaneous adverse events, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533420|NCT03267940|Secondary|Expansion Portion: Overall Survival (OS)|Overall survival was defined as the time from randomization until death from any cause.|From randomization until death from any cause (maximum exposure: 421 days)|This data was not collected as an endpoint but all deaths due to any cause are reported in the AE module.||||||
2533206|NCT03278067|Primary|Cumulative Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group|"General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533207|NCT03278067|Primary|Weekly Incidence Rates of General Non-specific Symptoms Reported Via ADR Card, by Vaccine Group|"General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, headache, irritability, and malaise. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533208|NCT03278067|Primary|Cumulative Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group|"Local symptoms include local erythema. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533209|NCT03278067|Primary|Weekly Incidence Rates of Local Symptoms Reported Via ADR Card, by Vaccine Group|"Local symptoms include local erythema. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533210|NCT03278067|Primary|Cumulative Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group|"Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The cumulative incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Cumulative vaccinated cohort up to the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Cumulative vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine at any point from study start, up to end of the week of interest and were registered in EHR, using card-based ADR reporting system during the safety FU period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533211|NCT03278067|Primary|Weekly Incidence Rates of Fever/Pyrexia Adverse Events Reported Via ADR Card, by Vaccine Group|"Fever/pyrexia = all subjects with a fever/pyrexia read code recorded were considered as having fever/pyrexia, regardless of what temperature had been recorded. The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533234|NCT03276078|Primary|Rac(Cmax) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).|Accumulation ratio for Cmax estimated as Css,max on Day 5/Cmax on Day 1|Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5|Pharmacokinetic analysis set: All participants who took at least one dose of the IP and had at least one of the parameters (Cmax, Css,max, AUC, AUClast or AUCss,tau) evaluable and were assumed not to be affected by factors such as important protocol deviations.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2533574|NCT03265132|Secondary|Change From Baseline in Hemoglobin (Hb). Results at Week 2 Reported Here.|Change from baseline in Hemoglobin (Hb). Results at Week 2 reported here.|Week 2||||g/dL||Standard Deviation|Mean
2533213|NCT03278067|Primary|Weekly Incidence Rates of Any Adverse Events of Interest (AEIs) Reported Via Adverse Drug Reaction (ADR) Card, by Vaccine Group|"The weekly incidence rates of AEIs expressed as the percentage of subjects, were estimated as follows:~The denominator was the number of subjects in the Weekly vaccinated cohort for the week of interest who received the ADR card~The numerator was the number of subjects from the denominator who reported any AEIs on the ADR card within 7 days following vaccination with the seasonal influenza vaccine~Vaccination of the subjects happened between week 35 and week 48 of the year 2017"|Within 7 days post vaccination|Analysis was performed on the Weekly Vaccinated cohort which included all subjects who were vaccinated with a seasonal influenza vaccine during the week of interest and were registered in electronic health record (EHR), using card-based ADR reporting system during the safety follow-up (FU) period (from vaccination up to 7 days post-vaccination).|||Percentage of subjects||95% Confidence Interval|Number
2533214|NCT03278028|Primary|Physician's Wart Assessment|"Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated.~Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length)~A visible wart ≥ 3 mm and < 6 mm in maximal diameter (or length)~A visible wart ≥ 6 mm in maximal diameter (or length)"|Day 57|Per-Protocol (PP)|||score on a scale||Standard Deviation|Mean
2533215|NCT03277846|Primary|Treatment Response|"Percent responders to TES treatment and Sham TES (50% reduction or a score below 10 on the PHQ-9). The PHQ-9 is a 9 item scale, where each item ranges from 0 to 3. Zero represents not at all and 3 represents nearly every day. The scale ranges from 0-27. We used percent change (from admission to ex-take) as a our metric."|1-2 weeks|101 were enrolled. 78 subjects were in study for the minimum time / minimum number of treatments and provided the full compliment of data.|||Participants|||Count of Participants
2533216|NCT03277274|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)||Baseline up to 30 days after last dose of study drug (Day 31)|The safety set consisted of all participants who were enrolled and received the study drug.|||Participants|||Count of Participants
2533217|NCT03277274|Secondary|Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values||Up to 14 days after the last dose of study drug (Day 15)|The safety set consisted of all participants who were enrolled and received the study drug.|||Participants|||Count of Participants
2533218|NCT03277274|Secondary|Number of Participants With Markedly Abnormal Values of Vital Signs||Up to 14 days after the last dose of study drug (Day 15)|The safety set consisted of all participants who were enrolled and received the study drug.|||Participants|||Count of Participants
2533219|NCT03277274|Secondary|Number of Participants With Markedly Abnormal Electrocardiograms (ECGs)||Up to 14 days after the last dose of study drug (Day 15)|The safety set consisted of all participants who were enrolled and received the study drug.|||Participants|||Count of Participants
2533220|NCT03277274|Secondary|Number of Participants With Clinically Significant Physical Examination Findings||Up to 14 days after the last dose of study drug (Day 15)|The safety set consisted of all participants who were enrolled and received the study drug.|||Participants|||Count of Participants
2533221|NCT03277274|Primary|AUC∞: Area Under the Concentration-time Curve From Time 0 to Infinity for TAK-954 (Total and Free)||Day 1 pre-infusion and at multiple time points (up to 96 hours) post-infusion|The PK set consisted of all participants who were enrolled and received the correct dose of study drug and had at least 1 measurable plasma concentration or amount of drug in the urine for TAK-954.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2533222|NCT03277274|Primary|AUClast: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 (Total and Free)||Day 1 pre-infusion and at multiple time points (up to 96 hours) post-infusion|The PK set consisted of all participants who were enrolled and received the correct dose of study drug and had at least 1 measurable plasma concentration or amount of drug in the urine for TAK-954.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2533223|NCT03277274|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free)||Day 1 pre-infusion and at multiple time points (up to 96 hours) post-infusion|The pharmacokinetic (PK) set consisted of all participants who were enrolled and received the correct dose of study drug and had at least 1 measurable plasma concentration or amount of drug in the urine for TAK-954.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2533224|NCT03276494|Secondary|Pain Scale|"Pain (CPOT-critical care pain observation tool). All non-verbal subjects have pain assessed with a CPOT score, as observed by clinicians. The CPOT is a validated pain score for nonverbal patients. This tool assesses pain with nonverbal indicators, adding 1-2 points for several nonverbal indicators of pain, 0 if the nonverbal indicator is absent, and is reported as a total summed score. It ranges from 0-8, with 0 indicating no pain and 8 indicating high pain.~No patients were verbal, so the numeric pain rating scale was not used for any patients."|24 hours||||units on a scale||Full Range|Median
2533225|NCT03276494|Primary|Number of Subjects With Tissue Damage|Number of subjects with tissue damage (e.g. Myonecrosis, Skin necrosis, Extravasation, Compartment syndrome, Osteomyelitis). These data points will be determined by clinician assessment.|24 hours||||Participants|||Count of Participants
2533226|NCT03276078|Secondary|Treatment-emergent AEs Related to 12-lead ECG Parameters|Assessment of the safety in terms of the 12-lead ECG parameters after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.|Screening (Day -21) to Follow-up visit (Days 8-12)|Safety analysis set: All participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2533227|NCT03276078|Secondary|Treatment-emergent AEs Related to Clinical Laboratory Parameters (Serum Biochemistry)|Assessment of the safety in terms of serum biochemistry parameters (Alanine aminotransferase [ALT], Aspartate aminotransferase [AST], alkaline phosphatase [ALP], Gamma-glutamyl transferase [GGT], bilirubin, creatine kinase, lactate dehydrogenase, urea nitrogen, creatinine, urate, cholesterol, glucose, sodium, potassium, calcium, chloride, phosphate, protein, and albumin) after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.|Screening (Day -21) to Follow-up visit (Days 8-12)|Safety analysis set: All participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2533575|NCT03265132|Secondary|Change From Baseline in CRP.|Change from baseline in CRP. Results at Week 2 reported here.|Week 2||||mg/L||Standard Deviation|Mean
2533239|NCT03276078|Primary|AUC(ss,Tau) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).|Area under the plasma concentration curve during the dosing interval, tau at steady state.|Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5|Pharmacokinetic analysis set: All participants who took at least one dose of the IP and had at least one of the parameters (Cmax, Css,max, AUC, AUClast or AUCss,tau) evaluable and were assumed not to be affected by factors such as important protocol deviations.|||pg*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2533240|NCT03276078|Primary|t½λz of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).|Terminal half-life (h), estimated as (ln2)/λz.|Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5|Pharmacokinetic analysis set: All participants who took at least one dose of the IP and had at least one of the parameters (Cmax, Css,max, AUC, AUClast or AUCss,tau) evaluable and were assumed not to be affected by factors such as important protocol deviations.|||hours||Standard Deviation|Mean
2533241|NCT03276078|Primary|λz of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).|Terminal rate constant, estimated by log-linear least square regression of the terminal part of the concentration-time curve.|Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5|Pharmacokinetic analysis set: All participants who took at least one dose of the IP and had at least one of the parameters (Cmax, Css,max, AUC, AUClast or AUCss,tau) evaluable and were assumed not to be affected by factors such as important protocol deviations.|||1/hours||Standard Deviation|Mean
2533242|NCT03276078|Primary|Tss,Max of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).|Time to maximum concentration (h), taken directly from the individual concentration-time curve at steady state.|Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5|Pharmacokinetic analysis set: All participants who took at least one dose of the IP and had at least one of the parameters (Cmax, Css,max, AUC, AUClast or AUCss,tau) evaluable and were assumed not to be affected by factors such as important protocol deviations.|||hours||Full Range|Median
2533243|NCT03276078|Primary|Css,Min of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).|Observed minimum concentration, taken directly from the individual concentration-time curve within a dosing interval on Day 5.|Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5|Pharmacokinetic analysis set: All participants who took at least one dose of the IP and had at least one of the parameters (Cmax, Css,max, AUC, AUClast or AUCss,tau) evaluable and were assumed not to be affected by factors such as important protocol deviations.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2533244|NCT03276078|Primary|Css,Max of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).|Observed maximum concentration, taken directly from the individual concentration-time curve at steady state.|Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5|Pharmacokinetic analysis set: All participants who took at least one dose of the IP and had at least one of the parameters (Cmax, Css,max, AUC, AUClast or AUCss,tau) evaluable and were assumed not to be affected by factors such as important protocol deviations.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2533245|NCT03276078|Primary|AUC(Tau) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).|Area under the plasma concentration curve during the first dosing interval, tau (first dose).|Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1|Pharmacokinetic analysis set: All participants who took at least one dose of the IP and had at least one of the parameters (Cmax, Css,max, AUC, AUClast or AUCss,tau) evaluable and were assumed not to be affected by factors such as important protocol deviations.|||pg*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2533246|NCT03276078|Primary|AUC(Last) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).|Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration.|Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1|Pharmacokinetic analysis set: All participants who took at least one dose of the IP and had at least one of the parameters (Cmax, Css,max, AUC, AUClast or AUCss,tau) evaluable and were assumed not to be affected by factors such as important protocol deviations.|||pg*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2533247|NCT03276078|Primary|Cmin of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).|Minimum plasma drug concentration at the end of the dosing interval (first dose), where possible.|Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1|Pharmacokinetic analysis set: All participants who took at least one dose of the IP and had at least one of the parameters (Cmax, Css,max, AUC, AUClast or AUCss,tau) evaluable and were assumed not to be affected by factors such as important protocol deviations.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2533248|NCT03276078|Primary|Tmax of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).|Time to maximum concentration (h), taken directly from the individual concentration-time curve (first dose).|Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1|Pharmacokinetic analysis set: All participants who took at least one dose of the IP and had at least one of the parameters (Cmax, Css,max, AUC, AUClast or AUCss,tau) evaluable and were assumed not to be affected by factors such as important protocol deviations.|||hours||Full Range|Median
2533249|NCT03276078|Primary|Cmax of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).|Observed maximum concentration, taken directly from the individual concentration-time curve (first dose).|Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1|Pharmacokinetic analysis set: All participants who took at least one dose of the IP and had at least one of the parameters (Cmax, Css,max, AUC, AUClast or AUCss,tau) evaluable and were assumed not to be affected by factors such as important protocol deviations.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2533250|NCT03276026|Secondary|Incidence of Respiratory Complications|Assess the incidence of respiratory complications postoperatively specifically looking at oxygen saturation at patient arrival to the post anesthesia care unit and every 15 minutes after arrival to the post anesthesia care unit and any intervention necessary.|Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).||||Participants|||Count of Participants
2533251|NCT03276026|Secondary|Incidence of Postoperative Nausea and Vomiting|Assess the incidence of Postoperative Nausea and Vomiting in the American Society of Anesthesiologists Score II and III patients reversed with Sugammadex versus Neostigmine at arrival to the post anesthesia care unit and every 15 minutes while in the post anesthesia care unit, with the prediction that there will be a lower incidence of Postoperative Nausea and Vomiting in the Sugammadex group.|Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).||||Participants|||Count of Participants
2533252|NCT03276026|Primary|Post Anesthesia Care Unit Length of Stay|Determine the difference in length of stay in the post anesthesia care unit from patient arrival until ready for post anesthesia care discharge for the American Society of Anesthesiologists Score II and III patients reversed with Sugammadex versus Neostigmine in sleeve gastrectomy surgeries.|Observations will be made during each patient's stay in the post anesthesia care unit (about 120 minutes).||||minutes||Full Range|Mean
2533253|NCT03275870|Secondary|Change in Quality of Life|Comparison of baseline and post-treatment self-reported quality of life Dermatology Life Quality Index score: minimum 0, maximum 30. higher scores mean worse outcome.|6 months||||score on a scale||Standard Deviation|Mean
2533254|NCT03275870|Primary|Change in Disease Severity|Comparison of baseline and post-treatment Sartorius severity scoring Sartorius scoring: minimum 0, no maximum, higher scores mean a worse outcome|6 months||||score on a scale||Standard Deviation|Mean
2533255|NCT03275623|Primary|Number of Participants Who Have Pyelonephritis|Pyelonephritis is defined as a urine culture with >100,000 CFU with fever at any point during antenatal care.|about 10 months|"2 participants in the no antibiotic treatment arm and 5 in the antibiotic treatment arm were not assessed for this outcome measure."|||Participants|||Count of Participants
2533256|NCT03275623|Primary|Number of Participants Who Have Cystitis|Cystitis is defined as a urine culture with >100,000 CFU at any point during antenatal care.|about 10 months|"2 participants in the no antibiotic treatment arm and 5 in the antibiotic treatment arm were not assessed for this outcome measure."|||Participants|||Count of Participants
2533257|NCT03274986|Secondary|Percentage of Subjects With Visual Disturbances as Reported by the Subjects Using the Questionnaire for Visual Disturbances (QUVID)|Rates of severe and most bothersome visual disturbances as reported by the subjects on the QUVID questionnaire, a Patient Reported Outcome (PRO) questionnaire. No formal statistical hypothesis testing was planned.|Month 6 (120-180 days post second eye implantation)|Safety Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at specified visual disturbances.|||percentage of subjects|||Number
2533258|NCT03274986|Secondary|Monocular Photopic Uncorrected Distance Visual Acuity (UCDVA) (logMAR)|VA was tested monocularly under photopic conditions without refractive correction but with adjustment for optical infinity, electronic ETDRS charts at a distance of 4 m from the eye. +0.25 D spherical power was applied to correct for optical infinity. UCDVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA.This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.|Month 6 (120-180 days post second eye implantation)|All-Implanted Analysis Set, as treated.|||logMAR|Eyes|Standard Deviation|Mean
2533259|NCT03274986|Secondary|Monocular Photopic Uncorrected Intermediate Visual Acuity (UCIVA) (logMAR) 66 cm From Spectacle Plane|VA was tested monocularly under photopic conditions with no refractive correction or adjustment for optical infinity, using electronic ETDRS charts at a distance of 66 cm from the spectacle plane. UCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.|Month 6 (120-180 days post second eye implantation)|All-Implanted Analysis Set, as treated.|||logMAR|Eyes|Standard Deviation|Mean
2533260|NCT03274986|Secondary|"Percentage of Subjects Who Respond Never to Question 1 of the Intraocular Lens Satisfaction (IOLSAT) Questionnaire: Overall, in the Past 7 Days, How Often Did You Need to Wear Eyeglasses to See?"|The IOLSAT questionnaire assessed the subjective quality of vision with respect to need for spectacles, as well as the subject's expectation and satisfaction with their quality of vision at 6 months. Results are reported consistent with multiple testing strategy.|Month 6 (120-180 days post second eye implantation)|All-Implanted Analysis Set, as treated.|||percentage of subjects|||Number
2533261|NCT03274986|Secondary|Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) (logMAR) 40 cm From Spectacle Plane|VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS chart set at 40 cm from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.|Month 6 (120-180 days post second eye implantation)|All-Implanted Analysis Set, as treated.|||logMAR|Eyes|Standard Error|Least Squares Mean
2533262|NCT03274986|Primary|Mesopic Contrast Sensitivity|Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed monocularly with the subject's best spectacle correction under mesopic (low, but not quite dark) conditions at a distance of 8 (2.45 m) feet from the eye at a spatial frequency of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT with and without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. A higher numeric value represented better contrast sensitivity. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.|Month 6 (120-180 days post second eye implantation)|Safety Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at without glare and with glare assessments.|||log unit|Eyes|Standard Deviation|Mean
2533301|NCT03270657|Secondary|Number of Participants With Recorded Spontaneous, Local Field Potentials (LFPs).|Measured by the ability to record LFPs (electrical activity in the local region of the DBS electrode) through DBS electrodes using circuitry developed at Duke for this purpose and/or a new implantable pulse generator (IPG; RC+S) developed by Medtronic. These intraoperative studies will specifically test a preliminary version of the RC+S that is not designed for implantation.|End of procedure, approximately 45 minutes||||Participants|||Count of Participants
2533263|NCT03274986|Primary|Percentage of Subjects With Ocular Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular AEs are events localized to the eye. Cumulative and persistent serious adverse events as defined in ISO 11979-7:2014 were collected. This outcome measure was prespecified for the Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.|Day 0 (first operative eye visit), up to Month 6 (120-180 days post second eye implantation)|This analysis population included all eyes with attempted IOL implantation (successful or aborted after contact with the eye) (Safety Analysis Set).|||percentage of subjects|Eyes||Number
2533264|NCT03274986|Primary|Percentage of Eyes Achieving Monocular Photopic DCIVA 0.20 logMAR or Better|VA was tested monocularly under photopic conditions using best distance correction adjusted for optical infinity, electronic ETDRS charts at a distance of 66 cm from the eye. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye. No formal statistical hypothesis testing was planned.|Month 6 (120-180 days post second eye implantation)|All-Implanted Analysis Set, as treated.|||percentage of eyes|Eyes||Number
2533265|NCT03274986|Primary|Monocular Depth of Focus (Measured in the Negative Direction From 0) at 0.20 logMAR From the Mean Defocus Curve|Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction and added defocus. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified for the first operative eye. No formal statistical hypothesis testing was planned.|Month 6 (120-180 days post second eye implantation)|All-Implanted Analysis Set, as treated. Number analyzed is the number of subjects/eyes with data available for analysis at specified defocus.|||diopter|Eyes||Number
2533266|NCT03274986|Primary|Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) logMAR [(4 Meters (m)] From Spectacle Plane|VA was tested monocularly under photopic conditions using the correction obtained from the best correction and no optical infinity adjustment, electronic ETDRS charts at a distance of 4 m from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.|Month 6 (120-180 days post second eye implantation)|All-Implanted Analysis Set, as treated|||logMAR|Eyes|Standard Error|Least Squares Mean
2533267|NCT03274986|Primary|Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) [(Logarithm of the Minimum Angle of Resolution (logMAR)] 66 Centimeters (cm) From Spectacle Plane|Visual acuity (VA) was tested monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction adjusted for optical infinity, electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 66 cm from the spectacle plane. DCIVA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.|Month 6 (120-180 days post second eye implantation)|All-Implanted Analysis Set, as treated|||logMAR|Eyes|Standard Error|Least Squares Mean
2533268|NCT03274856|Secondary|Maximum Observed Drug Concentration (Cmax)|Pharmacokinetics after single and multiple oral dosing|Day 14 and Day 42, pre-dose, and 0.5, 1, 2, 4, 6, and between 8 and 12 hours postdose||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2533269|NCT03274856|Secondary|Area Under the Concentration Versus Time Curve From Time Zero to 12 Hours (AUC0-12)|Pharmacokinetics (PK) after single and multiple oral dosing|Day 14 and Day 42, pre-dose, and 0.5, 1, 2, 4, 6, and between 8 and 12 hours postdose|Because PK data were collected only during Treatment 1, and the patients were randomized 1:1 to GLWL-01 or placebo, PK data were available from 9 patients. Evaluable data only available to compute AUC for some participants|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2533270|NCT03274856|Secondary|Caregiver Global Impression of Change (CGIC)|GLWL-01 compared with placebo in the CGIC. Score ranges from 1 to 7, with larger number indicating a worse outcome.|Up to approximately 4 weeks of double-blind treatment||||score on a scale||Standard Error|Least Squares Mean
2533271|NCT03274856|Secondary|Number of Participants With One or More Treatment Emergent Adverse Events (AEs) or Any Serious AEs|Evaluate the safety and tolerability of GLWL-01|Baseline up to approximately 18 weeks||||Participants|||Count of Participants
2533272|NCT03274856|Primary|Post-treatment Total Score on the Hyperphagia Questionnaire for Clinical Trials (HQ-CT)|GLWL-01 compared with placebo on the post-treatment HQ-CT score. Total range of score of zero to 36, with higher score indicating a worse outcome.|Up to approximately 4 weeks of double-blind treatment||||score on a scale||Standard Error|Least Squares Mean
2533273|NCT03274518|Other Pre-specified|Fluid Status|noninvasive assessment of extracellular and total body water|One month after starting protocol||||liter/liter||Standard Deviation|Mean
2533274|NCT03274518|Secondary|Intradialytic Hemodynamics|noninvasive cardiac output assessment|Cardiac output (liters per minute) one month after starting protocol|Intradialytic cardiac output variation (post-pre dialysis), l/min|||l/min||Inter-Quartile Range|Median
2533275|NCT03274518|Primary|Medium Molecule Removal|Beta-2-Microglobulin extraction|One month after starting protocol|Beta-2-microglobulin mass extraction (mg)|||mg||Standard Deviation|Mean
2533276|NCT03274518|Primary|Medium Molecule Clearance|Beta-2-Microglobulin clearance|One month after starting protocol|Beta-2 Microglobulin clearance (ml/min)|||ml/min||Inter-Quartile Range|Median
2533277|NCT03274453|Primary|Hydromorphone Use/24 Hours postOP in mg/kg|Hydromorphone use during the first postoperative 24 hours in mg/kg|24 Hours||||mg/kg||Inter-Quartile Range|Mean
2533278|NCT03273946|Primary|Number of Participants With Any New, Unexpected AE or Safety Signal|An unexpected AE is defined as any adverse reaction whose nature and intensity have not been previously observed and documented for the study product (e.g. in the investigator brochure, product information). A safety signal is information on a new or known AE that may be caused by a medicine and requires further investigation. Number of participants with any new unexpected AE or safety signal are presented.|Up to Week 12|Safety Analysis Population|||Participants|||Count of Participants
2533279|NCT03273946|Primary|Number of Participants With Any Serious Adverse Event (SAE) or Non-SAE|Any untoward medical occurrence resulting in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, possible drug-induced liver injury or any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent serious outcomes were categorized as SAE. Number of participants who had at least one SAE or non-SAE are presented.|Up to Week 12|Safety Analysis Population|||Participants|||Count of Participants
2533280|NCT03273946|Primary|Number of Participants With Any Adverse Event (AE) or Adverse Drug Reaction (ADR)|An AE is defined as any untoward medical event which occurred in a participant or clinical study participant, which is temporally associated with the use of the medical product, whether or not considered related to the product. An ADR is defined as AE related to study drug and listed in the package insert. Number of participants who had at least one AE or ADR are presented.|Up to Week 12|Safety Analysis Population. It was defined as all the participants enrolled who received at least one dose of Flixotide 50 μg in clinical practice for appropriate medical use for the first time.|||Participants|||Count of Participants
2533281|NCT03273426|Secondary|False Negative Rate|Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR|2 weeks||||percentage of participants|||Number
2533282|NCT03273426|Primary|Negative Predictive Value|Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR|2 weeks|Number of participants with no tumor on biopsy|||percentage of participants||95% Confidence Interval|Number
2533283|NCT03273387|Secondary|Changes in Functional Capacity After 3 Month Intervention|"Functional capacity assessed by SF-36 score after 3 month intervention minus with functional capacity at baseline.~SF-36 functional capacity score scale 0 to 100 with better functional capacity along with higher score."|Baseline and 3 months after intervention||||score on a scale||Standard Error|Mean
2533284|NCT03273387|Secondary|Changes in Cardiac Fibrosis After 3 Months Intervention|Native T1 mapping (ms) assessed by Cardiac MRI at 3 months intervention minus with Native T1 at baseline.|Baseline and 3 months after intervention||||ms||Standard Error|Mean
2533285|NCT03273387|Primary|Changes in Right Ventricular Ejection Fraction (RVEF %) After 3 Months Intervention|Right ventricular ejection fraction (RVEF %) assessed by Cardiac MRI at 3 months intervention minus with RVEF at baseline.|Baseline and 3 months after intervention|A total 13 patients were assigned to each group equally. There were 6 patients who were not able to complete the study. A total of 2 patients from both group died due to RV failure. One patients from trimetazidine group withdrawn due to atypical angina and one patients from placebo group withdrawn due to claustrophobia.|||percentage of ejected blood||Standard Error|Mean
2533286|NCT03272711|Secondary|Participant Function|"Participant function assessed using the UCSD Performance-Based Skills Assessment (UPSA).~A validated test that required participants to demonstrate their competence to perform everyday functioning tasks in domains such as comprehension, planning, finances, transportation and communication. A higher scores indicates a better outcome. Scores can range from a minimum of 0 to a maximum of 100."|Randomization (0 weeks), 26 weeks||||score on a scale||Standard Deviation|Mean
2533287|NCT03272711|Secondary|Change in Total Fluid Cognitive Score|"Total fluid cognitive score from the NIH Toolbox as well as the speed of cognitive improvement The study utilized five cognitive tests from the NIH Toolbox Cognitive Battery that measured fluid cognition-the capacity for new learning and information processing. A higher score indicates indicates better performance on these tests. A total fluid cognitive score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest above-average fluid cognitive ability, while scores around 130 suggest superior ability. Conversely, a score around 85 suggests below-average fluid cognitive ability, and a score in the range of 70 or below suggests significant impairment."|Randomization (0 weeks), 4 week, 12 week, 26 week||||score on a scale||Standard Deviation|Mean
2533288|NCT03272711|Primary|Change in Total Fluid Cognitive Score|"Total fluid cognitive score from the NIH Toolbox as well as the speed of cognitive improvement The study utilized five cognitive tests from the NIH Toolbox Cognitive Battery that measured fluid cognition-the capacity for new learning and information processing. A higher score indicates indicates better performance on these tests. A total fluid cognitive score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest above-average fluid cognitive ability, while scores around 130 suggest superior ability. Conversely, a score around 85 suggests below-average fluid cognitive ability, and a score in the range of 70 or below suggests significant impairment."|Randomization (0 weeks), 4 weeks||||score on a scale||Standard Deviation|Mean
2533289|NCT03272139|Secondary|Block Duration|Length of nerve block reported by Phone call on POD 1 and POD 2 by patient phone call|Time of block wearing off recorded on Post Operative Day 1 and Post Operative Day 2 as reported via patient phone call.||||Hours||Inter-Quartile Range|Median
2533290|NCT03272139|Primary|Numerical Pain Rating System (NRS) Pain Scores|"Numerical Pain Rating System Pain scores after the superior trunk block and interscalene block at rest measured after the surgery every 30 minute until discharge according to the Post Anaesthetic Discharge Scoring System.~Numerical Rating Scale 0-10; with 0 being no pain and 10 pain as bad as you can imagine."|Average pain scores at rest recorded Day of Surgery every 30 minutes until discharge according to Post Anaesthetic Discharge Scoring System||||units on a scale 0-10||Inter-Quartile Range|Median
2533291|NCT03272139|Primary|Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP)|Our primary outcome will be the incidence of hemidiaphragmatic paralysis (HDP) with superior trunk block and interscalene blocks as measured by ultrasound before and after the surgery.|Day of Surgery, diagnosis confirmed from trained anesthesiologist ultrasound readers||||participants|||Number
2533292|NCT03271424|Primary|Quantitative Summaries of Participants Experience in Observation Sessions|Frequency counts of clarity of instructions, comfort using the test, confidence in test result, difficulty performing the test and reading results|12 month post study start||||Participants|||Count of Participants
2533294|NCT03271021|Secondary|IGA Treatment Success (Dichotomized as Yes/no) at Week 9, Where Success is Defined as an IGA Score of 0 or 1, and at Least a 2-grade Improvement (Decrease) From Baseline at the Interim Visit at Week 9||9 weeks||||participants|||Number
2533302|NCT03270657|Secondary|Number of Participants With Recorded DBS Local Evoked Potentials (DLEPs).|Measured by the ability to record DLEPs (changes in local electric field in response to DBS stimulation) through DBS electrodes using circuitry developed at Duke for this purpose and/or a new implantable pulse generator (IPG; RC+S) developed by Medtronic. These intraoperative studies will specifically test a preliminary version of the RC+S that is not designed for implantation. The DLEP recordings will be serially averaged with stimulus-triggering to remove random noise while preserving the evoked response.|End of procedure, approximately 45 minutes||||Participants|||Count of Participants
2533303|NCT03270657|Primary|Number of Participants With Recorded Evoked Neural Signals From Deep Brain Stimulation (DBS) Electrodes During DBS for Parkinson's Disease.|Measured by the ability to record neural activity through DBS electrodes using circuitry developed at Duke for this purpose and/or a new implantable pulse generator (IPG; RC+S) developed by Medtronic. These intraoperative studies will specifically test a preliminary version of the RC+S that is not designed for implantation.|End of procedure, approximately 45 minutes||||Participants|||Count of Participants
2533304|NCT03270644|Secondary|Change From Baseline (Day 8) in Diastolic Blood Pressure Following Propranolol Administered Alone and When Coadministered With Lasmiditan|Change from baseline in diastolic blood pressure was measured in supine position.|Baseline (Day 8), Day 9|All participants who had at least one dose of study drug and had evaluable baseline and post-baseline cardiovascular measurements.|||mmHg||Standard Deviation|Mean
2533305|NCT03270644|Secondary|Change From Baseline (Day 8) in Systolic Blood Pressure Following Propranolol Administered Alone and When Coadministered With Lasmiditan|Change from baseline in systolic blood pressure was measured in supine position.|Baseline (Day 8), Day 9|All participants who had at least one dose of study drug and had evaluable baseline and post-baseline cardiovascular measurements.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2533306|NCT03270644|Secondary|Change From Baseline (Day 8) in PR Interval Following Propranolol Administered Alone and When Coadministered With Lasmiditan|Change from baseline in PR interval, the interval between the P wave and the QRS complex calculated from electrocardiogram (ECG) data.|Baseline (Day 8), Day 9|All participants who had at least one dose of study drug and had evaluable baseline and post-baseline cardiovascular measurements.|||millisecond (msec)||Standard Deviation|Mean
2533307|NCT03270644|Secondary|Pharmacokinetic: Area Under the Concentration Versus Time Curve (AUC) of Propranolol During One Dosing Interval Alone and When Administered With Lasmiditan|AUC versus time curve of propranolol during one dosing interval when administered alone on Day 8 and when administered with lasmiditan on Day 9.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose|All participants who received at least one dose of study drug and have evaluable PK data.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2533308|NCT03270644|Secondary|Pharmacokinetic: Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Last Measurable Concentration [AUC(0-tlast)] of Lasmiditan Alone and When Administered With Propranolol|AUC versus time curve (AUC 0-tlast) of lasmiditan when administered alone on Day 1 and when coadministered with propranolol on Day 9.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose.|All participants who received at least one dose of study drug and have evaluable PK data.|||nanograms * hour/mL (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2533309|NCT03270644|Secondary|Pharmacokinetic: Maximum Observed Drug Concentration (Cmax) of Propranolol Alone and When Coadministered With Lasmiditan|Maximum concentration of propranolol when administered alone on Day 8 and when coadministered with lasmiditan on Day 9.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post-dose|All participants who received at least one dose of study drug and have evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2533310|NCT03270644|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan Alone and When Coadministered With Propranolol|Maximum concentration of lasmiditan when administered alone on Day 1 and when coadministered with propranolol on Day 9.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose.|All participants who received at least one dose of study drug and have evaluable PK data.|||nanogram per mililiter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2533311|NCT03270644|Primary|Change From Baseline (Day 8) in Mean Hourly Heart Rate Following Propranolol Administered Alone and When Coadministered With Lasmiditan|Change from baseline in mean hourly heart rate recorded as beats per minute and collected by Holter ambulatory monitoring in response to propranolol administered alone and in combination with lasmiditan.|Baseline (Day 8), Day 9|All participants who had at least one dose of study drug and had baseline and post-baseline cardiovascular measurements.|||beats per minute (bpm)||Standard Deviation|Mean
2533312|NCT03270085|Secondary|Number of Stools Per Day|The total number of bowel movements as reported by the participant via daily bowel diaries. The number of bowel movements were averaged for the 28 day treatment period.|Treatment days 1 through 28||||number of stools per day||Inter-Quartile Range|Median
2533313|NCT03270085|Primary|Stool Consistency|Stool consistency as reported by the participant via daily bowel diaries. Stool consistency was based on Bristol Stool Form Scale (BSFS) where 1 - hard lumps, 2 - lumpy sausage, 3 - cracked sausage, 4 - smooth sausage, 5 - soft lumps, 6 - mushy, and 7 - watery. Stool consistency was averaged for the 28 day treatment period.|Treatment days 1 through 28||||units on a scale||Inter-Quartile Range|Median
2533314|NCT03270085|Primary|Total Fecal Bile Acid (BA) Excretion|Total fecal BA excretion was measured using High Performance Liquid Chromatography (HPLC)/tandem mass spectrometry (MS) where single stool samples obtained at baseline and end of treatment were prepared by assay by HPLC/MS by methanol extraction and results are presented as micromoles per gram (μmoles/g) of stool.|Treatment day 28||||μmoles/g||Inter-Quartile Range|Median
2533315|NCT03269552|Secondary|Time to Progression|Estimated using Kaplan-Meier analysis.|Up to 1 year||||Months||Standard Error|Median
2533316|NCT03269552|Secondary|Time to Best Response|Estimated using Kaplan-Meier analysis.|Up to 1 year||||Months||Full Range|Median
2533317|NCT03269552|Secondary|Overall Survival|Estimated using Kaplan-Meier analysis.|Up to 1 year||||Participants|||Count of Participants
2533318|NCT03269552|Primary|Overall Response Rate|Descriptive statistics will be used for baseline characteristics, and responses to treatment.|Up to 1 year|Participants who were evaluated after cycle 2 day 15 and prior to cycle 3 day 1.|||Participants|||Count of Participants
2533319|NCT03268941|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 in Part 1||Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdose|PK set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of Tmax. Number analyzed are participants with evaluable data at given time-point.|||hour (hr)||Full Range|Median
2533320|NCT03268941|Secondary|Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-906 in Part 1||Part 1: Predose on Days 2, 3, 4, 5, 6, 7, 8 and 9|PK set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of Ctrough. Number analyzed are participants with evaluable data at given time-point.|||ng/mL||Standard Deviation|Mean
2533321|NCT03268941|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK 906 in Part 1||Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdose|PK set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of Cmax. Number analyzed are participants with evaluable data at given time-point.|||ng/mL||Standard Deviation|Mean
2533322|NCT03268941|Secondary|AUCτ: Area Under the Plasma Concentration-time Curve From 0 to Time (T) Over the Dosing Interval for TAK-906 in Part 1||Part 1: Day 1 predose and at multiple timepoints, (Up to 8 hours) postdose and Day 7 predose and at multiple timepoints (Up to 48 hours) postdose|Pharmacokinetic (PK) set included participants who were randomized and received at least 1 dose of study drug and had at least 1 measurable plasma TAK-906 concentration. Overall number of participants analyzed are participants with data available for analysis of AUCt. Number analyzed are participants with evaluable data at given time-point.|||h*ng/mL||Standard Deviation|Mean
2533323|NCT03268941|Secondary|Percent Change From Baseline in Gastric Emptying (GE) Time as Measured by the SmartPill on Day 7 for Part 1|SmartPill is an ingestible capsule that measures pressure, potential of hydrogen (pH) and temperature as it travels through the gastrointestinal (GI) tract to assess GE and GI motility. SmartPill eliminates radiation exposure and is the only motility test that provides a complete transit profile of the GI tract.|Baseline and Day 7|FAS included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline value, and had at least 1 valid postbaseline value for assessment of at least one of the PD measurements. Overall number of participants analyzed is number of participants with evaluable data for this outcome measure.|||percent change in GE time||Standard Deviation|Mean
2533324|NCT03268941|Secondary|Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time Following Single Dose Administration of TAK-906 Maleate as Measured by the 13C Spirulina GEBT on Day 1|The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE) in adults. The GEBT measures how fast solid food moves from the stomach to the small intestine during the digestive process and aids in the diagnosis of delayed stomach emptying (GP). GE half-emptying time is the time in minutes (min) for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT.|Baseline and Day 1 of Part 1|FAS included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline at least 1 valid postbaseline value for assessment of at least one PD measurement. Overall number of participants analyzed are participants with evaluable data for this outcome measure.|||minute (min)||Standard Deviation|Mean
2533325|NCT03268941|Secondary|Change From Baseline in Gastric Emptying Breath Test (GEBT) Gastric Half-emptying Time as Measured by the 13C Spirulina GEBT Following Multiple Dose Administration of TAK-906 Maleate on Day 7 for Part 1|The GEBT is a nonradioactive, noninvasive, orally administered test for measuring the rate of solid phase gastric emptying (GE) in adults. The GEBT measures how fast solid food moves from the stomach to the small intestine during the digestive process and aids in the diagnosis of delayed stomach emptying (GP). GE half-emptying time is the time in minutes (min) for half of the ingested solids to leave the stomach. This value was measured by the 13C spirulina GEBT.|Baseline and Day 7|FAS included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline value, and had at least 1 valid postbaseline value for assessment of at least one of the PD measurement. Overall number of participants analyzed are the participants with evaluable data for this outcome measure.|||min||Standard Deviation|Mean
2533326|NCT03268941|Secondary|Change From Baseline in Serum Prolactin Concentration on Day 1 at Tmax, Time of First Occurrence of Maximum Serum Concentration (Cmax) for TAK-906 Maleate for Part 1|Change in serum prolactin on Day 1 at the Tmax, time of first occurrence of maximum serum concentration (Cmax) relative to Baseline was calculated as a ratio of maximum serum prolactin concentration on Day 1 to serum prolactin concentration at Baseline.|Day 1 predose (Baseline), 1 hour and at multiple timepoints (Up to 8 hours) postdose|Full analysis set (FAS) included all participants who were randomized (Part 1), received at least 1 dose of study drug, had a baseline value, and had at least 1 valid postbaseline value for at least one of pharmacodynamic (PD) measurement. Overall number of participants analyzed are participants with evaluable data for this outcome measure.|||ratio||Standard Deviation|Mean
2533327|NCT03268941|Primary|Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Values|The 12-lead electrocardiogram (ECG) values outside the range Heart Rate <50 (beats/min), PR Interval ≤120 (msec), PR Interval ≥200 (msec), QRS Duration ≥120 (msec), QT Interval ≥460 (msec) were considered markedly abnormal.|From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)|SAS included all participants who were randomized (Part 1) or enrolled (Part 2) and received at least 1 dose of study drug in the respective part.|||Participants|||Count of Participants
2533328|NCT03268941|Primary|Number of Participants With Markedly Abnormal Vital Signs|Vital signs included body temperature, diastolic and systolic blood pressure (mmHg), and heart rate (beats per minute [bpm]). Heart rate<50 bpm and systolic blood pressure <85 mmHg were considered markedly abnormal.|From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)|SAS included all participants who were randomized (Part 1) or enrolled (Part 2) and received at least 1 dose of study drug in the respective part.|||Participants|||Count of Participants
2533329|NCT03268941|Primary|Number of Participants With Markedly Abnormal Laboratory Parameters Values|Clinical Laboratory parameters included tests for chemistry, hematology and urinalysis. Markedly abnormal values during treatment period were categorized as:alanine aminotransferase (ALT)>3.0 U/L*upper limit of normal(ULN),albumin<25 g/L*lower limit of normal(LLN),alkaline phosphatase >3.0 U/L*ULN,aspartate aminotransferase >3.0 U/L*ULN,bilirubin >2 umol/L*ULN,blood urea nitrogen(BUN) >10.7 mmol/L,calcium <1.75 mmol/L, >2.88 mmol/L,chloride <75 mmol/L, >126 mmol/L,creatinine >177umol/L,gamma glutamyl transferase (GGT) >3 U/L*ULN,glucose <2.8 mmol/L, >19.4 mmol/L,phosphate <0.52 mmol/L, >2.10 mmol/L,potassium<3 mmol/L, >6 mmol/L,sodium <130 mmol/L, >150 mmol/L,hematocrit (%) <0.8*LLN, >1.2*ULN,hemoglobin <0.8 g/L*LLN, >1.2 g/L*ULN,leukocytes <0.5 (10^9/L)*LLN, >1.5 (10^9/L)*ULN,erythrocytes<0.8 (10^12/L)*LLN, >1.2(10^12/L)*ULN,platelets <75(10^9/L), >600(10^9/L). Participants with at least 1 markedly abnormal laboratory parameter value is reported.|From Baseline to 14 days after the last dose of study drug in Part 1 (Up to approximately 23 days)|SAS included all participants who were randomized and received at least 1 dose of study drug in the Part 1. Laboratory assessment were performed only in Part 1 of the study. Number analyzed are participants with data available for the particular parameter.|||Participants|||Count of Participants
2533330|NCT03268941|Primary|Number of Participants Who Experienced At Least One or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any following reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|From Baseline to 14 days after the last dose of study drug (Up to approximately 39 days)|SAS included all participants who were randomized (Part 1) or enrolled (Part 2) and received at least 1 dose of study drug in the respective part.|||Participants|||Count of Participants
2533331|NCT03268746|Secondary|Percentage of Subjects Who Responded to Subjective Symptoms Questions (SSQs)|Subjects responded to 12 SSQs based on their experience during past 7 days for quality of vision and any change since cataract surgery as follows; Q1:How satisfied are you with your vision for seeing objects at near distance(ND)? Q2:How often do you wear eyeglasses or contact lenses for seeing objects at ND? Q3:How satisfied are you with your vision for seeing objects at intermediate distance(ID)? Q4:How often do you wear eyeglasses or contact lens for seeing objects at ID? Q5:How satisfied are you with your vision for seeing objects at distance(D)? Q6:How often do you wear eyeglasses or contact lens for seeing objects at D? Q7:How often do you experience halos? Q8:How severe were these halos? Q9:If you CURRENTLY DRIVE: how much difficulty do you have driving at night? Q10:If you DO NOT DRIVE at night, what is the reason? Q11:How satisfied are you with your cataract surgery result? Q12:Would you recommend cataract surgery and new lenses that were put into your eyes to other people?|Preoperative and Month 3 (Day 90-120 post second eye implantation)|Full Analysis Set (FAS)|||percentage of subjects|||Number
2533332|NCT03268746|Secondary|Binocular Photopic Best Corrected Contrast Sensitivity Without Glare|Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed binocularly under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, 12, and 18 cpd using the Vector Vision CSV 1000-HGT without a glare source. A higher numeric value will represent better contrast sensitivity. No formal statistical hypothesis testing was planned.|Month 3 (Day 90-120 post second eye implantation)|Full Analysis Set|||log unit||Standard Deviation|Mean
2533333|NCT03268746|Secondary|Binocular Photopic Best Corrected Contrast Sensitivity With Glare|Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed binocularly under photopic conditions at a distance of 8 feet from the eye at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000-HGT with a glare source. A higher numeric value will represent better contrast sensitivity. No formal statistical hypothesis testing was planned.|Month 3 (Day 90-120 post second eye implantation)|Full Analysis Set|||log unit||Standard Deviation|Mean
2533334|NCT03268746|Secondary|Binocular Uncorrected Near Visual Acuity (UCNVA) (40 cm)|VA was tested binocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 40 cm from the eye, representative of near distances for visual tasks. UCNVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.|Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)|Full Analysis Set|||logMAR||Standard Deviation|Mean
2533335|NCT03268746|Secondary|Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60 cm)|VA was tested binocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 60 cm from the eye, representative of intermediate distances for visual tasks. UCIVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.|Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)|Full Analysis Set|||logMAR||Standard Deviation|Mean
2533336|NCT03268746|Secondary|Binocular Uncorrected Distance Visual Acuity (UCDVA) (4 m)|VA was tested binocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 4 m from the eye, corresponding to a far distance for visual tasks. UCDVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.|Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)|Full Analysis Set. Number analyzed is the number of subjects with data available for analysis at specified time point.|||logMAR||Standard Deviation|Mean
2533454|NCT03267212|Secondary|Change in Cardiac Output During FES-row Testing|Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV|Day 0 and Day 2|Due to technical issues, only one participant could perform both tests (NIV and sham) for this outcome|||L/min|||Number
2533337|NCT03268746|Secondary|Monocular Uncorrected Near Visual Acuity (UCNVA) (40 cm)|VA was tested monocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 40 cm from the eye, representative of near distances for visual tasks. UCNVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. Both eyes contributed to the analysis. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.|Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)|All-implanted Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at specified time point.|||logMAR|Eyes|Standard Deviation|Mean
2533338|NCT03268746|Secondary|Monocular Uncorrected Intermediate Visual Acuity (UCIVA) [60 Centimeters (cm)]|VA was tested monocularly under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 60 cm from the eye, representative of intermediate distances for visual tasks. UCIVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. Both eyes contributed to the analysis. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.|Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)|All-implanted Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at specified time point.|||logMAR|Eyes|Standard Deviation|Mean
2533339|NCT03268746|Secondary|Monocular Uncorrected Distance Visual Acuity (UCDVA) (4 m)|VA was tested monocularly (each eye separately) under photopic conditions without visual correction using 100% contrast ETDRS charts at a distance of 4 m from the eye, corresponding to a far distance for visual tasks. UCDVA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. Both eyes contributed to the analysis. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.|Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)|This analysis population included all subjects with successful implantation of the test product in at least one eye (All-implanted Analysis Set). Number analyzed is the number of subjects/eyes with data available for analysis at specified time point.|||logMAR|Eyes|Standard Deviation|Mean
2533340|NCT03268746|Secondary|Binocular Best Corrected Distance Visual Acuity (BCDVA) [4 Meters (m)]|VA was tested binocularly under photopic conditions using the correction obtained from the manual manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters from the spectacle plane. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. No formal statistical hypothesis testing was planned.|Month 1 (Day 30-60 post second eye implantation) and Month 3 (Day 90-120 post second eye implantation)|Full Analysis Set. Number analyzed is the number of subjects with data available for analysis at specified time point.|||logMAR||Standard Deviation|Mean
2533341|NCT03268746|Secondary|Binocular Defocus Curve at Month 1|The defocus curve (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best distance correction across full range varied from +2.0 diopter (D) to -5.0 D in 0.5 D increments. VA at each spherical power was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better VA. No formal statistical hypothesis testing was planned.|Month 1 (Day 30-60 post second eye implantation)|Full Analysis Set. Number analyzed is the number of subjects with data available for analysis at specified defocus.|||logMAR||Standard Deviation|Mean
2533342|NCT03268746|Primary|Binocular Defocus Curve at Month 3|The defocus curve (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best distance correction across full range varied from +2.0 diopter (D) to -5.0 D in 0.5 D increments. The visual acuity (VA) at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better VA. No formal statistical hypothesis testing was planned.|Month 3 (Day 90-120 post second eye implantation)|This analysis population included all subjects with successful bilateral IOL implantation (Full Analysis Set). Number analyzed is the number of subjects with data available for analysis at specified defocus.|||logMAR||Standard Deviation|Mean
2533343|NCT03268590|Secondary|Cognitive Performance|Change in cognitive performance from Baseline Room Air breathing (21% inspired oxygen) to Pure Oxygen breathing (100% inspired oxygen). Measured using the General Cognitive Function score on the MicroCog^TM Assessment of Cognitive Functioning (TM= trademark of Pearson Education, Inc., New York, NY). The computer-administered MicroCog measures changes in cognitive performance in 9 domains related to attention, memory, reasoning, spatial processing, and reaction time. The General Cognitive Function score is a summed score and measures accuracy and speed processing. Education-adjusted Standardized Scores used to compare each study participant against population norms. Higher scores are indicative of better performance. Index Standardized Scores of 69 and below are considered Below Average; scores of 70-84 are considered Low Average; scores of 85-114 are considered to be Average; and scores of 115 and above are considered to be Above Average.|Baseline and at 30 minutes||||score on a scale||Standard Error|Mean
2533344|NCT03268590|Secondary|Cortical Network Activity|Change in alpha cortical electrical activity in the temporal brain region from Baseline Room Air breathing (21% inspired oxygen) to Pure Oxygen breathing (100% inspired oxygen). Measured using MRI-compatible 64-electrode high-density electroencephalography (EEG).|Baseline and at 30 minutes|Participants with usable MRI ASL (arterial spin labeling) data|||microvolt/second||Standard Error|Mean
2533345|NCT03268590|Primary|Cerebral Blood Flow|Change in brain blood flow from Baseline Room Air breathing (21% inspired oxygen) to Pure Oxygen breathing (100% inspired oxygen). Measured using Magnetic Resonance Imaging (MRI).|Baseline and at 30 minutes|Participants with usable MRI arterial spin labeling (ASL) data|||ml/min/100g tissue||Standard Deviation|Mean
2533356|NCT03268005|Secondary|Change From Baseline in Body Mass Index (BMI)|Change in the body mass index (BMI) from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||kg/m^2||Standard Deviation|Mean
2533346|NCT03268343|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to AEs, by Severity and Relationship|An adverse event (AE) is defined as any untoward medical occurrence which does not necessarily have a causal relationship with the treatment. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of study drug that worsen after the subject receives the first dose of study drug. A serious adverse event (SAE) is defined as an AE that: results in death; is life-threatening; requires hospitalization or prolongs existing inpatient's hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medical event which requires medical intervention to prevent any of the above outcomes. Event severity was categorized as mild, moderate, or severe. Relationship of event to study drug was categorized as definite, probably, possible, unlikely, not related, or not applicable (N/A).|Day -1 to Day 7 plus 6-8 days (post-study follow-up)|Safety Analysis Set: all participants who received at least one dose of cytisine.|||participants|||Number
2533347|NCT03268343|Secondary|Urine Cytisine PK: Percentage of Drug Excreted in Urine (Ae%)|To assess the renal elimination of cytisine via measurement of urinary concentrations of cytisine.|Pre-dose (within 30 minutes prior to first dose); 0-2 hours, 2-4 hours, 4-8 hours, 8-12 hours and 12-24 hours post-dose|PK Set: All participants who received doses under both fed and fasted conditions and did not have an occurrence of vomiting which rendered the concentration profile unreliable. (Two participants were excluded for vomiting before twice the median Tmax had been reached following 3 mg cytisine administered in a fed state.)|||percentage of drug excreted||Standard Deviation|Mean
2533348|NCT03268343|Secondary|Urine Cytisine PK: Amount Excreted in Urine Over Time (Ae)||Pre-dose (within 30 minutes prior to first dose); 0-2 hours, 2-4 hours, 4-8 hours, 8-12 hours and 12-24 hours post-dose|PK Set: All participants who received doses under both fed and fasted conditions and did not have an occurrence of vomiting which rendered the concentration profile unreliable. (Two participants were excluded for vomiting before twice the median Tmax had been reached following 3 mg cytisine administered in a fed state.)|||mg||Standard Deviation|Mean
2533349|NCT03268343|Secondary|Plasma Cytisine PK: Apparent Terminal Elimination Half-Life (t1/2)||Pre-dose (within 60 minutes of dosing); 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 16 hours and 24 hours post-dose (+/- 1 minute)|PK Set: All participants who received doses under both fed and fasted conditions and did not have an occurrence of vomiting which rendered the concentration profile unreliable. (Two participants were excluded for vomiting before twice the median Tmax had been reached following 3 mg cytisine administered in a fed state.)|||hours||Standard Deviation|Mean
2533350|NCT03268343|Secondary|Plasma Cytisine PK: Apparent Terminal Elimination Rate Constant (Lambda z)||Pre-dose (within 60 minutes of dosing); 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 16 hours and 24 hours post-dose (+/- 1 minute)|PK Set: All participants who received doses under both fed and fasted conditions and did not have an occurrence of vomiting which rendered the concentration profile unreliable. (Two participants were excluded for vomiting before twice the median Tmax had been reached following 3 mg cytisine administered in a fed state.)|||1/hour||Standard Deviation|Mean
2533351|NCT03268343|Secondary|Plasma Cytisine PK: Residual Area, or Percentage of Extrapolated Part for the Calculation of AUC0-∞ (AUC%)||Pre-dose (within 60 minutes of dosing); 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 16 hours and 24 hours post-dose (+/- 1 minute)|PK Set: All participants who received doses under both fed and fasted conditions and did not have an occurrence of vomiting which rendered the concentration profile unreliable. (Two participants were excluded for vomiting before twice the median Tmax had been reached following 3 mg cytisine administered in a fed state.)|||percentage of extrapolated part||Standard Deviation|Mean
2533352|NCT03268343|Secondary|Plasma Cytisine PK: AUC From Time Zero to the Last Sampling Time (AUC0-t)||Pre-dose (within 60 minutes of dosing); 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 16 hours and 24 hours post-dose (+/- 1 minute)|PK Set: All participants who received doses under both fed and fasted conditions and did not have an occurrence of vomiting which rendered the concentration profile unreliable. (Two participants were excluded for vomiting before twice the median Tmax had been reached following 3 mg cytisine administered in a fed state.)|||h*ng/mL||Standard Deviation|Mean
2533353|NCT03268343|Secondary|Plasma Cytisine PK: Time of Occurrence of Cmax (Tmax)||Pre-dose (within 60 minutes of dosing); 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 16 hours and 24 hours post-dose (+/- 1 minute)|PK Set: All participants who received doses under both fed and fasted conditions and did not have an occurrence of vomiting which rendered the concentration profile unreliable. (Two participants were excluded for vomiting before twice the median Tmax had been reached following 3 mg cytisine administered in a fed state.)|||hours||Full Range|Median
2533354|NCT03268343|Primary|Plasma Cytisine PK: Total Area Under the Curve From Time Zero to Infinity (AUC0-∞)||Pre-dose (within 60 minutes of dosing); 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 16 hours and 24 hours post-dose (+/- 1 minute)|PK Set: All participants who received doses under both fed and fasted conditions and did not have an occurrence of vomiting which rendered the concentration profile unreliable. (Two participants were excluded for vomiting before twice the median Tmax had been reached following 3 mg cytisine administered in a fed state.)|||h*ng/mL||Standard Deviation|Mean
2533355|NCT03268343|Primary|Plasma Cytisine Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)||Pre-dose (within 60 minutes of dosing); 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 16 hours and 24 hours post-dose (+/- 1 minute)|PK Set: All participants who received doses under both fed and fasted conditions and did not have an occurrence of vomiting which rendered the concentration profile unreliable. (Two participants were excluded for vomiting before twice the median Tmax had been reached following 3 mg cytisine administered in a fed state.)|||ng/mL||Standard Deviation|Mean
2539138|NCT03079375|Secondary|Drug-related Admissions|number of patients who have drug related admissions|180 days after the inclusion date||||Participants|||Count of Participants
2533357|NCT03268005|Secondary|Change From Baseline in Body Weight|Changes in body weight from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||kg||Standard Deviation|Mean
2533358|NCT03268005|Secondary|Change From Baseline in Biochemistry - Total Protein|Changes in biochemistry - total protein from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||g/dL||Standard Deviation|Mean
2533359|NCT03268005|Secondary|Change From Baseline in Biochemistry - Total Bilirubin|Changes in biochemistry - total bilirubin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||umol/L||Standard Deviation|Mean
2533360|NCT03268005|Secondary|Change From Baseline in Biochemistry - Sodium|Changes in biochemistry - sodium from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2533361|NCT03268005|Secondary|Change From Baseline in Biochemistry - Potassium|Changes in biochemistry - potassium from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2533362|NCT03268005|Secondary|Change From Baseline in Biochemistry - Creatinine|Changes in biochemistry - creatinine from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||umol/L||Standard Deviation|Mean
2533363|NCT03268005|Secondary|Change From Baseline in Biochemistry - Albumin|Changes in biochemistry - albumin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||g/dL||Standard Deviation|Mean
2533364|NCT03268005|Secondary|Change From Baseline in Biochemistry - Aspartate Aminotransferase (AST)|Changes in biochemistry - aspratate aminotransferase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||U/L||Standard Deviation|Mean
2533365|NCT03268005|Secondary|Change From Baseline in Biochemistry - Alkaline Phosphatase|Changes in biochemistry - alkaline phosphatase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||U/L||Standard Deviation|Mean
2533366|NCT03268005|Secondary|Change From Baseline in Biochemistry - Alanine Aminotransferase (ALT)|Changes in biochemistry - alanine aminotransferase from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||U/L||Standard Deviation|Mean
2533367|NCT03268005|Secondary|Change From Baseline in Haematology - Erythrocytes|Changes in haematology - erythrocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||10^12 erythrocytes/L||Standard Deviation|Mean
2533368|NCT03268005|Secondary|Change From Baseline in Haematology - Thrombocytes|Changes in haematology - thrombocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||10^9 thrombocytes/L||Standard Deviation|Mean
2533369|NCT03268005|Secondary|Change From Baseline in Haematology - Leukocytes|Changes in haematology - leukocytes from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||10^9 leukocytes/L||Standard Deviation|Mean
2533370|NCT03268005|Secondary|Change From Baseline in Haematology - Haemoglobin|Changes in haematology - haemoglobin from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2533371|NCT03268005|Secondary|Change From Baseline in Haematology - Haematocrit|Changes in haematology - haematocrit from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||Percentage||Standard Deviation|Mean
2533372|NCT03268005|Secondary|Change From Baseline in Fundoscopy/Fundus Photography|Changes in fundoscopy/fundus photography from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2533373|NCT03268005|Secondary|Change From Baseline in Electrocardiogram (ECG)|Changes in electrocardiogram (ECG) from baseline (week 0) were evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2533374|NCT03268005|Secondary|Change From Baseline in Vital Signs: Pulse|Change in vital signs - pulse from baseline (week 0) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||Beats per min||Standard Deviation|Mean
2533375|NCT03268005|Secondary|Change From Baseline in Vital Signs: Systolic and Diastolic Blood Presure|Change in vital signs - systolic and diastolic blood pressure from baseline (week 0) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||mmHg||Standard Deviation|Mean
2533376|NCT03268005|Secondary|Change From Baseline in Physical Examination|Participants with physical examination findings, normal, abnormal NCS (non- clinically significant) and abnormal CS (clinically significant) at baseline (week 0) and week 16 presented. Results are based on the data from the on-treatment observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system 2) Central & Peripheral nervous system 3) Gastrointestinal system incl. mouth 4) Head, ears, eyes, nose, throat and neck 5) Musculoskeletal system 6) Respiratory system 7) Skin|Week 0, week 16|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2533377|NCT03268005|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal|Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 4 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Weeks 0-16|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Number of hypoglycaemic episodes|||Number
2533378|NCT03268005|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal|Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 4 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Weeks 0-16|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Number of hypoglycaemic episodes|||Number
2533455|NCT03267212|Primary|Change in Peak Aerobic Capacity During FES-row Testing|Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV|Day 0 and Day 2|10 subjects completed both NIV and Sham tests|||L/min||Standard Deviation|Mean
2533379|NCT03268005|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal|Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 2 hours after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Weeks 0-16|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Number of hypoglycaemic episodes|||Number
2533380|NCT03268005|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal|Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 1 hour after start of the meal. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Weeks 0-16|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Number of hypoglycaemic episodes|||Number
2533381|NCT03268005|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)|Number of treatment emergent nocturnal hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 00:01 and 05:59 (both included). The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Weeks 0-16|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Number of hypoglycaemic episodes|||Number
2533382|NCT03268005|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)|Number of treatment emergent day time hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 06:00 and 00:00 (both included). The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Weeks 0-16|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Number of hypoglycaemic episodes|||Number
2533383|NCT03268005|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall|"ADA classification of hypos:~Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.~Documented symptomatic: PG ≤3.9 mmol/L with symptoms.~Asymptomatic: PG ≤3.9 mmol/L without symptoms.~Probable symptomatic: No measurement with symptoms.~Pseudo: PG >3.9 mmol/L with symptoms.~Unclassifiable.~NN classification of hypos:~BG confirmed: PG <3.1 mmol/L with/without symptoms.~Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms.~Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms.~Unclassifiable. Not able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypoglycaemia."|Weeks 0-16|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Number of hypoglycaemic episodes|||Number
2533384|NCT03268005|Secondary|Number of Treatment Emergent Injection Site Reactions|Number of treatment emergent injection site reactions were recorded from week 0 to week 16. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Weeks 0-16|Overall number of participants analyzed = number of participants with available data.|||Number of injection site reactions|||Number
2533385|NCT03268005|Secondary|Number of Treatment Emergent Adverse Events|Number of treatment emergent adverse events were recorded from week 0 to week 16. The results are based on the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|Weeks 0-16|Overall number of participants analyzed = number of participants with available data.|||Events|||Number
2533386|NCT03268005|Secondary|Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline|Reported results are lipids-lipoproteins (total cholesterol, high density lipoproteins, low density lipoproteins) values are given as ratio to baseline (week 0) after 16 weeks. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.|Week 0, week 16|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2533387|NCT03268005|Secondary|Individual Meal Insulin Dose: in Units/kg|Individual meal time bolus insulin dose (Units/kg) for breakast, lunch and main evening meal was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|16 weeks from randomisation|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Units/kg||Standard Deviation|Mean
2533576|NCT03265132|Secondary|Proportion of Patients With Absence of Rash.|Absence of rash is evaluated 24 hours preceding Week 1 and 7 days preceding Week 2, Week 4, Week 8 and Week 12. Only data at Week 2 reported here.|Week 2||||Participants|||Count of Participants
2533388|NCT03268005|Secondary|Individual Meal Insulin Dose: in Units|Individual meal time bolus insulin dose (Units) for breakast, lunch and main evening meal was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|16 weeks from randomisation|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Units||Standard Deviation|Mean
2533389|NCT03268005|Secondary|Total Basal Insulin Dose: in Units/kg/Day|Total basal insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|16 weeks from randomisation|Overall number of participants analyzed = number of participants with available data.|||Units/kg/day||Standard Deviation|Mean
2533390|NCT03268005|Secondary|Total Basal Insulin Dose: in Units/Day|Total basal insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|16 weeks from randomisation|Overall number of participants analyzed = number of participants with available data.|||Units/day||Standard Deviation|Mean
2533391|NCT03268005|Secondary|Total Bolus Insulin Dose: in Units/kg/Day|Total bolus insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|16 weeks from randomisation|Overall number of participants analyzed = number of participants with available data.|||Units/kg/day||Standard Deviation|Mean
2533392|NCT03268005|Secondary|Total Bolus Insulin Dose: in Units/Day|Total bolus insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period started from date of first dose of randomised NovoRapid/faster aspart and to 7 days after day of last dose or day before initiation of ancillary treatment.|16 weeks from randomisation|Overall number of participants analyzed = number of participants with available data.|||Units/day||Standard Deviation|Mean
2533393|NCT03268005|Secondary|Participants Who Achieved Overall PPG <7.8 mmol/L (140 mg/dL) Without Severe Hypoglycaemia Episodes (Yes/No)|Participants reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] without severe hypoglycaemia episodes was evaluated after 16 weeks of randomisation. Participants without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.|16 weeks after randomisation|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2533394|NCT03268005|Secondary|Participants Who Achieved Overall PPG (1 Hour) <7.8 mmol/L (140 mg/dL) (Yes/No)|Participants reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] was evaluated after 16 weeks of randomisation. Participants without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.|16 weeks after randomisation|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2533395|NCT03268005|Secondary|Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements|Change from baseline (week 0) in nocturnal SMPG measurements was assessed by considering the differences between PG values available at bedtime, at 4 AM and the before breakfast value the following day: (4 AM PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 4 AM PG value). Change from baseline in nocturnal increments in SMPG measurements of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation and presented during three different time intervals as follows: 1) 04:00 to breakfast, 2) bedtime to 04:00, and 3) bedtime to breakfast. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.|Week 0, week 16|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2533396|NCT03268005|Secondary|Change From Baseline of the 7-9-7 Point SMPG Profile: Fluctuation in 7-9-7 Point Profile|Fluctuation in 7-point SMPG profile was the average absolute difference from the mean of the SMPG profile. Reported results are fluctuation in the 7-9-7 point SMPG profile from baseline (week 0) after 16 weeks of randomisation (i.e., week 16). The results are presented as ratio to baseline. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2533406|NCT03268005|Secondary|Change From Baseline in 1-hour PPG Increment|Change from baseline (week 0) in 1-hour postprandial glucose (PPG) increment was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2542681|NCT02994732|Primary|Pharmacokinetics of 14C-labeled BVD-523(Radioactivity in Whole Blood and Plasma) V/F|Apparent volume of distribution (V/F)|Collected over 15 days|All enrolled subjects|||L||Standard Deviation|Mean
2533397|NCT03268005|Secondary|Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)|Change from baseline (week 0) in PPG increment (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. PPG increment based on the 7-9-7-point profiles were derived separately for PG measurements made at 1 hour after main meals (breakfast, lunch and main evening meal). PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value. In trial observation period was from date of randomisation and until last trial-related participant-site contact.|Week 0, week 16|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2533398|NCT03268005|Secondary|Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)|Change from baseline (week 0) in PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.|Week 0, week 16|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2533399|NCT03268005|Secondary|Change From Baseline in Mean of the 7-9-7 Point Self-measured Plasma Glucose (SMPG) Profile|Change from baseline (week 0) in mean of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. 7-9-7 point SMPG was measured at the following mentioned time points: 1) Before breakfast, 2) 60 mins after the start of Breakfast, 3) Before lunch, 4) 60 mins after the start of lunch, 5) Before main evening meal, 6) 60 mins after the start of main evening meal, 7) At bedtime, 8) At 4 AM, 9) Before breakfast.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2533400|NCT03268005|Secondary|Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)|Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG increment (meal test) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal. PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value.|Week 0, week 16|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2533401|NCT03268005|Secondary|Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test])|Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour postprandial glucose (PPG [meal test]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.|Week 0, week 16|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2533402|NCT03268005|Secondary|Participants Who Achieved HbA1c <7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No)|Number of participants reaching HbA1c <7.0% (53 mmol/L) without severe hypoglycaemia episodes was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.|16 weeks after randomisation|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2533403|NCT03268005|Secondary|Participants Who Achieved HbA1c <7.0% (53 mmol/L) (Yes/No)|Number of participants reaching HbA1c <7.0% (53 mmol/L) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.|16 weeks after randomisation|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2533404|NCT03268005|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline (week 0) in fasting plasma glucose was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2533405|NCT03268005|Secondary|Change From Baseline in 1,5-anhydroglucitol|Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In trial observation period was from date of randomisation and until last trial-related participant-site contact.|Week 0, week 16|Overall number of participants analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2542682|NCT02994732|Primary|Pharmacokinetics of 14C-labeled BVD-523(Radioactivity in Whole Blood and Plasma) CL/F|Oral Clearance (CL/F)|Collected over 15 days|All enrolled subjects|||L/hr||Standard Deviation|Mean
2533408|NCT03267940|Secondary|Run-in and Expansion Portion: Area Under the Concentration Time Curve (AUC) of PEGPH20, ATEZO, GEM, and CIS|PK data were planned to be analyzed using a noncompartmental analysis approach.|PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9|Data for this outcome measure was not collected due to early termination of study.||||||
2533409|NCT03267940|Secondary|Run-in and Expansion Portion : Volume of Distribution (Vd) of PEGPH20, ATEZO, GEM, and CIS|PK data were planned to be analyzed using a noncompartmental analysis approach.|PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9|Data for this outcome measure was not collected due to early termination of study.||||||
2533410|NCT03267940|Secondary|Run-in and Expansion Portion : Clearance (CL) of PEGPH20, ATEZO, GEM, and CIS|PK data were planned to be analyzed using a noncompartmental analysis approach.|PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9|Data for this outcome measure was not collected due to early termination of study.||||||
2533411|NCT03267940|Secondary|Run-in and Expansion Portion : Terminal Elimination Plasma Half-life (t1/2) of PEGPH20, ATEZO, GEM, and CIS|PK data were planned to be analyzed using a noncompartmental analysis approach.|PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and EOT visit (maximum exposure: 508 days for run-in and 421 days for expansion portion); CIS and GEM: Cycle 1: multiple timepoints on Days 2, 9|Data for this outcome measure was not collected due to early termination of study.||||||
2533412|NCT03267940|Secondary|Run-in and Expansion Portion : Elimination Rate Constant (Kel) of PEGPH20|PK data were planned to be analyzed using a noncompartmental analysis approach.|Cycle 1: multiple timepoints on Days 1, 2, 8, 9, and 15|Data for this outcome measure was not collected due to early termination of study.||||||
2533413|NCT03267940|Secondary|Run-in and Expansion Portion : Minimum Observed Plasma Concentration (Cmin) of PEGPH20 and ATEZO|PK data were planned to be analyzed using a noncompartmental analysis approach.|PEGPH20 and ATEZO: Treatment Cycle 1: multiple timepoints on Days 1, 2, 8, 9, and 15; ATEZO: Day 1 of subsequent cycles and EOT visit (7 days after last 21-day cycle) (maximum exposure: 508 days for run-in portion and 421 days for expansion portion)|Data for this outcome measure was not collected due to early termination of study.||||||
2533414|NCT03267940|Secondary|Run-in and Expansion Portion : Maximum Observed Plasma Concentration (Cmax) of PEGPH20, ATEZO, GEM, and CIS|Plasma pharmacokinetic (PK) data were planned to be analyzed using a noncompartmental analysis approach.|PEGPH20 and ATEZO: Cycle 1: multiple timepoints on Days 1, 2, 8, 9, 15; ATEZO: Day 1 of subsequent cycles and end of treatment (EOT) (maximum exposure: 508 days for run-in and 421 days for expansion); CIS and GEM: Cycle 1: multiple timepoints on Days 2,9|Data for this outcome measure was not collected due to early termination of study.||||||
2533415|NCT03267940|Secondary|Expansion Period: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication|Number of participants with AEs leading to dose reduction or interruption of any study medication (PEGPH20, CIS, GEM, or ATEZO) was reported. An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.|From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 421 days)|Safety population included all participants who received any study medication.|||Participants|||Count of Participants
2533416|NCT03267940|Secondary|Expansion Portion: Number of Participants With Clinically Significant Abnormalities in ECG and Vital Signs|Clinical significance of ECGs was defined as per Investigator's discretion. Assessment of vital signs was to include the measurement of blood pressure (systolic and diastolic), pulse, respiratory rate, and body temperature. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.|From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)|Data for this outcome measure was not collected due to early termination of study.||||||
2533417|NCT03267940|Secondary|Expansion Portion: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters (Hematology and Blood Chemistry)|Laboratory parameters evaluation included hematology (hemoglobin, hematocrit, red blood cell count, WBC count, neutrophils [ANC], lymphocytes, monocytes, eosinophils, basophils, granulocytes, mean corpuscular hemoglobin, mean corpuscular volume, and platelet count) and blood chemistry (glucose, BUN, albumin, total bilirubin, alkaline phosphatase, AST, ALT, electrolytes [including sodium, potassium, calcium, magnesium, chloride, and bicarbonate], and creatinine) evaluation. Clinical significance was defined as per Investigator's discretion. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.|From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)|Safety population included all participants who received any study medication.|||Participants|||Count of Participants
2533418|NCT03267940|Secondary|Expansion Portion: Number of Participants With AEs|An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.|From first exposure to study drug through the end of treatment visit (maximum exposure: 421 days)|Safety population included all participants who received any study medication.|||Participants|||Count of Participants
2566941|NCT02573779|Primary|Weight Gain|Weight gain will be evaluated weekly throughout the study (defined as g/kg/day)|6-10 weeks||||g/kg/day||Standard Deviation|Mean
2533421|NCT03267940|Secondary|Expansion Portion: Disease Control Rate (DCR) Based on RECIST v1.1: Percentage of Participants With CR, PR or Stable Disease (SD)|DCR was defined as the percentage of participants with CR, PR, or SD based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.|From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days)|Data for this outcome measure was not collected due to early termination of study.||||||
2533422|NCT03267940|Secondary|Expansion Portion: Progression-Free Survival (PFS) Based on RECIST v1.1|PFS was based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review and was defined as the time from randomization to radiological disease progression or death. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on or prior to the current assessment (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of greater than or equal to (≥) 5 mm.|From date of randomization until date of progressive disease or death from any cause, whichever came first (maximum exposure: 421 days)|Data for this outcome measure was not collected due to early termination of study.||||||
2533423|NCT03267940|Secondary|Expansion Portion: Duration of Response (DOR) Based on RECIST v1.1|DOR was considered the time from date of the first CR or PR until the date of first documentation of disease progression or date of death based on RECIST v1.1 for target lesions assessed by MRI/CT scans, as determined by independent radiologic review. CR was defined as the disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.|From date of the first CR or PR until the date of first documentation of disease progression or date of death, whichever came first (maximum exposure: 421 days)|Data for this outcome measure was not collected due to early termination of study.||||||
2533424|NCT03267940|Secondary|Run-in Portion: ORR Based on RECIST v1.1: Percentage of Participants With Objective Response|ORR was defined as percentage of participants who achieved either a CR or PR. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|From date of randomization until the date of first documented progression of disease or date of death from any cause, whichever came first (maximum exposure: 508 days)|Data for this outcome measure was not Collected due to early termination of study.||||||
2533425|NCT03267940|Primary|Expansion Portion: Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1: Percentage of Participants With Objective Response|ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|From date of randomization until the date of first documented progression of disease or date of death from any cause, whichever came first (maximum exposure: 421 days)|Data for this outcome measure was not collected due to early termination of study.||||||
2533426|NCT03267940|Primary|Run-in Portion: Number of Participants With AEs Leading to Dose Reduction or Interruption of Any Study Medication|Number of participants with AEs leading to dose reduction or interruption of any study medication (PEGPH20, CIS, GEM, or ATEZO) was reported. An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.|From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)|Safety population included all participants who received any study medication.|||Participants|||Count of Participants
2533427|NCT03267940|Primary|Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) and Vital Signs|Clinical significance of ECGs was defined as per Investigator's discretion. Assessment of vital signs was to include the measurement of blood pressure (systolic and diastolic), pulse, respiratory rate, and body temperature. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.|From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)|Data for this outcome measure was not collected due to early termination of study.||||||
2533428|NCT03267940|Primary|Run-in Portion: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters (Hematology and Blood Chemistry)|Laboratory parameters evaluation included hematology (hemoglobin, hematocrit, red blood cell count, white blood cell [WBC] count, neutrophils [ANC], lymphocytes, monocytes, eosinophils, basophils, granulocytes, mean corpuscular hemoglobin, mean corpuscular volume, and platelet count) and blood chemistry (glucose, blood urea nitrogen [BUN], albumin, total bilirubin, alkaline phosphatase, aspartate aminotransferase [AST], alanine aminotransferase [ALT], electrolytes [including sodium, potassium, calcium, magnesium, chloride, and bicarbonate], and creatinine) evaluation. Clinical significance was defined as per Investigator's discretion. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.|From first exposure to study drug through the end of treatment visit (maximum exposure: 508 days)|Safety population included all participants who received any study medication.|||Participants|||Count of Participants
2533536|NCT03266172|Primary|AUC(0-inf) of GSK2982772 in MT Formulation :Part A|Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf).|Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose|PK Population. Only those participants with data available at specified time frame were analyzed.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533429|NCT03267940|Primary|Run-in Portion: Number of Participants With Adverse Events (AEs)|An AE is any unfavorable or unintended sign, symptom, or disease temporally associated with the use of a pharmaceutical product (for example, study drug), whether or not considered related to the pharmaceutical product. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.|From first exposure to study drug through 30 days after the end of treatment visit (maximum exposure: 508 days)|Safety population included all participants who received any study medication.|||Participants|||Count of Participants
2533430|NCT03267576|Secondary|Change From Baseline in Percentage of 2 Consecutive Glucose Readings With < 70 mg/dL|The percentage of 2 consecutive glucose readings with < 70 mg/dL were reported. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.|Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.|||Percentage of readings||Standard Deviation|Mean
2533431|NCT03267576|Secondary|Change From Baseline in Time Spent With Glucose Level < 70 mg/dL|Time spent with the glucose level < 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.|Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.|||Minutes||Standard Deviation|Mean
2533432|NCT03267576|Secondary|Change From Baseline in Time Spent With Glucose Level > 180 mg/dL|Time spent with the glucose level > 180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure.|Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.|||Minutes||Standard Deviation|Mean
2533433|NCT03267576|Secondary|Change From Baseline in Time Spent With Glucose Level > 140 mg/dL|Time spent with the glucose level > 140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.|Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.|||Minutes||Standard Deviation|Mean
2533434|NCT03267576|Secondary|Change From Baseline in Time Spent With Glucose Level 70 to 139 mg/dL|Time spent with the glucose level 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.|Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.|||Minutes||Standard Deviation|Mean
2533435|NCT03267576|Secondary|Percent Change From Baseline in Time During 24 Hours With Glucose Level Less Than (<) 70 mg/dL|Percent change from baseline in time during 24 hours within the glucose levels < 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.|Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.|||Percent Change||Standard Deviation|Mean
2533436|NCT03267576|Secondary|Percent Change From Baseline in Time During 24 Hours With Glucose Level > 180 mg/dL|Percent change from baseline in time during 24 hours within the glucose levels >180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure.|Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.|||Percent Change||Standard Deviation|Mean
2533456|NCT03266419|Secondary|Mean Visual Analogue Scale (VAS) Score for Wound Pain at Post Anesthesia Care Unit (PACU)|The patient was administered intravenous oxycodone 2 mg (body weight <80 kg) or 3 mg (>80 kg) every 10 min until the visual analogue scale (VAS) assessments showed that the pain intensity had decreased to <3 at rest and <5 on wound compression. At this point, the minimum effective analgesic dose (MEAD) of oxycodone was determined. The range of VAS is 0-10 (0 = no pain; 10 = most severe pain).|Through study period in post anesthesia care unit (PACU), an average of about 1 hour|patients undergoing elective laparoscopic gastrectomy|||mm||Full Range|Mean
2533437|NCT03267576|Secondary|Percent Change From Baseline in Time During 24 Hours With Glucose Greater Than (>) 140 mg/dL|Percent change from baseline in time during 24 hours within the glucose levels >140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.|Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.|||Percent Change||Standard Deviation|Mean
2533438|NCT03267576|Secondary|Percent Change From Baseline in Time During 24 Hours With Glucose 70 to 139 mg/dL|Percent change from baseline in time during 24 hours with glucose levels 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.|Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|PP analysis set included all intent-to-treat participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.|||Percent Change||Standard Deviation|Mean
2533439|NCT03267576|Secondary|Change From Baseline in 2-hour Post-prandial Glucose (PPG) Levels|2-hour post-prandial glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.|Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.|||mg/dL||Standard Deviation|Mean
2533440|NCT03267576|Secondary|Change From Baseline in Fasting Plasma Glucose Levels|Fasting plasma glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.|Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.|||mg/dL||Standard Deviation|Mean
2533441|NCT03267576|Secondary|Change From Baseline in Mean 24-hour Glucose Profile|Mean 24-hour glucose profiles as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.|Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.|||mg/dL||Standard Deviation|Mean
2533442|NCT03267576|Secondary|Change From Baseline in Glycemic Standard Deviation (SD) for 24-hour Glucose Profile|Glycemic standard deviation for 24-hour glucose profile (glycemic variability), as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants who received the study drug in the treatment period 1 and 2 as per the sequence were reported in this outcome measure.|Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)|Per-protocol (PP) analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful.|||mg/dL||Standard Deviation|Mean
2533443|NCT03267576|Primary|Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 2|Continuous blood glucose monitoring was done in participants using CGM determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.|Baseline up to End of Treatment Period 2 (Days 66 to 71)|ITT analysis set included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful (>70% of tracings available).|||Percentage of CV||Standard Deviation|Mean
2533444|NCT03267576|Primary|Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1|Continuous blood glucose monitoring was done in participants using continuous glucose monitoring (CGM) determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation (CV) was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.|Baseline up to End of Treatment Period 1 (Days 22 to 27)|Intent-to-treat (ITT) analysis set included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful (greater than [>] 70% of tracings available).|||Percentage of CV||Standard Deviation|Mean
2533473|NCT03266172|Secondary|Number of Participants Abnormal Urinalysis Dipstick Results: Part C|Urine samples were collected for analysis of specific gravity, potential of hydrogen ions, glucose, protein, blood and ketones by dipstick method. Microscopic examination were performed if blood or protein values were abnormal.|Up to Day 43|Safety Population|||Participants|||Count of Participants
2566942|NCT02573779|Primary|Hospital Length of Stay|Hospital length of stay will be calculated from birth to discharge of infant.|Birth to discharge||||days||Standard Deviation|Mean
2533445|NCT03267511|Secondary|Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 2 Versus vs. Reference Product 2)|An assessment of the area and intensity of dental stain on the study teeth will be performed using the MLSI after usage test product 2 and reference product 2 for 8 weeks, twice daily brushing. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI will be calculated by multiplying scores of intensity and area, and will be thus analyzed on a scale of 0 (best score) to 9 (worst score).|Baseline, Week 8 post treatment administration|The ITT population comprised all participants who were randomly allocated to treatment and received the study treatment at least once and provided at least 1 post-baseline (post-treatment) assessment of efficacy. This population was based on the randomized treatment to which the participant was allocated.|||Score on a scale||Standard Error|Least Squares Mean
2533446|NCT03267511|Secondary|Difference of Least Square Mean of Change From Baseline in Overall MLSI After 8 Weeks (Test Product 1 Versus vs. Reference Product 1)|An assessment of the area and intensity of dental stain on the study teeth will be performed using the MLSI after usage test product 1 and reference product 1 for 8 weeks, twice daily brushing. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI will be calculated by multiplying scores of intensity and area, and will be thus analyzed on a scale of 0 (best score) to 9 (worst score).|Baseline, Week 8 post treatment administration|The ITT population comprised all participants who were randomly allocated to treatment and received the study treatment at least once and provided at least 1 post-baseline (post-treatment) assessment of efficacy. This population was based on the randomized treatment to which the participant was allocated.|||Score on a scale||Standard Error|Least Squares Mean
2533447|NCT03267511|Primary|Change From Baseline in Overall Macpherson Modification of the Lobene Stain Index (MLSI) at 8 Weeks.|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI to evaluate ranking order in extrinsic dental stain removal or reduction of test product 1, test product 2, reference product 1, reference product 2; after usage for 8 weeks, twice daily brushing. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI was calculated by multiplying scores of intensity and area, and was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Baseline, Week 8 post treatment administration|The Intent-to-Treat (ITT) (n=123) population comprised all participants who were randomly allocated to treatment and received the study treatment at least once and provided at least 1 post-baseline (post-treatment) assessment of efficacy. This population was based on the randomized treatment to which the participant was allocated.|||Score on a scale||Standard Error|Least Squares Mean
2533448|NCT03267264|Secondary|User Experience - Each Individual Study Group|This endpoint analyzes data for individual groups. User experience is assessed through a series of questions reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle). Questions include the subject's perception of: Overall Comfort, Anxiety Associated with a Needle Stick Injury, Injection Pain, and Ease of Use.|30 Days|Per-protocol population|||mm||95% Confidence Interval|Mean
2533449|NCT03267264|Secondary|User Experience - All Study Groups Combined|This is a combined endpoint for all study subjects. User experience is assessed through a series of questions reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle). Questions include the subject's perception of: Overall Comfort, Anxiety Associated with a Needle Stick Injury, Injection Pain, and Ease of Use.|30 Days|Per-protocol population|||mm||95% Confidence Interval|Mean
2533450|NCT03267264|Secondary|Overall User Preference - Each Comparator Group|This endpoint analyzes data for individual groups. User preference is assessed through a single question reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle).|30 Days|Per-protocol population; note that one VAS data point was missing|||mm||95% Confidence Interval|Mean
2533451|NCT03267264|Primary|Overall User Preference -Combined Groups|This is a combined endpoint for all study subjects. User preference is assessed through a single question reported on a 150mm relative VAS scale with the Nucleus Pen labeled at +75 mm and the subject's current pen needle labeled at -75mm. On this scale, zero represents no preference to either pen needle. Relative VAS scores range from -75mm to 75mm; positive scores reflect preference for BD Nucleus and negative scores reflect preference for the comparator (current pen needle).|30 Days|Per-protocol population; note that one VAS data point was missing.|||mm||95% Confidence Interval|Mean
2533452|NCT03267212|Secondary|Change in Tidal Volume During FES-row Testing|Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV|Day 0 and Day 2|Participants who completed both NIV and sham tests|||L||Standard Error|Mean
2533453|NCT03267212|Secondary|Change in Minute Ventilation During FES-row Testing|Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV|Day 0 and Day 2|Participants who completed both NIV and sham tests|||L/min||Standard Deviation|Mean
2533457|NCT03266419|Primary|Minimum Effective Analgesic Dose (MEAD) of Oxycodone at Postoperative Care Unit (PACU)|The patient was administered intravenous oxycodone 2 mg (body weight <80 kg) or 3 mg (>80 kg) every 10 min until the VAS (visual analogue scale)assessments showed that the pain intensity had decreased to <3 at rest and <5 on wound compression. At this point, MEAD of oxycodone was determined. The range of VAS is 0-10 (0 = no pain; 10 = most severe pain).|Through study period in PACU (post anesthesia care unit), up to 2 hours|patients undergoing elective laparoscopic gastrectomy|||mg||Full Range|Median
2533458|NCT03266172|Secondary|Change From Baseline in Body Temperature: Part C|Body temperature was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours|Safety Population|||Degree Celsius||Standard Deviation|Mean
2533459|NCT03266172|Secondary|Change From Baseline in Respiration Rate: Part C|Respiration rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours|Safety Population|||Breaths per minute||Standard Deviation|Mean
2533460|NCT03266172|Secondary|Change From Baseline in Heart Rate: Part C|Heart rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours|Safety Population|||Beats per minute||Standard Deviation|Mean
2533461|NCT03266172|Secondary|Change From Baseline in Blood Pressure: Part C|SBP and DBP was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours|Safety Population|||Millimeters of mercury||Standard Deviation|Mean
2533462|NCT03266172|Secondary|Change From Baseline in Body Temperature: Part B|Body temperature was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1, Pre-dose), Day 1 and Day 3: 2 and 12 hours; Pre-dose on Days 2 and 3; Day 4: 24 hours|Safety Population|||Degree Celsius||Standard Deviation|Mean
2533463|NCT03266172|Secondary|Change From Baseline in Respiration Rate: Part B|Respiration rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value|Baseline (Day 1, Pre-dose), Day 1 and Day 3: 2 and 12 hours; Pre-dose on Days 2 and 3; Day 4 24 hours|Safety Population|||Breaths per minute||Standard Deviation|Mean
2533464|NCT03266172|Secondary|Change From Baseline in Heart Rate: Part B|Heart rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1, Pre-dose), Day 1 and Day 3: 2 and 12 hours; Pre-dose on Days 2 and 3; Day 4: 24 hours|Safety Population|||Beats per minute||Standard Deviation|Mean
2533465|NCT03266172|Secondary|Change From Baseline in Blood Pressure: Part B|SBP and DBP was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1, Pre-dose), Day 1 and Day 3: 2 and 12 hours; Pre-dose on Days 2 and 3; Day 4: 24 hours|Safety Population|||Millimeters of mercury||Standard Deviation|Mean
2533466|NCT03266172|Secondary|Change From Baseline in Body Temperature: Part A|Body temperature was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours|Safety Population.|||Degree Celsius||Standard Deviation|Mean
2533467|NCT03266172|Secondary|Change From Baseline in Respiration Rate: Part A|Respiration rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value|Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours|Safety Population.|||Breaths per minute||Standard Deviation|Mean
2533468|NCT03266172|Secondary|Change From Baseline in Heart Rate: Part A|Heart rate was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1 Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours|Safety Population.|||Beats per minute||Standard Deviation|Mean
2533469|NCT03266172|Secondary|Change From Baseline in Blood Pressure: Part A|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in semi-supine position. Baseline is defined as the latest pre-dose assessment before entering study. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1, Pre-dose), Day 1: 2 and 12 hours; Day 2: 24hours|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimeters of mercury||Standard Deviation|Mean
2533470|NCT03266172|Secondary|Number of Participants Abnormal ECG Findings: Part C|Single 12-lead ECGs was obtained using an ECG machine. PR, QRS, QT and QTc intervals were measured in semi-supine or supine position. Number of participants with any visit post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. Data for worst-case post-Baseline has been reported.|Up to Day 43|Safety Population|||Participants|||Count of Participants
2533471|NCT03266172|Secondary|Number of Participants Abnormal ECG Findings: Part B|Single 12-lead ECGs was obtained using an ECG machine. PR, QRS, QT and QTc intervals were measured in semi-supine or supine position. Number of participants with any visit post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. Data for worst-case post-Baseline has been reported.|Up to Day 22|Safety Population|||Participants|||Count of Participants
2533472|NCT03266172|Secondary|Number of Participants Abnormal Electrocardiogram (ECG) Findings: Part A|Single 12-lead ECGs was obtained using an ECG machine. PR, QRS, QT and Corrected QT (QTc) intervals were measured in semi-supine or supine position. Number of participants with any visit post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported. Data for worst-case post-Baseline has been reported.|Up to Day 43|Safety Population|||Participants|||Count of Participants
2533474|NCT03266172|Secondary|Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part C|"Blood samples were collected to analyze hematology parameters like platelet count, WBC count, hemoglobin, hematocrit, total neutrophils, and lymphocytes. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants are counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing Baseline value are assumed to have normal Baseline value. Hematology parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported."|Up to Day 43|Safety Population|||Participants|||Count of Participants
2533475|NCT03266172|Secondary|Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part C|"Blood samples were collected for analysis of clinical chemistry parameters like albumin, creatinine, glucose, potassium, sodium, AST, ALT, ALP, total bilirubin and calcium. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants are counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing Baseline value are assumed to have normal Baseline value. Clinical chemistry parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported."|Up to Day 43|Safety Population|||Participants|||Count of Participants
2533476|NCT03266172|Secondary|Number of Participants Abnormal Urinalysis Dipstick Results: Part B|Urine samples were collected for analysis of specific gravity, potential of hydrogen ions, glucose, protein, blood and ketones by dipstick method. Microscopic examination were performed if blood or protein values were abnormal.|Up to Day 22|Safety Population|||Participants|||Count of Participants
2533477|NCT03266172|Secondary|Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part B|"Blood samples were collected to analyze hematology parameters like platelet count, WBC count, hemoglobin, hematocrit, total neutrophils, and lymphocytes. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants are counted twice if the subject has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing baseline value are assumed to have normal baseline value. Hematology parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported."|Up to Day 22|Safety Population|||Participants|||Count of Participants
2533478|NCT03266172|Secondary|Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part B|"Blood samples were collected for analysis of clinical chemistry parameters like albumin, creatinine, glucose, potassium, sodium, AST, ALT, ALP, total bilirubin and calcium. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants are counted twice if the subject has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing baseline value are assumed to have normal baseline value. Hematology parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported."|Up to Day 22|Safety Population|||Participants|||Count of Participants
2533479|NCT03266172|Secondary|Number of Participants Abnormal Urinalysis Dipstick Results: Part A|Urine samples were collected for analysis of specific gravity, potential of hydrogen ions, glucose, protein, blood and ketones by dipstick method. Microscopic examination were performed if blood or protein values were abnormal.|Up to Day 43|Safety Population|||Participants|||Count of Participants
2533480|NCT03266172|Secondary|Number of Participants With Emergent Hematology Results by Potential Clinical Importance Criteria: Part A|"Blood samples were collected to analyze hematology parameters like platelet count, white blood cell (WBC) count, hemoglobin, hematocrit, total neutrophils, and lymphocytes. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants are counted twice if the subject has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing baseline value are assumed to have normal baseline value. Hematology parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported."|Up to Day 43|Safety Population|||Participants|||Count of Participants
2533481|NCT03266172|Secondary|Number of Participants With Emergent Clinical Chemistry Results by Potential Clinical Importance Criteria: Part A|"Blood samples were collected for analysis of clinical chemistry parameters like albumin, creatinine, glucose, potassium, sodium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin and calcium. Participants are counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants are counted twice if the subject has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Participants with missing Baseline value are assumed to have normal baseline value. Clinical chemistry parameters with potential clinical importance data has been reported. Data for worst-case post-Baseline has been reported."|Up to Day 43|Safety Population|||Participants|||Count of Participants
2533497|NCT03266172|Secondary|Frelformulation Based on Cmax of GSK2982772 After a High Fat Meal in Part A|Blood samples were collected at indicated time points for analysis of FrelFE based on AUC of GSK2982772 after a high fat meal. Frel for Cmax was calculated as Geometric mean of Cmax of MT Fed formulation (test) / Geometric mean of Cmax of MT Fasted Formulation (reference) multiplied by 100.|Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose|PK Population. Only those participants with data available at specified timepoint were analyzed|||Percentage bioavailability||90% Confidence Interval|Number
2533482|NCT03266172|Secondary|Number of Participants With AE and SAE in Part C|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect and important medical events may jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed before.|Up to Day 43|Safety Population|||Participants|||Count of Participants
2533483|NCT03266172|Secondary|Number of Participants With AE and SAE in Part B|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect and important medical events may jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed before.|Up to Day 22|Safety Population|||Participants|||Count of Participants
2533484|NCT03266172|Secondary|Number of Participants With Adverse Events (AE) and Serious AEs (SAE) in Part A|An AE is any untoward medical occurrence in a clinical study participants, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly or birth defect and important medical events may jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed before. All participants who receive at least 1 dose of study treatment and were included in Safety Population. Participants will be analyzed according to the treatment they actually received.|Up to Day 43|Safety Population|||Participants|||Count of Participants
2533485|NCT03266172|Secondary|Tmax of GSK2982772 After Meal in Part C|Blood samples were collected at indicated time points for analysis of Tmax of GSK2982772 after meal.|Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose|PK Population.|||Hours||Full Range|Median
2533486|NCT03266172|Secondary|Frelformulation Based on Cmax of GSK2982772 After Meal in Part C|Blood samples were collected at indicated time points for analysis of Frelformulation based on Cmax of GSK2982772 after meal. Frel for Cmax was calculated as Geometric mean of Cmax of MM Fed formulation (test) / Geometric mean of Cmax of MM Fasted Formulation (reference) multiplied by 100.|Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose|PK Population|||Percentage bioavailability||90% Confidence Interval|Number
2533487|NCT03266172|Secondary|Frelformulation Based on AUC (0-t) of GSK2982772 After Meal in Part C|Blood samples were collected at indicated time points for analysis of Frelformulation based on AUC of GSK2982772 after meal. Frel for Auc (0-t) was calculated as Geometric mean of AUC (0-t) of MM Fed formulation (fed) / Geometric mean of AUC (0-t) of MM Fasted Formulation (fasted) multiplied by 100.|Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose|PK Population|||Percentage bioavailability||90% Confidence Interval|Number
2533488|NCT03266172|Secondary|AUC(0-12) of GSK2982772 After Meal in Part C|Blood samples were collected at indicated time points for analysis of AUC (0-12) after meal.|Pre-dose and at 2, 4, 6, 8, 10, and 12 hours post-dose|PK Population.|||Hours*microgram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2533489|NCT03266172|Secondary|AUC(0-inf) of GSK2982772 After Meal in Part C|Blood samples were collected at indicated time points for analysis of AUC (0-inf) after meal.|Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose|PK Population. Only participants with data available at the specified time points were analyzed.|||Hours*microgram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2533490|NCT03266172|Secondary|AUC(0-t) of GSK2982772 After Meal in Part C|Blood samples were collected at indicated time points for analysis of AUC (0-t)|Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose|PK Population|||Hours*microgram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2533491|NCT03266172|Secondary|C12 of GSK2982772 After Meal in Part C|Blood samples were collected at indicated time points for analysis of C12|12 hours post-dose|PK Population. Only participants with data available at the specified time points were analyzed.|||Microgram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2533492|NCT03266172|Secondary|Cmax of GSK2982772 After Meal in Part C|Blood samples were collected at indicated time points for analysis of Cmax|Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours|PK Population|||Microgram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2533493|NCT03266172|Secondary|AUC (0-24) of GSK2982772 After Meal in Part C|Blood samples were collected at indicated time points for analysis of AUC (0-24)|Pre-dose and at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24 hours post-dose|PK Population|||Hours*microgram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2533494|NCT03266172|Secondary|Tmax of GSK2982772 in Part B|Blood samples were collected at indicated time points for analysis of Tmax|Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 1 and Day 3|PK Population.|||Hours||Full Range|Median
2533495|NCT03266172|Secondary|Cmax of GSK2982772 in Part B|Blood samples were collected at indicated time points for analysis of Cmax|Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 1 and Day 3|PK Population.|||Microgram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2533496|NCT03266172|Secondary|AUC(0-24) of GSK2982772 in Part B|Blood samples were collected at indicated time points for analysis of AUC (0-24)|Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 1 and Day 3|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours*microgram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2533516|NCT03266172|Primary|AUC(0-inf) of GSK2982772 for IR Formulation in Part C: Fasted State|Blood samples were collected at indicated time points for analysis of AUC (0-inf)|Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose|PK Population. Only those participants with data available at specified time points were analyzed.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533498|NCT03266172|Secondary|Frelformulation Based on AUC (0-inf) of GSK2982772 After a High Fat Meal in Part A|Blood samples were collected at indicated time points for analysis of Frelformulation based on AUC of GSK2982772 after a high fat meal. Frel for AUC (0-inf) was calculated as Geometric mean of AUC (0-inf) of MT Fed formulation (test) / Geometric mean of AUC (0-inf) of MT Fasted Formulation (reference) multiplied by 100.|Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose|PK Population. Only those participants with data available at the specified time points were analyzed.|||Percentage bioavailability||90% Confidence Interval|Number
2533499|NCT03266172|Primary|Frelformulation Based on AUC (0-24) of GSK2982772 in Part C: Fasted State|Blood samples were collected at indicated time points for analysis of Frelformulation. Frel for AUC (0-24) was calculated as Geometric mean of AUC (0-24) of MM Fasted formulation (test) / Geometric mean of AUC (0-24) of IR Formulation (reference) multiplied by 100.|Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose(reference); Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours post-dose(test)|PK Population. Only those participants with data available at the specified data points were analyzed|||Percentage bioavailability||90% Confidence Interval|Number
2533500|NCT03266172|Primary|Frelformulation Based on AUC (0-t) of GSK2982772 in Part C: Fasted State|Blood samples were collected at indicated time points for analysis of Frelformulation. Frel for AUC (0-t) was calculated as Geometric mean of AUC (0-t) of MM formulation (test) / Geometric mean of AUC (0-t) of IR Formulation (reference) multiplied by 100.|Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose(reference); Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose(test)|PK Population.|||Percentage bioavailability||90% Confidence Interval|Number
2533501|NCT03266172|Primary|Ratio of Cmax to C24hour of GSK2982772 for MM Formulation in Part C: Fasted State|Blood samples were collected at indicated time points for analysis of ratio of Cmax to C24hour. Mean and standard deviation of ratio of Cmax to C24 hours has been presented.|Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose|PK Population.|||Ratio||Standard Deviation|Mean
2533502|NCT03266172|Primary|Ratio of Cmax to C24hour of GSK2982772 for IR Formulation in Part C: Fasted State|Blood samples were collected at indicated time points for analysis of ratio of Cmax to C24hour. Mean and standard deviation of ratio of Cmax to C24 hours has been presented.|Pre-dose,0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose|PK Population.|||Ratio||Standard Deviation|Mean
2533503|NCT03266172|Primary|Ratio of Cmax to C12hour of GSK2982772 for MM Formulation in Part C: Fasted State|Blood samples were collected at indicated time points for analysis of ratio of Cmax to C12hour. Mean and standard deviation of ratio of Cmax to C12 hours has been presented.|Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose|PK Population.|||Ratio||Standard Deviation|Mean
2533504|NCT03266172|Primary|Ratio of Cmax to C12hour of GSK2982772 for IR Formulation in Part C: Fasted State|Blood samples were collected at indicated time points for analysis of ratio of Cmax to C12hour. Mean and standard deviation of ratio of Cmax to C12 hours has been presented.|Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose|PK Population.|||Ratio||Standard Deviation|Mean
2533505|NCT03266172|Primary|C24 of GSK2982772 in Part C: Fasted State|Blood samples was collected at indicated time point for analysis of C24|24 hours post-dose|PK Population.|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533506|NCT03266172|Primary|C12 of GSK2982772 in Part C: Fasted State|Blood samples was collected at indicated time point for analysis of C12|12 hours post-dose|PK Population.|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533507|NCT03266172|Primary|Cmax of GSK2982772 for MM Formulation in Part C: Fasted State|Blood samples were collected at indicated time points for analysis of Cmax|Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose|PK Population.|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533508|NCT03266172|Primary|Cmax of GSK2982772 for IR Formulation in Part C: Fasted State|Blood samples were collected at indicated time points for analysis of Cmax|Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose|PK Population.|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533509|NCT03266172|Primary|AUC (0-12) of GSK2982772 for MM Formulation in Part C: Fasted State|Blood samples were collected at indicated time points for analysis of AUC (0-12)|Pre-dose, 2, 4, 6, 8, 10, and 12 hours post-dose|PK Population.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533510|NCT03266172|Primary|AUC (0-12) of GSK2982772 for IR Formulation in Part C: Fasted State|Blood samples were collected at indicated time points for analysis of AUC (0-12)|Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours post-dose|PK Population.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533511|NCT03266172|Primary|AUC(0-24) of GSK2982772 for MM Formulation in Part C: Fasted State|Blood samples were collected at indicated time points for analysis of AUC (0-24)|Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours post-dose|PK Population.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533512|NCT03266172|Primary|AUC(0-24) of GSK2982772 for IR Formulation in Part C: Fasted State|Blood samples were collected at indicated time points for analysis of AUC (0-24)|Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose|PK Population.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533513|NCT03266172|Primary|AUC(0-t) of GSK2982772 for MM Formulation in Part C: Fasted State|Blood samples were collected at indicated time points for analysis of AUC (0-t).|Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose|PK Population.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533514|NCT03266172|Primary|AUC(0-t) of GSK2982772 for IR Formulation in Part C: Fasted State|Blood samples were collected at indicated time points for analysis of AUC (0-t).|Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose|PK Population. Only those participants with data available at specified time frame were analyzed.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533515|NCT03266172|Primary|AUC(0-inf) of GSK2982772 for MM Formulation in Part C: Fasted State|Blood samples were collected at indicated time points for analysis of AUC (0-inf).|Pre-dose, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30 and 32 hours post-dose|PK Population. Only those participants with data available at specified time points were analyzed.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533519|NCT03266172|Primary|Ratio of Cmax to C24hour of GSK2982772 in MT Formulation: Part A|Blood samples were collected at indicated time points for analysis of ratio of Cmax to C24hour. Mean and standard deviation of ratio of Cmax to C24 hour has been presented.|Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose|PK Population. Only participants with data available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2533520|NCT03266172|Primary|Ratio of Cmax to C24hour of GSK2982772 in IR Formulation: Part A|Blood samples were collected at indicated time points for analysis of ratio of Cmax to C24hour. Mean and standard deviation of ratio of Cmax to C24 hour has been presented.|Pre-dose 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose|PK Population|||Ratio||Standard Deviation|Mean
2533521|NCT03266172|Primary|Ratio of Cmax to C12hour of GSK2982772 in MT Formulation: Part A|Blood samples were collected at indicated time points for analysis of ratio of Cmax to C12hour. Mean and standard deviation of ratio of Cmax to C12 hour has been presented.|Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose|PK Population. Only participants with data available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2533522|NCT03266172|Primary|Ratio of Cmax to C12hour of GSK2982772 in IR Formulation: Part A|Blood samples were collected at indicated time points for analysis of ratio of Cmax to C12hour. Mean and standard deviation of ratio of Cmax to C12 hour has been presented.|Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 26, 28, 30 and 32 hours post-dose|PK Population|||Ratio||Standard Deviation|Mean
2533523|NCT03266172|Primary|Frelformulation Based on Cmax of GSK2982772 in Part A|Blood samples were collected at indicated time points for analysis of Frelformulation. Frel was calculated as Geometric mean of Cmax of MT Formulation (test)/ Geometric mean of Cmax of IR Formulation (reference) multiplied by 100.|Pre-dose,0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose(reference); Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose(test)|PK Population. Only those participants with data available at specified time frame were analyzed.|||Percentage bioavailability||90% Confidence Interval|Number
2533524|NCT03266172|Primary|Frelformulation Based on AUC (0-24) of GSK2982772 in Part A|Blood samples were collected at indicated time points for analysis of Frelformulation. Frelformulation for AUC (0-24) was calculated as Geometric mean of AUC (0-24) of MT (test) / Geometric mean of AUC (0-24) of IR Formulation (reference) multiplied by 100.|Pre-dose 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose (reference); Pre-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose (test)|PK Population. Only those participants with data available at specified time frame were analyzed.|||Percentage bioavailability||90% Confidence Interval|Number
2533525|NCT03266172|Primary|Relative Bioavailability (Frelformulation) Based on AUC (0-inf) of GSK2982772 in Part A|Blood samples were collected at indicated time points for analysis of Frelformulation. Frelformulation for AUC (0-inf) was calculated as Geometric mean of AUC (0-inf) of MT (test) / Geometric mean of AUC (0-inf) of IR Formulation (reference) multiplied by 100.|Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose (reference); Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose (test)|PK Population. Only those participants with data available at specified time frame were analyzed.|||Percentage bioavailability||90% Confidence Interval|Number
2533526|NCT03266172|Primary|Concentration at 24 Hours Post-dose (C24hour) of GSK2982772 in Part A|Blood samples were collected from participants at indicated time points and analyzed for C24hour.|24 hours post-dose|PK Population. Only participants with data available at the specified time points were analyzed.|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533527|NCT03266172|Primary|Concentration at 12 Hours Post-dose (C12hour) of GSK2982772 in Part A|Blood samples were collected from participants at indicated time points and analyzed for C12hour.|12 hours post-dose|PK Population. Only participants with data available at the specified time points were analyzed.|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533528|NCT03266172|Primary|Cmax of GSK2982772 in MT Formulation: Part A|Blood samples were collected from participants at indicated time points and analyzed for Cmax|Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose|PK Population. Only participants with data available at the specified time points were analyzed.|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533529|NCT03266172|Primary|Maximum Observed Concentration (Cmax) of GSK2982772 in IR Formulation: Part A|Blood samples were collected from participants at indicated time points and analyzed for Cmax|Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose|PK Population|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533530|NCT03266172|Primary|AUC(0-12) of GSK2982772 in MT Formulation: Part A|Blood samples were collected from participants at indicated time points and analyzed for AUC (0-12)|Pre-dose, 2, 4, 6, 8, 10, and 12 hours post-dose|PK Population. Only participants with data available at the specified time points were analyzed.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533531|NCT03266172|Primary|Area Under the Curve From Time Zero to 12 Hours (AUC[0-12]) of GSK2982772 in IR Formulation: Part A|Blood samples were collected from participants at indicated time points and analyzed for AUC (0-12)|Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours post-dose|PK Population.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533532|NCT03266172|Primary|AUC(0-24) of GSK2982772 in MT Formulation: Part A|Blood samples were collected from participants at indicated time points and analyzed for AUC (0-24)|Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose|PK Population. Only those participants with data available at specified time frame were analyzed|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533533|NCT03266172|Primary|Area Under the Curve From Time Zero to 24 Hours (AUC[0-24]) of GSK2982772 in IR Formulation: Part A|Blood samples were collected from participants at indicated time points and analyzed for AUC (0-24)|Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose|PK Population.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533534|NCT03266172|Primary|AUC(0-t) of GSK2982772 in MT Formulation: Part A|Blood samples were collected from participants at indicated time points and analyzed for AUC (0-t)|Pre-dose, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 26, 28, 30 and 32 hours post-dose|PK Population. Only those participants with data available at specified time frame were analyzed.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533537|NCT03266172|Primary|Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of GSK2982772 in IR Formulation: Part A|Blood samples were collected from participants at indicated time points and analyzed for AUC (0-inf). Participants in the 'Safety Population' for whom a Pharmacokinetic (PK) sample was obtained and analyzed were part of PK Population.|Pre-dose, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose|PK Population.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533538|NCT03265600|Secondary|Multidimensional Assessment of Interoceptive Awareness (MAIA)|The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item self-report scale designed to assess 8 aspects of interoceptive awareness : noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trusting. Participants are asked to rate their awareness of interoceptive experiences on a 6-point Likert scale from 0 (Never) to 5 (Always). Each subscale has 3-7 items, and scores are obtained by reverse coding items 5, 6, 7, 8, 9, and then taking the average of items in each scale. Scores range from 0-5, with higher scores indicating better results (greater interoception).|Baseline and week 8 (pre to post Intervention)|We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models|||score on a scale||Standard Deviation|Mean
2533539|NCT03265600|Secondary|Difficulty in Emotion Regulation Scale (DERS)|The Difficulties in Emotion Regulation (DERS) Scale is a 36-item self-report scale designed to assess emotional dysregulation. Participants are asked to rate how often they have emotional dysregulation on a 5-point Likert scale from 1 (almost never [0-10%]) to 5 (almost always [91-100%]). The scale assess 6 aspects of emotional dysregulation: non-acceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness (reverse-scored), limited access to emotion regulation strategies, and lack of emotional clarity. Total scores range from 5-180, with higher scores indicating worse results (more difficulty in emotional regulation).|Baseline and week 8 (pre to post Intervention)|We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models|||score on a scale||Standard Deviation|Mean
2533540|NCT03265600|Secondary|Perceived Control Questionnaire (PCQ)|The Perceived Control Questionnaire (PCQ) is adapted from a 5-item perceived control measure from Jerant et al. and a previously validated survey from Armitage et al. This 5-item scale asks participants to rate their sense of control over chronic illness self-management on a 7-point scale from 1 (None) to 7 (Total). Scores range from 5-35, with higher scores indicating better results (greater sense of control).|Baseline and week 8 (pre to post Intervention)|We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models|||score on a scale||Standard Deviation|Mean
2533541|NCT03265600|Secondary|Change in Self-Efficacy for Managing Chronic Disease (SECD-6)|The Self-Efficacy for Managing Chronic Disease Scale (SECD-6) is a 6-item scale that is used to evaluate a participant's ability to self-manage care for a chronic disease. SECD-6 asks participants to rate their confidence in their own ability to do certain activities, on a scale from 1 (not at all confident) to 10 (totally confident). Higher scores indicate better results (higher levels of self-efficacy).|Baseline and week 8 (pre to post Intervention)|We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models|||score on a scale||Standard Deviation|Mean
2533542|NCT03265600|Secondary|Self-Compassion Scale-Short Form (SCS-SF)|The short-form Self-Compassion Scale (SCS-SF) is an abbreviated 12-item form of the original 26-item Self-Compassion Scale. The scale is scored on a 5 point Likert scale (1 = Almost never; 5 = Almost always), and negative subscale items are reverse scored, with higher scores indicating greater levels of self-compassion.|Baseline and week 8 (pre to post Intervention)|We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models|||score on a scale||Standard Deviation|Mean
2533543|NCT03265600|Secondary|Five Facet Mindfulness Questionnaire (FFMQ)|"The Five Facet Mindfulness Questionnaire (FFMQ) is a 39-item scale that examines five factors that represent aspects of the current empirical conception of mindfulness. These five facets include: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Participants rate their degree of agreement with each of the items on a Likert-type scale ranging from 1 (Never or very rarely true) to 5 (Very often or always true). Facet scores range from 8−40, with the exception of the nonreactivity facet, which ranges from 7−35. Total scores range from 39-195, with higher scores reflecting higher levels of mindfulness (a better outcome)."|Baseline and week 8 (pre to post Intervention)|We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models|||score on a scale||Standard Deviation|Mean
2533544|NCT03265600|Primary|Patient Reported Outcomes Measurement Information System - Depression Short Form (PROMIS-DSF)|The Patient Reported Outcomes Measurement Information System - Depression Short Form 8a (PROMIS-DSF) is an 8-item scale used to assess patient-reported health status for depression. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects reflect worse results (greater symptom severity).|Baseline and week 8 (pre to post Intervention)|We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models|||score on a scale||Standard Deviation|Mean
2533545|NCT03265600|Primary|Patient Reported Outcomes Measurement Information System - Anxiety Short Form (PROMIS-ASF)|The Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale used to assess patient-reported health status for anxiety. PROMIS instruments are funded by the National Institutes of Health (NIH) and used to reliably and validly measure patient-reported outcomes for clinical research and practice. Participants are asked to rate their experience of the item in the past seven days on a 5-point Likert scale from 1 (Never) to 5 (Always). The values of the response to each question are summed into a raw score ranging from 8-40. The raw score is then rescaled with use of the PROMIS Assessment Center Scoring Service into a T score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-Score reflects worse results (greater symptom severity).|Baseline and week 8 (pre to post Intervention)|We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models|||score on a scale||Standard Deviation|Mean
2533546|NCT03265600|Primary|Perceived Stress Scale|The Perceived Stress Scale (PSS) (10 items) measures the degree to which situations in life are stressful. Items are designed to evaluate how overloaded, unpredictable, and uncontrollable one finds one's life. Each item is scored on a 5 point Likert scale from 0 (Never) to 4 (Very often). Scores range from 0-40 with higher scores reflecting worse results (more stress).|Baseline and week 8 (pre to post Intervention)|We conducted a difference-in-differences, ITT, repeated measures analysis using linear mixed effects models|||score on a scale||Standard Deviation|Mean
2533547|NCT03265600|Primary|Action Plan Initiation Survey (APIS-5)|"The Action Plan Initiation Survey (APIS-5) is a 5-item self-report questionnaire adapted from a measure used by Guck et al. Participants are asked to indicate how successful they were in meeting a previously set Action Plan by using a 7-point Likert scale from 1 (Not met at all) to 7 (Totally met), with a score of 5 or above indicating successful initiation of the goal. For each unmet goal, patients are asked to further rate the cause of not meeting the goal by using a 7-point Likert rating scale from 1 (Extremely controllable) to 7 (Not at all controllable).~For this outcome we reported the number of participants in each arm who successfully initiated an Action Plan, as indicated by a score of 5 or above in reporting whether they were able to meet their action plan goal."|Weeks 8-10|Using mixed effects intent-to-treat analysis, we defined non-initiator status as participants who never endorsed greater than 4 or who did not complete the API survey. by week 9. The APIS-5 is analyzed using an intent to treat analysis and missing APIS is considered incomplete action plan initiation.|||Participants|||Count of Participants
2533548|NCT03265132|Secondary|Change From Baseline in Neopterin.|Only results from Week 2 reported here|Week 2||||nmol/L||Standard Deviation|Mean
2533549|NCT03265132|Secondary|Change From Baseline in Serum Calprotectin.|Change from baseline in serum calprotectin. Only results from Week 2 reported here|Week 2||||mg/L||Standard Deviation|Mean
2533550|NCT03265132|Secondary|Change From Baseline in IL-18.|Only results from Week 2 reported here|Week 2||||ng/L||Standard Deviation|Mean
2533551|NCT03265132|Secondary|Change From Baseline in IL-6.|Only results from Week 2 reported here.|Week 2||||ng/L||Standard Deviation|Mean
2533552|NCT03265132|Secondary|Proportion of Patients With Inactive Disease.|Inactive disease is a composite of the following parameters: no joints with active arthritis, no fever, no rash, no serositis, no splenomegaly, no generalized lymphadenopathy attributable to Still's disease, CRP level within normal limits, physician's global assessment of disease activity score below 10 mm on a 100 mm VAS and a documented morning stiffness ≤15 minutes.|Week 12||||Participants|||Count of Participants
2533553|NCT03265132|Secondary|Number of Days Off School or Work Due to Still's Disease.|Number of days off school or work due to Still's disease week 1-2.|Week 2||||Days||Standard Deviation|Mean
2533554|NCT03265132|Secondary|Change From Baseline in JADAS27.|"Juvenile Arthritis Disease Activity Score (JADAS) includes 4 measures: physician global assessment of disease activity, patient or parent global assessment of overall well-being, 27 active joint count, and CRP. The JADAS27 includes the 27 joints. JADAS27 is calculated as the sum of its four components, physician global assessment of disease activity converted to cm from the VAS (0=no activity, 10=maximum activity); patient global assessment of well-being converted to cm from the VAS (0=very well, 10=very poor); active joint count (0-27); and CRP. Prior to calculation CRP is truncated to a 0 - 10 scale according to the following formula: (CRP (mg/l) −10)/10. Before calculation, CRP values <10 mg/l are converted to 10 and CRP values >110 mg/l are converted to 110. The JADAS27 tool yields a global score of 0-57.~Only results from Week 2 reported here."|Week 2||||score on a scale||Standard Deviation|Mean
2533555|NCT03265132|Secondary|Anakinra Serum Pharmacokinetic Parameter: Vd/F|PK parameters only available for 2 patients|Week 12|PK parameters only available for 2 anakinra treated patients|||mL/kg||Standard Deviation|Mean
2533556|NCT03265132|Secondary|Anakinra Serum Pharmacokinetic Parameter: CL/F|Pharmacokinetic parameters only available for 2 patients|Week 12|Pharmacokinetic parameters only available for 2 anakinra treated patients|||mL/h*kg||Standard Deviation|Mean
2533557|NCT03265132|Secondary|Anakinra Serum Pharmacokinetic Parameter: AUC 0-24 h|PK parameters only available for 2 patients|Week 12|PK parameters only available for 2 anakinra treated patients|||h*ng/mL||Standard Deviation|Mean
2533558|NCT03265132|Secondary|Anakinra Serum Pharmacokinetic Parameters, Tmax and T½|PK parameters only available for 2 patients|Week 12|PK parameters only available for 2 patients|||hours||Standard Deviation|Mean
2533559|NCT03265132|Secondary|Anakinra Serum Pharmacokinetic Parameters: Cmax,|PK parameters only available for 2 patients.|Week 12|PK parameters only available for 2 anakinra treated patients.|||ng/mL||Standard Deviation|Mean
2533560|NCT03265132|Secondary|Anakinra Serum Pre-dose Concentrations.|Week 2 reported here.|Week 2|No data available for the placebo group as they did not receive anakinra.|||ng/mL||Standard Deviation|Mean
2533561|NCT03265132|Secondary|Proportion of Patients With Neutralizing Antibodies.|Confirmed ADA positive samples will be analyzed for the presence of neutralizing antibodies.|Week 2||||Participants|||Count of Participants
2533562|NCT03265132|Secondary|Proportion of Patients With Antidrug Antibodies (ADA) Against Anakinra.|Proportion of patients with antidrug antibodies (ADA) against anakinra.|Week 2||||Participants|||Count of Participants
2533563|NCT03265132|Secondary|Proportion of Patients With Macrophage Activation Syndrome (MAS).|Proportion of patients with Macrophage Activation Syndrome (MAS).|From Day 1 to Week 16||||Participants|||Count of Participants
2533564|NCT03265132|Secondary|Proportion of Patients With at Least One Serious Adverse Event Including Death.|Serious adverse events (SAEs) will be collected from informed consent up to 28 days after stopping study treatment.|From Informed consent to Week 16||||Participants|||Count of Participants
2533565|NCT03265132|Secondary|Proportion of Patients With at Least One Adverse Event.|All adverse events collected from start of study treatment up to 28 days after stopping study treatment.|From Day 1 to Week 16||||Participants|||Count of Participants
2533566|NCT03265132|Secondary|Percentage Decrease of the Glucocorticoid Dose From Baseline.|Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available|From Day 1 to Week12|||||||
2533567|NCT03265132|Secondary|Proportion of Patients That Have Decreased the Glucocorticoid Dose With at Least 50% From Baseline.|Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available|From Week 2 to Week12|||||||
2533578|NCT03265132|Secondary|Proportion of Patients With Sustained ACR30, ACR50, ACR70 and ACR90 Response.|Proportion of patients that still meet the corresponding week 2 response with absence of fever in the preceding 7 days. Only the strictest criteria, ACR90, is reported here.|Week 12||||Participants|||Count of Participants
2533579|NCT03265132|Secondary|Change From Baseline in CRP.|Change from baseline in C-Reactive Protein (CRP). CRP is measured in mg/L.|Day 1 and Week 1||||mg/L||Standard Deviation|Mean
2533580|NCT03265132|Secondary|Change From Baseline in Patient/Parent Global Assessment of Overall Well-being at Week 1.|Change from baseline in patient/parent global assessment of overall well-being measured on a VAS 0 (very well)-100 (very poor) at Week 1.|Day 1 and Week 1||||mm||Standard Deviation|Mean
2533581|NCT03265132|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Week 1.|Change from baseline in Physician global assessment of disease activity measured on a VAS 0 (very well)-100 (very poor) at Week 1.|Day 1 and Week 1||||mm||Standard Deviation|Mean
2533582|NCT03265132|Secondary|Proportion of Patients With Absence of Fever During the 24 Hours Preceding Week 1.|Absence of fever during the 24 hours preceding week 1.|Week 1||||Participants|||Count of Participants
2533583|NCT03265132|Secondary|Proportion of Patients With Absence of Fever During the 7 Days Preceding Week 2.|Proportion of patients with absence of fever during the 7 days preceding Week 2.|Week 2||||Participants|||Count of Participants
2533584|NCT03265132|Secondary|Proportion of Responders in CRP (mg/L).|Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.|Week 2||||Participants|||Count of Participants
2533585|NCT03265132|Secondary|Proportion of Responders in Assessment of Physical Function (CHAQ/SHAQ).|Childhood Health Assessment Questionnaire (CHAQ) and Stanford Health Assessment Questionnaire (SHAQ) assess physical and functional status (see Clinical protocol section 6.5.4.1.5). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.|Week 2||||Participants|||Count of Participants
2533586|NCT03265132|Secondary|Proportion of Responders in Number of Joints With Limitation of Motion.|Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.|Week 2||||Participants|||Count of Participants
2533587|NCT03265132|Secondary|Proportion of Responders in Number of Joints With Active Arthritis.|Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.|Week 2||||Participants|||Count of Participants
2533588|NCT03265132|Secondary|Proportion of Responders in Patient/Parent Global Assessment of Overall Well-being.|Assessed on a VAS from very well (0 mm) to very poor. (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.|Week 2||||Participants|||Count of Participants
2533589|NCT03265132|Secondary|Proportion of Responders in Physician Global Assessment of Disease Activity.|Assessed on a VAS from no disease activity (0 mm) to very severe disease activity (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.|Week 2||||Participants|||Count of Participants
2533590|NCT03265132|Secondary|Proportion of ACR90 Responders With Absence of Fever During 7 Days Preceding Week 2.|ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome . Also no more than 1 of the 6 variables may worsen by >30% from baseline.|Week 2||||Participants|||Count of Participants
2533591|NCT03265132|Secondary|Proportion of ACR70 Responders With Absence of Fever During 7 Days Preceding Week 2.|ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome. Also no more than 1 of the 6 variables may worsen by >30% from baseline.|Week 2||||Participants|||Count of Participants
2533592|NCT03265132|Secondary|Proportion of ACR50 Responders With Absence of Fever During 7 Days Preceding Week 2.|ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by >30% from baseline.|Week 2||||Participants|||Count of Participants
2533593|NCT03265132|Secondary|Proportion of ACR90 Responders With Absence of Fever During 24 Hours Preceding Week 1.|ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by >30% from baseline.|Week 1||||Participants|||Count of Participants
2533594|NCT03265132|Secondary|Proportion of ACR70 Responders With Absence of Fever During 24 Hours Preceding Week 1.|ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by >30% from baseline.|Week 1||||Participants|||Count of Participants
2533595|NCT03265132|Secondary|Proportion of ACR50 Responders With Absence of Fever During 24 Hours Preceding Week 1.|ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by >30% from baseline.|Week 1||||Participants|||Count of Participants
2533596|NCT03265132|Secondary|Proportion of ACR30 Responders With Absence of Fever During 24 Hours Preceding Week 1.|ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by >30% from baseline.|Week 1||||Participants|||Count of Participants
2533597|NCT03265132|Primary|Proportion of ACR30 Responders With Absence of Fever Attributable to the Disease During the 7 Days Preceding Week 2.|"ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed below. Also no more than 1 of the 6 variables may worsen by >30% from baseline. (ACR: American College of Rheumatology)~Physician global assessment of disease activity - Assessed on a Visual Analogue Scale (VAS) from no disease activity (0 mm) to very severe disease activity (100 mm).~Patient/parent global assessment of overall well-being - Assessed on a VAS from very well (0 mm) to very poor (100 mm).~Number of joints with active arthritis.~Number of joints with limitation of motion.~Assessment of physical function - Patient Reported Outcome instruments : Childhood Health Assessment Questionnaire (CHAQ) /Stanford Health Assessment Questionnaire (SHAQ).~C-Reactive Protein (CRP) (mg/L)."|Week 2||||Participants|||Count of Participants
2533598|NCT03265119|Secondary|Clinical Global Impression - Global Improvement (CGI -I) Response|"The CGI-I item is rated on a 7-point scale from 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse.~Response is defined as achieving a CGI-I score of 1 or 2, scores of 3 to 7 or missing are defined as Non Response"|Visit 8 (Week 6)|Full Analysis Set|||Participants|||Count of Participants
2533599|NCT03265119|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale, Version 5 (ADHD-RS-5) Total Score|"The ADHD-RS-5 is comprised of 18 frequency items and 12 impairment items. Each frequency item was scored on a scale from 0 = Never or rarely to 3 = Very often.~The ADHD-RS-5 total score was calculated as the sum of the 18 frequency item scores. The total score ranges from 0 to 54. Higher scores indicate greater symptom severity. Change from baseline value were calculated as the assessment value minus the baseline value."|Baseline to Visit 8 (Week 6)|Full Analysis Set|||units on a scale||Standard Error|Least Squares Mean
2533600|NCT03264456|Secondary|Follow-up|Changes in primary lesion maximum SUV between pretreatment PET/MRI and followup PET/MRI following 8 weeks of androgen deprivation therapy (ADT)|Baseline through 8 weeks|Number of patients in total cohort who underwent ADT|||standardized uptake values||Standard Deviation|Mean
2533601|NCT03264456|Secondary|Number of Patients With Nodal Metastases Detected on PET/MRI vs. MRI|Compare number of patients with nodal metastases detected on [18F]fluciclovine PET/MRI to number of patients with metastases detected on prostate MRI alone.|Baseline through 24 hours|Total number of patients who demonstrated nodal metastatic disease on fluciclovine-PET/MRI|||Participants|||Count of Participants
2533602|NCT03264456|Primary|Number of Patients With Nodal Metastases Detected on Fluciclovine-PET/MRI|Number of patients with nodal metastases detected on [18F]fluciclovine PET/MRI|Baseline through 24 hours||||Participants|||Count of Participants
2533603|NCT03264456|Primary|Number of Patients With Primary Lesions Detected|Number of patients with primary lesions detected on 18-F fluciclovine PET/MRI|Baseline through 24 hr||||Participants|||Count of Participants
2533604|NCT03264248|Secondary|Depression Score at Baseline|Depression scale determined by using the Center for Epidemiology Studies-Depression score. In scoring the CES-D, a value of 0, 1, 2 or 3 is assigned to a response depending upon whether the item is worded positively or negatively.. Possible range of scores is averaged to equal 0 to 60, with the higher scores indicating the presence of more symptomatology|Baseline only|Outcome was only measured during baseline as a screening measurement, subjects were not eligible with a CES-D of > 20. Since there is only one group, this outcome variables was calculated using the CES-D scoring chart.|||units on a scale||Standard Deviation|Mean
2533605|NCT03264248|Secondary|Body-fat Percentage Change|Change in body fat percentage|13 weeks|Subject #7 only used the scale twice during the study therefore change in body fat percentage was not able to be calculated. Since there is only one group, this outcome variables was analyzed using summary statistics and paired t-tests.|||percentage of pounds||Standard Deviation|Mean
2533606|NCT03264248|Secondary|Abdominal Girth Change|Change in abdominal girth|baseline and 13 weeks|Since there is only one group, this outcome variables was analyzed using summary statistics and paired t-tests.|||inches||Standard Deviation|Mean
2533607|NCT03264248|Primary|Weight Change|Change in body weight|baseline and 13 weeks|Since there is only one group, this outcome variables was analyzed using summary statistics and paired t-tests.|||pounds||Standard Deviation|Mean
2533608|NCT03264157|Secondary|RVNA Geometric Mean Titers at Days 14, 28, 49 and 140|Comparison of the GMTs for antirabies antibody titer after administration of BPL HRIG and vaccine versus comparator HRIG and vaccine to assess the inhibitory effects of BPL HRIG on active immunization relative to that of the comparator HRIG.|Days 14, 28, 49 and 140|Secondary PK population (subjects who receive the full dose of BPL HRIG or comparator HRIG and all 5 doses of active rabies vaccine and for whom all required PK samples are taken).|||IU/mL||95% Confidence Interval|Geometric Mean
2533609|NCT03264157|Secondary|Proportion of Subjects Reaching Antirabies Antibody Titer of ≥ LLOQ of the Assay by Visit|The proportion of subjects reaching antirabies antibody titer of ≥ LLOQ of the assay at each visit after administration of BPL HRIG and vaccine versus comparator HRIG and vaccine.|Days 3, 5, 7, 14, 28, 49, and 140|Primary PK population (all subjects who receive the full dose of BPL HRIG or comparator HRIG and the first 3 doses of active rabies vaccine on Days 0, 3, 7 and for whom the PK sample at Day 14 is taken).|||Participants|||Count of Participants
2533610|NCT03264157|Secondary|Proportion of Subjects Reaching Antirabies Antibody Titer of ≥ 0.5 IU/mL by Visit|The proportion of subjects reaching antirabies antibody titer of ≥ 0.5 IU/mL after administration of BPL HRIG and vaccine versus comparator HRIG and vaccine.|Days 3, 5, 7, 14, 28, 49, and 140|Primary PK population (all subjects who receive the full dose of BPL HRIG or comparator HRIG and the first 3 doses of active rabies vaccine on Days 0, 3, 7 and for whom the PK sample at Day 14 is taken).|||Participants|||Count of Participants
2533611|NCT03264157|Secondary|RVNA Geometric Mean Titers at Days 3, 5, 7 and 14|Comparison of the geometric mean titers (GMTs) for antirabies antibody titer after administration of BPL HRIG and vaccine versus comparator HRIG and vaccine. The median peak RVNA titer occurred at Day 14, which is reflected in the analysis. The RVNA titer to peak geometric mean is analyzed using a repeated measures analysis. The inferential test compares RVNA values between BPL HRIG and HyperRab in a single analysis across all visits at or below the visit at which peak titer is observed. The geometric mean values presented represent a mean across all visits from baseline through and including Day 14.|Days 3, 5, 7 and 14|Secondary PK population (subjects who receive the full dose of BPL HRIG or comparator HRIG and all 5 doses of active rabies vaccine and for whom all required PK samples are taken).|||IU/mL||95% Confidence Interval|Geometric Mean
2533612|NCT03264157|Secondary|Analysis of AUC0-7d|The AUC0-7d for BPL HRIG and vaccine versus comparator HRIG and vaccine using a non inferiority margin of 20%.|Day 0 to Day 7|Primary PK population (all subjects who receive the full dose of BPL HRIG or comparator HRIG and the first 3 doses of active rabies vaccine on Days 0, 3, 7 and for whom the PK sample at Day 14 is taken).|||day*IU/mL||95% Confidence Interval|Geometric Mean
2533613|NCT03264157|Primary|Proportion of Subjects With Anti-rabies Antibody Titer of ≥0.5 IU/mL|Non-inferiority in terms of the proportion of subjects with anti-rabies antibody titer of ≥0.5 IU/mL after study drug administration using a non-inferiority margin of 10%.|Day 14|Primary PK population (all subjects who receive the full dose of BPL HRIG or comparator HRIG and the first 3 doses of active rabies vaccine on Days 0, 3, 7 and for whom the PK sample at Day 14 is taken).|||Participants|||Count of Participants
2533616|NCT03263806|Secondary|Diagnostic Effectiveness|Proportion of accurate triage using FFR measured at heart catheterization (CATH-FFR) among all patients triaged to heart catheterization by each strategy|3 months after initial presentation|Study terminated with NO data collected.||||||
2533617|NCT03263806|Primary|Catheterization Rate|Percent of patients undergoing heart catheterization|3 months after initial presentation|Study terminated with NO data collected.||||||
2533618|NCT03263702|Secondary|Number of Serious Adverse Events||12 months||||number of occurrences|||Number
2533619|NCT03263702|Secondary|Number of Major Adverse Cardiac Events (MACE)||12 months||||number of occurrences|||Number
2533620|NCT03263702|Secondary|Number of Procedure-related Adverse Events||up to 12 months||||number of occurrences|||Number
2533621|NCT03263702|Secondary|Duration of Procedure Time|Duration of RADAR procedure time|Day 1||||minutes||Standard Deviation|Mean
2533622|NCT03263702|Secondary|Duration of Exposure|Radiation exposure due to fluoroscopy during the AF ablation procedure|Day 1||||mGy||Standard Deviation|Mean
2533623|NCT03263702|Secondary|Duration of Fluoro Time|Duration of fluoroscopy used during the AF ablation procedure|Day 1||||minutes||Standard Deviation|Mean
2533624|NCT03263702|Secondary|Duration of RF Ablation|Amount of radiofrequency ablation used for atrial fibrillation ablation|Day 1||||minutes||Standard Deviation|Mean
2533625|NCT03263702|Secondary|Rate of Post-ablation Inducibility of AF|Post-ablation inducibility of AF (> 5 mins) with burst pacing|Day 1||||percent of occurences|||Number
2533626|NCT03263702|Primary|Number of Participants Free From Recurrent AT/AF With no or Some AAD|Number of Participants Free recurrent Atrial Tachycardia/Atrial Fibrillation with either some or no use of Anti-Arrhythmic Drugs|at 12 months||||Participants|||Count of Participants
2533627|NCT03263702|Primary|Number of Participants Free From Recurrent AT/AF on no AAD|Number of Participants freedom from recurrent Atrial Tachycardia/Atrial Fibrillation with no use of Anti-Arrhythmic Drugs (AAD)|at 12 months||||Participants|||Count of Participants
2533628|NCT03263702|Primary|Number of Participants With Atrial Fibrillation Termination|Acute Procedural Outcomes as defined by termination of Atrial Fibrillation into NSR or AT|Day 1||||Participants|||Count of Participants
2533629|NCT03262233|Primary|Change in Relative Unpredictable Stressor Reactivity|A difference score of relative unpredictable stressor reactivity during the second administration of the NPU stressor task relative to the first NPU stressor task|baseline and up to 14 days post cessation attempt (non-deprived groups); baseline and up to 24 hours post quit attempt (deprived groups)||||change in microvolts||Standard Deviation|Mean
2533630|NCT03262233|Primary|Change in Overall Stressor Reactivity|A difference score of overall stressor reactivity during the second administration of the NPU stressor task relative to the first NPU stressor task|baseline and up to 14 days post cessation attempt (non-deprived groups); baseline and up to 24 hours post quit attempt (deprived groups)||||change in microvolts||Standard Deviation|Mean
2533631|NCT03262233|Primary|Relative Unpredictable Stressor Reactivity|Unpredictable startle potentiation minus predictable startle potentiation during the first administration of the NPU stressor task|up to 24 hours post cessation attempt (deprived groups); during normal smoking prior to quit attempt, ie. Baseline (non-deprived groups)||||microvolts||Standard Deviation|Mean
2533632|NCT03262233|Primary|Overall Stressor Reactivity|The average of unpredictable startle potentiation and predictable startle potentiation during the first administration of the NPU stressor task.|up to 24 hours after start of cessation attempt (deprived groups); during normal smoking prior to quit attempt, ie. Baseline (non-deprived groups)||||microvolts||Standard Deviation|Mean
2533633|NCT03261531|Secondary|Change in Fasting and Peak Postprandial Peptide Tyrosine Tyrosine (PYY) at 3 Months|Peptide Tyrosine Tyrosine (PYY) will be measured by radioimmunoassay.|baseline, 90 minutes postprandially|Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data||||||
2533634|NCT03261531|Secondary|Change in Fasting and Peak Postprandial Glucagon-like Peptide-1 (GLP-1) at 3 Months|Glucagon-like peptide-1 (GLP-1) will be measured by a radioimmunoassay technique.|baseline, 90 minutes postprandially|Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data||||||
2533635|NCT03261531|Secondary|Change in Fasting and Peak Postprandial Plasma Ghrelin at 3 Months|Total ghrelin will be measured by a radioimmunoassay technique.|baseline, 90 minutes postprandially|Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data||||||
2533636|NCT03261531|Secondary|Change in Appetite Score|Ratings of appetite will be measured every 30 minutes between the time of ingestion of standard liquid breakfast and the start of the ad libitum meal. The appetite rating will be measured by 4- 100 mm long Visual Analog Scales (VAS). The VAS does not have any pre-set marks between the extremes of 0 for negative rating and 100 mm for positive rating. The investigator measures the mark made by the participant in mm and records this for the value. The overall appetite score will be calculated as the average of the four individual scores (satiety + fullness+100-prospective food consumption + hunger/4.|Baseline, 3 months|Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data||||||
2533637|NCT03261531|Secondary|Mean Kcal Intake at Buffet Meal as a Measure of Appetite|"Assessment of kcal intake as a measure of appetite buffet meal to measure total caloric intake. 5 hours after ingesting 300 mL liquid nutrient as part of the gastric volume study, participants will be invited to eat, during a 30-minute period, a standard free feeding meal. The total amount of food consumed will be analyzed by the study dietitian."|At 3 months, approximately 30 minutes after the buffet meal|Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data||||||
2533638|NCT03261531|Secondary|Satiation Maximum Tolerated Volume (Level 5)|"Subjects will ingest a liquid nutrient drink at a rate of 120 mL every 4 minutes; the volume ingested at each level of fullness will be recorded. Participants record their sensations of fullness using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal (volume to fullness), and level 5 corresponding to the maximum tolerated volume (MTV). Nutrient intake is stopped when subjects reach the score of 5."|Approximately 30 minutes after the liquid meal|Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data||||||
2567340|NCT02568007|Secondary|Anthropometrics: Skin Fold Thickness|Change in skin fold thickness as measured by centimeters and z-score percentiles|two months|Too few patients to analyze||||||
2533639|NCT03261531|Secondary|Satiation Volume (Level 3)|"Subjects will ingest a liquid nutrient drink at a rate of 120 mL every 4 minutes; the volume ingested at each level of fullness will be recorded. Participants record their sensations of fullness using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal (volume to fullness), and level 5 corresponding to the maximum tolerated volume (MTV). Nutrient intake is stopped when subjects reach the score of 5."|Approximately 30 minutes after the liquid meal|Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data||||||
2533640|NCT03261531|Secondary|Change in Gastric Emptying Percentage|The time for gastric retention of ingested solids or liquid to leave the stomach, measured in percentage.|Day 1, 3 months|Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data||||||
2533641|NCT03261531|Secondary|Postprandial Gastric Volume (Gastric Accommodation) by 99mTc-SPECT Imaging|A noninvasive SPECT method will be used to measure gastric volume after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC will be given by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication (99mTc) will be given subcutaneously. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans will be obtained. Each scan requires about 9-12 min. Tomographic images of the gastric wall will be obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. Volume will be measured in mL.|At 3 months, approximately 30 min after liquid meal|Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data||||||
2533642|NCT03261531|Secondary|Fasting Gastric Volume by 99mTc-SPECT Imaging|A noninvasive SPECT method will be used to measure gastric volume. Subjects will report to the clinic after an overnight fast. The first fasting scan will be obtained, and the study medication (99mTc) will be given subcutaneously. After 10 min, a 2nd fasting post medication scan will be obtained. Each scan requires about 9-12 min. Tomographic images of the gastric wall will be obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. Volume will be measured in mL.|At 3 months, approx 20 minutes after 99mTC injection|Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data||||||
2533643|NCT03261531|Primary|Gastric Half-emptying Time (GE T 1/2)|The time for half of the ingested solids to leave the stomach|At 3 months, approximately 2 hours after radiolabeled meal is ingested|Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data||||||
2533644|NCT03261531|Primary|Gastric Half-emptying Time (GE T 1/2)|The time for half of the ingested solids to leave the stomach|After 1 day treatment (approximately at 4 hours)|Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data||||||
2533645|NCT03261531|Primary|Change in Body Weight|Change in body weight will be measured in kilograms or pounds|Baseline, 3 months|Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data||||||
2533646|NCT03261167|Secondary|Change From Baseline in Vital Sign Parameter Temperature at Week 12 and Week 48|Vital sign parameter temperature was measured orally, intra-aurally, or axillary fossa, the participant was instructed to refrain from eating food or drinking beverage within 5 minutes before the measurement. The method for the measurement of body temperature was same throughout the study. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.|Baseline (Day 1), Week 12 and Week 48|Safety1 Population. Only those participants with data available at the indicated time point were analyzed (represented by n=X in category titles).|||Degree Celsius||Standard Deviation|Mean
2533647|NCT03261167|Secondary|Change From Baseline in Vital Sign Parameter Heart Rate at Week 12 and Week 48|Vital sign parameter heart rate was measured in a semi-recumbent position after a 5-minute rest. If measurement in a semi-recumbent position was difficult, measurement in another position (e.g., sitting) was acceptable. The measurement was performed always in the same position during the study period. Heart rate was measured using an automated device. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.|Baseline (Day 1), Week 12 and Week 48|Safety1 Population. Only those participants with data available at the indicated time point were analyzed (represented by n=X in category titles).|||Beats per minute||Standard Deviation|Mean
2533648|NCT03261167|Secondary|Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 12 and Week 48|Vital sign parameters SBP and DBP were measured in a semi-recumbent position after a 5-minute rest. If measurement in a semi-recumbent position was difficult, measurement in another position (e.g., sitting) was acceptable. The measurement was performed always in the same position during the study period. SBP and DBP were measured using an automated device. Baseline value was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value minus the Baseline value.|Baseline (Day 1), Week 12 and Week 48|Safety1 Population. Only those participants with data available at the indicated time point were analyzed (represented by n=X in category titles).|||Millimeters of mercury||Standard Deviation|Mean
2533649|NCT03261167|Secondary|Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis|Urinalysis parameters assessed were urine occult blood, urine protein . In this dipstick test, occult blood and protein in urine samples were recorded as negative trace, 1+, 2+, and 3+ (the plus sign increases with occult blood or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive etc). Number of participants with worst-case urinalysis results post-Baseline relative to Baseline by dipstick analysis have been presented.|Up to Week 48|Safety 1 Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2533783|NCT03258814|Secondary|Change From Baseline in Patient's Global Assessment of Pain|The patient's global assessment of pain was assessed on a NRS from 0 (no pain) to 10 (pain as bad as it could be).|Baseline and Month 3|Participants with available data|||scores on a scale||Standard Deviation|Mean
2533650|NCT03261167|Secondary|Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-Baseline Relative to Baseline|Clinical chemistry parameters assessed were alkaline phosphatase (100 to 325 international units/liter), alanine amino transferase (5 to 45 international units/liter), aspartate amino transferase (10 to 40 international units/liter), direct bilirubin (0 to 3.42 micromoles/liter), total bilirubin (3.42 to 20.52 micromoles/liter), calcium (2.0958 - 2.5948 millimoles/liter), creatinine (53.924 - 91.936 micromoles/liter), potassium (3.5 - 5 millimoles/liter), sodium (137 - 147 millimoles/liter), total protein (67 - 83 grams/liter), urea/blood urea nitrogen (BUN) [2.856 - 7.14 millimoles/liter]. Shift in values relative to normal range as high and low have been presented for categories having non-zero values.|Up to Week 48|Safety 1 Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2533651|NCT03261167|Secondary|Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to Baseline|Hematology parameters along with their normal ranges included: basophils (0 to 2 percent), eosinophils (0 to 8 percent), hemoglobin (135 to 175 grams/liter), hematocrit (0.397 to 0.524 proportion of red blood cells in blood), lymphocytes (18 to 49 percent), monocytes (2 to 10 percent), total neutrophils (40 to 75 percent), platelet count (140 to 340 giga cells/liter), red blood cell count (4.3 to 5.7 trillion cells/liter), white blood cell count (3.3 to 9 giga cells/liter), mean corpuscular volume (85 to 102 femtoliters), mean corpuscular hemoglobin (28 to 34 picograms) and reticulocyte count (0.004 to 0.019 percent/ratio). Shift in values relative to normal range as high and low have been presented for categories having non-zero values.|Up to Week 48|Safety1 Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2533652|NCT03261167|Secondary|Number of Participants With Abnormal Findings After Physical Examinations|Physical examinations included assessment of lungs, cardiovascular system, and abdominal region (liver and spleen). This analysis was not planned and data was not collected and captured in the database.|Up to Week 48|Safety1 Population. This analysis was not planned and data was not collected and captured in the database.||||||
2533653|NCT03261167|Secondary|Number of Participants With AEs and SAEs-Overall Study Period|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Data for number of participants with any AE and any SAE is presented.|Up to Week 48|Safety1 Population|||Participants|||Count of Participants
2533654|NCT03261167|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) After 84 Days of First Treatment|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Data for number of participants with any AE and any SAE is presented.|Up to 84 days post first treatment|Safety1 Population. Safety1 Population comprised of all participants who were randomized in the study and who receive study treatment at least once.|||Participants|||Count of Participants
2533655|NCT03261167|Secondary|Change From Baseline in Principal Therapeutic Target of Disability Assessment Scale (DAS) - MMRM up to Week 12|The investigator assessed 4 areas of disability namely hygiene, pain, dressing and limb posture and was graded using the 4-point DAS scale where (0=No functional disability, 1: Mild disability, 2: Moderate disability and 3=Severe disability). The investigator, in consultation with the participant, selected 1 functional disability item from the 4 areas of disability and assessed it as a principal therapeutic target. The maximum possible score was 3 where higher scores indicate severe disability and lowers scores indicate sound functional ability. Baseline value was defined as the latest pre-first dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Day 1), Week 2, Week 4, Week 6 and Week 12|ITT1 Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Scores on scale||Standard Error|Least Squares Mean
2533656|NCT03261167|Secondary|Change From Baseline in MAS Scores in Elbow, Wrist, Finger and Thumb Flexors up to Week 12 (Mixed Model Repeated Measures [MMRM])|The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion/extension, 1+=Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2=More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3=Considerable increase in muscle tone, passive movement difficult and 4=Affected part(s) rigid in flexion/extension. Higher scores=worst outcome while lower scores=better outcome. Baseline was defined as the latest pre-first dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Day 1), Week 2, Week 4, Week 6 and Week 12|ITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=x in the category titles).|||Scores on a scale||Standard Error|Least Squares Mean
2533666|NCT03260868|Secondary|Change From Baseline in 7-Point Self-Monitoring of Plasma Glucose (SMPG) Profiles at Week 16 and Week 24 Per Time Point|7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, Week 16, and Week 24): before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, and bedtime. For each time point, the value at each visit was calculated as the average of values obtained for the same time point across profiles performed in the week before the visit.|Baseline, Week 16, Week 24|Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.||||||
2533657|NCT03261167|Secondary|Percentage of Participants Who Had MAS Score Reduction in Elbow, Wrist, Finger and Thumb Flexors up to Week 12|MAS was used to measure the level of spasticity. The test was performed in a sitting position throughout the study. The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension, 1+=Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM, 2=More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3=Considerable increase in muscle tone, passive movement difficult and 4=Affected part(s) rigid in flexion or extension. Higher scores=worst outcome while lower scores=better outcome.|Week 2, Week 4, Week 6 and Week 12|ITT1 Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Percentage of participants|||Number
2533658|NCT03261167|Primary|Percentage of Participants Who Had Modified Ashworth Scale (MAS) Score Reduced at Least 1 From Baseline in the Elbow Flexors at Week 6|MAS was used to measure the level of spasticity. The test was performed in a sitting position throughout the study. The affected parts were extended as fast as possible to grade the flexor muscle tones. It was scored on a scale of 0 to 4 as: 0=No increase in muscle tone, 1=Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension, 1+= Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half of ROM, 2 =More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved, 3= Considerable increase in muscle tone, passive movement difficult and 4= Affected part(s) rigid in flexion or extension. Higher scores= Worst outcome while lower scores= Better outcome.|Week 6|Intent to treat 1 (ITT1) Population comprised of participants who were randomized in the study and who had at least 1 post-baseline efficacy assessment.|||Percentage of participants|||Number
2533659|NCT03260894|Secondary|Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Discontinuing Study Drug Due to AEs|AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.|Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.|The All Subjects as Treated (ASaT) population was used for the safety analysis and consisted of all randomized participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2533660|NCT03260894|Secondary|Safety and Tolerability of Pembrolizumab + Epacadostat Versus SOC as Measured by the Number of Participants Experiencing Adverse Events (AEs)|AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.|Data reported from start of study to data cutoff 28-Feb-2019, up to 15 months.|The All Subjects as Treated (ASaT) population was used for the safety analysis and consisted of all randomized participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2533661|NCT03260894|Primary|Objective Response Rate (ORR) of Pembrolizumab + Epacadostat Versus Standard of Care (SOC)|ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination.|Minimum up to 6 months|"The Intention-to-Treat (ITT) population consisted of all randomized participants.~Responses are based on Investigator assessments per RECIST 1.1 without confirmation using all scans up to the cutoff date 28FEB2019."|||percentage of participants||95% Confidence Interval|Number
2533662|NCT03260868|Secondary|Number of Participants With At Least One Hypoglycemic Events (Any, Severe Documented Symptomatic, Probable Symptomatic, Asymptomatic, Pseudo-hypoglycemia: Any Time of the Day) During 24 Week Treatment Period|Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (70 mg/dL) or <3.0 mmol/L (54 mg/dL). Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration <=3.9 mmol/L (70 mg/dL) or <3.0 mmol/L (54 mg/dL). Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia were not accompanied by plasma glucose determination but was presumably caused by a plasma glucose concentration. Pseudo-hypoglycemia: an event with any of the typical symptoms of hypoglycaemia with plasma glucose concentration >3.9 mmol/L (70 mg/dL).|During 24 weeks treatment period|Analysis was done on safety population which included all randomized participants who did actually receive at least one dose of investigational medicinal product (IMP), regardless of the amount of IMP administered.|||Participants|||Count of Participants
2533663|NCT03260868|Secondary|Overall Study Experience-Sites Questionnaire Part-2 Scores for Site-Perceived Participant Relationship and Satisfaction at Week 24|An OSES questionnaire was completed by site investigator and had two parts. OSES Part-2 contains 2 items to examine investigator-participant relationship and satisfaction with care. Both items were assessed on a scale of 0 [completely disagree] to 10 [completely agree]), where highest score indicated a good relationship and satisfaction with care.|At Week 24|Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.||||||
2533664|NCT03260868|Secondary|Overall Study Experience-Sites (OSES) Questionnaire Part-1: Hours Spent by Investigator|An OSES questionnaire was completed by Site Investigator and had 2 parts. The OSES Part-1 contained quantitative 1 item (question) to examine resource requirements which was: Approximately how much time did you spend with this participant (in person or via phone) during this scheduled visit/communication? (hours)|During 24 weeks treatment period|Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.||||||
2533665|NCT03260868|Secondary|Average Daily Insulin Doses|Average daily insulin doses included basal insulin doses, mealtime insulin doses, and total insulin doses.|During 24 weeks treatment period|Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.||||||
2533736|NCT03259425|Secondary|Complete Surgical Resection|patients will be assessed at surgery to determine if complete surgical resection was achievable after neo-adjuvant treatment with nivolumab and HF10.|Within 28 days after Day 84|||||||
2533667|NCT03260868|Secondary|Diabetes Distress Scale (DDS) Scores|Diabetes-related distress was measured using DDS. The DDS contained 17 items related to potential problem areas that people with diabetes may experience. Participants were asked to consider the degree to which each of the items might have distressed or bothered them during the past month, and respond for each item on a 7 point scale ranges from 1 (not a problem) to 6 (a very serious problem), higher score indicated more diabetes related distress.|Week 0, Week 24|Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.||||||
2533668|NCT03260868|Secondary|Hypoglycemia Fear Survey-II (HFS-II) Scores|"Fear of hypoglycemia was measured with HFS-II at Week 24. The HFS-II comprises 33 items: 15 items explore behaviors that participants were engaged in to avoid low blood sugar and its negative consequences and 18 items related to concern/worry that participants had about their hypoglycemia. Responses to each item were made on a 5-point Likert scale ranges from 0 equal (=) Never to 4 = Always. Total HFS mean score was determined by computing the mean of all 33 items and the score ranged from 0 to 4, where higher score indicated more fear/worry."|At Week 24|Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.||||||
2533669|NCT03260868|Secondary|Change From Baseline in Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) Score to Week 24|DTSQc measured the relative change in treatment satisfaction from previous therapy. It consists of 8 items that were answered on a 6 point scale ranges from 3 (much less satisfied) to -3 (much more satisfied). Total treatment satisfaction score was the sum of items 1, 4-8 scores and ranged from -18 (much less satisfied) to +18 (much more satisfied), higher score indicated more satisfaction.|Baseline, Week 24|Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.||||||
2533670|NCT03260868|Secondary|Change From Baseline in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) to Week 24|The DTSQs was a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consisted of 8 items that were answered on a Likert scale from 0 (no satisfaction) to 6 (high satisfaction with treatment). Total treatment satisfaction score was the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (high satisfaction with treatment).|Baseline, Week 24|Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.||||||
2533671|NCT03260868|Secondary|Resource Use Questionnaire (RUQ) Scores|Healthcare resource use was measured using the RUQ which asked participants to report the resources used (time and expenses) during the previous 4 weeks in terms of visits to healthcare professionals.|During 24 weeks treatment period|Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.||||||
2533672|NCT03260868|Secondary|Change From Baseline in Overall Study Experience-Participation Part-2 Questionnaire Score to Week 24|Participant burden with trial participation was measured using the OSEP Questionnaire, administered electronically. OSEP Part-2 contained 9 items to examine perceptions of study participation. Each item was measured on an 11 point scale ranged from 0 (completely disagree) to 10 (completely agree), where higher score indicated higher burden with trial participation.|Baseline, Week 24|Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.||||||
2533673|NCT03260868|Secondary|Change From Baseline in Overall Study Experience-Participation (OSEP) Part-1 Questionnaire Score to Week 24|Participant burden with trial participation was measured using the OSEP Questionnaire, administered electronically. OSEP Part-1 contained 4 items to examine perceptions of study participation. Each item was measured on an 11 point scale ranged from 0 (completely disagree) to 10 (completely agree), where higher score indicated higher perception of diabetes control.|Baseline, Week 24|Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.||||||
2533674|NCT03260868|Secondary|Change From Baseline in Work Productivity and Impairment-Study Participation (WPAI-SP) Scores to Week 24|Effect of trial on a participants' ability to work and perform regular activities were measured using WPAI-SP. WPAI-SP had 6 items scored separately, where higher score indicated greater impairment and less productivity.|Baseline, Week 24|Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.||||||
2533675|NCT03260868|Secondary|Participant Satisfaction With Trial Experience: Was It Worth It (WIWI) Questionnaire Response at Week 24|Participant satisfaction with trial experience was measured using the WIWI questionnaire. The WIWI had 5 questions, 3 questions with level categorical response (Yes, No, and Unsure) scale, 1 question with 3 possible answers as: Better than I expected/The same as I expected/Worse than I expected, and 1 question with 3 possible answers: It improved/Stayed the same/Become worse.|At Week 24|Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.||||||
2533676|NCT03260868|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) to Week 16 and Week 24|Change in FPG was calculated by subtracting baseline value from Week 16 value (for change at Week 16) and Week 24 (for change at Week 24) value.|Baseline, Week 16, Week 24|Analysis was performed on ITT population. Here, “number analyzed” signifies participants with available data for each time point.|||millimole per liter (mmol/L)||Standard Deviation|Mean
2533677|NCT03260868|Secondary|Change From Baseline in Glycated Hemoglobin A1c to Week 16|Change in HbA1c was calculated by subtracting baseline value from Week 16 value.|Baseline, Week 16|Analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ signifies participants with available data for the outcome measure.|||percentage of HbA1c||Standard Deviation|Mean
2533678|NCT03260868|Primary|Change From Baseline in Glycated Hemoglobin A1c (HbA1c) to Week 24|Change in HbA1c was calculated by subtracting baseline value from Week 24 value.|Baseline, Week 24|Analysis was performed on intent to treat (ITT) population which included all randomized participants, irrespective of the trial approach group actually being used, analyzed according to the approach group allocated by randomization. Here, “overall number of participants analyzed” signifies participants with available data for the outcome measure.|||percentage of HbA1c||Standard Deviation|Mean
2533679|NCT03260699|Secondary|Amount of Pain Medication Used|Investigators will monitor the medical record for the amount of pain medication used|Change from baseline to 12 weeks after surgery||||morphine equivalents/day||Standard Deviation|Mean
2533680|NCT03260699|Secondary|Type of Pain Medication Used|Investigators will monitor the medical record for types of pain medications used.|Change from baseline to 12 weeks after surgery||||Participants|||Count of Participants
2533681|NCT03260699|Secondary|Hospital for Special Surgery (HSS) Score (0-100 Scale)|Clinical outcome assessment tool. It is based on a total of 100 points. The score is divided into seven categories, which include pain, function, range of motion, muscle strength, flexion deformity, instability, and subtractions. The knee is initially given a score of 0, and additions or subtractions are made according to specific criteria. The higher the score, the better the outcome. Approximately 50% of the score is based on a patient interview and the remaining on physical exam.|Change from baseline to 12 weeks after surgery||||units on a scale||Full Range|Mean
2533682|NCT03260699|Secondary|Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.) Questionnaires|Clinical outcome questionnaire that measure joint-specific pain and physical function. It has seven questions that focus on three categories: joint pain, stiffness, and function, in daily living. Raw scores are added up (range 0-28) and converted to an interval score (0-100) using an interval table. The interval score represents a patients total joint disability where 0 corresponds to total joint disability and 100 perfect joint health.|Change from baseline to 12 weeks after surgery||||units on a scale||Full Range|Mean
2533683|NCT03260699|Secondary|Knee Society Score Questionnaire|"Clinical outcome questionnaire developed by the consensus of the Knee Society. It comprises, a Knee score and a Functional score. The Knee score assesses pain, stability, and range of motion. A maximum score of 100 is achieved by a painless, well-aligned knee with 125° range of motion, with neither anteroposterior nor mediolateral instability. Deductions are made for flexion contracture, extension lag, and malalignment. The Functional score assesses walking distance and stair climbing. A maximum score of 100 is assigned to individuals who can walk unlimited distances and can climb up and down stairs normally. Deductions are made for use of a walking stick or crutches. Therefore, higher scores correlate with better function and outcome."|Change from baseline to 12 weeks after surgery||||units on a scale||Full Range|Mean
2533684|NCT03260699|Secondary|6 Minute Walk Test (Distance Measurement)|Used to assess a person's endurance and aerobic capacity. The score of the test is distance a patient walks in 6 minutes. Longer distances walked by the patient in 6 minutes correlates with better performance. Distance is measured using distance measuring wheel.|Change from baseline to 12 weeks after surgery||||meters||Full Range|Mean
2533685|NCT03260699|Secondary|One-leg Stance Time (Timed Measurement)|Used to assess a person's balance. Performed with eyes open and arms on hips. The patient is asked to stand unassisted on one leg and is timed in seconds (using stopwatch) from the time one foot is flexed off the floor to the time when it touches the ground or the standing leg or an arm leaves the hips.|Change from baseline to 12 weeks after surgery||||seconds||Full Range|Mean
2533686|NCT03260699|Secondary|Timed Stair Climb (Timed Measurement Over Fixed Distance)|Used to assess a person's mobility and balance|Change from baseline to 12 weeks after surgery||||seconds||Full Range|Mean
2533687|NCT03260699|Secondary|Timed up and go Test (Timed Measurement)|Used to assess a person's mobility and balance. It is measured in time units (seconds or minutes) using a stopwatch by a study personnel. To perform, the patient sits back in a standard arm chair and a line 3 meters, or 10 feet away on the floor is identified. At the investigator mark, the stopwatch is started and the patient is asked to stand up from chair, walk to the end of the line and come back to his chair at normal pace. The results is the time in seconds needed for the patient to perform the test (getting up from chair and coming back to it as timed by the investigator's stopwatch)|Change from baseline to 12 weeks after surgery||||Seconds||Full Range|Mean
2533688|NCT03260699|Secondary|Visual Analog Scale (VAS) for Pain (0-10 Scale)|Visual Analog Scale is a a pain scale assessment instrument that has been widely used to allow adult patients to report their pain level in musculoskeletal research studies. It is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, anchored by 2 two ends representing the extremes of measurements with 0 point representing no pain and 10 representing the worst pain a patient may have had. Therefore, starting from zero point, increasing numbers demonstrate worse pain. Patient can pick a point on the scale that they believe represent their pain level at a given moment.|Change from baseline to 12 weeks after surgery||||units on a scale||Full Range|Mean
2533689|NCT03260699|Primary|Number of Physical Therapy Visits|Investigators will monitor the total number of physical therapy visits that was necessary to return to normal function between the control and bracing group and how it relates to overall cost.|Total number of visits from date of surgery to 12 weeks after surgery||||visit||Full Range|Mean
2533690|NCT03260595|Secondary|Cohort 2: Accumulation Ratio for AUCtau (Rac [AUCtau]) of Crisaborole and Its Identified Main Oxidative Metabolites|AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 8 divided by AUCtau on Day 1. Dosing interval = 12 hours.|Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and 8|PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2533691|NCT03260595|Secondary|Cohort 2: Accumulation Ratio for Cmax (Rac [Cmax]) of Crisaborole and Its Identified Main Oxidative Metabolites|AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. Accumulation ratio for Cmax (Rac, Cmax) was calculated as Cmax on Day 8 divided by Cmax on Day 1. Cmax was the maximum plasma concentration of Crisaborole and its identified main oxidative metabolites.|Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and 8|PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2533692|NCT03260595|Secondary|Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Tau (12 Hours Dosing Interval) (AUCtau) of Crisaborole and Its Identified Main Oxidative Metabolites|AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole. AUC tau was defined as area under the plasma concentration-time curve from time 0 to time tau, the dosing interval, where tau =12 hours.|Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8|PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2533693|NCT03260595|Secondary|Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero to the 24 Hours Post-Dose (AUC24) of Crisaborole and Its Identified Main Oxidative Metabolites (AN7602 and AN8323)|AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.|Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8|PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2533694|NCT03260595|Secondary|Cohort 2: Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Measurable Concentration (AUClast) of Crisaborole and Its Identified Main Oxidative Metabolites|AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.|Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8|PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.|||hours*nanograms per milliliter(hr*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2533695|NCT03260595|Secondary|Cohort 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crisaborole and Its Metabolites|AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.|Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8|PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.|||hours||Full Range|Median
2533696|NCT03260595|Secondary|Cohort 2: Maximum Observed Plasma Concentration (Cmax) of Crisaborole and Its Identified Main Oxidative Metabolites|AN7602 and AN8323 were the main identified oxidative metabolites of Crisaborole.|Pre-dose, 3, 12 and 24 hours post-dose on Day 1 and Day 8|PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of primary interest. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2533697|NCT03260595|Secondary|Cohort 1: Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose of study drug (up to Day 29) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious AEs.|Baseline up to Day 29|Safety analysis population included all participants who received at least one dose of study medication.|||Participants|||Count of Participants
2533698|NCT03260595|Primary|Cohort 2: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities|Criteria for clinically significant ECG abnormalities included: QT interval >=500 milliseconds (msec); QT interval corrected using the Fridericia's formula (QTcF) >=450 msec to <480 msec, >=480 msec and >=500 msec; increase from baseline in QTcF interval >=30 msec to <60 msec and >=60 msec.|Baseline up to end of treatment (Day 8)|Safety analysis population included all participants who received at least one dose of study medication. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.|||Participants|||Count of Participants
2533699|NCT03260595|Primary|Cohort 2: Number of Participants With Laboratory Tests Abnormalities|Laboratory tests abnormalities included: hematology (haemoglobin[Hb], haematocrit and erythrocytes<0.8*lower limit of normal[LLN]; erythrocyte mean corpuscular volume, erythrocyte mean corpuscular Hb and erythrocyte mean corpuscular Hb concentration <0.9*LLN and >1.1*upper limit of normal[ULN]; platelets <0.5*LLN and >1.75*ULN; leukocytes <0.6*LLN and >1.5*ULN; lymphocytes/leukocytes[%], neutrophils/leukocytes[%] <0.8*LLN and >1.2*ULN; basophils/leukocytes[%], eosinophils/leukocytes[%], monocytes/leukocytes[% ]>1.2*ULN); clinical chemistry(bilirubin>1.5*ULN; aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase>3.0*ULN; protein and albumin<0.8*LLN and >1.2*ULN; urea nitrogen and creatinine >1.3*ULN; urate>1.2*ULN; sodium <0.95*LLN and >1.05*ULN; potassium, chloride and calcium <0.9*LLN and >1.1*ULN; fasting glucose <0.6*LLN and >1.5*ULN); and urinalysis (pH <4.5 and >8; glucose, ketones, protein, Hb, urobilinogen, bilirubin, nitrite and leukocyte esterase >=1).|Baseline up to end of treatment (Day 8)|Safety analysis population included all participants who received at least one dose of study medication. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.|||Participants|||Count of Participants
2533700|NCT03260595|Primary|Cohort 2: Number of Participants With Clinically Significant Vital Signs Abnormalities|Vital signs included pulse rate and blood pressure. Clinical significance of vital signs was determined at the investigator's discretion.|Baseline up to end of treatment (Day 8)|Safety analysis population included all participants who received at least one dose of study medication. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1, as pre-specified in protocol.|||Participants|||Count of Participants
2533701|NCT03260595|Primary|Cohort 2: Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose of study drug (up to Day 36) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious AEs.|Baseline up to Day 36|Safety analysis population included all participants who received at least one dose of study medication.|||Participants|||Count of Participants
2533737|NCT03259425|Secondary|Overall Survival|patients will be followed for survival for one year after completion of adjuvant nivolumab|2 years (1 year after stopping 1 year of Nivolumab)|||||||
2533738|NCT03259425|Secondary|Recurrence-free Survival|Recurrence after surgery will be assessed by radiologic scans scheduled per section 8 and confirmed by biopsy.|1 year post surgery|||||||
2533702|NCT03260595|Primary|Cohort 1: Skin Irritation Index|The skin irritation index is a common measure of skin irritation potential (safety criteria) of investigational product and derived using skin irritation scores. Individual skin irritation score ranges from 0-4, where 0 = no reaction, 0.5 = mild erythema, 1 = erythema, 2 = erythema with edema and papula, 3 = erythema with edema, papula and small water blister, 4 = large water blister, higher score indicates more skin irritation. For each investigational product, the skin irritation index was calculated as the sum of the maximum individual skin irritation scores divided by the number of evaluable participants and multiplied by 100, which ranged from 0 to 400; where, lower score indicated less skin irritation and higher score indicated more skin irritation.|Day 3 to 4|Safety analysis population included all participants who received at least one dose of study medication. Data for this outcome measure was not planned to be collected and analyzed for Cohort 2, as pre-specified in protocol.|||scores on a scale|||Number
2533703|NCT03260426|Secondary|Bloating Score|"Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome.~Bloating Score on POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome."|POD 1 and POD 2 and Discharge|All participants undergoing surgery.|||score on a scale||Full Range|Mean
2533704|NCT03260426|Secondary|Nausea Score|"Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome.~Nausea Score on POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome."|POD 1 and POD 2 and Discharge|All participants undergoing surgery.|||score on a scale||Full Range|Mean
2533705|NCT03260426|Secondary|Pain Score|"Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome.~Pain score evaluated POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome."|POD 1 and POD 2 and Discharge|All participants undergoing surgery|||score on a scale||Full Range|Mean
2533706|NCT03260426|Secondary|Post-operative Ileus|Development of post-operative ileus|30 days|All participants undergoing surgery|||Participants|||Count of Participants
2533707|NCT03260426|Secondary|Hospital Stay|Length of postoperative stay|30 days||||days||Standard Error|Mean
2533708|NCT03260426|Secondary|Antiemetic Usage|If antiemetics were used in|30 days|All participants undergoing surgery|||Participants|||Count of Participants
2533709|NCT03260426|Secondary|Number of Participants Able to Tolerate a Regular Diet as Compared to a Clear Liquid Diet on Post Operative Day 0 (POD 0).|Tolerability of regular diet will be determined by the patients ability to eat more than 50% of a solid meal on post operative day zero.|POD 0|All participants undergoing surgery|||Participants|||Count of Participants
2533710|NCT03260426|Primary|Number of Participants Who Experienced Emesis on Post Operative Day 2|Patient tolerability, as evidenced by development of vomiting on postoperative day two.|POD 2|All participants undergoing surgery|||Participants|||Count of Participants
2533711|NCT03260205|Secondary|Number of Participants With a Positive Response Using Columbia Suicide Severity Rating Scale (C-SSRS)|C-SSRS was semi-structured interview that captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview included definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. The C-SSRS contained 2 required items pertaining to suicidal ideation, 4 required items pertaining to suicidal behavior, and 1 required item pertaining to non-suicidal but self-injurious behavior. In situations where there was a positive response to the screening questions, there were 8 additional suicidal ideation items and 4 additional suicidal behavior items which were completed. Thus, there was a maximum of 19 items to be completed. Here number of participants responded as yes to suicidal ideation or behaviour were reported.|Up to Week 6|Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Participants|||Number
2533712|NCT03260205|Secondary|Children's Sleep Habits Questionnaire (CSHQ) at Week 6|Children's Sleep Habits Questionnaire was a tool designed to screen the most common sleep problems in children, and consisted of 33 items for scoring. The instrument evaluated the child's sleep based on behavior within 8 different subscales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night walkings, parasomnias, sleep-disordered breathing, and daytime sleepiness. Each item receives a score from 1 (problem occurs rarely) to 3 (problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: bedtime resistance: 6 to 18, sleep onset delay: 1 to 3, sleep duration: 3 to 9, sleep anxiety: 4 to 12, night walkings: 3 to 9, parasomnias: 7 to 21, sleep-disordered breathing: 3 to 9, daytime sleepiness: 8 to 24, and total disturbance (items from all scales): 33 to 99.|Week 6|Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure at the specific categories.|||Score on scale||Standard Deviation|Mean
2533713|NCT03260205|Secondary|Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters|Number of participants with potentially clinically significant changes in ECG parameters were reported. QTcF interval represents QT Fridericia's Correction Formula interval, QTcB interval represents QTc corrected by Bazett's in measure data.|Week 6|Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and at the specific categories.|||Participants|||Count of Participants
2533714|NCT03260205|Secondary|Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Values|Clinical laboratory evaluations included biochemistry and endocrinology, hematology, and urinalysis. Number of participants with potentially clinically significant changes in clinical laboratory values were reported. ULN in measure data represents upper limit of normal, mcmol/L represents to Micromoles Per Litre, > = represents greater than or equal to.|Week 6|Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and at the specific categories.|||Participants|||Count of Participants
2533715|NCT03260205|Secondary|Change From Baseline in Body Mass Index (BMI) at Week 6|BMI was derived from height and weight. BMI percentile was normalized by sex and age using the CDC growth charts. BMI percentiles were categorized as: Underweight (BMI < 5th percentile); Healthy weight (BMI 5th percentile up to < 85th percentile); Overweight (BMI 85th percentile < 95th percentile); Obese (BMI >= 95th percentile). Change from baseline in body mass index at Week 6 was reported.|Baseline, Week 6|Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||BMI percentile||Standard Deviation|Mean
2533716|NCT03260205|Secondary|Change From Baseline in Body Weight at Week 6|Body weight was measured in percentile without shoes. Body weight percentile was normalized by sex and age using the Centers for Disease Control and Prevention (CDC) growth charts. Body weight percentiles were categorized as lesser than (<) 5th, 5th to < 95th, and greater than or equal to (>=) 95th percentiles. Change from baseline in body weight at Week 6 was reported.|Baseline, Week 6|Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Weight percentile||Standard Deviation|Mean
2533717|NCT03260205|Secondary|Change From Baseline in Height at Week 6|Height was measured in inche without shoes, with the participant stood on a flat surface and with chin parallel to the floor.|Baseline, Week 6|Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Centimeter||Standard Deviation|Mean
2533718|NCT03260205|Secondary|Number of Participants With Potentially Clinically Significant Changes in Vital Signs|Vital sign assessments included blood pressure (systolic and diastolic), average pulse rate. Number of participants with potentially clinically significant changes in vital signs were reported. mmHg represents millimetre of mercury in the outcome measure data.|Week 6|Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2533719|NCT03260205|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a investigational product (IP) and that does not necessarily had a causal relationship with this treatment. TEAEs were defined as AEs that start or deteriorate on or after the date of the first dose of IP and no later than 3 days following the last dose of IP.|From start of study drug administration up to follow-up (Week 7)|Safety analysis set consisted of all randomized set who had taken at least 1 dose of investigational product.|||Participants|||Count of Participants
2533720|NCT03260205|Secondary|Dose Response Relationship for Change From Baseline in ADHD-RS-IV Preschool Version Total Score in Preschool Children at Week 6|Dose response relationship was evaluated by using the ADHD-RS Preschool Version Total Score. ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that requires the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Dose response analysis set consisted of all participants in the safety analysis set who had at least 1 valid primary efficacy measurement on the randomized target dose level of the investigational product.|Baseline, Week 6|Dose response analysis set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Each SPD489 arm is compared with placebo sequentially, with the highest dose level first.|||Score on a scale||Standard Error|Mean
2533721|NCT03260205|Secondary|Clinical Global Impressions Global Improvement (CGI-I) at Week 6|CGI-I was an overall assessment of global symptom improvement by evaluation of the participant's condition severity and improvement over time. Scoring was done based on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), where higher score reported worse condition. The scoring was elaborated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. FAS consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment.|Week 6|Full analysis set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. This outcome was pre-specified to collect and analyze pooled groups of SPD489 doses. The data were planned, analyzed, and reported only for the placebo and the pooled 10, 20, 30 mg doses of SPD489 arms.|||Score on a scale||Standard Error|Mean
2533722|NCT03260205|Primary|Change From Baseline in Clinician-Administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version Total Score at Week 6|ADHD-RS-IV Preschool Version was adapted from the ADHD Rating Scale-IV and provided examples appropriate for the developmental level of preschool children. The ADHD-RS-IV Preschool Version was an 18-item questionnaire that required the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items were grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Full analysis set (FAS) consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD RS IV preschool version total score assessment.|Baseline, Week 6|Full analysis set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. This outcome was pre-specified to collect and analyze pooled groups of SPD489 doses. The data were planned, analyzed, and reported only for the placebo and the pooled 10, 20, 30 mg doses of SPD489 arms.|||Score on a scale||Standard Error|Mean
2533781|NCT03258814|Secondary|Change From Baseline in Patient's Assessment of Nocturnal Back Pain|The patient's assessment of nocturnal back pain was assessed on a NRS from 0 (no pain) to 10 (most severe pain).|Baseline and Month 3|Participants with available data|||scores on a scale||Standard Deviation|Mean
2539139|NCT03079375|Primary|Composite Endpoint, Admissions or Emergency Department Visits|number of patients who experience primary composite endpoint, admissions or emergency department visits within 6 month|180 days||||Participants|||Count of Participants
2533723|NCT03259555|Secondary|Change From Baseline In Clinical Global Impression-Bipolar (CGI-BP) Severity Score In Mania At Week 3|The CGI-BP scale refers to the global impression of the participant with respect to bipolar disorder. The scale rates the participant's severity of illness (CGI-BP severity of illness: mania, depression, and overall bipolar illness) based on a 7-point scale: 1 = normal, not at all ill, 2 = minimally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = very severely ill.|Baseline, Week 3|Full Analysis Set: all participants who received at least 1 dose of study drug and had a baseline value and at least 1 valid post-randomization efficacy evaluation for YMRS Total Score in the double-blind treatment phase at the specified timepoint.|||units on a scale||Standard Deviation|Mean
2533724|NCT03259555|Primary|Change From Baseline In Young-Mania Rating Scale (YMRS) Score At Week 3|"The YMRS was utilized to assess a participant's level of manic symptoms. It consists of 11 items: 1) elevated mood, 2) increased motor activity-energy, 3) sexual interest, 4) sleep, 5) irritability, 6) speech (rate and amount), 7) language-thought disorder, 8) content, 9) disruptive-aggressive behavior, 10) appearance, and 11) insight. Seven items are rated on a 0- to 4-scale, while four items (Items 5, 6, 8, and 9) are rated on a 0- to 8-scale with 0, 2, 4, 6, and 8 being the possible scores (twice the weight of the other items). For all items, 0 is the best rating and the highest score (4 or 8) is the 'worst' rating. The YMRS total score is the sum of ratings for all 11 items; therefore, possible total scores range from 0 to 60, with higher scores signifying more severe manic symptoms. Comparison between treatment groups was carried out using mixed-effect model repeated measure (MMRM)."|Baseline, Week 3|Full Analysis Set: all participants who received at least 1 dose of study drug and had a baseline value and at least 1 valid post-randomization efficacy evaluation for YMRS Total Score in the double-blind treatment phase at the specified timepoint.|||units on a scale||Standard Error|Least Squares Mean
2533725|NCT03259490|Secondary|AUC(0-∞) for Linagliptin|AUC(0-∞) for Linagliptin|Pharmacokinetic samples were collected at 1:30 hours: minutes pre dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 hours:minutes post dose|PKS|||nmol*h/L||Standard Error|Geometric Mean
2533726|NCT03259490|Secondary|AUC(0-∞) for Metformin|AUC(0-∞) for Metformin|Pharmacokinetic samples were collected at 1:30 hours: minutes pre dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 hours:minutes post dose|PKS|||ng*h/mL||Standard Error|Geometric Mean
2533727|NCT03259490|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) for Empagliflozin (AUC(0-∞)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Empagliflozin (AUC(0-∞)|Pharmacokinetic samples were collected at 1:30 hours: minutes pre dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 hours:minutes post dose|PKS|||nmol*h/L||Standard Error|Geometric Mean
2533728|NCT03259490|Primary|Cmax for Linagliptin in Plasma|Cmax for linagliptin in plasma.|Pharmacokinetic samples were collected at 1:30 hours: minutes pre dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 hours:minutes post dose|PKS|||nmol/L||Standard Error|Geometric Mean
2533729|NCT03259490|Primary|Cmax for Metformin in Plasma|Cmax for metformin in plasma.|Pharmacokinetic samples were collected at 1:30 hours: minutes pre dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 hours:minutes post dose|PKS|||ng/mL||Standard Error|Geometric Mean
2533730|NCT03259490|Primary|Maximum Measured Concentration of the Empagliflozin in Plasma (Cmax)|Maximum measured concentration of the empagliflozin in plasma (Cmax)|Pharmacokinetic samples were collected at 1:30 hours: minutes pre dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 hours:minutes post dose|PKS|||nmol/L||Standard Error|Geometric Mean
2533731|NCT03259490|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72) for Linagliptin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours (AUC0-72) for Linagliptin|Pharmacokinetic samples were collected at 1:30 hours: minutes pre dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 hours:minutes post dose|PKS|||nmol*h/L||Standard Error|Geometric Mean
2533732|NCT03259490|Primary|AUC0-tz for Metformin.|AUC0-tz for metformin.|Pharmacokinetic samples were collected at 1:30 hours: minutes pre dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 hours:minutes post dose|PKS|||nanogram*hours/ millilitres (ng*h/mL)||Standard Error|Geometric Mean
2533733|NCT03259490|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) for Empagliflozin|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) for empagliflozin.~Plasma concentrations and/or parameters of a subject were to be considered as non-evaluable,if for example:~The subject experienced emesis that occurred at or before 2 times median tmax of the respective treatment (median tmax was to be determined excluding the subjects experiencing emesis)~A predose concentration was >5% Cmax value of that subject~Missing samples/concentration data at important phases of pharmacokinetic (PK) disposition curve.~Pharmacokinetic parameter set (PKS): This subject set included all subjects in the treated set (TS) who provided at least one primary or secondary PK parameter that was not excluded according to the description above. Thus, a subject was to be included in the PKS even if he/she contributed only one PK parameter value for one period to the statistical assessment."|Pharmacokinetic samples were collected at 1:30 hours: minutes pre dose and 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 hours:minutes post dose|PKS|||nanomoles*hours/ litres (nmol*h/L)||Standard Error|Geometric Mean
2533734|NCT03259425|Secondary|Radiographic Response Per RECIST 1.1|Patients will be assessed radiographically with CT or MRI scan or assessed clinically.|12 weeks from baseline to surgery|||||||
2533735|NCT03259425|Secondary|Rate of Adverse Events for Patients While Taking Nivolumab and HF10|patients will be monitored for adverse events related to nivolumab and HF10 using CTCAE criteria|Patient safety will be evaluated throughout the treatment period and follow up (Treatment with HF10 is expected to last for 84 days, treatment with nivolumab is expected to last 1 year for each patient after surgery and follow up for 1 year|||||||
2533739|NCT03259425|Primary|Pathological Response|Following 12 weeks of neoadjuvant treatment with nivolumab and HF10, patients underwent definitive surgery. A percent viable tumor was assessed semi-quantitatively in the definitive surgical resection specimen by estimating the proportion of residual tumor in relation to the total tumor area and reported as percentage viability. A pathologic complete response was defined as no viable residual melanoma cells in the surgical specimen. A major pathologic response was defined as <50% viable tumor cells. A minor pathologic response was defined as 50% or greater viable tumor cells, including specimens that had 100% viability at surgery.|12 weeks|One of seven patients had progressive disease while receiving neoadjuvant therapy and did not receive surgical resection and therefore per protocol was not assessed for response.|||Participants|||Count of Participants
2533740|NCT03259087|Secondary|Number of Participants Discontinuing the Study Due to an Adverse Event|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||Participants|||Count of Participants
2533741|NCT03259087|Secondary|Number of Participants With at Least One Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Part 1: up to Day 14 after dosing; Part 2, Period 1: up to Day 14 after dosing (including ≥6 day washout period); Part 2, Period 2: up to Day 14 after dosing|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||Participants|||Count of Participants
2533742|NCT03259087|Secondary|Part 2: Hemodialysis Clearance of MK-3866 Based on the Dialysate(CLD,Dialysate)|Plasma dialysis samples were collected at pre-specified time points and CLD,dialysate was assessed. CLD,dialysate was calculated as AD.total / AUCD. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.|0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2533743|NCT03259087|Secondary|Part 2: Cumulative Amount of MK-3866 Recovered From the Dialysate (AD,Total)|Plasma dialysis samples were collected at pre-specified time points and AD,total was assessed. AD,total was obtained by integrating the rr versus time profile over the dialysis session duration, using actual times relative to the start time of dialysis. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.|0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).|||mg||Geometric Coefficient of Variation|Geometric Mean
2533744|NCT03259087|Secondary|Part 2: Rate of Removal of MK-3866 From the Dialysate (rr)|Plasma dialysis samples were collected at pre-specified time points and rr was assessed. rr was calculated as CD x dialysate flow rate. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.|0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).|||mg/hr||Geometric Coefficient of Variation|Geometric Mean
2533745|NCT03259087|Secondary|Part 2: Amount of MK-3866 Recovered From Each Dialysate Sample (AD)|Plasma dialysis samples were collected at pre-specified time points and AD was assessed. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.|0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).|||mg||Geometric Coefficient of Variation|Geometric Mean
2533746|NCT03259087|Secondary|Part 2: Concentration of MK-3866 in Dialysate Samples (CD)|Plasma dialysis samples were collected at pre-specified time points and CD was assessed. Concentrations of MK-3866 were determined using HPLC-MS/MS.|0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).|||µM||Standard Deviation|Mean
2533747|NCT03259087|Secondary|Part 2: Dialysis Clearance of MK-3866 Based on Plasma (CLD,Plasma)|Plasma dialysis samples were collected at pre-specified time points and CLD was assessed. CLD was calculated as Q x R x (AUC[1-4.5]Ca - AUC[1-4.5]Cv) / AUC[1-4.5]Ca, where Q is the flow rate of blood through the dialyzer, and R is the ratio of blood drug concentration to plasma drug concentration. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.|0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2533782|NCT03258814|Secondary|Change From Baseline in Patient's Assessment of Total Back Pain|The patient's assessment of total back pain was assessed on a NRS from 0 (no pain) to 10 (most severe pain).|Baseline and Month 3|Participants with available data|||scores on a scale||Standard Deviation|Mean
2533748|NCT03259087|Secondary|Part 2: Area Under the Concentration-time Curve of MK-3866 in Plasma Entering the Dialyzer Line From 0.75 to 4.5 Hours During the Dialysis Period (AUC[0.75-4.5]Cv)|Plasma samples entering the dialyzer line were collected at pre-specified time points and AUC[0.75-4.5]Cv was assessed. AUC[0.75-4.5]Cv values were determined from the Cv versus time profile from 0.75 to 4.5 hours during the HD period, using the 'linear up, log down' calculation method. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.|0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).|||µM*hr||Geometric Coefficient of Variation|Geometric Mean
2533749|NCT03259087|Secondary|Part 2: Area Under the Concentration-time Curve of MK-3866 in Plasma Entering the Dialyzer Line From 0.75 to 4.5 Hours During the Dialysis Period (AUC[0.75-4.5]Ca)|Plasma samples entering the dialyzer line were collected at pre-specified time points and AUC[0.75-4.5]Ca was assessed. AUC[0.75-4.5]Ca values were determined from the Ca versus time profile from 0.75 to 4.5 hours during the HD period, using the 'linear up, log down' calculation method. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.|0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).|||µM*hr||Geometric Coefficient of Variation|Geometric Mean
2533750|NCT03259087|Secondary|Part 2: Area Under the Concentration-time Curve of MK-3866 in Plasma Entering the Dialyzer Line During the Dialysis Period (AUCD)|Plasma samples entering the dialyzer line were collected at pre-specified time points and AUCD was assessed. AUCD values were determined from the Ca versus time profile during the HD period, using the 'linear up, log down' calculation method. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.|0.5 (beginning of HD), 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).|||µM*hr||Geometric Coefficient of Variation|Geometric Mean
2533751|NCT03259087|Secondary|Part 2: Concentration of MK-3866 in Plasma Exiting the Dialyzer Line (Cv)|Plasma samples exiting the dialyzer line were collected at pre-specified time points and Cv was assessed. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.|0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).|||µM||Geometric Coefficient of Variation|Geometric Mean
2533752|NCT03259087|Secondary|Part 2: Concentration of MK-3866 in Plasma Entering the Dialyzer Line (Ca)|Plasma samples entering the dialyzer line were collected at pre-specified time points and Ca was assessed. Concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.|0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours after dosing on Day 1 of Period 2|All participants who received MK-3866 infusion and provided samples for the outcome. This outcome applied only to ESRD participants receiving HD after infusion of MK-3866 (Part 2, Period 2).|||µM||Geometric Coefficient of Variation|Geometric Mean
2533753|NCT03259087|Secondary|Part 2: Fraction of MK-3866 Excretion (Urine) During Each Collection Interval (Fe0-24)|Urine samples were collected at pre-specified intervals and Fe0-24 was assessed. Fe0-24 was obtained by dividing the amount of MK-3866 excreted in each collection interval by the dose. Urine concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.|Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1 of Period 1 and Period 2|All participants who received MK-3866 infusion and provided samples for the outcome. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||Fraction of MK-3866 Excreted||Geometric Coefficient of Variation|Geometric Mean
2533754|NCT03259087|Secondary|Part 2: Renal Clearance (CLr) of MK-3866|"Urine samples were collected at pre-specified intervals and CLr was assessed. CLr was calculated as AE(t'-t)/AUC(t'-t), where t'-t is the longest interval of time during which AE and AUC are both obtained. Urine concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV."|Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1 of Period 1 and Period 2|All participants who received MK-3866 infusion and provided samples for the outcome. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2533755|NCT03259087|Secondary|Part 2: Total Amount of MK-3866 Excreted Unchanged in the Urine Over the Period of 24 Hours (Ae0-24)|Urine samples were collected at pre-specified intervals and Ae0-24 was assessed. Ae0-24 was obtained by adding the amounts excreted over each collection interval. Urine concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.|Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1 of Period 1 and Period 2|All participants who received MK-3866 infusion and provided samples for the outcome. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||mg||Geometric Coefficient of Variation|Geometric Mean
2533756|NCT03259087|Secondary|Part 1: Fraction of MK-3866 Excretion (Urine) During Each Collection Interval (Fe0-24)|Urine samples were collected at pre-specified intervals and Fe0-24 was assessed. Fe0-24 was obtained by dividing the amount of MK-3866 excreted in each collection interval by the dose. Urine concentrations of MK-3866 were determined using HPLC-MS/MS.|Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||Fraction of MK-3866 Excreted||95% Confidence Interval|Geometric Least Squares Mean
2533757|NCT03259087|Secondary|Part 1: Renal Clearance (CLr) of MK-3866|"Urine samples were collected at pre-specified intervals and CLr was assessed. CLr was calculated as AE(t'-t)/AUC(t'-t), where t'-t is the longest interval of time during which AE and AUC are both obtained. Urine concentrations of MK-3866 were determined using HPLC-MS/MS."|Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||L/hr||95% Confidence Interval|Geometric Least Squares Mean
2533758|NCT03259087|Secondary|Part 1: Total Amount of MK-3866 Excreted in the Urine Over 24 Hours (Ae0-24)|Urine samples were collected at pre-specified intervals and Ae0-24 was assessed. Ae0-24 was obtained by adding the amounts excreted over each collection interval. Urine concentrations of MK-3866 were determined using HPLC-MS/MS.|Predose and 0-4, 4-8, 8-12, and 12-24 hours after dosing on Day 1|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||mg||95% Confidence Interval|Geometric Least Squares Mean
2533759|NCT03259087|Primary|Part 2: Vz of Plasma MK-3866|Plasma samples were collected at pre-specified time points and Vz was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1. Method of dispersion used for these data is geometric %CV.|Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||Liters||Geometric Coefficient of Variation|Geometric Mean
2533760|NCT03259087|Primary|Part 2: t1/2 of Plasma MK-3866|Plasma samples were collected at pre-specified time points and t1/2 was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1. Method of dispersion used for these data is geometric %CV.|Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||Hours||Geometric Coefficient of Variation|Geometric Mean
2533761|NCT03259087|Primary|Part 2: Tmax of Plasma MK-3866|Plasma samples were collected at pre-specified time points and Tmax was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.|Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||Hours||Full Range|Median
2533762|NCT03259087|Primary|Part 2: CL of Plasma MK-3866|Plasma samples were collected at pre-specified time points and CL was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.|Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||L/hr||95% Confidence Interval|Geometric Mean
2533763|NCT03259087|Primary|Part 2: Cmax of Plasma MK-3866|Plasma samples were collected at pre-specified time points and Cmax was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.|Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||µM||95% Confidence Interval|Geometric Least Squares Mean
2533764|NCT03259087|Primary|Part 2: Ceoi of Plasma MK-3866|Plasma samples were collected at pre-specified time points and Ceoi was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.|At the end of the infusion (0.5 hours after infusion start) on Day 1 of Period 1 and Period 2|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||µM||95% Confidence Interval|Geometric Least Squares Mean
2533765|NCT03259087|Primary|Part 2: AUC0-24 of Plasma MK-3866|Plasma samples were collected at pre-specified time points and AUC0-24 was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.|Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, and 24 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2533766|NCT03259087|Primary|Part 2: AUC0-last of Plasma MK-3866|Plasma samples were collected at pre-specified time points and AUC0-last was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.|Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2533767|NCT03259087|Primary|Part 2: AUC0-inf of Plasma MK-3866|Plasma samples were collected at pre-specified time points and AUC0-inf was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. For ESRD participants, hemodialysis took place predose in Period 1 and from 0.5 to 4.5 hours after dosing in Period 2. Data for healthy participants are from Part 1.|Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours after dosing on Day 1 of Period 1 and 2, and 2.5, 3.5, and 4 hours after dosing on Day 1 of Period 2|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2533768|NCT03259087|Primary|Part 1: Volume of Distribution of Plasma MK-3866 (Vz)|Plasma samples were collected at pre-specified time points and Vz was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric %CV.|Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||Liters||Geometric Coefficient of Variation|Geometric Mean
2533769|NCT03259087|Primary|Part 1: Elimination Terminal Half-life of Plasma MK-3866 (t1/2)|Plasma samples were collected at pre-specified time points and t1/2 was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS. Method of dispersion used for these data is geometric % coefficient of variation (%CV).|Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||Hours||Geometric Coefficient of Variation|Geometric Mean
2533770|NCT03259087|Primary|Part 1: Time to Maximum Plasma Concentration of MK-3866 (Tmax)|Plasma samples were collected at pre-specified time points and Tmax was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS.|Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||Hours||Full Range|Median
2533771|NCT03259087|Primary|Part 1: Plasma Clearance of MK-3866 (CL)|Plasma samples were collected at pre-specified time points and CL was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS.|Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||L/hr||95% Confidence Interval|Geometric Least Squares Mean
2533772|NCT03259087|Primary|Part 1: Maximum Plasma Concentration of MK-3866 (Cmax)|Plasma samples were collected at pre-specified time points and Cmax was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS.|Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the combined comparator experimental groups.|||µM||95% Confidence Interval|Mean
2533773|NCT03259087|Primary|Part 1: Plasma Concentration of MK-3866 at the End of the Infusion (Ceoi)|Plasma samples were collected at pre-specified time points and Ceoi was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS.|At the end of the infusion (0.5 hours after infusion start) on Day 1|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||µM||95% Confidence Interval|Geometric Least Squares Mean
2533774|NCT03259087|Primary|Part 1: Area Under the Plasma Concentration-time Curve of MK-3866 From Time Zero to 24 Hours After Dosing (AUC0-24)|Plasma samples were collected at pre-specified time points and AUC0-24 was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS.|Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, and 24 hours after dosing on Day 1|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2533775|NCT03259087|Primary|Part 1: Area Under the Plasma Concentration-time Curve of MK-3866 From Time Zero to the Time of the Last Quantifiable Sample (AUC0-last)|Plasma samples were collected at pre-specified time points and AUC0-last was assessed. Plasma concentrations of MK-3866 were determined using HPLC-MS/MS.|Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2533776|NCT03259087|Primary|Part 1: Area Under the Plasma Concentration-time Curve of MK-3866 From Time Zero to Infinity (AUC0-inf)|Plasma samples were collected at pre-specified time points and AUC0-inf was assessed. Plasma concentrations of MK-3866 were determined using high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS).|Predose and 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing on Day 1, and 60 and 72 hours after dosing for Severe Renal Impairment participants|All participants who received MK-3866 infusion. Healthy participants were those who matched gender, and mean age and BMI of the comparator experimental group(s).|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2533777|NCT03258814|Secondary|Change From Baseline in Fear-Avoidance Belief Questionnaire Score (FABQ)|The FABQ measures patients' fear of pain and consequent avoidance of physical activity because of their fear. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale, where 0 = completely disagree, 6 = completely agree. There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs.|Baseline and Month 3|No participants had available FABQ data||||||
2533778|NCT03258814|Secondary|Change From Baseline in Severity and Duration of Morning Stiffness|"Morning stiffness was measured as the mean of the 2 morning stiffness-related BASDAI NRS scores:~Question 5: Level of morning stiffness assessed by the patient on a scale from 0 (none) to 10 (very severe), and Question 6: Duration of morning stiffness assessed by the patient on a scale from 0 (0 hours) to 10 (2 hours or more duration)."|Baseline and Month 3|Participants with available data|||scores on a scale||Standard Deviation|Mean
2533779|NCT03258814|Secondary|Change From Baseline in Fatigue|Fatigue was assessed as Question 1 of the BASDAI, on a NRS from 0 (none) to 10 (very severe).|Baseline and Month 3|Participants with available data|||scores on a scale||Standard Deviation|Mean
2533780|NCT03258814|Secondary|Change From Baseline in Modified Work Ability Index (WAI)|This is used to assess participant's work ability.|Baseline and Month 3|No participants had available WAI data||||||
2533784|NCT03258814|Secondary|Percentage of Participants Achieving ASAS Partial Remission|"ASAS partial remission is defined as an absolute score of ≤ 2 units on a 0 to 10 scale for each of the four following domains:~Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Month 3|Participants with available data|||percentage of participants|||Number
2533785|NCT03258814|Secondary|Percentage of Participants Achieving an ASAS 40 Response|"ASAS40 response was defined as improvement of ≥ 40% relative to baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration in the potential remaining domain:~Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Month 3|Participants with available data|||percentage of participants|||Number
2533786|NCT03258814|Secondary|Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response|"ASAS20 response was defined as improvement of ≥ 20% relative to Baseline and absolute improvement of ≥ 1 unit (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 unit) in the potential remaining domain:~Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Month 3|Participants with available data|||percentage of participants|||Number
2533787|NCT03258814|Secondary|Percentage of Participants Achieving ASDAS Clinically Important Improvement|"ASDAS clinically important improvement is defined as a change from Baseline ≥ 1.1.~ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for inactive disease; ≥ 1.3 to < 2.1 for moderate disease activity; ≥ 2.1 to ≤ 3.5 for high disease activity and ≥ 3.5 for very high disease activity."|Baseline and Month 3|Participants with available data|||percentage of participants|||Number
2533788|NCT03258814|Secondary|Percentage of Participants Achieving ASDAS Major Improvement|"ASDAS Major Improvement is defined as a change from Baseline ≥ 2.0. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for inactive disease; ≥ 1.3 to < 2.1 for moderate disease activity; ≥ 2.1 to ≤ 3.5 for high disease activity and ≥ 3.5 for very high disease activity."|Baseline and Month 3|Participants with available data|||percentage of participants|||Number
2533789|NCT03258814|Secondary|Percentage of Participants With ASDAS Very High Disease Activity|"ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for inactive disease; ≥ 1.3 to < 2.1 for moderate disease activity; ≥ 2.1 to ≤ 3.5 for high disease activity and ≥ 3.5 for very high disease activity. The percentage of participants with very high disease activity, defined as an ASDAS ≥ 3.5, is reported."|Month 3|Participants with available data|||percentage of participants|||Number
2533790|NCT03258814|Secondary|Percentage of Participants With ASDAS High Disease Activity|"ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for inactive disease; ≥ 1.3 to < 2.1 for moderate disease activity; ≥ 2.1 to ≤ 3.5 for high disease activity and ≥ 3.5 for very high disease activity. The percentage of participants with high disease activity, defined as an ASDAS ≥ 2.1 to < 3.5, is reported."|Month 3|Participants with available data|||percentage of participants|||Number
2533791|NCT03258814|Secondary|Percentage of Participants With ASDAS Moderate Disease Activity|"ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for inactive disease; ≥ 1.3 to < 2.1 for moderate disease activity; ≥ 2.1 to ≤ 3.5 for high disease activity and ≥ 3.5 for very high disease activity. The percentage of participants with ASDAS moderate disease activity, defined as an ASDAS ≥ 1.3 to < 2.1, is reported."|Month 3|Participants with available data|||percentage of participants|||Number
2533792|NCT03258814|Secondary|Percentage of Participants With ASDAS Low Disease Activity|"ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for inactive disease; ≥ 1.3 to < 2.1 for moderate disease activity; ≥ 2.1 to ≤ 3.5 for high disease activity and ≥ 3.5 for very high disease activity. The percentage of participants with ASDAS low disease activity, defined as ASDAS < 2.1, is reported."|Month 3|Participants with available data|||percentage of participants|||Number
2533793|NCT03258814|Secondary|Percentage of Participants With ASDAS Inactive Disease|"ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for inactive disease; ≥ 1.3 to < 2.1 for moderate disease activity; ≥ 2.1 to ≤ 3.5 for high disease activity and ≥ 3.5 for very high disease activity. The percentage of participants with ASDAS inactive disease, defined as ASDAS < 1.3, is reported."|Month 3|Participants with available data|||percentage of participants|||Number
2533794|NCT03258814|Secondary|Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)|"ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (C-reactive protein [CRP]) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for inactive disease; ≥ 1.3 to < 2.1 for moderate disease activity; ≥ 2.1 to ≤ 3.5 for high disease activity and ≥ 3.5 for very high disease activity."|Baseline and Month 3|Participants with available data|||scores on a scale||Standard Deviation|Mean
2533795|NCT03258814|Secondary|Percentage of Participants Achieving a BASDAI 50 Response|"The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.~A BASDAI 50 response is defined as improvement of 50% or more from baseline in BASDAI score."|Month 3|Participants with available data|||percentage of participants|||Number
2533796|NCT03258814|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 where lower scores indicate less disease activity.|Baseline and Month 3|Participants with available data|||scores on a scale||Standard Deviation|Mean
2533797|NCT03258814|Secondary|Change From Baseline in Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI)|The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. The ASAS HI consists of 17 questions, each answered by the participant as agree (1) or disagree (0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, with a lower score indicating a better and a higher score indicating an inferior health status.|Baseline and Month 3|Participants with available data|||scores on a scale||Standard Deviation|Mean
2533798|NCT03258814|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)|The Bath Ankylosing Spondylitis Functional Index (BASFI) is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities, each on a numeric rating scale (NRS) ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 to 10 with higher score indicating more limitations.|Baseline and Month 3|Participants with available data|||scores on a scale||Standard Deviation|Mean
2533799|NCT03258814|Secondary|Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 3|BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. The total BASMI score ranges from 0 to 10 reflecting mild to moderate disease activity and functional ability in the spinal column. The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis.|Baseline and Month 3|Participants with available data|||scores on a scale||Standard Deviation|Mean
2533800|NCT03258814|Primary|Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 6|BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. The total BASMI score ranges from 0 to 10 reflecting mild to moderate disease activity and functional ability in the spinal column. The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis|Baseline and Month 6|No participants had a Month 6 visit due to early study termination, hence the primary endpoint could not be assessed.||||||
2533825|NCT03258762|Secondary|AUC (0-24) of Pyrimethamine in Healthy Caucasian Male Participants|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.|Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22|Pharmacokinetic Population|||Hours* nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533801|NCT03258762|Secondary|Change From Baseline of ECG Parameter: ECG Mean Heart Rate|A single 12-lead ECG was obtained at indicated time points using an ECG machine that automatically calculates mean ECG heart rate. Day 1 (Pre-dose) value was defined as Baseline for ECG parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.|Baseline (Pre-dose on Day 1), 4, 12, 24, 48, and 504 hours|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||Beats per minute||Standard Deviation|Mean
2533802|NCT03258762|Secondary|Change From Baseline of Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval, and QT Interval Corrected for Heart Rate by Fredericia's Formula (QTcF) Interval|A single 12-lead ECG was obtained at indicated time points using an ECG machine that automatically measures PR, QRS, QT, and QTcF intervals. Day 1 (Pre-dose) value was defined as Baseline for ECG parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.|Baseline (Pre-dose on Day 1), 4, 12, 24, 48, and 504 hours|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||Millisecond||Standard Deviation|Mean
2533803|NCT03258762|Secondary|Change From Baseline in Temperature|Temperature of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.|Baseline (Pre-dose on Day 1), 4, 12, 24, 48, 72, 96, 120, 144, 168, 336 and 504 hours|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||Celsius||Standard Deviation|Mean
2533804|NCT03258762|Secondary|Change From Baseline in Pulse Rate|Pulse rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.|Baseline (Pre-dose on Day 1), 4, 12, 24, 48, 72, 96, 120, 144, 168, 336 and 504 hours|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||Beats per minute||Standard Deviation|Mean
2533805|NCT03258762|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Day 1 (Pre-dose) value was defined as Baseline for vital sign parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.|Baseline (Pre-dose on Day 1), 4, 12, 24, 48, 72, 96, 120, 144, 168, 336 and 504 hours|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2533806|NCT03258762|Secondary|Urine Potential of Hydrogen (pH) at Indicated Time Points|Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Day -1, 24, 96, 168, 336 hours and follow up (504 hours)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||pH||Standard Deviation|Mean
2533807|NCT03258762|Secondary|Specific Gravity at Indicated Time Points|Urine samples were collected for analysis of specific gravity of urine. Urinary specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine.|Day -1, 24, 96, 168, 336 hours and follow up (504 hours)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||Ratio||Standard Deviation|Mean
2533808|NCT03258762|Secondary|Number of Participants With Abnormal Urinalysis Parameter|The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of can be read as Trace, + and ++ indicating proportional concentrations in the urine sample. Only participants with abnormal findings for urinalysis at any visit has been presented.|Day -1, 24, 96, 168, 336 and follow up (504 hours)|Safety Population|||Participants|||Count of Participants
2533809|NCT03258762|Secondary|Change From Baseline in Hematology Parameter: Erythrocytes|Blood samples were collected for the analysis of hematology parameter including erythrocytes at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.|Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||10^12 cells per liter||Standard Deviation|Mean
2533810|NCT03258762|Secondary|Change From Baseline in Hematology Parameter: Mean Corpuscular Volume|Blood samples were collected for the analysis of hematology parameter including mean corpuscular volume at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.|Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||Femtoliter||Standard Deviation|Mean
2533811|NCT03258762|Secondary|Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin|Blood samples were collected for the analysis of hematology parameter including mean corpuscular hemoglobin at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.|Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||Picogram||Standard Deviation|Mean
2533812|NCT03258762|Secondary|Change From Baseline in Hematology Parameter: Hemoglobin|Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.|Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||Gram per liter||Standard Deviation|Mean
2533813|NCT03258762|Secondary|Change From Baseline in Hematology Parameter: Hematocrit|Blood samples were collected for the analysis of hematology parameter including hematocrit at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.|Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||Proportion of red blood cells in blood||Standard Deviation|Mean
2533814|NCT03258762|Secondary|Change From Baseline in Hematology Parameter: Reticulocytes|Blood samples were collected for the analysis of hematology parameter including reticulocytes at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.|Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||Proportion of reticulocytes in blood||Standard Deviation|Mean
2533815|NCT03258762|Secondary|Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and Leukocytes|Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet and leukocytes at indicated time points. Day -1 value was defined as Baseline for hematology parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value. Data was not available as all basophil values were below the detection limit. Hence, the change from baseline in basophil values were not calculated.|Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||10^9 cells per liter||Standard Deviation|Mean
2533816|NCT03258762|Secondary|Change From Baseline of Clinical Chemistry Parameters: Protein|Blood samples were collected for the analysis of clinical chemistry parameter including protein at indicated time points. Day -1 value was defined as Baseline for clinical chemistry parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.|Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||Gram per liter||Standard Deviation|Mean
2533817|NCT03258762|Secondary|Change From Baseline of Clinical Chemistry Parameters: Direct Bilirubin, Bilirubin, Creatinine.|Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, bilirubin and creatinine at indicated time points. Day -1 value was defined as Baseline for clinical chemistry parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.|Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||Micromoles per liter||Standard Deviation|Mean
2533818|NCT03258762|Secondary|Change From Baseline of Clinical Chemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST)|Blood samples were collected for the analysis of clinical chemistry parameters including alkaline phosphatase, ALT and AST at indicated time points. Day -1 value was defined as Baseline for clinical chemistry parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.|Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||International units per liter||Standard Deviation|Mean
2533819|NCT03258762|Secondary|Change From Baseline of Clinical Chemistry Parameters: Glucose, Sodium, Calcium, Potassium, and Urea.|Blood samples were collected for the analysis of clinical chemistry parameters including glucose, sodium, calcium, potassium, and urea at indicated time points. Day -1 value was defined as Baseline for clinical chemistry parameters. Change from Baseline was defined as difference between post-dose visit values minus Baseline value.|Baseline (Day -1), 24, 96, 168, 336 hours and follow up (504 hours)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||Millimoles per liter||Standard Deviation|Mean
2533820|NCT03258762|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or events associated with liver injury and impaired liver function were categorized as SAE. All participants who take at least one dose of study treatment were included in Safety Population.|Up to Day 23|Safety Population|||Participants|||Count of Participants
2533821|NCT03258762|Secondary|Vd/F of Pyrimethamine in Healthy Caucasian Male Participants|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.|Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22|Pharmacokinetic Population|||Milliliters||Geometric Coefficient of Variation|Geometric Mean
2533822|NCT03258762|Secondary|CL/F of Pyrimethamine in Healthy Caucasian Male Participants|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.|Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22|Pharmacokinetic Population|||Milliliters per hour||Geometric Coefficient of Variation|Geometric Mean
2533823|NCT03258762|Secondary|T1/2 of Pyrimethamine in Healthy Caucasian Male Participants|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.|Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22|Pharmacokinetic Population|||Hours||Standard Deviation|Mean
2533824|NCT03258762|Secondary|Tmax of Pyrimethamine in Healthy Caucasian Male Participants|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.|Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22|Pharmacokinetic Population|||Hours||Full Range|Median
2533826|NCT03258762|Secondary|AUC (0-inf) of Pyrimethamine in Healthy Caucasian Male Participants|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.|Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22|Pharmacokinetic Population|||Hours* nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533827|NCT03258762|Secondary|AUC (0-t) of Pyrimethamine in Healthy Caucasian Male Participants|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.|Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22|Pharmacokinetic Population|||Hours* nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533828|NCT03258762|Secondary|Cmax of Pyrimethamine in Healthy Caucasian Male Participants|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.|Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22|Pharmacokinetic Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533829|NCT03258762|Primary|Apparent Volume of Distribution Following Oral Dosing (Vd/F) of Pyrimethamine in Healthy Japanese Male Participants|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.|Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22|Pharmacokinetic Population|||Milliliter||Geometric Coefficient of Variation|Geometric Mean
2533830|NCT03258762|Primary|Apparent Clearance Following Oral Dosing (CL/F) of Pyrimethamine in Healthy Japanese Male Participants|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.|Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22|Pharmacokinetic Population|||Milliliter per hour||Geometric Coefficient of Variation|Geometric Mean
2533831|NCT03258762|Primary|Time to Maximum Observed Concentration (Tmax) of Pyrimethamine in Healthy Japanese Male Participants|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.|Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22|Pharmacokinetic Population|||Hours||Full Range|Median
2533832|NCT03258762|Primary|Terminal Half-life (t1/2) of Pyrimethamine in Healthy Japanese Male Participants|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.|Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22|Pharmacokinetic Population|||Hours||Geometric Coefficient of Variation|Geometric Mean
2533833|NCT03258762|Primary|Area Under the Concentration-time Curve From Time 0 to 24 (AUC[0-24]) of Pyrimethamine in Healthy Japanese Male Participants|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.|Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22|Pharmacokinetic Population|||Hours* nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533834|NCT03258762|Primary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) of Pyrimethamine in Healthy Japanese Male Participants|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.|Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22|Pharmacokinetic Population|||Hours* nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533835|NCT03258762|Primary|Area Under the Concentration-time Curve From Time 0 to t (AUC[0-t]) of Pyrimethamine in Healthy Japanese Male Participants|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.|Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22|Pharmacokinetic Population|||Hours* nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533836|NCT03258762|Primary|Maximum Observed Concentration (Cmax) of Pyrimethamine in Healthy Japanese Male Participants|Blood samples were collected at indicated time points. The Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis. PK Population is defined as all participants who administered at least one dose of study treatment and who have PK sample taken and analyzed.|Pre-dose, 1, 2, 4, 6, 12 hours post-dose on Day 1, Day 2, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22|Pharmacokinetic Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2533837|NCT03258710|Secondary|Change From Baseline Values for Bone Density|Bone densitometry was performed on lumbar spine and femur using dual-energy X-ray absorptiometry (DEXA). Bone density percentage was calculated as bone density observation minus bone density Baseline divided by bone density Baseline. Baseline was considered as Day -1. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day -1) and at Weeks 24 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Grams per centimeter^2||Standard Deviation|Mean
2533838|NCT03258710|Secondary|Number of Participants With Worst Case Post-Baseline Electrocardiogram (ECG) Values|Twelve-lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Abnormal values with clinically significant and not clinically significant values has been presented.|Up to Week 48|Safety Population.|||Participants|||Count of Participants
2533839|NCT03258710|Secondary|Absolute Values for Temperature|Temperature of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||degrees Celsius||Standard Deviation|Mean
2533840|NCT03258710|Secondary|Absolute Values for Heart Rate|Heart rate of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Beats per minute||Standard Deviation|Mean
2539140|NCT03079375|Primary|Emergency Department Visits|number of patients who have emergency department visits|180 days||||Participants|||Count of Participants
2533841|NCT03258710|Secondary|Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure|Blood pressure of participants were measured at indicated time points in supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimeters of mercury||Standard Deviation|Mean
2533842|NCT03258710|Secondary|Change From Baseline Values for Urine Creatinine Concentration and Urine Phosphate|Urine samples were collected for analysis of urinalysis data for urine creatinine concentration and urine phosphate. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Milligrams per deciliter||Standard Deviation|Mean
2533843|NCT03258710|Secondary|Change From Baseline Values for Beta-2-microglobulin|Urine samples were collected for analysis of urinalysis data for beta-2-microglobulin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Micrograms per liter||Standard Deviation|Mean
2533844|NCT03258710|Secondary|Number of Participants With Abnormal Urinalysis Values|Urine samples were collected for analysis of urinalysis data for glucose, protein and urinary sediment by dipstick method. The urine sediments analyzed were amorphous phosphate crystals, amorphous urate crystals, bacteria, calcium oxalate crystals, ammonium magnesium phosphate, renal tubular epithelial cells (RTEC), fungi, hyaline casts, mucous threads, RBCs, spermatozoa, squamous epithelial cells (SEC), transitional epithelial cells (TEC), uric acid crystals (UAC) and WBCs. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine protein and urine glucose can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Trace, 1+ and 2+ urinalysis values has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only abnormal parameters and participants with abnormal data has been reported.|Weeks 4, 12, 24, 36 and 48|Safety Population.|||Participants|||Count of Participants
2533845|NCT03258710|Secondary|Absolute Values for Hematology Parameter: Red Blood Cell (RBC) Count|Blood samples were collected for the analysis of hematology parameter, RBC count. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Trillion cells per liter||Standard Deviation|Mean
2533846|NCT03258710|Secondary|Absolute Values for Hematology Parameter: Prothrombin Time|Blood samples were collected for the analysis of hematology parameter, prothrombin time. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Seconds||Standard Deviation|Mean
2533847|NCT03258710|Secondary|Absolute Values for Hematology Parameters: Platelet Count and White Blood Cell (WBC) Count|Blood samples were collected for the analysis of hematology parameters: platelet count and WBC count. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Giga cells per liter||Standard Deviation|Mean
2533848|NCT03258710|Secondary|Absolute Values for Hematology Parameter: Hematocrit|Blood samples were collected for the analysis of hematology parameter, hematocrit. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Proportion of red blood cells in blood||Standard Deviation|Mean
2533849|NCT03258710|Secondary|Absolute Values for Hematology Parameter: Hemoglobin|Blood samples were collected for the analysis of hematology parameter, hemoglobin. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2533850|NCT03258710|Secondary|Percentage of Total Neutrophils at Indicated Time Points|Blood samples were collected for the analysis of hematology parameter: total neutrophils. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Mean and standard deviation values for percentage of neutrophils reported was presented.|At Weeks 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percentage of neutrophils||Standard Deviation|Mean
2533851|NCT03258710|Secondary|Percentage of Monocytes at Indicated Time Points|Blood samples were collected for the analysis of hematology parameter: monocytes. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Mean and standard deviation values for percentage of monocytes reported was presented.|At Weeks 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percentage of monocytes||Standard Deviation|Mean
2533960|NCT03255824|Secondary|Hemodynamic Stability - Blood Pressure|"To compare the differences in hemodynamic stability using a D/M combination compared to the MFP combination. (In this study, a deviation from baseline by 20% or greater will be considered clinically significant)~a. Change in blood pressure (NIBP) (change ≥ 20%) HEART RATE IS PRESENTED AS MEAN ARTERIAL PRESSURE"|During the procedure, up to 40 minutes||||mm Hg||Standard Deviation|Mean
2533852|NCT03258710|Secondary|Percentage of Lymphocytes at Indicated Time Points|Blood samples were collected for the analysis of hematology parameter: lymphocytes. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Mean and standard deviation values for percentage of lymphocytes reported was presented.|At Weeks 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percentage of lymphocytes||Standard Deviation|Mean
2533853|NCT03258710|Secondary|Percentage of Eosinophils at Indicated Time Points|Blood samples were collected for the analysis of hematology parameter: eosinophils. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Mean and standard deviation values for percentage of eosinophils reported was presented.|At Weeks 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percentage of eosinophils||Standard Deviation|Mean
2533854|NCT03258710|Secondary|Percentage of Basophils at Indicated Time Points|Blood samples were collected for the analysis of hematology parameter: basophils. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Mean and standard deviation values for percentage of basophils reported was presented.|At Weeks 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percentage of basophils||Standard Deviation|Mean
2533855|NCT03258710|Secondary|Absolute Values for Clinical Chemistry Parameter: Glomerular Filtration Rate (GFR)|Blood samples were collected for the analysis of clinical chemistry parameter, GFR. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Milliliters per second per 1.73*meter^2||Standard Deviation|Mean
2533856|NCT03258710|Secondary|Absolute Values for Clinical Chemistry Parameter: Creatinine Clearance|Blood samples were collected for the analysis of clinical chemistry parameter, creatinine clearance. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Milliliters per minute||Standard Deviation|Mean
2533857|NCT03258710|Secondary|Absolute Values for Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Lactic Acid, Sodium, Phosphorus and Blood Urea Nitrogen (BUN)|Blood samples were collected for the analysis of clinical chemistry parameters: calcium, chloride, glucose, potassium, lactic acid, sodium, phosphorus inorganic and BUN. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2533858|NCT03258710|Secondary|Absolute Values for Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid|Blood samples were collected for the analysis of clinical chemistry parameters: direct bilirubin, total bilirubin, creatinine and uric acid. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2533859|NCT03258710|Secondary|Absolute Values for Clinical Chemistry Parameters: Amylase and Lipase|Blood samples were collected for the analysis of clinical chemistry parameters: amylase and lipase. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Units per liter||Standard Deviation|Mean
2533860|NCT03258710|Secondary|Absolute Values for Clinical Chemistry Parameters: Alkaline Phosphate (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatinine Kinase (CPK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH)|Blood samples were collected for the analysis of clinical chemistry parameters: ALP, ALT, AST, CPK, GGT and LDH. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||International units per liter||Standard Deviation|Mean
2533861|NCT03258710|Secondary|Absolute Values for Clinical Chemistry Parameters: Albumin and Total Protein|Blood samples were collected for the analysis of clinical chemistry parameters: albumin and total protein. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2533862|NCT03258710|Secondary|Absolute Values for Clinical Chemistry Parameter: Alpha-fetoprotein (AFP)|Blood samples were collected for the analysis of clinical chemistry parameter, AFP. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and at Weeks 4, 12, 24, 36 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Micrograms per liter||Standard Deviation|Mean
2533882|NCT03257995|Secondary|Relative Bioavailability (Frel) of Indacaterol Acetate and Indacaterol Maleate|Relative bioavailability will be determined for AUC0-24h,ss and Cmax,ss comparing systemic exposure of indacaterol acetate and indacaterol maleate.|Day 14|The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data. Only summary statistics for relative bioavailability was provided.|||Ratio||Standard Deviation|Mean
2533863|NCT03258710|Secondary|Number of Participants Who Reported Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety Population consists of participants who have received at least one dose of study treatment after enrolment.|Up to Week 48|Safety Population.|||Participants|||Count of Participants
2533864|NCT03258710|Secondary|Change From Baseline Log Values for HBcrAg Titer at Weeks 24 and 48|Blood samples were collected to evaluate the HBcrAg titer at Weeks 24 and 48. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1, Pre-dose) and at Weeks 24 and 48|FAS Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Log Kilounits per Liter||Standard Deviation|Mean
2533865|NCT03258710|Secondary|Change From Baseline Log Values for HBsAg Titer at Weeks 24 and 48|Blood samples were collected to evaluate the HBsAg titer at Weeks 24 and 48. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1, Pre-dose) and at Weeks 24 and 48|FAS Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Log Kilo International Units per Liter||Standard Deviation|Mean
2533866|NCT03258710|Secondary|Percentage of Participants Who Achieved HBeAg/Ab Seroconversion at Weeks 24 and 48|Blood samples were collected to evaluate the percentage of participants who achieved HBeAg/Ab seroconversion at Weeks 24 and 48. Seroconversion of HBeAg means antigen is negative and antibody is positive. HBeAg Seroconversion percentage is defined as numbers of participants with HBeAg/Ab Seroconversion divided by numbers of participants with positive HBeAg and Negative HBeAb at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|At Weeks 24 and 48|FAS Population. Only those participants with data available at specified data points were analyzed.|||Percentage of Participants|||Number
2533867|NCT03258710|Secondary|Percentage of Participants Who Achieved HBeAg Loss at Weeks 24 and 48|Blood samples were collected to evaluate the percentage of participants with HBeAg loss at Weeks 24 and 48. A 'Loss' of HBeAg means antigen is negative. HBeAg Loss percentage is defined as numbers of participants with HBeAg loss divided by numbers of participants with positive HBeAg at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|At Weeks 24 and 48|FAS Population. Only those participants with data available at specified data points were analyzed.|||Percentage of Participants|||Number
2533868|NCT03258710|Secondary|Percentage of Participants Who Achieved HBsAg/Ab Seroconversion at Weeks 24 and 48|Blood samples were collected to evaluate the percentage of participants who achieved HBsAg/Ab seroconversion at Weeks 24 and 48. Seroconversion of HBsAg means antigen is negative and antibody is positive. HBsAg Seroconversion percentage is defined as numbers of participants with HBsAg/Ab Seroconversion divided by numbers of participants with positive HBsAg and Negative HBsAb at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|At Weeks 24 and 48|FAS Population. Only those participants with data available at specified data points were analyzed.|||Percentage of Participants|||Number
2533869|NCT03258710|Secondary|Percentage of Participants Who Achieved HBsAg Loss at Weeks 24 and 48|Blood samples were collected to evaluate the percentage of participants with HBsAg loss at Weeks 24 and 48. A 'Loss' of HBsAg means antigen is negative. HBsAg Loss percentage is defined as numbers of participants with HBsAg loss divided by numbers of participants with positive HBsAg at Baseline. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|At Weeks 24 and 48|FAS Population.|||Percentage of Participants|||Number
2533870|NCT03258710|Secondary|Percentage of Participants Who Achieved 0.25 Log10 HBsAg Reduction From the Baseline at Week 24|Blood samples were collected to evaluate the HBsAg reduction potential from Baseline at Week 24. HBsAg reduction potential was obtained by evaluating log10 observation values minus log10 Baseline values. Data for HBsAg responder values has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Day 1, Pre-dose) and at Week 24|FAS Population.|||Percentage of Participants||95% Confidence Interval|Number
2533871|NCT03258710|Primary|Percentage of Participants Who Achieved 0.25 Log10 Hepatitis B Surface Antigen (HBsAg) Reduction From the Baseline at Week 48|Blood samples were collected to evaluate the HBsAg reduction from Baseline at Week 48. HBsAg reduction potential was obtained by evaluating log10 observation values minus log10 Baseline values. The HBsAg responder values were <=-0.25 log10 and non-responder values were >-0.25 log10 . Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Full analysis set (FAS) Population is defined as population of all participants enrolled in the study, excluding those who meet either of the following criteria: who have not received any dose of study treatment and who have no efficacy data (HBsAg, HBV-DNA, hepatitis B core-related antigen [HBcrAg], HBeAg, hepatitis B surface antibody [HBsAb], Hepatitis B envelope antibody [HBeAb], alanine aminotransferase [ALT]) from at least 15 days after the start of study treatment. Data for HBsAg responder values has been presented.|Baseline (Day 1, Pre-dose) and at Week 48|FAS Population.|||Percentage of Participants||95% Confidence Interval|Number
2533883|NCT03257995|Secondary|The Lowest Plasma (or Serum or Blood) Concentration (Cmin) at Steady State|The lowest plasma (or serum or blood) concentration observed during a dosing interval at steady state. Only summary statistics was provided.|Day 14 of each of the three treatment periods|The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data.|||pg/mL||Full Range|Median
2537971|NCT03118739|Other Pre-specified|Baseline MRI Variables - Circumferential Strain||Baseline|Total number differs from Study totals due to subject non compliance with MRI (exam not completed)|||% (change in percentage in LV dimension)||Standard Deviation|Mean
2533872|NCT03257995|Secondary|Mean Overall Peak Expiratory Flow (PEF)|A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits LS Mean of change from baseline in mean morning PEF is calculated with the ANOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates|Days 8 through Day 14 of each of the three treatment periods|The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data|||Liters/min||Standard Error|Least Squares Mean
2533873|NCT03257995|Secondary|Rescue Medication Usage|The mean daily number of puffs of rescue medication usage as reported by subjects via diary.|14 days of treatment for each of the three treatment periods|The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data|||Puffs||Standard Error|Least Squares Mean
2533874|NCT03257995|Secondary|Bronchodilator Effect of Indacaterol Salts Compared to Placebo in Standardized FEV1 AUC.|Standardized FEV1 AUC from pre-dose to 4 h post-dose. Evaluated the differences in standardized FEV1 AUC0-4h (L) after 14 days of treatment between indacaterol maleate 150 μg and placebo, and between indacaterol acetate 150 μg and placebo. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-4h)|Pre-dose to 4 hours post-dose on Day 14 of each of the three treatment periods|The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data|||Liters||Standard Error|Least Squares Mean
2533875|NCT03257995|Secondary|Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEF25-75%|The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry at each post dose time point after 14 days|Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min|The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data|||Liters/second||95% Confidence Interval|Least Squares Mean
2533876|NCT03257995|Secondary|Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEV1/FVC|Bronchodilator effect of indacaterol salts compared to placebo in terms of FEV1/FVC at each post dose time point after 14 days. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.|Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min|The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data|||Ratio||95% Confidence Interval|Least Squares Mean
2533877|NCT03257995|Secondary|Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FVC (% Predicted)|Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry at each post dose time point after 14 days. A positive change from baseline in FVC indicates improvement in lung function.|Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min|The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data|||Percentage of predicted FVC||95% Confidence Interval|Least Squares Mean
2533878|NCT03257995|Secondary|Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by Forced Vital Capacity (FVC)|Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry at each post dose time point after 14 days. A positive change from baseline in FVC indicates improvement in lung function.|Day 14 of each of the three treatment periods at at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min|The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data|||liter||95% Confidence Interval|Least Squares Mean
2533879|NCT03257995|Secondary|Percent of Predicted Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by FEV1 (% Predicted) at All Timepoints|"The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. FEV1 % predicted was assessed at each post dose time point after 14 days"|Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min|The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data|||Percent of predicted||95% Confidence Interval|Least Squares Mean
2533880|NCT03257995|Secondary|Bronchodilator Effect of Indacaterol Salts Compared to Placebo Measured by Forced Expiratory Volume in 1 Second (FEV1) at All Timepoints|Bronchodilator effect of indacaterol salts compared to placebo in terms of FEV1. Day 14, FEV1 was measured at 24hours post dose|Day 14 of each of the three treatment periods at 5, 15, 30m, 1 2, 3, 4, 8, 12, 23hour.15min and 23hour.45min|The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data|||Liter||95% Confidence Interval|Least Squares Mean
2533881|NCT03257995|Secondary|Time to Peak FEV1 on Day 14|The differences in median time to peak FEV1 (h) between indacaterol maleate 150 µg and placebo|Day 14 of each of the three treatment periods|The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data|||h||95% Confidence Interval|Median
2533963|NCT03255824|Secondary|Surgeon Satisfaction - Survey|"Surgeon satisfaction was measured by the surgeon grading the Operating Conditions scale.~The minimum value was 0 and the maximum was 3. 0=very poor, 1=poor, 2=fair, 3=good"|15 minutes following surgery||||score on a scale||Standard Deviation|Mean
2533884|NCT03257995|Secondary|Time of Maximal Plasma Concentration (Tmax) at Steady State|Time of maximal plasma concentration of indacaterol maleate and indacaterol acetate at steady state. Time to reach the maximum concentration after administration. In this analysis Tmax will be reported using blood samples taken on Days 14|Day 14 of each of the three treatment periods|The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data.|||h||Full Range|Median
2533885|NCT03257995|Secondary|The Maximum Concentration (Cmax) at Steady State (ss)|Maximal plasma concentrations of indacaterol maleate and indacaterol acetate at steady state. The maximum concentration (Cmax) were obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration in the blood samplings.|Day 14 of each of the three treatment periods|The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data.|||pg/mL||Full Range|Median
2533886|NCT03257995|Secondary|Pharmacokinetics AUC 0-24hours at Steady State|AUC 0-24hours of plasma concentrations of indacaterol maleate and indacaterol acetate at steady state.The area under the concentrations-time curve (AUC0-24) was calculated with the measured data points from the time of administration up to 24 h after administration by the trapezoidal formula. The concentration-time curve is the result of time points of blood sampling and its measured concentration in the blood samplings|Day 14 of each of the three treatment periods|The PK analysis set included all patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no major protocol deviations with relevant impact on PK data.|||h*pg/mL||Standard Deviation|Mean
2533887|NCT03257995|Primary|Trough FEV1|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of forced exhalation. Treatment differences in trough FEV1 after 14 days of treatment between indacaterol maleate 150 μg and placebo, between indacaterol acetate 150 μg and placebo and indacaterol maleate and indacaterol acetate|Day 14 of each of the three treatment periods|The PD analysis set included all patients with available PD parameter data who received any study drug and experienced no major protocol deviations with relevant impact on PD data|||Liters||Standard Deviation|Mean
2533888|NCT03257865|Secondary|Change From Baseline In Clinical Global Impression-Bipolar (CGI-BP) Severity Score In Mania At Week 3|The CGI-BP scale refers to the global impression of the participant with respect to bipolar disorder. The scale rates the participant's severity of illness (CGI-BP severity of illness: mania, depression, and overall bipolar illness) based on a 7-point scale: 1 = normal, not at all ill, 2 = minimally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = very severely ill.|Baseline, Week 3|Full Analysis Set: all participants who received at least 1 dose of study drug and had a baseline value and at least 1 valid post-randomization efficacy evaluation for YMRS Total Score in the double-blind treatment phase at the specified timepoint.|||units on a scale||Standard Deviation|Mean
2533889|NCT03257865|Primary|Change From Baseline In Young-Mania Rating Scale (YMRS) Score At Week 3|"The YMRS was utilized to assess a participant's level of manic symptoms. It consists of 11 items: 1) elevated mood, 2) increased motor activity-energy, 3) sexual interest, 4) sleep, 5) irritability, 6) speech (rate and amount), 7) language-thought disorder, 8) content, 9) disruptive-aggressive behavior, 10) appearance, and 11) insight. Seven items are rated on a 0- to 4-scale, while four items (Items 5, 6, 8, and 9) are rated on a 0- to 8-scale with 0, 2, 4, 6, and 8 being the possible scores (twice the weight of the other items). For all items, 0 is the best rating and the highest score (4 or 8) is the 'worst' rating. The YMRS total score is the sum of ratings for all 11 items; therefore, possible total scores range from 0 to 60, with higher scores signifying more severe manic symptoms. Comparison between treatment groups was carried out using mixed-effect model repeated measure (MRMM)."|Baseline, Week 3|Full Analysis Set: all participants who received at least 1 dose of study drug and had a baseline value and at least 1 valid post-randomization efficacy evaluation for YMRS Total Score in the double-blind treatment phase at the specified timepoint.|||units on a scale||Standard Error|Least Squares Mean
2533890|NCT03257813|Other Pre-specified|Number of Eyes With Foreign Body Sensation|Foreign body sensation will be evaluated by the presence or absence of it and the number of affected by group will be reported.|Baseline (day 1) crossover visit (day 30) and final visit (day 60)|the statistical analysis was carried out taking into account each eye as a case number, therefore, each research subject could provide 2 cases.|||eyes|eyes||Number
2533891|NCT03257813|Other Pre-specified|Number of Eyes With Tearing|Tearing will be evaluated by the presence or absence of it and the number of affected by group will be reported|Baseline (day 1) crossover visit (day 30) and final visit (day 60)|the statistical analysis was carried out taking into account each eye as a case number, therefore, each research subject could provide 2 cases.|||eyes|eyes||Number
2533892|NCT03257813|Other Pre-specified|Eye Burning|Eye ocular burning will be evaluated by the presence or absence of it and the number of affected by group will be reported.|Baseline (day 1) crossover visit (day 30) and final visit (day 60)|the statistical analysis was carried out taking into account each eye as a case number, therefore, each research subject could provide 2 cases.|||number of eye burning|eyes||Number
2533893|NCT03257813|Other Pre-specified|Chemosis|Chemosis: qualitative ordinal variable, will be evaluated by the presence or absence of it and the percentage of affected by group will be reported.|Baseline (day 1) crossover visit (day 30) and final visit (day 60)|the statistical analysis was carried out taking into account each eye as a case number, therefore, each research subject could provide 2 cases.|||percentage of chemosis|eyes||Number
2533894|NCT03257813|Other Pre-specified|Conjunctival Hyperemia|the conjunctival hyperemia will be evaluated by the presence or absence of it and the percentage of affected by group will be reported.|Baseline (day 1) crossover visit (day 30) and final visit (day 60)|the statistical analysis was carried out taking into account each eye as a case number, therefore, each research subject could provide 2 cases.|||percentage of eyes|eyes||Number
2533895|NCT03257813|Other Pre-specified|Adverse Events|The presence of adverse events by percentage between groups will be evaluated. the scale is present or absent.|75 days, includes the security call|the statistical analysis was carried out taking into account each eye as a case number, therefore, each research subject could provide 2 cases. statistical analysis by intention to treat (ITT)|||percentage of adverse events|eyes||Number
2533896|NCT03257813|Secondary|Visual Acuity (VA)|"The VA will be evaluated basally, without refractive correction with the Snellen chart. A Snellen chart is placed at a standard distance: 20 ft. At this distance, the symbols on the line representing normal acuity subtend. This line, designated 20/20 is the smallest line that a person with normal acuity can read at a distance of 20fs. the scale consists of 11 lines of letters of different size, the size of the letter gives a fractional value according to the visual acuity of the patient, the value is inversely proportional to the visual acuity, if the denominator is greater the visual acuity will be less.~Line 1: 20/200 Line 2: 20/100, Line 3: 20/70, line 4: 20/50, line 5: 20/40, Line 6: 20/30, line 7: 20/25, Line 8: 20/20, line 9: 20/15, line 10: 20/13, line 11: 20/10. the differences between groups in the basal, cross over and final visit will be evaluated."|Visual Acuity at Baseline (day 1) crossover visit (day 30) and final visit (day 60)|the statistical analysis was carried out taking into account each eye as a case number, therefore, each research subject could provide 2 cases.|||score on a scale|eyes|Standard Error|Mean
2533897|NCT03257813|Primary|Intraocular Pressure (IOP)|"Intraocular pressure, Unit: Millimeters of mercury (mmHg) type of variable: Continuous, Measurement method: Goldman applanation tonometry. Normal intraocular pressure 11-21 mmHg.~The change between the IOP of both groups was compared (sequence 1 versus sequence 2) of the data obtained at the end of each period (day 30 and day 60)."|Change from Baseline intraocular pressure at day 30 and 60.|the statistical analysis was carried out taking into account each eye as a case number, therefore, each research subject could provide 2 cases.|||mmHg|eyes|Standard Deviation|Mean
2533898|NCT03257657|Secondary|Changes in Diet: kCal Intake|To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.|Baseline and 12 weeks|Data missing for one Lifestyle Group participant at the 12 week point|||kcal||Standard Deviation|Mean
2533899|NCT03257657|Secondary|Changes in Diet: Intakes Measured in Cups|To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults. Fruit and vegetable intake changes are measured and reported in cups.|Baseline and 12 weeks|Data missing for one Lifestyle Group participant at the 12 week point|||Cups||Standard Deviation|Mean
2533900|NCT03257657|Secondary|Changes in Readiness to Change|Investigators will evaluate any differences in readiness to change from baseline to 12 weeks between intervention and control groups by participants completing the Readiness to Change questionnaire. Possible range = -3 to 3; higher scores indicate greater change in readiness to change|Baseline and 12 weeks||||units on a scale||Inter-Quartile Range|Mean
2533901|NCT03257657|Secondary|Changes in Motivations to Eat|"To determine differences from baseline to12 weeks in motivations to eat between intervention and control groups, participants will complete the Eating Stimulus Index questionnaire.~Possible range = -92 to 92. Higher scores indicated improved lifestyle-related behaviors and motivations to eat."|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2533902|NCT03257657|Secondary|Changes in Diet and Physical Activity Self-efficacy|"To determine differences in self-efficacy from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of Eating Habits Confidence Survey and Exercise Confidence Survey.~Diet self-efficacy: Possible range: -32 to 32; Higher scores indicate improved self-efficacy.~Physical activity self-efficacy: Sticking to it scale: Possible range: -32 to 32; Higher scores indicate improved self-efficacy.~Making time scale: -12 to 12; Higher scores indicate improved self-efficacy."|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2533903|NCT03257657|Secondary|Changes in Physical Activity|To determine differences in total physical activity from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of the Pregnancy Physical Activity Questionnaire. This is a validated survey measure for physical activity.|Baseline and 12 weeks||||MET-h/week||Standard Deviation|Mean
2533904|NCT03257657|Secondary|Changes in Diet: Intakes Measured in Grams|To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.|Baseline and 12 weeks|Data missing for one Lifestyle Group participant at the 12 week point|||Grams||Standard Deviation|Mean
2533905|NCT03257657|Secondary|Change in Weight Between Visits|To determine differences in change in weight between the intervention and control groups, participants will be weighed on a scale in the Women, Infants, and Children (WIC) setting.|Intervention group: Baseline, 12 weeks; Control group: Baseline and 12 weeks||||pounds||Standard Deviation|Mean
2533906|NCT03257657|Primary|Evaluation of the Use of Phone Coaching|Investigators will count the total number of times any participant used phone coaching.|12 weeks||||Number of phone coaching sessions|||Number
2533907|NCT03257657|Primary|Acceptability of a Weight Loss Intervention|To determine acceptability, investigators will use qualitative interviews to ask open-ended questions on this topic including asking participants in the intervention whether they would participate again. The number of participants interviewed who indicated that they would participate again is reported.|12 weeks|Data was not available for analysis for one participant. This participant was not analyzed. The three participants lost to follow-up before the baseline visit were not available for interview and are excluded.|||Participants|||Count of Participants
2533908|NCT03257657|Primary|Visit Attendance|The investigators will measure lifestyle group participant attendance from enrollment through the 12-week visit. The number of participants who attended their visits is reported|Baseline through Week 12, reported at Week 12|2 participants are excluded from analysis: Participant who was withdrawn was not included in analysis. Participant identified as not eligible right after enrollment is not included either.|||Participants|||Count of Participants
2533909|NCT03257657|Primary|Attrition Rate of Subjects Enrolled in the Study|The investigators will measure the number of dropouts/withdrawn once final participant has completed the 12 week visit.|Once the final participant completes the 12 week visit|The 1 participant originally enrolled, but removed right after enrollment because was determined not eligible is not included in the Lifestyle group count.|||Participants|||Count of Participants
2533964|NCT03255824|Secondary|Patient Satisfaction|"Visual Analog Scale was used to measure overall satisfaction with the IV sedation and memory of the procedure.~The minimum score is 0 (not satisfied at all) to a maximum score of 100 (completely satisfied).~A higher score is a better outcome."|30 minutes following surgery||||score on a scale||Standard Deviation|Mean
2533910|NCT03257657|Primary|Feasibility of Recruitment|The investigators plan to determine the feasibility of recruitment for a weight loss intervention by evaluating the rate of recruitment. Below describes number recruited/enrolled over 14 weeks of recruitment|Once the final participant is recruited|One participant was consented but determined before receiving any interventions that they did not meet all eligibility criteria. This participant is excluded from the lifestyle group.|||participants|||Number
2533911|NCT03257631|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|Treatment-emergent adverse events were defined as any adverse events (AE) occurring from the first dose of pomalidomide until 28 days after the last dose. The severity of each AE was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 and according to the following scale: Grade 1: Mild (transient or mild discomfort; no limitation in activity or medical intervention required); Grade 2: Moderate (mild to moderate limitation in activity, assistance may be needed; minimal medical intervention required); Grade 3: Severe (marked limitation in activity, assistance and medical intervention required, hospitalization possible); Grade 4: Life-threatening (extreme limitation in activity, significant assistance or medical intervention required, hospitalization or hospice care probable); Grade 5: Death. Drug-related AEs are those suspected by the Investigator as being related to administration of study drug.|From first dose of pomalidomide until 28 days after the last dose; median treatment duration was 84 days in the DIPG group, 112.0 days in the ependymoma group, 40.5 days in the high-grade glioma group and 57.0 days in the medulloblastoma group.|The safety population included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2533912|NCT03257631|Secondary|Kalan-Meier Estimate of Overall Survival|Overall survival was defined as the time from the date of the first dose to the date of death (any cause). Participants who were alive were censored at the last known time that the participant was alive.|From the first dose of pomalidomide to the data cut-off date of 15 March 2019; median overall time on follow-up was 4.86 months (3.78, 5.65, 4.04, and 8.38 months in each group respectively).|Response population|||months||95% Confidence Interval|Median
2533913|NCT03257631|Secondary|Kaplan-Meier Estimate of Progression-Free Survival (PFS)|Progression-free survival was defined as the time from the date of first dose of pomalidomide until the date progressive disease (PD) was first observed or until the date of death due to any cause, whichever occurred first. Participants who did not have PD or had not died at the time of analysis were censored at the time of their last disease assessment or at the start of new anticancer therapy, whichever occurred first. Progressive Disease (PD): ≥ 25% increase in the size of the measurable lesions taking as a reference the smallest disease measurement recorded since the start of protocol therapy (nadir), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or if spine MRI and/or lumbar CSF cytology were previously negative and became positive.|From the first dose of pomalidomide to the data cut-off date of 15 March 2019; median overall time on follow-up was 4.86 months (3.78, 5.65, 4.04, and 8.38 months in each group respectively).|Response population|||weeks||95% Confidence Interval|Median
2533914|NCT03257631|Secondary|Kaplan-Meier Estimate of Duration of Response|Duration of response is defined as the time from the date of the first objective response (complete response or partial response) to disease progression, for participants with a response. Participants who did not have disease progression or had not died were censored at the time of their last disease assessment or at the time of start of new anticancer therapy, whichever occurred first. Progressive disease (PD): ≥ 25% increase in the size of the measurable lesions taking as a reference the smallest disease measurement recorded since the start of protocol therapy (nadir), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions, or if spine MRI and/or lumbar cerebrospinal fluid (CSF) cytology were previously negative and became positive.|From the first dose of pomalidomide to the data cut-off date of 15 March 2019; median overall time on follow-up was 4.86 months (3.78, 5.65, 4.04, and 8.38 months in each group respectively).|Participants in the response population with an objective response|||weeks||95% Confidence Interval|Median
2533915|NCT03257631|Secondary|Percentage of Participants With Long-term Stable Disease|Long-term stable disease (SD) rate was defined as the percentage of participants who achieved SD maintained for ≥ 6 cycles (or > 3 cycles for DIPG), measured from the date of first dose of treatment. Disease assessments were based on MRI and assessed by an independent central review. SD: A decrease of < 50% or an increase of < 25% in the size of measurable lesions and no evidence of new lesions, response does not meet the criteria for CR, PR, or progressive disease, and/or the persistence of non-target lesions with no progression or decrease in size.|6 months (first 6 cycles) or 3 months (first 3 cycles) for participants in the DIPG group|Response population|||percentage of participants||95% Confidence Interval|Number
2533916|NCT03257631|Secondary|Percentage of Participants Who Achieved an Objective Response|Objective response rate was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) within the first 6 cycles of treatment (or within 3 cycles for participants in the DIPG group). Disease assessments were based on MRI and assessed by an independent central review. CR: Disappearance of all lesions and no new lesions. PR: A reduction of ≥ 50% in the size of measurable lesions compared to baseline, and/or the persistence of non-target lesions with no progression or decrease in size.|6 months (first 6 cycles) or 3 months (first 3 cycles) for participants in the DIPG group|Response population|||percentage of participants||95% Confidence Interval|Number
2533926|NCT03257189|Primary|Accuracy of Heart Rate Variability Measured by Root Mean Square of Successive Differences (HRV RMSSD) Compared to the Reference Device|Heart Rate Variability RMSSD is measured by the subject device determined by root mean square of successive differences in neighboring RR intervals and will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.|2 days after informed consent|One comparator device malfunctioned, resulting in a complete loss of data for one subject. All other subjects were analyzed, with n = 24 HRV RMSSD data pairs sampled at random (n = 8 samples each from sleeping, resting, and moving activities) per subject when available.|||milliseconds||Standard Deviation|Mean
2533961|NCT03255824|Secondary|Hemodynamic Stability - Heart Rate|"To compare the differences in hemodynamic stability using a D/M combination compared to the MFP combination. (In this study, a deviation from baseline of both the blood pressure and heart rate by 20% or greater will be considered clinically significant)~a. Change in heart rate (change ≥ 20 BPM)"|During the procedure, up to 40 minutes||||beats per minute||Standard Deviation|Mean
2533917|NCT03257631|Primary|Percentage of Participants With an Objective Response or Long-term Stable Disease|Objective response and long-term stable disease rate was defined as the percentage of participants who achieved either an objective response, defined as a complete response (CR) or partial response (PR) in the first 6 cycles of treatment (or within 3 cycles for DIPG), or long-term stable disease (SD) defined as SD maintained for ≥ 6 cycles (≥ 3 cycles for DIPG), measured from first dose date. Disease assessments were based on magnetic resonance imaging (MRI) assessed by an independent central review. CR: Disappearance of all lesions and no new lesions. PR: A reduction of ≥ 50% in the size of measurable lesions compared to baseline, and/or persistence of non-target lesions with no progression or decrease in size. SD: A decrease of < 50% or an increase of < 25% in the size of measurable lesions and no evidence of new lesions, response does not meet the criteria for CR, PR, or progressive disease, and/or the persistence of non-target lesions with no progression or decrease in size.|6 months (first 6 cycles) or 3 months (first 3 cycles) for participants in the DIPG group|The response population consisted of all participants enrolled who met eligibility criteria relevant to efficacy, and received at least one cycle of pomalidomide if therapy was not discontinued earlier due to progressive disease (PD).|||percentage of participants||95% Confidence Interval|Number
2533918|NCT03257202|Primary|Number of Subjects With Positive Bacterial Growth Culture Per Treatment Arms|Detected presence of growth of Propionibacterium acnes on bacterial culture (bacteria per mL) by treatment arms.|21 days||||participants|||Number
2533919|NCT03257189|Primary|Number of Sensors That Remained Sufficiently Adhered to Subjects for 24 Hours as Assessed by a 5 Point Scale|The level of sensor adhesion will be assessed by a 5 point scale (0- sensor is greater than or equal to 90% of sensor adhered, 4-sensor completely detached from subject). Sensors receiving scores of 0 and 1 will be determined to have acceptable adhesion, while scores of 2, 3, and 4 will be considered unacceptable adhesion. The percentage of sensors which had acceptable adhesion at sensor removal is presented.|2 days after informed consent|All subjects analyzed, with 6 sensor locations per subject evaluated for adhesion to skin at device removal. Subjects wore n = 4 sensors (two sensors at chest and thigh locations required for algorithmic outputs, and one sensor at shank and one at forearm locations) on Day 1 and n = 2 sensors (chest and thigh algorithm location sensors) on Day 2.|||percent passing|Total Sensors Evaluated for Adhesion||Number
2533920|NCT03257189|Primary|Accuracy of Posture Classification as Compared to Visual Annotation|The device under test will classify a subjects activity into sleep posture, standing posture, and sitting posture as the subject performs various predefined activities, which are annotated by an observer. The device's Posture Classification will be compared to the observer's annotation. The percentage of correct classifications by the device against indicated visual observation is presented. The percent correct is not a per subject average, but is the percentage of all posture classifications which were correct when compared to ground truth observation.|2 days after informed consent|All subjects were analyzed, with each subject completing n = 5 repetitions of each sleeping / lying (supine, prone, lying left, lying right) and sitting / standing (upright, leaning backward, leaning forward, leaning left, leaning right) postures.|||percent correct|||Number
2533921|NCT03257189|Primary|Accuracy of Sleep Onset Time (Hours, Minutes, and Seconds), Sleep Wake Time (Hours, Minutes, and Seconds) as Compared to an Observer's Visual Annotation|Sleep onset and wake times as reported by the device under test will be compared to an observer's visual annotation of the sleep onset and wake times. The Mean Absolute Error (MAE) between times as indicated by the device and observed times is presented.|2 days after informed consent|All subjects were analyzed, with n = 2 sleep onset and n = 2 sleep wake times compared per subject against sleep technician observations|||minutes||Standard Deviation|Mean
2533922|NCT03257189|Primary|Accuracy of Step Count Compared to an Observer's Manual Count|The number of steps reported by the device under test during a 6 minute walk test will be compared to an observer's manual count of the number of steps taken.|2 days after informed consent|"All subjects performed n=5 six minute walk tests on a treadmill. Instances in which the system classified the subject as walking for at least 95% of the activity were analyzed. The study device step count was compared to the manually observed step count, with the percent error of each test calculated. These errors were averaged and are presented."|||percent error||Standard Deviation|Mean
2533923|NCT03257189|Primary|Accuracy of Activity Classification as Compared to Visual Annotation|The device under test will classify a subjects activity into sleeping, standing, sitting, lying, walking and other activities as the subject performs various predefined activities, which are annotated by an observer. The device's Activity Classification will be compared to the observer's annotation. The percentage of correct classifications by the device against indicated visual observation is presented. The percent correct is not a per subject average, but is the percentage of all activity classifications which were correct when compared to ground truth observation.|2 days after informed consent|"All subjects were analyzed, with classifications compared against n = 5 clinician observed one minute long activities (lying, sitting, standing, walking, and stationary biking for other classification) per subject. For analysis of sleep classification accuracy, n = 5 one minute long samples were sampled across both nights of sleep per subject."|||percent correct|||Number
2533924|NCT03257189|Primary|Accuracy of Respiration Rate Measured in Breaths Per Minute Compared to the Reference Device|Respiration rate as measured by the subject device in breaths per minute will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.|2 days after informed consent|All subjects were analyzed, with n = 8 total respiration rate data pairs sampled at random across the two nights of sleep per subject.|||breaths per minute||Standard Deviation|Mean
2533925|NCT03257189|Primary|Accuracy of Heart Rate Variability Measured by Low Frequency Content to High Frequency Content Ratio (HRV Ratio) Compared to the Reference Device|HRV Ratio as measured by the subject device determined by low frequency content to high frequency content ratio (HRV Ratio) in beats per minute will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.|2 days after informed consent|One comparator device malfunctioned, resulting in a complete loss of data for one subject. All other subjects were analyzed, with n = 24 HRV Ratio data pairs sampled at random (n = 8 samples each from sleeping, resting, and moving activities) per subject when available.|||unitless||Standard Deviation|Mean
2533962|NCT03255824|Secondary|Cooperation Scale|Surgeon satisfaction is measured by the Cooperation Scale. Minimum score of 0 and maximum of 9. Higher indicates a worse outcome (i.e., discomfort and movement)|15 minutes following surgery||||score on a scale||Standard Deviation|Mean
2533927|NCT03257189|Primary|Accuracy of Heart Rate Measured in Beats Per Minute Compared to Reference Device|Heart rate as measured by the subject device in beats per minute will be compared to the reference device. The Mean Absolute Error (MAE) between measurements from each device is presented.|2 days after informed consent|Once comparator device malfunctioned resulting in a complete loss of Heart Rate data for one subject. All other subjects were analyzed, with n = 24 HR data pairs sampled at random (n = 8 samples each from sleeping, resting, and moving activities) per subject when available.|||beats per minute||Standard Deviation|Mean
2533928|NCT03256968|Primary|FEV1 as a Measure of Lung Function|effect of ataluren on lung function as assessed by spirometry and measured by percentage of Liters (minimum value would be .0% Liters and maximum value of liters is dependent from person to person). The higher the value the better the outcome. The measure will include the change from baseline to one year to report a change between the two measurement points|1 year||||percentage of liters|||Number
2533929|NCT03256851|Primary|Daily Average Fatigue Interference Score|Rated on a 0-10 numerical rating scale, entered directly on the PRO-Diary (CamNTech, Cambridge, UK), which provides a more reliable and sensitive assay of symptoms compared to traditional recall measures.' A score of 0 indicates no interference while a score of 10 indicates complete interference (i.e., worse).|Baseline (pre) and 8 weeks (post)||||units on a scale||Standard Deviation|Mean
2533930|NCT03256851|Primary|Daily Average Fatigue Intensity Score|"Rated on a 0-10 numerical rating scale, entered directly on the PRO-Diary (CamNTech, Cambridge, UK), which provides a more reliable and sensitive assay of symptoms compared to traditional recall measures.~A score of 0 indicates no fatigue and a score of 10 indicates extremely severe fatigue."|Baseline (pre) and 8 weeks (post)||||units on a scale||Standard Deviation|Mean
2533931|NCT03256799|Primary|Lung Function|change in lung function as measured by spirometry|Baseline through 48 weeks||||Liters|||Number
2533932|NCT03256695|Secondary|Number of Participants With Adverse Events (AEs)|AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by investigator. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.|Baseline up to Week 12|ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.|||Participants|||Count of Participants
2533933|NCT03256695|Primary|Number of Albuterol Uses in the 24 Hours Preceding a CE-COPD|CE-COPD referred to occurrence of moderate or severe CE-COPD. Severe CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization for CE COPD. Moderate CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, an office visit, an urgent care visit, or an emergency care visit) for a CE-COPD, but not a hospitalization. Number of albuterol inhalations used in the 24 hours preceding a moderate or severe CE-COPD was reported.|Baseline to Week 12|ITT analysis set: all enrolled participants regardless of whether a participant took any IMP. Participants with CE-COPD during Day 1 to Day 7 were excluded. 'Overall number of participants analyzed' = participants who experienced at least 1 moderate or severe CE-COPD and reported albuterol use in the 24 hours preceding a moderate or severe CE-COPD.|||inhalations/24 hours||Standard Deviation|Mean
2533934|NCT03256695|Primary|Number of Days Prior to the Symptom Peak of a CE-COPD Event When Albuterol Use Increased|CE-COPD: occurrence of moderate or severe CE-COPD. Severe CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization. Moderate CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, an office visit, an urgent care visit, or an emergency care visit), but not a hospitalization. Number of days of increased albuterol use prior to the symptom peak of a CE-COPD was reported for first increase of daily albuterol use; 2 and 4 inhalations in a single day from baseline. increased daily albuterol use was defined as single-day increase of greater than (>) 20 percent (%) from baseline.|Baseline to Week 12|ITT analysis set: all enrolled participants regardless of whether a participant took any IMP. ‘Overall number of participants analyzed'= participants experiencing at least 1 moderate or severe CE-COPD. 'Number analyzed'=participants evaluable for specified categories. Participants with CE-COPD during Day 1 to Day 7 were excluded.|||days||Standard Deviation|Mean
2533935|NCT03256695|Primary|Total Number of Albuterol Inhalations in the Days Preceding the Symptom Peak of a CE-COPD Event|Severe CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization. Moderate CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, office visit, urgent care visit, or emergency care visit), but not a hospitalization. Total number of inhalations taken in 1 day(24-hour period on day prior to date of CE-COPD symptom peak) and at 3,5,7,10,14, and 21 days preceding the date of CE-COPD symptom peak were reported. If a participant experienced multiple CE-COPD events, number of inhalations preceding symptom peak of a subsequent event was counted since end of previous event. Average of inhalations of all events were presented.|Baseline to Week 12|ITT analysis set:all enrolled participants regardless of whether a participant took any IMP. Participants with CE-COPD during Day 1 to Day 7 were excluded. ‘Overall number of participants analyzed'= participants experiencing at least 1 moderate or severe CE-COPD.|||inhalations||Standard Deviation|Mean
2537972|NCT03118739|Other Pre-specified|Baseline MRI Variables - LV End-systolic Volume||Baseline|Total number differs from Study totals due to subject non compliance with MRI (exam not completed)|||mL||Standard Deviation|Mean
2533936|NCT03256695|Primary|Clinical Exacerbation of COPD (CE-COPD) Rate: Percentage of Participants Who Experienced at Least 1 Moderate or Severe CE-COPD|"CE-COPD was an occurrence of either severe CE-COPD or moderate CE-COPD. Severe CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with systemic corticosteroids (SCS; at least 10 milligrams [mg] prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization for CE COPD.~Moderate CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, an office visit, an urgent care visit, or an emergency care visit) for a CE-COPD, but not a hospitalization."|Baseline (Day 1) to Week 12|ITT analysis set included all enrolled participants regardless of whether a participant took any IMP. Participants with CE-COPD during study Day 1 through study Day 7 were excluded from the analysis.|||percentage of participants|||Number
2533937|NCT03256552|Secondary|FVC AUC0-2|Change from Baseline in FVC AUC0-2 on Day 8 normalized for length of follow-up. FVC was measured at 15 min, 30 min, 1 hour, and 2 hours post dose.|Baseline, Day 8|MITT Population defined as all subjects who received treatment and had post-treatment efficacy data from at least two treatment periods.|||Liters||95% Confidence Interval|Least Squares Mean
2533938|NCT03256552|Secondary|Peak Change in FEV1|Peak Change from Baseline in FEV1|Day 1 and Day 8|MITT Population defined as all subjects who received treatment and had post-treatment efficacy data from at least two treatment periods.|||Liters||95% Confidence Interval|Least Squares Mean
2533939|NCT03256552|Secondary|FEV1 AUC0-2|Change from Baseline in FEV1 AUC0-2 normalized for length of follow-up. FEV1 was measured at 15 min, 30 min, 1 hour, and 2 hours post dose.|Day 1 and Day 8|MITT Population defined as all subjects who received treatment and had post-treatment efficacy data from at least two treatment periods.|||Liters||95% Confidence Interval|Least Squares Mean
2533940|NCT03256552|Primary|Morning Pre-dose Trough FEV1|Change from Baseline in Morning Pre-dose Trough FEV1|Baseline, Day 8|MITT Population defined as all subjects who received treatment and had post-treatment efficacy data from at least two treatment periods.|||Liters||95% Confidence Interval|Least Squares Mean
2533941|NCT03256526|Secondary|Number of Participants With Laboratory Abnormalities|Below parameters were evaluated for laboratory tests: Hemoglobin, Hematocrit, Erythrocytes, Ery. Mean Copuscular Volume, Ery. Mean Copuscular Hemoglobin, Ery. Mean Corpuscular HGB Concentration, Platelets, Leukocytes, Lymphocytes, Neuprophils, Basophils, Eosinophils, Monocytes, Bilirubin, Direct Biliirubin, Indirect Bilirubin, Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase, Protein, Albumin, Albumin, Blood Urea Nitrogen, Creatinine, Urate, Sodium, Potassium, Chloride, Calcium, Bicarbonate, Glucose-Fasting, pH, Urine Glucose, Ketone, Urine Protein, Urine Hemoglobin, Urobilinogen, Urine Bilirubin, Nitrite, Leukocyte Esterase, Urine Erythocytes, Urine leukocytes, Hyaline Casts, Urine Creatinine.|Baseline up to Day 56 (Week 8)|The analysis population included participants with at least 1 observation of the given laboratory test while on study treatment.|||Participants|||Count of Participants
2533942|NCT03256526|Secondary|Number of Participants With Post-dose ECG Data Meeting Categorical Criteria|"The ECG categorical criteria included:~PR Interval (msec) percent (%)Change >= 25% increase when baseline >200 or >=50% increase when baseline <=200 QRS Interval (msec) %Change >= 50% increase QTcF Interval (Fridericia's Correction) (msec) increase 30 <= Change < 60 or Change >= 60 PR Interval (msec) Value >= 300 QRS Interval (msec) Value >= 140 QTcF Interval (Fridericia's Correction) (msec) 450 <= Value <480 or 480 <=Value <500 or Value >= 500"|Baseline up to Day 56 (Week 8)|The analysis population included all participants who received at least 1 dose of investigational product and were evaluated against the criteria.|||Participants|||Count of Participants
2533943|NCT03256526|Secondary|Number of Participants With Post-dose Vital Signs Data Meeting Categorical Criteria|"The vital sign categorical criteria included:~Sitting DBP (diastolic blood pressure) millimeter of mercury (mmHg) Change >= 20 mmHg increase Sitting SBP (systolic blood pressure) (mmHg) Change >= 30 mmHg increase Sitting DBP (mmHg) Change >= 20 mmHg decrease Sitting SBP (mmHg) Change >= 30 mmHg decrease Sitting DBP (mmHg) Value < 50 mmHg Sitting Pulse Rate (bpm) Value < 40 bpm or Value > 120 bpm Sitting SBP (mmHg) Value < 90 mmHg"|Baseline up to Day 56 (Week 8)|The analysis population included all participants who received at least 1 dose of investigational product and were evaluated against the criteria.|||Participants|||Count of Participants
2533944|NCT03256526|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|"All-causality adverse events (AEs) were any untoward medical occurrence in a study participant who administered a product or medical device, the event need not necessarily have a causal relationship with the treatment or usage. Treatment-related AEs were any untoward medical occurrence in a study participant who administered a product or medical device, the event needed to have a causal relationship with the treatment or usage.~A TEAE was defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments."|Baseline up to Day 77 (28-35 days post last dose)|The safety analysis population included all participants who received at least 1 dose of investigational product.|||Participants|||Count of Participants
2533945|NCT03256526|Primary|Percent Change From Baseline in Whole Liver Fat at Week 6|"The percent change from baseline in whole liver fat at Week 6 was assessed by magnetic resonance imaging proton density fat fraction (MRI-PDFF).~MRI-PDFF generates measures of the fraction of mobile protons in the liver attributable to fat content and provides whole liver coverage so that fat content can be assessed across 8 Couinaud liver segments. Whole liver PDFF was calculated as follows:~Whole Liver PDFF= PDFFs for (Segment I+Segment II+Segment III+Segment IVa+Segment IVb+Segment V+Segment VI+Segment+VII+Segment VIII) / (number of segments assessed).~The same segments were to be used at both baseline and post-baseline time points in the calculation of whole liver PDFF to derive the percent change from baseline.~The values of whole liver PDFF ranges from 0 to 100 and higher values represent higher liver fat."|Baseline and Week 6|The efficacy analysis population was defined as all randomized participants who received at least 1 dose of randomized treatment and assessed by MRI-PDFF at Week 6.|||Percent Change||Standard Deviation|Mean
2533959|NCT03255824|Secondary|Respiratory Depression - Respiratory Rate|"To assess whether a D/M combination leads to a significant change in respiratory depression compared to the MFP combination.~a. Change in respiratory rate (change ≥ 20%)"|During the procedure, up to 40 minutes||||breaths per minute||Standard Deviation|Mean
2539141|NCT03079375|Primary|Admissions|number of patients who have been admitted|180 days||||Participants|||Count of Participants
2533946|NCT03256162|Secondary|The Montreal Cognitive Assessment (MoCA)|"The MOCA was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, conceptual thinking, calculations, and orientation. It is scored out of a maximum of 30. The higher scores indicate better cognition.~The MOCA will be performed at baseline, one day after infusions 1 and 4 and 12 weeks after the final infusion."|15 weeks||||score on a scale||Standard Deviation|Mean
2533947|NCT03256162|Secondary|The Patient-Rated Inventory of Side Effects (PRISE)|"The PRISE will be used to document other general adverse events by patients before, during and after infusions. This is a patient self-report used to qualify side effects by identifying and evaluating the tolerability of each symptom. It is a 9 item assessment of the side effects in the following symptom domains; Gastrointestinal, Heart, Skin, Nervous System, Eyes/Ears, Genital/Urinary, Sleep, Sexual Functioning, and Other. Each domain has multiple symptoms which can be endorsed. For each domain the patient rates whether or not the symptoms are tolerable or distressing. Data below represent the number of participants from which there was an endorsement of each listed event.~Participants will have the PRISE performed before, during (+30mins) and after (+60mins) each of the four once-weekly infusions."|4 weeks||||participants|||Number
2533948|NCT03256162|Secondary|Young Mania Rating Scale (YMRS; Mood Item)|"Investigators will use the mood item of them YMRS to assess for psychotomimetic effects. This item is rated 0-4. The higher scores reflect elevated mood.~Participants will have the YMRS performed before, during (+30mins) and after (+60mins) each of the four once-weekly infusions."|4 weeks||||score on a scale||Standard Deviation|Mean
2533949|NCT03256162|Secondary|The Brief Psychiatric Rating Scale (BPRS)|"The BPRS measures psychotomimetic effects. The investigators will use the positive symptoms subscale of the Brief Psychiatric Rating Scale. The 4-item positive symptoms subscale measures suspiciousness, hallucinations, unusual thought content, and conceptual disorganisation. Each question is scored between 0-7. The maximum score in this 4-item questionnaire is 28. Higher scores indicate more severe psychotic symptoms.~Participants will have the BPRS performed before, during (+30mins) and after (+60mins) each of the four once-weekly infusions."|4 weeks||||score on a scale||Standard Deviation|Mean
2533950|NCT03256162|Secondary|The Clinician-Administered Dissociative States Scale (CADSS)|"The CADSS measures dissociative symptoms. It will be administered before, during and after infusions in order to capture the range of possible subjective side effects of either agent. This consists of 23 questions and scores for each question range from 0-4. The maximum score is 92 with higher scores indicating more dissociative symptoms.~Participants will have the CADSS performed before, during (+30mins) and after (+60mins) each of the four once-weekly infusions."|4 weeks||||score on a scale||Standard Deviation|Mean
2533951|NCT03256162|Secondary|The Quick Inventory of Depressive Symptoms, Self-report Version (QIDS-SR16)|"The QIDS-SR16 is a validated self-report measure of depressive symptoms. This consists of 16 questions rated 0-3. Its score range is 0-48, with higher scores reflecting greater burden of depressive symptoms.~Participants will have a baseline (T0) QIDS-SR16 score. This will be repeated one week after each of four once-weekly infusions (T1-4) and follow-up measures after another five (T9) and 11 (T15) weeks. Week 15 scores are reported."|15 weeks||||score on a scale||95% Confidence Interval|Mean
2533952|NCT03256162|Primary|The Hamilton Rating Scale for Depression-24 Item Version (HRSD-24)|"The HRSD assesses severity of depressive symptoms and is commonly used to measure depression severity. It was initially a 17-item format with the optional addition of 4 items making up the 21-item version. In addition to the original 21 items, the 24-item HRSD includes items on helplessness, hopelessness and worthlessness; its score range is 0-77, with higher scores reflecting greater burden of depressive symptoms.~Response to antidepressant treatment is defined as achieving ≥60% decrease from baseline HRSD-24 and score ≤16. Remission criteria are ≥60% decrease in HRSD from baseline and score ≤10. Criteria for relapse are ≥10 point increase in HRSD-24 compared to responder baseline score plus HRSD ≥16; in addition, increase in the HRSD should be maintained one week later.~Participants will have a baseline (T0) HRSD-24 score. This will be repeated 1 week after each of 4 once-weekly infusions (T1-4) and follow-up measures after another 5 (T9) and 11 (T15) weeks, week 15 is reported."|15 weeks||||score on a scale||95% Confidence Interval|Mean
2533953|NCT03255902|Secondary|Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value|3-month Hemoglobin A1c value subtracted from pre-intervention Hemoglobin A1c value. Positive numbers indicate an improvement in glucose control with intervention, and negative numbers indicate no improvement in glucose control with intervention.|Pre intervention to 3 months post intervention|2 participants did not complete study|||percent of HbA1c||Full Range|Median
2533954|NCT03255902|Primary|Effect of Intervention on Evening Glucose Control.|Number of families whose child achieved a decrease overnight between bedtime blood glucose level and morning fasting glucose level following intervention at 6 weeks.|After 6 weeks of classes|2 participants did not complete study|||Participants|||Count of Participants
2533955|NCT03255824|Secondary|Postoperative Recovery Time - Time to Discharge|"To assess whether a D/M combination increases postoperative recovery time when compared the MFP combination.~a. Time to discharge or virtual discharge (comparative statistic) - Aldrete score of ≥ 9 or pre-procedure score is met The minimum score is 0 and the maximum score is 10. A higher score indicates wakefulness, hemodynamically stable, and able to ambulate.~ii. All subjects are required to stay a minimum of 30 minutes after the end of the procedure. Therefore, at least two postoperative vital sign readings will be obtained. If the subject meets discharge criteria prior to 30 minutes, this time will be the virtual discharge time"|After the procedure until discharge, up to 45 minutes||||minutes||Standard Deviation|Mean
2533956|NCT03255824|Secondary|Postoperative Recovery Time - Ambulation|"To assess whether a D/M combination increases postoperative recovery time when compared the MFP combination.~a. Time to ambulation (to recovery room) will be recorded"|After the procedure until ambulation, up to 20 minutes||||minutes||Standard Deviation|Mean
2533957|NCT03255824|Secondary|Postoperative Recovery Time - Duration of Procedure|"To assess whether a D/M combination increases postoperative recovery time when compared the MFP combination.~a. Duration of procedure will be recorded"|During the procedure, up to 40 minutes||||MINUTES||Standard Deviation|Mean
2533958|NCT03255824|Secondary|Respiratory Depression - Oxygen Saturation|"To assess whether a D/M combination leads to a significant change in respiratory depression compared to the MFP combination.~a. Change in arterial oxygen saturation (as measured by pulse oximeter) i. number of events of ≤92%"|During the procedure, up to 40 minutes||||Saturation percent||Standard Deviation|Mean
2533965|NCT03255824|Secondary|Reaction to Administration of Local Anesthesia|"To compare the groups regarding movement of the patient during the first injection of local anesthesia during the IVS at time of injection measured using the Behavioral Pain Scale - Non-Intubated patients.~The minimum value is 3 and the maximum value is 12. Higher scores mean a worse outcome (i.e., more pain and movement on injection)"|During the first injection of local anesthesia during surgery||||score on a scale||Standard Deviation|Mean
2533966|NCT03255824|Primary|Respiratory Events Requiring Intervention|To compare the groups regarding the number of respiratory events requiring intervention, described as: Chin lift/jaw thrust, Tongue thrust, Yankauer suctioning, Positive pressure oxygen administration, Placement of an oral or nasal airway.|During surgery||||Participants|||Count of Participants
2533967|NCT03255733|Secondary|Average Pain Score Change as Reported Using Patient Rated Tennis Elbow Evaluation, During Normal Activities|Average Percentage of Pain Change as Reported using Patient-Rated Tennis Elbow Evaluation Survey, compared to baseline. Range (± 100%)|12 weeks after 1st Treatment||||percentage of reported pain change||Full Range|Mean
2533968|NCT03255733|Primary|Percentage of Patients Reporting at Least 25% Overall Pain Reduction|Percentage of Patients Reporting at least 25% pain reduction compared to baseline, using Universal Visual Analog Scale (VAS) Pain Score. VAS is a 10-point Pain Scale, where 0 = No Pain, 1 = Slight Pain and 10 = the Patients Worst Imaginable Pain. Scales in between represent 10% increments of Pain ( Range 1 - 10).|12 weeks after 1st Treatment|Percentage of Patients reporting at least 25% improvement in Pain at 12 Weeks after the first treatment|||percentage of patients with less pain|||Number
2533969|NCT03255655|Primary|Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging|Mean Percentage Change in Volume of Plantar Fascia Hypoechoic Lesions by Diagnostic Ultrasound Imaging compared to Baseline Volume, where volume is calculated using: (4/3)π x R1 x R2 x R3, where R = Radius of each measurement: Lesion Length (1), Width (2), Depth (3).|12 Weeks after the first Treatment|Male and Female previously diagnosed with Chronic Plantar Fasciitis, between the age of 18 and 85.|||percentage of Hypoechoic Lesion Change||Standard Error|Mean
2533970|NCT03255655|Primary|Average Percentage of Change as Reported Using Foot Function Index Pain Subscale|Average Percentage of Change as Reported using Foot Function Index (FFI) pain subscale. Range (±100%). Foot Function Index pain subscale is a measure of pain and disability and activity limitation based 9 questions, each with a possible pain score of 0 - 10, where 0 indicates no pain during the described activity and 10 indicates the worst imaginable pain during a described activity. A summed total score of 0 indicates the patient had no pain for all activities. A score of 90 indicates the patient experiences the worst imaginable pain for all the described activities. The results compare the average percentage change of the FFI score at 12 weeks, compared to the average FFI score at baseline.|12 weeks after 1st Treatment|Total population of respondents at 12 weeks.|||percentage of Change||Full Range|Mean
2533971|NCT03255382|Secondary|Participants With Baseline NAPSI ˃0: Change From Baseline to Week 24|The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 24|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533972|NCT03255382|Secondary|Participants With Baseline NAPSI ˃0: Change From Baseline to Week 16|The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 16|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533973|NCT03255382|Secondary|NAPSI: Change From Baseline to Week 24|The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 24|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533974|NCT03255382|Secondary|Nail Psoriasis Severity Index (NAPSI): Change From Baseline to Week 16|The NAPSI score is calculated by summing the scores of all the nails which for each nail are the sum of the nail matrix score and nail bed score. Each of these is scored as 0=none, 1=present in 1/4 nail, 2=present in 2/4 nail, 3=present in 3/4 nail, 4=present in 4/4 nail. Each nail has a matrix score (0-4) and a nail bed score (0-4). The total nail score is the sum of those 2 (nail matrix and nail bed) individual scores (0-8). The sum of the total score of all involved fingernails is then the total NAPSI score. The NAPSI score is calculated only if all questions in the case report form are completed. A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 16|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533975|NCT03255382|Secondary|EQ-5D-5L VAS: Change From Baseline to Week 24|The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale numbered from 100 (best health imagined) to 0 (worst health imagined). The VAS score from the scale is then entered as a number by the participant. This can be used as a quantitative measure of health outcome that reflects the participant's own judgement. An increase in the EQ-5D-5L VAS score indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 24|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533976|NCT03255382|Secondary|EQ-5D-5L Visual Analog Scale (VAS): Change From Baseline to Week 16|The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L VAS records the participant's self-rated health on a vertical visual analogue scale numbered from 100 (best health imagined) to 0 (worst health imagined). The VAS score from the scale is then entered as a number by the participant. This can be used as a quantitative measure of health outcome that reflects the participant's own judgement. An increase in the EQ-5D-5L VAS score indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 16|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533977|NCT03255382|Secondary|EQ-5D-5L Total Score: Change From Baseline to Week 24|The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 24|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533978|NCT03255382|Secondary|European Quality of Life 5 Dimensions (EQ-5D-5L) Total Score: Change From Baseline to Week 16|The EQ-5D-5L is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 16|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533979|NCT03255382|Secondary|PSSI: Change From Baseline at Week 24|The physician assessed the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved). The composite score is calculated as the sum of symptom scores multiplied by the score for the area of scalp involved. The PSSI ranges from 0 (best) to 72 (worst). A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 24|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533980|NCT03255382|Secondary|Psoriasis Scalp Severity Index (PSSI): Change From Baseline at Week 16|The physician assessed the severity of scalp psoriasis using the PSSI, which consists of an assessment of erythema, induration, and desquamation on a scale from 0 (none) to 4 (very severe) and the percentage of scalp involved on a scale from 0 (0% of scalp involved) to 6 (90-100% of scalp involved). The composite score is calculated as the sum of symptom scores multiplied by the score for the area of scalp involved. The PSSI ranges from 0 (best) to 72 (worst). A negative change from Baseline indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 16|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533981|NCT03255382|Secondary|DLQI: Change From Baseline to Week 24|The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. LOCF imputation was used for missing data.|Baseline, Week 24|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533982|NCT03255382|Secondary|DLQI Total Score: Change From Baseline to Week 16|The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. LOCF imputation was used for missing data.|Baseline, Week 16|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533983|NCT03255382|Secondary|Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 24|The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.|Week 24|ITT analysis set|||percentage of participants|||Number
2534014|NCT03255382|Secondary|Percentage of Participants Achieving sPGA Score of Clear at Week 12|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 12|ITT analysis set|||percentage of participants|||Number
2533984|NCT03255382|Secondary|Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16|The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.|Week 16|ITT analysis set|||percentage of participants|||Number
2533985|NCT03255382|Secondary|HADS Total Score-Depression: Change From Baseline to Week 24|The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.|Baseline, Week 24|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533986|NCT03255382|Secondary|HADS Total Score-Depression: Change From Baseline to Week 16|The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.|Baseline, Week 16|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533987|NCT03255382|Secondary|HADS Total Score-Anxiety: Change From Baseline to Week 24|The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.|Baseline, Week 24|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533988|NCT03255382|Secondary|Hospital Anxiety & Depression Scale (HADS) Total Score-Anxiety: Change From Baseline to Week 16|The HADS was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. LOCF imputation was used for missing data.|Baseline, Week 16|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533989|NCT03255382|Secondary|PtGA: Change From Baseline to Week 24|"The PtGA is a patient-reported outcome instrument to assess the patient's assessment of disease severity. This self-reported measure is used to assess disease activity using a 4-point scale where a higher score indicates a higher level of disease activity. Disease activity is assessed from 0 (complete disease control) to 3 (uncontrolled disease). LOCF imputation was used for missing data."|Baseline, Week 24|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533990|NCT03255382|Secondary|Patient's Global Assessment (PtGA): Change From Baseline to Week 16|"The PtGA is a patient-reported outcome instrument to assess the patient's assessment of disease severity. This self-reported measure is used to assess disease activity using a 4-point scale where a higher score indicates a higher level of disease activity. Disease activity is assessed from 0 (complete disease control) to 3 (uncontrolled disease). LOCF imputation was used for missing data."|Baseline, Week 16|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533991|NCT03255382|Secondary|SF-36 V2 MCS Score: Change From Baseline to Week 24|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 24|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533992|NCT03255382|Secondary|SF-36 V2 Mental Component Summary (MCS) Score: Change From Baseline: to Week 16|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 16|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533993|NCT03255382|Secondary|SF-36 V2 PCS Score: Change From Baseline to Week 24|The SF-36 V2 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 24|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533994|NCT03255382|Secondary|Short Form Health Survey 36, Version 2 (SF-36 V2) Physical Component Summary (PCS) Score: Change From Baseline to Week 16|The SF-36 V2 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 16|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2533995|NCT03255382|Secondary|BSA Affected by Psoriasis: Change From Baseline to Week 24|BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 24|ITT analysis set.|||percentage estimated body surface area||Standard Error|Least Squares Mean
2533996|NCT03255382|Secondary|BSA Affected by Psoriasis: Change From Baseline to Week 20|BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 20|ITT analysis set.|||percentage estimated body surface area||Standard Error|Least Squares Mean
2533997|NCT03255382|Secondary|BSA Affected by Psoriasis: Change From Baseline to Week 16|BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 16|ITT analysis set.|||percentage estimated body surface area||Standard Error|Least Squares Mean
2533998|NCT03255382|Secondary|BSA Affected by Psoriasis: Change From Baseline to Week 12|BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 12|ITT analysis set.|||percentage estimated body surface area||Standard Error|Least Squares Mean
2533999|NCT03255382|Secondary|BSA Affected by Psoriasis: Change From Baseline to Week 8|BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 8|ITT analysis set.|||percentage estimated body surface area||Standard Error|Least Squares Mean
2534000|NCT03255382|Secondary|Body Surface Area (BSA) Affected by Psoriasis: Change From Baseline to Week 4|BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement. LOCF imputation was used for missing data.|Baseline, Week 4|ITT analysis set.|||percentage estimated body surface area||Standard Error|Least Squares Mean
2534001|NCT03255382|Secondary|PPASI: Change From Baseline to Week 24|The PPASI is an assessment by the investigator that provides a numeric scoring for psoriasis affecting the hands and feet with scores ranging from 0 to 72. It is a linear combination of percent of surface area of palms and soles that are affected and the severity of erythema, induration, and desquamation. The higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.|Baseline, Week 24|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2534002|NCT03255382|Secondary|Palmoplantar Psoriasis Severity Index (PPASI): Change From Baseline to Week 16|The PPASI is an assessment by the investigator that provides a numeric scoring for psoriasis affecting the hands and feet with scores ranging from 0 to 72. It is a linear combination of percent of surface area of palms and soles that are affected and the severity of erythema, induration, and desquamation. The higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.|Baseline, Week 16|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2534003|NCT03255382|Secondary|NAPPA-CLIN Total Score: Change From Baseline to Week 24|The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the NAPSI score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data.|Baseline, Week 24|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2534015|NCT03255382|Secondary|Percentage of Participants Achieving sPGA Score of Clear at Week 8|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 8|ITT analysis set|||percentage of participants|||Number
2537973|NCT03118739|Other Pre-specified|Baseline MRI Variables - LV Ejection Fraction||Baseline|Total number differs from Study totals due to subject non compliance with MRI (exam not completed)|||% (percentage of LV volume)||Standard Deviation|Mean
2534004|NCT03255382|Secondary|Clinical Severity of Nail Psoriasis (NAPPA-CLIN) Total Score: Change From Baseline to Week 16|The NAPPA-CLIN is an investigator assessment used to assess the severity of nail matrix psoriasis (leukonychia, red spots, dots, nail plate crumbling) and psoriasis of the nail bed (oil drop, splinter haemorrhage, subungual hyperkeratosis, onycholysis). NAPPA-CLIN has been developed from the Nail Psoriasis Severity Index (NAPSI) score, a nail psoriasis-specific score, which in its original version comprises the assessment of matrix and nail bed involvement in every finger and toe by 2 criteria for each nail. The NAPPA-CLIN is a simplified version of the NAPSI which only assesses the least and the worst involved nail of both hands or both feet respectively. Thus, the NAPPA-CLIN scores for hands or feet range from 0 to 16. A higher score indicates a worse involvement. LOCF imputation was used for missing data.|Baseline, Week 16|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2534005|NCT03255382|Secondary|Summary of PBI at Week 24|"The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment. The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment.The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (PNQ). After treatment, the participant rates the degree of benefits achieved (PBQ). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for did not apply to me (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data."|Baseline Week 24|ITT analysis set.|||units on a scale||Standard Deviation|Mean
2534006|NCT03255382|Secondary|Summary of Patient Benefit Index (PBI) at Week 16|"The PBI is a patient-reported outcome instrument that assesses the benefit of psoriasis treatment.The PBI assessment consists of 2 steps: before treatment, every participant defines his/her treatment needs according to a standardized list (Patient Needs Questionnaire [PNQ]). After treatment, the participant rates the degree of benefits achieved (Patient Benefits Questionnaire [PBQ]). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for did not apply to me (5) and missing. For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score. An increase in PBI indicates improvement. LOCF imputation was used for missing data."|Baseline, Week 16|ITT analysis set.|||units on a scale||Standard Deviation|Mean
2534007|NCT03255382|Secondary|PSS Total Score: Change From Baseline to Week 24|The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.|Baseline, Week 24|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2534008|NCT03255382|Secondary|PSS Total Score: Change From Baseline to Week 16|The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. LOCF imputation was used for missing data.|Baseline, Week 16|ITT analysis set.|||units on a scale||Standard Error|Least Squares Mean
2534009|NCT03255382|Secondary|Percentage of Participants With PSS Score of 0 at Week 24|The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.|Week 24|ITT analysis set|||percentage of participants|||Number
2534010|NCT03255382|Secondary|Percentage of Participants With Psoriasis Symptoms Scale (PSS) Score of 0 at Week 16|The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.|Week 16|ITT analysis set|||percentage of participants|||Number
2534011|NCT03255382|Secondary|Percentage of Participants Achieving sPGA Score of Clear at Week 24|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 24|ITT analysis set|||percentage of participants|||Number
2534012|NCT03255382|Secondary|Percentage of Participants Achieving sPGA Score of Clear at Week 20|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 20|ITT analysis set|||percentage of participants|||Number
2534013|NCT03255382|Secondary|Percentage of Participants Achieving sPGA Score of Clear at Week 16|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 16|ITT analysis set|||percentage of participants|||Number
2534071|NCT03255187|Secondary|Insulin Resistance|The biomarker of insulin resistance is measured, calculated by fasting glucose and fasting insulin using the formula of [fasting insulin (mU/L) × fasting glucose (mmol/L)]/22.5. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.|Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.||||mmol/L × mU/L||Standard Deviation|Mean
2534016|NCT03255382|Secondary|Percentage of Participants Achieving sPGA Score of Clear at Week 4|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 4|ITT analysis set|||percentage of participants|||Number
2534017|NCT03255382|Secondary|Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 24|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 24|ITT analysis set.|||percentage of participants|||Number
2534018|NCT03255382|Secondary|Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 20|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 20|ITT analysis set.|||percentage of participants|||Number
2534019|NCT03255382|Secondary|Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 16|ITT analysis set.|||percentage of participants|||Number
2534020|NCT03255382|Secondary|Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 12|ITT analysis set.|||percentage of participants|||Number
2534021|NCT03255382|Secondary|Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 8|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 8|ITT analysis set.|||percentage of participants|||Number
2534022|NCT03255382|Secondary|Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 4|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 4|ITT analysis set.|||percentage of participants|||Number
2534023|NCT03255382|Secondary|PASI: Change From Baseline to Week 24|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.|Baseline, Week 24|ITT analysis set|||units on a scale||Standard Error|Least Squares Mean
2534024|NCT03255382|Secondary|PASI: Change From Baseline to Week 20|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.|Baseline, Week 20|ITT analysis set|||units on a scale||Standard Error|Least Squares Mean
2534025|NCT03255382|Secondary|PASI: Change From Baseline to Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.|Baseline, Week 16|ITT analysis set|||units on a scale||Standard Error|Least Squares Mean
2534026|NCT03255382|Secondary|PASI: Change From Baseline to Week 12|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.|Baseline, Week 12|ITT analysis set|||units on a scale||Standard Error|Least Squares Mean
2534101|NCT03252964|Secondary|Average Age of Participants Who Complete Trial (Yrs)|(Sum of age of patients who complete)/(Total number who complete)|up to six months|Lack of study resources to collect sufficient data on outcome variable.||||||
2539142|NCT03079375|Primary|Readmissions|number of patients who have been readmitted|30 days||||Participants|||Count of Participants
2534027|NCT03255382|Secondary|PASI: Change From Baseline to Week 8|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. LOCF imputation was used for missing data.|Baseline, Week 8|ITT analysis set|||units on a scale||Standard Error|Least Squares Mean
2534028|NCT03255382|Secondary|Psoriasis Area and Severity Index (PASI): Change From Baseline to Week 4|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. Last observation carried forward (LOCF) imputation was used for missing data.|Baseline, Week 4|ITT analysis set|||units on a scale||Standard Error|Least Squares Mean
2534029|NCT03255382|Secondary|Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 24|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 24|ITT analysis set|||percentage of participants|||Number
2534030|NCT03255382|Secondary|Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 20|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 20|ITT analysis set|||percentage of participants|||Number
2534031|NCT03255382|Secondary|Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 16|ITT analysis set|||percentage of participants|||Number
2534032|NCT03255382|Secondary|Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 12|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 12|ITT analysis set|||percentage of participants|||Number
2534033|NCT03255382|Secondary|Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 8|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 8|ITT analysis set|||percentage of participants|||Number
2534034|NCT03255382|Secondary|Percentage of Participants Achieving 100% Improvement in PASI (PASI100) at Week 4|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 4|ITT analysis set|||percentage of participants|||Number
2534059|NCT03255291|Secondary|Effect of the Intervention on Physical Activity Levels as Measured by Recovery Self-efficacy|"Recovery Self-efficacy is defined as being sure one can re-engage in physical activity after putting it off~Measured on a 4 point Likert Scale (range: 1=lower recovery Self-efficacy to 4=higher recovery Self-efficacy)~Higher recovery self-efficacy is considered a better outcome~Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items"|90 days|Due to the limitations of data collection & concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related recovery self-efficacy among participants who engaged in the exercise-related mental imagery condition.|||score on a scale||Standard Error|Mean
2534035|NCT03255382|Secondary|Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 20|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 20|ITT analysis set|||percentage of participants|||Number
2534036|NCT03255382|Secondary|Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 16|ITT analysis set|||percentage of participants|||Number
2534037|NCT03255382|Secondary|Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 12|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 12|ITT analysis set|||percentage of participants|||Number
2534038|NCT03255382|Secondary|Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 8|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 8|ITT analysis set|||percentage of participants|||Number
2534039|NCT03255382|Secondary|Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 4|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 4|ITT analysis set|||percentage of participants|||Number
2534040|NCT03255382|Secondary|Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 24|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 24|ITT analysis set.|||percentage of participants|||Number
2534041|NCT03255382|Secondary|Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 20|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 20|ITT analysis set.|||percentage of participants|||Number
2534042|NCT03255382|Secondary|Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 16|ITT analysis set.|||percentage of participants|||Number
2534102|NCT03252964|Secondary|Average Age of Participants Who Start Trial (Yrs)|(Sum of ages of all enrollees)/(Total number of enrollees)|up to three months|Lack of study resources to collect adequate information on this variable.||||||
2534043|NCT03255382|Secondary|Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 12|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 12|ITT analysis set.|||percentage of participants|||Number
2534044|NCT03255382|Secondary|Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 8|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 8|ITT analysis set.|||percentage of participants|||Number
2534045|NCT03255382|Secondary|Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 4|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 4|ITT analysis set.|||percentage of participants|||Number
2534046|NCT03255382|Secondary|Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 24|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 24|ITT analysis set.|||percentage of participants|||Number
2534047|NCT03255382|Secondary|Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 20|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 20|ITT analysis set.|||percentage of participants|||Number
2534048|NCT03255382|Secondary|Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 16|ITT analysis set.|||percentage of participants|||Number
2534049|NCT03255382|Secondary|Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 12|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 12|ITT analysis set.|||percentage of participants|||Number
2534050|NCT03255382|Secondary|Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 8|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 8|ITT analysis set.|||percentage of participants|||Number
2534103|NCT03252964|Secondary|Change in Medication Dosage (mg/Day; U/Day)|(dosage of Rx on Day 180)-(dosage of Rx on Day 0)|up to six months|Lack of study resources to collect adequate information on this variable.||||||
2534051|NCT03255382|Secondary|Percentage of Participants Achieving 50% Improvement in PASI Score (PASI50) at Week 4|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 4|ITT analysis set|||percentage of participants|||Number
2534052|NCT03255382|Primary|Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) at Week 24|The Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data.|Week 24|Intent to Treat (ITT) analysis set: all participants who were randomized.|||percentage of participants|||Number
2534053|NCT03255291|Secondary|Effect of the Intervention on Physical Activity Levels as Measured by Action Self-efficacy|"Action self-efficacy is defined as having the confidence to engage in physical activity~Measured on a 4 point Likert Scale (range: 1=lower Action Self-efficacy to 4=higher Action Self-efficacy)~Higher Action Self-efficacy is considered a better outcome~Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items"|90 days|Due to the limitations of data collection and concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related action self-efficacy among participants who engaged in the exercise-related mental imagery condition.|||score on a scale||Standard Error|Mean
2534054|NCT03255291|Secondary|Effect of the Intervention on Physical Activity Levels as Measured by Coping Planning|"Coping planning is defined as having a detailed plan of solving problems that may prevent getting adequate physical activity~Measured on a 4 point Likert Scale (range: 1=lower Coping Planning to 4=higher Coping Planning)~Higher coping planning is considered a better outcome~Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items"|90 days|Due to the limitations of data collection and concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related coping planning among participants who engaged in the exercise-related mental imagery condition.|||score on a scale||Standard Error|Mean
2534055|NCT03255291|Secondary|Effect of the Intervention on Physical Activity Levels as Measured by Action Planning|"Action planning is defined as having a detailed plan about getting adequate physical activity~Measured as an average of three variables measured on a 4 point Likert Scale (range: 1=lower action planning to 4=higher action planning)~Higher action planning is considered a better outcome~Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items"|90 days|Due to the limitations of data collection and concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related action planning among participants who engaged in the exercise-related mental imagery condition.|||score on a scale||Standard Error|Mean
2534056|NCT03255291|Secondary|Effect of the Intervention on Physical Activity Levels as Measured by Perceived Vividness of Self-regulatory Imagery|"Perceived Vividness of Self-regulatory Imagery is defined as having clear and vivid images of steps towards getting physical activity~Measured as an average of two variables measured on a 4 point Likert Scale (range: 1=lower Perceived Vividness of Self-regulatory Imagery to 4=higher Perceived Vividness of Self-regulatory Imagery)~Higher Perceived Vividness of Self-regulatory Imagery is considered a better outcome~Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items"|90 days|Due to the limitations of data collection and concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related perceived vividness of self-regulatory imagery among participants who engaged in the exercise-related mental imagery condition.|||score on a scale||Standard Error|Mean
2534057|NCT03255291|Secondary|Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Thinking Behavior is Unpleasant|"Affective Attitudes to Exercise - Thinking Behavior is Unpleasant is defined as not thinking getting regular exercise is unpleasant~Measured on a 4 point Likert Scale (range: 1=lower Affective Attitudes to Exercise to 4=higher Affective Attitudes to Exercise)~Higher Affective Attitudes to Exercise - Thinking Behavior is Unpleasant is considered a better outcome~Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items"|90 days|Due to the limitations of data collection and concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related affective attitudes among participants who engaged in the exercise-related mental imagery condition.|||score on a scale||Standard Error|Mean
2534058|NCT03255291|Secondary|Effect of the Intervention on Physical Activity Levels as Measured by Affective Attitudes to Exercise - Enjoying Behavior|"Affective Attitudes to Exercise - Enjoying Behavior is defined as thinking getting regular exercise is enjoyable~Measured on a 4 point Likert Scale (range: 1=lower Affective Attitudes to Exercise to 4=higher Affective Attitudes to Exercise)~Higher Affective Attitudes to Exercise - Enjoying Behavior is considered a better outcome~Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items"|90 days|Due to the limitations of data collection and concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related affective attitudes among participants who engaged in the exercise-related mental imagery condition.|||score on a scale||Standard Error|Mean
2534104|NCT03252964|Secondary|Weekly Average of Estimated Glucose Values (EGV) (Average)|(Sum of EGV for one week)/(Total number of EGV)|up to six months|Lack of study resources to collect sufficient information on this variable.||||||
2534060|NCT03255291|Secondary|Effect of the Intervention on Physical Activity Levels as Measured by Maintenance Self-efficacy|"Maintenance Self-efficacy is defined as being sure one can engage in physical activity even when it is hard~Measured on a 4 point Likert Scale (range: 1=lower Maintenance Self-efficacy to 4=higher Maintenance Self-efficacy)~Higher maintenance self-efficacy is considered a better outcome~Note: to limit participant burden, the investigators used a single item instead of averaging across multiple items"|90 days|Due to the limitations of data collection & concerns about overburdening participants with too many survey questions, the investigators only assessed exercise-related maintenance self-efficacy among participants who engaged in the exercise-related mental imagery condition.|||score on a scale||Standard Error|Mean
2534061|NCT03255291|Primary|Difference in Self-reported Intentions to Engage in Physical Activity by Risk Display Format|"Risk display format = risk ladder, table, or text~Self-reported physical activity intentions is defined as intentions to engage in physical activity in the next 3 months~Measured as an average of three variables, each measured on a 5 point Likert Scale (range: 1=lower intentions to 5=higher intentions)~Higher intentions are considered a better outcome"|Baseline|This study was designed as a 3X2 factorial design & only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome.|||score on a scale||Standard Error|Least Squares Mean
2534062|NCT03255291|Primary|Difference in Verbatim Comprehension of Risk Information by Risk Communication Strategy|"Risk communication strategy = risk ladder, table, or text~Verbatim comprehension of risk information: being able to recall the exact information specific to diabetes risk and hours of recommended weekly physical activity~Measured by the sum of (3) questions coded as correctly comprehending information (1 point) or incorrectly comprehending information (0 points), with a total score range of 0=low comprehension to 3=high comprehension. Higher comprehension is considered a better outcome.~All comprehension questions have an additional don't know option, which is counted as incorrect.~To limit participant burden, the investigators assessed comprehension for diabetes only, instead of all diseases as planned.~Comprehension will not be assessed for people who report a history of diabetes because they are not given risk information."|Baseline|This study was designed as a 3X2 factorial design & only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome.|||score on a scale||Standard Error|Least Squares Mean
2534063|NCT03255291|Primary|Difference in Gist Comprehension of Risk Information by Risk Display Format|"Risk display format = risk ladder, table, or text~Gist comprehension of risk information: being able to extract the bottom-line meaning of information provided by the website (e.g., if exercising decreased heath risk)~Measured by the sum of (4) questions coded as correctly comprehending risk information (1 point) or incorrectly comprehending risk information (0 points), with a total score range of 0=low comprehension to 4=high comprehension. Higher comprehension is considered a better outcome.~All comprehension questions have an additional don't know option, which is counted as incorrect.~To limit participant burden, the investigators assessed comprehension for diabetes only, instead of all diseases as planned.~Comprehension will not be assessed for people who report a history of diabetes because they are not given risk information."|Baseline|This study was designed as a 3X2 factorial design & only the risk display format intervention (risk ladder, table, or text) was looked at for this outcome, as participants had not yet received the mental imagery intervention, thus it could not affect this outcome.|||score on a scale||Standard Error|Least Squares Mean
2534064|NCT03255291|Primary|Change From Baseline to 90-day Follow-up in Self Reported Weekly Minutes of Exercise||Baseline and up to 90 days|Additional participants who did not complete the 90 day follow up survey or completed the survey over 8 weeks late, were inattentive responders, had text messaging errors, or were considered an outlier (>99th percentile) in change in minutes of exercise per week were excluded for analysis|||minutes||Standard Error|Least Squares Mean
2534065|NCT03255187|Secondary|Skin Antioxidant Biomarker-Glutataione (GSH)|we measure another skin antioxidant biomarker-GSH, . The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.|Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months.||||ppb||Standard Deviation|Mean
2534066|NCT03255187|Secondary|Skin Antioxidant Biomarker-Total Antioxidant Capacity (TAC)|we measure TAC level, an antioxidant biomarker in skin samplings. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.|Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months.||||nmol/mL||Standard Deviation|Mean
2534067|NCT03255187|Secondary|Lung Function-Peak Expiratory Flow (PEF)|Additional indicator of lung function includes peak expiratory flow (PEF). The values in the Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.|Lung function is measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.||||L/s||Standard Deviation|Mean
2534068|NCT03255187|Secondary|Lung Function-Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1)|Indicators of lung function include forced vital capacity (FVC) and andforced expiratory volume in 1 second (FEV1). The values in the Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.|Lung function is measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.||||L||Standard Deviation|Mean
2534069|NCT03255187|Secondary|Skin Oxidative Stress Biomarker-Carbonyl Protein|oxidative stress biomarker in skin samplings includes carbonyl protein. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.|Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months.||||µg/ml||Standard Deviation|Mean
2534070|NCT03255187|Secondary|Skin Inflammation Biomarkers|2 infammation biomarkers from skin samplings are measured, including interleukin-1 Alpha (IL-1α) and Interleukin-1 receptor antagonist (IL-1Rα). The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.|Skin samplings are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.||||pg/ml||Standard Deviation|Mean
2534105|NCT03252964|Secondary|Change in A1c Measurement (%)|(Final A1c measure)-(Initial A1c measure)|Day 0 and Day 180|Lack of study resources to collect sufficient information on this variable.||||||
2534072|NCT03255187|Secondary|Blood Pressure|After sitting in a quiet room for at least 5 min, participants had their left upper arm blood pressure measured by trained technicians using an electronic sphygmomanometer at least three times with 3-min minimum intervals between measurements. The second and third sets of readings were averaged to obtain systolic BP (SBP) and diastolic BP (DBP). If the differences among the three measurements were bigger than 5 mmHg, a new round of measurements was arranged. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.|Blood pressure are measured at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.||||mmHg||Standard Deviation|Mean
2534073|NCT03255187|Primary|Serum Level of Lipid Peroxidation (LPO)-a Biomarker of Oxdative Stress|Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of LPO. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.|Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.||||µg/ml||Standard Deviation|Mean
2534074|NCT03255187|Primary|Glutathione Peroxidase (GSH-Px)-a Biomarker of Antioxidant Activity|Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We also measure GSH-Px. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.|Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.||||mU/ml||Standard Deviation|Mean
2534075|NCT03255187|Primary|Oxidized Low Density Lipoprotein (Ox-LDL)-an Oxidative Stress Biomarker|Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of ox-LDL. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.|Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.||||U/L||Standard Deviation|Mean
2534076|NCT03255187|Primary|High-sensitivity C-reactive Protein (Hs-CRP)-an Inflammatory Biomarker|The serum levels of hs-CRP are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.|Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.||||µg/ml||Standard Deviation|Mean
2534077|NCT03255187|Primary|Cogulation Biomarker-Fibrinogen|We measure the serum level of fibrinogen, one of the two measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.|Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.||||µg/ml||Standard Deviation|Mean
2534078|NCT03255187|Primary|Endothelial Function Biomarker-Endothelin-1(ET-1)|We measure ET-1 level in serum, an endothelial function biomarker. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.|Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.||||pg/ml||Standard Deviation|Mean
2534079|NCT03255187|Primary|Biomarkers of Endothelial Function and Stress Hormone|We measure endothelial function biomarkers, including E-selectin and endothelial nitric oxide synthase (eNOS), and 4 stress hormones, including corticotropin releasing hormone (CRH), adrenocorticotropic hormone (ACTH), cortisol and serotonin. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.|Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.||||ng/ml||Standard Deviation|Mean
2534080|NCT03255187|Primary|Cogulation Biomarker-von Willebrand Factor (vWF)|We measure vWF level in serum, one of the measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.|Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.||||mIU/ml||Standard Deviation|Mean
2534081|NCT03255187|Primary|Biomarkers of Inflammation-Interleukin-6 (IL-6) and Tumour Necrosis Factor-α (TNF-α)|2 inflammatory biomarkers in our study including IL-6 and TNF-α are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.|Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.||||pg/ml||Standard Deviation|Mean
2534082|NCT03255187|Primary|Biomarkers of Antioxidant Activity-Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD)|Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure 2 biomarkers of antioxidant activity, including TAC and SOD. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups.|Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.||||U/ml||Standard Deviation|Mean
2534083|NCT03254602|Secondary|Percentage of Change of Pain and Hypoechoic Lesion Volume Compared to Baseline|Compare percentage of Mean changes in pain via the Patient Reported Universal Visual Analog Scale compared to Mean Patient Reported Baseline Pain Scores and percentage of Mean change of Plantar Fascia Hypoechoic Lesion Volume compared to mean baseline Hypoechoic lesion volume following two Intense Therapeutic Ultrasound Treatments, using Diagnostic Ultrasound Images. For Plantar Fascia Hypoechoic Lesion Volume, each lesion volume was calculated using: (4/3) π x R1 x R2 x R3, where r = Radius of each measurement: Lesion Length(1), width(2) and depth(3)|At 12 Weeks after the first treatment|Patients receiving 2 Intense Therapeutic Ultrasound treatments beginning 12 weeks ago|||percentage of Change||Full Range|Mean
2534084|NCT03254602|Secondary|Ultrasound Changes|Diagnostic Ultrasound Changes: Hypoechoic Lesion Volume Reduction following 2 Intense Therapeutic Ultrasound Treatments|At 12 Weeks after the first treatment|Patients receiving 2 Intense Therapeutic Ultrasound Treatments - Average % Volume Reduction of Hypoechoic Plantar Fascia Lesions|||percentage of Lesion Size Reduction||Full Range|Mean
2534106|NCT03252964|Primary|Program Completion Rate (%)|(Number of patients who complete 49 days of CGM use) / (Number of patients who signed the consent form)|up to six months||||Percentage of participants|||Number
2534206|NCT03247673|Primary|AUC0-last|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration|pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI|PK population|||h*ug/mL||Standard Deviation|Mean
2534085|NCT03254602|Primary|Patient Reported Pain Via the Universal Visual Analog Scale: Pass Criteria = at Least 25% Pain Reduction|Patient Reported Pain Reduction meeting or exceeding 25% using the Universal Visual Analog Scale. The Universal Visual Analog Scale is a 10 Point pain scale, where 0 = No Pain, 1 = slight Pain and 10 = the patient's worst imaginable pain. Ratings of 2 to 9 describe pain increases of 10%/Rating. For this measure a reduction of 25% on the Universal Visual Analog Scale is considered meeting the Pain Reduction Criteria. Lower Scale numbers compared to reported baseline ratings equates to pain reduction.|At 12 weeks after the first treatment|Patients receiving 2 Intense Therapeutic Ultrasound Treatments, beginning 12 Weeks ago.|||Percent of Patients meeting criteria|||Number
2534086|NCT03254459|Secondary|Number of Participants With Abnormal Oral Cavity Examinations|Study staff will perform a sublingual (under the tongue) assessment, noting the color of mucosa and whether inflammation is present.|Pre-dose and 90 minutes, 12, 24, 48 and 72 hours after first dose on Days 1 to 4 and End of Study Day 8|Safety population, all participants who received study drug.|||Participants|||Count of Participants
2534087|NCT03254459|Secondary|Number of Participants With Abnormal Electrocardiograms (ECGs) Findings at 90 Minutes,12, 24, 48 and 72 Hours|A standard 12-lead ECG will be performed after the participant is in the supine (lying face up) position for 5 minutes.|Pre-dose and 90 minutes, 12, 24, 48 and 72 hours after first dose|Safety population, all participants who received study drug.|||Participants|||Count of Participants
2534088|NCT03254459|Secondary|Pulse Oximetry Levels at 90 Minutes,12, 24, 48 and 72 Hours|Pulse oximetry is a non-invasive method to measure a person's oxygen saturation.|90 Minutes,12, 24, 48 and 72 Hours|Safety population, all participants who received study drug.|||percentage of oxygen saturation||Standard Deviation|Mean
2534089|NCT03254459|Secondary|Total Use of Rescue Medication for Nausea Over 0 to 24 Hours, Over 0 to 48 Hours, Over 0-72 Hours and 0-7 Days|Zofran was used at the clinician's discretion as rescue medication for nausea. The total use of rescue medication was calculated for the following 4 time-frames: 0 to 24 hours, 0 to 48 hours, 0 to 72 hours and 0 to 7 days.|0 to 24 hours, 0 to 48 hours, 0 to 72 hours and 0 to 7 days|Safety population, all participants who received study drug.|||cumulative number of rescue doses|||Number
2534090|NCT03254459|Secondary|Time to First Use of Rescue Medication for Nausea Following Each Dose of the Investigational Product (IP)|"Zofran was used at the clinician's discretion as rescue medication for nausea. Time 0 is defined as the time of the administration of study drug."|Days 1 to 7|Safety population, all participants who received study drug.|||hours||95% Confidence Interval|Median
2534091|NCT03254459|Secondary|Percentage of Participants Provided Rescue Medication for Nausea|Zofran was used at the clinician's discretion as rescue medication for nausea.|Days 1 to7|Safety population, all participants who received study drug.|||percentage of participants|||Number
2534092|NCT03254459|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A TEAE is an AE with onset that occurs after receiving study drug.|Days 1 to 8|Safety population, all participants who received study drug.|||Participants|||Count of Participants
2534093|NCT03254147|Secondary|The Number of Patients With Cardiac Tamponade and Pericardiocentesis.|The number of patients with cardiac tamponade and pericardiocentesis. Cardiac tamponade diagnosis (ICD 10 code 4200001) on the same or next day as catheter ablation or percutaneous coronary intervention (PCI), Pericardiocentesis (Medical Data Vision (MDV) procedure code 140010510) on the same or next day as catheter ablation or PCI.|One year|Results are based on the number of patients meeting the inclusion and exclusion criteria.|||Number of Patients|||Number
2534094|NCT03254147|Primary|The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.|The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma.|One year|Results are based on the number of patients meeting the inclusion and exclusion criteria.|||Number of Patients|||Number
2534095|NCT03254134|Secondary|Incidence Rate of Major Bleeding|Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims.|From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of major bleeding, ie., up to 6.5 years.|Eligible patient who were prescribed dabigatran and warfarin as the first OACs and matched 1: 1 using the propensity score matching (PSM).|||per patient-year|||Number
2534096|NCT03254134|Primary|Incidence Rate of Stroke and Systemic Embolism (SE)|Incidence rate of stroke and systemic embolism (SE).|From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of stroke and systemic embolism, ie., up to 6.5 years.|Eligible patient who were prescribed dabigatran and warfarin as the first OACs and matched 1: 1 using the propensity score matching (PSM).|||per patient-year|||Number
2534097|NCT03252964|Secondary|Coaching Participation Rate|(Sum of weekly coaching calls completed)/(Total number of weeks)|up to six months|Lack of study resources to collect sufficient data on outcome variable.||||||
2534098|NCT03252964|Secondary|Texting With Coaches (Daily Average of Text Messages)|(Sum of all text messages)/(Total number of days)|up to six months|Lack of study resources to collect sufficient data on outcome variable.||||||
2534099|NCT03252964|Secondary|Ethnicity of Participants Who Start the Trial (n)|Sum of Hispanic or Latino and Sum of Not Hispanic or Latino|up to three months|Lack of study resources to collect sufficient data on outcome variable.||||||
2534100|NCT03252964|Secondary|Race of Participants Who Start the Trial (n)|Sum of American Indian or Alaska Native, Sum of Asian, Sum of Black or African American, Sum of Native Hawaiian or Other Pacific Islander, Sum of White|up to three months|Lack of study resources to collect sufficient data on outcome variable.||||||
2534107|NCT03252964|Primary|Program Enrollment Rate (%)|(Number of patients who signed a consent form)/(Number of patients invited to enroll)|up to three months|52 participants enrolled in the study. Hence, 52 participants analyzed. However, enrollment rate is the number of participants enrolled (52) divided by the number of candidates contacted (364). This explains why the Overall Number of Participants Analyzed is greater than the number Started in the Participant Flow.|||Percentage of participants|||Number
2534108|NCT03252015|Secondary|Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam on Day 7|PK of midazolam.|Day 7:Predose, 0,5hr,1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose|All randomized participant who received midazolam on Day 7 and had evaluable PK parameters.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534109|NCT03252015|Secondary|Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Midazolam|PK: Cmax of midazolam.|Day -3: Predose, 0.5 hour(hr), 1hr, 1.5hr. 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, and 12 hr postdose,|All randomized participant who received midazolam on Day -3 and had evaluable PK parameters.|||nanograms per milliLiter||Geometric Coefficient of Variation|Geometric Mean
2534110|NCT03252015|Secondary|Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 7|Cmax of M8 on Day 7 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.|Day 7: Predose, 0.5hr, 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr and 48 hr postdose|All participants who received at least one dose of lasmiditan and had evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2534111|NCT03252015|Secondary|Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Metabolite M8 on Day 1|Cmax of M8 on Day 1 following a single and repeated oral daily dosing of 200 and 400 mg lasmiditan. M8 is a metabolite of lasmiditan.|Day 1: 0.5 hr, 1hr, 1.5hr, 2 hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24 hr adn 48 hr postdose|All participant who received at least 1 dose of lasmiditan and had evaluable PK data.|||mg/mL||Geometric Coefficient of Variation|Geometric Mean
2534112|NCT03252015|Secondary|Physician Withdrawal Checklist (PWC)Total Score|Physician Withdrawal Checklist (PWC) : 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected.|Day 7 and Day 21 at anytime|All participants who received at least 1 dose of study drug and had completed the questionnaire.|||units on a scale||Standard Deviation|Mean
2534113|NCT03252015|Secondary|Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score|BWSQ is a 20 item, self administered withdrawal symptom questionnaire. Each question is scored by a 0 representing no withdrawal symptoms, 1 for moderate symptoms, 2 for severe symptoms. Total score at each time point will be averaged for each treatment in each cohort.|PreDose Day 7 and Day 21|All participants who received at least 1 dose of study drug and completed the questionnaire.|||units on a scale||Standard Deviation|Mean
2534114|NCT03252015|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 7|PK AUCtau of lasmiditan|Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr,and 24hr postdose|All participants who received at least 1 dose of lasmiditan on Day 1 and had evaluable PK data.|||nanograms time hours per milliLiter||Geometric Coefficient of Variation|Geometric Mean
2534115|NCT03252015|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve to the End of the Dosing Period (AUC[Tau]) Lasmiditan on Day 1|PK: AUCtau of lasmiditan|Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, and 24hr postdose|All participants who received at least 1 dose of lasmiditan on Day 1 and had evaluable PK data.|||nanograms times hour per milliLiter||Geometric Coefficient of Variation|Geometric Mean
2534116|NCT03252015|Secondary|Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 7|PK: Cmax of lasmiditan Day 7|Lasmiditan PK: Day 7: 0.5hour(hr), 1hr, 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr postdose|All participants who received at least 1 dose of lasmiditan on Day 7 and had evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2534117|NCT03252015|Secondary|Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan on Day 1|PK: Cmax of lasmiditan|Lasmiditan PK: Day 1:0.5 hour (hr), 1hr , 1.5hr, 2hr, 2.5hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr and 48 hr postdose|All participants who received at least 1 dose of lasmiditan on Day 1 and had evaluable PK data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2534118|NCT03252015|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. Adverse events for this outcome measure are reported by arm. SAEs are reported by study drug in the Adverse Events module.|Baseline through 14 days after last administration of study drug|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2534119|NCT03251937|Primary|Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline||3 months post activation||||Participants|||Count of Participants
2534120|NCT03251482|Secondary|Number of Participants With Distal DVT (CEC-adjudicated)|Number of participants with distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.|Up to Day 10 to 14 (visit observation period)|mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.|||Participants|||Count of Participants
2534121|NCT03251482|Secondary|Number of Participants With Proximal and Distal DVT (CEC-adjudicated)|Number of participants with proximal and distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.|Up to Day 10 to 14 (visit observation period)|mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.|||Participants|||Count of Participants
2534122|NCT03251482|Secondary|Number of Participants With Death (CEC-adjudicated)|Number of participants with death (adjudicated by CEC) were reported.|Up to Day 10 to 14 (visit observation period)|mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.|||Participants|||Count of Participants
2534123|NCT03251482|Secondary|Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated)|Number of participants with nonfatal PE (adjudicated by CEC) were reported.|Up to Day 10 to 14 (visit observation period)|mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.|||Participants|||Count of Participants
2534124|NCT03251482|Secondary|Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated)|Number of participants with proximal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.|Up to Day 10 to 14 (visit observation period)|mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.|||Participants|||Count of Participants
2534125|NCT03251482|Secondary|Number of Participants With Major VTE (CEC-adjudicated)|Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.|Up to Day 10 to 14 (visit observation period)|mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event or any death.|||Participants|||Count of Participants
2534126|NCT03251482|Secondary|Number of Participants With Minimal Bleeding Events (CEC-adjudicated)|Number of participants with minimal bleeding events (adjudicated by CEC) were reported. Minimal bleeding event was defined as any bleeding event not met major or CRNM criteria.|Up to Day 10 to 14 (visit observation period)|Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug.|||Participants|||Count of Participants
2534127|NCT03251482|Secondary|Number of Participants With Major Bleeding or CRNM Bleeding Events (CEC-adjudicated)|Number of participants with major bleeding or CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.|Up to Day 10 and 14 (visit observation period)|Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug.|||Participants|||Count of Participants
2534128|NCT03251482|Secondary|Number of Participants With Clinically Relevant Non-major (CRNM) Bleeding Events (CEC-adjudicated)|Number of participants with CRNM bleeding events (adjudicated by CEC) were reported. CRNM bleeding was defined as acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major bleeding event and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.|Up to Day 10 to 14 (visit observation period)|Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug.|||Participants|||Count of Participants
2534129|NCT03251482|Secondary|Number of Participants With Major Bleeding Event (CEC-adjudicated)|Number of participants with major bleeding events (BE) (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in hemoglobin (Hb) level of 20 grams per liter (g/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability.|Up to Day 10 to 14 (visit observation period)|Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug.|||Participants|||Count of Participants
2534130|NCT03251482|Secondary|Number of Participants With Composite of Major and CRNM Bleeding Events (CEC-adjudicated)|Number of participants with composite of major and CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.|Up to Day 10 to 14 (visit observation period)|Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug.|||Participants|||Count of Participants
2534131|NCT03251482|Primary|Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated)|Number of participants with total VTE were reported. Total VTE was defined as the composite of CEC-adjudicated proximal and/or distal deep vein thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death assessed through the Day 10 to 14 visit. 1 participant had an asymptomatic distal clot in the non-operated leg which is not counted in the Total VTE and 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.|Up to Day 10 to 14 (visit observation period)|Modified Intent-to-treat (mITT) analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death adjudicated by CEC.|||Participants|||Count of Participants
2534132|NCT03251482|Primary|Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated)|Number of participants with treatment-emergent bleeding events (BE) (adjudicated by CEC) were reported. Bleeding event was defined as the composite of major, clinically relevant nonmajor (CRNM), and minimal bleeding events assessed through the Day 10 to 14.|Up to Day 10 to 14 (visit observation period)|Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).|||Participants|||Count of Participants
2534133|NCT03250845|Secondary|Patient Satisfaction Questionnaire.|"Assess patient satisfaction via questionnaires. Questionnaires were taken at the end of MG 10% infusion and were validated by the principal investigator (PI) and head nurse.~Patients could score following questions from 1 (strongly disagree) to 5 (strongly agree) [Full scale: 1: strongly disagree; 2:disagree; 3: neutral; 4: agree; 5; strongly agree]:~Question 1: I experienced less side effects during Multigam 10% infusion. Question 2: I experienced time gain with Multigam 10%. Question 3: I had a more productive day with Multigam 10%. Question 4: I am in favor of of the use of Multigam 10%."|End of study (after Multigam 10% infusion)|Row 3: 1 patient was unable to assess the question|||score on a scale||Full Range|Median
2534134|NCT03250845|Secondary|Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration|Evaluate the number of actions taken by the nursing staff during Multigam administration. Nursing actions were defined as the sum of actions required to increase the infusion rate (if needed) and any other action that had to be taken due to adverse effects during administration (e.g. lowering of infusion rate or supportive medication). Standard procedures like taking parameters were not accounted for this evaluation.|During each infusion (up to 1 day)||||Nursing actions per patient||95% Confidence Interval|Mean
2534135|NCT03250845|Secondary|IVIg-related Adverse Events Per Patient During Multigam IV 5% and Multigam IV 10% Administration|"Evaluation of the occurence of adverse events (AEs) for both administrations via CTCAE v4.03 criteria.~Results are reported as the mean number of IVIg-related AEs per patient. Adverse events were actively monitored during infusion and patients could report adverse events up to 72h after infusion."|Up to 72 after each infusion||||IVIg-related AEs per patient||95% Confidence Interval|Mean
2534136|NCT03250845|Secondary|Hospitalisation Time of Multigam IV 5% and Multigam IV 10%|Comparison of hospitalisation time (time spent at day clinic) between Multigam IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval.|Up to 1 month after Multigam 5% infusion||||hour||95% Confidence Interval|Mean
2534137|NCT03250845|Primary|Infusion Time of Multigam IV 5% and Multigam IV 10%|Comparison of infusion time between Multigam (MG) IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval.|Up to 1 month after Multigam 5% infusion||||hour||95% Confidence Interval|Mean
2534138|NCT03250689|Secondary|Time of Last Observed Concentration (Tlast) of Danirixin|Blood samples were collected to evaluate the PK of danirixin at the indicated time points for the analysis of Tlast.|Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours||Full Range|Median
2534139|NCT03250689|Secondary|Area Under the Blood Concentration-time Curve [AUC(0-t)] of Danirixin|Blood samples were collected to evaluate the PK of danirixin at the indicated time points for the analysis of AUC(0-t).|Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed.|||Hours * nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534140|NCT03250689|Secondary|Time to Cmax (Tmax) of Danirixin|Blood samples were collected to evaluate the PK of danirixin at the indicated time points for the analysis of Tmax.|Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours||Full Range|Median
2534141|NCT03250689|Secondary|Maximum Observed Concentration (Cmax) of Danirixin|Blood samples were collected to evaluate the pharmacokinetic (PK) of danirixin at the indicated time points for the analysis of Cmax. PK population consisted of all participants in the Modified Intent-To-Treat population who had at least 1 non-missing PK assessment (non-quantifiable values were considered as non-missing values).|Days 1 and 14: Pre-dose and 0.5, 1, 2 and 4 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534142|NCT03250689|Secondary|Percentage Change From Baseline in Peripheral Blood Neutrophil NETs Formation Quantified by Microscopy|Blood samples were collected at indicated time points to analyze peripheral blood neutrophil NETs formation by microscopy.DNA-elastase complexes quantified NETs formation.PMA was used to induce inflammation and NETs formation in PMA stimulated samples. Blood from participants were tested at Baseline and Day14 for non-PMA stimulated samples,and at Baseline and Day14 in PMA-stimulated samples to test whether treatment had any effect on NETs formation either naturally(non PMA induced)or where NETs formation was already raised(PMA stimulated).Participants were counted in both categories-PMA stimulated and not PMA stimulated.NETs formation in peripheral blood was measured with SYTOX green fluorescence quantification of extracellular DNA.Baseline was considered as Day1.Change from Baseline was calculated as post-Baseline value minus Baseline value.Percentage change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplied by100.|Baseline (Day 1) and Day 14|Modified Intent-to-Treat Population. Only those participants with data available at the specified data points were analyzed.|||Percent change||Standard Error|Mean
2534157|NCT03250689|Secondary|Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Counts, Total Neutrophils, White Blood Cell (WBC) Count|Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets counts, Total neutrophils and WBC count. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1) and Day 14|Modified Intent-to-Treat Population.|||Giga cells per liter||Standard Deviation|Mean
2534158|NCT03250689|Secondary|Spirometry: Forced Vital Capacity (FVC) at Indicated Time Points|FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It was measured by spirometry test. Mean and standard deviation data of FVC measured at Day 1 and Day 14 have been presented.|Day 1 and Day 14|Modified Intent-to-Treat Population.|||Liter||Standard Deviation|Mean
2534143|NCT03250689|Secondary|Change From Baseline in Peripheral Blood Neutrophil NETs Formation Quantified by DNA Release|Blood samples were collected at indicated time points to analyze peripheral blood neutrophil NETs formation by DNA release. DNA-elastase complexes quantified NETs formation. Phorbol 12-myristate 13-acetate (PMA) was used to induce inflammation and NETs formation in the PMA stimulated samples. Blood from participants were tested at Baseline and Day 14 for non-PMA stimulated samples, and at Baseline and Day 14 in PMA-stimulated samples to test whether treatment had any effect on NETs formation either naturally (non PMA induced) or where NETs formation was already raised (PMA stimulated). Hence participants were counted in both the categories - PMA stimulated and not PMA stimulated. NETs formation in peripheral blood was measured with SYTOX green fluorescence quantification of extracellular DNA. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1) and Day 14|Modified Intent-to-Treat Population. Only those participants with data available at the specified data points were analyzed.|||Relative fluorescence units||Standard Error|Mean
2534144|NCT03250689|Secondary|Change From Baseline in Sputum Elastase Activity|Sputum samples were collected at indicated time points to analyze sputum elastase activity. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1), Day 7 and Day 14|Primary Completer Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Nanograms per milliliter||Standard Error|Mean
2534145|NCT03250689|Secondary|Change From Baseline in the Ratio of Sputum NETs to Sputum Neutrophils|Sputum samples were collected to calculate ratio of sputum NETs to sputum neutrophils. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value. The ratio is calculated as the sputum NETs divided by the number of sputum neutrophils.|Baseline (Day 1) and Day 14|Primary Completer Population. Only those participants with data available at the specified data points were analyzed.|||Ratio||Standard Error|Mean
2534146|NCT03250689|Secondary|Change From Baseline in Sputum Resistin Levels|Sputum samples were collected at indicated time points to analyze resistin levels. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1), Day 7 and Day 14|Primary Completer Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Nanograms per milliliter||Standard Error|Mean
2534147|NCT03250689|Secondary|Change From Baseline in Urinalysis Parameter: Potential of Hydrogen (pH)|Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1) and Day 14|Modified Intent-to-Treat Population.|||pH||Standard Deviation|Mean
2534148|NCT03250689|Secondary|Change From Baseline in Urinalysis Parameter: Specific Gravity|Urinary specific gravity measurement is a part of routine urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1) and Day 14|Modified Intent-to-Treat Population.|||Unitless||Standard Deviation|Mean
2534149|NCT03250689|Secondary|Change From Baseline in Chemistry Parameters: Creatinine, Direct Bilirubin, Total Bilirubin|Blood samples were collected to analyze the chemistry parameters: Creatinine, Direct Bilirubin and Total Bilirubin. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1) and Day 14|Modified Intent-to-Treat Population.|||Micromoles per liter||Standard Deviation|Mean
2534150|NCT03250689|Secondary|Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium, Urea|Blood samples were collected to analyze the chemistry parameters: Calcium, Glucose, Potassium, Sodium and Urea. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1) and Day 14|Modified Intent-to-Treat Population.|||Millimoles per liter||Standard Deviation|Mean
2534151|NCT03250689|Secondary|Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST)|Blood samples were collected to analyze the chemistry parameters: ALT, ALP and AST. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1) and Day 14|Modified Intent-to-Treat Population.|||International units per liter||Standard Deviation|Mean
2534152|NCT03250689|Secondary|Change From Baseline in Hematology Parameter: Red Blood Cell Count|Blood samples were collected to analyze the hematology parameter: Red Blood Cell count. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1) and Day 14|Modified Intent-to-Treat Population.|||Trillion cells per liter||Standard Deviation|Mean
2534153|NCT03250689|Secondary|Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin|Blood samples were collected to analyze the hematology parameter: Mean Corpuscular Hemoglobin. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1) and Day 14|Modified Intent-to-Treat Population.|||Picograms||Standard Deviation|Mean
2534154|NCT03250689|Secondary|Change From Baseline in Hematology Parameter: Mean Corpuscular Volume|Blood samples were collected to analyze the hematology parameter: Mean Corpuscular Volume. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1) and Day 14|Modified Intent-to-Treat Population.|||Femtoliter||Standard Deviation|Mean
2534155|NCT03250689|Secondary|Change From Baseline in Hematology Parameter: Hemoglobin|Blood samples were collected to analyze the hematology parameter: Hemoglobin. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1) and Day 14|Modified Intent-to-Treat Population.|||Grams per liter||Standard Deviation|Mean
2534156|NCT03250689|Secondary|Change From Baseline in Hematology Parameter: Hematocrit|Blood samples were collected to analyze the hematology parameter: Hematocrit. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1) and Day 14|Modified Intent-to-Treat Population.|||Percentage of red blood cells in blood||Standard Deviation|Mean
2534159|NCT03250689|Secondary|Spirometry: Forced Expiratory Volume in One Second (FEV1) at Indicated Time Points|FEV1 is the amount of air that can be forcefully exhaled from the lungs in the first second of a forced exhalation. It was measured by spirometry test. Mean and standard deviation data of FEV1 measured at Day 1 and Day 14 have been presented.|Day 1 and Day 14|Modified Intent-to-Treat Population.|||Liter||Standard Deviation|Mean
2534160|NCT03250689|Secondary|Change From Baseline in PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)|Triplicate 12-lead electrocardiograms (ECG) were obtained to measure PR Interval, QRS Duration, QT Interval and QTcF Interval. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1) and Day 14|Modified Intent-to-Treat Population.|||Milliseconds||Standard Deviation|Mean
2534161|NCT03250689|Secondary|Change From Baseline in Respiration Rate|Respiration rate was measured in seated position after 5 minutes rest for the participants at indicated time points. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1), Day 7 and Day 14|Modified Intent-to-Treat Population.|||Breaths per minute||Standard Deviation|Mean
2534162|NCT03250689|Secondary|Change From Baseline in Heart Rate|Heart rate was measured in seated position after 5 minutes rest for the participants at indicated time points. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1), Day 7 and Day 14|Modified Intent-to-Treat Population.|||Beats per minute||Standard Deviation|Mean
2534163|NCT03250689|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured in seated position after 5 minutes rest for the participants at indicated time points. Baseline was considered as Day 1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1), Day 7 and Day 14|Modified Intent-to-Treat Population.|||Millimeters of mercury||Standard Deviation|Mean
2534164|NCT03250689|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes, Modified Intent-to-Treat Population consisted of all randomized participants who received at least one dose of study treatment.|Up to Day 21|Modified Intent-to-Treat Population.|||Participants|||Count of Participants
2534165|NCT03250689|Secondary|Change From Baseline in Percentage of Microscope Field Area Occupied by Sputum NETs|Sputum samples were collected at indicated time points and NETs area was quantified by microscopy. Baseline was considered as Day 1. If Day 1 values were missing, screening value was imputed for Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1), Day 7 and Day 14|Primary Completer Population. Only those participants with data available at the specified data points were analyzed.|||Percentage of microscope field area||Standard Error|Mean
2534166|NCT03250689|Secondary|Change From Baseline in Sputum NETs Quantified by Deoxyribonucleic Acid (DNA)-Elastase Complexes|Sputum samples were collected at indicated time points to assess NET formation via DNA elastase complexes. Baseline was considered as Day 1. If Day 1 values were missing, screening value was imputed for Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 1), Day 7 and Day 14|Primary Completer Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Units per milliliter||Standard Error|Mean
2534167|NCT03250689|Primary|Percentage Change From Baseline in Sputum Neutrophil Extracellular Traps (NETs) Quantified by Histone-Elastase Complexes|Sputum samples were collected at indicated time points to assess NET formation via histone elastase complexes. Baseline was considered as Day 1. If Day 1 values were missing, screening value was imputed for Baseline. Change from Baseline was calculated as post-Baseline value minus Baseline value. Percentage change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplied by 100. Analysis was performed using a mixed effect repeated measures model with covariates of treatment group, log(Baseline NETs) and treatment group by day interaction. The response variable was the log of the ratio of post-Baseline NETs to Baseline NETs. Primary completer population consisted of all participants in the Modified Intent-To-Treat population who had completed the assessments supporting the primary endpoint (sputum NETs).|Baseline (Day 1), Day 7 and Day 14|Primary Completer Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent change||95% Confidence Interval|Mean
2534168|NCT03249935|Secondary|Evaluate the Association of Laboratory Findings and Other Participant Characteristics to Chlamydia Treatment Failure in Males After Azithromycin Treatment|Odds ratios for the outcome of treatment failure calculated for laboratory findings (enrollment chlamydia load and OmpA genotype) and other participant characteristics (demographics, sexual behaviors, etc.). Note that samples were not run for OmpA genotype.|Day 28-follow-up visit|Per protocol population, which included all participants who tested positive for CT at enrollment and were evaluable for treatment failure at day 28.|||Participants|||Count of Participants
2534169|NCT03249935|Primary|Proportion of Participants Experiencing Treatment Failure After Treatment With Azithromycin for Uncomplicated Chlamydia Trachomatis (CT) in Males With and Without Urethral Symptoms|Test positive for Chlamydia trachomatis with Aptima Combo 2® Assay (AC2) and having enrollment and follow-up CT strains that had concordant genotyping of the CT major outer membrane protein (ompA) sequences or, if genotyping was unsuccessful on urine from both visits (i.e., due to insufficient number of ompA copies), then participants could not have unsupervised furloughs or report interim sex to be categorized as a treatment failure.|Day 28-follow-up visit|Per protocol population, which included all participants who tested positive for CT at enrollment and were evaluable at day 28.|||Participants|||Count of Participants
2534207|NCT03247673|Primary|Cmax|Maximum Serum Concentration (Cmax)|pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI|PK population|||ug/mL||Standard Deviation|Mean
2534170|NCT03249779|Primary|Change in International Restless Legs Syndrome Rating Scale (IRLS)|"The International Restless Legs Syndrome Rating Scale (IRLS) questionnaire will be used for this purpose.~The IRLS is a validated patient-reported outcome measure to accurately assess disease severity of restless legs syndrome. It has questions on the primary features of restless legs syndrome, along with intensity and frequency, associated sleep problems. For this study subjects were asked to answer 10 questions on how often they experienced each symptom, using a score of 0-4, 0 being None and 4 being Very severe. Answers from these questions were combined to provide a total Restless Legs Syndrome score (for a total possible range of 0-40) for each patient at each visit. Lower scores reflected fewer symptoms and higher scores reflected more symptoms."|baseline, 1 week post treatment (approximately 3 weeks)||||score on a scale||Standard Deviation|Mean
2534171|NCT03249779|Primary|Change in International Restless Legs Syndrome Rating Scale (IRLS)|"The International Restless Legs Syndrome Rating Scale (IRLS) questionnaire will be used for this purpose.~The IRLS is a validated patient-reported outcome measure to accurately assess disease severity of restless legs syndrome. It has questions on the primary features of restless legs syndrome, along with intensity and frequency, associated sleep problems. For this study subjects were asked to answer 10 questions on how often they experienced each symptom, using a score of 0-4, 0 being None and 4 being Very severe. Answers from these questions were combined to provide a total Restless Legs Syndrome score (for a total possible range of 0-40) for each patient at each visit. Lower scores reflected fewer symptoms and higher scores reflected more symptoms."|baseline, 2 weeks||||score on a scale||Standard Deviation|Mean
2534172|NCT03249454|Secondary|Change in Heart Rate|Heart rate will be recorded before and after delivering each intervention|60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)|Those who completed the study were analyzed. Data are reported per session. After randomization, there were potentially 22 cathode sessions, 22 anode sessions, and 11 sham sessions--of these sessions, data were not collected for 2 cathode sessions, 3 anode sessions, and 2 sham sessions.|||beats per minute (bpm)|sessions|Standard Deviation|Mean
2534173|NCT03249454|Secondary|Change in Diastolic Blood Pressure|Diastolic Blood pressure will be recorded before and after delivering each intervention|60 to 90 minutes before intervention,60 to 90 minutes after intervention ( for each intervention)|Those who completed the study were analyzed. Data are reported per session. After randomization, there were potentially 22 cathode sessions, 22 anode sessions, and 11 sham sessions--of these sessions, data were not collected for 2 cathode sessions, 3 anode sessions, and 2 sham sessions.|||millimeters of mercury (mmHg)|sessions|Standard Deviation|Mean
2534174|NCT03249454|Secondary|Change Systolic Blood Pressure|Systolic Blood pressure will be recorded before and after each tsDCS session.|60 to 90 minutes before intervention, 60 to 90 minutes after intervention|Those who completed the study were analyzed. Data are reported per session. After randomization, there were potentially 22 cathode sessions, 22 anode sessions, and 11 sham sessions--of these sessions, data were not collected for 2 cathode sessions, 3 anode sessions, and 2 sham sessions.|||millimeters of mercury (mmHg)|sessions|Standard Deviation|Mean
2534175|NCT03249454|Primary|Change in Somatosensory Evoked Potential (SSEP)|A somatosensory evoked potential (SSEP) is the electrical activity response measured at the skin's surface along ascending sensory pathway following controlled peripheral nerve stimulation by tsDCS. For recording posterior tibial nerve SSEPs, the nerve is stimulated at the ankle, with the cathode midway between the Achilles tendon and the medial malleolus and the anode 3 cm distal to the cathode. Nerve stimulation should consist of a 0.1-0.2 ms duration square wave pulse at 3-5 Hertz (Hz). These pulses will be delivered by constant voltage stimulator applied transcutaneously over the targeted nerve. The stimulation intensity would exceed the motor threshold for eliciting a muscle twitch. Electromyogram (EMG)/ Nerve Conduction Velocity (NCV) measuring system will be used to measure SSEPs.|30 to 40 minutes before intervention, 30 to 40 minutes after intervention|Data was not collected for this outcome measure.||||||
2534176|NCT03249454|Primary|Percent Change in Hmax|Immediately before application of tsDCS and after application of tsDCS, Hmax will be obtained from soleus muscle by stimulation of tibial nerve. The H-reflex is a compound muscle action potential elicited by low-threshold electrical stimulation of afferent fibers in the mixed nerve with subsequent monosynaptic excitation of alpha motoneurons. Changes in the excitability of the reflex pathway are estimated by measuring the amplitude of the reflex.|10 minutes before intervention, 10 minutes after intervention|Those who completed the study were analyzed. Data are reported per session. There were potentially 22 cathode, 22 anode, and 11 sham sessions. Data for the Right Lower Extremity were not collected for 3 cathode, 3 anode, and 2 sham sessions, and data for the Left Lower Extremity were not collected for 3 cathode, 1 anode, and 2 sham sessions.|||percent change in Hmax|sessions|Standard Deviation|Mean
2534177|NCT03248882|Secondary|Number of Participants With 12-Lead Electrocardiogram (ECG) Data Meeting Predefined Criteria|ECG categorical summarization criteria: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization) >=140 milliseconds (msec); 2) QRS interval >=50% change from baseline; 3) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization) >=300 msec; 4) PR interval >=25% change when baseline is >200 msec or >=50% change when baseline is <=200 msec; 5) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of >=500 msec; 6) QTcF interval (QT corrected for heart rate using Fridericia's formula) absolute value of 450 to <480 msec; 7) QTcF interval: absolute value of 480 to <500 msec; 8) QTcF interval: absolute value >=500 msec; 9) QTcF interval: a change from baseline of 30 to <60 msec; 10) QTcF interval: a change from baseline >=60 msec.|From first dose of study treatment (Day 1) up to Week 18|All randomized participants who received at least 1 dose of randomized study treatment and had ECG data.|||Participants|||Count of Participants
2534178|NCT03248882|Secondary|Number of Participants With Vital Signs Data Meeting Predefined Criteria|Vital signs categorical summarization criteria: 1) sitting systolic blood pressure (SBP) <90 or >180 millimeters of mercury (mmHg); 2) sitting diastolic blood pressure (DBP) <50 mmHg or >110 mmHg; 3) sitting pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in sitting DBP greater than or equal to (>=) 20 mmHg; 5) change from baseline (increase or decrease) in sitting SBP >=30 mmHg.|From first dose of study treatment (Day 1) up to Week 18|All randomized participants who received at least 1 dose of randomized study treatment and had vital signs data.|||Participants|||Count of Participants
2534179|NCT03248882|Secondary|Number of Participants With Laboratory Abnormalities|Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time [PT], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin, granular casts).|From first dose of study treatment (Day 1) up to Week 20|All randomized participants who received at least 1 dose of randomized study treatment and had laboratory data.|||Participants|||Count of Participants
2534180|NCT03248882|Secondary|Number of Participants With Treatment-Emergent Adverse Events|An AE was any untoward medical occurrence in a study subject administered a product or medical device. A serious AE (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.|From first dose of study treatment (Day 1) up to Week 20|All randomized participants who received at least 1 dose of randomized study treatment.|||Participants|||Count of Participants
2534181|NCT03248882|Secondary|Percent Change From Baseline in Alanine Aminotransferase at Week 16|Potential improvement in liver function was denoted by reduction in alanine transaminase (ALT)|Baseline (Day 1 pre-dose), Week 16|All randomized participants who received at least 1 dose of randomized study treatment and diagnosed/presumed with nonalcoholic steatohepatitis.|||Percent change||80% Confidence Interval|Least Squares Mean
2534182|NCT03248882|Primary|Percent Change From Baseline in Liver Fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI- PDFF) at Week 16|MRI-PDFF utilized a gradient echo sequence with low flip angle (FA) to minimize T1 bias, corrected T2* decay (due to iron overload) via modeling of the fat signal as a superposition of multiple frequency components from 5 different lipid types, and was applied in each of the 9 Couinaud segments. This technique improved fat quantification accuracy for the entire liver permitting quantification of small differences/changes following pharmacological intervention.|Baseline (between Day -14 and Day 1), Week 16|All randomized participants who received at least 1 dose of randomized study treatment and with non-missing baseline and post-baseline endpoint.|||Percent change||80% Confidence Interval|Least Squares Mean
2534183|NCT03248492|Secondary|Overall Summary of Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Safety Analysis Set)|TEAEs were assessed by severity and seriousness according to unique criteria. Severity described the intensity of an event and was graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Life-threatening consequences; urgent intervention indicated; and Grade 5: Death related to AE. Serious TEAEs were defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires inpatient hospitalization, or causes prolongation of existing hospitalization.|Day 0 to Day 47 post last dose|Adverse event data were assessed in the Safety Analysis Set t data cut-off date of 21 March 2019.|||Participants|||Count of Participants
2534184|NCT03248492|Secondary|Percent Change From Baseline in Sum of Diameters Over Time as Determined by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)|Best percent change in sum of diameters of measurable tumors was based on RECIST 1.1. The best percent change was defined as the percent change in the smallest sum of diameters from all post-baseline tumor assessments, taking as reference the baseline sum of diameters.|Baseline up to Week 6, 12, 18, 24, 30, 36 post dose|Best percent change from baseline in sum of diameters was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.|||Percent change from baseline||Standard Deviation|Mean
2534185|NCT03248492|Secondary|Progression-Free Survival Estimate As Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)|The point estimate of progression-free survival (PFS) is reported. PFS was defined as the time interval between the date of randomization/registration and the first documentation of disease progression or death due to any cause.|at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)|Progression-free survival was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.|||months||95% Confidence Interval|Median
2534186|NCT03248492|Secondary|Duration of Response (Complete Response or Partial Response) as Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)|The estimated duration of confirmed response (complete response [CR] or partial response [PR]) was assessed by independent central review. Duration of response was defined as the time interval between the date of first documentation of objective response (CR or PR) and the date of the first objective documentation of disease progression or death due to any cause.|at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)|Participants with CR or PR were analyzed. Estimated duration of response was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.|||months||95% Confidence Interval|Median
2534203|NCT03247738|Primary|Platelet Reactivity Measured by VerifyNow PRU|Platelet reactivity at 30 minutes after starting cangrelor or placebo assessed by VerifyNow PRU and reported as P2Y12 Reaction Units (PRU)|30 minutes|The analyzed patients included all patients with pharmacodynamic data and without a major protocol deviation thought to affect the pharmacodynamic effects of ticagrelor or cangrelor.|||P2Y12 reaction units (PRU)||95% Confidence Interval|Least Squares Mean
2534204|NCT03247673|Secondary|Number of Participants With Anti-Drug Antibody Positive|number of participants with anti-drug antibody positive at post-dose|up to 15 weeks|Safety Population|||Participants|||Count of Participants
2534187|NCT03248492|Secondary|Disease Control Rate and Clinical Benefit Rate as Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)|Number of participants with controlled disease and who received clinical benefit from treatment as assessed by independent central review. DCR was defined as the proportion of participants who achieved a best overall response of complete response, partial response, or stable disease. CBR was defined as the proportion of participants who achieved a best overall response of complete response or partial response or more than 6 months of stable disease.|at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)|Disease control rate (DCR) and clinical benefit rate (CBR) were assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.|||Participants|||Count of Participants
2534188|NCT03248492|Secondary|Best Overall Tumor Response as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)|Best overall tumor response was defined as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) by the investigator based on RECIST v1.1. Participants who were non-evaluable (NE) are also reported.|at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)|Best overall tumor response was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.|||Participants|||Count of Participants
2534189|NCT03248492|Secondary|Objective Response Rate as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)|The number of participants with objective response is assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment. Investigator-assessed objective response rate (ORR) was defined as the proportion of participants who achieved a best overall response of complete response or partial response based on local radiologists/investigators' tumor assessments.|at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)|Objective response rate (ORR) was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.|||Participants|||Count of Participants
2534190|NCT03248492|Primary|Objective Response Rate as Confirmed by Independent Central Review Following Intravenous Administration of 5.4 mg/kg DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)|The number of participants with objective response was assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment, by independent central imaging facility review based on RECIST version 1.1.|at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)|Objective response rate (ORR) was assessed in the Enrolled Analysis Set.at data cut-off date of 21 March 2019|||Participants|||Count of Participants
2534191|NCT03248141|Primary|Dosing Pattern||From baseline up to end of study (6 months)|Data was not collected and analyzed for this outcome measure since very less number of participants were enrolled prior to study termination.||||||
2534192|NCT03248141|Primary|Resource Utilization Pattern||From baseline up to end of study (6 months)|Data was not collected and analyzed for this outcome measure since very less number of participants were enrolled prior to study termination.||||||
2534193|NCT03247985|Secondary|Pain Score at Four Weeks|Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).|Four Weeks Postoperative||||units on a scale||Standard Deviation|Mean
2534194|NCT03247985|Secondary|Pain Score at One Week|Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).|One Week Postoperative||||units on a scale||Standard Deviation|Mean
2534195|NCT03247985|Secondary|Pain Score at Baseline|Participants were asked to rate their level of pain on a Likert scale (0 through 5; 0=no pain, 5=severe pain).|baseline||||units on a scale||Standard Deviation|Mean
2534196|NCT03247985|Primary|Number of Participants With Early Postoperative Complications|Any complication which occurred within 30 days after the operation.|Within 30 days||||participants|||Number
2534197|NCT03247985|Primary|Mean Operative Time|Length of time needed to complete surgery.|First incision to closure, approximately one hour||||minutes||Standard Deviation|Mean
2534198|NCT03247790|Secondary|PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period|PK: AUC(0-∞) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, and 72h post-dose|All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2534199|NCT03247790|Secondary|PK: Maximum Observed Drug Concentration (Cmax) of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period|PK: Cmax of Major Lasmiditan Metabolites [M3, M8, M7, (S,R)-M18and (S,S)-M18] in Each Period.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, and 72h post-dose|All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2534200|NCT03247790|Primary|PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan in Each Period|PK: AUC(0-∞) of Lasmiditan in Each Period.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8,12, 18, 24, 48, and 72h post-dose|All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2534201|NCT03247790|Primary|Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lasmiditan in Each Period|PK: Cmax of Lasmiditan in Each Period.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8,12, 18, 24, 48, and 72h post-dose|All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetic data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2534202|NCT03247738|Secondary|Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)|Platelet reactivity at 30 minutes after starting cangrelor or placebo measured by VASP and reported as platelet reactivity index (PRI%)|30 minutes||||platelet reactivity index (PRI)||95% Confidence Interval|Least Squares Mean
2534205|NCT03247673|Secondary|Additional Pharmacokinetics (Time to Cmax)|To assess the additional PK of study drugs (Time to Cmax)|pre-dose, end of infusion, 1 hour after EOI, 4, 8, 12, 24, 48, 72, 168, 336, 672, 1,008, 1,344, 1,680, 2,016, and 2,352 hours after SOI|PK population|||h||Full Range|Median
2534209|NCT03246672|Secondary|Weight|Patient weight obtained from the electronic medical record on the clinical visit date closest to the 16-week study assessment date|16 weeks|The N=30 is based on the number of participants who provided baseline data according to Intent-to-treat principles|||pounds||Standard Deviation|Mean
2534210|NCT03246672|Primary|Retention Rate|Percentage of patients with baseline data who complete 16-week outcome assessments|16-week outcome assessment||||Participants|||Count of Participants
2534211|NCT03246672|Primary|Recruitment Rate|Percentage of contacted patients who consent to be in the study|week 0|# of patients for whom phone screening was attempted|||Participants|||Count of Participants
2534212|NCT03246152|Secondary|BCVA Change|Correlation of BCVA change with degree of capillary non-perfusion before and after injections|At baseline and after 3-6 consecutive monthly injections.|Patients with good image quality|||Logmar||Standard Deviation|Mean
2534213|NCT03246152|Primary|Macular Capillary Density Change at Full Retinal Thickness|Effect of repeated intravitreal Anti-VEGF injections on macular capillary density using the change in the skeletonized vascular density and fractal dimension measured by ImageJ|At baseline and after 3-6 consecutive monthly injections.|Patients with adequate image quality|||percentage of vascularity||Standard Deviation|Mean
2534214|NCT03246152|Primary|FAZ Area Change|Effect of repeated intravitreal Anti-VEGF injections on Foveal Avascular Zone (FAZ) area measured using the freehand tool of ImageJ|At baseline and after 3-6 consecutive monthly injections.|Patients with adequate image quality|||mm^2||Standard Deviation|Mean
2534215|NCT03245762|Primary|Suck and Swallow Competency in Infants/Children With PWS Who Are in Nutritional Phase 1a|Swallow study Overall improvement|baseline to day 5||||Participants|||Count of Participants
2534216|NCT03245619|Secondary|Change From Baseline in Levels of Tryptophan Metabolites-Part C|Blood samples were planned to be collected to measure the KMO enzyme inhibition by determining the levels of the biomarkers Kyn and 3-HK.|Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18 hours post-infusion), Days2 to 7 (pre-dose), Day8 (6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180 hours post-infusion)|All Subject Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534217|NCT03245619|Secondary|Change From Baseline in Levels of Tryptophan Metabolites-Part B|Blood samples were planned to be collected to measure the KMO enzyme inhibition by determining the levels of the biomarkers Kyn and 3-HK.|Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18 hours post-infusion), Days2 to 7 (pre-dose), Day8 (6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180 hours post-infusion)|All Subject Population. Data was not collected as no participants were enrolled in Part B of the study.||||||
2534218|NCT03245619|Secondary|Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohorts 3 to 8)|Blood samples were collected to measure the KMO enzyme inhibition by determining the levels of the biomarkers Kyn and 3-HK. Baseline was the average of all pre-dose measurements (Day -1 [pre-dose at 16 hours, 14 hours, 12 hours and 10 hours] and Day 1 [pre-dose at 30 minutes and 2 hours]). Change from Baseline was calculated as value at the specified time point minus the Baseline value.|Baseline, 6, 15 and 30 minutes, 1, 1.5, 2, 3, 4.5, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose|All Subject Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled. Only those participants with data available at the specified time points were analyzed.|||Arbitrary units||Full Range|Median
2534219|NCT03245619|Secondary|Change From Baseline in Levels of Tryptophan Metabolites-Part A (Cohort 1 and 2)|Blood samples were collected to measure the kynurenine-3-monooxygenase (KMO) enzyme inhibition by determining the levels of the biomarkers Kynurenine (Kyn) and 3-hydroxykynurenine (3-HK). Baseline was the average of all pre-dose measurements (Day 1 [pre-dose at 1 hour and 30 minutes]). Change from Baseline was calculated as value at the specified time point minus the Baseline value.|Baseline, 6, 15 and 30 minutes, 1, 1.5, 2, 3, 4.5, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dose|All Subject Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles). Data was not collected for placebo arms of Cohorts 1 and 2.|||Arbitrary units||Full Range|Median
2534220|NCT03245619|Secondary|T1/2 for GSK3335065-Part C (Cohort 14)|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)|PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534221|NCT03245619|Secondary|T1/2 for GSK3335065-Part C (Cohort 13)|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose|PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534222|NCT03245619|Secondary|T1/2 for GSK3335065-Part B|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)|PK Parameter Population. Data was not collected as no participants were enrolled in Part B of the study.||||||
2534223|NCT03245619|Secondary|T1/2 for GSK3335065-Part A (Cohorts 3 to 8)|Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose|PK Parameter Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.|||Hours||Full Range|Median
2534224|NCT03245619|Secondary|Apparent Terminal Half Life (T1/2) for GSK3335065-Part A (Cohorts 1 and 2)|Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis. Data for Cohort 1 is derived only from time points up to 3 hours as later data in this participant was below limit of quantification.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dose|PK Parameter Population. Only participants with PK parameters that could be derived are summarized.|||Hours||Full Range|Median
2534225|NCT03245619|Secondary|Volume of Distribution for GSK3335065-Part C (Cohort 14)|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)|PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534226|NCT03245619|Secondary|Volume of Distribution for GSK3335065-Part C (Cohort 13)|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose|PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534227|NCT03245619|Secondary|Volume of Distribution for GSK3335065-Part B|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)|PK Parameter Population. Data was not collected as no participants were enrolled in Part B of the study.||||||
2534228|NCT03245619|Secondary|Volume of Distribution for GSK3335065-Part A (Cohorts 3 to 8)|Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose|PK Parameter Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2534229|NCT03245619|Secondary|Volume of Distribution for GSK3335065-Part A (Cohorts 1 and 2)|Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis. Data for Cohort 1 is derived only from time points up to 3 hours as later data in this participant was below limit of quantification.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dose|PK Parameter Population. Only participants with PK parameters that could be derived are summarized.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2534230|NCT03245619|Secondary|Clearance for GSK3335065-Part C (Cohort 14)|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)|PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534231|NCT03245619|Secondary|Clearance for GSK3335065-Part C (Cohort 13)|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose|PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534232|NCT03245619|Secondary|Clearance for GSK3335065-Part B|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)|PK Parameter Population. Data was not collected as no participants were enrolled in Part B of the study.||||||
2534233|NCT03245619|Secondary|Clearance for GSK3335065-Part A (Cohorts 3 to 8)|Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose|PK Parameter Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2534234|NCT03245619|Secondary|Clearance for GSK3335065-Part A (Cohorts 1 and 2)|Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis. Data for Cohort 1 is derived only from time points up to 3 hours as later data in this participant was below limit of quantification.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dose|PK Parameter Population. Only participants with PK parameters that could be derived are summarized.|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2534235|NCT03245619|Secondary|Tmax of GSK3335065-Part C (Cohort 14)|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)|PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534236|NCT03245619|Secondary|Tmax of GSK3335065-Part C (Cohort 13)|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose|PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534237|NCT03245619|Secondary|Tmax of GSK3335065-Part B|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)|PK Parameter Population. Data was not collected as no participants were enrolled in Part B of the study.||||||
2534238|NCT03245619|Secondary|Tmax of GSK3335065-Part A (Cohorts 3 to 8)|Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose|PK Parameter Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.|||Hours||Full Range|Median
2534239|NCT03245619|Secondary|Time to Reach Maximum Concentration (Tmax) for GSK3335065-Part A (Cohorts 1 and 2)|Blood samples for pharmacokinetic PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dose|PK Parameter Population|||Hours||Full Range|Median
2534240|NCT03245619|Secondary|Cmax of GSK3335065-Part C (Cohort 14)|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)|PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534241|NCT03245619|Secondary|Cmax of GSK3335065-Part C (Cohort 13)|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose|PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534242|NCT03245619|Secondary|Cmax of GSK3335065-Part B|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)|PK Parameter Population. Data was not collected as no participants were enrolled in Part B of the study.||||||
2534243|NCT03245619|Secondary|Cmax of GSK3335065-Part A (Cohorts 3 to 8)|Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose|PK Parameter Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534244|NCT03245619|Secondary|Maximum Observed Concentration (Cmax) of GSK3335065-Part A (Cohorts 1 and 2)|Blood samples for pharmacokinetic PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dose|PK Parameter Population|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534245|NCT03245619|Secondary|Tlast of GSK3335065-Part C (Cohort 14)|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)|PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534246|NCT03245619|Secondary|Tlast of GSK3335065-Part C (Cohort 13)|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose|PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534247|NCT03245619|Secondary|Tlast of GSK3335065-Part B|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)|PK Parameter Population. Data was not collected as no participants were enrolled in Part B of the study.||||||
2534248|NCT03245619|Secondary|Tlast of GSK3335065-Part A (Cohorts 3 to 8)|Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose|PK Parameter Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.|||Hours||Full Range|Median
2534249|NCT03245619|Secondary|Time of the Last Measurable Concentration (Tlast) of GSK3335065-Part A (Cohorts 1 and 2)|Blood samples for pharmacokinetic PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dose|PK Parameter Population|||Hours||Full Range|Median
2534250|NCT03245619|Secondary|AUC(0-Inf) for GSK3335065-Part C (Cohort 14)|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)|PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534251|NCT03245619|Secondary|AUC(0-Inf) for GSK3335065-Part C (Cohort 13)|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose|PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534252|NCT03245619|Secondary|AUC(0-Inf) for GSK3335065-Part B|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)|PK Parameter Population. Data was not collected as no participants were enrolled in Part B of the study.||||||
2534317|NCT03244800|Secondary|Cohort 1: Change From Baseline in Body Weight to Day 50|The changes in the body weight during the study period from baseline to Day 50 is reported.|Day 1 through Day 50|The ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.|||Kilogram||90% Confidence Interval|Least Squares Mean
2534253|NCT03245619|Secondary|AUC(0-Inf) for GSK3335065-Part A (Cohorts 3 to 8)|Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose|PK Parameter Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.|||Hours*nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534254|NCT03245619|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-Inf]) for GSK3335065-Part A (Cohorts 1 and 2)|Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis. Data for Cohort 1 is derived only from time points up to 3 hours as later data in this participant was below limit of quantification.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dose|PK Parameter Population. Only participants with PK parameters that could be derived are summarized.|||Hours*nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534255|NCT03245619|Secondary|AUC(0-t) for GSK3335065-Part C (Cohort 14)|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)|PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534256|NCT03245619|Secondary|AUC(0-t) for GSK3335065-Part C (Cohort 13)|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose|PK Parameter Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534257|NCT03245619|Secondary|AUC(0-t) for GSK3335065-Part B|Blood samples for PK analysis of GSK3335065 were planned to be collected at the indicated time points.|Day1 (Pre-dose, 6, 15, 30 minutes, 1, 2, 3, 4.5, 6, 9, 12, 18hours post-infusion), Days2 to 7 (pre-dose), Day8 (end of infusion, 6 and 12 hours post-infusion), Day9 (18, 24, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-infusion)|PK Parameter Population. Data was not collected as no participants were enrolled in Part B of the study.||||||
2534258|NCT03245619|Secondary|AUC(0-t) for GSK3335065-Part A (Cohorts 3 to 8)|Blood samples for PK analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 and 168 hours post-dose|PK Parameter Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.|||Hours*nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534259|NCT03245619|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration (AUC[0-t]) for GSK3335065-Part A (Cohorts 1 and 2)|Blood samples for pharmacokinetic (PK) analysis of GSK3335065 were collected at the indicated time points. PK parameters were calculated using standard non-compartmental analysis. PK Parameter Population comprised of all active participants whose PK sample was obtained and analyzed and who provided PK parameters.|1 hour pre-dose, 6, 12, 15, 20, and 30 minutes, 1, 2, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 60 and 72 hours post-dose|PK Parameter Population|||Hours*nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534260|NCT03245619|Primary|Number of Participants With Abnormal Vital Signs-Part C|Vital signs including SBP, DBP, heart rate, respiration rate and temperature were planned to be measured in a semi-recumbent position with a completely automated device preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.|Up to Day 34|All Subjects Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534261|NCT03245619|Primary|Number of Participants With Abnormal Vital Signs-Part B|Vital signs including SBP, DBP, heart rate, respiration rate and temperature were planned to be measured in a semi-recumbent position with a completely automated device preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions.|Up to Day 34|All Subjects Population. Data was not collected as no participants were enrolled in Part B of the study.||||||
2534262|NCT03245619|Primary|Number of Participants With Abnormal Vital Signs-Part A|"Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate, respiration rate and temperature were measured in a semi-recumbent position with a completely automated device preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Participants are counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Data for worst case post-Baseline relative to Baseline is presented. Baseline was defined as the latest pre-dose assessment. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan."|Up to Day 22|All Subject Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.|||Participants|||Count of Participants
2534263|NCT03245619|Primary|Number of Participants With Abnormal ECG Findings-Part C|Triplicate 12-lead ECGs were planned to be obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, QTcF and QTcB intervals.|Up to Day 34|All Subjects Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534264|NCT03245619|Primary|Number of Participants With Abnormal ECG Findings-Part B|Triplicate 12-lead ECGs were planned to be obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, QTcF and QTcB intervals.|Up to Day 34|All Subjects Population. Data was not collected as no participants were enrolled in Part B of the study.||||||
2534304|NCT03244800|Secondary|Cohort 2: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382|The time to reach the maximum observed concentration of MEDI0382 is reported.|Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14|The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The “Number Analyzed” denotes the number of participants analyzed at the specified time point for this outcome measure.|||Hours||Full Range|Median
2534265|NCT03245619|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part A|Triplicate 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, QT interval corrected using Fridericia's formula (QTcF) and Bazett's QT interval corrected for heart rate (QTcB). ECG measurements were preceded by at least 5 minutes rest for the participant in a semi-recumbent position. Number of participants with abnormal-clinically significant and abnormal-not clinically significant ECG findings at worst case post-Baseline is presented. Baseline was defined as the latest pre-dose assessment. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.|Up to Day 22|All Subject Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.|||Participants|||Count of Participants
2534266|NCT03245619|Primary|Number of Participants With Abnormal Urine Parameters-Part C|Urine samples were planned to be collected for the assessment of urine parameters.|Up to Day 34|All Subjects Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534267|NCT03245619|Primary|Number of Participants With Abnormal Urine Parameters-Part B|Urine samples were planned to be collected for the assessment of urine parameters.|Up to Day 34|All Subjects Population. Data was not collected as no participants were enrolled in Part B of the study.||||||
2534268|NCT03245619|Primary|Number of Participants With Abnormal Urine Parameters-Part A|Urine samples were taken for the assessment of following urine parameters: specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick method. Microscopic examination was performed and collected for any abnormal dipstick results. Number of participants with abnormal urine parameters any time post-Baseline is presented. Baseline was defined as the latest pre-dose assessment. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.|Up to Day 22|All Subject Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.|||Participants|||Count of Participants
2534269|NCT03245619|Primary|Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part C|Blood samples were planned to be collected for the assessment of clinical chemistry parameters.|Up to Day 34|All Subjects Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534270|NCT03245619|Primary|Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part B|Blood samples were planned to be collected for the assessment of clinical chemistry parameters.|Up to Day 34|All Subjects Population. Data was not collected as no participants were enrolled in Part B of the study.||||||
2534271|NCT03245619|Primary|Number of Participants With Clinical Chemistry Parameters of Potential Clinical Importance-Part A|Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: albumin (low: <30 millimoles per liter [mmol/L]); alanine aminotransferase (ALT) (high: >=2xupper limit of normal [ULN]); aspartate aminotransferase (AST) (high: >=2xULN); alkaline phosphatase (ALP) (high: >=2xULN); total bilirubin (high: >=1.5xULN); calcium (low: <2 mmol/L and high: >2.75 mmol/L); glucose (low: <3 mmol/L and high: >9 mmol/L); potassium (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Data for worst-case post-Baseline is presented. Baseline was defined as the latest pre-dose assessment. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.|Up to Day 22|All Subject Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.|||Participants|||Count of Participants
2534272|NCT03245619|Primary|Number of Participants With Hematological Parameters of Potential Clinical Importance-Part C|Blood samples were planned to be collected for the assessment of hematology parameters.|Up to Day 34|All Subjects Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534273|NCT03245619|Primary|Number of Participants With Hematological Parameters of Potential Clinical Importance-Part B|Blood samples were planned to be collected for the assessment of hematology parameters.|Up to Day 34|All Subjects Population. Data was not collected as no participants were enrolled in Part B of the study.||||||
2534274|NCT03245619|Primary|Number of Participants With Hematological Parameters of Potential Clinical Importance-Part A|Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: hematocrit (high: >0.54 proportion of red blood cells in blood); hemoglobin (high: >180 grams per liter [g/L]), lymphocytes (low: <0.8x10^9 cells per liter [cells/L]); neutrophil count (low: <1.5x10^9 cells/L); platelet count (low: <100x10^9 cells/L and high: >550x10^9 cells/L); white blood cells count (low: <3x10^9 cells/L and high: >20x10^9 cells/L). Data for worst-case post-Baseline is presented. Baseline was defined as the latest pre-dose assessment. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.|Up to Day 22|All Subject Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.|||Participants|||Count of Participants
2534275|NCT03245619|Primary|Number of Participants With AEs and SAEs-Part C|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. AEs and SAEs were planned to be collected from admission until follow-up.|Up to Day 34|All Subjects Population. Data was not collected as no participants were enrolled in Part C of the study.||||||
2534276|NCT03245619|Primary|Number of Participants With AEs and SAEs-Part B|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. AEs and SAEs were planned to be collected from admission until follow-up.|Up to Day 34|All Subjects Population. Data was not collected as no participants were enrolled in Part B of the study.||||||
2571621|NCT02513732|Secondary|Reference Vessel Diameter|Reference vessel diameter measured by QCA|Pre-procedure|ITT population.|||mm|Number of lesions|Standard Deviation|Mean
2534277|NCT03245619|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part A|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. All Subject Population comprised of all participants randomized to treatment who received at least one dose of study treatment. AEs and SAEs were collected from admission until follow-up. Placebo arms across similar dosing strategies were combined as pre-specified in reporting and analysis plan.|Up to Day 22|All Subject Population. Data was not collected for Cohorts 4 to 8 as no participants were enrolled.|||Participants|||Count of Participants
2534278|NCT03245463|Secondary|PROMIS Physical Health Score|The physical health score will be surveyed using the PROMIS-10 global health questionnaire. A higher score indicates better physical health. Scores range from 16.2 to 67.7.|3 months post-injection||||score on a scale||Standard Deviation|Mean
2534279|NCT03245463|Secondary|Number of Patients Who Believed That the Education They Received Helped With the Care of Their Osteoarthritis|"Patient will be asked: Did the education you received help with the care of your osteoarthritis?"|3 months post-injection||||Participants|||Count of Participants
2534280|NCT03245463|Secondary|Number of Patients Who Would Have Preferred a Different Method of Receiving Education.|"Patient will be asked: Would you have preferred a different method of receiving education?"|3 months post-injection||||Participants|||Count of Participants
2534281|NCT03245463|Primary|Patient Satisfaction With the Teaching Method|Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.|3 months post-injection||||units on a scale||Standard Deviation|Mean
2534282|NCT03245463|Primary|Provider Satisfaction With the Teaching Method|Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.|1 month post-injection||||units on a scale||Standard Deviation|Mean
2534283|NCT03245463|Primary|Patient Satisfaction With the Teaching Method|Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.|1 month post-injection||||units on a scale||Standard Deviation|Mean
2534284|NCT03245398|Other Pre-specified|Distribution of Hookworm Species Among Participants|Genetic differentiation between Necator americanus and Ancylostoma duodenale using PCRs will allow us to identify which of the species is most prevalent.|1 year|||||||
2534285|NCT03245398|Other Pre-specified|Prevalence of Genetic Resistance Markers Among Participants|The same two aliquots of stool will be used in this section.. Additionally, a Harada Mori culture will be prepared from one of the stool samples of each child at baseline and at follow-up to extract hatched larvae. Larvae will be stored in ethanol. Both stool and larvae samples will undergo an assessment of drug resistance-associated single-nucleotide polymorphisms.|2 years|||||||
2534286|NCT03245398|Other Pre-specified|Comparison of the Sensitivity of Kato Katz to Quantitative Polymerase Chain Reaction (PCR) Assays|Two aliquots (about 1 g of stool each) of positive samples will be stored in ethanol and transported to the Swiss Tropical Public Health Institute for subsequent DNA extraction and diagnostic.|1 year|||||||
2534287|NCT03245398|Secondary|Arithmetic ERR of Both Mebendazole Regimens Against Ascaris Lumbricoides|"Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(arithmetic mean EPG at follow-up/arithmetic mean EPG at baseline))*100). Note: in contrast to the publication the outcome measure entry mask requires the complementary percentage: (arithmetic mean at follow-up/arithmetic mean at baseline)*100)."|baseline (before treatment) and 18 to 22 days post-treatment||||percentage change||95% Confidence Interval|Mean
2534288|NCT03245398|Secondary|Arithmetic ERR of Both Mebendazole Regimens Against Trichuris Trichiura|"Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(arithmetic mean EPG at follow-up/arithmetic mean EPG at baseline))*100). Note: in contrast to the publication the outcome measure entry mask requires the complementary percentage: (arithmetic mean at follow-up/arithmetic mean at baseline)*100)."|baseline (before treatment) and 18 to 22 days post-treatment||||percentage change||95% Confidence Interval|Mean
2534289|NCT03245398|Secondary|Arithmetic ERR of the Two Regimens of Mebendazole Against Hookworm|"Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(arithmetic mean EPG at follow-up/arithmetic mean EPG at baseline))*100). Note: in contrast to the publication the outcome measure entry mask requires the complementary percentage: (arithmetic mean at follow-up/arithmetic mean at baseline)*100)."|baseline (before treatment) and 18 to 22 days post-treatment||||percentage change||95% Confidence Interval|Mean
2534290|NCT03245398|Secondary|Geometric ERR of Both Mebendazole Regimens Against Ascaris Lumbricoides.|"Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))*100). Note: in contrast to the publication the outcome measure entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)*100)."|baseline (before treatment) and 18 to 22 days post-treatment||||percentage change||95% Confidence Interval|Mean
2534291|NCT03245398|Secondary|Cure Rate (CR) of Both Mebendazole Regimens Against Ascaris Lumbricoides|Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.|baseline (before treatment) and 18 to 22 days post-treatment||||percentage of participants cured||95% Confidence Interval|Number
2534471|NCT03237871|Primary|Mean Number of Questions to Which Participant Respond in Each Survey in Week 1|Mean number of questions to which enrolled participant respond in each survey in Week 1.|Week 1|Mean number of participants enrolled in the study who responded to the survey in week 1|||Mean number of responded questions||Standard Deviation|Mean
2534292|NCT03245398|Secondary|Geometric ERR of Both Mebendazole Regimens Against Trichuris Trichiura|"Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))*100). Note: in contrast to the publication the outcome measure entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)*100)."|baseline (before treatment) and 18 to 22 days post-treatment||||percentage of change||95% Confidence Interval|Mean
2534293|NCT03245398|Secondary|CR of Both Mebendazole Regimens Against Trichuris Trichiura|Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.|baseline (before treatment) and 18 to 22 days post-treatment||||percentage of participants cured||95% Confidence Interval|Number
2534294|NCT03245398|Secondary|Geometric Mean Egg Reduction Rate (ERR) of the Two Regimens of Mebendazole Against Hookworm|"Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))*100). Note: in contrast to the publication the outcome measure entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)*100)."|baseline (before treatment) and 18 to 22 days post-treatment||||percentage change||95% Confidence Interval|Geometric Mean
2534295|NCT03245398|Primary|Cure Rate (CR) of Mebendazole Against Hookworm|Cure rates (CRs) will be calculated as the percentage of egg-positive participants at baseline who become egg-negative after treatment.|baseline (before treatment) and 18 to 22 days post-treatment||||percentage of participants cured||95% Confidence Interval|Number
2534296|NCT03244865|Primary|Fetal Heart Rate With the Laborview System Versus the CTG Monitor - Pilot Comparison Study|Using standard of care CTG (Cardiotocography) already in place and the LaborView electrode-based FHR monitoring simultaneously, we will collect FHR data from both monitors simultaneously. We will compare the two FHR calculations using root mean squared error (RMSE).|1 - 8 hours||||beats per minute||90% Confidence Interval|Mean
2534297|NCT03244800|Secondary|Cohort 1 and Cohort 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0382|Participants with positive serum antibodies to MEDI0382 are reported.|Baseline (Day 1), Day 29, Day 50, and Follow-up Visit 2 (28 days after the last dose [approximately 64 days])|As-treated population included all participants who received any study drug and were analyzed according to the treatment they received. The “Number Analyzed” denotes the number of participants analyzed at the specified time point for this outcome measure.|||Participants|||Count of Participants
2534298|NCT03244800|Secondary|Cohort 2: Trough Plasma Concentration (Ctrough) of MEDI0382|Trough plasma concentration is the measured concentration from the plasma concentration time data at the end of a dosing interval at steady state.|Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14|The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The “Number Analyzed” denotes the number of participants analyzed at the specified time point for this outcome measure.|||ng/mL||Full Range|Geometric Mean
2534299|NCT03244800|Secondary|Cohort 1: Trough Plasma Concentration (Ctrough) of MEDI0382|Trough plasma concentration is the measured concentration from the plasma concentration-time data at the end of a dosing interval at steady state.|Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49|The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The “Number Analyzed” denotes the number of participants analyzed at the specified time point for this outcome measure.|||ng/mL||Full Range|Geometric Mean
2534300|NCT03244800|Secondary|Cohort 2: Accumulation Ratio of MEDI0382|The Racc was calculated using the AUC method which account for the overall exposure measured using the specified time points on Day 1, Day 7 and Day 14. Racc was calculated using the formulas: Racc of Day 7 = AUCt of Day 7/AUCt of Day 1; Racc of Day 14 = AUCt of Day 14/AUCt of Day 1.|Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14|The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The “Number Analyzed” denotes the number of participants analyzed at the specified time point for this outcome measure.|||Ratio||Full Range|Geometric Mean
2534301|NCT03244800|Secondary|Cohort 1: Accumulation Ratio (Racc) of MEDI0382|The Racc was calculated using the AUC method which account for the overall exposure measured using the specified time points on Day 22 and Day 49. Racc was calculated using the formula, Racc of Day 49 = AUCt of Day 49/AUCt of Day 22.|Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49|The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The “Number Analyzed” denotes the number of participants analyzed at the specified time point for this outcome measure.|||Ratio||Full Range|Geometric Mean
2534302|NCT03244800|Secondary|Cohort 2: Terminal Half Life (t1/2) of MEDI0382|The t1/2 is the time measured for the concentration to decrease by one half after the dose of MEDI0382.|Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14|The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The “Number Analyzed” denotes the number of participants analyzed at the specified time point for this outcome measure.|||Hours||Full Range|Geometric Mean
2534303|NCT03244800|Secondary|Cohort 1: Terminal Half Life (t1/2) of MEDI0382|The t1/2 is the time measured for the concentration to decrease by one half after the dose of MEDI0382.|Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49|The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The “Number Analyzed” denotes the number of participants analyzed at the specified time point for this outcome measure.|||Hours||Full Range|Geometric Mean
2534316|NCT03244800|Secondary|Cohort 1: Percentage of Participants Achieving Greater Than or Equal to 5% Body Weight Loss From Baseline to Day 50|Participants achieving greater than or equal to 5% body weight loss from baseline to Day 50 is reported.|Day 1 through Day 50|The ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.|||Percentage of Participants|||Number
2534305|NCT03244800|Secondary|Cohort 1: Time to Reach Maximum Observed Concentration (Tmax) of MEDI0382|The time to reach the maximum observed concentration of MEDI0382 is reported.|Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49|The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The “Number Analyzed” denotes the number of participants analyzed at the specified time point for this outcome measure.|||Hours||Full Range|Median
2534306|NCT03244800|Secondary|Cohort 2: Maximum Observed Concentration (Cmax) of MEDI0382|The maximum observed concentration of MEDI0382 is reported.|Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14|The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The “Number Analyzed” denotes the number of participants analyzed at the specified time point for this outcome measure.|||ng/mL||Full Range|Geometric Mean
2534307|NCT03244800|Secondary|Cohort 1: Maximum Observed Concentration (Cmax) of MEDI0382|The maximum observed concentration of MEDI0382 is reported.|Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49|The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The “Number Analyzed” denotes the number of participants analyzed at the specified time point for this outcome measure.|||ng/mL||Full Range|Geometric Mean
2534308|NCT03244800|Secondary|Cohort 2: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382|The area under the concentration-time curve during the dosing interval of MEDI0382 is reported.|Cohort 2: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 1, 7, and 14|The PK population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The “Number Analyzed” denotes the number of participants analyzed at the specified time point for this outcome measure.|||ng*hr/mL||Full Range|Geometric Mean
2534309|NCT03244800|Secondary|Cohort 1: Area Under the Concentration-time Curve During the Dosing Interval (AUCt) of MEDI0382|The area under the concentration-time curve during the dosing interval of MEDI0382 is reported.|Cohort 1: Predose and 1, 2, 4, 6, 8, and 12 hours postdose on Days 22 and 49|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK sample with a value above lower limit of quantification. The “Number Analyzed” denotes the number of participants analyzed at the specified time point for this outcome measure.|||ng*hr/mL||Full Range|Geometric Mean
2534310|NCT03244800|Secondary|Cohort 1 and Cohort 2: Number of Participants With Injection Site Erythema|The injection site reactions observed during study visits were reported. Injection site reactions included (but are not limited to) local erythema, pain, tenderness, induration, swelling, pruritus, ulceration, and pigmentation.|From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)|As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.|||Participants|||Count of Participants
2534311|NCT03244800|Secondary|Cohort 1 and Cohort 2: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator as medically significant was reported as an AE. Laboratory evaluations included haematology, serum chemistry, and urinalysis.|From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)|As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.|||Participants|||Count of Participants
2534312|NCT03244800|Secondary|Cohort 1 and Cohort 2: Number of Participants With Abnormal Electrocardiogram Reported as TEAEs|Treatment-emergent adverse events observed in participants with clinically significant ECG abnormalities are reported.|From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)|As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.|||Participants|||Count of Participants
2534313|NCT03244800|Secondary|Cohort 1 and Cohort 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs|Treatment-emergent adverse events observed in participants with clinically significant vital signs abnormalities are reported. Vital sign parameters included blood pressure, heart rate, body temperature, and respiration rate.|From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)|As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.|||Participants|||Count of Participants
2534314|NCT03244800|Secondary|Cohort 1 and Cohort 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first doses of study drug through 7 to 14 days after the last dose of study drug (approximately 64 days).|From Day 1 through 7 to 14 days after the last dose of study drug (approximately 64 days)|As-treated population included all participants who received any study drug and were analyzed according to the treatment they received.|||Participants|||Count of Participants
2534315|NCT03244800|Secondary|Cohort 1 and Cohort 2: Percent Change From Baseline in MMTT Plasma Glucose AUC 0-4h to Day 7|The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) evaluation to Day 7 is reported.|Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal|The PD population included all participants who received at least one dose of study drug and had at least one post-baseline MMTT PD sample or PD evaluation. The number of participants analyzed at the specified time point for this outcome measure are reported.|||Percent change||Standard Deviation|Mean
2537974|NCT03118739|Other Pre-specified|Baseline MRI Variables - LV End-diastolic Volume||Baseline|Total number differs from Study totals due to subject non compliance with MRI (exam not completed)|||mL||Standard Deviation|Mean
2534318|NCT03244800|Secondary|Cohort 1: Change From Baseline in Fasting Plasma Glucose to Day 49|The changes in the fasting plasma glucose level during the study period from baseline to Day 49 is reported.|Baseline (Day -1) through Day 49|The ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.|||mg/dL||90% Confidence Interval|Least Squares Mean
2534319|NCT03244800|Secondary|Cohort 1: Change From Baseline in Glycated Haemoglobin (HbA1c) to Day 49|The change from baseline in Glycated haemoglobin (HbA1c) to Day 49 is reported.|Baseline (Day -1) through Day 49|The ITT population included all participants who received any study drug and were analyzed according to their randomized treatment group.|||Percentage change||90% Confidence Interval|Least Squares Mean
2534320|NCT03244800|Primary|Cohort 1: Percent Change From Baseline in Body Weight to Day 50|The percent change in body weight from baseline to Day 50 is reported.|Day 1 through Day 50|Intent-to-treat (ITT) population included all participants who received any study drug and were analyzed according to their randomized treatment group.|||Percent change||95% Confidence Interval|Least Squares Mean
2534321|NCT03244800|Primary|Cohort 1: Percent Change From Baseline in Plasma Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours (AUC0-4h) by Mixed-meal Tolerance Test (MMTT) to Day 49|The MMTT test involved the consumption of a standardised liquid meal within 5 minutes and timed serial blood samples obtained for the measurement of glucose and parameters related to glucose metabolism through 240 minutes after consumption of the standardised meal (with no additional food intake during this time). The percent change in the MMTT plasma glucose AUC 0-4h from the baseline (Day -1) to Day 49 is reported.|Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised liquid meal|Pharmacodynamic (PD) population included all participants who received at least one dose of study drug and had at least one post-baseline MMTT PD sample or PD evaluation.|||Percent change||95% Confidence Interval|Least Squares Mean
2534322|NCT03243981|Secondary|Change From Baseline in Transepidermal Water Loss as a Measure of Skin Rejuvenation|Transepidermal water loss assessment with VapoMeter.|Baseline, day 84|Data were not collected for this outcome||||||
2534323|NCT03243981|Secondary|Change From Baseline in Cutometry as a Measure of Skin Rejuvenation|Elasticity of skin assessment with cutometric probe.|Baseline, day 84|Data were not collected for this outcome||||||
2534324|NCT03243981|Secondary|Change From Baseline in Physician Global Assessment as a Measure of Skin Rejuvenation|Physician global assessment was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more severe skin aging.|Baseline, day 84|Participants that had assessments at baseline and day 84 are included in the analysis|||score on a scale||Standard Deviation|Mean
2534325|NCT03243981|Secondary|Change From Baseline in Sagging Score as a Measure of Skin Rejuvenation|Sagging was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more sagging.|Baseline, day 84|Participants that had assessments at baseline and day 84 are included in the analysis|||score on a scale||Standard Deviation|Mean
2534326|NCT03243981|Secondary|Change From Baseline in Coarse Wrinkling Score as a Measure of Skin Rejuvenation|Wrinkling was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more wrinkling.|Baseline, day 84|Participants that had assessments at baseline and day 84 are included in the analysis|||score on a scale||Standard Deviation|Mean
2534327|NCT03243981|Secondary|Change From Baseline in Fine Wrinkling Score as a Measure of Skin Rejuvenation|Wrinkling was assessed on a 10 point Likert scale (range 1-10); higher scores correspond to more wrinkling.|Baseline, day 84|Participants that had assessments at baseline and day 84 are included in the analysis|||score on a scale||Standard Deviation|Mean
2534328|NCT03243981|Primary|Number of Genes With Significant Change in Gene Transcription|The endpoint consisted of clinical inspection of biopsies of untreated skin and skin after three treatments. Genes were considered altered if a statistically significant change in transcription of an individual gene was observed between the treated and untreated skin (significance was set at p<0.01, adjusted for false discovery rate). The values in the table represent the total number of recorded genes with significant change.|16 weeks||||genes|||Number
2534329|NCT03243084|Secondary|Change in Pain Rating on the Visual Analog Scale Before and After 40-minute Stimulation|Self reported pain rating using a Visual Analog Scale (VAS) ranging from 0-10 done before and after stimulation with '0' being no pain and '10' as bad as it could be. Lower values represent a better outcome. (Pain difference was normalized using modulation index to account for ordinal scale)|before and after 40 minute stimulation session||||units on a scale||Standard Deviation|Mean
2534330|NCT03243084|Primary|Change in Electroencephalogram Power in Alpha Band Before and After 40-minute Stimulation|Changes in the EEG power in the alpha (8-12 Hz) band before and after 40-minute stimulation|5 minute recordings before and after each 40-minute stimulation at each session.||||square microvolts||Standard Deviation|Mean
2534331|NCT03243084|Primary|Change in Heart Rate Variability Before and After 40-minute Stimulation|Changes in parasympathetic tone, increase in high frequency band input via spectral analysis on EKG recordings between active and sham stimulation|before and after 40-minute stimulation at each session||||ms^2||Standard Deviation|Mean
2534332|NCT03242941|Secondary|Termination of Atrial Tachyarrhythmia.|Termination of atrial tachyarrhythmia.|30 minutes|Patients treated with the new dual stage pacing algorithm|||AF termination occurrence|AF termination occurrence||Count of Units
2534333|NCT03242941|Secondary|Localized Atrial Capture|"To assess Localized Atrial Capture the following endpoints will be considered:~- the number of AF episodes in which local capture is recorded during atrial septal stimulation in at least one of the electrode positions"|30 minutes|Patient treated with the new pacing scheme algorithm|||Episodes|Episodes||Count of Units
2534334|NCT03242941|Primary|Number of Electrodes in a Stable Position|To assess Pacing Site Stability, the number of interatrial septal pacing electrodes which are successfully placed in a stable position, will be counted. A stable position in this study is defined as a location where the pacing threshold will be < 10 mA at a pacing pulse width of 1 msec. Stable pacing further requires that no ventricular capture will be induced during atrial stimulation at twice the atrial capture threshold.|30 minutes|The maximum number of electrode pairs used and potentially stable|||Electrode pairs|Electrode pairs||Count of Units
2534739|NCT03233438|Secondary|Number of Participants With Infection-related Outpatient Healthcare Visits||44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.|||Participants|||Count of Participants
2534335|NCT03242590|Primary|Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range|The primary efficacy endpoint and analysis for this study was the percentage of LPCN 1021 treated subjects who had achieved a 24-hour average serum T concentration within the normal range of 300 to 1080 ng/dL at Visit 4, (Day 24 ± 4 days).|Following 24 days of treatment|Safety Set|||Percent of participants||95% Confidence Interval|Number
2534336|NCT03242434|Primary|Change From 0 to 5 Hours, and 0 to 24 Hours in the Ratio of Lactulose/Mannitol Over Time for Thermal Injury Participants|Urine samples were collected at indicated time-points to determine the impact of thermal injury on the magnitude of small intestine permeability following the injury. As, L/M does not get metabolized, it gets filtered in the kidney and excreted in the urine. Baseline value was considered as Day 1 for both the groups. Change from Baseline is equal to post-Baseline visit value minus Baseline value.|0 to 5 hours on Days 3, 5, 7, 11, 13 and 0 to 24 hours on Days 3, 5, 7, 9, 11 and 13|Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Ratio||Standard Deviation|Mean
2534337|NCT03242434|Primary|Change From 0 to 5 Hours, and 0 to 24 Hours in the Ratio of Lactulose/Mannitol Over Time for Healthy Participants|Urine samples were collected at indicated time-points to determine the impact of thermal injury on the magnitude of small intestine permeability following the injury. As, L/M does not get metabolized, it gets filtered in the kidney and excreted in the urine. Baseline value was considered as Day 1 for both the groups. Change from Baseline is equal to post-Baseline visit value minus Baseline value.|0 to 5 hours and 0 to 24 hours on Day 8 and Day 15|Evaluable Population. Only those participants with data available at the specified data points were analyzed.|||Ratio||Standard Deviation|Mean
2534338|NCT03242434|Primary|Change From 0 to 5 Hours, and 0 to 24 Hours in the Ratio of Lactulose/Mannitol on Day 1|Urine samples were collected at indicated time-points to determine the impact of thermal injury on the magnitude of small intestine permeability following the injury. As, L/M does not get metabolized, it gets filtered in the kidney and excreted in the urine. The impact of injury in thermal injury participants was compared with healthy participants using L/M ratio in urine.|0 to 5 hours and 0 to 24 hours on Day 1|Evaluable Population included of all participants in the safety population excluding any healthy volunteers that received any concomitant medication or food and drink containing Sugar Test Material (STM) as identified by review of the protocol deviation. Only those participants with data available at the specified data points were analyzed.|||Ratio||Standard Deviation|Mean
2534339|NCT03242408|Primary|Percent of LPCN 1021-treated Subjects Who Achieve a Total Testosterone Average Concentration [Cavg] in the Normal Range|Safety Set; Proportion of LPCN 1021-treated subjects who achieve a total testosterone average concentration [Cavg] in the normal range|Following 24 days of treatment|Safety Set|||Percent of participants||95% Confidence Interval|Number
2534340|NCT03240575|Secondary|Peak 0-3 Hours Forced Expiratory Volume in One Second (FEV1) Response (Change From Baseline) [L] After 12 Weeks Treatment|Peak 0-3 hours Forced Expiratory Volume in one second (FEV1) response (change from baseline) [L] after 12 weeks treatment. Peak 0-3h was defined as the maximum value measured within the first three hours post doing.|30 minutes, 1 h, 2h and 3h post dose at baseline and week 12.|Full Analysis Set (FAS): FAS included all patients in the TS who had baseline and at least one post-baseline measurement for at least one efficacy parameter. The Mixed-effects model repeated measurement (MMRM) model defined the participants who contributed to the model.|||Litre (L)||Standard Error|Mean
2534341|NCT03240575|Secondary|Trough Forced Expiratory Volume in One Second (FEV1) Response (Change From Baseline) [L] After 12 Weeks Treatment|Trough Forced Expiratory Volume in one second (FEV1) response (change from baseline) [L] after 12 weeks treatment. Trough FEV1 was defined as the mean of the FEV1 value measured at 23 hours and at 24 hours after the trial medication administration. Through FEV1 response (change from baseline) was defined as trough FEV1 minus baseline FEV1.|At 23 h and 24 h post dose at baseline and at 23h and 24 h post dose at week 12.|Full Analysis Set (FAS): FAS included all patients in the TS who had baseline and at least one post-baseline measurement for at least one efficacy parameter. The Mixed-effects model repeated measurement (MMRM) model defined the participants who contributed to the model.|||Litre (L)||Standard Error|Mean
2534342|NCT03240575|Secondary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 12 Hours (AUC0-12) Response (Change From Baseline) [L] After 12 Weeks of Treatment|"Forced Expiratory Volume in one second (FEV1) Area under the Curve from 0 to 12 hours (AUC0-12) response (change from baseline) [L] after 12 weeks of treatment.~FEV1 AUC0-12 was calculated as the area under the FEV1-time curve from 0-12 hours post-dose using the trapezoidal rule, divided by the duration (12 hours) and reported in liters. FEV1 AUC0-12 response (change from baseline) was defined as FEV1 AUC0-12 minus baseline FEV1."|1 hours (h) and 10 minutes (min) before first dose at day1 of weeks 1 for baseline. 10 min before and 30 min, 1 h, 2h, 3h, 4h, 6h, 8h, 10h, 11h 50min post morning dose at week 12.|Full Analysis Set (FAS): FAS included all patients in the TS who had baseline and at least one post-baseline measurement for at least one efficacy parameter. The Mixed-effects model repeated measurement (MMRM) model defined the participants who contributed to the model.|||Litre*hours (L*h)||Standard Error|Mean
2534343|NCT03240575|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 24 Hours (AUC0-24) Response (Change From Baseline) [L] After 12 Weeks of Treatment|Forced Expiratory Volume in one second (FEV1) Area under the Curve from 0 to 24 hours (AUC0-24) response (change from baseline) [L] after 12 weeks of treatment. FEV1 AUC0-24 was calculated as the area under the FEV1-time curve from 0-24 hours post-dose using the trapezoidal rule, divided by the duration (24 hours) and reported in liters. FEV1 AUC0-24 response (change from baseline) was defined as FEV1 AUC0-24 mius baseline FEV1.|1 hours (h) and 10 minutes (min) before first dose at day1 of weeks 1 for baseline.10 min before and 30 min, 1 h, 2h, 3h, 4h, 6h, 8h, 10h, 11h 50min, 12h 30 min, 13h, 14h, 22h, 23h, and 24h post morning dose at week 12.|Full Analysis Set (FAS): FAS included all patients in the TS who had baseline and at least one post-baseline measurement for at least one efficacy parameter. The Mixed-effects model repeated measurement (MMRM) model defined the participants who contributed to the model.|||Litre*hours (L*h)||Standard Error|Mean
2534433|NCT03238911|Secondary|Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35|"Safety~Change in 1,25-Dihydroxyvitamin D (vitamin D 1.25) from baseline to days 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||pg/mL||Standard Deviation|Mean
2534344|NCT03239873|Secondary|Percentage of Participants With Medically-Attended Adverse Events (Incidence ≥5%)|The percentage of participants with medically-attended AEs up to ~180 days after vaccination 2 that did not meet the definition of serious adverse event (incidence ≥5% in one or more vaccination groups) was reported.|Up to ~180 days after vaccination 2 (Up to ~285 days)|The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.|||Percentge of Participants|||Number
2534345|NCT03239873|Secondary|Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 2 (Incidence > 0%)|The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.|Up to 42 days after vaccination 2|The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.|||Percentage of Participants|||Number
2534346|NCT03239873|Secondary|Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 1 (Incidence > 0%)|The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.|Up to 42 days after vaccination 1|The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.|||Percentage of Participants|||Number
2534347|NCT03239873|Secondary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event|The percentage of participants discontinued from the study due to an adverse event for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.|Up to 42 days after vaccination 1 and up to 42 days after vaccination 2|The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.|||Percentage of Participants|||Number
2534348|NCT03239873|Secondary|Percentage of Participants With One or More Vaccine-Related Serious Adverse Events|The percentage of participants with one or more vaccine-related serious adverse events up to ~180 days after vaccination 2 was reported. The study investigator determines whether the serious adverse event is related to the vaccine.|Up to ~180 days after vaccination 2|The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.|||Percentage of Participants|||Number
2534349|NCT03239873|Secondary|Percentage of Participants With a ≥4-fold Rise From Baseline in Varicella Zoster Virus Antibody Titers in Participants Initially Seropositive to Varicella Zoster Virus Antibody|The percentage of participants with a geometric mean ≥4-fold rise from baseline of ≥1.25gpELISA units/mL in VZV antibody titer at approximately 43 days after vaccination 1 was assessed.|Baseline and 6 weeks (~43 days) after vaccination 1|The analysis population consisted of all participants with seropositive antibody titer (≥1.25gpELISA units/mL) and available postvaccination serology data.|||Percentage of Participants||95% Confidence Interval|Geometric Mean
2534350|NCT03239873|Secondary|Geometric Mean Fold Rise From Baseline in Varicella Zoster Virus Antibody Titer in Participants Initially Seropositive to Varicella Zoster Virus Antibody|Blood samples were taken at pre-vaccination (baseline) and approximately 43 days after vaccination 1 to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA. The geometric mean fold rise (GMFR) was calculated as GMT post vaccination 1/GMT pre-vaccination (baseline). Confidence interval is calculated if there are at least 5 subjects who are seropositive.|Baseline and 6 weeks (~43 days) after vaccination 1|The analysis population consisted of all participants with with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and with available postvaccination serology data.|||Ratio||95% Confidence Interval|Geometric Mean
2534351|NCT03239873|Secondary|Percentage of Participants With Immunogenicity to Varicella Zoster Virus in Participants Initially Seropositive to Varicella Zoster Virus Antibody (≥ 5gpELISA Units/mL)|The percentage of participants with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and postvaccination serology contributing to the per-protocol analysis was assessed. Confidence interval is calculated if there are at least 5 subjects who are seropositive. Antibody titers were assessed using gpELISA.|6 weeks (~43 days) after vaccination 1|The analysis population consisted of all participants with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and with available postvaccination serology data.|||Percentage of Participants||95% Confidence Interval|Number
2534352|NCT03239873|Secondary|Percentage of Participants With One or More Systemic Adverse Events After Vaccination 2 (Incidence > 0)|All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 2. The percentage of participants with one or more systemic adverse events was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.|Up to 42 days after vaccination 2|The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.|||Percentage of Participants|||Number
2534353|NCT03239873|Secondary|Percentage of Participants With One or More Systemic Adverse Events After Vaccination 1 (Incidence ≥ 4)|All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 1. The percentage of participants with one or more systemic adverse events (incidence ≥4 participants in one or more of the vaccination groups) was reported.|Up to 42 days after vaccination 1|The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.|||Percentage of Participants|||Number
2534354|NCT03239873|Secondary|Percentage of Participants With One or More Vaccine-Related Adverse Events|The percentage of participants with one or more vaccine-related adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.|Up to 42 days after vaccination 1 and up to 42 days after vaccination 2|The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.|||Percentage of Participants|||Number
2537975|NCT03118739|Other Pre-specified|Baseline MRI Variables - Kidney Cortex T2 Star||Baseline|Total number differs from Study totals due to subject non compliance with MRI (exam not completed)|||ms||Standard Deviation|Mean
2534355|NCT03239873|Secondary|Percentage of Participants With One or More Serious Adverse Events|A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants with one or more SAEs ~180 days after vaccination 2 was reported.|Up to ~180 days after vaccination 2 (Up to ~285 days)|The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.|||Percentage of Participants|||Number
2534356|NCT03239873|Secondary|Percentage of Participants With One or More Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.|Up to 42 days after vaccination 1 and up to 42 days after vaccination 2|The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.|||Percentage of Participants|||Number
2534357|NCT03239873|Secondary|Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2|The percentage of participants with solicited (Vaccine Report Card) injection-site erythema, injection-site swelling, and injection-site pain/tenderness was assessed.|Up to 5 days after vaccination 2|The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.|||Percentage of Participants|||Number
2534358|NCT03239873|Secondary|Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, or Injection-site Pain/Tenderness After Vaccination 1|The percentage of participants with solicited (on a Vaccine Report Card) injection-site erythema, injection-site swelling, or injection-site pain/tenderness was assessed.|Up to 5 days after vaccination 1|The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.|||Percentage of Participants|||Number
2534359|NCT03239873|Secondary|Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 2 (Incidence > 0%)|The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.|Up to 42 days after vaccination 2|The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.|||Percentage of Participants|||Number
2534360|NCT03239873|Secondary|Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 1 (Incidence > 0%)|The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding.|Up to 42 days after vaccination 1|The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.|||Percentage of Participants|||Number
2534361|NCT03239873|Secondary|Percentage of Participants With Fever (≥102.2 °F Oral Equivalent)|The percentage of participants with fever ≥102.2 °F oral equivalent for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.|Up to 42 days after vaccination 1; Up to 42 days after vaccination 2|The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with temperature data at the time of assessment.|||Percentage of Participants|||Number
2534362|NCT03239873|Primary|Geometric Mean Titer of VZV Antibodies|The geometric mean titer (GMT) of VZV antibodies after vaccination 1 was assessed. Antibody titers were measured with gpELISA.|6 weeks (43 days) after vaccination 1|The analysis population included the number of participants with seronegative antibody titer (<1.25 gpELISA units/mL) at baseline and postvaccination serology.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2534363|NCT03239873|Primary|Percentage of Participants With Varicella Zoster Virus Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL|The varicella zoster virus (VZV) antibody response rate was defined as the percentage of participants with VZV antibody titer ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL among participants who were seronegative to VZV (titers <1.25 gpELISA units/mL) at baseline.|6 weeks (43 days) after vaccination 1|The analysis population included the number of participants with seronegative antibody titer (<1.25 gpELISA units/mL) at baseline and postvaccination serology.|||Percentage of Participants||95% Confidence Interval|Number
2534364|NCT03239522|Secondary|Change From Baseline in Body Temperature|Body temperature measurement was performed in participants at indicated time points. Baseline is defined as the pre-dose on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.|Baseline (Pre-dose on Day 1 in treatment period 1 and 2); 3 hours, 144 hours (Day 7) in treatment period 1; 3 hours, 144 hours (Day 7) and Day 8 in treatment period 2|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Celsius||Standard Deviation|Mean
2534434|NCT03238911|Secondary|Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35|"Safety~Change in vitamin 25-Hydroxyvitamin D (vitamin D 25) from baseline to days 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||ng/mL||Standard Deviation|Mean
2534365|NCT03239522|Secondary|Change From Baseline in Respiratory Rate|Respiratory rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the pre-dose on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.|Baseline (Pre-dose on Day 1 in treatment period 1 and 2); 3 hours, 144 hours (Day 7) in treatment period 1; 3 hours, 144 hours (Day 7) and Day 8 in treatment period 2|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Breaths per minute||Standard Deviation|Mean
2534366|NCT03239522|Secondary|Change From Baseline in Heart Rate|Heart rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the mean of the 3 pre-dose measurements (Avg Pre-dose) taken on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.|Baseline (average of Pre-dose on Day 1 in treatment period 1 and 2); 3 hours, 144 hours (Day 7) in treatment period 1; 3 hours, 144 hours (Day 7) and Day 8 in treatment period 2|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Beats per minute||Standard Deviation|Mean
2534367|NCT03239522|Secondary|Change From Baseline in Blood Pressure|Vital sign including systolic and diastolic blood pressure were measured in a semi-supine position after 5 minutes rest. Baseline is defined as the mean of the 3 pre-dose measurements (Average [Avg] Pre-dose) taken on Day 1 in each treatment period. Change from Baseline was defined as any visit value minus the Baseline value. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.|Baseline (average of Pre-dose on Day 1 in treatment period 1 and 2); 3 hours, 144 hours (Day 7) in treatment period 1; 3 hours, 144 hours (Day 7) and Day 8 in treatment period 2|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimeters of mercury||Standard Deviation|Mean
2534368|NCT03239522|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Full 12-lead ECGs were recorded with the participant in a supine position. The number of participants with abnormal ECG findings at indicated time points were presented. Data has been presented for participants with respect to the actual treatment received in respective treatment periods.|Pre-dose (on Day 1) and Day 8 in treatment period 2; 144 hours (Day 7) in treatment period 1|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2534369|NCT03239522|Secondary|Number of Participants With Abnormal Urinalysis Findings|Urine samples were collected at indicated time points for the analysis of urinalysis parameters including specific gravity and PH of urine, presence of glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase in urine.|Up to 43 days|Safety Population|||Participants|||Count of Participants
2534370|NCT03239522|Secondary|Number of Participants With Worst Case Hematology Results Relative to Normal Range|"Blood samples were collected from participants at indicated time points for the analysis of hematology parameters including Basophils, Eosinophils, Erythrocyte Mean Corpuscular Hemoglobin (MCH), Erythrocyte Mean Corpuscular Volume (MCV), Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets, Reticulocytes, and Reticulocytes/Erythrocytes. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment."|Up to 43 days|Safety Population|||Participants|||Count of Participants
2534371|NCT03239522|Secondary|Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range|"Blood samples were collected from participants at indicated time points for the analysis of clinical chemistry parameters including Alanine Aminotransferase (ALT), Alkaline phosphatase (Alk Phos), Aspartate Aminotransferase (AST), Bilirubin, Calcium, Creatinine, Direct Bilirubin, Glucose, Potassium, Protein, Sodium and Urea. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there was no change in their category. Participants whose lab value category was unchanged (example given [e.g.], High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment."|Up to 43 days|Safety Population|||Participants|||Count of Participants
2534372|NCT03239522|Secondary|Number of Participants With AEs at a Particular Severity|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Severity was categorized as mild, moderate and severe. The number of participants with AEs at any type of severity (mild, moderate and severe) has been presented.|Up to 43 days|Safety Population|||Participants|||Count of Participants
2534373|NCT03239522|Secondary|Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life- threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per Medical or scientific judgment. Safety Population comprised of all participants who take at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.|Up to 43 days|Safety Population|||Participants|||Count of Participants
2534468|NCT03238001|Secondary|Quadratic Weighted Kappa on Primary Endpoints|Quadratic weighted Cohen's kappa with 95% CI between DCTclock and MoCA, as well as between MMSE and MoCA.|Visit 1 (day 1)||||Quadratic Weighted Kappa||95% Confidence Interval|Number
2534374|NCT03239522|Secondary|Percent Radioactivity Recovered for Each Metabolite in Duodenal Bile Following a Single Dose of [14C]-GSK1278863 50 µg IV Infusion|The bile string was swallowed by participants prior to oral dose and was removed 3 hours after the oral dose (1 hour after the end of the IV infusion) in treatment period-1. Duodenal bile string extracts were pooled to create a single pool sample to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single dose of [14C]-GSK1278863 50 µg IV infusion. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220), M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102). Mean percent radioactivity recovered for each metabolite in bile following a single dose of [14C]-GSK1278863 50 µg IV infusion is presented.|3 hours post-oral dose in period 1|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.|||Percent radioactivity|||Number
2534375|NCT03239522|Secondary|Percent Radioactivity Recovered for Each Metabolite in Feces Following a Single Oral Dose of [14C]-GSK1278863 at 25 mg|Feces samples were collected in treatment period 2 to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single oral dose of [14C]-GSK1278863 at 25 mg. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220), M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102) and M14 combined. One pooled feces sample was prepared by samples collected from 0 to 120 hours post dose from all participants. Percent radioactivity recovered for each metabolite in feces following a single oral dose of [14C]-GSK1278863 at 25 mg is presented.|0-120 hours in period 2|Pharmacokinetic Population|||Percent radioactivity|||Number
2534376|NCT03239522|Secondary|Percent Radioactivity Recovered for Each Metabolite in Urine Following a Single Oral Dose of [14C]-GSK1278863 at 25 mg|Urine samples were collected in treatment period 2 to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single oral dose of [14C]-GSK1278863 at 25 mg. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220) and M33 combined, M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102) and M14 combined. One pooled urine sample was prepared by urine collected from 0 to 24 hours post dose from all participants. Percent radioactivity recovered for each metabolite in urine following a single oral dose of [14C]-GSK1278863 at 25 mg is presented.|0-24 hours in period 2|Pharmacokinetic Population|||Percent radioactivity|||Number
2534377|NCT03239522|Secondary|Percent Radioactivity Recovered for Each Metabolite in Plasma Following a Single Oral Dose of [14C]-GSK1278863 at 25 mg|Blood samples were collected in treatment period 2 to measure total radioactivity and to characterize the metabolite profiling of GSK1278863 following a single oral dose of [14C]-GSK1278863 at 25 mg. Potential metabolites were M3 (GSK2506104), M2 (GSK2391220) and M33 combined, M4 (GSK2487818), M6 (GSK2531398), M13 (GSK2531401), M5 (GSK2506102) and M14 combined. 2 pooled plasma samples were prepared. Aliquots of plasma samples collected between 0 to 8 hours post-dose from each participant were pooled in proportion to the time intervals. An equal amount of the individual pools from each participant was then pooled to create 1 plasma sample that was representative of the mean area under curve over the range of 0-8 hour. The second pool (10-12 hours pool) was obtained by mixing equal volume of the plasma samples at 10 and 12 hour across all participants. Percent radioactivity recovered for each metabolite in plasma following a single oral dose of [14C]-GSK1278863 at 25 mg is presented.|0-8 hours, 10-12 hours in period 2|Pharmacokinetic Population|||Percent radioactivity|||Number
2534378|NCT03239522|Secondary|Absolute Bioavailability of GSK1278863 Following Oral Dosing|Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose, computed as ratio of AUC(oral)/Dose(oral) with AUC(IV)/Dose(IV). Plasma samples were collected from participants at indicated time points. Absolute bioavailability from the oral tablet and IV doses administered in treatment period 1 was analyzed using AUC(0-inf) and AUC(0-t) pharmacokinetic parameters.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Ratio of dose normalized AUC||Geometric Coefficient of Variation|Geometric Mean
2534379|NCT03239522|Secondary|CL of GSK1278863 Metabolites in Plasma Following IV Dose Administration|Plasma samples were planned to be collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1|Pharmacokinetic Population. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.||||||
2534380|NCT03239522|Secondary|CL of GSK1278863 in Plasma Following IV Dose Administration|Plasma samples were collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.|||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
2534381|NCT03239522|Secondary|Vss of GSK1278863 Metabolites in Plasma Following IV Dose Administration|Plasma samples were planned to be collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1|Pharmacokinetic Population. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.||||||
2537976|NCT03118739|Other Pre-specified|Baseline Serum High-sensitivity C-reactive Protein||Baseline||||mg/dL||Standard Deviation|Mean
2534382|NCT03239522|Secondary|Vss of GSK1278863 in Plasma Following IV Dose Administration|Plasma samples were collected from participants at indicated time points, after administration of radiolabeled IV dose of GSK1278863 to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2534383|NCT03239522|Secondary|T1/2 of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses|Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.|||Hour||Geometric Coefficient of Variation|Geometric Mean
2534384|NCT03239522|Secondary|Tmax of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses|Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.|||Hour||Full Range|Median
2534385|NCT03239522|Secondary|Cmax of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses|Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population.Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534386|NCT03239522|Secondary|AUC(0-t) of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses|Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534387|NCT03239522|Secondary|AUC (0-Inf) of GSK1278863 Metabolites in Plasma Following Administration of IV and Both Oral Doses|Plasma samples were collected from participants at indicated time points, for metabolite profiling. GSK2391220, GSK2506104, GSK2487818, GSK2506102, GSK2531398 and GSK2531401 were metabolites of GSK1278863.Pharmacokinetic analysis was conducted using standard non-compartmental methods. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population. Data were not collected for GSK1278863 metabolites following IV dose as analysis of pharmacokinetic parameters of only parent compound following IV dose was of interest to calculate the bioavailability and not the metabolites.|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534388|NCT03239522|Secondary|T1/2 of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses|Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.|||Hour||Geometric Coefficient of Variation|Geometric Mean
2534389|NCT03239522|Secondary|Tmax of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses|Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population|||Hour||Full Range|Median
2534390|NCT03239522|Secondary|Cmax of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses|Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534391|NCT03239522|Secondary|AUC(0-t) of GSK1278863 in Plasma Following Administration of IV and Both Oral Doses|Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534392|NCT03239522|Secondary|AUC (0-Inf) of GSK1278863 in Plasma Following Administration IV and Both Oral Doses|Plasma samples were collected from participants at indicated time points, after administration of IV dose, both radiolabeled and non-radiolabeled oral doses of GSK1278863. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534393|NCT03239522|Primary|Percentage of the Total Radioactive Dose Excreted in Urine and Feces Determined as Total Excretion Over Time|Urine and fecal samples were collected at the indicated time points to determine the rate and extent of cumulative excretion of total radioactivity in urine and feces.|Pre-dose and then over 24 hour collection periods as follows: 0-24, 24‒48, 48-72, 72-96, 96-120, 120-144 and 144-168 hours post-dose in treatment period 2|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent dose excreted||Standard Deviation|Mean
2534394|NCT03239522|Primary|Percentage of the Total Radioactive Dose Excreted in Feces Over Time Following a Single, Oral Dose of [14C]-GSK1278863|Fecal samples were collected at the indicated time points to determine the rate and extent of excretion of total radioactivity in feces.|Pre-dose and then over 24 hour collection periods as follows: 0-24, 24‒48, 48-72, 72-96, 96-120, 120-144 and 144-168 hours post-dose in treatment period 2|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent dose excreted||Standard Deviation|Mean
2534395|NCT03239522|Primary|Percentage of the Total Radioactive Dose Excreted in Urine Over Time Following a Single, Oral Dose of [14C]-GSK1278863|Urine samples were collected at the indicated time points to determine the rate and extent of excretion of total radioactivity in urine. All participants were asked to void their bladders before study treatment administration.|Pre-dose and then over 24 hours collection periods as follows: 0-24, 24‒48, 48-72, 72-96, 96-120,120-144 and 144-168 hours post-dose in treatment period 2|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent dose excreted||Standard Deviation|Mean
2534396|NCT03239522|Primary|CL of Total Drug-related Material (Radioactivity) in Blood Following IV Dose of GSK1278863|Blood samples were planned to be collected from participants at indicated time points in treatment period 1 after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1|Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation).||||||
2534397|NCT03239522|Primary|Total Systemic Clearance (CL) of Total Drug-related Material (Radioactivity) in Plasma Following IV Dose of GSK1278863|Plasma samples were collected from participants at indicated time points in treatment period 1 after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2534398|NCT03239522|Primary|Vss of Total Drug-related Material (Radioactivity) in Blood Following IV Dose of GSK1278863|Blood samples were planned to be collected from participants at indicated time points in treatment period 1, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1|Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation).||||||
2537977|NCT03118739|Other Pre-specified|Baseline Serum Cystatin-C||Baseline||||mg/L||Standard Deviation|Mean
2537978|NCT03118739|Other Pre-specified|Baseline Serum Creatinine||Baseline||||mg/dL||Standard Deviation|Mean
2534399|NCT03239522|Primary|Volume of Distribution at Steady State (Vss) of Total Drug-related Material (Radioactivity) in Plasma Following IV Dose of GSK1278863|Plasma samples were collected from participants at indicated time points in treatment period 1, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2534400|NCT03239522|Primary|T1/2 of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863|Blood samples were planned to be collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error. Data were not analyzed for radiolabeled oral dose of GSK1278863 as there were not enough data points captured for a terminal slope required to calculate t1/2. The blood assay could not detect radiation levels at the time points blood was drawn to go into these calculations.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation). Data were not analyzed for radiolabeled oral dose GSK1278863 as there were not enough data points captured for a terminal slope required to calculate t1/2.||||||
2534401|NCT03239522|Primary|Apparent Terminal Phase Half-life (t1/2) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863|Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.|||Hour||Geometric Coefficient of Variation|Geometric Mean
2534402|NCT03239522|Primary|Tmax of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863|Blood samples were collected from participants at indicated time points after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation).|||Hour||Full Range|Median
2534403|NCT03239522|Primary|Time of Occurrence of Cmax (Tmax) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863|Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population|||Hour||Full Range|Median
2534404|NCT03239522|Primary|Cmax of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863|Blood samples were collected from participants at indicated time points after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation).|||Nanogram equivalent per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534405|NCT03239522|Primary|Maximum Observed Plasma Concentration (Cmax) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863|Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population|||Nanogram equivalent per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534414|NCT03239483|Primary|Measurement of Dapivirine Concentrations in Rectal Fluid|As assessed by pharmacokinetic rectal fluid sampling and analysis|Sample collected at approximately 1, 2, 24, 48 and 72 hours after first single dose, 24 hours after first dose during daily dosing, and 1,2, 24,48, and 72 hours after last dose.|enrolled participants on the Dapivirine arm who received at least one dose of product and had a sample collected at the specific time-point. 0 is an estimate for values below the limit of quantification (LLOQ = 0.001 ng/mg) since only numeric values are allowed. The value would be somewhere between the lower limit of quantification and 0.|||ng/mg||Inter-Quartile Range|Median
2537979|NCT03118739|Other Pre-specified|Baseline Serum Uric Acid (sUA)||Baseline||||mg/dL||Standard Deviation|Mean
2537980|NCT03118739|Other Pre-specified|Baseline UACR||Baseline||||mg/g||Standard Deviation|Mean
2534406|NCT03239522|Primary|AUC (0-t) of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863|Blood samples were collected from participants at indicated time points after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation).|||Hour*nanogram equivalent per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534407|NCT03239522|Primary|AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC [0-t]) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863|Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population|||Hour*nanogram equivalent per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534408|NCT03239522|Primary|AUC (0-Inf) of Total Drug-related Material (Radioactivity) in Blood Following Administration of GSK1278863|Blood samples were planned to be collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in blood. Data were not collected for blood total radioactivity concentration following administration of radiolabeled IV dose of GSK1278863 because of an error (deviation). The deviation is due to a processing error: labels for whole blood draws, and aliquots for shipment were not generated in error. Data were not analyzed for radiolabeled oral dose of GSK1278863 as there were not enough data points captured for a terminal slope required to calculate AUC (0-inf). The blood assay could not detect radiation levels at the time points blood was drawn to go into these calculations.|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population. Data were not collected for radiolabeled IV dose of GSK1278863 because of an error (deviation). Data were not analyzed for radiolabeled oral dose GSK1278863 as there were not enough data points captured for a terminal slope required to calculate AUC (0-inf).||||||
2534409|NCT03239522|Primary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-Inf]) of Total Drug-related Material (Radioactivity) in Plasma Following Administration of GSK1278863|Plasma samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of GSK1278863 in plasma. Pharmacokinetic analysis was conducted using standard non-compartmental methods. Pharmacokinetic Population comprised of all participants in the Safety Population who had at least 1 non-missing pharmacokinetic assessment (Non-quantifiable [NQ] values were considered as non-missing values).|Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 1; Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose in treatment period 2|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.|||Hour*nanogram equivalent per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534410|NCT03239483|Secondary|Acceptability: Comfort|The number of participants who responded on a questionnaire that the study product was comfortable or very comfortable.|after completing the study (study day 40)||||Participants|||Count of Participants
2534411|NCT03239483|Secondary|Acceptability: Ease of Use|The number of participants who responded by questionnaire that the study product was easy or very easy to use.|after completing the study (study day 40)|All enrolled participants who completed the exit behavioral questionnaire.|||Participants|||Count of Participants
2534412|NCT03239483|Primary|Terminal Half-life of Dapivirine Concentrations in Plasma|The terminal half-life of dapivirine in plasma samples was estimated by fitting a linear regression on the log-transformed concentrations from the 24, 48 and 72 hour time-points after the single and multiple doses.Each regression model includes an adjustment for the difference in concentration after multiple dosing. For each participant, Beta was calculated as the negative of the slope of their repression and half-life was log(2)/Beta. Due to the large number of concentrations below the limit of quantification after the single dose, the estimateion of Beta and half-life relied only on concentration after the multiple dosing for most of the participants.|From samples collected 24 hours after first dose to 72 hours after last daily dose|enrolled participants on the Dapivirine gel arm who received at least one dose of study product. One participant with a negative estimate for the elimination rate due to an increasing trend in their concentration after multiple dosing and one participant with no values above the limit of quantification were excluded.|||hours||Inter-Quartile Range|Median
2534413|NCT03239483|Primary|Measurement of Dapivirine Concentrations in Rectal Mucosal Tissue Homogenates|As assessed by pharmacokinetic rectal mucosal tissue homogenates sampling and analysis|Sample collected at approximately 1, 2, 24, 48 and 72 hours after first single dose and 1,2, 24,48, and 72 hours after last dose.|enrolled participants on the Dapivirine gel arm who received at least one dose of study product and had a sample collected at the specific time-point. 0 is an estimate for values below the limit of quantification (LLOQ = 0.001 ng/mg) since only numeric values are allowed. The value would be somewhere between the LLOQ and 0.|||ng/mg||Inter-Quartile Range|Median
2534432|NCT03238911|Secondary|Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35|"Safety~Change in 24,25-Dihydroxyvitamin D (vitamin D 24.25) from baseline to days 1, 7, 8, 14, 21, and 35"|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||ng/mL||Standard Deviation|Mean
2537981|NCT03118739|Other Pre-specified|Baseline eGFR||Baseline||||mL/min/1.73m2||Standard Deviation|Mean
2534415|NCT03239483|Primary|Measurement of Dapivirine Concentrations in Plasma|As assessed by pharmacokinetic sampling and analysis|Sample collected at approximately 1, 2, 24, 48 and 72 hours after first single dose, 24 hours after first dose during daily dosing, before last dose and 1,2, 24,48, and 72 hours after last dose.|enrolled participants on the Dapivirine arm who received at least one dose of study product and had a sample collected at the specific time-point. 0 is an estimate for values below the limit of quantification (LLOQ = 20 pg/mL) since only numeric values are allowed. The value would be somewhere between the LLOQ and 0.|||pg/mL||Inter-Quartile Range|Median
2534416|NCT03239483|Primary|Frequency of Grade 2 or Higher Adverse Events (AEs)|As defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addenda 1, 2 and 3 (Female Genital [Dated November 2007], Male Genital [Dated November 2007] and Rectal [Clarification Dated May 2012] Grading Tables for Use in Microbicide Studies)|Measured after the participant has started study product until the participant's study termination at approximately Day 40|enrolled participants receiving at least one dose of study product|||Participants|||Count of Participants
2534417|NCT03239106|Other Pre-specified|Skin RNA-seq (Exploratory Endpoint)|Skin biopsies at baseline and Week 16|Baseline and Week 16||2020-05-31|05/2020||||
2534418|NCT03239106|Secondary|DLQI at Screening, Baseline, and Weeks 2,4,8,12,16 and 18|Participants will complete a 10 question Dermatology Life Quality Index questionnaire at Screening, Baseline, and Weeks 2,4,8,12,16,18.|Screening through Week 18 (follow up visit)|||||||
2534419|NCT03239106|Secondary|NRS at Screening, Baseline and Weeks 2,4,8,12,16,and 18|Participants' itch will be measured utilizing the Numeric Rating Scale for itch|Screening through Week 18 (follow up visit)|||||||
2534420|NCT03239106|Secondary|Absolute DLQI at Week 16|"Participants will complete a 10 question Dermatology Quality of Life survey at baseline through Week 16~The DLQI is a numerical scale that scores multiple parameters of skin symptoms on a scale from 0 to 30. 0-1 = no effect at all on a patient's life (most favorable clinical outcome and minimum score), 1-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11-20 = very large effect on patient's life, 21-30 = extremely large effect on patient's life (worse clinical outcome and maximum score)."|Week 16|Patients who met inclusion criteria with a diagnosis of chronic pruritus of unknown origin|||Score on a scale||Inter-Quartile Range|Median
2534421|NCT03239106|Primary|Absolute NRS Itch Score at Week 16 (End of Treatment)|"Participants will complete a Numeric Rating Scale for itch (0 representing no itching through 10 representing worst itch imaginable) will be recalled from prior 24 hours and the prior week.~0 is the best score (minimum) and 10 is the worst score (maximum) in terms of clinical outcome. This is an ordinal scale that runs from 0 to 10."|Week 16|All patients met criteria for chronic pruritus of unknown origin.|||Units on a scale||Inter-Quartile Range|Median
2534422|NCT03238924|Secondary|Depression Symptom Severity|Beck Depression Inventory-II. The BDI-II is a self-report measure where each item is rated on a 0-3 scale and summed to obtain a total score. Greater scores are reflective of greater symptom severity.|Change from Baseline to end of treatment (10 weeks)|Data belonging to participants who completed the trial were examined.|||scores on a scale||Standard Deviation|Mean
2534423|NCT03238924|Secondary|PTSD Symptom Severity|PTSD Checklist (PCL). The PCL is a self-report measure which uses a 5-point scale to assess the frequency and severity of PTSD symptoms. Item responses are summed to obtain a total score ranging from 17-85 with greater scores reflective of greater symptom severity.|Change from Baseline to end of treatment (10 weeks)|Data belonging to participants who completed the trial were examined.|||scores on a scale||Standard Deviation|Mean
2534424|NCT03238924|Primary|PTSD Symptom Severity|Clinician-Administered PTSD Scale (CAPS-5). CAPS-5 scores range from 0-120. Items are summed to obtain a total score with higher scores reflective of greater symptom severity.|Change from Baseline to end of treatment (10 weeks)|Data belonging to participants who completed the trial were examined.|||scores on a scale||Standard Deviation|Mean
2534425|NCT03238911|Post-Hoc|Incidence of S-phosphate Level ≤1.0 mg/dL at Any Time From Baseline to Day 35|"Safety~Incidence of hypophosphatemia (defined as s-phosphate level ≤1 mg/dL) at any time from baseline up to day 35."|Baseline to day 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||Participants|||Count of Participants
2534426|NCT03238911|Secondary|Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35|"Efficacy~Change in Transferrin Saturation (TSAT) from baseline to days 1, 7, 8, 14, 21, and 35.~TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron."|Baseline, days 1, 7, 8, 14, 21, and 35|Intention-To-Treat (ITT) analysis set: included all randomised subjects.|||percentage of saturation||Standard Deviation|Mean
2534427|NCT03238911|Secondary|Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35|"Efficacy~Change in s-ferritin from baseline to days 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Intention-To-Treat (ITT) analysis set: included all randomised subjects.|||ng/mL||Standard Deviation|Mean
2534428|NCT03238911|Secondary|Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35|"Efficacy~Change in hemoglobin (Hb) per gram iron from baseline to days 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Intention-To-Treat (ITT) analysis set: included all randomised subjects.|||g/dL per g of iron||Standard Deviation|Mean
2534429|NCT03238911|Secondary|Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions|"Safety~For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated."|Baseline to day 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||Participants|||Count of Participants
2534430|NCT03238911|Secondary|Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35|"Safety~Change in ionized calcium from baseline to days 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product|||mg/dL||Standard Deviation|Mean
2534431|NCT03238911|Secondary|Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35|"Safety~Change in intact Parathyroid hormone (PTH) from baseline to days 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||pg/mL||Standard Deviation|Mean
2534435|NCT03238911|Secondary|Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35|"Safety~Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) from baseline to days 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||RU/mL||Standard Deviation|Mean
2534436|NCT03238911|Secondary|Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35|"Safety~Change in concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) from baseline to day 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||pg/mL||Standard Deviation|Mean
2534437|NCT03238911|Secondary|Change From Baseline in Fractional Phosphate Urinary Excretion|"Safety~Change in absolute fractional phosphate urinary excretion from baseline to days 1, 7, 8, 14, 21, and 35.~Fractional excretion of phosphate (FEPi) is calculated as ([phosphate in urine X creatinine in serum]/[phosphate in serum X creatinine in urine]) X 100, and the unit is %."|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||percentage excreted||Standard Deviation|Mean
2534438|NCT03238911|Secondary|Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35|"Safety~Relative [%] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||Percentage change from baseline||Standard Deviation|Mean
2534439|NCT03238911|Secondary|Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35|"Safety~Absolute [∆] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||mg/dL||Standard Deviation|Mean
2534440|NCT03238911|Secondary|Proportion of Subjects With Hypophosphatemia on Day 35 ( S-phosphate Level <2.0 mg/dL)|"Safety~Evaluate the proportion of subjects with hypophosphatemia (s-phosphate level <2.0 mg/dL) on day 35."|Baseline to day 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||Participants|||Count of Participants
2534441|NCT03238911|Secondary|Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL)|"Safety~Time with hypophosphatemia (i.e. time with s-phosphate level < 2.0 mg/dL) from baseline up to day 35.~The time with hypophosphatemia was calculated as the actual number of days from the first day where s-phosphate was <2 mg/dL until the first day when s-phosphate was ≥2 mg/dL. If the subject did not reach s-phosphate ≥2 mg/dL, the subject was regarded as censored on day 35."|Baseline to day 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||days||95% Confidence Interval|Median
2534442|NCT03238911|Primary|Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL)|"Safety~The incidence of hypophosphatemia (defined as s-phosphate <2 mg/dL) at any time from baseline up to day 35."|Baseline to day 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||Participants|||Count of Participants
2534443|NCT03238781|Secondary|Percentage of Participants With Respiratory Rates in Categories by Visit|Participant was expected to be in a supine position (or the most recumbent position possible) in a rested and calm state for at least 5 minutes before vital sign assessments were conducted. Respiratory rate (RR) is reported in breaths/minute.|Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28|Safety analysis population of participants with data at that visit.|||percentage of participants|||Number
2534444|NCT03238781|Secondary|Percentage of Participants With Temperature in Categories by Visit|Participant was expected to be in a supine position (or the most recumbent position possible) in a rested and calm state for at least 5 minutes before vital sign assessments were conducted. Temperature units are reported in degrees Celsius (C).|Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28|Safety analysis population of participants with data at that visit.|||percentage of participants|||Number
2534445|NCT03238781|Secondary|Percentage of Participants With Pulse Rate in Categories by Visit|Participant was expected to be in a supine position (or the most recumbent position possible) in a rested and calm state for at least 5 minutes before pulse assessments were conducted. Pulse rate units are beats per minute (BPM)|Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28|Safety analysis population of participants with data at that visit.|||percentage of participants|||Number
2534446|NCT03238781|Secondary|Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit|Participant was expected to be in a supine position (or the most recumbent position possible) in a rested and calm state for at least 5 minutes before blood pressure assessments were conducted. Blood pressure units are millimeters of mercury (mmHg).|Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28|Safety analysis population of participants with data at that visit.|||percentage of participants|||Number
2534447|NCT03238781|Secondary|Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit|Participant was expected to be in a supine position (or the most recumbent position possible) in a rested and calm state for at least 5 minutes before blood pressure assessments were conducted. Blood pressure units are millimeters of mercury (mmHg).|Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28|Safety analysis population of participants with data at that visit.|||percentage of participants|||Number
2534448|NCT03238781|Secondary|Percentage of Participants With Total Bilirubin Test Abnormalities > 2 Times the Upper Limit of Normal (ULN) at Baseline and On Study|Percentage of participants with total bilirubin results that were greater than 2 * ULN are reported.|Baseline: Day 1 On study: Weeks 4, 6, 12, 20, 28|Safety analysis set|||percentage of participants|||Number
2534449|NCT03238781|Secondary|Percentage of Participants With Aminotransferase Test Abnormalities > 3 Times the Upper Limit of Normal (ULN) at Baseline and On Study|Aminotransferase tests included alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Percentage of participants with results that were greater than 3 * ULN for either test are reported.|Baseline: Day 1 On study: Weeks 4, 6, 12, 20, 28|Safety analysis set|||percentage of participants|||Number
2534469|NCT03238001|Primary|Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE)|The primary analysis will assess agreement between DCTclock and the Montreal Cognitive Assessment (MoCA) and compare it to the agreement between the MMSE and MoCA at visit 1.|Visit 1 (day 1)|The Evaluable Population includes all qualified participants undergoing cognitive testing with DCTclock, MMSE, and MoCA who completed visit 1.|||Difference in Quadratic Weighted Kappas||90% Confidence Interval|Number
2534450|NCT03238781|Secondary|Percentage of Participants Who Met Hy's Law Criteria at Baseline and On Study|"Hy's law predicts potential for drug-related hepatotoxicity. Hy's Law cases have three components:~The drug causes hepatocellular injury, generally defined as an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) by 3-fold or greater above the upper limit of normal (ULN).~Among participants showing such aminotransferase elevations, they also have elevation of their serum total bilirubin of greater than 2 times the ULN, without findings of cholestasis (defined as serum alkaline phosphatase activity less than 2 times the upper limit of normal).~No other reason can be found to explain the combination of increased aminotransferase and serum total bilirubin, such as viral hepatitis, alcohol abuse, ischemia, preexisting liver disease, or another drug capable of causing the observed injury."|Baseline: Day 1 On study: Weeks 4, 6, 12, 20, 28|Safety analysis set|||percentage of participants|||Number
2534451|NCT03238781|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|"Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4, where:~Grade 1 = Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 = Life-threatening consequences; urgent intervention indicated Grade 5 = Death related to AE."|Day 1 up to Week 30 (12 weeks of double-blind treatment plus 18 weeks follow-up after last dose of investigational product)|The Safety Analysis Set (SAS) consists of all enrolled participants who received >= 1 dose of investigational product (IP). If a participant received the incorrect dose during the entire double-blind treatment period (DBTP), the participant was analyzed according to treatment received.|||Participants|||Count of Participants
2534452|NCT03238781|Secondary|Change From Baseline in Mean Impact on Everyday Activity Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) Over the Last 4 Weeks of the 12-Week Double-Blind Treatment Period|"Participants complete the MPFID every day during baseline (Days -28 to Day -1) and the 12-week Double Blind Treatment Period. The MPFID has 2 domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and 1 stand-alone global question that provides an assessment of the overall impact of migraine on participants' everyday activities. The recall period for each item is the past 24 hours.~The Impact on Everyday Activities Domain Score is reported here. A participant's response to the Impact on Everyday Activities 7 items is measured using a 5-point scale, with difficulty measurements ranging from 1 to 5. The sum was rescaled to a 0 to 100 scale, with 0=no difficulty and 100=unable to do (maximum burden). Negative change from baseline values indicate improvement in migraine impact."|Baseline Day -28 to Day -1; Weeks 9-12|"Efficacy Analysis set consisting of participants who were randomized, received >=1 dose of investigational product, and have >=1 postbaseline monthly eDiary measurement. Participants were analyzed according to their randomized treatment group, regardless of treatment received.~Participants with both baseline and week 9-12 values are included."|||units on a scale||Standard Error|Least Squares Mean
2534453|NCT03238781|Secondary|Change From Baseline in Mean Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) Over the Last 4 Weeks of the 12-Week Double-Blind Treatment Period|"Participants complete the MPFID every day during baseline (Days -28 to Day -1) and the 12-week Double Blind Treatment Period. The MPFID has 2 domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and 1 stand-alone global question that provides an assessment of the overall impact of migraine on participants' everyday activities. The recall period for each item is the past 24 hours.~The Physical Impairment Domain Score is reported here. A participant's response to the difficulty of the 5 physical impairment items is measured using a 5-point scale, with difficulty measurements ranging from 1 to 5. The sum was rescaled to a 0 to 100 scale, with 0=no difficulty and 100=unable to do (maximum burden). Negative change from baseline values indicate improvement in migraine impact."|Baseline Day -28 to Day -1; Weeks 9-12|"Efficacy Analysis set consisting of participants who were randomized, received >=1 dose of investigational product, and have >=1 postbaseline monthly eDiary measurement. Participants were analyzed according to their randomized treatment group, regardless of treatment received.~Participants with both baseline and week 9-12 values are included."|||units on a scale||Standard Error|Least Squares Mean
2534454|NCT03238781|Secondary|Change From Baseline Period in Monthly Acute Migraine-Specific Medication Days in the Last 4 Weeks of the 12-Week Double-Blind Treatment Period|"Number of days on which acute headache medications (triptans and ergotamine-derivatives, alone or in combination) are used as recorded in eDiary. Monthly acute headache medication treatment days at baseline are the number of acute headache medication treatment days in the baseline period. Days without eDiary data are handled by proration.~Negative change from baseline values indicate improvement (i.e. fewer days requiring acute migraine-specific medications after treatment as compared to baseline)."|Baseline Day -28 to Day -1; Weeks 9-12|"Efficacy Analysis set consisting of participants who were randomized, received >=1 dose of investigational product, and have >=1 postbaseline monthly eDiary measurement. Participants were analyzed according to their randomized treatment group, regardless of treatment received.~Participants with both baseline and week 9-12 values are included."|||days||Standard Error|Least Squares Mean
2534455|NCT03238781|Secondary|Percentage of Participants Who Responded, Defined as At Least a 50% Reduction From the Baseline Period in Monthly Migraine Days in the Last 4 Weeks of the 12-Week Double-Blind Treatment Period|Responders are participants who had at least a 50% reduction from baseline in monthly migraine days during the last 4 weeks of treatment in the 12-week double blind period.|Baseline Day -28 to Day -1; Weeks 9-12|"Efficacy Analysis set consisting of participants who were randomized, received >=1 dose of investigational product, and have >=1 postbaseline monthly eDiary measurement. Participants were analyzed according to their randomized treatment group, regardless of treatment received.~Participants with both baseline and week 9-12 values are included."|||percentage of participants|||Number
2534470|NCT03237871|Primary|Mean Number of Hours From Sending a Survey to Participants to Receiving Their Response in Week 1|Mean number of hours from sending a survey to enrolled participants to receiving their response in Week 1.|Week 1|Mean number of participants enrolled in the study who responded to the survey in week 1|||Mean number of hours||Standard Deviation|Mean
2538040|NCT03117140|Primary|Duration of Analgesia|Patients are called 1-3 days post-operatively to assess when the analgesia of their nerve block wore off|1-3 days post-operative||||minutes||Inter-Quartile Range|Median
2534456|NCT03238781|Primary|Change From Baseline in Monthly Migraine Days to the Last 4 Weeks of the 12 Week Double-Blind Treatment Period|"A migraine day is any calendar day from the eDiary in which the participant experienced a migraine headache. A migraine headache is a headache with or without aura, lasting for >= 4 hours, and meeting >=1 of the criteria:~>= 2 pain features (unilateral, throbbing, moderate to severe, exacerbated with exercise/physical activity)~>= 1 symptoms (nausea and/or vomiting, photophobia and phonophobia) If the participant took a migraine-specific medication during aura or to treat headache, it was counted as a migraine day.~Days without eDiary data in each monthly interval are handled by proration.~Negative change from baseline values indicated improvement (i.e. fewer migraine days after treatment as compared to baseline)."|Baseline Day -28 to Day -1; Weeks 9-12|"Efficacy Analysis set consisting of participants who were randomized, received >=1 dose of investigational product, and have >=1 postbaseline monthly eDiary measurement. Participants were analyzed according to their randomized treatment group, regardless of treatment received.~Participants with both baseline and week 9-12 values are included."|||days||Standard Error|Least Squares Mean
2534457|NCT03238352|Secondary|Change From Baseline in Tactile Threshold|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10 grams (g) and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Week 8|The ITT (N=85) population included all participants who were randomized received at least one dose of investigational product and had at least one post-baseline efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||Grams||Standard Deviation|Mean
2534458|NCT03238352|Primary|Change From Baseline in Schiff Sensitivity Score|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant did not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requested discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score will be indicative of an improvement in sensitivity.|Week 8|The Intent-to-Treat (ITT) (N=85) population comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||Score on Scale||Standard Deviation|Mean
2534459|NCT03238001|Other Pre-specified|Incidence of Serious Device-related Adverse Events [Safety]|Incidence of serious device-related adverse events.|Visit 1 and visit 2, occuring 1-4 weeks apart|All qualified participants who completed at least one DCTclock test.|||Participants|||Count of Participants
2534460|NCT03238001|Other Pre-specified|Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments|The goal of this analysis is to assess the construct validity of DCTclock. Specifically, the goal is to compare scores from the administration of DCTclock to the visit 1 administration of a battery of neuropsychological tests, to characterize the psychometric properties of DCTclock, and to compare those properties to the properties of MMSE.|Visit 1 (day 1)|Includes all qualified participants who completed testing at visit 1 and had evaluable data for each test analyzed. Roughly half of the population was administered the full neuropsychological battery. The remainder completed a partial battery (see protocol for details).|||Correlation Coefficient||95% Confidence Interval|Number
2534461|NCT03238001|Secondary|Correlation Coefficients on Secondary Endpoints (Test-retest Reliability)|Pearson and Spearman correlation coefficients were calculated between visit 1 and visit 2 for DCTclock and MMSE, along with 95% CI.|Visit 1 and visit 2, occurring 1-4 weeks apart||||Correlation Coefficients||95% Confidence Interval|Number
2534462|NCT03238001|Secondary|Regression Coefficients on Secondary Endpoints (Test-retest Reliability)|Deming, linear, and rank-linear correlation coefficients (intercept, slope) were calculated for visit 1 regressed on visit 2 for both DCTclock and MMSE.|Visit 1 and visit 2, occurring 1-4 weeks apart||||Regression Coefficients||95% Confidence Interval|Number
2534463|NCT03238001|Secondary|Percent Agreement on Secondary Endpoints (Test-retest Reliability)|"Positive percent agreement version A (treating the Indeterminate group as Unimpaired) and version B (removing the Indeterminate group from the analysis), negative percent agreement version A and version B, indeterminate percent agreement, and unimpaired percent agreement."|Visit 1 and visit 2, occurring 1-4 weeks apart|"Version A treats the Indeterminate group as Unimpaired, while version B removes the Indeterminate group from the analysis. Thus, the analysis population for version B is smaller than the overall analysis population."|||Percent Agreement||95% Confidence Interval|Number
2534464|NCT03238001|Secondary|Quadratic Weighted Kappa on Secondary Endpoints (Test-Retest Reliability)|Quadratic weighted Cohen's Kappa statistics were calculated for both DCTclock and MMSE test-retest data (visit 1 vs visit 2).|Visit 1 and visit 2, occurring 1-4 weeks apart||||Quadratic Weighted Cohen's Kappa||95% Confidence Interval|Number
2534465|NCT03238001|Secondary|Correlation Coefficients on Primary Endpoints|Pearson and Spearman correlation coefficients between DCTclock and MoCA as well as between MMSE and MoCA.|Visit 1 (day 1)||||Correlation Coefficients||95% Confidence Interval|Number
2534466|NCT03238001|Secondary|Regression Coefficients on Primary Endpoints|Linear and rank-linear regression coefficients (slope, intercept) and 95% CI for DCTclock regressed on MoCA as well as for the MMSE regressed on MoCA.|Visit 1 (day 1)||||Regression Coefficients||95% Confidence Interval|Number
2534467|NCT03238001|Secondary|Percent Agreement on Primary Endpoints|"Positive percent agreement, version A (treating the Indeterminate group as Unimpaired) and version B (removing the Indeterminate group from the analysis), and negative percent agreement version A and version B. These were calculated for the DCTclock/MoCA classification table as well as the MMSE/MoCA classification table. 95% CI were also calculated and compared between the two classification tables' calculations."|Visit 1 (day 1)|"Version A treats the Indeterminate group as Unimpaired, while version B removes the Indeterminate group from the analysis. Thus, the analysis population for version B is smaller than the overall analysis population."|||Percent Agreement||95% Confidence Interval|Number
2534472|NCT03237871|Primary|Number of Participants Who Respond to the Survey in Week 1|Number of enrolled participants who respond to the survey in Week 1. Measure type 'number' was used for small sample size and as described in the original registration protocol.|Week 1|Number of participants enrolled in the study|||Participants|||Count of Participants
2534473|NCT03237156|Secondary|Cmax,ss: Maximum Observed Serum Concentration During Dosing Interval at Steady State for Serum Prolactin on Day 7 of Multiple Dose Period|Cmax,ss is the peak serum concentration of serum prolactin during dosing interval at steady state.|Day 7 pre-dose and 1, 2, 4, 6, and 24 hours post-dose|The PD analysis set consisted of participants who received at least 1 dose of study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PD.|||ng/mL||Standard Deviation|Geometric Mean
2534474|NCT03237156|Secondary|AUC(t,ss): Area Under the Serum Concentration-time Curve From Time 0 During Dosing Interval at Steady State for Serum Prolactin on Day 7 of Multiple Dose Period|AUC(t,ss) defined as area under the serum concentration-time curve from Time 0 during dosing interval at steady state for serum prolactin was calculated.|Day 7 pre-dose and 1, 2, 4, 6, and 24 hours post-dose|The PD analysis set consisted of participants who received at least 1 dose of study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PD.|||h*ng/mL||Standard Deviation|Geometric Mean
2534475|NCT03237156|Secondary|AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Serum Prolactin on Day 1 of Single Dose Period|AUClast defined as area under the serum concentration-time curve from Time 0 to the Time of the last quantifiable concentration for serum prolactin was calculated.|Day 1 pre-dose and 1, 2, 4, 6, and 24 hours post-dose|The PD analysis set consisted of participants who received at least 1 dose of study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PD.|||h*ng/mL||Standard Deviation|Geometric Mean
2534476|NCT03237156|Secondary|Cmax: Maximum Observed Serum Concentration for Serum Prolactin on Day 1 of Single Dose Period|Cmax is the peak serum concentration of serum prolactin.|Day 1 pre-dose and 1, 2, 4, 6, and 24 hours post-dose|The PD analysis set consisted of participants who received at least 1 dose of study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PD.|||ng/mL||Standard Deviation|Geometric Mean
2534477|NCT03237156|Secondary|AUCtau: Area Under the Serum Concentration-time Curve During a Dosing Interval for Serum Prolactin on Day 1 of Single Dose Period|AUCtau defined as area under the serum concentration-time curve during a dosing interval for serum prolactin was calculated.|Day 1 pre-dose and 1, 2, 4, 6, and 24 hours post-dose|The pharmacodynamics (PD) analysis set consisted of participants who received at least 1 dose of study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PD.|||h*ng/mL||Standard Deviation|Geometric Mean
2534478|NCT03237156|Secondary|CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period|Renal clearance is a measure of apparent clearance of TAK-906 and its metabolite M23 from the urine.|Day 7 pre-dose and 0-6 and 6-12 hours post-dose|The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.|||L/h||Standard Deviation|Mean
2534479|NCT03237156|Secondary|Fetau: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period|Fetau was calculated as percentage of administered dose of drug excreted in urine from Time 0 to Time tau over the dosing interval for TAK-906 and its metabolite M23.|Day 7 pre-dose and 0-6 and 6-12 hours post-dose|The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.|||percentage of drug||Standard Deviation|Mean
2534480|NCT03237156|Secondary|Aetau: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period|Aetau is the amount of TAK-906 and its metabolite M23 excreted in urine during a dosing Interval.|Day 7 pre-dose and 0-6 and 6-12 hours post-dose|The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.|||mcg||Standard Deviation|Mean
2534481|NCT03237156|Secondary|t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period|t1/2z is time for the plasma concentration of TAK-906 and its metabolite M23 to decrease by half.|Day 7 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose|The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.|||hour||Standard Deviation|Mean
2534482|NCT03237156|Secondary|Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period|Tmax,ss is defined as time to reach the peak plasma concentration at steady state for TAK-906 and its metabolite M23.|Day 7 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose|The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.|||hours||Full Range|Median
2534483|NCT03237156|Secondary|Cmax,ss: Maximum Observed Plasma Concentration During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period|Cmax, ss is the peak plasma concentration of TAK-906 and its metabolite M23 during dosing interval at steady state.|Day 7 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose|The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.|||ng/mL||Standard Deviation|Geometric Mean
2534510|NCT03237065|Secondary|Change From Baseline in Fractional Phosphate Urinary Excretion|"Safety~Change in absolute fractional phosphate urinary excretion from baseline to days 1, 7, 8, 14, 21, and 35.~Fractional excretion of phosphate (FEPi) is calculated as ([phosphate in urine X creatinine in serum]/[phosphate in serum X creatinine in urine]) X 100, and the unit is %."|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||percentage excreted||Standard Deviation|Mean
2534484|NCT03237156|Secondary|AUC(τ,ss): Area Under the Plasma Concentration-time Curve From Time 0 During Dosing Interval at Steady State for TAK-906 and Its Metabolite M23 on Day 7 of Multiple Dose Period|AUC(τ,ss) is a measure of total plasma exposure to TAK-906 and its metabolite M23 from Time 0 during dosing interval at steady state.|Day 7 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose|The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.|||h*ng/mL||Standard Deviation|Geometric Mean
2534485|NCT03237156|Secondary|CLR: Renal Clearance for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period|Renal clearance is a measure of apparent clearance of TAK-906 and its metabolite M23 from the urine.|Day 1 pre-dose and 0-6, 6-12, and 12-24 hours post-dose|The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.|||liter per hour (L/h)||Standard Deviation|Mean
2534486|NCT03237156|Secondary|Fe24: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to 24 Hours for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose|Fe24 was calculated as percentage of administered dose of drug excreted in urine from Time 0 to 24 Hours for TAK-906 and its metabolite M23.|Time Frame Day 1 pre-dose and 0-6, 6-12, and 12-24 hours post-dose|The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.|||percentage of drug||Standard Deviation|Mean
2534487|NCT03237156|Secondary|Ae(0-24): Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period|Ae(0-24) is the amount of TAK-906 and its metabolite M23 excreted in urine from Time 0 to 24 Hours postdose.|Day 1 pre-dose and 0-6, 6-12, and 12-24 hours post-dose|The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.|||microgram (mcg)||Standard Deviation|Mean
2534488|NCT03237156|Secondary|t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period|t1/2z is time for the plasma concentration of TAK-906 and its metabolite M23 to decrease by half.|Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose|The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.|||hours||Standard Deviation|Mean
2534489|NCT03237156|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period|Tmax is time to reach the peak plasma concentration of TAK-906 and its metabolite M23.|Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose|The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.|||hours||Full Range|Median
2534490|NCT03237156|Secondary|AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period|AUCtau is a measure of total plasma exposure to TAK-906 and its Metabolite M23 from Time 0 to Time tau over the dosing interval.|Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose|The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.|||h*ng/mL||Standard Deviation|Geometric Mean
2534491|NCT03237156|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period|Cmax is the peak plasma concentration of TAK-906 and its metabolite M23.|Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose|The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2534492|NCT03237156|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period|AUC∞ is a measure of total plasma exposure to TAK-906 and its Metabolite M23 from Time 0 extrapolated to infinity, calculated using the observed value of the last quantifiable concentration.|Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose|The PK analysis set consisted of participants who received at least 1 dose of the study drug, completed the minimum protocol-specified procedures with no significant protocol deviations, and who were evaluable for the PK.|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Geometric Mean
2534493|NCT03237156|Primary|Number of Participants With TEAEs Related to Physical Examinations|An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment or study participation. A treatment-emergent adverse events (TEAE) is defined as an AE whose date of onset occurs on or after the start of study drug.|Baseline up to Day 14|The safety analysis set included all participants who received at least 1 dose of the study drug.|||Participants|||Count of Participants
2534494|NCT03237156|Primary|Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG)|Reported data were numbers of participants who met markedly abnormal criteria of 12-lead ECG. A standard 12-lead ECG was performed. The data collected was classified as markedly abnormal values if it met the following criteria: heart rate <50 bpm or >120 bpm, QT interval less than or equal to (<=) 50 msec or greater than or equal to (>=) 460 msec, QTcF interval <=50 msec or either of the following conditions was met: observed value >=500 msec, change from Day 1 Predose >= 30 msec and observed value >=450 msec.|Baseline up to Day 8|The safety analysis set included all participants who received at least 1 dose of the study drug.|||Participants|||Count of Participants
2534511|NCT03237065|Secondary|Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35|"Safety~Relative [%] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||Percentage change from baseline||Standard Deviation|Mean
2534495|NCT03237156|Primary|Number of Participants With Markedly Abnormal Values of Clinical Laboratory Test Results|Reported data were numbers of participants who met markedly abnormal criteria of clinical laboratory test results. Clinical laboratory test results collected were classified as markedly abnormal values if they met the following criteria: red blood cells <0.8×lower limit of normal (LLN) or >1.2×upper limit of normal (ULN), platelets <75×10^3/μL or >600×10^3/μL, white blood cells <0.5×LLN or >1.5×ULN, protein (total) <0.8×LLN or >1.2×ULN, albumin <2.5 g/dL, blood urea nitrogen >30 mg/dL, uric acid >13.0 mg/dL, creatinine >2.0 mg/dL, total cholesterol >300 mg/dL, triglycerides >2.5×ULN, bilirubin (total) >2.0 mg/dL, Sodium <130 mEq/L or >150 mEq/L, Potassium <3.0 mEq/L or >6.0 mEq/L, Chloride <75 mEq/L or >126 mEq/L, Calcium <7.0 mg/dL or >11.5 mg/dL, Phosphorus <1.6 mg/dL or >6.2 mg/dL, alkaline phosphatase >3×ULN, aspartate aminotransferase >3×ULN, alanine aminotransferase >3×ULN, gamma-glutamyl transferase >3×ULN, glucose <50 mg/dL or >350 mg/dL, Magnesium <1.2 mg/dL or >3.0 mg/dL.|Baseline up to Day 14|The safety analysis set included all participants who received at least 1 dose of the study drug.|||Participants|||Count of Participants
2534496|NCT03237156|Primary|Number of Participants With Markedly Abnormal Values of Vital Signs|Reported data were numbers of participants who met markedly abnormal criteria of vital signs. Vital signs included body temperature, respiratory rate, blood pressure, and pulse. Vital signs collected were classified as markedly abnormal values if they met the following criteria: systolic blood pressure less than (<) 85 millimeter of mercury (mmHg) or greater than (>) 180 mmHg, diastolic blood pressure <50 mmHg or >110 mmHg, pulse <50 beats per minute (bpm) or >120 bpm, body temperature <35.6 °C or >37.7 °C.|Baseline up to Day 14|The safety analysis set included all participants who received at least 1 dose of the study drug.|||Participants|||Count of Participants
2534497|NCT03237156|Primary|Number of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE)|An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment or study participation. A treatment-emergent adverse events (TEAE) is defined as an AE whose date of onset occurs on or after the start of study drug.|Baseline up to Day 14|The safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2534498|NCT03237065|Post-Hoc|Incidence of S-phosphate Level ≤1.0 mg/dL at Any Time From Baseline to Day 35|"Safety~Incidence of s-phosphate level ≤1.0 mg/dL at any time from baseline to day 35."|Baseline to day 35||||Participants|||Count of Participants
2534499|NCT03237065|Secondary|Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35|"Efficacy~Change in Transferrin Saturation (TSAT) from baseline to days 1, 7, 8, 14, 21, and 35.~TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron."|Baseline, days 1, 7, 8, 14, 21, and 35|Intention-To-Treat (ITT) analysis set: included all randomised subjects.|||percentage of saturation||Standard Deviation|Mean
2534500|NCT03237065|Secondary|Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35|"Efficacy~Change in s-ferritin from baseline to days 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Intention-To-Treat (ITT) analysis set: included all randomised subjects.|||ng/mL||Standard Deviation|Mean
2534501|NCT03237065|Secondary|Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35|"Efficacy~Change in hemoglobin (Hb) per gram iron from baseline to days 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Intention-To-Treat (ITT) analysis set: included all randomised subjects.|||g/dL per g of iron||Standard Deviation|Mean
2534502|NCT03237065|Secondary|Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions|"Safety~For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated."|Baseline to day 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||Participants|||Count of Participants
2534503|NCT03237065|Secondary|Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35|"Safety~Change in ionized calcium from baseline to days 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product|||mg/dL||Standard Deviation|Mean
2534504|NCT03237065|Secondary|Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35|"Safety~Change in intact Parathyroid hormone (PTH) from baseline to days 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||pg/mL||Standard Deviation|Mean
2534505|NCT03237065|Secondary|Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35|"Safety~Change in 24,25-Dihydroxyvitamin D (vitamin D 24.25) from baseline to days 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||ng/mL||Standard Deviation|Mean
2534506|NCT03237065|Secondary|Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35|"Safety~Change in 1,25-Dihydroxyvitamin D (vitamin D 1.25) from baseline to days 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||pg/mL||Standard Deviation|Mean
2534507|NCT03237065|Secondary|Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35|"Safety~Change in vitamin 25-Hydroxyvitamin D (vitamin D 25) from baseline to days 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||ng/mL||Standard Deviation|Mean
2534508|NCT03237065|Secondary|Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35|"Safety~Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) from baseline to days 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||RU/mL||Standard Deviation|Mean
2534509|NCT03237065|Secondary|Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35|"Safety~Change in concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) from baseline to day 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||pg/mL||Standard Deviation|Mean
2534512|NCT03237065|Secondary|Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35|"Safety~Absolute [∆] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35."|Baseline, days 1, 7, 8, 14, 21, and 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||mg/dL||Standard Deviation|Mean
2534513|NCT03237065|Secondary|Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level <2.0 mg/dL)|"Safety~Evaluate the proportion of subjects with hypophosphatemia (s-phosphate level <2.0 mg/dL) on day 35."|Baseline to day 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||Participants|||Count of Participants
2534514|NCT03237065|Secondary|Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL)|"Safety~Time with hypophosphatemia (i.e. time with s-phosphate level < 2.0 mg/dL) from baseline up to day 35.~The time with hypophosphatemia was calculated as the actual number of days from the first day where s-phosphate was <2 mg/dL until the first day when s-phosphate was ≥2 mg/dL. If the subject did not reach s-phosphate ≥2 mg/dL, the subject was regarded as censored on day 35."|Baseline to day 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||days||95% Confidence Interval|Median
2534515|NCT03237065|Primary|Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL)|"Safety~The incidence of hypophosphatemia (defined as s-phosphate <2 mg/dL) at any time from baseline up to day 35."|Baseline to day 35|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||Participants|||Count of Participants
2534516|NCT03237013|Secondary|Stress|Participants completed the Depression Anxiety Stress Scales Short Version (DASS-21) as a marker of trait level negative affect (Henry & Crawford, 2005). This 21-item self-report measure consists of three seven-item subscales: depression, anxiety, and stress. Items are measured along a 4-point scale (0 [not at all like me] to 3 [applied to me very much, or most of the time]); higher scores denote increased symptoms. Total sum scores for this instrument ranges from 0-63; scores for the stress symptom subscale range from 0-21.|1-month assessment||||units on a scale||Standard Deviation|Mean
2534517|NCT03237013|Secondary|Anxiety Symptoms|Participants completed the Depression Anxiety Stress Scales Short Version (DASS-21) as a marker of trait level negative affect (Henry & Crawford, 2005). This 21-item self-report measure consists of three seven-item subscales: depression, anxiety, and stress. Items are measured along a 4-point scale (0 [not at all like me] to 3 [applied to me very much, or most of the time]); higher scores denote increased symptoms. Total sum scores for this instrument ranges from 0-63; scores for the anxiety symptom subscale range from 0-21.|1-month assessment||||units on a scale||Standard Deviation|Mean
2534518|NCT03237013|Secondary|Depressive Symptoms|Participants completed the Depression Anxiety Stress Scales Short Version (DASS-21) as a marker of trait level negative affect (Henry & Crawford, 2005). This 21-item self-report measure consists of three seven-item subscales: depression, anxiety, and stress. Items are measured along a 4-point scale (0 [not at all like me] to 3 [applied to me very much, or most of the time]); higher scores denote increased symptoms. Total sum scores for this instrument ranges from 0-63; scores for the depressive symptom subscale range from 0-21.|1-month assessment||||units on a scale||Standard Deviation|Mean
2534519|NCT03237013|Secondary|State Negative Affect|State negative affect was measured using the negative affect subscale of the Positive and Negative Affect Scale-Short Form (PANAS-SF; Thompson, 2007). This self-report subscale consists of five items of the full ten-item measure. This subscale utilizes a five-point Likert-type scale ranging from 1 (never) to 5 (always). This measure is scored by summing all scores to these five items (range 5-25), with higher scores indicating greater state negative affect. For the purposes of this project, participants' item scores to these five items were averaged.|Post assessment||||units on a scale||Standard Deviation|Mean
2534520|NCT03237013|Secondary|State Positive Affect|State positive affect was measured using the positive affect subscale of the Positive and Negative Affect Scale-Short Form (PANAS-SF; Thompson, 2007). This self-report subscale consists of five items of the full ten-item measure. This subscale utilizes a five-point Likert-type scale ranging from 1 (never) to 5 (always). This measure is scored by summing all scores to these five items (range 5-25), with higher scores indicating greater state positive affect. For the purposes of this project, participants' item scores to these five items were averaged.|Post assessment||||units on a scale||Standard Deviation|Mean
2534521|NCT03237013|Secondary|Appearance Orientation|Trait level appearance orientation satisfaction was measured using the Appearance Schemas Inventory-Revised Short Form (ASI-R; Cash, Melnyk, & Hrabosky, 2004). This twenty-item self-report instrument assesses cognitive and behavioral investment in one's physical appearance. This measure utilizes a five-point scale (1 [definitely disagree] to 5 [definitely agree]), with total scores ranging from 20-100; higher scores indicate greater appearance investment. This measure is scored by averaging all scores to these twenty items (higher scores indicating greater appearance investment).|1-month assessment||||units on a scale||Standard Deviation|Mean
2534522|NCT03237013|Secondary|Trait Body Satisfaction|Trait level body satisfaction was measured using the Multidimensional Body-Self Relations Questionnaire-Appearance Evaluation subscale (MSBRQ-AE; Brown, Cash, & Mikulka, 1990; Cash, 2000). This seven-item self-report subscale utilizes a five-point scale (1 [definitely disagree] to 5 [definitely agree]) with possible score range of 7-35. This measure was scored by averaging all scores to these seven items, with higher scores indicating greater body satisfaction.|1-month assessment||||units on a scale||Standard Deviation|Mean
2534523|NCT03237013|Secondary|State Body Satisfaction|State level body satisfaction was measured using the Body Image States Scale (BISS; Cash, Fleming, Alindogan, Steadman, & Whitehead, 2002). This six-item self-report instrument utilizes a nine-point scale (1 [extremely dissatisfied] to 9 [extremely satisfied]); possible total scores range 6-54; higher scores indicate greater satisfaction. This measure is scored by averaging all scores to these six items, with higher average scores indicating greater body satisfaction.|Post-assessment||||units on a scale||Standard Deviation|Mean
2534524|NCT03237013|Secondary|Appearance Reasons Not to Tan|Participants completed the Appearance Reasons Not to Tan latent subscale of the Physical Appearance Reasons for Tanning Scale (PARTS; Cafri et al., 2006, 2008). This scale consists of two manifest subscales: Skin Damage and Skin Aging. These 9 items were scored along a five-point scale 1 (definitely disagree) to 5 (definitely agree) with a possible total score range of 9-45 (higher scores indicating greater agreement). Total scores are averaged to reflect the average agreement with attitudes to not tan; (higher average scores indicating greater agreement).|Post assessment and 1-month assessment||||units on a scale||Standard Deviation|Mean
2534525|NCT03237013|Secondary|Appearance Attitudes to Tan|Participants completed the Appearance Reasons to Tan latent subscale of the Physical Appearance Reasons for Tanning Scale (PARTS; Cafri et al., 2006, 2008). This scale consists of three manifest subscales: General Attractiveness, Acne, and Body Shape. These 19 items were scored along a five-point scale: 1 (definitely disagree) to 5 (definitely agree), with a possible total score range of 19-95 (higher scores indicating greater agreement). Total scores are averaged to reflect the average agreement with attitudes which may motivate one to tan (higher average scores indicating greater agreement).|Post assessment & 1-month assessment||||units on a scale||Standard Deviation|Mean
2534526|NCT03237013|Primary|Outdoor Tanning Intentions|A free-response items measuring intentional outdoor intentions in the next 30 days.|Post Assessment & 1-month assessment||||sessions in next month||Standard Deviation|Mean
2534527|NCT03237013|Primary|Indoor Tanning Intentions|A free-response items measuring intentional indoor intentions in the next 30 days.|Post assessment & 1-month assessment||||sessions in next month||Standard Deviation|Mean
2534528|NCT03237013|Primary|Number of Outdoor Tanning Sessions in the Last 30 Days|One free-response item measuring intentional outdoor frequency in the last 30 days|1-month assessment||||Sessions in last month||Standard Deviation|Mean
2534529|NCT03237013|Primary|Number of Indoor Tanning Sessions in the Last 30 Days|One free-response item measuring intentional indoor frequency in the last 30 days|1-month assessment||||Sessions in last month||Standard Deviation|Mean
2534530|NCT03236311|Secondary|Pharmacokinetic Parameter: SAR407899 Plasma Concentration||Day 1, 8, 15, 22, and Day 29|As the number of participants randomized fell well below target (10 vs. 78), hence no data was collected and no analysis was performed.||||||
2534531|NCT03236311|Secondary|Change From Baseline in Angina-induced Physical Limitation Assessed Using Seattle Angina Questionnaire Physical Limitation Scale (SAQ-PL) at Week 4|The SAQ-PL measures how common daily activities representing low, medium, and high exertional requirements were limited by angina (9 items). It was scored by assigning each response an ordinal value, beginning with 1 for the response that implied the 'lowest level of functioning' to 5 for 'not at all limited', and summing across the 9 items. The score of 9 items was then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100. The range of scores was 0 to 100, with higher scores indicates better functioning. A change of 10 points was considered to be clinically important.|Baseline, Week 4|As the number of participants randomized fell well below target (10 vs. 78), hence no data was collected and no analysis was performed.||||||
2534532|NCT03236311|Primary|Change From Baseline in Uncorrected Global Coronary Flow Reserve (CFR) at Week 4|Absolute change from baseline to Week 4 in uncorrected global CFR, as assessed by the central core laboratory. The global CFR is the ratio of absolute myocardial blood flow (MBF) at stress over that at rest. The MBF was assessed by 13N-ammonia or 82Rubidium positron emission tomography (PET) scan.|Baseline, Week 4|Analysis was performed on modified intent-to-treat (mITT) population that included all randomized participants analyzed according to the treatment group allocated by randomization; who received at least 1 dose or part of a dose of the investigational medicinal product (IMP) and with an evaluable primary efficacy endpoint.|||ratio||Standard Deviation|Mean
2534533|NCT03236168|Secondary|Number of Participants With Headlice|Assessed in the study population by physical examination of hair|3 Months after treatment|||||||
2534534|NCT03236168|Secondary|Number of Participants With Headlice|Assessed in the study population by physical examination of hair|48hrs after treatment|||||||
2534535|NCT03236168|Primary|Number of Participants With Headlice|Assessed in the study population by physical examination of hair|2 Weeks after treatment||||Participants|||Count of Participants
2534536|NCT03235817|Secondary|Mean Values of Respiratory Rate Compared Between Pressure Support Ventilation and Pressure Control Ventilation Groups.|Mean values of respiratory rate between 5 and 45 minutes compared between pressure support ventilation and pressure control ventilation groups.|Up to 45 minutes||||breaths per minute||Standard Deviation|Mean
2534537|NCT03235817|Secondary|Mean Values of Respiratory Rate Compared Between the Spontaneous Ventilation and Pressure Control Ventilation Groups.|Mean values of respiratory rate between 5 and 45 minutes compared between the spontaneous ventilation and pressure control ventilation groups.|Up to 45 minutes||||breaths per minute||Standard Deviation|Mean
2534538|NCT03235817|Secondary|Mean Values of Respiratory Rates Between Spontaneous Ventilation and Pressure Support Ventilation Groups.|Mean values of respiratory rate between 5 and 45 minutes compared between spontaneous ventilation and pressure support ventilation groups.|Up to 45 minutes||||breaths per minute||Standard Deviation|Mean
2534539|NCT03235817|Primary|Mean Values of ETCO2 and TV Compared Between the PSV and PCV Groups|Mean values of ETCO2 and TV between 5 and 45 minutes compared between the PSV and PCV groups|up to 45 minutes||||cc/kg||Standard Deviation|Mean
2534540|NCT03235817|Primary|Mean Values of ETCO2 and TV Compared Between the SV and PCV Groups|Mean values of ETCO2 and TV between 5 and 45 minutes compared between the SV and Pressure control ventilation (PCV) groups.|Up to 45 minutes||||cc/kg||Standard Deviation|Mean
2534541|NCT03235817|Primary|Mean Values of End-tidal Carbon Dioxide and Tidal Volume Compared Between the Spontaneous Ventilation and Pressure Support Ventilation Groups.|Mean values of end-tidal carbon dioxide (ETCO2) and tidal volume (TV) between 5 and 45 minutes compared between the spontaneous ventilation (SV) and pressure support ventilation groups (PSV).|Up to 45 minutes||||cc/kg||Standard Deviation|Mean
2534542|NCT03235726|Secondary|Part 1: Number of Participants With Medical Device Incidents in CCI15106|A medical device incident is any malfunction or deterioration in the characteristics and/or performance of a device as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a participant/user/other person or to a serious deterioration in his/her state of health.|Up to Day 19|Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.|||Participants|||Count of Participants
2534543|NCT03235726|Secondary|Part 2: Concentration of CCI15106 in ELF in Repeated Dose of Cohort B 60 mg|BAL samples for ELF concentration analysis of CCI15106 were collected up to Day 13.|Up to Day 13|BAL PK Population.|||Nanogram per milliliter||Standard Deviation|Mean
2542683|NCT02994732|Primary|Pharmacokinetics of 14C-labeled BVD-523(Radioactivity in Whole Blood and Plasma) AUC|Area under Curve (AUC), 0-24 hr|Collected over 15 dyas|All enrolled subjects|||hr*ng/ml||Standard Deviation|Mean
2534544|NCT03235726|Secondary|Part 1: Concentration of CCI15106 in Lung Epithelial Lining Fluid (ELF) in Repeated Dose of Cohort B 60 mg|Bronchoalveolar lavage samples for ELF concentration analysis of CCI15106 were collected up to Day 13. Participants who received at least one dose of study treatment and who underwent bronchoalveolar lavage (BAL) sampling and had post-dose lung ELF CCI15106 and urea concentration result were included in BAL PK Population.|Up to Day 13|BAL PK Population.|||Nanogram per milliliter||Standard Deviation|Mean
2534545|NCT03235726|Primary|Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C|Static air samples were collected on filters within air pumps positioned in two locations (bench and corner) in the room. Sampling devices attached to sampling pumps were used to measure CCI15106 concentration. Fixed location concentrations were measured in corner of room and on bench at back of room over 20 minutes and 60 minutes post-dosing.|Days 1, 7 and 14: 20 and 60 minutes post-dose|Bystander PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Microgram per cubic meter||Standard Deviation|Mean
2534546|NCT03235726|Primary|Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C|Personal exposure air samples were collected on filters placed on each bystander after the first daily dose at indicated time points. The filters were used to measure CCI15106 concentration in the person's breathing zone. Fixed location concentrations were measured near window, near door, back to wall and facing wall in the dosing room over 15 minutes post-dose. Each bystander had a filter attached to their study clothing. The filters were measured for CCI15106. This was a single measurement from the filter for each bystsander. The locations (near window, near door, back to wall and facing wall) were just to record where the bystander was located in the room.|Days 1, 7 and 14: 15 minutes post-dose|Bystander PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Microgram per cubic meter||Standard Deviation|Mean
2534547|NCT03235726|Primary|Part 1: Concentration of CCI15106 in Plasma of Bystanders: Cohort C|Blood samples were collected from bystanders 15 minutes after dosing at indicated time points. Bystander PK population consisted of participants who were present at least once in the room with the participant receiving the dose, undergo plasma PK sampling and had post-dose concentration result.|Days 1, 7 and 14: pre-dose, 15 minutes post-dose|Bystander PK Population. NA indicates that, data could not be analyzed because data was below level of quantification.|||Nanogram per milliliter||Standard Deviation|Mean
2534548|NCT03235726|Primary|Part 2 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.|Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours||Geometric Coefficient of Variation|Geometric Mean
2534549|NCT03235726|Primary|Part 1 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.|Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours||Geometric Coefficient of Variation|Geometric Mean
2534550|NCT03235726|Primary|Part 1 Cohort A: t1/2 After Repeated Dose Administration of CCI15106 30 mg|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of t1/2 data.|Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose|PK Population. NA indicates that, t1/2 of CCI15106 plasma concentration in healthy participant was estimated but considered unreliable as period over which they were calculated was less than twice resultant t1/2 in all cases. In addition, %AUCex was >20% in most cases. This was largely due to short period of sampling times.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2534551|NCT03235726|Primary|Part 2 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.|Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose|PK Population.|||Hours||Full Range|Median
2534552|NCT03235726|Primary|Part 1 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.|Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours||Full Range|Median
2534553|NCT03235726|Primary|Part 1 Cohort A: Tmax After Repeated Dose Administration of CCI15106 30 mg|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of tmax data.|Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose|PK Population.|||Hours||Full Range|Median
2534554|NCT03235726|Primary|Part 2 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.|Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose|PK Population. Only those participants with data available at the indicated time points were analyzed.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534555|NCT03235726|Primary|Part 1 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.|Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534556|NCT03235726|Primary|Part 1 Cohort A: Cmax After Repeated Dose Administration of CCI15106 30 mg|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of Cmax data.|Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose|PK Population.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534557|NCT03235726|Primary|Part 2 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.|Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534558|NCT03235726|Primary|Part 1 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.|Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534559|NCT03235726|Primary|Part 1 Cohort A: AUC From Time Zero to End of Dosing Interval (AUC[0-tau]) After Repeated Dose Administration of CCI15106 30 mg|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of AUC(0-tau) data.|Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose|PK Population. NA indicates that, AUC(0-tau) could not be calculated because t1/2 considered unreliable as period over which they were calculated was less than twice resultant t1/2 in all cases. In addition, percent AUCextrapolated (%AUCex) was >20% in most cases. This was largely due to short period of sampling times.|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534560|NCT03235726|Primary|Part 2 Cohort A: CL/F After Single Dose Administration of CCI15106 60 mg on Day 1|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.|Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose|PK Population. Only those participants with data available at the indicated time points were analyzed.|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2534561|NCT03235726|Primary|Part 1 Cohort A: CL/F After Single Dose Administration of CCI15106 120 mg on Day 3|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of CL/F data.|Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose|PK Population.|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2534562|NCT03235726|Primary|Part 1 Cohort A: Clearance (CL/F) After Single Dose Administration of CCI15106 60 mg on Day 1|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.|Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose|PK Population.|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2534563|NCT03235726|Primary|Part 2 Cohort A: t1/2 After Single Dose Administration of CCI15106 60 mg on Day 1|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.|Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose|PK Population. Only those participants with data available at the indicated time points were analyzed.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2534564|NCT03235726|Primary|Part 1 Cohort A: t1/2 After Single Dose Administration of CCI15106 120 mg on Day 3|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of t1/2 data.|Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose|PK Population.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2534565|NCT03235726|Primary|Part 1 Cohort A: Elimination Half-life (t1/2) After Single Dose Administration of CCI15106 60 mg on Day 1|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.|Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose|PK Population.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2534566|NCT03235726|Primary|Part 2 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 60 mg on Day 1|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.|Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose|PK Population. Only those participants with data available at the indicated time points were analyzed.|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534567|NCT03235726|Primary|Part 1 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 120 mg on Day 3|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-infinity) data.|Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose|PK Population.|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534568|NCT03235726|Primary|Part 1 Cohort A: AUC From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of CCI15106 60 mg on Day 1|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.|Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose|PK Population.|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534569|NCT03235726|Primary|Part 2 Cohort A: Tmax After Single Dose Administration of CCI15106 60 mg on Day 1|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.|Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose|PK Population.|||Hours||Full Range|Median
2534570|NCT03235726|Primary|Part 1 Cohort A: Tmax After Single Dose Administration of CCI15106 120 mg on Day 3|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of tmax data.|Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose|PK Population.|||Hours||Full Range|Median
2534571|NCT03235726|Primary|Part 1 Cohort A: Time of Maximum Concentration (Tmax) After Single Dose Administration of CCI15106 60 mg on Day 1|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.|Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose|PK Population.|||Hours||Full Range|Median
2534572|NCT03235726|Primary|Part 2 Cohort A: Cmax After Single Dose Administration of CCI15106 60 mg on Day 1|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.|Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose|PK Population.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534573|NCT03235726|Primary|Part 1 Cohort A: Cmax After Single Dose Administration of CCI15106 120 mg on Day 3|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of Cmax data.|Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose|PK Population.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534574|NCT03235726|Primary|Part 1 Cohort A: Maximum Observed Plasma Concentration (Cmax) After Single Dose Administration of CCI15106 60 mg on Day 1|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.|Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose|PK Population.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534575|NCT03235726|Primary|Part 2 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 60 mg on Day 1|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data.|Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dose|PK Population.|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534576|NCT03235726|Primary|Part 1 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 120 mg on Day 3|Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-t) data.|Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dose|PK Population.|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534577|NCT03235726|Primary|Part 1 Cohort A: Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of CCI15106 60 mg on Day 1|Blood samples were collected to evaluate the pharmacokinetics (PKs) of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data. PK population consisted of participants who received at least one dose of study treatment and who undergo plasma PK sampling and had at least one post-dose concentration result.|Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dose|PK Population.|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534578|NCT03235726|Primary|Part 2: Number of Participants With Vital Signs Values of PCI|PCI ranges for the vital signs parameters were as follows: SBP <85 and >160 mmHg, DBP <45 and >100 mmHg and heart rate <40 and >110 bpm. Data for the participants with high and low values has been reported.|Up to 46 days|Safety Population.|||Participants|||Count of Participants
2534579|NCT03235726|Primary|Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders|PCI ranges for the vital signs parameters were as follows: SBP <85 and >160 mmHg, DBP <45 and >100 mmHg and heart rate <40 and >110 bpm. Data for the participants with high and low values has been reported.|Up to 46 days|Safety Population.|||Participants|||Count of Participants
2534580|NCT03235726|Primary|Part 1: Number of Participants With Vital Signs Values of PCI|PCI ranges for the vital signs parameters were as follows: systolic blood pressure (SBP) <85 and >160 millimeters of mercury (mmHg), diastolic blood pressure (DBP) <45 and >100 mmHg and heart rate <40 and >110 beats per minute (bpm). Data for the participants with high and low values has been reported.|Up to 51 days|Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.|||Participants|||Count of Participants
2534581|NCT03235726|Primary|Part 2: Percent Predicted FVC at Indicated Time Points|FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)*100.|Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent predicted FVC||Standard Deviation|Mean
2534582|NCT03235726|Primary|Part 2: Percent Predicted FEV1 at Indicated Time Points|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)*100.|Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent predicted FEV1||Standard Deviation|Mean
2534583|NCT03235726|Primary|Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points|FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)*100.|Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.|||Percent predicted FVC||Standard Deviation|Mean
2534594|NCT03235726|Primary|Part 1 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID|Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).|Baseline (Day -1), Days 7 and 15|Safety Population.|||Ratio||Standard Deviation|Mean
2534584|NCT03235726|Primary|Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)*100.|Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.|||Percent predicted FEV1||Standard Deviation|Mean
2534585|NCT03235726|Primary|Part 2: Number of Participants With Abnormal Telemetry Findings|Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.|Days 1, 7, 12 and 13: 0.5 hour (pre-dose) to 4 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2534586|NCT03235726|Primary|Part 1: Number of Participants With Abnormal Telemetry Findings|Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.|Days 1, 3, 6, 7, 12 and 18: 0.5 hour (pre-dose) to 4 hours post-dose|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.|||Participants|||Count of Participants
2534587|NCT03235726|Primary|Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI|PCI ranges for the ECG parameters were as follows: absolute QTc interval >450 and <480, >=480 and <500, >=500 msec, absolute PR interval <110 and >220 msec and absolute QRS interval <75 and >110 msec. Data for worst case post-Baseline has been reported.|Up to 46 days|Safety Population.|||Participants|||Count of Participants
2534588|NCT03235726|Primary|Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander|PCI ranges for the ECG parameters were as follows: absolute QTc interval >450 and <480, >=480 and <500, >=500 msec, absolute PR interval <110 and >220 msec and absolute QRS interval <75 and >110 msec. Data for worst case post-Baseline has been reported.|Up to 46 days|Safety Population.|||Participants|||Count of Participants
2534589|NCT03235726|Primary|Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106|PCI ranges for the ECG parameters were as follows: absolute QTc interval >450 and <480, >=480 and <500, >=500 milliseconds (msec), absolute PR interval <110 and >220 msec and absolute QRS interval <75 and >110 msec. QTcF=Frederica's QT interval corrected for heart rate; QTcB=Bazett's QT interval corrected for heart rate. Data for worst case post-Baseline has been reported.|Up to 51 days|Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.|||Participants|||Count of Participants
2534590|NCT03235726|Primary|Part 2 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID|Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).|Baseline (Day -1), Days 7 and 15|Safety Population.|||Ratio||Standard Deviation|Mean
2534591|NCT03235726|Primary|Part 2 Cohort A: Specific Gravity Value by Visit- CCI15106|Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).|Baseline (Day -1) and Day 2|Safety Population.|||Ratio||Standard Deviation|Mean
2534592|NCT03235726|Primary|Part 1 Cohort C: Specific Gravity Value by Visit- CCI15106 in Bystanders|Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).|Baseline (Day -1), Days 7 and 15|Safety Population.|||Ratio||Standard Deviation|Mean
2534593|NCT03235726|Primary|Part 1: Specific Gravity Value by Visit- Placebo|Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).|Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.|||Ratio||Standard Deviation|Mean
2534740|NCT03233438|Secondary|Number of Participants With Infection-related Emergency Department (ED) Visits||44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.|||Participants|||Count of Participants
2534595|NCT03235726|Primary|Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 30 mg BID|Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity.|Days 12 and 22|Safety Population.|||Ratio||Standard Deviation|Mean
2534596|NCT03235726|Primary|Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 120 mg SD|Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine sample was collected from participants at indicated time point for analysis of specific gravity.|Day 5|Safety Population.|||Ratio||Standard Deviation|Mean
2534597|NCT03235726|Primary|Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 60 mg SD|Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).|Baseline (Day -1) and Day 2|Safety Population.|||Ratio||Standard Deviation|Mean
2534598|NCT03235726|Primary|Part 2 Cohort B: pH Value by Visit- CCI15106 60 mg BID|Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).|Baseline (Day -1), Days 7 and 15|Safety Population.|||pH||Standard Deviation|Mean
2534599|NCT03235726|Primary|Part 2 Cohort A: pH Value by Visit- CCI15106|Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).|Baseline (Day -1) and Day 2|Safety Population.|||pH||Standard Deviation|Mean
2534600|NCT03235726|Primary|Part 1 Cohort C: pH Value by Visit- CCI15106 in Bystanders|Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).|Baseline (Day -1), Days 7 and 15|Safety Population.|||pH||Standard Deviation|Mean
2534601|NCT03235726|Primary|Part 1: pH Value by Visit- Placebo|Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).|Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.|||pH||Standard Deviation|Mean
2534602|NCT03235726|Primary|Part 1 Cohort B: pH Value by Visit- CCI15106 60 mg BID|Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).|Baseline (Day -1), Days 7 and 15|Safety Population.|||pH||Standard Deviation|Mean
2534603|NCT03235726|Primary|Part 1 Cohort A: pH Value by Visit- CCI15106 30 mg BID|Urine samples were collected from participants at indicated time points for analysis of pH.|Days 12 and 22|Safety Population.|||pH||Standard Deviation|Mean
2534604|NCT03235726|Primary|Part 1 Cohort A: pH Value by Visit- CCI15106 120 mg SD|Urine sample was collected from participants at indicated time point for analysis of pH.|Day 5|Safety Population.|||pH||Standard Deviation|Mean
2534605|NCT03235726|Primary|Part 1 Cohort A: Potential of Hydrogen (pH) Value by Visit- CCI15106 60 mg SD|Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).|Baseline (Day -1) and Day 2|Safety Population.|||pH||Standard Deviation|Mean
2534606|NCT03235726|Primary|Part 2: Number of Participants With Clinical Chemistry Values of PCI|PCI ranges for the clinical chemistry parameters were as follows: albumin (low: <30 mmol/L), calcium (low: <2 mmol/L and high: >2.75 mmol/L), glucose (low: <3 mmol/L and high: >9 mmol/L), potassium (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Data for the participants with high and low values has been reported.|Up to 46 days|Safety Population.|||Participants|||Count of Participants
2534607|NCT03235726|Primary|Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders|PCI ranges for the clinical chemistry parameters were as follows: albumin (low: <30 mmol/L), calcium (low: <2 mmol/L and high: >2.75 mmol/L), glucose (low: <3 mmol/L and high: >9 mmol/L), potassium (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Data for the participants with high and low values has been reported.|Up to 46 days|Safety Population.|||Participants|||Count of Participants
2534608|NCT03235726|Primary|Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106|PCI ranges for the clinical chemistry parameters were as follows: albumin (low: <30 millimole per liter [mmol/L]), calcium (low: <2 mmol/L and high: >2.75 mmol/L), glucose (low: <3 mmol/L and high: >9 mmol/L), potassium (low: <3 mmol/L and high: >5.5 mmol/L) and sodium (low: <130 mmol/L and high: >150 mmol/L). Data for the participants with high and low values has been reported.|Up to 51 days|Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.|||Participants|||Count of Participants
2534609|NCT03235726|Primary|Part 2: Number of Participants With Hematology Values of PCI|PCI ranges for the hematology parameters were as follows: hematocrit (high: >0.54 proportion of RBC in blood for male, >0.54 proportion of RBC in blood for female), hemoglobin (high: >180 g/L in male, >180 g/L in female), lymphocytes (low: <0.8 10^9/L), neutrophil count (low: <1.5 10^9/L) and platelet count (low: <100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.|Up to 46 days|Safety Population.|||Participants|||Count of Participants
2535140|NCT03220048|Secondary|Secondary Efficacy Endpoint: Incidence(s) of Illness and Infection: Seroconversion|The number of subjects with seroconversion. Seroconversion was measured by the ratio of Influenza A/Perth/16/2009 (H3N2) virus antibodies at follow-up versus pre-dose.|8 days||||Participants|||Count of Participants
2534610|NCT03235726|Primary|Part 1: Number of Participants With Hematology Values of PCI in Bystanders|PCI ranges for the hematology parameters were as follows: hematocrit (high: >0.54 proportion of RBC in blood for male, >0.54 proportion of RBC in blood for female), hemoglobin (high: >180 g/L in male, >180 g/L in female), lymphocytes (low: <0.8 10^9/L), neutrophil count (low: <1.5 10^9/L) and platelet count (low: <100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.|Up to 46 days|Safety Population.|||Participants|||Count of Participants
2534611|NCT03235726|Primary|Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106|PCI ranges for the hematology parameters were as follows: hematocrit (high: >0.54 proportion of red blood cell [RBC] in blood for male, >0.54 proportion of RBC in blood for female), hemoglobin (high: >180 grams [g]/L in male, >180 g/L in female), lymphocytes (low: <0.8 10^9/L), neutrophil count (low: <1.5 10^9/L) and platelet count (low: <100 10^9/L and high: 550 10^9/L). Data for the participants with high and low values has been reported.|Up to 51 days|Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.|||Participants|||Count of Participants
2534612|NCT03235726|Primary|Part 2 Cohort B: Number of Participants With NSAEs and SAEs|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.|Up to 46 days|Safety Population.|||Participants|||Count of Participants
2534613|NCT03235726|Primary|Part 2 Cohort A: Number of Participants With NSAEs and SAEs|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.|Up to 33 days|Safety Population.|||Participants|||Count of Participants
2534614|NCT03235726|Primary|Part 1 Cohort C: Number of Participants With NSAEs and SAEs in Bystanders|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.|Up to 46 days|Safety Population.|||Participants|||Count of Participants
2534615|NCT03235726|Primary|Part 1 Cohort B: Number of Participants With NSAEs and SAEs in CCI15106|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.|Up to 46 days|Safety Population.|||Participants|||Count of Participants
2534616|NCT03235726|Primary|Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. Safety population comprised of all participants who received at least one dose of study treatment during the study.|Up to 51 days|Safety Population.|||Participants|||Count of Participants
2534617|NCT03235349|Secondary|Percentage of HCV/HIV Co-infected Participants Achieving SVR12|SVR12 was defined as plasma HCV RNA level less than LLOQ (15 IU/mL) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen|No HCV-HIV co-infected participants were enrolled in the study||||||
2534618|NCT03235349|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < 15 IU/mL at the end of treatment, excluding re-infection.|From the end of treatment (Week 12 or 16) through 12 weeks after the last dose of study drug (Weeks 24 or 28 depending on the treatment regimen).|All enrolled participants who received at least one dose of study drug, with HCV RNA < 15 IU/mL at the end of treatment, at least one post-treatment HCV RNA value, and who completed the assigned treatment.|||percentage of participants||95% Confidence Interval|Number
2534619|NCT03235349|Secondary|Percentage of Participants With On-treatment Virologic Failure|"On-treatment virologic failure was defined as meeting one of the following:~confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log₁₀ IU/mL above nadir) at any time point during the treatment period; or~confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA < 15 IU/mL during the treatment period, or~HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment."|12 or 16 weeks depending on the treatment regimen|All enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2534620|NCT03235349|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug, Week 24 or Week 28 depending on the treatment regimen.|All enrolled participants who received at least 1 dose of study drug. Backward imputation, where applicable, was used to impute missing data. Participants with missing data after backward imputation were counted as non-responders.|||percentage of participants||95% Confidence Interval|Number
2535141|NCT03220048|Secondary|Secondary Efficacy Endpoint: Incidence(s) of Illness and Infection: Viral Shedding|The number of subjects with viral shedding. Viral shedding was measured by PCR, testing the nasopharyngeal swab samples.|8 days||||Participants|||Count of Participants
2534621|NCT03235284|Secondary|Parkinson's Disease Questionnaire (PDQ-39)|"39 items divided into 8 domains. The total score ranges from 0 to 100, in which a lower score denotes a better perception of the patient's.~It is divided into eight categories: mobility (10 items), daily life activities (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (3 items) and body discomfort (3 items) .43 The score ranges from 0 (no problem) to 100 (maximum problem level), ie low score indicates the individual's perception of a better quality of life .. These items can be grouped into three domains: physical, mental and social. The score is made by rule of three and transformed into values from 0 to 100, and higher values refer to poorer quality of life."|8 weeks||||Score on a scale||Inter-Quartile Range|Median
2534622|NCT03235284|Secondary|Timed Up and Go - TUG|"The TUG measures, in seconds, the time it takes an individual to lift from a standard armchair (height of approximately 46 cm), walk a distance of 3 meters, turn, walk back to the chair and sit again.~The patient is asked to lift from a chair (seat height of 45 cm and arms from 65 cm) to walk 3 meters, return and sit again, while the time spent in performing this task is timed.~TUG up to ten seconds - individual without change of balance and with low risk of falls; (2) TUG between 11 and 20 seconds - individual with no significant alteration of balance, but presenting some fragility and medium risk of falls; (3) TUG greater than 20 seconds and less than 30 seconds - individual in need of intervention; (4) TUG greater than 30 seconds - individual at high risk for falls and with impaired mobility"|8 weeks||||Seconds||Standard Deviation|Mean
2534623|NCT03235284|Secondary|Dynamic Gait Index - DGI|It is a scale that allows a functional assessment of the balance of the performance. Comprising 8 tasks with a score ranging from 0 to 3 points, maximum score of 24 points and minimum score of 0 points It consists of eight tasks involving walking in different sensory contexts, which include flat surface, change in gait speed, horizontal and vertical head movements, overpassing and bypassing obstacles, turning over the body axis itself, going up and down stairs . The maximum score is 24 points, and a score of 19 points or less predicts risk of falls. The scale has no gaps, only cutoff points. The higher the value, the better the gait performance. For patients with Parkinson's disease, values below 19 points predict major gait problems and high risk of falls.|8 weeks||||Units on a scale||Standard Deviation|Mean
2534624|NCT03235284|Primary|Berg Balance Scale|"It is a scale that allows a functional assessment of the balance of the performance. It is based on 14 common items of everyday life, graduated from 0 to 4 points, reaching 56 points maximum score.~It presents test reliability and re-test of 98%, another particularity of the scale is the non-linear relationship between the score and the risk of corresponding falls. The scores range from 0 to 56, the higher the score, the better the assessed individual's balance. Each point less on the scale corresponds to an increased risk of falls; between scores 56 to 54, each minus point is associated with a 3 to 4% increase in the risk of falls; between 54 and 46 an increase of 6 to 8% of chances for each point, being that below 36 points the risk of falls is almost 100%"|8 weeks||||Score on a scale||Standard Deviation|Mean
2534625|NCT03235115|Primary|Lens Fit - Movement of Lens|Assessment of movement of lens on eye|Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn||||Participants|||Count of Participants
2534626|NCT03235115|Primary|Lens Fit - Corneal Coverage of Lens|Assessment of corneal coverage of lens on eye|Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn||||Participants|||Count of Participants
2534627|NCT03235115|Primary|Lens Fit - Vertical Centration|Assessment of vertical centration of lens on eye|Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn||||Participants|||Count of Participants
2534628|NCT03235115|Primary|Lens Fit - Horizontal Centration|Assessment of horizontal centration of lens on eye|Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn||||Participants|||Count of Participants
2534629|NCT03235115|Primary|Visual Acuity Using logMAR|Assessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction|Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn||||logMAR||Standard Deviation|Mean
2534630|NCT03234036|Secondary|Part 2: Accumulation Ratio Calculated From Ctau Following Administration of GSK2838232 as Non-boosted Once-daily Doses of a Tablet Formulation|Blood sample were collected at indicated time points to calculate accumulation ratio from Ctau following administration of GSK2838232 as non-boosted once-daily doses of a tablet formulation. Accumulation ratio of GSK2838232 was evaluated by Day 11, Ctau divided by Day 1, Ctau.|Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2|Pharmacokinetic Population|||Ratio of Ctau||Standard Deviation|Mean
2534631|NCT03234036|Secondary|Part 2: Accumulation Ratio Calculated From Cmax Following Administration of GSK2838232 as Non-boosted Once-daily Doses of a Tablet Formulation|Blood sample were collected at indicated time points to calculate accumulation ratio from Cmax following administration of GSK2838232 as non-boosted once-daily doses of a tablet formulation. Accumulation ratio of GSK2838232 was evaluated by Day 11, Cmax divided by Day 1, Cmax.|Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2|Pharmacokinetic Population|||Ratio of Cmax||Standard Deviation|Mean
2534632|NCT03234036|Secondary|Part 2: Accumulation Ratio Calculated From AUC(0-tau) Following Administration of GSK2838232 as Non-boosted Once-daily Doses of a Tablet Formulation|Blood sample were collected at indicated time points to calculate accumulation ratio from AUC(0-tau) following administration of GSK2838232 as non-boosted once-daily doses of a tablet formulation. Accumulation ratio of GSK2838232 was evaluated by Day 11, AUC (0-tau) divided by Day 1, AUC (0-tau).|Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2|Pharmacokinetic Population|||Ratio of AUC||Standard Deviation|Mean
2534633|NCT03234036|Secondary|Part 2: Slope of Pre-dose Concentration of GSK2838232 Administered as Non-boosted Once-daily Doses of a Tablet Formulation to Assess Achievement of Steady State|Blood sample were collected at indicated time points to assess pre-dose concentration of GSK2838232 when administered as non-boosted once-daily doses of a tablet formulation for 11 days in Part 2. Slope and 90 percent confidence interval have been presented.|Pre-dose on Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10 and Day 11 in Part 2|Pharmacokinetic Population|||Nanograms per milliliter per study day||90% Confidence Interval|Number
2534634|NCT03234036|Secondary|Part 1: AUC(0-t) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1|Pharmacokinetic Population|||Hours* nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534635|NCT03234036|Secondary|Part 1: Plasma Drug Concentration at 24 Hours (C24) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1|Pharmacokinetic Population|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534636|NCT03234036|Secondary|Part 1: Tlast Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1|Pharmacokinetic Population|||Hours||Full Range|Median
2534637|NCT03234036|Secondary|Part 1: T1/2 Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1|Pharmacokinetic Population|||Hours||Geometric Coefficient of Variation|Geometric Mean
2534638|NCT03234036|Secondary|Part 1: Tmax Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1|Pharmacokinetic Population|||Hours||Full Range|Median
2534639|NCT03234036|Secondary|Part 1: Tlag Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State and Tablet Formulation in Fasted State|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as capsule and tablet formulation in fed state as well as tablet formulation in fasted state. Tlag is a time delay between drug administration and first observed concentration. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1|Pharmacokinetic Population|||Hours||Full Range|Median
2534640|NCT03234036|Secondary|Part 1: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters|Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates measures PR, QRS, QT and QTcF intervals. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.|Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours on Day 1|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Milliseconds||Standard Deviation|Mean
2534641|NCT03234036|Secondary|Part 1: Change From Baseline in Mean Heart Rate Values as ECG Parameter|Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates the heart rate. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.|Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours on Day 1|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Beats per minute||Standard Deviation|Mean
2534642|NCT03234036|Secondary|Part 1: Number of Participants With Abnormal ECG Findings|Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTcF intervals. CS and NCS abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.|Day -2, Day -1; 1, 2, 4, 6, 8, , 12, 24, 48, 72 hours on Day 1|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2534643|NCT03234036|Secondary|Part 1: Change From Baseline in Pulse Rate|Pulse rate was measured in supine position after 10 minutes rest for the participant at indicated time points. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.|Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1|Safety Population|||Beats per minute||Standard Deviation|Mean
2534644|NCT03234036|Secondary|Part 1: Pulse Rate at Indicated Time Points|Pulse rate was measured in supine position after 10 minutes rest for the participant at indicated time points.|Day -2; Day -1; Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1|Safety Population|||Beats per minute||Standard Deviation|Mean
2536639|NCT03161938|Secondary|Pain Scores, PACU|Differences between groups in maximal and average pain score during PACU stay. Pain scores are measured on a numeric rating scale (NRS), 0-10. 0 is no pain, 10 is worst pain imaginable.|12 hours||||score on a scale (numeric rating scale)||Inter-Quartile Range|Median
2534645|NCT03234036|Secondary|Part 1: Change From Baseline in Blood Pressure|SBP and DBP were measured in supine position after 10 minutes rest for the participant at indicated time points. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.|Baseline (Day -1) and 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1|Safety Population|||Millimeter of mercury||Standard Deviation|Mean
2534646|NCT03234036|Secondary|Part 1: Blood Pressure at Indicated Time Points|SBP and DBP of participants were measured in supine position after 10 minutes rest at indicated time points.|Day -2; Day -1; Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 Hours on Day 1|Safety Population|||Millimeter of mercury||Standard Deviation|Mean
2534647|NCT03234036|Secondary|Part 1: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria|"Urine samples were collected from participants for analysis of following urinalysis parameters; specific gravity, pH, presence of glucose, protein, occult blood, ketones in urine analyzed by dipstick method. The dipstick test gives results in a semi-quantitative manner. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The reference range is 1.002-1.030. Urine pH is an acid-base measurement. Normal urine has a slightly acid pH (5.0 - 6.0). Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the To Normal or No Change category."|Up to 60 days|Safety Population|||Participants|||Count of Participants
2534648|NCT03234036|Secondary|Part 1: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria|"Blood samples were collected from participants for analysis of following clinical chemistry parameters; glucose, ALT, albumin, alkaline phosphatase, AST, bilirubin, calcium, potassium and sodium. PCI ranges were <30 g/L for albumin, <2 or 2.75 mmol/L for calcium, <3 or >9 mmol/L for glucose, >=2 times ULN U/L for ALT, >=2 times ULN U/L for alkaline phosphatase, >=2 times ULN U/L for AST, >=1.5 times ULN µmol/L for bilirubin, <3 or >5.5 mmol/L for potassium, and <130 or >150 mmol/L for sodium. Participants were counted in the worst case category that their value changes to (low, within range or no change,or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the To within Range or No Change category."|Up to 60 days|Safety Population|||Participants|||Count of Participants
2534649|NCT03234036|Secondary|Part 1: Number of Participants With Worst Case Hematology Results to PCI Criteria|"Blood samples were collected from participants for analysis of following hematology parameters; hematocrit, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. PCI ranges were >0.54 as proportion of red blood cells in blood for hematocrit, >180 g/L for hemoglobin, < 3 or >20 cells/L for leukocytes, 0.8 x10^9 cells/L for lymphocytes, 1.5 x10^9 cells/L for neutrophils, and <100 or >550 cells/L for platelets. Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the To within Range or No Change category."|Up to 60 days|Safety Population|||Participants|||Count of Participants
2534650|NCT03234036|Secondary|Part 1: Number of Participants With SAEs and Non-SAEs|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect, is associated with liver injury or impaired liver function or any other situations as per medical or scientific judgment. Number of participants with SAEs and common non-SAEs (>=5%) are presented.|Up to 60 days|Safety Population|||Participants|||Count of Participants
2534651|NCT03234036|Primary|Part 2: Time of Last Quantifiable Concentration (Tlast) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 11|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2|Pharmacokinetic Population|||Hours||Full Range|Median
2534652|NCT03234036|Primary|Part 2: Apparent Terminal Phase Half-life (T1/2) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 11|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2|Pharmacokinetic Population|||Hours||Geometric Coefficient of Variation|Geometric Mean
2534653|NCT03234036|Primary|Part 2: AUC(0-infinity) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 11|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2|Pharmacokinetic Population|||Hours*nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534654|NCT03234036|Primary|Part 2: Lag-time (Tlag) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State on Day 1|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Tlag is a time delay between drug administration and first observed concentration. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1 in Part 2|Pharmacokinetic Population|||Hours||Full Range|Median
2534736|NCT03233438|Secondary|Change From Baseline in Response to Treatment at End of Treatment Visit|Response to treatment (healthcare provider assessment) comparing response at the Day 14 visit. Response to treatment will be defined through an assessment of erythema (measurement of lesion characteristics) and the absence of fever|Baseline, Day 14|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.|||Participants|||Count of Participants
2534655|NCT03234036|Primary|Part 2: Tmax Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2|Pharmacokinetic Population|||Hours||Full Range|Median
2534656|NCT03234036|Primary|Part 2: Observed Concentration at the End of the Dosing Interval (Ctau) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2|Pharmacokinetic Population|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534657|NCT03234036|Primary|Part 2: Cmax Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2|Pharmacokinetic Population|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534658|NCT03234036|Primary|Part 2: Area Under the Plasma Drug Concentration Time Curve From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]) Following Administration of Non-boosted Once-daily Doses of GSK2838232 Tablet in Fed State|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as a non-boosted once-daily dosing tablet in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12 and 24 hours post-dose on Day 1; Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose on Day 11 in Part 2|Pharmacokinetic Population|||Hours*nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534659|NCT03234036|Primary|Part 2: Change From Baseline in PR Interval, QRS, QT Interval, and QTcF Interval as ECG Parameters|Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates measures PR, QRS, QT and QTcF intervals. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.|Baseline (Day -1) and 1, 4, 12 hours on Day 1; Days 2, 3 5, 8; Pre-dose, 1, 4, 12, 24 hours Day 11; Follow-up (Day 25)|Safety Population|||Milliseconds||Standard Deviation|Mean
2534660|NCT03234036|Primary|Part 2: Change From Baseline in Mean Heart Rate Values as ECG Parameter|Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates the heart rate. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.|Baseline (Day -1) and 1, 4, 12 hours on Day 1; Days 2, 3 5, 8; Pre-dose, 1, 4, 12, 24 hours Day 11; Follow-up (Day 25)|Safety Population|||Beats per minute||Standard Deviation|Mean
2534661|NCT03234036|Primary|Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Single and triplicate 12-lead ECG's were obtained at least 5 minutes apart in the supine position after 10 minutes of rest at indicated time points using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.|Day -1; 1, 4, 12 hours on Day 1; Days 2, 3, 5, 8; 1, 4, 12, 24 Hours on Day 11; Follow-up (Day 25)|Safety Population|||Participants|||Count of Participants
2534662|NCT03234036|Primary|Part 2: Change From Baseline in Pulse Rate|Pulse rate was measured in supine position after 10 minutes rest at indicated time points. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.|Baseline (Day -1) and 1, 4 hours on Day 1; 24 hours (Day 2); 48 hours (Day 3); 72 hours (Day 4), Days 5, 6, 7, 8, 9, 10; Pre-dose, 1, 4 , 24, 48, 72 hours on Day 11; Follow-up (Day 25)|Safety Population|||Beats per minute||Standard Deviation|Mean
2534663|NCT03234036|Primary|Part 2: Pulse Rate at Indicated Time Points|Pulse rate of participants was measured in supine position after 10 minutes rest at indicated time points.|Day -1; Pre-dose, 1, 4 hours on Day 1; 24 hours (Day 2); 48 hours (Day 3); 72 hours (Day 4), Days 5, 6, 7, 8, 9, 10; Pre-dose, 1, 4 , 24, 48, 72 hours on Day 11; Follow-up (Day 25)|Safety Population|||Beats per minute||Standard Deviation|Mean
2534664|NCT03234036|Primary|Part 2: Change From Baseline in Blood Pressure|SBP and DBP were measured in supine position after 10 minutes rest for participants at indicated time points. Baseline was defined as the latest pre-dose assessment, including those from unscheduled visits. Change from Baseline was defined as any visit value minus Baseline value.|Baseline (Day -1) and 1, 4 hours on Day 1; 24 hours (Day 2); 48 hours (Day 3); 72 hours (Day 4), Days 5, 6, 7, 8, 9, 10; Pre-dose, 1, 4 , 24, 48, 72 hours on Day 11; Follow-up (Day 25)|Safety Population|||Millimeter of mercury||Standard Deviation|Mean
2534665|NCT03234036|Primary|Part 2: Blood Pressure at Indicated Time Points|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured in supine position after 10 minutes rest for the participants at indicated time points.|Day -1; Pre-dose, 1, 4 hours on Day 1; 24 hours (Day 2); 48 hours (Day 3); 72 hours (Day 4), Days 5, 6, 7, 8, 9, 10; Pre-dose, 1, 4 , 24, 48, 72 hours on Day 11; Follow-up (Day 25)|Safety Population|||Millimeter of mercury||Standard Deviation|Mean
2534737|NCT03233438|Secondary|Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy||44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.|||Participants|||Count of Participants
2534666|NCT03234036|Primary|Part 2: Number of Participants With Worst Case Urinalysis Results Relative to Normal Range Criteria|"Urine samples were collected from participants for analysis of following urinalysis parameters; specific gravity, potential of hydrogen (pH), presence of glucose, protein, occult blood, ketones in urine analyzed by dipstick method. The dipstick test gives results in a semi-quantitative manner. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The reference range is 1.002-1.030. Urine pH is an acid-base measurement. Normal urine has a slightly acid pH (5.0 - 6.0). Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became normal, were recorded in the To Normal or No Change category."|Up to 25 days|Safety Population|||Participants|||Count of Participants
2534667|NCT03234036|Primary|Part 2: Number of Participants With Worst Case Clinical Chemistry Results to PCI Criteria|"Blood samples were collected from participants for analysis of following clinical chemistry parameters; glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), bilirubin, calcium, potassium and sodium. PCI ranges were <30 g/L for albumin, <2 or >2.75 millimoles per liter (mmol/L) for calcium, <3 or >9 mmol/L for glucose, >=2 times Upper limit of Normal (ULN) units per liter (U/L) for ALT, >=2 times ULN U/L for alkaline phosphatase, >=2 times ULN U/L for AST, >=1.5 times ULN micromoles per liter (µmol/L) for bilirubin, <3 or >5.5 mmol/L for potassium, and <130 or >150 mmol/L for sodium. Participants were counted in the worst case category that their value changes to (low, within range or no change,or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the To within Range or No Change category."|Up to 25 days|Safety Population|||Participants|||Count of Participants
2534668|NCT03234036|Primary|Part 2: Number of Participants With Worst Case Hematology Results to Potential Clinical Importance (PCI) Criteria|"Blood samples were collected from participants for analysis of following hematology parameters; hematocrit, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. PCI ranges were < 0.075 or >0.54 proportion of red blood cells in blood for hematocrit, <25 or >180 grams per liter (g/L) for hemoglobin, < 3 or >20 cells per liter (cells/L) for leukocytes, 0.8 x10^9 cells/L for lymphocytes, 1.5 x10^9 cells/L for neutrophils, and <100 or >550 cells/L for platelets. Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (example given [e.g.], High to High), or whose value became within range, were recorded in the To within Range or No Change category."|Up to 25 days|Safety Population|||Participants|||Count of Participants
2534669|NCT03234036|Primary|Part 2: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs|An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect, is associated with liver injury or impaired liver function or any other situations as per medical or scientific judgment. Safety Population comprised of all participants who received at least 1 dose of the study treatment (including placebo) with at least 1 post-Baseline safety assessment. Number of participants with SAEs and common non-SAEs (>=5%) are presented.|Up to 25 days|Safety Population|||Participants|||Count of Participants
2534670|NCT03234036|Primary|Part 1: Time of Occurrence of Cmax (Tmax) Following Administration of GSK2838232 Tablet in Fasted and Fed State|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet formulation in fed and fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1|Pharmacokinetic Population|||Hours||Full Range|Median
2534671|NCT03234036|Primary|Part 1: Cmax Following Administration of GSK2838232 Tablet in Fasted and Fed State|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet formulation in fed and fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1|Pharmacokinetic Population|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534672|NCT03234036|Primary|Part 1: AUC (0-infinity) Following Administration of GSK2838232 Tablet in Fasted and Fed State|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet formulation in fed and fasted state. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1, 2 and 3 of Part 1|Pharmacokinetic Population|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534673|NCT03234036|Primary|Part 1: Maximum Observed Concentration (Cmax) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet and capsule formulation in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1 and 2 of Part 1|Pharmacokinetic Population|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534674|NCT03234036|Primary|Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Administration of GSK2838232 Tablet and Capsule Formulation in Fed State|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232 given as tablet and capsule formulation in fed state. Pharmacokinetic parameters were determined using standard non-compartmental methods. Pharmacokinetic Population comprised of all participants in the Safety Population who had at least 1 non-missing pharmacokinetic assessment (Non-quantifiable [NQ] values were considered as non-missing values).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose in treatment periods 1 and 2 of Part 1|Pharmacokinetic Population|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534675|NCT03233737|Secondary|Stage I: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc)|"STID was calculated as a sum of the delta QST Heat scores at each time point until the designated time point. The delta QST Heat score is defined as the change in QST Heat score from baseline. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~The total possible scale range was from -155 ºC (best) to +155 ºC (worst) for STID at the 30 minute time point, and from -248 ºC (best) to +248 ºC (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective).~Stage I outcome."|Up to one hour post-application||||Degrees Celcius (ºC)||Standard Deviation|Mean
2534676|NCT03233737|Secondary|Stage I: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc)|"SPID was calculated as a sum of the delta PPT scores at each time point until the designated time point. The delta PPT score is defined as the change in PPT score from baseline. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~The total possible scale range was from -100 (best) to +100 (worst) for SPID at the 30 minute time point, and from -160 (best) to +160 (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective).~Stage I outcome."|Up to one hour post-application||||score||Standard Deviation|Mean
2534677|NCT03233737|Secondary|Stage I: Percentage of Subjects Reaching Minimal Pain on Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)|"Response is defined as a subject having a PPT average pain score of ≤2 recorded at any single time point where PPT was performed. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage I outcome."|Any time within one hour post-application|Placebo percentage of response was not analyzed.|||Participants|||Count of Participants
2534678|NCT03233737|Secondary|Stage I: Onset of Anesthesia for Heat Sensation Threshold (QST Heat)|"Onset of anesthesia was defined by Pin Prick Test (PPT) unless specific QST thresholds were not met.~If the PPT Onset was 5 minutes or less, then QST must have been greater than the Baseline QST temperature at 5 minutes by any amount and QST must have been ≥ 3 °C of the Baseline QST at 5 or 10 minutes.~If the PPT Onset was 10 minutes, then QST must have been ≥ 3 °C of the Baseline QST temperature at 10 minutes.~If PPT did not achieve Onset, then QST alone could have achieved onset at either 5 or 10 minutes if QST was greater than the Baseline QST temperature at 5 or 10 minutes by any amount and the QST was ≥ 3 °C of the Baseline QST at 5 or 10 minutes.~QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage I outcome."|Up to one hour post-application||||minutes||Standard Deviation|Mean
2534679|NCT03233737|Secondary|Stage I: Onset of Anesthesia for Pin Prick Test (PPT)|"Onset of anesthesia was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than the Baseline PPT. Onset was expected to be between 1 and 5 minutes. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage I outcome."|Up to one hour post-application||||minutes||Standard Deviation|Mean
2534680|NCT03233737|Secondary|Stage I: Percentage of Subjects Reaching Maximum Heat for Heat Sensation Threshold (QST Heat)|"QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Reaching maximum heat for QST Heat was defined as subjects reaching the maximum temperature without reporting pain at one or more time points.~Stage I outcome."|Any time within one hour post-application||||Participants|||Count of Participants
2534681|NCT03233737|Secondary|Stage I: Duration of Minimal Pain for Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)|"Response at a time point is defined as having the PPT average pain score of ≤2. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage I outcome."|Up to one hour post-application||||minutes||Standard Deviation|Mean
2534682|NCT03233737|Secondary|Stage I: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point|"Response at a time point is defined as an increase of QST heat pain temperature by ≥ 3 degrees C compared to the Baseline QST. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage I outcome."|Time of application up to one hour post-application||||Participants|||Count of Participants
2534683|NCT03233737|Secondary|Stage I: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point|"Response at at time point is defined as when the PPT average pain score was less than the Baseline PPT average score by any amount. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage I outcome."|Time of application up to one hour post-application||||Participants|||Count of Participants
2534699|NCT03233529|Secondary|Change From Baseline in Lesion Severity as Measured by Pruritus Numerical Rating Scale (NRS) at Each Visit up to Day 15|The intensity of pruritus was assessed by an NRS, which was a numeric rating scale ranging from 0 (no itching) to 10 (worst imaginable itching), with higher score indicating greater severity.|Baseline (Day 1), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15|"Number of Participants Analyzed signifies the number of participants who received at least 1 dose of investigational product. Number Analyzed refers to the number of evaluable participants for specified time points."|||units on a scale||Standard Error|Mean
2536640|NCT03161938|Secondary|Lenght of Stay, Hospital|Total lenght of stay, Hospital|1 week||||hours||Inter-Quartile Range|Median
2534684|NCT03233737|Secondary|Stage II: Sum of Temperature Differences (STID) for Heat Sensation Threshold (QST Heat) (Post-hoc)|"STID was calculated as a sum of the delta QST Heat scores at each time point until the designated time point. The delta QST Heat score is defined as the change in QST Heat score from baseline. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~The total possible scale range was from -155 ºC (best) to +155 ºC (worst) for STID at the 30 minute time point, and from -248 ºC (best) to +248 ºC (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective).~Stage II outcome."|Up to one hour post-application||||Degrees Celcius (ºC)||Standard Deviation|Mean
2534685|NCT03233737|Secondary|Stage II: Sum of Pain Intensity Differences (SPID) for Pin Prick Test (PPT) (Post-hoc)|"SPID was calculated as a sum of the delta PPT scores at each time point until the designated time point. The delta PPT score is defined as the change in PPT score from baseline. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~The total possible scale range was from -100 (best) to +100 (worst) for SPID at the 30 minute time point, and from -160 (best) to +160 (worst) for SPID at the 60 minute time point Lower scores signify a better outcome (less sensitive to pain than at baseline = less pain with therapy = therapy was more effective).~Stage II outcome."|Up to one hour post-application||||score||Standard Deviation|Mean
2534686|NCT03233737|Secondary|Stage II: Percentage of Subjects Reaching Maximum Heat for Heat Sensation Threshold (QST Heat)|"QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. Reaching maximum heat for QST Heat was defined as subjects reaching the maximum temperature without reporting pain at one or more time points.~Stage II outcome."|Any time within one hour post-application||||Participants|||Count of Participants
2534687|NCT03233737|Secondary|Stage II: Duration of Minimal Pain for Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)|"Response at a time point is defined as having the PPT average pain score of ≤2. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage II outcome."|Up to one hour post-application||||minutes||Standard Deviation|Mean
2534688|NCT03233737|Secondary|Stage II: Percentage of Subjects Reaching Minimal Pain on Pin Prick Test (PPT) (≤2 on Numerical Rating Scale Pain Scale)|"Response is defined as a subject having a PPT average pain score of ≤2 recorded at any single time point where PPT was performed. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage II outcome."|Any time within one hour post-application||||Participants|||Count of Participants
2534689|NCT03233737|Secondary|Stage II: Percentage of Responders for Heat Sensation Threshold (QST Heat) at Each Time Point|"Response at a time point is defined as an increase of QST heat pain temperature by ≥ 3 degrees C compared to the Baseline QST.~QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage II outcome."|Up to one hour post-application||||Participants|||Count of Participants
2534690|NCT03233737|Secondary|Stage II: Percentage of Responders for Pin Prick Test (PPT) at Each Time Point|"Response at at time point is defined as when the PPT average pain score was less than the Baseline PPT average score by any amount. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage II outcome."|Up to one hour post-application||||Participants|||Count of Participants
2534691|NCT03233737|Secondary|Stage II: Onset of Anesthesia for Heat Sensation Threshold (QST Heat)|"Onset of anesthesia was defined by Pin Prick Test (PPT) unless specific QST thresholds were not met.~If the PPT Onset was 5 minutes or less, then QST must have been greater than the Baseline QST temperature at 5 minutes by any amount and QST must have been ≥ 3 °C of the Baseline QST at 5 or 10 minutes.~If the PPT Onset was 10 minutes, then QST must have been ≥ 3 °C of the Baseline QST temperature at 10 minutes.~If PPT did not achieve Onset, then QST alone could have achieved onset at either 5 or 10 minutes if QST was greater than the Baseline QST temperature at 5 or 10 minutes by any amount and the QST was ≥ 3 °C of the Baseline QST at 5 or 10 minutes.~QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage II outcome."|Up to one hour post-application||||minutes||Standard Deviation|Mean
2534692|NCT03233737|Secondary|Stage II: Onset of Anesthesia for Pin Prick Test (PPT)|"Onset of anesthesia was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than the Baseline PPT. Onset was expected to be between 1 and 5 minutes. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage II outcome."|Up to one hour post-application||||minutes||Standard Deviation|Mean
2534700|NCT03233529|Secondary|Change From Baseline in Lesion Severity as Measured by Investigator Static Global Assessment (ISGA) at Day 8 and Day 15|The lesion ISGA is an assessment of target lesion severity of atopic dermatitis. The lesion ISGA score ranges from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe), with higher score representing greater severity.|Baseline (Day 1), Days 8 and 15|"Number of Participants Analyzed signifies the number of participants who received at least 1 dose of investigational product. Number Analyzed refers to the number of evaluable participants for specified time points."|||units on a scale||Standard Error|Mean
2536641|NCT03161938|Secondary|Lenght of Stay, PACU|Total lenght of stay in PACU|24 hours||||hours||Inter-Quartile Range|Median
2534693|NCT03233737|Primary|Stage I: Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Compared to One Spray CTY-5339-P (Placebo: Vehicle Control)|"The duration of effect, was defined as the time from onset to treatment failure, as measured by QST Heat score. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The QST Heat-based Duration of effect was calculated by the length of time in minutes from onset of anesthesia to the absence of anesthesia where Onset of anesthesia was defined by PPT unless specific QST thresholds were not met. After Onset had been established, absence of analgesia or offset was the first of two time points with consecutive occurrences of regression or absence of analgesia. Reports of QST heat pain temperature by ≥ 3 °C of the Baseline QST indicated analgesia; while a report of similar (<3 °C) than Baseline indicated regression or absence of analgesia. Stage I outcome."|Up to one hour post-application||||minutes||Standard Deviation|Mean
2534694|NCT03233737|Primary|Stage I: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB Compared to One Spray CTY-5339-P (Placebo: Vehicle Control)|"The duration of effect, was defined as the length of time in minutes from onset of anesthesia to the absence of anesthesia.Onset was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than Baseline. Absence of anesthesia was defined as follows: After Onset had been established, absence was the first of two time points with consecutive occurrences of regression of absence of analgesia. Reports of less pain by ≥1 unit than Baseline indicated analgesia; while a report of similar (< 1 unit) or more pain than Baseline indicated regression or absence of analgesia. The minimum onset time was 1 minute. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage I outcome."|Up to one hour post-application|Placebo duration of effect was not analyzed.|||minutes||Standard Deviation|Mean
2534695|NCT03233737|Primary|Stage II: Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB|"The duration of effect, was defined as the time from onset to treatment failure, as measured by QST Heat score. QST Heat scores were the temperature where the sensation of a heat stimuli was felt: ranging from 35 ºC to a maximum of 50.5 ºC with intervals of 0.5 ºC, at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point. The QST Heat-based Duration of effect was calculated by the length of time in minutes from onset of anesthesia to the absence of anesthesia where Onset of anesthesia was defined by PPT unless specific QST thresholds were not met. After Onset had been established, absence of analgesia or offset was the first of two time points with consecutive occurrences of regression or absence of analgesia. Reports of QST heat pain temperature by ≥ 3 °C of the Baseline QST indicated analgesia; while a report of similar (<3 °C) than Baseline indicated regression or absence of analgesia. Stage"|Up to one hour post-application||||minutes||Standard Deviation|Mean
2534696|NCT03233737|Primary|Stage II: Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB|"The duration of effect, was defined as the length of time in minutes from onset of anesthesia to the absence of anesthesia.Onset was the time point at which the PPT average pain score was less than the Baseline PPT average score by any amount. Also, in 10 minutes or less, the subject must have had a lower PPT average pain score of ≥ 1 unit than Baseline. Absence of anesthesia was defined as follows: After Onset had been established, absence was the first of two time points with consecutive occurrences of regression of absence of analgesia. Reports of less pain by ≥1 unit than Baseline indicated analgesia; while a report of similar (< 1 unit) or more pain than Baseline indicated regression or absence of analgesia. The minimum onset time was 1 minute. PPT scores were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale at a frequency of every 1 minute for the first 5 minutes and then every 5 minutes thereafter until the final 60 minute time point.~Stage II outcome."|Up to one hour post-application||||minutes||Standard Deviation|Mean
2534697|NCT03233529|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term, Which Occurred in the Treatment Area During the Double-Blind Period|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Treatment-emergent AEs were those with initial onset or increasing in severity on or after the first dose of study treatment. During double-blind period, there were a total of 2 treatment areas (for target lesions) for each participant. For this outcome measure, treatment-emergent AEs occurred at each treated area during double-blind period were summarized. MedDRA version 21.0 coding dictionary was used.|From first dose of study treatment (on Day 1) to Day 15 skin biopsy collection|This outcome measure was summarized by the treatment areas during the double-blind period; therefore, the analysis population here represents the participants who received at least 1 dose of investigational product for each treatment area in double-blind period.|||Participants|||Count of Participants
2534698|NCT03233529|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) by Treatment Groups|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs. Treatment-emergent AEs were those with initial onset or increasing in severity on or after the first dose of study treatment. Each participant received both crisaborole (for one target lesion) and vehicle (for the other target lesion) on the same days during double-blind period, and only crisaborole during open-label period; therefore AEs were reported for each treatment group for participants to capture all AEs, instead of each treatment for treated area as it only captures AEs occurred at treated areas (see next Outcome Measure).|From first dose of study treatment up to Day 71|All participants in each treatment group who received at least 1 dose of investigational product.|||Participants|||Count of Participants
2536642|NCT03161938|Primary|Number of Participants With Moderate to Severe Postoperative Pain|Moderate to severe pain (NRS > 3) in the post-anesthesia care unit (PACU)|12 hours||||Participants|||Count of Participants
2534701|NCT03233529|Secondary|Change From Baseline in Lesion Severity as Measured by TSS at Day 8|The lesion TSS is an assessment of target lesion severity based on the severity of the following 4 clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each of which was rated on a scale of 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). These 4 ratings were then added to create the TSS, which ranges from 0 (none) to 12 (most severe), with higher score representing greater severity.|Baseline (Day 1), Day 8|All randomized participants who received at least 1 dose of investigational product.|||units on a scale||Standard Error|Mean
2534702|NCT03233529|Secondary|Number of Participants With Categorical KRT16 Expression at Day 15|KRT16 expression was studied using IHC and categorized as no change, slight improvement, good improvement, excellent improvement, or worsening by a blinded expert pathologist based on visual scoring.|Day 15|All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.|||Participants|||Count of Participants
2534703|NCT03233529|Secondary|Number of Participants With Categorical Histological Response at Day 15|Histological response was studied using IHC and categorized as non-responder or responder by a blinded expert pathologist based on a global assessment of all thickness, KRT16 and FLG stains.|Day 15|All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.|||Participants|||Count of Participants
2534704|NCT03233529|Secondary|Number of Participants With Categorical Filaggrin (FLG) Expression at Day 15|FLG expression was studied using IHC and categorized as no change, partial normalization, full normalization, or worsening by a blinded expert pathologist based on visual scoring.|Day 15|All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.|||Participants|||Count of Participants
2534705|NCT03233529|Secondary|Change From Baseline in Expression of Other Skin Biomarkers (CCL13, Etc) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15|TLDA RT PCR was used to analyze the following other skin biomarkers: CCL13, CCL20, CCL26, CRLF2, CXCL1, CXCL2, CXCL9, CXCL10, DEFB4A, filaggrin (FLG), FOXP3, IFNG, IL-1B, IL-2, IL-2RA, IL-5, IL-6, IL-8, IL-9, IL-10, IL-12A, IL-15, IL-15RA, IL-17A, IL-17F, IL-19, IL-22, IL-23A, IL-31, IL-32, LOR, MMP-12, PDE4A, PDE4B, PDE4D, PPL, RNA18SP5, S100A7, S100A8, and S100A9. Expression levels were normalized to the housekeeping gene RPLP0 and log2-transformed prior to analysis.|Baseline (Day 1), Day 15|All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.|||log2(normalized expression)||Standard Error|Mean
2534706|NCT03233529|Secondary|Change From Baseline in Expression of Other Skin Biomarkers (CD11c, CD3, FceR1, Ki67, Langerin) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15|CD11c+ dendritic cells (DCs), CD3+ T cells, FcEpsilon + DCs, Ki 67+ cells, and langerin+ cells (for langerhans cells) were studied using IHC. These parameters were referred to as CD11c, CD3, FceR1, Ki67, langerin, respectively, in the outcome measure title above and data table below. Expression data were log2-transformed.|Baseline (Day 1), Day 15|All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.|||log2-scale cells per square millimeter||Standard Error|Mean
2534707|NCT03233529|Secondary|Change From Baseline in Expression of Other Skin Biomarker (Epidermal Thickness) in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15|Epidermal thickness was one of the other skin biomarkers of atopic dermatitis and was studied using immunohistochemistry (IHC). Expression data were log2-transformed.|Baseline (Day 1), Day 15|All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.|||log2-scale micrometers||Standard Error|Mean
2534708|NCT03233529|Primary|Change From Baseline in Key Skin Biomarker S100 Calcium Binding Protein A12 (S100A12) Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15|S100A12 is one of the key skin biomarkers of atopic dermatitis. Expression levels tested by TLDA RT PCR were normalized to the housekeeping gene RPLP0 and log2-transformed prior to analysis.|Baseline (Day 1), Day 15|All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.|||log2(normalized expression)||Standard Error|Mean
2534709|NCT03233529|Primary|Change From Baseline in Key Skin Biomarker Elafin/Peptidase Inhibitor 3 (PI3) Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15|Elafin/PI3 is one of the key skin biomarkers of atopic dermatitis. Expression levels tested by TLDA RT PCR were normalized to the housekeeping gene RPLP0 and log2-transformed prior to analysis.|Baseline (Day 1), Day 15|All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.|||log2(normalized expression)||Standard Error|Mean
2534710|NCT03233529|Primary|Change From Baseline in Key Skin Biomarker Keratin 16 (KRT16) Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15|KRT16 is one of the key skin biomarkers of atopic dermatitis. Expression levels tested by TLDA RT PCR were normalized to the housekeeping gene RPLP0 and log2-transformed prior to analysis.|Baseline (Day 1), Day 15|All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.|||log2(normalized expression)||Standard Error|Mean
2534735|NCT03233438|Secondary|Number of Participants With Serious Adverse Events (SAEs)||44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.|||Participants|||Count of Participants
2534711|NCT03233529|Primary|Change From Baseline in Key Skin Biomarker Interleukin (IL)-13 Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15|IL-13 is one of the key skin biomarkers of atopic dermatitis. Expression levels tested by TLDA RT PCR were normalized to the housekeeping gene RPLP0 and log2-transformed prior to analysis.|Baseline (Day 1), Day 15|All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.|||log2(normalized expression)||Standard Error|Mean
2534712|NCT03233529|Primary|Change From Baseline in Key Skin Biomarker CCL22 Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15|CCL22 is one of the key skin biomarkers of atopic dermatitis. Expression levels tested by TLDA RT PCR were normalized to the housekeeping gene RPLP0 and log2-transformed prior to analysis.|Baseline (Day 1), Day 15|All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.|||log2(normalized expression)||Standard Error|Mean
2534713|NCT03233529|Primary|Change From Baseline in Key Skin Biomarker CCL18 Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15|CCL18 is one of the key skin biomarkers of atopic dermatitis. Expression levels tested by TLDA RT PCR were normalized to the housekeeping gene RPLP0 and log2-transformed prior to analysis.|Baseline (Day 1), Day 15|All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.|||log2(normalized expression)||Standard Error|Mean
2534714|NCT03233529|Primary|Change From Baseline in Key Skin Biomarker Chemokine Ligand (CCL)17 Expression in Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15|CCL17 is one of the key skin biomarkers of atopic dermatitis. Expression levels tested by Taqman low density array (TLDA) reverse-transcriptase (RT) polymerase chain reaction (PCR) were normalized to the housekeeping gene ribosomal protein lateral stalk subunit P0 (RPLP0) and log2-transformed prior to analysis.|Baseline (Day 1), Day 15|All randomized participants who received at least 1 dose of investigational product, with both Day 1 and Day 15 biopsies done, and without protocol violations that were thought to impact the biomarker expression during the double-blind vehicle-controlled period.|||log2(normalized expression)||Standard Error|Mean
2534715|NCT03233529|Primary|Change From Baseline in Lesion Total Sign Score (TSS) for Target Lesions Treated With Crisaborole Ointment 2% or Vehicle at Day 15|The lesion TSS is an assessment of target lesion severity based on the severity of the following 4 clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each of which was rated on a scale of 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). These 4 ratings were then added to create the TSS, which ranges from 0 (none) to 12 (most severe), with higher score representing greater severity.|Baseline (Day 1), Day 15|All randomized participants who received at least 1 dose of investigational product and had TSS assessment at Day 15.|||units on a scale||Standard Error|Mean
2534716|NCT03233438|Secondary|Healthcare Costs|Cost of hospital inpatient stays, ED visits, healthcare visits, procedures, and biological tests|44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.|||USD||Standard Deviation|Mean
2534717|NCT03233438|Secondary|Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire|The SF-12 yields a physical and a mental health component summary score (referred to as physical component summary score [PCS] and mental component summary score [MCS]). The PCS and MCS follow a t-score distribution, i.e. mean of 50 and standard deviation of 10 in the general US population, meaning all scores above or below 50 are above and below the average, respectively, in the US general population.|Day 14|FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 42 and 34 patients completed all survey questions in the usual care group and new critical pathway group, respectively.|||score on a scale||Standard Deviation|Mean
2534718|NCT03233438|Secondary|Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire||Day 10-14|FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively.14 and 9 patients completed all survey questions in the usual care group and new critical pathway group, respectively. 17 and 20 patients were employed.|||Percentage||Standard Deviation|Mean
2534719|NCT03233438|Secondary|Patient Satisfaction With Care: Find Value in a Physician|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|14 Days|FAS Population. 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all survey questions in the usual care group & new critical pathway group; 43 & 34 patients answered this survey question in the usual care group & new critical pathway group, respectively.|||Participants|||Count of Participants
2534720|NCT03233438|Secondary|Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|14 Days|FAS Population. 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all survey questions in the usual care group & new critical pathway group; 41 & 34 patients answered this survey question in the usual care group & new critical pathway group, respectively.|||Participants|||Count of Participants
2534721|NCT03233438|Secondary|Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|14 Days|FAS Population. 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all survey questions in the usual care group & new critical pathway group; 43 & 34 patients answered this survey question in the usual care group & new critical pathway group, respectively.|||Participants|||Count of Participants
2534738|NCT03233438|Secondary|Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy||44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.|||Participants|||Count of Participants
2534722|NCT03233438|Secondary|Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV|Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.|14 Days|FAS Population. 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all survey questions in the usual care group & new critical pathway group; 43 & 33 patients answered this survey question in the usual care group & new critical pathway group, respectively.|||scores on a scale||Standard Deviation|Mean
2534723|NCT03233438|Secondary|Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day|Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.|14 Days|FAS Population. 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all survey questions in the usual care group & new critical pathway group; 43 & 33 patients answered this survey question in the usual care group & new critical pathway group, respectively.|||scores on a scale||Standard Deviation|Mean
2534724|NCT03233438|Secondary|Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|14 Days|FAS Population. 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all survey questions in the usual care group & new critical pathway group; 42 & 33 patients answered this survey question in the usual care group & new critical pathway group, respectively.|||Participants|||Count of Participants
2534725|NCT03233438|Secondary|Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|14 Days|FAS Population. 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all survey questions in the usual care group & new critical pathway group; 42 & 33 patients answered this survey question in the usual care group & new critical pathway group, respectively.|||Participants|||Count of Participants
2534726|NCT03233438|Secondary|Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|14 Days|43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all questions in the usual care group & new critical pathway group; 43 & 33 patients answered this question in the usual care group & new critical pathway group, respectively. Patients may have checked multiple responses.|||Participants|||Number
2534727|NCT03233438|Secondary|Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|14 Days|43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all questions in the usual care group & new critical pathway group; 43 & 33 patients answered this question in the usual care group & new critical pathway group, respectively. Patients may have checked multiple responses.|||Participants|||Number
2534728|NCT03233438|Secondary|Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy|Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.|14 Days|FAS Population. 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all survey questions in the usual care group & new critical pathway group; 43 & 33 patients answered this survey question in the usual care group & new critical pathway group, respectively.|||scores on a scale||Standard Deviation|Mean
2534729|NCT03233438|Secondary|Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|14 Days|FAS Population. 43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all survey questions in the usual care group & new critical pathway group; 43 & 33 patients answered this survey question in the usual care group & new critical pathway group, respectively.|||Participants|||Count of Participants
2534730|NCT03233438|Secondary|Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|14 Days|43 & 34 patients provided any survey data in the usual care group & new critical pathway group; 40 & 32 patients completed all questions in the usual care group & new critical pathway group; 42 & 34 patients answered this question in the usual care group & new critical pathway group, respectively. Patients may have checked multiple responses.|||Participants|||Number
2534731|NCT03233438|Secondary|Patient Satisfaction With Care: Satisfaction With Hospital Stay|Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.|14 Days|FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively.|||scores on a scale||Standard Deviation|Mean
2534732|NCT03233438|Secondary|Patient Satisfaction With Care: Hospitalization|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|14 Days|FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively.|||Participants|||Count of Participants
2534733|NCT03233438|Secondary|Patient Satisfaction With Care: Wait in Emergency Room|Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.|14 Days|FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively.|||scores on a scale||Standard Deviation|Mean
2534734|NCT03233438|Secondary|Patient Satisfaction With Care: Overall Health|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|14 Days|FAS population. 43 and 34 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 40 and 32 patients completed all survey questions in the usual care group and new critical pathway group, respectively.|||Participants|||Count of Participants
2534741|NCT03233438|Secondary|Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital||Follow-up: 30 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.|||Participants|||Count of Participants
2534742|NCT03233438|Secondary|Number of Participants With Infection-related Hospitalizations That Resulted in Admission to Intensive Care Unit||44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.|||Participants|||Count of Participants
2534743|NCT03233438|Secondary|Number of Participants With Infection-related Hospitalizations||44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.|||Participants|||Count of Participants
2534744|NCT03233438|Secondary|Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time||44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.|||Participants|||Count of Participants
2534745|NCT03233438|Secondary|Number of Total Admitted Hospital Days||44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.|||Days||Standard Deviation|Mean
2534746|NCT03233438|Primary|Number of Infection-related Total Admitted Hospital Days||44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.|||Days||Standard Deviation|Mean
2534747|NCT03233308|Secondary|Mean Percent Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)|Mean diurnal change from baseline in mean diurnal IOP measured using a Pneumatonometer and mean diurnal EVP using a custom-modified slit-lamp mounted venomanometer. (EVP conducted at a single site in only 9 participants)|Study treatment was administered for 7 days, and outcome measures collected on Day 8|Modified intent-to-treat (mITT) population, EVP analyzed in 9 participants|||percentage change||Standard Deviation|Mean
2534748|NCT03233308|Secondary|Mean Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)|Mean diurnal change from baseline in mean diurnal IOP measured using a Pneumatonometer and mean diurnal EVP using a custom-modified slit-lamp mounted venomanometer. (EVP conducted at a single site in only 9 participants)|Study treatment was administered for 7 days, and outcome measures collected on Day 8|Modified intent-to-treat (mITT) population, EVP analyzed in 9 participants|||mmHg||Standard Deviation|Mean
2534749|NCT03233308|Primary|Mean Percent Change From Baseline in the Mean Diurnal Trabecular Outflow Facility.|Mean diurnal change from baseline in trabecular (tonographic) outflow facility.|Study treatment was administered for 7 days, and outcome measures collected on Day 8|Modified intent-to-treat (mITT) population|||percentage change||Standard Deviation|Mean
2534750|NCT03233308|Primary|Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility|Mean diurnal change from baseline in trabecular (tonographic) outflow facility.|Study treatment was administered for 7 days, and outcome measures collected on Day 8|Modified intent-to-treat (mITT) population|||mcl/min/mmHg||Standard Deviation|Mean
2534751|NCT03233217|Secondary|Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD|Anti-influenza antibodies were measured by using the HAI assay for the strains A1, A1-like, A2, A2-like, B1, B2, and B2-like. Seroprotection was defined as a HAI titer >=40 (1/dilution) at Day 0 and Day 28.|Day 0 (pre-vaccination) and Day 28 (post-vaccination)|Analyzed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Here, 'number analyzed' = participants with available data for each category. Data for this outcome measure was not planned to be analyzed for Cohort 1.|||percentage of participants||95% Confidence Interval|Number
2534752|NCT03233217|Secondary|Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD|Anti-influenza antibodies were measured by using the HAI assay for the strains A1, A1-like, A2, A2-like, B1, B2, and B2-like. Seroconversion was defined as either a HAI titer lesser than (<) 10 (1/dilution) at Day 0 and post-vaccination titer greater than or equal to (>=) 40 (1/dilution) at Day 28, or HAI titer >=10 (1/dilution) at Day 0 and a >=4-fold increase in HAI titer (1/dilution) at Day 28.|Day 28 (post-vaccination)|Analyzed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Here, ‘number analyzed’ = participants with available data for each category. Data for this outcome measure was not planned to be analyzed for Cohort 1.|||percentage of participants||95% Confidence Interval|Number
2534753|NCT03233217|Secondary|Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD|GMT of anti-influenza antibodies strains (A1, A1-like, A2, A2-like, B1, B2, B2-like) were measured using an HAI assay. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.|Day 0 (pre-vaccination) and Day 28 (post-vaccination)|The analysis was performed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Data for this outcome measure was not planned to be analyzed for Cohort 1.|||ratio||95% Confidence Interval|Geometric Mean
2534754|NCT03233217|Secondary|Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD|GMT of anti-influenza antibodies strains (A1, A1-like, A2, A2-like, B1, B2, B2-like) were measured using a hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 28 (post-vaccination)|Analyzed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Here, 'number analyzed’ = participants with available data for each category. Data for this outcome measure was not planned to be analyzed for Cohort 1.|||titers (1/dilution)||95% Confidence Interval|Geometric Mean
2534933|NCT03227692|Primary|Alignment Accuracy of the Knee Tibial Components in Coronal Plain|Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.|Postoperative 6 months|Patients who have CT data at 6 month after surgery were included in the analysis.|||Participants|||Count of Participants
2534755|NCT03233217|Primary|Number of Participant With Serious Adverse Events (SAEs) After Vaccination|An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Up to 6 months after vaccination|The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).|||Participants|||Count of Participants
2534756|NCT03233217|Primary|Number of Participants With Unsolicited Adverse Events After Vaccination|An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.|Within 28 days after vaccination|The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).|||Participants|||Count of Participants
2534757|NCT03233217|Primary|Number of Participants With Solicited Injection Site and Systemic Reactions|A solicited reaction was an adverse reaction observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions: pain, erythema, swelling, induration, and bruising. Solicited systemic reactions: fever, headache, malaise, myalgia, and shivering.|Within 7 days after vaccination|The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population for Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).|||Participants|||Count of Participants
2534758|NCT03233217|Primary|Number of Participants With Immediate Unsolicited Adverse Events (AE) After Vaccination|An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.|Within 30 minutes after vaccination|The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).|||Participants|||Count of Participants
2534759|NCT03233009|Secondary|Number of Participants With Combined Skin Irritation (Dermal Response) Scores at 30 Minutes, 24 Hours and 48 Hours Post Patch Removal|A trained assessor assessed all patch sites.Following scores were used to express response observed at time of examination:0=No evidence of irritation,1=Minimal erythema;barely perceptible,2=Definite erythema,readily visible;or minimal edema; or minimal papular response,3=Erythema and papules,4=Definite edema,5=Erythema, edema,and papules,6=Vesicular eruption,7=Strong reaction spreading beyond test site.Other features indicative irritation (Superficial irritation) scores were:GradeA/Score0=Slight glazed appearance,GradeB/Score1=Marked glazing,GradeC/Score2=Glazing with peeling and cracking,GradeF/Score3=Glazing with fissures,Grade G/Score 3=Film of dried serous exudate covering all or portion of patch,Grade H/Score3=Small petechial erosions and/or scabs.The letter grades were converted to scores.Superficial irritation scores were only provided if there was a dermal response score >0.No effect is 0 score(i.e. no evidence).Full Range 0-10.Lower score indicates better product tolerabily|At Day 2 (15-30 minutes), Day 3 (24 hours) and Day 4 (48 hours) post patch removal|The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Participants|||Count of Participants
2534760|NCT03233009|Primary|Average Dermal Response Score at 48 Hours Post Patch Removal|Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.|At Day 4 (48 hours post patch removal)|The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2534761|NCT03233009|Primary|Average Dermal Response Score at 24 Hours Post Patch Removal|Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.|At Day 3 (24 hours post patch removal)|The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on Scale||Standard Deviation|Mean
2534806|NCT03231943|Secondary|Part 2: Tmax, Tlag of GSK3640254 on Day 1|Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.|Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12 hours post-dose on Day 1|PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.|||Hour||Full Range|Median
2534762|NCT03233009|Primary|Average Dermal Response Score at 30 Minutes Post Patch Removal|Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.|At Day 2 (15-30 minutes post patch removal)|The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on Scale||Standard Deviation|Mean
2534763|NCT03233009|Primary|Frequency of Dermal Response Score at 48 Hours Post Patch Removal|Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 48 hours following patch removal on Day 4 post 72 hours of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.|At Day 4 (48 hours post patch removal)|The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Participants|||Count of Participants
2534764|NCT03233009|Primary|Frequency of Dermal Response Score at 24 Hours Post Patch Removal|Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 24 hours following patch removal on Day 3 post 48 hrs of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.|At Day 3 (24 hours post patch removal)|The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Participants|||Count of Participants
2534765|NCT03233009|Primary|Frequency of Dermal Response Score at 15-30 Minutes Post Patch Removal|Product tolerability was assessed by Dermal Response Score. Test sites were evaluated 15-30 minutes following patch removal on Day 2 post 24 hrs of patch application. Response score from 0 to 7; 0= No evidence of irritation, 1= Minimal erythema, barely perceptible, 2= Definite erythema, readily visible; minimal edema or minimal papular response, 3= Erythema and papules, 4= Definite edema, 5= Erythema, edema and papules, 6= Vesicular eruption, 7= Strong reaction spreading beyond test site.|At Day 2 (15-30 minutes post patch removal)|The ITT (N= 39) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Participants|||Count of Participants
2534766|NCT03232983|Secondary|Total Amount of Glucose Infused (Gtot) Over Duration of the Clamp Procedure|Glucodynamics: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure. During the euglycemic clamp procedure, blood glucose concentrations are held constant after the administration of LY900014 by adjusting the exogenous glucose infusion rate.|Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 120 to 480 minutes and every 10 minutes for 480 to 600 minutes post-dose|All participants who have received at least one dose of study drug administered and have completed at least one clamp procedure. The IV treatment arm was needed only for PK as it served as the reference to determine the absolute bioavailability.|||milligram per kilogram (mg/kg)||Geometric Coefficient of Variation|Geometric Least Squares Mean
2534767|NCT03232983|Primary|Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) Following LY900014 Administration|Pharmacokinetics(PK): Insulin lispro AUC from time zero to 10 hours post dose [AUC(0-10h)].|Day 1: Pre-dose, 2.5, 5, 10, 15, 20, 25, 30, 40, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose|All participants who have received at least one dose of study drug and have measurable insulin lispro concentrations and evaluable PK data.|||picomole * hour/Liter (pmol * hr/L)||Geometric Coefficient of Variation|Geometric Mean
2534768|NCT03232892|Secondary|Overall Survival (OS)|OS will be calculated as 1+ the number of days from the first dose of study drugs to death due to any cause over a period of 1 year. The Kaplan-Meier analysis will be used to calculate the median OS with 95% confidence interval.|Up to 1 year|The single participant did not allow for a sufficient data collection of endpoint analysis||||||
2534769|NCT03232892|Secondary|Progression Free Survival (PFS) According to RECIST Version 1.1 Criteria.|PFS will be calculated as 1+ the number of days from the first dose of study drugs to documented radiographic progression or death due to any cause over a period of 1 year. For patients who continue treatment post-progression, the date of radiographic progression will be used for PFS analysis. For patients who continue treatment post-progression, the date of radiographic progression will be used for PFS analysis. The Kaplan-Meier analysis will be used to calculate the median PFS with 95% confidence interval.|Up to 1 year|The single participant did not allow for a sufficient data collection of endpoint analysis||||||
2534770|NCT03232892|Secondary|Disease Control Rate (DCR) According to RECIST Version 1.1 Criteria.|DCR will be defined as the percentage of patients who have achieved CR, PR, or SD for at least 12 weeks. The DCR will be summarized using descriptive statistics (N, mean, standard deviation, minimum, and maximum).|Up to 4 years|The single participant did not allow for a sufficient data collection of endpoint analysis||||||
2534771|NCT03232892|Secondary|Duration of Response (DR)|The DR for Complete Response (CR) and Partial Response (PR) will be measured from the date that the best response is first recorded until the date that PD is documented. For patients who continue treatment post progression, the date of Disease Progression (PD) documentation will be used for analysis. The DR will be summarized using descriptive statistics (N, mean, standard deviation, minimum, and maximum).|Up to 4 years|The single participant did not allow for a sufficient data collection of endpoint analysis||||||
2534807|NCT03231943|Secondary|Part 2: Cmax, C24 of GSK3640254 on Day 1|Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.|Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12 hours post-dose on Day 1|PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534772|NCT03232892|Primary|Objective Response Rate (ORR)|For participants receiving at least one dose of study treatment, the ORR is defined as the best overall response recorded from the start of the treatment until disease progression or recurrence as assessed over a 1-year period from the start of treatment. The frequency and percentages of patients with a best overall response rate of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be determined. We will test the hypothesis that the ORR is greater than the null hypothesis of 10% using the Fisher's exact test.|Up to 1 year|The single participant did not allow for a sufficient data collection of endpoint analysis||||||
2534773|NCT03232827|Secondary|Levels of Smoke Inhalation Between High vs. Low Dependent WP|Waterpipe dependence for participants will be determined at baseline. Participants will complete one ad-lib puffing session at each visit. Levels of smoke inhalation will be measured throughout each ad-lib puffing session. Flavored-sweetened WP tobacco will be associated with longer and more frequent puffing resulting in the greatest overall levels of smoke inhalation (mL of smoke inhaled). Compared to high dependence users smoking unflavored WP tobacco, low dependence users will show greater declines in (H2a) puff frequency and duration resulting in lower levels of smoke inhalation|6 months|1 participant was not included in analysis due to self-withdraw. Participants who completed one or more of the individual intervention visits were included.|||Liters||Standard Error|Mean
2534774|NCT03232827|Primary|Level of Smoke Inhalation Measured by Topography Device|Participants will complete one ad-lib puffing session at each visit. Levels of smoke inhalation will be measured throughout each ad-lib puffing session. Flavored-sweetened WP tobacco will be associated with longer and more frequent puffing resulting in the greatest overall levels of smoke inhalation (mL of smoke inhaled).|6 months|1 participant was not included in analysis due to self-withdraw. Participants who completed one or more of the individual intervention visits were included.|||Liters||Standard Error|Mean
2534775|NCT03232580|Primary|99mTc-rhAnnexin V-128 Uptake Adjudication|"In order to asses 99mTc-rhAnnexin V-128 magnitude and dynamic range of uptake within areas affected by inflammation, Single-Photon Emission Computed Tomography (SPECT)/Computed Tomography (CT) scans were interpreted and graded by at least two independent experienced nuclear medicine physicians blinded from clinical data and other imagings modality results.~In case of discrepancies between the different readers, an adjudication process based on consensus was put in place in order to obtain one final outcome for each area. Adjudication results were categorized as Positive or Negative. Only descriptive analysis performed."|60 minutes and 120 minutes post investigational product adminstration||||Participants|||Count of Participants
2534776|NCT03232580|Primary|99mTc-rhAnnexin V-128 Uptake|"In order to asses 99mTc-rhAnnexin V-128 magnitude and dynamic range of uptake within areas affected by inflammation, Single-Photon Emission Computed Tomography (SPECT)/Computed Tomography (CT) scans were interpreted and graded by at least two independent experienced nuclear medicine physicians blinded from clinical data and other imagings modality results.~Uptake compared with background (e.g. physiological liver uptake) were assessed for each affected area by nuclear medicine physicians using a 4-grade scoring system (e.g. 0, none; 1, mild or present but < to background uptake; 2, moderate or = to background uptake; 3, intense or > to background uptake). Only descriptive analysis performed."|60 minutes and 120 minutes post investigational product adminstration|Only participants with a grading uptake at any given body region are included in the analysis|||Participants|||Count of Participants
2534777|NCT03232567|Secondary|Microneutralization Immune Response|Antibody level measured by microneutralization in serum|Day 1 to Day 181|All subjects in the Safety Population that received the assigned dose of the test article, have HAI assay results on Days 1 and 29 and had no major protocol deviations affecting the primary immunogenicity outcomes prior to database lock. Per Protocol primary population for immunogenicity analyses was analyzed as randomized.|||GMT||95% Confidence Interval|Geometric Mean
2534778|NCT03232567|Secondary|HAI Immune Response|Antibody level measured by hemagglutination inhibition (HAI) in serum|Day 1 to Day 181|All subjects in the Safety Population that received the assigned dose of the test article, have HAI assay results on Days 1 and 29 and had no major protocol deviations affecting the primary immunogenicity outcomes prior to database lock. Per Protocol primary population for immunogenicity analyses was analyzed as randomized.|||GMT||95% Confidence Interval|Geometric Mean
2534779|NCT03232567|Primary|Number of Treatment-Emergent Reactogenicity Events in Participants [Safety and Tolerability]|Reactogenicity: counts and percentages of subjects with 'yes' to any reactogenicity event (nasal irritation, sneezing, nasal congestion, sore throat, change in smell, change in taste, change in vision, eye pain, headache, fatigue, muscle ache, nausea, vomiting, diarrhea, chills, fever)|14-days after vaccination|All ALT-103-201 and ALT-FLZ-401 subjects who provide informed consent, are randomized, and receive at least 1 vaccination. The Safety Population will be used for all safety analyses and will be analyzed according to the treatment received.|||Participants|||Count of Participants
2534780|NCT03232567|Primary|Number of Treatment-Emergent Adverse Events in Participants [Safety and Tolerability]|Adverse events (AEs): counts and percentages of subjects with AEs Day 1 to day 29 and Medically attended AEs (MAEs), serious AEs (SAEs), new-onset chronic illnesses (NCIs) from Day 1 to Day 181|Day 1 to Day 181|All ALT-103-201 and ALT-FLZ-401 subjects who provide informed consent, are randomized, and receive at least 1 vaccination. The Safety Population will be used for all safety analyses and will be analyzed according to the treatment received.|||Participants|||Count of Participants
2534781|NCT03232333|Other Pre-specified|Short Form - 36: Bodily Pain|Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Bodily Pain which assess aspects of physical pain. The higher the score the better the subject's physical health with respect to feeling pain. Range from 0-100.|Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)|Per protocol analysis|||score on a scale||Standard Deviation|Mean
2534782|NCT03232333|Other Pre-specified|Short Form 36 - Mental Component Summary Score|Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Vitality, Role Emotional, Social Functioning, and Mental health which assess aspects of Mental health. These are used to make an overall mental health score, the Mental Component Summary score (MCS). The higher the score the better the subject's mental health. Range from 0-100.|Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)|Subjects who's wound healed in 12 weeks or less one without appropriate data|||score on a scale||Standard Deviation|Mean
2534783|NCT03232333|Other Pre-specified|Short Form F36 - Physical Component Summary Score|Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Physical Function, Role Physical, Bodily Pain, and General health which assess aspects of physical health. These are used to make an overall physical health score, the Physical Component Summary score (PCS). The higher the score the better the subject's physical health. Range from 0-100.|Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)|Subjects who's ulcer healed in 12 weeks or less two without appropriate data|||score on a scale||Standard Deviation|Mean
2534784|NCT03232333|Other Pre-specified|Change in Patient's Wound Size|Gives the mean area that the wound closed per week|12 weeks|Per protocol analysis|||cm^2 per week||Standard Deviation|Mean
2534785|NCT03232333|Other Pre-specified|Time to Closure|Measures the time from treatment to wound healing|12 weeks|Subjects who healed in 12 weeks or less|||Weeks||Full Range|Mean
2534786|NCT03232333|Other Pre-specified|MIRODERM Applications|Frequency of MIRODERM applications prior to wound closing|12 weeks|Per protocol analysis|||Applications||Full Range|Median
2534787|NCT03232333|Primary|Percentage of Participants|Percentage of participants with healed ulcers within 12 weeks of treatment|12 weeks|Per protocol analysis|||Percentage of participants with healed u|||Number
2534788|NCT03231943|Secondary|Part 2: Dose Proportionality (AUC0-24) Following Repeated Dose of GSK3640254 at Day 1|Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.|Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose|PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.|||hour*micrograms per mililiter||Geometric Coefficient of Variation|Geometric Mean
2534789|NCT03231943|Secondary|Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 at Day 1|Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.|Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose|PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534790|NCT03231943|Secondary|Part 2: Pre-dose Concentration of GSK3640254 on Day 2 to Day 14|Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. results are presented treatment wise.|Pre-dose on Days 2,3,4,6,8,10,12 and 14|PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.|||Nanogram per milliliter||Standard Deviation|Mean
2534791|NCT03231943|Secondary|Part 2: Accumulation Ratio of C(Tau) (R[CTAU]) From Day 2 to Day 15|Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The accumulation ratio was estimated by calculating the ratio of the geometric least squares (GLS) means of PK parameters between Day 15 and Day 2, and the corresponding 90% CI for each dose. Ratio and 90% confidence interval is presented. Results are presented treatment wise.|Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 15 dose|PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.|||Ratio of Ctau||90% Confidence Interval|Number
2534792|NCT03231943|Secondary|Part 2: Accumulation Ratio of Cmax (R [CMAX]) From Day 1 to Day 14|Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The accumulation ratio was estimated by calculating the ratio of the geometric least squares (GLS) means of PK parameters between Day 14 and Day 1, and the corresponding 90% CI for each dose. Ratio and 90% confidence interval is presented. Results are presented treatment wise.|Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose|PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.|||Ratio of Cmax||90% Confidence Interval|Number
2534793|NCT03231943|Secondary|Part 2: Accumulation Ratio of AUC(0-tau) (R [AUC{0-TAU}]) From Day 1 to Day 14|Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The accumulation ratio was estimated by calculating the ratio of the geometric least squares (GLS) means of PK parameters between Day 14 and Day 1, and the corresponding 90% CI for each dose. Ratio and 90% confidence interval is presented. Results are presented treatment wise.|Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose|PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.|||Ratio of AUC(0-tau)||90% Confidence Interval|Number
2534794|NCT03231943|Secondary|Part 2: Dose Proportionality (Cmax) Following Repeated Dose of GSK3640254 on Day 14|Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.|Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose|PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534805|NCT03231943|Secondary|Part 2: Tmax GSK3640254 on Day 14|Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.|Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose|PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.|||Hour||Full Range|Median
2534795|NCT03231943|Secondary|Part 2: Dose Proportionality (Ctrough) Following Repeated Dose of GSK3640254 on Day 14|Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.|Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose|PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534796|NCT03231943|Secondary|Part 2: Dose Proportionality (AUC0-tau) Following Repeated Dose of GSK3640254 on Day 14|Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.|Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose|PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.|||hour*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534797|NCT03231943|Secondary|Part 1: Dose Proportionality for Cmax Following Single Dose of GSK3640254 on Day 1|Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.|Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose|PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.|||Micrograms per mililiter||95% Confidence Interval|Geometric Mean
2534798|NCT03231943|Secondary|Part 1: Dose Proportionality (AUC0-24) Following Single Dose of GSK3640254 on Day 1|Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.|Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24 hours post dose|PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.|||hour*micrograms per mililiter||95% Confidence Interval|Geometric Mean
2534799|NCT03231943|Secondary|Part 1: Dose Proportionality (AUC[0-inf]) Following Single Dose of GSK3640254 on Day 1|Blood samples were collected at indicated time points and PK analysis was performed. Dose proportionality was assessed using the power model. Results are presented treatment wise.|Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours post dose|PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.|||hour*micrograms per mililiter||95% Confidence Interval|Geometric Mean
2534800|NCT03231943|Secondary|Part 2: CL/F of GSK3640254: Day 14|Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.|Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose|PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.|||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
2534801|NCT03231943|Secondary|Part 2: T1/2 of GSK3640254: Day 14|Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.|Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose|PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.|||Hour||Geometric Coefficient of Variation|Geometric Mean
2534802|NCT03231943|Secondary|Part 2: Plasma Trough Concentration (Ctau) of GSK3640254: Day 14|Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The PK parameter name for Part 2 (Day 14) trough concentration was changed using Phoenix WinNonlin 8 from Ct to Ctrough. Day 15 Ctrough values were used for dose proportionality and time to steady-state assessments.|Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose|PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.|||micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534803|NCT03231943|Secondary|Part 2: AUC From Pre-dose to the End of the Dosing Interval at Steady State (AUC[0-tau]): Day 14|Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.|Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24 hours after Day 14 dose|PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.|||hour* micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534804|NCT03231943|Secondary|Part 2: Cmax of GSK3640254 on Day 14|Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.|Pre-dose and 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72 and 96 hours after Day 14 dose|PK Population, The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2. Only those participants with data available at the specified data points were analyzed.|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534892|NCT03228433|Primary|Number of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose||Baseline Up to Day 184|The safety analysis set included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
2534808|NCT03231943|Secondary|Part 2: AUC(0-24) of GSK3640254: Day 1|Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.|Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12 and 24 hours post-dose on Day 1|PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the repeat dose phase of the study Part 2.|||Hour*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2534809|NCT03231943|Secondary|Part 1: Time of Occurrence of Cmax (Tmax), Lag Time (Tlag), and Time to Reach Clast (Tlast) of GSK3640254|Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.|Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose|PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.|||Hour||Full Range|Median
2534810|NCT03231943|Secondary|Part 1: Maximum Observed Concentration (Cmax), Concentration of GSK3640254 at 24 Hours (C24) and Last Quantifiable Concentration (Clast) of GSK3640254|Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.|Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose|PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.|||Micrograms per milliliter||95% Confidence Interval|Geometric Mean
2534811|NCT03231943|Secondary|Part 1: Apparent Oral Clearance (CL/F) of GSK3640254|Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.|Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose|PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Liters/hour||95% Confidence Interval|Geometric Mean
2534812|NCT03231943|Secondary|Part 1: Apparent Terminal Phase Half-life (T1/2) of GSK3640254|Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Most of the concentrations were below limit of quantification (BLQ) at this dose group this value and/ or %AUC extrapolated was >20% for all participants so this value should be used with caution. Results are presented treatment wise.|Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose|PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1. Only those participants with data available at the specified data points were analyzed.|||Hour||95% Confidence Interval|Geometric Mean
2534813|NCT03231943|Secondary|Part 1: AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3640254|Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.|Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose|PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1. Only those participants with data available at the specified data points were analyzed.|||Hour*microgram per milliliter||95% Confidence Interval|Geometric Mean
2534814|NCT03231943|Secondary|Part 1: AUC From Zero to Time of Last Sample Taken (AUC[0-Tlast]) of GSK3640254|Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.|Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12, 24, 48, 72 and 96 hours post-dose|PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1.|||Hour*microgram per milliliter||95% Confidence Interval|Geometric Mean
2534815|NCT03231943|Secondary|Part 1: Area Under the Plasma Concentration Time Curve (AUC) From Zero to 24 Hour (AUC[0-24]) of GSK3640254|Blood samples were collected at indicated time points and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Results are presented treatment wise.|Pre-dose and 0.5,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24 hours post-dose|PK Population. The PK Population include all participants who undergo plasma PK sampling and have evaluable PK parameters estimated during the single dose phase of the study Part 1. Only those participants with data available at the specified data points were analyzed.|||Hour*microgram per milliliter||95% Confidence Interval|Geometric Mean
2534816|NCT03231943|Primary|Part 2: Number of Participants With Abnormal ECG Findings|12-lead ECG were obtained at given time points. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS).Results are presented treatment wise.|Day 1 (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5, 5.5, 6, 8, 12, 24 hours); Pre-dose on Days 3, 4, 6, 8, 10, 12; Day 14: Pre-dose, 1, 2, 4.5, 5, 6, 12, 24, 48, 72 and 96 hours post-dose and follow up (Day 28)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2534817|NCT03231943|Primary|Part 2: Change From Baseline in Vital Sign: Respiratory Rate|Respiratory rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12 and 14 (pre dose and 72 hours) and Follow up (Day 28)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Breaths per minute||Standard Deviation|Mean
2534893|NCT03228433|Primary|Number of Participants Who Meet the Markedly Abnormal Criteria for Neurological Assessment Measurements at Least Once Post Dose||Baseline Up to Day 184|The safety analysis set included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
2542684|NCT02994732|Primary|Pharmacokinetics of 14C-labeled BVD-523(Radioactivity in Whole Blood and Plasma) t1/2|Elimination half-life|Collected over 15 days|All enrolled subjects|||hr||Standard Deviation|Mean
2534818|NCT03231943|Primary|Part 2: Change From Baseline in Vital Sign: Temperature|Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12, and 14 (pre dose and 72 hours) and Follow up (Day 28)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Degree Celsius||Standard Deviation|Mean
2534819|NCT03231943|Primary|Part 2: Change From Baseline in Vital Sign: Pulse Rate|Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12, and 14 (pre dose and 72 hours) and Follow up (Day 28)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Beats per minute||Standard Deviation|Mean
2534820|NCT03231943|Primary|Part 2: Change From Baseline in Vital Signs: SBP and DBP|SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -1), pre dose on Days 1,2,4,6,8,10,12,and 14 (pre dose and 72 hours) and Follow up (Day 28)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2534821|NCT03231943|Primary|Part 2: Number of Participants With Abnormal Urinalysis|Urine samples were collected analyze the abnormal findings for potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick.|Up to Day 28|Safety Population|||Participants|||Count of Participants
2534822|NCT03231943|Primary|Part 2: Change From Baseline in Chemistry Parameter: Protein|Blood samples were collected to analyze the chemistry parameter: Protein. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2534823|NCT03231943|Primary|Part 2: Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin|Blood samples were collected to analyze the chemistry parameter: bilirubin, creatinine, direct bilirubin . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2534824|NCT03231943|Primary|Part 2: Change From Baseline in Chemistry Parameter: Glucose|Blood samples were collected at indicated time points to analyze the chemistry parameter: glucose . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -2), Day 8 (predose), Day 14 (48 hours) post dose and Follow up (Day 28)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2534825|NCT03231943|Primary|Part 2: Change From Baseline in Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides|Blood samples were collected at indicated time points to analyze the chemistry parameter: cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -2), Day 8 (pre dose), Day 14 (48 hours) post dose and Follow up (Day 28)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2534826|NCT03231943|Primary|Part 1: Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Magnesium, Phosphate, Potassium, Sodium, Urea|Blood samples were collected to analyze the chemistry parameter: bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, urea. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2534827|NCT03231943|Primary|Part 2: Change From Baseline in Chemistry Parameter: ALT, AST,ALP|Blood samples were collected to analyze the chemistry parameter: ALT, AST,ALP. Day -2was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day14: 48 and 96 hours post dose, Follow up (Day 28)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||International units per liter||Standard Deviation|Mean
2534828|NCT03231943|Primary|Part 2: Change From Baseline in Hematology Parameter: Hb|Blood samples were collected at indicated time points to analyze the hematology parameter: Hb. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2534894|NCT03228433|Primary|Number of Participants Who Discontinued Due to an Adverse Event (AE)||Baseline Up to Day 184|The safety analysis set included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
2542685|NCT02994732|Primary|Pharmacokinetics of 14C-labeled BVD-523(Radioactivity in Whole Blood and Plasma) Cmax|peak (maximum) concentration|Collected over 5 days|All 6 subjects enrolled|||ng/ml||Standard Deviation|Mean
2534829|NCT03231943|Primary|Part 2: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes|Blood samples were collected to analyze the hematology parameter: percentage of reticulocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||10^12 cells per liter||Standard Deviation|Mean
2534830|NCT03231943|Primary|Part 2: Change From Baseline in Hematology Parameter: Hematocrit|Blood samples were collected at indicated time points to analyze the hematology parameter: hematocrit. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Percentage of red blood cells in blood||Standard Deviation|Mean
2534831|NCT03231943|Primary|Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)|Blood samples were collected at indicated time points to analyze the hematology parameter: Erythrocyte MCH. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Picograms||Standard Deviation|Mean
2534832|NCT03231943|Primary|Part 2: Change From Baseline in Hematology Parameter: Erythrocytes MCV|Blood samples were collected at indicated time points to analyze the hematology parameters: Erythrocyte MCV. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -2), pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Femtoliter||Standard Deviation|Mean
2534833|NCT03231943|Primary|Part 2: Change From Baseline in Hematology Parameter: Erythrocytes|Blood samples were collected at indicated time points to analyze the hematology parameters: Erythrocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -2), Pre dose on Days 2,4,6,8,10,12,14 Day 14: 48 and 96 hours post dose, Follow up (Day 28)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||10^12 cells/Liter||Standard Deviation|Mean
2534834|NCT03231943|Primary|Part 2: Change From Baseline in Abnormal Hematology Findings: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.|Blood samples were collected at indicated time points to analyze the hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -2), Pre dose on Days 2,4,6,8,10,12,14 Day 14 : 48 and 96 hours post dose, Follow up (Day 28)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||10^9 cells/Liter||Standard Deviation|Mean
2534835|NCT03231943|Primary|Part 2: Number of Participants AEs and SAEs|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE. Results are presented treatment wise.|Up to Day 28|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2534836|NCT03231943|Primary|Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings|12-lead ECGs were measured in a semi-supine position using an automated ECG machine after approximately 5 minutes of rest for the participant. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS).|Baseline (Day 1 predose), 1,2,4,6,12,24,48,72,96 hours post dose and Follow up (Day 15)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2534837|NCT03231943|Primary|Part 1: Change From Baseline in Vital Sign: Respiratory Rate|Respiratory rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Breaths per minute||Standard Deviation|Mean
2534838|NCT03231943|Primary|Part 1: Change From Baseline in Vital Signs: Temperature|Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Degree Celsius||Standard Deviation|Mean
2534839|NCT03231943|Primary|Part 1: Change From Baseline in Vital Signs: Pulse Rate|Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Beats per minute||Standard Deviation|Mean
2534840|NCT03231943|Primary|Part 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -1), 1,2,4.5,6,12,24,48,72,96 hours post dose and Follow up (Day 15)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2534841|NCT03231943|Primary|Part 1: Number of Participants With Abnormal Urinalysis|Urine samples were collected at given time points to analyze the abnormal findings for potential of hydrogen (pH), glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase by dipstick.|Up to Day 15|Safety Population.|||Participants|||Count of Participants
2534842|NCT03231943|Primary|Part 1: Change From Baseline in Clinical Chemistry Parameter: Protein|Blood samples were collected to analyze the chemistry parameter: Protein. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Grams per liter||Standard Deviation|Mean
2534843|NCT03231943|Primary|Part 1: Change From Baseline in Clinical Chemistry Parameter: Bilirubin, Creatinine, Direct Bilirubin|Blood samples were collected to analyze the chemistry parameter: bilirubin, creatinine, direct bilirubin . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Grams per liter||Standard Deviation|Mean
2534844|NCT03231943|Primary|Part 1: Change From Baseline in Chemistry Parameter: Glucose|Blood samples were collected to analyze the chemistry parameter: glucose . Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -2) and Day 1 (96 hours) and Follow up (Day 15)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2534845|NCT03231943|Primary|Part 1: Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Cholesterol (LDL) Cholesterol, Triglycerides|Blood samples were collected to analyze the chemistry parameter: cholesterol, glucose, HDL cholesterol, LDL cholesterol, triglycerides. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -2) and Day 1 (96 hours) and Follow up (Day 15)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2534846|NCT03231943|Primary|Part 1: Change From Baseline in Clinical Chemistry Parameters : Bicarbonate, Calcium, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea|Blood samples were collected to analyze the chemistry parameter: bicarbonate, calcium, chloride, magnesium, phosphate, potassium, sodium, urea. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2534847|NCT03231943|Primary|Part 1: Change From Baseline in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphate (ALP)|Blood samples were collected to analyze the chemistry parameter: ALT, AST, and ALP. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||International units per liter||Standard Deviation|Mean
2534848|NCT03231943|Primary|Part 1: Change From Baseline in Hematology Parameter: Hemoglobin (Hb)|Blood samples were collected to analyze the hematology parameter: Hb. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Grams per liter||Standard Deviation|Mean
2534849|NCT03231943|Primary|Part 1: Change From Baseline in Hematology Parameter: Percentage of Reticulocytes|Blood samples were collected to analyze the hematology parameter: percentage of reticulocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||10^12 cells per liter||Standard Deviation|Mean
2534850|NCT03231943|Primary|Part 1: Change From Baseline in Hematology Parameter: Hematocrit|Blood samples were collected to analyze the hematology parameter: hematocrit. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percentage of red blood cells in blood||Standard Deviation|Mean
2534895|NCT03228433|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)||Baseline Up to Day 184|The safety analysis set included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
2539485|NCT03070730|Secondary|Change in Physical Functioning-FSS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Fatigue Severity Scale.|1 week after third intervention|||||||
2534851|NCT03231943|Primary|Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin (Erythrocyte MCH)|Blood samples were collected to analyze the hematology parameter: Erythrocyte MCH. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.Results are presented treatment wise.|Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Picograms||Standard Deviation|Mean
2534852|NCT03231943|Primary|Part 1: Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Volume (Erythrocyte MCV).|Blood samples were collected to analyze the hematology parameters: erythrocyte MCV. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Femtoliter||Standard Deviation|Mean
2534853|NCT03231943|Primary|Part 1: Change From Baseline in Hematology Parameters: Erythrocytes.|Blood samples were collected to analyze the hematology parameters: erythrocytes. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.Results are presented treatment wise.|Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||10^12 cells/Liter||Standard Deviation|Mean
2534854|NCT03231943|Primary|Part 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets.|Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Day -2 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Results are presented treatment wise.|Baseline (Day -2), 24 hours, 48 hours, 96 hours and Follow up (Day 15)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||10^9 cells /Liter||Standard Deviation|Mean
2534855|NCT03231943|Primary|Part 1:Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)|An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE. Results are presented treatment wise.|Up to Day 15|Safety Population. It is comprised of all participants who received at least one dose of a study treatment.|||Participants|||Count of Participants
2534856|NCT03231917|Secondary|Adenoma < 6mm Detection Rate|Adenoma-level miss rates will be calculated as the number of additional adenomas < 6 mm detected during the second examination divided by the total number of adenomas< 6 mm detected during both examinations.|1 hour or the duration of the procedure|Adenomas < 6 mm|||Adenomas < 6 mm|Adenomas < 6 mm||Count of Units
2534857|NCT03231917|Secondary|Patient-level Miss Rate|Patient-level miss rates will be calculated as the number of patients with one or more adenomas detected during the second examination, divided by the total number of patients with at least one adenoma in either examination|1 hour or the duration of the procedure||||Participants|||Count of Participants
2534858|NCT03231917|Primary|Adenoma Miss Rate|Adenoma-level miss rates will be calculated as the number of additional adenomas detected during the second examination divided by the total number of adenomas detected during both examinations|Through procedure, an average of 1 hr|Adenoma miss rate|||adenomas missed by first exam|adenomas||Number
2534859|NCT03231709|Secondary|Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (A-T Administered Group)|Participants answered standardized questions about their preference of drug therapy for Type 2 Diabetes Mellitus. The preference of drug therapy was categorized by background factors like age (years), gender, height (cm), weight (kg), BMI (kg/m^2), duration of diabetes (years), work status, alcohol intake history, smoking habits, experience of educational hospitalization on DM, presence of cohabiter, percentage of compliance with DPP-4 inhibitors during 4-weeks before the start of treatment period, number of oral drugs per day at the beginning of treatment period (excluding investigational drug), complication of metabolic syndrome, percentage of HbA1c (NGSP is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at the time of informed consent.|At Week 16|FAS included all enrolled participants who received either the investigational product or comparator at least once during the study after randomization.|||Participants|||Count of Participants
2534860|NCT03231709|Secondary|Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors (T-A Administered Group)|Participants answered standardized questions about their preference of drug therapy for Type 2 Diabetes Mellitus. The preference of drug therapy was categorized by background factors like age (years), gender, height (cm), weight (kg), BMI (kg/m^2), duration of diabetes (years), work status, alcohol intake history, smoking habits, experience of educational hospitalization on DM, presence of cohabiter, percentage of compliance with DPP-4 inhibitors during 4-weeks before the start of treatment period, number of oral drugs per day at the beginning of treatment period (excluding investigational drug), complication of metabolic syndrome, percentage of HbA1c (NGSP is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at the time of informed consent.|At Week 16|FAS included all enrolled participants who received either the investigational product or comparator at least once during the study after randomization.|||Participants|||Count of Participants
2534909|NCT03227861|Secondary|Percentage of Participants With Treatment Adherence >95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48|Percentage of participants with treatment adherence >95% based on pill count at Weeks 4, 8, 12, 24, 36, and 48 were reported. Treatment adherence was defined as having a treatment adherence of greater than (>) 95 percent (%) by pill count.|Weeks 4, 8, 12, 24, 36, and 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints.|||Percentage of participants|||Number
2534861|NCT03231709|Secondary|Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period by Background Factors|Participants answered standardized questions about their preference of drug therapy for Type 2 Diabetes Mellitus. The preference of drug therapy was categorized by background factors like age (years), gender, height (cm), weight (kg), BMI (kg/m^2), duration of diabetes (years), work status, alcohol intake history, smoking habits, experience of educational hospitalization on DM, presence of cohabiter, percentage of compliance with DPP-4 inhibitors during 4-weeks before the start of treatment period, number of oral drugs per day at the beginning of treatment period (excluding investigational drug), complication of metabolic syndrome, percentage of HbA1c (NGSP is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at the time of informed consent.|At Week 16|FAS included all enrolled participants who received either the investigational product or comparator at least once during the study after randomization.|||Participants|||Count of Participants
2534862|NCT03231709|Primary|Number of Participants by Their Treatment Preference Using Standardized Questions at the End of Treatment Period|Participants answered standardized questions about their preference of drug therapy for Type 2 Diabetes Mellitus. Participants selected one choice from the following 4 choices; either once-weekly DPP-4 inhibitor or daily DPP-4 inhibitor, once-weekly DPP-4 inhibitor, daily DPP-4 inhibitor, neither once-weekly DPP-4 inhibitor nor daily DPP-4 inhibitor. Reported data was the number of participants with a choice of either trelagliptin (once-weekly DPP-4 inhibitor) or alogliptin (once-daily DPP-4 inhibitor), trelagliptin, alogliptin, neither trelagliptin nor alogliptin.|At Week 16|FAS included all enrolled participants who received either the investigational product or comparator at least once during the study after randomization.|||Participants|||Count of Participants
2534863|NCT03231371|Secondary|Gadolinium Enhancement by Cardiac MRI|Categorical measure - yes or no; number of participants with gadolinium enhancement|Baseline MRI only|Only 9 participants had MRI data available. Remaining subjects (of 21) did not undergo MRI performed within study time frame.|||Participants|||Count of Participants
2534864|NCT03231371|Primary|Coronary Flow Reserve (CFR)|Ratio of peak to baseline coronary flow velocity (CFV)|Baseline testing (acute only), 3 minutes of adenosine infusion|Remaining subjects (of the 21 who completed) had unusable signal data.|||ratio: peak to baseline CFV||Standard Deviation|Mean
2534865|NCT03231345|Secondary|The Median Time Required for Cannulation of the Internal Jugular Vein by an Emergency Physician.|The median time it took an Emergency Physician from needle puncture to cannulation in minutes|Less than 20 minutes||||minutes||Inter-Quartile Range|Median
2534866|NCT03231345|Secondary|Prevalence of Complications Related to Cannulation of the Internal Jugular Vein.|Percentage of Participants with successfully placed lines with a complication|24 hours||||Participants|||Count of Participants
2534867|NCT03231345|Primary|Number of Participants With Successful Cannulation of the Internal Jugular Vein|The primary study endpoint is successful cannulation vs failure to cannulate the internal jugular vein.|Less than 20 minutes||||Participants|||Count of Participants
2534868|NCT03231228|Secondary|Cefazolin Plasma Concentration Following Infusion|Concentrations will be determined through analysis of 4 blood samples drawn at up to 4 hours after the start of study drug infusion.|Up to 4 hours after start of study drug infusion||||mcg/mL||Standard Deviation|Mean
2534869|NCT03231228|Primary|Incidence of Treatment-Emergent Adverse Events [Safety]|Safety will be assessed by monitoring adverse events (AEs), physical examinations, vital signs, ECGs, and clinical laboratory results.|8 days||||Participants|||Count of Participants
2534870|NCT03230864|Secondary|Response|Response is defined as a ≥20% reduction in PANSS total score from Randomization|at Week 8|Only patients randomized to receive double-blind treatment in the DBT period are analyzed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm. Overall Number of Participants Analysed is number of patients in the FAS with a week 8 observation|||Participants|||Count of Participants
2534871|NCT03230864|Secondary|Change From Randomization to Week 8 in PANSS Marder Negative Factor Score|The PANSS Negative Factor score is a subset of the PANSS assessing negative symptoms of schizophrenia. The factor consist of the seven items: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity, motor retardation, and active social avoidance which are each rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Negative Factor score (7 items) range from 7 to 49 with a higher score indicating greater severity of symptoms.|From Randomization to Week 8|Only patients randomized to receive double-blind treatment in the DBT period are analyzed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm. Overall Number of Participants Analysed is number of patients in the FAS with a week 8 observation|||units on a scale||Standard Error|Mean
2534872|NCT03230864|Secondary|Change From Randomization to Week 8 in 16-item Negative Symptom Assessment (NSA-16 Total) Score|The NSA-16 is a clinician-rated scale designed to assess the presence, severity, and range of negative symptoms associated with schizophrenia. The NSA-16 consists of 16 items arranged in 5 subdomains: communication dysfunction (items 1 to 4), emotional/affective dysfunction (items 5 to 7), dysfunction in sociality (items 8 to 10), motivational/hedonic dysfunction (items 11 to 14), and reduced psychomotor activity (items 15 and 16), and a Global Negative Symptom Rating. NSA-16 items are rated on a 6-point scale from 1 (behaviour is normal) to 6 (behaviour severely reduced), and a score of 9 if the item is not-rateable. The Global Negative Symptom Rating is rated from 1 (no evidence of symptoms) to 7 (extremely severe symptoms). The 16 items are summed to yield a total score ranging from 16 to 96 and the global rating ranges from 1 to 7.|From Randomization to Week 8|Only patients randomized to receive double-blind treatment in the DBT period are analyzed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm. Overall Number of Participants Analysed is number of patients in the FAS with a week 8 observation|||units on a scale||Standard Error|Mean
2534896|NCT03228212|Secondary|Overall Handling|Overall Handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average handling score from the 3 study periods was reported.|2-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||Units on a Scale||Standard Deviation|Mean
2534873|NCT03230864|Secondary|Change From Randomization to Week 8 in Global Clinical Impression - Severity of Illness (CGI-S) Score|CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate worsening|From Randomization to Week 8|Only patients randomized to receive double-blind treatment in the DBT period are analyzed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm. Overall Number of Participants Analysed is number of patients in the FAS with a week 8 observation|||units on a scale||Standard Error|Mean
2534874|NCT03230864|Primary|Change From Randomization to Week 8 in Positive and Negative Syndrome Scale (PANSS) Total Score|PANSS total score administered by the investigator. It included a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A negative score indicates an improvement compared to Randomization.|From Randomization to Week 8|Only patients randomized to receive double-blind treatment in the DBT period are analyzed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm. Overall Number of Participants Analysed is number of patients in the full-analysis set (FAS) with a week 8 observation|||units on a scale||Standard Error|Mean
2534875|NCT03229486|Secondary|Time Recovery of TOF Ratio to 0.9|Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.9|Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.9, assessed up to 60 minutes||||seconds||Standard Deviation|Mean
2534876|NCT03229486|Secondary|Time Recovery of TOF Ratio to 0.8|Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.8|Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.8, assessed up to 60 minutes||||seconds||Standard Deviation|Mean
2534877|NCT03229486|Secondary|Time to Extubation|time from administration of reversal agent to time of tracheal extubation|time from administration of reversal agent to time of tracheal extubation, assessed up to 60 minutes||||seconds||Standard Deviation|Mean
2534878|NCT03229486|Secondary|Time to Awakening|time from administration of reversal agent to time of eye opening or child showing purposeful movement|time from administration of reversal agent to time of eye opening or child showing purposeful movements, assessed up to 60 minutes||||seconds||Standard Deviation|Mean
2534879|NCT03229486|Secondary|Time to Regular Breathing|time from administration of reversal agent to time of deep, regular breathing|time from administration of reversal agent to time of deep, regular breathing, assessed up to 60 minutes||||seconds||Standard Deviation|Mean
2534880|NCT03229486|Secondary|Time Recovery of TOF Ratio to 0.7|Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.7|Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.7, assessed up to 60 minutes||||seconds||Standard Deviation|Mean
2534881|NCT03229486|Primary|Pediatric Anesthesia Emergence Delirium Score|Maximum Pediatric Anesthesia Emergence Delirium (PAED) score after arrival in the PACU.Higher values represent more emergence delirium (worse) PAED Score is represented with total PAED score summed up of subscales. The total score is reported and it ranges from 0 to 20. Higher score means worse state.|within 30 minutes after arrival at post-anesthesia care unit (PACU)||||units on a scale||Full Range|Median
2534882|NCT03229252|Secondary|Change From Baseline Through Day 28 in Clinical Laboratory Tests|Chemistry, Hematology, Urinalysis|Day 1 through Day 28||||Participants|||Count of Participants
2534883|NCT03229252|Secondary|Number of Participants With Adverse Events||Day 1 through Day 28||||Participants|||Count of Participants
2534884|NCT03229252|Primary|Change in Percent Predicted FEV1||Baseline and Day 28||||change from baseline in ppFEV1||Standard Deviation|Mean
2534885|NCT03229109|Primary|Number of Measurements Grouped by Level or Error|Number of measurements obtained with Dehydration Monitor with errors greater/less than 20% (as compared to Shekel B-200-P)|90 minutes||||Number of measurements|||Number
2534886|NCT03228433|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-418F|The pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least one measurable plasma concentration or amount of drug in urine for TAK-418-F.|Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose||||hour||Full Range|Median
2534887|NCT03228433|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-418F||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least one measurable plasma concentration or amount of drug in urine for TAK-418-F.|||nanogram per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2534888|NCT03228433|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-418F||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least one measurable plasma concentration or amount of drug in urine for TAK-418-F.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2534889|NCT03228433|Secondary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-418F (TAK-418 Free Base)||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least one measurable plasma concentration or amount of drug in urine for TAK-418-F.|||hour nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2534890|NCT03228433|Primary|Number of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose||Baseline Up to Day 14||||participants|||Number
2534891|NCT03228433|Primary|Number of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose||Baseline Up to day 184|The safety analysis set included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
2534988|NCT03224390|Primary|Number of Participants Who Report Starting Any Modern Method of Contraception Since the Start of the Study|Woman reports starting any modern method of contraception since the start of the study|4-months post-encouragement||||Participants|||Count of Participants
2534897|NCT03228212|Secondary|Overall Quality of Vision|Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average vision score from the 3 study periods was reported.|2-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||Units on a Scale||Standard Deviation|Mean
2534898|NCT03228212|Primary|Number of Grade 3 or Higher Slit Lamp Findings|Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by lens was reported.|Up to 2-Week Follow-up|Subjects that were dispensed at least one study lens.|||Slit Lamp Finding|Eyes||Number
2534899|NCT03228212|Primary|Contact Lens Fitting Acceptance Rate|Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens. The lens fit acceptance rate for both post lens fitting at the 2-week follow-up was reported for each lens type.|Up to 2-Week Follow-up|Subjects that completed all study visits.|||proportion of eyes|eyes||Number
2534900|NCT03228212|Primary|Distance Monocular LogMAR Visual Acuity|Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart at the 2-week follow-up for each subject eye during each of the three study periods. The average visual acuity for each lens type from the 3 study periods was reported.|2-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||logMAR|Eyes|Standard Deviation|Mean
2534901|NCT03228212|Primary|Overall Comfort|Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average comfort score from the 3 study periods was reported.|2-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||Units on a Scale||Standard Deviation|Mean
2534902|NCT03227861|Secondary|Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU])|Median medical costs of care (United States of America [USA] dollars) based on healthcare resource utilization [HRU]) were reported. The cost of care specified for overnight hospitalization, hospital day care ward (without overnight), emergency room visit, general practitioner visit, specialist visit, nurse practitioner visit, physician assistant visit and Other visit.|Up to Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies those participants who were evaluable for the specified categories.|||USA dollars||Full Range|Median
2534903|NCT03227861|Secondary|Number of Participants With Emergency Room Visits|Number of participants with emergency room visits was reported.|Up to Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.|||Participants|||Count of Participants
2534904|NCT03227861|Secondary|Number of Participants With Outpatient Visits|Number of participants with outpatient visits (in addition to study visits, including General practitioner visit, Specialist visit, Nurse practitioner visit, Physician assistant visit, Home healthcare nurse visit and Other visit) was reported.|Up to Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.|||Participants|||Count of Participants
2534905|NCT03227861|Secondary|Duration of Hospitalizations|Duration of hospitalizations in days was reported for those participants hospitalized during the course of the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this OM.|Up to Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.|||Days||Full Range|Median
2534906|NCT03227861|Secondary|Number of Participants With Hospitalizations|Number of participants with hospitalizations (overnight) was reported.|Up to Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.|||Participants|||Count of Participants
2534907|NCT03227861|Secondary|Mean Total Scores for the HIV-Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4, 24, and 48|The HIV treatment satisfaction questionnaire (HIVTSQ) is based on a 10-item self-reported scale that measures overall satisfaction with treatment. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6). The higher the score, the greater the treatment satisfaction.|Weeks 4, 24, and 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints.|||Units on a scale||Standard Error|Mean
2534908|NCT03227861|Secondary|Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48|Percentage of participants with 100 % adherence based on participants self-report, using a 4-Day recall at Weeks 4, 8, 12, 24, 36, and 48 was reported.|Weeks 4, 8, 12, 24, 36, and 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints.|||Percentage of participants||Standard Deviation|Mean
2535171|NCT03217968|Secondary|Pain Relief (PR) at 2 Hours|The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to a mild headache or to no headache (Grade 1 or 0) at 2 hours after the beginning of the e-TNS session.|2 hours||||Participants|||Count of Participants
2534910|NCT03227861|Secondary|Percentage of Participants With Retention in Care Completed and With Documented Clinical Visit|Percentage of participants with retention in care completed and with documented clinical visit (within 90 days of discontinuation) were reported.|Up to Week 48|The modified ITT analysis set included all participants who were randomized and received at least one dose of study treatment and are HIV-1 positive after enrollment. Here, ‘N’ (number of participants analyzed) signifies participants who were evaluable for this OM. Here, n (number analyzed) signifies participants analyzed at specified categories.|||Percentage of participants|||Number
2534911|NCT03227861|Secondary|Percentage of Participants Lost-to-Follow-up Throughout the 48 Weeks of Treatment|Percentage of participants lost-to-follow-up throughout the 48 Weeks of treatment were reported.|Up to Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.|||Percentage of participants|||Number
2534912|NCT03227861|Secondary|Percentage of Participants Developing Resistance-associated Mutation (RAMs) and Loss of Phenotypic Susceptibility, Upon Meeting Protocol-defined Virologic Failure (PDVF)|Percentage of participants developing RAMs and loss of phenotypic susceptibility, upon meeting PDVF were reported. Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA greater than or equal to (>=) 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA <50 copies/mL, a rebound in HIV 1 RNA to >= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a >1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.|Up to Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.|||Percentage of participants|||Number
2534913|NCT03227861|Secondary|Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 24 and 48|Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA <1 log10 reduction from baseline, and HIV-1 RNA >= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA <50 copies/mL, a rebound in HIV 1 RNA to >= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a >1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.|Week 24 and 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.|||Percentage of participants|||Number
2534914|NCT03227861|Secondary|Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs)|Percentage of Participants with resistance-associated mutations present at baseline were reported and included mutations in the domain of PR, RT (including nucleoside reverse transcriptase inhibitor [NRTIs] and non-nucleoside/nucleotide reverse transcriptase inhibitor [NNRTIs]), INI, RAMs as determined by the GenoSure Prime assay. Genotypes were not available for 7 participants due to failed amplification of viral deoxyribo nucleic acid (DNA) (that is, low viral load (VL) [<500 copies/mL], reduced viral fitness, compromised sample collection/handling, primer incompatibility).|Baseline (Day 1)|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, N (number of participants analyzed) signifies participants evaluated for this endpoint.|||Percentage of Participants|||Number
2534915|NCT03227861|Secondary|Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Treatment Due to Baseline Resistance Findings|Percentage of participants meeting resistance stopping rules, requiring discontinuation of study treatment due to baseline resistance findings were reported. Investigator reviewed antiretroviral screening/baseline resistance data at Week 4, depending on availability of screening/baseline HIV genotypic drug resistance testing results from central laboratory. Participants who do not show full sensitivity to all drugs in the fixed-dose combination (FDC) study regimen according to the susceptibility assessment in the Genosure Prime report will be contacted to return to study site for early study treatment discontinuation (ESTD). Participants with identified resistance to lamivudine/Emtricitabine, attributed to the presence of the M184I/V mutation alone will be permitted to remain in the study.|Up to Day 35|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.|||Percentage of participants|||Number
2534916|NCT03227861|Secondary|Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities|Percentage of participants experiencing grade 3 and 4 laboratory abnormalities was assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.|Up to Week 48|The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
2534917|NCT03227861|Secondary|Percentage of Participants Experiencing Grade 3 and 4 Adverse Events|AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.|Up to Week 48|The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
2534918|NCT03227861|Secondary|Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs)|Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Up to Week 48|The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
2544739|NCT02954952|Other Pre-specified|Total Anesthesia Drug Used, PSI 1.X vs. PSI 2.X|Compare the total amount of anesthesia drug used between the PSI 1.X group and the PSI 2.X group.|Through study completion|||||||
2534919|NCT03227861|Secondary|Number of Participants That Required Discontinuation After Enrollment Based on Safety Stopping Rules|Number of participants that required discontinuation after enrollment based on safety stopping rules were reported. Stopping rules include the following reasons: a). Estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) formula < 50 milliliter per minute (mL/min) b). Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to (>=) 2.5*upper limit of normal (ULN); c). Serum lipase >=1.5*ULN; d). Positive serum human chorionic gonadotropin pregnancy test (beta-hCG) for women of childbearing potential; e). Laboratory results that the investigator believes should result in discontinuation of study medication; f). Participants identified with active hepatitis C virus (HCV) infection that in the opinion of the investigator requires HCV treatment immediately or expected to be needed during the course of the study with agents not compatible with D/C/F/TAF FDC.|Up to Week 48|The safety analysis was performed on the ITT analysis set which included all enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2534920|NCT03227861|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48|The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Weeks 12, 24 and 48 were assessed.|Baseline, Weeks 12, 24 and 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here, n (number analyzed) signifies participants analyzed for this OM at specified timepoints.|||Cells per millimeter cube (cells/mm^3)||Standard Error|Mean
2534921|NCT03227861|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24|Percentage of participants with HIV-1 RNA < 50 copies/mL were reported.|Week 24|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.|||Percentage of Participants||95% Confidence Interval|Number
2534922|NCT03227861|Secondary|Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48|Change from baseline in log10 HIV-1 RNA viral load (<50/200 copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 were reported.|Baseline, Weeks 2, 4, 8, 12, 24, 36, and 48|The ITT analysis set included all participants who were randomized and received at least one dose of study treatment in study. Here, n (number analyzed) signifies participants analyzed for this outcome measure (OM) at specified timepoints.|||log10 HIV-1 RNA copies per mL||Standard Error|Mean
2534923|NCT03227861|Primary|Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies/mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach|Percentage of participants with a HIV-1 RNA < 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within a window of time, along with study drug discontinuation status. If HIV RNA level is < 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach.|Week 48|The intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.|||Percentage of participants||95% Confidence Interval|Number
2534924|NCT03227692|Secondary|EQ-5D-3L at 6 Month Postoperatively|"EQ-5D is patient reported outcome measure to score patient's health related quality of life with minimum score of -0.111 and maximum score of 1.000.~Higher score means better outcomes."|6 month postoperative||||score on a scale||Standard Deviation|Mean
2534925|NCT03227692|Secondary|Oxford Knee Score at 6 Month Postoperatively|Patient Reported Outcome specific for knee disease. Score range from 0 to 48. Higher score means better outcome.|6 month postoperative||||score on a scale||Standard Deviation|Mean
2534926|NCT03227692|Secondary|KSS-Patient Expectations at 6 Month Postoperatively|"KSS-Patient Expectations is patient-derived score and is a three-question fifteen-point scale that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that operation will improve knee pain, and ability to perform activities of daily living and recreational activities. The post-operative questions reflect the extent to which postoperative outcome has met the patient's pre-operative expectations with respect to pain and function.~The score ranges from 3 to 15. Higher score means better outcomes."|6 month postoperative||||score on a scale||Standard Deviation|Mean
2534927|NCT03227692|Secondary|KSS-function Score at 6 Month Postoperatively|"KSS-function score is patient-derived score and composed of four subgroups and has a maximum score of 100.~Walking and Standing has a maximum value of 30 points, Standard Activities has a maximum of 30 points, Advanced Activities has a maximum of 25 points and Discretionary Activities has a maximum of 15 points.~Lowest possible score is 0. Higher score means better outcomes."|6 month postoperative||||score on a scale||Standard Deviation|Mean
2534928|NCT03227692|Secondary|KSS-Patient Satisfaction at 6 Month Postoperatively|KSS-Patient Satisfaction is patient-derived score and is a five-question 40-point scale that is collected preoperatively and at each follow-up visit. Lowest possible score is 0.|6 month postoperative||||score on a scale||Standard Deviation|Mean
2534929|NCT03227692|Secondary|KSS - Objective Score at 6 Month Postoperatively|"KSS-Objective score is physician-derived component and allows for more than 100 points in patients with greater than 125° of flexion and a stable painless knee as outlined below. Lowest possible score is 0.~Higher score means better outcomes."|6 month postoperative||||score on a scale||Standard Deviation|Mean
2534930|NCT03227692|Secondary|Number of Instrument Trays Used|Number of instrument trays used instraoperatively. This number includes number of Total Knee Arthroplasty specific instrument tray, does not include other general surgical instruments/kits.|Intraoperative||||trays||Standard Deviation|Mean
2534931|NCT03227692|Secondary|Surgery Time|Surgery time from skin incision to closure|Intraoperative||||minutes||Standard Deviation|Mean
2534932|NCT03227692|Primary|Alignment Accuracy of the Knee Tibial Components in Sagittal Plain|Ratio of subject, whose knee implant is positioned within 3 degrees from preoperatively determined target angle, is compared between groups by CT data taken at 6 month after surgery.|Postoperative 6 months|Patients who have CT data at 6 month after surgery were included in the analysis.|||Participants|||Count of Participants
2535172|NCT03217968|Primary|Most Bothersome Migraine-associated Symptom (MBS) Freedom at 2 Hours|The percentage of patients with absence, at 2 hours after the beginning of the e-TNS session, of the most bothersome migraine-associated symptom identified at baseline.|2 hours||||Participants|||Count of Participants
2534934|NCT03227692|Primary|Alignment Accuracy of the Knee Femoral Components in Sagittal Plain|Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.|Postoperative 6 months|Patients who have CT data at 6 month after surgery were included in the analysis.|||Participants|||Count of Participants
2534935|NCT03227692|Primary|Alignment Accuracy of the Knee Femoral Components in Coronal Plain|Ratio of subject, whose knee implant is positioned within 3 degrees from perpendicular to mechanical axis of lower extremity, is compared between groups by CT data taken at 6 month after surgery.|Postoperative 6 months|Patients who have CT data at 6 month after surgery were included in the analysis.|||Participants|||Count of Participants
2534936|NCT03227445|Primary|Percentage of Participants With Zero Errors After 28 Days of Inhaler Use in Each Treatment Phase(Supplementary Estimand: Composite)|Supplementary estimand estimated the composite effect of initial randomized treatment. The analysis was performed using stratified exact logistic model. Participants were included in the model as fixed strata, treatment option was included in the exact statement and period included as fixed effects. Participants who withdrew during period 2 were included in the analysis using early withdrawal data where available or imputation otherwise. Participants who experienced an intercurrent event in Period 1 were excluded from the analysis.|Up to Day 56|ITT Population. Only those participants with data available at specified time point were analyzed.|||Percentage of participants|||Number
2534937|NCT03227445|Secondary|Number of Participants With Atleast One Critical Error After 28 Days of Each Treatment Group Use (Supplementary Estimand: Composite)|Supplementary estimand estimated the composite effect of initial randomized treatment. A sensitivity analysis using the Cochran-Mantel-Haenszel test was performed on participants with discordant results. Participants who withdrew during period 2 were included in the analysis using early withdrawal data where available or imputation otherwise. Participants who experienced an intercurrent event in Period 1 were excluded from the analysis.|Up to Day 56|ITT Population. Only those participants with data available at specified time point were analyzed.|||Participants|||Count of Participants
2534938|NCT03227445|Secondary|Number of Participants With Atleast One Critical Error After 28 Days of Each Treatment Group Use (Primary Estimand: Hypothetical)|A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. Primary estimand is the treatment effect estimated in participants who stayed on their randomised study device sequence and did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. For primary estimand, a sensitivity analysis using Cochran-Mantel-Haenszel test was performed on participants with discordant results. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included.|Up to Day 56|ITT Population. Only those participants with data available at specified time point were analyzed.|||Participants|||Number
2534939|NCT03227445|Primary|Percentage of Participants With Atleast One Error After 28 Days of Inhaler Use in Each Treatment Phase (Supplementary Estimand: Composite)|Supplementary estimand estimated the composite effect of initial randomized treatment. A sensitivity analysis using the Cochran-Mantel-Haenszel test was performed on participants with discordant results. Participants who withdrew during period 2 were included in the analysis using early withdrawal data where available or imputation otherwise. Participants who experienced an intercurrent event in Period 1 were excluded from the analysis.|Up to Day 56||||Percentage of participants|||Number
2534940|NCT03227445|Secondary|Number of Participants With Zero Critical Errors After 28 Days of Each Treatment Group Use (Primary Estimand: Hypothetical)|A checklist for correct use of each inhaler was developed based on the steps identified in the PIL. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. Primary estimand is the treatment effect estimated in participants who stayed on their randomised study device sequence and did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. For primary estimand, a sensitivity analysis using Cochran-Mantel-Haenszel test was performed on participants with discordant results. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included.|Up to Day 56|ITT Population. Only those participants with data available at specified time point were analyzed.|||Participants|||Count of Participants
2534941|NCT03227445|Secondary|Change in Errors for Each Treatment Group in Participants With One or More Errors After 28 Days of Use|Assessment of errors was conducted by health care professionals trained in the correct inhaler use of the three inhalers based on the checklist of errors. The median of overall errors made by each participant was assessed for ELLIPTA and DISKUS + HandiHaler both on Day 1 and Day 28. The difference was calculated by subtracting values of Day 28 from Day1 for each treatment regimen. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included.|Day 1 and Day 28 of each treatment group|ITT Population. Only those participants with data available at specified time point were analyzed.|||Errors per participant||Full Range|Median
2534942|NCT03227445|Secondary|Number of Errors for Each Treatment Group in Participants With One or More Errors After 28 Days of Use (Primary Estimand: Hypothetical)|Participants were provided with the PIL, explaining correct use of the inhaler. Overall error includes both critical and non-critical errors. Assessment of errors was conducted by HCP trained in the correct inhaler use of the three inhalers based on the checklist of errors. Primary estimand is the treatment effect estimated in participants who stayed on their randomised study device sequence and did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. For primary estimand, a sensitivity analysis using Cochran-Mantel-Haenszel test was performed on participants with discordant results. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included.|Up to Day 56|ITT Population. Only those participants with data available at specified time point were analyzed.|||Errors per participant||Full Range|Median
2534943|NCT03227445|Secondary|Change in Errors Per Participant for Each Treatment Group After 28 Days of Use|Assessment of errors was conducted by HCP trained in the correct inhaler use of the three inhalers based on the checklist of errors. The median number of overall errors made by per participant was assessed for ELLIPTA and DISKUS + HandiHaler both on Day 1 and Day 28 for each treatment group. The difference was calculated by subtracting values of Day 28 from Day1 for each treatment regimen. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included.|Day 1 and Day 28 of each treatment group|ITT Population. Only those participants with data available at specified time point were analyzed.|||Errors per participant||Full Range|Median
2534944|NCT03227445|Secondary|Number of Errors Per Participant for Each Treatment Group After 28 Days of Use (Primary Estimand: Hypothetical)|Participants were provided with PIL explaining correct use of inhaler. Overall error includes both critical and non-critical errors. Primary estimand is the treatment effect estimated in participants who stayed on their randomised study device sequence and did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. For primary estimand, a sensitivity analysis using Cochran-Mantel-Haenszel test was performed on participants with discordant results. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included.|Up to Day 56|ITT Population. Only those participants with data available at specified time point were analyzed.|||Errors per participant||Full Range|Median
2534945|NCT03227445|Primary|Percentage of Participants With Atleast One Error After 28 Days of Inhaler Use in Each Treatment Phase (Primary Estimand: Hypothetical)|Primary estimand is the treatment effect estimated in participants who stayed on their randomised study device sequence and did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. For primary estimand, a sensitivity analysis using Cochran-Mantel-Haenszel test was performed on participants with discordant results. Only those participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included|Up to Day 56|ITT Population. Only those participants with data available at specified time point were analyzed.|||Percentage of participants|||Number
2534946|NCT03227445|Secondary|Number of Errors by Type for Each Inhaler After 28 Days of Use in Each Treatment Phase (Primary Estimand: Hypothetical)|The occurrence of each type of error for each inhaler (ELLIPTA, DISKUS or HANDIHALER) were evaluated based on the information collected in Correct Use Checklists. Primary estimand is the treatment effect estimated in participants who stayed on their randomised study device sequence & did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. The participant could attend the visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. For primary estimand, a sensitivity analysis using Cochran-Mantel-Haenszel test was performed on participants with discordant results. Only those participants who completed error assessments for both randomized treatment groups & experienced no intercurrent events were included. The number of error is reported as NA for the type of error which was not applicable to the particular inhaler type|Up to Day 56|ITT Population. Only those participants with data available at specified time point were analyzed.|||Errors|||Number
2534947|NCT03227445|Primary|Percentage of Participants With Zero Errors After 28 Days of Inhaler Use in Each Treatment Phase (Primary Estimand: Hypothetical)|A checklist for correct use of each inhaler was developed in Patient Instruction Leaflets (PIL's). Participants were guided by trained health care provider (HCP) to demonstrate correct use of inhaler. Baseline assessment was conducted when participant initially dispensed the inhaler. Second assessment was conducted after each 28day dosing period. Correct Use Check list was completed by HCP at each visit. Primary hypothetical estimand is the estimate of treatment effect of all participants who stayed on their randomized study device sequence and did not change their standard COPD maintenance medication device to one delivered via ELLIPTA, DISKUS or HANDIHALER, throughout both 28 day treatment periods. Participants could attend visit without the device/s they were randomised to, in which case correct use cannot be assessed as described in the protocol. Participants who completed error assessments for both randomized treatment groups and experienced no intercurrent events were included|Up to Day 56|Intent-to-treat (ITT) Population comprised of all randomized participants, excluding those who were randomized in error, and did not have at least one error assessment at Visit 1. Only those participants with data available at specified time point were analyzed.|||Percentage of participants|||Number
2534948|NCT03226691|Primary|Number of Participants With Sufficient Collection of Hemopoietic Stem Cells (HSCs) Without Serious Adverse Events|Sufficient collection of HSCs (target 2.0x106 CD34+ cells/kg) from the PB after plerixafor mobilization without serious adverse events (SAEs)|1 day|Individuals with SCD age 18 or greater and are willing to donate HSC collection for future gene therapy or gene editing study, if no allogeneic HSC transplantation study was currently available|||Participants|||Count of Participants
2534949|NCT03226392|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ+12) Score|"AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated better quality of life. Overall AQLQ+12 score is the mean of all 32 responses."|Baseline and Week 12|Full Analysis Set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization.|||units on a scale||Standard Error|Least Squares Mean
2534989|NCT03224325|Secondary|AUC0-24: Area Under the Plasma Concentration-time Curve During a Dosing Interval for TAK-831||0.5 hours pre-dose and at multiple timepoint (Up to 24 hours) post-dose on Days 1 and 16|The PK set included all participants from the safety set who had at least 1 measurable post dose TAK-831 plasma concentration with data available for this outcome measure.|||hr*ng/mL||Standard Deviation|Mean
2534950|NCT03226392|Secondary|Change From Baseline in Number of Puffs of SABA Taken Per Day|Daily use of SABA (the number of rescue medication puffs taken in the previous 12 hours) was recorded using a patient electronic diary (referred to as eDiary or eDiary/ePEF). Patients were instructed to routinely complete the patient diary twice daily - at the same time each morning and each evening, approximately 12 hours apart.|Baseline (daily mean for up to three weeks prior to baseline visit) and Week 12 (daily mean post baseline up to Week 12)|Full Analysis Set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization.|||Puffs per day||Standard Error|Least Squares Mean
2534951|NCT03226392|Secondary|Change From Baseline in Daytime Asthma Symptom Score|Daytime asthma symptoms are evaluated through four questions and each of them will be rated on a scale of 0 to 6. Higher scores indicate more severe asthma-related symptoms. A mean score is calculated for the responses to 4 questions.|Baseline and Week 12|Full Analysis Set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization.|||Score||Standard Error|Least Squares Mean
2534952|NCT03226392|Primary|Change From Baseline in Pre-dose FEV1|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.|Baseline and Week 12|Full Analysis Set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization.|||Liters||Standard Error|Least Squares Mean
2534953|NCT03226353|Primary|Overall Lens Fit Acceptance|Graded on a 0-4 point scale (where 0 = should not be worn, 4=perfect), providing a reason if Grade 2 or less|Dispense and 1 Week|71 participants completed all protocol visits, two are completely excluded from all analyses because of protocol deviations and adverse event.Two participants were habitual wearers of omafilcon A lenses and not necessary to dispense new lenses.They are not included in the omafilcon A dispense analysis but included in the omafilcon A 1-week analysis|||units on a scale||Standard Deviation|Mean
2534954|NCT03226353|Primary|Lens Fit - Lens Wettability|Graded on a scale of 0-4 with 0.25 increments, 0=excellent; 4=severely reduced.|Dispense and 1 Week|71 participants completed all protocol visits, two are completely excluded from all analyses because of protocol deviations and adverse event.Two participants were habitual wearers of omafilcon A lenses and not necessary to dispense new lenses.They are not included in the omafilcon A dispense analysis but included in the omafilcon A 1-week analysis|||units on a scale||Standard Deviation|Mean
2534955|NCT03226353|Primary|Lens Fit - Centration|(3 point scale: optimum, decentration acceptable, decentration unacceptable)|Dispense and 1 Week|71 participants completed all protocol visits, two are completely excluded from all analyses because of protocol deviations and adverse event.Two participants were habitual wearers of omafilcon A lenses and not necessary to dispense new lenses.They are not included in the omafilcon A dispense analysis but included in the omafilcon A 1-week analysis|||Participants|||Count of Participants
2534956|NCT03226353|Primary|Lens Fit - Lens Deposition|Graded on a scale of 0-4, with 0.25 increments, 0=no deposits; 4=deposit ≥ 0.5mm or film >75% surface.|Dispense and 1 week|71 participants completed all protocol visits, two are completely excluded from all analyses because of protocol deviations and adverse event.Two participants were habitual wearers of omafilcon A lenses and not necessary to dispense new lenses.They are not included in the omafilcon A dispense analysis but included in the omafilcon A 1-week analysis|||units on a scale||Standard Deviation|Mean
2534957|NCT03226353|Primary|Lens Fit - Lens Tightness|Graded using 0-100 scale (5% steps) where 0 = extremely loose and 100 = extremely tight.|Dispense and 1 week|71 participants completed all protocol visits, two are completely excluded from all analyses because of protocol deviations and adverse event.Two participants were habitual wearers of omafilcon A lenses and not necessary to dispense new lenses.They are not included in the omafilcon A dispense analysis but included in the omafilcon A 1-week analysis|||units on a scale||Standard Deviation|Mean
2534958|NCT03226353|Primary|Lens Fit - Post-blink Lens Movement|Graded on a scale of 0-4, 1 step, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement.|Dispense and 1 Week|71 participants completed all protocol visits, two are completely excluded from all analyses because of protocol deviations and adverse event.Two participants were habitual wearers of omafilcon A lenses and not necessary to dispense new lenses.They are not included in the omafilcon A dispense analysis but included in the omafilcon A 1-week analysis|||units on a scale||Standard Deviation|Mean
2534959|NCT03226353|Primary|Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A?|Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)|1 week|Though 71 participants completed all protocol visits, two are completely excluded from all analyses. One participant was excluded because of three protocol deviations and other Participant was excluded because of an adverse event (non-significant ocular from Omafilcon A).|||Participants|||Count of Participants
2534960|NCT03226353|Primary|Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day?|Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)|1 week|Though 71 participants completed all protocol visits, two are completely excluded from all analyses. One participant was excluded because of three protocol deviations and other Participant was excluded because of an adverse event (non-significant ocular from Omafilcon A).|||Participants|||Count of Participants
2534961|NCT03226353|Primary|Investigator Assessment to Refit- Based on the Investigator Opinion and Lens Fit Outcomes, Would the Investigator Refit the Subject Into Somofilcon A From Omafilcon A?|Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)|1 week|Though 71 participants completed all protocol visits, two are completely excluded from all analyses. One participant was excluded because of three protocol deviations and other Participant was excluded because of an adverse event (non-significant ocular from Omafilcon A).|||Participants|||Count of Participants
2539486|NCT03070730|Secondary|Change in Physical Functioning-FSS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Fatigue Severity Scale.|1 week after second intervention|||||||
2534962|NCT03226353|Primary|Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A?|Investigator level of agreement using a Likert scale on refitting participants from omafilcon A to somofilcon A at Visit 1 (Strongly Agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree)|1 week|Though 71 participants completed all protocol visits, two are completely excluded from all analyses. One participant was excluded because of three protocol deviations and other Participant was excluded because of an adverse event (non-significant ocular from Omafilcon A).|||Participants|||Count of Participants
2534963|NCT03226275|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Death, and AEs Leading to Discontinuation|An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration. TEAEs included both Serious TEAEs and non-serious TEAEs.|Baseline up to Day 29|The Safety Analysis Set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2534964|NCT03226275|Secondary|Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/f) of Bisoprolol and Amlodipine|Vz/f is defined as the distribution of a study drug between plasma and the rest of the body after oral dosing.|Pre-dose (Baseline) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose for each treatment period|"The Pharmacokinetic analysis set. Here, “Number Analyzed signified those participants who were evaluable for the specified category."|||liter||Geometric Coefficient of Variation|Geometric Mean
2534965|NCT03226275|Secondary|Apparent Total Body Clearance From Plasma (CL/f) of Bisoprolol and Amlodipine|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Pre-dose (Baseline) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose for each treatment period|"The Pharmacokinetic analysis set. Here, “Number Analyzed signified those participants who were evaluable for the specified category."|||liter per hour||Geometric Coefficient of Variation|Geometric Mean
2534966|NCT03226275|Secondary|Apparent Terminal Elimination Rate Constant (λz) of Bisoprolol and Amlodipine|λz was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.|Pre-dose (Baseline) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose for each treatment period|"The Pharmacokinetic analysis set. Here, “Number Analyzed signified those participants who were evaluable for the specified category."|||1 per hour||Geometric Coefficient of Variation|Geometric Mean
2534967|NCT03226275|Secondary|Extrapolated Part of Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUCextra%) of Bisoprolol and Amlodipine|AUCextra% was calculated as area under the curve from time tlast extrapolated to infinity given as percentage of AUC 0-infinity. Here, tlast is the last sampling time at which the concentration is at or above the lower limit of quantification.|Pre-dose (Baseline) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose for each treatment period|The Pharmacokinetic analysis set.|||percentage of AUC0-inf||Geometric Coefficient of Variation|Geometric Mean
2534968|NCT03226275|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC 0-inf) of Bisoprolol and Amlodipine||Pre-dose (Baseline) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose for each treatment period|"The Pharmacokinetic analysis set. Here, “Number Analyzed signified those participants who were evaluable for the specified category."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2534969|NCT03226275|Secondary|Apparent Terminal Half-life (t1/2) of Bisoprolol and Amlodipine|Apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination. Terminal half-life was calculated as ln(2)/λz, where λz is a terminal rate constant, which was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.|Pre-dose (Baseline) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose for each treatment period|"The Pharmacokinetic analysis set. Here, “Number Analyzed signified those participants who were evaluable for the specified category."|||hours||Geometric Coefficient of Variation|Geometric Mean
2534970|NCT03226275|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Bisoprolol and Amlodipine||Pre-dose (Baseline) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose for each treatment period|The Pharmacokinetic analysis set.|||hours||Full Range|Median
2534971|NCT03226275|Primary|Maximum Observed Plasma Concentration (Cmax) of Bisoprolol and Amlodipine||Pre-dose (Baseline) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose for each treatment period|The Pharmacokinetic analysis set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2534972|NCT03226275|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Bisoprolol and Amlodipine||Pre-dose (Baseline) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose for each treatment period|The Pharmacokinetic (PK) Analysis Set included all participants who completed the study with adequate study medication compliance, without any relevant protocol violations with respect to factors likely to affect comparability of PK results, and with sufficient evaluable data to determine primary endpoints (AUC0-t and Cmax ) for both treatments.|||nanogram hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2534990|NCT03224325|Secondary|Tmax: Time of First Occurrence of Cmax for TAK-831||0.5 hours pre-dose and at multiple timepoint (Up to 24 hours) post-dose on Days 1 and 16|The PK set included all participants from the safety set who had at least 1 measurable post dose TAK-831 plasma concentration. Number analyzed is the number of participants with data available for analysis for the given timepoint.|||hours (hr)||Full Range|Median
2534973|NCT03225599|Primary|Change in Concussive Symptoms on the Post Concussion Symptom Scale|"The Post Concussion Symptom Scale (PCSS) is a scale used to subjectively measure concussion symptoms. The minimum score is 0 and the maximum score is 132 (a maximum score of 6 for 22 items). The higher the value the worse the symptom. Twenty-two possible symptoms are graded and are the following:Headache, Nausea, Vomiting, Balance Problems, Dizziness, Lightheadedness, Fatigue, Trouble falling asleep, Sleeping more than usual, Sleeping less than usual, Drowsiness, Sensitivity to light, Sensitivity to noise, Irritability, Sadness, Nervous/Anxious, Feeling more emotional, Numbness or tingling, Feeling slowed down, Feeling like in a fog, Difficulty concentrating, Difficulty remembering, and/or Visual problems. Total score can range from 0 to 132. Units of a scale is used."|2 months||||units on a scale||Standard Deviation|Mean
2534974|NCT03225573|Primary|Number of Maxillary Molars With a Second Mesiobuccal Canal|measuring device is CBCT software On Demand 3D® , measuring unit is binary system (yes/no)|1 month||||molar teeth|molar teeth||Count of Units
2534975|NCT03225313|Secondary|Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique.|Measurement of serum noradrenaline levels (ng/ml) using ELISA technique 30 minutes before the start of the surgery.|30 minutes before the start of the surgery.|Measurement of serum noradreline levels (ng/ml) using ELISA technique 30 minutes before the start of the surgery.|||ng/ml||Standard Deviation|Mean
2534976|NCT03225313|Secondary|Measurement of Serum Adrenaline Level (ng/ml) Using ELISA Technique.|Measurement of serum adrenaline level (ng/ml) using ELISA technique 30 minutes before the start of the surgery.|30 minutes before the start of the surgery|Measurement of serum adrenaline level (ng/ml) using ELISA technique 30 minutes before the start of the surgery.|||ng/ml||Standard Deviation|Mean
2534977|NCT03225313|Secondary|Measurement of Serum Cortisol Level (Nmol/ Liter) Using ELISA Technique.|Measurement of serum cortisol level (nmol/ liter) using ELISA technique 30 minutes before the start of the surgery|30 minutes before the start of the surgery|Measurement of serum cortisol level (nmol/ liter) using ELISA technique 30 minutes before the start of the surgery|||nmol/ liter||Standard Deviation|Mean
2534978|NCT03225313|Secondary|Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique.|Measurement of serum noradrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.|1 hour after the start of the surgery|Measurement of serum noradrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.|||ng/ml||Standard Deviation|Mean
2534979|NCT03225313|Secondary|Measurement of Serum Adrenaline Levels (ng/ml) Using ELISA Technique.|Measurement of serum adrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.|1 hour after the start of the surgery using ELISA technique.|Measurement of serum adrenaline levels (ng/ml) 1 hour after the start of the surgery using ELISA technique.|||ng/ml||Standard Deviation|Mean
2534980|NCT03225313|Secondary|Change in the Level of Serum Cortisol.|Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery.|Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery.|Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery.|||nmol/ liter||Standard Deviation|Mean
2534981|NCT03225313|Primary|Postoperative Pain at 6 Hours After Procedure.|"Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale.~0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved."|Evaluation of postoperative pain in patients at 6 hours after procedure.|"Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale.~0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved."|||score on a scale||Standard Deviation|Mean
2534982|NCT03225313|Primary|Postoperative Pain at 2 Hours After Procedure.|"Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale.~0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved."|evaluation of postoperative pain in patients at 2 hours after procedure.|"Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale.~0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved."|||score on a scale||Standard Deviation|Mean
2534983|NCT03225313|Primary|Immediate Postoperative Pain|"Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale.~0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved."|evaluation of postoperative pain in patients immediately after the procedure.|"Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale.~0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved."|||score on a scale||Standard Deviation|Mean
2534984|NCT03225001|Secondary|Number of Participants With Mortality From Any Cause|Cardiovascular cause is also included|30 Days||||Participants|||Count of Participants
2534985|NCT03225001|Primary|Number of Participants With All-Cause Mortality, All Stroke, Moderate or Severe Obstruction, or Moderate or Severe Paravalvular Leak (Composite)|The primary endpoint of all-cause mortality, all stroke, moderate or severe obstruction, or moderate or severe paravalvular leak|30-day|Twenty-nine patients had missing echocardiography data.|||Participants|||Count of Participants
2534986|NCT03224598|Primary|Physician's DPN Lesions Assessment|"Efficacy endpoints will include summary statistics (frequency distributions, proportions, means, medians and standard deviations, as appropriate) by visit for the following parameters: Physician's DPN Lesion Assessment scale results per treated lesion, subject responders defined by Physician's DPN Lesion Assessment scale outcome, and changes from baseline treated lesion diameter~Physician's DPN Lesion Assessment Grade Descriptor 0 Clear: no visible DPN lesion;~Near Clear: a slightly visible DPN lesion; lesion may be macular~Small: a visible DPN lesion with a diameter of less than 3 mm~Large : a visible DPN lesion that is elevated with a diameter of ≥3 mm"|Day 106|per-protocol|||score on a scale (PLA)||Standard Deviation|Mean
2534987|NCT03224390|Secondary|Uptake of Long-acting Contraception|Woman reports starting any long-acting method of contraception since the start of the study|1-month post-encouragement|data were not collected||||||
2534991|NCT03224325|Secondary|Cmax ss: Maximum Observed Steady-state Plasma Concentration During a Dosing Interval for TAK-831||0.5 hours pre-dose and at multiple timepoint (Up to 24 hours) post-dose on Day 16|The PK set included all participants from the safety set who had at least 1 measurable post dose TAK-831 plasma concentration with data available for this outcome measure.|||ng/mL||Standard Deviation|Mean
2534992|NCT03224325|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-831||0.5 hours pre-dose and at multiple timepoint (Up to 24 hours) post-dose on Day 1|The PK set included all participants from the safety set who had at least 1 measurable post dose TAK-831 plasma concentration.|||ng/mL||Standard Deviation|Mean
2534993|NCT03224325|Primary|Percentage of Participants Who Met the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Postdose|A 12-lead ECG was performed. Markedly abnormal values during treatment period were categorized as: ECG Mean Heart Rate (beats/min) <50->120, PR Interval, Aggregate (msec) <=80->=200, QRS Duration, Aggregate (msec) <=80->=180, QT Interval, Aggregate (msec) <=300->=460, QTcF Interval, Aggregate (msec) <=300->=500 OR >=30 change from baseline and >=450 milliseconds.|Baseline up to 30 days after the last dose (Up to 48 days)|Safety set included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2534994|NCT03224325|Primary|Percentage of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Postdose|Vital signs included temperature, pulse rate and blood pressure. Markedly abnormal values during treatment period were categorized as: Pulse Rate (beats/min) <50->120, Systolic Blood Pressure (SBP) (mmHg) <85->180, Diastolic Blood Pressure (DBP) (mmHg) <50->110 and Temperature (degree centigrades) <35.6- >37.7.|Baseline up to 30 days after the last dose (Up to 48 days)|Safety set included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2534995|NCT03224325|Primary|Percentage of Participants Who Met the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Postdose|Clinical Laboratory parameters included tests for chemistry, hematology and urinalysis. Markedly abnormal values during treatment period were categorized as: alanine aminotransferase (ALT)>3.0 U/L*upper limit of normal(ULN), albumin<25 g/L, alkaline phosphatase >3.0 U/L*ULN, aspartate aminotransferase >3.0 U/L*ULN, bilirubin >3.42 umol/L creatinine >177umol/L, gamma glutamyl transferase (GGT) >3 U/L*ULN, glucose <2.8 mmol/L, >19.4 mmol/L, potassium<3 mmol/L, >6 mmol/L, sodium <130 mmol/L, >150 mmol/L, protein <0.8 g/L,* lower limit of normal (LLN), >1.2 g/L*ULN, erythrocytes <0.8 (10^12/L)*LLN, >1.2 (10^12/L)*ULN, hematocrit (%) <0.8*LLN, >1.2*ULN, hemoglobin <0.8 g/L*LLN, >1.2 g/L*ULN, leukocytes <0.5 (10^9/L)*LLN, >1.5 (10^9/L)*ULN, platelets <75(10^9/L), >600(10^9/L). Only categories with values have been reported.|Baseline up to 30 days after the last dose (Up to 48 days)|Safety set included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2534996|NCT03224325|Primary|Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.|Baseline up to 30 days after the last dose (Up to 48 days)|Safety set included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2534997|NCT03224130|Secondary|Number of Participants With Occurrence(s) of 14-day Unplanned Healthcare Utilization|Occurrence(s) of 14-day unplanned healthcare utilization defined by unplanned re-hospitalization and/or any emergency/urgent care visit within 14 days or parent report of an unplanned visit to one of these places. Parent report is collected at the 14 day follow-up phone call.|14 days post-discharge|The analysis population includes the total 966 (483 intervention, 483 control) randomized excluding the one subject withdrawn in the control group after randomization due to invalid consent at 14-day follow-up.|||Participants|||Count of Participants
2534998|NCT03224130|Secondary|Number of Participants With Occurrence(s) of an Emergency Department Visit Within 30 Days Post-discharge|Occurence(s) of an ED visit within 30 days post-discharge|30 days|The analysis population includes the total 966 (483 intervention, 483 control) randomized excluding the one subject withdrawn in the control group after randomization due to invalid consent at 14-day follow-up.|||Participants|||Count of Participants
2534999|NCT03224130|Secondary|Number of Participants With Occurrence(s) of an Unplanned Readmission Within 30 Days Post-discharge|Occurrence(s) of an unplanned readmission within 30 days post-discharge.|30 days|The analysis population includes the total 966 (483 intervention, 483 control) randomized excluding the one subject withdrawn in the control group after randomization due to invalid consent at 14-day follow-up.|||Participants|||Count of Participants
2535000|NCT03224130|Secondary|Red Flags Remembered|"This was measured at the 14 day post-discharge phone call survey. Parents were asked to recall any red flags or warning signs to indicate the child's condition was getting worse. The number of red flags recalled could range from 0-10 depending on the template used. The template was a home visit guideline for nurses to use that was specific to the child's illness. For example, if the child had bronchiolitis the nurse would use the template bronchiolitis/croup/pneumonia to guide them through the visit. Higher values (i.e., the greater number of red flags remembered) represent a better outcome."|14 days post-discharge|The analysis population includes the total subjects completing the 14-day phone call survey for this outcome. Of the total randomized (966: 483 intervention, 483 control), 25 were excluded from the intervention group and 23 from the control group.|||units on a scale||95% Confidence Interval|Least Squares Mean
2535001|NCT03224130|Secondary|Number of Days Until Normalcy|"Number of days until normalcy: measured at post discharge phone call. Parents asked to recall the number of days it took to return to a 'normal' routine including the return to work and school (with option of not yet be back to normal)."|14 days post-discharge|The analysis population includes the total subjects completing the 14-day phone call survey for this outcome. Of the total randomized (966: 483 intervention, 483 control), 26 were excluded from the intervention group and 23 from the control group.|||days||95% Confidence Interval|Least Squares Mean
2535069|NCT03222141|Primary|The Composite Rate of All-cause Mortality, All Stroke, and AI ≥ Moderate|The composite rate of all-cause mortality, all stroke, and AI ≥ moderate for patients deemed as 'high risk' using the Edwards SAPIEN 3 transcatheter heart valve (THV).|30 Days||||percentage of patients||90% Confidence Interval|Number
2535002|NCT03224130|Secondary|Post-Discharge Coping Scale|Post-Discharge Difficulty Coping Scale (Weiss, et. al): measured at 14 day post-discharge phone call. Post-Discharge Coping Difficulty Scale uses an 11 point scaling format (0-10) with total scores ranging from 0 to 100. Higher scores represent greater coping difficulty. Differences between intervention and control groups on this outcome at 14-day post-discharge are evaluated using a linear regression model with the stratification variables (census tract poverty and state of residence).|14 days post-discharge|The analysis population includes the total subjects completing the 14-day phone call survey for this outcome. Of the total randomized (966: 483 intervention, 483 control), 26 were excluded from the intervention group and 23 from the control group.|||units on a scale||95% Confidence Interval|Least Squares Mean
2535003|NCT03224130|Primary|Number of Participants With Any Occurrence of Unplanned Re-hospitalization and/or Any Emergency/Urgent Care Visits Within 30 Days of Hospital Discharge|The dependent variable will be a dichotomized indicator of any occurrence of unplanned rehospitalization, ED or urgent care visit within 30-days post-discharge (i.e. unplanned reutilization). Differences in this outcome between intervention and control groups will be evaluated using logistic regression with the stratification variables (neighborhood poverty and state)|30 days post-discharge|The analysis population includes the total 966 (483 intervention, 483 control) randomized excluding the one subject withdrawn in the control group after randomization due to invalid consent at 14-day follow-up.|||Participants|||Count of Participants
2535004|NCT03223909|Secondary|Corneal Epithelization Defects With Fluorescein|Percentage of the damaged epithelium of the ocular surface, reduction of staining according to the oxford scale.|Final Visit (day 90)|the statistical analysis was carried out by intention to treat|||percentage of defects|||Number
2535005|NCT03223909|Secondary|Goblet Cells Population|Increase of 20% from baseline|Change from Baseline Goblet cells population at 90 days|the statistical analysis was carried out by intention to treat|||cells/mm^2||Standard Deviation|Mean
2535006|NCT03223909|Secondary|Ocular Surface Disease Index (OSDI)|"The OSDI, which was created to order to quickly assess the symptoms of ocular irritation in dry eye disease and how they affect functioning related to vision. This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to none of the time and 4 corresponding to all of the time. A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease."|Change from Baseline OSDI at 90 days|The statistical analysis was carried out by intention to treat|||score on a scale||Standard Deviation|Mean
2535007|NCT03223909|Secondary|Adverse Events|Presence of adverse events modifying some of the abovementioned criteria or others, evaluated as serious.|90 days|Statistical analysis was performed by protocol (PP)|||percentage of adverse events|||Number
2535008|NCT03223909|Secondary|Schirmer Test|Schirmer's test determines whether the eye produces enough tears to keep it moist. This test is used when a person experiences very dry eyes or excessive watering of the eyes. It poses no risk to the subject. A negative (more than 10 mm of moisture on the filter paper in 5 minutes) test result is normal. Both eyes normally secrete the same amount of tears.|Base line and Final Visit (day 90)||||mm||Standard Deviation|Mean
2535009|NCT03223909|Secondary|Tear Film Break-up Time (TBUT)|Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film, as seen in this progression of these slit lamps photos over time. A TBUT under 10 seconds is considered abnormal|Base line and Final Visit (day 90)||||seconds||Standard Deviation|Mean
2535010|NCT03223909|Secondary|Corneal Epithelization Defects With Rose of Bengal|Percentage of the damaged epithelium of the ocular surface, reduction of staining according to the oxford scale.|Final Visit (day 90)|the statistical analysis was carried out by intention to treat|||percentage of defects|||Number
2535011|NCT03223909|Primary|Visual Acuity|Best-corrected visual acuity|Change from Baseline visual acuity at 90 days|the statistical analysis was carried out by intention to treat (ITT)|||LogMAR||Standard Deviation|Mean
2535012|NCT03223662|Secondary|Overall Survival (OS) in Esophageal Adenocarcinoma (EAC) and Esophageal Squamous Cell Carcinoma (ESCC) Patients Undergoing Neoadjuvant Chemoradiotherapy (nCRT) and Esophagectomy|Overall survival is defined as the time from treatment start date until date of death or date last known alive.|From treatment start date until date of death or date last known alive.|This outcome measure was not done because one patient was deemed to be unsafe/unfit for surgery by the doctor. And the second patient was taken off-study prior to surgery because the principal investigator left the National Institutes of Health and closed the trial.||||||
2535013|NCT03223662|Secondary|Disease-free Survival in Esophageal Adenocarcinoma (EAC) and Esophageal Squamous Cell Carcinoma (ESCC) Patients Undergoing Neoadjuvant Chemoradiotherapy (nCRT) and Esophagectomy|Disease-free survival is defined as the appearance of any new lesion that is likely metastatic or locally-recurrent esophageal cancer and will be assessed from the time of esophagectomy until development of metastatic disease or death, whichever comes first|From the time of esophagectomy until development of metastatic disease or death, whichever comes first|This outcome measure was not done because one patient was deemed to be unsafe/unfit for surgery by the doctor. And the second patient was taken off-study prior to surgery because the principal investigator left the National Institutes of Health and closed the trial.||||||
2535014|NCT03223662|Secondary|Tumor Protein 53 (p53) Mutational Status and the Metabolomic Profiles|One tumor sample and one normal esophagus sample will be obtained. p53 mutational analysis will be performed to determine mutational status and the metabolomic profiles .|Pre-neoadjuvant therapy within 4 weeks, and after neoadjuvant therapy >4 weeks but prior to surgery|This outcome measure was not done. Neither patient enrolled in the trial underwent resection based on post neoadjuvant therapy assessment of resectability. These patients were initially deemed potentially resectable prior to neoadjuvant therapy, but their course deviated from the initial plans.||||||
2535070|NCT03222128|Secondary|Composite of All-cause Death, All Stroke, Life Threatening (Disabling)/ Major Bleeding and Major Vascular Complication at 30 Days||30 Days||||Participants|||Count of Participants
2535015|NCT03223662|Secondary|Metabolomic Signatures or BH3 Profiling in Tumor, Blood, or Urine of Esophageal Adenocarcinoma (EAC) and Esophageal Squamous Cell Carcinoma (ESCC) With Major Responses (Mandard Score of 1 and 2) Versus Minimal Response (Mandard Score 3-5)|Specimens of tumor, blood, or urine will be obtained to determine metabolomic signatures or BH3 profiling in tumor, blood, or urine of EAC and ESCC with major responses (Mandard score of 1 and 2) versus minimal response (Mandard score 3-5). Grade 1-2 is better survival than Grade 3-5.|Pre-neoadjuvant therapy within 4 weeks, and after neoadjuvant therapy >4 weeks but prior to surgery|This outcome measure was not done. Neither patient enrolled in the trial underwent resection based on post neoadjuvant therapy assessment of resectability. These patients were initially deemed potentially resectable prior to neoadjuvant therapy, but their course deviated from the initial plans.||||||
2535016|NCT03223662|Secondary|Metabolomic Profiles and B-cell Lymphoma (Bcl-2) Homology Domain-3 (BH-3) Profiling in Resectable Esophageal Adenocarcinomas (EAC) and Esophageal Squamous Cell Carcinoma (ESCC) Treated With Neoadjuvant Chemoradiotherapy (nCRT)|Evaluation of metabolomic profiles and Bcl-2 homology domain-3 (BH-3) profiling in resectable esophageal adenocarcinomas (EAC) and esophageal squamous cell carcinoma (ESCC) treated with neoadjuvant chemoradiotherapy (nCRT)|Pre-neoadjuvant therapy within 4 weeks, and after neoadjuvant therapy >4 weeks but prior to surgery|This outcome measure was not done. Neither patient enrolled in the trial underwent resection based on post neoadjuvant therapy assessment of resectability. These patients were initially deemed potentially resectable prior to neoadjuvant therapy, but their course deviated from the initial plans.||||||
2535017|NCT03223662|Primary|BH3 Profiling of Pre-neoadjuvant Tumor Biopsy and Outcome of Pathological Complete Response After Neoadjuvant Chemoradiotherapy in Patients With Esophageal Adenocarcinoma or Squamous Cell Carcinoma|Two tumor samples and two normal esophagus samples will be obtained for BH3 profiling of pre-neoadjuvant tumor biopsy and outcome of pathological complete response after neoadjuvant chemoradiotherapy in patients with esophageal adenocarcinoma or squamous cell carcinoma. Response will be defined by the Mandard Score. Major response with no viable tumor (Grade 1) and <10% viable tumor (Grade 2) versus non major response of >10% viable tumor (Grade 3-5) as assessed by final pathology. Grade 1-2 is better survival than Grade 3-5.|Pre-neoadjuvant therapy within 4 weeks, and after neoadjuvant therapy >4 weeks but prior to surgery|Neither patient enrolled in the trial underwent resection based on post neoadjuvant therapy assessment of resectability. These patients were initially deemed potentially resectable prior to neoadjuvant therapy, but their course deviated from the initial plans. Therefore, the primary endpoint cannot be assessed.||||||
2535018|NCT03223662|Primary|Metabolomic Signature in Tumor, Blood, or Urine and Outcome of Pathological Complete Response After Neoadjuvant Chemoradiotherapy in Patients With Esophageal Adenocarcinoma or Squamous Cell Carcinoma|Specimens of normal esophagus, esophageal tumors, blood, or urine will be analyzed to determine specific signatures and outcome of pathological complete response after neoadjuvant chemoradiotherapy in patients with esophageal adenocarcinoma or squamous cell carcinoma. Response will be defined by the Mandard Score. Major response with no viable tumor (Grade 1) and <10% viable tumor (Grade 2) versus non major response of >10% viable tumor (Grade 3-5) as assessed by final pathology. Grade 1-2 is better survival than Grade 3-5.|After neoadjuvant therapy >4 weeks but prior to surgery|Neither patient enrolled in the trial underwent resection based on post neoadjuvant therapy assessment of resectability. These patients were initially deemed potentially resectable prior to neoadjuvant therapy, but their course deviated from the initial plans. Therefore, the primary endpoint cannot be assessed.||||||
2535019|NCT03223337|Secondary|Part 2: Number of Participants With Abnormal Urinalysis Findings|Urine samples were collected at indicated time points for the analysis of urine parameters including specific gravity and Potential of hydrogen (pH) of urine, presence of glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, and leukocyte esterase in urine.|Up to Day 16|Safety Population|||Participants|||Count of Participants
2535020|NCT03223337|Secondary|Part 1: Number of Participants With Abnormal Urinalysis Findings|Urine samples were collected at indicated time points for the analysis of urine parameters including specific gravity and Potential of hydrogen (pH) of urine, presence of glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, and leukocyte esterase in urine.|Up to Day 16|Safety Population|||Participants|||Count of Participants
2535021|NCT03223337|Secondary|Part 2: Number of Participants With Worst Case Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline|Blood samples were collected for analysis of following parameters. PCI ranges were <30g/L (albumin), <2 or >2.75 mmol/L (calcium), <3 or >9mmol/L (glucose), >=2 times ULN U/L (ALT), >=2 times ULN U/L (alkaline phosphatase), >=2 times ULN U/L (AST), >=1.5 times ULN µmol/L (bilirubin), <3 or >5.5 mmol/L (potassium), and <130 or >150 mmol/L (sodium). Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in To within Range or No Change category. Participants were counted twice if the participant has values that changed To Low and To High, so the percentages may not add to 100%. Baseline is defined as latest non-missing scheduled pre-dose assessment.|Baseline (Screening) and up to Day 16|Safety Population|||Participants|||Count of Participants
2535022|NCT03223337|Secondary|Part 1: Number of Participants With Worst Case Chemistry Results Relative to PCI Criteria Post-Baseline Relative to Baseline|Blood samples were collected for analysis of following parameters. PCI ranges were <30g/L (albumin), <2 or >2.75 millimoles/L(mmol/L) (calcium), <3 or >9mmol/L(glucose), >=2 times Upper limit of Normal(ULN) units/L(U/L) (alanine aminotransferase [ALT]), >=2 times ULN U/L (alkaline phosphatase), >=2 times ULN U/L(aspartate aminotransferase [AST]), >=1.5 times ULN micromoles/L (µmol/L)(bilirubin), <3 or >5.5mmol/L(potassium), and <130 or >150mmol/L(sodium). Participants were counted in worst case category that their value changes to (low,within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in To within Range or No Change category. Participants were counted twice if participant has values that changed To Low and To High, so the percentages may not add to 100%. Baseline is defined as latest non-missing scheduled pre-dose assessment.|Baseline (Screening) and up to Day 16|Safety Population|||Participants|||Count of Participants
2535071|NCT03222128|Primary|Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ Moderate||1 year|AI as a factor in this value; only 964/1069 patients had ECHO data.|||Participants|||Count of Participants
2535023|NCT03223337|Secondary|Part 2: Number of Participants With Worst Case Hematology Results Relative to PCI Criteria Post-Baseline Relative to Baseline|"Blood samples were collected for analysis of hematocrit, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. PCI ranges were <0.075 or >0.54 proportion of red blood cells in blood for hematocrit, <25 or >180 g/L for hemoglobin, <3 or >20 x10^9 cells/L for leukocytes, <0.8 x10^9 cells/L for lymphocytes, <1.5 x10^9 cells/L for neutrophils, and <100 or >550 x10^9 cells/L for platelet. Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in To within Range or No Change category. Participants were counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Baseline is defined as latest non-missing scheduled pre-dose assessment."|Baseline (Screening) and up to Day 16|Safety Population|||Participants|||Count of Participants
2535024|NCT03223337|Secondary|Part 1: Number of Participants With Worst Case Hematology Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline|"Blood samples were collected for analysis of hematocrit, hemoglobin, leukocytes, lymphocytes, neutrophils and platelets. PCI ranges were <0.075 or >0.54 proportion of red blood cells in blood for hematocrit, <25 or >180 grams per liter (g/L) for hemoglobin, <3 or >20 x10^9 cells per liter (cells/L) for leukocytes, <0.8 x10^9 cells/L for lymphocytes, <1.5 x10^9 cells/L for neutrophils, and <100 or >550 x10^9 cells/L for platelet. Participants were counted in worst case category that their value changes to (low, within range or no change or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (example given [e.g.], High to High), or whose value became within range, were recorded in To within Range or No Change category. Participants were counted twice if the participant has values that changed 'To Low' and 'To High', so the percentages may not add to 100%. Baseline is defined as latest non-missing scheduled pre-dose assessment."|Baseline (Screening) and up to Day 16|Safety Population|||Participants|||Count of Participants
2535025|NCT03223337|Secondary|Part 2: Number of Participants With AEs and SAEs|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation as per Medical or scientific judgment.|Up to 16 days|Safety Population|||Participants|||Count of Participants
2535026|NCT03223337|Secondary|Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation as per Medical or scientific judgment. Safety Population comprised of all participants who received at least one dose of study medication.|Up to 16 days|Safety Population|||Participants|||Count of Participants
2535027|NCT03223337|Secondary|Part 2: AUC (0-t, EPO) Following Administration of GSK1278863|Venous blood samples were collected for measurement of plasma EPO at the indicated time points following administration of GSK1278863.|Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, and 48 hours post-dose|Pharmacodynamic Population|||Hours* International units per liter||Standard Deviation|Mean
2535028|NCT03223337|Secondary|Part 1: Erythropoietin Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Last Time of Quantifiable Concentration (AUC [0-t, EPO]) Following Administration of GSK1278863|Venous blood samples were collected for measurement of plasma EPO at the indicated time points following administration of GSK1278863.|Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, and 48 hours post-dose|Pharmacodynamic Population|||Hours* International units per liter||Standard Deviation|Mean
2535029|NCT03223337|Secondary|Part 2: Tmax, EPO Following Administration of GSK1278863|Venous blood samples were collected for measurement of plasma EPO at the indicated time points following administration of GSK1278863.|Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, and 48 hours post-dose|Pharmacodynamic Population|||Hours||Full Range|Median
2535030|NCT03223337|Secondary|Part 1: Time of the Maximum Observed Erythropoietin Concentration (Tmax, EPO) Following Administration of GSK1278863|Venous blood samples were collected for measurement of plasma EPO at the indicated time points following administration of GSK1278863.|Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, and 48 hours post-dose|Pharmacodynamic Population|||Hours||Full Range|Median
2535031|NCT03223337|Secondary|Part 2: Cmax, EPO Following Administration of GSK1278863|Venous blood samples were collected for measurement of plasma EPO at the indicated time points following administration of GSK1278863.|Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, and 48 hours post-dose|Pharmacodynamic Population|||International units per liter||Standard Deviation|Mean
2535032|NCT03223337|Secondary|Part 1: Maximum Observed Erythropoietin Concentration (Cmax, EPO) Following Administration of GSK1278863|Venous blood samples were collected for measurement of plasma EPO at the indicated time points. Pharmacodynamic Population comprised of all participants in the Safety Population who had at least one pharmacodynamic assessment.|Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, and 48 hours post-dose|Pharmacodynamic Population|||International units per liter||Standard Deviation|Mean
2535098|NCT03221192|Primary|Number of Participants Who Reported on the Positive or Negative Impacts of Surgery|During CE interviews, participants were asked about experiences of their surgery in past. The number of participants who reported on the positive or negative impacts of surgery is presented.|Up to 120 minutes|All Enrolled Population|||Participants|||Count of Participants
2545580|NCT02940327|Primary|CD64/163|Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.|24 hours after decannulation||||percentage change||Standard Deviation|Mean
2535033|NCT03223337|Primary|Part 2: Unbound Fraction in Plasma of GSK1278863 and Its Metabolites|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites (GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), GSK2531401 (M13)). Pharmacokinetic parameters were determined using standard non-compartmental methods. Unbound fraction is the percentage of unbound drug in plasma calculated as unbound concentration divided by total concentration.|3 hours, 12 hours and 24 hours post-dose|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percentage of unbound drug in plasma||Standard Deviation|Mean
2535034|NCT03223337|Primary|Part 1: Unbound Fraction in Plasma of GSK1278863 and Its Metabolites|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818, GSK2506102, GSK2531398 (M6), GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods. Unbound fraction is the percentage of unbound drug in plasma calculated as unbound concentration divided by total concentration.|3 hours, 12 hours and 24 hours post-dose|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percentage of unbound drug in plasma||Standard Deviation|Mean
2535035|NCT03223337|Primary|Part 2: Unbound Concentration in Plasma of GSK1278863 and Its Metabolites|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods.|3 hours, 12 hours and 24 hours post-dose|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Nanograms per milliliter||Standard Deviation|Mean
2535036|NCT03223337|Primary|Part 1: Unbound Concentration in Plasma of GSK1278863 and Its Metabolites|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods.|3 hours, 12 hours and 24 hours post-dose|Pharmacokinetic Population|||Nanograms per milliliter||Standard Deviation|Mean
2535037|NCT03223337|Primary|Part 2: Tmax of GSK1278863 and Its Metabolites|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.|||Hours||Full Range|Median
2535038|NCT03223337|Primary|Part 1: Time of Occurrence of Cmax (Tmax) of GSK1278863 and Its Metabolites|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose|Pharmacokinetic Population|||Hours||Full Range|Median
2535039|NCT03223337|Primary|Part 2: T1/2 of GSK1278863 and Its Metabolites|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2535040|NCT03223337|Primary|Part 1: Apparent Terminal Phase Half-life (t1/2) of GSK1278863 and Its Metabolites|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose|Pharmacokinetic Population|||Hours||Geometric Coefficient of Variation|Geometric Mean
2535041|NCT03223337|Primary|Part 2: Cmax of GSK1278863 and Its Metabolites.|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), and GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2535042|NCT03223337|Primary|Part 1: Maximum Observed Concentration (Cmax) of GSK1278863 and Its Metabolites|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose|Pharmacokinetic Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2535043|NCT03223337|Primary|Part 2: AUC (0-t) of GSK1278863 and Its Metabolites|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2535044|NCT03223337|Primary|Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) of GSK1278863 and Its Metabolites|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose|Pharmacokinetic Population|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2535045|NCT03223337|Primary|Part 2: Percentage AUCex of GSK1278863 and Its Metabolites|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.|||Percentage of AUCex||Standard Deviation|Mean
2535046|NCT03223337|Primary|Part 1: Percentage of AUC (0-infinity) Obtained by Extrapolation (Percentage AUCex) of GSK1278863 and Its Metabolites|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), and GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose|Pharmacokinetic Population|||Percentage of AUCex||Standard Deviation|Mean
2535047|NCT03223337|Primary|Part 2: AUC (0-infinity) of GSK1278863 and Its Metabolites|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2) , GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), and GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2535048|NCT03223337|Primary|Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of GSK1278863 and Its Metabolites|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK1278863 and its metabolites; GSK2391220 (M2), GSK2506104 (M3), GSK2487818 (M4), GSK2506102 (M5), GSK2531398 (M6), and GSK2531401 (M13). Pharmacokinetic parameters were determined using standard non-compartmental methods. Pharmacokinetic Population comprised of all participants in the Safety Population for whom a pharmacokinetic sample was obtained and analyzed.|Pre-dose, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours post-dose|Pharmacokinetic Population|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2535049|NCT03222583|Secondary|Percentage of HCV/HIV Co-infected Participants in Arm A Who Achieved SVR12|SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug, Week 20 or 28 depending on the treatment regimen|No HCV-HIV co-infected participants were enrolled in the study||||||
2535050|NCT03222583|Secondary|Percentage of Participants in Arm A With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA greater than or equal to 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < 15 IU/mL at the end of treatment, excluding re-infection.|From the end of treatment (Weeks 8 or 16) through 12 weeks after the last dose of study drug (Weeks 20 or 28 depending on the treatment regimen).|This endpoint was pre-specified to be analyzed in all participants randomized to Arm A who received at least one dose of study drug, with HCV RNA < 15 IU/mL at the end of treatment, at least one post-treatment HCV RNA value, and who completed the assigned treatment.|||percentage of participants||95% Confidence Interval|Number
2535051|NCT03222583|Secondary|Percentage of Participants in Arm A With On-treatment Virologic Failure|"On-treatment virologic failure was defined as meeting one of the following:~confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log₁₀ IU/mL above nadir) at any time point during the treatment period; or~confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA < 15 IU/mL during the treatment period, or~HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment."|8 or 16 weeks depending on the treatment regimen|This endpoint was pre-specified to be analyzed in all participants randomized to Arm A who received at least 1 dose of study drug during the DB Treatment Period.|||percentage of participants||95% Confidence Interval|Number
2535052|NCT03222583|Primary|Percentage of HCV GT2-Infected Participants in Arm A Who Achieved SVR12|SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last actual dose of study drug.|12 weeks after the last dose of study drug, Week 20 or Week 28 depending on the treatment regimen.|This endpoint was pre-specified to be analyzed in genotype 2-infected participants randomized to Arm A who received at least one dose of study drug. Backward imputation, where applicable, was used to impute missing data. Participants with missing data after backward imputation were counted as non-responders.|||percentage of participants|||Number
2535053|NCT03222583|Primary|Percentage of HCV GT1-Infected Participants in Arm A Who Achieved SVR12|SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last dose of study drug.|12 weeks after last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen|This endpoint was pre-specified to be analyzed in GT1-infected participants randomized to Arm A who received at least one dose of study drug. Backward imputation, where applicable, was used to impute missing data. Participants with missing data after backward imputation were counted as non-responders.|||percentage of participants|||Number
2535099|NCT03221192|Primary|Number of Participants With Ease of Decision to Have Surgery|During CE interviews, participants were asked about experiences of their surgery in past. The number of participants with ease of decision to have surgery is presented.|Up to 120 minutes|All Enrolled Population|||Participants|||Count of Participants
2535054|NCT03222583|Primary|Percentage of HCV GT1 - GT6-Infected Participants in Arm A Who Achieved Sustained Virologic Response 12 Weeks Post Treatment (SVR12)|Sustained virologic response 12 weeks post-treatment (SVR12) was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen.|This endpoint was pre-specified to be analyzed in participants randomized to Arm A who received at least 1 dose of study drug during the DB Treatment Period. Backward imputation, where applicable, was used to impute missing data. Participants with missing data after backward imputation were counted as non-responders.|||percentage of participants|||Number
2535055|NCT03222505|Secondary|Change in Percent Excitability of Transcranial Magnetic Stimulation (TMS), Dorsiflexor Tibialis Anterior (TA) Between Device ON and Device OFF|TMS measurements will involve generating motor evoked potentials (MEP) for each muscle from two different coil positions - 2cm on either side of the vertex. Motor evoked potentials (MEPs) at intensities ranging from 70 - 140% active threshold will be generated for each muscle from each coil position. TMS is a safe, non-invasive, painless method of brain stimulation that has been widely used to study the physiology of the representations of muscles in the motor cortex in healthy and neurologically disordered individuals. A positive percent change in excitability indicates higher excitability in the device-on condition. A negative percent change in excitability indicates higher excitability in the device-off condition.|Day 1|Device ON and Device OFF arms were combined as the interest of this metric was the change in excitability between device on and device off conditions within a participant.|||percent change||Standard Deviation|Mean
2535056|NCT03222505|Secondary|Percent Change in Excitability of Transcranial Magnetic Stimulation (TMS) Rectus Femoris (RF) Between Device ON and Device OFF|TMS measurements will involve generating motor evoked potentials (MEP) for each muscle from two different coil positions - 2cm on either side of the vertex. Motor evoked potentials (MEPs) at intensities ranging from 70 - 140% active threshold will be generated for each muscle from each coil position. TMS is a safe, non-invasive, painless method of brain stimulation that has been widely used to study the physiology of the representations of muscles in the motor cortex in healthy and neurologically disordered individuals. A positive percent change in excitability indicates higher excitability in the device-on condition. A negative percent change in excitability indicates higher excitability in the device-off condition.|Day 1|Device ON and Device OFF arms were combined as the interest of this metric was the change in excitability between device on and device off conditions within a participant.|||percent change||Standard Deviation|Mean
2535057|NCT03222505|Primary|Change in Peak Treadmill (TM) Velocity Between Device Turned ON and OFF - Self Selected Walking Speed|Peak treadmill (TM) velocity: subjects walked on motorized treadmill with harness but no Body Weight Support (BWS). Testing started at 0.5 km/h and was increased in 0.5 km/h increments every 3 minutes until peak TM speed was achieved (identified as ability to sustain speed for ≥1min without stopping the treadmill).|Day 1||||meters per second||Standard Deviation|Mean
2535058|NCT03222505|Primary|Change in Six Minute Walk Test Between Device Turned ON and OFF - Distance Traveled|"The 6 Minute Walk Test (6MWT) is a test of endurance, by measuring the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary.The distance is measured with a measuring wheel. The instructions are Walk covering as much ground as you can in 6 min. You can stop to sit or stand if needed."|Day 1||||feet||Standard Deviation|Mean
2535059|NCT03222427|Secondary|Pharmacokinetics: Area Under the Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814|Pharmacokinetics: Area Under the Drug Concentration-Time Curve from Zero to Infinity (AUC[0 ∞]) of LY3314814 and [13C415N3] LY3314814|Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose|All participants who received one dose of study drug and had evaluable PK data.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2535060|NCT03222427|Primary|Absolute Bioavailability of LY3314814|Absolute bioavailability was quantified using a mixed-effects analysis of variance (ANOVA) model applied to the log-transformed dose-normalized AUC(0-∞) of LY3314814 oral dosing and IV administered [13C415N3]-LY3314814.|Day 1: Predose:0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24, 48, 72, 96 and 120 hours post-dose|All participants who received at least one dose of study drug and have evaluable PK data.|||nanogram*hour per milliliter per mg||Geometric Coefficient of Variation|Geometric Mean
2535061|NCT03222414|Secondary|Mean of 2 Diastolic Blood Pressure Non-invasive BP Measurements Taken With Cylindrical and Conical BP Cuffs|Mean of 2 diastolic blood pressure non-invasive BP measurements taken with cylindrical and conical BP cuffs|Single time point measurement (1 day)||||mm Hg||Standard Deviation|Mean
2535062|NCT03222414|Secondary|Mean of 2 MAP Readings Taken With Cylindrical and Conical BP Cuffs|Mean of 2 MAP readings taken with cylindrical and conical BP cuffs|Single time point measurement (1 day)||||mm Hg||Standard Deviation|Mean
2535063|NCT03222414|Secondary|Mean of 2 Systolic Blood Pressure Readings Taken With Cylindrical and Conical BP Cuffs|mean of 2 systolic blood pressure readings taken with cylindrical and conical BP cuffs|Single time point measurement (1 day)||||mm Hg||Standard Deviation|Mean
2535064|NCT03222414|Secondary|Comparison of Noninvasive Diastolic Blood Pressure Readings to Invasive Blood Pressure Measurement|Absolute difference between the mean of 2 non-invasive diastolic blood pressure readings and mean of 2 invasive diastolic blood pressure readings|Single time point measurement (1 day)||||mm Hg|||Number
2535065|NCT03222414|Secondary|Comparison of Mean Arterial Pressure (MAP) Measured Withnon-invasive Cuffs to MAP Measured by Invasive Blood Pressure Monitoring|Absolute difference in the mean of 2 non-invasive MAP readings and mean of 2 invasive MAP readings|Single time point measurement (1 day)||||mm Hg|||Number
2535066|NCT03222414|Primary|Comparison of Noninvasive Systolic Blood Pressure Readings to Invasive Blood Pressure Measurement|Absolute difference between the mean of 2 non-invasive systolic blood pressure readings and mean of 2 invasive systolic blood pressure readings|Single time point measurement (1 day)||||mm Hg|||Number
2535067|NCT03222141|Secondary|Number of Participants With Aortic Insufficiency at 30 Days|The proportion of patients with aortic insufficiency ≥ moderate at 30 days.|30 Days|Echo data was available only for 532 patients.|||Participants|||Count of Participants
2535068|NCT03222141|Secondary|Number of Participants With Major Vascular Complications|The rate of major vascular complications at 30 days post implantation|30 Days||||Participants|||Count of Participants
2535072|NCT03222037|Secondary|Area Under Contrast Sensitivity Function Curve|Contrast sensitivity was assessed in both eyes at 1.5, 3.0, 6.0, 12.5 and 18.0 cycles per degrees (cpd) using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patients responses using the remote (Android Tablet). After a testing session had been completed the software calculated the Area under the log contrast sensitivity function from 1.5 cpd to 18 cpd.|15 minutes post treatment administration|All subjects who completed all study visits without a major protocol deviation.|||log|Eyes|Standard Deviation|Mean
2535073|NCT03222037|Primary|Visual Acuity (logMAR)|Visual Acuity was collected electronically under two conditions (high luminance low contrast and low luminance high contrast) in both eyes 15- minutes post study article administration. The average visual acuity for each lens type and condition was reported.|15 Minutes post Treatment Administration|Subjects that completed all study visits without a major protocol deviation.|||logMAR|Eyes|Standard Deviation|Mean
2535074|NCT03221738|Secondary|Yale Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS). This Measure Will be Used to Assess Change Over the Course of Treatment at Five Time Points Throughout the Study (Over Approximately 10 Months Total).|The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess change in BDD symptoms from baseline to endpoint.|Post-treatment assessment (week 12)||||score on a scale||Standard Deviation|Mean
2535075|NCT03221738|Primary|Client Satisfaction Questionnaire (CSQ). This Measure Will be Used to Assess Change Over the Course of Treatment Twice Throughout the Study (Over Approximately 10 Months Total).|The Client Satisfaction Questionnaire (CSQ) is a 25-item self-report questionnaire which assesses the satisfaction with clinical services received. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.|Post-treatment assessment (week 12)||||score on a scale||Standard Deviation|Mean
2535076|NCT03221738|Primary|Treatment Completion Rates|Number of subjects who completed the app-based treatment to assess feasibility and acceptability|Post treatment assessment (12 weeks)||||Participants|||Count of Participants
2535077|NCT03221192|Secondary|Number of Participants Reporting Treatment Impacts as Identified During the App Task|Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting treatment impacts as identified during app task is reported.|Up to 10 days|All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.|||Participants|||Count of Participants
2535078|NCT03221192|Secondary|Number of Participants Reporting Work Impacts as Identified During the App Task|Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting work impacts as identified during app task is reported.|Up to 10 days|All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.|||Participants|||Count of Participants
2535079|NCT03221192|Secondary|Number of Participants Reporting Social Functioning Impacts as Identified During the App Task|Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting social functioning impacts as identified during app task is reported.|Up to 10 days|All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.|||Participants|||Count of Participants
2535080|NCT03221192|Secondary|Number of Participants Reporting Emotional Impacts as Identified During the App Task|Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting emotional impacts as identified during app task is reported.|Up to 10 days|All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.|||Participants|||Count of Participants
2535081|NCT03221192|Secondary|Number of Participants Reporting ADL Impacts as Identified During the App Task|Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting ADL impacts as identified during app task is reported.|Up to 10 days|All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.|||Participants|||Count of Participants
2535173|NCT03217968|Primary|Pain Freedom (PF) at 2 Hours|The percentage of patients having a reduction of a moderate or severe migraine headache (Grade 2 or 3) at baseline to no headache (Grade 0) at 2 hours after the beginning of the e-TNS session.|2 hours||||Participants|||Count of Participants
2535082|NCT03221192|Secondary|Number of Participants Reporting Sleep Impacts as Identified During the App Task|Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting sleep impacts as identified during app task is reported.|Up to 10 days|All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.|||Participants|||Count of Participants
2535083|NCT03221192|Secondary|Number of Participants Reporting Physical Impacts as Idenfied During the App Task|Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants with physical impacts as identified during app task is reported.|Up to 10 days|All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.|||Participants|||Count of Participants
2535084|NCT03221192|Secondary|Number of Participants Reporting Secondary Symptoms as Identified During App Task|Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting secondary symptoms as identified during app task is reported.|Up to 10 days|All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.|||Participants|||Count of Participants
2535085|NCT03221192|Secondary|Number of Participants Reporting Primary Symptoms as Identified During App Task|Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Number of participants reporting primary symptoms as identified during app task is reported.|Up to 10 days|All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.|||Participants|||Count of Participants
2535086|NCT03221192|Secondary|Number of Participants Reporting Symptom Variability-Application (App) Task|Participants took part in an app-based real-world data capture activity. The participants were required to download an app to their smart phone or tablet. Data capture was conducted over a 10-day period during which participants were required to complete a series of questions/tasks via the smartphone/tablet application in real-time. The questions/tasks were designed to explore the experience of nasal polyps. Participants provided responses to the questions using a variety of methodologies including video, audio, text and photographic responses with captions. Participants completed a number of tasks across 10 days, which explored how nasal polyp symptoms and impacts varied across a full day (within day variability) or assess the day to day variability (between day variability). Number of participants reporting within day and between-day symptom variability is reported.|Up to 10 days|All Enrolled Population. Only those participants who took part in the real-world data capture activity were included in the analysis.|||Participants|||Count of Participants
2535087|NCT03221192|Primary|Number of Participants Who Reported Missing SNOT-22 Items|Participants completed SNOT-22 as a part of the CD interview. The SNOT-22 contains 22 nose, sinus, and general HRQoL items and is used to measure health-related quality of life associated with rhinosinusitis with or without nasal polyps. Within the SNOT-22, participants were required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be). Participants were asked if they felt any items were missing from SNOT-22. Number of participants who reported missing items in SNOT-22 is presented.|Up to 120 minutes|All Enrolled Population. Only those participants who were asked about missing items were included in the analysis.|||Participants|||Count of Participants
2535088|NCT03221192|Primary|Number of Participants Who Understood SNOT-22 Response Options|Participants completed SNOT-22 as a part of the CD interview. The SNOT-22 contains 22 nose, sinus, and general HRQoL items and is used to measure health-related quality of life associated with rhinosinusitis with or without nasal polyps. Within the SNOT-22, participants were required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be). Participants were asked about their understanding of each of the six options (no problem, mild or slight problem, very mild problem, moderate problem, severe problem, as bad as it can be) included in SNOT-22. Number of participants who understood each of the six SNOT-22 response options is presented.|Up to 120 minutes|All Enrolled Population|||Participants|||Count of Participants
2535089|NCT03221192|Primary|Number of Participants With Difficulties Completing SNOT-22|Participants provided a general feedback on completing the SNOT-22 during the CD interview. The SNOT-22 contains 22 nose, sinus, and general HRQoL items and is used to measure health-related quality of life associated with rhinosinusitis with or without nasal polyps. Within the SNOT-22, participants were required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be). Number of participants with difficulties completing SNOT-22 assessment is presented.|Up to 120 minutes|All Enrolled Population. Only those participants who were interviewed for ease of completion were included in the analysis.|||Participants|||Count of Participants
2535090|NCT03221192|Primary|Number of Participants Who Liked or Disliked SNOT-22 Assessments|The SNOT-22 contains 22 nose, sinus, and general HRQoL items and is used to measure health-related quality of life associated with rhinosinusitis with or without nasal polyps. Within the SNOT-22, participants were required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be). Participants provided a general feedback on completing the SNOT-22 which included relevance of symptoms to their condition, ease of completion and interpretation of the scale. Number of participants who liked or disliked the SNOT-22 is presented.|Up to 120 minutes|All Enrolled Population. Only those participants who provided general feedback were included in the analysis.|||Participants|||Count of Participants
2535091|NCT03221192|Primary|Number of Participants Who Reported Symptoms Assessed by SNOT-22 as Relevant to Their Condition|Participants were required to complete SNOT-22 assessment as a part of the CD interview. The SNOT-22 contains 22 nose, sinus, and general HRQoL items and is used to measure health-related quality of life associated with rhinosinusitis with or without nasal polyps. Within the SNOT-22, participants were required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be). Number of participants who reported the symptoms assessed by SNOT-22 to be relevant to their condition are presented.|Up to 120 minutes|All Enrolled Population. Only those participants who were asked about each item was analyzed (represented by n=X in category titles)|||Participants|||Count of Participants
2535092|NCT03221192|Primary|Number of Participants Who Did Not Understand the Items of Sino-nasal Outcomes Test (SNOT)-22|Participants completed SNOT-22 assessment as a part of the CD interview. The SNOT-22 contains 22 nose, sinus, and general health-related quality of life (HRQoL) items and is used to measure HRQoL associated with rhinosinusitis with or without nasal polyps. Within the SNOT-22, participants were required to indicate the level to which each listed nasal, sinus or HRQoL experience has been affected on a 6-point scale ranging from 0 (No problem) to 5 (Problem as bad as it can be). Number of participants who did not understand the items of SNOT-22 is presented.|Up to 120 minutes|All Enrolled Population. Only those participants who were asked about each item was analyzed (represented by n=X in category titles)|||Participants|||Count of Participants
2535093|NCT03221192|Primary|Number of Participants Who Understood VAS Anchors|Participants completed the VAS assessment as a part of the CD interview. Participants evaluated their overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 cm or 100 mm whereby 0 represents 'no symptom' and 10 or 100 represents 'as bad as you can imagine' respectively. Participants were asked about their understanding of the response continuum for VAS assessment. Number of participants who understood the VAS anchors (100 as bad as you can imagine and 0 none) is presented.|Up to 120 minutes|All Enrolled Population. Only those participants with data available at the specified time points were included in the analysis (indicated by n=X in category titles)|||Participants|||Count of Participants
2535094|NCT03221192|Primary|Number of Participants With Difficulties Completing VAS Assessments|Participants were required to complete six VAS assessments (overall symptom VAS and single item VAS) as a part of the CD interview. The participants evaluated their overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 cm or 100 mm whereby 0 represents 'no symptom' and 10 or 100 represents 'as bad as you can imagine' respectively. Participants provided a general feedback on completing the six VAS assessments which included relevance of symptoms to their condition, ease of completion and interpretation of the scale. The number of participants with difficulties completing VAS assessment is presented.|Up to 120 minutes|All Enrolled Population. Only those participants who provided general feedback were included in the analysis.|||Participants|||Count of Participants
2535095|NCT03221192|Primary|Number of Participants Who Liked or Disliked VAS Assessments|Participants were required to complete six VAS assessments (overall symptom VAS and single item VAS) as a part of the CD interview. The participants evaluated their overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 cm or 100 mm whereby 0 represents 'no symptom' and 10 or 100 represents 'as bad as you can imagine' respectively. Participants provided a general feedback on completing the six VAS assessments which included relevance of symptoms to their condition, ease of completion and interpretation of the scale. The number of participants who provided general feedback for VAS assessments in terms of likes or dislikes for VAS assessment is presented.|Up to 120 minutes|All Enrolled Population. Only those participants who provided general feedback were included in the analysis.|||Participants|||Count of Participants
2535096|NCT03221192|Primary|Number of Participants Who Reported Symptoms Assessed by VAS to be Relevant to Their Condition|Participants were required to complete six VAS assessments (overall symptom VAS and single item VAS) as a part of the CD interview. The participants evaluated their overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 cm or 100 mm whereby 0 represents 'no symptom' and 10 or 100 represents 'as bad as you can imagine' respectively. Participants were asked to speak aloud their thoughts as they read the instructions and completed the questions. After completion of each think-aloud exercise, participants were also probed about the relevance of VAS items. Relevance was determined based on participants personal descriptions and related discussion of their experience of each symptom or impact during CD interview. It was also determined via the rating of a given symptom/impact on each measure as greater than a score of zero. Number of participants who reported the symptoms assessed by VAS to be relevant are presented.|Up to 120 minutes|All Enrolled Population|||Participants|||Count of Participants
2535097|NCT03221192|Primary|Number of Participants Who Did Not Understand Visual Analog Scale (VAS) Assessment|Participants were required to complete six VAS assessments (overall symptom VAS and single item VAS) as a part of the CD interview. The participants evaluated their overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 centimeter (cm) or 100 millimeter (mm) whereby 0 represents 'no symptom' and 10 or 100 represents 'as bad as you can imagine' respectively. Participants were asked to speak aloud their thoughts as they read the instructions and completed the questions. After completion of each think-aloud exercise, participants were also probed upon their understanding of the instrument items. Number of participants who did not understand the VAS assessments is reported.|Up to 120 minutes|All Enrolled Population|||Participants|||Count of Participants
2545581|NCT02940327|Primary|CD64/163|Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.|72 hours after ECMO commencement||||percentage change||Standard Deviation|Mean
2535100|NCT03221192|Primary|Number of Participants Reporting Factors to be Considered for Surgery|During CE interviews, participants were asked about experiences of their surgery in past. The number of participants with the corresponding factors to be considered for surgery is presented.|Up to 120 minutes|All Enrolled Population. Only those participants who discussed the factors were included in the analysis.|||Participants|||Count of Participants
2535101|NCT03221192|Primary|Number of Participant Who Reported Impacts to be Targeted by New Treatment|During CE interviews, participants were asked about the changes they would like to see from a new treatment for nasal polyps and which impacts would be most meaningful for the treatment to target. The number of participants with corresponding impacts to be targeted by new treatment is presented.|Up to 120 minutes|All Enrolled Population. Only those participants who were asked about treatment preferences were included.|||Participants|||Count of Participants
2535102|NCT03221192|Primary|Number of Participants Who Reported Symptoms to be Targeted by New Treatment|During CE interviews, participants were asked about the changes they would like to see from a new treatment for nasal polyps and which symptoms would be most meaningful for the treatment to target. The number of participants with their reported symptoms to be targeted by new treatment is presented.|Up to 120 minutes|All Enrolled Population. Only those participants who were asked about treatment preferences were included.|||Participants|||Count of Participants
2535103|NCT03221192|Primary|Number of Participants Reporting Distal Impacts-treatment Impact|The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Distal impacts were those reported to be impacts of the condition as a whole and included; emotional, social, work/school and treatment impacts. The number of participants with treatment impacts are reported.|Up to 120 minutes|All Enrolled Population|||Participants|||Count of Participants
2535104|NCT03221192|Primary|Number of Participants Reporting Distal Impacts-work/School Impact|The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Distal impacts were those reported to be impacts of the condition as a whole and included; emotional, social, work/school and treatment impacts. The number of participants with work/school impacts are reported.|Up to 120 minutes|All Enrolled Population|||Participants|||Count of Participants
2535105|NCT03221192|Primary|Number of Participants Reporting Distal Impacts-social Impact|The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Distal impacts were those reported to be impacts of the condition as a whole and included; emotional, social, work/school and treatment impacts. The number of participants with social impacts are reported.|Up to 120 minutes|All Enrolled Population|||Participants|||Count of Participants
2535106|NCT03221192|Primary|Number of Participants Reporting Distal Impacts-emotional Impact|The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Distal impacts were those reported to be impacts of the condition as a whole and included; emotional, social, work/school and treatment impacts. The number of participants with emotional impacts are reported.|Up to 120 minutes|All Enrolled Population|||Participants|||Count of Participants
2535107|NCT03221192|Primary|Number of Participants Reporting Proximal Impacts-ADL Impact|The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Proximal impacts were defined as those reported to be the direct impact of the symptoms of nasal polyps and included; physical impacts, sleep impacts and impacts on ADL. The number of participants with ADL impacts are reported.|Up to 120 minutes|All Enrolled Population|||Participants|||Count of Participants
2535108|NCT03221192|Primary|Number of Participants Reporting Proximal Impacts-Sleep Impact|The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Proximal impacts were defined as those reported to be the direct impact of the symptoms of nasal polyps and included; physical impacts, sleep impacts and impacts on ADL. The number of participants with sleep impacts are reported.|Up to 120 minutes|All Enrolled Population|||Participants|||Count of Participants
2535109|NCT03221192|Primary|Number of Participants Reporting Proximal Impacts-Physical Impact|The impacts as reported by participants during CE interviews were categorized as proximal impacts and distal impacts. Proximal impacts were defined as those reported to be the direct impact of the symptoms of nasal polyps and included; physical impacts, sleep impacts and impacts on activities of daily living (ADL). The number of participants with physical impacts are reported.|Up to 120 minutes|All Enrolled Population|||Participants|||Count of Participants
2535110|NCT03221192|Primary|Number of Participants Who Reported Worst, Most-frequent and Most-bothersome Symptoms|Following spontaneous and probed discussions regarding symptoms during CE interviews, participants were asked to comment on what they each considered to be their 'worst' symptom, their 'most frequent' symptom and their 'most bothersome' symptom. The interviews were transcribed/translated verbatim and qualitative analysis was conducted using Atlas Ti. The number of participants with worst, most-frequent and most-bothersome symptoms are presented.|Up to 120 minutes|All Enrolled Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2535111|NCT03221192|Primary|Number of Participants Who Reported Secondary Symptoms|During the CE section of the interview, participants were asked a series of broad open-ended questions designed to encourage them to talk openly and as spontaneously as possible about their experience of having nasal polyps. In addition, participants were asked more focused questions designed to probe on issues that they may not have mentioned during the course of the interview spontaneously or concepts/statements that required additional clarification. The interviews were transcribed/translated verbatim and qualitative analysis was conducted using Atlas Ti. The symptoms that were reported by fewer participants and less frequently mentioned spontaneously by participants during the interviews were classified as secondary symptoms. Number of participants who reported each of the secondary symptoms is reported.|Up to 120 minutes|All Enrolled Population|||Participants|||Count of Participants
2535124|NCT03220204|Secondary|Change in Physical Activity|Assessed by ActiGraph GT3X+ step counters which are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. We will measure both number of steps per day (primary physical health outcome). Change scores will be calculated by subtracting the number of steps per day at baseline from number of steps per day at 12 weeks and 24 weeks.|Baseline, 12 weeks, and 24 weeks|Not all participants provided wore Actigraph GT3X+ step counters or provided follow-up data at both timepoints.|||steps/day||Standard Deviation|Mean
2535112|NCT03221192|Primary|Number of Participants Who Reported Primary Symptoms|During the CE section of the interview, participants were asked a series of broad open-ended questions designed to encourage them to talk openly and as spontaneously as possible about their experience of having nasal polyps. In addition, participants were asked more focused questions designed to probe on issues that they may not have mentioned during the course of the interview spontaneously or concepts/statements that required additional clarification. The interviews were transcribed/translated verbatim and qualitative analysis was conducted using Atlas Ti. The symptoms which were most frequently reported spontaneously and were also reported to either be the most frequent, bothersome or worst were categorized as primary symptoms. Number of participants who reported each of the primary symptom is presented.|Up to 120 minutes|All Enrolled Population included all participants with severe, recurrent nasal polyps enrolled in the study|||Participants|||Count of Participants
2535113|NCT03220412|Primary|Seconds Holding Gun|Number of seconds participant held gun|20 minutes after intervention||||seconds||95% Confidence Interval|Mean
2535114|NCT03220412|Primary|Trigger Pulls|The adjusted median of the number of trigger pulls per child. These data refer to the reduced Generalized Estimating Equation model for the two conditions. This model included participant gender and condition, bu not any of the other control variables.|20 minutes after intervention||||Number of trigger pulls||95% Confidence Interval|Median
2535115|NCT03220230|Secondary|Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender and Age|In this outcome measure, participants were categorized according to their gender (female/male) and different age ranges (18-30 / 31-40 / 41-60 / 60 and above).|40 months|"Per protocol analysis set included all participants with valid IHC-Ventana and NGS-OFA results. Here, Overall Number of Participants Analyzed participants evaluable for this outcome measure."|||Participants|||Count of Participants
2535116|NCT03220230|Secondary|Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Location|Locations were categorized as lungs, pleura, node mediastinal and others.|40 months|"Per protocol analysis set included all participants with valid IHC-Ventana and NGS-OFA results. Here, Overall Number of Participants Analyzed participants evaluable for this outcome measure."|||Participants|||Count of Participants
2535117|NCT03220230|Secondary|Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Stage and Classification of Biopsy|Stage was defined at time of initial diagnosis of NSCLC and participants were staged according to the guidelines set by the NCCN version 7.2015. Participant's stage was categorized as: stage 0, stage IA, stage IB, stage IIA, stage IIB, stage IIIA, stage IIIB, and stage IV. Biopsy NSCLC class was categorized as adenocarcinoma, neuroendocrine tumors, other known type of NSCLC and squamous cell carcinoma.|40 months|"Per protocol analysis set included all participants with valid IHC-Ventana and NGS-OFA results. Here, Overall Number of Participants Analyzed participants evaluable for this outcome measure."|||Participants|||Count of Participants
2535118|NCT03220230|Secondary|Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking (Tobacco Use) History|The categories of smoker (tobacco use) were as follows: Never Smoker: No smoking exposure, Current Smoker: Currently uses tobacco in either cigarette, cigar or similar method (tobacco chewers excluded), Former Smoker: Participant at one time smoked but then later quit. Smoking status unknown: Participant whose smoking status is unknown.|40 months|"Per protocol analysis set included all participants with valid IHC-Ventana and NGS-OFA results. Here, Overall Number of Participants Analyzed participants evaluable for this outcome measure."|||Participants|||Count of Participants
2535119|NCT03220230|Secondary|Number of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Biomarker by Type of Participants|Participants were categorized on the basis of prospective and retrospective. Prospective participants were those participants whose samples were taken after the informed consent. Retrospective participants were those participants whose samples were taken before the date of signature of the informed consent.|40 months|"Per protocol analysis set included all participants with valid IHC-Ventana and NGS-OFA results. Here, Overall Number of Participants Analyzed participants evaluable for this outcome measure."|||Participants|||Count of Participants
2535120|NCT03220230|Primary|Percentage of Concordance (Agreement) Between Ventana and NGS ALK Result|In this outcome measure, index of concordance with accuracy, sensitivity, specificity, positive predictive value and negative predictive value were measured. Accuracy (Acc): [tp+tn]/[tp+fp+fn+tn] *100; Sensitivity (Ss): tp/[tp+fn] *100; Specificity (Sp): tn/[fp+tn] *100; Positive Predictive Value (PPV): tp/[tp+fp] *100; Negative Predictive Value (NPV): tn/[fn+tn] *100.|40 months|Per protocol analysis set included all participants with valid IHC-Ventana and NGS-OFA results. Here, “Number analyzed” signifies the number of participants evaluable at specific rows.|||percentage of concordance||95% Confidence Interval|Number
2535121|NCT03220230|Primary|Number of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Biomarker|ALK status was measured by NGS- Oncomine focus assay (OFA) and Immuno histo chemistry (IHC) Ventana. Ventana -ALK and NGS-OFA were the assay procedures performed for ALK. The corresponding analysis of a specimen had 2 possible test results including ALK positive and ALK negative. True positives (tp) were defined as NGS-OFA and Ventana positive results, whereas false negatives (fn) were defined as NGS-OFA negative results and IHC-Ventana positive results. False positives (fp) were defined as NGS-OFA positive results and IHC-Ventana negative results. True negatives (tn) were defined as NGS-OFA and IHC Ventana negative results.|40 months|Per protocol analysis set included all participants with valid IHC-Ventana and NGS-OFA results.|||Participants|||Count of Participants
2535122|NCT03220204|Secondary|Feasibility of Actigraph|Feasibility will be measured by examining the number of participants who provide adequate Actigraph data, defined in this study as at least 480 minutes for 5 days, at each time point.|Baseline, 12 weeks and 24 weeks|Not all participants provided wore Actigraph GT3X+ step counters or provided follow-up data at both timepoints.|||Participants with adequate activity data|||Number
2535123|NCT03220204|Secondary|Change in Moderate to Vigorous Physical Activity|Assessed with ActiGraph GT3X+ step counters, which are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. Change was calculated by subtracting the MVPA at baseline from the MVPA at 12 weeks and 24 weeks.|Baseline, 12 weeks, and 24 weeks|Not all participants provided wore Actigraph GT3X+ step counters or provided follow-up data at both timepoints.|||minutes/day||Standard Deviation|Mean
2535125|NCT03220204|Secondary|Changes in Self-Reported Medication Adherence (SRMA)|The Self-Reported Medication Adherence (SRMA) asks what percent of the time (in 10% increments) participants took all of their medications as prescribed in the past week and in the past 2 weeks (Range: 0-100). Change was calculated by subtracting the score at baseline from the score at 10 weeks.|Baseline, 12 weeks and 24 weeks|Not all participants provided follow-up data at both timepoints.|||percentage of time||Standard Deviation|Mean
2535126|NCT03220204|Secondary|Changes in Sodium Intake (as Measured With the SSQ)|"The Scored Sodium Questionnaire (SSQ) is a self-report scale that assesses the frequency with which participants consume a variety of sodium-containing foods, ranging from Rarely or Never Eaten to At Least Once Daily. It is used to calculate daily sodium intake (Range: 0-215). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate higher sodium intake."|Baseline, 12 weeks, and 24 weeks|Not all participants provided follow-up data at both timepoints.|||units on a scale||Standard Deviation|Mean
2535127|NCT03220204|Secondary|Changes in MOS SAS Scores|Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score (Range: 3-18). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate better adherence to health behaviors.|Baseline, 12 weeks, and 24 weeks|Not all participants provided follow-up data at both timepoints.|||units on a scale||Standard Deviation|Mean
2535128|NCT03220204|Secondary|Changes in SF-12 Scores|The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate higher level of health related QoL.|Baseline, 12 weeks, and 24 weeks|Not all participants provided follow-up data at both timepoints.|||units on a scale||Standard Deviation|Mean
2535129|NCT03220204|Secondary|Changes in KCCQ Scores (Primary Functional Outcome)|The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated questionnaire of health status in HF. The full scale will be used to measure HF-specific health-related QoL (HRQoL), and an eight-question subset of the KCCQ will be used as a measure of HF symptoms (QoL score range: 0-100; total symptom score range: 0-100). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher QoL scores indicate better HF specific health-related QoL, and higher total symptom scores indicate fewer symptoms.|Baseline, 12 weeks, and 24 weeks|Not all participants provided follow-up data at both timepoints.|||units on a scale||Standard Deviation|Mean
2535130|NCT03220204|Secondary|Change in HADS-Depression Subscale Scores|The Hospital Anxiety and Depression Scale (HADS)-depression subscale was be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate higher levels of depression.|Baseline, 12 weeks, and 24 weeks|Not all participants provided follow-up data at both timepoints.|||units on a scale||Standard Deviation|Mean
2535131|NCT03220204|Secondary|Changes in HADS-Anxiety Subscale Scores|The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale was be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher scores indicate higher levels of anxiety.|Baseline, 12 weeks, and 24 weeks|Not all participants provided follow-up data at both timepoints.|||units on a scale||Standard Deviation|Mean
2535132|NCT03220204|Secondary|Changes in SOM Scores|The State Optimism Measure (SOM) will be used to measure state optimism (Range: 7-35). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of state optimism.|Baseline, 12 weeks, and 24 weeks|Not all participants provided follow-up data at both timepoints.|||units on a scale||Standard Deviation|Mean
2535133|NCT03220204|Secondary|Changes in LOT-R Scores|Life Orientation Test-Revised (LOT-R) is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of dispositional optimism.|Baseline, 12 weeks, and 24 weeks|Not all participants provided follow-up data at both timepoints.|||units on a scale||Standard Deviation|Mean
2535134|NCT03220204|Secondary|Change in PANAS Scores (Primary Psychological Outcome)|The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with HF, will be used to measure positive affect (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of positive affect.|Baseline, 12 weeks, and 24 weeks|Not all participants provided follow-up data at both timepoints.|||units on a scale||Standard Deviation|Mean
2535135|NCT03220204|Secondary|Immediate Impact of the Exercises|Participants receiving the PP-based health behavior intervention will provide ratings of optimism and positive affect, before and after each exercise, measured on a 10-point Likert scale.|Weekly, up to 12 weeks||||units on a scale||Standard Deviation|Mean
2535136|NCT03220204|Secondary|Acceptability of the Exercises|Participants receiving the PP-based health behavior intervention will provide ratings of ease and utility after each exercise, measured on a 10-point Likert scale.|12 weeks||||rating out of 10||Standard Deviation|Mean
2535137|NCT03220204|Primary|Feasibility of the PP-based Health Behavior Intervention|Feasibility will be measured by examining the number of completed exercises for individuals randomized to the Positive Psychology (PP)-based intervention.|Change between baseline and 12 weeks||||sessions completed out of 12 sessions||Standard Deviation|Mean
2535138|NCT03220048|Secondary|Secondary Efficacy Endpoint: Total Weight of Nasal Discharge Produced Post Viral Challenge to Quarantine Discharge|Total weight of nasal discharge (in grams) was calculated as the sum of mucus weights taken from Day 1 (Post viral challenge) to Day 8 (Quarantine Discharge).|8 days||||grams||Standard Deviation|Mean
2535139|NCT03220048|Secondary|Secondary Efficacy Endpoint: Viral Load Parameters: Area Under the Curve (AUC) of Viral Load, as Measured by Nasopharyngeal Swab RT-qPCR.|Viral load data was supplied in Log10 Copies/mL. These values were used to calculate the Area Under the Curve (AUC) of Viral Load for each subject.|8 days||||mins*log10 copy number/mL||Standard Deviation|Mean
2535142|NCT03220048|Secondary|Secondary Efficacy Endpoint: Symptom Scores: Peak Symptoms Score|"Using the scheduled protocol assessments from Day 1 to Day 8, this endpoint represented the highest total symptom score (defined as the sum of all 10 individual composite symptoms).~The minimum value, for subjects who had no symptoms, would be 0. The maximum value would be 30.~Higher scores indicate worse outcome than lower scores."|8 days||||Score||Standard Deviation|Mean
2535143|NCT03220048|Primary|Primary Efficacy Endpoint: The Area Under the Curve (AUC) of Total Symptom Score From Day 1 (Post Viral Challenge) to Day 8 (Quarantine Discharge).|"Area Under the Curve (AUC) of total symptom scores (upper respiratory tract (URT), lower respiratory tract (LRT) and systemic viral symptoms (SVS)). Total symptom scores (from the symptom diary card) were used to calculate the AUC. The time unit used was minutes. Thus, the AUC unit is the total symptom score multiplied by the time period from first to last assessment in minutes (i.e score*mins).~The minimum AUC value would be 0, for a subject who did not report any symptoms. The maximum AUC value is not provided as it would be theoretical only, with no real meaning in terms of severity.~Higher scores indicate worse outcome than lower scores."|8 days||||score*mins||Standard Deviation|Mean
2535144|NCT03219723|Secondary|H. Pylori Eradication Rate|In participants who were determined as achieving H. pylori eradication, the percentage of participants negative for H. pylori (eradication rates) was tabulated by first-line eradication and second-line eradication. Timeframe was defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration).|7 days + 2 months|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||Percent||95% Confidence Interval|Number
2535145|NCT03219723|Primary|Percentage of Participants Who Had One or More Adverse Drug Reactions|Adverse drug reaction refers to adverse events related to administered drug. Timeframe was defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration).|Up to 7 days and 2 months|Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.|||Percentage of Participants|||Number
2535146|NCT03219294|Secondary|Duration of Surgery|Time from incision to joint reduction|Through study completion, an average of 24 hours for each patient and up to one year for the whole study.||||minutes||Standard Deviation|Mean
2535147|NCT03219294|Primary|Surgical Conditions|The surgeon graded the overall surgical conditions on a 5 point Likert scale, that was taken into account along with requests for additional muscle relaxation. The Likert scale went from 1 (extremely poor conditions: muscles resistant to retraction and obscure view, implant difficult to insert into socket, requires assist) to 5 (optimal conditions: muscles relaxed, excellent view, implant easy to insert).|Through study completion, an average of 24 hours.||||Participants|||Count of Participants
2535148|NCT03219216|Secondary|Percentage of Participants With Post-treatment HCV Virologic Relapse|Post-treatment HCV virologic relapse was defined as confirmed HCV RNA ≥ 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA levels < 15 IU/mL at the end of treatment and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed.|From the end of treatment (8 or 12 weeks depending on treatment regimen) through 12 weeks after the last dose of study drug|All enrolled participants who received at least 1 dose of study drug and who completed treatment, had HCV RNA < 15 IU/mL at final treatment visit, and had at least one post-treatment HCV RNA value. Data are reported for the overall study population according to the prespecified analysis plan for this study.|||percentage of participants||95% Confidence Interval|Number
2535149|NCT03219216|Secondary|Percentage of Participants With On-treatment HCV Virologic Failure|"On-treatment HCV virologic failure was defined as one of the following:~Confirmed hepatitis C virus ribonucleic acid (HCV RNA) ≥ 100 IU/mL after HCV RNA < 15 IU/mL at any time point during treatment; or~Confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) during study drug treatment; or~HCV RNA ≥ 15 IU/mL at the end of treatment with at least 6 weeks of treatment."|8 or 12 weeks (depending on treatment regimen)|All enrolled participants who received at least 1 dose of study drug. Data are reported for the overall study population according to the prespecified analysis plan for this study.|||percentage of participants||95% Confidence Interval|Number
2535150|NCT03219216|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last dose of study drug.|12 weeks after last dose of study drug (week 20 or 24 depending on treatment regimen)|All enrolled participants who received at least one dose of study drug. Backward imputation, where applicable, was used to impute missing data. Participants with missing data after backward imputation were counted as non-responders. Data are reported for the overall study population according to the prespecified analysis plan for this study.|||percentage of participants||95% Confidence Interval|Number
2535151|NCT03218592|Secondary|Whole Blood Antiretroviral Concentrations|Concentrations will be measured in dried blood spots of all study drugs, inclusive of FTC (emtricitabine), TFV (tenofovir), MRV (Maraviroc), and DTG (dolutegravir). Truvada is a combination pill, so results for both FTC and TFV are reported in separate columns.|Up to 28 days post-dose|3 drug arms, but Truvada is inclusive of both TFV/FTC so reported here separately|||fmol / 3mm punch||Inter-Quartile Range|Median
2535152|NCT03218592|Secondary|Plasma Antiretroviral Concentrations|Concentrations will be measured in hair of all study drugs, inclusive of FTC (emtricitabine), TFV (tenofovir), MRV (Maraviroc), and DTG (dolutegravir)|Up to 28 days post-dose|3 drug arms, but Truvada is inclusive of both TFV-dp and FTC-tp|||ng/mL||Inter-Quartile Range|Median
2535153|NCT03218592|Secondary|Peripheral Blood Mononuclear Cells (PBMC) Antiretroviral Concentrations|Concentrations of emtricitabine-triphosphate, tenofovir-diphosphate will be measured in peripheral blood mononuclear cells in the Truvada arm only. Truvada is a combination pill, so results for both FTC and TFV are reported in separate columns.|Up to 28 days post-dose|PBMC Concentrations were analyzed in the Truvada arm only. Results are for emtricitabine-triphosphate.|||fmol/10^6 cells||Inter-Quartile Range|Median
2538041|NCT03116841|Secondary|Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)||Up to Week 8|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
2535154|NCT03218592|Primary|Hair Antiretroviral Imaging|Signal Strength concentrations will be measured in hair for all study drugs, inclusive of FTC (emtricitabine), tenofovir (TFV), maraviroc (MRV), and dolutegravir (DTG) using Matrix-assisted Laser Desorption Electrospray Ionization (IR-MALDESI) to be reported by signal abundance (au). Signal abundance is the industry standard unit, and higher values represent greater signal with capability to relate to comparative concentrations.|Up to 28 days post dose|In Phase 3, the 12 participants were divided into 3 dosing categories: either zero further doses,1 dose per week, or 3 doses per week. For the single dose Phase 1, signal abundance was not able to be observed consistently for all drug arms|||Signal Abundance (au)||Inter-Quartile Range|Median
2535155|NCT03218397|Secondary|Number of New Hospital-acquired Infections (HAIs) and/or Multidrug Resistant Organisms (MDROs), Normalized to 10,000 Patient-days.|"Acquisition of new hospital-acquired infections (HAIs) and/or multidrug resistant organisms (MDROs) within 30 days during index hospitalization identified on routine clinical or surveillance samples.~Cultures that will be tracked include the following, from any specimen source, unless otherwise indicated:~Methicillin-resistant Staphylococcus aureus~Vancomycin-resistant Enterococcus~3rd generation cephalosporin non-susceptible Enterobacteriaceae~Carbapenem-resistant Enterobacteriaceae, as defined by the Centers for Disease Control and Prevention (CDC): resistant to imipenem, meropenem, doripenem, or ertapenem OR documentation that the isolate possesses a carbapenemase~Multidrug-resistant Pseudomonas aeruginosa (resistant to aminoglycosides, cephalosporins, fluoroquinolones, and carbapenems)~Carbapenem-resistant Acinetobacter~Candida species (isolated from blood cultures only)"|Within 30 days of randomization|Subjects who completed the study.|||Infections per 10,000 patient-days||95% Confidence Interval|Number
2535156|NCT03218397|Secondary|Number of Hospital-onset Clostridium Difficile Infections|Acquisition of hospital-onset Clostridium difficile within 30 days, as defined by the National Healthcare Safety Network (NHSN), normalized to 10,000 patient-days.|Within 30 days of randomization|Subjects who completed the study.|||Infections per 10,000 patient-days||95% Confidence Interval|Number
2535157|NCT03218397|Secondary|Time to First Gram-positive Antibiotic De-escalation|Mean hours to first gram-positive antibiotic de-escalation within 72 hours from randomization, where de-escalation is defined as changing to a narrower spectrum antibiotic, cessation of one or more antibiotics, or changing from an intravenous to oral route of appropriate drug.|Within 72 hours of randomization|Subjects who completed the study.|||hours||Standard Deviation|Mean
2535158|NCT03218397|Secondary|Time to First Gram-negative Antibiotic De-escalation|Mean hours to first gram-negative antibiotic de-escalation within 72 hours from randomization, where de-escalation is defined as changing to a narrower spectrum antibiotic, cessation of one or more antibiotics, or changing from an intravenous to oral route of appropriate drug.|Within 72 hours of randomization|Subjects who completed the study.|||hours||Standard Deviation|Mean
2535159|NCT03218397|Secondary|Time to First Antibiotic De-escalation|Mean hours to first antibiotic de-escalation within 72 hours from randomization, where de-escalation is defined as changing to a narrower spectrum antibiotic, cessation of one or more antibiotics, or changing from an intravenous to oral route of appropriate drug.|Within 72 hours of randomization|Subjects who completed the study.|||hours||Standard Deviation|Mean
2535160|NCT03218397|Secondary|Time to First Gram-positive Antibiotic Escalation|Mean hours to first gram-positive antibiotic escalation within 72 hours from randomization, where escalation is defined as changing to a broader spectrum antibiotic, addition of one or more antibiotics, or conversion of oral to intravenous route.|Within 72 hours of randomization|Subjects who completed the study.|||hours||Standard Deviation|Mean
2535161|NCT03218397|Secondary|Time to First Gram-negative Antibiotic Escalation|Mean hours to first gram-negative antibiotic escalation within 72 hours from randomization, where escalation is defined as changing to a broader spectrum antibiotic, addition of one or more antibiotics, or conversion of oral to intravenous route.|Within 72 hours of randomization|Subjects who completed the study.|||hours||Standard Deviation|Mean
2535162|NCT03218397|Secondary|Time to First Antibiotic Escalation|Mean hours to first antibiotic escalation within 72 hours from randomization, where escalation is defined as changing to a broader spectrum antibiotic, addition of one or more antibiotics, or conversion of oral to intravenous route.|Within 72 hours of randomization|Subjects who completed the study.|||hours||Standard Deviation|Mean
2535163|NCT03218397|Secondary|ICU Status Through 72 Hours Post-randomization|ICU status through 72 hours post-randomization|Within 72 hours of randomization|Subjects who completed the study.|||Participants|||Count of Participants
2535164|NCT03218397|Secondary|Length of Stay in the Hospital|Length of stay in the hospital after randomization, up to 30 days, for patients alive at 30 days. Length of stay will be date of discharge minus date of randomization.|Within 30 days of randomization|Subjects who were alive at 30 days.|||days||Standard Deviation|Mean
2535165|NCT03218397|Secondary|Subjects Who Experienced Mortality Within 30 Days of Randomization|Subjects who experienced mortality within 30 days of randomization|Within 30 days of randomization|Subjects who completed the study.|||Participants|||Count of Participants
2535166|NCT03218397|Primary|Hours to First Antibiotic Modification|Mean hours until first modification of antibiotic therapy within 72 hours post randomization|72 hours after randomization|Subjects who completed the study.|||hours||Standard Deviation|Mean
2535167|NCT03218163|Primary|Progression Free Survival|The progression free survival (PFS) of high-risk or relapsed multiple myeloma (MM) patients undergoing non-myeloablative bone marrow allogeneic transplantation (NM-AlloSCT) followed by maintenance therapy with MEDI-551.|5 years|The study was terminated before any participant could start the study and receive intervention. Therefore, no data could be collected.||||||
2535168|NCT03217968|Secondary|Sustained Pain Freedom at 24 Hours|The percentage of patients having no headache (Grade 0) at 2 hours, with no use of rescue medication and no relapse of headache pain within the 24 hours after the beginning of the e-TNS session.|24 hours||||Participants|||Count of Participants
2535169|NCT03217968|Secondary|Use of Rescue Medication Between 2 and 24 Hours|The percentage of patients who took acute anti-migraine medication between 2 and 24 hours after the beginning of the e-TNS session.|Between 2 and 24 hours||||Participants|||Count of Participants
2535170|NCT03217968|Secondary|Migraine-associated Symptoms Freedom at 2 Hours|The percentage of patients with absence of photophobia, phonophobia, nausea and vomiting, at 2 hours after the beginning of the e-TNS session.|2 hours||||Participants|||Count of Participants
2535174|NCT03217175|Secondary|Time From Exercise Start to Plasma Glucose < 60 mg/dl|The time from the start of exercise to the first plasma glucose measurement < 60 mg/dl that is reached|1 day (last day of each study arm - exercise visit)|The study was terminated without performing any analysis of the data. The study was terminated because of a lack of appropriate funding.||||||
2535175|NCT03217175|Secondary|Area Over the Curve and < 60 mg/dl|The area over the plasma glucose curve but less than the 60 mg/dl threshold during exercise visit (a measure of hypoglycemic exposure)|1 day (last day of each study arm - exercise visit)|The study was terminated without performing any analysis of the data. The study was terminated because of a lack of appropriate funding.||||||
2535176|NCT03217175|Secondary|Nadir Plasma Glucose|The lowest plasma glucose experienced during the exercise visit|1 day (last day of each study arm - exercise visit)|The study was terminated without performing any analysis of the data. The study was terminated because of a lack of appropriate funding.||||||
2535177|NCT03217175|Secondary|Duration of Plasma Glucose < 60 mg/dl|The amount of time the subject's plasma glucose is less than 60 mg/dl during the exercise visit|1 day (last day of each study arm - exercise visit)|The study was terminated without performing any analysis of the data. The study was terminated because of a lack of appropriate funding.||||||
2535178|NCT03217175|Primary|Number of Subjects With Plasma Glucose < 60 mg/dl|Number of subjects discordant between insulin-only and bihormonal bionic pancreas visits for reaching plasma glucose less than 60 mg/dl for greater than 2 consecutive measurements|1 day (last day of each study arm - exercise visit)|The study was terminated without performing any analysis of the data. The study was terminated because of a lack of appropriate funding.||||||
2535179|NCT03216850|Primary|Endothelial Glycocalyx Thickness|Endothelial glycocalyx thickness was measured indirectly by PBR, which is a lateral movement of the red blood cells from the median column in the microcirculation in micrometers. The higher the PBR is the more damaged the endothelial glycocalyx is.|One week within the ICU care||||micrometer||Inter-Quartile Range|Median
2535180|NCT03216746|Primary|Knowledge Score|The knowledge score varied from 13 (five) to 0 (zero). Higher scores means better outcomes.|30 days||||score on a scale||Full Range|Median
2535181|NCT03216512|Primary|Change in CANTAB ADHD Battery - Rapid Visual Processing Task|"Compare change from Baseline scores on the Cambridge Automated Neuropsychological Test Battery (CANTAB) ADHD battery with noise cancelling headphones and sham-controls. Results are reported as change from Baseline for each of 4 components of the ADHD battery.~Rapid Visual Processing Task: no minimum and maximum values as values are number of correct hits; higher scores indicate better performance compared to Baseline"|Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)||||correct hits||Standard Deviation|Mean
2535182|NCT03216512|Primary|Change in CANTAB ADHD Battery - Stop Signal Reaction Time Task|"Compare change from Baseline scores on the Cambridge Automated Neuropsychological Test Battery (CANTAB) ADHD battery with noise cancelling headphones and sham-controls. Results are reported as change from Baseline for each of 4 components of the ADHD battery.~Stop Signal Reaction Time Task: no minimum and maximum values as values are reaction times; higher scores indicate worse performance compared to Baseline"|Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)||||reaction time (ms)||Standard Deviation|Mean
2535183|NCT03216512|Primary|Change in CANTAB ADHD Battery - Spatial Working Memory Task|"Compare change from Baseline scores on the Cambridge Automated Neuropsychological Test Battery (CANTAB) ADHD battery with noise cancelling headphones and sham-controls. Results are reported as change from Baseline for each of 4 components of the ADHD battery.~Spatial Working Memory Task: no minimum and maximum values as values are number of errors; higher (positive) scores indicate more errors compared to Baseline"|Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)||||errors||Standard Deviation|Mean
2535184|NCT03216512|Secondary|Change in Academic Productivity Measures -Reading Comprehension|Compares change from Baseline in Test of Silent Reading and Comprehension (TOSREC) Index score across groups; higher scores indicate better performance compared to Baseline; This scale measures an individual's ability to answer questions about an age/grade referenced reading passage in a set amount of time; higher scores indicate better performance compared to Baseline; Index scores are norm-referenced and can be interpreted similar to standard scores with a mean of 100 and a standard deviation of 15. Scores reported here are changes for an individual and can theoretically range from -50 to +50. A higher score indicates better performance in that condition compared to Baseline - ie., better reading comprehension ability|Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)||||Index or Standard Score||Standard Deviation|Mean
2535185|NCT03216512|Secondary|Subjective Reports of Experience|"Compare the self-reports of noise cancelling headphones versus sham controls - How much did the headphones help you concentrate; self-reported ratings scale with 1 being not at all and 10 being extremely; higher scores indicate that participants reported better concentration during the session for each condition"|Experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)||||score on a scale||Standard Deviation|Mean
2535186|NCT03216512|Secondary|Change in Academic Productivity Measures -Math|Compare change from Baseline scores on academic productivity measures (math) - Math Fluency and Calculation Tests (MFACTS) Calculation age standard score; This scale measures an individual's ability to complete age/grade referenced math problems in a set amount of time; higher scores indicate better performance compared to Baseline; standard scores are norm-referenced and have a mean of 100 and a standard deviation of 15. Scores reported here are changes for an individual and can theoretically range from -50 to +50. A higher score indicates better performance in that condition compared to Baseline - ie., better mathematical calculation ability|Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)||||score on a scale||Standard Deviation|Mean
2535258|NCT03214224|Secondary|(Part 1) Patient and Caregiver Reported Outcomes|"Survey responses from the patient/caregiver pair. Likert-type scales are used to generate subscores pertaining to: General Acceptability, Forced Vital Capacity Acceptability, and Maximal Inspiratory Pressure Acceptability.~Subscales (evaluated separately):~General Acceptability [0-5 (worst-best)] Forced Vital Capacity Acceptability [0-5 (worst-best) Maximal Inspiratory Pressure Acceptability [0-5 (worst-best)]"|10 minute survey administered following completion of standard and remote PFT of Part 1|One subject did not complete the survey|||units on a scale||Standard Deviation|Mean
2535187|NCT03216512|Primary|Change in CANTAB ADHD Battery - Motor Control Task|"Compare change from Baseline scores on the Cambridge Automated Neuropsychological Test Battery (CANTAB) ADHD battery with noise cancelling headphones and sham-controls. Results are reported as change from Baseline for each of 4 components of the ADHD battery.~Motor Control Task: no minimum and maximum values as values are reaction times; positive scores indicate slower reaction times compared to baseline; lower scores indicate faster reaction times compared to Baseline"|Baseline, experimental session 1 (3-7 days after baseline), experimental session 2 (3-7 days after experimental session 1)||||reaction time (ms)||Standard Deviation|Mean
2535188|NCT03216265|Secondary|Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Day 29 of Positive Control Treated Site vs. Untreated Site on the Forearm.|TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value has been established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 seconds were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function.|At Baseline and Day 29|Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Number of participants analyzed for this outcome measure were part of the ITT population, evaluated on Day 29.|||g/m^2/hour||Standard Deviation|Mean
2535189|NCT03216265|Secondary|Standardised AUC Calculated Using Change From Day 29 in Corneometry Over Regression Period (Days 30, 31, 32, 33 and 34) on the Forearm and Face|Standardised AUCday29-34 was calculated for each participant for change from day 29 in corneometry on forearms and face over the regression period using the trapezoidal rule and dividing by the number of days in the period. Corneometry was used to measure the moisture content of stratum corneum using corneometer. The measuring principle is based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content. The Corneometer measurements were taken 5 times in total and then an average reading was calculated for each site and time point. An increase in corneometry values indicates an increase in the hydration status of the skin and vice versa.|Up to Day 34|Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies participants with available data for each specified category.|||Corneometry units||Standard Deviation|Mean
2535190|NCT03216265|Secondary|Standardised Area Under Curve (AUCday29-34) Calculated Using Change From Baseline in Corneometry Over Regression Period (Days 30, 31, 32, 33 and 34) on the Forearm and Face|Standardised AUCday29-34 was calculated for each participant for change from baseline in corneometry on forearms and face over the regression period using the trapezoidal rule and dividing by the number of days in the period. Corneometry was used to measure moisture content of stratum corneum using corneometer. The measuring principle is based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content. The Corneometer measurements was taken 5 times in total and then an average reading was calculated for each site and time point. An increase in corneometry values indicates an increase in the hydration status of the skin and vice versa.|Up to Day 34|Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies participants with available data for each specified category.|||Corneometry units||Standard Deviation|Mean
2535191|NCT03216265|Secondary|Change From Day 29 in Corneometry Measurements on Days 30, 31, 32, 33 and 34 in Test Product Treated Site vs. Untreated Site on the Forearm and Face|Corneometry was used to measure the moisture content of stratum corneum using corneometer. The measuring principle is based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content. The Corneometer measurements were taken 5 times in total and then an average reading was calculated for each site and time point. An increase in corneometry values indicates an increase in the hydration status of the skin and vice versa.|At Day 29, 30, 31, 32, 33, and 34|Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points.|||Corneometry units||Standard Deviation|Mean
2535192|NCT03216265|Secondary|Change From Baseline in Corneometry Measurements on Days 30, 31, 32, 33 and 34 in Test Product Treated Site vs. Untreated Site on the Forearm and Face|Corneometry was used to measure the moisture content of stratum corneum using corneometer. The measuring principle is based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content. The Corneometer measurements were taken 5 times in total and then an average reading was calculated for each site and time point. An increase in corneometry values indicates an increase in the hydration status of the skin and vice versa.|At Baseline, Day 30, 31, 32, 33, and 34|Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points.|||Corneometry units||Standard Deviation|Mean
2535224|NCT03214588|Secondary|Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories|The participant assessed the severity of their upper extremity function using the PGI-S 5-point scale where: 0=Not impaired, 1=Mildly impaired, 2=Moderately impaired, 3=Severely impaired and 4=Very severely impaired. The number of participants by PGI-S score category is reported relative to their PGI-S score at Baseline. Only those score categories reported for at least one participant at the given time-point are presented.|Baseline and Weeks 2, 7, and 12|FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||Participants|||Count of Participants
2535193|NCT03216265|Secondary|Change From Day 29 in Standardised Area Under Curve (AUCday 29-34) of Transepidermal Water Loss (TEWL) Over Regression Period (Days 30, 31, 32, 33 and 34) of Forearm and Face, Test Product Treated vs. Untreated Sites|Standardised AUCday29-34 was calculated for each participant for change from Day 29 in TEWL on forearms and face over the regression period (Day31, 32, 33 and 34) using the trapezoidal rule and dividing by the number of days in the period. TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value was established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function.|Up to Day 34|Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies participants with available data for each specified category.|||g/m^2/hour||Standard Deviation|Mean
2535194|NCT03216265|Secondary|Change From Baseline in Standardised Area Under Curve (AUCday 29-34) of Transepidermal Water Loss (TEWL) Over Regression Period (Days 30, 31, 32, 33 and 34) of Forearm and Face, Test Product Treated vs. Untreated Sites|Standardised AUCday29-34 was calculated for each participant for change from baseline in TEWL on forearms and face over the regression period (Day31, 32, 33 and 34) using the trapezoidal rule and dividing by the number of days in the period. TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value was established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function.|Up to Day 34|Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies participants with available data for each specified category.|||g/m^2/hour||Standard Deviation|Mean
2535195|NCT03216265|Secondary|Change From Day 29 in Transepidermal Water Loss (TEWL) Measurements on Days 30, 31, 32, 33 and 34 in Test Product Treated vs. Untreated Sites on the Forearm and Face|TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value was established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function.|At Day 30, 31, 32, 33, and 34|Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points.|||g/m^2/hour||Standard Deviation|Mean
2535196|NCT03216265|Secondary|Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Days 30, 31, 32, 33 and 34 in Test Product Treated vs. Untreated Sites on the Forearm and Face|TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value was established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function.|At Baseline, Day 30, 31, 32, 33 and 34|Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points.|||g/m^2/hour||Standard Deviation|Mean
2535197|NCT03216265|Secondary|Protein Analysis of D-Squame Discs (Total of 9 Adhesive Discs) From Skin of Both Test Product Treated and Untreated Sites on the Face on Day 29|The protein content of each D-Squame disc was analysed using a SquameScan. SquameScan is the instrument used to indirectly measure the protein content extracted from the skin by D-squame tape strips. The determination was performed by measuring the optical absorption of the strip at about 850 nm (infrared light). The value displayed in % was proportionally related to the protein content. The protein content was analysed for each of the discs obtained the D-Squame stripping on the face and reported to 2 decimal places.|On Day 29|Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Number of participants analyzed for this outcome measure were part of the ITT population, evaluated on Day 29.|||percent of absorption||Standard Deviation|Mean
2535198|NCT03216265|Secondary|Protein Analysis (SquameScan) of D-Squame Discs (Total of 12 Adhesive Discs) From Skin of Both Test Product Treated and Untreated Sites on the Forearm on Day 29|The protein content of each D-Squame disc was analysed using a SquameScan. SquameScan is the instrument used to indirectly measure the protein content extracted from the skin by D-squame tape strips. The determination was performed by measuring the optical absorption of the strip at about 850 nanometres (nm) (infrared light). The value displayed in % was proportionally related to the protein content. The protein content was analysed for each of the discs obtained the D-Squame stripping on the forearms and reported to 2 decimal places.|On Day 29|Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Number of participants analyzed for this outcome measure were part of the ITT population, evaluated on Day 29.|||Percent||Standard Deviation|Mean
2535225|NCT03214588|Secondary|Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline|The clinician used the CGI-S scale to assess the severity of the participant's upper extremity function on a 5-point scale where: 0=Not impaired, 1=Mildly impaired, 2=Moderately impaired, 3=Severely impaired and 4=Very severely impaired. The number of participants by CGI-S score category is reported relative to their CGI-S score at Baseline. Only those score categories reported for at least one participant at the given time-point are presented.|Baseline and Week 2, 7, and 12|FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||Participants|||Count of Participants
2535199|NCT03216265|Secondary|Change From Pre-challenge in Transepidermal Water Loss (TEWL) Measurements of D-Squame Discs Following 3, 6 and 9 Adhesive Discs Removal From Skin of Both Test Product Treated and Untreated Sites on the Face on Day 29|A series of D-Squame discs were gently smoothed over the designated D-Squame Areas by applying a uniform pressure for 5 secs with a stamp to ensure consistent adhesion to the skin. Each disc was pulled off the skin with one fluent and decisive movement. There were maximum of 9 D-Squame discs (in groups of 3) removed from the face repeatedly. TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value has been established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. TEWL was measured pre-challenge and after 3, 6 and 9 discs have been removed from the face. An increase in TEWL values shows damage to the skin barrier function.|On Day 29 (including Pre-challenge)|Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies participants with available data for each specified category.|||g/m^2/hour||Standard Deviation|Mean
2535200|NCT03216265|Secondary|Change From Pre-challenge in Transepidermal Water Loss (TEWL) Measurements of D-Squame Discs Following 4, 8 and 12 Adhesive Discs Removal From Skin of Both Test Product Treated and Untreated Sites on the Forearm on Day 29|A series of D-Squame discs were gently smoothed over the designated D-Squame Areas by applying a uniform pressure for 5 secs with a stamp to ensure consistent adhesion to the skin. Each disc was pulled off the skin with one fluent and decisive movement. There were maximum of 12 D-Squame discs (in groups of 4) removed from each forearm repeatedly. TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value has been established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. TEWL was measured pre-challenge and after 4, 8 and 12 discs have been removed from the forearms. An increase in TEWL values shows damage to the skin barrier function.|On Day 29 (including Pre-challenge)|Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies participants with available data for each specified category.|||g/m^2/hour||Standard Deviation|Mean
2535201|NCT03216265|Secondary|Standardised Area Under Curve (AUC1-29) of Change From Baseline in Transepidermal Water Loss (TEWL) Over Treatment Period|Standardised AUC1-29 was calculated for each participant for change from baseline in TEWL on forearms and face over the treatment period; i.e. up to Day 29 using the trapezoidal rule and dividing by the number of days in the period. TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value has been established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function.|Up to Day 29|Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies participants with available data for each specified category.|||g/m^2/hour||Standard Deviation|Mean
2535202|NCT03216265|Secondary|Standardised Area Under Curve (AUC1-29) of Change From Baseline in Corneometry Over Treatment Period|Standardised AUC1-29 was calculated for each participant for change from baseline in corneometry on forearms and face over the treatment period; i.e. up to Day 29 using the trapezoidal rule and dividing by the number of days in the period. Corneometry was used to measure moisture content of stratum corneum using corneometer. The measuring principle is based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content. The Corneometer measurements was taken 5 times in total and then an average reading was calculated for each site and time point. An increase in corneometry values indicates an increase in the hydration status of the skin and vice versa.|Up to Day 29|Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies participants with available data for each specified category.|||Corneometry units||Standard Deviation|Mean
2535203|NCT03216265|Secondary|Change From Baseline in Transepidermal Water Loss (TEWL) on the Forearm and Face, Test Product Treated vs. Untreated Sites at Day 2 and 15|TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value has been established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function.|At Baseline, Day 2, and 15|Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points.|||g/m^2/hour||Standard Deviation|Mean
2535214|NCT03214952|Secondary|Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved|"Percentage of participants who treated for duodenal ulcer and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as Improved."|Baseline and at the end of the survey (up to 6 weeks)|Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for duodenal ulcer within Efficacy assessment population and evaluable for subjective symptoms were analyzed for this outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
2535204|NCT03216265|Secondary|Change From Baseline in Corneometry on the Forearm and Face, Test Product Treated vs. Untreated Sites|Corneometry was used to measure moisture content of stratum corneum using corneometer. The measuring principle is based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content. The Corneometer measurements was taken 5 times in total and then an average reading was calculated for each site and time point. An increase in corneometry values indicates an increase in the hydration status of the skin and vice versa.|At Baseline, Day 1 (30 minutes and 6 hours post study product application), Day 2, 15, and 29|Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points.|||Corneometry Units||Standard Deviation|Mean
2535205|NCT03216265|Secondary|Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Day 29, Test Product Treated vs. Untreated Sites on the Face|TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 secs, to ensure that a stable value has been established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function.|At Baseline and Day 29|Analysis population was ITT (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Number of participants analyzed for this outcome measure were part of the ITT population, evaluated on Day 29.|||g/m^2/hour||Standard Deviation|Mean
2535206|NCT03216265|Primary|Change From Baseline in Transepidermal Water Loss (TEWL) Measurements on Day 29, Test Product Treated Versus (vs.) Untreated Sites on the Forearm|TEWL measuring principle is based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 seconds (sec), to ensure that a stable value has been established. The first part of the measurement belongs to the equilibration phase. The values of the last 10 secs were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function.|At Baseline and Day 29|Analysis population was Intent To Treat (ITT) (N=65) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Number of participants analyzed for this outcome measure were part of the ITT population, evaluated on Day 29.|||gram (g)/meter(m)^2/hour||Standard Deviation|Mean
2535207|NCT03216200|Secondary|Clear Nail Growth|Number of patients with photographic evidence of increased clear nail growth|5 months after the first treatment||||Participants|||Count of Participants
2535208|NCT03216200|Primary|Mycological Cure|number of participants with mycological cure defined as two consecutive negative cultures per FDA guideline|2 cultures taken a week apart within 2 weeks after the first treatment||||Participants|||Count of Participants
2535209|NCT03215758|Secondary|Change From Baseline in Asthma Quality of Life (AQLQ+12) Score|"AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated better quality of life. Overall AQLQ+12 score is the mean of all 32 responses."|Week 12|Full analysis set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization.|||units on a scale||Standard Error|Least Squares Mean
2535210|NCT03215758|Secondary|Change From Baseline in Daily Use of SABA|Daily use of SABA (the number of rescue medication puffs taken in the previous 12 hours) was recorded using a patient electronic diary (referred to as eDiary or eDiary/ePEF). Patients were instructed to routinely complete the patient diary twice daily - at the same time each morning and each evening, approximately 12 hours apart.|12 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization.|||Number of puffs||Standard Error|Least Squares Mean
2535211|NCT03215758|Secondary|Change From Baseline in Daytime Asthma Symptom Score|Daytime asthma symptoms are evaluated through four questions and each of them will be rated on a scale of 0 to 6. Higher scores indicate more severe asthma-related symptoms. A mean score will be calculated for the responses to 4 questions.|12 weeks|Full analysis set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization.|||Score||Standard Error|Least Squares Mean
2535212|NCT03215758|Primary|Change From Baseline in Pre-dose FEV1 at Week 12|Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.|Week 12|Full analysis set (FAS): all randomized patients who received at least one dose of study medication. Patients in the FAS were analyzed according to the treatment they were assigned to at randomization.|||Liters||Standard Error|Least Squares Mean
2535213|NCT03214952|Secondary|Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved|"Percentage of participants who treated for reflux esophagitis and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as Improved."|Baseline and at the end of the survey (up to 8 weeks)|Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for reflux esophagitis within Efficacy assessment population and evaluable for subjective symptoms were analyzed for this outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
2535215|NCT03214952|Secondary|Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved|"Percentage of participants who treated for gastric ulcer and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as Improved."|Baseline and at the end of the survey (up to 8 weeks)|Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for gastric ulcer within Efficacy assessment population and evaluable for subjective symptoms were analyzed for this outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
2535216|NCT03214952|Secondary|Endoscopic Cure Rate in Participants With Reflux Esophagitis|Endoscopic cure rate was defined as a percentage of participants who treated for reflux esophagitis and met the criteria of Grade N or M in the modified Los Angeles (LA) classification at the end of survey. Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity.|Up to 8 weeks|Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for reflux esophagitis within Efficacy assessment population and evaluable for endoscopic cure rate were analyzed for this outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
2535217|NCT03214952|Secondary|Endoscopic Cure Rate in Participants With Duodenal Ulcer|Endoscopic cure rate was defined as a percentage of participants treated for duodenal ulcer who classified as Scarring stage at the end of survey per Sakita-Miwa Classification. Endoscopic findings of ulcer were classified per Sakita-Miwa Classification as follows; Active stage: A1 and A2, Healing stage: H1 and H2, Scarring stage: S1 and S2.|Up to 6 weeks|Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for duodenal ulcer within Efficacy assessment population and evaluable for endoscopic cure rate were analyzed for this outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
2535218|NCT03214952|Secondary|Endoscopic Cure Rate in Participants With Gastric Ulcer|Endoscopic cure rate was defined as a percentage of participants treated for gastric ulcer who classified as Scarring stage at the end of survey per Sakita-Miwa Classification. Endoscopic findings of ulcer were classified per Sakita-Miwa Classification as follows; Active stage: A1 and A2, Healing stage: H1 and H2, Scarring stage: S1 and S2.|Up to 8 weeks|Efficacy assessment population, participants who completed the survey and evaluable for efficacy; Participants who treated for gastric ulcer within Efficacy assessment population and evaluable for endoscopic cure rate were analyzed for this outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
2535219|NCT03214952|Primary|Percentage of Participants With Reflux Esophagitis Who Had One or More Adverse Drug Reactions|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to the administered drug.|Up to 8 weeks|Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. Participants who treated for reflux esophagitis within the Safety Analysis Set were analyzed for this outcome measure.|||Percentage of Participants|||Number
2535220|NCT03214952|Primary|Percentage of Participants With Duodenal Ulcer Who Had One or More Adverse Drug Reactions|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to the administered drug.|Up to 6 weeks|Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. Participants who treated for duodenal ulcer within the Safety Analysis Set were analyzed for this outcome measure.|||Percentage of Participants|||Number
2535221|NCT03214952|Primary|Percentage of Participants With Gastric Ulcer Who Had One or More Adverse Drug Reactions|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to the administered drug.|Up to 8 weeks|Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. Participants who treated for gastric ulcer within the Safety Analysis Set were analyzed for this outcome measure.|||Percentage of Participants|||Number
2535222|NCT03214588|Secondary|Number of Participants With at Least a 15 Percent (%) or at Least a 20% Reduction in 9-HPT Completion Time From Baseline|The 9-HPT-1 is a measure of timed upper extremity (arm and hand) function and manual dexterity. The participant picks up pegs 1 at a time (9 in total), using 1 hand only, and places them into holes on the board as quickly as possible, in any order until all holes are filled. Then, without pausing, the participant removes the pegs 1 at a time and returns them as quickly as possible. Each participant performs this task twice with each hand separately. Results on both tests are then averaged for an overall task completion time.|Baseline up to Week 12|FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||Participants|||Count of Participants
2535223|NCT03214588|Secondary|Change From Baseline in the ADL Component Score for Upper Limb Function Items of the FARS|The ADL component of the FARS includes 9 subscales: speech, swallowing, cutting food and handling utensils, dressing, personal hygiene, falling, walking, quality of sitting position, and bladder function. Items 3 to 5 are directly related to upper limb function. Each of these subscales is rated on a 5-point scale where 0=normal to 4=severe disability/inability to carry out activity independently for a total possible score of 0 to 12, with higher scores representing greater disability/dependency. A negative change from Baseline indicates improvement. Change from Baseline in Friedreich ataxia rating scale activities of daily living (FARS ADL) upper limb function items was analyzed using MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Baseline and Weeks 2, 7 and 12|FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
2535226|NCT03214588|Secondary|Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline|The participant assessed the severity of their disease overall using the PGI-S 5-point scale where: 0=No symptoms, 1=Mild, 2=Moderate, 3=Severe and 4=Very severe. The number of participants by PGI-S score category is reported relative to their PGI-S score at Baseline. Only those score categories reported for at least one participant at the given time-point are presented.|Baseline and Weeks 2, 7, and 12|FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||Participants|||Count of Participants
2535227|NCT03214588|Secondary|Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline|The clinician used the CGI-S scale to assess the severity of the participant's disease overall on a 5-point scale where: 0=No symptoms, 1=Mild, 2=Moderate, 3=Severe and 4=Very severe. The number of participants by CGI-S score category is reported relative to their CGI-S score at Baseline. Only those score categories reported for at least one participant at the given time-point are presented.|Baseline and Weeks 2, 7, and 12|FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||Participants|||Count of Participants
2535228|NCT03214588|Secondary|Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories|The participant used the PGI-I scale to assess their improvement (or worsening) in upper extremity function relative to Baseline on a 7-point scale where: 1=Much improved, 2=Moderately improved, 3=A little improved, 4=No change, 5=A little worse, 6=Moderately worse and 7=Much worse. Only those score categories reported for at least one participant at the given time-point are presented.|Weeks 2, 7, and 12|FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||Participants|||Count of Participants
2535229|NCT03214588|Secondary|Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories|The clinician used the CGI-I scale to assess the participant's improvement (or worsening) in upper extremity function relative to Baseline on a 7-point scale where: 1=Much improved, 2=Moderately improved, 3=A little improved, 4=No change, 5=A little worse, 6=Moderately worse and 7=Much worse. Only those score categories reported for at least one participant at the given time-point are presented.|Weeks 2, 7, and 12|FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||Participants|||Count of Participants
2535230|NCT03214588|Secondary|Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories|The participant used the PGI-I scale to assess their improvement (or worsening) overall relative to Baseline on a 7-point scale where: 1=Much improved, 2=Moderately improved, 3=A little improved, 4=No change, 5=A little worse, 6=Moderately worse and 7=Much worse. Only those score categories reported for at least one participant at the given time-point are presented.|Weeks 2, 7 and 12|FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||Participants|||Count of Participants
2535231|NCT03214588|Secondary|Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories|The clinician used the CGI-I scale to assess the participant's improvement (or worsening) overall relative to Baseline on a 7-point scale where: 1=Much improved, 2=Moderately improved, 3=A little improved, 4=No change, 5=A little worse, 6=Moderately worse and 7=Much worse. Only those score categories reported for at least one participant at the given time-point are presented.|Weeks 2, 7, and 12|FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||Participants|||Count of Participants
2535232|NCT03214588|Secondary|Change From Baseline in Low-Contrast Letter Acuity (LCLA) Test Score|The LCLA test assessed visual function in both eyes using the Low-Contrast Sloan Letter Charts at different contrast levels. The score ranged from 0 to 70, where 0=worst visual functioning and 70=best visual functioning. A positive change from Baseline indicates improvement. The change from Baseline in LCLA was analyzed using MMRM ANCOVA with Baseline LCLA as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline LCLA-by-visit interactions.|Baseline and Weeks 2, 7, and, 12|FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
2535233|NCT03214588|Secondary|Change From Baseline in the 9-HPT and T25FW Composite Score|9-HPT and T25FW were evaluated together as a performance-based composite measure. The inverse transform of each score was computed. The inverse scores from each test were tabulated and converted to test-specific Z scores by subtracting the cohort mean from the raw score, and then dividing by the cohort standard deviation (SD) to create a Z score for the test. The composite Z scores were created by subtracting Z-score for T25FW from the Z-score for 9-HPT-1. A larger Z-score represents a better outcome. A positive change from Baseline indicates improvement. Change from Baseline in composite score was analyzed using MMRM ANCOVA with Baseline composite score as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline composite score-by-visit interactions.|Baseline and Weeks 2, 7, and 12|FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||z-score||Standard Error|Least Squares Mean
2535259|NCT03214224|Primary|(Part 2) Longitudinal Remote PFT - MIP|The results of remote MIP testing during in between clinical visits.|15 minute assessment done weekly for one year||2020-09-30|09/2020||||
2535260|NCT03214224|Primary|(Part 2) Longitudinal Remote PFT - FVC|The results of remote FVC testing during in between clinical visits.|15 minute assessment done weekly for one year||2020-09-30|09/2020||||
2535261|NCT03214224|Primary|(Part 2) Longitudinal Standard PFT - MIP|The result of standard MIP testing during clinical visits|10 minute assessment done approximately every 3 months for one year||2020-09-30|09/2020||||
2535234|NCT03214588|Secondary|Change From Baseline in the Timed 25-Foot Walk (T25FW)|The participant was instructed to walk 25 feet as quickly as possible, but safely. The time was calculated from the initiation of the instruction to start and ends when the participant has reached the 25-foot mark. The task was immediately administered again by having the participant walk back the same distance. The two trials were averaged. A negative change from Baseline indicates improvement. Change from Baseline in T25FW was analyzed using MMRM ANCOVA with Baseline T25FW as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline T25FW-by-visit interactions.|Baseline and Weeks 2, 7 and 12|FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||seconds||Standard Error|Least Squares Mean
2535235|NCT03214588|Secondary|Change From Baseline in the mFARS-neuro Individual Item Scores|mFARS-neuro examination is a clinician-rated measure based on neural substrates affected in Friedreich ataxia individual items:Cough,Speech,Right(R)Finger to Finger Test,Left(L)Finger to Finger Test,R-Nose to Finger Test,L-Nose to Finger Test,R-Dysmetria Test,L-Dysmetria Test,Rapid Alternating Movement(RAM)of R-Hands,RAM of L-Hands,R-Finger Taps(FT),L-FT,R-Heel Along Shin Slide,L-Heel Along Shin Slide,R-Heel Along Shin Tap,L-Heel Along Shin Tap,Siting Posture,Stance Feet Apart(SFA)-3 Trial Average(TTA),SFA(Eyes Closed)-TTA,Stance Feet Together(SFT)-TTA,SFT(Eyes Closed)-TTA,Tandem Stance-TTA,Stance on Dominant Foot-TTA,Tandem Walk and Gait.Items were scored on scale of 0 to 2,3,4 or 5,with higher scores indicating greater disability.Negative change from Baseline(BL)indicates improvement.Change from BL in mFARS-neuro was analyzed using MMRM ANCOVA with BL as covariate;pooled site,visit,treatment,ambulation status as fixed factors;treatment-by-visit,BL mFARS-neuro-by visit interactions.|Baseline and Weeks 2, 7, and 12|FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
2535236|NCT03214588|Secondary|Change From Baseline in the mFARS-neuro Subscales Scores|The mFARS-neuro neurological examination is a clinician-rated measure based on neural substrates affected in Friedreich ataxia including: bulbar on a scale of 0-11, upper limb coordination on a scale of 0-36, lower limb coordination on a scale of 0-16, and upright stability/gait functions on a scale of 0-36, with the higher scores representing greater disability. A negative change from Baseline indicates improvement. Change from Baseline in mFARS-neuro was analyzed using MMRM ANCOVA with Baseline mFARS-neuro as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline mFARS-neuro-by visit interactions.|Baseline and Weeks 2, 7, and 12|FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||unit on a scale||Standard Error|Least Squares Mean
2535237|NCT03214588|Secondary|Change From Baseline in the Modified Friedreich Ataxia Rating Scale Neurological Examination (mFARS-neuro) Total Score|The mFARS-neuro neurological examination is a clinician-rated measure based on neural substrates affected in Friedreich ataxia including: bulbar on a scale of 0-11, upper limb coordination on a scale of 0-36, lower limb coordination on a scale of 0-16, and upright stability/gait functions on a scale of 0-36 for a total possible score of 0 to 99 with higher scores representing greater disability. A negative change from Baseline indicates improvement. Change from Baseline in mFARS-neuro was analyzed using MMRM ANCOVA with Baseline mFARS-neuro as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline mFARS-neuro-by-visit interactions.|Baseline and Weeks 2, 7 and 12|FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
2535238|NCT03214588|Secondary|Change From Baseline in the ADL Component Individual Item Scores|The ADL component of the FARS includes 9 subscales: speech, swallowing, cutting food and handling utensils, dressing, personal hygiene, falling, walking, quality of sitting position, and bladder function. Each of these subscales is rated on a 5-point scale where 0=normal to 4=severe disability/inability to carry out activity independently. A negative change from Baseline indicates improvement. Statistical analyses were available for the following subscales: cutting food-handling utensils, dressing and personal hygiene.|Baseline and Weeks 2, 7 and 12|FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
2535239|NCT03214588|Secondary|Change From Baseline in the Inverse Time to Complete the 9-HPT-1|The 9-HPT-1 is a measure of timed upper extremity (arm and hand) function and manual dexterity. The participant picks up pegs 1 at a time (9 in total), using 1 hand only, and places them into holes on the board as quickly as possible, in any order until all holes are filled. Then, without pausing, the participant removes the pegs 1 at a time and returns them as quickly as possible. Each participant performs this task twice with each hand separately. Results on both tests are then averaged for an overall task completion time, and the inverse transform is performed. A positive change from Baseline indicates improvement. Change from Baseline in 9-HPT-1 was analyzed using MMRM ANCOVA with Baseline 9-HPT-1 as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline 9-HPT-1-by-visit interactions.|Baseline and Weeks 2 and 7|FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||1/seconds||Standard Error|Least Squares Mean
2535248|NCT03214380|Secondary|Change From Baseline in Insulin Dose at Week 26|Change from baseline in insulin dose was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data prior to permanent discontinuation of study drug.|Baseline, Week 26|All randomized participants with baseline and at least one post-baseline basal insulin dose data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.|||Units (U)||Standard Error|Least Squares Mean
2535240|NCT03214588|Secondary|Change From Baseline in the Activities of Daily Living (ADL) Component Score of the Friedreich Ataxia Rating Scale (FARS)|The ADL component of the FARS includes 9 subscales: speech, swallowing, cutting food and handling utensils, dressing, personal hygiene, falling, walking, quality of sitting position, and bladder function. Each of these subscales is rated on a 5-point scale where 0=normal to 4=severe disability/inability to carry out activity independently for a total possible score of 0 to 36, with higher scores representing greater disability/dependency. A negative change from Baseline indicates improvement. Change from Baseline in FARS ADL upper limb function items were analyzed using MMRM ANCOVA with Baseline FARS ADL as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline FARS ADL-by-visit interactions.|Baseline and Weeks 2, 7 and 12|FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
2535241|NCT03214588|Primary|Change From Baseline in the Inverse Time to Complete the 9-Hole Peg Test (9-HPT-1)|The 9-HPT-1 is a measure of timed upper extremity (arm and hand) function and manual dexterity. The participant picks up pegs 1 at a time (9 in total), using 1 hand only, and places them into holes on the board as quickly as possible, in any order until all holes are filled. Then, without pausing, the participant removes the pegs 1 at a time and returns them as quickly as possible. Each participant performs this task twice with each hand separately. Results on both tests are then averaged for an overall task completion time and the inverse transform is performed. A positive change from Baseline indicates improvement. Change from Baseline in 9-HPT-1 was analyzed using mixed model for repeated measures (MMRM) analysis of covariance (ANCOVA) with Baseline 9-HPT-1 as a covariate; pooled site, visit, treatment, and ambulation status (randomization factor) as fixed factors; and treatment-by-visit and Baseline 9-HPT-1-by-visit interactions.|Baseline and Week 12|Full analysis set (FAS) included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point.|||1/seconds||Standard Error|Least Squares Mean
2535242|NCT03214406|Primary|Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque Efficacy|change in score as measured by Plaque Index (0=no visible plaque, 1=separate flecks of plaque at the cervical margin of the tooth, 2=a thin, continuous band of plaque (up to 1mm wide) at the cervical margin, 3= a band of plaque wider than 1 mm but covering less than one-third of the crown, 4=plaque covering at least one-third but less than two-thirds of the crown, 5= plaque covering two-thirds or more of the crown. The scale ranges from 0-5.|16 weeks||||units on a scale||Standard Deviation|Mean
2535243|NCT03214406|Primary|Within-Treatment Whole-Mouth Differences (vs Baseline) Gingival Bleeding Efficacy|change in score as measured by Gingival Bleeding Index (0=absence of bleeding after 30 seconds, 1= bleeding observed after 30 seconds, 2= bleeding occurs instantly). The scale ranges from 0-2.|16 weeks||||units on a scale||Standard Deviation|Mean
2535244|NCT03214406|Primary|Within-Treatment Whole-Mouth Differences (vs Baseline) - Gingival Efficacy|change in score as measured by Gingival Index (0=absence of inflammation, 1=mild inflammation: slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit, 2=mild inflammation: slight change in color, little change in texture to entire marginal or papillary gingival unit, 3=moderate inflammation: glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit, 4=severe inflammation: marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The scale ranges from 0-4.|16 weeks||||units on a scale||Standard Deviation|Mean
2535245|NCT03214380|Secondary|Number of Participants With HbA1c <7%|Number of participants with HbA1c <7% at Week 26.|Week 26|All participants with baseline and one post-baseline observation while on study drug. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.|||Participants|||Count of Participants
2535246|NCT03214380|Secondary|Change From Baseline in ITSQ Lifestyle Flexibility Domain Score at Week 26|"ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction.~Change from baseline in ITSQ lifestyle flexibility domain score was calculated using the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug."|Baseline, Week 26|All randomized participants with baseline and post-baseline data. Missing endpoints were imputed by applying the LOCF method to the post-baseline data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.|||units on a scale||Standard Error|Least Squares Mean
2535247|NCT03214380|Secondary|Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score at Week 26|"ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction.~Change from baseline in ITSQ regimen inconvenience domain score was calculated using the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum), and treatment as fixed effects and baseline as covariate. The analysis included data prior to permanent discontinuation of study drug."|Baseline, Week 26|All randomized participants with baseline and post-baseline data. Missing endpoints were imputed by applying the Last Observation Carried Forward (LOCF) method to post-baseline data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.|||units on a scale||Standard Error|Least Squares Mean
2535262|NCT03214224|Primary|(Part 2) Longitudinal Standard PFT - FVC|The result of standard FVC testing during clinical visits|10 minute assessment done every three months for a year||2020-09-30|09/2020||||
2535249|NCT03214380|Secondary|Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values at Week 26|Change from baseline in 10-point SMBG values was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement prior to permanent discontinuation of study drug.|Baseline, Week 26|All randomized participants with baseline and at least one post-baseline SMBG data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.|||mg/dL||Standard Error|Least Squares Mean
2535250|NCT03214380|Secondary|Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26|Change from baseline in 1,5-AG was analyzed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, HbA1c stratum and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The analysis included data collected prior to permanent discontinuation of study drug.|Baseline, Week 26|All randomized participants with baseline and at least one post-baseline 1,5-AG data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.|||milligram per liter (mg/L)||Standard Error|Least Squares Mean
2535251|NCT03214380|Secondary|Rate of Documented Symptomatic Hypoglycemia|Documented symptomatic hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of <54 mg/dL [3.0 millimole per liter (mmol/L)]. The rate of documented symptomatic hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable.|Baseline through Week 26|All randomized participants with evaluable hypoglycemic data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.|||Events per participant per 30 days/year||Standard Error|Least Squares Mean
2535252|NCT03214380|Secondary|Rate of Severe Hypoglycemia|Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within a treatment group *36525. Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. During these episodes, the participant has an altered mental status and cannot assist in his or her own care, or may be semiconscious or unconscious, or experience com with or without seizures, and may require parenteral therapy.|Baseline through Week 26|All randomized participants with evaluable hypoglycemic data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.|||Events per 100 participant years|||Number
2535253|NCT03214380|Secondary|2-hour PPG Excursion During MMTT Efficacy Estimand|2-hour PPG excursion during MMTT uses the ANCOVA model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.|Week 26|All randomized participants with baseline and at least one post-baseline 2-hour PPG excursion data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.|||mg/dL||Standard Error|Least Squares Mean
2535254|NCT03214380|Secondary|1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) Efficacy Estimand|1-hour PPG excursion during MMTT uses the analysis of covariance (ANCOVA) model with strata (pooled country, type of basal insulin, number of prandial doses at study entry, and HbA1c stratum) and treatment as fixed effects and baseline as a covariate. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.|Week 26|All randomized participants with baseline and at least one post-baseline 1-hour PPG excursion data. As pre-specified in the analysis plan, outcome measures will not be reported for the MEE arms/groups but only for the main global study arms/groups.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2535255|NCT03214380|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26|Change from baseline in HbA1c was performed using mixed model repeated measures (MMRM) including fixed class effects of treatment, strata (pooled country, type of basal insulin, and number of prandial doses at study entry), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. The efficacy estimand included participant data when baseline and at least one post-baseline measurement were available prior to permanent discontinuation of study drug.|Baseline, Week 26|All randomized participants with baseline and at least 1 post-baseline HbA1c data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (MEE) arms/groups but only for the main global study arms/groups.|||percentage of HbA1c||Standard Error|Least Squares Mean
2535256|NCT03214224|Secondary|(Part 2) Survival Data|Study participants will be followed after completion of study procedures and date of death, if available,will be recorded. Survival rates between the experimental and control groups will be compared.|During and one year following primary data collection period.|||||||
2535257|NCT03214224|Secondary|(Part 1) Therapist Reported Outcomes|"Survey responses from the respiratory therapist. Likert-type scales are used to generate subscores pertaining to: General Acceptability, Forced Vital Capacity Acceptability, and Maximal Inspiratory Pressure Acceptability.~Subscales (evaluated separately):~General Acceptability [0-5 (worst-best)] Forced Vital Capacity Acceptability [0-5 (worst-best) Maximal Inspiratory Pressure Acceptability [0-5 (worst-best)]"|10 minute survey administered following completion of standard and remote PFT of Part 1|There were three therapists who produced 35 separate survey responses. Responses from 5 patient interactions were not available.|||units on a scale||Standard Deviation|Mean
2535263|NCT03214224|Primary|(Part 1) Remote PFT - Maximal Inspiratory Pressure|Respiratory therapist will use the telehealth interface to guide the patient and caregiver to self-administer three valid MIP maneuvers. The best MIP value is the outcome.|One administration - 10 minutes|40 patients taking part in validation study|||cm water||Standard Deviation|Mean
2535264|NCT03214224|Primary|(Part 1) Remote PFT - Forced Vital Capacity|Respiratory therapist will use the telehealth interface to guide the patient and caregiver to self-administer three valid FVC maneuvers. The best FVC value is the outcome.|One administration - 10 minutes|40 patients taking part in validation study|||Percent predicted of FVC||Standard Deviation|Mean
2535265|NCT03214224|Primary|(Part 1) Standard PFT - Maximal Inspiratory Pressure|Respiratory therapist will administer three valid maneuvers of maximal inspiratory pressure (MIP). The best MIP value is the outcome.|One administration - 10 minutes|40 patients taking part in validation study|||cm water||Standard Deviation|Mean
2535266|NCT03214224|Primary|(Part 1) Standard PFT - Forced Vital Capacity|Respiratory therapist will administer three valid maneuvers of forced vital capacity (FVC) The best FVC value is the outcome.|One administration - 10 minutes|40 patients taking part in validation study|||Percent Predicted FVC||Standard Deviation|Mean
2535267|NCT03214094|Secondary|Percentage of Participants With Hemorrhagic Lesions on Duodenum After the Start of Administration of Vonoprazan Tablets|Reported data were percentage of participants who had hemorrhagic lesions on duodenum after the start of administration of vonoprazan tablets.|Up to 12 months|Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.|||Percentage of Participants|||Number
2535268|NCT03214094|Secondary|Percentage of Participants With Hemorrhagic Lesions on Stomach After the Start of Administration of Vonoprazan Tablets|Reported data were percentage of participants who had hemorrhagic lesions on stomach after the start of administration of vonoprazan tablets.|Up to 12 months|Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.|||Percentage of Participants|||Number
2535269|NCT03214094|Secondary|Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets|Reported data were percentage of participants who experienced an onset of duodenal ulcers after the start of administration of vonoprazan tablets.|Up to 12 months|Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.|||Percentage of Participants|||Number
2535270|NCT03214094|Secondary|Percentage of Participants With Gastric Ulcers After the Start of Administration of Vonoprazan Tablets|Reported data were percentage of participants who experienced an onset of gastric ulcers after the start of administration of vonoprazan tablets.|Up to 12 months|Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.|||Percentage of Participants|||Number
2535271|NCT03214094|Primary|Percentage of Participants Who Had One or More Adverse Drug Reactions|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.|Up to 12 months|Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.|||Percentage of Participants|||Number
2535272|NCT03214081|Secondary|Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia|Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe anorexia at each time points were reported.|Baseline, Month 6 and at Month 12|Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable at each time point.|||Participants|||Count of Participants
2535273|NCT03214081|Secondary|Number of Participants With Recorded Severity of Subjective Symptoms of Belching|Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe belching at each time points were reported.|Baseline, Month 6 and at Month 12|Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable at each time point.|||Participants|||Count of Participants
2535274|NCT03214081|Secondary|Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting|Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe nausea/vomiting at each time points were reported.|Baseline, Month 6 and at Month 12|Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable at each time point.|||Participants|||Count of Participants
2535275|NCT03214081|Secondary|Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating|Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe abdominal bloating at each time points were reported.|Baseline, Month 6 and at Month 12|Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable at each time point.|||Participants|||Count of Participants
2535303|NCT03212690|Secondary|Renin-angiotensin System Cascade Biomarker: Ang II/ Ang(1-7) Ratio|Blood samples were collected for renin-angiotensin system biomarkers at indicated time points.|Days 1, 2 and 3|Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Ratio||Standard Deviation|Mean
2535276|NCT03214081|Secondary|Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning|Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe epigastric burning at each time points were reported.|Baseline, Month 6 and at Month 12|Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable at each time point.|||Participants|||Count of Participants
2535277|NCT03214081|Secondary|Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain|Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe epigastric pain at each time points were reported.|Baseline, Month 6 and at Month 12|Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable at each time point.|||Participants|||Count of Participants
2535278|NCT03214081|Secondary|Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation|Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe early satiation at each time points were reported.|Baseline, Month 6 and at Month 12|Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable at each time point.|||Participants|||Count of Participants
2535279|NCT03214081|Secondary|Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness|Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe postprandial fullness at each time points were reported.|Baseline, Month 6 and at Month 12|Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable at each time point.|||Participants|||Count of Participants
2535280|NCT03214081|Secondary|Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux|Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe acid reflux at each time points were reported.|Baseline, Month 6 and at Month 12|Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable at each time point.|||Participants|||Count of Participants
2535281|NCT03214081|Secondary|Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn|Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe heartburn at each time points were reported.|Baseline, Month 6 and at Month 12|Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable at each time point.|||Participants|||Count of Participants
2535282|NCT03214081|Secondary|Endoscopic Relapse Rate|Endoscopic relapse rate was defined as a percentage of participants who met the criteria of Grade A to D in the modified Los Angeles (LA) classification. The modified LA classification graded endoscopic findings as follows- Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity; Grade A: non-confluent mucosal breaks <5 mm in length; Grade B: nonconfluent mucosal breaks ≥ 5 mm in length; Grade C: confluent mucosal breaks <75% circumferential; Grade D: confluent mucosal breaks >=75% circumferential.|From the initiation of the maintenance therapy to Month 12 (or discontinuation of the therapy), up to 12 months|Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.|||Percentage of Participants||95% Confidence Interval|Number
2535283|NCT03214081|Primary|Percentage of Participants Who Had One or More Adverse Drug Reactions|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.|Up to 12 months|Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.|||Percentage of Participants|||Number
2535284|NCT03213509|Other Pre-specified|Sex of Babies Who Suffered Perinatal Mortality|This measure refers to the sex of the babies who suffered a perinatal mortality, and whose mother/family member was interviewed about the death via verbal autopsy|Within 7 days postpartum||||Participants|||Count of Participants
2535285|NCT03213509|Primary|Cause of Early Neonatal Death|Cause of Early Neonatal Death|Early post-natal period (up to 7 days post-partum)||||Participants|||Count of Participants
2535286|NCT03213509|Primary|Cause of Stillbirth|Cause of Stillbirth|Early post-natal period (up to 7 days post-partum)||||Participants|||Count of Participants
2535287|NCT03213509|Primary|Cause of Death|Cause of perinatal mortality|Early post-natal period (up to 7 days post-partum)||||Participants|||Count of Participants
2535288|NCT03213366|Other Pre-specified|Trust in the Peer by Participant|"The scale measure the level of trust the Participant had on the Peer's online post.~Trust in the Peer Leader was measured using 4 questions, each scored from 1-7 (1=Strongly Disagree, 7=Strongly Agree). The score for the 4 questions was summed for each participant. The score ranged from 1-28 with higher scores indicating a higher level of trust the participant had in their Peer Leader."|at baseline and 6 weeks|The total number of participants who completed baseline study was 81 for e-prep and 71 for control. The analysis for 6 weeks included only the people who completed the survey at each that time period.|||score on a scale||Standard Deviation|Mean
2535289|NCT03213366|Other Pre-specified|Number of Participants With Self-reported Linkage-to-Care|Self-reported information about health care access (i.e. going to a medical appointment).|at baseline, 6 weeks, and 12 weeks|"Each row has the number of participants who access healthcare at each time point in the yes category, and the number of people who did not access healthcare in the no category. (Baseline vs. 6 weeks vs. 12 weeks)."|||Participants|||Count of Participants
2535290|NCT03213366|Other Pre-specified|Number of Participants With Self-reported HIV Testing|Self-reported HIV testing at baseline, 6 weeks, and 12 weeks.|at baseline, 6 weeks, and 12 weeks|Each row indicates when the participant who responded to the survey at baseline, 6 weeks, and 12 weeks.|||Participants|||Count of Participants
2535291|NCT03213366|Secondary|Self-efficacy About Using PrEP|Self-reported answer to questions about self-efficacy of using PrEP. There were two questions to measure self-efficacy of PrEP using a Likert scale (ranging from 1-5; 1=Not at all, 5=Extremely). The scores from both questions were summed for each participant. The scale range from 1-10 with higher scores indicating higher the levels of PrEP self-efficacy.|at baseline, 6 weeks, and 12 weeks||||score on a scale||Standard Deviation|Mean
2535292|NCT03213366|Secondary|PrEP Barriers|"Any Barriers to PrEP uptake.~To measure barriers to PrEP uptake, 7 items were used. Each item was measured using a likert scale ( from 1-4; 1=Strongly Disagree, 4= Strongly Agree). The scores of each question were summed for each participant (scale scores ranged 1-28, with higher scores indicating higher levels of PrEP Barriers).~The higher the score, the higher the number of PrEP Barriers."|baseline, 6 weeks, 12 weeks||||score on a scale||Standard Deviation|Mean
2535293|NCT03213366|Secondary|Communication About PrEP|"Discussion of PrEP with friends, partners, or family. Communication about PrEP was measured with 2 questions, using a Likert scale ( from 1-5;1=Not at all, 5= Extremely). The scores of the 2 questions were summed for each participant.~The scores range from 1-10, with higher the score indicating higher the level of communication about PrEP (i.e. higher scores indicates participants communicating more about PrEP)."|baseline, 6 weeks, 12 weeks||||score on a scale||Standard Deviation|Mean
2535294|NCT03213366|Secondary|PrEP Stigma|"Any stigma the participant might have about PrEP or those who use PrEP~To measure PrEP Stigma we asked 3 questions, using a Likert scale (from 1-4; 1= Strongly Disagree, 4=Strongly Agree). The scores were summed for each participant. The scores range from 1-12, with higher scores indicating higher levels of PrEP Stigma.~The higher the score, the higher the level of PrEP stigma."|baseline, 6 weeks, 12 weeks||||score on a scale||Standard Deviation|Mean
2535295|NCT03213366|Secondary|PrEP Awareness|"Awareness about PrEP.~PrEP awareness was measured with one question, scored 1 to 5. The mean for each arm was calculated at each time point.~The higher the score, the higher the level of awareness about PrEP."|baseline, 6 weeks, 12 weeks|T|||score on a scale||Standard Deviation|Mean
2535296|NCT03213366|Secondary|Change in PrEP Knowledge|"Self-reported PrEP related knowledge.~Participants were asked two questions about PrEP knowledge. For each question, they got one point if the answer was correct.~Scale range from 0-2. The score were added and the average of the sum was reported.~The higher the score, the higher the knowledge of PrEP."|at baseline, 6 weeks, and 12 weeks||||score on a scale||Standard Deviation|Mean
2535297|NCT03213366|Primary|Number of Participants Using PrEP Over Time|This outcome is the number of participants who self-report using PrEP at baseline, 6 weeks, or 12 weeks. This was measure by a yes/no question asking if the participant currently uses PrEP (dichotomous variable).|at baseline, 6 weeks, and 12 weeks||||Participants|||Count of Participants
2535298|NCT03213366|Primary|Number of Participants Intending to Start Using PrEP Over Time|"This primary outcome is intention to use PrEP in the next month measured at baseline, 6 weeks, and 12 weeks. This was assessed with a yes/no question (dichotomous variable). However, this variable does not include anyone who reported PrEP use at either 6 or 12 weeks.~This outcome will inform sample size calculations for a subsequent fully powered trial."|baseline, 6 weeks, and 12 weeks|Each of the rows indicates the number of participants who indicated intending to use PrEP at each time point (Baseline vs. 6 weeks vs. 12 weeks).|||Participants|||Count of Participants
2535299|NCT03212690|Secondary|Pearson Correlation Coefficient Between RV Size Ratio and Ang II/Ang(1-7)|Pearson correlation coefficient between RV size ratio and Ang II/Ang(1-7) was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS.|Up to Day 3|Evaluable Population.|||Unitless|||Number
2535300|NCT03212690|Secondary|Pearson Correlation Coefficient Between RV Size Ratio and Ang(1-7)|Pearson correlation coefficient between RV size ratio and Ang(1-7) was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS.|Up to Day 3|Evaluable Population.|||Unitless|||Number
2535301|NCT03212690|Secondary|Pearson Correlation Coefficient Between PASP and Ang II/Ang(1-7)|Pearson correlation coefficient between PASP and Ang II/Ang(1-7) was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS.|Up to Day 3|Evaluable Population.|||Unitless|||Number
2535302|NCT03212690|Secondary|Pearson Correlation Coefficient Between PASP and Ang(1-7)|Pearson correlation coefficient between PASP and Ang(1-7) was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS.|Up to Day 3|Evaluable Population.|||Unitless|||Number
2535304|NCT03212690|Secondary|Renin-angiotensin System Cascade Biomarker: Ang(1-7) Level|Blood samples were collected for renin-angiotensin system biomarkers at indicated time points.|Days 1, 2 and 3|Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Picograms per milliliter||Standard Deviation|Mean
2535305|NCT03212690|Secondary|Number of Participants With Severe Acute Cor Pulmonale|Severe acute cor pulmonale is defined as severely dilated RV (end-diastolic RV/LV area ratio >=1) with septal dyskinesia. Number of participants with severe acute cor pulmonale have been reported.|Days 1, 2 and 3|At risk Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2535306|NCT03212690|Secondary|Number of Participants With Acute Cor Pulmonale|Acute cor pulmonale is defined as a dilated RV in the mid-esophagus longitudinal view or apical 4-chamber view (end-diastolic RV/LV area ratio [0.6]) associated with the presence of a septal dyskinesia in the (transgastric) short-axis view of the heart. Number of participants with acute cor pulmonale have been reported.|Days 1, 2 and 3|At risk Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2535307|NCT03212690|Secondary|Number of Participants With Pulmonary Circulatory Dysfunction|Pulmonary circulatory dysfunction is defined as moderate dysfunction (pulmonary arterial systolic pressure [>40 millimeters of mercury] or a dilated RV end diastolic RV/left ventricle [LV] area ratio [>=0.6] but without septal dyskinesia). At risk Population consisted of participants who satisfied following criteria: 1. pulmonary arterial systolic pressure and ratio of RV to LV end-diastolic area recorded for all three study days [regardless of the Ang II and Ang(1-7) status] and/or; 2. databased acute cor pulmonale/pulmonary circulatory dysfunction and/or acute respiratory distress syndrome (ARDS) assessment during the study period (even if they do not have three days worth of study assessments for the echo outcomes) were evaluated for acute cor pulmonale/pulmonary circulatory dysfunction and ARDS incidence rates. Number of participants with Pulmonary Circulatory Dysfunction have been reported.|Days 1, 2 and 3|At risk Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2535308|NCT03212690|Primary|Pearson Correlation Coefficient Between RV Size Ratio and Ang II Level|Pearson correlation coefficient between RV size ratio and Ang II level was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS.|Up to Day 3|Evaluable Population.|||Unitless|||Number
2535309|NCT03212690|Primary|Pearson Correlation Coefficient Between PASP and Ang II Level|Pearson correlation coefficient between PASP and Ang II level was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using Statistical Analysis Software (SAS).|Up to Day 3|Evaluable Population.|||Unitless|||Number
2535310|NCT03212690|Primary|Inferior Vena Cava Diameter at End Expiration at Indicated Time Points|Inferior vena cava diameter was measured using TTE or TOE. Pulmonary arterial systolic pressure was estimated from trans-tricuspid pressure and right atrial pressure or inferior vena cava diameter.|Days 1, 2 and 3|Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Millimeter||Standard Deviation|Mean
2535311|NCT03212690|Primary|Right Atrial Pressure at Indicated Time Points|Right atrial pressure is the blood pressure in the right atrium of the heart. Right atrial pressure was measured by TTE or TOE.|Days 1, 2 and 3|Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Millimeters of mercury||Standard Deviation|Mean
2535312|NCT03212690|Primary|Pulmonary Arterial Systolic Pressure at Indicated Time Points|Pulmonary arterial systolic pressure was measured using TTE or TOE.|Days 1, 2 and 3|Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Millimeters of mercury||Standard Deviation|Mean
2535313|NCT03212690|Primary|Number of Participants With Paradoxical Septal Motion|Paradoxical septal motion is the systolic movement of the interventricular septum toward the RV despite normal thickening. Paradoxical septal motion was measured by TTE or TOE. Number of participants who had paradoxical septal motion have been reported.|Days 1, 2 and 3|Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2535314|NCT03212690|Primary|Ratio of RV to Left Ventricular (LV) End-diastolic Area (RV Size Ratio)|Right ventricular size ratio was measured using TTE or TOE.|Days 1, 2 and 3|Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Ratio||Standard Deviation|Mean
2535315|NCT03212690|Primary|Renin-angiotensin System Cascade Biomarker to Include Angiotensin (Ang) II Level|Blood samples were collected for renin-angiotensin system biomarkers at indicated time points. Evaluable Population consisted of all participants for whom pulmonary arterial systolic pressure (PASP), ratio of right ventricular to left ventricular end-diastolic area (RV size ratio), Ang II and Ang(1-7) data have been recorded for at least one study time point, and who did not retrospectively withdraw the consent.|Days 1, 2 and 3|Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Picograms per milliliter||Standard Deviation|Mean
2535316|NCT03212638|Primary|PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Baricitinib Following a Single Oral Dose|PK: AUC(0-∞) of Baricitinib|Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose|All participants who received at least 1 dose of study drug and had evaluable PK parameters.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2536688|NCT03159299|Secondary|Change in Diabetes Self-management From Baseline|Measured by the Summary of Diabetes Self-Care Activities questionnaire, a multi-dimensional12-item scale with items on general diet, specific diet, monitoring blood glucose, foot care, and smoking|6 months|||||||
2535317|NCT03212638|Primary|PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Baricitinib Following a Single Oral Dose|PK: AUC(0-tlast) of Baricitinib, measured in hour times nanogram per milliliter (ng*hr/mL)|Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose|All participants who received at least 1 dose of study drug and had evaluable PK parameters.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Least Squares Mean
2535318|NCT03212638|Primary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Baricitinib Following a Single Oral Dose|PK: Cmax of baricitinib after a single oral dose|Predose, 0.25 hour (hr), 0.5 hr, 0.75 hr, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 9 hr, 12 hr, 24 hr, 36 hr, 48 hr postdose|All participants who received at least 1 dose of study drug and had evaluable PK parameters.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2535319|NCT03212521|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment (Week 8) through 12 weeks after the last dose of study drug (Week 20)|Intention-to-treat population with HCV RNA < 15 IU/mL at the end of treatment, at least one post-treatment HCV RNA value, and who completed the assigned treatment.|||percentage of participants||95% Confidence Interval|Number
2535320|NCT03212521|Secondary|Percentage of Participants With On-treatment Virologic Failure|"On-treatment virologic failure was defined as one of the following conditions:~confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < 15 IU/mL during the Treatment Period; or~confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log₁₀ IU/mL above nadir) at any time point during the Treatment Period; or~HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment, where the HCV RNA value must be collected on or after Study Drug Day 36 and study drug duration ≥ 36 days."|Up to 8 weeks|Intention-to-treat population|||percentage of participants||95% Confidence Interval|Number
2535321|NCT03212521|Secondary|Percentage of Participants in the Intention-to-Treat Population With SVR12|"SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the LLOQ (15 IU/mL) 12 weeks after the last dose of study drug.~The 95% confidence interval was calculated using the normal approximation to the binomial distribution. Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 91.4%, based on the mITT threshold minus an expected 1% rate of non-virological SVR failures."|12 weeks after the last actual dose of study drug, Week 20|The intention-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2535322|NCT03212521|Primary|Percentage of Participants in the Modified Intention-to-Treat Population With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|"SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; 15 IU/mL) 12 weeks after the last dose of study drug.~The 95% confidence interval (95%CI) was calculated using the Wilson's score method.~Efficacy was to be established if the lower bound of the 95%CI was greater than the threshold of 92.4%, based on the historical rate observed in glecaprevir/pibrentasvir registrational studies in treatment-naïve, non-cirrhotic patients (98.4%) minus a margin of 6%."|12 weeks after the last actual dose of study drug, Week 20|The modified intention-to-treat (mITT) population includes all enrolled participants who received at least 1 dose of study drug, excluding participants who did not achieve SVR12 for reasons other than virologic failure, such as missing SVR12 data (5 participants) or premature study drug discontinuation (3 participants).|||percentage of participants||95% Confidence Interval|Number
2535323|NCT03212326|Secondary|Number of Subjects With Ventricular Tachycardia Mapped|If ventricular tachycardia was induced and mapped then this counts as yes|day 0 (intraoperative: data collected during the mapping procedure)|4 of 24 enrolled subjects did not inducible ventricular tachycardia; thus a total of 4 subjects did not have both scar and ventricular tachycardia mapping in order to allow scar comparison; therefore the 20 subjects with complete scar and ventricular tachycardia maps were analyzed.|||Participants|||Count of Participants
2535324|NCT03212326|Primary|Number of Subjects With Myocardial Scar on Echo and Voltage Maps|location of left ventricular myocardial scar and abnormal electrograms|day 0 (intraoperative: data collected during the mapping procedure)|3 of 24 enrolled subjects did not have voltage mapping, and 1 of 24 subjects did not have echo contrast injection; thus a total of 4 subjects did not have both echo contrast and voltage mapping in order to allow scar comparison; therefore the 20 subjects with complete echo and voltage maps were analyzed.|||Participants|||Count of Participants
2535325|NCT03212261|Secondary|Number of Participants Who Were Eligible to Provide and Provided Hair Cortisol Samples|The investigators will explore the feasibility and acceptability of collecting hair samples to examine levels of cortisol, a stress biomarker.|1 month after completing the 3RP-Lymphoma program|Of the 26 participants who participated in the program, only 20 patients were actually able to provide a hair sample. Reasons why they were no longer eligible were because they either had no hair (n=5), or because they reported taking a steroid at the time of collection (n=1).|||Participants|||Count of Participants
2535326|NCT03212261|Primary|Number of Participants Who Found the 3RP Program Acceptable|Acceptability will be assessed at the one-month follow up data collection period with five questions on the 3RP acceptability questionnaire rated on a 4-point Likert scale (1=not at all to 4=very much); higher scores mean higher levels of acceptability.|1 month after completing the 3RP-Lymphoma program||||Participants|||Count of Participants
2535327|NCT03212261|Primary|Program Feasibility: Number of Participants Who Completed at Least 75% of the Treatment Sessions|The investigators will evaluate program feasibility by examining rates of treatment completion. Participants who complete at least 75% of the treatment sessions will be identified as treatment completers.|1 month after completing the 3RP-Lymphoma program|These are people who enrolled and completed at least one 3RP-lymphoma session. This will serve as our denominator to examine the number of people who complete at least 75% of treatment sessions.|||Participants|||Count of Participants
2535328|NCT03212144|Primary|Plasma Levels of Pro-inflammatory Cytokines (IL-6 and TNF-α)|cytokines (IL-6 and TNF-α) will be collected from blood samples|at study entry|Study was terminated due to poor enrollment. No data was analyzed.||||||
2545582|NCT02940327|Primary|CD64/163|Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.|48 hours after ECMO commencement||||percentage change||Standard Deviation|Mean
2535329|NCT03211858|Secondary|Percentage of Participants With Treatment Induced, Treatment-Boosted and Treatment-Emergent Anti-insulin Aspart Antibodies (AIAs)|AIA incidence were categorized as: treatment-induced, treatment-boosted AIAs, and treatment-emergent AIA. 1) Participants with treatment-induced AIAs were those who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample. 2) Participants with treatment-boosted AIAs were those with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period). 3) Participants with treatment-emergent AIA were defined as participants with treatment-induced, or treatment-boosted AIAs.|From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52|Analysis was performed on AIA population. Here, ‘Number analyzed’ = participants included in the AIA population at Week 26 and Week 52 and with negative or missing AIA status at baseline (for treatment-induced AIA) or with positive AIA status at baseline (for treatment-boosted AIA).|||percentage of participants|||Number
2535330|NCT03211858|Secondary|Percentage of Participants With at Least One Positive Anti-Insulin Aspart Antibodies (AIA) Sample|Participants with at least one positive AIA sample at baseline or at any time during the on-treatment period (Prevalence).|From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52|Analysis was performed on AIA population, which included all participants who received at least one dose of IMP and had at least one AIA sample available for analysis during the on-treatment period, analyzed according to the treatment actually received. Here, “Number analyzed” = participants included in the AIA population at Week 26 and Week 52.|||percentage of participants|||Number
2535331|NCT03211858|Secondary|Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions|Participants with at least one treatment-emergent adverse event linked to hypersensitivity reaction and injection site reaction regardless of relationship to IMP during the main 6-month and the 12-month on-treatment periods was assessed and reported.|From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52|Analysis was performed on safety population.|||percentage of participants|||Number
2535332|NCT03211858|Secondary|Number of Hypoglycemia Events Per Participant-Year|Number of hypoglycemia events (any, severe and documented [both thresholds]) per participant-year of exposure were reported. Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (<=70 mg/dL) or plasma glucose level of <3.0 mmol/L (54 mg/dL).|From first injection of investigational medicinal product (IMP) up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52|Analysis was performed on safety population.|||events per participant-year|||Number
2535333|NCT03211858|Secondary|Number of Participants With at Least One Hypoglycemic Event|Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (<=70 mg/dL) or plasma glucose level of < 3.0 mmol/L (54 mg/dL).|From first injection of investigational medicinal product (IMP) up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52|Analysis was performed on safety population that included all randomized participants who received at least one dose of IMP, analyzed according to the treatment actually received.|||Participants|||Count of Participants
2535334|NCT03211858|Secondary|Change in 7-Point SMPG Profiles From Baseline to Week 26 and Week 52 Per Time Point|7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, Week 26, and Week 52): before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, and bedtime. For each time point, the value at each visit was calculated as the average of values obtained for the same time point across profiles performed in the week before the visit.|Baseline, Week 26, and Week 52|Analysis was performed on ITT population. Here, “Number analyzed” = participants with an available value at baseline, Week 26/Week 52 for the specified 7-point SMPG time point.|||mmol/L||Standard Deviation|Mean
2535335|NCT03211858|Secondary|Change in Postprandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 and Week 52|Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour PPG minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as the average across profiles performed in the week before the visit. All calculated values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in PPG excursions at Weeks 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a return-to-baseline multiple imputation method (values imputed as participant baseline plus an error). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae).|Baseline, Week 26, and Week 52|Analysis was performed on ITT population. Here, “Number analyzed” = participants with a baseline value for each specified category.|||mmol/L||Standard Error|Least Squares Mean
2535348|NCT03210961|Secondary|PTR (Psoriasis Cohorts)|PTR = Cmax,ss / Cmin,ss, it was summarized by dosing regimen and period.|Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose|The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2535336|NCT03211858|Secondary|Change in the Mean 24-hour Plasma Glucose Concentration From Baseline to Week 26 and Week 52|Mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in the week before a visit. All calculated values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in mean 24-hour plasma glucose concentration at weeks 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a return-to-baseline multiple imputation method (values imputed as participant baseline plus an error). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae).|Baseline, Week 26, and Week 52|Analysis was performed on ITT population. Here, “Overall number of participants analyzed” = participants with a baseline mean 24-hour plasma glucose concentration.|||mmol/L||Standard Error|Least Squares Mean
2535337|NCT03211858|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 and Week 52|All values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in FPG at Week 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae).|Baseline, Week 26, and Week 52|Analysis was performed on ITT population.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2535338|NCT03211858|Secondary|Percentage of Participants With HbA1c <7% at Week 26 and Week 52|Participants who had no available assessment at Week 26 and Week 52 were considered as non-responders.|Week 26, and Week 52|Analysis was performed on ITT population.|||percentage of participants|||Number
2535339|NCT03211858|Secondary|Change in HbA1c From Baseline to Week 52|All values up to Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c was calculated by subtracting baseline value from Week 52 value. Missing changes at Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA model on data obtained from the multiple imputations (results were combined using Rubin's formulae).|Baseline, Week 52|Analysis was performed on ITT population.|||percentage of HbA1c||Standard Error|Least Squares Mean
2535340|NCT03211858|Primary|Change in Glycated Hemoglobin A1c (HbA1c) From Baseline to Week 26|All values up to Week 26 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing changes at Week 26 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted least square (LS) means and standard errors (SE) were obtained using an analysis of covariance (ANCOVA) model on data obtained from the multiple imputations (results were combined using Rubin's formulae).|Baseline, Week 26|Analysis was performed on intent-to-treat (ITT) population, which included all randomized participants, irrespective of compliance with the study protocol and procedures.|||percentage of HbA1c||Standard Error|Least Squares Mean
2535341|NCT03211117|Other Pre-specified|Numbers of Patients With Distant Metastasis|Will be summarized using descriptive statistics.|Up to 5 years|||||||
2535342|NCT03211117|Other Pre-specified|Number of Patients With Locoregional Recurrence and Locoregional Progression in the Thyroid Bed or Regional Lymph Nodes|Will be summarized using descriptive statistics.|2.3 years||||Participants|||Count of Participants
2535343|NCT03211117|Secondary|Incidence of Adverse Events Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. This data is reported in the adverse events section of this report.|2.3 years||||Participants|||Count of Participants
2535344|NCT03211117|Primary|Overall Survival Rate|Defined as the percentage of evaluable patients who are alive at 6 months.|At 6 months|All patients|||percentage of participants alive|||Number
2535345|NCT03210961|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 28|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.|Baseline and Day 28|The analysis population included psoriasis participants who received the 28-day study treatment and who had the efficacy parameters at Baseline and on Day 28 in the Psoriasis Cohorts. Data in SAD/MAD Periods were not included.|||score on a scale||Standard Error|Least Squares Mean
2535346|NCT03210961|Secondary|CL/F (Psoriasis Cohorts)|CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose|The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2535347|NCT03210961|Secondary|Vz/F (Psoriasis Cohorts)|Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose|The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.|||liters (L)||Geometric Coefficient of Variation|Geometric Mean
2535349|NCT03210961|Secondary|MRT (Psoriasis Cohorts)|MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity.|Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24,168 hours post-dose|The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.|||hours (hr)||Geometric Coefficient of Variation|Geometric Mean
2535350|NCT03210961|Secondary|Terminal Elimination Half-Life ((t½) (Psoriasis Cohorts)|t1/2 was summarized by dosing regimen and period. It was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.|Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24,168 hours post-dose|The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.|||hours (hr)||Standard Deviation|Mean
2535351|NCT03210961|Secondary|Cmin (Psoriasis Cohorts)|Cmin was observed directly from data. It was summarized by dosing regimen and period.|Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose|The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2535352|NCT03210961|Secondary|Cav (Psoriasis Cohorts)|Cav = AUCτ,ss / τ, where ss means 'at steady state'. Cav was summarized by dosing regimen and period.|Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose|The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2535353|NCT03210961|Secondary|Tmax (Psoriasis Cohorts)|Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.|Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose|The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.|||hours (hr)||Full Range|Median
2535354|NCT03210961|Secondary|Cmax(dn) (Psoriasis Cohorts)|Cmax was summarized by dosing regimen and period. It was observed directly from data.|Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose|The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2535355|NCT03210961|Secondary|Cmax (Psoriasis Cohorts)|Cmax was summarized by dosing regimen and period. It was observed directly from data.|Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose|The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2535356|NCT03210961|Secondary|AUCτ(dn) (Psoriasis Cohorts)|AUCτ(dn) = AUCτ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCτ was plotted against dose, and included individual participant values and the geometric means for each dose.|Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose|The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.|||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2535357|NCT03210961|Secondary|AUCτ (Psoriasis Cohorts)|AUCτ was summarized by dosing regimen and period. It was determined by linear/log trapezoidal method.|Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose|The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2535358|NCT03210961|Secondary|Renal Clearance (Clr) (MAD Period Day 10)|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Aeτ) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCτ), where dosing interval is 24 hours for QD dosing and 12 hours for BID dosing.|Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2535359|NCT03210961|Secondary|Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ%) (MAD Period Day 10)|Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing. Aeτ% = Aeτ / Dose * 100. Aeτ%was summarized by dosing regimen and period.|Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||Percentage of Dose||Geometric Coefficient of Variation|Geometric Mean
2535360|NCT03210961|Secondary|Cumulative Amount of Drug Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ) (MAD Period Day 10)|Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing. Aeτ = Sum of [urine concentration * sample volume] for each collection interval. Aer was summarized by dosing regimen and period.|Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||mg||Geometric Coefficient of Variation|Geometric Mean
2535361|NCT03210961|Secondary|CL/F (MAD Period Day 10)|CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2535362|NCT03210961|Secondary|Vz/F (MAD Period Day 10)|Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||liters (L)||Geometric Coefficient of Variation|Geometric Mean
2535363|NCT03210961|Secondary|Observed Accumulation Ratio Based on Cmax (Rac,Cmax) (MAD Period Day 10)|Rac,Cmax = Cmax,ss / Cmax,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac,Cmax = Cmax(Day10) / Cmax(Day 1). Rac,Cmax was summarized by dosing regimen and period.|Days 1 and 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2535364|NCT03210961|Secondary|Observed Accumulation Ratio Based on AUC (Rac) (MAD Period Day 10)|Rac = AUCτ,ss / AUCτ,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac = AUCτ(Day 10) / AUCτ(Day 1). Rac was summarized by dosing regimen and period.|Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2535365|NCT03210961|Secondary|Peak Trough Ratio (PTR) (MAD Period Day 10)|PTR = Cmax,ss / Cmin,ss, where ss means 'at steady state'. It was summarized by dosing regimen and period.|Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2535366|NCT03210961|Secondary|MRT (MAD Period Day 10)|MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity.|Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24,48,72,96,168 hours post-dose|The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||hours (hr)||Geometric Coefficient of Variation|Geometric Mean
2535367|NCT03210961|Secondary|Terminal Elimination Half-Life ((t½) (MAD Period Day 10)|t1/2 was summarized by dosing regimen and period. It was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.|Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24,48,72,96,168 hours post-dose|The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||hours (hr)||Standard Deviation|Mean
2535368|NCT03210961|Secondary|Lowest Concentration Observed During the Dosing Interval τ (Cmin) (MAD Period Day 10)|Cmin was observed directly from data. It was summarized by dosing regimen and period. Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing.|Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2535369|NCT03210961|Secondary|Average Concentration at Steady State (Cav) (MAD Period Day 10)|Cav = AUCτ,ss / τ, where ss means 'at steady state', and where the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing. Cav was summarized by dosing regimen and period.|Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2535370|NCT03210961|Secondary|Tmax (MAD Period Day 10)|Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.|Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||hours (hr)||Full Range|Median
2535371|NCT03210961|Secondary|Cmax(dn) (MAD Period Day 10)|Cmax(dn) = Cmax / dose. To assess the relationship between Cmax and dose, dose normalized Cmax was plotted against dose, and included individual participant values and the geometric means for each dose.|Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2535372|NCT03210961|Secondary|Cmax (MAD Period Day 10)|Cmax was summarized by dosing regimen and period. It was observed directly from data.|Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2535373|NCT03210961|Secondary|AUCτ(dn) (MAD Period Day 10)|"Area Under the Plasma Concentration-Time Profile over the Dosing interval τ (AUCτ). Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing.~AUCτ(dn) = AUCτ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCτ was plotted against dose, and included individual participant values and the geometric means for each dose."|Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2535374|NCT03210961|Secondary|AUCτ (MAD Period Day 10)|AUCτ was summarized by dosing regimen and period. Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval was 24 hours for QD dosing and 12 hours for BID dosing. It was determined by linear/log trapezoidal method.|Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2535375|NCT03210961|Secondary|Tmax (MAD Period Day 1)|Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.|Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||hours (hr)||Full Range|Median
2535376|NCT03210961|Secondary|Cmax(dn) (MAD Period Day 1)|Cmax(dn) = Cmax / dose. To assess the relationship between Cmax and dose, dose normalized Cmax was plotted against dose, and included individual participant values and the geometric means for each dose.|Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2535377|NCT03210961|Secondary|Cmax (MAD Period Day 1)|Cmax was summarized by dosing regimen and period. It was observed directly from data.|Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2535378|NCT03210961|Secondary|Dose Normalized AUCτ (AUCτ[dn]) (MAD Period Day 1)|"Area Under the Plasma Concentration-Time Profile over the Dosing interval τ (AUCτ). Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing.~AUCτ(dn) = AUCτ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCτ was plotted against dose, and included individual participant values and the geometric means for each dose."|Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2535379|NCT03210961|Secondary|Area Under the Plasma Concentration-Time Profile Over the Dosing Interval τ (AUCτ) (MAD Period Day 1)|AUCτ was summarized by dosing regimen and period. Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval was 24 hours for QD dosing and 12 hours for BID dosing. It was determined by linear/log trapezoidal method.|Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included healthy participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2535380|NCT03210961|Secondary|Apparent Clearance (CL/F) (SAD Period)|CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose|The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.|||liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2535381|NCT03210961|Secondary|Apparent Volume of Distribution (Vz/F) (SAD Period)|Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose|The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.|||liters (L)||Geometric Coefficient of Variation|Geometric Mean
2535382|NCT03210961|Secondary|Mean Residence Time (MRT) (SAD Period)|MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity.|Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose|The analysis population included healthy participants who received the study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.|||hours (hr)||Geometric Coefficient of Variation|Geometric Mean
2535383|NCT03210961|Secondary|Terminal Elimination Half-Life ((t½) (SAD Period)|t1/2 was summarized by dosing regimen and period. It was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.|Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose|The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.|||hours (hr)||Standard Deviation|Mean
2535384|NCT03210961|Secondary|Time for Cmax (Tmax) (SAD Period)|Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.|Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose|The analysis population included healthy participants who received the study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.|||hours (hr)||Full Range|Median
2535385|NCT03210961|Secondary|Dose Normalized Cmax (Cmax[dn]) (SAD Period)|Cmax(dn) = Cmax / dose. To assess the relationship between Cmax and dose, dose normalized Cmax was plotted against dose, and included individual participant values and the geometric means for each dose.|Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose|The analysis population included healthy participants who received the study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2535386|NCT03210961|Secondary|Maximum Plasma Concentration (Cmax) (SAD Period)|Cmax was summarized by dosing regimen and period. It was observed directly from data.|Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose|The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2535387|NCT03210961|Secondary|Dose Normalized AUClast (AUClast[dn]) (SAD Period)|AUClast(dn) = AUClast / dose. Dose normalized AUC values of PF-06826647 were plotted against dose and included individual participant values and the geometric means for each dose. These plots was used to help understand the relationship between the plasma PK parameters and dose.|Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose|The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.|||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2535388|NCT03210961|Secondary|Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) (SAD Period)|AUClast was summarized by dosing regimen and period. It was determined by linear/log trapezoidal method.|Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose|The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2535389|NCT03210961|Secondary|Area Under the Concentration-Time Profile From Time 0 to 24 Hours (AUC24) (SAD Period)|AUC24 was summarized by dosing regimen and period. It was determined by linear/log trapezoidal method.|Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose|The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2535390|NCT03210961|Secondary|Secondary: Dose Normalized AUCinf (AUCinf[dn]) (SAD Period)|AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). AUCinf(dn) = AUCinf / dose. Dose normalized AUC values of PF-06826647 was plotted against dose and included individual participant values and the geometric means for each dose. These plots were used to help understand the relationship between the plasma PK parameters and dose.|Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose|The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.|||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2535391|NCT03210961|Secondary|Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) (SAD Period)|AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).|Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose|The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.|||nanograms*hours per mL (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2535392|NCT03210961|Primary|Change in 24 Hour Creatinine Clearance From Day -1 on Day 10 (MAD Period)|Change in 24-hour creatinine clearance at Day 10 from Day -1 (baseline) during the MAD was presented by treatment group.|Day -1 and Day 10|The analysis population included the healthy participants who received study treatment in the MAD Period. The PBO QD MAD sequence is comprised of both non-Japanese and Japanese participants. The non-Japanese participants had completed the SAD period and continued into the MAD period. The Japanese participants took part only in the MAD period.|||milliliters per minute (mL/min)||Standard Deviation|Mean
2535393|NCT03210961|Primary|Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)|Laboratory data were listed and summarized by treatment in accordance with the sponsor reporting standards. Parameters and corresponding primary criteria for laboratory abnormalities evaluation included: reticulocytes/erythrocytes (%) >1.5 × ULN, lymphocytes <0.8 × LLN, neutrophils <0.8 × LLN or >1.2 × ULN, eosinophils >1.2 × ULN, bilirubin >1.5 × ULN, alanine aminotransferase (ALT) >3.0 × ULN, creatinine >1.3 × ULN, urate >1.2 × ULN, HDL cholesterol <0.8 × LLN, LDL cholesterol >1.2 × ULN, triglycerides >1.3 × ULN, potassium >1.1 × ULN, bicarbonate >1.1 × ULN, glucose <0.6 × LLN or >1.5 × ULN, Creatine Kinase (CK) >2.0 × ULN, cholesterol >1.3 × ULN, urine glucose ≥1, ketones ≥1, urine hemoglobin ≥1, urine bilirubin ≥1, leukocyte esterase ≥1, epithelial cells ≥6/LPF, urinalysis-bacteria/HPF.|Baseline up to Day 56|The analysis population included the psoriasis participants who received study treatment and who had the safety parameters in the Psoriasis Cohorts. Data in SAD/MAD Periods were not included.|||Participants|||Count of Participants
2535407|NCT03210961|Primary|Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period)|"Maximum absolute values and changes from baseline for vital signs (for supine systolic/diastolic blood pressure [BP] and supine pulse rate [PR]) were summarized descriptively by treatment. Numbers of participants meeting the categorical criteria were provided.~Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts."|Baseline up to Day 8|The analysis population included the healthy participants who received study treatment and who had the safety parameters in the SAD Period. MAD and Psoriasis Cohorts data were not included.|||Participants|||Count of Participants
2535408|NCT03210376|Secondary|Length of Hospital Stay||length of hospital stay(average of 3 days)||||days||Standard Deviation|Mean
2535394|NCT03210961|Primary|Number of Participants With Laboratory Abnormalities (MAD Period)|Laboratory data were listed and summarized by treatment in accordance with the sponsor reporting standards. Parameters and corresponding primary criteria for laboratory abnormalities evaluation included: Ery. MCV <0.9 × LLN, Ery. Mean corpuscular hemoglobin (Ery. MCH) <0.9 × LLN or >1.1 ULN, reticulocytes/erythrocytes (%) >1.5 × ULN, lymphocytes <0.8 × LLN or >1.2 × ULN, neutrophils <0.8 × LLN, eosinophils >1.2 × ULN, bilirubin >1.5 × ULN, urate >1.2 × ULN, HDL cholesterol <0.8 × LLN, LDL cholesterol >1.2 × ULN, triglycerides >1.3 × ULN, bicarbonate >1.1 × ULN, cholesterol >1.3 × ULN, urine glucose ≥1, urine hemoglobin ≥1, nitrite ≥1, leukocyte esterase ≥1, epithelial cells ≥6/LPF, urinalysis-casts >1/LPF, urinalysis-bacteria >20/HPF, urine 24 hours creatinine >1.1 × ULN.|Baseline up to Day 28|The analysis population included the healthy participants who received study treatment in the MAD Period. The PBO QD MAD sequence is comprised of both non-Japanese and Japanese participants. The non-Japanese participants had completed the SAD period and continued into the MAD period. The Japanese participants took part only in the MAD period.|||Participants|||Count of Participants
2535395|NCT03210961|Primary|Number of Participants With Laboratory Abnormalities (SAD Period)|"Laboratory data were listed and summarized by treatment in accordance with the sponsor reporting standards. Parameters for laboratory abnormalities evaluation included: erythrocyte mean corpuscular volume (Ery. MCV), erythrocyte mean corpuscular hemoglobin (Ery. MCH), reticulocytes/erythrocytes (%), limphocytes, eosinophils, bilirubin, aspartate aminotransferase (AST), urate, high-density lipoproteins (HDL) cholesterol, low-density lipoproteins (LDL) cholesterol, triglycerides, cholesterol, ketones, nitrite, leukocyte esterase, epithelial cells, urinalysis-bacteria.~Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts."|Baseline up to Day 8|The analysis population included the healthy participants who received study treatment and who had the safety parameters in the SAD Period. MAD and Psoriasis Cohorts data were not included.|||Participants|||Count of Participants
2535396|NCT03210961|Primary|Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. All events occurring following start of the treatment or increasing in severity were counted as treatment emergent. Events that occurred in a non-treatment period (eg, washout or follow-up) were counted as treatment emergent and attributed to the previous treatment taken. For each event, the investigator pursued and obtained adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE.|Baseline up to Day 84|The analysis population included the psoriasis participants who received study treatment and who had the safety parameters in the Psoriasis Cohorts. Data in SAD/MAD Periods were not included.|||Participants|||Count of Participants
2535397|NCT03210961|Primary|Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. All events occurring following start of the treatment or increasing in severity were counted as treatment emergent. Events that occurred in a non-treatment period (eg, washout or follow-up) were counted as treatment emergent and attributed to the previous treatment taken. For each event, the investigator pursued and obtained adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE.|Baseline up to Day 28|The analysis population included the healthy participants who received study treatment in the MAD Period. The PBO QD MAD sequence is comprised of both non-Japanese and Japanese participants. The non-Japanese participants had completed the SAD period and continued into the MAD period. The Japanese participants took part only in the MAD period.|||Participants|||Count of Participants
2535398|NCT03210961|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period)|"An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. All events occurring following start of the treatment or increasing in severity were counted as treatment emergent. Events that occurred in a non-treatment period (eg, washout or follow-up) were counted as treatment emergent and attributed to the previous treatment taken. For each event, the investigator pursued and obtained adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE.~PBO SAD cohorts = [PBO SAD (3mg, 10mg)] cohorts + [PBO SAD -> PBO QD MAD] cohorts."|Baseline up to Day 8|The analysis population included the healthy participants who received study treatment and who had the safety parameters in the SAD Period. MAD and Psoriasis Cohorts data were not included.|||Participants|||Count of Participants
2535399|NCT03210961|Primary|Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)|ECG endpoints and changes from baseline (QTcF, PR and QRS) were summarized descriptively by cohort and treatment using pre-defined categories. Numbers of participants meeting the categorical criteria were provided. All planned and unplanned post-dose time points were counted in these categorical summaries. Categorical summarization criteria for ECG were as follows: 1) QTcF maximum absolute value ≥450 and <480 millisecond (msec), ≥480 and <500 msec. ≥500 msec; 2) QTcF maximum increase ≥30 and <60 msec, ≥60 msec; 3) PR maximum absolute value ≥300 msec; 4) PR maximum increases from baseline ≥25% if baseline >200 msec, ≥50% if baseline ≤200 msec; 5) QRS maximum absolute value ≥140 msec; 6) QRS maximum increase from baseline ≥50%.|Baseline up to Day 56|The analysis population included the psoriasis participants who received study treatment and who had the safety parameters in the Psoriasis Cohorts. Data in SAD/MAD Periods were not included.|||Participants|||Count of Participants
2535409|NCT03210376|Secondary|Surgical Exposure Grading||Day 0 - IntraOperative, from incision time to closing time(average 190 minutes)||||Participants|||Count of Participants
2535400|NCT03210961|Primary|Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period)|ECG endpoints and changes from baseline (QTcF, PR and QRS) were summarized descriptively by cohort and treatment using pre-defined categories. Numbers of participants meeting the categorical criteria were provided. All planned and unplanned post-dose time points were counted in these categorical summaries. Categorical summarization criteria for ECG were as follows: 1) QTcF maximum absolute value ≥450 and <480 millisecond (msec), ≥480 and <500 msec. ≥500 msec; 2) QTcF maximum increase ≥30 and <60 msec, ≥60 msec; 3) PR maximum absolute value ≥300 msec; 4) PR maximum increases from baseline ≥25% if baseline >200 msec, ≥50% if baseline ≤200 msec; 5) QRS maximum absolute value ≥140 msec; 6) QRS maximum increase from baseline ≥50%.|Baseline up to Day 28|The analysis population included the healthy participants who received study treatment in the MAD Period. The PBO QD MAD sequence is comprised of both non-Japanese and Japanese participants. The non-Japanese participants had completed the SAD period and continued into the MAD period. The Japanese participants took part only in the MAD period.|||Participants|||Count of Participants
2535401|NCT03210961|Primary|Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period)|"ECG endpoints and changes from baseline (QTcF, PR and QRS) were summarized descriptively by cohort and treatment using pre-defined categories. Numbers of participants meeting the categorical criteria were provided. All planned and unplanned post-dose time points were counted in these categorical summaries. Categorical summarization criteria for ECG were as follows: 1) QTcF maximum absolute value ≥450 and <480 millisecond (msec), ≥480 and <500 msec. ≥500 msec; 2) QTcF maximum increase ≥30 and <60 msec, ≥60 msec; 3) PR maximum absolute value ≥300 msec; 4) PR maximum increases from baseline ≥25% if baseline >200 msec, ≥50% if baseline ≤200 msec; 5) QRS maximum absolute value ≥140 msec; 6) QRS maximum increase from baseline ≥50%.~Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts."|Baseline up to Day 8|The analysis population included the healthy participants who received study treatment and who had the safety parameters in the SAD Period. MAD and Psoriasis Cohorts data were not included.|||Participants|||Count of Participants
2535402|NCT03210961|Primary|Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)|Physical examinations were conducted by a physician, trained physician assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.|Baseline up to Day 56|The analysis population included the psoriasis participants who received study treatment and who had the safety parameters in the Psoriasis Cohorts. Data in SAD/MAD Periods were not included.|||Participants|||Count of Participants
2535403|NCT03210961|Primary|Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period)|Physical examinations were conducted by a physician, trained physician assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.|Baseline up to Day 28|The analysis population included the healthy participants who received study treatment in the MAD Period. The PBO QD MAD sequence is comprised of both non-Japanese and Japanese participants. The non-Japanese participants had completed the SAD period and continued into the MAD period. The Japanese participants took part only in the MAD period.|||Participants|||Count of Participants
2535404|NCT03210961|Primary|Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)|"Physical examinations were conducted by a physician, trained physician assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.~Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts."|Baseline up to Day 8|The analysis population included the healthy participants who received study treatment and who had the safety parameters in the SAD Period. MAD and Psoriasis Cohorts data were not included.|||Participants|||Count of Participants
2535405|NCT03210961|Primary|Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)|Maximum absolute values and changes from baseline for vital signs (for supine systolic/diastolic blood pressure and supine pulse rate) were summarized descriptively by treatment. Numbers of participants meeting the categorical criteria were provided.|Baseline up to Day 56|The analysis population included the psoriasis participants who received study treatment and who had the safety parameters in the Psoriasis Cohorts. Data in SAD/MAD Periods were not included.|||Participants|||Count of Participants
2535406|NCT03210961|Primary|Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period)|Maximum absolute values and changes from baseline for vital signs (for supine systolic/diastolic blood pressure and supine pulse rate) were summarized descriptively by treatment. Numbers of participants meeting the categorical criteria were provided.|Baseline up to Day 28|The analysis population included the healthy participants who received study treatment in the MAD Period. The PBO QD MAD sequence is comprised of both non-Japanese and Japanese participants. The non-Japanese participants had completed the SAD period and continued into the MAD period. The Japanese participants took part only in the MAD period.|||Participants|||Count of Participants
2535410|NCT03210376|Secondary|Percentage of Participants With Nausea and/or Vomiting in PACU|Degree of Post-Operative Nausea determined per Visual Analog Scale per nurse in Post-Anesthesia Care Unit (PACU).|Day 0 - PACU stay, an average of 120 minutes||||percentage of participants|||Number
2539487|NCT03070730|Secondary|Change in Physical Functioning-FSS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Fatigue Severity Scale.|1 week after first intervention|||||||
2535411|NCT03210376|Secondary|Readiness to Discharge From the Post-Anesthesia Care Unit (PACU)|Determined by the Dansk Selskab for Anæstesiologi og Intensiv Medicin(DASAIM)discharge criteria.Pts considered ready to discharge when the sum of all categories is<4 and no single category has a score of >1.Sedation.0:Patient is fully awake.1: Patient is asleep,aroused by verbal stimulation.2:Patient is asleep, aroused by physical stimulation.3:Patient is asleep,cannot be aroused.Respiratory Rate.0:Respiratory rate>10. 1: Snoring,10< RR<30. 2:R<10 or RR>30/min.3:Periods of apnea or obstructive patterns.Oxygen Saturation.0:SpO2 ≥ 94%.1:90%≤SpO2<94%. 2:85%≤ SpO2 < 90%.3:SpO2 < 85%. Systolic Blood Pressure. 0:SBP ≥ 100mmHg.1:90mmHg≤SBP< 100mmHg.2:80mmHg≤SBP< 90mmHg or SBP>220mmHg.3:SBP<80mmHg.Heart Rate.0:50<HR≤100.1:100<HR≤120.2:40<HR≤ 50 or 120<HR≤130.3:HR<40 or HR>130.Pain at rest.0:No pain 1:Light pain.2:Moderate pain.3:Severe pain.Nausea.0:No nausea or vomiting.1:Light nausea or vomiting without previous nausea. 2:Moderate nausea and/or vomiting.3:Severe nausea and/or vomiting.|Assessed at 15, 45, 90 minutes during PACU stay.||||Score on a scale||Standard Deviation|Median
2535412|NCT03210376|Secondary|Percentage of Muscle Response Using Train-of-Four (TOF) in Post-Anesthesia Care Unit (PACU) to Measure Residual Muscle Relaxation|The patients will be started on a continuous Rocuronium intravenous infusion following intubation. Insert recommendations and Institutional Standards will be used for Rocuronium. For the DNMB group, the rate will be adjusted and boluses given to maintain 1-2 post tetanic responses during the pneumoperitoneum. NMB will be reversed with Sugammadex 4 mg/Kg, intravenously as a single bolus injection, at the end of the surgery. Percentage of measured contraction strength of the fourth stimulus compared to the first stimulus.|Day 0 - Arrival time at PACU, an average of 3 minutes||||Percentage of measured contraction||Full Range|Median
2535413|NCT03210376|Secondary|Cumulative Intraoperative Insufflation Pressure|Intra-abdominal insufflation time and pressure directed by the surgeon and recorded continuously by the clinical coordinator until the time of desufflation.|Day 0 - IntraOperative-From beginning of pneumoperitoneum to desufflation (an average of 166 minutes)||||mmHg||Full Range|Median
2535414|NCT03210376|Primary|Percentage of Patients Who Reported Shoulder Pain|Visual Analog Scale (VAS) pain score (0-10) for shoulder pain recorded, where 0 means no pain and 10 means the worst pain ever experienced . Percentage of participants who experienced should pain.|30 days||||percentage of participants|||Number
2535415|NCT03210337|Primary|Mean Change in Physician's Wart Assessment Score From Baseline to Day 57|"Physician's Wart Assessment Grade Descriptor 0 Clear: No visible wart. No further treatment is indicated.~Near Clear: A visible wart that is less than 3 mm in maximal diameter (or length)~A visible wart ≥ 3 mm and < 6 mm in maximal diameter (or length)~A visible wart ≥ 6 mm in maximal diameter (or length)"|Day 57|PP|||score on a scale (PWA)||Standard Deviation|Mean
2535416|NCT03210220|Primary|Intraoperative Remifentanil Consumption|Intraoperative remifentanil consumption during surgery(whole intraoperative period)|whole intraoperative period||||μg/kg/h||Standard Deviation|Mean
2535417|NCT03209570|Secondary|Number of Brief Changes Per 24 Hours|The number of brief changes per 24 hours, intervention versus control|6 days||||events per 24 hours||Standard Error|Least Squares Mean
2535418|NCT03209570|Secondary|Time Wet Per 24 Hours|Comparison of the amount of time wet per 24 hours as recorded by TENA Identifi, intervention versus control|6 days||||hours per 24 hours||Standard Error|Least Squares Mean
2535419|NCT03209570|Primary|Wet Events Per 24 Hours|Comparison of the number of wet events per 24 hours as recorded by TENA Identifi, intervention versus control|6 days|The study design is a two group, two time-point, four site, randomized, longitudinal clinical trial. Means were generated by averaging the 3 daily counts in each assessment period (pre-intervention and post-intervention) for each group (control versus intervention).|||events per 24 hours||Standard Error|Least Squares Mean
2535420|NCT03209518|Secondary|Percentage of Participants Who Had One or More Adverse Reactions|Adverse drug reaction refers to adverse events related to the administered drug.|Up to Week 24|Safety Analysis Set, The safety analysis set was defined as participants who were evaluable for the safety without major protocol deviation within those who administered the survey drug.|||Percentage of Participants|||Number
2535421|NCT03209518|Primary|Percentage of Participants Who Had One or More Adverse Events||Up to Week 24|Safety Analysis Set, The safety analysis set was defined as participants who were evaluable for the safety without major protocol deviation within those who administered the survey drug.|||Percentage of Participants|||Number
2535422|NCT03209492|Secondary|Percentage of Participants Who Had One or More Adverse Reactions|Adverse drug reaction refers to adverse events related to the administered drug.|Up to Week 24|Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.|||Percentage of Participants|||Number
2535423|NCT03209492|Primary|Percentage of Participants Who Had One or More Adverse Events||Up to Week 24|Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.|||Percentage of Participants|||Number
2535424|NCT03208673|Secondary|Change From Baseline in Visual Analogue Scale (VAS): Symptomatology Upon Waking|The participant rated the severity of their symptomatology upon waking using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line) = no symptoms to 100 (far right on the line) = most severe symptoms.|Baseline (day 0) to (day 30 +/- 3 days)||||scores on a scale||Standard Deviation|Mean
2535425|NCT03208673|Primary|Measured Lissamine Green Bulbar Conjunctival Staining (mm2)|The Lissamine Green (LG) bulbar conjunctival staining was analysed post-hoc for both eyes. The photos were masked and for each image the Staining Area was measured (mm2).|Change from baseline to (day 30 +/- 3 days)||||mm2||Standard Deviation|Mean
2535426|NCT03208673|Primary|Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score|A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.|Change from baseline to (day 30 +/- 3 days)||||Scores on a scale||Standard Deviation|Mean
2535758|NCT03194490|Primary|Cervical Range of Motion|The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline,week two, four and eight.|Participants ROM measurement at week 8||||Degree||Standard Error|Mean
2535427|NCT03208166|Primary|Change in Putative Blood Biomarkers|Change in the absolute levels of the following biomarkers will be measured from baseline to 30 days: Nitrite, IL-10, SDF1, Micro RNA 144. Lp-PLA2, IL-6. hsCRP, Soluble E selectin, ICAm, MMP-9, PAI-1,tPA, ADMA|30 days|Since recruitment in the trial was terminated early and there were only 2 patients enrolled, one in the conditioning arm and one in the standard of care arm, a decision was made not to do these experimental biomarkers (which are done in batch) since interpretating the results would be challenging with just one patient in each arm.||||||
2535428|NCT03208166|Primary|Percent Change in Cerebral Blood Flow (CBF)|Percent change CBF from baseline to 30 days as determined by ASL MRI imaging.|Baseline and 30 days||||percentage increase in CBF|||Number
2535429|NCT03207776|Secondary|30-day COPD Specific, Acute Care Utilization to Any Hospital Within the System||30 day||||Participants|||Count of Participants
2535430|NCT03207776|Secondary|Patient-centric (Protocol Defined) Readmission Rate|Readmission to any facility within Carolinas HealthCare System|30 days||||Participants|||Count of Participants
2535431|NCT03207776|Secondary|Quality, Comfort, and Care (QCC) Defined Readmission Rate|Readmission to the same facility|30 days||||Participants|||Count of Participants
2535432|NCT03207776|Primary|Healthcare Utilization|Occurrence of Emergency Department, inpatient, or observation encounters after the initial encounter at accrual|60 days||||Participants|||Count of Participants
2535433|NCT03207750|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs).|SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity.|During the entire study period (Day 1 to Month 10)|Analysis was performed on the Exposed set (ES). The ES included all subjects with at least one study vaccine administration documented. A safety analysis based on the ES included all vaccinated subjects.|||Participants|||Count of Participants
2535434|NCT03207750|Secondary|Number of Subjects With Any Unsolicited AEs.|Unsolicited AEs assessed include any AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any= Any unsolicited AE irrespective of its intensity grade and relationship to vaccination.|During the 31-day (Days 1-31) follow-up period after each HRV vaccination.|Analysis was performed on the Exposed set (ES). The ES included all subjects with at least one study vaccine administration documented. A safety analysis based on the ES included all vaccinated subjects.|||Participants|||Count of Participants
2535435|NCT03207750|Secondary|Number of Subjects With Any Solicited General Adverse Events (AEs).|Assessed solicited general AEs were cough/runny nose; diarrhoea; fever measured by 3 routes which were oral, axillary and rectal, defined as temperature ≥ 38.0 degrees Celsius (°C); irritability; loss of appetite and vomiting. Any = any solicited general AE irrespective of its intensity grade and relationship to vaccination|During the 8-day (Days 1-8) follow-up period after each HRV vaccination.|Analysis was performed on the Exposed set (ES). The ES included all subjects with at least one study vaccine administration documented. A safety analysis based on the ES included all vaccinated subjects.|||Participants|||Count of Participants
2535436|NCT03207750|Secondary|Immunogenicity in Terms of Anti-poliovirus Types 1, 2 and 3 Antibody Titers.|Antibody concentrations against Poliovirus types 1, 2 and 3 were determined and expressed as Geometric Mean Titers (GMTs).|At Month 5 (One month after Dose 3 of co-administered vaccines)|Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.|||Titers||95% Confidence Interval|Geometric Mean
2535437|NCT03207750|Secondary|Immunogenicity in Terms of Anti-HBs Antibody Concentrations.|Antibody concentrations against Hepatitis B were determined and expressed as GMCs. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.|At Month 5 (One month after Dose 3 of co-administered vaccines)|Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.|||mIU/mL||95% Confidence Interval|Geometric Mean
2535438|NCT03207750|Secondary|Immunogenicity in Terms of Anti-PRP Antibody Concentrations.|Antibody concentrations against PRP were determined and expressed as GMCs. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.|At Month 5 (One month after Dose 3 of co-administered vaccines)|Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.|||µg/mL||95% Confidence Interval|Geometric Mean
2535439|NCT03207750|Secondary|Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations.|Antibody concentrations against diphtheria and tetanus were determined and expressed as GMCs. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.|At Month 5 (One month after Dose 3 of co-administered vaccines)|Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.|||IU/mL||95% Confidence Interval|Geometric Mean
2535440|NCT03207750|Secondary|Number of Seropositive Subjects With Anti-PnPS Antibody Concentrations Above or Equal to Cut-off Value.|Immunogenicity was assessed using ELISA technique in terms of seropositivity against Pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) antibodies. The cut-off used was ≥ 0.35 µg/mL.|At Month 5 (One month after Dose 3 of co-administered vaccines)|Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.|||Participants|||Count of Participants
2538103|NCT03112993|Primary|Difference in Time of Neuromuscular Recovery From a Neuromuscular Moderate Blockade|Speed of neuromuscular recovery in minutes measured by recovery of the T4:T1 ratio ≥ 0.9 (measured with a TOF-Watch SX)|Day 1||||Minutes||Standard Deviation|Mean
2535441|NCT03207750|Secondary|Number of Seropositive Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above or Equal to Cut-off Value.|"Immunogenicity was assessed using ELISA technique in terms of seropositivity against PT, FHA and PRN antibodies. The cut-offs for antibodies were the Lower Limit Of Quantification (LLOQ) of the assays which were ≥ 2.693 IU/mL (anti-PT), ≥ 2.046 IU/mL (anti-FHA) and ≥ 2.187 IU/mL (anti-PRN).~The Limit of Quantification is the lowest analyte concentration that can be quantitatively detected with a stated accuracy and precision, and LLOQ is the lowest standard curve point obtained by extrapolation, that can still be used for quantification."|At Month 5 (One month after Dose 3 of co-administered vaccines)|Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.|||Participants|||Count of Participants
2535442|NCT03207750|Secondary|Number of Seropositive Subjects With Anti-RV IgA Antibody Concentrations Above or Equal to Cut-off Value of 90 U/mL.|Immunogenicity was assessed in terms of seropositivity against Rota virus IgA antibodies. The cut off used was ≥ 90 U/mL.|At Month 5 (Three months after Dose 2 of HRV vaccine)|Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.|||Participants|||Count of Participants
2535443|NCT03207750|Secondary|Number of Seropositive Subjects With Anti-Rota Virus Immunoglobulin A (Anti-RV IgA) Antibody Concentrations Above or Equal to Cut-off Value of 20 Units/Milliliter (U/mL).|Immunogenicity was assessed in terms of seropositivity against Rota virus IgA antibodies. The cut off used was ≥ 20 U/mL.|At Month 5 (Three months after Dose 2 of HRV vaccine)|Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.|||Participants|||Count of Participants
2535444|NCT03207750|Primary|Number of Subjects With Seroresponse to Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibodies.|Seroresponse is defined as the percentage of subjects showing an antibody concentration above a threshold that leads to 95% seroresponse in the HRV lyophilized Group. The cut-offs used were as follows: anti-PT (18.566 IU/mL), anti-FHA (35.711 IU/mL) and anti-PRN (11.034 IU/mL).|At Month 5 (One month after Dose 3 of co-administered vaccines)|Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.|||Participants|||Count of Participants
2535445|NCT03207750|Primary|Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 1.0 µg/mL.|Immunogenicity was assessed in terms of seroprotection rates against PRP antibodies. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-PRP antibody concentrations ≥ 1.0 µg/mL.|At Month 5 (One month after Dose 3 of co-administered vaccines)|Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.|||Participants|||Count of Participants
2535446|NCT03207750|Primary|Number of Seroprotected Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Above or Equal to Cut-off Value of 0.15 µg/mL.|Immunogenicity was assessed in terms of seroprotection rates against PRP antibodies. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-PRP antibody concentrations ≥ 0.15 µg/mL.|At Month 5 (One month after Dose 3 of co-administered vaccines)|Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.|||Participants|||Count of Participants
2535447|NCT03207750|Primary|Immunogenicity in Terms of Anti-pneumococcal Serotypes (Anti-PnPS) Antibody Concentrations.|Antibody concentrations against pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) were determined and expressed as GMCs in micrograms per milliliter (µg/mL).The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.|At Month 5 (One month after Dose 3 of co-administered vaccines)|Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.|||µg/mL||95% Confidence Interval|Geometric Mean
2535448|NCT03207750|Primary|Immunogenicity in Terms of Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations.|Antibody concentrations against PT, FHA and PRN were determined and expressed as Geometric Mean Concentrations (GMCs).The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.|At Month 5 (One month after Dose 3 of co-administered vaccines)|Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.|||IU/mL||95% Confidence Interval|Geometric Mean
2535476|NCT03207243|Secondary|Change From Baseline in Hematology Parameter: Erythrocytes|Blood samples were collected for the analysis of erythrocytes at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||10^12 cells per liter||Standard Deviation|Mean
2535449|NCT03207750|Primary|Number of Seroprotected Subjects With Anti-polio Virus Types 1, 2 and 3 Antibody Titers Above or Equal to Cut-off Value.|Immunogenicity was assessed using virus micro-neutralization test in terms of seroprotection rates against polio virus types 1, 2 and 3. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-polio virus types 1, 2 and 3 types antibody titers ≥ 8 Estimated Dose 50% (ED50).|At Month 5 (One month after Dose 3 of co-administered vaccines)|Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.|||Participants|||Count of Participants
2535450|NCT03207750|Primary|Number of Seroprotected Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above or Equal to Cut-off Value.|Immunogenicity was assessed using ChemiLuminescence ImmunoAssay (CLIA) in terms of seroprotection rates against Hepatitis B. A seroprotected subject is a subject whose antibody concentration is ≥ the level defining clinical protection. The following seroprotection thresholds were applicable:anti-HB antibody concentrations ≥ 10 milli International Units/milliliter (mIU/mL).|At Month 5 (One month after Dose 3 of co-administered vaccines)|Analysis was performed on the PPS for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.|||Participants|||Count of Participants
2535451|NCT03207750|Primary|Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Above or Equal to Cut-off Value.|Immunogenicity was assessed using Enzyme Linked Immunosorbent Assay (ELISA) in terms of seroprotection rates against diphtheria toxoid. A seroprotected subject is a subject whose antibody concentration is greater than or equal to (≥) the level defining clinical protection. The following seroprotection thresholds were applicable:anti-D antibody concentrations ≥ 0.1 International Units/milliliter (IU/mL), anti-T antibody concentrations ≥ 0.1 IU/mL.|At Month 5 (One month after Dose 3 of co-administered vaccines)|Analysis was performed on the Per protocol set (PPS) for immunogenicity which included all vaccinated subjects for whom immunogenicity data were available, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one routine infant vaccine antigen component.|||Participants|||Count of Participants
2535452|NCT03207438|Primary|Modified MADRS Response Rate|Calculated without Item 4 (reduced sleep).|Day 4 - Week 6||||Participants|||Count of Participants
2535453|NCT03207438|Primary|MADRS Response Rates|Defined as a 50% score reduction from baseline.|Day 4 - Week 6|Sample was split by the presence of baseline insomnia and treatment randomization|||Participants|||Count of Participants
2535454|NCT03207438|Primary|Modified MADRS Response Rates|50% score reduction from baseline calculated without Item 4 (reduced sleep).|1 - 6 weeks|See the number analyzed below. It decreases as study week advances due to censoring.|||Participants|||Count of Participants
2535455|NCT03207438|Primary|Number of Participants With 50 Percent Or Greater Reduction in the MADRS Score Over Time for the Quetiapine XR 150-300mg and Placebo 2 Arms/Groups Stratified by Depression Type (Melancholic vs. Nonmelancholic)|MADRS is the Montgomery-Asberg Depression Rating Scale. Total scores on this scale range from 0-60. However the response variable is binary coded (0 = No Response, 1 = Response).|1 - 6 weeks|See the number analyzed below. It decreases as the study week advances due to censoring.|||Participants|||Count of Participants
2535456|NCT03207399|Secondary|Patient Survival|1 year post transplant patient survival in recipients of HCV NAT positive donor organ|1 year post-transplant||||Participants|||Count of Participants
2535457|NCT03207399|Secondary|Patient Survival|90-day post transplant patient survival in recipients of HCV NAT positive donor organ|90 days post-transplant||||Participants|||Count of Participants
2535458|NCT03207399|Secondary|Patient Survival|1 year post transplant patient survival|1 year post-tranplant||||Participants|||Count of Participants
2535459|NCT03207399|Secondary|Patient Survival|90-day post transplant patient survival|90 days post-transplant||||Participants|||Count of Participants
2535460|NCT03207399|Secondary|Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy|Adverse events requiring temporary interruption in EPCLUSA therapy|1 year||||Participants|||Count of Participants
2535461|NCT03207399|Secondary|Change in Serum HCV RNA Levels|Serum HCV RNA levels at 12-, 24-, and 48-weeks after initiation of EPCLUSA|12, 24, and 48 weeks after initiation of EPCLUSA||||IU/mL|||Number
2535462|NCT03207399|Primary|Number of Patients Eligible for EPCLUSA Treatment|Eligibility for EPCLUSA treatment within 12 months of lung transplant|within 12 months of lung transplant||||Participants|||Count of Participants
2535463|NCT03207399|Primary|Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA|Adverse events resulting in discontinuation of EPCLUSA|1 year||||Participants|||Count of Participants
2535464|NCT03207399|Primary|Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA.|Sustained Virologic Response 12 weeks (SVR 12) in those treated with EPCLUSA.|12 weeks||||Participants|||Count of Participants
2535465|NCT03207243|Secondary|Percent Change From Baseline in Total Soluble ST2 Concentration|Blood samples were collected at given time points to measure total soluble ST2 concentration. Baseline is defined as the latest available assessment prior to first dose (Day 1). Analysis was performed using mixed model repeated measures. Percent change from Baseline is calculated as ratio to Baseline minus 1 and multiplied by 100.|Baseline and Week 4 (Pre-dose), Week 8 (Pre-dose), Week 12 (Pre-dose) and Week 16|Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Percent change||95% Confidence Interval|Number
2535509|NCT03207243|Secondary|Percentage of Participants With Clinically Significant Asthma Exacerbation or Inability to Titrate|A clinically significant asthma exacerbation is defined as one requiring oral corticosteroid and/or hospitalization. Participants with clinically significant asthma exacerbation or inability to titrate FP indicated loss of asthma control.|Up to Week 16|Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points who experienced loss of asthma control were analyzed.|||Percentage of participants|||Number
2535466|NCT03207243|Secondary|Percent Change From Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration|Blood samples were collected at given time points to measure free soluble ST2 concentration. Baseline is defined as the latest available assessment prior to first dose (Day 1). Analysis was performed using mixed model repeated measures. Percent change from Baseline is calculated as ratio to Baseline minus 1 and multiplied by 100.|Baseline and Week 4 (Pre-dose), Week 8 (Pre-dose), Week 12 (Pre-dose) and Week 16|Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Percent change||95% Confidence Interval|Number
2535467|NCT03207243|Secondary|Serum Concentrations of GSK3772847|Blood samples were collected at given time points to evaluate pharmacokinetics (PK) of GSK3772847 in participants with moderately severe asthma.|Weeks 2, 4 (Pre-dose), 8 (Pre-dose), 12 (Pre-dose and Post-dose), 16, 20, 24 and 28|PK Population consists of all randomized participants who received at least one dose of study medication, and for whom at least one pharmacokinetic sample was obtained, analyzed and was measurable. Participants with data available at specified time points were represented by n=x in the category titles.|||Micrograms per milliliter||Standard Deviation|Mean
2535468|NCT03207243|Secondary|Number of Participants With Incidence and Titres of Anti- GSK3772847 Antibodies|Blood samples were collected at given time points and the presence of anti-GSK3772847 antibodies were assessed using a a tiered approach including a screening assay, a confirmation assay and calculation of titer. Data for participants who showed positive results for confirmation assay has been presented|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and 28|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Participants|||Count of Participants
2535469|NCT03207243|Secondary|Change From Baseline in Cardiac Marker: Cardiac Troponin I|Blood samples were collected for the analysis of Troponin I at indicated time points.Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Micrograms per liter||Standard Deviation|Mean
2535470|NCT03207243|Secondary|Change From Baseline in Cardiac Marker: N-Terminal ProB-type Natriuretic Peptide|Blood samples were collected for the analysis of N-Terminal ProB-type Natriuretic Peptide at indicated time points.Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Nanograms per liter||Standard Deviation|Mean
2535471|NCT03207243|Secondary|Change From Baseline in Hematology Parameter: Erythrocytes Distribution Width (%)|Blood samples were collected for the analysis of Erythrocytes Distribution Width (%) at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Percentage (%) of Erythrocytes||Standard Deviation|Mean
2535472|NCT03207243|Secondary|Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin Concentration|Blood samples were collected for the analysis of mean corpuscular hemoglobin concentration at indicated time points.Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Grams per liter||Standard Deviation|Mean
2535473|NCT03207243|Secondary|Change From Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin|Blood samples were collected for the analysis of mean corpuscular hemoglobin at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Picogram||Standard Deviation|Mean
2535474|NCT03207243|Secondary|Change From Baseline in Hematology Parameter: Hematocrit Level|Blood samples were collected for the analysis of hematocrit at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16 and 28|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2535475|NCT03207243|Secondary|Change From Baseline in Hematology Parameter: Hemoglobin|Blood samples were collected for the analysis of hemoglobin level at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Grams per liter||Standard Deviation|Mean
2535531|NCT03205163|Secondary|PK: Half-Life for Advate and BIVV001 (High Dose Comparison)|Half-life is defined as time required for the concentration of the drug to reach half of its original value. t1/2 of Advate and BIVV001 at high dose was assessed and compared based on One-stage aPTT-based clotting assay.|For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, 240, 288, and 336 hours|Analysis was performed on PKAS.|||hours||95% Confidence Interval|Geometric Mean
2535477|NCT03207243|Secondary|Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume|Blood samples were collected for the analysis of erythrocyte mean corpuscular volume at indicated time points.Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28|Safety Population. Only those participants with data available at indicated time points were analyzed . Participants with data available at specified time points were represented by n=x in the category titles.|||Femtoliters||Standard Deviation|Mean
2535478|NCT03207243|Secondary|Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets|Blood samples were collected at given time points to assess hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, leutrophils, monocytes, and platelets . Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks1, 2, 4, 6, 8, 10, 12, 14, 16 and 28|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||10^9 cells per liter||Standard Deviation|Mean
2535479|NCT03207243|Secondary|Change From Baseline in Clinical Chemistry Parameters: Total Protein and Albumin|Blood samples were collected at given time points to assess clinical chemistry parameters including total protein and albumin levels. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 2, 4, 8, 12, 16 and 28|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Grams per liter||Standard Deviation|Mean
2535480|NCT03207243|Secondary|Change From Baseline in Clinical Chemistry Parameters: Creatinine, Total Bilirubin and Direct Bilirubin|Blood samples were collected for the analysis of clinical chemistry parameters including total bilirubin, creatinine and direct bilirubin at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 2, 4, 8, 12, 16 and 28|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Micromoles per liter||Standard Deviation|Mean
2535481|NCT03207243|Secondary|Change From Baseline in Clinical Chemistry Parameters: Glucose, Potassium, Sodium, Calcium, Phosphate, Chloride, Urea and Carbon Dioxide (CO2)|Blood samples were collected at given time points to assess clinical chemistry parameters including glucose, potassium, sodium, calcium, Phosphate, chloride, urea and CO2 levels. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 2, 4, 8, 12, 16 and 28|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Millimoles per liter||Standard Deviation|Mean
2535482|NCT03207243|Secondary|Change From Baseline in Clinical Chemistry Parameter: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Gamma- Glutamyl Transferase (GGT) and Creatine Kinase (CK)|Blood samples were collected for the analysis of clinical chemistry parameters including AST, ALT, ALP, GGT and CK at indicated time points. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 2, 4, 8, 12, 16 and 28|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||International units per liter||Standard Deviation|Mean
2535483|NCT03207243|Secondary|Change From Baseline in Supraventricular Couplets, Supraventricular Ectopics, Supraventricular Runs, Supraventricular Singles, Ventricular Couplets, Ventricular Ectopics, Ventricular Runs, Ventricular Singles|Using a Holter monitor, supraventricular couplets, supraventricular ectopics, supraventricular runs, supraventricular singles, ventricular couplets, ventricular ectopics, ventricular runs, ventricular singles were recorded at Baseline, Weeks 0, 4 and 12 through 24 hours. Participants with analyzable time of at least 16 hours were evaluated. Baseline is the value from the screening visit assessment. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 0, 4 and 12|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Events per hour||Standard Deviation|Mean
2535484|NCT03207243|Secondary|Change From Baseline in Maximum, Minimum and Average Changes in Heart Rate|Using a Holter monitor, maximum, minimum and average changes in heart rate was recorded at Baseline, Weeks 0, 4 and 12 through 24 hours. Participants with analyzable time of at least 16 hours were evaluated. Baseline is the value from the screening visit assessment. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 0, 4 and 12|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Beats per minute||Standard Deviation|Mean
2535485|NCT03207243|Secondary|Change Between Pre-dose and Post-dose of QRS Axis|Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures QRS axis. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 0, 4, 8 and 12|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Degrees||Standard Deviation|Mean
2535576|NCT03203291|Primary|Force Symmetry Ratio During Gait|0-1 symmetry ratio comparing the impulse force of the affected limb versus the unaffected limb during gait. If the unaffected limb performs equivalent to the affected limb, the ratio has a value of 1. The greater the disparity between limbs, the closer the ratio is to 0.|Baseline through day 5||||ratio||Standard Deviation|Mean
2535486|NCT03207243|Secondary|Change Between Pre-dose and Post-dose of Heart Rate|Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures heart rate. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 0, 4, 8 and 12|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Beats per minute||Standard Deviation|Mean
2535487|NCT03207243|Secondary|Change Between Pre-dose and Post-dose of PR Interval, QRS Duration, Uncorrected QT Interval, QTcF Interval and RR Interval|Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures PR interval, QRS duration, uncorrected QT interval, QTcF interval and RR interval. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 0, 4, 8 and 12|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||milliseconds||Standard Deviation|Mean
2535488|NCT03207243|Secondary|Change From Baseline in QRS Axis|Triplicate 12-lead ECGs were recorded with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures QRS axis. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Week 4 (Pre and Post dose), Week 8 (Pre and Post dose), Week 12 (Pre and Post dose) and Week 16|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Degrees||Standard Deviation|Mean
2535489|NCT03207243|Secondary|Change From Baseline in ECG Heart Rate|Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures heart rate. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Week 0 (Post-dose), Week 4 (Pre and Post dose), Week 8 (Pre and Post dose), Week 12 (Pre and Post dose) and Week 16|Safety Population. Participants with data available at specified time points were represented by n=x in the category titles.|||Beats per minute||Standard Deviation|Mean
2535490|NCT03207243|Secondary|Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Corrected Interval-Fredericia [QTcF] Interval and RR Interval|Triplicate 12-lead ECGs were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measures PR interval, QRS duration, uncorrected QT interval, QTcF interval and RR interval. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Week 0 (Post-dose), Week 4 (Pre and Post dose), Week 8 (Pre and Post dose), Week 12 (Pre and Post dose) and Week 16|Safety Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||milliseconds||Standard Deviation|Mean
2535491|NCT03207243|Secondary|Change From Baseline Between Post-dose and Pre-dose in Pulse Rate|Pulse rate was measured pre-dose and post-dose in semi-supine position after 5 minutes rest. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 0, 4, 8 and 12|Safety Population. Participants with data available at specified time points were represented by n=x in the category titles.|||Beats per minute||Standard Deviation|Mean
2535492|NCT03207243|Secondary|Change From Baseline Between Post-dose and Pre-dose in DBP and SBP|DBP and SBP was measured pre-dose and post-dose in semi-supine position after 5 minutes rest. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 0, 4, 8 and 12|Safety Population. Participants with data available at specified time points were represented by n=x in the category titles.|||mmHg||Standard Deviation|Mean
2535493|NCT03207243|Secondary|Change From Baseline in Pulse Rate (PR)|Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data for change from Baseline for post dose values have been presented.|Baseline and Week 0 (Post-dose), Week1, Week 2, Week 4 (Pre and Post dose), Week 6, Week 8 (Pre and Post dose), Week 10, Week 12 (Pre and Post dose), Week 14, Week 16, Week 20, Week 24 and Week 28|Safety Population. Participants with data available at specified time points were represented by n=x in the category titles.|||Beats per minute||Standard Deviation|Mean
2535494|NCT03207243|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|DBP and SBP were measured in semi-supine position after 5 minutes rest. Baseline is defined as the most recent recorded value before dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data for change from Baseline for post dose values have been presented.|Baseline and Week 0 (Post-dose), Week1, Week 2, Week 4 (Pre and Post dose), Week 6, Week 8 (Pre and Post dose), Week 10, Week 12 (Pre and Post dose), Week 14, Week 16, Week 20, Week 24 and Week 28|Safety Population. Participants with data available at specified time points were represented by n=x in the category titles.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2535508|NCT03207243|Secondary|Number of Participants Experiencing Asthma Related Hospitalization During the Study Period|Hospitalization is defined as an inpatient stay or least an overnight stay at the hospital or emergency ward for observation or other equivalent facility. Data has been presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.|Up to Week 16|Modified Intent-to-Treat (mITT) population consisted of all randomized participants who took at least 1 dose of study treatment and were analyzed according to the treatment they received >=50% of the time.|||Participants|||Count of Participants
2535495|NCT03207243|Secondary|Number of Participants Reporting Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs)|A non-SAE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment were categorized as SAE.|Up to Week 16|Safety Population consists of all randomized participants who took at least 1 dose of study treatment.|||Participants|||Count of Participants
2535496|NCT03207243|Secondary|Percent Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)|FeNO was assessed as a measure of airway inflammation using a handheld electronic device. The measurements recorded were according to standardized procedures by the American Thoracic Society and the European Respiratory Society Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide. FeNO measurements were obtained prior to FEV1 assessments. Participants did not use their rescue medication for at least 6 hours before each FeNO assessment, unless essential for clinical need. Baseline is defined as the latest available assessment prior to first dose (Day 1). Percent change from Baseline is calculated as ratio to Baseline minus one and multiplied by 100. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.|Baseline and Weeks 1, 2, 4, 6, 8, 10, 12, 14 and 16|Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Percent Change||Full Range|Median
2535497|NCT03207243|Secondary|Change From Baseline in Percent Night-time Awakenings Due to Asthma Symptoms Requiring Rescue Medication Use|Participant captured night-time awakenings (yes/no) and use of rescue medication during these awakenings (yes/no) was recorded in e-Diary each morning. Percentage of night-time awakenings is calculated by number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data available*100. Baseline was calculated over the last 7 days of run-in period prior to Visit 2 (Week 0). Participants having at least 4 full days of data in the last 7 days of run-in were included. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Night-time awakenings due to asthma symptoms requiring rescue medication was calculated for each participant during the four weekly periods (Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16). Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.|Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16|Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Percentage of nights with awakenings||Standard Deviation|Mean
2535498|NCT03207243|Secondary|Change From Baseline in Mean Daily Rescue Medication Use (Albuterol/Salbutamol)|The mean number of inhalation of rescue medication (albuterol/salbutamol) used to relieve symptoms immediately during the day and night was recorded in eDiary from Baseline until Week 16. Baseline was calculated over the last 7 days of run-in period prior to Visit 2 (Week 0). Participants with at least 4 full days of data in the last 7 days of run-in were included. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. The mean rescue medication use was calculated for each participant during the four weekly periods (Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16). Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.|Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16|Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Inhalations per day||Standard Deviation|Mean
2535499|NCT03207243|Secondary|Change From Baseline in Mean Daytime Asthma Symptom Score Over Each Four Weeks of the 16 Week Treatment Period|Asthma symptoms experienced by participants during the day was recorded in e-Diary every evening before going to bed in form of scores on a 5-point rating scale. Scores ranged from 0=no daytime asthma symptoms to 4=very severe daytime asthma symptoms. Baseline was calculated over the last 7 days of run-in period prior to Visit 2 (Week 0). Participants with at least 4 full days of data in the last 7 days of run-in were included. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. The mean asthma symptom score was calculated for each participant during the four weekly periods (Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16). Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.|Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16|Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Scores on a scale||Standard Deviation|Mean
2535500|NCT03207243|Secondary|Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) and Mean Evening PEF|PEF is maximum speed of expiration measured, using spirometer. The device was distributed to participants at Visit 1, to measure PEF twice-daily (morning upon waking & in the evening just before going to bed). Participants were encouraged to perform morning & evening PEF measurements before the use of any long-acting beta-agonists (LABAs) or rescue medication. Highest of 3 values were recorded in eDairy.Baseline was calculated over the last 7 days of run-in period prior to Visit 2 (Week 0). Participants with at least 4 full days of data in the last 7 days of run-in were included. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Mean PEF was calculated for each participant during the four weekly periods (Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16).Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment|Baseline and Weeks 1-4; Weeks 5-8, Weeks 9-12 and Weeks 13-16.|Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Liters/minute||Standard Deviation|Mean
2535501|NCT03207243|Secondary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)|Pre-bronchodilator FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline is defined as the latest available assessment prior to first dose (Day 1) and change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.|Baseline and Weeks 2, 4, 6, 8, 10, 12, 14 and 16|Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Liters||Standard Deviation|Mean
2535502|NCT03207243|Secondary|Percentage of Participants With at Least a 4 Units Improvement From Baseline of St. George's Respiratory Questionnaire (SGRQ)|SGRQ is a disease-specific questionnaire designed to measure impact of respiratory disease and its treatment on HRQoL of participants with COPD. It contains 14 questions with a total of 40 items grouped into domains (Symptoms, Activity and Impacts). SGRQ total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. It ranges from 0 to 100, higher score indicates poor HRQoL. Baseline is defined as the latest available assessment prior to first dose (Day 1). A responder is defined as a change from Baseline of <= -4 at the given time point. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.|Baseline and Weeks 4, 8, 12 and 16|Modified Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Percentage of participants|||Number
2535503|NCT03207243|Secondary|Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score|SGRQ is a disease-specific questionnaire designed to measure impact of respiratory disease and its treatment on Health-related quality of life (HRQoL) of participants with Chronic Obstructive Pulmonary Disease (COPD). It contains 14 questions with a total of 40 items grouped into domains (Symptoms, Activity and Impacts). SGRQ total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. It ranges from 0 to 100, higher score indicates poor HRQoL. Baseline is defined as the latest available assessment prior to first dose (Day 1). Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.|Baseline and Weeks 4, 8, 12 and 16|Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Scores on a scale||Standard Deviation|Mean
2535504|NCT03207243|Secondary|Percentage of Participants With <=-0.5 Point ACQ-5 Score Decrease From Baseline (Responder)|ACQ-5 is a five-item, self-completed questionnaire, which measures asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath & wheeze) enquire about the frequency &/or severity of symptoms over the previous week. The response options range from zero (no impairment/limitation) to six (total impairment/limitation) scale. ACQ-5 score ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicate lower asthma control. Baseline is the latest available assessment prior to first dose (Day 1). Change from Baseline was calculated by subtracting Baseline value from the specified time point value. A responder is defined as participants with change from Baseline of <= -0.5 point at given time point. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 16|Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Percentage of participants|||Number
2535505|NCT03207243|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ-5) Total Score|ACQ-5 is a five-item, self-completed questionnaire, which measures asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath & wheeze) enquire about the frequency &/or severity of symptoms over the previous week. The response options range from zero (no impairment/limitation) to six (total impairment/limitation) scale. ACQ-5 score ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicate lower asthma control. Baseline is the latest available assessment prior to first dose (Day 1). Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 16|Modified Intent-to-Treat Population. Only those participants with data available at indicated time points were analyzed. Participants with data available at specified time points were represented by n=x in the category titles.|||Scores on a scale||Standard Deviation|Mean
2535506|NCT03207243|Secondary|Number of Hospitalizations or Emergency Room Visits Per Participants|The number of hospitalization or emergency room visit made by per participant due to loss of asthma control have been presented in category titles. Data has been presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.|Up to Week 16|Modified Intent-to-Treat Population.|||Participants|||Count of Participants
2535507|NCT03207243|Secondary|Rate Per 1000 Person-years of Participants With Hospitalization|An event is defined as an on-treatment asthma-related hospitalization or emergency room visit and participants can contribute to more than one event. Rate is calculated as number of events * 1000 divided by (number of participants in treatment group * mean treatment exposure in years). Data has been presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment.|Up to Week 16|Modified Intent-to-Treat Population.|||Events per person-year|||Number
2536689|NCT03159299|Secondary|Change in Diabetes Self-management From Baseline|Measured by the Summary of Diabetes Self-Care Activities questionnaire, a multi-dimensional12-item scale with items on general diet, specific diet, monitoring blood glucose, foot care, and smoking|3 months|||||||
2535510|NCT03207243|Secondary|Time to Loss of Asthma Control|Time to loss of asthma control was analyzed using Kaplan-Meier analysis. In this analysis, participants were either be counted as an event or they were censored. An event is defined as participants who experience loss of asthma control during the study. Censoring is defined as participants who discontinued investigational product for reasons other than loss of asthma control. The analysis shown is for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. Participants who didn't experience loss of asthma control were also censored at day 113.|Up to Week 16|Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points who experienced loss of asthma control were analyzed.|||Days||Inter-Quartile Range|Median
2535511|NCT03207243|Secondary|Percentage of Participants With Loss of Asthma Control Over Weeks 0-6|Loss of asthma control is defined as: ACQ-5 score increase from Baseline >=0.5 point or pre-bronchodilator FEV1 decrease from Baseline >7.5 % or inability to titrate inhaled corticosteroid or a clinically significant asthma exacerbation (requiring oral OCS and/or hospitalization). The analysis shown is for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. Baseline is defined as Day1. Percentage of participants experiencing loss of asthma control up to Week 6 has been presented.|Up to Week 6|Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points were analyzed.|||Percentage of participants|||Number
2535512|NCT03207243|Secondary|Percentage of Participants With Clinically Significant Asthma Exacerbation|A clinically significant asthma exacerbation is defined as one requiring oral corticosteroid and/or hospitalization.|Up to Week 16|Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points who experienced loss of asthma control were analyzed.|||Percentage of participants|||Number
2535513|NCT03207243|Secondary|Percentage of Participants With Inability to Titrate Inhaled Corticosteroids (ICS)|Corticosteroid titration allows overall clinical evaluation of the participant's asthma status taking into account both lung function and symptom control. Inability to titrate inhaled corticosteroids indicates loss of asthma control.|Up to Week 16|Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points who experienced loss of asthma control were analyzed.|||Percentage of participants|||Number
2535514|NCT03207243|Secondary|Percentage of Participants Who Have Pre-bronchodilator FEV1 Decrease From Baseline >7.5 %|Pulmonary function is measured by FEV1. FEV1 is the amount of air expired in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry. Baseline is defined as the latest available pre-dose assessment (Day 1). Decrease from Baseline >7.5 % in score suggests worsening of condition.|Baseline and up to Week 16|Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points who experienced loss of asthma control were analyzed.|||Percentage of participants|||Number
2535515|NCT03207243|Secondary|Percentage of Participants With >=0.5 Point Asthma Control Questionnaire (ACQ-5) Score Increase From Baseline|The ACQ-5 is a five-item, self-completed questionnaire, which measures asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. ACQ-5 score ranges from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicate lower asthma control. Baseline is the latest available assessment prior to first dose (Day 1). Change from Baseline was calculated by subtracting Baseline value from the specified time point value. A change of >=0.5 in score suggests a clinically important change in score. Data is presented for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment|Baseline and up to Week 16|Modified Intent-to-Treat (Loss of Control) Population. Only those participants with data available at indicated time points who experienced loss of asthma control were analyzed.|||Percentage of participants|||Number
2535516|NCT03207243|Primary|Percentage of Participants With Loss of Asthma Control Over Weeks 0-16|Loss of asthma control is defined as: Asthma Control Questionnaire (ACQ-5) score increase from Baseline >=0.5 point or pre-bronchodilator forced expiratory volume in 1 second (FEV1) decrease from baseline >7.5 % or inability to titrate inhaled corticosteroid or a clinically significant asthma exacerbation (requiring oral corticosteroid [OCS] and/or hospitalization). The analysis shown is for primary estimand which includes all data collected, except for data collected after the date of loss of asthma control or early withdrawal from study treatment. Baseline is defined as Day1. Percentage of participants experiencing loss of asthma control up to Week 16 has been presented. Modified Intent-to-Treat (Loss of Control) (mITT_LoC) population consisted of all randomized participants who took at least 1 dose of study treatment and if participants experienced loss of asthma control, they were analyzed according to actual treatment at time of loss of control.|Up to Week 16|Modified Intent-to-Treat (Loss of Control) (mITT_LoC) Population. Only those participants with data available at indicated time points were analyzed.|||Percentage of participants|||Number
2535517|NCT03206216|Secondary|"Correlation Between the Adelta:C Pain Threshold Ratio and Pain Development"|A Spearman correlation coefficient will be obtained for the A-delta:C pain threshold ratio as measured at 9 weeks (dependent variable) assessed against the presence or absence of pain (binary pain value) at 21 weeks (independent variable). The Spearman correlation coefficient will be obtained by logistic regression analysis.|Up to 24 weeks|The only participant withdrew before the 21-week assessment. No outcome assessment is possible.||||||
2535518|NCT03206216|Primary|A-delta:C Pain Threshold Ratio|"The A-delta:C pain threshold ratio is calculated based on the A-delta-fiber and C-fiber pain thresholds. The outcome was the difference in the A-delta:C pain ratio between the 9-week assessment and the 21-week assessment, to be reported as the mean with standard deviation for participant with painful CIPN (Group A) or painless CIPN (Group B)."|Up to 24 weeks|The only participant withdrew before the 21-week assessment. No outcome assessment is possible.||||||
2535546|NCT03203564|Secondary|Plasma PK Characteristics: Tmax|Pharmacokinetic parameters were calculated for test item MTHF, and for the following metabolites: 5-Formyl-THF, 5-Methyl-THF, and THF, if data permitted|Pre-dose at -15 min and post-dose at following timepoints: 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h.|All samples analysed from the subjects given placebo were below Lower Limit of Quantification.|||hour||Standard Deviation|Mean
2535519|NCT03205163|Secondary|PK: Time to 1% Above Baseline for FVIII Activity for Advate and BIVV001 (High Dose Comparison)|Time to 1% activity is the time required from the start of dosing for the FVIII activity to reach 1 IU/dL (1%) above their baseline levels. Time to 1% above baseline for FVIII Activity of Advate and BIVV001 at high dose was assessed and compared based on One-stage aPTT-based clotting assay.|For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, 240, 288, and 336 hours|Analysis was performed on PKAS.|||hours||95% Confidence Interval|Geometric Mean
2535520|NCT03205163|Secondary|PK: Time to 1% Above Baseline for FVIII Activity for Advate and BIVV001 (Low Dose Comparison)|Time to 1% activity is the time required from the start of dosing for the FVIII activity to reach 1 IU/dL (1%) above their baseline levels. Time to 1% above baseline for FVIII Activity of Advate and BIVV001 at low dose was assessed and compared based on One-stage aPTT-based clotting assay.|For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, and 240 hours|Analysis was performed on PKAS.|||hours||95% Confidence Interval|Geometric Mean
2535521|NCT03205163|Secondary|PK: Incremental Recovery (IR) for Advate and BIVV001 (High Dose Comparison)|Incremental Recovery is defined as the increase in the circulating FVIII activity level for one unit (IU) of the FVIII product per kilogram body weight. IR of Advate and BIVV001 at high dose was assessed and compared based on One-stage aPTT-based clotting assay.|For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, 240, 288, and 336 hours|Analysis was performed on PKAS.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
2535522|NCT03205163|Secondary|PK: Incremental Recovery (IR) for Advate and BIVV001 (Low Dose Comparison)|Incremental Recovery is defined as the increase in the circulating FVIII activity level for one unit (IU) of the FVIII product per kilogram body weight. IR of Advate and BIVV001 at low dose was assessed and compared based on One-stage aPTT-based clotting assay.|For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, and 240 hours|Analysis was performed on PKAS.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
2535523|NCT03205163|Secondary|PK: Mean Residence Time (MRT) for Advate and BIVV001 (High Dose Comparison)|The average time at which the number of absorbed molecules reside in the body, after single-dose administration. MRT of Advate and BIVV001 at high dose was assessed and compared based on One-stage aPTT-based clotting assay.|For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, 240, 288, and 336 hours|Analysis was performed on PKAS.|||hours||95% Confidence Interval|Geometric Mean
2535524|NCT03205163|Secondary|PK: Mean Residence Time (MRT) for Advate and BIVV001 (Low Dose Comparison)|The average time at which the number of absorbed molecules reside in the body, after single-dose administration. MRT of Advate and BIVV001 at low dose was assessed and compared based on One-stage aPTT-based clotting assay.|For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, and 240 hours|Analysis was performed on PKAS.|||hours||95% Confidence Interval|Geometric Mean
2535525|NCT03205163|Secondary|PK: Area Under the Concentration Time Curve From Time 0 to Infinity (AUCinfinity) for Advate and BIVV001 (High Dose Comparison)|AUCinfinity of Advate and BIVV001 at high dose was assessed and compared based on One-stage aPTT-based clotting assay.|For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, 240, 288, and 336 hours|Analysis was performed on PKAS.|||hour*international unit/deciliter||95% Confidence Interval|Geometric Mean
2535526|NCT03205163|Secondary|PK: Area Under the Concentration Time Curve (AUC) From Time 0 to Infinity (AUCinfinity) for Advate and BIVV001 (Low Dose Comparison)|AUCinfinity of Advate and BIVV001 at low dose was assessed and compared based on One-stage aPTT-based clotting assay.|For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, and 240 hours|Analysis was performed on PKAS.|||hour*international unit/deciliter||95% Confidence Interval|Geometric Mean
2535527|NCT03205163|Secondary|PK: Volume of Distribution at Steady State (Vss) for Advate and BIVV001 (High Dose Comparison)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss of Advate and BIVV001 at high dose was assessed and compared based on One-stage aPTT-based clotting assay.|For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, 240, 288, and 336 hours|Analysis was performed on PKAS.|||mL/kg||95% Confidence Interval|Geometric Mean
2535528|NCT03205163|Secondary|PK: Volume of Distribution at Steady State (Vss) for Advate and BIVV001 (Low Dose Comparison)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss of Advate and BIVV001 at low dose was assessed and compared based on One-stage aPTT-based clotting assay.|For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, and 240 hours|Analysis was performed on PKAS.|||milliliter/kilogram (mL/kg)||95% Confidence Interval|Geometric Mean
2535529|NCT03205163|Secondary|PK: Total Body Clearance (CL) for Advate and BIVV001 (High Dose Comparison)|Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL of Advate and BIVV001 at high dose was assessed and compared based on One-stage aPTT-based clotting assay.|For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, 240, 288, and 336 hours|Analysis was performed on PKAS.|||mL/hr/kg||95% Confidence Interval|Geometric Mean
2535530|NCT03205163|Secondary|PK: Total Body Clearance (CL) for Advate and BIVV001 (Low Dose Comparison)|Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body. CL of Advate and BIVV001 at low dose was assessed and compared based on One-stage aPTT-based clotting assay.|For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, and 240 hours|Analysis was performed on PKAS.|||milliliter/hour/kilogram (mL/hr/kg)||95% Confidence Interval|Geometric Mean
2535532|NCT03205163|Secondary|PK: Half-Life (t1/2) for Advate and BIVV001 (Low Dose Comparison)|Half-life is defined as time required for the concentration of the drug to reach half of its original value. t1/2 of Advate and BIVV001 at low dose was assessed and compared based on One-stage aPTT-based clotting assay.|For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, and 240 hours|Analysis was performed on PKAS.|||hours||95% Confidence Interval|Geometric Mean
2535533|NCT03205163|Secondary|PK: Maximum Observed Plasma Concentration (Cmax) for Advate and BIVV001 (High Dose Comparison)|Cmax of Advate and BIVV001 at high dose was assessed and compared based on One-stage aPTT-based clotting assay.|For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, 240, 288, and 336 hours|Analysis was performed on PKAS.|||IU/dL||95% Confidence Interval|Geometric Mean
2535534|NCT03205163|Secondary|Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) for Advate and BIVV001 (Low Dose Comparison)|Cmax of Advate and BIVV001 at low dose was assessed and compared based on One-stage activated partial thromboplastin time (aPTT)-based clotting assay.|For Advate: Pre-dose and Post dose at 0.5, 1, 6, 24, 48, and 72 hours; For BIVV001: Pre-dose and Post dose at 0.17, 0.5, 1, 3, 6, 9, 24, 48, 72, 96, 120, 168, and 240 hours|Analysis was performed on pharmacokinetic analysis set (PKAS) which included participants who had adequate blood sample collections (following Advate or BIVV001 administration), to assess key PK parameters, as determined by the PK scientist.|||International unit/deciliter (IU/dL)||95% Confidence Interval|Geometric Mean
2535535|NCT03205163|Primary|Percentage of Participants With Confirmed Inhibitor Development as Measured by the Nijmegen-Modified Bethesda Assay|Development of an inhibitor was defined as a neutralizing antibody value of greater than or equal to (>=) 0.6 Bethesda units per milliliter (BU/mL) identified and confirmed by a second test on an independent sample, collected within 2 to 4 weeks of the first positive sample, with both tests performed by the central laboratory using Nijmegen-modified Bethesda assay.|Up to 28 days after BIVV001 administration|Analysis was performed on safety analysis set.|||percentage of participants|||Number
2535536|NCT03205163|Primary|Number of Participants With Clinically Significant Abnormalities in Laboratory Tests During BIVV001 Treatment Period|Number of participants with clinically significant abnormalities (including hematology, clinical chemistry, urinalysis, and coagulation and thrombosis markers) was reported.|Up to 28 days after BIVV001 administration|Analysis was performed on safety analysis set.|||Participants|||Count of Participants
2535537|NCT03205163|Primary|Number of Participants With Clinically Significant Abnormalities in Laboratory Tests During Advate Treatment Period|Number of Participants with Clinically Significant Abnormalities in Laboratory tests (including hematology, clinical chemistry, urinalysis, and coagulation and thrombosis markers) was reported.|Up to Day 3 for Advate 25 IU/kg; up to Day 4 for Advate 65 IU/kg|Analysis was performed on safety analysis set.|||Participants|||Count of Participants
2535538|NCT03205163|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) During BIVV001 Treatment Period|AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAE is defined as any AE that begins on or after the study treatment (BIVV001) and within 28 days after BIVV001 administration. SAE was defined as any AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital/anomaly/birth defect, or any other medically important event.|Up to 28 days after BIVV001 administration|Analysis was performed on safety analysis set which included all participants who received at least 1 dose of BIVV001.|||Participants|||Count of Participants
2535539|NCT03205163|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) During Advate Treatment Period|AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAE is defined as any AE that begins on or after the single dose of Advate but before the single dose of BIVV001. Serious AE (SAE) was defined as any AE resulting in death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, or a congenital/anomaly/birth defect, or any other medically important event.|Up to Day 3 for Advate 25 IU/kg; up to Day 4 for Advate 65 IU/kg|Analysis was performed on safety analysis set which included all participants who received at least 1 dose of Advate.|||Participants|||Count of Participants
2535540|NCT03204643|Secondary|Utilization of Healthcare Services Post-discharge From Emergency Department|Number of Emergency Department, inpatient, observation encounters|45 days||||Participants|||Count of Participants
2535541|NCT03204643|Secondary|Patient-centric (Protocol Defined) Readmission Rate|readmission within 30 days to any facility which Carolinas Healthcare System have access to the data|30 days||||Participants|||Count of Participants
2535542|NCT03204643|Secondary|Quality, Comfort, and Care (QCC) Defined Readmission Rate|readmission within 30 days to the same facility|30 days||||Participants|||Count of Participants
2535543|NCT03204643|Primary|Emergency Department to Inpatient Conversion Rate|admission from the Emergency Department with behavioral health consult completed, to an inpatient or observation setting.|5 days|The number of patients that were admitted|||participants|||Number
2535544|NCT03203564|Secondary|Number of Subjects With AEs|An overall summary of subjects with AEs occurring after first administration of IMP (TEAE), number of related TEAEs and number of withdrawals due to TEAEs are presented by treatment|From start of IMP administration to follow-up visit|FAS|||Subjects|||Number
2535545|NCT03203564|Secondary|Plasma PK Characteristics: Cmax/Dose for Metabolite 5-Formyl-THF|Pharmacokinetic parameters were calculated for test item MTHF, and for the following metabolites: 5-Formyl-THF, 5-Methyl-THF, and THF, if data permitted. Only the metabolite 5-Formyl-THF has values above LLOQ and are presented below.|Pre-dose at -15 min and post-dose at following timepoints: 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h|All samples analysed from the subjects given placebo were below Lower Limit of Quantification.|||ng/mL/mg||Standard Deviation|Mean
2535574|NCT03203291|Secondary|Symmetry Ratio of Stride Length|0-1 symmetry ratio comparing the stride length of the affected limb versus the unaffected limb during gait. If the unaffected limb performs equivalent to the affected limb, the ratio has a value of 1. The greater the disparity between limbs, the closer the ratio is to 0.|Baseline through week 3||||ratio||Standard Deviation|Mean
2535547|NCT03203564|Secondary|Plasma PK Characteristics: Cmax|Pharmacokinetic parameters were calculated for test item MTHF, and for the following metabolites: 5-Formyl-THF, 5-Methyl-THF, and THF, if data permitted|Pre-dose at -15 min and post-dose at following timepoints: 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h.|All samples analysed from the subjects given placebo were below Lower Limit of Quantification.|||ng/mL||Standard Deviation|Mean
2535548|NCT03203564|Secondary|Plasma PK Characteristics: Vss|Pharmacokinetic parameters were calculated for test item MTHF, and for the following metabolites: 5-Formyl-THF, 5-Methyl-THF, and THF, if data permitted|Pre-dose at -15 min and post-dose at following timepoints: 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h|All samples analysed from the subjects given placebo were below Lower Limit of Quantification.|||litre||Standard Deviation|Mean
2535549|NCT03203564|Secondary|Plasma PK Characteristics: CL|Pharmacokinetic parameters were calculated for test item MTHF, and for the following metabolites: 5-Formyl-THF, 5-Methyl-THF, and THF, if data permitted.|Pre-dose at -15 min and post-dose at following timepoints: 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h.|All samples analysed from the subjects given placebo were below Lower Limit of Quantification.|||L/h||Standard Deviation|Mean
2535550|NCT03203564|Secondary|Plasma PK Characteristics: t1/2|Pharmacokinetic parameters were calculated for test item MTHF, and for the following metabolites: 5-Formyl-THF, 5-Methyl-THF, and THF, if data permitted:|Pre-dose at -15 min and post-dose at following timepoints: 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h.|All samples analysed from the subjects given placebo were below Lower Limit of Quantification|||hour||Standard Deviation|Mean
2535551|NCT03203564|Secondary|Plasma PK Characteristics: Timepoint for Last Measured Plasma Concentration (Tlast)|Pharmacokinetic parameters were calculated for test item MTHF, and for the following metabolites: 5-Formyl-THF, 5-Methyl-THF, and THF, if data permitted.|Pre-dose at -15 min and post-dose at following timepoints: 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h.|All samples analysed from the subjects given placebo were below Lower Limit of Quantification (LLOQ).|||hour||Standard Deviation|Mean
2535552|NCT03203564|Secondary|Plasma PK Characteristics: AUClast/Dose|Pharmacokinetic parameters were calculated for test item MTHF, and for the following metabolites: 5-Formyl-THF, 5-Methyl-THF, and THF, if data permitted.|Pre-dose at -15 min and post-dose at following timepoints: 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h.|All samples analysed from the subjects given placebo were below Lower Limit of Quantification.|||(h*ng/mL)/mg||Standard Deviation|Mean
2535553|NCT03203564|Secondary|Plasma PK Characteristics: AUClast|Pharmacokinetic parameters were calculated for test item MTHF, and for the following metabolites: 5-Formyl-THF, 5-Methyl-THF, and THF, if data permitted|Pre-dose at -15 min and post-dose at following timepoints: 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h.|All samples analysed from the subjects given placebo were below Lower Limit of Quantification.|||h*ng/mL||Standard Deviation|Mean
2535554|NCT03203564|Secondary|Plasma PK Characteristics: C5min|Measured concentration at 5 min post dose (C5min) of MTHF and 5-Formyl-THF|Pre-dose at -15 min and post-dose at following timepoints: 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h|All samples analysed from the subjects given placebo were below Lower Limit of Quantification.|||ng/mL||Standard Deviation|Mean
2535555|NCT03203564|Secondary|Plasma PK Characteristics: C0|The mean back-extrapolated concentration at time 0 h (C0) was calculated for MTHF|Pre-dose at -15 min and post-dose at following timepoints: 5 min, 15 min, 30 min, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h. pre-dose to 24 h post-dose|All samples analysed from the subjects given placebo were below Lower Limit of Quantification.|||ng/mL||Standard Deviation|Mean
2535556|NCT03203564|Secondary|Frequency, Seriousness and Intensity of AEs|An overall summary of AEs occurring after first administration of IMP (TEAE) is presented by treatment|From start of IMP administration to follow-up visit|FAS|||Adverse events|||Number
2535557|NCT03203564|Secondary|Safety Laboratory Measurements|"The following safety laboratory parameters were assessed:~Clinical Chemistry: Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Albumin, Aspartate aminotransferase (AST), Bilirubin (total and conjugated), Calcium, Chloride, Creatinine, Magnesium, Phosphorous, Potassium, Sodium, Urea nitrogen, Uric acid. Haematology: Haematocrit, Haemoglobin (Hb), Platelet count, Red blood cell (RBC) count, White blood cell (WBC) count with differential count. Urinalysis (dip stick):Glucose, Erythrocytes, Nitrite, Protein, Specific gravity, pH."|Pre-dose at screening (visit 1) and -2h (visit 2). Post-dose at following timepoints: 24 h (visit 2) and at follow-up (visit 3)||||Clinically relevant changes|||Number
2535558|NCT03203564|Secondary|Vital Signs: Pulse|"Systolic and diastolic BP and pulse were measured in supine position after 10 min of rest.~There were no clinically relevant mean changes over time or any individual changes assessed as clinically significant with regards to any of the vital signs parameters."|Predose at following timepoints: At screening (visit 1) and at -15 min (visit 2). Postdose at following timepoints: 3h, 5h, 8 h and 24h (visit 2) and at visit 3 (follow-up visit).||||bpm||Standard Deviation|Mean
2535559|NCT03203564|Secondary|Diastolic Blood Pressure|"Systolic and diastolic BP and pulse were measured in supine position after 10 min of rest.~There were no clinically relevant mean changes over time or any individual changes assessed as clinically significant with regards to any of the vital signs parameters."|Predose at following timepoints: At screening (visit 1) and at -15 min (visit 2). Postdose at following timepoints: 3h, 5h, 8 h and 24h (visit 2) and at visit 3 (follow-up visit).||||mmHg||Standard Deviation|Mean
2535560|NCT03203564|Secondary|Systolic Blood Pressure|Systolic and diastolic BP and pulse were measured in supine position after 10 min of rest.|Predose at following timepoints: At screening (visit 1) and at -15 min (visit 2). Postdose at following timepoints: 3h, 5h, 8 h and 24h (visit 2) and at visit 3 (follow-up visit).||||mmHg||Standard Deviation|Mean
2535561|NCT03203564|Secondary|Physical Examination|"A complete physical examination included assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities.~Physical examination findings were categorized as Normal, Abnormal non-clinical significant (NCS), and Abnormal clinical significant (CS)."|At visit 1 (screening) and follow-up||||Participants|||Count of Participants
2535575|NCT03203291|Primary|Stance Time Symmetry Ratio|"0-1 symmetry ratio of the percentage of time spent in the stance phase of a gait cycle. If the unaffected limb performs equivalent to the affected limb, the ratio will have a value of 1. The greater the disparity the closer the ratio is to 0.~Stance time symmetry = Time in stance phase of gait cycle of Affected/Unaffected limb."|Baseline through week 3||||ratio||Standard Deviation|Mean
2535562|NCT03203564|Secondary|Categorical Analysis for T Wave Morphology|Categorical T-wave morphology analysis and measurement of PR and QRS intervals were fully performed manually in three of the 10 ECG replicates at each time point. Final quality control and diagnostic interpretations were performed by the study cardiologist. When the results for each time point were compiled in the final data set, the comparison was made between ECG parameters from the three manually reviewed ECGs versus the 10 ECG replicates for quality control purposes. No treatment emergent T wave morphology changes were observed. In addition to the T-wave categorical analysis, the presence of abnormal U-waves was noted.|Pre-dose at following timepoints -2 h, -45 min, -30 min, -15 min. Then at following timepoints; 0, 5 min, 15 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h post-dose.||||Participants|||Count of Participants
2535563|NCT03203564|Secondary|Categorical Outliers for HR, PR Interval, QRS Interval|Categorical Analysis of outliers for HR, PR, and QRS intervals|Pre-dose at following timepoints -2 h, -45 min, -30 min, -15 min. Then at following timepoints; 0, 5 min, 15 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h post-dose.||||Participants|||Count of Participants
2535564|NCT03203564|Secondary|Number of Participants With Categorical QTcF Outliers|QTcF outliers per absolute category across treatment groups and QTcF outliers per change-from-baseline category (ΔQTcF)|Pre-dose at following timepoints -2 h, -45 min, -30 min, -15 min. Then at following timepoints; 0, 5 min, 15 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h post-dose.||||Participants|||Count of Participants
2535565|NCT03203564|Secondary|Change-from-baseline QRS (ΔQRS)|The analysis was based on the change-from-baseline post-dosing values. The same (by-time point analysis) model was used as described for QTcF. For all ECG parameters, baseline is defined as the average of the measured ECG intervals from the three pre-dose time points (45, 30, and 15 min predose) on Day 1.|Pre-dose at following timepoints -2 h, -45 min, -30 min, -15 min. Then at following timepoints; 0, 5 min, 15 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h post-dose.|QT/QTc population|||msec||Standard Error|Least Squares Mean
2535566|NCT03203564|Secondary|Change-from-baseline PR (ΔPR)|The analysis was based on the change-from-baseline post-dosing values. The same (by-time point analysis) model was used as described for QTcF. For all ECG parameters, baseline is defined as the average of the measured ECG intervals from the three pre-dose time points (45, 30, and 15 min predose) on Day 1.|Pre-dose at following timepoints -2 h, -45 min, -30 min, -15 min. Then at following timepoints; 0, 5 min, 15 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h post-dose.|QT/QTc population|||msec||Standard Error|Least Squares Mean
2535567|NCT03203564|Secondary|Change-from-baseline Heart Rate (ΔHR)|The analysis was based on the change-from-baseline post-dosing values. The same (by-time point analysis) model was used as described for QTcF. For all ECG parameters, baseline is defined as the average of the measured ECG intervals from the three pre-dose time points (45, 30, and 15 min predose) on Day 1.|Pre-dose at following timepoints -2 h, -45 min, -30 min, -15 min. Then at following timepoints; 0, 5 min, 15 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h post-dose.|QT/QTc population.|||bpm||Standard Error|Least Squares Mean
2535568|NCT03203564|Secondary|Relationship Between ΔΔQTc and Modufolin® (and Metabolites) Plasma Concentrations|Predicted ΔΔQTcF interval at geometric mean Cmax for 5,10-MTHF, THF, and 5-Formyl-THF and geometric mean concentration of 5-Methyl-THF observed at 5 minutes post-dose The relationship between plasma concentrations of 5,10-MTHF, THF, 5-Methyl-THF, and 5-Formyl-THF, and change-from-baseline QTcF (ΔQTcF) was quantified using a linear mixed-effects modeling approach with separate analyses for each of the analytes (5,10-MTHF, THF 5-Methyl-THF, and 5-Formyl-THF) initially, with ΔQTcF as the dependent variable, plasma concentration of 5,10-MTHF (or THF, 5-Methyl-THF, or 5-Formyl-THF) as a continuous covariate (i.e., 0 for placebo), centered baseline QTcF as an additional covariate, treatment (active = 1 or placebo = 0) and time (i.e., time point) as categorical factors, and a random intercept and slope per subject. The degrees of freedom estimates were determined by the Kenward-Roger method.|5 minute post-dose time point||||msec / ng/mL||90% Confidence Interval|Geometric Mean
2535569|NCT03203564|Primary|Change-from-baseline QTcF (ΔQTcF)|"At each nominal time point specified in the CSP, up to 10 ECG replicates were extracted with TQT Plus methods. TQT Plus ECG extraction technique: Twelve-lead ECGs were extracted from continuous recordings (Holter recordings) prior to and serially after IMP administration at time points as shown in the Schedule of events. Subjects were supinely resting for at least 10 min prior to time points for ECG recordings.~The 12-lead Holter and ECG equipment were supplied and supported by iCardiac Technologies, Inc.~For all ECG parameters, baseline is defined as the average of the measured ECG intervals from the three pre-dose time points (45, 30, and 15 min pre-dose) on Day 1."|Pre-dose at following timepoints -2 h, -45 min, -30 min, -15 min. Then at following timepoints; 0, 5 min, 15 min, 30 min, 1 h, 2h, 3h, 4h, 5h, 6h, 8h, 12h and 24h post-dose.|The QT/QTc Analysis Set includes all subjects in the Safety Analysis Set with measurements at baseline as well as on-treatment with at least one post-dose time point with a valid ΔQTcF (change from baseline QTcF) value.|||msec||Standard Error|Least Squares Mean
2535570|NCT03203291|Secondary|Berg Balance Scale|Berg Balance Scale measures balance ability of adults. The scale has 14 items, each is rated on a 5-point scale ranging from 0-4. A score of 0 indicates the lowest level of function and 4 indicating the highest level of function. Total scores range from 0-56, with higher scores indicating better balance.|Baseline through week 3||||units on a scale||Standard Deviation|Mean
2535571|NCT03203291|Secondary|Time Spent in Double Support Phase of Gait|The percentage of time in one gait cycle spent in double support phase of gait (2 feet in contact with the ground).|Baseline through week 3||||percentage of gait cycle||Standard Deviation|Mean
2535572|NCT03203291|Secondary|Symmetry of Percentage of Time in Swing Phase of Gait|0-1 symmetry ratio compares the amount of time the unaffected leg is in swing phase of the gait cycle compared to the affected leg. The swing phase means the period of time during the gait cycle when one foot is not in contact with the ground. If the unaffected limb performs equivalent to the affected limb, the ratio has a value of 1. The greater the disparity between limbs, the closer the ratio is to 0.|Baseline through week 3||||ratio||Standard Deviation|Mean
2535573|NCT03203291|Secondary|Gait Velocity|Walking velocity (speed) measured in meters walked per second (measured by Inertial Measurement Unit sensors worn in real time during walking).|Baseline through week 3||||Continuous value (meters/second)||Standard Deviation|Mean
2536690|NCT03159299|Secondary|Diabetes Self-management|Measured by the Summary of Diabetes Self-Care Activities questionnaire, a multi-dimensional12-item scale with items on general diet, specific diet, monitoring blood glucose, foot care, and smoking|Baseline|||||||
2535577|NCT03202550|Secondary|Pain Score 15 Minutes After Last Dilator Placed|Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever). This was to be assessed at 15 minutes after last dilator is placed. Some participants had this assessment done up to 45 minutes after last dilator was placed because it could not be done at 15 minutes (some were being attended to by a nurse at the 15 minutes mark).|Assessed up to 45 minutes after last dilator placed|One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants.|||units on a scale||Inter-Quartile Range|Median
2535578|NCT03202550|Secondary|Pain Score After First Dilator Placement|Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)|pain score given immediately after first dilator placed, up to 1 minute|One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants.|||units on a scale||Inter-Quartile Range|Median
2535579|NCT03202550|Secondary|Pain Score During Paracervical Block|Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)|pain score given at time of paracervical block administration, up to 1 minute|One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants.|||units on a scale||Inter-Quartile Range|Median
2535580|NCT03202550|Secondary|Pain Score at Tenaculum Placement|Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)|Immediately scored at time of tenacula placement, up to 1 minute|One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants.|||units on a scale||Inter-Quartile Range|Median
2535581|NCT03202550|Secondary|Pain Score After Speculum Placement|Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)|pain score given at time of speculum placement, up to 1 minute|One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants.|||units on a scale||Inter-Quartile Range|Median
2535582|NCT03202550|Secondary|Pain Score Before Speculum Placement|Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)|pain score given before specula placed, up to 1 minute|One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants.|||units on a scale||Inter-Quartile Range|Median
2535583|NCT03202550|Secondary|Baseline Pain Score Before Drugs Were Administered|Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)|pain score given prior to administration of study drugs, up to 1 minute|One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants.|||units on a scale||Inter-Quartile Range|Median
2535584|NCT03202550|Secondary|Number of Participants With Desired Number of Dilators Inserted|Assess whether desired number of dilators was not able to be successfully inserted, comparing 2 arms.|After speculum removed, up to 30 minutes|One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants.|||Participants|||Count of Participants
2535585|NCT03202550|Primary|Cervical Dilator Placement Pain as Assessed by VAS on a Tablet Device|Compare pain scores on a 100 mm visual analog scale (VAS) (anchors 0=no pain; 100=worst pain ever)|Immediately after the last dilator is placed, up to 1 minute|One participant in the active drug arm was determined to not need to have cervical dilators placed, so this participant was not included in the total number of active drug arm participants.|||units on a scale||Inter-Quartile Range|Median
2535586|NCT03201900|Secondary|Number of Participants With Any Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Event (TESAEs), and TEAEs Leading to Discontinuation of the Study Drug||From baseline up to 28 days after last dose of study drug (up to 160 weeks)|The safety analysis set was the group of participants who signed informed consent, received at least one dose of study drug and had at least one postdose safety assessment.|||Participants|||Count of Participants
2535587|NCT03201900|Secondary|Time to Withdrawal From Study From the First Date of the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel|Time to withdrawal from the study was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the date of withdrawal from study, regardless of reason. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. Data for this outcome measure will be reported after study completion (which is planned for 2020).|From the first date of the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks)||2020-11-30|11/2020||||
2535588|NCT03201900|Secondary|Time to Withdrawal From Study From the First Date of the Maintenance Period of 4 mg Perampanel|Time to withdrawal from the study was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the date of withdrawal from study, regardless of reason. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. Data for this outcome measure will be reported after study completion (which is planned for 2020).|From the first date of the Maintenance Period (Week 6) up to the date of first withdrawal, regardless of reason (up to 150 weeks)||2020-11-30|11/2020||||
2535589|NCT03201900|Secondary|Time to First Seizure Onset From Study From the First Date of the Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel|Time to onset of first seizure was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the onset of first seizure. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. Data for this outcome measure will be reported after study completion (which is planned for 2020).|From the first date of the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks)||2020-11-30|11/2020||||
2535622|NCT03198000|Secondary|My Eye Appears to Sparkle - 2 Minutes After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|2 minutes after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535590|NCT03201900|Secondary|Time to Onset of First Seizure From Study From the First Date of the Maintenance Period of 4 mg Perampanel|Time to onset of first seizure was defined as the period from the first dose of study drug in the 4 mg Maintenance Period to the onset of first seizure. A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. Data for this outcome measure will be reported after study completion (which is planned for 2020).|From the first date of the Maintenance Period (Week 6) up to the first seizure onset (up to 150 weeks)||2020-11-30|11/2020||||
2535591|NCT03201900|Secondary|Percentage of Participants With POS Who Achieved Seizure-free Status During 52-weeks of Treatment (26-week Maintenance Period Plus 26-weeks of 124 Week's Extension Phase) of Last Evaluated Dose of 4 or 8 mg Perampanel|A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 52-weeks Treatment of last evaluated dose of 4 or 8 mg perampanel. Data for this outcome measure will be reported after study completion (which is planned for 2020).|up to 52 weeks (Maintenance Period of last evaluated dose of 4 or 8 mg perampanel + Extension Phase of 4 or 8 mg perampanel)||2020-11-30|11/2020||||
2535592|NCT03201900|Secondary|Percentage of Participants With POS Who Achieved Seizure-free Status During 52-weeks of Treatment (26-week Maintenance Period Plus 26-weeks of 124 Week's Extension Phase) of 4 mg of Perampanel|A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 52-weeks Treatment of 4 mg perampanel. Data for this outcome measure will be reported after study completion (which is planned for 2020).|up to 52 weeks (Maintenance Period of 4 mg perampanel + Extension Phase of 4 mg perampanel)||2020-11-30|11/2020||||
2535593|NCT03201900|Secondary|Percentage of Participants With POS Who Achieved Seizure-free Status During the 26-week Maintenance Period of Last Evaluated Dose of 4 or 8 mg Perampanel|A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 26-week Maintenance Period of last evaluated dose of 4 or 8 mg perampanel.|up to 26 weeks in Maintenance Period of last evaluated dose of 4 or 8 mg perampanel|mITT set: group of participants who signed informed consent, received at least 1 dose of study drug, had at least 1 postdose primary efficacy measurement and who entered 4 mg Maintenance Period with at least 1 postdose primary efficacy measurement in 26-week Maintenance Period.|||percentage of participants|||Number
2535594|NCT03201900|Primary|Percentage of Participants With Partial-onset Seizures (POS) Who Achieved Seizure-free Status During the 26-week Maintenance Period of 4 mg Perampanel|A seizure was a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. POS was a seizure that starts in one area of the brain that may or may not associated with loss of awareness and consciousness. Seizure-free status was defined as no incidence of seizure during 26-week Maintenance Period of 4 mg perampanel.|up to 26 weeks in Maintenance Period of 4 mg perampanel|Modified intent to treat (mITT) set: group of participants who signed informed consent, received at least 1 dose of study drug, had at least 1 postdose primary efficacy measurement and who entered 4 mg Maintenance Period with at least 1 postdose primary efficacy measurement in 26-week Maintenance Period.|||percentage of participants|||Number
2535595|NCT03200925|Post-Hoc|Number of Participants With Formal Education About Skin to Skin Contact|Measuring formal education training about skin to skin contact prior to admission, provided at either a prenatal appointment or a formal class led by either a nurse or a lactation consultant.|Prior to admission for delivery||||Participants|||Count of Participants
2535596|NCT03200925|Primary|Actual Practice of Skin-to-skin Contact After Birth|For both video and non-video groups, skin to skin duration (minutes) after delivery will be calculated. The time in minutes from delivery to initiation of skin to skin contact is also collected. This information will allow us to determine if video education impacts the actual practice of skin-to-skin contact after birth.|1 week||||minutes||Full Range|Median
2535597|NCT03200925|Primary|Intention to Practice Skin-to-skin Contact After Birth|"Both groups will be asked a short survey at the time of admission:~their intention to practice skin to skin at the time of delivery~if they participated in skin to skin in a previous pregnancy~if they had any formal education about skin to skin~if they did have formal education was it either~a.) Provided at a prenatal appointment~b.) A formal class led by either a nurse or a lactation consultant Group B will watch a short video about skin-to-skin contact and will be then reasked a question regarding their intention to practice skin-to-skin contact after birth. This information will allow us to determine if video education impacts the intention to practice skin-to-skin contact after birth."|1 day||||Participants|||Count of Participants
2535598|NCT03200912|Primary|Complete Clearance of AK Lesions|Treatment success (complete clearance of AK lesions) at Day 57, where complete clearance of AK lesions was defined as having no (zero) clinically visible AK lesions in the Treatment Area|57 days|AK Complete Clearance Rate at Day 57 (PP population)|||Participants|||Count of Participants
2535599|NCT03200860|Other Pre-specified|Serious Adverse Events|SAE including all cause mortality. Per request Clintrials.gov different from Protocol definition|60 days||||Participants|||Count of Participants
2535600|NCT03200860|Secondary|All Cause Mortality|All Cause Mortality at 60 days|60 day||||Participants|||Count of Participants
2535601|NCT03200860|Secondary|Inhospital Worsening Heart Failure, All Cause Mortality or Heart Failure Readmission at Day 60|Inhospital Worsening Heart Failure or All Cause mortality or Heart Failure Readmission at day 60|60 days||||Participants|||Count of Participants
2535602|NCT03200860|Secondary|Death and/or Heart Failure Re-admission|Death and/or heart failure re-admission at day 30|Day 30||||Participants|||Count of Participants
2535603|NCT03200860|Primary|Plasma NTproBNP|Change in NTproBNP|From baseline to Day 4||||% change in NTproBNP at day 4||Standard Deviation|Mean
2535604|NCT03200860|Primary|Length of Stay|Hospital stay of Index admission|within 60 days||||days||Inter-Quartile Range|Median
2535605|NCT03200860|Primary|Diuretic Response|Weight change from baseline per 40 mg of Furosemide equivalent|Total weight change from baseline to Day 4||||kg/40 mg Furosemide equivalent at day 4||Standard Deviation|Mean
2535606|NCT03200860|Primary|Dyspnea|"Change in Dyspnea on VAS analogue scale (AUC)~VAS Score is a measure/scale where patients on a scale from 0 to 100 can assign their current dyspnea score. 0 means there can be no worse dyspnea, 100 means it cannot get any better (perfect).~The change in Dyspnea VAS means higher score is better outcomes.~Individual changes in VAS score are be visualized (virtually) as a curve where the X-axis shows study day baseline to day 4, and y-axis shows VAS score. Using this approach, area under the curves for each study day (trapezoids) can be calculated, and added together, resulting in an overall VAS AUC score (mmxh) and change in VAS can be caculated"|From baseline to Day 4||||mmxh||Standard Deviation|Mean
2535607|NCT03200535|Secondary|Enrollment in Diabetes Prevention or Weight Management Class (in Person)|Percent of individuals who have enrolled in diabetes prevention or weight management class (in person) over a 4.5 month follow-up period|4.5 months (6/26/2017-11/10/2017)||||Participants|||Count of Participants
2535608|NCT03200535|Primary|Enrollment in Diabetes Prevention or Weight Management Class (Online)|Percent of individuals who have enrolled in online diabetes prevention or weight management classes (online) over a 4.5 month period|4.5 months (6/26/2017-11/10/2017)|Entire population was analyzed|||Participants|||Count of Participants
2535609|NCT03199079|Secondary|Cervix Length|Cervix length in mm|During examination procedure||||mm||Standard Deviation|Mean
2535610|NCT03199079|Primary|Cervix Elasticity|Young's modulus of the cervix at 4 locations. Units of measurement is kPa.|During examination procedure||||kPa||Standard Deviation|Mean
2535611|NCT03198767|Secondary|Average Stool Weight (Part A and Part B)|24 hour average stool weight on day 3|24 hours on Day 3 of each treatment period|PD Analysis Set|||gram||Standard Deviation|Mean
2535612|NCT03198767|Secondary|Average Stool pH (Part A and Part B)|Average PH of Stool at day 3|24 hours on Day 3 of each treatment period|PD Analysis Set|||pH||Standard Deviation|Mean
2535613|NCT03198767|Secondary|Average Consistency With Bristol Stool Chart (Part A and Part B)|BSC is frequently used as a measure of consistency, ranging from score 1 (hard lumps) to 7 (watery stool).|24 hours on Day 3 of each treatment period|PD Analysis Set.|||score||Standard Deviation|Mean
2535614|NCT03198767|Secondary|Three-day Total Number of Episodes of Diarrhea (Part A and Part B)|Episodes of diarrhea is defined as the total number of stools with a Bristol Stool Chart (BSC) Score of 6 or 7 on days 1 to 3 of each treatment period. BSC is frequently used as a measure of consistency, and a score of 6 or 7 (pourable or watery stool) is considered abnormal.|Day 1 to 3 of each treatment period|PD Analysis Set. All subjects with any available pharmacodynamic (PD) data and no major protocol deviations with impact on PD data.|||Number of stools||Standard Deviation|Mean
2535615|NCT03198767|Primary|Number of Episodes of Diarrhea (Part A and Part B)|Episodes of diarrhea is defined as the total number of stools with a Bristol Stool Chart (BSC) Score of 6 or 7 on day 3 of each treatment period. BSC is frequently used as a measure of consistency, and a score of 6 or 7 (pourable or watery stool) is considered abnormal.|24 hours on Day 3 of each treatment period|PD Analysis Set. All subjects with any available pharmacodynamic (PD) data and no major protocol deviations with impact on PD data.|||Number of stools||Standard Deviation|Mean
2535616|NCT03198507|Other Pre-specified|Number of Participants With Eradication of H. Pylori in the Pharmacokinetic Population (PKP)|"A pre-specified responder analysis of eradication of H. pylori confirmed via 13C Urea Breath Test (UBT) was performed in the PK population.~The PK population was generated based on the measurement of plasma concentrations of amoxicillin, omeprazole, rifabutin, and the rifabutin metabolite 25-O-desacetyl-rifabutin (on Day 13). It included those subjects in the FAS who had demonstrable presence of any component of investigational drug at Visit 3 or had no levels detected >250 hours after the last dose. For all subjects, the reason for exclusion from the PKP was the absence of any pharmacokinetic component of study drug at Visit 3 within 250 hours of the last reported dose. Two hundred fifty hours was selected to account for approximately 10 times the terminal half-life of rifabutin."|43-71 days after initiation of treatment|Pharmacokinetic Population (PKP)|||Participants|||Count of Participants
2535617|NCT03198507|Secondary|Number of Participants With Adverse Events That Are Related to Treatment|The number of participants that presented treatment emergent adverse events (TEAE) during the study overall, TEAEs related to study drug and severe TEAEs.|After first dose of study drug until 28 days following last dose.|Safety Population|||Participants|||Count of Participants
2535618|NCT03198507|Secondary|Number of Participants With H. Pylori Cultures That Presented Antibiotic Resistance and Susceptibility|"The primary endpoint was summarized within subgroups formed by the presence of H. pylori susceptibility and resistance to amoxicillin, clarithromycin, metronidazole, and rifabutin from H. pylori cultures from samples obtained prior to initiating study treatment (i.e. baseline).~A participant is considered a responder when H. pylori is eradicated after treatment as confirmed via 13C Urea Breath Test (UBT). A participant is considered a non-responder when H. pylori is not eradicated after treatment."|43-71 days after initiation of treatment|n is the number of cultures obtained from the in the FAS population in each treatment group with H. pylori resistant/susceptible to Rifabutin, Amoxicillin, Clarithromycin or Metronidazole at baseline|||Participants|||Count of Participants
2535619|NCT03198507|Primary|Number of Participants With Eradication of H. Pylori|Eradication of H. pylori confirmed via 13C Urea Breath Test (UBT) testing. Subjects with negative test results (eradication of H. pylori) were considered treatment successes. Subjects who tested positive for H. pylori infection (no eradication) were considered treatment failures.|43-71 days after initiation of treatment|Full Analysis Set (FAS)|||Participants|||Count of Participants
2535620|NCT03198000|Secondary|My Eye Appears to Sparkle - 12 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|12 hours after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535621|NCT03198000|Secondary|My Eye Appears to Sparkle - 10 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|10 hours after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2536691|NCT03159299|Secondary|Change in Body Mass Index (BMI) From Baseline|A calibrated electronic scale will be used to record weight and a wall-based stadiometer will be used to record height. Weight and height will be combined to report BMI in kg/m^2.|6 months|||||||
2535623|NCT03198000|Secondary|My Eye Appears to Sparkle - Baseline|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|Baseline|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535624|NCT03198000|Secondary|My Eye Feels Cool - 12 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|12 hours after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535625|NCT03198000|Secondary|My Eye Feels Cool - 10 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|10 hours after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535626|NCT03198000|Secondary|My Eye Feels Cool - 2 Minutes After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|2 minutes after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535627|NCT03198000|Secondary|My Eye Appears Healthy - 12 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|12 hours after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535628|NCT03198000|Secondary|My Eye Appears Healthy - 10 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|10 hours after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535629|NCT03198000|Secondary|My Eye Appears Healthy - 2 Minutes After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|2 minutes after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535630|NCT03198000|Secondary|My Eye Appears Healthy - Baseline|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|Baseline|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535631|NCT03198000|Secondary|The Appearance of my Eye Can Show How I Really Feel - 12 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|12 hours after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535632|NCT03198000|Secondary|The Appearance of my Eye Can Show How I Really Feel - 10 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|10 hours after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535633|NCT03198000|Secondary|The Appearance of my Eye Can Show How I Really Feel - 2 Minutes After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|2 minutes after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535634|NCT03198000|Secondary|The Appearance of my Eye Can Show How I Really Feel - Baseline|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|Baseline|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535635|NCT03198000|Secondary|The Appearance of my Eye Gives me Confidence to Approach Others - 12 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|12 hours after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535636|NCT03198000|Secondary|The Appearance of my Eye Gives me Confidence to Approach Others - 10 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|10 hours after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535637|NCT03198000|Secondary|The Appearance of my Eye Gives me Confidence to Approach Others - 2 Minutes After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|2 minutes after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535638|NCT03198000|Secondary|The Appearance of my Eye Gives me Confidence to Approach Others - Baseline|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|Baseline|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535639|NCT03198000|Secondary|My Eye Feels Refreshed - 12 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|12 hours after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535640|NCT03198000|Secondary|My Eye Feels Refreshed - 10 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|10 hours after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535641|NCT03198000|Secondary|My Eye Feels Refreshed - 2 Minutes After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|2 minutes after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535642|NCT03198000|Secondary|My Eye Feels Hydrated - 12 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|12 hours after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535643|NCT03198000|Secondary|My Eye Feels Hydrated - 10 Hours After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|10 hours after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535644|NCT03198000|Secondary|My Eye Feels Hydrated - 2 Minutes After First Application|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|2 minutes after first application|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535645|NCT03198000|Secondary|My Eye Feels Hydrated - Baseline|Subject questionnaire. Assessed on a 5-point scale (1-5) where 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree or disagree, 4 = somewhat agree, and 5 = strongly agree, where a higher score was better. No opinion was also allowed.|Baseline|Intent-to-treat set|||Percentage of participants|Eyes||Number
2535646|NCT03198000|Secondary|Change From Baseline in Ocular Comfort at 12 Hours After First Product Application|Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.|Baseline to 12 hours after first product application|Intent-to-treat set|||units on a scale|eyes|Standard Error|Mean
2535647|NCT03198000|Secondary|Change From Baseline in Ocular Comfort at 10 Hours After First Product Application|Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.|Baseline to 10 hours after first product application|Intent-to-treat set|||units on a scale|eyes|Standard Error|Mean
2535648|NCT03198000|Secondary|Change From Baseline in Ocular Comfort at 60 Seconds After First Product Application|Ocular comfort was assessed on an 11-point visual analog scale (0-10) where 0 = very uncomfortable and 10 = very comfortable, where a higher score was better.|Baseline to 60 seconds after first product application|Intent-to-treat set|||units on a scale|eyes|Standard Error|Mean
2535649|NCT03198000|Secondary|Clinician Assessment of Baseline Redness|Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.|Baseline|Intent-to-treat set|||units on a scale|eyes|Standard Deviation|Mean
2535650|NCT03198000|Secondary|Clinician Assessment of Change From Baseline in Redness at 2 Minutes After First Product Application|Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.|Baseline to 2 minutes after first product application|Intent-to-treat set|||units on a scale|eyes|Standard Error|Mean
2535651|NCT03198000|Secondary|Clinician Assessment of Change From Baseline in Redness at 30 Seconds After First Product Application|Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.|Baseline to 30 seconds after first product application|Intent-to-treat set|||units on a scale|eyes|Standard Error|Mean
2535652|NCT03198000|Primary|Percentage of Participants With Response to Redness at 60 Seconds After First Product Application|The responder was defined as a subject whose assessment score at 60 seconds after the initial eye drop is less than the assessment score at baseline. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.|Baseline to 60 seconds after first product application|Intent-to-treat set|||Percentage|Eyes||Number
2535653|NCT03198000|Primary|Clinician Assessment of Change From Baseline in Redness at 60 Seconds After First Product Application|Mean change from baseline in redness. Redness was assessed on a 5-point severity scale with 0.5 increments (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extremely severe), where a lower score is better.|Baseline to 60 seconds after first product application|Intent-to-treat set|||units on a scale|eyes|Standard Error|Mean
2535654|NCT03197883|Secondary|Global Self-assessment of Participants|Participants has rated the level of satisfaction with the post-procedure skin care regimen to which they were randomized on a scale of 0 to 3 as follows: 0 (Very satisfied), 1 (Satisfied), 2 (Poorly satisfied), 3 (Not at all satisfied). Lower scores indicate better results.|14 days after completion of the facial peel procedure|Global self-assessment of satisfaction was measured on ITT population (N=91). Population was based on treatment to which participant was randomized. Of which, there were 50 in test product and 46 in no treatment. Here, number of participants (n=91) analyzed signifies those who were evaluated.|||Participants|||Count of Participants
2535670|NCT03197376|Secondary|Comparison of Functional Response (OPA) From 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose|Comparison of Serotype-specific booster responses (functional response-OPA) from 4 weeks after a 3-dose primary series to 4 weeks after a booster dose|4 weeks post booster vaccination|In a subset who got 3 primary series+booster dose of study vaccines, had postdose immunogenicity measurement & no major PDs, comparisons based on ratios of OPA GMT post booster to OPA GMT post primary series. Comparison done using ratios of the ratios for the 2 treatment groups (PNEUMOSIL ratio/Synflorix ratio), & corresponding 95% CIs.|||titer||95% Confidence Interval|Geometric Mean
2535655|NCT03197883|Secondary|Change From Baseline in Instrumental Measurement of Moisturisation Using Corneometer|Measurement of stratum corneum hydration was performed by the electrical capacitance method with a Corneometer. Corneometer measurements were taken in triplicates at the left cheek (below the cheekbone, between the nose and ear) with the participant lying horizontally, on their back. An increase in corneometry values indicates an increase in the hydration status of the skin and vice versa.|14 days after completion of the facial peel procedure|Analysis of Corneometry was measured on Intent to Treat (ITT) population (N=96). Population was based on treatment to which participant was randomized. Of which, there were 50 in test product and 46 in no treatment. Here, number of participants (n=91) analyzed signifies those who were evaluated.|||Corneometer Units||Standard Deviation|Mean
2535656|NCT03197883|Secondary|Change From Baseline in Instrumental Measurement of Barrier Function Using Tewameter|Trans-epidermal water loss (TEWL) measurement was performed by evaporimetry with a Tewameter. Measurements were taken in triplicates on the left cheek (below the cheekbone between the nose and ear). TEWL measurements were taken with the participant lying horizontally, on their back, so that the chimney of the Tewameter probe is aligned vertically. An increase in TEWL values shows damage to the skin barrier function.|14 days after completion of the facial peel procedure|Analysis of TEWL was performed on Intent-to-Treat (ITT) population(N=96). Population was based on treatment to which participant was randomized. Of which, there were 50 in test product and 46 in no treatment. Here, number of participants (n=91) analyzed signifies those who were evaluated.|||g/m^2/hr||Standard Deviation|Mean
2535657|NCT03197883|Secondary|Change From Baseline in Participant Self-assessment Scores for Dryness|The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for dryness. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results.|14 days after completion of the facial peel procedure|The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.|||Score on Scale||Standard Deviation|Mean
2535658|NCT03197883|Secondary|Change From Baseline in Participant Self-assessment Scores for Tightness|The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for tightness. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results.|14 days after completion of the facial peel procedure|The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.|||Score on Scale||Standard Deviation|Mean
2535659|NCT03197883|Secondary|Change From Baseline in Participant Self-assessment Scores for Stinging/Burning|The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for stinging/burning. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results.|14 days after completion of the facial peel procedure|The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.|||Score on Scale||Standard Deviation|Mean
2535660|NCT03197883|Secondary|Change From Baseline in Participant Self-assessment Scores for Itching|The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for itching. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results.|14 days after completion of the facial peel procedure|The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.|||Score on Scale||Standard Deviation|Mean
2535661|NCT03197883|Secondary|Change From Baseline in Participant Self-assessment Scores for Pain|The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for pain. Participants were scored on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results.|14 days after completion of the facial peel procedure|The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.|||Score on Scale||Standard Deviation|Mean
2535662|NCT03197883|Secondary|Change From Baseline in Participant Self-assessment Scores for Redness|The following assessments were conducted by participants reflective of their skin condition at the time of evaluation for redness. Participants were score on a scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Lower scores indicate better results.|14 days after completion of the facial peel procedure|The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.|||Score on Scale||Standard Deviation|Mean
2535671|NCT03197376|Secondary|Serotype-specific Geometric Mean Concentration of IgG Antibody Response and Treatment-Group GMC Ratios 4 Weeks After a Booster Dose|Comparison of Serotype-specific booster responses (antibody concentrations) to PNEUMOSIL in comparison to Synflorix 4 weeks after a booster dose|4 weeks post booster vaccination|In a subset of subjects who got 3 primary series and a booster dose of study vaccines, had postdose immunogenicity measurement(s) with no major protocol deviations, serotype-specific GMC of IgG Antibody and treatment group ratios of IgG GMCs (with corresponding 95% CIs) were evaluated. Pooled PNEUMOSIL data was used for this analysis as per SAP|||µg/mL||95% Confidence Interval|Geometric Mean
2536692|NCT03159299|Secondary|Change in Body Mass Index (BMI) From Baseline|A calibrated electronic scale will be used to record weight and a wall-based stadiometer will be used to record height. Weight and height will be combined to report BMI in kg/m^2.|3 months|||||||
2535663|NCT03197883|Secondary|Change From Baseline in Sum of Participant Self-assessment Scores for Redness, Pain, Stinging/Burning, Itching, Tightness and Dryness|The assessments of Pain, Stinging/ Burning, Itching, Tightness, Redness and Dryness were conducted by participants reflective of their skin condition at the 5 x 5 cm square area on the volar surface of the forearm at the time of evaluation. Participants were scored as per signs/symptom: pain, stinging/burning, itching, tightness, redness and dryness on scale of 0 to 3, where 0= none; no sign or symptoms, 1= mild; barely perceptible, 2= moderate; definite signs and symptoms, and 3= severe- marked or pronounced signs or symptoms. This outcome measure is the sum of participant scores, so a total score, i.e. the range is 0-15, with higher scores indicating increased signs or symptoms of irritation.|14 days after completion of the facial peel procedure|The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.|||Score on Scale||Standard Deviation|Mean
2535664|NCT03197883|Secondary|Number of Participants Reporting no/Mild/Moderate/Severe Change From Baseline in Individual Dermatologist Scores for Erythema, Edema, Desquamation and Dryness|The signs/symptoms of participants were scored on a scale of 0 to 3 as below: Erythema: Score from 0=None-No evidence of erythema present, 1=Mild-Slight red coloration, 2=Moderate-Definite redness, 3=Severe-Marked erythema, bright red to dusky dark red in color. Dryness: Score from 0=None-No dryness, 1=Mild-Barely perceptible, fine scales or flakes present to limited areas of the test site, 2=Moderate-Fine scales or flakes generalized to all areas of the test site, 3=Severe -Scaling and peeling of skin over all areas of the test site. Desquamation score from 0=None-No evidence of desquamation/peeling, 1=Mild-Barely perceptible scaling; evident only on scratching, 2=Moderate-Minimal scaling, adherent to the skin, 3=Severe -Moderate scaling, loosely adherent to the skin and easily removable. Edema score from 0=None-No edema present, 1=Mild-Barely perceptible edema present, 2=Moderate-Definite edema present, 3=Severe-Marked/pronounced edema present.|14 days after completion of the facial peel procedure|The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.|||Participants|||Count of Participants
2535665|NCT03197883|Secondary|Change From Baseline in Total Score of Dermatologist Assessments|The assessments of Erythema, Dryness, Desquamation and Edema were conducted by a dermatologist on the participant's skin condition at the 5 x 5 cm square area on the volar surface of forearm. The signs were scored on a scale. Erythema on 0-3 where, 0=none-no redness, 1=mild-slight redness, 2=moderate-definite redness, 3=severe-marked redness. Dryness on 0-3 where, 0=none-no dryness, 1=mild-barely perceptible, fine scales to limited areas of test site, 2=moderate-fine scales generalized to all areas of test site, 3=severe-scaling and peeling of skin over all areas of test site. Desquamation on 0-3 where, 0=none-no sign of peeling, 1=mild-barely perceptible scaling, 2=moderate-minimal scaling, 3=severe-moderate scaling. Edema on 0-3 where, 0=none-no edema, 1=mild-barely perceptible edema, 2=moderate-definite edema, 3=severe-pronounced edema. The measure is sum of participant scores, so a total score scale ranges from 0-12, with higher scores indicating increased signs of irritation.|14 days after completion of the facial peel procedure|The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.|||Score on Scale||Standard Deviation|Mean
2535666|NCT03197883|Primary|Number of Participants Reporting Product Tolerability Based on Evaluator Global Assessment Scores|The dermatologist assessed the local tolerance of the post-procedure skin care regimen in context of the expected effects of the procedure for each participant using the scale as below: 0 - Product regimen was well tolerated, 1 - product regimen was not well tolerated. The dermatologist observed on the total set of clinical and participant self-assessment data for each participant. Lower scale value implies that no clinically significant worsening of the expected signs/symptoms of the procedure, no new signs/symptoms manifest during product use. Whereas, higher scale value implies clear, clinically relevant worsening of the severity or frequency of expected signs/symptoms of the procedure and/or any occurrence of new, unexpected signs/symptoms during product use.|14 days after completion of the facial peel procedure|The safety population (N=96) included all participants with at least 1 application of product in test phase. This population was based on treatment the participant actually received. Of which, there were 50 in test product and 46 in no treatment. Number of participants (n=91) analyzed in this outcome measure signifies those who were evaluated.|||Participants|||Count of Participants
2535667|NCT03197558|Primary|Subject-reported Pain Score Following Tube Delivery System (TDS) Tube Placement Using the Visual Analogue Scale (VAS) by Subject Compared to a Performance Goal.|"The VAS consists of a 100 millimeter (mm) line with a statement at each end representing the extreme limits of pain intensity where a score of 0 represents No pain and a score of 100 represents The worst possible pain.~Following TDS tube placement, the subject will report their post-tube placement ear discomfort for each ear undergoing tube placement using the VAS. For subjects treated bilaterally, the highest (worst) score reported will be used as the unit of analysis."|Day of procedure (Day 0)- Immediately after tube placement||||millimeters||Standard Deviation|Mean
2535668|NCT03197376|Secondary|Number and Percentage of Subjects With EPI Vaccine Immune Responses (Measles, Rubella and Yellow Fever)|Anti-measles IgG, anti-rubella IgG and anti-yellow fever neutralizing antibody titer|4 weeks post booster vaccination|Evaluated in a subset who got 3 primary doses and a booster dose, had postdose immunogenicity data with no major protocol deviations. Non-inferiority shown if 2-sided 95% CI for difference in response proportions (PNEUMOSIL-Synflorix) had lower limit >-0.10. For this, pooled PNUEMOSIL data was used as specified in SAP.|||Participants|||Count of Participants
2535669|NCT03197376|Secondary|Serotype-specific OPA GMT and Treatment-Group GMT Ratios 4 Weeks After a Booster Dose|Comparison of Serotype-specific booster responses (functional response) to PNEUMOSIL in comparison to Synflorix 4 weeks after a booster dose|4 weeks post booster vaccination|In a subset of subjects who got 3 primary series and a booster dose of study vaccines, had postdose immunogenicity measurement(s) with no major protocol deviations, serotype-specific OPA GMT and treatment group ratios of OPA GMT (with corresponding 95% CIs) were evaluated. Pooled PNEUMOSIL data was used for this analysis as per SAP|||titer||95% Confidence Interval|Geometric Mean
2535672|NCT03197376|Secondary|Comparison of Serotype-specific Geometric Mean Concentration of IgG Antibody Response 4 Weeks After a 3-dose Primary Series to 4 Weeks After a Booster Dose|Comparison of Serotype-specific booster responses (antibody concentrations) measured by ELISA from 4 weeks after a 3-dose primary series to 4 weeks after a booster dose|4 weeks post booster vaccination|In a subset who got 3 primary series+booster dose of study vaccines, had postdose immunogenicity measurement & no major PDs, comparisons based on ratios of IgG GMC post booster to IgG GMC post primary series. Comparison done using ratios of the ratios for the 2 treatment groups (PNEUMOSIL ratio/Synflorix ratio), & corresponding 95% CIs.|||µg/mL||95% Confidence Interval|Geometric Mean
2535673|NCT03197376|Secondary|Serotype-specific OPA Geometric Mean Titer|Serotype-specific functional antibody titer measured by OPA and expressed as OPA GMT in a subset|4 weeks after the third dose|In a subset of subjects who got 3 primary doses of study vaccines, had postdose immunogenicity measurement and no major protocol deviations, functional immune responses induced by PNEUMOSIL were compared to Synflorix for 10 serotypes in PNEUMOSIL, i.e., ratio of OPA GMTs (and corresponding 95% CIs).Pooled PNEUMOSIL data was used as noted in the SAP|||titer||95% Confidence Interval|Geometric Mean
2535674|NCT03197376|Secondary|Number and Percentage of Subjects With Functional Antibody Responses|Serotype-specific functional antibody titer measured by OPA|4 weeks after the third dose|In a subset of subjects who got 3 primary doses of study vaccines, had postdose immunogenicity measurement and no major protocol deviations, functional immune responses induced by PNEUMOSIL were compared to Synflorix for 10 serotypes in PNEUMOSIL, i.e., OPA seroresponse rate (titer≥1:8) differences.Pooled PNEUMOSIL data was used as noted in the SAP|||Participants|||Count of Participants
2535675|NCT03197376|Secondary|6A and 19A Serotype Specific Geometric Mean Concentration of IgG Antibody|6A and 19A Serotype Specific Immune Responses in terms of IgG GMCs measured by ELISA|4 weeks after the third dose|For 6A and 19A serotypes, GMCs were compared by a two-sample t-test on the difference.Test was done at the 2-sided 2.5% significance level to adjust for superiority test.The 95% CIs around treatment-group responses, and 97.5% CIs for treatment-group differences in response were reported.Analysis was done on pooled PNEUMOSIL data as specified in SAP|||µg/mL||95% Confidence Interval|Geometric Mean
2535676|NCT03197376|Secondary|Number and Percentage of Subjects With 6A and 19A Serotype-specific Concentrations of Immunoglobulin G Antibody|Subjects with 6A and 19A serotype-specific concentrations of immunoglobulin G (IgG) antibody measured by ELISA|4 weeks after the third dose|For 6A and 19A serotypes, proportions with IgG concentration ≥ 0.35 µg/mL were compared using a z-test for proportions.Test was done at the 2-sided 2.5% significance level to adjust for superiority test. Analysis was done on pooled PNEUMOSIL data as specified in SAP|||Participants|||Count of Participants
2535677|NCT03197376|Primary|Number and Percentage of All SAEs by Severity and Relatedness|All subjects were followed up for SAEs till 4 weeks post vaccination dose 3 and subjects in the booster cohort were followed up for SAEs till 4 weeks post booster vaccination|4 weeks post last vaccination|Evaluated in all subjects who received a study vaccination and provided some post-vaccination safety data. Treatment groups (PNUEMOSIL or Synflorix) were based on actual treatment received at Visit 1. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used as specified in SAP.|||Participants|||Count of Participants
2535678|NCT03197376|Primary|Number and Percentage of All AEs Including SAEs Occurring in Greater Than 1% Subjects by Severity and Relatedness|All subjects were followed up for AEs till 4 weeks post vaccination dose 3 and subjects in the booster cohort were followed up for AEs till 4 weeks post booster vaccination|4 weeks post last vaccination|Evaluated in all subjects who received a study vaccination and provided some post-vaccination safety data. Treatment groups (PNUEMOSIL or Synflorix) were based on actual treatment received at Visit 1. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used as specified in SAP.|||Participants|||Count of Participants
2535679|NCT03197376|Primary|Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Booster|In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 [none], 1 [mild], 2 [moderate], 3 [severe], 4 [life threatening].|7 days (including day of vaccination)|Reported in a subset of subjects who got 3 doses and booster dose of the study vaccine and had post-vaccination safety data.Treatment groups (PNUEMOSIL or Synflorix) were based on actual treatment received at Visit 1. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used (specified in SAP)|||Participants|||Count of Participants
2535680|NCT03197376|Primary|Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 3|In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 [none], 1 [mild], 2 [moderate], 3 [severe], 4 [life threatening].|7 days (including day of vaccination)|Sample size for evaluation of solicited local and systemic AEs was approx. 1,125. Evaluated in a subset of subjects who got a study vaccine and had some post-vaccination safety data. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used as specified in SAP.|||Participants|||Count of Participants
2535681|NCT03197376|Primary|Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 2|In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 [none], 1 [mild], 2 [moderate], 3 [severe], 4 [life threatening].|7 days (including day of vaccination)|Sample size for evaluation of solicited local and systemic AEs was approx. 1,125. Evaluated in a subset of subjects who got a study vaccine and had some post-vaccination safety data. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used as specified in SAP.|||Participants|||Count of Participants
2535682|NCT03197376|Primary|Number and Percentage of Solicited Local and Systemic Reactogenicity by Severity- Vaccination 1|In the primary reactogenicity cohort, local and systemic reactogenicity of the study vaccine was evaluated through day 6 for severity by toxicity grading scale (0 [none], 1 [mild], 2 [moderate], 3 [severe], 4 [life threatening].|7 days (including day of vaccination)|Sample size for evaluation of solicited local and systemic AEs was approx. 1,125. Evaluated in a subset of subjects who got a study vaccine and had some post-vaccination safety data. Lotwise data was used for clinical lot equivalence evaluation, for safety analyses pooled PNUEMOSIL data was used as specified in SAP.|||Participants|||Count of Participants
2535683|NCT03197376|Primary|Anti Fimbriae 2/3 IgG GMCs for the Pertussis Antigen|Anti fimbriae 2/3 IgG GMCs for the pertussis antigen|4 weeks after the third dose|Evaluated in a subset of subjects who received all primary series doses, had postdose immunogenicity results with no major protocol deviations. Non-inferiority was defined as a two-sided 95% CI for the GMC ratio (PNEUMOSIL/Synflorix) with lower limit > 0.5 for each of 2 separate antigens (pertussis toxoid and fimbriae).|||U/mL||95% Confidence Interval|Geometric Mean
2535684|NCT03197376|Primary|Anti-pertussis Toxoid GMCs for the Pertussis Antigen|Anti-pertussis toxoid GMCs for the pertussis antigen|4 weeks after the third dose|Evaluated in a subset who got 3 primary doses, had postdose immunogenicity data with no major protocol deviations.Non-inferiority was defined as 2-sided 95% CI for the GMC ratio (PNEUMOSIL/Synflorix) with lower limit>0.5 for each of 2 separate antigens (pertussis toxoid and fimbriae).For this analysis, pooled PNUEMOSIL data used as specified in SAP|||IU/mL||95% Confidence Interval|Geometric Mean
2535685|NCT03197376|Primary|Number and Percentage of Subjects With EPI Vaccine Immune Responses (Diphtheria, Tetanus, Hepatitis B, Hib, Polio and Rotavirus)|Subjects with 1) anti-diphtheria toxoid (DT) and anti-tetanus toxoid (DT) IgG concentration ≥ 0.1 IU/mL; 2) anti-Hepatitis B surface antigen (HBsAg) IgG concentration ≥ 10 mIU/mL; 3) anti-Hib (polyribosylribitol phosphate [PRP]) IgG concentration ≥ 0.15 µg/mL; 4) anti-poliovirus types 1, 2 and 3 neutralizing antibody titers ≥ 1:8; 5) anti-rotavirus IgA concentration ≥ 20 U/mL.|4 weeks after the third dose|Evaluated in a subset who got 3 primary doses, had postdose immunogenicity data with no major protocol deviations.For each Ag in the pentavalent, RV, OPV vaccines, non-inferiority shown if 2-sided 95% CI for difference in response proportions (PNEUMOSIL-Synflorix) had lower limit >-0.10. For this, pooled PNUEMOSIL data was used as specified in SAP.|||Participants|||Count of Participants
2535686|NCT03197376|Primary|Serotype-specific Geometric Mean Concentration of IgG Antibody|Serotype-specific immunoglobulin G (IgG) geometric mean concentration (GMC) 4 weeks after the primary series of PNEUMOSIL/Synflorix co-administered with pentavalent, RV and polio vaccines.|4 weeks after the third dose|Non-inferiority for each serotype is based on 2 non-inferiority criteria evaluation: for each serotype, non-inferiority was shown if a two-sided 97.5% CI for the absolute difference in proportions responding (PNEUMOSIL-Synflorix) had a lower limit >-0.10, or if a two-sided 97.5% CI for the IgG GMC ratio (PNEUMOSIL/Synflorix) had a lower limit >0.5.|||µg/mL||95% Confidence Interval|Geometric Mean
2535687|NCT03197376|Primary|Number and Percentage of Subjects With Serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL|Number and Percentage of subjects with serotype-specific IgG Antibody Responses ≥ 0.35 μg/mL|4 weeks after the third dose|Non-inferiority for each serotype is based on 2 non-inferiority criteria evaluation: for each serotype, non-inferiority was shown if a two-sided 97.5% CI for the absolute difference in proportions responding (PNEUMOSIL-Synflorix) had a lower limit >-0.10, or if a two-sided 97.5% CI for the IgG GMC ratio (PNEUMOSIL/Synflorix) had a lower limit >0.5.|||Participants|||Count of Participants
2535688|NCT03197376|Primary|Serotype-specific Geometric Mean Concentration of IgG Antibody|Serotype-specific concentrations of immunoglobulin G (IgG) antibody measured by ELISA|4 weeks after the third dose|All subjects who received all primary series doses of study vaccines, had post-dose immunogenicity measurement(s) with no major protocol deviations|||µg/mL||95% Confidence Interval|Geometric Mean
2535689|NCT03197025|Other Pre-specified|Number of Grade 4 Lymphocyte Count Decreased Dose Limiting Toxicities (DLT)|DLT is defined as all treatment related Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL) and greater adverse events occurring within 30 days of the cell infusion with the exception of the following expected transient effects of aldesleukin. Grade 3 fever or chills responsive to symptomatic treatment that resolve to ≤ grade 2 in 48 hours. Grade 3 hypotension or oliguria responsive to ≤ 1.5L of intravenous fluid boluses in 24 hours that resolves to ≤ grade 2 in 48 hours. Grade 3 dyspnea/hypoxia that improves to ≤ grade 2 or less with supplemental oxygen and resolves to ≤ grade 2 without supplemental oxygen in 48 hours. Grade 3 creatinine or electrolyte abnormalities that resolve to ≤ grade 2 in 48 hours.|within 30 days of cell infusion|The protocol was amended to exclude Grade 3 or higher white blood cell count decreased/lymphocyte count decreased that resolved to less than Grade 2 in 72 hours. This was done since transient lymphopenia is not a clinically significant event.|||Toxicities|||Number
2535690|NCT03197025|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 4 months and 17 days.||||Participants|||Count of Participants
2535691|NCT03197025|Secondary|Number of Participants With a Clinical Response Treated With E6 T Cell Receptor (TCR) T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions (HSIL)|Complete Response (CR) is disappearance of all target lesions. No appearance of new lesions. Partial Response (PR) is a ≥50% decrease in the sum of the product of the longest perpendicular diameters of target lesions, taking as reference the baseline measurements. No appearance of new lesions. No increase of greater than 25% of index lesion. Progressive disease is a ≥25% increase in the sum of the product of the longest perpendicular diameters of target lesions, taking as reference the smallest product on study (this includes the baseline product if that is the smallest on study). In addition to the relative increase of 25%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression. Non-CR/Non-PD is neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest product of diameters while on study.|3 months||||Participants|||Count of Participants
2535705|NCT03196349|Other Pre-specified|Number of Subjects Experiencing Major Bleeding|Major bleeding|Randomization to 12 months||||Participants|||Count of Participants
2535706|NCT03196349|Primary|Number of Subjects With Recurrent Venous Thromboembolism (VTE)|Primary efficacy outcome of recurrent VTE|Randomization to 12 months||||Participants|||Count of Participants
2535692|NCT03197025|Primary|Maximum Tolerated Dose (MTD) of E6 T Cell Receptor (TCR) T Cells for the Treatment of Vulvar High-Grade Squamous Intraepithelial Lesions (HSIL)|MTD is defined as the highest dose at which a maximum of 1 of 6 participants has a dose limiting toxicity (DLT). A DLT is defined as all treatment related Grade 3 (i.e. severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living (ADL)) and greater adverse events occurring within 30 days of the cell infusion with the exception of Grade 3 fever or chills responsive to symptomatic treatment that resolve to ≤ grade 2 in 48 hours. Grade 3 hypotension or oliguria responsive to ≤ 1.5L of intravenous fluid boluses in 24 hours that resolves to ≤ grade 2 in 48 hours. Grade 3 dyspnea/hypoxia that improves to ≤ grade 2 or less with supplemental oxygen and resolves to ≤ grade 2 without supplemental oxygen in 48 hours. Grade 3 creatinine or electrolyte abnormalities that resolve to ≤ grade 2 in 48 hours.|within 30 days of cell infusion||||cells|||Number
2535693|NCT03196635|Other Pre-specified|Radiation Dose for PA and TC Compressions|Radiation dose (entrance skin air kerma [ESAK] in milligray [mGy]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.|Through study completion, on average 1 month|ESAK was captured for each view under each compression for all subjects. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.|||mGy|Image Views|Standard Deviation|Mean
2535694|NCT03196635|Other Pre-specified|Breast Thickness for PA and TC Compressions|Breast thickness (millimeter [mm]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.|Through study completion, on average 1 month|Breast thickness (mm) was captured for each view under each compression for all subjects. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.|||mm|Image Views|Standard Deviation|Mean
2535695|NCT03196635|Other Pre-specified|Compression Force for PA and TC Compressions|Compression forces (decanewton [daN]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.|Through study completion, on average 1 month|Compression force (daN) was captured for each view under each compression for all subjects. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.|||daN|Image Views|Standard Deviation|Mean
2535696|NCT03196635|Other Pre-specified|Technologist Interventions in PA Compression|Data will be collected regarding any interventions made by the technologist during PA compression and this data were summarized.|Through study completion, on average 1 month|Subjects underwent PA compression on their assigned Breast of Interest. Technologists were asked to provide confirmation if any intervention was necessary while the subject was controlling the compression. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.|||Participants|||Count of Participants
2535697|NCT03196635|Other Pre-specified|Comparison of Image Acquisition Time|The length of time it takes for image acquisition using each compression mode (TC Compression and PA Compression) were compared.|Through study completion, on average 1 month|Imaging time was collected for each image set. 4 image sets were excluded from TC analysis due to repeat imaging per standard of care; repeat imaging wasn't allowed for PA compression. 1 subject’s PA & TC image sets were excluded from analysis due to a protocol deviation. 1 withdrawn subject did not undergo imaging, so was not part of the analysis.|||minutes||Standard Deviation|Mean
2535698|NCT03196635|Secondary|Acceptability of Mammographic Attributes|Acceptability of mammographic attributes using a binary response of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets were summarized.|Through study completion, on average 1 month|The PA and TC image sets for all 30 subjects were evaluated for acceptability of pre-defined set of mammography attributes by Readers 1 and 2. Adjudication was not required if there was disagreement between the readers. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.|||image sets|||Number
2535699|NCT03196635|Secondary|Repeat Image Acquisition|Number of incidences per image set when the technologists or readers indicated a repeat acquisition for PA and TC compression modes. More than one incident (i.e. reason for repeat from technologist or view indicated for repeat by readers) could have been selected for a given image set.|Through study completion, on average 1 month|Instances of repeat imaging for each subject's PA (N=30) and TC (N=30) image sets were indicated by technologists during image acquisitions and by readers during image evaluations. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.|||Image sets|Image sets||Count of Units
2535700|NCT03196635|Primary|Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets|One PA image set and one TC image set was acquired from each completed subject. The overall clinical image quality acceptability was collected and summarized on a per subject-basis using binary responses of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets. Two readers evaluated each of the 60 image sets (30 PA and 30 TC compression image sets from 30 completed participants). In cases of disagreement between Readers 1 and 2, a third reader provided adjudication.|Through study completion, on average 1 month|60 image sets (30 PA and 30 TC compression image sets from 30 participants) were evaluated for acceptability of overall clinical image quality by two readers. The one (1) withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.|||Participants|||Count of Participants
2535701|NCT03196349|Other Pre-specified|Number of Subjects Experiencing Vascular Events (Myocardial Infarction, Ischemic Stroke)|MI, ischemic stroke, peripheral arterial embolism|Randomization to 12 months||||Participants|||Count of Participants
2535702|NCT03196349|Other Pre-specified|Number of Subjects Experiencing All-cause Mortality|All cause mortality|Randomization to 12 months||||Participants|||Count of Participants
2535703|NCT03196349|Other Pre-specified|Number of Subjects With Premature Termination of Study Medication|Premature termination of study medication|Randomization to 12 months||||Participants|||Count of Participants
2535704|NCT03196349|Other Pre-specified|Number of Subjects Experiencing Clinically Relevant Non-major Bleeding|Clinically relevant non-major bleeding|Randomization to 12 months||||Participants|||Count of Participants
2535707|NCT03196349|Primary|Number of Subjects With Clinically Relevant Bleeding Events|Primary outcome of Clinically relevant bleeding (composite of major bleeding (MB) and/or clinically relevant non major bleeding (CRNMB))|Randomization to 12 months|44 subjects were randomized but analysis was only done on participants that had started therapy by the 1 month telephone visit|||Participants|||Count of Participants
2535708|NCT03195517|Secondary|Variation in Health-related Quality of Life (QoL).|Health-related Quality of Life evaluated using the Quality of Life questionnaire of the European Foundation for Osteoporosis (QUALEFFO). The score ranges from 0, corresponding to the best QoL, to 100, corresponding to the worst QoL. Total score is the average value of 5 sub scores, corresponding to pain, physical function, mental function, social function and general health perception.|Week 4 - Week 12||||score on a scale||Standard Deviation|Mean
2535709|NCT03195517|Secondary|Variation in Health-related Quality of Life (QoL)|Health-related Quality of Life evaluated using the Quality of Life questionnaire of the European Foundation for Osteoporosis (QUALEFFO). The score ranges from 0, corresponding to the best QoL, to 100, corresponding to the worst QoL. Total score is the average value of 5 sub scores, corresponding to pain, physical function, mental function, social function and general health perception.|Baseline - Week 4||||score on a scale||Standard Deviation|Mean
2535710|NCT03195517|Primary|Variation in Circulating Osteoprogenitor Cells (OPCs).|Measurements of circulating OPCs with stem cell characteristics (CD34+) and express bone-specific proteins such as alkaline phosphatase (AP +) and osteocalcin (OCN +).|Week 4 - Week 12||||cells/ml||Standard Deviation|Mean
2535711|NCT03195517|Primary|Variation in Circulating Osteoprogenitor Cells (OPCs)|Measurements of circulating OPCs with stem cell characteristics (CD34+) and express bone-specific proteins such as alkaline phosphatase (AP +) and osteocalcin (OCN +).|Baseline - Week 4||||cells/ml||Standard Deviation|Mean
2535712|NCT03195517|Primary|Variation of Serum Carboxy Terminal Telopeptide of Collagen Type I (sCTX)|Serum carboxy terminal telopeptide of collagen type I (sCTX) is one of the most sensitive and specific bone resorption markers of osteoclast-mediated collagen degradation.|Week 4 - Week 12||||ng/mL||Standard Deviation|Mean
2535713|NCT03195517|Primary|Variation in Serum Carboxy-terminal Telopeptide of Collagen Type I (sCTX)|Serum carboxy-terminal telopeptide of collagen type I (sCTX) is one of the most sensitive and specific bone resorption markers of osteoclast-mediated collagen degradation|Baseline - Week 4||||ng/mL||Standard Deviation|Mean
2535714|NCT03195517|Primary|Sclerostin|Sclerostin has been proposed as the check-point where PA acts to modulate bone metabolism.|Week 4 - Week 12|Post-menopausal women with low bone mass at DEXA measurement, compatible with osteopenia (T-score between -1 DS and -2.5 DS).|||pmol/L||Standard Deviation|Mean
2535715|NCT03195517|Primary|Serum Sclerotin Levels|Sclerostin has been proposed as the check-point where physical activity (PA) acts to modulate bone metabolism.|Baseline - W4|Post-menopausal women with low bone mass at DEXA measurement, compatible with osteopenia (T-score between -1 DS and -2.5 DS)|||pmol/L||Standard Deviation|Mean
2535716|NCT03195517|Primary|Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP).|P1NP is the most reliable serum marker of bone formation, commercially available at the moment.|Week 4 - Week 12|Post-menopausal women with low bone mass at DEXA measurement, compatible with osteopenia (T-score between -1 DS and -2.5 DS)|||mcg/L||Standard Deviation|Mean
2535717|NCT03195517|Primary|Variation in Serum Levels of Procollagen 1 N-terminal Peptide (P1NP)|P1NP is the most reliable serum marker of bone formation commercially available at the moment|Baseline - Week 4|Post-menopausal women with low bone mass at dual energy X-ray absorptiometry (DEXA) measurement, compatible with osteopenia (T-score between -1 DS and -2.5 DS)|||mcg/L||Standard Deviation|Mean
2535718|NCT03195010|Secondary|Progressive or New Venous Thromboembolic|Will evaluate the progressive or new venous thromboembolic. Will require imaging confirmation, defined as intraluminal filling defect(s) on contrast-enhanced computed tomography or incompressible venous segment(s) on ultrasonography.|Up to 1 year||||Participants|||Count of Participants
2535719|NCT03195010|Secondary|Progressive or New Arterial Thromboembolism|Will evaluate the progression or new arterial thromboembolism by either documented acute electrocardiographic changes compatible with myocardial injury and/or serum biochemical changes diagnostic of myocardial infarction, or documented imaging (computed tomography or magnetic resonance imaging) changes compatible with infarct due to embolism in the presence of a new neurological deficit, or imaging demonstrated intraluminal filling defects in an arterial distribution accompanied by symptoms of acute ischemia (acute onset pain, pallor, loss of pulses or other end-organ damage).|Up to 1 year||||Participants|||Count of Participants
2535720|NCT03195010|Secondary|Platelet Transfusion Related Complications|Total number of transfusion reactions, patients experiencing alloimmunization and volume overload will be reported.|Up to 1 year||||Platelet transfusion complication|||Number
2535721|NCT03195010|Secondary|Percent of Days on Which Subjects Are Transfused (or Transfusion Are Not Given)|The frequency with which transfusions are given despite a platelet count above the determined threshold will be documented, as will the frequency with which transfusions are not administered within 24 hours after a platelet count below the determined threshold.|Up to 1 year||||percentage of study days|||Number
2535722|NCT03195010|Secondary|Number of Platelet Transfusions Per Patient During the Study Period||Up to 1 year||||platelet transfusions||Full Range|Mean
2535723|NCT03195010|Secondary|Major Bleeds (World Health Organization Grade 3 or 4)|Will evaluate the major bleeds (World Health Organization grade 3 or 4).|Up to 1 year||||Participants|||Count of Participants
2535724|NCT03195010|Secondary|Incidence of Hemorrhagic Events (World Health Organization Grade 2 or Greater)|Will evaluate the incidence of hemorrhagic events (World Health Organization grade 2 or greater).|Up to 1 year||||Participants|||Count of Participants
2535725|NCT03195010|Primary|Number of Patients Successfully Following Protocol|Will evaluate the number of patients successfully following protocol, defined as receiving transfusions 'on protocol' at the end of the study period.|Up to 1 year||||Participants|||Count of Participants
2535726|NCT03195010|Primary|Number of Patients Screened and Deemed Ineligible|Reasons for ineligibility will be reported qualitatively in order to inform future studies.|Up to 1 year||||Participants|||Count of Participants
2535727|NCT03195010|Primary|Number of Patients Eligible||Up to 1 year||||Participants|||Count of Participants
2535728|NCT03195010|Primary|Number of Patients Consenting to Enrollment||Up to 1 year||||Participants|||Count of Participants
2535731|NCT03194776|Secondary|Change From Baseline in Pain-free Walking Distance (PFWD) as Assessed by 6-minute Walk Test at Week 16|PFWD was defined as the distance walked up to the point of onset of claudication symptoms (pain) recorded during the 6MWT and was used to evaluate symptomatic functional capacity of PAD participants. The PFWD was measured as the distance walked up to the time/place where the participant first experiences symptoms typical of their claudication which included pain, cramps, or other discomfort in the buttocks, thighs, calves or feet that occurs during the 6MWT exercise period.|Baseline, Week 16 (Day 113)|PD analysis set included all participants with available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||meters||80% Confidence Interval|Least Squares Mean
2535732|NCT03194776|Secondary|Time to Reach the Maximum Concentration After Drug Administration (Tmax)|Tmax is defined as the time to reach the maximum concentration after drug administration.|1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85|PK analysis set included all participants with at least one available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.|||Days||Full Range|Median
2535733|NCT03194776|Secondary|Observed Maximum Serum Concentration (Cmax) Following Drug Administration|Cmax is defined as the observed maximum serum concentration following drug administration.|1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85|PK analysis set included all participants with at least one available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.|||microgram per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2535734|NCT03194776|Secondary|Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)|AUCtau is defined as the area under the serum concentration-time curve from time zero to the end of the dosing interval tau.|1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85||||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2535735|NCT03194776|Secondary|Area Under the Serum Concentration-time Curve From Time Zero to Defined Time Point 't' (AUC[0-t])|AUC(0-t)is defined as the area under the serum concentration-time curve from time zero to time 't' where is a defined time point after administration.|1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85|PK analysis set included all participants with at least one available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.|||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2535736|NCT03194776|Secondary|Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)|AUClast is defined as the area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration.|1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose on Day 29 and 57; 0 hour predose and 1, 2 and 4 hours postdose on Day 85|Pharmacokinetic (PK) analysis set included all participants with at least one available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.|||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2535737|NCT03194776|Secondary|Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf)|AUCinf is defined as the area under the serum concentration-time curve from time zero to infinity.|1 hour predose and 1, 2 and 4 hours postdose on Day 1; 0 hour predose and 1, 2 and 4 hours postdose on Day 85|PK analysis set: Participants with at least 1 available valid PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data. N (overall number of participants analyzed) = participants evaluable for this outcome measure and 'n' (number analyzed) = participants evaluable at specified time points.|||day*microgram per millileter (day*mg/mL)||Geometric Coefficient of Variation|Geometric Mean
2535738|NCT03194776|Primary|Change From Baseline in Maximum Walking Distance (MWD) as Assessed by 6-minute Walk Test (6MWT) at Week 16|MWD was assessed by the 6MWT prior to dosing was used to evaluate functional capacity of peripheral artery disease (PAD) participants. 6MWT test included measurement of total distance walked in 6 minutes.|Baseline, Week 16 (Day 113)|Pharmacodynamic (PD) analysis set included all participants with available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this endpoint.|||meter (m)||80% Confidence Interval|Least Squares Mean
2535739|NCT03194776|Primary|Number of Participants With Adverse Events (AEs), Drug-related AEs, Serious Adverse Events (SAEs) and Deaths|An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign, including abnormal laboratory findings, symptom or disease) in a participant after providing written informed consent for participation in the study until the end of study visit. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product. An SAE is defined as any AE which is is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect in offspring, requires inpatient hospitalization or prolongation of existing hospitalization and is is medically significant.|Up to 32 Weeks|Safety analysis set included all participants that received any study treatment.|||Participants|||Count of Participants
2535740|NCT03194698|Secondary|Change in Meibomian Glands Open - Left Lower Lid|The count of manual expression of the meibomian glands. A thumb is placed against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.|3 months||||percentage of blocked meibomian||Standard Deviation|Mean
2535741|NCT03194698|Secondary|Change in Meibomian Glands Open - Right Lower Lid|The count of manual expression of the meibomian glands. A thumb is placed against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.|baseline, 3 months||||percentage of blocked meibomian pores||Standard Deviation|Mean
2536693|NCT03159299|Secondary|Body Mass Index (BMI)|A calibrated electronic scale will be used to record weight and a wall-based stadiometer will be used to record height. Weight and height will be combined to report BMI in kg/m^2.|Baseline|||||||
2535742|NCT03194698|Primary|Change in Ocular Surface Disease Index (OSDI) Symptom Survey Score|"Symptom survey on severity of dry eye symptoms. This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to none of the time and 4 corresponding to all of the time. A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease."|baseline, 3 months||||percentage of change in OSDI score||Standard Deviation|Mean
2535743|NCT03194490|Secondary|Pressure Pain Threshold|Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four and eight.|Pressure Pain Threshold score at week eight||||pound per centimeter square||Standard Error|Mean
2535744|NCT03194490|Secondary|Pressure Pain Threshold|Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four and eight.|Pressure Pain Threshold score at week four||||pound per centimeter square||Standard Error|Mean
2535745|NCT03194490|Secondary|Pressure Pain Threshold|Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four and eight.|Pressure Pain Threshold score at week two||||pound per centimeter square||Standard Error|Mean
2535746|NCT03194490|Secondary|Pressure Pain Threshold|Pressure pain threshold is an electronic device used to measure the amount of force that is required to produce pain when comparing baseline, week two, four, and eight.|Pressure Pain Threshold score at baseline||||pound per centimeter square||Standard Error|Mean
2535747|NCT03194490|Secondary|Global Rating of Change|The Global rating of change (GROC) is used to measure the amount of improvement that the patient achieves from the intervention or rehabilitation program when comparing baseline, week two, four and right. The score ranges from -7 to 0 to 7 in which -/+3 to -/+ 1 represents a small change, -/+ 4 to -/+5 represents moderate change and -/+6 to -/+7 means a large change. The negative and positive means the patient condition worsens or improves respectively.|GROC score at week eight||||points||Standard Error|Mean
2535748|NCT03194490|Secondary|Global Rating of Change|The Global rating of change (GROC) is used to measure the amount of improvement that the patient achieves from the intervention or rehabilitation program when comparing baseline, week two, four and eight. The score ranges from -7 to 0 to 7 in which -/+3 to -/+ 1 represents a small change, -/+ 4 to -/+5 represents moderate change and -/+6 to -/+7 means a large change. The negative and positive means the patient condition worsens or improves respectively.|GROC score at week four||||points||Standard Error|Mean
2535749|NCT03194490|Secondary|Global Rating of Change|The Global rating of change (GROC) is used to measure the amount of improvement that the patient achieves from the intervention or rehabilitation program when comparing baseline, week two, four, and eight. The score ranges from -7 to 0 to 7 in which -/+3 to -/+ 1 represents a small change, -/+ 4 to -/+5 represents moderate change and -/+6 to -/+7 means a large change. The negative and positive means the patient condition worsens or improves respectively. The points are scores on a scale (-7-0-+7 = 15 point scale).|GROC score at week two||||points||Standard Error|Mean
2535750|NCT03194490|Secondary|Neck Disability Index|Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight. It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50. A score of zero (0) represents no disability while a score of 50 represents severe, full disability.|NDI score at week eight||||points||Standard Error|Mean
2535751|NCT03194490|Secondary|Neck Disability Index|Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight. It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50. A score of zero (0) represents no disability while a score of 50 represents severe, full disability.|NDI score at week four||||points||Standard Error|Mean
2535752|NCT03194490|Secondary|Neck Disability Index|Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight. It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50. A score of zero (0) represents no disability while a score of 50 represents severe, full disability.|NDI score at week two||||points||Standard Error|Mean
2535753|NCT03194490|Secondary|Neck Disability Index|Neck disability index measuring the level of neck disability when comparing baseline, week two, four, and eight. It consists of ten items each item is scored from 0 to 5 with a minimum score 0 and highest score 50. A score of zero (0) represents no disability while a score of 50 represents severe, full disability.|NDI score at baseline||||points||Standard Error|Mean
2535754|NCT03194490|Secondary|Numeric Pain Rating Scale|Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight. It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals. The zero represents no pain while a 10 represents very severe pain that participant cannot stand.|NPRS score at week eight||||Cm||Standard Error|Mean
2535755|NCT03194490|Secondary|Numeric Pain Rating Scale|Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight. It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals. The zero represents no pain while a 10 represents very severe pain that participant cannot stand.|NPRS score at week four||||Cm||Standard Error|Mean
2535756|NCT03194490|Secondary|Numeric Pain Rating Scale|Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight. It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals. The zero represents no pain while a 10 represents very severe pain that participant cannot stand.|NPRS score at week two||||Cm||Standard Error|Mean
2535757|NCT03194490|Secondary|Numeric Pain Rating Scale|Numeric pain rating scale (NPRS) is a liner outcome measurement used to determine the level of the participant's pain when comparing baseline, week two, four and eight. It consists of a straight 10 cm line that is scored from 0 to 10 with 10 mm intervals. The zero represents no pain while a 10 represents very severe pain that participant cannot stand. The standard error is correct as stated.|NPRS score at baseline||||Cm||Standard Error|Mean
2535759|NCT03194490|Primary|Cervical Range of Motion|The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline, week two, four and eight.|Participants measurement at week four||||Degree||Standard Error|Mean
2535760|NCT03194490|Primary|Cervical Range of Motion|The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline, week two, four and eight.|Participants ROM measurement at week 2||||Degree||Standard Error|Mean
2535761|NCT03194490|Primary|Cervical Range of Motion|The cervical range of motion device (CROM) will be used to assess the changes in active range of motion for cervical rotation, flexion and extension when comparing baseline,week two, four and eight.|Participants ROM measurement at baselines||||Degree||Standard Error|Mean
2535762|NCT03194373|Secondary|Overall Survival Time||Up to 2 Years|||||||
2535763|NCT03194373|Secondary|Progression Free Survival Time|Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression. Progressive disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.|Up to 2 Years|||||||
2535764|NCT03194373|Primary|Percent Disease Control Rate (DCR)|The primary clinical objective of this trial is to estimate disease control rate (DCR) at 12 weeks in patients with metastatic head and neck squamous cell cancer treated with carboplatin and palbociclib. DCR will be defined as either CR (Complete Response: Disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.), PR (Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.) or SD (Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.) at 12 weeks.|12 weeks|Patients were considered evaluable for response if they underwent response evaluation imaging after 2 cycles of receiving both carboplatin and palbociclib.|||percentage of participants||95% Confidence Interval|Number
2535765|NCT03194334|Secondary|Capillary pH|capillary pH at the start and at the end of the incremental cycling test performed at 0, 3 and 6 months|6 months||||pH||Standard Deviation|Mean
2535766|NCT03194334|Secondary|Capillary Lactate|capillary lactate at the start and at the end of the incremental cycling test performed at 0, 3 and 6 months|6 months||||mmol/L||Standard Deviation|Mean
2535767|NCT03194334|Secondary|Time to Exhaustion|Time to exhaustion during incremental cycling test performed at 0, 3 and 6 months|6 months||||minutes||Standard Deviation|Mean
2535768|NCT03194334|Secondary|VO2max|VO2max during incremental cycling test performed at 0, 3 and 6 months|6 months||||ml/min/kg||Standard Deviation|Mean
2535769|NCT03194334|Secondary|Urinary Biomarker for Meat Intake: Anserine|urinary anserine concentration at 0, 3 and 6 months of the intervention|6 months||||mg/24h||Standard Deviation|Mean
2535770|NCT03194334|Secondary|Urinary Biomarker for Meat Intake: Tau-methyl-histidine|urinary tau-methyl-histidine concentration at 0, 3 and 6 months of the intervention|6 months||||mg/24h||Standard Deviation|Mean
2535771|NCT03194334|Secondary|Urinary Biomarker for Meat Intake: Pi-methyl-histidine|urinary pi-methyl-histidine concentration at 0, 3 and 6 months of the intervention|6 months||||mg/24h||Standard Deviation|Mean
2535772|NCT03194334|Secondary|Vitamin D Status|Serum 25-Hydroxyvitamin D concentration at 0, 3 and 6 months of the intervention|6 months||||ng/ml||Standard Deviation|Mean
2535773|NCT03194334|Primary|Muscle Total Carnitine Concentration|muscle total carnitine concentration (free + acetylcarnitine) in vastus lateralis muscle at 0 and 3 months of the intervention|3 months||||mmol/kg dry weight||Standard Deviation|Mean
2535774|NCT03194334|Primary|Muscle Acetylcarnitine Concentration|muscle acetylcarnitine concentration in vastus lateralis muscle at 0 and 3 months of the intervention|3 months||||mmol/kg dry weight||Standard Deviation|Mean
2535775|NCT03194334|Primary|Muscle Carnitine Concentration|muscle free carnitine concentration in vastus lateralis muscle at 0 and 3 months of the intervention|3 months||||mmol/kg dry weight||Standard Deviation|Mean
2535776|NCT03194334|Primary|Plasma Total Carnitine Concentration|plasma total carnitine concentration (free + acetyl) at 0, 3 and 6 months of the intervention|6 months||||µmol/L||Standard Deviation|Mean
2535777|NCT03194334|Primary|Plasma Acetylcarnitine Concentration|plasma acetylcarnitine concentration at 0, 3 and 6 months of the intervention|6 months||||µmol/L||Standard Deviation|Mean
2535778|NCT03194334|Primary|Plasma Carnitine Concentration|plasma free carnitine concentration at 0, 3 and 6 months of the intervention|6 months||||µmol/L||Standard Deviation|Mean
2535779|NCT03194334|Primary|Muscle Creatine Concentration|Muscle total creatine concentration in vastus lateralis muscle at 0 and 3 months of the intervention|3 months||||mmol/kg||Standard Deviation|Mean
2535780|NCT03194334|Primary|Urinary Creatinine Concentration|Urinary creatinine at 0, 3 and 6 months of the intervention|6 months||||mg/24h||Standard Deviation|Mean
2535781|NCT03194334|Primary|Plasma Guanidinoacetate Concentration|Plasma guanidinoacetate at 0, 3 and 6 months of the intervention|6 months||||µmol/L||Standard Deviation|Mean
2535782|NCT03194334|Primary|Plasma Creatinine Concentration|Plasma creatinine at 0, 3 and 6 months of the intervention|6 months||||µmol/L||Standard Deviation|Mean
2535783|NCT03194334|Primary|Plasma Creatine Concentration|Plasma creatine concentration at 0, 3 and 6 months of the intervention|6 months||||µmol/L||Standard Deviation|Mean
2535784|NCT03194334|Primary|Soleus Carnosine Concentration|Soleus carnosine concentration at 0, 3 and 6 months of the intervention|6 months||||mM||Standard Deviation|Mean
2535785|NCT03194334|Primary|Gastrocnemius Carnosine Concentration|Gastrocnemius carnosine concentration at 0, 3 and 6 months of the intervention|6 months||||mM||Standard Deviation|Mean
2535786|NCT03194334|Primary|Fasted Plasma Beta-alanine Concentration|Fasted venous plasma beta-alanine concentration (precursor for carnosine) at 0, 3 and 6 months of the intervention|6 months||||µM||Standard Deviation|Mean
2535800|NCT03193021|Secondary|Time to Hemostasis (TTH)|Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and first observed and confirmed venous hemostasis, for each access site.|Post-procedure, usually within 3 hours||||minutes||Standard Deviation|Mean
2535787|NCT03193593|Primary|Subject's Assessment of Pain Using the Numeric Pain Rating Scale (AUC16h-96h)|Subject's assessment of pain using the Numeric Pain Rating Scale (1= No Pain, 10= Maximum Pain) for the first 96 hours following injection, expressed as AUC over the 16h to 96h period following dosing.|16 hours to 96 hours following dosing|mITT|||units on a Scale*hours||Standard Deviation|Mean
2535788|NCT03193047|Secondary|Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2|The number of participants with ALT or AST >3x ULN was measured.|Month 1 and Month 2|Safety Population. Only those participants with available data were analyzed.|||Participants|||Count of Participants
2535789|NCT03193047|Secondary|Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE)|Treatment-emergent AEs (TEAEs) and SAEs (TESAEs) were reported and defined as any AE that began or worsened after the first dose of investigational medicinal product.|up to Month 2 (until 30 days after last dose)|Safety Population: all randomized participants who received at least 1 dose of IMP. Participants in the Safety Population were included in the treatment group that they received, regardless of their randomized treatment.|||Participants|||Count of Participants
2535790|NCT03193047|Secondary|Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Month 1 and Month 2|Percent change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the Day 1 value. Percent change from Baseline was analyzed using a non-parametric approach. Missing Month 2 data were handled by LOCF. Observed data were used for analysis at Month 1.|Baseline; Month 1 and Month 2|Modified Intent-to-Treat Population. Only those participants with data available were analyzed.|||percent change||Inter-Quartile Range|Median
2535791|NCT03193047|Secondary|Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2|Percent change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline apolipoprotein B (apoB) is defined as the Day 1 value. Baseline total cholesterol (TC) and non-high-density lipoprotein cholesterol (non-HDL-C) are defined as the average of the Month -1 (Screening Visit 4) and the Day 1 (Treatment Visit 1) values. If a missing value presented at Month -1 or Day 1, then the last non-missing value prior to the first dose of double-blind study medication (including unscheduled assessments) within Month -1 and Day 1 was used to compute the Baseline measurements. Percent change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate. Observed data were used for analysis at Month 1. Missing Month 2 data were handled by LOCF.|Baseline; Month 1 and Month 2|mITT Population|||percent change||Standard Error|Least Squares Mean
2535792|NCT03193047|Secondary|Absolute Change From Baseline in LDL-C at Month 1 and Month 2|Change from Baseline is calculated as the post-Baseline value minus the Baseline value. Baseline is defined as the average of the Screening Visit 4 and the Day 1 value. If only 1 value is available, then that single value is used as Baseline. Change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate. Observed data were used for analysis at Month 1. Missing Month 2 data were handled by LOCF.|Baseline; Month 1 and Month 2|Modified Intent-to-Treat Population. Only those participants with data available were analyzed.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2535793|NCT03193047|Secondary|Percent Change From Baseline in LDL-C at Month 1|Percent change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the average of the last two non-missing values within Month -1 (Screening Visit 4) and Day 1 (Treatment Visit 1) values (including unscheduled assessments). If only one value was available, then that single value was used at Baseline. Percent change from Baseline was analyzed using ANCOVA, with treatment group as a factor and Baseline as a covariate. Observed data were used for analysis.|Baseline; Month 1|Modified Intent-to-Treat Population. Only those participants with data available were analyzed.|||percent change||Standard Error|Least Squares Mean
2535794|NCT03193047|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Month 2|Percent change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the average of the last two non-missing values within Month -1 (Screening Visit 4) and Day 1 (Treatment Visit 1) values (including unscheduled assessments). If only one value was available, then that single value was used at Baseline. Percent change from Baseline was analyzed using analysis of covariance (ANCOVA), with treatment group as a factor and Baseline as a covariate. Missing data were imputed using last observation carried forward (LOCF) (only post-Baseline values were carried forward).|Baseline; Month 2|Modified Intent-to-Treat (mITT) Population: all randomized participants with a Baseline lipid value and at least 1 post-Baseline lipid value who received investigational medicinal product (IMP) within 2 days before the lipid measurement and evolocumab 420 mg within 30 days plus or minus 3 days before the lipid measurement|||percent change||Standard Error|Least Squares Mean
2535795|NCT03193021|Secondary|Device Success|Ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Mid-Bore VVCS (per access site analysis, treatment arm only)|Procedural, usually within 15 minutes of enrollment|Number of access sites where device insertion was attempted.|||Successful Femoral Access Sites|Femoral Access Sites||Number
2535796|NCT03193021|Secondary|Procedure Success|Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications|30 +/- 7 days post-procedure||||Participants|||Count of Participants
2535797|NCT03193021|Secondary|Total Post-Procedure Time (TPPT)|Elapsed time between removal of the last procedural device for the index procedure and when the subject is able to successfully ambulate|Post-procedure, usually within 6 hours||||hours||Standard Deviation|Mean
2535798|NCT03193021|Secondary|Time to Closure Eligibility (TTCE)|Elapsed time between removal of the last procedural device for the index procedure and removal of the first Mid-Bore VVCS device (treatment arm) or removal of first sheath (control arm)|Post-procedure, usually within 6 hours||||minutes||Standard Deviation|Mean
2535799|NCT03193021|Secondary|Time to Discharge (TTD)|Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject is discharged|Prior to hospital discharge, usually within 24 hours||||hours||Standard Deviation|Mean
2536694|NCT03159299|Secondary|Change in Baseline Systolic and Diastolic Blood Pressure From Baseline|Systolic and diastolic BP will be measured according to practice standards. Two readings separated by 1 minute will be averaged|6 months|||||||
2535801|NCT03193021|Secondary|Time to Discharge Eligibility (TTDE)|Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject is eligible for discharge based solely on assessment of the access site|Prior to hospital discharge, usually within 24 hours||||hours||Standard Deviation|Mean
2535802|NCT03193021|Secondary|Minor Venous Access Site Closure-related Complications|Rate of combined minor venous access site closure-related complications attributed directly to the closure method.|30 +/- 7 days post-procedure|Combined Venous Access Site Closure-Related Complications, As Reported, Number of Limbs with Each Event|||minor complications|Number of Limbs||Number
2535803|NCT03193021|Primary|Major Venous Access Site Closure-related Complications|Rate of combined major venous access site closure-related complications attributed directly to the closure method.|30 +/- 7 days post-procedure|Major Venous Access Site Closure-Related Complications, Number of Limbs with Each Event|||major complications|Number of Limbs|95% Confidence Interval|Number
2535804|NCT03193021|Primary|Time to Ambulation (TTA)|Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject stands and walks 20 feet without evidence of venous re-bleeding from the femoral access site.|Post-procedure, usually within 6 hours||||hours||Standard Deviation|Mean
2535805|NCT03192826|Primary|Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy|Comparison of intraocular pressure at 1 week after Nd-YAG posterior capsulotomy compared to Baseline IOP|1 week|Comparison of intraocular pressure at 1 weekafter Nd-YAG posterior capsulotomy compared to Baseline IOP|||mmHg||Standard Deviation|Mean
2535806|NCT03192826|Primary|Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy|Comparison of intraocular pressure at 24 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP|24 hours|Comparison of intraocular pressure at 24 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP|||mmHg||Standard Deviation|Mean
2535807|NCT03192826|Primary|Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy|Comparison of intraocular pressure at 3 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP|3 hours|Comparison of intraocular pressure at 3 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP|||mmHg||Standard Deviation|Mean
2535808|NCT03192826|Primary|Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy|Comparison of intraocular pressure at 1 hour after Nd-YAG posterior capsulotomy compared to Baseline IOP|1 hour|Comparison of intraocular pressure at 1 hour after Nd-YAG posterior capsulotomy compared to Baseline IOP|||mmHg||Standard Deviation|Mean
2535809|NCT03192475|Secondary|Change in Mood|Center for Epidemiological Studies Depression Scale (CES-D) (score ranges 0-60; higher score indicates greater depressive symptoms)|change from baseline score at 12-months|162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 155 (95.7%) of GLB plus phone contacts and 155 (96.9%) of GLB plus newsletter contacts were included in the analysis of change in health-related quality of life at 12 months.|||score on a scale||Standard Deviation|Mean
2535810|NCT03192475|Secondary|Change in Nutrition|Mediterranean Diet Assessment Tool. Total score ranges from 0 - 14. A higher score means higher adherence to a better quality of diet.|change from baseline score at 12-months|162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in Mediterranean Diet score at 12 months.|||score on a scale||Full Range|Mean
2535811|NCT03192475|Secondary|Change in Health Related Quality of Life-physical Component Summary Score|Short-form 12-item health status questionnaire produces two scores: a physical component summary score and a mental component summary score. Scores range from 0-100 with higher scores indicating better health related quality of life. Each component score is transformed (standardized) using a mean of 50 and a standard deviation of 10.|Change from baseline score at 12-months|162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in health-related quality of life at 12 months.|||score on a scale||Standard Deviation|Mean
2535812|NCT03192475|Secondary|Percentage Participants Achieving 3 or More Days of Moderate Intensity Physical Activities Per Week|"Stanford Brief Physical Activity categorical measure:~Queries amount and intensity of typical weekly activities over the past month.~most of week spent without any physical activity; sedentary at home; light chores; high intensity activities no more than 1-2 times per month.~most days of week spent doing few activities; 1-2 times per week some light-moderate activity like walking or active chores at home.~at least 3 times per week reports moderate activity such as brisk walking for 15-20 minutes or more, or at least 45-60 minutes of heavy home and yard chores.~at least 3 times per week reports a regular program of moderate-vigorous intensity physical activities, or a regular program of fitness for 30 minutes or more, or active games like handball or tennis, or heavy home and yard chores for 60-minutes or more.~Participants that endorse items 3 or 4 were considered to have achieved 3 or more days of moderate intensity physical activities per week."|percentage reporting higher intensity level activities 3 times per week or more at 12 months|162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these, 155 (95.7%%) GLB plus phone contacts and 156 (97.5%) GLB plus newsletter contacts were included in analysis of percentage reporting higher intensity activities 3 times per week or more.|||Participants|||Count of Participants
2535813|NCT03192475|Secondary|Change in Physical Activity Minutes/Week Using All CHAMPS Items|Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity questionnaire for older adults|Change from baseline minutes/week at 12-months|162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 155 (95.7%%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in physical activity minutes /per week at 12 months.|||minutes/week||Inter-Quartile Range|Median
2536130|NCT03180619|Primary|Percentage of Participants Achieving Virologic Response (Plasma Hepatitis B Virus [HBV] Deoxyribonucleic Acid [DNA] < 20 IU/mL) at Week 24|The percentage of participants with HBV DNA < 20 IU/mL at Week 24 was determined by the Missing = Failure (M = F) approach.|Week 24|The Full Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2535814|NCT03192475|Secondary|Change in Physical Function Performance Battery|"Short Physical Performance Battery (SPPB) total score (0-12) includes three function tests (each scored 0-4) and summed.~The subtests are (1) gait speed measured in meters/second on a 4-meter walk route; (2) 3 progressive standing balance tests; (3) 5 chair stands. Higher score indicates better physical function."|Change from baseline score at 12-months|162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in the physical function performance battery at 12 months.|||score on a scale||Standard Deviation|Mean
2535815|NCT03192475|Secondary|Change in Diastolic Blood Pressure (mmHg)|Diastolic blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMROM HEM90HXC)|Change from baseline value at 12 months|162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in diastolic blood pressure at 12 months.|||mm/Hg||95% Confidence Interval|Mean
2535816|NCT03192475|Secondary|Change in Systolic Blood Pressure|Systolic blood pressure (mmHg) measured by arm cuff digital blood pressure monitor (OMROM HEM90HXC)|Change from baseline level at 12-months|162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in systolic blood pressure at 12 months.|||mmHg||95% Confidence Interval|Mean
2535817|NCT03192475|Secondary|Change in Fasting Glucose|Fasting glucose (mg/dl) measured by finger-stick sample|Change from baseline level at 12-months|162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in fasting glucose at 12 months.|||mg/dl||95% Confidence Interval|Mean
2535818|NCT03192475|Secondary|Change in Fasting Triglycerides|Triglycerides (mg/dl) measured by fasting finger-stick sample|Change from baseline level at 12-months|162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in fasting triglycerides at 12 months.|||mg/dl||95% Confidence Interval|Mean
2535819|NCT03192475|Secondary|Change in Fasting Low-Density Lipoprotein (LDL) Cholesterol|LDL-cholesterol (mg/dl) measured by finger-stick blood sample|Change from baseline level at 12-months|162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in fasting Low-Density Lipoprotein (LDL) at 12 months.|||mg/dl||95% Confidence Interval|Mean
2535820|NCT03192475|Secondary|Change in Fasting High-Density Lipoprotein (HDL) Cholesterol|HDL-cholesterol (mg/dl) measured by finger-stick blood sample|Change from baseline level at 12-months|162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these, 156 (96.3%) GLB plus phone contacts and 156 (97.5%) GLB plus newsletter contacts were included in the analysis of change in fasting high-density lipoprotein cholesterol at 12 months.|||mg/dl||95% Confidence Interval|Mean
2535821|NCT03192475|Secondary|Change in Fasting Total Cholesterol|Total cholesterol (mg/dl) measured by finger-stick blood sample|Change from baseline level at 12-months|162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in fasting total cholesterol at 12 months.|||mg/dl||95% Confidence Interval|Mean
2535822|NCT03192475|Secondary|Change in Waist Circumference|Waist circumference measured with a spring-loaded tape measure.|Change from baseline circumference at 12-months|162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the 12 month analysis of change in waist circumference.|||cm||95% Confidence Interval|Mean
2535823|NCT03192475|Primary|Change in Bodyweight|Bodyweight of participant.|Change from baseline bodyweight at 12-months|162 participants were randomized to Group Lifestyle Balance (GLB) plus phone contacts and 160 were randomized to GLB plus newsletter contacts at 4 months. Of these 156 (96.3%) of GLB plus phone contacts and 156 (97.5%) of GLB plus newsletter contacts were included in the analysis of change in bodyweight at 12 months.|||percent weight change||95% Confidence Interval|Mean
2535824|NCT03192306|Secondary|Subject Assessed Duration of Pain|Time of first occurrence of at least mild pain to consistent scoring of no pain|From time of first occurrence of at least mild pain to time of consistent scoring of no pain - maximum 14 days|Subjects with cold sore lesions pain assessment. One subject in the Merlin cohort was lost to follow-up, did not complete the study and was therefore excluded from this analysis.|||Participants|||Count of Participants
2535825|NCT03192306|Secondary|Clinician Assessed Duration of the Herpetic Lesion Hard Scab|Duration of the hard crust (Stage 5)|From start of Stage 5 to loss of hard crust - maximum of 14 days|Only those subjects who developed a cold sore with a hard scab (Stage 5) were analyzed for this endpoint.|||hours||Standard Deviation|Mean
2535826|NCT03192306|Secondary|Clinician Assessed Lesion Size|Maximum lesion area for ulcerative lesions during Stages 3-5|14 days maximum|Subjects who developed a classical herpetic lesion during the course of the trial.|||square mm||Standard Deviation|Mean
2535827|NCT03192306|Secondary|Clinician Assessed Prevention of Progression to Classical Lesion|Proportion of subjects in each treatment group who do not display classical lesions|14 days maximum|Subjects who developed a cold sore lesion and treated during the course of the trial. One subject in the Merlin cohort was lost to follow-up, did not complete the study and was therefore excluded from this analysis.|||Participants|||Count of Participants
2536141|NCT03180489|Primary|Change From Baseline in Satiety Hormone Insulin at Week 12|Will be analyzed using a commercially available biochemical assay.|Data not collected|Data not collected||||||
2535828|NCT03192306|Secondary|Clinician Assessed Duration Until Complete Healing of the Herpetic Episode|The time, in hours, from the beginning of treatment to onset of Stage 7|From the beginning of treatment to onset of Stage 7 - maximum of 14 days|Subjects who developed a cold sore and treated during the course of the trial. One subject in the Merlin cohort was lost to follow-up, did not complete the study and was therefore excluded from this analysis.|||hours||Standard Deviation|Mean
2535829|NCT03192306|Secondary|Clinician Assessed Duration of the Herpetic Episode|For classical lesions: the time in hours from the beginning of the treatment until loss of hard crust (Stage 6); for non-classical lesions the time from the beginning of treatment until complete resolution of all local signs and symptoms (Stage 7)|For classical lesions: from the beginning of the treatment until loss of hard crust (Stage 6); for non-classical lesions the time from the beginning of treatment until complete resolution of all local signs and symptoms (Stage 7) - maximum of 14 days|Subjects who developed a cold sore lesion and treated during the course of the trial. One subject in the Merlin cohort was lost to follow-up, did not complete the study and was therefore excluded from this analysis.|||hours||Standard Deviation|Mean
2535830|NCT03192306|Primary|Clinician Assessed Duration of the Classical Herpetic Lesion|The time in hours from beginning of treatment to onset of Stage 6 (residual swelling) or Stage 7 (complete healing) if Stage 6 never observed|From time of beginning of treatment until onset of Lesion Stage 6 or Stage 7, if Stage 6 never observed, with a maximum of 14 days.|Only those subjects who developed a classical cold sore lesion, i.e. exhibited Stages 3, 4 or 5, during the course of the trial and treated were analyzed for this endpoint.|||hours||Standard Deviation|Mean
2535831|NCT03191552|Secondary|Parent Satisfaction Questionnaire Total Score|"A non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below:~Parent satisfaction survey~SPIO vest was easy to put on/off.~Child was comfartable during times the SPIO was worn.~Child's sitting balance improved.~Caring of the garment (cleaning vs) was easy.~Child's confidence was improved.~No problems about touletting occured.~I wish to attend this therapy programme again.~I consider attending this therapy programme in the future again.~I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45)."|3 months||||units on a scale||Standard Deviation|Mean
2535832|NCT03191552|Secondary|Parent Satisfaction Questionnaire Total Score|"A non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below:~Parent satisfaction survey~SPIO vest was easy to put on/off.~Child was comfartable during times the SPIO was worn.~Child's sitting balance improved.~Caring of the garment (cleaning vs) was easy.~Child's confidence was improved.~No problems about touletting occured.~I wish to attend this therapy programme again.~I consider attending this therapy programme in the future again.~I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45)."|1 month||||units on a scale||Standard Deviation|Mean
2535833|NCT03191552|Secondary|Parent Satisfaction Questionnaire Total Score|"A non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below:~Parent satisfaction survey~SPIO vest was easy to put on/off.~Child was comfartable during times the SPIO was worn.~Child's sitting balance improved.~Caring of the garment (cleaning vs) was easy.~Child's confidence was improved.~No problems about touletting occured.~I wish to attend this therapy programme again.~I consider attending this therapy programme in the future again.~I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45)."|2 weeks||||units on a scale||Standard Deviation|Mean
2535834|NCT03191552|Secondary|Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7)|"A non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below:~Parent satisfaction survey~SPIO vest was easy to put on/off.~Child was comfartable during times the SPIO was worn.~Child's sitting balance improved.~Caring of the garment (cleaning vs) was easy.~Child's confidence was improved.~No problems about touletting occured.~I wish to attend this therapy programme again.~I consider attending this therapy programme in the future again.~I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45)."|3 months||||units on a scale||Standard Deviation|Mean
2535835|NCT03191552|Secondary|Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7)|"A non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below:~Parent satisfaction survey~SPIO vest was easy to put on/off.~Child was comfartable during times the SPIO was worn.~Child's sitting balance improved.~Caring of the garment (cleaning vs) was easy.~Child's confidence was improved.~No problems about touletting occured.~I wish to attend this therapy programme again.~I consider attending this therapy programme in the future again.~I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45)."|1 month||||units on a scale||Standard Deviation|Mean
2536142|NCT03180489|Primary|Change From Baseline in Satiety Hormone Leptin at Week 12|Will be analyzed using a commercially available biochemical assay.|Data not collected|Data not collected||||||
2536143|NCT03180489|Primary|Change From Baseline in Maker of Oxidative Stress (Low Density Thiobarbituric Acid Reactive Substances) at Week 12|Will be analyzed using a commercially available biochemical assay.|Data not collected|Data not collected||||||
2535836|NCT03191552|Secondary|Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7)|"A non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below:~Parent satisfaction survey~SPIO vest was easy to put on/off.~Child was comfartable during times the SPIO was worn.~Child's sitting balance improved.~Caring of the garment (cleaning vs) was easy.~Child's confidence was improved.~No problems about touletting occured.~I wish to attend this therapy programme again.~I consider attending this therapy programme in the future again.~I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45)."|2 weeks||||units on a scale||Standard Deviation|Mean
2535837|NCT03191552|Secondary|Box and Block Test (BBT)|Evaluates gross manuel dexterity. Box and Block Test which consists of a box divided into two compartments by a partition and blocks with standardized dimensions is used to assess unilateral gross manuel dexterity. The object is instructed to transport boxes one by one from one compertmant of the box to other in 60 seconds. The object should sit on a chair with a standard height and face the box. He/she should practice for a 15 second trial period before testing. If two blocks are carried at the same time, it is counted as one. And also if the block falls on the floor after it has been carried across, it is still counted. The score is the number of boxes transferred from one compartment to other in 60 seconds.|3 months||||units on a scale||Standard Deviation|Mean
2535838|NCT03191552|Secondary|Box and Block Test (BBT)|Evaluates gross manuel dexterity. Box and Block Test which consists of a box divided into two compartments by a partition and blocks with standardized dimensions is used to assess unilateral gross manuel dexterity. The object is instructed to transport boxes one by one from one compertmant of the box to other in 60 seconds. The object should sit on a chair with a standard height and face the box. He/she should practice for a 15 second trial period before testing. If two blocks are carried at the same time, it is counted as one. And also if the block falls on the floor after it has been carried across, it is still counted. The score is the number of boxes transferred from one compartment to other in 60 seconds.|1 month||||units on a scale||Standard Deviation|Mean
2535839|NCT03191552|Secondary|Box and Block Test (BBT)|Evaluates gross manuel dexterity. Box and Block Test which consists of a box divided into two compartments by a partition and blocks with standardized dimensions is used to assess unilateral gross manuel dexterity. The object is instructed to transport boxes one by one from one compertmant of the box to other in 60 seconds. The object should sit on a chair with a standard height and face the box. He/she should practice for a 15 second trial period before testing. If two blocks are carried at the same time, it is counted as one. And also if the block falls on the floor after it has been carried across, it is still counted. The score is the number of boxes transferred from one compartment to other in 60 seconds.|2 weeks||||units on a scale||Standard Deviation|Mean
2535840|NCT03191552|Secondary|Box and Block Test (BBT)|Evaluates gross manuel dexterity. Box and Block Test which consists of a box divided into two compartments by a partition and blocks with standardized dimensions is used to assess unilateral gross manuel dexterity. The object is instructed to transport boxes one by one from one compertmant of the box to other in 60 seconds. The object should sit on a chair with a standard height and face the box. He/she should practice for a 15 second trial period before testing. If two blocks are carried at the same time, it is counted as one. And also if the block falls on the floor after it has been carried across, it is still counted. The score is the number of boxes transferred from one compartment to other in 60 seconds.|Immediate after orthosis is worn|The immediate effect of orthosis could only be evaluated in SPIO groups because the orthosis is tailor made and only children in SPIO groups had the orthosis. Given that the number of the objects in each SPIO group is 8, immediate effect of the orthosis could only be evaluated in children recruited in SPIO groups.|||units on a scale||Standard Deviation|Mean
2535841|NCT03191552|Secondary|Gross Motor Function Measure-B, Sitting Dimension|Evaluates degree of achievement of sitting as a gross motor function. Gross Motor Function Measure sitting dimension is composed of 20 items. Each tem is scored according to special instructions on GMFM Manuel with a 4-point Likert scale including 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. If it is not possible to test an item, it should be noted as not tested (NT) It assesses degree of achievement of gross motor functions rather than quality of them. Minimum score is 0 while maxium score is 60(3x20).|3 months||||units on a scale||Standard Deviation|Mean
2535842|NCT03191552|Secondary|Gross Motor Function Measure-B, Sitting Dimension|Evaluates degree of achievement of sitting as a gross motor function. Gross Motor Function Measure sitting dimension is composed of 20 items. Each tem is scored according to special instructions on GMFM Manuel with a 4-point Likert scale including 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. If it is not possible to test an item, it should be noted as not tested (NT) It assesses degree of achievement of gross motor functions rather than quality of them. Minimum score is 0 while maxium score is 60(3x20).|1 month||||units on a scale||Standard Deviation|Mean
2535843|NCT03191552|Secondary|Gross Motor Function Measure-B, Sitting Dimension|Evaluates degree of achievement of sitting as a gross motor function. Gross Motor Function Measure sitting dimension is composed of 20 items. Each tem is scored according to special instructions on GMFM Manuel with a 4-point Likert scale including 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. If it is not possible to test an item, it should be noted as not tested (NT) It assesses degree of achievement of gross motor functions rather than quality of them. Minimum score is 0 while maxium score is 60(3x20).|2 weeks||||units on a scale||Standard Deviation|Mean
2535844|NCT03191552|Primary|Sitting Assessment Scale|Sitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively|3 months||||units on a scale||Standard Deviation|Mean
2535845|NCT03191552|Primary|Sitting Assessment Scale|Sitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively|1 month||||units on a scale||Standard Deviation|Mean
2535846|NCT03191552|Primary|Sitting Assessment Scale|Sitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively|2 weeks||||units on a scale||Standard Deviation|Mean
2535847|NCT03191552|Primary|Sitting Assessment Scale|Sitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively.|Immediate after orthosis is worn|The immediate effect of orthosis could only be evaluated in SPIO groups because the orthosis is tailor made and only children in SPIO groups had the orthosis. Given that the number of the objects in each SPIO group is 8, immediate effect of the orthosis could only be evaluated in children recruited in SPIO groups.|||units on a scale||Standard Deviation|Mean
2535848|NCT03191396|Secondary|Change in Pulse Rate|Mean change from baseline (week 0) to week 30 in pulse rate. Pulse rate is measured as number of heart beats per minute. Results are based on the on-treatment observation period where subjects were considered exposed to trial product. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|Week 0, week 30|Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product.|||beats/min||Geometric Coefficient of Variation|Geometric Mean
2535849|NCT03191396|Secondary|Change in Calcitonin|Mean change from baseline (week 0) to week 30 in calcitonin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.|Week 0, week 30|Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||ng/L||Geometric Coefficient of Variation|Geometric Mean
2535850|NCT03191396|Secondary|Change in Biochemistry - Estimated Glomerular Filtration Rate (eGFR).|Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameter eGFR. eGFR is calculated using the equation from the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) as defined in KDIGO guidelines. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.|Week 0, week 30|Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||mL/min/1.73m2||Geometric Coefficient of Variation|Geometric Mean
2535851|NCT03191396|Secondary|Change in Biochemistry - Albumin|Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameter albumin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.|Week 0, week 30|Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||g/dL||Geometric Coefficient of Variation|Geometric Mean
2535852|NCT03191396|Secondary|Change in Biochemistry - Creatinine and Bilirubin|Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters creatinine and bilirubin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.|Week 0, week 30|Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||umol/L||Geometric Coefficient of Variation|Geometric Mean
2535853|NCT03191396|Secondary|Change in Biochemistry - Amylase and Lipase|Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters amylase and lypase. Observed data with multiple imputation for missing data is presented. Missing data were imputed using observed data from subjects within the same group defined by actual treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.|Week 0, week 30|Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||U/L||Geometric Coefficient of Variation|Geometric Mean
2535854|NCT03191396|Secondary|Change in Biochemistry - Alkaline Phosphatase, Alanine Aminotransferase and Aspartate Aminotransferase.|Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters alkaline phosphatase, alanine aminotransferase and aspartate aminotransferase. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.|Week 0, week 30|Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||mmol/L||Geometric Coefficient of Variation|Geometric Mean
2535855|NCT03191396|Secondary|Change in Biochemistry - Calcium, Pottassium and Sodium|Mean change from baseline (week 0) to week 30 in biochemistry laboratory parameters calcium, pottassium and sodium. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.|Week 0, week 30|Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||mmol/L||Geometric Coefficient of Variation|Geometric Mean
2535856|NCT03191396|Secondary|Change in Haematology - Erythrocytes|Mean change from baseline (week 0) to week 30 in haematology laboratory parameter erythrocytes. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.|Week 0, week 30|Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||10^12 cells/L||Geometric Coefficient of Variation|Geometric Mean
2535857|NCT03191396|Secondary|Change in Haematology - Thrombocytes and Leukocytes|Mean change from baseline (week 0) to week 30 in haematology laboratory parameters thrombocytes and leukocytes. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.|Week 0, week 30|Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||10^9 cells/L||Geometric Coefficient of Variation|Geometric Mean
2536144|NCT03180489|Primary|Change From Baseline in Maker of Oxidative Stress (Oxidized Low Density Lipoprotein) at Week 12|Will be analyzed using a commercially available biochemical assay.|Data not collected|Data not collected||||||
2535858|NCT03191396|Secondary|Change in Haematology - Haematocrit|Mean change from baseline (week 0) to week 30 in haematology laboratory parameter haematocrit. Haematocrit is the volume of red blood cells in the total blood. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.|Week 0, week 30|Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||percent change||Geometric Coefficient of Variation|Geometric Mean
2535859|NCT03191396|Secondary|Change in Haematology - Haemoglobin|Mean change from baseline (week 0) to week 30 in haemoglobin. Results are based on the on-treatment observation period where subjects were considered exposed to trial product.|Week 0, week 30|Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||mmol/L||Geometric Coefficient of Variation|Geometric Mean
2535860|NCT03191396|Secondary|Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes|Number of subjects with treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemia episodes is presented. Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, where the subjects were exposed to the trial product. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or blood glucose confirmed by a plasma glucose value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Week 0 to week 35|Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||Participants|||Number
2535861|NCT03191396|Secondary|Number of Treatment-emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes|Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, where the subjects were exposed to the trial product. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or blood glucose confirmed by a plasma glucose value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Week 0 to week 35|Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||Episodes of hypoglycaemia|||Number
2535862|NCT03191396|Secondary|Number of Treatment-emergent Adverse Events (TEAE)|A TEAE was defined as an adverse event with onset date (or increase in severity) during the on-treatment observation period. The on-treatment observation period represents the time period where subjects were considered exposed to trial product.|Week 0 to week 35|Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||Events|||Number
2535863|NCT03191396|Secondary|Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ). Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately|"The DTSQs questionnaire was used to assess subject's treatment satisfaction. This instrument contains 8 items and measures the treatment for diabetes in terms of convenience, flexibility and general feelings regarding treatment. Q 1 = satisfaction with current treatment; Q 2 = hyperglycemia; Q 3 = hypoglycemia; Q 4 = flexibility; Q 5 = convenience; Q 6 = understanding of diabetes; Q 7 = recommend treatment to others; and Q 8 = willingness to continue. Each item is rated on a 7-point Likert scale with a score ranging from 0 (ie, very dissatisfied) to 6 (ie, very satisfied). DTSQ items 2 and 3 are rated differently: 0 reflects 'never' and 6 reflects 'most of the time'. The 'treatment satisfaction' score is the sum of 6 of the 8 DTSQs components (Q 1, 4, 5, 6, 7 and 8) (range 0-36). Higher scores on the DTSQ total score indicate higher treatment satisfaction. The results presented is the change from baseline (week 0) to week 30 in DTSQ scores."|Week 0, week 30|Full analysis set (FAS), which included all randomised participants. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|||scores on a scale||Standard Deviation|Mean
2535864|NCT03191396|Secondary|Change in SF-36v2 Short Form Health Survey. Total Summary Scores (Physical Component and Mental Component) and Scores From the 8 Domains|Short form-36 version 2 (SF-36v2) is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL). The questionnaire measures the individual overall HRQoL on 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Each domain is scored using the sum of the individual item responses and normalised relative to the 2009 US reference population. Overall, the domain scores range from around 0-100 (higher scores indicated a better HRQoL), where the range of possible scores depends on the 2009 US reference population for each domain. The two total summary scores (mental and physical summary components) are calculated through weighted sums of the 8 domain scores. The presented result is the change from baseline (week 0) to week 30 in SF-36v2 scores. A positive change in score indicates an improvement since baseline.|Week 0, week 30|Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.|||scores on a scale||Standard Deviation|Mean
2535865|NCT03191396|Secondary|Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 10%|Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 10% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|After 30 weeks of treatment|Full analysis set (FAS), which included all randomised participants.|||Percentage of participants|||Number
2535866|NCT03191396|Secondary|Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 5%|Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 5% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|After 30 weeks of treatment|Full analysis set (FAS), which included all randomised participants.|||Percentage of participants|||Number
2535867|NCT03191396|Secondary|Subjects Who Achieve HbA1c Reduction Above or Equal to 1% and Weight Loss Above or Equal to 3%|Percentage of subjects who achieved HbA1c reduction above or equal to 1% and weight loss above or equal to 3% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|After 30 weeks of treatment|Full analysis set (FAS), which included all randomised participants.|||Percentage of participants|||Number
2535868|NCT03191396|Secondary|Subjects Who Achieve HbA1c Reduction Above or Equal to 1%|Percentage of subjects who achieved weight loss above or equal to 1% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|After 30 weeks of treatment|Full analysis set (FAS), which included all randomised participants.|||Percentage of participants|||Number
2535869|NCT03191396|Secondary|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain|Percentage of subjects who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain, after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|After 30 weeks of treatment|Full analysis set (FAS), which included all randomised participants.|||Percentage of participants|||Number
2535870|NCT03191396|Secondary|Subjects Who Achieve Weight Loss Above or Equal to 10%|Percentage of subjects who achieved weight loss above or equal to 10% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|After 30 weeks of treatment|Full analysis set (FAS), which included all randomised participants.|||Percentage of participants|||Number
2535871|NCT03191396|Secondary|Subjects Who Achieve Weight Loss Above or Equal to 5%|Percentage of subjects who achieved weight loss above or equal to 5% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|After 30 weeks of treatment|Full analysis set (FAS), which included all randomised participants.|||Percentage of participants|||Number
2535872|NCT03191396|Secondary|Subjects Who Achieve Weight Loss Above or Equal to 3%|Percentage of subjects who achieved weight loss above or equal to 3% after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|After 30 weeks of treatment|Full analysis set (FAS), which included all randomised participants.|||percentage of participants|||Number
2535873|NCT03191396|Secondary|Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target|Percentage of subjects who achieved HbA1c less than 6.5% (48 mmol/mol) according to AACE target,after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|After 30 weeks of treatment|Full analysis set (FAS), which included all randomised participants.|||percentage of participants|||Number
2535874|NCT03191396|Secondary|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target|Percentage of subjects who achieved HbA1c less than 7.0% (53 mmol/mol) according to American Diabetes Association (ADA) target, after 30 weeks of treatment. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|After 30 weeks of treatment|Full analysis set (FAS), which included all randomised participants.|||percentage of participants|||Number
2535875|NCT03191396|Secondary|Change in Body Weight (%)|Mean relative change from baseline in body weight measured in percentage. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|Week 0, week 30|Full analysis set (FAS), which included all randomised participants.|||percentage of body weight||Standard Deviation|Mean
2535876|NCT03191396|Secondary|Change in Diastolic Blood Pressure|Change in diastolic blood pressure from baseline (week 0) to week 30 . Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|Week 0, week 30|Full analysis set (FAS), which included all randomised participants.|||mmHg||Standard Deviation|Mean
2535877|NCT03191396|Secondary|Change in Systolic Blood Pressure|Change in systolic blood pressure from baseline (week 0) to week 30 . Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|Week 0, week 30|Full analysis set (FAS), which included all randomised participants.|||mmHg||Standard Deviation|Mean
2536145|NCT03180489|Primary|Change From Baseline in Hunger Hormone Peptide Tyrosine Tyrosine at Week 12|Will be analyzed using a commercially available biochemical assay.|data not collected|Data not collected||||||
2535878|NCT03191396|Secondary|Change in Waist Circumference|Mean change in waist circumference (cm) from baseline (week 0) to week 30. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|Week 0, week 30|Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.|||cm||Standard Deviation|Mean
2535879|NCT03191396|Secondary|Change in Body Mass Index (BMI)|Mean change from baseline (week 0) to week 30 in BMI. BMI was calculated as 'body weight in kg/(height in meters) x (height in meters)'. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|Week 0, week 30|Full analysis set (FAS), which included all randomised participants.|||kg/sqm||Standard Deviation|Mean
2535880|NCT03191396|Secondary|Change in Fasting Blood Lipids: Triglycerides|The change from baseline in triglycerides is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|Week 0, week 30|Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2535881|NCT03191396|Secondary|Change in Fasting Blood Lipids: High-density Lipoprotein (HDL)-Cholesterol|The change from baseline in HDL cholesterol is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|Week 0, week 30|Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2535882|NCT03191396|Secondary|Change in Fasting Blood Lipids: Low-density Lipoprotein (LDL)-Cholesterol|The change from baseline in LDL cholesterol is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|Week 0, week 30|Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2535883|NCT03191396|Secondary|Change in Fasting Blood Lipids: Total Cholesterol|The change from baseline in total cholesterol (measured in mmol/L) is presented as ratio to baseline. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|Week 0, week 30|Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2535884|NCT03191396|Secondary|Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals)|Mean post prandial glucose incrememts over all meals. Results are based on the on-treatment without rescue medication period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|Week 0, week 30|Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2535885|NCT03191396|Secondary|Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile|Mean change from baseline in 7-point profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. The mean of the 7-point SMPG profile, defined as the area under the profile, was calculated using the trapezoidal method and divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|Week 0, week 30|Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2535886|NCT03191396|Secondary|Change in Fasting Plasma Glucose (FPG)|Mean change from baseline in fasting plasma glucose measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|Week 0, week 30|Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2535887|NCT03191396|Secondary|Change in Body Weight (kg)|Mean change from baseline (week 0) to week 30 in body weight measured in kilograms. Results are based on the 'on-treatment without rescue medication' observation period. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|Week 0, week 30|Full analysis set (FAS), which included all randomised participants.|||kg||Standard Deviation|Mean
2536146|NCT03180489|Primary|Change From Baseline in Hunger Hormone Ghrelin at Week 12|Will be analyzed using a commercially available biochemical assay.|data not collected|Data not collected||||||
2536147|NCT03180489|Primary|Change From Baseline in Marker of Inflammation (Interleukin 6) at Week 12|Will be analyzed using a commercially available biochemical assay.|data not collected|Data not collected||||||
2535888|NCT03191396|Primary|Change in HbA1c|Mean change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) %. The endpoint was evaluated based on the 'on-treatment without rescue medication period' where subjects were considered treated with trial product, but had not yet initiated rescue medication. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.|Week 0, week 30|Full analysis set (FAS), which included all randomised participants.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
2535889|NCT03190369|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed, worsened (according to the Investigator opinion), or became serious during the on-treatment period (time from the injection of IMP up to Week 26 follow-up visit).|From Baseline up to Week 26|Analysis was performed on safety population which included randomized participants who received at least 1 injection or part of an injection of Hylan G-F 20 or placebo.|||Participants|||Count of Participants
2535890|NCT03190369|Secondary|Percentage of Positive WOMAC A1 Responder Over 26 Weeks|WOMAC A1 responder were defined as >=2-point improvement from baseline in the WOMAC A1 NRS. The WOMAC NRS version 3.1 questionnaire was a self-administered, health status measure questionnaire of 24 questions comprising 3 subscales (joint pain, stiffness and physical function) for participants with OA of the knee. WOMAC A1 pain subscale (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represented no pain and higher score represented extreme pain.|Week 4, Week 8, Week 12, Week 16, Week 20 and Week 26|Analysis was performed on mITT population.|||percentage of participants|||Number
2535891|NCT03190369|Secondary|Change From Baseline in Clinical Observer Global Assessment (COGA) Score of Osteoarthritis Over 26 Weeks|COGA was used by the physicians to perform a global assessment of the participant's target knee OA condition. The response was captured using the 11-point NRS pain intensity rating scale ranging from 0 (best possible) to 10 (worst possible) at the specified time points, where lower score represented best possible condition and higher score represented worst possible condition.|From Baseline up to Week 26|Analysis was performed on mITT population.|||score on a scale||Standard Error|Least Squares Mean
2535892|NCT03190369|Secondary|Change From Baseline in Patient Global Self-Assessment (PTGA) Score of Osteoarthritis Over 26 Weeks|PTGA (self-assessment of target knee OA condition) was measured using an 11-point NRS ranging from 0 (best possible) to 10 (worst possible), where lower score represented best possible condition and higher score represented worst possible condition.|From Baseline up to Week 26|Analysis was performed on mITT population.|||score on a scale||Standard Error|Least Squares Mean
2535893|NCT03190369|Secondary|Change From Baseline in WOMAC A Score Over 26 Weeks|The WOMAC NRS version 3.1 questionnaire was a self-administered, health status measure questionnaire of 24 questions comprising 3 subscales (joint pain, stiffness and physical function) for participants with OA of the knee. WOMAC A (5 items: measure of pain while walking, using stairs, at night while in bed, sitting or lying, and standing); each item was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represented no pain and higher score represented extreme pain. Total WOMAC A score was the sum of 5 item scores and ranges from 0 (none) to 50 (extreme); where lower score represented no pain and higher score represented extreme pain.|From Baseline up to Week 26|Analysis was performed on mITT population.|||score on a scale||Standard Error|Least Squares Mean
2535894|NCT03190369|Secondary|Change From Baseline in 7-day Average WOMAC A1 Pain (Walking Pain) Subscale Score Over 26 Weeks|The WOMAC NRS version 3.1 questionnaire was a self-administered, health status measure questionnaire of 24 questions comprising 3 subscales (joint pain, stiffness and physical function) for participants with OA of the knee. WOMAC A1 pain subscale (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represented no pain and higher score represented extreme pain. For 7-day average WOMAC A1, the baseline value was defined as the average of the WOMAC A1 scores recorded 7 days prior to the first investigational medicinal product (IMP) administration (WOMAC A1 score recorded on Day 1 included). The 7-day average WOMAC A1 was set as missing if 3 or more of the 7 WOMAC A1 scores were missing.|From Baseline up to Week 26|Analysis was performed on mITT population.|||score on a scale||Standard Error|Least Squares Mean
2535895|NCT03190369|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Pain (Walking Pain) Subscale Score Over 26 Weeks|The WOMAC Numerical Rating Scale (NRS) version 3.1 questionnaire was a self-administered, health status measure questionnaire of 24 questions comprising 3 subscales (joint pain, stiffness and physical function) for participants with Osteoarthritis (OA) of the knee. WOMAC A1 pain subscale (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represented no pain and higher score represented extreme pain.|From Baseline up to Week 26|Analysis was performed on modified Intent-To-Treat (mITT) population which included all randomized and treated participants. Participants were analyzed in the treatment group to which they were randomized.|||score on a scale||Standard Error|Least Squares Mean
2535896|NCT03190213|Secondary|Number of Patients With Adverse Events Reported|Adverse Events were reported using the Common Terminology Criteria for Adverse Events (CTCAE) version 4. Each adverse event reported is assigned a severity grade from 1 to 5, where 1 is mild, 2 is moderate, 3 is severe, 4 is life threatening, and 5 indicates the event resulted in death. The number of patients experiencing any Grade 1-2 event and the number of patients experiencing any Grade 3 event are reported. There were no Grade 4 or Grade 5 events reported on this study. AEs were reported during study treatment and up to 90 days after last dose of treatment.|planned for up to two years of treatment plus 90 days; actual time was up to 338 days (average of 170 days)||||Participants|||Count of Participants
2535910|NCT03189589|Secondary|Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance|Twelve-lead ECG was obtained using an ECG machine which automatically measured PR, QRS, QT and corrected QT (QTc) intervals. ECG parameters and their potential clinical importance range values were: absolute QTc interval (lower >450 milliseconds [msec]), absolute PR interval (lower <110 msec and upper >220 msec), absolute QRS interval (lower <75 msec and upper >110 msec). Number of participants with electrocardiogram (ECG) values of potential clinical importance are presented.|Up to Day 2|Safety Population.|||Participants|||Number
2535897|NCT03190213|Secondary|Median Overall Survival|Overall survival (OS) is the length of time from the start of treatment that a participant lives. OS was measured as the time from first dose of pembrolizumab until the death of the participant or the end of follow-up (whichever was first), and is reported as the median number of days patients survived as calculated by the Kaplan-Meier method. This study was intended to follow participants up to four years after the initiation of study treatment, but the study and the follow-up period were terminated prematurely. The maximum follow up was 360 days.|planned for up to four years from baseline; actual time was up to 230 days (average of 70.5 days)||||days||95% Confidence Interval|Median
2535898|NCT03190213|Secondary|Median Progression Free Survival|Progression free survival (PFS) is the length of time during and after treatment that a participant lives and the disease does not get worse. PFS was measured as the time from first dose of pembrolizumab until disease progression by irRECIST criteria (>= 20% increase in target lesion measurements), and is reported as the median number of days patients survived without disease progression as calculated by the Kaplan-Meier method.|planned for up to four years from baseline; actual time was up to 230 days (average of 70.5 days)||||days||95% Confidence Interval|Median
2535899|NCT03190213|Secondary|Clinical Benefit Rate|"Clinical benefit was measured using irRECIST. At baseline, lesions found on CT or MRI imaging are cataloged as target or non-target lesions, and the longest dimensions of target lesions (or shortest dimension of target lymph nodes) are summed. irRECIST defines irCR as a complete disappearance of all lesions after baseline. irPR is defined as a 30% or more decrease in the target lesion measurements. Progressive Disease (irPD) is a defined as a 20% or more increase in target lesion measurements. Stable Disease (irSD) is neither a sufficient shrinkage to qualify as irPR or irCR nor an increase that would qualify as irPD. Clinical Benefit Rate is defined as the percentage of participants with a best response of irCR + irPR + irSD."|planned for up to two years from baseline; actual time was up to 230 days (average of 70.5 days)||||percentage of participants||95% Confidence Interval|Number
2535900|NCT03190213|Primary|Overall Response Rate|"Overall response was measured using Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST). At baseline, lesions found on CT or MRI imaging are cataloged as target or non-target lesions, and the longest dimensions of target lesions (or shortest dimension of target lymph nodes) are summed. irRECIST defines Complete Response (irCR) as a complete disappearance of all lesions after baseline. Partial Response (irPR) is defined as a 30% or more decrease in the target lesion measurements. Overall response rate is defined the percentage of participants with a best response of irCR + irPR."|planned for up to two years from baseline; actual time was up to 230 days (average of 70.5 days)||||percentage of participants||95% Confidence Interval|Number
2535901|NCT03190083|Other Pre-specified|Number of Patients Undergoing Additional Work-up Following the DBT With Benign Findings||At completion of 3-Dimensional mammogram (1 day)|||||||
2535902|NCT03190083|Other Pre-specified|The Proportion of Patients Undergoing Additional Work-up Following the DBT||At completion of 3-Dimensional mammogram (1 day)|||||||
2535903|NCT03190083|Other Pre-specified|Variables on 2-Dimensional Mammogram That Might Predict Which Patients Would Benefit From DBT||At completion of 3-Dimensional mammogram (1 day)|||||||
2535904|NCT03190083|Primary|Number of Participants for Which DBT Altered Surgical Plan|Only positive findings, like an additional site of cancer or atypical pathology like Atypical ductal/ lobular hyperplasia, papilloma, DCIS/LCIS (findings requiring surgical intervention), will be taken into account when estimating the frequency of changes to surgical management|At completion of 3-Dimensional mammogram (1 day)||||Participants|||Count of Participants
2535905|NCT03190005|Primary|PRU(Platelet Rreactivity Unit) 24 Hours After DAPT(Dual AntiPlatelet Therapy) Western Blot After Medication|PRU(Platelet Rreactivity Unit) 24 hours after DAPT(Dual AntiPlatelet Therapy) Western blot after medication|24 hours|PRU(Platelet Rreactivity Unit) 24 hours after DAPT(Dual AntiPlatelet Therapy) Western blot after medication|||PRU(Platelet Rreactivity Unit)|blood sample|Standard Deviation|Mean
2535906|NCT03189589|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to 12 days post-dose|Safety Population.|||Participants|||Number
2535907|NCT03189589|Secondary|Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance|Clinical chemistry parameters and their potential clinical concern range values were: calcium (low flag <2 millimoles/Liter [mmol/L] and high flag >2.75 mmol/L), creatinine (high flag >44.2 micromoles/Liter increase in change from Baseline), glucose (fasting) (<3 mmol/L and >9 mmol/L), potassium (low flag <3 mmol/L and high flag >5.5 mmol/L above ULN), sodium (low flag <130 mmol/L and high flag >150 mmol/L). Number of participants with clinical chemistry abnormalities of potential clinical importance are presented.|Up to Day 2|Safety Population.|||Participants|||Number
2535908|NCT03189589|Secondary|Number of Participants With Hematology Abnormalities of Potential Clinical Importance|Hematology parameters and their potential clinical concern values were: Hematocrit (high flag: >0.54 and change from Baseline: decrease of 0.075), hemoglobin (high flag: >180 grams per Liter and change from Baseline: decrease of 25 grams per Liter), lymphocytes (low flag: <0.8*10^9 cells per Liter), neutrophil count (low flag: <1.5*10^9 cells per Liter), platelet count (low flag: <100*10^9 cells per Liter and high flag: >550*10^9 cells per Liter) and white blood cell count (low flag: <3*10^9 cells per Liter and high flag: >20*10^9 cells per Liter). Number of participants with hematology abnormalities of potential clinical importance are presented.|Up to Day 2|Safety Population.|||Participants|||Number
2535909|NCT03189589|Secondary|Change From Baseline in Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 Second (FEV1)|The maximal amount of air forcefully exhaled in 1 second (FEV1) and forced vital capacity (FVC) was measured using a spirometer. Baseline was latest pre-dose assessment. Change from Baseline was calculated by subtracting Baseline values from post-dose visit values. Mean change from Baseline in FVC and FEV1 is presented.|Baseline and Day 1|Safety Population.|||Liters (L)||Standard Deviation|Mean
2535911|NCT03189589|Secondary|Number of Participants With Vital Signs of Potential Clinical Importance|Vital signs included blood pressure (systolic and diastolic blood pressure) and heart rate measurements and were assessed with the participant in a semi-supine position after 5 minutes rest. The potential clinical concern range values for vital signs were: systolic blood pressure (lower <85 millimeters of mercury and higher >160 millimeters of mercury), diastolic blood pressure (lower <45 millimeters of mercury and higher >100 millimeters of mercury) and heart rate (lower <40 beats per minute and higher >110 beats per minute). Number of participants with vital signs of potential clinical importance are presented. Safety Population comprised of all randomized participants who received at least one dose of study treatment.|Up to Day 2|Safety Population|||Participants|||Number
2535912|NCT03189589|Primary|Time to Maximum Observed Plasma Drug Concentration (Tmax) and Terminal Half-life (t1/2)|Blood samples were collected to evaluate the PK of GSK2269557 at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. Only those participants with data available at the specified time points were analyzed represented by n=X in the category titles.|Day 1: Pre-dose, 5 minutes post dose, 30 minutes post-dose, 2 hours post-dose, 6 hours post-dose, 12 hours post-dose; Day 2: 24 hours post-dose; Day 3: 48 hours post-dose and Day 6: 120 hours post-dose|PK Population.|||Hours||Full Range|Median
2535913|NCT03189589|Primary|Maximum Observed Plasma Drug Concentration (Cmax) and Concentration at Trough (Ctrough) of GSK2269557|Blood samples were collected to evaluate the PK of GSK2269557 at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.|Day 1: Pre-dose, 5 minutes post dose, 30 minutes post-dose, 2 hours post-dose, 6 hours post-dose, 12 hours post-dose; Day 2: 24 hours post-dose; Day 3: 48 hours post-dose and Day 6: 120 hours post-dose|PK Population.|||Picograms per milliliter||Standard Deviation|Mean
2535914|NCT03189589|Primary|Area Under the Plasma Drug Concentration Versus Time Curve (AUC) From Zero to Time t (AUC [0 to t]), AUC From Zero to 24 Hours (AUC [0 to 24]) and AUC From Zero to Infinity (AUC [0 to Inf]) of GSK2269557|Blood samples were collected to evaluate the PK of GSK2269557 at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. Only those participants with data available at the specified time points were analyzed represented by n=X in the category titles.|Day 1: Pre-dose, 5 minutes post dose, 30 minutes post-dose, 2 hours post-dose, 6 hours post-dose, 12 hours post-dose; Day 2: 24 hours post-dose; Day 3: 48 hours post-dose and Day 6: 120 hours post-dose|PK Population.|||Hours*picograms per milliliter||Standard Deviation|Mean
2535915|NCT03189589|Primary|Mean GSK2269557 Plasma Concentration|Whole blood samples of approximately 2 milliliters were collected for measurement of plasma concentrations of GSK2269557 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic (PK) Population which comprised of all randomized participants in the Safety Population and for whom a PK sample was obtained and analyzed.|Day 1: Pre-dose, 5 minutes post dose, 30 minutes post-dose, 2 hours post-dose, 6 hours post-dose, 12 hours post-dose; Day 2: 24 hours post-dose; Day 3: 48 hours post-dose and Day 6: 120 hours post-dose|PK Population.|||Picograms per milliliter||Standard Deviation|Mean
2535916|NCT03188523|Secondary|Apparent Terminal Half Life of Tenofovir in Plasma (t½)|Plasma samples were collected in a fasted state pre- and post-dose and used to determine t½ of plasma tenofovir. t½ was defined as the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-8504.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available plasma PK data.|||hr||Geometric Coefficient of Variation|Geometric Mean
2535917|NCT03188523|Secondary|Maximum Concentration of Tenofovir in Plasma (Cmax)|Plasma samples were collected in a fasted state pre- and post-dose and used to determine Cmax of plasma tenofovir. Cmax was defined as the maximum concentration of tenofovir in plasma observed, following a single dose of MK-8504.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available plasma PK data.|||μM||Geometric Coefficient of Variation|Geometric Mean
2535918|NCT03188523|Secondary|Time to Maximum Concentration of Tenofovir in Plasma (Tmax)|Plasma samples were collected in a fasted state pre- and post-dose and used to determine Tmax of plasma tenofovir. Tmax was defined as the time at which maximum concentration of tenofovir in plasma was observed, following a single dose of MK-8504.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available plasma PK data.|||Hour (hr)||Full Range|Geometric Mean
2535919|NCT03188523|Secondary|Area Under the Concentration-Time Curve of Tenofovir in Plasma From Time 0 to 168 Hours (AUC0-168hr)|Plasma samples were collected in a fasted state pre- and post-dose and used to determine AUC0-168hr of plasma tenofovir. Because plasma tenofovir was expected to rapidly disappear from plasma based on prior experience with healthy participants, sampling was done until 72 hrs and AUC0-168 hr was computed from these data assuming 1) a mono-exponential concentration decline after 72hrs; 2) accurate estimation of the elimination rate based on available data; and 3) no involvement of other processes besides elimination after 72 hrs.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available plasma PK data.|||μM·hr||Geometric Coefficient of Variation|Geometric Mean
2535920|NCT03188523|Secondary|Area Under the Concentration-Time Curve of Tenofovir in Plasma From Time 0 to Infinity (AUC0-inf)|Plasma samples were collected in a fasted state pre- and post-dose and used to determine AUC0-inf of plasma tenofovir. AUC0-inf was defined as the area under the concentration time curve of plasma tenofovir from time 0 to infinite time, following a single dose of MK-8504.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available plasma PK data.|||μM·hr||Geometric Coefficient of Variation|Geometric Mean
2536148|NCT03180489|Primary|Change From Baseline in Marker of Inflammation (Tumor Necrosis Factor Alpha) at Week 12|Will be analyzed using a commercially available biochemical assay.|Data not collected|Data not collected||||||
2535921|NCT03188523|Secondary|Area Under the Concentration-Time Curve of Tenofovir in Plasma From Time 0 to Last Measurable Concentration (AUC0-last)|Plasma samples were collected in a fasted state pre- and post-dose and used to determine AUC0-last of plasma tenofovir. AUC0-last was defined as the area under the concentration time curve of plasma tenofovir from time 0 to last measurement, following a single dose of MK-8504.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available plasma pharmacokinetic (PK) data.|||μM·hr||Geometric Coefficient of Variation|Geometric Mean
2535922|NCT03188523|Secondary|Intracellular Concentration of Tenofovir-Diphosphate (TFV-DP) at 168 Hours (Intracellular C168hr) In Peripheral Blood Mononuclear Cells (PBMCs)|Blood samples were collected in a fasted state, processed for PBMC samples, and used to determine the intracellular C168hr of TFV-DP. TFV-DP is formed via metabolism of MK-8504 in plasma, PBMC and in other tissues. Intracellular C168hr was defined as the intracellular concentration of TFV-DP in PBMCs at 168 hours, following a single dose of MK-8504.|168 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available PBMC PK data.|||μM||Geometric Coefficient of Variation|Geometric Mean
2535923|NCT03188523|Secondary|Intracellular Apparent Terminal Half Life (Intracellular t½) of Tenofovir-Diphosphate (TFV-DP) In Peripheral Blood Mononuclear Cells (PBMCs)|Blood samples were collected in a fasted state pre- and post-dose, processed for PBMC samples, and used to determine the intracellular t½ of TFV-DP. TFV-DP is formed via metabolism of MK-8504 in plasma, PBMC and in other tissues. Intracellular t½ was defined as the time required to divide the intracellular concentration by two after reaching pseudo-equilibrium, following a single dose of MK-8504.|Pre-dose, 4, 12, 24, 48, 72, 96, 168, 240, 384, and 600 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available PBMC PK data.|||hour (hr)||Geometric Coefficient of Variation|Geometric Mean
2535924|NCT03188523|Secondary|Intracellular Maximum Concentration (Intracellular Cmax) of Tenofovir-Diphosphate (TFV-DP) In Peripheral Blood Mononuclear Cells (PBMCs)|Blood samples were collected in a fasted state pre- and post-dose, processed for PBMC samples, and used to determine the intracellular Cmax of TFV-DP. TFV-DP is formed via metabolism of MK-8504 in plasma, PBMC and in other tissues. Intracellular Cmax was defined as the maximum intracellular concentration of TFV-DP in PBMCs observed, following a single dose of MK-8504.|Pre-dose, 4, 12, 24, 48, 72, 96, 168, 240, 384, and 600 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available PBMC PK data.|||μM||Geometric Coefficient of Variation|Geometric Mean
2535925|NCT03188523|Secondary|Intracellular Time to Maximum Concentration (Intracellular Tmax) of Tenofovir-Diphosphate (TFV-DP) In Peripheral Blood Mononuclear Cells (PBMCs)|Blood samples were collected in a fasted state pre- and post-dose, processed for PBMC samples, and used to determine the intracellular Tmax of TFV-DP. TFV-DP is formed via metabolism of MK-8504 in plasma, PBMC and in other tissues. Intracellular Tmax was defined as the time at which maximum intracellular concentration of TFV-DP in PBMCs was observed, following a single dose of MK-8504.|Pre-dose, 4, 12, 24, 48, 72, 96, 168, 240, 384, and 600 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available PBMC PK data.|||hours (hr)||Full Range|Geometric Mean
2535926|NCT03188523|Secondary|Intracellular Area Under the Concentration-Time Curve of Tenofovir-Diphosphate (TFV-DP) From Time 0 to Infinity (Intracellular AUC0-inf) In Peripheral Blood Mononuclear Cells (PBMCs)|Blood samples were collected in a fasted state pre- and post-dose, processed for PBMC samples, and used to determine the intracellular AUC0-inf of TFV-DP in PBMCs. TFV-DP is formed via metabolism of MK-8504 in plasma, PBMC and in other tissues. Intracellular AUC0-inf was defined as the area under the concentration time curve of TFV-DP in PBMCs from time 0 to infinite time, following a single dose of MK-8504.|Pre-dose, 4, 12, 24, 48, 72, 96, 168, 240, 384, and 600 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available PBMC PK data.|||μM·hr||Geometric Coefficient of Variation|Geometric Mean
2535927|NCT03188523|Secondary|Intracellular Area Under the Concentration-Time Curve of Tenofovir-Diphosphate (TFV-DP) From Time 0 to 168 Hours (Intracellular AUC0-168hr) In Peripheral Blood Mononuclear Cells (PBMCs)|Blood samples were collected in a fasted state pre- and post-dose, processed for PBMC samples, and used to determine the intracellular AUC0-168hr of TFP-DP in PBMCs. TFV-DP is formed via metabolism of MK-8504 in plasma, PBMC and in other tissues. Intracellular AUC0-168hr was defined as the area under the concentration time curve of TFV-DP in PBMCs from time 0 to 168 hours, following a single dose of MK-8504.|Pre-dose, 4, 12, 24, 48, 72, 96, and 168 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available PBMC PK data.|||μM·hr||Geometric Coefficient of Variation|Geometric Mean
2535928|NCT03188523|Secondary|Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8504 in Plasma|Plasma samples were collected in a fasted state pre- and post-dose and used to determine Vz/F of plasma MK-8504. Vz/F was defined as the apparent volume of distribution of the drug in plasma during the terminal phase after non-intravenous administration, following a single dose of MK-8504.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available plasma PK data.|||liters (L)||Geometric Coefficient of Variation|Geometric Mean
2535929|NCT03188523|Secondary|Apparent Total Clearance of MK-8504 in Plasma (CL/F)|Plasma samples were collected in a fasted state pre- and post-dose and used to determine CL/F of plasma MK-8504. CL/F was defined as the apparent total clearance of the drug from plasma after oral administration, following a single dose of MK-8504.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available plasma PK data.|||liters (L)/hr||Geometric Coefficient of Variation|Geometric Mean
2536149|NCT03180489|Primary|Change From Baseline in Marker of Inflammation (High Sensitive C-reactive Protein) at Week 12|Will be analyzed using a commercially available biochemical assay.|Data not collected|Data not collected||||||
2535930|NCT03188523|Secondary|Apparent Terminal Half Life of MK-8504 in Plasma (t½)|Plasma samples were collected in a fasted state pre- and post-dose and used to determine t½ of plasma MK-8504. t½ was defined as the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, following a single dose of MK-8504.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available plasma PK data.|||hr||Geometric Coefficient of Variation|Geometric Mean
2535931|NCT03188523|Secondary|Maximum Concentration of MK-8504 in Plasma (Cmax)|Plasma samples were collected in a fasted state pre- and post-dose and used to determine Cmax of plasma MK-8504. Cmax was defined as the maximum concentration of MK-8504 in plasma observed, following a single dose of MK-8504.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available plasma PK data.|||μM||Geometric Coefficient of Variation|Geometric Mean
2535932|NCT03188523|Secondary|Time to Maximum Concentration of MK-8504 in Plasma (Tmax)|Plasma samples were collected in a fasted state pre- and post-dose and used to determine Tmax of plasma MK-8504. Tmax was defined as the time at which maximum concentration of MK-8504 in plasma was observed, following a single dose of MK-8504.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available plasma PK data.|||Hour (hr)||Full Range|Geometric Mean
2535933|NCT03188523|Secondary|Area Under the Concentration-Time Curve of MK-8504 in Plasma From Time 0 to 168 Hours (AUC0-168hr)|Plasma samples were collected in a fasted state pre- and post-dose and used to determine AUC0-168hr of plasma MK-8504. Because plasma MK-8504 was expected to rapidly disappear from plasma based on prior experience with healthy participants, sampling was done until 72 hrs and AUC0-168 hr was computed from these data assuming 1) a mono-exponential concentration decline after 72hrs; 2) accurate estimation of the elimination rate based on available data; and 3) no involvement of other processes besides elimination after 72 hrs.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available plasma PK data.|||μM·hr||Geometric Coefficient of Variation|Geometric Mean
2535934|NCT03188523|Secondary|Area Under the Concentration-Time Curve of MK-8504 in Plasma From Time 0 to Infinity (AUC0-inf)|Plasma samples were collected in a fasted state pre- and post-dose and used to determine AUC0-inf of plasma MK-8504. AUC0-inf was defined as the area under the concentration time curve of plasma MK-8504 from time 0 to infinite time, following a single dose of MK-8504.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available plasma PK data.|||μM·hr||Geometric Coefficient of Variation|Geometric Mean
2535935|NCT03188523|Secondary|Area Under the Concentration-Time Curve of MK-8504 in Plasma From Time 0 to Last Measurable Concentration (AUC0-last)|Plasma samples were collected in a fasted state pre- and post-dose and used to determine AUC0-last of plasma MK-8504. AUC0-last was defined as the area under the concentration time curve of plasma MK-8504 from time 0 to last measurement, following a single dose of MK-8504.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 12, 24, 36, 48, and 72 hours post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with the study procedure, and had available plasma pharmacokinetic (PK) data.|||μM·hr||Geometric Coefficient of Variation|Geometric Mean
2535936|NCT03188523|Primary|Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product, was also an AE. The number of participants that discontinued study treatment due to an AE was reported for each arm.|Day 1|All participants that received at least one dose of treatment.|||Participants|||Count of Participants
2535937|NCT03188523|Primary|Number of Participants Who Experienced At Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product, was also an AE. The number of participants experiencing at least one AE was reported for each arm.|From Day 1 through Post-Trial Visit (up to 25 days)|All participants that received at least one dose of treatment.|||Participants|||Count of Participants
2535938|NCT03188523|Primary|Change From Baseline in Plasma HIV-1 Ribonucleic Acid (RNA) at 168 Hours Post-Dose|Plasma samples were collected from participants after a single dose of MK-8504 to assess viral load. The log10 plasma HIV-RNA (copies/mL) measurements from participants in each panel were pooled and analyzed based on a longitudinal data analysis model. Change from baseline to 168 hours post-dose was determined for each treatment group. Results are expressed as change in HIV RNA log10 (copies/mL).|Baseline, 168 hours post-dose|All randomized participants|||log10 (copies/mL)||95% Confidence Interval|Least Squares Mean
2535983|NCT03184441|Secondary|Number of Participants With Normal Cranial Index|Cranial index (An objective front to back and side to side, measure that quantifies head shape by dividing head width by length then multiplying it by 100%) for each of participants was measured at study completion. Participants falling within the normal range of 73%-85% had normal cranial index.|Cranial index at study completion|Normal cranial index at study completion|||Participants|||Count of Participants
2535984|NCT03184441|Secondary|Feasibility of Use of the Premie Pouch in VLBW Infants|Documented hours per day (24 hours) on the Premie Pouch device|Number of hours per each 24 hour period on the device|Hours on device per day|||hours per day||Full Range|Mean
2535939|NCT03188120|Secondary|The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline|"The change from baseline in asthma control status at week 12 using Asthma prevention and management guideline is presented.~Well controlled is a better outcome compared to Insufficiently controlled and Poorly controlled outcomes.~Abbreviations used:~Baseline (BL), Week 12 (W12), Well-controlled (WC), Insufficiently controlled (IC), Poorly controlled (PC), Unknown (UNK), Missing (MIS); If a patient was well-controlled at baseline and maintained the state until Week 12, the effectiveness was assessed as no change. If a patient insufficiently controlled or poorly controlled at baseline became well-controlled at Week 12, or if a patient was poorly controlled at baseline and became insufficiently controlled at Week 12, Spiriva Respimat was assessed as effective (or the patient assessed as a responder). If the disease condition did not improve in a patient at Week 12 from baseline, Spiriva Respimat was assessed as ineffective (or the patient assessed as a non-responder)."|baseline and 12 weeks|Effectiveness set that excluded patients who were not associated with effectiveness data available (pulmonary function test or laboratory values related to asthma control status) as defined at baseline and/or on treatment.|||participants|||Number
2535940|NCT03188120|Primary|Number of Participants With Suspected Adverse Drug Reactions (ADRs)|"Number of participants with suspected adverse drug reactions (ADRs) is presented.~An Adverse Event (AE) was considered to be ADR if either the physician who reported the AE or the sponsor assessed its causal relationship as related."|From first drug administration until 30 days after last drug administration; up to 337 days|Safety set|||Participants|||Count of Participants
2535941|NCT03187756|Secondary|Time to Platelet Recovery|Platelet recovery is defined as sustained platelet count greater than or equal to 20,000/mm3 or greater than or equal to 50,000/mm3 with no platelet transfusions in the preceding seven days. The first of three consecutive measurements on different days will be designated as the day of initial platelet recovery.|1 year||||days||Full Range|Mean
2535942|NCT03187756|Secondary|Time to Neutrophil Recovery|Neutrophil recovery is defined as post-nadir ANC greater than or equal to 500/mm3 for three consecutive measurements on different days. The first of the three days will be designated as the day of neutrophil recovery.|1 year||||days||Full Range|Mean
2535943|NCT03187756|Secondary|Graft Failure Frequency|Graft failure and death, or graft failure, death and treatment of relapse/progressions. This will be reported as the number of participants with graft failures.|1 year||||Participants|||Count of Participants
2535944|NCT03187756|Secondary|Cumulative Incidences of Systemic Steroid Initiation|Estimate the cumulative incidence of systemic steroid initiation, by 1 year after HSCT. This is will be reported as number of participants who started steroids over the course of the study.|1 year||||Participants|||Count of Participants
2535945|NCT03187756|Secondary|Number of Major Toxicities and Complications Associated With Transplantation Procedure|Summarize major toxicities and complications associated with the transplantation procedure|1 year|While AE data was reported (see AE / SAE section), due to termination of the study, relationship of major AEs to transplant procedures was unable to be assessed. Therefore, this information cannot be reported.||||||
2535946|NCT03187756|Secondary|Number of Participants With Chronic GVHD and Grades I-IV GVHD|Acute GVHD is graded by standard criteria, and all suspected cases of acute GVHD will be confirmed histologically by biopsy of an affected organ. The severity of acute GVHD is determined by an assessment of the degree of involvement of the skin, liver, and gastrointestinal tract. Grade I is characterized as mild disease (skin involvement alone), Grade II as moderate, Grade III as severe (involvement of any organ system), and Grade IV as life-threatening. The diagnosis of a chronic GVHD per NIH criteria requires a) at least 1 diagnostic manifestation or b) 1 distinctive manifestation confirmed by biopsy or testing of the same or other involved organ.|1 year||||Participants|||Count of Participants
2535947|NCT03187756|Primary|Event Free Survival (EFS)|Estimate the one year after transplantation event free survival (EFS) rate using a Kaplan-Meier curve with a 90% confidence interval. An event for EFS is defined as the first of any of the following failures: relapse or disease progression or death from any cause|One Year|2 participants reached the 1 year time point but disease assessment was completed for only 1 subject (complete remission).|||Participants|||Count of Participants
2535948|NCT03187678|Primary|Number of Participants With PAH-related Adverse Events|This is the number of participants with at least one AE considered to be related to pulmonary arterial hypertension during the course of the study.|From Day 1 to Day 37|Safety analysis set including all enrolled subjects who received at least one dose of Uptravi or intravenous selexipag during any of the study periods|||Participants|||Count of Participants
2535949|NCT03187678|Primary|Number of Participants With Prostacyclin-associated AEs Leading to Study Treatment Discontinuation|This is the number of subjects who discontinued the i.v. selexipag treatment due to prostacyclin-associated adverse events (headache, diarrhea, nausea, vomiting, jaw pain, myalgia, pain in the extremity, flushing and arthralgia).|From Day 2 to Day 3|iv safety analysis set including all enrolled subjects who received at least one dose of intravenous selexipag during period 2|||Participants|||Count of Participants
2535950|NCT03187678|Primary|Number of Participants With Adverse Event Related to Injection Site Reactions|This is the number of participants with at least one clinically significant reaction at the injection site (e.g., erythema/redness, tenderness, swelling, induration, hemorrhage at the injection site) occurring on the days of intravenous (iv) selexipag injection.|From Day 2 to Day 3|iv safety analysis set including all enrolled subjects who received at least one dose of intravenous selexipag during Period 2|||Participants|||Count of Participants
2535951|NCT03187678|Primary|Number of Participants With Prostacyclin-associated Adverse Events|Prostacyclin-associated AE include headache, diarrhea, nausea, vomiting, jaw pain, myalgia, pain in the extremity, flushing and arthralgia.|From Day 1 to Day 37|Safety analysis set including all enrolled subjects who received at least one dose of Uptravi or intravenous selexipag during any of the study periods|||Participants|||Count of Participants
2535952|NCT03187678|Primary|Number of Participants With at Least One Adverse Event (AE)|AE is any untoward medical event that occurs in a participant during the course of the study whether or not considered by the investigator as related to the study treatment.|From Day 1 to Day 37|Safety analysis set including all enrolled subjects who received at least one dose of Uptravi or intravenous selexipag during any of the study periods|||Participants|||Count of Participants
2545583|NCT02940327|Primary|CD64/163|Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.|24 hours after ECMO commencement||||percentage change||Standard Deviation|Mean
2535953|NCT03187197|Secondary|Description of PACT-Q1 Items for Patients in Cohort B at Baseline|The PACT-Q1 was composed of a single dimension (7 items), covering the expectations of patients regarding their anticoagulant treatment, and was to be administered before treatment initiation. The 7 items were: Q1: How confident are you that your anticoagulant treatment will prevent blood clots? Q2: Do you expect that your anticoagulant treatment will relieve some of the symptoms you experience? Q3: Do you expect that your anticoagulant treatment will cause side effects such as minor bruises or bleeding? Q4: How important is it for you to have an anticoagulant treatment that is easy to take? Q5: How concerned are you about making mistakes when taking your anticoagulant treatment? Q6: How important is it for you to take care of your anticoagulant treatment by yourself? Q7: How concerned are you about how much you pay for your anticoagulant treatment? Responses ranged from 1 (Not at all) to 5 (Extremely/Completely/Very much).|Baseline|FAS|||Units on scale||Standard Deviation|Mean
2535954|NCT03187197|Secondary|Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment|The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores were more favorable. The two dimension scores were presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).|Visit 2 (30-45 days after initiation on Pradaxa®) and Visit 3 (150-210 days after initiation on Pradaxa®).|FAS|||Units on scale||Standard Deviation|Mean
2535955|NCT03187197|Primary|Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups|The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores were more favorable. The two dimension scores were presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching (PSM) method was used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group was summarized and used for comparison.|Visit 2 (30-45 days after initiation on Pradaxa® or VKA) and Visit 3 (150-210 days after initiation on Pradaxa® or VKA).|FAS|||Units on Scale||Standard Deviation|Mean
2535956|NCT03187197|Primary|Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment|The PACT-Q was a self-administered questionnaire which was developed as a means to investigate patients´ satisfaction with anticoagulant treatment and treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). Items for convenience and for burden of disease and treatment were reversed(reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score (CDS). Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores were more favorable. The two dimension scores were presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).|Baseline, Visit 2 (30-45 days after initiation on Pradaxa®), Visit 3 (150-210 days after initiation on Pradaxa®).|FAS|||Units on Scale||Standard Deviation|Mean
2535957|NCT03185481|Secondary|Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, III, IV, and Total Score|The total MDS-UPDRS score developed by the Movement Disorder Society is the most common method of evaluating the severity of Parkinson's Disease (PD). Part I assesses non motor experiences of daily living(range 0-52).Part II assesses motor experiences of daily living(0-52). Part III assesses the motor signs of PD.Part IV assesses motor complications, dyskinesias, and motor fluctuations(0-24).Total Score:The sum of Parts I, II, III, and IV.Each question is anchored with five responses:0=normal, 1=slight, 2=mild, 3= moderate, 4=severe.Higher part and total scores indicate more severe signs of PD.There are four subscales in Part III:the tremor subscale(range 0-36),the rigidity subscale(0-20),the bradykinesia subscale(0-36),the postural instability and gait disorder (PIGD) subscale(0-12).|Baseline to last visit after termination (up to approximately 3 months)|The study population included all participants who received at least 1 dose of study medication during the study period.|||Units on a scale||Full Range|Median
2535958|NCT03185481|Secondary|Change From Baseline for Hauser Participant Diary Data in Daily ON Time Without Troublesome Dyskinesia|"Available diaries are designed to record participant motor state for half hour intervals. These diaries are a way for participants to assess their own health status without clinician bias or interpretation. ON time is defined as the time when medication is providing benefit with regard to mobility, slowness, and stiffness. ON time can be classified as associated with or without troublesome dyskinesia that interfere with activities of daily living. ON time without dyskinesia and on time with non troublesome dyskinesia are generally considered to be good time."|Baseline, Day 21 and Day 35|The study population included all participants who received at least 1 dose of study medication during the study period.|||Hours||Standard Deviation|Mean
2535959|NCT03185481|Secondary|Change From Baseline for Hauser Participant Diary Data in Daily ON Time With Troublesome Dyskinesia|"Available diaries are designed to record participant motor state for half hour intervals. These diaries are a way for participants to assess their own health status without clinician bias or interpretation. ON time is defined as the time when medication is providing benefit with regard to mobility, slowness, and stiffness. ON time can be classified as associated with or without troublesome dyskinesia that interfere with activities of daily living.It has been demonstrated that ON time with troublesome dyskinesia are generally considered by participants to be bad time with regard to motor function."|Baseline, Day 21 and Day 35|The study population included all participants who received at least 1 dose of study medication during the study period.|||Hours||Standard Deviation|Mean
2535960|NCT03185481|Secondary|Change From Baseline for Hauser Participant Diary Data in Daily OFF Time|"Available diaries are designed to record participant motor state for half hour intervals. These diaries are a way for participant to assess their own health status without clinician bias or interpretation. In participant diaries, OFF time is defined as a period when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness. During this period, Parkinson's Disease (PD) participants experience relatively poor overall function with worsening of tremor, rigidity, balance, or bradykinesia."|Baseline, Day 21 and Day 35|The study population included all participants who received at least 1 dose of study medication during the study period.|||Hours||Standard Deviation|Mean
2535961|NCT03185481|Primary|Number of Participants With Benzodiazepine Discontinuation Symptoms Based on Physician Withdrawal Checklist (PWC-20)|The PWC-20 is a physician-completed, 20-item reliable and sensitive instrument for the assessment of benzodiazepine discontinuation symptoms, including anxiety and nervous, depersonalization and derealization, diarrhea, diaphoresis, difficulty concentrating and remembering, dizziness-lightheadedness, depression, fatigue, lethargy and lack of energy, headaches, increased acuity for sound, smell, touch, or pain, insomnia, irritability, loss of appetite, muscle aches or stiffness, nausea-vomiting paresthesias, poor coordination, restlessness and agitation, tremor-tremulousness, and weakness. Summaries of the count of participants experiencing symptoms and severity listed in the PWC-20 were provided.|At last visit|The population for PWC-20 included participants who completed study treatment and who participated the first visit of follow-up|||Participants|||Count of Participants
2535962|NCT03185481|Primary|Number of Participants With Worsening Suicidality and New Onset Suicidality|The Columbia Suicide Severity Rating Scale (C-SSRS) is an interview based rating scale to systematically assess suicidal ideation and suicidal behavior. At each suicidality assessment, participants felt to have significant suicidal ideation with actual plan and intent or suicidal behavior, must be evaluated by a clinician/mental health professional (MHP) skilled in the evaluation of suicidality in the participants by virtue of training or experience who determined if it is safe for the participants to participate/continue in the trial. The denominator used in the percentages was the number of participants assessed for suicidality or worsening, the denominator included the subset of participants who had any level of suicidality reported at baseline. For new onset, the denominator included the subset of participants with no suicidality reported at baseline.|Baseline to last visit after termination (up to approximately 3 months)|The study population included all participants who received at least 1 dose of study medication during the study period.|||Participants|||Count of Participants
2535963|NCT03185481|Primary|Number of Participants With Electrocardiogram Data Meeting Pre-defined Criteria|PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization), QRS duration (time from Q wave to the end of S wave, corresponding to ventricle depolarization), QT interval (time from the beginning of Q wave to the end of T wave) and QTcF interval ( QT interval corresponding to electrical systole corrected for heart rate using Fridericia's formula) are summarized. Number of participants with ECG findings meeting the following criteria is presented: (1) PR interval >=300 msec; (2) QRS duration >=140 msec; (3) QT interval >= 500; (4) QTcF interval: 450 to <480 msec; (5) QTcF interval: 480 to <500 msec; (6) QTcF interval >=500 msec.|Baseline to last visit after termination (up to approximately 3 months)|The study population included all participants who received at least 1 dose of study medication during the study period.|||Participants|||Count of Participants
2535964|NCT03185481|Primary|Number of Participants With Vital Signs Data of Orthostatic Hypotension Meeting Pre-defined Criteria|Orthostatic hypotension was defined as a decrease of >=20 mmHg for systolic blood pressure (SBP) or >=10 mmHg for diastolic blood pressure (DBP) 2 minutes after standing from a supine position.|Baseline to last visit after termination (up to approximately 3 months)|The study population included all participants who received at least 1 dose of study medication during the study period.|||Participants|||Count of Participants
2535965|NCT03185481|Primary|Number of Participants With Vital Signs Data Meeting Pre-defined Criteria|Number of participants with vital signs findings meeting the following criteria is presented:(1) standing DBP increase from baseline>= 20 mm Hg; (2) standing SBP increase from baseline>= 30 mm Hg; (3) supine DBP increase from baseline >=20 mm Hg; (4) supine SBP increase from baseline >=30 mm Hg; (5)standing DBP decrease from baseline>= 20 mm Hg; (6) standing SBP decrease from baseline>= 30 mm Hg; (7) supine DBP decrease from baseline >=20 mm Hg; (8) supine SBP decrease from baseline >=30 mm Hg.|Baseline to last visit after termination (up to approximately 3 months)|The study population included all participants who received at least 1 dose of study medication during the study period.|||Participants|||Count of Participants
2535966|NCT03185481|Primary|Number of Participants With Abnormalities in Laboratory Test (Without Regard to Baseline Abnormality)|Laboratory tests included hematology(hemoglobin,hematocrit,red and white blood cell count,mean corpuscular volume,mean corpuscular hemoglobin,mean corpuscular hemoglobin concentration,platelet count,neutrophils,eosinophils,monocytes, basophils,lymphocytes), chemistry(blood urea nitrogen/urea and creatinine,fasting glucose, calcium,sodium,potassium, chloride,total carbon dioxide,aspartate and alanine aminotransferase,total bilirubin,alkaline phosphatase,uric acid,albumin,total protein),urinalysis(pH,qualitative glucose protein,blood,ketones,nitrites,leukocyte esterase,urobilinogen,urine bilirubin,microscopy,specific gravity,urine creatinine),other tests(urine drug screen,follicle stimulating hormone,anti neutrophil cytoplasmic antibody panel,qualitative antinuclear antibody,fibrinogen,C reactive protein,erythrocyte sedimentation rate,C3, C4, CH50/CH100,rheumatoid factor,immunoglobulin panel,if anti- neutrophil cytoplasmic antibody positive:proteinase 3 Ab,myeloperoxidase Ab tests).|Baseline to last visit after termination(up to approximately 3 months)|The study population included all participants who received at least 1 dose of study medication during the study period.|||Participants|||Count of Participants
2535985|NCT03184441|Primary|Safety of Use of the Premie Pouch in VLBW Infants|Frequency of participants with adverse events reported using the Premie Pouch Adverse Event Data Collection Tool.|From date of enrollment to date of study completion (range 19-47 days)|Participants with adverse events|||participants|||Number
2535986|NCT03184428|Secondary|Correlation Coefficient Between Capsulotomy Rate and Parameters|"Correlation coefficients between capsulotomy rate and patient parameters:~age~gender,~and surgical parameters:~cutting length,~core hardness,~duration of whole operation,~time of phaco-emulsification,~phaco-energy,~phaco-machine,~combination with other operation,~surgeon,~power of IOL."|up to 8 years||||Correlation coefficient|eyes||Number
2535967|NCT03185481|Primary|Number of Participants With Clinically Significant Findings in Neurological Examination|The full neurological examination included assessment of the visual fields and of the right and left optic fundus; cranial nerves; mental state; muscle strength and tone, abnormal movements; deep tendon reflexes; sensory exam, coordination, gait and station. Higher cortical and motor function was considered part of the complete neurological exam. The brief neurological exam included observation for cerebellar (intention) tremor and for non cerebellar tremors (eg, resting or positional), finger to nose, heel to shin, Romberg, gait and tandem walking, positional and gaze evoked nystagmus. The clinical significance was determined by the investigator.|Baseline to last visit after termination (up to approximately 3 months)|The study population included all participants who received at least 1 dose of study medication during the study period and had a post-baseline neurological examination.|||Participants|||Count of Participants
2535968|NCT03185481|Primary|Number of Participants With Clinically Significant Findings in Physical Examination|A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems. The clinical significance was determined by the investigator.|Baseline to last visit after termination (up to approximately 3 months)|The study population included all participants who received at least 1 dose of study medication during the study period and had a post-baseline physical examination.|||Participants|||Count of Participants
2535969|NCT03185481|Primary|Number of Participants With Treatment-Emergent Adverse Events (Treatment Related)|An adverse event (AE) is any untoward medical occurrence in a study participant administered a product or medical device. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE).|Baseline to last visit after termination (up to approximately 3 months)|The study population included all participants who received at least 1 dose of study medication during the study period.|||Participants|||Count of Participants
2535970|NCT03185481|Primary|Number of Participants With Treatment-Emergent Adverse Events (All Causalities)|An adverse event (AE) is any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE).|Baseline to last visit after termination (up to approximately 3 months)|The study population included all participants who received at least 1 dose of study medication during the study period.|||Participants|||Count of Participants
2535971|NCT03185455|Secondary|Patient Satisfaction|Patient who would recommend the program to a family or friend as per the Patient Satisfaction Survey completed at 2 weeks postpartum.|2 weeks postpartum|The data population analyzed in the Remote Surveillance Arm included only those who completed the satisfaction survey. Participants in the standard of care arm were not eligible to complete the Patient Satisfaction Survey since they did not receive the intervention.|||Participants|||Count of Participants
2535972|NCT03185455|Secondary|Number of Participants With Hypertension Related Readmission Within 2 Weeks Postpartum|Number of participants with hypertension related readmission within 2 weeks postpartum|2 weeks postpartum||||Participants|||Count of Participants
2535973|NCT03185455|Secondary|Number of Participants Who Required Additional ER or Office Visits for Hypertension (Not Resulting in Readmission) Within 2 Weeks Postpartum|Number of participants who required additional ER or office visits for hypertension (not resulting in readmission) within 2 weeks postpartum|2 weeks postpartum||||Participants|||Count of Participants
2535974|NCT03185455|Secondary|Number of Participants Who Required Antihypertensive Medication Initiation or Dose Adjustment Within 2 Weeks Postpartum|Number of participants who required antihypertensive medication initiation or dose adjustment within 2 weeks postpartum|2 weeks postpartum|Only women who attended the office visit were analyzed in the standard of care group|||Participants|||Count of Participants
2535975|NCT03185455|Primary|Number of Participants Whose Blood Pressure Was Assessed in the First Ten Days Following Discharge|the percentage of patients in which a single blood pressure is obtained in the first 10 days following discharge. Within the texting group, the percentage of patients in whom blood pressures values are obtained at 72 hours and 7-10 days postpartum, in accordance with American College of Obstetricians and Gynecologists recommendations, will be assessed as well.|10 days postdischarge||||Participants|||Count of Participants
2535976|NCT03185182|Secondary|Number of Participants Diagnosed With Non-ccRCC That Display Ioflupane I123-negativity in Tumors Detected Via CT-scan|Ioflupane I123 displays no positive signal in lesions identifies by CT in patients with tumors classified as non-clear cell renal cell carcinoma|Through study completion for each participant, an average of 3 months|Patients with non-ccRCC as verified by pathologist|||Participants|||Count of Participants
2535977|NCT03185182|Primary|Number of Participants That Display Ioflupane-positivity in Tumors Detected Via CT-scan|The primary endpoint is to investigate if tumors detected with CT display Ioflupane positivity in patients with verified clear cell renal cell carcinoma (ccRCC). Ioflupane signal was considered positive when intensity was >3 times background signal in anatomic position identified as a lesion by CT-scan|Through study completion for each participant, an average of 3 months||||Participants|||Count of Participants
2535978|NCT03184701|Post-Hoc|Hospital Readmissions at 30 Days|Number of admissions to the hospital|30 days|||||||
2535979|NCT03184701|Primary|Patient Satisfaction|Number of Participants reporting Satisfaction with Device|3 months|All participants who completed the end of study survey (at 3 months) are included.|||Participants|||Count of Participants
2535980|NCT03184519|Primary|Number of Participants With Early Detection of Pregnancy|Detection of Pregnancy on earlier dates (before day-11 after Embrio transfer)|One month|13 patients were excluded from analysis|||Participants|||Count of Participants
2535981|NCT03184441|Secondary|Premie Pouch Ease of Use|This the percentage or nurses that found the Premie Pouch device easy to use.|From date of enrollment to date of study completion (range 19-47 days)||||Participants|||Count of Participants
2535982|NCT03184441|Secondary|Number of Participants With Normal Cranial Symmetry|To assess for cranial asymmetry of the head shape at study completion, the right anterior-posterior measures and left anterior-posterior measures of infant's head shapes were obtained. Cranial symmetry was defined as less than 8mm difference in the right and left anterior-posterior measures.|Cranial symmetry at study completion|Normal Cranial Symmetry|||Participants|||Count of Participants
2535987|NCT03184428|Primary|Percentage of Eyes With Posterior Capsule Opacification Following Implantation of IOL 313 up to 8 Years|"In order to find out whether patients with cataract surgery are affected by lens opacification, we assessed whether a Nd:YAG laser capsulotomy was performed for treatment.~For this purpose, the patient files were spotted first. Those who had no recent findings were asked in writing if and when a laser treatment was performed. In the absence of feedback and in case of uncertain or unusable written answer, a telephone consultation with the patient was made. If sufficient information was not available afterwards, the ophthalmologist was asked for information (by phone, by written request or by collecting the data on site in the practices)."|up to 8 years||||percentage of eyes|eyes||Number
2535988|NCT03184077|Secondary|Overall Sexual Function|"Level of sexual desire or interest on a scale of 1-5, with 5 being the highest level of interest~Scale used - Female Sexual Function Index -6 where 0 indicates no sexual activity, 1 indicates a worse outcome and 5 indicates a better outcome.~The scale assesses sexual desire, arousal, lubrication, orgasm, sexual satisfaction and sexual pain.~A score of 1 indicates very low desire, arousal, almost never or never becoming lubricated or achieving orgasm, being very dissatisfied with sexual life and almost always or always having pain with intercourse.~A score of 5 indicates very high desire, arousal, almost always or always becoming lubricated or achieving orgasm, being very satisfied with sexual life and almost never or never having pain with intercourse."|3 months||||units on a scale||Standard Deviation|Mean
2535989|NCT03184077|Secondary|Postpartum Pain|To assess overall perineal pain using a visual analog scale on a range of 0-10, with 0 being no pain and 10 being worst imaginable pain Scale used - Pain Numeric Rating Scale. A minimal score of 0 indicates no pain whereas a maximums core of 10 indicates the worse imaginable pain.|6 weeks postpartum||||units on a scale||Standard Deviation|Mean
2535990|NCT03184077|Primary|Rates of Dyspareunia|"To evaluate the rates of dyspareunia with rapidly absorbing polyglactin 910 compared to poliglecaprone 25 using a validated sexual function questionnaire, with higher scores indicating greater discomfort or pain.~Scale used - Female Sexual Function Index -6 where 0 indicates no sexual activity, 1 indicates a worse outcome and 5 indicates a better outcome.~The scale assesses sexual desire, arousal, lubrication, orgasm, sexual satisfaction and sexual pain.~A score of 1 indicates very low desire, arousal, almost never or never becoming lubricated or achieving orgasm, being very dissatisfied with sexual life and almost always or always having pain with intercourse.~A score of 5 indicates very high desire, arousal, almost always or always becoming lubricated or achieving orgasm, being very satisfied with sexual life and almost never or never having pain with intercourse."|3 months postpartum||||units on a scale||Standard Deviation|Mean
2535991|NCT03183869|Secondary|Evaluate Treatment Safety: MRI to Access Subclinical Disease Activity|MRI to access subclinical disease activity|Baseline, 6 months and 12 months|||||||
2535992|NCT03183869|Secondary|Evaluate Treatment Clinical Safety: Neurological Exam Using the Expanded Disability Status Scale|Neurological exam using the Expanded Disability Status Scale|Monthly for 6 months|||||||
2535993|NCT03183869|Secondary|Evaluate Effect of Fecal Microbial Transplantation in Gut Permeability|Urinalysis to evaluate lactulose and mannitol levels|Baseline, 6 months, 12 months|||||||
2535994|NCT03183869|Secondary|Evaluate Effect of Fecal Microbial Transplantation in Gut Microbiome|PCR (polymerase chain reaction) to assess blood DNA bacteria|Monthly for 6 months|||||||
2535995|NCT03183869|Primary|Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients|Luminex test to evaluate the levels of 25 cytokines in peripheral blood pre-fecal transplant and post fecal transplant. Due to early termination of the trial, we didn't meet the number of participants required for statistical analysis; therefore, we analyzed the data pre and post FMT, rather than early and late intervention groups as originally planned. Due to the small sample size there was a large variation between cytokine levels of each participant for pre and post FMT, resulting in large standard deviations.|Within 6 months||||ng/mL||Standard Deviation|Mean
2535996|NCT03183518|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge Phase at Week 6 48 (±2) Hours, Post Patch Removal|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Week 6, 48 (±2) hours, post patch removal|The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2535997|NCT03183518|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge Phase At Week 6 24 (±2) Hours Post Patch Removal|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Week 6 24 (±2) hours post patch removal|The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536695|NCT03159299|Secondary|Change in Baseline Systolic and Diastolic Blood Pressure From Baseline|Systolic and diastolic BP will be measured according to practice standards. Two readings separated by 1 minute will be averaged|3 months|||||||
2535998|NCT03183518|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge Phase At Week 6 (After 30 Minutes [Maximum 1 Hour], Post Patch Removal)|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Week 6 (after 30 minutes [maximum 1 hour], post patch removal)|The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2535999|NCT03183518|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 19|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Day 19|The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536000|NCT03183518|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 18|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Day 18|The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536001|NCT03183518|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 16|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Day 16|The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536002|NCT03183518|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 15|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Day 15|The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536035|NCT03181594|Secondary|Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)|The RQLQ is a validated quality of life questionnaire that evaluates functional problems associated with rhinitis. The questionnaire assess 7 domains: activities, sleep, nose symptoms, eye symptoms, non nose/eye symptoms, practical problems, and emotional function. Each question is scores on a 7-point scale (0=not impaired at all, 6=severely impaired). A domain and total scores are based on the mean of all answered items in that domain resulting in domain or total scores ranging from 0 to 6. An average change on 0.5 or more is considered a minimal clinically important difference.|90 days post treatment|All treated participants with 90-day follow-up.|||score on a scale||Standard Deviation|Mean
2536036|NCT03181594|Primary|Device- and/or Procedure-related Serious Adverse Events|Safety will be evaluated based on the frequency of device- and/or procedure-related serious adverse events|90 days post treatment|All treated participants.|||events|||Number
2536003|NCT03183518|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 12|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Day 12|The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536004|NCT03183518|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 11|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Day 11|The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536005|NCT03183518|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 9|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Day 9|The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536006|NCT03183518|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 8|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Day 8|The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536007|NCT03183518|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 5|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Day 5|The ITT (N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536037|NCT03181594|Primary|Change From Baseline in Symptom Severity|Effectiveness will be assessed by the mean change in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual patient-rated symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, and 3=Severe. The rTNSS has a possible score of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 24 hours.|90 days post treatment|All treated participants with 90-day follow-up.|||score on a scale||Standard Deviation|Mean
2536182|NCT03177603|Secondary|Plasma Clearance (CL) of GSK2586881|Blood samples were collected at indicated time points for evaluation of CL. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose (Day 1) and 0.08, 0.5, 1, 2, 4, 8 and 24 hours post-dose (Day 1)|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2536008|NCT03183518|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 4|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Day 4|The Intent to treat (ITT, N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536009|NCT03183518|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 2|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Day 2|The Intent to treat (ITT, N=36) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536010|NCT03182933|Secondary|Quadriceps Strength|Quadriceps Strength is measured in pounds of force using the kiio device, reported as the highest value of 3 collected.|24 hours||||Pounds of Force||Standard Deviation|Mean
2536011|NCT03182933|Secondary|Number of Participants Who Experienced Nausea|Post operative nausea and vomiting as documented in the PACU and volunteered in an over the phone interview|Day 0, Day 1, Day 2, Day 3||||Participants|||Count of Participants
2536012|NCT03182933|Secondary|Opioid Consumption in Morphine Equivalents|Total opioid consumption will be measured in all patients over the course of 3 days and converted to oral morphine equivalents so that it can be statistically compared.|Day 0 (OR), Day 0 (PACU), Day 1, Day 2, Day 3||||Morphine equivalents||Standard Deviation|Mean
2536013|NCT03182933|Secondary|Pain Scores|Visual Analog Scores on a scale of 1-10, where 1 is pain free and 10 is the most pain.|Day 0, Day 1, Day 2, Day 3||||score on a scale||Standard Deviation|Mean
2536014|NCT03182933|Primary|10 Meter Walk Test|Time to comfortably walk 10 meters as deemed safe by physical therapy|24 hours||||seconds||Standard Deviation|Mean
2536015|NCT03182920|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Lasmiditan|Area under the concentration versus time curve from zero to infinity|Day 1:Predose,0.5, 1, 1.5,2, 2.5, 3, 4,6, 8, 12 hours; Day 2: 24,36 hours; Day 3:48 hours|All participants who received at least one dose of study drug.|||Nanograms*hour per Millilitre (ng.h/mL)||Geometric Coefficient of Variation|Geometric Mean
2536016|NCT03182920|Primary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan|Maximum Observed Drug Concentration (Cmax) of Lasmiditan.|Day 1:Predose,0.5, 1, 1.5,2, 2.5, 3, 4,6, 8, 12 hours; Day 2: 24,36 hours; Day 3:48 hours|All participants who received at least one dose of study drug.|||Nanograms Per Millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2536017|NCT03182738|Other Pre-specified|Score on Fried's Frailty Phenotype|Fried's frailty phenotype is a combination of five scores: weight loss in the last year, exhaustion, physical activity, walk time for a 15 foot interval, and grip strength. The frailty condition is defined as meeting the definition of frailty for at least 3 of the listed scores.|Baseline, 3 months, and 6 months|Not all participants showed up to their 3-month and 6-month follow-up visit and therefore did not complete any of the frailty measures. These individuals were excluded from the analysis.|||Participants|||Count of Participants
2536018|NCT03182738|Other Pre-specified|Score of the VAS|The Visual Analogue Scale (VAS) measures adherence to antiretroviral therapy (ART). VAS asks subjects to indicate a point on a line that shows their best guess about how much of each drug they have taken. 0% means they have taken no drug, 50% means they have taken half their drugs, and 100% means they have taken every single dose.|Baseline, 3 months, and 6 months|Not all participants completed the scale at 3 months and 6 months because they did not show up to their 3-month and 6-month follow-up visit. Some participants also did not answer the question and left it blank, thus excluded from the analysis.|||percentage of medication||Standard Deviation|Mean
2536019|NCT03182738|Other Pre-specified|Score on Engagement With Health Care Provider Scale|Engagement with Health Care Provide scale is a 13-item scale in which subjects rate their interactions with their health care providers on a four-point scale with 1=always true and 4=never true. A total score can be calculated to create a possible range of 13-52. A low score (closer to 13) indicates greater provider engagement between the patient and provider.|Baseline, 3 months, and 6 months|Not all participants completed the scale at 3 months and 6 months because they did not show up to their 3-month and 6-month follow-up visit. Some participants also did not answer all of the questions within the scale to produce a score between 13 and 52, and were thus excluded from the analysis.|||score on a scale||Standard Deviation|Mean
2536020|NCT03182738|Other Pre-specified|Change in Score on SF-12|12-Item Medical Outcomes Study Short Form (SF-12) is a health survey to measure health-related quality of life.|3 months and 6 months|||||||
2536058|NCT03180801|Secondary|Duration of Influenza Symptoms|Subjects were assessed by the physician whilst under quarantine post-inoculation. The number of days subjects experienced influenza symptoms was recorded.|from the evening of Day 1 post-inoculation to the morning of Day 7 (last timepoint before expected quarantine discharge)|ITT|||days||Standard Error|Mean
2536021|NCT03182738|Secondary|Score on Patient-Reported Outcomes Measurement Information System® (PROMIS)-29|The PROMIS-29 includes seven health related quality of life domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain), and the pain domain has two subdomains (interference and intensity). Each of the 7 domains has four 5-level items (i.e., 16 decrements each). In addition to these items, pain intensity is assessed using a single 11-point numeric rating scale anchored between no pain (0) and worse imaginable pain. Raw scores, except pain intensity, are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. T-scores can be estimated using scoring tables listed in the PROMIS manuals. A higher PROMIS T-score implies more of the concept being measured; i.e., a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates more severe depressive symptoms.|Baseline, 3 months, and 6 months|Not all participants completed the scale at 3 months and 6 months because they did not show up to their 3-month and 6-month follow-up visit. Some participants also did not answer all of the questions within the scale to produce a valid t-score, and were thus excluded from the analysis.|||T-Score||Standard Deviation|Mean
2536022|NCT03182738|Primary|Symptom Burden Score|The Symptom Burden Score is an expanded version of the 20-item HIV symptom index. The score is calculated for the 28 most common symptoms in persons living with HIV. Each symptom is given a score ranging from 0 to 4 with the scores indicating the following: 0 (not experienced) , 1 (It doesn't bother me), 2 (It bothers me a little), 3 (It bothers me), or 4 (It bothers me a lot). The higher the score (closer to 4), the greater the symptom burden (worse outcome).|Baseline, 3 months and 6 months; period 1 = 1-6 weeks (baseline), period 2 = 6-18 weeks (3 months), period 3 = >18 weeks (6 months)|The statistical analysis defined the time points into 3 periods to correlate with the baseline, 3-month, and 6-month visits. Not all participants completed the symptom burden scale and therefore did not align within the 3 designated periods.|||score on a scale||Standard Deviation|Mean
2536023|NCT03182582|Secondary|Percent Change in Wound Size - 1 Week Post-debridement|The mean percent change in wound size 1-week post-laser debridement was -20.8% ± 80.1%, as compared with -36.7% ± 54.3% 1-week post-sharp debridement (p = 0.6).|1 week following respective procedure||||percent change||Standard Deviation|Mean
2536024|NCT03182582|Secondary|Percent Change in Wound Size- Immediately Post-debridement|The mean wound size increased immediately after debridement in both Groups, compared to the mean wound size before the debridement.|Day 1 of the respective procedure (immediately after)||||percent change||Standard Deviation|Mean
2536025|NCT03182582|Secondary|Patient Preference|Patient-reported preference of debridement type one week after study completion, reported as the count of participants that preferred either method.|2 weeks|Survey respondents were included in the analysis.|||Participants|||Count of Participants
2536026|NCT03182582|Primary|Bacterial Load Pre- and Post-Sharp Debridement|Bacterial load in wound as per tissue biopsy, pre- and post-sharp debridement|Day 1 of the sharp procedure (immediately before and after)||||Participants|||Count of Participants
2536027|NCT03182582|Primary|Bacterial Load Pre- and Post-Laser Debridement|Bacterial load in wound as per tissue biopsy, pre- and post-laser debridement. CFU = Colony Forming Units.|Day 1 of the laser procedure (immediately before and after)||||Participants|||Count of Participants
2536028|NCT03182582|Primary|Pain With Debridement|"Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is used in our study to measure the intensity or frequency of pain. We have used Numerical Rating Scale (NRS), variant of VAS, which is a validated, uni-dimensional measure of pain intensity reported on an 11-point numeric scale. The scores were reported from 0 to 10, with 0 representative of no pain, and 10 representative of the worst possible pain."|Day 1 of the respective procedure (immediately following)||||units on a scale||Standard Deviation|Mean
2536029|NCT03181724|Secondary|Change in Decision Regret Scale After 6 Weeks and 6 Months|Change in the Decision Regret Scale, which measures distress or remorse after a health care decision. The scale consists of 5 questions, which range from strongly agree to strongly disagree, scoring 0-100 with higher scores indicating more regret.|6 week and 6 month follow up||||units on a scale||Standard Error|Mean
2536030|NCT03181724|Secondary|11-point Ordinal Satisfaction Scale|The patient satisfaction scale measures how satisfied a patient is with their treatment for their thumb arthritis. Patients score satisfaction on a scale of 0 to 10, where 0 is not satisfied and 10 is extremely satisfied.|Day 1||||units on a scale||Standard Error|Mean
2536031|NCT03181724|Secondary|Consultation and Relational Empathy (CARE) Measure|The CARE measure is a 10-item questionnaire capturing patient perception of the physician's empathetic understanding under the office visit. Each item is rated on a 5-point Likert scale, yielding a total score from 0-50. A higher score indicates greater empathy.|Day 1||||units on a scale||Standard Error|Mean
2536032|NCT03181724|Secondary|Patient Health Questionnaire-2 (PHQ-2)|The PHQ-2 screens for depressive mood over the past 2 weeks. The score ranges from 0-6, where 0 is not at all depressed and 6 is major depression.|Day 1||||units on a scale||Standard Error|Mean
2536033|NCT03181724|Secondary|QuickDASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire|The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.|Day 1||||units on a scale||Standard Error|Mean
2536034|NCT03181724|Primary|Decision Conflict Scale (DCS)|This scale measures patients' perception of uncertainty in making health-related decisions and consists of 3 subscales: (1) uncertainty choosing between different options, (2) modifiable factors contributing to this uncertainty—feeling uninformed, unclear about personal values, and feeling unsupported, and (3) perceived effectiveness of the decision—making an informed and values-based choice and expressing satisfaction with the decision. We used the validated statement format Decisional Conflict Scale, consisting of 16 items with 5 response options. Total scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).|Day 1||||units on a scale||Standard Error|Mean
2536059|NCT03180801|Secondary|Peak Viral Load|Shedding is quantified by RT-PCR from nasal swabs taken twice daily (am/pm) during the quarantine period. Peak viral load is the highest recorded log10copy number/ml.|from the evening of Day 1 post-inoculation to the morning of Day 7 (last timepoint before expected quarantine discharge)|ITT|||log10copy number/ml||Standard Error|Mean
2536038|NCT03181503|Primary|Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Observed Data|"Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch."|Baseline, Week 4|ITT population included all randomized participants and were analyzed ‘as randomized’ regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
2536039|NCT03181503|Secondary|Percentage of Participants Achieving Investigator Global Assessment Success (Defined as IGA= 0 [Clear] or IGA = 1 [Almost Clear] With Two-point Improvement From Baseline) at Week 12|IGA is a 5-point scale used by the investigator or trained designee to evaluate the severity of the disease ranging from 0 to 4 where, 0 = clear, 1= almost clear, 2 = mild, 3 = moderate and 4 severe. IGA corresponds to the overall assessment of the severity of prurigo including presence of crust and nodules or skin bleeding. Higher score indicated greater severity of disease.|Week 12|ITT population included all randomized participants and were analyzed ‘as randomized’ regardless of the treatment they received.|||percentage of participants|||Number
2536040|NCT03181503|Secondary|Investigator Global Assessment (IGA) Score at Each Visit|IGA is a 5-point scale used by the investigator or trained designee to evaluate the severity of the disease ranging from 0 to 4 where, 0 = clear, 1= almost clear, 2 = mild, 3 = moderate and 4 severe. IGA corresponds to the overall assessment of the severity of prurigo including presence of crust and nodules or skin bleeding. Higher score indicated greater severity of disease.|Day 1 (Baseline), Weeks 4, 8, 12 and 18|ITT population included all randomized participants and were analyzed ‘as randomized’ regardless of the treatment they received. Here, 'n' (number analyzed) signifies number of participants evaluable for each time point.|||Units on a scale||Standard Deviation|Mean
2536041|NCT03181503|Secondary|Prurigo Activity Score (PAS) Item 6: Number of Participants With Defined Stages of Excoriation/Crusts and Healed Lesions at Each Visit|PAS includes 7-descriptive items; 1) lesions type (papules nodules/plaques/umbilicated ulcers/ulcers/hypo-/hyperpigmented maculae); 2) number (prurigo lesions on whole body); 3) distribution (disseminated/localized [only 1/2 areas affected]/neither of them); 4) affected areas (forearm/upper arm/lower and upper leg/trunk/head); 5) number of prurigo lesions in selected area; 6) activity (prurigo lesions with excoriations/crusts and healed prurigo lesions compared to all prurigo lesions) and 7) front and back, areas of marked monitor lesions to recognize on next visit. Item 6 has 5 stages (0-4) where each stage represents percentage of prurigo lesions with excoriations/crusts and healed prurigo lesions compared to all prurigo lesions: excoriations/crusts lesions; stage 0=0%, 1=1-25%, 2=26-50%, 3=51-75%, 4=76-100%; for healed lesions; stage 0=100%, 1=75-99%, 2=50-74%, 3=25-49%, 4=0-24%.|Day 1 (Baseline), Weeks 4, 8, 12 and 18|ITT population included all randomized participants and were analyzed ‘as randomized’ regardless of the treatment they received. Here 'n' (number analyzed) signifies number of participants evaluable at each time point for specified category.|||Participants|||Count of Participants
2536042|NCT03181503|Secondary|Prurigo Activity Score (PAS) Item 5: Overall Number of Prurigo Lesions at Week 12|PAS includes 7-descriptive items; 1) lesions type (papules nodules/plaques/umbilicated ulcers/ulcers/hypo-/hyperpigmented maculae); 2) number (prurigo lesions on whole body); 3) distribution (disseminated/localized [only 1/2 areas affected]/neither of them); 4) affected areas (forearm/upper arm/lower and upper leg/trunk/head); 5) number of prurigo lesions in selected area; 6) activity (prurigo lesions with excoriations/crusts and healed prurigo lesions compared to all prurigo lesions) and 7) front and back, areas of marked monitor lesions to recognize on next visit.|Baseline, Week 12|ITT population included all randomized participants and were analyzed ‘as randomized’ regardless of the treatment they received.|||Prurigo Lesions||Standard Error|Mean
2536043|NCT03181503|Secondary|Dynamic Pruritus Score (DPS) at 24, 48, and 72 Hours After First Injection and Before Second Injection (Week 4)|The 9-point DPS is a dynamic scale used by participants to evaluate the change of their pruritus compared with an earlier time point. The scale ranges from 0 (strongly worsened pruritus) to 8 ([almost] no pruritus anymore), including intermediate marks for slightly improved/worsened, moderately improved/worsened, and rather improved/worsened. Participants recorded their DPS score in their local language, and completed the assessment 24, 48 and 72 hours after the first injection at baseline and at week 4 before the second injection.|After 24, 48, 72 hours of first Injection and before second injection (Week 4)|ITT population included all randomized participants and were analyzed ‘as randomized’ regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.|||Units on a scale||Standard Deviation|Mean
2536044|NCT03181503|Secondary|Absolute Change From Baseline in Weekly Average of the Average Verbal Rating Scale Score at Each Visit Using LOCF Approach|"VRS consists of a list of adjectives describing different levels of symptom intensity used by participants to report intensity of their pruritus (itch) over last 24 hours. Participants marked on a 5-point VRS (0=no itch, 1=mild itch, 2=moderate itch, 3=severe itch, 4=very severe itch), a response that best described their pruritus intensity in last 24 hours. Participants were asked following questions in their local language: 1) For average itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your itch overall during previous 24 hours?; 2) For maximum itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your worst itch during previous 24 hours?. Where, higher score indicated very severe itch. Missing values including those who took rescue medication were replaced by LOCF approach."|Baseline, Weeks 1, 2, 4, 8, 12,16 and 18|ITT population included all randomized participants and were analyzed ‘as randomized’ regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.|||Units on a scale||Standard Deviation|Mean
2536045|NCT03181503|Secondary|Percent Change From Baseline in Weekly Average of the Average Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach|"VRS consists of a list of adjectives describing different levels of symptom intensity used by participants to report intensity of their pruritus (itch) over last 24 hours. Participants marked on a 5-point VRS (0=no itch, 1=mild itch, 2=moderate itch, 3=severe itch, 4=very severe itch), a response that best described their pruritus intensity in last 24 hours. Participants were asked following questions in their local language: 1) For average itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your itch overall during previous 24 hours?; 2) For maximum itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your worst itch during previous 24 hours?. Where, higher score indicated very severe itch. Missing values including those who took rescue medication were replaced by LOCF approach."|Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18|ITT population that included all randomized participants and were analyzed ‘as randomized’ regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.|||percent change||Standard Deviation|Mean
2536046|NCT03181503|Secondary|Absolute Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale Score at Each Visit Using LOCF Approach|"VRS consists of a list of adjectives describing different levels of symptom intensity used by participants to report intensity of their pruritus (itch) over last 24 hours. Participants marked on a 5-point VRS (0=no itch, 1=mild itch, 2=moderate itch, 3=severe itch, 4=very severe itch), a response that best described their pruritus intensity in last 24 hours. Participants were asked following questions in their local language: 1) For average itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your itch overall during previous 24 hours?; 2) For maximum itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your worst itch during previous 24 hours?. Where, higher score indicated very severe itch. Missing values including those who took rescue medication were replaced by LOCF approach."|Baseline, Weeks 1, 2, 4, 8, 12,16 and 18|ITT population included all randomized participants and were analyzed ‘as randomized’ regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.|||Units on a scale||Standard Deviation|Mean
2536047|NCT03181503|Secondary|Percent Change From Baseline in Weekly Average of the Peak of Pruritus Verbal Rating Scale (VRS) Score at Each Visit Using LOCF Approach|"VRS consists of a list of adjectives describing different levels of symptom intensity used by participants to report intensity of their pruritus (itch) over last 24 hours. Participants marked on a 5-point VRS (0=no itch, 1=mild itch, 2=moderate itch, 3=severe itch, 4=very severe itch), a response that best described their pruritus intensity in last 24 hours. Participants were asked following questions in their local language: 1) For average itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your itch overall during previous 24 hours?; 2) For maximum itch intensity: on a scale of 0-4, with 0 being 'no itch' and 4 being 'very severe itch', how would you rate your worst itch during previous 24 hours?. Where, higher score indicated very severe itch. Missing values including those who took rescue medication were replaced by LOCF approach."|Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18|ITT population included all randomized participants and were analyzed ‘as randomized’ regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.|||Percent change||Standard Deviation|Mean
2536048|NCT03181503|Secondary|Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach|"Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach."|Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18|ITT population included all randomized participants and were analyzed ‘as randomized’ regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.|||Units on a scale||Standard Deviation|Mean
2536049|NCT03181503|Secondary|Percent Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach|"Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach."|Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18|ITT population included all randomized participants and were analyzed ‘as randomized’ regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for each time point.|||Percent change||Standard Deviation|Mean
2536103|NCT03180619|Secondary|Percentage of Participants With Serological Response: Seroconversion to Anti-HBs in HBeAg-Positive Participants at Week 24|HBsAg seroconversion was defined as HBsAg loss and HBsAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.|Week 24|The Serologically Evaluable Full Analysis Set for HBsAg Loss/Seroconversion were analyzed.|||percentage of participants|||Number
2536050|NCT03181503|Secondary|Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach|"Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach."|Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18|ITT population included all randomized participants analyzed ‘as randomized’ regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.|||Units on a scale||Standard Deviation|Mean
2536051|NCT03181503|Secondary|Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Each Visit Using LOCF Approach|"Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach."|Baseline, Weeks 1, 2, 4, 8, 12, 16 and 18|ITT population included all randomized participants analyzed ‘as randomized’ regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for each time point.|||percent change||Standard Deviation|Mean
2536052|NCT03181503|Primary|Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale Score at Week 4 Using Multiple Imputation (MI) Method|"Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch. Multiple imputation generated twenty-five sets of data with missing values imputed from observed data using linear regression."|Baseline, Week 4|ITT population included all randomized participants and were analyzed ‘as randomized’ regardless of the treatment they received.|||Percent change||Standard Deviation|Mean
2536053|NCT03181503|Primary|Percent Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) Score at Week 4 Using Last Observation Carried Forward (LOCF) Approach|"Pruritus NRS is a scale used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. Participants completed the assessment once daily at home in the evening. Participants were asked the following questions in their local language: 1) For average itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch overall during the previous 24 hours?; 2) For maximum itch intensity: on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Where, higher score indicated worst imaginable itch. Missing values including those who took rescue medication were replaced by LOCF approach."|Baseline, Week 4|Intent-to-treat (ITT) population included all randomized participants and were analyzed ‘as randomized’ regardless of the treatment they received. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
2536054|NCT03181009|Primary|Change in Allergen-specific Serum IgG4 and IgE|Change in allergen-specific serum IgG4 and IgE from baseline to Week 18 (End of Study)|18 weeks||||Total serum IgE (kU/L)||Full Range|Median
2536055|NCT03180801|Secondary|Assessment of Self-reported Influenza Symptoms by FLU-PRO Questionnaire.|"FLU-PRO assesses 32 influenza symptoms. Subjects rate each symptom on a 5-point ordinal scale, with higher scores indicating a more frequent sign or symptom. For 27 of the items, the scale is as follows: 0 (Not at all), 1 (A little bit), 2 (Somewhat), 3 (Quite a bit), and 4 (Very much). For 5 items, severity is assessed in terms of numerical frequency, i.e., vomiting or diarrhea (0 times, 1 time, 2 times, 3 times, or 4 or more times); with frequency of sneezing, coughing, and coughed up mucus or phlegm evaluated on a scale from 0 (Never) to 4 (Always).The FLU-PRO total score is computed as a mean score across all 32 items comprising the instrument. Total scores can range from 0 (symptom free) to 4 (very severe symptoms)."|from Day 1 post-inoculation until the day 7.|ITT|||FLU-PRO total score||Standard Error|Mean
2536056|NCT03180801|Secondary|Peak Number of Symptoms Experienced Per Subject in a Single Day.|The highest level of the total sum of all upper and lower respiratory tract and systemic symptoms recorded on any day starting from the evening of Day 1 post-inoculation until the day of last symptom noted during the expected quarantine period (up to Day 7).|from the evening of Day 1 post-inoculation until the day of last symptom noted during the expected quarantine period (up to Day 7).|ITT|||number of symptoms||Standard Error|Mean
2536057|NCT03180801|Secondary|Number of Symptoms Experienced Per Subject Per Day.|Mean of total number of symptoms (upper and lower respiratory and systemic symptoms) experienced calculated as the total sum of symptoms experienced divided by the number of days in which symptoms were collected.|from the evening of Day 1 post-inoculation to the morning until the day of last symptom noted during the expected quarantine period (up tp Day 7)|ITT|||number of symptoms per day||Standard Error|Mean
2536104|NCT03180619|Secondary|Percentage of Participants With Serological Response: Loss of HBsAg in HBeAg-Positive Participants at Week 96||Week 96|||||||
2536105|NCT03180619|Secondary|Percentage of Participants With Serological Response: Loss of HBsAg in HBeAg-Positive Participants at Week 48||Week 48|||||||
2536060|NCT03180801|Other Pre-specified|Broadness of Protection|To determine whether the cellular responses induced by vaccination with FLU-v are able to recognize antigenically different strains of influenza (ie. H1N1, H3N2, H5N1) and in doing so demonstrating the broadness of the response. For this PBMCs from prevaccination, post-vaccination and post-challenge from subjects will be exposed in vitro to different influenza virus strains. Viral recognition by PBMCs will be assessed by measuring secretion of inflammatory cytokines and other inflammatory mediators using techniques such as multiplex ELISA.|At Screening (Day -90 to Day -43), Post-vaccination (Day -2/Day -1/Day 0) and post-influenza challenge (Day 35/Day 63)||2019-12-31|12/2019||||
2536061|NCT03180801|Other Pre-specified|Immunogenicity of FLU-v|To determine the antibody and cellular responses specific to FLU-v.|At Screening (Day -90 to Day -43), Post-vaccination (Day -2/Day -1/Day 0) and post-influenza challenge (Day 35/Day 63)||2019-12-31|12/2019||||
2536062|NCT03180801|Secondary|Total Viral Shedding (Area Under the Curve)|Shedding is quantified by RT-PCR from nasal swabs taken twice daily (am/pm) during the quarantine period. Plotting the log copy number/ml for each time point against time is done to calculate the area under the curve (AUC) using the trapezoidal rule.|from the evening of Day 1 post-inoculation to the morning of Day 7 (last timepoint before expected quarantine discharge)|ITT|||hours*log10copy number/ml||Standard Error|Mean
2536063|NCT03180801|Secondary|Viral Shedding Duration|Number of days with detectable viral shedding measured using the Luminex Respiratory Pathogen Panel test.|starting from evening of Day 1 post-inoculation up to Day 7.|ITT|||days||Standard Error|Mean
2536064|NCT03180801|Secondary|Number of Subjects With Detectable Viral Shedding and Number of Subjects With Recorded Influenza Symptoms During the Quarantine Period.|"Number of subjects experiencing at least one influenza symptom and at least two influenza symptoms.~Number of subjects with detectable shedding by RPP (Luminex) test from nasal swabs.~Number asymptomatic subjects with detectable virus by RPP (Luminex) test from nasal swabs."|Quarantine period from day 1 to day 7 post-inoculation.|ITT|||Participants|||Count of Participants
2536065|NCT03180801|Primary|Number of Subjects With Treatment Emergent Adverse Event Classified by Relatedness and Severity.|Number of subjects with one or more AE are reported by severity (mild, moderate and severe) and relatedness to vaccine or challenge virus inoculation (definitely, probably, possibly, unlikely, not related).|From the day of the first vaccination up to the end of the study on day +63.|Safety population|||Number of participants|||Number
2536066|NCT03180801|Primary|Number of Treatment Emergent Adverse Events (TEAEs) Per Subject.|To determine the number of TEAEs that were reported after the first administration of the vaccine until the end of the study (overall) and then separated into pre-inoculation (events reported from the time of first vaccination up to Day 0 prior to time of inoculation) and post-inoculation (Day 0 inoculation time through study completion).|From the first vaccination on day -43 to the last follow up visit on day 63.|Safety population|||Number of TEAEs per subject||Standard Error|Mean
2536067|NCT03180801|Primary|Number of Participants With Mild to Moderate Influenza Disease (MMID)|To determine the effect of FLU-v on reducing the incidence of Mild to Moderate Influenza Disease (MMID) defined as detectable viral shedding by Luminex Respiratory Pathogen Panel Test (RPP) in the presence of at least one influenza symptom.|From 24h post-viral inoculation (Day 1) until the end of the quarantine phase on Day 7|ITT includes those participants who received both vaccination and were challenged with the H1N1 influenza virus|||Participants|||Count of Participants
2536068|NCT03180645|Secondary|Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Day 15 and 29|TEWL measuring principle was based on water vapour gradient determination between two pairs of sensors (temperature and relative humidity) placed at different distances perpendicularly to the skin. Measurements were taken in triplicate and then an average (mean) reading was calculated on the left and right Sub-ocular/ Cheek Area directly from the corner of the eyes onto the middle of the cheekbone. A decrease in TEWL corresponds to an improved skin barrier function.|At Baseline, Day 15 and 29|Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points.|||gram (g)/meter^2 (m)/hour||Standard Deviation|Mean
2536069|NCT03180645|Secondary|Change From Baseline in Instrumental Cutometer Parameter R7, at Day 15 and 29|The Cutometer measures elasticity of the upper skin layer using negative pressure which deforms the skin mechanically. Negative pressure was created in the device and the skin was drawn into the aperture of the probe and after a defined time released again. Inside the probe, the penetration depth was determined by a non-contact optical measuring system. The light intensity varies due to the penetration depth of the skin. The resistance of the skin to the negative pressure (firmness) and its ability to return into its original position (elasticity) are displayed as curves (penetration depth in mm/time) in real time during the measurement. This measurement principle provides information about the elastic and mechanical properties of the skin surface and enables objective quantification of skin ageing. R7: Portion of the elasticity compared to the complete curve values.|At Baseline, Day 15 and 29|Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points.|||Ratio (unitless)||Standard Deviation|Mean
2536070|NCT03180645|Secondary|Change From Baseline in Instrumental Cutometer Parameters R5, at Day 15 and 29|The Cutometer measures elasticity of the upper skin layer using negative pressure which deforms the skin mechanically. Negative pressure was created in the device and the skin was drawn into the aperture of the probe and after a defined time released again. Inside the probe, the penetration depth was determined by a non-contact optical measuring system. The light intensity varies due to the penetration depth of the skin. The resistance of the skin to the negative pressure (firmness) and its ability to return into its original position (elasticity) was displayed as curves (penetration depth in mm/time) in real time during the measurement. This measurement principle provides information about the elastic and mechanical properties of the skin surface and enables objective quantification of skin ageing. R5 (net elasticity): the elastic portion of the suction part versus the elastic portion of the relaxation part.|At Baseline, Day 15 and 29|Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points.|||Ratio (unitless)||Standard Deviation|Mean
2536071|NCT03180645|Secondary|Percent Improvement From Baseline in Skin Texture Rankings Based on Lay Grader Assessment of High Resolution Images at Day 29|High resolution images of the left and right side of each participant's whole half-face were taken at baseline and Day 29. Each blinded image pair was randomly displayed on a color-calibrated screen and assessed by a panel of lay graders, who ranked each image based on texture, defined as pores, smoothness and unevenness, on a scale of: 1 = better; or 2 = worse (lower score indicated improvement). The total proportion of improvement (from all lay graders) on Day 29 than baseline is reported for this endpoint.|At Baseline and Day 29|Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available.|||Percent of improvement ratings||95% Confidence Interval|Number
2536072|NCT03180645|Secondary|Change From Baseline in Instrumental Corneometer Values, at Day 15 and 29|Measurement of Stratum Corneum (SC) hydration was performed by the electrical capacitance method with a Corneometer. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. An electric field was created between gold conductors to enable the dielectricity of the SC to be measured. Because the dielectricity varies as a function of the skin's water content, the SC moisturisation was measured. Higher value of corneometery indicates high moisture content.|At Baseline, Day 15 and 29|Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points.|||Instrumental units (I.U)||Standard Deviation|Mean
2536073|NCT03180645|Secondary|Change From Baseline in Clinical Fitzpatrick Wrinkle Score, at Day 15 and 29|A blinded, trained and qualified examiner performed Clinical Fitzpatrick Wrinkle Score assessments by visually grading the crow's feet area under standard conditions of illumination. Fitzpatrick Wrinkle Scores range between 1-9 where 1-3= Fine wrinkles, 4-6= Fine to moderate depth wrinkles, a moderate number of wrinkles, 7-9= Fine to deep wrinkles, numerous lines, with or without redundant skin folds. Low value indicated better results.|At Baseline, Day 15 and 29|Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points.|||Score on a scale||Standard Deviation|Mean
2536074|NCT03180645|Secondary|Change From Baseline in Stm (dermaTOP Parameters), at Day 15 and 29|Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. The 3D skin surface profile was calculated from the position of the fringes in combination with the Gray values of each pixel. From the captured 3D structure, roughness parameters were calculated. Stm was an average of the 5x5 sub-areas (peak to valley heights) local maximum: The surface was virtually divided into 25 sub-surfaces (5 rows, 5 columns); from each local surface the peak to peak height value is calculated; the average of the 25 peak to height values was Stm.|At Baseline, Day 15 and 29|Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points.|||µm||Standard Deviation|Mean
2536075|NCT03180645|Secondary|Change From Baseline in Sa (dermaTOP Parameters) at Day 15 and 29|Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. The 3D skin surface profile was calculated from the position of the fringes in combination with the Gray values of each pixel. From the captured 3D structure, roughness parameters were calculated. Sa was the arithmetic average of the absolute (non- signed) heights of the topography points. Sa was the 3D Area -Equivalent of 2D profile roughness parameter Ra.|At Baseline, Day 15 and 29|Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points.|||µm||Standard Deviation|Mean
2536076|NCT03180645|Secondary|Change From Baseline in Rz (a dermaTOP Parameter) at Day 15 and 29|Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Rz usually used for wrinkle assessments, representing the rough structure, such as wrinkles. Rz was an average of the 5 sub-profiles (peak to valley heights) local maximum. From each local profile the peak to peak height value is calculated; the average of the 5 peak to peak height values was Rz.|At Baseline, Day 15 and 29|Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points.|||µm||Standard Deviation|Mean
2536077|NCT03180645|Secondary|Change From Baseline in Ra (a dermaTOP Parameter), of Positive Control Treated vs. Untreated Side at Day 15 and 29|Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Ra is usually used for wrinkle assessments, representing the finer skin structure (Ra). Ra is the average deviation of the profile from the mean line (arithmetic mean of the absolute values of the point's heights).|At Baseline, Day 15 and 29|Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available. Here, number analyzed signifies number of participants who were evaluable at the specified time points.|||µm||Standard Deviation|Mean
2536078|NCT03180645|Secondary|Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated vs. Untreated Side at Day 15|Using fringe projection and optical triangulation techniques, the 3D surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Ra is usually used for wrinkle assessments, representing the finer skin structure (Ra). Ra was the average deviation of the profile from the mean line (arithmetic mean of the absolute values of the point's heights).|At Baseline and Day 15|Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available.|||µm||Standard Deviation|Mean
2536079|NCT03180645|Primary|Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated Versus (vs.) Untreated Side at Day 29|Using fringe projection and optical triangulation techniques, the 3D (three dimensional) surface structure of a designated investigational skin site on each side of the face was captured as an in vivo measurement using dermaTOP. From the captured 3D structure, roughness parameters were calculated. Ra is usually used for wrinkle assessments, representing the finer skin structure (Ra). Ra was the average deviation of the profile from the mean line (arithmetic mean of the absolute values of the point's heights).|At Baseline and Day 29|Analysis population was ITT (N=70) population included all participants who were randomized into the study and had at least one post-baseline clinical assessment available.|||Micro meter (µm)||Standard Deviation|Mean
2536080|NCT03180619|Secondary|Change From Baseline in MELD Score in Hepatically Impaired Participants at Week 96||Baseline, Week 96|||||||
2536081|NCT03180619|Secondary|Change From Baseline in MELD Score in Hepatically Impaired Participants at Week 48||Baseline, Week 48|||||||
2536082|NCT03180619|Secondary|Change From Baseline in Model for End-Stage Liver Disease (MELD) Score in Hepatically Impaired Participants at Week 24|MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity.|Baseline, Week 24|Participants in the Full Analysis Set only from Part B (Hepatic Impairment) were analyzed.|||units on a scale||Standard Deviation|Mean
2536083|NCT03180619|Secondary|Change From Baseline in CPT Score in Hepatically Impaired Participants at Week 96||Baseline, Week 96|||||||
2536084|NCT03180619|Secondary|Change From Baseline in CPT Score in Hepatically Impaired Participants at Week 48||Baseline, Week 48|||||||
2536085|NCT03180619|Secondary|Change From Baseline in Child-Pugh-Turcotte (CPT) Score in Hepatically Impaired Participants at Week 24|CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15, with higher scores indicating a greater severity of disease.|Baseline, Week 24|Participants in the Full Analysis Set only from Part B (Hepatic Impairment) were analyzed.|||units on a scale||Standard Deviation|Mean
2536086|NCT03180619|Secondary|Change From Baseline in FibroTest® Score at Week 96||Week 96|||||||
2536087|NCT03180619|Secondary|Change From Baseline in FibroTest® Score at Week 48||Baseline, Week 48|||||||
2536088|NCT03180619|Secondary|Change From Baseline in FibroTest® Score at Week 24|The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 24 minus the value at Baseline.|Baseline, Week 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2536089|NCT03180619|Secondary|Percentage of Participants With Normalized ALT at Week 96 by Central Laboratory and the AASLD Criteria||Week 96|||||||
2536090|NCT03180619|Secondary|Percentage of Participants With Normalized ALT at Week 48 by Central Laboratory and the AASLD Criteria||Week 48|||||||
2536091|NCT03180619|Secondary|Percentage of Participants With Normalized ALT at Week 24 by Central Laboratory and the AASLD Criteria|ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.|Week 24|Participants in the Full Analysis Set with Baseline ALT > ULN were analyzed.|||percentage of participants|||Number
2536092|NCT03180619|Secondary|Percentage of Participants With Normal ALT at Week 96 by Central Laboratory and the AASLD Criteria||Week 96|||||||
2536093|NCT03180619|Secondary|Percentage of Participants With Normal ALT at Week 48 by Central Laboratory and the AASLD Criteria||Week 48|||||||
2536094|NCT03180619|Secondary|Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 24 by Central Laboratory and the American Association for the Study of Liver Diseases (AASLD) Criteria|Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.|Week 24|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2536095|NCT03180619|Secondary|Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 96||Week 96|||||||
2536096|NCT03180619|Secondary|Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 48||Week 48|||||||
2536097|NCT03180619|Secondary|Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 24|HBeAg seroconversion was defined as HBeAg loss and HBeAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.|Week 24|The Serologically Evaluable Full Analysis Set for HBeAg Loss/Seroconversion were analyzed.|||percentage of participants|||Number
2536098|NCT03180619|Secondary|Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 96||Week 96|||||||
2536099|NCT03180619|Secondary|Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 48||Week 48|||||||
2536100|NCT03180619|Secondary|Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 24|HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.|Week 24|The Serologically Evaluable Full Analysis Set for HBeAg Loss/Seroconversion included all participants who were enrolled and received at least 1 dose of study drug, and with HBeAg positive and HBeAb negative or missing at baseline.|||percentage of participants|||Number
2536101|NCT03180619|Secondary|Percentage of Participants With Serological Response: Seroconversion to Anti-HBs in HBeAg-Positive Participants at Week 96||Week 96|||||||
2536102|NCT03180619|Secondary|Percentage of Participants With Serological Response: Seroconversion to Anti-HBs in HBeAg-Positive Participants at Week 48||Week 48|||||||
2536106|NCT03180619|Secondary|Percentage of Participants With Serological Response: Loss of Hepatitis s-Antigen (HBsAg) in Hepatitis B e-Antigen (HBeAg)-Positive Participants at Week 24|HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.|Week 24|The Serologically Evaluable Full Analysis Set for HBsAg Loss/Seroconversion (all participants who were enrolled and received at least 1 dose of study drug, and with HBsAg positive and HBsAb negative or missing at baseline) with available data were analyzed..|||percentage of participants|||Number
2536107|NCT03180619|Secondary|Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 96||Weeks 96|||||||
2536108|NCT03180619|Secondary|Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 48||Weeks 48|||||||
2536109|NCT03180619|Secondary|Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 24|The percentage of participants with HBV DNA < 20 IU/mL and target not detected (< LLOD; i.e. 10 IU/mL) at Week 24 was determined by the M = F approach.|Week 24|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2536110|NCT03180619|Secondary|Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ LLOD) at Week 96||Week 96|||||||
2536111|NCT03180619|Secondary|Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ LLOD) at Week 48||Week 48|||||||
2536112|NCT03180619|Secondary|Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ Lower Limit of Detection [LLOD]) at Week 24|The percentage of participants with HBV DNA < 20 IU/mL and target detected (≥ LLOD; i.e. 10 IU/mL) at Week 24 was determined by the M = F approach.|Week 24|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2536113|NCT03180619|Secondary|Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 96||Weeks 96|||||||
2536114|NCT03180619|Secondary|Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 48||Weeks 48|||||||
2536115|NCT03180619|Secondary|Percent Change From Baseline in Spine BMD at Week 96||Baseline, Week 96|||||||
2536116|NCT03180619|Secondary|Percent Change From Baseline in Spine BMD at Week 48||Baseline, Week 48|||||||
2536117|NCT03180619|Secondary|Percent Change From Baseline in Spine BMD at Week 24|Percent change = Change from baseline at a postbaseline visit/baseline * 100%.|Baseline, Week 24|Participants in the Spine DXA Analysis Set (all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline spine BMD values) with available data were analyzed.|||percent change||Standard Deviation|Mean
2536118|NCT03180619|Secondary|Percent Change From Baseline in Hip BMD at Week 96||Baseline, Week 96|||||||
2536119|NCT03180619|Secondary|Percent Change From Baseline in Hip BMD at Week 48||Baseline, Week 48|||||||
2536120|NCT03180619|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 24|Percent change = Change from baseline at a postbaseline visit/baseline * 100%.|Baseline, Week 24|Participants in the Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set (all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline hip BMD values) with available data were analyzed.|||percent change||Standard Deviation|Mean
2536121|NCT03180619|Secondary|Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 96||Baseline, Week 96|||||||
2536122|NCT03180619|Secondary|Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 48||Baseline, Week 48|||||||
2536123|NCT03180619|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFRcg) in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 24|"GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFRcg = (140 - age in years) x (body weight in kg) x (0.85 if female) divided by 72 x serum creatinine in mg/dL.~Moderate renal impairment= 30 mL/min ≤ eGFRCG ≤ 59 mL/min Severe renal impairment= 15 mL/min ≤ eGFRCG < 30 mL/min Change from baseline was calculated as the value at Week 24 minus the value at Baseline."|Baseline, Week 24|Participants in the Safety Analysis Set with available data were analyzed.|||mL/min||Inter-Quartile Range|Median
2536124|NCT03180619|Secondary|Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 96||Week 96|||||||
2536125|NCT03180619|Secondary|Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 48||Week 48|||||||
2536126|NCT03180619|Secondary|Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 96||Week 96|||||||
2536127|NCT03180619|Secondary|Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 48||Week 48|||||||
2536128|NCT03180619|Primary|Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 24|"Graded treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline visit, up to and including the date of last dose of study drug + 3 days for participants who permanently discontinued study drug or the last available date in the database snapshot for participants who were on treatment at the time of the analysis.~The most severe graded abnormality from all tests was counted for each participant."|Week 24|Participants in the Safety Analysis Set were analyzed.|||percentage of participants|||Number
2536129|NCT03180619|Primary|Percentage of Participants Who Experienced Graded Treatment-Emergent Adverse Events (AEs) at Week 24|"Treatment-emergent AEs were defined as:~Any AEs with an onset date on or after the study drug start date and no later than the study drug stop date + 3 days after permanent discontinuation of study drug;~Any AEs with onset date on or after the study drug start date for those who have not permanently discontinued study drug;~Any AEs leading to premature discontinuation of study drug.~The most severe graded AE from all tests was counted for each participant."|Week 24|The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2536696|NCT03159299|Secondary|Baseline Systolic and Diastolic Blood Pressure|Systolic and diastolic BP will be measured according to practice standards. Two readings separated by 1 minute will be averaged|Baseline|||||||
2536131|NCT03180515|Secondary|Percent Time Freezing|Freezing of gait episodes during stepping in place were identified using a validated computerized algorithm. The percent time freezing was calculated by dividing the time spent freezing by the total time to complete the task then multiplying by 100 to get a percent. If no freezing was observed, then the percent time freezing reported was 0.0%. The percent time spent freezing was compared while the participant was doing the stepping in place task on continuous deep brain stimulation (cDBS) and while the participant was doing the stepping in place task on adaptive deep brain stimulation (aDBS).|30 minutes|Due to limitations in technology and resources we were only able to test a single participant during the stepping in place task while on continuous DBS and while on adaptive DBS.|||% time freezing||Standard Deviation|Mean
2536132|NCT03180515|Secondary|Aim 2: Percent Time Freezing|Freezing of gait episodes during stepping in place were identified using a validated computerized algorithm, and during forward walking by a blinded rater. The percent time freezing was calculated by dividing the time spent freezing by the total time to complete the task then multiplying by 100 to get a percent. If no freezing was observed, then the percent time freezing reported was 0.0%.|30 minutes|12 participants total: the 8 freezers are the same participants across stimulation conditions; the 4 non-freezers are the same participants across stimulation conditions.|||% time freezing||Standard Deviation|Mean
2536133|NCT03180515|Secondary|Aim 2: Stride Time|Kinematic Features associated with Freezing of Gait|30 minutes|12 participants total: the 8 freezers are the same participants across stimulation conditions; the 4 non-freezers are the same participants across stimulation conditions.|||seconds||Standard Deviation|Mean
2536134|NCT03180515|Secondary|Aim 2: Arrhythmicity|Arrhythmicity during both forward walking and stepping in place was calculated using periods of walking or stepping when the subject was not freezing. According to previous studies, arrhythmicity is defined as the mean stride time coefficient of variation of both legs, and a greater stride time CV implies less rhythmic gait or stepping. Higher arrhythmicity corresponds to more arrhythmic, or more impaired, gait.|30 minutes|12 participants total: the 8 freezers are the same participants across stimulation conditions; the 4 non-freezers are the same participants across stimulation conditions.|||arrythmicity (CV%)||Standard Deviation|Mean
2536135|NCT03180515|Secondary|Aim 2: Asymmetry|"Asymmetry during both forward walking and stepping in place was calculated using periods of walking or stepping when the subject was not freezing. According to previous studies, asymmetry is defined as: 100*(absolute value of the natural log of the shorter average swing time over the longer average swing time) or mathematically: 100*| ln (SSWT/LSWT) |~where SSWT = shorter mean swing time LSWT = longer mean swing time"|30 minutes|12 participants total: the 8 freezers are the same participants across stimulation conditions; the 4 non-freezers are the same participants across stimulation conditions. Subjects were classified Freezer/Non-Freezer by the clinical history of a subject’s symptoms and/or if the subject displayed freezing behavior pre-operatively or during the tasks.|||asymmetry (%)||Standard Deviation|Mean
2536136|NCT03180515|Secondary|Aim 1: Beta Sample Entropy|The predictability of the local field potentials (band-pass filtered between 15-30 Hz for beta) was analyzed using Sample Entropy (SampEn), a nonlinear measure suitable for physiological time series. SampEn may be a more consistent measure and more suitable to shorter time series data than approximate entropy, partially due to the elimination of counting self matches. SampEn is calculated as the negative logarithm of the estimated conditional probability that if consecutive subseries of length m are similar according to some preset tolerance r, the consecutive subseries of length m+1 will be similar too. Here the length of the vector pairs, m, denotes the embedding dimension.|30 minutes|Subjects were classified as a Freezer or Non-Freezer by the clinical history of a subject’s symptoms and/or if the subject displayed freezing behavior pre-operatively or during the tasks.|||arbitrary units||Standard Deviation|Mean
2536137|NCT03180515|Secondary|Aim 1: Alpha Sample Entropy|The predictability of the local field potentials (band-pass filtered between 8-12 Hz for alpha) was analyzed using Sample Entropy (SampEn), a nonlinear measure suitable for physiological time series. SampEn may be a more consistent measure and more suitable to shorter time series data than approximate entropy, partially due to the elimination of counting self matches. SampEn is calculated as the negative logarithm of the estimated conditional probability that if consecutive subseries of length m are similar according to some preset tolerance r, the consecutive subseries of length m+1 will be similar too. Here the length of the vector pairs, m, denotes the embedding dimension.|30 minutes|Subjects were classified as a Freezer or Non-Freezer by the clinical history of a subject’s symptoms and/or if the subject displayed freezing behavior pre-operatively or during the tasks.|||arbitrary units||Standard Deviation|Mean
2536138|NCT03180515|Secondary|Aim 1: Beta Power|Subthalamic nucleus (STN) local field potentials (LFP) recordings demonstrate oscillatory neuronal activity in both the alpha (8-12 Hz) and beta (13-30 Hz) bands in the resting state in PD. Spectrograms were generated using a short-time Fourier transform, with a 1 second Hanning window and a 0.5 second overlap, creating a frequency resolution of 1 Hz. Power spectral densities were calculated using the Welch method with the same window and overlap parameters. Power was summed in the beta and alpha bands. This power can be representative of the magnitude of oscillatory activity in this frequency band occurring in this brain region.|30 minutes|Subjects were classified as a Freezer or Non-Freezer by the clinical history of a subject’s symptoms and/or if the subject displayed freezing behavior pre-operatively or during the tasks.|||arbitrary units (power)||Standard Deviation|Mean
2536139|NCT03180515|Secondary|Aim 1: Alpha Power|Subthalamic nucleus (STN) local field potentials (LFP) recordings demonstrate oscillatory neuronal activity in both the alpha (8-12 Hz) and beta (13-30 Hz) bands in the resting state in PD. Spectrograms were generated using a short-time Fourier transform, with a 1 second Hanning window and a 0.5 second overlap, creating a frequency resolution of 1 Hz. Power spectral densities were calculated using the Welch method with the same window and overlap parameters. Power was summed in the beta and alpha bands. This power can be representative of the magnitude of oscillatory activity in this frequency band occurring in this brain region.|30 minutes|Subjects were classified as a Freezer or Non-Freezer by the clinical history of a subject’s symptoms and/or if the subject displayed freezing behavior pre-operatively or during the tasks.|||arbitrary units (power)||Standard Deviation|Mean
2536140|NCT03180515|Primary|Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Related to aDBS|Safety, tolerability and feasibility of aDBS|30 min - 2 hours|Due to limitations in technology and resources we were only able to test a single participant during the stepping in place task while on continuous DBS and while on adaptive DBS.|||Number of Treatment Emergent AEs|||Number
2536150|NCT03180489|Primary|Change From Baseline in Perception of Hunger at Week 12|Participants answered a hunger questionnaire before liquid meal primer, immediately post liquid meal primer, 60 minutes post liquid primer, immediately post breakfast buffet, 60 minutes, 120 minutes and 180 minutes post breakfast buffet. Responses to how hungry do you feel right now? for 60 minutes post liquid meal primer ingestion are reported below. This was determined by using a visual analog scale. The left side of the analog scale represents a null answer (e.g. How hungry do you feel right now? Answer 0: Not hungry at all. The right side of the line represented the strongest answer in the opposite direction (e.g. How full to you feel right now)? Answer 100: Extremely hungry. The length of the line is 100 mm, thus the scale ranges for all answers were 0-100. All values are reported as values between 0 and 100. If the answers to the fullness questions increased, this represented an increased desire to eat.|Baseline, 12 weeks||||score on a scale||Standard Deviation|Mean
2536151|NCT03180489|Primary|Change From Baseline in Perception of Satiety at Week 12|Participants answered a satiety questionnaire before liquid meal primer, immediately post liquid meal primer, 60 minutes post liquid primer, immediately post breakfast buffet, 60 minutes, 120 minutes and 180 minutes post breakfast buffet. Responses how full do you feel right now? for 60 minutes post liquid meal primer ingestion are reported below. This was determined by using a visual analog scale. The left side of the analog scale represents a null answer (e.g. How full do you feel right now)? Answer 0: Not full at all. The right side of the line represented the strongest answer in the opposite direction (e.g. How full to you feel right now)? Answer 100: Extremely full. The length of the line is 100 mm, thus the scale ranges for all answers were 0-100. All values are reported as values between 0 and 100. If the answers to the fullness questions increased, this represented a decreased desire to eat.|Baseline, 12 weeks||||score on a scale||Standard Deviation|Mean
2536152|NCT03180489|Primary|Change From Baseline in Blood Pressure at Week 12|Blood pressure was measured with an automatic machine at baseline. Numbers are reported as systolic/diastolic|Baseline, 12 weeks||||mmHg||Standard Deviation|Mean
2536153|NCT03180489|Primary|Change From Baseline in Insulin Sensitivity at Week 12 Via Oral Glucose Tolerance Test|Insulin sensitivity was estimated by measuring circulating insulin concentrations after a 12 hour fast and after ingesting 75 g of glucose. Insulin was measured 0, 30, 60, 90 and 120 minutes after glucose ingestion. Time point 0 minutes is reported below.|Baseline, 12 weeks||||mU/L||Standard Deviation|Mean
2536154|NCT03180385|Primary|Average Post-operative PCA Fentanyl Dose||Up to 14 days post-operatively|All patients who were randomized ended up in the BiPAP group and not the NAVA group.|||boluses||Standard Deviation|Mean
2536155|NCT03180385|Primary|Average Post-operative Total Fentanyl Dose||Up to 14 days post-operatively|All patients who were randomized ended up in the BiPAP group and not the NAVA group.|||mcg/kg||Standard Deviation|Mean
2536156|NCT03180385|Primary|Average Post-operative Dexmedetomidine Dose||Up to 14 days post-operatively|All patients who were randomized ended up in the BiPAP group and not the NAVA group.|||mcg/kg||Standard Deviation|Mean
2536157|NCT03180385|Primary|Average Post-operative Lorazepam Dose||Up to 14 days post-operatively|All patients who were randomized ended up in the BiPAP group and not the NAVA group.|||mg/kg||Standard Deviation|Mean
2536158|NCT03180385|Primary|Average Post-operative Morphine Dose||Up to 14 days post-operatively|All patients who were randomized ended up in the BiPAP group and not the NAVA group.|||mg/kg||Standard Deviation|Mean
2536159|NCT03180385|Primary|Length of Non-Invasive Respiratory Support||Up to 14 days post-operatively|For this outcome, data for only one participant is available|||hours|||Number
2536160|NCT03180385|Primary|Length of Intubation||Up to 14 days post-operatively|All patients who were randomized ended up in the BiPAP group and not the NAVA group.|||hours||Standard Deviation|Mean
2536161|NCT03180385|Primary|Post-operative Sedation Scores-SBS|SBS (State Behavioral Scale)|Up to 14 days post-operatively|There were no SBS scores in the electronic medical record for either of these 2 participants so this is why results were not reported.||||||
2536162|NCT03180385|Primary|Post-operative Pain Scores-FLACC|FLACC (Face, Legs, Activity, Cry, Consolability) scale|Up to 14 days post-operatively|There were no FLACC scores in the electronic medical record for either of these 2 participants so this is why there are no results reported.||||||
2536163|NCT03180385|Primary|Average Post-operative Midazolam Dose||Up to 14 days post-operatively|All patients who were randomized ended up in the BiPAP group and not the NAVA group.|||mg/kg||Standard Deviation|Mean
2536164|NCT03180138|Secondary|Timeliness of Vaccinations|The percent of immunizations administered before or within 14 days after the scheduled date for the immunization. Calculated for each cohort.|12 months|The events analyzed here are the total number of vaccines rather than subjects in each cohort. The outcome measure is the percent of the number of vaccines that were administrated in a timely manner divided by the total number of scheduled vaccines.|||Percentage of vaccines|Vaccines||Number
2536165|NCT03180138|Primary|Immunization Rate|Percent of the total number of immunizations received divided by the total number of immunizations required at the time of measurement for each child. Calculated for each child and in each cohort.|12 months||||Percentage of immunizations||Inter-Quartile Range|Median
2536166|NCT03178942|Other Pre-specified|Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 2 Days.|"Parasitological cure is defined as failure to demonstrate microscopically the presence of scabies infestation (i.e., no living mites, no viable mite eggs, and no mite fecal matter present).~Clinical cure is defined as visual evidence of absence of new lesions and healing of original lesions, regardless the presence of post-scabietic nodules (i.e., post-scabietic nodules need not be considered as new lesions or persistence of old lesions)."|Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 2 Days|Patients who completed Visit 2 within 14 ± 2 days and Visit 3 within 28 ± 2 days|||Participants|||Count of Participants
2536183|NCT03177603|Secondary|Time of the Last Quantifiable Concentration (Tlast) of GSK2586881|Blood samples were collected at indicated time points for evaluation of tlast. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose (Day 1) and 0.08, 0.5, 1, 2, 4, 8 and 24 hours post-dose (Day 1)|Pharmacokinetic Population|||Hours||Full Range|Median
2536184|NCT03177603|Secondary|Last Observed Quantifiable Concentration (Ct) of GSK2586881|Blood samples were collected at indicated time points for evaluation of Ct. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose (Day 1) and 0.08, 0.5, 1, 2, 4, 8 and 24 hours post-dose (Day 1)|Pharmacokinetic Population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2536167|NCT03178942|Other Pre-specified|Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Between Day 26 and Day 32, Inclusive.|"Parasitological cure is defined as failure to demonstrate microscopically the presence of scabies infestation (i.e., no living mites, no viable mite eggs, and no mite fecal matter present).~Clinical cure is defined as visual evidence of absence of new lesions and healing of original lesions, regardless the presence of post-scabietic nodules (i.e., post-scabietic nodules need not be considered as new lesions or persistence of old lesions)."|Visit 2 within 14 ± 2 days and Visit 3 between Day 26 and Day 32, inclusive.|Number of patients with a Therapeutic Cure that completed Visit 2 within 14 ± 2 days and Visit 3 between Day 26 and Day 32, inclusive.|||Participants|||Count of Participants
2536168|NCT03178942|Other Pre-specified|Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 4 Days.|"Parasitological cure is defined as failure to demonstrate microscopically the presence of scabies infestation (i.e., no living mites, no viable mite eggs, and no mite fecal matter present).~Clinical cure is defined as visual evidence of absence of new lesions and healing of original lesions, regardless the presence of post-scabietic nodules (i.e., post-scabietic nodules need not be considered as new lesions or persistence of old lesions)."|Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 4 Days|Patients who completed Visit 2 within 14 ± 2 days and Visit 3 within 28 ± 4 days|||Participants|||Count of Participants
2536169|NCT03178942|Primary|Number of Patients in Each Treatment Group With Therapeutic Cure (Parasitological Cure Plus Clinical Cure) of Scabies|"Parasitological cure is defined as failure to demonstrate microscopically the presence of scabies infestation (i.e., no living mites, no viable mite eggs, and no mite fecal matter present).~Clinical cure is defined as visual evidence of absence of new lesions and healing of original lesions, regardless the presence of post-scabietic nodules (i.e., post-scabietic nodules need not be considered as new lesions or persistence of old lesions)."|Day 28 ± 4|The Per Protocol (PP) population was used for the analysis.|||Participants|||Count of Participants
2536170|NCT03178344|Secondary|Electroencephalogram (EEG)|The investigators will compare alpha oscillation power from resting-state EEG recordings before and after stimulation/sham at each session.|Before and after 40-minute stimulation at each session.||||percent change of uV^2/Hz||Standard Deviation|Mean
2536171|NCT03178344|Secondary|Percent Change in Respiration|Respiration rate, measured via a belt placed around the participant's abdomen as breaths per second.|Before and after 40-minute stimulation at each session.||||Percent change in breaths per second||Standard Deviation|Mean
2536172|NCT03178344|Secondary|Heart Rate Variability|Change in the ratio between the power in low frequency band and the power in high frequency band. As this outcome variable is a ratio between two items that are measured in microvolt^2, the ratio does not have a unit of measure.|Before and after 40-minute stimulation at each session.||||log-normalized percent change||Standard Deviation|Mean
2536173|NCT03178344|Primary|Salivary Cortisol|Change before and after stimulation|Before and after 40 minutes of stimulation||||log-normalized percent change µg/dL||Standard Deviation|Mean
2536174|NCT03178344|Primary|Salivary Alpha Amylase|Change after stimulation|Before and after 40-minute stimulation at each session.||||log-normalized percent change of U/mL||Standard Deviation|Mean
2536175|NCT03178266|Secondary|Patient Satisfaction|Subject Experience and Satisfaction results at 6 weeks post procedure. Subjects are asked of satisfaction with scar appearance on a scale of 1-minimal scar to 5-significant scar|6 weeks post knee arthroplasty||||score on a scale||Standard Deviation|Mean
2536176|NCT03178266|Primary|Patient and Observer Scar Assessment Scale (POSAS)|The subject and investigator will rate commonly described scar characteristics from a patient and observers perspective Subject and Physician will rate overall opinion of scar to normal skin where 1-Normal to 10-Very Different|6 weeks post knee arthroplasty||||score on a scale||Standard Deviation|Mean
2536177|NCT03177798|Secondary|Systolic Blood Pressure|Blood pressure will be monitored every 15 minutes, before, during, and after hemodialysis.|30 minutes before hemodialysis, during dialysis, and up to 1 hour after hemodialysis||||mmHg||Standard Deviation|Mean
2536178|NCT03177798|Primary|Phosphocreatine (PCR) Recovery Time After Knee Extension Assessed by 31 Phosphorus Magnetic Resonance Spectroscopy (31P-MRS)|Mitochondria function will be evaluated using 31P-MRS, which evaluates the concentration of phospho-creatine (PCr) and other phosphate-energy carrier molecules. After basal measurements, subjects will be asked to perform 90 seconds of knee extension followed by 4 minutes of rest. The exercise/rest cycle will be repeated 3 times. Magnetic resonance spectra will be used to calculate concentrations of inorganic phosphate (Pi), PCr, and adenosine triphosphate (ATP). The time constant tau of PCr recovery (time to achieve 66.3% maximal concentration during recovery) will be used to determine mitochondrial function.|Up to 2 hours after completion of drug infusion||||seconds||Standard Deviation|Mean
2536179|NCT03177603|Other Pre-specified|Change From Baseline in Cardiac Index (CI)|Cardiac index (CI) was measured using thermodilution. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was measured as ratio of post-dose visit value to Baseline value.|Baseline (Day 1, Pre-dose); 1 hour, 2 hours and 4 hours post-dose (Day 1)|Evaluable Population. Only those participants with data available at the specified time points were analyzed.|||Ratio||95% Confidence Interval|Geometric Mean
2536180|NCT03177603|Secondary|Apparent Terminal Phase Half-life (t1/2) of GSK2586881|Blood samples were collected at indicated time points for evaluation of t1/2. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose (Day 1) and 0.08, 0.5, 1, 2, 4, 8 and 24 hours post-dose (Day 1)|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2536181|NCT03177603|Secondary|Apparent Volume of Distribution of GSK2586881|Blood samples were collected at indicated time points for evaluation of apparent volume of distribution. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose (Day 1) and 0.08, 0.5, 1, 2, 4, 8 and 24 hours post-dose (Day 1)|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2536233|NCT03177395|Secondary|K18 (U/L)|In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death.|Baseline (2 hours)||||U/L||Standard Deviation|Geometric Mean
2536185|NCT03177603|Secondary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK2586881|Blood samples were collected at indicated time points for evaluation of AUC(0-inf). Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose (Day 1) and 0.08, 0.5, 1, 2, 4, 8 and 24 hours post-dose (Day 1)|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Hours*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2536186|NCT03177603|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of GSK2586881|Blood samples were collected at indicated time points for evaluation of AUC(0-t). Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose (Day 1) and 0.08, 0.5, 1, 2, 4, 8 and 24 hours post-dose (Day 1)|Pharmacokinetic Population|||Hours*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2536187|NCT03177603|Secondary|Time to Cmax (Tmax) of GSK2586881|Blood samples were collected at indicated time points for evaluation of tmax. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose (Day 1) and 0.08, 0.5, 1, 2, 4, 8 and 24 hours post-dose (Day 1)|Pharmacokinetic Population|||Hours||Full Range|Median
2536188|NCT03177603|Secondary|Maximum Observed Plasma Concentration (Cmax) of GSK2586881|Blood samples were collected at indicated time points for evaluation of Cmax. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose (Day 1) and 0.08, 0.5, 1, 2, 4, 8 and 24 hours post-dose (Day 1)|Pharmacokinetic population comprised of participants in the Safety Population for whom a pharmacokinetic sample was obtained and analyzed.|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2536189|NCT03177603|Secondary|Change From Baseline in Disease Biomarker: Cardiac Troponin-I|Blood samples were collected at specific time points to assess cardiac troponin I. Cardiac troponin I is a biomarker of cardiac stress. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was measured as ratio of post-dose visit value to Baseline value.|Baseline (Day 1, Pre-dose); 2 hours, 4 hours and 24 hours post-dose (Day 1)|Evaluable Population. Only those participants with data available at the specified time points were analyzed.|||Ratio||95% Confidence Interval|Geometric Mean
2536190|NCT03177603|Secondary|Change From Baseline in Nitrite, Nitrate and Endogenous Nitrite (Biomarkers of Nitric Oxide [NO])|Blood samples were collected at specific time points to evaluate levels of nitrite, nitrate and endogenous nitrite (En. nitrite) (biomarkers of NO). Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was measured as ratio of post-dose visit value to Baseline value.|Baseline (Day 1, Pre-dose); 2 hours, 4 hours and 24 hours post-dose (Day 1)|Evaluable Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Ratio||95% Confidence Interval|Geometric Mean
2536191|NCT03177603|Secondary|Change From Baseline in Disease Biomarkers: N-terminal Pro B-type Natriuretic Peptide (NT Pro-BNP)|Blood samples were collected at specific time points to evaluate NT pro-BNP, a biomarker of disease activity. NT-pro-BNP is a biomarker of cardiac stress or ventricular workload and decreases as a result of reduced force of contraction if pulmonary blood pressure is reduced. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was measured as ratio of post-dose visit value to Baseline value.|Baseline (Day 1, Pre-dose); 2 hours, 4 hours and 24 hours post-dose (Day 1)|Evaluable Population. Only those participants with data available at the specified time points were analyzed.|||Ratio||95% Confidence Interval|Geometric Mean
2536192|NCT03177603|Secondary|Pulmonary Wedge RAS Peptide: Angiotensin II/Angiotensin (1-7) Ratio at Indicated Time Points|Blood samples were collected to assess pulmonary wedge RAS peptides: Angiotensin II and Angiotensin (1-7). Data for angiotensin II/angiotensin (1-7) ratio is presented.|1 hour, 2 hours and 4 hours post-dose (Day 1)|Evaluable Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Ratio||95% Confidence Interval|Geometric Mean
2536193|NCT03177603|Secondary|Systemic RAS Peptide: Angiotensin II/Angiotensin (1-7) Ratio at Indicated Time Points|Blood samples were collected to assess systemic RAS peptides: Angiotensin II and Angiotensin (1-7). Data for angiotensin II/angiotensin (1-7) ratio is presented. Assessment of follow up visit was conducted between any day of Days 7 to 14.|0.08 hour, 0.5 hour, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post-dose (Day 1) and one sample between Day 7 to Day 14 (follow up visit)|Evaluable Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Ratio||95% Confidence Interval|Geometric Mean
2536194|NCT03177603|Secondary|Change From Baseline in Pulmonary Wedge RAS Peptides: Angiotensin II, Angiotensin (1-5) and Angiotensin (1-7)|Blood samples were collected to evaluate pulmonary wedge RAS peptides: Ang II, Ang (1-5) and Ang (1-7). Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was measured as ratio of post-dose visit value to Baseline value.|Baseline (Day 1, Pre-dose); 1 hour, 2 hours and 4 hours post-dose (Day 1)|Evaluable Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Ratio||95% Confidence Interval|Geometric Mean
2536195|NCT03177603|Secondary|Change From Baseline in Systemic Renin-Angiotensin System (RAS) Peptides: Angiotensin II, Angiotensin (1-5) and Angiotensin (1-7)|Blood samples were collected to evaluate systemic RAS peptides: Angiotensin (Ang) II, Ang (1-7) and Ang (1-5). Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was measured as ratio of post-dose visit value to Baseline value. Assessment of follow up visit was conducted between any day of Days 7 to 14.|Baseline (Day 1, Pre-dose); 0.08 hour, 0.5 hour, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post-dose (Day 1); and one sample between Day 7 to Day 14 (follow up visit)|Evaluable Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Ratio||95% Confidence Interval|Geometric Mean
2536234|NCT03177395|Secondary|Additional NAC Infusion|participants required additional NAC infusions after the 12-hour NAC regimen|Additional NAC at 12 hour||||Participants|||Count of Participants
2536196|NCT03177603|Secondary|Number of Participants With Positive Immunogenicity Results|Immunogenicity samples were collected into a serum-separating tube, mixed by gentle inversion 5 times and left to coagulate at room temperature for a minimum of 30 minutes and a maximum of 60 minutes. All samples were first tested for anti-angiotensin converting enzyme type 2 (ACE2) binding antibodies by screening and confirmation assay steps. If post-dose samples were found to be positive for anti-ACE2 binding antibodies, they would have been further characterized for anti-ACE2 neutralizing antibodies. Number of participants with positive immunogenicity results post-dosing are presented.|Up to Day 28|Safety Population|||Participants|||Count of Participants
2536197|NCT03177603|Secondary|Change From Baseline in Pulse Oximetry Parameter: Percent Oxygen in Blood|Percent oxygen in blood was measured using pulse oximetry after the participant had rested for at least 5 minutes. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Assessment of follow up visit was conducted between any day of Days 7 to 14.|Baseline (Day 1, Pre-dose); 0.5 hour, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post-dose (Day 1); and one sample between Day 7 to Day 14 (follow up visit)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Percentage of oxygen in blood||Standard Deviation|Mean
2536198|NCT03177603|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|12-lead ECGs were obtained at each time point using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and Corrected QT (QTc) intervals. Only those participants who had any abnormal ECG findings are presented. Abnormal ECG findings were categorized as clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Assessment of follow up visit was conducted between any day of Days 7 to 14.|4 hours and 24 hours post-dose (Day 1) and one sample between Day 7 to Day 14 (follow up visit)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2536199|NCT03177603|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|DBP and SBP were measured in supine position after at least a 5-minute rest. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Assessment of follow up visit was conducted between any day of Days 7 to 14.|Baseline (Day 1, Pre-dose); 0.5 hour, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post-dose (Day 1); and one sample between Day 7 to Day 14 (follow up visit)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Millimeters of mercury||Standard Deviation|Mean
2536200|NCT03177603|Secondary|Change From Baseline in Respiratory Rate|Respiratory rate was measured in supine position after at least a 5-minute rest. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Assessment of follow up visit was conducted between any day of Days 7 to 14.|Baseline (Day 1, Pre-dose); 0.5 hour, 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post-dose (Day 1); and one sample between Day 7 to Day 14 (follow up visit)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Breaths per minute||Standard Deviation|Mean
2536201|NCT03177603|Secondary|Change From Baseline in Pulse Rate|Pulse rate was measured in supine position after at least a 5-minute rest. Change from Baseline in pulse rate was evaluated. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Assessment of follow up visit was conducted between any day of Days 7 to 14.|Baseline (Day 1, Pre-dose); 0.5 hour, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours post-dose (Day 1); and one sample between Day 7 to Day 14 (follow up visit)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Beats per minute||Standard Deviation|Mean
2536202|NCT03177603|Secondary|Number of Participants With Urinalysis Results by Dipstick Method|Urine samples were collected to assess urine bilirubin, urine occult blood, urine glucose, urine ketones, and urine protein by dipstick test. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine bilirubin, urine occult blood, urine glucose, urine ketones and urine protein can be read as negative, trace, 1+, 2+ and 3+ indicating proportional concentrations in the urine sample.|24 hours post-dose (Day 1)|Safety Population|||Participants|||Count of Participants
2536203|NCT03177603|Secondary|Change From Baseline in Hematology Parameter: Reticulocytes|Blood samples were collected for the assessment of hematology parameter: reticulocytes. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Assessment of follow up visit was conducted between any day of Days 7 to 14.|Baseline (Day 1, Pre-dose), 24 hours post-dose (Day 1) and one sample between Day 7 to Day 14 (follow up visit)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Percentage of reticulocytes in blood||Standard Deviation|Mean
2536204|NCT03177603|Secondary|Change From Baseline in Hematology Parameter: Red Blood Cell (RBC) Count|Blood samples were collected for the assessment of hematology parameter: RBC count. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Assessment of follow up visit was conducted between any day of Days 7 to 14.|Baseline (Day 1, Pre-dose), 24 hours post-dose (Day 1) and one sample between Day 7 to Day 14 (follow up visit)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Trillion cells per liter||Standard Deviation|Mean
2536235|NCT03177395|Secondary|INR|international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)|value at 20 hours divided by baseline value for each patient||||ratio||Standard Deviation|Geometric Mean
2536205|NCT03177603|Secondary|Change From Baseline in Hematology Parameter: Mean Corpuscle Volume|Blood samples were collected for the assessment of hematology parameter, mean corpuscle volume. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Assessment of follow up visit was conducted between any day of Days 7 to 14.|Baseline (Day 1, Pre-dose), 24 hours post-dose (Day 1) and one sample between Day 7 to Day 14 (follow up visit)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Femtoliters||Standard Deviation|Mean
2536206|NCT03177603|Secondary|Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin|Blood samples were collected for the assessment of hematology parameter, mean corpuscle hemoglobin. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Assessment of follow up visit was conducted between any day of Days 7 to 14.|Baseline (Day 1, Pre-dose), 24 hours post-dose (Day 1) and one sample between Day 7 to Day 14 (follow up visit)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Picograms||Standard Deviation|Mean
2536207|NCT03177603|Secondary|Change From Baseline in Hematology Parameter: Hematocrit|Blood samples were collected for the assessment of hematology parameter, hematocrit. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Assessment of follow up visit was conducted between any day of Days 7 to 14.|Baseline (Day 1, Pre-dose), 24 hours post-dose (Day 1) and one sample between Day 7 to Day 14 (follow up visit)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Proportion of red blood cells in blood||Standard Deviation|Mean
2536208|NCT03177603|Secondary|Change From Baseline in Hematology Parameter: Hemoglobin|Blood samples were collected for the assessment of hematology parameter, hemoglobin. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Assessment of follow up visit was conducted between any day of Days 7 to 14.|Baseline (Day 1, Pre-dose), 24 hours post-dose (Day 1) and one sample between Day 7 to Day 14 (follow up visit)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2536209|NCT03177603|Secondary|Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count|Blood samples were collected for the assessment of hematology parameters: basophils, eosinophils, lymphocytes, monocytes, total neutrophils (T.neutrophils), platelet count and WBC count. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Assessment of follow up visit was conducted between any day of Days 7 to 14.|Baseline (Day 1, Pre-dose), 24 hours post-dose (Day 1) and one sample between Day 7 to Day 14 (follow up visit)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Giga cells per liter||Standard Deviation|Mean
2536210|NCT03177603|Secondary|Change From Baseline in Clinical Chemistry Parameter: Total Protein|Blood samples were collected for the assessment of clinical chemistry parameter, total protein. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Assessment of follow up visit was conducted between any day of Days 7 to 14.|Baseline (Day 1, Pre-dose), 24 hours post-dose (Day 1) and one sample between Day 7 to Day 14 (follow up visit)|Safety Population|||Grams per liter||Standard Deviation|Mean
2536211|NCT03177603|Secondary|Change From Baseline in Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen (BUN)|Blood samples were collected for the assessment of clinical chemistry parameters: calcium, glucose, potassium, sodium and BUN. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Assessment of follow up visit was conducted between any day of Days 7 to 14.|Baseline (Day 1, Pre-dose), 24 hours post-dose (Day 1) and one sample between Day 7 to Day 14 (follow up visit)|Safety Population|||Millimoles per liter||Standard Deviation|Mean
2536212|NCT03177603|Secondary|Change From Baseline in Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine|Blood samples were collected for the assessment of clinical chemistry parameters: direct bilirubin, total bilirubin and creatinine. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Assessment of follow up visit was conducted between any day of Days 7 to 14.|Baseline (Day 1, Pre-dose), 24 hours post-dose (Day 1) and one sample between Day 7 to Day 14 (follow up visit)|Safety Population|||Micromoles per liter||Standard Deviation|Mean
2536213|NCT03177603|Secondary|Change From Baseline in Clinical Chemistry Parameters: Alkaline Phosphatase, Alanine Amino Transferase and Aspartate Amino Transferase|Blood samples were collected for the assessment of clinical chemistry parameters: alkaline phosphatase, alanine amino transferase (ALT) and aspartate amino transferase (AST). Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Assessment of follow up visit was conducted between any day of Days 7 to 14.|Baseline (Day 1, Pre-dose), 24 hours post-dose (Day 1) and one sample between Day 7 to Day 14 (follow up visit)|Safety Population|||International units per liter||Standard Deviation|Mean
2536236|NCT03177395|Secondary|INR|international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)|20 hours||||ratio||Standard Deviation|Mean
2536237|NCT03177395|Secondary|INR|international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)|10 hours||||ratio||Standard Deviation|Mean
2536214|NCT03177603|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Any untoward event resulting in death, life threatening, requiring hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE.|Up to Day 28|Safety Population|||Participants|||Count of Participants
2536215|NCT03177603|Secondary|Number of Participants With Non-serious Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.|Up to Day 28|Safety Population comprised of all participants who took at least 1 dose of study treatment.|||Participants|||Count of Participants
2536216|NCT03177603|Primary|Change From Baseline in Mean Pulmonary Artery Pressure (mPAP)|The pulmonary artery pressure is a measure of the blood pressure found in the main pulmonary artery. Pulmonary arterial catheters were placed in participants and mPAP values were recorded from the right heart catheterization. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was measured as ratio of post-dose visit value to Baseline value.|Baseline (Day 1, Pre-dose); 1 hour, 2 hours and 4 hours post-dose (Day 1)|Evaluable Population. Only those participants with data available at the specified time points were analyzed.|||Ratio||95% Confidence Interval|Geometric Mean
2536217|NCT03177603|Primary|Change From Baseline in Cardiac Output (CO)|CO is the amount of blood pumped by the heart per minute. Pulmonary arterial catheters were placed in participants and CO values were recorded from the right heart catheterization. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was measured as ratio of post-dose visit value to Baseline value.|Baseline (Day 1, Pre-dose); 1 hour, 2 hours and 4 hours post-dose (Day 1)|Evaluable Population. Only those participants with data available at the specified time points were analyzed.|||Ratio||95% Confidence Interval|Geometric Mean
2536218|NCT03177603|Primary|Change From Baseline in Pulmonary Vascular Resistance (PVR)|PVR is the resistance generated by pulmonary circulation. Pulmonary arterial catheters were placed in participants and PVR values were recorded from the right heart catheterization. Baseline was defined as the latest pre-dose assessment (Day 1) with a non-missing value, including those from unscheduled visits. Change from Baseline was measured as ratio of post-dose visit value to Baseline value.|Baseline (Day 1, Pre-dose); 1 hour, 2 hours and 4 hours post-dose (Day 1)|Evaluable Population comprised of all participants who were in the safety population, who completed all Day 1 assessments (including up to 24 hours post dose) and were not deemed to have had major protocol deviations. Only those participants with data available at the specified time points were analyzed.|||Ratio||95% Confidence Interval|Geometric Mean
2536219|NCT03177395|Secondary|miR-122 (Copies/mcL)|MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose|Ratio - value at 20 hours divided by baseline value for each patient||||copies/mcL||Standard Deviation|Geometric Mean
2536220|NCT03177395|Secondary|miR-122 (Copies/mcL)|MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose|20 hours||||copies/mcL||Standard Deviation|Geometric Mean
2536221|NCT03177395|Secondary|miR-122(Copies/mcL)|MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose|10 hours||||copies/mcL||Standard Deviation|Geometric Mean
2536222|NCT03177395|Secondary|miR-122 (Copies/mcL)|MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose|Baseline (2 h)||||copies/mcL||Standard Deviation|Geometric Mean
2536223|NCT03177395|Secondary|miR-122 (Delta Count)|MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose|20 hours||||DCt||Standard Deviation|Mean
2536224|NCT03177395|Secondary|miR-122 (Delta Count)|MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose|10 hours||||DCt||Standard Deviation|Mean
2536225|NCT03177395|Secondary|miR-122 (Delta Count)|MiR-122 is a biomarker specific for liver injury and fully conserved (translational) across in vitro models, in vivo models and humans. MiR-122 is an early marker for acute liver injury which predicts a rise in ALT activity following paracetamol overdose|Baseline (2 hours)||||DCt||Standard Deviation|Mean
2536226|NCT03177395|Secondary|ccK18 (U/L)|Caspace-cleaved Keratin-18|Ratio - value at 20 hours divided by baseline value for each patient||||U/L||Standard Deviation|Geometric Mean
2536227|NCT03177395|Secondary|ccK18 (U/L)|The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death).|20 hours||||U/L||Standard Deviation|Geometric Mean
2536228|NCT03177395|Secondary|ccK18 (U/L)|The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death).|10 hours||||U/L||Standard Deviation|Geometric Mean
2536229|NCT03177395|Secondary|ccK18 (U/L)|The shorter, Caspase cleaved form of K-18 is released following hepatocyte apoptosis (programmed cell death).|Baseline (2 hours)||||U/L||Standard Deviation|Geometric Mean
2536230|NCT03177395|Secondary|K18 (U/L)|In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death.|Ratio - value at 20 hours divided by baseline value for each patient||||U/L||Standard Deviation|Geometric Mean
2536231|NCT03177395|Secondary|K18 (U/L)|In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death.|20 hours||||U/L||Standard Deviation|Geometric Mean
2536232|NCT03177395|Secondary|K18(U/L)|In paracetamol overdose, the full-length variant of Keratin-18 (K-18) is released by necrotic hepatocyte death.|10 hours||||U/L||Standard Deviation|Geometric Mean
2536238|NCT03177395|Secondary|INR|international normalised ratio (INR) characterise acute liver injury (ALI) and failure (ALF)|Baseline|All 24 participants received the full dose of PP100-01 according to the allocated dosing cohort, all participants received as a minimum 12 hours of NAC treatment (loading dose, plus further 10 hours). For both PP100-01 and NAC total dose was adjusted according to participant weight|||ratio||Standard Deviation|Mean
2536239|NCT03177395|Secondary|ALT(U/L)|The alanine aminotransferase (ALT) test is a blood test that checks for liver damage.|20 hours|All 24 participants received the full dose of PP100-01 according to the allocated dosing cohort, all participants received as a minimum 12 hours of NAC treatment (loading dose, plus further 10 hours). For both PP100-01 and NAC total dose was adjusted according to participant weight|||U/L||Standard Deviation|Geometric Mean
2536240|NCT03177395|Secondary|ALT(U/L)|The alanine aminotransferase (ALT) test is a blood test that checks for liver damage.|10 hours|All 24 participants received the full dose of PP100-01 according to the allocated dosing cohort, all participants received as a minimum 12 hours of NAC treatment (loading dose, plus further 10 hours). For both PP100-01 and NAC total dose was adjusted according to participant weight|||U/L||Standard Deviation|Geometric Mean
2536241|NCT03177395|Secondary|ALT(U/L)|The alanine aminotransferase (ALT) test is a blood test that checks for liver damage.|Baseline||||U/L||Standard Deviation|Geometric Mean
2536242|NCT03177395|Primary|Safety Events|Adverse Events and Serious Adverse Events|90 days|In addition to paracetamol overdose, 19 out of the 24 randomised participants reported taking overdoses of other medicines in addition to the paracetamol. All treatment groups included participants with paracetamol only overdoses and mixed overdoses|||participants|||Number
2536243|NCT03176654|Secondary|Plasma Concentration of Cortisol|Samples were analyzed for Human Cortisol, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).|Blood will be drawn immediately after HVLAT procedure.|Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT).|||ug/ml||Standard Deviation|Mean
2536244|NCT03176654|Secondary|Plasma Concentration of Cortisol|Samples were analyzed for Human Cortisol, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).|Within 10 minutes after consent signature completion|Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT).|||ug/ml||Standard Deviation|Mean
2536245|NCT03176654|Secondary|Plasma Concentration of Orexin A|Samples were analyzed for Human Orexin A, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).|Blood will be drawn immediately after HVLAT procedure.|Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT).|||ug/ml||Standard Deviation|Mean
2536246|NCT03176654|Secondary|Plasma Concentration of Orexin A|Samples were analyzed for Human Orexin A, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).|Within 10 minutes after consent signature completion|Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT).|||ug/ml||Standard Deviation|Mean
2536247|NCT03176654|Secondary|Plasma Concentration of Neurotensin|Samples were analyzed for Human Neurotensin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).|Blood will be drawn immediately after HVLAT procedure.|Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT).|||ug/ml||Standard Deviation|Mean
2536248|NCT03176654|Secondary|Plasma Concentration of Neurotensin|Samples were analyzed for Human Neurotensin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).|Within 10 minutes after consent signature completion|Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT).|||ug/ml||Standard Deviation|Mean
2536249|NCT03176654|Primary|Plasma Concentration of Oxytocin|Samples were analyzed for Human Oxytocin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).|Blood will be drawn immediately after HVLAT procedure.|Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT).|||ug/ml||Standard Deviation|Mean
2536250|NCT03176654|Primary|Plasma Concentration of Oxytocin|Samples were analyzed for Human Oxytocin, using the Multiplex Luminex-100 platform (Luminex, Inc., USA).|Blood will be drawn 10 minutes prior to HVLAT procedure.|Twenty-eight female subjects with non-specific mechanical neck pain randomly assigned to one of two interventions (HVLAT or Sham HVLAT).|||ug/ml||Standard Deviation|Mean
2536251|NCT03176407|Primary|Number of Patients Which do Not Accept the Medical Device, Measured in Numbers|Patients that have acceptance problems with the sensor capsule in respect to its size, form or other reasons.|at time of study inclusion, 1 day||||Participants|||Count of Participants
2536252|NCT03176407|Primary|Number of Participants With Sensor Capsule Ingestion Problems|In this outcome measure the feasibility of the capsule is evaluated and if patients have issues on swallowing the sensor capsule in respect to it's size, form or other reasons.|at time of capsule ingestion, 1 day||||Participants|||Count of Participants
2536253|NCT03176407|Primary|Number of Participants With Human Failures in Capsule Application|Human failures that appear during the capsule application or data readout.|until capsule excretion happened, an average of 10 days|One human failure occured.|||Participants|||Count of Participants
2536254|NCT03176407|Primary|Number of Participants With Device Deficiencies|All device deficiencies that appear in the study. In this outcome measure the safety and feasibility of the capsule is evaluated.|until data of the receiver is saved, an average of 2 weeks||||Participants|||Count of Participants
2536255|NCT03176407|Primary|Number of Participants With (Serious) Adverse Event Related to the Medical Device|"In this outcome measure the safety of the sensor capsule is evaluated in relation to the patient application.~Every malfunction, failure or characteristic change or performance of the medical device as well as each inappropriate labeling or instruction for use, which can directly or indirectly lead to death or a serious advers event that deteriorates the physical health state of a patient, user or another person.~Every technical or medical reason, which are a result of the causes mentioned in No.1 due to the characteristics or performance of the medical device."|until capsule excretion happened, an average of 10 days||||Participants|||Count of Participants
2536291|NCT03175120|Secondary|Change in Haematological Parameter- Erythrocytes|Change in erythrocytes from baseline (week 0) to week 26 is presented.|Week 0, week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||10^12 cells per liter (10^12/L)||Standard Deviation|Mean
2536256|NCT03176238|Secondary|Percent of Participants Event-free Probability Estimates of Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status|Time to deterioration of ECOG performance status, from baseline will be assessed using the ECOG Performance Status Scale (Oken, 1982). Time to deterioration is the time from date of start of treatment to the date of the event defined as deterioration. Deterioration is defined as an increase in performance status from 0 to 2 or greater, an increase in performance status from 1-2 to 3 or greater, or death due to any cause. Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Event-free probability estimates were are obtained from the Kaplan-Meier survival estimates.|Baseline up to approximately 50 weeks|Number of participants meeting criteria differed at visits|||percent of participants|||Number
2536257|NCT03176238|Secondary|Progression Free Survival (PFS)|"PFS is time from date of start of treatment to date of disease progression or death due to any cause, whichever occurs first.~b Percentiles with 95% CIs are calculated from PROC LIFETEST output using method of Brookmeyer and Crowley (1982)"|Baseline up to approximately 43 weeks for Asian countires and 40 weeks for Non-Asian countries|Full analysis set|||weeks||95% Confidence Interval|Median
2536258|NCT03176238|Secondary|Percentage of Participants Clinical Benefit Rate|Clinical benefit rate: Patients with best overall response rate of CR (any duration), PR (any duration) and SD with duration of 24 weeks or longer according to RECIST 1.1 criteria: Complete Response (CR)=disappearance of target lesions, Partial Response (PR) was >=30% decrease in sum of diameter of lesions, Progressive Disease (PD) was >=20% decrease in sum of diameter of lesions, Stable Disease (SD) does not qualify for PR, CR or PD, Unknown=not documented or assessed. Best overall response of CR = at least two determinations of CR at least 4 weeks apart before progression are required. Best overall response of PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required. The Overall response rate (ORR) is the percentage of patients with a best overall response of confirmed complete (CR) or partial (PR) response. The 95% confidence intervals (CI) were computed using the Clopper-Pearson method.|Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries|Full analysis set|||Percentage of participants||95% Confidence Interval|Number
2536259|NCT03176238|Secondary|Percentage of Participants Response Rates (Best Overall and Overall)|The best overall response for each patient is determined from the sequence of investigator overall lesion responses according to RECIST 1.1: Complete Response (CR)=disappearance of target lesions, Partial Response (PR) was >=30% decrease in sum of diameter of lesions, Progressive Disease (PD) was >=20% decrease in sum of diameter of lesions, Stable Disease (SD) does not qualify for PR, CR or PD, Unknown=not documented or assessed. To be assigned a best overall response of CR at least two determinations of CR at least 4 weeks apart before progression are required. To be assigned a best overall response of PR at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required. The Overall response rate (ORR) is the percentage of patients with a best overall response of confirmed complete (CR) or partial (PR) response. The 95% confidence intervals (CI) were computed using the Clopper-Pearson method|Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries|Full analysis set|||Percentage of participants||95% Confidence Interval|Number
2536260|NCT03176238|Primary|Summary of Number of Participants With Treatment Emergent Adverse Events (TEAE) - All Grades|Adverse events (AEs), serious adverse events (SAEs), changes from baseline in vital signs and laboratory results (hematology, blood chemistry, lipid profile) qualifying and reported as AEs. Although a patient might had two or more adverse events the patient is only counted once in a category. The same patient might appear in different categories. AESI: Adverse events of special interest.|Baseline up to approximately 43 weeks for Asian countires and 32 weeks for Non-Asian countries including a 30 day post treatment follow up period|Safety analysis set|||Participants|||Count of Participants
2536261|NCT03175562|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge Phase at 6 Week 48 (±2) Hours, Post Patch Removal|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Week 6 after 48 (±2) hours post patch removal|The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536262|NCT03175562|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge Phase at Week 6 After 24 (±2) Hours Post Patch Removal|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Week 6 after 24 (±2) hours post patch removal|The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536719|NCT03158012|Primary|Relative Abundance of Staphylococcus Aureus Compared to Baseline|Relative abundance of S. aureus 24 hours after initial treatment application (baseline).|24 Hours||||Relative abundance of S. aureus||Full Range|Mean
2536263|NCT03175562|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Challenge Phase at Week 6 After 30 Minutes (Maximum 1 Hour) Post Patch Removal|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Week 6 after 30 minutes (maximum 1 hour) post patch removal|The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536264|NCT03175562|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 19|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Day 19|The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536265|NCT03175562|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 17|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Day 17|The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536266|NCT03175562|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 15|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Day 15|The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536267|NCT03175562|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 12|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Day 12|The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Error|Mean
2536275|NCT03175172|Secondary|Disease Control Rate (DCR)|The percentage of evaluable subjects who exhibited a post-baseline tumor assessment BOR rating of CR, PR, or SD per modified RECIST for MPM.|BOR was assessed from the first dose of study treatment until documented disease progression, initiation of new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.|Analysis based on subjects who received ≥1 dose of study treatment and had ≥1 evaluable post-baseline modified RECIST for MPM tumor response assessment or were discontinued due to toxicity (the Evaluable Analysis Set [EAS]). 1 subject did not have post-baseline tumor response assessments and could not be evaluated for this outcome measure.|||Participants|||Count of Participants
2538411|NCT03100058|Secondary|Pharmacokinetics of LIK066: Observe Maximum Plasma Concentration (Cmax)|Observe maximum plasma concentration following administration of LIK066 (Cmax)|Summary at Week 24 from qd or bid regimens|Full Analysis Set|||ng/mL||Standard Deviation|Mean
2536268|NCT03175562|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 10|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Day 10|The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536269|NCT03175562|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 8|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Day 8|The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536270|NCT03175562|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 5|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Day 5|The ITT (N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536271|NCT03175562|Primary|Combined Skin Irritation (Dermal Response) and Superficial Irritation (Other Effects) Scores at Induction Phase at Day 3|A trained assessor assessed all patch sites. The following scores were used to express the response observed at the time of examination: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal papular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, 7=Strong reaction spreading beyond test site. Other features indicative irritation (Superficial irritation) scores were: Grade A/Score 0=Slight glazed appearance, Grade B/Score 1=Marked glazing, Grade C/Score 2=Glazing with peeling and cracking, Grade F/Score 3=Glazing with fissures, Grade G/Score 3=Film of dried serous exudate covering all or portion of the patch, Grade H/Score 3=Small petechial erosions and/or scabs. Superficial irritation scores were only provided if there was a dermal response score >0. Full range was 0-10. Lower score indicates better tolerability.|At Day 3|The Intent to treat (ITT, N=238) population included all participants who were randomized into the study and have skin irritation scores from at least one of the test sites available.|||Score on scale||Standard Deviation|Mean
2536272|NCT03175172|Secondary|Overall Survival (OS)|Number of weeks from the date of first dose of study treatment to the date of death from any cause, estimated using KM methods with 95% CIs for subjects in the SAF. Subjects without documentation of death at the time of analysis were censored as of the date the subject was last known to be alive, or the data cut-off date, whichever is earlier.|OS was assessed from the first dose of study treatment until death or study termination, whichever is earlier, assessed up to 25 weeks.|Analysis of OS was performed on subjects in the SAF.|||weeks||95% Confidence Interval|Median
2536273|NCT03175172|Secondary|Improvement in Pulmonary Function|Percentage of subjects with improvement in forced vital capacity (FVC), defined as an increase from baseline of either ≥400 mL or ≥20% assessed using spirometry|Subjects tested by spirometry at Screening and up to 7 days prior to dosing every other cycle starting at Cycle 3 until 4 weeks post final dose, assessed up to 16 weeks.|Analysis of FVC was performed on all subjects in the SAF. No subjects showed improvement in FVC.|||Participants|||Count of Participants
2536274|NCT03175172|Secondary|Progression-Free Survival (PFS)|Number of weeks from the date of first dose of study treatment to the first date of objectively determined progressive disease (PD) (per modified RECIST for MPM) or death from any cause, estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CI). Subjects who do not experience PD and are alive on or before the data cut-off date will be censored at the time of last tumor assessment or data cut-off date, whichever is earlier.|Subjects followed for disease progression from first dose of study treatment until documented disease progression, initiation of new cancer treatment, death, or study termination, whichever is earlier, assessed up to 9 weeks.|Analysis of PFS was performed on subjects in the SAF.|||weeks||95% Confidence Interval|Median
2536290|NCT03175120|Secondary|Change in Haematological Parameter- Basophils|Change in basophils from baseline (week 0) to week 26 is presented.|Week 0, week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||Percentage of basophils||Standard Deviation|Mean
2536276|NCT03175172|Primary|Overall Response Rate (ORR)|ORR was evaluated based upon the best overall response (BOR) for individual study subjects. BOR was determined by the highest post-baseline qualitative response value for each assessed subject as measured by modified response evaluation criteria in solid tumors (modified RECIST) for MPM (Byrne and Nowak, 2004) and given the following hierarchy of overall response results: complete response (CR) > partial response (PR) > stable disease (SD) > progressive disease (PD) > not evaluable (NE). The protocol-specified ORR was defined as the percentage of evaluable subjects with a BOR of CR or PR; however, this percentage was not calculated per the final study Statistical Analysis Plan (SAP). Therefore, the number of evaluable subjects with BOR RECIST v1.1 values of CR, PR, SD, PD, and NE are provided for this outcome measure.|BOR was assessed from the first dose of study treatment until documented disease progression, initiation of new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.|Analysis based on subjects who received ≥1 dose of study treatment and had ≥1 evaluable post-baseline modified RECIST for MPM tumor response assessment or were discontinued due to toxicity (the Evaluable Analysis Set [EAS]). 1 subject did not have post-baseline tumor response assessments and could not be evaluated for this outcome measure.|||Participants|||Count of Participants
2536277|NCT03175120|Secondary|Occurrence of Neutralising Liraglutide Antibodies Cross Reacting Native GLP-1|This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with neutralising liraglutide antibodies cross reacting native GLP-1 at week 27 are presented.|Week 27|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||Participants|||Count of Participants
2536278|NCT03175120|Secondary|Occurrence of Neutralising Liraglutide Antibodies|This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with neutralising liraglutide antibodies at week 27 are presented.|Week 27|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||Participants|||Count of Participants
2536279|NCT03175120|Secondary|Occurrence of Anti-liraglutide Antibodies Cross Reacting Native Glucagon-like Peptide-1 (GLP-1)|This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with anti-liraglutide antibodies cross reacting native GLP-1 at week 27 are presented.|Week 27|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||Participants|||Count of Participants
2536280|NCT03175120|Secondary|Occurrence of Anti-liraglutide Antibodies (Yes/no)|This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with anti-liraglutide antibodies at week 27 are presented.|Week 27|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||Participants|||Count of Participants
2536281|NCT03175120|Secondary|Total Insulin Antibodies|Serum samples were analysed for the presence of total insulin antibodies. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T).|Week 27|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||%B/T||Standard Deviation|Mean
2536282|NCT03175120|Secondary|Antibodies Cross-reacting to Human Insulin|Serum samples were analysed for the presence of antibodies cross-reacting to human insulin. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T).|Week 27|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||%B/T||Standard Deviation|Mean
2536283|NCT03175120|Secondary|Anti-insulin Degludec Specific Antibodies|Serum samples were analysed for the presence of anti-insulin degludec specific antibodies. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T).|Week 27|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||%B/T||Standard Deviation|Mean
2536284|NCT03175120|Secondary|Urinalysis (Erythrocytes, Protein, Glucose and Ketones)|The urinalysis was the measurements of protein, glucose, erythrocytes and ketones at week 0 and week 26 and categorised as negative, trace, 1+, 2+ and 3+. Number of participants in each category at week 0 and week 26 are presented.|Week 0, week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Number analyzed = participants with available data.|||Participants|||Count of Participants
2536285|NCT03175120|Secondary|Change in Calcitonin|Calcitonin levels were measured and were categorised as low, normal or high. Number of participants in each category at week 0 and week 26 were presented.|Week 0, week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Number analyzed = participants with available data.|||Participants|||Count of Participants
2536286|NCT03175120|Secondary|Change in Haematological Parameter- Neutrophils|Change in neutrophils from baseline (week 0) to week 26 is presented.|Week 0, week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||Percentage of neutrophils||Standard Deviation|Mean
2536287|NCT03175120|Secondary|Change in Haematological Parameter- Monocytes|Change in monocytes from baseline (week 0) to week 26 is presented.|Week 0, week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||Percentage of monocytes||Standard Deviation|Mean
2536288|NCT03175120|Secondary|Change in Haematological Parameter- Lymphocytes|Change in lymphocytes from baseline (week 0) to week 26 is presented.|Week 0, week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||Percentage of lymphocytes||Standard Deviation|Mean
2536289|NCT03175120|Secondary|Change in Haematological Parameter- Eosinophils|Change in eosinophils from baseline (week 0) to week 26 is presented.|Week 0, week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||Percentage of eosinophils||Standard Deviation|Mean
2536292|NCT03175120|Secondary|Change in Haematological Parameter- Leukocytes and Thrombocytes|Change in leukocytes and thrombocytes from baseline (week 0) to week 26 is presented.|Week 0, week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Number of participants analyzed = participants with available data.|||10^9 cells per liter (10^9/L)||Standard Deviation|Mean
2536293|NCT03175120|Secondary|Change in Haematological Parameter- Haemoglobin|Change in haemoglobin from baseline (week 0) to week 26 is presented.|Week 0, week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||mmol/L||Standard Deviation|Mean
2536294|NCT03175120|Secondary|Change in Haematological Parameter- Haematocrit|Change in haematocrit from baseline (week 0) to week 26 is presented.|Week 0, week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||Percentage of red blood cells||Standard Deviation|Mean
2536295|NCT03175120|Secondary|Change in Total Protein|Change in total protein from baseline (week 0) to week 26 is presented.|Week 0, week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||g/dL||Standard Deviation|Mean
2536296|NCT03175120|Secondary|Change in Creatinine|Change in creatinine from baseline (week 0) to week 26 is presented.|Week 0, week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||umol/L||Standard Deviation|Mean
2536297|NCT03175120|Secondary|Change in Total Bilirubin|Change in total bilirubin from baseline (week 0) to week 26 is presented.|Week 0, week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||Micromoles per liter (umol/L)||Standard Deviation|Mean
2536298|NCT03175120|Secondary|Change in Albumin|Change in albumin from baseline (week 0) to week 26 is presented.|Week 0, week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||Grams per deciliter (g/dL)||Standard Deviation|Mean
2536299|NCT03175120|Secondary|Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea|Change in calcium (total), albumin corrected calcium, potassium, sodium, urea from baseline (week 0) to week 26 is presented.|Week 0, week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Number analyzed = participants with available data.|||mmol/L||Standard Deviation|Mean
2536300|NCT03175120|Secondary|Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP)|Change in amylase, lipase, creatinine kinase, ALT, AST, ALP from baseline (week 0) to week 26 is presented.|Week 0, week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Number analyzed = participants with available data.|||Units per liter (U/L)||Standard Deviation|Mean
2536301|NCT03175120|Secondary|Change in Blood Pressure (Systolic and Diastolic Blood Pressure)|Change in blood pressure (systolic and diastolic blood pressure) from baseline (week 0) to week 26 is presented.|Week 0, week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analysed = participants with available data.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2536302|NCT03175120|Secondary|Change in Pulse|Change in pulse from baseline (week 0) to week 26 is presented.|Week 0, week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analyzed = participants with available data.|||Beats per minute (beats/min)||Standard Deviation|Mean
2536303|NCT03175120|Secondary|Change in Electrocardiogram (ECG)|The ECG was assessed by the investigator at baseline (week -2) and week 26 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 26 were presented.|Week -2, week 26|"SAS included all participants who received at least one dose of IDegLira or IDeg. Number analyzed=participants with available data."|||Participants|||Count of Participants
2536304|NCT03175120|Secondary|Eye Examination|Dilated fundoscopy or fundus photography was performed by the investigator at week -2 and week 26. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at week -2 and week 26 were presented.|Week -2, week 26|"SAS included all participants who received at least one dose of IDegLira or IDeg. Number analyzed=participants with available data."|||Participants|||Count of Participants
2536305|NCT03175120|Secondary|Change in Physical Examination|Physical examination parameters are categorised as cardiovascular system; central and peripheral nervous system; gastrointestinal system including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at week -2 and week 26 is presented.|Week -2, week 26|"SAS included all participants who received at least one dose of IDegLira or IDeg. Number analyzed=participants with available data."|||Participants|||Count of Participants
2536306|NCT03175120|Secondary|Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition|Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent hypoglycaemic episodes according to ADA definition is presented.|Weeks 0-27|SAS included all participants who received at least one dose of IDegLira or IDeg.|||Episodes|||Number
2536307|NCT03175120|Secondary|Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes|Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 a.m. both inclusive. Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes is presented.|Weeks 0-27|SAS included all participants who received at least one dose of IDegLira or IDeg.|||Episodes|||Number
2536308|NCT03175120|Secondary|Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes|Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes is presented.|Weeks 0-27|SAS included all participants who received at least one dose of IDegLira or IDeg.|||Episodes|||Number
2536309|NCT03175120|Secondary|Number of Treatment-emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes|Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 a.m. both inclusive. Number of treatment-emergent nocturnal severe or BG confirmed hypoglycaemic episodes is presented.|Weeks 0-27|SAS included all participants who received at least one dose of IDegLira or IDeg.|||Episodes|||Number
2536310|NCT03175120|Secondary|Number of Treatment-emergent Adverse Events (TEAEs)|A TEAE was defined as an adverse event with onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.|Weeks 0-27|SAS included all participants who received at least one dose of IDegLira or IDeg.|||Adverse events|||Number
2536311|NCT03175120|Secondary|Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes|Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Participants who achieved HbA1c ≤ 6.5% and change from baseline in body weight below or equal to zero and without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.|Week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Participants|||Count of Participants
2536312|NCT03175120|Secondary|Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes|Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Participants who achieved HbA1c < 7.0% and change from baseline in body weight below or equal to zero and without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.|Week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Participants|||Count of Participants
2536313|NCT03175120|Secondary|Participants Who Achieved HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes|Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Participants who achieved HbA1c ≤ 6.5% at week 26 without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.|Week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Participants|||Count of Participants
2536314|NCT03175120|Secondary|Participants Who Achieved HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes|Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Participants who achieved HbA1c < 7.0% at week 26 without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.|Week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Participants|||Count of Participants
2536315|NCT03175120|Secondary|Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero|Participants who achieved HbA1c ≤ 6.5% and change from baseline in body weight below or equal to zero is presented.|Week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Participants|||Count of Participants
2536720|NCT03157583|Secondary|Spectrum of Sun Protection|Broad spectrum of sun protection was calculated by the ratio of the arithmetic mean of SPF to the arithmetic mean of UVAPF. Higher values represents increased SPF protection.|Up to 30 minutes post UV exposure|Analysis population included all randomized participants who underwent irradiation at Visit 4.|||Ratio|||Number
2536316|NCT03175120|Secondary|Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero|Participants who achieved HbA1c < 7.0% and change from baseline in body weight below or equal to zero is presented.|Week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Participants|||Count of Participants
2536317|NCT03175120|Secondary|Participants Who Achieved HbA1c ≤ 6.5%, American Association of Clinical Endocrinologists (AACE) Target (Yes/no)|Participants who achieved HbA1c ≤ 6.5%, AACE target (yes/no) is presented.|Week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Participants|||Count of Participants
2536318|NCT03175120|Secondary|Participants Who Achieved HbA1c < 7.0%, ADA Target (Yes/no)|Participants who achieved HbA1c < 7.0%, ADA target (yes/no) is presented.|Week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Participants|||Count of Participants
2536319|NCT03175120|Secondary|Change in HOMA-B (Beta-cell Function)- Ratio to Baseline|Change in HOMA-B from baseline (week 0) to week 26 is presented as ratio to baseline.|Week 0, week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Ratio of beta-cell function||Geometric Coefficient of Variation|Geometric Mean
2536320|NCT03175120|Secondary|Change in Fasting Glucagon- Ratio to Baseline|Change in fasting glucagon (measured in picograms per milliliter (pg/mL)) from baseline (week 0) to week 26 is presented as ratio to baseline.|Week 0, week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Ratio of glucagon||Geometric Coefficient of Variation|Geometric Mean
2536321|NCT03175120|Secondary|Change in Fasting Insulin- Ratio to Baseline|Change in fasting insulin (measured in picomoles per liter (pmol/L)) from baseline (week 0) to week 26 is presented as ratio to baseline.|Week 0, week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Ratio of insulin||Geometric Coefficient of Variation|Geometric Mean
2536322|NCT03175120|Secondary|Change in Fasting C-peptide- Ratio to Baseline|Change in fasting C-peptide (measured in nanomoles per liter (nmol/L)) from baseline (week 0) to week 26 is presented as ratio to baseline.|Week 0, week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Ratio of C-peptide||Geometric Coefficient of Variation|Geometric Mean
2536323|NCT03175120|Secondary|Change in Fasting Free Fatty Acids- Ratio to Baseline|Change in fasting free fatty acids (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.|Week 0, week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Ratio of free fatty acids||Geometric Coefficient of Variation|Geometric Mean
2536324|NCT03175120|Secondary|Change in Fasting Triglycerides- Ratio to Baseline|Change in fasting triglycerides (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.|Week 0, week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Ratio of triglycerides||Geometric Coefficient of Variation|Geometric Mean
2536325|NCT03175120|Secondary|Change in Fasting Total Cholesterol- Ratio to Baseline|Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.|Week 0, week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Ratio of total cholesterol||Geometric Coefficient of Variation|Geometric Mean
2536326|NCT03175120|Secondary|Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline|Change in fasting VLDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.|Week 0, week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Ratio of VLDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2536327|NCT03175120|Secondary|Change in Fasting Low-density Lipoprotein (LDL) Cholesterol- Ratio to Baseline|Change in fasting LDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.|Week 0, week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Ratio of LDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2536328|NCT03175120|Secondary|Change in Fasting High-density Lipoprotein (HDL) Cholesterol- Ratio to Baseline|Change in fasting HDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.|Week 0, week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Ratio of HDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2536329|NCT03175120|Secondary|SMPG-9-point Profile (Individual Points in the Profile)|Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. SMPG-9-point profile (individual points in the profile) at week 26 is presented.|Week 26|FAS included all randomised participants. Number analysed = participants with available data.|||mmol/L||Standard Deviation|Mean
2536330|NCT03175120|Secondary|Insulin Dose|The mean of actual daily total insulin dose after 26 weeks of treatment is presented.|Week 26|SAS included all participants who received at least one dose of IDegLira or IDeg. Overall number of participants analysed = participants with available data.|||Units of insulin (U)||Standard Deviation|Mean
2536331|NCT03175120|Secondary|Change in SMPG-mean Post Prandial Increments|Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean postprandial increment over all meals from baseline (week 0) to week 26 is presented.|Week 0, week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||mmol/L||Standard Deviation|Mean
2536477|NCT03168841|Primary|Primary Endpoint - Efficacy|The primary efficacy end point is the proportion of subjects achieving complete cure at week 50. Complete cure is to be defined as a combination of 0% clinical involvement and mycological cure (mycological cure defined as negative KOH examination and negative fungal culture of the target toenail sample).|50 weeks||||Participants|||Count of Participants
2536332|NCT03175120|Secondary|Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile|Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. The mean of profile is defined as the area under the profile divided by measurement time and is calculated using the trapezoidal method. Change in mean of the 9-point SMPG profile from baseline (week 0) to week 26 is presented.|Week 0, week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||mmol/L||Standard Deviation|Mean
2536333|NCT03175120|Secondary|Change in Waist Circumference|Change in waist circumference from baseline (week 0) to week 26 is presented.|Week 0, week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Centimeter (cm)||Standard Deviation|Mean
2536334|NCT03175120|Secondary|Change in Fasting Plasma Glucose (FPG)|Change in FPG from baseline (week 0) to week 26 is presented.|Week 0, week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||mmol/L||Standard Deviation|Mean
2536335|NCT03175120|Secondary|Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes|Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 millimoles per liter (mmol/L) with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed hypoglycaemic episodes during 26 weeks of treatment is presented.|Up to 26 weeks|Safety analysis set (SAS) included all participants who received at least one dose of IDegLira or IDeg.|||Episodes|||Number
2536336|NCT03175120|Secondary|Change in Body Weight|Change in body weight from baseline (week 0) to week 26 is presented.|Week 0, week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Kilogram (kg)||Standard Deviation|Mean
2536337|NCT03175120|Primary|Change in HbA1c|Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 26 is presented.|Week 0, week 26|FAS included all randomised participants. Overall number of participants analysed = participants with available data.|||Percentage point of HbA1c||Standard Deviation|Mean
2536338|NCT03174366|Secondary|Change in Skin Temperature Difference in Degrees Celsius Between the Affected and Non-affected Limb at 6 Months.|Change in skin temperature difference in degrees Celsius between the affected and non-affected limb at 6 months.|6 months||||degrees Celsius||Standard Deviation|Mean
2536339|NCT03174366|Primary|Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]|Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]|1 year||||Participants|||Count of Participants
2536340|NCT03174158|Secondary|Change in Cigarettes Per Day|Self-reported number of cigarettes per day on days smoked, change|12 weeks post enrollment (end of treatment)||||change in cigarettes per day||Standard Deviation|Mean
2536341|NCT03174158|Secondary|Milligrams Nicotine Medication Used|Self-reported number of milligrams nicotine medication used|Total reported over 1 week post-enrollment||||milligrams during week 1||Standard Deviation|Mean
2536342|NCT03174158|Secondary|Days Nicotine Medication Used|Self-reported number of days nicotine lozenge and/or patch used|Total reported over 2 weeks post-enrollment||||days out of 2 weeks||Standard Deviation|Mean
2536343|NCT03174158|Secondary|Exhaled Carbon Monoxide|Exhaled carbon monoxide measured among self-reported quitters less than or equal to 9 parts per million|12 weeks post-enrollment (end of treatment)||||Participants|||Count of Participants
2536344|NCT03174158|Secondary|Percentage of Days Not Smoked|"Self-reported, In the past 30 days, how many days did you have at least one cigarette?"|12 weeks post-enrollment (end of treatment)||||percentage of past 30 days||Standard Deviation|Mean
2536345|NCT03174158|Secondary|Milligrams of Nicotine Medication Used|Self-reported milligrams of nicotine medication used|week 2 post enrollment||||milligrams during week 2||Standard Deviation|Mean
2536346|NCT03174158|Secondary|7 Day Point Prevalent Abstinence|"Self-reported abstinence Have you smoked, even a puff, in the past 7 days?"|12 weeks post-enrollment (end of treatment)||||Participants|||Count of Participants
2536347|NCT03174158|Secondary|7 Day Point Prevalent Abstinence|"Self-reported abstinence Have you smoked, even a puff, in the past 7 days?"|6 weeks post-enrollment||||Participants|||Count of Participants
2536348|NCT03174158|Primary|Quit Attempts|"Self-reported quit attempt in the last 12 weeks defined as intentional not smoking for 24 hours or more (During the past 12 weeks, have you quit smoking intentionally for 1 day or longer)."|End of treatment (12 week post-enrollment)||||Participants|||Count of Participants
2536349|NCT03174132|Secondary|Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS)|"Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane at 15, 30, 45 and 60 minutes after injection.~VAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) horizontal line labelled no pain at the left end and the worst pain you can imagine at the right end. The distance in mm from the left end (no pain) to the participant's VAS mark is measured with a standard ruler."|15, 30, 45, and 60 minutes after injection||||percentage of subjects||95% Confidence Interval|Number
2536350|NCT03174132|Primary|Treatment Differences in Pain (Restylane Perlane Side - Restylane Perlane Lidocaine Side) as Measured by a Visual Analogue Scale (VAS)|"Subjects that reported at least 10 mm less VAS pain associated with injections of Perlane-Lido compared to Perlane at the time of injection.~VAS=Visual Analogue Scale. The VAS is a subjective scale to measure pain intensity. The participant is instructed to put a vertical mark, approximating the pain experienced during the procedure, on a 100 mm (millimeter) horizontal line labelled no pain at the left end and the worst pain you can imagine at the right end. The distance in mm from the left end (no pain) to the participant's VAS mark is measured with a standard ruler."|At the time of injection||||percentage of subjects||95% Confidence Interval|Number
2536351|NCT03173170|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954||TAK-954 0.2 mg: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose; Itraconazole 200 mg and TAK-954 0.2mg: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose|The PK set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration. PK analysis set where Day 1 and 4 assessments were available.|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Geometric Mean
2536352|NCT03173170|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-954||TAK-954 0.2 mg: Day 1 pre-dose and at multiple time points (up to 120 hours) post-dose; Itraconazole 200 mg and TAK-954 0.2 mg: Day 4 pre-dose and at multiple time points (up to 120 hours) post-dose|The pharmacokinetic (PK) set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration.|||nanogram/milliliter (ng/mL)||Standard Deviation|Geometric Mean
2536353|NCT03172520|Primary|Change in Electromyography (EMG)|EMG is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.|baseline, approximately 3 hours|Study terminated due to limitations in timing and personnel. Data was not collected||||||
2536354|NCT03172481|Primary|Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP)-Combined Scores During the Full-Day Laboratory Classroom|The SKAMP rating scale is a validated tool that assesses behavioral symptoms of ADHD in a classroom setting. The SKAMP-C comprises 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13), and is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0 = none, 6 = maximal impairment), for a total possible combined score of 0 to 78 (lower score indicated fewer ADHD symptoms). During the Full-day Classroom visit, SKAMP-C was assessed at pre-dose and approximately 1, 2, 4, 6, 8, 10, 12, and 13 hours post-dose. Average post-dose score and change from pre-dose score were analyzed on the individual SKAMP-C scores.|Full-day Classroom - 13 hrs||||score on SKAMP-C||Standard Deviation|Mean
2536355|NCT03172364|Secondary|Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Eye|Participants asked Subject Self-Assessment questions at Baseline (Visit 2), prior to test product use, 1 hour (± 20 minutes) following first supervised product use, and following 21 (+2) days of product use. Participants scored each symptom asked in the question (Are you experiencing any redness, dryness, burning, itching or stinging of your eyes?) by using following score: 0= None, 1=Mild, 2= Moderate, and 3= Severe. Maximum observed value of this combined score was 3 and maximum possible combined score was 15. Minimum observed value of this combined score was 0 and minimum possible combined score was 0.|Baseline and after 21 (+2) days of test product use|ITT (N=113) comprised all randomized subjects who had at least 1 cutaneous or ocular assessment following study product application.|||Participants|||Count of Participants
2536356|NCT03172364|Secondary|Frequency of Participant Self-assessment Combined Score for Question Responses With Regards to Product Use Experience on Face|Participants asked Subject Self-Assessment questions at Baseline (Visit 2), prior to test product use, 1 hour (± 20 minutes) following first supervised product use, and following 21 (+2) days of product use. Participants scored each symptom asked in the question (Are you experiencing any redness, dryness, burning, itching or stinging of your face?) by using following score: 0= None, 1=Mild, 2= Moderate, and 3= Severe. Combined score face was obtained by summing the 5 subject assessments for face i.e. redness, dryness, burning, itching and stinging. Maximum observed value of this combined score was 3 and maximum possible combined score was 15. Minimum observed value of this combined score was 0 and minimum possible combined score was 0.|Baseline and after 21 (+2) days of test product use|ITT (N=113) comprised all randomized subjects who had at least 1 cutaneous or ocular assessment following study product application.|||Participants|||Count of Participants
2536357|NCT03172364|Primary|Combined Dermatologist and Ophthalmologist Score (Modified)|A modified combined dermatologist and ophthalmologist score was calculated, where the superficial irritation component was removed from the equation. Therefore, the modified combined dermatologist and ophthalmologist score was defined as the dermal response score + the combined ophthalmologist score (i.e., conjunctiva involvement score + lacrimal intensity score). No inferential statistic were performed for this endpoint.The full range was from 0 to 13 where lower scores indicated lower dermal irritation.|After 21 (+2) days of test product use|ITT (N=113) comprised all randomized subjects who had at least 1 cutaneous or ocular assessment following study product application.|||Participants|||Count of Participants
2536358|NCT03172364|Primary|Frequency of Combined Dermatologist and Ophthalmologist Score|The combined dermatologist and ophthalmologist score was calculated as the sum of the combined dermatologist score (i.e., dermal response score + superficial irritation score) and the combined ophthalmologist score (i.e., conjunctiva involvement score + lacrimal intensity score). No inferential statistic were performed for this endpoint.The full range was from 0 to 13 where lower scores indicated lower dermal irritation.|After 21 (+2) days of test product use|ITT (N=113) comprised all randomized subjects who had at least 1 cutaneous or ocular assessment following study product application.|||Participants|||Count of Participants
2536359|NCT03172364|Primary|Frequency of Combined Ophthalmologist Score|Ocular irritation assessed through the observation of the presence of two factors: Lacrimation Intensity and Conjunctiva Involvement. Conjunctiva involvement score are as follow: 0= None - No involvement, 1= Mild - Conjunctivae (palpebral and bulbar) injected above normal with possible chemosis (swelling); no discharge, 2= Moderate - Conjunctivae injected above normal; obvious swelling; possible discharge, and 3= Severe - Conjunctivae more diffuse, deeper crimson red, individual vessels not easily discernible; excessive swelling and/or discharge. Lacrimal intensity score are as follow: 0= None - No lacrimation observed, 1= Mild-Excessive wetness (no distinct tears), 2= Moderate - A few formed tears (contained in orbit), and 3= Severe - Intense tearing (leaving orbit). The combined ophthalmologist score was calculated in the following way: Combined ophthalmologist score = conjunctiva involvement score + lacrimal intensity score. Full range 0-6.|After 21 (+2) days of test product use|ITT (N=113) comprised all randomized subjects who had at least 1 cutaneous or ocular assessment following study product application. No inferential statistic were performed for this outcome.|||Participants|||Count of Participants
2536493|NCT03168308|Primary|Number of Hypoxic Episodes|Hypoxia was defined as an episode of peripheral oxygen saturation (SpO2) <94% on ≤2 L/min of oxygen by nasal cannula, or a SpO2 <98% on ≥2 L/min of oxygen, or postoperative SpO2 of ≥5% reduction compared to preoperative values.|Through patient's stay in the early postoperative period, approximately 1-2 hours.||||episode(s)||Inter-Quartile Range|Median
2536360|NCT03172364|Primary|Frequency of Combined Dermatologist Score|The intensity of any visual signs of irritation was recorded according to Dermal response score: 0=No evidence of irritation, 1=Minimal erythema; barely perceptible, 2=Definite erythema, readily visible; or minimal edema; or minimal popular response, 3=Erythema and papules, 4=Definite edema, 5=Erythema, edema, and papules, 6=Vesicular eruption, and 7=Strong reaction spreading beyond test site. Dermatologist also provided a superficial irritation score if the dermal response score >0. Superficial irritation score was as follow: grade A/score 0=Slight glazed appearance, grade B/score 1=Marked glazing, grade C/score 2=Glazing with peeling and cracking, grade F/score 3=Glazing with fissures, grade G/score 3=Film of dried serous exudate covering all or portion of the patch, and grade H/score 3=Small petechial erosions and/or scabs. The combined score was equal the sum of the dermal response score plus the numerical equivalent of the superficial irritation score. Full range 0-10.|After 21 (+2) days of test product use|Intent to Treat (ITT, N=113) comprised all randomized subjects who had at least 1 cutaneous or ocular assessment following study product application. No inferential statistic were performed for this outcome.|||Participants|||Count of Participants
2536361|NCT03171415|Secondary|Pharmacokinetics: Establishing Pharmacokinetic Profile of RZL-012.|Averaged Tmax values by cohort.|0.5, 1,2,3,4,5,6,8,12,16,24,30 hours||||Hour||Standard Deviation|Mean
2536362|NCT03171415|Secondary|Change From Baseline in Inflammatory Markers and Cytokines. Testing of Inflammatory Markers and Cytokines Will be Conducted by Blood Sampling.|"Changes from baseline in inflammatory markers and cytokines by visit, treatment, and cohort.~Testing of inflammatory markers and cytokines will be conducted by blood sampling."|28 days|The study was designed in a way that inflammation marker will be measured only for active and placebo subjects from cohorts 2-4|||mg/dL||Standard Deviation|Mean
2536363|NCT03171415|Secondary|Elucidation of the Histological Changes Account for the Thermogenic Effect.|"An abdominal subcutaneous adipose tissue biopsy will be taken from the injected side.~Histology results will be assessed for 2 subjects who were injected with 120 mg RZL-012 and for one subject who was injected with placebo."|56 days|Biopsy was done only for 2 active and 1 placebo subjects in cohort 3. Biopsy was not done in subjects from cohorts 1,2 or 4.|||Participants|||Count of Participants
2536364|NCT03171415|Secondary|Changes in Waist to Hip Ratio [WHR]|Changes from baseline in WHR by visit, treatment, and cohort. WHR is calculated by measurements of waist circumference and hip circumference.|56 days||||ratio||Standard Error|Mean
2536365|NCT03171415|Secondary|Changes in Body Weight|Changes from baseline in body weight by visit, treatment, and cohort.|56 days||||Kg||Standard Deviation|Mean
2536366|NCT03171415|Secondary|Pharmacokinetics: Establishing Pharmacokinetic Profile of RZL-012.|Averaged Cmax values by cohort.|1-2 days||||ng/mL||Standard Deviation|Mean
2536367|NCT03171415|Secondary|Changes in Blood Lipid Profile From Baseline.|Changes from baseline in lipid profile by visit, treatment, and cohort.|56 days||||mg/dL||Standard Deviation|Mean
2536368|NCT03171415|Secondary|Changes in Fasting Blood Glucose From Baseline.|Changes from baseline in fasting blood glucose by visit, treatment, and cohort.|56 days||||mg/dL||Standard Deviation|Mean
2536369|NCT03171415|Secondary|Local Reduction in Fat Mass as Measured by MRI. Local Reduction in Fat Will be Measured by Periodically MRI Scans of the Abdomen.|Subcutaneous Fat Mass (SFM) ratio (treated sites / control sites) averaged over the MRI slices by visit, treatment and cohort and the change from baseline in SFM ratio (in % from the ratio at baseline) compared between the treatment arms.|28-168 days|In cohort 4, one subjects was not analyzed due to MRI image quality (bubble)|||percentage of SFM reduction||Standard Deviation|Mean
2536370|NCT03171415|Secondary|Duration of the Thermogenic Effect From Day 28.|The duration of the thermogenic effect for subjects in the active arm with thermogenic effect (net-delta ≥ 1) by visit and cohort.|28-168 days||||days||Standard Deviation|Mean
2536371|NCT03171415|Primary|Efficacy: A Significant Thermogenesis at the Injected Site.|"Thermogenesis is measured by thermal imaging is non-invasive, non-radiating Infra-Red thermal camera that passively measures the emitting infra-red radiation of body surface.~Difference in temperatures between the sites (treated - not treated) by visit treatment along with the change from baseline (net-delta) in these differences by cohort and overall. Significant thermogenesis is defined as net-delta ≥ 1.~Outcome measure data table represents the number of subjects who demonstrated an increase that is higher than 1 celsius degree."|28-168 days||||Participants|||Count of Participants
2536372|NCT03171415|Primary|Safety: The Incidence of Treatment-related Adverse Events [AEs]|AEs will be assessed by significant clinical changes in safety parameter (e.g. vital signs, ECG, clinical laboratory evaluations)AEs incidence will be by body system, seriousness, severity and relation to study drug by cohort.|0-168 days|20-60 years old, overweight and obese by BMI definition (27.5 < BMI ≤ 34.9), adult males.|||participants|||Number
2536373|NCT03170609|Secondary|GBS6 Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination|Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.|1 month after vaccination|Evaluable immunogenicity population included all eligible participants who received GBS6 vaccine or placebo, had 1 month after vaccination blood drawn for assay and had at least 1 valid determinate assay result with no major protocol violation. ‘Number analyzed’ = number of participants with valid, determinate assay results for specified serotype.|||Microgram per milliliter||95% Confidence Interval|Geometric Mean
2536374|NCT03170609|Primary|Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 6 Months After Vaccination|An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility.|Within 6 months after vaccination|Safety population included all participants who received GBS6 vaccine or placebo.|||percentage of participants||95% Confidence Interval|Number
2536494|NCT03168295|Secondary|Change in Fasting Plasma Insulin|Change in Fasting Plasma Insulin in Type 2 Diabetes Mellitus subjects in diabetic subjects only|baseline and 240-300 minutes|Only type 2 diabetic subjects were included in this group, so the 8 subjects who were non-diabetic who had renal transplant were not included.|||U/ml||Standard Deviation|Mean
2536375|NCT03170609|Primary|Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Month After Vaccination|An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.|Within 6 months after vaccination|Safety population included all participants who received GBS6 vaccine or placebo.|||percentage of participants||95% Confidence Interval|Number
2536376|NCT03170609|Primary|Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. AEs included both non-serious AEs and SAEs.|Within 1 month after vaccination|Safety population included all participants who received GBS6 vaccine or placebo.|||percentage of participants||95% Confidence Interval|Number
2536377|NCT03170609|Primary|Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination|Fever:38.0-38.4 degree Celsius (C),38.5-38.9 degree C,39.0-40.0 degree C,>40.0 degree C;nausea/vomiting:mild(not interfered with activity/1-2times in 24 hours[hr]),moderate(some interference with activity/>2times in 24hr),severe(prevented daily activity;required intravenous hydration); diarrhea:mild(2-3 loose stools in 24hr),moderate(4-5 loose stools in 24hr),severe(>=6 loose stools in 24 hr); headache:mild(not interfered with activity),moderate(repeated use of non-narcotic pain reliever >24 hr/some interference with activity),severe(significant;any use of narcotic pain reliever/prevented daily activity);fatigue,muscle and joint pain:mild(not interfered with activity), moderate(some interference with activity),severe(significant;prevented daily activity).Prevented daily activity=missed days of work, school/otherwise incapacitating/use of narcotics for analgesia.Nausea/vomiting,diarrhea,headache,fatigue/tiredness,muscle and joint pain: grade 4=emergency room visit or hospitalization.|Within 14 days after vaccination|Safety population included all participants who received GBS6 vaccine or placebo.|||percentage of participants||95% Confidence Interval|Number
2536378|NCT03170609|Primary|Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination|Local reactions were collected by using an e-diary and included redness, swelling and pain at injection site. Redness and swelling were graded as: mild (2.5-5.0 centimeter [cm]), moderate (greater than [>] 5.0-10.0 cm) and severe (>10.0 cm), grade 4 for redness (necrosis or exfoliative dermatitis) and grade 4 for swelling (necrosis). Pain at injection site was graded as: mild (did not interfere with activity), moderate (repeated use of nonnarcotic pain reliever >24 hours or interfered with activity), severe (any use of narcotic pain reliever or prevented daily activity which resulted in missed days of work or school or was otherwise incapacitating, or included use of narcotics for analgesia), and grade 4 (required emergency room visit or hospitalization). The maximum severity (highest grading) of each location reaction within 14 days of vaccination was derived.|Within 14 days after vaccination|Safety population included all participants who received GBS6 vaccine or placebo.|||percentage of participants||95% Confidence Interval|Number
2536379|NCT03170609|Primary|Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade|Hemoglobin:Grade(G)1: 11-13.5g/dL, G2:9.5-12.4g/dL,G3:8-10.4 g/dL, G4:<8.0 g/dL; leukocyte increase:G1: 10.8-15*10^9/Liter[L],G2:>15-20*10^9/L, G3:>20-25*10^9/L, G4:>25*10^9/L,leukocyte decrease: G1: 2.5-3.5*10^9/L, G2: 1.5-<2.5*10^9/L, G3: 1-<1.5*10^9/L, G4:<1*10^9/L; neutrophil decrease:G1: 1.5-2*10^9/L, G2:1-<1.5*10^9/L, G3:0.5-<1*10^9/L,G4:<0.5*10^9/L; platelets:G1: 125-140*10^9/L, G2:100-124*10^9/L, G3:25-99*10^9/L, G4:<25*10^9/L; eosinophils: G1: 0.65-1.5*10^9/L, G2:>1.5-5*10^9/L, G3:>5*10^9/L, G4: hypereosinophilic;alanine aminotransferase,aspartate aminotransferase:G1: 1.1-2.5 *ULN, G2:2.6-5.0*ULN, G3:5.1-10*ULN, G4:>10*ULN; alkaline phosphatase:G1: 1.1-2*ULN, G2:2.1-3*ULN, G3:3.1-10*ULN, G4:>10*ULN; Bilirubin:G1: 1.1-1.5*ULN, G2: 1.26-2*ULN,G3: 1.51-3.0*ULN,G4:>1.75*ULN;blood urea nitrogen:G1:23-26mg/dL,G2:27-31mg/dL,G3:>31mg/dL, G4:dialysis;creatinine:G1:1.5-1.7mg/dL,G2:1.8-2mg/dL,G3:2.1-2.5 mg/dL,G4:dialysis.Categories with>=1 participant with abnormality are reported only.|1 week after vaccination|Analysis population for this outcome measure included a subset of participants who received GBS6 vaccine or placebo.|||percentage of participants|||Number
2536380|NCT03170544|Secondary|Time to Reach a 50% Decrease In Plasma Insulin Glargine Concentration (t1/2) Part 4|t1/2 is the time required for a given drug concentration in the plasma to decrease by 50% after the drug dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.|-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28) ]|The analysis population included participants in Part 4 who received glargine and complied with the protocol (exposure to treatment, availability of measurements, major protocol deviations) so that data exhibited effects of treatment. Five participants (Period 1:1; Period 2:2; Period 3:2) were excluded due to insufficient terminal phase data.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2536381|NCT03170544|Secondary|Time to Reach Maximum Plasma Insulin Glargine Concentration (Tmax) Part 4|Tmax is the amount of the time to reach the maximum concentration in the plasma after the drug dose is given in Part 4 only.|-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28) ]|The analysis population included participants in Part 4 who received glargine and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment, per the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.|||Hr||Full Range|Median
2536495|NCT03168295|Secondary|Change in Fasting Plasma Glucose|Change in Fasting Plasma Glucose in Type 2 Diabetes Mellitus subjects only|baseline and 240-300 minutes|Only type 2 diabetic subjects were included in this group, so the 8 non-diabetic renal transplant subjects were not included.|||mg/dL||Standard Deviation|Mean
2536382|NCT03170544|Secondary|Area Under the Plasma Drug Curve From 0 to Infinity (AUC0-inf) Insulin Glargine Part 4|AUC0-inf is a measure of the total concentration levels of drug in the plasma after the dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.|-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)|The analysis population included participants in Part 4 who received glargine and complied with the protocol (exposure to treatment, availability of measurements, major protocol deviations) so that data exhibited effects of treatment. Five participants (Period 1:1; Period 2:2; Period 3:2) were excluded due to insufficient terminal phase data.|||hr*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2536383|NCT03170544|Secondary|Maximal Plasma Insulin Glargine Concentration (Cmax) Part 4|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given in Parts 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.|-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)|The analysis population included participants in Part 4 who received glargine and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment, per the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2536384|NCT03170544|Secondary|Time to Reach a 50% Decrease In Plasma Insulin Glargine Concentration (t1/2) Parts 1 and 3|t1/2 is the time required for a given drug concentration in the plasma to decrease by 50% after the drug dose is given in Parts 1 and 3 only. Healthy participants received glargine in Panel A-E, and participants with T1DM received glargine in Panel G and H. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation. In Part 1, 8 participants (across 5 dosing panels) received glargine and had sufficient terminal phase data, and, in Part 3, 3 participants (across 2 dosing panels) received glargine and sufficient terminal phase data. These 8 participants in Part 1 were analyzed together and these 3 participants in Part 3 were analyzed together given the small numbers and same treatment (same dose of glargine) received.|-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)|The analysis population included participants in Parts 1 and 3 who received glargine and sufficiently complied with the protocol so that the data exhibited the effects of treatment. Two participants excluded in Part 1 and 1 participant excluded in Part 3 due to insufficient terminal phase data. Data across panels were pooled for Parts 1 and 3.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2536385|NCT03170544|Secondary|Time to Reach Maximum Plasma Insulin Glargine Concentration (Tmax) Parts 1 and 3|Tmax is the amount of the time to reach the maximum concentration in the plasma after the drug dose is given in Parts 1 and 3 only. Healthy participants received glargine in Panel A-E, and participants with T1DM received glargine in Panel G and H. In Part 1, 9 participants (across 5 dosing panels) received glargine and had quantifiable glargine levels, and, in Part 3, 4 participants (across 2 dosing panels) received glargine and had quantifiable glargine levels. These 9 participants in Part 1 were analyzed together and these 4 participants in Part 3 were analyzed together given the small numbers and same treatment (same dose of glargine) received.|-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)|The analysis population included participants in Parts 1 and 3 who received glargine and complied with the protocol so that data likely exhibited effects of treatment. One participant (Part 1) was excluded (no quantifiable glargine concentration). Data across panels were pooled for Parts 1 and 3.|||Hours||Full Range|Median
2536386|NCT03170544|Secondary|Area Under the Plasma Drug Curve From 0 to Infinity (AUC0-inf) Insulin Glargine Parts 1 and 3|AUC0-inf is a measure of the total concentration levels of drug in the plasma after the dose is given in Parts 1 and 3 only. Healthy participants received glargine in Panel A-E, and participants with T1DM received glargine in Panel G and H. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation. In Part 1, 8 participants (across 5 dosing panels) received glargine and had sufficient terminal phase data, and, in Part 3, 3 participants (across 2 dosing panels) received glargine and had sufficient terminal phase data. These 8 participants in Part 1 were analyzed together and these 3 participants in Part 3 were analyzed together given the small numbers and same treatment (same dose of glargine) received.|-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)|The analysis population included participants in Parts 1 and 3 who received glargine and complied with the protocol sufficiently so that the data exhibited the effects of treatment. Two participants in Part 1 and 1 in Part 3 were excluded due to insufficient terminal phase data. Data across panels were pooled for Parts 1 and 3.|||hr*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2536394|NCT03170544|Secondary|Time to Reach Maximum Plasma MK-1092 Concentration (Tmax) Parts 1 and 3|Tmax is the amount of the time to reach the maximum concentration in the plasma after the drug dose is given in Parts 1 and 3 only.|-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)|The analysis population included participants in Parts 1 and 3 who received MK-1092 and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment, per the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.|||Hours||Full Range|Median
2536575|NCT03163017|Secondary|Pain as Assessed by the PROMIS Score|Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures|6 months after 3D Fluoroscopy|Data was not collected for this outcome measure.||||||
2536387|NCT03170544|Secondary|Maximal Plasma Insulin Glargine Concentration (Cmax) Parts 1 and 3|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given in Parts 1 and 3 only. Healthy participants received glargine in Panel A-E, and participants with T1DM received glargine in Panel G and H. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation. In Part 1, 9 participants (across 5 dosing panels) received glargine and had quantifiable glargine levels, and, in Part 3, 4 participants (across 2 dosing panels) received glargine and had quantifiable glargine levels. These 9 participants in Part 1 were analyzed together and these 4 participants in Part 3 were analyzed together given the small numbers and same treatment (same dose of glargine) received.|-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)|The analysis population included participants in Parts 1 and 3 who received glargine and complied with the protocol sufficiently so that the data exhibited effects of treatment. One participant (Part 1) was excluded (no quantifiable glargine concentration). Data across panels were pooled for Parts 1 and 3.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2536388|NCT03170544|Secondary|Time to Reach a 50% Decrease In Plasma MK-1092 Concentration (t1/2) Part 4|t1/2 is the time required for a given drug concentration in the plasma to decrease by 50% after the drug dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.|-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)|The analysis population included participants in Part 4 who received MK-1092 and complied with the protocol (exposure to treatment, measurement availability, major protocol deviations) so that data exhibited effects of treatment. Seven participants (Period 1:1; Period 2:3; Period 3:3) were excluded due to insufficient terminal phase data.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2536389|NCT03170544|Secondary|Time to Reach Maximum Plasma MK-1092 Concentration (Tmax) Part 4|Tmax is the amount of the time to reach the maximum concentration in the plasma after the drug dose is given in Part 4 only.|-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)|The analysis population included participants in Part 4 who received MK-1092 and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment, per the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.|||Hours||Full Range|Median
2536390|NCT03170544|Secondary|Rate of Plasma Drug Removal (CL/F) MK-1092 Part 4|CL/F is the rate at which a drug is removed from the body via renal, hepatic, and other clearance pathways after the dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.|-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)|The analysis population included participants in Parts 4 who received MK-1092 and complied with the protocol (exposure to treatment, measurement availability, major protocol deviations) so that data exhibited effects of treatment. Seven participants (Period 1:1; Period 2:3; Period 3:3) were excluded due to insufficient terminal phase data.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2536391|NCT03170544|Secondary|Area Under the Plasma Drug Curve From 0 to Infinity (AUC0-inf) MK-1092 Part 4|AUC0-inf is a measure of the total concentration levels of drug in the plasma after the dose is given in Part 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.|-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)|The analysis population included participants in Part 4 who received MK-1092 and complied with the protocol (exposure to treatment, measurement availability, major protocol deviations) so that data exhibited effects of treatment. Seven participants (Period 1:1; Period 2:3; Period 3:3) were excluded due to insufficient terminal phase data.|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
2536392|NCT03170544|Secondary|Maximal Plasma MK-1092 Concentration (Cmax) Part 4|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given in Parts 4 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.|-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)|The analysis population included participants in Part 4 who received MK-1092 and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment, per the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.|||nM||Geometric Coefficient of Variation|Geometric Mean
2536393|NCT03170544|Secondary|Time to Reach a 50% Decrease In Plasma MK-1092 Concentration (t1/2) Parts 1 and 3|t1/2 is the time required for a given drug concentration in the plasma to decrease by 50% after the drug dose is given in Parts 1 and 3 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.|-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected and at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)|The analysis population included participants in Parts 1 and 3 who received MK-1092 and complied with the protocol (treatments, measurements, major protocol deviations) so that data exhibited effects of treatment. For the MK-1092 4.0 and 64 nmol/kg groups, 5 and 1 participants, respectively, were excluded (insufficient terminal phase data).|||Hours||Geometric Coefficient of Variation|Geometric Mean
2536576|NCT03163017|Secondary|Function as Assessed by the PROMIS Score|Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures|3 months after 3D Fluoroscopy|Data was not collected for this outcome measure.||||||
2536395|NCT03170544|Secondary|Rate of Plasma Drug Removal (CL/F) MK-1092 Parts 1 and 3|CL/F is the rate at which a drug is removed from the body via renal, hepatic, and other clearance pathways after the dose is given in Parts 1 and 3 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.|-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)|The analysis population included participants in Parts 1 & 3 who received MK-1092 and complied with the protocol (exposure to treatment, availability of measurements, absence of major protocol deviations) so that data exhibited effects of treatment. For the MK-1092 4.0 nmol/kg group, 5 participants were excluded (insufficient terminal phase data).|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2536396|NCT03170544|Secondary|Area Under the Plasma Drug Curve From 0 to Infinity (AUC0-inf) MK-1092 Parts 1 and 3|AUC0-inf is a measure of the total concentration levels of drug in the plasma after the dose is given in Parts 1 and 3 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.|-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)|The analysis population included participants in Parts 1 & 3 who received MK-1092 and complied with the protocol (exposure to treatment, availability of measurements, absence of major protocol deviations) so that data exhibited effects of treatment. For the MK-1092 4.0 nmol/kg group, 5 participants were excluded (insufficient terminal phase data).|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
2536397|NCT03170544|Secondary|Maximal Plasma MK-1092 Concentration (Cmax) Parts 1 and 3|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given in Parts 1 and 3 only. The method of dispersion referenced below of geometric coefficient of variation is actually percent geometric coefficient of variation.|-15 min (predose), 10 min, 30 min, 1.0 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 9.0 hr, 12 hr, 18 hr, 24 hr, an additional sample will be collected at the end of the clamp, 2d, 3d, 4d, 5d and 7d after SC dose and at post-trial (Day 14 and Day 28)|The analysis population included participants in Parts 1 and 3 who received MK-1092 and complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment, per the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.|||nM||Geometric Coefficient of Variation|Geometric Mean
2536398|NCT03170544|Secondary|Time-Weighted Average GIR (TWA[GIR]) After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Adult Participants With T2DM (Part 4)|The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (~every 5 minutes), allowing rapid changes to the rate of glucose infusion in Part 4 only. TWA(GIR)= Time-weighted average based on GIR values calculated as AUC (area under the curve) based on GIR values observed from time zero to t divided by t, t= 24 hours. Mean and 95% CI were based on a linear mixed effects model containing a fixed effect for treatment (MK, Glargine), period (Period 1, Period 2 and Period 3), a nested effect from participants within treatment, and interaction between treatment and period. MK-1092 or glargine was administered to a single cohort of participants in Periods 1, 2, and 3.|Up to approximately 24 hours post-dose|The analysis population included participants in Part 4 who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.|||mg/kg/min||95% Confidence Interval|Mean
2536399|NCT03170544|Secondary|Time-Weighted Average GIR (TWA[GIR]) After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Adult Participants With T1DM (Part 3)|The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (~every 5 minutes), allowing rapid changes to the rate of glucose infusion in Part 3 only. TWA(GIR)= Time-weighted average based on GIR values calculated as AUC (area under the curve) based on GIR values observed from time zero to t divided by t, t= 24 hours. Mean and 95% CI are based on a linear fixed effects model containing a fixed effect for treatment (MK-1092 Doses, Glargine). In Part 3, 4 participants (across 2 dosing panels) received glargine. These 4 participants were analyzed together given the small numbers and same treatment (same dose of glargine) received.|Up to approximately 24 hours post-dose|The analysis population included participants in Part 3 who complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment. Compliance included exposure to treatment, availability of measurements, absence of major protocol deviations. The glargine treatment group was pooled (n=2 participants per panel).|||mg/kg/min||95% Confidence Interval|Mean
2536400|NCT03170544|Secondary|Time-Weighted Average GIR (TWA[GIR]) After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Healthy Adult Participants (Part 1)|The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (~every 5 minutes), allowing rapid changes to the rate of glucose infusion in Part 1 only. TWA(GIR)= Time-weighted average based on GIR values calculated as AUC (area under the curve) based on GIR values observed from time zero to t divided by t, t= 24 hours. Mean and 95% CI are based on a linear fixed effects model containing a fixed effect for treatment (MK-1092 Doses, Glargine). In Part 1, 10 participants (across 5 dosing panels) received glargine. These 10 participants in Part 1 were analyzed together given the small numbers and same treatment (same dose of glargine) received.|Up to approximately 24 hours post-dose|The analysis population included participants in Part 1 who complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations. The glargine-treated group was pooled; n=2 participants per panel.|||mg/kg/min||95% Confidence Interval|Mean
2536401|NCT03170544|Secondary|GIRmax After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Adult Participants With Type 2 Diabetes Mellitus (T2DM) (Part 4)|The GIRmax, following administration of MK-1092 SC or glargine SC, was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (~every 5 minutes), allowing rapid changes to the rate of glucose infusion. For Part 4, a linear mixed effects model containing a fixed effect for treatment (MK-1092, Glargine), a nested effect from participants within treatment, an interaction between treatment and period (treatment by period: Period = Period 1, 2, 3) and a random effect due to participants was used. MK-1092 was administered to a single cohort of participants in Periods 1, 2, and 3. Glargine was administered to a single cohort of participants as 3.0 nmol/kg SC in Periods 1, 2, and 3.|Up to approximately 24 hours post-dose|The analysis population included participants in Part 4 who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations.|||mg/kg/min||95% Confidence Interval|Mean
2536402|NCT03170544|Primary|GIRmax After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Adult Participants With Type 1 Diabetes Mellitus (T1DM) (Part 3)|The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (~every 5 minutes), allowing rapid changes to the rate of glucose infusion. Mean and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK-1092 Doses, Glargine). In Part 3, 4 participants (across 2 dosing panels) received glargine. These 4 participants were analyzed together given the small numbers and the same treatment (same dose of glargine) received.|Up to approximately 24 hours post-dose|The analysis population included participants in Part 3 who complied with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations. The glargine-treated group was pooled; n=2 participants per panel.|||mg/kg/min||95% Confidence Interval|Mean
2536403|NCT03170544|Secondary|GIRmax After a Single Dose Administration of Subcutaneous MK-1092 or Glargine to Healthy Adult Participants (Part 1)|The GIRmax required to maintain blood glucose at each participants' individual clamp target, following administration of MK-1092 SC or glargine SC was determined by use of a continuous glucose infusion during the euglycemic clamp so that glucose levels remained in the euglycemic range and hypoglycemia was prevented. Blood glucose was monitored frequently (~every 5 minutes), allowing rapid changes to the rate of glucose infusion. Mean and 95% CI were based on a linear fixed effects model containing a fixed effect for treatment (MK-1092 doses, Glargine). In Part 1, 10 participants (across 5 dosing panels) received glargine. These 10 participants in Part 1 were analyzed together given the small numbers and same treatment (same dose of glargine) received.|Up to approximately 24 hours post-dose|The analysis population included participants in Part 1 who complied with the protocol sufficiently to ensure that these data likely exhibited the effects of treatment. Compliance included exposure to treatment, availability of measurements, and absence of major protocol deviations. The glargine-treated group was pooled; n=2 participants per panel.|||mg/kg/min||95% Confidence Interval|Mean
2536404|NCT03170544|Primary|Number of Participants Who Discontinued the Study Due to an AE|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.|Up to 58 days|The analysis population included all participants who received at least one dose of the investigational drug. Post-trial adverse events were pooled across treatment groups in each part of the study.|||Participants|||Count of Participants
2536405|NCT03170544|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Adverse events that occurred beyond 14 days of dosing were considered Post-Trial AEs. Given the half-life of MK-1092 and glargine, any events observed beyond 14 days would not be considered a result of study drug and were therefore presented together.|Up to 112 days|The analysis population included all participants who received at least one dose of the investigational drug. Post-trial adverse events were pooled across treatment groups in each part of the study.|||Participants|||Count of Participants
2536406|NCT03170232|Secondary|Change From Baseline in Mean Number of Puffs Per Day of Rescue Medication Using Diary Data in 4-week Intervals|Participants were instructed to complete the daily diary in the evening to collect the number of puffs of rescue medications over each 24-hour period. The maximum number of puffs of rescue medication use were counted for the day and were used to determine if it was a recue-free day. A rescue-free day was defined as a day where the total number of puffs were 0. The 4-weekly means were calculated and presented. Baseline was defined as the mean number of puffs of rescue medication per day from the latest (7 days before study treatment start date and date of Screening) to the day before study treatment start date. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1 pre-dose), Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24, Weeks 25-28, Weeks 29-32, Weeks 33-36, Weeks 37-40, Weeks 41-44 and Weeks 45-48|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Number of puffs per day||Standard Deviation|Mean
2536414|NCT03170232|Secondary|Time to First Healthcare Resource Utilization (HCRU) Chronic Obstructive Pulmonary Disease (COPD) Exacerbation|An exacerbation of COPD was defined by a worsening of symptoms requiring additional treatment or hospitalization. The date of onset of COPD exacerbations were planned to be recorded. This analysis was planned but data was not collected, as the study was terminated pre-maturely.|Up to Week 52|Safety Population. This analysis was planned but data was not collected, as the sample size was too small and study was terminated pre-maturely.||||||
2536407|NCT03170232|Secondary|Change From Baseline in Mean Percentage Rescue Free Days Using Diary Data in 4-week Intervals|Participants were instructed to complete the daily diary in the evening to collect the number of puffs of rescue medications over each 24-hour period. The maximum number of puffs of rescue medications use were counted for the day and were used to determine if it was a recue-free day. A rescue-free day was defined as a day where the total number of puffs were 0. The 4-weekly means were calculated and presented. Baseline was defined as the mean number of puffs of rescue medication per day from the latest (7 days before study treatment start date and date of Screening) to the day before study treatment start date. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1 pre-dose), Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24, Weeks 25-28, Weeks 29-32, Weeks 33-36, Weeks 37-40, Weeks 41-44 and Weeks 45-48|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Percentage of days||Standard Deviation|Mean
2536408|NCT03170232|Secondary|Change From Baseline in COPD Assessment Test (CAT) Score|The COPD Assessment Test (CAT) is a short and simple participant completed questionnaire which was developed for use in routine clinical practice to measure the health status of participants with COPD. The CAT is an 8-item questionnaire suitable for completion by all participants diagnosed with COPD. Participants rated their experience on a 6-point scale, ranging from 0 (maximum impairment) to 5 (no impairment). A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0-40. Higher scores indicated greater disease impact. Baseline was defined as the score recorded prior to dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1 pre-dose), Weeks 12, 24 and 32|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Scores on a scale||Standard Deviation|Mean
2536409|NCT03170232|Secondary|Change From Baseline in SGRQ Impacts Score|The SGRQ Questionnaire is a well-established, self‐completed tool, comprising of 50 questions with 76 weighted responses designed to measure Quality of Life in participants with diseases of airway obstruction. It consists of two parts; Part 1 produces the symptoms score and Part 2 produces the activity and impacts score. SGRQ impacts score was calculated by summing weights from all positive items in impacts score component, divided by sum of weights for all items in impacts score component and multiplying by 100. The SGRQ impacts score ranges from 0 to 100, with 0 implying the best possible health status and 100 implying worst possible health status. Baseline was defined as the score recorded prior to dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1 pre-dose), Weeks 12, 24 and 32|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Scores on a scale||Standard Deviation|Mean
2536410|NCT03170232|Secondary|Change From Baseline in SGRQ Activity Score|The SGRQ Questionnaire is a well-established, self‐completed tool, comprising of 50 questions with 76 weighted responses designed to measure quality of life in participants with diseases of airway obstruction. It consists of two parts; Part 1 produces the symptoms score and Part 2 produces the activity and impacts score. SGRQ activity score was calculated by summing weights from all positive items in activity score component, divided by sum of weights for all items in activity score component and multiplying by 100. The SGRQ activity score ranges from 0 to 100, with 0 implying the best possible health status and 100 implying worst possible health status. Baseline was defined as the score recorded prior to dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1 pre-dose), Weeks 12, 24 and 32|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Scores on a scale||Standard Deviation|Mean
2536411|NCT03170232|Secondary|Change From Baseline in SGRQ Symptoms Score|The SGRQ Questionnaire is a well-established, self‐completed tool, comprising of 50 questions with 76 weighted responses designed to measure Quality of Life in participants with diseases of airway obstruction. It consists of two parts; Part 1 produces the symptoms score and Part 2 produces the activity and impacts score. SGRQ symptoms score was calculated by summing weights from all positive items in symptoms score component, divided by sum of weights for all items in symptoms score component and multiplying by 100. The SGRQ symptoms score ranges from 0 to 100, with 0 implying the best possible health status and 100 implying worst possible health status. Baseline was defined as the score recorded prior to dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1 pre-dose), Weeks 12, 24 and 32|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Scores on a scale||Standard Deviation|Mean
2536412|NCT03170232|Secondary|Number of SGRQ Responders|Response was defined as a SGRQ total score of 4 units below Baseline or lower. The SGRQ Questionnaire is a well-established, self‐completed tool, with 50 questions comprising three domains; Symptoms, Activity, and Impacts scores (each ranging from 0 to 100). SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The SGRQ total score ranges from 0 to 100, with 0 implying the best possible health status and 100 implying worst possible health status. Number of SGRQ responders are presented.|Weeks 12, 24 and 32|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2536413|NCT03170232|Secondary|Change From Baseline in FEV1|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements were collected using a spirometer. Baseline was defined as the measurement performed prior to the first dose on Day 1. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1 pre-dose), Weeks 2, 4, 8, 12, 16, 20, 24, 32 and 40|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Liters||Standard Deviation|Mean
2536415|NCT03170232|Secondary|C-reactive Protein (CRP) Levels (Safety Biomarker) After Administration of Danirixin|Peripheral venous blood samples were planned to be collected and tested for biomarker that was indicative of inflammation (CRP). This analysis was planned but data was not collected, as the study was terminated pre-maturely.|Up to Week 52|Safety Population. This analysis was planned but data was not collected, as the sample size was too small and study was terminated pre-maturely.||||||
2536416|NCT03170232|Secondary|Number of Participants With Worst-case Vital Signs Results by PCI Criteria|Vital signs included systolic blood pressure (SBP) and diastolic blood pressure (DBP), heart rate and respiratory rate. Vital signs were measured in a semi-supine position after 5 minutes rest. PCI ranges were, SBP (millimeters of mercury): <90 (low) or >160 (high), DBP (millimeters of mercury): <40 (low) or >110 (high), heart rate (beats per minute): <35 (low) or >120 (high), respiration rate (breaths per minute): <8 (low) or >30 (high). Participants were counted in the worst-case category that their value changes to (low, within range or no change, or high), unless there was no change in their category. Participants whose value category were unchanged (high to high), or whose value became within range, were recorded in the 'to within range or no change' category.|Up to Week 52|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2536417|NCT03170232|Secondary|Change From Baseline in ECG Parameters: PR, QRS, QT and QTc Intervals|12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Baseline was defined as the value obtained at pre-dose on Day 1. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1 pre-dose), Weeks 4, 12 and 24|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Milliseconds||Standard Deviation|Mean
2536418|NCT03170232|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters: Heart Rate|12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. Baseline was defined as the value obtained at pre-dose on Day 1. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline (Day 1 pre-dose), Weeks 4, 12 and 24|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Beats per minute||Standard Deviation|Mean
2536419|NCT03170232|Secondary|Number of Participants With Abnormalities in Urinalysis Data|Urine samples were planned to be collected to analyze the following parameters: specific gravity, pH, glucose, protein, blood and ketones. This analysis was planned but data was not collected, as study was terminated pre-maturely.|Up to Week 52|Safety Population. This analysis was planned but data was not collected, as study was terminated pre-maturely.||||||
2536420|NCT03170232|Secondary|Number of Participants With Worst Case Liver Function Tests Results by PCI Criteria|Blood samples for liver function tests were collected at indicated time points. PCI ranges were, alanine aminotransferase (ALT) (units per liter[U/L]): >=3x upper limit of normal (ULN) (high), alkaline phosphatase (alk phosp) (U/L): >=2x ULN (high), aspartate amino transferase (AST) (U/L): >=3x ULN (high), direct bilirubin (µmol/L): >=2x ULN (high), total bilirubin (µmol/L): >=2x ULN (high). Participants were counted in the worst case if their laboratory value changes to low, or within range or no change, or high. Participants were counted in within range if their value was unchanged. Limits with 'x' are multipliers of central laboratory normal range.|Up to Week 52|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2536421|NCT03170232|Secondary|Number of Participants With Worst Case Clinical Chemistry Results by PCI Criteria|Blood samples for clinical chemistry parameters were collected at indicated time points. PCI ranges were, calcium (millimoles per liter [mmol/L]): 0.85x (low) or 1.08x (high), bicarbonate (mmol/L): <18 (low) or >32 (high), chloride (mmol/L): 0.90x (low) or 1.10x (high), creatinine (micromoles per liter[µmol/L]): 1.30x (high), glucose(mmol/L): <0.6x (low) or >4x (high), potassium (mmol/L): 0.75x (low) or 1.30x (high), sodium (mmol/L): 0.80x (low) or 1.15x (high), total protein (milligram per deciliter[mg/dL]): 1.25x (high), blood urea nitrogen(BUN) (mmol/L): 0.70x (low) or 1.60x(high). Participants were counted in the worst case if their laboratory value changes to low, or within range or no change, or high. Participants were counted in within range if their value was unchanged. Limits with 'x' are multipliers of central laboratory normal range.|Up to Week 52|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2536422|NCT03170232|Secondary|Number of Participants With Worst Case Hematology Results by Potential Clinical Importance (PCI) Criteria|Blood samples were collected. PCI ranges were, basophils(%):5x(high), eosinophils(%):2x(high), hematocrit(proportion of red blood cells in blood):0.50x(low) or 1.30x(high), hemoglobin (grams per liter):0.85x(low) or 1.20x(high), lymphocytes(%):0.80x(low) or 1.20x(high), mean corpuscle hemoglobin(picogram):0.85x(low) or 1.20x(high), mean corpuscle hemoglobin concentration(gram per deciliter):0.85x(low) or 1.10x(high), mean corpuscle volume(femtoliter):0.25x(low) or 2.00x(high), monocytes(%):0.80x(low) or 1.60x(high), platelet(x10^9 cells per liter[cells/L]):0.90x(low) or 1.10x(high), Red Blood Cell(x10^12 cells/L):0.93x(low) or 1.07x(high), neutrophil(%):0.65x(low) or 1.50x(high), White Blood Cell(x10^9 cells/L):0.70x(low) or 1.60x(high). Participants were counted in the worst case if their laboratory value changes to low/within range or no change/high and were counted in the within range if their value was unchanged. Limits with 'x' are multipliers of central laboratory normal range.|Up to Week 52|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2536423|NCT03170232|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Event (SAEs)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention was categorized as SAE. Number of participants with AEs and SAEs are summarized.|Up to Week 52|Safety Population|||Participants|||Count of Participants
2536455|NCT03169530|Secondary|Diabetes|Progression among normoglycemic and pre-diabetes individuals to American Diabetes Association (ADA)-defined diabetes.|Every 12 months for 90 months or close out, or until date of first documented occurence|The trial was closed prior to any subject competing a 12-month visit, precluding assessment of this outcome. Therefore, no data for the diabetes outcome were collected or analyzed prior to study termination.||||||
2545584|NCT02940327|Primary|CD64/163|Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.|12 hours after ECMO commencement||||percentage change||Standard Deviation|Mean
2536424|NCT03170232|Primary|Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score (Derived From SGRQ-Chronic Obstructive Pulmonary Disease Specific Tool [SGRQ-C])|The SGRQ-C is a disease-specific questionnaire designed to measure the impact of respiratory disease and its treatment on a COPD participant's health-related quality of life (HRQoL). SGRQ-C total score was converted to SGRQ total score according to manual. The SGRQ Questionnaire is a well-established, self‐completed tool, with 50 questions comprising three domains; Symptoms, Activity, and Impacts scores (each ranging from 0 to 100). SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The SGRQ total score ranges from 0 to 100, with 0 implying the best possible health status and 100 implying worst possible health status. Baseline was defined as the score recorded prior to dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the post dose visit value.|Baseline (Day 1 pre-dose), Weeks 12, 24 and 32|Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Scores on a scale||Standard Deviation|Mean
2536425|NCT03170232|Primary|Rate of Decline in Forced Expiratory Volume in One Second (FEV1)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The effect of treatment on decline of post bronchodilator FEV1 recorded during the treatment period was analyzed using a repeated measures random coefficients model with covariates of treatment group, age, sex, smoking status, baseline FEV1, body mass index (BMI), study day and the treatment group by study day interaction. The adjusted mean and standard error for rate of decline in FEV1 have been presented.|Up to Week 52|Safety Population comprised all participants randomized to treatment, excluding those who were randomized in error. Only those participants with data available at the specified time points were analyzed.|||Milliliters per year||Standard Error|Mean
2536426|NCT03170219|Secondary|Change in NT Pro BNP From Baseline to 30 Days||30 days|Data not collected.||||||
2536427|NCT03170219|Secondary|Change in Renal Function Using eGFR Baseline to 30 Days||30 days|Data not collected.||||||
2536428|NCT03170219|Secondary|Change in Breathlessness Through Day 7|On a 0-10 scale of breathlessness|7 days|Data not collected.||||||
2536429|NCT03170219|Secondary|Death at 30 Days||30 days||||Participants|||Count of Participants
2536430|NCT03170219|Secondary|30 Day ED Visit for Heart Failure||30 days|Data not collected.||||||
2536431|NCT03170219|Secondary|30 Day Heart Failure Readmission||30 days|Data not collected.||||||
2536432|NCT03170219|Secondary|Days Alive and Outside the Hospital Through 14 Days||14 days|Data not collected.||||||
2536433|NCT03170219|Secondary|Medical Costs From Randomization Through 30 Days||30 days|Data not collected.||||||
2536434|NCT03170219|Secondary|Composite Safety Endpoint of Death, Sustained Ventricular Arrhythmias, and Severe Hypokalemia||30 days|Data not collected.||||||
2536435|NCT03170219|Primary|Patient Safety Measured by Serious Adverse Events|measured by serious adverse events|30 days||||Participants|||Count of Participants
2536436|NCT03170193|Secondary|Change From Baseline in Triglycerides Concentration Over Time||Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.|Randomized participants who received study drug with available data at each time point.|||mmol/L||Standard Deviation|Mean
2536437|NCT03170193|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) Concentration Over Time||Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.|Randomized participants who received study drug with available data at each time point.|||mmol/L||Standard Deviation|Mean
2536438|NCT03170193|Secondary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration Over Time||Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.|Randomized participants who received study drug with available data at each time point.|||mmol/L||Standard Deviation|Mean
2536439|NCT03170193|Secondary|Change From Baseline in Total Cholesterol Concentration Over Time||Baseline and days 3, 6, 11, 22, 30 (all participants), and day 57 for participants assigned to the 210 mg, 420 mg, or 700 mg cohorts.|Randomized participants who received study drug with available data at each time point.|||mmol/L||Standard Deviation|Mean
2536440|NCT03170193|Secondary|Change From Baseline in Blood Alkaline Phosphatase Concentration Over Time||Baseline and days 3, 8, and 30|Participants who received at least 1 dose of study drug and with available data at each time point|||units/liter||Standard Deviation|Mean
2536441|NCT03170193|Secondary|Area Under the Curve From Time 0 to the Last Quantifiable Concentration (AUClast) for AMG 529||Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.|Participants who received AMG 529 for whom at least 1 PK parameter or endpoint was reliably estimated. Four participants were excluded from PK analyses as their profiles had < 2 samples that were above the lower limit of quantification.|||days*ng/mL||Standard Deviation|Mean
2536442|NCT03170193|Secondary|Time to Maximum Observed Concentration (Tmax) of AMG 529||Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.|Participants who received AMG 529 for whom at least 1 PK parameter or endpoint was reliably estimated. Four participants were excluded from PK analyses as their profiles had < 2 samples that were above the lower limit of quantification.|||hours||Full Range|Median
2536443|NCT03170193|Secondary|Maximum Observed Concentration (Cmax) of AMG 529||Predose and at 0.5 and 1 hour postdose (IV cohort only) and 6, 12, 24, 36, 48, 72, 120, 168, 240, 366, 504, and 696 hours postdose (all participants) and additionally at days 43 and 57 for participants assigned to the 210, 420, or 700 mg dose cohorts.|Participants who received AMG 529 for whom at least 1 PK parameter or endpoint was reliably estimated. Four participants were excluded from PK analyses as their profiles had < 2 samples that were above the lower limit of quantification.|||ng/mL||Standard Deviation|Mean
2536577|NCT03163017|Secondary|Pain as Assessed by the PROMIS Score|Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures|3 months after 3D Fluoroscopy|Data was not collected for this outcome measure.||||||
2536444|NCT03170193|Primary|Number of Participants With Adverse Events (AEs)|"Determination of the severity of adverse events was according to the following: grade 1 = mild (eg, asymptomatic or mild symptoms); grade 2 = moderate (eg, minimal intervention indicated or interferes with activity); grade 3 = severe (eg, medically significant but not immediately life-threatening, prevents daily activity, or requires treatment); grade 4 = life-threatening (ie, refers to an event in which the participant was, in the view of the investigator, at risk of death at the time of the event); and grade 5 = fatal.~A serious adverse event was defined as an adverse event that met at least 1 of the following criteria:~fatal~life threatening~required in patient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event."|From first dose up to 30 days for participants assigned to the 21 mg or 70 mg dose cohorts and up to 57 days for participants assigned to the 210 mg, 420 mg, or 700 mg dose cohorts.|Randomized participants who received at least 1 dose of AMG 529 or placebo.|||Participants|||Count of Participants
2536445|NCT03170154|Secondary|Mean Absolute IOL Misalignment|IOL misalignment was defined as the summation of IOL misplacement and IOL rotation at Month 6. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misalignment at 6 months.|Day 0 (operative), Month 6 (postoperative)|RAS, with rotation data available at operative visit and Month 6 visit|||degrees|eyes|Standard Deviation|Mean
2536446|NCT03170154|Secondary|Mean Absolute IOL Misplacement|IOL misplacement was defined as the difference between intended axis of placement and actual axis of IOL orientation on day of surgery. IOL misplacement was measured using slit lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misplacement.|Day 0 (operative)|RAS: All subjects/eyes with successful IOL implantation from the rotational subset of 6 clinical sites, with rotation data available at operative visit.|||degrees|eyes|Standard Deviation|Mean
2536447|NCT03170154|Secondary|Mean Absolute IOL Rotation|IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and Month 6. IOL rotation and measured with slit-lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL rotation at 6 months.|Day 0 (operative), Month 6 (postoperative)|Rotation Analysis Set (RAS): All subjects/eyes with successful IOL implantation from the rotational subset of 6 clinical sites, with rotation data available at operative visit and Month 6 visit.|||degrees|eyes|Standard Deviation|Mean
2536448|NCT03170154|Primary|Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye|Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. No hypothesis testing was pre-specified in the protocol.|Day 0 (operative), up to Month 12 (postoperative)|Safety Analysis Set (SAS): All subjects/study eyes with attempted implantation with the test article (successful or aborted after contact with the eye)|||percentage of subjects|||Number
2536449|NCT03170154|Primary|Percentage of Best-case Subjects Achieving Monocular BCDVA of 0.3 logMAR or Better at Month 12 Postoperative|Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic conditions at a distance of 4 meters using an Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better.|Month 12 (postoperative)|Best-Case Analysis Set (BAS): All subjects/eyes successfully implanted with the IOL that had at least 1 postoperative visit, no preoperative ocular pathology, no macular degeneration at any time, and no previous surgery for the correction of refractive errors, with data at visit.|||percentage of subjects|eyes|95% Confidence Interval|Number
2536450|NCT03170154|Primary|Percentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at Month 12 Postoperative|Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better.|Month 12 (postoperative)|All-Implanted Subjects (AAS): All subjects/eyes with successful IOL implantation and data at visit|||percentage of subjects|eyes|95% Confidence Interval|Number
2536451|NCT03169530|Other Pre-specified|Pre-Diabetes|Progression among normoglycemic individuals to ADA-defined pre-diabetes.|Every 12 months for 90 months or closeout|The trial was closed prior to any subject competing a 12-month visit, precluding assessment of this outcome. Therefore, no data for this outcome were collected or analyzed prior to study termination.||||||
2536452|NCT03169530|Other Pre-specified|Cardiovascular Death|Time from baseline to cardiovascular mortality.|Every 3 months for 90 months or closeout, or date of death|The trial was closed prior to any subject competing a 3-month visit, precluding assessment of this outcome. Therefore, no data for this outcome were collected or analyzed prior to study termination. No subjects died prior to completion of a 3-month visit.||||||
2536453|NCT03169530|Other Pre-specified|Components of Primary Composite Endpoint|Time from baseline to the first occurrence of each of the components of primary outcome (5 outcomes).|Every 3 months for up to 90 months or close out, or until date of death|The trial was closed prior to any subject competing a 3-month visit, precluding assessment of these outcomes. Therefore, no data were collected or analyzed prior to study termination. No subjects died during the trial.||||||
2536454|NCT03169530|Other Pre-specified|Hard Cardiovascular Disease or Death|Time from baseline to a composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, or cardiovascular death.|Every 3 months for 90 month or close out, or until date of death|The trial was closed prior to any subject competing a 3-month visit, precluding assessment of this outcome. Therefore, no data for this outcome were collected or analyzed prior to study termination. No subjects died during the trial.||||||
2536578|NCT03163017|Secondary|Alignment as Assessed by the AOFAS Score|The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores|6 months after 3D Fluoroscopy|Data was not collected for this outcome measure.||||||
2536456|NCT03169530|Secondary|Cardiovascular Disease|Time from baseline to a composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalization for angina, coronary/carotid revascularization, or cardiovascular mortality.|Every 3 months for up to 90 months or close out, or until date of death|The trial was closed prior to any subject competing a 3-month visit, precluding assessment of this secondary outcome. Therefore, no data for this outcome were collected or analyzed prior to study termination. No subjects died during the trial.||||||
2536457|NCT03169530|Primary|Cardiovascular Disease or Death|Time from baseline to a composite endpoint comprised of the first occurrence of a non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalization for angina, coronary/carotid revascularization, or all-cause mortality.|Every 3 months for up to 90 months or close out, or until date of death|The trial was closed prior to any subject competing a 3-month visit, precluding assessment of the primary outcome. Therefore, no data for the CV disease outcome were collected or analyzed prior to study termination. No subjects died during the trial.||||||
2536458|NCT03169153|Primary|Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens|Contact lens was removed aseptically from the eye. Total lipid (fatty deposits) uptake, defined as total amount of lipids (surface and bulk) absorbed/adsorbed and extracted, was measured in micrograms. A lower value indicates better results. Only one lens from each subject contributed to the analysis.|Day 30 after 10 hours of wear, each product|Full Analysis Set with non-missing response|||micrograms (μg)||Standard Deviation|Mean
2536459|NCT03169062|Secondary|Mean Correlation Coefficient of Gating|The 30 ms cardiac EKG trace will be extracted for each of the projections. Then, a Pearson correlation coefficient will be calculated for each of the projections relative to the first x-ray projection. The mean of the Pearson correlation coefficients will then calculated and served as an estimate of the timing precision of each projection set for each patient. The mean and standard deviation of the correlation coefficients will be reported.|At the conclusion of all data collection, 6 months post study completion||||unitless||Standard Deviation|Mean
2536460|NCT03169062|Primary|Comparison of CT Derived CACS and Tomosynthesis Scores Correlation|Linear regression and Bland-Altman analysis will be used to examine the relationship between the CT derived CACS and tomosynthesis scores to determine the correlation|1 year|Visualization of coronary artery calcium was limited given the small effective angular span of the current hardware, thus calcium scoring was not performed. Since calcium scoring could not be performed, the planned analysis could not be conducted.||||||
2536461|NCT03168919|Other Pre-specified|Time to Progression|Percentage change of the Cho/NAA, ADC and nCBV from baseline to the end of radiation therapy, RT will be used for assessment of time to progression.|From Baseline through 24 months.||||days||Full Range|Mean
2536462|NCT03168919|Secondary|Changes of Tumor Angiogenesis|Perfusion MRI will be used for assessment of tumor angiogenesis (with median normalized cerbral blood volume, nCBV) during the course of fractionated radiation treatment.|From baseline to 6 weeks|Results of only 2 subjects was included.|||mL/100 gm of brain tissue||Full Range|Mean
2536463|NCT03168919|Secondary|Changes of Tumor Volume|MRI will be used for assessment of measures tumor volume.|From baseline Up to 6 weeks|Measurements performed only in 2 subjects .|||cm3||Full Range|Mean
2536464|NCT03168919|Secondary|Changes of Tumor Cellularity|Diffusion MRI will be used for assessment of measures tumor cellularity (with minimum apparent diffusion co-efficent, ADC) during the course of fractionated radiation treatment.|From baseline to 6 weeks|Only 3 subjects completed the treatment.|||mm^2/sec||Full Range|Mean
2536465|NCT03168919|Primary|Number of Participants With the Changes of the Chemical Environment of the Tumor|Multiple MRI techniques will be used to assess chemical environment (Cho/NAA) of the tumor during the course of fractionated radiation treatment.|From Baseline to 6 weeks.|The number of participants dropped from 5 to 3 because 2 participants withdrew from the study. The chemical evaluation could not be evaluated due to poor quality imaging.||||||
2536466|NCT03168906|Secondary|All Cause of Mortality at 26 Months|Death at 26 months from Baseline due to any cause|Baseline to 26 months|||||||
2536467|NCT03168906|Secondary|Renal Response in Patients With Maintained Hematologic Responses After 24 Monthly Treatments.|A renal response is a ≥ 30% decrease in proteinuria or drop of proteinuria below 0.5 g/24h in the absence of renal progression.|Baseline to 26 months|||||||
2536468|NCT03168906|Secondary|Time to ≥ 40% Reduction in eGFR|Months to ≥ 40% reduction in estimated glomerular filtration rate|Baseline to 13 Months|||||||
2536469|NCT03168906|Secondary|Time to Doubling of Creatinine|Months to doubling of serum creatinine|Baseline to 13 Months|||||||
2536470|NCT03168906|Secondary|Time to eGFR ≤ 15 or Dialysis|Months to estimated Glomerular Filtration Rate ≤ 15 or dialysis|Baseline to 13 Months|||||||
2536471|NCT03168906|Secondary|Time to CKD 4 or 5|Months to Chronic Kidney Disease level 4 or 5|Baseline to 13 Months|||||||
2536472|NCT03168906|Secondary|Measured GFR at Study Entry|The aim of this study is to assess the performance of CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) creatinine in comparison to iothalamate clearance measured in AL amyloidosis patients. Iothalamate will be given subcutaneously. Urine and plasma samples will then be obtained. All laboratory tests for samples obtained for GFR measurement will be performed at Mayo Clinic Rochester. Quantification of iothalamate in urine and plasma will be performed using a tandem mass spectrometric method.|Baseline|Trial was closed prior to completion, therefore data were not collected.||||||
2536473|NCT03168906|Primary|Confirmed Renal Response After Treatment With NEOD001|A renal response is a ≥ 30% reduction in proteinuria in the absence of a ≥ 25% decrease in eGFR. A confirmed renal response is one that has been documented as present one month after 12 monthly treatments.|Baseline to 13 Months|Trial was closed prior to completion, therefore data were not collected.||||||
2536474|NCT03168841|Secondary|Secondary Endpoint - Safety (Occurrence of Adverse Events: Type and Frequency)|The secondary safety endpoint is the occurrence of adverse events (type and frequency).|50 weeks|||||||
2536475|NCT03168841|Secondary|Secondary Endpoint - Efficacy|The second secondary efficacy end point is clinical cure, defined as 0% clinical involvement of the target toenail.|50 weeks|||||||
2536476|NCT03168841|Secondary|Secondary Endpoint - Efficacy|The first secondary efficacy end point is mycological cure, defined as negative KOH examination and negative fungal culture of the target toenail sample.|50 weeks||||Participants|||Count of Participants
2536478|NCT03168542|Secondary|Subject's Responses to Individual Item 10|"Subjects responses to individual item Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Opinion Of These Contact Lenses?. This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported."|15 Minutes Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||Percentage of participants|||Number
2536479|NCT03168542|Secondary|Subject's Responses to Individual Item 9|"Subjects responses to individual item How would you rate your overall visual performance with the study contact lens?. This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported."|15 Minutes Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||Percentage of participants|||Number
2536480|NCT03168542|Secondary|Subject's Responses to Individual Item 8|"Subjects responses to individual item Considering your experience with the study contact lens, how excited are you about this lens being available to purchase?. This item had a response set of Very Excited, Excited, Unsure, Unexcited and Very Unexcited. The percentage of subject's in each response category was reported."|15 Minutes Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||Percentage of participants|||Number
2536481|NCT03168542|Secondary|Subject's Responses to Individual Item 7|"Subjects responses to individual item How did the new lens you tried as a part of this clinical study Compare To Your Current Vision Correction Solutions?. This item had a response set of Much better, somewhat better, about the same, somewhat worse and much worse. The percentage of subject's in each response category was reported."|15 Minutes Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||Percentage of participants|||Number
2536482|NCT03168542|Secondary|Subject's Responses to Individual Item 6|"Subjects responses to individual item What Are Your Current Vision Correction Solutions?. The percentage of subject's in each response category was reported."|15 Minutes Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||Percentage of participants|||Number
2536483|NCT03168542|Secondary|Subject's Responses to Individual Item 5|"Subjects responses to individual item If You Were To Purchase The Study Contact Lenses, With What Frequency Would You Expect To Wear Them?. This item had a response set of All of the time, Usually, Frequently, Sometimes, Rarely and never. The percentage of subject's in each response category was reported."|15 Minutes Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||Percentage of participants|||Number
2536484|NCT03168542|Secondary|Subject's Responses to Individual Item 4|"Subjects responses to individual item Where Would You Expect To Go Looking For Information About This Contact Lens? Please Select All That Apply.. The percentage of subject's in each response category was reported."|15 Minutes Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||Percentage of participants|||Number
2536485|NCT03168542|Secondary|Subject's Responses to Individual Item 3|"Subjects responses to individual item Please Think About Your Experience Today With The Study Contact Lenses. Please Indicate How You Satisfied You Are With The Overall Contact Lens Fitting Process?. This item had a response set of very satisfied, satisfied, unsure, dissatisfied and very dissatisfied. The percentage of subject's in each response category was reported"|15 Minutes Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||Percentage of participants|||Number
2536486|NCT03168542|Secondary|Subject's Responses to Individual Item 2|"Subjects responses to individual item Based On Your Experience Today, How Likely Are You To Purchase This Contact Lens?. This item had a response set of extremely likely, very likely, somewhat likely, slightly likely and not at all likely. The percentage of subject's in each response category was reported."|15 Minutes Post Lens Insertion|All subjects that completed the study without a major protocol deviation|||Percentage of participants|||Number
2536487|NCT03168542|Secondary|Subject's Responses to Individual Item 1|"Subjects responses to individual item Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Satisfaction Of These Contact Lenses?. This item had a response set of extremely satisfied, very satisfied, moderately satisfied, slightly satisfied and not at all satisfied. The percentage of subject's in each response category was reported."|15 Minutes Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||Percentage of participants|||Number
2536488|NCT03168542|Primary|Number of Fitting Modifications to Optimize Vision|The ECP followed the fitting guide to assess the vision provided by the study lenses and determined if a lens change was needed. The ECP modified the lenses based upon the subject's responses in accordance with the Fitting Guide. Two modifications were allowed. The number of modifications required by the ECP to optimize vision was recorded.|15 Minutes Post Lens Fitting|All subjects that completed the study without a major protocol deviation.|||Lens|Eyes|Standard Deviation|Mean
2536489|NCT03168425|Secondary|Pain: Frequency That Participants Reported Uncontrolled Pain|"Frequency that participants reported uncontrolled pain~Pain scores were examined based on how many negative responses indicating worse pain were reported to the five questions relating to analgesic adequacy. Thus participants could have a score that ranged from 0 to 5.~Question 1 - I was discharged with too few opioid pills (Yes=1, No=0) Question 2 - Overall, my pain is poorly controlled by these medications (Yes=1, No=0) Question 3 - Overall, my pain from delivery has been worse than expected (Yes=1, No=0) Question 4 - Pain interfered significantly with my ability to do normal activities (Yes=1, No=0) Question 5 - Since discharge, I needed more opioid than what was expected (Yes=1, No=0)"|4 weeks postpartum||||score on a scale||Inter-Quartile Range|Median
2536490|NCT03168425|Primary|Unused Opioids|oxycodone 5mg tablet leftover from prescription at discharge|4 weeks postpartum||||oxycodone 5mg tablets||Inter-Quartile Range|Median
2536491|NCT03168308|Secondary|Number of Participants Who Needed Rescue Sugammadex After Initial Reversal of Neuromuscular Blockade|To determine if reversal with sugammadex versus neostigmine requires an additional dose of sugammadex rescue after initial reversal of neuromuscular blockade.|From time of reversal to 80 minutes after arrival in the post-anesthesia care unit, approximately 1-2 hours.||||Participants|||Count of Participants
2536492|NCT03168308|Secondary|Time to Complete Reversal of Neuromuscular Blockade|The time from the administration of the blinded reversal syringe until complete reversal of neuromuscular blockade (train of four ratio ≥0.9).|From time of reversal to complete reversal of neuromuscular blockade (train of four ratio ≥0.9), approximately 1 hour||||minutes||Inter-Quartile Range|Mean
2536496|NCT03168295|Primary|Change in Endogenous Glucose Production (EGP)|Renal transplant subjects with native kidneys intact underwent measurement of EGP with an 8 hour infusion of 3-3H-glucose on 2 separate days with the administration in random order of either dapagliflozin 10mg or placebo after 3 hours of the tracer equilibration period. The equilibration at 3 hours was considered the baseline measurement. Measurement of change in endogenous glucose production was obtained for all subjects.|baseline and 240-300 minutes|The control group did not have renal surgery and were only administered the dapagliflozin, not the placebo, so no participants show for baseline or 240 to 300 minutes for placebo measurements, only for dapagliflozin.|||mg/kg.min||Standard Deviation|Mean
2536497|NCT03168022|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Treatment A and Treatment B, Administered as 1 x 2.8 mg TNX-102 SL Under Fasting Conditions.|The MedDRA® dictionary was used to classify all TEAEs reported during the study by System Organ Class (SOC) and Preferred Term (PT).|Continuously until the end (day 5) of each study period + 8-10 days after end of last period (total duration: about 1 month)|All subjects who received at least one dose of either Treatment A or Treatment comprised the safety population (N = 43). Of these, 1 subject discontinued from the study after one dose of Treatment B and was replaced with a stand-by. A total 42 subjects completed the study as per protocol.|||Participants|||Count of Participants
2536498|NCT03168022|Primary|Mean Plasma Concentration (AUC) of Cyclobenzaprine|Blood samples were collected prior to drug administration and 0.083 (5 min), 0.167 (10 min),0.333 (20 min), 0.500 (30 min), 0.750 (45 min), 1.00, 1.50, 2.00, 2.50, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 5.00, 5.50, 6.00, 8.00, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0, and 96.0 hours post-dose in each period.|0 to 96 hours|Subjects who completed the study and for whom the PK profile could be adequately characterized were included in the outcome measures.|||pg*h/mL||Standard Deviation|Mean
2536499|NCT03167541|Secondary|Occurrence of Adverse Events (AEs)|"Intensity was determined by the Investigator~Mild = AE does not limit usual activities; subject may experience slight discomfort.~Moderate = AE results in some limitation of usual activities; subject may experience significant discomfort.~Severe = AE results in an inability to carry out usual activities; subject may experience intolerable discomfort or pain.~Relationship to Investigational Medicinal Products (IMP)~Certain = AE was definitely caused by IMP. Probable = Most likely that the AE was caused by IMP. Possible = Reasonable suspicion that the AE was caused by IMP Unlikely = Slight, but remote, chance that the AE was caused by IMP but the balance of judgment is that it was most likely not due to the IMP.~Unrelated = No possibility that the AE was caused by IMP Un-assessable/Unclassified = Insufficient information to be able to make an assessment.~Conditional/Unclassified = Insufficient information to make an assessment at present."|Up to follow-up day 7|Safety population|||Number of events|||Number
2536500|NCT03167541|Secondary|Plasma Concentration at Each Planned Nominal Time-point (Cn)||Pre-dose and at 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 15 mins, 1 hour 30 mins, 1 hour 45 mins, 2 hours, 2 hours 30 mins, 3, 4, 6, 9, 15 (Day 1), 24, 36 (Day 2), 48 (Day 3) and 72 (Day 4) hours post-dose|PK Parameter Summary Set population|||μg/mL||Standard Deviation|Mean
2536501|NCT03167541|Secondary|Plasma Concentration (Elimination) Half-life (T1/2)||Pre-dose and at 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 15 mins, 1 hour 30 mins, 1 hour 45 mins, 2 hours, 2 hours 30 mins, 3, 4, 6, 9, 15 (Day 1), 24, 36 (Day 2), 48 (Day 3) and 72 (Day 4) hours post-dose|PK Parameter Summary Set population|||hour||Standard Deviation|Mean
2536502|NCT03167541|Secondary|Time Until Cmax is First Achieved (Tmax)||Pre-dose and at 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 15 mins, 1 hour 30 mins, 1 hour 45 mins, 2 hours, 2 hours 30 mins, 3, 4, 6, 9, 15 (Day 1), 24, 36 (Day 2), 48 (Day 3) and 72 (Day 4) hours post-dose|PK Parameter Summary Set population|||hour||Standard Deviation|Mean
2536503|NCT03167541|Secondary|Residual Area (AUC%Extrap)|AUC%extrap represents the percentage of the AUC0-inf obtained by extrapolation, calculated as (1 - [AUC0-last/AUC0-inf]) multiplied by 100.|Pre-dose and at 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 15 mins, 1 hour 30 mins, 1 hour 45 mins, 2 hours, 2 hours 30 mins, 3, 4, 6, 9, 15 (Day 1), 24, 36 (Day 2), 48 (Day 3) and 72 (Day 4) hours post-dose|PK Parameter Summary Set population|||Percentage of AUC||Standard Deviation|Mean
2536504|NCT03167541|Secondary|Area Under the Plasma Concentration Curve From Administration to Infinity (AUC0-inf)|Area under the plasma concentration curve from administration to infinity (AUC0-inf) was calculated as AUC0-t + (Ct/Kel) where Ct was the last quantifiable concentration at time t|Pre-dose and at 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 15 mins, 1 hour 30 mins, 1 hour 45 mins, 2 hours, 2 hours 30 mins, 3, 4, 6, 9, 15 (Day 1), 24, 36 (Day 2), 48 (Day 3) and 72 (Day 4) hours post-dose|PK Parameter Summary Set Population|||h*μg/mL||Standard Deviation|Mean
2536505|NCT03167541|Secondary|Elimination Rate Constant (Kel)|Elimination Rate Constant (Kel) was calculated as the absolute value of the log-linear regression slope of the elimination phase (logged) over time (linear) using the post Cmax concentrations [at least 3 non-below the limit of quantification (BLQ)] that maximised the adjusted R2.|Pre-dose and at 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 15 mins, 1 hour 30 mins, 1 hour 45 mins, 2 hours, 2 hours 30 mins, 3, 4, 6, 9, 15 (Day 1), 24, 36 (Day 2), 48 (Day 3) and 72 (Day 4) hours post-dose|PK Parameter Summary Set Population|||1/h||Standard Deviation|Mean
2536506|NCT03167541|Primary|Maximum Plasma Concentration (Cmax)||Pre-dose and at 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 15 mins, 1 hour 30 mins, 1 hour 45 mins, 2 hours, 2 hours 30 mins, 3, 4, 6, 9, 15 (Day 1), 24, 36 (Day 2), 48 (Day 3) and 72 (Day 4) hours post-dose|PK Parameter Summary Set Population|||μg/mL||Standard Deviation|Mean
2536507|NCT03167541|Primary|Area Under Plasma Concentration-time at Time t (AUC0-t)|AUC0-t defines Area under the plasma concentration-time curve (AUC) from administration to the last quantifiable concentration at time t.|Pre-dose and at 15 mins, 30 mins, 45 mins, 1 hour, 1 hour 15 mins, 1 hour 30 mins, 1 hour 45 mins, 2 hours, 2 hours 30 mins, 3, 4, 6, 9, 15 (Day 1), 24, 36 (Day 2), 48 (Day 3) and 72 (Day 4) hours post-dose|Pharmacokinetic (PK) Parameter Summary Set Population includes all subjects from the PK dataset with evaluable PK parameters for each treatment period.|||h*μg/mL||Standard Deviation|Mean
2536508|NCT03166618|Secondary|"Percentage of Participants Improved or Much Improved as Assessed by the Participant Using the GAIS"|The participant will assess their temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who assess themselves as 2=much improved or 1=improved will be reported.|Month 3|Up to 189 subjects were planned; 1 subject was enrolled in the control_No Treatment arm. Terminated study; no treatment was administered and no analyses were conducted.||||||
2536509|NCT03166618|Secondary|"Percentage of Participants Improved or Much Improved as Assessed by the Evaluating Investigator Using the Global Aesthetic Improvement Scale (GAIS)"|The Evaluating Investigator will assess the participant's temple area using the GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. The percentage of participants who the Evaluating Investigator assesses as 2=much improved or 1=improved will be reported.|Month 3|Up to 189 subjects were planned; 1 subject was enrolled in the control_No Treatment arm. Terminated study; no treatment was administered and no analyses were conducted.||||||
2536510|NCT03166618|Primary|Percentage of Participants With at Least a 1-Point Improvement (Decrease) in Both Temples as Assessed by the Evaluating Investigator Using the Allergan Temple Hollowing Scale (ATHS)|The Evaluating Investigator will assess the participant's temple hollowing using the ATHS 5-point scale where: 0=convex, rounded temple to 4=severe, deeply recessed, sunken appearance. A 1-point decrease from Baseline indicates improvement.|Change from Baseline to Month 3|Up to 189 subjects were planned; 1 subject was enrolled in the control_No Treatment arm. Terminated study; no treatment was administered and no analyses were conducted.||||||
2536511|NCT03166215|Secondary|Percentage of Participants With at Least 1 Markedly Abnormal Value for Electrocardiogram (ECG) Parameters After TAK-935|A 12-lead ECG was performed. Markedly abnormal values during treatment period were categorized as: ECG ventricular rate <50->120, PR Interval, (msec) <=80->=200, QRS Duration, (msec) <=80->=180, QT Interval, (msec) <=50->=460, QTcF Interval, (msec) <=50->=500 OR >=30 change from baseline and >=450 milliseconds, RR interval <600->=1440.|From first dose up to last dose (up to Day 85)|Safety Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug. Data reported is the data available for the specific parameter.|||percentage of participants|||Number
2536512|NCT03166215|Secondary|Percentage of Participants With at Least 1 Markedly Abnormal Value for Vital Signs After TAK-935|Vital signs included heart rate, blood pressure and body temperature. markedly abnormal values during treatment period were categorized as: heart rate 1,3 and 5 min standing (beats/min) <50->120, systolic blood pressure 1,3 and 5 min standing (mmHg) <85->180, diastolic blood pressure 1,3 and 5 min standing (mmHg) <50->110 and body temperature (degree centigrade) <35.6- >37.7. Only categories with values have been reported.|From first dose up to 30 days post last dose (approximately up 120 days)|Safety Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug. Data reported is the data available for the specific parameter.|||percentage of participants|||Number
2536513|NCT03166215|Secondary|Percentage of Participants With at Least 1 Markedly Abnormal Value for Clinical Laboratory Evaluations After TAK-935|Clinical Laboratory parameters: hematology, serum chemistry and urinalysis. Participants with at least 1 markedly abnormal values during treatment period were reported: Erythrocytes: <0.8xLLN->1.5xULN, Hematocrit: <0.8x LLN >1.2xULN,Hemoglobin: <0.8xLLN->1.2xULN Leukocytes: <0.5xLLN, Platelets (10^9/L): <75x10^9/L->600x10^9/L, Prothrombin Ratio: >1.5xULN, Alanine Aminotransferase: >3xULN, Albumin:<25 g/L, Alkaline Phosphatase: >3xULN,Alpha-1 Acid Glycoprotein: <47 mg/DL->125 mg/DL, Aspartate Aminotransferase:>3xULN, Bicarbonate:<8.0 mmol/L, Calcium:<1.75 mmol/L->2.88 mmol/L, Chloride:<75 mmol/L->126 mmol/L, Cholesterol: >7.72,Creatine Kinase:>5xULN, Creatinine:>177 umol/L, Gamma Glutamyl Transferase: >3xULN, Glucose:<2.8 mmol/L- >19.4 mmol/L,HDL Cholesterol: <1.04 mmol/L->1.55 mmol/L, LDL Cholesterol: <1.30 mmol/L->4.14 mmol/L, Potassium:<3.0 mmol/L->6.0 mEq/L, Protein:<0.8xLLN->1.2 x ULN, Sodium: <130 mmol/L->150 mmol/L, Triglycerides: >2.5xULN, Urea Nitrogen: >10.7 mmol/L.|From first dose up to last dose (up to Day 85)|Safety Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug. Data reported is the data available for the specific parameter.|||percentage of participants|||Number
2536514|NCT03166215|Secondary|Ctrough,ss: Plasma Concentration Immediately Prior to Dosing for TAK-935 at Steady State||Days 1, 11, 21; Days 31, 41 and 85 pre-dose|PK Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or M-I plasma concentration.|||ng/mL||Standard Deviation|Mean
2536515|NCT03166215|Secondary|Cav,ss: Average Plasma Concentration During a Dosing Interval at Steady State for TAK-935||Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dose|PK Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or M-I plasma concentration.|||ng/mL||Standard Deviation|Mean
2536516|NCT03166215|Secondary|AUC0-tau,ss: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for TAK-935 at Steady State||Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dose|PK Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or M-I plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2536517|NCT03166215|Secondary|Cmax,ss: Maximum Observed Plasma Concentration for TAK-935 at Steady State||Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dose|PK Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or M-I plasma concentration.|||ng/mL||Standard Deviation|Mean
2536518|NCT03166215|Secondary|Absorption Rate Constant (Ka) for TAK-935||Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dose|PK Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or M-I plasma concentration.|||1/hr||Standard Deviation|Mean
2536519|NCT03166215|Secondary|Apparent Volume of Distribution (Vz/F) of Central Compartment (Vc) and Peripheral Compartment (Vp) for TAK-935 Calculated Using the Observed Value of the Last Quantifiable Concentration||Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dose|PK Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or M-I plasma concentration.|||L||Standard Deviation|Mean
2536579|NCT03163017|Secondary|Function as Assessed by the AOFAS Score|The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores|6 months after 3D Fluoroscopy|Data was not collected for this outcome measure.||||||
2536520|NCT03166215|Secondary|Drug Clearance (CL) and Intercompartmental Clearance (Q) for TAK-935 Calculated Using the Observed Value of the Last Quantifiable Concentration||Day 1 pre-dose and at multiple timepoints (up to 5 hours) post-dose; Days 11 and 21 pre-dose and 1-hour post-dose; Days 31, 41, and 85 pre-dose|Pharmacokinetic (PK) Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug and have at least 1 post-dose measurable TAK-935 or metabolite of TAK-935 (M-I) plasma concentration.|||L/hr||Standard Deviation|Mean
2536521|NCT03166215|Primary|Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE), as Reported by the Participants or Participant's Caregivers or Observed by the Investigator, After TAK-935 Treatment|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug|From first dose up to 30 days post last dose (approximately up to 120 days)|Safety Analysis Set for Parts 1 and 2 included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2536522|NCT03166124|Secondary|Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm|Glucodynamics: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure.|Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose|All participants who received at least one dose of study drug and completed at least one clamp procedure.|||milligram per kilogram (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
2536523|NCT03166124|Primary|Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) for Each Treatment Arm|Pharmacokinetics: Insulin lispro AUC from time zero to 10 hours postdose [AUC(0-10h)] for each treatment arm.|Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose|All participants who received at least one dose of study drug and have measurable insulin lispro concentrations.|||picomole * hour per Liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2536524|NCT03165981|Secondary|Number of Participants With Medical Care Utilization - Visit 1 and 2 Combined|Proportion of children with medical care utilization (telephone call, medical office visit, emergency department visit, or hospital admission) for fever on day 1 and/or day 2 following Visit 1 and Visit 2 combined.|2 days post administration|Per Protocol Population|||Participants|||Count of Participants
2536525|NCT03165981|Secondary|Number of Participants With Medical Care Utilization - Visit 2|Proportion of children with medical care utilization (telephone call, medical office visit, emergency department visit, or hospital admission) for fever on day 1 and/or day 2 following Visit 2.|2 days post administration|Per Protocol Population|||Participants|||Count of Participants
2536526|NCT03165981|Secondary|Number of Participants With Medical Care Utilization - Visit 1|Proportion of children with medical care utilization (telephone call, medical office visit, emergency department visit, or hospital admission) for fever on day 1 and/or day 2 following Visit 1.|2 days post administration|Per Protocol Population|||Participants|||Count of Participants
2536527|NCT03165981|Secondary|Duration of Fever - Visit 1 and 2 Combined|Average number of consecutive days of fever (temperature ≥ 38.0°C or ≥ 100.4°F) per subject for fever starting on day 1 or 2 following and Visit 1 and Visit 2 combined. Note: fever starting on day 1 or 2 could continue through day 8.|8 days post administration|Per Protocol Population|||Fever Days||Full Range|Mean
2536528|NCT03165981|Secondary|Duration of Fever - Visit 2|Average number of consecutive days of fever (temperature ≥ 38.0°C or ≥ 100.4°F) per subject for fever starting on day 1 or 2 following Visit 2. Note: fever starting on day 1 or 2 could continue through day 8.|8 days post administration|Per Protocol Population|||Fever Days||Full Range|Mean
2536529|NCT03165981|Secondary|Duration of Fever - Visit 1|Average number of consecutive days of fever (temperature ≥ 38.0°C or ≥ 100.4°F) per subject for fever starting on day 1 or 2 following Visit 1. Note: fever starting on day 1 or 2 could continue through day 8.|8 days post administration|Per Protocol Population|||Fever Days||Full Range|Mean
2536530|NCT03165981|Secondary|Number of Participants With Grade 2 and/or 3 Following Visit 1 and Visit 2|Proportions of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1 and Visit 2 combined.|2 days post administration|Per Protocol Population|||Participants|||Count of Participants
2536531|NCT03165981|Secondary|Number of Participants With Grade 2 and/or 3 Following Visit 2|Proportions of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 2.|2 days post administration|Per Protocol Population|||Participants|||Count of Participants
2536532|NCT03165981|Secondary|Number of Participants With Grade 2 and/or 3 Following Visit 1|Proportions of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1. (Moderate/severe fever: ≥ 38.6°C or ≥ 101.4°F)|2 days post administration|Per Protocol Population|||Participants|||Count of Participants
2536533|NCT03165981|Secondary|Number of Participants With Fever Visit 2|Proportion of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 2|2 days post administration|Per Protocol Population|||Participants|||Count of Participants
2536534|NCT03165981|Secondary|Number of Participants With Fever Visit 1|Proportion of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1|2 days post administration|Per Protocol Population|||Participants|||Count of Participants
2536535|NCT03165981|Primary|Number of Participants With Fever Following Vaccination|Proportion of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 and/or Visit 2.|2 days post administration|Per Protocol Population|||Participants|||Count of Participants
2536580|NCT03163017|Secondary|Pain as Assessed by the AOFAS Score|The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores|6 months after 3D Fluoroscopy|Data was not collected for this outcome measure.||||||
2536581|NCT03163017|Secondary|Alignment as Assessed by the AOFAS Score|The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores|3 months after 3D Fluoroscopy|Data was not collected for this outcome measure.||||||
2536536|NCT03165747|Secondary|Study Retention Rate.|The number of participants who complete all study visits, phone calls, and maintain drug compliance. Retention will be documented via conventional Consolidated Standards of Reporting Trials (CONSORT) criteria and documentation of missed study visits, missed telephone communications and compliance with study drug administration. All data will be maintained in the CRFs.|Up to 12 months|The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.||||||
2536537|NCT03165747|Secondary|Gastrointestinal Symptom Rating|Study drug tolerance will be assessed by obtaining serial measures of the Gastrointestinal Symptom Rating Scale (GSRS). These will be obtained with in-person interviews at the baseline and month 6 and 12 visits and by telephone contact with all subjects by the study coordinator every 2 weeks. Data will be analyzed within the 5 symptom domains depicting symptoms related to gastric reflux, abdominal pain, indigestion, diarrhea, and constipation.The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. A GSRS total score, the sum of all 5 domains, will also be assessed.|Every two weeks during the study 12-months|The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.||||||
2536538|NCT03165747|Secondary|Number of Unused Study Drug Sachets.|"This will be determined by contacts (twice monthly telephone or at research center visits) of the study coordinator with each subject and responses to three standardized question areas: 1) Are you having any difficulty, problems or new symptoms with the study medication? 2) If yes, What has the problem been? and 3) Have you missed any of your study drug doses, and if so how many in the previous 2 week period? Appropriate notations based on subject responses will be documented in the case report form (CRF). Subjects will be instructed at study entry and reminded via serial contacts to return all of their used and unused drug sachets at each research center visit. Unused and used study drug sachets will be tallied and recorded in the CRF by the study coordinator serially for the entire study."|Every two weeks during the study 12-months|The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.||||||
2536539|NCT03165747|Secondary|Change in Serum Interleukin-17 (IL-17) Concentrations.|Up to approximately 50 mL of fasted blood will be collected at every visit from a peripheral vein.|Baseline, 6-month, 12-month visits|The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.||||||
2536540|NCT03165747|Secondary|Change in Serum Tumor Necrosis Factor (TNF)|Up to approximately 50 mL of fasted blood will be collected at every visit from a peripheral vein.|Baseline, 6-month, 12-month visits|The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.||||||
2536541|NCT03165747|Secondary|Change in Serum Osteoprotegrin (OPG) Concentrations.|Up to approximately 50 mL of fasted blood will be collected at every visit from a peripheral vein.|Baseline, 6-month, 12-month visits|The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.||||||
2536542|NCT03165747|Secondary|Change in Serum Free Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL) Concentrations.|Up to approximately 50 mL of fasted blood will be collected at every visit from a peripheral vein.|Baseline, 6-month, 12-month visits|The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.||||||
2536543|NCT03165747|Secondary|Change in Serum Procollagen Type I N Propeptide (PINP) - a Marker of Bone Formation - Concentrations.|Up to approximately 50 mL of fasted blood will be collected at every visit from a peripheral vein.|Baseline, 6-month, 12-month visits|The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.||||||
2536544|NCT03165747|Secondary|Change in Serum Collagen Type 1 Cross-linked C-telopeptide (CTX) Concentrations (a Marker of Bone Resorption).|Up to approximately 50 mL of fasted blood will be collected at every visit from a peripheral vein.|Baseline, 6-month, 12-month visits|The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.||||||
2536545|NCT03165747|Secondary|Change in Bone Density of the Non-dominant Hip (Femoral Neck and Total Hip Area) as Measured by DEXA (Dual Energy X-ray Absorptiometry).|All DEXA scans will be performed on the same device using a GE Lunar iDEXA machine. Participants will be asked to lie still on a scanning table with their arms at their sides for approximately 10 minutes.|Baseline and 12-month visit.|The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.||||||
2536582|NCT03163017|Secondary|Function as Assessed by the AOFAS Score|The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores|3 months after 3D Fluoroscopy|Data was not collected for this outcome measure.||||||
2536583|NCT03163017|Secondary|Pain as Assessed by the AOFAS Score|The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores|3 months after 3D Fluoroscopy|Data was not collected for this outcome measure.||||||
2536546|NCT03165747|Primary|Change in Bone Mineral Density (BMD) of the Lumbar Spine (L1-L4 Segment) as Measured by Dual Energy X-ray Absorptiometry (DEXA)|All DEXA scans will be performed on the same device using a GE Lunar iDEXA machine. Participants will be asked to lie still on a scanning table with their arms at their sides for approximately 10 minutes.|Baseline and 12-month visit.|The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.||||||
2536547|NCT03165175|Secondary|Preparedness to Talk About Misuse|Two investigator-developed items were used to assess the level of preparedness to talk to others (i.e., chain of command, doctor) about concerns related to one's own possible prescription drug misuse. The scale ranged from 1-5 with higher scores indicating a better outcome.|Baseline and 1 month||||score on a scale||Standard Deviation|Mean
2536548|NCT03165175|Secondary|Prescription Drug Misuse-related Knowledge|Mean number of correct knowledge items. Twenty-three multiple choice knowledge items assessed the participant's level of knowledge of the definition of misuse and related educational points. Possible range is 0-23 with higher scores reflecting higher knowledge levels.|Baseline and 1 month||||correct items||Standard Deviation|Mean
2536549|NCT03165175|Secondary|Prescription Drug Misuse-related Attitudes|A scale score for items from the 8-item Prescription Drug Attitudes Questionnaire (PDAQ; Bodenlos et al., 2014), which were adapted by the investigators for the military. The scores range from 1-5 with higher scores indicating a worse outcome.|Baseline and 1 month||||score on a scale||Standard Deviation|Mean
2536550|NCT03165175|Secondary|Pain Medication Questionnaire (PMQ) Shortened Scale|Mean PMQ scale score as an indicator of prescription drug misuse. This 5-item scale was adapted from a brief scale previously used by Morasco and Dobscha (2008), which is actually a subset of the Pain Medication Questionnaire (PMQ) scale (Adams et al., 2004). The original scale was created to screen for prescription drug misuse among chronic pain patients undergoing opioid therapy, and the shortened scale was created for use among a military veteran population. Scale ranges from 1-5 with higher scores indicating a worse outcome.|Baseline and 1 month||||score on a scale||Standard Deviation|Mean
2536551|NCT03165175|Primary|Current Opioid Misuse Measure (COMM)|Mean COMM scale score as an indicator of risk for opioid prescription drug misuse. It measures 17 misuse behaviors over the past 30 days for those currently taking medications. Scores can range from 0-4 with higher scores indicating a worse outcome.|Baseline and 1 month||||score on a scale||Standard Deviation|Mean
2536552|NCT03165110|Secondary|Average Change in Total Daily Insulin Dose From Study Start to End of Study|A Subjects' self-reported Total Daily Insulin Doses at visit 1 were compared with their self-reported Total Daily Insulin Doses at Visit 2 (end of study).|6 weeks|change in insulin dose from visit 1 to visit 2.|||IU||Standard Error|Least Squares Mean
2536553|NCT03165110|Secondary|Average Change in Subject BMI From Study Start to End of Study|Subject BMI results at visit 1 were compared with BMI results at Visit 2 (end of study).|6 weeks|46 people with insulin-dependent diabetes|||Kg/m^2||Standard Error|Least Squares Mean
2536554|NCT03165110|Secondary|Average Change in Subject Body Weight From Study Start to End of Study|The average change in subject body weight from study start (Visit 1) to end of study (Visit 2).|6 weeks|46 people with insulin-dependent diabetes|||lbs||Standard Deviation|Least Squares Mean
2536555|NCT03165110|Secondary|Change in Fructosamine (µmol/L) From Study Start to End of Study|Laboratory reports were used to compare fructosamine results from subjects at visit 1 with frustosamine results at Visit 2 (end of study).|6 Weeks|46 people with insulin-dependent diabetes|||µmol/L||Full Range|Least Squares Mean
2536556|NCT03165110|Secondary|Change in HbA1c% From Study Start to End of Study|Laboratory reports were used to compare HbA1c results from subjects at visit 1 with HbA1c results at Visit 2 (end of study). The average change of HbA1c for all subjects at Visit 1 were compared to the average change of HbA1c for all subjects at Visit 2. Lower scores are better outcomes.|6 weeks|46 people with insulin-dependent diabetes (1 subject was not included in this analysis due to dropping out of study before Visit 2)|||change in HbA1c%||Full Range|Least Squares Mean
2536557|NCT03165110|Primary|Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Success in Interpreting the Expanded Graph and My Readings View in the Onyx App System|Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the subjects ability to interpret the Expanded Graph and My Readings views in Onyx the App System. Subjects could respond '1Strongly Agree' or '2Agree' or '3Neither Agree nor Disagree' or '4Disagree' or '5Strongly Disagree' or '6No Opinion'.|6 weeks|46 people with insulin-dependent diabetes|||Participants|||Count of Participants
2536558|NCT03165110|Primary|Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Success at Accessing the Expanded Graph and My Readings View in the Onyx App System|Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the subjects ability to access the Expanded Graph and My Readings views in Onyx App System. Subjects could respond '1Strongly Agree' or '2Agree' or '3Neither Agree nor Disagree' or '4Disagree' or '5Strongly Disagree' or '6No Opinion'.|6 weeks|46 people with insulin-dependent diabetes|||Participants|||Count of Participants
2536559|NCT03165110|Primary|Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Success in Accessing and Using Smart Reminders Feature in the Onyx App System|"Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on accessing and using the Smart Reminders feature in the Onyx App System. Subjects could respond '1Strongly Agree' or '2Agree' or '3Neither Agree nor Disagree' or '4Disagree' or '5Strongly Disagree' or '6No Opinion'.Recognize and use Smart Reminders"|6 weeks|46 people with insulin-dependent diabetes|||Participants|||Count of Participants
2536596|NCT03162614|Secondary|Number of Subjects With Any Solicited Local Symptoms|Solicited local symptoms assessed are pain, redness and swelling. Any occurrence of symptom regardless of intensity grade. Any Redness or any Swelling symptom = any symptom greater than (>) 0 millimeter (mm).|Within the 7-day period (Days 1-7) after dose 1, dose 2 (except for Adu1Fx Group) and dose 3.|The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine|||Participants|||Count of Participants
2536560|NCT03165110|Primary|Percent of Responses From Persons With Diabetes That 'Strongly Agree' or 'Agree' or 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Success With Syncing the Reading on the Onyx Glucose Meter and App.|Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the success of syncing the blood glucose value on the meter with the App for the Onyx Glucose Meter and App System. Subjects could respond '1Strongly Agree' or '2Agree' or '3Neither Agree nor Disagree' or '4Disagree' or '5Strongly Disagree' or '6No Opinion'.|6 weeks|46 people with insulin-dependent diabetes|||percentage of participants|||Number
2536561|NCT03165045|Secondary|Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2|To assess the willingness to continue treatment with Spiolto® Respimat® at visit 2 patients were asked a yes/no question if they would continue the treatment.|6 weeks|Patients with a performed visit 2|||Participants|||Count of Participants
2536562|NCT03165045|Secondary|Patient Satisfaction With Spiolto® Respimat® at Visit 2|"A patient satisfaction survey was performed at visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied.~The 7-item satisfaction scale is a self-designed Boehringer-Ingelheim scale, without a public source or validation status."|6 weeks|All screened patients with informed consent, at least one documented administration of Spiolto® Respimat® and available CCQ scores at visit 1 and visit 2, were defined as full analysis set (FAS).|||Participants|||Count of Participants
2536563|NCT03165045|Secondary|General Condition of the Patient|"General condition of the patient, evaluated by the physician (Physician's global Evaluation score) at visit 1 and visit 2.~The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent). The modified Medical Research Council (mMRC) scale was used to assess the breathlessness state of the patient before the treatment."|Baseline visit (Visit 1) at the start of the study and final visit at the end of the study (visit 2), approximately 6 weeks after visit 1|All screened patients with informed consent, at least one documented administration of Spiolto® Respimat® and available CCQ scores at visit 1 and visit 2, were defined as full analysis set (FAS).|||Participants|||Count of Participants
2536564|NCT03165045|Secondary|Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2|"Absolute changes in total CCQ score and CCQ-4 score from baseline visit at the start of the study to final visit at the end of study.~The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. A higher CCQ score is indicative of worse status. A change of 0.4 points is was considered to be the minimal clinically important difference (MCID) for both CCQ score and CCQ-4."|Final visit at the end of the study, approximately 6 weeks after start of study|All screened patients with informed consent, at least one documented administration of Spiolto® Respimat® and available CCQ scores at visit 1 and visit 2, were defined as full analysis set (FAS).|||Percentage of patients (%)||Standard Deviation|Mean
2536565|NCT03165045|Primary|Therapeutic Success|"The primary endpoint of the study was therapeutic success at visit 2.~The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6 at baseline and at the end of observation after approximately 6 weeks. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. A higher CCQ score is indicative of worse status. A decrease of 0.4 points is considered to be the minimal clinically important difference (MCID) for both CCQ score and CCQ-4."|Final visit at the end of the study, approximately 6 weeks after start of study|All screened patients with informed consent, at least one documented administration of Spiolto® Respimat® and available CCQ scores at visit 1 and visit 2, were defined as full analysis set (FAS).|||Participants|||Count of Participants
2536566|NCT03164629|Primary|Time for Prostatic Artery Catheterization|"For the cases using Emboguide this will be measured as the time from which the Emboguide is displayed on the live fluoroscopy to the time of prostatic artery catheterization. Emboguide display is in addition to the angiogram roadmap display.~For the control cases this will be measured as the time from which the angiogram is displayed on the live fluoroscopy to the time of prostatic artery catheterization."|hour 2|at times unable to catheterize the participants arteries|||seconds||Standard Deviation|Mean
2536567|NCT03163342|Secondary|Mucosal Influenza Antibody Response|To evaluate mucosal influenza antibody responses as measured by IgA ELISA following administration of seasonal influenza vaccine|Day 29 after vaccine||||GMT||95% Confidence Interval|Geometric Mean
2536568|NCT03163342|Secondary|Cellular Immune Response|To evaluate cellular immune responses to influenza as measured by PBMC ELISpot following administration of seasonal influenza vaccine|Day 8 after vaccine||||GMT||95% Confidence Interval|Geometric Mean
2536569|NCT03163342|Secondary|Antibody Response to Divergent Influenza Strains|l) antibody responses to divergent influenza strains as measured by hemagglutination inhibition (HAI) following administration of a seasonal influenza vaccine|Day 29 after vaccine||||GMT||95% Confidence Interval|Geometric Mean
2536570|NCT03163342|Primary|HAI Antibody Immune Response to Matched Influenza Strain H1N1 A/California/04/2009 Strain|To evaluate antibody response against matched influenza strain H1N1 A/California/04/2009 strain as measured by hemagglutination inhibition (HAI) following administration of a seasonal influenza vaccine.|Day 29 after vaccine||||Geometric Mean Titer||95% Confidence Interval|Geometric Mean
2536571|NCT03163134|Secondary|Number of Participants With Postoperative Complications|Determine the rate of any postoperative complications related to Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Meningitis and Respiratory infections in EEA patients who received lumbar drain placement and EEA patients who did not receive lumbar drain placement.|1 year||||Participants|||Count of Participants
2536572|NCT03163134|Primary|Number of Participants With Cerebrospinal Fluid (CSF) Leak|Determine the rate of CSF leak in endoscopic endonasal approach (EEA) patients who received lumbar drain placement and EEA patients who did not receive lumbar drain placement.|1month||||Participants|||Count of Participants
2536573|NCT03163017|Secondary|Number of Participants With Syndesmotic Malreduction as Assessed by a Single Postoperative Bilateral CT Scan|Malreduction will be determined by comparing uninjured ankle to the injured ankle|1 day after 3D Fluoroscopy||||Participants|||Count of Participants
2536574|NCT03163017|Secondary|Function as Assessed by the PROMIS Score|Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures|6 months after 3D Fluoroscopy|Data was not collected for this outcome measure.||||||
2536584|NCT03163017|Secondary|Number of Participants for Which the Surgeon Changed Reduction of Fibular Fracture Reduction Because of Information Provided by 3D Fluoroscopy|Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers (2D Fluoroscopy). After the attending surgeon is satisfied with the reduction quality, 3D fluoroscopy will be used to generate additional images to assess fibular fracture reductions.|Immediately at the time of 3D Fluoroscopy||||Participants|||Count of Participants
2536585|NCT03163017|Primary|Number of Participants for Which the Surgeon Changed Reduction of Syndesmotic Reduction Because of Information Provided by 3D Fluoroscopy|Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers (2D Fluoroscopy). After the attending surgeon is satisfied with the reduction quality, 3D fluoroscopy will be used to generate additional images to assess syndesmotic reductions.|Immediately at the time of 3D Fluoroscopy||||Participants|||Count of Participants
2536586|NCT03162614|Secondary|Number of Subjects With Any, Fatal or Related SAE, After Challenge|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From day of challenge (Day 287) to the end of the challenge phase (Day 315)|The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine|||Participants|||Count of Participants
2536587|NCT03162614|Secondary|Number of Subjects With Abnormal Laboratory Values Gradings|Biochemistry (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST] and creatinine) and hematological (hemoglobin, platelets, White Blood Cells [WBC] decrease and WBC increase) laboratory values were presented according to toxicity grading scales (Grade 0 [GR0], Grade 1 [GR1], Grade 2 [GR2] Grade 3 [GR3]) and tabulated by group. Grading scale is taken from the [FDA guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (September 2007)].|At Visit 1 Screening (Day -89 to Day 1), Day 36, Day 59, Day 204, Day 227, between Day 292 & Day 313, and Day 315 for each vaccinated subject.For Infectivity Control subjects at Visit 1b Screening (Day 231 to Day 287),between Day 292 & Day 313,and Day 315|The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine|||Participants|||Count of Participants
2536588|NCT03162614|Secondary|Number of Subjects With Meningitis|Meningitis is to be reported as an adverse event of specific interest and tabulated per study group.|From Day 1 up to study conclusion (Day 377)|The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine|||Participants|||Count of Participants
2536589|NCT03162614|Secondary|Number of Subjects With Potential Immune Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.|From Day 1 up to study conclusion (Day 377)|The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine|||Participants|||Count of Participants
2536590|NCT03162614|Secondary|Number of Subjects With Any AE and SAE Leading to Withdrawal From Further Vaccination|An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 1 up to study conclusion (Day 377)|The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine|||Participants|||Count of Participants
2536591|NCT03162614|Secondary|Number of Subjects With Any, Fatal or Related SAEs During the Whole Study Period|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 1 up to study conclusion (Day 377)|The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine|||Participants|||Count of Participants
2536592|NCT03162614|Secondary|Number of Subjects With Any, Fatal or Related Serious Adverse Events (SAEs) After Each Vaccination|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Within the 30-day period (Days 1-30) after any vaccination (across doses)|The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine|||Participants|||Count of Participants
2536593|NCT03162614|Secondary|Number of Subjects With Any Unsolicited AEs After Challenge|An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product.|Within the 30-day (Days 1-30) period post-challenge|The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine|||Participants|||Count of Participants
2536594|NCT03162614|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) After Any Vaccination|An unsolicited adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited adverse event is any event reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 30-day period (Days 1-30), after any vaccination (across doses)|The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine|||Participants|||Count of Participants
2536595|NCT03162614|Secondary|Number of Subjects With Any Solicited General Symptoms|Solicited general symptoms assessed are fatigue, gastrointestinal symptoms, headache and fever. Any occurrence of symptom regardless of intensity grade. Fever was defined as temperature equal or greater than (≥) 37.5 degrees Celsius (°C) for oral route, axillary or tympanic route or 38.0°C for rectal route.|Within the 7-day period (Days 1-7) after dose 1, dose 2 (except for Adu1Fx Group) and dose 3.|The analysis was performed on Intent-To-Treat Set, which included all subjects who received at least one dose of study vaccine|||Participants|||Count of Participants
2536597|NCT03162614|Secondary|Anti-Hepatitis B (Anti-HBs) Immunoglobulin G (IgG) Antibody Concentrations|Anti-HBs IgG antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milli-International Unit per milliliter (mIU/ml). The cut-off for the assay was 6.2 mIU/mL.|At Day 1, Day 59, Day 197, Day 227, Day 287, Day 315, and Day 377 for subjects from AduFx, 2PedFx, PedFx, and Adu2Fx Groups. At Day 1, Day 197, Day 227, Day 287, Day 315, and Day 377 for subjects from Adu1Fx Group|Analysis was performed on subjects fulfilling eligibility criteria, who received study vaccination according to protocol procedures (therefore, not on subjects from the Control Group), did not report any medical condition influencing the efficacy response, had data concerning immunogenicity outcome measures, and underwent P. falciparum challenge.|||mIU/mL||95% Confidence Interval|Geometric Mean
2536598|NCT03162614|Secondary|Anti-Circumsporozoite (Anti-CS) Repeat Region Antibody Concentrations|Anti-CS antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in Enzyme-linked immunosorbent assay Unit per milliliter (EU/mL). The cut-off for the assay was 1.9 EU/mL. The GMC calculations were performed by taking the anti-log of the mean of the log transformations (base 10). Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off (=1.0) for the purpose of GMC calculation.|At Day 1, Day 59, Day 197, Day 227, Day 287, Day 315, and Day 377 for subjects from AduFx, 2PedFx, PedFx, and Adu2Fx Groups. At Day 1, Day 197, Day 227, Day 287, Day 315, and Day 377 for subjects from Adu1Fx Group|Analysis was performed on subjects fulfilling eligibility criteria, who received study vaccination according to protocol procedures (therefore, not on subjects from the Control Group), did not report any medical condition influencing the efficacy response, had data concerning immunogenicity outcome measures, and underwent P. falciparum challenge.|||EU/mL||95% Confidence Interval|Geometric Mean
2536599|NCT03162614|Secondary|Time to Onset of P. Falciparum Parasitemia After Sporozoite Challenge for Each Vaccination Schedule|For the analyses of time to onset of parasitemia, time at risk started on first day of challenge. Time at risk was censored on Day 315 (28 days post challenge), drop-out date, start date of antimalarial treatment or date meeting an endpoint, whichever occurs first.|Following sporozoite challenge starting 3 months after the last vaccine dose (at Day 287) for up to 28 days post-challenge (at Day 315).|Analysis was performed on Per-Protocol Set, which included all subjects fulfilling eligibility criteria who received vaccinations according to protocol procedures, did not report any underlying medical condition influencing the efficacy response, had available data concerning immunogenicity outcome measures, and underwent P. falciparum challenge.|||Days||Standard Deviation|Mean
2536600|NCT03162614|Primary|Number of Subjects With at Least One Occurrence of Plasmodium Falciparum (P. Falciparum) Parasitemia for Each Vaccination Schedule Versus Infectivity Controls|Occurrence of P. falciparum parasitemia (defined by a positive blood slide) following sporozoite challenge. Post-challenge, parasitemia was determined by microscopy of Giemsa-stained thick blood films (smear). Microscopy was performed on thick smears using a validated standard operation procedure. For the analysis of proportion affected (relative risk), all subjects included in the analysis were considered at risk of infection and no censoring or elimination was applied for subjects not completing the entire protocol defined post challenge follow-up (Day 315 - 28 days post challenge).|Following sporozoite challenge starting 3 months after the last vaccine dose (Day 287) for up to 28 days post-challenge (Day 315).|Analysis was performed on Per-Protocol Set, which included all subjects fulfilling eligibility criteria who received vaccinations according to protocol procedures, did not report any underlying medical condition influencing the efficacy response, had available data concerning immunogenicity outcome measures, and underwent P. falciparum challenge.|||Participants|||Count of Participants
2536601|NCT03162458|Secondary|Percentage of Patients With Complications of Illness, Including Those Requiring Antibiotic Administration or Hospitalization) for 14 Days of Observation||From the time of randomization up to 14 days|Intention to treat|||percentage of participants|||Number
2536602|NCT03162458|Secondary|Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data)|based on patient diary data|on Days 1-5 of treatment|Intention to treat set|||Number of intakes||Standard Deviation|Mean
2536603|NCT03162458|Secondary|"Severity of the Disease Within 5 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) on Days 1, 3, 6 (According to the Results of Pediatrician's Examination)"|"The TSS was based on the severity of each of acute upper respiratory tract infection (URTI) symptom.~The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough).~The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).~Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by the study researchers (pediatricians) on the case record form on Days 1, 3, 6."|on Days 1, 3, 6|Intention to treat set|||AUC score*day||Standard Deviation|Mean
2536604|NCT03162458|Secondary|Total Symptom Score on Days 3 and 6 of Observation Based on the Results of Pediatrician's Examination|"The Total Symptom Score (TSS) was based on the severity of each of acute upper respiratory tract infection (URTI) symptom.~The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough).~The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).~Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by the study researchers (pediatricians) on the case record form on Days 1, 3, 6."|On Days 1, 3, 6 of the treatment|Intention to treat set|||Score||Standard Deviation|Mean
2536605|NCT03162458|Secondary|Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation|based on patient diary data|On Days 2-5 of observation|Intention to treat set|||percentage of participants|||Number
2536606|NCT03162458|Secondary|Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data)|based on patient diary data|On Days 2-5 of the treatment|Intention to treat set|||°C||Standard Deviation|Mean
2536607|NCT03162458|Secondary|Average Duration of Fever (i.e. Body Temperature >37.3°С)|based on patient diary data|From the time of randomization until the time of normal body temperature, assessed up to 14 days|Intention to treat set|||hours||Standard Deviation|Mean
2536609|NCT03162458|Primary|"Severity of the Disease Within 5 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS) at 1-5 Days (According to the Diary of the Patient)."|"The TSS was based on the severity of each of acute upper respiratory tract infection (URTI) symptom.~The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough).~The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).~Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5."|On days 1-5 of observation|Intention to treat set|||AUC score*day||Standard Deviation|Mean
2536610|NCT03162458|Primary|Average Illness Duration (the Interval Between the Start of the Trial Treatment and the Time When Recovery/Improvement - Based on Patient Diary Data)|based on patient diary data|From the time of randomization until the time of recovery/improvement, assessed up to 14 days|Intention to treat set|||hours||Standard Deviation|Mean
2536611|NCT03162328|Secondary|Psychomotor Vigilance Test - Average Speed|To measure trends of vigilance of (2 nights) of home use randomized with active PowerSleep (delivering audio tones) as compared to (2 nights) of sham (delivering no audio tones). This measured the average speed with which participants respond to a visual stimulus. The average speed is 1/RT (also called reciprocal response time or response speed).|4 nights|"2 participants completed the wrong PVT~1 participant did not complete the final overnight~1 participant did not complete the PVT after wake-up 8 data sets were lost as participants did not cross over~1 participant napped in between overnights and the data was no usable"|||1/s||Standard Deviation|Mean
2536612|NCT03162328|Secondary|Psychomotor Vigilance Test - Number of Anticipation and Number of Lapses.|To measure trends of vigilance of (2 nights) of home use randomized with active PowerSleep (delivering audio tones) as compared to (2 nights) of sham (delivering no audio tones). Anticipations are the increase in errors of commission (responses without a stimulus) response time <100ms. Lapses (errors of omission) are measured or usually defined as reaction Times ≥ 500 ms.|4 nights|"2 participants completed the wrong PVT~1 participant did not complete the final overnight~1 participant did not complete the PVT after wake-up 8 data sets were lost as participants did not cross over~1 participant napped in between overnights and the data was no usable"|||count of events||Standard Deviation|Mean
2536613|NCT03162328|Secondary|Psychomotor Vigilance Test - Reaction Times|"To measure trends of vigilance of (2 nights) of home use randomized with active PowerSleep (delivering audio tones) as compared to (2 nights) of sham (delivering no audio tones). This measured how quickly participants reacted to visual stimulus.~Reaction time is the latency at which the participant reacts to a visual stimulus > 100 ms."|4 nights|"2 participants completed the wrong PVT~1 participant did not complete the final overnight~1 participant did not complete the PVT after wake-up 8 data sets were lost as participants did not cross over~1 participant napped in between overnights and the data was no usable"|||milliseconds||Standard Deviation|Mean
2536614|NCT03162328|Secondary|Average of Subjective Sleepiness Scale- Samn Perelli|"Average subjective sleepiness between PowerSleep Sham as compared to PowerSleep Stim on the Samn Perelli questionnaire 1 - fully alert, wide awake, extremely peppy and 7 - completely exhausted, unable to function effectively, ready to drop~Sleepiness scales were completed each morning following after the 2 nights of the one condition and the 2 nights in the other condition. The averages of the 2 nights (mornings after) are compared to the average of the 2 nights(mornings after) the following week. Therefore the timeframe is 4 nights."|2 days following each intervention, over 9 days|"8 data sets were lost as participants were not crossed over to the other arm of the trial.~1 participant napped between overnights and was excluded from the daytime measures~1 participant did not complete the final overnight"|||score on a scale||Standard Deviation|Mean
2536615|NCT03162328|Secondary|Average Subjective Sleepiness Scale- Karolinska Sleepiness Scale|"Average subjective sleepiness between PowerSleep Sham nights as compared to PowerSleep Stim nights on the Karolinska Sleepiness Scale 1 - very alert, 9 - very sleepy, great effort to keep awake~Sleepiness scales were completed each morning following after the 2 nights of the one condition and the 2 nights in the other condition. The averages of the 2 nights (mornings after) are compared to the averages of the 2 nights (mornings after) the following week. Therefore the timeframe is 4 nights."|2 days following each intervention, over 9 days|"4 data sets were lost in the Sham/Stim condition: 4 - not crossed over 4 data sets were lost in the Stim/Sham condition: 4 - not crossed over~1 participant napped between overnights and was excluded from the daytime measures~1 participant did not complete the final overnight"|||score on a scale||Standard Deviation|Mean
2536616|NCT03162328|Secondary|Average Subjective Sleepiness Scales.|"Average subjective sleepiness scales, as measured by scores on a scale of 0 to 10, PowerSleep Sham over 2 works nights of use as compared to PowerSleep Stim over 2 works nights of use. For these outcomes the 0 was the worst, 10 being the best.~Sleepiness scales were completed each morning following after the 2 nights of the one condition and the 2 nights in the other condition. The values of 2 nights (mornings after) are averaged and compared to the average of the 2 nights the following week. Therefore the timeframe is 4 nights."|2 days following each intervention, over 9 days|"8 data sets were lost in the analysis as participants were randomized but not crossed over to the other arm of the study.~1 data set was lost because the wrong form was administered.~1 participant did not complete the final overnight"|||score on a scale||Standard Deviation|Mean
2536625|NCT03162055|Other Pre-specified|Mean Change From Baseline in Night-Time Symptoms of COPD Instrument (NiSCI) Over 24 Weeks|Change from baseline in the 6-item NiSCI Symptom Severity Score was derived by averaging the responses from a participant on the 6 item-level symptom scores (scored on a 4-point scale from 1 to 4, whereas 1= mild and 4= very severe). The NiSCI collected data about the frequency and severity of night-time symptoms and the impact of COPD symptoms on night-time awakenings in participants with COPD. Participants completed a daily ePRO questionnaire for their COPD symptoms. Baseline is defined as the average of the non-missing values from the ePRO data collected in the last 7 days before the randomization (Day 1).|From Baseline (Day -7) up to 24 weeks|The PP analysis set included the subset of the FAS containing participants with post-randomization data obtained prior to important protocol deviations which may have affected efficacy. Only participants with data available for analysis are presented.|||Units on a scale||Standard Error|Least Squares Mean
2536617|NCT03162328|Secondary|Changes in Cognitive Testing - Verbal Fluency|"To evaluate the relationship between cognitive testing changes and changes in SWA. Verbal fluency is a type of cognitive testing in which participants are required to generate as many words directly related to the instructions as they can. This task has three conditions each arm:letter fluency (F,A,S and B,H,R),category fluency (Animals, Boys names and clothing girls names) and category switching (Fruits and furniture and vegetables and musical instruments). Each trial with each condition lasts for 60 seconds.~Total correct responses are calculated by counting the number of correct words generated for each condition: letter fluency, category fluency and switching~Total repetition errors are calculated by counting any response that is repeated within the 60sec trial for each condition.~Total set-loss errors are any response that violates any of the criterion rules of the condition (for example saying Bill instead of Beth for girls names) for each condition."|4 nights|"5 participants did not have verbal fluency recorded therefore were unable to be scored~1 participant was excluded from the analysis because they did not complete the final night of the study~1 participant was excluded because they had to repeat second work week 8 data sets were lost because they were not crossed over"|||words||Standard Deviation|Mean
2536618|NCT03162328|Secondary|Paired Associates Learning (PAL)|"To measure trends of memory of 2 weeks of home use randomized with active PowerSleep (delivering audio tones) as compared to a two weeks of sham (delivering no audio tones).~Participants answered completed an 80 word pair memory recall in the morning following the overnight in the sleep lab. The results listed below are the mean and standard deviation of the PowerSleep treatment week compared to the Sham treatment week. Learning was completed on the last night in the lab in each arm, with recall in the morning.~PAL Differences (morning - evening responses): Difference between number correct the morning recall and the evening recall~Correct Responses (evening recall): number of correct responses during the evening recall~Correct Responses (morning call): number of correct responses during the morning recall, after the night in the sleep lab."|4 nights|"1 participant was excluded from the analysis because they did not complete the final night of the study 4 data sets were lost in the Sham/Stim condition: 4 - not crossed over 4 data sets were lost in the Stim/Sham condition: 4 - not crossed over~1 participant did not complete the learning in the evening therefore data was unscorable."|||number of words||Standard Deviation|Mean
2536619|NCT03162328|Secondary|Changes in Multiple Sleep Latency Test (MSLT)|To evaluate the relationship between MSLT (sleep latency) and changes in SWA. This evaluated the average length of time it took a participant to fall asleep (in minutes) for each of the 4 naps in each condition, after two nights of sham and two nights of stim.|4 nights|"1 participant was excluded from the analysis because of a nap in between treatment nights~1 participant was excluded from the analysis because they did not complete the final night of the study 4 data sets were lost in the Sham/Stim condition: 4 - not crossed over 4 data sets were lost in the Stim/Sham condition: 4 - not crossed over"|||minutes||Standard Deviation|Mean
2536620|NCT03162328|Primary|Cumulative Amount of Slow Wave Activity Delivered by the Powersleep Device With and Without Stimulation|"It is hypothesized that the use of active PowerSleep over two work nights of use, as compared to the sham device over two works nights of use, will result in a significant increase (≥5%), in mean total slow-wave activity (SWA).The integral of SWA (CSWA) over a sleep session, is directly proportional to the sleep-need dissipation occurring during said sleep session.~In our research, both SWA and CSWA are evaluated as relative values having as reference the average SWA and CSWA over sham sleep sessions. CSWA is the integral of SWA which is why the unit of CSWA is microvolt^2×minute."|4 nights|5 data sets were lost in the Sham/Stim condition: 1 - noisy data, 4 - not crossed over 4 data sets were lost in the Stim/Sham condition: 4 - not crossed over|||microvolts^2×minute||Standard Deviation|Mean
2536621|NCT03162328|Primary|Average Amount of Slow Wave Activity Delivered by the Powersleep Device With and Without Stimulation|It is hypothesized that the use of active PowerSleep over two work nights of use, as compared to the sham device over two work nights of use, will result in a significant increase (≥5%), in mean total slow-wave activity (SWA). Slow wave activity (SWA) corresponds to the EEG power in the 0.5 to 4 Hz band during non-rapid eye movement (NREM) sleep. SWA reflects the number and amplitude of slow-waves and determines the speed with which sleep-need dissipates.|4 nights|5 data sets were lost in the Sham/Stim condition: 1 - noisy data, 4 - not crossed over 4 data sets were lost in the Stim/Sham condition: 4 - not crossed over|||microvolts^2||Standard Deviation|Mean
2536622|NCT03162055|Primary|Mean Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks in FAS Population|To assess the effects of GFF relative to UV on lung function in FAS population as measured by peak change from baseline in FEV1 is defined as the maximum of the FEV1 assessments within the 2 hours post-dosing time windows at each visit minus baseline using spirometry. Baseline is defined as the mean of the non-missing -60 and -30 minute values obtained prior to dosing at randomization (Day 1).|From Baseline (Day 1) up to 24 weeks|The FAS included all randomized participants who received at least 1 inhalation of IP from the GFF or UV inhaler (active or placebo).|||mL||Standard Error|Least Squares Mean
2536623|NCT03162055|Other Pre-specified|Mean Change From Baseline in COPD Assessment Test (CAT) Score Over 24 Weeks|The CAT is used to quantify the impact of COPD symptoms on health status. The CAT has a scoring range of 0-40, and it is calculated as the sum of the responses given for each of the 8 items (scored on a 6-point scale from 0 to 5), with higher scores indicating a higher impact of COPD symptoms on health status. If the response to 1 of the 8 items is missing, the missing item was considered equal to the average of the 7 non-missing items for that participant. If more than 1 item is missing the score was considered missing. Baseline is defined as the latest assessment within 7 days before or at randomization (Day 1).|From Baseline (Day -7 or 1) up to 24 weeks|The PP analysis set included the subset of the FAS containing participants with post-randomization data obtained prior to important protocol deviations which may have affected efficacy. Only participants with data available for analysis are presented.|||Units on a scale||Standard Error|Least Squares Mean
2536624|NCT03162055|Other Pre-specified|Mean Change From Baseline in Daily Rescue (Albuterol/Salbutamol MDI) Use Over 24 Weeks|The number of inhalations of rescue albuterol/salbutamol MDI was recorded in the participant ePRO in the morning and evening. Baseline is defined as the average of the non-missing values from the ePRO data collected in the last 7 days before the randomization (Day 1). a/s = albuterol/salbutamol.|From Baseline (Day -7) up to 24 weeks|The rescue medication user analysis set included all participants in the FAS with average baseline rescue albuterol/salbutamol MDI use of >=1 inhalation/day. Only participants with data available for analysis are presented.|||puffs/day||Standard Error|Least Squares Mean
2536626|NCT03162055|Secondary|Mean Change From Baseline in Early Morning Symptoms of COPD Instrument (EMSCI) Over 24 Weeks|Change from baseline in the 6-item EMSCI Symptom Severity Score was derived by averaging the responses from a participant on the 6 item-level symptom scores (scored on a 4-point scale from 1 to 4, whereas 1= mild and 4= very severe). The EMSCI collected data about the frequency and severity of early morning symptoms and the impact of COPD symptoms on early morning activity in participants with COPD. Participants completed a daily electronic patient-reported outcome (ePRO) questionnaire for their COPD symptoms. Baseline is defined as the average of the non-missing values from the ePRO data collected in the last 7 days before the randomization (Day 1). TI = Time interval.|From Baseline (Day -7) up to 24 weeks|The PP analysis set included the subset of the FAS containing participants with post-randomization data obtained prior to important protocol deviations which may have affected efficacy. Only participants with data available for analysis are presented.|||Units on a scale||Standard Error|Least Squares Mean
2536627|NCT03162055|Secondary|Mean Transition Dyspnea Index (TDI) Focal Score Over 24 Weeks|The baseline dyspnea index (BDI) and TDI consist of 3 individual components: functional impairment, magnitude of task, and magnitude of effort. For the BDI, each of these 3 components were rated in 5 grades from 0 (very severe) to 4 (no impairment), and were summed to form a baseline total score from 0 to 12. For the TDI, changes in dyspnea were rated for each component by 7 grades from -3 (major deterioration) to +3 (major improvement), and were added to form a TDI focal score from -9 to +9. Baseline is defined as the latest BDI assessment within 7 days before or at randomization (Day 1).|From Baseline (Day -7 or 1) up to 24 weeks|The PP analysis set included the subset of the FAS containing participants with post-randomization data obtained prior to important protocol deviations which may have affected efficacy. Only participants with data available for analysis are presented.|||Units on a scale||Standard Error|Least Squares Mean
2536628|NCT03162055|Secondary|Mean Peak Change From Baseline in Inspiratory Capacity (IC) Within 2 Hours Post-dosing Over 24 Weeks|Peak change from baseline in IC is defined as the maximum of the IC assessments within the 2 hours post-dosing time windows at each visit minus baseline. Baseline is defined as the average of available evaluable -60 and -30 minute pre-dose assessments conducted at randomization (Day 1).|From Baseline (Day 1) up to 24 weeks|The PP analysis set included the subset of the FAS containing participants with post-randomization data obtained prior to important protocol deviations which may have affected efficacy. Only participants with data available for analysis are presented.|||mL||Standard Error|Least Squares Mean
2536629|NCT03162055|Secondary|Percentage of Participants With Increase of FEV1 of >=100 mL From Baseline at 5 Minutes Post-dosing on Day 1|The percentage of participants with an increase in FEV1 of >=100 mL from baseline at 5 minutes post-dosing on Day 1 was determined to assess the early onset of action. Baseline is defined as the average of available evaluable -60 and -30 minute pre-dose assessments conducted at randomization (Day 1). Only data assigned to the 5 minute window was used to determine response. Participants with missing data were considered non-responders for the analysis.|5 minutes post-dose on Day 1|The FAS analysis set included all randomized participants who received at least 1 inhalation of IP from the GFF or UV inhaler (active or placebo).|||Percentage of participants|||Number
2536630|NCT03162055|Primary|Mean Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks in PP Analysis Set Population|To assess the effects of GFF relative to UV on lung function in PP analysis set population as measured by peak change from baseline in FEV1 is defined as the maximum of the FEV1 assessments within the 2 hours post-dosing time windows at each visit minus baseline using spirometry. Baseline is defined as the mean of the non-missing -60 and -30 minute values obtained prior to dosing at randomization (Day 1).|From Baseline (Day 1) up to 24 weeks|The PP analysis set included the subset of the FAS containing participants with post-randomization data obtained prior to important protocol deviations which may have affected efficacy. Only participants with data available for analysis are presented.|||mL||Standard Error|Least Squares Mean
2536631|NCT03162055|Primary|Mean Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) Over 24 Weeks|To assess the effects of GFF relative to UV on lung function as measured by change from baseline in morning pre-dose trough FEV1 is defined as the average of the -60 and -30 minute pre-dose values at each visit minus baseline using spirometry. Baseline is defined as the mean of the non-missing -60 and -30 minute values obtained prior to dosing at randomization (Day 1). BR a/s = bronchodilator responsiveness to albuterol/salbutamol.|From Baseline (Day 1) up to 24 weeks|The PP analysis set included the subset of the FAS containing participants with post-randomization data obtained prior to important protocol deviations which may have affected efficacy. Only participants with data available for analysis are presented.|||milliliter (mL)||Standard Error|Least Squares Mean
2536632|NCT03161938|Secondary|Number of Patients With Wound Infections Within 30 Days|Any wound infections/complications|30 days||||Participants|||Count of Participants
2536633|NCT03161938|Secondary|Number of Patients Readmitted to Hospital Within 30 Days|Any readmission within 30 days|30 days||||Participants|||Count of Participants
2536634|NCT03161938|Secondary|Number of Patients With Feelings of Anxiety, Unrest and/or Sadness|Self-reported feelings of anxiety, unrest, sadness (days 0-4). Questionnaire|postoperative day 0 to 4, once a day|Missing data from questionnaires, missing at random|||Participants|||Count of Participants
2536635|NCT03161938|Secondary|Number of Patients With Sleep Problems|Self-reported quality of sleep (days 0-4). Questionnaire. Results dichotomized to sleep problems (trouble falling asleep, frequent awakenings, no sleep) or no sleep problems.|4 days|Missing data from questionnaires, missing at random, not filled out or not sent back|||Participants|||Count of Participants
2536636|NCT03161938|Secondary|Number of Patients With Post Operative Nausea and Vomiting (PONV) Postoperative Days 0 to 4|Patients reporting PONV and/or receiving antiemetic medication on postoperative days 0 to 4|postoperative day 0 to 4, once a day|Missing data day 4 due to discharge from hospital|||Participants|||Count of Participants
2536637|NCT03161938|Secondary|Self Reported Postoperative Pain|"Self-reported pain on a Numeric rating scale (NRS), NRS 0-10, 0 = no pain, 10= worst pain imaginable.~Reported once daily, postoperative days 0 to 4"|postoperative day 0 to 4, once a day|Missing data, missing at random|||score on a scale||Standard Deviation|Mean
2536638|NCT03161938|Secondary|Complications|Patients with complications requiring treatment the first 24 hours (PACU and ward)|24 hours||||Participants|||Count of Participants
2545585|NCT02940327|Primary|CD14/41|Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.|24 hours after ECMO decannulation||||percentage change||Standard Deviation|Mean
2536643|NCT03161405|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906||TAK-906 maleate 25mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 maleate-dose; Itraconazole 200 mg + TAK-906 maleate 25mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 maleate-dose|The PK analysis set included all participants from the safety set who had at least 1 measurable post-dose TAK-906 plasma concentration. PK analysis set where Day 1 and 4 assessments were available.|||h*ng/mL||Standard Deviation|Geometric Mean
2536644|NCT03161405|Primary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906||TAK-906 maleate 25mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 maleate-dose; Itraconazole 200 mg + TAK-906 maleate 25mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 maleate-dose|The PK analysis set included all participants from the safety set who had at least 1 measurable post-dose TAK-906 plasma concentration.|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Geometric Mean
2536645|NCT03161405|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-906||TAK-906 maleate 25mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 maleate-dose; Itraconazole 200 mg + TAK-906 maleate 25mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 maleate-dose|The pharmacokinetic (PK) analysis set included all participants from the safety set who had at least 1 measurable post-dose TAK-906 plasma concentration.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2536646|NCT03161327|Primary|Positive Predictive Value of Digital ABI in Diagnosing PAD|To evaluate the Positive predictive value of digital ABI in diagnosing PAD using color Doppler ultrasound and 'gold standard' angiography as reference.|3 months|Positive Predictive Value (PPV)|||Participants|||Count of Participants
2536647|NCT03160716|Secondary|Subject Satisfaction|To assess subject satisfaction with the treatment using the FACE-Q. Score range 1-100. The higher total score indicate greater subject satisfaction.|8 weeks||||score on a scale||Standard Deviation|Mean
2536648|NCT03160716|Secondary|Number of Participants That Responded to Treatment|To assess effectiveness using the 4-point Midface Volume Scale. Responder defined as at least a one point improvement from the baseline score at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16).|16 weeks||||Participants|||Count of Participants
2536649|NCT03160716|Secondary|Number of Participants With Aesthetic Improvement|"To assess effectiveness using the Global Aesthetic Improvement Scale (GAIS). Responders defined as Improved or better on the GAIS as assessed by the investigator and participant at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16)."|16 weeks||||Participants|||Count of Participants
2536650|NCT03160716|Primary|Number of Participants With Treatment-Emergent Adverse Events [Safety]|To assess the adverse events (incidence, intensity, and duration) of Restylane® Lyft with Lidocaine in conjunction with the use of a cannula.|16 weeks||||Participants|||Count of Participants
2536651|NCT03160703|Primary|Overall Modified Lobene Stain Index (MLSI) Mean Score at Week 4|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of the allocated study dentifrice, after 4 weeks twice daily use. The intensity of stain was scored separately for the gingival and body areas of each assessable tooth on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored separately for the gingival and body areas of each assessable tooth on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Overall MLSI was calculated by multiplying scores of intensity and area, and was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Baseline and Week 4|The Intent-To-Treat (ITT) population (N=219) included all participants who were randomized, received at least 1 dose of investigational product, and had at least 1 post-baseline efficacy evaluation and were reported by randomized treatment.|||Score on a scale||Standard Deviation|Mean
2536652|NCT03160170|Secondary|Rate of Clogging|Average number of times the suction tip of the device had to be unclogged|1.5 hours||||tip clogs||Standard Deviation|Mean
2536653|NCT03160170|Secondary|Time of Exposure|Length of operation in minutes|1.5 hours||||minutes||Standard Deviation|Mean
2536654|NCT03160170|Primary|Estimated Blood Loss|Amount of blood loss from incision time to screw placement|1.5 hours||||ml||Standard Deviation|Mean
2536655|NCT03160027|Secondary|Change in Geriatric Depression Scale (GDS) - Short Form in the Caregivers|"The GDS-short form is a 15-item yes/no scale that measures depressive symptoms in older individuals. Scores range from 0-15. Higher scores reflect the presence of more depressive symptoms. A score of 0-5 is normal; a score > 5 suggests depression; a score ≥ 10 is strong indicator of depression.~This outcome is a change score: Baseline GDS score - Week 12 GDS score. In participants randomized Delayed PBM treatment who opt to undergo PBM treatments after 12 weeks of Usual Care, Week 12 GDS score - Week 24 GDS score. A positive (or larger) change score = decrease in depressive symptoms in caregivers. A negative (or smaller) change score = increase in depressive symptoms in caregivers."|change from baseline to 12 weeks||||units on the Geriatric Depression Scale||Standard Deviation|Mean
2536656|NCT03160027|Secondary|Change in Positive Aspects of Caregiving Scale|"The Positive Aspects of Caregiving Scale is a standard measure that asks caregivers to rate their agreement/disagreement with 11 statements about positive aspects of caregiving on a 5-point likert scale (disagree a lot ... agree a lot). Scores can range from 11 (few positive aspects of providing care for someone with dementia) to 55 (many positive aspects of providing care for someone with dementia).~This outcome is a change score: Week 12 score - baseline score. A larger (or positive) change score = increase in positive aspects of caregiving. A negative (or smaller) change score = decrease in positive aspects of caregiving."|change from baseline to 12 weeks||||units on Positive Aspects of Caregiving||Standard Deviation|Mean
2536667|NCT03159624|Primary|Mean Change in Post-operative Remucosalization at the Donor Site|Mean change as measured by Visual Analogue Scale (VAS) scores from 3 independent reviewers from endoscopy videos collected at 2, 6, and 12 weeks. The Visual Analogue Scale for mean change in post-operative remucosalization is a Likert scale ranging from 0% (no remucosalization) to 100% (complete remucosalization), with higher scores representing better healing.|2 weeks, 6 weeks, 12 weeks||||percentage of remucosalization||95% Confidence Interval|Least Squares Mean
2536657|NCT03160027|Secondary|Change in Neuropsychiatric Inventory (NPI)|"The NPI assesses the frequency and severity of 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and appetite/eating). It is a questionnaire completed by the caregiver about the individual with dementia. The total NPI score ranges from 0 to 144. A higher the total NPI score signifies more numerous, frequent, and/or more severe dementia-related behaviors.~This outcome is a change score: Baseline NPI score - Week 12 NPI score. (or Week 12 - Week 24 for Delayed PBM participants who opted to undergo PBM treatments) A positive (or larger) change score = decrease in the number and/or severity of dementia-related behaviors. A negative (or smaller) change score = increase in the number and/or severity of dementia-related behaviors."|change from baseline to 12 weeks||||units on CBI scale||Standard Deviation|Mean
2536658|NCT03160027|Secondary|Change in Caregiver Burden Inventory (CBI).|The CBI is a standard measure that includes 24 items and 5 domains. Caregivers are asked to rate how often each statement describes their feelings (never, rarely, sometimes, quite frequently, nearly always). The total score may range from 0 to 96 with higher scores reflecting greater feelings of burden. This outcome is a change score: Baseline CBI score - Week 12 CBI score. A positive (or larger) change score = decrease in caregiver burden. A negative (or smaller) chance score = increase in caregiver burden.|change from baseline to 12 weeks||||units on the CBI scale||Standard Deviation|Mean
2536659|NCT03160027|Secondary|Change in QOL-AD From the Caregiver's Perspective About the Individual With Dementia|This outcome is a change in the quality of life of the individual with dementia from the caregiver's perspective. Scores range from 52 (best possible perceived quality of life) to 0 (worse possible perceived quality of life). A positive or larger change score = decreased quality of life. A negative or smaller change score = improved quality of life.|change from baseline to 12 weeks||||units on QOL-AD score||Standard Deviation|Mean
2536660|NCT03160027|Primary|Change in Quality of Life Scale in Alzheimer's Disease (QOL-AD)|"The QOL-AD is a standard quality of life measure that asks parallel questions of affected individuals and their caregivers. Current quality of life is rated as poor (1 point), fair (2 points), good (3 points) or excellent (4 points) in 13 areas: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, ability to do things for fun, money, and life as a whole. Score range from 0 (worse quality of life) to 52 (best quality of life)~This outcome is a change score, derived by subtracting Baseline from Week 12 scores (or Week 12 - Week 24) for Delayed PBM participants who chose to undergo 12 weeks of PBM after 12 weeks of Usual Care). A higher change score = decline in perceived quality of life. A lower or negative change score = improved perceived quality of life."|change from baseline to 12 weeks||||units on QOL-AD score||Standard Deviation|Mean
2536661|NCT03160027|Primary|Change in Arterial Spin Labeled (ASL) Perfusion MRI Measure|This outcome consists of measures of blood flow to the brain at baseline and at Week 12. Total perfusion values were derived by averaging across the superior frontal, superior parietal, and supramarginal regions of interest (ROI), based on the location of the transcranial LED clusters. The perfusion values were normalized to the precentral gyrus (i.e., motor cortex) perfusion .|change from baseline to 12 weeks||||ratio||Standard Error|Mean
2536662|NCT03160027|Primary|Change in Default Mode Network (DMN) Functional Connectivity|"The DMN is a network of interacting brain regions known to have activity highly correlated with each other and distinct from other networks in the brain. This outcome consists of the strength of the connection between the posterior cingulate cortex (PCC), a hub of the DMN, and the left (L) and right (R) lateral parietal cortex (LP) at baseline and at Week 12. Studies in patients with Alzheimer's disease (AD) suggest there is diminished connectivity between nodes of the DMN in AD. Therefore increased connectivity between nodes of the DMN from baseline to Week 12 (or higher T-scores of the connection) indicate better outcomes. The measure type of number for this assessment is the T-score that was calculated for each group."|change from baseline to 12 weeks||||T-score|||Number
2536663|NCT03160027|Primary|Change in Clock-drawing Test|"The clock-drawing test is used for screening for cognitive impairment and dementia and as a measure of spatial dysfunction and neglect. The score ranges from 0 (none correct) to 5 (all correct). A score greater than or equal to 4 is considered normal The outcome is a change score: Baseline - Week 12 score. Or Week 12 - Week 24 for Delayed PBM participants who opted to undergo 12 weeks of PBM treatments after 12 weeks of Usual Care. A negative change score = improvement; a positive change score = decline."|change from baseline to 12 weeks||||units on clock-drawing test score||Standard Deviation|Mean
2536664|NCT03160027|Primary|Change in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog)|"The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) test is one of the most frequently used tests to measure cognition in research studies and clinical trials for new drugs and other interventions. It consists of 11 tasks measuring the disturbances of memory, language, praxis (e.g., ability to conceptualize, plan, and execute the complex sequences of motor actions), attention and other cognitive abilities which are often referred to as the core symptoms of AD. The ADAS-cog score is based on the number of errors made in each item. Total score ranges from 0 to 70. A score of 70 represents the most severe impairment. A score of 0 represents the least impairment.~This outcome is a change score, derived by subtracting Baseline ADAS-cog score from Week 12 ADAS-cog score."|change from baseline to 12 weeks||||units on the ADAS-cog scale||Standard Deviation|Mean
2536665|NCT03159624|Primary|Mean Change in Post-operative Edema at the Donor Site|Mean change as measured by Visual Analogue Scale (VAS) scores from 3 independent reviewers from endoscopy videos collected at 2, 6, and 12 weeks. The Visual Analogue Scale for mean change in post-operative edema is a Likert scale ranging from 0 (no edema) to 10 (severe edema), with lower scores representing better healing.|2 weeks, 6 weeks, 12 weeks||||score on a scale||95% Confidence Interval|Least Squares Mean
2536666|NCT03159624|Primary|Mean Change in Post-operative Locoregional Crusting at Donor Site|Mean change as measured by Visual Analogue Scale (VAS) scores from 3 independent reviewers from endoscopy videos collected at 2, 6, and 12 weeks. The Visual Analogue Scale for mean change in post-operative crusting is a Likert scale ranging from 0 (no crusting) to 10 (complete crusting), with lower scores representing better healing.|2 weeks, 6 weeks, 12 weeks||||score on a scale||95% Confidence Interval|Least Squares Mean
2536683|NCT03159299|Secondary|Change in Physical Activity From Baseline|Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer.|3 months|||||||
2536668|NCT03159611|Secondary|Clinical Global Impression Scale - Efficacy Index (CGI-EI) Score by the End of the Treatment Course.|The Clinical Global Impressions - Efficacy Index (CGI-EI) scale provide an evaluation of the treatment response. CGI-EI takes account of both therapeutic efficacy and treatment-related adverse events and ranges from 0 (marked improvement and no side-effects) and 4 (unchanged or worse and side-effects outweigh the therapeutic effects).|in 12 weeks of the treatment|Per Protocol set|||score on a scale||Standard Deviation|Mean
2536669|NCT03159611|Secondary|Percentage of Patients With Normal Psychomotor Development (CATS/CLAMS + Gross Motor Developmental Quotients Score ≥ 75) by the End of the Treatment Course Compared to Baseline (Time Frame: 0 Weeks, 4 Weeks, 8 Weeks, 12 Weeks)|The Clinical Adaptive Test/Clinical Linguistic and Auditory Milestone Scale (CAT/CLAMS) Consists of Three batteries: Clinical adaptive test (CAT), clinical linguistic and auditory milestone scale (CLAMS), and Gross motor (GM). CAT is the visual-motor problem-solving battery. The score on the CAT is based on the child's performance with the administered items. CLAMS is the language battery of the test. The score on the CLAMS is based on the parent's report of language skill attainment. GM evaluates motor skills. The score on the GM is based on the direct observation of a child and examination by the neurologist. The scores from the CAT/CLAMS+GM are expressed as developmental quotients [DQ = (developmental age/chronologic age)*100]. The full-scale CAT/CLAMS+GM DQ (full-scale DQ) is the mean of the CAT DQ, the CLAMS DQ, and GM DQ. Full-scale DQ ≥ 75 is considered as normal value (the child has a normal development).|in 12 weeks of the treatment|Per Protocol set|||Percentage of patients|||Number
2536670|NCT03159611|Secondary|Mean Cognitive Adaptive Test/Clinical Linguistic and Auditory Milestone Scale (CAT/CLAMS) Score by the End of the Treatment Course Compared to Baseline (Time Frame: 0 Weeks, 4 Weeks, 8 Weeks, 12 Weeks)|The Clinical Adaptive Test/Clinical Linguistic and Auditory Milestone Scale (CAT/CLAMS) Consists of Three batteries: Clinical adaptive test (CAT), clinical linguistic and auditory milestone scale (CLAMS), and Gross motor (GM). CAT is the visual-motor problem-solving battery; the score on the CAT is based on the child's performance with the administered items. CLAMS is the language battery of the test; the score on the CLAMS is based on the parent's report of language skill attainment. GM evaluates motor skills; the score on the GM is based on the direct observation of a child and examination by the neurologist. The scores from the CAT/CLAMS+GM are expressed as developmental quotients [DQ = (developmental age/chronologic age)*100]. The full-scale CAT/CLAMS+GM DQ (full-scale DQ) is the mean of the CAT DQ, the CLAMS DQ, and GM DQ. Full-scale DQ ≥ 75 is considered as normal value (the child has a normal development).|in 12 weeks of the treatment|Per Protocol set|||score on a scale||Standard Deviation|Mean
2536671|NCT03159611|Secondary|Percentage of Patients With Normal Psychomotor Development (≥ 27 Scores on Jurba-Mastyukova Scale) by the End of Treatment Course Compared to Baseline (Time Frame: 0 Weeks, 4 Weeks, 8 Weeks, 12 Weeks)|"The Jurba-Mastyukova scale is meant to evaluate motor and mental development of 1-12-month-old infants. 10 developmental domains are evaluated every month. The evaluation of each domain is based on a 4-point system (the optimal development equals 3 points, its absence = 0 points). The maximum score is 30 points; 27-29 points are considered as age-appropriate normal value; 23-26 points - as an absolute risk group; 13-22 points - as developmental retardation; below 13 points - as severe global developmental delay."|in 12 weeks of the treatment|Per Protocol set|||Percentage of patients|||Number
2536672|NCT03159611|Primary|Percentage of Patients With a 4 and More Point Increase of the Total Score According to Jurba-Mastyukova Psychomotor Development Scale by the End of the Treatment|"The Jurba-Mastyukova scale is meant to evaluate motor and mental development of 1-12-month-old infants. 10 developmental domains are evaluated every month. The evaluation of each domain is based on a 4-point system (the optimal development equals 3 points, its absence = 0 points). The maximum score is 30 points; 27-29 points are considered as age-appropriate normal value; 23-26 points - as an absolute risk group; 13-22 points - as developmental retardation; below 13 points - as severe global developmental delay."|in 12 weeks of the treatment|Per Protocol set|||percentage of participants|||Number
2536673|NCT03159468|Primary|Sexual Aggression Intentions|"Sexual Aggression Intentions Scale. Construct: Self-reported ratings of sexual aggression likelihood in a hypothetical scenario. Minimum value of 1 (Very unlikely). Maximum value of 7 (Very likely). Higher scores mean a worse outcome."|Within one hour after receiving the intervention||||score on a scale||Standard Deviation|Mean
2536674|NCT03159299|Other Pre-specified|Fidelity of Yo Puedo Sessions|This will be collected by researchers to evaluate feasibility. A study Co-Investigator will observe 10% of sessions to evaluate fidelity of Yo Puedo sessions.|through study completion, about 1 year|||||||
2536675|NCT03159299|Other Pre-specified|Protocol Implementation|This will be collected by researchers to evaluate feasibility. The CHWs will complete a Protocol Implementation Form after each session that documents attendance, length of the session, content of session, protocol implementation, and any deviation from protocol implementation|through study completion, about 1 year|||||||
2536676|NCT03159299|Other Pre-specified|Attrition|This will be collected by researchers to evaluate feasibility. The number of participants who do not complete the study interventions and the reasons why will be recorded by study personnel.|through study completion, about 1 year|||||||
2536677|NCT03159299|Other Pre-specified|Rate of Recruitment|Rates of recruitment will be collected by researchers to evaluate feasibility.|through study completion, about 1 year|||||||
2536678|NCT03159299|Other Pre-specified|Satisfaction With Program|This measure will be used to evaluate the acceptability of the Yo Puedo program. Participants will be given a short survey and interview about their experience and satisfaction with the program.|6 months|||||||
2536679|NCT03159299|Secondary|Change in Diabetes Self-Efficacy From Baseline|Self-efficacy will be measured by the Stanford Diabetes Self-Efficacy Scale, an 8-item scale specific to T2D self-management self-efficacy.|6 months|||||||
2536680|NCT03159299|Secondary|Change in Diabetes Self-Efficacy From Baseline|Self-efficacy will be measured by the Stanford Diabetes Self-Efficacy Scale, an 8-item scale specific to T2D self-management self-efficacy.|3 months|||||||
2536681|NCT03159299|Secondary|Diabetes Self-Efficacy|Self-efficacy will be measured by the Stanford Diabetes Self-Efficacy Scale, an 8-item scale specific to T2D self-management self-efficacy.|Baseline|||||||
2536682|NCT03159299|Secondary|Change in Physical Activity From Baseline|Physical activity will be measured by accelerometer, using the Actigraph Actigraphy, a 3-axial accelerometer.|6 months|||||||
2536697|NCT03159299|Primary|Change in Hemoglobin A1C From Baseline|The change in A1C from baseline to 6 months is the result of the Generalized Linear Mixed Models (GLMM) with an intent-to-treat analysis that was used. HbA1c was measured from finger stick blood sample.|Baseline, 3, 6 months|Intention to treat analysis included all observations for all relevant time points used in the calculation.|||percentage HbA1c||Standard Deviation|Mean
2536698|NCT03159260|Secondary|Change in Symptom Log Over 4 Weeks|Patients will track the number of times their leg cramps/spasms for the first 2 weeks without intervention and then how many times during the two weeks using the intervention.|Weeks 1, 2, 3 and 4|Population analyzed based off of the number of subjects who completed the study, see Overall Study Participant Flow section|||Leg Cramps and Spasm||Standard Error|Mean
2536699|NCT03159260|Primary|Change in Modified Patient Specific Functional Scale Over 4 Weeks|The Modified Patient Specific Functional Scale is used to quantify activity limitation and measure functional outcome for patients with any orthopaedic condition. Three important activities that are unable to be done or are having difficulty are rated from 0 to 10, 0 being unable to perform and 10 being able to perform activity at the same level as before injury or problem. The total score is the sum of the activity scores divided by the number of activities, ranging from 0 (worst outcome) to 10 (best outcome).|Baseline, 2 weeks, and 4 weeks|Population analyzed based off of the number of subjects who completed the study, see Overall Study Participant Flow section|||units on a scale||Standard Error|Mean
2536700|NCT03159260|Primary|Change in Pittsburgh Sleep Quality Index Over 4 Weeks|"The Pittsburgh Sleep Quality Index is used to measure the quality and patterns of sleep in adults. It differentiates poor from good sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. The seven component scores are added together for a global score ranging from 0 to 21, 0 indicating no difficulty and 21 indicating severe difficulties."|Baseline, 2 weeks, and 4 weeks|Population analyzed based off of the number of subjects who completed the study, see Overall Study Participant Flow section|||units on a scale||Standard Error|Mean
2536701|NCT03159260|Primary|Change in Beck Depression Scale Over 4 Weeks|The Beck Depression Scale is one of the most widely used psychometric tests for measuring the severity of depression. The score is calculated by adding up the score for each of the twenty-one questions by counting the number to the right of each question marked. The highest possible total for the whole test would be sixty-three and the lowest possible score for the test would be zero. The level of depression is evaluated by: 0-10 (These ups and downs are considered normal);11-16 (Mild mood disturbance); 17-20 (Borderline clinical depression); 21-30 (Moderate depression); 31-40 (Severe depression); over 40 (Extreme depression).|Baseline, 2 weeks, and 4 weeks|Population analyzed based off of the number of subjects who completed the study, see Overall Study Participant Flow section|||units on a scale||Standard Error|Mean
2536702|NCT03159260|Primary|Change in Restless Legs Syndrome Quality of Life Instrument (RLSQoL) Over 4 Weeks|Restless Legs Syndrome Quality of Life Instrument (RLSQoL) assesses the impact of restless legs symptoms on daily life, emotional well-being, social life and work life in adults 21 years and over. Each subsection is totaled separately and summed to form a total score from 0-100. Higher scores on the RLSQoL overall life impact score indicate a better quality of life. The subsections include Social Life, Daily Function, Sleep Quality, and Emotional Well-being. Each subsection questions are summed, divided by total score, and multiplied by 100 to form a scale of 0 (worst outcome) to 100 (best outcome).|Baseline, 2 weeks, and 4 weeks|Population analyzed based off of the number of subjects who completed the study, see Overall Study Participant Flow section.|||units on a scale||Standard Error|Mean
2536703|NCT03159143|Secondary|Overall Survival|The overall survival will be calculated as the number of months from the date of first treatment until death or the cut-off date.|Up to 4 years|Patients received at least one cycle of docetaxel and oxaliplatin and were assessed for toxic effects.|||months||95% Confidence Interval|Median
2536704|NCT03159143|Secondary|Disease Control Rate (DCR)|Percentage of patients who achieved complete response, partial response and stable disease. DCR will be calculated from the first day of the first cycle to the date of metastatic or primary tumor relapse, or last contact date, or date of death (if death comes before disease progression), or data cut-off.|Up to 4 years|Patients who received at least one cycle of docetaxel and oxaliplatin and were assessed for toxic effects|||percentage of participants||95% Confidence Interval|Median
2536705|NCT03159143|Secondary|Time to Progression (TTP)|Time to progression (TTP) will be calculated as number of months from the date of first treatment to the date of disease progression or the date of death (disease-related causes) or the cut-off date.|Up to 4 years|Patients received at least one cycle of docetaxel and oxaliplatin and were assessed for toxic effects.|||months||95% Confidence Interval|Median
2536706|NCT03159143|Primary|Response Rate|Percentage of patients who experienced a greater than or equal to a 30% reduction in measurable disease, as per the RECIST criteria.|Up to 4 years|Patients who received between 1 and 6 cycles of oxaliplatin with docetaxel.|||percentage of participants||95% Confidence Interval|Number
2536707|NCT03158220|Secondary|Percentage of Participants Who Seroconverted to Each of the Anti-HPV Types|Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. The percentage of participants who were seronegative on Day 1 and have anti-HPV titer greater or equal to the type-specific serostatus cutoff at 4 weeks postdose 3 was assessed.|4 weeks post vaccination 3 (Month 7)|Received all 3 vaccinations of the correct dose and within acceptable day ranges, had evaluable serology results at Day 1 and Month 7, must have been seronegative to the appropriate HPV type at Day 1 and had no protocol deviations that could interfere with the evaluation of participant's immune response to the 9vHPV vaccine.|||Percentage of Participants||95% Confidence Interval|Number
2536708|NCT03158220|Secondary|Percentage of Participants With Elevated Temperature (Fever)|Participants were asked to record oral body temperature in the Vaccination Report Card. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) was assessed.|Up to 5 days post any vaccination|All participants that received at least 1 vaccination and had available data for endpoint.|||Percentage of Participants|||Number
2536880|NCT03152136|Other Pre-specified|Change in Clinical Global Impression of Severity (CGI-S)|Tremor severity will be assessed with the 7-point CGI-S scale at baseline for all arms. For TAPS and sham arms, CGI-S will also be assessed during and after stimulation.|Collected before, during, and after in-office stimulation sessions at Week 0, Week 2, and Week 4|||||||
2536709|NCT03158220|Secondary|Percentage of Participants That Reported at Least 1 Systemic Adverse Event|An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs. The percentage of participants that reported at least 1 systemic AE was assessed|Up to 15 days post any vaccination|All participants that received at least 1 vaccination and had available data for endpoint.|||Percentage of Participants|||Number
2536710|NCT03158220|Secondary|Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event|Participants were asked to record any injection-site reactions prompted in the Vaccination Report Card, i.e., injection-site tenderness, swelling, or redness, occurring after each study vaccination (solicited injection-site reactions). The percentage of participants with 1 or more solicited injection-site AE was assessed.|Up to 5 days post any vaccination|All participants that received at least 1 vaccination and had available data for endpoint.|||Percentage of Participants|||Number
2536711|NCT03158220|Secondary|Percentage of Participants Who Had Study Vaccine Discontinued Due to Adverse Event.|An adverse event is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants who discontinued the study vaccine due to an adverse event regardless of study completion status was assessed.|Up to 1 month post vaccination 3 (up to 7 months)|All participants that received at least 1 vaccination and had available data for endpoint.|||Percentage of Participants|||Number
2536712|NCT03158220|Secondary|Percentage of Participants That Experienced at Least 1 Adverse Event (AE)|An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with 1 or more AEs was assessed.|Up to 1 month post vaccination 3 (up to 7 months)|All participants that received at least 1 vaccination and had available data for endpoint.|||Percentage of Participants|||Number
2536713|NCT03158220|Primary|Anti-HPV Geometric Mean Titers (GMTs) for Each Anti-HPV Type|Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL). Statistical comparisons between arms was performed for the HPV types considered oncogenic (HPV Types 16/18/31/33/45/52/58).|4 weeks post vaccination 3 (Month 7)|Received all 3 vaccinations of the correct dose and within acceptable day ranges, had evaluable serology results at Day 1 and Month 7, must have been seronegative to the appropriate HPV type at Day 1 and had no protocol deviations that could interfere with the evaluation of participant's immune response to the 9vHPV vaccine.|||mMU/mL||95% Confidence Interval|Geometric Mean
2536714|NCT03158038|Secondary|Percentage of Participants Who Require Antipyretic and/or Analgesic Medication|Percentage of participants who require antipyretic and/or analgesic medication were reported.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants who were randomized and treated with investigational product.|||Percentage of participants|||Number
2536715|NCT03158038|Secondary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs were serious events between administration of study drug and up to 181 days after the dose that are absent before treatment or that worsen relative to pretreatment state. An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. Results were given for TESAEs and NOCDs reported up to 29 days and 181 days after vaccination.|Baseline (Day 1) up to Day 29 and Day 181|The ITT population included all participants who were randomized and treated with investigational product.|||Participants|||Count of Participants
2536716|NCT03158038|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were events between administration of study drug and up to 15 days after vaccination that are absent before treatment or that worsened relative to pre-treatment state. Results were given for AEs reported up to 8 days and 15 days after vaccination.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants who were randomized and treated with investigational product.|||Participants|||Count of Participants
2536717|NCT03158038|Secondary|Percentage of Participants With Solicited Symptoms|Solicited symptoms are predefined symptoms or events specifically inquired about and assessed daily after vaccine administration up to 15 days after vaccination. The solicited symptoms include fever greater than (>) 100.0 degrees F (37.8 degrees Celsius), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity and headache. Results were reported for all solicited symptoms except fever >=101 degrees F (reported as primary outcome) up to 8 days after vaccination and all solicited symptoms up to 15 days after vaccination.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants who were randomized and treated with investigational product.|||Percentage of Participants|||Number
2536718|NCT03158038|Primary|Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)|Percentage of participants with fever defined as oral temperature >=101 degrees F were reported.|Baseline (Day 1) up to Day 8|The intent-to-treat (ITT) population included all participants who were randomized and treated with investigational product.|||Percentage of Participants|||Number
2536721|NCT03157583|Primary|Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values|Arithmetic mean of all valid SPFi values of each product on each participant was calculated from the individual Minimal Erythemal Dose (MED) on product treated (MEDp) test sites in relation to unprotected (MEDu) test sites 16-24 hours after exposure to ultraviolet (UV) radiation. SPFi = MEDp/MEDu. No inferential statistical analysis was performed for this outcome.The provisional MEDu was the lowest dose of UV radiation that produces the first perceptible unambiguous erythema with defined borders appearing over most of the field of UV exposure.Higher values represents increased SPF protection.|Up to 24 hours post UV exposure|Analysis population included all randomized participants who underwent irradiation at Visit 4. Here, number analyzed signifies participants with available data for this outcome measure.|||Ratio||95% Confidence Interval|Mean
2536722|NCT03157531|Post-Hoc|Number of Lesions With 6-Month Patency [Not a Study Pre-specified Endpoint]|"Defined as < 50% stenosis at the treated lesion, as assessed quantitatively by duplex ultrasound when the peak systolic velocity ratio is < 2.5.~* As assessed quantitatively by the core laboratory.~This is not a study pre-specified endpoint."|6 months (+/-14 days) post procedure|Unavailable PSVR for 14 participants (17 lesions) from 95 participants (107 lesions): 3 participants (4 lesions) not diagnostic due to technical incompliance at exam; 5 participants (5 lesions) lost to follow-up; 2 participants (3 lesions) died; 4 participants (5 lesions), core lab could not calculate PSVR.|||lesions|lesions||Count of Units
2536723|NCT03157531|Post-Hoc|PAD Measurements at the 6-month Visit Post-procedure Compared to Baseline [Not a Study Pre-specified Endpoint] (2)|c) Ankle-Brachial Index (ABI): ankle/arm blood pressure ratio. Normal value ranges between 0.9-1.3. Under 0.9 index means blood has a difficult time getting to legs & feet; 0.4-0.9 indicates mild-moderate PAD; 0.4 and lower indicates severe PAD. Positive difference between time-points represents a clinical improvement through time and vice versa.|6-month (+/-14 days) post-procedure|Only available data for comparison at the two time-points is presented for each parameter .|||ratio||Standard Error|Mean
2536724|NCT03157531|Post-Hoc|PAD Measurements at the 6-month Visit Post-procedure Compared to Baseline [Not a Study Pre-specified Endpoint] (1)|"Rutherford Classification: a doctor determined 7 stages scale (0= Asymptomatic, 6= Severe ischemic ulcers/frank gangrene) representing PAD progress, lower value = better outcome. Positive difference between time-points represents a clinical deterioration through time and vice versa.~Walking Impairment Questionnaire (WIQ): a patient fulfilled survey to grade physical ability representing PAD progress, has 3 sub-scales (walking speed, distance, climbing stairs), when the total score ranges between 0-100, higher value = better outcome. Positive difference between time-points represents a clinical improvement through time and vice versa."|6-month (+/-14 days) post-procedure|Only available data for comparison at the two time-points is presented for each parameter .|||score on a scale||Standard Error|Mean
2536725|NCT03157531|Post-Hoc|Number of Participants With Freedom From 6 Months Major Adverse Events (MAEs) [Not a Study Pre-specified Endpoint]|"Unplanned target limb amputation above the ankle~Clinically Driven Target Lesion Revascularization (CDTLR)~Cardiovascular related deaths~As adjudicated by the Clinical Event Committee (CEC)."|6 months (+/-14 days) post procedure|3 CD-TLRs were possibly related to device & definitely related to index procedure, per CEC. 8 participants out of total 97 with unavailable data: 3 subjects were lost to follow-up before 6-month visit was completed, 1 subject died before 6-month visit, and 3 other subjects had their 6-month visit outside of the allowable window (before Day 166).|||Participants|||Count of Participants
2536726|NCT03157531|Secondary|Number of Lesions With Clinical Success at 30 Days|"Defined as < 50% stenosis at the treated lesion, as assessed quantitatively by duplex ultrasound when the peak systolic velocity ratio is < 2.5.~* As assessed quantitatively by the core laboratory."|30 (+/-5) days post procedure|Unavailable PSVR for 13 participants (14 lesions) from 95 participants (107 lesions): 5 participants (6 lesions) not diagnostic due to technical incompliance at exam; 3 participants (3 lesions) lost to follow-up; 1 participant (1 lesion) died; 4 participants (4 lesions), core lab could not calculate PSVR, yet were considered patent by absolute PSV.|||lesions|lesions||Count of Units
2536727|NCT03157531|Secondary|PAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (2)|c) Ankle-Brachial Index (ABI): ankle/arm blood pressure ratio. Normal value ranges between 0.9-1.3. Under 0.9 index means blood has a difficult time getting to legs & feet; 0.4-0.9 indicates mild-moderate PAD; 0.4 and lower indicates severe PAD. Positive difference between time-points represents a clinical improvement through time and vice versa.|30 (+/-5) days post procedure|Only available data for comparison at the two time-points is presented for each parameter .|||ratio||Standard Error|Mean
2536728|NCT03157531|Secondary|PAD Measurements at the 30-day Visit Post-procedure Compared to Baseline (1)|"Rutherford Classification: a doctor determined 7 stages scale (0= Asymptomatic, 6= Severe ischemic ulcers/frank gangrene) representing PAD progress, lower value = better outcome. Positive difference between time-points represents a clinical deterioration through time and vice versa.~Walking Impairment Questionnaire (WIQ): a patient fulfilled survey to grade physical ability representing PAD progress, has 3 sub-scales (walking speed, distance, climbing stairs), when the total score ranges between 0-100, higher value = better outcome. Positive difference between time-points represents a clinical improvement through time and vice versa."|30 (+/-5) days post procedure|Only available data for comparison at the two time-points is presented for each parameter .|||scores on a scale||Standard Error|Mean
2536729|NCT03157531|Secondary|Number of Lesions With Residual Stenosis by Angiography of ≤ 30% Post-procedure Including Any Adjunctive Therapy, With no Flow Limiting Dissection.|"Number of Lesions with residual stenosis by angiography of ≤ 30% post-procedure including any adjunctive therapy, with no flow limiting dissection.~* As assessed quantitatively by the core laboratory."|Perioperative|Unavailable data for primary efficacy endpoint analysis for 2 participants out of the 97.|||lesions|lesions||Count of Units
2536730|NCT03157531|Secondary|Number of Lesions With Freedom From Non-Clinically Significant [1] Device Related Adverse Events (AEs) in the Target Vessel|"Perforation~Dissection~Distal embolization or in situ thrombus~Pseudoaneurysm~As adjudicated by the Clinical Event Committee (CEC). [1] Note: non-Clinically Significant AEs are defined as adverse events that DO NOT REQUIRE any intervention, treatment or any hospitalization or its prolongation, in order to prevent death, persistent/significant disability/incapacity or congenital anomaly/birth defect."|Perioperative and up to 30 (+/-5) days post procedure|All the 16 cases were type A (11) and B (5) dissections only. No perforations, major dissections, emboli or pseudoaneurysm.|||lesions|lesions||Count of Units
2536731|NCT03157531|Secondary|Number of Lesions With Freedom From Clinically Significant [1] Device Related Adverse Events (AEs) Requiring Intervention in the Target Vessel|"Perforation~Dissection~Distal embolization or in situ thrombus~Pseudoaneurysm~As adjudicated by the Clinical Event Committee (CEC). [1] Note: Clinically Significant AEs are defined as adverse events that REQUIRE any intervention,treatment or any hospitalization or its prolongation, in order to prevent death, persistent/significant disability/incapacity or congenital anomaly/birth defect."|Perioperative and up to 30 (+/-5) days post procedure||||lesions|lesions||Count of Units
2536732|NCT03157531|Primary|Number of Participants With Freedom From 30 Days Major Adverse Events (MAEs)|"Unplanned target limb amputation above the ankle~Clinically Driven Target Lesion Revascularization (CDTLR)~Cardiovascular related deaths~As adjudicated by the Clinical Event Committee (CEC).~This endpoint will be met if the freedom from MAE rate is greater than 85%."|30 (+/-5) days post procedure|1 Cardiovascular related death was unrelated to the device per the CEC. Four participants out of the 97 with unavailable data: two were lost to follow-up before the 30-day visit was completed, and two others had their 30-day visit outside of the allowable window (day 16 and day 23).|||Participants|||Count of Participants
2536733|NCT03157531|Primary|Acute Technical Success|"Reduction from baseline in residual diameter stenosis (%), prior to any adjunctive therapy, achieved by the B-Laser™ catheter~A change (always a reduction) between two time points (baseline time-point and post B-Laser treatment time-point, both perioperative) is reported:~As assessed quantitatively by the core laboratory.~This endpoint will be met if the mean reduction in residual diameter stenosis is greater than 20%.~A greater reduction means better results."|Perioperative|Unavailable angiographic data for primary efficacy endpoint analysis for 2 participants with 2 lesions out of the 97 participants with 109 lesions (these 2 were considered ITT and not PP).|||Change in RDS (%)|lesions|Standard Deviation|Mean
2536734|NCT03157232|Primary|Sub-Range Performance Equivalence of Rainbow DCI and R1-25 Sensors by ARMS Calculation|Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours per subject||||g/dL|||Number
2536735|NCT03155269|Secondary|Change From Baseline in Serum Vitamin-B12 at 3 Months and 6 Months|Serum vitamin-B12 is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum vitamin-B12 was analysed using biochemical tests from the samples stored. Increased serum vitamin-B12 is associated with improved bone health.|At baseline, at 3 months and 6 months|The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||pmol/L||Standard Deviation|Mean
2536736|NCT03155269|Secondary|Change From Baseline in Plasma Vitamin-B6 at 3 Months and 6 Months|Plasma vitamin-B6 is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Plasma vitamin-B6 was analysed using biochemical tests from the samples stored. Increased plasma vitamin-B6 is associated with improved bone health.|At baseline, at 3 months and 6 months|The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||nmol/L||Standard Deviation|Mean
2536737|NCT03155269|Secondary|Change From Baseline in Serum Folic Acid (Folate) at 3 Months and 6 Months|Serum folic acid (folate) is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Plasma Zn was analysed using biochemical tests from the samples stored. Increased serum folate is associated with improved bone health.|At baseline, at 3 months and 6 months|The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||nmol/L||Standard Deviation|Mean
2536738|NCT03155269|Secondary|Change From Baseline in Plasma Zinc (Zn) at 3 Months and 6 Months|Plasma Zn is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Plasma Zn was analysed using biochemical tests from the samples stored. Increased plasma Zn is associated with improved bone health.|At baseline, at 3 months and 6 months|The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||mcmol/L||Standard Deviation|Mean
2536739|NCT03155269|Secondary|Change From Baseline in Serum Selenium (Se) at 3 Months and 6 Months|Serum Se is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum Se was analysed using biochemical tests from the samples stored. Increased serum Se is associated with improved bone health.|At baseline, at 3 months and 6 months|The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||Micromole per liter (mcmol/L)||Standard Deviation|Mean
2536740|NCT03155269|Secondary|Change From Baseline in Serum Vitamin D3 Using 25-hydroxycholecalciferol (25 OH D3) at 3 Months and 6 Months|Serum vitamin-D3 is used to analyse the status of vitamin-D profile which is necessary for healthy bones. The marker used for analyzing serum vitamin-D3 was 25 OH D3. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum vitamin-D3 was analysed using biochemical tests from the samples stored. Increased serum vitamin-D3 is associated with improved bone health.|At baseline, at 3 months and 6 months|The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||nmol/L||Standard Deviation|Mean
2536741|NCT03155269|Secondary|Change From Baseline in Total Alkaline Phosphatase (ALP) at 3 Months and 6 Months|ALP is a diagnostic marker of which is used to assess bone mineral density for assessment of healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum ALP was analysed using biochemical tests from the samples stored. Increased serum ALP is associated with improved bone health.|At baseline, at 3 months and 6 months|The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||Units per liter (U/L)||Standard Deviation|Mean
2536742|NCT03155269|Secondary|Change From Baseline in Serum Phosphorus at 3 Months and 6 Months|Serum phosphorus is a diagnostic marker for assessment of healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum phosphorus was analysed using biochemical tests from the samples stored. Increased serum phosphorus is associated with improved bone health.|At baseline, at 3 months and 6 months|The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||mmol/L||Standard Deviation|Mean
2536743|NCT03155269|Secondary|Change From Baseline in Serum Calcium at 3 Months and 6 Months|Serum calcium is used to compare calcium concentration status which defines the healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum calcium was analysed using biochemical tests from the samples stored. Increased serum calcium is associated with improved bone health.|At baseline, at 3 months and 6 months|The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2536744|NCT03155269|Secondary|Change From Baseline in Urinary Calcium at 3 Months and 6 Months|Urinary calcium is used to compare calcium concentration status which defines the healthy bones. After 3 months and 6 months of taking the allocated product, spot urinary sample were collected. Urinary calcium was analysed using biochemical tests from the samples stored. Decreased urinary calcium is associated with improved bone health.|At baseline, at 3 months and 6 months|The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||Millimoles per moles (mmol/mol)||Standard Deviation|Mean
2536745|NCT03155269|Secondary|Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 Months|PTH is used to compare calcium concentration status which defines the healthy bones. Intact PTH is the biologically active form and is secreted when the calcium level is low. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. PTH serum was analysed using biochemical tests from the samples stored. Decreased s-PTH is associated with improved bone health.|At baseline, at 3 months and 6 months|The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||Picomole per liter (pmol/L)||Standard Deviation|Mean
2536746|NCT03155269|Secondary|Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 Months|BSAP is a bone formation surrogate marker which is used to assess the bone health. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. BSAP serum was analysed using biochemical tests from the samples stored. Increased s-BSAP is associated with improved bone health.|At baseline, at 3 months and 6 months|The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||mcg/L||Standard Deviation|Mean
2536747|NCT03155269|Secondary|Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months|P1NP is a bone formation surrogate marker which is used to assess the bone health being the most abundant protein of bone matrix. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. P1NP serum was analysed using biochemical tests from the samples stored. Increased s-P1NP is associated with improved bone health.|At baseline, at 3 months and 6 months|The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||mcg/L||Standard Deviation|Mean
2536748|NCT03155269|Secondary|Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 Months|NTX-1 is a bone resorption surrogate marker which is used to assess the bone health. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. NTX-1 serum was analysed using biochemical tests from the samples stored. Decreased s-NTX-1 is associated with improved bone health. The unit of measurement is nanomole bone collagen equivalent (NM BCE).|At baseline, at 3 months and 6 months|The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||NM BCE||Standard Deviation|Mean
2536749|NCT03155269|Secondary|Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 Months|Urinary-CTX-1 is a bone resorption surrogate marker which is used to assess the bone health. After 3 months and 6 months of taking the allocated product, spot urinary sample were collected. CTX-1 urine levels were analysed using biochemical tests from the samples stored. Decreased urinary CTX-1 is associated with improved bone health.|At baseline, at 3 and 6 months|The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||mcg/L||Standard Deviation|Mean
2536750|NCT03155269|Secondary|Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 3 Months|c-OC/ uc-OC is considered as a surrogate marker of bone formation which is used to assess the bone health. After 3 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. c-OC/ uc-OC levels were analysed using biochemical tests from the samples stored. Increased c-OC/ uc-OC is associated with improved bone health.|At baseline and at 3 months|The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||Ratio||Standard Deviation|Mean
2536751|NCT03155269|Secondary|Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 3 Months|s-CTX-1 is a bone resorption marker which is used to assess the bone health. After 3 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. CTX-1 serum was analysed using biochemical tests from the samples stored. Decreased s-CTX-1 is associated with improved bone health.|At baseline and at 3 months|The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||mcg/L||Standard Deviation|Mean
2536752|NCT03155269|Primary|Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 Months|c-OC/ uc-OC is considered as a surrogate marker of bone formation which is used to assess the bone health. After 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. c-OC/ uc-OC levels were analysed using biochemical tests from the samples stored. Increased c-OC/ uc-OC is associated with improved bone health.|At baseline and 6 months|The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||Ratio||Standard Deviation|Mean
2536753|NCT03155269|Primary|Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months|s-CTX-1 is a bone resorption marker which is used to assess the bone health. After 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. CTX-1 serum was analysed using biochemical tests from the samples stored. Decreased s-CTX-1 is associated with improved bone health.|At baseline and at 6 months|The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.|||Micrograms per litres (mcg/L)||Standard Deviation|Mean
2536754|NCT03155178|Other Pre-specified|Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment|Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale: 0=no reaction, 1=mild, 2=moderate, 3=severe.|Assessed at baseline (pre-treatment) and 10 minutes post-treatment, 48 hours post-treatment, 72 hours post-treatment, 96 hours post-treatment|Subjects meeting required baseline counts: greater or equal to 3.00 log10 CFU/cm^2 on the abdominal region and greater than or or equal to 5.00 log10 CFU/cm^2 on the inguinal region.|||sites|||Number
2536755|NCT03155178|Secondary|Change in Skin Flora Relative to 10 Minutes Post-prep Application|Log10 CFU/cm^2 regrowth of skin flora, relative to 10-minute post-treatment log10 CFU/cm^2, at 3 defined post-treatment sampling times.|10-minute post-treatment, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment|The secondary analysis data set used a Modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of either > or equal to 3.0 log10 CFU/cm^2 on the abdomen test site or 5.0 log10 CFU/cm^2 on the inguinal test|||log10 CFU/cm^2||Standard Deviation|Mean
2536756|NCT03155178|Primary|Measurement of Skin Flora Recovery Post-prep Application|The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm^2) of skin flora at 3 defined post-treatment sampling times.|Baseline, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment|The primary analysis data set used a Modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of either > or equal to 3.0 log10 CFU/cm^2 on the abdomen test site or > or equal to 5.0 log10 CFU/cm^2 on the inguinal test site.|||log10 CFU/cm^2||Standard Deviation|Mean
2536757|NCT03154333|Secondary|The Proportion of Subjects Who Achieved Success on the Investigator's Global Assessment (IGA)|"The investigator's global assessment (IGA) is a five-point scale that is used for overall clinical assessment of severity of disease and classifies EBS-involved skin with a score ranging from 0-4. Success on the IGA was defined as ≥2-point reduction from Baseline to Visit 6 (Week 8).~IGA Scoring:~0 = Clear; 1 = Near Clear; 2 = Mild; 3 = Moderate; 4 = Severe~Minimum score = 0 Maximum score = 4; higher score = worse outcome"|Baseline to Week 8|All efficacy analyses were conducted using the Intent to Treat (ITT) Population that consisted of all randomized subjects who were dispensed study drug. Subjects were included in the treatment group to which they were assigned.|||Participants|||Count of Participants
2536758|NCT03154333|Primary|Proportion of Subjects Who Achieved ≥ 60% Reduction in Body Surface Area (BSA) of EBS Lesions Within Assessment Area|Analysis of the proportion of subjects who achieved a ≥60% reduction in Body Surface Area (BSA) of EBS lesions within Assessment Area from Baseline to Week 8|Baseline to Week 8|All efficacy analyses were conducted using the Intent to Treat (ITT) Population that consisted of all randomized subjects who were dispensed study drug. Subjects were included in the treatment group to which they were assigned.|||Participants|||Count of Participants
2536759|NCT03154086|Primary|Part B: Tmax Following Repeat Dose Administration of GSK3352589|Blood samples were collected from participants for pharmacokinetic analysis including Tmax following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part B was conducted by non-compartmental methods.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14|Pharmacokinetic Parameter Population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).|||Hours||Full Range|Median
2536760|NCT03154086|Primary|Part B: Cmax Following Repeat Dose Administration of GSK3352589|Blood samples were collected from participants for pharmacokinetic analysis including Cmax following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part B was conducted by non-compartmental methods.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14|Pharmacokinetic Parameter Population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2536761|NCT03154086|Primary|Part B: Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0-tau]) Following Repeat Dose Administration of GSK3352589|Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-tau) following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part B was conducted by non-compartmental methods.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14|Pharmacokinetic Parameter Population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).|||Hour*Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2536762|NCT03154086|Primary|Part B: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to 24 Hours Post-dose (AUC [0-24]) Following Repeat Dose Administration of GSK3352589|Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-24) following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part B was conducted by non-compartmental methods.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14|Pharmacokinetic Parameter Population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).|||Hour*Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2536763|NCT03154086|Primary|Part B: AUC (0-t) Following Repeat Dose Administration of GSK3352589|Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-t) following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part B was conducted by non-compartmental methods.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 1; Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 10, 11, 12, 14, 16, 24 Hours Post-dose on Day 14|Pharmacokinetic Parameter Population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).|||Hour*Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2536764|NCT03154086|Primary|Part A: AUC (0-infinity) Following Single Dose Administration of GSK3352589- Food Effect|Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-infinity) following administration of GSK3352589 in fasted and fed condition to assess the effect of food on pharmacokinetics of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose|Pharmacokinetic Parameter Population|||Hours*Nanogram per milliliter||Standard Error|Least Squares Mean
2536765|NCT03154086|Primary|Part A: AUC (0-t) Following Single Dose Administration of GSK3352589- Food Effect|Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-t) following administration of GSK3352589 in fasted and fed condition to assess the effect of food on pharmacokinetics of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose|Pharmacokinetic Parameter Population|||Hours*Nanogram per milliliter||Standard Error|Least Squares Mean
2536766|NCT03154086|Primary|Part A: Cmax Following Single Dose Administration of GSK3352589-Food Effect|Blood samples were collected from participants for pharmacokinetic analysis following administration of GSK3352589 in fasted and fed condition to assess the effect of food on pharmacokinetics of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose|Pharmacokinetic Parameter Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2536881|NCT03152136|Other Pre-specified|Change in Clinical Rating Scale for Tremor (CRST) After Stimulation|A complete CRST examination (also known as the Fahn-Tolosa-Marin Tremor Rating Scale) will be completed at baseline for all arms: TAPS, sham, and 'no intervention.' For TAPS and sham arms, a subset of CRST relevant to upper limb tremor will be repeated after stimulation.|Collected before and after in-office stimulation sessions at Week 2|||||||
2536767|NCT03154086|Primary|Part A: Terminal Elimination Half-life (t1/2) Following Single Dose Administration of GSK3352589|Blood samples were collected from participants for pharmacokinetic analysis including t1/2 following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose|Pharmacokinetic Parameter Population. Only those participants with data available at specified time point were analyzed.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2536768|NCT03154086|Primary|Part A: Time to Reach Cmax (Tmax) Following Single Dose Administration of GSK3352589|Blood samples were collected from participants for pharmacokinetic analysis including Tmax following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose|Pharmacokinetic Parameter Population|||Hours||Full Range|Median
2536769|NCT03154086|Primary|Part A: Maximum Observed Plasma Concentration (Cmax) Following Single Dose Administration of GSK3352589|Blood samples were collected from participants for pharmacokinetic analysis including Cmax following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose|Pharmacokinetic Parameter Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2536770|NCT03154086|Primary|Part A: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of GSK3352589|Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-infinity) following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose|Pharmacokinetic Parameter Population. Only those participants with data available at specified time point were analyzed.|||Hour*Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2536771|NCT03154086|Primary|Part A: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Non-zero Concentration (AUC [0-t]) Following Single Dose Administration of GSK3352589|Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-t) following administration of GSK3352589. Pharmacokinetic analysis of GSK3352589 in Part A was conducted by non-compartmental methods. The PK Parameter population comprised of all randomized participants who received at least one dose of active treatment and who had GSK3352589 Pharmacokinetic parameter estimates from any portion of the study.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 24, 36, 48 Hours Post-dose|Pharmacokinetic Parameter Population comprised of all randomized participants who received at least one dose of active treatment and who had GSK3352589 Pharmacokinetic parameter estimates from any portion of the study.|||Hour*Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2536772|NCT03154086|Primary|Part B: Number of Participants With Abnormal Findings for Urine Parameters|Blood samples were collected for analysis of hematology parameters including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)|Safety population|||Participants|||Count of Participants
2536773|NCT03154086|Primary|Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 2|"Urine samples were collected from participants for analysis of specific gravity of urine. Urine parameters including bilirubin, glucose, ketones, leukocyte esterase, nitrite, occult blood, potential of hydrogen (pH), protein, specific gravity and Urobilinogen were analyzed by dipstick method. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period~1 (or the first available Dosing Period if Dosing Period 1 is unavailable)."|Baseline (Day -1) and Day 3|Safety population|||Participants|||Count of Participants
2536774|NCT03154086|Primary|Part A: Number of Participants With Abnormal Findings for Urine Parameters in Cohort 1 and Cohort 3|"Urine samples were collected from participants for analysis of specific gravity of urine. Urine parameters including bilirubin, glucose, ketones, leukocyte esterase, nitrite, occult blood, potential of hydrogen (pH), protein, specific gravity and Urobilinogen were analyzed by dipstick method. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period~1 (or the first available Dosing Period if Dosing Period 1 is unavailable)."|Baseline (Day-1) and Day 3|Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.|||Participants|||Count of Participants
2536775|NCT03154086|Primary|Part B: Change From Baseline in Albumin, Total Protein|Blood samples were collected for analysis of hematology parameters including albumin and total protein. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)|Safety population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).|||Grams per liter||Standard Deviation|Mean
2536776|NCT03154086|Primary|Part A: Change From Baseline in Albumin and Total Protein in Cohort 2|Blood samples were collected for analysis of clinical chemistry parameters including albumin and total protein. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population|||Grams per liter||Standard Deviation|Mean
2536777|NCT03154086|Primary|Part A: Change From Baseline in Albumin and Total Protein in Cohort 1 and 3|Blood samples were collected for analysis of clinical chemistry parameters including albumin, and total protein. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.|||Grams per liter||Standard Deviation|Mean
2536778|NCT03154086|Primary|Part B: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea|Blood samples were collected for analysis of hematology parameters including Calcium, Glucose, Potassium, Sodium, Urea. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)|Safety population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).|||Millimoles per liter||Standard Deviation|Mean
2536779|NCT03154086|Primary|Part A: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea in Cohort 2|Blood samples were collected for analysis of clinical chemistry parameters including Calcium, Glucose, Potassium, Sodium, Urea. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population|||Millimoles per liter||Standard Deviation|Mean
2536780|NCT03154086|Primary|Part A: Change From Baseline in Calcium, Glucose, Potassium, Sodium, Urea in Cohort 1 and 3|Blood samples were collected for analysis of clinical chemistry parameters including Calcium, Glucose, Potassium, Sodium, Urea. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.|||Millimoles per liter||Standard Deviation|Mean
2536781|NCT03154086|Primary|Part B: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin|Blood samples were collected for analysis of hematology parameters including bilirubin, creatinine, and direct bilirubin. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)|Safety population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).|||Micromoles per liter||Standard Deviation|Mean
2536782|NCT03154086|Primary|Part A: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin in Cohort 2|Blood samples were collected for analysis of clinical chemistry parameters including bilirubin, creatinine, and direct bilirubin. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population|||Micromoles per liter||Standard Deviation|Mean
2536783|NCT03154086|Primary|Part A: Change From Baseline in Bilirubin, Creatinine, Direct Bilirubin in Cohort 1 and 3|Blood samples were collected for analysis of clinical chemistry parameters including bilirubin, creatinine, direct bilirubin. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.|||Micromoles per liter||Standard Deviation|Mean
2536784|NCT03154086|Primary|Part B: Change From Baseline in ALT, AST and Alk Phos|Blood samples were collected for analysis of hematology parameters including ALT, AST and Alk Phos. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)|Safety population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).|||Units per liter||Standard Deviation|Mean
2536785|NCT03154086|Primary|Part A: Change From Baseline in ALT, AST and Alk Phos in Cohort 2|Blood samples were collected for analysis of clinical chemistry parameters including ALT, AST and Alk Phos. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population|||Units per liter||Standard Deviation|Mean
2536786|NCT03154086|Primary|Part A: Change From Baseline in Alanine Aminotransferase (ALT),Aspartate Aminotransferase (AST), Alkaline Phosphatase (Alk Phos) in Cohort 1 and 3|Blood samples were collected for analysis of clinical chemistry parameters including ALT, AST and Alk Phos. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.|||Units per liter||Standard Deviation|Mean
2536787|NCT03154086|Primary|Part B: Change From Baseline in Hematocrit|Blood samples were collected for analysis of hematology parameters including Hematocrit. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)|Safety population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).|||Proportion of red blood cells in blood||Standard Deviation|Mean
2536898|NCT03151551|Secondary|Percentage of Participants Achieving Minimal Disease Activity (MDA)|MDA is achieved if 5 of 7 outcome measures are fulfilled: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or BSA ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1.|Week 52||2020-08-31|08/2020||||
2536788|NCT03154086|Primary|Part A: Change From Baseline in Hematocrit in Cohort 2|Blood samples were collected for analysis of hematology parameters including Hematocrit. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population|||Proportion of red blood cells in blood||Standard Deviation|Mean
2536789|NCT03154086|Primary|Part A: Change From Baseline in Hematocrit in Cohort 1 and 3|Blood samples were collected for analysis of hematology parameters including Hematocrit. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2536790|NCT03154086|Primary|Part B: Change From Baseline in Erythrocyte MCH|Blood samples were collected for analysis of hematology parameters including Erythorocyte MCH. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)|Safety population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).|||Picogram||Standard Deviation|Mean
2536791|NCT03154086|Primary|Part A: Change From Baseline in Erythrocyte MCH in Cohort 2|Blood samples were collected for analysis of hematology parameters including Erythorocyte MCH. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population|||Picogram||Standard Deviation|Mean
2536792|NCT03154086|Primary|Part A: Change From Baseline in Erythorocyte Mean Corpuscular Hemoglobin (MCH) in Cohort 1 and 3|Blood samples were collected for analysis of hematology parameters including Erythorocyte MCH. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.|||Picogram||Standard Deviation|Mean
2536793|NCT03154086|Primary|Part B: Change From Baseline in Erythrocyte MCV|Blood samples were collected for analysis of hematology parameters including Erythrocyte MCV. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)|Safety population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).|||Femtoliter||Standard Deviation|Mean
2536794|NCT03154086|Primary|Part A: Change From Baseline in Erythrocyte MCV in Cohort 2|Blood samples were collected for analysis of hematology parameters including Erythrocyte MCV. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population|||Femtoliter||Standard Deviation|Mean
2536795|NCT03154086|Primary|Part A: Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) in Cohort 1 and Cohort 3|Blood samples were collected for analysis of hematology parameters including Erythrocyte MCV. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.|||Femtoliter||Standard Deviation|Mean
2536796|NCT03154086|Primary|Part B: Change From Baseline in Hemoglobin|Blood samples were collected for analysis of hematology parameters including hemoglobin. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)|Safety population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).|||Grams per liter||Standard Deviation|Mean
2536797|NCT03154086|Primary|Part A: Change From Baseline in Hemoglobin in Cohort 2|Blood samples were collected for analysis of hematology parameters including hemoglobin. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population|||Grams per liter||Standard Deviation|Mean
2536798|NCT03154086|Primary|Part A: Change From Baseline in Hemoglobin in Cohort 1 and 3|Blood samples were collected for analysis of hematology parameters including hemoglobin. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.|||Grams per liter||Standard Deviation|Mean
2545586|NCT02940327|Primary|CD14/41|Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.|72 hours after ECMO commencement||||percentage change||Standard Deviation|Mean
2536799|NCT03154086|Primary|Part B: Change From Baseline in Erythrocytes|Blood samples were collected for analysis of hematology parameters including Erythrocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)|Safety population. Only those participants with data available at specified time point were analyzed (reported by n=X in category titles).|||10^12 cells per liter||Standard Deviation|Mean
2536800|NCT03154086|Primary|Part A: Change From Baseline in Erythrocytes in Cohort 2|Blood samples were collected for analysis of hematology parameters including Erythrocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population|||10^12 cells per liter||Standard Deviation|Mean
2536801|NCT03154086|Primary|Part A: Change From Baseline in Erythrocytes in Cohort 1 and 3|Blood samples were collected for analysis of hematology parameters including Erythrocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.|||10^12 cells per liter||Standard Deviation|Mean
2536802|NCT03154086|Primary|Part B: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes|Blood samples were collected for analysis of hematology parameters including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -2), Day 7, Day 15 and Follow-up (Day 25)|Safety population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||10^9 cells per liter||Standard Deviation|Mean
2536803|NCT03154086|Primary|Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 2|Blood samples were collected for analysis of hematology parameters including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population|||10^9 cells per liter||Standard Deviation|Mean
2536804|NCT03154086|Primary|Part A: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, Leukocytes in Cohort 1 and Cohort 3|Blood samples were collected for analysis of hematology parameters including Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day -1) and Day 3|Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.|||10^9 cells per liter||Standard Deviation|Mean
2536805|NCT03154086|Primary|Part B: Average BSFS at Indicated Time Points|The BSFS describes 7 types of stool as following; Type 1-Separate hard lumps (hard to pass), Type 2-Sausage-shaped but lumpy, Type 3-Like a sausage but cracks on surface, Type 4-Like a sausage or snake, smooth and soft, Type 5- Soft blobs with clear cut edges, Type-6 Fluffy pieces with ragged edges, a mushy stool, and Type 7-Watery, no solid pieces (entirely liquid). BSFS was used by the participants during the study to capture the quality of stool using a 7-point scale ranging from Type 1=separate hard lumps like nuts (difficult to pass) to 7= watery, no solid pieces (entirely liquid).|Day -1, Days 1-3, Days 4-7, Days 1-7, Days 8-14|Safety population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Units on a scale||Standard Deviation|Mean
2536806|NCT03154086|Primary|Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 3|The BSFS describes 7 types of stool as following; Type 1-Separate hard lumps (hard to pass), Type 2-Sausage-shaped but lumpy, Type 3-Like a sausage but cracks on surface, Type 4-Like a sausage or snake, smooth and soft, Type 5- Soft blobs with clear cut edges, Type-6 Fluffy pieces with ragged edges, a mushy stool, and Type 7-Watery, no solid pieces (entirely liquid). BSFS was used by the participants during the study to capture the quality of stool using a 7-point scale ranging from Type 1=separate hard lumps like nuts (difficult to pass) to 7= watery, no solid pieces (entirely liquid).|Up to 30 days in Cohort 3|Safety population|||Participants|||Count of Participants
2536807|NCT03154086|Primary|Part A: Number of Participants With Different Stool Types Assessed Using BSFS in Cohort 2|The BSFS describes 7 types of stool as following; Type 1-Separate hard lumps (hard to pass), Type 2-Sausage-shaped but lumpy, Type 3-Like a sausage but cracks on surface, Type 4-Like a sausage or snake, smooth and soft, Type 5- Soft blobs with clear cut edges, Type-6 Fluffy pieces with ragged edges, a mushy stool, and Type 7-Watery, no solid pieces (entirely liquid). BSFS was used by the participants during the study to capture the quality of stool using a 7-point scale ranging from Type 1=separate hard lumps like nuts (difficult to pass) to 7= watery, no solid pieces (entirely liquid).|Up to 30 days in Cohort 2|Safety population|||Participants|||Count of Participants
2536826|NCT03154086|Primary|Part A: Number of Participants With SAEs and Non-SAEs in Cohort 3|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment.|Up to 30 days in Cohort 3|Safety population|||Participants|||Count of Participants
2536808|NCT03154086|Primary|Part A: Number of Participants With Different Stool Types Assessed Using Bristol Stool Form Scale (BSFS) in Cohort 1|The BSFS describes 7 types of stool as following; Type 1-Separate hard lumps (hard to pass), Type 2-Sausage-shaped but lumpy, Type 3-Like a sausage but cracks on surface, Type 4-Like a sausage or snake, smooth and soft, Type 5- Soft blobs with clear cut edges, Type-6 Fluffy pieces with ragged edges, a mushy stool, and Type 7-Watery, no solid pieces (entirely liquid). BSFS was used by the participants during the study to capture the quality of stool using a 7-point scale ranging from Type 1=separate hard lumps like nuts (difficult to pass) to 7= watery, no solid pieces (entirely liquid).|Up to 64 days in Cohort 1|Safety population|||Participants|||Count of Participants
2536809|NCT03154086|Primary|Part B: Change From Baseline in Body Temperature|Body temperature of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Pre-dose on Day 1), Day 1 (4 Hours Post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 (Pre-dose, 4 Hours Post-dose), Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, Day 14 (Pre-dose, 4 Hours Post-dose), Day 15, Follow-up (Day 25)|Safety population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Celsius||Standard Deviation|Mean
2536810|NCT03154086|Primary|Part A: Change From Baseline in Body Temperature in Cohort 2|Body temperature of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3|Safety population|||Celsius||Standard Deviation|Mean
2536811|NCT03154086|Primary|Part A: Change From Baseline in Body Temperature in Cohort 1 and Cohort 3|Body temperature of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3|Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.|||Celsius||Standard Deviation|Mean
2536812|NCT03154086|Primary|Part B: Change From Baseline in Pulse Rate|Pulse rate of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Pre-dose on Day 1), Day 1 (4 Hours Post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 (Pre-dose, 4 Hours Post-dose), Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, Day 14 (Pre-dose, 4 Hours Post-dose), Day 15, Follow-up (Day 25)|Safety population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Beats per minute||Standard Deviation|Mean
2536813|NCT03154086|Primary|Part A: Change From Baseline in Pulse Rate in Cohort 2|Pulse rate of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3|Safety population|||Beats per minute||Standard Deviation|Mean
2536814|NCT03154086|Primary|Part A: Change From Baseline in Pulse Rate in Cohort 1 and Cohort 3|Pulse rate of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3|Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.|||Beats per minute||Standard Deviation|Mean
2536815|NCT03154086|Primary|Part B: Change From Baseline in SBP and DBP|Blood pressure of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Pre-dose on Day 1), Day 1 (4 Hours Post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 (Pre-dose, 4 Hours Post-dose), Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, Day 14 (Pre-dose, 4 Hours Post-dose), Day 15, Follow-up (Day 25)|Safety population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Millimeters of mercury||Standard Deviation|Mean
2536816|NCT03154086|Primary|Part A: Change From Baseline in SBP and DBP in Cohort 2|Blood pressure of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3|Safety population|||Millimeters of mercury||Standard Deviation|Mean
2536827|NCT03154086|Primary|Part A: Number of Participants With SAEs and Non-SAEs in Cohort 2|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment.|Up to 30 days in Cohort 2|Safety population|||Participants|||Count of Participants
2536817|NCT03154086|Primary|Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Cohort 1 and Cohort 3|Blood pressure of participants was measured at indicated time points in a supine position after 5 minutes rest. Baseline is defined as the last available, non-missing assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2 and Day 3|Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.|||Millimeters of mercury||Standard Deviation|Mean
2536818|NCT03154086|Primary|Part B: Number of Participants With Abnormal ECG Findings|Triplicate 12-lead ECGs were obtained at indicated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline is defined as the last available, non-missing mean value of triplicate assessment prior to the first administration of study drug. The number of participants with abnormal CS and NCS findings for ECG parameters have been presented.|Baseline (Pre-dose on Day 1), Day 1 (4 Hours Post-dose), Day 7 (Pre-dose, 4 Hours Post-dose), Day 14 (Pre-dose, 4 Hours Post-dose), Follow-up (Day 25)|Safety population|||Participants|||Count of Participants
2536819|NCT03154086|Primary|Part A: Number of Participants With Abnormal ECG Findings in Cohort 2|Triplicate 12-lead ECGs were obtained at indicated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline is defined as the last available, non-missing mean value of triplicate assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). The number of participants with abnormal CS and NCS findings for ECG parameters have been presented.|Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2|Safety population|||Participants|||Count of Participants
2536820|NCT03154086|Primary|Part A: Number of Participants With Abnormal Electrocardiogram (ECG) Findings in Cohort 1 and Cohort 3|Triplicate 12-lead ECGs were obtained at indicated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT corrected (QTc) intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Baseline is defined as the last available, non-missing mean value of triplicate assessment prior to the first administration of study drug in Dosing Period 1 (or the first available Dosing Period if Dosing Period 1 is unavailable). The number of participants with abnormal clinically significant (CS) and not clinically significant (NCS) findings for ECG parameters have been presented.|Baseline (Pre-dose on Day 1), Day 1 (1, 4, 12 Hours Post-dose), Day 2|Safety population. In Cohort 1 and 3, participants were dosed in similar single ascending doses, cross-over sequences. Hence, combined totals for placebo arm is presented as pre-specified in protocol and reporting and analysis plan.|||Participants|||Count of Participants
2536821|NCT03154086|Primary|Part B: Number of Participants With Abnormal Findings After Physical Examination|A complete physical examination included, at a minimum, assessments of the skin, cardiovascular, respiratory, gastrointestinal and neurological systems. Brief symptom directed physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). Number of participants with clinically significant abnormal physical examination findings have been presented.|Up to 25 days|Safety population|||Participants|||Count of Participants
2536822|NCT03154086|Primary|Part A: Number of Participants With Abnormal Findings After Physical Examination in Cohort 3|A complete physical examination included, at a minimum, assessments of the skin, cardiovascular, respiratory, gastrointestinal and neurological systems. Brief symptom directed physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). Number of participants with clinically significant abnormal physical examination findings have been presented.|Up to 30 days in Cohort 3|Safety population|||Participants|||Count of Participants
2536823|NCT03154086|Primary|Part A: Number of Participants With Abnormal Findings After Physical Examination in Cohort 2|A complete physical examination included, at a minimum, assessments of the skin, cardiovascular, respiratory, gastrointestinal and neurological systems. Brief symptom directed physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). Number of participants with clinically significant abnormal physical examination findings have been presented.|Up to 30 days in Cohort 2|Safety population|||Participants|||Count of Participants
2536824|NCT03154086|Primary|Part A: Number of Participants With Abnormal Findings After Physical Examination in Cohort 1|A complete physical examination will include, at a minimum, assessments of the skin, cardiovascular, respiratory, gastrointestinal and neurological systems. Brief symptom directed physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). Number of participants with clinically significant abnormal physical examination findings have been presented.|Up to 64 days in Cohort 1|Safety population|||Participants|||Count of Participants
2536825|NCT03154086|Primary|Part B: Number of Participants With SAEs and Non-SAEs|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment.|Up to 25 days|Safety population|||Participants|||Count of Participants
2536944|NCT03150199|Other Pre-specified|Change in Pain-Related Disability|Measured by the Pain Disability Index (PDI), a well-validated measure of the extent to which pain interferes with different daily activities (Range 0-70). Higher scores indicate greater interference from pain.|Change in score from Baseline to 8 week, and Baseline to 16 week|Not all participants completed follow-up questionnaires at both follow-up time points.|||score on a scale||Standard Deviation|Mean
2536828|NCT03154086|Primary|Part A: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs in Cohort 1|An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other situations as per medical or scientific judgment.|Up to 64 days in Cohort 1|Safety Population comprised of all randomized participants who received at least one dose of study medication and was based on the actual treatment received, if this differed from that to which the participant was randomized.|||Participants|||Count of Participants
2536829|NCT03154047|Primary|Number of Participants With Adverse Events|AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome, or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|Each subject's study participation may have been up to 36 months or until the study was terminated|OLE Safety Population|||Participants|||Count of Participants
2536830|NCT03153956|Secondary|Short-Form 36 (SF-36) Total Score|The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The survey consists eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100, with lower scores = more disability and higher scores = less disability. Therefore, higher scores represent better health.|screening, 3 months, 6 months, 9 months, and 12 months|Participants who scheduled visits beyond 4 days before or after the specified timeframes (3, 6, and 9 months from screening) were not included in the analysis. (Treatment participants did not have a 9 month visit)|||score on a scale||Standard Deviation|Mean
2536831|NCT03153956|Secondary|Visual Analog Score (VAS) Score|The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.|12 Months|Data was not collected for this outcome measure due to study termination.||||||
2536832|NCT03153956|Primary|Western Ontario and McMaster University (WOMAC) Total Score|WOMAC evaluates the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. In this study, WOMAC scores were recomputed as the sum within sub-scales (pain score is the sum of questions 1-5; stiffness is the sum of questions 6-7; functional score is the sum of questions 8-24). The total score is reported as the sum of the pain, stiffness, and functional sub-scores for all participants. The total score range is 0-1292. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|screening, 3 months, 6 months, 9 months, and 12 months|Participants who scheduled visits beyond 4 days before or after the specified timeframes (3, 6, and 9 months from screening) were not included in the analysis. (Treatment participants did not have a 9 month visit)|||score on a scale||Standard Deviation|Mean
2536833|NCT03152591|Secondary|Change From Baseline in Free Androgen Index (FAI), at Day 15|Free Androgen Index (FAI) is a ratio used to determine abnormal androgen status in humans. The ratio is the total testosterone level divided by the sex hormone binding globulin (SHBG) level, and then multiplying by 100. FAI has no units.|Baseline, Day 15|Pharmacodynamic (PD) analysis set|||Ratio||90% Confidence Interval|Geometric Mean
2536834|NCT03152591|Secondary|Change From Baseline in Total Testosterone, at Day 15||Baseline, Day 15|Pharmacodynamic (PD) analysis set|||nmol/L||90% Confidence Interval|Geometric Mean
2536835|NCT03152591|Secondary|Change From Baseline in Dehydroepiandrostenedione Sulfate (DHEAS) at Day 15||Baseline, Day 15|Pharmacodynamic (PD) analysis set|||umol/L||90% Confidence Interval|Geometric Mean
2536836|NCT03152591|Secondary|Change From Baseline in Dehydroepiandrostenedione (DHEA) at Day 15||Baseline, Day 15|Pharmacodynamic (PD) analysis set|||nmol/L||90% Confidence Interval|Geometric Mean
2536837|NCT03152591|Secondary|Change From Baseline in Androstenedione at Day 15||Baseline, Day 15|Pharmacodynamic (PD) analysis set|||nmol/L||90% Confidence Interval|Geometric Mean
2536838|NCT03152591|Secondary|Change From Baseline in Sex Hormone Binding Globulin (SHBG) at Day 15||Baseline, Day 15|Pharmacodynamic (PD) analysis set|||nmol/L||90% Confidence Interval|Geometric Mean
2536839|NCT03152591|Secondary|Change From Baseline in Follicle Stimulating Hormone (FSH) at Day 15||Baseline, Day 15|Pharmacodynamic (PD) analysis set|||U/L||90% Confidence Interval|Geometric Mean
2536840|NCT03152591|Secondary|Change From Baseline in Luteinizing Hormone (LH) at Day 15||Baseline, Day 15|Pharmacodynamic (PD) analysis set|||U/L||90% Confidence Interval|Geometric Mean
2536841|NCT03152591|Primary|Change in Average Morning Fasting Free Testosterone Blood Concentrations From Baseline||Baseline, Day 15|Pharmacodynamic (PD) analysis set|||nmol/L||90% Confidence Interval|Geometric Mean
2536842|NCT03152552|Secondary|Change From Baseline in Bone Mineral Density (BMD) at Weeks 12 and 36|To evaluate bone mineral density as assessed by bone mineral content after 12 weeks and after 36 weeks of treatment. Only descriptive statistics were done.|Baseline, Week 12, Week 36|The Safety Set (SAF), which consisted of all patients who received at least one dose of double-blind study drug, was considered. The analysis included participants who participated in the DXA sub-study. Due to early termination of the study, only the data shown was available.|||grams (g)||Standard Deviation|Mean
2536843|NCT03152552|Secondary|24 Hour Urinary Phosphate Excretion at Weeks 12 and 36|Urinary phosphate excretion was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive statistics were done.|Baseline, Week 12, Week 36|The Safety Set (SAF), which consisted of all patients who received at least one dose of double-blind study drug, was considered. The analysis included patients who participated in the 24h urine collection sub-study. Due to early termination of the study, only the data shown was available.|||millimoles per day (mmol/d)||Standard Deviation|Mean
2536959|NCT03150199|Secondary|Utility of MI Component|Participants in the PP-MI group will provide ratings of utility after each MI exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises.|Weeks 1-8||||rating out of 10||Standard Deviation|Mean
2536844|NCT03152552|Secondary|Change From Baseline in 24 Hour Urinary Calcium Excretion at Weeks 12 and 36|Urinary calcium excretion was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive analysis done.|Baseline, Week 12, Week 36|Safety Set: All patients who received at least 1 dose of double-blind study drug & included patients who participated in sub-study. Due to early termination of study, only data shown was available. 'Overall Number of Participants Analyzed' = enrolled in 24h urine collection sub-study. 'Number Analyzed '= number of participants with data available|||millimoles per day (mmol/d)||Standard Deviation|Mean
2536845|NCT03152552|Secondary|Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 36|Evaluation of NT-proBNP was performed by a central laboratory. For Change from baseline, Geometric mean is the geometric mean of the endpoint to baseline ratio. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.|Baseline, Week 36|The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. LIK066 doses and placebo arms are considered per study objective. Due to early termination of the study, only the data shown was available.|||ratio||95% Confidence Interval|Geometric Mean
2536846|NCT03152552|Secondary|Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at Week 12 and 36|The change from BL in NYHA class at a given visit is a three-category ordinal variable (improved/unchanged/worsened) with the following definition: 1. Improved, if NYHA class decreases at least one level from BL; 2. Unchanged, if NYHA class is unchanged from BL; 3. Worsened, if NYHA class increases at least one level from BL. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.|Week 12, Week 36|The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. LIK066 doses and placebo arms were considered per study objective. Due to early termination of the study, only the data shown was available.|||Participants|||Count of Participants
2536847|NCT03152552|Secondary|Number of Participants With New York Heart Association (NYHA) Class I, II, II or IV|The NYHA Functional Classification classifies patients' heart failure according to the severity of their symptoms. The classification is as follows: Class I: no limitation of physical activity, ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath); Class II: slight limitation to physical activity, comfortable at rest, ordinary physical activity results in fatigue, palpitation or dyspnea; Class III: marked limitation of physical activity, comfortable at rest, less than ordinary activity causes fatigue, palpitation or dyspnea; Class IV: unable to carry on any physical activity without discomfort, symptoms of heart failure at rest, if any physical activity is undertaken, discomfort increases. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.|Baseline, Week 12, Week 36|The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. LIK066 doses and placebo arms were considered per study objective. Due to early termination of the study, only the data shown was available.|||Participants|||Count of Participants
2536848|NCT03152552|Secondary|Change From Baseline in Left Atrial Volume at Weeks 12 and 36|A limited two-dimensional and Doppler ECHO examination was performed to assess ECHO parameters. The images were sent to a central reading vendor for independent review and analysis.Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.|Baseline, Week 12, Week 36|The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. LIK066 doses and placebo arms were considered per study objective. Due to early termination of the study, only the data shown was available.|||milliliter (mL)||Standard Deviation|Mean
2536849|NCT03152552|Secondary|Change From Baseline in Left Atrial Size at Weeks 12 and 36|A limited two-dimensional and Doppler ECHO examination was performed to assess ECHO parameters. The images were sent to a central reading vendor for independent review and analysis. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.|Baseline, Week 12, Week 36|The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. LIK066 doses and placebo arms were considered per study objective. Due to early termination of the study, only the data shown was available.|||milliliter per square meter (mL/m^2)||Standard Deviation|Mean
2536850|NCT03152552|Secondary|Change From Baseline in 24 Hour Sodium Excretion at Weeks 12 and 36|Sodium excretion was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive statistics were done.|Baseline, Week 12, Week 36|FAS consisted of all randomized patients who were not mis-randomized. Due to early termination of the study, only the data shown was available. 'Overall Number of Participants Analyzed' = enrolled in the 24 hour urine collection sub-study. 'Number Analyzed' = number of participants with data available.|||millimoles per 24 hours (mmol/24h)||Standard Deviation|Mean
2536851|NCT03152552|Secondary|Change From Baseline in 24 Hour Urinary Glucose Excretion (UGE) at Weeks 12 and 36|UGE was measured from a 24h urine collection from about 25% of randomized patients and analyzed at a central laboratory. Only descriptive analysis done.|Baseline, Week 12, Week 36|FAS consisted of all randomized patients who were not mis-randomized. Due to early termination of the study, only the data shown was available. 'Overall Number of Participants Analyzed' = enrolled in the 24 hour urine collection sub-study. 'Number Analyzed' = number of participants with data available.|||millimoles per 24 hours (mmol/24h)||Standard Deviation|Mean
2536852|NCT03152552|Secondary|Change From Baseline in High Sensitive C-reactive Protein (hsCRP) at Weeks 12 and 36|hs-CRP is an inflammation biomarker. For Change from baseline, Geometric mean is the geometric mean of the endpoint to baseline ratio. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.|Baseline, Week 12, Week 36|The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. Due to early termination of the study, only the data shown was available.|||milligram per litre (mg/L)||95% Confidence Interval|Geometric Mean
2536878|NCT03152136|Other Pre-specified|Change in Bain & Findley Activities of Daily Living (ADL) Scale|"The complete Bain & Findley ADL questionnaire will be administered at baseline for all arms. For TAPS and sham arms, a subset of ADLs relevant to upper limb tremor will be repeated with provided props during and after stimulation.~On a weekly basis, all subjects will answer the complete Bain & Findley ADL questionnaire via phone call."|Collected before, during, and after in-office stimulation sessions at Week 0, Week 2, and Week 4. Collected via phone call Week 1 and Week 3.|||||||
2536853|NCT03152552|Secondary|Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Weeks 12 and 36|Total Cholesterol was measured on blood samples obtained after an overnight fast and analyzed at a central laboratory. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.|Baseline, Week 12, Week 36|FAS consisted of all randomized patients who were not mis-randomized. Analysis included patients who participated in the study. Due to early termination of the study, only the data shown was available. 'Overall Number of Participants Analyzed' = enrolled in the study. 'Number Analyzed' = number of participants with data available.|||Percent change||Standard Deviation|Mean
2536854|NCT03152552|Secondary|Change From Baseline in Fasting Lipid Profile (Lipoproteins) at Weeks 12 and 36|Lipoproteins (High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol) were measured on blood samples obtained after an overnight fast and analyzed at a central laboratory. Pre-planned statistical analysis were not performed for these secondary endpoints due to early study termination. Only descriptive statistics are presented.|Baseline, Week 12, Week 36|The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. Due to early termination of the study, only the data shown was available.|||Percent change||Standard Deviation|Mean
2536855|NCT03152552|Secondary|Change From Baseline in Fasting Lipid Profile (Triglycerides (TG)) at Weeks 12 and 36|TG was measured on blood samples obtained after an overnight fast and analyzed at a central laboratory. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.|Baseline, Week 12, Week 36|The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. Due to early termination of the study, only the data shown was available.|||Percent change||Standard Deviation|Mean
2536856|NCT03152552|Secondary|Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 12 and 36|Three sitting BP measurements were performed. At each visit, sitting BP was derived as the mean of three readings of the sitting SBP/DBP at that visit. Pre-planned statistical analyses were not performed for these secondary endpoints due to early study termination. Only descriptive statistics are presented.|Baseline, Week 12, Week 36|The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. Due to early termination of the study, only the data shown was available.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2536857|NCT03152552|Secondary|Change From Baseline in Body Composition Assessed by DXA (Total Body Water) at Weeks 12 and 36|A whole body DXA scan was performed to assess Total Body Water (Whole Body Minus Head Hologic, Whole Body Minus Head Lunar). DXA data were transferred to a central reading vendor for independent review and analysis. Only descriptive statistics done.|Baseline, Week 12, Week 36|FAS consisted of all randomized patients who were not mis-randomized. Analysis included patients who participated in the DXA sub-study. Due to early termination of the study, no data was collected.||||||
2536858|NCT03152552|Secondary|Change From Baseline in Body Composition Assessed by DXA (Lean Body Mass) at Weeks 12 and 36|A whole body DXA scan was performed to assess Lean Body Mass (Whole Body Minus Head Hologic, Whole Body Minus Head Lunar). DXA data were transferred to a central reading vendor for independent review and analysis. Only descriptive statistics done.|Baseline, Week 12, Week 36|The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. The analysis included patients who participated in the DXA sub-study. Due to early termination of the study, only the data shown was available.|||kilogram (kg)||Standard Deviation|Mean
2536859|NCT03152552|Secondary|Change From Baseline in Body Composition Assessed by DXA (Visceral Fat Mass) at Weeks 12 and 36|A whole body DXA scan was performed to assess Visceral Fat Mass (Whole Body Minus Head Hologic, Whole Body Minus Head Lunar). DXA data were transferred to a central reading vendor for independent review and analysis. Only descriptive statistics done.|Baseline, Week 12, Week 36|The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. The analysis included patients who participated in the DXA sub-study. Due to early termination of the study, no data was collected.||||||
2536860|NCT03152552|Secondary|Change From Baseline in Body Composition Assessed by DXA (Total Body Fat Mass) at Weeks 12 and 36|A whole body DXA scan was performed to assess Total Body Fat Mass (Whole Body Minus Head Hologic, Whole Body Minus Head Lunar). DXA data were transferred to a central reading vendor for independent review and analysis. Only descriptive statistics done.|Baseline, Week 12, Week 36|The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. The analysis included patients who participated in the DXA sub-study. Due to early termination of the study, only the data shown was available.|||kilogram (kg)||Standard Deviation|Mean
2536861|NCT03152552|Secondary|Change From Baseline in Body Composition Assessed by Bio-impedance (Lean Body Mass) at Weeks 12 and 36|Body composition was measured in all patients using bio-impedance, except in patients where it was contra-indicated, e.g. those using an implantable cardioverter-defibrillator. Body composition parameters were assessed as available for the different models of calibrated bio-impedance scales. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented|Baseline, Week 12, Week 36|The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized.|||Percentage of body fat mass||Standard Deviation|Mean
2536862|NCT03152552|Secondary|Change From Baseline in Body Composition Assessed by Bio-impedance (Visceral Fat Level) at Weeks 12 and 36|Body composition was measured in all patients using bio-impedance, except in patients where it was contra-indicated, e.g. those using an implantable cardioverter-defibrillator. Body composition parameters were assessed as available for the different models of calibrated bio-impedance scales. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented. Visceral fat levels were measured by Omron device. Levels ranged from 1 - 30 and are relative (not absolute) values. The Omron scale values are: 0 - 9 (normal), 10 - 14 (high) and 15 - 30 (very high). Visceral fat area ( 0 - approx. 300cm^2, 1 inch = 2.54 cm) distribution with 30 levels.|Baseline, Week 12, Week 36|The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized.|||Level||Standard Deviation|Mean
2536879|NCT03152136|Other Pre-specified|Clinical Global Impression of Improvement (CGI-I)|For TAPS and sham arms, the blinded rating neurologist will assess improvements in tremor level during and after stimulation.|Collected during and after in-office stimulation sessions at Week 0, Week 2, and Week 4|||||||
2536863|NCT03152552|Secondary|Change From Baseline in Body Composition Assessed by Bio-impedance (Total Body Fat Mass) at Weeks 12 and 36|Body composition was measured in all patients using bio-impedance, except in patients where it was contra-indicated, e.g. those using an implantable cardioverter-defibrillator. Body composition parameters were assessed as available for the different models of calibrated bio-impedance scales. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented|Baseline, Week 12, Week 36|The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized.|||Percentage of body fat mass||Standard Deviation|Mean
2536864|NCT03152552|Secondary|Change From Baseline in Body Weight at Weeks 12 and 36|Body weight was measured to the nearest 0.1 kg on a calibrated scale (weight and bio-impedance measurements), provided by the sponsor. Exceptionally (e.g. if the body weight exceeded the limits of the provided scale) sites were allowed to use another scale for weight measurement as available, but during the study the same scale was to be used for the same patient. The measurement was performed with the study patient in underwear and without shoes. Indoor clothing was also acceptable, but measurements were to be done consistently (either with underwear or with indoor clothing) throughout the study. Voiding before weight measurement was required. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.|Baseline, Week 12, Week 36|The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized.|||kilogram (kg)||Standard Deviation|Mean
2536865|NCT03152552|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 36|FPG was measured from a blood sample after an overnight fast; patients were not allowed to eat or drink anything (except water) for at least 8 h before each study visit. Samples were analyzed at a central laboratory. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.|Baseline, Week 12, Week 36|The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized.|||millimoles per litre (mmol/L)||Standard Deviation|Mean
2536866|NCT03152552|Secondary|Change From Baseline in Glycated Hemoglobin (HbA1c) at Weeks 12 and 36|HbA1c was measured from a blood sample and analyzed using a National Glycohemoglobin Standardization Program (NGSP) certified method at a central laboratory. Pre-planned statistical analysis was not performed for this secondary endpoint due to early study termination. Only descriptive statistics are presented.|Baseline, Week 12, Week 36|The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized.|||Percentage (%)||Standard Deviation|Mean
2536867|NCT03152552|Primary|Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 12|Evaluation of NT-proBNP was performed by a central laboratory. For Change from baseline, Geometric mean is the geometric mean of the endpoint to baseline ratio. Pre-planned statistical analysis was not performed for this primary endpoint due to early study termination. Only descriptive statistics are presented.|Baseline, Week 12|The Full Analysis Set (FAS) consisted of all randomized patients who were not mis-randomized. LIK066 doses and placebo arms are considered per study primary objective.|||ratio||95% Confidence Interval|Geometric Mean
2536868|NCT03152526|Secondary|The Secondary Endpoint is the Expansion and Persistence of NK Cells to be Used for the Remainder of the Study.|Successful expansion and persistence of NK cells is defined as ≥ 100 donor derived NK cells per µl blood.|Day+7 to Day+42 after NK cell infusion|As a result of poor subject accrual (n=1), statistically relevant efficacy data cannot be defined according to the protocol.||||||
2536869|NCT03152526|Primary|The Primary Endpoint of the Study is Complete Remission (±3 Days)|Both the number of patients with leukemia in complete remission and the number of patients with leukemia not in complete remission will be reported. Leukemia remission status will be assessed according to the Revised Recommendations of The International Working Group (J Clin Oncol 21:4642-4649, 2003).|On Day+42 (+/- 3 days) after NK cell infusion|As a result of poor subject accrual (n=1), statistically relevant efficacy data cannot be defined according to the protocol.||||||
2536870|NCT03152136|Other Pre-specified|Change in Clinical Rating Scale for Tremor (CRST) During Stimulation|A complete CRST examination (also known as the Fahn-Tolosa-Marin Tremor Rating Scale) will be completed at baseline for all arms: TAPS, sham, and 'no intervention.' For TAPS and sham arms, a subset of CRST relevant to upper limb tremor will be repeated during stimulation.|Collected before and during in-office stimulation sessions at Week 0, 2 and 4.|||||||
2536871|NCT03152136|Other Pre-specified|Change in Clinical Rating Scale for Tremor (CRST) After Stimulation|A complete CRST examination (also known as the Fahn-Tolosa-Marin Tremor Rating Scale) will be completed at baseline for all arms: TAPS, sham, and 'no intervention.' For TAPS and sham arms, a subset of CRST relevant to upper limb tremor will be repeated after stimulation.|Collected before and after in-office stimulation sessions at Week 0 and 4.|||||||
2536872|NCT03152136|Other Pre-specified|Device Usage Metrics|For TAPS and sham arms, the device will record usage metrics such as how many times the device was used per day and stimulation amplitude, to assess if there are any changes over time within group and within subject.|Week 4|||||||
2536873|NCT03152136|Other Pre-specified|Subject Survey of Satisfaction|At the final visit, all subject will take a subject satisfaction survey which will include questions such as likelihood to recommend and other questions related to the usability of the device.|Week 4|||||||
2536874|NCT03152136|Other Pre-specified|Patient Global Impression of Improvement (PGI-I)|For TAPS and sham arms, the blinded subject will assess improvements in their tremor level during and after stimulation during office visits.|Collected during and after in-office stimulation sessions at Week 0, Week 2, and Week 4|||||||
2536875|NCT03152136|Other Pre-specified|Change in Patient Global Impression of Severity (PGI-S)|"Tremor severity will be assessed with the 7-point PGI-S scale at baseline for all arms. For TAPS and sham arms, PGI-S will also be assessed during and after stimulation during office visits.~Additionally, for TAPS and sham arms, PGI-S will be entered on the device before and after each stimulation session in the home environment."|Before and after every stimulation session for TAPS and sham subjects through study completion. Twice daily for 'no intervention' subjects through study completion.|||||||
2536876|NCT03152136|Other Pre-specified|Change in Quality of Life in Essential Tremor Questionnaire (QUEST)|The QUEST assessment will be administered to all subjects during in-office visits (every 2 weeks).|Week 0, 2, and 4|||||||
2536877|NCT03152136|Other Pre-specified|Subject Impression of Durability of Effect|TAPS and sham arms will also be asked how long their tremor relief lasts due to stimulation, if applicable.|Week 1, 2, 3 and 4.|||||||
2536882|NCT03152136|Primary|Percent Change in Tremor Power|For TAPS and sham arms, subjects will be prompted to perform a lateral postural hold prior to entering their PGI-S score before and after each stimulation session. During this hold, the device will record motion data to objectively assess if there are any changes in tremor level.|Mean tremor power pre stimulation over two weeks of device usage as compared to mean tremor power post stimulation over two weeks of device usage.||||percent tremor improvement||Standard Deviation|Mean
2536883|NCT03151551|Secondary|Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS)|The C-SSRS is a scale that captures the occurrence, severity, and frequency of suicide-related ideations and behaviors during the assessment period.|Baseline, Week 52||2020-08-31|08/2020||||
2536884|NCT03151551|Secondary|Change From Baseline on the Treatment Satisfaction Questionnaire|The Treatment Satisfaction Questionnaire is a clinician-administered questionnaire which provides an assessment of the participant's opinion of the effectiveness, safety, and overall satisfaction of the study medication.|Baseline, Week 52||2020-08-31|08/2020||||
2536885|NCT03151551|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score|DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment.|Baseline, Week 52||2020-08-31|08/2020||||
2536886|NCT03151551|Secondary|Change From Baseline in Measures of Health Utility (EuroQol-5 Dimensions 5 Level [EQ-5D 5L])|The EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a VAS. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.|Baseline, Week 52||2020-08-31|08/2020||||
2536887|NCT03151551|Secondary|Change From Baseline in SF-36: Mental Component Summary (MCS)|SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well-being.|Baseline, Week 52||2020-08-31|08/2020||||
2536888|NCT03151551|Secondary|Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS)|SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well-being.|Baseline, Week 52||2020-08-31|08/2020||||
2536889|NCT03151551|Secondary|Change From Baseline in Fatigue Severity NRS (Fatigue NRS) Score|"The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing no fatigue and 10 representing as bad as you can imagine. Participants rate their fatigue (weariness, tiredness) by circling the 1 number that described their worst level of fatigue during the past 24 hours."|Baseline, Week 52||2020-08-31|08/2020||||
2536890|NCT03151551|Secondary|Change From Baseline in the Itch NRS|"The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participant's itching from psoriasis is indicated by circling the number that best described the worst level of itching in the past 24 hours."|Baseline, Week 52||2020-08-31|08/2020||||
2536891|NCT03151551|Secondary|Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Fingernails Score in the Subgroup of Participants With Fingernail Involvement at Baseline|The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis).|Baseline, Week 52||2020-08-31|08/2020||||
2536892|NCT03151551|Secondary|Change From Baseline in Psoriasis Body Surface Area (BSA)|The investigator evaluates the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb.|Baseline, Week 52||2020-08-31|08/2020||||
2536893|NCT03151551|Secondary|Change From Baseline in the Leeds Dactylitis Index-Basic (LDI-B) in Participants With Dactylitis at Baseline|The LDI-B measures the severity of dactylitis. In each digit, the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot measured in mm. Each dactylitic digit is defined by a minimum increase of 10% in circumference over the contra-lateral digit.|Baseline, Week 52||2020-08-31|08/2020||||
2536894|NCT03151551|Secondary|Change From Baseline in the Leeds Enthesitis Index (LEI) in Participants With Enthesitis at Baseline|The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle of humerus, right/left (R/L); medial femoral condyle,(R/L); Achilles tendon insertion, (R/L)).|Baseline, Week 52||2020-08-31|08/2020||||
2536895|NCT03151551|Secondary|Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index in Participants With Enthesitis at Baseline|The SPARCC enthesitis index evaluates tenderness in a total of 16 entheseal sites: the greater trochanter (right/left [R/L]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial epicondyles of humerus (R/L),Lateral epicondyle humerus (R/L) and the supraspinatus insertion (R/L).|Baseline, Week 52||2020-08-31|08/2020||||
2536896|NCT03151551|Secondary|Change From Baseline in Modified Composite Psoriatic Disease Activity Index (CPDAI) Score (Modified)|The CPDAI is a validated instrument intended to assess composite psoriatic disease activity and response to therapy. Domains include peripheral arthritis as assessed by the number of tender and swollen joints and the HAQ-DI, skin as assessed by the PASI and the Dermatology Life Quality Index (DLQI), enthesitis as assessed by the number of sites with enthesitis and the HAQ-DI, and dactylitis as assessed by the number of digits affected.|Baseline, Week 52||2020-08-31|08/2020||||
2536897|NCT03151551|Secondary|Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)|The PsARC is a composite criteria reported in terms of the percentage of participants achieving response according to the following criterion: TJC, SJC, PGA, and PatGA. Overall response is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: at least 30% reduction in TJC, at least 30% reduction in SJC, at least a 20 millimeter (mm) reduction in PGA and at least a 20 mm reduction in PatGA.|Week 52||2020-08-31|08/2020||||
2536899|NCT03151551|Secondary|Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)|The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in milligrams per liter), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees.|Baseline, Week 52||2020-08-31|08/2020||||
2536900|NCT03151551|Secondary|Percentage of Participants Simultaneously Achieving ACR50 and PASI100|Proportion of participants simultaneously achieving ACR50 and PASI100 will be derived from the number of participants who have achieved PASI100 and achieved ACR50 divided by the total number of participants.|Week 52||2020-08-31|08/2020||||
2536901|NCT03151551|Secondary|Change From Baseline in HAQ-DI|HAQ-DI is a participant reported questionnaire that measures disease-associated disability (physical function). It consists of 24 questions with 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities. The disability section scores the participant's self-perception on the degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), covering the 8 domains. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability.|Baseline, Week 52||2020-08-31|08/2020||||
2536902|NCT03151551|Secondary|Change From Baseline in C-Reactive Protein (CRP)|CRP is the ACR Core Set laboratory measure of acute-phase reactant.|Baseline, Week 52||2020-08-31|08/2020||||
2536903|NCT03151551|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity|The investigator, who must be a physician, is asked to give an overall assessment of the severity of the participant's current PsA activity using a horizontal VAS.|Baseline, Week 52||2020-08-31|08/2020||||
2536904|NCT03151551|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity|The participant's overall assessment of his or her PsA activity is recorded using a horizontal VAS.|Baseline, Week 52||2020-08-31|08/2020||||
2536905|NCT03151551|Secondary|Change From Baseline in Participant's Assessment of Pain VAS|"Participants are asked to assess his/her current level of arthritis pain by marking a vertical tick on a horizontal VAS with the left end marked as no pain and the right end marked worst possible pain."|Baseline, Week 52||2020-08-31|08/2020||||
2536906|NCT03151551|Secondary|Change From Baseline in SJC|SJC is determined by examination of 66 joint counts that are classified as either swollen or not swollen. Swelling is defined as palpable fluctuating synovitis of the joint.|Baseline, Week 52||2020-08-31|08/2020||||
2536907|NCT03151551|Secondary|Change From Baseline in TJC|TJC is determined by examination of 68 joint counts that are assessed for tenderness by pressure and joint manipulation on physical examination.|Baseline, Week 52||2020-08-31|08/2020||||
2536908|NCT03151551|Secondary|Percentage of Participants Achieving PASI100|PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Participants achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Any participants with active plaque psoriasis (PsO) with a BSA ≥3% and PASI = 0 at baseline were considered PASI100 responders if & only if they had achieved PASI=0 & BSA=0 at week 24.|Week 24|All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.|||percentage of participants||95% Confidence Interval|Number
2536909|NCT03151551|Secondary|Percentage of Participants Achieving ACR50|ACR50 response is defined as a ≥50% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of joint pain Visual Analog Scale (VAS), Participant's Global Assessment of Disease Activity (PatGA) VAS, Physician's Global Assessment of Disease Activity (PGA) VAS, participant's assessment of physical function using the Health Assessment Questionnaire-Disability Index (HAQ-DI), or High Sensitivity (assay) C-Reactive Protein (hs-CRP).|Week 24|All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.|||percentage of participants||95% Confidence Interval|Number
2536910|NCT03151551|Primary|Percentage of Participants Simultaneously Achieving American College of Rheumatology 50 (ACR50) and Psoriasis Area and Severity Index 100 (PASI100)|ACR50 response is a ≥50% improvement from baseline for tender joint count(TJC)& swollen joint count (SJC)& in at least 3 of the following 5 criteria: Participant's(pts) assessment of joint pain Visual Analog Scale (VAS),Pts Global Assessment of Disease Activity (PatGA)VAS, Physician's Global Assessment of Disease Activity (PGA)VAS, Pts assessment of physical function using the Health Assessment Questionnaire-Disability Index(HAQ-DI), or High Sensitivity(assay)C-Reactive Protein (hs-CRP). PASI is an index combining assessments of the extent of body-surface involvement in head, trunk, arms, legs, and severity of desquamation, erythema and plaque thickness in each region, yielding overall score of 0-no involvement, to 72-most severe involvement. Pts achieving PASI100 were defined as having 100% improvement in the PASI score compared to baseline. Pts with active plaque PsO with a BSA≥3% & PASI=0 at baseline were considered PASI100 responders if they had achieved PASI=0 & BSA=0 at week 24.|Week 24|All participants who received at least one dose of study drug. Per protocol and statistical analysis plan, the primary and secondary analysis were performed to compare all ixekizumab participants together versus all adalimumab participants together.|||percentage of participants||95% Confidence Interval|Number
2536911|NCT03151265|Secondary|Observation of Self-reported Changes in Functional Status Pre- and Post- ThermaCare Application as Measured by the Roland Morris Disability Questionnaire (RMDQ) if Subjects Scored >3 on the NRS|Measurement of disability related to low back pain. A checklist of 24 items. A score of 24 indicates maximum disability.|Change from Baseline after 1 consecutive day.|RMDQ scores were not captured for the sports group as 'no pain/disability' is a selection criterion for this group.|||score on a scale||Standard Error|Mean
2538417|NCT03100058|Secondary|Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion|Evaluation of 24-hour urinary calcium after 48 weeks of treatment|Baseline, Week 24, Week 48|Full Analysis Set|||mmol/24hr||Standard Deviation|Mean
2536912|NCT03151265|Secondary|Impression of Change From Subjects Post Intervention and/or Assessment Period Using the Patient Global Impression of Change Scale (PGIC).|"Measurement of perceived change in Low back pain. Score from a scale of 1-7. 1 indicates no change (or condition has worsened), 7 indicates a considerable improvement.~The results depicted indicate the change in PGIC scores between Day 1 and Day 2 (intervention)"|Change from Baseline after 1 consecutive day.|PGIC data were not collected for the Active in Sport Group, as subjects in this group were selected on the basis that they had no pain. As such, they would not have had an applicable impression of change related to pain.|||score on a scale||Standard Error|Mean
2536913|NCT03151265|Secondary|Observation of Self-reported Changes in Functional Status Pre- and Post- ThermaCare Application as Measured by the Oswestry Disability Index (ODI) if Subjects Scored >3 on the NRS|"Measurement of disability related to low back pain. Contains 10 sections, each of which can be from from 0-5 for a maximum score of 50.~50 indicates maximum possible disability (bed-bound - or are exaggerating their symptoms).~The results depicted indicate the change in NRS scores between baseline and post-intervention"|Change from Baseline after 1 consecutive day.|ODI scores were not captured for the sports group as 'no pain/disability' is a selection criterion for this group.|||score on a scale||Standard Error|Mean
2536914|NCT03151265|Secondary|Change in Pain From Baseline|"Pain Score out of 10 as measured on a Numeric Rating scale (NRS)~Score from 0-10 where 10 indicates maximum pain, and 0 indicates no pain.~The results depicted indicate the change in NRS scores between baseline and post-intervention"|Change from Baseline after 1 consecutive day.|Pain scores were not captured for the sports group as 'no pain' is a selection criterion for this group.|||scale on a scale||Standard Error|Mean
2536915|NCT03151265|Secondary|A Change in Muscle Activity From Baseline in Subjects Where Abnormal EMG Activity During Baseline is Detected.|Surface EMG measurement of erector spinae muscle activity at L3 vertebra level|Change from Baseline after 1 consecutive day.||||Ratio||Standard Deviation|Mean
2536916|NCT03151265|Secondary|In Group 1 (LBP Patients), a Change in Maximum Pain During Movement Score, for Any One Plane of Movement.|Pain Score out of 10 as rated on the ViMove scale during movement assessment. Score from 0-10 where 10 indicates maximum pain, and 0 indicates no pain. The results depicted indicate the change in pain scores between baseline and post-intervention|Change from Baseline after 1 consecutive day.|Pain scores were not captured for the sports group as 'no pain' is a selection criterion for this group.|||score on a scale||Standard Error|Mean
2536917|NCT03151265|Secondary|A Change Over Time in Range of Motion in Any One Plane of Movement Compared to Pre-intervention Range of Motion.|Maximal range of low back movement in sagittal,axial and coronal planes. Results depict the change in Pelvis ROM in the sagittal plane.|Change from Baseline after 1 consecutive day.||||Degrees||Standard Deviation|Mean
2536918|NCT03151265|Primary|Change in Erector Spinae Muscle Activity Over Time|"Collection of erector spinae muscle activity data from all participants. The results provided depict the mean muscle-activity difference between the day 1 and day 2 PM sessions.~Surface Electromyography (sEMG) sensors are adhered utilizing a height-specific sensor placement template. Placement is parallel with the L3 vertebrae.~Evaluated in the form of the flexion-relaxation response. When performing a forward flexion movement, muscle activation occurs at the commencement of the movement (when bending down;concentric), as well as during the return to the upright position (eccentric). At maximum flexion, minimal muscle activation is expected (i.e. muscle relaxation). However, in subjects with Low-back pain, muscle relaxation is often absent.~As such, the following formula is used to evaluate the flexion-relaxation response.~Sum of sEMG activity at maximum flexion divided by the summed sEMG activity of both concentric and eccentric muscle activation."|Change from Baseline Erector spinae muscle activity data after 1 consecutive day.||||Ratio||Standard Deviation|Mean
2536919|NCT03151265|Primary|Change in Movement Data Over Time|Collection of movement data from all participants. The results listed here depict the average change in Trunk Range of Motion (ROM) between day 1 and day 2 PM sessions|Change from Baseline movement data after 1 consecutive day.||||Degrees||Standard Deviation|Mean
2536920|NCT03151226|Primary|Respiratory Depression/Suppression|defined by values obtained utilizing capnography and pulse oximetry|up to 24 hours|the 2 subjects who wore device did not wear the device enough to be evaluable data||||||
2536921|NCT03150758|Primary|Maximum Cavernosal Nerve Stimulation Threshold|"Median value of maximum stimulation pattern men received prior to erection in responders"|Up to 21 days after prostatectomy|Participants who responded to therapy|||mA||Inter-Quartile Range|Median
2536922|NCT03150719|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)||Day 1 up to Day 84|Safety set.|||Participants|||Count of Participants
2536923|NCT03150719|Secondary|Tolerability as Assessed by Number of Participants Who Discontinued Treatment||Day 1 through Day 56|Safety set.|||Participants|||Count of Participants
2536924|NCT03150719|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Average of Day 28 and Day 56 Measurements|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Day 28 and Day 56|FAS.|||units on a scale||Standard Deviation|Mean
2536925|NCT03150719|Secondary|Relative Change From Baseline in ppFEV1 at Average of Day 28 and Day 56 Measurements|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Day 28 and Day 56|FAS.|||percent change||Standard Deviation|Mean
2536926|NCT03150719|Secondary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Day 28 and Day 56 Measurements|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Day 28 and Day 56|Full analysis set (FAS) included all randomized participants who carried the intended cystic fibrosis transmembrane conductance regulator gene (CFTR) allele mutation and had received at least 1 dose of study drug.|||percent predicted of FEV1||Standard Deviation|Mean
2536927|NCT03150719|Primary|Incidence of Respiratory Adverse Events of Special Interest (RAESIs)|RAESIs included chest discomfort, dyspnea (shortness of breath), respiration abnormal (chest tightness), asthma, bronchial hyperreactivity, bronchospasm, and wheezing.|Day 1 up to Day 84|Safety set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2536928|NCT03150485|Secondary|Subject's Responses to Individual Item 10|"Subjects responses to individual item Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Opinion Of These Contact Lenses?. This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
2536929|NCT03150485|Secondary|Subject's Responses to Individual Item 9|"Subjects responses to individual item How would you rate your overall visual performance with the study contact lens?. This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
2536930|NCT03150485|Secondary|Subject's Responses to Individual Item 8|"Subjects responses to individual item Considering your experience with the study contact lens, how excited are you about this lens being available to purchase?. This item had a response set of Very Excited, Excited, Unsure, Unexcited and Very Unexcited. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
2536931|NCT03150485|Secondary|Subject's Responses to Individual Item 7|"Subjects responses to individual item Study Compare To Your Current Vision Correction Solutions?. This item had a response set of Much better, somewhat better, about the same, somewhat worse and much worse. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
2536932|NCT03150485|Secondary|Subject's Responses to Individual Item 6|"Subjects responses to individual item What Are Your Current Vision Correction Solutions?. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
2536933|NCT03150485|Secondary|Subject's Responses to Individual Item 5|"Subjects responses to individual item If You Were To Purchase The Study Contact Lenses, With What Frequency Would You Expect To Wear Them?. This item had a response set of All of the time, Usually, Frequently, Sometimes, Rarely and never. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
2536934|NCT03150485|Secondary|Subject's Responses to Individual Item 4|"Subjects responses to individual item Where Would You Expect To Go Looking For Information About This Contact Lens? Please Select All That Apply.. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
2536935|NCT03150485|Secondary|Subject's Responses to Individual Item 3|"Subjects responses to individual item Please Think About Your Experience Today With The Study Contact Lenses. Please Indicate How You Satisfied You Are With The Overall Contact Lens Fitting Process?. This item had a response set of very satisfied, satisfied, unsure, dissatisfied and very dissatisfied. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
2536936|NCT03150485|Secondary|Subject's Responses to Individual Item 2|"Subjects responses to individual item Based On Your Experience Today, How Likely Are You To Purchase This Contact Lens?. This item had a response set of extremely likely, very likely, somewhat likely, slightly likely and not at all likely. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
2536937|NCT03150485|Secondary|Subject's Responses to Individual Item 1|"Subjects responses to individual item Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Satisfaction Of These Contact Lenses?. This item had a response set of extremely satisfied, very satisfied, moderately satisfied, slightly satisfied and not at all satisfied. The percentage of subject's in each response category was reported."|15 Minuted Post Lens Insertion|All subjects that completed the study without a major protocol deviation.|||percentage of participants|||Number
2536938|NCT03150485|Primary|The Average Number of Fitting Modifications to Optimize Vision|The eye care practitioner (ECP) followed the fitting guides to assess the vision provided by the study lenses and determined if a lens change (modification) was needed. The ECP modified the lenses based upon the subject's responses in accordance with the fitting guide. Up to two modifications per subject was allowed. The number of modifications required by the ECP to optimize vision was reported.|15 minutes post lens insertion|Subjects that completed all study visits without a major protocol deviation.|||Lens|Eyes|Standard Deviation|Mean
2536939|NCT03150199|Other Pre-specified|Change in Hemoglobin A1c|Measured during in-person visit at baseline and post-intervention|Change from Baseline to 8 week|Not all participants attended the follow-up visit at Week 8.|||mg/dL||Standard Deviation|Mean
2536940|NCT03150199|Other Pre-specified|Change in Blood Pressure (Diastolic)|Measured during in-person visit at baseline and post-intervention|Change from Baseline to 8 week|Not all participants attended the follow-up visit at Week 8.|||millimeters of mercury||Standard Deviation|Mean
2536941|NCT03150199|Other Pre-specified|Change in Blood Pressure (Systolic)|Measured during in-person visit at baseline and post-intervention.|Change from Baseline to 8 week|Not all participants attended the follow-up visit at Week 8.|||millimeters of mercury||Standard Deviation|Mean
2536942|NCT03150199|Other Pre-specified|Change in Body Mass Index (BMI)|Measured during in-person visit at baseline and post-intervention.|Baseline and 8 weeks|Not all participants attended the follow-up visit at Week 8, and not all of those participants who did had their weight taken.|||kg/m^2||Standard Deviation|Mean
2536943|NCT03150199|Other Pre-specified|Change in Weight|Measured during in-person visit at baseline and post-intervention.|Change from Baseline to 8 week|Not all participants attended the follow-up visit at Week 8, and not all of those participants who did had their weight taken.|||pounds||Standard Deviation|Mean
2537588|NCT03128723|Secondary|Cutaneous Tolerance Scores: Dryness/Scaling|Cutaneous Tolerance Scores: Dryness/Scaling (assessing skin dryness), from Baseline to Day 14. Scale range is 0-3, where 0 = no dryness, 1 = mild dryness, 2 = moderate dryness, and 3 = severe dryness.|Baseline to Day 14||||Units on a scale||Standard Deviation|Mean
2536945|NCT03150199|Other Pre-specified|Change in Physical Function|Measured by the 20-item short form of the Patient-Reported Outcomes Measurement Information System (PROMIS), a well-validated measure of physical function that is highly responsive to changes in a patient's physical function status (Range: 20-100). Higher scores indicate better physical function.|Change in score from Baseline to 8 week, and Baseline to 16 week|Not all participants completed follow-up questionnaires at both follow-up time points.|||score on a scale||Standard Deviation|Mean
2536946|NCT03150199|Other Pre-specified|Change in Self-reported Physical Activity|Measured by the self-report International Physical Activity Questionnaire (IPAQ). The measure assesses the types of intensity of physical activity that people do as part of their daily lives. All activities are converted to multiples of resting energy expenditure (MET) minutes per week. Change was calculated by subtracting the score at baseline from the score at 8 and 16 weeks.|Change from Baseline to 8 week, and Baseline to 16 week|Not all participants completed all follow-up questionnaires at both follow-up time points.|||MET minutes per week||Standard Deviation|Mean
2536947|NCT03150199|Other Pre-specified|Change in Medication Adherence|Measured by Self-Reported Medication Adherence (SRMA), a two-item self-report medication adherence scale measuring percentage of time (in 10% increments) patients report taking their heart medications in the past one and two weeks. Minimum: 0, Maximum:100. Change was calculated by subtracting the score at baseline from the score at 8 weeks and 16 weeks. Higher scores indicate greater levels of medication adherence.|Change in score from Baseline to 8 week, and Baseline to 16 week|Not all participants completed follow-up questionnaires at both follow-up time points.|||percentage||Standard Deviation|Mean
2536948|NCT03150199|Secondary|Change in Diabetes Self-Care|Measured by the Summary of Diabetes Self-Care Activities (SDSCA), a well-validated measure of diabetes self-management that is associated with clinical outcomes (Range: 0-7). Higher scores indicate more diabetes self-care activities.|Change in score from Baseline to 8 week, and Baseline to 16 week|Not all participants completed all follow-up questionnaires at both follow-up time points.|||score on a scale||Standard Deviation|Mean
2536949|NCT03150199|Secondary|Change in Perceived Social Support|Measured by the Multidimensional Scale of Perceived Social Support (MSPSS), a scale that measures subjectively reported social support (Range: 12-84). Higher scores indicate more subjectively reported social support.|Change in score from Baseline to 8 week, and Baseline to 16 week|Not all participants completed follow-up questionnaires at both follow-up time points.|||score on a scale||Standard Deviation|Mean
2536950|NCT03150199|Secondary|Change in Resilience|Measured by the Brief Resilience Scale (BRS), a reliable scale which assesses a person's ability to recover from stress despite adversity (Range: 6-30). Higher scores indicate more resilience.|Change in score from Baseline to 8 week, and Baseline to 16 week|Not all participants completed follow-up questionnaires at both follow-up time points.|||score on a scale||Standard Deviation|Mean
2536951|NCT03150199|Secondary|Change in Anxiety|The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale was be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 8 and 16 weeks. Higher scores indicate higher levels of anxiety.|Change in score from Baseline to 8 week, and Baseline to 16 week|Not all participants completed follow-up questionnaires at both follow-up time points.|||score on a scale||Standard Deviation|Mean
2536952|NCT03150199|Secondary|Change in Depression|The Hospital Anxiety and Depression Scale (HADS)-depression subscale was be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 8 and 16 weeks. Higher scores indicate higher levels of depression.|Change in score from Baseline to 8 week, and Baseline to 16 week|Not all participants completed follow-up questionnaires at both follow-up time points.|||score on a scale||Standard Deviation|Mean
2536953|NCT03150199|Secondary|Change in Self-Efficacy for Exercise|Measured by the Self-Efficacy for Exercise scale (SEE), a validated scale which assess self-efficacy barriers to exercise (Range: 0-90). Higher scores indicate higher efficacy expectations in relation to exercising. This was measured at Baseline, Week 8, and Week 16.|Change in score from Baseline to 8 week, and Baseline to 16 week|Not all participants completed follow-up questionnaires at both follow-up time points.|||score on a scale||Standard Error|Mean
2536954|NCT03150199|Secondary|Change in Optimism|Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Change was calculated by subtracting the score at baseline from the score at 8 and 16 weeks. Higher scores indicate higher levels of optimism.|Change in score from Baseline to 8 week, and Baseline to 16 week|Not all participants completed follow-up questionnaires at both follow-up time points.|||score on a scale||Standard Deviation|Mean
2536955|NCT03150199|Secondary|Change in Positive Affect|The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 8 and 16 weeks. Higher scores indicate higher levels of positive affect.|Change in score from Baseline to 8 week, and Baseline to 16 week|Not all participants completed follow-up questionnaires at both follow-up time points.|||score on a scale||Standard Deviation|Mean
2536956|NCT03150199|Secondary|Change in Sedentary Time|Measured by Actigraph accelerometer, in minutes per day.|Change from Baseline to 8 week, and Baseline to 16 week|Not all participants wore the Actigraph and provided adequate data.|||minutes/day||Standard Deviation|Mean
2536957|NCT03150199|Secondary|Change in Physical Activity|Measured by Actigraph accelerometer, in number of steps per day.|Change from Baseline to 8 week, and Baseline to 16 week|Not all participants wore the Actigraph and provided adequate data.|||steps/day||Standard Deviation|Mean
2536958|NCT03150199|Secondary|Change in Moderate-Vigorous Physical Activity|ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at 8 weeks, and another week at 16 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity.|Change from Baseline to 8 week, and Baseline to 16 week|Not all participants wore the Actigraph and provided adequate data at both follow-up time points.|||minutes/day||Standard Deviation|Mean
2536960|NCT03150199|Secondary|Utility of PP Component|Participants in the PP-MI group will provide ratings of utility after each PP exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises.|Weeks 1-8||||units on a scale||Standard Deviation|Mean
2536961|NCT03150199|Secondary|Ease of MI Component|Participants in the PP-MI group will provide ratings of ease after each MI exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises.|Weeks 1-8||||units on a scale||Standard Deviation|Mean
2536962|NCT03150199|Secondary|Ease of PP Component|Participants in the PP-MI group will provide ratings of ease after each PP exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises.|Weeks 1-8||||units on a scale||Standard Deviation|Mean
2536963|NCT03150199|Primary|Number of PP-MI Sessions Completed by Participants|Measured by number of PP-MI sessions completed by participants in the PP-MI group.|8 weeks||||sessions completed||Standard Deviation|Mean
2536964|NCT03150160|Secondary|Percentage Change From Baseline in IOP for Each Time Point at Week 6|IOP was measured by Goldmann applanation tonometry in mmHg. A more negative percent change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.|Baseline, Week 6|At the time of the premature termination of this study, only 1 patient was randomized. Therefore, the planned efficacy and safety analyses could not be performed. No data to report.||||||
2536965|NCT03150160|Secondary|Mean Change From Baseline in IOP for Each Time Point at Week 6|IOP was measured by Goldmann applanation tonometry in mmHg. A more negative change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.|Baseline (9:00 am and 11:00 am), Week 6 (9:00 am and 11:00 am)|At the time of the premature termination of this study, only 1 patient was randomized. Therefore, the planned efficacy and safety analyses could not be performed. No data to report.||||||
2536966|NCT03150160|Secondary|Mean Diurnal IOP at Week 6|IOP was measured by Goldmann applanation tonometry in mmHg. Diurnal IOP was defined as the average of the 9:00 and 11:00 time points. One (study eye) contributed to the analysis.|Week 6|At the time of the premature termination of this study, only 1 patient was randomized. Therefore, the planned efficacy and safety analyses could not be performed. No data to report.||||||
2536967|NCT03150160|Secondary|Percent Change From Baseline in IOP at Week 6|IOP was measured by Goldmann applanation tonometry in mmHg. A more negative percent change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.|Baseline, Week 6|At the time of the premature termination of this study, only 1 patient was randomized. Therefore, the planned efficacy and safety analyses could not be performed. No data to report.||||||
2536968|NCT03150160|Primary|Mean Change From Baseline in Diurnal IOP at Week 6|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry in millimeters mercury (mmHg). Diurnal IOP was defined as the average of the 9:00 am and 11:00 am time points. A more negative change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.|Baseline, Week 6|At the time of the premature termination of this study, only 1 patient was randomized. Therefore, the planned efficacy and safety analyses could not be performed. No data to report.||||||
2536969|NCT03150108|Secondary|Number of Participants Who Reported Positive to Anti-Parathyroid Hormone Antibodies|Number of participants who reported positive to anti-parathyroid hormone antibodies were reported.|Non-Hispanic Caucasians: 30 min pre-dose,32 days post-dose Japanese Descents: 30 min pre-dose on Days 1,4,7 and 32 days after last dose|The safety set included enrolled participants who received at least 1 dose of rhPTH(1-84).|||Participants|||Count of Participants
2536970|NCT03150108|Secondary|Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Results Reported as Treatment-emergent Adverse Events (TEAEs)|Twelve-lead ECGs were performed in triplicate at each time point. For numeric ECG variables, the mean of the valid values at each time point was taken. Number of participants with clinically significant changes in ECGs reported as TEAEs were reported.|Non-Hispanic Caucasians: 30 min pre-dose,24 h,32 days post-dose Japanese Descents: 30 min pre-dose,24 h post-dose on Days 1,4,7 and 32 days after last dose|The safety set included enrolled participants who received at least 1 dose of rhPTH(1-84).|||Participants|||Count of Participants
2536971|NCT03150108|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs Reported as Treatment-emergent Adverse Events (TEAEs)|Vital signs were obtained while participant was supine. Vital signs included hematology, chemistry, and urinalysis. Number of participants with clinically significant changes in vital signs reported as TEAEs were reported.|Non-Hispanic Caucasians: 30 min pre-dose,1,4,8,24 h,32 days post-dose Japanese Descents: 30 min pre-dose,1,4,8,24 h post-dose on Days 1,4,7 and 32 days after last dose|The safety set included enrolled participants who received at least 1 dose of rhPTH(1-84).|||Participants|||Count of Participants
2536972|NCT03150108|Secondary|Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests Reported as Treatment-emergent Adverse Events (TEAEs)|Clinical laboratory tests included hematology, chemistry, and urinalysis. Number of participants with clinically significant changes in clinical laboratory tests reported as TEAEs were reported.|Non-Hispanic Caucasians: 30 min pre-dose,24 h,32 days post-dose Japanese Descents: 30 min pre-dose,24 h post-dose on Days 1,4,7 and 32 days after last dose|The safety set included enrolled participants who received at least 1 dose of rhPTH(1-84).|||Participants|||Count of Participants
2536973|NCT03150108|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.|From start of study drug administration to follow-up (up to 40 days)|The safety set included enrolled participants who received at least 1 dose of rhPTH(1-84).|||Participants|||Count of Participants
2536985|NCT03150108|Primary|Baseline-adjusted AUC(0-inf) of PTH(1-84) in Plasma|Baseline-adjusted area under the concentration versus time curve extrapolated to infinity (AUC(0-inf)) of PTH(1-84) was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).|30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose|The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value. Here number of participants analyzed indicates the participants evaluable for this outcome.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2536974|NCT03150108|Secondary|Emax of PTH(1-84) on Albumin-corrected Calcium, Serum Total Calcium and Serum Phosphate Levels|The maximum effect (Emax) of PTH(1-84) on albumin-corrected calcium, serum total calcium and serum phosphate levels were reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).|Non-Hispanic Caucasians: 30 mins predose, 4, 8 and 12 h (Day 1),24 h (Day 2) Japanese Descents: 30 mins predose, 4, 8 and 12 h (Days 1, 4, 7), 24 h (Days 2, 5, 8)|The PD set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PD concentration value.|||millimoles per liter (mmol/L)||Geometric Coefficient of Variation|Geometric Mean
2536975|NCT03150108|Secondary|TEmax After Intake of PTH(1-84) on Albumin-corrected Calcium, Serum Total Calcium and Serum Phosphate Levels|The time to maximum effect (TEmax) of PTH(1-84) on albumin-corrected calcium, serum total calcium and serum phosphate levels were reported.|Non-Hispanic Caucasians: 30 mins predose, 4, 8 and 12 h (Day 1),24 h (Day 2) Japanese Descents: 30 mins predose, 4, 8 and 12 h (Days 1, 4, 7), 24 h (Days 2, 5, 8)|The PD set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PD concentration value.|||Hour (h)||Full Range|Median
2536976|NCT03150108|Secondary|AUClast of Albumin-corrected Calcium, Serum Total Calcium and Phosphate Levels After Intake of PTH(1-84)|Area under the curve from the time of dosing to the last measurable concentration of albumin-corrected calcium, serum total calcium and phosphate levels after intake of PTH(1-84) was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).|Non-Hispanic Caucasians: 30 mins predose, 4, 8 and 12 h (Day 1),24 h (Day 2) Japanese Descents: 30 mins predose, 4, 8 and 12 h (Days 1, 4, 7), 24 h (Days 2, 5, 8)|The pharmacodynamic (PD) set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PD concentration value.|||Hours * millimoles per liter (h×mmol/L)||Geometric Coefficient of Variation|Geometric Mean
2536977|NCT03150108|Secondary|Original AUClast of PTH(1-84) in Plasma|Original area under the curve from the time of dosing to the last measurable concentration (AUClast) of PTH(1-84) was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).|30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose|The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2536978|NCT03150108|Secondary|Original Tmax of PTH(1-84)|The original time to reach maximum observed drug concentration (Tmax) of PTH(1-84) in plasma was reported.|30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose|The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value.|||Hour (h)||Full Range|Median
2536979|NCT03150108|Secondary|Original Cmax of PTH(1-84) in Plasma|Original maximum observed drug concentration (Cmax) of PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).|30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose|The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2536980|NCT03150108|Primary|Baseline-adjusted Vdz/F of PTH(1-84) in Plasma|Baseline-adjusted apparent volume of distribution (Vdz/F) of PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).|30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose|The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value. Here number of participants analyzed indicates the participants evaluable for this outcome.|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
2536981|NCT03150108|Primary|Baseline-adjusted CL/F of PTH(1-84) in Plasma|Baseline-adjusted apparent clearance (CL/F) of PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).|30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose|The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value. Here number of participants analyzed indicates the participants evaluable for this outcome.|||Liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2536982|NCT03150108|Primary|Baseline-adjusted t1/2 of PTH(1-84) in Plasma|Baseline-adjusted Terminal Half-life (t1/2) of PTH(1-84) in plasma was reported.|30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose|The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value. Here number of participants analyzed indicates the participants evaluable for this outcome.|||Hour (h)||Full Range|Median
2536983|NCT03150108|Primary|Baseline-adjusted Lambda_z of PTH(1-84) in Plasma|Baseline-adjusted Lambda z associated with the terminal (log-linear) portion of the curve for PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).|30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose|The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value.|||Per hour (1/h)||Geometric Coefficient of Variation|Geometric Mean
2536984|NCT03150108|Primary|Baseline- Adjusted % of AUC(0-Inf) Extra of PTH(1-84) in Plasma|Baseline-adjusted % of AUC extrapolated from the last measurable concentration to infinity over (AUC(0-Inf)) of PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).|30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose|The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value. Here number of participants analyzed indicates the participants evaluable for this outcome.|||Percentage of AUC||Geometric Coefficient of Variation|Geometric Mean
2536986|NCT03150108|Primary|Baseline-adjusted AUC(0-8) of PTH(1-84) in Plasma|Baseline-adjusted area under the concentration versus time curve from the time of dosing to 8 hours post dose (AUC(0-8)) of PTH(1-84) was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).|30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose|The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2536987|NCT03150108|Primary|Baseline-adjusted AUC(Last) of PTH(1-84) in Plasma|Baseline-adjusted area under the curve from the time of dosing to the last measurable concentration (AUC(last)) of PTH(1-84) was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).|30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose|The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value.|||Hour*picogram per milliliter (h*pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2536988|NCT03150108|Primary|Baseline-adjusted Tmax of PTH(1-84)|Baseline-adjusted time to reach maximum observed drug concentration (Tmax) of PTH(1-84) in plasma was reported.|30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose|The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value.|||Hour (h)||Full Range|Median
2536989|NCT03150108|Primary|Baseline-adjusted Cmax of PTH(1-84)|Baseline-adjusted maximum observed drug concentration (Cmax) of PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).|30 and 90 minutes (min) Pre-dose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours (h) Post-dose|The pharmacokinetic (PK) set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value.|||Picogram per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2536990|NCT03150082|Secondary|Body Temperature at Indicated Time-points|Body temperature of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 2 of each treatment period|Safety Population|||Degree Celsius||Standard Deviation|Mean
2536991|NCT03150082|Secondary|Pulse Rate at Indicated Time-points|Pulse rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 2 of each treatment period|Safety Population|||Beats per minute||Standard Deviation|Mean
2536992|NCT03150082|Secondary|Respiratory Rate at Indicated Time-points|Respiratory rate of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 2 of each treatment period|Safety Population|||Breaths per minute||Standard Deviation|Mean
2536993|NCT03150082|Secondary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points|Blood pressure of participants was measured on Day 1 and Day 2 of each treatment period 1 and 2 in a supine position after 5 minutes rest. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 2 of each treatment period|Safety Population|||Millimeters of mercury||Standard Deviation|Mean
2536994|NCT03150082|Secondary|Number of Participants With Clinically Significant Abnormal Findings for Electrocardiogram (ECG) Parameters|A single 12-lead ECGs was obtained on Day 1 and Day 2 of each treatment period 1 and 2 using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT corrected (QTc) intervals. The number of participants with abnormal (clinically significant) findings for ECG parameters have been presented.|Up to Day 2 of each treatment period|Safety Population|||Participants|||Number
2536995|NCT03150082|Secondary|Number of Participants With Clinically Significant Abnormal Findings for Urinalysis|Urine samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2. The number of participants with abnormal (clinically significant) findings for urinalysis have been presented.|Up to Day 2 of each treatment period|Safety Population|||Participants|||Number
2536996|NCT03150082|Secondary|Erythrocyte Count at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of erythrocyte count. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 2 of each treatment period|Safety Population|||10^12 cells per liter||Standard Deviation|Mean
2536997|NCT03150082|Secondary|Hematocrit at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematocrit. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 2 of each treatment period|Safety Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
2536998|NCT03150082|Secondary|Percent Reticulocytes at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of percent reticulocytes. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 2 of each treatment period|Safety Population|||Percentage of reticulocytes||Standard Deviation|Mean
2536999|NCT03150082|Secondary|Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including MCHC and Hb. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 2 of each treatment period|Safety Population|||Grams per deciliter||Standard Deviation|Mean
2537000|NCT03150082|Secondary|Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCH. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 2 of each treatment period|Safety Population|||Picogram||Standard Deviation|Mean
2537001|NCT03150082|Secondary|Mean Corpuscular Volume (MCV) at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of MCV. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 2 of each treatment period|Safety Population|||Femtoliter||Standard Deviation|Mean
2538418|NCT03100058|Secondary|Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion|Evaluation of 24-hour urinary calcium excretion after 24 week of treatment.|Baseline, Week 24|Full Analysis Set|||mmol/24hr||Standard Deviation|Mean
2537002|NCT03150082|Secondary|Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for evaluation of hematology parameters including platelets, neutrophils, monocytes, lymphocytes, leucocyte, eosinophils and basophils. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 2 of each treatment period|Safety Population|||10^9 cells per liter||Standard Deviation|Mean
2537003|NCT03150082|Secondary|Total Protein at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of total Protein. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 2 of each treatment period|Safety Population|||Grams per liter||Standard Deviation|Mean
2537004|NCT03150082|Secondary|Total Bilirubin (Total Bil), Direct Bilirubin (Direct Bil) and Creatinine (Creat) at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including total bil, direct bil and creat. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 2 of each treatment period|Safety Population|||Moles per liter||Standard Deviation|Mean
2537005|NCT03150082|Secondary|Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including calcium, chloride, glucose, magnesium, potassium and sodium. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 2 of each treatment period|Safety Population|||Millimoles per liter||Standard Deviation|Mean
2537006|NCT03150082|Secondary|Blood Urea Nitrogen (BUN) at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of BUN. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 2 of each treatment period|Safety Population|||Milligrams per deciliter||Standard Deviation|Mean
2537007|NCT03150082|Secondary|Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk Phos), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LD) at Indicated Time-points|Blood samples were collected from participants on Day -1 and Day 2 of each treatment period 1 and 2 for the analysis of clinical chemistry parameters including ALT, Alk phos, AST and LD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 2 of each treatment period|Safety Population|||Units per liter||Standard Deviation|Mean
2537008|NCT03150082|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Non-serious AEs (Non-SAEs)|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations. The analysis was performed on Safety Population which comprised of all randomized participants who received at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.|Up to 4 weeks in each treatment period|Safety Population|||Participants|||Number
2537009|NCT03150082|Secondary|Terminal Phase Half-life (t1/2) for Ciprofloxacin|Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods.|Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period|Pharmacokinetic Population|||Hours||Geometric Coefficient of Variation|Geometric Mean
2537010|NCT03150082|Secondary|Percentage of AUC (0-infinity) Obtained by Extrapolation (Percentage AUCex) for Ciprofloxacin|Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods.|Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period|Pharmacokinetic Population|||Percentage of AUCex||Geometric Coefficient of Variation|Geometric Mean
2537011|NCT03150082|Secondary|Time of Occurrence of Cmax (Tmax) for Ciprofloxacin|Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Tmax of ciprofloxacin was analyzed using a nonparametric test to compute point estimate of the median and full range.|Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period|Pharmacokinetic Population|||Hours||Full Range|Median
2537012|NCT03150082|Secondary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) for Ciprofloxacin|Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods.|Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period|Pharmacokinetic Population|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2537034|NCT03149848|Secondary|Assessment of Hematology Parameter: Eryrocyte Mean Corpuscular Hemoglobin|Blood samples for hematology assessment was collected for Eryrocyte Mean Corpuscular Hemoglobin. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)|Safety Population.|||Picograms||Standard Deviation|Mean
2537013|NCT03150082|Primary|Maximum Observed Plasma Concentration (Cmax) of Ciprofloxacin|Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods.|Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period|Pharmacokinetic Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2537014|NCT03150082|Primary|Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments (AUC[0-t]) for Ciprofloxacin|Blood samples were collected from participants at indicated time points in each of the treatment period 1 and 2, after administration of study treatment to investigate the pharmacokinetics of ciprofloxacin under fasted state. Pharmacokinetic analysis of ciprofloxacin was conducted using non-compartmental methods. Pharmacokinetic Population comprised of participants who completed the study and for whom primary pharmacokinetic parameters could be calculated for all treatment periods were included in the statistical pharmacokinetic analysis of the study.|Pre-dose and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 3.50, 4.50, 6.00, 8.00, 12.00, 18.00 hours post-dose on Day 1; 24.00 hours post-dose on Day 2 in each treatment period|Pharmacokinetic Population|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2537015|NCT03149887|Secondary|Oral Analgesic Requirements on Postoperative Day 3|Patients reported the number of oral analgesic tablets (5 mg oxycodone tablets) ingested on postoperative day 3. This is expressed as Oral Morphine Equivalents in mg.|Postoperative Day 3|These 51 patients underwent the injection, were assessed for the primary outcome, and completed the questionnaire related to the pain, analgesic and side effects for first three postoperative days (secondary outcomes). Three patients did not fill out this questionnaire and therefore are not included in the reports of secondary outcomes.|||Oral morphine equivalents in mg||Standard Deviation|Mean
2537016|NCT03149887|Secondary|Oral Analgesic Requirements on Postoperative Day 2|Amount of oral opioids (oxycodone 5 mg tablets) ingested by patients on Postoperative Day 2, expressed as Oral Morphine Equivalents in mg.|Postoperative day 2|These 51 patients underwent the injection, were assessed for the primary outcome, and completed the questionnaire related to the pain, analgesic and side effects for first three postoperative days (secondary outcomes). Three patients did not fill out this questionnaire and therefore are not included in the reports of secondary outcomes.|||Oral morphine equivalents in mg||Standard Deviation|Mean
2537017|NCT03149887|Secondary|Oral Analgesic Requirements on Postoperative Day 1|Oral analgesic dose (5 mg oxycodone tablets) required expressed as oral morphine equivalents. Outcome is total oral opioid used on postoperative day 1 expressed as oral morphine equivalents in mg.|Postoperative day 1|These 51 patients underwent the injection, were assessed for the primary outcome, and completed the questionnaire related to the pain, analgesic and side effects for first three postoperative days (secondary outcomes). Three patients did not fill out this questionnaire and therefore are not included in the reports of secondary outcomes.|||Oral morphine equivalents in mg||Standard Deviation|Mean
2537018|NCT03149887|Secondary|Mean NRS Pain Score With Motion|NRS Pain score with passive motion (for those patients who performed this), on 0-10 scale, with zero being no pain and 10 representing severe pain. Outcome score is mean of reported pain scores for passive motion episodes on all three postoperative days.|Mean value of reported pain scores on postoperative days 1,2 and 3|These 51 patients underwent the injection, were assessed for the primary outcome, and completed the questionnaire related to the pain, analgesic and side effects for first three postoperative days (secondary outcomes). Three patients did not fill out this questionnaire and therefore are not included in the reports of secondary outcomes.|||Score on a scale||Standard Deviation|Mean
2537019|NCT03149887|Secondary|Mean NRS Pain Scores at Rest on Postoperative Day 3|Patients recorded their pain scores at rest with ingestion of each oral analgesic table on postoperative day 3. Zero implies no pain, whereas 10 implies very severe pain. Outcome score is mean of reported pain scores for this day.|Postoperative Day 3|These 51 patients underwent the injection, were assessed for the primary outcome, and completed the questionnaire related to the pain, analgesic and side effects for first three postoperative days (secondary outcomes). Three patients did not fill out this questionnaire and therefore are not included in the reports of secondary outcomes.|||score on a scale||Standard Deviation|Mean
2537020|NCT03149887|Secondary|Mean NRS Pain Score at Rest on Postoperative Day 2|Mean of patient-reported NRS pain scores on postoperative day 2. Patients recorded pain scores at rest with each oral analgesic tablet taken. Zero implies no pain, whereas a score of 10 translates to very severe pain. Outcome score is mean of reported pain scores for this day.|Postoperative day 2|These 51 patients underwent the injection, were assessed for the primary outcome, and completed the questionnaire related to the pain, analgesic and side effects for first three postoperative days (secondary outcomes). Three patients did not fill out this questionnaire and therefore are not included in the reports of secondary outcomes.|||score on a scale||Standard Deviation|Mean
2537021|NCT03149887|Secondary|Mean NRS Pain Score at Rest on Postoperative Day 1|Mean NRS pain score on scale of 1-10, at rest (zero is no pain, 10 is severe pain). Patients recorded their pain score at rest with administration of each oral analgesic tablet. Outcome score is mean of reported pain scores for this day.|Postoperative day 1|These 51 patients underwent the injection, were assessed for the primary outcome, and completed the questionnaire related to the pain, analgesic and side effects for first three postoperative days (secondary outcomes). Three patients did not fill out this questionnaire and therefore are not included in the reports of secondary outcomes.|||Score on a scale||Standard Deviation|Mean
2537022|NCT03149887|Primary|Numeric Rating Pain Score [NRS] at Time of Block Resolution|"Numeric rating score pain level at time of nerve block resolution, on scale of 0-10, as reported by patient at time of 24 hour follow up phone call. A reported score of zero implies no pain, whereas a score of 10 implies very severe pain. Outcome score is mean of reported pain scores by participants at time of nerve block resolution."|At the time of block resolution, as reported by patients at follow up phone call||||Score on a scale||Standard Deviation|Mean
2537161|NCT03141372|Secondary|Number of Participants Satisfied or Very Satisfied With Void Trial Using 5 Point Lickert Scale|Participant satisfaction level with the method of void trial will be collected at the 10-14 day post-operative visit and compared between the two methods of void trial.|at 10-14 days post-surgery||||Participants|||Count of Participants
2537023|NCT03149848|Secondary|Change From Baseline in Pulse Rate|Vital signs measurement was done in semi-supine position after 10 minutes rest and included pulse rate. Two pulse rate measurement were taken at pre-dose on Day 1, at least 1 minute apart. The mean value recorded at pre-dose was classified as Baseline. Single pulse rate was obtained at all other time points during the study. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline to follow-up (10 to 14 days after last dose)|Safety Population.|||Beats/minute||Standard Deviation|Mean
2537024|NCT03149848|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital signs measurement was done in semi-supine position after 10 minutes rest and included SBP and DBP. Two blood pressure measurement were taken at pre-dose on Day 1, at least 1 minute apart. The mean value recorded at pre-dose was classified as Baseline. Single blood pressure was obtained at all other time points during the study. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline to follow-up (10 to 14 days after last dose)|Safety Population.|||Millimeters of Mercury||Standard Deviation|Mean
2537025|NCT03149848|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|ECG measurements was performed with the participant in a semi-supine position having rested in this position for at least 10 minutes beforehand. Data has been presented for Period 1, Day 14 pre-dose which showed abnormal- not clinically significant ECG finding. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day 1, 14, 21, 28 and follow-up (10 to 14 days after last dose)|Safety Population.|||Participants|||Count of Participants
2537026|NCT03149848|Secondary|Number of Participants With Abnormal Urinalysis Result|Samples for urinalysis assessment was collected at Day -1, Day 13, Day 21, Day 27 and during follow-up period (10 to 14 daya after last dose). Data for participants with abnormal urinalysis results has been presented.|Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)|Safety Population.|||Participants|||Count of Participants
2537027|NCT03149848|Secondary|Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea|Samples for clinical chemistry assessment were collected for Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium and Urea. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)|Safety Population.|||Millimoles per Liter||Standard Deviation|Mean
2537028|NCT03149848|Secondary|Assessment of Clinical Chemistry Parameters: Direct Bilirubin (DB), Bilirubin and Creatinine|Samples for clinical chemistry assessment were collected for DB, bilirubin and creatinine. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)|Safety Population.|||Micromoles per Liter||Standard Deviation|Mean
2537029|NCT03149848|Secondary|Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT)|Samples for clinical chemistry assessment were collected for ALP, AST, ALT, CK and GGT. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)|Safety Population.|||International units per Liter||Standard Deviation|Mean
2537030|NCT03149848|Secondary|Assessment of Clinical Chemistry Parameters: Albumin and Protein|Samples for clinical chemistry assessment were collected for Albumin and Protein. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)|Safety Population.|||Grams per Liter||Standard Deviation|Mean
2537031|NCT03149848|Secondary|Assessment of Hematology Parameters: Erythrocytes Distribution Width (EDW)|Blood samples for hematology assessment was collected for EDW. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)|Safety Population.|||Percentage of EDW||Standard Deviation|Mean
2537032|NCT03149848|Secondary|Assessment of Hematology Parameters: Erythrocytes and Reticulocytes|Blood samples for hematology assessment were collected for Erythrocytes and reticulocytes. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)|Safety Population.|||10^12 cells/Liter||Standard Deviation|Mean
2537033|NCT03149848|Secondary|Assessment of Hematology Parameter: Erythrocye Mean Corpuscular Volume|Blood samples for hematology assessment was collected for Erythrocyte Mean Corpuscular Volume. NA indicated data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)|Safety Population.|||Femtoliters||Standard Deviation|Mean
2537035|NCT03149848|Secondary|Assessment of Hematology Parameter: Hemoglobin|Blood samples for hematology assessment was collected for Hemoglobin. NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)|Safety Population.|||Grams per Liter||Standard Deviation|Mean
2537036|NCT03149848|Secondary|Assessment of Hematology Parameters: Hematocrit and Reticulocytes/Erythrocytes (R/E)|Blood samples for hematology assessment were collected for Hematocrit and R/E. NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)|Safety Population.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2537037|NCT03149848|Secondary|Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes|Blood samples for hematology assessment were collected for basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. NA indicate data not available since only one participant was analyzed, therefore standard deviation was not derived. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day -1, Day 13, Day 21, Day 27 and follow-up (10 to 14 days after last dose)|Safety Population.|||10^9 cells/Liter||Standard Deviation|Mean
2537038|NCT03149848|Secondary|Concurrent Medication Assessment in Treatment Period 1 and 2|Concurrent medications included paracetamol and ibuprofen. Number of participants who took concurrent medications during the study are presented.|Up to 10 weeks|Safety Population.|||Participants|||Count of Participants
2537039|NCT03149848|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect and associated with liver injury and impaired liver function. Safety Population comprised of all participants who enrolled in the study and received at least one dose of study drug.|Up to 10 weeks|Safety Population.|||Participants|||Count of Participants
2537040|NCT03149848|Secondary|Assessment of Plasma CAB PK Parameter: The Apparent Oral Clearance (CL/F)|Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. CL/F was calculated as CL/F =Dose/AUC(0 to tau).|Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28|PK Summary Population|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2537041|NCT03149848|Secondary|Assessment of Plasma CAB PK Parameter: Terminal Phase Half-life (t1/2)|Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. Apparent terminal half-life was calculated as: t1/2 = ln2 / Lambda_z, where Lambda_z is the terminal phase rate constant. Plasma t1/2 was not estimated for either period due to limited PK sampling in the terminal phase.|Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28|PK Summary Population. Plasma t1/2 was not estimated for either period due to limited PK sampling in the terminal phase.||||||
2537042|NCT03149848|Secondary|Assessment of Plasma CAB PK Parameter: Time of Occurrence of Cmax (Tmax)|Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. Tmax was determined directly from the concentration-time data.|Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28|PK Summary Population|||Hours||Full Range|Median
2537043|NCT03149848|Secondary|Assessment of Plasma CAB PK Parameter: Concentration at the End of the Dosing Interval (Ctau)|Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. Comparisons were made for the repeated dose PK parameters of CAB when given alone in Period 1 and when co-administered with steady-state RBT in Period 2.|Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28|PK Summary Population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2537044|NCT03149848|Primary|Assessment of Plasma CAB PK Parameter: Maximum Observed Concentration (Cmax)|Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. Cmax was determined directly from the concentration-time data. Comparisons were made for the repeated dose PK parameters of CAB when given alone in Period 1 and when co-administered with steady-state RBT in Period 2.|Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28|PK Summary Population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2537055|NCT03148756|Secondary|Number of Participants With Day 84 Mortality in the Safety Population|Day 84 mortality was measured by the number of deaths up to Day 84.|Day 84|Safety Population included all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.|||Participants|||Count of Participants
2537118|NCT03143166|Primary|Maximum Concentration of Total Dabigatran in Plasma (Cmax).|This outcome is maximum measured concentration of the total dabigatran in plasma|Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose.|PKS|||Nano gram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2537045|NCT03149848|Primary|Assessment of Plasma CAB Pharmacokinetic (PK) Parameter: Area Under the Concentration-time Curve Over One Dosing Interval (AUC [0 to Tau])|Blood samples for PK analysis of CAB were collected at pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28. AUC (0 to tau) was calculated using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. PK Summary Population included participants who had CAB PK parameter estimates from both serial PK sampling time periods 1 and 2. Comparisons were made for the repeated dose PK parameters of CAB when given alone in Period 1 and when co-administered with steady-state RBT in Period 2.|Pre-dose (within 15 minutes prior to dose) on Days 13 and 14; and 1, 2, 3, 4, 8, 12, and 24 hours post-dose on Day 14, pre-dose (within 15 minutes prior to dose) on Days 26, 27 and 28; and 1, 2, 3, 4, 8, 12 and 24 hours post-dose on Day 28|PK Summary Population|||Microgram * hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2537046|NCT03148756|Secondary|Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the CE Population|Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.|Day 84|CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit.|||percentage of participants|||Number
2537047|NCT03148756|Secondary|Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the CE Population|Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.|Day 42|CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit.|||percentage of participants|||Number
2537048|NCT03148756|Secondary|Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the ITT Population|Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.|Day 84|ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.|||percentage of participants|||Number
2537049|NCT03148756|Secondary|Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the ITT Population|Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.|Day 42|ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.|||percentage of participants|||Number
2537050|NCT03148756|Secondary|Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population|Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.|Day 84|CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit.|||percentage of participants|||Number
2537051|NCT03148756|Secondary|Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population|Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.|Day 42|CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit.|||percentage of participants|||Number
2537052|NCT03148756|Secondary|Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population|Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.|Day 84|ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.|||percentage of participants|||Number
2537053|NCT03148756|Secondary|Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population|Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.|Day 42|ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.|||percentage of participants|||Number
2537054|NCT03148756|Secondary|Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population|Clinical outcome was either success or failure/relapse. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.|Day 84|CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit.|||percentage of participants|||Number
2537056|NCT03148756|Secondary|Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population|Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.|Day 42|CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit.|||percentage of participants|||Number
2537057|NCT03148756|Secondary|Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population|Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.|Day 42|ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.|||percentage of participants|||Number
2537058|NCT03148756|Primary|Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population|Clinical response was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. Failure was defined as: ongoing signs and symptoms considered by the investigator to be related to complicated bacteremia or IE requiring additional antibacterial therapy or unplanned valve replacement, recurrent bacteremia, death during the study period up to Day 84 or discontinuation of the study medication due to an adverse event.|Day 84|ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.|||Participants|||Count of Participants
2537059|NCT03148691|Primary|Mean of Per Subject Percentages of Target Lesions Judged to be Clear (PWA=0) at Visit 8|"Mean of per subject percentages of target lesions judged to be clear (PWA=0) at Visit 8~Grade Descriptor~0 Clear: no visible seborrheic keratosis lesion~Near Clear: a visible seborrheic keratosis lesion with a surface appearance different from the surrounding skin (not elevated)~Thin: a visible seborrheic keratosis lesion (thickness ≤ 1 mm)~Thick: a visible seborrheic keratosis lesion (thickness > 1 mm)"|Day 106||||Per-Subject Percent of Lesions Clear|Lesions|Standard Deviation|Mean
2537060|NCT03148470|Secondary|Nonverbal Switching|Nonverbal Switching: response times|Within 30 minutes after intervention|Data are compared between iTBS and cTBS Sham-TBS is only used to have a baseline control between the two groups|||Milliseconds||Standard Deviation|Mean
2537061|NCT03148470|Primary|RTs for Picture Naming With the Factors Language (L1, L2) and Block (Switching, Non-Switching)|"Picture naming with the factors Language (L1, L2) and Block (Switching, Non-Switching): Speech onset times (msec) L1 refers to the mother tongue. L2 refers to the late acquired (> age 7) second language. Switching Block refers to a language switching block with picture naming alternated between the mother tongue and the second language.~Non-Switching Block refers to a block of picture naming either only in the mother or only in the second language."|Within 30 minutes after intervention|As a primary outcome we compared RTs following iTBS vs cTBS. Sham-TBS is only used to have a baseline control between the two groups|||Milliseconds||Standard Deviation|Mean
2537062|NCT03148262|Primary|The Number of Desaturation Episodes|The number of desaturation episodes defined as blood oxygen saturation (SpO2) below 90% during the perioperative period during colonoscopy.|Perioperative period during colonoscopy||||Episodes||Inter-Quartile Range|Median
2537063|NCT03148236|Secondary|Post Procedural Pain|Sum of pain scores every six hours for the 24 hour period following ablation measured on a visual analog scale scored on a level from zero (no pain) to 10 (maximum pain)|baseline to 24 hours||||score on a scale||Inter-Quartile Range|Median
2537064|NCT03148236|Primary|Change in Von Willebrand Factor (vWF)|Biomarker of blood vessel damage|baseline to 30 days||||micrograms/mL||Inter-Quartile Range|Median
2537065|NCT03148236|Primary|Change in Interleukin (IL-6)|Biomarker of inflammation|baseline to 30 days||||pg/mL||Inter-Quartile Range|Median
2537066|NCT03148236|Primary|Change in hsCRP|Biomarker of inflammation|baseline to 30 days||||mg/L||Inter-Quartile Range|Median
2537067|NCT03148236|Primary|Change in Plasma Ascorbic Acid Level|Change in plasma ascorbic acid level|Baseline to 30 days||||micromolar||Inter-Quartile Range|Median
2537068|NCT03148236|Primary|Change in Creatinine Levels|Change in kidney function|Baseline to 30 days||||mg/dL||Inter-Quartile Range|Median
2537069|NCT03148236|Primary|Change in Von Willebrand Factor (vWF)|Biomarker of blood vessel damage|baseline to 24 hours||||micrograms/mL||Inter-Quartile Range|Median
2537070|NCT03148236|Primary|Change in Interleukin (IL-6)|Biomarker of inflammation|baseline to 24 hours||||pg/mL||Inter-Quartile Range|Median
2537071|NCT03148236|Primary|Change in hsCRP|Biomarker of inflammation|baseline to 24 hours||||mg/L||Inter-Quartile Range|Median
2537072|NCT03148236|Primary|Change in Plasma Levels of Ascorbic Acid|Change in plasma levels of ascorbic acid|baseline to 24 hours||||micromolar||Inter-Quartile Range|Median
2537073|NCT03148236|Primary|Change in Creatinine Levels|Change in Kidney Function|Baseline to 24 hours||||mg/dL||Inter-Quartile Range|Median
2537098|NCT03144518|Secondary|Secretory IgA Response|Secretory IgA levels measured in saliva samples via ELISA. This is a non-specific measure of immunological response|Baseline, Immediately Post Intervention (i.e, 15 minutes post-baseline).|Missing Data Count n=15|||Flow Rate (ug/min)||Standard Deviation|Mean
2537099|NCT03144518|Secondary|Attrition|Attrition - to inform a future definitive trial|4 weeks (post-vaccination), 16 Weeks (post-vaccination)||||Participants|||Count of Participants
2537100|NCT03144518|Secondary|Recruitment|Recruitment rates to inform a future definitive trial|Baseline|Total Population that received study Invitation|||Participants|||Count of Participants
2537159|NCT03141528|Secondary|Assessment of the Participants BLS Competences After Test|"Assessment of the participant's BLS competence by the study team after test.~Rated on a Visual Analogue Scale from 0-100mm, where 0mm = completely incompetent, no idea what to do, and 100mm = totally competent, cannot be done better."|after first BLS course and 3 months later||||units on a scale||Inter-Quartile Range|Median
2537074|NCT03148067|Secondary|Possible Risk Factors Related to Occurrence of SSI After Intramedullary Nailing|Patient-related factors: age; gender; body mass index; duration of preoperative hospitalization; infection in other foci; presence of immunosuppressive conditions; physical status classification according to ASA; occurrences of multiple trauma and ISS score; injury etiology; exposure time (for open fractures); AO fracture classification; soft-tissue injury classification; Gustilo-Anderson open fracture classification; stay at other hospital before transference; use of external fixation; previous surgical manipulation and use of blood products. Factors relating to the surgery: wound classification according to potential for contamination; surgery length; hair removal; antibiotic prophylaxis or therapy; use of drains; patient temperature and oxygenation; type of nail used (anterograde or retrograde); reaming; primary closure; necessity for a skin-muscle flap and use of negative-pressure wound therapy. Microbiota-related factors: evaluation of colonization by S. aureus and A. baumannii.|one year after surgery|Previous use of external fixations (OR 2.53) and need for soft tissue reconstruction (OR 10.94) were associated to surgical site infections after intramedular nailing|||odds ratio||95% Confidence Interval|Number
2537075|NCT03148067|Primary|Incidence of Surgical Site Infection (SSI) Relating to Intramedullary Nailing for Fixation of Diaphyseal Femoral and Tibial Fractures|Patients who present signs of infection in the region of the surgery under evaluation or who describe alterations compatible with SSI, or whose records mention signs or symptoms compatible with the definitions of SSI, are considered to be cases with evolution to infection. Patients included in the study who, during routine or emergency care present a condition (according to the researchers' evaluation) suggestive of a SSI associated with intramedullary nailing are considered to be cases of infection|one year after surgery|221 patients included in the study completed the planned follow up period. In total, 26 cases of infection were observed, with an incidence of 11.8%.|||Participants|||Count of Participants
2537076|NCT03147248|Secondary|Mean Actual Value in Serum CRP Concentration (Pharmacodynamic Parameter) (Part 2)|"For evaluation of pharmacodynamic (PD), the secondary endpoint was defined as concentration of CRP between 2 treatment groups up to Week 54. The blood samples for CRP were collected at Weeks 0, 2 and 6, and every 8 weeks up to Week 54.~Patient who received the other treatment than that to which they were assigned at any point was defined as mis-randomized. One patient in IV group was mis-randomized and analyzed as SC group for PD analysis."|Baseline, Week 2, Week 6, Week 14, Week 22, Week 30, Week 38, Week 46, and Week 54|The PD population consisted of all randomized population who received at least 1 full dose of study drug at Week 6 or thereafter and had at least 1 PD result (rheumatoid factor, anti-cyclic citrullinated peptide, CRP or ESR) after Week 6 treatment. All patients in PD population were analyzed according to the treatment they received.|||mg/dL||Standard Deviation|Mean
2537077|NCT03147248|Secondary|Observed Trough Serum Concentration (Ctrough) of Infliximab (Part 2)|For evaluation of pharmacokinetics (PK), the secondary endpoint was defined as the analysis of trough concentration (concentration before the next study drug administration) of Infliximab up to Week 54. The samples were collected at Weeks 0, 2 and 6, and every 8 weeks up to Week 54. During PK monitoring visit (Weeks 22-30), samples were collected every 2 weeks according steady state PK sampling time point. All patients were randomly assigned at Week 14 in a 1:1:1:1 ratio to one of 4 groups (Groups A, B, C or D) for PK monitoring visit period. No PK results were obtained at Weeks 6 and 14 for SC group and Weeks 12, 20, 24, 26 and 28 for IV group due to 2 weeks and 8 weeks dosing interval, respectively.|SC group: Weeks 0, 2, 12, 20, 22, 24, 26, 28, 36, 44, and 52; IV group: Weeks 0, 2, 6, 14, 22, 36, 44, and 52|The PK population consisted of all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 IV, CT-P13 SC) at Week 6 or thereafter and who had at least 1 PK concentration result after Week 6 or thereafter treatment. All patients in PK population were analyzed according to the treatment they received.|||μg/mL||Standard Deviation|Mean
2537078|NCT03147248|Secondary|Number of Patients Achieving Clinical Response According to American College of Rheumatology 20% Response (ACR20) (Part 2)|"The secondary endpoint was defined as number of patients achieving clinical response according to ACR20 (20% response, defined by ACR) between CT-P13 SC and CT-P13 IV groups. The results up to Week 6 represented the efficacy of CT-P13 IV loading dose (3 mg/kg) regardless of randomized treatment arm (CT-P13 SC or CT-P13 IV).~Responder according to the ACR20 criteria defined as, if they are fulfilled, a decrease of at least 20% in number of tender joints and swollen joints (0-28), and 20% improvement in 3 of the followings: patient assessment of pain on VAS (0-100 mm), patient global assessment of disease activity on VAS (0-100 mm) and physician global assessment of disease activity on VAS (0-100 mm), health assessment questionnaire disability index and CRP or ESR (erythrocyte sedimentation rate)."|Week 2, Week 6, Week 14, Week 22, Week 30, and Week 54|The efficacy population consisted of all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 IV or CT-P13 SC) at Week 6 or thereafter, and who had at least 1 efficacy evaluation result after Week 6 and thereafter treatment. All patients in efficacy population were analyzed according to the treatment they received.|||Participants|||Count of Participants
2537079|NCT03147248|Secondary|Mean Actual Value of Disease Activity Score Using 28 Joint Counts (DAS28 [CRP]) (Part 2)|The secondary endpoint was defined as descriptive statistics of actual value in disease activity measured by DAS28 (CRP) up to Week 54. The results up to Week 6 represented the efficacy of CT-P13 IV loading dose (3 mg/kg) regardless of randomized treatment arm (CT-P13 SC or CT-P13 IV) in both treatment arms. DAS28 (CRP) was calculated according to the following formula: DAS28 (CRP) = (0.56* √ of TJC28) + (0.28 * √ of SJC28) + (0.36 * ln(CRP [mg/L] + 1)) + (0.014 * GH on VAS) + 0.96. DAS28 (CRP) provides a number on a scale from 0 to 10 indicating the current activity of the patients with RA. DAS28 (CRP) score above 5.1 indicates high disease activity, whereas DAS28 (CRP) score below 3.2 indicates low disease activity.|Baseline, Week 2, Week 6, Week 14, Week 22, Week 30, and Week 54|The efficacy population consisted of all randomly assigned patients who received at least 1 full dose of study drug (CT-P13 IV or CT-P13 SC) at Week 6 or thereafter, and who had at least 1 efficacy evaluation result after Week 6 and thereafter treatment. All patients in efficacy population were analyzed according to the treatment they received.|||score on a scale||Standard Deviation|Mean
2537117|NCT03143166|Secondary|Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Free Dabigatran (AUC0-tz).|This endpoint calculates area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 to the time of last quantifiable time point.|Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose.|PKS|||Nanogram*Hour/ millilitre (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2537080|NCT03147248|Primary|Change From Baseline of Disease Activity Score Using 28 Joint Counts (DAS28) (CRP) at Week 22 (Part 2)|For Part 2, the primary efficacy endpoint was to demonstrate that CT-P13 SC 120 mg is non-inferior to CT-P13 IV 3 mg/kg at Week 22, as determined by clinical response according to mean change from baseline in DAS28 (CRP) at Week 22, using Analysis of Covariance (ANCOVA). Change from baseline for ANCOVA was defined as decrease from baseline and calculated as (DAS28 [CRP] at baseline - DAS28 [CRP] at Week 22). DAS28 (CRP) was calculated using the following formula: DAS28 (CRP) equals(=) (0.56 multiplied by [*] the square root [√] of TJC28 [tender joint count]) plus (+) (0.28 * √ of SJC28 [swollen joint count]) + (0.36 * the natural logarithm [ln](CRP [mg/L] + 1)) + (0.014 * patient global disease activity [GH] on visual analogue assessment [VAS]) + 0.96. DAS28 (CRP) provides a number on a scale from 0 to 10 indicating the current activity of patients with RA. DAS28 (CRP) score above 5.1 indicates high disease activity, whereas DAS28 (CRP) score below 3.2 indicates low disease activity.|Week 22|Efficacy population consisted of all randomly assigned patients who received at least 1 full dose of study drug at Week 6 or thereafter and had at least 1 efficacy result after Week 6. Among them, patients who had DAS28 (CRP) at Week 22 were included for the analysis. All patients were analyzed according to the treatment they received.|||score on a scale||Standard Error|Least Squares Mean
2537081|NCT03147248|Primary|Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1)|For Part 1, the primary pharmacokinetic (PK) endpoint of the AUCτ (area under the concentration-time curve) at steady state between Week 22 and Week 30 was analyzed in patients who received all doses (full) of study drug up to Week 30 (prior to Week 30) in the PK population. All patients in SC cohorts were randomly assigned at Week 14 in a 1:1 ratio to either Group A or B for PK monitoring visit period (Week 22 and Week 30). Therefore, AUCτ was calculated at Week 22 for Cohort 1: CT-P13 IV 3 mg/kg, Weeks 22 and 26 for Group A of SC cohorts, and Weeks 24 and 28 for Group B of SC cohorts.|Weeks 22 (pre-dose to 216 hours post-dose), 24 (14 days after start of administration [SOA] at Week 22), 26 (pre-dose) and 28 (42 days after SOA at Week 22), and Week 30 (pre-dose)|The PK population consisted of the all-randomized population who received at least 1 full dose of study drug at Week 6 or thereafter and who had at least 1 PK concentration result after Week 6 treatment. Among them, patients who had AUCτ result at steady state were included for the primary analysis.|||hr*ng/mL||Standard Deviation|Mean
2537082|NCT03146741|Primary|Number of Severe Adverse Events (SAE) Attributable to HCV Therapy Post-heart Transplant||Baseline to 52 weeks||||Severe adverse event|||Number
2537083|NCT03146741|Primary|Number of Participants With Post-treatment Sustained Virologic Response (SVR)|The primary analysis will be based on a calculation of SVR rates (number of subjects with SVR; negative HCV RNA after completing Zepatier therapy) / (number of subjects treated with Zepatier post-heart transplantation)|Baseline to 24 weeks||||Participants|||Count of Participants
2537084|NCT03146585|Primary|Perfused Boundary Region (PBR) in One Week|PBR is an indirect measure of assessment of the endothelial glycocalyx thickness in sublingual microcirculation.|One week on ICU||||micrometer||Inter-Quartile Range|Median
2537085|NCT03146403|Secondary|Duration of Genital Herpes Recurrences|Time in days per genital herpes recurrence|The 6-month period after vaccination||||days||Full Range|Median
2537086|NCT03146403|Secondary|Days Until First Genital Herpes Recurrence|Subject-reported via electronic diary|The 6-month period after vaccination|Results for the placebo group are based on 16 subjects, after excluding one subject who reported no electronic diary lesion data.|||days||95% Confidence Interval|Median
2537087|NCT03146403|Secondary|Number of Subjects Without Genital Herpes Recurrence|Subject-reported via electronic diary|6 months after vaccination|Results for the placebo group are based on 16 subjects, after excluding one subject who reported no electronic diary lesion data.|||Participants|||Count of Participants
2537088|NCT03146403|Secondary|Number of Genital Herpes Recurrences|Subject-reported via electronic diary|The 6-month period after vaccination|Results for the placebo group are based on 16 subjects, after excluding one subject who reported no electronic diary lesion data.|||recurrences||Full Range|Median
2537089|NCT03146403|Primary|Percentage of Days With Genital Herpes Lesions|Subject-reported via electronic diary|The 6-month period after vaccination|Results for the placebo group are based on 16 subjects, after excluding one subject who reported no electronic diary lesion data.|||percentage of days||Full Range|Median
2537090|NCT03144635|Secondary|Count of Participants With NS3/4A or NS5A Muttations Who Achieved SVR12|We identified the NS3/4A or NS5A muttations by direct sequencing at baseline. Among participants who had mutations, we calcualted the rate of SVR12.|3 months||||Participants|||Count of Participants
2537091|NCT03144635|Secondary|Change of Serum Alpha-fetoprotein Level (ng/mL) From Baseline to 3 Months|We evaluated the serum alpha-fetoprotein levels at baseline and 3 months after the treatment initiation.|3 months||||ng/mL||Standard Deviation|Mean
2537092|NCT03144635|Secondary|Change of Serum Alanine Aminotransferase (ALT) Level (U/L) From Baseline to 3 Months|We evaluated the serum ALT levels at baseline and 3 months after the treatment initiation.|3 months||||U/L||Standard Deviation|Mean
2537093|NCT03144635|Secondary|Sustained Virological Response-12 (SVR12)|SVR12 was defined as undetectable HCV RNA at week 12 after the end of treatment.|3 months|Three patients discontinued treatment due to adverse effects.|||Participants|||Count of Participants
2537094|NCT03144635|Primary|Change of eGFR Level (mL/Min/1.73m^2) From Baseline to 3 Months|We evaluated eGFR level at baseline and 3 months after the treatment initiation.|3 months||||mL/min/1.73m^2||Standard Deviation|Mean
2537095|NCT03144635|Primary|Change of Serum Endostatin Level (ng/mL) From Baseline to 3 Months|We evaluated the serum endostatin at baseline and 3 months after the treatment initiation.|3 months||||ng/mL||Standard Deviation|Mean
2537096|NCT03144518|Secondary|Health Care Utilization|Via medical records, we assessed health care usage potentially attributable to flu-like symptoms (e.g., GP visits, hospitalisation, antibiotic prescription) during the 6 months post-vaccination|Baseline to 6 months post-vaccination||||Participants|||Count of Participants
2537097|NCT03144518|Secondary|Vaccine Specific IgG Response|"IgG levels against the 4 vaccine strains measured via ELISA.~Values represent equivalent ug/ml based on diluted sample absorbance value interpolation against a standard IgG curve, multiplied by the serum dilution score (i.e., 4000)."|4 weeks (post-vaccination), 16 Weeks (post-vaccination)|Missing Data Count: n=1 for 4 weeks post-vaccination, n=5 for 16 weeks post-vaccination|||ug/ml||Standard Deviation|Mean
2537101|NCT03144518|Primary|Mood Outcome Scores [Multiple]|"Affective Slider (Betella & Verschure, 2016), consists of two single item visual analogue scales. Scores for each are presented as a value from 0 to 100 with higher scores indicating greater pleasure (VAS-Valence) and arousal (VAS-Arousal).~Positive and Negative Affect Schedule (Watson et al., 1988). Positive and negative affect subscales were created by summing the scores of positive and negative adjectives respectively. For each sub scale, minimum score = 10, maximum score = 50 with higher scores indicating greater positive and negative affect respectively.~Pictorial scale of positive affect (unvalidated, internally developed). Participants completed a single-item photo-based measure of positive affect tailored for older adults. Participants were presented with six groups of images depicting varying degrees of positive affect, and indicate which best reflected how they felt at that moment. Minumum score 1, maximum score 6, higher scores indicate greater positive affect."|Baseline, Immediately Post Intervention (i.e, 15 minutes post-baseline).|Missing Data for some outcome measures - i.e., incomplete scale|||score on a scale||Standard Deviation|Mean
2537102|NCT03144180|Secondary|Fill Capacity of Umbilical Cord Blood Using the Qcup Compared to Standard of Care|Participant delivery providers were asked to self-administer a survey in which they were to assess the fill capacity of the lab tubes using the Qcup or the standard method. Possible choices were filled to capacity and not filled to capacity. Some delivery providers did not fill out the surveys and therefore, data was missing.|12 weeks|All participants randomized to Standard of Care or Qcup. Delivery Providers filled out the survey in regards to the fill capacity.|||Participants|||Count of Participants
2537103|NCT03144180|Secondary|Determining Umbilical Cord Collection Cleanliness With the Q-cup as Compared to the Standard Blood Collection Method|Participants' delivery providers were asked to self-administer a survey in which they were to assess blood collection for cleanliness. Possible choices were excellent/ good or fair/poor. Some delivery providers did not fill out the surveys and therefore, data was missing.|At Delivery which could be between 1 to 12 weeks after Baseline.|All participants randomized to Standard of Care or Qcup. Delivery Providers filled out the survey in regards to the collection method.|||Participants|||Count of Participants
2537104|NCT03144180|Primary|Mean Blood Collection Time|Anticipating the average lengths of cord blood collection with the standard method is 15 seconds and 30 seconds with the Q-cup, we needed 30 subjects total. 15 in the Q-cup arm of the study and 15 in the comparison group (for a two-sided two-sample t-test with 80% power, an alpha of 0.05, and a common standard deviation of 14 seconds). 30 participants were recruited into the study, however, the delivery providers were in charge of collecting this outcome.|12 weeks|All participants were assigned to the standard of care or the q-cup. The delivery providers collected this outcome.|||Seconds||Standard Deviation|Mean
2537105|NCT03143569|Secondary|Time to Therapeutic Dose|Amount of time needed to achieve therapeutic dose from heparin initiation|14 days of heparin therapy||||hours||Inter-Quartile Range|Median
2537106|NCT03143569|Secondary|Dosing Changes|Number of dosing changes during heparin therapy until first therapeutic|14 days of heparin therapy||||dosing changes||Inter-Quartile Range|Median
2537107|NCT03143569|Secondary|Nomogram Concordance|"Compare heparin dosing success between aPTT and anti-factor Xa nomograms. If aPTT was within therapeutic range of nomogram AND anti-factor Xa was within range in therapeutic nomogram, then paired values were deemed concordent. Similiarly if both aPTT AND anti-factor Xa were above therapeutic range OR both below therapeutic range, then paired valued were deemed concordent. Otherwise values deemd discordant"|14 days of heparin therapy|paired aPTT samples compared with antiXa samples|||tests|tests||Count of Units
2537108|NCT03143569|Primary|Success of Nomogram|Amount of time sustained in therapeutic anticoagulation range|14 days of heparin therapy|Each group received heparin anticoagulation and had heparin administration guided by a nomogram based on one of two different laboratory assays, aPTT or anti-Xa.|||% of time patients test was therapeutic||Inter-Quartile Range|Median
2537109|NCT03143569|Primary|Nomogram Feasibility|Questionnaires evaluating pragmatic application of nomograms. Question 5: I often had to seek clarification from a coworker, pharmacist, NP, or MD regarding the nomogram instructions.|14 days of heparin therapy||||Surveys|Surveys||Number
2537110|NCT03143569|Primary|Nomogram Feasibility|Questionnaires evaluating pragmatic application of nomograms. Question 4: When my patient is on the heparin nomogram, I follow the dosing and monitoring instructions exactly.|14 days of heparin therapy||||Surveys|Surveys||Number
2537111|NCT03143569|Primary|Nomogram Feasibility|Questionnaires evaluating pragmatic application of nomograms. Question 3: Overall, I feel that this dosing nomogram is feasible.|14 days of heparin therapy|Collected Survey responses from bedside nurses. All surveys were collected as intended.|||Surveys|Surveys||Number
2537112|NCT03143569|Primary|Nomogram Feasibility|Questionnaires evaluating pragmatic application of nomograms. Question 2: Overall, I am satisfied with the utilization and implementation of the heparin monitoring nomogram.|14 days of heparin therapy|Collected Survey responses from bedside nurses. All surveys were collected as intended.|||Surveys|Surveys||Number
2537113|NCT03143569|Primary|Nomogram Feasibility|Questionnaires evaluating pragmatic application of nomograms. Question 1: The current heparin nomogram using (aPTT or anti-Xa depending on group) monitoring is easy to follow.|14 days of heparin therapy||||Surveys|Surveys||Number
2537114|NCT03143166|Secondary|Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).|This endpoint calculates area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity.|Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose.|PKS|||Nanogram*Hour/ millilitre (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2537115|NCT03143166|Secondary|Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).|This endpoint calculates area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity|Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose.|PKS|||Nanogram*Hour/ millilitre (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2537116|NCT03143166|Secondary|Maximum Concentration of Free Dabigatran in Plasma (Cmax).|This outcome is maximum measured concentration of the free dabigatran in plasma|Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose.|PKS|||Nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2537119|NCT03143166|Primary|Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Total Dabigatran (AUC0-tz).|This endpoint calculates area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 to the time of last quantifiable time point.|Samples were collected 1 hour Pre-dose and at 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00 36:00 and 48:00 hours post dose.|Pharmacokinetic set (PKS): All treated subjects who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of Pharmacokinetic (PK) endpoints were included in PKS.|||Nanogram*Hour/ millilitre (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2537120|NCT03143101|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug.|Day 1 through Day 28 after Dose 1 (Day 1 dose) and Dose 2 (Day 28 dose)|ATP included all participants who received any investigational drug.|||Participants|||Count of Participants
2537121|NCT03143101|Secondary|Percentage of Participants With Any Solicited Symptoms|Solicited symptoms included fever by any route (temperature >= 100.4 degrees Fahrenheit), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, lethargy or tiredness/weakness, and decreased appetite.|Day 1 through Day 14 after Dose 1 (Day 1 dose) and Dose 2 (Day 28 dose)|ATP included all participants who received any investigational drug.|||Percentage of participants|||Number
2537122|NCT03143101|Secondary|Percentage of Participants With Any Post Dose Strain-specific Antibody Response|Strain specific antibody response defined as >= 4-fold increase in HAI antibodies or >= 4-fold increase in neutralizing antibodies or >= 2-fold increase in IgA antibodies.|Days 28 and 56|Immunogenicity population. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm.|||Percentage of participants|||Number
2537123|NCT03143101|Secondary|Percentage of Participants With Strain-specific Nasal Immunoglobulin A (IgA) Seroconversion Rate From Baseline Through Days 28 and 56|Seroconversion rate is defined as >= 2-fold rise from baseline in strain speciific nasal IgA antibody titer. Percentage of participants with >= 2-fold rise in strain speciific nasal IgA antibody titer at Days 28 and 56 are reported for this outcome.|Days 28 and 56|Immunogenicity population. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm.|||Percentage of participants||95% Confidence Interval|Number
2537124|NCT03143101|Secondary|Percentage of Participants With Strain-specific Neutralizing Antibody Seroconversion Rates From Baseline Through Days 28 and 56 by Baseline Serostatus|Seroconversion rate is defined as >= 4-fold rise from baseline in strain specific microneutralizing antibody titer. Baseline microneutralization values of less than or equal to (<=) 10 were considered as microneutralization status negative and values greater than (>) 10 were considered microneutralization positive. Percentage of participants with >= 4-fold rise in strain specific neutralizing antibody titer at Days 28 and 56 are reported.|Days 28 and 56|Immunogenicity population. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm.|||Percentage of participants||95% Confidence Interval|Number
2537125|NCT03143101|Secondary|Viral Titer by Day, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR|Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) was used to measure viral titer from the nasopharyngeal swabs. Viral titers are reported.|Day (D) 2, D3, D4, D5, and D7 after Dose 1 (D1 dose) and on D2, D4 and D6 after Dose 2 (D28 dose)|Participants included in immunogenicity population and who shed vaccine virus were analyzed for this outcome measure. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm.|||log10 viral particles/mL||Standard Deviation|Mean
2537126|NCT03143101|Secondary|Number of Days of Vaccine Virus Shedding by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by qRT-PCR|Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) was used to measure viral shedding from the nasopharyngeal swabs. Number of days of virus shedding are reported.|Days 2, 3, 4, 5, and 7 after Dose 1 (Day 1 dose) and on Days 2, 4 and 6 after Dose 2 (Day 28 dose)|Participants included in immunogenicity population and who shed vaccine virus were analyzed for this outcome measure. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm.|||Days||Standard Deviation|Mean
2537127|NCT03143101|Secondary|Percentage of Participants Who Shed Vaccine Virus by Formulation, Strain, Dose Number, and Baseline Serostatus as Measured by Quantitative Reverse Transcriptase Polymerase Chain Reaction (qRT-PCR)|Quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) was used to measure viral shedding from the nasopharyngeal swabs. Percentage of participants who shed virus are reported.|Days 2, 3, 4, 5, and 7 after Dose 1 (Day 1 dose) and on Days 2, 4, and 6 after Dose 2 (Day 28 dose)|Immunogenicity population. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm.|||Percentage of participants|||Number
2537128|NCT03143101|Primary|Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 56|Seroconversion rate is defined as >= 4-fold rise from baseline in B/Victoria HAI antibody titer. Percentage of participants with >= 4-fold rise in B/Victoria HAI antibody titer at Day 56 is reported.|Day 56|"Immunogenicity population. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm. Here, N signifies number of participants analyzed for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2537129|NCT03143101|Primary|Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 56|Seroconversion rate is defined as >= 4-fold rise from baseline in B/Yamagata HAI antibody titer. Percentage of participants with >= 4-fold rise in B/Yamagata HAI antibody titer at Day 56 is reported.|Day 56|"Immunogenicity population included all participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. Here, N signifies number of participants analyzed for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2537160|NCT03141528|Primary|Percentage of Correct Compressions|The percentage of correct compressions obtained from the printed report from the Laerdal Skill Reporter.|after first BLS course and 3 months later||||percentage of correct compressions||Inter-Quartile Range|Median
2537130|NCT03143101|Primary|Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 56|Seroconversion rate is defined as >= 4-fold rise from baseline in A/H3N2 HAI antibody titer. Percentage of participants with >= 4-fold rise in A/H3N2 HAI antibody titer at Day 56 is reported.|Day 56|"Immunogenicity population included all participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. Here, N signifies number of participants analyzed for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2537131|NCT03143101|Primary|Percentage of Participants With A/H1N1 HAI Antibody Seroconversion Rate at Day 56|Seroconversion rate is defined as >= 4-fold rise from baseline in A/H1N1 HAI antibody titer. Percentage of participants with >= 4-fold rise in A/H1N1 HAI antibody titer at Day 56 is reported. Comparative statistical analysis was planned only for 'FluMist Quadrivalent (2015-2016)' and 'FluMist Quadrivalent (2017-2018)' arms.|Day 56|"Immunogenicity population included all participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. Here, N signifies number of participants analyzed for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2537132|NCT03143101|Primary|Percentage of Participants With B/Victoria HAI Antibody Seroconversion Rate at Day 28|Seroconversion rate is defined as >= 4-fold rise from baseline in B/Victoria HAI antibody titer. Percentage of participants with >= 4-fold rise in B/Victoria HAI antibody titer at Day 28 is reported.|Day 28|"Immunogenicity population. B/Victoria strain was not included in the 'FluMist trivalent (2015-2016)' arm. Here, N signifies number of participants analyzed for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2537133|NCT03143101|Primary|Percentage of Participants With B/Yamagata HAI Antibody Seroconversion Rate at Day 28|Seroconversion rate is defined as >= 4-fold rise from baseline in B/Yamagata HAI antibody titer. Percentage of participants with >= 4-fold rise in B/Yamagata HAI antibody titer at Day 28 is reported.|Day 28|"Immunogenicity population included all participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. Here, N signifies number of participants analyzed for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2537134|NCT03143101|Primary|Percentage of Participants With A/H3N2 HAI Antibody Seroconversion Rate at Day 28|Seroconversion rate is defined as >= 4-fold rise from baseline in A/H3N2 HAI antibody titer. Percentage of participants with >= 4-fold rise in A/H3N2 HAI antibody titer at Day 28 is reported.|Day 28|"Immunogenicity population included all participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. Here, N signifies number of participants analyzed for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2537135|NCT03143101|Primary|Percentage of Participants With A/H1N1 Hemagglutination Inhibition (HAI) Antibody Seroconversion Rate at Day 28|Seroconversion rate is defined as at least (>=) 4-fold rise from baseline in A/H1N1 HAI antibody titer. Percentage of participants with >= 4-fold rise in A/H1N1 HAI antibody titer at Day 28 is reported. Comparative statistical analysis was planned only for 'FluMist Quadrivalent (2015-2016)' and 'FluMist Quadrivalent (2017-2018)' arms.|Day 28|"Immunogenicity population included all participants in the as-treated population (ATP) who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to investigational product. Here, N signifies number of participants analyzed for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2537136|NCT03142932|Secondary|Reasons for Quitting Scale|We used the Reasons for Quitting (RFQ) scale to measure motivation to quit smoking. The scale is used to measure intrinsic and extrinsic motivation for quitting smoking. Each item in the scale is evaluated using a 5-point Likert scale regarding how true the statement is about the participant's motivation to quit smoking (Not at all true, a little bit true, moderately true, quite true, extremely true). Each option takes on a numerical score from 0 (not at all true) to 4 (extremely true). Scores are summed across all items in the scale and divided by the number of items in the scale to obtain the RFQ score. The range of possible scores is 0 to 4. A higher score indicates greater motivation to quit smoking.|baseline|Thirteen participants were lost to follow-up (9 at the 14-day visit and 4 at the 30-day visit) and the sample size for the analysis was 89. There were no significant differences in baseline characteristics between participants lost to follow-up and participants who completed the study.|||score on a scale||95% Confidence Interval|Mean
2537137|NCT03142932|Primary|Number of Participants With Color Change for Urine Test for Measuring Cotinine|A point of care urine test for measuring cotinine will also be conducted via the SmokeScreen® test from GFC Diagnostics Ltd. to verify smoking status. A color change to red/orange indicates a positive sample, with a darker color indicating greater nicotine intake.|1 month|Thirteen participants were lost to follow-up (9 at the 14-day visit and 4 at the 30-day visit) and the sample size for the analysis was 89. There were no significant differences in baseline characteristics between participants lost to follow-up and participants who completed the study.|||participants|||Number
2537138|NCT03142932|Primary|Number of Participants With Color Change for Urine Test for Measuring Cotinine|A point of care urine test for measuring cotinine will also be conducted via the SmokeScreen® test from GFC Diagnostics Ltd. to verify smoking status. A color change to red/orange indicates a positive sample, with a darker color indicating greater nicotine intake.|baseline|Thirteen participants were lost to follow-up (9 at the 14-day visit and 4 at the 30-day visit) and the sample size for the analysis was 89. There were no significant differences in baseline characteristics between participants lost to follow-up and participants who completed the study.|||participants|||Number
2537139|NCT03142932|Primary|Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)|A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 10ppm will indicate abstinence.|1 month|Thirteen participants were lost to follow-up (9 at the 14-day visit and 4 at the 30-day visit) and the sample size for the analysis was 89. There were no significant differences in baseline characteristics between participants lost to follow-up and participants who completed the study.|||parts per million||Inter-Quartile Range|Median
2537140|NCT03142932|Primary|Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)|A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 10ppm will indicate abstinence.|baseline|Thirteen participants were lost to follow-up (9 at the 14-day visit and 4 at the 30-day visit) and the sample size for the analysis was 89. There were no significant differences in baseline characteristics between participants lost to follow-up and participants who completed the study.|||parts per million||Inter-Quartile Range|Median
2537141|NCT03142750|Primary|Number of Participants Satisfied With Experimental Dressings|"Overall satisfaction of the dressings when assessed using a qualitative questionnaire. Questionnaires queried the level of agreement in the following aspects: overall satisfaction, ease of use, adequate level of security for the G-button, ease of connecting and disconnecting the feeding tube, reduction in leakage, painless device removal, improvement in gastrostomy wound appearance, preference over the traditional dressing, and whether they would purchase the securement device if it was commercially available. Answer choices to measure level of satisfaction were: strongly agree, agree, neutral, disagree, strongly disagree. Surveys also included open-ended questions about participant satisfaction. Survey responses were evaluated and determined to indicate Satisfied or Not Satisfied by the Investigators."|1 Week|4 subjects in the Saddle & Foam group and 1 in the Third Prototype did not complete the satisfaction surveys.|||Participants|||Count of Participants
2537142|NCT03142750|Primary|Number of Participants Satisfied With Current Dressings|"Overall satisfaction of the current dressings used at baseline were assessed using a qualitative questionnaire. Questionnaires queried the level of agreement in the following aspects: overall satisfaction, ease of use, adequate level of security for the G-button, adherence to skin, ability to absorb leakage, cost, availability at drug store, allergenic potential and reusability. Answer choices to measure level of satisfaction were: strongly agree, agree, neutral, disagree, strongly disagree. Surveys also included open-ended questions about participant satisfaction. Survey responses were evaluated and determined to indicate Satisfied or Not Satisfied by the Investigators.This measurement reflects participants satisfaction with whatever dressing they were currently using at baseline, not with the study interventions to which they were assigned."|Baseline|Only participants from the Foam Gastrostomy Tube Dressing and Saddle Gastrostomy Tube dressing completed this baseline measure. No participants from the Third Prototype group completed this baseline measure|||Participants|||Count of Participants
2537143|NCT03141528|Secondary|Time From Start of Test Till First Shock|Time measured from the beginning of the test until the participant gives the first shock.|after first BLS course and 3 months later||||seconds||Inter-Quartile Range|Median
2537144|NCT03141528|Secondary|Time From Start of Test Till First Ventilation|Time measured from the beginning of the test until the participant makes the first ventilation.|after first BLS course and 3 months later||||seconds||Inter-Quartile Range|Median
2537145|NCT03141528|Secondary|Time From Start of Test Till First Compression|Time measured from the beginning of the test until the participant makes the first compression.|after first BLS course and 3 months later||||seconds||Inter-Quartile Range|Median
2537146|NCT03141528|Secondary|Time From Start of Test Till Call for Help|Time measured from the beginning of the test until the participant calls for help.|after first BLS course and 3 months later||||seconds||Inter-Quartile Range|Median
2537147|NCT03141528|Secondary|Incomplete Decompression|Incomplete decompression from the Laerdal Skill Reporter (LSR)|after first BLS course and 3 months later||||percentage of Incomplete decompression||Inter-Quartile Range|Median
2537148|NCT03141528|Secondary|False Hand Placement During Compressions|False hand placement during compressions.|after first BLS course and 3 months later||||percentage of False hand placement durin||Inter-Quartile Range|Median
2537149|NCT03141528|Secondary|Compressions Too Shallow|Total percentage of Compressions too shallow from the Laerdal Skill Reporter (LSR)|after first BLS course and 3 months later||||percentage of Compressions too shallow||Inter-Quartile Range|Median
2537150|NCT03141528|Secondary|Compression Frequency|Compression frequency from the Laerdal Skill Reporter (LSR). Compressions per minute ventilation break included.|after first BLS course and 3 months later||||compressions per minute||Inter-Quartile Range|Median
2537151|NCT03141528|Secondary|Number of Compressions Per Minute|Number of compressions per minute from the Laerdal Skill Reporter (LSR)|after first BLS course and 3 months later||||compressions per minute||Inter-Quartile Range|Median
2537152|NCT03141528|Secondary|Compression Depth|Compression depth from the printed report from the Laerdal Skill Reporter (LSR)|after first BLS course and 3 months later||||mm||Inter-Quartile Range|Median
2537153|NCT03141528|Secondary|Number of Participants Using Correct Ratio of Compressions:Ventilations|the relationship between ventilations and compressions from the printed report from the Laerdal Skill Reporter (LSR). Ventilations - relationship 30 compressions and 2 ventilations.|after first BLS course and 3 months later||||Participants|||Count of Participants
2537154|NCT03141528|Secondary|Percentage of Correct Ventilations|Percentage of correct ventilations from the printed report from the Laerdal Skill Reporter (LSR)|after first BLS course and 3 months later||||percentage of corrent ventilations||Inter-Quartile Range|Median
2537155|NCT03141528|Secondary|Number of Ventilations Per Minute|Number of ventilations per minute from the printed report from the Laerdal Skill Reporter (LSR)|after first BLS course and 3 months later||||(ventilations/min)||Inter-Quartile Range|Median
2537156|NCT03141528|Secondary|Average Ventilation Volume|Ventilation volume from the printed report from the Laerdal Skill Reporter (LSR)|after first BLS course and 3 months later||||ml||Inter-Quartile Range|Median
2537157|NCT03141528|Secondary|Assessment of the Teaching Method|"The participants assessment of the teaching method. Rated on a Visual Analogue Scale from 0-100mm, where 0mm = completely inefficient, and 100mm = totally efficient, nothing can be done better."|after first BLS course||||score on a scale||Inter-Quartile Range|Median
2537158|NCT03141528|Secondary|Self-assessment of the Participants BLS Competences Before Test|The participants assessment of their own BLS competences. Rated on a Visual Analogue Scale from 0-100mm, where 0mm = completely incompetent, no idea what to do, and 100mm = totally competent, cannot be done better.|before first BLS course and 3 months later||||score on a scale||Inter-Quartile Range|Median
2537162|NCT03141372|Secondary|Patient Perception of Bladder Condition Score|"The Patient Perception of Bladder Condition will be used to determine if there are any changes to the participants' perception of bladder function before and after surgery.~In this questionnaire, the participant answers one question as follows:~My bladder condition:~0 - Does not cause me any problems at all~- Causes me very minor problems~- Causes me some minor problems~- Causes me (some) moderate problems~- Causes me severe problems~- Causes me many severe problems~The score was recorded for each patient. The range of possible scores were 0 to 5 with 0 being the best and 5 being the worst scores."|presurgery and at 10-14 days post-surgery||||score on a scale||Inter-Quartile Range|Median
2537163|NCT03141372|Secondary|Quality of Bladder Function Using the Incontinence Impact Questionnaire|"The Incontinence Impact Questionnaire-7 will be used to determine if there are any changes to the participants' short term quality of life before and after surgery. The questionnaire includes 7 questions asking how the participant's bladder function has affected her:~Ability to do household chores.~Physical recreation~Entertainment activities~Ability to travel by car or bus more than 30 minutes from home~Participation in social activities outside the home~Emotional health~Feeling frustrated~The patient scores each of the questions using the following scale:~0 - Not at all~- Slightly~- Moderately~- Greatly~The scores were added and divided by 7 to obtain an average score for each participant. Hence the range of scores is 0 to 3 with 0 being the best and 3 being the worst."|pre-surgery and 14 days post-surgery||||scores on a scale||Inter-Quartile Range|Median
2537164|NCT03141372|Secondary|Number of Participants With Post-Operative Urinary Tract Infection|Any participant diagnosed with a culture-proven urinary tract infection will be noted.|up to 14 days post-surgery||||Participants|||Count of Participants
2537165|NCT03141372|Secondary|Number of Patients With Urinary Retention|After discharge, participants will be monitored for any encounters for urinary retention (in our hospital system) and will be asked at their 10-14 day post-operative visit if they had a Foley catheter placed outside the hospital. Additionally, any participant who fails their 2nd void trial will be noted. The incidence of urinary retention post-discharge will be determined using this data.|10-14 days post-surgery||||Participants|||Count of Participants
2537166|NCT03141372|Secondary|Time to Discharge|The time to discharge will be measured for each participant. This will be determined by calculating the time between arrival to the post-anesthesia care unit and the time of discharge using documentation from Epic and from the case report forms.|post-operative day, about 4 hours post-surgery||||minutes||Inter-Quartile Range|Median
2537167|NCT03141372|Primary|Number of Participants With Void Trial Failure Rate|The primary endpoint of this study will be to determine if the rate of void trial failure after total laparoscopic hysterectomy is different after the autofill method versus the backfill method.|post-operative day, about 4 hours post-surgery||||Participants|||Count of Participants
2537168|NCT03141307|Secondary|Residual Decisional Regret|The Residual Decisional Regret measure assesses a person's feelings of regret after making a decision (in this specific case, participation in the Michigan BioTrust). Scores range from 1 to 5 with lower values indicating better outcomes due to less regret. The scale is created by taking the mean of 5 items.|Administered at the 2-4 week follow-up|The number of participants analyzed does not match the numbers in the participant flow due to missing data at the question level. Participants were not required to answer every single question on the survey.|||units on a scale||Standard Deviation|Mean
2537169|NCT03141307|Secondary|Residual Quality of Informed Consent|"Assessment of how well the participant understood different aspects of the study after a gap in time.~The Residual Quality of Informed Consent is a repetition of the Quality of Informed Consent measure, now provided 2-4 weeks after the intervention. This measure assesses how well the participant self-reports their understanding different aspects of the study he/she consented into (Joffe et al., 2001). Scores range from 1 to 5 with higher scores indicating better self-reported understanding of the elements of consent. The scale is created by taking the mean of 14 items."|Administered at the 2-4 week follow-up|The number of participants analyzed does not match the numbers in the participant flow due to missing data at the question level. Participants were not required to answer every single question on the survey.|||score on a scale||Standard Deviation|Mean
2537170|NCT03141307|Secondary|Residual Comprehension for Biobanking|"This is a repetition of the Comprehension for Biobanking survey assessed immediately after the intervention. The residual Comprehension for Biobanking survey assesses a person's retention of knowledge of the Michigan BioTrust program two to 4 weeks after the intervention.~Scale range: 0-1 The reported scale is derived from the number of correct answers divided by 20 for a percentage correct. Thus, a score of .6 indicates a 60% correct response rate. Higher values indicate more comprehension of the presented information. Lower values indicate less comprehension of the presented information."|Administered at the 2-4 week follow-up|The number of participants analyzed does not match the numbers in the participant flow due to missing data at the question level. Participants were not required to answer every single question on the survey.|||score on a scale||Standard Deviation|Mean
2537171|NCT03141307|Secondary|Attitudes Survey|Assesses support of the Michigan BioTrust program. This is a single item assessment. Full scale range is 1 to 4. Higher values indicate more support of the Michigan BioTrust. The scale is a likert scale: 1 = Not supportive at all, 4 = Very supportive|Administered at the 2-4 week follow-up|The number of participants analyzed does not match the numbers in the participant flow due to missing data at the question level. Participants were not required to answer every single question on the survey.|||score on a scale||Standard Deviation|Mean
2537172|NCT03141307|Secondary|Quality of Informed Consent|The Quality of Informed Consent assesses how well the participant self-reports their understanding different aspects of the study he/she consented into (Joffe et al., 2001). Scores range from 1 to 5 with higher scores indicating better self-reported understanding of the elements of consent. The scale is created by taking the mean of 14 items.|Administered immediately after the intervention|The analysis population differs from the number of participants enrolled because the initial 15 to 20 participants at each hospital were considered to be run-in participants during which the protocol was evaluated for its effectiveness at that site and adjusted as needed. Our analysis plan was written to exclude these run-in participants.|||score on a scale||Standard Deviation|Mean
2537248|NCT03138382|Primary|Change in Fat Consumption (During VeNS)|Change in percent fat utilization from baseline as measured using indirect calorimetry.|During middle 15 minutes of 45 minute vestibular nerve stimulation session||||% of fat as metabolic substrate||Standard Deviation|Mean
2537173|NCT03141307|Primary|Comprehension for Biobanking at Time of Consent|"Questions based on the 16-item biobank checklist developed from consensus-based guidelines for adequate comprehension for biobanking (see Beskow et al. 2014). This measure assesses a person's understanding of the Michigan BioTrust program.~Scale range: 0-1 The reported scale is derived from the number of correct answers divided by 20 for a percentage correct. Thus, a score of .6 indicates a 60% correct response rate. Higher values indicate more comprehension of the presented information. Lower values indicate less comprehension of the presented information."|Administered immediately after the intervention|The analysis population differs from the number of participants enrolled because the initial 15 to 20 participants at each hospital were considered to be run-in participants during which the protocol was evaluated for its effectiveness at that site and adjusted as needed. Our analysis plan was written to exclude these run-in participants.|||score on a scale||Standard Deviation|Mean
2537174|NCT03141151|Secondary|Parenting Practices: Engagement|Self-reported survey data; Parenting practices around child physical activity were measured by the Preschooler Physical Activity Parenting Practices (PPAPP) scale which has an engagement subscale. Parenting practices: Engagement was a 15 item subscale of the PPAPP survey with higher scores representing higher parent engagement practices. Items ranged on a scale from 1-5 and were summed to create the subscale which ranged from 15-75.|4 months|Secondary analysis was based on participants with complete data on the Parent Practices: Engagement measure at baseline and 4 month follow-up timepoints. Note: number of participants analyzed differs slightly from the primary analysis of the primary outcome which was Child BMI.|||score on a scale||Standard Deviation|Mean
2537175|NCT03141151|Secondary|Parent Diet Practices|Self-reported survey data; Parent diet practices were measured by using a summed score of a 4-item questionnaire of eating behaviors, including overeating, unplanned eating, making poor food choices, and emotional eating. Higher scores represent more unhealthy parent dieting practices. Items ranged on a scale from 0-5 and were summed to create the scale which ranged from 0-20.|4 months|Secondary analysis was based on participants with complete data on the Parent Diet Practices measure at baseline and 4 month follow-up timepoints. Note: number of participants analyzed differs slightly from the primary analysis of the primary outcome which was Child BMI.|||score on a scale||Standard Deviation|Mean
2537176|NCT03141151|Secondary|Parent BMI||4 months|Secondary analysis was based on participants with complete data on the Adult BMI measure at baseline and 4 month follow-up timepoints. Note: number of participants analyzed differs slightly from the primary analysis of the primary outcome which was Child BMI.|||kg/m^2||Standard Deviation|Mean
2537177|NCT03141151|Secondary|Child Physical Activity|Parent-reported survey data|4 months|Secondary analysis was based on participants with complete data on the child active days per week measure at baseline and 4 month follow-up timepoints. Note: number of participants analyzed differs slightly from the primary analysis of the primary outcome which was Child BMI.|||Child active days per week||Standard Deviation|Mean
2537178|NCT03141151|Secondary|Child Diet: Soda|Parent-reported survey data; Child diet: Soda was measured by a single survey item used in the Feeding Infants and Toddlers Study with higher values representing higher frequency of consumption per day. (citation: Ziegler P, Briefel R, Clusen N, et al. Feeding Infants and Toddlers Study (FITS): Development of the FITS survey in comparison to other dietary survey methods. J Am Diet Assoc 2006;106:S12-S27.)|4 months|Secondary analysis was based on participants with complete data on the Child Diet: Soda measure at baseline and 4 month follow-up timepoints. Note: number of participants analyzed differs slightly from the primary analysis of the primary outcome which was Child BMI.|||Sodas/day||Standard Deviation|Mean
2537179|NCT03141151|Primary|Change in Child Body Mass Index|child BMI trajectory across 12 months; BMI differences over time are estimates from the longitudinal mixed-effects regression model|Baseline, 4 months, 7 months, 1 year|Number analyzed differs across each time point as it relates to retention|||kg/m^2||Standard Deviation|Mean
2537180|NCT03141086|Secondary|Time Spent in Each Sleep Stage Measured by Polysomnography (PSG)|"N1: is defined by a relatively low amplitude, mixed frequency EEG. N2: is defined by the presence of sleep spindles and/or K complexes and the absence of sufficient high-amplitude, slow activity to define the presence of stage N3 sleep.~N3: is defined as an EEG with at least 20% of an epoch consisting of slow, high amplitude waveforms of .5 - 2 Hz and peak-to-peak amplitude of greater than 75mV.~REM: is defined by the concomitant appearance of relatively low amplitude, mixed frequency EEG activity and episods of rapid eye movement. Sawtooth waves may be present. Chin EMG activity is typically low."|Day 2 (midnight until 08:00) of each treatment period|Safety Analysis Set|||min||Standard Deviation|Mean
2537181|NCT03141086|Secondary|Number of Sleep Cycles Measured by Polysomnography (PSG)|"PSG encompasses the monitoring of subjects in a sleep facility using an array of medical equipment with simultaneously recording on a multi-channel analog or digital system. PSG was performed in the study to record and evaluate various aspects of sleep.~Number of sleep cycles measured by Polysomnography (PSG)."|Day 2 (midnight until 08:00) of each treatment period|Safety Analysis set - this outcome measure was not recorded in the Polysomnography testing||||||
2537182|NCT03141086|Secondary|Latency to Rapid Eye Movement (REM) Sleep Measured by Polysomnography (PSG)|"PSG encompasses the monitoring of subjects in a sleep facility using an array of medical equipment with simultaneously recording on a multi-channel analog or digital system. PSG was performed in the study to record and evaluate various aspects of sleep.~Sleep latency to REM Sleep is defined as the time from Lights-Off to reaching the first epoch (i.e. 30 seconds) of REM sleep."|Day 2 (midnight until 08:00) of each treatment period|Safety Analysis Set|||min||Standard Deviation|Mean
2537183|NCT03141086|Secondary|Number of Awakenings Measured by Polysomnography (PSG)|"PSG encompasses the monitoring of subjects in a sleep facility using an array of medical equipment with simultaneously recording on a multi-channel analog or digital system. PSG was performed in the study to record and evaluate various aspects of sleep.~Number of awakenings is defined as the number of times of entering wake stage after onset of sleep during the PSG recording."|Day 2 (midnight until 08:00) of each treatment period|Safety Analysis Set|||awakenings||Standard Deviation|Mean
2537184|NCT03141086|Secondary|Latency to Onset of Persisten Sleep Measured by Polysomnography (PSG)|PSG encompasses the monitoring of subjects in a sleep facility using an array of medical equipment with simultaneously recording on a multi-channel analog or digital system. PSG was performed in the study to record and evaluate various aspects of sleep. Latency to onset of persistent sleep is defined as latency from Lights-Off to the first epoch (30 seconds) of 20 consecutive epochs of non-Wake.|Day 2 (midnight until 08:00) of each treatment period|Safety Analysis Set|||min||Standard Deviation|Mean
2537185|NCT03141086|Secondary|Wake Time After Persistent Sleep Measured by Polysomnography (PSG)|"PSG encompasses the monitoring of subjects in a sleep facility using an array of medical equipment with simultaneously recording on a multi-channel analog or digital system. PSG was performed in the study to record and evaluate various aspects of sleep.~Wake time after persistent sleep is a measure of time spent awake after a defined onsep of sleep."|Day 2 (midnight until 08:00) of each treatment period|Safety Analysis Set|||min||Standard Deviation|Mean
2537186|NCT03141086|Secondary|Sleep Efficiency Measured by Polysomnography (PSG)|"PSG encompasses the monitoring of subjects in a sleep facility using an array of medical equipment with simultaneously recording on a multi-channel analog or digital system. PSG was performed in the study to record and evaluate various aspects of sleep.~Sleep efficiency is the percentage of time spent asleep during the entire PSG recording."|Day 2 (midnight until 08:00) of each treatment period|Safety Analysis Set|||percent||Standard Deviation|Mean
2537187|NCT03141086|Secondary|Sleep Time Measured by Polysomnography (PSG)|"PSG encompasses the monitoring of subjects in a sleep facility using an array of medical equipment with simultaneously recording on a multi-channel analog or digital system. PSG was performed in the study to record and evaluate various aspects of sleep.~Total sleep time is the overall duration of sleep during the entire PSG recording."|Day 2 (midnight until 08:00) of each treatment period|Safety Analysis Set|||min||Standard Deviation|Mean
2537188|NCT03141086|Secondary|Total Time in Bed Measured by Polysomnography (PSG)|"PSG encompasses the monitoring of subjects in a sleep facility using an array of medical equipment with simultaneously recording on a multi-channel analog or digital system. PSG was performed in the study to record and evaluate various aspects of sleep.~Total time in bed is the time spent in bed during recording."|Day 2 (midnight until 08:00) of each treatment period|Safety Analysis Set|||min||Standard Deviation|Mean
2537189|NCT03141086|Secondary|Plasma PK Concentration|Plasma PK concentration. Due to sparse sampling, only plasma concentrations were calculated and no PK parameter was evaluated by non-compartmental analysis.|0 to 34.5 hours post first treatment.|Pharmacokinetic analysis set (only analyzed for LML134 treatment period - not analyzed for Placebo period)|||ng/mL||Standard Deviation|Mean
2537190|NCT03141086|Secondary|Sleep Latency at Separate Naps Over Two Consecutive Test Nights as Measured by the the Multiple Sleep Latency Test (MSLT)|The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. Mean sleep latency from MSLT was measured for four MSLT naps performed at scheduled timepoints (01:30, 03:30, 05:30, and 07:30). The outcome measure is the mean value of Day 1 and Day 2 assessments for each timepoint.|Day 1 and Day 2 of each treatment period (midnight until 8:00)|Full analysis set|||min||Standard Deviation|Mean
2537191|NCT03141086|Primary|Mean Sleep Latency Over Two Consecutive Test Nights as Measured by the the Multiple Sleep Latency Test (MSLT)|The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient's ability to remain awake. Mean sleep latency from MSLT was measured for four MSLT naps performed at scheduled timepoints (01:30, 03:30, 05:30, and 07:30). The primary efficacy variable was the mean MSLT sleep latency assessed at Day 1 and Day 2 of each treatment period.|Day 1 and Day 2 of each treatment period (midnight until 8:00)|Full Analysis Set|||min||Standard Deviation|Mean
2537192|NCT03140631|Secondary|Count of Participants Who Experienced Vascular Access Site Complications|Secondary endpoints will include the number of patients who experience a 90-day occurrence of vascular access site complications defined as hematoma formation, aneurysm, pseudoaneurysm, arteriovenous fistula formation, access-site related major bleeding (defined as Bleeding Academic Research Consortium (BARC) type 3a or 5), or procedural intervention for access complications (surgical repair, thrombin injection, et cetera)|checked at 30 and 90 days||||Participants|||Count of Participants
2537193|NCT03140631|Primary|Time to Ambulation|Total length of time from procedural termination to patient ambulation|0 to 24 hours||||minutes||Standard Deviation|Mean
2537194|NCT03139578|Secondary|Monocular High Contrast Visual Acuity (VA)|Monocular high contrast distance VA with the study lenses was collected to the nearest letter using computer generated logMAR charts. 0.02 logMAR is equivalent to 1 letter. Negative logMAR values indicate better lens performance. The average visual acuity was reported for each lens type.|30-45 minutes after lens settling|All subjects who had successfully completed all required assessments without a major protocol deviation.|||logMAR|Eyes|Standard Deviation|Mean
2537195|NCT03139578|Secondary|Subjective Handling|Subjective handling was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely difficult and 10=very easy. The score ranges from 0 to 10, where higher scores indicate better handling. The average handling score for each lens was reported.|Immediately upon lens insertion|All subjects who had successfully completed all required assessments without a major protocol deviation.|||Graded scale 0-10|Eyes|Standard Deviation|Mean
2537196|NCT03139578|Secondary|Subjective Vision Quality|Subjective vision quality was assessed by the subject on an 11-point scale (0 to 10) where 0=extremely blurred and 10=perfect. The score ranges from 0 to 10, where higher scores indicate better vision quality. The average vision quality score for each lens was reported.|30-45 minutes after lens settling|All subjects who had successfully completed all required assessments without a major protocol deviation.|||Graded scale 0-10|Eyes|Standard Deviation|Mean
2537197|NCT03139578|Secondary|Subjective Comfort After Lens Settling|Subjective comfort on setting was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported.|30-45 minutes after lens settling|All subjects who had successfully completed all required assessments without a major protocol deviation.|||Graded scale 0-10|Eyes|Standard Deviation|Mean
2537198|NCT03139578|Secondary|Subjective Comfort at Lens Insertion|Subjective comfort on insertion was assessed by the subject on an 11-point scale (0 to 10) where 0=painful and 10=can't be felt. The score ranges from 0 to 10, where higher scores indicate better comfort. The average comfort score for each lens was reported.|Immediately upon lens insertion|All subjects who had successfully completed all required assessments without a major protocol deviation.|||Graded Scale 0-10|Eyes|Standard Deviation|Mean
2537249|NCT03138330|Secondary|Salivary Inflammatory Biomarkers|C-reactive protein, salivary IgA, alpha amylase|up to 1 month|Subjects who had sufficient saliva sample for analysis. There was not sufficient saliva sample to measure the CRP values, thus CRP values are not reported.|||ug/ml||Standard Deviation|Mean
2537199|NCT03139578|Primary|Lens Power Requirement|The lens power requirements (aka sphere requirements) for each lens type was calculated by summing the lens power and the spherical over-refraction. Then the difference of lens power requirement between the Test and Control lenses was calculated (Test-Control).|30-45 minutes after lens settling|All subjects who had successfully completed all required assessments without a major protocol deviation.|||Eyes|Eyes||Count of Units
2537200|NCT03139578|Primary|Overall Fit Acceptance|Overall lens fit acceptance was assessed by the investigator based on lens fitting characteristics and graded on a scale of 0 to 5, where 0=should not be worn and 5=perfect fit. The score ranges from 0 to 5, where higher scores indicate better fitting. The number of eye for each Grade was reported.|30-45 minutes after lens settling|All subjects who had successfully completed all required assessments visits without any a major protocol deviations.|||Eyes|Eyes||Count of Units
2537201|NCT03139552|Secondary|Ranking of Reduced Sugar Plus Spice Oatmeal|Subjects ranked each recipe in order of likability as first, second or third.|day of taste testing||||Participants|||Count of Participants
2537202|NCT03139552|Secondary|Ranking of Full Sugar Recipe of Oatmeal|Subjects ranked each recipe in order of likability as first, second or third.|day of taste testing||||Participants|||Count of Participants
2537203|NCT03139552|Secondary|Ranking of Reduced Sugar Recipe of Oatmeal|Subjects ranked each recipe in order of likability as first, second or third.|day of taste testing||||Participants|||Count of Participants
2537204|NCT03139552|Secondary|Ranking of Reduced Sugar Plus Spice Recipe of Tea|Subjects ranked each recipe in order of likability as first, second or third.|day of taste testing||||Participants|||Count of Participants
2537205|NCT03139552|Secondary|Ranking of Full Sugar Recipe of Tea|Subjects ranked each recipe in order of likability as first, second or third.|day of taste testing||||Participants|||Count of Participants
2537206|NCT03139552|Secondary|Ranking of Reduced Sugar Recipe of Tea|Subjects ranked each recipe in order of likability as first, second or third.|Day of taste testings||||Participants|||Count of Participants
2537207|NCT03139552|Secondary|Ranking of Reduced Sugar Plus Spice Recipe of Apple Crisp|Subjects ranked each recipe in order of likability as first, second or third.|day of taste testing||||Participants|||Count of Participants
2537208|NCT03139552|Secondary|Ranking of Reduced Sugar Recipe of Apple Crisp|Subjects ranked each recipe in order of likability as first, second or third.|day of taste testing||||Participants|||Count of Participants
2537209|NCT03139552|Secondary|Ranking of Full Sugar Recipe of Apple Crisp|Subjects ranked each recipe in order of likability as first, second or third.|day of taste testing||||Participants|||Count of Participants
2537210|NCT03139552|Primary|Overall Liking of Oatmeal|Overall liking of oatmeal with a 9-point hedonic rating scale instrument (whereby 0 = dislike extremely and 9 = like extremely )|day of taste testing||||score on a likert rating scale||Standard Deviation|Mean
2537211|NCT03139552|Primary|Overall Liking of Tea|Overall liking of tea with a 9-point hedonic rating scale instrument (whereby 0 = dislike extremely and 9 = like extremely )|day of taste testing||||score on a likert rating scale||Standard Deviation|Mean
2537212|NCT03139552|Primary|Overall Liking of Apple Crisp|Overall liking of apple crisp with a 9-point hedonic rating scale instrument (whereby 0 = dislike extremely and 9 = like extremely )|Day of taste testing||||score on likert rating scale||Standard Deviation|Mean
2537213|NCT03139448|Secondary|Minute Ventilation (MV)|Minute ventilation (MV)|Duration of colonoscopy procedure (usually 30 minutes)||||Liters per minute||Standard Deviation|Mean
2537214|NCT03139448|Secondary|Respiratory Rate (RR)|Respiratory Rate (RR)|Duration of colonoscopy procedure (usually 30 minutes)||||respiration per minute||Standard Deviation|Mean
2537215|NCT03139448|Secondary|Tidal Volume (VT)|Tidal volume (VT) defined as the volume of air displaced between inhalation and exhalation.|Duration of colonoscopy procedure (usually 30 minutes)||||milliliters||Standard Deviation|Mean
2537216|NCT03139448|Secondary|Number of Participants With Oxygen Saturation- Reading Below 90%|Number of participants with oxygen saturation- reading below 90%|Duration of colonoscopy procedure (usually 30 minutes)||||Participants|||Count of Participants
2537217|NCT03139448|Secondary|Oxygen Saturation- Lowest Reading|Oxygen saturation- Lowest reading|Duration of colonoscopy procedure (usually 30 minutes)||||percentage of oxygen saturation||Standard Deviation|Mean
2537218|NCT03139448|Secondary|Oxygen Saturation Reading- Median|Oxygen saturation reading- Median|Duration of colonoscopy procedure (usually 30 minutes)||||percentage of oxygen saturation||Inter-Quartile Range|Median
2537219|NCT03139448|Secondary|Duration of Intervention|Duration of intervention|Duration of colonoscopy procedure (usually 30 minutes)||||minutes||Standard Deviation|Mean
2537220|NCT03139448|Secondary|Number of Subjects Receiving Interventions for Airway Management|Number of subjects receiving interventions for airway management including chin up and/or jaw thrust, oral and/or nasal airway insertion, mask ventilation, intubation with endotracheal tube (ETT) or laryngeal mask airway (LMA) insertion|Duration of colonoscopy procedure (usually 30 minutes)||||Participants|||Count of Participants
2537221|NCT03139448|Primary|Time to First Intervention|The time period between the beginning of standard of care propofol bolus and/or start of propofol infusion to time of initiation of the first intervention for airway management.|Usually 5 minutes||||minutes||Standard Deviation|Mean
2537222|NCT03139279|Secondary|Number of Participants With Apneic Episodes Intraoperatively Requiring Positive Pressure Ventilation|Incidence of apneic episodes intraoperatively requiring positive pressure ventilation in each group|30 minutes||||Participants|||Count of Participants
2537223|NCT03139279|Secondary|Lowest Intraoperative % Change in MAP From Baseline|Lowest intraoperative percent (%) change in mean arterial pressure (MAP) from baseline (average in each group)|30 minutes||||percentage change||Inter-Quartile Range|Mean
2537224|NCT03139279|Secondary|Number of Participants With Sustained Bradycardic Episodes|Incidence of sustained bradycardic episodes (HR<50 for at least 5 minutes) intraoperatively in each group|30 minutes||||Participants|||Count of Participants
2537225|NCT03139279|Secondary|Average Total Propofol Consumption Per Group|Total propofol consumption per subject was measured as μg/kg/min of procedure in minutes. The average propofol consumption in each group will be measured as secondary outcome.|between 7 and 57 minutes (median 19 min)||||μg/kg/min||Inter-Quartile Range|Median
2537226|NCT03139279|Primary|Percentage of Subjects Ready for Discharge in Each Group at 30 Minutes Post Procedure|Each subject was assessed for readiness for discharge at 10, 20 and 30 minutes after the procedure, using the Modified Post-Anesthesia Discharge Scoring System (MPADSS). A subject getting an MPADS score of 9-10 is deemed ready for discharge. The percentage of subjects ready for discharge in each group at 10, 20 and 30 minutes will be measured as primary outcome.|30 minutes||||Participants|||Count of Participants
2537227|NCT03139240|Primary|7-10 Weeks Gestation - Maximum Self-reported Pain Score|Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).|24 hours after misoprostol administration|"Participants at 7-10w0d of Gestation were assessed. Participants who were lost to follow-up were excluded from this analysis."|||units on a scale||Full Range|Median
2537228|NCT03139240|Primary|<7 Weeks of Gestation - Maximum Self-reported Pain Score|Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).|24 hours after misoprostol administration|"Participants at <7 weeks of Gestation were assessed. Participants who were lost to follow-up were excluded from this analysis."|||units on a scale||Full Range|Median
2537229|NCT03139240|Primary|Overall Maximum Self-reported Pain Score|Women text responses through two surveys within 24 hours after misoprostol administration indicating their maximum self-reported pain score on an 11-point Numeric Pain Rating Scale (0 = no pain, 5 = moderate pain, and 10 = worst possible pain).|24 hours after misoprostol administration||||units on a scale||Full Range|Median
2537230|NCT03138967|Secondary|Overall Recovery Time|To determine if Sugammadex can improve overall recovery time, measured by time from end of surgery to the time patient met Discharge Criteria.|Up to 3 hours after end of surgery||||hours||Standard Deviation|Mean
2537231|NCT03138967|Secondary|PostOperative Complications|To determine if Sugammadex can improve post-operative complications for outpatient bladder procedures such as bladder perforation, nausea, vomiting, post-operative intubation and hospital admittance secondary to respiratory complications which was assessed uring follow ups on post-operative day 1 (POD1) and post-operative day 7 (POD7) looking for immediate postoperative complications such as bladder perforation, nausea, vomiting, postoperative intubation and hospital admittance secondary to respiratory complications and readmission within a week post-procedure for any other cause.|Post-operatively, up to 7 days||||Participants|||Count of Participants
2537232|NCT03138967|Primary|Muscle Recovery Time|The primary outcome is to determine if Sugammadex can improve muscle recovery time, measured by time from administration of neuromuscular blockade reversal to train-of-four ratio of 0.9 in outpatient bladder procedures. It was assessed in the intraoperative period measuring the time from administration of reversal agent to TOF of 0.9 in minutes.|Intraoperatively, up to 3 hours||||minutes||Standard Deviation|Mean
2537233|NCT03138876|Secondary|Number of Subjects for Which the EEG Cap and Standard EEG Results Are in Agreement for the Diagnosis of NCSE|Concordance between cap and standard-electrode diagnostic assessments|approximately 24 hours after completion of both tests||||Participants|||Count of Participants
2537234|NCT03138876|Secondary|Number of Subjects Diagnosed With NCSE|The number of subjects with suspected NCSE subsequently confirmed with NCSE after standard EEG.|approximately within 15 minutes after completion of test||||Participants|||Count of Participants
2537235|NCT03138876|Secondary|Percentage of Participants Whose EEG Cap Recordings Were Interpretable|The recording will be qualified as acceptable interpretation if greater than 50% of the recording is judged interpretable by board certified electroencephalographers.|approximately 15 minutes after completion of test||||Participants|||Count of Participants
2537236|NCT03138876|Primary|Time Difference Between EEG Cap and Standard EEG Results Reporting|The difference between EEG Cap results reporting time compared to Standard EEG results reporting time measured in minutes.|EEG order through 20 minutes of EEG recording time||||minutes||Standard Deviation|Mean
2537237|NCT03138798|Secondary|Number of NICU Admission|Neonatal outcomes: Number of neonatal intensive care unit (NICU) admissions|Day 1||||Participants|||Count of Participants
2537238|NCT03138798|Secondary|Neonatal Sex|Neonatal outcomes - Number of male neonatal sex|Day 1||||Participants|||Count of Participants
2537239|NCT03138798|Secondary|Neonatal Birth Weight|Neonatal outcomes - birth weight|Day 1||||grams||Standard Deviation|Mean
2537240|NCT03138798|Secondary|Number of Participants With Chorioamnionitis|Chorioamnionitis - an intra-amniotic infection (IAI) is an inflammation of the fetal membranes (amnion and chorion) due to a bacterial infection.|Day 1||||Participants|||Count of Participants
2537241|NCT03138798|Secondary|Number of Participants With Post-partum Hemorrhage|Number of participants with post-partum hemorrhage caused by uterine atony which is a loss of tone in the uterine musculature.|Day 1||||Participants|||Count of Participants
2537242|NCT03138798|Secondary|Estimated Blood Loss|Estimated blood loss (EBL) during delivery|Day 1||||mL||Inter-Quartile Range|Median
2537243|NCT03138798|Secondary|Mode of Delivery|Delivery Outcomes: Mode of delivery|Day 1||||Participants|||Count of Participants
2537244|NCT03138798|Secondary|Dental Support Device Comfort and Patient Satisfaction|After delivery patients assigned to the intervention group completed a comfort and satisfaction survey which consisted of three questions and given choices from strongly disagree to strongly agree|Post-Op Day 1|Only those who participated in survey was included|||Participants|||Count of Participants
2537245|NCT03138798|Primary|Delivery Time|The time from initiation of pushing until delivery during the second stage of labor. Intention to treat analysis will be performed.|An average of 75 minutes|Only those participants who delivered vaginally were included in the analysis|||minutes||Inter-Quartile Range|Median
2537246|NCT03138798|Primary|Dilation Duration of Second Stage of Labor Time|At the time of pushing in the second stage of labor, the time from full dilation to delivery during the second stage of labor in patients with vaginal delivery (spontaneous, vacuum, forceps included). Intention to treat analysis.|Up to 3 hours|Only participants who delivered vaginally were included in the analysis|||minutes||Inter-Quartile Range|Median
2537247|NCT03138382|Secondary|Change in Energy Expenditure (During VeNS)|Change in energy expenditure from baseline in kcal/min as measured using indirect calorimetry.|During middle 15 minutes of 45 minute vestibular nerve stimulation session||||kcal/min||Standard Deviation|Mean
2537250|NCT03138330|Primary|Validated Food Frequency Questionnaire|Ninety-one parents completed the sqFFQ and a 2-day weighed food record as the reference method. Intake of energy and nutrients (energy, carbohydrates, fat, protein, fibre, sugars, calcium and iron) were determined for each method and compared using Pearson correlations.|up to 1 month|Ninety-one parents of Singaporean toddlers who completed the sqFFQ and a 2-day weighed food record. Here pearson correlation between the two methods (FFQ and food diary) is presented.|||Pearson correlation|||Number
2537251|NCT03137784|Secondary|Mean Daily Number of Puffs of Rescue Medication During 1 Week of Treatment|A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours. daytime and nighttime (combined) number of puffs is defined as the average of the respective number of puffs.|Following 1 week of treatment|The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence|||Puffs/day||Standard Error|Least Squares Mean
2537252|NCT03137784|Secondary|Mean Evening Peak Expiratory Flow Rate (PEF) Following 1-week Treatment|A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits. LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates|Following 1 week of treatment|The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence|||L/min||Standard Error|Least Squares Mean
2537253|NCT03137784|Secondary|Mean Morning Peak Expiratory Flow (PEF) Following the 1-week Treatment Period|A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value|Following 1 week of treatment|The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence|||L/min||Standard Error|Least Squares Mean
2537254|NCT03137784|Secondary|Percent Change From Baseline in FEV1/FVC Ratio|To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of FEV1/FVC ratio following 1 week of treatment in respective treatment period|Following 1 week of treatment|The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence|||Percent change||Standard Deviation|Mean
2537255|NCT03137784|Secondary|Trough Forced Vital Capacity (FVC) After 1 Week of Treatment|To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of FVC following 1 week of treatment in respective treatment period. Trough Forced Vital Capacity (FVC) following 7 Days. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry|Following 1 week of treatment|The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence|||Liters||Standard Error|Least Squares Mean
2537256|NCT03137784|Secondary|Peak FEV1 During 4 Hours Post-dose After 1 Week of Treatment|To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of Peak FEV1 following 1 week of treatment in the respective treatment period. FEV1 was measured with spirometry conducted according to internationally accepted standards. The peak effect following 1 week of treatment was defined as the maximum FEV1 during the first 4 hour on that day.|Following 1 week of treatment|The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence|||Liters||Standard Error|Least Squares Mean
2537257|NCT03137784|Secondary|FEV1 AUC (5 Min - 23 h 45 Min) After One Week of Treatment|To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of Standardized FEV1 AUC following 1 week of treatment in the respective treatment period. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day AUC (5 min - 23 h 45 min)|Following 1 week of treatment|The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence.|||Liters||Standard Error|Least Squares Mean
2537286|NCT03136484|Secondary|Change in Biochemistry Parameter- Total Bilirubin|Change from baseline (week 0) to week 52 in total bilirubin (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Ratio of total bilirubin||Geometric Coefficient of Variation|Geometric Mean
2537258|NCT03137784|Secondary|FEV1 AUC (5 Min-4 h) After One Week of Treatment|To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of Standardized FEV1 AUC following 1 week of treatment in the respective treatment period. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 5min-4h)|Following 1 week of treatment|The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence.|||Liters||Standard Error|Least Squares Mean
2537259|NCT03137784|Secondary|FEV1 AUC (5 Min-1 h) After One Week of Treatment|To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared with placebo in terms of Standardized FEV1 AUC following 1 week of treatment in the respective treatment period. FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 5min-1h)|Following 1 week of treatment|The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence.|||Liters||Standard Error|Least Squares Mean
2537260|NCT03137784|Primary|Trough FEV1 After One Week of Treatment, Point Estimate|To evaluate the bronchodilator effects of NVA237 (25 ug and 50 ug) compared to placebo in terms of trough FEV1 (mean of 23h 15 min and 23 h 45 min post -dose) following 1 week of treatment in the respective treatment period. Trough FEV1 was assessed by performing spirometry measurements in the clinic for each treatment period. For the primary efficacy variable, trough FEV1 is the mean of two measurements taken at 23h 15 min and 23h 45 min post dose.|Following 1 week of treatment|The Full Analysis Set (FAS) consisted of all patients in the randomized Set (RAN) who received at least one dose of study medication. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence.|||Liters||Standard Error|Least Squares Mean
2537261|NCT03137225|Secondary|Average Pressures|Average mean airway pressure and peak inspiratory pressures required in each mode of ventilation.|8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode.|Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.||||||
2537262|NCT03137225|Secondary|Asynchronicity Counts|Overall asynchronicity counts will be determined by ventilator data that can be uploaded and analyzed with software supplied by the manufacturer.|During each four hour treatment segment|Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.||||||
2537263|NCT03137225|Secondary|Synchronicity|Synchronicity from the ventilator at the time of an event. This will be analyzed to determine whether asynchronicity is related to increased number of events during the study.|8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode.|Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.||||||
2537264|NCT03137225|Primary|Number of Unexpected Events|The number of isolated apneas, bradycardias and desaturations and the number of combined events will be compared by mode of ventilation.|8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode.|Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.||||||
2537265|NCT03136861|Secondary|Percentage of Participants With a Bath Ankylosing Spondylitis Disease Activity Index Score Below 4 at Week 8|The Bath ankylosing spondylitis disease activity index (BASDAI) consists of a 0 through 10 scale, which is used to answer 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis. To give each symptom equal weighting, the mean (average) of the 2 scores relating to morning stiffness (questions 5 and 6) is taken. The mean of questions 5 and 6 is added to the scores from questions 1-4. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score.|Week 8|Full Analysis Set (FAS) in Treatment Period 1.|||Participants|||Count of Participants
2537266|NCT03136861|Primary|Percentage of Participants With a Spinal Pain Numerical Rating Scale (NRS) Score Below 4 at Week 8|The spinal pain numerical rating scale (NRS) is an 11-point scale to assess pain intensity in patients who are able to self-report. To calculate the average spinal pain, the patient is asked to answer 2 questions to get 2 pain ratings, the total spinal pain corresponding to the intensity of spinal pain experienced on an average over 24 hours during the previous week and the nocturnal back pain corresponding to the intensity of spinal pain experienced on an average over the night during the previous week.|Week 8|Full Analysis Set (FAS) in Treatment Period 1.|||Participants|||Count of Participants
2537267|NCT03136484|Secondary|Change in CoEQ: Individual Items|The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control', 'craving for sweet', 'craving for savoury' and 'positive mood'. The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the 'on-treatment without rescue medication' observation period.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Score on a scale||Standard Deviation|Mean
2537275|NCT03136484|Secondary|Eye Examination|Fundus photography or a dilated fundoscopy was performed by the investigator at baseline (week 0) and week 52. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at baseline and week 52 were presented. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Participants|||Count of Participants
2537268|NCT03136484|Secondary|Change in Control of Eating Questionnaire (CoEQ): Domains|The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control', 'craving for sweet', 'craving for savoury' and 'positive mood'. The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the 'on-treatment without rescue medication' observation period.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Score on a scale||Standard Deviation|Mean
2537269|NCT03136484|Secondary|Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately|"Change from baseline (week 0) in DTSQ was evaluated at week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the 'on-treatment without rescue medication' observation period."|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Score on a scale||Standard Deviation|Mean
2537270|NCT03136484|Secondary|Change in SF-36: Mental Component Summary (MCS)|Change from baseline (week 0) to week 52 in short form 36 v2.0 acute domain MCS. SF- 36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Results are based on the 'on-treatment without rescue medication' observation period.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Score on a scale||Standard Deviation|Mean
2537271|NCT03136484|Secondary|Change in SF-36: Physical Component Summary (PCS)|Change from baseline (week 0) to week 52 in short form 36 v2.0 acute domain PCS. SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. It consists of 2 component summary measures that further summarize 8 health domain scales. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Results are based on the 'on-treatment without rescue medication' observation period.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Score on a scale||Standard Deviation|Mean
2537272|NCT03136484|Secondary|Change in Short Form 36 Health Survey (SF-36): Sub-domains|SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline (week 0) to week 52 in the sub-domain scores is presented. A positive change score indicate an improvement since baseline. Results are based on the 'on-treatment without rescue medication' observation period.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Score on a scale||Standard Deviation|Mean
2537273|NCT03136484|Secondary|Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes|Number of participants with treatment emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes. Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Weeks 0-57|Safety analysis set comprised of participants exposed to at least one dose of trial product.|||Participants|||Number
2537274|NCT03136484|Secondary|Total Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes|Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Weeks 0-57|Safety analysis set comprised of participants exposed to at least one dose of trial product.|||Episodes|||Number
2537479|NCT03133481|Secondary|Mean Opioid Consumption as Measured in Oral Morphine Milligram Equivalents|Mean opioid consumption as measured immediately post operatively from Anesthesia Record Stop Time to 4 hours after Anesthesia Record Stop Time in Oral Morphine Milligram Equivalents|Post operatively through 4 hours||||Oral Morphine Milligram Equivalents||Standard Deviation|Mean
2537276|NCT03136484|Secondary|Change in Physical Examination|Physical examination parameters are categorised as general appearance; nervous system (central and peripheral); cardiovascular system; gastrointestinal system; skin; respiratory system; lymph node palpation; thyroid gland; left foot; right foot; left leg and right leg. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -2) and week 52 is presented based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week -2, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Participants|||Count of Participants
2537277|NCT03136484|Secondary|Change in ECG|The electrocardiogram (ECG) was assessed by the investigator at baseline (week 0) and week 52 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 52 were presented. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Participants|||Count of Participants
2537278|NCT03136484|Secondary|Change in Pulse|Change from baseline (week 0) to week 52 in pulse is presented based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Beats per minute (beats/min)||Standard Deviation|Mean
2537279|NCT03136484|Secondary|Change in Calcitonin|Change from baseline (week 0) to week 52 in calcitonin (nanograms per liter) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Ratio of calcitonin||Geometric Coefficient of Variation|Geometric Mean
2537280|NCT03136484|Secondary|Change in Biochemistry Parameter- Sodium|Change from baseline (week 0) to week 52 in sodium (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Ratio of sodium||Geometric Coefficient of Variation|Geometric Mean
2537281|NCT03136484|Secondary|Change in Biochemistry Parameter- Potassium|Change from baseline (week 0) to week 52 in potassium (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Ratio of potassium||Geometric Coefficient of Variation|Geometric Mean
2537282|NCT03136484|Secondary|Change in Biochemistry Parameter- Calcium|Change from baseline (week 0) to week 52 in calcium (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Ratio of calcium||Geometric Coefficient of Variation|Geometric Mean
2537283|NCT03136484|Secondary|Change in Biochemistry Parameter- Albumin|Change from baseline (week 0) to week 52 in albumin (g/dL) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Ratio of albumin||Geometric Coefficient of Variation|Geometric Mean
2537284|NCT03136484|Secondary|Change in Biochemistry Parameter- eGFR|Estimated glomerular filtration rate (eGFR) (milliliters per minute per 1.73 square meters [mL/min/1.73m^2])is calculated using the equation from the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). Change from baseline (week 0) to week 52 in eGFR is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Ratio of eGFR||Geometric Coefficient of Variation|Geometric Mean
2537285|NCT03136484|Secondary|Change in Biochemistry Parameter- Creatinine|Change from baseline (week 0) to week 52 in creatinine (micromoles per liter [umol/L]) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Ratio of creatinine||Geometric Coefficient of Variation|Geometric Mean
2537391|NCT03136068|Secondary|Measured Blood Loss|measured blood loss, in mL, during the procedure, measured by weighing the absorbent materials used and subtracting out their weight without blood|Day 2, during the procedure|measured blood loss was only completed at the Zuckerberg San Francisco General Hospital location, which is why the total is 61 rather than 175 for this outcome|||mL||Inter-Quartile Range|Median
2537287|NCT03136484|Secondary|Change in Biochemistry Parameter- ALP|Change from baseline (week 0) to week 52 in alkaline phosphatase (ALP) (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Ratio of ALP||Geometric Coefficient of Variation|Geometric Mean
2537288|NCT03136484|Secondary|Change in Biochemistry Parameter- AST|Change from baseline (week 0) to week 52 in aspartate aminotransferase (AST) (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Ratio of AST||Geometric Coefficient of Variation|Geometric Mean
2537289|NCT03136484|Secondary|Change in Biochemistry Parameter- ALT|Change from baseline (week 0) to week 52 in alanine aminotransferase (ALT) (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Ratio of ALT||Geometric Coefficient of Variation|Geometric Mean
2537290|NCT03136484|Secondary|Change in Biochemistry Parameter- Lipase|Change from baseline (week 0) to week 52 in lipase (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Ratio of lipase||Geometric Coefficient of Variation|Geometric Mean
2537291|NCT03136484|Secondary|Change in Biochemistry Parameter- Amylase|Change from baseline (week 0) to week 52 in amylase (units per liter [U/L]) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Ratio of amylase||Geometric Coefficient of Variation|Geometric Mean
2537292|NCT03136484|Secondary|Change in Haematological Parameter- Thrombocytes|Change from baseline (week 0) to week 52 in thrombocytes (10^9 cells/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Ratio of thrombocytes||Geometric Coefficient of Variation|Geometric Mean
2537293|NCT03136484|Secondary|Change in Haematological Parameter- Leukocytes|Change from baseline (week 0) to week 52 in leukocytes (10^9 cells/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Ratio of leukocytes||Geometric Coefficient of Variation|Geometric Mean
2537294|NCT03136484|Secondary|Change in Haematological Parameter- Erythrocytes|Change from baseline (week 0) to week 52 in erythrocytes (10^12 cells/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Ratio of erythrocytes||Geometric Coefficient of Variation|Geometric Mean
2537295|NCT03136484|Secondary|Change in Haematological Parameter- Haematocrit|Change from baseline (week 0) to week 52 in haematocrit (%) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Ratio of haematocrit||Geometric Coefficient of Variation|Geometric Mean
2537296|NCT03136484|Secondary|Change in Haematological Parameter- Haemoglobin|Change from baseline (week 0) to week 52 in haemoglobin (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any.|Week 0, week 52|"Safety analysis set comprised of participants exposed to at least one dose of trial product. Number analyzed=participants with available data."|||Ratio of haemoglobin||Geometric Coefficient of Variation|Geometric Mean
2537297|NCT03136484|Secondary|Total Number of Treatment Emergent Adverse Events (TEAEs)|A TEAE is defined as an adverse event with onset in the on-treatment observation period (which started at the date of first dose of trial product and included the period after initiation of rescue medication, if any and excluded the period after premature trial product discontinuation, if any. TEAEs assessed up to approximately 57 weeks is presented.|Weeks 0-57|Safety analysis set comprised of participants exposed to at least one dose of trial product.|||Adverse events|||Number
2537518|NCT03131999|Secondary|Adverse Events|Adverse event and Serious Adverse Event numbers using the CTCAE Version 4.03 definitions|3 months|||||||
2537298|NCT03136484|Secondary|Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥10% (Yes/no)|Percentage of participants who achieved ≥1% reduction of baseline HbA1c and losing ≥10% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Percentage of participants|||Number
2537299|NCT03136484|Secondary|Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥5% (Yes/no)|Percentage of participants who achieved ≥1% reduction of baseline HbA1c and losing ≥5% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Percentage of participants|||Number
2537300|NCT03136484|Secondary|Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥3% (Yes/no)|Percentage of participants who achieved ≥1% reduction of baseline HbA1c and losing ≥3% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Percentage of participants|||Number
2537301|NCT03136484|Secondary|Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/no)|Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 milligrams per deciliter [mg/dL]) with symptoms consistent with hypoglycaemia. Percentage of participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Percentage of participants|||Number
2537302|NCT03136484|Secondary|Participants Who Achieved Weight Loss ≥10% (Yes/no)|Percentage of participants losing ≥10% of baseline body weight is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Percentage of participants|||Number
2537303|NCT03136484|Secondary|Participants Who Achieved Weight Loss ≥5% (Yes/no)|Percentage of participants losing ≥5% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Percentage of participants|||Number
2537304|NCT03136484|Secondary|Participants Who Achieved Weight Loss ≥3% (Yes/no)|Percentage of participants losing ≥3% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Percentage of participants|||Number
2537305|NCT03136484|Secondary|Participants Who Achieved HbA1c Reduction ≥1% (Yes/no)|Percentage of participants who achieved ≥1% reduction of baseline HbA1c (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Percentage of participants|||Number
2537306|NCT03136484|Secondary|Participants Who Achieved HbA1c ≤ 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target (Yes/no)|Percentage of participants who achieved HbA1c ≤ 6.5% (48 mmol/mol), AACE target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Percentage of participants|||Number
2537307|NCT03136484|Secondary|Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target (Yes/no)|Percentage of participants who achieved HbA1c < 7.0% (53 millimoles per mole [mmol/mol]), ADA target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Percentage of participants|||Number
2537308|NCT03136484|Secondary|Change in Ratio Between Total Fat Mass and Total Lean Mass|Change from baseline (week 0) to week 52 in ratio between total fat mass and total lean mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"DXA analysis set comprised of all randomised participants who are included in the body composition sub-study. Number analyzed=participants with available data."|||total fat mass/total lean mass ratio||Standard Deviation|Mean
2537519|NCT03131999|Primary|Serum VEGF-D|Change in the square root of the intrasubject plasma VEGF-D|Before and 1 month after initiation of monotherapy imatinib mesylate or placebo||||Log transformed VEGF-D change pg/dL||Standard Deviation|Mean
2537309|NCT03136484|Secondary|Percentage Change in Visceral Fat Mass (%)|Change from baseline (week 0) to week 52 in visceral fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"DXA analysis set comprised of all randomised participants who are included in the body composition sub-study. Number analyzed=participants with available data."|||Percentage change||Standard Deviation|Mean
2537310|NCT03136484|Secondary|Change in Visceral Fat Mass (kg)|Change from baseline (week 0) to week 52 in visceral fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"DXA analysis set comprised of all randomised participants who are included in the body composition sub-study. Number analyzed=participants with available data."|||kg||Standard Deviation|Mean
2537311|NCT03136484|Secondary|Percentage Change in Total Lean Mass (%)|Change from baseline (week 0) to week 52 in total lean mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"DXA analysis set comprised of all randomised participants who are included in the body composition sub-study. Number analyzed=participants with available data."|||Percentage change||Standard Deviation|Mean
2537312|NCT03136484|Secondary|Change in Total Lean Mass (kg)|Change from baseline (week 0) to week 52 in total lean mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"DXA analysis set comprised of all randomised participants who are included in the body composition sub-study. Number analyzed=participants with available data."|||kg||Standard Deviation|Mean
2537313|NCT03136484|Secondary|Percentage Change in Total Fat Mass (%)|Change from baseline (week 0) to week 52 in total fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"DXA analysis set comprised of all randomised participants who are included in the body composition sub-study. Number analyzed=participants with available data."|||Percentage change||Standard Deviation|Mean
2537314|NCT03136484|Secondary|Change in Waist Circumference|Change from baseline (week 0) to week 52 in waist circumference was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Centimeter (cm)||Standard Deviation|Mean
2537315|NCT03136484|Secondary|Change in Body Mass Index (BMI)|Change from baseline (week 0) to week 52 in BMI was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Kilogram per square meter (kg/m^2)||Standard Deviation|Mean
2537316|NCT03136484|Secondary|Percentage Change in Body Weight (%)|Change from baseline (week 0) to week 52 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Percentage change||Standard Deviation|Mean
2537317|NCT03136484|Secondary|Change in Vital Signs (Systolic Blood Pressure and Diastolic Blood Pressure)|Change from baseline (week 0) to week 52 in systolic blood pressure and diastolic blood pressure. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2537318|NCT03136484|Secondary|Change in Fasting Triglycerides|Change from baseline (week 0) to week 52 in fasting triglycerides (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Ratio of triglycerides||Geometric Coefficient of Variation|Geometric Mean
2537319|NCT03136484|Secondary|Change in Fasting HDL-cholesterol|Change from baseline (week 0) to week 52 in fasting high-density lipoprotein (HDL) cholesterol (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Ratio of HDL-cholesterol||Geometric Coefficient of Variation|Geometric Mean
2537320|NCT03136484|Secondary|Change in Fasting LDL-cholesterol|Change from baseline (week 0) to week 52 in fasting low-density lipoprotein (LDL) cholesterol (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Ratio of LDL-cholesterol||Geometric Coefficient of Variation|Geometric Mean
2537392|NCT03136068|Secondary|Total Procedure Duration|Time from speculum placed until all instruments removed from vagina (including speculum and fingers) and done with everything|done on Day 2 during the procedure|duration of procedure for each participant from insertion of speculum to total procedure completion, including any post-procedure activities prior to being taken to recovery|||minutes||Standard Deviation|Mean
2537321|NCT03136484|Secondary|Change in Fasting Total Cholesterol|Change from baseline (week 0) to week 52 in fasting total cholesterol (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Ratio of total cholesterol||Geometric Coefficient of Variation|Geometric Mean
2537322|NCT03136484|Secondary|Change in SMPG- Mean Postprandial Increment Over All Meals|Change from baseline (week 0) to week 52 in SMPG- mean postprandial increment over all meals was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||mmol/L||Standard Deviation|Mean
2537323|NCT03136484|Secondary|Change in SMPG (Self-measured Plasma Glucose)- Mean 7-point Profile|Change from baseline (week 0) to week 52 in SMPG- mean 7-point profile was evaluated. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||mmol/L||Standard Deviation|Mean
2537324|NCT03136484|Secondary|Change in FPG (Fasting Plasma Glucose)|Change from baseline (week 0) to week 52 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2537325|NCT03136484|Secondary|Change in Total Fat Mass (kg)|Change from baseline (week 0) to week 52 in total fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Dual X-ray absorptiometry (DXA) analysis set comprised of all randomised participants who are included in the body composition sub-study. Number analyzed=participants with available data."|||kg||Standard Deviation|Mean
2537326|NCT03136484|Secondary|Change in Body Weight (kg)|Change from baseline (week 0) to week 52 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Kilogram (kg)||Standard Deviation|Mean
2537327|NCT03136484|Primary|Change in HbA1c|Change from baseline (week 0) to week 52 in HbA1c (glycosylated haemoglobin) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first; and 'In-trial' observation period which started at the date of randomisation and include the period after initiation of rescue medication and/or premature trial product discontinuation, if any and ended at the last contact, withdrawal of consent or death, whichever came first.|Week 0, week 52|"Full analysis set comprised of all randomised participants. Number analyzed=participants with available data."|||Percentage (%) of HbA1c||Standard Deviation|Mean
2537328|NCT03136380|Primary|Tlast of the Blood Concentration of GSK1325756H for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 post-dose in Part 2|PK Population|||Hours||Full Range|Median
2537329|NCT03136380|Primary|Tlag of GSK1325756H for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2|PK Population|||Hours||Full Range|Median
2537330|NCT03136380|Primary|t1/2 of GSK1325756H for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. Only those participants with data available at the indicated time points were analyzed.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2|PK Population|||Hours||Standard Deviation|Mean
2537331|NCT03136380|Primary|Tmax of GSK1325756H for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2|PK Population|||Hours||Full Range|Median
2537332|NCT03136380|Primary|AUC (0-24) of GSK1325756H for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2|PK Population|||Hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2537393|NCT03136068|Primary|Procedure Duration|First instrument into uterus until procedure complete|Beginning to end of procedure (between 5 minutes and 1 hour)|Duration of procedure time from speculum insertion to procedure completion|||minutes||Standard Deviation|Mean
2537333|NCT03136380|Primary|AUC (0-inf) of GSK1325756H for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. Only those participants with data available at the indicated time points were analyzed.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2|PK Population|||Hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2537334|NCT03136380|Primary|AUC (0-t) of GSK1325756H for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2|PK Population|||Hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2537335|NCT03136380|Primary|Cmax of GSK1325756H for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2|PK Population|||Nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2537336|NCT03136380|Primary|Time to Last Quantifiable Concentration (Tlast) of the Blood Concentration of GSK1325756H for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1|PK Population|||Hours||Full Range|Median
2537337|NCT03136380|Primary|Lag Time Before Observable Concentration (Tlag) of GSK1325756H for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756 in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1|PK Population|||Hours||Full Range|Median
2537338|NCT03136380|Primary|Terminal Half-life (t1/2) of GSK1325756H for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756 in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1|PK Population|||Hours||Standard Deviation|Mean
2537339|NCT03136380|Primary|Time to Maximum Observed Concentration (Tmax) of GSK1325756H for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1|PK Population|||Hours||Full Range|Median
2537340|NCT03136380|Primary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC [0-24]) of GSK1325756H for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1|PK Population|||Hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2537341|NCT03136380|Primary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC [0-inf]) of GSK1325756H for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1|PK Population|||Hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2537342|NCT03136380|Primary|Area Under the Concentration-time Curve From Time 0 to t (AUC [0-t]) of GSK1325756H for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1|PK Population|||Hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2537343|NCT03136380|Primary|Maximum Observed Concentration (Cmax) of GSK1325756H for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of GSK1325756H in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1|PK Population|||Nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2537344|NCT03136380|Primary|Blood Concentration of GSK1325756 in Part 2|Whole blood samples of approximately 1 milliliters were collected for measurement of blood concentrations of GSK1325756 at Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in part 1. Data has been presented for blood concentrations of GSK1325756 in fasted and fed state. NA indicates standard deviation could not be calculated due to high proportion of NQ values (more than 30% of values were imputed i.e., NQ assigned zero concentration) which affected the standard deviation.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post-dose in Part 2|PK Population|||Nanograms/milliliter||Standard Deviation|Mean
2537345|NCT03136380|Primary|Blood Concentration of GSK1325756 in Part 1|Whole blood samples of approximately 1 milliliters were collected for measurement of blood concentrations of GSK1325756 at pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of part 1. Data has been presented for blood concentrations of GSK1325756 in fed state. Pharmacokinetic (PK) population was defined as participants who were administered at least one dose of study treatment and who had PK sample taken and analyzed. NA indicates standard deviation could not be calculated due to high proportion of non-quantifiable [NQ] values (more than 30% of values were imputed i.e., NQ assigned zero concentration) which affected the standard deviation and no sample was obtained per protocol for 60 and 72 hours.|Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours in all 3 periods; 60 and 72 hours post-dose in period-3 of Part 1|PK Population|||Nanograms/milliliter||Standard Deviation|Mean
2537346|NCT03136380|Primary|Change From Baseline in Electrocardiogram Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT (Frederica's Correction) Interval for Part 2|Single 12-lead ECG's were obtained from Baseline and up to 72 hours in Part 2 using an ECG machine that automatically calculated the heart rate and measured PR Interval, QRS Duration, Uncorrected QT interval and Corrected QT (Frederica's correction) interval. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.|Baseline and up to 48 hours in Part 2|Safety Population|||Milliseconds||Standard Deviation|Mean
2537347|NCT03136380|Primary|Change From Baseline in Electrocardiogram (ECG) Parameters PR Interval, QRS Duration, Uncorrected QT Interval and Corrected QT Frederica's Correction) Interval|Single 12-lead ECG's were obtained from Baseline and up to 72 hours in Part 1 using an ECG machine that automatically calculated the heart rate and measured PR Interval, QRS Duration, Uncorrected QT interval and Corrected QT (Fridericia's correction) interval. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 72 hours in Part 1|Safety Population|||Milliseconds||Standard Deviation|Mean
2537348|NCT03136380|Primary|Change From Baseline in Vital Sign Parameter Temperature for Part 2|Vital sign measurements included temperature at Baseline and up to 72 hours in Part 2. Temperature measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions and were measured in a supine position after 5 minutes rest. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.|Baseline and up to 48 hours in Part 2|Safety Population|||Degree Celsius||Standard Deviation|Mean
2537349|NCT03136380|Primary|Change From Baseline in Vital Sign Parameter Heart Rate for Part 2|Vital sign measurements included heart rate at Baseline and up to 72 hours in Part 2. Heart rate measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions and were measured in a supine position after 5 minutes rest. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.|Baseline and up to 48 hours in Part 2|Safety Population|||Beats per minute||Standard Deviation|Mean
2537350|NCT03136380|Primary|Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2|Vital sign measurements included SBP and DBP at Baseline and up to 72 hours in Part 2. SBP and DBP measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions and were measured in a supine position after 5 minutes rest. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.|Baseline and up to 48 hours in Part 2|Safety Population|||Millimeters of mercury||Standard Deviation|Mean
2537351|NCT03136380|Primary|Change From Baseline in Vital Sign Parameter Temperature for Part 1|Vital sign measurements included temperature at Baseline and up to 72 hours in Part 1. Temperature measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions and were measured in a supine position after 5 minutes rest. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 72 hours in Part 1|Safety Population|||Degree Celsius||Standard Deviation|Mean
2537352|NCT03136380|Primary|Change From Baseline in Vital Sign Parameter Heart Rate for Part 1|Vital sign measurements included heart rate at Baseline and up to 72 hours in Part 1. Heart rate measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions and were measured in a supine position after 5 minutes rest. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 72 hours in Part 1|Safety Population|||Beats per minute||Standard Deviation|Mean
2537353|NCT03136380|Primary|Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1|Vital sign measurements included SBP and DBP at Baseline and up to 72 hours in Part 1. SBP and DBP measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions and were measured in a supine position after 5 minutes rest. Baseline was defined as pre-dose assessments performed on Day 1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 72 hours in Part 1|Safety Population|||Millimeters of mercury||Standard Deviation|Mean
2537354|NCT03136380|Primary|Urine Specific Gravity Analysis by Dipstick Method for Part 2|Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up to 48 hours in Part 2. Density is the mass per unit volume and has units (such as g/cm^3), however, the specific gravity is a ratio so it has no unit.|Up to 72 hours in Part 2|Safety Population|||Ratio||Standard Deviation|Mean
2537355|NCT03136380|Primary|Urine pH Analysis by Dipstick Method for Part 2|Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by dipstick method up to 48 hours in Part 2.|Up to 48 hours in Part 2|Safety Population|||pH||Standard Deviation|Mean
2537356|NCT03136380|Primary|Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2|Urinalysis parameters assessed were urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen. In this dipstick test, the level of bilirubin, occult blood, glucose, ketones, urine protein and urobilinogen in urine samples was recorded as negative, trace and +. Urine samples were collected for the measurement of urinalysis parameters by dipstick method up to 48 hours in Part 2. Only categories with significant values have been presented.|Up to 48 hours in Part 2|Safety Population|||Participants|||Number
2537357|NCT03136380|Primary|Urine Specific Gravity Analysis by Dipstick Method for Part 1|Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up to 72 hours in Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Density is the mass per unit volume and has units (such as g/cm^3), however, the specific gravity is a ratio so it has no unit.|Up to 72 hours in Part 1|Safety Population|||Ratio||Standard Deviation|Mean
2537358|NCT03136380|Primary|Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part 1|Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by method up to 72 hours in Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Up to 72 hours in Part 1|Safety Population|||pH||Standard Deviation|Mean
2537359|NCT03136380|Primary|Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1|Urinalysis parameters assessed were urine bilirubin, urine occult blood, urine glucose, urine ketones, urine protein and urine urobilinogen. In this dipstick test, the level of bilirubin, occult blood, glucose, ketones, urine protein and urobilinogen in urine samples was recorded as negative, trace and +. Urine samples were collected for the measurement of urinalysis parameters by dipstick method up to 72 hours in Part 1. Only categories with significant values have been presented.|Up to 72 hours in Part 1|Safety Population|||Participants|||Number
2537360|NCT03136380|Primary|Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 2|Blood samples were collected for the assessment of hematology parameters namely red blood count and reticulocyte count for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.|Baseline and up to 48 hours in Part 2|Safety Population|||Trillion cells/liter||Standard Deviation|Mean
2537361|NCT03136380|Primary|Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 2|Blood samples were collected for the assessment of hematology parameters namely platelet count and white blood cell count for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.|Baseline and up to 48 hours in Part 2|Safety Population|||Giga cells/liter||Standard Deviation|Mean
2537362|NCT03136380|Primary|Change From Baseline in Hematology Parameter Mean Corpuscle Volume for Part 2|Blood samples were collected for the assessment of hematology parameter namely mean corpuscle volume for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.|Baseline and up to 48 hours in Part 2|Safety Population|||Femtoliters||Standard Deviation|Mean
2537363|NCT03136380|Primary|Change From Baseline in Hematology Parameter Mean Corpuscle Hemoglobin for Part 2|Blood samples were collected for the assessment of hematology parameter namely mean corpuscle hemoglobin for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.|Baseline and up to 48 hours in Part 2|Safety Population|||Picograms||Standard Deviation|Mean
2537364|NCT03136380|Primary|Change From Baseline in Hematology Parameter Hematocrit for Part 2|Blood samples were collected for the assessment of hematology parameter namely hematocrit for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.|Baseline and up to 48 hours in Part 2|Safety Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
2537365|NCT03136380|Primary|Change From Baseline in Hematology Parameter Hemoglobin for Part 2|Blood samples were collected for the assessment of hematology parameter namely hemoglobin for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.|Baseline and up to 48 hours in Part 2|Safety Population|||Grams/liter||Standard Deviation|Mean
2537366|NCT03136380|Primary|Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 2|Blood samples were collected for the assessment of hematology parameters namely basophils, eosinophils, leukocytes, lymphocytes, monocytes, total neutrophils and platelets for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.|Baseline and up to 48 hours in Part 2|Safety Population|||Percentage of cells||Standard Deviation|Mean
2537379|NCT03136380|Primary|Change From Baseline in Clinical Chemistry Parameter Amylase for Part 1|Blood samples were collected for the assessment of chemistry parameters namely amylase for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 72 hours in Part 1|Safety Population|||Units/liter||Standard Deviation|Mean
2537367|NCT03136380|Primary|Change From Baseline in Hematology Parameters Red Blood Count and Reticulocyte Count for Part 1|Blood samples were collected for the assessment of hematology parameters namely red blood count and reticulocyte count for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 72 hours in Part 1|Safety Population|||Trillion cells/liter||Standard Deviation|Mean
2537368|NCT03136380|Primary|Change From Baseline in Hematology Parameters Platelet Count and White Blood Cell Count for Part 1|Blood samples were collected for the assessment of hematology parameters namely platelet count and white blood cell count for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 72 hours in Part 1|Safety Population|||Giga cells/liter||Standard Deviation|Mean
2537369|NCT03136380|Primary|Change From Baseline in Hematology Parameter Mean Corpuscle Volume for Part 1|Blood samples were collected for the assessment of hematology parameter namely mean corpuscle volume for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 72 hours in Part 1|Safety Population|||Femtoliters||Standard Deviation|Mean
2537370|NCT03136380|Primary|Change From Baseline in Hematology Parameter Mean Corpuscle Hemoglobin for Part 1|Blood samples were collected for the assessment of hematology parameter namely mean corpuscle hemoglobin for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 72 hours in Part 1|Safety Population|||Picograms||Standard Deviation|Mean
2537371|NCT03136380|Primary|Change From Baseline in Hematology Parameter Hematocrit for Part 1|Blood samples were collected for the assessment of hematology parameter namely hematocrit for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 72 hours in Part 1|Safety Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
2537372|NCT03136380|Primary|Change From Baseline in Hematology Parameter Hemoglobin for Part 1|Blood samples were collected for the assessment of hematology parameter namely hemoglobin for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 72 hours in Part 1|Safety Population|||Grams/liter||Standard Deviation|Mean
2537373|NCT03136380|Primary|Change From Baseline in Hematology Parameters Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils for Part 1|Blood samples were collected for the assessment of hematology parameters namely basophils, eosinophils, leukocytes, lymphocytes, monocytes, total neutrophils and platelets for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 72 hours in Part 1|Safety Population|||Percentage of cells||Standard Deviation|Mean
2537374|NCT03136380|Primary|Change From Baseline in Clinical Chemistry Parameter Amylase for Part 2|Blood samples were collected for the assessment of chemistry parameter namely amylase for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.|Baseline and up to 48 hours in Part 2|Safety Population|||Units/liter||Standard Deviation|Mean
2537375|NCT03136380|Primary|Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 2|Blood samples were collected for the assessment of chemistry parameters namely direct bilirubin, total bilirubin, creatinine and uric acid for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.|Baseline and up to 48 hours in Part 2|Safety Population|||Micromoles/liter||Standard Deviation|Mean
2537376|NCT03136380|Primary|Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 2|Blood samples were collected for the assessment of chemistry parameters namely albumin and total protein for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.|Baseline and up to 48 hours in Part 2|Safety Population|||Grams/liter||Standard Deviation|Mean
2537377|NCT03136380|Primary|Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, ALT, AST, Creatine Kinase, GGT and Lactate Dehydrogenase for Part 2|Blood samples were collected for the assessment of chemistry parameters namely alkaline phosphatase, ALT, AST, creatine kinase, GGT and lactate dehydrogenase for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.|Baseline and up to 48 hours in Part 2|Safety Population|||International units/liter||Standard Deviation|Mean
2537378|NCT03136380|Primary|Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, HDL Cholesterol, Potassium, LDL Cholesterol, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN for Part 2|Blood samples were collected for the assessment of chemistry parameters namely calcium, cholesterol, chloride, glucose, HDL cholesterol, potassium, LDL cholesterol, sodium, phosphorus, triglycerides, urea/BUN results for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value.|Baseline and up to 48 hours in Part 2|Safety Population|||Millimoles/liter||Standard Deviation|Mean
2537389|NCT03136068|Secondary|Complications|hemorrhage, perforation, cervical laceration requiring suture repair, out-of-hospital delivery, infection, inability to complete injection, other complications of the injection itself, and patient symptoms such as nausea and vomiting|Day 2|any complication reported by patient; may have reported more than one complication|||Participants|||Count of Participants
2537380|NCT03136380|Primary|Change From Baseline in Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid for Part 1|Blood samples were collected for the assessment of chemistry parameters namely direct bilirubin, total bilirubin, creatinine and uric acid for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 72 hours in Part 1|Safety Population|||Micromoles/liter||Standard Deviation|Mean
2537381|NCT03136380|Primary|Change From Baseline in Clinical Chemistry Parameters Albumin and Total Protein for Part 1|Blood samples were collected for the assessment of chemistry parameters namely albumin and total protein for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 72 hours in Part 1|Safety Population|||Grams/liter||Standard Deviation|Mean
2537382|NCT03136380|Primary|Change From Baseline in Clinical Chemistry Parameters Alkaline Phosphatase, Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase for Part 1|Blood samples were collected for the assessment of chemistry parameters namely alkaline phosphatase, ALT, AST, creatine kinase, GGT and lactate dehydrogenase for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 72 hours in Part 1|Safety Population|||International units/liter||Standard Deviation|Mean
2537383|NCT03136380|Primary|Change From Baseline in Clinical Laboratory Parameters Calcium, Cholesterol, Chloride, Glucose, High Density Lipids (HDL) Cholesterol, Potassium, Low Density Lipids (LDL) Cholesterol,Sodium,Phosphorus,Triglycerides,Urea/Blood Urea Nitrogen (BUN) in Part 1|Blood samples were collected for the assessment of chemistry parameters namely calcium, cholesterol, chloride, glucose, HDL cholesterol, potassium, LDL cholesterol, sodium, phosphorus, triglycerides, and urea/BUN results for Part 1. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 72 hours in Part 1|Safety Population|||Millimoles/liter||Standard Deviation|Mean
2537384|NCT03136380|Primary|Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 2|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant|Up to 21 days in Part 2|Safety Population|||Participants|||Number
2537385|NCT03136380|Primary|Number of Participants With Any Adverse Event (AE) and Serious Adverse Events in Part 1|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Safety population comprised of all participants who took at least one dose of study treatment.|Up to 32 days in Part 1|Safety Population|||Participants|||Number
2537386|NCT03136328|Secondary|Specificity to Detect True Negative|A tumor is an abnormal growth of cells which can be malignant or not. NET tumors secrete hormones that will disrupt the normal ecology of the body. 68Ga-DOTATOC is extremely sensitive and specific to the receptors expressed by NET. These attributes are unique to 68Ga-DOTATOC and makes it the only imagining technique that can determine whether or not lesions detected by conventional imaging is due to NET involvement. 68Ga-DOTATOC is able to exclude disease involvement in lesions detected on CT/MRI; this ability to exclude disease involvement is called Specificity. The reported values indicate the specificity of 68Ga-DOTATOC, which is the percentage of tumors detected by conventional imagining that 68Ga-DOTATOC correctly determined were not due to NET involvement (i.e. identifying true negative for NET).|During imaging process ( approximately 120 minutes)||||percent of tumors identified as non-NET|||Number
2537387|NCT03136328|Primary|Sensitivity to Correctly Diagnose NET|Sensitivity to detect NET will be assessed and compared with conventional imaging modality. Sensitivity is the ability of an agent to indicate the presence and location of NET. The ability of 68Ga-DOTATOC to localize more effectively to somatostatin receptors and the exquisite spatial resolution of PET/CT should make easier detection of primary and metastatic neuroendocrine tumors and allow better measurement of tumor burden. Sensitivity is the percentage of accurately diagnosed NET cases. All participants underwent conventional imaging with either Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) as standard care prior to 68Ga-DOTATOC imaging.|During imaging process ( approximately 120 minutes)||||percent of NET correctly diagnosed|||Number
2537388|NCT03136107|Primary|Arithmetic Mean of Individual Sun Protection Factor (SPFi) Value|Arithmetical mean of all valid SPFi values of each product on each participant was calculated from the individual Minimal Erythemal Dose (MED) on product treated (MEDp) test sites in relation to unprotected (MEDu) test sites 16-24 hours after exposure to ultraviolet (UV) radiation (SPFi = MEDp/MEDu). The Minimal Erythemal Dose (MED) was defined as the lowest dose of UV radiation that produced the first perceptible unambiguous erythema with defined borders appearing over most of the field of UV exposure, 16 to 24 hours after UV exposure. No inferential statistical analysis has been performed for this outcome. Test and reference products achieved a 95% CI of ±16.4% and ±16.6% of the mean SPF. These data meet the statistical criterion defined in ISO 24444:2010 as the 95% CI is within ±17% of the mean SPF.|Up to 24 hours post UV exposure|Intent to treat (ITT, N= 25) all valid participants data with no major protocol deviations were included in the SPF calculations. All participants exposed to Ultra Violet (UV) radiation were included the safety population, irrelevant of whether they successfully complete the study.|||Ratio (unit less)||95% Confidence Interval|Mean
2545587|NCT02940327|Primary|CD14/41|Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.|48 hours after ECMO commencement||||percentage change||Standard Deviation|Mean
2537394|NCT03135899|Secondary|Time to Recovery of FEV1 to Within 95% of Post-diluent Value in Part 2|Time to recovery of FEV1 to within 95% of post-diluent value in Part 2 was defined as the time from maximum reduction to last time before recovery to within 95% of the value obtained pre-methacholine challenge during the respective challenge. Median is actually model-based median.|Day 2|MCS|||h||95% Confidence Interval|Median
2537395|NCT03135899|Secondary|Time to Recovery of FEV1 to Within 95% of Post-diluent Value in Part 1|Time to recovery of FEV1 to within 95% of post-diluent value in Part 1 was defined as the time from maximum reduction to last time before recovery to within 95% of the value obtained pre-methacholine challenge during the respective challenge.|Day 2|MCS|||hours (h)||Inter-Quartile Range|Median
2537396|NCT03135899|Secondary|Relative Change From Baseline in FEV1 Area Under the Curve Over the Time Interval From 0 to Timepoint tz (FEV1 AUC0-tz) Following Bolus Methacholine Challenge in Part 2|Relative change from baseline in FEV1 area under the curve over the time interval from 0 to timepoint tz (FEV1 AUC0-tz) following bolus methacholine challenge in Part 2 was defined as the ratio of FEV1 AUC0-tz obtained during the treatment challenge and during the baseline challenge, where the time tz refers to the last time point before recovery of FEV1 to within 95% of post-diluent value. Geometric mean is actually adjusted geometric mean. Standard error presented here is a geometric standard error.|Baseline and Day 2|MCS|||Ratio||Standard Error|Geometric Mean
2537397|NCT03135899|Secondary|Relative Change From Baseline in FEV1 Area Under the Curve Over the Time Interval From 0 to Timepoint tz (FEV1 AUC0-tz) Following Bolus Methacholine Challenge in Part 1|Relative change from baseline in FEV1 area under the curve over the time interval from 0 to timepoint tz (FEV1 AUC0-tz) following bolus methacholine challenge in Part 1 was defined as the ratio of FEV1 AUC0-tz obtained during the treatment challenge and during the baseline challenge, where the time tz refers to the last time point before recovery of FEV1 to within 95% of post-diluent value.|Baseline and Day 2|MCS|||Ratio||Standard Deviation|Mean
2537398|NCT03135899|Primary|Absolute Change From Baseline in Maximum Forced Expiratory Volume Within 1 Second (FEV1) Reduction Following Bolus Methacholine Challenge in Part 2.|Absolute change from baseline in maximum FEV1 reduction following bolus methacholine challenge in Part 2 was defined as the difference between the maximum reduction in FEV1 obtained during the treatment challenge and during the baseline challenge.|Baseline and Day 2|MCS|||Litres (L)||Standard Error|Least Squares Mean
2537399|NCT03135899|Primary|Absolute Change From Baseline in Maximum Forced Expiratory Volume Within 1 Second (FEV1) Reduction Following Bolus Methacholine Challenge in Part 1|Absolute change from baseline in maximum forced expiratory volume within 1 second (FEV1) reduction following bolus methacholine challenge in Part 1 was defined as the difference between the maximum reduction in FEV1 obtained during the treatment challenge and during the baseline challenge.|Baseline and Day 2|Methacholine set (MCS): The MCS included all patients in the TS who provided at least one pair (baseline and end-of-treatment) of evaluable measures of spirometry parameters that were not excluded due to use of rescue medication within 3 hours (h) after start of bolus methacholine challenge.|||Litres (L)||Standard Deviation|Mean
2537400|NCT03135548|Secondary|Percentage of Participants Achieving Treatment Success (Treatment Success Defined as Achieving a Clinical Response of 0 or 1=Clear/Almost Clear) Via Palmoplantar Pustulosis Physicians Global Assessment (pppPGA) at Week 16|"pppPGA was relied on the participant's overall skin lesions status on the lesions of the most severely affected palmoplantar surface of the palms and sole was assessed by investigator as clear (0), almost clear (1), mild (2), moderate (3) and severe (4) at week 16.~Score Wording were:~0 = Clear = No signs of PPP; no scaling or crusts or pustule remains.~= Almost clear = Slight scaling and/or erythema and / or slight crusts; very few new (yellow) and / or old (brown) pustules.~= Mild = Scaling and/or erythema and/or crusts; visible new (yellow) and/or old (brown) pustules of limited number and extent.~=Moderate = Prominent scaling and/or erythema and / or crusting; prominent new (yellow) and / or old (brown) pustules covering most of the area involved.~=Severe = Severe scaling and/or erythema and / or crusting; numerous new (yellow) or old (brown) pustules with and/or without major conflence covering the entire area of at least 2 palmoplantar surfaces."|Week 16|FAS (NRI)|||Percentage of participants (%)|||Number
2537401|NCT03135548|Secondary|Percent Change From Baseline in the ppPASI at Week 16|"The percentage change in the ppPASI score from Baseline to Week 16 was measured.~ppPASI is modification of PASI score and an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides a numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema (E), Pustules (P) (total), and scaling (Desquamation (D)). Missing values for severity or area of involvement were not imputed.~ppPASI was calculated as a weighted sum of the scores obtained for E, P, D and Area affected (in%) (where area assessed is glabrous skin on the palms/ soles) (A): [(E+P+D) x A x 0.2 (right palm)] + [(E+P+D) x A x 0.2 (left palm)] + [(E+P+D) x A x 0.3 (right sole)] + [(E+P+D) x A x 0.3 (left sole)]."|Baseline and Week 16|Patients from FAS with observed cases (OC) were included for analysis of this endpoint. (FAS (OC))|||Unit on scale||Standard Deviation|Mean
2537402|NCT03135548|Secondary|Percentage of Participants With Palmoplantar Pustular Psoriasis Area and Severity Index 75 (ppPASI75) at Week 16|"Percentage of participants who achieved >75% reduction in ppPASI score was assessed by ppPASI75.~ppPASI is modification of PASI score and an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides a numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema (E), Pustules (P) (total), and scaling (Desquamation (D)). Missing values for severity or area of involvement were not imputed.~ppPASI was calculated as a weighted sum of the scores obtained for E, P, D and Area affected (in%) (where area assessed is glabrous skin on the palms/ soles) (A): [(E+P+D) x A x 0.2 (right palm)] + [(E+P+D) x A x 0.2 (left palm)] + [(E+P+D) x A x 0.3 (right sole)] + [(E+P+D) x A x 0.3 (left sole)]."|Week 16|FAS (NRI)|||Percentage of participnats (%)|||Number
2537403|NCT03135548|Primary|Number of Participants With Drug-related Adverse Events (AEs)|Number of participants with drug-related AEs are presented.|From first drug administration until 16 weeks after the last drug administration, up to 32 weeks.|Safety analysis set (SAF): This set included all randomised patients who received at least one dose of study drug.|||Participants|||Number
2537404|NCT03135548|Primary|Percentage of Participants With Palmoplantar (pp) Pustular Psoriasis Area and Severity Index 50 (PASI) (ppPASI50) at Week 16|"Percentage of participants who achieved 50% reduction in ppPASI score was assessed by ppPASI50.~ppPASI is modification of PASI score and an investigator assessment of the extent and severity of pustular and plaque lesions on the palms and soles presenting in PPP participants. This tool provides a numeric scoring for participants overall PPP disease state, ranging from 0 to maximum 72, where 0 corresponds to no signs of psoriasis. It is a linear combination of the percent of surface area of skin that is affected on the palms and soles and the severity of Erythema (E), Pustules (P) (total), and scaling (Desquamation (D)). Missing values for severity or area of involvement were not imputed.~ppPASI was calculated as a weighted sum of the scores obtained for E, P, D and Area affected (in%) (where area assessed is glabrous skin on the palms/ soles) (A): [(E+P+D) x A x 0.2 (right palm)] + [(E+P+D) x A x 0.2 (left palm)] + [(E+P+D) x A x 0.3 (right sole)] + [(E+P+D) x A x 0.3 (left sole)]."|Week 16|Full analysis set (FAS): FAS included all patients in the Safety analysis set (SAF) (SAF included all randomised patients who received at least one dose of study drug) who had a baseline measurement available for the primary endpoint. Patients from FAS with no response imputation (NRI) were included for analysis of this endpoint. (FAS (NRI))|||Percentage of participants (%)|||Number
2537405|NCT03135535|Secondary|Change in Stride Velocity From Baseline to 4-week|The change in stride velocity was quantified by gait speed measured using a validated wearable sensor (LEGSys, Biosensics, LLC). The unit of measurement is meter per second (m/s)|Baseline to 4 weeks||||m/s||Standard Deviation|Mean
2537406|NCT03135535|Secondary|Change in Plantar Sensation From Baseline to 4-week|The change in plantar sensation after 4-weeks use of AVEX Footbeat will be assessed using vibratory perception threshold (VPT) test. The unit of this measurement is volt.|Baseline to 4 weeks||||volts||Standard Deviation|Mean
2537407|NCT03135535|Secondary|Change in Lower Extremity Edema From Baseline to 4 Weeks|Edema will be measured by traditional circumference change of ankle. The unit of measurement is cm.|Baseline and 4 weeks||||cm||Standard Deviation|Mean
2537408|NCT03135535|Primary|Change in Skin Perfusion From Baseline to 4 Weeks|Skin perfusion was quantified using Skin Perfusion Pressure Test (SPP) at the lower extremities at baseline and at 4-week (end point). The measurement of SPP was done using a device called Sensilase PAD-IQ (VASAMED). The unit of measurement is mmHg.|Baseline and 4 weeks||||mmHg||Standard Deviation|Mean
2537409|NCT03135535|Primary|Change in Balance From Baseline to 4 Weeks|Balance will be quantified by measuring body sway in medial-lateral direction using a validated wearable sensors technology (Balansens, Biosensics LLC) and body sway change after 4-weeks of daily use of AVEX Footbeat will be assessed compare to baseline. Th unit of measurement is cm.|baseline and 4 weeks.||||cm||Standard Deviation|Mean
2537410|NCT03135431|Secondary|Estimated Blood Loss|Identify mean difference in estimated total blood loss as a result of standard bilateral tubal ligation surgical procedure and bilateral salpingectomy procedure, following cesarean delivery.|Day of surgery||||mL||Standard Deviation|Mean
2537411|NCT03135431|Secondary|Operative Time|Compare mean difference in length of operative time (in minutes) to perform bilateral salpingectomy as compared to standard bilateral tubal ligation, following cesarean delivery.|Day of surgery||||mins||Standard Deviation|Mean
2537412|NCT03135431|Primary|Mean Difference Between Pre and Postoperative Hemoglobin (g/dl)|Identify the mean difference in pre and postoperative hemoglobin for patients undergoing salpingectomy for sterilization vs. patients undergoing standard bilateral tubal ligation via mid-segment resection of the fallopian tube at the time of cesarean delivery.|At least 24 but not greater than 48 hours after surgery|One patient in the Salpingectomy group is was missing post operation hemoglobin|||g/dL||Standard Deviation|Mean
2537413|NCT03135379|Secondary|Ultrasound Image Quality|Measured 1 (low) to 5 (high) by an attending emergency physician who has completed ultrasound fellowship.|Within 1 week of completion of ultrasound examination||||units on a scale||Inter-Quartile Range|Median
2537414|NCT03135379|Primary|Patient Satisfaction|"Measured on 100-mm visual analogue scale. This scale is a horizontal line on a sheet of paper measuring 100 mm. The scale ranges from 0 on the left (representing completely unsatisfied) to 100 on the right (representing completely satisfied). We instructed subjects to draw a single vertical mark through the horizontal line to represent how satisfied they were with their overall emergency department visit."|Immediately upon completion of ultrasound examination||||units on a scale||95% Confidence Interval|Mean
2537415|NCT03135028|Secondary|Plasma Concentration of ENTO|Plasma concentration of drug (ENTO) over different time points is reported.|Cycle 1 (28-days cycle) Day 8 at 0 (predose), 1, 2, 3, 4, 6, 8, and 12 hours postdose|Pharmacokinetic (PK) Analysis Set included all participants in the Full Analysis Set who had necessary baseline and at least 1 non-missing post-treatment assessments. Participants with available data were analyzed. PK parameters were not derived from the collected data due to the early study termination.|||ng/mL||Standard Deviation|Mean
2537416|NCT03135028|Secondary|Percentage of Participants With AEs and Laboratory Abnormalities Not Defined as DLT||Day 1 Up to 30 days after permanent discontinuation of study treatment (maximum approximately 80 weeks)|Full Analysis Set included all participants who received at least 1 dose of study drug (ENTO).|||percentage of participants|||Number
2537417|NCT03135028|Primary|Percentage of Participants With Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT)|"Occurrence of any of the following toxicities, attributable to ENTO, during Cycle 1 was considered DLT:~Grade 4 non-hematologic toxicity except alopecia, nausea, and vomiting controllable with anti-emetic therapy, line associated venous thrombosis, infection-related toxicities such as fever/sepsis, and fatigue.~In participants without bone marrow evidence of hematologic malignancy, hematologic toxicity defined as failure to recover absolute neutrophil count (ANC > 500/μL) or platelet count (>25000/μL) within 28 days~Grade 4, clinically significant, electrolyte abnormalities that were not correctable within 24 hours~Liver function test abnormalities that did not resolve to Grade 2 within 10 days~Infection that resulted from unexpectedly complicated prolonged myelosuppression~Toxicities that required temporary interruption of treatment and did not resolve to Grade 2 within 10 days or ENTO was suspended or dose reduced for a period of more than 10 days."|Cycle 1 (28-day cycle)|The DLT Analysis Set included all participants in the Full Analysis Set (all participants who received at least 1 dose of study drug [ENTO]) who received at least 21 days of ENTO or experienced a DLT during DLT assessment window.|||percentage of participants|||Number
2537418|NCT03135015|Post-Hoc|Insulin Change From Baseline at 90 Minutes in All Participants|Change from baseline (CFB) in insulin will be computed at 90 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.|From Baseline at 90 minutes|The analysis of other outcome measures is based on all randomized subjects who received this intervention and for whom the outcome data is known. There is no missing value imputation.|||uU/mL||Standard Error|Mean
2537419|NCT03135015|Post-Hoc|Blood Glucose Change From Baseline at 90 and 120 Minutes in Overweight Participants|Change from baseline (CFB) in blood glucose will be computed at 90 and 120 minutes for the Obese/Overweight Participants. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.|From Baseline at 90 and 120 minutes|Arms/Groups are provided as appropriate. The analysis of other outcome measures is based on all randomized subjects who received this intervention and for whom the outcome data is known. There is no missing value imputation.|||mmol/L||Standard Error|Mean
2537420|NCT03135015|Post-Hoc|Blood Glucose Change From Baseline at 90 and 120 Minutes in Lean Participants|Change from baseline (CFB) in blood glucose will be computed at 90 and 120 minutes for the Lean Participants. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.|From Baseline at 90 and 120 minutes|Arms/Groups are provided as appropriate. The analysis of other outcome measures is based on all randomized subjects who received this intervention and for whom the outcome data is known. There is no missing value imputation.|||mmol/L||Standard Error|Mean
2537421|NCT03135015|Post-Hoc|Blood Glucose Change From Baseline at 90 and 120 Minutes in All Participants|Change from baseline (CFB) in blood glucose will be computed at 90 and 120 minutes. The CFB results for the capsule treatments and the water control will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.|From Baseline at 90 and 120 minutes|The analysis of other outcome measures is based on all randomized subjects who received this intervention and for whom the outcome data is known. There is no missing value imputation.|||mmol/L||Standard Error|Mean
2537422|NCT03135015|Post-Hoc|60-Minute Blood Glucose Area Under the Curve (AUC)|Incremental area under the blood glucose response curve (AUC) will be computed using the values recorded at 60 minutes and beyond. The blinded AUC results for the Axulin capsule treatments and the water control will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment*group interaction. After demonstration of significant heterogeneity among the 3 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons.|1-2 hours post-dose|The analysis of other outcome measures is based on all randomized subjects who received this intervention and for whom the outcome data is known. There is no missing value imputation.|||mmol x min/L||Standard Error|Mean
2537423|NCT03135015|Post-Hoc|Blood Glucose Change From Baseline in the Water Control Compared to the Placebo Capsules at 90 Minutes for All Participants|Change from baseline (CFB) in blood glucose will be computed at 90 minutes. The CFB results for the water control and the placebo capsule treatments will be subjected to a paired t-test examining whether the mean difference between the two sets of observations is equal to zero.|From Baseline at 90 minutes|The analysis of the outcome measure is based on all randomized participants who received this intervention and for whom the outcome data is known. The comparison is between the water control and the placebo capsules only. There is no missing value imputation.|||mmol/L||Standard Error|Mean
2537424|NCT03135015|Other Pre-specified|Effect of Capsules vs. Tablets|Percentage change in blood glucose area under the curve (AUC) elicited by capsules compared to the same dose of tablets.|0, 15, 30, 45, 60, 90, and 120 minutes post-dose|The analysis of the outcome measure is based on all randomized participants who received this intervention and for whom the outcome data is known. There is no missing value imputation.|||mmol x min/L||Standard Error|Mean
2537425|NCT03135015|Other Pre-specified|Effect of Axulin in Lean vs. Overweight Participants|Percentage change in blood glucose area under the curve (AUC) in lean participants compared to overweight participants.|0, 15, 30, 45, 60, 90, and 120 minutes post-dose|Arms/Groups are provided as appropriate. The analysis of other outcome measures is based on all randomized subjects who received this intervention and for whom the outcome data is known. There is no missing value imputation.|||mmol x min/L||Standard Error|Mean
2537426|NCT03135015|Secondary|ISSI-2 Index of Beta-cell Function|Insulin Secretion-Sensitivity Index-2 (ISSI-2) is an index of β-cell function with insulin secretion adjusted for whole body insulin sensitivity. It is calculated by the total area under the curve for serum insulin divided by the area under the curve for blood glucose, and that result times the Matsuda insulin sensitivity index (defined above).|0, 30, 60, 90, and 120 minutes post-dose|The analysis of secondary outcome data is based on all randomized subjects who received this intervention and for whom secondary outcome data is known. There is no missing value imputation.|||Insulin Secretion-Sensitivity Index-2||Standard Error|Mean
2537427|NCT03135015|Secondary|Matsuda Insulin Sensitivity Index|Matsuda Insulin Sensitivity Index is an index of whole body insulin sensitivity derived from glucose and insulin responses after a 75g Oral Glucose Tolerance Test (OGTT). It is calculated by 10000 divided by the square root of (FG*FI*MG*MI) where FG is fasting glucose, FI is fasting insulin, MG is the mean AUC for blood glucose at 0, 30, 60, 90 and 120 minutes and MI is the mean AUC for serum insulin at 0, 30, 60, 90 and 120 minutes.|0, 30, 60, 90, and 120 minutes post-dose|The analysis of secondary outcome data is based on all randomized subjects who received this intervention and for whom secondary outcome data is known. There is no missing value imputation.|||Matsuda Insulin Sensitivity Index||Standard Error|Mean
2537428|NCT03135015|Secondary|Insulinogenic Index|Insulinogenic Index is an index of the ability of a change in blood glucose to stimulate an increase in serum insulin. It is a unitless measure with higher numbers indicating improved beta cell function. It is calculated by dividing the change in serum insulin between 0 and 30 minutes by the change in blood glucose between 0 and 30 minutes.|Baseline and 30 minutes|The analysis of secondary outcome data is based on all randomized subjects who received this intervention and for whom secondary outcome data is known. There is no missing value imputation.|||Insulinogenic Index||Standard Error|Mean
2545588|NCT02940327|Primary|CD14/41|Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.|24 hours after ECMO commencement||||percentage change||Standard Deviation|Mean
2537429|NCT03135015|Secondary|Percentage Change in Area Under The Curve (AUC) for Serum Insulin 0-2 Hours|Percentage change in the incremental area under the insulin response curve (AUC) after 75g glucose for the capsules containing Axulin powder relative to the water control. Incremental AUC is the AUC below the curve above the fasting level; area below fasting is ignored. Percentage change will be calculated as 100 x (A-P)/P where A and P are the mean AUC's after Axulin and water control treatments, respectively. The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons. The code will be broken after this analysis has been done. The percentage changes will be considered to be significant if the difference in mean AUC is significant.|0, 15, 30, 45, 60, 90, and 120 minutes post-dose|The analysis of secondary outcome data is based on all randomized subjects who received this intervention and for whom secondary outcome data is known. There is no missing value imputation.|||uU x min/ml||Standard Error|Least Squares Mean
2537430|NCT03135015|Secondary|Serum Insulin Area Under The Curve (AUC) 0-2 Hours|Incremental area under the serum insulin response curve (AUC) is the AUC below the insulin response curve above the fasting level; area below fasting is ignored. The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons. The code will be broken after this analysis has been done.|0, 15, 30, 45, 60, 90, and 120 minutes post-dose|The analysis of secondary outcome data is based on all randomized subjects who received this intervention and for whom secondary outcome data is known. There is no missing value imputation.|||uU x min/ml||Standard Error|Least Squares Mean
2537431|NCT03135015|Secondary|Blood Glucose Area Under The Curve (AUC) 0-2 Hours|Incremental area under the blood glucose response curve (AUC) is the AUC below the glucose response curve above the fasting level; area below fasting is ignored. The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons. The code will be broken after this analysis has been done.|0, 15, 30, 45, 60, 90, and 120 minutes post-dose|The analysis of secondary outcome data is based on all randomized subjects who received this intervention and for whom secondary outcome data is known. There is no missing value imputation.|||mmol x min/L||Standard Error|Least Squares Mean
2537432|NCT03135015|Primary|Percentage Change in Area Under The Curve (AUC) for Blood Glucose 0-2 Hours|Percentage change in the incremental area under the glucose response curve (AUC) after 75g glucose for capsules and tablets containing Axulin powder relative to the water control. Incremental AUC is the AUC below the curve above the fasting level; area below fasting is ignored. Percentage change will be calculated as 100 x (A-P)/P where A and P are the mean AUC's after Axulin and water control treatments, respectively. The blinded AUC results for the 6 treatments will be subjected to repeated measures analysis of variance (ANOVA) examining for the main effects of treatment and participant-group, and treatment*group interaction. After demonstration of significant heterogeneity among the 6 coded treatments, differences between individual means will be assessed using Tukey's test to adjust for multiple comparisons. The code will be broken after this analysis has been done. The percentage changes will be considered to be significant if the difference in mean AUC is significant.|0, 15, 30, 45, 60, 90, and 120 minutes post-dose|The analysis of primary outcome data is based on all randomized subjects who received this intervention and for whom primary outcome data is known. There is no missing value imputation.|||mmol x min/L||Standard Error|Least Squares Mean
2537433|NCT03134911|Secondary|The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Treatment|The percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with concomitant treatment is presented.|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.|||Percentage of patients (%)|||Number
2537434|NCT03134911|Secondary|The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Active Concomitant Diseases on Visit Day|The percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with active concomitant diseases on visit day. The percentage was calculated on total patients who presented each of the diseases.|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.|||Percentage of patients (%)|||Number
2537435|NCT03134911|Secondary|The Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With Concomitant Diseases|The percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with at least one other concomitant diseases recorded in the medical history.|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.|||Percentage of patients (%)|||Number
2537436|NCT03134911|Secondary|Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients Received Type of VKA Treatment|Percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients received type VKA treatment is presented.|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.|||Percentage of patients (%)|||Number
2537461|NCT03134248|Primary|Lens Preference With Respect to Overall Comfort|Overall comfort preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference|1 week||||Participants|||Count of Participants
2537462|NCT03134248|Primary|Visual Quality|Subjective ratings of lens performance for visual quality assessed. Visual quality Scale 0-10, 0=completely dissatisfied, 10=completely satisfied|1 week||||units on a scale||Standard Deviation|Median
2537437|NCT03134911|Secondary|Time Since Treatment Initiation of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients|Time since treatment initiation of uncontrolled non-valvular atrial fibrillation (NVAF) patients was calculated as the time from the start date of treatment to the date of the baseline visit.|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.|||Months||Standard Deviation|Mean
2537438|NCT03134911|Secondary|Therapeutic Time in Range (TTR%) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients|Therapeutic time in range (TTR%) of uncontrolled non-valvular atrial fibrillation (NVAF) patients determined by the Rosendaal method (poor control < 65%) or by the direct method (poor control < 60%).|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.|||Percentage (%)||Standard Deviation|Mean
2537439|NCT03134911|Secondary|Number of Visits to the Physician of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients|Number of visits to the internal medicine specialist per year of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.|||Visits per year||Standard Deviation|Mean
2537440|NCT03134911|Secondary|Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Haemorrhagic Events by Categories|Percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with history of haemorrhagic events by categories are presented.|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.|||Percentage of patients (%)|||Number
2537441|NCT03134911|Secondary|Percentage of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients With History of Thromboembolic Events by Categories|Percentage of uncontrolled non-valvular atrial fibrillation (NVAF) patients with history of thromboembolic events by categories are presented.|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.|||Percentage of patients (%)|||Number
2537442|NCT03134911|Secondary|HAS-BLED Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients|HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio (INR), Elderly (>65 years), Drugs and Alcohol. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome.|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.|||Unit on scale||Standard Deviation|Mean
2537443|NCT03134911|Secondary|CHA2DS2-VASc Score of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients|CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.|||Unit on scale||Standard Deviation|Mean
2537444|NCT03134911|Secondary|Percentage of Patients With Left Ventricular Ejection Fraction (LVEF) Depression of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients|Percentage of patients with left ventricular ejection fraction (LVEF) depression (% of LVEF depression) of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented qualitatively.|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.|||Percentage of patients (%)|||Number
2537445|NCT03134911|Secondary|Left Ventricular Ejection Fraction (LVEF) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients|Left ventricular ejection fraction (LVEF) of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.|||Percentage (%)||Standard Deviation|Mean
2537446|NCT03134911|Secondary|History of Non-valvular Atrial Fibrillation (NVAF) - Age at Diagnosis|Age at diagnosis of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.|||Years||Standard Deviation|Mean
2537447|NCT03134911|Secondary|History of Non-valvular Atrial Fibrillation (NVAF) - Time Since Diagnosis|Analysis of data regarding the specific NVAF profile of uncontrolled patients indicated that the average (± SD) time since diagnosis (calculated as the time from the date of diagnosis to the date of the baseline visit).|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.|||Years||Standard Deviation|Mean
2537463|NCT03134248|Primary|Dryness|Subjective ratings of lens performance for dryness assessed. Dryness Scale 0-10, 0=extremely dry, 10=no dryness|1 week||||units on a scale||Standard Deviation|Median
2537464|NCT03134248|Primary|Comfort|Subjective ratings of lens performance for comfort assessed. Comfort Scale 0-10, 0=painful, 10=can't feel the lenses.|1 week||||units on a scale||Standard Deviation|Median
2537448|NCT03134911|Secondary|Kidney Function (Creatinine Clearance) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients|Kidney function of uncontrolled non-valvular atrial fibrillation (NVAF) patients measured by creatinine clearance is presented.|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. The number of patients included in the analysis of this variable has been specified.|||Millilitre/minute (ml/min)||Standard Deviation|Mean
2537449|NCT03134911|Secondary|Body Mass Index (BMI) of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients|BMI of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. The number of patients included in the analysis of this variable has been specified.|||Kilogram/meter^2 (kg/m^2)||Standard Deviation|Mean
2537450|NCT03134911|Secondary|Weight of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients|Weight of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. The number of patients included in the analysis of this variable has been specified.|||Kilogram (kg)||Standard Deviation|Mean
2537451|NCT03134911|Secondary|Height of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients|Height of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included. The number of patients included in the analysis of this variable has been specified.|||Centimeter (cm)||Standard Deviation|Mean
2537452|NCT03134911|Secondary|Demographic Data of Uncontrolled Non-valvular Atrial Fibrillation (NVAF) Patients|Age group, work status and life status of uncontrolled non-valvular atrial fibrillation (NVAF) patients is presented.|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) treatment at least 6 months and up to 2 years with uncontrolled anticoagulation status were included.|||Participants|||Number
2537453|NCT03134911|Primary|Health Related Quality of Life (QoL) (HRQoL) Scores in the Spanish Adaptation of the Sawicki Questionnaire|Sawicki questionnaire includes 32 items grouped in 5 dimensions: 1) general treatment satisfaction, 2) self-efficacy, 3) strained social network, 4) daily hassles and 5) distress. Patients estimated the impact of each item on their self-perceived treatment-related QoL on a scale of 1 (total disagreement) to 6 (total agreement). Response options for each question were: 1=not at all, 2=very little, 3=a little, 4=somewhat, 5=a lot, 6=very much. High scores in general treatment satisfaction and self-efficacy dimensions indicate high perceived HRQoL. Low scores in the strained social network, daily hassles and distress dimensions indicate high perceived HRQoL. The summary score for each dimension was calculated by dividing the total score of the sum of the items that comprise each dimension into the number of items included in that dimension. For the general treatment satisfaction dimension, the scores of individual questions have to be inverted first to calculate the dimension score.|The study consisted of a single visit between April 2017 and January 2018|All patients with non-valvular atrial fibrillation (NVAF), who received conventional vitamin K antagonist (VKA) with uncontrolled anticoagulation status and those with controlled anticoagulation status receiving VKA or direct oral anticoagulant (DOAC) treatment at least 6 months and up to 2 years were included.|||Unit on scale||Standard Deviation|Mean
2537454|NCT03134768|Primary|Allergen Stimulated Cytokine Expression in the Supernatants of Cord Blood Mononuclear Cells (CBMC)|Cellular response to allergen stimulation will be measured in supernatants of cultured cord blood mononuclear cells.|1 year|IL-6 was measured after incubation with House Dust mite extracts. The mean expression of IL-6 by the cord blood mononuclear cells in response to house dust mite extract is presented here.|||pg/ml||Standard Deviation|Mean
2537455|NCT03134768|Primary|Cord Blood Immunoglobulin Levels|Immunoglobulin levels will be measured in cord blood plasma|1 year||||pg/ml||Standard Deviation|Mean
2537456|NCT03134768|Primary|Cytokines Profile in Cord Blood Plasma|Following cytokines will be part of the profile: IL-6, IL-1, IL-2, IL-4, IL-5, IL-7, IL-8, IL-10, IL12p70, IL-13, IL-17, G-CSF, GM-CSF, IFNg, MCP-1(MCAF), MIP-1b, TNFa|1 year|Other cytokines were out of detection limits.|||pg/ml||Standard Deviation|Mean
2537457|NCT03134599|Primary|Comfort|Subjective ratings of comfort for each lens pair was assessed. Scale 0-100, 0=causes pain, 100=very comfortable.|1 week per intervention||||units on a scale||Standard Deviation|Mean
2537458|NCT03134326|Primary|Sub-Range Performance Equivalence of R2-25 and R1-25 Sensors by ARMS Calculation|Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours||||g/dL|||Number
2537459|NCT03134313|Primary|Accuracy of SpHb on R1-25 by Arms Calculation|Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours per subject||||g/dL|||Number
2537460|NCT03134248|Primary|Lens Preference With Respect to Visual Quality|Overall visual quality preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference|1 week||||Participants|||Count of Participants
2537465|NCT03134222|Secondary|Percentage of Participants at Week 24 With No Worsening in CLASI Activity Score From Baseline|CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.|Baseline; Week 24|||||||
2537466|NCT03134222|Secondary|Percentage of Participants at Week 24 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline|CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.|Baseline; Week 24|||||||
2537467|NCT03134222|Secondary|Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline|CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease. Worsening was defined as ≥ 3 point increase in CLASI activity score.|Baseline; Week 12|Participants in the Full Analysis Set were analyzed. Missing data are imputed as No Response.|||Percentage of participants||95% Confidence Interval|Number
2537468|NCT03134222|Secondary|Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline|CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.|Baseline; Week 12|Participants in the Full Analysis Set were analyzed. Missing data are imputed as No Response.|||Percentage of participants||95% Confidence Interval|Number
2537469|NCT03134222|Primary|Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12|CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.|Baseline; Week 12|Participants in the Full Analysis Set (who were randomized and received at least one dose of study drug (filgotinib, lanraplenib or placebo)) with available data were analyzed.|||score on a scale||Standard Error|Least Squares Mean
2537470|NCT03134183|Secondary|Cervical Dilation|Pratt Dilator initially accepted without resistance starting from 65 and working down|At end of procedure||||“French” circumference in millimeters||Standard Deviation|Mean
2537471|NCT03134183|Primary|Procedure Time|Time from initial uterine instrumentation to speculum out|At end of procedure||||minutes||Standard Deviation|Mean
2537472|NCT03133767|Secondary|Participants That Sought Care From Another Healthcare Provider for the Same Complaint|"Seven days after study enrollment, participants were asked by text message, Have you seen another medical provider for the same complaint?."|7 days|Response rates for the secondary outcomes were 47.4% (n=36) in the NS group and 53.3% (n=42) in the LR group.|||Participants|||Count of Participants
2537473|NCT03133767|Secondary|Number of Participants That Returned to the ED Within 7 Days for the Same Complaint|"Seven days after study enrollment, participants were asked by text message, Have you returned to the emergency department for the same problem?"|7 days|Response rates for the secondary outcomes were 47.4% (n=36) in the NS group and 53.3% (n=42) in the LR group.|||Participants|||Count of Participants
2537474|NCT03133767|Secondary|Number of Participants That Filled an ED Prescription|"Seven days after study enrollment, participants were asked by text message, Have you filled any prescriptions from the emergency department?"|7 days after study enrollment|Only participants that received an ED prescription and responded to the seven-day text message were included in this analysis (26 participants in the LR and 25 in the NS group).|||Participants|||Count of Participants
2537475|NCT03133767|Secondary|Quality of Recovery-40 Score After Administration|The Quality of Recovery-40 (QoR-40) is a validated instrument that quantifies patient's self-assessment of functional recovery, symptoms, and physical comfort. The QoR-40 scores range from 40 to 200 with a 200 representing a better recovery outcome. The survey consists of 40 questions scored from one to five with a Likert scale, and the total score is the sum of each question.|Immediately after fluid administration||||units on a scale||95% Confidence Interval|Mean
2537476|NCT03133767|Primary|Quality of Recovery-40 Score at 24 Hours|The Quality of Recovery-40 (QoR-40) is a validated instrument that quantifies patient's self-assessment of functional recovery, symptoms, and physical comfort. The QoR-40 scores range from 40 to 200 with a 200 representing a better recovery outcome. The survey consists of 40 questions scored from one to five with a Likert scale, and the total score is the sum of each question.|24 hours after ED visit||||units on a scale||95% Confidence Interval|Mean
2537477|NCT03133481|Secondary|Mean Opioid Consumption as Measured in Oral Morphine Equivalents|Mean opioid consumption as calculated from Anesthesia Record Stop Time to 48 hours after Anesthesia Record Stop Time in Oral Morphine Milligram Equivalents|From immediately post operatively through 48 hours||||Oral Morphine Milligram Equivalents||Standard Deviation|Mean
2537478|NCT03133481|Secondary|Mean Opioid Consumption as Measured in Oral Morphine Milligram Equivalents|Mean opioid consumption as calculated from the time of Anesthesia Record Stop Time to 24 hours after Anesthesia Record Stop Time in Oral Morphine Equivalents|From immediately post operatively through 24 hours||||Oral Morphine Milligram Equivalents||Standard Deviation|Mean
2537589|NCT03128723|Secondary|Cutaneous Tolerance Scores: Erythema|Cutaneous Tolerance Scores: Erythema (assessing skin redness), from Baseline to Day 14. Scale range is 0-3 where 0 = no redness, 1 = mild redness, 2 = moderate redness, and 3 = severe redness.|Baseline to Day 14||||Units on a scale||Standard Deviation|Mean
2537480|NCT03133481|Secondary|Mean Pain Scores 48 Hours Postoperatively|"Visual Analog Scale (VAS) score at 48 hours from the time of Anesthesia Record Stop Time.~The Visual Analog Scale is a standard numerical pain score reported by the patient, from 0-10, where 0=no pain, and 10=worst pain."|From the Anesthesia Record Stop Time to 48 hours from the Anesthesia Record Stop Time||||score on a scale||Standard Deviation|Mean
2537481|NCT03133481|Secondary|Mean Pain Scores at 24 Hours|"Visual Analog Scale (VAS) score at 24 hours from the time of Anesthesia Record Stop Time.~The Visual Analog Scale is a standard numerical pain score reported by the patient, from 0-10, where 0=no pain, and 10=worst pain."|From the Anesthesia Record stop time to 24 hours after Anesthesia Record stop time||||score on a scale||Standard Deviation|Mean
2537482|NCT03133481|Secondary|Mean Pain Scores in PACU|"The Mean Pain Score (VAS) at no more than 4 hours after the Anesthesia Record Stop Time.~The Visual Analog Scale is a standard numerical pain score reported by the patient, from 0-10, where 0=no pain, and 10=worst pain."|Immediately post operatively, not more than 4 hours after pacu admittance||||score on a scale||Standard Deviation|Mean
2537483|NCT03133481|Secondary|Mean Hours to Discharge|Mean hours to discharge, from the time of admittance to the time of discharge|Baseline to discharge (approximately 90 hrs)||||hours||Standard Deviation|Mean
2537484|NCT03133481|Secondary|Patient Satisfaction at 48 Hours Post Operatively|Patient satisfaction score, on an analog scale from 0-10, with 0 being the lowest satisfaction and 10 being the highest satisfaction.|Baseline up to 48 hrs||||score on a scale||Standard Deviation|Mean
2537485|NCT03133481|Secondary|Mean Opioid Consumption as Measured by Oral Morphine Milligram Equivalents|Preoperatively, opioid consumption will be measured from baseline to the Anesthesia Record Start Time in Oral Morphine Equivalents|from baseline to two hours||||Oral Morphine Milligram Equivalents||Standard Deviation|Mean
2537486|NCT03133481|Secondary|Mean Pain Scores Immediately Preoperatively|"Visual Analog Scale (VAS) score immediately preoperatively.~The Visual Analog Scale is a standard numerical pain score reported by the patient, from 0-10, where 0=no pain, and 10=worst pain."|baseline up to time of anesthesia record start time||||score on a scale||Standard Deviation|Mean
2537487|NCT03133481|Primary|Mean Distance Ambulated at 48 Hours Post Operatively|Distance ambulated in feet from the end of surgery to 48 hours postoperatively|From the Anesthesia Record Stop Time to 48 hours after the Anesthesia Record Stop Time||||feet||Standard Deviation|Mean
2537488|NCT03133481|Primary|Mean Distance Ambulated at 24 Hours Post Operatively|Distance ambulated in feet from the end of surgery to 24 hours postoperatively|Baseline up to 24 hours after the Anesthesia Record Stop Time||||feet||Standard Deviation|Mean
2537489|NCT03132571|Secondary|Waist Circumference (Inches)|Waist circumference will be measured in inches at each assessment.|Baseline and Week 16|Presented are the baseline and 16 weeks summary data on the 5 patients enrolled.|||inches||Standard Deviation|Mean
2537490|NCT03132571|Secondary|Health Risk Markers|Serum lipid profiles, fasting glucose, and glycosylated hemoglobin (hbA1c) will be measured at baseline and week 16 and change in these markers will be determined at endpoint|Baseline to Week 16|These labratory data were not collected and summarized due to the removal of diabetes from the study criteria and the early termination of the study.||||||
2537491|NCT03132571|Secondary|Weight (kg)|Weight in kilograms will be measured at each assessment and change will be determined at study endpoint.|Baseline and Week 16|Presented are the baseline and 16 weeks summary data on the 5 patients enrolled.|||kg||Standard Deviation|Mean
2537492|NCT03132571|Primary|BMI|BMI will be calculated using weekly height and weight measurements (kg/m^2) at each assessment.|Baseline and Week 16|Presented are the baseline and 16 weeks summary data on the 5 patients enrolled.|||kg/m^2||Standard Deviation|Mean
2537493|NCT03132298|Other Pre-specified|Implicit Personality Theory Questionnaire|"The Implicit Personality Theory Questionnaire asks participants to indicate on a 1 (really disagree) to 6 (really agree) scale the extent to which they endorse three statements: You have a certain personality, and it is something that you can't do much about; Your personality is something about you that you can't change very much; and Either you have a good personality or you don't, and there is really very little you can do about it. Numerical scores are summed to yield a single, total implicit theory of personality score (score range=0-18); higher scores indicate a stronger entity theory of personality, and lower scores indicate stronger incremental theories of personality."|Baseline, immediately post-intervention, and 3-, 6-, and 9-month follow-up||||score on a scale||Standard Deviation|Mean
2537494|NCT03132298|Other Pre-specified|Brief Family Assessment Measure|"The BFAM is a 14-item parent report questionnaire assessing perceptions of family functioning during the previous 2 weeks. This instrument was created to provide an operational definition and means of measuring the seven constructs in the Process Model of Family Functioning; it includes two items relating to each construct. Items such as We take the time to listen to each other and When things aren't going well it takes too long to work them out are scored on a 5-point scale. Items are summed to create a total score (range: 0-70), with higher scores indicating greater familial dysfunction."|Baseline and 3-, 6-, and 9-month (final) follow-up||||score on a scale||Standard Deviation|Mean
2537495|NCT03132298|Other Pre-specified|Beck Anxiety Inventory|Parental anxiety symptoms were measured at baseline at 3-, 6-, and 9-month follow-up assessments using the Beck Anxiety Inventory (BAI; Beck & Steer, 1993), a widely-used self-report measure of anxiety in adults for use in clinical, community, and research settings. Respondents report the extent to which they have been bothered by each of 21 symptoms over the preceding week. Each item has four possible answer choices: Not at All; Mildly; Moderately, and Severely. Because the BAI's 21 items (each rated 0 to 3, for a total possible scores ranging from 0 to 63 - higher scores indicate higher levels of anxiety) describe the emotional, physiological, and cognitive symptoms of anxiety but not depression, it can discriminate anxiety from depression in adults.|Baseline and 3-, 6-, and 9-month (final) follow-up||||score on a scale||Standard Deviation|Mean
2537496|NCT03132298|Other Pre-specified|Beck Depression Inventory|Parental depressive symptoms were measured at baseline at 3-, 6-, and 9-month follow-up assessments using the Beck Depression Inventory-II (BDI-II). The BDI is one of the most widely used and evaluated self- report measures of adult depressive symptoms. For each of its 21 items, respondents select among four alternative responses reflecting the increasing levels of symptom severity (0 = no symptom present to 3 = severe symptom present). The total score was used in this study, with a possible score range of 0 to 63 at each assessment point. Higher scores indicate higher levels of depressive symptoms.|Baseline and 3-, 6-, and 9-month (final) follow-up||||score on a scale||Standard Deviation|Mean
2537497|NCT03132298|Secondary|Heart Rate Variability (HRV) Recovery Slope|HRV was assessed; specifically, the time-based root-mean square successive difference of normal-to-normal (N-to-N) intervals (rMSSD). RMSSD equates to mean shifts in the time elapsed between consecutive heartbeats, in milliseconds. It reflects parasympathetically mediated, short-term changes in HRV. More rapid post-stressor increases in rMSSD (during the 5-min post stressor recovery period) indicated a more adaptive recovery trajectory following stress. Here, rMSSD was computed using the Acqknowledge automated time-series HRV analysis function.|Assessed at immediate post-intervention only||||msec||Standard Deviation|Mean
2537498|NCT03132298|Secondary|Electrodermal Activity (EDA) Recovery Slope|EDA was assessed continuously during the laboratory baseline (5 min prior to the social stress induction), social stress induction, and recovery period (5 min following the social stress induction) using Biopac MP150 hardware at a sampling rate of 1000 readings persecond and a 0.5e1 Hz bandpass filter. EDA was measured with a Biopac GSR100C amplifier and two EDA isotonic gel electrodes placed on the thenar and hypothenar eminences of the child's nondominant hand. EDA data were acquired and analyzed using AcqKnowledge 4.1 Software. Research assistants trained by the first author manually identified and removed artifacts. Averages (expressed in micro-Siemens) for EDA during the baseline, speech preparation, speech, and recovery periods were calculated for each participant. Slopes of EDA change during the recovery were calculated, expressed in microSiemens per second.|Assessed at immediate post-intervention only||||microsiemens/second||Standard Deviation|Mean
2537499|NCT03132298|Secondary|Secondary Control Scale for Children (SCSC)|"The SCSC is a 20-item scale measuring perceived ability to exert secondary control: to influence the personal psychological impact of objective conditions on oneself, by adjusting oneself to fit those conditions. Item content reflects response patterns associated with various kinds of secondary control, such as finding a silver lining (I can usually find something good to like, even in a bad situation.) and adjusting cognition (When something bad happens, I can find a way to think about it that makes me feel better.). Respondents rate agreement with each item on a 4-point Likert scale from very false to very true. Scores range from 0-60, with higher scores corresponding to higher (more adaptive) levels of perceived secondary control."|Baseline, immediately post-intervention, and 3-, 6-, and 9-month (final) follow-up||||score on a scale||Standard Error|Mean
2537500|NCT03132298|Secondary|Primary Control Scale for Children (PCSC)|"The PCSC is a 24-item scale measuring perceived ability to exert primary control: to influence or alter objective events or conditions through personal effort. Participants rated agreement with statements about their ability to exert primary control, with half the items worded in a positive direction (e.g., I can do well on tests if I study hard.) and half in a negative direction (e.g., I cannot get other kids to like me no matter how hard I try.). Responses range from very true to very false on a four-point Likert scale. Scores range from 0 to 72, with higher scores indicating higher (more adaptive) levels of perceived primary control."|Baseline, immediately post-intervention, and 3-, 6-, and 9-month (final) follow-up||||score on a scale||Standard Error|Mean
2537501|NCT03132298|Primary|Change in Screen for Child Anxiety Related Disorders - Parent (SCARED-P) From Baseline to 9-month Follow-up|Anxiety symptoms were assessed at baseline and at each follow-up point using the Screen for Child Anxiety and Related Disorders - Child and Parent versions (SCARED-C/SCARED-P). The SCARED-C and SCARED-P are child and parent versions of the same 41-item questionnaire measure of pediatric anxiety. Both differentiate between clinically anxious and nonanxious psychiatrically ill youth. Youths/parents respond to items using a 3-point Likert scale describing the degree to which statements are true about them; scores range from 0 to 82. Internal consistency, test-retest reliability, and construct validity of the SCARED are strong. In this study, the SCARED-C/P Total Scores were used and derived by summing all 41 items, with higher scores reflecting higher levels of anxiety.|Baseline and 3-, 6-, and 9-month (final) follow-up||||score on a scale||Standard Error|Mean
2537502|NCT03132298|Primary|Change in Screen for Child Anxiety Related Disorders - Child (SCARED-C) From Baseline to 9-month Follow-up|Anxiety symptoms were assessed at baseline and at each follow-up point using the Screen for Child Anxiety and Related Disorders - Child and Parent versions (SCARED-C/SCARED-P). The SCARED-C and SCARED-P are child and parent versions of the same 41-item questionnaire measure of pediatric anxiety. Both differentiate between clinically anxious and nonanxious psychiatrically ill youth. Youths/parents respond to items using a 3-point Likert scale describing the degree to which statements are true about them; scores range from 0 to 82. Internal consistency, test-retest reliability, and construct validity of the SCARED are strong (Hale, Raaijmakers, Muris, & Meeus, 2005; Myers & Winters, 2002). In this study, the SCARED-C/P Total Scores were used and derived by summing all 41 items, with higher scores reflecting higher levels of anxiety.|Baseline and 3-, 6-, and 9-month (final) follow-up||||score on a scale||Standard Error|Mean
2537503|NCT03132298|Primary|Change in Children's Depression Inventory - Parent (CDI-P) From Baseline to 9-month Follow-up|the Children's Depression Inventory, a 27-item self-report questionnaire that measures cognitive, affective, and behavioral symptoms of depression. Items are scored from 0-2, and scores range from 0 to 44; higher scores indicate greater symptom severity. The CDI and the parent analog (CDI-P) is reliable and valid. It can distinguish youths with more or less severe depressive symptoms, as well as youths at risk for depression from non-depressed youths. Suicide- and self-harm related questions were removed for the purposes of this study.|Baseline and 3-, 6-, and 9-month (final) follow-up||||scores on a scale||Standard Error|Mean
2537504|NCT03132298|Primary|Change in Children's Depression Inventory (CDI) From Baseline to 9-month Follow-up|the Children's Depression Inventory, a 27-item self-report questionnaire that measures cognitive, affective, and behavioral symptoms of depression. Items are scored from 0-2, and scores range from 0 to 44; higher scores indicate greater symptom severity. The CDI is reliable and valid. It can distinguish youths with more or less severe depressive symptoms, as well as youths at risk for depression from non-depressed youths. Suicide- and self-harm related questions were removed for the purposes of this study.|Baseline and 3-, 6-, and 9-month (final) follow-up||||scores on a scale||Standard Error|Mean
2537505|NCT03132220|Secondary|Change From Baseline in HADS-Depression Score|"Participants will also complete pre and post-intervention HADS surveys to assess changes in depression symptoms. This survey has 14 items that fall into either the anxiety domain (7 items) or the depression domain (7 items). Items are scored 0-3 and scores, with higher scores indicating worse outcomes, and 11+ in each domain indicating abnormal cases.~Scores for the 7 items in the depression domain are summed to yield a possible range of 0-21, with higher scores indicating more depression."|Once before the study intervention and once immediately after the intervention at 4 weeks||||score on a scale||Standard Deviation|Mean
2537506|NCT03132220|Secondary|Change From Baseline in PDS-5 Arousal Scores|"Participants will also complete pre/post-intervention PDS-5 surveys to assess post traumatic symptoms. This survey includes a pre-screen and 24 items. Each item is placed into the respective PTSD symptom category (as defined by the Diagnostic Statistical Manual-5) and scored. Higher scores in each symptom domain indicate increased chance of PTSD diagnosis. The domains are: intrusion (5 items), avoidance (2 items), changes in mood/cognition (7 items), and arousal/ hyperactivity (6 items). 2 items address distress and interference and 2 items address symptom onset and duration.~Scores for each question range from 0 to 3. The 6 items that contribute to the Arousal score are summed to yield a possible range of PDS Arousal scores of 0-18, with higher scores indicating greater arousal."|Once before the study intervention and once immediately after the intervention at 4 weeks||||score on a scale||Standard Deviation|Mean
2537507|NCT03132220|Secondary|Change From Baseline in PDS-5 Avoidance Score|"Participants will also complete pre/post-intervention PDS-5 surveys to assess post traumatic symptoms. This survey includes a pre-screen and 24 items. Each item is placed into the respective PTSD symptom category (as defined by the Diagnostic Statistical Manual-5) and scored. Higher scores in each symptom domain indicate increased chance of PTSD diagnosis. The domains are: intrusion (5 items), avoidance (2 items), changes in mood/cognition (7 items), and arousal/ hyperactivity (6 items). 2 items address distress and interference and 2 items address symptom onset and duration.~Scores for each question range from 0 to 3. The 2 items that contribute to the Avoidance score are summed to yield a possible range of PDS Avoidance scores of 0-6, with higher scores indicating greater avoidance."|Once before the study intervention and once immediately after the intervention at 4 weeks||||score on a scale||Standard Deviation|Mean
2537508|NCT03132220|Secondary|Change From Baseline in MBI- Personal Accomplishment Score|The Maslach Burnout Inventory (MBI) Personal Accomplishment subscale is a 8-item self-report questionnaire that measures feelings of personal accomplishment and success related to work. Scores can range between 0-48 with higher scores indicating greater sense of accomplishment.|Once before the study intervention and once immediately after the 4 session intervention||||score on a scale||Standard Deviation|Mean
2537509|NCT03132220|Secondary|Changes From Baseline in the MBI-Depersonalization Score|The Maslach Burnout Inventory (MBI) Depersonalization subscale is a 5-item self-report questionnaire that measures impersonal responses toward recipients of the respondent's efforts (e.g. patients). Scores can range between 0-30 with higher scores indicating greater depersonalization.|Once before the study intervention and once immediately after the intervention at 4 weeks||||score on a scale||Standard Deviation|Mean
2537510|NCT03132220|Secondary|Change From Baseline in HADS Anxiety Score|"Participants will also complete pre and post-intervention HADS surveys to assess changes in anxiety and depression symptoms. This survey has 14 items that fall into either the anxiety domain (7 items) or the depression domain (7 items). Items are scored 0-3 and scores, with higher scores indicating worse outcomes, and 11+ in each domain indicating abnormal cases.~Scores for the 7 items in the anxiety domain are summed to yield a possible range of 0-21, with higher scores indicating more anxiety."|Once before the study intervention and once immediately after the intervention at 4 weeks||||score on a scale||Standard Deviation|Mean
2537511|NCT03132220|Secondary|Change From Baseline in Post-traumatic Diagnostic Scale (PDS-5) - Intrusion Score|"Participants will complete pre/post-intervention PDS-5 surveys to assess post traumatic symptoms. This survey includes a pre-screen and 24 items. Each item is placed into the respective PTSD symptom category (as defined by the Diagnostic Statistical Manual-5) and scored. Higher scores in each symptom domain indicate increased chance of PTSD diagnosis. The domains are: intrusion (5 items), avoidance (2 items), changes in mood/cognition (7 items), and arousal/ hyperactivity (6 items). 2 items address distress and interference and 2 items address symptom onset and duration.~Scores for each question range from 0 to 3. The 5 items that contribute to the Intrusion score are summed to yield a possible range of PDS Intrusion scores of 0-15, with higher scores indicating greater intrusion."|Once before the study intervention and once immediately after the intervention at 4 weeks||||score on a scale||Standard Deviation|Mean
2537512|NCT03132220|Secondary|Qualitative Interviews|We will administer interviews to assess participant satisfaction with the intervention and control program. They will be administered to each group at the end of the intervention.|Once immediately after the study intervention at 4 weeks|Data were not collected||||||
2537513|NCT03132220|Secondary|Change From Baseline in Maslach Burnout Inventory (MBI) - Emotional Exhaustion Score|"Participants will also complete pre and post-intervention MBI surveys to assess changes in burnout symptoms. This survey is composed of 22 items. Each item is scored from 0-6. There are three questions domains: emotional exhaustion (9 items), depersonalization (5 items), and decreased person accomplishment (8 items). The items fall into one of these three categories and there are three domain scores. Higher values in each domain indicate increased burnout in that respective category.~Scores for each item in the Emotional Exhaustion subscale are summed to obtain an overall score. Overall scores for the Emotional Exhaustion subscale can range between 0-54."|Once before the study intervention and once immediately after intervention at 4 weeks.||||score on a scale||Standard Deviation|Mean
2537514|NCT03132220|Secondary|Changes in Acceptability of the Sessions, on the Client Satisfaction Questionnaire (CSQ-8)|This will be measured with the eight-item self-report Client Satisfaction Questionnaire (CSQ-8). This is survey has 8 items, and the total ranges from 1-32. Higher scores indicate higher satisfaction. The CSQ-8 will be administered before the intervention, weekly throughout the sessions and after the final treatment and control sessions.|Weekly during the 4 session/week intervention|Some pts. did not complete the CSQ-8 survey each week, thus variations in the no. of participants analyzed each week for the MBCT cohorts exist.|||score on a scale||Standard Deviation|Mean
2537515|NCT03132220|Primary|Change From Baseline in Connor Davidson Resiliency Scale (CD-RISC) Scores|The primary outcome is the pre-post changes in the CD-RISC scores in intervention and control subjects. The CD-RISC scale assesses resiliency in individuals. There are 25 items in the survey, each item is scored from 0-4, and the total ranges from 0-100. Higher scores indicate increased resiliency. Any individuals who score above 81 points on this survey will not qualify for this study as they are too inherently resilient. The study intervention will typically last 4 sessions, one session per week at a total of 4 weeks.|Once before the study intervention; one time immediately following the study intervention at 4 weeks.||||score on a scale||Standard Deviation|Mean
2537516|NCT03131999|Other Pre-specified|SGRQ|Saint Georges Respiratory Questionnaire change|2 months|||||||
2537517|NCT03131999|Other Pre-specified|Lung Function|FEV1 % predicted change|2 months|||||||
2537520|NCT03131895|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Dexlansoprazole||Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose|The PK set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration. PK analysis set where data at specified time points was available.|||ng*hour/mL||Standard Deviation|Mean
2537521|NCT03131895|Primary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Dexlansoprazole||Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose|The PK set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration.|||nanogram*hour per milliliter(ng*hour/mL)||Standard Deviation|Mean
2537522|NCT03131895|Primary|Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole||Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose|The pharmacokinetic (PK) set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2537523|NCT03131713|Secondary|Maximum Post-op Pain Score|Rated on a maximum post-op pain scale of 0-100. Higher score means worse outcome; lower score means better outcome.|48 hours after surgery||||score on a maximum post-op scale||Standard Deviation|Mean
2537524|NCT03131713|Secondary|Number of Participants Using Post-operative Analgesic|Number of participants using over the counter and prescribed non-opioid and opioid pain medications|48 hours after surgery||||Participants|||Count of Participants
2537525|NCT03131713|Secondary|Fatigue|Rated on a fatigue scale of 0-100. Higher score means worse outcome; lower score means better outcome.|Day of surgery||||score on a fatigue scale||Standard Deviation|Mean
2537526|NCT03131713|Secondary|Anxiety|Rated on n anxiety scale of 0-100. Higher score means worse outcome; lower score means better outcome.|Day of surgery||||score on an anxiety scale||Standard Deviation|Mean
2537527|NCT03131713|Secondary|Hunger|Rated on a hunger scale of 0-100. Higher score means worse outcome; lower score means better outcome.|Day of surgery||||units on a hunger scale||Standard Deviation|Mean
2537528|NCT03131713|Secondary|Thirst|Rated on a thirst scale of 0-100. Higher score means worse outcome; lower score means better outcome.|Day of surgery||||score on a thirst scale||Standard Deviation|Mean
2537529|NCT03131713|Primary|Maximum Pain Score|Rated on a pain scale of 0-100. Higher score means worse outcome; lower score means better outcome.|Day of surgery||||units on a pain scale||Standard Deviation|Mean
2537530|NCT03131687|Secondary|Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) of Tirzepatide|Pharmacokinetics (PK): Model Predicted Concentration at Steady State (Css) of Tirzepatide|Predose: Week 1,8,12 and 26; Postdose: Week 1,2,4 and 12|All randomized participants who received at least one dose of Tirzepatide study drug excluding post rescue data.|||Nanograms Per Millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2537531|NCT03131687|Secondary|Number of Participants With Anti-Drug Antibodies|Number of Participants With Anti-Drug Antibodies.|Baseline through Week 30|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2537532|NCT03131687|Secondary|Change From Baseline in Waist Circumference|LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment*Time.|Baseline, Week 26|All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value.|||centimeters (cm)||Standard Error|Least Squares Mean
2537533|NCT03131687|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)|LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment*Time.|Baseline, Week 26|All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value.|||Millimoles Per Litre (mmol/L)||Standard Error|Least Squares Mean
2537534|NCT03131687|Secondary|Change From Baseline in Triglycerides|LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment*Time.|Baseline, Week 26|All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value.|||Millimoles Per Litre (mmol/L)||Standard Error|Least Squares Mean
2537535|NCT03131687|Secondary|Change From Baseline in Total Cholesterol|LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag, Treatment, Time, Treatment*Time.|Baseline, Week 26|All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value.|||Millimoles Per Litre (mmol/L)||Standard Error|Least Squares Mean
2537536|NCT03131687|Secondary|Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)|LS means were calculated using MMRM model with independent variables: Baseline, Baseline HbA1C Group, Baseline BMI Group, Baseline Metformin Flag,Treatment, time, treatment*time.|Baseline, Week 26|All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value.|||Millimoles Per Litre (mmol/L)||Standard Error|Least Squares Mean
2537537|NCT03131687|Secondary|Change From Baseline in Fasting Blood Glucose|Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment*Time.|Baseline, Week 26|All randomized participants who received at least one dose of study drug who had a baseline and postbaseline value excluding data after study drug discontinuation or rescue drug initiation.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2537538|NCT03131687|Secondary|Percentage of Participants Reaching the HbA1c Target of <7.0%|Percentage of participants with HbA1c <7.0% at Week 26 using a logistic regression model for endpoint used last observation carried forward (LOCF) method including baseline value, baseline BMI Group, baseline Metformin and treatment as factors.|Week 26|All randomized participants who received at least one dose of study drug excluding data after study drug discontinuation or rescue drug initiation.|||percentage of participants|||Number
2537590|NCT03128723|Primary|Cutaneous Tolerance Scores: Tightness/Dry Feeling|Cutaneous Tolerance Scores: Tightness/Dry Feeling (assessing skin tightness/dry feeling), from Baseline to Day 28. Scale range is 0-3 where 0 = no tightness/dry feeling, 1 = mild tightness/dry feeling, 2 = moderate tightness/dry feeling, and 3 = severe tightness/dry feeling.|Baseline to Day 28||||Units on a scale||Standard Deviation|Mean
2537539|NCT03131687|Secondary|Percentage of Participants Reaching the HbA1c Target of ≤6.5%|Percentage of participants with HbA1c ≤6.5% at Week 26 using a logistic regression model for endpoint used last observation carried forward (LOCF) method including baseline value, baseline BMI Group, baseline Metformin and treatment as factors.|Week 26|All randomized participants who received at least one dose of study drug excluding data after study drug discontinuation or rescue drug initiation.|||percentage of participants|||Number
2537540|NCT03131687|Secondary|Percentage of Participants With 10% or Greater Body Weight Loss From Baseline|Percentage of participants with 10% or greater body weight loss from baseline LOCF analyses using Logistic regression model with Baseline value + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin + Treatment as factors.|Week 26|All randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
2537541|NCT03131687|Secondary|Percentage of Participants With 5% or Greater Body Weight Loss From Baseline|Percentage of participants with 5% or greater body weight loss from baseline last observation carried forward (LOCF) analyses using Logistic regression model with Baseline value + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin + Treatment as factors.|Week 26|All randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
2537542|NCT03131687|Secondary|Change From Baseline in Body Weight|Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1C Group + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment*Time.|Baseline, Week 26|All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value excluding data after study drug discontinuation or rescue drug initiation.|||Kilograms (Kg)||Standard Error|Least Squares Mean
2537543|NCT03131687|Secondary|Change From Baseline to Week 12 in HbA1c|HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: Baseline + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment*Time.|Baseline, Week 12|randomized participants who received at least one dose of study drug who had a baseline and postbaseline value excluding data after study drug discontinuation or rescue drug initiation.|||Percentage of HbA1c||Standard Error|Least Squares Mean
2537544|NCT03131687|Secondary|Change From Baseline to Week 26 in HbA1c|HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables: Baseline + Baseline BMI Group + Baseline Metformin Flag + Treatment + Time + Treatment*Time.|Baseline, Week 26|All randomized participants who received at least one dose of study drug who had a baseline and postbaseline value excluding data after study drug discontinuation or rescue drug initiation.|||Percentage of HbA1c||Standard Error|Least Squares Mean
2537545|NCT03131687|Secondary|Change From Baseline to Week 12 in Hemoglobin A1c (HbA1c) Bayesian Dose Response|"HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. This was a Bayesian dose response analysis of HbA1c (%) change from baseline. At baseline: Mean (SD = Standard Deviation) of baseline HbA1c (%). After baseline: Posterior Mean (SD = Posterior Standard Deviation) of HbA1c (%) change from baseline.~The Least Squares Mean is Posterior mean."|Baseline, Week 12|All randomized participants who received at least one dose of study drug and had a baseline and postbaseline value excluding data after rescue drug initiation.|||Percentage of HbA1c||Standard Deviation|Least Squares Mean
2537546|NCT03131687|Primary|Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c) Bayesian Dose Response|"HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.This was a Bayesian dose response analysis of HbA1c (%) change from baseline. At baseline: Mean (SD = Standard Deviation) of baseline HbA1c (%). After baseline: Posterior Mean (SD = Posterior Standard Deviation) of HbA1c (%) change from baseline.~The Least Squares Mean is Posterior mean."|Baseline, Week 26|All randomized participants who received at least one dose of study drug and had a baseline and postbaseline excluding data after rescue drug initiation.|||Percentage of HbA1c||Standard Deviation|Least Squares Mean
2537547|NCT03131596|Secondary|Pregnancy Outcome Within 12 Months Follow-up After Third Look Hysteroscopy|number of patients who have pregnancy, miscarriage and ectopic pregnancy within12 months follow-up|within 12 months after third look hysteroscopy(8 weeks post-operation)||||Participants|||Count of Participants
2537548|NCT03131596|Primary|Pictorial Blood Loss Assessment Chart Score 8 Weeks After Operation|"The Pictorial Blood Loss Assessment Chart (PBAC) score was used to represent the menstrual flow volume of the patient. The PBAC score was evaluated again at 8 weeks after surgery. A higher PBAC score after hysteroscopic adhesiolysis means a better outcome.The PBAC score of a normal women usually range from 30-100 points.~The minium value of PBAC score is 0, which means the patient is amenorrhea. The maximum value of PBAC score is 1000.~We measured the score before and 8 weeks after the operation in order to assess if there was any improvement (higher than before) in menstrual flow."|at 8 weeks post-operation||||score on a scale||Standard Deviation|Mean
2537549|NCT03131596|Primary|The American Fertility Society Score 8 Weeks After Operation|The American Fertility Society(AFS) score of each group was evaluated again at third-look hysteroscopy in order to reflect the efficacy of the treatment. The original AFS score was recorded in baseline characteristics part. The AFS score ranges from 0-12, while represented the severity of the adhesions. Mild 1-4, Moderate 5-8, Severe 9-12. The lower the AFS score is, the better the prognosis the patient is. When the surgery was finished the AFS score score should be 0.|at 8 weeks post-operation|The AFS score of each group was evaluated again after the whole procedure in order to reflect the efficacy of the treatment.|||score on a scale||Inter-Quartile Range|Median
2537550|NCT03131596|Primary|Number of Participants With Adhesion Reformation (American Fertility Society Score of Greater Than 0) 8 Weeks Later After the Index Surgery|The American Fertility Society (AFS) score ranges from 0-12, while represented the severity of the adhesions. Mild 1-4, Moderate 5-8, Severe 9-12. The lower the AFS score is, the better the prognosis the patient is. When the surgery was finished the AFS score should be 0. The reformation of intrauterine adhesions was evaluated by third-look hysteroscopy, if the score was greater than 0, a adhesion reformation was considered.|at 8 weeks post-operation|Intention-to-treat analysis was conducted on all outcomes.|||Participants|||Count of Participants
2545589|NCT02940327|Primary|CD14/41|Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.|12 hours after ECMO commencement||||percentage change||Standard Deviation|Mean
2537551|NCT03131479|Primary|Renal Clearance From Plasma (CLr) for LIK066|"Urine PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.~CLr was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done."|Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)|Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||Liter per hour (L/hr)||Standard Deviation|Mean
2537552|NCT03131479|Primary|Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) for LIK066 on Day 1|"Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.~Vz/F was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done."|Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)|Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.|||Liter (L)||Standard Deviation|Mean
2537553|NCT03131479|Primary|Apparent Systemic (or Total Body) Clearance From Plasma Following Extravascular Administration (CL/F) for LIK066 on Day 1|"Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.~CL/F was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Since Day 7 represented steady state of LIK066 in the study, the appropriately calculated steady-state clearance parameter computed was CLss/F and was presented. Only descriptive analysis done."|Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)|Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.|||Liter per hour (L/h)||Standard Deviation|Mean
2537554|NCT03131479|Primary|Terminal Elimination Half-life (T1/2) for LIK066 on Day 7|"Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.~T1/2 was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. T1/2 is only reported at Day 7 only, since there was sampling out to ~5 half-lives after the Day 7 dose of LIK066. Only descriptive analysis done."|Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)|Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.|||hour (hr)||Standard Deviation|Mean
2537555|NCT03131479|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) for LIK066 on Day 1|"Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.~AUCinf was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. AUCinf is a single dose parameter and therefore is presented on Day 1 only, after the first dose of LIK066. Only descriptive analysis done."|Day 1 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)|Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
2537556|NCT03131479|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for LIK066 on Day 7|"Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.~AUClast was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. AUClast is similar to AUCtau on Day 1 since the Tlast for Day 1 = 24hrs (tau = 24hrs); therefore AUClast is not reported for Day1, it is however reported for Day 7 since the Tlast is different from 24 hours. Only descriptive analysis done."|Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)|Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only descriptive analysis done.|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
2537569|NCT03131167|Primary|Number of Participants With Treatment Emergent Adverse Event (TEAE)|An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose.|From start of study drug administration up to follow-up (Day 88)|Safety set consisted of all participants who were randomized and who received at least 1 dose of investigational product.|||Participants|||Count of Participants
2537557|NCT03131479|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) for LIK066|"Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.~AUCtau was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done."|Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)|Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
2537558|NCT03131479|Primary|Time to Reach the Maximum Plasma Concentration (Tmax) for LIK066|"Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.~Tmax was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done."|Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)|Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||hour (hr)||Full Range|Median
2537559|NCT03131479|Primary|Maximum Observed Plasma Concentration (Cmax) for LIK066|"Plasma PK samples were collected at Day 1 and Day 7 and assayed for LIK066 concentrations using validated liquid chromatography-tandem mass spectrometry assays (LC MS/MS). The method will have an LLOQ of at least 5 ng/mL for LIK066. Concentrations were expressed in mass per volume units and refered to LIK066 plasma concentrations.~Cmax was determined using the actual recorded sampling times and non-compartmental method(s) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function. Only descriptive analysis done."|Day 1 and Day 7 (0 hour predose and 0.5, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0 and 12.0 hours post-dose)|Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least 1 valid PK concentration measurement, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2537560|NCT03131479|Primary|Change From Baseline in 24-hour Urinary Glucose Excretion (UGE) on Day 7|Urine was collected over 24 h to measure Urinary Glucose Excretion (UGE) at baseline (Day -1), following a single dose (Day 1) and at the end of the 7-day treatment (Day 7) to assess the effect of a 7 day treatment with LIK066 in subjects with decreased renal function compared to those with normal renal function.|Baseline , Day 7|Pharmacodynamic Analysis Set (PD), which consisted of all participants with an observed PD value, was considered. Only patients with evaluable data at each time point were analyzed for that time point.|||gram (g)||Standard Deviation|Mean
2537561|NCT03131206|Secondary|Peak Plasma Concentration (Cmax) of Alectinib|Cmax pharmacokinetic parameters will be estimated using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.|4 months|||||||
2537562|NCT03131206|Secondary|Duration of Response|Response evaluated using RECIST 1.1 Criteria|2 Years||2020-04-30|04/2020||||
2537563|NCT03131206|Secondary|Overall Survival|Overall survival is recorded from start of enrollment through study completion.|OS was calculated at the time of analysis, which was approximately 22 months after the study opened to enrollment.|Number of participants alive at time of analysis.|||Participants|||Count of Participants
2537564|NCT03131206|Secondary|Progression Free Survival|Progression evaluated using RECIST 1.1 Criteria|2 Years||2020-04-30|04/2020||||
2537565|NCT03131206|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of Alectinib|AUC pharmacokinetic parameters will be estimated using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.|4 months|||||||
2537566|NCT03131206|Primary|Objective Response Rate|Preliminary evaluation of objective response rate (ORR) of alectinib was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|8 weeks|Five participants were enrolled to the Phase 1 portion of the study and had imaging assessments performed; these 5 participants were evaluable for response rate.|||percentage of participants||95% Confidence Interval|Number
2537567|NCT03131206|Primary|Maximum Tolerated Dose (Phase 1)|The maximally administered dose (MAD) of the study medication will be defined as the dose level where at least two subjects develop toxicities consistent with a DLT definition. In this situation, the dose level immediately below the MAD will be defined as the MTD.|28 Days|5 patients were analyzed for the MTD, but the MTD was not reached due to incomplete enrollment (6 patients required to evaluate MTD, per protocol; study closed to enrollment after 5 participants were enrolled). There were no participants analyzed in the Phase 2 portion of the study (Cohorts A, B, and C), hence why those fields are NA.|||mg|||Number
2537568|NCT03131167|Secondary|Change From Baseline in Intra Ocular Pressure (IOP) at Day 29|IOP was measured using Goldmann applanation tonometry and reported data from baseline at day 29 for both study eye and non study eye.|Baseline, Day 29|Pharmacodynamic (PD) set consisted of all participants in the safety set for whom the primary PD data were evaluable.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2537570|NCT03129321|Secondary|Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure|To be considered a mycological cure the patient must have a negative KOH test and a negative fungal culture for T. rubrum, T. mentagrophytes or E. floccosum|Day 42|Modified Intent to Treat. Patients who are missing mycological culture data at baseline are not included in the analysis. Patients who are missing mycological culture data at the test of cure visit are not included in the analysis unless they were a treatment failure.|||Participants|||Count of Participants
2537571|NCT03129321|Secondary|Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1)|The following Clinical Signs and Symptoms of a target lesion with tinea pedis are individually rated for severity (none, mild, moderate, or severe): fissuring/cracking, erythema, maceration, scaling, pruritus, and burning/stinging|Day 42|Modified Intent to Treat|||Participants|||Count of Participants
2537572|NCT03129321|Secondary|Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure|To be considered a mycological cure the patient must have a negative KOH test and a negative fungal culture for T. rubrum, T. mentagrophytes or E. floccosum|Day 42|Active treatment groups of the Per Protocol population|||Participants|||Count of Participants
2537573|NCT03129321|Secondary|Proportion of Patients in Each Active Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1)|The following Clinical Signs and Symptoms of a target lesion with tinea pedis are individually rated for severity (none, mild, moderate, or severe): fissuring/cracking, erythema, maceration, scaling, pruritus, and burning/stinging|Day 42|Active treatment groups of the Per Protocol population|||Participants|||Count of Participants
2537574|NCT03129321|Primary|Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure|To be considered a Therapeutic Cure, the patient must have both Clinical Cure (patient's total severity score must be ≤ 2 with no individual severity score > 1) and Mycological Cure (patient must have a negative KOH test and a negative fungal culture) of tinea pedis|Day 42|Modified Intent to Treat. Patients who are missing mycological culture data at baseline are not included in the analysis. Patients who are missing mycological culture data at the test of cure visit are not included in the analysis unless they were a treatment failure.|||Participants|||Count of Participants
2537575|NCT03129321|Primary|Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure|To be considered a Therapeutic Cure, the patient must have both Clinical Cure (patient's total severity score must be ≤ 2 with no individual severity score > 1) and Mycological Cure (patient must have a negative KOH test and a negative fungal culture) of tinea pedis|Day 42|Active Treatments of the Per Protocol Population|||Participants|||Count of Participants
2537576|NCT03129178|Secondary|Establish Retention Rates|Establish retention rates (Descriptive statistics)|From date of randomization until the end of the last study visit. Estimated assesment period 6 - 52 weeks||||Participants|||Count of Participants
2537577|NCT03129178|Secondary|Feasible to Participants|Feasible to participants via interview. Specifically, semi-structured interviews explored participants' experiences of the study procedures and consumption of beetroot juice. Interviews were conducted by a researcher with experience in qualitative research methods. Interviews were recorded, transcribed verbatim, and analysed through thematic analysis as outlined by Braun and Clarke (2006).|During qualitative interviews after the intervention has ended (post day 36).|Qualitative outcome.|||Participants|||Count of Participants
2537578|NCT03129178|Secondary|Perceived Pain|"Perceived pain.~Pain sensation was assessed using a numerical rating scale for pain (0 no pain, 10 unimaginable, unspeakable pain; (Ferreira-Valente et al., 2011)) at the same time points."|Baseline (day 1), Acute (2 or 23), Chronic (day 16 or 36).||||score on a scale||Standard Deviation|Mean
2537579|NCT03129178|Secondary|Overall Number of Participants Recruited|Number of participants who remained in the study|From start of study recruitment until the last participant is randomised. Estimated assesment period 6 - 52 weeks||||Participants|||Count of Participants
2537580|NCT03129178|Secondary|Acceptability to Participants|Interview. Specifically, semi-structured interviews explored participants' experiences of the study procedures and consumption of beetroot juice. Interviews were conducted by a researcher with experience in qualitative research methods. Interviews were recorded, transcribed verbatim, and analysed through thematic analysis as outlined by Braun and Clarke (2006). Participants were asked about the testing procedures and their thoughts on the juice.|During qualitative interviews after the intervention has ended (post day 36).||||Participants|||Count of Participants
2537581|NCT03129178|Secondary|Perceived Discomfort|"Perceived discomfort.~Thermal discomfort were measured using a 20 cm scale (0 = very cold/uncomfortable; 10 = neutral; 20 = very hot/comfortable; modified from Zhang et al. (2004)) and recorded prior to immersion, during immersion and every 2 minutes of the rewarming period."|Baseline (day 1), Acute (2 or 23), Chronic (day 16 or 36).||||score on a scale||Standard Deviation|Mean
2537582|NCT03129178|Primary|Skin Temperature.|Skin temperature (via thermal imaging).|Baseline (day 1), Acute (2 or 23), Chronic (day 16 or 36).||||Degree Celsius||Standard Deviation|Mean
2537583|NCT03129178|Primary|Peripheral Blood Flow|Peripheral blood flow (CVC = skin flux/MAP; flux.mmHg-1).|Baseline (day 1), Acute (2 or 23), Chronic (day 16 or 36).|20 individuals with raynauds phenomenon. Result reported is Blood flow (CVC), 10 minutes after rewarming for the chronic exposures (Baseline (day 1), visit 2 (day 2), 3 (day 16), 4 (day 23) and 5 (day 36) respectfully).|||flux.mmHg-1||Standard Deviation|Mean
2537584|NCT03128723|Secondary|Cutaneous Tolerance Scores: Tightness/Dry|Cutaneous Tolerance Scores: Tightness/Dry Feeling (assessing skin tightness/dry feeling), from Baseline to Day 14. Scale range is 0-3 where 0 = no tightness/dry feeling, 1 = mild tightness/dry feeling, 2 = moderate tightness/dry feeling, and 3 = severe tightness/dry feeling.|Baseline to Day 14||||Units on a scale||Standard Error|Mean
2537585|NCT03128723|Secondary|Cutaneous Tolerance Scores: Itching|Cutaneous Tolerance Scores: Itching (assessing skin itching), from Baseline to Day 14. Scale range is 0-3 where 0 = no itching, 1 = mild itching, 2 = moderate itching, and 3 = severe itching.|Baseline to Day 14||||Units on a scale||Standard Error|Mean
2537586|NCT03128723|Secondary|Cutaneous Tolerance Scores: Burning/Stinging|Cutaneous Tolerance Scores: Burning/Stinging (assessing skin burning/stinging), from Baseline to Day 14. Scale range is 0-3 where 0 = no burning/stinging, 1 = mild burning/stinging, 2 = moderate burning/stinging, and 3 = severe burning/stinging.|Baseline to Day 14||||Units on a scale||Standard Deviation|Mean
2537587|NCT03128723|Secondary|Cutaneous Tolerance Scores: Edema|Cutaneous Tolerance Scores: Edema (assessing skin edema/swelling), from Baseline to Day 14. Scale range is 0-3 where 0 = no edema, 1 = mild edema, 2 = moderate edema, and 3 = severe edema.|Baseline to Day 14||||Units on a scale||Standard Deviation|Mean
2537591|NCT03128723|Primary|Cutaneous Tolerance Scores: Itching|Cutaneous Tolerance Scores: Itching (assessing skin itching), from Baseline to Day 28. Scale range is 0-3 where 0 = no itching, 1 = mild itching, 2 = moderate itching, and 3 = severe itching.|Baseline to Day 28||||Units on a scale||Standard Deviation|Mean
2537592|NCT03128723|Primary|Cutaneous Tolerance Scores: Burning/Stinging|Cutaneous Tolerance Scores: Burning/Stinging (assessing skin burning/stinging), from Baseline to Day 28. Scale range is 0-3 where 0 = no burning/stinging, 1 = mild burning/stinging, 2 = moderate burning/stinging, and 3 = severe burning/stinging.|Baseline to Day 28||||Units on a scale||Standard Deviation|Mean
2537593|NCT03128723|Primary|Cutaneous Tolerance Scores: Edema|Cutaneous Tolerance Scores: Edema (assessing skin edema/swelling), from Baseline to Day 28. Scale range is 0-3 where 0 = no edema, 1 = mild edema, 2 = moderate edema, and 3 = severe edema.|Baseline to Day 28||||Units on a scale||Standard Deviation|Mean
2537594|NCT03128723|Primary|Cutaneous Tolerance Scores: Dryness/Scaling|Cutaneous Tolerance Scores: Dryness/Scaling (assessing skin dryness), from Baseline to Day 28. Scale range is 0-3, where 0 = no dryness, 1 = mild dryness, 2 = moderate dryness, and 3 = severe dryness.|Baseline to Day 28||||Units on a scale||Standard Deviation|Mean
2537595|NCT03128723|Primary|Cutaneous Tolerance Scores: Erythema|Cutaneous Tolerance Scores: Erythema (assessing skin redness), from Baseline to Day 28. Scale range is 0-3 where 0 = no redness, 1 = mild redness, 2 = moderate redness, and 3 = severe redness.|Baseline to Day 28||||Units on a scale||Standard Deviation|Mean
2537596|NCT03128372|Primary|Validated the Next Generation Oximeter|Cerebral overall mean bias (percentage saturation) defined as the average of the differences between the regional saturation (rSO2) value and (fSO2) value obtained from simultaneous arterial and jugular venous blood samples. Cerebral trending is defined as the measurement of changes in regional saturation (rSO2) under conditions of changing fSO2. Cerebral trending mean bias is the average difference between changes in rSO2 values compared against changes in fSO2. Somatic trending mean bias is defined the same as Cerebral trending mean bias except for the location of measurement on the subjects and for Somatic trending mean bias, rS02 was compared to rSO2 on a commercially-available regional oximetry monitor. The smaller value the better performance.|Data collected from individual participant over 4 hour timeframe.||||Percentage saturation||Standard Deviation|Mean
2537597|NCT03128307|Primary|Visual-Analogue Scale, Self-Reported Snoring Habits|Quantitative assessment on 1-10 scale. Outcome measurement reported as a percentage change from pre-trial with use of the device. A negative ('-') percentage would indicate a reduction in snoring symptoms as measured by the VAS, while a positive percentage ('+') result would indicate an increase in the measured symptom.|Baseline and 10 Days||||percent change|||Number
2537598|NCT03128307|Primary|Snoring Severity Scale|"The Snoring Severity Scale (SSS) is a 9-point, validated scale to measure the severity of snoring. A total of three questions are asked: 1) How often do you snore, 2) How long do you snore, and 3) How audible is your snoring. Answers for each of these questions are summed for a total SSS score. A score of '0' would indicate no snoring at all, while a score of '9' would indicate the most severe snoring as measured by the SSS.~Outcome measure reported as change with use of the device over pre-trial. In this case, a negative ('-') would represent improvement in snoring symptoms, while a positive ('+') number would indicate an increase in snoring severity."|Baseline and 10 Days||||units on a scale||Standard Deviation|Mean
2537599|NCT03128099|Primary|Social Attention: Social Engagement Latency (SEL)|"Social Engagement Latency (SEL), defined as the time taken to select an avatar by fixating eye gaze at the chosen avatar's face to initiate a new social 'mission'. This is an ecologically valid index that corresponds to one's readiness to initiate a social interaction.~To start a social 'mission', the participant must choose an avatar by fixating on a semi-transparent green patch that covers the avatar's face. When the participant fixates on the avatar's face, the green patch disappears to reveal the avatar's face, which starts the social mission game.~The time takes to remove the green patch to reveal the avatar's face is the SEL, our primary social attention target and a useful index of pro-social attention engagement."|5 weeks|NB: We did not run high dose condition due to the feasibility problem. Control participants do not undergo training. Therefore only the results of the low dose condition are reported|||msec||Standard Deviation|Mean
2537600|NCT03128008|Secondary|Local Control With an Accelerated and Adaptive RT Approach|The local control rate for the same cohort of subjects will be measured by standard of care imaging per NCCN guidelines at routine follow up clinic visits.|2 years|||||||
2537601|NCT03128008|Secondary|Progression-free Survival (PFS) With an Accelerated and Adaptive RT Approach.|Median progression-free survival for subjects will be characterized by Kalan-Meier estimator. The median PFS will be estimated as well as their 95% confidence intervals.|2 years|||||||
2537602|NCT03128008|Secondary|Overall Survival With an Accelerated and Adaptive RT Approach.|The overall survival (OS) for the treated subjects will be characterized by Kalan-Meier estimator. The medial OS will be estimated with a 95% confidence interval.|2 years|||||||
2537603|NCT03128008|Secondary|The Number of Subjects Eligible for an RT Boost After Completing a Standard Dose of RT (60 Gy), Delivered in an Accelerated Fashion (6 Fractions/Week) With Concurrent Chemotherapy|In the same subject cohort, the proportion of the subjects who are eligible for an RT boost after completing a standard dose of RT (60 Gy), delivered in an accelerated fashion (6 fractions/week) with concurrent chemotherapy, will be estimated as well as its confidence interval.|4 weeks|9 participants indicated whether they had Boost or not|||Participants|||Count of Participants
2537604|NCT03128008|Primary|The Metabolic Complete Response Rate, Assessed Using Interim PET-CT, in an Accelerated Fashion (2 Gy/Fraction, 6 Fractions/Week) With Concurrent Chemotherapy|For the cohort of the subjects who meet eligibility criteria and receive radiotherapy with concurrent chemotherapy, the metabolic complete response (MCR) rate will be measured with interim PET-CT utilizing PERCIST response reporting criteria.|4 weeks|8 participants have RECIST measurements available|||Participants|||Count of Participants
2537605|NCT03127956|Primary|Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions|Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions|Day 1 - Week 36|Safety Population|||Participants|||Number
2537606|NCT03127943|Primary|Mean Time to Pulpal Response After Mandibular Canine Anesthesia|Subjects' mandibular molar teeth will be tested before anesthetic and every 30 minutes with cold and electric pulp test for presence of anesthesia as reported by subjects yes or no|30 minute intervals up to 120 minutes||||minutes||Standard Deviation|Mean
2537607|NCT03127943|Primary|Mean Time to Pulpal Response After Mandibular Molar Anesthesia|Subjects' mandibular molar teeth will be tested before anesthetic and every 30 minutes with cold and electric pulp test for presence of anesthesia as reported by subjects yes or no|Every 30 minutes up to 120 minutes Total||||minutes||Standard Deviation|Mean
2537609|NCT03127644|Secondary|Time to Normalisation in S-K Values|The distribution of time to normalisation of S-K values (defined as S-K values between 3.5 mmol/L and 5.0 mmol/L, inclusive) was measured. A patient who reached at least one S-K within normal range was counted as an event regardless of S-K value after that time point. Patients who did not achieve normokalaemia within 48 hours were censored.|From 0 to 48 hours.|The full analysis set included all patients randomised in the study.|||Hours||95% Confidence Interval|Median
2537610|NCT03127644|Secondary|Mean Percent Change From Baseline in S-K Values at All Measured Time Intervals|Blood samples for determination of potassium were collected pre-dose, and at 1, 2, and 4 hours post Dose 1 on Day 1. An additional sample was collected at 90 minutes post Dose 2 on Day 1 if i-STAT potassium values at the 4-hour post Dose 1 time point was ≥ 6.1 or <4.0 mmol/L. On Day 2 samples were analysed pre-dose, and 1 and 4 hours post Dose 1. S-K levels were analysed locally using i-STAT devices, and at the Central Laboratory. S-K values measured at each time point and end of study visit were recorded and mean percent change from baseline is displayed.|From baseline to end of study (9 days).|The full analysis set included all patients randomised in the study.|||Percent change||Standard Deviation|Mean
2537611|NCT03127644|Secondary|Mean Change From Baseline in S-K Values at All Measured Time Intervals|Blood samples for determination of potassium were collected pre-dose, and at 1, 2, and 4 hours post Dose 1 on Day 1. An additional sample was collected at 90 minutes post Dose 2 on Day 1 if i-STAT potassium values at the 4-hour post Dose 1 time point was ≥ 6.1 or <4.0 mmol/L. On Day 2 samples were analysed pre-dose, and 1 and 4 hours post Dose 1. S-K levels were analysed locally using i-STAT devices, and at the Central Laboratory. S-K values measured at each time point and end of study visit were recorded and mean change from baseline is displayed.|From baseline to end of study (9 days).|The full analysis set included all patients randomised in the study.|||mmol/L||Standard Deviation|Mean
2537612|NCT03127644|Secondary|Percentage of Patients Who Achieved Normokalaemia at Each Scheduled Potassium Assessment Time Point|The percentage of patients who achieved normokalaemia (normalisation of S-K values to between 3.5 mmol/L and 5.0 mmol/L, inclusive) at each each scheduled potassium assessment time point after the start of dosing was determined. Patients with missing S-K values were regarded as not normokalaemic.|From baseline to end of study (9 days).|The full analysis set included all patients randomised in the study.|||Percentage of Patients|||Number
2537613|NCT03127644|Secondary|Percentage of Patients Who Achieved Normokalaemia at 24 Hours|The percentage of patients who achieved normokalaemia (normalisation of S-K values to between 3.5 mmol/L and 5.0 mmol/L, inclusive) at 24 hours after start of dosing was determined. Patients with missing S-K values at 24 hours were regarded as not normokalaemic.|At 24 hours.|The full analysis set included all patients randomised in the study.|||Percentage of Patients|||Number
2537614|NCT03127644|Secondary|Exponential Rate of Change in S-K Values During the Initial 24 Hours of Study Drug Treatment|Blood samples for determination of potassium were collected pre-dose, and at 1, 2, and 4 hours post Dose 1 on Day 1. An additional sample was collected at 90 minutes post Dose 2 on Day 1 if i-STAT potassium values at the 4-hour post Dose 1 time point was ≥ 6.1 or <4.0 mmol/L. On Day 2 samples were analysed pre-dose, and 1 and 4 hours post Dose 1. S-K levels were analysed at the Central Laboratory. Natural logarithm of S-K from 0 to 24 hours post dose are modelled by the random coefficients model including fixed effects of intercept, time, time x treatment and patient-level random effects for time and intercept. Exponential rate of change refers to the slope estimate from the random coefficients model.|From 0 to 24 hours.|The full analysis set included all patients randomised in the study.|||log (mmol/L) / hour||Standard Error|Mean
2537615|NCT03127644|Secondary|Percentage of Patients Who Achieved Normokalaemia at 48 Hours|The percentage of patients who achieved normokalaemia (normalisation of S-K values to between 3.5 mmol/L and 5.0 mmol/L, inclusive) at 48 hours after start of dosing was determined. Patients with missing S-K values at 48 hours were regarded as not normokalaemic.|At 48 hours.|The full analysis set included all patients randomised in the study.|||Percentage of Patients|||Number
2537616|NCT03127644|Primary|Exponential Rate of Change in Serum Potassium (S-K) Values During the Initial 48 Hours of Study Drug Treatment|"Blood samples for determination of potassium were collected pre-dose, and at 1, 2, and 4 hours post Dose 1 on Day 1. An additional sample was collected at 90 minutes post Dose 2 on Day 1 if i-STAT potassium values at the 4-hour post Dose 1 time point was ≥ 6.1 or <4.0 mmol/L. On Day 2 samples were analysed pre-dose, and 1 and 4 hours post Dose 1. S-K levels were analysed at the Central Laboratory.~Natural logarithm of S-K from 0 to 48 hours post dose are modelled by the random coefficients model including fixed effects of intercept, time, time x treatment and patient-level random effects for time and intercept. Exponential rate of change refers to the slope estimate from the random coefficients model."|From 0 to 48 hours.|The full analysis set included all patients randomised in the study.|||log (mmol/L) / hour||Standard Error|Mean
2537617|NCT03127384|Secondary|Percentage of Participants Improved on the Global Aesthetic Improvement Scale (GAIS)|Assessed by blinded evaluator|Month 1, Month 3|48 participants at Month 1, 47 participants at Month 3, due to withdrawal. Split-face design: overall 48 participants, with one treated cheek and one cheek as no-treatment control.|||percentage of participants|cheeks|95% Confidence Interval|Number
2537618|NCT03127384|Primary|Percentage of Participants With Lower Scar Severity in the Treated Cheek Compared to the Untreated Cheek|Overall scar severity assessed by blinded evaluator.|Month 3||||percentage of participants||95% Confidence Interval|Number
2537619|NCT03127228|Primary|Change in Radiographic Bone Fill (RBF)|Peri-implant bony defect change will be measured compared to baseline. Participants' standardized radiographs were used to determine bone level changes between baseline and 24 weeks.|Baseline and 24 Week||||Millimeters|Implants|Standard Deviation|Mean
2537620|NCT03127228|Primary|Change in Bleeding on Probing (BOP)|BOP will be measured dichotomously as 0 or 1. Score 0=no bleeding present Score 1=bleeding present Change in subject BOP score was calculated between baseline and 24 weeks and reported as percent of sites with BOP.|Baseline and 24 Week||||percentage of sites with BOP|Implants|Standard Deviation|Mean
2537621|NCT03127228|Primary|Change in Clinical Attachment Level (CAL)|CAL will be measured in millimeters. Change in subject CAL measurements were calculated between baseline and 24 weeks.|Baseline and 24 Week||||millimeters|Implants|Standard Deviation|Mean
2537622|NCT03127228|Primary|Change in Periodontal Probing Depths (PD)|PD will be measured in millimeters. Change in PD measurements were calculated between baseline and 24 weeks.|Baseline and 24 Week||||millimeters|Implants|Standard Deviation|Mean
2537623|NCT03126682|Secondary|Change in MADRS Score|Scoring of depressive symptoms on the Montgomery Asberg Depression Rating Scale, maximum 60 , minimum 0. Higher scores mean worse outcome. First measurement on day 1 of electroconvulsive treatment (ECT) and second measurement on day 2 of electroconvulsive therapy (ECT), separated by 1 day interval. This outcome measure was not measured at baseline.|Scored on day 1 and day 2 after ECT session||||Scored on a scale||Standard Deviation|Mean
2537624|NCT03126682|Primary|Change in Seizure Duration|Duration of seizures with ECT. First measurement on day 1 of electroconvulsive treatment (ECT) and second measurement on day 2 of electroconvulsive therapy (ECT), separated by 1 day interval. This outcome measure was not measured at baseline.|Measured at day 1 and day 2||||seconds||Standard Deviation|Mean
2537625|NCT03126682|Primary|Change in Seizure Threshold|Charge in Millicoulombs at which subject gets a seizure with ECT. First measurement on day 1 of electroconvulsive treatment (ECT) and second measurement on day 2 of electroconvulsive therapy (ECT), separated by 1 day interval. This outcome measure was not measured at baseline.|Measured at day 1 and day 2||||millicoulombs||Standard Deviation|Mean
2537626|NCT03126539|Secondary|Gene Expression Changes as Assessed by Immunohistochemistry (IHC)|We will measure the fold-change in gene expression in human skin after acute UV light exposure, separately and in combination with application of topical sulforaphane using IHC.|Up to 6 months|Data for this outcome measure was not collected.||||||
2537627|NCT03126539|Secondary|Gene Expression Changes as Assessed by Quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR)|We will measure the fold-change in gene expression in human skin after acute UV light exposure, separately and in combination with application of topical sulforaphane using RT-PCR.|Up to 6 months|Data for this outcome measure was not collected.||||||
2537628|NCT03126539|Primary|Clinical Change Score for Mottled Hyperpigmentation|Clinical assessment of mottled hyperpigmentation pre and post Sulforaphane (SF) treatment will be done for both photoprotected and photodamaged skin treated with sulforaphane. Mottled Hyperpigmentation Score system will be applied, with scale of 0 to 4, 4= clear improvement after 1 week of SF or placebo application.|Clinical Change Score for Mottled Hyperpigmentation , up to 1 week|We did not enroll any participant in group B. The results we got were not the comparison between no UV exposure group and UV exposure. Instead, the results were the clinical change score between the SF treated skin spots and no SF treated (placebo) skin spots of each participant.|||score on a scale|Skin spots|Standard Error|Mean
2537629|NCT03126448|Primary|Number of Participants With Tissue Samples Identified With Bacterial DNA According to Highly Sensitive Bacterial Assays|The objective of this research is to see if highly sensitive bacterial assays are useful for determining whether fracture nonunions are infected|Study surgery to 6-month clinical follow-up||||Participants|||Count of Participants
2537630|NCT03125941|Secondary|Readmission|Any readmission, days 0-30|30 days||||Participants|||Count of Participants
2537631|NCT03125941|Secondary|Number of Participants With Seroma, Requiring Treatment|Seroma, requiring treatment the first 14 days.|14 days||||Participants|||Count of Participants
2537632|NCT03125941|Secondary|Mental Status|Self-reported feelings of restlessness, sadness and fatigue (days 0-4). Questionnaire (anwers possible: yes or no. Numbers are patients answering yes)|days 0-4||||Participants|||Count of Participants
2537633|NCT03125941|Secondary|Quality of Sleep|Self-reported quality of sleep (days 0-4). Questionnaire. Dichotomized to Good sleep or sleep problems, numbers reported are number of patients with sleep problems|days 0-4||||Participants|||Count of Participants
2537634|NCT03125941|Secondary|Post Operative Nausea and Vomiting (PONV).|Self-reported nausea, questionnaire, day 0-4. Number of participants reporting nausea and/or vomiting|days 0-4||||Participants|||Count of Participants
2537635|NCT03125941|Secondary|Pain, Numeric Rating Scale|Self-reported pain (worst and average (average through that day), days 0-4) on a numeric rating scale (NRS) 0-10. 0 is no pain, 10 is worst pain imaginable.. Questionnaire.|days 0-4||||score on a scale||Inter-Quartile Range|Median
2537636|NCT03125941|Secondary|Secondary Transfer|Secondary transfer to PACU from ward, or to intensive care unit from PACU|24-48 hours||||Participants|||Count of Participants
2537637|NCT03125941|Secondary|Total Length of Stay in Hospital|Length of stay in hospital, measured from start of procedure to discharge from hospital to home|24-48 hours||||hours||Inter-Quartile Range|Median
2537638|NCT03125941|Secondary|Total Length of Stay in PACU|Length of stay in the post-anesthesia care unit (PACU), measured as hours and minutes, from start of procedure, to discharge from PACU|12 hours||||hours||Inter-Quartile Range|Median
2537639|NCT03125941|Secondary|Number of Participants With Complication|complications requiring treatment until discharge|24 hours||||Participants|||Count of Participants
2537640|NCT03125941|Secondary|Discharge Score, Arrival at Ward|"DASAIM score (Danish Society of Anesthesiology and Intensive Care Medicine). The score consists of six modalities: Sedation, Oxygen saturation, blood pressure, heart rate, pain (at rest) and nausea.~Each modality has a score between 0 and 3, and patients are considered dischargeable to the ward when the score sum of all criteria is four or less and no single score is above one.~Sedation: 0 fully awake, 1, sleeping aroused by verbal stimuli, 2 sleeping, aroused by physical stimuli, 3 sleeping, cannot be aroused.~Oxygen saturation (%): 0 ≥ 94, 1 90-93, 2 85-89, 3 <85. Blood pressure, systolic (mmHg): 0 100-220, 1 90-99. 2 80-89 or >220, 3<80. Heart rate; pr. min: 0 50-100, 1 101-120, 2 40-49 or 121-130, 3 <40 or >130. Pain (at rest) (Numeric rating scale 0-10): 0 0, 1 0-2, 2 3-6, 3 ≥ 7 Nausea (patient evaluation and nurse observation): 0 none, 1 light, 2 moderate, 3 severe or vomiting."|within 3 hours||||score on a scale||Inter-Quartile Range|Median
2537641|NCT03125941|Secondary|Discharge Score, Arrival at PACU|"DASAIM score (Danish Society of Anesthesiology and Intensive Care Medicine). The score consists of six modalities: Sedation, Oxygen saturation, blood pressure, heart rate, pain (at rest) and nausea.~Each modality has a score between 0 and 3, and patients are considered dischargeable to the ward when the score sum of all criteria is four or less and no single score is above one.~Sedation: 0 fully awake, 1, sleeping aroused by verbal stimuli, 2 sleeping, aroused by physical stimuli, 3 sleeping, cannot be aroused.~Oxygen saturation (%): 0 ≥ 94, 1 90-93, 2 85-89, 3 <85. Blood pressure, systolic (mmHg): 0 100-220, 1 90-99. 2 80-89 or >220, 3<80. Heart rate; pr. min: 0 50-100, 1 101-120, 2 40-49 or 121-130, 3 <40 or >130. Pain (at rest) (Numeric rating scale 0-10): 0 0, 1 0-2, 2 3-6, 3 ≥ 7 Nausea (patient evaluation and nurse observation): 0 none, 1 light, 2 moderate, 3 severe or vomiting."|within 3 hours||||score on a scale||Inter-Quartile Range|Median
2537642|NCT03125941|Secondary|Discharge Score,(Modified Aldrete Discharge Score), Operating Room|"Danish Society of Anesthesiology and Intensive Care Medicine (DASAIM) discharge score.Construct: The score consists of six modalities (subscores): Sedation,Oxygen saturation,blood pressure,heart rate,pain (at rest)and nausea.Each modality has a score between 0 and 3,and patients are considered dischargeable to the ward when the score sum of all criteria (total score) is 4 or less and no single score is above 1. All values (subscores) are considered best at 0 and worst at 3.~Sedation: 0 fully awake, 1, sleeping aroused by verbal stimuli, 2 sleeping aroused by physical stimuli, 3 sleeping cannot be aroused.~Oxygen saturation (%):0 ≥94, 1 90-93, 2 85-89, 3 <85. Blood pressure, systolic (mmHg): 0 100-220, 1 90-99. 2 80-89 or >220, 3<80. Heart rate; pr. min: 0 50-100, 1 101-120, 2 40-49 or 121-130, 3 <40 or >130. Pain (at rest) (Numeric rating scale 0-10): 0 0, 1 0-2, 2 3-6, 3 ≥ 7 Nausea (patient evaluation and nurse observation): 0 none, 1 light, 2 moderate, 3 severe or vomiting."|At transfer from operating room, within 1 hour post-surgery||||score on a scale||Inter-Quartile Range|Median
2537643|NCT03125941|Primary|Transfer to Post-anesthesia Care Unit (PACU)|Number of patients meeting criteria for transfer to PACU post-surgery|Within 1 hour post-surgery|primary outcome was per intention to treat, secondary outcomes were per protocol (we had 3 post-randomization exclusions, that did not receive the intervention)|||Participants|||Count of Participants
2537644|NCT03125915|Secondary|Communication Skills|Couples Communication as assessed using the Communication Patterns Questionnaire and Individual Communication assessed using the Interpersonal Communication Competence|30 days prior to assessment||2020-01-31|01/2020||||
2537645|NCT03125915|Primary|Drug Abuse Screening Test-10 Total Scores|The scale assesses the number of drug use related problems experienced by the participant in the 30 days prior to the assessment. Higher scores indicate a greater number of drug use related problems. Note, assessments were conducted at 1, 3, and 6 months post intervention.|30 days prior to assessment|n reported is the number retained at each follow-up wave.|||score on a scale||Standard Deviation|Mean
2537646|NCT03125915|Primary|Condomless Anal Sex With Casual Partners|The outcome measure is a dichotomous variable indicating whether or not each participant indicated the occurrence of any insertive or receptive condomless anal sex (CAS) with a casual partner in the 30 days prior to each follow-up assessment. The table below displays the number (and percentage) of participants who indicated any CAS with a casual partner at each assessment wave. Assessments were conducted at 1, 3, and 6 month post intervention.|30 days prior to assessment|n reported is number retained at each wave|||Participants|||Count of Participants
2537647|NCT03125915|Primary|Proportion of Respondents Reporting Any Drug Use|The outcome measure is a dichotomous variable indicating whether or not each participant reported any drug use in the in the 30 days prior to each follow-up assessment. The table below displays the number (and percentage) of participants who indicated the use of any drugs at each assessment wave. Assessments were conducted at 1, 3, and 6 month post intervention.|30 days prior to assessment|Intent to treat analysis conducted using latent growth curve modeling to examine between-group differences in follow-up rates of drug use and trajectories of use over the follow-up period.|||Participants|||Count of Participants
2537648|NCT03125200|Secondary|Anti-drug Antibody (ADA) Titers to ADCT-502||Blood sample collection before start of infusion in Cycles 1 and 2, and on Day 1 starting with Cycle 3 until disease progression, 30 days and 12 weeks after last dose|This analysis was planned but data was not collected as the study was terminated due to safety reasons.||||||
2537649|NCT03125200|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) for Free Warhead SG3199||Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose|This analysis was planned but data was not collected as the study was terminated due to safety reasons.||||||
2537650|NCT03125200|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) for PBD-conjugated Antibody (DAR ≥1)||Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose|This analysis was planned but data was not collected as the study was terminated due to safety reasons.||||||
2537651|NCT03125200|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) for Drug To-antibody Ratio [DAR] ≥0)||Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose|This analysis was planned but data was not collected as the study was terminated due to safety reasons.||||||
2537652|NCT03125200|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) for ADCT-502 (Total Antibody)||Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose|This analysis was planned but data was not collected as the study was terminated due to safety reasons.||||||
2537653|NCT03125200|Secondary|Maximum Observed Plasma Concentration (Cmax) for Free Warhead SG3199||Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose|This analysis was planned but data was not collected as the study was terminated due to safety reasons.||||||
2537654|NCT03125200|Secondary|Maximum Observed Plasma Concentration (Cmax) for PBD-conjugated Antibody (DAR ≥1)||Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose|This analysis was planned but data was not collected as the study was terminated due to safety reasons.||||||
2537655|NCT03125200|Secondary|Maximum Observed Plasma Concentration (Cmax) for Drug To-antibody Ratio [DAR] ≥0||Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose|This analysis was planned but data was not collected as the study was terminated due to safety reasons.||||||
2537656|NCT03125200|Secondary|Maximum Observed Plasma Concentration (Cmax) for ADCT-502 (Total Antibody)||Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose|This analysis was planned but data was not collected as the study was terminated due to safety reasons.||||||
2537657|NCT03125200|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of Free Warhead SG3199||Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose|This analysis was planned but data was not collected as the study was terminated due to safety reasons.||||||
2537658|NCT03125200|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of PBD-conjugated Antibody (DAR ≥1)||Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose|This analysis was planned but data was not collected as the study was terminated due to safety reasons.||||||
2537659|NCT03125200|Secondary|Area Under the Plasma Concentration Time Curve (AUC) of Drug To-antibody Ratio [DAR] ≥0||Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose|This analysis was planned but data was not collected as the study was terminated due to safety reasons.||||||
2537660|NCT03125200|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of ADCT-502 (Total Antibody)||Before infusion, End of Infusion, and 1, 3, 6, 24, 48, 96, 168 and 336 hours post infusion for Cycle 1 & 2. Before infusion and end of infusion of Cycle 3 to disease progression, and 30 days and 12 weeks after last dose|This analysis was planned but data was not collected as the study was terminated due to safety reasons.||||||
2537661|NCT03125200|Secondary|Overall Survival (OS)|Median OS was defined as the time from the beginning of study drug treatment until death due to any cause.|Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks|This analysis was planned but data was not collected as the study was terminated due to safety reasons.||||||
2537662|NCT03125200|Secondary|Progression-Free Survival (PFS)|PFS was defined among the efficacy population as the time from first dose of study drug until the first date of either disease progression or death due to any cause.|Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks|This analysis was planned but data was not collected as the study was terminated due to safety reasons.||||||
2537663|NCT03125200|Secondary|Duration of Response (DOR)|DOR was defined among responders (CR or PR) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause.|Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks|This analysis was planned but data was not collected as the study was terminated due to safety reasons.||||||
2537664|NCT03125200|Secondary|Disease Control Rate (DCR)|DCR was defined as the number of participants with a best overall response of Complete Response (CR) or Partial Response (PR), or Stable Disease (SD). Analysis will be determined by the investigator per Response Evaluation In Solid Criteria (RECIST) version 1.1 criteria: stable disease is when the change is > -30% and ≤ 20%, partial response is when there is a decrease in sum of target disease ≥ 30%, and complete response is when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each.|Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks||||Participants|||Count of Participants
2537665|NCT03125200|Secondary|Overall Response Rate (ORR)|ORR was defined as the number of participants with a best overall response of Complete Response (CR) or Partial Response (PR) at the time each participant discontinues ADCT-502. Analysis will be determined by the investigator per Response Evaluation In Solid Criteria (RECIST) version 1.1 criteria: partial response is when there is a decrease in sum of target disease ≥ 30%, and complete response is when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each.|Screening, day 1 of cycle 3 and cycle 5, then every 4 cycles, approximately every 12 weeks||||Participants|||Count of Participants
2537666|NCT03125200|Primary|Number of Participants Who Experience Clinically Significant Electrocardiogram (ECG) Results|Standard 12-lead ECG's will be used. Clinical significance was determined by the investigator.|Day 1 to end of trial, a maximum of 168 days (+ 30 days)||||Participants|||Count of Participants
2537667|NCT03125200|Primary|Number of Participants With Clinically Significant Vital Signs|Vital sign measurements include arterial blood pressure, heart rate, respiratory rate, and body temperature. Clinical significance was determined by the investigator.|Day 1 to end of trial, a maximum of 168 days (+ 30 days)||||Participants|||Count of Participants
2537668|NCT03125200|Primary|Number of Participants Who Experience a Clinically Significant Change in Eastern Cooperative Oncology Group (ECOG) Performance Status|Performance status was assessed using the ECOG performance status grades. These range between Grade 0 (fully active) and Grade 5 (dead). Clinical significance was determined by the investigator.|Day 1 to end of trial, a maximum of 168 days (+ 30 days)|This analysis was planned but data was not collected as the study was terminated due to safety reasons.||||||
2537669|NCT03125200|Primary|Number of Participants With Clinically Significant Physical Examination Results|Clinical significance was determined by the investigator.|Day 1 to end of trial, a maximum of 168 days (+ 30 days)|This analysis was planned but data was not collected as the study was terminated due to safety reasons.||||||
2537670|NCT03125200|Primary|Number of Participants With Clinically Significant Clinical Laboratory Tests|Clinical significance was determined by the investigator.|Day 1 to end of trial, a maximum of 168 days (+ 30 days)|This analysis was planned but data was not collected as the study was terminated due to safety reasons.||||||
2537671|NCT03125200|Primary|Number of Participants Who Experience At Least One Treatment Emergent Serious Adverse Event (SAE)||Day 1 to end of trial, a maximum of 168 days (+ 30 days)||||Participants|||Count of Participants
2537672|NCT03125200|Primary|Number of Participants Who Experience At Least One Treatment Emergent Adverse Event (TEAE)|An adverse event is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 to end of trial, a maximum of 168 days (+ 30 days)||||Participants|||Count of Participants
2537673|NCT03125200|Primary|Number of Participants Who Experienced a Dose-Limiting Toxicity With a CTCAE Grade of 3 or Above|The Common Terminology Criteria For Adverse Events (CTCAE) Version 4 will be used.|Day 1 to 3 Weeks (one cycle)||||Participants|||Count of Participants
2537674|NCT03125200|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities||Day 1 to 3 Weeks (one cycle)||||Participants|||Count of Participants
2537675|NCT03125031|Primary|Accuracy of Noninvasive Sensors by Arms Calculation|Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. The accuracy results from both sensors will be assessed for equivalence|1-5 hours||||g/dL|data points||Number
2537676|NCT03125018|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours||||% of oxygen saturated hemoglobin|data points||Number
2537677|NCT03125005|Primary|Accuracy of Sensor by Arms Calculation|Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.|5 hours||||Percentage of total hemoglobin|||Number
2537678|NCT03124979|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours||||% of oxygen saturated hemoglobin|data points||Number
2537679|NCT03124966|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.|1-3 hours||||g/dL|||Number
2537680|NCT03124927|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive blood methemoglobin measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.|5 hours||||percentage|||Number
2537681|NCT03124901|Primary|Accuracy of Sensor|Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.|Up to 24 hours||||g/dL|||Number
2537682|NCT03124836|Primary|Accuracy of Methemoglobin Measurement by Arms Calculation|Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.In order to obtain the Arms value, the blood sample methemoglobin value is subtracted from the pulse oximeter methemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours||||percentage of total hemoglobin|||Number
2537683|NCT03124823|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours||||% of oxygen saturated hemoglobin|data points||Number
2537684|NCT03124797|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours||||% of oxygen saturated hemoglobin|data points||Number
2537685|NCT03124784|Primary|SpO2 ARMS of Sensor Under Motion Conditions|Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square error (Arms) value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.|1-5 hours|2 subjects were excluded from data analysis: one due to adverse event and the other due to equipment malfunction.|||% of oxygen saturated hemoglobin|||Number
2537686|NCT03124771|Primary|Accuracy of Sensor by Arms Calculation|Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.|1-5 hours||||g/dL|data points||Number
2537687|NCT03124758|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.|1-5 hours||||g/dL|data points||Number
2537688|NCT03124693|Primary|Accuracy of Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.|Up to 24 hours||||g/dL|||Number
2545590|NCT02940327|Primary|CD16/41|Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.|24 hours after decannulation||||percentage change||Standard Deviation|Mean
2537689|NCT03124602|Primary|Accuracy of Red Diamond Disposable Pulse Oximeter Sensor by Arms Calculation|Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the Accuracy root mean square (ARMS) error value. In order to obtain the Arms value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the ARMS Error value.|1-5 hours per subject||||percent of oxygen saturated hemoglobin|||Number
2537690|NCT03124563|Secondary|Exercise Self-efficacy Beliefs - Time Composite|Amount of confidence in ability to exercise when facing time constraints. Range from 1 (Very Sure) to 4 (Not sure at all). Reverse coded so that a higher number indicates more self-efficacy. 3 items, summed to form time-relevant composite scale.|Baseline (Pre-Test) and Week 5 (Post-Test )|Analysis population based on those who completed Exercise Self-efficacy Beliefs questionnaire at each testing point.|||units on a scale||Standard Deviation|Mean
2537691|NCT03124563|Secondary|Exercise Self-efficacy|Amount of confidence in ability to exercise.|Baseline (Pre-Test) and Week 5 (Post-Test )||||units on a scale||Standard Deviation|Mean
2537692|NCT03124563|Secondary|Exercise Control Beliefs|Degree of perceived control over Exercise. Range from 1 (Strongly agree) to 5 (strongly agree). Reverse coded so that a higher number indicates more perceived control over exercise.|Baseline (Pre-Test) and Week 5 (Post-Test )|Analysis population based on those who completed Control Beliefs over Exercise questionnaire at each testing point.|||units on a scale||Standard Deviation|Mean
2537693|NCT03124563|Secondary|Cognitive Composite Score|Z-score composite on the Brief Test of Adult Cognition by Telephone (BTACT). Individual tests scores were first standardized to z-scores. The z-score composite was calculated by averaging the z-scores of the 5 tests: word list immediate, word list delayed, backwards counting, digits backwards, and category fluency. Post-test z-scores were standardized based on the mean and s.d. of the pretest scores. A higher z-score is indicative of better cognitive functioning.|Baseline (Pre-Test) and Week 5 (Post-Test )|Analysis population based on those who completed cognitive test at each testing point.|||Z-score||Standard Deviation|Mean
2537694|NCT03124563|Primary|Activity Intensity|Weekly average of daily time spent in moderate to vigorous intensity activity (averaged across 7 days at Week 1 and averaged across 7 days at Week 5).|Week 1 & Week 5|Analysis population based on participants that successfully synced their Fitbit and did not withdraw before the start of the study.|||Minutes||Standard Deviation|Mean
2537695|NCT03124563|Primary|Steps|Weekly average of daily step counts with Fitbit (averaged across 7 days at Week 1 and averaged across 7 days at Week 5).|Week 1 & Week 5|Analysis population based on participants that successfully synced their Fitbit and did not withdraw before the start of the study.|||Daily Steps||Standard Deviation|Mean
2537696|NCT03124407|Secondary|Percentage of Subjects With 50% or Greater Pain Score Reduction From Baseline to Day 28 Post Study Drug Treatment.|To evaluate the percentage of subjects who experience ≥50% reduction in osteoarthritis knee pain in the target knee compared with baseline after 28 days. Subjects in the once daily application group recorded their knee pain in a diary twice: at 12 hrs (± 1 hr) after their initial application and then again within ≤30 minutes before their daily topical application which was to be applied at 24 hrs (± 1 hr) after their previous day's application on all subsequent study days. Subjects in the twice daily application group recorded their knee pain in a diary within ≤30 minutes before each application on all study days. Subjects used a 100mm visual analogue scale when assessing their knee pain.|Study Days 1-28|The analysis population included all subjects who received at least one application of study drug and reported any pain scores during the study.|||percentage of subjects|||Number
2537697|NCT03124407|Secondary|Percentage of Subjects With 50% or Greater Pain Score Reduction From Baseline to Day 8 Post Study Drug Treatment.|To evaluate the percentage of subjects who experience ≥50% reduction in osteoarthritis knee pain in the target knee compared with baseline after a 7 day period. Subjects in the once daily application group recorded their knee pain in a diary twice: at 12 hrs (± 1 hr) after their initial application and then again within ≤30 minutes before their daily topical application which was to be applied at 24 hrs (± 1 hr) after their previous day's application on all subsequent study days. Subjects in the twice daily application group recorded their knee pain in a diary within ≤30 minutes before each application on all study days. Subjects used a 100mm visual analogue scale when assessing their knee pain.|Study Days 1-7|The analysis population included all subjects who received at least one application of study drug and reported pain scores during Study Days 1-7.|||percentage of subjects|||Number
2537698|NCT03124407|Primary|Percentage of Subjects With 50% or Greater Pain Score Reduction From Baseline to 24 Hours After First Dose of Study Drug Treatment.|To evaluate the percentage of subjects who experience ≥50% reduction in osteoarthritis knee pain in the target knee compared with baseline at 24 hours following the first study drug treatment. Subjects in the once daily application group recorded their knee pain in a diary twice: at 12 hrs (± 1 hr) after their initial application and then again within ≤30 minutes before their daily topical application which was to be applied at 24 hrs (± 1 hr) after their previous day's application on all subsequent study days. Subjects in the twice daily application group recorded their knee pain in a diary within ≤30 minutes before each application on all study days. Subjects used a 100mm visual analogue scale when assessing their knee pain.|Study Day 2|The analysis population included all subjects who received at least one application of study drug and reported a pain score on Study Day 2.|||percentage of subjects|||Number
2537699|NCT03124381|Secondary|Overall Size of Inflammatory Lesions - Week 12|Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large|12 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a scale||Standard Deviation|Mean
2537700|NCT03124381|Secondary|Overall Size of Inflammatory Lesions - Week 8|Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large.|8 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a scale||Standard Deviation|Mean
2537701|NCT03124381|Secondary|Overall Size of Inflammatory Lesions - Week 4|Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large|4 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a scale||Standard Deviation|Mean
2537702|NCT03124381|Secondary|Overall Size of Inflammatory Lesions - Week 2|Additional investigator efficacy assessment. Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large|2 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a scale||Standard Deviation|Mean
2537703|NCT03124381|Secondary|Overall Size of Inflammatory Lesions - Week 1|Additional investigator efficacy assessment. 0-9 scale where 0 = no longer visible; 9 = overall size is very large|1 week|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a scale||Standard Deviation|Mean
2537704|NCT03124381|Secondary|Overall Redness of Inflammatory Lesions - Week 12|Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness|12 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a scale||Standard Deviation|Mean
2537705|NCT03124381|Secondary|Overall Redness of Inflammatory Lesions - Week 8|Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness|8 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a scale||Standard Deviation|Mean
2537706|NCT03124381|Secondary|Overall Redness of Inflammatory Lesions - Week 4|Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness|4 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a scale||Standard Deviation|Mean
2537707|NCT03124381|Secondary|Overall Redness of Inflammatory Lesions - Week 2|Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness|2 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a scale||Standard Deviation|Mean
2537708|NCT03124381|Secondary|Overall Redness of Inflammatory Lesions - Week 1|Additional investigator efficacy assessment. 0-9 scale where 0 = no redness associated with the inflammatory lesions; 9 = overall, inflammatory lesions exhibit severe degree of redness|1 week|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a scale||Standard Deviation|Mean
2537709|NCT03124381|Secondary|Investigator Global Acne Assessment - Week 12|Investigator Global Acne Assessment using Modified Cooke's Scale - Week 12. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.|12 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a scale||Standard Deviation|Mean
2537710|NCT03124381|Secondary|Investigator Global Acne Assessment - Week 8|Investigator Global Acne Assessment using Modified Cooke's Scale - Week 8. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.|8 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a scale||Standard Deviation|Mean
2537711|NCT03124381|Secondary|Investigator Global Acne Assessment - Week 4|Investigator Global Acne Assessment using Modified Cooke's Scale - Week 4. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.|4 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a scale||Standard Deviation|Mean
2537712|NCT03124381|Secondary|Investigator Global Acne Assessment - Week 2|Investigator Global Acne Assessment using Modified Cooke's Scale - Week 2. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.|2 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a scale||Standard Deviation|Mean
2537713|NCT03124381|Secondary|Investigator Global Acne Assessment - Week 1|Investigator Global Acne Assessment using Modified Cooke's Scale - Week 1. Modified Cooke's scale ranges from 0 = clear/no acne to 5 = very severe acne. Half-points are allowed.|1 week|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Units on a scale||Standard Deviation|Mean
2537714|NCT03124381|Secondary|Global Face Total Lesion Count - Week 12|Sum of inflammatory and non-inflammatory lesions|12 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Lesions||Standard Deviation|Mean
2537715|NCT03124381|Secondary|Global Face Total Lesion Count - Week 8|Sum of inflammatory and non-inflammatory lesions|8 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Lesions||Standard Deviation|Mean
2537716|NCT03124381|Secondary|Global Face Total Lesion Count - Week 4|Sum of inflammatory and non-inflammatory lesions|4 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Lesions||Standard Deviation|Mean
2537717|NCT03124381|Secondary|Global Face Total Lesion Count - Week 2|Sum of inflammatory and non-inflammatory lesions|2 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Lesions||Standard Deviation|Mean
2537718|NCT03124381|Secondary|Global Face Non-Inflammatory Lesion Count - Week 12|Sum of open comedones and closed comedones|12 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Non-inflammatory Lesions||Standard Deviation|Mean
2537719|NCT03124381|Secondary|Global Face Non-Inflammatory Lesion Count - Week 8|Sum of open comedones and closed comedones|8 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Non-inflammatory Lesions||Standard Deviation|Mean
2537720|NCT03124381|Secondary|Global Face Non-Inflammatory Lesion Count - Week 4|Sum of open comedones and closed comedones|4 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Non-inflammatory lesions||Standard Deviation|Mean
2537721|NCT03124381|Secondary|Global Face Non-Inflammatory Lesion Count - Week 2|Sum of open comedones and closed comedones|2 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Non-inflammatory Lesions||Standard Deviation|Mean
2537722|NCT03124381|Secondary|Global Face Inflammatory Lesion Count - Week 12|Papules and pustules counted together|12 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Inflammatory Lesions||Standard Deviation|Mean
2537723|NCT03124381|Secondary|Global Face Inflammatory Lesion Count - Week 8|Papules and pustules counted together|8 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Inflammatory Lesions||Standard Deviation|Mean
2537724|NCT03124381|Secondary|Global Face Inflammatory Lesion Count - Week 4|Papules and pustules counted together|4 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Inflammatory Lesions||Standard Deviation|Mean
2537725|NCT03124381|Secondary|Global Face Inflammatory Lesion Count - Week 2|Papules and pustules counted together|2 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Inflammatory Lesions||Standard Deviation|Mean
2537726|NCT03124381|Secondary|Global Face Closed Comedones Count - Week 12|Closed comedones count on global face - Week 12|12 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Closed Comedones||Standard Deviation|Mean
2537727|NCT03124381|Secondary|Global Face Closed Comedones Count - Week 8|Closed comedones count on global face - Week 8|8 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Closed Comedones||Standard Deviation|Mean
2537728|NCT03124381|Secondary|Global Face Closed Comedones Count - Week 4|Closed comedones count on global face - Week 4|4 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Closed Comedones||Standard Deviation|Mean
2537729|NCT03124381|Secondary|Global Face Closed Comedones Count - Week 2|Closed comedones count on global face - Week 2|2 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Closed Comedones||Standard Deviation|Mean
2537730|NCT03124381|Secondary|Global Face Open Comedones Count - Week 12|Open comedones count on global face - Week 12|12 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Open Comedones||Standard Deviation|Mean
2537731|NCT03124381|Secondary|Global Face Open Comedones Count - Week 8|Open comedones count on global face - Week 8|8 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Open Comedones||Standard Deviation|Mean
2537732|NCT03124381|Secondary|Global Face Open Comedones Count - Week 4|Open comedones count on global face - Week 4|4 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Open Comedones||Standard Deviation|Mean
2537733|NCT03124381|Secondary|Global Face Open Comedones Count - Week 2|Open comedones count on global face - Week 2|2 weeks|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Open Comedones||Standard Deviation|Mean
2537759|NCT03124108|Secondary|Change From Baseline in Plasminogen Activator Inhibitor-1 Antigen (AG) Levels at Endpoint|Change from baseline in plasminogen activator inhibitor-1 AG levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||microgram per liter (mcg/L)||Standard Deviation|Mean
2537734|NCT03124381|Secondary|Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 8 and Week 12|Global face total lesion counts are averaged across Week 8 and Week 12. Percent change from baseline to the mean is then calculated.|Baseline to Week 8 and Week 12|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Percent Change in Lesions||Standard Deviation|Mean
2537735|NCT03124381|Secondary|Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 4 and Week 8|Global face total lesion counts are averaged across Week 4 and Week 8. Percent change from baseline to the mean is then calculated.|Baseline to Week 4 and Week 8|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations|||Percent Change in Lesions||Standard Deviation|Mean
2537736|NCT03124381|Secondary|Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 2 and Week 4|Global face total lesion counts are averaged across Week 2 and Week 4. Percent change from baseline to the mean is then calculated.|Baseline to Week 2 and Week 4|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Percent Change in Lesions||Standard Deviation|Mean
2537737|NCT03124381|Secondary|Global Face Total Lesion Count - Percent Change From Baseline to the Mean of All Visits|Global face total lesion counts are averaged across all applicable post-baseline visits (Week 2, Week 4, Week 8, and Week 12). Percent change from baseline to the mean is then calculated.|Baseline to Week 2, Week 4, Week 8, and Week 12|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Percent Change in Lesions||Standard Deviation|Mean
2537738|NCT03124381|Secondary|Global Face Total Lesion Count - Percent Change - Baseline to Week 8|Percent change from baseline in global face total lesion count at Week 8|Baseline and Week 8|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Percent Change in Lesions||Standard Deviation|Mean
2537739|NCT03124381|Secondary|Global Face Total Lesion Count - Percent Change - Baseline to Week 4|Percent change from baseline in global face total lesion count at Week 4|Baseline and Week 4|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Percent Change in Lesions||Standard Deviation|Mean
2537740|NCT03124381|Secondary|Global Face Total Lesion Count - Percent Change - Baseline to Week 2|Percent change from baseline in global face total lesion count at Week 2|Baseline and Week 2|Intent-to-treat population was used, including all subjects with data for this time point. The number may be less than the total due to subject withdrawal prior to this time point or missed visits/evaluations.|||Percent Change in Lesions||Standard Deviation|Mean
2537741|NCT03124381|Primary|Global Face Total Lesion Count - Percent Change - Baseline to Week 12|Percent change from baseline in global face total lesion count at Week 12|Baseline and Week 12|Intent-to-treat population was used, including all subjects with data for this time point. Missing values were imputed by carrying forward the last observed post-baseline score. There was no post-baseline data to carry forward for three subjects.|||Percent Change in Lesions||Standard Deviation|Mean
2537742|NCT03124342|Secondary|Number of Same-hospital Outpatient Clinic Visits in the 30 Days After Hospital Discharge||Within 30 days of hospital discharge||||visits|||Number
2537743|NCT03124342|Secondary|Number Participants With Same-hospital Emergency Department Visits in the 30 Days After Hospital Discharge||Within 30 days of hospital discharge||||Participants|||Count of Participants
2537744|NCT03124342|Secondary|Number of Participants Death or Readmission in the 30 Days After Hospital Discharge|Composite outcome of death or readmission in the 30 days after hospital discharge|Within 30 days of hospital discharge||||Participants|||Count of Participants
2537745|NCT03124342|Secondary|Number of Participants With Same-hospital Readmission in the 30 Days After Hospital Discharge|Readmission to the study hospital in the 30 days after hospital discharge|Within 30 days of hospital discharge||||Participants|||Count of Participants
2537746|NCT03124342|Primary|Number of Components of the ICU Recovery Program Received|Number of components of the ICU Recovery Program intervention received by patients between ICU transfer and 30 days after hospital discharge. The 10-components considered part of the ICU Recovery Program include: (1) nurse practitioner in-person visit between ICU transfer and hospital discharge, (2) ICU Recovery Program pamphlet, (3) pharmacist medication reconciliation at the time of ICU transfer, (4) ICU Recovery Program contact line, (5) nurse practitioner history and physical in ICU Recovery Clinic, (6) pharmacist medication reconciliation in ICU Recovery Clinic, (7) cognitive/mental health assessment and psychoeducation in ICU Recovery Clinic, (8) case management consultation in ICU Recovery Clinic, (9) patient centered consultation with pulmonary and critical care medicine physician in ICU Recovery clinic, (10), directed subspecialty referrals.|From the time of study enrollment to 30 days after hospital discharge||||interventions||Inter-Quartile Range|Median
2537747|NCT03124199|Secondary|Compliance With Treatment of Patients That Completed the Study|Percentage of patients that has comply with treatment, considered as intake of more than 90% of study drugs in patients who attended the post-treatment visit.|1 month||||percentage of participants|||Number
2537748|NCT03124199|Secondary|Tolerability of Treatment|Patients with side effects present during treatment and in the 4 weeks after end of treatment|1 month||||participants|||Number
2537749|NCT03124199|Primary|Percentage of Participants With H.Pylori Infection Eradication|Percentage of Participants with H.Pylori Infection Eradication confirmed with urea breath test at least 4 weeks after the end of treatment|1 month||||percentage of participants||95% Confidence Interval|Number
2537760|NCT03124108|Secondary|Change From Baseline in Interleukin 6 Levels at Endpoint|Change from baseline in interleukin 6 levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||ng/L||Standard Deviation|Mean
2537750|NCT03124108|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical (investigational) product and which does not necessarily have to have a causal relationship with this treatment. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is another medically important condition. TEAEs is defined as (1) it is not present when active phase of study (time of first dose) begins and is not a chronic condition that is part of patient's medical history, or it is present at start of active phase or as part of patient's medical history, but severity/frequency increases during active phase.|Up to Week 12|The Safety Set included all randomized participants who were administered at least one dose of study medication.|||Participants|||Count of Participants
2537751|NCT03124108|Secondary|Change From Baseline in Primary Biliary Cholangitis -40 (PBC-40) Quality of Life (QoL) Questionnaire Scores|PBC-40 QoL Questionnaire is a patient-derived, disease-specific QoL measure developed and validated for use in PBC. It consists of 9 domains with total 40 questions as: 1) digestion and diet (questions 1-3, total score range: 3-15); 2) experiences (questions 4-7, total score range: 4-20); 3) itching (questions 8-10, total score range: 3-15); 4) fatigue (questions 11-18, total score range: 8-40); 5) effort and planning (questions 19-21, total score range: 3-15); 6) memory and concentration (questions 22-27, total score range: 6-30); 7) affects you as a person (questions 28-33, total score range: 6-30); 8) affects your social life (questions 34-37, total score range: 4-20); 9) overall impact on your life (questions 38-40, total score range: 3-15). PBC-40 QoL Questionnaire has 40 questions, each scored on scale of 1-5 (1 = least impact, 5 = greatest impact). For each domain, scoring involved summing individual question response scores. Higher scores indicate poorer quality of life.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||Units on a scale||Standard Deviation|Mean
2537752|NCT03124108|Secondary|Change From Baseline in Pruritus as Assessed by Visual Analogue Scale (VAS) Total Score|The VAS is a reliable and validated method of pruritus assessment. The VAS is adequate in assessing the severity of the symptom; it does not take into account other aspects of pruritus, such as the relative impact of pruritus on quality of life. The VAS, for pruritus assessment, requires the participant to use abstract thought processes to convert their itch severity to a mark on a continuum. A participant draws a line anywhere on the scale ranging from 0 to 10 (where 0 represents 'no itching' and 10 represents 'worst possible itching') that best represents the severity of participant's itching and the scoring involves manual measuring of the mark with a ruler on range of 0 to 100 millimeter (mm). Higher scores indicate worse itching.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2537753|NCT03124108|Secondary|Change From Baseline in 5D-Itch Scale Total Score|5 dimensional (5D)-Itch Scale is a reliable, multidimensional measure of itching that has been validated in participants with chronic pruritus to detect changes over time. It consists of 5 domains: duration, degree, direction, disability, and distribution. The duration, degree and direction domains each include one item, while the disability domain has four items (sleep, leisure/social, housework/errands, work/school). All items of the first four domains were measured on a 5-point Likert scale. The distribution domain included 16 potential locations of itch, including 15 body part items (head/scalp, soles, face, palms, chest, abdomen, back, buttocks, thighs, lower legs, tops of feet/toes, tops of hands/fingers, upper arms, groin, forearms) and one point of contact with clothing or bandages. Scores of each of five domains are achieved separately and then summed together to obtain a total 5-D score. 5-D scores can potentially range between 5 (no pruritus) and 25 (most severe pruritus).|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2537754|NCT03124108|Secondary|Change From Baseline in Fibrinogen Levels at Endpoint|Change from baseline in fibrinogen levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||g/L||Standard Deviation|Mean
2537755|NCT03124108|Secondary|Change From Baseline in Haptoglobin Levels at Endpoint|Change from baseline in haptoglobin levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||g/L||Standard Deviation|Mean
2537756|NCT03124108|Secondary|C-reactive Protein Level at Endpoint|C-reactive protein level at endpoint was reported.|Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||milligram per liter (mg/L)||95% Confidence Interval|Geometric Mean
2537757|NCT03124108|Secondary|Change From Baseline in Autotaxin Levels at Endpoint|Change from baseline in autotaxin levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||mcg/L||Standard Deviation|Mean
2537758|NCT03124108|Secondary|Change From Baseline in Cytokeratin-18 Levels at Endpoint|Change from baseline in cytokeratin-18 (M30 and M65) levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||picomole per liter (pmol/L)||Standard Deviation|Mean
2537935|NCT03118843|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2537761|NCT03124108|Secondary|Change From Baseline in Transforming Growth Factor Beta Levels at Endpoint|Change from baseline in transforming growth factor beta levels at endpoint was reported,|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||ng/L||Standard Deviation|Mean
2537762|NCT03124108|Secondary|Change From Baseline in Tumor Necrosis Factor Levels at Endpoint|Change from baseline in tumor necrosis factor levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||ng/L||Standard Deviation|Mean
2537763|NCT03124108|Secondary|Change From Baseline in Immunoglobulin M (IgM) Levels at Endpoint|Change from baseline in IgM levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||g/L||Standard Deviation|Mean
2537764|NCT03124108|Secondary|Change From Baseline in Fibroblast Growth Factor-19 Levels at Endpoint|Change from baseline in fibroblast growth factor-19 levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||nanogram per liter (ng/L)||Standard Deviation|Mean
2537765|NCT03124108|Secondary|Change From Baseline in 7 Alpha-hydroxy-4-cholesten-3-one Levels at Endpoint|Change from baseline in 7 alpha-hydroxy-4-cholesten-3-one levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||10^-9 mol/L||Standard Deviation|Mean
2537766|NCT03124108|Secondary|Change From Baseline in Total Bile Acid Levels at Endpoint|Change from baseline in total bile acid levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||10^-9 mol/L||Standard Deviation|Mean
2537767|NCT03124108|Secondary|Change From Baseline in Total Conjugated Bile Acid Levels at Endpoint|Change from baseline in total conjugated bile acid levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||10^-9 mol/L||Standard Deviation|Mean
2537768|NCT03124108|Secondary|Change From Baseline in Total Free Bile Acid Levels at Endpoint|Change from baseline in total free bile acid levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||10^-9 mole per liter (mol/L)||Standard Deviation|Mean
2537769|NCT03124108|Secondary|Change From Baseline in Triglycerides Levels at Endpoint|Change from baseline in triglycerides levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||mmol/L||Standard Deviation|Mean
2537770|NCT03124108|Secondary|Change From Baseline in High-density Lipoprotein (HDL) Cholesterol Levels at Endpoint|Change from baseline in HDL-cholesterol levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||mmol/L||Standard Deviation|Mean
2537771|NCT03124108|Secondary|Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol Levels at Endpoint|Change from baseline in LDL-cholesterol at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||mmol/L||Standard Deviation|Mean
2537772|NCT03124108|Secondary|Change From Baseline in Cholesterol Levels at Endpoint|Change from baseline in cholesterol levels at endpoints was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||millimole per liter (mmol/L)||Standard Deviation|Mean
2537773|NCT03124108|Secondary|Change From Baseline in Albumin Levels at Endpoint|Change from baseline in albumin levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||gram per liter (g/L)||Standard Deviation|Mean
2537774|NCT03124108|Secondary|Change From Baseline in Conjugated Bilirubin Levels at Endpoint|Change from baseline in conjugated bilirubin levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||mcmol/L||Standard Deviation|Mean
2537775|NCT03124108|Secondary|Change From Baseline in Total Bilirubin (BIL) Levels at Endpoint|Change from baseline in total BIL levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||micromole per liter (mcmol/L)||Standard Deviation|Mean
2537776|NCT03124108|Secondary|Change From Baseline in 5 Prime (') Nucleotidase Levels at Endpoint|Change from baseline in 5' nucleotidase levels at endpoint was reported. 5' nucleotidase is an enzyme used as a biomarker of hepatobiliary cholestasis and is less sensitive but more specific than GGT and ALP.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||U/L||Standard Deviation|Mean
2537936|NCT03118843|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to Week 12|Participants in the Safety Analysis Set were analyzed.|||percentage of participants|||Number
2537777|NCT03124108|Secondary|Change From Baseline in Gamma-glutamyl Transferase (GGT) Levels at Endpoint|Change from baseline in GGT levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||U/L||Standard Deviation|Mean
2537778|NCT03124108|Secondary|Change From Baseline in Aspartate Aminotransferase (AST) Levels at Endpoint|Change from baseline in AST levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||U/L||Standard Deviation|Mean
2537779|NCT03124108|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) Levels at Endpoint|Change from baseline in ALT levels at endpoint was reported.|Baseline, Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||U/L||Standard Deviation|Mean
2537780|NCT03124108|Secondary|Percentage of Participants With Response Defined by Normalized Albumin (ALB) Levels at Endpoint|The response was defined by normalized ALB levels (3.5-5.2 gram per deciliter [g/dL] for ages 18-60 years; 3.2-4.6 g/dL for ages 61-91 years) at endpoint.|At Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||Percentage of participants|||Number
2537781|NCT03124108|Secondary|Percentage of Participants With Response Defined by Normalized Bilirubin (BIL) at Endpoint|The response was defined by normalized BIL levels (BIL ULN <1.20 milligram per deciliter [mg/dL]) at endpoint.|At Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||Percentage of participants|||Number
2537782|NCT03124108|Secondary|Percentage of Participants With Response Defined by Normalized Alkaline Phosphatase Levels at Endpoint|The response was defined by normalized ALP levels (ALP ULN 105 units per liter [U/L] for females, 129 U/L for males) at endpoint.|At Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||Percentage of participants|||Number
2537783|NCT03124108|Secondary|Percentage of Participants With Response Defined by 10, 20 and 40 Percent Reduction in Alkaline Phosphatase|Percentage of participants with response (defined by at least 10%, 20%, and 40% decrease in ALP from baseline to Endpoint) reported.|At Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||Percentage of participants|||Number
2537784|NCT03124108|Secondary|Median Percentage Risk as Assessed by United Kingdom-Primary Biliary Cholangitis (UK-PBC) Risk Total Score at Endpoint|UK-PBC risk score at endpoint estimated that the median percentage risk that a participant treated with ursodeoxycholic acid (UDCA) will develop liver failure requiring liver transplant in 5, 10 and 15 years. UK-PBC score was calculated at each of the 3 survivor functions 1-baseline survival function^exp(0.0287854*[alpEPxuln-1.722136304] - 0.0422873*[{(altastEPxuln/10)^-1} - 8.675729006] + 1.4199 * [ln{bilEPxuln /10}+2.709607778] -1.960303*[albxlln -1.17673001]-0.4161954*[ pltxlln -1.873564875]). Where: Baseline survivor function=0. 982 (at 5 years); 0. 941 (at 10 years); 0.893 (at 15 years). alpEPxuln = ALP at endpoint/upper level normal ALP; altastEPxuln=(ALT, AST) at endpoint/upper level normal of the value; bilEPxuln=bilirubin at endpoint/upper level normal bilirubin; albxlln=albumin at baseline/albumin lower level normal; pltxlln=platelet count at baseline/ platelet count lower level normal.|At Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||Percentage risk||Full Range|Median
2537785|NCT03124108|Secondary|Percentage of Participants With Response Based on Toronto II Risk Score at Endpoint|Percentage of participants with response based on Toronto II risk scores was defined as ALP <= 1.75 * ULN.|At Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||Percentage of participants|||Number
2537786|NCT03124108|Secondary|Percentage of Participants With Response Based on Toronto I Risk Score at Endpoint|Percentage of participants with response based on Toronto I risk score was defined as ALP <= 1.67 *ULN.|At Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||Percentage of participants|||Number
2537787|NCT03124108|Secondary|Percentage of Participants With Response Based on PARIS II Risk Score at Endpoint|Percentage of participants with response based on Paris II risk score was defined as ALP <= 1.5 * ULN and AST <= 1.5 * ULN and bilirubin within normal limits.|At Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||Percentage of participants|||Number
2537788|NCT03124108|Secondary|Percentage of Participants With Response Based on PARIS I Risk Score at Endpoint|Percentage of participants with response based on Paris I risk score was defined as ALP less than or equal to (<=) 3 * ULN and aspartate aminotransferase (AST) <= 2 * ULN and bilirubin within normal limits.|At Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||Percentage of participants|||Number
2537789|NCT03124108|Secondary|Percentage of Participants With Response Defined by Composite Risk Scores (ALP < 2 * Upper Limit of Normal at Endpoint, Total Bilirubin Within Normal Limits at Endpoint, and > 40% ALP Reduction From Baseline to Endpoint)|Percentage of participants with response defined by composite risk scores (ALP < 2 * ULN at endpoint, Total BIL within normal limits at endpoint, and > 40% ALP reduction from baseline to endpoint) was reported.|Up to Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||Percentage of participants|||Number
2537790|NCT03124108|Secondary|Percentage of Participants With Response Defined by Composite Risk Scores (ALP< 1.67 * Upper Limit of Normal [ULN] at Endpoint, Total Bilirubin [BIL] Within Normal Limits at Endpoint, and Greater Than [>] 15% ALP Reduction From Baseline to Endpoint)|Percentage of participants with response defined by Composite Risk Scores (ALP Less than [<] 1.67 * ULN at endpoint, Total BIL within normal limits at endpoint, and > 15% ALP reduction from baseline to Endpoint) was reported.|Up to Week 12 (Endpoint)|The mITT analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||Percentage of participants|||Number
2537791|NCT03124108|Primary|Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) Levels at Week 12 (Endpoint)|Relative change from baseline is in serum ALP levels at Week 12 (endpoint) were reported. Relative change from baseline is defined as percentage (%) change from baseline to endpoint.|Baseline, Week 12 (Endpoint)|The modified Intent-to-Treat (mITT) analysis set included all randomized participants who received at least one study drug dose with available baseline value and at least one post baseline value for the primary endpoint.|||Percent change||Standard Deviation|Mean
2537792|NCT03123874|Primary|Total Live Aerobic Bacterial Counts|Number of live total aerobic bacteria in milk assessed by aerobic culturing of milk on plate count agar. Reported as colony-forming units (CFU)/mL.|0 days after pumping|Data for all participants analyzed.|||Colony-forming units (CFU)/mL||Standard Deviation|Geometric Mean
2537793|NCT03123874|Primary|Bacterial Community Diversity|Bacterial community diversity will be assessed using the the Shannon diversity index. The Shannon diversity index is a type of entropy measure and is a function of the distribution of the total number of organisms across all of the species. If S is the total number of species in the sample and p_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = −Σ p_i log(p_i). This metric will be assessed on data collected via high-throughput sequencing of the bacterial 16S rRNA gene present in milk.|0 days after pumping|Data analyzed from all participants.|||Shannon Diversity Index||Standard Deviation|Mean
2537794|NCT03123874|Primary|Bacterial Community Richness|Richness is the total number of different bacterial taxa detected in the sample. This metric will be assessed on data collected via high-throughput sequencing of the bacterial 16S rRNA gene present in milk.|0 days after pumping|Data analyzed for all participants|||Observed taxa||Standard Deviation|Mean
2537795|NCT03123848|Secondary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.|Up to approximately 1 month|Safety analysis set included all participants who received the study drug. AEs for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately as per planned analysis.|||Participants|||Number
2537796|NCT03123848|Primary|Apparent Total Body Clearance of Drug at the Terminal Phase After Extravascular Administration (CL/F)|CL/F is the apparent total body clearance of drug at the terminal phase after extravascular administration.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose|PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. CL/F for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis.|||milliliter per hour (mL/h)||Standard Deviation|Mean
2537797|NCT03123848|Primary|Apparent Volume of Distribution (Vz/F)|Vz/F is defined as the apparent volume of distribution at the terminal phase after extravascular administration.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose|PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. Vz/F for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis.|||milliliter (mL)||Standard Deviation|Mean
2537798|NCT03123848|Primary|Terminal Elimination Half-Life (t1/2)|t1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose|PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. t1/2 for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis.|||Hour||Standard Deviation|Mean
2537799|NCT03123848|Primary|Elimination Rate Constant (Lambda[z])|Lambda(z) is first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose|PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. Lambda[z] for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis.|||per hour (1/h)||Standard Deviation|Mean
2537800|NCT03123848|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC0-infinity)|AUC(0-infinity) is defined as area under the plasma concentration-time curve from time zero to infinite time.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose|PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. AUC0-inf for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis.|||h*ng/mL||Standard Deviation|Mean
2537801|NCT03123848|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time the Last Quantifiable Time (AUC[0-last])|AUC(0-last) is defined as area under the plasma concentration-time curve from time zero to time the last quantifiable time, calculated by linear trapezoidal summation.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose|PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration time zero to time the last quantifiable time. AUC[0-last] for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis.|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
2537802|NCT03123848|Primary|Time to Reach the Maximum Plasma Concentration (Tmax)|Tmax is defined as the time to reach the maximum plasma concentration.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose|PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. Tmax for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis.|||hour (h)||Full Range|Median
2537803|NCT03123848|Primary|Concentration at Last Quantifiable Time Point (Clast)|Clast is defined as concentration at last quantifiable time point.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose|PK analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. Clast for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis.|||ng/mL||Standard Deviation|Mean
2537804|NCT03123848|Primary|Maximum Observed Plasma Concentration (Cmax)|The Cmax is the maximum observed plasma concentration.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 20, 24, 36, 48, 60, 72 hours postdose|Pharmacokinetic (PK) analysis set included all participants who received the study drug and had at least one plasma concentration data-point after administration. Cmax for each analyte (Darunavir and Cobicistat) of fixed dose combination has been reported separately in each arm as per planned analysis.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2537805|NCT03123471|Secondary|Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Exposure Period|The apremilast-exposure period started on the date of the first dose of apremilast (Week 0 for participants originally randomized to apremilast or Week 16 for participants originally randomized to placebo) to the last dose of apremilast. A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort.|Week 0 to 32;|The apremilast participants as treated population, which includes all participants who were randomized to (at Week 0) or treated with (at Week 16) apremilast 30 mg BID, and received at least one dose of apremilast after randomization or Week 16.|||Participants|||Count of Participants
2537806|NCT03123471|Secondary|Number of Participants With Treatment Emergent Adverse Events During the Apremilast-Extension Phase|A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort.|Weeks 16 to Week 32; the mean treatment duration was 14.6 weeks and 15.3 weeks in the APR 30/APR 30 BID and placebo/APR 30 BID arms, respectively|Safety population includes participants who received at least 1 dose of study drug. Participants who entered into the apremilast extension phase and were treated.|||Participants|||Count of Participants
2537807|NCT03123471|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase|A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = could be non-serious or serious) = symptoms causing severe pain discomfort.|Week 0 to Week 16; mean duration of exposure was 14.5 weeks and 14.6 weeks for participants randomized to placebo and apremilast respectively.|Safety population includes participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2537808|NCT03123471|Secondary|Change From Baseline in Dermatological Life Quality Index (DLQI) Total Score at Week 16|"DLQI is questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if No, then the subject is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being A lot, A little, or Not at all (scores 2, 1, or 0 respectively). The DLQI total score was derived by summing all item scores, and has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best."|Baseline to Week 16|The intent to treat population included participants who were randomized. Missing values were imputed using the multiple imputation method.|||Units on a Scale||Standard Error|Least Squares Mean
2537809|NCT03123471|Secondary|Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch NRS Score by Visit in the Placebo-Controlled Phase|"The scalp itch NRS is a 11-point scale to assess scalp itch. The scale ranges from 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch."|Baseline to Weeks 2, 4, 8 and 12|The intent to treat population included participants who were randomized; analysis includes participants with a baseline scalp itch NRS Score ≥4. Missing values were imputed using the multiple imputation method.|||Percentage of Participants||95% Confidence Interval|Number
2538412|NCT03100058|Secondary|Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol)|Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48|Baseline to Week 24, Week 24 to Week 48 (Epoch 4)|Full Analysis Set|||mmol/L||95% Confidence Interval|Mean
2537810|NCT03123471|Secondary|Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch NRS Score by Visit in the Placebo-Controlled Phase|"The Whole Body Itch NRS scale is a 11-point scale to assess whole body itch. The scale ranges from 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity."|Baseline to Weeks 2, 4, 6, 8 and 12|Participants in the ITT population with a baseline whole body itch NRS Score ≥ 4. Missing values were imputed using the multiple imputation method.|||Percentage of Participants||95% Confidence Interval|Number
2537811|NCT03123471|Secondary|Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Scalp Itch Numeric Rating Score (NRS) at Week 16|"The scalp itch NRS is a 11-point scale to assess scalp itch. The scale ranges from 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch."|Baseline to Week 16|Includes participants in the ITT population had baseline scalp itch NRS Score ≥ 4. Missing values were imputed using the multiple imputation method.|||Percentage of Participants||95% Confidence Interval|Number
2537812|NCT03123471|Secondary|Percentage of Participants With ≥ 4-Point Reduction (Improvement) From Baseline in the Whole Body Itch Numeric Rating Score at Week 16|"The Whole Body Itch NRS scale is an 11-point scale to assess whole body itch. The scale ranges from 0-10, where 0 represents no itch, and 10 represents the worst imaginable itch, and a 4-point change from baseline was shown to be optimal for demonstrating a level of clinically meaningful improvement in itch severity. NRS response was defined as a ≥ 4-point reduction (improvement) from baseline."|Baseline to Week 16|Participants in the ITT population who had a baseline Body Itch NRS Score ≥4. Missing values were imputed using the multiple imputation method.|||Percentage of Participants||95% Confidence Interval|Number
2537813|NCT03123471|Primary|Percentage of Participants With Scalp Physician Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) With at Least a 2-Point Reduction From Baseline|The ScPGA is a measurement of overall scalp involvement by the investigator at the time of evaluation. The ScPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the 3 primary signs of the disease: erythema, scaling, and plaque elevation. When making the assessment of overall scalp severity, the investigator factored in areas that had already been cleared (ie, had scores of 0), not limited to the evaluation of remaining lesions for severity; consequently, the severity of each sign was averaged across all areas of involvement, including cleared lesions.|Baseline to Week 16|The intent to treat (ITT) population included participants who were randomized. Missing values were imputed using the multiple imputation (MI) method.|||Percentage of Participants||95% Confidence Interval|Number
2537814|NCT03123354|Primary|Accuracy of Sensor by Arms Calculation of Percent rSO2|The continuous measurements of regional oxygen saturation (rSO2) was compared against its reference cerebral oxygen saturation which is measured by a combination of arterial and jugular venous blood oxygen saturation. Absolute accuracy was determined by the root-mean-squared error (Arms). The Arms error value is calculated as the square root of the sum of the squares of mean bias and estimated standard deviation of bias. The bias is defined as the difference of the rSO2 and its blood reference.|One visit; up to 4 hours||||%rSO2|||Number
2537815|NCT03123263|Secondary|Number of Participants Hospitalized for Cardiac Issues.|any hospitalization for cardiac issues|1 year|patients receiving transtuzumab|||Participants|||Count of Participants
2537816|NCT03123263|Primary|LVEF|LV ejection fraction|Baseline (prior to therapy), at 3-6 months (mid-therapy), and at 1 year (end of therapy)||||percentage of blood in left ventricle||Standard Deviation|Mean
2537817|NCT03123055|Other Pre-specified|Immunogenicity of B-701 (Vofatamab)|Determine the immunogenicity of B-701 as measured by anti-B-701 antibody titers at several time points throughout the study.|2 years|||||||
2537818|NCT03123055|Other Pre-specified|PK Analysis of B-701 (Vofatamab)|PK will be analyzed by measuring B-701 C(trough) levels. B-701 C(trough) levels then will be summarized over time throughout the study and will be compared to predicted B-701 C(trough) levels, whose prediction is based on data observed in previous studies with B-701.|2 years|||||||
2537819|NCT03123055|Secondary|Change in Subject Reported Quality of Life|Evaluate the efficacy of B-701 (vofatamab) in combination with pembrolizumab in the treatment of subjects with UCC as measured by the change over time in subject reported quality of life as measured by the European Organization for Research and Treatment Quality of Life Questionnaire (EORTC QLQ-C30).|2 years|The study was terminated early and this outcome was not analyzed because the data were not collected.||||||
2537820|NCT03123055|Secondary|Efficacy of B-701 (Vofatamab) in Combination With Pembrolizumab as Measured by OS|Evaluate the efficacy of B-701 (vofatamab) in combination with pembrolizumab in the treatment of subjects with UCC as measured by overall survival (OS), defined as the time from first study drug administration to death from any cause (RECIST 1.1)|2.5 years|The study was terminated early and this outcome was not analyzed because the data were not collected.||||||
2537821|NCT03123055|Secondary|Efficacy of B-701 (Vofatamab) in Combination With Pembrolizumab as Measured by PFS|Evaluate the efficacy of B-701 (vofatamab) in combination with pembrolizumab in the treatment of subjects with UCC as measured by progression-free survival (PFS), defined as the time from a first study treatment dose to first occurrence of disease progression (per RECIST 1.1) or death from any cause, whichever occurs first.|2 years|The study was terminated early and this outcome was not analyzed because the data were not collected.||||||
2537822|NCT03123055|Secondary|Efficacy of B-701 (Vofatamab) in Combination With Pembrolizumab as Measured by DCR|Evaluate the efficacy of B-701 in combination with pembrolizumab in the treatment of subjects with UCC as measured by disease control rate (DCR), defined as the percentage of subjects who achieve either complete response (CR) or partial response (PR) or stable disease (SD) according to RECIST 1.1.|2 years|The study was terminated early and this outcome was not analyzed because the data were not collected.||||||
2537823|NCT03123055|Secondary|Efficacy of B-701 (Vofatamab) in Combination With Pembrolizumab as Measured by DOR|Evaluate the efficacy of B-701 (vofatamab) in combination with pembrolizumab in the treatment of subjects with UCC as measured by duration of objective response (DOR), defined as the time from first occurrence of a documented, objective response until the time of relapse or death from any cause (RECIST 1.1).|2 years|The study was terminated early and this outcome was not analyzed because the data were not collected.||||||
2537824|NCT03123055|Secondary|Assessment of Changes in Biomarkers Induced by B-701 (Vofatamab)|"Whole blood (PBMCs), serum, and plasma samples for biomarker analyses will be obtained prior to infusion of B-701 at pre-defined visit days.~The effects of B-701 on the downstream signaling of the FGFR3 pathway, tumor sub-type and on the immune surveillance of UCC tumors will be monitored using techniques that include gene expression profiling (such as whole transcriptome RNAseq), sequencing of T-cell receptors, and immunohistochemistry."|2.5 years|The study was terminated early and this outcome was not analyzed because the data were not collected.||||||
2537825|NCT03123055|Primary|Efficacy of B-701 (Vofatamab) Plus Pembrolizumab Measured by ORR|Evaluate the efficacy of B-701 (vofatamab) plus pembrolizumab in subjects with UCC as measured by objective response rate (ORR) by RECIST 1.1. ORR is defined as the percentage of subjects who have baseline measurable disease and who achieve a best response of either complete response (CR) or partial response (PR).|2 years||||Participants|||Count of Participants
2537826|NCT03123055|Primary|Number of Subjects Experiencing Adverse Events (AEs and SAEs)|Evaluate the safety and tolerability of B-701 (vofatamab) plus pembrolizumab in subjects with UCC as assessed by number of subjects experiencing adverse events (AEs and SAEs), physical examination findings, laboratory test results, and vital signs over time. This outcome is measured by a safety monitoring committee who regularly met and reviewed aggregate trends of reports AEs, lab ranges, physical exams etc. and determined if the drug was safe to continue.|2.5 years||||Participants|||Count of Participants
2537827|NCT03123055|Primary|Number of Participants With Dose Limiting Toxicities Within a Period of 35 Days|Number of Participants with Dose Limiting Toxicities within a period of 35 days will be analyzed reviewing the aggregate of adverse events (AEs) and serious adverse events (SAEs) by the B-701 program Safety Oversight Committee and will result in a recommended Phase 2 dose. Six subjects at a time are enrolled and observed for 35 days after the initial dose. If 2 or more subjects experience a DLT that dose will be declared intolerable and de-escalation of the dose will occur.|1 year||||Participants|||Count of Participants
2537828|NCT03122587|Primary|Change in Inhibitory Control (Mean D-prime on the Go/No-Go)|During the computerized Go/No-Go task, participants view a serial stream of pictures and are instructed to continuously press a button on the computer keyboard, but inhibit responses when stimuli are presented consecutively. Inhibitory control will be calculated as d-prime [z(hit rate) - z(false alarm rate)]. Each z-score of 0 is equal to the mean of the reference population, with a standard deviation of 1. Positive d-prime values indicate more inhibitory control, and negative values indicate less inhibitory control.|From Session 1 to Session 2, up to 6 days|3 participants did not have data due to impedance issues, behavioral noncompliance, and technology error|||z-score||Standard Deviation|Mean
2537829|NCT03122587|Primary|Change in Distress Tolerance (Mean Latency to Quit the PASAT-C)|The Computerized Paced Auditory Serial Addition Task (PASAT-C) is a psychological distress-inducing task. Numbers are presented sequentially on a computer screen and participants are asked to add the currently presented number to the previously presented number before the next number is presented. Participants select the answer using a computer mouse on a number pad displayed on the computer screen below the presented numbers. The speed of the number presentations is individually titrated in order to account for some individual differences in cognitive capacity, but not to secure equal performance among individuals. Incorrect or delayed responses are met with an aversive explosion sound. Distress tolerance is the latency to task termination (i.e., time until quit in minutes).|From Session 1 to Session 2, up to 6 days|3 participants did not have data due to impedance issues, behavioral noncompliance, and technology error|||minutes||Standard Deviation|Mean
2537830|NCT03122548|Secondary|Overall Survival (OS)|Number of weeks from the date of first dose of study treatment to the date of death from any cause, estimated using KM methods with 95% CIs for subjects in the SAF. Subjects without documentation of death at the time of analysis were censored as of the date the subject was last known to be alive, or the data cut-off date, whichever is earlier.|OS was assessed from the first dose of study treatment until death or study termination, whichever is earlier, assessed up to 15 weeks.|Analysis of OS was performed on subjects in the SAF.|||weeks||95% Confidence Interval|Median
2537831|NCT03122548|Secondary|Duration of Response (DOR)|Number of weeks from the first date a study subject achieved an objective disease response of CR or PR according to RECIST v1.1 to the date a study subject exhibited PD or death due to any cause, estimated using KM methods with 95% CIs. Subjects who do not experience PD or death at the time of analysis will be censored at the time of last evaluable tumor assessment or data cut-off date, whichever is earlier.|DOR assessed from the date of a post-baseline tumor assessment of CR or PR per RECIST v1.1 until the date of documented disease progression, starting of a new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.|No study subjects achieved CR or PR designation, therefore, per the final SAP DOR was not derived.|||Participants|||Count of Participants
2537832|NCT03122548|Secondary|Progression-Free Survival (PFS)|Number of weeks from the date of first dose of study treatment to the first date of objectively determined progressive disease (PD) according to RECIST v1.1 or death from any cause, estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). Subjects who do not experience PD and are alive on or before the data cut-off date will be censored at the time of last evaluable tumor assessment or data cut-off date, whichever is earlier.|Subjects followed for disease progression from first dose of study treatment until documented disease progression, initiation of new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.|Analysis of PFS was performed on subjects in the SAF.|||weeks||95% Confidence Interval|Median
2537833|NCT03122548|Secondary|Disease Control Rate (DCR)|The percentage of evaluable subjects who exhibited a post-baseline tumor assessment BOR rating of CR, PR, or SD per RECIST v1.1.|BOR was assessed from the first post-baseline tumor assessment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.||||Participants|||Count of Participants
2537844|NCT03122184|Secondary|Change in State Optimism|Measured by the State Optimism Scale developed by our team (SOM), which aims to capture the changeable nature of optimism based on time and situation. Minimum:7, Maximum:35. The higher number indicates a greater level of optimism. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.|Change of score from Baseline to 12 weeks, 24 weeks|Not all participants provided data at all follow-up points.|||score on a scale||Standard Deviation|Mean
2537834|NCT03122548|Primary|Objective Response Rate (ORR)|ORR was evaluated based upon the best overall response (BOR) for individual study subjects. BOR was determined by the highest post-baseline qualitative response value for each evaluable subject as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and given the following hierarchy of overall response results: complete response (CR) > partial response (PR) > stable disease (SD) > progressive disease (PD) > not evaluable (NE). The protocol-specified ORR was defined as the percentage of evaluable subjects with a BOR of CR or PR; however, this percentage was not calculated per the final study Statistical Analysis Plan (SAP). Therefore, the number of evaluable subjects with BOR RECIST v1.1 values of CR, PR, SD, PD, and NE are provided for this outcome measure. .|BOR was assessed from the first post-baseline tumor assessment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever is earlier, assessed up to 15 weeks.|Analysis based upon subjects who received at least 1 dose of CRS-207 and had at least 1 evaluable post-baseline RECIST v1.1 tumor response assessment or were discontinued due to toxicity (the Evaluable Analysis Set [EAS]). 2 subjects did not have post-baseline tumor response assessments and could not be evaluated for this outcome measure.|||Participants|||Count of Participants
2537835|NCT03122184|Secondary|Change in Perceived Stress|Measured by the Perceived Stress Scale (PSS-4) measure. Minimum: 0, Maximum: 16. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks Higher scores indicate greater levels of stress.|Change of score from Baseline to 12 week, 24 week|Not all participants provided data at all follow-up points.|||score on a scale||Standard Deviation|Mean
2537836|NCT03122184|Secondary|Change in Physical Activity|Measured by the self-report International Physical Activity Questionnaire (IPAQ). The measure asseses the types of intensity of physical activity that people do as part of their daily lives. All activities are converted to multiples of resting energy expenditure (MET) minutes per week. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.|Change of score from Baseline to 12 week, 24 week|Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.|||MET-minutes per week||Standard Deviation|Mean
2537837|NCT03122184|Secondary|Change in Cardiac Symptoms|Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study (WISE) to assess the presence and intensity of ten cardiac symptoms felt to best capture the range of symptoms experienced by ACS patients. Minimum: 0, Maximum: 30. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate greater levels of cardiac symptoms.|Change of score from Baseline to 12 week, 24 week|Not all participants provided data at all follow-up points.|||score on a scale||Standard Deviation|Mean
2537838|NCT03122184|Secondary|Change in Adherence to Health Behaviors|Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score. (Range: 3-18) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate better adherence to health behaviors.|Change of score from Baseline to 12 week, 24 week|Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.|||score on a scale||Standard Deviation|Mean
2537839|NCT03122184|Secondary|Change in SF-12 Scores (Mental)|The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past. (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher level of health related QoL.|Change of score from baseline to 12 and 24 weeks.|Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.|||score on a scale||Standard Deviation|Mean
2537840|NCT03122184|Secondary|Change in SF-12 Scores (Physical)|The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past. (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher level of health related QoL.|Change of score from Baseline to 12 week, 24 week|Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.|||score on a scale||Standard Deviation|Mean
2537841|NCT03122184|Secondary|Change in Physical Function|Measured by the Duke Activity Status Index (DASI), a 12-item questionnaire that inquires about activities of daily living, basic physical activity, and more strenuous physical function to gauge overall functional capacity. Minimum: 0, Maximum: 58.2. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate greater levels of functional capacity.|Change of score from Baseline to 12 week, 24 week|Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.|||score on a scale||Standard Error|Mean
2537842|NCT03122184|Secondary|Change in HADS-D Scores|The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.(Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate worse outcome (i.e. greater levels of depression).|Change in score from Baseline to 12 week, 24 week|We will use a random effects regression model with a random intercept for each participant.|||score on a scale||Standard Deviation|Mean
2537843|NCT03122184|Secondary|Changes in HADS-A Scores|The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients. (Range: 0-21) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of anxiety.|Change in score from Baseline to 12 week, 24 week|Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.|||score on a scale||Standard Deviation|Mean
2537937|NCT03118843|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set included all enrolled participants who took at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2537845|NCT03122184|Secondary|Change in Trait Optimism|Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism. (Range: 0-24) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of optimism.|Change in score from baseline to 12 week, 24 week|Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.|||score on a scale||Standard Deviation|Mean
2537846|NCT03122184|Secondary|Change in Positive Affect|The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect. (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of positive affect.|Change in score from Baseline to 12 weeks, 24 weeks|Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.|||score on a scale||Standard Deviation|Mean
2537847|NCT03122184|Secondary|Change in Dietary Adherence|Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat. Minimum= 0; Maximum= 216. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate lower levels of dietary adherence.|Change in score from Baseline to 12 weeks, 24 weeks|Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone who provided data at both time points.|||score on a scale||Standard Deviation|Mean
2537848|NCT03122184|Secondary|Change in Medication Adherence|Measured by Self-Reported Medication Adherence (SRMA), a two-item self-report medication adherence scale measuring percentage of time (in 10% increments) patients report taking their heart medications in the past one and two weeks. Minimum: 0, Maximum:100. Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher score indicates greater levels of medication adherence.|Change in score from Baseline to 12 weeks, 24 weeks|Number of participants analyzed in Week 12 differs from that analyzed at Week 24 because not everyone provided data at both time points.|||percentage||Standard Deviation|Mean
2537849|NCT03122184|Secondary|Minutes of Moderate to Vigorous Physical Activity (Actigraph)|ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at 12 weeks, and another week at 24 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity. In our analysis, data on pre-ACS activity was collected using the International Physical Activity Questionnaire (IPAQ) to control for baseline activity.|MVPA at 12 weeks and 24 weeks|Not everyone provided follow-up data at both time points.|||minutes/day||Standard Deviation|Mean
2537850|NCT03122184|Primary|Acceptability of the PP-MI Exercises: Ease Score|Participants will provide ratings of ease after each exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises.|Weeks 1-12||||units on a scale||Standard Deviation|Mean
2537851|NCT03122184|Primary|Acceptability of the PP-MI Exercises: Utility Score|Participants will provide ratings of utility after each exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises.|Weeks 1-12||||units on a scale||Standard Deviation|Mean
2537852|NCT03122184|Primary|Feasibility of the PP-MI Based Health Behavior Intervention|Feasibility will be measured by examining the number of completed exercises.|24 weeks||||exercises completed||Standard Deviation|Mean
2537853|NCT03122145|Primary|Laryngeal Vestibule Closure Reaction Time (LVCrt)|LVC temporal measures will be used to calculate the laryngeal vestibule closure reaction time (LVCrt)|Single Visit||||Milliseconds||Standard Deviation|Mean
2537854|NCT03122145|Secondary|Voluntary Peak Cough Flow Testing (With Electronic Peak Cough Flow Meter Device)|Voluntary peak cough flow testing will be used to capture the volume of air expelled in the 1st second of cough as measured in PEF and FEV1.|Baseline|Participants who completed the voluntary cough testing protocol in its entirety were included in the analysis|||liters per second||Standard Deviation|Mean
2537855|NCT03122145|Primary|Duration of Laryngeal Vestibule Closure (dLVC)|LVC temporal measures will be used to calculate the duration of laryngeal vestibule closure (dLVC)|Single Visit||||Milliseconds||Standard Deviation|Mean
2537856|NCT03122145|Primary|Reflexive Cough Testing (With Urge-to-Cough)|Reflexive cough testing will use a capsaicin challenge that will assess individual's cough motor and cough sensory thresholds. A modified Borg scale ranging from 0 (no cough) to 10 (maximal urge to cough) will be used to quantify these thresholds. A cough sensory threshold will be defined as a concentration of capsaicin eliciting a perceived urge to cough of 1 (very slight) >2/3 trials. A cough motor threshold will be the lowest concentration of capsaicin eliciting >2 cough responses in 2/3 trials.|Single assessment time period|Participants who completed the entire randomized reflex cough testing protocol were included in the analysis|||units on a scale||Full Range|Median
2537857|NCT03121950|Other Pre-specified|Change in Score on the Caregiver Burden Scale|A questionnaire asking caregivers about the impact of caregiving on daily life. Scores range from 0-88, with higher scores indicating worse outcomes or more burden. Scores of 0-20 = little or no burden, 21-40 = mild to moderate burden, 41-60 = moderate to severe burden, and 61-80 = severe burden.|12 weeks||||change in score on a scale||Standard Deviation|Mean
2537858|NCT03121950|Secondary|Change in Score on the Montreal Cognitive Assessment|The Montreal Cognitive Assessment (MoCA) is an assessment of overall cognitive status. The range of scores is 0-30, with higher scores indicating better outcomes. Scores 26 or higher indicates normal cognitive function.|12 weeks||||change in score on a scale||Standard Deviation|Mean
2537859|NCT03121950|Primary|Timed up and go Cognitive|The change in time to complete the Timed Up and Go - Cognitive (TUG-Cog) is recorded in seconds. The participant is timed with a stop watch while walking 3 meters turning and returning to a chair while performing a concurrent cognitive task. This time is compared to the Timed Up and Go (TUG) and the difference in time indicates the effect cognitive deficits have on motor function. Higher scores, indicating more time, means worse outcomes.|12 weeks||||units on a scale||Standard Deviation|Mean
2537965|NCT03118739|Other Pre-specified|Baseline MRI Variables - Systolic Circumferential Strain Rate||Baseline|Total number differs from Study totals due to subject non compliance with MRI (exam not completed)|||s^-1||Standard Deviation|Mean
2537860|NCT03121820|Primary|Pharmacokinetics of Memantinol by Assessment of Observed Maximum Plasma Concentration (Cmax)|"Comparison of the pharmacokinetic profile in terms of observed maximum plasma concentration, taken directly from the individual concentration-time curve, Cmax, of memantinol sourced in Memantinol® (JSC GEROPHARM, Russia) and Akatinol Memantine® (Merz Pharma GmbH & Co. KGaA, Germany)"|0 hours (pre-dose), as well as at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2537861|NCT03121820|Primary|Pharmacokinetics of Memantinol by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))|"Comparison of the pharmacokinetic profile in terms of plasma concentration-time curve from time zero extrapolated to infinity, AUC(0-inf), of memantinol sourced in Memantinol® (JSC GEROPHARM, Russia) and Akatinol Memantine® (Merz Pharma GmbH & Co. KGaA, Germany)"|0 hours (pre-dose), as well as at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 16, 24, 36, 48 and 72 hours post-dose||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2537862|NCT03121612|Secondary|Sentinel Outcome #8|Death of the infant before hospitals discharge|From date and time of randomization to date and time of hospital discharge, assessed to a maximum of 2 months of age.|The infant that died recovered after CPAP but was subsequently treated for apnoeas and a patent ductus arteriosus. Twelve days after CPAP cessation the infant commenced antibiotics for elevated CRP and was intubated and ventilated and died. The Data Safety Monitoring Committee determined that the death was unrelated to treatment group.|||Participants|||Count of Participants
2537863|NCT03121612|Secondary|Sentinel Outcome #7|For infants born at 28+0 to 33+6 weeks' gestation, oxygen dependent at 36 weeks' gestation|From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.||||Participants|||Count of Participants
2537864|NCT03121612|Secondary|Sentinel Outcome #6|"Intubation and mechanical ventilation~Note. An SpO2 target of 90-95% reflects currently recommended practice for neonates. FiO2 and SpO2 at time of intubation and ventilation not separately recorded, so we report this endpoint as recorded by clinicians, assuming that they have verified FiO2 [≥ 60% for ≥ 1 hour] and SpO2 [targeting 90-95%] requirements at the time of intubation and ventilation. If SpO2 was actually >95% (not 90-95%) at the time of intubation and ventilation, then FiO2 would be higher than required to meet the target range, by an unknown amount (possibly not meeting the FiO2 threshold of ≥ 60% for ≥ 1 hour, required to justify intubation and ventilation). We note this potential source of contamination because the results of Outcome #2 show that the majority of SpO2 readings were >95%."|From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.||||Participants|||Count of Participants
2537865|NCT03121612|Secondary|Sentinel Outcome #5|FiO2 ≥ 60% to maintain SpO2 at 90-95% for one hour or more, during CPAP treatment|From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.||||Participants|||Count of Participants
2537866|NCT03121612|Secondary|Sentinel Outcome #4|Intra-ventricular haemorrhage (IVH), intra-cranial haemorrhage (ICH), or periventricular leukomalacia (PVL) as diagnosed by cranial ultrasound scan|From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.||||Participants|||Count of Participants
2537867|NCT03121612|Secondary|Sentinel Outcome #3|Pneumothorax as diagnosed by X-ray|From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.||||Participants|||Count of Participants
2537868|NCT03121612|Secondary|Sentinel Outcome #2|Damage to the nares of the infant|From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.||||Participants|||Count of Participants
2537869|NCT03121612|Secondary|Sentinel Outcome #1|Damage to the nasal septum|From date and time of randomization to date and time of CPAP cessation, assessed to a maximum of 2 months of age.||||Participants|||Count of Participants
2537870|NCT03121612|Secondary|Serious Adverse Event|"A Serious adverse Event (SAEs) is any untoward medial occurrence that:~Results in death;~Is life-threatening; [NOTE: the term life-threatening in the definition of serious refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.]~Requires inpatient hospitalisation or prolongation of existing hospitalisation;~Results in persistent or significant disability/incapacity, or~Is a congenital anomaly/birth defect"|From date and time of birth to date and time of hospital discharge, assessed to a maximum of 2 months of age.|The infant that died recovered after CPAP but was subsequently treated for apnea and a patent ductus arteriosus. Twelve days after CPAP cessation the infant commenced antibiotics for elevated CRP and was intubated and ventilated and died. The Data Safety Monitoring Committee determined that the death was unrelated to treatment group.|||Participants|||Count of Participants
2537871|NCT03121612|Secondary|CPAP Duration|Duration of CPAP treatment (hours) in infants that do not fail CPAP|From date and time of randomization to date and time of cessation of CPAP treatment, or until date and time of hospital discharge, if infant is on CPAP treatment until discharged (i.e., dies or is transferred), assessed to a maximum of 2 months of age.|Excludes 3 Dolphin and 2 FP randomised infants that failed treatment (escalated to mechanical ventilation)|||Hours||Inter-Quartile Range|Median
2537872|NCT03121612|Secondary|CPAP Failure or Surfactant Provision|"Outcomes 6 or 7~Note that endpoint likely corrupted because SpO2 was not routinely targeting 90-95%, and large number of infants received surfactant before achieving >40% or without having x-ray confirmation of RDS."|From date and time of randomization to date and time of cessation of CPAP treatment, or until date and time of hospital discharge, if infant is on CPAP treatment until discharged (i.e., dies or is transferred), assessed to a maximum of 2 months of age.||||Participants|||Count of Participants
2537873|NCT03121612|Secondary|Surfactant Provided When FiO2 > 40% to Maintain SpO2 at 90-95% for ≥ 30 Minutes, With Respiratory Distress Syndrome Confirmed by Chest X-Ray|"Surfactant provided when FiO2 > 40% to maintain SpO2 at 90-95% for ≥ 30 minutes, with Respiratory Distress Syndrome confirmed by chest X-Ray~Note that endpoint likely corrupted because SpO2 was not routinely targeting 90-95%, and large number of infants received surfactant before achieving >40% or without having x-ray confirmation of RDS."|From date and time of randomization to date and time of cessation of CPAP treatment, or until date and time of hospital discharge, if infant is on CPAP treatment until discharged (i.e., dies or is transferred), assessed to a maximum of 2 months of age.||||Participants|||Count of Participants
2537874|NCT03121612|Secondary|Number of Participants Who Died or Needed Intubation and/or Mechanical Ventilation, as a Measure of CPAP Failure, Measured to Date and Time of Cessation of CPAP Treatment|"Death or need for intubation and mechanical ventilation as demonstrated by an FiO2 requirement ≥ 60% for ≥ 1 hour to maintain SpO2 at 90-95%~Note. An SpO2 target of 90-95% reflects currently recommended practice for neonates. FiO2 and SpO2 at time of intubation and ventilation not separately recorded, so we report this endpoint as recorded by clinicians, assuming that they have verified FiO2 [≥ 60% for ≥ 1 hour] and SpO2 [targeting 90-95%] requirements at the time of intubation and ventilation. If SpO2 was actually >95% (not 90-95%) at the time of intubation and ventilation, then FiO2 would be higher than required to meet the target range, by an unknown amount (possibly not meeting the FiO2 threshold of ≥ 60% for ≥ 1 hour, required to justify intubation and ventilation). We note this potential source of contamination because the results of Outcome #2 show that the majority of SpO2 readings were >95%."|From date and time of randomization to date and time of cessation of CPAP treatment, or until date and time of hospital discharge, if infant is on CPAP treatment until discharged (i.e., dies or is transferred), assessed to a maximum of 2 months of age.||||Participants|||Count of Participants
2537875|NCT03121612|Secondary|Partial Pressure of Arterial Carbon Dioxide (PaCO2)|PaCO2 measured as a change from baseline (where measured)|6, 12, 24, 48 and 72 hours after treatment commencement (where available)|Only 31/51 infants had a baseline blood gas taken, and only 7 of these had a second or subsequent test, with five of them at 6 hours, two each at 12 and 24 hours and one each at 48 and 72 hours. No statistical testing performed.|||Torr||Inter-Quartile Range|Median
2537876|NCT03121612|Secondary|Partial Pressure of Arterial Oxygen (PaO2)|PaO2 measured as a change from baseline (where measured)|6, 12, 24, 48 and 72 hours after treatment commencement (where available)|Only 31/51 infants had a baseline blood gas taken, and only 7 of these had a second or subsequent test, with five of them at 6 hours, two each at 12 and 24 hours and one each at 48 and 72 hours. No statistical testing performed.|||Torr||Inter-Quartile Range|Median
2537877|NCT03121612|Secondary|Arterial pH|pH measured as a change from baseline (where measured)|6, 12, 24, 48 and 72 hours after treatment commencement (where available)|Only 31/51 infants had a baseline blood gas taken, and only 7 of these had a second or subsequent test, with five of them at 6 hours, two each at 12 and 24 hours and one each at 48 and 72 hours. No statistical testing performed.|||pH||Inter-Quartile Range|Median
2537878|NCT03121612|Secondary|Respiratory Rate|Respiratory rate (breaths/minute), measured as a change from baseline|6, 12, 24, 48 and 72 hours after treatment commencement|"Number missing (and thus imputed):~6 hrs: 1 Dolphin (failed), 0 FP~12 hrs: 1 Dolphin (failed), 1 FP (recovered)~24 hrs: 6 Dolphin (2 failed + 4 recovered), 4 FP (all recovered)~48 hrs: 16 Dolphin (3 failed + 13 recovered), 11 FP (1 failed + 10 recovered)~72 hrs: 21 Dolphin (3 failed + 18 recovered), 21 FP (1 failed + 20 recovered)"|||Breaths per minute||Inter-Quartile Range|Median
2537879|NCT03121612|Secondary|SpO2|"Oxygen saturation by pulse oximetry (SpO2), measured as a change from baseline~Note. Outcome contaminated. An SpO2 target of 90-95% reflects currently recommended practice for neonates. The majority of readings were at SpO2 > 95%, above SpO2 target (90-95%)."|6, 12, 24, 48 and 72 hours after treatment commencement|"Number missing:~6 hrs: 1 Dolphin (failed), 0 FP~12 hrs: 1 Dolphin (failed), 1 FP (recovered)~24 hrs: 6 Dolphin (2 failed + 4 recovered), 4 FP (all recovered)~48 hrs: 16 Dolphin (3 failed + 13 recovered), 11 FP (1 failed + 10 recovered)~72 hrs: 21 Dolphin (3 failed + 18 recovered), 21 FP (1 failed + 20 recovered)"|||Percentage capillary oxygen saturation||Inter-Quartile Range|Median
2537880|NCT03121612|Primary|FiO2|"Fraction of inspired oxygen (FiO2), measured as a change from baseline as shown on the two machines.~Note. Outcome contaminated. An SpO2 target of 90-95% reflects currently recommended practice for neonates; when SpO2 exceeds the target, FiO2 should be reduced. The majority of readings were at SpO2 > 95%, so FiO2 for these SpO2 readings reflects oxygen provided, not oxygen required to achieve the recommended SpO2 target range (i.e., the FiO2 provided was excessive, by an unknown amount)."|6, 12, 24, 48 and 72 hours after treatment commencement|"Number missing at each time point:~6 hrs: 1 Dolphin (failed), 0 FP~12 hrs: 1 Dolphin (failed), 1 FP (recovered)~24 hrs: 6 Dolphin (2 failed + 4 recovered), 4 FP (all recovered)~48 hrs: 16 Dolphin (3 failed + 13 recovered), 11 FP (1 failed + 10 recovered)~72 hrs: 21 Dolphin (3 failed + 18 recovered), 21 FP (1 failed + 20 recovered)"|||Percentage of inspired oxygen||Inter-Quartile Range|Median
2537881|NCT03121365|Secondary|StimQ READ Subscale Change Score|"Differences in StimQ READ Subscale scores collected approximately 1 month after the 6, 9, and 12 month well visits.~Reading activity is measured using the StimQ READ subscale. This contains yes/no questions reflecting access to books, frequency of shared reading, and variety of books read in homes of young children, ages 5 to 36 months. The StimQ-Infant READ subscale is for use with infants 5-12 months of age and the StimQ-Toddler READ subscale is used with toddlers 12-36 months of age. The StimQ Infant and Toddler Read Subscales include a point scale for measuring cognitive stimulation resulting from the reading activity. Scores for the StimQ-Infant READ scale range from 0-15 with higher scores (greater number values) reflective of higher reading exposure. Scores for the StimQ-Toddler READ scale range from 0-19 with higher scores (greater number values) reflective of higher reading exposure."|1 month after the 6, 9, and 12 month well visits|The variation in number analyzed per row is reflective of participants who had incomplete measures at different study time-points which prevented analysis of their [missing] scores since the analysis is a comparison of scores at different study time-points.|||units on a scale||Standard Deviation|Mean
2537882|NCT03121365|Primary|Bayley Scales of Infant and Toddler Development (Infant is 12-18 Months Old)|"Evaluation of the infant's cognitive, language and motor development using the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III).~Results were reported as composites of cognitive, language, and motor scores, where data were continuous variables on a scale with a normal distribution of 95%. The composite scores are scaled to a metric with a mean of 100 and a standard deviation of 15, and range from 40-160. A composite score above 77.5 is considered developmentally average and a composite score below 77.5 is considered a developmental concern. Data were described using mean and standard deviation. Significance was considered at a level of 0.05."|Second Study visit (approximately one month after child is age-eligible for 12 month well child visit)||||score on a scale||Standard Deviation|Mean
2537883|NCT03120676|Primary|Progression-free Survival|The primary endpoint will be computed as proportions along with exact 95% confidence intervals.|12 months|Data not collected||||||
2537884|NCT03120520|Secondary|Change From Baseline in the Weekly Rate of Complete Spontaneous Bowel Movements (CSBM)|The weekly Complete Spontaneous Bowel Movement (CSBM) totals are derived from the daily diary entries reported during the Treatment Period in the Bowel Movement (BM) and symptom diaries. Baseline is the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. Spontaneous Bowel Movement (SBM) was defined as a bowel movement that occurs in the absence of laxative use within the preceding 24 hours. CSBM was defined as a spontaneous bowel movement with the sense of complete evacuation.|8 weeks|All randomized participants|||Weekly CSBMs||Standard Error|Least Squares Mean
2537885|NCT03120520|Secondary|Change From Baseline in the Weekly Rate of Spontaneous Bowel Movements (SBM)|The weekly Spontaneous Bowel Movement (SBM) totals were derived from the daily diary entries reported during the Treatment Period in the Bowel Movement (BM) and symptom diaries. Baseline was the mean number of SBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. SBM is defined as a bowel movement that occurs in the absence of laxative use within the preceding 24 hours|8 weeks|All randomized participants|||Weekly SBMs||Standard Error|Least Squares Mean
2537886|NCT03120520|Secondary|Change From Baseline in Weekly Average Stool Consistency Bristol Stool Form Scale (BSFS) Score|Stool consistency was assessed via the 7-point (1-7) Bristol Stool Form Scale (BSFS) and recorded in the bowel movement (BM) and Symptom Diaries. Lower numbers represent more formed stools; higher numbers represent less formed stools. The weekly mean BSFS score per patient = (total of all BSFS scores reported for a corresponding Spontaneous Bowel Movement (SBM) per time period)/n, where n = number of SBMs scored during the time period. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS types were 1) separate hard lumps, like nuts (hard to pass); 2) sausage-shaped but lumpy; 3) like a sausage but with cracks on its surface; 4) like a sausage or snake, smooth and soft; 5) soft blobs with clear-cut edges (passed easily); 6) fluffy pieces with ragged edges, a mushy stool; 7) watery, no solid pieces, entirely liquid.|8 weeks|All randomized participants|||units on a scale||Standard Error|Least Squares Mean
2537887|NCT03120520|Primary|Proportion of Overall Responders|An Overall Responder is a participant who was a Spontaneous Bowel Movement (SBM) responder for the last 2 weeks of the Treatment Period. An SBM responder is defined as a participant who had >3 SBMs per week. SBM was defined as a bowel movement that occurs in the absence of laxative use within the preceding 24 hours. Participants missing with respect to the outcome measure were scored as non-responders.|8 weeks|All randomized participants|||Participants|||Count of Participants
2537888|NCT03120351|Primary|Pain Disability Index Score (PDI) at Six Months Following Surgical Procedure|Pain Disability Index score (PDI) ranges from 0 to 70, with higher scores reflecting higher interference of pain with daily activities.|After surgery until postoperative day 7, 30, 90 and 180||||units on a scale||Standard Deviation|Mean
2537889|NCT03120013|Secondary|Change in the Short-Form Health Survey 36 (SF36) Score From Baseline|The Italian version of the Short-Form Health Survey 36 (SF-36): consists of 36 scaled score, yielding a total score of 0 (more disability) to 100 (less disability).|Baseline - 2 weeks - 1 month - 3 months||||units on a scale||Standard Deviation|Mean
2537890|NCT03120013|Secondary|Change in Cerebellar Brain Inhibition (CBI) Measurements From Baseline|Cerebellar brain inhibition (CBI) is expressed as motor evoked potential amplitude (average of 10 recordings). Lower values reflect higher inhibition and thus reduced impairment.|Baseline - 2 weeks - 1 month - 3 months||||millivolts||Standard Deviation|Mean
2537891|NCT03120013|Secondary|Change in the 8-Meter Walking Time (8MW) Score From Baseline|4 timed trials of the 8 meter walking time (8MW) were performed and averaged (mean values are reported). Longer times represent greater impairment.|Baseline - 2 weeks - 1 month - 3 months||||seconds||Standard Deviation|Mean
2537892|NCT03120013|Secondary|Change in the 9 Hole Peg Test (9HPT) Score From Baseline|4 timed trials of the 9 hole peg test (9HPT) were performed and averaged (mean values are reported) for each separate hand (dominant and nondominant). The total time to complete the task is recorded for each trial and for each separate hand (dominant and nondominant). Longer times represent greater impairment.|Baseline - 2 weeks - 1 month - 3 months||||seconds||Standard Deviation|Mean
2537893|NCT03120013|Secondary|Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline|Scale for the Assessment and Rating of Ataxia (SARA): 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia).|Baseline - 2 weeks - 1 month - 3 months||||units on a scale||Standard Deviation|Mean
2537894|NCT03120013|Secondary|Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline|International Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia).|Baseline - 2 weeks - 1 month - 3 months||||units on a scale||Standard Deviation|Mean
2537895|NCT03120013|Primary|Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline|Scale for the Assessment and Rating of Ataxia (SARA): 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia).|Baseline - 2 weeks||||units on a scale||Standard Deviation|Mean
2537896|NCT03120013|Primary|Change in the International Cooperative Ataxia Rating Scale (ICARS) Score From Baseline|International Cooperative Ataxia Rating Scale (ICARS): semi-quantitative 100-point scale, yielding a total score of 0 (no ataxia) to 100 (most severe ataxia).|Baseline - 2 weeks||||units on a scale||Standard Deviation|Mean
2537897|NCT03119831|Other Pre-specified|Total Bacterial Counts (TBC)|Levels of bacterial counts, expressed in total bacterial DNA mass (ng) and total number of bacteria. TBC was evaluated by real-time Polymerase Chain Reaction (PCR).|Plaque samples were collected at the 14th postsurgical day.|The inconsistency between the overall number of participants analyzed and the numbers provided in the rows in the participant flow module is due to the fact that there were no microbiological data from three patients in Group B and from another three participants in Group C, because their pooled plaque samples were destroyed during processing.|||log10 of copy numbers of bacterial DNA||Inter-Quartile Range|Median
2537898|NCT03119831|Secondary|Plaque Area Index (PA%)|Assessment of the accumulation of dental plaque at buccal tooth surfaces between baseline (immediately before surgery), 7 and 14 days postoperatively. PA% referred at the percentage of the total buccal surface area of the included teeth covered by dental plaque. PA% values range between 0-100%|PA% was recorded at the 7th and 14th postoperative day||||percentage of buccal surface area||Inter-Quartile Range|Median
2537899|NCT03119831|Secondary|Plaque Index (PI)|"PI measurements range between 0-3:~0 = No plaque~= A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.~= Moderate accumulation of soft deposits on the tooth and gingival margin which can be seen with the naked eye.~= Abundance of soft matter on the tooth and gingival margin."|PI was recorded 14 days postoperatively||||units on a scale||Inter-Quartile Range|Median
2537900|NCT03119831|Primary|Assessment of Periodontal Soft Tissue Healing Progress Between Baseline (Immediately After Surgery), 7 and 14 Days Postoperatively (Evaluated by Early Wound Healing Index - EHI)|"EHI measurements range between 1-5:~= Complete flap closure-no fibrin line in interproximal area.~= Complete flap closure-fibrin line in interproximal area.~= Complete flap closure-fibrin clot in the interproximal area.~= Incomplete flap closure-partial necrosis of interproximal tissue.~= Incomplete flap closure-complete necrosis of the interproximal tissue."|Early Wound Healing Index was recorded at the 7th and 14th postsurgical day||||units on a scale||Inter-Quartile Range|Median
2537901|NCT03119688|Secondary|Change From Baseline in Skin Moisturisation at Day 5|Corneometry was used to measure moisture content of stratum corneum using corneometer. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. Between the gold conductors of the probe an electrical field was built which allowed the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content, the stratum corneum moisturisation can be measured. The Corneometer probe was placed in contact with the skin of the paarticipant's test site for 1-2 seconds per measurement. The Corneometer measurements were taken and an average (mean) reading was calculated for each site and time point. Corneometer values lower than 30 instrumental units (i.u.) represents very dry skin, while values between 30 und 50 i.u are typically for dry skin on the forearm. An increase in Corneometer values, therefore, corresponds to a skin-moisturising effect.|At Baseline and Day 5 (3 hours post last wash procedure)|ITT population (N=48) was the primary population of analysis, which included all participants who were randomized and received at least one wash procedure, including sterile water, and had at least one post-baseline clinical assessment. Number of participants analyzed for this endpoint were part of the ITT population, evaluated on Day 5.|||i.u.||Standard Deviation|Mean
2537902|NCT03119688|Secondary|Change From Baseline in Transepidermal Water Loss (TEWL) at Day 5|TEWL was measured using Tewameter. TEWL measuring principle was based on water vapour gradient determination between two pairs of sensors placed at different distances perpendicularly to the skin. The probe was held in place on the skin for one measurement, for approximately 40 seconds (sec), to ensure that a stable value has been established. The first part of the measurement belonged to the equilibration phase. The values of the last 10 sec were averaged as the actual measurement values. An increase in TEWL values shows damage to the skin barrier function.|At Baseline and Day 5 (3 hours post last wash procedure)|ITT population (N=48) was the primary population of analysis, which included all participants who were randomized and received at least one wash procedure, including sterile water, and had at least one post-baseline clinical assessment. Number of participants analyzed for this endpoint were part of the ITT population, evaluated on Day 5.|||g/m^2/hr||Standard Deviation|Mean
2537903|NCT03119688|Secondary|Change From Baseline in Visual Assessment of Redness at Day 2, 3, and 4|Skin redness was assessed by a trained examiner according to following the scoring scale: 0 (No redness); 1(Barely detectable redness); 2(Slight redness); 3 (Moderate redness); 4 (Heavy or substantial redness); 5 (Extreme redness); 6 (Severe Redness). Lower scores reflect less skin redness.|At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure)|ITT population (N=48) was the primary population of analysis, which included all participants who were randomized and received at least one wash procedure, including sterile water, and had at least one post-baseline clinical assessment.|||Score on a scale||Standard Deviation|Mean
2537904|NCT03119688|Secondary|Change From Baseline in Visual Assessment of Dryness at Day 2, 3, and 4|Skin dryness was assessed by a trained examiner according to following the scoring scale: 0 (No dryness); 1 (Patches of slight powederiness and occasional patches of small scales may be seen, distribution generalized.); 2 (Generalised slight powederiness, early cracking or occasional small lifting scales may be present); 3 (Generalised moderate powederiness and/or heavy cracking and lifting scales; 4 (Generalised heavy powederiness and/or heavy cracking and lifting scales); 5 (Generalised high cracking and lifting scales, eczematous change may be present, powederiness may be present but not prominent, may see bleeding crack); 6 (Generalised severe cracking, eczematous change may be present, bleeding cracks may be present, scale large may be beginning to disappear). Lower scores reflect less dry skin.|At Baseline and Day 2, 3, and 4 (3 hours post last wash procedure)|ITT population (N=48) was the primary population of analysis, which included all participants who were randomized and received at least one wash procedure, including sterile water, and had at least one post-baseline clinical assessment.|||Score on a scale||Standard Deviation|Mean
2537905|NCT03119688|Secondary|Change From Baseline in Visual Assessment of Redness at Day 5|Skin redness was assessed by a trained examiner according to following the scoring scale: 0 (No redness); 1(Barely detectable redness); 2(Slight redness); 3 (Moderate redness); 4 (Heavy or substantial redness); 5 (Extreme redness); 6 (Severe Redness). Lower scores reflect less skin redness.|At Baseline and Day 5 (3 hours post last wash procedure)|ITT population (N=48) was the primary population of analysis, which included all participants who were randomized and received at least one wash procedure, including sterile water, and had at least one post-baseline clinical assessment. Number of participants analyzed for this endpoint were part of the ITT population, evaluated on Day 5.|||Score on a scale||Standard Deviation|Mean
2537917|NCT03119649|Secondary|Mean Change From Baseline in the Respiratory Domain of the Cystic Fibrosis Questionnaire-Revised (CFQ-R) at Day 29|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. The respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), derived from Questions 40, 41, 42, 45, and 46 if at least 50% of the questions had non-missing data. The scale score ranged from 0-100; higher scores indicated fewer symptoms and better health-related quality of life with a negative change indicating a worsening of symptoms. A change of 4 is considered clinically relevant.|Prior to dosing on Days 1 and 29, or at early discontinuation|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2537966|NCT03118739|Other Pre-specified|Baseline MRI Variables - Radial Strain||Baseline|Total number differs from Study totals due to subject non compliance with MRI (exam not completed)|||% (change in percentage in LV dimension)||Standard Deviation|Mean
2537906|NCT03119688|Primary|Change From Baseline in Visual Assessment of Dryness at Day 5|Skin dryness was assessed by a trained examiner according to following the scoring scale: 0 (No dryness); 1 (Patches of slight powederiness and occasional patches of small scales may be seen, distribution generalized.); 2 (Generalised slight powederiness, early cracking or occasional small lifting scales may be present); 3 (Generalised moderate powederiness and/or heavy cracking and lifting scales; 4 (Generalised heavy powederiness and/or heavy cracking and lifting scales); 5 (Generalised high cracking and lifting scales, eczematous change may be present, powederiness may be present but not prominent, may see bleeding crack); 6 (Generalised severe cracking, eczematous change may be present, bleeding cracks may be present, scale large may be beginning to disappear). Lower scores reflect less dry skin.|At Baseline and Day 5 (3 hours post last wash procedure)|ITT population (N=48) was the primary population of analysis, which included all participants who were randomized and received at least one wash procedure, including sterile water, and had at least one post-baseline clinical assessment. Number of participants analyzed for this endpoint were part of the ITT population, evaluated on Day 5.|||Score on a scale||Standard Deviation|Mean
2537907|NCT03119662|Secondary|Blinded Independent Assessment of Image Quality/Diagnostic Confidence Using a 5-Point Scale|Blinded independent assessment of image quality/diagnostic confidence using a 5-point scale. Image quality/diagnostic confidence for all imaging studies was rated on a 5-point scale from 1 (poor) to 5 (excellent).|Month 6|Data were not collected, as planned analysis could not be performed due to early study termination.||||||
2537908|NCT03119662|Secondary|All Cause Mortality and Morbidity|Mortality (all cause death) and morbidity i.e. critical events.|From Baseline to Month 6|Data were not collected, as planned analysis could not be performed due to early study termination.||||||
2537909|NCT03119662|Secondary|Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 By Waikar Criteria|Waikar's definitions of AKI: Stage 1: 0.3 mg/dL increase in SCr over 24 hours or a 0.5 mg/dL increase in SCr over 48 hours. Stage 2: 0.5 mg/dL increase in SCr over 24 hours or a 1.0 mg/dL increase in SCr over 48 hours. Stage 3: 1.0 mg/dL increase in SCr over 24 hours or a 1.5 mg/dL increase in SCr over 48 hours.|48 hours post-baseline (Follow-up 1)|Data were not collected, as planned analysis could not be performed due to early study termination.||||||
2537910|NCT03119662|Secondary|Assessment of the Incidence of Acute Kidney Injury (AKI) by Contrast Induced Nephropathy (CIN)|Standard definition of CIN: Increase in SCr of 0.5 mg/dL or more in the 24 to 72 hours after the CT scan.|48 hours post-baseline (Follow-up 1)|Data were not collected, as planned analysis could not be performed due to early study termination.||||||
2537911|NCT03119662|Secondary|Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria|AKIN Serum Creatinine Criteria for AKI- Stage 1: a SCr increase of >=0.3 mg/dL (>=26.4 μmol/L) or increase to >=150% to 200% (>=1.5- to 2.0-fold) from baseline within 48 hours. Stage 2: a SCr increase to >200% to 300% (>2.0- to 3-fold) from baseline within 48 hours. Stage 3: a SCr increase to >300% (>3.0-fold) from baseline or SCr >=4.0 mg/dL (>=354 μmol/L) with an acute increase of >=0.5 mg/dL (>=44 μmol/L) within 48 hours.|48 hours post-baseline (Follow-up 1)|Data were not collected, as planned analysis could not be performed due to early study termination.||||||
2537912|NCT03119662|Primary|Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=1 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria|AKIN Serum Creatinine Criteria for AKI- Stage 1: a SCr increase of >=0.3 mg/dL (>=26.4 μmol/L) or increase to >=150% to 200% (>=1.5- to 2.0-fold) from baseline within 48 hours. Stage 2: a SCr increase to >200% to 300% (>2.0- to 3-fold) from baseline within 48 hours. Stage 3: a SCr increase to >300% (>3.0-fold) from baseline or SCr >=4.0 mg/dL (>=354 μmol/L) with an acute increase of >=0.5 mg/dL (>=44 μmol/L) within 48 hours.|48 hours post-baseline (Follow-up 1)|Data were not collected, as planned analysis could not be performed due to early study termination.||||||
2537913|NCT03119649|Secondary|Mean Area Under the Concentration-Time Curve From Time 0 up to 24 Hours Following Multiple Dosing (AUC[0-t]; ng.h/mL) of GLPG2222|Area under the concentration-time curve from time 0 up to 24 hours following multiple dosing (ng.h/mL), calculated by linear up/log down trapezoidal summation. All PK parameters were determined from Day 15; Day 29 data were determined if the participant was not available for full PK profiling on Day 15.|Day 15 (predose and 0.5, 1, 2, 3, 4, 6, and 8 hours postdose) and prior to dosing on Day 29|PK Population; data were not calculable for 1 patient.|||ng.h/mL||Standard Deviation|Mean
2537914|NCT03119649|Secondary|Median Time to Occurrence of GLPG2222 Cmax (Tmax; Hours [h])|Time of occurrence of maximum concentration of GLPG2222 after multiple dosing (h), obtained directly from the observed concentration versus time data. All PK parameters were determined from Day 15; Day 29 data were determined if the participant was not available for full PK profiling on Day 15.|Day 15 (predose and 0.5, 1, 2, 3, 4, 6, and 8 hours postdose) and prior to dosing on Day 29|PK Population; data were not calculable for 1 patient.|||hours||Full Range|Median
2537915|NCT03119649|Secondary|Mean GLPG2222 Plasma Concentration Observed at Predose (Ctrough; ng/mL)|Plasma concentration of GLPG2222 observed at pre-dose (ng/mL), obtained directly from the observed concentration versus time data. Ctrough was calculated using both Day 15 and Day 29 PK data.|Days 15 and 29 (predose)|PK Population|||ng/mL||Standard Deviation|Mean
2537916|NCT03119649|Secondary|Mean Maximum Observed Plasma Concentration (Cmax; Nanograms Per Milliliter [mg/mL]) of GLPG2222|Maximum concentration of GLPG2222 after multiple dosing (ng/ML), obtained directly from the observed concentration versus time data. All pharmacokinetic (PK) parameters were determined from Day 15; Day 29 data were determined if the participant was not available for full PK profiling on Day 15.|Day 15 (predose and 0.5, 1, 2, 3, 4, 6, and 8 hours postdose) and prior to dosing on Day 29|Pharmacokinetic (PK) Population: all participants who were exposed to GLPG2222 and who had available and evaluable PK data (excluding all protocol violations/deviations or adverse events that may have had an impact on the PK analysis). Data were not calculable for 1 patient.|||ng/mL||Standard Deviation|Mean
2537918|NCT03119649|Secondary|Mean Change From Baseline in Percent (%) Predicted FEV1 (%FEV1) at Day 29|Percent predicted FEV1 for age, gender, and height was determined from standardized spirometry assessments and estimated using the 2012 Global Lungs Initiative equation. Baseline was defined as the last non-missing predose assessment on Day 1.|Predose and between 1 and 2 hours postdose on Days 1 and 29, or at early discontinuation|ITT Population|||% predicted FEV1||Standard Error|Least Squares Mean
2539488|NCT03070730|Secondary|Change in Physical Functioning-MFI From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Multidimensional Fatigue Inventory (MFI).|1 week after third intervention|||||||
2537919|NCT03119649|Secondary|Mean Change From Baseline in Sweat Chloride Concentration at Day 29|Two sweat collections, one from each arm, were obtained. Mean sweat chloride concentration was determined from both arms and measured as millimoles per liter (mmol/L). Baseline was defined as the predose value on Day 1 (or the last non-missing predose measurement).|Prior to dosing on Days 1 and 29, or at early discontinuation|Intent-to-treat (ITT) population: all enrolled participants who received at least one dose of study drug and had at least one post-baseline assessment with efficacy data. Only participants with non-missing data at baseline were included in the analysis; 3 participants had missing sweat chloride concentration data at baseline.|||mmol/L||Standard Error|Least Squares Mean
2537920|NCT03119649|Primary|Number of Participants With Treatment-Emergent Adverse Events|Number of participants with any treatment-emergent adverse events (TEAEs) and serious or treatment-related TEAEs, as well as number of patients with TEAEs by worst intensity reported (mild, moderate, or severe).|First administration (Day 1) through Follow-up (Day 43)|Safety population|||Participants|||Count of Participants
2537921|NCT03119181|Primary|Subject-reported Visual Analog Scale (VAS) Pain Score Following Tympanic Membrane Tap for Subjects Treated With Active Tymbion Iontophoresis Compared to VAS Score for Subjects Treated With Sham Tymbion Iontophoresis.|"The VAS consists of a 100 millimeter (mm) line with a statement at each end representing the extreme limits of pain intensity (where 0 represents No pain and 100 represents The worst imaginable pain). The subject reports their pain intensity by making a mark along the line and the line is measured to convert the subject response to numeric score (0-100 in millimeters). The data will be summarized as the difference in mean VAS scores between the two treatment groups (active Tymbion iontophoresis compared to sham Tymbion iontophoresis)."|Day 0||||millimeters||Standard Deviation|Mean
2537922|NCT03119168|Secondary|Intraprocedural Use of Simethicone|The number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope.|6-10 minutes||||colonoscopies|||Number
2537923|NCT03119168|Secondary|Colon Preparation|"Boston Bowel Preparation Scale (BBPS): scale that rates the quality of the colon preparation based on the amount of stool present. 0:solid stool that cannot be cleared; 1:areas not well seen due to residual stool and/or opaque liquid; 2:small fragments of stool and/or opaque liquid, but mucosa seen well; 3:no residual stool or opaque liquid seen. Score determined by adding the score of each individual segment of the colon (right side, transverse and left side). Scores range from 0 to 3 in each segment, therefore, a total composite score ranges from 0 (poor) to 9 (excellent).~Bubble Score (BS): scale that rates the amount of bubbles present in the colon. 0:no or minimal bubbles; 1:bubbles covering up to half the luminal diameter; 2:bubbles covering the circumference of the lumen; 3:bubbles filling the entire lumen. Score determined the same way as BBPS score but in this case a total score of 0 is excellent and 9 is poor."|25 minutes||||score on a scale||Standard Deviation|Mean
2537924|NCT03119168|Secondary|Withdrawal Times|Amount spent withdrawing the scope during the colonoscopy|6-10 minutes||||seconds||Standard Deviation|Mean
2537925|NCT03119168|Primary|Adenoma Detection Rate|The number of adenomatous polyps removed at colonoscopy|25 minutes||||adenomas|||Number
2537926|NCT03119025|Secondary|Number of Participants Who Have Developed or Increased Anti-Viral Immune Response According to IFN-γ Production|Change from baseline in T-cell IFN-γ-producing response to HCV Core and NS3 proteins at 2, 7 and 13 month after 1-st vaccination. Production of IFN-γ will be measured by ELISA kit|Baseline, 2, 7 and 13 months after 1-st vaccination||||Participants|||Count of Participants
2537927|NCT03119025|Secondary|Number of Participants Who Have Developed or Increased Anti-Viral Immune Response According to T-cell Proliferation|Change from baseline in T-cell proliferative response to HCV Core and NS3 proteins at 2, 7 and 13 month after 1-st vaccination. T-cell proliferation will be evaluated using radiometry based on 3H-thymidine incorporation|Baseline, 2, 7, and 13 months after 1-st vaccination||||Participants|||Count of Participants
2537928|NCT03119025|Secondary|Number of Participants With Virological Response According to HCV RNA Viral Load|Virological response in patients receiving DC-vaccinations is defined as change from baseline in HCV RNA viral load by at least 1 log at 2, 7 and 13 month after 1-st vaccination. Plasma level of HCV RNA will be measured by Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR)|Baseline, 2, 7 and 13 months after 1-st vaccination||||Participants|||Count of Participants
2537929|NCT03119025|Primary|Number of Participants With Severe Adverse Reactions and/or With Abnormal Clinical Laboratory Values That Are Related to Treatment|Frequency of severe adverse reactions will be evaluated from enrollment and up to 13 months. Liver safety by blood analysis (ALT, AST, GGT, Total and conjugated bilirubin, platelets, ESR, etc) and Ultrasound will be assessed from enrollment and up to 13 months (= baseline, 2, 7 and 13 months after 1-st vaccination).|From enrollment and up to 13 months|Most patients had minimal hepatitis activity as evidenced by normal or slightly increased liver transaminase levels. Serum HCV RNA levels ranged from 1.3 × 104 IU/mL to 1.8 × 106 IU/mL. Fibrosis stage ranged from F0 to F3 according to Metavir system scores.|||Participants|||Count of Participants
2537930|NCT03118947|Primary|Treatment Emergent Adverse Events (TEAEs)|Safety and tolerability of pimavanserin after 52 weeks of treatment in patients with probable Alzheimer's disease who have symptoms of agitation and Aggression, in terms of occurrence of TEAEs|52 weeks|Treated patients (i.e. patients receiving at least 1 dose of open-label study drug)|||Participants|||Count of Participants
2537931|NCT03118934|Primary|Mean Number of Trial Lenses Needed to Fit Each Eye|The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit|VIsit 1/Day 1|This analysis population includes all subjects randomized or assigned to study lenses as applicable, and exposed to study lenses including trial fit at Visit 1 (Full Analysis Set).|||lenses|Eyes|Standard Deviation|Mean
2537932|NCT03118843|Secondary|Change From Baseline in HCV RNA||Baseline; Weeks 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2537933|NCT03118843|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after 2 consecutive HCV RNA < LLOQ), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit"|Up to Posttreatment Week 12|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2537938|NCT03118765|Secondary|Change From Baseline in Time-normalized Area Under the Curve for FEV1 Measured Over 12 Hours on Day 21|Least Square Mean (SE) change from baseline in time-normalized area under the curve for FEV1 Measured Over 12 Hours on Day 21.|Day 21(Pre-dose FEV1 at -45 mins and 15 mins prior to dosing on Day 21. On Day 21, FEV1 at post-dose at 5 mins ±3, 15 mins ±2, 30 mins ±5, 60 mins, 90 mins, and 2 hours; and post-dose at 4, 6, 8, 10, 12 hours after the morning dose).|Full Analysis Set (FAS) included all subjects who were randomized, had received at least 1 dose of study drug and had at least 1 post-baseline PD assessment.|||Litre||Standard Error|Least Squares Mean
2537939|NCT03118765|Secondary|Change From Baseline in Time-normalized Area Under the Curve for FEV1 Measured Over 12 Hours on Day 1|Least Square Mean (SE) change from baseline in time-normalized area under the curve for FEV1 measured over 12 hours on Day 1.|Day 1 (Pre-dose FEV1 at -45 mins and 15 mins prior to dosing on Day 1. On Day 1 FEV1 at post-dose at 5 mins ±3, 15 mins ±2, 30 mins ±5, 60 mins, 90 mins, and 2 hours; and post-dose at 4, 6, 8, 10, 12 hours after the morning dose).|Full Analysis Set (FAS) included all subjects who were randomized, had received at least 1 dose of study drug and had at least 1 post-baseline PD assessment.|||Litre||Standard Error|Least Squares Mean
2537940|NCT03118765|Secondary|Change From Baseline in Forced Vital Capacity (FVC) on Day 21|Least Square Mean change from baseline in forced vital capacity (FVC) to end of Day 21|Day 21 (Pre-dose FVC at -45 mins and 15 mins prior to dosing on Day 21. Postdose timing were relative to the end of dosing. The window for 1 hour spirometry and thereafter was ±5 minutes).|Full Analysis Set (FAS) included all subjects who were randomized, had received at least 1 dose of study drug and had at least 1 post-baseline PD assessment.|||Litre||Standard Error|Least Squares Mean
2537941|NCT03118765|Secondary|Change From Baseline in Forced Vital Capacity (FVC) on Day 1|Least Square Mean change from baseline in forced vital capacity (FVC) to end of Day 1.|Day 1 (Pre-dose FVC at -45 mins and 15 mins prior to dosing on Day 1. Postdose timing were relative to the end of dosing.The window for 1 hour spirometry and thereafter was ±5 minutes).|Full Analysis Set (FAS) included all subjects who were randomized, had received at least 1 dose of study drug and had at least 1 post-baseline PD assessment.|||Litre||Standard Error|Least Squares Mean
2537942|NCT03118765|Secondary|Change From Baseline in Peak FEV1 Within 12 Hours Post-dose on Day 21|The least square mean change from baseline to peak FEV1 within 12 hours postdose on Day 21. Change from baseline in peak FEV1 within 12 hours postdose on Day 21 was derived from the serial readings taken through 12 hours postdose and calculating the change from baseline.|Day 21(Pre-dose FEV1 at -45 mins and 15 mins prior to dosing on Day 21. On Day 21, FEV1 at post-dose at 5 mins ±3, 15 mins ±2, 30 mins ±5, 60 mins, 90 mins, and 2 hours; and post-dose at 4, 6, 8, 10, 12 hours after the morning dose).|Full Analysis Set (FAS) included all subjects who were randomized, had received at least 1 dose of study drug and had at least 1 post-baseline PD assessment.|||Litre||Standard Error|Least Squares Mean
2537943|NCT03118765|Secondary|Change From Baseline in Peak FEV1 Within 12 Hours Post-dose on Day 1|The least square mean change from baseline to peak FEV1 within 12 hours postdose on Day 1. Change from baseline in peak FEV1 within 12 hours postdose on Day 1 was derived from the serial readings taken through 12 hours postdose and calculating the change from baseline.|Day 1 (Pre-dose FEV1 at -45 mins and 15 mins prior to dosing on Day 1. On Day 1 FEV1 at post-dose at 5 mins ±3, 15 mins ±2, 30 mins ±5, 60 mins, 90 mins, and 2 hours; and post-dose at 4, 6, 8, 10, 12 hours after the morning dose).|Full Analysis Set (FAS) included all subjects who were randomized, had received at least 1 dose of study drug and had at least 1 post-baseline PD assessment.|||Litre||Standard Error|Least Squares Mean
2537944|NCT03118765|Secondary|Accumulation Ratio Rac(Cmax)|Descriptive statistics for tiotropium plasma PK parameter-Accumulation ratio Rac(cmax). Rac(Cmax) was calculated as CmaxSS/Cmax.|Day 21|Overall Number of Participants Analyzed is the number of subjects with data in the Pharmacokinetic Analysis Set (PKAS). PKAS included all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 quantifiable PK sample and did not have exclusionary major protocol deviations.|||ratio||Standard Deviation|Mean
2537945|NCT03118765|Secondary|Accumulation Ratio Rac(Auc)|Descriptive statistics for tiotropium plasma PK parameter-Accumulation ratio Rac(auc). Rac(auc) was calculated as AUC0-tauSS/AUC0-tau.|Day 21|Overall Number of Participants Analyzed is the number of subjects with data in the Pharmacokinetic Analysis Set (PKAS). PKAS included all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 quantifiable PK sample and did not have exclusionary major protocol deviations.|||ratio||Standard Deviation|Mean
2537946|NCT03118765|Secondary|Average Concentration During a Dosing Interval at Steady State (CavSS) on Day 21|Descriptive statistics for tiotropium plasma PK parameter - Average concentration during a dosing interval at steady state (CavSS) on day 21|Day 21|Overall Number of Participants Analyzed is the number of subjects with data in the Pharmacokinetic Analysis Set (PKAS). PKAS included all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 quantifiable PK sample and did not have exclusionary major protocol deviations.|||pg/mL||Standard Deviation|Mean
2537947|NCT03118765|Secondary|Time of Peak Drug Concentration Over the Dosing Interval (Tmax) on Day 21|Descriptive statistics for tiotropium plasma PK parameter - Time of peak drug concentration over the dosing interval (tmax) on Day 21|Day 21|Overall Number of Participants Analyzed is the number of subjects with data in the Pharmacokinetic Analysis Set (PKAS). PKAS included all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 quantifiable PK sample and did not have exclusionary major protocol deviations.|||hour||Full Range|Median
2537948|NCT03118765|Secondary|Time of Peak Drug Concentration Over the Dosing Interval (Tmax) on Day 1|Descriptive statistics for tiotropium plasma PK parameter - Time of peak drug concentration over the dosing interval (tmax) on Day 1|Day 1|Overall Number of Participants Analyzed is the number of subjects with data in the Pharmacokinetic Analysis Set (PKAS). PKAS included all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 quantifiable PK sample and did not have exclusionary major protocol deviations.|||hour||Full Range|Median
2537949|NCT03118765|Secondary|Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC0-tau) on Day 1|Descriptive statistics for tiotropium plasma PK parameter - Area under the plasma concentration-time curve over the dosing interval (AUC0-tau) on Day 1|Day 1|Overall Number of Participants Analyzed is the number of subjects with data in the Pharmacokinetic Analysis Set (PKAS). PKAS included all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 quantifiable PK sample and did not have exclusionary major protocol deviations.|||pg*h/mL||Standard Deviation|Mean
2537950|NCT03118765|Secondary|Peak Concentrations During the Dosing Interval (Cmax) on Day 1|Descriptive statistics for tiotropium plasma PK parameters - (Cmax) on Day 1|Day 1|Overall Number of Participants Analyzed is the number of subjects with data in the Pharmacokinetic Analysis Set (PKAS). PKAS included all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 quantifiable PK sample and did not have exclusionary major protocol deviations.|||pg/mL||Standard Deviation|Mean
2537951|NCT03118765|Secondary|Fraction of Dose (Fe) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21|Descriptive statistics for tiotropium urine PK parameter-Fraction of Dose (Fe) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21|Day 21|Overall Number of Participants Analyzed is the number of subjects with data in the Pharmacokinetic Analysis Set (PKAS). PKAS included all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 quantifiable PK sample and did not have exclusionary major protocol deviations.|||percentage of dose||Standard Deviation|Mean
2537952|NCT03118765|Secondary|Fraction of Dose (Fe) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 1|Descriptive statistics for tiotropium urine PK parameter - Fraction of dose (Fe) of tiotropium excreted in urine over the dosing interval on Day 1|Day 1|Overall Number of Participants Analyzed is the number of subjects with data in the Pharmacokinetic Analysis Set (PKAS). PKAS included all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 quantifiable PK sample and did not have exclusionary major protocol deviations.|||percentage of dose||Standard Deviation|Mean
2537953|NCT03118765|Secondary|Amount (Aetau) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21|Descriptive statistics for tiotropium urine PK parameter - Amount (Aetau) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 21|Day 21|Overall Number of Participants Analyzed is the number of subjects with data in the Pharmacokinetic Analysis Set (PKAS). PKAS included all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 quantifiable PK sample and did not have exclusionary major protocol deviations.|||pg||Standard Deviation|Mean
2537954|NCT03118765|Secondary|Amount (Aetau) (Cumulative Amount of Unchanged Drug Excreted Into the Urine Over the Dosing Interval) of Tiotropium Excreted in Urine Over the Dosing Interval on Day 1|Descriptive statistics for tiotropium urine PK parameter - Amount (Aetau) of tiotropium excreted in urine over the dosing interval on Day 1|Day 1|Overall Number of Participants Analyzed is the number of subjects with data in the Pharmacokinetic Analysis Set (PKAS). PKAS included all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 quantifiable PK sample and did not have exclusionary major protocol deviations.|||pg||Standard Deviation|Mean
2537955|NCT03118765|Primary|Change From Baseline (Day 1) in Trough FEV1 at 24 Hours After the Last Dose of Treatment on Day 21 in Comparison to Placebo.|Change from baseline (Day 1) at Day 21 (Week 3) in trough FEV1 response at approximately 24 hours after the last dose (average of 23 hours 15 minutes and 23 hours 45 minutes postdose measurements), in comparison with placebo.|21 days (Pre- dose trough FEV1 is mean FEV1 at -45 mins and -15 mins pre-morning dose at Day 1. Trough FEV1 is mean FEV1 obtained 23 hrs 15 mins and 23 hrs 45 mins post-morning dose of day 21).||||L||Standard Error|Mean
2537956|NCT03118765|Primary|Relative Bioavailability of Tiotropium With GSP 304 in Comparison to SPIRIVA RESPIMAT 5 μg Based on AUC0-tauSS|The PK endpoint in plasma to assess the relative bioavailability was area under the plasma concentration-time curve of tiotropium over the dosing interval at steady state (AUC0-tauSS)|Plasma concentrations on day 21 according to the below schedule: Pre-dose (0 hour), and at 2, 4, 6, 10, 15, 30, and 45, 60, 75, and 90 minutes post-dose, as well as 2, 4, 6, 8, 12, 16, 20 and 24 hours post-dose.|The PK analysis set consisted of all subjects who were randomized, received at least 1 dose of study treatment, and had at least 1 quantifiable PK sample and did not have an exclusionary major protocol deviation.|||h*pg/mL||Standard Error|Mean
2537957|NCT03118765|Primary|Relative Bioavailability of Tiotropium With GSP304 in Comparison to SPIRIVA RESPIMAT 5 μg Based on CmaxSS|The PK endpoint in plasma to assess the relative bioavailability was peak concentrations of tiotropium during the dosing interval at steady-state (CmaxSS)|Plasma concentrations on day 21 according to the below schedule: Pre-dose (0 hour), and at 2, 4, 6, 10, 15, 30, and 45, 60, 75, and 90 minutes post-dose, as well as 2, 4, 6, 8, 12, 16, 20 and 24 hours post-dose.|The PK analysis set consisted of all subjects who were randomized, received at least 1 dose of study treatment, and had at least 1 quantifiable PK sample and did not have an exclusionary major protocol deviation.|||pg/mL||Standard Error|Mean
2537958|NCT03118739|Primary|Urinary Albumin to Creatinine Ratio (UACR)|LS Mean Percentage Change (95% CI) from Baseline in UACR|From Baseline to 24 Weeks of Treatment|Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations|||Precent change||95% Confidence Interval|Least Squares Mean
2537959|NCT03118739|Other Pre-specified|Baseline Flow Mediated Dilatation (Reactive Hyperemia)|"Baseline in Flow Mediated Dilatation. The flow mediated dilatation metric is obtained using a device from Cordex, and a proprietary algorithm.~This metric represents the volume difference between a baseline arterial compliance curve and hyperemia arterial compliance curve in the positive transmural pressure region. This metric has a direct relationship to a subject's cardiovascular condition. Output range is 0-150. A higher score is indicative of a better flow mediated dilatation."|Baseline|Total number differs from Study totals due to subject non compliance with exam (exam not completed)|||Units on a scale||Standard Deviation|Mean
2537960|NCT03118739|Other Pre-specified|Baseline MRI Variables - LV Stroke Volume||Baseline|Total number differs from Study totals due to subject non compliance with MRI (exam not completed)|||mL||Standard Deviation|Mean
2537961|NCT03118739|Other Pre-specified|Baseline MRI Variables - LV Mass/End-diastolic Volume||Baseline|Total number differs from Study totals due to subject non compliance with MRI (exam not completed)|||g/mL||Standard Deviation|Mean
2537962|NCT03118739|Other Pre-specified|Baseline MRI Variables - LV Mass||Baseline|Total number differs from Study totals due to subject non compliance with MRI (exam not completed)|||g||Standard Deviation|Mean
2537963|NCT03118739|Other Pre-specified|Baseline MRI Variables - Systolic Radial Strain Rate||Baseline|Total number differs from Study totals due to subject non compliance with MRI (exam not completed)|||s^-1||Standard Deviation|Mean
2537964|NCT03118739|Other Pre-specified|Baseline MRI Variables - Systolic Longitudinal Strain Rate||Baseline|Total number differs from Study totals due to subject non compliance with MRI (exam not completed)|||s^-1||Standard Deviation|Mean
2537982|NCT03118739|Other Pre-specified|Clinical Chemistry Values|Changes in Clinical Chemistry Values (CFB = Change for Baseline)|From Baseline to 12 Weeks and 24 Weeks of Treatment|Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations|||% hemoglobin bound to glucose||Standard Deviation|Mean
2537983|NCT03118739|Other Pre-specified|Urinalysis|Changes in Urinalysis (CFB = Change from Baseline)|From Baseline to 12 Weeks and 24 Weeks of Treatment|Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations|||mg/g||Standard Deviation|Mean
2537984|NCT03118739|Secondary|MRI Variables - LV Mass|Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline)|From Baseline to 24 Weeks of Treatment|Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations|||g||Standard Deviation|Mean
2537985|NCT03118739|Secondary|MRI Variables - Diastolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate and Systolic Circumferential Strain Rate, Longitudinal Strain Rate, Radial Strain Rate|Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline)|From Baseline to 24 Weeks of Treatment|Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations|||s^-1||Standard Deviation|Mean
2537986|NCT03118739|Secondary|MRI Variables - LV Ejection Fraction, Circumferential Strain, Longitudinal Strain, Radial Strain|Change from baseline in MRI Variables at Week 24 (CFB = Change from Baseline)|From Baseline to 24 Weeks of Treatment|Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations|||% (change in percentage from baseline)||Standard Deviation|Mean
2537987|NCT03118739|Secondary|MRI Variables - LV End-diastolic Volume, LV End-systolic Volume, LV Stroke Volume|Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline)|From Baseline to 24 Weeks of Treatment|Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations|||mL||Standard Deviation|Mean
2537988|NCT03118739|Secondary|MRI Variables - Kidney Cortex T2 Star - BOLD MRI|Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline)|From Baseline to 24 Weeks of Treatment|Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations|||ms||Standard Deviation|Mean
2537989|NCT03118739|Primary|Urinary Albumin to Creatinine Ratio (UACR) Compared to Placebo|LS Mean Percentage Change (90% CI) from Baseline in UACR Compared to Placebo|From Baseline to 24 Weeks of Treatment|Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations|||Precent change||90% Confidence Interval|Least Squares Mean
2537990|NCT03118739|Other Pre-specified|Clinical Chemistry Values|Changes in Clinical Chemistry Values (CFB = Change for Baseline)|From Baseline to 12 Weeks and 24 Weeks of Treatment|Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations|||pmol/L||Standard Deviation|Mean
2537991|NCT03118739|Other Pre-specified|Urinalysis|Changes in Urinalysis (CFB = Change from Baseline)|From Baseline to 12 Weeks and 24 Weeks of Treatment|Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations|||mg/dL||Standard Deviation|Mean
2537992|NCT03118739|Other Pre-specified|Flow Mediated Dilatation (Reactive Hyperemia)|"LS Mean Change (95% CI) from Baseline in Flow Mediated Dilatation. The flow mediated dilatation metric is obtained using a device from Cordex, and a proprietary algorithm.~This metric represents the volume difference between a baseline arterial compliance curve and hyperemia arterial compliance curve in the positive transmural pressure region. This metric has a direct relationship to a subject's cardiovascular condition. Output range is 0-150. A higher score is indicative of a better flow mediated dilatation."|From Baseline to 12 Weeks and 24 Weeks of Treatment|Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations|||Units on a scale||95% Confidence Interval|Least Squares Mean
2537993|NCT03118739|Secondary|MRI Variables - LV Mass/End-diastolic Volume|Change from Baseline in MRI Variables at Week 24 (CFB = Change from Baseline)|From Baseline to 24 Weeks of Treatment|Number analyzed at 24 weeks was less than the overall number analyzed due to missing observations|||g/mL||Standard Deviation|Mean
2537994|NCT03118739|Secondary|Clinical Assessments|Change from Baseline in Diastolic and Systolic Blood Pressure|From Baseline to 12 Weeks and 24 Weeks of Treatment|Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations|||mm/Hg||Standard Deviation|Mean
2537995|NCT03118739|Secondary|Serum High Sensitivity C-reactive Protein|LS Mean Percentage Change (95% CI) from Baseline in Serum High Sensitivity C-reactive Protein|From Baseline to 12 Weeks and 24 Weeks of Treatment|Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations|||Percent change||95% Confidence Interval|Least Squares Mean
2537996|NCT03118739|Secondary|Serum Cystatin C|LS Mean Percentage Change (95% CI) from Baseline in Serum Cystatin C|From Baseline to 12 Weeks and 24 Weeks of Treatment|Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations|||Percent change||95% Confidence Interval|Least Squares Mean
2537997|NCT03118739|Secondary|Serum Creatinine|LS Mean Percentage Change (95% CI) from Baseline in Serum Creatinine|From Baseline to 12 Weeks and 24 Weeks of Treatment|Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations|||Percent change||95% Confidence Interval|Least Squares Mean
2537998|NCT03118739|Secondary|eGFR|LS Mean Percentage Change (95% CI) from Baseline in eGFR|From Baseline to 12 Weeks and 24 Weeks of Treatment|Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations|||Percent change||95% Confidence Interval|Least Squares Mean
2537999|NCT03118739|Secondary|sUA|LS Mean Percentage Change (95% CI) from Baseline in sUA|From Baseline to 12 Weeks and 24 Weeks of Treatment|Number analyzed at 12 and 24 weeks was less than the overall number analyzed due to missing observations|||Percent change||95% Confidence Interval|Least Squares Mean
2538000|NCT03118739|Primary|Urinary Albumin to Creatinine Ratio (UACR)|LS Mean Percentage Change (95% CI) from Baseline in UACR|From Baseline to 12 Weeks of Treatment|Number analyzed at 12 weeks was less than the overall number analyzed due to missing observations|||Precent change||95% Confidence Interval|Least Squares Mean
2538104|NCT03111316|Secondary|To Evaluate the Proportion of Patients That Delivered by 12 Hours and Proportion of Patients Delivered by 24 Hours|To evaluate the proportion of patients that delivered vaginally by 12 hours and proportion of patients delivered vaginally by 24 hours.|24 hours||||Participants|||Count of Participants
2538001|NCT03118596|Secondary|Number of Participants With Type of Airway Maneuvers Performed During Tracheal Intubation,|The number of tube rotations performed during tracheal intubation|less than 3 minutes|In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation|||Participants|||Count of Participants
2538002|NCT03118596|Secondary|Time to Carinal View|The time from insertion of fibreoptic scope into the lumen of the SAD to the visualization of the carina.|less than 1 minute|In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation|||seconds||Standard Deviation|Mean
2538003|NCT03118596|Secondary|Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD|The quality of the view of the vocal cords seen through the SAD. It will be assessed, according to the previously published system, as: grade I - full view of the vocal cord, II - partial view of the vocal cords including arytenoids, III - epiglottis only, IV - other (SAD cuff, pharynx, others)|less than 3 minutes|In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation|||Participants|||Count of Participants
2538004|NCT03118596|Secondary|Number of Participants With First and Second Attempt at Tracheal Intubation|Number of attempts at tracheal intubation. A new attempt is defined as re-insertion of the fibreoptic bronchoscope through the SAD.|less than 3 minutes|IIn 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation|||Participants|||Count of Participants
2538005|NCT03118596|Secondary|Number of Participants With Ease of Placement of the SAD|"The ease of placement of the SAD assessed by the investigator on a four point scale:~- Easy~- Moderate Difficulty 3- Severe Difficulty~4 - Failure"|less than 2 minutes|In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation|||participants|||Number
2538006|NCT03118596|Secondary|Number of Attempts at the SAD Placement|Number of attempts taken to successfully place the supraglottic airway device in the oropharynx|less than 2 minutes|||||||
2538007|NCT03118596|Secondary|SAD Insertion Time|Time taken to insert the supra-glottic airway device measured from insertion into the mouth until the capnography trace is obtained|less than 1 minute|In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation|||seconds||Standard Deviation|Mean
2538008|NCT03118596|Primary|Total Intubation Time to Perform Fibreoptic Intubation|Time form insertion of bronchoscope through the supraglottic airway device to obtaining the capnography trace|less than 3 minutes|In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation|||seconds||Standard Deviation|Mean
2538009|NCT03118297|Secondary|Ovulation Status Measured by Weekly Serum Progesterone Levels|To evaluate effect, if any, of ulipristal acetate on ovulation status. Data in the table represent the lowest and highest values that were recorded over all of the measurements for each arm as a whole.|Baseline, weeks 1, 2, 3, 4|See baseline characteristics|||ng/mL|||Number
2538010|NCT03118297|Secondary|Number of Participants With Medication Side Effects by 30 Days|To evaluate participant satisfaction with regards to medication side effects.|30 days|See baseline characteristics|||participants|||Number
2538011|NCT03118297|Secondary|Participant Satisfaction With Bleeding Pattern at 30 Days|To evaluate participant satisfaction with regards to bleeding pattern after use of ulipristal acetate.|30 days|See baseline characteristics|||Participants|||Count of Participants
2538012|NCT03118297|Secondary|Number of Participants With Bleeding Cessation by Day 10|To evaluate bleeding cessation rates by day 10 following seven days of treatment with either ulipristal acetate or placebo.|10 days|See baseline characteristics|||Participants|||Count of Participants
2538013|NCT03118297|Primary|Number of Bleeding/Spotting Days With Use of Ulipristal Acetate as Measured by Daily Bleeding Diaries|To evaluate the effectiveness of ulipristal acetate (15mg) in decreasing bleeding/spotting days due to the ENG implant over a 30-day period as compared to placebo.|30 days|See baseline characteristics|||days||Inter-Quartile Range|Median
2538014|NCT03117569|Other Pre-specified|Provider Acceptability of Simplified Monitoring Strategy (Exploratory Outcome)|Provider acceptability of simplified monitoring strategy measured by study specific questionnaire completed by each site Principal Investigator and the primary Research Nurse.|12 weeks post end of treatment (SVR12)||||Participants|||Count of Participants
2538015|NCT03117569|Other Pre-specified|Severe/Life Threatening Adverse Events (Safety Outcome)|Proportion of patients with at least one severe or potentially life threatening (grade 3 or 4) adverse event.|12 weeks post end of treatment (SVR12)|ITT|||participants|||Number
2538016|NCT03117569|Other Pre-specified|Common Adverse Events (Safety Outcome)|Proportion of patients with common adverse events (reported in greater than 5%).|12 weeks post end of treatment (SVR12)|ITT|||participants|||Number
2538017|NCT03117569|Secondary|Patient Treatment Satisfaction|Patient was satisfied with their treatment follow-up plan.|12 weeks post end of treatment (SVR12)|ITT population|||Participants|||Count of Participants
2538105|NCT03111316|Primary|The Median Times From Placement of Foley Catheter to Vaginal Delivery|median time estimation for use of dinoprostone and foley catheter and foley catheter alone|48 hours||||hours||Inter-Quartile Range|Median
2538018|NCT03117569|Secondary|Number of Virological Failure Participants With NS3 and NS5A Polymorphisms at Baseline and Post-treatment Week 12|"Distribution of baseline resistance associated substitutions (RAS) in participants with virological failures. Baseline polymorphisms were detected by Sanger sequencing at the following amino acid positions:~NS3: 36, 56, 80, 155, 156, 166, 168 NS5A: 24, 28, 30, 31, 58, 93"|Baseline and 12 weeks post-treatment|Number of participants in the ITT population with virological failure (detectable HCV RNA)|||Participants|||Count of Participants
2538019|NCT03117569|Secondary|Health-related Quality of Life|Change in health-related quality of life score pre and post-treatment (measured by EQ-5D-3L). The EQ visual analogue scale records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' (value of 100) and 'Worst imaginable health state' (value of 0). The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement. Higher scores indicate better outcomes.|Screening and 12 weeks post end of treatment (SVR12)||||score on a scale||Full Range|Median
2538020|NCT03117569|Secondary|Treatment and Study Visits Adherence|Number adherent to treatment and study visits (on-treatment adherence and early treatment discontinuation).|12 weeks post end of treatment (SVR12)|ITT|||Participants|||Count of Participants
2538021|NCT03117569|Secondary|Undetectable HCV RNA (mITT Population)|Number of participants with undetectable HCV RNA based on mITT population.|12 weeks post end of treatment (SVR12)|The mITT population wexcludes patients who have completed treatment (>95% adherence) (according to phone contact at week 8), but have not returned for their SVR12 assessment.|||Participants|||Count of Participants
2538022|NCT03117569|Primary|Undetectable HCV RNA (ITT Population)|Number of participants with undetectable HCV RNA based on ITT population.|12 weeks post end of treatment (SVR12)|ITT|||Participants|||Count of Participants
2538023|NCT03117517|Secondary|Insulin Resistance|Insulin resistance was measure by calculating HOMA-IR from the data of insulin and sugar levels.|Baseline and after 3 months|Insulin resistance was determined by HOMA-IR|||unitless||Standard Deviation|Mean
2538024|NCT03117517|Secondary|Hormonal Profiles|Serum level of LH was measure at baseline and after 3 months of treatment|Baseine and after 3 Months|Serum LH level at basline|||mIU/ml||95% Confidence Interval|Geometric Mean
2538025|NCT03117517|Primary|Cytokines and Chemokines Measurements|IL-6 and IL-8 levels by ELISA method using commercially available kits.|Baseline and after 3 Months|Measurement of IL-6 levels in serum samples at baseline and after 3 months of treatment|||pg/ml||95% Confidence Interval|Geometric Mean
2538026|NCT03117140|Other Pre-specified|Surgical Length|Surgical length was recorded|Post op Day 0 (Baseline)||||minutes||Inter-Quartile Range|Median
2538027|NCT03117140|Other Pre-specified|Surgical Position|Surgical position was recorded|Post-op Day 0 (Baseline)||||Participants|||Count of Participants
2538028|NCT03117140|Secondary|Number of Patients Reporting Itching at Home|Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.|1-3 days||||Participants|||Count of Participants
2538029|NCT03117140|Secondary|Number of Patients Reporting Itching in the PACU|Patients itching was assessed post-op in the PACU.|Post-op day 0 (baseline)|1 patient in the Ropivacaine and Buprenorphine group did not obtain data on the itching in the PACU therefore was not included in the analysis|||Participants|||Count of Participants
2538030|NCT03117140|Secondary|Pain Score Reported by Patients at First Phone Call|Patients are called 1-3 days post-operatively to assess pain. Pain score is 0-10 scale with 0 is no pain and 10 is most severe pain.|Day 1-3||||units on a scale||Inter-Quartile Range|Median
2538031|NCT03117140|Secondary|Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area|Blood pressure changes in Second Stage Recovery Area for patients was looked at|Post-op Day 0 (baseline)|1 patient in Ropivacaine and Buprenorphine group did not have blood pressure data obtained in the second stage area so therefore was not included in the analysis|||Participants|||Count of Participants
2538032|NCT03117140|Secondary|Number of Patients With Blood Pressure (BP) Changes in the PACU|Blood pressure changes in PACU (Post-Anesthesia Care Unit) for patients was looked at|Post-op Day 0 (baseline)|1 patient in Ropivacaine and Buprenorphine group did get data for the BP changes in the PACU for the study so therefore was not included in the analysis|||Participants|||Count of Participants
2538033|NCT03117140|Secondary|Motor Duration of Block|Patients are called 1-3 days post-operatively to assess when motor component of their nerve block wore off|Day 1-3||||minutes||Inter-Quartile Range|Median
2538034|NCT03117140|Secondary|Number of Patients Reporting Nausea in the PACU|PACU (Post-Anesthesia Care Unit) assessment of nausea|Post-op day 0 (Baseline)||||Participants|||Count of Participants
2538035|NCT03117140|Secondary|Number of Patients Reporting Nausea at Home|Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.|1-3 days|1 patient in the Plain Ropivacaine group and the Ropivacaine and Buprenorphine group did not complete the survey about nausea at home and therefore was not included in the analysis|||Participants|||Count of Participants
2538036|NCT03117140|Secondary|Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit)|Vomiting in PACU (Post-Anesthesia Care Unit) for patients was looked at|Post-op Day 0 (Baseline)||||Participants|||Count of Participants
2538037|NCT03117140|Secondary|Patient Reporting Vomiting at Home|Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.|1-3 days|1 patient in the Plain Ropivacaine group and the Ropivacaine and Buprenorphine group did not complete the survey about vomiting at home and therefore was not included in the analysis|||Participants|||Count of Participants
2538038|NCT03117140|Secondary|Sensory Duration of Block|Patients are called 1-3 days post-operatively to assess when the sensory component of their nerve block wore off|Day 1-3||||minutes||Inter-Quartile Range|Median
2538039|NCT03117140|Secondary|Block Set up Time|Patients are assessed from needle removal to when they are no longer able to feel cold on the blocked extremity|Day one||||minutes||Inter-Quartile Range|Median
2538042|NCT03116841|Secondary|Changes From Start of Administration (Week 0) in Actigraph-Measured Number of Nocturnal Awakenings at Week 4, and End of Study|Actigraph is a small device usually that records the activity level of the body by sensing physical movement and that is used especially to measure the amount and quality of sleep. Mean value from the past 7 days at each time point was used for calculation. Reported data were individual times for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).|Week 4 and End of study (up to Week 8)|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Nocturnal awakenings|||Number
2538043|NCT03116841|Secondary|Changes From Start of Administration (Week 0) in Actigraph-Measured Sleep Latency at Week 4, and End of Study|Actigraph is a small device usually that records the activity level of the body by sensing physical movement and that is used especially to measure the amount and quality of sleep. Reported data were individual values for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).|Week 4 and End of study (up to Week 8)|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Minutes|||Number
2538044|NCT03116841|Secondary|Percent Changes From Start of Administration (Week 0) in Actigraph-Measured Sleep Efficiency at Week 4, and End of Study|Actigraph is a small device usually that records the activity level of the body by sensing physical movement and that is used especially to measure the amount and quality of sleep. Mean value from the past 7 days at each time point was used for calculation. Reported data were individual values for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).|Week 4 and End of study (up to Week 8)|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Percent of Change|||Number
2538045|NCT03116841|Secondary|Number of Nocturnal Awakenings Assessed by a Question at Week 4, and End of Study|"Number of nocturnal awakenings was assessed by a question about nocturnal awakenings, How Many Times Wake Up? which was asked to each participants by investigator. Reported data were individual times for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants)."|Week 4 and End of study (up to Week 8)|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Nocturnal awakenings|||Number
2538046|NCT03116841|Secondary|Changes From Start of Administration (Week 0) in C7: Daytime Dysfunction of PSQI Global Score at Week 4 and End of Study|PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).|Week 0, Week 4 and End of study (up to Week 8)|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Scores on a Scale|||Number
2538047|NCT03116841|Secondary|Changes From Start of Administration (Week 0) in C5: Sleep Disturbance of PSQI Global Score at Week 4 and End of Study|PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).|Week 0, Week 4 and End of study (up to Week 8)|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Scores on a Scale|||Number
2538048|NCT03116841|Secondary|Changes From Start of Administration (Week 0) in C4: Sleep Efficiency of PSQI Global Score at Week 4 and End of Study|PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).|Week 0, Week 4 and End of study (up to Week 8)|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Scores on a Scale|||Number
2538049|NCT03116841|Secondary|Changes From Start of Administration (Week 0) in C3: Sleep Duration of PSQI Global Score at Week 4 and End of Study|PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).|Week 0, Week 4 and End of study (up to Week 8)|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Scores on a Scale|||Number
2538050|NCT03116841|Secondary|Changes From Start of Administration (Week 0) in C2: Sleep Latency of PSQI Global Score at Week 4 and End of Study|PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).|Week 0, Week 4 and End of study (up to Week 8)|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Scores on a Scale|||Number
2538051|NCT03116841|Secondary|Changes From Start of Administration (Week 0) in C1: Sleep Quality of PSQI Global Score at Week 4 and End of Study|PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).|Week 0, Week 4 and End of study (up to Week 8)|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Scores on a Scale|||Number
2538052|NCT03116841|Secondary|Percentage of Participants With PSQI Global Score <6.0 at Week 4 and End of Study|PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality.|Week 4 and End of study (up to Week 8)|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Percentage of Participants|||Number
2538053|NCT03116841|Secondary|Changes From Start of Administration (Week 0) in PSQI Global Score at Week 4|PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality. Reported data were individual scores for each participants (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).|From Week 0 to Week 4|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Scores on a Scale|||Number
2538054|NCT03116841|Primary|Changes From Start of Administration (Week 0) in Pittsburgh Sleep Quality Index (PSQI) Global Score at End of Study|PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. Higher scores are representing worse sleep quality. Reported data were individual scores for each participant (Participant A to C) since descriptive statistics value was not calculated due to small size population (totally 3 participants).|Week 0 to End of study (up to Week 8)|Full Analysis Set (FAS): All participants who received at least 1 dose of the study drug for the treatment period.|||Scores on a Scale|||Number
2538055|NCT03116698|Secondary|Proportion of Subjects With Partial Clearance at Week 16|Proportion of subjects with partial clearance of AK lesions at week 16 (12 weeks treatment and 4 weeks treatment free follow up period)|16 weeks|ITT Population|||Participants|||Count of Participants
2538056|NCT03116698|Primary|Proportion of Subjects With Complete Clearance of AK Lesions at the End of Study Visit at 16 Weeks|The proportion of subjects with complete clearance (absence of clinically visible or palpable AK lesions in the treatment area) of AK lesions at the End of Study Visit at 16 weeks (12 weeks treatment and 4 weeks treatment-free follow-up)|16 Weeks|Intent To Treat (ITT) population defined as all subjects who were randomized and dispensed study medication.|||Participants|||Count of Participants
2538057|NCT03115853|Secondary|Difference in Mean Plasma Peak Aldosterone Levels||baseline to 18 weeks|data was lost and results are unknown||||||
2538058|NCT03115853|Secondary|Difference in Mean Changes in Plasma Renin Activity.||baseline to 18 weeks|||||||
2538059|NCT03115853|Secondary|Difference in Mean Plasma Aldosterone Levels||baseline to 18 weeks|||||||
2538060|NCT03115853|Primary|Difference in Mean Plasma PAI-1 Level||baseline to 18 weeks|data was lost and results are unknown||||||
2538061|NCT03115853|Primary|Difference in Peak Plasma PAI-1 Level||baseline to 18 weeks|data was lost and results are unknown||||||
2538062|NCT03115827|Secondary|Change in Stop-Signal Reaction Time From Baseline to Week 7|The Stop-Signal reaction time is a computerized test that assesses reaction time and response inhibition|baseline and week 7||||change in SSRT in seconds||Standard Deviation|Mean
2538063|NCT03115827|Secondary|Percent Compliance|Percent compliance is defined as the percent of study participants who take greater than or equal to 70% of the assigned dosage|7 weeks||||Participants|||Count of Participants
2538064|NCT03115827|Secondary|Maximum Tolerated Dose|The mean maximum tolerated dose of droxidopa reached by the study participants|Week 4 to Week 7||||mg/day||Standard Deviation|Mean
2538065|NCT03115827|Primary|Number of Participants Who Discontinue the Study Drug Due to Adverse Effects During the 7-week Treatment Period.|Tolerability will be defined by the number of patients who discontinue the study drug due to adverse effects.|7 weeks||||Participants|||Count of Participants
2538066|NCT03115827|Primary|Number of Subjects Who Develop an Adverse Event During the 7-week Treatment Period That is Determined to be Likely Related to the Study Medications.|Safety will be defined by the percent of subjects who develop an adverse event during the 7-week treatment period that is determined to be likely related to the study medications.|7 weeks||||Participants|||Count of Participants
2538067|NCT03115476|Secondary|Time to First Squamous Cell Carcinoma (SCC) or Other Skin Neoplasia in the Treatment Area|"Time to first squamous cell carcinoma (SCC) or other skin neoplasia in the treatment area. Relative difference between groups (ingenol disoxate vs vehicle) expressed as hazard ratio.~The indicated measured values are the observed incidence rates of the SCC in the treatment area which form the basis of the statistical analysis of the time to event analysis"|From Visit 2 (6 months after Month 14 of main trial) to first SCC or other skin neoplasia in the treatment area, up to 24 months|Full Analysis Set: 1234 subjects who were randomised and applied IMP in one of 4 Main Trials|||SCC events per 100 patient years||95% Confidence Interval|Number
2538120|NCT03110159|Primary|Time to Occurrence of NMSC in Recently Transplanted Solid Organ Recipient|Time to occurrence of NMSC will be calculated from the first visit to the development of an NMSC in the treatment areas and in the control areas.|3 Years|Patient consented but did not being treatment; PI terminated study.||||||
2538068|NCT03115476|Primary|Time to First Squamous Cell Carcinoma (SCC) in the Treatment Area|"Time to first squamous cell carcinoma (SCC) in the treatment area. Relative difference between groups (ingenol disoxate vs vehicle) expressed as hazard ratio.~The indicated measured values are the observed incidence rates of the SCC in the treatment area which form the basis of the statistical analysis of the time to event analysis"|From Visit 2 (6 months after Month 14 of main trial) to first SCC in the treatment area, up to 24 months|Full Analysis Set: 1234 subjects who were randomised and applied IMP in one of 4 Main Trials|||SCC events per 100 patient years||95% Confidence Interval|Number
2538069|NCT03115411|Primary|Count of Participants With Stent Patency at 90 Days|Evaluation of laboratory studies and clinical status to assess for stent patency/evidence of biliary obstruction|90 days after placement of stent|Patients with biliary obstruction (non-malignant) who underwent ERCP with placement of winged biliary stent.|||Participants|||Count of Participants
2538070|NCT03115177|Primary|Bacterial Culture|Intraoperative cultures will be taken from all study participants and tested for detection of bacteria. These cultures were held for 14 days and tested for aerobic and anaerobic bacteria. Reported data are presented for the number of participants with a positive bacteria culture from the intraoperative samples.|2 weeks||||# Participants with Bacteria in Culture|||Number
2538071|NCT03114995|Secondary|Percentage of Participants With Periprocedural Myonecrosis|"Percentage of participants with periprocedural myonecrosis under the criteria described below.~When the cardiac biomarkers before the procedure were within the 99th percentile upper reference limit (URL), more than a 5-fold elevation in the URL within 12 hours after percutaneous coronary intervention (PCI) was defined as periprocedural myonecrosis. If the cardiac biomarker level was already above the 99th percentile URL before the procedure and the trend was stationary or decreasing, a ≥20% increase compared to the previous level was considered periprocedural myonecrosis. If the trend was still increasing, the levels at the post-6 hour and 12-hour were compared to determine periprocedural myonecrosis."|0,6,12,18,24,30,36 hours||||Participants|||Count of Participants
2538072|NCT03114995|Primary|Area Under Curve of Serial Cardiac Biomarkers|An area under the curve of serial levels of Troponin I and creatine kinase-MB isoenzyme during 36 hours|0,6,12,18,24,30,36 hours||||Hours*ng/ml||Inter-Quartile Range|Median
2538073|NCT03114969|Secondary|Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI)|"Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP."|Week 6|ITT Population. Only those participants with data available at Visit 2 were analyzed.|||Percentage of participants|||Number
2538074|NCT03114969|Secondary|Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)|Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on correct use of inhalers. Any error made by the participant was recorded by HCP in the checklist. Checklist of instructions for correct use were based on steps for correct use listed in PILs for the respective DPI. Errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per PIL. Overall errors is the combination of critical and non-critical errors. Percentage of participants making at least one overall error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP.|Week 6|ITT Population. Only those participants with data available at Visit 2 were analyzed.|||Percentage of participants|||Number
2538075|NCT03114969|Secondary|Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA)|"Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making at least one overall error in either one or both devices (where applicable) is presented."|Week 6|ITT Population. Only those participants with data available at Visit 2 were analyzed.|||Percentage of participants|||Number
2538076|NCT03114969|Secondary|Percentage of Participants Making at Least One Overall Error at Visit 2 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI|"Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps listed in PILs for the respective DPI. The errors were defined as critical, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making at least one overall error in primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.~."|Week 6|ITT Population. Only those participants with data available at Visit 2 were analyzed.|||Percentage of participants|||Number
2538077|NCT03114969|Secondary|Percentage of Participants Making at Least One Overall Error at Visit 2 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)|"Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps listed in PILs for the respective DPI. The errors were defined as critical, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making at least one overall error in primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP."|Week 6|ITT Population. Only those participants with data available at Visit 2 were analyzed.|||Percentage of participants|||Number
2538078|NCT03114969|Secondary|Percentage of Participants Making at Least One Overall Error at Visit 2-Primary Device Comparisons|"Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making at least one overall error in the primary DPI is presented."|Week 6|ITT Population. Only those participants with data available at Visit 2 were analyzed.|||Percentage of participants|||Number
2538079|NCT03114969|Secondary|Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI)|"Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP."|Week 6|ITT Population. Only those participants with data available at Visit 2 were analyzed.|||Percentage of participants|||Number
2538080|NCT03114969|Secondary|Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)|"Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP."|Week 6|ITT Population. Only those participants with data available at Visit 2 were analyzed.|||Percentage of participants|||Number
2538081|NCT03114969|Secondary|Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA)|"Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented."|Week 6|ITT Population. Only those participants with data available at Visit 2 were analyzed.|||Percentage of participants|||Number
2538082|NCT03114969|Secondary|Percentage of Participants Making at Least One Critical Error at Visit 2 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI|"Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors during demonstration by participants were defined as critical, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP."|Week 6|ITT Population. Only those participants with data available at Visit 2 were analyzed.|||Percentage of participants|||Number
2538090|NCT03114969|Secondary|Percentage of Participants Making at Least One Overall Error at Visit 1-Primary Device Comparisons|"Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants with at least one overall error in the primary DPI is presented."|Day 1|ITT Population|||Percentage of participants|||Number
2538083|NCT03114969|Secondary|Percentage of Participants Making at Least One Critical Error at Visit 2 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)|"Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP."|Week 6|ITT Population. Only those participants with data available at Visit 2 were analyzed.|||Percentage of participants|||Number
2538084|NCT03114969|Secondary|Percentage of Participants Making at Least One Critical Error at Visit 2-Primary Device Comparisons|"Participants were asked to demonstrate use of their prescribed DPI at Visit 2 within 6 weeks after they were retrained on the correct use of inhalers. Any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented."|Week 6|ITT Population. Only those participants with data available at Visit 2 were analyzed.|||Percentage of participants|||Number
2538085|NCT03114969|Secondary|Percentage of Participants Making at Least One Overall Error at Visit 1-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI)|"Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. Errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. Percentage of participants making at least one overall error in either one or both devices (where applicable) is presented.The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP."|Day 1|ITT Population|||Percentage of participants|||Number
2538086|NCT03114969|Secondary|Percentage of Participants Making at Least One Overall Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)|"Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. Errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. Percentage of participants making at least one overall error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP."|Day 1|ITT Population|||Percentage of participants|||Number
2538087|NCT03114969|Secondary|Percentage of Participants Making at Least One Overall Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA)|"Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants making at least one overall error in either one or both devices (where applicable) is presented."|Day 1|ITT Population|||Percentage of participants|||Number
2538088|NCT03114969|Secondary|Percentage of Participants Making at Least One Overall Error at Visit 1 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI|"Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants with at least one overall error in primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP."|Day 1|ITT Population|||Percentage of participants|||Number
2538089|NCT03114969|Secondary|Percentage of Participants Making at Least One Overall Error at Visit 1 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)|"Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose and non-critical when the dose may not be affected, but the participant has demonstrated improper use of their DPI, as per the PIL. Overall errors is the combination of critical and non-critical errors. The percentage of participants with at least one overall error in primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one overall error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP."|Day 1|ITT Population|||Percentage of participants|||Number
2538091|NCT03114969|Primary|Percentage of Participants Making at Least One Critical Error at Visit 1-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI)|"Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP."|Day 1|ITT Population|||Percentage of participants|||Number
2538092|NCT03114969|Primary|Percentage of Participants Making at Least One Critical Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)|"Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP."|Day 1|ITT Population|||Percentage of participants|||Number
2538093|NCT03114969|Primary|Percentage of Participants Making at Least One Critical Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA)|"Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented."|Day 1|ITT Population|||Percentage of participants|||Number
2538094|NCT03114969|Primary|Percentage of Participants Making at Least One Critical Error at Visit 1 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI|"Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP."|Day 1|ITT Population|||Percentage of participants|||Number
2538095|NCT03114969|Primary|Percentage of Participants Making at Least One Critical Error at Visit 1 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI)|"Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the HCP in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and reporting and analysis plan (RAP)."|Day 1|ITT Population|||Percentage of participants|||Number
2538096|NCT03114969|Primary|Percentage of Participants Making at Least One Critical Error at Visit 1-Primary Device Comparisons|"Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the health care practitioner (HCP) in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in patient instruction leaflets (PILs) for the respective DPI. The errors made during demonstration by participants were defined as critical, when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The analysis was performed on the Intent to Treat (ITT) Population which comprised of all enrolled participants who demonstrated use of their primary DPI."|Day 1|ITT Population|||Percentage of participants|||Number
2538097|NCT03114488|Primary|Change in Amplitude of N100 Component of the Auditory Evoked Potential|The amplitude of the N100 component will be averaged across individuals in each group. Grand averages from the two groups will be compared. Outcome is reported as the change from baseline to post-treatment (approximately 1 hour).|approximately 1 hour||||microvolts||Standard Deviation|Mean
2538098|NCT03113656|Primary|Change in Finnegan Score|Finnegan scale measures signs of neonatal drug withdrawal syndrome. It provides a summative score obtained from the assessment of 21 items related to neonatal withdrawal. The total score ranges from 0 to 43 with a higher score indicating more severe symptoms. Values above 8 have been described as being indicative of neonatal abstinence syndrome.|baseline and 30 minutes|"Reporting Arms/Groups per intervention"|||score on a scale||Standard Deviation|Mean
2538099|NCT03112993|Other Pre-specified|Difference in Time to First Ambulation After Surgery|Time from end of anesthesia to the first subject ambulation in hours.|From Day 1 up to 1 week, depending on individual recovery time||||hours||Standard Deviation|Mean
2538100|NCT03112993|Secondary|Difference in Length of Stay in PACU|Length of PACU stay measured in minutes.|Day 1||||minutes||Standard Deviation|Mean
2538101|NCT03112993|Secondary|Difference in Time From Neuromuscular Reversal to Tracheal Extubation|Difference in time from neuromuscular reversal to tracheal extubation was measured in minutes.|Day 1||||minutes||Standard Deviation|Mean
2538102|NCT03112993|Primary|Difference in Time From Neuromuscular Reversal to Exit From OR|Difference in time from neuromuscular reversal to exit from OR was measured in minutes.|Day 1||||minutes||Standard Deviation|Mean
2538106|NCT03111108|Secondary|Prevalence of Baseline NS5A RASs to EBR or GZR|Blood samples for viral resistance assays were collected at Baseline (Day 1) and analyzed for substitutions in the NS5A gene region. Results are pooled for all participants with baseline sequencing data available, and the number of participants with RASs is reported according HCV genotype. Resistance-associated substitutions are defined as amino acid substitutions that confer reduced susceptibility to a DAA and may contribute to virologic failure. The prevalence of baseline substitutions in participants infected with HCV GT4 subtypes was assessed by evaluating amino acid substitutions in NS5A.|Day 1|All randomized participants with baseline sequencing data for NS5A are included.|||Participants|||Number
2538107|NCT03111108|Secondary|Prevalence of Baseline NS3 Resistance-Associated Substitutions (RASs) to EBR or GZR|Blood samples for viral resistance assays were collected at Baseline (Day 1) and analyzed for substitutions in the NS3 gene region. Results are pooled for all participants with baseline sequencing data available, and the number of participants with RASs is reported according HCV genotype. Resistance-associated substitutions are defined as amino acid substitutions that confer reduced susceptibility to a direct-acting antiviral (DAA) and may contribute to virologic failure. The prevalence of baseline substitutions in participants infected with HCV GT4 subtypes was assessed by evaluating amino acid substitutions in NS3.|Day 1|All randomized participants with baseline sequencing data for NS3 are included.|||Participants|||Number
2538108|NCT03111108|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After End of Treatment (SVR24)|The percentage of participants to achieve SVR24 was determined for each arm (SVR24 was defined as HCV RNA < LLOQ at 24 weeks after the end of all study therapy). Plasma HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ TaqMan HCV Test, v2.0®, which has a LLOQ of 15 IU/mL.|24 weeks after completing study treatment (Arm 1: Week 32 / Arm 2: Week 36)|All randomized participants who received ≥1 dose of study treatment are included.|||Percentage of Participants||95% Confidence Interval|Number
2538109|NCT03111108|Primary|Number of Participants Who Discontinued From Study Treatment Due to an AE|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Study Week 12|All randomized participants who received ≥1 dose of study treatment are included, classified according to treatment duration actually received.|||Participants|||Number
2538110|NCT03111108|Primary|Number of Participants With ≥ 1 Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 weeks|All randomized participants who received ≥1 dose of study treatment are included, classified according to treatment duration actually received.|||Participants|||Number
2538111|NCT03111108|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After End of Treatment (SVR12)|The percentage of participants to achieve SVR12 was determined for each arm (SVR12 was defined as HCV ribonucleic acid [RNA] < lower limit of quantification [LLOQ] at 12 weeks after the end of all study therapy). Plasma HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ TaqMan HCV Test, v2.0®, which has a LLOQ of 15 IU/mL.|12 weeks after completing study treatment (Arm 1: Week 20 / Arm 2: Week 24)|All randomized participants who received ≥1 dose of study treatment are included.|||Percentage of Participants||95% Confidence Interval|Number
2538112|NCT03110900|Primary|Number of Subjects Reporting Reduction of Agitation on Positive and Negative Syndrome Scale (PANSS)|Change in agitation level on the PANSS from baseline up to 120 minutes -- terminated by sponsor before results available|120 minutes|No data was collected because the sponsor terminated the study before any data could be collected.||||||
2538113|NCT03110692|Primary|Percent of Patients Receiving Daily Imaging|Radiology tests including x-rays and CT scans|3 months post arm crossover||||Participants|||Count of Participants
2538114|NCT03110601|Primary|Change in Pain Relative to Baseline and After a Trial Period|Numerical rating pain score measured before and after intervention. 11-point Numeric Pain Rating Scale (NPRS) with 0 being no pain at all and 10 being the worst pain imaginable (1-3 is rated as mild pain, 4-6 is rated at moderate pain, 7-9 is rated as severe pain). Subject rates average pain for the past 7 days.|Baseline and 4 days plus or minus 1 days|Chronic Back Pain Patients with or without leg pain; 4 subjects experience known adverse events (such as lead migration) that prevented them from testing Stimgenics SCS.|||Score on a 11 point scale||Standard Deviation|Mean
2538115|NCT03110380|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||cells/µL||Standard Deviation|Mean
2538116|NCT03110380|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2538117|NCT03110380|Primary|Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2538118|NCT03110159|Secondary|The Number of Participants With Treatment Related Adverse Events as Assessed by the CTCAE v4.0|The number of evaluable study participants who had a grade 3 or higher adverse event (AE) or any serious adverse event that's determined to be at least possibly or probably related to study treatment, or any AE which is at least possibly or probably related to study treatment that causes permanent study discontinuation.|3 Years|Patient consented but did not being treatment; PI terminated study.||||||
2538119|NCT03110159|Secondary|Pain Control With Levulan-PDT in Solid Organ Transplant Recipient|Pain will be assessed on the 10 point Visual Analogue Scale (VAS), as mild (0-3), moderate (4-7) or severe (8-10). Patients will be asked to rate the pain at the beginning, midway point (approximately 8 minutes later), and at the end of each PDT session.|Day 1, Day 30, Day 180, 12 months, 18 months, 24 months, 30 months, 36 months|Patient consented but did not being treatment; PI terminated study.||||||
2538121|NCT03110159|Primary|Primary Prevention of NMSC in Recently Transplanted Solid Organ Recipient|Number of NMSC will be counted for each site using the photographs of the treatment and the control areas. NMSC, including basal cell carcinoma, Bowen's disease and squamous cell carcinoma, will be diagnosis and confirmed histologically by biopsy.|3 Years|Patient consented but did not being treatment; PI terminated study.||||||
2538122|NCT03110159|Primary|Time to Occurrence of AKs in Recently Transplanted Solid Organ Recipient|Time to occurrence of AK will be calculated from the first visit to the development of an AK in the treatment areas and in the control areas.|3 Years|Patient consented but did not being treatment; PI terminated study.||||||
2538123|NCT03110159|Primary|Primary Prevention of AKs in Recently Transplanted Solid Organ Recipient|Number of AK will be counted for each site using the photographs of the treatment and the control areas. AKs will be graded by thickness.|3 Years|Patient consented but did not begin treatment; PI terminated study.||||||
2538124|NCT03110029|Secondary|Percentage of Disease Improvement Using Onychomycosis Severity Index (OSI)|Using 3rd party blinding, DLSO was assessed at baseline and at every subsequent visit using the onychomycosis severity index (OSI), measuring percent of the target nail involved, and grading the infection from mild to moderate to severe. The range for OSI is 0-20 with 20 indicating severe nails disease. Nail growth was measured at each visit. Fungal testing was done at screening, 3 months, 7 months, end of treatment (48 weeks), and end of study (52 weeks). Clinical and mycologic cure was evaluated at week 52.|52 week|We did not include results from the two participants who withdrew from the study due to personal scheduling conflicts. Results for only 11 subjects who completed the study are represented in the number of participants analyzed.|||percentage change target nail||Full Range|Mean
2538125|NCT03110029|Primary|Percentage of Nail Polish Disruption Using the Likert Scale|"Patients will answer the following question:~Which will be answered using a Likert scale where 0 represents no alteration in polish and 10 represents complete destruction of the polish:~Is the quality of your polish diminished with use of Jublia?"|52 weeks|Only participants who completed the trial were included in results. Two participants withdrew due to personal scheduling conflicts.|||percentage of nail polish disruption||Full Range|Mean
2538126|NCT03110003|Secondary|Patient Satisfaction as Determined by a Likert-type Scale|"Patient satisfaction of a scale of 1-10~This scale is grade from 1 to 10 with 1 being highly dissatisfied with the anesthetic technique and 10 being highly satisfied. Each patient was asked to rate their experience with the anesthetic technique provide. They could choose any number between 1 and 10. Numbers close to 10 represented a higher satisfaction with the anesthetic technique."|At 6 hrs postoperatively|Patient satisfaction as determined by a Likert-type scale was not collected by the investigators.||||||
2538127|NCT03110003|Secondary|Quality of Block as Determined by Subjective Pain Assessment|Determined by any pain reported during surgery and/or the need to supplement through the epidural|Baseline up to 6 hours|Quality of Block as determined by subjective pain assessment was not collected by the investigators.||||||
2538128|NCT03110003|Secondary|Time Elapsed Until Motor Block Regresses to Modified Bromage Score = 0|"Time until score of <2 reached on Modified Bromage scale~This is simple scale used to assess motor function in the patients' legs. A numerical value from 0 to 4 is assigned to visual inspection of how well the patient can move her legs. 0=ability to maintain a leg lift for prolonged periods; 1=ability to lift legs briefly; 2=ability to bend knees; 3=ability to wiggle toes; 4=no movement in legs. A score of 0 means complete movement (no blockade) in the legs, whereas a score of 4 means no movement (complete blockade) in the legs. Once the patient received as score of 0, the time ended. Again, 0=ability to maintain a leg lift for prolonged periods."|Baseline up to 6 hours|Time elapsed until motor block regresses to modified Bromage = 0.|||Minutes||Inter-Quartile Range|Median
2538129|NCT03110003|Secondary|Degree of Peak Motor Blockade by Modified Bromage Scale|"Motor blockade will be determined by the patient's ability to lift her legs~This is simple scale used to assess motor function in the patients' legs. A numerical value from 0 to 4 is assigned to visual inspection of how well the patient can move her legs. 0=ability to maintain a leg lift for prolonged periods; 1=ability to lift legs briefly; 2=ability to bend knees; 3=ability to wiggle toes; 4=no movement in legs. A score of 0 means complete movement (no blockade) in the legs, whereas a score of 4 means no movement (complete blockade) in the legs."|Baseline up to 3 hours||||score on a scale||Inter-Quartile Range|Mean
2538130|NCT03110003|Secondary|Peak Block Height|Thoracic dermatome level as assessed by pinprick|Baseline up to 3 hours|Thoracic dermatome level as assessed by pinprick|||Thoracic dermatome||Inter-Quartile Range|Median
2538131|NCT03110003|Primary|Time Until PACU Discharge in Minutes|Time from entrance into the PACU until PACU discharge criteria met|Baseline up to 48 hrs postoperatively||||minutes||Full Range|Median
2538132|NCT03109951|Secondary|Number of Participants With Self-treatment and Relief of Hypoglycemic Symptoms|Discover if self-treatment of hypoglycemic symptoms relieves hypoglycemia and associated symptoms|From colonoscopy preparation beginning to day 1 after colonoscopy|4 subjects reported hypoglycemia symptoms. All recovered through self-treatment (e.g. drinking juice or taking candy).|||Participants|||Count of Participants
2538133|NCT03109951|Secondary|Cognition of Hypoglycemic Symptoms|Subjects awareness of hypoglycemic symptoms - by questionnaire 96 subjects were aware of hypoglycemic symptoms and could recognize them.|30 minutes before colonoscopy||||Participants|||Count of Participants
2538134|NCT03109951|Primary|Abnormal Glucose Levels After Colonoscopic Preparation|Count of patients with Serum glucose levels < 70mg/dL or >250mg/dL|30 minutes before colonoscopy||||Participants|||Count of Participants
2538135|NCT03109873|Secondary|Incidence of Toxicities|Evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0|Up to 2 years|Due to insufficient accrual, statistical results cannot be reported.||||||
2538136|NCT03109873|Secondary|Exosome Profile|Longitudinal measurements of exosomes will also be modeled using mixed effects linear regression. This analysis is treated as separate from the cytokine questions and the p-value will not be adjusted.|Up to 1 year|Due to insufficient accrual, statistical results cannot be reported.||||||
2538137|NCT03109873|Secondary|Objective Response Rate|The objective response rate will be estimated by arm along with an exact 95% binomial confidence interval|Up to 2 years|Due to insufficient accrual, statistical results cannot be reported.||||||
2539489|NCT03070730|Secondary|Change in Physical Functioning-MFI From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Multidimensional Fatigue Inventory (MFI).|1 week after second intervention|||||||
2538138|NCT03109873|Secondary|Mucositis Assessed Using WHO Classification|Analysis will be primarily descriptive. The distribution of swallowing function and mucositis scores will be summarized by arm using means, medians, standard deviations, and ranges.|Up to 1 year|Due to insufficient accrual, statistical results cannot be reported.||||||
2538139|NCT03109873|Primary|Cytokine/Chemokine Profile|Mixed effects linear regression will be used to model longitudinal measurements of each cytokine.|Up to 1 year|Due to insufficient accrual, statistical results cannot be reported.||||||
2538140|NCT03109769|Primary|Change in Gingival Index|Gingival index: 0, normal gingiva, 1, mild inflammation - slight change in color, slight edema and no bleeding on probing, 2, moderate inflammation - redness, edema and glazing and bleeding on probing, 3, severe inflammation - marked redness and edema, ulceration and tendency to spontaneous bleeding.|At baseline and after 4 weeks.||||units on a scale||Standard Deviation|Mean
2538141|NCT03109769|Primary|Change in Plaque Index|Plaque index: 0, no plaque, 1, plaque seen on the tip of the explorer or with disclosing agent, 2. plaque seen with the naked eye, 3, abundance of plaque.|At baseline and after 4 weeks.||||units on a scale||Standard Deviation|Mean
2538142|NCT03109418|Secondary|Patient Satisfaction Score|Patients will rate their quality of anesthesia services|At 24 hrs post-op|Participants were not analyzed due to study being terminated. Data was not collected.||||||
2538143|NCT03109418|Primary|Pain Scores|Visual Analog Scale pain rating|up to 24 hours postoperatively|Study was terminated. Data was not collected.||||||
2538144|NCT03109184|Secondary|Change in Distress Tolerance From Baseline to 9 Months|The Behavioral Indicator of Resiliency to Distress (BIRD) is a 5-minute computerized distress tolerance task for adolescents. This measure generates a score of total time that adolescents persist on a frustrating task, which has been linked to distress tolerance. Scores are recorded in milliseconds (ms) with a maximum time participants can persist is 300 seconds (0-300 is the range). Higher score indicate longer persistence during the frustrating task.|Baseline, 3 months, 9 months|COMPLETER ANALYSIS|||seconds||Standard Deviation|Mean
2538145|NCT03109184|Secondary|Change in Emotion Regulation Skills Baseline to 9 Months|"The Emotion Regulation Behavioral Skills (ERBS) scale is comprised of 8 items rated on a scale of 1 all the time to 5 never and was specifically created for to detect the use of the specific affect management strategies taught in the Project STRONG intervention. Sample items include How often did you…get away from whatever was causing your feeling? …talk to someone about whatever was causing your feeling? Higher scores indicate greater use of emotion regulation skills."|Baseline, 3 months, 9 months|COMPLETER ANALYSIS|||score on a scale||Standard Deviation|Mean
2538146|NCT03109184|Secondary|Change in Parent-Adolescent Communication From Baseline to 9 Months|Parent Adolescent Communication Survey (PACS) is 20 item survey measuring quality of communication between adolescents and their parents. Adolescents will complete the measure in reference to the parent participating in the intervention with them. This is completed by parents and youth. This scale also produces two sub scales: The Open Family Communication Scale (OFCS) and The Problems in Family Communication Scale (PFCS). Item responses range from 1-5 with 1=Strongly disagree, 2=Moderately disagree, 3=Neither agree neither disagree, 4=Moderately agree, 5=Strongly agree. On the OFCS subscale, higher scores indicate more open communication. One the PFCS subscale, higher scores indicate fewer problems in family communication, thus higher scores on both subscales are favorable.|Baseline, 3 months, and 9 months|COMPLETER ANALYSIS|||score on a scale||Standard Deviation|Mean
2538147|NCT03109184|Secondary|Change in Emotion Regulation Skills From Baseline to 9 Months|The Adolescent Self-Regulatory Inventory (ASRI) is a 33 item survey that measures adolescents' use of both functional and dysfunctional emotion regulation strategies. It produces two sub scales measuring short-term and long-term self-regulation. Item responses range from 1-5 with 1= Not at all true for me, 2= Rarely true for me, 3= True some of the time, 4= True most of the time, 5= Really true for me. Items were reverse coded so that higher scores indicate more use of emotion regulation behaviors.|Baseline, 3 months, and 9 months|COMPLETER ANALYSIS|||score on a scale||Standard Deviation|Mean
2538148|NCT03109184|Primary|Change in Attitudes About Relationship Violence From Baseline to 9 Months|Adolescent Relationship Violence Questionnaire (ARVQ) is a 22-item questionnaire is a composite measure developed to assess changes in knowledge, attitudes, and methods of dealing with relationship violence. Item responses ranged from 1-4 with 1=strongly agree, 2=agree, 3=disagree 4=strongly disagree. Higher scores indicate more favorable attitudes.|Baseline, 3 months, and 9 months|COMPLETER ANALYSIS|||score on a scale||Standard Deviation|Mean
2538149|NCT03109184|Primary|Change in General Aggressive Behavior From Baseline to 9 Months|The Aggression Questionnaire (AQ) is a 34-item questionnaire that rates five types of aggression (physical aggression, verbal aggression, anger, hostility, and indirect aggression). Item responses ranged from 1-5, with 1=Not at all like me, 2=A little like me, 3=Somewhat like me, 4=Very much like me, 5=Completely like me. Higher scores indicate more aggression.|Baseline, 3 months, 9 months||||score on a scale||Standard Deviation|Mean
2538150|NCT03109184|Primary|Change in Dating Violence (DV) Perpetration From Baseline to 9 Months|The Conflict in Adolescent Dating Relationships Inventory (CADRI) is a behavioral measure of abuse perpetration and victimization. It was completed by teens in reference to conflict or disagreement with a current or recent dating partner. Each question is asked twice, first regarding perpetration and, again in relation to victimization producing a perpetration and a victimization sub scale. Percentages include teens endorsing any perpetration or victimization.|Baseline, 3 months, and 9 months|COMPLETER ANALYSIS|||Participants|||Count of Participants
2538151|NCT03108924|Secondary|[Parts 1 and 2] Number of Participants Discontinuing Study Treatment Due to an AE|The number of participants who discontinued study treatment due to an AE was assessed. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.|Part 1 and 2 - Up to 15 days|All participants in Parts 1 and 2 who received at least one dose of the study drug.|||Participants|||Count of Participants
2538413|NCT03100058|Secondary|Change From Baseline in High Sensitive C-reactive Protein (hsCRP)|Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48|Baseline to Week 24, Week 24 to Week 48 (Epoch 4)|Full Analysis Set|||mg/L||95% Confidence Interval|Geometric Mean
2538152|NCT03108924|Secondary|[Parts 1 and 2] Number of Participants Experiencing an Adverse Event (AE)|The number of participants who experienced at least one adverse event (AE) was assessed. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure.|Parts 1 and 2 - Up to 29 days.|All participants in Parts 1 and 2 who received at least one dose of the study drug.|||Participants|||Count of Participants
2538153|NCT03108924|Primary|[Parts 1 and 2] Estimated CLr of Gefapixant 50 mg in Participants With BSA Non-Normalized eGFR (Regression Analysis)|CLr values of plasma gefapixant based on BSA non-normalized eGFR for participants with moderate RI, severe RI, or normal renal function (i. e., Healthy Controls) were estimated using regression analysis. Individual values of CLr were natural log-transformed and evaluated with a linear fixed-effects model containing BSA non-normalized eGFR as a continuous variable. The back transformed mean AUC0-inf and corresponding 95% CI were predicted at the midpoint of the BSA non-normalized eGFR range for each group (45 mL/min, 22.5 mL/min, and 139 mL/min for moderate RI, severe RI, and healthy controls, respectively). Although no participants with mild RI were included in this study, their BSA non-normalized eGFR estimates were predicted at midpoint 75 mL/min.|Parts 1 and 2 - Predose and at 0-12 hrs, 12-24 hrs, and 24-48 hrs post dose|All participants in Parts 1 and 2 who were compliant with the study procedure and had available data were included. Renal clearance could not be assessed for ESRD participants. Participants originally assigned to the severe RI group were reassigned: 1 to the mild RI group (excluded from analysis), and 1 to the moderate RI group.|||L/hr||95% Confidence Interval|Mean
2538154|NCT03108924|Primary|[Parts 1 and 2] Estimated CLr of Gefapixant 50 mg in Participants With BSA-Normalized eGFR (Regression Analysis)|CLr values of plasma gefapixant based on BSA-normalized eGFR for participants with moderate RI, severe RI, or normal renal function (i. e., Healthy Controls) were estimated using regression analysis. Individual values of CLr were natural log-transformed and evaluated with a linear fixed-effects model containing BSA-normalized eGFR as a continuous variable. The back transformed mean CLr and corresponding 95% CI were predicted at the midpoint of the BSA-normalized eGFR range for each group (45 mL/min, 22.5 mL/min, and 139 mL/min for moderate RI, severe RI, and healthy controls, respectively). Although no participants with mild RI were included in this study, their normalized eGFR estimates were predicted at midpoint 75 mL/min.|Parts 1 and 2 - Predose and at 0-12 hrs, 12-24 hrs, and 24-48 hrs post dose|All participants in Parts 1 and 2 who were compliant with the study procedure and had available data were included. This population was used for regression analysis of the BSA-normalized CLr of gefapixant 50 mg. Renal clearance could not be assessed for participants with ESRD.|||L/hr||95% Confidence Interval|Mean
2538155|NCT03108924|Primary|[Parts 1 and 2] Estimated CLr of Gefapixant 50 mg in Participants With Moderate RI, Severe RI, or Normal Renal Function (Categorical Analysis)|Geometric mean and 95% CI for CLr were estimated in participants with moderate RI, severe RI, and normal renal function (i. e., Healthy Controls). Individual values of CLr, were ln-transformed and evaluated with a linear fixed-effects heterogeneous variance model containing a categorical effect for population (severe RI, moderate RI, and healthy matched control, based on BSA normalized eGFR). To compare subjects with RI in each of the renal categories to subjects with normal renal function, a two-sided 90% CI for the true difference in means (renal impairment - normal renal function) was calculated for CLr, using the mean square error from the model and referencing a t-distribution. For each of the RI populations, these confidence limits were exponentiated to obtain the 90% CI for the GMR (renal impairment/normal renal function).|Parts 1 and 2 - Predose and at 0-12 hrs, 12-24 hrs, and 24-48 hrs post dose|All participants in Parts 1 and 2 who were compliant with the study procedure and had available data were included. Renal clearance could not be assessed for participants with ESRD.|||L/hr||95% Confidence Interval|Geometric Least Squares Mean
2538156|NCT03108924|Primary|[Parts 1 and 2] Renal Clearance (CLr) of Gefapixant 50 mg|The renal clearance (CLr) in participants with moderate RI, severe RI, or normal renal function (i. e., Healthy Controls) was assessed. Non-model base summary statistics were provided. Renal clearance could not be assessed for participants with ESRD. Urine specimens were obtained by spot collection predose and at multiple timepoints postdose.|Parts 1 and 2 - Predose and at 0-12 hrs, 12-24 hrs, and 24-48 hrs post dose|All participants who were compliant with the study procedure and had available data were included. Renal clearance could not be assessed for participants with ESRD.|||L/hr||Standard Deviation|Mean
2538157|NCT03108924|Primary|[Parts 1 and 2] Estimated CL/F of Gefapixant 50 mg in Participants With Moderate RI, Severe RI, ESRD Non-HD, or Normal Renal Function (Categorical Analysis)|Geometric mean and 95% CI for CL/F were estimated in participants with moderate RI, severe RI, ESRD requiring but not receiving HD, and normal renal function (i. e., Healthy Controls). Individual values of CL/F, were ln-transformed and evaluated with a linear fixed-effects heterogeneous variance model containing a categorical effect for population (ESRD Non-HD, severe RI, moderate RI, and healthy matched control, based on BSA normalized eGFR). To compare subjects with RI in each of the renal categories to subjects with normal renal function, a two-sided 90% CI for the true difference in means (renal impairment - normal renal function) was calculated for CL/F, using the mean square error from the model and referencing a t-distribution. For each of the RI populations, these confidence limits were exponentiated to obtain the 90% CI for the GMR (renal impairment/normal renal function).|Parts 1 and 2 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All participants in Parts 1 and 2 who were compliant with the study procedure and had available data were included. A single participant with 6 missing plasma samples in Part 2, Period 1 was excluded from the ESRD Non-HD group.|||L/hr||95% Confidence Interval|Geometric Least Squares Mean
2538187|NCT03108027|Secondary|Peak Expiratory Flow (PEF)|Peak expiratory flow (PEF) is the maximum flow generated during a forceful exhalation, starting from full lung inflationDaily morning and evening peak expiratory flow rate from Day 2 to Day14 during the three treatment periods.|From treatment period start through study completion (up to 19 weeks).|The pharmacodynamic (PD) analysis set included all patients with any available PD data, who received any dose of study drug and experienced no protocol deviations with relevant impact on PD data|||L/min||Standard Error|Least Squares Mean
2545591|NCT02940327|Primary|CD16/41|Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.|72 hours after ECMO commencement||||percentage change||Standard Deviation|Mean
2538158|NCT03108924|Primary|[Part 1] Estimated CL/F of Gefapixant 50 mg in Participants With BSA Non-Normalized eGFR (Regression Analysis)|CL/F values of plasma gefapixant based on BSA non-normalized eGFR for participants with moderate RI, severe RI, or normal renal function (i. e., Healthy Controls) were estimated using regression analysis. Individual values of CL/F were natural log-transformed and evaluated with a linear fixed-effects model containing BSA non-normalized eGFR as a continuous variable. The back transformed mean CL/F and corresponding 95% CI were predicted at the midpoint of the BSA non-normalized eGFR range for each group (45 mL/min, 22.5 mL/min, and 139 mL/min for moderate RI, severe RI, and healthy controls, respectively). Although no participants with mild RI were included in this study, their BSA non-normalized eGFR estimates were predicted at midpoint 75 mL/min.|Part 1 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All participants in Part 1 who were compliant with the study procedure and had available data were included. For non-normalized eGFR estimates, participants originally assigned to the severe RI group were reassigned: 1 participant reassigned to the mild RI group (excluded from analysis), and 1 participant reassigned to the moderate RI group.|||L/hr||95% Confidence Interval|Mean
2538159|NCT03108924|Primary|[Part 1] Estimated CL/F of Gefapixant 50 mg in Participants With BSA-Normalized eGFR (Regression Analysis)|CL/F values of plasma gefapixant based on BSA-normalized eGFR for participants with moderate RI, severe RI, or normal renal function (i. e., Healthy Controls) were estimated using regression analysis. Individual values of CL/F were natural log-transformed and evaluated with a linear fixed-effects model containing BSA-normalized eGFR as a continuous variable. The back transformed mean CL/F and corresponding 95% CI were predicted at the midpoint of the BSA enormalized eGFR range for each group (45 mL/min, 22.5 mL/min, and 139 mL/min for moderate RI, severe RI, and healthy controls, respectively). Although no participants with mild RI were included in this study, their normalized eGFR estimates were predicted at midpoint 75 mL/min.|Part 1 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All participants in Part 1 who were compliant with the study procedure and had available data were included.|||L/hr||95% Confidence Interval|Mean
2538160|NCT03108924|Primary|[Part 2] Geometric Least Squares Mean CL/F of Gefapixant 50 mg in ESRD HD Participants vs. ESRD Non-HD Participants (Categorical Analysis)|To evaluate the extent of gefapixant removal by hemodialysis, individual values of CL/F, were ln-transformed and analyzed using a linear mixed-effects model with population (ESRD Non-HD, ESRD HD) as a fixed effect. An unstructured covariance matrix was used to allow for unequal variances and to model the correlation between the 2 measurements within each participant. A two-sided 90% CI for the true difference in means was calculated for CL/F. These confidence limits were exponentiated to obtain the 90% CI for the geometric least squares mean ratio (GMR) (ESRD HD/ESRD Non-HD) for CL/F.|Part 2 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All participants in Part 2 who were compliant with the study procedure and had available data were included. A single participant with 6 missing plasma samples in Part 2, Period 1 was excluded from the ESRD Non-HD group. The ESRD Non-HD and ESRD HD arms are a split of the original ESRD arm. The same 6 participants were in Periods 1 and 2.|||L/hr||95% Confidence Interval|Geometric Least Squares Mean
2538161|NCT03108924|Primary|[Parts 1 and 2] Apparent Clearance (CL/F) of Gefapixant 50 mg|The apparent clearance (CL/F) of plasma gefapixant after oral administration of gefapixant 50 mg in participants with moderate RI, severe RI, ESRD requiring HD, or normal renal function (i. e., Healthy Controls) was assessed. Non-model based summary statistics were provided for the number of participants with non-missing data, as well as mean and standard deviation values. Serial blood samples for the determination of plasma gefapixant concentrations were collected at predose and at selected time points over 72 hours postdose.|Parts 1 and 2 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All participants in Parts 1 and 2 who were compliant with the study procedure and had available data were included. The ESRD Non-HD and ESRD HD arms were split from the original ESRD arm. The same 6 participants were in Periods 1 and 2.|||L/hr||Standard Deviation|Mean
2538162|NCT03108924|Primary|[Part 1 and 2] Estimated Cmax of Gefapixant 50 mg in Participants With Moderate RI, Severe RI, ESRD Non-HD, or Normal Renal Function (Categorical Analysis)|Geometric mean and 95%CI for Cmax were estimated in participants with moderate RI, severe RI, ESRD requiring but not receiving HD, and normal renal function (i. e., Healthy Controls). Individual values of Cmax, were ln-transformed and evaluated with a linear fixed-effects heterogeneous variance model containing a categorical effect for population (ESRD Non-HD, severe RI, moderate RI, and healthy matched control, based on BSA normalized eGFR). To compare subjects with RI in each of the renal categories to subjects with normal renal function, a two-sided 90% CI for the true difference in means (renal impairment - normal renal function) was calculated for Cmax, using the mean square error from the model and referencing a t-distribution. For each of the RI populations, these confidence limits were exponentiated to obtain the 90% CI for the GMR (renal impairment/normal renal function).|Parts 1 and 2 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All Parts 1 and 2 participants who were compliant with the study procedure and had available data were included. A single participant was excluded from the ESRD Non-HD group since this participant had 6 missing peripheral plasma samples in Part 2, Period 1.|||ng/mL||95% Confidence Interval|Geometric Least Squares Mean
2538163|NCT03108924|Primary|[Part 1] Estimated Cmax of Gefapixant 50 mg in Participants With BSA Non-Normalized eGFR (Regression Analysis)|Cmax values of plasma gefapixant based on BSA non-normalized eGFR for participants with moderate RI, severe RI, or normal renal function (i. e., Healthy Controls) were estimated using regression analysis. Individual values of Cmax were natural log-transformed and evaluated with a linear fixed-effects model containing BSA non-normalized eGFR as a continuous variable. The back transformed mean Cmax and corresponding 95% CI were predicted at the midpoint of the BSA non-normalized eGFR range for each group (45 mL/min, 22.5 mL/min, and 139 mL/min for moderate RI, severe RI, and healthy controls, respectively). Although no participants with mild RI were included in this study, their BSA non-normalized eGFR estimates were predicted at midpoint 75 mL/min. Serial blood samples for the determination of plasma gefapixant concentrations were collected at predose and at selected time points over 72 hours postdose.|Part 1 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All participants in Part 1 who were compliant with the study procedure and had available data were included. For non-normalized eGFR estimates, participants originally assigned to the severe RI group were reassigned: 1 participant reassigned to the mild RI group (excluded from analysis), and 1 participant reassigned to the moderate RI group.|||ng/mL||95% Confidence Interval|Mean
2538164|NCT03108924|Primary|[Part 1] Estimated Cmax of Gefapixant 50 mg in Participants With BSA-Normalized eGFR (Regression Analysis)|Cmax values of plasma gefapixant based on BSA-normalized eGFR for participants with moderate RI, severe RI, or normal renal function (i. e., Healthy Controls) were estimated using regression analysis. Individual values of Cmax were natural log-transformed and evaluated with a linear fixed-effects model containing BSA-normalized eGFR as a continuous variable. The back transformed mean Cmax and corresponding 95% CI were predicted at the midpoint of the BSA enormalized eGFR range for each group (45 mL/min, 22.5 mL/min, and 139 mL/min for moderate RI, severe RI, and healthy controls, respectively). Although no participants with mild RI were included in this study, their normalized eGFR estimates were predicted at midpoint 75 mL/min. Serial blood samples for the determination of plasma gefapixant concentrations were collected at predose and at selected time points over 72 hours postdose.|Part 1 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All participants in Part 1 who were compliant with the study procedure and had available data were included.|||ng/mL||95% Confidence Interval|Mean
2538165|NCT03108924|Primary|[Part 2] Geometric Least Squares Mean Cmax of Gefapixant 50 mg in ESRD HD Participants vs. ESRD Non-HD Participants (Categorical Analysis)|To evaluate the extent of gefapixant removal by hemodialysis, individual values of Cmax, were ln transformed and analyzed using a linear mixed-effects model with population (ESRD Non-HD, ESRD HD) as a fixed effect. An unstructured covariance matrix was used to allow for unequal variances and to model the correlation between the 2 measurements within each participant. A two-sided 90% CI for the true difference in means was calculated for Cmax. These confidence limits were exponentiated to obtain the 90% CI for the geometric least squares mean ratio (GMR) (ESRD HD/ESRD Non-HD) for Cmax.|Part 2 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All participants in Part 2 who complied with the study procedure and had available data were included. A single participant with 6 missing plasma samples in Part 2, Period 1 was excluded from the ESRD Non-HD group. The ESRD Non-HD and ESRD HD arms were split from the original ESRD arm. The same 6 participants were in Periods 1 and 2.|||ng/mL||95% Confidence Interval|Geometric Least Squares Mean
2538166|NCT03108924|Primary|[Parts 1 and 2] Maximum Concentration (Cmax) of Gefapixant 50 mg|The maximum concentration (Cmax) of plasma gefapixant in participants with moderate RI, severe RI, ESRD Non-HD, ESRD HD, or normal renal function (i. e., Healthy Controls) following administration of gefapixant 50 mg was assessed. Non-model based summary statistics were provided for the number of participants with non-missing data, as well as mean and standard deviation values. Serial blood samples for the determination of plasma gefapixant concentrations were collected at predose and at selected time points over 72 hours postdose.|Parts 1 and 2 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All participants in Parts 1 and 2 who were compliant with the study procedure and had available data were included in the primary analysis dataset at the end of the study. The ESRD Non-HD and ESRD HD arms are a split of the original ESRD arm. The same 6 participants were in both Periods 1 and 2.|||ng/mL||Standard Deviation|Mean
2538167|NCT03108924|Primary|[Parts 1 and 2] Estimated AUC0-last of Gefapixant 50 mg in Participants With Moderate RI, Severe RI, ESRD Non-HD, or Normal Renal Function (Categorical Analysis)|Geometric mean and 95%CI for AUC0-last were estimated in participants with moderate RI, severe RI, ESRD requiring but not receiving HD, and normal renal function (i. e., Healthy Controls). Individual values of AUC0-last, were ln-transformed and evaluated with a linear fixed-effects heterogeneous variance model containing a categorical effect for population (ESRD Non-HD, severe RI, moderate RI, and healthy matched control, based on BSA normalized eGFR). To compare subjects with RI in each of the renal categories to subjects with normal renal function, a two-sided 90% CI for the true difference in means (renal impairment - normal renal function) was calculated for AUC0-last, using the mean square error from the model and referencing a t-distribution. For each of the RI populations, these confidence limits were exponentiated to obtain the 90% CI for the GMR (renal impairment/normal renal function).|Parts 1 and 2 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All participants in Parts 1 and 2 who were compliant with the study procedure and had available data were included. A single participant was excluded from the ESRD Non-HD group since this participant had 6 missing peripheral plasma samples in Part 2, Period 1.|||ng*hr/mL||95% Confidence Interval|Geometric Least Squares Mean
2538168|NCT03108924|Primary|[Part 1] Estimated AUC0-last of Gefapixant 50 mg in Participants With BSA Non-Normalized eGFR (Regression Analysis)|AUC0-last values of plasma gefapixant based on BSA non-normalized eGFR for participants with moderate RI, severe RI, or normal renal function (i. e., Healthy Controls) were estimated using regression analysis. Individual values of AUC0-last were natural log-transformed and evaluated with a linear fixed-effects model containing BSA non-normalized eGFR as a continuous variable. The back transformed mean AUC0-last and corresponding 95% CI were predicted at the midpoint of the BSA non-normalized eGFR range for each group (45 mL/min, 22.5 mL/min, and 139 mL/min for moderate RI, severe RI, and healthy controls, respectively). Although no participants with mild RI were included in this study, their BSA non-normalized eGFR estimates were predicted at midpoint 75 mL/min.|Part 1 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All participants in Part 1 who were compliant with the study procedure and had available data were included. For non-normalized eGFR estimates, participants originally assigned to the severe RI group were reassigned: 1 participant reassigned to the mild RI group (excluded from analysis), and 1 participant reassigned to the moderate RI group.|||ng*hr/mL||95% Confidence Interval|Mean
2538169|NCT03108924|Primary|[Part 1] Estimated AUC0-last of Gefapixant 50 mg in Participants With BSA-Normalized eGFR (Regression Analysis)|AUC0-last values of plasma gefapixant based on BSA-normalized eGFR for participants with moderate RI, severe RI, or normal renal function (i. e., Healthy Controls) were estimated using regression analysis. Individual values of AUC0last were natural log-transformed and evaluated with a linear fixed-effects model containing BSA-normalized eGFR as a continuous variable. The mean AUC0-ilast and corresponding 95% CI were back-transformed and predicted at the midpoint of th BSA enormalized eGFR range for each group (45 mL/min, 22.5 mL/min, and 139 mL/min for moderate RI, severe RI, and healthy controls, respectively). Although no participants with mild RI were included in this study, their normalized eGFR estimates were predicted at midpoint 75 mL/min.|Part 1 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All participants in Part 1 who were compliant with the study procedure and had available data were included.|||ng*hr/mL||95% Confidence Interval|Mean
2539490|NCT03070730|Secondary|Change in Physical Functioning-MFI From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Multidimensional Fatigue Inventory (MFI).|1 week after first intervention|||||||
2538170|NCT03108924|Primary|[Part 2] Geometric Least Squares Mean AUC0-last of Gefapixant 50 mg in ESRD HD Participants vs. ESRD Non-HD Participants (Categorical Analysis)|To evaluate the extent of gefapixant removal by hemodialysis, individual values of AUC0-last, were ln-transformed and analyzed using a linear mixed-effects model with population (ESRD Non-HD, ESRD HD) as a fixed effect. An unstructured covariance matrix was used to allow for unequal variances and to model the correlation between the 2 measurements within each participant. A two-sided 90% CI for the true difference in means was calculated for AUC0-last. These confidence limits were exponentiated to obtain the 90% CI for the geometric least squares mean ratio (GMR) (ESRD HD/ESRD Non-HD) for AUC0-last.|Part 2 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All participants in Part 2 who complied with the study procedure and had available data were included. A single participant with 6 missing plasma samples in Part 2, Period 1 was excluded from the ESRD Non-HD group. The ESRD Non-HD and ESRD HD arms were split from the original ESRD arm. The same 6 participants were in Periods 1 and 2.|||ng*hr/mL||95% Confidence Interval|Geometric Least Squares Mean
2538171|NCT03108924|Primary|[Parts 1 and 2] Mean Area Under the Concentration-Time Curve of From Time Zero to the Last Quantifiable Sample (AUC0-last) of Gefapixant 50 mg|The mean area under the concentration-time curve from time 0 to the last quantifiable sample (AUC0-last), above the lower limit of quantitation (LLOQ), of plasma gefapixant in participants with moderate RI, severe RI, ESRD, or normal renal function (i. e., Healthy Controls) was assessed. Non-model based summary statistics were provided for the number of participants with non-missing data, as well as mean and standard deviation values.|Parts 1 and 2 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All participants in Parts 1 and 2 who were compliant with the study procedure and had available data were included. The ESRD Non-HD and ESRD HD arms are a split of the original ESRD arm. The same 6 participants are in both Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
2538172|NCT03108924|Primary|[Part 1 and 2] Estimated AUC0-inf of Gefapixant 50 mg in Participants With Moderate RI, Severe RI, ESRD Non-HD, or Normal Renal Function (Categorical Analysis)|Geometric mean and 95%CI for AUC0-inf were estimated in participants with moderate RI, severe RI, ESRD requiring but not receiving HD, and normal renal function (i. e., Healthy Controls). Individual values of AUC0-inf, were ln-transformed and evaluated with a linear fixed-effects heterogeneous variance model containing a categorical effect for population (ESRD Non-HD, severe RI, moderate RI, and healthy matched control, based on BSA normalized eGFR). To compare subjects with RI in each of the renal categories to subjects with normal renal function, a two-sided 90% CI for the true difference in means (renal impairment - normal renal function) was calculated for AUC0-inf, using the mean square error from the model and referencing a t-distribution. For each of the RI populations, these confidence limits were exponentiated to obtain the 90% CI for the GMR (renal impairment/normal renal function).|Parts 1 and 2 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All participants in Parts 1 and 2 were compliant with the study procedure and had available data were included. A single participant with 6 missing plasma samples in Part 2, Period 1 was excluded from the ESRD Non-HD group. The same 6 participants were in Periods 1 and 2.|||ng*hr/mL||95% Confidence Interval|Geometric Least Squares Mean
2538173|NCT03108924|Primary|[Part 1] Estimated AUC0-inf of Gefapixant 50 mg in Participants With BSA Non-Normalized eGFR (Regression Analysis)|AUC0-inf values of plasma gefapixant based on BSA non-normalized eGFR for participants with moderate RI, severe RI, or normal renal function (i. e., Healthy Controls) were estimated using regression analysis. Individual values of AUC0-inf were natural log-transformed and evaluated with a linear fixed-effects model containing BSA non-normalized eGFR as a continuous variable. The back transformed mean AUC0-inf and corresponding 95% CI were predicted at the midpoint of the BSA non-normalized eGFR range for each group (45 mL/min, 22.5 mL/min, and 139 mL/min for moderate RI, severe RI, and healthy controls, respectively). Although no participants with mild RI were included in this study, their BSA non-normalized eGFR estimates were predicted at midpoint 75 mL/min.|Part 1 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All participants in Part 1 who were compliant with the study procedure and had available data were included. For non-normalized eGFR estimates, participants originally assigned to the severe RI group were reassigned: 1 participant reassigned to the mild RI group (excluded from analysis), and 1 participant reassigned to the moderate RI group.|||ng*hr/mL||95% Confidence Interval|Mean
2538174|NCT03108924|Primary|[Part 1] Estimated AUC0-inf of Gefapixant 50 mg in Participants With Body Surface Area (BSA)-Normalized Estimated Glomerular Filtration Rate (eGFR) (Regression Analysis)|AUC0-inf values of plasma gefapixant based on BSA-normalized eGFR for participants with moderate RI, severe RI, or normal renal function (i. e., Healthy Controls) were estimated using regression analysis. Individual values of AUC0-inf were natural log-transformed and evaluated with a linear fixed-effects model containing BSA-normalized eGFR as a continuous variable. The back transformed mean AUC0-inf and corresponding 95% CI were predicted at the midpoint of the BSA enormalized eGFR range for each group (45 mL/min, 22.5 mL/min, and 139 mL/min for moderate RI, severe RI, and healthy controls, respectively). Although no participants with mild RI were included in this study, their normalized eGFR estimates were predicted at midpoint 75 mL/min.|Part 1 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All participants in Part 1 who were compliant with the study procedure and had available data were included.|||ng*hr/mL||95% Confidence Interval|Mean
2538175|NCT03108924|Primary|[Part 2] Geometric Least Squares Mean (GM) AUC0-inf in ESRD HD Participants vs. ESRD Non-HD Participants (Categorical Analysis)|To evaluate the extent of gefapixant removal by hemodialysis, individual values of AUC0-inf, were natural log (ln)-transformed and analyzed using a linear mixed-effects model with population (ESRD Non-HD, ESRD HD) as a fixed effect. An unstructured covariance matrix was used to allow for unequal variances and to model the correlation between the 2 measurements within each participant. A two-sided 90% confidence interval (CI) for the true difference in means was calculated for AUC0-inf. These confidence limits were exponentiated to obtain the 90% CI for the geometric least squares mean ratio (GMR) (ESRD HD/ESRD Non-HD) for AUC0-inf.|Part 2 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All participants in Part 2 who were compliant with the study procedure and had available data were included. A single participant with 6 missing plasma samples in Part 2, Period 1 was excluded from the ESRD Non-HD group. The ESRD Non-HD and ESRD HD arms are a split of the original ESRD arm. The same 6 participants were in Periods 1 and 2.|||ng*hr/mL||95% Confidence Interval|Geometric Least Squares Mean
2545592|NCT02940327|Primary|CD16/41|Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.|48 hours after ECMO commencement||||percentage change||Standard Deviation|Mean
2538176|NCT03108924|Primary|[Parts 1 and 2] Mean Area Under the Concentration-Time Curve From Time Zero Up to Infinity (AUC0-inf) of Gefapixant 50 mg (Categorical Analysis)|The mean area under the concentration-time curve from time 0 to infinity (AUC0-inf) of plasma gefapixant was assessed. In Part 1, participants with Moderate RI, Severe RI, or normal renal function (i. e., Healthy Controls) received a single oral dose of gefapixant 50 mg at Hour 0 on Day 1. In Part 2, Period 1, ESRD participants received a single oral dose of gefapixant 50 mg at Hour 0 on Day 1, immediately following the scheduled HD. In Part 2, Period 2, participants received a single oral dose of gefapixant 50 mg at Hour 0 on Day 1, approximately 2 hours prior to initiation of HD. Non-model based summary statistics were provided for the number of participants with non-missing data, as well as mean and standard deviation values. Serial blood samples for the determination of plasma gefapixant concentrations were collected at predose and at selected time points over 72 hours postdose.|Parts 1 and 2 - Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|All participants in Parts 1 and 2 who were compliant with the study procedure and had available data were included. The ESRD Non-HD and ESRD HD arms are a split of the original ESRD arm. The same 6 participants are in both Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
2538177|NCT03108482|Primary|Sum of Pain Intensity Differences (SPID)|"The primary efficacy variable was the Pain Intensity (PI) measured by the Numerical Pain Rating Scale (NPRS); a scale from zero to 10 on which subjects circled a single number to indicate current pain level, with zero representing No Pain and 10 representing Worst Possible Pain. The primary analysis endpoint was the Sum of Pain Intensity Differences (SPID) from 0 to 48 hours. Pain Intensity Differences (PID) was the difference between current PI at assessment minus baseline PI (prior to the first dose). Baseline PI ranged from 5 to 9. SPID was calculated as a time-weighted Sum of PID scores over 48 hours. Negative differences correspond to an amelioration of pain, while positive differences correspond to recrudescence of pain. The total scale ranged from -480 (best) to +480 (worst). A higher negative value of SPID indicates greater pain relief."|Assessments was recorded from time 0 to 48 hours.|Full Analysis Set (Study Treatments as randomized)|||units on a scale||95% Confidence Interval|Least Squares Mean
2538178|NCT03108469|Secondary|Subject Global Impress of Change (SGIC) Score|"Compare the end of treatment month 4 in the subjects' global impression of change (SGIC) for subjects treated with ISIS 546254 vs. placebo.~The SGIC is a one item questionnaire asking, Since the beginning of treatment in this study, how would you describe the change (if any) in your overall status?. The answer option for the SGIC is coded as: 3 = Very Much Improved, 2 = Much Improved, 1 = Minimally Improved, 0 = No Change, -1 = Minimally Worse, -2 = Much Worse, -3 = Very Much Worse, with negative scores indicating the subject's overall status has decreased while in the study and positive scores indicating the subject's overall status has increased while in the study."|Evaluating the treatment period, but collected at the end of treatment, up to 16 weeks||||units on a scale||Standard Error|Mean
2538179|NCT03108469|Secondary|Physician Global Impress of Change (PGIC) Score|"Compare the end of treatment month 4 in the physician global impress of change (PGIC) for subjects treated with ISIS 546254 vs. placebo.~The PGIC is a one item questionnaire asking, Since the beginning of treatment in this study, how would you describe this patient's change (if any) in their overall status?. The answer option for the PGIC is coded as: 3 = Very Much Improved, 2 = Much Improved, 1 = Minimally Improved, 0 = No Change, -1 = Minimally Worse, -2 = Much Worse, -3 = Very Much Worse, with negative scores indicating the subject's overall status has decreased while in the study and positive scores indicating the subject's overall status has increased while in the study."|Evaluating the treatment period, but collected at the end of treatment, up to 16 weeks||||units on a scale||Standard Error|Mean
2538180|NCT03108469|Secondary|Migraine Specific Quality of Life (MSQ) Questionnaire Score|"Compare scores from baseline to the final month of the 4-month treatment period in the Migraine Specific Quality of Life (MSQ) Questionnaire for subjects treated with ISIS 546254 vs. placebo.~The MSQ total score is derived from the summation of fourteen questions on the MSQ. Answer options for the MSQ are coded as: 1 = None of the time, 2 = A little bit of the time, 3 = Some of the time, 4 = A good bit of the time, 5 = Most of the time, 6 = All of the time. The range of total MSQ score for each time point is 14 to 84, with higher scores indicating more effects of migraine on the subject's daily activities."|Comparing baseline to treatment period, up to 16 weeks||||score on a scale||Standard Error|Mean
2538181|NCT03108469|Secondary|Count of Migraine Headache Days Requiring Use of Migraine Medication|Compare the count of the number of headache days requiring use of medication for the treatment of migraine or headache pain (i.e., acute and rescue or breakthrough medication use) from baseline to the final month of the 4-month treatment period for subjects treated with ISIS 546254 vs. placebo.|Comparing baseline to treatment period, up to 16 weeks||||Days||Standard Error|Mean
2538182|NCT03108469|Secondary|Number of Subjects Reporting a ≥ 50% Reduction in the Number of Migraine Headaches|Compare the number of patients meeting 50% response criteria, response defined as a ≥ 50% reduction in the number of headaches from baseline to the final month of the 4-month treatment period for subjects treated with ISIS 546254 vs. placebo.|Comparing baseline to treatment period, up to 16 weeks||||Participants|||Count of Participants
2538183|NCT03108469|Secondary|Headache Days|Compare the efficacy of ISIS 546254 in the preventive treatment of chronic migraine, measured by the number of monthly headache days comparing baseline to the final month of the 4-month treatment period for subjects treated with ISIS 546254 vs. placebo.|Comparing baseline to treatment period, up to 16 weeks||||Days||Standard Error|Mean
2538184|NCT03108469|Secondary|Headache Severity|Evaluate the efficacy of ISIS 546254 in the preventive treatment of chronic migraine, measured by the monthly headache severity comparing baseline to the final month of the 4-month treatment period for subjects treated with ISIS 546254 vs. placebo. Headache severity scale ranges from 1 (Mild) to 3 (Severe).|Comparing baseline to treatment period, up to 16 weeks||||units on a scale||Standard Error|Mean
2538185|NCT03108469|Primary|Migraine Days|Compare the efficacy of ISIS 546254 in the preventive treatment of chronic migraine, measured by the number of monthly migraine days comparing baseline to the final month of the 4-month treatment period for subjects treated with ISIS 546254 vs. placebo.|Comparing baseline to treatment period, up to 16 weeks||||Days||Standard Error|Mean
2538186|NCT03108157|Primary|Positive Pregnancy Test|Positive test (hcG>10 UI/ml)|12 to 14 days after embryo transfer||||Participants|||Count of Participants
2538216|NCT03105362|Secondary|Tolerance: Reported Episodes of Abdominal Distension and Emesis|Number of episodes reported of abdominal distension and emesis during study period|14 days|Participants consuming amino acid oral rehydration solution (enterade)|||Episodes|||Number
2538188|NCT03108027|Secondary|Trough FEV1 After 24h|FEV1 at approximately 24 h after the last p.m. or penultimate a.m. dose. Morning and evening trough FEV1 (L) were analyzed by time of day. For morning trough FEV1 (L) assessments this meant that the spirometric assessment was done approximately 24 h after last morning dose and approximately 12 h after last evening dose.|At the end of each treatment period day 14 pre-dose to 24 hours post-dose.|The pharmacodynamic (PD) analysis set included all patients with any available PD data, who received any dose of study drug and experienced no protocol deviations with relevant impact on PD data|||Liters||Standard Error|Least Squares Mean
2538189|NCT03108027|Primary|FEV1 Standardized Area Under the Curve (AUC 0-24h) After Last Evening Dose of 14-day Treatment Period|Weighted mean forced expiratory volume in 1 second (FEV1) over 24 h (AUC0-24h) following 14 days of treatment with QVM149 dosed in the morning, QVM149 dosed in the evening and placebo.|At the end of each treatment period day 14 pre-dose to 24 hours post-dose.|The pharmacodynamic (PD) analysis set included all patients with any available PD data, who received any dose of study drug and experienced no protocol deviations with relevant impact on PD data.|||Liters||Standard Error|Least Squares Mean
2538190|NCT03107611|Secondary|Evaluation of Application Site Reactions|Dryness, burning/stinging, erosion, edema, and pain|Day 15|Safety with data for this parameter|||Participants|||Count of Participants
2538191|NCT03107611|Secondary|Change in Severity of Four Individual Signs and Symptoms|Erythema, induration/papulation, lichenification and pruritus|Day 15|PP sample|||Participants|||Count of Participants
2538192|NCT03107611|Primary|Proportion of Per Protocol Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])|Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting|Day 15|PP (per protocol) sample|||Participants|||Count of Participants
2538193|NCT03107611|Primary|Proportion of Modified Intent to Treat Subjects With Success on Investigator's Global Assessment of Disease Severity (Success Being a Score of Clear [0] or Almost Clear [1])|Investigator's Global Assessment of Disease Severity Scale: Clear (0) Minor residual discoloration, no erythema or induration/papulation, no oozing/crusting; Almost Clear (1) Trace faint pink erythema with almost no induration/papulation and no oozing/crusting; Mild disease (1) Faint pink erythema with mild induration/papulation and no oozing/crusting; Moderate disease (3) Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting; Severe disease (4) Deep/bright red erythema with severe induration/papulation with oozing/crusting|Day 15|Modified ITT (Intent-to-treat) sample|||Participants|||Count of Participants
2538194|NCT03106870|Secondary|Number of Participants With Neonates Who Were Hypoglycemic|Neonatal hypoglycemia defined as a plasma glucose level of less than 30 mg/dL in the first 24 hours after delivery|24 hours after delivery||||Participants|||Count of Participants
2538195|NCT03106870|Secondary|Number of Participants With a Macrosomic Baby|Fetal macrosomia has been defined birth weight greater than 4500 gm|24 hours after delivery||||Participants|||Count of Participants
2538196|NCT03106870|Primary|Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation|"Fasting and two-hours postprandial blood glucose every 48 hours, till reaching the target blood glucose concentrations:~60 - 95 mg/dl and < 120 mg/dl (for fasting and two-hour postprandial status, respectively) If patient reached blood glucose concentrations, she considered as controlled Diabetes Mellitus If patient did not reach blood glucose concentrations, she considered as uncontrolled Diabetes Mellitus"|from 20 weeks to 36 weeks gestation||||Participants|||Count of Participants
2538197|NCT03106337|Primary|Shear-Wave Elastography (SWE) Values in kiloPascals (kPa)|Elastography provides a quantitative score of thyroid nodule stiffness that is expected to correlate with the biological nature of the nodule. Mean SWE values, in three planes: traverse plane, sagittal plane and transverse plane with nodule in the center, of all benign lesions were compared with mean SWE values of all malignant lesions on histopathology obtained post surgery.|Baseline (Day 0)|All enrolled participants.|||kPa||Standard Deviation|Mean
2538198|NCT03105518|Secondary|Amount of Discomfort Following Discharge Until Embryo Transfer|Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale) after immediate postoperative period (1 hrs) but prior to Embryo Transfer on 3rd postoperative day. Visual Analogue Scale (VAS) scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort. Patients will record the type, dose, and timing of pain medicines in a diary to be returned at Embryo Transfer.|After 1 hrs but less than 3 days|All 100 parturients analyzed; divided into those who had less than, compared to more than 10 follicles on preoperative ultrasound image.|||units on a scale||Standard Deviation|Mean
2538199|NCT03105518|Primary|Amount of Discomfort|Change in discomfort following oocyte retrieval with standardized anesthesia management as measured by verbal analogue scoring (0-10 scale). VAS scores correlate to minimal (VAS 0-3), moderate (VAS 4-6) or severe (VAS ≥7) discomfort.|PACU admission, 15, 30 and 60 min postprocedure, postoperative day 3|On PACU admission, subjects were divided into three groups based on the intensity of discomfort. A standardized postoperative analgesic regimen followed, based on VAS score and time (≤ or > than 30 min).|||units on a scale||Standard Deviation|Mean
2538200|NCT03105479|Secondary|Treatment-emergent Adverse Events (TEAES)|Number of subjects with any TEAEs. A TEAE is any adverse event temporally associated with the use of study treatment (from study treatment initiation until 7 days after study treatment discontinuation) whether or not considered by the investigator as related to study treatment.|Day 17 (on average)|Due to premature termination, no subject was enrolled in Part B. Consequently, no data can be reported during Part B|||Participants|||Count of Participants
2538201|NCT03105479|Secondary|Marked Abnormalities in Vital Signs|Number of subjects with any treatment-emergent abnormalities in vital signs (up to 7 days after end of treatment)|Day 17 (on average)|Due to premature termination, no subject was enrolled in Part B. Consequently, no data can be reported during Part B|||Participants|||Count of Participants
2539491|NCT03070730|Secondary|Change in Physical Functioning-CIS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Checklist Individual Strength (CIS).|1 week after third intervention|||||||
2538202|NCT03105479|Secondary|Marked Abnormalities in Clinical Laboratory Parameters|Number of participants with any marked abnormalities in laboratory parameters up to 7 days after end of treatment|Day 17 (on average)|Due to premature termination, no subject was enrolled in Part B. Consequently, no data can be reported during Part B|||Participants|||Count of Participants
2538203|NCT03105479|Secondary|Adverse Events Leading to Premature Discontinuation of Study Treatment|Number of participants who prematurely discontinued the study treatment due to an adverse event|Up to Day 10|Due to premature termination, no subject was enrolled in Part B. Consequently, no data can be reported during Part B|||Participants|||Count of Participants
2538204|NCT03105479|Secondary|Time to Resolution of Diarrhea in Part B|This is the time (in days) elapsed between the first dose of study treatment and the resolution of diarrhea and reported as Kaplan-Meier estimates (KM estimates). The date of resolution of Diarrhea (ROD) is defined as the date of the first day of the 2 consecutive days on treatment with < 3 UBM (or no watery diarrhea for subjects < 2 years of age). Time to ROD is the time (in days) elapsed between the first dose of study treatment and the ROD|Day 10|Due to premature termination, data were collected from only one subject, consequently KM estimates cannot be calculated and no statistical analyses can be performed||||||
2538205|NCT03105479|Secondary|Time to Recurrence in Part B|This it the time (in days) elapsed between the last dose of study drug and the onset day of new episode of diarrhea reported as Kaplan-Meier estimates (KM estimates)|Day 40 (on average)|Due to premature termination, no subject was enrolled in Part B. Consequently, no data can be reported during Part B||||||
2538206|NCT03105479|Secondary|Recurrence Rate During Part A and Part B|This is the percentage of participants in Parts A and B assessed as having a recurrence out of subjects meeting the criteria for Clinical Cure. Recurrence is defined as: • Clinical Cure AND New episode of diarrhea with ≥ 3 UBMs (or watery diarrhea if subject < 2 years) on any day between EOT + 3 days and end of study AND • Stool test showing positive C. difficile (as defined in Inclusion Criterion 4), AND •Antimicrobial treatment active against CDAD started between EOT + 3 days and end of study.|Day 40 (on average)|Due to the premature termination of the study and consequent lack of meaningful data, no analyses were performed.||||||
2538207|NCT03105479|Secondary|Sustained Clinical Cure Rate During Part A and Part B|This is the percentage of participants in Parts A and B reported as with sustained clinical cure. Sustained clinical cure is defined as • Clinical Cure and no Recurrence until 30 days after the last study drug intake (end of study).|Day 40 (on average)|Due to the premature termination of the study and consequent lack of meaningful data, no analyses were performed.||||||
2538208|NCT03105479|Secondary|Clinical Cure Rate During Part A|This is the percentage of participants in Part A reported as with a clinical cure. Clinical Cure is defined as: • <3 unformed bowel movement (UBM) per day (or no water diarrhea if subjects < 2 years of age), for at least 2 consecutive days between first dose of study treatment up to end of treatment (EOT) (inclusive) AND • Subject remains well up to EOT + 2 days (inclusive) based on investigator judgment AND • No need for additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) between first dose of study treatment up to EOT + 2 days (inclusive).|Day 10 (End of Treatment) + 2 days|Due to premature termination, data were collected from only one subject, consequently percentage of participants with clinical cure cannot be calculated and no statistical analyses can be performed||||||
2538209|NCT03105479|Primary|Fecal Concentrations of Cadazolid During Part A|A fecal sample is collected as the end-of-treatment visit in all participants in Part A.|Day 10 (End of Treatment)|Due to premature termination, fecal sample was collected from only one subject, consequently mean values cannot be provided and no statistical analyses can be performed.|||mcg/g|||Number
2538210|NCT03105479|Primary|Area Under the Plasma Concentration Time Curve (AUC) of Cadazolid During Part A|Blood samples are collected at different timepoints for the determination of the cadazolid AUC over one dosing interval (0-12h) on Day 10.|Day 10 (End of Treatment)|Due to the premature study termination, cadazolid concentrations were obtained from only one subject and pharmacokineitc plasma profile was not analyzed because of lack of meaningful data.||||||
2538211|NCT03105479|Primary|Time to Reach Cmax (Tmax) of Cadazolid During Part A|Blood samples are collected at different timepoints to determine the time when the maximal plasma concentration of cadazolid is reached.|Day 10 (End of Treatment)|Due to the premature study termination, cadazolid concentrations were obtained from only one subject and pharmacokineitc plasma profile was not analyzed because of lack of meaningful data.||||||
2538212|NCT03105479|Primary|Maximal Plasma Concentration (Cmax) of Cadazolid During Part A|Blood samples are collected at different timepoints on Day 10 for the determination of cadazolid Cmax after 10 days of treatment.|Day 10 (End of Treatment)|Due to the premature study termination, cadazolid concentrations were obtained from only one subject and pharmacokineitc plasma profile was not analyzed because of lack of meaningful data.||||||
2538213|NCT03105479|Primary|Clinical Cure Rate During Part B|This is the percentage of participants in part B reported as with a clinical cure. Clinical Cure is defined as: • <3 unformed bowel movement (UBM) per day (or no water diarrhea if subjects < 2 years of age), for at least 2 consecutive days between first dose of study treatment up to end of treatment (EOT) (inclusive) AND • Subject remains well up to EOT + 2 days (inclusive) based on investigator judgment AND • No need for additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) between first dose of study treatment up to EOT + 2 days (inclusive). percentage of subjects with a clinical cure|Day 10 (End of Treatment) + 2 days|Due to the premature study termination, no subject was enrolled into Part B and consequently the percentage of subjects with a clinical cure could not be reported.||||||
2538214|NCT03105362|Primary|Average Stool Output Difference (First Week v. Second Week) for Patients in Intestinal Continuity|Output was measured as frequency of stools per day. The mean output was compared between week 1(day 1-7) and week 2 (day 8-14). The difference (of the means) between weeks were reported.|Total study duration 14 days|Participants consumed amino acid-based ORS (enterade)|||Stools per day||Full Range|Mean
2538215|NCT03105362|Other Pre-specified|Palatability Rating of Amino Acid ORS (Enterade®) Compared to Baseline ORS|"Rating of enterade® taste was compared to previous patient baseline oral rehydration solution taste. We compared measurements using the facial hedonic method 100-mm visual analog scale (worst (0mm) and best taste(100mm)). We utilized the difference between two measurements: Day 0 (baseline ORS) and Day 14 (last study day of Amino Acid-ORS consumption). The difference was reported (Day 14 minus value at Day 0)."|14 days|Participants consuming enterade (amino acid oral rehydration solution)|||mm||Full Range|Mean
2538217|NCT03105362|Primary|Average Stool Output Difference (First Week v. Second Week) for Patients With Ostomy|Ostomy output measured as milliliters per day. The mean of outputs where compared between week 1(day 1-7) and week 2 (day 8-14). The difference (of the means) between weeks were reported.|Total study duration14 days|Participants consumed amino acid-based ORS (enterade)|||mL/day||Full Range|Mean
2538218|NCT03105297|Secondary|Apnea/Hypopnea Index (AHI) : Baseline, Active and Nasal Resistance Phase|Apnea/Hypopnea Index (AHI) was measured as the number of events (apnea and hypopnea) per hour of sleep. AHI was measured using overnight by PSG using a computerized system. PSG was performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.|Day 1, Day 8, Day 29, Day 30 and Day 31|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.|||AHI events per hour||Standard Deviation|Mean
2538219|NCT03105297|Secondary|Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Less Than 90% : Baseline, Active and Nasal Resistance Phase|Percent sleep time with SAO2 less than 90% was measured overnight by pulse oximetry with a finger probe. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.|Day 1, Day 8, Day 29, Day 30 and Day 31|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.|||Percentage of sleep time||Standard Deviation|Mean
2538220|NCT03105297|Secondary|Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Greater Than 90% : Baseline, Active and Nasal Resistance Phase|Percent sleep time with SAO2 greater than 90% was measured overnight by pulse oximetry with a finger probe. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.|Day 1, Day 8, Day 29, Day 30 and Day 31|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.|||Percentage of sleep time||Standard Deviation|Mean
2538221|NCT03105297|Secondary|Average Oxygen Desaturation During Sleep : Baseline, Active and Nasal Resistance Phase|Oxygen desaturation is the drop in blood's oxygen level per hours of sleep. Average drop in oxygen level during total sleep was measured overnight by pulse oximetry with a finger probe using a computerized system. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.|Day 1, Day 8, Day 29, Day 30 and Day 31|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.|||Percentage of oxygen desaturation||Standard Deviation|Mean
2538222|NCT03105297|Secondary|Mean Arterial Oxygen Saturation (SAO2) During Sleep Time : Baseline, Active and Nasal Resistance Phase|SAO2 in sleep time was measured overnight by pulse oximetry with a finger probe using a computerized system. Mean of the observed SAO2 values during entire sleep time was reported for this endpoint. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.|Day 1, Day 8, Day 29, Day 30 and Day 31|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.|||Percentage of SAO2||Standard Deviation|Mean
2538223|NCT03105297|Secondary|Percentage of Lowest Arterial Oxygen Saturation (SAO2) During Rapid Eye Movement (REM) and Non-rapid Eye Movement (REM) Sleep Stage : Baseline, Active and Nasal Resistance Phase|Arterial oxygen saturation (SAO2) is the fraction of [oxygen]-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the blood. SAO2 in NREM and REM sleep was measured overnight by pulse oximetry with a finger probe using a computerized system. Lowest SAO2 values observed during the NREM and REM sleep were recorded for this endpoint. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.|Day 1, Day 8, Day 29, Day 30 and Day 31|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.|||Percentage of SAO2||Standard Deviation|Mean
2538224|NCT03105297|Secondary|Respiratory Effort Related Arousals (RERA) : Baseline, Active and Nasal Resistance Phase|Respiratory Effort Related Arousal (RERA) was flattening of an inspiratory portion of nasal pressure with increased respiratory effort leading to arousal. The total number of arousals per hour were calculated as RERA. RERA was measured all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.|Day 1, Day 8, Day 29, Day 30 and Day 31|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.|||RERA per hour||Standard Deviation|Mean
2538225|NCT03105297|Secondary|Total Non-rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Sleep : Baseline, Active and Nasal Resistance Phase|Total NREM (N1, 2, and 3) and REM sleep were calculated as the time spent by a participant in the NREM (measured during stable sleep) and REM sleep stages. Total NREM and REM sleep was measured by overnight PSG using a computerized system for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.|Day 1, Day 8, Day 29, Day 30 and Day 31|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.|||Minutes||Standard Deviation|Mean
2538226|NCT03105297|Secondary|Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase|Non-Rapid eye movement (NREM) sleep stage consist of 3 progressively deeper stages of sleep: N1 (transition period from being awake to falling asleep), N2 (where breathing and heart rate began to slow) and N3 (slow wave sleep where body heals and repair itself). Sleep architecture (SA) was measured by the percentage of sleep time spent by the participants in each stage (time spent in each stage to total time spent in NREM, multiplied by 100). SA was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.|Day 1, Day 8, Day 29, Day 30 and Day 31|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.|||Percentage of sleep time||Standard Deviation|Mean
2538227|NCT03105297|Secondary|Arousal Index (AI) : Baseline, Active and Nasal Resistance Phase|Arousal index (AI) is the number of arousals and awakenings, reported as a total number per hour of sleep. AI was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.|Day 1, Day 8, Day 29, Day 30 and Day 31|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.|||Number of arousals per hour||Standard Deviation|Mean
2538228|NCT03105297|Secondary|Sleep Onset Latency (SOL) : Baseline, Active and Nasal Resistance Phase|Sleep onset latency (SOL, a PSG parameter) was measured as the duration from the time when lights were turned off (as the participants attempted to sleep) till the time participant fell asleep. Determination of sleep and awake state was based on Electroencephalography (EEG) and behavioral parameters change. SOL was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.|Day 1, Day 8, Day 29, Day 30 and Day 31|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.|||Minutes||Standard Deviation|Mean
2538229|NCT03105297|Secondary|Sleep Efficiency (SE) : Baseline, Active and Nasal Resistance Phase|Sleep efficiency [SE, a polysomnography (PSG)] was measured as the percentage of total time in bed spent in sleep. It was calculated as the sum of Stage N1, Stage N2, Stage N3, and REM sleep, divided by the total time in bed and multiplied by 100. SE gives an overall sense of how well the participant slept and was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.|Day 1, Day 8, Day 29, Day 30 and Day 31|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.|||Percentage of sleep time||Standard Deviation|Mean
2538230|NCT03105297|Secondary|Total Sleep Time (TST) : Baseline, Active and Nasal Resistance Phase|TST was measured by overnight polysomnography (PSG) using a computerized system. TST was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.|Day 1, Day 8, Day 29, Day 30 and Day 31|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.|||Minutes||Standard Deviation|Mean
2538231|NCT03105297|Secondary|Percentage of Participants With Oro-nasal Breathing Route : Baseline, Active and Nasal Resistance Phase|The Investigator or designee recorded the oro-nasal breathing route during the participant's domiciled sleep visits. Oro-nasal breathing route was observed for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.|Day 1, Day 8, Day 29, Day 30 and Day 31|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.|||Percentage of participants||Standard Deviation|Mean
2538232|NCT03105297|Secondary|Percentage of Participants With Nasal Breathing Route : Baseline, Active and Nasal Resistance Phase|The Investigator or designee recorded the Nasal breathing route during the participant's domiciled sleep visits. Nasal breathing route was observed for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.|Day 1, Day 8, Day 29, Day 30 and Day 31|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.|||Percentage of participants||Standard Deviation|Mean
2538233|NCT03105297|Secondary|Peak Sore Sound Intensity : Baseline, Active and Nasal Resistance Phase|The Investigator or designee recorded the peak snore sound intensity during the participant's domiciled sleep visits. Peak snore sound intensity was recorded for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.|Day 1, Day 8, Day 29, Day 30 and Day 31|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints|||Decibels||Standard Deviation|Mean
2538273|NCT03103919|Primary|Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Amplitude Score|Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.|Baseline (Visit 1/Week 1) to Visit 2 (Week 12)|The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post‑Baseline efficacy measurement.|||Scores on a scale||Standard Error|Least Squares Mean
2538234|NCT03105297|Secondary|Average Snore Sound Intensity : Baseline, Active and Nasal Resistance Phase|The Investigator or designee recorded the average snore sound intensity during the participant's domiciled sleep visits. Average snore sound intensity was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase|Day 1, Day 8, Day 29, Day 30 and Day 31|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.|||Decibels||Standard Deviation|Mean
2538235|NCT03105297|Secondary|Snoring Percent of Sleep Time : Baseline, Active and Nasal Resistance Phase|The Investigator or designee recorded the snoring percent (%) present in sleep time during the participant's domiciled sleep visits. Snoring % was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.|Day 1, Day 8, Day 29, Day 30 and Day 31|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints.|||Percentage of sleep time||Standard Deviation|Mean
2538236|NCT03105297|Secondary|Number of Snores Per Hour : Baseline, Active and Nasal Resistance Phase|The Investigator or designee recorded the number of snores per hour during the participant's domiciled sleep visits. Numbers of snores were recorded for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.|Day 1, Day 8, Day 29, Day 30 and Day 31|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable at specified timepoints|||Number of snores per hour||Standard Deviation|Mean
2538237|NCT03105297|Secondary|Total Epworth Sleepiness Scale Score (ESS) : Active Phase|Participants answered the following question How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? 1. Sitting and reading, 2. Watching TV, 3. Sitting, inactive in a public place (e.g. a theatre or a meeting), 4. As a passenger in a car for an hour without a break, 5. Lying down to rest in the afternoon when circumstances permit, 6. Sitting and talking to someone, 7. Sitting quietly after a lunch without alcohol, and 8. In a car, while stopped for a few minutes in the traffic. Use the following scale to choose the most appropriate number for each situation: 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 3 = high chance of dozing. Total ESS was calculated as the sum of all the individual scores observed for the above mentioned situations. The possible range for total ESS was 0-24. A lower total ESS indicates better sleep.|Day 29|"Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, N signifies participants who were evaluable for this outcome measure."|||Score on scale||Standard Deviation|Mean
2538238|NCT03105297|Secondary|Global Self Assessment Score : Active Phase|On Day 29, prior to sleep, participants were asked to rate their overall experience with the strip as compared to before they enrolled in the study: ease of breathing, staying asleep, falling back to sleep, waking up too early, number of awakenings, falling asleep, sleep quality, sleep depth, dry mouth upon awakening, morning headache, nocturia (waking up to urinate), feeling refreshed in the morning. Experience was rated on scale of -2 to 2 were: -2 = Much worse, -1 = Somewhat worse, 0 = No change, 1 = Somewhat improve, 2 = Much improved (higher score indicated improvement).|Day 29|Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number analyzed signifies participants who were evaluable for the specified categories.|||Score on a scale||Standard Deviation|Mean
2538239|NCT03105297|Secondary|Total Score of Composite Functional Outcomes of Sleep Questionnaire (FOSQ) : Active Phase|The FOSQ was 30-item, validated psychometric instrument that assessed the impact of disorders of excessive sleepiness on functional outcomes relevant to daily behaviors and quality of life (QoL). The responses to the questionnaire were grouped according to five factors for analysis: 1) Activity Level, 2) Vigilance, 3) Intimacy and Sexual Relationships, 4) General Productivity and 5) Social Outcome. Participant used a scale of 0 to 4 to score each question of FOSQ which then grouped in above factors (where 0= I don't do this activity for other reasons, 1= Yes, extreme difficulty, 2= Yes, moderate difficulty, 3= Yes, a little difficulty, and 4= No difficulty). Total score of composite FOSQ was the sum of scores obtained on all 30 questions of the questionnaire. The possible range for the total score of composite FOSQ was from 0-120. A higher total score of composite FOSQ indicates better QoL of the participant.|Day 29|"Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, N signifies participants who were evaluable for this outcome measure."|||Score on a scale||Standard Deviation|Mean
2538240|NCT03105297|Primary|Nasal Resistance by Posterior Rhinomanometry : Baseline Phase|Nasal resistance was measured on Day 1, by a modified method of posterior rhinomanometry in awake and seated position. Using posterior rhinomanometry, the transnasal pressure difference was measured between the nasopharynx and the external nares. The technique measures the difference in transnasal pressure that drives the flow of air through the nasal cavities.|Day 1|"Safety population included all participants to whom the study treatment was dispensed. Here, N signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for the specified categories."|||cmH2O/liter/seconds||Standard Deviation|Mean
2538241|NCT03105297|Primary|Volume at Minimum Cross-sectional Area 1 (MCA1) : Baseline Phase|Volume of the first 3 cm of the nasal cavity behind the nostril (0-3 cm2). Volume at MCA1 was measured with an Acoustic Rhinometer at Day 1 before and after Nasal dilator strip application.|Day 1|"Safety population included all participants to whom the study treatment was dispensed. Here, N signifies participants who were evaluable for this outcome measure."|||cm^3||Standard Deviation|Mean
2538242|NCT03105297|Primary|Area at Minimum Cross Sectional Area 1 (MCA1) : Baseline Phase|Minimum cross sectional area 1 (MCA1) in the first 3 cm of the nasal cavity behind the nostril (0-3 cm), considered to be the area of the nasal valve and the distance from the nares of this restriction. MCA 1 was measured with an Acoustic Rhinometer at Day 1 (baseline phase) before and after Nasal dilator strip application.|Day 1|"Safety population included all participants to whom the study treatment was dispensed. Here, N signifies participants who were evaluable for this outcome measure."|||cm^2||Standard Deviation|Mean
2538243|NCT03105297|Primary|Nasal Resistance in Sleeping State : Nasal Resistance Phase|Nasal resistance of the participants with and without strip was measured in sleeping state using a nasal mask and a flow meter to obtain a trans-nasal pressure difference and nasal flow by continuous recording over the 2 nights [on Day 30 (Visit 5) and Day 31 (Visit 6), cumulatively], of the nasal resistance phase.|upto 2 days|"Per protocol population included all participants who fully complied with all study procedures and restrictions. Here, number of participants analyzed N signifies participants who were evaluable for this outcome measure and number analyzed signifies participants who were evaluable for the specified categories."|||Centimeter (cm) H2O/liter/sec||Standard Deviation|Mean
2538244|NCT03104985|Primary|Number of Participants With Trophic Ulcer Healing|Number of participants with ulcer epithelialization was counted in both groups. Trophic ulcer healing in 6 months occurred in larger number of participants of conventional therapy and combined LLLT group.|6 months follow up||||Participants|||Count of Participants
2538245|NCT03104816|Primary|Postoperative Opioid Use|Determine the impact of administering a supplemental non-opioid analgesic drug such as IV/oral acetaminophen on total opioid dose administered over the perioperative period.|Within 24 hours after surgery||||mg||Standard Deviation|Mean
2538246|NCT03104738|Secondary|Mean 24-hour Glucose Postoperatively||Anesthesia stop time - 24 hours postoperatively||||mg/dl||Standard Deviation|Mean
2538247|NCT03104738|Secondary|Incidence of Surgical Delay or Cancellation Due to Hyperglycemia||Hospital arrival - Surgery start date/time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases||||Participants|||Count of Participants
2538248|NCT03104738|Secondary|Incidence of Hypoglycemia in the PACU to 24 Hours Post-operatively|Capillary or arterial/venous blood glucose level <80 mg/dl|Anesthesia stop time - 24 hours postoperatively.||||Participants|||Count of Participants
2538249|NCT03104738|Secondary|Incidence of Symptomatic Hypoglycemia Requiring Treatment in the PACU to 24 Hours Post-operatively|Capillary or arterial/venous blood glucose level <70 mg/dl|Anesthesia stop time - 24 hours postoperatively.||||Participants|||Count of Participants
2538250|NCT03104738|Secondary|Incidence of Hyperglycemia in the Post-anesthesia Care Unit (PACU) to 24 Hours Post-operatively|Capillary or arterial/venous blood glucose level >179 mg/dl|Anesthesia stop time - 24 hours postoperatively.||||Participants|||Count of Participants
2538251|NCT03104738|Secondary|Incidence of Patients Requiring Initiation of Perioperative IV Insulin Drip||Hospital arrival - 24 hours postoperatively.||||Participants|||Count of Participants
2538252|NCT03104738|Secondary|Incidence of Intraoperative Hyperglycemia|Capillary or arterial/venous blood glucose level >179 mg/dl|Anesthesia start time - Anesthesia stop time. The time period did not exceed 10 hours, considering type of surgeries or procedures.|"Out of 20 subjects in the 50% reduction, intraoperative blood glucose level for was not measured on 1 subject; therefore, only 19 subjects were analyzed for this outcome.~Out of 20 subjects in the 25% reduction, intraoperative blood glucose level for was not measured on 3 subject; therefore, only 17 subjects were analyzed for this outcome."|||Participants|||Count of Participants
2538253|NCT03104738|Secondary|Incidence of Preoperative Hyperglycemia|Capillary blood glucose level >179 mg/dl|Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases||||Participants|||Count of Participants
2538254|NCT03104738|Secondary|Incidence of Preoperative Hypoglycemia Requiring Ingestion of Juice Prior to Arrival to the Hospital|Capillary blood glucose level <70 mg/dl|Basal insulin dose administration the evening before surgery - Hospital arrival the morning of the surgery. The time period did not exceed 12 hours, considering a fasting period up to 8 hours and a preoperative period up to 4 hours.||||Participants|||Count of Participants
2538255|NCT03104738|Secondary|Incidence of Preoperative Hypoglycemia|Capillary blood glucose level <80 mg/dl|Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases.||||Participants|||Count of Participants
2538256|NCT03104738|Primary|Pre-operative Fasting Blood Glucose, as Measured by Standardized Point of Care Capillary Blood Glucose (CBG) Device in the Pre-op Holding Area.|Capillary blood glucose before surgery, considering a fasting period up to 8 hours prior fasting blood glucose|Hospital arrival - Anesthesia start time. The time period did not exceed 4 hours, considering that surgeries were scheduled to be morning cases.||||mg/dl||Standard Deviation|Mean
2538257|NCT03104647|Secondary|Number of Participants With Any Adverse Event Occurring During the Study|Safety measure - The number of participants with any adverse event reported by the subject or observed by the investigator/clinician during the study will be recorded.|through study completion, an average of 2 weeks||||participants|||Number
2538258|NCT03104647|Primary|Number of VRP-Clinic Neck Movements That the Assessing Clinician Recognizes as Rehabilitation Movements|"The movements are recorded on video and sent to clinicians for evaluation after the session is completed.~The movements are then evaluated by the clinicians according to a predetermined list."|Up to 2 weeks after the session|Each subject performed 8 movements and repeated them twice. Overall, 160 movements were performed by 20 subjects and repeated twice. The clinicians recognized all the movements and determined them as rehabilitation movements.|||Movements|Movements||Number
2538259|NCT03104322|Secondary|Patient-reported Forced Vital Capacity (FVC)|Forced vital capacity recorded via patientMpower platform daily|8 weeks|All entered patients who provided home spirometry data|||L||Full Range|Mean
2538260|NCT03104322|Secondary|Patient-reported Exercise Performance|Activity (steps/day) recorded via FitBit or patient's phone and transmitted to patientMpower platform|8 weeks|No data available for analysis due to technical issues (no patient used a FitBit or mobile device with built-in accelerometer)||||||
2538274|NCT03103919|Primary|Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Postural Tremor Score|Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.|Baseline (Visit 1/Week 1) to Visit 2 (Week 12)|The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post‑Baseline efficacy measurement.|||Scores on a scale||Standard Error|Least Squares Mean
2538414|NCT03100058|Secondary|Change From Baseline in Fasting Lipid Profile (Lipoproteins)|Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48|Baseline, Week 24, Week 24 to Week 48 (Epoch 4)|Full Analysis Set|||g/L||95% Confidence Interval|Mean
2538261|NCT03104322|Secondary|Idiopathic Pulmonary Fibrosis Patient Reported Outcome Measure (IPF-PROM)|12-item questionnaire with 4 domains (psychological experience of dyspnoea, physical experience of dyspnoea, emotional well-being, energy levels). 3 questions/domain asking frequency of symptom or its impact in the time interval since last response. Four possible responses to each question: none of the time/some of the time/most of the time/all of the time. Numerical score assigned to each response 1/2/3/4 (respectively). Impact on domain characterised by mean score for each of 3 questions in that domain. One question on overall quality of life with responses: excellent/good/fair/poor/very poor. Numerical score assigned to each response 1/2/3/4/5 respectively. Low score better outcome; high score worse outcome (for all responses).|Baseline visit|patients who provided at least 1 IPF-PROM; insufficient data for analysis of time trends; Baseline values reported|||score on a scale||Full Range|Mean
2538262|NCT03104322|Secondary|Medication Compliance (Days Medication Taken/Observation Period Days)|Compliance recorded by patient via patientMpower platform daily|8 weeks|Patients did not record medication compliance during study timeframe.||||||
2538263|NCT03104322|Primary|Acceptability of patientMpower Platform From Patient & Healthcare Professional Perspective|"Questionnaire-based assessment of response to questions: [pMp = patientMpower platform]~instructions for using pMp were clear~pMp helped me take the correct dose medicines~pMp helped me to take my medicines at the correct time~pMp helped me to reach my personal exercise goal~pMp helped me to walk further~pMp gave me a greater sense of control~useful to be able to record the impact of lung fibrosis on QoL~pMp encouraged me to look at the informational videos~preference for using pMp~difficulty in using pMp~effect of pMp on impact on daily life~tiring/irritating to use pMp~want to continue using pMp after study~would recommend pMp to others Possible responses Q1-8, Q12: strongly agree/agree/disagree/strongly disagree Q9: yes/no preference/no Q10: very easy/easy/difficult/very difficult Q11: positive/negative/open text Q13,14: yes/no"|single measurement at 8 weeks|Patients who completed study and provided response to questionnaire|||Participants|||Count of Participants
2538264|NCT03103919|Secondary|Number of Subjects With Any Adverse Events During the Course of the Study|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Visit 1 (Week 1) to Visit 2 (Week 12)|The Safety Set (SS) included all subjects who received at least 1 dose of Neupro.|||Participants|||Count of Participants
2538265|NCT03103919|Primary|Number of Subjects Who Discontinued the Treatment With Neupro During the Course of the Study|Number of subjects who discontinued Neupro Treatment were recorded.|Visit 1 (Week 1) to Visit 2 (Week 12)|The Safety Set (SS) included all subjects who received at least 1 dose of Neupro.|||Participants|||Count of Participants
2538266|NCT03103919|Primary|Number of Neupro Dose Changes During the Study|Dose adjustments during study are performed per standard of care.|Visit 1 (Week 1) to Visit 2 (Week 12)|The Safety Set (SS) included all subjects who received at least 1 dose of Neupro.|||dose changes||Standard Deviation|Mean
2538267|NCT03103919|Primary|Neupro Dose Per 24h at Visit 2 (Week 12)|Daily dose of study medication taken at respective visit.|Visit 2 (Week 12)|The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post‑Baseline efficacy measurement.|||mg/24 hr||Standard Deviation|Mean
2538268|NCT03103919|Primary|Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Dyskinesia Score|Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.|Baseline (Visit 1/Week 1) to Visit 2 (Week 12)|The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post‑Baseline efficacy measurement.|||Scores on a scale||Standard Error|Least Squares Mean
2538269|NCT03103919|Primary|Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Amplitude Score|Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.|Baseline (Visit 1/Week 1) to Visit 2 (Week 12)|The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post‑Baseline efficacy measurement.|||Scores on a scale||Standard Error|Least Squares Mean
2538270|NCT03103919|Primary|Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rapid Alternating Movement Speed Score|Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.|Baseline (Visit 1/Week 1) to Visit 2 (Week 12)|The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post‑Baseline efficacy measurement.|||Scores on a scale||Standard Error|Least Squares Mean
2538271|NCT03103919|Primary|Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Amplitude Score|Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.|Baseline (Visit 1/Week 1) to Visit 2 (Week 12)|The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post‑Baseline efficacy measurement.|||Scores on a scale||Standard Error|Least Squares Mean
2538272|NCT03103919|Primary|Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Hand Grasp Speed Score|Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.|Baseline (Visit 1/Week 1) to Visit 2 (Week 12)|The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post‑Baseline efficacy measurement.|||Scores on a scale||Standard Error|Least Squares Mean
2538294|NCT03102879|Secondary|Change in Pulpal Response|Change in pulpal response (period 1 year) will be assessed through response to sensitivity tests (cold, hot and electrical test) in teeth treated with regenerative procedure and conventional endodontic treatment during time.|baseline, 6 months, 12 months||||Participants|||Count of Participants
2538275|NCT03103919|Primary|Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Averaged Finger Tapping Speed and Resting Tremor Scores|Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. The finger tapping speed scores and resting tremor scores were averaged and provided as one score ranging from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.|Baseline (Visit 1/Week 1) to Visit 2 (Week 12)|The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post‑Baseline efficacy measurement.|||Scores on a scale||Standard Error|Least Squares Mean
2538276|NCT03103919|Primary|Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Rest Tremor Score|Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.|Baseline (Visit 1/Week 1) to Visit 2 (Week 12)|The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post‑Baseline efficacy measurement.|||Scores on a scale||Standard Error|Least Squares Mean
2538277|NCT03103919|Primary|Change From Baseline to Visit 2 in Kinesia-ONE™ Variable: Finger Tapping Speed Score|Kinesia-ONE™ measures were averaged from triplicate repeated assessments at a measurement point. Kinesia-ONE scores ranged from 0 to 4 (where 0 is normal and 4 represents severe abnormalities), with negative change from Baseline scores indicating improvement in disease symptoms.|Baseline (Visit 1/Week 1) to Visit 2 (Week 12)|The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post‑Baseline efficacy measurement.|||Scores on scale||Standard Error|Least Squares Mean
2538278|NCT03103919|Primary|Change From Baseline to Visit 2 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Score|UPDRS Part III has 27 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Each of the 27 items in the UPDRS part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The motor score ranges from 0 to 108, where the maximum score indicates the worse condition. A negative value in change in Unified Parkinson's Disease Rating Scale indicates improvement, whereas a positive value indicates worsening of disease.|Baseline (Visit 1/Week 1) to Visit 2 (Week 12/ 3 months after start of treatment with Neupro)|The Full Analysis Set (FAS) included all subjects who had at least 1 valid Baseline and at least 1 valid post‑Baseline efficacy measurement.|||Scores on a scale||Standard Error|Least Squares Mean
2538279|NCT03103906|Other Pre-specified|Number of Participants With Global Self-Assessment of Satisfaction Score|Participants rated the level of satisfaction with the post-procedure skin care regimen to which they were randomized using scale as follows: 0 (Very satisfied), 1 (Satisfied), 2 (Poorly satisfied), 3 (Not at all satisfied).|14 days after completion of the facial peel procedure|ITT population included all randomized participants.|||Participants|||Count of Participants
2538280|NCT03103906|Secondary|Change From Baseline in Corneometer Measurements|Corneometry was used to measure moisture content of stratum corneum using corneometer. The corneometer probe was placed in contact with the skin of the participant's test site for 1-2 s per measurement. The corneometer measurements were performed in triplicate at the left cheek (below the cheekbone, between the nose and ear) with the participant lying horizontally, on their back. Corneometer values were measured at 180 mins, 360 mins, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure to evaluate the impact of twice-daily application of the investigational products on skin moisturization compared to the use of no test product. An increase in Corneometer values corresponds to skin-moisturizing effect.|At baseline (60 mins. post procedure but prior to any test product application) and 180 mins, 360 mins, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure|ITT population included all randomized participants. Number of participants analyzed are the part of ITT population analyzed for this outcome at specific time points.|||corneometer units||Standard Deviation|Mean
2538281|NCT03103906|Secondary|Change From Baseline in Trans-epidermal Water Loss (TEWL)|Trans-epidermal water loss (TEWL) measurement was performed by evaporimetry with a Tewameter to assess skin barrier function. Measurements was done in triplicate on the left cheek (below the cheekbone between the nose and ear). TEWL measurements was performed the participant lying horizontally, on their back, so that the chimney of the Tewameter probe was aligned vertically.|At baseline (60 mins. post procedure but prior to any test product application) and 180 mins, 360 mins, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure|Intent-to-treat (ITT) population included all randomized participants. Number of participants analyzed are the part of ITT population analyzed for this outcome at specific time points.|||gram per square meter per hour (g/m2/hr)||Standard Deviation|Mean
2538282|NCT03103906|Secondary|Change From Baseline in Individual Participant Self-Assessment Scores for Pain, Stinging/Burning, Itching, Tightness, Redness and Dryness|Participant Self-Assessment was conducted by participants reflective of their skin condition at the time of evaluation. Participants scored following signs/symptom: pain, stinging/burning, itching, tightness, redness and dryness on scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Higher score represents less tolerance to product applied.|At baseline (60 minutes. post procedure but prior to any test product application) and 180 minutes, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure|Safety population included all participants with at least one application of product (i.e. test product for participants in Group 1 or sunscreen for participants in Group 2). Number of participants analyzed are the part of safety population evaluated for this outcome at specific time points.|||score on a scale||Standard Deviation|Mean
2538283|NCT03103906|Secondary|Change From Baseline in Total Score of Participant Self-Assessment Scores|Participant Self-Assessment was conducted by participants reflective of their skin condition at the time of evaluation. Participants scored following signs/symptom: pain, stinging/burning, itching, tightness, redness and dryness on scale of 0 to 3. (0= None, 1= Mild, 2= Moderate, and 3= Severe). Total score ranges as 0 to 18, higher score represents less tolerance to product applied.|At baseline (60 minutes. post procedure but prior to any test product application) and 180 minutes, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure|Safety population included all participants with at least one application of product (i.e. test product for participants in Group 1 or sunscreen for participants in Group 2). Number of participants analyzed are the part of safety population evaluated for this outcome at specific time points.|||score on a scale||Standard Deviation|Mean
2538284|NCT03103906|Secondary|Change From Baseline in Individual Dermatologist Assessment Scores of Erythema, Dryness, Desquamation and Edema|Participants scored for all domains of Dermatologist Assessment Score using scale of 0 to 3. Erythema (0=None-No evidence of erythema present, 1=Mild-Slight red coloration, 2=Moderate-Definite redness, 3=Severe-Marked erythema, bright red to dusky dark red), Dryness (0=None-No dryness, 1=Mild-Barely perceptible, fine scales or flakes present to limited areas of the test site, 2=Moderate-Fine scales or flakes generalized to all areas of the test site, 3=Severe -Scaling & peeling of skin over all areas of the test site), Desquamation (0=None-No evidence of desquamation/peeling, 1=Mild-Barely perceptible scaling; evident only on scratching, 2=Moderate-Minimal scaling, adherent to the skin, 3=Severe -Moderate scaling, loosely adherent to the skin & easily removable), Edema (0=None-No edema present, 1=Mild-Barely perceptible edema present, 2=Moderate-Definite edema present, 3=Severe Marked/pronounced edema present). Higher scores represent less local tolerance.|At baseline (60 minutes. post procedure but prior to any test product application) and 180 minutes, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure|Safety population included all participants with at least one application of product (i.e. test product for participants in Group 1 or sunscreen for participants in Group 2). Number of participants analyzed are the part of safety population evaluated for this outcome at specific time points.|||score on a scale||Standard Deviation|Mean
2538285|NCT03103906|Secondary|Change From Baseline in Total Score of Dermatologist Assessment Score|Participants scored for all domains of Dermatologist Assessment Score using scale of 0 to 3. Erythema (0=None-No evidence of erythema present, 1=Mild-Slight red coloration, 2=Moderate-Definite redness, 3=Severe-Marked erythema, bright red to dusky dark red), Dryness (0=None-No dryness, 1=Mild-Barely perceptible, fine scales or flakes present to limited areas of the test site, 2=Moderate-Fine scales or flakes generalized to all areas of the test site, 3=Severe -Scaling & peeling of skin over all areas of the test site), Desquamation (0=None-No evidence of desquamation/peeling, 1=Mild-Barely perceptible scaling; evident only on scratching, 2=Moderate-Minimal scaling, adherent to the skin, 3=Severe -Moderate scaling, loosely adherent to the skin & easily removable), Edema (0=None-No edema present, 1=Mild-Barely perceptible edema present, 2=Moderate-Definite edema present, 3=Severe Marked/pronounced edema present). Total score as 0 to 12, higher scores represent less local tolerance.|At baseline (60 minutes post procedure but prior to any test product application), 180 minutes, 1 day, 2 days, 3 days, 7 days and 14 days after completion of the facial peel procedure|Safety population included all participants with at least one application of product (i.e. test product for participants in Group 1 or sunscreen for participants in Group 2). Number of participants analyzed are the part of safety population evaluated for this outcome at specific time points.|||score on a scale||Standard Deviation|Mean
2538286|NCT03103906|Primary|Number of Participants With Evaluator (Dermatologist) Global Assessment (EGA) Score for Well Tolerance of Product 14 Days Post-Procedure|The Dermatologist assessed the local tolerance of the post-procedure skin care regimen in context of the expected effects of the procedure for each participant using the scale below: 0 - Product regimen was well tolerated (No clinically significant worsening of the expected signs/symptoms of the procedure. No new signs/symptoms manifest during product use) and 1 - Product regimen was not well tolerated (Clear, clinically relevant worsening of the severity or frequency of expected signs/symptoms of the procedure and/or any occurrence of new, unexpected signs/symptoms during product use). The Dermatologist drawn assessment on the total set of clinical and participant self-assessment data for each participant.|14 days after completion of the facial peel procedure|Safety population included all participants with at least one application of product (i.e. test product for participants in Group 1 or sunscreen for participants in Group 2). Number of participants analyzed are the part of safety population analyzed for this outcome 14 days post-procedure.|||Participants|||Count of Participants
2538287|NCT03103061|Secondary|Diagnostic Accuracy Using Quantitative Objective Image Quality Assessment|Assess the diagnostic accuracy of CT perfusion imaging compared to either SPECT or invasive angiography.|Immediately following CT perfusion imaging.||||Percent|||Number
2538288|NCT03103061|Primary|Number of Treatment-related Adverse Events|"Demonstrate that CTA with stress and rest perfusion imaging using Lexiscan as the coronary vasodilator will be safe and well tolerated.~This outcome measure data value represents the number of adverse events that occurred during this study."|30 days +/- 3 days||||Adverse events|||Number
2538289|NCT03102918|Primary|Self-report Instruments to Measure Cannabis Use|Self-reported cannabis inhalations per day during Week 6 as reported by Timeline Followback|During Week 6|One subject in the Cannabidiol arm was withdrawn from the study before Week 6 due to poor medication adherence.|||Inhalations of Cannabis Per Day||Standard Deviation|Mean
2538290|NCT03102879|Secondary|Pulp Regeneration|"To describe the pulp regeneration by means of vitality test using Doppler laser flowmetry (LDF) in a period of 1 year in permanent teeth with mature apex and apical lesion treated with a regenerative endodontic procedure.~The vitality of the teeth was measured by LDF and the perfusion units (PU) percentage of the tooth under study was determined with respect to a healthy control tooth with similar anatomical characteristics from the same patient."|baseline, 6 months, 12 months|This outcome was not measured in conventional treatment group due to the nature of the filling material, which does not promote revitalization of the pulp.|||% PU in time in relation to controltooth||Inter-Quartile Range|Median
2538291|NCT03102879|Secondary|Numbers of Participants With Adverse Event|To describe adverse events in a period of 1 year in permanent teeth with mature apex and apical lesion, operated with a regenerative endodontic procedure and conventional endodontic therapy.|6 months, 12 months||||Participants|||Count of Participants
2538292|NCT03102879|Secondary|Pain to Percussion|"To compare pain to percussion in a period of 1 year in permanent teeth with mature apex and apical lesion, treated with a regenerative endodontic procedure and conventional endodontic therapy.~This will be monitored 6 and 12 months after the procedure is completed.~Pain to percussion positive: The tooth is tenderness when is softly tapped with handle end of a dental mirror at examination time.~Pain to percussion negative: The tooth is not tenderness when is softly tapped with handle end of a dental mirror at examination time."|baseline, 6 months, 12 months||||Participants|||Count of Participants
2538293|NCT03102879|Secondary|Change in Apical Lesion Size|Change in apical lesion size will be evaluated by cone beam tomography 6 and 12 months after intervention is completed.|baseline, 6 months, 12 months||||milimeters||Inter-Quartile Range|Median
2545593|NCT02940327|Primary|CD16/41|Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.|24 hours after ECMO commencement||||percentage change||Standard Deviation|Mean
2538295|NCT03102879|Primary|Number of Participats Showing Efficacy (Functionality)|Efficacy (functionality) was defined when one year after the intervention, the treated tooth remains in the mouth, without pain to percussion test and with apical bone lesion of equal size in the three senses of space or a decrease in some of them or no more than 0.1 mm increase of one of them.|12 months||||Participants|||Count of Participants
2538296|NCT03102762|Secondary|Intra-vaginal Latency Time After Treatment|Measurement of the duration of intercourse from intromission to ejaculation after treatment.|6 and 12 weeks after injection.|One patient was dropped out from the treatment group after 2 weeks injection.|||Participants|||Count of Participants
2538297|NCT03102762|Secondary|Intra-vaginal Latency Time After Treatment|Measurement of the duration of intercourse from intromission to ejaculation after treatment.|2 weeks after injection.||||Participants|||Count of Participants
2538298|NCT03102762|Secondary|Intra-vaginal Latency Time Before Treatment|Measurement of the duration of intercourse from intromission to ejaculation before treatment.|Baseline||||Participants|||Count of Participants
2538299|NCT03102762|Secondary|Penile Size After Treatment|Measurement of penile length after treatment.|6 and 12 weeks after injection.|One patient was dropped out from the treatment group after 2 weeks injection.|||cm||Standard Deviation|Mean
2538300|NCT03102762|Secondary|Penile Size After Treatment|Measurement of penile length after treatment.|2 weeks after injection.||||cm||Standard Deviation|Mean
2538301|NCT03102762|Secondary|Penile Size Before Treatment|"Measurement of penile length before treatment:~Flaccid, stretched and erect penile length."|Baseline||||cm||Standard Deviation|Mean
2538302|NCT03102762|Secondary|SHIM Score After Treatment|"Assessment of the Sexual Health Inventory for men (SHIM) questionnaire after 6 and 12 weeks of both groups. It is a questionnaire that helps to asses if the patient has erectile dysfunction (ED) and to assess its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED.~Minimum value is 1, Maximum value is 25, the higher the score the better is the outcome."|6 and 12 weeks after injection.|One patient was dropped out after 2 weeks of injection from the BTX-A Group|||score on a scale||Standard Deviation|Mean
2538303|NCT03102762|Secondary|SHIM Score After Treatment|"Assessment of the Sexual Health Inventory for men (SHIM) questionnaire after treatment for both groups. It is a questionnaire that helps to asses if the patient has erectile dysfunction (ED) and to assess its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED.~Minimum value is 1, Maximum value is 25, the higher the score the better is the outcome."|2 weeks after injection.||||score on a scale||Standard Deviation|Mean
2538304|NCT03102762|Secondary|SHIM Score Before Treatment|Assessment of the Sexual Health Inventory for men (SHIM) questionnaire before treatment for both groups. It is a questionnaire that helps asses if the patient has erectile dysfunction (ED) and assesses its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED.|Baseline||||score on a scale||Standard Deviation|Mean
2538305|NCT03102762|Primary|Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV After Treatment|Cavernosal artery mean peak systolic velocity (PSV) after treatment, on color Doppler examination, in the patient and control groups.|2 weeks||||cm/sec||Standard Deviation|Mean
2538306|NCT03102762|Primary|Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV Before Treatment|Baseline mean Peak systolic velocity (PSV) in the Cavernosal arteries, on color Doppler examination, in the patient and control groups.|Baseline||||cm/sec||Standard Deviation|Mean
2538307|NCT03102411|Secondary|Self-reported Functional GI Disorders|Percentages of self-reported functional GI disorders ( a subject can check more than one answer - Acid reflux (GERD), Irritable bowel syndrome (IBS), Celiac disease, Inflammatory bowel disease - Crohn's or Ulcerative Colitis, Diverticulities, Gastroparesis, Leaky gut, small intestinal bacterial overgrowth (SIBO), None of the above)|During the past 3 months before the survey||||Participants|||Count of Participants
2538308|NCT03102411|Primary|Most Common Triggers for Food-related GI Symptoms (Top 5)|Percentages for foods chosen as triggers ( a subject can check more than one answer - Bread, Oats, Chili, Corn, Onion, Garlic, Beans, Chocolate, Fried or greasy foods, Eggs, Soy, Red meat, Fish or shellfish, Dairy products, Nuts and seeds, Apples, Bananas, Citrus fruit, Alcohol, Coffee, Carbonated drinks, Sugar-free gum)|During the past 3 months before the survey||||Participants|||Count of Participants
2538309|NCT03102190|Primary|Number of Participants With Dose Limiting Toxicity|Dose Limiting Toxicity will be defined as a development of 2nd or 3rd degree heart block as measured by an EKG. (Phase Ib primary outcome)|1-8 weeks||||Participants|||Count of Participants
2538310|NCT03102034|Secondary|Frequency of Mucosal Antibody Responses to Vaccine|Determined from nasal wash samples. Reliably quantifying RSV specific antibodies in dilute nasal washes and SAM strips continues to be difficult. We are currently upgrading to a next-generation assay reader with superior sensitivity, and we have improved a DELFIA assay. Due to these challenges, the final results are not available at this time. The results will be posted when available, after passing quality assurance and control reviews at the testing laboratory and at the data management center.|Measured at Day 0, 28 and 56||2020-12-31|12/2020||||
2538311|NCT03102034|Secondary|Number of Participants With B Cell Responses to Vaccine|A B cell response to vaccine is indicated by a greater than or equal to 4-fold change in serum antibody titers to RSV F glycoprotein between the pre- and post-inoculation time points.|Measured at day 0 and Day 56|All participants who received inoculation were included.|||Participants|||Count of Participants
2538312|NCT03102034|Secondary|Magnitude of Serum RSV-neutralizing Antibody Responses in the Vaccine and Placebo Recipients Who Experienced Natural Infection With wt RSV During the Subsequent RSV Season.|Only participants who had RSV detected in nasal washes or a greater than or equal to 4-fold rise in serum antibodies during the subsequent RSV season were included. RSV-neutralizing antibody titers were measured pre- and post-RSV surveillance season.|Measured through participant's last study visit, up to a total of 6 to 13 months depending on when participants enrolled in the study|Only participants who had RSV detected in nasal washes or a greater than or equal to 4-fold rise in serum antibodies during the subsequent RSV season were included.|||log 2 titers||Inter-Quartile Range|Median
2538327|NCT03101371|Secondary|Number of Patients That Used Antibiotics at the Time of Surgery and Post-surgery|Participants were monitored for up to 2 weeks. This is the number of participants that used any antibiotic during surgery and post-surgery.|Day 14 (+/- 2 days)||||Participants|||Count of Participants
2538313|NCT03102034|Secondary|Number of Participants Who Had Symptomatic, Medically Attended Respiratory and Febrile Illness, Among Those Who Experienced Natural Infection With wt RSV During the Subsequent RSV Season|The number of participants who had RSV-associated, medically attended, acute respiratory illness (RSV-MAARI) or RSV-associated, medically attended, acute lower respiratory illness (RSV-MAALRI) among those who had RSV detected in nasal washes or greater than or equal to 4 fold rise in serum antibodies during the subsequent RSV season were presented.|Measured from November 1st through participant's post-RSV season surveillance visit|Only participants who had RSV detected in nasal washes or greater than or equal to 4 fold rise in serum antibodies during the subsequent RSV season were included.|||Participants|||Count of Participants
2538314|NCT03102034|Primary|Serum Antibody Responses to RSV F Glycoprotein as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)|Immunogenicity was assessed at approximately 2 months post-inoculation (Study Day 56).|Measured at Day 56|Study participants who received inoculation were included.|||log 2 titers||Inter-Quartile Range|Median
2538315|NCT03102034|Primary|Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titer|Immunogenicity was assessed pre-inoculation, and at approximately 2 months post-inoculation (Study Day 56). Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.|Measured at Day 0 and Day 56|Study participants who received inoculation were included.|||Participants|||Count of Participants
2538316|NCT03102034|Primary|Duration of Vaccine Virus Shedding in Nasal Washes|Determined separately by a) culture and b) reverse transcription polymerase chain reaction (RT-PCR)|Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28. Last day positive is reported.|Only participants who met the definition of infection with vaccine virus were included.|||days||Inter-Quartile Range|Median
2538317|NCT03102034|Primary|Peak Titer of Vaccine Virus Shed|This is the highest value per participant of the titer of vaccine virus shed. It was measured by culture. Only participants who met the definition of infection with vaccine virus were included.|Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28|Only participants who met the definition of infection with vaccine virus were included.|||log10 PFU/mL||Inter-Quartile Range|Median
2538318|NCT03102034|Primary|Number of Participants Infected With RSV Vaccine Virus|Defined as 1) vaccine virus identified in a nasal wash from Study Day 0-28 (a binary outcome based on nasal washes) and/or 2) greater than or equal to 4-fold rise in RSV-neutralizing antibody titer from Study Day 0 and 56.|Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28 for nasal washes, and at Days 0, 56 for serum RSV-neutralizing antibodies|Study participants who received inoculation were included.|||Participants|||Count of Participants
2538319|NCT03102034|Primary|Number of Participants With Serious Adverse Events (SAEs)|"A Serious Adverse Event (SAE) was an AE, whether considered related to the study product or not, that:~Resulted in death during the period of protocol-defined surveillance~Was life threatening: defined as an event in which the patient was at immediate risk of death at the time of the event; it did not refer to an event that hypothetically might have caused death were it more severe~Required inpatient hospitalization (or prolongation of existing hospitalization): defined as at least an overnight stay in the hospital or emergency ward for treatment that would have been inappropriate if administered in the outpatient setting~Resulted in a persistent or significant disability/incapacity~Was a congenital anomaly or birth defect~Was an important medical event that might not be immediately life threatening or result in death or hospitalization but might jeopardize the patient or might require intervention to prevent one of the outcomes listed above."|Measured from Day 0 through Day 56|Study participants who received inoculation were included.|||Participants|||Count of Participants
2538320|NCT03102034|Primary|Number of Participants With Unsolicited AEs by Grade|Unsolicited adverse events were other events, not included in the solicited AEs. The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each unsolicited AE category, and that was in the line corresponding to the highest grade adverse event they had in that category. AE grading (Grade 1- mild to Grade 4-life-threatening) was done by DAIDS AE Grading table v2.0 (see References).|Measured from Day 0 through Day 28|Study participants who received inoculation were included.|||Participants|||Count of Participants
2538321|NCT03102034|Primary|Number of Participants With Solicited Adverse Events (AEs) by Grade|Solicited adverse events included fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI). The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that was in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 3 and Table 4 in the protocol document.|Measured from Day 0 through Day 28|Study participants who received inoculation were included.|||Participants|||Count of Participants
2538322|NCT03101462|Primary|Hemagglutinin Immunoglobulin A (IgA) Responses|Hemagglutinin (HA) specific nasal wash secretory immunoglobulin A (IgA) of serum reactivity with HA bound to ELISA plates.|Day 7||||Fold change||Standard Error|Mean
2538323|NCT03101462|Primary|Secretory Immunoglobulin A (IgA) Responses|Influenza virus strain-specific nasal wash secretory immunoglobulin A (IgA) titers by ELISA was measured|Day 0 and Day 45|For IIV group, 18 subjects completed Visit 03. For LAIV group, 18 subjects completed Visit 03.|||Titers||95% Confidence Interval|Median
2538324|NCT03101462|Primary|Cluster of Differentiation 4 (CD4+) T Cells That Proliferate and Produce Interferon (IFN)-Gamma After Antigen Activation|Mean absolute numbers of CD4(+), Carboxyfluorescein succinimidyl ester [CFSE(low)] IFN-gamma(+), and T cells after activation with a specific antigen measured by flow cytometry|Day 0, Day 7, and Day 45|"For IIV group, 18 subjects completed Visit 02 and 18 subjects completed Visit 03.~For LAIV group, 18 subjects completed Visit 02 and 18 subjects completed Visit 03."|||T Cells||Standard Error|Mean
2538325|NCT03101462|Primary|T-cell Responses|Number of Interferon gamma ELISPOT spot forming cells (SFC) per million Peripheral Blood Mononuclear Cells (PBMCs) were calculated.|Day 0, Day 7, and Day 45|"For IIV group, 18 subjects completed Visit 02 and 18 subjects completed Visit 03.~For LAIV group, 18 subjects completed Visit 02 and 18 subjects completed Visit 03."|||Cells/Million PBMC||Standard Error|Mean
2538326|NCT03101462|Primary|Serum Antibody Responses|Geometric mean hemagglutination inhibition titers to three different influenza viruses|Day 0, Day 7, and Day 45|"For IIV group, 18 subjects completed Visit 02 and 18 subjects completed Visit 03.~For LAIV group, 18 subjects completed Visit 02 and 18 subjects completed Visit 03"|||Titers||95% Confidence Interval|Geometric Mean
2538328|NCT03101371|Secondary|Number of Participants That Were Readmitted, Had Additional Clinic Visits or Went to the Emergency Department (ED) for Any Reason|Participants were monitored up to two weeks. This is the number of participants who had at least one readmission or emergency room visit during the time of observation.|Day 14 (+/- 2 days)||||Participants|||Count of Participants
2538329|NCT03101371|Secondary|Number of Participants With Closed Drainage System Disrupted During Placement of Catheter|Participants were monitored post surgery until time of discharge. This is the number of participants who had the closed drainage system disrupted during placement of catheter for back fill of the bladder during surgery.|Day 1 post op||||Participants|||Count of Participants
2538330|NCT03101371|Secondary|Number of Participants With Extended Hospital Stay Due to a Urinary Tract Infection (UTI)|Participants were monitored for up to 14 days. This is the number of participants who had a UTI in the hospital, extending their stay for more than seven days.|14 days (+/- 2 days) from surgery||||Participants|||Count of Participants
2538331|NCT03101371|Secondary|Average Patient Satisfaction|Participants were monitored at 2 weeks. This was assessed using a Likert scale questionnaire (1 = not at all satisfied, 10 = extremely satisfied). Average patient satisfaction with the catheter was assessed.|Day14 (+/- 2 days)||||score on a scale||Standard Deviation|Mean
2538332|NCT03101371|Secondary|"Number of Participants Who Received the Fill and Pull Versus the Pull and Void Method of Catheter Discontinuation"|Participants were monitored for up to 2 weeks. This is the number of participants who received one method versus the other for catheter discontinuation.|Day 14 (+/- 2 days)||||Participants|||Count of Participants
2538333|NCT03101371|Primary|Number of Participants With a Catheter Associated Urinary Tract Infection (CAUTI)|Participants were monitored for up to 14 days. This was assessed with a rapid urine analysis (UA) test. A urinary tract infection was defined as >10^5 bacterial colony forming units per ML on urine culture regardless of symptoms. This is the number of participants who had at least one CAUTI during the time of observation.|Within 14 +/- 2 days post-surgery||||Participants|||Count of Participants
2538334|NCT03101293|Secondary|Percentage of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE)||Day 1|The safety analysis set included all participants who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2538335|NCT03101293|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The PK analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration. The PK analysis population where data at specified time points were available.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2538336|NCT03101293|Primary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The PK analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2538337|NCT03101293|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-831||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The pharmacokinetic (PK) analysis set included all participants from the safety set who had at least 1 measurable postdose TAK-831 plasma concentration.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2538338|NCT03101150|Secondary|Number of Patients With Intrauterine Growth Retardation|Patients having fetus with retardation of growth in both arms.|At delivery||||Participants|||Count of Participants
2538339|NCT03101150|Secondary|Change in Vitamin D Level|Level of Improvement in Vitamin D status in both arms|At 36th week of pregnancy|"Out of 86 participants randomized for the arm of 400 IU, 3 had miscarriage and 2 lost to follow. So 81 participants were analyzed.~Out of 93 participants randomized for the arm of 4000 IU, 6 had miscarriage and 4 lost to follow. So 83 were analyzed in that arm."|||nmol/L||Standard Deviation|Mean
2538340|NCT03101150|Primary|Number of Participants With Pre-eclampsia in Both Arms|Occurrence of pre-eclampsia or not in all patients irrespective of Vitamin D dose.|From 20 weeks of pregnancy till event of pre-eclampsia seen, whichever came first, assessed up to 32 weeks.||||Participants|||Count of Participants
2538341|NCT03101033|Secondary|Functional Status Assessed by Oswestry Disability Index|ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy.|at six-month post-treatment||||units on a scale||Standard Deviation|Mean
2538342|NCT03101033|Secondary|Functional Status Assessed by Oswestry Disability Index|ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy.|at three-month post-treatment||||units on a scale||Standard Deviation|Mean
2538343|NCT03101033|Secondary|Functional Status Assessed by Oswestry Disability Index|ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy.|at one-month post-treatment||||units on a scale||Standard Deviation|Mean
2538393|NCT03100344|Secondary|Number of Participants Achieving Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24|IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used to evaluate the global severity of AD. Higher scores indicate worse outcome.|From Week 1 to Week 24|ITT population: All randomized participants.|||Participants|||Count of Participants
2538344|NCT03101033|Secondary|Functional Status Assessed by Oswestry Disability Index|ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy.|before treatment||||units on a scale||Standard Deviation|Mean
2538345|NCT03101033|Primary|Pain Assessed by Visual Analogue Scale|VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain.|at six-month post-treatment||||units on a scale||Standard Deviation|Mean
2538346|NCT03101033|Primary|Pain Assessed by Visual Analogue Scale|VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain.|at three-month post-treatment||||units on a scale||Standard Deviation|Mean
2538347|NCT03101033|Primary|Pain Assessed by Visual Analogue Scale|VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain.|at one-month post-treatment||||units on a scale||Standard Deviation|Mean
2538348|NCT03101033|Primary|Pain Assessed by Visual Analogue Scale|VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain.|before treatment||||units on a scale||Standard Deviation|Mean
2538349|NCT03101020|Secondary|Functional Activity After 6 Weeks of Intervention|"he Patient-Specific Functional Scale (PSFS) is a self-reported, patient-specific outcome measure, designed to assess functional change, primarily in patients presenting with musculoskeletal disorders Patients are asked to identify up to five important activities they are unable to perform or are having difficulty with as a result of their problem i.e. putting socks on. In addition to identifying the activities, patients are asked to rate, on an 11-point scale, the current level of difficulty associated with each activity. Following the intervention, patients are asked again to rate the activities previously identified and are given the chance to nominate new problematic activities that might have arisen during that time.0 represents unable to perform. 10 represents able to perform at prior level.~Patients select a value that best describes their current level of ability on each activity assessed. Lower scores mean a worse outcome, higher scores mean a better outcome."|6 weeks|20 participants with chronic low back pain and visceral dysfunction|||units on a scale||Standard Deviation|Mean
2538350|NCT03101020|Secondary|Disability Due to Low Back Pain After 6 Weeks of Intervention|"The Roland Morris Disability Questionnaire consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/activity, sleep/rest, psychosocial, household management, eating and pain frequency. It is designed to take approximately 5 minutes to complete, without any assistance from the administrator.~The respondent is presented with each statement and asked if they feel the statement is descriptive of their own circumstance on that day. For example, the first statement is 'I stay at home most of the day because of the pain in my back'. If the respondent feels that this statement applies to them they 'tick' the statement, otherwise they leave it blank. To score the responses, a practitioner need only add up the number of items ticked. There is no weighting applied to the statements, therefore the score can range from 0 (no disability) to 24 (maximal disability)."|6 weeks|20 participants with chronic low back pain and visceral dysfunction|||points||Standard Deviation|Mean
2538351|NCT03101020|Secondary|Low Back Mobility Using the Schober Test After 6 Weeks of Intervention|The Schober test consists of extending a tape measure on the spinal column, between the two posterior superior iliac spines and up to 10 cm above this, with the individual in a neutral position. Then, the patient is asked to do anterior flexion of the trunk, then the therapist will measure the distance of the marked points, in patients without changes of mobility should increase at least 5 cm. Increases smaller than 5 cm indicate that the test is positive, decreased mobility of the lumbar spine.|6 weeks|20 participants with chronic low back pain and visceral dysfunction|||centimeters||Standard Deviation|Mean
2538352|NCT03101020|Primary|Low Back Pain After 6 Weeks of Intervention|"An 11-point Numeric Pain Rating Scale (NPRS) will be used, where 0 is equivalent to no pain and 10 to unbearable pain"|6 weeks|20 participants with low back pain and visceral dysfunction|||units on a scale||Standard Deviation|Mean
2538353|NCT03100968|Secondary|Number of Topoffs Required||Baseline up to 1 hour||||number of topoffs required||Standard Deviation|Mean
2538354|NCT03100968|Secondary|Epidural Failure Rate|Comparing the number of epidural failures in the palpation vs. ultrasound group.|Baseline up to 1 hour||||failed epidurals|||Number
2538355|NCT03100968|Secondary|Time to Identify Midline|Comparing the time it takes to locate midline of the back in the palpation group vs. the ultrasound group. Measured in minutes from the start of the identification process until completion of the midline identification process.|Baseline up to 1 hour||||seconds||Standard Deviation|Mean
2538356|NCT03100968|Primary|Total Time||Baseline up to 1 hour||||Minutes||Standard Deviation|Mean
2538357|NCT03100968|Primary|Number of Needle Passes||Baseline up to 1 hour||||needle passes||Standard Deviation|Mean
2538358|NCT03100968|Primary|Time for Epidural Placement|Comparing the time it takes for epidural placement in the palpation group vs. the ultrasound group. Measured in minutes from local anesthesia skin wheal to administration of the epidural test dose.|Baseline up to 1 hour||||minutes||Standard Deviation|Mean
2538359|NCT03100942|Secondary|Change From Baseline in ESSPRI at Week 24|The ESSPRI is a patient-reported questionnaire to assess subjective patient symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10.|Baseline; Week 24|Participants in the Full Analysis Set were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2538415|NCT03100058|Secondary|Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion|Evaluation of 24-hour urinary phosphorus excretion after 48 weeks of treatment|Week 24, Week 48|Full Analysis Set|||mmol/24hr||Standard Deviation|Mean
2538360|NCT03100942|Secondary|Change From Baseline in ESSDAI at Week 24|The ESSDAI is a physician-administered tool designed to measure disease activity. It consists of 12 organ-specific 'domains' contributing to disease activity associated with the patient's Sjogren's Syndrome only (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. An overall score is then calculated as the sum of all individual weighted domain scores. Overall score (ranges from 0 (best) to 123 (worst activity)) is calculated as sum of all individual weighted domain scores.|Baseline; Week 24|Participants in the Full Analysis Set were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2538361|NCT03100942|Secondary|Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12|The ESSPRI is a patient-reported questionnaire to assess subjective patient symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10.|Baseline; Week 12|Participants in the Full Analysis Set were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2538362|NCT03100942|Secondary|Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12|The ESSDAI is a physician-administered tool designed to measure disease activity. It consists of 12 organ-specific 'domains' contributing to disease activity associated with the patient's Sjogren's Syndrome only (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score (ranges from 0 (best) to 123 (worst activity)) is calculated as sum of all individual weighted domain scores.|Baseline; Week 12|Participants in the Full Analysis Set were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2538363|NCT03100942|Primary|Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline|"Response was defined as:~Improvement ≥ 20% in ≥ 3 of 5 participant-reported Sjogren's syndrome (SjS) related visual analogue score (VAS) measures (participant's assessment of global disease, pain, oral dryness, ocular dryness and fatigue), with no increase defined as > 30 mm from baseline (Day 1) in any of the above 5 VAS measures, AND either ≥ 20% improvement in high sensitivity C-reactive protein (hsCRP) (if hsCRP ≥ 1.5 x ULN on Day 1) or no increase in hsCRP to ≥ 1.5 x ULN (if hsCRP < 1.5 x ULN on Day 1).~Missing data were imputed using multiple imputations with logistic regression."|Week 12|The Full Analysis Set included all randomized participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2538364|NCT03100838|Secondary|Adverse Events|Reported from the start of the first session to the follow-up visit.|66 days||||Events|||Number
2538365|NCT03100838|Primary|Half-life|The apparent terminal exponential half-life. Measurement of plasma nifedipine prior to dosing and at times 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 20, 24, 36 and 48 hr after nifedipine administration.|48 hours||||hr||Standard Deviation|Mean
2538366|NCT03100838|Primary|Area Under the Concentration (AUC 0-t)|Time curve from time zero to last measurable concentration. Measurement of plasma nifedipine prior to dosing and at times 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 20, 24, 36 and 48 hr after nifedipine administration.|48 hours||||ng.h/mL||Standard Deviation|Mean
2538367|NCT03100838|Primary|Time at Maximum Plasma Concentration (Tmax)|Measurement of plasma nifedipine prior to dosing and at times 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 20, 24, 36 and 48 hr after nifedipine administration.|48 hours||||hr||Full Range|Mean
2538368|NCT03100838|Primary|Maximum Plasma Concentration (Cmax)|Measurement of plasma nifedipine prior to dosing and at times 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 20, 24, 36 and 48 hr after nifedipine administration.|48 hours||||ng/mL||Standard Deviation|Mean
2538369|NCT03100825|Secondary|Change From Baseline in Daily Number of Puffs of Rescue Medication Over 52 Weeks|Daily use of rescue medication (number of puffs taken in the previous 12 hours) were recorded each morning and evening throughout the 52 week treatment by the participant using their electronic diary.|Baseline up to week 52|FAS included all participants who entered in the treatment epoch of this study and received at least one dose of study medication during the study. Here 'N' (overall number of participants analyzed) signified number of participants evaluable for the outcome measure.|||Number of puffs||Standard Deviation|Mean
2538370|NCT03100825|Secondary|Proportion of Participants Who Achieved Clinically Meaningful Improvement Threshold in ACQ-7 Score (Decrease of Greater Than or Equal to 0.5 Units in ACQ-7) at Week 26 and 52|ACQ-7 is a 7-item, disease-specific instrument developed and validated to assess asthma control in participants. All 7 items were scored on a 7-point likert scale, with 0 indicating total control of asthma and 6 indicating poor control of asthma. Questions were equally weighted and total score is mean of 7 items. A decrease from baseline of at least 0.5 units in ACQ-7 score was considered to be clinically meaningful improvement. The proportion of participants achieving the clinically meaningful improvement threshold in ACQ-7 score were reported at Week 26 and Week 52.|Week 26, Week 52|Analysis population included FAS with ACQ-7 data at the respective visit. Here 'n' (number analyzed) signified number of participants evaluable for specified time points.|||Percentage of participants|||Number
2538371|NCT03100825|Secondary|Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) Total Score at Week 26 and 52|ACQ-7 is a 7-item, disease-specific instrument developed and validated to assess asthma control in participants. All 7 items were scored on a 7-point Likert scale, with 0 indicating total control of asthma and 6 indicating poor control of asthma. The questions were equally weighted and the total score is the mean of the 7 items. A decrease of ACQ-7 score of at least 0.5 from baseline was considered to be clinically meaningful improvement.|Baseline, Week 26, Week 52|FAS included all participants who entered in the treatment epoch of this study and received at least one dose of study medication during the study. Here, 'n' (number analyzed) signified number of participants evaluable for the specified time points.|||Score on a scale||Standard Deviation|Mean
2538416|NCT03100058|Secondary|Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion|Evaluation of 24-hour urinary phosphorus excretion after 24 weeks of treatment|Week 24, Week 48|Full Analysis Set|||mmol/24hr||Standard Deviation|Mean
2538372|NCT03100825|Secondary|Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) Over 52 Weeks|PEF is the peak expiratory flow, the maximum speed of expiration. Electronic peak flow meter (ePEF) was given to each participant at visit 1 for the measurement of morning and evening PEF. Change from baseline in morning and evening PEF over 52 weeks was measured.|Baseline up to week 52|FAS included all participants who entered in the treatment epoch of this study and received at least one dose of study medication during the study. Here, 'n' (number anlayzed) signified number of participants evaluable for the specified time points.|||liters per minute (L/min)||Standard Deviation|Mean
2538373|NCT03100825|Secondary|Change From Baseline (Pre-dose) Forced Vital Capacity (FVC) at Week 26 and 52|Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry. Change from baseline in FVC at week 26 and 52 was reported.|Baseline (Pre-dose), Week 26, Week 52|FAS included all participants who entered in the treatment epoch of this study and received at least one dose of study medication during the study. Here, 'n' (number analyzed) signified number of participants evaluable for specified time points.|||L||Standard Deviation|Mean
2538374|NCT03100825|Secondary|Change From Baseline (Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 26 and 52|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. Change from baseline in FEV1 at week 26 and 52 was reported.|Baseline (Pre-dose), Week 26, Week 52|Full Analysis Set (FAS) included all participants who entered in the treatment epoch of this study and received at least one dose of study medication during the study. Here, 'n' (number analyzed) signified number of participants evaluable for specified time points.|||Liters (L)||Standard Deviation|Mean
2538375|NCT03100825|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)|An adverse event (AE) was any untoward medical occurrence (example; any unfavorable and unintended sign including abnormal laboratory findings, symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study until the end of study visit. TEAEs were defined as adverse events started on or after the time of the first inhalation of study drug but no later than 7 days after the last administration (30 days in the case of SAEs). SAE was defined as any adverse event (appearance of [or worsening of any pre-existing]) undesirable sign, symptom or medical conditions which is fatal or life-threatening or results in persistent or significant disability/incapacity or constitutes a congenital anomaly/birth defect or requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.|Up to 52 Weeks|Safety set included all participants who received at least one dose of study medication during the study.|||Participants|||Count of Participants
2538376|NCT03100617|Primary|Caregiver Burden|Zarit Burden scale|Change from baseline Zarit burden scale score to 3 months.|This was a feasibility study. Outcome data not collected.||||||
2538377|NCT03100500|Secondary|Change From Baseline of Rescue Medication Use During 52 Weeks Treatment|Based on the electronic-diary data, the total number of puffs of rescue medication per day over the 52 weeks were calculated and divided by the total number of days to derive the mean daily number of puffs of rescue medication taken for the participant.|Baseline up to Week 52|FAS consisted of all participants who entered the treatment epoch of this study and received at least one dose of study medication during this study. Participants with a value at both baseline and the respective post baseline month are included.|||puffs/day||Standard Deviation|Mean
2538378|NCT03100500|Secondary|Responder Rate of Participants Achieving the Minimal Important Difference (MID) of ACQ-7 ≥ 0.5 After 26 And 52 Weeks Treatment|The ACQ-7 is a seven-item disease-specific instrument developed and validated to assess asthma control in participants. It consists of five items to assess symptoms and activity limitations, one question to assess rescue medication use, and one question to assess airway caliber (FEV1% predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question (question 7) was completed by the study investigator using data from the Master Scope spirometer. The proportion of participants who achieved an improvement of at least 0.5 in ACQ-7 (i.e. decrease of ACQ-7 score of at least 0.5 from baseline) at post-baseline visits were analyzed.|Weeks 26 and 52|FAS consisted of all participants who entered the treatment epoch of this study and received at least one dose of study medication during this study. Number analyzed indicates the number of participants with data available for analysis at Weeks 26 and 52.|||percentage of participants|||Number
2538379|NCT03100500|Secondary|Change From Baseline of Asthma Control Questionnaire (ACQ-7) After 26 And 52 Weeks Treatment|The ACQ-7 is a seven-item disease-specific instrument developed and validated to assess asthma control in participants. It consists of five items to assess symptoms and activity limitations, one question to assess rescue medication use, and one question to assess airway caliber (FEV1% predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question (question 7) was completed by the study investigator using data from the Master Scope spirometer. A negative change from baseline indicates improvement in lung function.|Baseline, Weeks 26 and 52|FAS consisted of all participants who entered the treatment epoch of this study and received at least one dose of study medication during this study. Participants with a value at both baseline and the respective day are included.|||score on a scale||Standard Deviation|Mean
2538380|NCT03100500|Secondary|Change From Baseline of Morning and Evening Peak Expiratory Flow (PEF) During 52 Weeks Treatment|PEF is the greatest airflow rate achieved during forced exhalation with lungs fully inflated. PEF was analyzed separately in the morning and evening using an electronic Peak Flow Meter (ePEF). A positive change from baseline in PEF indicates improvement in lung function.|Baseline up to Week 52|FAS consisted of all participants who entered the treatment epoch of this study and received at least one dose of study medication during this study. Participants with a value at both baseline and the respective post baseline month are included.|||liters/minute (L/min)||Standard Deviation|Mean
2538409|NCT03100058|Secondary|Pharmacokinetics of LIK066: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' (AUC0-t)|Area under the plasma concentration-time curve from time zero time 't' where t is a defined time point after administration (AUC0-t)|Summary at Week 24 from qd or bid regimens (0-6h)|Full Analysis Population|||hr*ng/mL||Standard Deviation|Mean
2538381|NCT03100500|Secondary|Change From Baseline of Pre-Dose Forced Expiratory Volume in 1 Second (FEV1) Measured After 26 And 52 Weeks Treatment|The pre-dose FEV1 was defined as the mean of the pre-dose 45 and 15 min FEV1 values prior to evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. A positive change from baseline in FEV1 indicates improvement in lung function.|Baseline, Weeks 26 and 52|Full Analysis Set (FAS) consisted of all participants who entered the treatment epoch of this study and received at least one dose of study medication during this study. Participants with a value at both baseline and the respective day are included.|||liters (L)||Standard Deviation|Mean
2538382|NCT03100500|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|A TEAE is any adverse event that started on or after the time of the first inhalation of study drug but not later than 7 days (30 days in the case of a SAE) after the last administration. A SAE is described as any adverse event that leads to death, is life-threatening, results in persistent or significant disability/incapacity, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event which is medically significant.|Up to 52 weeks|Safety Set consisted of all participants who received at least one dose of study medication during this study.|||Participants|||Count of Participants
2538383|NCT03100344|Secondary|Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24|Pruritus NRS is a scale to be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For average itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.|Baseline to Week 24|ITT population: All randomized participants. Number of participants in this analysis|||Percentage of change||Standard Deviation|Mean
2538384|NCT03100344|Secondary|Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24|Pruritus NRS is a scale to be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For average itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.|Baseline to Week 24|ITT population: All randomized participants. Number of participants in this analysis|||units on a scale||Standard Deviation|Mean
2538385|NCT03100344|Secondary|Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24|Pruritus NRS is a scale to be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.|Baseline to Week 24|ITT population: All randomized participants. Number of participants in this analysis|||units on a scale||Standard Deviation|Mean
2538386|NCT03100344|Secondary|Number of Participants With Adverse Events|To evaluate the safety of nemolizumab in participants with moderate-to-severe AD|From screening to Follow-up visit (Week 32)/Early termination visit|Safety population: The safety population comprised all subjects in ITT population who received at least one dose of study drug.|||Participants|||Count of Participants
2538387|NCT03100344|Secondary|Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24|Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.|At baseline and Week 24|ITT population: All randomized participants.|||percentage of change||Standard Deviation|Mean
2538388|NCT03100344|Secondary|Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24|EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.|From Baseline to Week 24|ITT population: All randomized participants.|||Percentage of change||Standard Deviation|Mean
2538389|NCT03100344|Secondary|Number of Participants Achieving Investigator Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) and a Reduction of ≥2 Points at Each Visit up to Week 24|IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used to evaluate the global severity of AD. Higher scores indicate worse outcome.|Week 1 to Week 24|All participants in ITT population who received at least one dose of study drug.|||Participants|||Count of Participants
2538390|NCT03100344|Secondary|Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24|EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.|From Week 1 to Week 24|ITT Population: All randomized participants.|||Participants|||Count of Participants
2538391|NCT03100344|Secondary|Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24|EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.|From Week 1 to Week 24|ITT Population: All randomized participants.|||Participants|||Count of Participants
2538392|NCT03100344|Secondary|Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24|EASI is a composite score ranging from 0 to 72. The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.|From Week 1 to Week 24|ITT Population:All randomized participants.|||Participants|||Count of Participants
2538410|NCT03100058|Secondary|Pharmacokinetics of LIK066: Time to Reach the Maximum Concentration (Tmax)|Time to reach the maximum concentration after administration of LIK066 (Tmax)|Summary at Week 24 for qd or bid regimens|Full Analysis Set|||hour||Full Range|Median
2538394|NCT03100344|Secondary|Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24|The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night?: On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicate worse outcome.|Baseline, Week 24|ITT population: All randomized participants.|||units on a scale||Standard Deviation|Mean
2538395|NCT03100344|Secondary|Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24|The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night?: On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicate worse outcome.|Baseline, Week 24|ITT population: All randomized participants.|||Percentage change||Standard Deviation|Mean
2538396|NCT03100344|Secondary|Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24|SCORAD ranges from 0 to 103 and has three components: extent (body surface area [BSA]), signs, and symptoms of AD. The severity of the 6 signs of AD (erythema/darkening, edema/papulation, oozing/crusting, excoriation, lichenification/prurigo and dryness), was assessed, each on a scale ranging from 0 (none) to 3 (severe).The component of extent corresponded to the extent of BSA affected by atopic dermatitis.The BSA involvement of AD was assessed for each part of the body (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]), and was reported as a percentage of all major body sections combined. Participants were also asked to evaluate their symptoms of pruritus and sleep loss (average for the last 3 days/nights), each evaluated on a Visual analog scale (VAS) from 0 to 10. Higher scores indicate worse outcome.|Baseline, Week 24|ITT population: All randomized participants.|||units on a scale||Standard Deviation|Mean
2538397|NCT03100344|Secondary|Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24|SCORAD ranges from 0 to 103 and has three components: extent (body surface area [BSA]), signs, and symptoms of AD. The severity of the 6 signs of AD (erythema/darkening, edema/papulation, oozing/crusting, excoriation, lichenification/prurigo and dryness), was assessed, each on a scale ranging from 0 (none) to 3 (severe).The component of extent corresponded to the extent of BSA affected by atopic dermatitis.The BSA involvement of AD was assessed for each part of the body (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]), and was reported as a percentage of all major body sections combined. Participants were also asked to evaluate their symptoms of pruritus and sleep loss (average for the last 3 days/nights), each evaluated on a Visual analog scale (VAS) from 0 to 10. Higher scores indicate worse outcome.|Baseline, Week 24|ITT population: All randomized participants.|||Percentage change||Standard Deviation|Mean
2538398|NCT03100344|Secondary|Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24|Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.|From Week 1 to Week 24|ITT population: All randomized participants.|||Participants|||Count of Participants
2538399|NCT03100344|Secondary|Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24|The 4-point pruritus categorical scale was provided in their local language for the participants to report the intensity of their pruritus. Overall itching was scored as 0 for absence of pruritus and 3 for severe pruritus (bothersome itching/scratching that disturbs sleep). Higher scores indicate worse outcome.|Week 24|ITT population: All randomized participants.|||Participants|||Count of Participants
2538400|NCT03100344|Primary|Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24|EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.|From Baseline to Week 24|All participants in intent-to-treat (ITT) population who received at least one dose of study drug.|||percentage change||Standard Deviation|Mean
2538401|NCT03100123|Secondary|Study Drug Compliance|Level of compliance with study drug through patient recall and patient medication diary.|52 weeks|No participants in standard of care arm|||Participants|||Count of Participants
2538402|NCT03100123|Secondary|Crossover Rate|Crossover rate between standard of care and experimental study arms.|52 weeks||||Participants|||Count of Participants
2538403|NCT03100123|Secondary|Withdrawals/Loss to Follow-up|Proportion of withdrawals/loss to follow-up among randomized patients.|24 months||||Participants|||Count of Participants
2538404|NCT03100123|Secondary|Consent|Proportion of eligible subjects who provide consent.|24 months||||Participants|||Count of Participants
2538405|NCT03100123|Secondary|Eligibility|Proportion of screened patients who meet eligibility criteria (i.e. patients who meet inclusion criteria and are also eligible based on exclusion criteria).|24 months||||Participants|||Count of Participants
2538406|NCT03100123|Secondary|Essential Documents|Proportion of sites requiring >18 months to obtain all required approvals/contracts from time of delivery of all study documents.|18 months|Site #1 was able to obtain all applicable approvals and begin recruitment in 12 months. Not applicable applicable for site #2 as study was closed early due to low recruitment.|||Sites|||Number
2538407|NCT03100123|Primary|Study Feasibility: Mean Recruitment Rate Per Center Per Month|The primary feasibility outcome of the pilot trial is the mean recruitment rate per center per month.|24 months|1 participant was recruited (ASA alone arm) and the pilot trial was stopped early due to feasibility.|||participants|||Number
2538408|NCT03100058|Secondary|Pharmacokinetics of LIK066: Last Non-zero Concentration Area Under the Curve (AUClast)|Last non-zero concentration area under the curve (AUClast)|Summary at Week 24 from qd or bid regimens|Full Analysis Set|||hr*ng/mL||Standard Deviation|Mean
2538419|NCT03100058|Secondary|Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4)|Between -treatment analysis of percentage change from Week 24 in body weight (kg) at Week 48 (Epoch 4)|Between Week 24 and Week 48 (Epoch 4)|Full Analysis Set|||Percentage||95% Confidence Interval|Mean
2538420|NCT03100058|Secondary|Change From Baseline in 24-hour Urinary Glucose Excretion|Urinary glucose excretion will be measured from 24-hour urinary collection at indicated visits and will be analyzed at a central laboratory.|Baseline, week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)|Full Analysis Set|||mmol/24hr||95% Confidence Interval|Mean
2538421|NCT03100058|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)|At each study visit (baseline, week 24, Week 48), after the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, SBP and DBP will be measured|Baseline, Week 24 (Epoch 3) Week 24 to Week 48 (Epoch 4)|Full Analysis Set|||mmHg||95% Confidence Interval|Mean
2538422|NCT03100058|Secondary|Change From Baseline in Glycated Hemoglobin A1c (HbA1c) in Type 2 Diabetes Mellitus Patients (T2DM)|HbA1c will be measured from a blood sample obtained at indicated visits and will be analyzed at a central laboratory.|Baseline, Week 24 (Epoch 3), Week 24 to week 48 (Epoch 4)|Full Analysis Set|||mmol/L||95% Confidence Interval|Mean
2538423|NCT03100058|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) in Type 2 Diabetes Mellitus Patients (T2DM)|FPG will be measured from a blood sample obtained after an overnight fast (at least 8h after last evening food intake).|Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)|Full Analysis Set|||mmol/L||95% Confidence Interval|Mean
2538424|NCT03100058|Secondary|Percentage Change From Baseline on Waist Circumference|Waist circumference will be measured to the nearest 0.1cm in a standing position, at the end of a normal expiration, using a tape at the level of the iliac crest.|Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)|Full Analysis Set|||Percentage Change||95% Confidence Interval|Mean
2538425|NCT03100058|Secondary|Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups|Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline for dysglycemic, normoglycemic, Type 2 Diabetes Mellitus (T2DM)|Baseline, Week 24|Full Analysis Set|||Percentage|||Number
2538426|NCT03100058|Secondary|Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study|Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline|Baseline, Week 24|Full Analysis Set|||Percentage|||Number
2538427|NCT03100058|Primary|Percent Change From Baseline in Body Weight at 24 Weeks|Dose-response relationship of two dose regimens of LIK066 as measured by the percent change from baseline in body weight relative to placebo after 24 weeks of treatment|Baseline, Week 24 (Epoch 3)|Full Analysis Set|||Percent change||95% Confidence Interval|Mean
2538428|NCT03099694|Secondary|Number of Participants With Thick Secretions Causing an Airway Obstruction|determined by the clinician|during non-invasive ventilation, up to 15 days||||Participants|||Count of Participants
2538429|NCT03099694|Secondary|Length of O2 Therapy|Days|during hospitalization, up to 60 days||||days||Inter-Quartile Range|Median
2538430|NCT03099694|Secondary|Predischarge Mortality||during hospitalization, up to 60 days||||Participants|||Count of Participants
2538431|NCT03099694|Secondary|Length of Hospitalization|Days|during hospitalization, up to 60 days||||days||Inter-Quartile Range|Median
2538432|NCT03099694|Secondary|The Time of Non-invasive Ventilation|Hours|during non-invasive ventilation, up to 30 days||||hours||Inter-Quartile Range|Median
2538433|NCT03099694|Secondary|the Incidence of Abdominal Distention|Abdominal circumference increase 2 centimeter during non-invasive ventilation|during non-invasive ventilation, up to 7 days||||Participants|||Count of Participants
2538434|NCT03099694|Secondary|the Incidence of Bronchopulmonary Dysplasia(BPD)|"BPD was defined according to the National Institutes of Health consensus definition: Need for O2 supplementation(FiO2＞0.21) for at least 28 days after birth.~BPD is worse outcome."|at a post-menstrual age of 36 weeks or at discharge||||Participants|||Count of Participants
2538435|NCT03099694|Secondary|The Score of Bayley Scales of Infant Development|scores of Bayley Scales of Infant Development at 2 months old and 2 years old|30 months||2020-09-30|09/2020||||
2538436|NCT03099694|Secondary|the Incidence of Retinopathy of Prematurity (>Stage II)|The criteria for Retinopathy of prematurity (>Stage II); extraretinal fibrovascular proliferation neovascularization extends from ridge into the vitreous. Retinopathy of prematurity (>Stage II) is worse outcome.|at a post-menstrual age of 36 weeks or at discharge||||Participants|||Count of Participants
2538437|NCT03099694|Secondary|the Incidence of Neonatal Necrotizing Enterocolitis(>Stage II)|"The criteria for neonatal necrotizing enterocolitis(>stage II): Unequivocal malfunction of the gastrointestinal tract is demonstrated clinically and by radiographic evaluation. Other disorders such as malrotation and volvulus and Hirschsprung's disease must be excluded.~Neonatal necrotizing enterocolitis(>stage II) is worse outcome"|during non-invasive ventilation, up to 7 days||||Participants|||Count of Participants
2538438|NCT03099694|Secondary|the Incidence of Pneumothorax|the incidence of pneumothorax|during non-invasive ventilation, up to 7 days||||Participants|||Count of Participants
2538439|NCT03099694|Secondary|the Incidence of Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ)|The criteria for intraventricular hemorrhage (IVH, ≥ grade Ⅲ): intraventricular hemorrhage with ventricular dilatation and intraventricular hemorrhage with paren- ehymal hemorrhage. Intraventricular hemorrhage (≥ grade Ⅲ) is worse outcome.|first two months after birth||||Participants|||Count of Participants
2538440|NCT03099694|Primary|Number of Participants Who Required Intubation|The criteria for endotracheal mechanical ventilation were as follows: severe respiratory acidosis (PaCO2 > 60 mmHg with pH<7.20), severe apnea and bradycardia (defined as recurrent apnea with > 3 episodes per hour associated with heart rate < 100/min, a single episode of apnea that required bag and mask ventilation), hypoxia (FiO2>0.5 with PaO2＜50mmHg), severe respiratory distress, neonatal pulmonary hemorrhage, and cardiopulmonary arrest without effective resuscitation needing continued ventilation and rescue|during the first 7 days after birth||||Participants|||Count of Participants
2538718|NCT03093350|Secondary|Median Overall Survival|To evaluate the overall survival of patients after multiTAA-specific T cell infusion|1 year|12 patients were enrolled, but 10 were assigned to, and began, treatment. 1 patient signed consent but never began treatment, and 1 patient died before treatment began.|||days||95% Confidence Interval|Median
2538441|NCT03099655|Secondary|Post Implant Lead Failure Rate|Number of subjects with a given complication from implant through 6 months (183 days) by total number of subjects undergo Attain Stability implant procedure|Implant to 6 months|Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.|||Percent of Subjects||95% Confidence Interval|Number
2538442|NCT03099655|Secondary|LV Impedance at 6 Months|Summary statistics including mean and standard deviation will be obtained for Pacing Impedance (Ohm) measured at 6-month post implant visit for each successful implanted subject|Implant to 6 months|Subjects with a successfully implanted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.|||Ohms||Standard Deviation|Mean
2538443|NCT03099655|Secondary|LV Pacing Capture Threshold (PCT) at 6 Months|Summary statistics including mean and standard deviation will be obtained for PCT (volt) measured at 6-month post implant visit for each successful implanted subject with valid pacing data collected at 6 months post implant follow-up visit.|Implant to 6 months post-implant|Subjects with a successfully implanted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.|||Volts||Standard Deviation|Mean
2538444|NCT03099655|Secondary|Implant Duration|Summary statistics including mean and standard deviation will be obtained for total implant procedure time (minutes), fluoroscopy time, and cannulation time for each successful implant procedure.|During procedure|Subjects with a successfully implanted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.|||Minutes||Standard Deviation|Mean
2538445|NCT03099655|Secondary|Implant Success|Number of Attain Stability leads successfully implanted subjects divided by number of subjects undergo Attain Stability lead implant procedure|During procedure|Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.|||Percent of Subjects||95% Confidence Interval|Number
2538446|NCT03099655|Primary|Proportion (Reported as a Percent) of Subjects With at Least One Extra Vector Having PCT ≤ 4.0V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS)|"The co-primary efficacy endpoint is whether or not a second Model 4798 lead configuration has a pacing capture threshold less than or equal to 4V, excluding the pacing vector that is already counted to the primary efficacy.~-Model 4798 lead will be considered effective if the proportion of subjects with at least one additional Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 4.0 V at 0.5 ms pulse width (with absence of Phrenic Nerve Stimulation at 5.0 V) at 6 months post-implant is greater than 80%."|6 months post-implant|All subjects who are successfully implanted with a Model 4798 lead and with valid pacing data collected 6 months post-implant follow-up visit.|||Percent of Subjects||97.5% Confidence Interval|Number
2538447|NCT03099655|Primary|Proportion (Reported as a Percent) of Subjects With at Least One Vector Having PCT ≤2.5 V at 0.5 ms Pulse Width and Absence of Phrenic Nerve Stimulation (PNS)|"The Model 4798 LV lead has sixteen (16) programmable pacing vectors. The endpoint for the primary efficacy objective is whether or not there is at least one Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 2.5V.~-Model 4798 lead will be considered effective if the proportion of subjects with at least one Model 4798 LV lead pacing vector with pacing capture voltage thresholds less than or equal to 2.5V at 0.5 ms pulse width (with absence of Phrenic Nerve Stimulation at 5.0 V) at 6 months post-implant is greater than 80%."|6 months post-implant|Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.|||Percent of Subjects||97.5% Confidence Interval|Number
2538448|NCT03099655|Primary|Lead Complication-free Rate at 6 Months|"Subjects free of Model 4798 lead-related complications at 6 months post-implant~-Model 4798 lead will be considered safe if the probability of subjects free from Attain Stability Quad lead-related complications at 6-months post implant is greater than 87% (i.e. the one-sided 97.5% lower confidence bound must be greater than 87%). Complications were defined in the protocol as, An adverse event that includes the following is considered a complication: Results in death, Involves any termination of significant device function, or Requires an invasive intervention. Relationship of complication to the Attain Stability Quad lead was determined by an independent Clinical Events Committee."|Implant to 6 months post-implant|Subjects with an attempted Attain Stability Quad Lead Model implant, results come from PMA-S Clinical Report Version 3, 28MAR2019.|||Survival Probability (% of subjects)||97.5% Confidence Interval|Number
2538449|NCT03099369|Secondary|Change in the Vascular Quality of Life Questionnaire (VascuQol) Summary Score|At baseline, both groups will be asked to complete the Vascular Quality of Life Questionnaire (VascuQol), which is a quality-of-life survey with a summary score ranging from 25 to 175 (with 175 indicating the highest quality of life). After 3 months of the exercise program, both groups will be asked to complete the VascuQol survey again. The change in the summary score at 3 months will the secondary outcome.|Baseline, Month 3|None of the participants could be reached to obtain both baseline and endpoint telephone survey data. Therefore, data for this outcome measure are unavailable.||||||
2538450|NCT03099369|Secondary|Change in the Peripheral Artery Questionnaire (PAQ) Summary Score|At baseline, both groups will be asked to complete the Peripheral Artery Questionnaire (PAQ), which is a quality-of-life survey with a summary score ranging from 0 to 100 (with 100 indicating the highest quality of life). After 3 months of the exercise program, both groups will be asked to complete the PAQ again. The change in the summary score at 3 months will the secondary outcome.|Baseline, Month 3|None of the participants could be reached to obtain both baseline and endpoint telephone survey data. Therefore, data for this outcome measure are unavailable.||||||
2538451|NCT03099369|Primary|Change in the Mean Daily Walking Distance Over 7 Consecutive Days|At baseline, both groups will be instructed to wear their fitness monitors for 7 consecutive days. After 3 months of the exercise program, both groups will be instructed to wear their fitness monitors for 7 consecutive days. During each 7-day period, all patients will be instructed to walk continuously for at least one extended period of time on a daily basis. Given that this is a pilot study, the duration and frequency of these extended periods of time will be at the patients' discretion. The change in the mean daily walking distance at 3 months will be the primary outcome.|Baseline, Month 3|Data were not collected for 10 participants because of their inability to complete prescribed exercise program or to upload Fitbit data.|||steps||Standard Deviation|Mean
2539492|NCT03070730|Secondary|Change in Physical Functioning-CIS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Checklist Individual Strength (CIS).|1 week after second intervention|||||||
2538452|NCT03099187|Secondary|Number of Participants Withdrawn From Trial Treatment or Trial Discontinuations|Number of participants withdrawn from trial treatment or trial discontinuations are reported.|Baseline (Day 1) to Week 24|The safety population was defined as all participants with at least one intake of pirfenidone or placebo, i.e., at least one record in the drug-log of the double-blind period with a non-zero dose. Participants in the safety population were assigned to a treatment arm according to the actual treatment they received.|||Participants|||Number
2538453|NCT03099187|Secondary|Number of Participants With Dose Reductions and Treatment Interruptions|Number of participants with dose reduction and treatment interruptions are reported.|From administration of the first dose of study drug to Week 24|The safety population was defined as all participants with at least one intake of pirfenidone or placebo, i.e., at least one record in the drug-log of the double-blind period with a non-zero dose. Participants in the safety population were assigned to a treatment arm according to the actual treatment they received.|||Participants|||Number
2538454|NCT03099187|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline (Day 1) to Week 28|The safety population was defined as all participants with at least one intake of pirfenidone or placebo, i.e., at least one record in the drug-log of the double-blind period with a non-zero dose. Participants in the safety population were assigned to a treatment arm according to the actual treatment they received.|||Participants|||Number
2538455|NCT03099187|Secondary|Time to Death From Respiratory Diseases|Time to first documented death due to respiratory diseases from start of treatment will be reported.|Baseline (Day 1) to Week 24|The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses.|||Week||95% Confidence Interval|Median
2538456|NCT03099187|Secondary|Time to Death From Any Cause|Time to first documented death from start of treatment is reported.|Baseline (Day 1) to Week 24|The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses.|||Week||95% Confidence Interval|Median
2538457|NCT03099187|Secondary|Progression-free Survival (PFS)|PFS is defined as the time to the first occurrence of a >10% absolute decline in percent predicted FVC, non-elective respiratory hospitalization, or death.|Baseline (Day 1) to Week 24|The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses.|||Week||95% Confidence Interval|Median
2538458|NCT03099187|Secondary|Progression-free Survival (PFS)|PFS is defined as the time to the first occurrence of a >10% absolute decline in percent predicted FVC, a >50 m decline of 6MWD, or death.|Baseline (Day 1) to Week 24|The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses.|||Week||95% Confidence Interval|Median
2538459|NCT03099187|Secondary|Time to First Investigator-reported Acute Exacerbations|Time to first investigator reported acute exacerbations from start of treatment are reported.|Baseline (Day 1) to Week 24|The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses.|||Weeks||95% Confidence Interval|Median
2538460|NCT03099187|Secondary|Percentage of Participants With Investigator-reported Acute Exacerbations|Percentage of participants with acute exacerbation arereported.|Baseline (Day 1) to Week 24|The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses.|||Percentage|||Number
2538461|NCT03099187|Secondary|Number of Participants With Non-elective Hospitalization, Both Respiratory and All Cause|Participants with non-elective hospitalization are reported.|Baseline (Day 1) to Week 24|The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses.|||Participants|||Number
2538462|NCT03099187|Secondary|Change in Total and Sub-scores of the Saint George's Respiratory Questionnaire (SGRQ)|The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in participants with diseases of airways obstruction. Three component scores are: Symptoms (respiratory symptoms and severity); Activity (activities that cause or are limited by breathlessness); Impacts (social functioning and psychological disturbances due to airway disease). Each component sub-scores are calculated from the summed weights for the positive responses to questions. Total score summaries the impact of disease on overall health status. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. It is calculated by summing all positive responses in the questionnaire and expressing the result as a percentage of the total weight for the questionnaire.|Baseline (Day 1) to Week 24|The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis.|||Scores of a Scale||Standard Deviation|Mean
2538463|NCT03099187|Secondary|Change in Cough Visual Analog Scale (VAS) Score|Cough VAS are 100-mm linear scales on which participants indicate the severity of their cough; 0 mm represents no cough and 100 mm the worst cough ever.|Baseline (Day 1) to Week 24|The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis.|||millimeter (mm)||Standard Deviation|Mean
2538475|NCT03099161|Secondary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 per investigator review. The ORR per RECIST 1.1 for participants is presented.|Up to approximately 8 months|All participants who had a baseline scan that showed measurable disease by investigator assessment and who received at least one dose of study treatment|||Percentage of Participants||95% Confidence Interval|Number
2538464|NCT03099187|Secondary|Change in Score in Leicester Cough Questionnaire Score|The Leicester Cough Questionnaire is a patient-reported questionnaire evaluating the impact of cough on quality of life. The questionnaire comprises 19 items. Each item assesses symptoms, or the impact of symptoms, over the last 2 weeks on a seven-point Likert scale. Scores in three domains (physical, psychological and social) were calculated as a mean for each domain (range 1 to 7). A total score (range 3 to 21) was also calculated by adding the domain scores together. Higher scores indicate better quality of life.|Baseline (Day 1) to Week 24|The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis.|||Scores on a Scale||Standard Deviation|Mean
2538465|NCT03099187|Secondary|Change in University of California, San Diego-Shortness of Breath Questionnaire Score|University of California, San Diego Shortness of Breath Questionnaire (SOBQ) consists of 24-item on a scale of 0 to 5 with 0=not at all and 5=maximal or unable to do because of breathlessness. The total scores were calculated by summation of the 24 items scores and transformed into 0-100, with 0= poor quality of life , and 100= excellent quality of life.|Baseline (Day 1) to Week 24|The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis.|||Scores on a Scale||Standard Deviation|Mean
2538466|NCT03099187|Secondary|Change in 6-minute Walk Distance (6MWD)|Comparison of 6-minute walk distance before beginning and after completing study therapy.|Baseline (Day 1) to Week 24|The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis.|||meter (m)||Standard Deviation|Mean
2538467|NCT03099187|Secondary|Change in Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLco)|The DLco is a pulmonary function test that measures the capacity for the lung to carry out gas exchange between the inhaled breath and the pulmonary capillary blood vessels and the DLco %-predicted represents the DLco expressed as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity.|Baseline (Day 1) to Week 24|The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis.|||percentage||Standard Deviation|Mean
2538468|NCT03099187|Secondary|Categorical Change in FVC of >10%|Categorical change in FVC was measured both by daily spirometry as well as by spirometry during clinical visits. Only the site spirometry data were used as the daily spirometry data were not normally distributed.|Baseline (Day 1) to Week 24|The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses.|||participants|||Number
2538469|NCT03099187|Secondary|Categorical Change in FVC of >5%|Categorical change in FVC was measured both by daily spirometry as well as by spirometry during clinical visits. Only the site spirometry data were used as the daily spirometry data were not normally distributed.|Baseline (Day 1) to Week 24|The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses.|||participants|||Number
2538470|NCT03099187|Secondary|Change in FVC|FVC was measured in liter (L) by spirometry.|Baseline (Day 1) to Week 24|The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis.|||Litre (L)||Standard Deviation|Mean
2538471|NCT03099187|Secondary|Change in Percent Predicted FVC|FVC was measured in liter (L) by spirometry.|Baseline (Day 1) to Week 24|The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis.|||Percent predicted (%)||Standard Deviation|Mean
2538472|NCT03099187|Primary|Rate of Decline in Forced Vital Capacity (FVC) Over the 24-week Double-blind Treatment Period|Rate of decline in FVC was measured in mL by daily handheld spirometer.|Up to Week 24|The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis.|||milliliter (mL)||95% Confidence Interval|Mean
2538473|NCT03099161|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. The number of participants who discontinued study treatment due to an AE is presented.|Up to approximately 8 months|All participants who received at least one dose of study treatment|||Participants|||Count of Participants
2538474|NCT03099161|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. The number of participants who experienced at least one AE is presented.|Up tp approximately 8 months|All participants who received at least one dose of study treatment|||Participants|||Count of Participants
2538510|NCT03098641|Secondary|Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery|Pelvic organ prolapse quantification (POP-Q) Staging Criteria Prolapse is staged using POP-Q criteria that can range from good support (no organ descent) reported as a POP-Q stage 0 or I to a POP-Q score of IV (complete procidentia or vault eversion)|up to 4 years after surgery|Data was collected retrospectively and few pelvic organ prolapse stage were not available|||Participants|||Count of Participants
2538476|NCT03099161|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4. A DLT was defined as any of the following events: Grade (Gr) 4 non-hematologic toxicity (not laboratory); Gr 4 hematologic toxicity lasting ≥7 days; Gr 4 thrombocytopenia of any duration; Gr 3 thrombocytopenia with bleeding; Gr 3 non-hematologic toxicity (not laboratory) lasting >3 days despite optimal supportive care; Gr 3 or Gr 4 non-hematologic laboratory value requiring treatment, hospitalization, or persisting for >72 hours; alanine aminotransferase (ALT) or aspartate aminotransferase(AST) >3X upper limit of normal (ULN) WITH total bilirubin >2X ULN with no elevation in alkaline phosphatase (<2X ULN); Febrile neutropenia Gr 3 or 4; discontinuation during Cycle 1 or a >2 week delay in initiating Cycle 2 due to treatment-related toxicity; Missing >25% of preladenant doses as a result of adverse events during Cycle 1; or Gr 5 toxicity.|Cycle 1 (up to 21 days)|All participants who received at least one dose of study treatment in Cycle 1 (21-day Cycle) and were observed for safety or experienced a DLT during Cycle 1|||Participants|||Count of Participants
2538477|NCT03099096|Secondary|Percentage of Participants With Successful Self-administration of Their Unobserved Dose at Week 4 - Autoinjector With Standard Label Only|Due to differences in the labeling requirements among regulatory authorities around the world, two different labeling approaches were included in this global study: labeling that includes a pictogram plus standard labeling elements, or a standard labeling without the pictogram. Data for participants (and/or their caregiver) self-administering the second dose unobserved, at home (Week 4) using Autoinjector with Standard Label has been presented. Only participants with data available at Week 4 were analyzed.|Week 4|All Subjects (Safety) Population|||Percentage of participants|||Number
2538478|NCT03099096|Secondary|Percentage of Participants With Successful Self-administration of Their Unobserved Dose at Week 4 - Autoinjector With Standard Label + Pictogram|Due to differences in the labeling requirements among regulatory authorities around the world, two different labeling approaches were included in this global study: labeling that includes a pictogram plus standard labeling elements, or a standard labeling without the pictogram. Data for participants (and/or their caregiver) self-administering the second dose unobserved, at home (Week 4) using Autoinjector with Standard Label + Pictogram has been presented. Only participants with data available at Week 4 were analyzed.|Week 4|All Subjects (Safety) Population|||Percentage of participants|||Number
2538479|NCT03099096|Primary|Percentage of Participants With Successful Self-administration of Their Observed Third Dose at Week 8 - Autoinjector With Standard Label Only|Due to differences in the labeling requirements among regulatory authorities around the world, two different labeling approaches were included in this global study: labeling that includes a pictogram plus standard labeling elements, or a standard labeling without the pictogram. Participants (and/or their caregiver) attended three on treatment visits at Week 0, Week 4, Week 8, and the End of Study Visit. Training on the study treatment, device handling and administration techniques was provided by the investigator or qualified site staff at Week 0 and then first dose was self-administered under observation of investigator/site staff in clinic. Second dose self-administered unobserved, at home (Week 4) and third dose was self-administered under the observation of investigator/site staff in clinic (Week 8). Only participants with data available at Week 8 were analyzed.|Week 8|All Subjects (Safety) Population|||Percentage of Participants|||Number
2538480|NCT03099096|Primary|Percentage of Participants With Successful Self-administration of Their Observed Third Dose at Week 8 - Autoinjector With Standard Label + Pictogram|Due to differences in the labelling requirements among regulatory authorities around the world, two different labelling approaches were included in this global study: labelling that includes a pictogram plus standard labelling elements, or a standard labelling without the pictogram. Participants (and/or their caregiver) attended three on treatment visits at Week 0, 4, 8, and End of Study Visit. Training on the study treatment, device handling and administration technique was provided by the investigator or qualified site staff at Week 0 and then first dose was self-administered under observation of investigator/site staff in clinic. Second dose self-administered unobserved, at home (Week 4) and third dose was self-administered under the observation of investigator/site staff in clinic (Week 8). All Subjects (Safety) Population included all enrolled participants attempting at least one self-administration of mepolizumab. Only participants with data available at Week 8 were analyzed.|Week 8|All Subjects (Safety) Population|||Percentage of participants|||Number
2538481|NCT03098979|Secondary|Measured Values and Absolute Change in 3 Scores From Kansas City Cardiomyopathy Questionnaire (KCCQ) From Baseline to 20 Weeks: Overall Summary Score, Physical Limitation Score and Total Symptom Score|"The KCCQ is the leading health-related quality-of-life measure for patients with chronic heart failure (CHF). It is a 23-item questionnaire that independently measures the impact of patient's heart failure (HF), or its treatment, on 7 distinct domains: 1) Symptom Frequency 2) Symptom Burden 3) Physical Limitation 4) Quality of Life 5) Social Limitations 6) Self-efficacy 7) Symptoms Stability.~Overall summary score= mean score of (symptom frequency + symptom burden+ physical limitation + quality of life + social limitation); scores on a scale of 0 to 100, higher scores means better outcome; Physical Limitation: scores on a scale of 0 to 100, higher scores means better outcome; Total symptom score=mean score of (symptom frequency + symptom burden): scores on a scale of 0 to 100, higher scores means better outcome.~Positive change means improvement and negative change means deterioration."|Baseline, and up to 20 weeks of treatment|Per-protocol set (PPS): Included all full analysis set (FAS) population subjects without validity findings for this outcome measure|||scores on a scale||Standard Deviation|Mean
2538482|NCT03098979|Secondary|Measured Values (Log-transformed) and Absolute Change in High Sensitivity Troponin T (Hs-TNT) From Baseline to 20 Weeks|High sensitivity troponin T (hs-TNT) was measured|Baseline, and up to 20 weeks of treatment|Per-protocol set (PPS): Included all full analysis set (FAS) population subjects without validity findings for this outcome measure|||log(pg/mL)||Full Range|Median
2538483|NCT03098979|Secondary|Measured Values (Log Transformed) and Absolute Change in NT-proBNP From Baseline to 20 Weeks|NT-proBNP = N-terminal pro-hormone b-type natriuretic peptide|Baseline, and up to 20 weeks of treatment|Per-protocol set (PPS): Included all full analysis set (FAS) population subjects without validity findings for this outcome measure|||log (pg/ml)||Full Range|Median
2538719|NCT03093350|Secondary|Median Progression-free Survival|To evaluate the progression-free survival of patients after multiTAA-specific T cell infusion|1 year|12 patients were enrolled, but 10 were assigned to, and began, treatment. 1 patient signed consent but never began treatment, and 1 patient died before treatment began.|||days||95% Confidence Interval|Median
2538484|NCT03098979|Secondary|Change From Baseline in Average Weekly Percentage of Maximum Possible Recorded Activity Intensity|"AVIVO™ Mobile Patient Management System, a wearable wireless device worn by the subject, was used to monitor subjects' cardiovascular status. The patient's everyday physical activity e.g. duration, intensity, was also tracked by the AVIVO device. For Activity Intensity, the Unit of Measure is percentage of maximum activity, and length of intervals is daily."|Baseline, and up to 20 weeks of treatment|Per-protocol set (PPS): Included all full analysis set (FAS) population subjects without validity findings for this outcome measure|||percentage of maximum activity||Standard Deviation|Mean
2538485|NCT03098979|Primary|Absolute Change From Baseline in 6-minute Walking Distance (6MWD) After 20 Weeks of Treatment|The 6MWD test is designed to evaluate a subject's exercise capacity while performing an everyday activity.|Baseline, and up to 20 weeks of treatment|Per-protocol set (PPS): Included all full analysis set (FAS) population subjects without validity findings for this outcome measure, and it also included subjects who were censored due to cardiovascular (CV) death or hospitalization for heart failure (HF) that prevented assessment of efficacy at 20 weeks.|||meter||Standard Deviation|Mean
2538486|NCT03098966|Secondary|Adverse Perinatal Outcomes|"• Adverse perinatal outcomes:~Apgar score~Neonatal Intensive Care Unit admission~Respiratory morbidity, e.g. transient tachypnoea of the newborn~Hypoxic ischaemic encephalopathy~Birth trauma~Mortality"|48 hours postpartum||||Participants|||Count of Participants
2538487|NCT03098966|Secondary|Number of Participants Who Had Maternal Morbidity|"• Maternal morbidity:~Uterine rupture~Surgical injuries (during emergency CS)~Hemorrhage and blood transfusion~Peripartum hysterectomy"|48 hours after onset of trial of labor||||Participants|||Count of Participants
2538488|NCT03098966|Primary|Number of Participants With Successful Vaginal Birth|Mode of delivery: either successful vaginal birth after cesarean section or failed trial of labor (ending in emergency intrapartum cesarean section).|24 hours after onset of trial of labor||||Participants|||Count of Participants
2538489|NCT03098745|Primary|Bulbar Redness|Redness of bulbar conjunctiva (Scale: 0-4, 0 = none, 4=severe)|1 Hour||||units on a scale||Standard Deviation|Mean
2538490|NCT03098745|Primary|Limbal Redness|Redness of limbal area (Scale: 0-4, 0 = none, 4=severe)|1 Hour||||units on a scale||Standard Deviation|Mean
2538491|NCT03098745|Primary|Lens Fit Preference|Investigator lens fit preference (Scale: omafilcon A, somofilcon A, omafilcon A - Proclear (PC))|1 Hour||||Participants|||Count of Participants
2538492|NCT03098745|Primary|Lens Fit Acceptance|Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)|1 Hour||||Participants|||Count of Participants
2538493|NCT03098745|Primary|Lens Fit Acceptance|Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)|Insertion||||Participants|||Count of Participants
2538494|NCT03098745|Primary|Post-blink Lens Movement|Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)|1 Hour||||Participants|||Count of Participants
2538495|NCT03098745|Primary|Post-blink Lens Movement|Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)|Insertion||||Participants|||Count of Participants
2538496|NCT03098745|Primary|Lens Centration|Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)|1 Hour||||Participants|||Count of Participants
2538497|NCT03098745|Primary|Lens Centration|Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)|Insertion||||Participants|||Count of Participants
2538498|NCT03098745|Primary|Comfort|Subjective comfort (Scale 0-100: 0=very uncomfortable, 100= very comfortable)|Insertion, 1hr||||units on a scale||Standard Deviation|Mean
2538499|NCT03098745|Primary|Visual Acuity|High contrast distance visual acuity assessed for each lens pair using LogMAR chart at time of lens insertion, then assessing again 1 hour later with spectacles after lenses are removed.|Baseline (lens insertion), 1 hour||||logMAR||Standard Deviation|Mean
2538500|NCT03098641|Secondary|Postoperative Score at Numeric Pain Rating Scale|The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)|up to 48 hours after surgery||||units on a scale||Standard Deviation|Mean
2538501|NCT03098641|Secondary|Preoperative Score at Numeric Pain Rating Scale|The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)|Within 48 hours before surgery||||units on a scale||Standard Deviation|Mean
2538502|NCT03098641|Secondary|Number of Patients With Postoperative Dyspareunia|Patients reporting pain|up to 4 years after surgery||||Participants|||Count of Participants
2538503|NCT03098641|Secondary|Number of Patients With Postoperative Active Sexuality|Patients reporting active sexuality|up to 4 years after surgery||||Participants|||Count of Participants
2538504|NCT03098641|Secondary|Number of Patients With Preoperative Dyspareunia|Patients reporting pain|within 4 weeks before surgery||||Participants|||Count of Participants
2538505|NCT03098641|Secondary|Number of Patients With Preoperative Active Sexuality|Patients reporting active sexuality|within 4 weeks before surgery||||Participants|||Count of Participants
2538506|NCT03098641|Secondary|Number of Patients With Postoperative Digestive Signs|dyschezia, incontinence|up to 4 years after surgery|Data was collected retrospectively and few bowel symptom descriptions were not available|||Participants|||Count of Participants
2538507|NCT03098641|Secondary|Number of Patients With Preoperative Digestive Signs|dyschezia, incontinence|within 4 weeks before surgery|Data was collected retrospectively and few bowel symptom descriptions were not available|||Participants|||Count of Participants
2538508|NCT03098641|Secondary|Number of Patients With Postoperative Urinary Signs|urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence|up to 4 years after surgery|Data was collected retrospectively and few bladder symptom descriptions were not available|||Participants|||Count of Participants
2538509|NCT03098641|Secondary|Number of Patients With Preoperative Urinary Signs|urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence|within 4 weeks before surgery|Data was collected retrospectively and few bladder symptom descriptions were not available|||Participants|||Count of Participants
2538860|NCT03090958|Primary|Average Total Time in Minutes Participants Spent Using App.|Feasibility of AllyQuest will be based on usage as measured by the average time spent using app.|4 weeks|Missing data on 3 participants, hence only reporting data on 17 participants.|||Minutes||Standard Deviation|Mean
2538511|NCT03098641|Secondary|Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery|Pelvic organ prolapse quantification (POP-Q) Staging Criteria Prolapse is staged using POP-Q criteria that can range from good support (no organ descent) reported as a POP-Q stage 0 or I to a POP-Q score of IV (complete procidentia or vault eversion)|preoperative, within 48 hours before surgery|Data was collected retrospectively and few pelvic organ prolapse stage were not available|||Participants|||Count of Participants
2538512|NCT03098641|Secondary|Number of Patients With Late Complications|self-catheterization, recurrent urinary tract infections, de novo urinary stress incontinence, chronic pain, vaginal prosthesis exposure, prolapse recurrence, secondary surgery, other|up to 4 years after surgery||||Participants|||Count of Participants
2538513|NCT03098641|Secondary|Number of Patients With Early Complications|Urinary retention, urinary tract infection, hematoma, ureteral complication, second surgery|up to 30 days after surgery||||Participants|||Count of Participants
2538514|NCT03098641|Primary|Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding|Perioperative morbidity|up to 30 days after surgery||||Participants|||Count of Participants
2538515|NCT03098615|Secondary|Clinical or Mycological Cure of Nail|Completely normal nail plate or negative fungal culture|week 48||||Participants|||Count of Participants
2538516|NCT03098615|Primary|Number of Participants With Elimination of Dermatophytomas That Occur in Distal Lateral Subungual Onychomycosis (DLSO)|Clear nail growth between the proximal nail fold and the dermatophytoma's proximal edge will be measured.|week 48||||Participants|||Count of Participants
2538517|NCT03098173|Secondary|Number of Participants With Colonoscopy-related Adverse Events|Colonoscopy-related adverse events will include hemorrhagic shock, and perforation.|0-4 day||||Participants|||Count of Participants
2538518|NCT03098173|Secondary|Number of Participants With Preparation-related Adverse Events|Preparation-related adverse events will include nausea, vomiting, abdominal pain, volume overload, aspiration pneumonia, hemorrhagic shock, exacerbation bleeding, and ileus|0-4 day||||Participants|||Count of Participants
2538519|NCT03098173|Secondary|Number of Participants With Thirty-day Death Events|Number of Participants with Thirty-day death Events from enrollment|30 day||||Participants|||Count of Participants
2538520|NCT03098173|Secondary|Number of Participants With Thirty-day Thrombosis Events|Thrombosis events will include acute coronary syndromes, including angina pectoris and myocardial infarction, stroke, including cerebrovascular infarction, cerebral hemorrhage, and transient ischemic attacks, deep vein thrombosis, and pulmonary embolism.|30 day|Rebleeding,thrombotic events, and mortality were evaluated for patients who approximately met the 30-day follow-up criteria (early colonoscopy for 72 patients and elective colonoscopy for 75 patients).|||Participants|||Count of Participants
2538521|NCT03098173|Secondary|Length of Stay|It will be defined as length of stay to cure acute lower gastrointestinal bleeding.|0-34 day||||days||Standard Deviation|Mean
2538522|NCT03098173|Secondary|Need for Transfusion During Hospitalization|It will be defined as the numbers of patients who will need transfusion.|During hospitalization||||Participants|||Count of Participants
2538523|NCT03098173|Secondary|Thirty-day Rebleeding Rates|"Rebleeding will be defined as significant fresh blood loss after an initial colonoscopy with any of the following criteria:~i) Hemorrhagic shock, including cold sweat, nausea, syncope, or systolic blood pressure ≤ 90 mmHg.~ii) Need for transfusion, according to the guidelines of the Ministry of Health, Labour, and Welfare.~iii) Further colonoscopy identifies blood pooling, or iv) SRH in the lower gastrointestinal tract. v) Contrast-enhanced CT identifies extravasation in the colorectal region. However, these examinations will not be performed routinely if rebleeding occurs in the study period."|30 day|Rebleeding,thrombotic events, and mortality were evaluated for patients who approximately met the 30-day follow-up criteria (early colonoscopy for 72 patients and elective colonoscopy for 75 patients).|||Participants|||Count of Participants
2538524|NCT03098173|Secondary|Need for Surgery|It will be defined as surgery to achieve hemostasis.|0-34 day||||Participants|||Count of Participants
2538525|NCT03098173|Secondary|Need for Interventional Radiology|It will be defined as radiology intervention to achieve hemostasis.|0-34 day||||Participants|||Count of Participants
2538526|NCT03098173|Secondary|Need for Additional Endoscopic Examinations|Additional endoscopic examinations will be defined as examinations to achieve hemostasis.|0-34 day||||Participants|||Count of Participants
2538527|NCT03098173|Secondary|Success Rate of Endoscopic Treatment; Number of Participants Achieving Hemostasis With Endoscopic Treatment|Success rate will be defined as the number achieving hemostasis per total number of attempts at endoscopic hemostasis during colonoscopy examination.|0-4 day|Success rate of endoscopic treatment was defined as achievement of hemostasis (early for 15 patients and elective for 15 patients).|||Participants|||Count of Participants
2538528|NCT03098173|Primary|Stigmata of Recent Hemorrhage (SRH) Identification Rate|Stigmata of Recent Hemorrhage (SRH) based on colonoscopic visualization of lesions, such as diverticulosis, tumor, ulcer, hemorrhoid, angioectasia, and polyps exhibiting active bleeding, a visible vessel, or an adherent clot.|0-4 day|The primary analysis included a modified intention-to-treat population, excluding the following patients from the genuine intention-to-treat analysis set: 1) those who did not satisfy the enrollment criteria after randomization; 2) those who provided no post-randomization data on primary outcome; and 3) those who did not undergo colonoscopy|||Participants|||Count of Participants
2538529|NCT03097861|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence (including clinically significant changes in laboratory values or other clinical tests) experienced by a participant administered a pharmaceutical product regardless of causal relationship with the treatment. A TEAE is an episode which occur after the administration of the first dose of study medication and within 7 days after final dose.|From first dose of study medication to follow-up (up to 15 days)|Safety population, defined as all randomized participants who took at least one dose of double-blinded study medication.|||Participants|||Count of Participants
2538530|NCT03097861|Secondary|Mean SBM Straining Score Within 1 Week|Bowel straining associated with SBMs was rated on a scale of 0-4 where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very severe. Higher score indicates more straining, so a worse condition.|during the 1-week treatment period|PP population. Number of participants analysed indicates participants who were evaluated for this outcome measure at each time point.|||score on a scale||Standard Deviation|Mean
2538531|NCT03097861|Secondary|Mean SBM Consistency Score Within 1 Week|Stool consistency associated with SBMs was rated according to the 7-point Bristol Stool Form Scale (1-7) where 1 = Separate hard lumps, like nuts (hard to pass), 2 = Sausage-shaped but lumpy, 3 = Like a sausage but with cracks on the surface, 4 = Like a sausage or snake, smooth and soft, 5 = Soft blobs with clear-cut edges (passed easily), 6 = Fluffy pieces with ragged edges, a mushy stool, 7 = Watery, no solid pieces; entirely liquid. Scores in the mid-range of this scale indicate better stool consistency.|during the 1-week treatment period|PP population. Number of participants analysed indicates participants who were evaluated for this outcome measure at each categorical time point.|||score on a scale||Standard Deviation|Mean
2538532|NCT03097861|Primary|Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week|Observed SBM count was based on the observed data reported in the electronic daily diary for the actual number of SBMs during the 1-week treatment period.|during the 1-week treatment period|Per protocol population|||SBMs/week||Standard Deviation|Mean
2538533|NCT03097614|Primary|Eye Dryness Score|"Eye Dryness Score using a visual analog scale assessed in the Controlled Adverse Environment (CAE). The participant rates their current eye dryness (both eyes simultaneously) by scoring 0 to indicate no discomfort and 100 to indicate maximal discomfort. The assessment line length of the scale will be 100 mm."|Day 45|Of the 57 subjects that initiated the study, 48 subjects achieved the threshold and performed an application in the CAE at Day 45.|||Score on Scale||Standard Error|Mean
2538534|NCT03097484|Secondary|Length of Medication Therapy|How long the infant requires medication to treat symptoms.|Up to 4 months||||days||Standard Deviation|Mean
2538535|NCT03097484|Primary|Length of Hospitalization|How long the infant remains hospitalized.|Up to 4 months||||days||Standard Deviation|Mean
2538536|NCT03097341|Secondary|The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) in Healthy Adult Subjects Will be Measured.|Activated partial thromboplastin time (aPTT) will be used as a surrogate pharmacodynamic marker.|Pre-dose (0.5h prior to dose), 1, 24,72, 168, 336, 504, 672h after dosing as well as follow up (7 days after day 29 or after aPTT returned back to baseline)..|All subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to treatment.|||seconds||Standard Deviation|Mean
2538537|NCT03097341|Secondary|The Total Apparent Volume of Distribution (Vss) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject.|The total apparent volume of distribution (Vss) will be calculated as the mean residence time x clearance. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.|Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).|All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.|||Liters||Standard Deviation|Mean
2538538|NCT03097341|Secondary|The Apparent Total Plasma Clearance (CL) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject.|The apparent total plasma clearance will be calculated as [Dose/AUC0-inf]. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.|Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).|All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.|||Liters/hour||Standard Deviation|Mean
2538539|NCT03097341|Secondary|The Apparent First Order Terminal Elimination Half-life (T1/2) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject.|The apparent first order terminal elimination half-life will be calculated as 0.693/Kel. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.|Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).|All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.|||hours||Standard Deviation|Mean
2538540|NCT03097341|Secondary|The Apparent First Order Terminal Elimination Rate Constant (Kel) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject.|The apparent first order terminal elimination rate constant will be calculated from a semi-log plot of the plasma concentration versus time curve. The parameter will be calculated by linear least squares regression analysis using the maximum number of points in the terminal log linear phase (e.g., three or more non zero plasma concentrations). Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.|Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).|All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.|||1/hour||Standard Deviation|Mean
2538541|NCT03097341|Secondary|The Percent of AUC0-inf Extrapolated (AUC%Extrap) After a Single Injection of Xisomab 3G3 Will be Calculated for Each Subject.|The percent of AUC0-inf extrapolated (AUC%extrap) is calculated by (1-AUC0-t/AUC0-inf)*100. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.|Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).|All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.|||percentage of AUC0-inf||Standard Deviation|Mean
2538542|NCT03097341|Secondary|The Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) After a Single Injection of Xisomab 3G3 Will be Calculated for Each Subject.|The area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.|Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).|All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.|||nanogram*hour/milliliter||Standard Deviation|Mean
2538543|NCT03097341|Secondary|The Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Non-zero Concentration (AUC0-t), as Calculated by the Linear Trapezoidal Method, After a Single Injection of Xisomab 3G3 Will be Calculated for Each Subject.|The area under the plasma concentration-time curve from time 0 to the last measurable non-zero concentration was estimated based on plasma xisomab 3G3 concentrations. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.|Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).|All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.|||nanograms*hour/milliliter||Standard Deviation|Mean
2538544|NCT03097341|Secondary|The Time to Reach Maximum Plasma Concentrations of Xisomab 3G3 (Tmax) After a Single Injection Will be Measured in Each Subject.|The time to reach maximum plasma concentrations of xisomab 3G3 after a single injection was estimated based on plasma xisomab 3G3 concentrations. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.|Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).|All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.|||hours||Full Range|Median
2538545|NCT03097341|Secondary|The Maximum Plasma Concentration (Cmax) of Xisomab 3G3 After a Single Injection Will be Measured in Each Subject.|Maximum plasma concentration of xisomab 3G3 was estimated based on plasma xisomab 3G3 concentrations. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.|Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).|All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.|||nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2538546|NCT03097341|Primary|The Number of Subjects That Develop Treatment-related Immunogenicity Will be Summarized Using Frequency Counts.|Immunogenicity measured by the presence of plasma anti-drug antibodies|From Study Day 1 through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2538547|NCT03097341|Primary|The Number of Subjects With Abnormal Laboratory Values and/ or Adverse Events That Are Related to Treatment Will be Summarized Using Frequency Counts..|Clinical laboratory tests include serum chemistry, hematology, coagulation parameters (aPTT, PT, and bleeding time), and urinalysis|From subject Check-In through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2538548|NCT03097341|Primary|The Number of Subjects With Abnormal Injection Site Reaction That Are Related to Treatment Will be Summarized Using Frequency Counts..|Injection site reaction (pain, tenderness, erythema/ redness, and induration/ swelling)|From Study Day 1 through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2538549|NCT03097341|Primary|The Number of Subjects With Abnormal Electrocardiogram That is Related to Treatment Will be Summarized Using Frequency Counts..|12-lead electrocardiogram measurement|From subject Check-In through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2538550|NCT03097341|Primary|The Number of Subjects With Abnormal Vital Signs That Are Related to Treatment Will be Summarized Using Frequency Counts..|Vital sign measurements (body temperature, respiratory rate, blood pressure, and heart rate)|From subject Check-In through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2538551|NCT03097341|Primary|The Number of Subjects With Treatment-related Adverse Events (TEAEs) Will be Summarized Using Frequency Counts.|TEAEs will be determined by physical examination that will include assessment of skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, gastrointestinal system, neurological condition, blood and lymphatic systems, and the musculoskeletal system.|From Subject Check-In through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.|Subjects who received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2538552|NCT03097289|Primary|Number of Days of Platelet Survival|Survival of platelets stored in InterSol for 5 Days as compared to fresh controls. Survival was expressed in days and was approximated using linear regression. The FDA acceptance criteria for survival is >58% of control with a 1-sided 97.5% confidence limit|11 days (+/- 1 day)|"The Full Analysis Set (FAS) consisted of all completed procedures/products where the corresponding Test and Control values for primary endpoint were valid. Data points could be excluded from FAS if:~Primary endpoint laboratory samples were lost/not available~Failure of site to follow post-collection handling procedures for endpoint assays"|||days||Standard Deviation|Mean
2538553|NCT03097289|Primary|Recovered Percentage of the Extrapolated Platelet Count at Time 0|The percent recovery of platelets stored in InterSol for 5 Days as compared to fresh controls. Percent recovery was expressed as a percentage and was extrapolated for a value at Time 0. The FDA acceptance criteria for recovery is >66% of control with a 1-sided 97.5% confidence limit.|11 days (+/- 1 day)|"The Full Analysis Set (FAS) consisted of all completed procedures/products where the corresponding Test and Control values for primary endpoint were valid. Data points could be excluded from FAS if:~Primary endpoint laboratory samples were lost/not available~Failure of site to follow post-collection handling procedures for endpoint assays"|||percent of extrapolated platelet count||Standard Deviation|Mean
2538554|NCT03097029|Other Pre-specified|Change in Malabsorption Blood Test|This test will only be performed on subjects 18 years or older. This an isotope test. Subjects consume a high fat shake with two labeled fats. They have blood tests measured at baseline and then every 1 hour for 8 hours to check for serum levels of labeled fats. This helps determine how well the labeled fats are being absorbed by the intestine.|Up to 10 days|||||||
2538555|NCT03097029|Secondary|Change in the Coefficient of Nitrogen Absorption|Coefficient of nitrogen absorption (CNA) measures the amount of nitrogen excreted in the stool compared to how much nitrogen was consumed in a 72 hour period. This is a measure of protein absorption. CNA was measured at baseline off of pancreatic enzymes and then again while on ten days of pancreatic enzyme supplementation. The change between CNA values at each timepoint was a study outcome.|Up to 10 days|3 subjects were not included in the final analysis. Two subjects did not accurately complete a three day dietary record in order to assess nitrogen intake. 1 subject submitted such a low volume of stool that it was assessed as an inaccurate and incomplete stool collection.|||percentage of nitrogen absorbed||Standard Deviation|Mean
2538556|NCT03097029|Primary|Change in Coefficient of Fat Absorption|Coefficient of fat absorption (CFA) measures the amount of fat excreted in the stool compared to how much fat was consumed over the course of 72 hours. This is a measure of fat absorption. CFA was measured at baseline off of pancreatic enzymes and then again while on ten days of pancreatic enzyme supplementation. The change between CFA values at each timepoint was the primary outcome.|Up to 10 days|3 subjects were not included in the analysis. Two of the subjects did not accurately complete dietary records in order to assess fat intake. One subject submitted such a low stool volume that it was assessed as unlikely to represent a full and accurate stool collection.|||percentage of fat absorbed||Standard Deviation|Mean
2538557|NCT03096873|Secondary|Maximal Heart Rate||12 weeks||||beats per minute||Standard Deviation|Mean
2538558|NCT03096873|Secondary|Diastolic Blood Pressure|Diastolic blood pressure was measured before and after 12 weeks.|12 weeks||||mmHg||Standard Deviation|Mean
2538559|NCT03096873|Secondary|Systolic Blood Pressure|Systolic blood pressure was measured before and after 12 weeks.|12 weeks||||mmHg||Standard Deviation|Mean
2538560|NCT03096873|Secondary|Arterial Stiffness|Brachial-ankle Pulse Wave Velocity (m/s) was measured using applanation tonometry before and after 12 weeks.|12 weeks||||meters per second (m/s)||Standard Deviation|Mean
2538561|NCT03096873|Secondary|Volume of Maximal Oxygen Consumption (VO2max)|Volume of maximal oxygen consumption (VO2max) was determined using a maximal treadmill test before and after 12 weeks.|12 weeks||||mL/kg/min of oxygen||Standard Deviation|Mean
2538562|NCT03096873|Primary|Adiponectin Levels in Micro Grams Per Milliliter|Adiponectin levels were measured before and after the training.|12 weeks||||ug/mL||Standard Deviation|Mean
2538563|NCT03096873|Primary|Leptin Levels in Nano Grams Per Milliliter|Leptin levels were measured before and after 12 weeks.|12 weeks||||ng/mL||Standard Deviation|Mean
2538564|NCT03096873|Primary|Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|Homeostasis model assessment of Insulin Resistance (HOMA-IR) was calculated before and after 12 weeks|12 weeks||||HOMA-IR Score||Standard Deviation|Mean
2538565|NCT03096873|Primary|Insulin Levels in Micro Unit Per Milliliter|Insulin levels were measured before and after 12 weeks.|12 weeks||||uU/mL||Standard Deviation|Mean
2538566|NCT03096873|Primary|Glucose Levels in Millimole Per Liter|Glucose levels were measured before and after 12 weeks.|12 weeks||||mmol/L||Standard Deviation|Mean
2538567|NCT03096873|Primary|Waist Circumference in Centimeters|Waist circumference was measured before and after 12 weeks.|12 weeks||||centimeters (cm)||Standard Deviation|Mean
2538568|NCT03096873|Primary|Lean Body Mass in Percents|Lean body mass was measured before and after 12 weeks.|12 weeks||||percent||Standard Deviation|Mean
2538569|NCT03096873|Primary|Body Fat in Percents|Body fat was measured before and after 12 weeks.|12 weeks||||percent||Standard Deviation|Mean
2538570|NCT03096873|Primary|BMI in Weight (Kilograms)/Height (Meters)^2|BMI was calculated with weight and height before and after 12 weeks.|12 weeks||||kilograms per meter squared (kg/m^2)||Standard Deviation|Mean
2538571|NCT03096873|Primary|Weight in Kilograms|Weight was measured before and after 12 weeks.|12 weeks||||kilograms (kg)||Standard Deviation|Mean
2538572|NCT03096873|Primary|Height in Meters|Height was measured before and after 12 weeks.|12 weeks||||meters||Standard Deviation|Mean
2538573|NCT03096483|Secondary|Number of Investigator Procedure Surveys Assessed by Survey Questionnaire|The total number of per subject survey completion reflecting the investigator opinion of procedures completed with the investigational device|2 months|Excludes 1 (one) withdrawn subject because subject was withdrawn prior to study procedures using mobile fluoroscopy.|||Procedure Survey Questionnaire|||Number
2538574|NCT03096483|Primary|Imaging Guidance Adequacy Assessed by Number of Questionnaires|Per-subject investigator report for procedure completion using the Investigational Device|2 Months|Excludes 1 (one) withdrawn subject because subject was withdrawn prior to study procedures using mobile fluoroscopy.|||Image Guidance Adequacy Questionnaire|||Number
2538575|NCT03096444|Secondary|Mechanical Thresholds (Mechanical Detection and Pain).|Assess mechanical detection and pain thresholds using von Frey filaments stimulators (measured in force mN) to calculate the final threshold as the geometric mean of five series of ascending and descending stimuli.|5 minutes|All subjects received treatment with the 5 topical cream formulations. Quantitative sensory testing was performed on each area of treated skin.|||mN||Standard Deviation|Mean
2538861|NCT03090958|Primary|Number of Individuals Who Enroll But do Not Participate|Feasibility of AllyQuest will be based on the number of individuals who enroll and do not participate.|4 weeks||||Participants|||Count of Participants
2538576|NCT03096444|Secondary|Thermal Threshold Detection (Warmth and Heat Pain)|Two standardized quantitative sensory tests are performed to measure warmth detection threshold (assesses the threshold of which warmth sensation is first detected) and heat pain threshold (assesses the threshold at which heat pain sensation is first detected). Measured in change in celsius.|3 minutes|All subjects received treatment with the 5 topical cream formulations. Quantitative sensory testing was performed on each area of treated skin.|||Degrees celsius||Standard Deviation|Mean
2538577|NCT03096444|Primary|Peak Itch Intensity Between the Vehicle and Active Treatments (Individual and KeAmLi-combo).|"Peak itch intensity between the vehicle and 4 other active treatments (individual ketamine, amitriptyline, or lidocaine, and KeAmLi-combo). Itch intensity was measured on a 100mm scale visual analog scale for 10 minutes. 0 was weighted with no itch and 100 was weighted with most itch imaginable."|10 minutes|All subjects received 5 topical cream treatments.|||Intensity score||Standard Deviation|Mean
2538578|NCT03096314|Secondary|Falls to Day 90|We assessed for incidence of falls by chart review at the end of hospitalization and by self-report at the 90 day phone call. Most data suggest that high dose vitamin D in healthy outpatients may improve muscle function, balance, and bone mineral density, and thus decrease fall-related fractures, but other data suggest that high dose vitamin D supplementation may actually increase the incidence of falls/fractures.|90 days post randomization|need to give info|||Participants|||Count of Participants
2538579|NCT03096314|Secondary|Fall-related Fractures to Day 90|Incident of fall-related fractures will be determined by chart review at the end of hospitalization and by self-report at day 90 phone call for those discharged from the hospital prior to day 90. Most data suggest that high dose vitamin D in healthy outpatients may improve muscle function, balance, and bone mineral density, and thus decrease fall-related fractures, but other data suggest that high dose vitamin D supplementation may actually increase the incidence of falls/fractures. Because of this uncertainty and limited data in hospitalized patients, we assessed for incident of fall-related fractures.|90 days after randomization||||Participants|||Count of Participants
2538580|NCT03096314|Secondary|Kidney Stones to Day 90|Incident of kidney stones determined by chart review at the end of hospitalization and by self-report at day 90 phone call in those discharged from the hospital prior to day 90.|90 days after randomization|Subjects discharged from the hospital prior to study day 90.|||Participants|||Count of Participants
2538581|NCT03096314|Secondary|Hypercalcemia to Day 14|As the half-life of 25OHD is approximately 2 weeks, clinically available serum or ionized calcium levels through study day 14 were collected. The number of participants with hypercalcemia was reported.|up to 14 days after randomization||||Participants|||Count of Participants
2538582|NCT03096314|Secondary|Highest Ionized Calcium to Day 14|Clinically available serum or ionized calcium levels through day 14 were collected for all randomized participants. This time frame was selected to align with the 25OHD half life of two weeks.|up to 14 days after randomization|Subjects with a clinically available ionized calcium level up to study day 14|||mg/dL||Standard Deviation|Mean
2538583|NCT03096314|Secondary|Highest Total Calcium to Day 14|Clinically available serum or ionized Ca levels were obtained through day 14 for all randomized patients. This time frame was selected to align with the 25OHD half life of two weeks.|14 days after randomization|Subjects with a clinically available total calcium level up to study day 14|||mg/dL||Standard Deviation|Mean
2538584|NCT03096314|Secondary|25OHD Levels at Day 3|Baseline levels will be measured using LC/MS/MS methods (all randomized participants) and at day 3 (the first 300 randomized participants only).|3 days after randomization||||ng/mL||Standard Deviation|Mean
2538585|NCT03096314|Secondary|Highest Cardiovascular SOFA (Sepsis Related Organ Failure Assessment) Score|"Cardiovascular score of the Organ SOFA score was used:~Score = 0: MAP* >= 70 mmHg and No Drug;~Score = 1: MAP < 70 mmHg and No Drug;~Score = 2: (Any MAP) ( dopamine<=5 OR any dobutamine ) AND no other drugs (include neosynephrine vasopressin);~Score = 3: (Any MAP) 5 < dopamine <= 15 OR epinephrine <= 0.1 OR norepinephrine <= 0.1 OR neosynephrine <=0.22 OR any dose vasopressin;~Score = 4: (Any MAP) dopamine > 15 OR epinephrine > 0.1 OR norepinephrine > 0.1 OR neosynephrine > 0.22~* MAP = mean arterial pressure"|Up to 7 days after randomization||||score on a scale||Standard Error|Mean
2538586|NCT03096314|Secondary|New Vasopressor Use to Day 7|The number of subjects in each arm that are started on a vasopressor after randomization up to study day 7.|Up to 7 days after randomization|need info on this|||Participants|||Count of Participants
2538587|NCT03096314|Secondary|Highest Creatinine Levels|The highest recorded creatinine values is taken from available levels reported across the 7 study days for each patient.|Up to 7 days after randomization||||mg/dL||Standard Error|Mean
2538588|NCT03096314|Secondary|New Renal Replacement Therapy (RRT)|Participants who were on chronic dialysis at baseline were excluded from the analysis. Participants who started renal replacement therapy on a study day after day 0 and inclusive of day 7 were considered as having new renal replacement therapy. Those who have never started renal replacement therapy over days 0-7 were considered as not having new renal replacement therapy.|Up to 7 days after randomization||||Participants|||Count of Participants
2538589|NCT03096314|Secondary|Worst Acute Kidney Injury (AKI)|This physiologic outcome is one of three key organ systems (respiratory, renal, and cardiovascular) used to assess change in organ failure severity from randomization up to study day 7. Worst AKI was determined by using highest daily creatinine values or new use of dialysis/ renal replacement therapy (chronic dialysis participants were excluded). Mild: On-study creatinine levels 1.5 times greater than baseline value or 0.3 mg/dL over the prehospital value. Moderate: On-study creatinine levels 2 times greater than the baseline pre-hospital value. Severe: On-study creatinine creatinine levels are 3 times greater than baseline prehospital value, or the on-study creatinine level is over 4 mg/dL with an acute (1 day) 0.5 mg/dL rise, or participant is on new renal replacement therapy.|Up to 7 days after randomization||||Participants|||Count of Participants
2538590|NCT03096314|Secondary|Severity of Acute Respiratory Distress Syndrome (ARDS)|Severity of ARDS is determined using the PaO2/FiO2 ratio or SpO2/FiO2 ratio and confirmation of ARDS through chest x-ray reviews. The breakout of mild to severe was categorized as P/F or imputed P/F ratio of 201-300 (mild), 100-200 (moderate), or less than 100 (severe). This physiologic outcome is one of three key organ systems (respiratory, renal, and cardiovascular) used to assess change in organ failure severity from randomization up to study day 7.|7 days after randomization|Those subjects that developed new ARDS after randomization were analyzed for severity.|||Participants|||Count of Participants
2538591|NCT03096314|Secondary|Number of Participants Who Developed (New) ARDS to Day 7|Presence of ARDS determined using the PaO2/FiO2 ratio or SpO2/FiO2 ratio (i.e., imputed P/F ratio) and chest x-ray confirmation. PaO2 = partial pressure of arterial oxygen; FiO2 = percentage of inspired oxygen; SpO2 = peripheral capillary oxygen saturation, an estimate of the amount of oxygen in the blood. For participants with P/F <300 or imputed P/F <300, FiO2 ≥40%, and PEEP ≥5 cm H2O, we determined if hypoxemia was valid, acute, and not fully explained by congestive heart failure (CHF) or fluid overload. PEEP = positive end expiatory pressure.|Up to 7 days after randomization||||Participants|||Count of Participants
2538592|NCT03096314|Secondary|Health-related Quality of Life by EuroQol (EQ-5D-5L)|Changes in Quality of life score by EuroQol from baseline to day 90. Change was calculated as the value at day 90 minus the value at baseline. The EuroQol score is based on 5 dimensions of perceived problems: Mobility, Self-Care, Anxiety/Depression, Pain/discomfort, and Usual Activities. Problems with each area are assigned a level from 1-5 with level 1 being no problem and level 5 indicating extreme problems. A unique health state score is defined by combining 1 level from each of the 5 dimensions. Responses can be used to calculate a health utility score55 associated with the given health state that ranges from -0.11 to 1.00 (higher scores are better; 1.00 is perfect health).|baseline to study day 90|Subjects alive and able to be contacted at study day 90 and who had a baseline EQ-5D-5L assessment were analyzed.|||score on a scale||Standard Deviation|Mean
2538593|NCT03096314|Secondary|Ventilator-free Days (VFDs) to Day 28|In participants who survive 28 days, ventilator free days (VFDs) is defined as 28 minus duration of ventilation. Duration of ventilation is counted from the first study day of assisted breathing through the last day of assisted breathing provided the last day is prior to day 28. Or it is counted from the first study day of assisted breathing through day 28. For participants discharged with assisted ventilation prior to day 28, a phone call will be required to assess ventilator status at day 28. Participants discharged prior to day 28 (but not to home) on unassisted breathing will be assumed to remain on unassisted breathing through day 28. Isolated periods of ventilation briefer than 24 hours for surgical procedures and ventilation solely for sleep disordered breathing do not count towards duration of ventilation. In participants who never require assisted breathing, duration of ventilation is zero. Participants who do not survive 28 days will be assigned zero VFD.|28 days after randomization|Excludes subjects who never required assisted breathing or who did not survive 28 days (considered zero vent free days).|||days||Standard Deviation|Mean
2538594|NCT03096314|Secondary|Healthcare Facility Length of Stay to Day 90|Healthcare facility length of stay is the time spent in another hospital or healthcare facility (e.g. long-term acute care [LTAC] hospitals or acute rehabilitation/skilled nursing facility), for the subgroup of participants that were discharged to another healthcare facility after the initial hospitalization. This measure is defined as the number of days from initial hospital discharge to the first facility discharge to home (pre-hospitalization level of care) up to day 90. Healthcare facility LOS is zero for patients discharged to home (pre-hospitalization level of care) from the study hospital. This endpoint will be analyzed only in survivors using SACE methods because healthcare facility length of stay in those who die during the follow-up period is non-informative for this endpoint.|90 days after randomization|This outcome was analyzed only in survivors using SACE methods because healthcare facility length of stay in those who die during the follow-up period is non-informative for this endpoint.|||days||Standard Deviation|Mean
2538595|NCT03096314|Secondary|Hospital Length of Stay to Day 90|Number of days from enrollment to the day of study hospital discharge up to day 90. Only calculated for patients that survived through day 90.|90 days after randomization||||days||Standard Deviation|Mean
2538596|NCT03096314|Secondary|Alive and Home (Prior Level of Care) at Day 90|This endpoint is the count of participants who have survived and are present at home, defined as pre-hospitalization level of care, at day 90.|90 days post randomization||||Participants|||Count of Participants
2538597|NCT03096314|Secondary|Hospital Mortality to Day 90|Analysis of the number of participants who died prior to hospital discharge up to study day 90.|Up to 90 days after randomization|Participant count is based on available data.|||participants|||Number
2538598|NCT03096314|Secondary|All-cause, All Location Mortality to Day 28|This variable was calculated in participants who were reported alive at day 28. Vital status of the patient at day 28 was determined using any of the following methods: medical record review, phone calls to patient, proxy or healthcare facility, or review of obituaries.|Up to 28 days after randomization||||participants|||Number
2538599|NCT03096314|Primary|All-cause, All-location Mortality to Day 90|Vital status of the patient at day 90 was determined using any of the following methods: medical record review, phone calls to patient, proxy or healthcare facility, review of obituaries, or information from the Centers for Disease Control and Prevention's National Death Index (NDI).|90 days after randomization|The primary analysis included subjects who had confirmed vitamin D deficiency by LC/MS/MS testing.|||Participants|||Count of Participants
2538600|NCT03095885|Secondary|Percent Change From Baseline for Urinary Oxalate to Creatinine Ratio by Test Interval|Urinary oxalate (UOx) excretion was normalized to units of mg/g creatinine by dividing the UOx in mg by the creatinine value in g from the same collection. Percent change from baseline for UOx/Cr from Baseline was calculated by 100 * [UOx/Cr for the test interval - UOx/Cr at Baseline] / UOx/Cr at Baseline.|24 hours during baseline, 0 to 4 hours post test meal, 0-6 hours post test meal, 6-24 hours post test meal, 0-24 hours post test meal|Enrolled set which included all enrolled subjects|||Percentage of change of UOx/Cr||Standard Deviation|Mean
2538601|NCT03095885|Secondary|Percent of Oxalate Absorption By Test Interval|Percent of Oxalate absorption by test interval was calculated as the urinary oxalate excretions (mg) during the test interval divided by the amount of oxalate in the test meal.|0-4 hours post test meal, 0-6 hours post test meal, 0-24 hours post test meal|Enrolled set which included all enrolled subjects|||percentage of oxalate absorption||Standard Deviation|Mean
2538602|NCT03095885|Primary|Percent of Oxalate Absorption Normalized by Baseline Urinary Oxalate Excretion Over a 24 Hour Test Period|Percent of oxalate absorption normalized by baseline was calculated by 100*[UOx/test - UOx/baseline]/Ox intake from the test meal.|24 hours during baseline and test day following oxalate-rich meal|Enrolled set which included all enrolled subjects|||percentage of oxalate absorption||Standard Deviation|Mean
2538862|NCT03090958|Primary|Average Number of Days Participants Logged in.|Feasibility of AllyQuest will be based on usage as measured by the average number days participants access the app.|4 weeks|Missing data on 3 participants, hence only reporting data on 17 participants.|||days||Standard Deviation|Mean
2538603|NCT03095651|Secondary|Apparent Terminal Half-life|Apparent Terminal Half-life (t1/2) is the time required for a given MK-5160 concentration in the plasma to decrease by 50%.|Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.|All participants that received MK-5160, had no major protocol violations, and had t1/2 values available on Day 1 and Day 12. t1/2 was not calculated for the Glargine 0.4 U/kg and 0.6 U/kg arms. No participants were randomized to the T1DM MK-5160 64 nmol/kg or T2DM MK-5160 16 nmol/kg arms.|||hour||Geometric Coefficient of Variation|Geometric Mean
2538604|NCT03095651|Secondary|Time to Maximum Plasma Concentration|Time to reach the maximum plasma concentration (Tmax) of study drug after the dose is given.|Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.|All participants that received study drug, had no major protocol violations, and had Tmax values available on Day 1 and Day 12. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.|||hour||Full Range|Median
2538605|NCT03095651|Secondary|Plasma Clearance|Plasma Clearance (CL) of study drug is the volume of plasma cleared of study drug per unit time.|Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.|All participants that received study drug, had no major protocol violations, and had CL values available on Day 12. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.|||L/hr/kg||95% Confidence Interval|Geometric Mean
2538606|NCT03095651|Secondary|Day 12 to Day 1 Accumulation Ratio of AUC0-24.|Day 12 to Day 1 Accumulation Ratio (AR) of the AUC0-24 of study drug (MK-5160 or glargine). Geometric mean accumulation ratio = Day 12 AUC0-24/Day 1 AUC0-24|Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI.|Participants with AUC0-24 measurements on Day 1 and Day 12. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.|||Ratio||90% Confidence Interval|Geometric Mean
2538607|NCT03095651|Secondary|Plasma Concentration/Time (AUC0-24) of Glargine|AUC0-24 is a measure of the total amount of glargine in the plasma from the dose administration to 24 hours. MK-5160 data are presented in the preceding outcome measure.|Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI.|All participants that received glargine, had no major protocol violations, and had AUC0-24 values available on Day 1 and Day 12.|||hr*pmol/L||95% Confidence Interval|Geometric Mean
2538608|NCT03095651|Secondary|Plasma Concentration/Time (AUC0-24) of MK-5160|Area Under the Plasma Concentration/Time Curve for MK-5160 from Time 0 to 24 hours (AUC0-24) is a measure of the total amount of MK-5160 in the plasma from the dose administration to 24 hours. Glargine data are presented in the following outcome measure.|Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI.|All participants that received MK-5160, had no major protocol violations, and had AUC0-24 values available on Day 1 and Day 12. No participants were randomized to the T1DM MK-5160 64 nmol/kg or T2DM MK-5160 16 nmol/kg arms. One participant in the T2DM MK-5160 32 nmol/kg arm withdrew consent after receiving a single dose of study drug.|||hr*nM||95% Confidence Interval|Geometric Mean
2538609|NCT03095651|Secondary|Steady State Plasma Concentration (Css) of Glargine|"Css of glargine is the amount of glargine in a given volume of plasma at the time a steady state has been achieved, and rates of glargine administration and glargine elimination are equal. MK-5160 data are presented in the preceding outcome measure."|Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.|All participants that received glargine, had no major protocol violations, and had Css values available on Day 12.|||pmol/L||95% Confidence Interval|Geometric Mean
2538610|NCT03095651|Secondary|Steady State Plasma Concentration (Css) of MK-5160|"Css of MK-5160 is the amount of MK-5160 in a given volume of plasma at the time a steady state has been achieved, and rates of MK-5160 administration and MK-5160 elimination are equal. Glargine data are presented in the following outcome measure."|Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.|All participants that received MK-5160, had no major protocol violations, and had Css values available on Day 12. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.|||nM||95% Confidence Interval|Geometric Mean
2538611|NCT03095651|Secondary|Day 12 to Day 1 Accumulation Ratio of Cmax|Day 12 to Day 1 accumulation ratio (AR) of Cmax of MK-5160 and glargine following multiple dose administration of study drug. Geometric mean accumulation ratio = Day 12 Cmax/Day 1 Cmax.|Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.|Participants with Cmax measurements on Day 1 and Day 12. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.|||Ratio||90% Confidence Interval|Geometric Mean
2538612|NCT03095651|Secondary|Maximum Plasma Concentration (Cmax) of Glargine|Cmax of glargine following multiple dose administration of study drug. MK-5160 data are presented in the preceding outcome measure.|Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours FSOI. Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.|All participants that received glargine, had no major protocol violations, and had Cmax values available on Day 1 and Day 12.|||pmol/L||95% Confidence Interval|Geometric Mean
2538613|NCT03095651|Secondary|Maximum Plasma Concentration (Cmax) of MK-5160|Cmax of MK-5160 following multiple dose administration of study drug. Glargine data are presented in the following outcome measure.|Day 1 clamp: -15 min. (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours following start of injection (FSOI). Day 12: -15 min (predose), 10, 30 min., 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, and 168 hours FSOI.|All participants that received MK-5160, had no major protocol violations, and had Cmax values available on Day 1 and Day 12. No participants were randomized to the T1DM MK-5160 64 nmol/kg or T2DM MK-5160 16 nmol/kg arms. One participant in the T2DM MK-5160 32 nmol/kg arm withdrew consent after receiving a single dose of study drug.|||nM||95% Confidence Interval|Geometric Mean
2538614|NCT03095651|Primary|Maximal Glucose Infusion Rate|Maximal glucose infusion rate required to maintain target glucose levels in a euglycemic clamp setting (GIRmax) at steady state (Day 12) following administration of study drug. In cases where the lower bound of the CI was negative, the lower confidence limit was truncated at zero. In these cases, the confidence intervals are 97.5% CIs.|Up to 24 hours post-dose on Day 12|All participants that received study drug, had no major protocol violations, and had GIRmax values available on Day 12. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.|||mg/kg/min||95% Confidence Interval|Mean
2538615|NCT03095651|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 12 days|All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.|||Participants|||Count of Participants
2538616|NCT03095651|Primary|Number of Participants Experiencing an Adverse Event (AE)|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 33 days|All participants who received at least one dose of study drug. No participants were randomized to the T1DM MK-5160 64 nmol/kg arm or the T2DM MK-5160 16 nmol/kg arm.|||Participants|||Count of Participants
2538617|NCT03095638|Secondary|Number of Participants With Urinalysis Toxicities of Grade 2 as Defined by DAIDS for Part 1|The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life threatening, low LDL and HDL Data has been presented for urinalysis laboratory result parameter (urine protein by dipstick analysis) with toxicity of Grade 2 for Part 1.|Up to 25 days in Part 1|All Subjects Population|||Participants|||Number
2538618|NCT03095638|Secondary|Number of Participants With Chemistry Toxicities of Grade 2 as Defined by Division of Acquired Immunodeficiency Syndrome (DAIDS) for Part 1|The DAIDS toxicity table provides descriptive terminology for grading the severity of adult adverse events. Laboratory grades also provide ranges for each parameter. Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life threatening. low LDL (low-density lipid); HDL (high-density lipid). Data has been presented for clinical chemistry laboratory result parameter (serum sodium) with toxicity of Grade 2 for Part 1.|Up to 25 days in Part 1|All Subjects Population|||Participants|||Number
2538619|NCT03095638|Secondary|Urine Specific Gravity Analysis by Dipstick Method for Part 2|Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up-to follow-up (Day 36) in Part 2. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Up to 36 days in Part 2|All Subjects Population|||Ratio||Standard Deviation|Mean
2538620|NCT03095638|Secondary|Urine pH Analysis by Dipstick Method for Part 2|Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by dipstick method up-to follow-up (Day 36) in Part 2. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles).|Up to 36 days in Part 2|All Subjects Population|||Points on a scale||Standard Deviation|Mean
2538621|NCT03095638|Secondary|Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 2|Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood and urine protein. In this dipstick test, the level of ketones, glucose, occult blood and protein in urine samples was recorded as negative trace, 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (Day 36) in Part 2. Only categories with significant values have been presented.|Up to 36 days in Part 2|All Subjects Population|||Participants|||Number
2538622|NCT03095638|Secondary|Urine Specific Gravity Analysis by Dipstick Method for Part 1|Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected for the measurement of urine specific gravity by dipstick method up-to follow-up (Day 25) in Part 1. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles).|Up to 25 days in Part 1|All Subjects Population|||Ratio||Standard Deviation|Mean
2538623|NCT03095638|Secondary|Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part 1|Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by dipstick method up-to follow-up (Day 25) in Part 1. Only categories with significant values have been presented. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles).|Up to 25 days in Part 1|All Subjects Population|||Points on a scale||Standard Deviation|Mean
2538655|NCT03095638|Secondary|Tmax of DTG for Part 2|Blood sample were collected at the indicated time points after administration of study treatment to investigate the pharmacokinetic profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2|PK Population|||hours||Full Range|Median
2538624|NCT03095638|Secondary|Number of Participants With Abnormal Values on Urinalysis by Dipstick Method for Part 1|Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood and urine protein. In this dipstick test, the level of ketones, glucose, occult blood and protein in urine samples was recorded as negative trace, 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (Day 25) in Part 1. Only categories with significant values have been presented.|Up to 25 days in Part 1|All Subjects Population|||Participants|||Number
2538625|NCT03095638|Secondary|Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 2|Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocytes results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles).|Baseline and up to 36 days in Part 2|All Subjects Population|||10^12 cells/Liter||Standard Deviation|Mean
2538626|NCT03095638|Secondary|Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2|Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hematocrit results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles)|Baseline and up to 36 days in Part 2|All Subjects Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
2538627|NCT03095638|Secondary|Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 2|Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hemoglobin results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles)|Baseline and up to 36 days in Part 2|All Subjects Population|||g/L||Standard Deviation|Mean
2538628|NCT03095638|Secondary|Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils,, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 2|Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils, blood platelets results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles)|Baseline and up to 36 days in Part 2|All Subjects Population|||10^9 cells/Liter||Standard Deviation|Mean
2538629|NCT03095638|Secondary|Change From Baseline in Hematology Parameter Blood Erythrocyte MCV for Part 2|Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCV results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles).|Baseline and up to 36 days in Part 2|All Subjects Population|||fL||Standard Deviation|Mean
2538630|NCT03095638|Secondary|Change From Baseline in Hematology Parameter Blood Erythrocyte MCH for Part 2|Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCH results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x,x,x in the category titles).|Baseline and up to 36 days in Part 2|All Subjects Population|||pg||Standard Deviation|Mean
2538631|NCT03095638|Secondary|Change From Baseline in Hematology Parameter Blood Erythrocytes for Part 1|Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles).|Baseline and up to 25 days in Part 1|All Subjects Population|||10^12 cells/Liter||Standard Deviation|Mean
2538632|NCT03095638|Secondary|Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1|Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hematocrit results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles).|Baseline and up to 25 days in Part 1|All Subjects Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
2538633|NCT03095638|Secondary|Change From Baseline in Hematology Parameter Blood Hemoglobin for Part 1|Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood hemoglobin results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles)|Baseline and up to 25 days in Part 1|All Subjects Population|||g/L||Standard Deviation|Mean
2538740|NCT03092791|Secondary|Vaccine Response Rate (VRR) on Day 393 in Infant Dose Ranging Cohort|VRR is defined as percentage of participants i) seronegative prior to booster vaccination (titer <8) having a titer ≥8, or ii) seropositive prior to booster vaccination (titer ≥8) having a 4-fold rise in antibody titers.|Day 393|As the study was early terminated the data was not collected at Day 393 for Vaccine Response Rate.||||||
2538634|NCT03095638|Secondary|Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils, Blood Platelets for Part 1|Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils, blood platelets results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles)|Baseline and up to 25 days in Part 1|All Subjects Population|||10^9 cells/Liter||Standard Deviation|Mean
2538635|NCT03095638|Secondary|Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Volume (MCV) for Part 1|Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCV results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x,x in the category titles).|Baseline and up to 25 days in Part 1|All Subjects Population|||Femtoliters (fL)||Standard Deviation|Mean
2538636|NCT03095638|Secondary|Change From Baseline in Hematology Parameter Blood Erythrocyte Mean Corpuscular Hemoglobin (MCH) for Part 1|Blood samples for the assessment of hematology parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for blood erythrocyte MCH results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 25 days in Part 1|All Subjects Population|||Picograms (pg)||Standard Deviation|Mean
2538637|NCT03095638|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatine and Serum Direct Bilirubin for Part 2|Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum bilirubin, serum creatine and serum direct bilirubin results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 36 days in Part 2|All Subjects Population|||umol/L||Standard Deviation|Mean
2538638|NCT03095638|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2|Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum albumin and serum protein results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 36 days in Part 2|All Subjects Population|||g/L||Standard Deviation|Mean
2538639|NCT03095638|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum Alkaline Phosphate, Serum AST, Serum Creatine Kinase for Part 2|Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum ALT, serum alkaline phosphatase, serum AST, serum creatine kinase results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 36 days in Part 2|All Subjects Population|||IU/L||Standard Deviation|Mean
2538640|NCT03095638|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 2|Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 36) in Part 2. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum glucose, serum calcium, serum potassium, serum sodium, serum urea results for Part 2. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 36 days in Part 2|All Subjects Population|||mmol/L||Standard Deviation|Mean
2538641|NCT03095638|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1|Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum bilirubin, serum creatinine and serum direct bilirubin results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 25 days in Part 1|All Subjects Population|||micromoles/liter (umol/L)||Standard Deviation|Mean
2538642|NCT03095638|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1|Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum albumin and serum protein results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 25 days in Part 1|All Subjects Population|||Grams/liter (g/L)||Standard Deviation|Mean
2538656|NCT03095638|Secondary|Plasma DTG Tlag for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2|PK Population|||hours||Full Range|Median
2545594|NCT02940327|Primary|CD16/41|Change of markers of platelet and leukocyte activation in arterial blood and analysed by flow cytometry.|12 hours after ECMO commencement||||percent change||Standard Deviation|Mean
2538643|NCT03095638|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum Alanine Amino Transferase (ALT), Serum Alkaline Phosphatase, Serum Aspartate Amino Transferase (AST), Serum Creatine Kinase for Part 1|Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum ALT, serum alkaline phosphatase, serum AST, serum creatine kinase results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 25 days in Part 1|All Subjects Population|||International units/liter (IU/L)||Standard Deviation|Mean
2538644|NCT03095638|Secondary|Change From Baseline in Clinical Laboratory Parameters Serum Glucose, Serum Calcium, Serum Potassium, Serum Sodium, Serum Urea for Part 1|Blood samples for the assessment of chemistry parameters were collected at Baseline and up-to follow-up (Day 25) in Part 1. Baseline was defined as pre-dose assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Data has been presented for serum glucose, serum calcium, serum potassium, serum sodium, serum urea results for Part 1. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 25 days in Part 1|All Subjects Population|||millimoles/liter (mmol/L)||Standard Deviation|Mean
2538645|NCT03095638|Secondary|Number of Participants With Adverse Events AEs and Serious Adverse Events SAEs for Part 2|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Data has been presented for AEs and SAEs up-to follow-up (36 days) in Part 2.|Up to 36 days in Part 2|All Subjects Population|||Participants|||Number
2538646|NCT03095638|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Data has been presented for AEs and SAEs up-to follow-up (25 days) in Part 1. All Subjects Population was defined as all participants who received at least 1 dose of study medication.|Up to 25 days in Part 1|All Subjects Population|||Participants|||Number
2538647|NCT03095638|Secondary|C24 of DTG for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2|PK Population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2538648|NCT03095638|Secondary|Ct of DTG for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2|PK Population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2538649|NCT03095638|Secondary|Vz/F of DTG for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2|PK Population|||Liters||Geometric Coefficient of Variation|Geometric Mean
2538650|NCT03095638|Secondary|DTG CL/F for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2|PK Population|||Liters/hour||Geometric Coefficient of Variation|Geometric Mean
2538651|NCT03095638|Secondary|AUC (0-24) of DTG for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2|PK Population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2538652|NCT03095638|Secondary|%AUCex of DTG for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2|PK Population|||Percentage of AUC||95% Confidence Interval|Mean
2538653|NCT03095638|Secondary|Lambda Z of DTG for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2|PK Population|||per hour||Geometric Coefficient of Variation|Geometric Mean
2538654|NCT03095638|Secondary|t1/2 of DTG for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2|PK Population|||hours||Geometric Coefficient of Variation|Geometric Mean
2538657|NCT03095638|Secondary|Observed Concentration at 24 Hours After Dose Administration (C24) of DTG for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1|PK Population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2538658|NCT03095638|Secondary|Last Observed Quantifiable Concentration (Ct) of DTG for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1|PK Population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2538659|NCT03095638|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/F) of DTG for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1|PK Population|||Liters||Geometric Coefficient of Variation|Geometric Mean
2538660|NCT03095638|Secondary|Apparent Oral Clearance (CL/F) of DTG for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times..|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1|PK Population|||Liters/hour||Geometric Coefficient of Variation|Geometric Mean
2538661|NCT03095638|Secondary|Area Under the Concentration-time Curve Over Time Zero (Pre-dose) to 24 Hours After Dose Administration (AUC[0-24]) of DTG for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1|PK Population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2538662|NCT03095638|Secondary|Percentage of AUC (0-infinity) Obtained by Extrapolation (%AUCex) of DTG for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1|PK Population|||Percentage of AUC||95% Confidence Interval|Mean
2538663|NCT03095638|Secondary|Terminal-phase Rate Constant (Lambda z) of DTG for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1|PK Population|||per hour||Geometric Coefficient of Variation|Geometric Mean
2538664|NCT03095638|Secondary|Terminal Phase Half-life (t1/2) of DTG for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1|PK population|||hours||Geometric Coefficient of Variation|Geometric Mean
2538665|NCT03095638|Secondary|Time to First Occurrence of Cmax (Tmax) of DTG for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1|PK Population|||hours||Full Range|Median
2538666|NCT03095638|Secondary|Plasma DTG Lag Time Before Observation of Drug Concentrations (Tlag) for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1|PK Population|||hours||Full Range|Median
2538667|NCT03095638|Secondary|Cmax of DTG for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2|PK Population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2538668|NCT03095638|Secondary|AUC (0-t) of DTG for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2|PK Population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2538669|NCT03095638|Primary|AUC (0-infinity) of DTG for Part 2|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times..|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 2|PK population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2538715|NCT03094806|Secondary|Analysis of Change in Daily Sputum Production|Sputum production in a 24 hour period in mL volume|Up to 5 days||||volume in mL||Standard Deviation|Mean
2538670|NCT03095638|Primary|Maximum Observed Concentration (Cmax) of DTG for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1|PK Population|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2538671|NCT03095638|Primary|Area Under the Plasma Concentration-time Curve From Time of Dose to Last Measurable Concentration AUC [0-t] of DTG for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the PK profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times..|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1|PK Population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2538672|NCT03095638|Primary|Area Under the Plasma Concentration-time Curve From Time of Dose Extrapolated to Infinite Time (AUC[0-infinity]) of DTG for Part 1|Blood samples were collected at the indicated time points after administration of study treatment to investigate the pharmacokinetic (PK) profile of DTG tablets in fasted state. PK parameters were calculated by standard non-compartmental analysis using Phoenix WinNonlin Version 6.4 or higher based on actual sampling times. The PK Population was defined as participants in the All Subjects Population for whom a PK sample was obtained and that had evaluable PK assay results.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 48, and 72 hours post-dose in Part 1|PK Population|||hours*nanograms/mL (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2538673|NCT03095599|Secondary|Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer|Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine (A/H1N1, B, and A/H3N2). This testing was performed by VisMederi SRL laboratory (Siena, Italy), by using a validated assay. Sample collection on Day 1 was prior to administration of study product.|Day 1, Day 22|Phase 3 participants who were participated in the study through at least day 22, overall and by age group.|||fold change||Standard Deviation|Geometric Mean
2538674|NCT03095599|Secondary|Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 46-60|Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine (A/H1N1, B, and A/H3N2). This testing was performed by VisMederi SRL laboratory (Siena, Italy), by using a validated assay. Sample collection on Day 1 was prior to administration of study product.|Day 1, Day 22|Phase 3 participants who were age 46-60 and participated in the study through at least day 22.|||titer||Standard Deviation|Geometric Mean
2538675|NCT03095599|Secondary|Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 18-45|Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine (A/H1N1, B, and A/H3N2). This testing was performed by VisMederi SRL laboratory (Siena, Italy), by using a validated assay. Sample collection on Day 1 was prior to administration of study product.|Day 1, Day 22|Phase 3 participants who were age 18-45 and participated in the study through at least day 22.|||titer||Standard Deviation|Geometric Mean
2538676|NCT03095599|Secondary|Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: All Subjects|Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine (A/H1N1, B, and A/H1N1). This testing was performed by VisMederi SRL laboratory (Siena, Italy), by using a validated assay. Sample collection on Day 1 was prior to administration of study product.|Day 1, Day 22|Phase 3 participants who were participated in the study through at least day 22.|||titer||Standard Deviation|Geometric Mean
2538677|NCT03095599|Secondary|Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer|Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine (A/H1N1, B, and A/H3N2). This testing was performed by VisMederi SRL laboratory (Siena, Italy), by using a validated assay. Sample collection on Day 1 was prior to administration of study product.|Day 22|Phase 3 participants who were participated in the study through at least day 22, overall and by age group.|||Participants|||Count of Participants
2538678|NCT03095599|Primary|Geometric Mean Fold Change of Serum Hemagglutination Inhibition (HAI) Antibody Titer, Overall and by Age Group|Fold change in titer between Day 1 and Day 22. Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine (A/H1N1, B, and A/H3N2). This testing was performed by VisMederi SRL laboratory (Siena, Italy), by using a validated assay. Sample collection on Day 1 was prior to administration of study product.|Day 1, Day 22|Phase 3 participants who were participated in the study through at least day 22, overall and by age group.|||fold change||95% Confidence Interval|Geometric Mean
2538679|NCT03095599|Primary|Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group|Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine (A/H1N1, B, and A/H3N2). This testing was performed by VisMederi SRL laboratory (Siena, Italy), by using a validated assay. Sample collection on Day 1 was prior to administration of study product.|Day 1, Day 22|Phase 3 participants who were participated in the study through at least day 22, overall and by age group.|||titer||95% Confidence Interval|Geometric Mean
2538680|NCT03095599|Primary|Number and Percentage of Subjects With Seroconversion of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens, Overall and by Age Group|"Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine (A/H1N1, B, and A/H3N2). This testing was performed by VisMederi SRL laboratory (Siena, Italy), by using a validated assay. Sample collection on Day 1 was prior to administration of study product.~Seroconversion is defined as a serum HAI antibody titer meeting the following criteria:~pre-vaccination titer < 1:10 and a post-vaccination titer measured on Day 22 of ≥ 1:40, or~pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination measured on Day 22"|Day 1, Day 22|Phase 3 participants who were participated in the study through at least day 22, overall and by age group.|||Participants|||Count of Participants
2538681|NCT03095599|Primary|Number and Percentage of Subjects Experiencing Unsolicited Serious Adverse Events (SAE)|"Unsolicited AEs were observed by study staff while the subject is at a clinic for a study visit or reported by the subject at any time. Any sign or symptom that would normally be considered a solicited AE (for example, fever, nausea, injection site pain) starting after 7 days post-vaccination was to be recorded as an unsolicited AE. The clinician determined whether there was a reasonable possibility that the investigational product(s) caused or contributed to an AE. The following guidelines were used:~Related: There is a reasonable possibility that the study vaccine caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE.~Not Related: There is not a reasonable possibility that the administration of the study product caused the event."|Day 1 to Day 91|All recipients of the vaccine in Phases 2 and 3|||Participants|||Count of Participants
2538682|NCT03095599|Primary|Number and Percentage of Subjects Experiencing Unsolicited Adverse Events (AE)|"Unsolicited AEs were observed by study staff while the subject is at a clinic for a study visit or reported by the subject at any time. Any sign or symptom that would normally be considered a solicited AE (for example, fever, nausea, injection site pain) starting after 7 days post-vaccination was to be recorded as an unsolicited AE. The clinician determined whether there was a reasonable possibility that the investigational product(s) caused or contributed to an AE. The following guidelines were used:~Related: There is a reasonable possibility that the study vaccine caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE.~Not Related: There is not a reasonable possibility that the administration of the study product caused the event."|Day 1 to Day 21|All recipients of the vaccine in Phases 2 and 3|||Participants|||Count of Participants
2538683|NCT03095599|Primary|Number and Percentage of Subjects Experiencing Fever|Subjects reporting body temperature by maximum severity; Grade 0: <38°C, Grade 1: 38.0 - <38.6°C, Grade 2: 38.6 - <39.3°C, Grade 3: 39.3 - <40.0°C, Grade 4: >= 40.0°C|Day 1 to Day 7|All recipients of the vaccine in Phases 2 and 3|||Participants|||Count of Participants
2538684|NCT03095599|Primary|Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity|"Solicited systemic AEs were assessed by study staff 30 minutes after vaccination then daily for 7 days by the subjects. Subjects were provided a thermometer, ruler and a diary to record the presence or absence of solicited AEs, severity of the solicited AE and use of concomitant medication. AEs were graded as follows:~Mild: Mild symptoms causing no or minimal interference with usual social and functional activities with intervention not indicated.~Moderate: Moderate symptoms causing greater than minimal interference with usual social and functional activities with intervention indicated.~Severe: Severe symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated.~Life-threatening: Potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death."|Day 1 to Day 7|All recipients of the vaccine in Phases 2 and 3|||Participants|||Count of Participants
2538685|NCT03095599|Primary|Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity|"Solicited local AEs were assessed by study staff 30 minutes after vaccination then daily for 7 days by the subjects. Subjects were provided a thermometer, ruler and a diary to record the presence or absence of solicited AEs, severity of the solicited AE and use of concomitant medication. AEs were graded as follows:~Mild: Mild symptoms causing no or minimal interference with usual social and functional activities with intervention not indicated.~Moderate: Moderate symptoms causing greater than minimal interference with usual social and functional activities with intervention indicated.~Severe: Severe symptoms causing inability to perform usual social and functional activities with intervention or hospitalization indicated.~Life-threatening: Potentially life-threatening symptoms causing inability to perform basic self-care functions with intervention indicated to prevent permanent impairment, persistent disability, or death."|Day 1 to Day 7|All recipients of the vaccine in Phases 2 and 3|||Participants|||Count of Participants
2538686|NCT03095599|Primary|Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE)|Solicited systemic AEs were assessed by study staff 30 minutes after vaccination.|Within 30 minutes of vaccination|All recipients of the vaccine in Phases 2 and 3|||Participants|||Count of Participants
2538687|NCT03095599|Primary|Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE)|Solicited local AEs were assessed by study staff 30 minutes after vaccination.|Within 30 minutes of vaccination|All recipients of the vaccine in Phases 2 and 3|||Participants|||Count of Participants
2538688|NCT03095521|Secondary|Change From Baseline in Sore Throat Intensity by 100 mm in Visual Analogue Scale Filled in by the Patient (VAS) .|"The VAS is a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of no pain at all and worst pain imaginable. The VAS ranges from 0 to 100. A decrease from baseline in the VAS score to reflect pain intensity indicates a decrease in pain intensity."|baseline, day 4|PP, participants with measure|||millimeters||Standard Deviation|Mean
2538689|NCT03095521|Secondary|Number of Participants Who Fully Recovered up to Day 5|Number of participants who fully recovered up to day 5 (the outcome of a disease according to the objective evaluation by the Investigator, the total score according to the TSS questionnaire ≤ 2)|4 days for Angal, 5 days for AntiAngin|PP|||participants|||Number
2538690|NCT03095521|Secondary|Days to Recovery, Defined by the Patient's Diary (Subjective Evaluation by the Patient)|only patients for which outcomes were available were included , 111 out of 113 for Angal and 102 out of 107 for Antiangin, per protocol set|5 days|PP|||days||Standard Error|Mean
2538691|NCT03095521|Secondary|Change From Baseline in TSS Total Score|"Change from baseline in TSS total score. A negative change from baseline means an improvement.TSS (Tonsillopharyngitis Severity Score) is a questionnaire for evaluation of the five following symptoms severity: pharyngalgia, difficulty in swallowing, salivation, hyperemia of pharyngeal mucosa, and body temperature increase according to a 4-point scale:~0 : no symptoms~: insignificant symptom~: moderate symptom~: significant symptom fever~0 pts : <37.5 °С;~pts : 37.5 to <38.5 °С;~pts : 38.5 to <39.5 °С;~pts : ≥ 39.5 °С. TSS total ranges are 0-15."|baseline and day 4|PP|||unit on a scale||Full Range|Mean
2538692|NCT03095521|Secondary|50% Reduction Tss SCORE|Frequency of 50 % or more total score reduction by the TSS questionnaire completed by the Investigator relative to baseline in both Angal and ANTI-ANGIN FORMULA arms at visit 2|day 4|PP set was considered for the analysis, however only the number of patients with complete data at visit 2 were considered for the analysis|||percentage of participants||95% Confidence Interval|Number
2538693|NCT03095521|Primary|Percentage of Participants Without Sore Throat According to TSS Score|"TSS (Tonsillopharyngitis Severity Score) is a questionnaire for evaluation of the five following symptoms severity: pharyngalgia, difficulty in swallowing, salivation, hyperemia of pharyngeal mucosa, and body temperature increase according to a 4-point scale:~0 : no symptoms~: insignificant symptom~: moderate symptom~: significant symptom fever~0 pts : <37.5 °С;~pts : 37.5 to <38.5 °С;~pts : 38.5 to <39.5 °С;~pts : ≥ 39.5 °С. TSS total ranges are 0-15."|4 days|ITT, only patients with measurements were included (115 for Angal, and 112 for Antiangin)|||percentage of participants|||Number
2538694|NCT03095508|Primary|Percentage of Patients Without Sore Throat According to the Tonsillopharyngitis Severity Score (TSS)|"The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms:~throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15."|4 Days|ITT Population|||Percentage of Participants|||Number
2538695|NCT03095508|Secondary|Period of Time Required for Disappearance of the Disease Symptoms|A period of time required for disappearance of the disease symptoms, determined according to the patient's diary (subjective patient's evaluation), but no more than 5 days during the trial—for patients who have achieved the corresponding outcome.|5 Days|ITT Population (only cases with disappearance of symptoms within 5 days)|||Days||Standard Deviation|Mean
2538696|NCT03095508|Secondary|Change in the Sore Throat Intensity by 100 mm VAS|"Change in the sore throat intensity by 100 mm VAS (visual analogue scale filled in by the patient) at the start and after 3 days of therapy. The VAS is a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of no pain at all and worst pain imaginable. The VAS ranges from 0 to 100. A decrease from baseline in the VAS score to reflect pain intensity indicates a decrease in pain intensity."|4 days|ITT population|||mm||Standard Deviation|Mean
2538697|NCT03095508|Secondary|Number of Participants Who Fully Recovered|Number of Participants who Fully Recovered by Day 4 in Group A and by Day 5 in Group B (the outcome of a disease according to the objective evaluation by the Investigator, the total score according to the TSS questionnaire ≤ 2)|Group A: 4 days Group B: 5 days|ITT population|||Participants|||Count of Participants
2538698|NCT03095508|Secondary|Change From Baseline in TSS Total Score|"Change from baseline in TSS total score completed by the Investigator as compared to the baseline.~The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms:~throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15."|4 days|ITT population|||units on a scale||Full Range|Median
2538699|NCT03095508|Secondary|Percentage of Participants With a ≥50% TSS Total Score Reduction|"Percentage of participants with a ≥50% TSS Total Score Reduction according to the TSS questionnaire completed by the Investigator as compared to the baseline.~The Tonsillopharyngitis Severity Score (TSS) scale consists of the following symptoms:~throat pain, difficulty in swallowing, salivation, erythema and fever rated on a 4-point scale (0 = no symptom to 3 = significant symptom). Total score range from 0 - 15."|4 days|ITT Population|||percentage of participants||95% Confidence Interval|Number
2538700|NCT03095456|Secondary|Summary of Rescue Medication Use: Puffs Per Day||1 Month||||puffs per day||Standard Error|Least Squares Mean
2538701|NCT03095456|Secondary|Change From Baseline Peak FVC on Day 29||Baseline and Day 29 (0-4 hours)||||mL||Standard Error|Least Squares Mean
2538702|NCT03095456|Secondary|Change From Baseline Peak FEV1 on Day 29||Baseline and Day 29 (0-4 hours)||||mL||Standard Error|Least Squares Mean
2538703|NCT03095456|Secondary|Change From Baseline Trough Inspiratory Capacity (IC) on Day 29||Baseline and Day 29||||mL||Standard Error|Least Squares Mean
2538704|NCT03095456|Secondary|Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29||Baseline and Day 29||||mL||Standard Error|Least Squares Mean
2538705|NCT03095456|Primary|Change From Baseline in Trough FEV1 on Day 29|FEV1 = forced expiratory volume at one second|Baseline and Day 29|Intent-to-treat (ITT) analysis set|||mL||Standard Error|Least Squares Mean
2538706|NCT03095053|Secondary|The Percentage of Pregnancies That Miscarried|A miscarriage was defined as the loss of a clinical pregnancy before 20 weeks of gestation.|<20 weeks|The miscarriage rates in the study trial groups|||Participants|||Count of Participants
2538707|NCT03095053|Secondary|The Percentage of Patients With a Clinical Pregnancy|A clinical pregnancy was defined as a cycle with a fetal sac observed on ultrasound after 5 weeks of gestation|>5 weeks of gestation|The clinical pregnancy rates in the study trial groups|||Participants|||Count of Participants
2538708|NCT03095053|Primary|The Percentage of Patients With a Live Birth|A live birth cycle was defined as a cycle with a delivery after 20 weeks of gestation.|>20 weeks gestation|The live birth rates in the study trial groups|||Participants|||Count of Participants
2538709|NCT03095027|Primary|Visual Acuity (VA)|VA was assessed and collected using a Snellen chart. Conversion to logMAR (logarithm of the minimum angle of resolution) was performed. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. Both eyes contributed to the analysis.|Baseline/Dispense (Day 1), Week 1, each product|Full Analysis Set|||logMAR|Eyes|Standard Deviation|Mean
2538710|NCT03094806|Secondary|In Hospital Mortality|Death at the time of discharge|Up to 2 weeks||||Participants|||Count of Participants
2538711|NCT03094806|Secondary|Difference in Bedside Spirometry|Degree of airflow obstruction (FEV1/FVC)|Day 5||||ratio||Standard Deviation|Mean
2538712|NCT03094806|Secondary|Change in 6MWT Test|A six-minute walk test (6MWT) measures the distance that an individual can walk on a flat, hard surface in a period of six minutes. This is used to assess the exercise tolerance measured by the difference in meters between the tests.|Day 1 and Day 5||||meters||Standard Deviation|Mean
2538713|NCT03094806|Secondary|Dyspnea on the MMRC Scale|The Modified Medical Research Council (MMRC) dyspnea scale is used to assess an individual's shortness of breath. It starts at 0 where the shortness of breath occurs during strenuous exercise and progresses through to number 4 where the shortness of breath is maximal.|Up to 5 days||||score on a scale||Standard Deviation|Mean
2538714|NCT03094806|Secondary|Dyspnea on the Borg Scale|Scale is used to rate the difficulty of breathing. It starts at 0 where the breathing is causing no difficulty at all and progresses through to number 10 where the breathing difficulty is maximal.|Up to 5 days||||score on a scale||Standard Deviation|Mean
2538720|NCT03093350|Primary|The Proportion of Evaluable Patients With Complete Response or Partial Response or Stable Disease for ≥10 Weeks From the First Infusion (6 Weeks After the Second Infusion) According to the RECIST Criteria|To determine the clinical efficacy associated with the administration of multiTAA-specific T cells in breast cancer patients with metastatic or locally recurrent unresectable disease as measured by clinical benefit rate (defined as overall response plus stable disease for 10 weeks or longer) according to the RECIST criteria.|12 weeks|12 patients were enrolled, but 10 were assigned to treatment. 1 patient signed consent but never began treatment, and 1 patient died before treatment began. 9 patients completed treatment; 1 patient progressed prior to 2nd infusion and was considered inevaluable.|||Participants|||Count of Participants
2538721|NCT03093272|Secondary|Overall Survival|Overall Survival (OS) is defined as the time from trial treatment start to death due to any cause, or censored at date last known alive.|Measured from end of study treatment to death due to any cause; OS measured as 22.4 months||||months|||Number
2538722|NCT03093272|Secondary|Serum PSA Change From Baseline to 12 Weeks on Treatment|The maximum percent PSA change (rise or fall) from baseline to after 12 weeks on study. For patients who discontinue on or before the 12 week assessment or for whom the 12 week assessment is missing, the last observation prior to the week 12 assessment will be utilized. Patients with no post-baseline PSA data will be excluded from the summary.|PSA was measured on Cycle 1 Day 1 (Baseline) and at 12 weeks on treatment.||||percent||Inter-Quartile Range|Median
2538723|NCT03093272|Secondary|Area Under the Curve (AUC) for Docetaxel Pharmacokinetic Analysis|The area under the blood concentration-time curve (linear trapezoidal rule) will be determined between 0-24 hours (AUC0-24). The PK samples were collected during the first two days of cycles 1 and 2.|Cycle 1, 2: During infusion at pre-dose, 15 minutes and 30 minutes post-dose, end of dose, and 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post dose.|Pharmacokinetic samples were not collected or received for 3 patients during C2D1.|||ng•h/mL||Standard Deviation|Mean
2538724|NCT03093272|Secondary|Maximum Blood Concentration (Cmax) for Docetaxel Pharmacokinetic Analysis|The pharmacokinetic (PK) parameters of the first 9 patients enrolled at Dana-Farber Cancer Institute will be determined using noncompartmental methods with WinNonLin version 5.2. Maximum blood concentration (Cmax) will be determined by visual inspection. Due to the premature termination of the study, only 9 patients were evaluated. The PK samples were collected on Days 1 and 2 of the first two treatment cycles.|Cycle 1, 2: During infusion at pre-dose, 15 minutes and 30 minutes post-dose, end of dose, and 0.5, 1, 1.5, 2, 4, 6, 8, 24 hours post dose.|Pharmacokinetic samples were not collected or received for 3 patients during C2D1.|||ng/mL||Standard Deviation|Mean
2538725|NCT03093272|Secondary|Number of Participants With Dose-Limiting Toxicities in the Safety Lead-in Group (First 6 Patients)|Specific adverse events will be recorded during the safety lead-in phase of 6 patients. Any toxicities considered unacceptable during this time will be considered a dose-limiting toxicity and will be summarized among all patients evaluable for a dose-limiting toxicity (DLT).|First 3 weeks of treatment|If the first 3 patients were accrued had no DLTs, then an additional 3 patients were accrued to observe for DLTs. If less than 2 patients experienced a DLT, the study opened to full accrual.|||Participants|||Count of Participants
2538726|NCT03093272|Primary|To Evaluate Progression-free Survival on the Combination of Docetaxel Plus Apalutamide|"Progression free survival (PFS) is defined as the time from treatment initiation until the occurrence of one of the following:~A participant was considered to have progressed by bone scan if~the first bone scan with greater than or equal to (≥) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from study drug initiation and was confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline);~the first bone scan with ≥2 new lesions compared to baseline was observed in ≥12 weeks from study drug initiation and the new lesions were verified on the next bone scan ≥6 weeks later (a total of ≥2 new lesions compared to baseline);~Progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) by RECIST v. 1.1; or~Death from any cause."|Disease was evaluated radiologically at baseline and every 12 weeks on treatment; PFS follow up was up to 9.4 months|Three patients did not have the progression defined by protocol (patients 1, 2, and 8). Two patients (patients 2 and 8) did not have follow-up scans, and thus PFS was censored at the date of the registration. One patient (patient 1) progressed via rising PSA, not radiographically.|||months|||Number
2538727|NCT03093181|Secondary|Change From Baseline in Sebum Excretion Rate at Week 1, 4 and 8|The forehead of each participant was thoroughly cleansed by the investigator or designee using cotton pads saturated with 70% Isopropyl Alcohol and, after 5 minutes, the central area of the forehead above the eyebrows was measured in triplicate with a Sebumeter. The same area was measured in triplicate 90 minutes after cleansing. The sebum excretion rate was calculated by the difference in 90th minutes and 5th minute Sebumeter values.|At Baseline, Week 1, 4 and 8|ITT (N= 132) population included all participants who were randomized into the study and have at least one post-baseline measurement available.|||μg/cm^2||Standard Deviation|Mean
2538728|NCT03093181|Secondary|Change From Baseline in Sebumeter Values at Week 1, 4 and 8|A treatment blinded, trained and qualified evaluator conducted instrumental measurements of skin sebum levels. Measurement of skin sebum levels was performed by with a Sebumeter SM 815. The measurement principle of the SM 815 is based on grease spot photometry. The translucent tape of the device is brought into contact with skin and becomes increasingly transparent in response to surface oil. The tape is inserted into the aperture of the device and its transparency measured by light transmission, with increased transmission signifying increased oiliness. The software outputs mass sebum levels as a function of area. Sebumeter measurements were taken in triplicate at the central forehead (above the eyebrows) with the participant lying horizontally, on their back.|At Baseline, Week 1, 4 and 8|ITT (N= 132) population included all participants who were randomized into the study and have at least one post-baseline measurement available.|||Micrograms (μg)/square centimeter (cm^2)||Standard Deviation|Mean
2538729|NCT03093181|Secondary|Change From Baseline in Evaluator's Assessment of Total Blemish Count at Week 1, 4, and 8|A treatment blind, trained and qualified evaluator counted the total number of facial blemishes on the forehead, cheeks and chin of the participants.|At Baseline, Week 1, 4 and 8|ITT (N= 132) population included all participants who were randomized into the study and have at least one post-baseline measurement available.|||Total Blemish Count||Standard Deviation|Mean
2538730|NCT03093181|Secondary|ANOVA Analysis on Improvement Rating of Lay Person Assessment of Polarized and Non-polarized Images Week 8 Compared to Baseline|Baseline and Week 8 photographs of all participants were displayed side by side on high resolution, color-calibrated display screen in room with neutral wall colors and standardized lighting with minimized glare. Relative positioning (left and right) of baseline and Week 8 photographs were blinded to evaluator and randomized. Lay evaluators ranked magnitude of improvement in overall appearance of blemishes using below criteria: Left=blemishes on left are more obvious than those on right; Right=blemishes on right are more obvious than those on left. Lay evaluator ranking for each image pair was converted into a numerical score based on whether Baseline or Week 8 image was ranked better:0=Baseline image was better than Week 8 image,1=Week 8 image was better than Baseline image. Minimum score 0 corresponded to all baseline images being better than Week 8 images. Maximum score 1 corresponded to all Week 8 images being better than baseline images. Higher scores indicated better results.|At Baseline and Week 8|ITT (N= 132) population included all participants who were randomized into the study and have at least one post-baseline measurement available.|||Score on scale||Standard Error|Least Squares Mean
2538731|NCT03093181|Secondary|Odds for Logistic Regression Analysis on Improvement Rating of Lay Person Assessment of Polarized and Non-polarized Images Week 8 Compared to Baseline|The baseline and week 8 photographs of all participants were displayed side by side on high resolution, color-calibrated display screen in room with neutral wall colors and standardized lighting and all practical efforts were made to minimize glare. The relative positioning (left and right) of baseline and week 8 photographs were blinded to evaluator and randomized. A technician used randomization schedule to display pair of images to lay evaluator. Lay evaluators judged magnitude of improvement in overall appearance of blemishes using the below criteria: Left=blemishes on left are more obvious than those on the right and Right=blemishes on right are more obvious than those on the left. Layperson ranked both left and right image as follows:1=Better;2=Worse. Odds was calculated from logistic regression including treatment and age stratum effects and exchangeable correlation. Odds=p/(1−p) where p was the probability of event that Week 8 was better than baseline.|At Baseline and Week 8|ITT (N= 132) population included all participants who were randomized into the study and have at least one post-baseline measurement available.|||Odds|||Number
2538732|NCT03093181|Secondary|Change From Baseline in Corneometer Values at 1 and 3 Hours on Day 1 and at Week 1, 4 and 8|A blinded, trained and qualified evaluator conducted instrumental measurements of skin moisturisation. Measurement of skin moisturisation was performed by the electrical capacitance method with a Corneometer CM 865. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content. Higher Corneometer values are indicative of improved skin moisturisation.|At Baseline, Day 1, Week 1, 4 and 8|ITT (N= 132) population included all participants who were randomized into the study and have at least one post-baseline measurement available.|||Arbitrary Corneometer unit||Standard Deviation|Mean
2538733|NCT03093181|Primary|Change From Baseline in Corneometer Values at 8 Hours on Day 1|A blinded, trained and qualified evaluator conducted instrumental measurements of skin moisturization.Measurement of skin moisturization was performed by the electrical capacitance method with a Corneometer CM 865. The measuring principle was based on changes in the capacitance of the measuring head, functioning as a condensator. Between the conductors of the probe an electrical field was built which allows the dielectricity of the stratum corneum to be measured. Because the dielectricity of the skin varies as a function of its water content.The range of hydration level was 0 (as dry as possible)~120 AU (Arbitrary Unit)(most moist possible).Higher Corneometer values are indicative of improved skin moisturization.|At Baseline and Day 1|Intent to treat (ITT, N= 132) population included all participants who were randomized into the study and have at least one post-baseline measurement available.|||Arbitrary Corneometer unit||Standard Deviation|Mean
2538734|NCT03093025|Secondary|Clinical Global Impression-Improvement (CGI-I)|"Percentage of CGI-I improvers (Very much improved or Much improved) at Week 6"|6 weeks||||percentage of participants|||Number
2538735|NCT03093025|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)|Percentage of MADRS responders (≥ 50% reduction in total score) at Week 6|6 weeks||||percentage of participants|||Number
2538736|NCT03093025|Secondary|Clinical Global Impression-Severity (CGI-S)|The CGI-S is a clinician-rated scale to assess the severity of the disorder. The time frame for this scale is the past 7 days. The score ranges from 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients).|6 weeks|Participants who did not receive at least one dose of investigational product or did not have at least one post-dose assessments were not included in the analysis.|||score on a scale||95% Confidence Interval|Least Squares Mean
2538737|NCT03093025|Secondary|Symptoms of Depression Questionnaire (SDQ)|The SDQ is a self-rated scale to assess the severity of symptoms across several subtypes of depression which consists from 44 items. The time frame for this scale is the past 7 days. Each item is scored on 6-point scale (1 [better than normal] to 6 [severe]). The total score is the sum of 44 items and can take range from 44 to 264. A negative change from baseline indicates improvement.|6 weeks|Participants who did not receive at least one dose of investigational product or did not have at least one post-dose assessments were not included in the analysis.|||score on a scale||95% Confidence Interval|Least Squares Mean
2538738|NCT03093025|Secondary|Hamilton Anxiety Scale (HAM-A)|The HAM-A is a clinician-rated scale to assess anxiety symptoms which consists from 14 items. The time frame for this scale is the past 7 days. Each item is scored on 5-point scale (0 [absence of symptoms] to 4 [severe]). The total score is the sum of 14 items and can take range from 0 to 56. A negative change from baseline indicates improvement.|6 weeks|Participants who did not receive at least one dose of investigational product or did not have at least one post-dose assessments were not included in the analysis.|||score on a scale||95% Confidence Interval|Least Squares Mean
2538739|NCT03093025|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS is a clinician-rated scale to assess depressive symptoms which consists from 10 items. The time frame for this scale is the past 7 days. Each item is scored on 7-point scale (0 [absence of symptoms] to 6 [severe]). The total score is the sum of 10 items and can take range from 0 to 60. A negative change from baseline indicates improvement.|6 weeks|Participants who did not receive at least one dose of investigational product or did not have at least one post-dose assessments were not included in the analysis.|||score on a scale||95% Confidence Interval|Least Squares Mean
2538741|NCT03092791|Secondary|Geometric Mean Titers (GMT) on Days 85, 365 and 393 in Infant Dose Ranging Cohort|GMT titers for poliovirus types 1, 2, and 3 for both Sabin and Salk strains will be reported.|Days 85, 365 and 393|PPS in 'Infant Dose Ranging Cohort': participants in FAS who had no major protocol violations. FAS: participants who were randomized and received at least one dose of trial vaccines. Number analyzed is number of participants with data available for analysis at given timepoint. Study was early terminated, data for Days 365 and 393 are not reported.|||titer||95% Confidence Interval|Geometric Mean
2538742|NCT03092791|Secondary|Seropositivity/Seroprotection Rate (SPR) on Days 85, 365 and 393 in Infant Dose Ranging Cohort|SPR is defined as the percentage of participants with antibodies titers of poliovirus types 1, 2, and 3 for both Sabin and Salk strain ≥8.|Days 85, 365 and 393|Per-protocol set (PPS) included all participants in the full analysis set (FAS) who had no major protocol violations. The FAS included all participants who were randomized and received at least one dose of the trial vaccines. Study was early terminated, thus data for Days 365 and 393 are not reported.|||percentage of participants||95% Confidence Interval|Number
2538743|NCT03092791|Secondary|Number of Participants Experiencing SAEs Throughout the Entire Trial Duration in Adult Lead-in Cohort|An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.|Day 1 up to Day 8|Safety Set in 'Adult Lead-in Cohort' included all participants who received at least one dose of the trial vaccines.|||Participants|||Count of Participants
2538744|NCT03092791|Secondary|Number of Participants Experiencing Non-serious Unsolicited AEs Within the 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort|An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events [SAEs]) that occurred other than those that are solicited.|Within 7 days of sIPV or placebo vaccination|Safety Set in 'Adult Lead-in Cohort' included all participants who received at least one dose of the trial vaccines.|||Participants|||Count of Participants
2538745|NCT03092791|Secondary|Number of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort|A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each immunization. Data is only reported for those categories with at least 1 participant.|Within 7 days of sIPV or placebo vaccination dose given on Day 1|Safety Set in 'Adult Lead-in Cohort' included all participants who received at least one dose of the trial vaccines.|||Participants|||Count of Participants
2538746|NCT03092791|Secondary|Number of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort|Solicited systemic AEs were collected by participants within 7 days after vaccination and included headache, asthenia, malaise, arthralgia and myalgia and fever. Severity scales for headache were none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents normal activity with or without treatment. Severity scales for others were none, mild: no interference with daily activity, moderate: interference with daily activity and severe: prevents daily activity. Data is only reported for those categories with at least 1 participant.|Within 7 days of sIPV or placebo vaccination|Safety Set in 'Adult Lead-in Cohort' included all participants who received at least one dose of the trial vaccines.|||Participants|||Count of Participants
2538747|NCT03092791|Secondary|Number of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After a Single Dose of sIPV or Placebo in Adult Lead-in Cohort|Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: <25 mm, mild: >25 - ≤ 50 mm, moderate: > 50 - ≤ 100 mm, severe: > 100 mm).|Within 7 days of sIPV or placebo vaccination|Safety Set in 'Adult Lead-in Cohort' included all participants who received at least one dose of the trial vaccines. Only categories for which there was at least 1 participant are reported.|||Participants|||Count of Participants
2538748|NCT03092791|Secondary|Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in Toddler Lead-in Cohort|An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.|Day 1 up to Day 183|Safety Set in 'Toddlers Lead-in Cohort' included all participants who received at least one dose of the trial vaccines.|||percentage of participants|||Number
2538749|NCT03092791|Secondary|Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort|An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events [SAEs]) that occurred other than those that are solicited.|Within 28 Days of booster vaccination given on Day 365|Study was terminated early, therefore data were not collected.||||||
2538750|NCT03092791|Secondary|Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort|Fever is defined as greater than or equal to 38°C (100.4°F) regardless of method used.|Within 7 days of booster vaccination given on Day 365|Study was terminated early, therefore data were not collected.||||||
2538751|NCT03092791|Secondary|Percentage of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort|Percentage of participants with solicited systemic adverse events on a symptom by symptom basis, in each severity category will be reported. Solicited systemic adverse events include headache, asthenia, malaise, arthralgia, myalgia.|Within 7 days of booster vaccination given on Day 365|Study was terminated early, therefore data were not collected.||||||
2538752|NCT03092791|Secondary|Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Toddler Lead-in Cohort|Percentage of participants with solicited local reactions on a symptom by symptom basis, in each severity category will be reported. Solicited local reactions include pain, erythema, induration and swelling.|Within 7 days of booster vaccination given on Day 365|Study was terminated early, therefore data were not collected.||||||
2538753|NCT03092791|Secondary|Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than SAEs) that occurred other than those that are solicited.|Within 28 days of booster vaccination given on Day 365|Study was terminated early, therefore data were not collected.||||||
2538754|NCT03092791|Secondary|Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort|Fever is defined as greater than or equal to 38°C (100.4°F) regardless of method used.|Within 7 days of booster vaccination given on Day 365|Study was terminated early, therefore data were not collected.||||||
2538755|NCT03092791|Secondary|Percentage of Participants With Solicited Systemic AEs Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort|Percentage of participants with solicited systemic adverse events on a symptom by symptom basis, in each severity category will be reported. Solicited systemic adverse events include drowsiness, irritability/fussiness, loss of appetite, and fever. Fever is defined as greater than or equal to 38°C (100.4°F) regardless of method used.|Within 7 days of booster vaccination given on Day 365|Study was terminated early, therefore data were not collected.||||||
2538756|NCT03092791|Secondary|Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Booster Vaccination in Infant Dose Ranging Cohort|Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (0-none, 1-mild: Minor reaction to touch, 2-moderate: Cries/protests on touch, 3-severe: Cries when limb is moved/spontaneously painful), erythema, induration and swelling (0: <10 mm, 1-Mild: >10 - ≤ 20 mm, 2-Moderate: > 20 - ≤ 40 mm, 3-Severe: > 40 mm).|Within 7 days of booster vaccination given on Day 365|Study was terminated early, therefore data were not collected.||||||
2538757|NCT03092791|Secondary|Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV or IPV Study Arms in Infant Dose Ranging Cohort|An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.|Day 1 up to Day 547|Safety Set in 'Infant Dose Ranging Cohort' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||percentage of participants|||Number
2538758|NCT03092791|Secondary|Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort|An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events [SAEs]) that occurred other than those that are solicited.|Within 28 Days of primary vaccinations (Up to 85 days)|Safety Set in 'Infant Dose Ranging Cohort' included all participants who received at least one dose of the trial vaccines.|||percentage of participants|||Number
2538759|NCT03092791|Secondary|Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV in Infant Dose Ranging Cohort|A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant.|Within 7 days of primary vaccinations (First Dose given on Day 1, Second Dose given on Day 29, Third Dose given on Day 57)|Safety Set in 'Infant Dose Ranging Cohort' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||percentage of participants|||Number
2538760|NCT03092791|Secondary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort|Solicited systemic AEs were collected within 7 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. Data is only reported for those categories with at least 1 participant.|Within 7 days of primary vaccinations (First Dose given on Day 1, Second Dose given on Day 29, Third Dose given on Day 57)|Safety Set in 'Infant Dose Ranging Cohort' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||percentage of participants|||Number
2538777|NCT03092752|Primary|Prescription Rate of Each Class in Each eGFR Renal Impairment (RI) Level|Renal impairment (RI) is a common complication in patients with type 2 diabetes mellitus (T2DM). Results observed were based on index dates used for comparing drugs between the classes.|Within 6 months from index date|All index dates computed from patients with eGFR data included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.|||Participants|||Number
2538761|NCT03092791|Secondary|Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV or IPV by Severity in Infant Dose Ranging Cohort|Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (0-none, 1-mild: Minor reaction to touch, 2-moderate: Cries/protests on touch, 3-severe: Cries when limb is moved/spontaneously painful), erythema, induration and swelling (0: <10 mm, 1-Mild: >10 - ≤ 20 mm, 2-Moderate: > 20 - ≤ 40 mm, 3-Severe: > 40 mm). Data is only reported for those categories with at least 1 participant.|Within 7 days of primary vaccinations (First Dose given on Day 1, Second Dose given on Day 29, Third Dose given on Day 57)|Safety Set in 'Infant Dose Ranging Cohort' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||percentage of participants|||Number
2538762|NCT03092791|Primary|Percentage of Participants With Seroconversion|Seroconversion is defined as i) initially seronegative infants (titer <8 at Day 1) having a titer ≥8 at Day 85, or ii) initially seropositive infants (titer ≥8 at Day 1) with a 4-fold rise in antibody titers over the expected level of maternal antibodies at Day 85, calculated using a decline from the Day 1 titer with a half-life of 28 days.|Day 85|Per-protocol set (PPS) in 'Infant Dose Ranging Cohort' included all participants in full analysis set (FAS) who had no major protocol violations. FAS included all participants who were randomized and received at least one dose of trial vaccines. Number analyzed is number of participants with data available for analysis at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2538763|NCT03092791|Primary|Percentage of Participants Experiencing SAEs Throughout the Entire Trial Duration in the sIPV Study Arms in Infant Dose Ranging Cohort|An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.|Day 1 up to Day 547|Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||percentage of participants|||Number
2538764|NCT03092791|Primary|Percentage of Participants Experiencing Non-serious Unsolicited AEs Within the 28-day Period (Including Day of Vaccination) After Each Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort|An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. Non-serious unsolicited AEs indicates any and all AEs (other than serious adverse events [SAEs]) that occurred other than those that are solicited.|Within 28 days of primary vaccinations given on Days 1, 29 and 57 (Up to Day 85)|Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines.|||percentage of participants|||Number
2538765|NCT03092791|Primary|Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV on Day 57|A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant.|Within 7 days of the Third Dose given on Day 57|Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||percentage of participants|||Number
2538766|NCT03092791|Primary|Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV on Day 29|A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant.|Within 7 days of the Second Dose given on Day 29|Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||percentage of participants|||Number
2538767|NCT03092791|Primary|Percentage of Participants With a Body Temperature ≥ 38°C (Defined as Fever) During the 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV on Day 1|A systemic adverse event (AE) of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 7 days after each Immunization. Data is only reported for those categories with at least 1 participant.|Within 7 days of the First Dose given on Day 1|Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||percentage of participants|||Number
2538768|NCT03092791|Primary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57|Solicited systemic AEs were collected within 7 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. Data is only reported for those categories with at least 1 participant.|Within 7 Days of the Third Dose given on Day 57|Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||percentage of participants|||Number
2538857|NCT03090958|Secondary|System Usability Scale Scores|Acceptability of AllyQuest will be measured by the System Usability Scale (SUS). An 11-item, 7-point Likert scale of subjective assessments of usability (1=strongly agree; 7=strongly disagree). The SUS is technology independent and provides a global measure of system satisfaction and sub-scales of usability and learnability.|4 weeks||||Scores on a scale||Standard Deviation|Mean
2538769|NCT03092791|Primary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29|Solicited systemic AEs were collected within 7 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. Data is only reported for those categories with at least 1 participant.|Within 7 days of the Second Dose given on Day 29|Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||percentage of participants|||Number
2538770|NCT03092791|Primary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1|Solicited systemic AEs were collected within 7 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. Data is only reported for those categories with at least 1 participant.|Within 7 days of the First Dose given on Day 1|Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||percentage of participants|||Number
2538771|NCT03092791|Primary|Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Third Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 57|Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: <25 mm, mild: >25 - ≤ 50 mm, moderate: > 50 - ≤ 100 mm, severe: > 100 mm). Data is only reported for those categories with at least 1 participant.|Within 7 Days of the Third Dose given on Day 57|Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||percentage of participants|||Number
2538772|NCT03092791|Primary|Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After Second Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 29|Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: <25 mm, mild: >25 - ≤ 50 mm, moderate: > 50 - ≤ 100 mm, severe: > 100 mm). Data is only reported for those categories with at least 1 participant.|Within 7 days of the Second Dose given on Day 29|Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||percentage of participants|||Number
2538773|NCT03092791|Primary|Percentage of Participants With Solicited Local Reactions Within 7-day Period (Including Day of Vaccination) After First Primary Immunization Dose of sIPV in Infant Dose Ranging Cohort by Severity on Day 1|Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment, severe: prevents daily activity with or without treatment), erythema, induration and swelling (any: <25 mm, mild: >25 - ≤ 50 mm, moderate: > 50 - ≤ 100 mm, severe: > 100 mm). Data is only reported for those categories with at least 1 participant.|Within 7 days of the First Dose given on Day 1|Safety Set in 'Infant Dose Ranging Cohort - sIPV arms' included all participants who received at least one dose of the trial vaccines. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||percentage of participants|||Number
2538774|NCT03092752|Primary|Percentage of Comorbidities by OAD Classes.|The additional diseases co-occuring, defined by International classification of Diseases, tenth revision (ICD-10) code. Results observed were based on index dates used for comparing drugs between the classes.|On the index month|All index dates computed from patients included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.|||Percentage of Comorbidities|||Number
2538775|NCT03092752|Primary|Percentage of Previous Medications (Premedications) by OAD Classes.|Previous medication is the drug prescribed other than drug under study in the OAD class before index date. Results observed were based on index dates used for comparing drugs between the classes|On the index month|All index dates computed from patients included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.|||Percentage of Prescriptions|||Number
2538776|NCT03092752|Primary|Percentage of Concomitant Medications by OAD Classes|Concomitant medication is the drug prescribed other than drug under study in the OAD class on index date. Results observed were based on index dates used for comparing drugs between the classes.|On the index month|All index dates computed from patients included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.|||Percentage of Prescriptions|||Number
2538778|NCT03092752|Primary|Estimated Glomerular Filtration Rate (eGFR)|Estimated glomerular filtration rate (eGFR) was calculated based on the age at index date and the latest serum creatinine at index date (or during the observation period) using formula eGFR millilitre/minute/1.73 meter^2 (mL/min/1.73 m^2) = 194 × (Creatinine)^-1.094 × (age in year)^-0.287 (× 0.739 if female). Analysis was done based on index dates used for comparing drugs between the classes.|Within 6 months from index date|All index dates computed from patients with eGFR data included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.|||millilitre/minute/1.73 meter^2||Standard Deviation|Mean
2538779|NCT03092752|Primary|Sex (Male/Female)|Gender of all patients observed for index dates computed from patients in the database. Results observed were based on index dates used for comparing drugs between the classes. The reported data represent the number of time a prescription was written between 1st January 2014 and 30th September 2016.|From 1st January 2014 to 30th September 2016 (At index date)|All index dates computed from patients included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.|||Participants|||Number
2538780|NCT03092752|Primary|Age (Years)|Age of all patients in years calculated for index dates computed from patients in the database. Analysis was done based on index dates used for comparing drugs between the classes. The reported data represent the number of time a prescription was written between 1st January 2014 and 30th September 2016.|From 1st January 2014 to 30th September 2016 (At index date)|All index dates computed from patients included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.|||Years||Standard Deviation|Mean
2538781|NCT03092752|Primary|Number of Index Dates|The date at which patients having their first prescription for any study drugs between 1st January 2014 and 30th September 2016 is defined as index date. Results observed were based on index dates used for comparing drugs between the classes. The reported data represent the number of time a prescription was written between 1st January 2014 and 30th September 2016.|From 1st January 2014 to 30th September 2016 (At index date)|All index dates computed from patients included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.|||Number of Prescriptions|||Number
2538782|NCT03092752|Secondary|Number of Prescriptions of OAD by Each Renal Impairment (RI) Stages|This outcome observes number of index dates for each class of OAD as per RI classes. RI classes were defined based on eGFR values. Results observed were based on index dates used for comparing drugs between the classes.|Within 6 months from index date|All index dates computed from patients with eGFR data, included in the study were considered for this analysis. Some patients were prescribed for more than one study drug and thus we can observe more number of index dates than number of patients.|||Prescriptions|||Number
2538783|NCT03092726|Secondary|Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)|"The PGIC is a self-administered 7-point Likert scale that asks participants to evaluate their fibromyalgia relative to baseline. This is a single question and the grade ranges from 1 (Very Much Improved) to 7 (Very Much Worse)."|Weeks 2, 4, 8|"The analysis population was the FAS. Modified LOCF (mLOCF) was used for weeks 2, 4, and 8, where No Change was imputed for participants who discontinued due to lack of efficacy or AEs, and LOCF was used for participants who discontinued due to other reasons. LOCF was used for EOT."|||Participants|||Count of Participants
2538784|NCT03092726|Secondary|Change From Baseline to Weeks 2, 4, 8, and EOT in the FIQR Overall Impact Subscale Score|The FIQR was developed to capture the total spectrum of problems related to fibromyalgia and the responses to therapy. The 21-item FIQR contains 3 subscales: function (9 questions), overall impact (2 questions), and symptoms (10 questions). Participants answer each question on an 11-point NRS, with anchors appropriate to each question on a tablet device during a visit. The recall period was the last 7 days. The Overall Impact subscale has a range of scores from 0 to 20, with a lower score indicating better (lower) impact. A negative change indicated a reduction/improvement from baseline (i.e., a favorable outcome).|Baseline and weeks 2, 4, 8|The analysis population was the FAS. Participants with available data at baseline were included in the analysis. LOCF was used for EOT.|||Units on a scale||Standard Error|Least Squares Mean
2538785|NCT03092726|Secondary|Change From Baseline to Weeks 2, 4, 8, and EOT in the FIQR Symptoms Subscale Score|The FIQR was developed to capture the total spectrum of problems related to fibromyalgia and the responses to therapy. The 21-item FIQR contains 3 subscales: function (9 questions), overall impact (2 questions), and symptoms (10 questions). Participants answer each question on an 11-point NRS, with anchors appropriate to each question on a tablet device during a visit. The recall period was the last 7 days. The Symptoms subscale range of scores is 0 to 100, with a lower score indicating a better (lower) level of symptoms. A negative change indicates a reduction/improvement from baseline (i.e., a favorable outcome).|Baseline and weeks 2, 4, 8|The analysis population was the FAS. Participants with available data at baseline were included in the analysis. LOCF was used for EOT.|||Units on a scale||Standard Error|Least Squares Mean
2538786|NCT03092726|Secondary|Change From Baseline to Weeks 2, 4, 8 and EOT in the Fibromyalgia Impact Questionnaire Revised (FIQR) Function Subscale Score|The FIQR was developed to capture total spectrum of problems related to fibromyalgia and the responses to therapy. The 21-item FIQR contains 3 subscales: function (9 questions), overall impact (2 questions), and symptoms (10 questions). Participants answer each question on an 11-point NRS, with anchors appropriate to each question on a tablet device during a visit. The recall period was the last 7 days or the last time the activity was performed if not within the 7-day recall period. The Function subscale has a range of scores of 0 to 90, with a lower score indicating better (higher) function. A negative change indicated a reduction/improvement from baseline (i.e., a favorable outcome).|Baseline and weeks 2, 4, 8|The analysis population was the FAS. Participants with available data at baseline were included in the analysis. LOCF was used for EOT.|||Units on a scale||Standard Error|Least Squares Mean
2538808|NCT03091777|Primary|Clinical Cure|Resolution of clinical signs and symptoms|Day 21-30|Modified Intent-to-Treat (mITT) population: All randomized subjects who received study treatment and returned for at least one post-baseline visit, but excluding those who demonstrate a positive test result for other concomitant vaginal or cervical infections at baseline (e.g. C. trachomatis, N. gonorrhoeae) or who have a baseline Nugent score<4.|||Participants|||Count of Participants
2538787|NCT03092726|Secondary|Percentage of Participants With ≥ 50% Reduction From Baseline to Week 8 and EOT in Mean Daily Average Pain Score as Assessed by NRS|"The mean daily average pain score was assessed thorugh the Daily Average Pain NRS, which is a generic instrument for the assessment of pain that consists of a single question that asks participants to record their daily average pain on an 11-point scale, where 0 anchors no pain and 10 pain as bad as you can imagine. The mean daily average pain score was calculated from data recorded by participants daily in the electronic diary, and the recall period was the last 24 hours. For the week 8 analysis, participants with missing baseline or week 8 data were classified as nonresponders. For EOT analysis, participants with missing baseline or EOT data were classified as nonresponders."|Baseline to week 8|The analysis population was the FAS. BOCF was used for week 8. LOCF was used for EOT.|||Percentage of participants||90% Confidence Interval|Number
2538788|NCT03092726|Secondary|Percentage of Participants With ≥ 30% Reduction From Baseline to Week 8 and End of Treatment (EOT) in Mean Daily Average Pain Score as Assessed by NRS|"The mean daily average pain score was assessed through the Daily Average Pain NRS, which is a generic instrument for the assessment of pain that consists of a single question that asks participants to record their daily average pain on an 11-point scale, where 0 anchors no pain and 10 pain as bad as you can imagine. The mean daily average pain score was calculated from data recorded by participants daily in the electronic diary, and the recall period was the last 24 hours. For the week 8 analysis, participants with missing baseline or week 8 data were classified as nonresponders. For EOT analysis, participants with missing baseline or EOT data were classified as nonresponders."|Baseline to week 8|The analysis population was the FAS. Baseline Observation Carried Forward (BOCF) was used for week 8. Last Observation Carried Forward (LOCF) was used for EOT.|||Percentage of participants||90% Confidence Interval|Number
2538789|NCT03092726|Primary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behavior|The C-SSRS is a questionnaire used for suicide risk assessment. Affirmative or negative responses were provided to 5 items to suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide).|Weeks 1 to 8|The analysis population was the SAF. Participants with available data were included in the analysis.|||Participants|||Count of Participants
2538790|NCT03092726|Primary|Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation|The Columbia Suicide Severity Rating Scale (C-SSRS) is a questionnaire used for suicide risk assessment. Affirmative or negative responses were provided to 5 items to suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent).|Weeks 1 to 8|The analysis population was the SAF. Participants with available data were included in the analysis.|||Participants|||Count of Participants
2538791|NCT03092726|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|Safety was assessed by adverse events (AEs), which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A TEAE was defined as any AE that started or worsened after the first dose of study drug up to 30 days after the last dose of study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization. TEAEs in drug abuse, dependence and withdrawal standardized MedDRA query (SMQ) are special AEs of interest grouped together using the SMQ tool (MedDRA v20.0).|From first dose of study drug up to 30 days after last dose of study drug (up to 87 days)|The analysis population was the SAF.|||Participants|||Count of Participants
2538792|NCT03092726|Primary|Change From Baseline to Week 8 in Mean Daily Average Pain Score as Assessed by Numerical Rating Scale (NRS)|"The mean daily average pain score was assessed thorugh the Daily Average Pain NRS, which is a generic instrument for the assessment of pain that consists of a single question that asks participants to record their daily average pain on an 11-point scale, where 0 anchors no pain and 10 pain as bad as you can imagine. The mean daily average pain score was calculated from data recorded by participants daily in the electronic diary, and the recall period was the last 24 hours. A negative change indicated a reduction/improvement from baseline (i.e., a favorable outcome)."|Baseline and week 8|The analysis population was the full analysis set (FAS), which consisted of all randomized participants who took at least 1 dose of study drug. Participants with available data at baseline were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
2538793|NCT03092479|Secondary|Differences Between Groups in Loss of Eating Control.|The Loss of Control Over Eating Scale-Brief (LOCES) provides a 5 point scoring system to assess subject's loss of eating control. This scale will be used to assess differences in this measure between the Behavior Intervention and Control groups. Range is 5-35. Higher score indicates a worse outcome.|Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.||||score on a scale||Standard Deviation|Mean
2538794|NCT03092479|Secondary|Difference in Emotional Eating Scale Results Between Groups.|The Emotional Eating scale (EES) measures a subject's desire to eat in response to an emotional stimulus. This scale will be used to assess differences in emotional eating habits between the Behavior Intervention and Control groups. Subscale scores range 0-36 or 0-44. Higher scores indicates worse outcome.|Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.||||score on a scale||Standard Deviation|Mean
2538795|NCT03092479|Secondary|Difference in Physical Activity Levels Between Groups.|Differences in physical activity levels between the Behavior Intervention and Control groups will be measured by comparing hours per day spent in vigorous, moderate, light or sitting activity as recorded on the Paffenbarger Physical Activity Questionnaire (PPAQ). Calculated by minutes per week of Moderate to Vigorous Activity (MVPA).|Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.||||minutes (min)||Standard Deviation|Mean
2545821|NCT02937506|Primary|Patient Satisfaction|Satisfaction assessed using self-developed questionnaire.|Patient satisfaction was assessed the day of the procedure.|Same as enrolled.|||Participants|||Count of Participants
2538796|NCT03092479|Secondary|Difference Between Groups in Measured Self-efficacy.|Difference in self-efficacy parameters between the Behavior Intervention and Control groups will be measured by comparing responses generated from the Weight Efficacy Life-Style short-form scale (WEL-SF). Range is 0-80. Higher score indicates a better outcome|Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.||||score on a scale||Standard Deviation|Mean
2538797|NCT03092479|Secondary|Difference Between Groups in Anxiety Scores.|Difference in anxiety weighted scores between the Behavior Intervention and Control groups will be measured using the scores generated from the State-Trait Anxiety Inventory (STAI) and is scored on a four-point Likert scale. Range is 20-80 per subtest. Higher scores indicate a worse outcome.|Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.||||units on a scale||Standard Deviation|Mean
2538798|NCT03092479|Secondary|Difference Between Groups in Depression Scores.|Difference in depression scores between the Behavior Intervention and Control groups will be measured using the total score generated from the Patient Health Questionnaire (PHQ-9). Range is 0-27. Higher score means a worse outcome.|Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.||||score on a scale||Standard Deviation|Mean
2538799|NCT03092479|Primary|Difference in Mean Health-Related Quality of Life (HRQoL) Scores Related to Physical Function, Energy Level and General Health.|Health-Related Quality of Life emotional scale scores will be assessed by the SF-36-Item Short Form Health Survey between the Behavior Intervention and Control groups. This study seeks a difference of 2/3 standard deviation in scores between groups for statistical significance. Range 0-100. Higher score indicates a better outcome.|Surveys will be completed at baseline and at the completion of the 4 month session time period. Surveys will be provided to both study groups in parallel for consistency.||||score on a scale||Standard Deviation|Mean
2538800|NCT03092375|Secondary|Difference in SVR12 Rates for 12-wk vs 16 wk|Difference in proportions of SVR 12 rates will be determined for 12-week vs. 16-week treatment durations using contrasts within a logistic regression model with cirrhosis status and HCV genotype (1b vs non-1b) as factors|28 weeks|Modified Intent to Treat Population (mITT) analysis (All subjects enroll in Main study receiving at least one dose of study drug and according to the treatment arm in which they were actually treated)|||Participants|||Count of Participants
2538801|NCT03092375|Secondary|Difference in % of Relapse Between Cirrhotic Arms C & D|Difference in the percentage of compensated cirrhotic subjects with post-treatment relapse (defined as confirmed HCV RNA>=Lower limit of quantification (LLOQ) between end of treatment and 12 weeks after last dose of study drug among subjects who completed treatment as planned with HCV RNA<LLOQ at end of treatment) after receiving 12 weeks G/P +/-Ribavirin (RBV) (Arm C) versus 16 weeks G/P (Arm D)|Up to 28 weeks||||Participants|||Count of Participants
2538802|NCT03092375|Secondary|Difference in On-Treatment Virologic Failure Between Arms C and D in Cirrhotic Subjects|Difference in percentage of cirrhotic subjects experiencing on-treatment virologic failure (confirmed increase of > 1 log10 IU/mL above nadir during treatment, confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < 15 IU/mL during treatment, or HCV RNA ≥ LLOQ at the end of treatment with at least 6 weeks of treatment) after 12 weeks of G/P with or without RBV for 12 weeks versus 16 weeks of G/P|Up to 28 weeks|"Analysis was performed the study population as treated further defined as mITT-all subjects representing their actual study regimen and who received at least one dose of study drug."|||Participants|||Count of Participants
2538803|NCT03092375|Secondary|Difference in Relapse Between Arms A & B in Non-cirrhotic Subjects|Difference in Post-treatment relapse (defined as confirmed HCV RNA>= Lower limit of quantification (LLOQ) between end of treatment and 12 weeks after the last dose of study drug among subjects who completed treatment as planned with HCV RNA < LLOQ at end of treatment, excluding subjects with subjects with reinfection)|Up to 28 weeks|Analysis performed on any subject with study drug duration of 77 days or greater for Arm A or 105 days or greater for Arm B|||Participants|||Count of Participants
2538804|NCT03092375|Secondary|Difference in On-Treatment Virologic Failure Between Arms A & B (Non-cirrhotic Subjects)|Difference in % of subjects with on-treatment virologic failure further defined as either 1)Breakthrough a)Confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < Lower Limit of Quantification (LLOQ) at some point during the Treatment Period or confirmed increase from nadir in HCV RNA (two consecutive measurements > 1 log10 IU/mL above nadir) at any time point during the Treatment Period, or b) a single value indicating viral breakthrough (≥ 100 IU/mL or > 1 log10 above nadir), followed by patient status of 'Lost to Follow-up', the latter not requiring confirmation by a proximate measurement) or 2) End of Treatment Failure defined as HCV RNA ≥ LLOQ at end of treatment and following at least 6 weeks of treatment.|Up to 28 weeks|"Analysis was performed the study population as treated further defined as mITT-all subjects representing their actual study regimen and who received at least one dose of study drug."|||Participants|||Count of Participants
2538805|NCT03092375|Primary|Tolerability of G/P +/-RBV|Number of subjects who discontinued G/P due to adverse events|Up to 16 weeks||||Participants|||Count of Participants
2538806|NCT03092375|Primary|Comparison of Cirrhotic Participants Achieving SVR 12 After G/P Plus RBV for 12 Wks vs. G/P for 16 Wks|Number of cirrhotic participants who are treatment experienced with a NS5A inhibitor + SOF +/RBV with undetectable HCV RNA 12 weeks after completing G/P plus RBV for 12 wks vs. G/P for 16 Wks|Up to 28 weeks|Cirrhotic subjects achieving Virologic Response at Post-Treatment Week 12|||Participants|||Count of Participants
2538807|NCT03092375|Primary|SVR After G/P 12 Wks (Arm A) vs. G/P Given for 16 Weeks (Arm B) to Non-cirrhotic Treatment-experienced GT1 HCV Participants|Number of non-cirrhotic treatment-experienced HCV genotype 1 with a NS5Ai inhibitor + SOF +/-RBV participants with undetectable HCV RNA (HCV RNA <Lower Limit of Quantification -LLOQ) 12 weeks after completing G/P 300 mg/100 mg daily for 12 weeks (Arm A) vs. 16 weeks of G/P 300 mg/100 mg daily (Arm B)|Up to 28 weeks|These analyses were completed on Modified ITT -Genotype Population defined as all treated subjects representing their actual study regimen and who received at least one dose of study drug.|||Participants|||Count of Participants
2538858|NCT03090958|Primary|Average Days Participants Logged Medications.|Feasibility of AllyQuest will be based on usage as measured by the average number of days participants logged their medications in the app.|4 weeks|Missing data on 3 participants, hence only reporting data on 17 participants.|||Days||Standard Deviation|Mean
2538809|NCT03091751|Primary|Mean Difference of Mean Residence Time (MRT): BeneFIX Compared to AlphaNine|BeneFIX pharmacokinetic parameter of mean residence time (MRT 0-inf) was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 Study).|Baseline (prior to the infusion), and at 15 and 30 minutes, 1, 3, 6, 9, 24, 48, 72, and 74 hours following a single dose infusion of BeneFIX administered following a 7 to 15 day wash-out period.|Thirteen subjects with 2 prior pharmacokinetic assessments with AlphaNine (PK1, PK2) had a third PK assessment with BeneFIX (PK3). Nine subjects had PK3 analysis with BeneFIX as part of a previous study. In total, 22 subjects treated with BeneFIX (PK3) were analyzed jointly and compared to 25 subjects treated with AlphaNine (PK2).|||hours||Standard Deviation|Mean
2538810|NCT03091751|Primary|Mean Difference of Clearance: BeneFIX Compared to AlphaNine|BeneFIX pharmacokinetic parameter of clearance was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 Study).|Baseline (prior to the infusion), and at 15 and 30 minutes, 1, 3, 6, 9, 24, 48, 72, and 74 hours following a single dose infusion of BeneFIX administered following a 7 to 15 day wash-out period.|Thirteen subjects with 2 prior pharmacokinetic assessments with AlphaNine (PK1, PK2) had a third PK assessment with BeneFIX (PK3). Nine subjects had PK3 analysis with BeneFIX as part of a previous study. In total, 22 subjects treated with BeneFIX (PK3) were analyzed jointly and compared to 25 subjects treated with AlphaNine (PK2).|||mL/min x kg||Standard Deviation|Mean
2538811|NCT03091751|Primary|Mean Difference of Terminal Half-Life: BeneFIX Compared to AlphaNine|BeneFIX pharmacokinetic parameter of terminal half-life was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 Study).|Baseline (prior to the infusion), and at 15 and 30 minutes, 1, 3, 6, 9, 24, 48, 72, and 74 hours following a single dose infusion of BeneFIX administered following a 7 to 15 day wash-out period.|Thirteen subjects with 2 prior pharmacokinetic assessments with AlphaNine (PK1, PK2) had a third PK assessment with BeneFIX (PK3). Nine subjects had PK3 analysis with BeneFIX as part of a previous study. In total, 22 subjects treated with BeneFIX (PK3) were analyzed jointly and compared to 25 subjects treated with AlphaNine (PK2).|||hours||Standard Deviation|Mean
2538812|NCT03091751|Primary|Mean Difference of In Vivo Recovery: BeneFIX Compared to AlphaNine|BeneFIX pharmacokinetic parameter of in vivo recovery was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 Study).|Baseline (prior to the infusion), and at 15 and 30 minutes, 1, 3, 6, 9, 24, 48, 72, and 74 hours following a single dose infusion of BeneFIX administered following a 7 to 15 day wash-out period.|Thirteen subjects with 2 prior pharmacokinetic assessments with AlphaNine (PK1, PK2) had a third PK assessment with BeneFIX (PK3). Nine subjects had PK3 analysis with BeneFIX as part of a previous study. In total, 22 subjects treated with BeneFIX (PK3) were analyzed jointly and compared to 25 subjects treated with AlphaNine (PK2).|||kg/dL||Standard Deviation|Mean
2538813|NCT03091751|Primary|Mean Difference of Area Under the Curve (AUC): BeneFIX Compared to AlphaNine|BeneFIX pharmacokinetic parameter of area under the curve (AUC 0-inf) was assessed and compared to the AlphaNine pharmacokinetic parameter (PK2 study).|Baseline (prior to the infusion), and at 15 and 30 minutes, 1, 3, 6, 9, 24, 48, 72, and 74 hours following a single dose infusion of BeneFIX administered following a 7 to 15 day wash-out period.|Thirteen subjects with 2 prior pharmacokinetic assessments with AlphaNine (PK1, PK2) had a third PK assessment with BeneFIX (PK3). Nine subjects had PK3 analysis with BeneFIX as part of a previous study. In total, 22 subjects treated with BeneFIX (PK3) were analyzed jointly and compared to 25 subjects treated with AlphaNine (PK2).|||IU x hour/dL||Standard Deviation|Mean
2538814|NCT03091673|Secondary|Plasma Glucagon Tmax|Plasma glucagon time to maximum concentration for each age cohort will be analyzed descriptively.|0-180 minutes||||minutes||Standard Deviation|Mean
2538815|NCT03091673|Secondary|Plasma Glucagon Cmax|Plasma glucagon maximum concentration for each age cohort will be analyzed descriptively.|0-180 minutes||||mg/dL||Standard Deviation|Mean
2538816|NCT03091673|Secondary|Plasma Glucagon Area Under the Curve|Plasma glucagon area under the curve (AUC) for each age cohort will be analyzed descriptively.|0-90 minutes||||min*mg/dL||Standard Deviation|Mean
2538817|NCT03091673|Secondary|Time for Plasma Glucose to Increase by ≥25 mg/dL|Time for plasma glucose to increase by ≥25 mg/dL from baseline will be analyzed descriptively for each age cohort.|0-90 minutes||||minutes||Standard Deviation|Mean
2538818|NCT03091673|Primary|Change in Plasma Glucose|The primary endpoint for this study is an evaluation of change in plasma glucose following treatment with G-Pen, with an emphasis on the increase from baseline to 30 minutes post-dosing.|0-30 minutes|All enrolled subjects.|||mg/dL||Standard Deviation|Mean
2538819|NCT03091439|Secondary|Number of Participants With Clinical Response by Pathogen at Day 180 in the CE Population|Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring > 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency.|Day 180|There were no pathogens identified in this study; the participant enrolled had no pathogens detected on blood culture, and the optional bone biopsy was not performed.||||||
2538820|NCT03091439|Secondary|Number of Participants With Clinical Response by Pathogen at Day 42 in the CE Population|Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring > 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency.|Day 42|There were no pathogens identified in this study; the participant enrolled had no pathogens detected on blood culture, and the optional bone biopsy was not performed.||||||
2538821|NCT03091439|Secondary|Number of Participants With Clinical Response at Day 365 in the mITT and CE Populations|Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring > 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency.|Day 365|Due to early termination of the study prior to the Day 180 visit, the participant enrolled did not have data collected for the visits at Day 180 or Day 365, but did have an early termination visit prior to Day 180.||||||
2538822|NCT03091439|Secondary|Number of Participants With Clinical Response at Day 180 in the mITT and CE Populations|Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring > 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency.|Day 180|Due to early termination of the study prior to the Day 180 visit, the participant enrolled did not have data collected for this visit, but did have an early termination visit prior to Day 180.||||||
2538823|NCT03091439|Secondary|Number of Participants With Clinical Response at Day 42 in the Microbiological Modified Intent-to-Treat (Micro-mITT) Population|Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring > 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency.|Day 42|micro-mITT included participants in the mITT Population with a Gram-positive pathogen isolated from blood and/or bone specimen. No participants met criteria for the micro-mITT population.||||||
2538824|NCT03091439|Secondary|Number of Participants With Clinical Response at Day 42 in the mITT Population|Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring > 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency.|Day 42|mITT population included all randomized participants who received randomized medication and met the criteria for known or suspected Gram-positive osteomyelitis. Participants from whom only a Gram-negative pathogen was isolated from blood and/or bone culture were excluded. No participants were enrolled in the SOC arm.|||Participants|||Count of Participants
2538825|NCT03091439|Secondary|Number of Participants With Clinical Improvement at Day 28 in the CE Population|Clinical improvement was based on an assessment of pain and/or point tenderness compared to Baseline and assessment of inflammation as measured by C-reactive Protein (CRP). Clinical improvement was defined as no worsening of pain from Baseline, if present, and improvement in inflammation.|Baseline (Day 0) to Day 28|CE population included all participants in the mITT Population who received ≥ 1 dose of dalbavancin or ≥ 2 weeks of comparator and ≤ 1 dose of another (non-study) systemic antibiotic with activity against the causative organism for an indication other than osteomyelitis. No participants were enrolled in the SOC arm.|||Participants|||Count of Participants
2538826|NCT03091439|Secondary|Number of Participants With Clinical Improvement at Day 28 in the Modified Intent-to-Treat (mITT) Population|Clinical improvement was based on an assessment of pain and/or point tenderness compared to Baseline and assessment of inflammation as measured by C-reactive Protein (CRP). Clinical improvement was defined as no worsening of pain from Baseline, if present, and improvement in inflammation.|Baseline (Day 0) to Day 28|mITT population including all randomized participants who received randomized medication and met criteria for known or suspected Gram-positive osteomyelitis. Participants from whom only a Gram-negative pathogen was isolated from blood and/or bone culture were excluded. No participants were enrolled in the SOC arm.|||Participants|||Count of Participants
2538827|NCT03091439|Primary|Number of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population|Clinical response can be either cure, failure, or indeterminate. Cure was defined as recovery without need for additional antibiotic therapy. Failure was defined as the requirement of additional antibiotic therapy, new purulence, amputation due to progression of infection, requiring > 6 weeks of treatment in the SOC arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency. The number of participants in each response category is reported.|Day 42|CE population included all participants in the mITT Population who received ≥ 1 dose of dalbavancin or ≥ 2 weeks of comparator and ≤ 1 dose of another (non-study) systemic antibiotic with activity against the causative organism for an indication other than osteomyelitis. No participants were enrolled in the SOC arm.|||Participants|||Count of Participants
2538828|NCT03091400|Secondary|Change in Symbol Digit Modalities Test|Symbol Digit Modalities Test (Oral Version, total raw; possible range of 0-110): A test of processing speed requiring subjects to rapidly complete symbol-digit pairings based on a key. Incidental learning may contribute to performance. Total correct in 90 seconds is tallied. Results reported as follow-up minus baseline. Higher scores indicate better outcomes.|baseline and 14 weeks||||score on a scale||Standard Deviation|Mean
2538829|NCT03091400|Secondary|Change in Perceived Deficits Questionnaire (PDQ)|Perceived Deficits Questionnaire (PDQ): the PDQ asks subjects to rate twenty cognitive difficulties on a scale from never (0) to almost always (4). Total ranges from 0-80. Results reported as follow-up minus baseline. Higher scores indicate worse outcomes. If a change is detected, will proceed to identify which of the four subscales were affected: retrospective memory, prospective memory, attention, planning / organization.|baseline and 14 weeks||||score on a scale||Standard Deviation|Mean
2538830|NCT03091400|Secondary|Change in NIH Toolbox Picture Sequence Memory Test|NIH Toolbox Picture Sequence Memory Test (possible raw score range of 0-31): a tablet-based task requiring subjects to study the sequence of many activity scenes (e.g., flying a kite) presented visually and audibly. Correct sequences tallied. Results reported as follow-up minus baseline. Higher scores indicate better outcomes.|baseline and 14 weeks||||score on a scale||Standard Deviation|Mean
2538831|NCT03091400|Secondary|Change in CANTAB Paired Associate Learning|CANTAB Paired Associate Learning (Total Errors Adjusted; possible raw score range of 0-70): a tablet-based memory task requiring subjects to study and recall the location of complex visual images not easily verbalized. Errors are tallied. Results reported as follow-up minus baseline. Higher scores indicate worse outcomes.|baseline and 14 weeks||||score on a scale||Standard Deviation|Mean
2538832|NCT03091400|Secondary|Change in Patient-Reported Memory Change|Patients will endorse memory change over the past six weeks as: much improved (3), improved (2), slightly improved (1), unchanged (0), slightly worse (-1), worse (-2), much worse (-3).|baseline and 14 weeks||||score on a scale||Standard Deviation|Mean
2547122|NCT02912195|Secondary|Pain Score (NRS 0-10)|Pain score recorded on the numeric rating scale 0-10. 0 represents no pain and 10 represents the worst pain.|At 20 minutes||||units on a scale||95% Confidence Interval|Mean
2538833|NCT03091400|Primary|Change in Memory Change|Composite memory function (mean normative z-score) across verbal memory and visuospatial memory tasks: (1) Selective Reminding Test (SRT) assesses verbal learning of a 12-item word list over six trials (a. Total Learning; possible raw score range of 0-72), and recall after a delay (b: Delayed Recall; possible raw score range of 0-36); (2) Brief Visuospatial Memory Test, Revised (BVMT-R; possible raw score range of 0-36) assesses learning of six geometric shapes in six locations over three trials (c. Total Learning), and recall after a delay (d. Delayed Recall; possible raw score range of 0-12). Results reported as composite memory at follow-up minus baseline. Higher scores indicate better outcomes.|baseline and 14 weeks||||z-score||Standard Deviation|Mean
2538834|NCT03091361|Primary|Positive Predictive Value (PPV) of Localized Red Fluorescence Signals With Microbiological Samples|PPV reflects the probability that a region of red fluorescence within or around a wound will contain bacteria. Meaning the number cases where qPCR analysis of wound tissue biopsies from red fluorescent region showed to have pathogen load ≥ 104 CFU/g divided by the total number of cases where red florescence was observed in the wound multiplied by 100,|3 months||||percentage of PPV of red fluorescence|||Number
2538835|NCT03091348|Secondary|Change in International Prostate Symptom Scores|"Answers recorded at baseline, 2 weeks, up to 4 weeks.~Scale 0-35, from Mild to Severe Lower score is better"|after last vist #7|loss to follow up||||||
2538836|NCT03091348|Secondary|Change in Low Testosterone Questionnaire Responses|Answers recorded at baseline, 2 weeks, up to 4 weeks. Scale is 1-5 (strongly disagree to strongly agree) Lower scores are better|after last vist #7|loss to follow up||||||
2538837|NCT03091348|Secondary|Change in Levels of Whole Blood Hematocrit|Blood samples measured by Quest assays and equipment.|"Last visit (Visit 7)"|loss to follow up|||g/dL|||Number
2538838|NCT03091348|Secondary|Change in Level of Serum PSA|Blood samples measured by Beckman assays and equipment.|"Last visit (Visit 7)"|loss to follow up|||ng/mL|||Number
2538839|NCT03091348|Secondary|Change in Levels of Serum SHBG|Blood samples measured by Beckman assays and equipment.|"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"|loss to follow up|||nmol/l|||Number
2538840|NCT03091348|Secondary|Change in Levels of Serum FSH|Blood samples measured by Beckman assays and equipment.|"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"|loss to follow up|||miu/ml|||Number
2538841|NCT03091348|Secondary|Change in Levels of Serum LH|Blood samples measured by Beckman assays and equipment.|"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"|loss to follow up|||miu/ml|||Number
2538842|NCT03091348|Secondary|Change in Levels of Serum Estradiol|Blood samples measured by Beckman assays and equipment.|"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"|loss to follow up|||pg/mL|||Number
2538843|NCT03091348|Primary|Change in Levels of Serum Calculated Free T Concentration|Blood samples measured by Beckman assays and equipment.|"Last visit ( Visit 7)"|loss to follow up|||ng/dL|||Number
2538844|NCT03091348|Primary|Change in Levels of Serum Total Testosterone Concentration|Blood samples measured by Beckman assays and equipment.|"Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7"|loss to follow up|||ng/dl|||Number
2538845|NCT03091179|Secondary|Quality of Recovery|15-question survey, with each question scored from 0 to 10. Overall range 0-150, higher scores correspond to better outcome.|One week after surgery||||score on a scale||Standard Deviation|Mean
2538846|NCT03091179|Secondary|Change in Voice Handicap Index (VHI)|numerical scale, range from 0 to 40, with higher scores corresponding to worse outcome|Preoperative assessment and one month after surgery||||score on a scale||Standard Deviation|Mean
2538847|NCT03091179|Secondary|Opioid Consumption|Total oral opioid consumption in morphine milligram equivalents|Recovery room admission and discharge (up to 2 hours)||||MME: morphine milligram equivalents||Standard Deviation|Mean
2538848|NCT03091179|Secondary|Numerical Pain Rating Scores|A score from 0 to 10, higher scores corresponding to higher pain|Recovery room admission and discharge (up to 2 hours)||||score on a scale||Standard Deviation|Mean
2538849|NCT03091179|Secondary|Recovery Room Time||Up to 2 hours after procedure||||minutes||Standard Deviation|Mean
2538850|NCT03091179|Secondary|Alertness|Time required for the patient to become fully alert and oriented per standard recovery room evaluation|Recovery room admission (up to 30 min following admission to recovery room)||||minutes||Standard Deviation|Mean
2538851|NCT03091179|Primary|Duration of Surgery (Primary Surgical Outcome)||intraoperative (up to one hour)||||minutes||Standard Deviation|Mean
2538852|NCT03091179|Primary|Number of Suspension Repositioning Maneuvers (Primary Surgical Outcome)|Number of attempts required for the surgeon to reposition the patient's head for optimal surgical exposure using operating laryngoscope|intraoperative (up to 5 min)||||maneuvers||Standard Deviation|Mean
2538853|NCT03091179|Primary|Suspension Time (Primary Surgical Outcome)|Time required for the surgeon to position the patient's head and expose the surgical field for surgery using operating laryngoscope|intraoperative (up to 5 min)||||minutes||Standard Deviation|Mean
2538854|NCT03091179|Primary|Time to Awakening From Anesthesia (Primary Anesthesia Outcome)|time from end of surgery to responding to commands/extubation|intraoperative (up to 20 min)||||minutes||Standard Deviation|Mean
2538855|NCT03091179|Primary|Average Oxygen Saturation by Pulse Oximetry (SpO2) (Primary Anesthesia Outcome)||intraoperative (up to one hour)||||percentage of saturation (SpO2)||Standard Deviation|Mean
2538856|NCT03090958|Secondary|Client Satisfaction Questionnaire Score|Acceptability of AllyQuest will be assessed using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 was used to assess global intervention satisfaction. The CSQ-8 has eight items (quality of app, kind of service received from app, app met needs, recommend app to a friend, amount of help received from app, effectiveness of app for dealing with health problem, overall satisfaction, and willingness to use the app again). These domains are assessed on a 4-point response scale with individually specified anchors. Participant responses are scored from 1 to 4, and thus the possible total scores range from 8 to 32. Higher scores indicate greater satisfaction. The CSQ-8 has demonstrated high internal consistency across a large number of studies and has been used to evaluate technology-based interventions|4 weeks||||Scores on a scale||Standard Deviation|Mean
2538859|NCT03090958|Primary|Average Number of App Actions by Participants|Feasibility of AllyQuest will be based on usage as measured by the average number of activities completed (daily quests), articles read, and social posts made.|4 weeks|Missing data on 3 participants, hence only reporting data on 17 participants.|||Activities completed||Standard Deviation|Mean
2538863|NCT03090958|Primary|Number of Participants That Missed Follow up Interviews|Feasibility of AllyQuest will be based retention as measured by the number of missed follow up interviews. Follow up attempts will be documented.|4 weeks||||Participants|||Count of Participants
2538864|NCT03090958|Primary|Number of Participants That Were Enrolled of Those Screened|Feasibility of AllyQuest will be based on recruitment success as measured by the total number of individuals who are screened vs. the total number of individuals who are recruited and subsequently enrolled.|4 weeks|21 individuals were assessed for this outcome measure. The number analyzed were those that were recruited and screened for the study, but not enrolled.|||Participants|||Count of Participants
2538865|NCT03090256|Primary|Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)|VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.|Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation|All-Implanted Analysis Set|||subjects|Eyes||Number
2538866|NCT03090256|Primary|Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)|VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 60 cm is the VA at 60 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.|Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation|All-Implanted Analysis Set|||subjects|Eyes||Number
2538867|NCT03090256|Primary|Monocular Photopic Best Corrected Distance Visual Acuity (5 m)|Visual acuity (VA) was tested monocularly (each eye separately) under well-lit conditions with the subject's best spectacle correction at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.|Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation|All-Implanted Analysis Set|||subjects|Eyes||Number
2538868|NCT03090100|Secondary|Percent Improvement From Baseline in PASI Through Week 56|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.|Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 56|Full analysis set included all the participants randomized at Week 0. Here 'n' signifies the number of participants analyzed at specified point. Zero percent improvement was assigned from the point when participants met treatment failure criteria and no other data imputation was applied.|||Percent improvement||Standard Deviation|Mean
2538869|NCT03090100|Secondary|Percentage of Participants With IGA Responses Through Week 56|The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56|Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria or who had missing IGA score were considered as non-responders for the specific visit.|||Percentage of participants|||Number
2538870|NCT03090100|Secondary|Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56|PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that can range from 0 (no psoriasis) to 72.Participants with >=50%, >= 75%, >=90% and 100% improvement in PASI from baseline were considered PASI 50, 75, 90 and PASI 100 responders, respectively.|Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56|Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria or who had missing PASI score were considered as non-responders for the specific visit.|||Percentage of participants|||Number
2538871|NCT03090100|Secondary|Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90 percent (%) reduction in PASI relative to baseline.|Week 48|Full analysis set included all the participants randomized at Week 0 and who achieved PASI-90 response at Week 16. Participants who met treatment failure criteria prior to Week 48 or who had missing PASI score at Week 48 were considered as non-responders for this endpoint.|||Percentage of participants|||Number
2538879|NCT03090100|Secondary|Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48|The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 48|FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing IGA score at Week 48 were considered IGA cleared (0) or minimal (1) non-responders at Week 48.|||Percentage of participants|||Number
2538872|NCT03090100|Secondary|Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.|Week 48|Full analysis set included all the participants randomized at Week 0 and who achieved PASI 75 response at Week 12. Participants who met treatment failure criteria prior to Week 48 or who had missing PASI score at Week 48 were considered as non-responders for this endpoint.|||Percentage of participants|||Number
2538873|NCT03090100|Secondary|Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12|The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 12|Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 12 or who had a missing IGA score at Week 12 were considered non-responders for this endpoint.|||Percentage of participants|||Number
2538874|NCT03090100|Secondary|Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16|The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 16|Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 16 or who had a missing IGA score at Week 16 were considered non-responders for this endpoint.|||Percentage of participants|||Number
2538875|NCT03090100|Secondary|Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through Week 48|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Percentage of participants who achieved a PASI-90 response at all 7 visits from Week 24 to 48 (Week 24, 28, 32, 36, 40, 44 and 48) was reported.|Week 24 up to Week 48|FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had missing PASI score at any visit from Week 24 through 48 were considered as non-responders for this endpoint.|||Percentage of participants|||Number
2538876|NCT03090100|Secondary|Percentage of Participants Who Achieved a PASI-90 Response at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline.|Week 16|Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 16 or who had a missing PASI score at Week 16 were considered PASI 90 non-responders at Week 16.|||Percentage of participants|||Number
2538877|NCT03090100|Secondary|Percentage of Participants Who Achieved a PASI-75 Response at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.|Week 16|Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 16 or who had a missing PASI score at Week 16 were considered PASI 75 non-responders at Week 16.|||Percentage of participants|||Number
2538878|NCT03090100|Secondary|Percentage of Participants Who Achieved a PASI-90 Response at Both Week 16 and 48|Percentage of participants who achieved PASI-90 response at both Week 16 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline.|Week 16 and 48|FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing PASI score at Week 16 or 48 were considered as non-responders for this endpoint.|||Percentage of participants|||Number
2538897|NCT03089580|Primary|Tear Breakup Time Average|Three tear breakup time measurements will be taken of each eye. The averages of those eyes treated with intense pulsed light treatment will be compared to those eyes that received the sham treatment.|16.5 weeks||||Seconds||Standard Deviation|Mean
2547123|NCT02912195|Secondary|Pain Score (NRS 0-10)|Pain score recorded on the numeric rating scale 0-10.|At 10 minutes||||units on a scale||95% Confidence Interval|Mean
2538880|NCT03090100|Secondary|Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48|The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 48|FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing IGA score at Week 48 were considered IGA cleared (0) non-responders at Week 48.|||Percentage of participants|||Number
2538881|NCT03090100|Secondary|Percentage of Participants Who Achieved a PASI-100 Response at Week 48|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 100 response was defined as 100% reduction in PASI relative to baseline.|Week 48|FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing PASI score at Week 48 were considered PASI 100 non-responders at Week 48.|||Percentage of participants|||Number
2538882|NCT03090100|Secondary|Percentage of Participants Who Achieved a PASI-75 Response at Week 12|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.|Week 12|FAS population included. Participants who met treatment failure criteria prior to Week 12 or who had a missing PASI score at Week 12 were considered PASI 75 non-responders at Week 12.|||Percentage of participants|||Number
2538883|NCT03090100|Secondary|Percentage of Participants Who Achieved a PASI-90 Response at Week 12|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Due to failing to achieve superiority of prior secondary endpoint, no formal statistical testing was performed for endpoints from this point onwards.|Week 12|FAS population included. Participants who met treatment failure criteria prior to Week 12, who had a missing PASI score at Week 12 were considered PASI 90 non-responders at Week 12.|||Percentage of participants|||Number
2538884|NCT03090100|Secondary|Percentage of Participants Who Achieved a PASI-75 Response at Both Week 12 and 48|Percentage of participants who achieved PASI-75 response at both Week 12 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline.|Week 12 and 48|FAS population included. Participants who met treatment failure criteria (who discontinued study agent due to lack of efficacy or adverse event of psoriasis and/or who initiated protocol-prohibited psoriasis medications/therapies) prior to Week 48 or who had a missing PASI score at Week 12 or 48 were considered as non-responders for this endpoint.|||Percentage of participants|||Number
2538885|NCT03090100|Primary|Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.|Week 48|FAS population included. Participants who met treatment failure criteria (who discontinued study agent due to lack of efficacy or adverse event of psoriasis and/or who initiated protocol-prohibited psoriasis medications/therapies) prior to Week 48 or who had a missing PASI score at Week 48 were considered PASI 90 non-responders at Week 48.|||Percentage of participants|||Number
2538886|NCT03089879|Secondary|Percentage of Subjects With Anti-LPS S. Sonnei Concentrations Equal to or Above (≥) 121 EU/mL|Anti-LPS S.sonnei antibody concentrations were assessed by ELISA. The assay cut-off value was 121 EU/mL.|At Days 8, 15, 29 and 85 (7, 14, 28 and 84 days after vaccination)|The analysis was performed on the Full Analysis Set, which included all enrolled subjects who received a study vaccination and provided immunogenicity data at relevant time points.|||Percentage of subjects||95% Confidence Interval|Number
2538896|NCT03089580|Primary|Change in Scores of the Ocular Surface Disease Index Questionnaire|Patients completed the Ocular Surface Disease Index Questionnaire at each visit before they received the IPL and sham treatments. The questionnaire is assessed on a scale of 0 to 100 with 0 meaning normal and the higher scores representing greater dry eye disease severity. This questionnaire has been validated to assess ocular symptoms for a patient but cannot be separated by eye. Therefore, the results cannot be given by treatment vs. sham, but for the participant overall.|7 Months||||score on a scale||Standard Deviation|Mean
2538887|NCT03089879|Secondary|Percentage of Subjects With Seroresponse for Anti-LPS S. Sonnei|Seroresponse is aimed to define a significant increase in post-vaccination samples based on the biological performance of this specific serology assay and it is defined as follows: - If the baseline value is greater than 50 ELISA Units (EU) then an increase of at least 50% in the post-vaccination sample as compared to baseline [i.e. ((Post-vac minus baseline)/baseline)100% ≥ 50%]. - If the baseline value is less or equal to 50 EU then an increase of at least 25 EU in the post-vaccination sample as compared to baseline [i.e. (Postvac minus baseline) ≥ 25 EU.|At Days 8, 15, 29 and 85 (7, 14, 28 and 84 days after vaccination)|The analysis was performed on the Full Analysis Set, which included all enrolled subjects who received a study vaccination and provided immunogenicity data at relevant time points.|||Percentage of subjects||95% Confidence Interval|Number
2538888|NCT03089879|Secondary|Anti-LPS S. Sonnei IgG Geometric Mean Ratios|Within-subject Geometric mean ratios (GMRs) were computed for GMCs at 7, 14, 28 and 84 days after vaccination versus baseline (Day 1). The GMRs and 95% confidence intervals (CIs) were constructed by exponentiating the mean within-subject differences in log-transformed concentrations and the corresponding 95% CIs.|At Days 8, 15, 29 and 85 (7, 14, 28 and 84 days after vaccination)|The analysis was performed on the Full Analysis Set, which included all enrolled subjects who received a study vaccination and who provided immunogenicity data at relevant time points.|||Ratio||95% Confidence Interval|Geometric Mean
2538889|NCT03089879|Secondary|Concentrations of IgG Against LPS S. Sonnei O-antigen|Concentrations of IgG against S.sonnei O-antigen are presented as GMCs, expressed in ELISA units per milliliter (EU/mL).|At Days 15, 29 and 85 (14, 28 and 84 days after vaccination)|The analysis was performed on the Full Analysis Set, which included all enrolled subjects who received a study vaccination and who provided immunogenicity data at relevant time points.|||EU/mL||95% Confidence Interval|Geometric Mean
2538890|NCT03089879|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|A serious adverse event is defined as an untoward medical occurrence that at any dose resulted in death, was life-threatening, required hospitalization or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or in a congenital anomaly/birth defect; an important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.|Throughout the study period (from Day 1 up to Day 85)|The analysis was performed on the Overall Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited and unsolicited adverse event data were available. For the purpose of this analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group).|||Participants|||Count of Participants
2538891|NCT03089879|Secondary|Number of Subjects With Unsolicited Adverse Events|An unsolicited adverse event (AE) is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject. Any = occurrence of the symptom regardless of intensity grade. Grade 3 AE = AE that prevented daily activity. Possibly/probably related AE = AE determined by the investigator as possibly related (the administration of the investigational vaccine and AE are considered reasonably related in time and the AE could be explained by exposure to the investigational vaccine or by other causes) or probably related (exposure to the investigational vaccine and AE are reasonably related in time and no alternative explanation has been identified) to the study vaccination.|Throughout the study period (From Day 1 up to Day 85)|The analysis was performed on the Unsolicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom unsolicited adverse event data were available. For the purpose of this analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group).|||Participants|||Count of Participants
2538892|NCT03089879|Secondary|Number of Subjects With Solicited Systemic Adverse Events|Assessed solicited systemic adverse events include arthralgia, chills, fatigue, headache, malaise, myalgia and oral fever. Other indicators of solicited adverse events include prevention of pain and/or fever and treatment of pain and/or fever. Any symptom = occurrence of the symptom regardless of intensity grade. Fever = body temperature (measured orally) equal to or above (≥) 38.0 °C.|From 30 minutes through Day 7 post-vaccination|The analysis was performed on the Solicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited adverse event data were available. For the purpose of this analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group).|||Participants|||Count of Participants
2538893|NCT03089879|Secondary|Number of Subjects With Solicited Local Adverse Events|Assessed solicited local adverse events include injection site erythema, injection site induration and injection site pain. Any symptom = occurrence of the symptom regardless of intensity grade.|From 30 minutes through Day 7 post-vaccination|The analysis was performed on the Solicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited adverse event data were available. For the purpose of this analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo+Naïve Group).|||Participants|||Count of Participants
2538894|NCT03089879|Secondary|Number of Subjects With Abnormal Haematological Test Values|Assessed haematological parameters are: basophils (BAS), eosinophils (EOS), erythrocytes (ERCS), hematocrit (HCT), hemoglobin (HGB), leukocytes (LKCS), lymphocytes (LYM), monocytes (MONO), neutrophils (NEU) and platelet (PLT).|At Day 8 (7 days after vaccination) and Day 85 (84 days after vaccination)|The analysis was performed on the Overall Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited and unsolicited adverse event data were available. For the purpose of this analysis, the subjects from Placebo and Naïve Groups were pooled into a single group (Placebo + Naïve Group).|||Participants|||Count of Participants
2538895|NCT03089879|Primary|Concentrations of Immunoglobulin (IgG) Against Lipopolysaccharide (LPS) S. Sonnei O-antigen|IgG concentrations are expressed as Geometric Mean Concentrations (GMCs), as determined by the Enzyme-linked immunosorbent assay (ELISA) with Shigella sonnei (S.sonnei) O-antigen containing Lipopolysaccharide (LPS) coating antigen. Concentrations are presented as GMCs expressed in ELISA units per milliliter (EU/mL).|At Day 8 (7 days after vaccination)|The analysis was performed on the Full Analysis Set, which included all enrolled subjects who received a study vaccination and provided immunogenicity data at relevant time points.|||EU/mL||95% Confidence Interval|Geometric Mean
2538898|NCT03089216|Secondary|Color Evaluation|"Objective color evaluation:~The shade was determined using spectrophotometer VITA Easyshade, in which the parameters L*, a*, and b*, in which L* represents the value from 0 (black) to 100 (white) and a* and b* represent the shade, where a* is the measurement along the red-green axis and b* is the measurement along the yellow-blue axis.~The color alteration (ΔE) was determined by the differences between the values obtained at baseline and one month after the treatment, which was calculated with the formula: ΔE = [(ΔL *) 2 + (Δa *) 2 + (Δb *) 2]1/2.~In the Outcome Measure Data Table it was presented Mean and Standard Deviation of the color alteration (ΔE) between Baseline vs one month after bleaching for each group."|The evaluations were performed in the baseline period and one month after the treatment||||percentage of color change||Standard Deviation|Mean
2538899|NCT03089216|Primary|Tooth Sensitivity (TS)|"Tooth sensitivity (TS) was evaluated using a five-point rating scale (NRS), in which 0 = none (minimum value), 1 = mild, 2 = moderate, 3 = considerable, and 4 = severe (maximum value); and a visual analogue scale (VAS) in wich each participant placed a line perpendicular to a 10-cm-long line (on which 0 referred to no pain (minimum value) and 10 referred to severe pain (maximum value)).~Tooth sensitivity (TS) was evaluated during bleaching, and up to 48 hours postbleaching. The worst TS score or numeric value obtained in each assessment was considered for statistical purposes. It was calculated an average to obtain the median."|during bleaching, and up to 48 hours postbleaching||||score on a scale||Inter-Quartile Range|Median
2538900|NCT03088917|Secondary|Treatment Outcome|Sustained virological response in treated patients, defined as non-detectable HCV RNA at least 12 weeks after end of treatment|At least 12 weeks after end of treatment||||Participants|||Count of Participants
2538901|NCT03088917|Secondary|Fibrosis Progression|Fibrosis stage comparison in patients with a previously recorded fibrosis measurement, either with Fibroscan or liver biopsy. This previous measurement will be compared to the result of the Fibroscan performed during re-evaluation.|Baseline|Fibrosis progression could only be measured if patients had a previous fibrosis measurement, either by liver biopsy or liver stiffness measurement. This was the case in 3 out of 5 HCV RNA-positive patients, or 3 out of 10 re-evaluated patients.|||Participants|||Count of Participants
2538902|NCT03088917|Secondary|Genotype Distribution|Genotype distribution among RNA-positive patients|Baseline|HCV genotype was only determined in patients who were HCV RNA-positive at baseline, i.e. 5 out of a total of 10 re-evaluated patients.|||Participants|||Count of Participants
2538903|NCT03088917|Secondary|Reasons for Loss to Follow-up|through chart review or questioning screening event|Baseline||||Participants|||Count of Participants
2538904|NCT03088917|Primary|Liver Fibrosis Stage|Fibrosis stage according to elastography (liver stiffness in kPa) and/or liverbiopsy (staging according to Metavir). Stage F0/1 equals minimal fibrosis, stage F2 equals significant fibrosis and stage F3/F4 equals advanced fibrosis (including cirrhosis). For elastography, F0/1 is defined as liver stiffness <7.1 kPa, F2 as liver stiffness between 7.1 and 9.4 kPa and F3/F4 as liver stiffness >9.4 kPa. For liver biopsy, F0/1 is defined as the presence of no fibrosis or minimal fibrosis without the presence of septa, F2 as the presence of portal fibrosis with a few septa and F3/F4 as the presence of septal fibrosis or cirrhosis. The higher the fibrosis stage, the worse the outcome.|Baseline|Liver fibrosis was only assessed in patients who were HCV RNA-positive at baseline, i.e. in 5 out of a total of 10 re-evaluated patients.|||Participants|||Count of Participants
2538905|NCT03088267|Secondary|Change in Permanent Product Measure of Performance (PERMP-C) Score (Problems Answered Correctly)|Change from pre-dose in PERMP-C scores (Permanent Product Measure of Performance; defined as the number of problems attempted and number of problems solved correctly) at 30 minutes post-dose and at 3 hours post-dose. The PERMP-C is designed to assess compliance and academic productivity in school children. It is a 10-minute timed test in which the number of problems attempted and correct are assessed prior to and after an intervention. Scoring is based on problems attempted and correct. An increase in numerical score is indicative of improvement.|30 minutes postdose and 3 hours postdose|Intention to treat|||Change from baseline in PERMP score||Standard Error|Least Squares Mean
2538906|NCT03088267|Primary|Change in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Combined Scores, Baseline to 30 Minutes Post Dose|Change in SKAMP-C (Swanson, Kotkin, Agler, M-Flynn, and Pelham combined) score from pre-dose, by treatment. The SKAMP-C is a rating scale that assesses functional impairment related to ADHD in the classroom, including the performance of academic tasks, following class rules, and interacting with peers and adults in the classroom. The SKAMP-C is a 13-item, 7-score rating system (0=normal to 7=maximal impairment). The higher the score, the worse the impairment. A decrease from baseline in the combined (all 13 items) score indicates improvement. The SKAMP-C is used to assess the time course of treatment effects in laboratory classroom studies.|Change in SKAMP-C score from baseline to 30 minutes postdose.|Intent to Treat Population: 18 subjects|||number of questions answered correctly||Standard Error|Least Squares Mean
2538907|NCT03088137|Secondary|Percentage of Patients With the Evidence for Clinical Pregnancy|Confirmation of clinical pregnancy: ultrasound detection of intrauterine gestational sac and heart activity|The 10th week after embryo transfer|Per Protocol|||Percentage of patients (%)||95% Confidence Interval|Number
2538908|NCT03088137|Secondary|Percentage of Patients With Serum hCG More Than 25 IU/l|Biochemical pregnancy test: serum hCG more than 25 IU/l (days 12-17 after embryo transfer)|From date of randomization up to 42 days|Per Protocol|||Percentage of patients (%)||95% Confidence Interval|Number
2538909|NCT03088137|Secondary|Number of No-responders|The number of patients with no response to follitropin alfa treatment (absence of growing follicles, no any oocytes obtained at the day of ovum pick-up)|From date of randomization up to 8 days|Intention-to-Treat|||Participants|||Count of Participants
2538910|NCT03088137|Secondary|Number of Patients With Cycle Cancellation|The number of the ovarian hyperstimulation protocol cancellation (at the day of trigger of ovulation)|From date of randomization up to 16 days|Intention-to-Treat|||Participants|||Count of Participants
2538911|NCT03088137|Secondary|Number of Patients With Follitropin Alfa Dose Correction|The number of dose adjustments during the ovarian hyperstimulation protocol (increment 25-50 IU)|From date of randomization up to 16 days|Intention-to-Treat|||Participants|||Count of Participants
2538912|NCT03088137|Secondary|Number of Days of Follitropin Alfa Treatment|The duration of ovarian hyperstimulation protocol (at the day of trigger of ovulation)|From date of randomization up to 16 days|Intention-to-Treat|||Days||Standard Deviation|Mean
2538913|NCT03088137|Secondary|Total Dose of Follitropin Alfa|The total dose of the follitropin alfa administrated during the ovarian hyperstimulation protocol (measured in International Units - IU)|From date of randomization up to 16 days|Intention-to-Treat|||Total dose (IU)||Standard Deviation|Mean
2538914|NCT03088137|Secondary|Percentage of Patients With Embryo Transfer|The number of patients (and percentage) with embryo transfers on days 3 and 5 after ovum pick-up|From date of randomization up to 25 days|Per Protocol|||Participants|||Count of Participants
2538915|NCT03088137|Secondary|Fertilised Oocytes|The number of fertilised oocytes with the presence of two pronuclei: 2PN|From date of randomization up to 19 days|Intention-to-Treat|||Number of oocytes with 2PN||Standard Deviation|Mean
2538916|NCT03088137|Secondary|Mature Oocytes|The number of mature oocytes (MII stage of development)|From date of randomization up to 18 days|Intention-to-Treat|||Number of mature oocytes (MII stage)||Standard Deviation|Mean
2538917|NCT03088137|Secondary|Number of Follicles With Size ≥ 16 mm|The number of follicles 16 mm or over in diameter at the day of hCG (or GnRH-agonist) administration|From date of randomization up to 16 days|Intention-to-Treat|||Number of follicles||Standard Deviation|Mean
2538918|NCT03088137|Primary|Oocytes (Intention-to-Treat, ITT)|The total number of retrieved oocytes at the day of ovum pick-up. No more than 37 hours from the introduction of the trigger of ovulation (hCG or GnRH-agonist). The equivalence in the number of retrieved oocytes was tested using a predetermined equivalence margin of +/- 3.4 oocytes.|From date of randomization up to 18 days|Intention-to-Treat|||Number of retrieved oocytes||Standard Deviation|Mean
2538919|NCT03087643|Secondary|Change of Thickness of Vastus Lateralis|Evaluation of the architectural parameters (fascicle length, pinnation angle, and muscle thickness) of the vastus lateralis muscle by ultrasound|PRE and POST 4 weeks of treatment||||mm||Standard Deviation|Mean
2538920|NCT03087643|Secondary|Change of Range of Motion|Assessment of the passive force/joint angle relationship during knee passive mobilization|PRE and POST 4 weeks of treatment||||°||Standard Deviation|Mean
2538921|NCT03087643|Secondary|Change of Total Hemoglobin|Total hemoglobin [uM] in both, right and left vastus lateralis, was assessed by means of Near-infrared Spectroscopy [NIRS] during the sPLM test.|PRE and POST 4 weeks of treatment||||mmol/L||Standard Deviation|Mean
2538922|NCT03087643|Primary|Change of % FMD|Through the use of Flow-mediated Dilation (FMD) test , investigators assessed the dilation capacity of right the brachial artery (%FMD) during two minutes following 5-minute ischemic occlusion.|PRE and POST 4 weeks of treatment||||% of FMD||Standard Deviation|Mean
2538923|NCT03087643|Primary|Change of Delta Peak Blood Flow During sPLM|Through the use of single Passive Limb Movement (sPLM) test, investigators assessed PLM-induced hyperemia [ delta peak; ml/min] in the common femoral artery of both, right and left legs, during and 60 second after a single passive knee flexion and extension lasting 1 second.|PRE and POST 4 weeks of treatment||||ml/min||Standard Deviation|Mean
2538924|NCT03087604|Secondary|Number of Thoracic Spine Levels Attempted|the number of thoracic spine levels attempted will be recorded|Thirty minutes after start of procedure.|No data collected||||||
2538925|NCT03087604|Secondary|Time Required to Place the Epidural Catheter|The time required to place the epidural catheter will be recorded|From the initiation of procedure to end of procedure||||minutes||Standard Deviation|Mean
2538926|NCT03087604|Primary|Success Rate of Placement of a Thoracic Epidural|will be determined by the detection of a loss of sensation to cold (ice) in at least two contiguous dermatomal levels, 15 minutes after administration of a test dose of lidocaine through the epidural catheter. If a loss of cold sensation is found, then the epidural placement will be classified as successful. If no loss of cold sensation is found, then the epidural placement will be classified as unsuccessful.|15 minutes after administration of a test dose of lidocaine||||Participants|||Count of Participants
2538927|NCT03086551|Secondary|Change From Baseline in Cortical Excitability Post-Intervention|Motor evoked potential amplitude evoked by transcranial magnetic brain stimulation was recorded using electromyography over the first dorsal interosseous muscle of the stroke-affected hand. The means of ten trials at 120% (linear part of recruitment curve) and ten trials at 150% (recruitment curve plateau) of resting motor threshold were calculated and expressed in microvolts. Change in motor evoked potential amplitude elicited by transcranial magnetic stimulation intensities of 120% (linear part of recruitment curve) and ten trials at 150% (recruitment curve plateau) of resting motor threshold. Values are expressed percent change relative to pre-baseline values. Positive numbers represent an increase motor evoked potential from pre-baseline to post-intervention.|Baseline and post-intervention|All participants who completed at least one arm of the study|||percentage change||Standard Deviation|Mean
2538928|NCT03086551|Secondary|Motor Evoked Potential Amplitude (in Microvolts) at Pre-baseline and Post-Intervention|Motor evoked potential amplitude evoked by transcranial magnetic brain stimulation was recorded using electromyography over the first dorsal interosseous muscle of the stroke-affected hand. The means of ten trials at 120% (linear part of recruitment curve) and ten trials at 150% (recruitment curve plateau) of resting motor threshold were calculated and expressed in microvolts.|Baseline and post-intervention|All participants who completed at least one arm of the study|||microvolts||Standard Deviation|Mean
2538929|NCT03086551|Secondary|Change in Sequential Response Time Immediately Follow an Individual Bout of Non-invasive Brain Stimulation (e.g. Within Session)|Aggregate time to complete movements between a six sequential targets presented on a computer touch screen in front of the participant. The mean of ten sequences was calculated prior to application of Active+Motor Practice or Sham+Motor Practice for each intervention session and the first ten sequences of practice immediately following the specific form of non-invasive brain stimulation within each session. Change within a session was calculated by subtracting the post-stimulation score from the pre-stimulation score within a session. Positive values represent improved ability.|Within session baseline to ~8 minutes post-application of non-invasive stimulation within the same session|All participants who completed at least one arm of the study|||seconds||Standard Deviation|Mean
2538941|NCT03086356|Primary|Area Under the Concentration-time Curve of Idarucizumab in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)|AUC0-∞, area under the concentration-time curve of idarucizumab in plasma over the time interval from 0 extrapolated to infinity|-0.017, 0.083, 0.167, 0.317, 0.417, 0.45, 0.583, 0.917, 1.417, 2.083, 3.083, 4.083, 6.083, 10.083, 12.083, 24.083, 48.083, 72.083 hours (h)|PKS|||nanomoles (nmol)*hours (h) per litre (L)||Geometric Coefficient of Variation|Geometric Mean
2538930|NCT03086551|Secondary|Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test|The Jebsen-Taylor Hand Function Test is comprised of a series of unimanual tasks required for activities of daily living. Time to complete the Jebsen-Taylor Hand Function Test was assessed at baseline and post-intervention by taking the aggregate time to complete each activity. Change in time to complete the Jebsen-Taylor Hand Function Test between the baseline and post-intervention tests was derived by subtracting post-intervention score from baseline score. Positive scores indicate improvement in functional motor ability.|Baseline and post-intervention|All participants who completed at least one arm of the study|||seconds||Standard Deviation|Mean
2538931|NCT03086551|Primary|Change From Baseline in Sequential Response Time to Post-Intervention|Aggregate time to complete movements between a six sequential targets presented on a computer touch screen in front of the participant. The mean of ten sequences was calculated prior to any practice and at a delayed retention test (e.g. no warm up or preceding practice) post-intervention. Change between the baseline average and post-intervention average was also calculated by subtracting post-intervention score from pre-intervention score. Positive numbers represent improvement in ability.|Baseline and post-intervention|All participants who completed at least one arm of the study|||seconds||Standard Deviation|Mean
2538932|NCT03086447|Secondary|Monocular Distance Visual Acuity (VA)|"Monocular distance visual acuity was measured with the study lens using a Snellen distance VA chart at an optical distance of 20 feet. Observed VA data collected at fitting were dichotomized whether VA was 20/20 or better (optimal VA) or worse than 20/20. VA of 20/20 with a negative modifier was considered worse than 20/20. The number of eyes with 20/20 vision was reported for each study lens."|15 Minutes Post Lens Fitting|All subjects who have successfully completed all required visits without any major protocol deviations.|||Eyes|Number of Eyes||Number
2538933|NCT03086447|Secondary|Overall Handling|Overall Handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|Up to 4- Week Follow-up|All subjects who have successfully completed all required visits without any major protocol deviations.|||Units on a Scale||Standard Deviation|Mean
2538934|NCT03086447|Secondary|Overall Comfort|Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|Up to 4- Week Follow-up|All subjects who have successfully completed all required visits without any major protocol deviations.|||Units on a Scale||Standard Deviation|Mean
2538935|NCT03086447|Primary|Corneal Staining|Contact lens related corneal staining was assessed using slit lamp throughout the study. Corneal staining was graded using a 5-level scale: 0=no staining, 1=trace, 2=mild, 3=moderate and 4=severe. Corneal staining data collected during planned and unplanned visits were dichotomized whether the level of corneal stating was grade 3 or higher (unacceptable CS) or less than grade 3 (acceptable CS). The number of eyes with Grade 3 or higher was reported for each lens type.|Up to 4-Week Follow-up|All subjects who administered the test article and have at least one observation after lens insertion.|||Eyes|Number of Eyes||Number
2538936|NCT03086447|Primary|Absolute Lens Rotation|Lens rotation was assessed using slit lamp with beam that can be rotated. The rotational error (assume shortest distance) and direction (base toward the nose or temple) were calculated, and then absolute rotation was dichotomized whether absolute rotation was less than or equal to 10-degree (acceptable rotation) or greater (unacceptable rotation). The number of eyes with acceptable lens rotation for each lens was reported.|15-minutes Post Lens Insertion|All subjects who administered the test article and have at least one observation after lens insertion.|||Eyes|Number of Eyes||Number
2538937|NCT03086447|Primary|Lens Stability With Blink|Lens rotational stability with blink was assessed using slit lamp with beam that can be rotated. The stability of the scribe mark rotational position during a series of normal (unforced) blinks was assessed, and then dichotomized whether stability was less than or equal to 5-degree (acceptable stability) or greater (unacceptable stability). The number of eye with acceptable stability was reported for each lens.|15 Minutes Post Lens Fitting|All subjects who administered the test article and have at least one observation after lens insertion.|||Eyes|Number of Eyes||Number
2538938|NCT03086447|Primary|Lens Fit Acceptance|Lens fit characteristics were assessed using slit lamp with respect to lens position, movement and tightness. Each lens fit collected at fitting (visit 1) was judged being either acceptable or unacceptable based on the static and dynamic fit characteristic. The number of eyes with acceptable lens fit was reported for each study lens.|15 Minutes Post Lens Fitting|All subjects who administered the test article and have at least one observation after lens insertion.|||Eyes|Number of Eyes||Number
2538939|NCT03086447|Primary|Monocular Distance Visual Acuity (VA)|"Monocular distance visual acuity was measured with the study lens using a Snellen distance VA chart at an optical distance of 20 feet throughout the study. Observed VA data collected during all planned visits were dichotomized whether VA was 20/40 or better (acceptable VA) or worse than 20/40 (unacceptable VA). VA of 20/40 with a negative modifier was considered worse than 20/40. The number of eye with acceptable VA was reported for each study lens."|Up to 4-Week Follow-up|All subjects who administered the test article and have at least one observation after lens insertion.|||Eyes|Number of Eyes||Number
2538940|NCT03086356|Primary|Amount of Idarucizumab Eliminated in Urine Over the Time Interval From 0 to 72 Hours (h) (Ae0-72)|"Ae0-72, amount of idarucizumab eliminated in urine over the time interval from 0 to 72 h.~As per the protocol, day is counted as Day 1 = 0:00"|0-2 h, 2-6 h, 6-10 h, 10-12 h,12-14h, 14-26 h, 26-50 h, 50-74 h after drug administration of dabigatran etexilate on Day 4|PKS|||micromole (μmol)||Geometric Coefficient of Variation|Geometric Mean
2539019|NCT03086265|Primary|Duration of Surgery|Recorded from the moment of the introduction of the operating laryngoscope in patient's mouth to withdrawing the laryngoscope at the completion of surgery.|Duration of surgery (average approximately 1 hour)||||minutes||Standard Deviation|Mean
2538942|NCT03086356|Secondary|For Unbound Sum Dabigatran: Area Under the Concentration-time Curve of the Dabigatran in Plasma at Steady State Over the Time Interval 2 Hours-12 Hours|"For unbound sum dabigatran: AUC 2-12,ss (Area under the concentration-time curve of the dabigatran in plasma at steady state over the time interval 2 hours-12 hours).~As per the protocol, day is counted as Day 1 = 0:00."|Day 4: 74h, 74.5h, 75h, 76h, 78h, 80h, 84h; Day 11: 242h, 242.083h, 242.25h, 242.333h 243.333h, 244h, 246h, 248h, 252h|PKS|||nanograms*hours/ milliliter||Geometric Coefficient of Variation|Geometric Mean
2538943|NCT03086356|Secondary|For Sum Dabigatran: Amount of the Analyte Excreted in Urine at Steady State Over the Time Interval 0-74 Hours (Ae0-74,ss ) on Day 4 and Day 11|"For sum dabigatran: Ae0-74,ss (amount of the analyte excreted in urine at steady state over the time interval 0-74) on day 4 and day 11 if feasible.~As per the protocol, day is counted as Day 1 = 0:00"|0-2 h, 2-6 h, 6-10 h, 10-12 h,12-14h, 14-26 h, 26-50 h, 50-74 h after drug administration of dabigatran etexilate on Day 4 and Day 11.|PKS|||μg (microgram)||Geometric Coefficient of Variation|Geometric Mean
2538944|NCT03086356|Primary|For Diluted Thrombin Time: Area After Subtraction of Baseline Area From Area Under the Effect Curve Over the Time Interval From 2 - 12 Hours (AUEC Above,2-12) on Day 4 and Day 11|"For diluted thrombin time: AUEC above,2-12 (area after subtraction of baseline area from area under the effect curve over the time interval from 2 - 12) on day 4 and day 11.~The standard deviation (SD) presented is actually the percentage coefficient of variation (CV %)"|Day 4 and day 11|Pharmacodynamic set (PDS): The PDS included all subjects in the TS who provided at least one evaluable pre-dose and one on-treatment PD observation after the start of dabigatran administration.|||hours||Standard Deviation|Mean
2538945|NCT03086356|Primary|Maximum Measured Concentration of Idarucizumab in Plasma (Cmax)|Cmax, maximum measured concentration of idarucizumab in plasma|-0.017, 0.083, 0.167, 0.317, 0.417, 0.45, 0.583, 0.917, 1.417, 2.083, 3.083, 4.083, 6.083, 10.083, 12.083, 24.083, 48.083, 72.083 hours (h)|Pharmacokinetic set (PKS): The PKS included all subjects of the Treated set (TS) who had at least one Pharmacokinetic (PK) parameter analysed.|||nanomoles (nmol) per litre (L)||Geometric Coefficient of Variation|Geometric Mean
2538946|NCT03086330|Secondary|Change in Fundoscopy|Fundoscopy results for both left and right eyes are presented for week 0 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538947|NCT03086330|Secondary|Change in Physical Examination: Thyroid Gland|Physical examination (thyroid gland) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week -2, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538948|NCT03086330|Secondary|Change in Physical Examination: Lymph Node Palpation|Physical examination (lymph node palpation) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week -2, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538949|NCT03086330|Secondary|Change in Physical Examination: Respiratory System|Physical examination (respiratory system) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week -2, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538950|NCT03086330|Secondary|Change in Physical Examination: Skin|Physical examination (skin) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week -2, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538951|NCT03086330|Secondary|Change in Physical Examination: Gastrointestinal System Including Mouth|Physical examination (gastrointestinal system including mouth) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week -2, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538952|NCT03086330|Secondary|Change in Physical Examination: Cardiovascular System|Physical examination (cardiovascular system) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week -2, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538966|NCT03086330|Secondary|Change in Biochemistry: Aspartate Aminotransferase|Change from baseline (week 0) in aspartate aminotransferase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||U/L||Geometric Coefficient of Variation|Geometric Mean
2538953|NCT03086330|Secondary|Change in Physical Examination: Central and Peripheral Nervous System|Physical examination (central and peripheral nervous system) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week -2, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538954|NCT03086330|Secondary|Change in Physical Examination: General Appearance|Physical examination (general appearance) results are presented for week -2 (baseline) and week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week -2, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538955|NCT03086330|Secondary|Change in Electrocardiogram|Electrocardiogram (ECG) results are presented for week 0 (baseline) and week 30. ECG finding are presented as percentage of participants with normal, abnormal non-clinically significant (NCS) and abnormal clinically significant (CS) ECG values. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 42 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538956|NCT03086330|Secondary|Change in Pulse|Change from baseline (week 0) in pulse rate was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||beats/min||Standard Deviation|Mean
2538957|NCT03086330|Secondary|Change in Calcitonin|Change from baseline (week 0) in calcitonin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||ng/L||Geometric Coefficient of Variation|Geometric Mean
2538958|NCT03086330|Secondary|Change in Biochemistry: Creatinine|Change from baseline (week 0) in creatinine was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||umol/L||Geometric Coefficient of Variation|Geometric Mean
2538959|NCT03086330|Secondary|Change in Biochemistry: Estimated Glomerular Filtration Rate (eGFR)|Change from baseline (week 0) in eGFR was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||mL/min/1.73m2||Geometric Coefficient of Variation|Geometric Mean
2538960|NCT03086330|Secondary|Change in Biochemistry: Bicarbonate|Change from baseline (week 0) in bicarbonate was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||mmol/L||Geometric Coefficient of Variation|Geometric Mean
2538961|NCT03086330|Secondary|Change in Biochemistry: Sodium|Change from baseline (week 0) in sodium was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||mmol/L||Geometric Coefficient of Variation|Geometric Mean
2538962|NCT03086330|Secondary|Change in Biochemistry: Potassium|Change from baseline (week 0) in potassium was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||mmol/L||Geometric Coefficient of Variation|Geometric Mean
2538963|NCT03086330|Secondary|Change in Biochemistry: Calcium (Total)|Change from baseline (week 0) in albumin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||mmol/L||Geometric Coefficient of Variation|Geometric Mean
2538964|NCT03086330|Secondary|Change in Biochemistry: Albumin|Change from baseline (week 0) in albumin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||g/dL||Geometric Coefficient of Variation|Geometric Mean
2538965|NCT03086330|Secondary|Change in Biochemistry: Total Bilirubin|Change from baseline (week 0) in total bilirubin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||umol/L||Geometric Coefficient of Variation|Geometric Mean
2539020|NCT03086265|Primary|Number of Suspension Adjustments|Number of adjustments of the suspension laryngoscope.|Duration of surgery (average approximately 1 hour)||||adjustments||Standard Deviation|Mean
2538967|NCT03086330|Secondary|Change in Biochemistry: Alanine Aminotransferase|Change from baseline (week 0) in alanine aminotransferase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||U/L||Geometric Coefficient of Variation|Geometric Mean
2538968|NCT03086330|Secondary|Change in Biochemistry: Alkaline Phosphatase|Change from baseline (week 0) in alkaline phosphatase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||U/L||Geometric Coefficient of Variation|Geometric Mean
2538969|NCT03086330|Secondary|Change in Biochemistry: Lipase|Change from baseline (week 0) in lipase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||U/L||Geometric Coefficient of Variation|Geometric Mean
2538970|NCT03086330|Secondary|Change in Biochemistry: Amylase|Change from baseline (week 0) in amylase was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||U/L||Geometric Coefficient of Variation|Geometric Mean
2538971|NCT03086330|Secondary|Change in Haematology: Leucocytes|Change from baseline (week 0) in leucocytes was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||10^9 leucocytes/L||Geometric Coefficient of Variation|Geometric Mean
2538972|NCT03086330|Secondary|Change in Haematology: Erythrocytes|Change from baseline (week 0) in erythrocytes was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||10^12 erythrocytes/L||Geometric Coefficient of Variation|Geometric Mean
2538973|NCT03086330|Secondary|Change in Haematology: Thrombocytes|Change from baseline (week 0) in thrombocytes was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||10^9 thrombocytes/L||Geometric Coefficient of Variation|Geometric Mean
2538974|NCT03086330|Secondary|Change in Haematology: Haematocrit|Change from baseline (week 0) in haematocrit was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||% of red blood cells||Geometric Coefficient of Variation|Geometric Mean
2538975|NCT03086330|Secondary|Change in Haematology: Haemoglobin|Change from baseline (week 0) in haemoglobin was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days.|Week 0, week 30|SAS which included all participants exposed to at least one dose of trial product. Number analyzed = number of participants with available data.|||mmol/L||Geometric Coefficient of Variation|Geometric Mean
2538976|NCT03086330|Secondary|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes|Hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred within the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 42 days. Severe or BG-confirmed symptomatic hypoglycaemia: an episode that was severe according to the ADA classification or confirmed by a PG value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Week 0 - week 30|SAS, which included all participants exposed to at least one dose of trial product.|||Episodes|||Number
2538977|NCT03086330|Secondary|Number of Treatment-emergent Adverse Events (TEAEs)|A TEAE was defined as an event that has onset date (or increase in severity) during the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 42 days.|Week 0 - week 30|Safety analysis set (SAS), which included all participants exposed to at least one dose of trial product (semaglutide or placebo).|||Events|||Number
2538978|NCT03086330|Secondary|HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 10%|Percentage of participants with HbA1c reduction equal to or above 1%-point and weight loss equal to or above 10% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.|After 30 weeks|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538979|NCT03086330|Secondary|HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 5%|Percentage of participants with HbA1c reduction equal to or above 1%-point and weight loss equal to or above 5% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.|After 30 weeks|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538992|NCT03086330|Secondary|Change in Waist Circumference|Change from baseline (week 0) in waist circumference was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.|Week 0, week 30|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||cm||Standard Deviation|Mean
2538980|NCT03086330|Secondary|HbA1c Reduction Equal to or Above 1%-Point and Weight Loss Equal to or Above 3%|Percentage of participants with HbA1c reduction equal to or above 1%-point and weight loss equal to or above 3% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.|After 30 weeks|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538981|NCT03086330|Secondary|HbA1c Reduction Equal to or Above 1%-Point|Percentage of participants with HbA1c reduction equal to or above 1%-point was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.|After 30 weeks|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538982|NCT03086330|Secondary|HbA1c Below 7.0% (53 mmol/Mol) Without Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain|Percentage of participants with HbA1c below 7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain from their baseline (week 0) body weight was evaluated at week 30. Severe or blood glucose (BG)-confirmed symptomatic hypoglycaemia: an episode that was severe according to the American Diabetes Association (ADA) classification or confirmed by a plasma glucose (PG) value below 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment without rescue medication' observation period.|After 30 weeks|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538983|NCT03086330|Secondary|Weight Loss Equal to or Above 10%|Percentage of participants with weight loss equal to or above 10% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.|After 30 weeks|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538984|NCT03086330|Secondary|Weight Loss Equal to or Above 5%|Percentage of participants with weight loss equal to or above 5% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.|After 30 weeks|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538985|NCT03086330|Secondary|Weight Loss Equal to or Above 3%|Percentage of participants with weight loss equal to or above 3% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.|After 30 weeks|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538986|NCT03086330|Secondary|HbA1c Equal to or Below 6.5% (48 mmol/Mol)|Percentage of participants with HbA1c equal to or below 6.5% (48 mmol/mol) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.|After 30 weeks|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538987|NCT03086330|Secondary|HbA1c Below 7.0% (53 mmol/Mol)|Percentage of participants with HbA1c below 7.0% (53 mmol/mol) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.|After 30 weeks|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||Percentage of participants|||Number
2538988|NCT03086330|Secondary|Change in Scores for Selected Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Score (Sum of 6 of 8 Items) and the 8 Items Separately|Change from baseline (week 0) in PRO questionnaire, DTSQ was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. The DTSQ measures satisfaction with diabetes treatment. The DTSQ consists of 8 items evaluating 6 aspects of treatment satisfaction and 2 perceived recent event rates of hyperglycemia/hypoglycemia. Each item is scored on a 7- point Likert scale ranging from 0 (very dissatisfied) to 6 (very satisfied). Items evaluating 6 aspects (items 3-8) of treatment satisfaction are summed to produce a total treatment satisfaction score; DTSQ status total scores range from 0-36, with higher scores indicating greater satisfaction; the perceived frequency of hyperglycemia/hypoglycemia items are scored separately, with lower scores indicating better perceived blood glucose control.|Week 0, week 30|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||Scores on a scale||Standard Deviation|Mean
2538989|NCT03086330|Secondary|Change in Scores for Selected Patient Reported Outcomes: Short-form Health Survey (SF-36v2TM): Total Scores (Physical Component and Mental Component) and Scores From the 8 Domains|Change from baseline (week 0) in patient reported outcome (PRO) questionnaire, SF-36v2TM was evaluated at week 30. The SF-36v2™ questionnaire was used to assess the overall health related quality of life of participants. This questionnaire contains 36 items and measures the individual overall health related quality of life on 8 domains: 1) Physical functioning, 2) Role functioning, 3) Bodily pain, 4) General health, 5) Vitality, 6) Social functioning, 7) Role emotional and 8) Mental health. Each item is scored on a scale from 1 to either 2, 3, 5, or 6; each item score is then converted to a scale of 0-100, representing the percentage of total possible score achieved and with higher scores indicating a higher health status; items on the same scale are then averaged to obtain the 8 scale scores. Physical component summary (PCS) includes domains 1-4 and mental component summary (MCS) includes domains 5-8. Higher PCS and MCS scores on a scale of 0-100 indicate a higher health status.|Week 0, week 30|FAS which included all randomised participants. Number analyzed = number of participants with available data. Results are based on the 'on-treatment without rescue medication' observation period.|||Scores on a scale||Standard Deviation|Mean
2538990|NCT03086330|Secondary|Change in Diastolic Blood Pressure|Change from baseline (week 0) in diastolic blood pressure was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.|Week 0, week 30|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||mmHg||Standard Deviation|Mean
2538991|NCT03086330|Secondary|Change in Systolic Blood Pressure|Change from baseline (week 0) in systolic blood pressure was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.|Week 0, week 30|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||mmHg||Standard Deviation|Mean
2538993|NCT03086330|Secondary|Change in Body Mass Index|Change from baseline (week 0) in body mass index (BMI) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. BMI was calculated as 'body weight in kg/(height in meters) x (height in meters)'.|Week 0, week 30|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||Kg/sqm||Standard Deviation|Mean
2538994|NCT03086330|Secondary|Change in Body Weight (%)|Percent (%) change from baseline (week 0) in body weight (measured in kilogram (kg)) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.|Week 0, week 30|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||Percentage||Standard Deviation|Mean
2538995|NCT03086330|Secondary|Change in Fasting Blood Lipid, Triglycerides|Change from baseline (week 0) in triglycerides (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.|Week 0, week 30|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2538996|NCT03086330|Secondary|Change in Fasting Blood Lipid, High-density Lipoprotein (HDL) Cholesterol|Change from baseline (week 0) in HDL (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.|Week 0, week 30|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2538997|NCT03086330|Secondary|Change in Fasting Blood Lipid, Low-density Lipoprotein (LDL) Cholesterol|Change from baseline (week 0) in LDL (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.|Week 0, week 30|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2538998|NCT03086330|Secondary|Change in Fasting Blood Lipid, Total Cholesterol|Change from baseline (week 0) in total cholesterol (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.|Week 0, week 30|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2538999|NCT03086330|Secondary|Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean Post Prandial Increment (Over All Meals)|Change from baseline (week 0) in mean post prandial increment (over all meals) in the SMPG, 7-point profile was evaluated at week 30. The mean increment over all meals was derived as the mean of all available meal increments. Results are based on the 'on-treatment without rescue medication' observation period.|Week 0, week 30|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2539000|NCT03086330|Secondary|Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean 7-point Profile|Change from baseline (week 0) in mean of the SMPG, 7-point profile was evaluated at week 30. Mean 7-point profile (the area under the profile) was calculated using the trapezoidal method and divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period. Participants measured their plasma glucose at 7 different time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime.|Week 0, week 30|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2539001|NCT03086330|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline (week 0) in FPG was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.|Week 0, week 30|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2539002|NCT03086330|Secondary|Change in Body Weight (kg)|Change from baseline (week 0) in body weight was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period.|Week 0, week 30|FAS which included all randomised participants. Number analyzed = number of participants with available data.|||Kg||Standard Deviation|Mean
2539003|NCT03086330|Primary|Change in HbA1c|Change from baseline (week 0) in HbA1c was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: 1) the last dose of trial product + 7 days or 2) initiation of rescue medication.|Week 0, week 30|Full analysis set (FAS), which included all randomised participants. Number analyzed = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2539004|NCT03086265|Secondary|Quality of Recovery (QoR)15 Score|The QoR15 has 15 questions each is on a scale of 0-10 to measure patient functionality. Scores are summed for an overall range of 0-150, with higher scores corresponding to better recovery.|Prior to procedure, and 1-2 hours after procedure||||score on a scale||Standard Deviation|Mean
2539005|NCT03086265|Secondary|Analgesic Consumption|Analgesic consumption was measured in oral morphine milligram equivalents (MME)|Recovery room to 7th postoperative day||||MME||Standard Deviation|Mean
2539006|NCT03086265|Secondary|Pain Score at Discharge From Recovery Room|Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).|Duration of recovery room stay (average approximately 1 hour)||||score on a scale||Standard Deviation|Mean
2539007|NCT03086265|Secondary|First Pain Score in Recovery Room|Pain scale was 0-10 (0 = no pain, 10 - worst pain imaginable).|Duration of recovery room stay (average approximately 1 hour)||||score on a scale||Standard Deviation|Mean
2539008|NCT03086265|Secondary|Recovery Room Discharge-ready Time|From admission to recovery room, to discharge from recovery room|Duration of recovery room stay (average approximately 1 hour)||||minutes||Standard Deviation|Mean
2539009|NCT03086265|Secondary|Time to Patient Being Alert and Oriented x 4|Recorded from patient's admission to the recovery room to patient's orientation to person, place, time, and situation as assessed by the recovery room nurse.|Duration of surgery (average approximately 1 hour)||||minutes||Standard Deviation|Mean
2539010|NCT03086265|Secondary|Total Labetalol Dose (Vasoactive Drug)||Duration of surgery (average approximately 1 hour)|Participants who received labetalol are included in the analysis.|||mg||Standard Deviation|Mean
2539022|NCT03086265|Primary|Awakening/Extubation Time|Recorded from the end of surgery until the return of patient's protective airway reflexes and patient opening eyes to command.|Duration of surgery (average approximately 1 hour)||||minutes||Standard Deviation|Mean
2539023|NCT03086265|Primary|Systemic Vascular Resistance Index (SVRI)|SVRI equals systemic vascular resistance (SVR) times BSA. SVR is the resistance to blood flow through the systemic circulation and it was measured in Wood units. Wood unit =80 dyne*seconds per centimetre^5 (dyne*sec/cm^5).|Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)|Participants with measurements at each respective time point are included in the analysis.|||dynes*s/cm^5/m^2||Standard Deviation|Mean
2539024|NCT03086265|Primary|Cardiac Index (CI)|Cardiac index: A cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area (m^2) to yield the cardiac index.|Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)|Participants with measurements at each respective time point are included in the analysis.|||L/min/m^2||Standard Deviation|Mean
2539025|NCT03086265|Primary|Stroke Volume Index (SVI)|Stroke volume - the volume of blood ejected from a ventricle at each beat of the heart, equal to the difference between the end-diastolic volume and the end-systolic volume. The stroke volume index is a method of relating the stroke volume to the size of the person by dividing the stroke volume by the body surface area (BSA) (m^2).|Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)|Participants with measurements at each respective time point are included in the analysis.|||ml/b/m^2||Standard Deviation|Mean
2539026|NCT03086265|Primary|Mean Arterial Pressure (MAP)||Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)|Participants with measurements at each respective time point are included in the analysis.|||mmHg||Standard Deviation|Mean
2539027|NCT03086265|Primary|Heart Rate||Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour)|Participants with measurements at each respective time point are included in the analysis.|||beats per minute||Standard Deviation|Mean
2539028|NCT03086265|Primary|pH in Blood|The pH range is 0 to 14, with 7 being neutral. A pH of less than 7 indicate acidity, whereas a pH of greater than 7 indicates a base.|Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)|This outcome was assessed in THRIVE participants only. Participants with measurements at each respective time point are included in the analysis.|||pH||Standard Deviation|Mean
2539029|NCT03086265|Primary|Partial Pressure of Carbon Dioxide in the Arterial Blood (PaCO2)||Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)|This outcome was assessed in THRIVE participants only. Participants with measurements at each respective time point are included in the analysis.|||mmHg||Standard Deviation|Mean
2539030|NCT03086265|Primary|Partial Pressure of Oxygen in the Arterial Blood (PaO2)||Induction, 10, 20, 30, 40m following induction, spontaneous ventilation (approximately 1 hour), recovery room (approximately 1 hour)|This outcome was assessed in THRIVE participants only. Participants with measurements at each respective time point are included in the analysis.|||mmHg||Standard Deviation|Mean
2539031|NCT03086265|Primary|Lowest Intraoperative Peripheral Oxygen Saturation (SpO2)|Peripheral oxygen saturation is an estimate of the amount of oxygen in the blood.|Duration of surgery (average approximately 1 hour)||||percentage of oxygen||Standard Deviation|Mean
2539032|NCT03086135|Secondary|Softpad Use|A question was asked if the subjects used softpads; yes or no could be ticked.|6 weeks, 3, 6 and 12 months|Some of the subjects did not answer the question at all visits.|||Participants|||Count of Participants
2539033|NCT03086135|Secondary|Magnet Choice|Available magnet strengths: 1/2, 1, 2, 3, 4, 5 or 6, where 1/2 is the weakest and 6 the strongest.|4, 6 weeks, 3, 6 and 12 months|Some of the subjects did not perform all visits.|||Participants|||Count of Participants
2539034|NCT03086135|Secondary|Comfort|Comfort of sound processor measured with a visual analogue scale where 0% is defined as no comfort at all and 100% as most comfortable imaginable, i.e. minimum 0, maximum 100.|6 weeks, 3, 6 and 12 months|Some of the subjects did not answer the question at all visits.|||units on a scale||Standard Deviation|Mean
2539035|NCT03086135|Secondary|Daily Usage Time of Sound Processor|Sound processor usage time measured as hours per day.|6 weeks, 3, 6 and 12 months|Some of the subjects did not answer the question at all visits.|||hours per day||Standard Deviation|Mean
2539036|NCT03086135|Secondary|Incision Type|Surgical information: a question was asked regarding what type of incision had been used; C-shaped flap, posterior based flap or other could be ticked.|Visit 2, surgery|For two subjects two alternatives were checked.|||Participants|||Count of Participants
2539037|NCT03086135|Secondary|Location of BI300 Implant|"Surgical information: where is the location of the BI300 implant, measured in two different ways:~Alternative 1 used for the first 6 subjects: Location from the ear channel in mm.~Alternative 2 used for the rest of the population 45 subjects, after an amendment: measured in mm horizontally and vertically from ear channel. and the distance in mm between the receiver and the coil.~Value 9.64 mm vertically from ear channel is correct."|Visit 2, surgery|Localization of the BI300 implant measured in two different ways; 6 subjects with alternative 1, 45 subjects with alternative 2.|||mm||Standard Deviation|Mean
2539038|NCT03086135|Secondary|Type of Anaesthesia|Surgical information: a question is asked which type of anaesthesia has been used: local or general can be ticked.|Visit 2, surgery||||Participants|||Count of Participants
2539039|NCT03086135|Secondary|Bone Polishing/Removal at Implant Site|Surgical information: a question is asked if bone polishing/removal at Implant site has been performed. Yes or No can be ticked.|Visit 2, surgery||||Participants|||Count of Participants
2539040|NCT03086135|Secondary|Soft Tissue Reduction|"Surgical information: a question was asked if soft tissue reduction had been performed. Could be answered by ticking a box for Yes or No."|Visit 2, surgery||||Participants|||Count of Participants
2539041|NCT03086135|Secondary|Soft Tissue Thickness|Surgical information: Soft tissue thickness was measured in mm|Visit 2, surgery||||mm||Standard Deviation|Mean
2539042|NCT03086135|Secondary|Surgical Information: Time of Surgery|Surgery time in minutes between first incision and last suture|Visit 2, surgery||||minutes||Standard Deviation|Mean
2539043|NCT03086135|Secondary|Adaptive Speech Recognition in Noise, With Reference Device BP110|The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband;measured with free field hearing test Adaptive speech recognition in noise which was measured as signal to noise ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB. A positive SNR-value reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and represent a better hearing in a noisy environment.|Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.|Some of the subjects did not perform the test at all visits.|||SNR||Standard Deviation|Mean
2539044|NCT03086135|Secondary|Speech in Quiet at 50, 65 and 80 dB SPL, With Reference Device BP110|The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband measured as free-field hearing test; Speech in quiet [% correctly perceived words at 50, 65 and 80 dB SPL]. The change in percent points is presented. A positive value indicates an improved ability to perceive words in quiet at the specified decibel (dB) level a negative value represent an impairment.|Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.|Some of the subjects did not perform all measurements at all visits.|||Percentage of correctly perceived words||Standard Deviation|Mean
2539045|NCT03086135|Secondary|Hearing Performance: Threshold Audiometry Individual Frequences With Reference Device BP110|The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband, measured as free-field hearing test; Threshold audiometry individual frequencies (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz) is presented. The units reported are decibels (dB). A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.|Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.|Some of the subjects did not perform all measurements at all visits.|||dB||Standard Deviation|Mean
2539046|NCT03086135|Secondary|Hearing Performance: Threshold Audiometry PTA4, With Reference Device BP110|The change of hearing performance with the OSIA System at 4 weeks, 3, 6 and 12 months compared to the pre-operative aided situation with BP110 on softband, measured as free-field hearing test; Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. The units reported for PTA4 are decibels (dB). A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.|Baseline before surgery, 4 weeks, 3, 6 and 12 months.|Some of the subjects did not perform a PTA4 measurement at one or more visits.|||dB||Standard Deviation|Mean
2539047|NCT03086135|Secondary|Speech, Spatial and Qualities of Hearing Scale (SSQ) at 3 and 12 Months|"The change of speech, spatial and hearing experiences from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months using the SSQ scale is presented. All subscales (speech, spatial, quality) range from 0 to 10, where 0 represents can not hear at all, and 10 hear perfectly. Total score is a average of the subscales. A positive value indicates improved hearing, a negative value indicates impaired hearing."|Baseline before surgery and 3 and 12 months after surgery|Some of the subjects did not answer all questions at one or both visits.|||units on a scale||Standard Deviation|Mean
2539048|NCT03086135|Secondary|Health Utility Index (HUI) at 3 and 12 Months|The change of health status and health related quality of life from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months using the generic quality of life scale Health Utilities Index (HUI3) is presented. All subscales (comprehensive health state, vision, hearing, speech, ambulation, dexterity, emotion, pain, cognition) range from 0-1. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The difference between the unaided and the aided situation is presented. In an ultimate case the unaided value could be 0 and the aided 1, the result is then 1.0. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.|Baseline before surgery and 3 and 12 months after surgery|Some of the subjects did not answer all questions in the questionnaire at one or both time-points.|||units on a scale||Standard Deviation|Mean
2539049|NCT03086135|Secondary|Abbreviated Profile of Hearing Aid Benefit (APHAB) at 3 and 12 Months|The change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 and 12 months is presented. All subscales range from 0-100%, total score is the average of all subscales 0-100%, where 0% indicates no problem and 100% indicates always problem. The difference between the unaided and the aided situation is presented. In an ultimate case the unaided value could be 100 and the aided 0, the result is then 100. A positive value indicates an improvement, a negative value an impairment.|Baseline before surgery, 3 and 12 months after surgery|Some of the subjects did not answer some of the questions at one or more visits.|||units on a scale||Standard Deviation|Mean
2539050|NCT03086135|Secondary|Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months|The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 months measured as free field hearing test Adaptive speech recognition in noise, is presented. Adaptive speech recognition in noise was measured as Signal to Noise Ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the Speech-to-Noise Ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB, for example if 50% of the speech is received correctly at 55 dB the SNR value is -10. A positive SNR-value (Speech to Noise Ratio) reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and reflects a better hearing in a noisy environment.|Baseline before surgery, 4 weeks, 6 and 12 months after surgery|Some subjects did not perform the test at one or more visits.|||SNR (Speech in Noise Ratio)||Standard Deviation|Mean
2539263|NCT03077659|Secondary|Concentration of Paclitaxel in the Systemic Circulation|Pharmacokinetic samples were taken on Day 1 at 1, 2, 4, and 6 hours post-injection, and weekly until prostatectomy. All numeric paclitaxel concentration data above the Lower Limit of Quantitation (25 pg/mL) was tabulated by cohort.|Day 1, Day 8, Day 15, Day 22, and Day 29|Full Analysis Set|||Plasma paclitaxel concentration (pg/mL)||Standard Deviation|Mean
2539051|NCT03086135|Secondary|Speech in Quiet at 50, 65 and 80 dB SPL, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months|The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 4 weeks, 3, 6 and 12 months, measured as free-field hearing test Speech in quiet at 50, 65 and 80 dB SPL [% correctly perceived words at 50, 65 and 80 dB SPL] is presented. The change in percent points is presented. A positive value indicates an improved ability to perceive words in quiet at the specified decibel (dB) level a negative value represent an impairment.|Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.|Some of the subjects did not perform the test at one or more visits.|||Percentage of correctly perceived words||Standard Deviation|Mean
2539052|NCT03086135|Secondary|Hearing Performance: Threshold Audiometry Individual Frequences, Unaided Versus OSIA System at 4 Weeks, 3, 6 and 12 Months|The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA system at 4 weeks, 3, 6 and 12 months, measured as free-field hearing test: Threshold audiometry (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz) is presented. This value gives a snapshot of an individual's hearing level. If PTA is <25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of the unaided hearing level expressed in dB and the hearing level aided with the Osia system at different time points. An unaided value should be higher than a aided if the hearing device is effective. A lower or more negative score is therefor more desirable and reflects a better ability to hear at the specified frequency.|Baseline before surgery, 4 weeks, 3, 6 and 12 months after surgery.|750, 1500 and 8000 Hz were not included in the eCRF for free-field threshold audiometry test due to an error when the first six subjects entered the study. Measurements at these frequencies were therefore not performed at the first visits. In addition; not all subjects performed the test at all frequencies at all visits.|||dB (Decibel)||Standard Deviation|Mean
2539053|NCT03086135|Secondary|Hearing Performance: Threshold Audiometry, Pure Tone Average, PTA4, Unaided Versus OSIA System at 4 Weeks, 6 and 12 Months|The change of hearing performance from the unaided hearinhg situation before surgery to the aided hearing situation with the OSIA system at 4 weeks, 6 and 12 months, measured as free-field hearing test: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. A Pure Tone Average (PTA) refers to the average of hearing threshold levels at a set of specified frequencies: typically 500, 1000, 2000 and 4000 Hz. This value gives a snapshot of an individual's hearing level. If PTA is <25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of PTA4 unaided and PTA4 aided with the Osia system. An uaided PTA4 values should be higher than a aided PTA4 if the hearing device is effective. A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.|Baseline before surgery, 4 weeks, 6 and 12 months after surgery|Some subjects did not perform the test at one or more visits.|||dB||Standard Deviation|Mean
2539054|NCT03086135|Primary|Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 3 Months.|The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA System at 3 months measured as free field hearing test Adaptive speech recognition in noise, is presented. Adaptive speech recognition in noise was measured as Signal to Noise Ratio (SNR). The noise was kept constant at 65 dB SPL and the speech was adapted in dB steps to establish the Speech-to-Noise Ratio (SNR) providing a 50% level of understanding. A ratio of 0 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A negative SNR-value reflects the ability to correctly hear sentences below 65 dB, for example if 50% of the speech is received correctly at 55 dB the SNR value is -10. A positive SNR-value (Speech to Noise Ratio) reflects the ability to correctly hear sentences presented above 65 dB. A lower or more negative score is more desirable and reflects abetter hearing in a noisy enviroment.|Baseline before surgery, 3 months after surgery||||SNR (Speech in Noise Ratio)||Standard Deviation|Mean
2539055|NCT03086135|Primary|Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months|The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA system at 3 month, measured as free-field hearing test; Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. A Pure Tone Average (PTA) refers to the average of hearing threshold levels at a set of specified frequencies: typically 500, 1000, 2000 and 4000 Hz. This value gives a snapshot of an individual's hearing level. If PTA is <25 dB, the overall hearing would be considered to be within normal limits. With a PTA of 95 dB, the hearing would be considered in the profound range. The units reported for PTA4 are decibels (dB). The results presented here are the difference of PTA4 unaided and PTA4 aided with the Osia system. An uaided PTA4 values should be higher than a aided PTA4 if the hearing device is effective. A lower or more negative score is more desirable and reflects a better ability to hear softer sounds.|Baseline before surgery, 3 months after surgery||||dB (Decibel)||Standard Deviation|Mean
2539056|NCT03086018|Secondary|Events|Events will be measured by the reporting of unexpected sounds or behavior of the device through questionnaires, diaries, and interviews. The number of events reported including AEs related to the device will be used to measure the outcome. Less events is a better outcome.|A 2 hour period of interviews and questionnaires after having worn the devices for approximately 2 weeks and keeping a diary to make notes of device behavior.||||Units of AEs related to device|||Number
2539057|NCT03086018|Secondary|Handling/Usability Performance|"The usability of the new device will be measured with a 3-point rating scale used by the tester to evaluate tasks performed by the end user as well as questionnaires and interviews.~The questionnaire asks subjects to perform tasks, and the clinician rates the ease with which they complete the tasks. 2 is the highest score meaning that they could complete without help, 1 means that they required some assistance, and 0 means that they could not complete the task. A higher score means a better outcome."|2 hour period of usability testing with tasks and questionnaires.||||percentage of tasks scored with 2|||Number
2539264|NCT03077659|Secondary|Percentage of Sample Considered Adenocarcinoma|Tissues excised from the primary tumor during prostatectomy (Day 29) were evaluated for the percentage considered adenocarcinoma|Day 29 (prostatectomy)|Full Analysis Set|||percentage of sample adenocarcinoma||Standard Deviation|Mean
2539058|NCT03086018|Secondary|Speech Intelligibility Performance With New Feature|"Word recognition test scores will be measured with two signal-to-noise ratio (SNR) levels in percent correct in two conditions, with the new feature on and the new feature off.~The test is a speech test with the words stated in noise at either a 5 dB SNR or a 15 dB SNR. The subject is presented with 5 rhyming words and must choose which word they heard. It is a forced choice meaning that the test will not continue with the next word until they've made a selection. They cannot leave any blank and are not penalized for wrong answers. The score is a percentage of words correct with the maximum score being 100% and the minimum being 0%. A higher score means a better outcome."|2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.||||percent correct out of 100%||Standard Deviation|Mean
2539059|NCT03086018|Secondary|Subjective Performance of Aided Benefit|"The subjective performance for the new device will be measured with the APHAB questionnaire (Abbreviated Hearing Aid Benefit Profile). The questionnaire is a list of 24 statement that the subjects must agree or disagree with using a scale of units from A to G (A being Always and G being Never). Each letter has a corresponding score used for the calculation: A receives 99, B receives 87, C receives 75, D receives 50, E receives 25, F recevies 12, and G receives 1.~An average for each subscale is calculated, and a global or overall score can be calculated by taking the mean of the three positive subscales (Ease of communication, Background noise, and Reverberation). For these three subscales a higher score indicates a better performance. The highest possible score is 99 and the lowest is 1. The fourth scale (Aversiveness) is a negative scale meaning that a higher score means a worse performance. The highest possible score is 99 and the lowest is 1."|A 2 week time period during which they will wear the devices and answer questionnaires about the experience.|For this questionnaire, two participants had left the study and data was not collected.|||Units on a scale||Standard Deviation|Median
2539060|NCT03086018|Primary|Speech Intelligibility Performance|Speech test scores will be measured with speech reception thresholds (SRTs) of speech in noise in three conditions: unaided, aided with the current device, and aided with the new device. The score is measured by the the signal-to-noise ratio (SNR) at which 50% of words in a sentence list are correctly repeated. The speech is always presented at 65 dB and the background noise varies to maintain the 50% correct. A lower SNR score indicates a better score. The maximum score will be 15 dB and the minimum will be -5 dB.|2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.||||dB SNR||Standard Deviation|Mean
2539061|NCT03085836|Primary|CLR: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9||Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose|The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations. PK analysis population where data at specified time points were available.|||L/h||Standard Deviation|Mean
2539062|NCT03085836|Primary|Fe,τ: Fraction of Administered Dose of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9||Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose|The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.|||percentage of drug||Standard Deviation|Mean
2539063|NCT03085836|Primary|Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9||Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose|The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.|||mcg||Standard Deviation|Mean
2539064|NCT03085836|Primary|CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1||Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose|The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations. PK analysis population where data at specified time points were available.|||liter per hour (L/h)||Standard Deviation|Mean
2539065|NCT03085836|Primary|Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1||Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose|The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.|||percentage of drug||Standard Deviation|Mean
2539066|NCT03085836|Primary|Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1||Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose|The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.|||microgram (mcg)||Standard Deviation|Mean
2539067|NCT03085836|Primary|AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9||Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose|The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations. PK analysis population where data at specified time points were available.|||h*ng/mL||Standard Deviation|Mean
2539344|NCT03075449|Secondary|The Percentage of Men Who Received a Medical Diagnosis for Their Urinary Symptoms, as Recorded in Their Medical Records.|"The percentage of men who received a medical diagnosis for their urinary symptoms, as recorded in their medical records.~95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution."|12 months|FAS|||Percentage of participants||95% Confidence Interval|Number
2539068|NCT03085836|Primary|Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9||Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose|The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.|||hour||Full Range|Median
2539069|NCT03085836|Primary|Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9||Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose|The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.|||ng/mL||Standard Deviation|Mean
2539070|NCT03085836|Primary|T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1||Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose|The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations. PK analysis population where data at specified time points were available.|||hour||Standard Deviation|Mean
2539071|NCT03085836|Primary|AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1||Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose|The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.|||h*ng/mL||Standard Deviation|Mean
2539072|NCT03085836|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1||Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose|The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
2539073|NCT03085836|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1||Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose|The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.|||hour||Full Range|Median
2539074|NCT03085836|Primary|Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1||Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose|The PK set included all participants who received the study drug, had sufficient plasma/urine concentration data to calculate at least 1 PK parameter, and completed the minimum protocol specified procedures with no significant protocol deviations.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2539075|NCT03085238|Post-Hoc|Tumor Cell Infiltration|Estimate of tumor cell infiltration into the device based on histopathological analysis of devices from recurrent patients who underwent successful device removal. Percentage of device was determined by analysis of one slide from one tissue block (0.3 cm thick), by considering the amount of tumor cells in comparison to the total number of cells present in the slide when analyzed using image analysis with a digital slide scanner [Membrane Quant Module, Panoramic 250 FLASH II 2.0 (3D HISTEC)].|Time of recurrence, an average of 14.5 months|Recurrent patients who underwent successful device removal|||percentage of device||Standard Deviation|Mean
2539076|NCT03085238|Other Pre-specified|Number of Participants With Reasons for Device Removal|Reason that device removal was planned, regardless of whether or not it was completed.|Time of device removal, an average of 13.3 months|All enrolled patients|||Participants|||Count of Participants
2539077|NCT03085238|Other Pre-specified|Disease Focalization Score by Recurrence Status|Disease focalization score - Disease focalization scores of I, II, III, IV, or V were assigned by the evaluating clinician, representing the approximate percentage 100%, 75%, 50%, 25%, or 0%, respectively, of recurrent tumor contained in the M-Trap device|Time of recurrence, an average of 14.5 months|All patients with disease focalization scores reported|||Participants|||Count of Participants
2539078|NCT03085238|Other Pre-specified|Number of Devices Implanted|Number of devices implanted at conclusion of debulking surgery.|Immediately post-procedure|All patients|||Participants|||Count of Participants
2539079|NCT03085238|Secondary|Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status|Disease focalization score - Disease focalization scores of I, II, III, IV, or V were assigned by the evaluating clinician, representing the approximate percentage 100%, 75%, 50%, 25%, or 0%, respectively, of recurrent tumor contained in the M-Trap device. Results are presented as described in secondary objective: patient count of score I; score I or II; score I, II or III; score I, II, III or IV; or No focalization.|Time of recurrence, an average of 14.5 months|All patients with disease focalization scores reported|||Participants|||Count of Participants
2539080|NCT03085238|Secondary|Safety: Number of Participants With Procedure-related Long-term Adverse Event Reporting|Procedure-related long-term adverse events and serious adverse events reported through 18 months|18 months|All enrolled patients|||Participants|||Count of Participants
2539081|NCT03085238|Secondary|Safety: Number of Participants With Device-related Long-term Adverse Event Reporting|Device-related long-term adverse events and serious adverse events reported through 18 months|18 months|All enrolled patients|||Participants|||Count of Participants
2539082|NCT03085238|Primary|Performance: Number of Participants With Histological Evidence of Tumor Cell Capture|Histological evidence of tumor cell capture in at least one device in patients who underwent successful device removal|Time of device removal, an average of 13.3 months|Assessment was completed in all patients who underwent successful device removal.|||Participants|||Count of Participants
2539083|NCT03085238|Primary|Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events|An additional analysis was performed to assess safety of M-Trap in comparison to historical controls at a comparable 30 day timepoint, as measured by freedom from device- and procedure-related major adverse events through 30 days post-implantation. Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 30-days post-implantation, including shock, cardiac arrest, myocardial infarction, pulmonary embolism, prolonged intubation, unplanned reintubation, or adverse events leading to removal of the device, including infection, seroma formation, mesh migration, bowel obstruction, adhesions, and local cancer progression through the abdominal wall at M-Trap suture sites, adjusted based on the breakdown of the historical control population by number of extended procedures|30 days|All enrolled patients|||Participants|||Count of Participants
2539084|NCT03085238|Primary|Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events|The primary objective is to demonstrate that the safety of M-Trap, as measured by freedom from device- and procedure-related major adverse events through 6-months post-implantation, is non-inferior to historical controls (Patankar 2015). Freedom from device and procedure-related major adverse events is defined as severe complications based on Clavian Class IV complications, through 6-months post-implantation, including shock, cardiac arrest, myocardial infarction, pulmonary embolism, prolonged intubation, unplanned reintubation, or adverse events leading to removal of the device, including infection, seroma formation, mesh migration, bowel obstruction, adhesions, and local cancer progression through the abdominal wall at M-Trap suture sites.|6 months|All enrolled patients|||Participants|||Count of Participants
2539085|NCT03084315|Primary|Change in Biomarker Concentrations: NNAL|Change in urinary concentration of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) in units of pmol/mg creatinine.|Baseline, Week 24||||pmol/mg creatinine||Standard Deviation|Mean
2539086|NCT03084315|Primary|Change in Biomarker Concentrations: Nicotine Equivalents|Change in concentration of nicotine equivalents in units of mmol/mg creatinine.|Baseline, Week 24||||mmol/mg creatinine||Standard Deviation|Mean
2539087|NCT03083769|Primary|Number of Participants With Tacrolimus-related Neurotoxicities|We will measure the number of participants with tacrolimus-related neurotoxicities during the day 1 to day 61 after transplantation. Kaplan-Meier analyses were performed for tacrolimus-related neurotoxicities in participants with different genotypes.|Day1 to Day 61||||participants|||Number
2539088|NCT03083769|Primary|Number of Participants With Tacrolimus-related Nephrotoxicities|We will measure the number of participants with tacrolimus-related nephrotoxicities during the day 1 to day 61 after transplantation. Kaplan-Meier analyses were performed for tacrolimus-related nephrotoxicities in participants with different genotypes.|Day1 to Day 61||||participants|||Number
2539089|NCT03083769|Primary|Number of Participants With Acute Rejection|We will measure the number of participants with acute rejection during the day 1 to day 61 after transplantation. Kaplan-Meier analyses were performed for acute rejection in participants with different genotypes.|Day 1 to Day 61||||participants|||Number
2539090|NCT03083639|Primary|Cmax: Maximum Observed Plasma Concentration for Esomeprazole||Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose|The PK set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration of study drug. The PK set where data at specified timepoints was available for all participants who received at least one dose of Regimen A and Regimen B.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2539091|NCT03083639|Primary|AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for Esomeprazole||Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose|The PK set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration of study drug. The PK set where data at specified timepoints was available for all participants who received at least one dose of Regimen A and Regimen B.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2539092|NCT03083639|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Esomeprazole||Day 1 pre-dose and at multiple time points (up to 10 hours) post-dose|The pharmacokinetic (PK) set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration of study drug. The PK set where data at specified timepoints was available for all participants who received at least one dose of Regimen A and Regimen B.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2539093|NCT03083483|Secondary|Number of Errors|The number of errors (as defined by FLS) during completion of tasks will be recorded and transitioned into a time addition. This will be collected for every repetition performed during the 6 separate training sessions within a 7-day period. These errors will be defined and retrospective review of recorded video through study completion.|7 days|Participants who completed the study.|||errors||Standard Deviation|Mean
2539094|NCT03083483|Secondary|Number of Tasks Completed|The number of completed tasks will be calculated during retrospective review of recorded video through study completion. The six training sessions for data collection will be completed within a 7-day span.|7 days|In performing the study, only FLS task 1 was performed and evaluated. Therefore, no data was collected or analyzed on multiple tasks.||||||
2539095|NCT03083483|Primary|Time to Completion|Completion time for each repetition of Fundamentals of Laparoscopic Surgery (FLS) task 1 in post-test (1 single repetition of the task that was timed after all training was completed)|7 days|Participants who completed the study.|||seconds to completion in post test||Standard Deviation|Mean
2539096|NCT03083470|Secondary|Percent Change in Size of AK Lesions|Percent change in size of AK lesions was determined with measurements obtained at Baseline and 56 days. A measurement was also obtained at Day 28, but was not used to calculated percent change for the purposes of this outcome measure.|Baseline and 56 days|Two subjects, both receiving Vehicle, were withdrawn early from the study; one of these subjects participated long enough to be included in the analysis of the efficacy endpoint and one did not. Therefore, there are 8 subjects in the Ointment Vehicle arm of the study.|||Percent Change||Standard Deviation|Mean
2539413|NCT03073876|Primary|Instrumental Activities of Daily Living|Scale of instrumental activities of daily living (IADLs), adapted from Lawton Brody scale. Caregiver rates 8 functional items from 0-2 severity. Total score is the sum of ratings for each item. Total score ranges from 0 (minimum) to 16 (maximum) with higher scores representing worse functional outcomes.|6 months||||units on a scale||Standard Deviation|Mean
2539097|NCT03083470|Secondary|Percent Change in Number of AK Lesions|AK lesions in the target test field were photographed and tracings were created at baseline and at subsequent visits to track whether lesions were clear or still present.|Baseline and 56 days|Two subjects, both receiving Vehicle, were withdrawn early from the study; one of these subjects participated long enough to be included in the analysis of the efficacy endpoint and one did not. Therefore, there are 8 subjects in the Ointment Vehicle arm of the study.|||Percent Change||Standard Deviation|Mean
2539098|NCT03083470|Secondary|Pharmacokinetics: Time at Which Peak Plasma Concentration is Observed (Tmax) of SOR007|Pharmacokinetic (PK) samples were taken on Day 1 at 1h, 2h, 4h, and 6h post application; on Day 8, Day 15, and Day 21 after the first daily application; and on Day 28 at 1h, 2h, 4h, 6h, and 12h after the first daily application.|28 days||||hr||Standard Deviation|Mean
2539099|NCT03083470|Secondary|Pharmacokinetics: Peak Plasma Concentration (Cmax) of SOR007|Pharmacokinetic (PK) samples were taken on Day 1 at 1h, 2h, 4h, and 6h post application; on Day 8, Day 15, and Day 21 after the first daily application; and on Day 28 at 1h, 2h, 4h, 6h, and 12h after the first daily application.|28 days||||pg/mL||Standard Deviation|Mean
2539100|NCT03083470|Secondary|Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of SOR007|Pharmacokinetic (PK) samples were taken on Day 1 at 1h, 2h, 4h, and 6h post application; on Day 8, Day 15, and Day 21 after the first daily application; and on Day 28 at 1h, 2h, 4h, 6h, and 12h after the first daily application.|28 days||||pg·hr/mL||Standard Deviation|Mean
2539101|NCT03083470|Primary|Number of Participants With Treatment Emergent Adverse Events|Treatment emergent adverse events including all reported adverse events, laboratory assessments, physical examination findings, and vital signs.|56 days||||Participants|||Count of Participants
2539102|NCT03083379|Primary|Regional Distribution of Ventilation|EIT will be used to measure change in regional distribution of ventilation during lung expansion therapy.|2 months||||percentage of dorsal redistribution||Inter-Quartile Range|Median
2539103|NCT03082599|Other Pre-specified|Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Accuracy to Target ≤ 0.5D||3 months|One subject in the emmetropia group missed the Month 3 visit.|||percentage of eyes|Eyes||Number
2539104|NCT03082599|Other Pre-specified|Residual Refractive Cylinder||3 months|One subject in the emmetropia group missed the Month 3 visit.|||diopters||Standard Deviation|Mean
2539105|NCT03082599|Other Pre-specified|Residual Refractive Sphere||3 months|One subject in the emmetropia group missed the Month 3 visit.|||diopters||Standard Deviation|Mean
2539106|NCT03082599|Other Pre-specified|Residual Mean Spherical Equivalent Refraction||3 months|One subject in the emmetropia group missed the Month 3 visit.|||diopters||Standard Deviation|Mean
2539107|NCT03082599|Secondary|Patient Reported Spectacle Independence Questionnaire|Percentage of participants who reported wearing glasses none or a little of the time in the self administered questionnaire.|3 months|One subject in the emmetropia group missed the Month 3 visit.|||percentage of participants|||Number
2539108|NCT03082599|Secondary|Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ)|Percentage of patients who reported any visual symptoms such as halos, glare, starburst, light sensitivity when answering the self administered questionnaire.|3 months|One subject in the emmetropia group missed the Month 3 visit.|||percentage of participants|||Number
2539109|NCT03082599|Secondary|Uncorrected (4 m) Visual Acuity|Visual acuity without correction (no glasses) measured at 4 m.|3 months|One subject in the emmetropia group missed the Month 3 visit.|||diopters||Standard Deviation|Mean
2539110|NCT03082599|Secondary|Uncorrected Intermediate (66 cm) Visual Acuity|Visual acuity without correction (no glasses) measured at 66 cm.|3 months|One subject in the emmetropia group missed the Month 3 visit.|||diopters||Standard Deviation|Mean
2539111|NCT03082599|Secondary|Uncorrected Near (40 cm) Visual Acuity|Visual acuity without correction (no glasses) measured at 40 cm.|3 months|One subject in the emmetropia group missed the Month 3 visit.|||diopters||Standard Deviation|Mean
2539112|NCT03082599|Primary|Reduction of Manifest Cylinder (Diopters).||3 months|One subject in the emmetropia group missed the Month 3 visit.|||diopters||Standard Deviation|Mean
2539113|NCT03082599|Primary|Binocular Distance-corrected Near (40 cm) Visual Acuity.|Visual acuity with correction (glasses) measured at 40 cm.|3 months|One subject in the emmetropia group missed the Month 3 visit.|||diopters||Standard Deviation|Mean
2539114|NCT03080961|Secondary|ADE Description|Nature and frequency of (possible) device related adverse events.|1-33 days|AT Population that applied VIBLOK at least once.|||Count of participants per ADE type|||Number
2539115|NCT03080961|Secondary|HSV-2 Copy Number in AT Population|Change in HSV-2 copy number on days with asymptomatic shedding after applying VIBLOK.|26-32 days|A total of 25 out of 46 subjects in the AT population had days with asymptomatic HSV shedding.|||HSV copy number||95% Confidence Interval|Mean
2539116|NCT03080961|Secondary|HSV-2 Detection Rate in AT Population|Change in HSV-2 detection rate on days with asymptomatic shedding after applying VIBLOK.|26-32 days|45 subjects that returned swabs before and after VIBLOK application.|||Mean number of swabs with shedding||95% Confidence Interval|Mean
2539117|NCT03080961|Primary|Serious Adverse Device Effects|Percentage SADE's in the as treated population.|26-32 days|46 eligible subjects that applied VIBLOK for an average of 27.2 days.|||Percentage SADE's||95% Confidence Interval|Number
2539118|NCT03080493|Secondary|Number of Participants Using Narcotic Pain Medication (Acetaminophen/Codeine)|Subject account of how many used acetaminophen/codeine (standard medications given for supplement NSAID as needed after dilator insertion)|Collected between each subject contact (2 hours, 4 hours, 8 hours after dilator insertion and at time of presentation for D&E procedure)|Any use of narcotics|||Participants|||Count of Participants
2539119|NCT03080493|Secondary|Mean Change From Baseline in NRS Pain Score at Time of Presentation for D&E Procedure (Day Following Dilator Insertion)|Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained in person upon presentation for D&E procedure.|Time of presentation for D&E (day after dilator insertion)|Women who provided numeric pain scale scores|||Numeric rating scale pain score change||Full Range|Median
2539493|NCT03070730|Secondary|Change in Physical Functioning-CIS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Checklist Individual Strength (CIS).|1 week after first intervention|||||||
2539120|NCT03080493|Secondary|Mean Change From Baseline in NRS Pain Score at 4 Hours After Dilator Insertion|Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.|4 hours after insertion of last osmotic dilator|Women who responded by text with numeric pain scale score|||Numeric rating scale pain score change||Full Range|Mean
2539121|NCT03080493|Secondary|Mean Change From Baseline in NRS Pain Score at 2 Hours After Dilator Insertion|Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.|2 hours after insertion of last osmotic dilator|Women who responded by text with numeric pain scale score|||Numeric rating scale pain score change||Full Range|Median
2539122|NCT03080493|Secondary|Mean Change From Baseline in NRS Pain Score at 5 Minutes After Last Dilator Insertion|Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained in person before subject leaves clinic appointment.|5 minutes after insertion of last osmotic dilator|Women who provided Numeric rating scale pain score|||Numeric rating scale pain score change||Full Range|Median
2539123|NCT03080493|Primary|Mean Change From Baseline in NRS Pain Score at 8 Hours After Dilator Insertion|Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.|8 hours after insertion of last osmotic dilator|Women who responded with pain scores by text using Numeric Rating Scale|||Numeric rating scale pain score change||Full Range|Median
2539124|NCT03080454|Secondary|Mean Modified Tardieu Scale (MTS) Score|The Modified Tardieu Scale (MTS) quantifies muscle spasticity for each joint at slow and fast velocities on a 0-5 point scale. MTS scores at fast velocity were summed across 11 joints of the upper extremity (for a total of 0-55 points), with lower scores indicating improved spasticity. Mean summed MTS scores (out of 55 total points) were compared across two timepoints (final session at day 5 and 1 week FU) in two conditions (sham vs. anodal Doublestim).|baseline, final session at day 5, 1 week FU|Three subjects (out of 19) were found to be significant outliers for normality testing, and were consequently removed from analysis.|||scores on a scale||Standard Error|Least Squares Mean
2539125|NCT03080454|Primary|Mean Percent Change From Baseline in Area Under the Curve for Objectively Measured Spastic Catch Response of the Wrist Flexors at Fast Speed|Subjects' wrists were passively extended at fast speed by a stepper motor to induce a spastic catch response, and its resistance torque was calculated in Newton meters (Nm). Mean percent change from baseline in the area under the curve for the resistance torque were compared across two timepoints (final session at day 5 and 1 week follow-up) in two conditions (sham vs. anodal Doublestim)|baseline, final session at day 5, 1 week FU|Three subjects (out of 19) were found to be significant outliers for normality testing, and were consequently removed from analysis.|||percent change||Standard Error|Least Squares Mean
2539126|NCT03079531|Secondary|Change From Baseline in Immune Infiltrates in Papulopustular Rosacea Lesions at Week 16|Immune infiltrates as assessed by immunohistochemistry, using a semi-quantitative grading scale for histological inflammation (scale range: 0-4, with 0-normal to 4-widespread inflammation).|Baseline, week 16|Participants who contributed skin biopsies at both week 0 and week 16 are included in the analysis.|||score on a scale||Inter-Quartile Range|Median
2539127|NCT03079531|Secondary|Count of Participants With ≥ Grade 3 Adverse Events||16 weeks||||Participants|||Count of Participants
2539128|NCT03079531|Secondary|Change From Baseline in Rosacea Quality of Life (RosaQoL) Score at Week 16|Scale range: 0-5 with greater scores denoting worse quality of life.|Baseline, week 16|Participants who completed through week 16 are included in the analysis.|||score on a scale||Inter-Quartile Range|Median
2539129|NCT03079531|Secondary|Change From Baseline in Clinician's Global Erythema Assessment Score at Week 16|Scale range: 0-4 (0=none; 1=mild; 2=moderate; 3=significant; 4=severe).|Baseline, week 16|Participants who completed through week 16 are included in the analysis.|||score on a scale||Inter-Quartile Range|Median
2539130|NCT03079531|Secondary|Change From Baseline in Clinician's Global Severity Score for Rosacea at Week 16|Scale range: 0-4 (0=none to very mild; 1=mild; 2=moderate; 3=severe; 4=very severe).|Baseline, week 16|Participants who completed through week 16 are included in the analysis.|||score on a scale||Inter-Quartile Range|Median
2539131|NCT03079531|Secondary|Change From Baseline Papule/Pustule Count at Week 12|The total number of papules and pustules on the patient was assessed.|Baseline, week 12|Participants who completed through week 12 are included in the analysis.|||papules and pustules||Inter-Quartile Range|Median
2539132|NCT03079531|Primary|Change From Baseline in Papule/Pustule Count at Week 16|The total number of papules and pustules on the patient was assessed.|Baseline, week 16|Participants who completed through week 16 are included in the analysis.|||papules and pustules||Inter-Quartile Range|Median
2539133|NCT03079375|Secondary|Drug Related Mortality|number of patients who have drug related death|180 days after the inclusion date||||Participants|||Count of Participants
2539134|NCT03079375|Secondary|Mortality|number of patient who died within 6 month after inclusion|180 days after the inclusion date||||Participants|||Count of Participants
2539135|NCT03079375|Secondary|Medication Review Changes Accepted by Physicians (in Hospital)|Medication review data were not collected from the Usual care Group and were collected only for the Basic and Extended Groups.|1 month|Medication review data were not collected from the Usual care Group and were collected only for the Basic and Extended Groups. The acceptance rate is only analyzed for of the basic intervention and the extended intervention in total.|||percentage of medication changes|||Number
2539136|NCT03079375|Secondary|Percentage of Medication Changes Accepted by GPs|Acceptance rate in primary care (general practitioner). Medication review data were not collected from the Usual care Group and were collected only for the Basic and Extended Groups.|up to 180 days|Medication review data were not collected from the Usual care Group and were collected only for the Basic and Extended Groups. No interventions were sent to the general practitioner for the Usual care and the Basic intervention Groups.|||percentage of medication changes|||Number
2539143|NCT03078647|Secondary|Subject Satisfaction and Improvement - by Questionnaire|"Evaluate subject satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction and improvement scale [(-2) Very dissatisfied, (-1) Dissatisfied, (0) No opinion, (1) Satisfied, (2) Very satisfied].~The analysis quantify subject satisfaction (grades 1-2)"|1, 3, and 6 months post-treatment visit|"Suprapatellar areas- 17 subjects, 8 subjects (16 areas) had one assessment for both sides treated with the same parameters.~Upper Arms- 10 Subjects had one assessment for both sides treated with same parameters (1 subject dropped after 1 wk FU).~Braline areas- 3 subjects, one subject had one assessment for both sides treated with same parameters"|||Subject Assessments|Subject Assessments||Count of Units
2539144|NCT03078647|Secondary|Investigator Satisfaction - by Questionnaire|"Evaluate Investigator satisfaction at 1, 3, and 6 months post-treatment visit, using a satisfaction scale [(-2) Very dissatisfied, (-1) Dissatisfied, (0) No opinion, (1) Satisfied, (2) Very satisfied].~The analysis quantify investigator satisfaction (grades 1-2)"|1, 3, and 6 months post-treatment visit|"Suprapatellar areas- 17 subjects, 8 subjects (16 areas) had one assessment for both sides treated with the same parameters.~Upper Arms- 10 Subjects had one assessment for both sides treated with same parameters (1 subject dropped after 1 wk FU).~Braline areas- 3 subjects, one subject had one assessment for both sides treated with same parameters"|||Investigator Assessments|Investigator Assessments||Count of Units
2539145|NCT03078647|Secondary|Improvement in Skin Tightening/Laxity in Treated Areas, as Assessed by Study Investigator Evaluations|"Evaluate the improvement in skin tightening in treated areas following a single dermal and/or subcutaneous treatment with Profound, as assessed by study investigators at 1 and 6 months post treatment visit. Investigators used the following scale: (0) No tightening/firmness; (1) Slightly visible tightening/firmness; (2) Visible tightening/firmness; (3) Very visible tightening/firmness.~The analysis calculates the skin tightening improvement graded: (2) Visible tightening/firmness and (3) Very visible tightening/firmness"|1, 3 and 6 months post treatment visit.|"Suprapatellar areas- 17 subjects, 8 subjects (16 areas) had one assessment for both sides treated with the same parameters.~Upper Arms- 10 Subjects had one assessment for both sides treated with same parameters (1 subject dropped after 1 wk FU).~Braline areas- 3 subjects, one subject had one assessment for both sides treated with same parameters"|||Investigator Assessments|Investigator Assessments||Count of Units
2539146|NCT03078647|Primary|Improvement in Global Aesthetic Appearance of Cellulite in Treated Areas, as Assessed by Study Investigator Evaluations|"Evaluate the improvement in global aesthetic appearance of cellulite in treated areas following a single dermal and/or subcutaneous treatment with Profound, as assessed by study investigators at 1,3 and 6 months post treatment visit. Investigators used the following scale: 0=No Change; 1= 1-24% improvement; 2=25-49% improvement; 3=50-74% improvement; 4=75-100% improvement.~The analysis calculates the improvement over 25% (grades 2-4)"|1,3 and 6 months post-treatment|"Suprapatellar areas- 17 subjects, 8 subjects (16 areas) had one assessment for both sides treated with the same parameters.~Upper Arms- 10 Subjects had one assessment for both sides treated with same parameters (1 subject dropped after 1 wk FU).~Braline areas- 3 subjects, one subject had one assessment for both sides treated with same parameters"|||Investigator Assessments|Investigator Assessments||Count of Units
2539147|NCT03078595|Secondary|Gingival Bleeding Index (GBI)|A periodontal probe is gently moved through the gingival sulcus. Bleeding is assessed at 6 sites per tooth (mesio-buccal, buccal, disto-buccal, disto-oral, oral, mesio-oral). The frequency of bleeding sites of the total number of assessed sites is calculated as index.|cross-sectional: only one assessment at the time of examination||||percentage of sites||Standard Deviation|Mean
2539148|NCT03078595|Primary|Bleeding on Probing (BOP)|Using a periodontal probe probing pocket depths (PPD) are assessed with a force of 0.2 N at 6 sites per tooth (mesio-buccal, buccal, disto-buccal, disto-oral, oral, mesio-oral). After 30 seconds bleeding on probing is scored at each site. The frequency of bleeding sites of the total number of assessed sites is calculated as index.|cross-sectional: only one assessment at the time of examination||||percentage of sites||Standard Deviation|Mean
2539149|NCT03078582|Secondary|Hemoglobinuria Values|Changes from baseline at each of the scheduled post-baseline time-points; Hemoglobinuria was assessed using a urine colorimetric scoring system with a score of 1 through 10. Where 1 represents no hemoglobinuria and 10 represents maximum hemoglobinuria.|Through Week 12 of the Study|Efficacy Evaluable|||score on a scale||Standard Deviation|Mean
2539150|NCT03078582|Secondary|Reticulocyte Values|Changes from baseline at each of the scheduled post-baseline time-points|Through Week 12 of the Study|Efficacy Evaluable|||10^12 cells/L (SI Units)||Standard Deviation|Mean
2539151|NCT03078582|Secondary|Haptoglobin Values|Changes from baseline at each of the scheduled post-baseline time-points|Through Week 12 of the Study|Efficacy Evaluable|||g/L||Standard Deviation|Mean
2539152|NCT03078582|Secondary|Changes From Baseline in Free Hemoglobin Values|Changes from baseline at each of the scheduled post-baseline time-points|Through Week 12 of the study|Efficacy Evaluable|||mg/dL||Standard Deviation|Mean
2539153|NCT03078582|Secondary|Total Hemoglobin|Changes from baseline at each of the scheduled post-baseline time-points|Through Week 12 of the Study|Efficacy Evaluable|||g/L||Standard Deviation|Mean
2539154|NCT03078582|Secondary|Changes From Baseline in Bilirubin Values|Changes from baseline at each of the scheduled post-baseline time-points|Through Week 12 of the study|Efficacy Evaluable|||umol/L||Standard Deviation|Mean
2539155|NCT03078582|Primary|Change-from-baseline in Serum Lactate Dehydrogenase (LDH) Level.|The primary efficacy endpoint is the change-from-baseline in serum LDH levels during this period, defined as the mean LDH values of Weeks 6, 8, 10, and 12 minus the baseline value of LDH.|Through Week 12 of the study|Efficacy Evaluable|||U/L||Standard Deviation|Mean
2539156|NCT03078556|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Participants having any AE or SAE are presented.|Up to Week 11|Safety Population.|||Participants|||Count of Participants
2539494|NCT03070730|Secondary|Change in Physical Functioning- HADS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Hospital Anxiety and Depression Scales.|1 week after third intervention|||||||
2539157|NCT03078556|Secondary|Change From Baseline in Heart Rate (HR): Part 1 and 2|HR was measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for HR for Part 1 and 2 is presented.|Up to Day 31 in Part 1 and Part 2|Safety Population. Only those participants available at the specified time points were analyzed represented by n=X,X,X,X,X,X in the category titles.|||Beats per minute||Standard Deviation|Mean
2539158|NCT03078556|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2|SBP and DBP were measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for SBP and DBP for Part 1 and 2 is presented.|Up to Day 31 in Part 1 and Part 2|Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug. Only those participants available at the specified time points were analyzed represented by n=X,X,X,X,X,X in the category titles.|||Millimeters of mercury||Standard Deviation|Mean
2539159|NCT03078556|Secondary|C24 of DTG and 3TC in the Fed State: Part 2|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539160|NCT03078556|Secondary|C24 of DTG and 3TC in the Fed State: Part 1|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539161|NCT03078556|Secondary|Vz/F of DTG and 3TC in the Fed State: Part 2|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Liters||Geometric Coefficient of Variation|Geometric Mean
2539162|NCT03078556|Secondary|Vz/F of DTG and 3TC in the Fed State: Part 1|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2539163|NCT03078556|Secondary|Tlast of DTG and 3TC in the Fed State: Part 2|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Hours||Full Range|Median
2539164|NCT03078556|Secondary|Tlast of DTG and 3TC in the Fed State: Part 1|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Hours||Full Range|Median
2539165|NCT03078556|Secondary|CL/F of DTG and 3TC in the Fed State: Part 2|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2539166|NCT03078556|Secondary|CL/F of DTG and 3TC in the Fed State: Part 1|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2539167|NCT03078556|Secondary|AUC(0-24) of DTG and 3TC in the Fed State: Part 2|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Hour*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539415|NCT03073876|Secondary|Change in Visual Form Discrimination|Measure of visuospatial function requiring matching designs from the Benton Visual Form Discrimination test. Total scores is calculated by adding the number of items correct. Total score ranges from 0-32, higher score is better.|Baseline to 6 weeks||||score on a scale||Standard Deviation|Mean
2539168|NCT03078556|Secondary|AUC(0-24) of DTG and 3TC in the Fed State: Part 1|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Hour*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539169|NCT03078556|Secondary|Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 2|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Percentage of AUC||Full Range|Median
2539170|NCT03078556|Secondary|Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 1|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Percentage of AUC||Full Range|Median
2539171|NCT03078556|Secondary|Clast of DTG and 3TC in in the Fed State: Part 2|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Micrograms per milliliter||Full Range|Median
2539172|NCT03078556|Secondary|Clast of DTG and 3TC in in the Fed State: Part 1|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Micrograms per milliliter||Full Range|Median
2539173|NCT03078556|Secondary|Lambda z of DTG and 3TC in in the Fed State: Part 2|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Per hour||Full Range|Median
2539174|NCT03078556|Secondary|Lambda z of DTG and 3TC in in the Fed State: Part 1|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Per hour||Full Range|Median
2539175|NCT03078556|Secondary|T1/2 of DTG and 3TC in the Fed State: Part 2|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Hour||Full Range|Median
2539176|NCT03078556|Secondary|T1/2 of DTG and 3TC in the Fed State: Part 1|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Hour||Full Range|Median
2539177|NCT03078556|Secondary|Tmax of DTG and 3TC in the Fed State: Part 2|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Hour||Full Range|Median
2539178|NCT03078556|Secondary|Tmax of DTG and 3TC in the Fed State: Part 1|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Hour||Full Range|Median
2539179|NCT03078556|Secondary|Tlag of DTG and 3TC in Fed State: Part 2|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Hour||Full Range|Median
2539180|NCT03078556|Secondary|Tlag of DTG and 3TC in Fed State: Part 1|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Hour||Full Range|Median
2539181|NCT03078556|Secondary|Cmax of Plasma DTG and 3TC in the Fed State: Part 2|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539182|NCT03078556|Secondary|Cmax of Plasma DTG and 3TC in the Fed State: Part 1|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539183|NCT03078556|Secondary|AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 2|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Hour*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539184|NCT03078556|Secondary|AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 1|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Hour*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539185|NCT03078556|Secondary|AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 2|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter FD Summary Population|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539186|NCT03078556|Secondary|AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 1|Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter food effect (FD) Summary Population comprised of participants who participated in the food effect part of the study and had evaluable PK parameters for both fed and fasted administration of the FDC tablet formulation.|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539187|NCT03078556|Secondary|Clast of DTG and 3TC in the Fasted State: Part 2|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539188|NCT03078556|Secondary|Last Quantifiable Concentration (Clast) of DTG and 3TC in the Fasted State: Part 1|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539189|NCT03078556|Secondary|C24 of DTG and 3TC in the Fasted State: Part 2|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539441|NCT03073200|Secondary|Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss)|Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss).|Week 12|All randomized participants in Ixekizumab arm with week 12 PK samples.|||microgram per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2539190|NCT03078556|Secondary|Concentration at 24 Hours Post-dose (C24) of DTG and 3TC in the Fasted State: Part 1|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population.|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539191|NCT03078556|Secondary|Vz/F of DTG and 3TC in the Fasted State: Part 2|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed, represented by n= X,X in the category titles.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2539192|NCT03078556|Secondary|Apparent Oral Volume of Distribution (Vz/F) of DTG and 3TC in the Fasted State: Part 1|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population|||Liters||Geometric Coefficient of Variation|Geometric Mean
2539193|NCT03078556|Secondary|CL/F of DTG and 3TC in the Fasted State: Part 2|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed represented by n=X in the category titles.|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2539194|NCT03078556|Secondary|Apparent Oral Clearance (CL/F) of DTG and 3TC in the Fasted State: Part 1|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2539195|NCT03078556|Secondary|AUC(0-24) of DTG and 3TC in the Fasted State: Part 2|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539196|NCT03078556|Secondary|AUC of 0 to 24 Hours (AUC[0-24]) of DTG and 3TC in the Fasted State: Part 1|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population|||Hours*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539197|NCT03078556|Secondary|Percentage of Extrapolated AUC(0 to Inf) of DTG and 3TC in the Fasted State: Part 2|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed indicated by n=X in category titles.|||Percentage of AUC||Full Range|Median
2539198|NCT03078556|Secondary|Percentage of Extrapolated AUC (0 to Inf) of DTG and 3TC in the Fasted State: Part 1|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population.|||Percentage of AUC||Full Range|Median
2539442|NCT03073200|Secondary|Number of Participants With Anti-Ixekizumab Antibodies|Number of participants with anti-ixekizumab antibodies|Baseline through Week 48|||||||
2539199|NCT03078556|Secondary|Lambda z of DTG and 3TC in in the Fasted State: Part 2|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed (represented by n= X,X in the category titles).|||Per hour||Full Range|Median
2539200|NCT03078556|Secondary|Apparent Elimination Rate Constant (Lambda z) of DTG and 3TC in the Fasted State: Part 1|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population|||Per hour||Full Range|Median
2539201|NCT03078556|Secondary|t1/2 of DTG and 3TC in the Fasted State: Part 2|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed indicated by n=X in category titles.|||Hour||Full Range|Median
2539202|NCT03078556|Secondary|Time to Reach Half the Maximum Plasma Concentration (t1/2) of DTG and 3TC in the Fasted State: Part 1|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population|||Hour||Full Range|Median
2539203|NCT03078556|Secondary|Tlast of DTG and 3TC in the Fasted State: Part 2|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population|||Hour||Full Range|Median
2539204|NCT03078556|Secondary|Time of the Last Quantifiable Concentration (Tlast) of DTG and 3TC in the Fasted State: Part 1|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population|||Hour||Full Range|Median
2539205|NCT03078556|Secondary|Tmax of DTG and 3TC in the Fasted State: Part 2|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population|||Hour||Full Range|Median
2539206|NCT03078556|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of DTG and 3TC in the Fasted State: Part 1|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population.|||Hour||Full Range|Median
2539207|NCT03078556|Secondary|Tlag of DTG and 3TC in Fasted State: Part 2|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population|||Hour||Full Range|Median
2539208|NCT03078556|Secondary|Absorption Lag Time (Tlag) of DTG and 3TC in Fasted State: Part 1|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population|||Hour||Full Range|Median
2539209|NCT03078556|Primary|Cmax of Plasma DTG and 3TC in the Fasted State: Part 2|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539210|NCT03078556|Primary|Maximum Observed Concentration (Cmax) of Plasma DTG and 3TC in the Fasted State: Part 1|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539211|NCT03078556|Primary|AUC(0-t) of Plasma DTG and 3TC in the Fasted State: Part 2|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population|||Hour*microgram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2539212|NCT03078556|Primary|Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Time Point (AUC[0-t]) of Plasma DTG and 3TC in the Fasted State: Part 1|Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population.|||Hours*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539213|NCT03078556|Primary|AUC (0-Inf) of Plasma DTG and 3TC in the Fasted State: Part 2|Blood samples were collected at given time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted conditions in Periods 1 and 2 of Part 2.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed, represented by n= X,X in the category titles.|||Hours*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539214|NCT03078556|Primary|Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity [AUC (0-Inf)] of Plasma DTG and 3TC in the Fasted State: Part 1|Blood samples were collected at indicated time points to study the pharmacokinetic (PK) profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.|Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose|PK Parameter Bioequivalence (BE) Summary Population comprised of all participants who have evaluable PK parameters for both analytes and for both Period 1 and Period 2.|||Hour*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539215|NCT03078504|Primary|Blood Pressure Change|Change in mean arterial pressure from period 1 to period 2|10 minutes||||mmHg||Standard Deviation|Mean
2539216|NCT03078478|Secondary|Change in Body Weight From Baseline to End of Treatment (up to 88 Weeks)|Change in body weight, measured in kilograms, from baseline (week 0) to end of treatment (week 88).|Week 0, week 88|The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. Number Analyzed = number of participants with available data.|||kg||Standard Deviation|Mean
2539217|NCT03078478|Secondary|Number of Adverse Events From Randomisation to End of Maintenance Period 2 (up to 88 Weeks)|The adverse events presented are treatment emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment. Number of adverse events expressed in rates, from randomisation to end of maintenance period 2 (up to 88 weeks) is presented. Rate = number of events divided by patient years of exposure multiplied by 100.|88 weeks|The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator.|||Episodes/(PYE*100)|||Number
2539218|NCT03078478|Secondary|Number of Severe Hypoglycaemic Episodes During Treatment (up to 88 Weeks)|Severe hypoglycaemia are those episodes positively adjudicated by the event adjudication committee according to the ADA definition of a severe hypoglycaemic episode. This was evaluated for the total trial period (88 weeks). The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.|88 weeks|The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator.|||Episodes/(PYE*100)|||Number
2547894|NCT02896595|Secondary|Anesthetic Requirements|average end tidal volatile anesthetics Measured as intra operative anesthetic (MAC)|Up to 270 minutes||||Minimum Alveolar Concentration (MAC)||Standard Error|Mean
2539219|NCT03078478|Secondary|Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks)|Nocturnal severe or BG confirmed symptomatic hypoglycaemia was evaluated at the end of trial (88 weeks). The nocturnal period defined as the period between 00:01 and 05:59 a.m. (both inclusive). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.|88 weeks|The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator.|||Episodes/(PYE*100)|||Number
2539220|NCT03078478|Secondary|Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks)|Severe or BG confirmed symptomatic hypoglycaemia was evaluated during treatment (up to 88 weeks). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.|88 weeks|The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator.|||Episodes/(PYE*100)|||Number
2539221|NCT03078478|Secondary|Change in Mean Pre-breakfast Self-measured Plasma Glucose Used for Titration From Baseline to End of Treatment (up to 88 Weeks)|Participants measured their pre-breakfast self-measured plasma glucose (SMPG) value until end of treatment (week 88). Mean pre-breakfast self-measured plasma glucose used for titration at baseline and end of treatment (up to 88 weeks) are presented.|Week 0, week 88|Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2539222|NCT03078478|Secondary|Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no)|Participants achieving target HbA1c of less than 7.0% at the end of treatment (88 weeks) without nocturnal severe or BG-confirmed hypoglycaemia during maintenance 2 (36 weeks).|At 88 weeks|Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data.|||Percentage of participants|||Number
2539223|NCT03078478|Secondary|Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no)|Participants achieving target HbA1c of less than 7.0% at the end of treatment (88 weeks) without severe or BG-confirmed hypoglycaemia during maintenance 2 (36 weeks).|End of Treatment (up to 88 Weeks)|Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data.|||Percentage of participants|||Number
2539224|NCT03078478|Secondary|Percentage of Participants With FPG ≤ 5.0 mmol/L (90 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no)|Participants achieving a fasting plasma glucose value of less than or equal to 5.0 mmol/L (90 mg/dL) at end of treatment (up to 88 weeks).|At 88 weeks|Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data.|||Percentage of participants|||Number
2539225|NCT03078478|Secondary|Percentage of Participants With FPG ≤ 7.2 mmol/L (130 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no)|Participants achieving a fasting plasma glucose value of less than or equal to 7.2 mmol/L (130 mg/dL) at end of treatment (up to 88 weeks).|At 88 weeks|Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data.|||Percentage of participants|||Number
2539226|NCT03078478|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to End of Treatment (up to 88 Weeks)|Change in fasting plasma glucose (FPG) was evaluated from baseline to end of treatment period (week 88).|Week 0, week 88|Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data.|||mg/dL||Standard Deviation|Mean
2539227|NCT03078478|Secondary|Change in HbA1c From Baseline to End of Treatment (up to 88 Weeks)|Change in glycosylated haemoglobin (HbA1c) was evaluated from baseline to end of treatment period (week 88).|Week 0, week 88|The full analysis set (FAS) comprised all randomised subjects. Number Analyzed = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2539228|NCT03078478|Secondary|Number of Severe Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)|Severe hypoglycaemia are those episodes positively adjudicated by the event adjudication committee according to the ADA definition of a severe hypoglycaemic episode. This was evaluated for maintenance 2 period. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.|36 weeks (maintenance 2)|The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. Number Analyzed = number of participants with available data.|||Episodes/(PYE*100)|||Number
2539229|NCT03078478|Secondary|Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)|Nocturnal severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks). The nocturnal period defined as the period between 00:01 and 05:59 a.m. (both inclusive). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.|36 weeks|The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. Number Analyzed = number of participants with available data.|||Episodes/(PYE*100)|||Number
2539230|NCT03078478|Secondary|Basal Insulin Dose (U) at End of Treatment (up to 88 Weeks)|The observed mean daily basal insulin doses was evaluated at the end of trial (88 weeks).|88 weeks|The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. Number Analyzed = number of participants with available data.|||Units||Standard Deviation|Mean
2539231|NCT03078478|Primary|Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)|Severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks) period. Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.|36 Weeks|The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator.|||Episodes/(PYE*100)|||Number
2539232|NCT03078270|Primary|Efficacy of of Botulinum Toxin A Reducing Symptoms of Social Anxiety Disorder|Repeated measure at baseline, 4-weeks and 8-weeks post-injection of anxiety using the Liebowitz Social Anxiety Scale to determine treatment response.|2 months|The study was closed before outcome measures were collected.||||||
2539233|NCT03078127|Secondary|Purine Analysis (Hypoxanthine) in Exhaled Breath Condensate|Difference of concentration of hypoxanthine (a purine) in Exhaled Breath Condensate between post-ACT and pre-ACT intervention.|pre and immediately post intervention (50 mins post inhalation)||||unitless ratio (adenosine/Urea conc.)||Standard Deviation|Mean
2539234|NCT03078127|Secondary|Purine Analysis (Adenosine) in Exhaled Breath Condensate (EBC)|Difference of concentration of adenosine (a purine) in EBC between post-ACT and pre-ACT intervention.|pre and immediately post intervention (50 mins post inhalation)||||unitless ratio (adenosine/Urea conc.)||Standard Deviation|Mean
2539235|NCT03078127|Secondary|Purine Analysis (AMP) in Exhaled Breath Condensate|Exhaled breath condensate was collected using a commercial device for this purpose. Concentrations of the purine adenosine monophosphate (AMP) and urea in this liquid were determined using mass spectrometry. This outcome was the difference in concentrations of AMP normalized to urea in this exhaled breath condensate between post-ACT and pre-ACT intervention.|pre and immediately post intervention (50 mins post inhalation)||||unitless ratio (AMP/Urea conc.)||Standard Deviation|Mean
2539236|NCT03078127|Secondary|Change in Fraction of Exhaled Nitric Oxide (FENO)|FENO measurements were obtained pre- and post- intervention. The difference of post- vs pre- ACT FENO was reported.|pre and immediately post intervention (50 mins post inhalation)|Only subjects who had measurable FENO above detection limits of the device (i.e. <5 ppm) for both before and after ACT were included in analysis. Data from subjects during interventions who did not have a detectable FENO for both pre- and post- ACT were excluded for analysis.|||ppm of NO||Standard Deviation|Mean
2539237|NCT03078127|Secondary|Change in Rate of MCC|Change in slope of particle clearance curve between pre intervention and ACT period.|pre-ACT (0-16 mins) and during ACT (16-50 mins)|Only 4 subjects were included due to poor quality data obtained for slope measurement due to subject movement during the study (other MCC data used area under the curve data from key frames in which there was no subject movement, which proved to be more reliable). This data was not analyzed statistically.|||%clearance / minute||Full Range|Mean
2539238|NCT03078127|Secondary|Mucociliary Clearance-90|As described in the protocol, gamma scintigraphy was used to measure clearance of particles from the whole right lung region of interest over 274 minutes. This outcome for this study was the area under the particle clearance curve from time 0 to 90 minutes post-inhalation (normalized to time by dividing by 90) and expressed as a percent, representing average rate of mucociliary clearance (MCC) over 90 minutes.|90 minutes|All subjects were included for analysis|||percent clearance||Standard Deviation|Mean
2539239|NCT03078127|Primary|Mucociliary Clearance-274|As described in the protocol, gamma scintigraphy was used to measure clearance of particles from the whole right lung region of interest over 274 minutes. The primary outcome for this study was the area under the particle clearance curve from time 0 to 274 minutes post-inhalation (normalized to time by dividing by 274) and expressed as a percent, representing total average rate of mucociliary clearance (MCC).|274 minutes||||percent clearance||Standard Error|Mean
2539240|NCT03077893|Secondary|Nerve Conduction Velocity (NCV) - Amplitude|NC-stat® DPNCheck® will be used to record NCV at Baseline and Day 121. Outcome Measure Data table displays change in NCV from Baseline to Day 121.|The sural nerve conduction amplitude will be recorded at the Enrollment Visit and end of study visit (Day 121).||||meters/second||Standard Deviation|Mean
2539241|NCT03077893|Secondary|Neuro-QoL|"A validated set of health-related quality of life measures that are domain specific.Subjects will completed 6 domains: (1) Pain, (2) Lost/Reduced Feeling, (3) Diffuse Sensory Motor Symptoms, (4) Restrictions in Activities of Daily Living, (5) Disruptions in Social Relationships, and (6) Emotional Distress.The short forms were completed by the subject at the Enrollment Visit and end of study visit (Day 121). Each question in the domain was rated on a symptom scale from 1 (never) to 5 (all the time) and a bothersome scale from 1 (none) to 3 (very much).~The total score for the domain was calculated by multiplying the symptom score by the bothersome score. The scale range is from 1 to 15 where the minimum (best/least symptomatic) score is 1 and the maximum (worst/most symptomatic) score is 15."|Change in each domain from Baseline to Day 121 is displayed below.||||units on a scale||Standard Deviation|Mean
2539242|NCT03077893|Secondary|Hospital Anxiety and Depression Scale (HADS)|A patient reported 14 question assessment that detects the status of depression and anxiety. Subjects completed the assessment at the Enrollment Visit, Days 30, 61, 91, and end of study visit (Day 121). The total score for anxiety and the total score for depression was calculated at Day 121. Low scores represent normal (0-7) while high scores represent abnormal (11-21).|Change in Depression and Anxiety from Baseline to Day 121.||||units on a scale||Standard Deviation|Mean
2539243|NCT03077893|Secondary|Patient Global Impression of Change (PGIC)|A 7-choice validated categorical scale of overall change in status since initiation of treatment with the study device.PGIC was collected every 7 days in the paper diary, immediately following the morning treatment. Subjects were asked: Since the start of the study, my overall status is? Choices on the scale included: Very much worse, much worse, minimally worse, no change, minimally improved, much improved and very much improved.|PGIC results at Day 121 displayed below.||||Participants|||Count of Participants
2539376|NCT03075410|Primary|Number of Participants With Clinical Chemistry Parameters of PCI for Part B|Blood samples were collected for the assessment of clinical chemistry parameters namely BUN, creatinine, glucose, cholesterol, potassium, sodium, calcium, AST, ALT, alkaline phosphatase, triglycerides, total and direct bilirubin, total protein, albumin and troponin. Only categories with PCI values have been presented.|Up to 8 weeks|Safety Population for Part B|||Participants|||Count of Participants
2539244|NCT03077893|Secondary|Brief Fatigue Inventory (BFI)|A 4-question assessment that assesses the level of fatigue and the impact of the fatigue on daily function over the last 24 hours. BFI is patient reported and collected at the Enrollment Visit, Days 30, 61, 91, and end of study visit (Day 121). A global fatigue score was calculated by averaging all of the values on the questionnaire and results for the change from Baseline to Day 121 are displayed below. The scale ranged from 0 (no fatigue/does not interfere) to 10 (as bad as you can imagine/completely interferes).|Change from Baseline to Day 121 in BFI.||||units on a scale||Standard Deviation|Mean
2539245|NCT03077893|Secondary|Brief Pain Inventory (BPI); Question on Pain Right Now.|The BPI long form will be administered at the Enrollment Visit, Day 30, 61, 91, and end of study visit (Day 121). Results for question #15 on Pain Right Now displayed below. Subject were asked to rate pain right now on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Change in BPI, pain right now question, from Baseline to Day 121.||||units on a scale||Standard Deviation|Mean
2539246|NCT03077893|Secondary|Pain Intensity (PI)|Mean change from Baseline to Day 121, using a validated 11-point Numeric Pain Rating Scale (NPRS) with scores 0-10, where 0 = no pain and 10 = worst possible pain.|Collected as patient-reported outcomes on a paper diary and at the Enrollment visit to obtain a baseline value and on Days 61, 75, and 91||||units on a scale||Standard Deviation|Mean
2539247|NCT03077893|Secondary|Skin Perfusion Pressures (SPP)|The Vasamed Sensilase PAD-IQ will be used to record SPP. This machine measures pressure (in mm Hg) of microcirculation using a laser Doppler sensor. Outcome Measure Data Table below displays change from Baseline to Day 121.|SPP will be conducted at the Enrollment Visit, Day 61, and end of study visit (Day 121).||||mmHg||Standard Deviation|Mean
2539248|NCT03077893|Secondary|Nerve Conduction Velocity (NCV) - Velocity|NC-stat® DPNCheck® will be used to record NCV at Baseline and Day 121. Outcome Measure Data table displays change in NCV from Baseline to Day 121.|The sural nerve conduction velocity will be recorded at the Enrollment Visit and end of study visit (Day 121).||||micro volts||Standard Deviation|Mean
2539249|NCT03077893|Primary|Quantitative Sensory Testing (QST)|QST is a noninvasive test used in peripheral nervous system disorders for thermal sensory testing.|Baseline to End of Treatment (Day 121)|Number analyzed in outcome measure table is less than overall number analyzed due to drop-outs and technical issues with the QST machine.|||Participants|||Count of Participants
2539250|NCT03077893|Primary|Vibration Perception Threshold (VPT)|A non-invasive test used in quantifying sensation/sensitivity to vibration in evaluating sensory dysfunction associated with diabetic neuropathy|Baseline to End of Treatment (Day 121)||||amplitude in microns||Standard Deviation|Mean
2539251|NCT03077724|Secondary|Point Prevalence Abstinence|Point prevalence abstinence at 4 weeks biochemically confirmed by end-expired carbon monoxide|4 weeks|Subjects with complete baseline and 4-week measures|||Participants|||Count of Participants
2539252|NCT03077724|Secondary|Change in Fagerström Scores From Baseline to 4-weeks|Change in the Fagerström Test for Nicotine Dependency Score from baseline to 4-weeks. This scale is a validated instrument that measures nicotine dependency. The Fagerström Test for Nicotine Dependency is a 6-time survey. Each item is scores with a minimal score of 0 and a maximal score of 10. Higher scores indicate a higher level of nicotine dependency.|4 weeks|Change from baseline at 4-weeks in Fagerstrom scores|||score on a scale||Inter-Quartile Range|Median
2539253|NCT03077724|Primary|Change in Cigarettes Per Day From Baseline to 4-weeks|Change in total number of cigarettes per day from baseline to 4-weeks|4 weeks|Participants with both baseline and 4-week complete data on cigarettes smoked per day|||Cigarettes smoked per day||Inter-Quartile Range|Median
2539254|NCT03077711|Secondary|Bacterial Infection Prevalence and Types|Urine cultures and sensitivities for positive urine cultures|up to 12 months||||infections|||Number
2539255|NCT03077711|Secondary|Morisky Medication Adherence Survey|Morisky Medication Adherence Scale-8 (MMAS-8). Patient tolerability of medications using a tolerability survey. Minimum and maximum scores are 0 and 8 respectively. 0 means no adherence and 8 is maximal adherence. Low adherence corresponds to a score less than 6, medium adherence is between 6 and <8, and 8 is high adherence.|up to 12 months|We were not able to obtain the Morisky medication survey on all participants.|||units on a scale||Standard Deviation|Mean
2539256|NCT03077711|Secondary|Adverse Effects|The percentage of patients complaining of adverse effects of each medication, including dyspepsia, dysuria, rash, pruritus, nausea, epigastric pain, vomiting, glossitis, taste changes, fever, and photosensitivity.|up to 12 months||||Participants|||Count of Participants
2539257|NCT03077711|Primary|Number of Infections|The number of infections at a 12 month follow up time period as defined by symptoms and positive urine culture.|up to 12 months||||urinary tract infections||Standard Deviation|Mean
2539258|NCT03077711|Primary|Recurrent UTI|The number of patient who had a recurrence of UTI within 12 months|up to 12 months||||Participants|||Count of Participants
2539259|NCT03077711|Primary|Time to Subsequent Infection as Defined From Time of Treatment Initiation to Recurrence of UTI|Patients will be advised to follow up with any symptoms of a recurrence or at 6 and 12 month intervals if symptom-free.|up to 12 months||||days||Standard Deviation|Mean
2539260|NCT03077659|Post-Hoc|Tumor Invasion Into Surrounding Tissues|Assessed histologically after TRUS biopsy at Screening and on Day 29 prior to prostatectomy.|Screening and Day 29|Full Analysis Set|||Participants|||Count of Participants
2539261|NCT03077659|Post-Hoc|Change in PI-RADS Score|The Prostate Imaging Reporting and Data System (PI-RADS) assessment uses a five-point scale based on the probability that a combination of mpMRI findings on T2 weighting (T2W), Diffusion Weighted Imaging (DWI), and Dynamic Contrast Enhancement (DCE) correlates with the presence of a clinically significant cancer in the prostate gland. A PI-RADS score of 1 is considered to be most probably benign and a score of 5 is considered to be highly suspicious of a prostate malignancy. PI-RADS 1: very low (clinically significant cancer is highly unlikely to be present); PI-RADS 2: low (clinically significant cancer is unlikely to be present); PI-RADS 3: intermediate (presence of clinically significant cancer is equivocal); PI-RADS 4: high (clinically significant cancer is likely to be present); PI-RADS 5: very high (clinically significant cancer is highly likely to be present).|Screening and Day 29|Full Analysis Set|||Participants|||Count of Participants
2539262|NCT03077659|Post-Hoc|Change in PSA Density|PSA density was measured with mpMRI|Screening and Day 29|Full Analysis Set|||ng/mL/cc||Standard Deviation|Mean
2547895|NCT02896595|Secondary|Total Intra-procedure Opioids|Measured in mcg of Fentanyl|Up to 270 minutes||||mcg||Standard Error|Mean
2539265|NCT03077659|Secondary|Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score)|Prostate tissue samples were obtained via biopsy at baseline and immediately prior to prostatectomy (Day 29). Histologic evaluation of these samples was used to determine the Gleason score, and the results at baseline and Day 29 were used to evaluate the tumor response to treatment with NanoPac®. The Gleason score is calculated by adding together the two grades of cancer cells that make up the largest areas of the biopsied tissue sample. The Gleason score usually ranges from 6 to 10. The lower the Gleason score, the more the cancer cells look like normal cells and are likely to grow and spread slowly; a higher Gleason score is likely to indicate a worse outcome. The Gleason score is used to help plan treatment and determine prognosis.|Screening and Day 29|Full Analysis set|||score on a scale||Standard Deviation|Mean
2539266|NCT03077659|Secondary|Tumor Response Based on Change in Image Volume on mpMRI|Tumor response to treatment with NanoPac was determined by evaluating the change in image volume with multiparametric MRI (mpMRI) within three months prior to consent and again within 48 hours of the prostatectomy procedure (Day 29). In those cases where two dimensions/axes were available, width was imputed to height for the purposes of calculation, i.e. the lesion was assumed to be an oblate spheroid. In those cases where only one dimension/axis was available, that dimension/axis was imputed for all three dimensions i.e. the lesion was assumed to be a sphere. For this reason, analyses were performed for all subjects with two dimensions available, as well as those for which at least one dimension was available. The data presented for this outcome measure is the one dimension lesion volume calculation: Lesion Volume (cc) = (3.14/6)*(length)³, where length is the longer or only measured dimension.|Up to three months prior to consent and Day 29|Full Analysis Set|||cc||Standard Deviation|Mean
2539267|NCT03077659|Primary|Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)|Treatment Emergent Adverse Events included laboratory assessments, physical examination findings, and vital signs.|Day 1 to Day 29|Full Analysis Set|||Participants|||Count of Participants
2539268|NCT03077607|Secondary|Number of Participants With Clinically Significant Physical Examination Findings|Physical examination included examination of abdomen, cardiovascular, eyes, ears, nose, throat, general appearance, head, neck, thyroid, lymph nodes, musculoskeletal, neurological, skin / subcutaneous tissue, thorax / lungs, abdomen including spleen size, breasts (female only) and respiratory. Clinical significance of physical examination was judged by investigator.|Baseline up to end of study (up to 61 days)|Safety analysis set included all participants who received at least 1 dose of talazoparib.|||Participants|||Count of Participants
2539269|NCT03077607|Secondary|Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)|ECG abnormalities: a) QT Interval: new absolute values greater than (>) 450, >480, >500 milliseconds (msec), increase from baseline >30 and >60 msec, b) QT interval using Fridericia's correction (QTcF) Interval: new absolute values >450, >480, >500 msec, increase from baseline >30 and > 60 msec, c) Heart rate: increase from baseline >25 percentage (%) and to a value >100 bpm, decrease from baseline >25% and to a value <50 bpm, d) PR Interval: increase from baseline > 25% and to a value >200 msec, e) QRS duration: increase from baseline > 25% and to a value >100 msec. Clinical significance of ECG abnormalities was judged by investigator.|Baseline up to end of study (up to 61 days)|Safety analysis set included all participants who received at least 1 dose of talazoparib.|||Participants|||Count of Participants
2539270|NCT03077607|Secondary|Number of Participants With Clinically Significant Abnormalities in Vital Signs|Vital sign abnormalities: a) systolic blood pressure (SBP): 1) minimum less than (<) 90 millimeter of mercury (mmHg), 2) change from baseline maximum decrease greater than equal to (>=) 30 mmHg, 3) change from baseline maximum increase >=30 mmHg; b) diastolic blood pressure (DBP): 1) minimum <50 mmHg, 2) change from baseline maximum decrease >=20 mmHg, 3) change from baseline maximum increase >=20 mmHg; c) supine pulse rate: 1) minimum <40 beats per minute (bpm), 2) maximum >120 bpm; d) standing pulse rate: 1) minimum <40 bpm and 2) maximum >140 bpm. Clinical significance of vital signs abnormalities was judged by investigator.|Baseline up to end of study (up to 61 days)|Safety analysis set included all participants who received at least 1 dose of talazoparib.|||Participants|||Count of Participants
2539271|NCT03077607|Secondary|Number of Participants With Clinical Significance Abnormalities in Laboratory Parameters|Chemistry:(sodium135-146,potassium3.5-5.5,chloride95-109,glucose3.3-5.5,urea2.8-7.2,calcium2.2-2.65,phosphate0.8-1.45,triglyceride0.4-1.7,cholesterol2.6-5.2)millimoles/L, (bilirubin[direct0-3,total2-21],creatinine53- 110)micromole/L, (albumin35-52,protein65-83)g/L,(alkaline phosphatase30-120, aspartate amino[A]transferase[T]4-46, alanine AT4-49, lactic acid dehydrogenase200-460, gammaglutamylT7-50,creatinine kinase24-170)U/L. Hematology: hemoglobin(Hb)120-177, hematocrit0.35-0.49L/L, RBC4-5.9T/L, (platelet150- 400,WBC4-10,basophil<0.10,eosinophil<0.40, neutrophil1.50-7.00,monocyte<1.20,lymphocyte1.0 -3.70)G/L. Urine:(glucose,protein,ketone,Hb:negative/positive), specific gravity1.010-1.030g/cm^3, pH4.8-7.8, pale yellow-deep amber, microscopy[WBC0-5,leukocyte0-5,Hb0-3,cast0-1,bacteria0-500,epithelial0-6])Pcs/area. Coagulation:(activated partial thromboplastine time25-43,prothrombin time13.7-15.6) seconds,international normalized ratio0.89-1.1. Investigator judged clinical significance.|Baseline up to end of study (up to 61 days)|Safety analysis set included all participants who received at least 1 dose of talazoparib.|||Participants|||Count of Participants
2539272|NCT03077607|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pre-treatment state. AEs included both serious and non-serious adverse events.|Baseline up to end of study (up to 61 days)|Safety analysis set included all participants who received at least 1 dose of talazoparib.|||Participants|||Count of Participants
2539302|NCT03076970|Primary|Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) QT Duration|A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.|Pre-dose, 24 hours post-dose|All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period.|||msec||Standard Deviation|Mean
2539273|NCT03077607|Secondary|Apparent Clearance (CL/F) of Talazoparib: Alone and in Combination With Rifampin|"Clearance of talazoparib was measure of the rate at which it was metabolized or eliminated by normal biological processes. T3= Time frame for Talazoparib 1.0 mg Alone and T4= time frame for Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD."|T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25|"PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, N signifies those participants who were evaluable for this outcome measure."|||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
2539274|NCT03077607|Secondary|Apparent Volume of Distribution During Terminal Phase (Vz/F) of Talazoparib: Alone and in Combination With Rifampin|"Apparent volume of distribution was defined as the theoretical volume in which the total amount of talazoparib would need to be uniformly distributed to produce its desired plasma concentration. T3= Time frame for Talazoparib 1.0 mg Alone and T4= time frame for Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD."|T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25|"PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, N signifies those participants who were evaluable for this outcome measure."|||Liter||Geometric Coefficient of Variation|Geometric Mean
2539275|NCT03077607|Secondary|Terminal Elimination Half-Life (t1/2) of Talazoparib: Alone and in Combination With Rifampin|"Terminal elimination half-life was defined as time measured for the plasma concentration of talazoparib to decrease by one half. T3= Time frame for Talazoparib 1.0 mg Alone and T4= time frame for Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD."|T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25|"PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, N signifies those participants who were evaluable for this outcome measure."|||Hours||Standard Deviation|Mean
2539276|NCT03077607|Secondary|Time to Attain Maximum Observed Plasma Concentration (Tmax) of Talazoparib: Alone and in Combination With Rifampin|"T3= Time frame for Talazoparib 1.0 mg Alone and T4= time frame for Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD."|T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25|PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.|||Hours||Full Range|Median
2539277|NCT03077607|Secondary|Apparent Volume of Distribution During Terminal Phase (Vz/F) of Talazoparib: Alone and in Combination With Itraconazole|"Apparent volume of distribution was defined as the theoretical volume in which the total amount of talazoparib would need to be uniformly distributed to produce its desired plasma concentration. T1= Time frame for Talazoparib 0.5 mg Alone and T2= time frame for Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID."|T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23|"PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, N signifies those participants who were evaluable for this outcome measure."|||Liter||Geometric Coefficient of Variation|Geometric Mean
2539278|NCT03077607|Secondary|Apparent Clearance (CL/F) of Talazoparib: Alone and in Combination With Itraconazole|"Clearance of talazoparib was measure of the rate at which it was metabolized or eliminated by normal biological processes. T1= Time frame for Talazoparib 0.5 mg Alone and T2= time frame for Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID."|T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23|"PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, N signifies those participants who were evaluable for this outcome measure."|||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
2539279|NCT03077607|Secondary|Terminal Elimination Half-Life (t1/2) of Talazoparib: Alone and in Combination With Itraconazole|"Terminal elimination half-life was defined as time measured for the plasma concentration of talazoparib to decrease by one half. T1= Time frame for Talazoparib 0.5 mg Alone and T2= time frame for Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID."|T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23|"PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, N signifies those participants who were evaluable for this outcome measure."|||Hours||Standard Deviation|Mean
2539280|NCT03077607|Secondary|Time to Attain Maximum Observed Plasma Concentration (Tmax) of Talazoparib: Alone and in Combination With Itraconazole|"T1= Time frame for Talazoparib 0.5 mg Alone and T2= time frame for Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID."|T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23|PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.|||Hours||Full Range|Median
2539281|NCT03077607|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of Talazoparib: Alone and in Combination With Rifampin|"T3= Time frame for Talazoparib 1.0 mg Alone and T4= time frame for Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD."|T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25|"PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, N signifies those participants who were evaluable for this outcome measure."|||hr*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2539282|NCT03077607|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Talazoparib: Alone and in Combination With Rifampin|"T3= Time frame for Talazoparib 1.0 mg Alone and T4= time frame for Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD."|T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25|PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.|||hr*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2539283|NCT03077607|Primary|Maximum Observed Plasma Concentration (Cmax) of Talazoparib: Alone and in Combination With Rifampin|"T3= Time frame for Talazoparib 1.0 mg Alone and T4= time frame for Talazoparib 1.0 mg in Combination With Rifampin 600 mg QD."|T3=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T4=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 25|PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2539284|NCT03077607|Primary|Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinity (AUC0-inf) of Talazoparib: Alone and in Combination With Itraconazole|"T1= Time frame for Talazoparib 0.5 mg Alone and T2= time frame for Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID."|T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23|"PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters. Here, “Overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure."|||hr*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2539285|NCT03077607|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Talazoparib: Alone and in Combination With Itraconazole|"T1= Time frame for Talazoparib 0.5 mg Alone and T2= time frame for Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID."|T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23|PK analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.|||Hour*picogram per milliliter (hr*pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2539286|NCT03077607|Primary|Maximum Observed Plasma Concentration (Cmax) of Talazoparib: Alone and in Combination With Itraconazole|"T1= Time frame for Talazoparib 0.5 mg Alone and T2= time frame for Talazoparib 0.5 mg in Combination With Itraconazole 100 mg BID."|T1=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 1; T2=Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264 and 336 hours post Talazoparib dose on Day 23|Pharmacokinetic (PK) analysis population included all participants who enrolled, treated and had at least 1 of the talazoparib PK parameters.|||Picogram per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2539287|NCT03076996|Secondary|Adherence to Follow-up Visit Within 1 Month of Scheduled Date|Retention in HIV services will be measured using data abstracted from the medical record system on date of visits between enrollment and the endline of this study. To be considered retained in HIV services, an individual must, at 3 months after enrollment, have attended his/her most recently scheduled clinical follow-up visit within 1 month of the date when it was scheduled to take place.|3 months|Participants enrolled in study at baseline|||Participants|||Count of Participants
2539288|NCT03076996|Secondary|Adherence to ART as Measured by the AACTG Adherence Assessment|Proportion of participants who report not having missed any ART doses in past 3 days.|3 months|Participants who completed end line questionnaire|||Participants|||Count of Participants
2539289|NCT03076996|Secondary|Acceptability Score|Acceptability score: A set of ten items asking if participants agreed=1 or disagreed=0 with statements on acceptability. Score represents a sum of the 10 items with a range of 0 to 10, and a greater number indicating agreement with more acceptability items.|3 months|Endline participants who participated in the intervention|||Scores on Scale||Full Range|Mean
2539290|NCT03076996|Primary|Percentage of Active Members Who Have at Least One Post in Group Chat Session.|Participants level of engagement in support group activities informs on the feasibility of intervention, measured by percentage of active members who have at least one post in group chat session.|3 months|Participants who initiated the intervention|||Participants|||Count of Participants
2539291|NCT03076983|Secondary|"Assessing the Use Specific Clinical Helpfulness of PulmoVista 500 by Particular Questionnaire. The Questions Which Were Asked Within the Questionaire Are Listed in the Outcome Measure Description"|"How easy is it to...~Q1: ... identify within the Tidal Image, whether the right and the left lung are evenly ventilated? Q2: ... quantify the regional ventilation distribution as expressed by the regional Parameters TV ROI 1 - TV ROI 4? Q3: ... set the cursors to respective positions which allow you to compare ventilation distribution before and after the intervention? Q4: ... detect increases and/or decreases of regional ventilation? Q5: ... relate the regional ventilation distribution to and the corresponding parameters from the ventilator, which are displayed in the trend table to each other? Q7: ... set the cursors to respective positions which allows you assessing lung volume changes induced by the intervention? Q8: ... detect increases and/or decreases of regional lung volume?~How useful is the clinical Information on...~Q6: ... ventilation redistribution caused by this intervention? Q9: ... regional lung volume changes caused by this intervention?"|Day 1||||Participants|||Count of Participants
2539292|NCT03076983|Secondary|Safety - Documentation of Any Safety Events|Documentation of any safety events related to the use of PulmoVista 500|Day 1||||Participants|||Count of Participants
2539303|NCT03076970|Primary|Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: QTcF - Fridericia's Correction Formula|A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.|Pre-dose, 24 hours post-dose|All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period.|||msec||Standard Deviation|Mean
2539293|NCT03076983|Secondary|Assess Changes of the End-expiratory Lung Volumes|"Assess that changes of the end-expiratory lung volumes (induced by e.g. PEEP changes, recruitment and suctioning maneuvers) can be monitored by dEELI trend view~To assess if the changes of the end-expiratory lung volumes (induced by e.g. PEEP changes, recruitment and suctioning maneuvers) can be monitored by dEELI trend view, the physician was asked to answer following two question of a questionnaire:~Question 1: Open the view dEELI trend after the PEEP setting has been changed. Set C1 at the lower and C2 at the higher PEEP level. Does the image dEELI: C2 minus C1 show the expected increase of end-exp. lung volume in turquoise (light-blue)?~Question 2: Open the view dEELI trend after lung suction has been conducted. Set C1 at a phase before and C2 during or immediately after the lung suction. Does the image dEELI: C2 minus C1 show the expected decrease of lung volume in orange color?~Possible answers for the both above mentioned questions were No,Yes or N/A2"|Day 1|"These two questions are only applicable to the patient group of ICU Patients as no assessment of the changes of the end-expiratory lung volume was planned a priori within the OLV patient group."|||Participants|||Count of Participants
2539294|NCT03076983|Secondary|Assess Changes of Tidal Volumes|"Assess that changes of tidal volumes induced by ventilator settings can be monitored by the Trends view~To assess if the changes of tidal volumes induced by ventilator settings can be monitored by the Trends view, the physician was asked to answer following question of a questionnaire:~Open the view End-insp. trend after the PEEP setting has been changed significantly (2 mbar or more). Set C1 at the lower and C2 at the higher PEEP level.~Does the image Change: C2 minus C1 and/or the corresponding regional Tidal Variations show the expected redistribution of ventilation from ventral to dorsal?~Possible answers were: No, Yes and N/A"|Day 1|"This question is only applicable to the patient group of ICU Patients as no assessment of the changes of tidal volumes induced by ventilator settings was planned a priori for the OLV patient group."|||Participants|||Count of Participants
2539295|NCT03076983|Secondary|Detection of Changes in Regional Ventilation|To assess the capability of PulmoVista 500 to detect changes in regional ventilation by evaluating the cross correlation between impedance waveforms derived from PulmoVista 500 and volume curves derived from ventilator during one-lung-ventilation.|Day 1|"For this secondary endpoint the cross-correlation between between impedance waveforms derived from PulmoVista 500 and volume curves derived from Ventilator was calculated only for patients which received one-lung-ventilation (OLV).~Therefore no patients from the ICU patients Group were included into the analysis."|||correlation coefficient||Standard Deviation|Mean
2539296|NCT03076983|Primary|Monitoring Capabilities of PulmoVista 500|"The cross-correlation between the volume curve of the ventilator and the global impedance curve of PulmoVista 500 was expressed by the cross-correlation coefficient R.~The cross-correlation coefficient is a measure to quantify the relationship between the volume curve and the EIT curve.~The correlation coefficient R can assume values between [-1, 1] to describe the relationship between the two curves, as is usual for a correlation.~To calculate the correlation coefficient, a phase shift between the two curves was taken into account, so the cross-correlation between them was calculated.~The phase shift or delay occurs when the signal from the fan is transmitted to the PulmoVista500.~The cross-correlation coefficient is determined by calculating the correlation coefficient for the curves within a narrow range of Lags(-15 to 15 ) for each pair of curves and using the maximum value as the value of correlation coefficient (therefore it is called cross-correlation coefficient)"|Day 1|A Intention-to-Treat (ITT) collective was used as analysis population. The intention-to-treat collective comprises all patients for which both, the impedance waveforms and parallel to them volume waveforms have been generated during ventilation,so that the primary endpoint can be evaluated.|||correlation coefficient||Standard Deviation|Mean
2539297|NCT03076970|Secondary|Pharmacokinetics - Tmax|Time to maximum plasma concentration of lasmiditan alone compared to lasmiditan in combination with sumatriptan.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours following the dose at time 0 in each dosing period|All participants who completed at least one treatment period without any protocol violations, who have evaluable plasma concentration data for lasmiditan and/or sumatriptan (Imitrex), and for whom at least a subset of the designated PK parameters can be determined.|||hour||Full Range|Mean
2539298|NCT03076970|Secondary|Pharmacokinetics - AUC0-t|Area under the plasma concentration versus time curve from time 0 to the time t of the last quantifiable concentration, calculated by means of the mixed log-linear trapezoidal rule of lasmiditan alone compare to lasmiditan in combination with sumatriptan.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours following the dose at time 0 in each dosing period|All participants who completed at least one treatment period without any protocol violations, who have evaluable plasma concentration data for lasmiditan and/or sumatriptan (Imitrex), and for whom at least a subset of the designated PK parameters can be determined.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2539299|NCT03076970|Secondary|Pharmacokinetics - Cmax|Maximum plasma concentration of lasmiditan alone compared to lasmiditan in combination with sumatriptan.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours following the dose at time 0 in each dosing period|All participants who completed at least one treatment period without any protocol violations, who have evaluable plasma concentration data for lasmiditan and/or sumatriptan (Imitrex), and for whom at least a subset of the designated PK parameters can be determined.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2539300|NCT03076970|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Safety assessed from time of consent through end of study. A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the adverse events module of this record.|Up to 6 weeks|All participants who received at least one dose of study drug (lasmiditan or sumatriptan).|||Participants|||Count of Participants
2539301|NCT03076970|Primary|Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) RR Duration|A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.|Pre-dose, 24 hours post-dose|All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period.|||msec||Standard Deviation|Mean
2547896|NCT02896595|Secondary|Time to Discharge From PACU|time from arrival to PACU until discharge from anesthesia care|Up to 7 days|Data not collected for this variable||||||
2539304|NCT03076970|Primary|Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: QTcB - Bazett's Correction Formula|A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.|Pre-dose, 24 hours post-dose|All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period.|||msec||Standard Deviation|Mean
2539305|NCT03076970|Primary|Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) QRS Duration|A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.|Pre-dose, 24 hours post-dose|All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period.|||msec||Standard Deviation|Mean
2539306|NCT03076970|Primary|Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Summary (Mean) PR Duration|A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.|Pre-dose, 24 hours post-dose|All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period.|||milliseconds (msec)||Standard Deviation|Mean
2539307|NCT03076970|Primary|Pharmacodynamics- Change From Pre-dose to 24 Hours in ECGs: Heart Rate|A standard, digital 12-lead ECG with a 10-second rhythm strip was used to assess cardiac function after participants have been at least 5 minutes supine. Serial ECGs collected when lasmiditan administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.|Pre-dose, 24 hours post-dose|All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period.|||beats/min||Standard Deviation|Mean
2539308|NCT03076970|Primary|Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Respiratory Rate|Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.|Pre-dose, 24 hours post-dose|All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period.|||breaths/min||Standard Deviation|Mean
2539309|NCT03076970|Primary|Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Temperature|Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.|Pre-dose, 24 hours post-dose|All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period.|||Celsius (C)||Standard Deviation|Mean
2539310|NCT03076970|Primary|Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Pulse Rate|Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.|Pre-dose, 24 hours post-dose|All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period.|||beats/min||Standard Deviation|Mean
2539311|NCT03076970|Primary|Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Diastolic Blood Pressure|Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.|Pre-dose, 24 hours post-dose|All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period.|||mmHg||Standard Deviation|Mean
2539312|NCT03076970|Primary|Pharmacodynamics- Change From Pre-dose to 24 Hours in Vital Signs: Systolic Blood Pressure|Vital signs were measured in semi-supine position after 5 minutes rest. Serial vital signs assessed when lasmiditan is administered alone and when sumatriptan is administered alone compared to when lasmiditan and sumatriptan are administered together.|Pre-dose, 24 hours post-dose|All participants who received at least one dose of study drug (lasmiditan or sumatriptan) and have completed at least one treatment period.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2539313|NCT03076190|Other Pre-specified|Characterize Responders to My Surgical Success (Demographics and Psychological Correlates)|The investigators will report the baseline psychosocial scores (PROMIS measures) for patients who report high satisfaction with the My Surgical Success treatment. Pain Intensity Scale ranges from 0 (no Pain) to 10 (the worst pain imaginable), with higher scores indicating worse pain. Total scores range from 0-10. Pain Catastrophizing Scale is a 13-item measure assessing levels of pain catastrophizing. Scores range from 0-52, with a higher score indicating higher levels of pain catastrophizing. All PROMIS assessments were converted from raw scores to t-scores (M= 50, SD=10). There are no minimum and maximum values as these are standardized scores. PROMIS Pain Intensity, Pain Interference, Physical Function, Depression, Anxiety, were administered at baseline. Higher scores on PROMIS depression, anxiety, pain interference, and pain intensity signify greater severity of these symptoms. However, higher scores on Physical Function reflects a greater level of physical functioning.|Baseline||||score on a scale||Standard Deviation|Mean
2539314|NCT03076190|Other Pre-specified|Group Difference in Post-surgical PROMIS Physical Function and PROMIS Pain Interference|PROMIS scores for physical function and pain interference will be reported post-surgically. All PROMIS assessments were converted from raw scores to t-scores (Mean= 50, SD=10). Higher scores on PROMIS pain interference signify greater severity of pain interfering with patient's functioning. However, higher scores on Physical function reflects a greater level of physical functioning. The investigators will conduct within subject analyses and will report pre-post treatment changes.|From baseline to post-surgery (up to 4 months duration of the study)||||score on a scale||Standard Deviation|Mean
2539495|NCT03070730|Secondary|Change in Physical Functioning- HADS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Hospital Anxiety and Depression Scales.|1 week after second intervention|||||||
2539315|NCT03076190|Other Pre-specified|Group Difference in Time to Opioid Cessation|"Postsurgical opioid stop date was self-reported by patients. The opioid stop date was collected through the two-, four-, eight-, and 12-week follow-up surveys with the question On what date did you stop taking your opioid medication? The number of postsurgical days using opioids was calculated by subtracting the opioid stop date from the surgery date obtained in the medical chart. Statistical analyses present the data in mean number of days to opioid cessation in each group."|Data on opioid use was collected for the 4 month duration of the study||||Days to opioid cessation||Standard Error|Mean
2539316|NCT03076190|Secondary|Group Difference in Within-subject Pain Catastrophizing|Pain Catastrophizing Scale is a validated 13-item measure assessing levels of pain catastrophizing. Scores range from 0-52, with a higher score indicating higher levels of pain catastrophizing. Data below presents total scores on the scale.|Before surgery to post-surgically|Before Surgery|||score on a scale||Standard Error|Mean
2539317|NCT03076190|Primary|Participant Ratings (0-6) for Satisfaction, Usefulness of the Information Presented, Relevance, Ease of Understanding, and Likelihood to Use Skills Learning|Participants complete a single time point rating for 5 items listed above. Ratings occur on a 0-6 point scale (e.g., 0=completely useless and 6=Very useful). Means and Standard Deviations are reported per the table below.|Immediately post-treatment||||units on a scale||Standard Deviation|Mean
2539318|NCT03075904|Secondary|Maximum Percent Reduction Of Mean Anti-Desmoglein (Dsg) 1 And 3 Antibodies From Baseline|Pharmacodynamic samples were collected for analysis throughout the study. The maximum percent reduction of mean anti-Dsg 1 and 3 antibodies from Baseline observed during the study is presented.|Baseline through Day 112|All participants who received at least 1 dose of study drug and had postdose pharmacodynamic data available.|||percentage of reduction|||Number
2539319|NCT03075904|Secondary|Maximum Percent Reduction Of Mean Circulating Immune Complexes (CIC) Levels From Baseline|Pharmacodynamic samples were collected for analysis throughout the study. The maximum percent reduction of mean CIC levels from Baseline observed during the study is presented.|Baseline through Day 112|All participants who received at least 1 dose of study drug and had postdose pharmacodynamic data available.|||percentage of reduction|||Number
2539320|NCT03075904|Secondary|Maximum Percent Reduction In Mean Pemphigus Disease Area Index (PDAI) Total Activity Score From Baseline|Pemphigus severity and disease activity was measured using the PDAI in regions where a validated questionnaire was available. The PDAI was administered during Treatment Period and Follow-up Period. PDAI total activity was comprised of scores for the skin, mucous membrane, and scalp subscales. The investigator determined a PDAI score as 0 to 250 points for total activity score (0 to 120 for skin, 0 to 10 for scalp, and 0 to 120 for mucosa). A higher score indicated higher impact on skin disease. The maximum percent reduction in PDAI total activity score from Baseline observed during the study is presented.|Baseline through Day 112|All participants who received at least 1 dose of study drug and had postdose pharmacodynamic data available.|||percentage of reduction|||Number
2539321|NCT03075904|Secondary|Maximum Percent Reduction Of Mean Total Immunoglobulin G (IgG) Levels From Baseline|Pharmacodynamic samples were collected for analysis throughout the study. The maximum percent reduction of mean serum total IgG levels from Baseline observed during the study is presented.|Baseline through Day 112|All participants who received at least 1 dose of study drug and had postdose pharmacodynamic data available.|||percentage of reduction|||Number
2539322|NCT03075904|Primary|Count Of Participants Reporting Treatment-emergent Adverse Events (TEAEs)|"A TEAE was defined as any adverse event (AE) that starts on or after the first dose of study drug or occurs prior to the first dose and worsens in severity on or after the first dose of study drug, during the Treatment Period and Follow-up Period. A TEAE was considered serious (Grade 3) if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: death, life-threatening adverse drug event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, or an event that may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the previously listed outcomes. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module."|Day 1 (after first dose) through Day 112|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2539323|NCT03075891|Primary|Percent Change From Baseline in Inflammatory Lesion Count|Percent change from Baseline in Inflammatory Lesion count at week 12|Baseline, Week 12|ITT/LOCF (Intent to treat / last observation carried forward)|||percentage of change||Standard Deviation|Mean
2539324|NCT03075839|Secondary|Quitting Interest|"Self-reported subjective motivation/interest in quitting smoking after switching to non-menthol cigarettes. Measured by the item how important is quitting smoking to you? from 1 not at all to 10 extremely."|Week 4 (non-menthol)||||units on a scale||Standard Deviation|Mean
2539325|NCT03075839|Secondary|Nicotine Dependence|Self-reported subjective ratings of nicotine dependence after switching to non-menthol cigarettes (measured as change in Wisconsin Inventory of Smoking Dependence Motives (WISDM) total dependence scores). Total range 11-77 with higher scores indicating greater nicotine dependence.|Week 4 (non-menthol)||||score on a scale||Standard Deviation|Mean
2539326|NCT03075839|Primary|Total Number of Cigarettes Smoked|Change in self-reported total number of cigarettes smoked per day after switching to non-menthol cigarettes|Menthol smoking (Week 2), Non-menthol smoking (Week 4)||||change in average cigarettes per day||Standard Deviation|Mean
2539327|NCT03075553|Secondary|Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events|The number of participants who experienced at least one grade 3 or higher adverse events are summarized below.|Up to 390 days||||Participants|||Count of Participants
2539328|NCT03075553|Secondary|Overall Survival (OS)|The distribution of survival time will be estimated using the method of Kaplan-Meier.|The time from registration to death due to any cause, assessed up to 2 years||||months||95% Confidence Interval|Median
2539343|NCT03075449|Secondary|The Percentage of Men With a Diagnostic Testing Procedure Ordered or Performed Specifically for Their Urinary Symptoms.|"The percentage of men with a diagnostic testing procedure ordered or performed specifically for their urinary symptoms.~95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution."|12 months|FAS|||Percentage of participants||95% Confidence Interval|Number
2539329|NCT03075553|Secondary|Progression-Free Survival (PFS)|The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. In addition, the progression-free survival rate will be reported. progressive disease (PD): a Lugano score of 4 to 5 with increasing intensity compared to baseline or any interim scan and/or any new FDG-avid focus consistent with malignant lymphoma.The Lugano 5-PS is a scale used for initial staging and assessment of treatment response in Hodgkin lymphoma (HL) and certain types of non-Hodgkin lymphomas (NHL). The scale ranges from 1 to 5, where 1 is best and 5 is the worst. Each FDG-avid (or previously FDG-avid) lesion is rated independently: 1. no uptake or no residual uptake 2. slight uptake, but equal to or below blood pool 3. uptake above mediastinal, but below or equal to uptake in the liver 4. uptake slightly to moderately higher than liver 5. markedly increased uptake or any new lesion (on response evaluation)|The time from registration to relapse or death due to any cause, an average of 2 years||||months||95% Confidence Interval|Median
2539330|NCT03075553|Secondary|Duration of Response (DOR)|The distribution of duration of response (CR or PR) will be estimated using the method of Kaplan-Meier. Complete response (CR): target nodes/nodal masses must regress to <=1.5 cm in longest transverse diameter (LDi). Partial response (PR): >= 50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extranodal sites.|Up to 390 days|Participants who achieved a response are included in this analysis.|||months||95% Confidence Interval|Median
2539331|NCT03075553|Secondary|Response Rate for Participants Who Achieve a CMR or PMR [PET-CT-based Response]|The response rate for participants who achieve a CMR or PMR is defined as the percentage of participants who achieve a CMR or PMR assessed according to the revised Lugano Classification Response criteria. Complete metabolic response (CMR): Score 1, 2, or 3 with/without a residual mass using the Lugano 5-Point Scale (5-PS). Partial metabolic response (PMR): Score 4 or 5 with reduced update from baseline. The Lugano 5-PS is a scale used for initial staging and assessment of treatment response in Hodgkin lymphoma (HL) and certain types of non-Hodgkin lymphomas (NHL). The scale ranges from 1 to 5, where 1 is best and 5 is the worst. Each FDG-avid (or previously FDG-avid) lesion is rated independently: 1. no uptake or no residual uptake 2. slight uptake, but equal to or below blood pool 3. uptake above mediastinal, but below or equal to uptake in the liver 4. uptake slightly to moderately higher than liver 5. markedly increased uptake or any new lesion (on response evaluation)|Up to 390 days||||percentage of participants||95% Confidence Interval|Number
2539332|NCT03075553|Primary|Response Rate for Participants Who Achieve a CR or PR [CT-based Response]|The response rate for participants who achieve a CR or PR is defined as the percentage of participants who achieve a CR or PR assessed according to the revised Lugano Classification Response criteria. Complete response (CR): target nodes/nodal masses must regress to <=1.5 cm in longest transverse diameter (LDi). Partial response (PR): >= 50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extranodal sites.|Up to 390 days||||percentage of participants||95% Confidence Interval|Number
2539333|NCT03075527|Secondary|Adverse Events|Number of participants with treatment-related adverse events as assessed by CTCAE v4.03.|Toxicity is assessed from the time of first dose of study medication until the participant comes off study. Adverse event profile will be assessed at study completion.||2024-09-30|09/2024||||
2539334|NCT03075527|Secondary|Duration of Response|Time from documentation of tumor response to disease progression|Duration of response will be assessed at study completion, after all participants are off treatment.||2024-09-30|09/2024||||
2539335|NCT03075527|Secondary|Progression Free Survival|Progression-Free Survival (PFS) is defined as the time from randomization (or registration) to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation.|PFS is measured from time of registration to date of radiographic progression per RECIST1.1 or death.||2024-09-30|09/2024||||
2539336|NCT03075527|Secondary|Overall Survival|defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive.|Overall survival is assessed from date of registration until date of death on-treatment or during follow-up.||2024-09-30|09/2024||||
2539337|NCT03075527|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|ORR was assessed every 8 weeks from Cycle 1 Day 1 until date of documented disease progression or death.|19 participants were included in the response rate calculation; one patient received at most one cycle of treatment.|||Participants|||Count of Participants
2539338|NCT03075449|Secondary|The Number of Urinary-symptom Related Visits to Their PCP During the 12 Month Period Prior to Telephone Survey Interview.|The number of urinary-symptom related visits to their primary care provider (PCP) during the 12 month period prior to telephone survey interview.|12 months|FAS|||urinary symptom-related visits||Standard Deviation|Mean
2539339|NCT03075449|Secondary|The Percentage of Men Given Repeat Prescriptions for Their Urinary Symptoms.|"The percentage of men given repeat prescriptions for their urinary symptoms.~95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution."|12 months|FAS|||Percentage of participants||95% Confidence Interval|Number
2539340|NCT03075449|Secondary|The Percentage of Men Given a Prescription for an Alpha-blocker for Their Urinary Symptoms.|"The percentage of men given a prescription for an alpha-blocker for their urinary symptoms.~95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution."|12 months|FAS|||Percentage of participants||95% Confidence Interval|Number
2539341|NCT03075449|Secondary|The Percentage of Men Referred to a Urologist for Their Urinary Symptoms.|"The percentage of men referred to a urologist for their urinary symptoms.~95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution."|12 months|FAS|||Percentage of participants||95% Confidence Interval|Number
2539342|NCT03075449|Secondary|The Percentage of Men Diagnosed With LUTS/BPH (Enlarged Prostate).|"The percentage of men diagnosed with lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) (enlarged prostate).~95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution."|12 months|FAS|||Percentage of participants||95% Confidence Interval|Number
2539496|NCT03070730|Secondary|Change in Physical Functioning- HADS From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Hospital Anxiety and Depression Scales.|1 week after first intervention|||||||
2539345|NCT03075449|Primary|The Percentage of Men Given a Drug Prescription for Their Urinary Symptoms, as Recorded in Their Medical Records|"The percentage of men who have been given at least one prescription medication for urinary symptoms.~This included any medications prescribed by PCP for urinary symptoms according to medical records within 12 months prior to telephone survey as described below:~Medications already prescribed by PCP for urinary symptoms prior to the 1st visit/contact for urinary symptoms within 12 months prior to telephone survey.~Medications newly prescribed by PCP upon visit(s)/contact(s) for urinary symptoms within 12 months prior to telephone survey (i.e., medications prescribed for urinary symptoms on or after the 1st visit/contact).~95% CI was calculated using clopper-pearson estimation method based on the exact binomial distribution."|12 months|Full Analysis Set (FAS): The FAS consists of all enrolled men whose PCP has provided their medical record with at least one urinary symptom recorded between 15 days and 12 months prior to telephone survey interview.|||Percentage of participants||95% Confidence Interval|Number
2539346|NCT03075410|Secondary|Cmax as a Measure of Dose Proportionality of GSK3036656 Following Repeat Dose Administrations for Part B|Blood samples for the assessment of Cmax were collected at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14; and at pre-dose on Days 12 and 13. Cmax following repeat doses was used for assessment of dose proportionality.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14; and at pre-dose on Days 12 and 13|PK Population for Part B|||nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2539347|NCT03075410|Secondary|AUC (0-tau) as a Measure of Dose Proportionality of GSK3036656 Following Repeat Dose Administrations for Part B|Blood samples for the assessment of AUC (0-tau) were collected at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14; and at pre-dose on Days 12 and 13. AUC (0-tau) following repeat doses was used for assessment of dose proportionality.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14; and at pre-dose on Days 12 and 13|PK Population for Part B|||hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2539348|NCT03075410|Secondary|Cmax as a Measure of Dose Proportionality of GSK3036656 Following Single Dose Administrations for Part A|Blood samples for the analysis of Cmax were collected at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. Cmax following single doses was used for assessment of dose proportionality.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period|PK Population for Part A|||hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2539349|NCT03075410|Secondary|AUC (0-t) as a Measure of Dose Proportionality of GSK3036656 Following Single Dose Administrations for Part A|Blood samples for the analysis of AUC (0-t) were collected at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. AUC(0-t) following single doses was used for assessment of dose proportionality.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period|PK Population for Part A|||hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2539350|NCT03075410|Secondary|AUC (0-infinity) as a Measure of Dose Proportionality of GSK3036656 Following Single Dose Administrations for Part A|Blood samples for the analysis of AUC (0-infinity) were collected at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. AUC(0-infinity) following single doses was used for assessment of dose proportionality.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period|PK Population for Part A|||hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2539351|NCT03075410|Secondary|Trough Plasma Concentrations at the End of the Dosing Interval (Ctau) of GSK3036656 Following Repeat Dose Administrations in Part B|Blood samples for the analysis of Ctau were collected at Day 1 (24 hours), Day 12 (Pre-dose ), Day 13 (Pre-dose ), Day 14 (Pre-dose), Day 14 (24 hours). Ctau samples collected were used to assess attainment of steady state. Statistics has been presented on geometric least square means.|Day 1 (24 hours), Day 12 (Pre-dose ), Day 13 (Pre-dose ), Day 14 (Pre-dose), Day 14 (24 hours)|PK Population for Part B|||nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2539352|NCT03075410|Secondary|Steady State Ratio (Rss) of GSK3036656 in Part B|Rss was calculated as Day 14 AUC (0-tau)/Day 1 AUC (0-inf). It was not possible to calculate AUC(0-inf) on Day 1 for the repeat dosing period, therefore it was not possible to calculate the (Rss).Na indicates data was not available.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14|PK Population for Part B|||Ratio of AUC||Geometric Coefficient of Variation|Geometric Mean
2539353|NCT03075410|Secondary|Observed Accumulation Ratio Based on Cmax (RCmax) of GSK3036656 in Part B|Rcmax was calculated as Day 14 Cmax/Day 1 Cmax. Statistics has been presented on geometric least square means.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14|PK Population for Part B|||Ratio of Cmax||Geometric Coefficient of Variation|Geometric Mean
2539354|NCT03075410|Secondary|Observed Accumulation Ratio Based on AUC (AUC [Ro]) of GSK3036656 in Part B|AUC Ro was calculated as Day 14 AUC(0-tau)/Day 1 AUC(0-t), where t and tau= 24 hours.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14|PK Population for Part B|||Ratio of AUC||Geometric Coefficient of Variation|Geometric Mean
2539414|NCT03073876|Secondary|Change in Category Fluency Test|Measure of language / semantic function. This task requires participants to generate words belonging to specific categories within 1 minute. There are three trials. Total scores is computed by obtaining the mean number of words generated across the three trials (fruits/vegetables/animals). Higher score represents better outcome.|Baseline to 6 weeks||||score on a scale||Standard Deviation|Mean
2539355|NCT03075410|Secondary|Tmax of GSK3036656 Following Single Dose Administration in Fed Condition in Part A|Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded. For the food effect assessment, the selected dose was given with a high fat meal.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period|PK Population for Part A|||hours||Full Range|Median
2539356|NCT03075410|Secondary|t1/2 of GSK3036656 Following Single Dose Administration in Fed Condition in Part A|Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded. For the food effect assessment, the selected dose was given with a high fat meal.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period|PK Population for Part A|||hours||Full Range|Median
2539357|NCT03075410|Secondary|Cmax of GSK3036656 Following Single Dose Administration in Fed Condition in Part A|Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded. For the food effect assessment, the selected dose was given with a high fat meal.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period|PK Population for Part A|||nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2539358|NCT03075410|Secondary|AUC (0-infinity) of GSK3036656 Following Single Dose Administration in Fed Condition in Part A|Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded. For the food effect assessment, the selected dose was given with a high fat meal.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period|PK Population for Part A|||hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2539359|NCT03075410|Secondary|AUC (0-t) of GSK3036656 Following Single Dose Administration in Fed Condition in Part A|Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded. For the food effect assessment, the selected dose was given with a high fat meal.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period|PK Population for Part A|||hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2539360|NCT03075410|Primary|t1/2 of GSK3036656 Following Repeated Dose Administration for Part B|Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14. The actual date and time of each blood sample collection was recorded. Results presented are for Day 14.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14.|PK Population for Part B|||hours||Full Range|Median
2539361|NCT03075410|Primary|Tmax of GSK3036656 Following Repeat Dose Administration for Part B|Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14; and at pre-dose on Days 12 and 13. The actual date and time of each blood sample collection was recorded.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14; and at pre-dose on Days 12 and 13|PK Population for Part B|||hours||Full Range|Median
2539362|NCT03075410|Primary|Cmax of GSK3036656 Following Repeated Dose Administration for Part B|Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14; and at pre-dose on Days 12 and 13. The actual date and time of each blood sample collection was recorded.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1; at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14; and at pre-dose on Days 12 and 13|PK Population for Part B|||nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2539363|NCT03075410|Primary|AUC From Time Zero During a Dosing Interval of Duration Tau (AUC[0-tau]) of GSK3036656 Following Repeated Dose Administration for Part B|Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14The actual date and time of each blood sample collection was recorded. Results presented are for Day 14.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 14|PK Population for Part B|||hour*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2539364|NCT03075410|Primary|AUC[0-t] Following Repeated Dose Administration of GSK3036656 for Part B|Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1. The actual date and time of each blood sample collection was recorded. Results presented are for Day 1.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1|PK Population for Part B|||hour*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2539365|NCT03075410|Primary|Apparent Terminal Half-life (t1/2) of GSK3036656 Following Single Dose Administration for Part A|Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period|PK Population for Part A|||hours||Full Range|Median
2539366|NCT03075410|Primary|Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3036656 Following Single Dose Administration for Part A|Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period|PK Population for Part A|||hours||Full Range|Median
2539367|NCT03075410|Primary|Maximum Observed Plasma Drug Concentration (Cmax) of GSK3036656 Following Single Dose Administration for Part A|Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period|PK Population for Part A|||nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2539368|NCT03075410|Primary|AUC From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of GSK3036656 Following Single Dose Administration for Part A|Cmax will be derived from the PK samples collected at the indicated time points Blood samples for plasma PK analysis of GSK3036656 was collected into K3 EDTA tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period|PK Population for Part A|||hour*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2539369|NCT03075410|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]) Following Single Dose Administration of GSK3036656 for Part A|Blood samples for plasma PK analysis of GSK3036656 was collected into K3 Ethylenediaminetetraacetic acid (EDTA) tubes at Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period. The actual date and time of each blood sample collection was recorded. PK population comprised of participants in the Safety population who administered at least one dose of active treatment and had at least one evaluable PK sample.|Pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 15, 24, 36, 48 and 72 hour post-dose on Day 1 in each period|PK Population for Part A|||hour*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2539370|NCT03075410|Primary|Urine pH Analysis by Dipstick Method for Part B|Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by method up to 8 weeks in Part B. Only those participants available at the specified time points were analyzed represented by n=x in the category titles. Period 1 = Cohort 1 in Part B, Period 2 = Cohort 2 in Part B.|Up to 8 weeks|Safety Population for Part B|||pH||Standard Deviation|Mean
2539371|NCT03075410|Primary|Number of Participants With Abnormal Urinalysis Parameters for Part B|Urinalysis included dipstick urine test which was used to screen for glucose, ketones, occult blood and protein up to 14 days post dose The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine glucose, ketones, occult blood and protein can be read as negative, trace, trace-intact, trace-lysed, 1+ and 2+ indicating proportional concentrations in the urine sample. Only categories with non-negative values have been presented. Only those participants available at the specified time points were analyzed represented by n=x in the category titles. Period 1 = Cohort 1 in Part B, Period 2 = Cohort 2 in Part B.|Up to 8 weeks|Safety Population for Part B|||Participants|||Count of Participants
2539372|NCT03075410|Primary|Urine Potential of Hydrogen (pH) Analysis by Dipstick Method for Part A|Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Urine samples were collected for the measurement of urine pH by method up to 72 hours in Part A. Only those participants with data available at the indicated time points were analyzed.|Up to 72 hours post-dose|Safety Population for Part A. For arm Part A-Matching Placebo 3 of the 9 placebo participants received placebo twice, therefore they had these measures done in 2 different treatment periods, so N=9 but number of units analyzed=12.|||pH||Standard Deviation|Mean
2539373|NCT03075410|Primary|Number of Participants With Abnormal Urinalysis Parameters for Part A|Urinalysis included dipstick urine test which was used to screen for glucose, ketones, occult blood and protein up to 72 hours post dose. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine glucose, ketones, occult blood and protein can be read as negative, trace, trace-intact, trace-lysed,1+ and 2+ indicating proportional concentrations in the urine sample. Only categories with non-negative values have been presented. Only those participants with data available the indicated time points were analyzed.|Up to 72 hours post-dose|Safety Population for Part A. For arm Part A-Matching Placebo 3 of the 9 placebo participants received placebo twice, therefore they had these measures done in 2 different treatment periods, so N=9 but number of units analyzed=12.|||Participants|||Count of Participants
2539374|NCT03075410|Primary|Number of Participants With Hematology Parameters of PCI for Part B|Blood samples were collected for the assessment of hematology parameters platelet count, red blood cell count, hemoglobin, hematocrit, reticulocytes, mean corpuscle volume, mean corpuscular hemoglobin, neutrophils, lymphocytes, monocytes, basophils and eosinophils. Only categories with PCI values have been presented.|Up to 8 weeks|Safety Population for Part B|||Participants|||Count of Participants
2539375|NCT03075410|Primary|Number of Participants With Hematology Parameters of PCI for Part A|Blood samples were collected for the assessment of hematology parameters platelet count, red blood cell count, hemoglobin, hematocrit, reticulocytes, mean corpuscle volume, mean corpuscular hemoglobin, neutrophils, lymphocytes, monocytes, basophils and eosinophils. Only categories with PCI values have been presented.|Up to 12 weeks|Safety Population for Part A. For arm Part A-Matching Placebo 3 of the 9 placebo participants received placebo twice, therefore they had these measures done in 2 different treatment periods, so N=9 but number of units analyzed=12.|||Participants|||Count of Participants
2539377|NCT03075410|Primary|Number of Participants With Clinical Chemistry Parameters of PCI for Part A|Blood samples were collected for the assessment of clinical chemistry parameters namely blood urea nitrogen (BUN), creatinine, glucose, cholesterol, potassium, sodium, calcium, aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase, triglycerides, total and direct bilirubin, total protein, albumin and troponin. Only categories with PCI values have been presented, therefore only AST is presented.|Up to 12 weeks|Safety Population for Part A. For arm Part A-Matching Placebo 3 of the 9 placebo participants received placebo twice, therefore they had these measures done in 2 different treatment periods, so N=9 but number of units analyzed=12.|||Participants|||Count of Participants
2539378|NCT03075410|Primary|Number of Participants With Vital Sign Parameter Temperature of PCI for Part B|Number of participants with temperature data of PCI have been presented.|Up to 8 weeks|Safety Population for Part B|||Participants|||Count of Participants
2539379|NCT03075410|Primary|Number of Participants With Vital Sign Parameter Temperature of PCI for Part A|Number of participants with temperature data of PCI have been presented.|Up to 6 weeks|Safety Population for Part A. For arm Part A-Matching Placebo 3 of the 9 placebo participants received placebo twice, therefore they had these measures done in 2 different treatment periods, so N=9 but number of units analyzed=12.|||Participants|||Count of Participants
2539380|NCT03075410|Primary|Number of Participants With Vital Sign Parameter Heart Rate of PCI for Part B|Heart rate was assessed in supine position with a completely automated device. Measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones). The PCI range for heart was less than 40 bpm (lower) and greater than 110 bpm (upper).|Up to 8 weeks|Safety Population for Part B|||Participants|||Count of Participants
2539381|NCT03075410|Primary|Number of Participants With Vital Sign Parameter Heart Rate of PCI for Part A|Heart rate was assessed in supine position with a completely automated device. Measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones). The PCI range for heart was less than 40 bpm (lower) and greater than 110 bpm (upper).|Up to 6 weeks|Safety Population for Part A. For arm Part A-Matching Placebo 3 of the 9 placebo participants received placebo twice, therefore they had these measures done in 2 different treatment periods, so N=9 but number of units analyzed=12.|||Participants|||Count of Participants
2539382|NCT03075410|Primary|Number of Participants With Vital Sign Parameters SBP and DBP of PCI for Part B|SBP and DBP were assessed in supine position with a completely automated device. Measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones). The PCI range for SBP was less than 85 mmHg (lower) and greater than 160 mmHg (upper) while that for DBP was less than 45 mmHg (lower) and greater than 100 mmHg (upper).|Up to 8 weeks|Safety Population for Part B|||Participants|||Count of Participants
2539383|NCT03075410|Primary|Number of Participants With Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) of Potential Clinical Importance (PCI) for Part A|SBP and DBP were assessed in supine position with a completely automated device. Measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones). The PCI range for SBP was less than 85 mmHg (lower) and greater than 160 mmHg (upper) while that for DBP was less than 45 mmHg (lower) and greater than 100 mmHg (upper).|Up to 6 weeks|Safety Population for Part A. For arm Part A-Matching Placebo 3 of the 9 placebo participants received placebo twice, therefore they had these measures done in 2 different treatment periods, so N=9 but number of units analyzed=12.|||Participants|||Count of Participants
2539384|NCT03075410|Primary|Number of Participants With Abnormal Cardiac Telemetry Findings for Part B|Continuous cardiac telemetry was performed from approximately 1 hour pre-dose to 24 hours post dosing . Number of participants who had abnormal findings upon cardiac telemetry assessment have been presented.|25 hours for each period|Safety Population for Part B|||Participants|||Count of Participants
2539385|NCT03075410|Primary|Number of Participants With Abnormal Cardiac Telemetry Findings for Part A|Continuous cardiac telemetry was performed from approximately 1 hour pre-dose to 24 hours post dosing . Number of participants who had abnormal findings upon cardiac telemetry assessment have been presented.|25 hours for each period|Safety Population for Part A. For arm Part A-Matching Placebo 3 of the 9 placebo participants received placebo twice, therefore they had these measures done in 2 different treatment periods, so N=9 but number of units analyzed=12.|||Participants|||Count of Participants
2539386|NCT03075410|Primary|Number of Subjects With Clinically Relevant Changes in ECG in Part B|12-lead ECGs were collected during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT interval and QTcF intervals. At each time point at which triplicate ECGs were required, three individual ECG tracings were obtained as closely as possible in succession, but no more than 2 to 5 minutes apart. ECG findings were categorized as normal, A-NCS and A-CS. Only A-NCS and A-CS worst case post-Baseline values have been presented.|Up to 8 weeks|Safety Population for Part A|||Participants|||Count of Participants
2539387|NCT03075410|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings for Part A|12-lead ECGs were collected during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) intervals. At each time point at which triplicate ECGs were required, three individual ECG tracings were obtained as closely as possible in succession, but no more than 2 to 5 minutes apart. ECG findings were categorized as normal, abnormal not clinically significant (A-NCS) and abnormal clinically significant (A-CS). Only A-NCS and A-CS worst case post-Baseline values have been presented. Only those participants with data available at the indicated time point were analyzed.|Up to 6 weeks|Safety Population for Part A. For arm Part A-Matching Placebo 3 of the 9 placebo participants received placebo twice, therefore they had these measures done in 2 different treatment periods, so N=9 but number of units analyzed=12.|||Participants|||Count of Participants
2539401|NCT03074500|Primary|Patient Rated Tennis Elbow Evaluation (PRTEE)|PRTEE is a 15-item questionnaire designed to measure the forearm pain and disability in patients with LE. PRTEE allows patients to rate their levels of elbow pain and disability from 0 to 10. Test consists of 2 subscales: 1) Pain subscale [5 items] (0 = no pain, 10 = worst imaginable) 2) Function subscale [Specific activities - 6 items, Usual activities - 4 items] (0 = no difficulty, 10 = unable to do). A total score can be computed on a scale of 100 (0 = no disability).|0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)||||units on a scale||Inter-Quartile Range|Median
2539388|NCT03075410|Primary|Number of Participants With nSAE and SAEs for Part B|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above.|Up to 8 weeks|Safety Population for Part B|||Participants|||Count of Participants
2539389|NCT03075410|Primary|Number of Participants With Non-serious Adverse Events (nSAE) and Serious Adverse Events (SAEs) for Part A|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above. Safety Population comprised of all randomized participants who received at least one dose of study medication.|Up to 12 weeks|Safety Population for Part A|||Participants|||Count of Participants
2539390|NCT03075163|Primary|Change in Nausea Score|"Difference in the nausea score before and after treatment. Nausea is scored on a scale from 1 to 10 with 1 being no nausea and 10 being severe nausea with impending vomiting.~A greater difference is indicative of a better outcome"|Time to discharge from post anesthetic care unit||||score on a scale||Standard Error|Mean
2539391|NCT03074682|Other Pre-specified|Post Intervention Survey|A qualitative questionnaire will be administered to participants following the simulation. Questions include information about experience with various methods and other feedback relevant to evaluation. This outcome was included in the registration is actually captured by the NASA Task Load Index (TLX) that was reported.|15 minutes|This outcome is analyzed as the NASA Task Load Index (TLX).||||||
2539392|NCT03074682|Secondary|NASA Task Load Index (TLX)|The NASA Task Load Index (TLX) is a series of measures that capture workload. Each scale employs a visual analog scale that measures each of the domains. The domains are Mental Domain, Physical Demand, Temporal Demand, Performance, Effort and Frustration Level. Each scale domain and the Composite has a range from 0 to 100 with 100 being the highest indicator of workload.|15 minutes||||score on a scale||Inter-Quartile Range|Median
2539393|NCT03074682|Secondary|Time to Complete Fluid Administration|Participants will be timed to determine if they are able to administer 60 mL/kg of fluid within a 20 minute timeframe. The time in which they complete the task will be captured in minutes. The initial registered primary outcome was changed from 60 cc/kg in 15 minutes to its current format before the study began.|Up to 20 minutes||||seconds||Standard Deviation|Mean
2539394|NCT03074682|Primary|Successful Administration of 60 mL/kg|Participants will be timed to determine if they are able to administer 60 mL/kg of fluid within a 20 minute timeframe. This outcome will be measured as a dichotomous 'yes' or 'no' as to whether the task was completed successfully. The initial registered primary outcome was changed from 60 cc/kg in 15 minutes to its current format before the study began.|20 minutes||||Participants|||Count of Participants
2539395|NCT03074500|Secondary|Grip Strength|Grip strength will be measured using a hand held dynamometer (JAMAR, Sammons Preston, Inc., Bolingbrook, IL). Patients will be asked to grip with maximum strength. Three evaluations will be made with resting periods in between and average scores will be recorded.|0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)||||kg||Inter-Quartile Range|Median
2539396|NCT03074500|Secondary|Painless Grip Strength|Grip strength will be measured using a hand held dynamometer (JAMAR, Sammons Preston, Inc., Bolingbrook, IL). Patients will be asked to grip the dynamometer until (s)he feel pain in elbow. Three evaluations will be made with resting periods in between and average scores will be recorded.|0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)||||kg||Inter-Quartile Range|Median
2539397|NCT03074500|Secondary|Visual Analogue Scale (VAS) at Night|Pain on lateral epicondyle at night was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain.|0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)||||score on a scale||Inter-Quartile Range|Median
2539398|NCT03074500|Secondary|Visual Analogue Scale (VAS) at Daily Activity|Pain on lateral epicondyle during daily activity was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain.|0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)||||score on a scale||Inter-Quartile Range|Median
2539399|NCT03074500|Secondary|Visual Analogue Scale (VAS) at Rest|Pain on lateral epicondyle at rest during the day was evaluated with the visual analog scale (VAS 0-10 cm). Higher score indicates more pain.|0. week (Baseline), Immediate Effect (right after first taping in KT and sham taping groups), 2. week (After Treatment) and 6. week (4 weeks After Treatment)||||score on a scale||Inter-Quartile Range|Median
2539400|NCT03074500|Secondary|The Disabilities of the Arm, Shoulder and Hand Score (QuickDash)|The patients will be requested to score from 1 to 5 points any difficulty experienced during different daily activities related to the upper extremity. Test has 1 module of compulsory items and two optional modules: work module (4 items) and sport/performing arts module (4 items). Scores range from 0 to 100, where higher scores indicate more disability.|0. week (Baseline), 2. week (After Treatment), 6. week (4 weeks After Treatment)||||score on a scale||Inter-Quartile Range|Median
2539412|NCT03073876|Secondary|Change in Digit Span Backwards|This measure represents the change in the variable longest Digit Span Backwards (LDSB) from baseline to 6 weeks. Score represents the maximum length of number repeated in the backward condition. Score ranges from 0 to 8. Higher scores represent better outcome.|Baseline to 6 weeks||||units on a scale||Standard Deviation|Mean
2539402|NCT03074409|Primary|Interoceptive Network Activity|interoceptive network (including anterior insula and dorsal cingulate cortex) activity as measured by the functional MRI technique in the heartbeat detection task. In the heartbeat detection task participants were instructed to make a keypress each time they felt their heartbeat. The interoceptive network activity was indicated by the percentage of BOLD signal change. The value of the percentage of BOLD signal change indicates the level of a certain brain region activated (the involvement of a brain region in a specific cognitive process).|45 minutes after oxytocin/placebo treatment|83 subjects were recruited and 8 subjects were excluded due to low quality of electrocardiogram data (6 subjects) or failure of behavioral data acquisition (2 subjects).|||percentage of BOLD signal change||Standard Error|Mean
2539403|NCT03074409|Primary|Heartbeat Detection (Interoception) Accuracy|"heartbeat detection (interoception) accuracy is calculated by the following equation: 1/N ∑ (1 - (|recorded heartbeats - counted heartbeats|)/recorded heartbeats). N was the number of blocks for the heartbeat detection task."|45 minutes after oxytocin/placebo treatment|83 subjects were recruited and 8 subjects were excluded due to low quality of electrocardiogram data (6 subjects) or failure of behavioral data acquisition (2 subjects).|||ratio of correct heartbeat counting||Standard Error|Mean
2539404|NCT03074331|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as the following:~On Treatment Virologic Failure: HCV RNA persistently ≥ LLOQ through 12 weeks of treatment (nonresponse), or~Relapse: HCV RNA ≥ LLOQ at Posttreatment Week 12 having achieved HCV RNA < LLOQ at end of treatment."|Up to Posttreatment Week 12|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2539405|NCT03074331|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to Week 12|Safety Analysis Set included all participants who took at least 1 dose of study drug.|||percentage of participants|||Number
2539406|NCT03074331|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set included all enrolled participants who took at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2539407|NCT03074162|Secondary|Percentage Peak-trough Fluctuation (%PTF), Calculated as [100*(Cmax,ss - Cpre,ss)/Cav,ss]|Percentage peak-trough fluctuation (%PTF) which was calculated as [100*(Cmax,ss - Cpre,ss)/Cav,ss] for Diclofenac. Descriptive statistics by race are reported in addition.|Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration|Pharmacokinetic Population (PK): This population consists of all subjects in the safety population for whom at least one of area under the plasma concentration-time curve over one dosing interval or maximum steady-state plasma drug concentration during a dosage interval could be calculated for one treatment and who had no major protocol deviations.|||Percentage of Cav,ss (%)||Geometric Coefficient of Variation|Geometric Mean
2539408|NCT03074162|Secondary|Average Plasma Concentration (Cav,ss) for Diclofenac at Steady State|Average plasma concentration (Cav,ss) calculated as AUC0-t,ss divided by τ=12 hours (τ is the duration of the dosing interval). Descriptive statistics by race are reported in addition.|Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration|Pharmacokinetic Population (PK): This population consists of all subjects in the safety population for whom at least one of area under the plasma concentration-time curve over one dosing interval or maximum steady-state plasma drug concentration during a dosage interval could be calculated for one treatment and who had no major protocol deviations.|||nanogram/ millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2539409|NCT03074162|Secondary|Time to Maximum Observed Plasma Concentration at Steady State for Diclofenac at Steady State (Tmax,ss) (Day 7)|tmax,ss, Time to maximum observed plasma concentration at steady state for diclofenac at day 7 (tmax,ss). Descriptive statistics by race are reported in addition.|Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration|Pharmacokinetic Population (PK): This population consists of all subjects in the safety population for whom at least one of area under the plasma concentration-time curve over one dosing interval or maximum steady-state plasma drug concentration during a dosage interval could be calculated for one treatment and who had no major protocol deviations.|||Hour (h)||Full Range|Median
2539410|NCT03074162|Primary|Maximum Plasma Concentration During a Dosage Interval (Cmax,ss) Obtained Directly From the Concentration-time Data for Diclofenac at Steady State (Day 7)|Cmax,ss, Maximum plasma of diclofenac concentration during a dosage interval obtained directly from the concentration-time data at steady state for diclofenac on day 7. Stratification by race was analysed using a supportive Analysis of Variance (ANOVA) yielding point estimates for each underlying pairwise comparison analog to the main analysis. As the resulting two Least Square Means and gMeans per treatment and race are very similar, only gMeans per treatment and race are presented.|Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration|Pharmacokinetic Population (PK): This population consists of all subjects in the safety population for whom at least one of area under the plasma concentration-time curve over one dosing interval or maximum steady-state plasma drug concentration during a dosage interval could be calculated for one treatment and who had no major protocol deviations.|||Nanogram/millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2539411|NCT03074162|Primary|Area Under the Plasma Concentration-time Curve (AUC) Over One Dosing Interval for Diclofenac at Steady State (AUC0-τ,ss) (τ = 12 Hours) (Day 7)|AUC0-τ,ss, Area under the plasma concentration-time curve (AUC) over one dosing interval at steady state for diclofenac at day 7 (τ = 12 hours). Stratification by race was analysed using a supportive Analysis of Variance (ANOVA) yielding point estimates for each underlying pairwise comparison analog to the main analysis. As the resulting two Least Square Means and Geometric Means (gMeans) per treatment and race are very similar, only gMeans per treatment and race are presented.|Pharmacokinetic samples were collected on Day 7 at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the drug administration|Pharmacokinetic Population (PK): This population consists of all subjects in the safety population for whom at least one of area under the plasma concentration-time curve over one dosing interval or maximum steady-state plasma drug concentration during a dosage interval could be calculated for one treatment and who had no major protocol deviations.|||Hour*nanogram/millilitre (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2539416|NCT03073876|Secondary|Change on Trail Making Test - Condition|The Delis-Kaplan Executive Function (D-KEFS Trail) Subtest 4: Number-Letter Switching Scaled Score was used to assess executive functioning. Scaled scores range from 1-19. Higher scores represent less impairment (below 8 = low; 8-12 = average; > 12 = above average). Scores represent seconds to complete the task. Faster performance is better.|Baseline to 6 weeks||||units on a scale||Standard Deviation|Mean
2539417|NCT03073876|Secondary|Change in Language Function Assessed With the Letter Fluency Test|Letter fluency (FAS) (Benton, 1967) was selected to assess speed of verbal generativity. Participants are required to generate words that start with a particular letter (excluding n; three trials (words starting with 'F', 'A', 'S' each for 1 minute minutes) are administered. Higher performance is better with range from 0 to unlimited.|Baseline to 6 weeks||||score on a scale||Standard Deviation|Mean
2539418|NCT03073876|Secondary|Change in Hopkins Verbal Learning Test- Revised - Recall|Hopkins Verbal Learning Test- Revised (HVLT-R) (Brandt, 1991) is a list-learning task. Recall variable is computed by adding the number of words repeated in each of the three learning trials. Raw scores of each measure were used in the analyses. Total Recall ranges from 0-30. Higher scores represent better outcome.|Baseline to 6 weeks||||score on a scale||Standard Deviation|Mean
2539419|NCT03073876|Secondary|Change in Digit Span Forward|This measure represents the change in the variable longest Digit Span Forward (LDSF) from baseline to 6 weeks. Score represents the maximum length of number repeated in the forward condition. Score ranges from 0 to 9. Higher scores represent better outcome.|Baseline to 6 weeks||||units on a scale||Standard Deviation|Mean
2539420|NCT03073876|Secondary|Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)|Change of Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog); primary outcome measure of drug efficacy. Minimum value = 0, maximum value = 70. Higher scores represent worse cognitive functioning.|Baseline to 6 weeks||||score on a scale||Standard Deviation|Mean
2539421|NCT03073876|Secondary|Mini Mental Status Examination|Mini Mental Status Examination (MMSE) is a commonly used cognitive screener. Scores range from 0-30; higher scores mean better cognitive functioning.|Baseline to 6 weeks||||units on a scale||Standard Deviation|Mean
2539422|NCT03073876|Secondary|Change in Dementia Rating Scale|Dementia Rating Scale (DRS) change score (performance at 6 weeks minus performance at baseline). This is a global measure of cognitive function. Scores range from 0 - 144; higher scores represent better cognitive functioning.|Baseline to 6 weeks||||units on a scale||Standard Deviation|Mean
2539423|NCT03073876|Primary|Neuropsychiatric Inventory Score|Neuropsychiatric Inventory (NPI) is a scale that measures neuropsychiatric symptoms. We reported a score that captures the frequency of each symptom multiplied by the severity rating score. Scores range from 0 - 144; Higher scores represent worse outcomes.|6 months||||score on a scale||Standard Deviation|Mean
2539424|NCT03073876|Primary|Covert Orienting at 6 Weeks - Fatigue Across Blocks|Computerized attention task measures response time to detect a target across blocks of stimuli. Data shown for performance at Block1 and Block5|6 weeks||||msec||Standard Deviation|Median
2539425|NCT03073876|Primary|Change in Foreperiod Effect Task - Variability (350ms & 500ms)|Computerized attention task measures the variability (SD) in response time to detect a target presented at varied interstimulus intervals (350ms and 500ms)|Baseline to 6 weeks||||msec||Standard Deviation|Mean
2539426|NCT03073876|Primary|Foreperiod Effect Task at 6 Weeks - Fatigue (Blocks 1 & 2)|Computerized attention task measures reaction time (RT) to detect a target presented at varied interstimulus interval comparing Block 1 (presented at beginning of session) and Block 2 (presented at end of session)|6 weeks||||msec||Standard Deviation|Median
2539427|NCT03073876|Primary|Change of ADAS-COG From Baseline to 6 Months|Change of Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog); primary outcome measure of drug efficacy. Minimum value = 0, maximum value = 70. Higher scores represent worse cognitive functioning.|Baseline to 6 months||||units on a scale||Standard Deviation|Mean
2539428|NCT03073876|Primary|Change in Attentional Blink Task Baseline to 6 Weeks - SOA 399ms|Computerized attention task measures the accuracy of reporting stimuli presented within 399 ms interval. Higher accuracy represents better performance.|Baseline to 6 weeks||||milliseconds||Standard Deviation|Mean
2539429|NCT03073876|Primary|Change in Attentional Blink Task Baseline to 6 Weeks - Stimulus Onset Asynchrony (SOA) 266ms|Computerized attention task measures the accuracy of reporting stimuli presented at time intervals, varying load. Faster reaction time and accuracy represents better performance.|Baseline to 6 weeks||||milliseconds||Standard Deviation|Mean
2539430|NCT03073876|Primary|Change in Covert Orienting Task|Computerized attention task measuring response time to detect a target after a spatial orienting cues of either valid (cue on same side in space as target) or Invalid Cue (cue on opposite side of space as target). Longer response time (msec) indicates worse performance.|Baseline to 6 weeks||||milliseconds||Inter-Quartile Range|Median
2539431|NCT03073876|Primary|Change in Foreperiod Effect Task - Processing Speed|Computerized attention task measures response time to detect a target presented at varied interstimulus intervals (350ms and 500ms). Participants respond to centrally presented asterisk on computer screen. Time elapsed from prior stimulus (= interstimulus interval) indicates when prior stimulus was presented. xx|Baseline to 6 weeks||||response time in msec||Standard Deviation|Median
2539432|NCT03073798|Primary|Difference in Mucociliary Clearance (MCC) Between Visit 1B and Visit 2B|"Measurements of MCC (Mucociliary clearance) will be obtained using a large-field-of-view 2D gamma camera (Siemens Orbiter) following inhalation of a radioaerosol containing a gamma emitting isotope 99mtechnetium (99mTc)-sulfur-colloid. The total exposure to radiation from procedures associated with the MCC studies is similar to that of a chest x-ray and is much less than the 0.3 rem that the average person in the United States gets each year from natural sources like the sun, outer space, air, food, and soil.~After inhaling (0 time point) an aerosol generated from a saline solution containing the radioisotope 99mtechnetium (99mTc)-sulfur-colloid (radioaerosol), subjects will sit with their back to a gamma camera. The gamma camera will acquire an image of where the isotopic marker initially deposits in the right lung at time 0 and how much remains in the lungs at the specified time point and will be measured in change of %/min from 0 min time point."|Change from 0 min to 24 hours|Data was not collected for all participants in this outcome measure due to lack of follow-up, patient withdrawal from the study, and an adverse event.|||percentage difference of MCC||Standard Deviation|Mean
2539433|NCT03073798|Primary|Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A|"Measurements of MCC (Mucociliary clearance) will be obtained using a large-field-of-view 2D gamma camera (Siemens Orbiter) following inhalation of a radioaerosol containing a gamma emitting isotope 99mtechnetium (99mTc)-sulfur-colloid. The total exposure to radiation from procedures associated with the MCC studies is similar to that of a chest x-ray and is much less than the 0.3 rem that the average person in the United States gets each year from natural sources like the sun, outer space, air, food, and soil.~After inhaling (0 time point) an aerosol generated from a saline solution containing the radioisotope 99mtechnetium (99mTc)-sulfur-colloid (radioaerosol), subjects will sit with their back to a gamma camera. The gamma camera will acquire an image of where the isotopic marker initially deposits in the right lung at time 0 and how much remains in the lungs at the specified time point and will be measured in change of %/min from 0 min time point."|Change from 0 to 90 minutes|Data was not collected for all participants in this outcome measure due to lack of follow-up, patient withdrawal from the study, and an adverse event.|||percentage difference of MCC||Standard Deviation|Mean
2539434|NCT03073798|Primary|Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A|"Measurements of MCC (Mucociliary clearance) will be obtained using a large-field-of-view 2D gamma camera (Siemens Orbiter) following inhalation of a radioaerosol containing a gamma emitting isotope 99mtechnetium (99mTc)-sulfur-colloid. The total exposure to radiation from procedures associated with the MCC studies is similar to that of a chest x-ray and is much less than the 0.3 rem that the average person in the United States gets each year from natural sources like the sun, outer space, air, food, and soil.~After inhaling (0 time point) an aerosol generated from a saline solution containing the radioisotope 99mtechnetium (99mTc)-sulfur-colloid (radioaerosol), subjects will sit with their back to a gamma camera. The gamma camera will acquire an image of where the isotopic marker initially deposits in the right lung at time 0 and how much remains in the lungs at the specified time point and will be measured in change of %/min from 0 min time point."|Change from 0 to 60 minutes|Data was not collected for all participants in this outcome measure due to lack of follow-up, patient withdrawal from the study, and an adverse event.|||percentage difference of MCC||Standard Deviation|Mean
2539435|NCT03073798|Primary|Difference in Mucociliary Clearance (MCC) Between Visit 1A and Visit 2A|"Measurements of MCC (Mucociliary clearance) will be obtained using a large-field-of-view 2D gamma camera (Siemens Orbiter) following inhalation of a radioaerosol containing a gamma emitting isotope 99mtechnetium (99mTc)-sulfur-colloid. The total exposure to radiation from procedures associated with the MCC studies is similar to that of a chest x-ray and is much less than the 0.3 rem that the average person in the United States gets each year from natural sources like the sun, outer space, air, food, and soil.~After inhaling (0 time point) an aerosol generated from a saline solution containing the radioisotope 99mtechnetium (99mTc)-sulfur-colloid (radioaerosol), subjects will sit with their back to a gamma camera. The gamma camera will acquire an image of where the isotopic marker initially deposits in the right lung at time 0 and how much remains in the lungs at the specified time point and will be measured in change of %/min from 0 min time point."|Change from 0 to 30 minutes|Data was not collected for all participants in this outcome measure due to lack of follow-up, patient withdrawal from the study, and an adverse event.|||percentage difference of MCC||Standard Deviation|Mean
2539436|NCT03073486|Primary|Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12|"Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12~Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions~- Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion~- Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions)~- Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion~- Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions"|Baseline and Week 12|Intent-to-Treat|||Participants|||Count of Participants
2539437|NCT03073486|Primary|Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12|Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12|Baseline and Week 12|Intent-to-Treat|||Lesions||Standard Deviation|Least Squares Mean
2539438|NCT03073486|Primary|Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12|Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12|Baseline and Week 12|Intent-to-Treat|||Lesions||Standard Deviation|Least Squares Mean
2539439|NCT03073200|Secondary|Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Etanercept Approved Countries)|Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.|Week 12|"All randomized participants in Etanercept approved countries per protocol addendum. Missing values were imputed by Nonresponder imputation.~Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis."|||percentage of participants|||Number
2539440|NCT03073200|Secondary|Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Etanercept Approved Countries)|"PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%.~Overall score ranges from 0 (no psoriasis) to 72 (most severe disease)."|Week 12|"All randomized participants in Etanercept approved countries per protocol addendum. Missing values were imputed by Nonresponder imputation.~Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis."|||percentage of participants|||Number
2539443|NCT03073200|Secondary|Change From Baseline on the Palmoplantar Psoriasis Severity Index (PPASI)|"PPASI was used if the participant has palmoplantar psoriasis at baseline. Both the palms & soles on each hand & foot was assessed for erythema, induration, desquamation & percentage of area affected as follows:~Erythema (E), Induration (I), & Desquamation (D):0 = None, 1 = Slight, 2 = Moderate, 3 = Severe, 4 = Very Severe~Percent of Palm and Sole Area Covered:~0 = None, 1 = <10%, 2 = 10% - 29%, 3 = 30% - 49%, 4 = 50% - 69%, 5 = 70% - 89%, 6 = 90% - 100% PPASI score is a composite score derived from the sum scores for E, I, & D multiplied by a score for the extent of palm & sole area involvement. The range is 0 (no psoriasis) to 72 (most severe disease)."|Baseline, Week 12|"All randomized participants with baseline PPASI score in placebo and Ixekizumab arms.~LSMean was calculated using MMRM model with treatment, region, baseline sPGA score, baseline weight category, baseline value, visit, treatment-by-visit, and baseline-by-visit interactions as fixed factors."|||score on a scale||Standard Error|Least Squares Mean
2539444|NCT03073200|Secondary|Change From Baseline on the Psoriasis Scalp Severity Index (PSSI)|"The scalp was assessed for erythema (redness), induration (hardness), and desquamation (shedding of skin) and percentage of area affected as follows:~Erythema, Induration and Desquamation:~0 = Absent~= Slight~= Moderate~= Severe~= Severest Possible~Percent of Scalp Involved:~= <10%~= 10% - 29%~= 30% - 49%~= 50% - 69%~= 70% - 89%~= 90% - 100%~The PSSI score is a composite score derived from the sum of the scores for erythema, induration and desquamation multiplied by the score for the extent of scalp area involved (percent of scalp involved). The range is 0 (no psoriasis) to 72 (Most severe Disease).~LSMean was calculated using treatment, region, baseline sPGA score, baseline weight category, baseline value, visit, treatment-by-visit, and baseline-by-visit interactions as fixed factors."|Baseline, Week 12|"All randomized participants with baseline and post-baseline PSSI score in placebo and Ixekizumab.~LSMean was calculated using MMRM model with treatment, region, baseline sPGA score, baseline weight category, baseline value, visit, treatment-by-visit, and baseline-by-visit interactions as fixed factors."|||score on a scale||Standard Error|Least Squares Mean
2539445|NCT03073200|Secondary|Change From Baseline on the Nail Psoriasis Severity Index (NAPSI)|"NAPSI is a numeric, reproducible, objective tool for evaluation of nail psoriasis. This scale was used to evaluate the severity of nail bed psoriasis & nail matrix psoriasis by area of involvement in the nail unit. Both fingernail & toenail involvement were assessed.The nail is divided with imaginary horizontal & longitudinal lines into quadrants. Each nail is given a score for nail bed psoriasis (0 to 4) & nail matrix psoriasis (0 to 4), depending on the presence (score of 1) or absence (score of 0) of any of the features of nail bed & nail matrix psoriasis in each quadrant:~0 = None~= present in one quadrant of nail~= present in two quadrants of nail~= present in three quadrants of nail~= present in four quadrants of nail NAPSI score of a nail is the sum of scores in nail bed & nail matrix from each quadrant (maximum of 8). Each nail is evaluated, & the sum of all the fingernails and toenails is the total NAPSI score ranging from 0 to 160 (No to Severe nail Psoriasis)"|Baseline, Week 12|"All randomized participants with baseline and post baseline NAPSI score in placebo and Ixekizumab arms.~Least squares(LS) Mean was calculated using mixed model repeated measures (MMRM) with treatment, region, baseline sPGA score,baseline weight category, baseline value, visit, treatment-by-visit, & baseline-by-visit interactions as fixed factors."|||score on a scale||Standard Error|Least Squares Mean
2539446|NCT03073200|Secondary|Percentage of Participants Achieving Children's Dermatology Life Quality Index (CDLQI)/Dermatology Life Quality Index (DLQI) (0/1)|"DLQI is a validated, dermatology-specific, patient reported measure that evaluates participant's health-related quality of life. It consists of 10 items that are grouped in 6 domains: symptoms & feelings, daily activities, leisure, work & school , personal relationships, & treatment. The recall period of this scale is over the last week. Response categories and corresponding scores are:~Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0. A DLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment). CDLQI questionnaire is designed for use in children (4 to 16 years of age). It consists of 10 items that are grouped into 6 domains: symptoms & feelings, leisure, school or holidays, personal relationships, sleep, & treatment. A CDLQI total score is calculated by summing all 10 items responses, and has a range of 0 to 30 (higher scores are indicative of greater impairment)."|Week 12|"All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation.~Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis."|||percentage of participants|||Number
2539447|NCT03073200|Secondary|Percentage of Participants With an Improvement of ≥4 in Those Who Had a Baseline Itch Numeric Rating Scale (NRS) Score of ≥4|"Itch Numeric Rating Scale (NRS): is a single-item, patient-reported outcome (PRO) measure designed to capture the overall severity of a participant's itching due to his/her psoriasis by having the patient circle the integer that describes the worst level of itching in the past 24 hours on an 11-point NRS anchored at 0 representing no itching and 10 representing worst itch imaginable."|Week 12|"All randomized participants with baseline Itch NRS Score >=4 in placebo and Ixekizumab arms.~Missing values were imputed by NRI. Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis."|||percentage of participants|||Number
2539448|NCT03073200|Secondary|Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1)|Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.|Week 4|"All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation.~Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis."|||percentage of participants|||Number
2539466|NCT03071276|Primary|Complete Response or Complete Response With Incomplete Count Recovery|Complete response or complete response with incomplete count recovery, of selinexor in combination with fludarabine and cytarabine for patients with relapsed or refractory AML in the phase II portion of the study|Between days 28 and 35 of cycle 1 (cycle length is 42-56 days)|Patients with response data available|||percentage of participants||95% Confidence Interval|Number
2539449|NCT03073200|Secondary|Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)|PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).|Week 4|"All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation.~Pts who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis."|||percentage of participants|||Number
2539450|NCT03073200|Secondary|Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)|"PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%.~Overall score ranges from 0 (no psoriasis) to 72 (most severe disease)."|Week 12|"All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation.~Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis."|||percentage of participants|||Number
2539451|NCT03073200|Secondary|Percentage of Participants With a sPGA (0)|"Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.~An sPGA assessed as 0 represents a clinically important endpoint indicating complete resolution of plaque psoriasis."|Week 12|"All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation.~Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis."|||percentage of participants|||Number
2539452|NCT03073200|Secondary|Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)|PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total BSA affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%.Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).|Week 12|"All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation.~Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis."|||percentage of participants|||Number
2539453|NCT03073200|Primary|Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Placebo and Ixekizumab)|Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.|Week 12|"All randomized participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation(NRI).~Pts who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis."|||percentage of participants|||Number
2539454|NCT03073200|Primary|Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Placebo and Ixekizumab)|"PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total body surface area (BSA) affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = >0% to <10%, 2 = 10% to <30%, 3 = 30% to <50%, 4 = 50% to <70%, 5 = 70% to 90%, 6 = 90% to 100%.~Overall score ranges from 0 (no psoriasis) to 72 (most severe disease)."|Week 12|"All randomized Participants in placebo and Ixekizumab arms. Missing values were imputed by Nonresponder imputation.~Participants who do not meet the clinical response criteria or have missing clinical response data or without at least 1 post-baseline observation are considered as nonresponders for NRI analysis."|||percentage of participants|||Number
2539467|NCT03071276|Primary|Complete Response|Complete response, of selinexor in combination with fludarabine and cytarabine for patients with relapsed or refractory AML in the phase II portion of the study|Between days 28 and 35 of cycle 1 (cycle length is 42-56 days)|Patients with response data available|||percentage of participants||95% Confidence Interval|Number
2539468|NCT03071276|Primary|The Overall Response (OR) Rate (Complete Response + Incomplete Count Recovery + Partial Response)|Complete response or complete response with incomplete count recovery or partial response, of selinexor in combination with fludarabine and cytarabine for patients with relapsed or refractory AML in the phase II portion of the study|Between days 28 and 35 of cycle 1 (cycle length is 42-56 days)|Patients with response data available|||percentage of participants||95% Confidence Interval|Number
2539455|NCT03072875|Primary|Number of ED Patient Participants Who Completed Semi-Structured Interview|"A semi-structured interview was conducted following use of the CAMS-RAS tool to assess users' likes, dislikes, and other preferences. Questions included: What were your experiences in using 'Dr. Dave' and the CAMS-RAS system? and What suggestions would you have for improvement? All subjects indicated that they found the tool helpful to them. They described the tool using adjectives similar to those used to describe Nurse Louise - a discharge nurse avatar on which the investigator's avatar was based: He's kind and asks me really practical, helpful questions; He speaks to me directly in a compassionate way; and He is kind and invested."|After interacting with the technology (length: approximately 1 hour), subjects were then asked to complete the semi-structured interview conducted by the research assistant. On average, the interview lasted approximately 15 minutes.|The qualitative information from the semi-structured interviews tells us subjects' general opinions and preferences concerning the avatar.|||Participants|||Count of Participants
2539456|NCT03072875|Primary|Usability Satisfaction and Acceptability Questionnaire (USAQ)|A brief face-valid, self-report measure that the PI derived from the System Usability Scale and has been successfully used in previous studies. Items are rated on a 5-point Likert Scale (1=poor; 3=good; 5=excellent). Includes open-ended questions to better understand what was most and least helpful with respect to each category and also measures users' acceptance.|up to one day|Suicidal ED Patients only|||units on a scale||Standard Deviation|Mean
2539457|NCT03072719|Secondary|Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14|Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.|Baseline, post first brushing (after 5 minutes), Day 3 and Day 14|Analysis for this outcome was conducted on ITT population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time points for treatment arms respectively.|||gram (g)||Standard Deviation|Mean
2539458|NCT03072719|Secondary|Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3|Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, post first brushing (after 5 minutes) and Day 3|Analysis for this outcome was conducted on ITT population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time points for treatment arms respectively.|||score on a scale||Standard Deviation|Mean
2539459|NCT03072719|Primary|Change From Baseline in Schiff Sensitivity Score on Day 14|Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.|Baseline, Day 14|Analysis for this outcome was conducted on intent-to-treat (ITT) population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time point for treatment arms respectively.|||score on a scale||Standard Deviation|Mean
2539460|NCT03072550|Primary|Mycological Cure|mycological cure defined as two consecutive negative cultures per FDA guideline|2 cultures taken a week apart within 2 weeks after the first treatment||||Participants|||Count of Participants
2539461|NCT03071887|Primary|Participant Satisfaction With Study Procedures|"Acceptability will be assessed using scores on the Client Satisfaction Questionnaire (CSQ-8). Response options as follows, Very satisfied, Mostly satisfied, Indifferent or mildly dissatisfied, and Quite dissatisfied."|Approximately 10 weeks after baseline||||Participants|||Count of Participants
2539462|NCT03071887|Primary|Number of Participants Completing Treatment Sessions|The investigators will assess feasibility by collecting data on the number of completed treatment sessions.|Approximately 10 weeks after baseline||||Participants|||Count of Participants
2539463|NCT03071744|Secondary|Number of Participants With Adverse Effects Associated With Lazanda|evaluate adverse effects associated with Lazanda use utilizing the NCI CTCAE version 4.03 before and after palliative radiation.|4-5 weeks of patient participation in the study||||Participants|||Count of Participants
2539464|NCT03071744|Secondary|Participants With Change in Patient Reported Positional Pain Severity Via the Brief Pain Inventory Short Form|Assess change in patient reported pain severity using the Brief Pain Inventory Short Form (BPI-sf).|from the time of laying down on the hard surface (0 minutes) to 15 minutes after laying down at each fractionation visit.||||Participants|||Count of Participants
2539465|NCT03071744|Primary|Number of Participants With Change in Patient Reported Positional Pain Intensity|Assess the change in patient reported positional pain intensity (PI) as measured by an 11-point numerical rating scale zero (no pain) to ten (severe pain) (NRS-11; scores on a scale) in cancer patients with bone metastases assessed at each daily palliative radiation fraction. Our primary objective will be measured using the pain intensity difference (PID) of the NRS-11 between 0 minutes and 15 minutes after laying down on the hard surface (PID15= PI0- PI15).|0 minutes and 15 minutes after laying down on the hard surface (PID15= PI0- PI15).||||Participants|||Count of Participants
2539482|NCT03070730|Secondary|Change in Physical Functioning-EuroQOL From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the EuroQOL.|1 week after third intervention|||||||
2539469|NCT03071263|Post-Hoc|Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications|"Row Titles:~AM: Antihypertensive Medication(s)~New AM: Participants who required additional new antihypertensive medication(s)~Increases to baseline AM: Participants who required increases to baseline antihypertensive medication(s)~Addition new (or increase) AM: Participants who required addition of new antihypertensive medication(s) and/or increases to baseline antihypertensive medications~At any time during the study: During study~While on study medication: On medication"|From baseline to Week 12/Early Termination visit|Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.|||participants|||Number
2539470|NCT03071263|Other Pre-specified|Spironolactone Dose Level at End of 12 Weeks of Study Treatment|"Row title:~Participants not completing 12W of study treatment: Participants who had not completed 12 weeks of study treatment."|12 Weeks of Study Treatment|Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.|||Participants|||Count of Participants
2539471|NCT03071263|Other Pre-specified|Shifts in Selected Laboratory Tests From Baseline to End of Treatment|"The end of treatment value is defined as the last non-missing value on or prior to the last spironolactone dose date (from End of Treatment - Case report form) + 3 days~LLN=Lower limit of the normal range. ULN=Upper limit of the normal range. EoT=End of Treatment"|From Baseline to End of Treatment, up to 12 weeks.|Safety Population|||participants|||Number
2539472|NCT03071263|Other Pre-specified|Number of Participants by Spironolactone Dose Prescribed at Each Visit|"QD: Once daily~QOD: Once every other day"|From baseline to Week 10|Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.|||Participants|||Count of Participants
2539473|NCT03071263|Other Pre-specified|Participants Having Spironolactone Titrations Over Time|"The titration was performed according to the following criteria: Spironolactone was increased in cases of hypertension, decreased or stopped in cases of hypotension and maintained if the blood pressure results were adequate~The symbols > and ≤ included in the row titles are used to indicate the time interval [>Week1 and ≤Week2 meaning from day 8 until day 14 (included)]."|From baseline to Week 12|"Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.~Reported results only include the number of participants having spironolactone titrations over time according to the classification defined below."|||Participants|||Count of Participants
2539474|NCT03071263|Other Pre-specified|Participants With Central Serum Potassium <5.5 mEq/L Over Time|"Baseline Central Serum Potassium: BCSP.~The symbols > and ≤ included in the row titles are used to indicate the time interval [>Week1 and ≤Week2 meaning from day 8 until day 14 (included)].~If a participant's serum potassium result at baseline was not in one of the two subgroups reported below, the participant's potassium stratum at randomization was used. Therefore, participants with BCSP <4.3 mEq/L or >5.1 mEq/L at baseline (Day 0) have been classified according to their serum potassium values at the Screening period."|From baseline to Week 12|"Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.~Table depicts those participants with values at mentioned time frame. Those participants with no available results were not included in the table below."|||Participants|||Count of Participants
2539475|NCT03071263|Other Pre-specified|Central Serum Potassium Change From Baseline to Week 12 by Baseline Serum Potassium Category|"The two baseline potassium subgroups, 4.3-<4.7 mEq/L versus 4.7-5.1 mEq/L, are based on central laboratory data.~If a participant's serum potassium result at baseline was not in one of the two subgroups reported below, the participant's potassium stratum at randomization was used. Therefore, participants with BCSP <4.3 mEq/L or >5.1 mEq/L at baseline (Day 0) have been classified according to their serum potassium values at the Screening period."|From baseline to Week 12|"Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.~Table depicts those participants with values at Baseline and Week 12. Those participants with no available results at W12 were not included in the table below."|||mEq/L||Standard Deviation|Mean
2539476|NCT03071263|Other Pre-specified|Change in AOBP SBP From Baseline to Week 12 Regardless of Increase in Antihypertensives|AOBP SBP: Automated Office Systolic Blood Pressure|From baseline to Week 12|Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.|||mmHg||Standard Deviation|Mean
2539477|NCT03071263|Secondary|Change in AOBP SBP From Baseline to Week 12 or Last Available AOBP SBP Prior to Addition of Any New BP Medications or Increase From Any Baseline BP Medications|AOBP: Automated Office Blood Pressure SBP: Systolic Blood Pressure BP: Blood Pressure|From baseline to Week 12|Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.|||mmHg||Standard Deviation|Mean
2539478|NCT03071263|Primary|Number of Participants Remaining on Spironolactone at Week 12|The proportion of subjects remaining on spironolactone at Week 12 will be compared between treatment groups (spironolactone/patiromer versus spironolactone/placebo). Subjects who discontinued from the study early or discontinued study spironolactone prior to Week 12, for any reason, were considered as not having remained on spironolactone until Week 12.|At week 12|Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo.|||Participants|||Count of Participants
2539479|NCT03070730|Secondary|Change in Physical Functioning-OI From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Orthostatic Intolerance Questionnaire.|1 week after third intervention|||||||
2539480|NCT03070730|Secondary|Change in Physical Functioning-OI From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Orthostatic Intolerance Questionnaire.|1 week after second intervention|||||||
2539481|NCT03070730|Secondary|Change in Physical Functioning-OI From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the Orthostatic Intolerance Questionnaire.|1 week after first intervention|||||||
2539497|NCT03070730|Secondary|Change in Physical Functioning- 7 Item Patient Global Impression of Change From Baseline|"Measures of follow up testing will be the scores on the physical functioning subscale of the 7 item patient global impression of change with items anchored by :very much better to very much worse."|1 week after third intervention|||||||
2539498|NCT03070730|Secondary|Change in Physical Functioning- 7 Item Patient Global Impression of Change From Baseline|"Measures of follow up testing will be the scores on the physical functioning subscale of the 7 item patient global impression of change with items anchored by :very much better to very much worse."|1 week after second intervention|||||||
2539499|NCT03070730|Secondary|Change in Physical Functioning- 7 Item Patient Global Impression of Change From Baseline|"Measures of follow up testing will be the scores on the physical functioning subscale of the 7 item patient global impression of change with items anchored by :very much better to very much worse."|1 week after first intervention|||||||
2539500|NCT03070730|Secondary|Change in Physical Functioning-SF-36 Q From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the SF-36 questionnaire.|1 week after third intervention|||||||
2539501|NCT03070730|Secondary|Change in Physical Functioning-SF-36 Q From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the SF-36 questionnaire.|1 week after second intervention|||||||
2539502|NCT03070730|Secondary|Change in Physical Functioning-SF-36 Q From Baseline|Measures of follow up testing will be the scores on the physical functioning subscale of the SF-36 questionnaire.|1 week after first intervention|||||||
2539503|NCT03070730|Secondary|Change in Muscle Sympathetic Nerve Activity From Baseline||1 week after third intervention|||||||
2539504|NCT03070730|Secondary|Change in Muscle Sympathetic Nerve Activity From Baseline||1 week after second intervention|||||||
2539505|NCT03070730|Secondary|Change in Muscle Sympathetic Nerve Activity From Baseline||1 week after first intervention|||||||
2539506|NCT03070730|Secondary|Change in Vascular Resistance From Baseline||1 week after third intervention|||||||
2539507|NCT03070730|Secondary|Change in Vascular Resistance From Baseline||1 week after second intervention|||||||
2539508|NCT03070730|Secondary|Change in Vascular Resistance From Baseline||1 week after first intervention|||||||
2539509|NCT03070730|Secondary|Change in Heart Rate From Baseline||1 week after third intervention|||||||
2539510|NCT03070730|Secondary|Change in Heart Rate From Baseline||1 week after second intervention|||||||
2539511|NCT03070730|Secondary|Change in Heart Rate From Baseline||1 week after first intervention|||||||
2539512|NCT03070730|Secondary|Change in Blood Pressure From Baseline||1 week after third intervention|||||||
2539513|NCT03070730|Secondary|Change in Blood Pressure From Baseline||1 week after second intervention|||||||
2539514|NCT03070730|Secondary|Change in Blood Pressure From Baseline||1 week after first intervention|||||||
2539515|NCT03070730|Primary|Change in Fatigue Score on the Chalder Fatigue Questionnaire From Baseline|A 14 item self-report questionnaire. Subjects respond on a continuum of 1 to 4 questions evaluating fatigue intensity while distinguishing physical from mental fatigue.|2 weeks after second intervention|||||||
2539516|NCT03070730|Primary|Change in Fatigue Score on the Chalder Fatigue Questionnaire From Baseline|A 14 item self-report questionnaire. Subjects respond on a continuum of 1 to 4 questions evaluating fatigue intensity while distinguishing physical from mental fatigue.|2 weeks after first intervention|||||||
2539517|NCT03070730|Primary|Change in Fatigue Score on the Chalder Fatigue Questionnaire From Baseline|A 14 item self-report questionnaire. Subjects respond on a continuum of 1 to 4 questions evaluating fatigue intensity while distinguishing physical from mental fatigue.|up to 3 days after randomization|||||||
2539518|NCT03070730|Primary|Change Maximal Postural Tachycardia During Tilt|Maximal postural tachycardia is the maximum heart rate during a 20-min tilt table test.|2 weeks after second intervention|||||||
2539519|NCT03070730|Primary|Change Maximal Postural Tachycardia During Tilt|Maximal postural tachycardia is the maximum heart rate during a 20-min tilt table test.|2 weeks after first intervention|||||||
2539520|NCT03070730|Primary|Change in Maximal Postural Tachycardia During Tilt|Maximal postural tachycardia is the maximum heart rate during a 20-min tilt table test.|Up to 3 days after randomization|||||||
2539521|NCT03070548|Secondary|Amount of Any Significant Metabolites of Talazoparib in Urine and Feces|M4 (M481/1, cysteine conjugate of mono-desfluoro-talazoparib) metabolite was found in urine. MDV10595 (M1, dehydrogenated talazoparib (PF-07052386), M556/1 (glucuronide conjugate of talazoparib), and M2 (M396/1, mono-oxidative talazoparib) metabolites were calculated together and were also found in urine. Three metabolites named as: MDV10595 (M1)/M556/1 and M2 (M396/1) which were calculated together were detected in feces. Amount of metabolite in this outcome measure was measured in terms of percentage of dose of talazoparib.|From 0 to 8 hrs, 8 to 24 hrs, 24 to 48 hrs and then after every 24 hrs until up to 504 hrs post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||percentage of dose|||Number
2539522|NCT03070548|Secondary|Number of Participants With Change From Baseline in Physical Examination Findings|Physical examination included examination of abdomen, cardiovascular, eyes, ears, nose, throat, general appearance, head, neck, thyroid, lymph nodes, musculoskeletal, neurological, skin/subcutaneous tissue and thorax/lungs.|Baseline up to Day 22|Safety population set included all participants who received at least 1 dose of talazoparib.|||participants|||Number
2539533|NCT03070548|Primary|Amount of Talazoparib Excreted in Urine During Each Collection Interval (Ae t1-t2)|Ae t1-t2 was defined as the amount of talazoparib excreted into urine during each collection interval (t1-t2).|Pre-dose, 0 to 8 hours (hrs), 8 to 24 hrs, 24 to 48 hrs, 48 to 72 hrs, 72 to 96 hrs and then after every 24 hrs until up to 504 hrs post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||micrograms||Standard Deviation|Mean
2539547|NCT03070548|Primary|Apparent Volume of Distribution (Vd/F) of Talazoparib|Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of the drug.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||liter||Standard Deviation|Mean
2539523|NCT03070548|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities|Haematological, biochemistry and urinalysis parameters. Biochemistry parameters:alkaline phosphatase 30-120units per liter(U/L), creatinine 53-110micromole/L(micromol/L), gamma glutamyl transferase 7-50U/L, glucose 3.3-5.5millimoles/L(mmol/L), lactate dehydrogenase 200-460U/L, triglycerides 0.4-1.7mmol/L, cholesterol 2.6-5.2mmol/L, phosphate 0.8-1.45mmol/L, sodium 135-146mmol/L, urea 2.8-7.2mmol/L, chloride 95-109mmol/L, creatine kinase 24-170U/L, aspartate aminotransferase 4-46U/L, potassium 3.5-5.5mmol/L. Haematology parameters:haemoglobin 120-155 gram/L(g/L), erythrocytes 4-5.2 10^12/L, haematocrit 0.35-0.45, prothrombin time 13.7-15.6 second(sec), lymphocytes 1-3.7 10^9/L, platelets 150-400 10^9/L, prothrombin intl. normalized ratio 0.89-1.1, activated partial thromboplastin time 25-43 sec, basophils 0-0.09 10^9/L, neutrophils 1.5-7 10^9/L, and leukocytes 4-10 10^9/L. Urinalysis parameters:urinalysis specific gravity 1.012-1.03, urinalysis pH 4.8-7.8.|Baseline up to Day 22|Safety population set included all participants who received at least 1 dose of talazoparib.|||participants|||Number
2539524|NCT03070548|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities|Criteria for clinically significant ECG abnormalities : Heart Rate; increase from baseline greater than (>)25 %and to a value >100, decrease from baseline >25% and to a value < 50; PR Interval: increase from baseline >25% and to a value >200; QRS Duration: increase from baseline >25% and to a value >100; QT interval using Fridericia's correction (QTcF): ranges >450 msec, >480 msec, >500 msec, Increase from baseline >30 msec and >60 msec; QT Interval: ranges >450 msec, >480 msec, >500 msec, Increase from baseline >30 msec and >60 msec.|Baseline up to Day 22|Safety population set included all participants who received at least 1 dose of talazoparib.|||participants|||Number
2539525|NCT03070548|Secondary|Number of Participants With Clinically Significant Vital Signs Parameters|Vital Signs included heart rate, respiratory rate, body temperature, systolic blood pressure and diastolic blood pressure. clinical significance of vital signs was determined at the investigator's discretion.|Baseline up to Day 22|Safety analysis set included all participants who received at least 1 dose of talazoparib.|||participants|||Number
2539526|NCT03070548|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug through 14 days after the last day of mass balance phase and at least 30 days after Day 1 or before initiation of new cytotoxic chemotherapy, new investigational treatment, or the first day of extension protocol, whichever occurs first (up to maximum duration of 8 weeks from screening to follow-up for each participant) or before initiation of new cytotoxic chemotherapy, new investigational treatment, or the first day of extension protocol, whichever occurs first, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both non-serious (AEs) and serious adverse events (SAEs).|Day 1 to 14 days after last day of mass balance phase and at least 30 days after Day1/before initiation of new cytotoxic chemotherapy, new investigational treatment/first day of extension protocol, whichever occurs first(up to maximum duration of 8 weeks)|Safety analysis set included all participants who received at least 1 dose of talazoparib.|||participants|||Number
2539527|NCT03070548|Secondary|Ratio of Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration to Area Under the Whole Blood Concentration-Time Curve From Time Zero to Last Quantifiable for 14C- Radioactivity|AUC(0-last) was defined as the area under the plasma concentration-time curve from zero to the time of the last measurable concentration. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||ratio||Standard Deviation|Mean
2539528|NCT03070548|Secondary|Ratio of Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity to Area Under the Whole Blood Concentration-Time Curve From Time Zero to Infinity for 14C- Radioactivity|AUC(0-inf) was defined as the area under the plasma concentration-time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||ratio||Standard Deviation|Mean
2539529|NCT03070548|Secondary|Ratio of Maximum Observed Plasma Concentration to Maximum Observed Whole Blood Concentration for 14C- Radioactivity|100 micro-curie of 14C radiolabeled talazoparib was present in 1 mg of talazoparib.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||ratio||Standard Deviation|Mean
2539530|NCT03070548|Primary|The Recovery of 14C-Radioactivity as a Percentage of the Administered Dose|Recovery of 14C-radioactivity in urine and feces was calculated in terms of percentage of administered dose after administration of a single 1 mg dose of oral solution (containing 100 micro-curie 14C-labeled talazoparib).|From 0 to 8 hrs, 8 to 24 hrs, 24 to 48 hrs and then after every 24 hrs until up to 504 hrs post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||Percentage of dose||Standard Deviation|Mean
2539531|NCT03070548|Primary|Renal Clearance (CLr) of Talazoparib|Renal clearance was calculated as cumulative amount of drug excreted in urine divided by AUC(0-last) (area under the plasma concentration-time curve from zero to the time of the last measurable concentration).|Pre-dose, 0 to 8 hrs, 8 to 24 hrs, 24 to 48 hrs, 48 to 72 hrs, 72 to 96 hrs and then after every 24 hrs until up to 504 hrs post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||liter/hour||Standard Deviation|Mean
2539532|NCT03070548|Primary|Percentage of Dose of Talazoparib Excreted During Each Collection Interval (Aet1-t2%) of Talazoparib|Aet1-t2% was the percentage of Aet1-t2, where Aet1-t2 was defined as the amount of talazoparib excreted into urine during each collection interval (t1-t2).|Pre-dose, 0 to 8 hrs, 8 to 24 hrs, 24 to 48 hrs, 48 to 72 hrs, 72 to 96 hrs and then after every 24 hrs until up to 504 hrs post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||percentage of dose||Standard Deviation|Mean
2540972|NCT03037541|Primary|Number Participants With 100% Clearance|The primary endpoint is number of participants that receive 100% clearance of AK lesions from treatment initiation to end of treatment|24 weeks||||Participants|||Count of Participants
2539534|NCT03070548|Primary|Apparent Volume of Distribution (Vd/F) of 14C- Radioactivity in Whole Blood|Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of the drug. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||liter||Standard Deviation|Mean
2539535|NCT03070548|Primary|Apparent Total Whole Blood Clearance (CL/F) of 14C- Radioactivity|Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||liter/hour||Standard Deviation|Mean
2539536|NCT03070548|Primary|Area Under the Whole Blood Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of 14C- Radioactivity|AUC(0-last) was defined as the area under the plasma concentration-time curve from zero to the time of the last measurable concentration. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||hour*nanogram equivalent/mililiter||Standard Deviation|Mean
2539537|NCT03070548|Primary|Area Under the Whole Blood Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C- Radioactivity|AUC(0-inf) was defined as the area under the plasma concentration-time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||hour*nanogram equivalent/mililiter||Standard Deviation|Mean
2539538|NCT03070548|Primary|Time to Attain Maximum Observed Whole Blood Concentration (Tmax) of 14C- Radioactivity|100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||hours||Full Range|Median
2539539|NCT03070548|Primary|Maximum Observed Whole Blood Concentration (Cmax) of 14C- Radioactivity|100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||nanogram equivalent/mililiter||Standard Deviation|Mean
2539540|NCT03070548|Primary|Apparent Volume of Distribution (Vd/F) of 14C- Radioactivity in Plasma|Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||liter||Standard Deviation|Mean
2539541|NCT03070548|Primary|Apparent Total Plasma Clearance (CL/F) of 14C- Radioactivity|Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||liter/hour||Standard Deviation|Mean
2539542|NCT03070548|Primary|Terminal Elimination Half-Life (t1/2) of 14C- Radioactivity in Plasma|Terminal elimination half-life was defined as the time measured for the plasma radioactivity concentration to decrease by one half. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||hours||Standard Deviation|Mean
2539543|NCT03070548|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of 14C- Radioactivity|AUC(0-last) was defined as the area under the plasma concentration-time curve from zero to the time of the last measurable concentration. 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||hour*nanogram equivalent/mililiter||Standard Deviation|Mean
2539544|NCT03070548|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of 14C- Radioactivity|AUC(0-inf) was defined as the area under the plasma concentration-time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). 100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||hour*nanogram equivalent/mililiter||Standard Deviation|Mean
2539545|NCT03070548|Primary|Time to Attain Maximum Observed Plasma Concentration (Tmax) of 14C- Radioactivity|100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||hours||Full Range|Median
2539546|NCT03070548|Primary|Maximum Observed Plasma Concentration (Cmax) of 14C- Radioactivity|100 micro-curie of 14C-radiolabeled talazoparib was present in 1 mg of talazoparib.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||nanogram equivalent/mililiter||Standard Deviation|Mean
2539548|NCT03070548|Primary|Apparent Total Plasma Clearance (CL/F) of Talazoparib|Clearance of a drug was measure of the rate at which a drug was metabolized or eliminated by normal biological processes.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||liter/hour||Standard Deviation|Mean
2539549|NCT03070548|Primary|Terminal Elimination Half-Life (t1/2) of Talazoparib|Terminal elimination half-life was defined as time measured for the plasma concentration of talazoparib to decrease by one half.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||hours||Standard Deviation|Mean
2539550|NCT03070548|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of Talazoparib|AUC(0-last) was defined as the area under the plasma concentration-time curve from zero to the time of the last measurable concentration.|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||hr*ng/mL||Standard Deviation|Mean
2539551|NCT03070548|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Talazoparib|AUC(0-inf) was defined as the area under the plasma concentration-time curve from time zero (pre-dose) to extrapolated infinite time (0-inf).|Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
2539552|NCT03070548|Primary|Time to Attain Maximum Observed Plasma Concentration (Tmax) of Talazoparib||Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|PK population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||hours||Full Range|Median
2539553|NCT03070548|Primary|Maximum Observed Plasma Concentration (Cmax) of Talazoparib||Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 384, 432 and 504 hours post-dose|Pharmacokinetic (PK) population included all participants who received talazoparib and had at least 1 sample with sufficient concentration data.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2539554|NCT03070470|Primary|QTc Shortening From Calcium Block (Diltiazem) in the Presence of hERG Block (Dofetilide)|"It will be assessed whether the projected QTc effect of dofetilide alone is significantly greater (i.e., p<0.05) than the projected QTc effect of the combination of dofetilide + diltiazem. This will be assessed at the dofetilide peak plasma level on Day 3 (computed from the combination of dofetilide + diltiazem) on the pooled dofetilide alone, diltiazem alone, and dofetilide + diltiazem data using a linear mixed effects model.~Subsequently, and if the test is significant for QTc, the same test will be performed to assess calcium block (diltiazem) effects on J-Tpeakc."|3 days|QTc, J-Tpeakc, and drug concentration data from all subjects in the dofetilide and diltiazem arm. Ranolazine, verapamil, lopinavir/ritonavir, chloroquine, and placebo data were collected but not part of this analysis (see SAP). The underlying raw data were the input in the statistical analysis. Summary included per PRS review team request.|||ms||Full Range|Median
2539555|NCT03070470|Primary|"Change From Baseline QTc With Predominant hERG Blocking Drug (Chloroquine)"|"The primary outcome measure for the predominant hERG drug (chloroquine) is for the upper bound of the 2-sided 90% CI to be ≥10 msec for the projected placebo-corrected change from baseline QTc effect at the peak plasma level on Day 1 using a linear mixed-effects exposure response model"|3 days|Ranolazine, verapamil, lopinavir/ritonavir, and dofetilide and diltiazem data were collected but not part of the primary QTc analysis. The underlying raw data (available at https://doi.org/10.13026/C2967M) were the input in the statistical analysis. Median and range summary included per PRS review team request.|||ms||Full Range|Median
2539556|NCT03070470|Primary|"Change From Baseline J-Tpeakc With Balanced Ion Channel Drugs (Ranolazine, Verapamil, Lopinavir / Ritonavir)"|"The primary outcome measure for the balanced ion channel drugs (ranolazine, verapamil, lopinavir / ritonavir) is for the upper bound of the 2-sided 90% confidence interval (CI) to be <10 msec for the projected placebo-corrected change from baseline J-Tpeakc effect at the peak plasma level on Day 3 using a linear mixed-effects exposure response model. Placebo drug concentration was set to 0 (see SAP)."|3 days|Placebo data was used in the statistical analysis to account for placebo effect. Chloroquine, and dofetilide and diltiazem data were collected but not part of the primary J-Tpeakc analysis. The underlying raw data (available at https://doi.org/10.13026/C2967M) were the input in the statistical analysis. Summary included per PRS review team request.|||ms||Full Range|Median
2539557|NCT03070431|Secondary|Number of Participants Who Were Able to Walk Following Radiotherapy|"Ambulatory status was assessed using the following scoring system:~0=Normal strength~Ambulatory without aid~Ambulatory with aid~Not ambulatory~A patient with a score equal to or less than 2 is considered able to walk. Both participants that could and could not walk prior to radiotherapy have been included in this assessment."|up to 6 months following radiotherapy||||Participants|||Count of Participants
2539558|NCT03070431|Secondary|Number of Participants Experiencing at Least One Grade >=2 Radiotherapy-related Toxicity|Toxicity was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) (version 4)|during radiotherapy and up to 6 months following radiotherapy||||Participants|||Count of Participants
2539559|NCT03070431|Secondary|Number of Participants Who Experienced Relief of Distress at 1 Month Following Radiotherapy Compared to Baseline|"Distress (as an indicator of impairment of quality of life) was measured with the distress-thermometer. the patients rated their level of distress on a scale ranging from 0 (no distress) to 10 (extreme distress). Patients rated the distress they experienced during the last week and stated the reasons for distress from a list of items.~An improvement (lower score) by 2 points was considered a clinically relevant relief of distress. Patients with baseline-scores of 0-1 points were not included, since improvement by 2 points was not possible."|Evaluation at 1 month following radiotherapy||||Participants|||Count of Participants
2539634|NCT03069482|Secondary|Psychotic Symptoms|Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.|3 month follow up||||score on a scale||Standard Deviation|Mean
2539560|NCT03070431|Secondary|Number of Participants Who Experienced Relief of Pain at 1 Month Following Radiotherapy Compared to Baseline|"Vertebral pain was measured with a numeric self-rating scale ranging from 0 (no pain) to 10 (worst pain).~Pain relief was defined as improvement (=decrease of pain) by at least 2 points without increase of analgesics. Patients with baseline-scores of 0-1 points were not included, since improvement by 2 points was not possible."|Evaluation at 1 month following radiotherapy||||Participants|||Count of Participants
2539561|NCT03070431|Secondary|Number of Participants Who Were Alive at 6 Months Following Radiotherapy|Overall Survival (OS) was defined as freedom from death of any cause. Time to death was calculated from the last day of radiotherapy, and the patients were followed for a maximum of 6 months after the end of radiotherapy. The values of 6-month OS were estimated using the Kaplan-Meier method.|6 months after the end of radiotherapy||||percentage of participants||95% Confidence Interval|Number
2539562|NCT03070431|Secondary|Number of Participants Who Were Alive at 3 Months Following Radiotherapy Without Deterioration of Motor Function During (or Directly Following) Radiotherapy and Freedom From In-field Recurrence of Metastatic Spinal Cord Compression Following Radiotherapy|"Local Progression Free Survival (LPFS) was defined as freedom from progression of motor deficits during or one month following radiotherapy and freedom from in-field recurrence of metastatic spinal cord compression (MSCC) following radiotherapy.~An in-field recurrence was defined as a recurrence of MSCC associated with motor deficits in the region of the spinal cord that had been previously irradiated for MSCC.~In case of clinical suspicion of sich a recurrence, a spinal MRI was performed to confirm the diagnosis. Time to in-field recurrence was calculated from the last day of radiotherapy. The values of 3-month LPFS were estimated using the Kaplan-Meier method."|3 months after the end of radiotherapy||||percentage of participants||95% Confidence Interval|Number
2539563|NCT03070431|Secondary|Number of Participants Showing Improvement of Sphincter Dysfunction Following Radiotherapy (Best Response)|Sphincter dysfunction was rates as yes (presence of sphincter dysfunction) or no (absence of sphincter dysfunction).|up to 6 months following radiotherapy|Patients who had a sphincter dysfunction prior to the start of radiotherapy.|||Participants|||Count of Participants
2539564|NCT03070431|Secondary|Number of Participants Showing Improvement of Sensory Function Following Radiotherapy (Best Response)|"Sensory function was evaluated with the following scale, modified in accordance to the classification of the American Spinal Injury Association.~0 = Absent~= Impaired~= Normal~9 = Cannot be assessed~[Baskin DS. Spinal cord injury. In Evans RW (Ed.), Neurology and trauma, WB Saunders, Philadelphia;1996, pp. 276-299.]"|up to 6 months following radiotherapy|Patients who had sensory deficits prior to the start of radiotherapy.|||Participants|||Count of Participants
2539565|NCT03070431|Secondary|Number of Participants Showing Improvement of Motor Deficits Following Radiotherapy (Best Response)|"Motor function was evaluated using the following scale. Improvement of motor function was defined as a decrease of at least 1 point.~0 = Normal strength~= Ambulatory without aid~= Ambulatory with aid~= Not ambulatory~= Complete paraplegia~[Tomita T, et al., Acta Radiol Oncol 1983;22:135-143.]"|up to 6 months following radiotherapy||||Participants|||Count of Participants
2539566|NCT03070431|Primary|Number of Participants Who Were Alive at 6 Months After Radiotherapy Without Deterioration of Motor Function During (or Directly After) Radiotherapy and Freedom From In-field Recurrence of Metastatic Spinal Cord Compression Following Radiotherapy|"Local Progression Free Survival (LPFS) was defined as freedom from progression of motor deficits during or one month following radiotherapy and freedom from in-field recurrence of metastatic spinal cord compression (MSCC) following radiotherapy.~An in-field recurrence was defined as a recurrence of MSCC associated with motor deficits in the region of the spinal cord that had been previously irradiated for MSCC.~In case of clinical suspicion of sich a recurrence, a spinal MRI was performed to confirm the diagnosis. Time to in-field recurrence was calculated from the last day of radiotherapy, and the patients were followed for a maximum of 6 months after the end of radiotherapy. The values of 6-month LPFS were estimated using the Kaplan-Meier method."|6 months after the end of radiotherapy||||percentage of participants||95% Confidence Interval|Number
2539567|NCT03070236|Primary|The Primary Outcome Measures Severity of Chronic Pain.|The Breast Cancer Pain Questionnaire (BCPQ) is a validated, self-reported instrument assessing pain severity, pain frequency (how many days per week), and pain location (breast, arm, side, axilla) over the last 2-week period with an average of 45.8 months from treatment for the two groups, Guideline Concordant Care (GCC) and Active Surveillance (AS). The Pain Burden Index (PBI) is a composite of pain severity, pain frequency, and pain location. Each severity answer is multiplied by each frequency answer and then summed with a total possible score ranging from 0-200 (our results ranged from 0-80 for GCC and 0-64 for AS) with higher scores indicating worse pain.|Patient reported outcome was scheduled from at least one year from diagnosis. Participants' time from diagnosis to completing a survey was an average of 45.8 months in this study cohort.||||Composite Score||Full Range|Mean
2539568|NCT03070171|Secondary|AUC0-∞ of Free Dabigatran|"Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).~Geometric Mean is actually Adjusted geometric mean and Geometric Coefficient of Variation (gCV) is actually Intra individual gCV."|1:00h before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|PKS|||ng•h/mL||Geometric Coefficient of Variation|Geometric Mean
2539569|NCT03070171|Secondary|AUC0-∞ of Total Dabigatran|"Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).~Geometric Mean is actually Adjusted geometric mean and Geometric Coefficient of Variation (gCV) is actually Intra individual gCV."|1:00h before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|PKS|||ng•h/mL||Geometric Coefficient of Variation|Geometric Mean
2539570|NCT03070171|Secondary|Cmax of Total Dabigatran|Maximum plasma concentration of total dabigatran (Cmax). Geometric Mean is actually Adjusted geometric mean and Geometric Coefficient of Variation (gCV) is actually Intra individual gCV.|1:00h before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2539635|NCT03069482|Secondary|Psychotic Symptoms|Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.|2 month follow up||||score on a scale||Standard Deviation|Mean
2539571|NCT03070171|Secondary|AUC0-tz of Total Dabigatran|"Area under the concentration-time curve of total dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz ).~Geometric Mean is actually Adjusted geometric mean and Geometric Coefficient of Variation (gCV) is actually Intra individual gCV."|1:00h before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|PKS|||ng•h/mL||Geometric Coefficient of Variation|Geometric Mean
2539572|NCT03070171|Primary|Cmax of Free Dabigatran|Maximum plasma concentration of free dabigatran (Cmax). Geometric Mean is actually Adjusted geometric mean and Geometric Coefficient of Variation (gCV) is actually Intra individual gCV.|1:00h before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|PKS|||Nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2539573|NCT03070171|Primary|AUC0-tz of Free Dabigatran|"Area under the concentration-time curve of free dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz). Geometric Mean (gMean) is actually Adjusted gMean & Geometric Coefficient of Variation (gCV) is actually Intra individual gCV (%gCV).~PK exclusion criteria: 1) The subject experienced emesis at or before 2 times median Time from (last) dosing to the maximum measured concentration of the analyte in plasma (tmax). Median tmax was to be taken either from the median tmax for reference product or test product, depending on whether the subject had experienced emesis after taken the test or reference product. Median tmax was to be determined excluding the subjects experiencing emesis. 2) Time deviations 3) Use of restricted medications 4) A pre-dose concentration was >5% of the Cmax value of that subject."|1:00h before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|Pharmacokinetic set (PKS): All subjects from Treated Set (TS) who provided at least 1 observation for at least 1 primary endpoint that was not excluded as per PK exclusion criteria (defined in the description).|||Nanogram*hour/milliliter (ng･h/mL)||Geometric Coefficient of Variation|Geometric Mean
2539574|NCT03070002|Secondary|Median Progression Free Survival|Assess median progression free survival (m-PFS) using statistical analysis evaluating the relationship between longitudinal CTC counts and PFS. PRS will be measured from the time of treatment up until progressive disease.|Up to 2 years|Data was not collected or analyzed for this outcome measure. The study was terminated early with only 1 patient enrolled.||||||
2539575|NCT03070002|Secondary|Percent Change in CTCs|Evaluate the effect of denosumab on CTCs enumeration by assessing the percent change from baseline.|Baseline up to 3 months|Data was not collected or analyzed for this outcome measure. The study was terminated early with only 1 patient enrolled.||||||
2539576|NCT03070002|Primary|Fraction of Patients With Reduction in CTCs|Assess the effect of denosumab in Her2/neu negative ER+ and/ or PR+ metastatic breast cancer patients who are in Partial Response (PR) or Stable Disease (SD) after starting systemic therapy with bone metastases and ≥ 5 CTCs by measuring the fraction of patients with reduction in CTCs.|Up to 3 months|Data was not collected or analyzed for this outcome measure. The study was terminated early with only 1 patient enrolled.||||||
2539577|NCT03069989|Secondary|Period 2: VT of [18F]-FBAA20FMDV2 in the Whole Lung (Not Corrected for Air Volume) Approximately 24 Hours Post-dose Compared to Pre-dose|The changes in the uptake of [18F]-FBA-A20FMDV2 in the whole lung, assessed by VT derived from kinetic analysis of the dynamic PET data was used to evaluate target engagement in the lung after single nebulized doses of GSK3008348|Baseline (pre-dose) and 24 hours post-dose PET scan 2|Per-Protocol Population. Only those participants with PET data available at the indicated time points were analyzed (represented by n= X in the category titles).|||mL/cm^3||Geometric Coefficient of Variation|Geometric Mean
2539578|NCT03069989|Secondary|Period 2: t1/2 After Single Dose Administration of GSK3008348|Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose|Pharmacokinetic Population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.||||||
2539579|NCT03069989|Secondary|Period 1: Terminal Phase Half-life (t1/2) After Single Dose Administration of GSK3008348|Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose|Pharmacokinetic Population.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2539580|NCT03069989|Secondary|Period 2: Tmax After Single Dose Administration of GSK3008348|Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose|Pharmacokinetic Population.|||Hours||Full Range|Median
2539581|NCT03069989|Secondary|Period 1: Time of Occurrence of Cmax (Tmax) After Single Dose Administration of GSK3008348|Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose|Pharmacokinetic Population.|||Hours||Full Range|Median
2539582|NCT03069989|Secondary|Period 2: Cmax After Single Dose Administration of GSK3008348|Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose|Pharmacokinetic Population.|||Picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539583|NCT03069989|Secondary|Period 1: Maximum Observed Plasma Drug Concentration (Cmax) After Single Dose Administration of GSK3008348|Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose|Pharmacokinetic Population.|||Picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539636|NCT03069482|Secondary|Psychotic Symptoms|Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.|1 month follow up||||score on a scale||Standard Deviation|Mean
2539584|NCT03069989|Secondary|Period 2: AUC(0-infinity) After Single Dose Administration of GSK3008348|Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose|Pharmacokinetic Population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).||||||
2539585|NCT03069989|Secondary|Period 1: Area Under the Plasma Concentration-time Curve From Zero Hours to Infinity (AUC[0-infinity]) After Single Dose Administration of GSK3008348|Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose|Pharmacokinetic Population. Only those participants with data available at the indicated data points were analyzed.|||Hours*picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539586|NCT03069989|Secondary|Period 2: AUC(0-t) After Single Dose Administration of GSK3008348|Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Pre-dose, and at 0.25, 0.5, 2, 4, 22 and 30 hours post-GSK3008348 dose|Pharmacokinetic Population.|||Hours*picogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539587|NCT03069989|Secondary|Period 1: Area Under the Plasma Concentration-time Curve From Zero Hours to Time (AUC[0-t]) After Single Dose Administration of GSK3008348|Blood samples were collected to evaluate the pharmacokinetics of GSK3008348 at the indicated time points. The pharmacokinetic parameters were calculated by standard non-compartmental analysis. Pharmacokinetic population consisted of all participants in the Intent-To-Treat population receiving active dose for whom a pharmacokinetic sample was analyzed.|Pre-dose, and at 0.25, 0.5, 1, 2, 4, 8, 12, 18 and 24 hours post-GSK3008348 dose|Pharmacokinetic Population.|||Hours*picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2539588|NCT03069989|Primary|Period 1: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)|FEV1 and FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 and FVC was measured using standard spirometry equipment. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1), 1 hour and 24 hours post-GSK3008348 dose|Intent-to-Treat Population.|||Liters||Standard Deviation|Mean
2539589|NCT03069989|Primary|Period 2: Number of Participants With Abnormal Findings for 12-lead ECG Parameters|Triplicate 12-lead ECG were obtained to measure ECG parameters. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.|Pre-dose (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge), Day 2 (pre-PET scan) and Day 15 (follow-up)|Intent-to-Treat Population. Only those participants with available at the indicated time points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2539590|NCT03069989|Primary|Period 1: Number of Participants With Abnormal Findings for 12-lead Electrocardiograms (ECG) Parameters|Triplicate 12-lead ECG were obtained to measure ECG parameters. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.|Pre-dose (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose|Intent-to-Treat Population.|||Participants|||Count of Participants
2539591|NCT03069989|Primary|Period 2: Change From Baseline in Vital Sign: Temperature|Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan)|Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed.|||Celcius||Standard Deviation|Mean
2539592|NCT03069989|Primary|Period 1: Change From Baseline in Vital Sign: Temperature|Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose|Intent-to-Treat Population.|||Celsius||Standard Deviation|Mean
2539593|NCT03069989|Primary|Period 2: Change From Baseline in Vital Sign: Respiration Rate|Respiration rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan)|Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed.|||Breaths per minute||Standard Deviation|Mean
2539594|NCT03069989|Primary|Period 1: Change From Baseline in Vital Sign: Respiration Rate|Respiration rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose|Intent-to-Treat Population.|||Breaths per minute||Standard Deviation|Mean
2539595|NCT03069989|Primary|Period 2: Change From Baseline in Vital Signs: Heart Rate|Heart rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan)|Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2541035|NCT03036163|Secondary|Volume of Distribution (Vd) of PBTZ169||Up to 72 hours after the last drug administration|PKA|||L||Standard Deviation|Mean
2539596|NCT03069989|Primary|Period 1: Change From Baseline in Vital Signs: Heart Rate|Heart rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose|Intent-to-Treat Population.|||Beats per minute||Standard Deviation|Mean
2539597|NCT03069989|Primary|Period 2: Change From Baseline in Vital Signs: DBP and SBP|SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1), 30 minutes (post-PET scan), Day 1 (prior to discharge) and Day 2 (pre-PET scan)|Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed.|||Millimeter of mercury||Standard Deviation|Mean
2539598|NCT03069989|Primary|Period 1: Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1), 0.5, 2, 4, 8 and 24 hours post-GSK3008348 dose|Intent-to-Treat Population.|||Millimeters of mercury||Standard Deviation|Mean
2539599|NCT03069989|Primary|Period 2: Number of Participants With Abnormal Urinalysis Results by Dipstick|Urine samples were collected at indicated time points to analyze urinalysis parameters including specific gravity, potential of hydrogen, glucose, protein, blood and ketones by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as positive, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Only categories with abnormal urinalysis values are presented.|Baseline (Day -1), 24 hours post-GSK3008348 dose and Day 15 (follow-up)|Intent-to-Treat Population. Only those participants with available at the indicated time points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2539600|NCT03069989|Primary|Period 1: Number of Participants With Abnormal Urinalysis Results by Dipstick|Urine samples were collected at indicated time points to analyze urinalysis parameters including specific gravity, potential of hydrogen, glucose, protein, blood and ketones by dipstick. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as positive, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Only categories with abnormal urinalysis values are presented.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population. Only those participants with available at the indicated time points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2539601|NCT03069989|Primary|Period 2: Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen|Blood samples were collected to analyze the chemistry parameters: calcium, glucose, potassium, sodium and blood urea nitrogen. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population. Only those participants available at the indicated time points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2539602|NCT03069989|Primary|Period 1: Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen|Blood samples were collected to analyze the chemistry parameters: calcium, glucose, potassium, sodium and blood urea nitrogen. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2539603|NCT03069989|Primary|Period 2: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine|Blood samples were collected to analyze the chemistry parameters: direct bilirubin, total bilirubin and creatinine. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population. Only those participants with available at the indicated time points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2539604|NCT03069989|Primary|Period 1: Change From Baseline in Chemistry Parameters: Direct Bilirubin, Total Bilirubin and Creatinine|Blood samples were collected to analyze the chemistry parameters: direct bilirubin, total bilirubin and creatinine. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2539605|NCT03069989|Primary|Period 2: Change From Baseline in Chemistry Parameters: Albumin and Total Protein|Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed.|||Grams per liter||Standard Deviation|Mean
2539606|NCT03069989|Primary|Period 1: Change From Baseline in Chemistry Parameters: Albumin and Total Protein|Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population.|||Grams per liter||Standard Deviation|Mean
2539607|NCT03069989|Primary|Period 2: Change From Baseline in Chemistry Parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase|Blood samples were collected to analyze the chemistry parameters: alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population. Only those participants available at the indicated time points were analyzed (represented by n= X in the category titles).|||International units per liter||Standard Deviation|Mean
2539608|NCT03069989|Primary|Period 1: Change From Baseline in Chemistry Parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase and Gamma Glutamyl Transferase|Blood samples were collected to analyze the chemistry parameters: alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatine kinase and gamma glutamyl transferase. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population. Only those participants available at the indicated time points were analyzed (represented by n= X in the category titles).|||International units per liter||Standard Deviation|Mean
2539609|NCT03069989|Primary|Period 2: Change From Baseline in Hematology Parameter: Red Blood Cell Count|Blood samples were collected to analyze the hematology parameter: red blood cell count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed.|||Trillion cells per liter||Standard Deviation|Mean
2539610|NCT03069989|Primary|Period 1: Change From Baseline in Hematology Parameter: Red Blood Cell Count|Blood samples were collected to analyze the hematology parameter: red blood cell count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population.|||Trillion cells per liter||Standard Deviation|Mean
2539611|NCT03069989|Primary|Period 2: Change From Baseline in Hematology Parameter: Mean Corpuscle Volume|Blood samples were collected to analyze the hematology parameter: mean corpuscle volume. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed.|||Femtoliters||Standard Deviation|Mean
2539612|NCT03069989|Primary|Period 1: Change From Baseline in Hematology Parameter: Mean Corpuscle Volume|Blood samples were collected to analyze the hematology parameter: mean corpuscle volume. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population.|||Femtoliters||Standard Deviation|Mean
2539613|NCT03069989|Primary|Period 2: Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin|Blood samples were collected to analyze the hematology parameter: mean corpuscle hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed.|||Picrograms||Standard Deviation|Mean
2539614|NCT03069989|Primary|Period 1: Change From Baseline in Hematology Parameter: Mean Corpuscle Hemoglobin|Blood samples were collected to analyze the hematology parameter: mean corpuscle hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population.|||Picrograms||Standard Deviation|Mean
2539615|NCT03069989|Primary|Period 2: Change From Baseline in Hematology Parameter: Hematocrit|Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2539616|NCT03069989|Primary|Period 1: Change From Baseline in Hematology Parameter: Hematocrit|Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2539617|NCT03069989|Primary|Period 2: Change From Baseline in Hematology Parameter: Hemoglobin|Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population. Only those participants with data available at the indicated time points were analyzed.|||Grams per liter||Standard Deviation|Mean
2539618|NCT03069989|Primary|Period 1: Change From Baseline in Hematology Parameter: Hemoglobin|Blood samples were collected to analyze the hematology parameter: hemoglobin. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population.|||Grams per liter||Standard Deviation|Mean
2539637|NCT03069482|Secondary|Smoking Cravings|Average daily smoking cravings as self-reported through each smartphone app. Cravings range from a score of 1 to 10 with higher scores indicating higher cravings to smoke.|Daily throughout study duration, 4 months||||units on a scale||Standard Deviation|Mean
2539619|NCT03069989|Primary|Period 2: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and WBC Count|Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, platelet count and WBC count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population.|||Giga cells per liter||Standard Deviation|Mean
2539620|NCT03069989|Primary|Period 1: Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count|Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, platelet count and WBC count. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day -1) and 24 hours post-GSK3008348 dose|Intent-to-Treat Population.|||Giga cells per liter||Standard Deviation|Mean
2539621|NCT03069989|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. Intent-to-Treat population consisted of all randomized participants who received at least one dose of study treatment.|Up to 62 days|Intent-to-Treat Population.|||Participants|||Count of Participants
2539622|NCT03069989|Primary|Period 2: Volume of Distribution (VT) of [18F]-FBA-A20FMDV2 in the Whole Lung (Not Corrected for Air Volume) at 30 Minutes Post-dose Compared to Pre-dose|The change in the uptake of [18F]-FBA-A20FMDV2 in the whole lung, assessed by VT derived from kinetic analysis of the dynamic PET data, was used to evaluate target engagement in the lung after single nebulized doses of GSK3008348. The per-Protocol population consisted of all participants in the Intent-to-Treat population who comply with the protocol and that had at least one evaluable PET measurement post-dose.|Baseline (pre-dose) and 30 minutes post-dose|Per-Protocol Population. Only those participants with data available at the indicated time points were analyzed.|||Milliliter per cubic centimeter(mL/cm^3)||Geometric Coefficient of Variation|Geometric Mean
2539623|NCT03069677|Secondary|Block Times|differences amongst music and midaz group|immediately after nerve block placement (less than 1 minute after)|there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group|||minutes||Standard Deviation|Mean
2539624|NCT03069677|Secondary|Evaluation of Difficulties in Communication From Provider to Patient and Patient to Provider|"surveyed on a 5-point Likert scale~Scale ranges from 1 to 5; the higher the number, the more difficult it is to communicate."|immediately after nerve block placement (less than 1 minute after)|there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group|||score on a scale||Inter-Quartile Range|Median
2539625|NCT03069677|Secondary|Provider Satisfaction Scores of the Experience During Procedure|"survey which assess satisfaction on a 10-point numeric rating scale~Scale ranges from 0 to 10. A higher number indicates a higher satisfaction"|immediately after nerve block placement (less than 1 minute after)|there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group|||units on a scale||Inter-Quartile Range|Median
2539626|NCT03069677|Secondary|Patient Satisfaction Scores of the Experience During Procedure|"survey which assess satisfaction on a 10-point numeric rating scale~Scale ranges from 0 to 10. A higher number indicates a higher satisfaction"|immediately after nerve block placement (less than 1 minute after)|there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group|||units on a scale||Inter-Quartile Range|Median
2539627|NCT03069677|Primary|Change in STAI-6 Scores From Post to Pre.|"Spielberger State-Trait Anxiety Inventory 6~Scale range is from 20 to 80. Higher the score, the higher the anxiety level is."|1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)|there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group|||score on a scale||Standard Deviation|Mean
2539628|NCT03069677|Primary|Anxiety Levels|"Spielberger State-Trait Anxiety Inventory 6~Scale range is from 20 to 80. Higher the score, the higher the anxiety level is."|1-2 minutes before conducting golden moment for nerve block placement and immediately after nerve block placement (less than 1 minute after)|there was incomplete collection of data and patients dropped out which resulted in 77 total analyzed participants in this group|||score on a scale||Inter-Quartile Range|Median
2539629|NCT03069482|Secondary|General Psychiatric Symptoms|General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.|4 month follow up||||score on a scale||Standard Deviation|Mean
2539630|NCT03069482|Secondary|General Psychiatric Symptoms|General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.|3 month follow up||||score on a scale||Standard Deviation|Mean
2539631|NCT03069482|Secondary|General Psychiatric Symptoms|General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.|2 month follow up||||score on a scale||Standard Deviation|Mean
2539632|NCT03069482|Secondary|General Psychiatric Symptoms|General psychiatric symptoms at the specified time point as measured by the Global Severity Index of the Brief Symptom Inventory. Scores range from 0 to 4 with higher scores indicating more psychiatric symptoms.|1 month follow up||||score on a scale||Standard Deviation|Mean
2539633|NCT03069482|Secondary|Psychotic Symptoms|Psychotic symptoms (positive and negative symptoms) at the specified time point as measured by the Positive and Negative Symptoms Scale. Scores range from 7 to 49 with higher scores indicating more psychopathology.|4 month follow up||||score on a scale||Standard Deviation|Mean
2539638|NCT03069482|Secondary|Affect Ratings - QuitGuide|Percent of reported positive, negative, and mixed affect. Negative affect was coded as '1' when the following types of mood were reported using the mood tracking feature within the app: frustrated, stressed, nervous, anxious, angry, sad. Positive affect was coded as '1' when the following types of mood were reported using the mood tracking feature within the app: happy, relaxed, excited. Mixed affect was coded as '1' when there were instances where participants reported both positive and negative affect at different times of the day.|Daily throughout study, 4 months|Participants in the QuitGuide group.|||Percent of counts|||Number
2539639|NCT03069482|Secondary|Affect Ratings - Learn to Quit|Average mood rating as self-reported through the Learn to Quit app. Ratings range from 1-10 with lower scores indicating poorer mood ratings.|Daily throughout study duration, 4 months|Participants in the Learn to Quit group.|||score on a scale||Standard Deviation|Mean
2539640|NCT03069482|Secondary|Nicotine Replacement Lozenge Utilization|Days of lozenge use over the last 30 days.|4 month follow up||||days of lozenge use||Standard Deviation|Mean
2539641|NCT03069482|Secondary|Nicotine Replacement Lozenge Utilization|Days of lozenge use over the last 30 days.|3 month follow up||||days of lozenge use||Standard Deviation|Mean
2539642|NCT03069482|Secondary|Nicotine Replacement Lozenge Utilization|Days of lozenge use over the last 30 days.|2 month follow up||||days of lozenge use||Standard Deviation|Mean
2539643|NCT03069482|Secondary|Nicotine Replacement Lozenge Utilization|Days of lozenge use over the last 30 days.|1 month follow up||||days of lozenge use||Standard Deviation|Mean
2539644|NCT03069482|Secondary|Nicotine Replacement Patch Utilization|Days of patch use over the last 30 days.|4 month follow up||||days of patch use||Standard Deviation|Mean
2539645|NCT03069482|Secondary|Nicotine Replacement Patch Utilization|Days of patch use over the last 30 days.|3 month follow up||||days of patch use||Standard Deviation|Mean
2539646|NCT03069482|Secondary|Nicotine Replacement Patch Utilization|Days of patch use over the last 30 days.|2 month follow up||||days of patch use||Standard Deviation|Mean
2539647|NCT03069482|Secondary|Nicotine Replacement Patch Utilization|Days of patch use over the last 30 days.|1 month follow up||||days of patch use||Standard Deviation|Mean
2539648|NCT03069482|Secondary|Change in Average Number of Cigarettes Smoked Per Day|Change in average number of self-reported cigarettes smoked per day per arm from baseline to the specified time point.|Baseline to 1, 2, 3 and 4 month follow up||||cigarettes per day||Standard Deviation|Mean
2539649|NCT03069482|Secondary|Change in Nicotine Dependence as Measured by the Fagerstrom Test of Nicotine Dependence|"The Fagerstrom Test of Nicotine Dependence ranges from 0 to 10 with the lower score indicating no dependence and the highest score indicating very dependent"|Baseline to 1, 2, 3 and 4 month follow up||||units on a scale||Standard Deviation|Mean
2539650|NCT03069482|Secondary|Average Number of Quit Attempts Per Arm|Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.|4 month follow up||||quit attempts||Standard Deviation|Mean
2539651|NCT03069482|Secondary|Average Number of Quit Attempts Per Arm|Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.|3 month follow up||||quit attempts||Standard Deviation|Mean
2539652|NCT03069482|Secondary|Average Number of Quit Attempts Per Arm|Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.|2 month follow up||||quit attempts||Standard Deviation|Mean
2539653|NCT03069482|Secondary|Average Number of Quit Attempts Per Arm|Average number of quit attempts per group defined as self-reported no smoking at all for 24 hours at the specified time point.|1 month follow up||||quit attempts||Standard Deviation|Mean
2539654|NCT03069482|Secondary|24-hour Point Prevalence Abstinence|Participants who self-reported not smoking for 24 hours prior to the specified timepoint.|4 month follow up||||Participants|||Count of Participants
2539655|NCT03069482|Secondary|24-hour Point Prevalence Abstinence|Participants who self-reported not smoking for 24 hours prior to the specified timepoint.|3 month follow up||||Participants|||Count of Participants
2539656|NCT03069482|Secondary|24-hour Point Prevalence Abstinence|Participants who self-reported not smoking for 24 hours prior to the specified timepoint.|2 month follow up||||Participants|||Count of Participants
2539657|NCT03069482|Secondary|24-hour Point Prevalence Abstinence|Participants who self-reported not smoking for 24 hours prior to the specified timepoint.|1 month follow up||||Participants|||Count of Participants
2539658|NCT03069482|Secondary|7-day Point Prevalence Abstinence|Participants who self-reported not smoking for 7 days prior to the specified timepoint.|4 month follow up||||Participants|||Count of Participants
2539659|NCT03069482|Secondary|7-day Point Prevalence Abstinence|Participants who self-reported not smoking for 7 days prior to the specified timepoint.|3 month follow up||||Participants|||Count of Participants
2539660|NCT03069482|Secondary|7-day Point Prevalence Abstinence|Participants who self-reported not smoking for 7 days prior to the specified timepoint.|2 month follow up||||Participants|||Count of Participants
2539661|NCT03069482|Secondary|7-day Point Prevalence Abstinence|Participants who self-reported not smoking for 7 days prior to the specified timepoint.|1 month follow up||||Participants|||Count of Participants
2539662|NCT03069482|Secondary|30-day Point Prevalence Abstinence Rates|Participants who self-reported not smoking for 30 days prior to the specified timepoint.|4 month follow up||||Participants|||Count of Participants
2539663|NCT03069482|Secondary|30-day Prevalence Abstinence Rates|Participants who self-reported not smoking for 30 days prior to the specified timepoint.|3 month follow up||||Participants|||Count of Participants
2539664|NCT03069482|Secondary|30-day Point Prevalence Abstinence Rates|Participants who self-reported not smoking for 30 days prior to the specified timepoint.|2 month follow up||||Participants|||Count of Participants
2539665|NCT03069482|Secondary|30-day Point Prevalence Abstinence Rates|Participants who self-reported not smoking for 30 days prior to the specified timepoint.|1 month follow up||||Participants|||Count of Participants
2539744|NCT03066102|Secondary|Change From Baseline in Shoulder Kinematics Data During Shoulder Elevation in the Scapular Plane|use Liberty to detect the motion of spine, humerus, and scapula during shoulder elevation in the scapular plane (scaption)|through fatigue intervention completion, an average of 20 minutes in female subjects and 40 minutes in male subjects||||degree||Standard Deviation|Mean
2539666|NCT03069482|Secondary|Biochemically Confirmed Prolonged Abstinence Rates|Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.|4 month follow up|A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants.|||Participants|||Count of Participants
2539667|NCT03069482|Secondary|Biochemically Confirmed Prolonged Abstinence Rates|Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.|3 month follow up|A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants.|||Participants|||Count of Participants
2539668|NCT03069482|Secondary|Biochemically Confirmed Prolonged Abstinence Rates|Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent|2 month follow up|A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants.|||Participants|||Count of Participants
2539669|NCT03069482|Secondary|Biochemically Confirmed Prolonged Abstinence Rates|Total number of participants in each group reporting prolonged abstinence at the specified time point. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period, AND by a result of ≤ 6 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent|1 month follow up|A survey branching logic error led to incomplete data collection for this measure. Therefore, we could not collect data from all participants.|||Participants|||Count of Participants
2539670|NCT03069482|Secondary|Biochemically Confirmed 7-day Point Prevalence Abstinence|Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.|4 month follow-up||||Participants|||Count of Participants
2539671|NCT03069482|Secondary|Biochemically Confirmed 7-day Point Prevalence Abstinence|Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.|3 month follow-up||||Participants|||Count of Participants
2539672|NCT03069482|Secondary|Biochemically Confirmed 7-day Point Prevalence Abstinence|Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.|2 month follow-up||||Participants|||Count of Participants
2539673|NCT03069482|Secondary|Biochemically Confirmed 7-day Point Prevalence Abstinence|Percent of subjects in each group reporting biochemically confirmed 7-day point prevalence abstinence. Abstinence is determined by a self-report of not smoking for 7 days prior to the specified timepoint AND by a result of ≤ 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.|1 month follow-up||||Participants|||Count of Participants
2539674|NCT03069482|Primary|Usability of App Design as Measured by the System Usability Scale (SUS)|10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.|4-month follow-up||||score on a scale||Standard Deviation|Mean
2539675|NCT03069482|Primary|Usability of App Design as Measured by the System Usability Scale (SUS)|10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.|3-month follow-up||||score on a scale||Standard Deviation|Mean
2539676|NCT03069482|Primary|Usability of App Design as Measured by the System Usability Scale (SUS)|10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.|2-month follow-up||||score on a scale||Standard Deviation|Mean
2539677|NCT03069482|Primary|Usability of App Design as Measured by the System Usability Scale (SUS)|10-item scale giving a global assessment of systems usability using a 5-point Likert Scale with a composite score ranging from 0-100. Higher scores indicate higher usability rating.|1-month follow-up||||score on a scale||Standard Deviation|Mean
2539678|NCT03069482|Primary|Feasibility of Measurement Strategy|Percent completion of assessment measures. Assessment measures include surveys, questionnaires, and cognitive tasks.|Approximately 19 months|Number of total possible assessment measures that could have been completed in each group.|||assessments|assessments||Count of Units
2539679|NCT03069482|Primary|Recruitment Yield Effort|Percent of subjects responding to ads and clinician referrals|Approximately 15 months||||Participants|||Count of Participants
2539680|NCT03069482|Primary|Feasibility as Measured by Study Attrition|Number and percentage of subjects who complete 4-month follow up assessment|4-months||||Participants|||Count of Participants
2539716|NCT03068312|Primary|Change in Lung Clearance Index 2.5 (LCI2.5)|LCI2.5 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting value.|From baseline through 8 weeks|The Full Analysis Set (FAS) included all randomized subjects who carried the intended CFTR allele mutation and received at least 1 dose of study drug.|||lung clearance index||Standard Error|Least Squares Mean
2539681|NCT03069482|Primary|Feasibility as Measured by Study Accrual Relative to Recruitment Goal|Percent of subjects consented into study relative to study recruitment goal (N=90).92 subjects signed consent prior to eligibility determination and randomization.|Approximately 15 months|The number of participants analyzed in this sample is larger than the number of participants who were ultimately randomized to the study as reflected in the participant flow section. This sample includes all participants who were consented into the study regardless of their final eligibility status prior to randomization.|||percentage of target accrual|||Number
2539682|NCT03069482|Primary|Duration of App Use|Mean duration of app use in each group over the course of study participation (4 months)|Daily throughout study duration, 4 months||||hours||Standard Deviation|Mean
2539683|NCT03069482|Primary|Days of App Use|Frequency of app openings in each group|Daily throughout study duration, 4 months||||days||Standard Deviation|Mean
2539684|NCT03069365|Secondary|Percentage of Participants With Post-treatment Relapse|"Post-treatment relapse was defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) ≥ the lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < LLOQ at the end of treatment and had post-treatment HCV RNA data; participants who had been shown to be reinfected were not considered to have relapsed.~."|Up to 12 weeks after the last dose of study drug|Intent to treat population: all participants who received at least 1 dose of study drug and who completed treatment, had HCV RNA < LLOQ at final treatment visit, and had at least one post-treatment HCV RNA value|||percentage of participants||95% Confidence Interval|Number
2539685|NCT03069365|Secondary|Percentage of Participants With On-treatment Virologic Failure|"On-treatment virologic failure was defined as:~Confirmed increase from nadir in hepatitis C virus ribonucleic acid (HCV RNA) defined as confirmed increase of > 1 log (subscript)10(subscript) IU/mL above nadir during treatment; or~Confirmed HCV RNA greater than or equal to 100 IU/mL after HCV RNA less than the lower limit of quantification (LLOQ) during study drug treatment; or~HCV RNA ≥ LLOQ at the end of treatment with at least 6 weeks of treatment"|Up to 16 weeks|Intent to treat population: all participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2539686|NCT03069365|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post Dosing (SVR12)|SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.|12 weeks after the last actual dose of study drug|Intent to treat population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were counted as non-responders|||percentage of participants||95% Confidence Interval|Number
2539687|NCT03069352|Post-Hoc|Overall Survival After an Additional 6-Months Follow-up|Overall survival is defined as the time from the date of randomization to the date of death. Participants who had not died were censored at the date they were last known to be alive on or before the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology.|From randomization until the 6-month follow-up analysis cut-off date of August 15, 2019; the median follow-up time was 17.7 months (range: 0.2-20.8) in the placebo arm and 17.5 months (range: 0.1-23.5) in the venetoclax arm.|Full analysis set|||months||95% Confidence Interval|Median
2539688|NCT03069352|Secondary|Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh) by Mutation Subgroup|"The percentage of participants who achieved a complete remission or complete remission with partial hematologic recovery assessed by the investigator for participants with the following mutations:~Isocitrate dehydrogenase 1 and 2 (IDH1/2) mutation~FMS-like tyrosine kinase 3 (FLT3) mutation~CR is defined according to the modified IWG criteria for AML as no morphologic evidence of AML, ANC ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.~CRh is achieved when the following criteria are met:~Bone marrow with < 5% blasts and~Peripheral blood neutrophil count > 0.5 × 10³/μL and~Peripheral blood platelet count > 0.5 × 10⁵/μL and~A 1 week platelet transfusion-free period prior to hematology lab collection. Participants with no disease assessments were considered non-responders"|Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.|Full analysis set participants in each mutation subgroup|||percentage of participants|||Number
2539689|NCT03069352|Secondary|Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) by Mutation Subgroup|"Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the IWG for AML:~CR: No morphologic evidence of AML and ANC ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.~CRi: All criteria as CR except for residual neutropenia < 10³/μL or thrombocytopenia < 10⁵/μL. If all criteria for CR are met except RBC transfusion independence, CRi criteria is met.~Participants who had no IWG disease assessments were considered to be non-responders.~Response was analyzed in participants with the following mutations:~Isocitrate dehydrogenase 1 and 2 (IDH1/2) mutation~FMS-like tyrosine kinase 3 (FLT3) mutation"|Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.|Full analysis set participants in each mutation subgroup|||percentage of participants|||Number
2539690|NCT03069352|Secondary|Overall Survival (OS) by Mutation Subgroups|"Overall survival is defined as the time from the date of randomization to the date of death. Participants who had not died were censored at the date they were last known to be alive on or before the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology.~Overall survival was analyzed in participants with the following molecular markers:~Isocitrate dehydrogenase 1 and 2 (IDH1/2) mutation~FMS (Feline McDonough Sarcoma)-like tyrosine kinase 3 (FLT3) mutation"|From randomization until the primary analysis cut-off date of February 15, 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.|The full analysis set; participants in each mutation subgroup|||months||95% Confidence Interval|Median
2550317|NCT02838017|Primary|Number of Participants With Wound Complication|Wound drainage, Cellulitis, Abscess, Hematoma, Seroma or Separation|6-8 weeks from cesarean delivery||||Participants|||Count of Participants
2539691|NCT03069352|Secondary|Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh) and Minimal Residual Disease (MRD) Response|"The percentage of participants with complete remission or complete remission with partial hematologic recovery (CRh) AND MRD response as assessed by the investigator.~CR is defined according to the modified IWG response criteria for AML as no morphologic evidence of AML, ANC ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.~CRh is achieved when the following criteria are met:~Bone marrow with < 5% blasts and~Peripheral blood neutrophil count of > 0.5 × 10³/μL and~Peripheral blood platelet count of > 0.5 × 10⁵/μL and~A 1 week platelet transfusion-free period prior to the hematology lab collection.~MRD response (at lowest-point MRD value) was defined as less than 10⁻³ residual blasts per leukocyte measured in the bone marrow, per ELN recommendations.~Participants who had no disease or MRD assessments were considered to be non-responders."|Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2539692|NCT03069352|Secondary|Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) and Minimal Residual Disease (MRD) Response|"The percentage of participants with complete remission or complete remission with incomplete blood count recovery AND minimal residual disease (MRD) as assessed by the investigator. Response was based on the modified IWG response criteria for AML:~CR: No morphologic evidence of AML and ANC ≥ 10³/μL, platelets ≥ 10⁵/μL, red blood cell (RBC) transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.~CRi: All criteria as CR except for residual neutropenia < 10³/μL or thrombocytopenia < 10⁵/μL. If all criteria for CR are met except RBC transfusion independence, CRi criteria are met.~MRD response (at lowest-point MRD value) was defined as having less than 10⁻³ residual blasts per leukocyte measured in the bone marrow, per European LeukemiaNet (ELN) recommendations.~Participants who had no disease or MRD assessments were considered to be non-responders."|Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2539693|NCT03069352|Secondary|Percentage of Participants With Platelet Transfusion Independence Among Those Who Were Transfusion Dependent at Baseline|The rate of conversion was calculated as the percentage of participants who were post-baseline platelet transfusion independent among participants who had a platelet transfusion within 8 weeks prior to the first dose of study drug (i.e. were transfusion dependent at Baseline). Platelet transfusion independence is defined as a period of at least 56 days with no platelet transfusion after the first dose of study drug and on or before the last dose of study drug plus 30 days, or disease progression, or confirmed morphological relapse, or death, or the data cut-off date, whichever occurred earlier.|From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.|Full analysis participants who were platelet transfusion dependent at Baseline|||percentage of participants||95% Confidence Interval|Number
2539694|NCT03069352|Secondary|Percentage of Participants With RBC Transfusion Independence Among Those Who Were Transfusion Dependent at Baseline|The rate of conversion was calculated as the percentage of participants who were post-baseline RBC transfusion independent among participants who had an RBC transfusion within 8 weeks prior to the first dose of study drug (i.e. were transfusion dependent at Baseline). RBC transfusion independence is defined as a period of at least 56 days with no RBC transfusion after the first dose of study drug and on or before the last dose of study drug plus 30 days, or disease progression, or confirmed morphological relapse, or death, or the data cut-off date, whichever occurred earlier.|From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.|Full analysis set participants who were RBC transfusion-dependent at Baseline|||percentage of participants||95% Confidence Interval|Number
2539695|NCT03069352|Secondary|Percentage of Participants With Post Baseline Platelet Transfusion Independence|The post baseline platelet transfusion independence rate was calculated as the percentage of participants who achieved platelet transfusion independence post Baseline. Platelet transfusion independence is defined as a period of at least 56 consecutive days with no platelet transfusion after the first dose of study drug and on or before the last dose of study drug plus 30 days, or disease progression, or confirmed morphological relapse, or death, or the data cut--off date, whichever occurred earlier.|From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2539696|NCT03069352|Secondary|Percentage of Participants With Post Baseline Red Blood Cell (RBC) Transfusion Independence|The post baseline red blood cell (RBC) transfusion independence rate was calculated as the percentage of participants who achieved RBC transfusion independence post baseline. RBC transfusion independence is defined as a period of at least 56 consecutive days with no RBC transfusion after the first dose of study drug and on or before the last dose of study drug plus 30 days, or disease progression, or confirmed morphological relapse, or death, or the data cut-off date, whichever occurred earlier.|From first dose of study drug until 30 days after last dose up to the data cut-off date of 15 February 2019; Median time on treatment was 1.7 months (range: 0.1-14.2) in the placebo arm and 3.9 months (range: 0.0-17.1) in the venetoclax arm.|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2539717|NCT03067948|Primary|Audio Recording Data - Mental Health/Substance Use Action Taken|Number of participants for whom review of transcript of clinic visit characterized discussion of mental health issues and referral for services|Visit following intervention which will occur on the same day or up to 1 week after the intervention||||Participants|||Count of Participants
2540840|NCT03040011|Secondary|POD 3 Narcotic Consumption|The total amount of narcotic pain medication used on postoperative day 3 was calculated and measured in oral morphine equivalents.|Postoperative day 3||||oral morphine equivalents||Inter-Quartile Range|Median
2539697|NCT03069352|Secondary|Event-free Survival (EFS)|"Event-free survival is defined as the time from randomization to the date of progressive disease (PD), confirmed morphologic relapse from CR or CRi, treatment failure (failure to achieve CR, CRi or morphologic leukemia free state (MLFS) after at least 6 cycles of study treatment), or death from any cause, assessed by the investigator according to the modified IWG criteria.~PD:~> 50% increase in marrow blasts (minimum 15% increase required if blasts < 30% at baseline); or persistent marrow blast > 70% for ≥ 3 months; without at least a 100% improvement in ANC to an absolute level > 0.5 × 10⁹/L, and/or platelets to > 50 × 10⁹/L non-transfused; or~50% increase in peripheral blasts to > 25 × 10⁹/L; or~New extramedullary disease~Participants with no events prior to the cut-off date were censored at their last assessment date; participants with no events prior to post-treatment therapy initiated before the cut-off date were censored on the start date of post-treatment therapy."|From randomization until the primary analysis cut-off date of February 15, 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.|Full analysis set|||months||95% Confidence Interval|Median
2539698|NCT03069352|Secondary|Change From Baseline in Global Health Status / Quality of Life|"The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) consists of a Global Health Status/Quality of Life (GHS/QoL) scale, a Financial Difficulties scale, 5 functional scales (Cognitive, Social, Physical, Emotional, and Role Functioning), and 8 symptom scales/items (Fatigue, Insomnia, Appetite Loss, Pain, Constipation, Diarrhea, Dyspnea, and Nausea and Vomiting).~The GHS/QoL scale includes 2 questions in which participants were asked to rate their overall health and overall quality of life during the past week on a scale from 1 (very poor) to 7 (excellent). The 2 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life."|Baseline and Day 1 of Cycles 3, 5, 7, and 9|Full analysis set with available data at Baseline and each time point|||scores on a scale||Standard Error|Least Squares Mean
2539699|NCT03069352|Secondary|Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a|PROMIS Fatigue SF 7a is a seven-item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 7a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from Baseline) indicates improvement in fatigue; the minimum important difference used in this study was 3 points.|Baseline and Day 1 of Cycles 3, 5, 7, and 9|Full analysis set with available data at baseline and each time point|||score on a scale||Standard Error|Least Squares Mean
2539700|NCT03069352|Secondary|Percentage of Participants With Complete Remission|"The complete remission rate is defined as the percentage of participants with complete remission (CR) at any time during the study as assessed by the investigator. Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the International Working Group (IWG) for AML. CR is defined as no morphologic evidence of AML and absolute neutrophil count ≥ 10³/μL, platelets ≥ 10⁵/μL, red blood cell transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.~Participants who had no IWG disease assessments were considered to be non-responders."|Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2539701|NCT03069352|Secondary|Percentage of Participants With Complete Remission and Complete Remission With Partial Hematologic Recovery (CR + CRh) by Initiation of Cycle 2|"The percentage of participants who achieved a complete remission (CR) or complete remission with partial hematologic recovery (CRh) before initiation of Cycle 2 assessed by the investigator.~CR is defined according to the revised guidelines by the IWG for AML as no morphologic evidence of AML, ANC count ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.~CRh is a derived response based on bone marrow blast and hematology lab values, achieved when when the following criteria are met:~Bone marrow with < 5% blasts and~Peripheral blood neutrophil count of > 0.5 × 10³/μL and~Peripheral blood platelet count of > 0.5 × 10⁵/μL and~A 1-week platelet transfusion-free period prior to the hematology lab collection.~Participants with no disease assessments were considered to be non-responders."|Cycle 1, 28 days|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2539702|NCT03069352|Secondary|Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi) by Initiation of Cycle 2|"The composite complete remission rate is defined as the percentage of participants with complete remission (CR) or complete remission with incomplete blood count recovery (CRi) before initiation of Cycle 2, assessed by the investigator. Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the IWG for AML:~CR: No morphologic evidence of AML and absolute neutrophil count ≥ 10³/μL, platelets ≥ 10⁵/μL, red cell transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.~CRi: All criteria as CR except for residual neutropenia < 10³/μL or thrombocytopenia < 10⁵/μL. If all criteria for CR are met except for RBC transfusion independence, CRi criteria are met.~Participants who had no IWG disease assessments were considered to be non-responders."|Cycle 1, 28 days|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2539718|NCT03067948|Primary|Mental Health or Substance Use Issue Raised in Visit|Number of participants for whom review and coding of audio recording captured a mental health or substance use issue during their visit|Visit following intervention which will occur on the same day or up to 1 week after the intervention||||Participants|||Count of Participants
2539745|NCT03066102|Secondary|Change From Baseline in Scapular Muscle Strength|use dynamometer to detect the force of maximum isometric voluntary contraction of upper trapezius, lower trapezius and serratus anterior|through fatigue intervention completion, an average of 20 minutes in female subjects and 40 minutes in male subjects||||kilograms||Standard Deviation|Mean
2539703|NCT03069352|Secondary|Percentage of Participants With Complete Remission or Complete Remission With Partial Hematologic Recovery (CR + CRh)|"The percentage of participants who achieved a complete remission (CR) or complete remission with partial hematologic recovery (CRh) at any time point during the study assessed by the investigator.~CR is defined according to the revised guidelines by the IWG for AML as no morphologic evidence of AML, ANC count ≥ 10³/μL, platelets ≥ 10⁵/μL, RBC transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.~CRh is a derived response based on bone marrow blast and hematology lab values, achieved when the following criteria are met:~Bone marrow with < 5% blasts and~Peripheral blood neutrophil count of > 0.5 × 10³/μL and~Peripheral blood platelet count of > 0.5 × 10⁵/μL and~A 1 week platelet transfusion-free period prior to the hematology lab collection.~Participants with no disease assessments were considered to be non-responders."|Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2539704|NCT03069352|Secondary|Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi)|"The composite complete remission rate is defined as the percentage of participants with complete remission (CR) or complete remission with incomplete blood count recovery (CRi) at any time during the study as assessed by the investigator. Response was based on physical examination, bone marrow results and hematology values according to the revised guidelines by the International Working Group (IWG) for AML:~CR: No morphologic evidence of AML and absolute neutrophil count (ANC) ≥ 10³/μL (1,000/μL), platelets ≥ 10⁵/μL (100,000/μL), red blood cell (RBC) transfusion independence, and bone marrow with < 5% blasts, absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.~CRi: All criteria as CR except for residual neutropenia < 10³/μL or thrombocytopenia < 10⁵/μL. If all criteria for CR are met except RBC transfusion independence, the CRi criteria are met.~Participants who had no IWG disease assessments were considered to be non-responders."|Response was assessed at the end of Cycle 1 and every 3 cycles thereafter to the end of treatment. Median treatment duration at the 15 February 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2539705|NCT03069352|Primary|Overall Survival (OS)|Overall survival is defined as the time from the date of randomization to the date of death. Participants who had not died were censored at the date they were last known to be alive on or before the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology.|From randomization until the primary analysis cut-off date of February 15 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.|The full analysis set included all randomized participants.|||months||95% Confidence Interval|Median
2539706|NCT03069313|Secondary|Percentage Change of Serum Levels of Vitamin B12, C-reactive Protein (CRP), Homoscyteine (HCys) and Methylmalonic Acid (MMA).|Inflammatory markers were measured pre and post treatment.|Baseline and at 90 days (+/- 10 days)|postmenopasual women receiving AI|||Percentage change||Standard Deviation|Median
2539707|NCT03069313|Secondary|Percentage Change in Functional Quality of Life as Measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES)|All of the items in this questionnaire have a 5 scale rating, from not at all (0) to very much (4). Outcomes were measured pre and post treatment. Version 4 of the FACT-ES contains 3 subscales with seven questions: Physical Well-Being (PWB) (score range 0-28), Functional Well-Being (FWB) (score range 0-28), and Social and Well-Being (SWB) (score range 0-28); Emotional Well-Being (EWB) (score range 0-24) with six questions, and the Endocrine Symptom Subscale (ESS) (score range 0-76) containing 19 questions. For all subscale a higher score represents better quality of life.|Baseline and 90 days (+/- 10 days)|postemneopausal women with ER + , Stages I-III breast cancer|||Percentage change||Standard Deviation|Mean
2539708|NCT03069313|Secondary|Percentage Change in Worst Pain at the End of Treatment .|"Analysis of the data collected at baseline and at the end of treatment in the BPI-SF questionnaire. The Brief Pain Inventory - Short Form (BPI- SF) worst pain score used. This item has a scale of 0 to 10 with 0 indicating No pain and 10 indicating Pain as bad as you can imagine. Participants were asked to rate worst pain an average pain within the last 24 hours."|Baseline and 90 days (+/- 10 days)|Postmenopausal women with ER+ breast cancer, stages I-III on aromatase inhibitors and musculoskeletal pain (average pain level > or=4 using BPI-SF)|||Percentage change||Standard Deviation|Mean
2539709|NCT03069313|Primary|Percentage Change in Average Joint Pain in Women With Aromatase Inhibitor-associated Musculoskeletal Symptoms (AIMSS) Compared to Baseline as Measured by the Brief Pain Inventory Short Form (BPI-SF).|"The Brief Pain Inventory - Short Form (BPI- SF) average pain score used. This item has a scale of 0 to 10 with 0 indicating No pain and 10 indicating Pain as bad as you can imagine We expect at least 20% improvement in BPI-SF pain scores. Participants were asked to rate worst pain an average pain within the last 24 hours."|Baseline and 90 days (+/- 10 days)|A total of forty-one patients were enrolled, five patients withdrew, leaving thirty-six patients to complete the study.|||Percentage change||Standard Deviation|Mean
2539710|NCT03068767|Primary|The Change of Serum qHBsAg (IU/mL)|The serum qHBsAg levels were measured before and after 2-month vitamin D supplement|baseline, after 2-month vitamin D supplement|Levels of qHBsAg before and after 2 months of vitamin D treatment or follow-up were compared between these two groups.|||IU/mL||Standard Deviation|Mean
2539711|NCT03068767|Primary|The Dynamic Change of HBV DNA|the serum HBV DNA levels were measured in CH-B patients before and after 2-month vitamin D supplement|baseline, after 2-month vitamin D supplement||||IU/mL||Standard Deviation|Mean
2539712|NCT03068611|Primary|Number of Heavy Drinking Days at 6 Months|Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men|6 months after enrollment||||Days||Standard Deviation|Mean
2539713|NCT03068611|Primary|Number of Heavy Drinking Days at 1 Month|Self reported number of days (in the past 30 days) drinking 4+/5+ drinks for women/men|1 month after enrollment||||Days||Standard Deviation|Mean
2539714|NCT03068611|Primary|Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 6 Months|Self-report abstinence from smoking|6 months after enrollment||||Participants|||Count of Participants
2539715|NCT03068611|Primary|Number of Participants Who Reported 7-day Point-prevalence Smoking Abstinence at 1 Month|Self-report abstinence from smoking|1 month after enrollment||||Participants|||Count of Participants
2539719|NCT03067506|Primary|Correlation Coefficient Between Measures of Cognition (N-back Scores) and Performance on the CANTAB Test: Rapid Visual Information Processing (RVP)|"The n-back was used to assess cognition 3 times a day. Participants responded by touching the watch face when a symbol matched the one presented 2-back. Average daily n-back score (d-prime) was calculated.~CANTAB tests consists of a battery of neuropsychological tests. RVP measures sustained attention. A white box appears in the center of the computer screen, inside which digits, from 2 to 9, appear in a pseudo-random order, at the rate of 100 digits per minute. Participants are requested to detect target sequences of digits.~RVPA=measure of sensitivity to the target, regardless of response tendency (expected range is 0.00 to 1.00).~Speed of Processing (RVPMDL)=The mean response latency during assessment sequence blocks where the participant responded correctly.~Pearson's correlation coefficient measured linear correlation between n-back scores from Apple Watch and CANTAB tests, provided a value +1=positive correlation to -1=negative correlation. 0=no correlation."|Baseline up to Week 6|Analysis population included all participants with major depressive disorder (MDD) who were enrolled in the study.|||Correlation Coefficient (r)||95% Confidence Interval|Number
2539720|NCT03067506|Primary|Correlation Coefficient Between Measures of Cognition (N-back Scores) and Performance on the Cambridge Neuropsychological Test Automated Battery (CANTAB) Tests: Spatial Working Memory Between Errors (SWMBE) and Spatial Working Memory Strategy (SWMS)|"The n-back was used to assess cognition 3 times a day. Participants responded by touching the watch face when a symbol matched the one presented 2-back. Average daily n-back score (d-prime) was calculated.~CANTAB tests consists of a battery of neuropsychological tests. Spatial Working Memory (SWM) assessed retention of spatial data, ability to manipulate remembered items and strategize. Participant was asked to find tokens in on-screen boxes and move them.~SWMBE=cumulative number of times participant went back to box that a token was previously removed per each successful study. Lower score was better.~SWMS=number of unique boxes participant searched in two 6 and 8 box trials. Total of 4 trial scores ranged from 4-28. Lower score indicated better performance.~Pearson's correlation coefficient measured linear correlation between n-back scores from Apple Watch and CANTAB tests, provided as a value +1=positive correlation to -1=negative correlation. 0=no correlation."|Baseline up to Week 6|Analysis population included all participants with major depressive disorder (MDD) who were enrolled in the study.|||Correlation Coefficient (r)||95% Confidence Interval|Number
2539721|NCT03067506|Primary|Percentage of Days on Which Daily Mood Assessment Tests Were Completed|The Daily Mood assessments were completed on the wearable technology (Apple watch) once per day in the afternoon or evening.|Baseline up to Week 6|Analysis population included all participants with major depressive disorder (MDD) who were enrolled in the study.|||percentage of days||Standard Deviation|Mean
2539722|NCT03067506|Primary|Percentage of Days on Which Daily N-back Sessions Were Completed|The cognitive assessment n-back test was completed on the wearable technology (Apple watch) on 3 occasions across the day in the morning, afternoon and evening.|Baseline up to Week 6|Analysis population included all participants with major depressive disorder (MDD) who were enrolled in the study.|||percentage of days||Standard Deviation|Mean
2539723|NCT03066999|Secondary|Cost to Use Cystoscope Versus DirectVision|The investigators will look at the cost using the DirectVision versus the cystoscope with costs of ancillary tools used during the procedures.|7 months||||Cost in dollars per patient||Full Range|Mean
2539724|NCT03066999|Primary|Presence of Pain and Hematuria|To compare DirectVision to the cystoscope we compared if patients experienced pain or hematuria|duration of procedure||||participants|||Number
2539725|NCT03066999|Primary|Degree of Difficulty|Degree of difficulty defined as easy versus difficult|duration of procedure||||Participants|||Count of Participants
2539726|NCT03066999|Primary|Procedure Findings|"Procedure findings~1- Obliterated urethra~2-High bladder neck~3-Normal urethra~4-Urethral stricture~5-Bladder neck contracture"|duration of procedure||||participants|||Number
2539727|NCT03066999|Primary|Ancillary Tools Used|Ancillary tools used wire, SPT, etc|duration of procedure||||tools|||Number
2539728|NCT03066999|Primary|Effectiveness of DirectVision-adverse Events|assessment will be done by reviewing the number of Participants who had adverse events that are related to the procedures.|7 months||||Participants|||Count of Participants
2539729|NCT03066999|Primary|Set up Time/Total Procedure Time to Place Catheter Via DirectVision/Cystoscope|Duration to set up and complete the procedure either by DirectVision or Cystoscope was observed and calculated by minutes.|prep and duration of procedure, up to 1 hour||||minutes||Full Range|Mean
2539730|NCT03066622|Secondary|Number of Participants That Receive Peripheral Intravenous Catheterization|Determining if patients randomized to rapidly dissolving Olanzapine eventually require IV access, defined as A successful cannulation (blood return or ability to infuse intravenous fluid without infiltration) on initial percutaneous needle puncture|Length of Emergency Department stay (Time Frame: up to 12 hours)|Subjects consenting to participate in the study through time of ED discharge with complete data.|||Participants|||Count of Participants
2539731|NCT03066622|Secondary|Comparison of Duration of ED Length of Stay|The total time the patient spent in the ED after initially being seen by the physician|Length of Emergency Department stay (Time Frame: up to 12 hours)|Data was only available for 60 subjects in the standard of care arm and 58 subjects in the olanzapine arm.|||Minutes||Standard Deviation|Mean
2539732|NCT03066622|Primary|Change in Pain Scores Based on Patient Questionnaire|Change in patient reported pain score from baseline using the Numeric Pain Rating Scale (PNRS) Minimum score = 0 Maximum score = 10 Lower score indicates lower pain level, with zero indicating no pain and 10 indicating the worst pain imaginable.|baseline, 30, 60, and 90 minutes post drug administration|Not all participants were assessed at each time point due to some being discharged from the Emergency Department prior to study data collection time points.|||units on a scale of 1-10||Standard Deviation|Mean
2539733|NCT03066609|Secondary|Time to PASI 75 Response up to Week 12|Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|week 12|full analysis set|||days||95% Confidence Interval|Median
2539734|NCT03066609|Secondary|American Collage of Rheumatology (ACR) Response 20/50/70|Percentage of patients who achieved ACR 20/50/70 at Week 12 and up to Week 52. The subset of patients who had active PsA at baseline included 7 patients in the secukinumab 150 mg group, 17 patients in the secukinumab 300 mg group and 4 patients in the placebo group. ACR 20, 50 or 70 responses correspond, respectively, to at least 20%, 50% or 70% improvement in comparison with baseline in the number of tender and swollen joint counts, in addition to similar improvements in at least three of five other measure of disability or disease activity|week 12, week 24, week 52|full analysis set|||Participants|||Count of Participants
2539735|NCT03066609|Secondary|PASI 50/75/90/100 and IGA Mod 2011 0 or 1 Response Over Time (Multiple Imputation)|Number (%) of subjects with PASI 50, PASI 75, PASI 90, PASI 100 and IGA mod 2011 0 or 1 response|week 1, week 12, week 24, week 52|full analysis set|||Participants|||Count of Participants
2539736|NCT03066609|Secondary|Efficacy of Secukinumab in Maintaining IGA Mod 2011 0 or 1 Response at Week 52 in Subjects Who Were IGA Mod 2011 0 or 1 Responders at Week 12 (Multiple Imputation)|Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.|Week 52|full analysis set with measure|||Participants|||Count of Participants
2539737|NCT03066609|Secondary|Efficacy of Secukinumab in Maintaining PASI 75 Response at Week 52 in Subjects Who Were PASI 75 Responders at Week 12 (Multiple Imputation)|Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Week 52|full analysis set with measure|||Participants|||Count of Participants
2539738|NCT03066609|Secondary|Psoriasis Area and Severity Index (PASI) 90 (Multiple Imputation)|Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Week 12|full analysis set|||Participants|||Count of Participants
2539739|NCT03066609|Primary|Investigator`s Global Assessment (IGA) Mod 2011 0/1 (Multiple Imputation)|Investigator assessed disease using a validated scale (IGA mod 2011) and rate the disease from a score of 0 (clear skin) to 4 (severe disease). result given in terms of count of participants with response in 100 imputations. The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.|Week 12|full analysis set|||Participants|||Count of Participants
2539740|NCT03066609|Primary|Psoriasis Area and Severity Index (PASI) 75 (Multiple Imputation)|Psoriasis Area and Severity Index (PASI) was assessed/calculated as per usual standard. result given in terms of count of participants with response in 100 imputations. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Week 12|full analysis set|||Participants|||Count of Participants
2539741|NCT03066193|Primary|Changes in Tic Severity|Yale Global Tic Severity Scale (YGTSS) (Total Tic Score) The YGTSS tool gives ratings in 5 domains: Total Motor Tic Score, Total Verbal Tic Score, Total Tic Score (Motor + Verbal), Overall Impairment Rating, and Global Severity Score. When calculating the Global Severity score, it is found by adding together the total motor, verbal and impairment scores. The Total Tic Severity Score has a range of 0-50, and the Global Severity Score has a range of 0- 100. A higher score on all scales suggests a more severe Tic, or a greater impact the Tic has on the person's life.|12 weeks||||score on a scale||95% Confidence Interval|Mean
2539742|NCT03066102|Secondary|Change From Baseline in Scapular Muscle Recruitment Timing During Arm Elevation in Scapular Plane|"Test the ability of muscle onset timing (upper trapezius, lower trapezius, and serratus anterior) during shoulder elevation in the scapular plane (scaption).~Onset timing was determined by EMG signals bigger than resting signals plus 3 times standard deviations.~Origin was set at onset of kinematics data of glenohumeral joint."|through fatigue intervention completion, an average of 20 minutes in female subjects and 40 minutes in male subjects||||millisecond||Standard Deviation|Mean
2539743|NCT03066102|Secondary|Change From Baseline in Scapular Muscle Activity During Shoulder Elevation in the Scapular Plane|"Test the ability of muscle activity (upper trapezius, lower trapezius, and serratus anterior) during shoulder elevation in the scapular plane (scaption).~Muscle activation during scaption would divide into muscle activation during maximum voluntary isometric contraction (MVIC), present in percent."|through fatigue intervention completion, an average of 20 minutes in female subjects and 40 minutes in male subjects||||percentage of MVIC||Standard Deviation|Mean
2539819|NCT03064113|Secondary|Area Under the FEV1 vs. Peak FEV1, Time-matched Difference From Placebo||12 hr and 24 hr||||hr*mL||Standard Error|Least Squares Mean
2539746|NCT03066102|Primary|Change From Baseline in Muscle Activation During Scapular Proprioception|"Test the ability of muscle activation (upper trapezius, lower trapezius, and serratus anterior) during active re-position the scapula from neutral to 90% range of protraction, and elevation.~Muscle activation during active re-position would divide into muscle activation during maximum voluntary isometric contraction (MVIC), present in percent."|through fatigue intervention completion, an average of 20 minutes in female subjects and 40 minutes in male subjects||||percentage of MVIC||Standard Deviation|Mean
2539747|NCT03066102|Primary|Change From Baseline in Scapular Proprioception|Test the ability of active re-position the scapula from neutral to 90% range of protraction, and elevation.|through fatigue intervention completion, an average of 20 minutes in female subjects and 40 minutes in male subjects||||centimeters||Standard Deviation|Mean
2539748|NCT03065933|Primary|Score on a Mania Rating Scale|Mania rating scale to be performed each day of this 3 day study.|3 days|No data was collected on the 5 participants, except for region of enrollment, before the study terminated.||||||
2539749|NCT03065530|Secondary|Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping|visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS-C was assessed when the patient required oxytocin after surgery in supine position|24h after cesarean section.||||score on a scale||Standard Deviation|Mean
2539750|NCT03065530|Secondary|Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping|visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS-C was assessed when the patient required oxytocin after surgery in supine position|12h after cesarean section.||||score on a scale||Standard Deviation|Mean
2539751|NCT03065530|Secondary|Postoperative Pain Score (Visual Analogue Scale, VAS) on Uterine Cramping|visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS-C was assessed when the patient required oxytocin after surgery in supine position|6h after cesarean section.||||score on a scale||Standard Deviation|Mean
2539752|NCT03065530|Secondary|Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement|visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position.|48h after cesarean section.||||score on a scale||Standard Deviation|Mean
2539753|NCT03065530|Secondary|Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement|visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position.|24h after cesarean section.||||score on a scale||Standard Deviation|Mean
2539754|NCT03065530|Secondary|Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement|visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position.|12h after cesarean section.||||score on a scale||Standard Deviation|Mean
2539755|NCT03065530|Secondary|Postoperative Pain Score (Visual Analogue Scale, VAS) on Movement|visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS on movement was assessed when patients changed from supine to lateral position.|6h after cesarean section.||||score on a scale||Standard Deviation|Mean
2539756|NCT03065530|Secondary|Postoperative Pain Score (Visual Analogue Scale, VAS)|visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position|48h after cesarean section.||||score on a scale||Standard Deviation|Mean
2539757|NCT03065530|Secondary|Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest|visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position|24h after cesarean section.||||score on a scale||Standard Deviation|Mean
2539758|NCT03065530|Secondary|Ramsay Sedation Score(RSS)|Sedation intensity measured with RSS is recorded at the 6, 12, 24, and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus).|48h after cesarean section.||||score on a scale||Standard Deviation|Mean
2539759|NCT03065530|Secondary|Ramsay Sedation Score(RSS)|Sedation intensity measured with RSS is recorded at the 6, 12, 24, and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus).|24h after cesarean section.||||score on a scale||Standard Deviation|Mean
2539760|NCT03065530|Secondary|Ramsay Sedation Score(RSS)|Sedation intensity measured with RSS is recorded at the 6, 12, 24, and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus).|12h after cesarean section.||||score on a scale||Standard Deviation|Mean
2539761|NCT03065530|Secondary|Number of Participants That Experienced Nausea or Vomiting|Total times during 48h after cesarean section.|48h after cesarean section.||||participants|||Number
2539762|NCT03065530|Secondary|The Degree of Satisfaction|The degree of satisfaction (0, very satisfied; 1, satisfied; 2, moderately satisfied; 3, not satisfied) was evaluated at 48 h after surgery. The number of overall satisfied patients (satisfied and very satisfied) is reported.|48h after cesarean section.||||Participants|||Count of Participants
2539763|NCT03065530|Secondary|Ramsay Sedation Score(RSS)|Sedation intensity measured with RSS is recorded at the 6, 12 24 and 48 h after cesarean section. Sedation was assessed by the Ramsay Sedation Scores (RSS) (1, anxious patient; 2, cooperative and tranquil; 3, responding to command; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus).|6h after cesarean section.||||score on a scale||Standard Deviation|Mean
2539764|NCT03065530|Secondary|Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest|visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position|12h after cesarean section.||||score on a scale||Standard Deviation|Mean
2539765|NCT03065530|Secondary|Relative Infant Dose (RID) of Dexmedetomidine|Relative infant dose (RID) =Dose (infant, mg•kg-1•day-1) /Dose (mother, mg•kg-1•day-1) μg·kg-1·h-1. The Dose (infant) in mg•kg-1 is calculated by multiplying the concentration of the drug in breast milk by the volume of breast milk consumed daily (about 150 mL•kg-1).|48h after cesarean section.||||percentage of one hundred||Standard Deviation|Mean
2539766|NCT03065530|Primary|Postoperative Pain Score (Visual Analogue Scale, VAS) at Rest|visual analogue scale (VAS; with 0, no pain; to 10, the worst imaginable pain) is a validated assessing scale for pain intensity. VAS at rest was assessed when the patient was in supine position|6h after cesarean section.||||units on a scale||Standard Deviation|Mean
2539767|NCT03065283|Other Pre-specified|Maximum Respiratory Pressure|manovacuometer was used as an evaluation tool.|baseline and immediately post-intervention|||||||
2539768|NCT03065283|Other Pre-specified|Posterior Chain Flexibility|Tape measure was used as an evaluation tool.|baseline and immediately post-intervention|||||||
2539769|NCT03065283|Other Pre-specified|Amplitude of Motion of the Lumbar Spine|Tape measure was used as an evaluation tool.|baseline and immediately post-intervention|||||||
2539770|NCT03065283|Primary|Thoracic Mobility|Thoracic mobility was measued with a tape as an evaluation tool.|baseline and immediately post-intervention||||cm||Standard Deviation|Mean
2539771|NCT03065205|Secondary|Effectiveness of Communication Between Providers|measured via survey to providers at the end of the intervention|6 months||||Participants|||Count of Participants
2539772|NCT03065205|Secondary|Barriers to Adherence of Patient Asthma Inhalers|Measured via questionnaire data obtained every 2 months. Reported at 6 months.|6 months||||Participants|||Count of Participants
2539773|NCT03065205|Secondary|Degree of Asthma Control|Measured via questionnaire data using Asthma Control Test (ACT) or Childhood Asthma Control Test (cACT) every 2 months. Reported at 6 months. Scores range from 5-25 on the ACT and 0-27 on the cACT. Scores >19 on either test indicate good asthma control|6 months|Total number of participants who responded to the 6 month survey.|||score on a scale||Standard Deviation|Mean
2539774|NCT03065205|Primary|Change in Adherence of Use of Patient Asthma Inhalers|Adherence will be measured via adherence monitoring devices for 6 months per patient. Change in device measured adherence from week 1 to week 24. Measured as change in average number of puffs of controller medication taken/puffs individually prescribed, measured between weeks 1 and 24.|Week 1 to Week 24|Participants who were in the study for the 6 month period and had analyzable study data for at least 16 weeks of monitored time.|||Change in puffs taken/prescribed per wk||Inter-Quartile Range|Median
2539775|NCT03065075|Other Pre-specified|Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (AS-TREATED)|Rate of postoperative urinary retention after pelvic organ prolapse surgery as determined by those who failed a standardized void trial. A successful void trial is defined as a postvoid residual of less than half of the voided volume.|postoperative day 1|As-treated analysis|||Participants|||Count of Participants
2539776|NCT03065075|Primary|Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (INTENT-TO-TREAT)|Rate of postoperative urinary retention after pelvic organ prolapse surgery as determined by those who failed a standardized void trial. A successful void trial is defined as a postvoid residual of less than half of the voided volume.|postoperative day 1|Intent-to-treat analysis|||Participants|||Count of Participants
2539777|NCT03065023|Other Pre-specified|Immune Infiltration of Injected Tumors by CD3 T Cell Receptor and Ki-67 Nuclear Protein: Day 25|Sequential participant tumor biopsies were assessed via immunohistochemistry for the presence of tumor infiltrating CD3 T cell co-receptor-marked cells and Ki-67 nuclear protein-marked cells in tumor biopsies. CD3 is a marker of T cells and KI-67 is a cell marker of proliferation and activation. The percentage of positive CD3-marked cells and double-positive CD3 and Ki-67 nuclear protein-marked cells in tumor biopsies postdose on Day 25 are presented.|Day 25 post injection (Up to 25 days)|The immune infiltration evaluable population consisted of all participants who received ≥1 dose of MK-4621 and had pre- and post-treatment immune infiltration data.|||Percentage Positive Cells||Full Range|Median
2539778|NCT03065023|Other Pre-specified|Immune Infiltration of Injected Tumors by CD3 T Cell Receptor and Ki-67 Nuclear Protein: Day 1|Sequential participant tumor biopsies were assessed via immunohistochemistry for the presence of tumor infiltrating CD3 T cell co-receptor-marked cells and Ki-67 nuclear protein-marked cells in tumor biopsies. CD3 is a marker of T cells and KI-67 is a cell marker of proliferation and activation. The percentage of positive CD3-marked cells and double-positive CD3 and Ki-67 nuclear protein-marked cells in tumor biopsies predose on Day 1 are presented.|Day 1 prior to injection (Up to 1 day)|The immune infiltration evaluable population consisted of all participants who received ≥1 dose of MK-4621 and had pre- and post-treatment immune infiltration data.|||Percentage Positive Cells||Full Range|Median
2539779|NCT03065023|Other Pre-specified|Maximum Plasma Concentration (Cmax) of MK-4621: Day 25|Blood samples were collected at various time points during Cycle 1 for the determination of MK-4621 Cmax on Day 25.|Cycle 1 Day 25: Predose, 5 and 30 minutes, 2, 4, 6 and 24 hours post dose (Up to 26 days); Each cycle was 28 days.|The pharmacokinetic evaluable population consisted of all participants who received ≥1 injection of MK-4621 and had pre- and post-treatment pharmacokinetic data for Cmax on Cycle 1 Day 25.|||ng/mL||Standard Deviation|Mean
2539780|NCT03065023|Other Pre-specified|Maximum Plasma Concentration (Cmax) of MK-4621: Day 1|Blood samples were collected at various time points during Cycle 1 for the determination of MK-4621 Cmax on Day 1.|Cycle 1 Day 1: Predose, 5 and 30 minutes, 2, 4, 6 and 24 hours post dose (Up to 2 days); Each cycle was 28 days.|The pharmacokinetic evaluable population consisted of all participants who received ≥1 injection of MK-4621 and had pre- and post-treatment pharmacokinetic data for Cmax on Cycle 1 Day 1.|||ng/mL||Standard Deviation|Mean
2539781|NCT03065023|Other Pre-specified|Area Under the Concentration-Time Curve From Start of Dosing to Last Observed Concentration Above Limit of Quantitation (AUC0-t) of MK-4621: Day 25|Blood samples were collected at various time points during Cycle 1 for the determination of MK-4621 AUC0-t on Day 25, which was defined as the AUC from the start time of dosing to the time of the last observed concentration above the limit of quantitation (LOQ).|Cycle 1 Day 25: Predose, 5 and 30 minutes, 2, 4, 6 and 24 hours post dose (Up to 26 days); Each cycle was 28 days.|The pharmacokinetic evaluable population consisted of all participants who received ≥1 injection of MK-4621 and had pre- and post-treatment pharmacokinetic data for AUC0-t on Cycle 1 Day 25.|||h*ng/mL||Standard Deviation|Mean
2539782|NCT03065023|Other Pre-specified|Area Under the Concentration-Time Curve From Start of Dosing to Last Observed Concentration Above Limit of Quantitation (AUC0-t) of MK-4621: Day 1|Blood samples were collected at various time points during Cycle 1 for the determination of MK-4621 AUC0-t on Day 1, which was defined as the AUC from the start time of dosing to the time of the last observed concentration above the limit of quantitation (LOQ).|Cycle 1 Day 1: Predose, 5 and 30 minutes, 2, 4, 6 and 24 hours post dose (Up to 2 days); Each cycle was 28 days.|The pharmacokinetic evaluable population consisted of all participants who received ≥1 injection of MK-4621 and had pre- and post-treatment pharmacokinetic data for AUC0-t on Cycle 1 Day 1.|||h*ng/mL||Standard Deviation|Mean
2539783|NCT03065023|Other Pre-specified|Mean Fold Change From Baseline in Plasma Cytokine Release by Cytokine Type: Day 25 (24 Hours Post Injection)|Blood samples were collected at various time points for the analysis of mean fold change from baseline in cytokine release for selected cytokines (Interleukin-6 [IL-6] and tumor necrosis factor-alpha [TNF-a]) in plasma.|Baseline and Cycle 1 Day 25 (24 hours post injection) (Up to 26 days); Each cycle was 28 days.|The cytokine evaluable population consisted of all participants who received ≥1 dose of MK-4621 and had baseline and post treatment cytokine data.|||Fold change||Standard Deviation|Mean
2539784|NCT03065023|Other Pre-specified|Mean Fold Change From Baseline in Plasma Cytokine Release by Cytokine Type: Day 25 (6 Hours Post Injection)|Blood samples were collected at various time points for the analysis of mean fold change from baseline in cytokine release for selected cytokines (Interleukin-6 [IL-6] and tumor necrosis factor-alpha [TNF-a]) in plasma.|Baseline and Cycle 1 Day 25 (6 hours post injection) (Up to 25 days); Each cycle was 28 days.|The cytokine evaluable population consisted of all participants who received ≥1 dose of MK-4621 and had baseline and post treatment cytokine data.|||Fold change||Standard Deviation|Mean
2539785|NCT03065023|Other Pre-specified|Mean Fold Change From Baseline in Plasma Cytokine Release by Cytokine Type: Day 1 (24 Hours Post Injection)|Blood samples were collected at various time points for the analysis of mean fold change from baseline in cytokine release for selected cytokines (Interleukin-6 [IL-6] and tumor necrosis factor-alpha [TNF-a]) in plasma.|Baseline and Cycle 1 Day 1 (24 hours post injection) (Up to 2 days); Each cycle was 28 days.|The cytokine evaluable population consisted of all participants who received ≥1 dose of MK-4621 and had baseline and post treatment cytokine data.|||Fold change||Standard Deviation|Mean
2539786|NCT03065023|Other Pre-specified|Mean Fold Change From Baseline in Plasma Cytokine Release by Cytokine Type: Day 1 (6 Hours Post Injection)|Blood samples were collected at various time points for the analysis of mean fold change from baseline in cytokine release for selected cytokines (Interleukin-6 [IL-6] and tumor necrosis factor-alpha [TNF-a]) in plasma.|Baseline and Cycle 1 Day 1 (6 hours post injection) (Up to 1 day); Each cycle was 28 days.|The cytokine evaluable population consisted of all participants who received ≥1 dose of MK-4621 and had baseline and post treatment cytokine data.|||Fold change||Standard Deviation|Mean
2539787|NCT03065023|Secondary|Objective Response Rate as Evaluated Radiologically Using Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)|ORR was defined as the percentage of participants who had a Complete Response (CR) or a Partial Response. Per irRECIST, CR (irCR) was defined as the complete disappearance of all measurable and non-measurable lesions. Lymph nodes must also have decreased to <0 mm in short axis. And, per irRECIST, Partial Response (irPR) was defined as a decrease of ≥30% in total measured tumor burden (TMTB) relative to baseline. For this study, irRECIST was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced an irCR or irPR based on irRECIST is presented.|Up to 60 days post last injection (Up to approximately 162 days)|The efficacy population consisted of all allocated participants.|||Percentage of Participants||95% Confidence Interval|Number
2539788|NCT03065023|Primary|Number of Participants Who Experienced a Dose-limiting Toxicity (DLT) by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria|"DLTs were assessed during the first treatment cycle (28 days) & were defined as any drug-related toxicity that occurred during the 28-day DLT period and included:~Non-hematologic toxicity grade ≥3 (except diarrhea, nausea, and vomiting unless lasting >3 days despite optimal supportive care);~Confirmed (with a second measurement after 24 hours) non-hematologic appropriately graded laboratory findings of Grade ≥3 that were ≤ Grade 1 at baseline;~Hematologic toxicity:~Grade 4 neutropenia ≥5 days, or Grade 3 neutropenia with fever (fever is >38.4ºC)~Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia lasting >7 days or with bleeding; and~Any other toxicity assessed as related to MK-4621, and which, in the opinion of the Investigator and the Sponsor physician constituted a DLT.~The number of participants who experienced a DLT is presented by NCI CTCAE version 4.03 severity grade."|Cycle 1 (Up to approximately 28 days); Each cycle was 28 days.|The DLT evaluable population consisted of participants who completed Cycle 1 (Day 28) or withdrew early for experiencing a DLT.|||Participants|||Count of Participants
2539789|NCT03065023|Primary|Number of Participants Who Discontinued Study Treatment Due to a Treatment-related Adverse Event (AE)|"An AE was defined as any untoward medical occurrence in a study participant administered a study treatment which did not necessarily have a causal relationship with this treatment. Treatment-related was defined as having a Possible or Related relationship to study treatment, as assessed by the Investigator. The number of participants who discontinued study treatment due to a treatment-related AE is presented."|Up to last injection (Up to approximately 102 days)|The safety population consisted of all participants who received ≥1 injection of MK-4621.|||Participants|||Count of Participants
2539790|NCT03065023|Primary|Number of Participants Who Experienced a Serious Adverse Event (SAE)|"A SAE was defined as any AE, regardless of dose, causality or expectedness, that:~Resulted in death;~Was life-threatening;~Required inpatient hospitalization or prolonged existing inpatient hospitalization;~Resulted in persistent or significant incapacity or disability;~Was a congenital anomaly or birth defect; or~Was any other medically important event."|Up to 90 days post last injection (Up to approximately 192 days)|The safety population consisted of all participants who received ≥1 injection of MK-4621.|||Participants|||Count of Participants
2539820|NCT03064113|Secondary|Area Under the FEV1 vs. Time Curve, Time-matched Difference From Placebo||12 hr and 24 hr||||mL||Standard Error|Least Squares Mean
2539821|NCT03064113|Primary|Peak Forced Expiratory Volume in One Second (FEV1) Relative to Baseline||From predose to 25 hours postdose||||mL||Standard Error|Least Squares Mean
2539791|NCT03065023|Primary|Number of Participants Who Experienced a Treatment-related Adverse Event (AE) or Laboratory Abnormality by Severity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Criteria|"An AE was defined as any untoward medical occurrence in a study participant administered study treatment which did not necessarily have a causal relationship with this treatment. Treatment-related was defined as having a Possible or Related relationship to study treatment, as assessed by the Investigator. Severity of AE referred to the extent to which an AE affected the participants daily activities as assessed by the Investigator and was based on NCI CTCAE grades: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe or medically significant but not immediately life-threatening); Grade 4 (Life-threatening consequences); or Grade 5 (Death related to AE). The number of participants who experienced at least one treatment-related AE or laboratory abnormality are presented by severity."|Up to 90 days post last injection (Up to approximately 192 days)|The safety population consisted of all participants who received ≥1 injection of MK-4621.|||Participants|||Count of Participants
2539792|NCT03064841|Secondary|Follow up Duration of Type 2 Diabetes Related Risk Factors in Clinical Practice|The follow up duration of type 2 diabetes related risk factors was summarized using the situation of lab test including serum creatinine, uric acid, high density lipoprotein cholesterol, low density lipoprotein cholesterol, triglyceride and total cholesterol.|At study visit (one day)|FAS - E|||Percentage of patients|||Number
2539793|NCT03064841|Secondary|Percentage of Patients With Anti-platelet Therapy Usage|The percentage of patients with anti-platelet therapy usage.|At study visit (one day)|FAS - E|||Percentage of patients|||Number
2539794|NCT03064841|Secondary|Percentage of Patients With Lipid Lowering Therapy Usage|The percentage of patients with lipid lowering therapy usage.|At study visit (one day)|FAS - E|||Percentage of patients|||Number
2539795|NCT03064841|Secondary|Percentage of Patients With Anti-hypertension Therapy Usage|The percentage of patients with anti-hypertension therapy usage.|At study visit (one day)|FAS - E|||Percentage of patients|||Number
2539796|NCT03064841|Secondary|Percentage of Patients With Hypoglycaemia Leading to Therapy Change|The percentage of patients with hypoglycaemia leading to therapy change.|At study visit (one day)|FAS - E|||Percentage of patients|||Number
2539797|NCT03064841|Secondary|Percentage of Patients With Hypoglycaemic Occurrence|The percentage of patients with hypoglycaemic occurrence.|At study visit (one day)|FAS - E|||Percentage of patients|||Number
2539798|NCT03064841|Secondary|Percentage of Patients Macro-vascular and Micro-vascular Diabetic Complications|The percentage of patients macro-vascular and micro-vascular diabetic complications.|At study visit (one day)|FAS - E|||Percentage of patients|||Number
2539799|NCT03064841|Secondary|Treatment Regimens for T2DM That Patient Are Currently Taking|The treatment regimens for T2DM that patient are currently taking.|At study visit (one day)|FAS - E|||Percentage of patients|||Number
2539800|NCT03064841|Secondary|Renal Function Level of Patients Measured by Chronic Kidney Disease (CKD) Stage|The renal function level of patients was measured by CKD into following categories - eGFR ≥ 60 milliLitre/minute/1.73 meter ^ 2 (mL/min/1.73m^2), eGFR < 60 mL/min/1.73m^2 and missing data.|At study visit (one day)|FAS - E|||Percentage of patients|||Number
2539801|NCT03064841|Secondary|Renal Function Level of Patients Measured by Estimated Glomerular Filtration Rate (eGFR)|The renal function level of patients was measured by estimated glomerular filtration rate (eGFR).|At study visit (one day)|FAS - E|||milliLitre/minute/1.73 meter ^ 2||Standard Deviation|Mean
2539802|NCT03064841|Secondary|Renal Function Level of Patients Measured by Albuminuria|"The renal function level of patients was measured by albuminuria into following categories - normal, micro-albuminuria, macro-albuminuria and missing data.~Albuminuria was measured using either as a random spot urine sample, a 24-h urine sample, or a timed urine sample. Normal was defined as < 30 mg/g, <30 mg/24h, and < 20 μg/min with the random spot urine sample, the 24-h urine sample, and the timed urine sample, respectively. Micro-albuminuria was defined as 30 - 300 mg/g, 30 - 300 mg/24h, and 20 - 200 μg/min with the random spot urine sample, the 24-h urine sample, and the timed urine sample, respectively. Macro-albuminuria was defined as >300 mg/g, >300 mg/24h, and >200 μg/min with the random spot urine sample, the 24-h urine sample, and the timed urine sample, respectively."|At study visit (one day)|FAS - E|||Percentage of patients|||Number
2539803|NCT03064841|Primary|Percentage of Patients Attained Blood Glucose Control Target Defined as Glycated Haemoglobin A1c (HbA1c)<7%, According to 2015 American Diabetes Association (ADA) and 2013 Chinese Diabetes Society (CDS) Guidelines.|The percentage of patients attaining blood glucose control target defined as HbA1c<7%, according to 2015 American Diabetes Association (ADA) and 2013 Chinese Diabetes Society (CDS) guidelines.|At study visit (one day)|"Full Analysis Set - Eligible (FAS - E):~The FAS - E includes all eligible patients regarding to inclusion and exclusion criteria with an glycated haemoglobin A1c (HbA1c) measurement."|||Percentage of patients|||Number
2539804|NCT03064451|Secondary|Number of Participants With Procedural Related Serious Adverse Event and Non-serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with treatment and therefore can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with use of a medicinal product, whether or not related to that medicinal product. TEAEs were defined as AEs that were reported or worsened on after start of study drug(s) dosing through safety follow-up visit. A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulting in any of following outcomes: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.|Up to 12 months|The safety participants population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted, regardless if CARTOFINDER-guided ablation was performed.|||Participants|||Count of Participants
2539822|NCT03063476|Secondary|Peak Urinary 2-AAA Concentration Percentage Change From Baseline|Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified relative to standard.|Baseline and 2-6 hours||||Percentage change||Standard Deviation|Mean
2540480|NCT03047174|Secondary|Number of Participants With Grade ≥3 Radiation Dermatitis at 50 Gy (Per Protocol Set)|Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.|at 50 Gy (about 5 weeks)|Per Protocol Set|||Participants|||Count of Participants
2539805|NCT03064451|Secondary|Number of Participants With Adverse Device Effects (ADEs) up to 12 Months|Number of participants with adverse device effects was reported. Adverse Device Effect (ADE's) are adverse events related to the use of an investigational medical device. This definition includes adverse events resulting from insufficient or inadequate instructions for use deployment, implantation, installation, or operation, or any malfunction of the investigational medical device. This definition includes any event resulting from use errors or from intentional misuse of the investigational medical device.|Up to 12 months|The safety participants population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted, regardless if CARTOFINDER-guided ablation was performed.|||Participants|||Count of Participants
2539806|NCT03064451|Secondary|Number of Participants With All Serious Adverse Events (SAEs) up to 12 Months|Number of participants with SAEs will be evaluated. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.|Up to 12 months|The safety participants population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted, regardless if CARTOFINDER-guided ablation was performed.|||Participants|||Count of Participants
2539807|NCT03064451|Secondary|Number of Participants With Serious Adverse Device Effects (SADEs) up to 12 Months|Any serious adverse event which was related to the device and/or the procedure was defined as a SADE.|Up to 12 months|The safety participants population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted, regardless if CARTOFINDER-guided ablation was performed.|||Participants|||Count of Participants
2539808|NCT03064451|Secondary|Change of Intra-cycle Length From Pre-CFGA (Baseline) to Post-CFGA and Post-PVI|Change of intra-cycle length from pre-CFGA to post-CFGA and post-PVI is reported to measure the slowing for the overall Atrial Fibrillation rate in both atrium's.|Pre-CFGA (Baseline) to Post-CFGA and Post-PVI (Up to 7 days)|Evaluable participant included all enrolled participants who had RHYTHMFINDER 192 Catheter inserted, where CARTOFINDER-guided ablation was performed. Here 'n' (number analyzed) included participants analyzed at specified categories for post-CFGA and post PVI.|||milliseconds||Standard Deviation|Mean
2539809|NCT03064451|Secondary|Number of Participants With Confirmed Entrance Block After Adenosine/Isoproterenol Challenge|Number of participants with confirmed entrance block after adenosine/isoproterenol challenge was reported.|Up to 12 months|Evaluable participant population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted and where CARTOFINDER-guided ablation was performed. Here 'N' number of participants analyzed included participants with adenosine/isoproterenol challenge and non-missing confirmation of entry block data collected from the PVI form.|||Participants|||Count of Participants
2539810|NCT03064451|Primary|Number of Participants With Early-onset Primary Adverse Events|Incidence of early-onset (within 7 days of the initial mapping and ablation procedure) Primary Adverse Events (PAEs) was reported. PAEs included death, Atria-Esophageal Fistula, Cardiac Tamponade/Perforation, Myocardial Infarction, Stroke/Cerebrovascular Accident, Thromboembolism, Transient Ischemic Attack, Diaphragmatic Paralysis, Pneumothorax, Heart Block, Pulmonary Vein Stenosis, Pulmonary Edema (Respiratory Insufficiency), Pericarditis and Major Vascular Access Complication/Bleeding.|Up to 7 days|The safety participants population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted, regardless if CARTOFINDER-guided ablation was performed.|||Participants|||Count of Participants
2539811|NCT03064451|Primary|Percentage of Participants With Recurrence of Atrial Fibrillation, Atrial Flutter, and Atrial Tachycardia Episodes of Greater Than or Equal to (>=) 30 Seconds to Measure the Effectiveness Success Rate for up to 12 Months|Documented AF/AT/AFL recurrence is defined as any occurrence of documented (symptomatic) atrial fibrillation, atrial flutter, and atrial tachycardia episodes >= 30 seconds during the post-blanking period (Day 91-365). Here 'HM' signifies Holter monitoring.|Up to 12 months|Evaluable population:enrolled participants who had RHYTHMFINDER 192 Catheter inserted, where CFGA performed. 'N' (Number of participants analyzed):number of participants who completed 12 months follow-up(post initial ablation) or data collected from ElectroCardioGram, HM, or Post Procedure Arrhythmia Log forms beyond 337 days post index procedure.|||Percentage of participants|||Number
2539812|NCT03064451|Primary|Percentage of Participants With Procedural Success|Procedural success defined as the conversion of Atrial Fibrillation to Normal Sinus Rhythm or Atrial Tachycardia after overall ablation procedure, with or without the need for cardioversion.|Up to 7 days|The evaluable participant population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted and where CARTOFINDER-guided ablation was performed.|||Percentage of participants|||Number
2539813|NCT03064451|Primary|Percentage of Participants With Acute Success Post CartoFinder Guided Ablation (CFGA) and Pulmonary Vein Isolation (PVI) Without Cardioversion|Acute success defined as rate of conversion of Atrial Fibrillation to Normal Sinus Rhythm or Atrial Tachycardia, after CFGA and PVI without Cardioversion.|Up to 7 days|The evaluable participant population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted and where CARTOFINDER-guided ablation was performed.|||Percentage of participants|||Number
2539814|NCT03064451|Primary|Percentage of Participants With Acute Success Post CartoFinder Guided Ablation (CFGA) Only (Before Pulmonary Vein Isolation [PVI] and Without Cardioversion).|Acute success defined as rate of conversion of Atrial Fibrillation to Normal Sinus Rhythm or Atrial Tachycardia, after CARTOFINDER Guided Ablation (CFGA) only (before Pulmonary Vein Isolation [PVI] and without cardioversion).|Up to 7 days|The evaluable participant population included all enrolled participants who had the RHYTHMFINDER 192 Catheter inserted and where CARTOFINDER-guided ablation was performed.|||Percentage of participants|||Number
2539815|NCT03064113|Secondary|Area Under the Forced Vital Capacity (FVC) vs. Time Curve||0-24 hours||||hr*mL||Standard Error|Least Squares Mean
2539816|NCT03064113|Secondary|Forced Vital Capacity (FVC)||From predose to 25 hours postdose||||mL||Standard Deviation|Mean
2539817|NCT03064113|Secondary|Forced Expiratory Flow From 25% to 75% of Vital Capacity (FEF25−75), as Related to FEV1||12hr and 24hr||||L/sec||Standard Error|Least Squares Mean
2539818|NCT03064113|Secondary|Peak Expiratory Flow Rate (PEFR) From 25% to 75% of Vital Capacity (FEF25−75), as Related to FEV1||12hr and 24hr||||L/sec||Standard Error|Least Squares Mean
2539823|NCT03063476|Primary|Peak Plasma 2-AAA Concentration Percentage Change From Baseline|Alpha aminoadipic acid (2-AAA) concentration determined through mass spectrometry, quantified relative to standard.|Baseline and 2-6 hours|Two healthy subjects (one male, one female; one black, one white) were enrolled and completed the study visit.|||Percentage Change||Standard Deviation|Mean
2539824|NCT03063437|Other Pre-specified|Engraftment Dynamics|To evaluate the trends in VRE type/strain-level engraftment using whole genome sequencing among those colonized|6 months following FMT|||||||
2539825|NCT03063437|Other Pre-specified|Microbiome Disruption|To evaluate the microbiome disruption index (MDI) by 16s rRNA sequencing): MDI-community and MDI-species|Day 3, day 10, week 4 after randomization.|||||||
2539826|NCT03063437|Secondary|Serious Adverse Events Within 6 Months Following FMT|Percentage of participants with a Serious Adverse Event (SAE)|Month 6 (±14 days) phone safety assessment after randomization||||Participants|||Count of Participants
2539827|NCT03063437|Secondary|Newly Acquired Transmissible Infectious Diseases Which Are Considered Adverse Events of Special Interest (AESI)|Percentage of participants with newly acquired transmissible infectious diseases which are considered adverse events of special interest (AESI)|Week 4 (±5 days) after randomization||||Participants|||Count of Participants
2539828|NCT03063437|Secondary|Serious Adverse Events Within 4 Weeks Following FMT|Percentage of participants with a serious adverse event (SAE)|Week 4 (±5 days) after randomization||||Participants|||Count of Participants
2539829|NCT03063437|Secondary|Adverse Events Within 4 Weeks Following FMT|Percentage of participants with an adverse event (AE)|Week 4 (±5 days) after randomization||||Participants|||Count of Participants
2539830|NCT03063437|Secondary|VRE Decolonization Among Immunocompromised Patients|Percentage of participants with VRE decolonization among immunocompromised patients|Day 10 (± 3 days) after randomization||||Participants|||Count of Participants
2539831|NCT03063437|Secondary|Number of Days Between FMT and VRE Colonization and Infection Occurs|Time (in days) from randomization until the study day when VRE colonization and infection occurs|Up to 6 months after randomization|Data not collected as no participants in the trial were colonized and infected by VRE following randomization.||||||
2539832|NCT03063437|Secondary|Percentage of Participants With ARB Infection 4 Weeks Following FMT|Percentage of participants with composite ARB infection|Week 4 (±5 days) after randomization|Data not collected as no participants in the trial entered the study colonized with an ARB other than VRE||||||
2539833|NCT03063437|Secondary|Percentage of Participants With ARB Colonization on Day 10 Following Fecal Microbiota Transplantation (FMT)|Percentage of participants with other antibiotic resistant bacteria (ARB) colonization|Day 10 (± 3 days) after randomization|Data not collected as no participants in the trial entered the study colonized with an ARB other than VRE||||||
2539834|NCT03063437|Secondary|Percentage of Participants With VRE Infection|Percentage of participants with VRE infection, defined as an associated bacteremia, urinary tract infection, or wound-related infection.|Week 4 (±5 days) after randomization||||Participants|||Count of Participants
2539835|NCT03063437|Primary|Percentage of Participants With an Adverse Event (AE); Severe Adverse Event (SAE); and Newly Acquired Transmissible Infectious Diseases Which Are Considered Adverse Events of Special Interest (AESI)|Percentage of participants with an adverse event (AE); severe adverse event (SAE); and newly acquired transmissible infectious diseases which are considered adverse events of special interest (AESI) through Day 10 (± 3 days) after randomization.|Day 10 (±3 days) after randomization||||Participants|||Count of Participants
2539836|NCT03063437|Primary|Percentage of Participants With VRE Decolonization|VRE decolonization is defined by absence of VRE on stool culture using standard clinical laboratory techniques at Day 10 (± 3 days) after randomization.|Day 10 (±3 days) after randomization||||Participants|||Count of Participants
2539837|NCT03063385|Primary|Change From Baseline to 12 Months in Parent - Adolescent Sexual Risk Communication (Parental Perspective)|Computer-based questionnaire reflecting parent-adolescent sexual risk communication. Data presented from the parental perspective. Questionnaire includes 7 items, each measured using a 5-point Likert scale, ranging from 1-5, where a higher score indicates more communication when talking about sexual topics. All primary outcome measures for this study were derived as the mean of the individual items, and was calculated for each participant when 75% or more of the items were completed. When less than 75% of the items were completed, the derived measure was considered incomplete and not included in the measurement. Change was calculated as parent-adolescent sexual risk communication at 12 months minus baseline.|Baseline - 12 months|"All participants for whom parent-adolescent sexual risk communication (parental perspective) were recorded at baseline and 12 months.~Note: for health promotion arm - 1 missing data at baseline)"|||units on a scale||Standard Deviation|Mean
2539838|NCT03063385|Primary|Change From Baseline to 6 Months in Parent - Adolescent Sexual Risk Communication (Parental Perspective)|Computer-based questionnaire reflecting parent-adolescent sexual risk communication. Data presented from the parental perspective. Questionnaire includes 7 items, each measured using a 5-point Likert scale, ranging from 1-5, where a higher score indicates more communication when talking about sexual topics. All primary outcome measures for this study were derived as the mean of the individual items, and was calculated for each participant when 75% or more of the items were completed. When less than 75% of the items were completed, the derived measure was considered incomplete and not included in the measurement. Change was calculated as parent-adolescent sexual risk communication at 6 months minus baseline.|Baseline - 6 months|"All participants for whom parent-adolescent sexual risk communication (parental perspective) were recorded at baseline and 6 months.~Note: for health promotion arm - 1 missing data at baseline)"|||units on a scale||Standard Deviation|Mean
2539849|NCT03062917|Primary|The Number of Sampling Visits on Which Participants Are Willing to Undergo Nasosorption and/or NPA Sampling|To determine the difference in tolerability of nasosorption compared to NPA by assessment of acceptance by infants and families. Samples were collected from participants up to twice daily throughout study involvement, as such each participant could have >1 sampling visits.|Throughout symptomatic respiratory infection, up to 1 month|Parents asked at each sampling timepoint on willingness to continue with respiratory sampling, as either: 1) both nasosorption and NPA, 2) just nasosorption, 3) just NPA, 4) discontinue sampling. This analysis includes all non-sedated hospitalised participants as sedation would influence the tolerability of sampling as perceived by parents/carers.|||Sampling visits|Number of individual sampling visits||Number
2539839|NCT03063385|Primary|Change From Baseline to 3 Months in Parent - Adolescent Sexual Risk Communication (Parental Perspective)|Computer-based questionnaire reflecting parent-adolescent sexual risk communication. Data presented from the parental perspective. Questionnaire includes 7 items, each measured using a 5-point Likert scale, ranging from 1-5, where a higher score indicates more communication when talking about sexual topics. All primary outcome measures for this study were derived as the mean of the individual items, and was calculated for each participant when 75% or more of the items were completed. When less than 75% of the items were completed, the derived measure was considered incomplete and not included in the measurement. Change was calculated as parent-adolescent sexual risk communication at 3 months minus baseline.|Baseline - 3 months|"All participants for whom parent-adolescent sexual risk communication (parental perspective) were recorded at baseline and 3 months.~Note: for Parental communication intervention arm - 2 missing data points at 3 months); for health promotion arm - 1 missing data at baseline)"|||units on a scale||Standard Deviation|Mean
2539840|NCT03063086|Secondary|Trough FEV1 After 21 Days of Treatment|To evaluate post-dose trough bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment in the respective treatment period. The trough FEV1 is the mean value of FEV1 at 23 h 15 min and 23 h 45 min post-dose|3 weeks|Pharmacodynamics set - The PD analysis set included all patients with any available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data|||Liters||Standard Error|Least Squares Mean
2539841|NCT03063086|Secondary|FEV1 AUC 5 Min - 1 h (Day 21) FEV1 AUC 5 Min - 4 h (Day 21) and FEV1 AUC 5 Min - 23 h 45 Min (Day 21)|To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/ fluticasone FDC by measuring standardized FEV1 AUCs after 3 weeks of treatment respective period.|3 weeks|Pharmacodynamics set - The PD analysis set included all patients with any available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data.|||Liters||Standard Error|Least Squares Mean
2539842|NCT03063086|Secondary|FEV1/FVC Ratio Over 24 h After 21 Days of Treatment in Relation to Evening Dose|To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment at -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min.|-45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min at 3 weeks|Pharmacodynamics set - The PD analysis set included all patients with any available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data.|||Ratio||Standard Deviation|Mean
2539843|NCT03063086|Secondary|FVC Over 24 h After 21 Days of Treatment in Relation to Evening Dose|To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment at -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min.|-45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min at 3 weeks|Pharmacodynamics set - The PD analysis set included all patients with any available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data.|||Liters||Standard Deviation|Mean
2539844|NCT03063086|Secondary|FEV1 Over 24 h After 21 Days of Treatment in Relation to Evening Dose|To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment at -45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min.|-45 min, -15 min, 5 min, 15 min, 30 min, 1 h, 2 h, 3h, 4 h, 8 h, 10 h, 11 h 55 min, 14 h, 18 h, 21 h, 23 h 15 min, 23 h 45 min at 3 weeks|Pharmacodynamics set - The PD analysis set included all patients with any available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data.|||Liters||Standard Error|Least Squares Mean
2539845|NCT03063086|Primary|Peak FEV1 (L) Defined as the Highest Bronchodilatory Effect on FEV1 During a Period of 5 Min to 4 h After the Last Evening Dose of Each Treatment Period|The highest bronchodilator effect on FEV1 during a period of 5 min to 4 h after the last evening dose of each treatment period . To demonstrate superiority in peak bronchodilator effect of QVM149 at a dose of 150/50/160 μg o.d. and 150/50/80 μg o.d. compared to a FDC of salmeterol/fluticasone at a dose of 50/500 μg b.i.d. after 3 weeks of treatment in patients with asthma|3 weeks|Pharmacodynamics set - The PD analysis set included all patients with any available PD data, who received any study treatment and experienced no protocol deviations with relevant impact on PD data.|||Liters||Standard Error|Least Squares Mean
2539846|NCT03062917|Primary|Accuracy of Bronchosorption for Viral Load Measurement, Compared to Tracheal Aspirate|To determine the difference in accuracy of bronchosorption (BSAM) compared to tracheal aspirate (TA) by assessment of level of viral load (measured by qPCR).|Throughout symptomatic respiratory infection, up to 1 month|Spearman R score correlation between RSV viral load as measured by bronchosorption and tracheal aspiration. This analysis includes all RSV+ infants independent of recruitment group as no differences in correlation between sample type were anticipated between recruitment group.|||Spearman R score|Number matched RSV+ BSAM and TA||Number
2539847|NCT03062917|Secondary|Immune Response|Establishing the use of nasal and bronchial sampling to measure the host immune response to RSV. We will determine cytokine and inflammatory mediator concentrations by immunoassay of eluted fluid from nasosorption and compare with NPA.|Throughout symptomatic respiratory infection, up to 1 month|Spearman R score correlation of Interferon-gamma levels in matched nasosorption and NPA samples from any participant. This analysis includes all RSV+ infants independent of recruitment group as no differences in correlation between sample type were anticipated between recruitment group.|||Spearman R score|Number matched nasosorption and NPA||Number
2539848|NCT03062917|Primary|Accuracy of Nasosorption for Viral Load Measurement|To determine the difference in accuracy of nasosorption compared to NPA by assessment of level of viral load (measured by qPCR).|Throughout symptomatic respiratory infection, up to 1 month|Spearman R score correlation between RSV viral load as measured by nasosorption and NPA. This analysis includes all RSV+ infants independent of recruitment group as no differences in correlation between sample type were anticipated between recruitment group.|||Spearman R score|Number matched RSV+ nasosorption and NPA||Number
2540481|NCT03047174|Secondary|Number of Participants With Grade ≥2 Radiation Dermatitis at 60 Gy (Per Protocol Set)|Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.|at 60 Gy (about 6 weeks)|Per Protocol Set|||Participants|||Count of Participants
2539850|NCT03062605|Primary|Microbial Levels|The CRT® Bacteria (Ivoclar Vivadent) saliva sample test is done on culture media that is specific for S. mutans and Lactobacillus. After incubation for 3 days the colonies are compared to photographic standards.|Baseline, 12 weeks|Number analyzed includes participants retained in the study for whom CRT results were available|||Participants|||Count of Participants
2539851|NCT03062488|Secondary|Post Operative Fentanyl Consumption|Post operative administration of fentanyl in micrograms per Kilogram of weight after intra-operative pain management in the Post Anesthesia Care Unit (PACU)|first 60 minutes in the PACU||||microgram per Kg of weight||Standard Deviation|Mean
2539852|NCT03062488|Secondary|Post Operative Pain|Measured on scale of 0-10 0-3 = mild pain 4-6 = moderate pain 7-10 = severe pain Tools used for each age subgroup: FLACC Score for patients 24 months to 4 years of age and sedated patients at time of assessment, Wong-Baker FACES for patients between 4 and 7 years of age, and Numeric Pain Scores for patients equal/greater than 7 years of age|Average in first 60 minutes of recovery post anesthesia||||score on a scale||Standard Deviation|Mean
2539853|NCT03062488|Primary|Emergence Agitation (EA) as Measured by Standardized PAED Scale|Post Anesthesia Emergence Delirium (PAED) Scale 0 - 20. EA defined as a score equal or greater than 12|first 60 minutes of recovery post anesthesia||||score on a scale||Standard Deviation|Mean
2539854|NCT03062228|Secondary|Mode of Delivery|Mode of delivery (spontaneous vaginal, Cesarean section, instrumented) will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.|Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)|Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.|||Participants|||Count of Participants
2539855|NCT03062228|Secondary|Preterm Delivery|Preterm delivery is defined as gestational age at birth <37 weeks.|Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)|Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.|||Participants|||Count of Participants
2539856|NCT03062228|Secondary|Sex of Newborn|Sex of participant's newborn.|Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)|Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.|||Participants|||Count of Participants
2539857|NCT03062228|Secondary|Low Birth Weight|Low birth weight is defined has birth weight ≤ 2500 grams.|Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)|Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.|||Participants|||Count of Participants
2539858|NCT03062228|Secondary|Small for Gestational Age|Small for Gestational Age is defined as a birthweight centile ≤10th centile per the Gestation-Related Optimal Weight (GROW) standard.|Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)|Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.|||Participants|||Count of Participants
2539859|NCT03062228|Secondary|Gestational Age at Delivery|Gestational age at delivery (weeks) will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.|Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)|Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.|||Weeks||Standard Deviation|Mean
2539860|NCT03062228|Primary|Customized Birth Weight Centile|"Individual customized birth weight centile calculated using the Gestation Network (Perinatal Institute; Birmingham, UK) Bulk Centile Calculator (BCC), which calculates customized birthweight centiles using the principles of the Gestation Related Optimal Weight (GROW) method.~The main non-pathological factors affecting birth weight are gestational age, maternal height, maternal weight at booking, parity, and ethnic group. The sex of fetus/neonate, when known, should also be adjusted for. These six variables need to be adjusted for to calculate the true growth potential, which can be represented as individually customized fetal growth curves and birth weight percentiles using the principles of the GROW. This method for calculating growth potential has been validated in a number of international studies."|Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)|Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.|||percentile||Standard Deviation|Mean
2539861|NCT03062228|Primary|Birth Weight of Baby|At delivery, birth weight will be measured and recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.|Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)|Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital.|||grams||Standard Deviation|Mean
2539862|NCT03061513|Secondary|Cerebral Redox Markers|Change from baseline in lactate levels at 8 weeks as determined by Magnetic Resonance Spectroscopy|at baseline and 8 weeks||||Ratio||Standard Deviation|Mean
2539863|NCT03061513|Primary|Number of Adverse Events|The incidence and severity of adverse events in Parkinson disease patients taking 600mg ubiquinol or placebo daily over a 6 month period.|at 24 weeks|ITT|||Number of Adverse Events|||Number
2539864|NCT03061331|Primary|Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 8|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Study Baseline, Through Week 8|"Full Analysis set included as all randomized participants who had at least 1 A455E mutation and received at least 1 dose of study drug. Here Overall number of participants analyzed signifies those participants who were evaluable for this outcome."|||Percentage of predicted FEV1||95% Confidence Interval|Least Squares Mean
2539865|NCT03061279|Secondary|Amount Pain Medication Required During Recovery Period|Pain medication measured in morphine equivalents.|Up to 2 years|No analysis was conducted due to small sample size and confidentiality concerns.||||||
2539866|NCT03061279|Secondary|Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Physical Function|The PROMIS physical function score is based on an adaptive test, and reported as a cumulative T-score with standard error.|Baseline, year 2|No analysis was conducted due to small sample size and confidentiality concerns.||||||
2539867|NCT03061279|Secondary|Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Pain Interference|The PROMIS pain interference score is based on an adaptive test, and reported as a cumulative T-score with standard error.|Baseline, year 2|No analysis was conducted due to small sample size and confidentiality concerns.||||||
2539868|NCT03061279|Secondary|Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Depression|The PROMIS depression score is based on an adaptive test, and reported as a cumulative T-score with standard error.|Baseline, year 2|No analysis was conducted due to small sample size and confidentiality concerns.||||||
2539869|NCT03061279|Secondary|Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Lower Extremity Function Scale (LEFS)|The PROMIS LEFS scale consists of 20 questions, each on a 5-point Likert scale (0 = extreme difficulty, 4 = no difficulty). Questions are summed for a total score.|Baseline, year 2|No analysis was conducted due to small sample size and confidentiality concerns.||||||
2539870|NCT03061279|Secondary|Fracture Union Rate at One Year After Sustaining an Ankle Fracture.|Fracture union rate assessed by radiographic imaging.|Month 3|No analysis was conducted due to small sample size and confidentiality concerns.||||||
2539871|NCT03061279|Primary|Change in Severity of Hardware Related Pain Localized to the Medial Malleolus at One Year After Sustaining an Ankle Fracture.|Pain on a visual analogue scale (range: 0 to 1; 0 = no pain; 10 = worst pain imaginable).|Baseline, year 1|No analysis was conducted due to small sample size and confidentiality concerns.||||||
2539872|NCT03061214|Secondary|Occurence of Cross Reacting Antibodies With in Vitro Neutralising Effect to Endogenous GLP-1 (Yes/no)|This outcome measure is only applicable for the semaglutide arms. Development of cross reacting antibodies with in-vitro neutralising effect to endogenous glucagon-like peptide-1 (GLP-1) was evaluated in participants. The number of participants who were positive/ negative for anti-semaglutide antibodies with in vitro neutralising effect to endogenous GLP-1 are presented. Evaluation was based on in-trial observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.|Week 35|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Participants|||Count of Participants
2539873|NCT03061214|Secondary|Occurence of Anti-semaglutide Antibodies Cross Reacting With Endogenous GLP-1 (Yes/no)|This outcome measure is only applicable for the semaglutide arms. Development of anti-semaglutide antibodies cross reacting with endogenous glucagon-like peptide-1 (GLP-1) was evaluated in participants. The number of participants who were positive/ negative for anti-semaglutide antibodies cross reacting with endogenous GLP-1 are presented. Evaluation was based on in-trial observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.|Week 35|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Participants|||Count of Participants
2539874|NCT03061214|Secondary|Occurence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no)|This outcome measure is only applicable for the semaglutide arms. Development of anti-semaglutide antibodies with in-vitro neutralising effect was evaluated in participants during the study. The number of participants who were positive/ negative for anti-semaglutide antibodies with in vitro neutralising effect are presented. Evaluation was based on in-trial observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.|Week 0, week 16, week 30, week 35|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Participants|||Count of Participants
2539875|NCT03061214|Secondary|Occurence of Anti-semaglutide Antibodies (Yes/no)|This outcome measure is only applicable for the semaglutide arms. Development of anti-semaglutide antibodies was evaluated in participants during the study. The number of participants who were positive/ negative for anti-semaglutide antibodies were presented. Evaluation was based on 'in trial' observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.|Week 0, week 16, week 30, week 35|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Participants|||Count of Participants
2539876|NCT03061214|Secondary|Anti-semaglutide Antibody Levels|This outcome measure is only applicable for the semaglutide arms. Anti-semaglutide antibody level at week 30 and week 35 are presented. Antibody levels were measured in percentage of bound radioactivity-labelled semaglutide/total added radioactivity-labelled semaglutide (%B/T; B =Bound, T = Total). Evaluation was based on 'in trial' observation period, which is the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.|week 30, week 35|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed=participants with available data."|||%B/T||Standard Deviation|Mean
2539877|NCT03061214|Secondary|Change in Physical Examination|Physical examination parameters are categorised as general appearance; nervous system (central and peripheral); cardiovascular system; gastrointestinal system; skin; respiratory system; lymph node palpation; thyroid gland; left foot; right foot; left leg and right leg. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -2) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week -2, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Number Analyzed = participants with available data."|||Participants|||Count of Participants
2539916|NCT03061214|Secondary|Total Number of Treatment Emergent Adverse Events|A treatment emergent adverse event (TEAE) is defined as an adverse event with onset in the on-treatment observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0 to week 30|Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product.|||Events|||Number
2539878|NCT03061214|Secondary|Change in Clinical Evaluation: Eye Examinations|Eye examination was performed by the investigator and the results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Number of participants in each category at baseline (week 0) and at week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Number Analyzed = participants with available data."|||Participants|||Count of Participants
2539879|NCT03061214|Secondary|Change in Clinical Evaluation: ECG|The electrocardiogram (ECG) was assessed by the investigator and categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Number of participants in each ECG category at baseline and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Number Analyzed = participants with available data."|||Participants|||Count of Participants
2539880|NCT03061214|Secondary|Change in Clinical Evaluation: Pulse|Change in pulse from baseline (week 0) to week 30 is presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed=participants with available data."|||Beats per minute (beats/min)||Standard Deviation|Mean
2539881|NCT03061214|Secondary|Change in Urinalysis Parameter: Erythrocytes|Erythrocytes in urine was assessed by the investigator and categorised as negative, trace, small, moderate, large. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Participants|||Count of Participants
2539882|NCT03061214|Secondary|Change in Urinalysis Parameter: Ketones|Ketones in urine was assessed by the investigator and categorised as negative, trace, 15-39, 40-79, Approximately 80, >= 80. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Participants|||Count of Participants
2539883|NCT03061214|Secondary|Change in Urinalysis Parameter: Protein|Protein in urine was assessed by the investigator and categorised as negative, trace, 30-99, 100-299, Approximately 300, >=300. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Participants|||Count of Participants
2539884|NCT03061214|Secondary|Change in Urinalysis Parameter: pH|pH in urine was assessed by the investigator and categorised as 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, >=9. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Participants|||Count of Participants
2539885|NCT03061214|Secondary|Change in Urinalysis Parameter: Glucose|Glucose in urine was assessed by the investigator and categorised as negative, [100-249], [250-499], [500-999] and >= 1000. Number of participants in each category at baseline (week 0) and week 30 are presented. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Participants|||Count of Participants
2539886|NCT03061214|Secondary|Change in Urinalysis Parameter - UACR-ratio to Baseline|Change in urin albumin to creatinine ratio (UACR) from baseline (week 0) to week 30 is presented as ratio to baseline. UACR was measured in milligram/millimole (mg/mmol). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed=participants with available data."|||Ratio of UACR||Geometric Coefficient of Variation|Geometric Mean
2539887|NCT03061214|Secondary|Change in Calcitonin - Ratio to Baseline|Change in calcitonin from baseline (week -2) to week 30 is presented as ratio to baseline. Calcitonin was measured in nanogram per liter (ng/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week -2, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of calcitonin||Geometric Coefficient of Variation|Geometric Mean
2539888|NCT03061214|Secondary|Change in Biochemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) - Ratio to Baseline|Change in estimated glomerular filtration rate (eGFR) from baseline (week 0) to week 30 is presented as ratio to baseline. Glomerular filtration rate was measured in milliliter/minute/specific surface area (mL/min/SSA). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of eGFR||Geometric Coefficient of Variation|Geometric Mean
2539889|NCT03061214|Secondary|Change in Biochemistry Parameter: Urea - Ratio to Baseline|Change in urea from baseline (week 0) to week 30 is presented as ratio to baseline. Urea was measured in millimoles per liter (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of urea||Geometric Coefficient of Variation|Geometric Mean
2539890|NCT03061214|Secondary|Change in Biochemistry Parameter: Creatinine - Ratio to Baseline|Change in creatinine from baseline (week -2) to week 30 is presented as ratio to baseline. Creatinine was measured in micromoles per lier (umol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week -2, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of creatinine||Geometric Coefficient of Variation|Geometric Mean
2539891|NCT03061214|Secondary|Change in Biochemistry Parameter: Total Protein- Ratio to Baseline|Change in Total protein from baseline (week 0) to week 30 is presented as ratio to baseline. Total Protein was measured in grams per deciliter (g/dL). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of total protein||Geometric Coefficient of Variation|Geometric Mean
2539892|NCT03061214|Secondary|Change in Biochemistry Parameter: Creatine Kinase - Ratio to Baseline|Change in creatine kinase from baseline (week 0) to week 30 is presented as ratio to baseline. Creatine kinase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of creatine kinase||Geometric Coefficient of Variation|Geometric Mean
2539893|NCT03061214|Secondary|Change in Biochemistry Parameter: Albumin - Ratio to Baseline|Change in albumin from baseline (week 0) to week 30 is presented as ratio to baseline. Albumin was measured in grams per deciliter (g/dL). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of albumin||Geometric Coefficient of Variation|Geometric Mean
2539894|NCT03061214|Secondary|Change in Biochemistry Parameter: Sodium - Ratio to Baseline|Change in sodium from baseline (week 0) to week 30 is presented as ratio to baseline. Sodium was measured in millimoles per litre (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of sodium||Geometric Coefficient of Variation|Geometric Mean
2539895|NCT03061214|Secondary|Change in Biochemistry Parameter: Potassium - Ratio to Baseline|Change in potassium from baseline (week 0) to week 30 is presented as ratio to baseline. Potassium was measured in millimoles per liter (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of potassium||Geometric Coefficient of Variation|Geometric Mean
2539896|NCT03061214|Secondary|Change in Biochemistry Parameter: Total Calcium - Ratio to Baseline|Change in total calcium from baseline (week 0) to week 30 is presented as ratio to baseline. Calcium was measured in millimoles per litre (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of total calcium||Geometric Coefficient of Variation|Geometric Mean
2539897|NCT03061214|Secondary|Change in Biochemistry Parameter: Calcium (Corrected)- Ratio to Baseline|Change in calcium (corrected) from baseline (week 0) to week 30 is presented as ratio to baseline. Calcium was measured in millimoles per litre (mmol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of calcium||Geometric Coefficient of Variation|Geometric Mean
2539898|NCT03061214|Secondary|Change in Biochemistry Parameter: Total Bilirubin - Ratio to Baseline|Change in total bilirubin from baseline (week 0) to week 30 is presented as ratio to baseline. Total bilirubin was measured in micromoles per liter (umol/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of total bilirubin||Geometric Coefficient of Variation|Geometric Mean
2539899|NCT03061214|Secondary|Change in Biochemistry Parameter: Aspartate Aminotransferase - Ratio to Baseline|Change in aspartate aminotransferase from baseline (week 0) to week 30 is presented as ratio to baseline. Aspartate aminotransferase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of aspartate aminotransferase||Geometric Coefficient of Variation|Geometric Mean
2539900|NCT03061214|Secondary|Change in Biochemistry Parameter: Alanine Aminotransferase - Ratio to Baseline|Change in alanine aminotransferase from baseline (week 0) to week 30 is presented as ratio to baseline. Alanine aminotransferase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of alanine aminotransferase||Geometric Coefficient of Variation|Geometric Mean
2539901|NCT03061214|Secondary|Change in Biochemistry Parameter: Alkaline Phosphatase - Ratio to Baseline|Change in alkaline phosphatase from baseline (week 0) to week 30 is presented as ratio to baseline. Alkaline phosphatase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of alkaline phosphatase||Geometric Coefficient of Variation|Geometric Mean
2539902|NCT03061214|Secondary|Change in Biochemistry Parameter: Lipase - Ratio to Baseline|Change in lipase from baseline (week 0) to week 30 is presented as ratio to baseline. Lipase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of lipase||Geometric Coefficient of Variation|Geometric Mean
2539903|NCT03061214|Secondary|Change in Biochemistry Parameter: Amylase - Ratio to Baseline|Change in amylase from baseline (week 0) to week 30 is presented as ratio to baseline. Amylase was measured in units per liter (U/L). Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of amylase||Geometric Coefficient of Variation|Geometric Mean
2539904|NCT03061214|Secondary|Change in Hematological Parameter (Differential Cell Count of Leukocytes): Lymphocytes - Ratio to Baseline|Change in lymphocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Lymphocytes were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of lymphocytes||Geometric Coefficient of Variation|Geometric Mean
2539905|NCT03061214|Secondary|Change in Hematological Parameter (Differential Cell Count of Leukocytes): Monocytes - Ratio to Baseline|Change in monocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Monocytes were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of monocytes||Geometric Coefficient of Variation|Geometric Mean
2539906|NCT03061214|Secondary|Change in Hematological Parameter (Differential Cell Count of Leukocytes): Eosinophils - Ratio to Baseline|Change in eosinophils from baseline (week 0) to week 30 is presented as ratio to baseline. Eosinophils were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of eosinophils||Geometric Coefficient of Variation|Geometric Mean
2539917|NCT03061214|Secondary|Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥10%|Percentage of participants losing ≥10% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Percentage of participants|||Number
2539907|NCT03061214|Secondary|Change in Hematological Parameter (Differential Cell Count of Leukocytes): Neutrophils - Ratio to Baseline|Change in neutrophils from baseline (week 0) to week 30 is presented as ratio to baseline. Neutrophils were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of neutrophils||Geometric Coefficient of Variation|Geometric Mean
2539908|NCT03061214|Secondary|Change in Hematological Parameter (Differential Cell Count of Leukocytes): Basophils - Ratio to Baseline|Change in basophils from baseline (week 0) to week 30 is presented as ratio to baseline. Basophils were measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of basophils||Geometric Coefficient of Variation|Geometric Mean
2539909|NCT03061214|Secondary|Change in Hematological Parameter: Leukocytes - Ratio to Baseline|Change in leukocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Leukocytes were measured in 10^9 cells per liter. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of leukocytes||Geometric Coefficient of Variation|Geometric Mean
2539910|NCT03061214|Secondary|Change in Hematological Parameter: Erythrocytes - Ratio to Baseline|Change in erythrocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Erythrocytes were measured in 10^12 cells per liter. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of erythrocytes||Geometric Coefficient of Variation|Geometric Mean
2539911|NCT03061214|Secondary|Change in Hematological Parameter: Thrombocytes - Ratio to Baseline|Change in thrombocytes from baseline (week 0) to week 30 is presented as ratio to baseline. Thrombocytes was measured in 10^9 cells per liter. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of thrombocytes||Geometric Coefficient of Variation|Geometric Mean
2539912|NCT03061214|Secondary|Change in Haematological Parameter: Haematocrit - Ratio to Baseline|Change in haematocrit from baseline (week 0) to week 30 is presented as ratio to baseline. Haematocrit was measured in percentage. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of haematocrit||Geometric Coefficient of Variation|Geometric Mean
2539913|NCT03061214|Secondary|Change in Haematological Parameter: Haemoglobin - Ratio to Baseline|Change in haemoglobin from baseline (week 0) to week 30 is presented as ratio to baseline. Haemoglobin was measured in mmol/L. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 30|"Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data."|||Ratio of haemoglobin||Geometric Coefficient of Variation|Geometric Mean
2539914|NCT03061214|Secondary|Participants With Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes|Number of participants with treatment emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes. Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0 to week 30|Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product.|||Participants|||Count of Participants
2539915|NCT03061214|Secondary|Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes|Hypoglycaemic episodes are defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the 'on-treatment' observation period. On-treatment observation period is defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0 to week 30|Safety analysis set comprised of all randomised participants exposed to at least one dose of trial product.|||Episodes|||Number
2540204|NCT03054844|Secondary|Procedural Distress, FLACC|The Faces, Legs, Activity, Cry, Consolability (FLACC) scale is comprised of five criteria (face, legs, activity, cry, consolability), with a possible score of 0 to 2 units on a scale for each criteria and a possible total score of 0 to 10 units on a scale (0 meaning no pain, 10 meaning most pain).|10 minutes||||Units on a scale||95% Confidence Interval|Mean
2539918|NCT03061214|Secondary|Percentage of Participants That Achieved (Yes/no): Body Weight Loss ≥5%|Percentage of participants losing ≥5% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Percentage of participants|||Number
2539919|NCT03061214|Secondary|Percentage of Participants That Achieved (Yes/no): HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemia and no Weight Gain|Severe or blood glucose (BG)-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 milligrams per deciliter [mg/dL]) with symptoms consistent with hypoglycaemia. Percentage of participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Percentage of participants|||Number
2539920|NCT03061214|Secondary|Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/Mol), AACE Target, (Yes/no)|Percentage of participants who achieved HbA1c ≤6.5% (48 millimoles per mole [mmol/mol]), American Association of Clinical Endocrinologists (AACE) target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Percentage of participants|||Number
2539921|NCT03061214|Secondary|Percentage of Participants Who Achieved HbA1c <7.0% (53 mmol/Mol), ADA Target, (Yes/no)|Percentage of participants who achieved HbA1c < 7.0% (53 millimoles per mole [mmol/mol]), American Diabetes Association (ADA) target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Percentage of participants|||Number
2539922|NCT03061214|Secondary|Change in Blood Pressure (Systolic and Diastolic Blood Pressure)|Change from baseline (week 0) to week 30 in systolic blood pressure and diastolic blood pressure were evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2539923|NCT03061214|Secondary|Change in Free Fatty Acids - Ratio to Baseline|Change in free fatty acids from baseline (week 0) to week 30 is presented as ratio to baseline. Free fatty acids was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed=participants with available data."|||Ratio of free fatty acids||Geometric Coefficient of Variation|Geometric Mean
2539924|NCT03061214|Secondary|Change in Fasting Triglycerides - Ratio to Baseline|Change in fasting triglycerides from baseline (week 0) to week 30 is presented as ratio to baseline. Triglycerides was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Ratio of fasting triglycerides||Geometric Coefficient of Variation|Geometric Mean
2539925|NCT03061214|Secondary|Change in Fasting HDL Cholesterol - Ratio to Baseline|Change in fasting high density lipoprotein (HDL) from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting HDL was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Ratio of fasting HDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2539926|NCT03061214|Secondary|Change in Fasting VLDL Cholesterol - Ratio to Baseline|Change in fasting very low density lipoprotein (VLDL) from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting VLDL was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Ratio of fasting VLDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2539927|NCT03061214|Secondary|Change in Fasting LDL Cholesterol - Ratio to Baseline|Change in fasting low density lipoprotein (LDL) from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting LDL was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Ratio of fasting LDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2540482|NCT03047174|Primary|Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Per Protocol Set)|Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.|at 50 Gy (about 5 weeks)|Per Protocol Set|||Participants|||Count of Participants
2539928|NCT03061214|Secondary|Change in Fasting Total Cholesterol - Ratio to Baseline|Change in fasting total cholesterol from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting total cholesterol was measured in mmol/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Ratio of fasting total cholesterol||Geometric Coefficient of Variation|Geometric Mean
2539929|NCT03061214|Secondary|Change in BMI|Change in body mass index (BMI) from baseline (week 0) to week 30 was measured. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Kilogram per square meter (kg/m^2)||Standard Deviation|Mean
2539930|NCT03061214|Secondary|Change in Waist Circumference|Change in waist circumference from baseline (week 0) to week 30 was measured. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Centimeter (cm)||Standard Deviation|Mean
2539931|NCT03061214|Secondary|Change in High-sensitivity CRP - Ratio to Baseline|Change in high-sensitivity C-reactive protein (CRP) from baseline (week 0) to week 30 is presented as ratio to baseline. High-sensitivity CRP was measured in mg/L. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed=participants with available data."|||Ratio of high-sensitivity CRP||Geometric Coefficient of Variation|Geometric Mean
2539932|NCT03061214|Secondary|Change in Patient Reported Outcome Questionnaire: DTSQs Score|"Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire (DTSQs) was evaluated at week 30. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 3 -8. For items 1 and 2 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 1) or low (item 2). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 3-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the 'on-treatment without rescue medication' observation period."|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Score on a scale||Standard Deviation|Mean
2539933|NCT03061214|Secondary|Change in Patient Reported Outcome Questionnaire: SF-36v2™ Score|Short Form (SF)-36 is a 36-item patient-reported survey that measures patient's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured 8 domains of functional health & well-being and 2 component summary scores (physical component summary-PCS and mental component summary-MCS). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 30. A positive change score indicates an improvement since baseline. Results are based on the data from the 'on-treatment without rescue medication' observation period.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Score on a scale||Standard Deviation|Mean
2539934|NCT03061214|Secondary|Change in Fasting HOMA-IR (Insulin Resistence) - Ratio to Baseline|Change in fasting HOMA-IR (homeostasis model assessment insulin resistence) from baseline (week 0) to week 30 is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed=participants with available data."|||Ratio of fasting HOMA-IR||Geometric Coefficient of Variation|Geometric Mean
2539935|NCT03061214|Secondary|Change in Fasting HOMA-B (Beta-cell Function) - Ratio to Baseline|Change in fasting HOMA-B (homeostasis model assessment beta-cell function) from baseline (week 0) to week 30 is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed=participants with available data."|||Ratio of fasting HOMA-B||Geometric Coefficient of Variation|Geometric Mean
2539936|NCT03061214|Secondary|Change in Fasting Proinsulin/Insulin Ratio - Ratio to Baseline|Change in fasting proinsulin/insulin ratio from baseline (week 0) to week 30 is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Ratio of fasting proinsulin/insulin||Geometric Coefficient of Variation|Geometric Mean
2540020|NCT03057704|Secondary|Investigators Rating of Patient Discomfort|"Investigator rates patient's nonverbal display of discomfort.~Investigator Assessments:~Induction Discomfort Scale (during injection and within 5 seconds after injection)~No change in patient behavior (0)~Grimace (1)~IV forearm withdrawal (2)~Moaning (3)~Verbal statement of discomfort (it hurts, etc.) (4) 0 indicates desired outcome of no pain and 4 indicates worst IV pain experienced."|During injection at beginning of study period; lasts 10 seconds one time only||||units on a scale||Standard Deviation|Mean
2539937|NCT03061214|Secondary|Change in Fasting Proinsulin - Ratio to Baseline|Change in fasting proinsulin from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting proinsulin was measured in picomole per liter (pmol/L). Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed=participants with available data."|||Ratio of fasting proinsulin||Geometric Coefficient of Variation|Geometric Mean
2539938|NCT03061214|Secondary|Change in Fasting Glucagon - Ratio to Baseline|Change in fasting glucagon from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting glucagon was measured in picogram per mililiter (pg/mL). Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed=participants with available data."|||Ratio of fasting glucagon||Geometric Coefficient of Variation|Geometric Mean
2539939|NCT03061214|Secondary|Change in Fasting C-peptide - Ratio to Baseline|Change in fasting C-peptide from baseline (week 0) to week 30 is presented as ratio to baseline. C-peptide was measured in nanomoles per liter (nmol/L). Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed=participants with available data."|||Ratio of fasting C-peptide||Geometric Coefficient of Variation|Geometric Mean
2539940|NCT03061214|Secondary|Change in Fasting Insulin - Ratio to Baseline|Change in fasting insulin from baseline (week 0) to week 30 is presented as ratio to baseline. Fasting insulin was measured in picomoles per liter (pmol/L). Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Ratio of fasting insulin||Geometric Coefficient of Variation|Geometric Mean
2539941|NCT03061214|Secondary|Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals|Change from baseline (week 0) to week 30 in SMPG mean postprandial increment over all meals was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2539942|NCT03061214|Secondary|Change in Self-measured Plasma Glucose (SMPG) - Mean 7-point Profile|Change from baseline (week 0) to week 30 in SMPG mean 7-point profile was evaluated. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the 'on-treatment without rescue medication' observation period which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2539943|NCT03061214|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline (week 0) to week 30 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed=participants with available data."|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2539944|NCT03061214|Secondary|Change in Body Weight|Change from baseline (week 0) to week 30 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first.|Week 0, week 30|"Full analysis set comprised of all randomised participants. Overall Number of Participants Analyzed = participants with available data."|||Kilogram (kg)||Standard Deviation|Mean
2539945|NCT03061214|Primary|Change in HbA1c|Change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period and 'in trial' observation period. 'On-treatment without rescue medication' observation period: started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. 'In-trial' observation period: started when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.|Week 0, week 30|"Full analysis set comprised of all randomised participants.Number Analyzed = participants with available data."|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
2539946|NCT03060512|Secondary|Mean Change From Baseline at Visit 3/5 in Bowel Function Index (BFI) Questionnaire Scores to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms|"The BFI is a 3-item questionnaire administered by a study clinician to measure constipation from the subject's perspective (ease of defecation, feeling of complete evacuation, and personal judgment of constipation). For each item the subject was asked to rate their response on a scale from 0 to 100, where 0 indicates the best response (easy/no diffculty) and 100 the worst response (severe difficulty). The total BFI score was calculated as the mean of the 3 item scores.~The mean change from baseline in BFI scores at Visits 3 and/or 5 are presented."|From Baseline (Visit 2, Day 1) to Visit 3 (Day 15) and Visit 5 (Day 36).|The FAS consisted of all subjects who satisfied inclusion and exclusion criteria, received study medication, and attended at least one scheduled visit. Data is presented for subjects with non-missing BFI data at the end of at least one of the two week treatment periods.|||Score||Standard Deviation|Mean
2539947|NCT03060512|Secondary|PGIC Questionnaire Individual Item Results to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms|"PGIC was measured on a 7-point scale at the end of each two-week treatment period to assess the subject's impression of the effectiveness of the treatment received for OIC. The subjects selected one of the following PGIC items as their response: 1 = No change (or condition has gotten worse); 2 = Almost the same, hardly any change at all; 3 = A little better, but no noticeable change; 4 = Somewhat better, but the change has not made any real differences; 5 = Moderately better, and a slight but noticeable change; 6 = Better and a definite improvement that has made a real and worthwhile difference; and 7 = A great deal better and a considerable improvement that has made all the difference. The score range is from 1 to 7, with 1 indicating the least improvement and 7 indicating the greatest improvement in OIC symptoms.~The number of subjects responding to each PGIC item at Visits 3 and/or 5 is presented for each treatment overall."|At Visit 3 (Day 15) of Treatment Period 1 and Visit 5 (Day 36) of Treatment Period 2.|The FAS consisted of all subjects who satisfied inclusion and exclusion criteria, received study medication, and attended at least one scheduled visit. Data is presented for subjects with non-missing PGIC data at the end of at least one of the treatment periods.|||Participants|||Number
2539948|NCT03060512|Secondary|Patient Global Impression of Change (PGIC) Questionnaire to Compare the Impact of Movantik and PEG 3350 on OIC Symptoms|"PGIC was measured on a 7-point scale at the end of each two-week treatment period to assess the subject's impression of the effectiveness of the treatment received for OIC. The scoring was as follows: 1 = No change (or condition has gotten worse); 2 = Almost the same, hardly any change at all; 3 = A little better, but no noticeable change; 4 = Somewhat better, but the change has not made any real difference; 5 = Moderately better, and a slight but noticeable change; 6 = Better and a definite improvement that has made a real and worthwhile difference; and 7 = A great deal better and a considerable improvement that has made all the difference. The score range is from 1 to 7, with 1 indicating the least improvement and 7 indicating the greatest improvement in OIC symptoms.~Mean score results are presented for each treatment for Visits 3 and 5."|At Visit 3 (Day 15) of Treatment Period 1 and Visit 5 (Day 36) of Treatment Period 2.|The FAS consisted of all subjects who satisfied inclusion and exclusion criteria, received study medication, and attended at least one scheduled visit. Data is presented for subjects with non-missing PGIC data at the end of at least one of the treatment periods.|||Score||Standard Deviation|Mean
2539949|NCT03060512|Secondary|Patient Reported Influence of Each Medication Characteristic Individual Category Results That Contributed to Their Overall Preference for Movantik or PEG 3350|"In order to assess the reason for patient preference of Movantik or PEG 3350, subjects reported on the influence of 5 medication characteristics using a 4-point rating scale. The following were the scale options: efficacy ('worked better to relieve my OIC'), tolerability ('tolerated better'), convenience ('was more convenient'), works quickly ('worked quickly') and works predictably ('worked predictably'). For each characteristic, influence scores were rated as: 0 = No influence, 1 = Mildly influenced, 2 = Moderately influenced or 3 = Strongly influenced. The scale range for each characteristic was from 0 to 3, and the number of subjects in each characteristic category is presented for the overall PP Set according to which treatment was preferred.~The assessment was only completed by subjects who indicated an overall preference."|From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).|The PP Set consisted of the subset of the FAS subjects who completed the Patient Preference Assessment at Visit 5 (end of study), and who completed the treatment sequence in the order as specified by the randomised treatment sequence, and were not excluded due to an important protocol deviation.|||Participants|||Count of Participants
2539950|NCT03060512|Secondary|Patient Reported Influence of Each Medication Characteristic Median Scores That Contributed to Their Overall Preference for Movantik or PEG 3350|"In order to assess the reason for patient preference of Movantik or PEG 3350, subjects reported on the influence of 5 medication characteristics using a 4-point rating scale. The following were the scale options: efficacy ('worked better to relieve my OIC'), tolerability ('tolerated better'), convenience ('was more convenient'), works quickly ('worked quickly') and works predictably ('worked predictably'). For each characteristic, influence scores were rated as: 0 = No influence, 1 = Mildly influenced, 2 = Moderately influenced or 3 = Strongly influenced. The scale range for each characteristic was from 0 to 3, and the median score for each characteristic is presented for the overall PP Set according to which treatment was preferred.~The assessment was only completed by subjects who indicated an overall preference."|From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).|The PP Set consisted of the subset of the FAS subjects who completed the Patient Preference Assessment at Visit 5 (end of study), and who completed the treatment sequence in the order as specified by the randomised treatment sequence, and were not excluded due to an important protocol deviation.|||Score||Full Range|Median
2539951|NCT03060512|Primary|Patient Reported Preference for Movantik or PEG 3350 for OIC Treatment by Treatment Sequence|The Patient Preference Assessment was conducted at Visit 5 using a 7-point scale in subjects with chronic non-cancer pain. The following categories were the possible responses: Strong preference for Movantik, Moderate preference for Movantik, Slight preference for Movantik, No preference, Slight preference for PEG 3350, Moderate preference for PEG 3350 and Strong preference for PEG 3350. Prefer Movantik included subjects in the categories Strong preference for Movantik, Moderate preference for Movantik and Slight preference for Movantik. Prefer PEG 3350 included subjects in the categories Strong preference for PEG 3350, Moderate preference for PEG 3350 and Slight preference for PEG 3350. Preference for Period 1 treatment and Preference for Period 2 treatment included subjects who preferred the first and second treatments respectively taken within a given treatment sequence. The number of subjects in each category is presented per treatment sequence for subjects in the PP Set.|From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).|The PP Set consisted of the subset of the FAS subjects who completed the Patient Preference Assessment at Visit 5 (end of study), and who completed the treatment sequence in the order as specified by the randomised treatment sequence, and were not excluded due to an important important protocol deviation.|||Participants|||Count of Participants
2540033|NCT03057366|Primary|Part A: Tmax: Time to Reach the Maximum Plasma and Whole Blood TRA Concentration (Cmax) for [14C]-Pevonedistat Drug-related Material||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK evaluable population included all enrolled participants who received the protocol-specified single [14C]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.|||hour||Full Range|Median
2539952|NCT03060512|Primary|Patient Reported Preference for Movantik or PEG 3350 for Opioid-induced Constipation (OIC) Treatment|The Patient Preference Assessment was conducted at Visit 5 using a 7-point scale in subjects with chronic non-cancer pain. The 3 categories were formed by collapsing the 7-point rating scale to: 1. Prefer Movantik (including Strong preference for Movantik, Moderate preference for Movantik, Slight preference for Movantik), 2. No preference, and 3. Prefer PEG 3350 (including Strong preference for PEG 3350, Moderate preference for PEG 3350, and Slight preference for PEG 3350). The number of subjects in each category is presented for the total number of subjects in the Per-Protocol (PP) Set.|From Visit 2 (Day 1) of Treatment Period 1 to Visit 5 (Day 36) of Treatment Period 2 (end of study).|The PP Set consisted of the subset of the FAS subjects who completed the Patient Preference Assessment at Visit 5 (end of study), and who completed the treatment sequence in the order as specified by the randomised treatment sequence, and were not excluded due to an important protocol deviation.|||Participants|||Count of Participants
2539953|NCT03060486|Primary|Change From Baseline in Root Canal Bleeding Score|"After the root canal, shaping was performed, and a first sterile paper point was introduced in the root canal, up to the working length, to detect blood presence.~The root canal bleeding score (RCBS) was given as follows:~0: no blood detected~1: blood detected in the apical third of the root canal~2: blood detected both in the apical and the middle thirds of the root canal~3: blood detected in the whole root canal. After the use of the material a second sterile paper point was introduced in the root canal, up to the working length, to detect the presence of blood and an RCBS was assessed according the previous criteria"|20 sec - before and after use||||score on a scale|teeth|Standard Deviation|Mean
2539954|NCT03059901|Primary|System Usability Questionnaire|"Participant perspective of program feasibility. Ten likert-type questions assessing user-friendliness of technology. Each question has five answer options that range from Strongly Agree to Strongly Disagree. Scores range from 0-100. A score of 68 or above is considered above average. All scores averaged."|4 weeks|Although 60 women were enrolled, 6 women did not utilize the app during the trial. These 6 women (2 from More App Notifications and 4 from Normal App Notifications) were not included in the data analysis because they did not have data to analyze.|||units on a scale||Standard Deviation|Mean
2539955|NCT03059810|Primary|Overall Vision|Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|12-16 Day Follow-up|Subjects that completed all visits without a major protocol deviation documented as impacted the assessment of the primary endpoint.|||Units on a Scale||Standard Deviation|Mean
2539956|NCT03058991|Primary|Specific Aim 4: Actual Smoking Status|The piCO Smokerlyzer is a tool used to assess amount of carbon monoxide exhaled by a participant, with scores ranging from 0 to 150 parts per million (PPM), with scores under 3 indicating non-smoking and scores over 36 indicating very heavy addiction. The Timeline Follow Back is a self-report measure in which participants report the amount of cigarettes smoked each day for the last month. Mean proportions of smokers are reported (0=no smoking, 1=smoking) with smoking behaviors assessed via the piCO Smokerlyzer and the Timeline Follow Back.|1 Week|Statistics are based on all cases with valid data for all variables in the model.|||Proportion of Smokers||Standard Deviation|Mean
2539957|NCT03058991|Primary|Specific Aim 3: Smoking Risk (Delay Discounting Task)|The Delay Discounting task is one of 3 assessments of smoking risk along with the B-IAT and SSA. It includes a series of computerized decisions in which participants select a money award immediately or a larger award in 7, 14, or 30 days time. Participants were notified that they would be paid the amount selected on one randomly selected trial. K-values were submitted for analyses with higher scores representing great discounting of delayed rewards, meaning that higher scores reflect greater tendency to select the immediate award. Natural logs of K-values were used if K-values showed a large amount of skew. Reported here are the natural logs of k-values from the delay discounting task. Natural logs are used to reduce skew of k-values.|1 Week|Statistics are based on all cases with valid data for all variables in the model.|||natural log of k-values||Standard Deviation|Mean
2539958|NCT03058991|Primary|Specific Aim 3: Smoking Risk (B-IAT)|"The brief Implicit Attitudes Test is one of 3 assessments of smoking risk along with the Delay Discounting task and the SSA. Reported here are the d-scores from the B-IAT task. Participants sorted stimuli into positive or negative categories in 4 blocks--2 of which included Smoking and I feel positive, the other 2 including Smoking and I feel negative. Shorter response times when sorting Smoking--Positive versus Smoking--Negative blocks indicate implicit tendency to associate smoking with positive. Standardized difference scores (d-scores) were computed using the improved scoring algorithm recommended by prior research (Greenwald, Banaji, & Nosek, 2003). Higher d-scores indicate less positive implicit attitudes towards smoking."|1 Week|Statistics are based on all cases with valid data for all variables in the model.|||Standardized Difference Scores||Standard Deviation|Mean
2539959|NCT03058991|Primary|Specific Aim 3: Smoking Risk (Standard Smoking Assessment)|The Standard Smoking Assessment is one of 3 assessments of smoking risk along with the B-IAT and the Delay Discounting task. Reported here are the results from the SSA, a 5-item scale asking about attitudes and likelihood of smoking with total scores ranging from 0 (no susceptibility) to 11 (highest susceptibility). The natural log of these scores are reported, with higher scores indicating higher susceptibility.|1 Week|Statistics are based on all cases with valid data for all variables in the model.|||natural log of units on a scale||Standard Deviation|Mean
2539960|NCT03058991|Primary|Specific Aim 2: Distress Tolerance|Distress Tolerance (DT) assessment includes the Distress Intolerance Index (DII) and the computerized Mirror-Tracing Persistence Task (MTPT-C) which are z-scored and aggregated to form a single DT index.The Distress Tolerance Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched children). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population and with higher scores reflecting worse tolerance.|1 Week|Statistics are based on all cases with valid data for all variables in the model.|||z-score||Standard Deviation|Mean
2551296|NCT02819804|Other Pre-specified|Progression Free Survival (PFS)|PFS is defined as the time from the initiation of study treatment until the time of disease progression or relapse.|Up to 1 year|||||||
2539961|NCT03058991|Primary|Specific Aim 2: Working Memory Capacity|Assessment includes three computer-administered WM performance measures (N-back, Auditory Digit Span, and Corsi Block Tapping task) which are z-scored and aggregated to create a single WM index.The Working Memory Capacity Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched children). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population and higher scores reflecting greater capacity.|1 Week||||z-score||Standard Deviation|Mean
2539962|NCT03058991|Primary|Specific Aim 1: Percentage of Participants Who Attended 13 or More Interventions|Feasibility/acceptability of each intervention (indexed by attendance of at least 80% of interventions by 70% of the randomized sample) will be assessed.|Intervention (week 1 to week 8)|Percentage of individuals who attended at least 80% of interventions reported.|||percentage of participants|||Number
2539963|NCT03058705|Primary|Minimal Dwell Time|The minimum time needed to observe the tumors during transurethral resection of bladder tumor (TURBT).|Day 1|Dwell time was not collected on any participant due to failure to visual fluorescence in the subjects.||||||
2539964|NCT03058692|Secondary|The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200|Blood was collected from participants for testing in the neutralizing antibody assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.|Day 200|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of participants||95% Confidence Interval|Number
2539965|NCT03058692|Secondary|The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172|Blood was collected from participants for testing in the neutralizing antibody assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.|Day 172|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of participants||95% Confidence Interval|Number
2539966|NCT03058692|Secondary|The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43|Blood was collected from participants for testing in the neutralizing antibody assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.|Day 43|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of participants||95% Confidence Interval|Number
2539967|NCT03058692|Secondary|The Percentage of Participants With a Neutralizing Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1|Blood was collected from participants for testing in the neutralizing antibody assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.|Day 1|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of participants||95% Confidence Interval|Number
2539968|NCT03058692|Secondary|The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 200|Blood was collected from participants for testing in the HAI assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.|Day 200|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of participants||95% Confidence Interval|Number
2539969|NCT03058692|Secondary|The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 172|Blood was collected from participants for testing in the HAI assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.|Day 172|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of participants||95% Confidence Interval|Number
2539970|NCT03058692|Secondary|The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 43|Blood was collected from participants for testing in the HAI assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.|Day 43|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of participants||95% Confidence Interval|Number
2540034|NCT03057366|Primary|Part A: Cmax: Maximum Observed Plasma and Whole Blood TRA Concentration for [14C]-Pevonedistat Drug-related Material||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK evaluable population included all enrolled participants who received the protocol-specified single [14C]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.|||nanogram equivalent per milliliter||Standard Deviation|Mean
2539971|NCT03058692|Secondary|The Percentage of Participants With an HAI Antibody Titer of 40 or Greater and GMTs vs. IIV4 Vaccine Viruses at Day 1|Blood was collected from participants for testing in the HAI assay with the vaccine viruses as the assay antigens. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 40 or greater.|Day 1|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of participants||95% Confidence Interval|Number
2539972|NCT03058692|Secondary|The Percentage of Subjects Achieving Neutralizing Antibody Seroconversion to IIV4 Vaccine Virus at Day 200|Blood was collected from participants for testing in the neutralizing antibody assay with the vaccine viruses as the assay antigens. Seroconversion was defined as a pre-vaccination titer less than 10 and post-vaccination titer greater than or equal to 40, or for those with a pre-vaccination titer of 10 or greater, a minimum 4-fold rise in post-vaccination antibody titer.|Day 200|The modified intent-to-treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported|||percentage of participants||95% Confidence Interval|Number
2539973|NCT03058692|Secondary|The Percentage of Subjects Achieving Neutralizing Antibody Seroconversion to IIV4 Vaccine Virus at Day 172|Blood was collected from participants for testing in the neutralizing antibody assay with the vaccine viruses as the assay antigens. Seroconversion was defined as a pre-vaccination titer less than 10 and post-vaccination titer greater than or equal to 40, or for those with a pre-vaccination titer of 10 or greater, a minimum 4-fold rise in post-vaccination antibody titer.|Day 172|The modified intent-to-treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported|||percentage of participants||95% Confidence Interval|Number
2539974|NCT03058692|Secondary|The Percentage of Subjects Achieving HAI Seroconversion to IIV4 Vaccine Virus at Day 200|Blood was collected from participants for testing in the HAI assay with the vaccine viruses as the assay antigens. Seroconversion was defined as a pre-vaccination titer less than 10 and post-vaccination titer greater than or equal to 40, or for those with a pre-vaccination titer of 10 or greater, a minimum 4-fold rise in post-vaccination antibody titer.|Day 200|The modified intent-to-treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported|||percentage of participants||95% Confidence Interval|Number
2539975|NCT03058692|Secondary|The Percentage of Subjects Achieving Hemagglutination Inhibition Antibody (HAI) Seroconversion to IIV4 Vaccine Virus at Day 172|Blood was collected from participants for testing in the HAI assay with the vaccine viruses as the assay antigens. Seroconversion was defined as a pre-vaccination titer less than 10 and post-vaccination titer greater than or equal to 40, or for those with a pre-vaccination titer of 10 or greater, a minimum 4-fold rise in post-vaccination antibody titer.|Day 172|The modified intent-to-treat (mITT) population includes all participants who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported|||percentage of participants||95% Confidence Interval|Number
2539976|NCT03058692|Secondary|Incidence of Unsolicited Non-serious Adverse Events (AEs) After M-001 Vaccination|Unsolicited adverse events were collected from the time of first vaccination and at each follow-up visit through Day 43. Adverse events were defined as any untoward medical occurrence regardless of its causal relationship to the study treatment. Events were coded with MedDRA and are reported by System Organ Class.|Day 1 through Day 43|The Safety Analysis population includes all participants who received at least one dose of study product.|||participants|||Number
2539977|NCT03058692|Secondary|Number of Participants Reporting Serious Adverse Events (SAEs) After M-001 Vaccination|SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. All events are included regardless of relationship to the study product.|Day 1 through Day 200|The Safety Analysis population includes all participants who received at least one dose of study product.|||Participants|||Count of Participants
2539978|NCT03058692|Primary|Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) After M-001 Vaccination|SAEs included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation or a congenital anomaly/birth defect. Relationship (related or unrelated to the study product) was determined by a site principal investigator blinded to the study product received by the participant.|Day 1 through Day 200|The Safety Analysis population includes all participants who received at least one dose of study product.|||Participants|||Count of Participants
2539979|NCT03058692|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the Second M-001 Vaccination|Participants maintained a memory aid and thermometer to record daily oral temperatures and the occurrence of systemic reactions of feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea, as well as local injection site reactions of pain, tenderness, redness, and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Fever was defined as an oral temperature of 38 degree Celsius or higher. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days post vaccination.|Day 22 through Day 29|The Safety Analysis population includes all participants who received the second study product.|||Participants|||Count of Participants
2540035|NCT03057366|Primary|Part A: AUClast: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Pevonedistat||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK evaluable population included all enrolled participants who received the protocol-specified single [14C]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
2539980|NCT03058692|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactogenicity Events After the First M-001 Vaccination|Participants maintained a memory aid and thermometer to record daily oral temperatures and the occurrence of systemic reactions of feverishness, fatigue, malaise, myalgia, arthralgia, headache, and nausea, as well as local injection site reactions of pain, tenderness, redness, and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Fever was defined as an oral temperature of 38 degree Celsius or higher. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days post vaccination.|Day 1 through Day 8|The Safety Analysis population includes all participants who received the first study product.|||Participants|||Count of Participants
2539981|NCT03058692|Primary|Number of Participants With Clinical Safety Laboratory Adverse Events After Second M-001 Vaccination|Clinical safety laboratory adverse events included WBC less than or equal to 3900/uL or greater than or equal to 10,600/uL; platelets less than or equal to 139,000/uL or greater than or equal to 416,000/uL; hemoglobin less than or equal to 11.4 g/dL (female) or less than or equal to 12.4 g/dL (male); alanine aminotransferase (ALT) greater than or equal to 44 IU/L (female) or greater than or equal to 61 IU/L (male); creatinine greater than or equal to 1.1 mg/dL (female) or greater than or equal to 1.4 (male); and total bilirubin greater than or equal to 1.30 mg/dL.|Day 22 through Day 29|The Safety Analysis population includes all participants who received the second dose of study product and have a result reported for the parameter.|||Participants|||Count of Participants
2539982|NCT03058692|Primary|Number of Participants With Clinical Safety Laboratory Adverse Events After the First M-001 Vaccination|Blood was collected after first vaccination for assessment by a central clinical laboratory. Clinical safety laboratory adverse events included white blood cells (WBC) </=3900/uL or >/=10,600/uL; platelets </=139,000/uL or >/=416,000/uL; hemoglobin </=11.4 g/dL (female) or </=12.4 g/dL (male); alanine aminotransferase (ALT) >/=44 IU/L (female) or >/=61 IU/L (male); creatinine >/=1.1 mg/dL (female) or >/=1.4 (male); and total bilirubin >/=1.30 mg/dL.|Day 9|The Safety Analysis population includes all participants who received the first dose of study product and have a result reported for the parameter.|||Participants|||Count of Participants
2539983|NCT03058692|Primary|Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2539984|NCT03058692|Primary|Mean Percentage of Perforin- CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2539985|NCT03058692|Primary|Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2539986|NCT03058692|Primary|Mean Percentage of Perforin- CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2539987|NCT03058692|Primary|Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540098|NCT03056144|Primary|Areal Bone Mineral Density of Total Body (Excluding Head)|Areal bone mineral density of total body (excluding head) will be measured in grams/cm2|4 weeks||||g/cm2||Standard Deviation|Mean
2540099|NCT03056144|Primary|Areal Bone Mineral Density of Femur|Areal bone mineral density of femur will be measured in grams/cm2|4 weeks|||||||
2539988|NCT03058692|Primary|Mean Percentage of Perforin- CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2539989|NCT03058692|Primary|Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2539990|NCT03058692|Primary|Mean Percentage of Perforin- CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2539991|NCT03058692|Primary|Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2539992|NCT03058692|Primary|Mean Percentage of Perforin- CD107a+IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2539993|NCT03058692|Primary|Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2539994|NCT03058692|Primary|Mean Percentage of Perforin- CD107a+IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2539995|NCT03058692|Primary|Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540100|NCT03056144|Primary|Bone Mineral Content of Whole Body (Excluding Head)|Whole body (excluding head) BMC will be measured in grams|4 weeks|||||||
2540101|NCT03056144|Primary|Bone Mineral Content of Femur|Distal femur BMC will be measured in grams|4 weeks|||||||
2540102|NCT03056144|Primary|Body Mass Index|calculated based on body height and weight in terms of kg/m2|4 weeks|||||||
2539996|NCT03058692|Primary|Mean Percentage of Perforin- CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2539997|NCT03058692|Primary|Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2539998|NCT03058692|Primary|Mean Percentage of Perforin- CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2539999|NCT03058692|Primary|Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540000|NCT03058692|Primary|Mean Percentage of Perforin+CD107a- IL-2- TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540001|NCT03058692|Primary|Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540002|NCT03058692|Primary|Mean Percentage of Perforin+CD107a- IL-2- TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540003|NCT03058692|Primary|Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540103|NCT03056144|Primary|Body Weight|measure weight in kilograms|4 weeks|||||||
2540104|NCT03056144|Primary|Body Height|measure height in cm|4 weeks|||||||
2541251|NCT03030638|Secondary|Baseline Characteristics of New Users of Indacaterol: Gender|Baseline characteristics of patients in treatment group by data source: Gender|Baseline|Study population|||Participants|||Count of Participants
2540004|NCT03058692|Primary|Mean Percentage of Perforin+CD107a- IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540005|NCT03058692|Primary|Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540006|NCT03058692|Primary|Mean Percentage of Perforin+CD107a- IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540007|NCT03058692|Primary|Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540008|NCT03058692|Primary|Mean Percentage of Perforin+CD107a+IL-2-TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540009|NCT03058692|Primary|Mean Percentage of Perforin+CD107a+IL-2- TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540010|NCT03058692|Primary|Mean Percentage of Perforin+CD107a+IL-2-TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540011|NCT03058692|Primary|Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540119|NCT03055988|Secondary|Change From Baseline in Central Systolic Pressure After 6 Weeks of Treatment|Change from baseline in central systolic pressure is presented.|Baseline and 6 weeks|FAS-EE set including participants with available data for change from baseline in central systolic pressure.|||mmHg||Standard Error|Least Squares Mean
2540012|NCT03058692|Primary|Mean Percentage of Perforin+CD107a+IL-2+TNF- IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540013|NCT03058692|Primary|Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg- CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540014|NCT03058692|Primary|Mean Percentage of Perforin+CD107a+IL-2+TNF+IFNg+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540015|NCT03058692|Primary|Mean Percentage of Interferon Gamma Positive (IFNg+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540016|NCT03058692|Primary|Mean Percentage of Tumor Necrosis Factor Positive (TNF+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540017|NCT03058692|Primary|Mean Percentage of Interleukin-2 Positive (IL-2+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540018|NCT03058692|Primary|Mean Percentage of Cluster of Differentiation 107a Positive (CD107a+) CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540019|NCT03058692|Primary|Mean Percentage of Perforin+ CD4+ and CD8+ T Cells After Stimulation With M-001 Component Peptides|The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.|Day 1 through Day 36|The modified intent-to-treat (mITT) population includes all subjects who received at least one dose of study vaccine and contributed at least one post-study vaccination venous blood sample for immunogenicity testing for which valid results were reported.|||percentage of cells||95% Confidence Interval|Mean
2540155|NCT03055494|Secondary|Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 52|Psoriasis Area and Severity Index 90|52 weeks|FAS|||Participants|||Count of Participants
2540021|NCT03057704|Secondary|Subject's Recall of Injection Discomfort|"Investigator asks patient if they recall discomfort during injection after the procedure.~Patient's verbal rating and recall of pain during injection.~We used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question:~How would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale:~None (0)~Mild (1)~Moderate (2)~Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome)."|This occurs 30 minutes after the subject's procedure is finished in the recovery room; lasts 30 seconds one time only||||units on a scale||Standard Deviation|Mean
2540022|NCT03057704|Primary|Patient Expression of Pain|"Patient's verbal rating of pain during injection (see link to study protocol)~We used a Verbal Rating Scale from the patient that self-described discomfort level during injection using question:~How would you rate your pain using None, Mild, Moderate, Severe and record it on this 4-point scale:~None (0)~Mild (1)~Moderate (2)~Severe (3) None is no pain (best outcome) and Severe is worst pain possible (worst outcome)."|During injection at beginning of study; lasts 10 seconds one time only||||units on a scale||Standard Deviation|Mean
2540023|NCT03057366|Secondary|Part B: Number of Participants With Best Overall Response as Per Investigator's Assessment|The best overall response was defined as the participants with best response among complete response (CR) or partial response (PR) or stable disease (SD), or progressive disease (PD). It was assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than (<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters as the best overall response after randomization. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Up to Cycle 11 (Cycle length =21 days)|The response-evaluable population included all participants who received at least 1 dose of study drug in Part B, had measurable disease as entry criteria for Part B, and had at least 1 post-baseline disease assessment.|||Participants|||Count of Participants
2540024|NCT03057366|Secondary|Part A: Percent Distribution of Total Radioactivity (TRA) for Pevonedistat and Its Metabolites in Plasma, Urine and Feces||Up to 168 hours post-dose|The PK evaluable population included all enrolled participants who received the protocol-specified single [14C]-pevonedistat dose in Part A and did not received any excluded medications throughout the completion of Part A and had sufficient concentration-time data.|||percentage distribution of TRA||Standard Deviation|Mean
2540025|NCT03057366|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||Part A: From first dose of study drug in Part A up to Day 31; Part B: From first dose of study drug in Part B up to Cycle 11 Day 35 (Cycle length is equal to [=] 21 days)|The safety analysis set is defined as all enrolled participants who received at least 1 dose of [14C]-pevonedistat during Part A.|||Participants|||Count of Participants
2540026|NCT03057366|Primary|Part A: Renal Clearance (CLR) for Pevonedistat||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK evaluable population included all enrolled participants who received the protocol-specified single [14C]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.|||liter per hour (L/hr)||Standard Deviation|Mean
2540027|NCT03057366|Primary|Part A: Feurine: Cumulative Percentage of Pevonedistat Dose Excreted in Urine at 144-168 Hours Post-dose||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK evaluable population included all enrolled participants who received the protocol-specified single [14C]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.|||percentage of dose||Standard Deviation|Mean
2540028|NCT03057366|Primary|Part A: Aeurine: Cumulative Amount of Pevonedistat Dose Excreted in Urine at 144-168 Hours Post-dose||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK evaluable population included all enrolled participants who received the protocol-specified single [14C]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.|||microgram (mcg)||Standard Deviation|Mean
2540029|NCT03057366|Primary|Part A: Aetotal,14C: Total Cumulative Excretion of [14C]-Pevonedistat From the Body||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK evaluable population included all enrolled participants who received the protocol-specified single [14C]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.|||mcg eq||Standard Deviation|Mean
2540030|NCT03057366|Primary|Part A: Aefeces,14C: Cumulative Amount of [14C]-Pevonedistat Excreted in Feces up to the Last Sampling Interval||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK evaluable population included all enrolled participants who received the protocol-specified single [14C]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.|||mcg eq||Standard Deviation|Mean
2540031|NCT03057366|Primary|Part A: Aeurine,14C: Cumulative Amount of [14C]-Pevonedistat Excreted in Urine up to the Last Sampling Interval||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK evaluable population included all enrolled participants who received the protocol-specified single [14C]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.|||microgram equivalent (mcg eq)||Standard Deviation|Mean
2540032|NCT03057366|Primary|Part A: AUClast: Area Under the Plasma and Whole Blood TRA Concentration Curve From Time 0 to Time of the Last Quantifiable Concentration for [14C]-Pevonedistat Drug-related Material||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK evaluable population included all enrolled participants who received the protocol-specified single [14C]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.|||hour*nanogram equivalent per milliliter||Standard Deviation|Mean
2540841|NCT03040011|Secondary|POD 2 Narcotic Consumption|The total amount of narcotic pain medication used on postoperative day 2 was calculated and measured in oral morphine equivalents.|Postoperative day 2||||oral morphine equivalents||Inter-Quartile Range|Median
2540036|NCT03057366|Primary|Part A: Tmax: Time to Reach the Maximum Plasma and Whole Blood Concentration (Cmax) for Pevonedistat||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK evaluable population included all enrolled participants who received the protocol-specified single [14C]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.|||hour||Full Range|Median
2540037|NCT03057366|Primary|Part A: Cmax: Maximum Observed Plasma and Whole Blood Concentration for Pevonedistat||Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose|The pharmacokinetic (PK) evaluable population included all enrolled participants who received the protocol-specified single [14C]-pevonedistat dose in Part A and did not receive any excluded medications throughout the completion of Part A and had sufficient concentration-time data.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2540038|NCT03057132|Primary|Pain Scores at the Primary Site Assessed|Improvement in pain from baseline to the end of the study. The Wong-Baker FACES® Pain Visual Analog Pain Scale was used to assess pain at each time point. Pain was assessed on a 0 (no pain) to 10 (worst pain) grading scale. Lower score is better.|Baseline, 3 days|Pain was rated during and after cleansing at baseline and at Day 3, and during and after product application at baseline.|||units on a scale|||Number
2540039|NCT03057132|Primary|Percent of Epidermal Skin Loss at the Primary Site Assessed|"The primary endpoint is the improvement of denuded skin (defined as clinical improvement from the baseline skin assessment) of the primary site of interest (ostomy).~The primary response was the percent of skin at primary site of interest with epidermal loss observed at baseline and at 3 days post product application."|Baseline, 3 days|One application of Cavilon Advanced Skin Protectant was applied around the ostomy site. Skin was assessed at baseline and at 3 days after product application.|||Percentage of epidermal skin loss|||Number
2540040|NCT03056573|Secondary|Number of Participants With Overall Acute Device Success|"Acute device success is defined as a subject who achieves a) successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system, b) correct position of the device in the proper anatomical location, c) intended performance of the prosthetic heart valve, and d) only 1 valve implanted in the proper anatomical location.~Device success is a 'technical' composite endpoint meant to characterize the acute device and procedural factors which underlie vascular access, delivery, and performance of the TAVI system. Echocardiography should be routinely utilized as the standard for measuring prosthetic valve stenosis and regurgitation immediately after TAVI, and should always be performed in a resting state, either within 24-48 h after the index procedure or before hospital discharge."|7 days|The number of participants who were available at that time point were included|||Participants|||Count of Participants
2540041|NCT03056573|Secondary|Change in Effective Orifice Area From Baseline as Compared to 30 Days|Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve.|Baseline to 30 days.|We had presented the data only for the participants who had an outcome at baseline and at 30 days (paired data).|||cm2||Standard Deviation|Mean
2540042|NCT03056573|Secondary|Change in Six Minute Walk Test From Baseline as Compared to 30 Days|The Six Minute Walk Test (6MWT)measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.|Baseline to 30 days|We had presented the data only for the participants who had an outcome at baseline and at 30 days (paired data).|||Meter||Standard Deviation|Mean
2540043|NCT03056573|Secondary|Change in NYHA Class From Baseline to 30 Days|"New York Heart Association (NYHA) functional classification provides a way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina pain.~Class I. Patients with cardiac disease but without resulting limitation of physical activity.~Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.~Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.~Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest."|Baseline to 30 days|We had presented the data only for the participants who had an outcome at baseline and at 30 days (paired data).|||Participants|||Count of Participants
2540044|NCT03056573|Secondary|Number of Participants With Moderate and Severe Aortic Regurgitation||1 year|The number of participants who were available at that time point were included|||Participants|||Count of Participants
2540045|NCT03056573|Secondary|Number of Participants With Composite of Periprocedural Encephalopathy, All Stroke and All TIA|"Stroke is an acute symptomatic episode of neurological dysfunction attributed to a vascular cause.~Transient Ischemic Attack (TIA) is a transient (less than 24 hrs) episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. No evidence of infarction if imaging performed.~Encephalopathy is defined as altered mental state (e.g., seizures, delirium, confusion, hallucinations, dementia, coma, psychiatric episode)."|1 Year||||Participants|||Count of Participants
2540046|NCT03056573|Secondary|Number of Participants With Composite of Periprocedural Encephalopathy, All Stroke and All TIA|"Stroke is an acute symptomatic episode of neurological dysfunction attributed to a vascular cause.~Transient Ischemic Attack (TIA) is a transient (less than 24 hrs) episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. No evidence of infarction if imaging performed.~Encephalopathy is defined as altered mental state (e.g., seizures, delirium, confusion, hallucinations, dementia, coma, psychiatric episode)."|30 Days||||Participants|||Count of Participants
2540047|NCT03056573|Secondary|Number of Participants With Acute Kidney Injury Requiring Dialysis|Increase in serum creatinine to greater than or equal to 300% (3 X increase compared with baseline) or serum creatinine of ≥ 4.0 mg/dL (354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)or Urine output <0.3 mL/kg per hour for ≥24 hours or anuria for ≥12 hours. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria|1 Year||||Participants|||Count of Participants
2540842|NCT03040011|Secondary|POD 1 Narcotic Consumption|The total amount of narcotic pain medication used on postoperative day 1 was calculated and measured in oral morphine equivalents.|Postoperative day 1||||oral morphine equivalents||Inter-Quartile Range|Median
2540048|NCT03056573|Secondary|Number of Participants With Acute Kidney Injury Requiring Dialysis|Increase in serum creatinine to greater than or equal to 300% (3 X increase compared with baseline) or serum creatinine of ≥ 4.0 mg/dL (354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)or Urine output <0.3 mL/kg per hour for ≥24 hours or anuria for ≥12 hours. Patients receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria|30 Days||||Participants|||Count of Participants
2540049|NCT03056573|Secondary|Number of Participants With Life Threatening Bleeding Requiring Transfusion|"Life threatening bleeding requiring transfusion~Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0 g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND~Does not meet criteria of life-threatening or disabling bleeding"|1 Year||||Participants|||Count of Participants
2540050|NCT03056573|Secondary|Number of Participants With Life Threatening Bleeding Requiring Transfusion|"Life threatening bleeding requiring transfusion~Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0 g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND~Does not meet criteria of life-threatening or disabling bleeding"|30 Days||||Participants|||Count of Participants
2540051|NCT03056573|Secondary|Number of Participants With Non-disabling Strokes|Non-disabling is an mRS score of <2 at 90 days or 1 that does not result in an increase of at least 1 mRS category from an individual's prestroke baseline|1 Year||||Participants|||Count of Participants
2540052|NCT03056573|Secondary|Number of Participants With Non-disabling Strokes|Non-disabling is an mRS score of <2 at 90 days or 1 that does not result in an increase of at least 1 mRS category from an individual's prestroke baseline|30 Days||||Participants|||Count of Participants
2540053|NCT03056573|Secondary|Number of Participants With Disabling Stroke|Disabling stroke is an mRS score of 2 or more at 90 days and an increase of at least 1 mRS category from an individual's prestroke baseline|1 Year||||Participants|||Count of Participants
2540054|NCT03056573|Secondary|Number of Participants With Disabling Stroke|Disabling stroke is an mRS score of 2 or more at 90 days and an increase of at least 1 mRS category from an individual's prestroke baseline|30 Days||||Participants|||Count of Participants
2540055|NCT03056573|Secondary|Cardiovascular Mortality|"Any 1 of the following criteria:~Death due to proximate cardiac cause (e.g., myocardial infarction, cardiac tamponade, worsening heart failure)~Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease.~All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure~All valve-related deaths including structural or nonstructural valve dysfunction or other valve-related adverse events~Sudden or unwitnessed death~Death of unknown cause"|1 year||||Participants|||Count of Participants
2540056|NCT03056573|Secondary|Cardiovascular Mortality|"Any 1 of the following criteria:~Death due to proximate cardiac cause (e.g., myocardial infarction, cardiac tamponade, worsening heart failure)~Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease.~All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure~All valve-related deaths including structural or nonstructural valve dysfunction or other valve-related adverse events~Sudden or unwitnessed death~Death of unknown cause"|30 Days||||Participants|||Count of Participants
2540057|NCT03056573|Secondary|Number of All- Cause Mortality||1 Year||||Participants|||Count of Participants
2540058|NCT03056573|Secondary|Number of All- Cause Mortality||30 Days||||Participants|||Count of Participants
2540059|NCT03056573|Primary|Number of Participants With Major Vascular Complications|"Major Vascular complication is defined as~Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudo-aneurysm or~Access site or access-related vascular injury leading to death, life-threatening or major bleeding, visceral ischaemia or neurological impairment or~Distal embolization from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage or~The use of unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischaemia or neurological impairment or~Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram or~Surgery for access site-related nerve injury or~Permanent access site-related nerve injury"|30 Days||||Participants|||Count of Participants
2540060|NCT03056352|Secondary|Number of Participants Satisfied With Medication; Assessed by Self-evaluation|"Satisfaction is measured by a positive response to the question Would you want to receive the same medication during a subsequent visit for post-traumatic headache?"|48 hours after treatment|2 patients did not provide an answer to this question|||Participants|||Count of Participants
2540061|NCT03056352|Secondary|Post Concussion Symptoms Assessed by Post-concussive Symptom Scale|The post-concussive symptom scale is a questionnaire administered verbally. The post-concussive symptom ranges from 0 to 132. 0= no post-concussive symptoms. 132= severe post-concussive symptoms.|7 days|2 patients were lost to followup|||units on a scale||Standard Deviation|Mean
2540062|NCT03056352|Primary|Number of Participants With Sustained Headache Relief|"Sustained headache relief is defined as achieving a headache level of mild or none within two hours and maintaining a level of mild or none for 48 hours. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after medication administration."|2 hours thru 48 hours after treatment||||Participants|||Count of Participants
2540063|NCT03056300|Primary|Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding|"Incidence of hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of PVS:~Hemostasis intervention: bleeding that occurs post-operatively requiring blood or blood product transfusion or an additional surgical procedure (related to PA and PV transection).~No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection)."|Post-op through 4 week follow-up|All enrolled subjects in whom a procedure was started.|||Percentage||95% Confidence Interval|Number
2551297|NCT02819804|Other Pre-specified|Overall Survival (OS)|OS is defined as the time from the initiation of study treatment until death from any cause, evaluated for up to 1 year.|Up to 1 year|||||||
2540064|NCT03056300|Primary|Incidence of Intra-Operative Hemostatic Interventions|Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open).|Intra-Operative|All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions|||Percentage of vessel transections|Vessel Transections|95% Confidence Interval|Number
2540065|NCT03056144|Primary|Segmental Assessment of Trunk Control-reactive|assess the segmental trunk control in sitting position with an ordinal score will be given in reactive trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.|4 weeks||||score on a scale||Inter-Quartile Range|Median
2540066|NCT03056144|Primary|Segmental Assessment of Trunk Control_active|assess the segmental trunk control in sitting position with an ordinal score will be given in active trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.|4 weeks||||score on a scale||Inter-Quartile Range|Median
2540067|NCT03056144|Secondary|Visual Analogue Scale|record discomfort during the intervention in a scale of 0 (no discomfort) to 10 (maximal discomfort).|4 weeks||||score on a scale|||Number
2540068|NCT03056144|Secondary|Percentage of Attendance of Participants|record the percentage of attendance and comments during the intervention|4 weeks||||percentage of attendance|||Number
2540069|NCT03056144|Primary|Muscle Strength of Left Ankle Plantarflexors|measure muscle strength of ankle plantarflexors in sitting using dynamometer in terms of Newton|4 weeks|||||||
2540070|NCT03056144|Primary|Muscle Strength of Right Ankle Plantarflexors|measure muscle strength of ankle plantarflexors in sitting using dynamometer in terms of Newton|4 weeks|||||||
2540071|NCT03056144|Primary|Muscle Strength of Left Ankle Dorsiflexors|measure muscle strength of ankle dorsiflexors in sitting using dynamometer in terms of Newton|4 weeks|||||||
2540072|NCT03056144|Primary|Muscle Strength of Right Ankle Dorsiflexors|measure muscle strength of ankle dorsiflexors in sitting using dynamometer in terms of Newton|4 weeks|||||||
2540073|NCT03056144|Primary|Muscle Strength of Left Hip Abductors|measure muscle strength of hip abductors in supine using dynamometer in terms of Newton|4 weeks|||||||
2540074|NCT03056144|Primary|Muscle Strength of Right Hip Abductors|measure muscle strength of hip abductors in supine using dynamometer in terms of Newton|4 weeks|||||||
2540075|NCT03056144|Primary|Muscle Strength of Left Knee Extensors|measure muscle strength of knee extensors in sitting using dynamometer in terms of Newton|4 weeks|||||||
2540076|NCT03056144|Primary|Muscle Strength of Right Knee Extensors|measure muscle strength of knee extensors in sitting using dynamometer in terms of Newton|4 weeks|||||||
2540077|NCT03056144|Primary|Muscle Strength of Left Knee Flexors|measure muscle strength of knee flexors in sitting using dynamometer in terms of Newton|4 weeks|||||||
2540078|NCT03056144|Primary|Muscle Strength of Right Knee Flexors|measure muscle strength of knee flexors in sitting using dynamometer in terms of Newton|4 weeks|||||||
2540079|NCT03056144|Primary|Muscle Strength of Left Hip Extensors|measure muscle strength of hip extensors in prone using dynamometer in terms of Newton|4 weeks|||||||
2540080|NCT03056144|Primary|Muscle Strength of Right Hip Extensors|measure muscle strength of hip extensors in prone using dynamometer in terms of Newton|4 weeks|||||||
2540081|NCT03056144|Primary|Muscle Strength of Left Hip Flexors|measure muscle strength of hip flexors in supine using dynamometer in terms of Newton|4 weeks|||||||
2540082|NCT03056144|Primary|Muscle Strength of Right Hip Flexors|measure muscle strength of hip flexors in supine using dynamometer in terms of Newton|4 weeks|||||||
2540083|NCT03056144|Primary|Range of Left Ankle Plantarflexion|measure ankle plantarflexion in sitting using goniometer in degrees|4 weeks|||||||
2540084|NCT03056144|Primary|Range of Right Ankle Plantarflexion|measure ankle plantarflexion in sitting using goniometer in degrees|4 weeks|||||||
2540085|NCT03056144|Primary|Range of Left Ankle Dorsiflexion|measure ankle dorsiflexion in sitting using goniometer in degrees|4 weeks|||||||
2540086|NCT03056144|Primary|Range of Right Ankle Dorsiflexion|measure ankle dorsiflexion in sitting using goniometer in degrees|4 weeks|||||||
2540087|NCT03056144|Primary|Range of Left Knee Extension|measure knee extension in sitting using goniometer in degrees|4 weeks|||||||
2540088|NCT03056144|Primary|Range of Right Knee Extension|measure knee extension in sitting using goniometer in degrees|4 weeks|||||||
2540089|NCT03056144|Primary|Range of Left Knee Flexion|measure knee flexion in prone using goniometer in degrees|4 weeks|||||||
2540090|NCT03056144|Primary|Range of Right Knee Flexion|measure knee flexion in prone using goniometer in degrees|4 weeks|||||||
2540091|NCT03056144|Primary|Range of Left Hip Abduction|measure hip abduction in supine using goniometer in degrees|4 weeks|||||||
2540092|NCT03056144|Primary|Range of Right Hip Abduction|measure hip abduction in supine using goniometer in degrees|4 weeks|||||||
2540093|NCT03056144|Primary|Range of Left Hip Extension|measure hip extension in prone using goniometer in degrees|4 weeks|||||||
2540094|NCT03056144|Primary|Range of Right Hip Extension|measure hip extension in prone using goniometer in degrees|4 weeks|||||||
2540095|NCT03056144|Primary|Range of Left Hip Flexion|measure hip flexion in supine using goniometer in degrees|4 weeks|||||||
2540096|NCT03056144|Primary|Range of Right Hip Flexion|measure hip flexion in supine using goniometer in degrees|4 weeks|||||||
2540097|NCT03056144|Primary|Volumetric Bone Mineral Density of Lumbar Spine|Volumetric bone mineral density of lumbar spine (L2 to L4) in grams/cm3|4 weeks|||||||
2540105|NCT03056144|Primary|Pediatric Evaluation of Disability Inventory|assess functional capacities in the domains of self care, mobility and social function with a summary score in each domain. A dichotomous score will be given to each question in each domain: 0= unable and 1= able. In self care domain, there are 73 questions, i.e. maximal score is 73. In mobility domain, there are 59 questions i.e. maximal score is 59. In social function domain, there are 65 questions i.e. maximal score is 65.|4 weeks||||score on a scale||Standard Deviation|Mean
2540106|NCT03056144|Primary|Segmental Assessment of Trunk Control-static|assess the segmental trunk control in sitting position with an ordinal score will be given in static trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.|4 weeks||||score on a scale||Inter-Quartile Range|Median
2540107|NCT03056144|Primary|2-minute Walk Test|assess submaximal exercise capacity by measuring the distance covered in the 2 minutes in metres|4 weeks|||||||
2540108|NCT03056144|Primary|North Star Ambulatory Assessment|examine the gross motor function of the participants. A summed score will be added from each test item.|4 weeks|||||||
2540109|NCT03056040|Secondary|Percentage Of Participants With Stabilized Hemoglobin Levels|Stabilized hemoglobin was defined as avoidance of a ≥2 g/dL decrease in hemoglobin level from Baseline in the absence of transfusion through Day 183.|Baseline through Day 183|Full Analysis Set: All participants who received at least 1 dose of randomized treatment (ravulizumab or eculizumab).|||percentage of participants||95% Confidence Interval|Number
2540110|NCT03056040|Secondary|Percentage Of Participants Who Achieved Transfusion Avoidance|Transfusion avoidance was defined as the percentage of participants who remained transfusion free and did not require a transfusion per protocol-specified guidelines (hemoglobin value of ≤9 g/dL with signs or symptoms of sufficient severity to warrant a transfusion, or a hemoglobin value of ≤7 g/dL regardless of presence of clinical signs or symptoms) through Day 183.|Baseline through Day 183|Full Analysis Set: All participants who received at least 1 dose of randomized treatment (ravulizumab or eculizumab).|||percentage of participants||95% Confidence Interval|Number
2540111|NCT03056040|Secondary|Change From Baseline To Day 183 In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Scores|FACIT-Fatigue score ranges from 0 to 52, with a higher score indicating less fatigue. Baseline was defined as the last non-missing assessment value prior to first study drug dose. Change in FACIT-Fatigue score from Baseline to Day 183 was analyzed using an MMRM with the fixed, categorical effects of treatment, the stratification randomization indicator of packed red blood cells transfusion history (yes/no within 12 months prior to Day 1), study visit, and study visit by treatment group interaction, as well as the continuous fixed covariate of Baseline FACIT-Fatigue score.|Baseline, Day 183|Full Analysis Set: All participants who received at least 1 dose of randomized treatment (ravulizumab or eculizumab).|||units on a scale||95% Confidence Interval|Least Squares Mean
2540112|NCT03056040|Secondary|Percentage Of Participants With Breakthrough Hemolysis|Breakthrough hemolysis (BTH) was defined as at least one new or worsening symptom or sign of intravascular hemolysis (fatigue, hemoglobinuria, abdominal pain, dyspnea, anemia [hemoglobin <10 grams (g)/deciliter (dL)], major adverse vascular event [including thrombosis], dysphagia, or erectile dysfunction) in the presence of elevated LDH ≥2 times the upper limit of normal (ULN).|Baseline through Day 183|Full Analysis Set: All participants who received at least 1 dose of randomized treatment (ravulizumab or eculizumab).|||percentage of participants||95% Confidence Interval|Number
2540113|NCT03056040|Primary|Percent Change In Lactate Dehydrogenase Levels From Baseline To Day 183|Lactate dehydrogenase (LDH) is an indicator of intravascular hemolysis that occurs in participants with paroxysmal nocturnal hemoglobinuria. A decrease in LDH indicates reduction (improvement) in hemolysis. Baseline was defined as the average of all available on-study assessments prior to the first study drug infusion. The percent change in LDH was analyzed using a mixed-effect model for repeated measures (MMRM) with the fixed, categorical effects of treatment, study visit, and study visit by treatment group interaction, as well as the continuous, fixed covariate of baseline LDH and the stratification randomization indicator of packed red blood cells transfusion history (yes/no within 12 months prior to Day 1).|Baseline, Day 183|Full Analysis Set: All participants who received at least 1 dose of randomized treatment (ravulizumab or eculizumab).|||percent change||95% Confidence Interval|Least Squares Mean
2540114|NCT03055988|Secondary|Change From Baseline in 1.5 Hour Post Dose Forced Vital Capacity (FVC) After 6 Weeks of Treatment|Change from baseline in 1.5 hour post dose Forced Vital Capacity (FVC) is presented.|Baseline and 6 weeks|FAS-EE set including participants with available data for change from baseline in FVC.|||Litre (L)||Standard Error|Least Squares Mean
2540115|NCT03055988|Secondary|Change From Baseline in 1.5 Hour Post Dose Forced Expiratory Volume in 1st Second (FEV1) After 6 Weeks of Treatment|Change from baseline in 1.5 hour post dose Forced Expiratory Volume in 1st second (FEV1) is presented.|Baseline and 6 weeks|FAS-EE set including participants with available data for change from baseline in FEV1.|||Litre (L)||Standard Error|Least Squares Mean
2540116|NCT03055988|Secondary|Change From Baseline in Functional Residual Capacity Body Plethysmography (FRCpleth) % Predicted After 6 Weeks of Treatment|Change from Baseline in Functional Residual Capacity Body Plethysmography (FRCpleth) % predicted is presented. Functional residual capacity, percent predicted is a lung volume at the end of normal expiration assessed/measured by body plethysmography and compared to predicted capacity for such subject, if nonsmoker and without a disease which could compromise their ventilator function, to give a percentage predicted.|Baseline and 6 weeks|FAS-EE set including participants with available data for change from baseline in FRCpleth.|||Percentage of FRCpleth (%)||Standard Error|Least Squares Mean
2540117|NCT03055988|Secondary|Change From Baseline in Aortic Augmentation Index After 6 Weeks of Treatment|Change from baseline in aortic augmentation index is presented. Augmentation index was derived from brachial pulse wave separation analysis as augmentation pressure (pressure difference between the reflection wave to the ejection wave) divided by central pulse pressure (at the central aortic site) multiplied by 100.|Baseline and 6 weeks|FAS-EE set including participants with available data for change from baseline in aortic augmentation index.|||Percentage of index (%)||Standard Error|Least Squares Mean
2540118|NCT03055988|Secondary|Change From Baseline in Pulse Pressure After 6 Weeks of Treatment|Change from baseline in pulse pressure is presented.|Baseline and 6 weeks|FAS-EE set including participants with available data for change from baseline in pulse pressure.|||mmHg||Standard Error|Least Squares Mean
2540120|NCT03055988|Secondary|Change From Baseline in Pulmonary Artery Pulsatility After 6 Weeks of Treatment|Change from baseline in pulmonary artery pulsatility (PAP) is presented. Pulmonary artery pulsatility measurements as measure of arterial stiffness were derived from cine images acquired at end-expiration in planes perpendicular to the thoracic aorta at the level of the pulmonary artery (ascending and descending section of thoracic aorta), abdominal aorta, and perpendicularly to the main, right, and left pulmonary arteries.|Baseline and 6 weeks|FAS-EE set including participants with available data for change from baseline in pulmonary artery pulsatility.|||Percentage of PAP (%)||Standard Error|Least Squares Mean
2540121|NCT03055988|Secondary|Change From Baseline in Aortic Distensibility After 6 Weeks of Treatment|Change from baseline in aortic distensibility is presented. Aortic distensibility measurements as measure of arterial stiffness were derived from cine images acquired at end-expiration in planes perpendicular to the thoracic aorta at the level of the pulmonary artery (ascending and descending section of thoracic aorta), abdominal aorta, and perpendicularly to the main, right, and left pulmonary arteries.|Baseline and 6 weeks|FAS-EE set including participants with available data for change from baseline in aortic distensibility.|||Percentage/millimeter of mercury(%/mmHg)||Standard Error|Least Squares Mean
2540122|NCT03055988|Primary|Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVI) in the 6th Week of Treatment|"LVEDVI is normalised left ventricular end diastolic volume, divided by body surface area.~Baseline was defined as the value obtained during the assessment performed in a week prior to Visit 2 (Day 1). The change from baseline was calculated as the value obtained in a week prior to Visits 3 and 4 (end of each treatment periods) minus the baseline value."|Baseline and 6 weeks|FullAnalysisSet (FAS)ExcludingExacerbation (FAS-EE) nested within FAS and data from patients who had an exacerbation during treatments were excluded from this set. FAS nested within treated set and included patients who had baseline measurement and at least one post-baseline measurement for primary or secondary endpoints. (Including available data)|||Millilitre/ meter^2 (mL/m^2)||Standard Error|Least Squares Mean
2540123|NCT03055832|Secondary|Change From Baseline to Post-Treatment in Best Spectacle-Corrected Visual Acuity (BSCVA)|Visual acuity was assessed with spectacles or other visual corrective devices in place using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Results are presented in logarithm of the minimum angle of resolution (logMAR) with 0.2 in logMAR corresponding to 10 ETDRS letters read. A lower logMAR change value indicates an improvement in visual acuity. No formal hypothesis testing was pre-specified for this endpoint.|Baseline (Day 0), Immediately Post-Treatment (Day 0)|All randomized and treated patients|||logMAR|Eyes|Standard Deviation|Mean
2540124|NCT03055832|Secondary|Change From Baseline to Post-Treatment in Intraocular Pressure (IOP)|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A negative change value indicates an improvement. No formal hypothesis testing was pre-specified for this endpoint.|Baseline (Day 0), Immediately Post-Treatment (Day 0)|All randomized and treated patients|||mmHg|Eyes|Standard Deviation|Mean
2540125|NCT03055832|Secondary|Change From Baseline to Post-Treatment in Ocular Surface Staining|Corneal staining was assessed by the examiner using the National Eye Institute corneal grading scale and a slit-lamp. Each of the 5 corneal regions (superior, inferior, central, temporal, & central), was graded on a 0-3 scale, where 0=normal-no staining (best); 1=mild-superficial stippling micropunctate staining; 2=moderate-macropunctate staining with some coalescent areas; and 3=severe-numerous coalescent macropunctate areas and/or patches (worst). The scores were summed for each eye, and an overall corneal staining score was computed as the average of the sum from both eyes. Overall scores ranged between 0-15, with higher change value indicating greater damage to the corneal surface. Assessments were made at baseline (pre-treatment), immediately post-treatment, and Day 1 post-treatment. No formal hypothesis testing was pre-specified for this endpoint.|Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment||||score on a scale|Eyes|Standard Deviation|Mean
2540126|NCT03055832|Secondary|Mean Discomfort Score During Treatment|The patient placed a vertical line on visual analog scale questionnaire using a scale of 0-100 (0 = no discomfort, 100 = maximum discomfort) at the point that indicated the discomfort in or around their eyelids, or face during the procedure including feelings of pressure, tightness, heaviness, burning, and other negative sensations. Assessments were made at baseline (pre-treatment), immediately post-treatment, and Day 1 post-treatment. No formal hypothesis testing was pre-specified for this endpoint.|Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment|All randomized and treated patients|||score on a scale|Eyes|Standard Deviation|Mean
2540127|NCT03055832|Secondary|Mean Pain Score During Treatment|"The patient placed a vertical line on visual analog scale questionnaire using a scale of 0-100 (0 = no pain, 100 = maximum pain) at the point that indicated the pain in or around their eyelids, or face during the procedure including feelings of pressure, tightness, heaviness, burning, and other negative sensations. A score a 20 was associated with a description of hurts a little. Assessments were made at baseline (pre-treatment), immediately post-treatment, and Day 1 post-treatment. No formal hypothesis testing was pre-specified for this endpoint."|Baseline (Day 0), Immediately Post-Treatment (Day 0), Day 1 Post-Treatment|All randomized and treated patients|||score on a scale|Eyes|Standard Deviation|Mean
2540128|NCT03055832|Secondary|Change From Baseline to Week 4 in Ocular Surface Disease Index (OSDI)|"The Ocular Surface Disease Index (OSDI) is a 12-item, patient-reported outcome questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. Each item is scored on a 0-4 Likert-type scale, where 0 is None and 4 is All of the Time. The OSDI is calculated as the (sum of scores) x 25 / (# of questions answered), for a resultant overall score of 0-100, where 0 corresponds to no disability and 100 corresponds to complete disability. A negative change value indicates an improvement."|Baseline, Week 4|All randomized and treated patients|||score on a scale||Standard Deviation|Mean
2540129|NCT03055832|Primary|Incidence (Number) of Device- or Procedure-related Adverse Events|The number of device- or procedure-related adverse events was calculated, including changes from baseline (Yes/No) in any of the following eyelid characteristics: lid margin assessment or development of floppy eyelids or entropion (eyelid rolled inward) or ectropion (eyelid sagging outward) or loss of lash integrity.|Week 4|All randomized and treated patients|||Adverse event|||Number
2540870|NCT03039621|Secondary|Time to Alleviation of Respiratory Symptoms.|Based on patient diary data. Absence of respiratory symptoms/presence of one mild respiratory symptom.|14 days of observation.|ITT sample|||days||95% Confidence Interval|Mean
2540130|NCT03055832|Primary|Change From Baseline to Week 4 in Tear Break-Up Time (TBT)|Tear break-up time (defined as the time required for dry spots to appear on the surface of the eye after blinking) was assessed by the examiner using a slit lamp and fluorescein strips. Fluorescein was instilled onto the patient's eye, after which the patient blinked three times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to record the time between the last blink and the first appearance of a dark spot on the cornea (formation of dry area). Three consecutive measurements were taken and averaged for actual TBT. A positive change value represents a lengthening in the tear break-up time and greater comfort.|Baseline, Week 4|All randomized and treated patients|||seconds|Eyes|Standard Deviation|Mean
2540131|NCT03055832|Primary|Change From Baseline to Week 4 in Meibomian Gland Score (MGS)|Meibomian glands on the lower eyelid were assessed by the examiner using a Meibomian Gland Evaluator while viewing the eyelid margin using a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated. Each gland was scored from 0-3 for a maximum MGS of 45 in each eye. MGS scoring was as follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A positive change value indicates an improvement.|Baseline, Week 4|All randomized and treated patients|||score on a scale|Eyes|Standard Deviation|Mean
2540132|NCT03055806|Secondary|Mean Change From Baseline in Score on Ejaculation-related Personal Distress|Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.|Last 4 weeks of treatment compared to baseline|Results presented for modified Intent To Treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).|||score on a scale||Standard Deviation|Mean
2540133|NCT03055806|Secondary|Mean Change From Baseline in Score on Control of Ejaculation|Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP question on control of timing is scored on a 5 point scale with the scores ranging from very poor (this is the worst answer scored as 0) to very good (this is the best answer scored as 4).|Last 4 weeks of treatment compared to baseline|Results presented for modified Intent To Treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).|||score on a scale||Standard Deviation|Mean
2540134|NCT03055806|Secondary|Proportion of Patients Achieving Change in Category of ≥2 on Control of Timing of Ejaculation and Achieving Change in Category of ≥1 in Ejaculation-related Personal Distress at End of Treatment|Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer).|Baseline to the end of treatment (approximately 8 weeks)|Results presented for modified Intent To Treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).|||Proportion of participants|||Number
2540135|NCT03055806|Secondary|Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 in Ejaculation-related Personal Distress on the Premature Ejaculation Profile (PEP) Questionnaire|Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement. A change in category of ≥1 or ≥2 corresponds to improving distress from 'extremely' to 'moderately', 'a little bit' or 'not at all'; or from 'quite a bit' to 'moderately', 'a little bit' or 'not at all'; or from 'moderately' to 'a little bit' or 'not at all'.|Baseline to the end of treatment (approximately 8 weeks)|Results presented for modified Intent To Treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).|||Proportion of participants|||Number
2540136|NCT03055806|Secondary|Proportion of Patients Achieving Mean Change in Category of ≥1 or ≥2 on Control of Timing of Ejaculation on the Premature Ejaculation Profile (PEP) Questionnaire.|Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer). A mean change in category of ≥1 or ≥2 corresponds to improving control from 'very poor' to 'fair', 'good', or 'very good'; or from 'poor' to 'fair', 'good', or 'very good'.|Baseline to the end of treatment (approximately 8 weeks)|Results presented for modified Intent To Treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).|||Proportion of participants|||Number
2540137|NCT03055806|Secondary|Proportion of Patients Rating Their Premature Ejaculation (PE) as Improved Per the Clinical Global Impression of Change (CGIC) Questionnaire|7 point scale ranging from much worse (-3) to much better (3). The proportion refers to the proportion of patients who had the best 2 possible responses [better (2) or much better (3)] on this scale.|Baseline to the end of treatment (approximately 8 weeks)|Results presented for modified Intent To Treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).|||Proportion of participants|||Number
2540138|NCT03055806|Secondary|Proportion of Patients With ≥2.5-fold Increase in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period Compared With Baseline|Intravaginal Ejaculatory Latency Time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was measured using the stopwatch provided.|Last 4 weeks of treatment compared to baseline|Results presented for modified Intent to treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).|||Proportion of participants|||Number
2540139|NCT03055806|Secondary|Fold Change From Baseline in Geometric Mean (GM) IELT Over the Treatment Assessment Period Compared With Baseline|Intravaginal Ejaculatory Latency Time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was recorded using the stopwatch provided.|Last 4 weeks of treatment compared to baseline|Results presented for modified Intent to treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).|||Fold change||Standard Error|Least Squares Mean
2540220|NCT03054506|Secondary|Patient's Assessment of Abdominal Discomfort|Patient's daily assessment of abdominal discomfort using a numerical rating scale of 0 to 10, where 0 = no discomfort at all and 10 = severe discomfort. Higher scores mean a worse outcome.|55 days (baseline, treatment, & follow-up)|All participants who completed the study and had both pre and post treatment abdominal discomfort ratings|||score on a scale||Standard Deviation|Mean
2540140|NCT03055806|Primary|Change From Baseline in Geometric Mean (GM) Intravaginal Ejaculatory Latency Time (IELT) Over the Treatment Assessment Period|Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred and was recorded by the patient or partner using the stopwatch provided.|Last 4 weeks of treatment compared to baseline|Results presented for modified Intent to treat (mITT) population (all randomized participants who took at least 1 dose of study drug and had at least 2 postbaseline nonmissing IELT assessments).|||Seconds||Standard Error|Least Squares Mean
2540141|NCT03055624|Secondary|Change in Prostate Volume (PV)|Change in prostate volume measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates decreased prostate volume and a positive value indicates increased prostate volume.|baseline, 1 month, 6 month|Data was not available for 4 participants|||mL||Standard Deviation|Mean
2540142|NCT03055624|Secondary|Change in International Index of Erectile Dysfunction (IIEF)|IIEF score change from baseline measured at 1 and 6 months. International Index of Erectile Function (IIEF) is a scale grading erectile function based on 5 questions. Questions are answered from 1 (low function) to 5 (high function). Total scores range from 5 to 25. A total score of 5-7 is severe erectile dysfunction, 8 to 11 is moderate erectile dysfunction, 12 to 16 is mild to moderate erectile dysfunction, 17 to 21 is mild erectile dysfunction, and 22-25 is no erectile dysfunction. Change is reported as outcome measure time point minus baseline. A positive value indicates improved erectile function and a negative indicates worsened erectile function.|baseline, 1 month, 6 month|Data was not available for 5 participants|||units on a scale||Standard Deviation|Mean
2540143|NCT03055624|Secondary|Change in Peak Urinary Flow Rate (Qmax)|Change in Qmax measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A positive value indicates improved Qmax and negative value indicates decreased Qmax at each outcome time point.|Baseline, 1 month, 6 month|Data was not available for 4 participants|||mL/sec||Standard Deviation|Mean
2540144|NCT03055624|Secondary|Change in Post-void Residual (PVR) on Ultrasound|PVR (mL) change from baseline measured at 1 and 6 months. Change is reported as outcome measure time point minus baseline. A negative value indicates less post-void residual and a positive value indicates greater PVR at each outcome time point.|baseline, 1 month, 6 month|Data was not available for 4 participants.|||mL||Standard Deviation|Mean
2540145|NCT03055624|Secondary|Change in International Prostate Symptom Score (IPSS)|International Prostate Symptom Score change from baseline measured at 1 and 6 months. The IPSS scale grades lower urinary tract symptoms on a scale ranging from 0 (no symptoms) to 35 (severe). Patients answer 7 questions about symptoms they have had in the past month and grade each symptom severity for each question on a scale from 0 (not at all) to 5 (almost always). Change is reported as outcome measure time point minus baseline. A positive value indicates improved symptoms and negative value worsened symptoms.|baseline, 1 month, 6 month|Data was not available for 1 participant.|||score on a scale||Standard Deviation|Mean
2540146|NCT03055624|Primary|Number of Participants With Adverse Events|The study protocol was terminated before completion as the device was FDA approved and determined to be safe for the treated patient population.|12 months|Patients were assessed for adverse events during the time period the study was open|||Participants|||Count of Participants
2540147|NCT03055494|Secondary|Change in Hemoglobin A1c (HbA1c) Test for Diabetes Score From Baseline to Week 12|"Vital signs: summary statistics for change from baseline to week 12~For people without diabetes, the normal range for the hemoglobin A1c level is between 4% and 5.6%. Hemoglobin A1c levels between 5.7% and 6.4% mean you have a higher chance of getting diabetes. Levels of 6.5% or higher mean you have diabetes."|baseline, week 12|"Safety Set~The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received."|||scores||Standard Deviation|Mean
2540148|NCT03055494|Secondary|Change in Homeostatic Model Assessment of Insulin Resistance (UNIT) (HOMA-IR) From Baseline to Week 12|"Vital signs: summary statistics for change from baseline to Week 12~Healthy Range: 1.0 (0.5-1.4) Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance."|baseline, Week 12|"Safety Set~The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received."|||SI units||Standard Deviation|Mean
2540149|NCT03055494|Secondary|Change in High-sensitivity C-reactive Protein (hsCRP) From Baseline to Week 12|Vital signs: summary statistics for change from baseline to Week 12|baseline, Week 12|"Safety Set~The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received."|||mg/L||Standard Deviation|Mean
2540150|NCT03055494|Secondary|Change in Insulin Level From Baseline to Week 12|Vital signs: summary statistics for change from baseline to Week 12|baseline, Week 12|"Safety Set~The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received."|||pmol/L||Standard Deviation|Mean
2540151|NCT03055494|Secondary|Change in Glucose Level From Baseline to Week 12|Vital signs: summary statistics for change from baseline to Week 12|baseline, Week 12|"Safety Set~The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received."|||mmol/L||Standard Deviation|Mean
2540152|NCT03055494|Secondary|Change in Body Weight From Baseline to Week 12|Vital signs: summary statistics for change from baseline to Week 12|baseline, Week 12|"Safety Set~The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received."|||kg||Standard Deviation|Mean
2540153|NCT03055494|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 12|Vital signs: summary statistics for change from baseline to Week 12|baseline, Week 12|"Safety Set~The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received."|||mmHg||Standard Deviation|Mean
2540154|NCT03055494|Secondary|Change in Systolic Blood Pressure From Baseline to Week 12|Vital signs: summary statistics for change from baseline to Week 12|baseline, Week 12|"Safety Set~The Safety Set includes all patients who received at least 1 dose of study medication. Patients were included in the analysis according to treatment received."|||mmHg||Standard Deviation|Mean
2551298|NCT02819804|Other Pre-specified|The 30 Day Mortality Rate|Number and percentage of patients that die within the first 30 days of initiating treatment.|Up to 30 days|||||||
2540156|NCT03055494|Secondary|Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 52|Response in skin histology/K16 expression to treatment (answered no)|52 weeks|Full Analysis Set (FAS) comprised all patients to assigned study medication. Patients inappropriately randomized (eg, IRT was called in error for randomization of a screen failed patient) were excluded from FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment which they were assigned at randomization.|||Participants|||Count of Participants
2540157|NCT03055494|Primary|Number of and Percentage of Participants Who Achieved Psoriasis Area and Severity Index 90 (PASI 90) at Week 12|Psoriasis Area and Severity Index 90|12 weeks|Full Analysis Set (FAS) comprised all patients to assigned study medication. Patients inappropriately randomized (eg, IRT was called in error for randomization of a screen failed patient) were excluded from FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment which they were assigned at randomization.|||Participants|||Count of Participants
2540158|NCT03055494|Primary|Number and Percentage of Participants With Response of Psoriasis Skin Lesions to Treatment at Week 12|Response in skin histology/K16 expression to treatment (answered no)|12 weeks|Full Analysis Set (FAS) comprised all patients to assigned study medication. Patients inappropriately randomized (eg, IRT was called in error for randomization of a screen failed patient) were excluded from FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment which they were assigned at randomization.|||Participants|||Count of Participants
2540159|NCT03055338|Secondary|Least Squares Mean (LSM) Change From Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 4|The LSM change from baseline at week 4 was assessed for CGI-S score. The CGI-S is a 7-point clinician-rated scale for assessing the global severity of the participant's illness. Possible CGI-S scores range from 1 (participant normal, not ill) to 7 (participant extremely ill). Further, a decrease in CGI-S score indicates reduced severity of the participant's illness.|Baseline and Week 4|Includes all randomized participants who: 1) received ≥1 dose of study treatment; 2) had a baseline CGI-S assessment; and 3) had ≥1 post-randomization observation for CGI-S score subsequent to ≥1 dose of study treatment.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2540160|NCT03055338|Primary|Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event|The percentage of participants discontinuing study treatment due to an AE was assessed. An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to 4 weeks|Includes all randomized and treated participants.|||Percentage of Participants|||Number
2540161|NCT03055338|Primary|Percentage of Participants Experiencing an Adverse Event (AE)|The percentage of participants experiencing an AE was assessed. An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to 6 weeks|Includes all randomized and treated participants.|||Percentage of Participants|||Number
2540162|NCT03055338|Primary|Least Squares Mean (LSM) Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4|The LSM change from baseline at week 4 was assessed for PANSS total score. The PANSS assesses the severity of schizophrenia symptoms through a clinician-rated inventory of 30 items organized in 3 subscales: 1) positive subscale (7 items); 2) negative subscale (7 items); and 3) general psychopathology subscale (16 items). For each item, symptoms are scored from 1 (absent) to 7 (extreme) and sum to a total PANSS score (range: 30-210). Higher scores reflect more severe symptoms of schizophrenia. Further, reduced symptom severity over time is reflected by decreases in score.|Baseline and Week 4|Includes all randomized participants who: 1) received ≥1 dose of study treatment; 2) had a baseline PANSS assessment; and 3) had ≥1 post-randomization observation for PANSS score subsequent to ≥1 dose of study treatment.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2540163|NCT03055260|Secondary|Quadriceps Muscle Thickness|Difference between groups in the measurement of the muscle thickness of the quadriceps muscle via ultrasound.|6 weeks|No participants completed the placebo arm.|||centimeters||Standard Deviation|Mean
2540164|NCT03055260|Primary|One Repetition Maximum|One repetition maximum on the single leg press. Isometric quadriceps extension strength.|6 weeks|No participants completed the placebo arm.|||pounds||Standard Deviation|Mean
2540165|NCT03055221|Primary|Effect of Long-term Remodulin Therapy on the NYHA Functional Classification|The NYHA functional classification ranges from I (subject's disease does not affect daily activities) to IV (subject's disease causes severe impairment).|The NYHA functional classification was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit|Data presented include all subjects who underwent an NYHA functional classification assessment at their final visit. Not all subjects underwent an NYHA assessement at their final visit.|||Functional Class||Standard Deviation|Mean
2540166|NCT03055221|Primary|Effect of Long-term Remodulin Therapy on the 6-Minute Walk Distance (6MWD)|The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living.|The 6MWD was assessed at each subject's last visit, which occurred up to approximately 9 years after first visit|Data are presented for subjects who completed the 6MWT at their final visit. Not all subjects completed a 6MWT at their final visit.|||Meters||Standard Deviation|Mean
2540186|NCT03055195|Secondary|Number of Participants With On-treatment AEs of Special Interest Reported as Local Site Injection Reaction and Systemic Reactions|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with local site injection reaction and systemic reactions were reported.|Up to Week 20|Safety Population. One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Participants|||Count of Participants
2540167|NCT03055195|Secondary|Number of Participants With Any Time Post Baseline Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies Response|Blood samples were collected for the determination of anti-mepolizumab antibodies at the specified visits. The number of participants with anti-mepolizumab binding antibodies and neutralizing antibodies response at Any Time Post Baseline has been presented. Neutralizing antibodies response assay result have been only presented for participants with positive anti-drug antibody assay. Day 1 was considered as Baseline.|Up to Week 20|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Participants|||Count of Participants
2540168|NCT03055195|Secondary|Number of Participants With Abnormal Findings for ECG Parameters|Triplicate 12-lead ECG were obtained to measure ECG parameters. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.|Week 4 and Week 16|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Participants|||Count of Participants
2540169|NCT03055195|Secondary|Number of Participants With Worst Post Baseline PCI Value for Vital Signs|"Blood samples were collected from participants for analysis of following vital signs parameters: DBP, Pulse rate and SBP. PCI ranges were <85 or >160 mmHg for SBP, <45 or >100 mmHg for DBP and < 40 or > 110 beats per minute for Pulse rate. Participants were counted in the worst case category that their value changes to (low, within range or no change, or high), unless there is no change in their category. Participants with vital signs value category To Low and To High were presented. Only those parameters having worst post-Baseline PCI values are presented. Day 1 was considered as Baseline."|Up to Week 20|Safety Population. Only those participants with available data at the specified time points were analyzed. One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Participants|||Count of Participants
2540170|NCT03055195|Secondary|Change From Baseline in Vital Signs: Temperature|Temperature was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Celsius||Standard Deviation|Mean
2540171|NCT03055195|Secondary|Change From Baseline in Vital Signs: Pulse Rate|Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Beats per minute||Standard Deviation|Mean
2540172|NCT03055195|Secondary|Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2540173|NCT03055195|Secondary|Change From Baseline in PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)|Triplicate 12-lead electrocardiograms (ECG) were obtained to measure PR Interval, QRS Duration, QT Interval and QTcF Interval. Screening was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Screening) and Weeks 4, 16|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Milliseconds||Standard Deviation|Mean
2540174|NCT03055195|Secondary|Number of Participants With Worst Post Baseline PCI Value for Chemistry Parameters|"Blood samples were collected from participants for analysis of following clinical chemistry parameters: ALT, Calcium, glucose, Potassium and sodium. PCI ranges were >143 units per liter (U/L) for ALT (Age category: 3-12 years) and >239 U/L for ALT (Age category: 13+ years), <1.50 or >3.24 mmol/L for calcium, < 2.2 or > 27.8 mmol/L for glucose, <2.8 or >6.5 mmoL/L for potassium , and <120 or >160 mmoL/L for sodium. Participants were counted in the worst case category that their value changes to (low, normal , or high), unless there is no change in their category. Participants whose laboratory value category was unchanged (e.g., High to High), or whose value became within range, were recorded in the To within Range or No Change category. Only those parameters having worst post-Baseline PCI values were presented. Day 1 was considered as Baseline."|Up to Week 16|Safety Population. Only those participants with available data at the specified time points were analyzed. One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Participants|||Count of Participants
2540185|NCT03055195|Secondary|Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets|Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Billion cells per liter (10^9/L)||Standard Deviation|Mean
2551400|NCT02818777|Primary|Number of Participants Had Changes in Orthostatic Blood Pressure|Orthostatic blood pressure will be monitored at each study visit.|Baseline and 5 weeks||||Participants|||Count of Participants
2540175|NCT03055195|Secondary|Number of Participants With Worst Post Baseline Potential Clinical Importance (PCI) Value for Hematology Parameters|"Blood samples were collected from participants for analysis of following hematology parameters; hematocrit, hemoglobin, leukocytes and platelets. PCI ranges were < 0.201 or >0.599 proportion of red blood cells in blood for hematocrit, <71 or >199 grams per liter for hemoglobin, <31 or >1499 Giga cells per liter for platelets and for leukocytes < 1.1 Giga cells per liter. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants with laboratory value category To Low and To High were presented. Only those parameters having worst post-Baseline PCI values were presented. Day 1 was considered as Baseline."|Up to Week 20|Safety Population. Only those participants with available data at the specified time points were analyzed. One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Participants|||Count of Participants
2540176|NCT03055195|Secondary|Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Urea|Blood samples were collected to analyze the chemistry parameters: Calcium, Glucose, Potassium, Sodium and Urea. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 1) and Weeks 4, 8, 12, and 16|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2540177|NCT03055195|Secondary|Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin|Blood samples were collected to analyze the chemistry parameters: Bilirubin, Creatinine and Direct Bilirubin. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 1) and Weeks 4, 8, 12, and 16|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Micromoles per liter||Standard Deviation|Mean
2540178|NCT03055195|Secondary|Change From Baseline in Chemistry Parameters: Albumin and Protein|Blood samples were collected to analyze the chemistry parameters: Albumin and Protein. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 1) and Weeks 4, 8, 12, and 16|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Grams per liter||Standard Deviation|Mean
2540179|NCT03055195|Secondary|Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST)|Blood samples were collected to analyze the chemistry parameters: ALT, ALP and AST . Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 1) and Weeks 4, 8, 12, and 16|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||International units per liter (IU/L)||Standard Deviation|Mean
2540180|NCT03055195|Secondary|Change From Baseline in Hematology Parameter: Hemoglobin|Blood samples were collected to analyze the hematology parameter: Hemoglobin. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Grams per liter||Standard Deviation|Mean
2540181|NCT03055195|Secondary|Change From Baseline in Hematology Parameter: Hematocrit|Blood samples were collected to analyze the hematology parameter: Hematocrit. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Percentage of red blood cells in blood||Standard Deviation|Mean
2540182|NCT03055195|Secondary|Change From Baseline in Hematology Parameter: Erythrocytes|Blood samples were collected to analyze the hematology parameter: Erythrocytes. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Trillion cells/liter (10^12 cell/L)||Standard Deviation|Mean
2540183|NCT03055195|Secondary|Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume|Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Femtoliter||Standard Deviation|Mean
2540184|NCT03055195|Secondary|Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin|Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Picograms||Standard Deviation|Mean
2540275|NCT03053427|Secondary|Change From Baseline in Restless Legs Syndrome (RLS) Pain Score|The scale range of RLS pain score was 0-10. Higher scores represent greater RLS pain intensity. ANCOVA model with the baseline value as a covariate was used.|Baseline and EoT (week 12)|FAS.|||units on a scale||95% Confidence Interval|Least Squares Mean
2540187|NCT03055195|Secondary|Number of Participants With On-treatment Adverse Events (AEs), Serious Adverse Events (SAEs) and Non-serious Adverse Events (nSAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. On-treatment AES were reported on or after treatment start date and on or before treatment stop date (plus 28 days). Number of participants with AEs, SAEs and nSAEs is presented.|Up to Week 20|Safety Population comprised of all participants who received at least one dose of a study treatment. One participant from Placebo arm received Mepolizumab at Day 1 instead of placebo due to error.|||Participants|||Count of Participants
2540188|NCT03055195|Secondary|Number of Participants With an IGA Score of 0 or 1 and at Least a 2-grade Improvement at Each Study Visit|The IGA is a clinical tool for assessing the current state/severity of a participant's atopic dermatitis . It is a static 5-point morphological assessment of overall disease severity determined by the investigator, sub-investigator, or trained healthcare professional with required qualifications on a scale of 0 to 4 where, 0-clear, 1-almost clear, 2-mild, 3-moderate, and 4- severe. Higher score indicates severity of disease. A Responder is defined as a participant who had an IGA score of 0 or 1 and a minimum 2-grade improvement from Baseline. Participants withdrawn early from the study were assigned to be a non-responder for all weeks after withdrawal. Number of participants with IGA score of 0 or 1 and at least a 2- grade improvement at each study visit (Weeks 4, 8, 12, 16 and 20) is presented.|Weeks 4, 8, 12, 16 and 20|Intent-to-Treat Population|||Participants|||Count of Participants
2540189|NCT03055195|Secondary|Mean Percentage Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Study Visit|EASI scoring system is a standardized clinical tool for the assessment of atopic dermatitis that takes into account overall extent of the percent body surface area (% BSA) involved and severity scores for each clinical signs (erythema, induration/papulation, excoriation, and lichenification). Severity scores were graded on a 4-point scale, 0(absent) to 3(severe) for each body regions (head and neck, upper extremities, lower extremities, and trunk). The severity scores for each signs were summed for each region and multiplied by the % BSA area score and by the appropriate proportionality multiplier (for participants >=8 years of age, 0.1 for head, 0.2 upper extremities, 0.3 for trunk and 0.4 for lower extremities) to generate a regional EASI score. The regional EASI scores were then summed to yield the final EASI score. Baseline is defined as latest pre-dose assessment. Percent change from Baseline is Post-Baseline Visit Value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20|Intent-to-Treat Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent change||Standard Deviation|Mean
2540190|NCT03055195|Primary|Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and at Least a 2- Grade Improvement at Week 16|The IGA is a clinical tool for assessing the current state/severity of a participant's atopic dermatitis . It is a static 5-point morphological assessment of overall disease severity determined by the investigator, sub-investigator, or trained healthcare professional with required qualifications on a scale of 0 to 4 where, 0-clear, 1-almost clear, 2-mild, 3-moderate, and 4- severe. Higher score indicates severity of disease. A responder is defined as a participant who had an IGA score of 0 or 1 and a minimum 2-grade improvement from Baseline. Number of participants with IGA score of 0 or 1 and at least a 2- grade improvement at Week 16 was presented.|Week 16|Intent-to-Treat Population comprised of all participants who were randomized and who received at least one dose of study treatment.|||Participants|||Count of Participants
2540191|NCT03054922|Secondary|Change in pH|Change in pH from 1st to 2nd blood gas|During surgery (typically 4-6 hrs in length)||||units on a scale||Standard Deviation|Mean
2540192|NCT03054922|Secondary|Change in Ionized Calcium|Change in calcium electrolyte from 1st to 2nd blood gas|During surgery (typically 4-6 hrs in length)||||mEq/L||Standard Deviation|Mean
2540193|NCT03054922|Secondary|Change in Potassium|Change in potassium electrolyte from 1st to 2nd blood gas|During surgery (typically 4-6 hrs in length)||||mEq/L||Standard Deviation|Mean
2540194|NCT03054922|Secondary|Change in Sodium|Change in sodium electrolyte from 1st to 2nd blood gas|During surgery (typically 4-6 hrs in length)||||mEq/L||Standard Deviation|Mean
2540195|NCT03054922|Primary|Change in Base Deficit|Change in base deficit from 1st to 2nd blood gas to measure metabolic acidosis|During surgery (typically 4-6 hrs in length)||||mEq/L||Standard Deviation|Mean
2540196|NCT03054857|Secondary|ICU Stay in Hours||7 days||||hours||Standard Deviation|Mean
2540197|NCT03054857|Secondary|Hospital Stay in Days||30 days||||days||Standard Deviation|Mean
2540198|NCT03054857|Secondary|Number of Participants With Postoperative Complications|Neurological complication, Delirium, dysrhythmia, death|7 days||||Participants|||Count of Participants
2540199|NCT03054857|Primary|Number of Participants With Postoperative Cognitive Dysfunction (POCD)|POCD was defined as a decline of 1SD of baseline score in either MoCA test or short bless test.|7 days||||Participants|||Count of Participants
2540200|NCT03054857|Primary|Numbers of Participants With Postoperative Cognitive Dysfunction (POCD)|POCD was defined as a decline of 1 standard-deviation (1SD) of baseline score in either MoCA test or short bless test.|48 hours||||Participants|||Count of Participants
2540201|NCT03054844|Secondary|Provider Satisfaction|I would like to use this method of administering intranasal midazolam and lidocaine again in the future|1 minute||||Participants|||Count of Participants
2540202|NCT03054844|Secondary|Parental Satisfaction|If my child needed medications to stay calm for a procedure, I would like to use these same medications again.|1 minute||||Participants|||Count of Participants
2540203|NCT03054844|Secondary|Procedural Distress, Cry Duration|Cry duration was measured in seconds and defined as the time from onset of crying following administration of an IN medication until the cessation of crying sounds and/or tears. If a patient did not cry, the cry duration was zero|10 minutes||||seconds||95% Confidence Interval|Mean
2540495|NCT03046212|Secondary|Change in Hip Range of Motion From Baseline to 45 Minutes|Flexion and abduction movements were assessed by goniometry in the hip submitted to the surgery. Two evaluations were performed in each group, before and after the interventions.|baseline, 45 minutes||||degrees||Standard Deviation|Mean
2540205|NCT03054844|Secondary|Procedural Pain|The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) utilizes six observational factors (cry, facial, verbal, torso, touch, and legs) to evaluate pain in young children and can be used to monitor the effectiveness of interventions for reducing the pain and discomfort of an intervention. This scale rates each behavior numerically, with a score of 4-6 units on a scale representing no pain, and a maximum score of 13 units on a scale representing (most pain perceived).|10 minutes||||Units on a scale||95% Confidence Interval|Mean
2540206|NCT03054844|Primary|Procedural Distress, OSBD-R|The Observational Scale of Behavioral Distress-Revised (OSBD-R) is an observational measure of pain and distress shown to have strong validity in children. The scale is an 8-factor, weighted observational scale used to measure distress associated with medical procedures, which has been validated in children and adults aged 1 to 20 years. The total Observational Scale of Behavioral Distress-Revised score is the sum of the scale scores for each phase, with each phase assigned a score from 0 to 23.5 units on a scale (0=no distress, 23.5=maximum distress), based on the frequency and types of behaviors observed during a predetermined number of 15-second intervals during each phase. There were four phases so the range of scores for the total OSBD-R was 0 to 94 units on a scale, with a higher score indicated a greater degree of distress.|10 minutes||||Units on a scale||95% Confidence Interval|Mean
2540207|NCT03054805|Primary|Change of Clostridium Butyricum Miyairi Expression After Probiotics Supplementation in Constipated Children.|The expression of Clostridium butyricum Miyairi (CBM) in constipated children feces means a better outcome measure.|Change from baseline Clostridium butyricum Miyairi expression at 3 months.||||number of bacteria per mg of feces||Standard Deviation|Mean
2540208|NCT03054740|Secondary|Would Patient Choose to Have Intervention Again if IV Catheter Insertion is Needed|Yes or No question|less than 10 minutes following spray application||||Participants|||Count of Participants
2540209|NCT03054740|Secondary|Using the Same Visual Analog Scale Rate Pain the Last Time the Patient Remembers Having an IV Inserted|Visual Analog Scale 0 no pain, 1-2 mild, 3-5 moderate, 6 severe, 7-8 very severe, 9-10 worst possible pain|At baseline prior to spray application||||score on a scale||Standard Deviation|Mean
2540210|NCT03054740|Secondary|Using the Same Likert Scale Rate How Satisfied the Patient Remembers the Last Time They Had IV Catheter Inserted|"1-5 Likert Scale~1 very dissatisfied, 2 somewhat dissatisfied, 3 neither satisfied or dissatisfied, 4 somewhat satisfied, 5 very satisfied"|At baseline prior to spray application||||Participants|||Count of Participants
2540211|NCT03054740|Secondary|Satisfaction Scale Using 1-5 Likert Scale|1-Very Satisfied; 2-Somewhat Satisfied; 3-Neither Satisfied or Dissatisfied; 4-Somewhat Satisfied; 5-Very Satisfied|less than 5 minutes following spray application||||Participants|||Count of Participants
2540212|NCT03054740|Primary|Pain Scale Using Visual Analog Scale|0-No Pain; 1-3 Mild Pain; 4-6 Moderate-Severe Pain; 7-9 Very Severe Pain;10 Worst Possible Pain|less than 5 minutes following spray application||||score on a scale||Standard Deviation|Mean
2540213|NCT03054506|Secondary|Spontaneous Bowel Movement (SBM) Frequency|Average number of Spontaneous Bowel Movements per day. (Spontaneous Bowel Movements include both complete and incomplete bowel movements)|55 days (baseline, treatment, & follow-up)|All participants who completed the study and had both pre and post treatment SBM measurements|||number of SBMs per day||Standard Deviation|Mean
2540214|NCT03054506|Secondary|Need for Rescue Laxatives|"Number of total days that rescue laxatives were used by participants in each treatment group.~(The number of days that rescue laxatives were used by each individual patient was calculated and added to the treatment group total)"|55 days (baseline, treatment, & follow-up)|All participants who completed the study and had daily medication usage data|||days|||Number
2540215|NCT03054506|Secondary|Patient Assessment of Constipation - Quality of Life (PAC-QOL)|"Patient Assessment of Constipation Quality of Life Questionnaire. A validated questionnaire containing 28 total questions with four sub-sections each broadly ranging from not at all to all of the time on 0 to 4 scales.~Possible total range is 0 to 112. An overall higher total score on the PAC-QOL means a worse outcome. PAC-QOL was completed at four time-points (Day -14, Day 0, Day 15, & Day 22). Scores were aggregated based on time period as either pre- (Day -14 & Day 0) or post- (Day 15 & Day 22) treatment start. Values reported are averages based on patient total scores from these time points. Data was specifically analyzed based on patient diagnosis in addition to treatment."|Day -14 to Day 22|All participants who completed the study and had both pre and post treatment PAC-QOL ratings|||score on a scale||Standard Deviation|Mean
2540216|NCT03054506|Secondary|Patient Assessment of Constipation - Symptoms (PAC-SYM)|"Patient assessment of constipation symptom severity questionnaire. A validated 12-question questionnaire.~Numerical scale from 0 to 4 where 0 = absent and 4 = very severe. Possible total score ranges from 0 to 48. Higher total PAC-SYM scores mean a worse outcome.~PAC-SYM was completed at four time-points (Day -14, Day 0, Day 15, & Day 22). Scores were aggregated based on time period as either pre- (Day -14 & Day 0) or post- (Day 15 & Day 22) treatment start. Values reported are averages based on patient total scores from these time points. Data was specifically analyzed based on patient diagnosis in addition to treatment."|Day -14 to Day 22|All participants who completed the study and had both pre and post treatment PAC-SYM ratings|||score on a scale||Standard Deviation|Mean
2540217|NCT03054506|Secondary|Relief Rating|Patient's feeling of overall relief after each bowel movement using a numerical rating scale from 0 to 10 where 0 = no relief and 10 = complete relief. Higher scores mean a better outcome (feeling more relief after a bowel movement).|55 days (baseline, treatment, & follow-up)|All participants who completed the study and had both pre and post treatment relief ratings|||score on a scale||Standard Deviation|Mean
2540218|NCT03054506|Secondary|Patient Assessment of Constipation Severity|Patient's daily assessment of constipation severity using a numerical rating scale from 0 to 10 where 0 = no constipation at all and 10 = severe constipation. Higher numbers mean a worse outcome.|55 days (baseline, treatment, & follow-up)|All participants who completed the study and had both pre and post treatment constipation severity ratings|||score on a scale||Standard Deviation|Mean
2540219|NCT03054506|Secondary|Patient Assessment of Bloating Severity|Patient's daily assessment of bloating severity using a numerical rating scale from 0 to 10 where 0 = no bloating at all and 10 = severe bloating. Higher scores mean a worse outcome.|55 days (baseline, treatment, & follow-up)|All participants who completed the study and had both pre and post treatment bloating ratings.|||score on a scale||Standard Deviation|Mean
2551608|NCT02813577|Secondary|Number of Participants With Target Vessel Revascularization (TVR) at 1, 6, 12, and 24 Months Post Index Porcedure||1, 6, 12 and 24 months post index procedure|Study was terminated.||||||
2540221|NCT03054506|Secondary|Ease of Passage Rating|"Patient assessment of the ease with which bowel movements are passed using a descriptive numerical scale where lower numbers indicate difficult passage of stool, numbers toward the middle indicate more normal passage of stool, and numbers on the highest end indicate abnormally urgent passage of stool. Middle scores indicate a better outcome.~= manual disimpaction needed~= enema needed~= straining needed~= normal~= urgent without pain~= urgent with pain~= incontinent"|55 days (baseline, treatment, & follow-up)|All participants who completed the study and had both pre and post treatment ease of passage ratings|||score on a scale||Standard Deviation|Mean
2540222|NCT03054506|Secondary|Stool Consistency|"Stool consistency for each bowel movement based on the Bristol Stool Scale A descriptive numerical scale from 1 to 7 where lower numbers indicate constipation, numbers toward the middle indicate normal stool consistence, and the highest numbers indicate diarrhea. Therefore middle scores mean a better outcome~1= hard lumps 2 = lumpy sausage 3 = cracked sausage 4 = smooth sausage 5 = soft lumps 6 = mushy 7 = watery"|55 days (baseline, treatment, & follow-up)|All participants who completed the study and had both pre and post treatment stool consistency ratings.|||score on a scale||Standard Deviation|Mean
2540223|NCT03054506|Secondary|Complete Spontaneous Bowel Movement (CSBM) Frequency Rate|Average number of Complete Spontaneous Bowel Movements per day (BMs where participant felt that they emptied their bowels). More CSBMs are interpreted as a better outcome.|55 days (baseline, treatment, & follow-up)|All participants who completed the study and had both pre and post treatment CSBM measurement|||number of CSBMs per day||Standard Deviation|Mean
2540224|NCT03054506|Primary|Change From Baseline in Colonic Transit Time (CTT)|Colonic Transit Time is the amount of time (in minutes) that the SmartPill capsule spent in the large intestine before expulsion. We measured the difference between CTT pre-treatment and post-treatment and calculated the mean difference for each treatment group. Negative values equal a reduction in CTT.|Up to 1 week; measured once during the run-in-period and again during third week of the treatment period|All participants who completed the study. (39 participants) Note: One participant who received placebo had pre-treatment CTT data, but post-treatment CTT data was irretrievable due to technical malfunction. This subject's pre-treatment CTT data is included in analysis, but no post-treatment CTT data.|||minutes||Standard Deviation|Mean
2540225|NCT03054428|Secondary|Percentage of Participants With Serious TEAEs Through Week 16|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study (Week 28)). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline through Week 16|Analysis was performed on FAS population (all randomized participants). Here, number of participants analyzed = participants with available data for this endpoint.|||Percentage of participants|||Number
2540226|NCT03054428|Secondary|Percentage of Participants With Skin-infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Through Week 16|Any untoward medical occurrence in a subject who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study (Week 16)). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline through Week 16|Analysis was performed on FAS population (all randomized participants). Here, number of participants analyzed = participants with available data for this endpoint.|||Percentage of participants|||Number
2540227|NCT03054428|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline at Week 4|"Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question for maximum itch intensity: On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours? For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. For example, if there were 3 scores in a week, the prorated average = (score1 + score2 + score3)/ 3."|Baseline and Week 4|Analysis was performed on FAS population (all randomized participants).|||Percentage of participants|||Number
2540228|NCT03054428|Secondary|Change From Baseline in Total Hospital Anxiety and Depression Scale (HADS) at Week 16|The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each item is rated on a 4-point scale (0-3). A person could score between 0 & 21 for each subscale (anxiety & depression). A high score is indicative of a poor state. Scores of 11 or more on either subscale are considered a 'definite case' of psychological morbidity, while scores of 8 to 10 represents 'probable case' & 0 to 7 'not a case'. The total score was the sum of the 2 sub-scores; therefore, the full range of possible values for the reported data is 0-42.|Baseline and Week 16|Analysis was performed on FAS population (all randomized participants).|||Scores on a scale||Standard Error|Least Squares Mean
2540229|NCT03054428|Secondary|Percent Change From Baseline in Weekly Average of Daily Peak Pruritus NRS at Week 4|"Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question for maximum itch intensity: On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours? For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. For example, if there were 3 scores in a week, the prorated average = (score1 + score2 + score3)/ 3."|Baseline and Week 4|Analysis was performed on FAS population (all randomized participants).|||Percent change||Standard Error|Least Squares Mean
2552320|NCT02796092|Secondary|Procedure Radiation Dose (DAP)|DAP, dose area product of the intervention, (in mGy*cm^2), recorded by fluoroscopy equipment|Intraoperative||||mGy*cm^2||Standard Deviation|Mean
2540230|NCT03054428|Secondary|Change From Baseline in Weekly Average of Daily Peak Pruritus NRS at Week 16|"Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Particpants were asked the following question for maximum itch intensity: On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours? For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. For example, if there were 3 scores in a week, the prorated average = (score1 + score2 + score3)/ 3."|Baseline and Week 16|Analysis was performed on FAS population (all randomized participants).|||Scores on a scale||Standard Error|Least Squares Mean
2540231|NCT03054428|Secondary|Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16|The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults with atopic eczema. The format is subject response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on symptom frequency during the past week (ie, 0 = 'no days', 1 = '1 to 2 days', 2 = '3 to 4 days', 3 = '5 to 6' days, and 4 = 'every day'). The total score is the sum of the 7 items which is ranged from 0 to 28; a high score is indicative of a poor quality of life (QOL).|Baseline and Week 16|Analysis was performed on FAS population (all randomized participants).|||Scores on a scale||Standard Error|Least Squares Mean
2540232|NCT03054428|Secondary|Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Total Score at Week 16|The CDLQI is a 10-item questionnaire used to measure how much a participant's skin problem had affected the participant's quality of life (QOL) over a recall period of the past week. The questionnaire consists of 10 items. For each item the scale is rated as follows: 0 = Not at all = Not relevant; 1 = Only a little; 2 = Quite a lot; 3 = Very much = Yes = Prevents school. The CDLQI total score is the sum of the score of each question with a maximum of 30 and a minimum of 0. The higher the score, the greater the impact is on the QOL.|Baseline and Week 16|Analysis was performed on FAS population (all randomized participants).|||Scores on a scale||Standard Error|Least Squares Mean
2540233|NCT03054428|Secondary|Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16|The SCORAD index is a clinical tool for assessing the severity of atopic dermatitis. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).|Baseline and Week 16|Analysis was performed on FAS population (all randomized participants).|||Percent change||Standard Error|Least Squares Mean
2540234|NCT03054428|Secondary|Change From Baseline in Percent Body Surface Area (BSA) at Week 16|BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.|Baseline and Week 16|Analysis was performed on FAS population (all randomized participants).|||Percentage of body surface area||Standard Error|Least Squares Mean
2540235|NCT03054428|Secondary|Time to Onset of Effect on Pruritus as Measured by Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline|"Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours? [For this endpoint, subjects achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were counted as non-responders.]"|Baseline up to Week 16|Analysis was performed on FAS population (all randomized participants). Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.|||Percentage of participants||Standard Deviation|Mean
2540236|NCT03054428|Secondary|Time to Onset of Effect on Pruritus as Measured by Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline|"Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours? [For this endpoint, participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were counted as non-responders.]"|Baseline up to week 16|Analysis was performed on FAS population (all randomized participants). Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥3.|||Percentage of participants||Standard Deviation|Mean
2540237|NCT03054428|Secondary|Percentage of Participants With EASI-90 (≥90% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-90 responders were the participants who achieved ≥90% overall improvement in EASI score at Week 16. [Values after first rescue treatment used were set to missing. Participants with missing value at week 16 were considered as a non-responder.]|Baeline and Week 16|Analysis was performed on FAS population (all randomized participants).|||Percentage of participants|||Number
2540238|NCT03054428|Secondary|Percentage of Participants With EASI-50 (≥50% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score at Week 16. [Values after first rescue treatment used were set to missing. Participants with missing value at Week 16 were considered as a non-responder].|Baseline and Week 16|Analysis was performed on FAS population (all randomized participants).|||Percentage of participants|||Number
2540871|NCT03039621|Secondary|Time to Alleviation of Flu-like Nonspecific Symptoms.|Based on patient diary data. Absence of flu-like nonspecific symptoms/presence of one mild flu-like nonspecific symptom.|14 days of observation.|ITT sample|||days||95% Confidence Interval|Mean
2540239|NCT03054428|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline to Week 16|"Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours? [For this endpoint, participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were counted as non-responders.]"|Baseline to Week 16|Analysis was performed on FAS population (all randomized participants). Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.|||Percentage of participants|||Number
2540240|NCT03054428|Secondary|Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Daily Peak Pruritus NRS From Baseline to Week 16|"Peak Pruritus NRS is an assessment tool used by participants to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours? [For this endpoint, participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were counted as non-responders.]"|Baseline to Week 16|Analysis was performed on FAS population (all randomized participants). Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥3.|||Percentage of participants|||Number
2540241|NCT03054428|Secondary|Percent Change From Baseline in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score at Week 16|"Peak Pruritus NRS is an assessment tool used by subjects to report intensity of pruritus (itch) during a 24-hour recall period. Participants were asked the following question: For maximum itch intensity: On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours? For post-baseline NRS, the mean weekly NRS was calculated as the prorated average of the reported daily NRS within the week. For example, if there were 3 scores in a week, the prorated average = (score1 + score2 + score3) /3. [Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were counted as non-responders.]"|Baseline and Week 16|Analysis was performed on FAS population (all randomized participants).|||Percent change||Standard Error|Least Squares Mean
2540242|NCT03054428|Secondary|Percent Change From Baseline in EASI Score at Week 16|The Eczema Area and Severity Index (EASI) score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. [Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.]|Baseline and Week 16|Analysis was performed on FAS population (all randomized participants).|||Percent change||Standard Error|Least Squares Mean
2540243|NCT03054428|Primary|Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (≥75% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of AD and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI--75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16. [Values after first rescue treatment used were set to missing. Participants with missing score at week 16 were considered as a non-responder. Participant considered nonresponder after rescue treatment use. Efficacy analyses were based on the treatment allocated at randomization (as randomized).]|Baseline and Week 16|Analysis was performed on Full Analysis Set (FAS) population (all randomized participants).|||Percentage of participants|||Number
2540244|NCT03054428|Primary|Percentage of Participants With Investigator's Global Assessment (IGA) 0 or 1 (and Reduction From Baseline of ≥2 Points) at Week 16|"IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA 0 or 1 and a reduction from baseline of ≥2 points at Week 16 were reported. [Values after first rescue treatment used were set to missing. Participants with missing score at week 16 were considered as a non-responder. Participant considered non-responder after rescue treatment use. Efficacy analyses were based on the treatment allocated at randomization (as randomized).]"|Baseline and Week 16|Analysis was performed on Full Analysis Set (FAS) population (all randomized participants).|||Percentage of participants|||Number
2540245|NCT03054103|Secondary|Nausea|Self-reported incidence of nausea. This will be assessed by asking the subjects once (just prior to discharge from the PACU) whether they experienced any nausea while they were in the PACU (Recovery Room) and will be a measurement of the count of participants that experienced nausea during this period|This will occur from time of entry into PACU to time of departure after their surgery. (One time only, in a range of 20 to 30 minutes after surgery.||||Participants|||Count of Participants
2540246|NCT03054103|Secondary|PACU Length of Stay|This is obtained from the records as time spent in the PACU (Recovery Room) after surgery.|This will occur one time only, in a range of 20 to 30 minutes after the surgery is completed.||||Minutes||Standard Deviation|Mean
2540247|NCT03054103|Secondary|Measure of Comfort (See Link to Study Protocol for Scale)|Measure of comfort (0-3; 0=very comfortable to 3=extremely uncomfortable|Obtained on the first day after surgery during the subject's routine postoperative check in the Ophthalmology Clinic.||||units on a scale||Standard Deviation|Mean
2540248|NCT03054103|Primary|Eye Mobility During Surgery (See Link to Study Protocol for Scale)|Scale of mobility of eye during surgery rate 0 (no movement) to 3 (movement enough to stop surgery).|Intraoperative, end of operation reported||||units on a scale||Standard Deviation|Mean
2540872|NCT03039621|Secondary|Time to Normalization of Body Temperature.|Based on patient diary data. Oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period).|14 days of observation.|ITT sample|||days||95% Confidence Interval|Mean
2540249|NCT03054077|Primary|Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2|"The Modified Yale Preoperative Anxiety Scale- Short form (mYPAS-SF) Ratings produce 4 mYPAS scores (1 for each time point)~Areas scored:~Activity (1,2,3, or 4) Vocalizations (1,2,3,4,5,or 6) Emotional Expressivity (1,2,3, or 4) State of Apparent arousal (1,2,3, or 4) Scoring: Each score is calculated by dividing each item rating by the highest possible rating (i.e., 6 for the vocalizations item and 4 for all other items), adding all the produced values, dividing by 5, and multiplying by 100.~This calculation produces a score ranging from 23.33 to 100, with higher values indicating higher anxiety.~Comparison of scores between Group 1 and Group 2 to see if changes in anxiety scores occurred with the addition of the iPad.~All data will be gathered with review at the close of the study which is anticipated to occur in 5/20/2017."|Immediately following enrollment, immediately before anesthesia, and post-op assessed up to 10 minutes|All participants for whom 3 time points were collected at Baseline T1, T2, and T3|||units on a scale||95% Confidence Interval|Least Squares Mean
2540250|NCT03054064|Secondary|Pain Measured With Face, Legs, Activity, Cry, Consolability Scale|"Pain measured with Face, Legs, Activity, Cry, Consolability (FLACC) Scale Face 0: no particular expression or smile~occasional grimace or frown, withdrawn, disinterested~frequent to constant frown, clenched jaw, quivering chin~Legs 0: normal position or relaxed~uneasy, restless, tense~kicking, or legs drawn up~Activity 0: lying quietly, normal position, moves easily~squirming, shifting back and forth, tense~arched, rigid, or jerking~Cry 0: no cry (awake or asleep)~moans or whimpers, occasional complaint~crying steadily, screams or sobs, frequent complaints~Consolability 0: content, relaxed~reassured by occasional touching, hugging, or being talked to, distractable~difficult to console or comfort~Minimum score: 0 Maximum Score: 10"|2 weeks||||units on a scale||Standard Deviation|Mean
2540251|NCT03054064|Secondary|Gait Speed (Without Indego) Measured With 10 Meter Walk Test|10 Meter Walk Test (MWT) without Indego to measure gait speed|2 weeks||||seconds||Standard Deviation|Mean
2540252|NCT03054064|Secondary|Activity Measured by Functional Ambulation Category|"Activity measured by Functional Ambulation Category (FAC)~unable to ambulate/ambulates only in parallel bars/requires supervision or physical assistance from > 1 person~requires manual contact of one person during ambulation on level surfaces/manual contact is continuous and necessary to support body weight and/or to maintain balance or assist coordination~requires manual contact of one person during ambulation on level surfaces/manual contact is continuous or intermittent light touch to assist balance or coordination~ambulation occurs on level surfaces without manual contact of another person/requires stand-by guarding of one person because of poor judgment, questionable cardiac status, or the need for verbal cuing to complete the task~ambulation is independent on level surfaces/requires supervision/physical assistance to negotiate stairs, inclines, or unlevel surfaces~ambulation is independent on unlevel and level surfaces, stairs and inclines"|2 weeks||||units on a scale||Standard Deviation|Mean
2540253|NCT03054064|Secondary|Spasticity of Bilateral Upper Extremities (UE) and Lower Extremities (LE) Measured With Modified Ashworth Scale|"Spasticity measured with Modified Ashworth Scale (MAS)~0 - No increase in muscle tone~1 - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension~1+ - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM) 2 - More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3 - Considerable increase in muscle tone, passive movement difficult 4 - Affected part(s) rigid in flexion or extension"|2 weeks||||units on a scale||Standard Deviation|Mean
2540254|NCT03054064|Primary|Safety of Individuals With Hemiplegia Due to CVA Using the Indego Measured Through Reported Subject Adverse Events and Serious Adverse Events|Safety of individuals with hemiplegia due to CVA using the Indego measured through reported Subject Adverse Events and Serious Adverse Events|2 weeks||||Events|||Number
2540255|NCT03054051|Secondary|Change in Attitudes|Attitudes were assessed via 3-pt Likert survey questions relating to HIV stigma, condoms, sex, gender, and future orientation. Attitudes were assessed with 15 items and responses coded as 0, 0.5, or 1. Total scores ranged from 0 to 15, with higher scores indicating more desirable attitudes. A positive value for the change from baseline score indicates an increase in desirable attitudes.|Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention|One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.|||score on a scale||Standard Deviation|Mean
2540256|NCT03054051|Secondary|Change in Perceived Social Norms|Perceived social norms were assessed via a 3-point Likert and addressed sex, gender, condoms, and HIV stigma. Social norms were assessed with 6 items that are scored as 0, 0.5, or 1. Total scores range from 0 to 6 with higher scores indicating perception of more desirable social norms. A positive value for the change from baseline scores indicates a desirable change.|Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention|One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.|||score on a scale||Standard Deviation|Mean
2540257|NCT03054051|Secondary|Change in Future Orientation|Future orientation was assessed via a single multiple-choice question (Yes/No/Maybe) and addressed perceived locus of control. Response is coded as 0, 0.5, or 1 and higher scores indicate greater understanding of future locus of control. A positive value for the change from baseline score indicates a desirable change in scores.|Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention|One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.|||score on a scale||Standard Deviation|Mean
2540258|NCT03054051|Secondary|Change in Behavioral Intention|Behavioral intention was assessed via Yes/No questions. The measure addressed intention to seek advice, to avoid risk situations, and to engage in health protective behaviors. Behavioral intention is assessed with 6 items that are scored as 0 or 1 and total scores range from 0 to 6. Higher scores in indicate more intention to partake in health protective behaviors and a positive value for the change from baseline score indicates a desirable change in intention.|Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention|One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.|||score on a scale||Standard Deviation|Mean
2552321|NCT02796092|Secondary|Fluoroscopy Time|Total fluoroscopy time, recorded by the equipment (in minutes)|Intraoperative||||minutes||Standard Deviation|Mean
2540259|NCT03054051|Secondary|Change in Risk Assessment|Risk assessment was assessed via a 3-point Likert scale, and addressed perceived risk of certain risk situations/behaviors and of contracting HIV. Risk is assessed with 4 items and responses are coded as 0, 0.5 or 1. Total scores range from 0 to 4, with higher scores indicating increased risk assessment. A positive value for the change from baseline score indicates an increase in assessing risky situations as risky.|Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention|One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.|||score on a scale||Standard Deviation|Mean
2540260|NCT03054051|Secondary|Change in Self-Efficacy|Self-efficacy was assessed via a 3-point Likert scale, and addressed self-efficacy to seek advice about puberty, sex, relationships; to communicate about protected sex; to reject peer, partner and adult pressure to engage in risk behaviors. Self-efficacy was assessed with 9 items which were scored as 0, 0.5 or 1. Total scores ranged from 0 to 9, with higher scores indicating increased self-efficacy. A positive value for the change from baseline score indicates an increase in self-efficacy since the baseline assessment.|Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention|One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.|||score on a scale||Standard Deviation|Mean
2540261|NCT03054051|Secondary|Change in Knowledge|Knowledge measures will be assessed via Yes/No survey questions and will address puberty, HIV, sexually transmitted infections (STIs), pregnancy, condoms, and alcohol and drugs. Knowledge was assessed with 15 items and responses are coded as 0 or 1. Total scores range from 0 to 15, with higher scores indicating increased knowledge. A positive value for the change from baseline score indicates an increase in knowledge from the baseline assessment.|Baseline, Day 17 (post-intervention), 6 Weeks Post-intervention|One participant from the intervention arm was removed from this analysis at the immediate post-intervention time point due to delayed completion of the post-intervention survey.|||score on a scale||Standard Deviation|Mean
2540262|NCT03054051|Primary|Number of Participants Playing the Game|Participants were asked to play the game for at least one hour per day for 16 days. The number of participants who reported playing the game everyday and the number of participants who reported playing the game for an hour or more each time are presented here.|Day 17 (post-intervention)|Only participants randomized to the intervention arm are included in this analysis.|||Participants|||Count of Participants
2540263|NCT03054051|Primary|Number of Participants Feeling Very Safe|Personal safety associated with being in possession of the phone was assessed by the post-intervention survey. Phones provided for the intervention were set up so that all other features were blocked and only function the phone could perform was playing the game.|Day 17 (post-intervention)||||Participants|||Count of Participants
2540264|NCT03054051|Primary|Number Reporting the Game is Valuable|The value of the game was assessed with several questions regarding how much the participants learned and how useful the information is. The number of participants reporting that they learned a lot, found the information very useful now, and found the information very useful for the future, are presented below.|Day 17 (post-intervention)|This analysis includes participants randomized to the intervention arm.|||Participants|||Count of Participants
2540265|NCT03054051|Primary|Number Reporting Game Was Very Fun|"Game acceptability was assessed by asking participants how fun playing the game was. The number of participants reporting that the game was very fun are presented here."|Day 17 (post-intervention)|This analysis includes participants in the intervention arm.|||Participants|||Count of Participants
2540266|NCT03054051|Primary|Number of Phones Returned|The phone retention rate (phones not lost during the intervention) was assessed by the number of phones returned at the end of the intervention.|Month 2||||phones|||Number
2540267|NCT03054051|Primary|Number of Participants Completing the Study|The number of participants who completed all study visits after providing consent are presented here.|Duration of Study (Up to 4 Months)||||Participants|||Count of Participants
2540268|NCT03054051|Primary|Number of Participants Lost to Follow Up|The number of participants who consented to participate but then later could not be reached prior to completing all study visits.|Duration of Study (Up to 4 Months)||||Participants|||Count of Participants
2540269|NCT03054051|Primary|Time to Recruitment of 60 Participants|The number of days needed to recruit 60 participants.|Month 1||||days|||Number
2540270|NCT03054051|Primary|Number Interested in Participating|To evaluate the feasibility of conducting a technology based intervention in a low resource area, the number of eligible individuals who were interested in participating after hearing about the study was examined. Letters were sent to 150 families inviting them to attend an informational meeting and 126 attended a meeting and were assess for eligibility.|Month 1|This analysis includes all of the individuals who expressed interest in the study by attending an informational meeting.|||Participants|||Count of Participants
2540271|NCT03053960|Secondary|Incidence of Sparing Resection||Up to 2 years|The study was terminated by the IRB. Sincere efforts were made to gather and report the data, however, no data is available for the study.||||||
2540272|NCT03053960|Primary|Accurate Predication of the Presence or Absence of Bone Invasion by Oral Squamous Cell Carcinoma by Helical CT, PET/CT, MRI and CBCT|Sensitivity and specificity of the clinical exam, CBCT, helical CT, PET/CT, MRI and any other imaging modality used in detection of bone invasion will be calculated, as compared to the histological examination of the specimens. The positive and negative predictive value will be calculated for each modality using the true positive and negatives as well as false positive and negative values|Up to 2 years|The study was terminated by the IRB. Sincere efforts were made to gather and report the data, however, no data is available for the study.||||||
2540273|NCT03053427|Secondary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) with onset after the start of the run-in period. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. Serious TEAE was an AE considered serious.|From first dose of study drug up to week 13|Safety Analysis Set (SAF) consisted of all participants given at least one dose of the study drug for the treatment period.|||Participants|||Count of Participants
2540274|NCT03053427|Secondary|Change From Baseline in Health Status Score of EuroQol-5 Dimension-5 Level (EQ-5D-5L)|Health status was assessed by general visual analog scale (VAS). The VAS ranges from 0 (worst health status) and 100 (best health status).|Baseline and EoT (week 12)|FAS.|||units on a scale||Standard Deviation|Mean
2540276|NCT03053427|Secondary|Change From Baseline in Athens Insomnia Scale|Athens Insomnia Scale consisted of 8-item scale (range of subscale scores, 0-3). The scale range of Athens Insomnia was 0-24. Higher scores represent poorer sleep quality. ANCOVA model with the baseline value as a covariate was used.|Baseline and EoT (week 12)|FAS.|||units on a scale||95% Confidence Interval|Least Squares Mean
2540277|NCT03053427|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index Total Score (PSQI)|The self-rated items of the PSQI generate seven component scores (range of subscale scores, 0-3). The sum of these seven component scores yielded one global score of subjective sleep quality (range, 0-21). Higher scores represent poorer subjective sleep. ANCOVA model with the baseline value as a covariate was used.|Baseline and EoT (week 12)|FAS|||units on a scale||95% Confidence Interval|Least Squares Mean
2540278|NCT03053427|Secondary|Percentage of Participants With a Patient-rated Clinical Global Impression (PCGI) Response|"PCGI was assessed by 7-point ordinate scale. Participants who were Very much improved or Much improved were defined as responders."|EoT (week 12)|FAS.|||percentage of participants||95% Confidence Interval|Number
2540279|NCT03053427|Secondary|Percentage of Participants With an Investigator-rated Clinical Global Impression (ICGI) Response|"ICGI was assessed by 7-point ordinate scale. Participants who were Very much improved or Much improved were defined as responders."|EoT (week 12)|FAS.|||percentage of participants||95% Confidence Interval|Number
2540280|NCT03053427|Secondary|Change From Baseline in IRLS Score at Each Time Point|ANCOVA model with the baseline value as a covariate was used.|Baseline and weeks 1, 2, 4, 6, 8, 10, 12 and EoT (week 12)|FAS.|||units on a scale||95% Confidence Interval|Least Squares Mean
2540281|NCT03053427|Primary|Change From Baseline in International Restless Legs Syndrome Rating Scale (IRLS) Score at Week 12|The IRLS consisted of 10-item scale for assessing severity of restless legs syndrome (RLS) with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 to 40. Higher IRLS score indicated greater disease activity. Mixed Model of Repeated Measurements (MMRM) model with compound symmetry as a covariance structure was used. The explanatory variables of the model included treatment group, IRLS score at baseline, age category, estimated creatinine clearance category, time point, and interaction of treatment group and time point.|Baseline and week 12|Full Analysis Set (FAS) consisted of all participants who received the study drug for the treatment period and were evaluated for at least one efficacy (either primary or secondary) endpoint during the treatment period.|||units on a scale||95% Confidence Interval|Least Squares Mean
2540282|NCT03053180|Secondary|Percentage of Participants With Missing SVR12 Data||12 weeks after the last dose of study drug (week 24)|Core population|||percentage of participants||95% Confidence Interval|Number
2540283|NCT03053180|Secondary|Percentage of Participants With Failure to Suppress|Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.|12 weeks|Core population|||percentage of participants||95% Confidence Interval|Number
2540284|NCT03053180|Secondary|Percentage of Participants With Breakthrough|Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.|12 weeks|Core population|||percentage of participants||95% Confidence Interval|Number
2540285|NCT03053180|Secondary|Percentage of Participants With Relapse|Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.|End of treatment (week 12) and up to 12 weeks after the end of treatment.|Core population|||percentage of participants||95% Confidence Interval|Number
2540286|NCT03053180|Secondary|Percentage of Participants Achieving Virological Response at End of Treatment (EoT)|Virological response is defined as HCV RNA less than 50 IU/mL.|End of treatment, maximum of 12 weeks|Core population|||percentage of participants||95% Confidence Interval|Number
2540287|NCT03053180|Primary|Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.|12 weeks after the last dose of study drug (week 24)|Core population|||percentage of participants||95% Confidence Interval|Number
2540288|NCT03052764|Secondary|Percentage of Participants Who Have a Positive Treatment Response on the Treatment Benefit Scale (TBS)|The participant rated their condition during treatment using the TBS 4-point scale where: 1=greatly improved, 2=improved, 3=not changed or 4=worsened. A positive treatment response is either as score of 1=greatly improved or 2=improved.|Week 12|mITT Population included all randomized participants who had at least one efficacy assessment at Baseline and a postbaseline visit. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||percentage of participants|||Number
2540289|NCT03052764|Secondary|Change From Baseline in Daily Average Number of Nocturia Episodes|The participants recorded the number of nocturia episodes in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An ANCOVA model with treatment as a factor at 2 levels, and the number of UUI episodes reported at Baseline (<= 9 versus > 9 daily episodes) and Baseline daily average number of nocturia episodes as covariates was used for analyses.|Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to, 3 consecutive days prior to Week 12|mITT Population included all randomized participants who had at least one efficacy assessment at Baseline and a postbaseline visit. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||nocturia episodes per day||Standard Error|Least Squares Mean
2540290|NCT03052764|Secondary|Change From Baseline in Daily Average Number of Urgency Episodes|The participant recorded the number of urgency episode in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An ANCOVA model with treatment as a factor at 2 levels, and the number of UUI episodes reported at Baseline (<= 9 versus > 9 daily episodes) and Baseline daily average number of urgency episodes as covariates was used for analyses.|Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12|mITT Population included all randomized participants who had at least one efficacy assessment at Baseline and a postbaseline visit. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||urgency episodes per day||Standard Error|Least Squares Mean
2541036|NCT03036163|Secondary|Total (Plasma) Clearance (Cl) of PBTZ169|The Cl parameter was calculated using the following formulas: for Day 1: Cl=D/AUCinf; for Days 7 and 14: Clss=D/AUCτ|Up to 72 hours after the last drug administration|PKA|||L/h||Standard Deviation|Mean
2540291|NCT03052764|Secondary|Change From Baseline in Daily Average Number of Micturition Episodes|The participant recorded the number of micturition episodes in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An ANCOVA model with treatment as a factor at 2 levels, and the number of UUI episodes reported at Baseline (<= 9 versus > 9 daily episodes) and Baseline daily average number of micturition as covariates was used for analyses.|Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12|mITT Population included all randomized participants who had at least one efficacy assessment at Baseline and a postbaseline visit. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||micturition episodes per day||Standard Error|Least Squares Mean
2540292|NCT03052764|Secondary|Percentage of Participants Who Achieved Complete Continence|Complete continence is defined as 100% reduction in urinary incontinence from Baseline.|Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12]|mITT Population included all randomized participants who had at least one efficacy assessment at Baseline and a postbaseline visit. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||percentage of participants|||Number
2540293|NCT03052764|Primary|Change From Baseline in Daily Average Number of Urinary Incontinence Episodes|The participant recorded urinary incontinence in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An analysis of covariance (ANCOVA) model with treatment as a factor at 2 levels, and the number of Urgency Urinary Incontinence (UUI) episodes reported at Baseline (<= 9 versus > 9 daily episodes) and Baseline daily average number of episodes of incontinence as covariates was used for analyses.|Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12|Modified Intent-to-treat (mITT) Population included all randomized participants who had at least one efficacy assessment at Baseline and a postbaseline visit.|||incontinence episodes per day||Standard Error|Least Squares Mean
2540294|NCT03052725|Secondary|Participants With Treatment-Emergent Anti-Drug Antibody (ADA) At the End-0f-Study Visit (Week 51)|The endpoint was defined to evaluate immunogenicity after study drug washout since the end of study visit on Week 51 was to be 19 weeks after the final dose of study drug. Due to the early termination of the study no participants had an end of study visit.|Week 51|Safety Analysis set||||||
2540295|NCT03052725|Secondary|Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Responses|"Treatment-emergent responses were defined as a positive sample post-baseline (negative baseline) OR a titer increase of >=4-fold relative to a positive baseline sample.~Two types of antibody assay were performed, an immunogenicity status assay (ADA) and neutralizing assay (NAb).~The ADA assay produces a positive or negative result. For samples with a positive result, a neutralizing assay was performed, which also produces a positive or negative result."|Baseline - date of randomization in the previous study (C38072-AS-30025 or C38072-AS-30027), Weeks 8, 24, 36 or early withdrawal|Safety Analysis set|||Participants|||Count of Participants
2540296|NCT03052725|Secondary|Asthma Quality of Life Questionnaire Administered to Participants Ages 12-70 Years (AQLQ +12) Overall Score: Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36|"The AQLQ +12 is a modified version of the standardized AQLQ, which was developed to measure functional impairments experienced by adults ≥17 years of age. The AQLQ +12 is valid for patients 12 to 70 years of age and includes 32 questions in 4 domains (symptoms, activity limitation, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and score each of the questions on a 7-point scale, where 7=not at all limited and 1=totally limited. The overall score of the AQLQ +12 was derived as the average of the 32 questions, thus, the total score ranges from 1 (indicates total impairment) to 7 (indicates no impairment).~Positive change from baseline values indicate improved quality of life."|Baseline (Week 0), Weeks 8, 24, 36|Safety Analysis set of participants age 12-70 years|||units on a scale||Standard Deviation|Mean
2540297|NCT03052725|Secondary|Asthma Control Questionnaire-6 (ACQ-6) Total Score: Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36|The ACQ-6 is a validated asthma assessment tool that has been widely used. There are 6 self-assessment questions. Each item on the ACQ-6 has a possible score ranging from 0 to 6 and the total score is the mean of all responses. The seven-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled.' Negative change from baseline values indicate improved asthma control.|Baseline (Week 0), Weeks 8, 24, 36|Safety analysis set|||units on a scale||Standard Deviation|Mean
2540298|NCT03052725|Secondary|Total Inhalations of Reliever Bronchodilator Medication: Baseline Values and Change From Baseline Values at Weeks 1, 4, 8, 24 and 36|"Total inhalations of reliever bronchodilator medication (eg, short-acting beta-agonist [SABA]) measured using weekly averages.~The average was calculated as the sum of all values divided by the number of non-missing assessments. There was no imputation of missing data. At least 4 of the 7 measurements need to be recorded for a week to be included in the analysis; otherwise the week was treated as missing."|Baseline (Week 0), Weeks 1, 4, 8, 24, 36|Safety Analysis set|||inhalations||Standard Deviation|Mean
2540299|NCT03052725|Secondary|Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 16-20 and Weeks 32-36|"Daily OCS dose is defined as total OCS dose in a day (accounting for reported dose and dose frequency) and converting the total daily dose to a prednisone-equivalent dose.~Baseline dose is the prescribed OCS dose on the day of first dose of study drug in this study. Dose at Weeks 16-20 and 32-36 is the mean of all daily OCS doses during the week range.~Percent change = 100 * (absolute change / baseline dose)"|Week 0 (baseline), Weeks 16-20, Weeks 32-36|Safety Analysis set of participants on daily OCS at baseline|||percent change||Standard Deviation|Mean
2540300|NCT03052725|Secondary|Morning Ambulatory Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 1, 4, 8, 24 and 36|A weekly average of daily morning ambulatory FEV1 (measured by the handheld spirometry device) was derived using 7-day window intervals. The average was calculated as the sum of all values divided by the number of non-missing assessments. There will be no imputation of missing data. At least 4 of the 7 measurements need to be recorded for a week to be included in the analysis; otherwise the week was treated as missing.|Week 0 (baseline), Weeks 1, 4, 8, 24, 36|Safety analysis set|||liters||Standard Deviation|Mean
2541037|NCT03036163|Secondary|Mean Plasma Retention Time (MRT) of PBTZ169||Up to 72 hours after the last drug administration|PKA|||h||Standard Deviation|Mean
2540301|NCT03052725|Secondary|Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1): Baseline Values and Change From Baseline Values at Weeks 8, 24 and 36|"The FEV1 is the volume of air that can be forcibly exhaled from the lungs in the first second, measured in liters.~Pre-bronchodilator spirometry assessments at designated clinic visits (weeks 0, 8, and 24, and 36) should only be performed after withholding short-acting bronchodilators (ie, inhaled short-acting beta-adrenergic agonists and/or short-acting anticholinergics) for at least 6 hours and long-acting bronchodilators ie, inhaled long-acting beta-adrenergic agonists and long acting anticholinergic agents) for at least 12 or 24 hours, according to their labeled dose schedule."|Week 0 (baseline), Weeks 8, 24, 36|Safety Analysis set|||liters||Standard Deviation|Mean
2540302|NCT03052725|Secondary|Mean Number of School/Work Days Missed Due to Asthma During the Treatment Period|Participants with no school or work days missed due to asthma are included in the counts.|Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug|Safety Analysis set|||days||Standard Deviation|Mean
2540303|NCT03052725|Secondary|Mean Number of Days of Hospital Stay During the Treatment Period|Participants with no hospitalizations are included.|Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug|Safety Analysis set|||days||Standard Deviation|Mean
2540304|NCT03052725|Secondary|Annualized Rate of Clinical Asthma Exacerbations (CAEs) Requiring Asthma-Specific Hospital Admissions or Emergency Room Visits|"Data is included between the first dose of study drug to the end of treatment visit for completed participants, and the first dose of study drug to 4 weeks after the last dose of study drug for patients who discontinued treatment early.~Annual rate is defined as the number of events/(duration of treatment [days]/365.25).~Participants with zero events are included."|Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.|Safety Analysis set|||CAEs / year||Standard Deviation|Mean
2540305|NCT03052725|Secondary|Annualized Rate of Clinical Asthma Exacerbations (CAEs)|"Data is included between the first dose of study drug to the end of treatment visit for completed participants, and the first dose of study drug to 4 weeks after the last dose of study drug for patients who discontinued treatment early.~Annual rate is defined as the number of events/(duration of treatment [days]/365.25).~Participants with zero events are included."|Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.|Safety Analysis set|||CAEs / year||Standard Deviation|Mean
2540306|NCT03052725|Secondary|Participants With Potentially Clinically Significant Abnormal Vital Sign Values|"Participants are included in the counts if the worst study value reaches the following clinically significant levels:~Diastolic blood pressure (high): >100 mmHg and increase >=12 for participants >=18 years; >85 mmHg and increase >=12 for participants 12 - < 18 years Pulse rate (high): >100 beats/minute and increase >=12 Respiratory rate (high): >24 breaths/minute and increase >=10 for participants >=18 years >20 breaths/minute and increase >=10 for participants 12 - < 18 years Systolic blood pressure (high): >160 mmHg and increase >=30 for participants >=18 years; >130 mmHg and increase >=30 for participants 12 - < 18 years Temperature (high): >38.1 celsius and increase >=1.1 Temperature (low): <35.8 celsius"|Week 0 (baseline), Weeks 4, 8, 12, 16,20, 24, 28, 32, 36 plus any unscheduled visits|Safety analysis set of participants with a baseline and post-baseline result for each variable|||Participants|||Count of Participants
2540307|NCT03052725|Secondary|Participants' Tolerability and Injection Site Reactions by Domain and Worst Overall Severity|"The worst finding for participants in each tolerability and injection site domain from all treatment weeks is summarized. Local tolerability at the injection site was assessed approximately 1 hour after study drug administration.~Severity was rated on a 4-level scale of none, mild, moderate and severe."|Weeks 4, 8, 12, 16, 20, 24, 28, and 36|Safety analysis set|||Participants|||Count of Participants
2540308|NCT03052725|Secondary|Participants With Potentially Clinically Significant Abnormal Serum Chemistry Values|"Participants are included in the counts if the worst study value reaches the following clinically significant levels:~Alanine Aminotransferase (high): >=3* upper limit of normal (ULN) and increase >0 Aspartate Aminotransferase (high): >=3* upper limit of normal (ULN) and increase >0 Bilirubin (high): >=34.2 micromol/L and increase >0 Blood Urea Nitrogen (high): >=10.71 mmol/L and increase >0 Creatine Phosphokinase (high): >10* ULN and increase >0 Creatine Phosphokinase (medium high): >=3.1*ULN and <=10*ULN and increase >0 Creatinine (high): >=177 micromol/L and increase >0"|Week 0 (baseline), Weeks 4, 8, 24, 36 plus any unscheduled visits|Safety analysis set of participants with a baseline and post-baseline result for each variable|||Participants|||Count of Participants
2540309|NCT03052725|Secondary|Participants With Potentially Clinically Significant Abnormal Hematology Values|"Participants are included in the counts if the worst study value reaches the following clinically significant levels:~Eosinophils (high): >=1.5*10^9/L and increase >0 Hematocrit (low): >=18 years old: <0.32 L/L for females; <0.37 L/L for males plus a decrease >0 for both or 12 to <18 years old: <0.30 L/L and a decrease >0 for both females and males Hemoglobin (low): >=18 years old: <=95 g/L and decrease >0; 12 to <18 years old: <=100 g/L and decrease >0 Leukocytes (high): >=20*10^9/L and increase >0 Leukocytes (low): <=3*10^9/L and decrease >0 Neutrophils (low): <=1*10^9/L and decrease >0 Platelets (low): <=75*10^9/L and decrease >0"|Week 0 (baseline), Weeks 8, 24, 36 plus any unscheduled visits|Safety analysis set of participants with a baseline and post-baseline result for each variable|||Participants|||Count of Participants
2540326|NCT03052322|Secondary|Percentage of Participants With Clinically Meaningful Differences in Vital Signs|Vital signs including body temperature, respiratory rate, and heart rate (after 5-minute rest) were measured. Percentage of participants with clinically meaningful abnormalities in vital signs were reported. Clinical meaningful was determined by the investigator.|Up to Week 52|The Safety Analysis Set included all randomized participants who received at least one dose of study treatment.|||Percentage of Participants|||Number
2540356|NCT03051165|Secondary|Change in Heat Shock Protein 70 (HSP70)|To assess changes in the serum biomarker profile, blood will be collected from participants to be stored for future analyses of a variety of biochemical factors related to cardiovascular function. Heat shock protein 70 (HSP70) is a stress protein. Heat shock proteins increase in response to stress conditions such as inflammation and infection.|Baseline, Day 105, Day 137|Blood for serum biomarker assessments was not collected for any participants at any study visit.||||||
2540310|NCT03052725|Primary|Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event is any untoward medical occurrence, regardless of whether it has a causal relationship with study treatment. In this study, asthma exacerbations should not be recorded as adverse events unless assessed by the investigator as more severe than the patient's usual disease course. The period for reporting treatment-emergent adverse events was defined as the period after the first dose of study drug was administered until the end of treatment visit. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to up to Day 269; for participants who discontinued early for reasons other than study termination, the timeframe was first dose of study drug to 4 weeks after the last dose of study drug.|Safety analysis set|||Participants|||Count of Participants
2540311|NCT03052530|Secondary|Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention)|Clinically Significant Arrhythmias (requiring intervention)|Endpoint will be measured through hospital discharge (expected to be within 24 hours)|Analysis population consists of intent-to-treat subject population.|||Participants|||Count of Participants
2540312|NCT03052530|Secondary|Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel|In-hospital stent thrombosis (ST) within the target vessel|Endpoint will be measured through hospital discharge (expected to be within 24 hours)|Analysis population consists of intent-to-treat subject population.|||Participants|||Count of Participants
2540313|NCT03052530|Secondary|Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)|"In-hospital Major Adverse Cardiac Events (MACE)~All death (cardiac and non-cardiac)~Myocardial infarction (MI)~Target Lesion Revascularization (TLR)"|Endpoints will be measured through hospital discharge (expected to be within 24 hours)|Analysis population consists of intent-to-treat subject population.|||Participants|||Count of Participants
2540314|NCT03052530|Primary|Number of Participants With Device Procedural Success|"Device procedural success consisting of the following:~Successful delivery, inflation, deflation and withdrawal of the study balloon~No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon~Final TIMI flow grade of 3 at the conclusion of the PCI procedure"|Peri-procedural (at Day 0)|Analysis population consists of intent-to-treat subject population.|||Participants|||Count of Participants
2540315|NCT03052426|Secondary|Reported Musculoskeletal Discomfort at Work at 3 Months and 6 Months All Groups Combined|The Cornell Musculoskeletal Discomfort Questionnaire consists of three scales that were compiled 1) aches and pains, 2) discomfort and 3) interference due to aches and pains. All three scales included 9 questions centered on the occurrence in body regions, including the neck, shoulder, upper and lower back, upper arms, forearm/wrist, hip, thigh, and knee/lower leg. Aches and Pains was on a 5 point scale, from 1) Never to 5) Several Times a Day. Uncomfortable was on a 4 point scale, ranging from 0) No Discomfort to 3) Very Uncomfortable. Interference was on a 4 point scale from 0) Not a problem to 3) Substantially interfered. Higher scores indicated more problems in each of these areas.|Beginning of study, 3 months, and 6 months (end of study)|Secondary to the individual group sizes being small, we decided to do an analysis of all of the groups combined to determine if the intervention made any impact on musculoskeletal discomfort with use over time.|||units on a scale||Standard Deviation|Mean
2540316|NCT03052426|Primary|Reported Musculoskeletal Discomfort Per Group at 6 Months|Three scales were compiled 1) aches and pains, 2) discomfort and 3) interference due to aches and pains. All three scales included 9 questions centered on the occurrence in body regions, including the neck, shoulder, upper and lower back, upper arms, forearm/wrist, hip, thigh, and knee/lower leg. Aches and Pains was on a 5 point scale, from 1) Never to 5) Several Times a Day. Uncomfortable was on a 4 point scale, ranging from 0) No Discomfort to 3) Very Uncomfortable. Interference was on a 4 point scale from 0) Not a problem to 3) Substantially interfered. Higher scores indicated more problems in each of these areas.|6 months||||units on a scale||Standard Deviation|Mean
2540317|NCT03052426|Primary|Reported Musculoskeletal Discomfort Per Group at 3 Months|Three scales were compiled 1) aches and pains, 2) discomfort and 3) interference due to aches and pains. All three scales included 9 questions centered on the occurrence in body regions, including the neck, shoulder, upper and lower back, upper arms, forearm/wrist, hip, thigh, and knee/lower leg. Aches and Pains was on a 5 point scale, from 1) Never to 5) Several Times a Day. Uncomfortable was on a 4 point scale, ranging from 0) No Discomfort to 3) Very Uncomfortable. Interference was on a 4 point scale from 0) Not a problem to 3) Substantially interfered. Higher scores indicated more problems in each of these areas.|3 months|At this point in the study there were still 16 individuals enrolled.|||units on a scale||Standard Deviation|Mean
2540318|NCT03052322|Secondary|Mean Change From Baseline (Week 4) in Injection Site Pain as Assessed by Visual Analogue Scale (VAS) at Week 6 and 8|The participant's reported perception of pain was measured on a VAS where the slash drawn by the participant represents pain of increasing intensity. VAS score ranges from 0-10 millimeter [mm], where; 0 mm=no pain and 10 mm=worst possible pain. The first 2 injections was administered by qualified personnel. The next three doses of IMP (3-5) will be self-administered by the participant and injection site pain was assessed. Pain was recorded immediately after, 15 minutes after, and 1 hour after the injections received by the participants.|Immediately, 15 minutes and 1 hour post-injection on Baseline (Week 4), Week 6 and 8|"The Safety Analysis Set included all randomized participants who received at least one dose of study treatment. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified time points."|||Millimeter (mm)||Standard Deviation|Mean
2540327|NCT03052322|Secondary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death|Adverse event(AE) was defined as any untoward medical occurrence in participants which does not necessarily have causal relationship with treatment. A serious adverse event(SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Term TEAE is defined as AEs starting/worsening after first intake of the study drug. All abnormal physical examinations occurring during the study have been reported as Adverse events. TEAEs included both Serious TEAEs and non-serious TEAEs.|Baseline up to Week 69|The Safety Analysis Set included all randomized participants who received at least one dose of study treatment.|||Percentage of Participants|||Number
2540319|NCT03052322|Secondary|Euro-Quality of Life - 5 Dimension-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Score at Baseline, Week 12, 24 and 52|"EQ-5D-5L: Standardized, participant-rated questionnaire to assess health-related quality of life. EQ-5D-5L includes 2 components: EQ-5D-5L health state profile (descriptive system) and EQ-5D-5L Visual Analog Scale. EQ-5D-5L descriptive system provides a profile of participant's health state 5 dimensions:~mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. Responses to 5 dimension scores were combined and converted into single preference-weighted health utility index score 0 (worst health state) to 1 (better health state). EQ-VAS: Self-rated health status using a vertical VAS. EQ-VAS records participant's perceptions of their own current overall health in range from 0 (worst imaginable health) to 100 (best imaginable health)."|Baseline, Week 12, 24 and 52|"ITT Analysis Set included all participants randomly allocated to a treatment, based on intent to treat “as randomized” principle (planned treatment regimen rather than actual treatment given in case of any difference). Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified time points."|||Units on a scale||Standard Deviation|Mean
2540320|NCT03052322|Secondary|Euro-Quality of Life - 5 Dimension-5 Levels (EQ-5D-5L) Utility Index Score at Baseline, Week 12, 24 and 52|EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The EQ-5D-5L descriptive system provides a profile of the participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of the individual based on the UK scoring algorithm.|Baseline, Week 12, 24 and 52|"ITT Analysis Set included all participants randomly allocated to a treatment, based on intent to treat “as randomized” principle (planned treatment regimen rather than actual treatment given in case of any difference). Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified time points."|||Units on a scale||Standard Deviation|Mean
2540321|NCT03052322|Secondary|Short-Form Health Survey- 36 Items (SF-36) at Baseline, Week 12, 24 and 52|The Short Form Health Survey (SF-36) is a validated 36-item, patient-reported indication of overall health status not specific to any age, disease or Treatment group. The SF-36 questionnaire contains 36 questions pertaining to eight subscales of health status. These eight subscales were summarized as relating to either physical health or mental health. Physical component summary (PCS) is based primarily on physical functioning, role-physical, bodily pain, and general health scales and mental component summary (MCS) encompasses vitality, social functioning, role-emotional, and mental health scales. Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).|Baseline, Week 12, 24 and 52|"ITT Analysis Set included all participants randomly allocated to a treatment, based on intent to treat “as randomized” principle (planned treatment regimen rather than actual treatment given in case of any difference). Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified time points."|||Units on a scale||Standard Deviation|Mean
2540322|NCT03052322|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) Total Score at Baseline, Weeks 12, 24 and 52|The HAQ-DI is a participant-reported questionnaire that is commonly used in RA to measure disease associated disability (assessment of physical function). It consists of several questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. HAQ-DI scores range from 0 to 3. The disability section of the questionnaire scores the participant's self-perception on the degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do).|Baseline, Weeks 12, 24 and 52|"ITT Analysis Set included all participants randomly allocated to a treatment, based on intent to treat “as randomized” principle (planned treatment regimen rather than actual treatment given in case of any difference). Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified time points."|||Units on a scale||Standard Deviation|Mean
2540323|NCT03052322|Secondary|Percentage of Participants With Anti-Nuclear Antibody (ANA) and Anti Double-stranded Deoxyribonucleic Acid (Anti-dsDNA) at Baseline, Week 24 and 52|For ANA, positivity is defined as any participant with ANA titer greater than (>) 1:160 and negativity is defined as ANA titer less than (<) 1:160. For anti-ds DNA, positivity is defined as any participant with adsDNA > 15 units per milliliter (U/mL), intermediate category is defined as value between 10 U/mL to 15 U/mL and negativity is defined as adsDNA < 10 U/mL. Percentage of participants with anti-nuclear antibody (ANA) and anti double-stranded deoxyribonucleic acid (Anti-dsDNA) at baseline, week 24 and 52 were reported.|Baseline, Week 24 and 52|The Safety Analysis Set included all randomized participants who received at least one dose of study treatment.|||Percentage of Participants|||Number
2540324|NCT03052322|Secondary|Percentage of Participants With Clinically Significant Abnormal Values for 12-lead Electrocardiogram (ECG) at Week 12, 24, and 52|Percentage of participants with clinically significant abnormal values for 12-lead electrocardiogram (ECG) at week 12, 24, and 52 were reported.|Week 12, 24, and 52|"The Safety Analysis Set included all randomized participants who received at least one dose of study treatment. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified time points."|||Percentage of Participants|||Number
2540325|NCT03052322|Secondary|Percentage of Participants With Clinically Meaningful Differences in Laboratory Values|Laboratory parameters including hematology, urinalysis, and biochemistry analysis were analyzed.|Up to Week 52|The Safety Analysis Set included all randomized participants who received at least one dose of study treatment.|||Percentage of Participants|||Number
2541088|NCT03035708|Secondary|The Percentage of Subjects Abstinent During the Last Month of Treatment (Weeks 3-6).|The percentage of subjects abstinent from alcohol during the last month of treatment (weeks 3-6).|Weeks 3-6|mITT|||Participants|||Count of Participants
2540328|NCT03052322|Secondary|Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean Remission at Week 2, 4, 8, 12, 24 and 52|According to Boolean-based definition of remission of ACR/EULAR, a participant must satisfy all of the following: tender joint count <= 1, swollen joint count <= 1, CRP <= 1 mg/dL, and Patient's Global Assessment of Disease Activity <= 1 (0 to 10 VAS). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition.|Week 2, 4, 8, 12, 24 and 52|"ITT Analysis Set included all participants randomly allocated to a treatment, based on intent to treat “as randomized” principle (planned treatment regimen rather than actual treatment given in case of any difference). Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified time points."|||Percentage of Participants||95% Confidence Interval|Number
2540329|NCT03052322|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Total Score at Week 2, 4, 8, 12, 24 and 52|Clinical Disease Activity Index (CDAI) is a composite index (without acute-phase reactant) for assessing disease activity. The CDAI was calculated based on following formula: CDAI = 28 joint count for swelling (SJC28) + 28 joint count for tenderness (TJC28) + GH + PGA. Where, -GH = general health component of the DAS (i.e., Patient's Global Assessment of Disease Activity, assessed using a scale of 1 to 100 where 100 is maximal activity; for analyses, GH was divided by 10 and converted to a 0.5 scale, i.e., 0, 0.5, 1, 1.5 etc. where [0-0.25] = 0, [0.25-0.75] = 0.5, [0.76-1.25] = 1, etc.). -PGA = Physician's Global Assessment of Disease Activity assessed using a scale of 1 to 100 where 100 is maximal activity. For analyses, PGA was divided by 10 and converted to a 0.5 scale, ie, 0, 0.5, 1, 1.5 etc. where [0-0.25] = 0, [0.25-0.75] = 0.5, [0.76-1.25] = 1, etc. The CDAI ranges from 0 to 76. Lower score indicates less disease activity.|Baseline, Week 2, 4, 8, 12, 24 and 52|"ITT Analysis Set included all participants randomly allocated to a treatment, based on intent to treat “as randomized” principle (planned treatment regimen rather than actual treatment given in case of any difference). Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified time points."|||Units on a scale||Standard Deviation|Mean
2540330|NCT03052322|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Total Score at Week 2, 4, 8, 12, 24, and 52|SDAI is numerical sum of 5 outcome parameters: tender & swollen joint count (based on 28-joint assessment), Patient's & Physician's Global Assessment of Disease Activity (VAS) & level of C-reactive protein (CRP)(milligram per deciliter (mg/dL), normal<1 mg/dL). SDAI was calculated based on following formula: SDAI = 28 joint count for swelling (SJC28) + 28 joint count for tenderness (TJC28)+GH+PGA+CRP Where: -GH =general health component of DAS (i.e. Patient's Global Assessment of Disease Activity, assessed using scale of 1 to 100 where 100 is maximal activity; For analyses, GH was divided by 10 & converted to 0.5 scale (0, 0.5, 1, 1.5).-PGA = Physician's Global Assessment of Disease Activity assessed using scale of 1 to 100 where 100 is maximal activity. For analyses, PGA will be divided by 10 & converted to 0.5 scale (0, 0.5, 1, 1.5). where [0-0.25] = 0, [0.25-0.75] = 0.5, [0.76-1.25] = 1, etc. The total score range is 0-86 & lower score indicates less disease activity.|Baseline, Week 2, 4, 8, 12, 24, and 52|"ITT Analysis Set included all participants randomly allocated to a treatment, based on intent to treat “as randomized” principle (planned treatment regimen rather than actual treatment given in case of any difference). Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified time points."|||Units on a scale||Standard Deviation|Mean
2540331|NCT03052322|Secondary|Percentage of Participants With Disease Activity Score Based on 28-joints Count- Erythrocyte Sedimentation Rate (DAS28-ESR) Low Disease Activity and Remission at Week 2, 4, 8, 12, 24, and 52|Disease Activity Score calculated on 28 joints is composite score derived from 4 measures: number of swollen joints (out of 28), -number of tender joints (out of 28), -Erythrocyte sedimentation rate (ESR), -Patient's Global Assessment of Disease Activity on visual analog scale (VAS). Overall disease activity score DAS28 was derived using following formulas from DAS28: DAS28=0.56*√(TJC28)+0.28*√(SJC28) + 0.014*GH+0.70*ln(ESR). Where: -TJC28 = 28 joint count for tenderness, -SJC28 = 28 joint count for swelling, -ln(ESR) = natural logarithm of ESR, -GH = general health component of DAS (ie, Patient's Global Assessment of Disease Activity, assessed using scale of 1 to 100 where 100 is maximal activity); For analyses, GH was divided by 10 and converted to a 0.5 scale, i.e., 0, 0.5, 1, 1.5. DAS28-ESR of >5.1 implies active disease, <3.2 low disease activity, and <2.6 remission.|Week 2, 4, 8, 12, 24, and 52|"ITT Analysis Set included all participants randomly allocated to a treatment, based on intent to treat “as randomized” principle (planned treatment regimen rather than actual treatment given in case of any difference). Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified time points."|||Percentage of Participants||95% Confidence Interval|Number
2540332|NCT03052322|Secondary|Change From Baseline in Disease Activity Score Based on a 28 Joint Count- Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Week 2, 4, 8, 12, 24 and 52|DAS calculated on 28 joints is composite score derived from 4 measures: number of swollen joints (out of 28), number of tender joints (out of 28), Erythrocyte sedimentation rate (ESR), Patient's Global Assessment of Disease Activity on visual analog scale (VAS). Overall disease activity score DAS28 was derived using following formulas from DAS28:DAS28=0.56*√(TJC28)+0.28*√(SJC28) + 0.014*GH+0.70*ln(ESR). Where: TJC28 = 28 joint count for tenderness, SJC28 = 28 joint count for swelling, ln(ESR) = natural log of ESR, GH = general health component of DAS (ie, Patient's Global Assessment of Disease Activity, assessed using scale of 1-100 where 100 is maximal activity); For analyses, GH divided by 10 & converted to 0.5 scale, i.e, 0, 0.5, 1, 1.5. DAS28-ESR of >5.1 implies active disease, <3.2 low disease activity, & <2.6 remission. Change of 1.2(twice measurement error)=significant change of disease activity state. Overall score ranges from 0-10 where higher score means more severe disease.|Baseline, Week 2, 4, 8, 12, 24 and 52|"ITT Analysis Set included all participants randomly allocated to a treatment, based on intent to treat “as randomized” principle (planned treatment regimen rather than actual treatment given in case of any difference). Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified time points."|||Units on a scale||Standard Deviation|Mean
2540355|NCT03051165|Secondary|Change in High Sensitivity Cardiac Troponin (HS-troponin)|To assess changes in the serum biomarker profile, blood will be collected from participants to be stored for future analyses of a variety of biochemical factors related to cardiovascular function. Elevated high sensitivity cardiac troponin (HS-troponin) indicates injury to the heart.|Baseline, Day 105, Day 137|Blood for serum biomarker assessments was not collected for any participants at any study visit.||||||
2540333|NCT03052322|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Response at Week 2, 4, 8, 12, 24 and 52|The ACR 70 Response is defined as greater than or equal to (>=) 70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS ; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas). The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and acute-phase marker (CRP).|Week 2, 4, 8, 12, 24 and 52|"ITT Analysis Set included all participants randomly allocated to a treatment, based on intent to treat “as randomized” principle (planned treatment regimen rather than actual treatment given in case of any difference). Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified time points."|||Percentage of Participants||95% Confidence Interval|Number
2540334|NCT03052322|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Response at Week 2, 4, 8, 12, 24 and 52|The ACR 50 Response is defined as greater than or equal to (>=) 50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS ; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas). The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and acute-phase marker (CRP).|Week 2, 4, 8, 12, 24 and 52|"ITT Analysis Set included all participants randomly allocated to a treatment, based on intent to treat “as randomized” principle (planned treatment regimen rather than actual treatment given in case of any difference). Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified time points."|||Percentage of Participants||95% Confidence Interval|Number
2540335|NCT03052322|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 2, 4, 8, 24 and 52|The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS ; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas). The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and acute-phase marker (CRP).|Week 2, 4, 8, 24 and 52|"ITT Analysis Set included all participants randomly allocated to a treatment, based on intent to treat “as randomized” principle (planned treatment regimen rather than actual treatment given in case of any difference). Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified time points."|||Percentage of Participants||95% Confidence Interval|Number
2540336|NCT03052322|Secondary|Percentage of Participants With Confirmed Neutralizing Antibodies (NAb) Status to Adalimumab|Percentage of participants with confirmed neutralizing antibodies status to Adalimumab were reported.|Baseline, Week 2, 4, 12, 24, 36 and 52|"The Safety Analysis Set included all randomized participants who received at least one dose of study treatment. Here Number of participants analyzed signifies those who were evaluable for this outcome measure and Number analyzed signifies those participants who were evaluable at specified time points."|||Percentage of Participants|||Number
2540337|NCT03052322|Secondary|Anti-Drug Antibodies (ADAs) Titer Levels for Adalimumab|Titer was defined as the degree to which the antibody-serum sample could be diluted and still contained detectable amounts of antibody. Anti-Drug Antibodies (ADAs) titers for adalimumab was reported. Data was collected using validated bioanalytical method.|Baseline, Week 2, 4, 12, 24, 36 and 52|"The Safety Analysis Set included all randomized participants who received at least one dose of study treatment. Here Number of participants analyzed signifies those who were evaluable for this outcome measure and Number analyzed signifies those participants who were evaluable at specified time points."|||Titer||Full Range|Median
2540338|NCT03052322|Secondary|Percentage of Participants With Positive Anti-Drug Antibodies (ADAs) Status to Adalimumab|Percentage of participants with positive anti-Drug antibodies (ADAs) status to Adalimumab were reported.|Baseline, Week 2, 4, 12, 24, 36 and 52|"The Safety Analysis Set included all randomized participants who received at least one dose of study treatment. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified time points."|||Percentage of Participants|||Number
2540339|NCT03052322|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 12|The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS ; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), participant's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas). The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and acute-phase marker (CRP).|Week 12|"Intent-To-Treat (ITT) Analysis Set included all participants randomly allocated to a treatment, based on intent to treat “as randomized” principle (planned treatment regimen rather than actual treatment given in case of any difference). Here Number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of Participants||95% Confidence Interval|Number
2540340|NCT03052322|Primary|Percentage of Participants With Treatment-emergent Adverse Events of Special Interest (AESI)|Adverse event (AE) was defined as any untoward medical occurrence in participants, which does not necessarily have causal relationship with treatment. Term Treatment-emergent Adverse Events (TEAE) is defined as AEs starting/worsening after first intake of the study drug. Hypersensitivity was the pre-defined TEAE of special Interest for this study. The percentage of participants with treatment emergent AESIs (hypersensitivity) were reported.|Up to Week 52|The Safety Analysis Set included all randomized participants who received at least one dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2540341|NCT03051646|Secondary|Exercise-induced Body Temperature Increase|Measure of interest is increase in body temperature from pre- to post-exercise test in each treatment condition (ASA vs. placebo)|Effect of treatment on body temperature in a single session (i.e., pre- to post- exercise test) to be completed within a 14-day period|subsample of people who self- identified as heat-sensitive during exercise (n=8)|||degrees Fahrenheit||Standard Deviation|Mean
2540342|NCT03051646|Primary|Change in Time to Exhaustion|The measure of interest is the length of time (in seconds) spent exercising at each session. This time has no pre-set upper limit, i.e. patients are free to exercise as long as they wish. This means that the time will not be censored. However, please note that healthy adults' time to exhaustion is approximately 12 minutes.|ASA's effect will be assessed from date of randomization until cessation of exercise test at each of two study visits to be completed within a 14-day period.|All participants were recruited from the Columbia MS Center for Research and Treatment in New York, New York.|||seconds||Standard Deviation|Mean
2540343|NCT03051607|Secondary|To Evaluate the Effects of Tozadenant on the Number of Participants With Occurrence of Impulsive Behavior - Modified Minnesota Impulse Disorder Interview (mMIDI)|"The Minnesota Impulsive Disorders Interview (MIDI) 8 is a global instrument that includes questions for compulsive gambling, buying, and sexual behavior (as well as other disorders not reported to occur in PD).~The mMIDI consists of 5 modules: compulsive buying, compulsive gambling, compulsive eating, hypersexuality and punding.~Positive Answer: Any answer other than no on any question is considered a yes/positive answer.~Negative Module: A module is considered negative if the patient's answer to a gateway (initial) question is no or if a patient answers yes to a gateway question and no to all of the remaining answers after the gateway question in that module.~Positive Module: A module is considered positive if a patient gives a positive answer (No = 0, rarely = 1, occasionally = 2, frequently = 3) to any question after the gateway (initial) question in one or more of the 5 modules."|Up to 28 Weeks including safety follow-up visit.|Planned patient enrollment numbers were not achieved as this study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. No patient completed the 52 Week study treatment period prior to Sponsor termination of the study. .|||Participants|||Count of Participants
2540344|NCT03051607|Secondary|To Evaluate the Effects of Tozadenant on the Number of Participants With Suicidal Ideation or Behavior Using the Columbia-Suicide Severity Scale (C-SSRS) Summarized by Visit.|"The Columbia Suicide Severity Rating Scale (C-SSRS) is a standardized suicidality rating system. The interview measures presence of suicidality and consists of 4 categories: suicidal ideation, intensity of ideation, suicidal behavior, and actual/potential lethality.~Suicidal Ideation - A series of 1 -5 questions with 5 types of ideation of increasing severity. Score of Yes = 1, No= 0. A positive answer to question 4 (active suicidal ideation with some intent to act) or 5 (active suicidal ideation with specific plan and intent) indicates that the individual has some intent to act on suicidal thoughts and will need further evaluation.~Suicidal Behavior - Different types of suicidal behavior are scored (Yes=1, No=0) and identify the occurrence of actual, interrupted, or aborted attempts; preparatory behaviors; and suicide. The total number of each type of suicidal behavior show the density of suicide, (more behaviors represent a higher degree of risk)."|Up to 28 Weeks including safety follow-up visit.|Planned patient enrollment numbers were not achieved as this study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. No patient completed the 52 Week study treatment period prior to Sponsor termination of the study.|||Participants|||Count of Participants
2540345|NCT03051607|Secondary|To Evaluate the Effects of Tozadenant on the Occurrences of Daytime Drowsiness by Using the Epworth Sleepiness Scale.|The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a short questionnaire. Minimum range is 0 - Maximum range is 24. A score within the range 0−9 is considered to be normal while a score within the range of 10−24 would indicate that medical help should be solicited.|Up to 28 Weeks including safety follow-up visit.|Planned patient enrollment numbers were not achieved as this study and the tozadenant development program were terminated early, based on an unexpected emerging safety signal. No patient completed the 52 Week study treatment period prior to Sponsor termination of the study.|||score on a scale||Standard Deviation|Mean
2540346|NCT03051607|Primary|To Evaluate the Safety and Tolerability of Tozadenant in Levodopa-treated PD Patients Experiencing Motor Fluctuations.|The primary objective of this study was to evaluate the safety and tolerability of tozadenant in levodopa-treated Parkinson's Disease (PD) patients experiencing motor fluctuations, based on assessment of treatment-emergent adverse events (TEAEs), vital signs, electrocardiograms (ECGs), and clinical laboratory tests. A total of 66 patients were enrolled in 27 study centers across 6 countries: USA, United Kingdom, Italy, Canada, Spain and Hungary, and were included in the Safety Set (SS).|Up to 28 Weeks including safety follow-up visit.|Safety evaluation was based on Safety Set which included all 66 patients enrolled in the study.|||Participants|||Count of Participants
2540347|NCT03051217|Secondary|Percentage of Participants With Positive Anti-Certolizumab Pegol-antibody Levels in Plasma|"A pre-anti-drug (CZP) antibody (ADA) positive subject was defined as having a confirmed positive sample at Baseline. A pre-ADA negative subject was defined as having a Screening below the cut point (BCP) sample, or a screening above the cut point (ACP) sample, but not confirmed positive at Baseline.~A treatment-emergent ADA positive subject was defined as either 1) pre-ADA negative subjects having at least 1 ADA confirmed positive sample or 2) pre-ADA positive subjects with at least 1 sample with greater then or equal to (>=) 1.67-fold increase from Baseline on CZP treatment."|Blood samples will be collected at Baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60|The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all participants in the RS who took at least 1 dose of the study medication and provided at least 1 quantifiable CZP plasma concentration.|||percentage of participants|||Number
2540348|NCT03051217|Secondary|Plasma Concentration of Certolizumab Pegol (CZP)|"Plasma concentration was expressed in micrograms per milliliter (μg/mL).~Values below Lower Limit of Quantification (LLOQ) were set to half the LLOQ to present summaries.~The geometric mean and geometric coefficient of variation were only displayed if at least 2/3 of the data were above the LLOQ."|Blood samples were collected at Baseline (Week 0) and at Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, 52, 60|The Pharmacokinetics Per-Protocol Set (PK-PPS) consisted of all participants in the RS who took at least 1 dose of the study medication and provided at least 1 quantifiable CZP plasma concentration.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2540349|NCT03051217|Secondary|Change From Baseline in Itch Numeric Rating Scale at Week 16|"This Outcome Measure applied to participants with moderate to severe chronic plaque Psoriasis (PSO).~The Itch Numeric Rating Scale (NRS) has been developed as a simple, single item instrument to assess the patient-reported severity of itch at its most intense during the past 24h period. Participants indicate itch severity by circling the integer that best describes the worst level of itching due to PSO in the past 24h period on an 11-point scale anchored at 0, representing no itching and 10, representing worst itch imaginable (Kimball et al, 2016)."|Baseline and Week 16|"The Full Analysis Set (FAS) consisted of all participants in the RS who received at least 1 dose of the study medication and had valid efficacy assessments for Baseline and for at least 1 post-Baseline visit.~Missing data were handled using the last observation carried forward (LOCF) method for the Itch Numeric Rating Scale."|||Scores on a scale||Standard Error|Least Squares Mean
2540350|NCT03051217|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16|"This Outcome Measure applied to participants with moderate to severe chronic plaque Psoriasis (PSO).~The DLQI is a subject-reported questionnaire designed for use in adult participants with PSO.~The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL). This instrument asked participants about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 30 with higher scores indicating lower HRQoL. A higher than or equal to (>=) 4-point change in the DLQI score (DLQI response) has been reported to be meaningful for the patient (within-patient minimal important difference Basra et al, 2015) a DLQI absolute score of lower than or equal to (=<) 1 indicates DLQI remission (i.e., no or small impact of the disease on HRQoL)."|Baseline and Week 16|"The Full Analysis Set (FAS) consisted of all participants in the RS who received at least 1 dose of the study medication and had valid efficacy assessments for Baseline and for at least 1 post-Baseline visit.~Missing data were handled using the last observation carried forward (LOCF) method for the DLQI."|||Scores on a scale||Standard Error|Least Squares Mean
2540351|NCT03051217|Secondary|Percentage of Subjects Achieving a 90 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16|The PASI90 response assessments were based on at least 90 % improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.|Week 16|"The Full Analysis Set (FAS) consisted of all participants in the RS who received at least 1 dose of the study medication and had valid efficacy assessments for Baseline and for at least 1 post-Baseline visit.~Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation."|||percentage of participants|||Number
2540352|NCT03051217|Secondary|Percentage of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2-category Improvement) at Week 16|"This Outcome Measure applied to participants with moderate to severe chronic plaque Psoriasis (PSO).~The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe."|Week 16|"The Full Analysis Set (FAS) consisted of all participants in the RS who received at least 1 dose of the study medication and had valid efficacy assessments for Baseline and for at least 1 post-Baseline visit.~Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation."|||percentage of participants|||Number
2540353|NCT03051217|Primary|Percentage of Subjects Achieving a 75 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16|The PASI75 response assessments were based on at least 75 % improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.|Week 16|"The Full Analysis Set (FAS) consisted of all participants in the Randomized Set (RS) who received at least 1 dose of the study medication and had valid efficacy assessments for Baseline and for at least 1 post-Baseline visit.~Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation."|||percentage of participants|||Number
2540354|NCT03051165|Secondary|Change in Soluble Urokinase-type Plasminogen Activator Receptor (suPAR)|To assess changes in the serum biomarker profile, blood will be collected from participants to be stored for future analyses of a variety of biochemical factors related to cardiovascular function. Soluble urokinase-type plasminogen activator receptor (suPAR) is a marker for disease status by indicating the degree of activation of the immune system. Higher concentrations indicate inflammation and are associated with an increased risk of mortality.|Baseline, Day 105, Day 137|Blood for serum biomarker assessments was not collected for any participants at any study visit.||||||
2540357|NCT03051165|Secondary|Change in Fibrin Degradation Products|To assess changes in the serum biomarker profile, blood will be collected from participants to be stored for future analyses of a variety of biochemical factors related to cardiovascular function. Fibrin degradation products are produced by of clot degeneration. Plasma fibrin degradation products increase following clot formation.|Baseline, Day 105, Day 137|Blood for serum biomarker assessments was not collected for any participants at any study visit.||||||
2540358|NCT03051165|Secondary|Change in C-reactive Protein|To assess changes in the serum biomarker profile, blood will be collected from participants to be stored for future analyses of a variety of biochemical factors related to cardiovascular function. C-reactive protein is produced by the liver and increased concentrations are found when inflammation is present in the body.|Baseline, Day 105, Day 137|Blood for serum biomarker assessments was not collected for any participants at any study visit.||||||
2540359|NCT03051165|Secondary|Change in 24-hour Ambulatory Blood Pressure|To measure 24-hour ambulatory blood pressure, participants wear a watch like device on one arm which records blood pressure throughout the day.|Baseline, Day 105, Day 137|One participant completed the 24-hour ambulatory blood pressure Baseline assessment.|||mm/Hg||Standard Deviation|Mean
2540360|NCT03051165|Secondary|Change in Peripheral Arterial Stiffness|Recordings of blood flow through the artery in the wrist will be obtained with application of a probe applied to the skin. Participants will be seated or lying down for this test which takes approximately 10 minutes. Increased arterial stiffness is associated with an increased risk of cardiovascular events.|Baseline, Day 105, Day 137|Peripheral arterial stiffness assessment was not performed for any participants at any study visit.||||||
2540361|NCT03051165|Secondary|Change in Flow Mediated Dilation|Flow mediated dilation is a method to assess endothelial function using an ultrasound device to take measurements of the artery at the elbow. Blood vessel diameter is measured before and after blood pressure cuff release and flow mediated dilation is the percent of change between the baseline and post cuff release measurements. A lower measurement of dilation corresponds with an increased risk for cardiovascular events.|Baseline, Day 105, Day 137|One participant completed the flow mediated dilation assessment at Baseline and Day 105.|||percentage of baseline arterial diameter||Standard Deviation|Mean
2540362|NCT03051165|Primary|Change in Peripheral Arterial Tonometry (PAT)|Peripheral arterial tonometry (PAT) is a method for measuring endothelial dysfunction in a non-invasive way. Blood flow is measured in the fingertips following compression with an inflatable cuff on the upper arm. Participants will lay on their backs with a probe placed on the finger of each hand. The probes are attached to a computer that records finger blood flow. The finger probes will continuously record the blood flow in the fingertips for 10 minutes|Baseline, Day 105, Day 137|PAT assessment was not performed for any participants at any study visit.||||||
2540363|NCT03051100|Secondary|Number of Participants With LDL-C Reduction ≥50% From Baseline at Week 6|If LDL-C was measured (i.e., if TG was >400 mg/dL or LDL-C was <50 mg/dL), the measured values were used in the analysis.|Baseline; Week 6|Modified Intent-to-Treat Population. Only those participants with data available were analyzed.|||Participants|||Count of Participants
2540364|NCT03051100|Secondary|Number of Participants With LDL-C <70 mg/dL at Week 6|Analysis was based on LOCF values. If LDL-C was measured (i.e., if TG was >400 mg/dL or LDL-C was <50 mg/dL), the measured values were used in the analysis.|Week 6|Modified Intent-to-Treat Population. Only those participants with data available were analyzed.|||Participants|||Count of Participants
2540365|NCT03051100|Secondary|Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 6|Percent change is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the predose Day 1/Week 0 (Treatment Visit 1) value. If only one value is available either at Week -1 (Screening Visit 2) or Week 0 (Treatment Visit 1), then that value is used as Baseline. Missing values were imputed using LOCF, with only post-Baseline values carried forward.|Baseline; Week 6|Modified Intent-to-Treat Population. Only those participants with data available were analyzed.|||percent change||Inter-Quartile Range|Median
2540366|NCT03051100|Secondary|Percent Change From Baseline in Lipid Profile Parameters at Week 6|Percent change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the mean of the values from Week -1 (Screening Visit 2) and predose Day 1/Week 0 (Treatment Visit 1). Baseline apolipoprotein B (apoB) was measured only at predose/Day 1. Percent change from Baseline was analyzed using analysis of covariance (ANCOVA) with treatment group as a factor and Baseline value as a covariate. Missing values were imputed using LOCF, with only post-Baseline values carried forward. non-HDL-C, non-high-density lipoprotein cholesterol; TC, total cholesterol; TG, triglycerides; HDL-C, high-density lipoprotein cholesterol.|Baseline; Week 6|Modified Intent-to-Treat Population. Only those participants with data available were analyzed.|||percent change||Standard Error|Least Squares Mean
2540367|NCT03051100|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 6|Percent change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the mean of the values from Week -1 (Screening Visit 2) and predose Day 1/Week 0 (Treatment Visit 1). Percent change from Baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group as a factor and Baseline value as a covariate. Missing LDL-C values were imputed using last observation carried forward (LOCF), with only post-Baseline values carried forward. If LDL-C was measured (i.e., if TG was >400 mg/dL or LDL-C was <50 mg/dL), the measured values were used in the analysis.|Baseline; Week 6|Modified Intent-to-Treat Population: all randomized participants who received at least 1 dose of investigational medicinal product (IMP) and who had a Baseline assessment and at least 1 post-Baseline assessment, excluding any assessment taken more than 2 days after a dose of IMP. Only those participants with data available were analyzed.|||percent change||Standard Error|Least Squares Mean
2540368|NCT03050918|Secondary|Mortality|All cause mortality|30 days|Thirty-day mortality data was retrieved from the EHR data repository after a 120-day lag to capture delayed reporting.|||Participants|||Count of Participants
2540369|NCT03050918|Secondary|Number of Patient Received Discharge Plan Implementation Assistance|Need for assistance in implementing discharge plan|30 days|Discharge plan implementation assistance was offered as part of the intervention and not to the control group.|||Participants|||Count of Participants
2540370|NCT03050918|Secondary|VUMC Emergency Department (ED) Visits|All cause ED visits following discharge|30 days||||ED visits|||Number
2540371|NCT03050918|Secondary|Patient Satisfaction: Likelihood to Recommend the Facility|Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Scale range is 0-3. Higher scores indicate more patient satisfaction.|Within 60 days of Discharge|Patient experience data were retrieved from the hospital quality and patient safety office at 60 days, but assessment was administered via a survey sent to patients at their home after hospital discharge. Scores are based on the number of surveys returned|||score on a scale||Standard Deviation|Mean
2540372|NCT03050918|Secondary|Patient Satisfaction: Hospital Experience (Top Box Rating)|Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Number of patients that rated the Hospital Experience as 9. Scale range is 0-9. Higher scores indicate more patient satisfaction.|Within 60 days of Discharge|Patient experience data were retrieved from the hospital quality and patient safety office at 60 days, but assessment was administered via a survey sent to patients at their home after hospital discharge. Scores are based on the number of surveys returned|||Participants|||Count of Participants
2540373|NCT03050918|Secondary|Patient Satisfaction: Likelihood to Recommend the Facility (Top Box Rating)|Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Number of patients that reported a score of 3. Range is 0-3 with 3 being highest satisfaction.|Within 60 days of Discharge|Patient experience data were retrieved from the hospital quality and patient safety office at 60 days, but assessment was administered via a survey sent to patients at their home after hospital discharge. Scores are based on the number of surveys returned.|||Participants|||Count of Participants
2540374|NCT03050918|Secondary|Patient Satisfaction: Experience|Measured as mean Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) patient satisfaction scores. Higher scores indicate more patient satisfaction. Range is 0-9 with 9 being the most satisfied.|Within 60 days of Discharge|Patient experience data were retrieved from the hospital quality and patient safety office at 60 days, but assessment was administered via a survey sent to patients at their home after hospital discharge. Scores are based on the number of surveys returned|||score on a scale||Standard Deviation|Mean
2540375|NCT03050918|Primary|Number of Participants With In-patient Re-admissions|Number of participants with in-patient re-admissions|30 days||||Participants|||Count of Participants
2540376|NCT03050775|Secondary|Estimated Blood Loss|The estimated blood loss per case was determined by the anesthesia provider by measuring the volume of blood in the suction canister while taking into account the amount of irrigation solution used.|duration of surgery|One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.|||milliters||Inter-Quartile Range|Median
2540377|NCT03050775|Secondary|Number of Participants With Transfusion Within 48 Hours of Surgery|Requirement of blood transfusion within 48 hours of surgery|Within 48 hours of surgery|One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.|||Participants|||Count of Participants
2540378|NCT03050775|Secondary|Overall Post-operative Temperature|Temperature at Post Anesthesia Care Unit (PACU) arrival.|PACU arrival|"One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.~Data was obtained from 32 subjects in the treatment group."|||degrees Celsius||Standard Deviation|Mean
2540379|NCT03050775|Secondary|Hospital Length of Stay|Number of days in the hospital|Surgery to hospital discharge|One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.|||number of days||Inter-Quartile Range|Median
2540380|NCT03050775|Secondary|Number of Subjects With Post-operative Shivering|Shivering in the post-anesthesia care unit will be assessed using the Bedside Shivering Assessment Scale. This is a 4 point scale and rate shivering as the following: absent, mild, moderate, or severe. Only the highest degree of patient shivering was used in the analysis.|Approximately 2 hours after completion of the surgery|One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.|||Participants|||Count of Participants
2540381|NCT03050775|Secondary|Intraoperative Core Temperatures Post-induction|Core body temperature will be taken in the esophagus after general anesthesia induction.|Approximately 30 minutes, 60 minutes, 120 minutes post-induction of general anesthesia|"One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.~Data was obtained from 33 subjects in the treatment group at 60 minutes post-induction."|||degrees Celsius||Standard Deviation|Mean
2540382|NCT03050775|Primary|Core Body Temperature|Core body temperature will be taken in the esophagus. The last recorded esophageal temperature will be used for surgeries not reaching 3 hours duration.|Approximately four hours post-induction of general anesthesia (or last recorded temperature)|One subject in the standard group was not included in any of the analyses as this subject's intraoperative temperature was unavailable as part of the anesthetic record.|||degrees Celsius||Standard Deviation|Mean
2540383|NCT03050619|Secondary|Baseline Characteristics (as Measured by Concomitant Medications) of Patients Starting Index Prescriptions Off-label|Baseline characteristics of patients (as measured by concomitant medications) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category. Subjects taking medication up to 60 days before index date are presented.|Baseline|All patients older than 18 years with unspecified DM who initiated treatment with empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Percentage of Participants|||Number
2552322|NCT02796092|Secondary|Total Intervention Duration|Total time length of the procedure, from puncture to compression (in minutes)|Intraoperative||||minutes||Standard Deviation|Mean
2540384|NCT03050619|Secondary|Baseline Characteristics (as Measured by Comorbidities) of Patients Starting Index Prescriptions Off-label|Baseline characteristics of patients (as measured by comorbidities) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.|Baseline|All patients older than 18 years with unspecified DM who initiated treatment with empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Percentage of Participants|||Number
2540385|NCT03050619|Secondary|Baseline Characteristics (as Measured by Creatinine Serum (SCR)) of Patients Starting Index Prescriptions Off-label|Baseline characteristics of patients (as measured by creatinine serum (SCR)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.|Baseline|All patients older than 18 years with unspecified DM who initiated treatment with empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Micromoles per liter (umol/L)||Standard Deviation|Mean
2540386|NCT03050619|Secondary|Baseline Characteristics (as Measured by Estimated Glomerular Filtration Rate (eGFR)) of Patients Starting Index Prescriptions Off-label|Baseline characteristics of patients (as measured by estimated glomerular filtration rate (eGFR)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.|Baseline|All patients older than 18 years with unspecified DM who initiated treatment with empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Milliliters per minute (ml/min)||Standard Deviation|Mean
2540387|NCT03050619|Secondary|Baseline Characteristics (as Measured by Laboratory Tests) of Patients Starting Index Prescriptions Off-label|Baseline characteristics of patients (as measured by laboratory tests) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.|Baseline|All patients older than 18 years with unspecified DM who initiated treatment with empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Millimole per liter (mmol/L)||Standard Deviation|Mean
2540388|NCT03050619|Secondary|Baseline Characteristics (as Measured b Yglycated Haemoglobin (HbA1c)) of Patients Starting Index Prescriptions Off-label|Baseline characteristics of patients (as measured by glycated haemoglobin (HbA1c)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.|Baseline|All patients older than 18 years with unspecified DM who initiated treatment with empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Millimole per mole (mmol/mol)||Standard Deviation|Mean
2540389|NCT03050619|Secondary|Baseline Characteristics (as Measured by Life Style Factors (Blood Pressure)) of Patients Starting Index Prescriptions Off-label|Baseline characteristics of patients (as measured by life style factors (blood pressure)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.|Baseline|All patients older than 18 years with unspecified DM who initiated treatment with empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2540390|NCT03050619|Secondary|Baseline Characteristics (as Measured by Life Style Factors (BMI)) of Patients Starting Index Prescriptions Off-label|Baseline characteristics of patients (as measured by life style factors (BMI)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label is presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.|Baseline|All patients older than 18 years with unspecified DM who initiated treatment with empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Kilogram per square meter (kg/m2)||Standard Deviation|Mean
2540391|NCT03050619|Secondary|Baseline Characteristics (as Measured by Life Style Factors (Smoking and Alcohol Use)) of Patients Starting Index Prescriptions Off-label|Baseline characteristics of patients (as measured by life style factors (smoking and alcohol use)) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category. NA= NR (Not Reported) (variables for which patient counts were <5)|Baseline|All patients older than 18 years with unspecified DM who initiated treatment with empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Percentage of Participants|||Number
2540392|NCT03050619|Secondary|Baseline Characteristics (as Measured by Demographics) of Patients Starting Index Prescriptions Off-label|Baseline characteristics of patients (as measured by demographics) who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) off-label are presented. Use of empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs in other types of diabetes (other than T2DM) or without diabetes or in people younger than 18 years old or in women during pregnancy or during breastfeeding is considered as off-label. As per CPRD guideline, no cell that contains <5 events should be reported to protect patient confidentiality. Since empagliflozin group reported <5 events for all off-label categories except for unspecified DM therefore baseline characteristics are presented for only unspecified DM category.|Baseline|All patients older than 18 years with unspecified DM who initiated treatment with empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Percentage of Participants|||Number
2540393|NCT03050619|Secondary|Extent of Off-label Use|To assess off-label use the number of study participants without a recorded diagnosis of T2DM was calculated for each exposure category (people with other types of diabetes, people without diabetes, people younger than 18 years old, and women during pregnancy and breastfeeding). For the assessment of drug use during the pregnancy and breastfeeding period, the look-back period was 270 days (9 months) before and including the index date. To assess the use in pediatric population, the study participants were stratified by age into adults (≥18 years of age) and pediatrics (<18 years of age).|Baseline|All patients (without any age restriction), with or without a recorded diagnosis of diabetes, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Participants|||Number
2540394|NCT03050619|Primary|Baseline Characteristics of Adults (as Measured by Concomitant Medications) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK|Baseline characteristics of adults (as measured by concomitant medications) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented. Subjects taking medication up to 60 days before index date are presented.|Baseline|All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Percentage of Participants|||Number
2540395|NCT03050619|Primary|Baseline Characteristics of Adults (as Measured by Comorbidities) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK|Baseline characteristics of adults (as measured by comorbidities) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented.|Baseline|All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Percentage of Participants|||Number
2540396|NCT03050619|Primary|Baseline Characteristics of Adults (as Measured by Creatinine Serum (SCR)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK|Baseline characteristics of adults (as measured by by creatinine serum (SCR)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of creatinine serum (SCR) measured is presented along with number of subjects with available data.|Baseline|All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Micromoles per liter (umol/L)||Standard Deviation|Mean
2540899|NCT03039088|Secondary|Evaluation of the Concordance Existing Between the Current Recommendations for the Initiation of Anti-TNF in Non-radiographic Axial SpA and the Daily Practice as Represented by This Study.||At baseline and at 12 weeks after TNF alpha blockers initiation|||||||
2540397|NCT03050619|Primary|Baseline Characteristics of Adults (as Measured by Estimated Glomerular Filtration Rate (eGFR)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK|Baseline characteristics of adults (as measured by estimated glomerular filtration rate (eGFR)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of estimated glomerular filtration rate (eGFR) measured is presented along with number of subjects with available data.|Baseline|All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Milliliters per minute (ml/min)||Standard Deviation|Mean
2540398|NCT03050619|Primary|Baseline Characteristics of Adults (as Measured by Laboratory Tests) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK|Baseline characteristics of adults (as measured by laboratory tests) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented. Mean and standard deviation (SD) of total cholesterol (TC), high-density lipoproteins level (HDL), Low-density lipoprotein level (LDL) and triglyceride level (TG) measured are presented along with number of subjects with available data.|Baseline|All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Millimole per liter (mmol/L)||Standard Deviation|Mean
2540399|NCT03050619|Primary|Baseline Characteristics of Adults (as Measured by Glycated Haemoglobin (HbA1c)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK|Baseline characteristics of adults (as measured by glycated haemoglobin (HbA1c)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of glycated haemoglobin (HbA1c) measured is presented along with number of subjects with available data.|Baseline|All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Millimole per mole (mmol/mol)||Standard Deviation|Mean
2540400|NCT03050619|Primary|Baseline Characteristics of Adults (as Measured by Life Style Factors (Blood Pressure)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK|Baseline characteristics of adults (as measured by life style factors (blood pressure)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) measured is presented along with number of subjects with available data.|Baseline|All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2540401|NCT03050619|Primary|Baseline Characteristics of Adults (as Measured by Life Style Factors (BMI)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK|Baseline characteristics of adults (as measured by life style factors (BMI)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) is presented. Mean and standard deviation (SD) of body mass index (BMI) measured is presented along with number of subjects with available data.|Baseline|All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Kilogram per square meter (kg/m2)||Standard Deviation|Mean
2540402|NCT03050619|Primary|Baseline Characteristics of Adults (as Measured by Life Style Factors (Smoking and Alcohol Use)) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK|Baseline characteristics of adults (as measured by life style factors (smoking and alcohol use)) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented. NA= NR (Not Reported) (variables for which patient counts were <5)|Baseline|All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Percentage of Participants|||Number
2540403|NCT03050619|Primary|Baseline Characteristics of Adults (as Measured by Demographics) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK|Baseline characteristics of adults (as measured by demographics) with a recorded diagnosis of T2DM who initiated index prescriptions (empagliflozin, other SGLT-2i or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists)) are presented.|Baseline|All patients (older than 18 years), with a recorded T2DM, who initiated treatment with empagliflozin, other SGLT-2i, or other commonly used non-insulin GLDs (comprising DPP-4i, metformin, SU and GLP-1 agonists) between 01 August 2014 and 01 September 2015 were included.|||Percentage of Participants|||Number
2540404|NCT03050541|Secondary|Probability of Accurately Recognizing Visual Stimuli|"After the cued recollection task, all of the pictures were presented to participants (i.e., the ones that they had seen, as well as the ones that were not seen). Participants were then asked, Did you see this picture? Hit and false alarm rates were calculated, and memory accuracy was measured as hits minus false alarms."|90 minutes into Session 2||||probability||Standard Deviation|Mean
2540405|NCT03050541|Primary|Probability of Accurately Recalling Visual Stimuli|"During encoding, participants were presented with labels that were sometimes followed by pictures. During the first memory test, participant were presented again with all of the labels and asked, Did you see this picture? Hit and false alarm rates were then calculated, and memory accuracy was measured by hits minus false alarms."|90 minutes into Session 2||||probability||Standard Deviation|Mean
2540900|NCT03039088|Secondary|Pourcentage of Patients With Fibromyalgia (as Co-morbidity or as Single Disease)||At 12 weeks after TNF alpha blockers initiation|||||||
2540406|NCT03050372|Secondary|Concentration After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)|Participants rate after each night their ability to concentrate on a 0-100mm continuous scale; 0mm not at all; 100mm very/a lot. This is a subjective proxy measure for a restorative sleep / sleep quality.|Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS|12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 & 4/5, each pair either sham or active.|||units on a scale (0-100mm)||Standard Deviation|Mean
2540407|NCT03050372|Secondary|Fatigue After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)|Participants rate after each night how fatigued they feel on a 0-100mm continuous scale; 0mm not at all; 100mm very/a lot.|Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS|12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 & 4/5, each pair either sham or active.|||units on a scale (0-100mm)||Standard Deviation|Mean
2540408|NCT03050372|Secondary|Number of Awakenings (#Awake) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)|Number of Awakenings (#awake) is the integer number of nocturnal awakenings after initial sleep onset, i.e. a count.|Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS|12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 & 4/5, each pair either sham or active.|||awakenings||Standard Deviation|Mean
2540409|NCT03050372|Primary|MUSC Sleep Quality Score (SQS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)|MUSC Sleep Quality Score (SQS) is assessed after each night as a subjective measure; participants self-rate their perceived sleep quality on a 0-6 scale where 0 is associated with extremely poor sleep quality and 6 is associated with extremely good sleep quality.|Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS|12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 & 4/5, each pair either sham or active.|||score on a scale (0-6)||Standard Deviation|Mean
2540410|NCT03050372|Primary|Ease of Sleep (EOS) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)|Ease of Sleep (EOS) is assessed after each night as a subjective measure; participants self-rate their ease to fall asleep on a visual analog scale 0-100mm where 0mm is associated with not easy at all (no sleep) and 100mm is associated with no problems to fall asleep. EOS is a proxy measure for a participants sleepiness.|Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS|12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 & 4/5, each pair either sham or active.|||units on a scale (0-100mm)||Standard Deviation|Mean
2540411|NCT03050372|Primary|Sleep Efficiency (SE) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)|Sleep Efficiency (SE) is an objective measure of sleep quality derived from polysomnography (PSG); it is a unitless measure defined as the total sleep time (TST) divided by total time in bed (TiB); it can theoretically range from 0 (no sleep at all) to 1 (slept the entire time in bed). Values close to zero indicate very little time spent sleeping while values close to one indicate a large sleep utilization while in bed.|Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS|12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 & 4/5, each pair either sham or active.|||unitless ratio (0 to 1)||Standard Deviation|Mean
2540412|NCT03050372|Primary|Total Sleep Time (TST) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)|Total Sleep Time is the total time spent sleeping (non-wake stages S1-S5) in minutes; validated objective measure directly extracted from polysomnography (PSG).|Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS|12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 & 4/5, each pair either sham or active.|||minutes||Standard Deviation|Mean
2540425|NCT03050320|Secondary|Change in Self-reported Upper Extremity Pain|The Disabilities of the Arm Shoulder and Hand is a 30-item questionnaire addressing upper extremity physical function and symptoms. The DASH is suitable for people with any upper limb musculoskeletal disorders and can also monitor changes in severity of symptoms and functional abilities over time. Each item is scored from 1 (no difficulty) to 5 (unable). Total scores range from 0 to 100, with higher scores indicating more upper limb problems.|Weeks 1 and 13||||Units on a scale||Standard Deviation|Mean
2540897|NCT03039179|Secondary|"Pain (Score on the Numeric Rating Scale)"|"Pain Score on the Numeric Rating Scale > 3. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain."|up to the first 3 days post intervention||||Participants|||Count of Participants
2540413|NCT03050372|Primary|Wake After Sleep Onset (WASO) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)|Total time awake after initial sleep onset in minutes; validated objective measure directly extracted from polysomnography (PSG); we average measures from both consecutive nights under each of the two interventions (Sham or Active LFMS)|Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS|12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 & 4/5, each pair either sham or active.|||minutes||Standard Deviation|Mean
2540414|NCT03050372|Primary|Sleep Onset Latency (SOL) After Sham vs. Active LFMS (Each Averages of Two Consecutive Nights); and Difference From Baseline (Adaptation Night)|SOL is the time of transition from wake to sleep (non-REM S1) measured in minutes; a validated objective measure extracted directly from full-night polysomnography (PSG). SOL of 0-5min is associated with severe sleep deprivation; 5-10min is moderate sleep debt; 10-15min indicates mild sleep debt; 15-20min is little-to-no sleep debt; and >20min is considered to be associated with no sleep debt.|Each night (5 nights total): Baseline (adaptation night #1), First Intervention (nights #2,#3), Second Intervention (nights #4,#5); Interventions randomized Sham or Active LFMS|12 subjects completed the adaptation night (Baseline); 1 subject was then excluded due to mild sleep apnea; 11 subjects completed treatment (active or sham) nights 1/2; 1 subject moved out of State (received sham in night 1/2); 10 subjects completed all 5 nights: adaptation night and intervention nights 2/3 & 4/5, each pair either sham or active.|||minutes||Standard Deviation|Mean
2540415|NCT03050320|Secondary|Change in Arthritis-related Self-Efficacy|The Arthritis Self-Efficacy Scale (ASES) measures arthritis-specific beliefs regarding perception of performance on certain tasks to cope with the disease. The ASES is measured using 20 questions on a 10-100 scale with respect to three main areas: pain management (5 questions), physical function (9 questions), and other symptoms (6 questions). Each question is scored from 10 (very uncertain), to 100 (very certain), in 10-point increments. The minimum score for each subscale is 10, and the maximum score for each subscale is 100. The scores from each subscale are averaged to produce a normalized total score. Scores closer to 100 indicate greater certainty that a participant can cope with a particular task as a consequence of their disease.|Weeks 1 and 13||||Units on a scale||Standard Deviation|Mean
2540416|NCT03050320|Secondary|Change in Depressive Symptoms|Depression will be assessed with the Centre of Epidemiological Studies Depression (CES-D) Scale, a 20-item scale developed for the general population with emphasis on affect. Elements of affect include mood, guilt, worthlessness, helplessness, appetite, and sleep. Each item is scored from 0 (rarely or none of the time), to 3 (most of the time). The items are summed to produce a total score between 0 and 60 with a score of 16 or higher indicating depression.|Weeks 1 and 13||||Units on a scale||Standard Deviation|Mean
2540417|NCT03050320|Secondary|Change in Work Ability|The Work Ability Index (WAI) is a widely-used self-report questionnaire that evaluates a worker's capacity to perform a job accounting for their physical and mental well-being in addition to the demands of their job. The WAI consists of seven dimensions including current work ability relative to life-time best, work ability related to job demands, number of current physician-diagnosed health conditions, estimated work impairment due to the conditions, sick leave over the past year, own prognosis, and mental resources. Total scores range from 7 to 49 and can fall under one of four classifications: poor work ability that should be restored (7-27), moderate work ability that should be improved (28-36), good work ability that should be supported (37-43), and excellent work ability that should be maintained (44-49). The WAI produces reliable data.|Weeks 1 and 13||||Units on a scale||Standard Deviation|Mean
2540418|NCT03050320|Secondary|Change in Resilience|Resilience will be measured using the Resilience Scale 25 Survey, which is a 25-item questionnaire designed to evaluate a participants ability to adapt to stress and adversity. The test is scored out of 175 (scores ranging from 25 to 175), with higher scores indicating higher resilience.|Weeks 1 and 13||||Units on a scale||Standard Deviation|Mean
2540419|NCT03050320|Secondary|Change in Mobility Performance (30-second Chair Stand Test)|Mobility performance will be measured using the 30-second Chair Stand Test. This test measures the number of times participants can rise and lower from a standard height chair, without using arm rests, in a 30-second period.This measure has produced reliable and valid data in persons with knee OA.|Weeks 1 and 13|Data from one individual from the No Exercise group was not collected for this measure due to an unrelated back injury.|||Number of chair stands||Standard Deviation|Mean
2540420|NCT03050320|Secondary|Change in Mobility Performance (Stair Ascent and Descent)|Mobility performance will be measured using the Stair Ascent and Descent Test. For this test, the time taken to ascend, as well as descend nine stairs is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.|Weeks 1 and 13|Data from one individual from the No Exercise group was not collected for this measure due to an unrelated back injury.|||Seconds||Standard Deviation|Mean
2540421|NCT03050320|Secondary|Change in Mobility Performance (Six-Minute Walk Test)|Mobility performance will be measured using the Six-Minute Walk Test (6MWT). For this test, participants are instructed to walk as far as possible in 6 minutes. The distance covered in 6 minutes is recorded in metres. This measure has produced reliable and valid data in persons with knee OA.|Weeks 1 and 13|Data from one individual from the No Exercise group was not collected for this measure due to an unrelated back injury.|||Meters||Standard Deviation|Mean
2540422|NCT03050320|Secondary|Change in Cardiovascular Fitness|Cardiovascular fitness will be calculated using the Single Stage Treadmill Walking Test. Predictions of VO2max will be made from heart rate (measured with a heart rate monitor), walking speed, age and gender.|Weeks 1 and 13||||mL/kg/min||Standard Deviation|Mean
2540423|NCT03050320|Secondary|Change in Grip Strength|Grip strength will be assessed using a Jamar hand dynamometer. The hand dynamometer will be set to a fixed position and all values of grip force will be expressed in kg.|Weeks 1 and 13||||Kg of force||Standard Deviation|Mean
2540424|NCT03050320|Secondary|Change in Isometric Knee Extensor and Flexor Strength|The peak torque developed during knee extension and flexion during a maximum isometric contraction will be measured by use of a ergoFET hand-held dynamometer.|Weeks 1 and 13|Data from one individual from the No Exercise group was not collected for this measure due to an unrelated back injury.|||Newton*meters/kg||Standard Deviation|Mean
2540426|NCT03050320|Secondary|Change in Self-reported Knee and Hip Pain|Change in self-reported knee and hip pain will be assessed with 3 valid and reliable questionnaires: the Knee injury and Osteoarthritis Outcome Score (KOOS), the Hip disability and Osteoarthritis Outcome Score (HOOS), and the Intermittent and Constant Osteoarthritis Pain (ICOAP) score. The KOOS and HOOS pain scores represent a normalized score from 0 (extreme symptoms) to 100 (no symptoms). KOOS and HOOS scores closer to 100 indicate fewer symptoms. The ICOAP consists of two sub-scales: constant pain (5 items) and intermittent pain (6 items). The score from each subscale represents a normalized score from 0 (no pain) to 100 (extreme pain). ICOAP scores closer to 0 indicate less pain. The items from each subscale are averaged to produce a normalized ICOAP total score, ranging from 0 (no pain) to 100 (extreme pain).|Weeks 1 and 13||||Units on a scale||Standard Deviation|Mean
2540427|NCT03050320|Primary|Change in Lower Extremity Functional Scale|The Lower Extremity Function Scale (LEFS) consists of 20 items, on an adjectival scale, that assess difficulty during mobility tasks ranging from transfers to running. Each item is scored from 0 (extreme difficulty or unable to perform activity), to 4 (no difficulty to perform activity). The minimum possible score is 0, and the maximum possible score is 80. Scores closer to 80 represent better self-reported physical function. It is reliable and valid in knee OA and has superior sensitivity to change compared to similar measures|Weeks 1 and 13||||Units on a scale||Standard Deviation|Mean
2540428|NCT03050294|Secondary|Psoriasis Area and Severity Index|The Psoriasis Area Severity Index (PASI) is an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected areas (head, arms, trunk, and legs). The severity of three clinical signs (erythema, induration and desquamation) are on a scale from 0 to 4 (from absent to very severe). An area and severity score for each region is calculated by multiplying the area score by the severity score. The score range is 0-72, with higher scores denoting worse outcomes.|2 weeks||||units on a scale||Standard Deviation|Mean
2540429|NCT03050294|Secondary|Pruritus Visual Analog Scale- Psoriasis|"The Pruritus VAS is a scale consisting of a 10cm long line and a single question. The left end point represents no itch (score of 0) and the right end point the worst imaginable itch (score of 10)."|2 weeks||||units on a scale||Standard Deviation|Mean
2540430|NCT03050294|Secondary|Pruritus Visual Analog Scale- Atopic Dermatitis|"The Pruritus VAS is a scale consisting of a 10cm long line and a single question. The left end point represents no itch (score of 0) and the right end point the worst imaginable itch (score of 10)."|1 week||||units on a scale||Standard Deviation|Mean
2540431|NCT03050294|Secondary|Eczema Area and Severity Index- Atopic Dermatitis|Eczema Area and Severity Index (EASI): Disease severity will be assessed by a physician with the Eczema Area and Severity Index (EASI). This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions (which differs for adults and children under 7) and scores erythema, excoriation, induration/papulation, and lichenification. The total scores range from 0-72. Higher scores represent more severe eczema.|1 week||||units on a scale||Standard Deviation|Mean
2540432|NCT03050294|Secondary|Total Lesion Severity Score-Psoriasis|The total lesion severity score measures scaling, erythema, and plaque elevation. The score range is 0-15, with higher scores denoting worse outcomes.|2 weeks||||units on a scale||Standard Deviation|Mean
2540433|NCT03050294|Secondary|Total Lesion Severity Score- Atopic Dermatitis|The total lesion severity score measures scaling, erythema, and plaque elevation. The score range is 0-15, with higher scores denoting worse outcomes.|1 week||||units on a scale||Standard Deviation|Mean
2540434|NCT03050294|Primary|Investigator Global Assessment- Psoriasis|Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease|2 weeks||||units on a scale||Standard Deviation|Mean
2540435|NCT03050294|Primary|Investigator Global Assessment- Atopic Dermatitis|Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease|1 week||||units on a scale||Standard Deviation|Mean
2540436|NCT03050203|Secondary|Length of Stay|number of days spent in hospital|up to 2 weeks|||||||
2540437|NCT03050203|Secondary|"Pain (Score on the Numeric Rating Scale)"|"Pain Score on the Numeric Rating Scale. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain."|up to the first 3 days post intervention|||||||
2540438|NCT03050203|Secondary|Blood Loss|Levels of hemoglobin and hematocrit intraoperative (gas analysis before and after surgery) compared to hemoglobin and hematocrit before surgery and number of blood transfusions both intra- and postoperative.|up to 2 weeks|||||||
2540439|NCT03050203|Secondary|Numbers of Materials Wasted|amount of open sterile materials not used|up to the first day post intervention|||||||
2540440|NCT03050203|Secondary|Postoperative Complications|number of early wound infection|up to 2 weeks|||||||
2540441|NCT03050203|Secondary|Surgery Time|from the incision to the patient's sutures (minutes)|up to the first day post intervention|||||||
2540442|NCT03050203|Primary|Soft Tissue Dissecting Time|minutes from the start of the dissection to complete bone cleaning|up to the first day post intervention||||minues||Standard Deviation|Mean
2540443|NCT03049852|Secondary|Corneal Pterygium Lesion Length Change From Baseline|The Corneal Pterygium Lesion Length is measured from digital images of the eye by an independent image reading center.|4 weeks|Modified Intent-to-Treat Population|||mm||Standard Deviation|Mean
2540444|NCT03049852|Primary|Ocular and General Safety and Tolerability|The ocular safety and tolerability are measured by biomicroscopy, ophthalmoscopy, intraocular pressure and visual acuity, and to assess general safety by physical exams, vital signs, clinical laboratory tests and adverse events reporting|One day|mITT|||participants|||Number
2540445|NCT03049852|Primary|Pterygium Vascularity Change Assessed Using the Pterygium Hyperemia Grading Scale|The primary efficacy variable is the change from baseline (Day 1) in severity grade of pterygium vascularity at Week 4. Pterygium vascularity intensity is based on color coordinates as measured by digital image analysis of pterygium photographs. The quantitative analysis of photographs using a 5-point Pterygium Hyperemia Grading Scale (0 = absent, 1 = trace, 2 = mild, 3 = moderate, 4 = severe) will be conducted at an independent image reading center.|Change from baseline at 4 weeks|Modified Intent-to-Treat Population|||grade||Standard Deviation|Mean
2540446|NCT03049501|Primary|Positive Aspects of Caregiving|An 11 item positive aspects of caregiving questionnaire was used to measure positive aspects of caregiving. Each item can be scored 0, 1, 2, 3, 4, negative 3 or negative 4. The total score ranging from negative 44 to 44. Higher score means more positive feelings towards caregiving.|Baseline, 6-mth follow-up and 12-mth follow-up|Follow up visits were not completed for all participants|||score on a scale||Standard Deviation|Mean
2540447|NCT03049501|Primary|Caregiver's Self-efficacy|A 15 item Caregiver's self efficacy questionnaire will be used to assess caregiver's self-efficacy. The questionnaire score ranges from 0-1500 percent with a lower percentage score indicating less efficacy.|Baseline, 6-mth follow-up and 12-mth follow-up|Follow up visits were not completed for all participants|||percentage of efficacy||Standard Deviation|Mean
2540448|NCT03049501|Primary|Caregiver's Self-report of Physical Health|SF 12 Health Survey was used to measure physical health of the caregiver. Scores ranges from 0 to 35 with lower score means less limitation to physical health.|Baseline, 6-mth follow-up and 12-mth follow-up|Follow up visits were not completed for all participants|||score on a scale||Standard Deviation|Mean
2540449|NCT03049501|Primary|Caregiver's Self Report of Self-care|A 13 Item self care questionnaire is used to measure caregivers self care. Each item can be scored as 0,1,negative 3 or negative 4. The total score ranging from negative 52 to 13. Higher score means better in keeping medical obligations to him/herself.|Baseline, 6-mth follow-up and 12-mth follow-up|Follow up visits were not completed for all participants|||score on a scale||Standard Deviation|Mean
2540450|NCT03049501|Primary|Caregiving Burden as Measured by Burden Inventory|Higher score means greater level of caregiver burden. Range (0-44)|Baseline, 6-mth follow-up and 12-mth follow-up|Follow up visits were not completed for all participants|||score on a scale||Standard Deviation|Mean
2540451|NCT03049501|Primary|Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D)|CES-D Scale ranges from 0 to 30 with higher scores indicating greater frequency of depressive symptoms.|Baseline, 6-mth follow-up and 12-mth follow-up|Follow up visits were not completed for all participants|||score on a scale||Standard Deviation|Mean
2540452|NCT03048383|Secondary|Adverse Events|We hypothesized that common minor events such as bruising and swelling at injection sites would occur equally for all treatment arms, but that no major adverse treatment effects would occur for any of the treatment arms. Major events are recorded here.|Up to 4 weeks post-treatment. Recorded at pre-treatment, 1 week, 2 weeks, and at 4 weeks.||||Adverse Events|||Number
2540453|NCT03048383|Primary|Change in Synkinesis Assessment Questionnaire (SAQ) Scores|"The previously validated instrument, Synkinesis Assessment Questionnaire (SAQ), was administered in order to evaluate patient-perceived severity of synkinesis. This instrument was used for each of the three treatment arms and change in scores from baseline were compared at each time point between arms.~SAQ scores are calculated as the sum of scores for 9 questions, which each is scored from 1 to 5, divided by 45 and multiplied by 100. The total score therefore can range from 20 to 100. Lower SAQ scores represent less severe facial synkinesis, and higher scores more severe. We report here the mean total SAQ score each group. For additional information on the SAQ for facial synkinesis see Mehta et al. published in Laryngoscope in May 2007 (PMID: 17473697)."|Up to 4 weeks post-treatment. Recorded at pre-treatment, 1 week, 2 weeks, and at 4 weeks.|The Synkinesis Assessment Questionnaire (SAQ) was used to assess severity of facial synkinesis for each group. Total SAQ scores can range from 20 to 100. Lower SAQ scores represent less severe facial synkinesis, and higher scores more severe.|||units on a scale||Standard Deviation|Mean
2540454|NCT03048058|Secondary|Dermatology Life Quality Index|Dermatology Life Quality Index (DLQI) for the impact of rosacea on everyday activities. The score range is 0-30 with higher scores having a larger effect on patient's life.|baseline and 6 months|No data was collected||||||
2540455|NCT03048058|Secondary|Quality of Life With Rosacea|Quality of life for rosacea was reported. The score range is 4-40 with higher scores denoting worse outcomes.|baseline and 6 months|Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months|||units on a scale||Standard Deviation|Mean
2540456|NCT03048058|Secondary|Patient Severity Assessment (PSA)|Patient Severity Assessment: Subject ratings of erythema with scale 0 - 4. 0 = face free of rosacea; 4 = My face has severe medium to large sized red inflamed bumps or pustules, My face has severe redness. Higher scores denotes worse outcomes.|baseline and 6 months|Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months|||units on a scale||Standard Deviation|Mean
2540457|NCT03048058|Secondary|Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities)|Change in overall Quality of Life as measured by the The Life Impact Survey. This measures the impact of rosacea and its treatment on life. The score range is 0-54 with higher scores denoting worse outcomes.|baseline and 6 months|Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months|||units on a scale||Standard Deviation|Mean
2540458|NCT03048058|Secondary|Clinician Erythema Assessment Scale|Clinician Erythema Assessment scale based on scale of 0-4 with 0 being no erythema and 4 being severe erythema with greater scores denoting a worse outcome.|baseline and 6 months|Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months|||units on a scale||Standard Deviation|Mean
2540459|NCT03048058|Secondary|Lesion Count|Change in total Lesion count|Baseline and 6 months|Only 7 participants in the gel and survey group and 6 in the control group reported data at 6 months|||count of lesions||Standard Deviation|Mean
2540460|NCT03048058|Primary|Adherence (% of Prescribed Doses That Were Actually Taken by the Subject)|To assess adherence to topical brimonidine for the treatment of rosacea as measured by MEMS caps. The result will be the % of prescribed doses that were actually taken by the subject|6 months||||percentage of medication use||Standard Deviation|Median
2540461|NCT03048006|Secondary|Image Quality|"Image quality was evaluated with a 5-step scale from excellent to very poor (excellent/very good; good; moderate; poor and very poor)"|During MRI procedure|Image quality was missing for 108 patients.|||Participants|||Count of Participants
2540462|NCT03048006|Secondary|Diagnostic Value|"Diagnostic value was evaluated by answering yes or no to the following question Were you able to make a diagnosis based on the test results ?"|During MRI procedure|Diagnostic value was missing for 77 patients.|||Participants|||Count of Participants
2540463|NCT03048006|Primary|Frequency of Adverse Events|The frequency of adverse events (serious and non-serious) that occurred following injection of Dotarem was recorded.|From the beginning of the MRI procedure to 30-60 min after||||adverse events|||Number
2540464|NCT03047551|Primary|Visual Analog Scale (VAS) Score for Patient Acceptability for Either Modality of Ultrasound|"To measure patient satisfaction after ultrasound examination, each participant will complete an acceptability questionnaire regarding the type of ultrasound she received (TVS or TAS) using a visual analog scale (VAS). The score is on a scale range of 0-100, with 0 being unacceptable and 100 being acceptable. Thus, higher scores are better."|1 day||||score on a scale||Full Range|Mean
2540465|NCT03047551|Primary|Percentage of Subjects in Each Ultrasound Group With Additional Testing|Evaluate how often a provider orders additional testing prior to medical abortion, but after either 1) patient history and TAS or 2) patient history and TVS.|1 day||||Participants|||Count of Participants
2540466|NCT03047447|Secondary|Ketones (Blood)|Ketones (blood) were measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for ketones (blood) at week 10 minus ketones (blood) at week 0.|10-weeks||||mmol/L||95% Confidence Interval|Mean
2540467|NCT03047447|Secondary|Body Fat Mass (Pounds of Body Fat)|BFM (body fat mass) was measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for BFM at week 10 minus BFM at week 0.|10-weeks||||pounds||95% Confidence Interval|Mean
2540468|NCT03047447|Secondary|BMI (Body Mass Index)|BMI (body mass index) was measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet group with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for BMI at week 10 minus BMI at week 0.|10-weeks||||kg/m^2||95% Confidence Interval|Mean
2540469|NCT03047447|Secondary|Weight|Weight was measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet group with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for weight at week 10 minus weight at week 0.|10-weeks||||pounds||95% Confidence Interval|Mean
2540470|NCT03047447|Primary|Hemoglobin A1c|Hemoglobin A1c (HgA1c) was measured at week 0 and week 3, 6 and 10 for the experimental ketogenic group, the control standard American diet group with no exercise, and the control standard American diet group with 3-5 days of exercise per week (120-150 minutes/week). The change over time was calculated for HgA1c at week 10 minus the HgA1c value at week 0.|Week 0 - Week 10||||% of hemoglobin||95% Confidence Interval|Mean
2540471|NCT03047174|Secondary|Change in Quality of Life Between Screening and 50 Gy of Radiotherapy|"Quality of Life was assessed using the EORTC QLQ-C30 and QLQ-H&N35 questionnaires.~For QLQ-C30, scoring of global health status and functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning) were assessed. Scores ranged from 0 to 100. A higher score represented a higher level of quality of life (global health status) and a higher level of functioning (functional scales).~For QLQ-H&N35, symptom scales (pain, problems with swallowing, senses problems, speech problems, trouble with social eating, trouble with social contact) were assessed Scores ranged from 0 to 100. A higher score represented a higher level of symptomatology/problems.~For both questionnaires (QLQ-C30 and QLQ-H&N35), the change between baseline and follow up at 50 Gy for each item was calculated by using the mean value of the differences between both time points of the evaluable patients."|at 50 Gy (about 5 weeks)|For evaluations with the QLQ-C30 questionnaire, data of 19 patients (3 in Arm A, 16 in Arm B) were available, and for evaluations with the QLQ-H&N35 questionnaire, data of 18 patients (3 in Arm A, 15 in Arm B).|||score on a scale||Standard Deviation|Mean
2540472|NCT03047174|Secondary|Median Pain Score at the Irradiated Skin at 60 Gy|The pain score will be assessed by using a numeric self rating scale from 0 (no pain) to 10 (maximum pain) points.|at 60 Gy (about 6 weeks)|Patients of the Intention-to-treat Population who were evaluable for pain at 60 Gy.|||score on a scale||Full Range|Median
2540473|NCT03047174|Secondary|Median Pain Score at the Irradiated Skin at 50 Gy|The pain score will be assessed by using a numeric self rating scale from 0 (no pain) to 10 (maximum pain) points.|at 50 Gy (about 5 weeks)|Patients of the Intention-to-treat Population who were evaluable for pain at 50 Gy.|||score on a scale||Full Range|Median
2540474|NCT03047174|Secondary|Median Number of Radiation Fractions Until Occurence of Grade 2 Dermatitis|The number of fractions of radiotherapy up to 50 Gy (50 Gy = 25 fractions) was counted in the intent-to-treat population, until grade 2 radiation dermatitis occurred.|up to 50 Gy (about 5 weeks)|Patients of the Intention-to-treat Population who were evaluable for median number of radiation fractions (up to 50 Gy) until occurence of grade 2 dermatitis|||number of fractions of radiotherapy||Full Range|Median
2540475|NCT03047174|Secondary|Number of Participants With Grade ≥3 Radiation Dermatitis at 60 Gy (Intention-to-treat Population)|Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.|at 60 Gy (about 6 weeks)|Patients of the Intention-to-treat Population who were evaluable for radiation dermatitis at 60 Gy.|||Participants|||Count of Participants
2540476|NCT03047174|Secondary|Number of Participants With Grade ≥3 Radiation Dermatitis at 50 Gy (Intention-to-treat Population)|Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.|at 50 Gy (about 5 weeks)|Intention-To-Treat Population|||Participants|||Count of Participants
2540477|NCT03047174|Secondary|Number of Participants With Grade ≥2 Radiation Dermatitis at 60 Gy (Intention-to-treat Population)|Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.|at 60 Gy (about 6 weeks)|Patients of the Intention-To-Treat Population who were evaluable for radiation dermatitis at 60 Gy.|||Participants|||Count of Participants
2540478|NCT03047174|Secondary|Number of Participants With Grade ≥2 Radiation Dermatitis at 50 Gy (Intention-to-treat Population)|Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.|at 50 Gy (about 5 weeks)|Intention-to-Treat Population|||Participants|||Count of Participants
2540479|NCT03047174|Secondary|Number of Participants With Grade ≥3 Radiation Dermatitis at 60 Gy (Per Protocol Set)|Radiation dermatitis has been assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.|at 60 Gy (about 6 weeks)|Patients of the Per Protocol Set who were evaluable for radiation dermatitis at 60 Gy.|||Participants|||Count of Participants
2540483|NCT03046472|Primary|Back Postural Behavior|"the investigator observes the participant in 8 different positions: sitting in the waiting room, walking to the treatment room, sitting in front of the therapist, placing a mattress on the floor, exercising in six position, exercising in sitting position, exercising in standing position, and changing between positions. Each position get a subscore as 0-bad posture 1-fair 2-good. Overall postural behavior: was comprised of all 8 observations including: grades 0 to 16. An higher score is a better behavior.~spontaneous behavior was comprised of 4 sob score that ha a spontaneous characteristics: sitting waiting for treatment, walking into the room, sitting during treatment and transition between exercises. summation of these 4 would range 0-8 . an Higher score is a better behavior."|2 time points. before starting intervention and after 3 months.||||score on a scale||Standard Deviation|Mean
2540484|NCT03046472|Primary|Low Back Pain|VAS Scale 0-10 0 no pain 1-2 very mild pain 2-3 mild pain 4-6 moderate pain 7-8 high pain 9-10 very high pain|2 time points. before starting intervention and after 3 months.|only 33 out of 50 had LBP 21 in once a month group and 12 in once a month and once a week|||score on a scale||Standard Deviation|Mean
2540485|NCT03046472|Primary|Thoracic Kyphosis Angle|"Normal thoracic kyphosis angle ranges between 25°-40°. Measuring by Digital Inclinometer by placing it on the spinous process of T1 and T12 and the outcome off subtraction the two numbers is our out come.~The participant is to stand how ever he think is the best posture."|2 time points. before starting intervention and after 3 months.||||degrees||Standard Deviation|Mean
2540486|NCT03046446|Other Pre-specified|Knee Injury and Osteoarthritis Outcome Score (KOOS) QOL Subscale|"KOOS is a participant (patient)-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury and also consequences of primary osteoarthritis (OA). It holds 42 items in five separately scored sub-scales: KOOS Pain, KOOS Symptoms, Function in daily living, Function in Sport and Recreation, and knee-related Quality of Life (KOOS QOL). Only KOOS QOL sub-scale (Q1-Q4) was used in this study.~A Likert scale is used and all items have five possible answer options scored from 0 (No Problem) to 4 (Extreme Problems). Each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. Higher scores indicate a better quality of life.~KOOS was administered at study visits from BL/Day 1 through week 52."|Up to 12 Weeks Post Each FX006 Administration|Participants who received a repeat administration of FX006|||score on a scale||Standard Deviation|Mean
2540487|NCT03046446|Other Pre-specified|WOMAC C Function Subscale|"The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. WOMAC C is the independent sub-scale for function that is comprised of 17 questions.~WOMAC C was administered at each visit from screening through Week 52/EOS."|12 Weeks Post Each FX006 Administration|Participants who received a repeat administration of FX006 at weeks 12, 16, 20 or 24.|||score on a scale||Standard Deviation|Mean
2540488|NCT03046446|Other Pre-specified|WOMAC B Stiffness Subscale|"The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. WOMAC B is the independent sub-scale for stiffness that is comprised of 2 questions.~WOMAC B was administered at each visit from screening through Week 52/EOS."|12 Weeks Post Each FX006 Administration|Participants who received a repeat administration of FX006 at weeks 12, 16, 20 or 24.|||score on a scale||Standard Deviation|Mean
2540489|NCT03046446|Other Pre-specified|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A Pain Subscale|"The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. WOMAC A is the independent sub-scale for pain that is comprised of 5 questions.~WOMAC A was administered at each visit from screening through Week 52/EOS."|12 Weeks Post Each FX006 Administration|Participants who received a repeat administration of FX006 at weeks 12, 16, 20 or 24.|||score on a scale||Standard Deviation|Mean
2540490|NCT03046446|Primary|Total Number of Treatment Emergent Adverse Events (TEAEs) in Patients With Symptomatic Osteoarthritis (OA) of the Knee Who Received Two Doses of 32 mg FX006|Analyses of adverse events (AE) were performed for events considered treatment-emergent (TE) in patients who received two doses of 32 mg FX006. TE was defined as any AE with onset after administration of the 1st dose of study drug or any event present at baseline but worsened in intensity through the study. Severity was graded by the PI using the Common Terminology Criteria for AEs Version 4.0. Grading went from Grade 1 (Mild) to Grade 5 (Death Related to AE).|Up to 52 Weeks|Received 2 doses of FX006|||TEAEs|||Number
2540491|NCT03046225|Secondary|Change in Knee Range of Motion From Baseline to 30 Minutes|It was extracted from the continuous passive movement device display. During the use of the continuous passive movement device (CPM), from the observation of the digital display in its control, the degrees of amplitude reached in the passive movements of flexion and extension of the knee submitted to the surgery were extracted.|30 minutes||||Degrees||Standard Deviation|Mean
2540492|NCT03046225|Secondary|Number of Participants Who Received Morphine Within 24 Hours|It was evaluated based on the information found in patients' electronic records, considering whether they received morphine during the 24 hours following the interventions or not.|24 hours||||Participants|||Number
2540493|NCT03046225|Primary|Change in Pain Level From Baseline to 90 Minutes|"It was measured by Visual Analogue Pain Scale (VAS), which has scores ranging from zero (which means no pain) to 10 (which means worst possible pain). Two evaluations of the pain level were performed in each group, before and after the interventions."|90 minutes||||Units on a scale||Standard Deviation|Mean
2540494|NCT03046212|Secondary|Number of Participants Who Received Morphine Within 24 Hours|It was evaluated based on the information found in patients' electronic records, considering whether they received morphine during the 24 hours following the interventions or not.|24 hours||||participants|||Number
2540496|NCT03046212|Primary|Change in Pain Level From Baseline to 45 Minutes|"It was measured by Visual Analogue Pain Scale (VAS), which has scores ranging from zero (which means no pain) to 10 (which means worst possible pain). Two evaluations were performed in each group, before and after the interventions."|baseline, 45 minutes||||units on a scale||Standard Deviation|Mean
2540497|NCT03045926|Secondary|Mean Change From Baseline in Urine Nickel Levels During the Treatment Period and Post-treatment Follow-up Period|"Baseline urine nickel levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.~The absolute mean change from baseline in urine nickel levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up."|Screening and pre-dose Day -1 up to Day 95.|The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL.|||ng/mL||95% Confidence Interval|Mean
2540498|NCT03045926|Secondary|Mean Change From Baseline in Urine Mercury Levels During the Treatment Period and Post-treatment Follow-up Period|"Baseline urine mercury levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.~The absolute mean change from baseline in urine mercury levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up."|Screening and pre-dose Day -1 up to Day 95.|The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL.|||ng/mL||95% Confidence Interval|Mean
2540499|NCT03045926|Secondary|Mean Change From Baseline in Urine Cobalt Levels During the Treatment Period and Post-treatment Follow-up Period|"Baseline urine cobalt levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.~The absolute mean change from baseline in urine cobalt levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up."|Screening and pre-dose Day -1 up to Day 95.|The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL.|||ng/mL||95% Confidence Interval|Mean
2540500|NCT03045926|Secondary|Mean Change From Baseline in Urine Cadmium Levels During the Treatment Period and Post-treatment Follow-up Period|"Baseline urine cadmium levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.~The absolute mean change from baseline in urine cadmium levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up."|Screening and pre-dose Day -1 up to Day 95.|The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL.|||ng/mL||95% Confidence Interval|Mean
2540501|NCT03045926|Secondary|Mean Change From Baseline in Urine Barium Levels During the Treatment Period and Post-treatment Follow-up Period|"Baseline urine barium levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.~The absolute mean change from baseline in urine barium levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up."|Screening and pre-dose Day -1 up to Day 95.|The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL.|||ng/mL||95% Confidence Interval|Mean
2540502|NCT03045926|Secondary|Mean Change From Baseline in Urine Arsenic Levels During the Treatment Period and Post-treatment Follow-up Period|"Baseline urine arsenic levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.~The absolute mean change from baseline in urine arsenic levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up."|Screening and pre-dose Day -1 up to Day 95.|The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL.|||ng/mL||95% Confidence Interval|Mean
2540503|NCT03045926|Secondary|Mean Change From Baseline in Urine Aluminium Levels During the Treatment Period and Post-treatment Follow-up Period|"Baseline urine aluminium levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.~The absolute mean change from baseline in urine aluminium levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up."|Screening and pre-dose Day -1 up to Day 95.|The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL.|||ng/mL||95% Confidence Interval|Mean
2540504|NCT03045926|Secondary|Mean Change From Baseline in Urine Lead Levels During the Treatment Period and Post-treatment Follow-up Period|"Baseline urine lead levels were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.~The absolute mean change from baseline in urine lead levels are presented for Day 35 of the treatment period (Visit 7, Week 5), and Day 65 (Visit 8, Week 9) and Day 95 (Visit 9, Week 13) in the post-treatment follow-up."|Screening and pre-dose Day -1 up to Day 95.|The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL.|||ng/mL||95% Confidence Interval|Mean
2540522|NCT03045887|Secondary|Part A: Maximum Observed Plasma Drug Concentration (Cmax) of GSK2292767|Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Five min post dose concentrations on Days 2-13 were assumed to be the Cmax values. Data for Cmax of GSK2292767 for part A is presented. Cmax is defined as maximum observed plasma concentration of GSK2292767.|Pre-dose (5 min, 30 min, 45 min, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, and 24 hr post dose in each of the 3 treatment periods|Pharmacokinetic Population|||Picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2552754|NCT02790281|Primary|Exploratory: Levels of C-reactive Protein (CRP)|Blood sample was taken for analysis of levels of CRP.|At Day 1|All eligible subjects with CRP >5 mg/L|||mg/L||Full Range|Median
2540505|NCT03045926|Secondary|Mean Change From Baseline in Blood Nickel Concentrations During the Treatment Period and Post-treatment Follow-up Period|"Baseline blood nickel concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.~The absolute mean change from baseline in blood nickel concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning.~The absolute mean change from baseline in blood nickel concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study)."|Screening and pre-dose Day -1 up to Day 125.|The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL. Subjects with data available at the timepoints analysed are presented.|||ng/mL||95% Confidence Interval|Mean
2540506|NCT03045926|Secondary|Mean Change From Baseline in Blood Mercury Concentrations During the Treatment Period and Post-treatment Follow-up Period|"Baseline blood mercury concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.~The absolute mean change from baseline in blood mercury concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning.~The absolute mean change from baseline in blood mercury concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study)."|Screening and pre-dose Day -1 up to Day 125.|The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL. Subjects with data available at the timepoints analysed are presented.|||ng/mL||95% Confidence Interval|Mean
2540507|NCT03045926|Secondary|Mean Change From Baseline in Blood Cobalt Concentrations During the Treatment Period and Post-treatment Follow-up Period|"Baseline blood cobalt concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.~The absolute mean change from baseline in blood cobalt concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning.~The absolute mean change from baseline in blood cobalt concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study)."|Screening and pre-dose Day -1 up to Day 125.|The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL. Subjects with data available at the timepoints analysed are presented.|||ng/mL||95% Confidence Interval|Mean
2540508|NCT03045926|Secondary|Mean Change From Baseline in Blood Cadmium Concentrations During the Treatment Period and Post-treatment Follow-up Period|"Baseline blood cadmium concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.~The absolute mean change from baseline in blood cadmium concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning.~The absolute mean change from baseline in blood cadmium concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study)."|Screening and pre-dose Day -1 up to Day 125.|The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL. Subjects with data available at the timepoints analysed are presented.|||ng/mL||95% Confidence Interval|Mean
2540509|NCT03045926|Secondary|Mean Change From Baseline in Blood Barium Concentrations During the Treatment Period and Post-treatment Follow-up Period|"Baseline blood barium concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.~The absolute mean change from baseline in blood barium concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning.~The absolute mean change from baseline in blood barium concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study)."|Screening and pre-dose Day -1 up to Day 125.|The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL. Subjects with data available at the timepoints analysed are presented.|||ng/mL||95% Confidence Interval|Mean
2540510|NCT03045926|Secondary|Mean Change From Baseline in Blood Arsenic Concentrations During the Treatment Period and Post-treatment Follow-up Period|"Baseline blood arsenic concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.~The absolute mean change from baseline in blood arsenic concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning.~The absolute mean change from baseline in blood arsenic concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study)."|Screening and pre-dose Day -1 up to Day 125.|The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL. Subjects with data available at the timepoints analysed are presented.|||ng/mL||95% Confidence Interval|Mean
2540523|NCT03045887|Secondary|Part B: AUC (0 to t), AUC (0 to 24) and AUC (0 to Inf) of GSK2292767|Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Data for AUC (0 to t), AUC (0 to 24) and AUC (0 to inf) of GSK2292767 for part B is presented. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 1; pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 14|Pharmacokinetic population|||Hours*picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2540511|NCT03045926|Secondary|Mean Change From Baseline in Blood Aluminium Concentrations During the Treatment Period and Post-treatment Follow-up Period|"Baseline blood aluminium concentrations were defined as the average between the available screening and pre-dose (Day-1) values. Values below the LOD or below the LLOQ were replaced by LOD/2 or LLOQ/2 values.~The absolute mean change from baseline in blood aluminium concentrations during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning.~The absolute mean change from baseline in blood aluminium concentrations during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study)."|Screening and pre-dose Day -1 up to Day 125.|The ITT population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL. Subjects with data available at the timepoints analysed are presented.|||ng/mL||95% Confidence Interval|Mean
2540512|NCT03045926|Primary|Mean Change From Baseline in Blood Lead Levels During the Treatment Period and Post-treatment Follow-up Period|"Baseline blood lead levels (BLL) were defined as the average between the available screening and pre-dose (Day-1) values. Values below the limit of detection (LOD) or below the lower limit of quantification (LLOQ) were replaced by LOD/2 or LLOQ/2 values.~The absolute mean change from baseline in BLL during the treatment period is presented for the timepoints: 2 hours after the first dose, and prior to and after the second and third doses on Days 1 and 35, prior to the first dose on Days 2, 8, 15, 22 and 29, and on Day 36 in the morning.~The absolute mean change from baseline in BLL during the post-treatment follow-up period is presented for the timepoints: Day 65, Day 95, and Day 125 (End of Study)."|Screening and pre-dose Day -1 up to Day 125.|The Intention-to-Treat (ITT) population consisted of all subjects who received at least one dose of study medication and who had one pre-dose BLL and at least one post-dose BLL. Subjects with data available at the timepoints analysed are presented.|||nanograms per millilitre (ng/mL)||95% Confidence Interval|Mean
2540513|NCT03045887|Secondary|Part B: Concentration of GSK2292767 in Lung Epithelial Lining Fluid (ELF)|ELF from the lung was extracted from BAL samples. ELF drug concentration was calculated as BAL fluid drug concentration multiplied by dilution factor where dilution factor = Plasma urea (pre-bronchoscopy) divided by BAL urea. NA indicates data not available. Only participants with data available at specified time points were analyzed (represented by n=X in category titles).|Day 15|Pharmacokinetic Population|||Picograms per milliliters||Geometric Coefficient of Variation|Geometric Mean
2540514|NCT03045887|Secondary|Part B: Concentration of GSK2292767 in Bronchoalveolar Lavage (BAL)|BAL samples were collected by bronchoscopy.|Day 15|Pharmacokinetic Population|||Picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2540515|NCT03045887|Secondary|Part B: Ctau of GSK2292767|Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Data for Ctau of GSK2292767 for part B is presented. Ctau is defined as the lowest concentration reached by a drug before the next dose is administered. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 1; pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 14|Pharmacokinetic Population|||Pico grams per milliliter||Geometric Coefficient of Variation|Geometric Mean
2540516|NCT03045887|Secondary|Part A: Trough Concentrations (Ctau) of GSK2292767|Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Data for Ctau of GSK2292767 for part A is presented. Ctau is defined as the lowest concentration reached by a drug before the next dose is administered.|24 hr post dose in each of the 3 treatment periods|Pharmacokinetic population|||Picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2540517|NCT03045887|Secondary|Part B: T1/2 of GSK2292767|Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Data for T1/2 of GSK2292767 for part B is presented. T1/2 was defined as the time required for one half of the total amount of a particular substance in a biological system to be degraded by biological processes. Only those participants with data available at the specified time points were analyzed.|Pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 1; pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 14|Pharmacokinetic Population|||Hours||Geometric Coefficient of Variation|Geometric Mean
2540518|NCT03045887|Secondary|Part A: Terminal Half-life (T1/2) of GSK2292767|Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Data for T1/2 of GSK2292767 for part A is presented. T1/2 is defined as the time required for one half of the total amount of a particular substance in a biological system to be degraded by biological processes. Only those participants with data available at the specified time points were analyzed.|Pre-dose (5 min, 30 min, 45 min, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, and 24 hr post dose in each of the 3 treatment periods|Pharmacokinetic Population|||Hours||Geometric Coefficient of Variation|Geometric Mean
2540519|NCT03045887|Secondary|Part B: Tmax of GSK2292767|Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Data for Tmax of GSK2292767 for part B is presented.|Pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 1; pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 14|Pharmacokinetic Population|||Hours||Full Range|Median
2540520|NCT03045887|Secondary|Part A: Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK2292767|Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Data for Tmax of GSK2292767 for part A is presented.|Pre-dose (5 min, 30 min, 45 min, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, and 24 hr post dose in each of the 3 treatment periods|Pharmacokinetic Population|||Hours||Full Range|Median
2540521|NCT03045887|Secondary|Part B: Cmax of GSK2292767|Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Five minute post dose concentrations on Days 2-13 were assumed to be the Cmax values. Data for Cmax of GSK2292767 for part B is presented.|Pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 1; pre-dose, 5 minutes, 30 minutes, 45 minutes, 1, 2, 3, 4, 6, 8 and 12hours post dose on Day 14|Pharmacokinetic Population|||Picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2540901|NCT03039088|Secondary|The Relative Attributable Risks of the Doctor's Reported Outcomes Versus the Patients Reported Outcomes in the Decision to Initiate/Switch Anti-TNF Therapy||At 12 weeks after TNF alpha blockers initiation|||||||
2540524|NCT03045887|Secondary|Part A: Area Under the Plasma Drug Concentration Versus Time Curve (AUC) From Zero to Time t (AUC [0 to t]), AUC From Zero to 24 Hours (AUC [0 to 24]) and AUC From Zero to Infinity (AUC [0 to Inf]) of GSK2292767|Blood samples were collected for pharmacokinetic analysis of GSK2292767 at the specified time points. Data for AUC (0 to t), AUC (0 to 24) and AUC (0 to inf) of GSK2292767 for part A is presented. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Pharmacokinetic population comprised of participants in the 'All participant' population for whom a pharmacokinetic sample was obtained and analyzed.|Pre-dose (5 minutes (min), 30 min, 45 min, 1 hour (hr), 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 12 hr, and 24 hr post dose in each of the 3 treatment periods|Pharmacokinetic Population|||Hours*picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2540525|NCT03045887|Primary|Part B: Number of Participants With Hematology Values of PCC|Number of participants with hematology parameters of PCC which shifted from normal to high in part B are presented. Hematology parameters for which PCC values were identified were: Hemoglobin, Hematocrit, Lymphocytes, Total Neutrophils, Platelet count and WBC count|Pre-dose on Days 2, 4, 6, 8, 10, 12, and 14, 24 hours post-dose on Day 14|Safety Population|||Participants|||Count of Participants
2540526|NCT03045887|Primary|Part A: Number of Participants With Hematology Values of PCC|Number of participants with hematology parameters of PCC which shifted from normal to high in part A are presented. Hematology parameters for which PCC values were identified were: Hemoglobin, Hematocrit, Lymphocytes, Total Neutrophils, Platelet count and White Blood Cell (WBC) Count. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)|24 hours post-dose in each treatment period|Safety Population|||Participants|||Count of Participants
2540527|NCT03045887|Primary|Part B: Number of Participants With Clinical Chemistry Values of PCC|Number of participants with clinical chemistry values that changed from normal to high or low in part B are presented. Chemistry parameters for which PCC values were identified were: Alkaline Phosphatase, Alanine Amino Transferase, aspartate aminotransferase, Total Bilirubin, calcium, glucose, potassium and Sodium. Only participants with data available at specified time points were analyzed (represented by n=X in category titles)|Pre-dose on Days 2, 4, 6, 8, 10, 12, and 14, 24 hours post-dose on Day 14|Safety Population|||Participants|||Count of Participants
2540528|NCT03045887|Primary|Part A: Number of Participants With Clinical Chemistry Values of Potential Clinical Importance Criteria (PCC)|Number of participants with clinical chemistry values that changed from normal to high or low in part A are presented. Chemistry parameters for which PCC values were identified were: Alkaline Phosphatase, Alanine Amino Transferase, aspartate aminotransferase, Total Bilirubin, calcium, glucose, potassium and Sodium.|24 hours post-dose in each treatment period.|Safety Population|||Participants|||Count of Participants
2540529|NCT03045887|Primary|Part B: Number of Participants With ECG Abnormalities|Triplicate/Single 12-lead ECG was obtained using an automated ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTFc intervals. Number of participants with abnormal clinically significant and abnormal-not clinically significant values at any time post-Baseline is presented.|Pre-dose on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14, 24 hours post-dose on Day 14|Safety Population|||Participants|||Count of Participants
2540530|NCT03045887|Primary|Part A: Number of Participants With Electrocardiogram (ECG) Abnormalities|Triplicate/Single 12-lead ECG was obtained using an automated ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTFc intervals. Number of participants with abnormal clinically significant and abnormal-not clinically significant values at any time post-Baseline is presented.|Day 1 of each treatment period|Safety Population|||Participants|||Count of Participants
2540531|NCT03045887|Primary|Part B: Forced Vital Capacity (FVC)|FVC is a measure of lung function and is defined as total amount of air that can be exhaled during FEV1 test. FVC was planned to measured using spirometry. The FVC need to be normal at screening and is part of the Forced Expiratory ratio (FEV1/FVC) which should lie between 0.7-0.8 to indicate no chronic obstruction or restriction. The FVC was therefore only used at screening and requires no ongoing analysis during the study. All other indications of obstruction in the study, e.g. paradoxical bronchospasm was provided by the FEV1. The FVC therefore require no analysis.|Day 1 (pre-dose and 1 hour)|Safety Population. Data was not collected for this outcome as FVC was used only at screening and no further analysis during the study was required.||||||
2540532|NCT03045887|Primary|Part A: Forced Vital Capacity (FVC)|FVC is a measure of lung function and is defined as total amount of air that can be exhaled during FEV1 test. FVC was planned to measured using spirometry. The FVC need to be normal at screening and is part of the Forced Expiratory ratio (FEV1/FVC) which should lie between 0.7-0.8 to indicate no chronic obstruction or restriction. The FVC was therefore only used at screening and requires no ongoing analysis during the study. All other indications of obstruction in the study, e.g. paradoxical bronchospasm was provided by the FEV1. The FVC therefore require no analysis.|Day 1 (pre-dose and 1 hour)|Safety Population. Data was not collected for this outcome as FVC was used only at screening and no further analysis during the study was required.||||||
2540533|NCT03045887|Primary|Part B: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry at the indicated time. Existing spirometry equipment was used. FEV1 measurements were repeated until three technically acceptable measurements (within 150 mL of each other) were made. Data for FEV1 for part B is presented here.|Up to Day 14|Safety Population|||Liters||Standard Deviation|Mean
2540534|NCT03045887|Primary|Part A: Maximal Amount of Air Forcefully Exhaled in 1 Second (FEV1)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry at the indicated time. FEV1 measurements were repeated until three technically acceptable measurements (within 150 milliliter [mL] of each other) were made. Data for FEV1 for part A is presented here.|Day 1 (pre-dose and 1 hour)|Safety Population|||Liters||Standard Deviation|Mean
2540557|NCT03045861|Primary|Tmax for GSK2838232 Following Administration on Day 10|Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.|Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 10|Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.|||Hours||Full Range|Median
2552755|NCT02790281|Primary|Exploratory: Levels of IL-6|Blood sample was taken for analysis of levels of IL-6.|At Day 1|All eligible subjects with CRP >5 mg/L|||pg/mL||Full Range|Median
2540535|NCT03045887|Primary|Part B: Change From Baseline in Tympanic Temperature|Tympanic temperature in part B was assessed in semi supine position after 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as measurements done on Day -1. Change from Baseline was defined as the value at indicated time point minus Baseline value. Baseline was defined as latest pre-dose measurement. Change from Baseline was defined as the value at indicated time point minus Baseline value.|Baseline, Pre-dose on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14, 24 hours post-dose on Day 14|Safety Population|||Celsius||Standard Deviation|Mean
2540536|NCT03045887|Primary|Part A: Change From Baseline in Tympanic Temperature|Tympanic temperature in part A was assessed in semi supine position after 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as measurements done on Day -1. Change from Baseline was defined as the value at indicated time point minus Baseline value. Baseline was defined as latest pre-dose measurement. Change from Baseline was defined as the value at indicated time point minus Baseline value.|Baseline, 30 minutes, 1, 6, 12 and 24 hours post-dose in each treatment period|Safety Population|||Celsius||Standard Deviation|Mean
2540537|NCT03045887|Primary|Part B: Change From Baseline in Respiratory Rate|Respiratory rate in part B was assessed in a semi supine position after 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as measurements done on Day -1. Change from Baseline was defined as the value at indicated time point minus Baseline value. Baseline was defined as latest pre-dose measurement. Change from Baseline was defined as the value at indicated time point minus Baseline value.|Baseline, Pre-dose on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14, 24 hours post-dose on Day 14|Safety Population|||Breaths per minute||Standard Deviation|Mean
2540538|NCT03045887|Primary|Part A: Change From Baseline in Respiratory Rate|Respiratory rate in part A was assessed in a semi supine position after 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as measurements done on Day -1. Change from Baseline was defined as the value at indicated time point minus Baseline value. Baseline was defined as latest pre-dose measurement. Change from Baseline was defined as the value at indicated time point minus Baseline value.|Baseline, 30 minutes, 1, 6, 12 and 24 hours post-dose in each treatment period|Safety Population|||Breaths per minute||Standard Deviation|Median
2540539|NCT03045887|Primary|Part B: Change From Baseline in Heart Rate|Heart rate in part B was assessed in a semi supine position with a completely automated device. Heart rate measurement was preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as latest pre-dose measurement. Change from Baseline was defined as the value at indicated time point minus Baseline value.|Baseline, Pre-dose on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14, 24 hours post-dose on Day 14|Safety Population|||Beats per minute||Standard Deviation|Mean
2540540|NCT03045887|Primary|Part A: Change From Baseline in Heart Rate|Heart rate in part A was assessed in a semi supine position with a completely automated device. Heart rate measurement was preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as latest pre-dose measurement. Change from Baseline was defined as the value at indicated time point minus Baseline value.|Baseline, 30 minutes, 1, 6, 12 and 24 hours post-dose in each treatment period|Safety Population|||Beats per minute||Standard Deviation|Mean
2540541|NCT03045887|Primary|Part B: Change From Baseline in SBP and DBP|Blood pressure in part B were assessed in semi supine position with a completely automated device. SBP and DBP preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as measurements done on Day -1. Change from Baseline was defined as the value at indicated time point minus Baseline value.|Baseline, Pre-dose on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14, 24 hours post-dose on Day 14|Safety Population|||Millimeters of mercury||Standard Deviation|Mean
2540542|NCT03045887|Primary|Part A: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure in part A was assessed in a semi supine position with a completely automated device. SBP and DBP measurements were preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment. Change from Baseline was defined as the value at indicated time point minus Baseline value.|Baseline, 30 minutes, 1, 6, 12 and 24 hours post-dose in each treatment period|Safety Population|||Millimeters of mercury||Standard Deviation|Mean
2540543|NCT03045887|Primary|Part B: Number of Participants With Any AE and Any SAE|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Participants with 5 percent nSAEs and SAEs has been reported.|Up to 4 weeks|Safety Population|||Participants|||Count of Participants
2540544|NCT03045887|Primary|Part A: Number of Participants With Any Non-serious Adverse Event (nSAE) and Any Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Participants with 5 percent nSAEs and SAEs has been reported.|Up to 12 weeks|Safety Population comprised of all randomized participants who took at least 1 dose of study treatment.|||Participants|||Count of Participants
2540545|NCT03045861|Secondary|Steady State Assessment of Plasma Pre-dose Concentrations by Treatment|A linear mixed model using Day, treatment and Day by treatment as fixed effects and participant as a random effect on the log-transformed pre-dose values was performed to evaluate if steady state was achieved using the Helmert transformation approach. The comparison was done as Day 8 versus the average of Days 9 and 10 values. The ratio of geometric least square mean for Day 8 versus average of Days 9 and 10 values is presented along with 95% confidence interval.|Pre-dose on Days 8, 9 and 10|Pharmacokinetic Population|||Ratio||95% Confidence Interval|Number
2540546|NCT03045861|Secondary|Pre-morning Dose Concentrations (C0) on Day 2 Through 11|Blood samples were collected for pharmacokinetic analysis of GSK2838232. The pre-morning dose concentrations for Days 2 to 11 is presented. One participant from GSK2838232 100 mg arm was dosed with GSK2838232 50 mg on Days 1 and 2; hence, pharmacokinetic parameters for that participant were summarized with GSK2838232 50 mg for Days 1 and 2 and with GSK2838232 100 mg for Days 3 to 10.|Pre-dose on Days 2, 3, 4, 5, 8, 9, 10 and 11|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Nanograms per milliliter||Standard Deviation|Mean
2540547|NCT03045861|Secondary|Dose Proportionality of GSK2838232|Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232. Dose proportionality was assessed using a fixed effects power model. Estimated slope and 90% confidence interval is presented.|pre dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Days 1 and 10|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category )|||slope of log dose||90% Confidence Interval|Number
2540548|NCT03045861|Secondary|Accumulation Ratio for GSK2838232|Serial blood samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232. The accumulation ratios were calculated as R_AUC=AUC(0-tau) Day 10/AUC(0-24) Day 1; R_Cmax=Cmax Day 10/Cmax Day 1 and R_Ctau=Ctau Day 10/C24 Day 1.|pre dose, and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Days 1 and 10; pre-dose on Days 3, 4, 5, 8 and 9; Days 12 and 14|Pharmacokinetic Population. Only participants with data available at the specified time points were analyzed.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2540549|NCT03045861|Secondary|Number of Participants With Emergent Drug Resistance Mutations|Plasma samples were collected to evaluate treatment-emergent genotypic mutations in Gag, reverse transcriptase (RT) and protease (PR) and to assess phenotypic resistance to GSK2838232 and RT and PR drugs. Number of participants with treatment emergent RT/PR mutations, reduced susceptibility to nucleoside/nucleotide reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or protease inhibitor (PI), treatment emergent maturation inhibitor A364A/V and GSK2838232 phenotypic resistance is presented.|Up to Day 11|ITT Population|||Participants|||Count of Participants
2540550|NCT03045861|Secondary|Change From Baseline to Day 11 in CD4+ Count Relative to Day 10 Ctau|The relationship between pharmacokinetic parameters (Ctau) and pharmacodynamic measures (change from Baseline CD4+ cell count) was explored using a frequentist linear model. The model parameters estimated included slope and intercept. The estimate (slope) along with 95% confidence interval is presented.|Baseline (Day 1), Days 10 and 11|Pharmacokinetic/Pharmacodynamic Population|||cells/microliter/nanograms/milliliter||95% Confidence Interval|Number
2540551|NCT03045861|Secondary|Change From Baseline to Day 11 in CD4+ Count Relative to Day 10 Cmax|The relationship between pharmacokinetic parameters (Cmax) and pharmacodynamic measures (change from Baseline CD4+ cell count) was explored using a frequentist linear model. The model parameters estimated included slope and intercept. The estimate (slope) along with 95% confidence interval is presented|Baseline (Day 1), Days 10 and 11|Pharmacokinetic/Pharmacodynamic Population|||cells/microliter/nanograms/milliliter||95% Confidence Interval|Number
2540552|NCT03045861|Secondary|Change From Baseline to Day 11 in CD4+ Count Relative to Day 10 AUC (0 to Tau)|The relationship between pharmacokinetic parameters (AUC) and pharmacodynamic measures (change from Baseline CD4+ cell count) was explored using a frequentist linear model. The model parameters estimated included slope and intercept. The estimate (slope) along with 95% confidence interval is presented.|Baseline (Day 1), Days 10 and 11|Pharmacokinetic/Pharmacodynamic Population|||cells/microliter/ng*h/mL||95% Confidence Interval|Number
2540553|NCT03045861|Secondary|Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count to Day 11|CD4+ cell counts were assessed by flow cytometry. Baseline value is the latest pre-dose assessment value. Change from Baseline is calculated as the post-dose visit value minus Baseline value.|Baseline (Day 1) and Day 11|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Cells per microliter||Standard Deviation|Mean
2540554|NCT03045861|Secondary|Change From Baseline to Day 11 in log10 Plasma HIV-1 RNA Relative to Day 10 Ctau|Plasma samples were collected for quantitative analysis of HIV-1 RNA. Change from Baseline is the value at indicated time point minus Baseline value. Statistical analysis for the relationship between pharmacokinetic parameters (Ctau) and pharmacodynamic measures (change from Baseline in log10 plasma HIV-1 RNA) was explored using a frequentist three parameter Emax non-linear model. The model parameters estimated included: maximum response (Emax), pharmacokinetic parameter value that attains the 50% of the maximal effect (ED50) and s2e.|Baseline (Day 1), Days 10 and 11|Pharmacokinetic/Pharmacodynamic Population.|||log10 copies per milliliter||Standard Deviation|Mean
2540555|NCT03045861|Secondary|Change From Baseline to Day 11 in log10 Plasma HIV-1 RNA Relative to Day 10 Cmax|Plasma samples were collected for quantitative analysis of HIV-1 RNA. Change from Baseline is the value at indicated time point minus Baseline value. Statistical analysis for the relationship between pharmacokinetic parameters (Cmax) and pharmacodynamic measures (change from Baseline in log10 plasma HIV-1 RNA) was explored using a frequentist three parameter Emax non-linear model. The model parameters estimated included: maximum response (Emax), pharmacokinetic parameter value that attains the 50% of the maximal effect (ED50) and s2e.|Baseline (Day 1), Days 10 and 11|Pharmacokinetic/Pharmacodynamic Population.|||log10 copies per milliliter||Standard Deviation|Mean
2540556|NCT03045861|Secondary|Change From Baseline to Day 11 in log10 Plasma HIV-1 RNA Relative to Day 10 AUC (0 to Tau)|Plasma samples were collected for quantitative analysis of HIV-1 RNA. Change from Baseline is the value at indicated time point minus Baseline value. Statistical analysis for relationship between pharmacokinetic parameters (AUC) and pharmacodynamic measures (Change from Baseline in plasma HIV-1 RNA) was explored using a frequentist three parameter Emax non-linear model. The model parameters estimated included: maximum response (Emax), pharmacokinetic parameter value that attains 50% of the maximal effect (ED50) and residual variability (s2e). Pharmacokinetic/Pharmacodynamic Population comprised of participants who met criteria for Per-Protocol (all participants who met study criteria and are enrolled into the study with documented evidence of having received all doses and all post-baseline HIV-1 RNA measurement, with exceptions of those who have at least one major protocol deviation) and Pharmacokinetic Population analysis sets and who underwent pharmacodynamic sampling during study.|Baseline (Day 1), Days 10 and 11|Pharmacokinetic/Pharmacodynamic Population|||log10 copies per milliliter||Standard Deviation|Mean
2540558|NCT03045861|Primary|Terminal Elimination Half-life (T1/2) of GSK2838232 Following Administration on Day 10|Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.|Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 10|Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2540559|NCT03045861|Primary|Apparent Oral Clearance of GSK2838232 Following Administration on Day 10|Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.|Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 10|Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2540560|NCT03045861|Primary|Cmax for GSK2838232 on Day 10|Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.|Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 10|Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2540561|NCT03045861|Primary|Concentration at End of Dosing Interval (Ctau) for GSK2838232 on Day 10|Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.|24 hours post-dose on Day 10|Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2540562|NCT03045861|Primary|Pre-dose Concentration (C0) of GSK2838232 on Day 10|Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.|Pre dose on Day 10|Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2540563|NCT03045861|Primary|Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0 to Tau]) for GSK2838232 on Day 10|Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.|Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 10|Pharmacokinetic Population. Only those participants with data available at the specified time point were analyzed.|||Hours*nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2540564|NCT03045861|Primary|Concentration of GSK2838232 at 24 Hours Post-dose on Day 1|Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.|24 hours post-dose on Day 1|Pharmacokinetic Population. One participant from GSK2838232 100 mg arm was dosed with GSK2838232 50 mg on Days 1 and 2; hence, pharmacokinetic parameters for that participant were summarized with GSK2838232 50 mg for Day 1|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2540565|NCT03045861|Primary|Absorption Lag Time (Tlag) for GSK2838232 on Day 1|Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.|Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1|Pharmacokinetic Population. One participant from GSK2838232 100 mg arm was dosed with GSK2838232 50 mg on Days 1 and 2; hence, pharmacokinetic parameters for that participant were summarized with GSK2838232 50 mg for Day 1|||Hours||Full Range|Median
2540566|NCT03045861|Primary|Time to Maximum Observed Concentration (Tmax) for GSK2838232 on Day 1|Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.|Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1|Pharmacokinetic Population. One participant from GSK2838232 100 mg arm was dosed with GSK2838232 50 mg on Days 1 and 2; hence, pharmacokinetic parameters for that participant were summarized with GSK2838232 50 mg for Day 1|||Hours||Full Range|Median
2540567|NCT03045861|Primary|Maximum Observed Concentration (Cmax) for GSK2838232 on Day 1|Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232.|Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1|Pharmacokinetic Population. One participant from GSK2838232 100 mg arm was dosed with GSK2838232 50 mg on Days 1 and 2; hence, pharmacokinetic parameters for that participant were summarized with GSK2838232 50 mg for Day 1|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2540568|NCT03045861|Primary|Area Under the Plasma Concentration Time Curve From Zero (Pre-dose) to 24 Hours (AUC[0 to 24]) for GSK2838232 on Day 1|Serial plasma samples were collected at indicated time points for pharmacokinetic analysis of GSK2838232. The analysis was performed on Pharmacokinetic Population which comprised of participants who received GSK2838232 and underwent plasma pharmacokinetic sampling during the study.|Pre dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1|Pharmacokinetic Population. One participant from GSK2838232 100 mg arm was dosed with GSK2838232 50 mg on Days 1 and 2; hence, pharmacokinetic parameters for that participant were summarized with GSK2838232 50 mg for Day 1|||Hours*nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2540569|NCT03045861|Primary|Number of Participants Who Were Administered Concomitant Medications|Concomitant medications (prescription and non-prescription) were administered only as medically necessary during the study. Number of participants who received any concomitant medications is presented.|Up to Day 22|Safety Population|||Participants|||Count of Participants
2540570|NCT03045861|Primary|Number of Participants With Vital Signs Data Outside Clinical Concern Range|Vital signs were measured in a semi-supine position after 5 minutes rest and included temperature, systolic and diastolic blood pressure and pulse rate. The clinical concern range for vital signs were: systolic blood pressure (SBP) (low: <85 and high: >160 millimeters of mercury [mmHg]) and diastolic blood pressure (DBP) (low: <45 and high: >100 mmHg). Number of participants with vital signs data outside clinical concern range is presented.|Day 1 (pre-dose)|Safety Population|||Participants|||Count of Participants
2540571|NCT03045861|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Triplicate 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Number of participants with abnormal ECG findings at worst-case post Baseline is presented.|Up to Day 22|Safety Population|||Participants|||Count of Participants
2540572|NCT03045861|Primary|Number of Participants With Abnormal Urine Parameters|Urine samples were collected for the assessment of following urine parameters by dipstick method: pH, glucose, protein, blood and ketones. The number of participants with abnormal urine parameters is presented.|Up to Day 22|Safety Population|||Participants|||Count of Participants
2540573|NCT03045861|Primary|Number of Participants With Liver Function Laboratory Abnormalities of Potential Clinical Importance|Blood samples were collected for the assessment of liver function parameters. The clinical concern range for liver function parameters were: albumin (low: <30 g/L), total protein (low: <15 and high: >15 g/L), alanine aminotransferase (high: >=2 times upper limit of normal [ULN]); aspartate aminotransferase (high: >=2 times ULN); alkaline phosphatase (high: >=2 times ULN); total bilirubin (high: >=1.5 times ULN); direct bilirubin (high: >0.3 times ULN).|Up to Day 22|Safety Population|||Participants|||Count of Participants
2540574|NCT03045861|Primary|Number of Participants With Hematology Parameter Abnormalities of Potential Clinical Importance|Blood samples were collected for the assessment of hematology parameters. The clinical concern range for the parameters were: hematocrit (high: >0.54 proportion of red blood cells in blood); hemoglobin (high: >180 grams per liter [g/L]), lymphocytes (low: <0.8x10^9 cells/L); neutrophil count (low: <1.5x10^9 cells/L); platelet count (low: <100x10^9 cells/L and high: >550x10^9 cells/L); white blood cells (low: <3x10^9 cells/L and high: >20x10^9cells/L). Data for any visit post-Baseline is reported.|Up to Day 22|Safety Population|||Participants|||Count of Participants
2540575|NCT03045861|Primary|Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance|Blood samples were collected for the assessment of clinical chemistry parameters. The clinical concern range for the parameters were: carbon dioxide/bicarbonate (low: <18 millimoles per liter [mmol/L] and high: >32 mmol/L); urea (high: >9 mmol/L); creatinine (high: change from Baseline >44.2 micromoles per liter [µmol/L]), glucose (low: <3 and high: >9 mmol/L); potassium (low: <3 and high: >5.5 mmol/L); troponin I (high: >=0.01 micrograms per liter [µg/L]) and sodium (low: <130 mmol/L and high: >150 mmol/L). Data for any visit post-Baseline is reported.|Up to Day 22|Safety Population|||Participants|||Count of Participants
2540576|NCT03045861|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events; is associated with liver injury and impaired liver function. Safety Population comprised of all participants who received at least one dose of study treatment.|Up to Day 22|Safety Population|||Participants|||Count of Participants
2540577|NCT03045861|Primary|Maximum Decline From Baseline in Plasma HIV-1 Ribonucleic Acid (RNA)|Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. An HIV-1 RNA polymerase chain reaction (PCR) assay with a lower limit of detection (LLOD) of 50 copies/milliliter (ultrasensitive assay) was used for post-baseline assessments. Baseline value was the value at latest pre-dose assessment. The maximum decline was determined using change from Baseline in plasma HIV-RNA values at each time point. The analysis was performed on Intent To Treat (ITT) Population which comprised of all participants who met study criteria and were enrolled into the study with documented evidence of having received at least 1 dose of treatment and at least one post-Baseline HIV-1 RNA measurement.|Baseline (Day 1) to Day 21|ITT Population|||Copies per milliliter||Standard Deviation|Mean
2540578|NCT03045809|Primary|Performance of Syndromic Management With or Without Integration of Point-of-care Tests|With performance we mean sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). We determined the number of women who would have received treatment for BV, VVC, TV, NG, and/or CT in the following situations: 1) if we would have followed the WHO syndromic management algorithms for vaginal discharge and lower abdominal pain; and 2) based on the POCT-based WISH algorithms (this is what we did in real life during the study), and compared each of these with gold standard infection-specific diagnoses. The results of the first comparison are reported in the first column and results of the second comparison in the second column.|Each participant was assessed at one main study visit, which lasted up to 4 hours.|Gold standard results availability ranged between 690 to 705 per separate outcome. For CT and NG, results were available for all 705 participants. For BV, VVC, and TV, 690 results were available (15 PCR results were invalid).|||% (sensitivity/specificity/PPV/NPV)||95% Confidence Interval|Number
2540579|NCT03045809|Primary|Feasibility of Integrating Point-of-care Testing (Client Satisfaction Surveys)|Answers to questions about experiences with the procedures (client satisfaction survey).|Each client satisfaction survey was conducted at a main visit and lasted up to 30 min.|A random selection of 107 enrolled women.|||Participants|||Count of Participants
2540580|NCT03045809|Primary|Feasibility of Integrating Point-of-care Testing (Monitoring & Evaluation Indicators)|Clinical monitoring and evaluation indicators: numbers of women with positive CT/NG or syphilis risk scores, number of pelvic exams done, etc (see row titles in the table)|Each participant was assessed at one main study visit, which lasted up to 4 hours.|All 705 women who attended a main visit. Women were aged 18 or older, and at risk of sexually transmitted infections (more than one sex partner and/or having been treated for at least one STI in the past year), with or without urogenital symptoms. HIV-positive and pregnant women were not excluded.|||Participants|||Count of Participants
2540581|NCT03045653|Primary|Progression-free Survival (PFS)||36months||||months||95% Confidence Interval|Median
2540582|NCT03045302|Primary|The Number of Subjects Who Were Growth Hormone (GH) Responders at Day 14 of the Treatment Period|A GH responder was defined as a subject with mean serum GH concentration ≤2.5 micrograms per litre (mcg/L) or >50% reduction from mean baseline GH concentration after a 6-day titration and an 8-day treatment period with BIM23B065. The mean serum concentration of GH was measured over 6 hours at baseline (Day -1) and on Day 14. The number of subjects who were GH responders at Day 14 of the treatment period is presented.|From baseline (Day -1) to Day 14.|The Efficacy Evaluable population consisted of all subjects with at least 1 BIM23B065 administration with available pharmacodynamic (PD) data and no protocol deviations with relevant impact on PD data, who had an evaluable primary efficacy endpoint (mean concentration of GH over 6 hours) at baseline and at Day 14.|||Participants|||Count of Participants
2540600|NCT03044886|Primary|Attachment Loss (AL)|Examination of AL was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects.|at baseline||||mm||Standard Deviation|Mean
2552756|NCT02790281|Primary|Exploratory: Levels of IL-6/sIL-6R Complex|Blood sample was taken for analysis of levels of IL-6/sIL6-R complex.|At Day 1|All eligible subjects with CRP >5 mg/L.|||pg/mL||Full Range|Median
2540583|NCT03045081|Secondary|Pain Severity, Enjoyment of Life Interference, General Activity Interference (PEG)|"Pain and pain interference were evaluated using the 3-item PEG scale. The pain intensity item was rated on an 11-point numeric rating scale, from 0 no pain to 10 pain as bad as you can imagine. Interference (with enjoyment of life and general activity) were rated from 0 does not interfere to 10 completely interferes. The PEG total (mean) score ranges from 0 to 10, where higher scores denote greater pain intensity and interference."|3 months and 6 months|While participants may have provided outcome data at all time points, they may have not provided sufficient data for on this scale within 2 months of primary outcome measure collection.|||score on a scale||Standard Deviation|Mean
2540584|NCT03045081|Secondary|Provider Satisfaction|Provider satisfaction with care process and PTSM|6 months|While providers were informed of study and coaching progress, we did not formally enroll providers in the study.||||||
2540585|NCT03045081|Secondary|Patient Satisfaction|"Patient satisfaction with care process. Note that we elected to evaluate patient satisfaction with their pain treatment in general, as opposed to the PTSM process specifically, in order to compare satisfaction between the study groups. Patient satisfaction was rated on an 11-point rating scale from 0 extremely dissatisfied to 10 extremely satisfied; higher scores denote higher satisfaction with pain treatment."|3 months and 6 months|While participants may have provided outcome data at all time points, they may have not provided satisfaction data for this item within 2 months of primary outcome measure collection.|||score on a scale||Standard Deviation|Mean
2540586|NCT03045081|Secondary|Patient-physician Interactions|Perceived efficacy in patient-physician interactions (PEPPI). Sum scores range from 5 to 25 with higher scores denoting greater perceived efficacy in patient-physician interactions.|3 months and 6 months|While participants may have provided data at all time points, they may have not provided sufficient data to calculate a score on this measure.|||score on a scale||Standard Deviation|Mean
2540587|NCT03045081|Secondary|Chronic Pain Acceptance|"Chronic Pain Acceptance Questionnaire with 2 subscales: Activity Engagement and Pain Willingness. Scores on the activity engagement subscale range from 0 to 66; scores on the pain willingness subscale range from 0 to 54; higher scores denote greater chronic pain acceptance."|3 months and 6 months|While participants may have provided data at all time points, they may have not provided sufficient data to calculate a score on this measure.|||score on a scale||Standard Deviation|Mean
2540588|NCT03045081|Primary|Chronic Pain Self-efficacy|Pain self-efficacy questionnaire (PSEQ); scores range from 0 to 60, with higher scores meaning greater self-efficacy (i.e., better outcome)|3 months and 6 months|Analyzed number from those who provided data at all 3 time points (0, 3 months, 6 months.); published manuscript describes methodology for assessing change over time in outcomes between the two groups (generalized estimating equations), using data from (1) all enrolled participants and (2) only participants who provided data at all time points.|||score on a scale||Standard Deviation|Mean
2540589|NCT03044886|Secondary|Bleeding Index (BI)|Examination of BI was performed with Williams probe, explored under the gingival margin about 1mm, and bleeding was observed after 30 seconds. BI was scored on a 0-5 scale, higher scores mean a worse outcome.|6 months after periodontal treatment||||score on a scale||Standard Deviation|Mean
2540590|NCT03044886|Secondary|Bleeding Index (BI)|Examination of BI was performed with Williams probe, explored under the gingival margin about 1mm, and bleeding was observed after 30 seconds. BI was scored on a 0-5 scale, higher scores mean a worse outcome.|3 months after periodontal treatment||||score on a scale||Standard Deviation|Mean
2540591|NCT03044886|Secondary|Bleeding Index (BI)|Examination of BI was performed with Williams probe, explored under the gingival margin about 1mm, and bleeding was observed after 30 seconds. BI was scored on a 0-5 scale, higher scores mean a worse outcome.|at baseline||||score on a scale||Standard Deviation|Mean
2540592|NCT03044886|Secondary|Alveolar Crest Height (ACH)|Panoramic radiographs were taken to evaluate alveolar crest height (ACH) with measuring software (i-Dixel, One Volume Viewer, version 6.00, J. MORITA MFG. CORP. Japan). The alveolar crest height is defined as the mean of the two-dimensional vertical distance between mesial and distal alveolar crest to apical point.|6 months after periodontal treatment||||mm||Standard Deviation|Mean
2540593|NCT03044886|Secondary|Alveolar Crest Height (ACH)|Panoramic radiographs were taken to evaluate alveolar crest height (ACH) with measuring software (i-Dixel, One Volume Viewer, version 6.00, J. MORITA MFG. CORP. Japan). The alveolar crest height is defined as the mean of the two-dimensional vertical distance between mesial and distal alveolar crest to apical point.|3 months after periodontal treatment||||mm||Standard Deviation|Mean
2540594|NCT03044886|Secondary|Alveolar Crest Height (ACH)|Panoramic radiographs were taken to evaluate alveolar crest height (ACH) with measuring software (i-Dixel, One Volume Viewer, version 6.00, J. MORITA MFG. CORP. Japan). The alveolar crest height is defined as the mean of the two-dimensional vertical distance between mesial and distal alveolar crest to apical point.|at baseline||||mm||Standard Deviation|Mean
2540595|NCT03044886|Secondary|Probing Depth (PD)|Examination of PD was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects.|6 months after periodontal treatment||||mm||Standard Deviation|Mean
2540596|NCT03044886|Secondary|Probing Depth (PD)|Examination of PD was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects.|3 months after periodontal treatment||||mm||Standard Deviation|Mean
2540597|NCT03044886|Secondary|Probing Depth (PD)|Examination of PD was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects.|at baseline||||mm||Standard Deviation|Mean
2540598|NCT03044886|Primary|Attachment Loss (AL)|Examination of AL was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects|6 months after periodontal treatment||||mm||Standard Deviation|Mean
2540599|NCT03044886|Primary|Attachment Loss (AL)|Examination of AL was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects.|3 months after periodontal treatment||||mm||Standard Deviation|Mean
2540601|NCT03044691|Primary|Feasibility of ResearchACTS Software in Clinical Assessment of Tobacco Use Measures|During the recruitment period, investigators will observe feedback from patients and clinic staff on how the feasibility of using the ResearchACTS software to capture tobacco use measures in a clinical setting. Feasibility of the software tool will be demonstrated by the ability of patients to complete the assessment within the timeframe afforded during a clinical visit.|Baseline|No-one was recruited into the control clinic arm.|||Participants|||Count of Participants
2540602|NCT03044574|Other Pre-specified|Duration of Inpatient Period of Treatment|The inpatient period of treatment suggests time from surgical intervention to discharge from the hospital or death.|time of discharge from the hospital or death, up to 45 days||||days||Inter-Quartile Range|Median
2540603|NCT03044574|Secondary|Number of Patients Who Died From VTE at 180 Days After Surgery|VTE related deaths that occurred during inpatients and outpatient period of treatment and were confirmed by autopsy|180 days||||Participants|||Count of Participants
2540604|NCT03044574|Secondary|Number of Patients With Symptomatic and Asymptomatic VTE Events at 180 Days After Surgery|Taking into account all symptomatic and asymptomatic VTE events confirmed by duplex ultrasound, CTPA, SPECT/CT, autopsy or other appropriate methods of diagnosis that occurred during the inpatient period of treatment and outpatient period of observation|180 days||||Participants|||Count of Participants
2540605|NCT03044574|Secondary|Number of Patients Who Died From VTE at 30 Days After Surgery|VTE related deaths that occurred during inpatients and outpatient period of treatment and were confirmed by autopsy|30 days||||Participants|||Count of Participants
2540606|NCT03044574|Secondary|Number of Patients With Symptomatic and Asymptomatic VTE Events at 30 Days After Surgery|Taking into account all VTE events: asymptomatic revealed by duplex ultrasound, symptomatic confirmed by duplex ultrasound, CTPA, SPECT/CT, autopsy in patients discharged from the hospital and still receiving inpatients care at 30 days after surgery.|30 days||||Participants|||Count of Participants
2540607|NCT03044574|Secondary|Number of Patients With Leg Skin Injury|Leg skin injury defined as any skin hyperemia, maceration, laceration, bubbles, erosion or ulceration in the zone of application for GCS and SCD on the lower limbs revealed by clinical inspection of the skin and soft tissues until discharge|time of discharge from the hospital or death, up to 45 days||||Participants|||Count of Participants
2540608|NCT03044574|Secondary|Number of Patients Died From Any Reason|Inpatient postoperative mortality: number of patients died from any reason during the inpatient period of treatment|time of discharge from the hospital or death, up to 45 days||||Participants|||Count of Participants
2540609|NCT03044574|Secondary|Number of Patients With Pulmonary Embolism|Symptomatic pulmonary embolism (PE) that occurred during the inpatient period of treatment and confirmed by computed tomography pulmonary angiogram (CTPA) or single-photon emission computed tomography with computed tomography (SPECT/CT) or autopsy|time of discharge from the hospital or death, up to 45 days||||Participants|||Count of Participants
2540610|NCT03044574|Secondary|Number of Patients With Isolated Calf Muscle Vein Thrombosis as Detected by Duplex Ultrasound|Isolated calf muscle vein thrombosis was defined as thrombosis of soleal, gastrocnemius or other calf muscle veins not extended into tibial, or peroneal, or popliteal veins. Detected by duplex ultrasound performed at baseline and then every 3-5 days after surgery until discharge.|time of discharge from the hospital or death, up to 45 days||||Participants|||Count of Participants
2540611|NCT03044574|Secondary|Number of Patients With Proximal Deep Venous Thrombosis as Detected by Duplex Ultrasound|Proximal deep vein thrombosis defined as thrombus of popliteal, femoral, iliac veins and/or inferior vena cava. Detected by duplex ultrasound performed at baseline and then every 3-5 days after surgery until discharge.|time of discharge from the hospital or death, up to 45 days||||Participants|||Count of Participants
2540612|NCT03044574|Primary|Number of Patients With Asymptomatic Venous Thrombosis of Lower Limbs as Detected by Duplex Ultrasound|Asymptomatic deep and/or superficial vein thrombosis of lower limbs detected by duplex ultrasound performed at baseline and then every 3-5 days after surgery until discharge.|time of discharge from the hospital or death, up to 45 days||||Participants|||Count of Participants
2540613|NCT03044431|Other Pre-specified|Number of Participants With Interstitial Lung Disease Reporting an Improvement in 6 Month-Post Treatment QOL Scores|Number of patients with a diagnosis of Interstitial Lung Disease who reported an improved perceived quality of life 6 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).|Measurements for ILD pre-treatment and then at 6 months post-treatment|23 patients with ILD completed a 6 month post-treatment QOL survey|||Participants|||Count of Participants
2540614|NCT03044431|Other Pre-specified|Number of Participants With Interstitial Lung Disease Reporting an Improvement in 3 Month-Post Treatment QOL Scores|Number of patients with a diagnosis of Interstitial Lung Disease who reported an improved perceived quality of life 3 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).|Measurements for ILD pre-treatment and then at 3 months post-treatment|28 patients with ILD completed a 3 month post-treatment QOL survey|||Participants|||Count of Participants
2540615|NCT03044431|Other Pre-specified|Number of Participants With COPD Reporting an Improvement in 6 Month-Post Treatment QOL Scores|Number of patients with a diagnosis of COPD who reported an improved perceived quality of life 6 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).|Measurements for COPD pre-treatment and then at 6 months post-treatment|101 patients with COPD completed a 6 month post-treatment QOL survey|||Participants|||Count of Participants
2540616|NCT03044431|Other Pre-specified|Number of Participants With COPD Reporting an Improvement in 3 Month-Post Treatment QOL Scores|Number of patients with a diagnosis of COPD who reported an improved perceived quality of life 3 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).|Measurements for COPD pre-treatment and then at 3 months post-treatment|120 patients with COPD completed a 3 month post-treatment QOL survey|||Participants|||Count of Participants
2540617|NCT03044431|Primary|Number of Participants Reporting an Improvement in 6 Month-Post Treatment QOL Scores, All Diagnoses|Number of patients in the total sample who reported an improved perceived quality of life 6 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).|Measurements pre-treatment and then at 6 months post-treatment among all diagnoses|124 patients completed a 6 month post-treatment QOL survey|||Participants|||Count of Participants
2540927|NCT03038867|Secondary|Testosterone Level at 0 Weeks|Testosterone level (ng/dL) at 0 weeks|0 weeks|3 patients in the Duloxetine group did not have testosterone measured at 0 weeks (patients were not available).|||ng/dL||Standard Deviation|Mean
2540618|NCT03044431|Primary|Number of Participants Reporting an Improvement in 3 Month-Post Treatment QOL Scores, All Diagnoses|Number of patients in the total sample who reported an improved perceived quality of life 3 months post-treatment as measured by the Clinical COPD Questionnaire (CCQ).|Measurements pre-treatment and then at 3 months post-treatment for all diagnoses|148 of 207 enrolled participants completed the 3 month post-treatment QOL survey|||Participants|||Count of Participants
2540619|NCT03044431|Primary|Change in FEV1 From Baseline Among COPD Patients|Change from baseline (among COPD patients only) as measured by pulmonary function testing/spirometry at baseline and again at 6 months post- treatment|Measurements pre-treatment and then at 6 months post- treatment|All patients with COPD were asked to provide a 6 month post-treatment pulmonary function test. 5 participants completed and returned the test.|||percentage of change in FEV1||Full Range|Mean
2540620|NCT03044353|Secondary|Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)|E/e' ratio was measured by ECHO at indicated time points. It had 2 separate measurements: lateral and septal. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.|Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Ratio||Standard Deviation|Mean
2540621|NCT03044353|Secondary|Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO|Left ventricle EDV is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole. EDV was measured by ECHO at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.|Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Milliliter||Standard Deviation|Mean
2540622|NCT03044353|Secondary|Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by CMR|Left ventricle EDV is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole. EDV was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.|Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Milliliter||Standard Deviation|Mean
2540623|NCT03044353|Secondary|Change From Baseline in Left Ventricular EF by ECHO|Left ventricular ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. EF was measured by ECHO at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.|Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Percentage of ejected blood||Standard Deviation|Mean
2540624|NCT03044353|Secondary|Change From Baseline in Left Ventricular Ejection Fraction (EF) by CMR|Left ventricular ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. EF was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.|Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Percentage of ejected blood||Standard Deviation|Mean
2540625|NCT03044353|Secondary|Change From Baseline in SV by ECHO|Stroke volume is the amount of blood ejected by the left ventricle in one contraction. SV was measured by ECHO at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.|Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Milliliter||Standard Deviation|Mean
2540626|NCT03044353|Secondary|Change From Baseline in Stroke Volume (SV) by CMR|Stroke volume is the amount of blood ejected by the left ventricle in one contraction. SV was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.|Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Milliliter||Standard Deviation|Mean
2540627|NCT03044353|Secondary|Change From Baseline in LV Twist Over Time|LV twist was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.|Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Degree||Standard Deviation|Mean
2540628|NCT03044353|Secondary|Change From Baseline in GLS by ECHO|Global Longitudinal Strain was measured by ECHO at indicated time points. GLS included speckle tracking by ECHO. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.|Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Percentage of myocardial shortening||Standard Deviation|Mean
2540629|NCT03044353|Secondary|Change From Baseline in Global Longitudinal Strain (GLS) by CMR|Global Longitudinal Strain was measured by CMR at indicated time points. GLS included feature tracking and tagging by CMR. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.|Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Percentage of myocardial shortening||Standard Deviation|Mean
2540630|NCT03044353|Secondary|AUC 0-t of GSK2315698 for Newly Diagnosed Mayo Stage II/IIIa AL Amyloidosis Participants|Blood samples were planned to be collected for evaluation of PK parameters including AUC0-t at indicated time points for GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants. However, no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'.|Day 1: Pre-dose; Day 2 (pre-dose and 2 hours post-dose); Day 3: Pre-dose in each session (each session of 24 days)|Safety Population. Data was not collected for this outcome due to blood samples were not collected to evaluate PK of GSK2315698 as no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'.||||||
2540631|NCT03044353|Secondary|Tmax of GSK2315698 for Newly Diagnosed Mayo Stage II/IIIa AL Amyloidosis Participants|Blood samples were planned to be collected for evaluation of PK parameters including Tmax at indicated time points for GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants. However, no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'.|Day 1: Pre-dose; Day 2: pre-dose and 2 hours post-dose; Day 3: Pre-dose in each session (each session of 24 days)|Safety Population. Data was not collected for this outcome due to blood samples were not collected to evaluate PK of GSK2315698 as no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'.||||||
2540632|NCT03044353|Secondary|Cmax of GSK2315698 for Newly Diagnosed Mayo Stage II/IIIa AL Amyloidosis Participants|Blood samples were planned to be collected for evaluation of PK parameters including Cmax at indicated time points for GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants. However, no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants.'|Day 1: Pre-dose; Day 2 (pre-dose and 2 hours post-dose); Day 3: Pre-dose in each session (each session of 24 days)|Safety Population. Data was not collected for this outcome due to blood samples were not collected to evaluate PK of GSK2315698 as no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'.||||||
2540633|NCT03044353|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC 0-t) of GSK2398852|Blood samples were collected for evaluation of PK parameters including AUC 0-t at indicated time points. Geometric mean and geometric coefficient of variation of AUC0-t is presented.|Session 1 to 6: Day 1 (Pre-dose, 6, 8, 12 hour), Day 2, Day 3 (Pre-dose and at 6 hour), Day 4, Day 7 and Day 11|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Hour*micrograms per milliliter (h*ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2540634|NCT03044353|Secondary|Time Associated With Cmax (Tmax) of GSK2398852|Blood samples were collected for evaluation of PK parameters including Tmax at indicated time points. Median and full range of Tmax is presented.|Session 1 to 6: Day 1 (Pre-dose, 6, 8, 12 hour), Day 2, Day 3 (Pre-dose and at 6 hour), Day 4, Day 7 and Day 11|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Hour||Full Range|Median
2540635|NCT03044353|Secondary|Maximum Concentration (Cmax) of GSK2398852|Blood samples were collected for evaluation of Pharmacokinetic (PK) parameters including Cmax at indicated time points. Geometric mean and geometric coefficient of variation of Cmax is presented.|Session 1 to 6: Day 1 (Pre-dose, 6, 8, 12 hour), Day 2, Day 3 (Pre-dose and at 6 hour), Day 4, Day 7 and Day 11|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Micrograms per milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2540636|NCT03044353|Secondary|Change From Baseline in Inflammatory Biomarkers Over Time|Blood samples were collected for assessment of inflammatory biomarkers which included C-Reactive protein (CRP), high-sensitivity C-reactive protein (hsCRP), serum amyloid A protein (SAA). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.|Baseline (Day -1) and Session 1 to 6: Day 1 (predose, 2,4,8 hours), Day 2, Day 3 (predose, 2,4,8 hours), Day 5, Day 6|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)|||Milligrams per Liter (mg/L)||Standard Deviation|Mean
2540637|NCT03044353|Secondary|Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time|Blood samples were collected for assessment of Fluid Phase Complement Markers which included total complement (CH50). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.|Baseline (Day -1) and Session 1 to 6: Day 1 (predose, 2,4,8 hours), Day 2, Day 3 (predose, 2,4,8 hours), Day 5, Day 6|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Units per milliliter||Standard Deviation|Mean
2540638|NCT03044353|Secondary|Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time|Blood samples were collected for assessment of Fluid Phase Complement Markers which included complement 4 (C4). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.|Baseline (Day -1) and Day 2, Day 5, Day 6|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Grams per Liter (g/L)||Standard Deviation|Mean
2540681|NCT03043534|Secondary|Investigator Global Assessment (IGA)|Investigator Global Assessment (IGA) will measure disease severity using a scale 0 (Clear) - 5 (Very Severe) with the lower score grade denoting better outcome measures.|Baseline, 6 weeks||||units on a scale||Standard Deviation|Mean
2540682|NCT03043534|Secondary|Lesions|Lesions will be measured by counting papules, pustules, ingrown hairs, and Hyerpigmentation.|Baseline, 6 weeks||||lesions||Standard Deviation|Mean
2540639|NCT03044353|Secondary|Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time|Blood samples were collected for assessment of Fluid Phase Complement Markers which included complement 3 (C3). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.|Baseline (Day -1) and Session 1 to 6: Day 1 (predose, 2,4,8 hours), Day 2, Day 3 (predose, 2,4,8 hours), Day 5, Day 6|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Grams per Liter (g/L)||Standard Deviation|Mean
2540640|NCT03044353|Secondary|Change From Baseline in Plasma Cytokines Over Time|Blood samples were collected for assessment of plasma cytokines biomarkers which included Tumor Necrosis Factor (TNF), Interleukin 1 beta (IL-1 beta), IL-6, IL-10, Interferon gamma (INF gamma), IL-12, IL-13, IL-2, IL-4 and IL-8. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. Absolute values below the lower limit of quantification (LLQ) were imputed with half the LLQ and those above the upper limit of quantification (ULQ) were imputed with the ULQ.|Baseline (Day -1) and Session 1: Day 1 (predose, 1,3,6 hours), Day 2, Day 3 (predose, 1,3,6 hours), Day 4, Day 5; Session 2 to 6: Day -2, Day 1 (predose, 1,3,6 hours), Day 2, Day 3 (predose, 1,3,6 hours), Day 4, Day 5|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Nanograms per liter (ng/L)||Standard Deviation|Mean
2540641|NCT03044353|Secondary|Number of Participants With Abnormalities in Immunohistochemical Examination of Blood Biomarkers|Blood samples were to be collected along with each skin biopsy sample for immunohistochemical examination of blood biomarkers only on any rash development (>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist.|Up to the end of study (Up to 369 days)|Safety Population. Data was not collected due to project termination.||||||
2540642|NCT03044353|Secondary|Number of Participants With Abnormalities in Histopathological Examination of Blood Biomarkers|Blood samples were to be collected along with each skin biopsy sample for histopathological examination of blood biomarkers only on any rash development (>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist.|Up to the end of study (Up to 369 days)|Safety Population. Data was not collected due to project termination.||||||
2540643|NCT03044353|Secondary|Number of Participants With Abnormalities in Immunohistochemical Examination of Skin Biopsies|Skin biopsy samples were collected for immunohistochemical examination only on any rash development (>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist. Number of participants with abnormalities in immunohistochemical examination of skin biopsies are presented.|Up to the end of study (Up to 369 days)|Safety Population|||Participants|||Count of Participants
2540644|NCT03044353|Secondary|Number of Participants With Abnormalities in Histopathological Examination of Skin Biopsies|Skin biopsy samples were collected for histopathological examination only on any rash development (>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist. Number of participants with abnormalities in histopathological examination of skin biopsies are presented.|Up to the end of study (Up to 369 days)|Safety Population|||Participants|||Count of Participants
2540645|NCT03044353|Primary|Number of Participants With Skin Rashes Classified Using CTCAE|Skin rash was an event of special interest. All the events of rashes were graded for their severity using CTCAE version 4.0 . Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life threatening, Grade 5: death. Higher the grade, more severe the symptoms. Only Rashes that were associated with study drug were categorised as Rash for CTCAE and are presented here. Number of participants with skin rashes classified by their maximum grade are presented.|Up to 56 days after the last dosing session (up to 265 days)|Safety Population. Only those participants with data available at the specified time point was analyzed.|||Participants|||Count of Participants
2540646|NCT03044353|Primary|Number of Participants With Skin Rashes|Skin rash was an event of special interest. Only Rashes that were associated with study drug were categorised as Rash for Common Terminology Criteria for Adverse Events (CTCAE) and are presented. Number of participants with on-treatment skin rash AEs are presented.|Up to 56 days after the last dosing session (up to 265 days)|Safety Population|||Participants|||Count of Participants
2540647|NCT03044353|Primary|Number of Participants for Which Unscheduled Echocardiography (ECHO) Was Performed for Safety Reasons|Echocardiography was performed by a qualified echocardiographer or cardiologist during the study. Number of participants with unscheduled echocardiograms performed for safety reasons have been presented.|Up to the end of study (Up to 369 days)|Safety Population. Only those participants with data available at the specified time point was analyzed.|||Participants|||Count of Participants
2540648|NCT03044353|Primary|Number of Participants With Abnormalities During Cardiac Monitoring|Lead II telemetry and cardiac monitoring devices were used for electrical cardiac monitoring during the study. The number of participants with worst case post-Baseline abnormalities during cardiac monitoring as per investigator's assessment have been reported and categorized as Abnormal-clinically significant and Abnormal-not clinically significant.|Up to the end of study (Up to 369 days)|Safety Population. Only those participants with data available at the specified time point was analyzed.|||Participants|||Count of Participants
2540649|NCT03044353|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Twelve-lead ECGs were performed during the study using an automated ECG machine. The number of participants with worst case post-Baseline abnormal ECG findings were reported and categorized as abnormal-clinically significant and abnormal-not clinically significant.|Up to the end of study (Up to 369 days)|Safety Population|||Participants|||Count of Participants
2540650|NCT03044353|Primary|Number of Participants With Pulse Rate Shifts From Baseline Relative to PCI Criteria|Vital signs including pulse rate were measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in pulse rate from baseline to worst case post baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to its PCI criteria. PCI criteria for pulse rate was: high: >140 beats per minute (bpm); low: <35 bpm.|Up to the end of study (Up to 369 days)|Safety Population|||Participants|||Count of Participants
2540728|NCT03042559|Secondary|Hip External Rotation ROM|To measure the External rotation of hip in sitting natural position with hip and knee on 90 degree flexion|baseline||||degree||Standard Deviation|Mean
2540651|NCT03044353|Primary|Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria|Vital signs including SBP and DBP were measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in SBP and DBP from baseline to worst case post baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to PCI criteria. PCI criteria for SBP was: high: >180 millimeter of mercury (mmHg); low: <90 mmHg. PCI criteria for DBP was: high: >110 mmHg; low: <30 mmHg.|Up to the end of study (Up to 369 days)|Safety Population|||Participants|||Count of Participants
2540652|NCT03044353|Primary|Number of Participants With Body Temperature Shifts From Baseline Relative to Potential Clinical Importance (PCI) Criteria|Vital signs including body temperature was measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in body temperature from Baseline to worst case post Baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to PCI criteria. PCI criteria for body temperature was: high: >37.5 degree Celsius; low: not applicable.|Up to the end of study (Up to 369 days)|Safety Population|||Participants|||Count of Participants
2540653|NCT03044353|Primary|Number of Participants With Abnormal Urinalysis Results for Character Parameters|Urine samples were collected to assess character parameters which included Cellular Casts, Erythrocytes, Glucose, Ketones, Leukocytes and Occult Blood. Number of participants with abnormal urinalysis results are presented. Data for worst case post Baseline is presented.|Up to the end of study (Up to 369 days)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2540654|NCT03044353|Primary|Number of Participants With Abnormal Urinalysis Results|Urine samples were collected to assess potential of hydrogen (pH), specific gravity, albumin excretion rate, creatinine excretion rate and protein excretion rate. Abnormal urinalysis results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories.|Up to the end of study (Up to 369 days)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2540655|NCT03044353|Primary|Number of Participants With Abnormal Clinical Chemistry Values|Blood samples were collected for assessment of clinical chemistry parameters, which included aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), urea, creatinine, glucose, chloride, creatinine kinase, potassium, sodium, calcium, total carbon dioxide (CO2), urate, total and direct bilirubin, total protein and albumin. Abnormal laboratory results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories.|Up to the end of study (Up to 369 days)|Safety Population|||Participants|||Count of Participants
2540656|NCT03044353|Primary|Number of Participants With Abnormal Hematology Values|Blood samples were collected for assessment of hematology parameters, which included platelet count, hemoglobin, hematocrit, erythrocytes, reticulocyte count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, leukocytes and basophils. Abnormal laboratory results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories.|Up to the end of study (Up to 369 days)|Safety Population|||Participants|||Count of Participants
2540657|NCT03044353|Primary|Number of Participants With Any Serious Adverse Events (SAEs)|AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, events associated with liver injury and impaired liver function, or any other situation according to medical or scientific judgment were categorized as SAE. Number of participants with any SAEs during study are presented.|Up to the end of study (Up to 369 days)|Safety Population|||Participants|||Count of Participants
2540658|NCT03044353|Primary|Number of Participants With Any On-treatment Adverse Events (AEs)|AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any on-treatment AEs are presented.|Up to 56 days after the last dosing session (up to 265 days)|Safety Population|||Participants|||Count of Participants
2540659|NCT03044353|Primary|Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up|Left ventricular mass was measured by Cardiac Magnetic Resonance (CMR) imaging to assess reduction in cardiac amyloid load after repeated administration of anti-SAP treatment. Each CMR imaging session took approximately 45-60 minutes, with a maximum scan time inside of the scanner of 90 minutes. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. Safety Population comprised of all participants who received at least one dose of study treatment (any dose of CPHPC [GSK2315698] or anti-SAP mAb [GSK2398852]).|Baseline (Day -1) and Session 2 Day 24, Session 3 Day 24, Session 4 Day 24, Session 5 Day 24, 8 Weeks Follow-up|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Grams||Standard Deviation|Mean
2540660|NCT03044197|Secondary|Comparison of UTI Incidence in Arm A mpMRI+ and Arm B|Number of confirmed UTIs|From the time of biopsy through 4 weeks post-biopsy||||Participants|||Count of Participants
2540729|NCT03042559|Secondary|Hip Internal Rotation ROM|To measure the internal rotation of hip in sitting natural position with hip and knee on 90 degree flexion|4 weeks||||degree||Standard Deviation|Mean
2540730|NCT03042559|Secondary|Hip Internal Rotation ROM|To measure the internal rotation of hip in sitting natural position with hip and knee on 90 degree flexion|2 weeks||||degree||Standard Deviation|Mean
2540661|NCT03044197|Secondary|Overall Detection Rate of Prostate Cancer Between Arm A mpMRI+ and Arm B|Number of overall positive prostate cancer (Combined positive and clinically significant positive results) Not all positive prostate biopsies are considered clinically significant. Clinically significant results indicate further work up and/or treatment. Physicians and patients may choose not to just monitor non-clinically significant prostate results for future changes. The overall detection rate will report the total number of both non-clinically significant positive results and clinically significant results.|Within 2-4 wks from biopsy||||Participants|||Count of Participants
2540662|NCT03044197|Primary|Number of Participants With Clinically Significant Prostate Cancer|Number of subjects with positive clinically significant prostate cancer results|Within 2-4 wks after biopsy||||Participants|||Count of Participants
2540663|NCT03044106|Secondary|Mean Difference Pre/Post KEA, Stratified by History of Prior Hamstring Strain|Mean difference between active CLRT and Sham in hamstring flexibility (KEA) stratified by a history of prior hamstring injury. 8 participants reported prior injuries, 36 reported having no prior hamstring strain.|At baseline and immediately after intervention|Mean difference in pre/post KEA after receiving active CLRT and Sham in hamstring flexibility (KEA), stratified by a history of prior hamstring injury.|||degrees||Standard Deviation|Mean
2540664|NCT03044106|Secondary|Pain Pressure Threshold|PPT is a reliable, accurate and valid method for measuring muscle pain sensitivity and response to treatment. In order to determine PPT, the researcher will apply the tip of the algometer to a tender spot in the participant's hamstrings and increase the amount of pressure until the participant verbally informs the researcher when the sensation of pressure became pain. At this point the algometer is removed and the peak force recorded. The mean of three repeated measures will be reported. An increase in PPT signifies an increase in pain tolerance and a decrease in pain sensitivity.|At baseline and immediately after intervention|Intention to treat.|||kgf||Standard Deviation|Mean
2540665|NCT03044106|Secondary|Handheld Dynamometry|Handheld Dynamometry (HHD) is measures peak muscle contraction. The measurements will be recorded as kilograms (kg) and higher scores indicate higher muscle strength. The subject will be prone on the table with right leg bent to 90° and will maximally contract the hamstring muscle for 4-5 seconds against the HHD device. The investigator will record the mean value of three attempts. Higher scores indicate greater strength.|At baseline and immediately after intervention|Intention to treat.|||Kilograms||Standard Deviation|Mean
2540666|NCT03044106|Primary|90-90 Knee Extension Angle Test|Knee Extension Angle (KEA) test is a functional test designed to assess lower extremity flexibility and is considered the gold standard test for assessing hamstring length. Results will be recorded as degrees of knee flexion angle. A clinically significant effect size is an increase of 5 degrees.|At baseline and immediately after intervention|Analysis was conducted on intention to treat.|||degrees||Standard Deviation|Mean
2540667|NCT03044028|Secondary|KOOS Pain|Measure pain at 12 weeks postoperative using Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscore. Change in total score from baseline to 12 weeks postoperative score. Minimum value is 0, maximum value is 100, and higher values mean greater improvement over baseline total score.|12 weeks|Numbers do not match Participant Flow because data were missing.|||z-score||Standard Deviation|Mean
2540668|NCT03044028|Secondary|KOOS - PS|Functional outcomes using the Knee Injury and Osteoarthritis Outcome Score (KOOS) Physical Function Shortform (PS) questionnaire. Change in total score from baseline to 12 weeks postoperative score. Minimum value is 0, maximum value is 100, and higher values mean greater improvement over baseline total score.|12 weeks|Numbers do not match Participant Flow because data were missing.|||units on a scale||Standard Deviation|Mean
2540669|NCT03044028|Secondary|Number of Outpatient Therapy Visits (Patient Questionnaire)|Difference in number of outpatient therapy visits among the treatment groups|12 weeks||||visits||Standard Deviation|Mean
2540670|NCT03044028|Secondary|Number of Patients Readmitted to Hospital|Number of all-cause readmissions to the hospital|12 weeks||||Participants|||Count of Participants
2540671|NCT03044028|Secondary|Number of Patients Discharged to Extended Care Facility|"Patent discharge other than home to extended care facility"|12 weeks||||Participants|||Count of Participants
2540672|NCT03044028|Secondary|Hospital Length of Stay (Days)|differences in length of stay between the treatment groups|12 weeks||||days||Standard Deviation|Mean
2540673|NCT03044028|Secondary|Visual Analogue Scale (VAS) Pain Level (0-10 Scale)|Differences in VAS scores between the treatment groups from baseline to 12 weeks postop. Higher score represents worse pain.|12 weeks|Numbers do not match Participant Flow because data were missing.|||units on a scale||Standard Deviation|Mean
2540674|NCT03044028|Secondary|Knee Active Range of Motion (Extension, Flexion) in Degrees|Measure rage of motion differences between the treatment groups|12 weeks||||degrees||Standard Deviation|Mean
2540675|NCT03044028|Primary|Quadriceps Femoris Muscle (QFM) Strength (Dynamometer Quad Strength Lbs)|measure change in muscle strength (QFM) - difference from baseline measure to 6 weeks postoperative|6 weeks|Numbers do not match Participant Flow because data were missing.|||lbs||Standard Deviation|Mean
2540676|NCT03043885|Secondary|Bone Mineral Density|The bone mineral density (measured via micro-CT) at healed extraction sockets|3 months||||mg/cm3||Standard Deviation|Mean
2540677|NCT03043885|Primary|Percentage of Vital Bone|Percentage of vital bone at healed extraction socket|3 months||||percentage of vital bone||Standard Deviation|Mean
2540678|NCT03043599|Secondary|Overall Survival (OS)|OS is defined as the duration from date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact.|1 year||||months||95% Confidence Interval|Median
2540679|NCT03043599|Primary|Phase II: Progression Free Survival (PFS)|PFS is defined as the duration from date of registration to date of first documentation of progression assessed by local investigator or symptomatic deterioration (as defined above) or death due to any cause.|6 months||||months||95% Confidence Interval|Median
2540680|NCT03043599|Primary|Phase I: Confirmation of Recommended Phase II Dose|Recommended Phase II dose of ipilimumab and nivolumab among participants treated with combined thoracic radiation therapy (30 Gy in 10 fractions) and nivolumab/ipilimumab following standard treatment with 4-6 cycles of platinum-based chemotherapy. Investigators will initially enroll 6 patients and wait until completion of the 13-week safety observation period following initiation of ipilimumab + nivolumab combination treatment.|13 weeks||||mg/kg dose|||Number
2540683|NCT03043534|Secondary|Quality of Life Survey|"Quality of Life Survey will measure subjects' overall perception. For Shaving Experience, the total score could range from 6-42 with lower scores denoting better outcome measures.~For Shaving Frustration, the total score could range from 3-21 with higher scores denoting better outcome measures.~For Achieving Results, the total score could range from 3-21 with lower scores denoting better outcome measures.~For Skin Feel, the total score could range from 3-21 with lower scores denoting better outcome measures.~For Skin-Confidence, the total score could range from 4-28 with lower scores denoting better outcome measures.~For Social Interactions, the total score could range from 6-42 with lower scores denoting better outcome measures."|Baseline, 6 weeks||||score on a scale||Standard Deviation|Mean
2540684|NCT03043534|Secondary|Patient Global Severity Assessment (Degree of Itching, Burning and Stinging)|Patient Global Severity Assessment measures itching/burning/stinging on the following scales:1 (no itching/no burning/no stinging at all) to 5 (very severe) the total score could range from 1-5 with the lower scores promoting a better outcome.|Baseline, 6 weeks||||score on a scale||Standard Deviation|Mean
2540685|NCT03043534|Primary|Patient Global Severity Assessment- Mechanics of Shaving|"A total of the Patient's Global Assessment of mechanics of shaving based on following scale:~How easy is it to… (please rank each phrase from 1 to 4; 1 = very easy, 2 = easy, 3 = difficult, 4 = very difficult)~A) get a smooth shave after shaving? __________~B) shave stubborn hairs? __________~C) shave against the grain with little irritation? __________~D) shave with the grain with little irritation? __________~E) glide comfortably over your skin with the razor blade?~For each subject, the total score could range from 5 -20, with lower numbers indicating better shave mechanics"|Baseline, 6 weeks||||score on a scale||Standard Deviation|Mean
2540686|NCT03043105|Secondary|Number of Participants With Treatment-related Serious Adverse Events as Assessed by CTCAE v4.0 ( ≥3 Grade)|Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0 (patients with grades ≥3 would be included)|From initiation of TCP regimen to 3 months after the end of treatment or to time point of the initiation of second line therapy.||||Participants|||Count of Participants
2540687|NCT03043105|Secondary|Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 ( ≥1 Grade)|Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (patients with grades ≥1 would be included)|From initiation of TCP regimen to 3 months after the end of treatment or to time point of the initiation of second line therapy.||||Participants|||Count of Participants
2540688|NCT03043105|Secondary|Change in SF-36 Score|SF-36 score is a self-administered scoring system which reflects a patient's general health status. SF-36 contains 8 dimensions, including physical functioning, role physical, role emotional, vitality, mental health, social functioning, bodily pain, and general health. Each dimension ranges from 0 to 100. Higher scores mean better outcome. SF-36 score at baseline was compared with SF-36 score at 24 weeks.|From baseline to 24 weeks after treatment.|Each patient is assessed by SF-36 scoring system, which contains 8 dimensions, including physical functioning, role physical, role emotional, vitality, mental health, social functioning, bodily pain, and general health.|||score on a scale||Standard Deviation|Mean
2540689|NCT03043105|Secondary|Overall Survival|Overall survival, defined as the time to patients' death, is measured.|From date of randomization until the date of death from any cause, assessed up to 36 months.||||months||95% Confidence Interval|Mean
2540690|NCT03043105|Secondary|Progression-free Survival|Progression-free survival (PFS) is defined as the time to death or treatment failure. Treatment failure is defined as: sustained increase in grade ≥2 disease-related symptoms persisting ≥12 weeks; new disease-related grade ≥3 symptoms; sustained >1 point increase in ECOG-PS persisting for ≥12 weeks; radiological progression; or initiation of another treatment for MCD.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months||||months||95% Confidence Interval|Mean
2540691|NCT03043105|Primary|Number of Patients With Durable Tumor and Symptomatic Response|Durable tumor and symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman's disease, sustained for at least 18 weeks. PR: >=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 6 months.|From baseline to the time point when a patient achieves treatment response for 24 weeks.||||Participants|||Count of Participants
2540692|NCT03043079|Secondary|Incidental Findings and Ultrasound Safety|Any reported incidental findings or health related issues from being subjected to the study-related ultrasound imaging|1 year||||Participants|||Number
2540693|NCT03043079|Secondary|Difference in Shear Wave Velocity Measurement in the Abdominal Wall Pre and Post Hernia Repair|Differences in the shear wave velocity measurements in the abdominal wall of preoperative hernia scan and postoperative scan 26 weeks after surgical ventral hernia repair|through study completion, an up to 26 weeks postoperative||||meters per second||Standard Deviation|Mean
2540694|NCT03043079|Primary|Difference in the Shear Wave Velocity Measurements in the Abdominal Wall Between Ventral Hernia and Healthy Abdominal Wall|Differences in the shear wave velocity measurements in the abdominal wall of healthy and ventral hernia patients|study intiation ultrasound scan lasting up to 45 minutes|21 ventral hernia age and BMI matched to 14 health volunteers with 10 active volunteers|||meters per second||Standard Deviation|Mean
2540695|NCT03042910|Secondary|Accumulation Ratio (Rac) of Plasma Talazoparib on Day 22|Rac was calculated as, area under the curve from time zero to end of dosing interval on Day 22 (AUCtau) divided by area under the curve from time zero to end of dosing interval on Day 1 (AUCtau). Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 6 hours. Day 22 subpopulation: amongst the participants with reported pharmacokinetic (PK) parameters on Day 22, exclusion of values from the summary statistics calculations due to dose modifications (eg, dose interruptions, dose reductions) was handled on a case by case basis, resulting in a subpopulation of participants with no prior dose modifications.|Pre-dose, 1, 2, 4, and 6 hours post-dose on Day 22|Pharmacokinetic (PK) analysis population: all participants who had sufficient concentration data to derive at least 1 PK parameter. Here, number analyzed signifies participants with available date for the specified time point.|||ratio||Full Range|Median
2540696|NCT03042910|Secondary|Apparent Clearance After Oral Dose (CL/F) of Plasma Talazoparib on Day 22|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed. Day 22 subpopulation: amongst the participants with reported pharmacokinetic (PK) parameters on Day 22, exclusion of values from the summary statistics calculations due to dose modifications (eg, dose interruptions, dose reductions) was handled on a case by case basis, resulting in a subpopulation of participants with no prior dose modifications.|Pre-dose, 1, 2, 4, and 6 hours post-dose on Day 22|Pharmacokinetic (PK) analysis population: all participants who had sufficient concentration data to derive at least 1 PK parameter. Here, number analyzed signifies participants with available date for the specified time point.|||liter/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2540697|NCT03042910|Secondary|Predose Concentration (Ctrough) of Plasma Talazoparib on Day 22|Day 22 subpopulation: amongst the participants with reported pharmacokinetic (PK) parameters on Day 22, exclusion of values from the summary statistics calculations due to dose modifications (eg, dose interruptions, dose reductions) was handled on a case by case basis, resulting in a subpopulation of participants with no prior dose modifications.|Pre-dose, Day 22|Pharmacokinetic (PK) analysis population: all participants who had sufficient concentration data to derive at least 1 PK parameter.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2540698|NCT03042910|Secondary|Time for Cmax (Tmax) of Plasma Talazoparib on Day 1 and Day 22|Day 22 subpopulation: amongst the participants with reported pharmacokinetic (PK) parameters on Day 22, exclusion of values from the summary statistics calculations due to dose modifications (eg, dose interruptions, dose reductions) was handled on a case by case basis, resulting in a subpopulation of participants with no prior dose modifications.|Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Day 1; pre-dose, 1, 2, 4, and 6 hours post-dose on Day 22|Pharmacokinetic (PK) analysis population: all participants who had sufficient concentration data to derive at least 1 PK parameter.|||hour (hr)||Full Range|Median
2540699|NCT03042910|Secondary|Maximum Plasma Concentration (Cmax) of Plasma Talazoparib on Day 1 and Day 22|Day 22 subpopulation: amongst the participants with reported pharmacokinetic (PK) parameters on Day 22, exclusion of values from the summary statistics calculations due to dose modifications (eg, dose interruptions, dose reductions) was handled on a case by case basis, resulting in a subpopulation of participants with no prior dose modifications.|Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Day 1; pre-dose, 1, 2, 4, and 6 hours post-dose on Day 22|Pharmacokinetic (PK) analysis population: all participants who had sufficient concentration data to derive at least 1 PK parameter. Here, number analyzed signifies participants with available date for the specified time point.|||picogram/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2540700|NCT03042910|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to 24 Hours After Dosing (AUC24) of Plasma Talazoparib on Day 1 and Day 22|Day 22 subpopulation: amongst the participants with reported pharmacokinetic (PK) parameters on Day 22, exclusion of values from the summary statistics calculations due to dose modifications (eg, dose interruptions, dose reductions) was handled on a case by case basis, resulting in a subpopulation of participants with no prior dose modifications.|Pre-dose, 1, 2, 4, 6, and 24 hours post-dose on Day 1; pre-dose, 1, 2, 4, and 6 hours post-dose on Day 22|Pharmacokinetic (PK) analysis population: all participants who had sufficient concentration data to derive at least 1 PK parameter. Here, number analyzed signifies participants with available date for the specified time point.|||picogram*hour/milliliter (pg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2540701|NCT03042910|Secondary|Number of Participants With Clinically Significant Laboratory Test Abnormalities|Laboratory test included: hematology (hematocrit, hemoglobin, mean corpuscular volum, red blood cell count, platelet count, white blood cell count with differential [total neutrophils, eosinophils, monocytes, basophils, and lymphocytes]),chemistry (albumin, total protein, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, total bilirubin, blood urea nitrogen, creatinine, non-fasting glucose, carbon dioxide, calcium, chloride, magnesium, phosphate, potassium, sodium and lactate dehydrogenase), and additional tests (urine or serum pregnancy tests for women of childbearing potential). Clinically significant laboratory abnormality was determined by the investigator.|Baseline to follow-up (30 days post last dose on Day 22, i.e. up to Day 52)|Safety population: all participants who received any amount of talazoparib.|||Participants|||Count of Participants
2540702|NCT03042910|Secondary|Number of Participants With Clinically Notable Changes in Vital Signs Measurements|Clinically notable changes included: High systolic blood pressure (SBP):>=155 millimeters of mercury (mmHg) with increase >=30 mmHg, low SBP <=90 mmHg with decrease >=20 mmHg, Both high and low SBP (i.e high SBP >=155 mmHg with increase >=30 mmHg and low SBP <=90 mmHg with decrease >=20 mmHg), High diastolic blood pressure (DBP):>=100 mmHg with increase >=15 mmHg), Low DBP (<=50 mmHg with decrease >=15 mmHg), Both high and low DBP, Heart rate >=100 bpm with increase >=30 bpm, Heart rate <=50 bpm with decrease >=15 bpm, Respiratory rate >=25 bpm, Respiratory rate <10 bpm, Oral body temperature >39 degree and Oral body temperature <=35 degree.|Screening (Day -29 to Day -2) to follow-up (30 days post last dose on Day 22)|Safety population: all participants who received any amount of talazoparib.|||Participants|||Count of Participants
2540703|NCT03042910|Secondary|Number of Participants With Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, AEs of Special Interest, and Deaths|An adverse event(AE)was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not related to the study drug. A serious adverse event(SAE)was an AE that resulted in: death; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; congenital anomaly/birth defect; was life-threatening (immediate risk of death); hospitalization or prolongation of existing hospitalization; or considered to be an important medical event. Treatment-emergent AEs (TEAEs) are AEs occurred on or after the administration of study drug. AEs related to study drug was any AE with at least a possible relationship to the study drug as assessed by the investigator. AEs of special interest were diagnosis of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), and abnormal liver test results that met predefined criteria.|Day 1 to follow-up (30 days post last dose, i.e. up to 52 days)|Safety population: all participants who received any amount of talazoparib.|||Participants|||Count of Participants
2540704|NCT03042910|Secondary|Number of Participants With Clinically Significant Findings in 12-lead Electrocardiogram (ECG) Parameters Meeting Predefined Criteria|Criteria for clinically significant: Maximum QTcF >450 msec, Maximum QTcF >480 msec, Maximum QTcF >500 msec, Maximum QTcB >450 msec, Maximum QTcB >480 msec, Maximum QTcB >500 msec, Maximum QT Interval >500 msec, Maximum QTcF Increase <=30 msec, Maximum QTcF Increase 30 to <=60 msec, Maximum QTcF Increase <=60 msec, Maximum PR interval increase >200 msec and >=25%, Maximum QRS interval increase >100 msec and >=25%, Maximum heart rate increase >100 bpm and >25% and Maximum heart rate decrease <50 bpm and >25%.|Baseline (mean of all ECGs on Day -1 and pre-dose on Day 1) to Day 22|Electrocardiographic analysis population: all enrolled participants who received at least 1 dose of talazoparib, and had at least 1 available baseline and 1 on-treatment electrocardiogram (ECG) data.|||Participants|||Count of Participants
2540705|NCT03042910|Secondary|Number of Participants With Treatment-emergent Abnormalities in 12-lead Electrocardiogram (ECG) Morphpology|"Morphological analyses were performed with regard to the ECG waveform interpretation as defined by the central ECG laboratory's cardiologist. Numbers of participants with new onsets for the following variables were counted: atrial fibrillation or flutter, second-degree heart block, third degree heart block, complete right bundle branch block, complete left bundle branch block, ST segment depression, ST segment elevation, T-wave abnormalities (negative T waves only), myocardial infarction pattern, and any new abnormal U waves. New was defined as not present on any baseline ECG but present on any on-treatment ECG. Number of participants with abnormality in any of the variables were reported."|Baseline to Day 22|Electrocardiographic analysis population: all enrolled participants who received at least 1 dose of talazoparib, and had at least 1 available baseline and 1 on-treatment electrocardiogram (ECG) data.|||Participants|||Count of Participants
2540706|NCT03042910|Secondary|Time-matched Mean Change From Baseline in RR Interval|RR interval is the time elapsing between two consecutive R waves in the electrocardiogram.|Baseline (Day -1 time matched for each time point); 1, 2, 4 and 6 hours post-dose on Day 1; pre-dose on Day 2; pre-dose, 1, 2, 4 and 6 hours post-dose on Day 22|Electrocardiographic analysis population: all enrolled participants who received at least 1 dose of talazoparib, and had at least 1 available baseline and 1 on-treatment electrocardiogram (ECG) data.|||msec||90% Confidence Interval|Mean
2540707|NCT03042910|Secondary|Time-matched Mean Change From Baseline in QT Interval|QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole.|Baseline (Day -1 time matched for each time point); 1, 2, 4 and 6 hours post-dose on Day 1; pre-dose on Day 2; pre-dose, 1, 2, 4 and 6 hours post-dose on Day 22|Electrocardiographic analysis population: all enrolled participants who received at least 1 dose of talazoparib, and had at least 1 available baseline and 1 on-treatment electrocardiogram (ECG) data.|||msec||90% Confidence Interval|Mean
2540708|NCT03042910|Secondary|Time-matched Mean Change From Baseline in QRS Interval|QRS interval is the time from electrocardiogram Q wave to the end of the S wave, corresponding to ventricle depolarization.|Baseline (Day -1 time matched for each time point); 1, 2, 4 and 6 hours post-dose on Day 1; pre-dose on Day 2; pre-dose, 1, 2, 4 and 6 hours post-dose on Day 22|Electrocardiographic analysis population: all enrolled participants who received at least 1 dose of talazoparib, and had at least 1 available baseline and 1 on-treatment electrocardiogram (ECG) data.|||msec||90% Confidence Interval|Mean
2540709|NCT03042910|Secondary|Time-matched Mean Change From Baseline in PR Interval|PR interval is the time between the beginning of the P wave and the start of the QRS interval, corresponding to the end of atrial depolarization and onset of ventricular depolarization.|Baseline (Day -1 time matched for each time point); 1, 2, 4 and 6 hours post-dose on Day 1; pre-dose on Day 2; pre-dose, 1, 2, 4 and 6 hours post-dose on Day 22|Electrocardiographic analysis population: all enrolled participants who received at least 1 dose of talazoparib, and had at least 1 available baseline and 1 on-treatment electrocardiogram (ECG) data.|||msec||90% Confidence Interval|Mean
2540710|NCT03042910|Secondary|Time-matched Mean Change From Baseline in Heart Rate||Baseline (Day -1 time matched for each time point); 1, 2, 4 and 6 hours post-dose on Day 1; pre-dose on Day 2; pre-dose, 1, 2, 4 and 6 hours post-dose on Day 22|Electrocardiographic analysis population: all enrolled participants who received at least 1 dose of talazoparib, and had at least 1 available baseline and 1 on-treatment electrocardiogram (ECG) data.|||beats per minute (bpm)||90% Confidence Interval|Mean
2540711|NCT03042910|Secondary|Time-matched Mean Change From Baseline in Corrected QT Intervals Based on the Bazett's Correction Fomulation (QTcB)|QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole.|Baseline (Day -1 time matched for each time point); 1, 2, 4 and 6 hours post-dose on Day 1; pre-dose on Day 2; pre-dose, 1, 2, 4 and 6 hours post-dose on Day 22|Electrocardiographic analysis population: all enrolled participants who received at least 1 dose of talazoparib, and had at least 1 available baseline and 1 on-treatment electrocardiogram (ECG) data.|||msec||90% Confidence Interval|Mean
2540712|NCT03042910|Primary|Concentration Slope of Predicted Linear Mixed Effects Models for Change From Baseline in QTcF Versus Plasma Talazoparib Concentrations at Day 22|A linear mixed effects modeling approach was used to examine the relationship between the change from baseline in QTcF and the plasma concentration of talazoparib. The model included plasma concentration, time (categorical), and treatment with random participant effects on plasma concentration and the intercept. Equation used for modeling was: Y_lkt= μ_l+ p_t+ θ × C_lkt+ W_k+ D_k × C_kt+ ε_lkt, where the dependent variable Y_lkt was for the l (treatment), k (participants) and t (time point). Parameter were: μ_l was the treatment specific intercept, θ was the slope, C was the concentration, W_k was the random patient effect on the intercept, D_k was the random patient effect on the slope, p_t was the time effect on the intercept and ε_lkt was the residual error.|Baseline (Day -1) to Day 22|Pharmacokinetic-Pharmacodynamic analysis population: participants who received at least 1 dose of talazoparib, had at least 1 available baseline and 1 on-treatment ECG data, had at least 1 time-matched pair of plasma concentration and ECG measurement obtained at the same nominal time point and met the additional requirements for PK-PD analysis.|||msec/nanogram/milliliter (msec/ng/mL)||95% Confidence Interval|Number
2540731|NCT03042559|Secondary|Hip Internal Rotation ROM|To measure the internal rotation of hip in sitting natural position with hip and knee on 90 degree flexion|Immediately following 1st session||||degree||Standard Deviation|Mean
2540732|NCT03042559|Secondary|Hip Internal Rotation ROM|To measure the internal rotation of hip in sitting natural position with hip and knee on 90 degree flexion|baseline||||degree||Standard Deviation|Mean
2540713|NCT03042910|Primary|Intercept of Predicted Linear Mixed Effects Models for Change From Baseline in QTcF Versus Plasma Talazoparib Concentrations at Day 22|A linear mixed effects modeling approach was used to examine the relationship between the change from baseline in QTcF and the plasma concentration of talazoparib. The model included plasma concentration, time (categorical), and treatment with random participant effects on plasma concentration and the intercept. Equation used for modeling was: Y_lkt= μ_l+ p_t+ θ × C_lkt + W_k + D_k × C_kt + ε_lkt, where the dependent variable Y_lkt was for the l (treatment), k (participants) and t (time point). Parameter were: μ_l was the treatment specific intercept, θ was the slope, C was the concentration, W_k was the random patient effect on the intercept, D_k was the random patient effect on the slope, p_t was the time effect on the intercept and ε_lkt was the residual error.|Baseline (Day -1) to Day 22|Pharmacokinetic-Pharmacodynamic analysis population: participants who received at least 1 dose of talazoparib, had at least 1 available baseline and 1 on-treatment ECG data, had at least 1 time-matched pair of plasma concentration and ECG measurement obtained at the same nominal time point and met the additional requirements for PK-PD analysis.|||msec||95% Confidence Interval|Number
2540714|NCT03042910|Primary|Time-matched Mean Change From Baseline in Corrected QT Intervals Based on the Fridericia's Correction Fomulation (QTcF)|QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole.|Baseline (Day -1 time matched for each time point); 1, 2, 4 and 6 hours post-dose on Day 1; pre-dose on Day 2; pre-dose, 1, 2, 4 and 6 hours post-dose on Day 22|Electrocardiographic analysis population: all enrolled participants who received at least 1 dose of talazoparib, and had at least 1 available baseline and 1 on-treatment electrocardiogram (ECG) data.|||millisecond (msec)||90% Confidence Interval|Mean
2540715|NCT03042780|Other Pre-specified|Treatment Related Morbidity|Safety analysis will be analyzed by collecting date on treatment-related morbidity and mortality. Investigators will collect data on frequency, type and severity of all adverse events that occur on or after Cycle 1, Day 1 according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE; Version 4.0).|Up to 36 months|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2540716|NCT03042780|Secondary|Progression Free Survival (PFS)|PFS: from initiation date of therapy to disease progression or death. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum).|Up to 36 months|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2540717|NCT03042780|Primary|Objective Radiographic Response Rate (ORR)|The primary efficacy endpoint is objective response rate as determined by radiology review, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response (CR): complete disappearance of all target lesions. Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). Stable Disease (SD): neither sufficient decrease to qualify for partial response nor sufficient increase to qualify for progressive disease.|Up to 36 months|Due to low accrual, study was halted prematurely. No data, as no patients were analyzed.||||||
2540718|NCT03042715|Primary|Pilot Qualitative Refinement of the Caregiver Intervention|qualitative data to develop and refine the caregiver intervention|1 year||||Participants|||Count of Participants
2540719|NCT03042702|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUCt) on Days 1 and 5|Measurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.|Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hour||||hours*ng/mL|||Number
2540720|NCT03042702|Secondary|Time to Reach the Maximum Plasma Concentration of Kevetrin (Tmax) on Days 1 and 5|Measurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.|Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hour||||hours|||Number
2540721|NCT03042702|Secondary|Maximum Plasma Concentration of Kevetrin (Cmax) on Days 1 and 5|Measurement of Kevetrin systemic concentrations from collected blood samples. Due to low number of subjects individual values are presented.|Prior to dosing, During 3h infusion: 60(±5) min, 120(±5) min, and 2 min prior to end of infusion, i.e., 178 min. Post infusion: 0.5 hour (±5 min), 1 hour (±5 min), 2 hour (±5 min), 4 hour (±10 mins), 6 hour (±30 mins) [optional], and 24(±4) hour||||ng/mL|||Number
2540722|NCT03042702|Secondary|Number of Participants by RECIST Tumor Response Category|"Number of subjects in each response category (complete response, partial response, stable disease or progressive disease) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.~CR (Complete Response): Disappearance of all target lesions PR (Partial Response) : At least a 30% decrease in the sum of the longest diameters of target lesions PD (Progressive Disease) : At least a 20% increase in the sum of the longest diameters of target lesions SD (Stable Disease) : Small changes that do not meet above criteria"|3 Weeks||||Participants|||Count of Participants
2540723|NCT03042702|Primary|Number of Participants With Changes in Biomarkers|Changes in RNA and/or protein level of pre-specified biomarkers associated with the p53 signalling pathway and apoptosis will be compared between pre-treatment sample (tumor biopsy, ascites fluid, and peripheral blood) and post-treatment sample (tumor biopsy, ascites fluid, and peripheral blood)|3 Weeks|All|||Participants|||Count of Participants
2540724|NCT03042702|Primary|Number of Participants With Treatment-Emergent Adverse Events|Reporting of Adverse Events, and severity of adverse events|6 Weeks||||Participants|||Count of Participants
2540725|NCT03042559|Secondary|Hip External Rotation ROM|To measure the external rotation of hip in sitting natural position with hip and knee on 90 degree flexion|4 weeks||||degree||Standard Deviation|Mean
2540726|NCT03042559|Secondary|Hip External Rotation ROM|To measure the external rotation of hip in sitting natural position with hip and knee on 90 degree flexion|2 weeks||||degree||Standard Deviation|Mean
2540727|NCT03042559|Secondary|Hip External Rotation ROM|To measure the External rotation of hip in sitting natural position with hip and knee on 90 degree flexion|Immediately following 1st session||||degree||Standard Deviation|Mean
2540737|NCT03042559|Primary|Lateral Step-Down Test|Lateral step test: is a quick and simple practical clinical measure of functional. Subjects with PFPS will be asked to step up and down on a 15-cm step for 15 seconds each with a cadence of 2 steps per second. The total number of step-ups during this time will be recorded. This test will be performed every two weeks to document any improvement in the functional performance. The test has shown to be reliable and valid, with test-retest reliability of (ICC = 0.90) (Ross et al, 1997).|4 weeks||||steps||Standard Deviation|Mean
2540738|NCT03042559|Primary|Lateral Step-Down Test|Lateral step test: is a quick and simple practical clinical measure of functional. Subjects with PFPS will be asked to step up and down on a 15-cm step for 15 seconds each with a cadence of 2 steps per second. The total number of step-ups during this time will be recorded. This test will be performed every two weeks to document any improvement in the functional performance. The test has shown to be reliable and valid, with test-retest reliability of (ICC = 0.90) (Ross et al, 1997).|2 weeks||||steps||Standard Deviation|Mean
2540739|NCT03042559|Primary|Lateral Step-Down Test|Lateral step test: is a quick and simple practical clinical measure of functional. Subjects with PFPS will be asked to step up and down on a 15-cm step for 15 seconds each with a cadence of 2 steps per second. The total number of step-ups during this time will be recorded. Subjects will be asked to report a verbal pain score during the step-up test at each test session. This test will be performed every two weeks to document any improvement in the functional performance. The test has shown to be reliable and valid, with test-retest reliability of (ICC = 0.90) (Ross et al, 1997).|Immediately following 1st session||||steps||Standard Deviation|Mean
2540740|NCT03042559|Primary|Lateral Step-Down Test|Lateral step test: is a quick and simple practical clinical measure of functional. Subjects with PFPS will be asked to step up and down on a 15-cm step for 15 seconds each with a cadence of 2 steps per second. The total number of step-ups during this time will be recorded. Subjects will be asked to report a verbal pain score during the step-up test at each test session. This test will be performed every two weeks to document any improvement in the functional performance. The test has shown to be reliable and valid, with test-retest reliability of (ICC = 0.90) (Ross et al, 1997).|baseline||||steps||Standard Deviation|Mean
2540741|NCT03042559|Primary|Kujala Score|A self-report questionnaire, which is used to evaluate subjective symptoms and functional limitations in subjects with PFPS with a score range between of 0 - 100 based on pain associated with variety of functional activities such as prolonged sitting, squatting, running, and jumping. A score close to 100 indicates a higher functional performance. Kujala scale has shown acceptable test-retest reliability (rho = 0.86) (Paxon et al, 2003). Kujala scale scores will be documented at the beginning and end of the intervention program.|4 weeks||||points||Standard Deviation|Mean
2540742|NCT03042559|Primary|Kujala Score|A self-report questionnaire, which is used to evaluate subjective symptoms and functional limitations in subjects with PFPS with a score range between of 0 - 100 based on pain associated with variety of functional activities such as prolonged sitting, squatting, running, and jumping. A score close to 100 indicates a higher functional performance. A score close to 0 represents a low level of function. Kujala scale has shown acceptable test-retest reliability (rho = 0.86) (Paxon et al, 2003). Kujala scale scores will be documented at the beginning and end of the intervention program.|baseline||||points||Standard Deviation|Mean
2540743|NCT03042559|Primary|Global Rating of Change (GROC)|GRC scales offer a flexible, quick, and simple method of charting self-assessed clinical progress in research and clinical settings. It ranges from -7 to 7, in which item -7 represent very great deal worse, 0 represent no change in progress, and 7 exemplify a very great better.|4 weeks||||units on a scale||Standard Deviation|Mean
2540744|NCT03042559|Primary|Global Rating of Change (GROC)|GRC scales offer a flexible, quick, and simple method of charting self-assessed clinical progress in research and clinical settings. It ranges from -7 to 7, in which item -7 represent very great deal worse, 0 represent no change in progress, and 7 exemplify a very great better.|2 weeks||||units on a scale||Standard Deviation|Mean
2540745|NCT03042559|Primary|Global Rating of Change (GROC)|GROC scales offer a flexible, quick, and simple method of charting self-assessed clinical progress in research and clinical settings. 15-Point: Scale -7 to 0 to +7. A score of 0 = No change, +1 to +3 = small positive change, +4 to +5 = Moderate positive change, +6 to +7 = Large positive change. All negative scores (minus numbers) represent a poor outcome (-7 being the worst possible outcome).|Immediately following 1st session||||units on a scale||Standard Deviation|Mean
2540746|NCT03042559|Primary|Numeric Pain Rating Scale (NPRS)|Used to assess pain level throughout the intervention. Scale: 0-10. Scoring: 0 (no pain) to 10 (worst, imaginable pain).|4 weeks||||cm||Standard Deviation|Mean
2540747|NCT03042559|Primary|Numeric Pain Rating Scale (NPRS)|The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).|2 weeks||||cm||Standard Deviation|Mean
2540748|NCT03042559|Primary|Numeric Pain Rating Scale (NPRS)|Used to assess pain level throughout the intervention. Scale: 0-10. Scoring: 0 (no pain) to 10 (worst, imaginable pain).|Immediately following 1st session||||cm||Standard Deviation|Mean
2540749|NCT03042559|Primary|Numeric Pain Rating Scale (NPRS)|The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).|baseline||||cm||Standard Deviation|Mean
2540750|NCT03042559|Primary|Anterior Pelvic Tilt|Anterior Pelvic Tilt: tilting of the pelvic will be measured with CHEK inclinometer. Tilting will be measured while subjects are in a standing position. The examiner will determine the two measure line marks, anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS) to find the oblique angle of the pelvic. Approximate normally anterior pelvic tilt for male is 9° and for female is about 12° (Nguyen, 2007). The caliper has two arms; one arm will be placed on ASIP while the other on the PSIS. The angle of the caliper will be determined to record the degree of anterior pelvic tilt.|4 weeks||||degree||Standard Deviation|Mean
2540787|NCT03041467|Secondary|Access Circuit Primary Patency|Defined as freedom from re-intervention in the access circuit or access circuit thrombosis through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-procedure. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.|3, 6, 9, 12, 18, and 24 Months|There is no planned test for 3 Month endpoint, therefore no p value at 3 Months.|||% Access Circuit Primary Patency|||Number
2540751|NCT03042559|Primary|Anterior Pelvic Tilt|Anterior Pelvic Tilt: tilting of the pelvic will be measured with CHEK inclinometer. Tilting will be measured while subjects are in a standing position. The examiner will determine the two measure line marks, anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS) to find the oblique angle of the pelvic. Approximate normally anterior pelvic tilt for male is 9° and for female is about 12° (Nguyen, 2007). The caliper has two arms; one arm will be placed on ASIP while the other on the PSIS. The angle of the caliper will be determined to record the degree of anterior pelvic tilt.|2 weeks||||degree||Standard Deviation|Mean
2540752|NCT03042559|Primary|Anterior Pelvic Tilt|"Anterior Pelvic Tilt: tilting of the pelvic will be measured with CHEK inclinometer. Tilting will be measured while subjects are in a standing position. The examiner will determine the two measure line marks, anterior superior iliac spine (ASIS) and posterior superior iliac spine (PSIS) to find the oblique angle of the pelvic.~Normative values from other study that we will be using to compare anterior pelvic tilt: Male = 9° and Female = 12° (from Nguyen study in 2007).~The CHEK inclinometer caliper has two arms; one arm will be placed on ASIS (front of pelvis) while the other on the PSIS (back of pelvis). The angle of the caliper will be determined to record the degree of anterior pelvic tilt.~Baseline measurement to Post-intervention measurement = Four (4) weeks."|Baseline to Post intervention||||degree||Standard Deviation|Mean
2540753|NCT03042299|Secondary|Number of Participants With TEAEs Related to Clinical Laboratory Tests||Baseline up to Day 6 of Intervention Period 2 (Day 18)|The safety analysis set included all the participants who received the study drug.|||Participants|||Count of Participants
2540754|NCT03042299|Secondary|Number of Participants With TEAEs Related to Electrocardiograms (ECGs)||Baseline up to Day 6 of Intervention Period 2 (Day 18)|The safety analysis set included all the participants who received the study drug.|||Participants|||Count of Participants
2540755|NCT03042299|Secondary|Number of Participants With TEAEs Related to Body Weight||Baseline up to Day 6 of Intervention Period 2 (Day 18)|The safety analysis set included all the participants who received the study drug.|||Participants|||Count of Participants
2540756|NCT03042299|Secondary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to Day 6 of Intervention Period 2 (Day 18)|The safety analysis set included all the participants who received the study drug.|||Participants|||Count of Participants
2540757|NCT03042299|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with this treatment or study participation. An AE can therefore be any unfavorable and unintended sign (for example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the study participation, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to Day 6 of Intervention Period 2 (Day 18)|The safety analysis set included all participants who received the study drug.|||Participants|||Count of Participants
2540758|NCT03042299|Secondary|Terminal Disposition Phase Rate Constant (λz) for TAK-536||Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)|The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.|||liter per hour (L/h)||Standard Deviation|Mean
2540759|NCT03042299|Secondary|MRT∞,ev: Mean Residence Time After Extravascular Administration From Time 0 to Infinity for TAK-536||Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)|The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.|||hours||Standard Deviation|Mean
2540760|NCT03042299|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536||Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)|The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.|||hours||Standard Deviation|Mean
2540761|NCT03042299|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536||Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)|The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.|||h*ng/mL||Standard Deviation|Mean
2540762|NCT03042299|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-536||Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)|The PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2540763|NCT03042299|Primary|AUC(0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for TAK-536||Day 1 pre-dose and at multiple time points post-dose (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, and 48 hours post-dose; up to 48 hours)|The pharmacokinetic (PK) analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for PK.|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
2540764|NCT03041909|Secondary|To Characterize the Effect of GBT440 on Hemolysis.|Data presented for unconjugated bilirubin at specific time point.|2 - 6 months||||umol/L|||Number
2540765|NCT03041909|Secondary|To Observed Pharmacokinetics in Plasma and Whole Blood.|Measure maximum plasma concentration (Cmax)|2 - 6 months||||ug/mL|||Number
2540766|NCT03041909|Secondary|To Assess the Efficacy of GBT440 as Measured by Improvements in Anemia|Data presented are hemoglobin value collected at specific time points.|2 - 6 months||||g/dL|||Number
2540767|NCT03041909|Primary|Number of Participants With Treatment-Emergent Adverse Events During Dosing of GBT440 for up to 6 Months.|The safety evaluation will include physical examinations, blood pressure, clinical laboratory tests (hematology, serum biochemistry) and adverse events.|2 - 6 months|Safety|||Participants|||Count of Participants
2540768|NCT03041792|Secondary|Change From Baseline in Area Under the Plasma Concentration-Time Profile of Acetaminophen for 0-60 Minutes and 0-300 Minutes (AUC0-60min and AUC0-300min) After Acetaminophen Dose at Visits 4 and 5|A non investigational medicinal product (acetaminophen 1.5 gram [g]) was administered as a challenge agent for the assessment of gastric emptying. The blood sampling for determining acetaminophen concentrations was performed at 7 time points: prior to breakfast and at 30, 60, 90, 120, 180 and 300 minutes after intake of the acetaminophen with breakfast. Baseline was calculated at Visit 3 (Study Day -1).|Prior to breakfast and at 30,60,90,120,180 and 300 minutes after intake of the acetaminophen with breakfast on Visit 3,Visit 4 (Study Day 20) and Visit 5 (Study Day 41)|Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to AUC0-60min and AUC0-300min at specified visits.|||microgram*minute/milliliter (ug*min/mL)||Standard Deviation|Mean
2540769|NCT03041792|Secondary|Change From Baseline in Satiety, Fullness, Prospective Food Consumption and Hunger Scores (Mean Rating AUC30-120min) for Mean Lunch at Visits 4 and 5|"Satiety, fullness, hunger, and prospective consumption were measured at the study site using a validated VAS questionnaire. The VAS measurement of the subcomponent scores were the same as that of the appetite score. Baseline of Mean Rating AUC30-120min was defined as the rating for mean lunch at Visit 3 (Study Day -1 and 0).The VAS was an assessment in which subjects place a vertical line across a validated 100 millimeter (mm) line to rank their response to various questions. The line was anchored by responses such as Not At All Full and Totally Full at either end. Scoring consisted of measuring the distance in mm of the vertical line from the response at the left end. The scores (total and subscale) ranged from 0 to 100. The lower values represent the better outcomes.The overall appetite score was calculated as the average of the 4 individual scores [satiety+fullness+(100−prospective food consumption)+(100−hunger)] divided by 4."|Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)|Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to VAS scores at specified visits.|||units on a scale||Standard Deviation|Mean
2540770|NCT03041792|Secondary|Change From Baseline in Appetite Score (Mean Rating Area Under Curve From Time 30 to 120 Minutes [AUC30-120min]) for Mean Lunch at Visits 4 and 5|"Appetite, satiety, fullness, hunger, and prospective consumption were measured using a validated Visual Analog scale (VAS) questionnaire. VAS was an assessment in which participants place a vertical line across a validated 100 millimeter (mm) line with the example of Not At All Full and Totally Full at either end, scoring from 0 to 100. The overall appetite score was calculated as the average of the four individual scores [satiety + fullness + (100 − prospective food consumption)+(100 − hunger)] divided by 4. The VAS questionnaire was completed by the participant immediately prior to meal administration, and at 30, 60 and 120 minutes after start of the specified meals. Baseline of Mean Rating AUC30-120min was defined as the rating for mean lunch at Visit 3 (Study Day -1 and 0)."|Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)|Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to appetite score at specified visits.|||units on a scale||Standard Deviation|Mean
2540771|NCT03041792|Secondary|Change From Baseline in Mean 48-hour Energy Intake at Visits 4 and 5|Energy intake was measured over a period of 48 hours to assess day to day variability in food intake. Observed food intake was measured as the total number of calories consumed during the specified time period, calculated as the difference of the total number of calories provided minus the total number of calories remaining after meals. Baseline was defined as the 48 hour period at Visit 3 (Study Day -1 and 0).|Visit 3, Visit 4 (Study Day 20 and 21) and Visit 5 (Study Day 41 and 42)|Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to mean 48-hour energy intake at specified visits.|||kcal||Standard Deviation|Mean
2540772|NCT03041792|Secondary|Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)|Below parameters were evaluated:1), Hematology: hemoglobin (HGB), hematocrit, erythrocytes (absolute value/mean corpuscular volume/mean corpuscular HGB/mean corpuscular HGB concentration), platelets, leukocytes, lymphocytes, neutrophils, basophils, monocytes; 2), clinical chemistry: bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, amylase, triacylglycerol lipase; 3), urinalysis: pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, bacteria.|Baseline (Visit 3) up to Visit 6 (Study Day 53)|All participants who received at least one dose of study medication classified according to the actual study treatment received.|||Participants|||Count of Participants
2540773|NCT03041792|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)|ECG categorical summarization criteria: 1) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): absolute value greater than or equal to (>=) 300 msec, percent change >=25% if baseline was greater than (>) 200 msec, and >=50% if baseline was less than or equal to (<=) 200 msec; 2) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): absolute value >=200 msec, percent change >=25% if baseline was 100 msec, and >=50% if baseline was <=100 msec; 3) QTcF interval (QT corrected for heart rate using Fridericia's formula): absolute value >450 to <=480 msec, >480 to <=500 msec, >500 msec, an increase from baseline >30 to <=60 msec or >60 msec. Baseline was defined as pre-treatment measurement on Day -2.|Baseline (Visit 3) up to Visit 6 (Study Day 53)|All participants who received at least one dose of study medication classified according to the actual study treatment received. Follow-up readings have been excluded from presentation, and 4 participants have been excluded from presentation because they only have follow up readings in post-dose phase.|||Participants|||Count of Participants
2540774|NCT03041792|Secondary|Number of Participants With Treatment-Emergent Adverse Events (All-Causality)|Adverse event (AE) was defined as any untoward medical occurrence in a study participant administered a product or medical device, regardless of its causal relationship with study treatment. An AE is considered treatment-emergent relative to a given treatment if: the event occurs for the first time during the effective duration of treatment and was not seen prior to the start of treatment (for example, during the baseline or run-in period); or the event was seen prior to the start of treatment but increased in severity during treatment.|Baseline (Visit 3) up to 31 days post last dose (75 days)|The safety analysis population included all participants who received at least one dose of study medication classified according to the actual study treatment received.|||Participants|||Count of Participants
2540775|NCT03041792|Secondary|Number of Participants With Vital Signs Data Meeting Categorical Criteria|Absolute values and changes from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse rate (PR) were recorded in supine position. Vital signs categorical summarization criteria were 1), blood pressure: SBP greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, SBP less than (<) 90 mm Hg; DBP >=20 mm Hg change from baseline, DBP <50 mm Hg; 2), PR <40 or greater than (>) 120 beats per minute (bpm). Baseline was defined as pre-treatment measurement on Day 1.|Baseline (Visit 3) up to Visit 6 (Study Day 53)|All participants who received at least 1 dose of study medication classified according to the actual study treatment received. Follow-up readings have been excluded from presentation, and 4 participants have been excluded from presentation because they only have follow up readings in post-dose phase.|||Participants|||Count of Participants
2540776|NCT03041792|Primary|Change From Baseline (Visit 3) in Mean Energy Intake During Ad Libitum Lunches at Visits 4 and 5|The mean energy intake was collected to assess the effect of liraglutide on food intake in non-diabetic, obese participants. Observed food intake was measured as the total number of calories consumed during the specified time period, calculated as the difference of the total number of calories provided minus the total number of calories remaining after meals. Mean energy intakes at Visit 4 was defined as the mean values of the measurements at Study Day 20 and 21. Same definition applies to Visit 5 (Study Day 41 and 42). Baseline was defined as the mean of Visit 3 (Study Day -1 and 0).|Visit 3, Visit 4 and Visit 5|Number of participants analyzed includes participants who met the criteria: completed baseline assessment of food intake;received at least 1 dose of randomized, blinded IP;completed at least 1 post baseline measurement(after taking randomized IP).Number analyzed includes participants contributing to mean energy intake at specified visits.|||kilocalories (kcal)||Standard Deviation|Mean
2540777|NCT03041467|Secondary|Procedure Related Adverse Event Rate|Procedure Related Adverse Event Rate: defined as proportion of subjects with procedure related Adverse Events reported post-index procedure until the first successful dialysis session. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.|30 Days, 3, 6, 9, 12, 18, and 24 Months|Number of Subjects with One or More Procedure-Related Adverse Events|||Participants|||Count of Participants
2540778|NCT03041467|Secondary|Rate of Device Related Adverse Events|Device Related Adverse Event Rate: defined as proportion of subjects with device related Adverse Events. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.|30 days, 3, 6, 9, 12, 18, and 24 Months.|Number of Subjects with One or More Device-Related Adverse Events|||Participants|||Count of Participants
2540779|NCT03041467|Secondary|Clinical Success|Resumption of successful dialysis for at least one session after index procedure.|From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure.||||Participants|||Count of Participants
2540780|NCT03041467|Secondary|Procedure Success|Maintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).|Time of Procedure||||Participants|||Count of Participants
2540781|NCT03041467|Secondary|Device Success|Device Success is defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device without burst at or below rated burst pressure (RBP) during the index procedure.|Time of Procedure||||Devices successfully used|Devices used||Number
2540782|NCT03041467|Secondary|Cumulative Access Circuit Thromboses|Proportion of subjects with access circuit thrombosis. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.|3, 6, 9, 12, 18, and 24 Months|Subjects withdrawn or lost-to-follow-up are included in the analyses up to the time consent was withdrawn, or they were exited, whichever is earlier.|||Participants|||Count of Participants
2540783|NCT03041467|Secondary|Total Number of Interventions Required to Maintain Access Circuit Patency|The number of re-interventions in the target lesion and/or access circuit. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.|3, 6, 9, 12, 18, and 24 Months||||Total number of interventons|||Number
2540784|NCT03041467|Secondary|Total Number of Interventions Required to Maintain Target Lesion Patency|The number of target lesion revascularizations per treatment arm through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-procedure. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.|3, 6, 9, 12, 18, and 24 Months||||Total number of interventions|||Number
2540785|NCT03041467|Secondary|Cumulative Target Lesion Revascularizations|The proportion of subjects with target lesion revascularizations. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.|3, 6, 9, 12, 18, and 24 Months|Subjects are included in the analyses up to the time consent was withdrawn, or they were exited, whichever is earlier.|||Participants|||Count of Participants
2540786|NCT03041467|Secondary|Target Lesion Primary Patency|Percent of subjects with freedom from clinical drive target lesion revascularization or access thrombosis occurring in the target lesion. Timepoints after 6 months are still being collected and analyzed - results will be reported when collection and analysis is completed.|3, 9, 12, 18, and 24 Months||||% of Target Lesion Primary Patency|||Number
2540788|NCT03041467|Primary|Primary Safety Endpoint - Serious Adverse Event Rate|Serious Adverse Event (SAE) rate involving the AV access circuit|30 days post procedure|All subjects with events or subjects without events but had at least 23 days of clinical follow-up were counted as evaluable subjects.|||Participants|||Count of Participants
2540789|NCT03041467|Primary|Number of Participants With Target Lesion Primary Patency Though 6 Months|Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.|6 Months Post-Procedure|Evaluable subjects were all subjects with events or subjects without events but had at least 150 days of clinical follow-up were counted as evaluable subjects. If a subject had no event and abandoned AV Access circuit within 150 days the subject will be considered not evaluable for 6-months effectiveness endpoints.|||Participants|||Count of Participants
2540790|NCT03041298|Primary|Frequency of Adverse Drug Reactions|The frequency of adverse drug reactions (serious and non-serious) that occurred following injection of Dotarem was recorded. Adverse drug reactions are adverse events related to the product administered.|From the beginning of the MR mammography procedure to 30-60 min after||||Adverse drug reactions|||Number
2540791|NCT03041298|Primary|Cytology Test Results (Percentage of Patients Per Cytology Test Result)|Diagnoses were made according to the cytology test results. Percentage of patients per cytology test result was calculated. Multiple diagnoses were possible for the same patient.|During MRI procedure|A cytology test was performed in 232 patients.|||Participants|||Count of Participants
2540792|NCT03041298|Primary|Diagnostic Results (Percentage of Patients Per Diagnosis)|Diagnoses were made with MR images. Percentage of patients per diagnosis was calculated. Multiple diagnoses were possible for the same patient.|During MRI procedure|Diagnosis was achieved in 1523 patients but results were missing for 4 patients.|||Participants|||Count of Participants
2540793|NCT03041298|Primary|Ability to Make a Diagnosis|"Ability to make a diagnosis was evaluated by answering yes or no to the question Did the examination permit a diagnosis ?"|During MRI procedure|Ability to make a diagnosis was missing for 2 patients.|||Participants|||Count of Participants
2540794|NCT03041298|Primary|Image Quality|"Image quality was evaluated on a 5-point scale: excellent; good; moderate; poor and very poor."|During MRI procedure|Image quality was missing for 16 patients.|||Participants|||Count of Participants
2540795|NCT03041181|Secondary|Number of Participants With Grade 3 or Grade 4 Adverse Events|Assess toxicity of Nivolumab plus single agent chemotherapy compared with single agent chemotherapy alone. Number of grade 3 and 4 toxicities as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.|6 months||||participants|||Number
2540796|NCT03041181|Secondary|Progression Free Survival (PFS), as Defined by irRECIST|Compare PFS rates for subjects on each treatment arm, per irRECIST. From date of randomization until the criteria for disease progression is met or death as a result of any cause, assessed up to 24 months|24 months|Data for this objective was neither collected or analyzed due to the early termination of the study.||||||
2540797|NCT03041181|Secondary|Clinical Benefit Rate (CBR) for Subjects on Each Treatment Arm, as Defined by RECIST 1.1 and irRECIST|Proportion of subjects on each arm with complete response, partial response or stable disease for at least 3 months, per RECIST 1.1 and irRECIST|From D1 of treatment until documented disease progression/recurrence, assessed for up to 24 months|Data for this objective was neither collected or analyzed due to the early termination of the study.||||||
2540798|NCT03041181|Secondary|Overall Response Rate (ORR) for Subjects on Each Treatment Arm, as Defined by RECIST 1.1 and Immune-related Response Criteria (irRECIST)|Proportion of subjects on each arm with complete response or partial response, per RECIST 1.1 and irRECIST|Every 6 weeks beginning with C3D1 and every odd numbered cycle thereafter, assessed for up to 24 months|Data for this objective was neither collected or analyzed due to the early termination of the study.||||||
2540799|NCT03041181|Primary|Progression Free Survival (PFS), as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.|Compare PFS rates for subjects on each treatment arm, per RECIST 1.1. Subjects who have not progressed will be right-censored at the date of the last follow up.|24 months|Data for this objective was neither collected or analyzed due to the early termination of the study.||||||
2540800|NCT03041090|Secondary|Percentage of Participants With Infiltrations Identified by Physicians and Sensor Device|The percentage of participants with infiltrations identified by physicians compared with those identified by the Lucerno sensor device as a measure of agreement between the two methods.|The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.||||percentage of participants|||Number
2540801|NCT03041090|Secondary|Number of Participants With Lucerno Sensor Device Detected Presence and/or Absence of Intravenous Infiltration|Review collected Lucerno sensor graphical data. The Lucerno time activity curves will capture an amount of activity from the sensors and assess subjects for presence or absence of infiltration at injection site.|The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.|The Time Activity Curve was studied that was provided from the sensor device among patients who underwent dynamic and static imaging.|||Participants|||Count of Participants
2540802|NCT03041090|Primary|Number of Participants With Intraveneous Infiltration of FDG During Routine PET/CT Imaging by Visually Assessment of Interpreting Physicians|Infiltrations of 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) during Positron Emission Tomography (PET) radiotracer administration can lead to sub-optimal images. We aim to compare rates of radiotracer presence near the injection site detected by physicians. Every subject that participates in an FDG-PET scan received an intervenous injection as part of this study. The number of participants by arm were provided in Static Imaging Participants and Dynamic Imaging Participants.|The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.||||Participants|||Count of Participants
2540803|NCT03040687|Primary|Efficacy of B7A and CS6- Hyperimmune Bovine Serum Immunoglobin to Protect Against Moderate to Severe Diarrhea After Challenge With the CS6 Expressing ETEC Strain B7A|Comparison of the number and percentage of volunteers in the arms receiving the B7A- and CS6 BSIgG vs the arm receiving the nonhyperimmune BSIgG who develop moderate to severe diarrhea.|28 days||||Participants|||Count of Participants
2540804|NCT03040687|Primary|Safety of Serum Derived Bovine Immunoglobulins (BSIgG)|Number of Participants with adverse events in groups receiving B7A- and CS6- hyperimmune (BSIgG) compared with the group receiving the nonhyperimmune product.|28 days||||Participants|||Count of Participants
2540838|NCT03040011|Secondary|POD 2 Ibuprofen Consumption|The total amount of ibuprofen medication used on postoperative day 2.|Postoperative day 2||||milligrams||Inter-Quartile Range|Median
2540805|NCT03040479|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Safety assessed from time of consent through end of study (up to 35 days). A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the Adverse Events module of this record.|Up To 35 days|All enrolled participants who received at least one dose of the study drug.|||Participants|||Count of Participants
2540806|NCT03040479|Primary|Pharmacokinetics: Terminal Elimination Half-life (T1/2)|Terminal elimination half-life, calculated as ln(2)/λZ.|Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose|All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data.|||hours (hr)||Full Range|Geometric Mean
2540807|NCT03040479|Primary|Pharmacokinetics: Apparent Elimination Rate Constant (λZ)|Apparent elimination rate constant, estimated by linear regression of the terminal linear portion of the log concentration versus time curve.|Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose|All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data.|||1/hour (1/h)||Geometric Coefficient of Variation|Geometric Mean
2540808|NCT03040479|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf])|Area under the plasma concentration time curve extrapolated to infinity, calculated as AUC(0-tlast) + CLQC/λZ, where CLQC is the measured concentration at time TLQC Apparent elimination rate constant and λz is the estimated by linear regression of the terminal linear portion of the log concentration versus time curve.|Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose|All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2540809|NCT03040479|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast])|Cumulative area under the plasma concentration time curve calculated from 0 to TLQC using the linear trapezoidal method, where TLQC represents time of last observed quantifiable plasma concentration.|Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose|All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2540810|NCT03040479|Primary|Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax)|Time of maximum observed plasma concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value.|Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose|All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data.|||hours (hr)||Full Range|Median
2540811|NCT03040479|Primary|Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)|Maximum observed plasma concentration.|Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose|All enrolled participants who received at least one dose of the study drug and had evaluable lasmiditan PK data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2540812|NCT03040362|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Safety assessed from time of consent through end of study (up to 49 days). A summary of all reported serious adverse events (SAE) and other adverse events regardless of causality are provided in the Adverse Events module of this record.|Up to 49 days|All enrolled participants who received at least one dose of the study drug and had at least 1 post-dose safety assessment.|||Participants|||Count of Participants
2540813|NCT03040362|Secondary|Renal Clearance (CLR)|Renal clearance is the volume of plasma completely cleared of lasmiditan by the kidneys per unit time and calculated as CLR = Aeu/AUC0-x (where Aeu = amount of lasmiditan excreted in urine over a sampling interval; x is the last interval collected; for lasmiditan only).|Pre-dose (-12 to 0 hours) and intervals: 0 to 6, 6 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, and 168 to 192 hours post-dose|All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.|||liter per hour (L/hr)||Standard Deviation|Mean
2540814|NCT03040362|Secondary|Percentage of Lasmiditan Recovered in Urine, Relative to Dose Administered|Percentage of lasmiditan recovered in urine (%UR), relative to dose administered calculated as %UR = 100 (amount of lasmiditan excreted in urine over a sampling interval (Aeu)/dose).|Pre-dose (-12 to 0 hours) and intervals: 0 to 6, 6 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, and 168 to 192 hours post-dose|All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.|||% of lasmiditan dose||Standard Deviation|Mean
2540815|NCT03040362|Secondary|Pharmacokinetics - Cumulative Amount of Lasmiditan and Its Metabolites Excreted in Urine|Amount of Lasmiditan and its metabolites (M3, M7, M8, (S,R)-M18, and (S,S)-M18) excreted in urine (Aeu) over sampling interval.|Pre-dose (-12 to 0 hours) and intervals: 0 to 6, 6 to 12, 12 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, and 168 to 192 hours post-dose|All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.|||milligram (mg)||Standard Deviation|Mean
2540816|NCT03040362|Primary|AUC Time Zero to Infinity (AUC0-∞) Plasma Lasmiditan/Total Radioactivity Ratio|AUC time zero to infinity (0-∞) of lasmiditan in plasma/AUC0-∞ of total radioactivity in plasma.|Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours pos-tdose|All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2540817|NCT03040362|Primary|AUC Time Zero to Infinity (AUC0-∞) Blood/Plasma Ratio|AUC time zero to infinity (0-∞) of total radioactivity in blood/AUC0-∞ of total radioactivity in plasma.|Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours post-dose|All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2540818|NCT03040362|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast])|Area under concentration time curve (AUC) from Hour 0 to the last measurable concentration based on plasma concentrations of lasmiditan.|Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours post-dose|All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2540819|NCT03040362|Primary|Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax)|Time to maximum concentration based on plasma concentrations of lasmiditan.|Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours pos-tdose|All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.|||hours (hr)||Full Range|Median
2540820|NCT03040362|Primary|Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)|Maximum observed concentration based on plasma concentrations of lasmiditan.|Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, and 192 hours post-dose|All enrolled participants who received at least one dose of the study drug and had evaluable [14C]-lasmiditan PK data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2540821|NCT03040336|Other Pre-specified|Quality of Surgical Care|AHRQ Surgical Care Survey (SCS). Scores on this scale range from 1 to 3. Lower scores indicate better communication.|Day of Surgery and 30-days postoperatively|All participants that completed the assessment were analyzed at each completed timepoint.|||score on a scale||Standard Deviation|Mean
2540822|NCT03040336|Other Pre-specified|Health Related Quality of Life|Assessment of Quality of Life (AQoL-6D). Utility score ranges from 0 to 1. Higher scores indicate better quality of life.|Baseline, day of surgery, 90-days postoperatively|Not all participants were analyzed, because this measure requires participants to complete the questionnaire and not all participants did.|||score on a scale||Standard Deviation|Mean
2540823|NCT03040336|Other Pre-specified|Postoperative Mortality|Postoperative mortality|30 and 90 days postoperatively|The mortality questionnaire was completed for all participants still enrolled in the study at the indicated time point.|||Participants|||Count of Participants
2540824|NCT03040336|Secondary|7-point Subjective Global Assessment of Nutrition_questionnaire|This standardized survey instrument is completed by a trained clinician after assessing a nutrition-specific patient history. The minimum score is 1 and the maximum score is 7. High scores indicate better nourishment.|Baseline, day of surgery, 90 days postoperatively|All participants that completed the Subjective Global Assessment were analyzed at each completed timepoint.|||score on a scale||Standard Deviation|Mean
2540825|NCT03040336|Secondary|Risk Analysis Index of Frailty (RAI)_questionnaire|This recently published frailty index is assessed by a clinician administered questionnaire. The score and reflects frailty-associated mortality risk ranging from 0-81. Higher scores indicate higher risk for post operative complications and other frailty-related outcomes.|Baseline, day of surgery, 90 days postoperatively|All participants that completed the RAI assessment were analyzed at each completed timepoint.|||score on a scale||Standard Deviation|Mean
2540826|NCT03040336|Secondary|Short Physical Performance Battery (SPPB)|This standardized outcome measure asks patients to complete several activities that are scored independently and then aggregated into an overall score ranging from 0-12. Higher scores indicate better physical performance.|Baseline, day of surgery, 90 days postoperatively|All participants that completed the SPPB assessments were analyzed at each completed timepoint.|||score on a scale||Standard Deviation|Mean
2540827|NCT03040336|Secondary|Gait Speed|Gait speed will be measured by using a stopwatch to time how long the patient takes to walk 4 meters.|Baseline, day of surgery, 90 days postoperatively|All participants that completed the gait speed assessment were analyzed at each completed timepoint.|||m/s||Standard Deviation|Mean
2540828|NCT03040336|Secondary|Serum Prealbumin|Nutrition will be measured by serum prealbumin. Higher scores indicate greater levels of protein. Lower levels indicate the potential of inflammation.|Baseline, day of surgery, 90 days postoperatively|All participants that completed the blood draw were analyzed at each completed timepoint. Additionally, there was an error in the lab when processing the blood samples, this caused many samples to be evaluated incorrectly. Only correctly analyzed labs were included in this analysis.|||mg/dL||Standard Deviation|Mean
2540829|NCT03040336|Secondary|Pulmonary Function|Pulmonary function will be measured in terms of maximal inspiratory and expiratory pressures.|Baseline, day of surgery, 90 days postoperatively|All participants that completed the pulmonary function assessments were analyzed at each completed timepoint.|||cm of water||Standard Deviation|Mean
2540830|NCT03040336|Secondary|Grip Strength|Grip strength will be measured in kilograms of pressure using a Jamar grip dynamometer|Baseline, day of surgery, 90 days postoperatively|All participants that completed the hand grip assessment were analyzed at each completed timepoint.|||kgf/cm2||Standard Deviation|Mean
2540831|NCT03040336|Primary|Compliance Rate|Compliance rates will be expressed as the percentage of total compliance with assigned pehab activities actually completed by patients as recorded in home exercise and nutrition logs and completion of on site exercise sessions.|Baseline to Day of Surgery|The compliance rate is only calculated for the prehabilitation arm.|||percentage of completed activities||Standard Deviation|Mean
2540832|NCT03040336|Primary|Retention Rate|Retention rate will be expressed as the percentage of enrolled patients who were retained in the study and completed study procedures. It will be calculated for incremental steps along the study timeline and at the completion of study procedures 90 days postoperatively.|Baseline to 90 days postoperatively||||Participants|||Count of Participants
2540833|NCT03040336|Primary|Randomization Rate|Randomization rate will be expressed as the percentage of eligible patients who agreed to participate who then agreed to be randomized to control or intervention conditions|Baseline|17 participants were overall analyzed. 10 were randomized to prehab, 7 were randomized to standard of care.|||Participants|||Count of Participants
2540834|NCT03040336|Primary|Recruitment Rate|Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.|Baseline|54 is the number of patients approached. Only 17 were consented and overall analyzed.|||Participants|||Count of Participants
2540835|NCT03040323|Secondary|Success Rate|Biopsy sample being sufficient for histological diagnosis and/or complete genotyping.|30 days|Insufficient patient recruitment and following internal IRB audit study was abandoned/terminated. No data were collected for Outcome Measures||||||
2540836|NCT03040323|Primary|Complication Rate|Complication will be defined as 1) bleeding seen on post-biopsy CT or US, 2) drop in hemoglobin of more than 1.5 g/dL within one week after biopsy, or 3) need for hepatic artery embolization.|30 days|Insufficient patient recruitment and following internal IRB audit study was abandoned/terminated. No data were collected for Outcome Measures||||||
2540837|NCT03040011|Secondary|POD 3 Ibuprofen Consumption|The total amount of ibuprofen medication used on postoperative day 3.|Postoperative day 3||||milligrams||Inter-Quartile Range|Median
2540843|NCT03040011|Secondary|Return to Baseline Activities Using the Activities Assessment Scale|"Resumed normal daily activities using the Activities Assessment Scale (AAS) by 12 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from No difficulty to Not able to do it. A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.~We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint."|12 weeks postoperative||||Participants|||Count of Participants
2540844|NCT03040011|Secondary|Return to Baseline Activities Using the Activities Assessment Scale|"Resumed normal daily activities using the Activities Assessment Scale (AAS) by 6 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from No difficulty to Not able to do it. A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.~We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint."|6 weeks postoperative||||Participants|||Count of Participants
2540845|NCT03040011|Secondary|Return to Baseline Activities Using the Activities Assessment Scale|"Resumed normal daily activities using the Activities Assessment Scale (AAS) by 2 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from No difficulty to Not able to do it. A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.~We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint."|2 week postoperative||||Participants|||Count of Participants
2540846|NCT03040011|Secondary|Return to Baseline Activities Using the Activities Assessment Scale|"Resumed normal daily activities using the Activities Assessment Scale (AAS) by 1 week after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from No difficulty to Not able to do it. A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.~We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint."|1 week postoperative||||Participants|||Count of Participants
2540847|NCT03040011|Secondary|Anti-emetic Consumption|The amount of inpatient anti-emetic consumption, recorded in number of doses of nausea medication|3 hours postoperatively|This data was not collected. Rather, we assessed the PONV score which is described in outcome number 9.||||||
2540848|NCT03040011|Secondary|Nausea and Vomiting Measured by the PONV Scale|Intensity of postoperative nausea and vomiting (PONV) measured by the PONV scale prior to discharge. The Postoperative Nausea and Vomiting Intensity Scale is a four-question assessment to measure clinically significant nausea and vomiting with a range from 0-7 with higher scores signifying more clinically significant nausea and vomiting.|6 hours postoperatively||||score on a scale||Inter-Quartile Range|Median
2540849|NCT03040011|Secondary|Adverse Events|The number of adverse events in each study group was assessed and compared between study groups. An adverse event was described as any medical or surgical complication that occurred either intraoperatively or postoperatively.|0-12 weeks postoperatively||||number of adverse events|||Number
2540850|NCT03040011|Secondary|Postoperative Urinary Retention|Urinary retention was defined as the need to perform self-catheterization or have an indwelling catheter placed postoperatively. The proportion of patients with urinary retention was compared between groups.|0-24 hours postoperatively||||Participants|||Count of Participants
2540851|NCT03040011|Secondary|Proportion of Patients With Same Day Discharge|Same day discharge was defined as a patient being discharged on the same day as surgery and did not require an admission after surgery. The proportion of patients who were discharged on the day of surgery was compared between groups.|Day of surgery||||Participants|||Count of Participants
2540852|NCT03040011|Secondary|1 Week Postoperative Pain Measured by the NRS|Postoperative Pain Measured by the Numeric Rating Scale 1 week after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.|1 week after surgery||||score on a scale||Inter-Quartile Range|Median
2540853|NCT03040011|Secondary|POD 3 Postoperative Pain Measured by the NRS|Postoperative Pain Measured by the NRS 3 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.|3 days after surgery||||score on a scale||Inter-Quartile Range|Median
2540854|NCT03040011|Secondary|POD 2 Postoperative Pain Measured by the NRS|Postoperative Pain Measured by the NRS 2 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.|2 days after surgery||||score on a scale||Inter-Quartile Range|Median
2540855|NCT03040011|Secondary|6 Hour Postoperative Pain Measured by the NRS|"Postoperative pain as measured by the NRS at 6 hours after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.~Of note, there is a typographical error in the protocol section and refers to this outcome as a NRS score at 3 hours postoperatively. The final IRB approved protocol is a 6 hour postoperative timepoint and this is the correct outcome reported here in the results section."|6 hours postoperatively||||score on a scale||Inter-Quartile Range|Median
2540856|NCT03040011|Primary|Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS)|Postoperative pain measured by the numerical rating scale (NRS) at 24 hours postoperatively. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.|24 hours postoperatively||||score on a scale||Inter-Quartile Range|Median
2540873|NCT03039621|Primary|Time to Alleviation of All ARVI Symptoms.|Based on patient diary data. Criteria of alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom).|14 days of observation.|ITT sample|||days||95% Confidence Interval|Mean
2540874|NCT03039569|Secondary|Degree of Concern of CVD Event in Lifetime|Self-report survey question on Cardiovascular disease (CVD) awareness: degree of concern of CVD event in lifetime|Three months|Chi-square|||Participants|||Count of Participants
2540857|NCT03039738|Secondary|Clinicians Familiarity With AHA Guidelines and Telemetry Utilization as Measured by Qualitative Questionnaires|"Number of clinicians very familiar and somewhat familiar with AHA guidelines was reported. The questionnaire was administered to all clinicians (e.g. ED physicians, nurses, critical care nurses, intensivists, and hospitalists) involved in the care of study participants at each hospital; it was not administered to study subjects."|Baseline to end of hospital stay (or up to 30 days post enrollment)|All clinicians (e.g. ED physicians, nurses, critical care nurses) involved in the care of study participants at each hospital (not study subjects.) The study was prematurely terminated; no conclusion should be drawn from the reported data. The data for SM Arm were not collected, and no outcome measure analyses were performed.|||Participants|||Count of Participants
2540858|NCT03039738|Secondary|Clinical Team and Patient Satisfaction as Measured by Qualitative Questionnaires|Clinical Team and Patient Satisfaction will be determined by comparing the Qualitative Questionnaire response between monitoring arms.|Baseline to end of hospital stay (or up to 30 days post enrollment)|The patient and clinical team satisfaction questionnaires were designed to be collected for the SM arm only. The study enrolled control arm only prior to termination. The questionnaires were not collected, and no outcome measure analyses were performed.||||||
2540859|NCT03039738|Secondary|Time of Rapid Response Team Activation to Time of a Threshold Notification as Measured by the Surveillance Monitoring System Only|Time of Rapid Response Team (RRT) will be determined by comparing the number of RRT interventions between monitoring arms (only for surveillance monitoring arm)|Baseline to end of hospital stay (or up to 30 days post enrollment)|The study was prematurely terminated; this outcome was for Surveillance Monitoring arm only. The data were not collected, and no outcome measure analysis was performed.||||||
2540860|NCT03039738|Secondary|Number of Participants With Clinical Interventions (CI) as Determined by Review of Medical Records|CI include Rapid Response Team calls and Code Blue Activations. The Number of Clinical Interventions will be determined by comparing numbers between monitoring arms.|Baseline to end of hospital stay (or up to 30 days post enrollment)|The study was prematurely terminated; the data for SM Arm were not collected, and no outcome measure analyses were performed. No conclusion should be drawn from the reported data.|||Participants|||Count of Participants
2540861|NCT03039738|Secondary|Length of Stay (LOS) in the ICU as Determined by Review of Medical Records|Length of Stay in the ICU will be determined by comparing numbers between monitoring arms.|Baseline to end of hospital stay (or up to 30 days post enrollment)|The study was prematurely terminated; the data for SM Arm were not collected, and no outcome measure analyses were performed. No conclusion should be drawn from the reported data. Only participants who were admitted to ICU, were assessed for this Outcome.|||hrs||Standard Deviation|Mean
2540862|NCT03039738|Secondary|Number of Participants With Hospital Unit Transfers (HUT) as Determined by Review of Medical Records|Hospital Unit Transfers (HUT) will be determined by comparing the number of hospital unit transfers between monitoring arms.|Baseline to end of hospital stay (or up to 30 days post enrollment)|The study was prematurely terminated; the data for SM Arm were not collected, and no outcome measure analyses were performed. No conclusion should be drawn from the reported data.|||Participants|||Count of Participants
2540863|NCT03039738|Secondary|Associated Health Care Costs (HCC) as Determined by Review of Billing Records|Health Care Costs will be determined by comparing HCC between the surveillance monitoring and telemetry monitoring arms|Baseline to end of hospital stay (or up to 30 days post enrollment)|The study was prematurely terminated; the billing data for both TM and SM arms were not collected, and outcome measure analysis was not performed.||||||
2540864|NCT03039738|Primary|Hospital Length of Stay (LOS) as Assessed by Review of Medical Records|LOS will be determined by comparing LOS Between the Surveillance Monitoring and Telemetry Monitoring Period Arms.|Baseline to end of hospital stay (or up to 30 day post enrollment)|The study was prematurely terminated; no conclusion should be drawn from the reported data. Data for SM arm were not collected.|||hrs||Standard Deviation|Mean
2540865|NCT03039621|Secondary|Percentage of Patients With Worsening of Illness.|Based on patient diary data. The disease worsening: ARVI complications, including those requiring antibiotics; hospitalization).|14 days of observation peiod.|ITT sample|||Participants|||Count of Participants
2540866|NCT03039621|Secondary|Rates of Antipyretics Use Per Patient.|Based on patient diary data. The number of intakes of prescribed antipyretics.|On days 1- 5 of the treatment period.|ITT sample|||number per patient||95% Confidence Interval|Mean
2540867|NCT03039621|Secondary|Percentage of Recovered Patients.|Based on patient diary data. Criteria of recovery/alleviation of all ARVI symptoms: oral temperature ≤37.5С for 24 hours (without subsequent increase within the observation period) + absence of ARVI symptoms /presence of ARVI symptoms with ≤3-point of the total score (TS) according to the 4-point scale for each flu-like nonspecific and respiratory symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom, for each flu-like nonspecific and respiratory symptom).|On days 2-6 of the observation period.|ITT sample|||Participants|||Count of Participants
2540868|NCT03039621|Secondary|ARVI Severity.|Based on the area under the curve of TS for days 2-6, according to the patient diary. The total score (TS) will be calculated based on the severity of each ARVI symptom (sum of 11 symptoms = body temperature, flu-like nonspecific symptoms (4 symptoms) and respiratory symptoms (6 symptoms) according to the 4-point scale (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). To calculate TS the absolute oral temperature values, measured in degrees Celsius, will be converted into relative units (or points), given the following gradations: ≤37.5С = 0 point; 37.6-38.1C = 1 point; 38.2-38.8C = 2 points; ≥38.90С = 3 points. For total score minimum and maximum scores are 0 and 33, where higher values represent worse outcome.|On days 2-6 of the observation period.|ITT sample|||score on a scale*day||95% Confidence Interval|Mean
2540869|NCT03039621|Secondary|Flu-like Nonspecific and Respiratory Symptoms Total Score (TS) for Days 2-6.|Based on patient diary data. The total score (TS) ranges from 0 to 30 consisting of 4 flu-like nonspecific (decreased activity/weakness, poor appetite/refusal to eat, sick appearance, sleep disturbance) and 6 respiratory (runny nose, stuffy nose/nasal congestion, sneezing, hoarseness, sore throat, cough) symptoms according to the 4-point scale for each symptom (0 = no symptom; 1 = mild symptom; 2 = moderate symptom; 3 = severe symptom). The higher values represent a worse outcome.|On days 2-6 of the observation period.|ITT sample|||score on a scale||95% Confidence Interval|Mean
2540876|NCT03039569|Secondary|Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity|A Self-report physical activity measure over the past month. The activities were converted to metabolic equivalent (MET: a measure of exercise intensity based on oxygen consumption) minutes per week for moderate/vigorous physical activity|Three months|Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.|||MET minutes/week||Standard Error|Least Squares Mean
2540877|NCT03039569|Secondary|Total Carbohydrate|A self-report food frequency questionnaire over the past month|One month|Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.|||gram/day||Standard Error|Least Squares Mean
2540878|NCT03039569|Secondary|Frequency of Concern of CVD Event|Self-report question to measure a patient's cardiovascular disease awareness: Frequency of concern of CVD event|Three months|Chi-square|||Participants|||Count of Participants
2540879|NCT03039569|Secondary|Self-report Hemoglobin A1C|Self-report hemoglobin for diabetes status|Three months|Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.|||percentage of glycated HB in blood||Standard Error|Least Squares Mean
2540880|NCT03039569|Primary|Eat >= 5 Servings Fruit and Vegetables|Self report survey question (days/week)|Three months|Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.|||day/week (min: 0 days; max 7 days)||Standard Error|Least Squares Mean
2540881|NCT03039569|Primary|Self-care Activity: Foot Care|Average of four self-report survey questions of the category (days over the last seven days)|three months|Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.|||day/week (min: 0 days; max 7 days)||Standard Error|Least Squares Mean
2540882|NCT03039569|Primary|Self-care Activity: Medication Adherence|Self-report survey question (days over the last seven days)|three months|Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.|||day/week (min: 0 days; max 7 days)||Standard Error|Least Squares Mean
2540883|NCT03039569|Primary|Self-care Activity: Blood Glucose Testing|Average of two self-report survey question items related to blood glucose testing in the category (days over the last seven days)|three months|Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.|||days/ week (min: 0 days; max: 7 days))||Standard Error|Least Squares Mean
2540884|NCT03039569|Primary|Diabetes Self-care Activity: Exercise|Average of two self-report survey questions related to exercise in the category (days/over the last 7 days)|Three months|Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.|||days/week (min: 0 days; Max: 7 days)||Standard Error|Least Squares Mean
2540885|NCT03039569|Primary|Self-Care Activities: Healthy Eating|An average of summary scores of the four self-report heathy eating related items in the category (days/over the last 7 days)|Three months|Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.|||days/week (min: 0 days; Max: 7 days)||Standard Error|Least Squares Mean
2540886|NCT03039543|Secondary|Other Postoperative Adverse Events|Pain, postoperative nausea and vomiting, dry mouth, Postoperative bladder discomfort|During PACU stay (An average of 15 minutes)|One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)|||Participants|||Count of Participants
2540887|NCT03039543|Secondary|the Incidence of Desaturation|Respiratory complication such as desaturation (SpO2 < 90%) were recorded during PACU stay.|During PACU stay (An average of 15 minutes)|One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)|||Participants|||Count of Participants
2540888|NCT03039543|Secondary|Recovery Time (PACU Discharge)|time needed to reach a modified Aldrete score of 9|During PACU stay (An average of 15 minutes)|One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)|||minutes||Standard Deviation|Mean
2540889|NCT03039543|Secondary|Incidence of Postoperative Residual Curarization|the number of participant with Postoperative residual curarization (PORC, TOF ratio < 0.9 )|at the arrival of postoperative post-anesthesia care unit (PACU), an average of 5 minutes|One patient in the moderate NMB group and 3 patients in the deep NMB group were excluded from the final analysis (1 in deep NMB group: unexpected co-operation; 1 in moderate NMB group and 2 in deep NMB group: did not maintain moderate or deep NMB)|||Participants|||Count of Participants
2540898|NCT03039179|Primary|Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores)|Numbers of Participants With Heel Pressure Sores of all grade Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.: Grade 1: Non-blanchable erythema of intact skin. Discoloration of the skin, warmth, oedema, induration or hardness may also be used as indicators, particularly in individuals with darker skin. Grade 2: Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion or blister. Grade 3: Full thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia. Grade 4: Extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss.|every day until discharge (expected average of 3 days)||||Participants|||Count of Participants
2540890|NCT03039543|Primary|Number of Participants Attaining a 5 (Optimal) Surgical Condition Score|"5-point surgical condition scale was evaluated as follows.~Extremely poor~unable to work because of coughing or because of the inability to obtain a endoscopic view because of inadequate muscle relaxation. Additional neuromuscular blocking agents (NMB) must be given.~Poor~severely hampered by inadequate muscle relaxation with continuous muscle contractions, movements, or both with the hazard of tissue damage. Additional NMB is needed.~Acceptable~a wide endoscopic view but bladder contractions, movements, or both occur regularly causing some interference with the surgeon's work. There is the need for additional NMB to prevent deterioration.~Good~a wide endoscopic working field with sporadic muscle contractions, movements, or both. No immediate need for additional NMB unless there is the fear of deterioration.~Optimal~a wide endoscopic working field without any movement or contractions. No additional NMB is needed."|immediately following the operation, an average of 5 minutes||||Participants|||Count of Participants
2540891|NCT03039283|Primary|Percentage of Participants Showing Post-operative Improvement in Best Aided Condition in Noise.|Is tested using the centre's clinical routine speech. Participants are listening in their normal hearing configuration: often with acoustic hearing aids in both ears preoperatively, an implant in one ear and hearing aid in the opposite, or using two implants, one in each ear postoperatively. Centres used different types of speech in noise testing. Lists of sentences were presented in competing background noise. In some cases the noise level was fixed at 10 dB signal-to-noise ratio, and the percentage of words correctly repeated was recorded (over two lists). Alternatively, an adaptive procedure is used such that after each sentence is presented the speech level is decreased if >50% of the words are correctly repeated in the sentence, or increased if otherwise. The test result is the mean signal-to-noise ratio of the last eight presentations. An average of two lists is used as the result representing the signal-to-noise ratio that gives 50% sentence understanding.|Pre-operatively and at 6 months post-operatively|4 of the 159 participants had pre-operative and 6-month post-operative data available in the best aided condition to compare.|||Percentage of participants||95% Confidence Interval|Number
2540892|NCT03039283|Primary|Percentage of Participants Showing Post-operative Improvement in the Ipsilateral Ear in Noise.|Is tested using the centre's clinical routine speech. Participants are listening using only the ear which was treated using hearing aid preoperatively and the implant postoperatively. Centres used different types of speech in noise testing. Lists of sentences were presented in competing background noise. In some cases the noise level was fixed at 10 dB signal-to-noise ratio, and the percentage of words correctly repeated was recorded (over two lists). Alternatively, an adaptive procedure is used such that after each sentence is presented the speech level is decreased if >50% of the words are correctly repeated in the sentence, or increased if otherwise. The test result is the mean signal-to-noise ratio of the last eight presentations. An average of two lists is used as the result representing the signal-to-noise ratio that gives 50% sentence understanding.|Pre-operatively and at 6 months post-operatively|36 of the 159 participants had pre-operative and 6-month post-operative data available in the ipsilateral condition to compare.|||Percentage of participants||95% Confidence Interval|Number
2540893|NCT03039283|Primary|Percentage of Participants Showing Post-operative Improvement in Best Aided Condition in Quiet|Is tested using the centre's clinical routine speech. Participants are listening in their normal hearing configuration: often with acoustic hearing aids in both ears preoperatively, an implant in one ear and hearing aid in the opposite, or using two implants, one in each ear postoperatively. All centres used Freiburger German monosyllable lists. Recorded lists of everyday words are presented to participants at 65 dB SPL (loud conversational speech level) from loudspeakers and participants repeat back what they hear. Lists are scored as a percentage correct words, with two lists being used per condition to represent speech understanding in quiet.|Pre-operatively and at 6 months post-operatively|60 of the 159 participants had pre-operative and 6-month post-operative data available in the best aided condition to compare.|||Percentage of participants||95% Confidence Interval|Number
2540894|NCT03039283|Primary|Percentage of Participants Showing Post-operative Improvement in the Ipsilateral Ear in Quiet.|Is tested using the centre's clinical routine speech. Participants are listening using only the ear which was treated using hearing aid preoperatively and the implant postoperatively. All centres used Freiburger German monosyllable lists. Recorded lists of everyday words are presented to participants at 65 dB SPL (loud conversational speech level) from loudspeakers and participants repeat back what they hear. Lists are scored as a percentage correct words, with two lists being used per condition to represent speech understanding in quiet.|pre-operatively and at 6 months post-operatively|99 of the 159 participants had pre-operative and 6-month post-operative data available in the ipsilateral condition to compare.|||Percentage of participants||95% Confidence Interval|Number
2540895|NCT03039283|Primary|Change From Pre-operative (Daily Listening Condition) Baseline Speech Understanding in Noise at 6 Months Post-operative (Best Aided Conditions).|Is tested using the centre's clinical routine speech tests. Participants are listening in their normal hearing configuration: often with acoustic hearing aids in both ears preoperatively, an implant in one ear and hearing aid in the opposite, or using two implants, one in each ear postoperatively. Centres used different types of speech in noise testing. Lists of sentences were presented in competing background noise. An adaptive procedure is used such that after each sentence is presented the speech level is decreased if >50% of the words are correctly repeated in the sentence, or increased if otherwise. The test result is the mean signal-to-noise ratio of the last eight presentations. An average of two lists is used as the result representing the signal-to-noise ratio that gives 50% sentence understanding.|pre-operatively and at 6 months post-operatively|15 participants with routine speech understanding data in noise available at pre-op and at 6 months were analyzed.|||Speech Recognition Threshold in decibels||Standard Deviation|Mean
2540896|NCT03039283|Primary|Change From Pre-operative (Daily Listening Condition) Baseline Speech Understanding in Quiet at 6 Months Post-operative (Best Aided Conditions).|Is tested using the centre's clinical routine speech tests. Participants are listening in their normal hearing configuration: often with acoustic hearing aids in both ears preoperatively, an implant in one ear and hearing aid in the opposite, or using two implants, one in each ear postoperatively. All centres used Freiburger German monosyllable lists. Recorded lists of everyday words are presented to participants at 65 dB SPL (loud conversational speech level) from loudspeakers and participants repeat back what they hear. Lists are scored as a percentage correct words, with two lists being used per condition to represent speech understanding in quiet.|pre-operatively and at 6 months post-operatively|49 participants with routine speech understanding data available at pre-op and 6 months were analysed.|||Percent correct||Standard Deviation|Mean
2540902|NCT03039088|Primary|To Evaluate the Presence of Fibromyalgia (Defined by a FIRST Questionnaire >= 5/6) as a Predisposing Factor for Lower Treatment Response Rates to TNF Alpha Blockers|The difference in BASDAI50 response at week 12 between the patients with and those without fibromyalgia.|At 12 weeks after TNF alpha blockers initiation||||participants|||Number
2540903|NCT03038867|Secondary|Follicle Stimulating Hormone Level at 10 Weeks|Follicle stimulating hormone level (mIU/mL) at 10 weeks|10 Weeks|23 patients in the Duloxetine group and 6 patients in the Placebo group did not have FSH measured at 10 weeks (patients were not available).|||mIU/mL||Standard Deviation|Mean
2540904|NCT03038867|Secondary|Follicle Stimulating Hormone Level at 8 Weeks|Follicle stimulating hormone level (mIU/mL) at 8 weeks|8 weeks|15 patients in the Duloxetine group and 4 patients in the Placebo group did not have FSH measured at 8 weeks (patients were not available).|||mIU/mL||Standard Deviation|Mean
2540905|NCT03038867|Secondary|Follicle Stimulating Hormone Level at 6 Weeks|Follicle stimulating hormone level (mIU/mL) at 6 weeks|6 weeks|16 patients in the Duloxetine group and 2 patients in the Placebo group did not have FSH measured at 6 weeks (patients were not available).|||mIU/mL||Standard Deviation|Mean
2540906|NCT03038867|Secondary|Follicle Stimulating Hormone Level at 2 Weeks|Follicle stimulating hormone level (mIU/mL) at 2 weeks|2 weeks|9 patients in the Duloxetine group and 1 patient in the Placebo group did not have FSH measured at 2 weeks (patients were not available).|||mIU/mL||Standard Deviation|Mean
2540907|NCT03038867|Secondary|Follicle Stimulating Hormone Level at 0 Weeks|Follicle stimulating hormone level (mIU/mL) at 0 weeks|0 weeks|5 patients in the Duloxetine group and 1 patient in the Placebo group did not have FSH measured at 0 weeks (patients were not available).|||mIU/mL||Standard Deviation|Mean
2540908|NCT03038867|Secondary|Luteinizing Hormone Level at 10 Weeks|Luteinizing hormone level (mIU/mL) at 10 weeks|10 Weeks|22 patients in the Duloxetine group and 5 patients in the Placebo group did not have LH measured at 10 weeks (patients were not available).|||mIU/mL||Standard Deviation|Mean
2540909|NCT03038867|Secondary|Luteinizing Hormone Level at 8 Weeks|Luteinizing hormone level (mIU/mL) at 8 weeks|8 weeks|13 patients in the Duloxetine group and 2 patients in the Placebo group did not have LH measured at 8 weeks (patients were not available).|||mIU/mL||Standard Deviation|Mean
2540910|NCT03038867|Secondary|Luteinizing Hormone Level at 6 Weeks|Luteinizing hormone level (mIU/mL) at 6 weeks|6 weeks|11 patients in the Duloxetine group and 1 patient in the Placebo group did not have LH measured at 6 weeks (patients were not available).|||mIU/mL||Standard Deviation|Mean
2540911|NCT03038867|Secondary|Luteinizing Hormone Level at 2 Weeks|Luteinizing hormone level (mIU/mL) at 2 weeks|2 weeks|8 patients in the Duloxetine group did not have LH measured at 2 weeks (patients were not available).|||mIU/mL||Standard Deviation|Mean
2540912|NCT03038867|Secondary|Luteinizing Hormone Level at 0 Weeks|Luteinizing hormone level (mIU/mL) at 0 weeks|0 weeks|3 patients in the Duloxetine group did not have LH measured at 0 weeks (patients were not available).|||mIU/mL||Standard Deviation|Mean
2540913|NCT03038867|Secondary|Prolactin Level at 10 Weeks|Prolactin level (ng/mL) at 10 weeks|10 Weeks|20 patients in the Duloxetine group and 5 patients in the Placebo group did not have prolactin measured at 10 weeks (patients were not available).|||ng/mL||Standard Deviation|Mean
2540914|NCT03038867|Secondary|Prolactin Level at 8 Weeks|Prolactin level (ng/mL) at 8 weeks|8 weeks|12 patients in the Duloxetine group and 2 patients in the Placebo group did not have prolactin measured at 8 weeks (patients were not available).|||ng/mL||Standard Deviation|Mean
2540915|NCT03038867|Secondary|Prolactin Level at 6 Weeks|Prolactin level (ng/mL) at 6 weeks|6 weeks|11 patients in the Duloxetine group and 1 patient in the Placebo group did not have prolactin measured at 6 weeks (patients were not available).|||ng/mL||Standard Deviation|Mean
2540916|NCT03038867|Secondary|Prolactin Level at 2 Weeks|Prolactin level (ng/mL) at 2 weeks|2 weeks|8 patients in the Duloxetine group did not have prolactin measured at 2 weeks (patients were not available).|||ng/dL||Standard Deviation|Mean
2540917|NCT03038867|Secondary|Prolactin Level at 0 Weeks|Prolactin level (ng/mL) at 0 weeks|0 weeks|3 patients in the Duloxetine group did not have prolactin measured at 0 weeks (patients were not available).|||ng/mL||Standard Deviation|Mean
2540918|NCT03038867|Secondary|Estrogen Level at 10 Weeks|Estrogen level (pg/mL) at 10 weeks|10 Weeks|23 patients in the Duloxetine group and 8 patients in the Placebo group did not have estrogen measured at 10 weeks (patients were not available).|||pg/mL||Standard Deviation|Mean
2540919|NCT03038867|Secondary|Estrogen Level at 8 Weeks|Estrogen level (pg/mL) at 8 weeks|8 weeks|17 patients in the Duloxetine group and 6 patients in the Placebo group did not have testosterone measured at 8 weeks (patients were not available).|||pg/mL||Standard Deviation|Mean
2540920|NCT03038867|Secondary|Estrogen Level at 6 Weeks|Estrogen level (pg/mL) at 6 weeks|6 weeks|16 patients in the Duloxetine group and 5 patients in the Placebo group did not have estrogen measured at 6 weeks (patients were not available).|||pg/mL||Standard Deviation|Mean
2540921|NCT03038867|Secondary|Estrogen Level at 2 Weeks|Estrogen level (pg/mL) at 2 weeks|2 weeks|16 patients in the Duloxetine group did not have estrogen measured at 2 weeks (patients were not available).|||pg/mL||Standard Deviation|Mean
2540922|NCT03038867|Secondary|Estrogen Level at 0 Weeks|Estrogen level (pg/mL) at 0 weeks|0 weeks|6 patients in the Duloxetine group and 3 patients in the Placebo group did not have estrogen measured at 0 weeks (patients were not available).|||pg/mL||Standard Deviation|Mean
2540923|NCT03038867|Secondary|Testosterone Level at 10 Weeks|Testosterone level (ng/dL) at 10 weeks|10 Weeks|21 patients in the Duloxetine group and 8 patients in the Placebo group did not have testosterone measured at 10 weeks (patients were not available).|||ng/dL||Standard Deviation|Mean
2540924|NCT03038867|Secondary|Testosterone Level at 8 Weeks|Testosterone level (ng/dL) at 8 weeks|8 weeks|12 patients in the Duloxetine group and 4 patients in the Placebo group did not have testosterone measured at 8 weeks (patients were not available).|||ng/dL||Standard Deviation|Mean
2540925|NCT03038867|Secondary|Testosterone Level at 6 Weeks|Testosterone level (ng/dL) at 6 weeks|6 weeks|12 patients in the Duloxetine group and 2 patients in the Placebo group did not have testosterone measured at 6 weeks (patients were not available).|||ng/dL||Standard Deviation|Mean
2540926|NCT03038867|Secondary|Testosterone Level at 2 Weeks|Testosterone level (ng/dL) at 2 weeks|2 weeks|8 patients in the Duloxetine group did not have testosterone measured at 2 weeks (patients were not available).|||ng/dL||Standard Deviation|Mean
2540928|NCT03038867|Secondary|Sperm Tail Defects at 10 Weeks|Sperm tail defects (mean number) at 10 weeks|10 Weeks|15 patients in the Duloxetine group and 4 patients in the Placebo group did not have tail defects measured at 10 weeks (patients were not available).|||defects||Standard Deviation|Mean
2540929|NCT03038867|Secondary|Sperm Tail Defects at 8 Weeks|Sperm tail defects (mean number) at 8 weeks|8 weeks|14 patients in the Duloxetine group and 4 patients in the Placebo group did not have tail defects measured at 8 weeks (patients were not available).|||defects||Standard Deviation|Mean
2540930|NCT03038867|Secondary|Sperm Tail Defects at 6 Weeks|Sperm tail defects (mean number) at 6 weeks|6 weeks|11 patients in the Duloxetine group and 7 patients in the Placebo group did not have tail defects measured at 6 weeks (patients were not available).|||defects||Standard Deviation|Mean
2540931|NCT03038867|Secondary|Sperm Tail Defects at 2 Weeks|Sperm tail defects (mean number) at 2 weeks|2 weeks|16 patients in the Duloxetine group and 3 patients in the Placebo group did not have tail defects measured at 2 weeks (patients were not available).|||defects||Standard Deviation|Mean
2540932|NCT03038867|Secondary|Sperm Tail Defects at 0 Weeks|Sperm tail defects (mean number) at 0 weeks|0 weeks|6 patients in the Duloxetine group and 4 patients in the Placebo group did not have tail defects measured at 0 weeks (patients were not available).|||defects||Standard Deviation|Mean
2540933|NCT03038867|Secondary|Sperm Neck Defects at 10 Weeks|Sperm neck defects (mean number) at 10 weeks|10 Weeks|15 patients in the Duloxetine group and 3 patients in the Placebo group did not have neck defects measured at 10 weeks (patients were not available).|||defects||Standard Deviation|Mean
2540934|NCT03038867|Secondary|Sperm Neck Defects at 8 Weeks|Sperm neck defects (mean number) at 8 weeks|8 weeks|14 patients in the Duloxetine group and 2 patients in the Placebo group did not have neck defects measured at 8 weeks (patients were not available).|||defects||Standard Deviation|Mean
2540935|NCT03038867|Secondary|Sperm Neck Defects at 6 Weeks|Sperm neck defects (mean number) at 6 weeks|6 weeks|11 patients in the Duloxetine group and 11 patients in the Placebo group did not have neck defects measured at 6 weeks (patients were not available).|||defects||Standard Deviation|Mean
2540936|NCT03038867|Secondary|Sperm Neck Defects at 2 Weeks|Sperm neck defects (mean number) at 2 weeks|2 weeks|11 patients in the Duloxetine group and 2 patients in the Placebo group did not have neck defects measured at 2 weeks (patients were not available).|||defects||Standard Deviation|Mean
2540937|NCT03038867|Secondary|Sperm Neck Defects at 0 Weeks|Sperm neck defects (mean number) at 0 weeks|0 weeks|3 patients in the Duloxetine group did not have neck defects measured at 0 weeks (patients were not available).|||defects||Standard Deviation|Mean
2540938|NCT03038867|Secondary|Sperm Head Defects at 10 Weeks|Sperm head defects (mean number) at 10 weeks|10 Weeks|15 patients in the Duloxetine group and 3 patients in the Placebo group did not have head defects measured at 10 weeks (patients were not available).|||defects||Standard Deviation|Mean
2540939|NCT03038867|Secondary|Sperm Head Defects at 8 Weeks|Sperm head defects (mean number) at 8 weeks|8 weeks|13 patients in the Duloxetine group and 2 patients in the Placebo group did not have head defects measured at 8 weeks (patients were not available).|||defects||Standard Deviation|Mean
2540940|NCT03038867|Secondary|Sperm Head Defects at 6 Weeks|Sperm head defects (mean number) at 6 weeks|6 weeks|11 patients in the Duloxetine group and 5 patients in the Placebo group did not have head defects measured at 6 weeks (patients were not available).|||defects||Standard Deviation|Mean
2540941|NCT03038867|Secondary|Sperm Head Defects at 2 Weeks|Sperm head defects (mean number) at 2 weeks|2 weeks|11 patients in the Duloxetine group and 2 patients in the Placebo group did not have head defects measured at 2 weeks (patients were not available).|||defects||Standard Deviation|Mean
2540942|NCT03038867|Secondary|Sperm Head Defects at 0 Weeks|Sperm head defects (mean number) at 0 weeks|0 weeks|3 patients in the Duloxetine group did not have head defects measured at 0 weeks (patients were not available).|||defects||Standard Deviation|Mean
2540943|NCT03038867|Secondary|Sperm Motility at 10 Weeks|Sperm motility (mean percent) at 10 weeks|10 Weeks|15 patients in the Duloxetine group and 3 patients in the Placebo group did not have motility measured at 10 weeks (patients were not available).|||percent motility||Standard Deviation|Mean
2540944|NCT03038867|Secondary|Sperm Motility at 8 Weeks|Sperm motility (mean percent) at 8 weeks|8 weeks|13 patients in the Duloxetine group and 2 patients in the Placebo group did not have motility measured at 8 weeks (patients were not available).|||percent motility||Standard Deviation|Mean
2540945|NCT03038867|Secondary|Sperm Motility at 6 Weeks|Sperm motility (mean percent) at 6 weeks|6 weeks|11 patients in the Duloxetine group and 5 patients in the Placebo group did not have motility measured at 6 weeks (patients were not available).|||percent motility||Standard Deviation|Mean
2540946|NCT03038867|Secondary|Sperm Motility at 2 Weeks|Sperm motility (mean percent) at 2 weeks|2 weeks|11 patients in the Duloxetine group and 2 patients in the Placebo group did not have motility measured at 2 weeks (patients were not available).|||percent motility||Standard Deviation|Mean
2540947|NCT03038867|Secondary|Sperm Motility at 0 Weeks|Sperm motility (mean percent) at 0 weeks|0 weeks|3 patients in the Duloxetine group did not have motility measured at 0 weeks (patients were not available).|||percent motility||Standard Deviation|Mean
2540948|NCT03038867|Secondary|Sperm Concentration at 10 Weeks|Sperm concentration (number of sperm/mL) in semen analysis at 10 weeks|10 Weeks|16 patients in the Duloxetine group and 2 patients in the Placebo group did not have sperm concentration measured at 10 weeks (patients were not available).|||Number of sperm/mL||Standard Deviation|Mean
2540949|NCT03038867|Secondary|Sperm Concentration at 8 Weeks|Sperm concentration (number of sperm/mL) in semen analysis at 8 weeks|8 weeks|14 patients in the Duloxetine group and 2 patients in the Placebo group did not have sperm concentration measured at 8 weeks (patients were not available).|||Number of sperm/mL||Standard Deviation|Mean
2540950|NCT03038867|Secondary|Sperm Concentration at 6 Weeks|Sperm concentration (number of sperm/mL) in semen analysis at 6 weeks|6 weeks|11 patients in the Duloxetine group and 5 patients in the Placebo group did not have sperm concentration measured at 6 weeks (patients were not available).|||Number of sperm/mL||Standard Deviation|Mean
2540951|NCT03038867|Secondary|Sperm Concentration at 2 Weeks|Sperm concentration (number of sperm/mL) in semen analysis at 2 weeks|2 weeks|10 patients in the Duloxetine group and 2 patients in the Placebo group did not have sperm concentration measured at 2 weeks (patients were not available).|||Number of sperm/mL||Standard Deviation|Mean
2540952|NCT03038867|Secondary|Sperm Concentration at 0 Weeks|Sperm concentration (number of sperm/mL) in semen analysis at 0 weeks|0 weeks|3 patients in the Duloxetine group did not have sperm concentration measured at 0 weeks (patients were not available).|||Number of sperm/mL||Standard Deviation|Mean
2540953|NCT03038867|Primary|Number of Participants With Abnormal Sperm DNA Fragmentation at 10 Weeks|Number of participants with Tunel values > 25% at 10 weeks in each treatment group|10 Weeks|18 patients in the Duloxetine group and 4 patients in the Placebo group did not have Tunel data at 10 weeks (patients were not available).|||Participants|||Count of Participants
2540954|NCT03038867|Primary|Number of Participants With Abnormal Sperm DNA Fragmentation at 8 Weeks|Number of participants with Tunel values > 25% at 8 weeks in each treatment group|8 weeks|15 patients in the Duloxetine group and 4 patients in the Placebo group did not have Tunel data at 8 weeks (patients were not available).|||Participants|||Count of Participants
2540955|NCT03038867|Primary|Number of Participants With Abnormal Sperm DNA Fragmentation at 2 Weeks|Number of participants with Tunel values > 25% at 2 weeks in each treatment group|2 weeks|12 patients in the Duloxetine group and 2 patients in the Placebo group did not have Tunel data at 2 weeks (patients were not available).|||Participants|||Count of Participants
2540956|NCT03038867|Primary|Number of Participants With Abnormal Sperm DNA Fragmentation at 0 Weeks|Number of participants with Tunel Values > 25% at 0 Weeks (baseline) in each treatment group|0 weeks|5 patients in the Duloxetine group did not have Tunel data measured at 0 weeks (patients were not available)|||Participants|||Count of Participants
2540957|NCT03038867|Primary|Number of Participants With Abnormal Sperm DNA Fragmentation at 6 Weeks|Number of participants with TUNEL values > 25% at 6 weeks in each treatment group|6 Weeks (primary time point of interest)|11 patients in the Duloxetine group and 7 patients in the Placebo group did not have Tunel data measured at 6 weeks (patients were not available).|||Participants|||Count of Participants
2540958|NCT03038815|Secondary|Symmetrie Index|The symmetrie index, represents the % difference step length, index= 2*100*(step length left-step length right)/(step length left+step length right) This measure has no unit. 0 would represent a total symmetric gait.|duration of a session is typically 3 hours||||percentage of step length||Standard Deviation|Mean
2540959|NCT03038815|Primary|ROM Ankle Joint|Ankle joint motion ROM Sagittal left, during gait|duration of a session is typically 3 hours||||degree||Standard Deviation|Mean
2540960|NCT03038126|Secondary|Hospitalization|Frequency of unanticipated hospitalization events over duration of study|3 months, 6 months|number analyzed in each row differs due to various reasons including inability to complete specific measurements, missed visits, drop-out, ESRD, death, and loss to follow-up.|||hospitalizaztions per month||95% Confidence Interval|Mean
2540961|NCT03038126|Secondary|Change in Renal Function|Change in GFR from baseline to 6 months|6 months|number analyzed differs from total population due to various reasons including inability to complete specific measurements, missed visits, drop-out, ESRD, death, and loss to follow-up.|||ml/min/1.73m2||Standard Deviation|Mean
2540962|NCT03038126|Primary|Safety Events|number of safety events discovered in each study arm. In-center safety events include those detected during study visit vital signs and laboratory results (e.g. hypotension, hyperkalemia, etc.) Self-reported safety events include patient-identified incidents reported to staff at study visits (e.g. hypoglycemia, leg/ankle swelling, falls etc.)|3 months, 6 months|number analyzed in each row differs due to various reasons including inability to complete specific measurements, missed visits, drop-out, ESRD, death, and loss to follow-up.|||safety events|||Number
2540963|NCT03037905|Other Pre-specified|Analgesic Use|Number of people requiring analgesia in the post-anesthesia care unit|Postoperatively|Patients that have undergone thyroid and/or parathyroid surgery|||Participants|||Count of Participants
2540964|NCT03037905|Secondary|Difference Between Pre-operative Heart Rate and a Mean of 3 Post-operative Heart Rates|Difference between pre-operative heart rate and a mean of 3 post-operative heart rates assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit|Pre-operative to post-operative|Patients undergoing thyroid and/or parathyroid surgery|||beats per minute||95% Confidence Interval|Mean
2540965|NCT03037905|Secondary|Difference Between Pre-operative Systolic Blood Pressure and a Mean of 3 Post-operative Systolic Blood Pressures|Difference between pre-operative systolic blood pressure and a mean of 3 post-operative systolic blood pressures assessed at 15, 30 and 45 minutes after placement in post-anesthesia care unit|Pre-operative to post-operative|Patients undergoing thyroid and/or parathyroid surgery|||mm Hg||95% Confidence Interval|Mean
2540966|NCT03037905|Primary|Change (Difference) in Anxiety|"Change (difference) in anxiety level as measured by a 100 millimeter line visual analog scale from baseline (pre-operative) to arrival in post anesthesia care unit (post-operative).The anxiety visual analog scale quantifies current state of anxiety. It is measured on a 100 millimeter line with anchors No anxiety to The most anxiety I can imagine. Participants make a mark across the line to represent their current state of anxiety. A millimeter ruler is used to measure from left to right with the number of millimeters recorded where the mark crosses the line, minimum score is 0 and maximum score is 100. Higher number means more anxiety."|Pre-operatively to post-operatively|thyroid and/or parathyroid surgery patients|||units on a scale||95% Confidence Interval|Mean
2540967|NCT03037619|Secondary|Fitbit Engagement|Percentage of days Fitbit was worn|4 months|"Buddy participants (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses"|||Percentage of days||Standard Deviation|Mean
2540968|NCT03037619|Secondary|Percentage of Participants Satisfied With the Fitbit|Acceptability of the Fitbit (% satisfied with Fitbit)|4 months|"Buddy participants (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses"|||Participants|||Count of Participants
2540969|NCT03037619|Secondary|Social Support|Social Support & Exercise Survey - Family score (sum items 11 - 16 and 20 - 23); Scores can range between 10-50, with a higher score indicating more support|4 months|"Buddy participants (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses"|||score on a scale||Standard Deviation|Mean
2540970|NCT03037619|Primary|Moderate/Vigorous Intensity Physical Activity|Number of minutes/day of moderate and vigorous intensity physical activity measured by the Fitbit|4 months|"Buddy participants (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses"|||minutes/day||Standard Deviation|Mean
2540973|NCT03037489|Primary|Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients|"Number of Participants with Treatment Emergent Adverse Events (TEAEs)~Number of Participants with Serious Adverse Events (SAEs)~Number of Participants with TEAEs related to treatment~Number of Participants with mild TEAEs~Number of Participants with moderate TEAEs~Number of Participants with severe TEAEs~Number of Participants with TEAEs leading to early discontinuation"|Group A: 0-56 weeks; Group B: 0-30 weeks||||Participants|||Count of Participants
2540974|NCT03037307|Primary|Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Test Adhesive vs. Negative Control)|Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.|Up to 12 hours|Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy.|||lbs||Standard Error|Least Squares Mean
2540975|NCT03037307|Primary|Area Over Baseline Over 12 Hours (AOB0-12) for the Incisal Bite Force (Positive Control Adhesive Versus [vs.] Negative Control)|Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (pounds [lbs]). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.|Up to 12 hours|Analysis for this outcome was performed on intention-to-treat (ITT) population which included all randomized participants with at least one post baseline assessment of efficacy.|||lbs||Standard Error|Least Squares Mean
2540976|NCT03037203|Other Pre-specified|Change From Baseline in the Mean Sleep Latency Time (in Minutes) on the Maintenance of Wakefulness Test (MWT)|"Change from Baseline mean sleep latency (in minutes) on the MWT defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4).~The MWT is the standard objective measure of an individual's ability to remain awake during the daytime in a darkened, quiet environment. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicated greater ability to stay awake."|Baseline to Weeks 1, 2, 3, and 4|The MWT analysis evaluated results from subjects in the mITT population who were in Group 1 only (N=53 subjects).|||minutes||Standard Error|Least Squares Mean
2540977|NCT03037203|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score|"Change from Baseline ESS defined in terms of change from study baseline (prior to first dose in Period 1) to the end of each Treatment Period (Weeks 1, 2, 3, and 4).~The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions, asking subjects how likely they would be to doze off or fall asleep in different situations. Responses range from 0 = would never doze to 3 = high chance of dozing. Higher scores represent greater severity of excessive sleepiness. The total score ranges from 0 - 24, with higher scores representing greater severity of excessive sleepiness."|Baseline to Weeks 1, 2, 3, and 4|The modified Intent-to-Treat population is defined as all randomized subjects who took at least one dose of study drug and have a Baseline and at least one post-Baseline efficacy assessment. Two subjects who did not have at least one post-baseline efficacy data were excluded from the mITT Population, resulting in a total of 64 subjects.|||score on a scale||Standard Error|Least Squares Mean
2540978|NCT03037203|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Early Discontinuation||Up to Day 35|The Safety population includes all subjects who received at least one dose of study drug|||Participants|||Count of Participants
2540979|NCT03036852|Secondary|PK Parameter: Ctau of VEL|Ctau is defined as the population PK derived concentration of the drug at the end of a 24 hour dosing interval. The 24 hour Ctau is estimated based on the combination of sparse PK samples collected at random times across the dosing interval as well as intensive PK samples collected for up to 12 hours post-dose.|Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))|Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Ctau of VEL.|||ng/mL||Standard Deviation|Mean
2540980|NCT03036852|Secondary|PK Parameter: Cmax of VEL|Cmax is defined as the population PK derived maximum concentration of the drug.|Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))|Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of VEL.|||ng/mL||Standard Deviation|Mean
2540981|NCT03036852|Secondary|PK Parameter: Cmax of GS-331007 (Metabolite of SOF)|Cmax is defined as the population PK derived maximum concentration of the drug.|Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))|Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of GS-331007.|||ng/mL||Standard Deviation|Mean
2540982|NCT03036852|Secondary|PK Parameter: Cmax of SOF|Cmax is defined as the population PK derived maximum concentration of the drug.|Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))|Participants in the PK Analysis set with available data were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of SOF.|||ng/mL||Standard Deviation|Mean
2540983|NCT03036852|Secondary|PK Parameter: AUCtau of VEL|AUCtau is defined as the population PK derived area under the concentration verses time curve of the drug over the dosing interval.|Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))|Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of VEL.|||h*ng/mL||Standard Deviation|Mean
2540984|NCT03036852|Secondary|PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)|AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.|Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))|Participants in the PK analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of GS-331007 .|||h*ng/mL||Standard Deviation|Mean
2540985|NCT03036852|Secondary|Pharmacokinetic (PK) Parameter: AUCtau of SOF|AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.|Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))|Participants in the PK Analysis Set (all participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose concentration value for the corresponding analyte in plasma) with available data were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of SOF.|||h*ng/mL||Standard Deviation|Mean
2540986|NCT03036852|Secondary|Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment|Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants. For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was > 1000 IU/mL.|First dose date up to Posttreatment Week 24|Participants in the Resistance Analysis Population Set included all participants in the Safety Analysis Set with a virologic outcome and at least 1 gene sequenced. All data are reported at a 15% assay cutoff.|||Participants|||Count of Participants
2540987|NCT03036852|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit"|Baseline to Posttreatment Week 24|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2540988|NCT03036852|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Weeks 2, 4, 6, 8, and 12|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2540989|NCT03036852|Secondary|Change From Baseline in HCV RNA||Baseline; Weeks 2, 4, 6, 8, and 12|Participants in the Full Analysis Set with available date were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2540990|NCT03036852|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)|SVR24 was defined as HCV RNA < LLOQ 24 weeks after stopping study treatment.|Posttreatment Week 24|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2540991|NCT03036852|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ 4 weeks after stopping study treatment.|Posttreatment Week 4|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2540992|NCT03036852|Primary|Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event||First dose date up to Week 12|The Safety Analysis Set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2540993|NCT03036852|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment.|Posttreatment Week 12|The Full Analysis Set included participants who are enrolled into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2540994|NCT03036839|Secondary|PK Parameter: Cmax of GS-331007 (Metabolite of SOF)|Cmax is defined as the population PK derived maximum concentration of the drug.|Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))|Participants in the PK Analysis Set were analyzed.|||ng/mL||Standard Deviation|Mean
2540995|NCT03036839|Secondary|PK Parameter: Cmax of SOF|Cmax is defined as the population PK derived maximum concentration of the drug.|Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))|Participants in the PK Analysis Set with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2540996|NCT03036839|Secondary|PK Parameter: Cmax of LDV|Cmax is defined as the population PK derived maximum concentration of the drug.|Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))|Participants in the PK Analysis Set were analyzed.|||ng/mL||Standard Deviation|Mean
2540997|NCT03036839|Secondary|PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)|AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.|Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))|Participants in the PK Analysis Set were analyzed.|||h*ng/mL||Standard Deviation|Mean
2540998|NCT03036839|Secondary|PK Parameter: AUCtau of SOF|AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.|Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))|Participants in the PK Analysis Set with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
2553264|NCT02780622|Secondary|Oral Plasma Clearance (CL/F) for R- and S- Warfarin||Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.|||liters per hour (L/h)||Standard Deviation|Mean
2540999|NCT03036839|Secondary|Pharmacokinetics (PK) Parameter: AUCtau of LDV|AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.|Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))|The PK Analysis Set included all participants who took at least 1 dose of the study drug and had at least 1 nonmissing postdose concentration value for the corresponding analyte in plasma.|||h*ng/mL||Standard Deviation|Mean
2541000|NCT03036839|Secondary|Percentage of Participants Who Developed Resistance to LDV and SOF||Baseline up to Posttreatment Week 24|The Resistance Analysis Population was defined as all participants in the Safety Analysis Set with a virologic outcome and at least 1 gene sequenced. As no participant had a relapse in this study, this outcome could not be analyzed.||||||
2541001|NCT03036839|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline up to Posttreatment Week 24|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2541002|NCT03036839|Secondary|Change From Baseline in HCV RNA||Weeks 2, 4, 6, 8, 12, 16, 20, 24|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2541003|NCT03036839|Secondary|HCV RNA||Weeks 2, 4, 6, 8, 12, 16, 20, 24|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2541004|NCT03036839|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment|"The total number of participants with HCV RNA < LLOQ was the sum of the number of participants with HCV RNA < LLOQ detected plus the number of participants with HCV RNA < LLOQ target not detected (TND). LLOQ was 15 IU/mL. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method."|Weeks 2, 4, 6, 8, 12, 16, 20, 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2541005|NCT03036839|Secondary|Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)|SVR24 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 24 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.|Posttreatment Week 24|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2541006|NCT03036839|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 4 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.|Posttreatment Week 4|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2541007|NCT03036839|Primary|Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event||First dose date up to Week 24|The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.|||percentage of participants|||Number
2541008|NCT03036839|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. The exact 95% confidence interval (CI) for the percentage within treatment group was based on the Clopper-Pearson method.|Posttreatment Week 12|The Full Analysis Set (FAS) included participants who were enrolled into the study and received at least 1 dose of study drug. Participants were grouped within the Full Analysis Set by genotype and treatment group to which they were enrolled.|||percentage of participants||95% Confidence Interval|Number
2541009|NCT03036735|Primary|"Number of Participants With Incidence of Middle Meatal Synechiae Post Fess ( Functional Endoscopic Surgery ), as Accurate and Appropriate)."|Steroid eluting spacer will be measured by incidence of 35 and 90-day post Functional Endoscopic Sinus Surgery (FESS) incidence of middle meatal synechiae.|35 to 90days|Study was terminated , funds withdrawn. No data was collected or analyzed.||||||
2541010|NCT03036384|Secondary|Number of Satisfied Participants|Maternal satisfaction (yes or no) will be assessed 1 hour after surgery in the PACU (Post Anesthesia Care Unit)|up to 1 hour after surgery|Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95|||Participants|||Count of Participants
2541011|NCT03036384|Secondary|Number of Participants With Dizziness|All parturients will be questioned for dizziness (yes or no)|Up to 24 hours after surgery|Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95|||Participants|||Count of Participants
2541012|NCT03036384|Secondary|Number of Participants With Urinary Retention|All parturients will be questioned for urinary retention (yes or no)|Up to 24 hours after surgery|Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95|||Participants|||Count of Participants
2541013|NCT03036384|Secondary|Number of Participants With Pruritus|from 15 minutes after spinal anesthesia and every 4 hours for 24 hours (score 0=no symptoms; 1=symptoms with no treatment necessary; 2=symptoms present and treated)|Up to 24 hours after surgery|Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95|||Participants|||Count of Participants
2541014|NCT03036384|Secondary|Number of Participants With Nausea or Vomiting|from 15 minutes after spinal anesthesia and every 4 hours for 24 hours (score 0=no symptoms; 1=symptoms with no treatment necessary; 2=symptoms present and treated)|up to 24 hours after surgery|Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95|||Participants|||Count of Participants
2541015|NCT03036384|Secondary|Number of Participants With Transient Neurologic Symptoms (TNS)|TNS are defined as pain and/or dysesthesia occurred after complete release of sensory block at the gluteal level, at the thighs and at the legs. At Day 0, Day 1, Day 3 and Day 5|up to 5 Days|Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95|||Participants|||Count of Participants
2541016|NCT03036384|Secondary|Number of Participants Needing Vasopressors|"Arterial blood pressure will be measured at every 2.5 minute during surgery, then at every 20 minutes in the PACU (Post Anesthesia Care Unit). Vasopressors were given for patients with low blood pressure.~A low blood pressure is defined as a blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia)."|during surgery (average 1 hour)|Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95|||Participants|||Count of Participants
2541017|NCT03036384|Secondary|Newborn Methemoglobinemia (MetHb)|Newborn Methemoglobinemia (MetHb) will be assessed at delivery by cordal blood sample, as a routine control, and expressed as a percentage of total hemoglobinemia.|average 1 hour|Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95|||percentage of MetHb||Standard Deviation|Mean
2541018|NCT03036384|Secondary|Newborn Apgar Score|Newborn Apgar score assessed at 1, 5, 10 minutes after baby extraction. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting score ranges from zero to 10. The five criteria are summarized using words chosen to form an abbreviation (Appearance, Pulse, Grimace, Activity, Respiration).|up to 10 minutes after baby extraction|Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95|||score on a scale||Standard Deviation|Mean
2541019|NCT03036384|Secondary|Bromage Motor Block Level at End of Surgery|Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 min after spinal anaesthesia (T0) and until the end of surgery.|Until complete release of motor block (average 4 hours)|Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95|||score on a scale||Standard Deviation|Mean
2541020|NCT03036384|Secondary|Motor Block Duration|Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 minutes after spinal anaesthesia (T0) and until the end of surgery. Duration was defined from the time of the spinal injection until Bromage scale = 1.|Until complete release of motor block (Bromage scale = 1; average 4 hours)|Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95|||hours||Standard Deviation|Mean
2541021|NCT03036384|Secondary|Sensitive Block at End of Surgery|Level of Sensory block assessed as loss of sensation to cold, every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, thereafter, once 30 minutes until total regression of sensory block (T12-S1). For this study, dermatome levels are depicted on a scale ranging from 1 to 18. (1 to 12 = T1-T12 thoracic levels; 13 to 17 = L1-L5 lumbar levels; 18 = S1 sacral level)|Until complete release of sensory block (T12-S1) (average 4 hours)|Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95|||Dermatome level||Standard Deviation|Median
2541022|NCT03036384|Secondary|Sensitive Block Duration|Level of Sensory block assessed as loss of sensation to cold, every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, thereafter, once 30 minutes until total regression of sensory block (T12-S1).|Until complete release of sensory block (T12-S1) (average 4 hours)|Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95|||hours||Standard Deviation|Mean
2541023|NCT03036384|Primary|Success of Anesthesia|The nerve blockade will be considered as success when a bilateral T4 level will reach in 15 minutes after intrathecal injection without additional epidural injection needed within 45 minutes peri-operative ; no pain at the skin incision, no pain during 45 minutes after the skin incision|during surgery (average 1 hour)||||Participants|||Count of Participants
2541024|NCT03036215|Secondary|Graded Chronic Pain Interference|Assessment of graded Chronic Pain Interference - Scale (0-100); 0 = lowest pain interference 100 = highest pain interference. If findings in negative values = improvement; positive values = worsening condition.|Change from baseline to 16 weeks post intervention||||units on a scale||Standard Deviation|Mean
2541025|NCT03036215|Primary|Assessing Change in Jaw Functioning|Jaw Functional Limitation Scale (JFLS-8) identifies daily activities interfered with by jaw pain - 8 items Scale 0-80 (80 more severe)|Change from baseline to 16 weeks post intervention||||units on a scale||Standard Deviation|Mean
2541026|NCT03036215|Primary|Assessing Graded Chronic Pain Severity Evaluation Feasibility of the PACT Program|Measure: Graded Chronic Pain Scale (GCPS) with mean intensity ratings for reported current, worst, and average pain. 3 items: Scale 0-100 (100 most severe)|Change from baseline to 16 weeks post intervention||||units on a scale||Standard Deviation|Mean
2541027|NCT03036163|Secondary|AUC0-t/AUC0-∞|AUC0-t/AUC0-∞ ratio|Up to 72 hours after the last drug administration|PKA|||ratio|||Number
2541028|NCT03036163|Secondary|Area Under the Concentration-time Curve (AUC0-t)|The area under the concentration-time curve from 0 to last blood sampling|Up to 72 hours after the last drug administration|PKA|||ng*h/ml||Standard Deviation|Mean
2541029|NCT03036163|Secondary|Volume of Steady State Distribution (Vd,ss) of PBTZ169|For cohorts 6 and 7 (multiple administration) only|Up to 72 hours after the last drug administration|||||||
2541030|NCT03036163|Secondary|Area Under the Plasma Concentration Versus Time Curve in Steady State (AUCss) of PBTZ169|For cohorts 6 and 7 (multiple administration) only|Up to 72 hours after the last drug administration|||||||
2541031|NCT03036163|Secondary|Time to Reach Maximum Steady State Concentration (Tmax,ss) of PBTZ169|For cohorts 6 and 7 (multiple administration) only|Up to 72 hours after the last drug administration|||||||
2541032|NCT03036163|Secondary|Peak Steady State Plasma Concentration (Cmax,ss) of PBTZ169|For cohorts 6 and 7 (multiple administration) only|Up to 72 hours after the last drug administration|||||||
2541033|NCT03036163|Secondary|Renal Clearance (Clren) of PBTZ169|The renal clearance was calculated using values of the cumulative excretion in urine (from zero to 24 hours) and the area under the pharmacokinetic curve (from zero to 24 hours) (the ratio of the cumulative excretion to AUC0-24)|Up to 24 hours after the drug administration|PKA|||mL/h||Standard Deviation|Mean
2541034|NCT03036163|Secondary|Elimination Constant (Kel) of PBTZ169|Data for doses 320 mg (Cohorts 4 and 6, total 11 volunters) & 640 mg (Cohorts 5 and 7, total 11 volunters) were combined|Up to 72 hours after the last drug administration|PKA|||1/h||Standard Deviation|Mean
2541038|NCT03036163|Secondary|Plasma Half-life Time (T1/2) of PBTZ169|Single dosing (Cohorts 1-5): data for the dosing day (Day 1). Multiple dosing (Cohorts 6, 7): data for days 1 (1st dose), 7 and 14 (last dose)|Up to 72 hours after the last drug administration|PKA|||h||Standard Deviation|Mean
2541039|NCT03036163|Secondary|Area Under the Concentration-time Curve (AUC0-∞)|In the time interval from 0 to infinity|Up to 72 hours after the last drug administration|PKA: C1-5 - SAD, C6-7 - MAD for 14 days|||ng*h/ml||Standard Deviation|Mean
2541040|NCT03036163|Secondary|Time to Reach Maximum Concentration (Tmax) of PBTZ169|Single dosing (Cohorts 1-5): data for the dosing day (Day 1). Multiple dosing (Cohorts 6, 7): data for days 1 (1st dose), 7 and 14 (last dose)|Up to 72 hours after the last drug administration|PKA|||h||Full Range|Median
2541041|NCT03036163|Secondary|Peak Plasma Concentration (Сmax) of PBTZ169|"Up to 72 hours after the last drug administration:~Single dosing (Cohorts 1-5): up to Day 4 (72 h after the dosing (Day 1)) Multiple dosing (Cohorts 6. 7): up to Day 17 (72 h after the last (14th) dosing)"|Up to 72 hours after the last drug administration|Pharmacokinetics analysis population (PKA): C1-5: sbjs who received PBTZ169 and had at least one measurement of PBTZ169 concentration; C6-7: sbjs who received PBTZ169 at least 7 times and had measurements of PBTZ169 concentration after the first and seventh administration.|||ng/ml||Standard Deviation|Mean
2541042|NCT03036163|Primary|Incidence of Drug-related Adverse Events [Safety and Tolerability]|The frequency of adverse events for which a relationship to the test drug PBTZ169 was noted|14±1 days after the drug administration (up to last visit time point)|Safety population: subjects who received at least one dose of PBTZ169. The population was used for the analysis and evaluation of the demographic and other baseline data and all safety parameters including AEs, physical examination, evaluation of the vital signs, previous and current therapy, ECG, all laboratory tests|||participants|||Number
2541043|NCT03036072|Secondary|Adverse Events|In a population of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, is there evidence for increased frequency of severe, moderate or other adverse events in the delayed rewarming group compared to the standard of care group?|4 days||||Participants|||Count of Participants
2541044|NCT03036072|Primary|Serum Biomarkers for Brain Injury|In a population of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, does delayed rewarming administered during the 12 hours after surgery, compared to standard care, decrease brain injury as measured by levels of serum biomarkers of brain injury, s100b and neuron specific enolase during the four days after surgery?|4 days|Laboratory storage and transportation issues resulted in less than expected number of viable specimens that could be analyzed at all 5 time points.|||Participants|||Count of Participants
2541045|NCT03035955|Primary|Demodex Count|number of demodex at Baseline and Week 4. Only Week 4 reported|Week 4||||number of demodex|||Number
2541046|NCT03035942|Secondary|Pain During Postanesthesia Care Unit and Ward Stay (Numeric Rating Scale - NRS)|Pain were assessed every 15 minutes during postanesthesia care unit, where zero meant no pain and 10 the worst imaginable pain (higher values represent worse outcome). Twenty four hours after surgery, patients were asked to describe the highest pain score (NRS) during ward stay.|24 hours||||Score on a scale (NRS)||Inter-Quartile Range|Median
2541047|NCT03035942|Secondary|Number of Participants With Pruritus|The occurrence of localized or generalized itching (patients who answered yes or no)|24 hours||||Participants|||Count of Participants
2541048|NCT03035942|Secondary|Nausea and Vomiting During PACU Staying|The occurrence of PONV will be registered during the PACU|4h||||Participants|||Count of Participants
2541049|NCT03035942|Primary|Quality of Recovery|Quality of Recovery Questionnaire (QoR-40). Minimum score 40 (very poor quality of recovery) and maximun score 200 (excellent quality of recovery). Higher scores mean better outcome|Twenty four hours after surgery by a blinded investigator||||Score on a scale||Inter-Quartile Range|Median
2541050|NCT03035929|Secondary|ANP (Atrial Natriuretic Peptide)|Natriuretic peptide levels after drug administration|0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration|Analysis was not able to be completed on any of the samples because reliable assay is not available at this time.||||||
2541051|NCT03035929|Secondary|BNP (B-type Natriuretic Peptide)|Natriuretic peptide levels after drug administration|0-8 hrs, 24 hrs, 48 hrs, 72 hrs after drug administration|Analysis was not able to be completed on any of the samples because reliable assay is not available at this time.||||||
2541052|NCT03035929|Secondary|Changes in NT-proBNP|Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours|at baseline, 24 hours, 48 hours and 72 hours||||pg/ml||Standard Deviation|Mean
2541053|NCT03035929|Secondary|Changes in NT-proANP|Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours|baseline, 24 hours, 48 hours and 72 hours||||nmol/l||Standard Deviation|Mean
2541054|NCT03035929|Primary|Changes in NT-proBNP From Baseline to 8 Hours|Change in natriuretic peptide levels after drug administration|Baseline and 8 hours||||pg/ml||Standard Deviation|Mean
2541055|NCT03035929|Primary|Changes in NT-proANP From Baseline to 8 Hours|Change in natriuretic peptide levels after drug administration|baseline and 8 hours||||nmol/l||Standard Deviation|Mean
2541056|NCT03035916|Secondary|Side Effects: Number of Participants With Vomiting|The state of vomiting was evaluated after surgery during first postoperative 48 hours.|up to 48h after surgery||||participants|||Number
2541057|NCT03035916|Secondary|Side Effects: Number of Participants With Nausea|The state of nausea was evaluated after surgery during first postoperative 48 hours.|up to 48h after surgery||||participants|||Number
2541058|NCT03035916|Secondary|Side Effects: Number of Participants With Sedation|The state of sedation was evaluated after surgery during first postoperative 48 hours.|up to 48h after surgery||||participants|||Number
2541059|NCT03035916|Secondary|Anesthesia Recovery: Number of Participants With Prolonged Hospitalization|The percentage of long hospitalization were measured. More than 7 days after surgery is defined as prolonged hospitalization.|Through study completion, an average of 2 weeks||||participants|||Number
2541060|NCT03035916|Secondary|Anesthesia Recovery: the Time of First Flatus|The time of first flatus was measured after surgery.|Through study completion, an average of 2 weeks||||hour||Standard Deviation|Mean
2541252|NCT03030638|Primary|Baseline Characteristics of New Users of Olodaterol: Gender|Baseline characteristics of patients in treatment group by data source: Gender|Baseline|Study population|||Participants|||Count of Participants
2541061|NCT03035916|Secondary|Questionnaire: Pain Scores on Movement|Pain scores of the participants will be measured by the Visual Analogue Scale. Measurement of VAS: Draw a 10cm horizontal line on the paper. The VAS were anchored at 0cm(no pain) and 10cm(worst possible pain), the middle part shows varying degrees of pain, the greater of the number, the worse of the pain.|1hr, 6hr, 12hr, 24hr, and 48hr after surgery||||units on a scale||Standard Deviation|Mean
2541062|NCT03035916|Secondary|Questionnaire: Pain Scores at Rest|Pain scores of the participants will be measured by the Visual Analogue Scale. Measurement of VAS: Draw a 10cm horizontal line on the paper. The VAS were anchored at 0cm(no pain) and 10cm(worst possible pain), the middle part shows varying degrees of pain, the greater of the number, the worse of the pain.|1hr, 6hr, 12hr, 24hr, and 48hr after surgery||||units on a scale||Standard Deviation|Mean
2541063|NCT03035916|Secondary|Anesthetics Consumption: Sufentanil Consumption|Intraoperative superaddition of sufentanil was measured.|during operation||||ug||Standard Deviation|Mean
2541064|NCT03035916|Primary|Hemodynamic Parameters: Mean Arterial Pressure(MAP)|Continuous monitoring of mean arterial pressure(MAP) to 48 hours after surgery. mean arterial pressure(MAP)＝ (systolic blood pressure＋2×diastolic blood pressure)/3|up to 48h after surgery||||mmHg||Standard Deviation|Mean
2541065|NCT03035916|Primary|Hemodynamic Parameters: Heart Rate.|Continuous monitoring of heart rate to 48 hours after surgery.|up to 48h after surgery||||bpm||Standard Deviation|Mean
2541066|NCT03035916|Primary|Physiological Parameters: Plasma Concentration of Glucose (Glu)|When venous blood are collected, glucose levels are measured immediately by Glucometer.|up to 48h after surgery||||mmol/L||Standard Deviation|Mean
2541067|NCT03035916|Primary|Physiological Parameters: Plasma Concentration of Cortisol (Cor)|Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The Cor levels are measured by ELISA kits.|up to 48h after surgery||||mmol/L||Standard Deviation|Mean
2541068|NCT03035916|Primary|Physiological Parameters: Plasma Concentration of Epinephrine (E)|Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The E levels are measured by ELISA kits.|up to 48h after surgery||||pg/ml||Standard Deviation|Mean
2541069|NCT03035916|Primary|Physiological Parameters: Plasma Concentration of Norepinephrine (NE)|Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The NE levels are measured by ELISA kits.|up to 48h after surgery||||pg/ml||Standard Deviation|Mean
2541070|NCT03035864|Secondary|Changes in SANDE Scores (Face Values) for Frequency and Severity|"The Symptom Assessment in Dry Eye (SANDE) questionnaire is a short questionnaire to evaluate both dry eye intensity and frequency by using a 100 mm visual analogue scale (VAS). The patient symptoms of ocular dryness and/or irritation were quantified on the scale based on two questions that assessed both the severity and frequency of symptoms.~The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms."|From baseline to weeks 4, 8 and 12|Full Analysis Set Population. Observed values are reported.|||score on a scale||Standard Deviation|Mean
2541071|NCT03035864|Secondary|Changes in Cochet-Bonnet Corneal Aesthesiometry|"Corneal sensation was measured in both eyes in each of the four quadrants of the cornea using the Cochet Bonnet aesthesiometer before the instillation of any dilating or anesthetic eye drops. The handheld esthesiometer (Cochet-Bonnet) is a device that contains a thin, retractable, nylon monofilament that extends up to 6 cm in length. Variable pressure can be applied by the device by adjusting the length. The monofilament ranges from 60 mm to 5 mm and as the length is decreased the pressure increases from 11 mm/gm to 200 mm/gm.~Data for the main eye are reported."|From baseline to week 8|As of this secondary endpoint, FAS Population was taken into account, but the last observation carried forward (LOCF) imputation method was not applied.|||cm||Standard Deviation|Mean
2541072|NCT03035864|Secondary|Changes in Tear Film Break-Up Time (TFBUT)|"The TFBUT measurement was performed after instillation of 5 microliters of 2% sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient was instructed to blink several times to thoroughly mix the fluorescein with the tear film.~Data for the main eye are reported."|From baseline to weeks 4, 8 and 12|"As of this secondary endpoint, FAS Population was taken into account, but the last observation carried forward (LOCF) imputation method was not applied. Due to the reason mentioned above, the patients actually analysed (n) were the following:~Week 4 - 110 rhNGF Week 8 - 107 rhNGF Week 12 - 107 rhNGF"|||seconds||Standard Deviation|Mean
2541073|NCT03035864|Secondary|Changes in Conjunctiva Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)|"Conjunctival Staining was derived as the sum of scores of the conjunctival area (nasal-superior paralimbal, nasal-inferior paralimbal, nasal-peripheral, temporal-superior paralimbal, temporal-inferior paralimbal, temporal-peripheral) with a grading scale of 0-3 and with a minimum score of 0 and a maximal score of 18 (18 indicates the most abnormal score). Grades increase with the number and density of dots.~Data for the main eye are reported."|From baseline to weeks 4, 8 and 12|"As of this secondary endpoint, FAS Population was taken into account, but the last observation carried forward (LOCF) imputation method was not applied. Due to the reason mentioned above, the patients actually analysed (n) were the following:~Week 4 - 110 rhNGF; 58 vehicle Week 8 - 107 rhNGF; 58 vehicle Week 12 - 107 rhNGF; 55 vehicle"|||units on a scale||Standard Deviation|Mean
2541074|NCT03035864|Primary|Changes in Cornea Vital Staining With Fluorescein (National Eye Institute [NEI] Scales)|Corneal Staining was derived as the sum of scores of the five corneal sectors (central, superior, inferior, nasal, and temporal) each of which was scored on a scale of 0-3, with a minimum score of 0 and a maximal score of 15 (sum > 3 out of 15 is abnormal).|Baseline and Week 8|Full Analysis Set population. Last observation carried forward (LOCF) imputation method.|||score on a scale||Standard Deviation|Mean
2541089|NCT03035708|Secondary|Percent Heavy Drinking Days|The percentage of heavy drinking days during the last month of treatment (weeks 3-6). A heavy drinking day is defined as 4 or more drinks on a single day for females and 5 or more drinks on a single day for males.|Weeks 3-6|mITT|||percentage of heavy drinking days||Standard Error|Mean
2541075|NCT03035864|Primary|Change From Baseline in SANDE Scores for Frequency and Severity Assessed at 8 Weeks of Treatment.|"The Symptom Assessment in Dry Eye (SANDE) questionnaire is a short questionnaire to evaluate both dry eye intensity and frequency by using a 100 mm visual analogue scale (VAS). The patient symptoms of ocular dryness and/or irritation were quantified on the scale based on two questions that assessed both the severity and frequency of symptoms.~The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms."|Baseline and Week 8|Full Analysis Set Population. Last observation carried forward (LOCF) imputation method|||score on a scale||Standard Deviation|Mean
2541076|NCT03035760|Secondary|Time of Maximum Observed Concentration (Tmax) of Oxfendazole for Arm 4|Tmax was defined as the time at which the maximum concentration (Cmax) occurs in plasma computed from concentrations that were measured using a validated HPLCMS/MS method.|0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose|All participants are included in the analysis population.|||hours||Full Range|Median
2541077|NCT03035760|Secondary|Time of Maximum Observed Concentration (Tmax) of Oxfendazole for Arms 1, 2, and 3|Tmax was defined as the time at which the maximum concentration (Cmax) occurs in plasma computed from concentrations that were measured using a validated HPLCMS/MS method.|0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5|All participants are included in the analysis population.|||hours||Full Range|Median
2541078|NCT03035760|Secondary|Terminal Elimination Half-life (t1/2) of Oxfendazole for Arm 4|The apparent terminal elimination half-life (t1/2) was defined as the time required for the drug concentration to decrease by a factor of one-half in the terminal phase computed from concentrations that were measured using a validated HPLCMS/MS method.|0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose|All participants are included in the analysis population.|||hours||Standard Deviation|Mean
2541079|NCT03035760|Secondary|Terminal Elimination Half-life (t1/2) of Oxfendazole for Arms 1, 2, and 3|The apparent terminal elimination half-life (t1/2) was defined as the time required for the drug concentration to decrease by a factor of one-half in the terminal phase computed from concentrations that were measured using a validated HPLCMS/MS method.|0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5|All participants are included in the analysis population.|||hours||Standard Deviation|Mean
2541080|NCT03035760|Secondary|Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma for Arm 4|Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations computed from concentrations that were measured using a validated HPLC-MS/MS method.|0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose|All participants are included in the analysis population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2541081|NCT03035760|Secondary|Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma for Arms 1, 2, and 3|Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations computed from concentrations that were measured using a validated HPLC-MS/MS method.|0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5|All participants are included in the analysis population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2541082|NCT03035760|Secondary|Area Under the Concentration Time-curve to the Time of Last Measured Concentration (AUClast) of Oxfendazole for Arm 4|AUClast was defined as the area under the concentration-time curve from dosing to the time of the last measured concentration of that dosing period greater than the lower limit of quantification of the bioanalytical assay. AUClast was calculated using the Linear Up Log Down calculation method.|0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose|All participants are included in the analysis population.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2541083|NCT03035760|Secondary|Area Under the Concentration Time-curve for a Single Dosing Interval (AUCtau) of Oxfendazole for Arm 1, 2 and 3|AUCtau was defined as the total area under the concentration-time curve from dosing to the end of the 24-hour dosing interval for Dose 1 and Dose 5. AUCtau was calculated using the Linear Up Log Down calculation method.|0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5|All participants are included in the analysis population.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2541084|NCT03035760|Primary|Number of Subjects Reporting Adverse Events (AEs) Related to Oxfendazole for Arm 4|"All adverse events, defined as any untoward medical occurrence regardless of its causal relationship to the study treatment, were collected for 14 days after dosing. The PI then determined relatedness to the study drug. Related was defined as there is a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event."|Day 1 through Day 14|All participants are included in the analysis population.|||Participants|||Count of Participants
2541085|NCT03035760|Primary|Number of Subjects Reporting Adverse Events (AEs) Related to Oxfendazole for Arms 1, 2, and 3|"All adverse events, defined as any untoward medical occurrence regardless of its causal relationship to the study treatment, were collected for 14 days after dosing. The PI then determined relatedness to the study drug. Related was defined as there is a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event."|Day 1 through Day 10|All participants are included in the analysis population.|||Participants|||Count of Participants
2541086|NCT03035708|Secondary|Penn Alcohol Craving Scale|Penn Alcohol Craving Scale (higher numbers are indicative of more craving for alcohol); min = 0, max = 30. The measure was assessed at Study Weeks 3, 4, 5, and 6. The reported outcome is the adjusted mean total score across weeks 3-6.|Study Weeks 3, 4, 5, 6 (assessed weekly during this period)|mITT|||units on a scale||Standard Error|Mean
2541087|NCT03035708|Secondary|Cigarettes Smoked Per Week|The number of cigarettes smoked per week during the last month of treatment (weeks 3-6) computed only among participants who were smokers at baseline (varenicline n=11; placebo n=11). Note: cigarettes smoked per week outcome data was missing for two of the varenicline participants resulting in n=9 available for analysis.|Weeks 3-6|mITT|||cigarettes per week||Standard Error|Mean
2541253|NCT03030638|Primary|Baseline Characteristics of New Users of Olodaterol: Age|Baseline characteristics of patients in treatment group by data source: Age|Baseline|Study population|||Years||Inter-Quartile Range|Median
2541090|NCT03035708|Primary|Cue-elicited Craving|The primary outcome is cue-elicited alcohol craving, operationalized as the difference in Visual Analog Scale (VAS) craving for alcohol when exposed to an alcohol cue minus the VAS craving for alcohol when exposed to a water cue. The VAS has a minimum value of 0 and maximum value of 20; higher scores indicate more craving (a worse outcome).|Study Week 3|mITT|||units on a scale||Standard Error|Mean
2541091|NCT03035487|Primary|Keyword Description of Each Biopsy Sample|The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities. Keywords will be derived from standard lexicons such as PI-RADS for MRI and PRI-MUS for Micro-Ultrasound.|For each patient, keywords will be assigned within one week following the patient's procedure.||||percentage significant cancers detected|||Number
2541092|NCT03034967|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Danirixin in Whole Blood Using Dried Blood Spots|Blood samples were collected from the participants for the analysis of pharmacokinetic parameter.|Days 1 and 168|Pharmacokinetic Population.|||Hours||Full Range|Median
2541093|NCT03034967|Secondary|Concentration Maximum (Cmax) of Danirixin in Whole Blood Using Dried Blood Spots|Blood samples were collected from the participants for the analysis of pharmacokinetic parameter.|Days 1 and 168|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Nanogram per milliliter||95% Confidence Interval|Geometric Mean
2541094|NCT03034967|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration [AUC(0-t)] of Danirixin in Whole Blood Using Dried Blood Spot|Blood samples were collected at indicated timepoints for the analysis of phamacokinetic parameter. All participants in the PK population who had at least 1 non-missing PK assessment obtained and analyzed whilst on treatment with danirixin from a dry blood spot sample and corresponding wet whole blood sample were included in Pharmacokinetic population.|Days 1 and 168|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hour*nanogram per milliliter||95% Confidence Interval|Geometric Mean
2541095|NCT03034967|Secondary|Danirixin Whole Blood Pharmacokinetic Concentration-Time Data|Blood samples were collected from the participants for the analysis of blood pharmacokinetic concentration-time data. All participants in the mITT population who had at least 1 non-missing Pharmacokinetic assessment obtained and analyzed whilst on treatment with danirixin were included Pharmacokinetic population.|Pre-dose on Days 1, 56, 84 and 168; 0.5, 1, 2, 4, 6, 8, 10, 12 hours post-dose on Days 1 and 168|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Nanogram per milliliter||Standard Deviation|Mean
2541096|NCT03034967|Secondary|Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire|The Clinical Visit PROactive Physical Activity in COPD (C-PPAC) tool is a designed for intermittent use within a clinical study. PROactive Total Score and two domain scores (amount and difficulty) are derived using data from the C-PPAC questionnaire and a physical activity monitor worn for 7 days prior to the questionnaire.C-PPAC is a 12 item questionnaire. The PROactive tools are scored from 0 to 100 with higher scores indicating greater disease impact. It was implemented in a subset of approximately 50% of participants. The amount domain is calculated using 2 items from the C-PPAC questionnaire (amount of walking outside and chores outside) and 2 activity monitor outputs (vector magnitude units per minute (VMU/min) and steps/day). Each domain score is based on the addition of items (0-15 for amount and 0-40 for difficulty) and then scaled from 0-100. The total score is calculated as (amount+difficulty)/2.|Days 84 and 168|Per Protocol Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2541097|NCT03034967|Secondary|Change From Baseline Number of Puffs of Rescue Medication Per Day|The mean number of puffs of rescue per day was calculated over the same time periods and using the same assumptions as rescue use via diary. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.|Baseline, Months 1, 2, 3, 4, 5 and 6|Per Protocol Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the per protocol population without missing covariate information and with at least one post Baseline measurement are included in the analysis.|||Puffs per day||Standard Error|Least Squares Mean
2541098|NCT03034967|Secondary|Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment|Spirometric analysis was done to determine FEV1 and FVC. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline, Days 84 and 168|mITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the mITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.|||Ratio of FEV1/FVC||Standard Deviation|Mean
2541099|NCT03034967|Secondary|Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment|Spirometric analysis was done to determine FVC. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.|Baseline, Days 84 and 168|mITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the mITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
2541100|NCT03034967|Secondary|Percent Predicted Normal FEV1|Spirometric analysis was done to determine percent predicted FEVI at screening. FEV1 is forced expiratory volume in one second. Percent predicted FEV1 is defined as the percent FEV1 of the participant is divided by average FEV1 percent in the population of any person similar age, sex and body composition.|At Screening|Per Protocol Population. Only those participants with available data at the specified time points were analyzed.|||Percent predicted FEV1||Standard Deviation|Mean
2541254|NCT03030638|Secondary|Baseline Characteristics of New Users of Indacaterol: Age|Baseline characteristics of patients in treatment group by data source: Age|Baseline|Study population|||Years||Inter-Quartile Range|Median
2541101|NCT03034967|Secondary|Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment|Spirometric analysis was done to determine FEV1. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.|Baseline, Days 84 and 168|mITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the mITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
2541102|NCT03034967|Secondary|Number of CAT Responder|A participant was considered as a responder according to CAT score if their change from Baseline CAT score 2.0 units below Baseline or lower.|Day 84 and Day 168|Per Protocol Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2541103|NCT03034967|Secondary|Change From Baseline COPD Assessment Test (CAT) Total Score|The CAT is an 8 item questionnaire (cough, sputum, chest tightness, breathlessness, going up hills/stairs, activity limitation at home, confidence leaving the home, and sleep and energy) that measures health status of participants with COPD. Participants were completed each question by rating their experience on a 6 point scale ranging from 0 (maximum impairment) to 5 (no impairment) with a total scoring range of 0-40; higher scores indicate worse health status. A CAT score was calculated by summing the non-missing scores on the eight items. Individual items are scored from 0 to 5 with a total score range from 0 - 40, higher scores indicate greater disease impact. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.|Baseline, Days 84 and 168|Per Protocol Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the per protocol population without missing covariate information and with at least one post baseline measurement are included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2541104|NCT03034967|Secondary|Number of SGRQ Responder|A participant was consider Responder according to SGRQ total score if their change from Baseline SGRQ total score of 4 units below Baseline or lower.|Day 84 and Day 168|Per Protocol Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Number
2541105|NCT03034967|Secondary|Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score|The SGRQ-C consists of 40 items aggregated into 3 component scores: Symptoms, Activity, Impacts, and a Total score. Each response to a question is assigned a weight. Component scores are calculated by summing the weights from all positive items in that component, dividing by the sum of weights for all items in that component, and multiplying this number by 100. Component scores could range from 0-100, with a higher component score indicating greater disease burden. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.|Baseline, Days 84 and 168|Per Protocol Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the per protocol population without missing covariate information and with at least one post baseline measurement are included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2541106|NCT03034967|Secondary|HCRU-defined Exacerbation Duration|The duration of HCRU exacerbation were determined. The duration of the exacerbation was calculated as (exacerbation resolution date or date of death - exacerbation onset date + 1). For exacerbations which were not resolved but where the participant later died from other causes, the duration was calculated using date of death as the end date of the event.|Up to Day 196|Per Protocol Population. Only those participants with data available at the specified data points were analyzed.|||Days||Standard Deviation|Mean
2541107|NCT03034967|Secondary|Time to First Severe HCRU-defined COPD Exacerbation|A COPD exacerbation defined as a severe exacerbation if it requires hospitalization or ER visit or extended observation. The time to first on-treatment Moderate/Severe HCRU exacerbation was calculated as exacerbation onset date of first on-treatment moderate or severe on-treatment exacerbation - date of start of treatment +1.|Up to Day 196|Per Protocol Population.|||Days|||Number
2541108|NCT03034967|Secondary|Time to First HCRU-defined COPD Exacerbation|The time to first on-treatment Moderate/Severe HCRU exacerbation was calculated as exacerbation onset date of first on-treatment moderate or severe on-treatment exacerbation - date of start of treatment +1.|Up to Day 196|Per Protocol Population.|||Days|||Number
2541109|NCT03034967|Secondary|EXACT Event Duration for All Events|EXACT is a 14 item PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Severity is the highest EXACT total score during the period from onset to recovery. Duration of EXACT events has been reported.|Up to Day 168|Per Protocol Population. Only those participants with data available at the specified data points were analyzed.|||Days||Standard Deviation|Mean
2541110|NCT03034967|Secondary|Severity of EXACT Event|EXACT is a 14 item PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Severity is the highest EXACT total score during the period from onset to recovery.|Up to Day 168|Per Protocol Population. Only those participants with data available at the specified data points were analyzed|||Scores on a scale||Standard Deviation|Mean
2541111|NCT03034967|Secondary|Time to First EXACT Event|The time to first on-treatment EXACT event was calculated as the onset date of the first on-treatment EXACT event minus date of start of treatment plus 1.|Up to Day 168|Per Protocol Population.|||Days|||Number
2541112|NCT03034967|Secondary|Number of EXACT Events Per Participant|EXACT is a 14 item patient reported outcome (PRO) instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Events were categorized as recovered, censored, or persistent worsening. Number of EXACT events per participant has been presented, where 0= participants in each treatment group who did not experience an event; 1= participants in each treatment group who experienced 1 event and >=2= participants in each treatment group who experienced 2 or more events.|Up to Day 196|Per Protocol Population.|||Events|||Number
2541113|NCT03034967|Secondary|Number of Responders E-RS in COPD (E-RS): COPD Total Score|E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. E-RS is intended to capture information related to the respiratory symptoms of COPD, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness. The E-RS has a scoring range of 0-40; higher scores indicate more severe symptoms. Response is defined as an E-RS: COPD total score of 2 units below baseline or lower. Non-response is defined as an E-RS: COPD total score higher than 2 units below Baseline.|Month 6|Per Protocol Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the per protocol population without missing covariate information and with at least one post baseline measurement are included in the analysis.|||Participants|||Number
2541114|NCT03034967|Secondary|Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant|Participants with moderate or severe COPD exacerbations, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness analyzed. Mild exacerbations are defined as exacerbations that did not require treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization, Emergency Room [ER] visit or resulting in death). Moderate exacerbations are defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization, ER visit or resulting in death). Severe exacerbations are defined as exacerbations that required hospitalization, ER visit or resulted in death. Number of moderate or severe HCRU exacerbations per participant has been presented, where 0= participants in each treatment group who did not experience an event; 1= participants in each treatment group who experienced 1 event and >=2= participants in each treatment group who experienced 2 or more events.|Up to Day 196|Per Protocol Population.|||Exacerbations per participant|||Number
2541115|NCT03034967|Primary|Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings|Triplicate 12-lead ECG obtained to measure PR, QRS, QT, and Corrected QT intervals. Only those participants with worst case post-Baseline data have been represented for abnormal - not clinical significant and abnormal - clinical significant. Day 1 was considered as Baseline.|Baseline and Day 168|mITT population. Only those participants with available data at the specified time points were analyzed.|||Participants|||Count of Participants
2541116|NCT03034967|Primary|Number of Participants With Worst Case Vital Signs Parameter Results by PCI|Vital signs parameters includes systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse rate and respiration rate were measured in a semi-supine position after 5 minutes rest for the participants at indicated time points. PCI ranges for vital signs parameters were as follows: <90 to >160 millimeters of mercury (mmHg) for SBP and <40 to >110 mmHg for DBP, <35 or >120 beats per minute for heart rate and <8 or >30 breaths per minute for respiration rate. Values above and below this range were considered of PCI.|Up to Day 168|mITT population. Only those participants with available data at the specified time points were analyzed.|||Participants|||Count of Participants
2541117|NCT03034967|Primary|Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI|"Blood samples were collected from participants for analysis of following chemistry parameters with PCI low and high values: Alanine aminotransferase (ALT) International units per liter (IU/L) (High => 3x ULN), Alkaline phosphatase (ALP) (IU/L) (High ≥ 2x ULN); Aspartate aminotransferase (AST) (IU/L) (High=> 3x ULN); Bilirubin micromole per liter (umol/L) (High ≥ 2x ULN); Calcium millimole per liter (mmol/L) (Low 0.85x, high 1.08x), Chloride (mmol/L) (Low 0.90x, high 1.10x), Creatinine (umol/L) (High 1.30x), Direct bilirubin (umol/L) (High ≥ 2x ULN), Glucose (mmol/L) (Low <0.6x, high >4x), Potassium (mmol/L) (Low 0.75x, high 1.30x); Protein (g/L) (High 1.25x), Sodium (mmol/L) (Low 0.80x, high 1.15x), Multipliers are identified by x, otherwise actual comparison values are provided with units. Values above and below this range were considered of PCI."|Up to Day 196|mITT population. Only those participants with available data at the specified time points were analyzed (represented by n= X in the category titles)..|||Participants|||Count of Participants
2541118|NCT03034967|Primary|Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI)|"Blood samples were collected from participants for analysis of following hematology parameters with PCI low and high values: Basophils % (High 5.00x), Eosinophils % (High 2.00x), Mean corpuscular hemoglobin concentration (MCHC) gram per deciliter (g/dL) (Low 0.85x, high 1.10x), Mean corpuscular hemoglobin (MCH) picograms (pg) (Low 0.85x, high 1.20x), Mean corpuscular volume (MCV) femtoliter (fL) (low 0.25x, high 2.00x), Erythrocytes (Ery.)(10^12cells/L) (Low 0.93x, high 1.07x), Hematocrit (Ratio of 1) (Low 0.50x, high 0.50x), Hemoglobin gram per liter (g/L) (Low 0.85x, high 1.20x), Leukocytes (x10^9/L) (Low 0.70x, high 1.60x), Lymphocytes % (Low 0.80x, high 1.20x), Monocytes % (Low 0.80x, high 1.60x), Neutrophils % (Low 0.65x, high 1.50x), Platelets (x10^9cells/L) (Low 0.90x, high 1.10x). Multipliers are identified by x, otherwise actual comparison values are provided with units. Values above and below this range were considered of PCI."|Up to Day 196|mITT population. Only those participants with available data at the specified time points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2541119|NCT03034967|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.|Up to Day 196|Modified Intent-to-Treat (mITT) population. mIIT population comprised of all randomized participants who were randomized apart from those randomized in error, received a treatment randomization number, modified and data for this population were based on actual treatment received.|||Participants|||Count of Participants
2541120|NCT03034967|Primary|Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Chest Symptoms Score)|E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.|Baseline and Month 6|Per Protocol Population. Only those participants with data available at the specified data points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2541121|NCT03034967|Primary|Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Cough and Sputum Score)|E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.|Baseline and Month 6|Per Protocol Population. Only those participants with available data at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2541122|NCT03034967|Primary|Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Breathlessness Score)|E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.|Baseline and Month 6|Per Protocol Population. Only those participants with available data at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2541123|NCT03034967|Primary|Change From Baseline in Respiratory Symptoms Measured by Evaluating Respiratory Symptoms (E-RS) in COPD. E-RS: COPD Total Score|E-RS: COPD is a subset of Exacerbations of Chronic pulmonary Disease Tool (EXACT). E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range [0-17]), RS-cough and sputum (RS-CSP comprised of 3 items, score range [0-11]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range [0-12]). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Per protocol population included all participants from the mITT population who did not have a protocol deviation considered to impact efficacy. Posterior mean change and standard deviation has been presented.|Baseline and Month 6|Per Protocol Population. Only those participants with data available at the specified data points was analyzed.|||Scores on a scale||Standard Deviation|Mean
2541124|NCT03034954|Secondary|Frequency of Endorsement (%) for Mood Changes Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
2541125|NCT03034954|Secondary|Frequency of Endorsement (%) for Concentration Changes Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
2541126|NCT03034954|Secondary|Frequency of Endorsement (%) for Sleepiness Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
2541127|NCT03034954|Secondary|Frequency of Endorsement (%) for Skin Redness Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
2541128|NCT03034954|Secondary|Frequency of Endorsement (%) for Burning Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
2541129|NCT03034954|Secondary|Frequency of Endorsement (%) for Itching Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
2541130|NCT03034954|Secondary|Frequency of Endorsement (%) for Tingling Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
2541131|NCT03034954|Secondary|Frequency of Endorsement (%) for Scalp Pain Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
2541132|NCT03034954|Secondary|Frequency of Endorsement (%) for Neck Pain Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
2541133|NCT03034954|Secondary|Frequency of Endorsement (%) for Headache Item in Active and Sham Participants Undergoing HD-tDCS Session|"The side effects were assessed using a modified version of Brunoni et al. (2011) questionnaire. Participants rated common sensory experiences on a scale of None, Mild, Moderate, or Severe."|~1 minute post stimulation||||Participants|||Count of Participants
2541134|NCT03034954|Secondary|Blinding in Total Sample|Participants were asked to estimate which group they were in (i.e., active or sham).|~1 minute post stimulation||||Participants|||Count of Participants
2541189|NCT03033745|Secondary|Time to Onset of Local TEAEs|"Local Adverse Events: comprises all events reported within the MedDRA high level terms administration site reactions NEC, infusion site reactions, and injection site reactions. Only events are included which start prior to subject's start date of non-response."|At the end of 4 weeks for each planned infusion parameter|SAS|||Days|Local TEAEs|Standard Deviation|Mean
2541135|NCT03034954|Primary|Calculated Working Memory Performance Accounting for Simple Attention (Semantic 2-back d' Minus 0-back d')|The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During Semantic 2-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.|30 minutes post-stimulation|missing data for two participants|||d'||Standard Deviation|Mean
2541136|NCT03034954|Primary|Calculated Working Memory Performance Accounting for Simple Attention (2-back d' Minus 0-back d')|The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. By subtracting the 0-back d', the calculated score represents a more pure working memory measure. Scores closer to zero or positive represent better working memory performance.|30 minutes post-stimulation|missing data for 12 participants: 11 2-back (5 Active; 6 sham) due to Eprime miscalculation & one 0-back (Active)|||d'||Standard Deviation|Mean
2541137|NCT03034954|Primary|Performance (d') on a Working Memory (Semantic 2-back) Test|The n-back is a well validated measure of working memory. During Semantic-back, participants are asked to respond when a picture shown is in the same semantic category as the picture two items ago (e.g., both fruits). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.|30 minutes post-stimulation|missing data for eleven participants (5 Active; 6 Sham) due to Eprime miscalculation|||d'||Standard Deviation|Mean
2541138|NCT03034954|Primary|Performance (d') on a Working Memory (2-back) Test|The n-back is a well validated measure of working memory. During 2-back, participants are asked to respond when a picture shown is the exact same as two items ago. Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.|30 minutes post-stimulation|missing data for two participants|||d'||Standard Deviation|Mean
2541139|NCT03034954|Primary|Performance (d') on a Simple Attention (0-back) Test|The n-back is a well validated measure of working memory. During 0-back, participants are asked to respond by pressing a key when the picture on the screen is the same as the given target (e.g., a cow). Discriminability (d') is a measure of signal detection that accounts for signal to noise ratio. Higher scores represent better discriminability.|30 minutes post-stimulation|missing data for two participants|||d'||Standard Deviation|Mean
2541140|NCT03034954|Primary|Object Location Touchscreen Task (Version C) Recognition Average Time to Respond|The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition Average Response Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.|15 minutes after encoding|Missing data for one participant|||milliseconds||Standard Deviation|Mean
2541141|NCT03034954|Primary|Object Location Touchscreen Task (Version C) Recognition Total Correct|The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Recognition, participants are asked to select the correct location of an object from three options on the screen. Recognition total is the number of correct selections on all 15 trials. Higher scores represent better performance.|15 minutes after encoding|Missing data for one participant|||number of correct answers||Standard Deviation|Mean
2541142|NCT03034954|Primary|Object Location Touchscreen Task (Version C) Cued Recall Average Time to Respond|"The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the room or environment on the screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses."|15 minutes after encoding|Missing data for one participant|||milliseconds||Standard Deviation|Mean
2541143|NCT03034954|Primary|Object Location Touchscreen Task (Version C) Cued Recall Average Error|"The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the room or environment on the screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance."|15 minutes after encoding|Missing data for one participant|||centimeters||Standard Deviation|Mean
2541144|NCT03034954|Primary|Object Location Touchscreen Task (Version C) Cued Recall Total Error|"The Object Location Touchscreen Task (OLTT) requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Cued Recall, participants are shown the room or environment on the screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance."|15 minutes after encoding|Missing data for one participant|||centimeters||Standard Deviation|Mean
2541190|NCT03033745|Secondary|Rate of Local TEAEs Per Infusion|"Local adverse event rate per infusion = number of local adverse events/total number of infusions prior to subject's start date of non-response. Local Adverse Events: comprises all events reported within the MedDRA high level terms administration site reactions NEC (Not Elsewhere Classified), infusion site reactions, and injection site reactions. Only events are included which start prior to subject's start date of non-response."|At the end of 4 weeks for each planned infusion parameter|SAS|||Number of local TEAEs/infusion|Infusions||Number
2541145|NCT03034954|Primary|Object Location Touchscreen Task (Version C) Free Recall Average Time to Respond|The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Time is the average latency to respond across all 15 trials. Lower scores represent faster responses.|15 minutes after encoding|Missing data for one participant|||milliseconds||Standard Deviation|Mean
2541146|NCT03034954|Primary|Object Location Touchscreen Task (Version C) Free Recall Average Error|The Object Location Touchscreen Task (OLTT) is a measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a blank screen and asked to touch the area of the screen an object was located. Average Score is the average error across all 15 trials. Lower scores represent better performance.|15 minutes after encoding|Missing data for one participant|||centimeters||Standard Deviation|Mean
2541147|NCT03034954|Primary|Object Location Touchscreen Task (Version C) Free Recall Total Error|The Object Location Touchscreen Task (OLTT) is an ecologically relevant measure of object location association memory. The OLTT requires participants to learn and recall the location of 15 object-location associations. Memory is evaluated using a touchscreen monitor, which allows for the continuous measurement of memory accuracy (i.e., distance from targeted location). During the Free Recall, participants are given a black screen and asked to touch the area of the screen an object was located. Total Score is the sum of error for all 15 trials. Lower scores represent better performance.|15 minutes after encoding|Missing data for one participant|||centimeters||Standard Deviation|Mean
2541148|NCT03034928|Primary|Average Percent Area of Solution-related Corneal Staining|Percent of solution-related corneal staining area was assessed first in each of the 5 corneal regions: central, superior, nasal, inferior, and temporal. The average of corneal staining area was then calculated as the average over all 5 regions. A higher percentage reflects more damage to the corneal surface. Both eyes contributed to the analysis. No hypotheses were formulated; no inferences were made and only descriptive statistics were used in the reporting.|Day 1 after 2 hours of wear, each product|This analysis population includes all randomized subjects who satisfied protocol-specified criteria (Full Analysis Set).|||percentage of area||Standard Deviation|Mean
2541149|NCT03034915|Secondary|Number of Participants With on Treatment Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant , temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events associated with liver injury and impaired liver function based on pre-defined criteria were categorized as SAE.|Up to Week 24|ITT Population.|||Participants|||Number
2541150|NCT03034915|Secondary|Percentage of Responders According to CAT|The CAT is a participant-completed instrument designed to provide a simple and reliable measure of health status in COPD for the assessment and long-term follow-up of the individual participant. The CAT consists of eight items. Participants rated their experience on a 6-point scale for each question, ranging from 0 (no impact) to 5 (high impact). A total CAT score was calculated by summing the non-missing scores on the eight items ranging from 0 to 40 with higher scores indicate greater disease impact. Response was defined as an CAT score of >=2 below Baseline. Non response was defined as CAT score <2 units below Baseline or a missing CAT score with no subsequent on treatment scores. Analysis performed using a generalized linear mixed model with treatment as an explanatory variable and visit, baseline CAT score, stratum (no. of bronchodilators per day during run-in), geographical region, visit by baseline and visit by treatment interactions included as covariates.|Week 24|ITT Population.|||Percentage of responders|||Number
2541151|NCT03034915|Secondary|Change From Baseline in COPD Assessment Test (CAT)|The CAT is a participant-completed instrument designed to provide a simple and reliable measure of health status in COPD for the assessment and long-term follow-up of the individual participant. The CAT consists of eight items, each formatted on a differential scale. Participants rated their experience on a 6-point scale for each question, ranging from 0 (no impact) to 5 (high impact). A total CAT score was calculated by summing the non-missing scores on the eight items ranging from 0 to 40 with higher scores indicating greater disease impact. Baseline is defined as the last non-missing score recorded prior to dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the value at Week 24. Analysis was performed using mixed model repeated measures (MMRM) with covariates of Baseline CAT score, geographical region, stratum (no. of bronchodilators per day during run-in), visit, treatment, visit by Baseline and visit by treatment interactions.|Baseline (Pre-dose on Day 1) and Week 24|ITT population. Participants represents those with data available at the time point being presented; however, all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2541152|NCT03034915|Secondary|Percentage of Responders Based on the Saint (St) George Respiratory Questionnaire COPD Specific (SGRQ) Total Score|SGRQ is a disease-specific questionnaire designed to measure impact of respiratory disease and its treatment on HRQoL of participants with COPD. It contains 14 questions with a total of 40 items grouped into domains (Symptoms, Activity and Impacts). SGRQ total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. It ranges from 0 to 100, higher score indicates poor HRQoL. Analysis was performed using a generalized linear mixed model with treatment as an explanatory variable and visit, Baseline SGRQ score, stratum (no. of bronchodilators per day during run-in), geographical region, visit by Baseline and visit by treatment interactions included as covariates. Response was defined as an SGRQ total score of 4 or more units below Baseline.|Week 24|ITT Population. Participants represents those with data available at the time point being presented; however, all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.|||Percentage of responders|||Number
2541153|NCT03034915|Secondary|Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score|SGRQ is a disease-specific questionnaire designed to measure impact of respiratory disease and its treatment on HRQoL of participants with COPD. It contains 14 questions with a total of 40 items grouped into domains (Symptoms, Activity and Impacts). SGRQ total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. It ranges from 0 to 100, higher score indicates poor HRQoL. Baseline is last non-missing score recorded prior to dosing on Day 1. Change from Baseline was calculated by subtracting Baseline value from the value at Week 24. Analysis was performed using mixed model repeated measures (MMRM) with covariates of Baseline SGRQ total score, geographical region, stratum (no. of bronchodilators per day during run-in), visit, treatment, visit by Baseline and visit by treatment interactions.|Baseline (Pre-dose on Day 1) and Week 24|ITT Population. Participants represents those with data available at the time point being presented; however, all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2541154|NCT03034915|Secondary|Percentage of E-RS Responders According to E-RS Total Score|The E-RS is intended to capture information related to respiratory symptoms. A daily symptom score for E-RS is derived by summing 11 item-scores. The domains include: RS-BRL comprised of 5 items, score range (0-17); RS-CSP comprised of 3 items, score range (0-11); and RS-CSY comprised of 4 items, score range (0-12). Total score ranged between 0-40 and higher values indicates severe respiratory symptoms. The instrument was completed each night prior to going to bed. Response is defined as an E-RS total score of at least 2 or 3.35 below Baseline. Participants with a Baseline but all missing post-Baseline data are also considered a non-responder. Analysis was performed using a generalized linear mixed model with treatment as an explanatory variable and four-weekly period, Baseline score, stratum (no. of bronchodilators per day during run-in), geographical region, four-weekly period by baseline and four-weekly period by treatment interactions included as covariates.|Week 21 to Week 24|ITT Population. Participants represents those with data available at the time point being presented; however, all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.|||Percentage of responders|||Number
2541155|NCT03034915|Secondary|Mean Change From Baseline in E-RS Subscale Score|The E-RS is intended to capture information related to respiratory symptoms. A daily symptom score for E-RS is derived by summing 11 item-scores. The domains include: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range [0-17]), RS-cough and sputum (RS-CSP comprised of 3 items, score range [0-11]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range [0-12]). Total score ranged between 0-40 and higher values indicates severe respiratory symptoms. The instrument was completed each night prior to going to bed. Baseline E-RS score is the mean within-participant daily score over 7 days prior to randomization. Change from Baseline is the difference at Week 21-Week 24 value and Baseline value. Analysis was performed using MMRM with covariates of Baseline score, geographical region, stratum (no. of bronchodilators per day during run-in), 4-weekly period, treatment, 4-weekly period by Baseline and 4-weekly period by treatment interactions.|Baseline (Pre-dose on Day 1) and Week 21 to Week 24|ITT Population. Participants represents those with data available at the time point being presented; however, all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2541156|NCT03034915|Secondary|Mean Change From Baseline in Evaluating Respiratory Symptoms (E-RS) Total Score|The E-RS is intended to capture information related to respiratory symptoms. A daily symptom score for E-RS is derived by summing 11 item-scores. The domains include: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range [0-17]), RS-cough and sputum (RS-CSP comprised of 3 items, score range [0-11]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range [0-12]). Total score ranged between 0-40 and higher values indicates severe respiratory symptoms. The instrument was completed each night prior to going to bed. Baseline E-RS score is the mean within-participant daily score over 7 days prior to randomization. Change from Baseline is the difference at Week 21-Week 24 value and Baseline value. Analysis was performed using MMRM with covariates of Baseline score, geographical region, stratum (no. of bronchodilators per day during run-in), 4-weekly period, treatment, 4-weekly period by Baseline and 4-weekly period by treatment interactions.|Baseline (Pre-dose on Day 1) and Week 21 to Week 24|ITT Population. Participants represents those with data available at the time point being presented; however, all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2541157|NCT03034915|Secondary|Percentage of TDI Responders According to SAC TDI Focal Score|TDI focal score comprises of 3 individual scales (Functional Impairment, Magnitude of Task, Magnitude of Effort). Each of these scales had a possible score ranging from -6 to +6, lower scores indicates impairment. TDI focal score was calculated as the sum of 3 individual scores (range is -18 to +18). Lower score indicates deterioration of dyspnea. If a score is missing for any of the three scales, then TDI focal score was set to missing. A participant was considered as a responder if the on-treatment TDI focal score was at least 1 unit at that visit. Non-response was SAC TDI focal score of less than 1 unit or a missing SAC TDI focal score with no subsequent non-missing on-treatment scores. Analysis was performed using a generalized linear mixed model with treatment as an explanatory variable and visit, SAC BDI focal score, stratum (no. of bronchodilators per day during run-in), geographical region, visit by SAC BDI and visit by treatment interactions included as covariates.|Week 24|ITT Population. Participants represents those with data available at the time point being presented; however, all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.|||Percentage of responders|||Number
2541178|NCT03034044|Primary|Number of Participants With Less Than Expected Therapeutic Effect (LETE): On-Demand Treatment According to Surgery|"LETE for on-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) was defined as no response rated after each infusion of 2 consecutive infusions within 24 hours after on-demand treatment."|Within 24 hours of on-demand treatment (anytime within the observation period of 6 months)|The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, “Overall Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2541158|NCT03034915|Secondary|Self Administered Computerized (SAC) Transient Dyspnea Index (TDI) Focal Score at Week 24|TDI focal score comprises of 3 individual scales (Functional Impairment, Magnitude of Task, Magnitude of Effort). Each of these scales had a possible score ranging from -6 to +6, lower scores indicates impairment. TDI focal score was calculated as the sum of 3 individual scores (range is -18 to +18). Lower score indicates deterioration of dyspnea. If a score is missing for any of the three scales, then the TDI focal score was set to missing. Analysis was performed using mixed model repeated measures (MMRM) with covariates of SAC BDI focal score, geographical region, stratum (no. of bronchodilators per day during run-in), visit, treatment, visit by SAC BDI and visit by treatment interactions.|Week 24|ITT Population. Participants represents those with data available at the time point being presented; however, all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2541159|NCT03034915|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 24|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 at Week 24 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on the previous day. Baseline trough FEV1 is the mean of the values measured at 30 minutes and 5 minutes pre-dose on Day 1. Change from Baseline was calculated as the trough FEV1 value on Week 24 minus the Baseline value. Analysis was performed using a repeated measures model (MMRM) with covariates of Baseline FEV1, geographical region, stratum (number of bronchodilators per day during run-in), visit, treatment, visit by Baseline and visit by treatment interaction. ITT population comprised of all randomized participants (excluding those who were randomized in error) who received at least one dose of study medication.|Baseline (Pre-dose on Day 1) and Week 24|ITT Population. Participants represents those with data available at the time point being presented; however, all participants in the ITT population without missing covariate information and with at least one post Baseline measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
2541160|NCT03034577|Secondary|Duration of Hospital Length of Stay|Duration of hospital length of stay following their procedure until hospital discharge|3 days|Duration of hospital length of stay following their procedure until hospital discharge|||days||Standard Deviation|Mean
2541161|NCT03034577|Secondary|Number of Participants Categorized by Level of Surgical Satisfaction|Overall surgical satisfaction using a 1-5 Likert scale (1 = very unacceptable, 2 = unacceptable, 3 = acceptable, 4 = good, 5 = excellent).|2 hours|Surgical operating conditions|||participants|||Number
2541162|NCT03034577|Secondary|Duration of Anesthesia From Induction to Cessation of the Anesthetic|Duration of Anesthesia from induction to cessation of the anesthetic up to 6 hours|Up to 6 hours|Duration of Anesthesia from induction to cessation of the anesthetic|||minutes||Standard Deviation|Mean
2541163|NCT03034577|Secondary|Number of Participants With Full Reversal of Neuromuscular Blockade Prior to Extubation|Compliance with protocol to ensure deep block or light/moderate block, using the train of four ratio and post tetanic count|6 hours|Full reversal prior to extubation (4 twitches and TOF ratio >0.9)|||participants|||Number
2541164|NCT03034577|Secondary|Percentage of Patients Recovered in All Domains of the Postoperative Quality of Recovery Scale at 3 Months After the Operation|Recovery for all domains and within domains of the PostopQRS scale at the other time points of measurement (15 minutes, 40 minutes 1 day, 3 days, 1 and 2 weeks, and 3 months following cessation of anesthesia). The domains of recovery are physiological, nociceptive, emotive activities of daily living, cognitive and overall patient perspective.|3 months|Recovery in all domains of the Postoperative Quality of Recovery Scale at 3 months after the operation|||percentage of patients recovered|||Number
2541165|NCT03034577|Primary|Percentage of Patients Recovered Cognitively at 1 Week|The primary outcome will be the cognitive domain at 1 week after surgery, when it is expected that most of the acute inflammation will have resolved, and analgesia requirements minimal.|1 week|There were 31 participants who did not complete the cognitive assessment at 1 week in the moderate neuromuscular blockade group, whereas there were 35 participants who did not complete the cognitive assessment at 1 week in the deep neuromuscular blockade group|||percentage of patients recovered|||Number
2541166|NCT03034057|Secondary|Continuation Rate for the Method (Self-injection With Sayana Press) at 1 Year|Continuation rate for the method at 1 year equals: ([the number of participants who received all 4 injections and had not discontinued by 12 months] / [total number of participants in the study]) *100%. A 95% CI was calculated along with the continuation rate using normal approximation to the binominal.|1 year|The analysis population included participants who enrolled into the study.|||Percentage of total participants||95% Confidence Interval|Number
2541167|NCT03034057|Primary|Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Sensitivity Analysis)|Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by GEE model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% CI for the intercept was transformed to a 95% CI for the self-injection success rate. The sensitivity analysis was conducted to eliminate the data from the discontinued site due to ongoing Good Clinical Practice (GCP) violations.|Up to 1 year|The analysis population included participants who enrolled into the study. Participants at sites which required closure during study due to GCP violations were excluded from the analysis population.|||Percentage of all attempts at home||95% Confidence Interval|Number
2541188|NCT03033745|Secondary|Intensity of Local TEAEs|Mild = A type of AE that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. Moderate = A type of AE that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the subject. Severe = A type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Only events are included which start prior to subject's start date of non-response.|At the end of 4 weeks for each planned infusion parameter|SAS|||Participants|||Count of Participants
2541168|NCT03034057|Primary|Percentage of Successful Self-Injections Performed of All Attempts at Home on Schedule (Full Analysis Set)|Each participant had a maximum of 3 home self-injections, each of which was defined as a success or failure. A success was defined as a home self-injection that was successfully performed by the participant at home and on schedule (13 week interval +/- 1 week) where all attempts were included in the denominator. If the participant attempted but was unable to administer the self-injection at home and had it performed instead at the clinic, then these were classed as failures. This outcome measure was analyzed by generalized estimating equation (GEE) model using participant as the clustering variable. The GEE model used the logit link and contained an intercept term. The 95% confidence interval (CI) for the intercept was transformed to a 95% CI for the self-injection success rate.|Up to 1 year|The analysis population included participants who enrolled into the study.|||Percentage of all attempts at home||95% Confidence Interval|Number
2541169|NCT03034044|Primary|Total Factor VIII Consumption|Total factor VIII consumption for each participant was calculated by sum of the total amount of Xyntha Solofuse (in IU) infused for each Xyntha Solofuse infusion.|6 months|The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, “Overall Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||IU||Standard Deviation|Mean
2541170|NCT03034044|Primary|Average Dose of Infusions Per Bleeding Event: Prophylactic Therapy|The average dose of Xyntha per bleeding event according to prophylaxis therapy treatment was calculated as total dose of Xyntha (in IU) throughout the study divided by total number of bleeding event. Prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleeding occurred within 48 hours of prophylaxis infusion (defined as administration of Xyntha not for the treatment of a bleed but for the prevention of bleeding).|From the first administration of Xyntha up to 6 months|The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, “Overall Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||IU/event||Standard Deviation|Mean
2541171|NCT03034044|Primary|Number of Participants With Less Than Expected Therapeutic Effect (LETE): Prophylactic Therapy|Less than expected therapeutic effect for prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleeding occurred within 48 hours of prophylaxis infusion (defined as: administration of Xyntha not for the treatment of a bleed but for the prevention of bleeding).|From the first administration of Xyntha up to 6 months|The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, “Overall Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2541172|NCT03034044|Primary|Annualized Bleeding Rates (ABRs)|Annualized bleeding rate defined as number of bleeds under prophylactic setting (defined as bleeding occurred after 48 hours of prophylactic therapy [administration of Xyntha not for the treatment of a bleed but for the prevention of bleeding]) divided by (/) [(number of prophylactic therapy participants)*0.5)]|Within 48 hours after the prophylactic administration of Xyntha (within the duration of 6 months)|The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, “Overall Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||bleeds per participant|||Number
2541173|NCT03034044|Primary|Percentage of Participants With Bleeding Event||From the first administration of Xyntha up to 6 months|The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, “Overall Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2541174|NCT03034044|Primary|Average Dose of Infusions Per Bleeding Event: On-Demand Treatment According to Bleeding|The average dose of Xyntha per bleeding event was calculated as total dose of Xyntha throughout the study (in International Units [IU]) divided by total number of bleeding incidence. On-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to bleeding means treatment administered due to spontaneous bleeding or abrasion.|From the first administration of Xyntha up to 6 months|The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, “Overall Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||IU/event||Standard Deviation|Mean
2541175|NCT03034044|Primary|Average Dose of Infusions Per Bleeding Event: On-Demand Treatment According to Surgery|The average dose of Xyntha per bleeding event according to surgery in on-demand treatment was calculated as total dose of Xyntha (in IU) throughout the study divided by total number of bleeding event. On-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to surgery means treatment to increase factor in preparation for surgery.|From the first administration of Xyntha up to 6 months|The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, “Overall Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||IU/event||Standard Deviation|Mean
2541176|NCT03034044|Primary|Number of Infusions Required to Treat Each New Bleeding Episode|It was calculated as total number of injections given throughout the study divided by total number of bleeding events.|From the first administration of Xyntha up to 6 months|The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, “Overall Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||Infusions||Standard Deviation|Mean
2541177|NCT03034044|Primary|Number of Participants With Less Than Expected Therapeutic Effect (LETE): On-Demand Treatment According to Bleeding|"LETE for on-demand treatment ((administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) was defined as no response rated after each infusion of 2 consecutive infusions within 24 hours after on-demand treatment) was defined as no response rated after each infusion of 2 consecutive infusions within 24 hours after on-demand treatment."|Within 24 hours of on-demand treatment (anytime within the observation period of up to 6 months)|The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, “Overall Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2541179|NCT03034044|Primary|Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Bleeding|On-demand treatment according to bleeding: treatment administered for spontaneous bleeding/abrasion; not requiring surgery. Overall responses to all injection of Xyntha used to treat bleeding in on-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to bleeding was assessed on 4 point scale of 1=excellent, 2=good, 3=moderate,4=no response, higher score=better response. Excellent= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with no additional infusion, good= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with 1 additional infusion, moderate= Probable/slight improvement after 8 hours following infusion, with >=1 additional infusion administered for complete resolution of bleeding episode and no response= No improvement at all between infusions/during 24 hour interval following an infusion, or condition worsens.|From the first administration of Xyntha up to 6 months|The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, “Overall Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2541180|NCT03034044|Primary|Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Surgery|On-demand treatment according to surgery: treatment to increase factor in preparation for surgery. Overall responses to all injection of Xyntha Solofuse prefilled syringe used to treat bleeding in on-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to surgery was assessed on 4 point scale of 1=excellent, 2=good, 3=moderate and 4=no response, higher score = better response. Excellent= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with no additional infusion, good= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with 1 additional infusion, moderate= Probable/slight improvement starting after 8 hours following infusion, with >=1 additional infusion administered for complete resolution of bleeding episode and no response= No improvement at all between infusions/during 24 hour interval following an infusion/condition worsens|From the first administration of Xyntha up to 6 months|The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, “Overall Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2541181|NCT03034044|Primary|Number of Participants Who Died Due to Adverse Events|An AE was any untoward medical occurrence in participants who received Xyntha without regard to possibility of causal relationship.|From the first administration of Xyntha up to 6 months|The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe.|||Participants|||Count of Participants
2541182|NCT03034044|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events|Treatment-related AE was any untoward medical occurrence attributed to Xyntha in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to treatment was assessed by investigator. AEs included both serious and non-serious AEs.|From the first administration of Xyntha up to 6 months|The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe.|||Participants|||Count of Participants
2541183|NCT03034044|Primary|Number of Participants Who Discontinued Due to Adverse Events|An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship.|From the first administration of Xyntha up to 6 months|The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe.|||Participants|||Count of Participants
2541184|NCT03034044|Primary|Number of Participants With Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in participants who received Xyntha without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function, and was determined based on investigator's discretion.|From the first administration of Xyntha up to 6 months|The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, “Overall Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2541185|NCT03034044|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in participants who received Xyntha without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment Emergent Adverse Event (TEAE) was adverse event that started or worsened in severity after first administration of Xyntha Solofuse up to 6 months. AEs included both serious and non-serious adverse event.|From the first administration of Xyntha up to 6 months|The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe.|||Participants|||Count of Participants
2541186|NCT03033745|Secondary|Tolerability of Infusions|Tolerability = number of infusions without severe local adverse events / total number of infusions. Severe = A type of AE that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Only events are included which start prior to subject's start date of non-response.|At the end of 4 weeks for each planned infusion parameter|SAS|||Ratio|Infusions||Number
2541187|NCT03033745|Secondary|Duration of Local TEAEs|"Local Adverse Events: comprises all events reported within the MedDRA high level terms administration site reactions NEC, infusion site reactions, and injection site reactions."|At the end of 4 weeks for each planned infusion parameter|SAS|||Days|Local TEAEs|Standard Deviation|Mean
2541191|NCT03033745|Secondary|Rate of Treatment-emergent Adverse Events (TEAEs) Per Infusion|Adverse event rate per infusion = number of adverse events/total number of infusions prior to subject's start date of non-response. Only events are included which start prior to subject's start date of non-response.|At the end of 4 weeks for each planned infusion parameter|SAS|||Number of TEAEs/infusion|Infusions||Number
2541192|NCT03033745|Primary|Percentage of Responders|A responder is a subject within the Pump-Assisted Cohorts that performs at least 3 out of 4 valid infusions at a certain infusion parameter level (weekly volumes per injection site of 25-50 mL; weekly flow rates per injection site of 25-100 mL/hour). Determination of a responder in the Manual Push Cohort is more complex due to the expected variable frequency of infusions per week (ie, 5-17) for different subjects. A responder within the Manual Push Cohort is a subject that performs a minimum number of valid infusions during 4 weeks corresponding to a certain flow rate level ([ie, 2-7 times per week], flow rates per injection site of 30-120 mL/hour). Valid infusions do not need to be consecutive, but each subject needs to adhere to the same schedule (number of infusions per week) throughout the study. An infusion parameter will be considered successful if at least one third (≥ 33%) of the subjects in the corresponding cohort are responders at that infusion parameter level.|At the end of 4 weeks for each planned infusion parameter|The Safety Analysis Set (SAS) comprised all subjects in the Full Analysis Set who received ≥ 1 dose or a partial dose of IgPro20 in the study.|||percentage of responders|||Number
2541193|NCT03033134|Other Pre-specified|Warfarin Discontinuation Rate|Warfarin discontinuation rate per protocol. If the TEE shows adequate seal of the LAA with a jet around the device <= 5mm, warfarin therapy should be discontinued.|till 6-month|Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.|||Participants|||Count of Participants
2541194|NCT03033134|Other Pre-specified|Technical Success Rate|Technical Success defined as successful delivery and release of BSJ003W into the LAA including successful recapture and retrieval if necessary.|Implant Day|Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.|||Participants|||Count of Participants
2541195|NCT03033134|Secondary|Number of Participants With Ischemic Stroke or Systemic Embolism|The occurrence of ischemic stroke or systemic embolism (excluding 7 days after implanting or day after hospital discharge whichever is the later)|6-month|Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.|||Participants|||Count of Participants
2541196|NCT03033134|Secondary|Number of Participants With Clinically Overt Non-fatal Bleeding|"Clinically overt non-fatal bleeding is defined as per BARC bleeding definition type 2.~Type 2: any overt, actionable sign of hemorrhage (eg, more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for type 3, 4, or 5 but does meet at least one of the following criteria: (1) requiring nonsurgical, medical intervention by a healthcare professional, (2) leading to hospitalization or increased level of care, or (3) prompting evaluation"|0 - 6 months|0 - 6 months|||Participants|||Count of Participants
2541197|NCT03033134|Secondary|Number of Participants With Major Bleeding|"Major bleeding is defined as per BARC bleeding definition type 3 or 5.~Type 3 Type 3a: Overt bleeding plus hemoglobin drop of 3 to 5 g/dL* (provided hemoglobin drop is related to bleed), Any transfusion with overt bleeding~Type 3b: Overt bleeding plus hemoglobin drop 5 g/dL* (provided hemoglobin drop is related to bleed) Cardiac tamponade, Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), Bleeding requiring intravenous vasoactive agents~Type 3c: Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal), Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision~Type 5: fatal bleeding Type 5a: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious Type 5b: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation"|0 - 6 months|Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.|||Participants|||Count of Participants
2541198|NCT03033134|Primary|The Rate of Effective Left Atrial Appendage (LAA) Closure|"The effective LAA closure is defined as peri-device flow <= 5mm demonstrated by TEE.~TEE measurements will be assessed by an independent Core Laboratory."|45-day, 6-month|"Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.~One subject in Roll-in cohort at 6-month was not able to assessed by the Core laboratory due to the quality of the images"|||Participants|||Count of Participants
2541199|NCT03033134|Primary|Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause)|The occurrence of composite events including stroke (all/ ischemic/ hemorrhagic), systemic embolism and cardiovascular death (including unexplained cause) till 6-month post implant|6-month|Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.|||Participants|||Count of Participants
2541200|NCT03033134|Primary|Number of Participants With Complications; One of the Following Events|All-cause death, ischemic stroke, systemic embolism, or device- or procedure- related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, arteriolar-venular fistula repair, or other major endovascular repair.|Between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later||||Participants|||Count of Participants
2541201|NCT03032965|Secondary|Incidence of Death|Number of deaths within 90 days of the procedure.|with 90 days of the procedure||||Participants|||Count of Participants
2541202|NCT03032965|Secondary|Incidence of Atrio-esophageal Fistula|Number of subjects who develop connection between heart and the esophagus|within 4 weeks||||Participants|||Count of Participants
2541203|NCT03032965|Secondary|Incidence of Cardiac Perforation|Number of subjects who develop perforation of heart during ablation|within 24 hours||||Participants|||Count of Participants
2541204|NCT03032965|Secondary|Incidence of Pulmonary Vein Stenosis|Number of subjects who develop Symptomatic pulmonary vein stenosis|6 months post-procedure||||Participants|||Count of Participants
2541205|NCT03032965|Secondary|Incidence of Stroke|Number of subjects who develop stroke within 30 days after procedure.|peri-procedural (0 to 30 days after procedure)||||Participants|||Count of Participants
2541220|NCT03032263|Primary|Number of Participants Requiring Use of Magill Forceps for Nasal Intubations|Reported as the number and percentage of participants that needed the use of Magill forceps during intubation|1 day||||Participants|||Count of Participants
2541206|NCT03032965|Secondary|Number of Pulmonary Veins That Recovered Conduction During Repeat Ablation Procedures in Both Groups|Prevalence of recovery of conduction into pulmonary veins during repeat ablation procedures in both groups. This is determined by surgeon assessment using a circular mapping catheter to identify recovery of conduction into the pulmonary veins.|post-procedure (6 months)|Only 21 participants had repeat ablations; each participant has four pulmonary veins therefore the number of connections measured is based 4 x the number of participants|||pulmonary veins|pulmonary veins||Count of Units
2541207|NCT03032965|Secondary|Number of Subjects With AF or Atrial Flutter/Tachycardia Occurring During the First Three Months Post Ablation||first three months post ablation|This data was not collected.||||||
2541208|NCT03032965|Secondary|Number of Subjects Who Need Repeat Ablations|Number of participants who had one or more repeat ablation procedures due to documented recurrence of Symptomatic AF or atrial flutter/tachycardia.|date of ablation to 6 months after procedure||||Participants|||Count of Participants
2541209|NCT03032965|Primary|Freedom From Any Atrial Arrhythmias|Primary endpoint of the study will be number of participants who are free from any atrial arrhythmias after a single ablation procedure in the absence of antiarrhythmic drug therapy|2- 14 months after Ablation procedure||||Participants|||Count of Participants
2541210|NCT03032523|Secondary|Specificity of CGM to Detect Hypoglycemic Events|True negative rate|up to 7 days|12 participants had sensor data for analysis. 3 were excluded from the remote monitoring group for the analysis. Blinded CGM participants did not have a verification glucose check, thus specificity could not be calculated on these participants.|||% of true negative events|||Number
2541211|NCT03032523|Secondary|Sensitivity of the CGM to Detect Hypoglycemia.|True positive rate.|up to 7 days|Participants in the Remote Monitoring CGM Group were analyzed. 3 were excluded from the remote monitoring group for the analysis. Those in the blinded group were unable to be analyzed because the CGM was blinded and did not prompt a BG check.|||% of true hypoglycemic events|||Number
2541212|NCT03032523|Primary|Sensor-detected Hypoglycemia|Reported values in the table represent the cumulative number of hypoglycemic events detected by the sensor that were not detected by the hospital standard of care measures across all participants.|up to 8 days|Participants in the remote monitoring group were eligible for analysis. 3 were excluded from the remote monitoring group for the analysis. Blinded CGM participants did not have a verification glucose check, thus sensor-detected hypoglycemia was not verified, and thus were not reported in the analysis.|||events|||Number
2541213|NCT03032510|Secondary|Proportion of Participants in the ITT Population With Favorable Clinical Outcomes at TOC Visit|"Clinical cure: A complete resolution or significant improvement of signs or symptoms of the infection such that no rescue/non-study antibacterial medication was required to treat the cUTI that presented at study entry.~Clinical failure: Subjects were classified as clinical failure in the event of~Death related to cUTI at any timepoint~Persistence of clinical symptoms of cUTI or new symptoms developed~Initiation of rescue/non-study antibacterial medication for cUTI Indeterminate: Study data were listed as indeterminate if the outcome was other than clinical cure or clinical failure. The reason for an indeterminate designation had to be provided Missing: Study data were listed as missing if the Investigator did not complete an assessment or if the subject did not complete the study visit."|TOC visit (14-17 days after randomization)|ITT included all randomized participants, regardless of receiving study drug or not.|||Participants|||Count of Participants
2541214|NCT03032510|Primary|Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the Test-Of-Cure (TOC) Visit|This was the co-primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to ertapenem in responder outcome, which was derived from both clinical and microbiological responses, in the micro-ITT population. Clinical responses were either cure, failure, or indeterminate/missing; microbiological responses were characterized programmatically as either success, failure, or indeterminate/missing. Clinical cure was defined as complete resolution or significant improvement of signs or symptoms of the infection; microbiological success was a reduction of the baseline pathogen(s) to <10^4 colony-forming units/milliliter (CFU/mL). An outcome of responder required a clinical response of cure and a microbiological response of success. Any other combination of the clinical and microbiological responses was considered either Non-responder or Indeterminate.|TOC visit (14-17 days after randomization)|micro-ITT included all participants in the ITT population who had at least 1 baseline bacterial pathogen from a urine or blood culture that caused a urinary tract infection (UTI) against which eravacycline and ertapenem had expected antibacterial activity.|||Participants|||Count of Participants
2541215|NCT03032510|Primary|Proportion of Participants in the Micro-ITT Population Demonstrating Clinical Cure and Microbiologic Success at the EOI Visit|This was the co-primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to ertapenem in responder outcome, which was derived from both clinical and microbiological responses, in the micro-ITT population. Clinical responses were either cure, failure, or indeterminate/missing; microbiological responses were characterized programmatically as either success, failure, or indeterminate/missing. Clinical cure was defined as complete resolution or significant improvement of signs or symptoms of the infection; microbiological success was a reduction of the baseline pathogen(s) to <10^4 colony-forming units/milliliter (CFU/mL). An outcome of Responder required a clinical response of cure and a microbiological response of success. Any other combination of the clinical and microbiological responses was considered either Non-responder or Indeterminate.|End of Infusion|micro-ITT included all participants in the ITT population who had at least 1 baseline bacterial pathogen from a urine or blood culture that caused a urinary tract infection (UTI) against which eravacycline and ertapenem had expected antibacterial activity.|||Participants|||Count of Participants
2541216|NCT03032263|Secondary|Incidence of Failed Nasal Intubation|The incidence of failed nasal intubation was recorded as the number of intubations that were not successful.|1 day||||number of intubations|||Number
2541217|NCT03032263|Secondary|Presence of Nasal Bleeding|Number of participants that experienced nasal bleeding was recorded.|1 day||||Participants|||Count of Participants
2541218|NCT03032263|Secondary|Grade of Larynx View|Larynx view is graded from 1-4 (1 is full glottis visible, 2 is only posterior commisure, 3 is only epiglottis visible, and 4 is no glottis structures are visible).|1 day||||units on a scale||Standard Deviation|Mean
2541219|NCT03032263|Secondary|Time to Intubation|Reported as the average time it took to intubate (seconds).|1 day||||seconds||Standard Deviation|Mean
2541221|NCT03031899|Secondary|Presence of Dysplasia in Biopsied Lesions That Were Stained by Rose Bengal|this outcome measure was limited to the biopsied lesions.additionally, the intent of this outcome measure was only to study early detection of dysplasia in oral premalignant lesions using the Rose bengal stain. (no comparison between the two stains were intended )|2 weeks||||lesions|lesions||Count of Units
2541222|NCT03031899|Primary|Sensitivity and Specificity (Percentage of True Positives and True Negatives)|sensitivity: Percentage of lesions stained positive with Toluidine blue stain that were also stained positive with Rose Bengal stain specificity: Percentage of lesions stained negative with Toluidine blue stain that were also stained negative with Rose Bengal stain|2 weeks||||percentage of lesions|lesions||Number
2541223|NCT03031899|Primary|Number and Percentage of Lesions That Were Stained Positive|outcome measure1|2 weeks|patients diagnosed with premalignant lesions who consented to participate in the study|||lesions|lesions||Count of Units
2541224|NCT03031795|Primary|Pain Before, During and After IUD Placement|Pain before, during and after IUD placement on a 0 (no pain) to 10 (worst possible) scale. Higher score mean a worse outcome.|Before, during and after IUD placement||||units on a scale||Standard Deviation|Mean
2541225|NCT03031496|Secondary|Body Temperature Values at Indicated Time Points|Vital sign measurements including body temperature were taken in a supine position after at least 5 minutes of rest at Day -1, Day 1, Day 2 and Day 3 in each treatment period. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day -1 and Day 3 of each treatment period|Safety Population|||Degree Celsius||Standard Deviation|Mean
2541226|NCT03031496|Secondary|Pulse Rate Values at Indicated Time Points|Vital sign measurements including pulse rate were taken in a supine position after at least 5 minutes of rest at Day -1, Day 1, Day 2 and Day 3 in each treatment period. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day -1 and Day 3 of each treatment period|Safety Population|||Beats per minute (bpm)||Standard Deviation|Mean
2541227|NCT03031496|Secondary|Respiratory Rate Values at Indicated Time Points|Vital sign measurements including respiratory rate were taken in a supine position after at least 5 minutes of rest at Day -1, Day 1, Day 2 and Day 3 in each treatment period. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day -1 and Day 3 of each treatment period|Safety Population|||Breaths per minute||Standard Deviation|Mean
2541228|NCT03031496|Secondary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Indicated Time Points|Vital sign measurements including SBP and DBP were taken in a supine position after at least 5 minutes of rest at Day -1, Day 1, Day 2 and Day 3 in each treatment period. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day -1 and Day 3 of each treatment period|Safety Population|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2541229|NCT03031496|Secondary|Total Protein Levels at Indicated Time Points|Serum total protein levels were assessed as a clinical chemistry laboratory parameter at Day -1 and Day 3 in each treatment period. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Day -1 and Day 3 of each treatment period|Safety Population|||Grams per liter (g/L)||Standard Deviation|Mean
2541230|NCT03031496|Secondary|Creatinine, Direct Bilirubin and Total Bilirubin Levels at Indicated Time Points|Serum creatinine, direct bilirubin and total bilirubin levels were assessed as a clinical chemistry laboratory parameter at Day -1 and Day 3 in each treatment period. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Day -1 and Day 3 of each treatment period|Safety Population|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2541231|NCT03031496|Secondary|Calcium, Chloride, Glucose, Magnesium, Potassium and Sodium Levels at Indicated Time Points|Serum calcium, chloride, glucose, magnesium, potassium and sodium levels were assessed as a clinical chemistry laboratory parameter at Day -1 and Day 3 in each treatment period. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Day -1 and Day 3 of each treatment period|Safety Population|||Millimoles per liter (Mmol/L)||Standard Deviation|Mean
2541232|NCT03031496|Secondary|Blood Urea Nitrogen (BUN) Levels at Indicated Time Points|Serum BUN levels were assessed as a clinical chemistry laboratory parameter at Day -1 and Day 3 in each treatment period. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Day -1 and Day 3 of each treatment period|Safety Population|||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2541233|NCT03031496|Secondary|Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.) and Aspartate Aminotransferase (AST) Levels at Indicated Time Points|Serum ALT, alk. phosph. and AST levels were assessed as a clinical chemistry laboratory parameter at Day -1 and Day 3 in each treatment period. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Day -1 and Day 3 of each treatment period|Safety Population|||Unit per liter (U/L)||Standard Deviation|Mean
2541234|NCT03031496|Secondary|Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) During Treatment Period|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. Only those participants with data available at the specified time points were analyzed|Up to 25 days|Safety Population comprised of all randomized participants who received at least 1 dose of study treatment.|||Participants|||Number
2541235|NCT03031496|Secondary|Terminal Phase Half-life (T1/2) of Hydrochlorothiazide and Amiloride Hydrochloride in Plasma|Blood samples were collected at indicated time points under fasting conditions for PK analysis of hydrochlorothiazide and amiloride. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose, 0.33, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12,14, 16 hours post-dose on Day 1, 24 and 36 hours post dose on Day 2 and 48 hours post-dose on Day 3|PK Population|||Hour||Full Range|Median
2541236|NCT03031496|Secondary|Percentage of AUC(0-inf) Obtained by Extrapolation (Percent AUCex) of Hydrochlorothiazide and Amiloride Hydrochloride in Plasma|Blood samples were collected at indicated time points under fasting conditions for PK analysis of hydrochlorothiazide and amiloride. Bioequivalence of test product and reference product was assessed based on the 90 percent CIs for estimates of the geometric mean ratios between percent AUCex of the test and reference products in relation to the conventional bioequivalence range. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose, 0.33, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12,14, 16 hours post-dose on Day 1, 24 and 36 hours post dose on Day 2 and 48 hours post-dose on Day 3|PK Population|||Percent of area||Geometric Coefficient of Variation|Geometric Mean
2541237|NCT03031496|Secondary|Time of Occurrence of Cmax (Tmax) of Hydrochlorothiazide and Amiloride Hydrochloride in Plasma|Blood samples were collected at indicated time points under fasting conditions for PK analysis of hydrochlorothiazide and amiloride. Median and full range has been presented.|Pre-dose, 0.33, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12,14, 16 hours post-dose on Day 1, 24 and 36 hours post dose on Day 2 and 48 hours post-dose on Day 3|PK Population|||Hour||Full Range|Median
2541238|NCT03031496|Secondary|AUC From Time Zero to Infinity (AUC[0-inf]) of Hydrochlorothiazide and Amiloride Hydrochloride in Plasma|Blood samples were collected at indicated time points under fasting conditions for PK analysis of hydrochlorothiazide and amiloride. Bioequivalence of test product and reference product was assessed based on the 90 percent CIs for estimates of the geometric mean ratios between the AUC (0-inf) of the test and reference products in relation to the conventional bioequivalence range. An analysis of variance was used with sequence, subject (sequence), treatment and period as fixed effects. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose, 0.33, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12,14, 16 hours post-dose on Day 1, 24 and 36 hours post dose on Day 2 and 48 hours post-dose on Day 3|PK Population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2541239|NCT03031496|Primary|Maximum Observed Concentration (Cmax) of Hydrochlorothiazide and Amiloride Hydrochloride in Plasma|Blood samples were collected at indicated time points under fasting conditions for pharmacokinetic (PK) analysis of hydrochlorothiazide and amiloride. Bioequivalence of test product and reference product was assessed based on the 90 percent CIs for estimates of the geometric mean ratios between the Cmax of the test and reference products in relation to the conventional bioequivalence range. An analysis of variance was used with sequence, subject (sequence), treatment and period as fixed effects.|Pre-dose, 0.33, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12,14, 16 hours post-dose on Day 1, 24 and 36 hours post dose on Day 2 and 48 hours post-dose on Day 3|PK Population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2541240|NCT03031496|Primary|Area Under the Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC [0-t]) of Hydrochlorothiazide and Amiloride Hydrochloride|Blood samples were collected at indicated time points under fasting conditions for pharmacokinetic (PK) analysis of hydrochlorothiazide and amiloride. Bioequivalence of test product and reference product was assessed based on the 90 percent confidence intervals (CIs) for estimates of the geometric mean ratios between the AUC (0-t) of the test and reference products in relation to the conventional bioequivalence range. An analysis of variance was used with sequence, subject (sequence), treatment and period as fixed effects.|Pre-dose, 0.33, 0.67, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10, 12,14, 16 hours post-dose on Day 1, 24 and 36 hours post dose on Day 2 and 48 hours post-dose on Day 3|PK Population comprised of All participants who completed the study and for whom primary PK parameters was calculated for all treatment periods.|||Hour x nanograms/milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2541241|NCT03031431|Secondary|Qualitative Survey|The same as primary outcome and secondary outcome as described above with the setting being clinic and transport based rather than in a hospital, and with the addition of qualitative questions for mother and nurse regarding infant warmer use.|Up to 1 year|Zero participants were analyzed as the investigators ultimately decided not collect qualitative data.||||||
2541242|NCT03031431|Secondary|Functionality|The functionality will be assessed by whether or not there appeared to be wear and tear on the infant warmer based on repeated use.|Up to 6 months||||infant warmers|Infant Warmers||Number
2541243|NCT03031431|Secondary|Usability|The investigators will use observation to evaluate the usability of the warmer by assessing whether or not the infant warmer was used in a way that deviated from its recommended use.|Up to 6 months||||Encounters with non-electric warmer|Encounters||Number
2541244|NCT03031431|Primary|Temperature/Effectiveness|The infant warmer will be evaluated on the number of time is able to successfully achieve and maintain a normal body temperature for patients who are hypothermic and those patients at risk of hypothermia because of a < 2.5 kg birth weight or < 35 week gestational age.|Up to 6 months||||Number of infant warmer uses|Encounters||Number
2541245|NCT03031340|Secondary|Anesthesia Satisfaction|To measure the level of overall anesthesia satisfaction among the two groups at discharge.|24 hours post surgery|Data not collected therefore no analysis||||||
2541246|NCT03031340|Secondary|Pre-operative Anxiety|Measure the level of pre-operative anxiety using the visual analog scale (VAS)|24 hours prior to surgery|Data not collected therefore no analysis||||||
2541247|NCT03031340|Secondary|Post Operative Cognitive Function|48 hours post operative headache, dizziness, sedation and blurred vision|48 hours|Data not collected therefore no analysis||||||
2541248|NCT03031340|Secondary|Incidence of 48 Hours Post Operative Nausea and Vomiting|Find the incidence of 48 hours post operative nausea and vomiting in the target population|48 hours|Data not collected therefore no analysis||||||
2541249|NCT03031340|Secondary|Pain Using the Visual Analog Scale (VAS) Pain Score|evaluate pain using the visual analog scale (VAS) pain score at two hrs post-op, the morning following surgery 24 hours and 48 hours post-op|2 hours, 24 hours, 48 hours|Data not collected therefore no analysis||||||
2541250|NCT03031340|Primary|Postoperative Opioid Requirement|The primary objective of this study is to evaluate the role of three doses of pregabalin on intra and postoperative (48hrs) opioid requirements in patients undergoing fusion of two or more vertebrae.|48 hours|Data not collected therefore no analysis||||||
2541255|NCT03030638|Secondary|Percentage of Off-label Use of Indacaterol Among New Users|Percentage of off-label use of Indacaterol among new users of this medication. Potential off-label are the patients, aged 18 years or older with no recorded COPD diagnosis and no asthma diagnosis. Off-label are the patients, aged 17 years or younger or patients aged 18 years or older with no recorded COPD diagnosis but with a diagnosis of asthma.|01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.|Study population|||Percentage of participants|||Number
2541256|NCT03030638|Primary|Percentage of Off-label Use of Olodaterol Among New Users|Percentage of off-label use of olodaterol among new users of this medication. Potential off-label are the patients, aged 18 years or older with no recorded Chronic Obstructive Pulmonary Disease (COPD) diagnosis and no asthma diagnosis. Off-label are the patients, aged 17 years or younger or patients aged 18 years or older with no recorded COPD diagnosis but with a diagnosis of asthma. Index date is defined as the date an eligible patient receives the first dispensing of olodaterol or indacaterol during the study period.|01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.|Study population|||Percentage of participants|||Number
2541257|NCT03030183|Secondary|Change-from-baseline Hemoglobinuria Values|Changes from baseline at each of the scheduled postbaseline time-points Hemoglobinuria was assessed using a urine colorimetric scoring system with a score of 1 through 10. Where 1 represents no hemoglobinuria and 10 represents maximum hemoglobinuria.|Through week 12|Efficacy Evaluable|||score on a scale||Standard Deviation|Mean
2541258|NCT03030183|Secondary|Change-from-baseline Reticulocyte Values|Changes from baseline at each of the scheduled postbaseline time-points|Through week 12|Efficacy Evaluable|||10^12 cells/L||Standard Deviation|Mean
2541259|NCT03030183|Secondary|Change-from-baseline Haptoglobin Values|Changes from baseline at each of the scheduled postbaseline time-points|Through week 12|Efficacy Evaluable|||g/L||Standard Deviation|Mean
2541260|NCT03030183|Secondary|Change-from-baseline Free Hemoglobin Values|Changes from baseline at each of the scheduled postbaseline time-points|Through week 12|Efficacy Evaluable|||mg/dL|||Number
2541261|NCT03030183|Secondary|Change-from-baseline Total Hemoglobin Values|Changes from baseline at each of the scheduled postbaseline time-points|Through week 12|Efficacy Evaluable|||g/L||Standard Deviation|Mean
2541262|NCT03030183|Secondary|Change-from-baseline Bilirubin Values|Changes from baseline at each of the scheduled postbaseline time-points|Through week 12|Efficacy Evaluable|||umol/L||Standard Deviation|Mean
2541263|NCT03030183|Primary|Change-from-baseline in Serum Lactate Dehydrogenase (LDH) Levels.|Change-from-baseline through Week 12 in serum lactate dehydrogenase (LDH) levels|Through Week 12 of the study|Efficacy Evaluable|||U/L||Standard Deviation|Mean
2541264|NCT03029988|Primary|Visualization of Lesions by FDG PET/CT Imaging and by Tc 99m Tilmanocept SPECT/CT Imaging.|The primary objectives of this study were to estimate the concordance of Tc 99m tilmanocept localization in liver metastases from colorectal carcinoma (CRC) using single photon emission computed tomography / computed tomography (SPECT/CT) imaging and abdominal fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) imaging per subject and to evaluate the safety including monitoring the incidence of adverse events and changes over time in laboratory tests, vital signs, and physical examination findings.|Within 7 days after Tc 99m tilmanocept administration||||Lesions|||Number
2541265|NCT03029832|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to MOXR0916 and Atezolizumab|ATAs may be produced by the body in response to an administered drug.|Cycles 1 - 4 and 8, 12, and 16 (each cycle is 21 days), Day 1: predose|Due to early termination, no formal analyses were performed for percentage of participants with ATAs to MOXR0916 and Atezolizumab.||||||
2541266|NCT03029832|Secondary|Clearance of MOXR0916 and Atezolizumab|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose|Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.||||||
2541267|NCT03029832|Secondary|Minimum Plasma Concentration (Cmin) of MOXR0916 and Atezolizumab|Cmin refers to the minimum (trough) serum concentration of a drug in a specified compartment or test area of the body.|Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose|Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.||||||
2541268|NCT03029832|Secondary|Maximum Plasma Concentration (Cmax) of MOXR0916 and Atezolizumab|Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose.|Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose|Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.||||||
2541269|NCT03029832|Secondary|Area Under the Plasma Drug Concentration-time Curve (AUC) of MOXR0916 and Atezolizumab|AUC represents the body's exposure to an administered drug.|Cycle 1 (each cycle is 21 days), Day 1: predose and 30 min. after atezolizumab infusion; Cycle 1, on Days 8 and 15. Cycles 2 4, Day 1: predose and 30 min. after atezolizumab infusion. Cycles 8, 12, and 16: predose|Due to early termination, no formal analyses were performed for any of the pharmacokinetic measures.||||||
2541270|NCT03029832|Secondary|Percentage of Participants With Adverse Event (AEs)|An adverse event is any untoward medical occurrence, regardless of causal attribution.|Up to approximately 45 months|The safety population was defined as all participants who have received at least one dose of study medication. Data were collected but are not being summarized due to privacy concerns with the low number of patients analyzed.||||||
2541287|NCT03029780|Secondary|Incidence Rate of All Causality Grade 3-5 AE|The all causality Grade 3 - 5 AE rate is defined as number of participants who experienced at least 1 AE of Grade 3 or higher with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment, divided by number of treated participants. Evaluated using the NCI CTCAE version 4.0 criteria|From the time of randomization to end of combination period (assessed up to November 24th, 2017, approximately 9 months)|All treated participants|||Percentage of Particpants||95% Confidence Interval|Number
2541271|NCT03029832|Secondary|Percentage of Participants Reporting Symptom Interference With Daily Living at the Time of Progression According to the MDASI|"The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is as bad as you can imagine or interfered completely with the participant's life."|Up to approximately 45 months|Due to early termination, no formal analyses were performed for percentage of participants reporting symptom interference with daily living at the time of progression according to the MDASI||||||
2541272|NCT03029832|Secondary|Time to Pain Progression, Pain Palliation, and Fatigue Progression as Measured by Participant-Reported Severity According to the M. D. Anderson Symptom Inventory (MDASI)|"The MDASI is a cancer-related, self-reported questionnaire consisting of 19 items assessing symptom severity and interference with different aspects of a participant's life. The MDASI items are rated from 0 to 10, with 0 indicating that the symptom is either not present or does not interfere with the participant's activities and 10 indicating that the symptom is as bad as you can imagine or interfered completely with the participant's life."|Up to approximately 45 months|Due to early termination, no formal analyses were performed for time to pain progression, pain palliation and fatigue progression.||||||
2541273|NCT03029832|Secondary|Duration of Objective Response (DOR) According to RECIST v1.1|DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1. Objective response is defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.|Up to approximately 45 months|Due to early termination, no formal analyses were performed for DOR.||||||
2541274|NCT03029832|Secondary|Objective Response (OR) According to RECIST v1.1|OR is defined as a complete response (CR) or partial response (PR) on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.|Up to approximately 45 months|Due to early termination, no formal analyses were performed for OR.||||||
2541275|NCT03029832|Primary|Overall Survival (OS)|Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death.|Up to approximately 45 months|Due to early termination, no formal analyses were performed for OS.||||||
2541276|NCT03029832|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline); and an absolute increase of >= 5 millimeter (mm) in the sum of diameters.|Up to approximately 45 months|Due to early termination, no formal analyses were performed for PFS.||||||
2541277|NCT03029819|Other Pre-specified|Self-reported Mindfulness and Psychological Functioning|Mindfulness, affect, self-efficacy, dependence, and withdrawal symptoms (questionnaire)|End of treatment (8 weeks)|||||||
2541278|NCT03029819|Other Pre-specified|Weekly Mindfulness Practice|Self-reported average weekly mindfulness practice (questionnaire)|Throughout treatment period (8 weeks)|||||||
2541279|NCT03029819|Other Pre-specified|Number of Cigarettes Smoked Per Day|Self-reported number of cigarettes smoked per day (questionnaire)|End of treatment (8 weeks)|||||||
2541280|NCT03029819|Secondary|Attrition|Number of participants who do not attend end-of-treatment session|End of treatment (8 weeks)||||Participants|||Count of Participants
2541281|NCT03029819|Secondary|Participant Ratings|"Perceived Text Message Helpfulness (minimum value 1 [not at all helpful], maximum value 10 [extremely helpful], higher scores mean better outcome)"|End of Treatment (8 weeks)|Only participants in the iQuit Mindfully condition were included in this analysis because those in MBAT did not receive text messages.|||units on a scale||Standard Deviation|Mean
2541282|NCT03029819|Secondary|Participant Engagement|Number of participants who respond to interactive text messages|Over the 8-week treatment period|Only participants in the iQuit Mindfully condition were included in this analysis because MBAT participants did not receive text messages.|||Participants|||Count of Participants
2541283|NCT03029819|Primary|Smoking Abstinence|Number of participants who abstained from smoking (based on self-reported 7-day abstinence, which is biochemically verified by expired carbon monoxide <6 parts per million (ppm)|End of Treatment (8 weeks)|Available data for smoking abstinence were analyzed because coding missing data as smoking can severely bias results. Accordingly, the overall number of participants analyzed for smoking abstinence was 55.|||Participants|||Count of Participants
2541284|NCT03029780|Secondary|Progression Free Survival (PFS)|PFS is defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first|From the date of first dose to end of combination stage approximately 9 months|||||||
2541285|NCT03029780|Secondary|Objective Response Rate (ORR)|The ORR is defined as the number of participants with a BOR of CR or PR divided by the number of treated participants. The BOR is defined as the best response designation, as determined by the investigator, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of first subsequent anti-cancer therapy including radiotherapy, tumor-directed surgery, or systemic anticancer therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR assessment|From the date of first dose to end of combination stage approximately 9 months|||||||
2541286|NCT03029780|Secondary|Nivolumab and Ipilimumab Geometric Mean Concentrations at End of Infusion (EOI) and Predose at Cycle 1, 2 and 4|To determine pharmacokinetics (PK) comparisons of Nivolumab and Ipilimumab administered as FRC to that of sequentially administered Nivolumab and Ipilimumab. PK will be measured using serum concentration-time data.|From the date of first dose to end of combination stage approximately 9 months|||||||
2541288|NCT03029780|Secondary|Incidence Rate of Drug Related Grade 3-5 AEs.|The drug-related Grade 3 - 5 AE rate is defined as number of participants who experienced at least 1 AE of Grade 3 or higher, judged to be related to study treatment by the investigator, with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment, divided by number of treated participants. Evaluated using Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria.|From the time of randomization to end of combination period (assessed up to November 24th, 2017, approximately 9 months)|All treated participants|||Percentage of Participants||95% Confidence Interval|Number
2541289|NCT03029780|Secondary|Incidence Rate of AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ Occurring Within 2 Days After Any Dose in the Part 1 Period|This incidence rate is defined similarly to the primary endpoint except that the event rate will be based on terms within the narrow scope SMQ rather than the broad scope.|From the time of randomization to end of combination period (assessed up to November 24th, 2017, approximately 9 months)|All treated participants|||Percentage of Participants||95% Confidence Interval|Number
2541290|NCT03029780|Primary|Incidence Rate of Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction SMQ Within 2 Days After Any Dose in Combination Period.|This incidence rate is defined as the number of participants who experienced at least 1 AE in the MedDRA Anaphylactic Reaction broad scope SMQ with onset on the day of or within 2 days after any study therapy infusion during the combination period (Part 1) divided by number of treated participants.|From the time of randomization to end of combination period (assessed up to November 24th, 2017, approximately 9 months)|All treated participants|||Percentage of Participants||95% Confidence Interval|Number
2541291|NCT03029650|Secondary|Residual Drug Analysis in Worn TDDS|This will be done in the TDDS after its removal to estimate total amount of absorbed scopolamine.|3 - 6 months||||% residual drug recovery||Standard Deviation|Mean
2541292|NCT03029650|Secondary|Determination of Area Under the Serum Concentration-time Curve (AUC)||Measured at time points:1,2,3,4,5,6,8,10,12,24,36,48,60,72,73,74,78,84,96,108,120 hours during Intervention: Transderm Scop® and at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36, and 48 hours during Intervention: scopolamine HBr||||ng*hr/ml||Standard Deviation|Mean
2541293|NCT03029650|Secondary|Measurement of Time of Maximum Serum Scopolamine Concentration (Tmax)||Measured at time points: pre-dose, 1,2,3,4,5,6,8,10,12,24,36,48,60, and 72 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr||||hr||Standard Deviation|Mean
2541294|NCT03029650|Secondary|Measurement of Elimination Rate Constant of Scopolamine (Kel)||Measured at time points: 73,74,78,84,96,108,120 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr||||1/hr||Standard Deviation|Mean
2541295|NCT03029650|Secondary|Measurement of Volume of Scopolamine Distribution (V)|This measure is only analyzed for the IV scopolamine HBr arm of the study.|Measured at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36,48 hours during Intervention: scopolamine HBr||||L||Standard Deviation|Mean
2541296|NCT03029650|Secondary|Assessment of Scopolamine Clearance (CL)|This will be done only after the IV is administered to estimate the rate of removal of scopolamine from the body. Will not be measured during patch arm.|Measured at time points: 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12,24,36,48 hours during Intervention: scopolamine HBr||||L/hr||Standard Deviation|Mean
2541297|NCT03029650|Primary|Measurement of Maximum Serum Concentration of Scopolamine (Cmax)||Measured at time points: pre-dose, 1,2,3,4,5,6,8,10,12,24,36,48,60, and 72 hours during Intervention: Transderm Scop® and at time points: pre-dose, 2.5,5,10,20,30,45 minutes, 1.5,2,3,4,5,6,8,10,12 hours during Intervention: scopolamine HBr|The number of participants analyzed represents the total number of participants that completed both interventions.|||ng/ml||Standard Deviation|Mean
2541298|NCT03029234|Secondary|Mean Residence Time Observed From Time Zero to the Last Quantifiable Concentration (MRTlast) for Carfilzomib|MRTlast is the mean residence time observed from time 0 until the time of the last quantifiable concentration.|Cycles 1 and 2, day 1 at predose, 5 minutes after the start of carfilzomib infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of infusion.|PK analyses were conducted on a subset of participants at selected sites. Results are reported for the participants in PK analysis population with available data at each time point. PK profiles with a coefficient of determination < 0.8, percent extrapolated AUC > 20%, or negative values for MRT were excluded from the analysis.|||hours||Standard Deviation|Mean
2541299|NCT03029234|Secondary|Volume of Distribution at Steady State (Vss) for Carfilzomib|Volume of distribution at steady-state is a pharmacokinetic parameter that relates the amount of drug in the body at steady-state to the concentration of drug in the plasma.|Cycles 1 and 2, day 1 at predose, 5 minutes after the start of carfilzomib infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of infusion.|PK analyses were conducted on a subset of participants at selected sites. Results are reported for participants in the PK analysis population with available data at each time point. PK profiles with a coefficient of determination < 0.8, percent extrapolated AUC > 20%, or negative values for Vss were excluded from the analysis.|||liters||Standard Deviation|Mean
2541300|NCT03029234|Secondary|Volume of Distribution (Varea) of Carfilzomib|Volume of distribution is a pharmacokinetic parameter relating the amount of drug in the body to the concentration of drug in plasma.|Cycles 1 and 2, day 1 at predose, 5 minutes after the start of carfilzomib infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of infusion.|Pharmacokinetic analyses were conducted on a subset of participants at selected sites. Results are reported for participants in the PK analysis population with available data at each time point. PK profiles with a coefficient of determination (R²; goodness of fit) < 0.8 or percent extrapolated AUC > 20% were excluded from the analysis.|||Liters||Standard Deviation|Mean
2541324|NCT03029000|Secondary|Number of Aphereses Necessary to Collect at Least 5*10^6 CD34+ Cells/kg of Recipient Body Weight|The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.|Days 5 to 8|Participants who received 5-day regimen of tbo-filgrastim 10 mcg/kg of body weight; and for whom, Day 5 apheresis was performed as planned and a quantifiable count of CD34+ cells in blood collected in Day 5 apheresis was measured.|||aphereses|||Number
2541301|NCT03029234|Secondary|Systemic Clearance (CL) of Carfilzomib After Intravenous Infusion|Systemic clearance is a measure of the ability of the body to eliminate drug, expressed in units of volume per time.|Cycles 1 and 2, day 1 at predose, 5 minutes after the start of carfilzomib infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of infusion.|Pharmacokinetic analyses were conducted on a subset of participants at selected sites. Results are reported for participants in the PK analysis population with available data at each time point. PK profiles with a coefficient of determination (R²; goodness of fit) < 0.8 or percent extrapolated AUC > 20% were excluded from the analysis.|||L/hr||Standard Deviation|Mean
2541302|NCT03029234|Secondary|Terminal Elimination Half-Life (T½) for Carfilzomib|The terminal elimination half-life is the time required for plasma concentrations to fall by 50% in the terminal phase of the concentration-time profile.|Cycles 1 and 2, day 1 at predose, 5 minutes after the start of carfilzomib infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of infusion.|Pharmacokinetic analyses were conducted on a subset of participants at selected sites. Results are reported for participants in the PK analysis population with available data at each time point. PK profiles with a coefficient of determination (R²; goodness of fit) < 0.8 or percent extrapolated AUC > 20% were excluded from the analysis.|||hours||Standard Deviation|Mean
2541303|NCT03029234|Secondary|Area Under the Plasma Concentration Curve From Time 0 Extrapolated to Infinity (AUC0-inf) for Carfilzomib|AUC0-inf of carfilzomib is the total area under the concentration-time curve beginning from time 0 extrapolated to infinity following carfilzomib dosing.|Cycles 1 and 2, day 1 at predose, 5 minutes after the start of carfilzomib infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of infusion.|Pharmacokinetic analyses were conducted on a subset of participants at selected sites. Results are reported for participants in the PK analysis population with available data at each time point. PK profiles with a coefficient of determination (R²; goodness of fit) < 0.8 or percent extrapolated AUC > 20% were excluded from the analysis.|||hr*ng/mL||Standard Deviation|Mean
2541304|NCT03029234|Secondary|Area Under the Plasma Concentration Curve From Time 0 to the Last Measurable Concentration (AUClast) for Carfilzomib|AUClast of carfilzomib is the total area under the concentration-time curve beginning from time 0 to the time of the last measurable concentration of carfilzomib.|Cycles 1 and 2, day 1 at predose, 5 minutes after the start of carfilzomib infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of infusion.|Pharmacokinetic (PK) analyses were conducted on a subset of participants at selected sites. The PK analysis population included participants who received at least 1 dose of carfilzomib and had adequate data for the noncompartmental estimation of PK parameters. Results are reported for participants with available data at each time point.|||hr*ng/mL||Standard Deviation|Mean
2541305|NCT03029234|Secondary|Time to Maximum Plasma Concentration (Tmax) of Carfilzomib|Tmax of carfilzomib is the time at which maximum observed plasma concentrations of carfilzomib were observed.|Cycles 1 and 2, day 1 at predose, 5 minutes after the start of carfilzomib infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of infusion.|Pharmacokinetic (PK) analyses were conducted on a subset of participants at selected sites. The PK analysis population included participants who received at least 1 dose of carfilzomib and had adequate data for the noncompartmental estimation of PK parameters. Results are reported for participants with available data at each time point.|||hours||Full Range|Median
2541306|NCT03029234|Secondary|Maximum Observed Plasma Concentration (Cmax) of Carfilzomib|Cmax is the maximum observed plasma concentration over the concentration-time profile of carfilzomib.|Cycles 1 and 2, day 1 at predose, 5 minutes after the start of carfilzomib infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of infusion.|Pharmacokinetic (PK) analyses were conducted on a subset of participants at selected sites. The PK analysis population included participants who received at least 1 dose of carfilzomib and had adequate data for the noncompartmental estimation of PK parameters. Results are reported for participants with available data at each time point.|||ng/mL||Standard Deviation|Mean
2541307|NCT03029234|Secondary|Time to Response (TTR)|Time to response (TTR) is the time from the first dose of any study treatment to the first confirmed response (PR or better) based on both investigator and independent review committee response assessments.|Response was assessed every 28 days until disease progression; the data cut-off date was 15 March 2019; median follow-up time for progression assessed by independent review committee and by investigators were 12.8 months and 13.1 months, respectively.|Safety population participants who achieved an overall response (best response of PR or better)|||months||Full Range|Median
2541308|NCT03029234|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from the first dose of any study treatment to the date of death due to any cause. Overall survival was analyzed using the Kaplan-Meier method; participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at their date of last contact (last known to be alive).|From first dose until the data cut-off date of 15 March 2019; median time on follow-up for survival was 15.3 months.|Safety population|||months||95% Confidence Interval|Median
2541309|NCT03029234|Secondary|Progression-free Survival (PFS)|"Progression-free survival (PFS) is defined as the time from first dose of any study treatment to the earlier of disease progression or death due to any cause according to the IMWG-URC criteria. PFS was analyzed using the Kaplan-Meier method; participants with no disease progression or death at the time of the data cut-off date were censored at the date of their last disease assessment; participants who started new anti-cancer therapy before disease progression or death were censored at their last disease assessment prior to starting new anti-cancer therapy.~Progression-free survival was determined based on both investigator and independent review committee response assessments."|Response was assessed every 28 days until disease progression; the data cut-off date was 15 March 2019; median follow-up time for progression assessed by independent review committee and by investigators were 12.8 months and 13.1 months, respectively.|Safety population|||months||95% Confidence Interval|Median
2541353|NCT03028870|Primary|"Daily Average Pain Over the Last 24 Hours Score at Week 4"|At week 4, subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.|Week 4|The full analysis population (FAP) (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.|||score on a scale||Standard Error|Mean
2541310|NCT03029234|Secondary|Duration of Clinical Benefit (DCB)|"Duration of clinical benefit (DCB) is defined as the time from first evidence of MR or better to disease progression or death due to any cause based on the (IMWG-URC criteria. DCB was estimated using the Kaplan-Meier method; participants with no disease progression or death at the analysis cut-off date were censored at their last disease assessment date.~Duration of clinical benefit was determined based on both investigator and independent review committee response assessments."|Response was assessed every 28 days until disease progression; the data cut-off date was 15 March 2019; median follow-up time for progression assessed by independent review committee and by investigators were 12.8 months and 13.1 months, respectively.|Safety population participants who achieved a best overall response of minimal response or better.|||months||95% Confidence Interval|Median
2541311|NCT03029234|Secondary|Duration of Overall Response (DOR)|"Duration of response (DOR) is defined as the time from first evidence of PR or better to disease progression (PD) or death due to any cause per the IMWG-URC criteria.~PD:~Increase of 25% from lowest response value in any of the following:~Serum M-component (absolute increase ≥ 0.5 g/dL) and/or~Urine M-component (absolute increase ≥ 200 mg/24 hours)~In patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL)~Definite development of new or increase in size of existing bone lesions or soft tissue plasmacytomas~Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.~DOR was analyzed using the Kaplan-Meier method; Participants with no documented progression or death were censored at the date of their last disease assessment.~DOR was determined based on both investigator and independent review committee response assessments."|Response was assessed every 28 days until disease progression; the data cut-off date was 15 March 2019; median follow-up time for progression assessed by independent review committee and by investigators were 12.8 months and 13.1 months, respectively.|Safety population participants who achieved an overall response (best response of PR or better)|||months||95% Confidence Interval|Median
2541312|NCT03029234|Secondary|Clinical Benefit Rate After at Least 12 Cycles of Treatment Assessed by the Investigator|"Clinical benefit rate (CBR) is defined as the percentage of participants with the best overall response of minimal response (MR) or better according to IMWG-URC criteria (i.e., a minimal response, partial response, very good partial response, complete response, or stringent complete response).~MR: 25% to 49% reduction in the level of serum M-protein and a 50% to 89% reduction in 24-hour urinary M-protein, which still exceeds 200 mg /24 hour; If present at baseline, a >50% reduction in the size of soft tissue plasmacytomas was also required."|se was assessed every 28 days until disease progression; CBR was analyzed after all participants received at least 12 cycles or had discontinued treatment; the data cut-off date was 15 March 2019; median follow-up time for progression was 13.1 months.|Safety population|||percentage of participants||95% Confidence Interval|Number
2541313|NCT03029234|Secondary|Clinical Benefit Rate After at Least 12 Cycles of Treatment Assessed by the Independent Review Committee|"Clinical benefit rate (CBR) is defined as the percentage of participants with the best overall response of minimal response (MR) or better according to IMWG-URC criteria (i.e., a minimal response, partial response, very good partial response, complete response, or stringent complete response).~MR: 25% to 49% reduction in the level of serum M-protein and a 50% to 89% reduction in 24-hour urinary M-protein, which still exceeds 200 mg /24 hour; If present at baseline, a >50% reduction in the size of soft tissue plasmacytomas was also required."|Response was assessed every 28 days until disease progression; CBR was analyzed after all participants received at least 12 cycles or discontinued treatment; the data cut-off date was 15 March 2019; median follow-up time for progression was 12.8 months.|Safety population|||percentage of participants||95% Confidence Interval|Number
2541314|NCT03029234|Secondary|Clinical Benefit Rate After at Least 6 Cycles of Treatment Assessed by the Investigator|"Clinical benefit rate (CBR) is defined as the percentage of participants with the best overall response of minimal response (MR) or better according to IMWG-URC criteria (i.e., a minimal response, partial response, very good partial response, complete response, or stringent complete response).~MR: 25% to 49% reduction in the level of serum M-protein and a 50% to 89% reduction in 24-hour urinary M-protein, which still exceeds 200 mg /24 hour; If present at baseline, a >50% reduction in the size of soft tissue plasmacytomas was also required."|Response was assessed every 28 days until disease progression; CBR was analyzed after all participants received at least 6 cycles or discontinued treatment; the data cut-off date was 05 November 2018; median follow-up time for progression was 10.3 months.|Safety population|||percentage of participants||95% Confidence Interval|Number
2541315|NCT03029234|Secondary|Clinical Benefit Rate After at Least 6 Cycles of Treatment Assessed by the Independent Review Committee|"Clinical benefit rate (CBR) is defined as the percentage of participants with the best overall response of minimal response (MR) or better according to International Myeloma Working Group Uniform Response Criteria (IMWG-URC) (i.e., a minimal response, partial response, very good partial response, complete response, or stringent complete response).~MR: 25% to 49% reduction in the level of serum M-protein and a 50% to 89% reduction in 24-hour urinary M-protein, which still exceeds 200 mg /24 hour; If present at baseline, a >50% reduction in the size of soft tissue plasmacytomas is also required"|Response was assessed every 28 days until disease progression; CBR was analyzed after all participants received at least 6 cycles or discontinued treatment; the data cut-off date was 05 November 2018; median follow-up time for progression was 8.9 months.|Safety population|||percentage of participants||95% Confidence Interval|Number
2541323|NCT03029000|Secondary|Percentage of Participants With Adverse Events (AEs)|A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs presented here included both SAEs and non-serious AEs.|From first administration of study drug (Day 1) up to early termination/end of study (up to approximately 3 months)|Safety analysis set included all participants who received at least 1 dose of tbo-filgrastim.|||percentage of particicpants|||Number
2541396|NCT03026803|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 2 years||||percentage of participants|||Number
2541316|NCT03029234|Secondary|Overall Response Rate After at Least 12 Cycles of Treatment Assessed by the Investigator|"ORR is defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR), or stringent CR (sCR) based on the International Myeloma Working Group Uniform Response Criteria.~sCR: As for CR, and absence of clonal plasma cells in bone marrow (BM). CR: No immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and < 5% plasma cells in BM. Normal serum free light chain (SFLC) ratio if disease measurable only by SFLC.~VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% decrease in serum M-protein with urine M-protein <100 mg/24 hrs. If disease measurable only by SFLC, ≥ 90% decrease in the difference between involved and uninvolved FLC levels (dFLC).~PR: ≥ 50% reduction of serum M-protein and ≥ 90% reduction in urine M-protein or to < 200 mg/24 hrs, or a ≥ 50% decrease in dFLC. A ≥ 50% decrease in the size of soft tissue plasmacytomas present at baseline."|Response was assessed every 28 days until disease progression; ORR was analyzed after all participants received at least 12 cycles or discontinued treatment; the data cut-off date was 15 March 2019; median follow-up time for progression was 13.1 months.|Safety population|||percentage of participants||95% Confidence Interval|Number
2541317|NCT03029234|Secondary|Overall Response Rate After at Least 12 Cycles of Treatment Assessed by the Independent Review Committee|"ORR is defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR), or stringent CR (sCR) based on the International Myeloma Working Group Uniform Response Criteria.~sCR: As for CR, and absence of clonal plasma cells in bone marrow (BM). CR: No immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and < 5% plasma cells in BM. Normal serum free light chain (SFLC) ratio if disease measurable only by SFLC.~VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% decrease in serum M-protein with urine M-protein <100 mg/24 hrs. If disease measurable only by SFLC, ≥ 90% decrease in the difference between involved and uninvolved FLC levels (dFLC).~PR: ≥ 50% reduction of serum M-protein and ≥ 90% reduction in urine M-protein or to < 200 mg/24 hrs, or a ≥ 50% decrease in dFLC. A ≥ 50% decrease in the size of soft tissue plasmacytomas present at baseline."|Response was assessed every 28 days until disease progression; ORR was analyzed after all participants received at least 12 cycles or discontinued treatment; the data cut-off date was 15 March 2019; median follow-up time for progression was 12.8 months.|Safety population|||percentage of participants||95% Confidence Interval|Number
2541318|NCT03029234|Secondary|Overall Response Rate (ORR) After at Least 6 Cycles of Treatment Assessed by the Investigator|"ORR is defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR), or stringent CR (sCR) based on the International Myeloma Working Group Uniform Response Criteria.~sCR: As for CR, and absence of clonal plasma cells in bone marrow (BM). CR: No immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and < 5% plasma cells in BM. Normal serum free light chain (SFLC) ratio if disease measurable only by SFLC.~VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% decrease in serum M-protein with urine M-protein <100 mg/24 hrs. If disease measurable only by SFLC, ≥ 90% decrease in the difference between involved and uninvolved FLC levels (dFLC).~PR: ≥ 50% reduction of serum M-protein and ≥ 90% reduction in urine M-protein or to < 200 mg/24 hrs, or a ≥ 50% decrease in dFLC. A ≥ 50% decrease in the size of soft tissue plasmacytomas present at baseline."|Response was assessed every 28 days until disease progression; ORR was analyzed after all participants received at least 6 cycles or discontinued treatment; the data cut-off date was 05 November 2018; median follow-up time for progression was 10.3 months.|Safety population|||percentage of participants||95% Confidence Interval|Number
2541319|NCT03029234|Primary|Overall Response Rate (ORR) After at Least 6 Cycles of Treatment Assessed by the Independent Review Committee|"ORR is defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR), or stringent CR (sCR) based on the International Myeloma Working Group Uniform Response Criteria.~sCR: As for CR, and absence of clonal plasma cells in bone marrow (BM). CR: No immunofixation on serum and urine, disappearance of soft tissue plasmacytomas and < 5% plasma cells in BM. Normal serum free light chain (SFLC) ratio if disease measurable only by SFLC.~VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% decrease in serum M-protein with urine M-protein <100 mg/24 hrs. If disease measurable only by SFLC, ≥ 90% decrease in the difference between involved and uninvolved FLC levels (dFLC).~PR: ≥ 50% reduction of serum M-protein and ≥ 90% reduction in urine M-protein or to < 200 mg/24 hrs, or a ≥ 50% decrease in dFLC. A ≥ 50% decrease in the size of soft tissue plasmacytomas present at baseline."|Response was assessed every 28 days until disease progression; ORR was analyzed after all participants received at least 6 cycles or discontinued treatment; the data cut-off date was 5 November 2018; median follow-up time for progression was 8.9 months.|Safety population|||percentage of participants||95% Confidence Interval|Number
2541320|NCT03029000|Secondary|Maximum Observed Peripheral CD34+ Cell Count (CD34+Cmax)|Serial blood samples for the determination of CD34+ cell count were drawn.|Between Day 1 (pre-dose) and before the first apheresis on Day 5|Pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of tbo-filgrastim and had at least 1 calculated PD parameter.|||cells per microliter (cells/mcL)|||Number
2541321|NCT03029000|Secondary|Maximum Observed Serum Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor (r-metHuG-CSF) Concentration (Cmax)|Blood samples were drawn for all participants for the determination of serum r-metHuG-CSF concentrations on Day 4. Pharmacokinetic (PK) parameter was calculated from concentration-time data using non compartmental methods, when possible.|Day 4 (8 hours post-dose)|PK analysis set included all participants who received at least 1 dose of tbo-filgrastim and had at least 1 calculated PK parameter for tbo-filgrastim.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
2541322|NCT03029000|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA)|Blood samples (5 milliliters [mL]) for analysis of ADA were obtained for all participants at timepoints described.|Baseline (Day -3) up to early termination/end of study (up to approximately 3 months)|Safety analysis set included all participants who received at least 1 dose of tbo-filgrastim.|||percentage of participants|||Number
2541415|NCT03026088|Secondary|Number of Participants With All Cause Mortality, Cardiac Death, or Re-admission Due to Heart Failure|Number of participants with all-cause mortality, cardiac death, or re-admission due to heart failure was reported.|Up to Week 26|The safety population included all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2541325|NCT03029000|Secondary|Percentage of Participants With at Least 5*10^6 CD34+ Cells/kg of Recipient Body Weight Collected After the First Apheresis on Day 5|The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.|Day 5|Participants who received 5-day regimen of tbo-filgrastim 10 mcg/kg of body weight; and for whom, Day 5 apheresis was performed as planned and a quantifiable count of CD34+ cells in blood collected in Day 5 apheresis was measured.|||percentage of participants|||Number
2541326|NCT03029000|Secondary|Percentage of Participants With at Least 2*10^6 CD34+ Cells/kg of Donor Baseline Body Weight Collected After the First Apheresis on Day 5|The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.|Day 5|Participants who received 5-day regimen of tbo-filgrastim 10 mcg/kg of body weight; and for whom, Day 5 apheresis was performed as planned and a quantifiable count of CD34+ cells in blood collected in Day 5 apheresis was measured.|||percentage of participants|||Number
2541327|NCT03029000|Primary|Percentage of Participants With at Least 2*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg) of Recipient Body Weight Collected in the First Apheresis on Day 5|The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.|Day 5|Participants who received 5-day regimen of tbo-filgrastim 10 mcg/kg of body weight; and for whom, Day 5 apheresis was performed as planned and a quantifiable count of CD34+ cells in blood collected in Day 5 apheresis was measured.|||percentage of participants|||Number
2541328|NCT03028987|Secondary|Number of Participants With Related Adverse Events|Number of individual twins who experienced related adverse events through the course of the study.|Day 0 to 28 post-immunization||||Participants|||Count of Participants
2541329|NCT03028987|Primary|Number of Participants Who Received Influenza Vaccine|Number of individual twins who received either LAIV or IIV4 as dictated by their group assignment|Day 0||||Participants|||Count of Participants
2541330|NCT03028974|Secondary|Count of Participants With Related Adverse Events||Day 0 to 28-32 post-immunization||||Participants|||Count of Participants
2541331|NCT03028974|Primary|Count of Participants From Each Arm Who Received Influenza Vaccine||Day 0 to 28-32 post immunization|Participants with available data at the respective timepoint are included in the analysis.|||Participants|||Count of Participants
2541332|NCT03028896|Secondary|Number of Blood Staining on the Laryngeal Mask Airway|post operative blood staining on the laryngeal mask airway|post op 1min||||Participants|||Count of Participants
2541333|NCT03028896|Secondary|Oropharyngeal Leak Pressure|audible leak during manual ventilation at mouth|at induction||||cmH2O||Standard Deviation|Mean
2541334|NCT03028896|Secondary|Insertion Time|time from passed mouth of the device to the effective ventilation after inflation of the cuff|at induction||||seconds||Standard Deviation|Mean
2541335|NCT03028896|Primary|First Attempt Success Rate|the first attempt success rate of insertion of LMA FlexibleTM|at induction||||Participants|||Count of Participants
2541336|NCT03028870|Secondary|Change From Baseline to Week 4 in Hospital Anxiety and Depression Scale (HADS) Score|Safety assessment to evaluate the impact of V120083 on mood (anxiety [HADS-A] and depression [HADS-D]). The score for each subscale ranges from 0 (no anxiety or depression) to 21, with a score of 11 or higher indicating the probable presence of the mood disorder.|Week 4|The safety population (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug.|||score on a scale||Standard Error|Mean
2541337|NCT03028870|Secondary|Number of Participants With Treatment-emergent Suicidal Ideation and Behaviors Assessed by Columbia-Suicide Severity Rating Score (C-SSRS)|Suicidality was monitored throughout the study using the C-SSRS. The C-SSRS involves a series of probing questions to inquire about possible suicidal thinking and behavior. The composite endpoints (Suicidal Ideation, Suicidal Behavior, Suicidal Ideation or Behavior) included subjects who experienced any one of the events at least once during treatment.|Baseline up to 4 Weeks|The safety population (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug.|||Participants|||Count of Participants
2541338|NCT03028870|Secondary|Supplemental Analgesic Medication Use|The average daily number of tablets of supplemental pain medication used during the double-blind period was summarized by treatment group.|Up to 28 days|The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.|||Supplemental Analgesic Tablets||Standard Error|Mean
2541339|NCT03028870|Secondary|Patient Global Impression of Change (PGIC)|"The PGIC is an ordinal scale which assesses the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse), where 1 = very much improved and 7 = very much worse. The number of subjects responding very much improved and much improved was summarized by treatment group."|4 Weeks|The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.|||Participants|||Count of Participants
2541340|NCT03028870|Secondary|European Quality of Life Scale - 5 Dimensions (EQ-5D-5L) to Measure Health Status|"EQ-5D-5L is a standardized generic measure of health status for clinical and economic appraisal based on a descriptive system that defines health in terms of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It includes a visual analogue scale (VAS) with scores ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)."|4 Weeks|The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.|||score on a scale||Standard Error|Mean
2541341|NCT03028870|Secondary|Medical Outcomes Study Short Form-36 (SF-36) - Mental Component Summary|"The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).~The Mental Component Summary is derived from 4 of the 8 health dimensions,(aggregate of VT, SF, RE, and MH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state."|4 Weeks|The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.|||score on a scale||Standard Error|Mean
2541342|NCT03028870|Secondary|Medical Outcomes Study Short Form-36 (SF-36) - Physical Component Summary|"The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH).~The Physical Component Summary is derived from 4 of the 8 health dimensions (aggregate of PF, RP, BP, and GH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state."|4 Weeks|The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.|||score on a scale||Standard Error|Mean
2541343|NCT03028870|Secondary|"Responder to Treatment (Calculated as the Percentage Reduction of Average Pain Over the Last 24 Hours) at Week 4"|"A subject's response to treatment was defined as the percentage reduction from the baseline average pain over the last 24 hours score to the week 4 pain score from the mBPI-SF pain severity subscale. Responders were defined as having > 0 % reduction; non-responders were defined as having ≤ 0% reduction."|Week 4|The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.|||Participants|||Count of Participants
2541344|NCT03028870|Secondary|Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Interference Subscale Score|The mBPI-SF is a self-administered questionnaire. The pain interference subscale of the mBPI-SF consists of Question 6 which has 7 parts, all of which ask the subjects to rate the impact/interference of their pain on various functions, ie, general activity, mood, walking, normal work, relations with others, sleep, and enjoyment of life on a 0 to 10 NRS where 0 = does not interfere and 10 = completely interferes. The mean interference of pain scores could range from 0 to 10.|4 Weeks|The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.|||score on a scale||Standard Error|Mean
2541345|NCT03028870|Secondary|Modified Brief Pain Inventory-Short Form (mBPI-SF) Pain Severity Subscale Score|The mBPI-SF is a self-administered questionnaire. The pain severity subscale of the mBPI-SF consists of 4 questions which ask the subjects to rate their severity of pain on a 0 to 10 NRS for worst pain, least pain, average pain, and current pain. The severity of pain was computed as the mean of questions 1-4. The mean severity of pain scores could range from 0 to 10.|4 Weeks|The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.|||score on a scale||Standard Error|Mean
2541346|NCT03028870|Secondary|Modified Brief Pain Inventory-Short Form (mBPI-SF) - Total Score (All Parts of 6 Questions)|The mBPI-SF consists of 6 questions and is a self-administered questionnaire used to assess the severity of pain, and the interference of pain on daily functions. Subjects rated their severity of pain / interference of pain on a 0 (no pain / does not interfere) to 10 (as bad as you can imagine / completely interferes) numerical rating scale (NRS) The total score is the sum of all parts of the 6 questions and the total score range is 0 - 110.|4 Weeks|The FAP (N = 291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.|||score on a scale||Standard Error|Mean
2541347|NCT03028870|Secondary|Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Total Score|The total score of the WOMAC consisted of 24 items (5 items from the pain subscale, 2 items from the stiffness subscale, and 17 items from the physical function subscale). The total score was obtained by adding the scores from these 3 subscales and could range from 0 to 96.|4 Weeks|The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.|||score on a scale||Standard Error|Mean
2541348|NCT03028870|Secondary|Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Physical Function Subscale|The physical function subscale consisted of 17 items: descending stairs; ascending stairs; rising from sitting; standing; bending to floor; walking on flat surface; getting into or out of car; going shopping; putting on socks; rising from bed; taking off socks; lying in bed; sitting; getting into or out of the bathtub; getting on or off the toilet; heavy domestic duties; light domestic duties. The score for each item ranged from 0 (none) to 4 (extreme) and the physical function subscale score was obtained by adding the responses to the 17 items which could range from 0 to 68.|4 Weeks|The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.|||score on a scale||Standard Error|Mean
2541349|NCT03028870|Secondary|Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Stiffness Subscale|The stiffness subscale consisted of 2 items; morning stiffness and stiffness occurring later in the day. The score for each item ranged from 0 (none) to 4 (extreme) and the stiffness subscale score was obtained by adding the responses to the 2 items which could range from 0 - 8.|4 Weeks|The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.|||score on a scale||Standard Error|Mean
2541350|NCT03028870|Secondary|Western Ontario and McMaster Osteoarthritis Index (WOMAC) - Pain Subscale|The pain subscale consisted of 5 items: walking; stair climbing; nocturnal; at rest; weight bearing. The score for each item ranged from 0 (none) to 4 (extreme). The pain subscale score was obtained by adding the responses to the 5 items which could range from 0 to 20.|4 Weeks|The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.|||score on a scale||Standard Error|Mean
2541351|NCT03028870|Secondary|"Average Daily Pain Right Now Score Collected by e-Diary"|Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.|4 Weeks|The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.|||score on a scale||Standard Error|Mean
2541352|NCT03028870|Secondary|"Weekly Change From Baseline Score of Average Pain Over the Last 24 Hours From the mBPI-SF Pain Severity Subscale"|Subjects were asked to rate their pain on an 11-point numerical scale where 0 = no pain, 10 = pain as bad as you can imagine.|Weeks 1, 2 and 4|The FAP (N=291) was the group of subjects who were randomized and received at least 1 dose of the double-blind study drug, and had at least 1 efficacy assessment.|||score on a scale||Standard Error|Mean
2541354|NCT03028636|Other Pre-specified|The FIQOL (Fecal Incontinence Quality of Life) Questionnaire - Average Change From Baseline Score|The Fecal Incontinence Quality of Life (FIQOL) scale is a 41-item, validated questionnaire completed by the subject. FIQOL has 4 subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Each subscale score ranges from 1 to 5, with 1 indicating a lower functional status of quality of life. FIQOL score will be used to assess the changes in quality of life in each of the subscales in comparison to the same scores prior to joining the LIBERATE study.The change from baseline in each of the 4 subscale scores (lifestyle, coping/behavior, depression/self-perception, embarrassment) will be calculated. As higher numbers indicate higher function, a positive change is desirable.|12 months||||Score on a scale||Standard Deviation|Mean
2541355|NCT03028636|Secondary|Patient Global Impression of Improvement (PGI-I) - Average Change From Baseline Score|The Patient Global Impression of Improvement (PGI-I) is a validated global index used to rate the response of a condition to a therapy on a scale from 1 (Very much better) to 7 (Very much worse). The PGI-I will be used to assess improvement of accidental bowel leakage at 3, 6, 9, and 12 months in comparison to how it was prior to joining the LIBERATE study. The average PGI-I score, computed as the mean score across all completed assessments, will be calculated.|3, 6, 9, and 12 months||||Participants|||Count of Participants
2541356|NCT03028636|Primary|The St. Mark's (Vaizey) Incontinence Severity Score - Average Change From Baseline Score|The score is based on 7 questions and is a measure of severity of fecal incontinence (FI) symptoms, which has been shown to correlate with improvement in frequency of FI episodes and subjects' perceptions of relief. The score reflects the severity of FI and ranges from 0 (complete continence, better outcome) to 24 (complete incontinence, worse outcome). A reduction in the St. Mark's score is a better outcome. The mean change from baseline score (prior to treatment) will be calculated and reported at 3, 6, and 12 months.|3, 6, 9, and 12 months|The number analyzed for each time point is the number of participants who provided a survey. Some participants provided surveys for some but not all time points.|||Score on a Scale||Standard Deviation|Mean
2541357|NCT03028467|Secondary|Change From Baseline in Disease Activity Score for 28 Different Joints C-reactive Protein (DAS28 [CRP]) at All Indicated Timepoints|DAS28 (CRP) is a measure of disease activity in rheumatoid arthritis obtained by examination of 28 joints for swelling and tenderness using CRP as a blood biomarker for inflammation. Its components include: Tender/Painful Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), CRP and Patient's Global Assessment of Arthritis. DAS28 (CRP) was calculated by 0.56 (square root of TJC28)+ 0.28 (square root of SJC28)+ 0.36 (natural logarithm [CRP+1])+ (0.014*patients global assessment)+0.96. Scores ranges from 0 to infinity, where higher scores indicates high disease activity. Scores higher than 5.1 indicates high disease activity and scores lower than 2.6 indicates remission. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value. Adjusted mean and standard error of adjusted mean are presented using Mixed Model for Repeated Measures.|Baseline, up to Week 22|ITT Population|||Scores on a scale||Standard Error|Mean
2541358|NCT03028467|Secondary|Number of Participants With Anti-GSK3196165 Antibody Test Results|Serum samples were collected and tested for presence of antibodies that bind to GSK3196165. The presence of treatment emergent anti-drug antibodies (ADA) were determined using a GSK3196165 bridging style ADA assay with a bio-analytically determined cut point determined during assay validation. Samples taken after dosing with GSK3196165 that have a value at or above the cut-point were considered treatment-emergent ADA-positive. These ADA positive samples were further evaluated in a confirmatory assay, and confirmed positive samples were further characterized by assessment of titer. Baseline was considered as the latest pre-dose assessment. Number of participants with post-Baseline negative or positive anti-GSK3196165 antibody test results were presented.|Weeks 2, 4, 12 and 22|Immunogenicity Population. The immunogenicity Population included all participants in the ITT Population, who had at least one immunogenicity assessment.|||Participants|||Count of Participants
2541359|NCT03028467|Secondary|Number of Participants With Urinalysis Dipstick Findings|Urine samples were collected for analysis of presence of glucose and protein in urine by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine protein and glucose can be read as negative, Trace, 1+, 2+ and 3+, indicating proportional concentrations in the urine sample|Up to 22 weeks|ITT Population|||Participants|||Count of Participants
2541360|NCT03028467|Secondary|Number of Participants With Emergent Clinical Chemistry Results Relative to Normal Range|Blood samples were collected to evaluate Albumin, Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Total Bilirubin, Calcium, Cholesterol, Creatine Kinase, C-Reactive protein (CRP), Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, High Density Lipids (HDL), Potassium, Lactate Dehydrogenase, Low Density Lipids (LDL), Sodium, Phosphorus inorganic, Triglycerides, Total Protein and Urea. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose lab value category was unchanged (e.g. High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if they had values that changed 'To Low' and 'To High', so the percentages may not add to 100% in such instances.|Up to 22 weeks|ITT Population|||Participants|||Count of Participants
2541361|NCT03028467|Secondary|Number of Participants With Emergent Hematology Results Relative to Normal Range|Blood samples were collected to evaluate hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), erythrocytes, reticulocytes, white blood cells (WBC), total neutrophils, eosinophils, basophils, monocytes, lymphocytes, platelet count, activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen, erythrocyte sedimentation rate (ESR). Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose lab value category was unchanged (e.g. High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if they had values that changed 'To Low' and 'To High', so the percentages may not add to 100% in such instances.|Up to 22 weeks|ITT Population|||Participants|||Count of Participants
2541429|NCT03026088|Secondary|Left Ventricular End-diastolic Dimension (LVEDD) at Baseline, Week 14 and 26|Left Ventricular End-diastolic Dimension was measured by Ultrasound cardiogram.|Baseline, Week 14 and 26|Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.||||||
2541362|NCT03028467|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings|12-Lead ECGs were taken using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT (QTc) intervals. Number of participants with any abnormal findings in ECG recordings were summarized as clinically significant and not clinically significant. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.|At Week 12|ITT Population|||Participants|||Count of Participants
2541363|NCT03028467|Secondary|Change From Baseline in Respiratory Rate|Vital sign measurements including respiratory rate was measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value.|Baseline and up to 22 weeks|ITT Population|||Breaths per minute||Standard Deviation|Mean
2541364|NCT03028467|Secondary|Change From Baseline in Body Temperature|Vital sign measurements including body temperature was measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value.|Baseline and up to 22 weeks|ITT Population|||Celsius||Standard Deviation|Mean
2541365|NCT03028467|Secondary|Change From Baseline in Heart Rate (HR)|Vital sign measurements including HR was measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value.|Baseline and up to 22 weeks|ITT Population|||Beats per minute||Standard Deviation|Mean
2541366|NCT03028467|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital sign measurements including SBP and DBP were measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value.|Baseline and up to 22 weeks|ITT Population|||Millimeter of mercury||Standard Deviation|Mean
2541367|NCT03028467|Primary|Number of Participants With Any Adverse Event (AE), Serious AE (SAE) and Adverse Events of Special Interest (AESI)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. AESI included serious infections including serious respiratory infections and tuberculosis and opportunistic infections, neutropenia (grade 3 or 4), respiratory events, pulmonary alveolar proteinosis, hypersensitivity reactions including anaphylaxis and injection site reactions.|Up to 22 weeks|Intent-to-Treat (ITT) Population. It included all participants who were randomized to treatment and who received at least one dose of study treatment.|||Participants|||Count of Participants
2541368|NCT03028467|Primary|Terminal Half-life (t1/2) of GSK3196165|Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by standard non-compartmental analysis from the concentration data after last dosing (Day 71). NA indicates data was not available as 95 percent confidence interval could not be calculated when number of participant was not sufficient.|Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155.|PK Population. Only those participants whose parameters could be determined were analyzed.|||Hour||95% Confidence Interval|Geometric Mean
2541369|NCT03028467|Primary|Time to Reach Cmax (Tmax) of GSK3196165|Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by non-compartmental analysis using the concentration data after last dosing (Day 71).|Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155|PK Population. Only those participants whose parameters could be determined were analyzed.|||Hour||Full Range|Median
2541370|NCT03028467|Primary|Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC [0-t]), AUC From Time Zero Extrapolated to Infinity (AUC [0-inf]), AUC Over the Dosing Interval (AUCtau) of GSK3196165|Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by non-compartmental analysis using the concentration data after last dosing (Day 71). NA indicates data was not available as geometric mean and/or 95 percent confidence interval could not be calculated when number of participant was not sufficient.|Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155|PK Population. Only those participants whose parameters could be determined were analyzed (represented by n=X in the category titles).|||Hour*Nanogram per milliliter (hr*ng/mL)||95% Confidence Interval|Geometric Mean
2541371|NCT03028467|Primary|Maximum Observed Concentration (Cmax) of GSK3196165|Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by non-compartmental analysis using the concentration data after last dosing (Day 71). Only those participants whose parameters could be determined were analyzed. PK Population included all GSK3196165-treated participants from whom PK samples were collected and analyzed.|Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155|PK Population. Only those participants with data available at the specified time points were analyzed.|||Nanogram per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
2541412|NCT03026257|Primary|Ex Vivo Total Cholesterol Uptake at Day 30|The contact lens worn in the right eye was removed and stored dry and frozen until analysis. Total cholesterol uptake (cholesterol and cholesterol esters) was evaluated from a sample of the right contact lenses from each site and measured in micrograms. Lower total cholesterol uptake indicates increased lens performance.|Day 30|Full Analysis Set with cholesterol uptake measured|||μg||Standard Deviation|Mean
2541413|NCT03026088|Primary|Change From Baseline in Resting Heart Rate at Week 26|Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.|Baseline, Week 26|Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.||||||
2541372|NCT03028363|Primary|Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12|"Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12~Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions~- Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion~- Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions)~- Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion~- Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions"|Baseline and Week 12|Intent-to-Treat|||Participants|||Count of Participants
2541373|NCT03028363|Primary|Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12|Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12|Baseline and Week 12|Intent-to-Treat|||Lesions||Standard Deviation|Least Squares Mean
2541374|NCT03028363|Primary|Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12|Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12|Baseline and Week 12|Intent-to-Treat|||Lesions||Standard Deviation|Least Squares Mean
2541375|NCT03028220|Secondary|Glucose Variability Measured by CONGA|Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA)|8 weeks||||mmol/l||Inter-Quartile Range|Median
2541376|NCT03028220|Secondary|Glucose Variability Measured by MAGE|Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE)|8 weeks||||mmol/L||Inter-Quartile Range|Median
2541377|NCT03028220|Secondary|Changes in Glucose Variability Measured|Glucose Variability measured by Coefficient of variation (CV), on a decimal scale of 0-1|8 weeks||||percent||Inter-Quartile Range|Median
2541378|NCT03028220|Secondary|Severe Hypoglycaemia|Number of participants with episodes of severe hypoglycaemia|8 weeks||||Participants|||Count of Participants
2541379|NCT03028220|Secondary|Hypoglycemia|Number of participants with hypoglycemic excursions|8 weeks||||Participants|||Count of Participants
2541380|NCT03028220|Secondary|% Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL)|% time spent in hyperglycaemia (>15mmol/L, 270mg/dL) change in baseline to endpoint|10 weeks||||percentage of time >15 mmol/l||95% Confidence Interval|Median
2541381|NCT03028220|Secondary|% Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL)|Percentage time spent in hyperglycaemia (>10mmol/L, 180mg/dL) change in baseline to endpoint|10 weeks||||percentage of time >10mmol/L||95% Confidence Interval|Median
2541382|NCT03028220|Secondary|% Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL)|Percentage time spent in euglycaemia (3.9-10mmol/L, 70-180mg/dL) change in baseline to endpoint|10 weeks||||percentage of time >3.9<10 mmol/l||95% Confidence Interval|Median
2541383|NCT03028220|Secondary|% Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)|Percentage time spent in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) change in baseline to endpoint|10 weeks||||percentage of time >3.9<7.8 mmol/l||95% Confidence Interval|Median
2541384|NCT03028220|Secondary|% Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL)|Percentage time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL) change in baseline to endpint|10 weeks||||percentage of time <3.9mmol/l||95% Confidence Interval|Median
2541385|NCT03028220|Secondary|% Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL)|Percentage time spent in hypoglycaemia (<2.8mmol/L, 50mg/dL) change from baseline|10 weeks||||percentage of time <2.8mmol/l||95% Confidence Interval|Median
2541386|NCT03028220|Primary|% Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL)|Percentage time spent in hypoglycaemia (<3.3mmol/L, 60mg/dL) change from baseline|10 weeks||||percentage of time <3.3mmol/l||Inter-Quartile Range|Median
2541387|NCT03028142|Secondary|Average FEV1 Over 12 Hours on Day 1|Average FEV1 AUC over 12 hours on Day 1|Day 1||||Liters*hour||Standard Deviation|Mean
2541388|NCT03028142|Secondary|Peak FEV1 on Day 1|Peak FEV1 over 4 hours on Day 1|Day 1|All randomized patients with sufficient data collected after intake of study treatment to compute the pharmacodynamics parameters on at least two treatment periods.|||Liters||Standard Deviation|Mean
2541389|NCT03028142|Primary|Average FEV1 Over 12 Hours on the Third Day of Dosing|Average FEV1 area under the curve (AUC) over 12 hours on the third day of dosing|Day 3|All randomized patients with sufficient data collected after intake of study treatment to compute the pharmacodynamics parameters on at least two treatment periods.|||Liters*hour||Standard Deviation|Mean
2541390|NCT03028142|Primary|Peak Forced Expired Volume in 1 Second (FEV1) on the Third Day of Dosing|Peak forced expired volume in 1 second (FEV1) over 4 hours on the third day of dosing|Day 3|All randomized patients with sufficient data collected after intake of study treatment to compute the pharmacodynamics parameters on at least two treatment periods.|||Liters||Standard Deviation|Mean
2541391|NCT03028129|Primary|Quantiferon TB Gold Plus (QIAGEN®) Conversion at the Premature Exclusion Visit.|Number of participants who had a Quantiferon TB Gold Plus (QIAGEN®) score greater than or equal to 0.35 international units per milliliter, at the time of the premature exclusion visit, on all participants in the group.|up to 6 months|All participants who received at least one dose of isoniazid or placebo and who had blood sample collected to QFT examination at premature exclusion visit.|||participants|||Number
2541392|NCT03028025|Secondary|Percent of Patients With Radial Artery Occlusion(RAO)|Radial artery occlusion was monitored for all participants using Barbeau's test and pulse oximetry.|within 30 min of discharge or after 24 hours||||Participants|||Count of Participants
2541393|NCT03028025|Primary|Time to Hemostasis Using the Hemostasis Management System (HMS)|Time to deflation for removal of the TR Band (or TR Band and Statseal) for each group was measured in minutes.|within 30 min of discharge or after 24 hours||||minutes||Standard Deviation|Mean
2541394|NCT03027661|Primary|Pain Reported on the Visual Analogue Scale (VAS) at 60 Minutes Postoperative|Postoperative pain score on the Visual analgoue scale at 60 minutes from surgical stop time. Scale ranges from 0 being no pain, to 10 being worse pain ever experienced.|60 minutes||||VAS scale 0-10||Standard Deviation|Mean
2541395|NCT03027661|Primary|Pain Reported on the Visual Analogue Scale (VAS) at 30 Minutes Postoperative|Scale used is the Visual analogue scale for pain. Scale ranges from 0 being no pain, to 10 being worse pain ever experienced.|30 minutes post-operative stop time||||VAS scale 0-10||Standard Deviation|Mean
2541397|NCT03026556|Secondary|All-cause Mortality|"The event rate of all-cause mortality in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first"|Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years|Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).|||Event Rate in 100 person-years||95% Confidence Interval|Number
2541398|NCT03026556|Secondary|TIA|"The event rate of transient ischemic attack (TIA) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first"|Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years|Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).|||Event Rate in 100 person-years||95% Confidence Interval|Number
2541399|NCT03026556|Secondary|Lower GI Bleeding|"The event rate of Lower GI Bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first"|Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years|Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).|||Event Rate in 100 person-years||95% Confidence Interval|Number
2541400|NCT03026556|Secondary|Upper GI Bleeding|"The event rate of Upper GI Bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first"|Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years|Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).|||Event Rate in 100 person-years||95% Confidence Interval|Number
2541401|NCT03026556|Secondary|Major Other Bleeding|"The event rate of major other bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first"|Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years|Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).|||Event Rate in 100 person-years||95% Confidence Interval|Number
2541402|NCT03026556|Secondary|Major Urogenital Bleeding|"The event rate of major urogenital bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first."|Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years|Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).|||Event Rate in 100 person-years||95% Confidence Interval|Number
2541403|NCT03026556|Secondary|Major GI Bleeding|"The event rate of major GI bleeding (Upper GI Bleeding and Lower GI Bleeding) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first"|Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years|Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).|||Event Rate in 100 person-years||95% Confidence Interval|Number
2541414|NCT03026088|Primary|Change From Baseline in Resting Heart Rate at Week 14|Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.|Baseline, Week 14|Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.||||||
2541458|NCT03023709|Primary|Number of Participants Who Received Influenza Vaccine||Day 0|Study halted after Pilot Phase|||Participants|||Count of Participants
2541404|NCT03026556|Secondary|Major Extracranial Bleeding|"The event rate of major extracranial bleeding (Major GI bleeding, Major urogenital bleeding and Major other bleeding) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first"|Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years|Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).|||Event Rate in 100 person-years||95% Confidence Interval|Number
2541405|NCT03026556|Secondary|Major Intracranial Bleeding|"The event rate of major intracranial bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first"|Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years|Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).|||Event Rate in 100 person-years||95% Confidence Interval|Number
2541406|NCT03026556|Secondary|Hemorrhagic Stroke|"The event rate of Hemorrhagic stroke in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first."|Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years|Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).|||Event Rate in 100 person-years||95% Confidence Interval|Number
2541407|NCT03026556|Secondary|Ischemic Stroke|"The event rate of ischemic stroke in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first"|Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years|Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).|||Event Rate in 100 person-years||95% Confidence Interval|Number
2541408|NCT03026556|Primary|Overall Major Bleeding|"The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first."|Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years|Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed and matched 1: 1 based on their baseline characteristics using the propensity score matching (PSM).|||Event Rate in 100 person-years||95% Confidence Interval|Number
2541409|NCT03026556|Primary|Stroke Overall (Hemorrhagic, Ischemic, Uncertain)|"The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Length of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest:~The day of discontinuation of the index NOAC exposure;~The day before a switch to an anticoagulant different from the index exposure;~The day before a change in dose for the index NOAC;~The end of continuous eligibility of a patient in the health plan (disenrollment);~The end of the study observation period; or~The date of death of the patient."|Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years|Based on Department of Defense (DoD) outpatient prescription dispensed data the two separate study cohorts dabigatran vs rivaroxaban cohort and dabigatran vs apixaban cohort were formed. In both cohorts, dabigatran patients were matched 1:1 to comparator patients based on their baseline characteristics using the propensity score matching (PSM).|||Event Rate in 100 person-years||95% Confidence Interval|Number
2541410|NCT03026530|Secondary|Postoperative Nausea|A questionnaire was used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively. The questionnaire involved a numeric rating scale (NRS) from 0 to 10, where 0 signified no nausea, and10 the worst imaginable nausea.|4, 12, 24, 36 and 48 hours after surgery||||score on a scale||Inter-Quartile Range|Median
2541411|NCT03026530|Primary|Postoperative Pain|A questionnaire with a numeric rating scale (NRS) is used to evaluate pain intensity at 4, 12, 24, 36 and 48 hours postoperatively to assess pain intensity. The scale includes even numbers from 0 to 10, where 0 signifies no pain, and 10 signifies the worst imaginable pain.|4, 12, 24, 36 and 48 hours after surgery||||score on a scale||Inter-Quartile Range|Median
2541459|NCT03023683|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization||||Participants|||Count of Participants
2541460|NCT03023683|Primary|Number of Participants From Each Arm Who Received Influenza Vaccine||Day 0 to 28||||Participants|||Count of Participants
2541416|NCT03026088|Secondary|Number of Participants With Medicine Compliance Assessed by Medication Procession Ratio (MPR)|MPR is used to assess the medicine compliance. MPR is defined as the actual drug number taken by the participants divided by the drug number should be taken by the participants according to the protocol. MPR between 80%-100% is defined as good compliance. Medication rate of less than (<) 80% or greater than (>)100% is defined as insufficient compliance.|Up to Week 26|The safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2541417|NCT03026088|Secondary|Number of Participants With 24 Hour Heart Rate With More Than 70 Beats Per Minute (Bpm) and Less Than 55 Bpm|Holter monitor was used to measure heart rate.|Baseline, week 6, 14 and end of treatment (Week 26)|The safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2541418|NCT03026088|Secondary|Number of Participants With Arrhythmia|Holter monitor was used to diagnose arrhythmia.|Baseline up to end of treatment (Week 26)|The safety population included all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2541419|NCT03026088|Secondary|Mean 24 Hour, Day Time and Night Time Heart Rate|Holter monitor was used to measure heart rate (24 hour, day time, night time).|Baseline, week 6, 14 and end of treatment (Week 26)|Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.||||||
2541420|NCT03026088|Secondary|Number of Participants With Abnormal Value of N-terminal Pro-B-type Natriuretic Peptide (NT Pro-BNP)|Routine blood tests was performed to measure NT Pro-BNP. The normal range for NT Pro-BNP varies from 0 picograms/milliliter (pg/mL) (lower limit of normal value) -125 pg/mL (upper limit of normal value).|Baseline up to End of treatment (Week 26)|The safety population included all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2541421|NCT03026088|Secondary|6-Minute Walk Test|6-min walk test was a practical simple test that requires a 100-feet hallway but no exercise equipment or advanced training for technicians. Walking is an activity performed daily by all but the most severely impaired participants. This test measures the distance that a participant can quickly walk on a flat, hard surface in a period of 6 minutes.|Baseline and End of treatment (Week 26)|Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.||||||
2541422|NCT03026088|Secondary|Quality of Life Based on the Medical Outcomes Study Item Short From Health Survey (SF-36) at Baseline and End of Treatment|Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health. The individual question items (Likert scale 0-4) are first summed for each item under the various sections. Then, those summary scores are then standardized on a scale between 0 and 1 using the mean and standard deviation of the actual scores and finally, weighted to a scale between 0 and 100. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.|Baseline, end of treatment (Week 26)|Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.||||||
2541423|NCT03026088|Secondary|Quality of Life Based on Minnesota Living With Heart Failure (MLHF) at Baseline and End of Treatment|MLHF questionnaire has 21 items. Questions assess the impact of frequent physical symptoms of heart failure and the effects of heart failure on physical and social functions. Each question had a possible score of 0 (best) to 5 (worst), for a total of 0 to 105. The higher the summed score, the worse is the impact of heart failure on a participant's quality of life.|Baseline, end of treatment (Week 26)|Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.||||||
2541424|NCT03026088|Secondary|Percentage of Participants With Resting Heart Rate Less Than 70 Beats Per Minute (Bpm) and More Than 55 Bpm|Resting heart rate measurement was taken at sitting position for a continuous record of 3 minutes. Heartbeats in each minute was calculated and averaged to obtain the resting heart rate.|Baseline up to Week 26|The safety population included all subjects who received at least one dose of study treatment.|||percentage of participants|||Number
2541425|NCT03026088|Secondary|Number of Participants With New York Heart Association (NYHA) Class|The NYHA classification assesses the severity of symptoms of heart failure. Here NYHA class of II - IV was assessed. NYHA II: Slight limitation of physical activity, comfortable at rest, but ordinary physical activity results in undue breathlessness, fatigue or palpitation. NYHA III: Marked limitation of physical activity, comfortable at rest, but less than ordinary activity causes undue breathlessness, fatigue or palpitation. NYHA IV: Unable to carry on any physical activity without discomfort, symptoms at rest can be present. If any physical activity is undertaken, discomfort increased.|Baseline, Week 26|The safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2541426|NCT03026088|Secondary|Number of Participants With Clinically Relevant Systolic and Diastolic Blood Pressure|Blood pressure (systolic and diastolic) measurement was taken at sitting position, with the elbow at the same level with the heart. Number of participants with clinically relevant systolic and diastolic blood pressure reported based on the assessment of the investigator.|Screening (Week -2) up to Week 26|The safety population included all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2541427|NCT03026088|Secondary|Ratio of Early (E) to Late (A) Ventricular Filling Velocities (E/A Ratio) at Baseline, Week 14 and Week 26|Early to late ratio was measured by ultrasound cardiogram.|Baseline, Week 14 and Week 26|Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.||||||
2541428|NCT03026088|Secondary|Interventricular Septal Thickness (IVST) at Baseline, Week 14 and 26|Interventricular septal thickness was measured by Ultrasound cardiogram.|Baseline, Week 14 and 26|Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.||||||
2541430|NCT03026088|Secondary|Left Ventricular End-Systolic Dimension (LVESD) at Baseline, Week 14 and 26|Left Ventricular End-Systolic Dimension was measured by Ultrasound cardiogram.|Baseline, Week 14 and 26|Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.||||||
2541431|NCT03026088|Secondary|Left Ventricular Ejection Fraction (LVEF) at Baseline, Week 14 and 26|LVEF was defined as the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat and it is used to measure the cardiac output for the heart. Ultrasound cardiogram performed to measure LVEF.|Baseline, Week 14 and 26|Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.||||||
2541432|NCT03026088|Secondary|Change From Baseline in Resting Heart Rate at Week 3, 10 and 18|Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.|Baseline, Week 3, 10 and 18|Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.||||||
2541433|NCT03026088|Primary|Change From Baseline in Resting Heart Rate at Week 6|Heartbeats in each minute were calculated and averaged to obtain the resting heart rate.|Baseline, Week 6|Data was not collected since the study was terminated early due to limited beta-blocker naive participants among newly diagnosed heart failure participants which led barrier to the recruitment.||||||
2541434|NCT03026075|Primary|Performance of MCS in Cleansing a Poorly Prepared Colon.|The rate of adequate cleansing level per subject will be evaluated by the Boston Bowel Preparation (BBPS) scoring index before and post the cleansing operation.|Up to 2 hours|the bowel preparation level before and after the use of Motus Cleansing System was evaluated using the Boston Bowel Preparation Scale (BBPS) where patients consider to have adequate cleansing level if all 3 colon segments graded 2 or 3 ( good or excellent)|||Participants|||Count of Participants
2541435|NCT03025945|Primary|Post-operative Clinical Findings of Cystoid Macular Edema|post-operative macular volume (mm)|6 weeks||||mm|Eyes|Standard Deviation|Mean
2541436|NCT03025217|Secondary|Perceived Stress Scale|Change in perceived stress as measured by the PSS-10 questionnaire administered at baseline (week 0) and post intervention (week 26). Score range is 0 - 40 with higher scores indicating higher perceived stress.|26 weeks||||score on a scale||Standard Deviation|Mean
2541437|NCT03025217|Primary|Change in Weight|Change in weight between baseline (week 0) and post intervention (week 26)|26 weeks|Program Completers|||pounds||Standard Deviation|Mean
2541438|NCT03024606|Primary|Exhaled Carbon Monoxide Levels|self-reported cessation rates at 1 month, as verified by exhaled carbon monoxide levels|1 month||||Participants|||Count of Participants
2541439|NCT03024112|Secondary|ICU Length of Stay||30 days||||Days||Standard Deviation|Mean
2541440|NCT03024112|Secondary|Lowest Oxygen Saturation Level Measured|Lowest oxygen saturation level measured during hospitalization from admission to discharge|30 days||||percentage of oxygen saturation||Standard Deviation|Mean
2541441|NCT03024112|Secondary|Hospital Length of Stay|length of stay from hospital admission to hospital discharge|30 days||||Days||Standard Deviation|Mean
2541442|NCT03024112|Primary|Number of Participants With Post-operative Pulmonary Complications|"The primary outcome post-operative pulmonary complication is defined as present if any one of the following criteria are met:~SpO2 < 90% with FiO2 ≥ 50%~Dyspnea at rest~Respiratory rate > 25 breaths/min~Active use of accessory respiratory muscles~PaO2/FiO2 ratio < 200~Escalation of therapy to non-invasive ventilation~Re-intubation~Occurrence of hospital-acquired pneumonia~Re-admission to the ICU"|30 days||||Participants|||Count of Participants
2541443|NCT03023891|Primary|Glucose Tolerance Test: Area Under the Curve (AUC) for C-peptide Levels|"AUC for C-peptide during glucose tolerance test at baseline and 4-8 hours after prednisone.~C-peptide levels were measured at 0, 10, 20, 30, 60, 90, and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)"|baseline and 4-8 hours after drug administration||||ng*min/mL||Standard Deviation|Mean
2541444|NCT03023891|Primary|Glucose Tolerance Test: Area Under the Curve (AUC) for Insulin Levels|"AUC for insulin levels during glucose tolerance test at baseline and 4-8 hours after prednisone.~Insulin levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration administration (Visit 2)."|baseline and 4-8 hours after drug administration||||μU*min/mL||Standard Deviation|Mean
2541445|NCT03023891|Primary|Glucose Tolerance Test: Area Under the Curve (AUC) for Plasma Glucose|"AUC for plasma glucose during glucose tolerance test at baseline and 4-8 hours after drug administration.~Plasma glucose levels were measured at 0, 10, 20, 30, 60, 90 and 120 minutes during glucose tolerance test at baseline (Visit 1) and after drug administration (Visit 2)"|baseline and 4-8 hours after drug administration||||mg*min/dL||Standard Deviation|Mean
2541446|NCT03023891|Primary|White Blood Cell Counts|White Blood Count at baseline (Visit 1) and within 4 to 8 hours after drug administration (Visit 2)|baseline and within 4 and 8 hours after drug administration||||x10^3 cells/mL||Standard Deviation|Mean
2541447|NCT03023878|Secondary|Pharmacokinetics (PK) Results for Blinatumomab: Clearance for Cycle 1|PK blood samples were analyzed in a central lab.|Day 2 at least 24 hours after blinatumomab was started and on Day 9 and Day 16 at least 24 hours after blinatumomab dose was increased in the cycle|Pharmacokinetic Analysis Set: participants who received any infusion of blinatumomab and had at least one PK sample collected|||L/Hour||Standard Deviation|Mean
2541448|NCT03023878|Secondary|Pharmacokinetics (PK) Results for Blinatumomab: Steady-State Concentrations at Week 1, Week 2 and Week 3 for Cycle 1|"The steady-state serum concentration (Css), summarized as the observed concentrations collected after at least 10 hours after the start of continuous IV infusion.~PK blood samples were analyzed in a central lab."|Day 2 at least 24 hours after blinatumomab was started and on Day 9 and Day 16 at least 24 hours after blinatumomab dose was increased in the cycle|Pharmacokinetic Analysis Set: participants who received any infusion of blinatumomab and had at least one PK sample collected|||pg/mL||Standard Deviation|Mean
2541449|NCT03023878|Secondary|Percentage of Participants Who Had Hematopoietic Stem Cell Transplantation (HSCT) (as of the Database Snapshot Date of 22 October 2019)|Percentage of participants who had HSCT during the Long Term Follow-Up Period.|Day 1 up to 14.5 months|Full Analysis Set (FAS)|||percentage of participants||95% Confidence Interval|Number
2541450|NCT03023878|Secondary|Kaplan-Meier Estimates for Progression Free Survival (PFS) From First Dose of Bilinatumomab (as of the Database Snapshot Date of 22 October 2019)|PFS was calculated as the time from the date of first IP infusion until the date of diagnosis of progression of DLBCL or the date of death, whichever was the earliest. The diagnosis of progression of DLBCL was defined as the first diagnosis of progressive metabolic response/progressive disease based on PET/CT scan per central or investigator review during the treatment period or relapse based on clinical tumor assessment during the long-term follow up period. Participants who were alive and did not have progression were censored at the last evaluable non-missing tumor assessment date prior to the analysis trigger date.|The median (range) follow-up time was 8.3 (4.4, 14.5).|Full analysis set (FAS)|||months||95% Confidence Interval|Median
2541451|NCT03023878|Secondary|Kaplan-Meier Estimates for Overall Survival (OS) From First Dose of Bilinatumomab (as of the Database Snapshot Date of 22 October 2019)|"OS was calculated as the time from the date of first IP infusion until death due to any cause. Participants who are alive at the date that triggers the analysis were censored at the date last known to be alive.~Months were calculated as days from the first dose date of blinatumomab to death/censor date, divided by 30.5."|The median (range) follow-up time was 9.2 (5.2, 14.5) months.|Full analysis set (FAS)|||months||95% Confidence Interval|Median
2541452|NCT03023878|Secondary|Complete Response Rate Expressed as the Percentage of Participants Achieving Complete Metabolic Response (CMR) Using Lugano 2014 Criteria During Cycle 1 and During Treatment Period|"Tumor response assessment was performed by a central reader according to modified Lugano classification using PET/CT scan.~CMR: a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with/without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology."|Cycle 1: Day 78 (3 weeks following end of Cycle 1 IP treatment) Treatment Period: Either the Cycle 1 timeframe or approximately Day 128 (3 weeks after Cycle 2 ended) for participants who completed Cycle 2|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2541453|NCT03023878|Secondary|Kaplan-Meier Estimates for Duration of Response (as of the Database Snapshot Date of 22 October 2019)|"Duration of response was calculated only for responders during cycle 1. For participants who had CR or PR on the PET/CT scan at the end of the run-in period, response was measured from the start of blinatumomab treatment. For participants who had stable disease at the end of the run-in period, duration was calculated from documentation of the first assessment of either PR or CR on blinatumomab.~Progression was defined as the first diagnosis of progressive metabolic response/progressive disease based on PET/CT scan per central or investigator review during the treatment period or relapse based on clinical tumor assessment during the long-term follow up period.~Response duration was calculated until the start of new anti-tumor treatment (excluding any stem cell transplantation), PD, or death, whichever was the earliest event. Participants who did not have new anti-tumor treatment (excluding stem cell transplantation), PD, or death were censored at the last tumor assessment date."|The median (range) follow-up time was 7.6 (4.4, 14.5) months|Responder Analysis Set includes all participants in the FAS that achieve objective response (CR or PR as per the Lugano classification) on the PET/CT scan.|||months||95% Confidence Interval|Median
2541454|NCT03023878|Secondary|Overall Objective Response Rate (ORR) Expressed as the Percentage of Participants Achieving Complete Metabolic Response (CMR) and Partial Metabolic Response (PMR) Using Lugano 2014 Criteria During Cycle 1 and During Treatment Period|Tumor response assessment was performed by a central reader according to modified Lugano classification using PET/CT scan. Overall objective response rate (ORR) is the percentage of participants with a best overall response of complete metabolic response (CMR) or partial metabolic response (PMR). CMR: a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with/without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PMR: a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline.|Cycle 1: Day 78 (3 weeks following end of Cycle 1 IP treatment) Treatment Period: Either the Cycle 1 timeframe or approximately Day 128 (3 weeks after Cycle 2 ended) for participants who completed Cycle 2|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2541455|NCT03023878|Primary|Participants With Treatment-Emergent Adverse Events Related to Blinatumomab Treatment|"Overall incidence and severity of treatment-emergent adverse events deemed by investigators to be related to blinatumomab treatment. Severity was graded by investigators according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and based on the scale:~Grade 1 = Mild - transient or mild discomfort; Grade 2 = Moderate - mild to moderate limitation in activity, assistance may be needed; minimal medical intervention required; Grade 3 = Severe - marked limitation in activity, assistance usually required; medical intervention required, hospitalization is possible; Grade 4 = Life threatening - extreme limitation in activity, assistance required; medical intervention, hospitalization or hospice care probable; Grade 5 = death."|From the start of first infusion of IP to 30 days after the end of last infusion of IP; median (min, max) treatment duration was 56 (16, 84) days|Full analysis set|||Participants|||Count of Participants
2541456|NCT03023878|Primary|Participants With Treatment-Emergent (Blinatumomab) Adverse Events|"Overall incidence and severity of treatment-emergent adverse events occurring during the blinatumomab investigative product (IP) treatment period graded by investigators according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and based on the scale:~Grade 1 = Mild - transient or mild discomfort; Grade 2 = Moderate - mild to moderate limitation in activity, assistance may be needed; minimal medical intervention required; Grade 3 = Severe - marked limitation in activity, assistance usually required; medical intervention required, hospitalization is possible; Grade 4 = Life threatening - extreme limitation in activity, assistance required; medical intervention, hospitalization or hospice care probable; Grade 5 = death."|From the start of first infusion of IP to 30 days after the end of last infusion of IP; median (min, max) treatment duration was 56 (16, 84) days|Full analysis set|||Participants|||Count of Participants
2541457|NCT03023709|Primary|Number of Participants With Related Adverse Events||Day 0 to 14 post-immunization||||Participants|||Count of Participants
2541463|NCT03023488|Secondary|Post-Operative Characteristics - Complications|"The number of patients that had a complication in the first 1 month after the operation according to the Clavien Dindo Grading system (0-5).~Clavien Dindo Grading ranges from 0 (mildest) to 5 (most severe). 0. No complications~Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are drugs as antiemetics, antipyretics, analgesics, diuretics, electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside~Complications requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included~Complications requiring surgical, endoscopic or radiological intervention~Life-threatening complications (including CNS complications) requiring IC/ICU management~Death"|The data will be recorded within 1 month after each procedure.||||Participants|||Count of Participants
2541464|NCT03023488|Secondary|Operative Characteristics - Intraoperative Complications|The number of patients that has experienced any kind of intraoperative complications during the flexible ureteroscopy operation.|1 hour after the operation||||participants|||Number
2541465|NCT03023488|Secondary|Operative Characteristics - Irrigation Pressure|The pressure that is applied to the irrigation solution which is circulated through the ureteroscope that is used to expand the renal cavities during a flexible ureteroscopy operation. the data will be collected in cmH2O. This pressure value is a constant value and it doesn't change throughout the length of the procedure.|1 hour after the operation||||cmH2O||Full Range|Median
2541466|NCT03023488|Secondary|Duration of the Flexible Ureteroscopy Operation|the data about the duration of the operation that will be performed for each patient and the data will be recorded in minutes.|10 minutes after the operation||||min||Standard Deviation|Mean
2541467|NCT03023488|Secondary|Technical Details - Name of Flexible Ureteroscope|Each ureteroscope has unique characteristics. So, every ureteroscope that will be used, will be recorded with its name. E.g. Storz Flex-X2, Olympus V1, Wolf Cobra|1 hour after the operation||||participants|||Number
2541468|NCT03023488|Secondary|Technical Details - Size of Ureteral Access Sheath|The size of access sheaths will be given in French measurement. E.g. 10/12 Fr|1 hour after the operation||||participants|||Number
2541469|NCT03023488|Primary|Pulsatility Index (PI) Calculation by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.|"Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.~Pulsatility index is calculated as the difference between PSV and EDV, divided by the mean velocity [(PSV - EDV) / ((PSV + EDV) / 2)].~Pulsatility index is used to discriminate between renal and pre-renal causes of acute kidney injury which can alter the therapeutic options in the clinical setting."|The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation||||unitless||Full Range|Median
2541470|NCT03023488|Primary|Resistive Index (RI) Calculation by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.|"Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.~Resistive index is calculated as the difference between PSV and EDV, divided by PSV [(PSV - EDV) / (PSV)].~An increased resistive index can be considered as a marker of intrarenal arterial stiffness and is associated with worsening of renal function and tubulointersitial damage."|The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation||||unitless||Full Range|Median
2541471|NCT03023488|Primary|End Diastolic Velocities (EDV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.|"Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.~EDV is the velocity in the renal and arcuate arteries at the end of the diastolic phase of each heart pulse."|The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation||||cm/s||Full Range|Median
2541499|NCT03022799|Secondary|Change From Baseline Total Tau in CSF (Part B)|To evaluate Total Tau in CSF of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.|CSF - Part B: Day 1 (at -120 minutes to 0 minute prior to the first dosing) and on Day 7 (at 1 hour after last dosing)|All subjects who received at least one dose in Part B|||pg/mL||Full Range|Mean
2541500|NCT03022799|Secondary|Alpha Synuclein Oligomer in Plasma and CSF (Part B)|To evaluate Alpha synuclein oligomer in plasma and CSF of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.|Plasma - Part B: Day 7 (at 1 hour after last dosing) / CSF - Part B: Day 7 (at 1 hour after last dosing)|All subjects who received at least one dose in Part B|||pg/mL||Full Range|Mean
2541472|NCT03023488|Primary|Peak Systolic Velocities (PSV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by Demonstrating the Change Between the Pre-operative and Post-operative Parameters.|"Doppler US will be performed at two times: 2 days prior to surgery and within the first 24 hours following F-URS to show the change between the pre-operative and post-operative periods. Doppler examination includes renal arteries and arcuate arteries. For each patient, the following parameters are measured: peak systolic velocities (PSV) and end diastolic velocities (EDV), resistive index (RI) and pulsatility index (PI) of the arteries. The unit for PSV and EDV is cm/sec. RI and PI doesn't have a unit, they are quantitative measures calculated from PSV and EDV.~PSV is the maximum velocity in the renal and arcuate arteries in the systolic phase of each heart pulse."|The doppler examination will be performed 2 days before surgery and the change will be assessed within 1 day of the operation. So, the initial evaluation will be performed and change of values will be assessed 72 hours after the initial evaluation||||cm/s||Full Range|Median
2541473|NCT03023423|Secondary|Number of Participants With Anti-Atezolizumab Antibodies|Number of participants with antibodies to atezolizumab (tested using a validated immunoassay method) were reported. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'.|Up to 1.5 years|The immunogenicity-evaluable analysis set included all participants who received at least 1 dose of atezolizumab or daratumumab and had appropriate samples for detection of antibodies to atezolizumab or daratumumab.|||Participants|||Number
2541474|NCT03023423|Secondary|Number of Participants With Anti-Daratumumab Antibodies|Number of participants with antibodies to daratumumab (tested using a validated immunoassay method) were reported. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'.|Up to 1.5 years|The immunogenicity-evaluable analysis set included all participants who received at least 1 dose of atezolizumab or daratumumab and had appropriate samples for detection of antibodies to atezolizumab or daratumumab. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Participants|||Number
2541475|NCT03023423|Secondary|Atezolizumab Serum Concentration|Atezolizumab serum concentrations were reported. Each cycle was of 21-days. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'.|C1D1:predose and postdose; C1D2:predose and postdose; C2D1, C3D1:predose; C3D15:predose and postdose; C4D1:predose and postdose; C8D1:predose and postdose; C12D1:predose; end of treatment (37 days after last dose); and post last dose (up to 1.5 years)|PK-evaluable analysis set: all participants who received at least 1 dose of daratumumab/atezolizumab and had at least 1 postinfusion sample collected. Here N (number of participants analyzed): participants evaluable for this outcome measure, and n (number of participants analyzed): participants evaluable for this outcome measure at given timepoint.|||Microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2541476|NCT03023423|Secondary|Daratumumab Serum Concentration|Daratumumab serum concentrations were reported. Each cycle was of 21-days. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'.|Cycle 1 Day 1 (C1D1):predose and postdose; C2D1 and C3D1:predose; C3D15: predose and postdose; C4D1: predose and postdose; C8D1: predose and postdose; C12D1: predose; end of treatment (37 days after last dose); and post last dose (up to 1.5 years)|Pharmacokinetic (PK)-evaluable analysis set included all participants who had received at least 1 dose of daratumumab or atezolizumab and had at least 1 postinfusion sample collected. Here ‘n’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure at a given time point.|||Microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2541477|NCT03023423|Secondary|Overall Survival (OS)|Overall Survival was defined as the duration from the date of randomization to the date of participant's death due to any cause. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'.|Up to 1.5 years|ITT analysis set included all participants who had entered the Randomized phase of the study.|||Months||95% Confidence Interval|Median
2541478|NCT03023423|Secondary|Progression-Free Survival (PFS)|"PFS was defined as the duration from the date of randomization until the first documented disease progression (PD) or death, whichever occurred first. PD: Sum of diameters increased by >=20% and >=5 millimeter (mm) from nadir (including baseline if it was smallest sum). Participants with measurable disease: for unequivocal progression based on non-target disease, overall level of substantial worsening that merits discontinuation of therapy (if target disease was stable disease [SD]/PR). Participants without measurable disease: for unequivocal progression of non-target disease, increase in overall tumor burden comparable to increase required for PD of measurable disease. Appearance of 1/ more new lesions or unequivocal progression of non-target lesion was also considered as PD. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'."|Up to 1.5 years|ITT analysis set included all participants who had entered the Randomized phase of the study.|||Months||95% Confidence Interval|Median
2541479|NCT03023423|Secondary|Clinical Benefit Rate|Clinical benefit rate was defined as percentage of participants who achieved disease control (CR, PR, or SD). RECIST 1.1 Criteria for CR: Disappearance of all target lesions; all lymph nodes of non-pathological in size (<10 mm short axis); normalization of tumor marker level. Criteria for PR: >=30 % decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Criteria for SD: <30% decrease in sum of diameters of all target lesions compared with baseline and <20% increase compared with nadir, in absence of new lesions or unequivocal progression of nontarget lesions. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'.|Up to 1.5 years|ITT analysis set included all participants who had entered the Randomized phase of the study.|||Percentage of Participants||95% Confidence Interval|Number
2541514|NCT03022799|Secondary|Tmax (Time to Achieve Maximum Observed Plasma Concentration Determined Directly From the Concentration-time Profile)|To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.|Part A:Day 1 to 4; Part B: Day 1 to Day 8|All subjects who received at least one dose.|||hours||Full Range|Median
2541700|NCT03020576|Secondary|Change in Hand and Pinch Strength|quantitative assessment of hand strength using standard dynamometry measurements in units of kilograms|Through study completion, an average of 8 weeks||||change in kilograms||Standard Deviation|Mean
2541480|NCT03023423|Secondary|Duration of Response (DoR)|"Duration of response was defined as duration from date of initial documentation of disease response to date of first objectively documented evidence of recurrence or progressive disease (PD) or death, whichever occurred first. PD: Sum of diameters increased by >=20% and >=5 millimeter (mm) from nadir (including baseline if it was smallest sum). Participants with measurable disease: for unequivocal progression based on non-target disease, overall level of substantial worsening that merits discontinuation of therapy (if target disease was stable disease [SD]/PR). Participants without measurable disease: for unequivocal progression of non-target disease, increase in overall tumor burden comparable to increase required for PD of measurable disease. Appearance of 1/ more new lesions or unequivocal progression of non-target lesion was also considered as PD. The OM was planned to be reported for participants based on their initial assignment to 'Randomized Phase: Atezolizumab'."|Up to 1.5 years|ITT analysis set included all participants who had entered the Randomized phase of the study. Here, N (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Months||95% Confidence Interval|Median
2541481|NCT03023423|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Crossover participants were counted twice (in 'Randomized Phase: Atezo arm' and in 'Randomized Phase: Atezo Crossed Over to Dara + Atezo') for safety analysis. For cross-over participants, AEs after initiation of cross-over treatment were summarized separately in the crossover arm, however, AEs occurred before crossover treatment were included in 'Randomized Phase: Atezolizumab arm'.|Up to 1.5 years|Safety analysis set included all participants who had received at least 1 administration of any study medication.|||Participants|||Number
2541482|NCT03023423|Primary|Percentage of Participants With Overall Response Rate (ORR)|ORR was defined as the percentage of participants with partial response (PR) or complete response (CR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Criteria for CR: Disappearance of all target lesions; all lymph nodes must be of non-pathological in size (less than [<]10 millimeter [mm] short axis; normalization of tumor marker level. Criteria for PR: greater than or equal to (>=)30 percent (%) decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Overall Response (OR) = CR + PR. The outcome measure (OM) was planned to be reported for participants based on their initial assignment to Randomized Phase: Atezolizumab'.|Up to 1.5 years|Intent-to-treat (ITT) analysis set included all participants who had entered the Randomized phase of the study.|||Percentage of participants||95% Confidence Interval|Number
2541483|NCT03023176|Secondary|Number of Participants With Related Adverse Events||Day 0 to 32 post-immunization||||Participants|||Count of Participants
2541484|NCT03023176|Primary|Number of Participants Who Received Influenza Vaccine||Day 0 to 32||||Participants|||Count of Participants
2541485|NCT03023137|Secondary|Neonates With Hypoglycemia|Hypoglycemia was defined as any blood glucose concentration ≤ 40 mg/dL.|One, two and fours hours after birth|A total of 153 babies were born alive in group W&D and 91 in the control group.|||babies|||Number
2541486|NCT03023137|Secondary|Appropriate-for-gestational Age Babies||End of pregnancy|A total of 153 babies were born alive in group W&D and 91 in the control group.|||babies|||Number
2541487|NCT03023137|Secondary|Babies Born at Term||End of pregnancy|A total of 153 babies were born alive in group W&D and 91 in the control group.|||babies|||Number
2541488|NCT03023137|Secondary|Live-born Children||End of pregnancy|A total of 153 babies were born alive in group W&D and 91 in the control group.|||babies|||Number
2541489|NCT03023137|Secondary|Second and Third-trimester Losses||28 weeks of gestation and end of gestation|Since we excluded multiple gestations, there were 174 single pregnancies in group W&D and 162 in the control group.|||fetuses|||Number
2541490|NCT03023137|Secondary|First-trimester Losses||14 weeks of gestation|Since we excluded multiple gestations, there were 174 single pregnancies in group W&D and 162 in the control group.|||embryos|||Number
2541491|NCT03023137|Secondary|Excessive Weight Gain|Weight gain >13 kg for underweight, normal weight or overweight mothers and > 9 kg for obese mothers|End of term pregnancies|A total of 148 pregnancies in group W&D and 57 pregnancies in the control group reached term.|||mothers|||Number
2541492|NCT03023137|Secondary|Mothers Who Used Heparin for Nephrotic Range Proteinuria or Placental Insufficiency||End of pregnancy||||mothers|||Number
2541493|NCT03023137|Secondary|Preeclampsia||Pregnancies reaching 20 weeks' gestation|A total of 154 pregnancies reached 20 weeks in group W&D and 98 in the control group.|||mothers|||Number
2541494|NCT03023137|Secondary|Gestational Diabetes Mellitus||Pregnancies reaching 24 weeks' gestation|A total of 154 pregnancies in group W&D and 98 pregnancies in the control group reached 24 weeks of gestation.|||mothers|||Number
2541495|NCT03023137|Primary|Take-home Baby Rate||End of pregnancy|Since we excluded multiple gestations, there were 174 single pregnancies in group W&D and 162 in the control group.|||babies|||Number
2541496|NCT03022916|Primary|Observe Stability of Nail Polish as Evidenced by Serial Photography With Efinaconazole Application in Terms of Days|Observation: Serial photographs were combined with patient reported outcomes to assess the stability of self-applied toenail polish when efinaconazole was applied topically to the nail. (Expected stability of polish less than 14 days with application of Jublia as compared to nails without Jublia application)|Baseline to 14 days|Healthy adults with normal appearing big toenails applied toenail polish to both big toes. Jublia was applied to one big toe daily on top of the nail polish. Serial photography and participant report demonstrated the day until the nail polish degraded (became damaged). Control results were not analyzed.|||days of stability|nail polish cycle|Standard Deviation|Median
2541497|NCT03022799|Secondary|Ratio of CSF Concentration/Plasma Cmax (Part B)|Ratio of CSF concentration/Plasma Cmax|Plasma - Part B: Day 7 (at 1 hour after last dosing) / CSF - Part B: on Day 7 (at 1 hour after last dosing)|All subjects who received at least one dose in Part B|||Ratio||Full Range|Mean
2541498|NCT03022799|Secondary|Change From Baseline Phospho-Tau in CSF (Part B)|To evaluate Phospho-Tau of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.|CSF - Part B: Day 1 (at -120 minutes to 0 minute prior to the first dosing) and on Day 7 (at 1 hour after last dosing)|All subjects who received at least one dose in Part B|||pg/mL||Full Range|Mean
2541501|NCT03022799|Secondary|Korean Wechsler Adult Intelligence Scale-IV (K-WAIS-IV)|The K-WAIS-IV consists of an assessment of the cognitive ability using a core battery of 10 unique subtests (Block Design, Similarities, Digit Span, Matrix Reasoning, Vocabulary, Arithmetic, Symbol Search, Visual Puzzles, Information, and Coding) that focus on four specific domains of intelligence: verbal comprehension, perceptual reasoning, working memory, and processing speed. The Verbal Comprehension Index, Perceptual Reasoning Index, Working Memory Index, and Processing Speed Index (standard scores: mean=100, standard deviation=15) that are all based on a number of core and supplemental subtests (scaled scores: mean=15, standard deviation=3) that provide pertinent clinical information and flexibility in implementation. The higher values represent a better outcome.|Part A: Day 1; Part B: Day 7|All subjects who received at least one dose|||Intelligence quotient (IQ)||Standard Deviation|Mean
2541502|NCT03022799|Secondary|Change From Baseline for Bond and Lader Visual Analogue Scale (VAS)|"The Bond-Lader Visual Analogue Scales (VAS) will be analyzed using 3 factor scores: alertness, contentedness, and calmness. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered. Baseline is defined as the last available recording prior to dosing on Day 1.~Alertness (Range 0 to 100, the higher scores indicated more alertness)~Mood (Range 0 to 100, where higher scores indicated elevated mood)~Calmness (Range 0 to 100, where higher scores indicated more calmness)."|At Day 1 (3 hours post dose), Day2, Day 3, Day 4, and Day 8.|All subjects who received at least one dose.|||units on a scale||Standard Deviation|Mean
2541503|NCT03022799|Secondary|AUCtau_D (AUCtau Divided by Dose) (Part B)|To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.|Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,|All subjects who received at least one dose in Part B|||(h*ng/mL)/mg||Full Range|Mean
2541504|NCT03022799|Secondary|Rac (Cmax) (Observed Accumulation by Cmax) (Part B)|To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.|Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,|All subjects who received at least one dose in Part B|||ratio||95% Confidence Interval|Geometric Mean
2541505|NCT03022799|Secondary|Rac(AUC) (Observed Accumulation by AUC) (Part B)|To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects multiple oral doses of KM-819 in elderly male subjects.|Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,|All subjects who received at least one dose in Part B|||ratio||95% Confidence Interval|Geometric Mean
2541506|NCT03022799|Secondary|AUCtau (Area Under the Plasma Concentration-time Curve for a Dosing Interval) (Part B)|To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects multiple oral doses of KM-819 in elderly male subjects.|Part B: Day 1 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours postdose, predose on Days 2, 3, 4, 5, 6, and on Day 7 predose (within 30 minutes prior to study drug administration) and 0.25, 0.5, 1,|All subjects who received at least one dose in Part B|||h*ng/mL||Full Range|Mean
2541507|NCT03022799|Secondary|Vz/F (Apparent Volume of Distribution)|To evaluate Vz/F of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects multiple oral doses of KM-819 in elderly male subjects.|Part A: Day 1 to 4; Part B: Day 1 to Day 8|All subjects who received at least one dose.|||mL||Geometric Coefficient of Variation|Geometric Mean
2541508|NCT03022799|Secondary|CL/F (Apparent Oral Clearance)|To evaluate the CL/F of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.|Part A: Day 1 to 4; Part B: Day 1 to Day 8|All subjects who received at least one dose.|||mL/h||Geometric Coefficient of Variation|Geometric Mean
2541509|NCT03022799|Secondary|%AUCex (Percentage of AUCinf That is Due to Extrapolation Beyond Tlast)|To evaluate %AUCex of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.|Part A: Day 1 to 4; Part B: Day 1 to Day 8|All subjects who received at least one dose.|||percentage of AUC||Geometric Coefficient of Variation|Geometric Mean
2541510|NCT03022799|Secondary|AUCinf (Area Under the Plasma Concentration-time Curve From Predose (Time 0) Extrapolated to Infinity)|To evaluate AUCinf of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male-subjects.|Part A: Day 1 to 4; Part B: Day 1 to Day 8|All subjects who received at least one dose.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2541511|NCT03022799|Secondary|AUClast (Area Under the Plasma Concentration-time From Predose (Time 0) to the Last Quantifiable Concentration)|To evaluate AUClast of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.|Part A: Day 1 to 4; Part B: Day 1 to Day 8|All subjects who received at least one dose.|||h*ng/mL||Standard Deviation|Mean
2541512|NCT03022799|Secondary|Tlag (Lag Time)|To evaluate the T lag of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.|Part A: Day1 to Day 4. Part B: Day 1 to Day 8|All subjects who received at least one dose.|||Hours||Standard Deviation|Mean
2541513|NCT03022799|Secondary|t½ (Apparent Terminal Elimination Half Life)|To evaluate the pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects. To evaluate the PK and PD of single and multiple oral doses of KM-819 in elderly male subjects.|Part A: Day 1 to Day 4. Part B: Day1 to Day 8|All subjects who received at least one dose|||Hours||Geometric Coefficient of Variation|Geometric Mean
2541575|NCT03021538|Primary|Need for Blood Transfusion|Number of pRBC transfusion that resulted due to postoperative bleeding|72 hours after surgery||||number of pRBC transfusions||Standard Deviation|Mean
2541515|NCT03022799|Secondary|Cmax (Maximum Plasma Concentration Determined Directly From the Concentration-time Profile)|To evaluate Cmax of single and multiple ascending oral doses of KM-819 in healthy young adult male subjects and multiple oral doses of KM-819 in elderly male subjects.|Part A: Day1 to Day 4. Part B: Day-1 to Day 8|All subjects who received at least one dose.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2541516|NCT03022799|Primary|Number of Participants With Adverse Events|"All AEs will be coded using the latest available version 19.1 of the Medical Dictionary for Regulatory Activities (MedDRA).~A treatment-emergent adverse event (TEAE) is defined as an AE that begins or that worsens in severity after at least one dose of the study drug has been administered."|From screening (Day-28 to Day -2), Day -1 to Day 4, Day 7, and follow-up visit Day 14.|All subjects who received at least one dose.|||participants|||Number
2541517|NCT03022630|Secondary|Provider Satisfaction|"The ICU Provider Satisfaction Survey with the Palliative Care Program:Veterans Affairs of Ann Arbor instrument is available online and has been modified for the current study by removing the 'ICU' reference and revising 'pain' to symptoms more relevant to the current population. The survey includes 7-item questionnaire, with items scored on a 5-point Likert type scale with higher scores indicating better provider satisfaction. The score can range from 0 to 35.~Time frame was changed due to early termination. Data was not collected."|Change from Baseline to study closeout.|The provider population was not analyzed because data was not collected.||||||
2541518|NCT03022630|Secondary|Survival|Survival rate compared across arms. Time frame was changed from 1 year to 6 months due to early termination.|6 months post-randomization|5 participants withdrew from the usual hepatic care group.|||Participants|||Count of Participants
2541519|NCT03022630|Secondary|Presence of Advance Directives|"Percentage of patients with documented advance care directives compared across arms.~Time frame was changed from 1 year to 6 months due to early termination."|6 months post-randomization|5 participants withdrew from the usual hepatic care group.|||Participants|||Count of Participants
2541520|NCT03022630|Secondary|Physical Symptoms|"Number of documented physical symptoms (ascites, variceal bleeding, encephalopathy, etc.) compared across arms.~Time frame was changed from 1 year to 6 months due to early termination. Physical symptom data was not obtained."|6 months post-randomization|Physical symptom data was not obtained.||||||
2541521|NCT03022630|Secondary|Completed Liver Transplants|Number of patients with completed liver transplants compared across arms. Time frame was changed from 1 year to 6 months due to early termination.|6 months post-randomization|5 participants withdrew from the usual hepatic care group.|||Participants|||Count of Participants
2541522|NCT03022630|Secondary|Model for End-Stage Liver Disease (MELD) Score|Baseline MELD score compared across arms. MELD score ranks the participants degree of sickness and indicates how much the participant needs a liver transplant. The score ranges from 6-40. The higher the number the more urgent the need for a transplant.|Baseline|Baseline MELD scores were only available for 26 intervention group participants and 27 control group participants.|||score on a scale||Inter-Quartile Range|Median
2541523|NCT03022630|Secondary|Liver Transplant Status|"Number of deferred, listed, and declined listing for liver transplant compared across arms.~Time frame was changed from 1 year to 6 months due to early termination. Liver transplant status data was not obtained."|6 months post-randomization|Liver transplant status data was not obtained.||||||
2541524|NCT03022630|Secondary|Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient Adapted for Caregiver)|"Change in caregiver satisfaction with care: The Quality of End-of-Life Care: Questionnaire for Patient item wording was modified to apply to caregivers. The questionnaire is an 11-item questionnaire, with items scored on a 10-point Likert type scale with higher scores indicating better quality of care. The score can range from 0 to 110.~Time frame was changed from 1 year to 6 months due to early termination."|Change from baseline over 6 months post-randomization|The intended population includes the caregivers. Only one caregiver in each group returned both surveys.|||score on a scale||Inter-Quartile Range|Median
2541525|NCT03022630|Secondary|Change in Kingston Caregiver Stress Scale|"The Kingston Caregiver Stress Scale will be used to measure caregiver stress. The KCSS is designed to measure stress experienced by lay caregivers, not institutional staff, and was designed to monitor change in an individuals stress over time. Ten items are grouped into three categories: care giving, family, and financial issues. Scores can range from 10 to 50. Lower scores indicate less stress and higher scores indicate high stress.~Time frame was changed from 1 year to 6 months due to early termination."|Change from baseline over 6 months post-randomization|The intended population included caregivers. There is no statistics to report. The two scores from participants in the intervention group are indicated below.|||Participants|||Count of Participants
2541526|NCT03022630|Secondary|Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient)|"Change in patient satisfaction with care: The Quality of End-of-Life Care: Questionnaire for Patient is an 11-item questionnaire, with items scored on a 10-point Likert type scale with higher scores indicating better satisfaction with care. The score can range from 0 to 110.~Time frame was changed from 1 year to 6 months due to early termination."|Change from baseline over 6 months post-randomization|Only 5 participants from the comprehensive palliative care services each group and 4 participants from the usual hepatic care group returned both baseline and 6-month surveys.|||score on a scale||Inter-Quartile Range|Median
2541527|NCT03022630|Secondary|Change in PROMIS Emotional Distress - Depression - Short Form 4a|"Change in mood (depression): The PROMIS Emotional Distress - Depression - Short Form 4a contains 4 items that measure depression on a 5-point Likert scale with higher scores indicating increased symptomatology. The raw score ranges from 4 to 20 which converts to a t-score range of 41.0 to 79.4.~Time frame was changed from 1 year to 6 months due to early termination."|Change from baseline over 6 months post-randomization|Only 4 participants from the comprehensive palliative care services each group and 5 participants from the usual hepatic care group returned both baseline and 6-month surveys.|||score on a scale||Inter-Quartile Range|Median
2541528|NCT03022630|Secondary|Change in PROMIS Emotional Distress - Anxiety - Short Form 4a|"Change in mood (anxiety): The PROMIS Emotional Distress - Anxiety - Short Form 4a contains 4 items that measure anxiety on a 5-point Likert scale with higher scores indicating increased symptomatology. The raw score can range from 4 to 20 which converts to a t-score range of 40.3 to 81.6.~Time frame was changed from 1 year to 6 months due to early termination."|Change from baseline over 6 months post-randomization|Only 5 participants from each group returned both baseline and 6-month surveys.|||score on a scale||Inter-Quartile Range|Median
2541529|NCT03022630|Secondary|Change in EQ-5D-5L|"Change in generic health status: The EQ-5D-5L is a 5-item questionnaire with responses ranging from absence of symptom to extreme experience of the symptom. This scale is numbered from 0 to 100. 100 means the best health you can imagine and 0 means the worst health you can imagine.~Time frame was changed from 1 year to 6 months due to early termination."|Change from baseline over 6 months post-randomization|Only 5 participants from each group returned both baseline and 6-month surveys.|||score on a scale||Inter-Quartile Range|Median
2541530|NCT03022630|Secondary|Change in Chronic Liver Disease Questionnaire (CLDQ)|"Change in liver disease-related quality of life: The CLDQ is a 29-item questionnaire measuring 6 domains. Item scores range from 1 to 7 with higher scores indicating better quality of life. The total score can range from 29 to 203 with a score of 1 meaning the symptom being assessed is present always while a score of 7 means the symptom is never present. Therefore, a higher score corresponds to a better quality of life while a lower score corresponds to a worse quality of life. The questions in each domain have a range of factor loads indicative of their impact, and a clinically important difference is defined as a score change of 0.5.~Time frame was changed from 1 year to 6 months due to early termination."|Change from baseline over 6 months post-randomization|Only 5 participants in each group returned both the baseline and 6-month surveys.|||score on a scale||Inter-Quartile Range|Median
2541531|NCT03022630|Secondary|Time to Hospice Placement|Number of days from hospice referral to time to hospice placement. Time frame was changed from 1 year to 6 months due to early termination. There are only 3 patients with a hospice admission date that is after baseline discharge, all of whom are from the control group. The remaining patients with hospice referral but are missing a hospice admission date due to death before hospice admission. Therefore, it is not feasible to calculate any statistics.|6 months post-randomization|There are only 3 patients with a hospice admission date that is after baseline discharge, all of whom are from the control group. The remaining patients with hospice referral but are missing a hospice admission date due to death before hospice admission. Therefore, it is not feasible to calculate any statistics.|||Participants|||Count of Participants
2541532|NCT03022630|Secondary|Hospice Referral|"Number of transfers to hospice within 6 months post randomization compared across arms.~Time frame was changed from 1 year to 6 months due to early termination."|6 months post-randomization|5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.|||Participants|||Count of Participants
2541533|NCT03022630|Secondary|Median Length of Hospital Stay Per Admission|"Median length of hospital stay per admission from randomization to 6 months post randomization compared across arms.~Time frame was changed from 1 year to 6 months due to early termination."|6 months post-randomization|The sample size indicates number of hospital readmissions per study arm.|||days per admission||Inter-Quartile Range|Median
2541534|NCT03022630|Secondary|Number of Hospital Readmissions|"Number of hospital readmissions from randomization to 6 months post randomization compared across arms.~Time frame was changed from 1 year to 6 months due to early termination."|6 months post-randomization|5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.|||Participants|||Count of Participants
2541535|NCT03022630|Secondary|Total Days in ICU|"Total days in ICU from randomization to 6 months post randomization compared across arms.~Time frame was changed from 1 year to 6 months due to early termination."|6 months post-randomization|5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.|||Participants|||Count of Participants
2541536|NCT03022630|Secondary|Total Days in Hospital|Total days in hospital from randomization to 6 months post randomization compared across arms Time frame was changed from 1 year to 6 months due to early termination.|6 months post-randomization|5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.|||days||Inter-Quartile Range|Median
2541537|NCT03022630|Secondary|Days Alive Out of Hospital|"Days alive out of hospital from randomization to 6 months post randomization compared across arms.~Time frame was changed from 1 year to 6 months due to early termination."|6 months post-randomization|5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.|||days||Inter-Quartile Range|Median
2541538|NCT03022630|Primary|Time to First Hospital Readmission Within 6 Months Post-randomization|"Assess the impact of palliative care services on time to first hospital readmission.~Time frame was changed from 1 year to 6 months due to early termination."|6 months post-randomization|5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.|||days||Inter-Quartile Range|Median
2541539|NCT03022435|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization||||Participants|||Count of Participants
2541540|NCT03022435|Primary|Number of Participants Who Received Influenza Vaccine||Day 0||||Participants|||Count of Participants
2541541|NCT03022422|Secondary|Number of Individual Twins With Related Adverse Events||Day 0 to 28 post-immunization||||Participants|||Count of Participants
2541542|NCT03022422|Primary|Number of Individual Twins Who Received Influenza Vaccine||Day 0||||Participants|||Count of Participants
2541543|NCT03022396|Secondary|Number of Individual Twins With Related Adverse Events||Day 0 to 28 post-immunization||||Participants|||Count of Participants
2541544|NCT03022396|Primary|Number of Individual Twins Who Received Influenza Vaccine|All numbers reported are the number of participants, not the number of twin pairs. Each member of a twin was counted individually as a participant.|Day 0 to 28|All numbers reported are the number of participants, not the number of twin pairs. Each member of a twin was counted individually as a participant.|||Participants|||Count of Participants
2541545|NCT03022045|Secondary|Percentage of Participants With EP Achieving PASI90 at Week 52|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.|Week 52||2022-01-31|01/2022||||
2553523|NCT02774798|Secondary|Squeeze Opening Pressure|the pressure (cmH2O) at whihc the anal canal opens during volunatry anal contraction|at specific time point of measurement up to 1 hour||||cmH2O||Standard Deviation|Mean
2541546|NCT03022045|Secondary|Percentage of Participants With GPP Achieving PASI90 at Week 52|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.|Week 52||2022-01-31|01/2022||||
2541547|NCT03022045|Secondary|Percentage of Participants With EP Achieving PASI90 at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 16||||percentage of participants|||Number
2541548|NCT03022045|Secondary|Percentage of Participants With GPP Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.|Week 16||||percentage of participants|||Number
2541549|NCT03022045|Secondary|Percentage of Participants With EP Achieving EP Clinical Response at Week 52|"EP Clinical Response, defined as at least Minimally Improved in CGI-GI for EP. The CGI-GI is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-GI ratings are as follows: 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse)."|Week 52||2022-01-31|01/2022||||
2541550|NCT03022045|Secondary|Percentage of Participants With GPP Achieving GPP Clinical Response at Week 52|"GPP Clinical Response defined as at least Slightly Improved in the overall improvement rating from baseline according to JDA total score for GPP. The JDA consists of an assessment of skin symptoms (area of skin with erythema, pustules, and edema) on a scale of 0 (none) to 9 (severe) and a systemic symptoms/assessment of test findings (fever, WBC, serum CRP, and serum albumin) on a scale of 0 (none) to 8 (severe). The JDA total score is the sum of the 2 assessments ranging from 0 (mild) to 17 (severe). The overall improvement rating ranges from Markedly improved (decreased by ≥ 3 points) to Worsened (increased by ≥ 1 point); Slightly improved represents no change in points and ≥ 20% and < 30% reduction of erythema area with pustules compared to baseline, or clinically meaningful improvement in ≥1 other parameters of the severity assessment criteria."|Week 52||2022-01-31|01/2022||||
2541551|NCT03022045|Primary|Percentage of Participants With Erythrodermic Psoriasis (EP) Achieving EP Clinical Response at Week 16|"EP Clinical Response, defined as at least Minimally Improved in Clinical Global Impression-Global Improvement (CGI-GI) for EP. The CGI-GI is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-GI ratings are as follows: 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse). NRI was used for missing data."|Week 16||||percentage of participants|||Number
2541552|NCT03022045|Primary|Percentage of Participants With Generalized Pustular Psoriasis (GPP) Achieving GPP Clinical Response at Week 16|"GPP Clinical Response defined as at least Slightly Improved in the overall improvement rating from baseline according to Japanese Dermatological Association (JDA) total score for GPP. The JDA consists of an assessment of skin symptoms (area of skin with erythema, pustules, and edema) on a scale of 0 (none) to 9 (severe) and a systemic symptoms/assessment of test findings (fever, white blood count [WBC], serum C-reactive protein [CRP], and serum albumin) on a scale of 0 (none) to 8 (severe). The JDA total score is the sum of the 2 assessments ranging from 0 (mild) to 17 (severe). The overall improvement rating ranges from Markedly improved (decreased by ≥ 3 points) to Worsened (increased by ≥ 1 point); Slightly improved represents no change in points and ≥ 20% and < 30% reduction of erythema area with pustules compared to baseline, or clinically meaningful improvement in ≥1 other parameters of the severity assessment criteria. Nonresponder imputation (NRI) was used for missing data."|Week 16||||percentage of participants|||Number
2541553|NCT03021759|Primary|Statin Prescribing Rate|Percentage of patients eligible for a statin that have been prescribed a statin|Two Months||||Participants|||Count of Participants
2541554|NCT03021668|Secondary|30-d Readmission|Need for 30-day readmission|Within 30 days of surgery||||Participants|||Count of Participants
2541555|NCT03021668|Secondary|Rate of Readmission for Surgical Site Infections (SSIs)|Any readmission for surgical site infections (SSIs) related to the surgery within the first 30 days after surgery|Within 30 days of operation||||Participants|||Count of Participants
2541556|NCT03021668|Secondary|Prolonged Length of Stay, Measured in Days|Length of stay of patient at the hospital from date of surgery|Within 10 days of surgery||||days||Inter-Quartile Range|Median
2541557|NCT03021668|Primary|Rate of Surgical Site Infection|Surgical site infection will be diagnosed and classified based on the World Health Organization definition into superficial Infection (involving only skin and subcutaneous tissue of incision), deep incisional (involving deep tissues) or organ/space (involving organs and spaces other than the incision which was opened or manipulated during operation)|Within 30 days of the operation||||Participants|||Count of Participants
2541701|NCT03020576|Secondary|Change in Range of Motion Measures|quantitative assessment of the mobility of joints throughout the upper limb using standard goniometric measures. Measured in degrees (0-360 degrees)|Through study completion, an average of 8 weeks||||change in units on a scale||Standard Deviation|Mean
2541558|NCT03021642|Secondary|Number of Subjects With Clinically Significant Change From Baseline in Vital Signs, Electrocardiogram (ECG) and Laboratory Parameters|Number of subjects with clinically significant change from baseline in vital signs, ECG and laboratory parameters were reported. Clinical Significance was decided by the investigator. Vital signs included oral body temperature, systolic blood pressure, diastolic blood pressure, and pulse rate. The 12-lead ECGs were recorded after the subjects have rested for at least 5 minutes in supine position. The parameters included heart rate (HR), RR, PR, QRS, QT and QTcB calculated by the Bazett formula. Laboratory investigation included hematology, biochemistry, urinalysis, and coagulation.|Baseline up to end of trial (up to Day 43)|SAF population. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment. Thus, number of subjects analyzed per treatment is mentioned as 23.|||Participants|||Count of Participants
2541559|NCT03021642|Secondary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug.|Baseline up to end of trial (up to Day 43)|SAF population. A total of 24 subjects were evaluated for adverse events. Because 1 subject in each treatment sequence discontinued before receiving the second treatment, only 23 subjects received Test Treatment and 23 subjects received Reference Treatment.Thus, number of subjects analyzed per treatment is mentioned as 23.|||Participants|||Count of Participants
2541560|NCT03021642|Secondary|Ratio of Maximum Plasma Concentration Observed (Cmax) of Metabolite (MSC2571109A or MSC2571107A) to Cmax of Tepotinib|Ratio of Cmax of metabolite (MSC2571109A or MSC2571107A) to Cmax of tepotinib was reported.|Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2|The PK analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2541561|NCT03021642|Secondary|Ratio of Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Metabolite (MSC2571109A or MSC2571107A) to AUC0-inf of Tepotinib|Ratio of AUC0-inf of Metabolite (MSC2571109A or MSC2571107A) to AUC0-inf of tepotinib was reported.|Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2|"The PK analysis set. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure and Number Analyzed signifies those subjects who were evaluable for specified category."|||ratio||Geometric Coefficient of Variation|Geometric Mean
2541562|NCT03021642|Secondary|Extrapolated Area Under the Plasma Concentration-Time Curve From Time t to Infinity (%AUCextra) of Tepotinib and Metabolites (MSC2571109A and MSC2571107A)|%AUCextra was defined as a percentage of AUC0-inf obtained by extrapolation: %AUCextra = (1- [AUC0-t / AUC0-inf])*100. %AUCextra was reported in terms of percentage of AUC0-inf.|Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2|"The PK analysis set. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure and Number Analyzed signifies those subjects who were evaluable for specified category."|||percentage of AUC0-inf||Geometric Coefficient of Variation|Geometric Mean
2541563|NCT03021642|Secondary|Apparent Volume of Distribution (Vz/f) for Tepotinib|Vz/f is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/f during the terminal phase was reported.|Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2|The PK analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure.|||liters||Geometric Coefficient of Variation|Geometric Mean
2541564|NCT03021642|Secondary|Total Body Clearance of Drug From Plasma (CL/f) for Tepotinib|CL/f following oral administration was calculated as Dose/AUC0-inf, where AUC0-inf calculated as AUC0-t + AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clastcalc/λz, where Clastcalc was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the LLOQ and λz was the apparent terminal rate constant determined from the terminal slope of the log-transformed plasma concentration curve.|Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2|The PK analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure.|||liter/hour||Geometric Coefficient of Variation|Geometric Mean
2541565|NCT03021642|Secondary|Apparent Terminal Rate Constant (λz) of Tepotinib and Metabolites (MSC2571109A and MSC2571107A) in Plasma|Apparent terminal rate constant was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.|Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2|"The PK analysis set. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure and Number Analyzed signifies those subjects who were evaluable for specified category."|||1/h||Geometric Coefficient of Variation|Geometric Mean
2541566|NCT03021642|Secondary|Apparent Terminal Half-Life (t1/2) of Tepotinib and Metabolites (MSC2571109A and MSC2571107A) in Plasma|t1/2 was defined as the time taken for the plasma concentration or the amount of drug in the body to be reduced by half.|Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2|"The PK analysis set. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure and Number Analyzed signifies those subjects who were evaluable for specified category."|||hours||Geometric Coefficient of Variation|Geometric Mean
2541567|NCT03021642|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Tepotinib Metabolites (MSC2571109A and MSC2571107A)|Tmax was obtained directly from the concentration versus time curve.|Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2|The PK analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure.|||hours||Full Range|Median
2541568|NCT03021642|Secondary|Maximum Plasma Concentration Observed (Cmax) of Tepotinib Metabolites (MSC2571109A and MSC2571107A)|Cmax was obtained directly from the concentration versus time curve.|Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2|The PK analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2541569|NCT03021642|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tepotinib Metabolites (MSC2571109A and MSC2571107A)|AUC0-inf was calculated as AUC0-t + AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clastcalc/λz, where Clastcalc was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the LLOQ and λz was the apparent terminal rate constant determined from the terminal slope of the log-transformed plasma concentration curve.|Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2|"The PK analysis set. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure and Number Analyzed signifies those subjects who were evaluable for specified category."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2541570|NCT03021642|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t) of Tepotinib Metabolites (MSC2571109A and MSC2571107A)|AUC0-t at which the concentration was at or above LLOQ was calculated according to the mixed log linear trapezoidal rule.|Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2|The PK analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2541571|NCT03021642|Primary|Time to Reach the Maximum Plasma Concentration (Tmax) of Tepotinib|Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.|Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2|The PK analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure.|||hours||Full Range|Median
2541572|NCT03021642|Primary|Maximum Plasma Concentration Observed (Cmax) of Tepotinib|Cmax was obtained directly from the concentration versus time curve.|Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2|The PK analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2541573|NCT03021642|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tepotinib|AUC0-inf was calculated as AUC0-t + AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clastcalc/λz, where Clastcalc was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the LLOQ and λz was the apparent terminal rate constant determined from the terminal slope of the log-transformed plasma concentration curve.|Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2|The PK analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here 'Overall number of participants analyzed' = overall number of subjects evaluable for this outcome measure.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2541574|NCT03021642|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t) at Concentration at or Above Lower Limit of Quantitation (LLOQ) of Tepotinib|AUC0-t was calculated according to the mixed log linear trapezoidal rule.|Pre-dose, 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 16, 24, 30, 36, 48, 54, 60, 72, 96, 120, 144, 168, 216, 288, 336, and 504 hours post-dose during Treatment Periods 1 and 2|The pharmacokinetic (PK) analysis set included all subjects who received at least 1 dose of IMP and had at least 1 post-dose PK measurement without important protocol deviations/violations or events that could have affected the PK. Here ‘Overall number of participants analyzed’ = overall number of subjects evaluable for this outcome measure.|||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2541576|NCT03021343|Primary|The Number of Participants With Colchicine Side Effects|The primary safety endpoint was the occurrence of side effects. Side effects monitored were mainly gastrointestinal effects (especially diarrhoea), alopecia, anorexia, hepatotoxicity, myotoxicity, and bone marrow toxicity.|From date of randomization until the date of discharge, assessed up to 2 weeks||||participants|||Number
2541577|NCT03021343|Primary|The Number of Participants With Atrial Fibrillation|The primary efficacy end point was the rate of AF in both arms. AF lasting more than 5 minutes were considered significant|From date of randomization until the date of discharge, assessed up to 2 weeks||||Participants|||Count of Participants
2541578|NCT03021304|Secondary|Percentage of Participants With Successful Self-administration of Their Unobserved Second Dose Outside the Clinic Setting at Week 4|The participant (or caregiver), self-administered the dose of study treatment outside the clinic and without observation during Week 4, up to 24 hours after attending clinic Visit 3. The 'self-administration' was defined as either administration of mepolizumab liquid drug product in safety syringe by the participants themselves or by their caregiver. The participant/caregiver completed an 'At home Checklist' outlining the various steps in the IFU to use the safety syringe. On returning to clinic the investigator inspected whether the returned safety syringe showed any signs that the full dose had not been administered.|Week 4|All Subjects (Safety) Population|||Percentage of participants|||Number
2541579|NCT03021304|Primary|Percentage of Participants With Successful Self-administration of Their Observed Third Dose at Week 8|During the clinic visits the Investigator or designee evaluated if the participants were able to self-administer the third dose at Week 8 by visual inspection immediately following injection and by using an 'Observer checklist' based on the safety syringe Instructions for Use (IFU). The 'self-administration' was defined as administration of mepolizumab liquid drug product in safety syringe either by the participants themselves or by their caregiver. Failure to perform one of the critical steps was deemed to be failure to successfully administer the injection. Participants with data available at Week 8 have been analyzed. Analysis was performed on All Subjects (Safety) Population which comprised of all enrolled participants attempting at least one self administration of mepolizumab liquid drug product in a safety syringe.|Week 8|All Subjects (Safety) Population|||Percentage of participants|||Number
2541580|NCT03021187|Secondary|Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed)|"Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26 and week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction."|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2541581|NCT03021187|Secondary|Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains|The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. The items of the IWQOL-Lite-CT pertain to physical functioning (physical, physical function and pain/discomfort) and psychosocial domains and all items employ a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2541582|NCT03021187|Secondary|Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)|SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2541583|NCT03021187|Secondary|Semaglutide Plasma Concentrations for Population PK Analyses|This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Semaglutide plasma concentrations were measured at week 4, 14, 26, 38 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Weeks 0-52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2541621|NCT03021018|Secondary|Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 8 Hours After the End of Study Drug Administration|This variable was defined as the number of subjects seizure free during 8 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100.|At 8 hours after the end of study drug administration|The Intent‑to‑Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.|||percentage of participants|||Number
2541584|NCT03021187|Secondary|Change in Eye Examination Category|Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week -2, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541585|NCT03021187|Secondary|Change in Physical Examination|Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2) and weeks 52 presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.|Week -2, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541586|NCT03021187|Secondary|Change in ECG Evaluation|Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. Change from baseline results are presented as shift in findings (normal; abnormal and not clinically significant (NCS); abnormal and clinically significant (CS)) from week 0 to week 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541587|NCT03021187|Secondary|Change in SBP and DBP|Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||mmHg||Standard Deviation|Mean
2541588|NCT03021187|Secondary|Change in Pulse Rate|Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52 Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Beats/minute||Standard Deviation|Mean
2541589|NCT03021187|Secondary|Change in Lipase - Ratio to Baseline|Change from baseline (week 0) in lipase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Ratio of lipase||Geometric Coefficient of Variation|Geometric Mean
2541590|NCT03021187|Secondary|Change in Amylase - Ratio to Baseline|Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Ratio of amylase||Geometric Coefficient of Variation|Geometric Mean
2541591|NCT03021187|Secondary|Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes|Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Weeks 0-57|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Participants|||Count of Participants
2541592|NCT03021187|Secondary|Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes|Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Weeks 0-57|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Episodes|||Number
2542117|NCT03007966|Secondary|Post-operative Verbal Pain Score With Activity|Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome|24hrs Post Nerve Block||||score on a scale||Standard Deviation|Mean
2541593|NCT03021187|Secondary|Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product|Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Weeks 0-57|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.|||Events|||Number
2541594|NCT03021187|Secondary|Time to Rescue Medication|Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 1) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Weeks 0-52|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2541595|NCT03021187|Secondary|Time to Additional Anti-diabetic Medication|Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as use of new anti-diabetic medication for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-52|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2541596|NCT03021187|Secondary|Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)|Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541597|NCT03021187|Secondary|Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)|Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541598|NCT03021187|Secondary|Participants Who Achieve Body Weight Loss ≥10% (Yes/no)|Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. Results are based on the data from the in-trial observation period, which started at the date of randomisation and included the period after initiatiion of of rescue medication and/or premature trial product discontinuation, if any.|Week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541599|NCT03021187|Secondary|Participants Who Achieve Body Weight Loss ≥5% (Yes/no)|Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.|Week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541600|NCT03021187|Secondary|Participants Who Achieve: HbA1c ≤ 6.5% (48 mmol/Mol) (AACE Target) (Yes/no)|Number of participants achieving HbA1c ≤ 6.5% (48 mmol/mol) according to American Association of Clinical Endocrinologists (AACE) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.|Week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541672|NCT03020745|Primary|Part 2: Change From Baseline in Complement Bb Level at Indicated Time Points|Blood samples were collected from participants to assess complement Bb levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose) and Up to Day 169|Safety Population|||Milligram per liter||Standard Deviation|Mean
2541601|NCT03021187|Secondary|Participants Who Achieve: HbA1c < 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)|Number of particpants achieving HbA1c < 7.0 % (53 mmol/mol) according to American Diabetes Association (ADA) target, at week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.|Week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541602|NCT03021187|Secondary|Change in Total Daily Insulin Dose|Change from baseline in total daily insulin dose to week 26 and week 52 is presented. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Units/day||Standard Deviation|Mean
2541603|NCT03021187|Secondary|Change in Triglycerides - Ratio to Baseline|Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of triglycerides||Geometric Coefficient of Variation|Geometric Mean
2541604|NCT03021187|Secondary|Change in HDL Cholesterol - Ratio to Baseline|Change from baseline (week 0) in HDL cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of HDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2541605|NCT03021187|Secondary|Change in LDL Cholesterol - Ratio to Baseline|Change from baseline in LDL cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of LDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2541606|NCT03021187|Secondary|Change in Total Cholesterol - Ratio to Baseline|Change from baseline in total cholesterol (mmol/L) is presented as ratio to baseline at week 26 and week 52. Results are based on the data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of total cholesterol||Geometric Coefficient of Variation|Geometric Mean
2541607|NCT03021187|Secondary|Change in Waist Circumference|Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||cm||Standard Deviation|Mean
2541608|NCT03021187|Secondary|Change in Body Mass Index|Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26 and 52. BMI was calculated based on body weight and height based on the formula: BMI kg/m^2 = body weight (kg)/(Height (m) x Height (m)). Data based on in-trial observation period is presented. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||kg/m^2||Standard Deviation|Mean
2541609|NCT03021187|Secondary|Change in Body Weight (Percentage)|Relative change from baseline (week 0) in body weight (%) was evaluated at weeks 26 and 52.The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Percentage change||Standard Deviation|Mean
2541610|NCT03021187|Secondary|Change in SMPG Mean Postprandial Increment Over All Meals|Change from baseline (week 0) in SMPG mean postprandial increment over all meals to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2541622|NCT03021018|Secondary|Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 6 Hours After the End of Study Drug Administration|This variable was defined as the number of subjects seizure free during 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat (ITT) set multiplied by 100.|At 6 hours after the end of study drug administration|The Intent‑to‑Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.|||percentage of participants|||Number
2553590|NCT02773836|Primary|Number of Participants Who Have Ever Tried to Quit Smoking|"Have you ever tried to quit smoking?~Yes~No~8 Refused 9 Don't know"|Baseline Pre-TPD||||Participants|||Count of Participants
2541611|NCT03021187|Secondary|Change in Self-measured Plasma Glucose (SMPG) Mean 7-point Profile|Change from baseline (week 0) in self-measured plasma glucose (SMPG) mean 7-point profile to week 26 and week 52. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2541612|NCT03021187|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline (week 0) in FPG to week 26 and week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2541613|NCT03021187|Secondary|Change in Body Weight (kg) (Week 52)|Change from baseline (week 0) in body weight to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.|Week 0, week 52|Overall number of participants analyzed = number of participants with available data.|||Kg||Standard Deviation|Mean
2541614|NCT03021187|Secondary|Change in HbA1c (Week 52)|Change from baseline (week 0) in HbA1c to week 52. The endpoint was evaluated based on data from the in-trial observation period. In trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any.|Week 0, week 52|Overall number of participants analyzed = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2541615|NCT03021187|Secondary|Change in Body Weight (Week 26)|Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also evaluated based on data from the on-treatment without rescue medication observation period. It started at the date of first dose of trial product and excluded the period after initiation of rescue medication and/or premature trial product discontinuation, if any.|Week 0, week 26|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Kg||Standard Deviation|Mean
2541616|NCT03021187|Primary|Change in HbA1c (Week 26)|Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period started at the date of the first dose of trial product and includes the period after initiation of rescue medication, if any, and excludes the period after premature trial discontinuation, if any.|Week 0, week 26|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2541617|NCT03021018|Secondary|Percentage of Subjects Who Receive Rescue Medication During the 12 Hours After the End of Study Drug Administration|This variable was defined as the number of subjects who received rescue medication with start date and time within the first 12 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100.|During the 12 hours after the end of study drug administration|The Intent‑to‑Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.|||percentage of participnats|||Number
2541618|NCT03021018|Secondary|Percentage of Subjects Who Receive Rescue Medication During the 8 Hours After the End of Study Drug Administration|This variable was defined as the number of subjects who received rescue medication with start date and time within the first 8 hours after the end of study drug administration divided by the number of subjects in the ITT-R set multiplied by 100.|During the 8 hours after the end of study drug administration|The Intent‑to‑Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.|||percentage of participants|||Number
2541619|NCT03021018|Secondary|Percentage of Subjects Who Receive Rescue Medication During the 6 Hours After the End of Study Drug Administration|This variable was defined as the number of subjects who received rescue medication with start date and time within the first 6 hours after the end of study drug administration divided by the number of subjects in the Intent-to-Treat as randomized (ITT-R) set multiplied by 100.|During the 6 hours after the end of study drug administration|The Intent‑to‑Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.|||percentage of participnats|||Number
2541620|NCT03021018|Secondary|Percentage of Subjects Who Are Seizure-free Per Clinical Observation at 12 Hours After the End of Study Drug Administration|This variable was defined as the number of subjects seizure free during 12 hours after the end of study drug administration divided by the number of subjects in the ITT set multiplied by 100.|At 12 hours after the end of study drug administration|The Intent‑to‑Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.|||percentage of participants|||Number
2541698|NCT03020576|Secondary|Change in Mobility and Activities of Daily Living|The Barthel Index is a quantitative scale measuring the need for assistance an individual has in performance of tasks of general mobility and activities of daily living. Maximum raw score is 100. Higher values represent better outcomes.|Through study completion (taken at baseline and at 8 week study completion)||||units on a scale||Standard Deviation|Mean
2541623|NCT03021018|Secondary|Time to Next Seizure (Per Clinical Observation) or Rescue Medication|This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed and not necessarily confirmed via electroencephalogram [EEG]) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.|During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)|The Intent‑to‑Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.|||hours||95% Confidence Interval|Median
2541624|NCT03021018|Primary|Time to Next Seizure (Per Clinical Observation With Electroencephalogram [EEG] Confirmation) or Rescue Medication|This variable was calculated in hours. The event of next seizure was defined as the first seizure (clinically observed with electroencephalogram [EEG] confirmation) with the start date and time within 12 hours after the end of investigational medicinal product (IMP) administration.|During the Treatment Period (Day 1) until Safety Follow-Up Visit (Day 2)|The Intent‑to‑Treat as Randomized (ITT-R) Set consisted of all randomized subjects who received the investigational medicinal product (IMP) for qualifying seizures.|||hours||95% Confidence Interval|Median
2541625|NCT03021005|Primary|Number of Participants Who Did HIV Testing|Number of participants who did the HIV testing (HIV testing rate) will be determined by a telephone follow-up at 1 month after the index emergency department visit (enrollment).|At 1 month post enrollment|39 participants in Self Testing Kit group and 26 participants in No Self Testing Kit group were lost to follow-up.|||Participants|||Count of Participants
2541626|NCT03020745|Secondary|Part 2: t1/2 of GSK3389404 Metabolite (ISIS 505358)|Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2541627|NCT03020745|Secondary|Part 1: t1/2 of GSK3389404 Metabolite (ISIS 505358)|Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2541628|NCT03020745|Secondary|Part 2: Tmax of GSK3389404 Metabolite (ISIS 505358)|Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Hours||Full Range|Median
2541629|NCT03020745|Secondary|Part 1: Tmax of GSK3389404 Metabolite (ISIS 505358)|Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Hours||Full Range|Median
2541630|NCT03020745|Secondary|Part 2: Cmax of GSK3389404 Metabolite (ISIS 505358)|Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2541631|NCT03020745|Secondary|Part 1: Cmax of GSK3389404 Metabolite (ISIS 505358)|Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2541632|NCT03020745|Secondary|Part 2: AUC(0-t) for Metabolite of GSK3389404 (ISIS 505358)|Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2541633|NCT03020745|Secondary|Part 1: AUC(0-t) for Metabolite of GSK3389404 (ISIS 505358)|Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30|Pharmacokinetic Population|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2541634|NCT03020745|Secondary|Part 2: Change From Baseline in log10 HBeAg Levels in Plasma at Indicated Time Points|Blood samples were collected from participants to assess HBeAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).|Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169|ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Log10 (IU/mL)||Standard Deviation|Mean
2541635|NCT03020745|Secondary|Part 1: Change From Baseline in log10 Hepatitis B Virus E-antigen (HBeAg) Levels in Plasma at Indicated Time Points|Blood samples were collected from participants to assess HBeAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).|Baseline (Day 1 pre-dose) and Day 1: 8 hours, Days 3, 8, 15, 22, 30 and 60|Pharmacodynamic Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Log10 (IU/mL)||Standard Deviation|Mean
2541962|NCT03014700|Secondary|Count of Participants Who Died Within 30 Days Following Procedure||From administration of the drug to 30 days following surgery|Participants who completed the protocol are included in the analysis|||Participants|||Count of Participants
2541636|NCT03020745|Secondary|Part 2: Change From Baseline in log10 HBsAg Levels in Plasma at Indicated Time Points|Blood samples were collected from participants to assess HBsAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).|Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169|ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Log10 (IU/mL)||Standard Deviation|Mean
2541637|NCT03020745|Secondary|Part 1: Change From Baseline in log10 Hepatitis B Virus Surface Antigen (HBsAg) Levels in Plasma at Indicated Time Points|Blood samples were collected from participants to assess HBsAg levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).|Baseline (Day 1 pre-dose) and Day 1: 8 hours, Days 3, 8, 15, 22, 30 and 60|Pharmacodynamic Population|||Log10 (IU/mL)||Standard Deviation|Mean
2541638|NCT03020745|Secondary|Part 2: Change From Baseline in log10 HBV DNA Viral Load in Plasma at Indicated Time Points|Blood samples were collected from participants to assess HBV DNA viral load. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).|Baseline (Day 1 pre-dose) and Up to Day 169|ITT Population|||Log10 (IU/mL)||Standard Deviation|Mean
2541639|NCT03020745|Secondary|Part 1: Change From Baseline in log10 Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Viral Load in Plasma at Indicated Time Points|Blood samples were collected from participants to assess HBV DNA viral load. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Log10 change from Baseline was calculated as log10(Post-Dose Visit Value/Baseline).|Baseline (Day 1 pre-dose), Day 1: 8 hours, Days 3, 8, 15, 22, 30 and 60|Pharmacodynamic Population comprised of all participants in the Safety Population who provided evaluable pharmacodynamic data. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Log10 (IU/mL)||Standard Deviation|Mean
2541640|NCT03020745|Primary|Part 2: Number of Participants Achieving RR Based on Reduction of HBsAg Level From Baseline|The RR was based on the proportion of participants with at least a 1.5 log10 IU/mL reduction of HBsAg levels from Baseline at any time up to Day 85. Number of participants who achieved >1.5 log10 IU/mL decrease in HBsAg levels at any time up to Day 85 are presented.|Up to Day 85|ITT Population|||Participants|||Count of Participants
2541641|NCT03020745|Primary|Part 1: Number of Participants Achieving Response Rate (RR) Based on Reduction of Hepatitis B Surface Antigen (HBsAg) Level From Baseline|The RR was based on the proportion of participants with at least a 1.5 logarithm to the base 10 (log10) international units per milliliter (IU/mL) reduction of HBsAg levels from Baseline at any time up to Day 60. Number of participants who achieved >1.5 log10 IU/mL decrease in HBsAg levels at any time up to Day 60 are presented.|Up to Day 60|Intent-To-Treat (ITT) Population comprised of all randomized participants.|||Participants|||Count of Participants
2541642|NCT03020745|Primary|Part 2: CL/F of GSK3389404|Blood samples were collected to measure CL/F at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Liters per hour||95% Confidence Interval|Geometric Mean
2541643|NCT03020745|Primary|Part 1: Apparent Subcutaneous Plasma Clearance (CL/F) of GSK3389404|Blood samples were collected to measure CL/F at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Liters per hour||95% Confidence Interval|Geometric Mean
2541644|NCT03020745|Primary|Part 2: t1/2 of GSK3389404|Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2541645|NCT03020745|Primary|Part 1: Apparent Terminal Phase Half-life(t1/2) of GSK3389404|Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2541646|NCT03020745|Primary|Part 2: Tmax of GSK3389404|Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Hours||Full Range|Median
2541647|NCT03020745|Primary|Part 1: Time to Achieve Cmax (Tmax) of GSK3389404|Blood samples were collected to measure Tmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30|Pharmacokinetic Population|||Hours||Full Range|Median
2541648|NCT03020745|Primary|Part 2: Cmax of GSK3389404|Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2541649|NCT03020745|Primary|Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3389404|Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30|Pharmacokinetic Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2541650|NCT03020745|Primary|Part 2: AUC (0-infinity) for GSK3389404|Blood samples were collected to measure AUC (0-infinity) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2541651|NCT03020745|Primary|Part 1: Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-infinity]) for GSK3389404|Blood samples were collected to measure AUC (0-infinity) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2541652|NCT03020745|Primary|Part 2: AUC (0-t) for GSK3389404|Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose), Days 29 and 57 (Pre-dose and at 1, 2, 3 hours post-dose), Day 169|Pharmacokinetic Population. Only those participants with data available at the specified time points were analyzed.|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2541653|NCT03020745|Primary|Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Time of the Last Quantifiable Concentration (AUC[0-t]) for GSK3389404|Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Day 1 (Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 hours post-dose), Days 3, 8 and 30|Pharmacokinetic Population comprised of all participants in the Safety population for whom at least one evaluable pharmacokinetic sample were obtained and analyzed.|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2541654|NCT03020745|Primary|Part 2: Number of Participants With AEs and SAEs|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE.|Up to Day 169|Safety Population|||Participants|||Count of Participants
2541655|NCT03020745|Primary|Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE.|Up to Day 60|Safety Population|||Participants|||Count of Participants
2541656|NCT03020745|Primary|Part 2: Number of Participants With Abnormal ECG Findings|Electrocardiogram were obtained after 5 minutes of rest in the semi-supine or supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTcF intervals. CS and NCS abnormal ECG findings have been presented. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee.|Days 29, 57, 85 and 169|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2541657|NCT03020745|Primary|Part 1: Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Electrocardiograms were obtained after 5 minutes of rest in the semi-supine or supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee.|Day 1: 2 hours, Day 1: 4 hours, Day 1: 8 hours, Day 3, Day 8 and Day 30|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2541658|NCT03020745|Primary|Part 2: Change From Baseline in Urobilinogen at Indicated Time Points|Urine samples were collected from participants to assess urobilinogen levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Milligram per deciliter||Standard Deviation|Mean
2541659|NCT03020745|Primary|Part 1: Change From Baseline in Urobilinogen at Indicated Time Points|Urine samples were collected from participants to assess urobilinogen levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 3, 8, 30 and Follow-up (Day 60)|Safety Population|||Milligram per deciliter||Standard Deviation|Mean
2541660|NCT03020745|Primary|Part 2: Change From Baseline in Urine Specific Gravity at Indicated Time Points|Urine samples were collected from participants to assess urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Ratio||Standard Deviation|Mean
2541963|NCT03014700|Secondary|Length of Stay in Hospital||From administration of the drug during surgery to discharge from the hospital (up to 6 months)|Participants who completed the protocol are included in the analysis|||days||Inter-Quartile Range|Median
2541661|NCT03020745|Primary|Part 1: Change From Baseline in Urine Specific Gravity at Indicated Time Points|Urine samples were collected from participants to assess urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 3, 8, 30 and Follow-up (Day 60)|Safety Population|||Ratio||Standard Deviation|Mean
2541662|NCT03020745|Primary|Part 2: Change From Baseline in Urine pH at Indicated Time Points|Urine samples were collected from participants to assess urine pH levels. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||pH||Standard Deviation|Mean
2541663|NCT03020745|Primary|Part 1: Change From Baseline in Urine Potential of Hydrogen (pH) at Indicated Time Points|Urine samples were collected from participants to assess urine pH levels. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 3, 8, 30 and Follow-up (Day 60)|Safety Population|||pH||Standard Deviation|Mean
2541664|NCT03020745|Primary|Part 2: Change From Baseline in Urine Creatinine at Indicated Time Points|Urine samples were collected from participants to assess urine creatinine levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 15, 29, 43, 57, 71, 85, 92, 99, 113, 141 and 169|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2541665|NCT03020745|Primary|Part 1: Change From Baseline in Urine Creatinine at Indicated Time Points|Urine samples were collected from participants to assess urine creatinine levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 8, 30 and Follow-up (Day 60)|Safety Population|||Millimoles per liter||Standard Deviation|Mean
2541666|NCT03020745|Primary|Part 2: Change From Baseline in Urine Albumin at Indicated Time Points|Urine samples were collected from participants to assess urine albumin levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 15, 29, 43, 57, 71, 85, 92, 99, 113, 141 and 169|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Milligram per deciliter||Standard Deviation|Mean
2541667|NCT03020745|Primary|Part 1: Change From Baseline in Urine Albumin at Indicated Time Points|Urine samples were collected from participants to assess urine albumin levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 8, 30 and Follow-up (Day 60)|Safety Population|||Milligram per deciliter||Standard Deviation|Mean
2541668|NCT03020745|Primary|Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters|Blood samples were collected for the analysis of following clinical chemistry parameters: Alanine aminotransferase, Albumin, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Calcium (high), Calcium (low), Creatine kinase, Creatinine, Glucose (high), Glucose (low), Magnesium, Phosphate, Potassium (high), Potassium (low), Sodium (high), Sodium (low), Urate and glomerular filtration rate (GFR). Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those clinical chemistry parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented.|Up to Day 169|Safety Population|||Participants|||Count of Participants
2541669|NCT03020745|Primary|Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Clinical Chemistry Parameters|Blood samples were collected for the analysis of following clinical chemistry parameters: Alanine aminotransferase, Albumin, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Calcium (high), Calcium (low), Creatine kinase, Creatinine, Glucose (high), Glucose (low), Magnesium, Phosphate, Potassium (high), Potassium (low), Sodium (high), Sodium (low) and Urate. Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those clinical chemistry parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented.|Up to Day 60|Safety Population|||Participants|||Count of Participants
2541670|NCT03020745|Primary|Part 2: Change From Baseline in Complement C5a Level at Indicated Time Points|Blood samples were collected from participants to assess complement C5a levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose) and Up to Day 169|Safety Population|||Microgram per liter||Standard Deviation|Mean
2541671|NCT03020745|Primary|Part 1: Change From Baseline in Complement C5a Level at Indicated Time Points|Blood samples were collected from participants to assess complement C5a levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose) and Up to Day 60|Safety Population|||Microgram per liter||Standard Deviation|Mean
2541673|NCT03020745|Primary|Part 1: Change From Baseline in Complement Bb Level at Indicated Time Points|Blood samples were collected from participants to assess complement Bb levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose) and Up to Day 60|Safety Population|||Milligram per liter||Standard Deviation|Mean
2541674|NCT03020745|Primary|Part 2: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points|Blood samples were collected from participants to assess complement C3 and complement C4 levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose) and Up to Day 169|Safety Population|||Milligram per deciliter||Standard Deviation|Mean
2541675|NCT03020745|Primary|Part 1: Change From Baseline in Complement C3 and Complement C4 Level at Indicated Time Points|Blood samples were collected from participants to assess complement C3 and complement C4 levels. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose) and Up to Day 60|Safety Population|||Milligram per deciliter||Standard Deviation|Mean
2541676|NCT03020745|Primary|Part 2: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters|Blood samples were collected for the analysis of following hematology and coagulation parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils, Platelets, aPTT, Prothrombin INR and PT. Laboratory parameters were graded according to DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those hematology and coagulation parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented.|Up to Day 169|Safety Population|||Participants|||Count of Participants
2541677|NCT03020745|Primary|Part 1: Number of Participants With Maximum Post-Baseline Grade by Category in Hematology and Coagulation Parameters|Blood samples were collected for the analysis of following hematology and coagulation parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils, Platelets, Activated partial thromboplastin time (aPTT), Prothrombin international normalized ratio (INR) and Prothrombin time (PT). Laboratory parameters were graded according to Division of Acquired Immune Deficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Grade 1: mild; Grade 2: moderate; Grade 3: severe; and Grade 4: potentially life-threatening consequences. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Only those hematology and coagulation parameters with maximum post-Baseline grade (Grade 1 to Grade 4) have been presented.|Up to Day 60|Safety Population|||Participants|||Count of Participants
2541678|NCT03020745|Primary|Part 2: Number of Participants With Abnormal Findings in Physical Examination|Physical examinations included assessment of the dermatologic, cardiovascular, respiratory, gastrointestinal, and neurological systems. This analysis was not planned and data was not collected and not captured in the database.|Up to Day 169|Safety Population. This analysis was not planned and data was not collected and not captured in the database.||||||
2541679|NCT03020745|Primary|Part 1: Number of Participants With Abnormal Findings in Physical Examination|Physical examinations included assessment of the dermatologic, cardiovascular, respiratory, gastrointestinal, and neurological systems. This analysis was not planned and data was not collected and not captured in the database.|Up to Day 60|Safety Population. This analysis was not planned and data was not collected and not captured in the database.||||||
2541680|NCT03020745|Primary|Part 2: Change From Baseline in Body Temperature at Indicated Time Points|Body temperature was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Degrees Celsius||Standard Deviation|Mean
2541681|NCT03020745|Primary|Part 1: Change From Baseline in Body Temperature at Indicated Time Points|Body temperature was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 3, 8 and 30|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Degrees Celsius||Standard Deviation|Mean
2541682|NCT03020745|Primary|Part 2: Change From Baseline in Respiratory Rate at Indicated Time Points|Respiratory rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Breaths per minute||Standard Deviation|Mean
2541683|NCT03020745|Primary|Part 1: Change From Baseline in Respiratory Rate at Indicated Time Points|Respiratory rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 3, 8 and 30|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Breaths per minute||Standard Deviation|Mean
2541699|NCT03020576|Secondary|Change in Motor Activity Log Amount|quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.|Through study completion (taken at baseline and at 8-week study completion)||||units on a scale||Standard Deviation|Mean
2541684|NCT03020745|Primary|Part 2: Change From Baseline in Heart Rate at Indicated Time Points|Heart rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Beats per minute||Standard Deviation|Mean
2541685|NCT03020745|Primary|Part 1: Change From Baseline in Heart Rate at Indicated Time Points|Heart rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Day 1: 1 hour, Day 1: 2 hours, Day 1: 4 hours, Day 1: 8 hours, Day 3, Day 8 and Day 30|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Beats per minute||Standard Deviation|Mean
2541686|NCT03020745|Primary|Part 2: Change From Baseline in SBP and DBP at Indicated Time Points|SBP and DBP were measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 113, 141 and 169|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||mmHg||Standard Deviation|Mean
2541687|NCT03020745|Primary|Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points|SBP and DBP were measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the last assessment before the first dose of the study treatment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Day 1: 1 hour, Day 1: 2 hours, Day 1: 4 hours, Day 1: 8 hours, Day 3, Day 8 and Day 30|Safety Population comprised of all participants who received at least one dose of the study treatment (including placebo). Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2541688|NCT03020719|Secondary|Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)|Rate is defined as the number of events per participant follow-up month.|Baseline to 24 weeks||||number of events/total follow-up months|||Number
2541689|NCT03020719|Secondary|Adverse Events (AEs) and Serious Adverse Events (SAEs)|The number and percentage of participants with at least one event over the 24 week follow-up period.|Baseline to 24 weeks||||Participants|||Count of Participants
2541690|NCT03020719|Secondary|Change in High-sensitivity C-reactive Protein (Hs-CRP)|Difference between the oral glutathione and placebo groups in the 24-week change from baseline in hs-CRP.|Baseline to 24 weeks||||mg/L||Standard Deviation|Mean
2541691|NCT03020719|Secondary|Change in Fecal Calprotectin|Difference between the oral glutathione and placebo groups in the 24-week change from baseline in fecal calprotectin.|Baseline to 24 weeks|Include participants with fecal calprotectin measurements at Baseline and Week 24.|||log base 10 transformation of ug/g||Standard Deviation|Mean
2541692|NCT03020719|Secondary|Change in BMI-for-age Z-score|Difference between the oral glutathione and placebo groups in the 24-week change from baseline in BMI-for-age Z-score. BMI-for-age Z-scores are derived from the 2000 Centers for Disease Control and Prevention growth charts for U.S. children. The reference population in these growth charts is children surveyed by the National Center for Health Statistics from 1963-65 to 1988-94. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.|Baseline to 24 weeks||||Z-score||Standard Deviation|Mean
2541693|NCT03020719|Secondary|Change in Height-for-age Z-score|Difference between the oral glutathione and placebo groups in the 24-week change from baseline in height-for-age Z-score. Height-for-age Z-scores are derived from the 2000 Centers for Disease Control and Prevention growth charts for U.S. children. The reference population in these growth charts is children surveyed by the National Center for Health Statistics from 1963-65 to 1988-94. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.|Baseline to 24 weeks||||Z-score||Standard Deviation|Mean
2541694|NCT03020719|Primary|Change in Weight-for-age Z-score|Difference between the oral glutathione and placebo groups in the 24-week change from baseline in weight-for-age Z-score. Weight-for-age Z-scores are derived from the 2000 Centers for Disease Control and Prevention growth charts for U.S. children. The reference population in these growth charts is children surveyed by the National Center for Health Statistics from 1963-65 to 1988-94. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.|Baseline to 24 weeks|Include participants with weight-for-age Z-score measurements at Baseline, Week 12 and Week 24|||Z-score||95% Confidence Interval|Mean
2541695|NCT03020576|Secondary|Change in Motor Activity Log How Well|quantitative, self report scale measuring the 'Amount' and 'How Well' an individual performs a battery of motor tasks. Maximum score of 150 (raw score) for each 'Amount' and 'How Well' sections. Higher scores reflect better performance.|Through study completion (taken at baseline and on 8 week study completion)||||units on a scale||Standard Deviation|Mean
2541696|NCT03020576|Secondary|Change in Spasticity Measures|The Modified Ashworth Scale is a standardized quantitative assessment of muscle tightness/spasticity during movements of the arm and wrist. It is scored on a scale of 1-5, with higher numbers reflecting a greater severity of spasticity.|Through study completion, an average of 8 weeks||||change in units on a scale||Standard Deviation|Mean
2541697|NCT03020576|Secondary|Change in Hand Dexterity|The 9 Hole Peg Test was used as a quantitative measure of hand dexterity. The participant is asked to remove the pegs and put them back into the slots in a period of 100 sec. The number of pegs moved is recorded as an overall score.|Through study completion, an average of 8 weeks||||units on a scale||Standard Deviation|Mean
2541702|NCT03020576|Primary|Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer|quantitative performance measure (scale ranging from 0 (minimum) to 66 (maximum) points) of arm and hand impairment. A higher score represents more skilled movements of the arm and hand.|Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)||||change in units on a scale||Standard Deviation|Mean
2541703|NCT03020537|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization||||Participants|||Count of Participants
2541704|NCT03020537|Primary|Number of Participants Who Received Influenza Vaccine||Day 0 to 28||||Participants|||Count of Participants
2541705|NCT03020498|Other Pre-specified|Investigate the Effects of Different Influenza Vaccines, Including Live Attenuated Vaccine (LAIV) and Inactivated Vaccine Delivered by Different Routes (Intranasal and IM), on B-cell Responses.||Day 0 to 28|||||||
2541706|NCT03020498|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization||||Participants|||Count of Participants
2541707|NCT03020498|Primary|Number of Participants Who Received Influenza Vaccine||Day 0 to 28||||Participants|||Count of Participants
2541708|NCT03020472|Other Pre-specified|PBMC Samples Will be Tested by Flow Cytometry to Determine the Percentage of Influenza-specific Antibody Cells That Are CD27+CD38+CD19+ Plasmablasts and by ELISPOT.||Day 0 to Day 28|||||||
2541709|NCT03020472|Other Pre-specified|Post- Immunization B- Cell Response|Identify peak of the post-immunization B-cell responses following vaccination with live, attenuated influenza vaccine (LAIV)|5-13 days post immunization|Due to the low enrollment, the study was terminated and analysis was not performed.||||||
2541710|NCT03020472|Secondary|Number of Participants With Related Adverse Events||Day 0 to Day 28||||Participants|||Count of Participants
2541711|NCT03020472|Primary|Number of Participants Who Received Influenza Vaccine||Day 0 to Day 28||||Participants|||Count of Participants
2541712|NCT03020160|Secondary|Number of Participants With De Novo Development of Anti-Factor VIII (FVIII) Antibodies|The levels of anti-FVIII antibodies (inhibitors) were analyzed using a validated FVIII activity assay. A participant was considered to have developed de novo FVIII inhibitors if the inhibitor levels detected in a post-baseline sample reached or exceeded a pre-determined threshold. At the clinical cut-off date for primary analysis (15 Dec 2017), the median observation time was 43.71 weeks (range: 41.7-45.7 weeks).|Baseline, Weeks 9 and 17 (for non-inhibitor subjects only), Week 25, and every 12 weeks thereafter until study completion (up to approximately 4 years)|The analysis included all participants who received at least one dose of emicizumab.|||Participants|||Count of Participants
2541713|NCT03020160|Secondary|Number of Participants With Anti-Drug Antibodies to Emicizumab|A validated ELISA method was used to analyze the levels of anti-drug antibodies to emicizumab in blood plasma samples. A sample was considered positive for anti-drug antibodies if the test result reached or exceeded a pre-determined threshold. At the clinical cut-off date for primary analysis (15 Dec 2017), the median observation time was 43.71 weeks (range: 41.7-45.7 weeks).|Baseline, Weeks 5, 9, 13, 17, 21, and 25, and every 12 weeks thereafter until study completion (up to approximately 4 years)|The analysis included all participants who received at least one dose of emicizumab. The number analyzed indicates those with both baseline and post-baseline assessments.|||Participants|||Count of Participants
2541714|NCT03020160|Secondary|Number of Participants With Systemic Hypersensitivity, Anaphylaxis, or Anaphylactoid Reactions|At the clinical cut-off date for primary analysis (15 Dec 2017), the median observation time was 43.71 weeks (range: 41.7-45.7 weeks).|From Baseline to study completion (up to approximately 4 years)|The analysis included all participants who received at least one dose of emicizumab.|||Participants|||Count of Participants
2541715|NCT03020160|Secondary|Number of Participants With Thrombotic Microangiopathy|At the clinical cut-off date for primary analysis (15 Dec 2017), the median observation time was 43.71 weeks (range: 41.7-45.7 weeks).|From Baseline to study completion (up to approximately 4 years)|The analysis included all participants who received at least one dose of emicizumab.|||Participants|||Count of Participants
2541716|NCT03020160|Secondary|Number of Participants With Thromboembolic Events|At the clinical cut-off date for primary analysis (15 Dec 2017), the median observation time was 43.71 weeks (range: 41.7-45.7 weeks).|From Baseline to study completion (up to approximately 4 years)|The analysis included all participants who received at least one dose of emicizumab.|||Participants|||Count of Participants
2541717|NCT03020160|Secondary|Number of Participants With Local Injection-Site Reactions|"Local adverse events that occurred within 24 hours after study drug administration and, in the investigator's opinion, were judged to be related to study drug injection, were captured as an injection-site reaction on the Adverse Event electronic Case Report Form (eCRF). An injection-related reaction that was localized was marked as a local injection-site reaction. At the clinical cut-off date for primary analysis (15 Dec 2017), the median observation time was 43.71 weeks (range: 41.7-45.7 weeks)."|From Baseline to study completion (up to approximately 4 years)|The analysis included all participants who received at least one dose of emicizumab.|||Participants|||Count of Participants
2541718|NCT03020160|Secondary|Number of Participants With Adverse Events of Abnormal Laboratory Values|"The number of participants with adverse events of abnormal laboratory values is reported here. An abnormal laboratory value is defined as a laboratory test result outside of the normal range for hematology or serum chemistries.~It is reported as an adverse event if it meets any of the following criteria: is accompanied by clinical symptoms; results in a change in study treatment (e.g., dosage modification, treatment interruption or discontinuation); results in a medical intervention or a change in concomitant therapy; or is clinically significant in the investigator's judgment. At the clinical cut-off date for primary analysis (15 Dec 2017), the median observation time was 43.71 weeks (range: 41.7-45.7 weeks)."|From Baseline to study completion (up to approximately 4 years)|The analysis included all participants who received at least one dose of emicizumab.|||Participants|||Count of Participants
2541719|NCT03020160|Secondary|Number of Participants With Adverse Events of Changes From Baseline in Physical Examination Findings|Post-baseline physical examination abnormalities that were not present at baseline or worsened were reported as adverse events. At the clinical cut-off date for primary analysis (15 Dec 2017), the median observation time was 43.71 weeks (range: 41.7-45.7 weeks).|From Baseline to study completion (up to approximately 4 years)|The analysis included all participants who received at least one dose of emicizumab.|||Participants|||Count of Participants
2541720|NCT03020160|Secondary|Number of Participants With Adverse Events of Changes From Baseline in Vital Signs|The number of participants with adverse events of changes from baseline in vital signs is reported here. Vital signs measurements consisted of heart and respiratory rate, temperature, and systolic and diastolic blood pressures, with an abnormal vital sign value being outside of the normal range. An abnormal vital sign result is reported as an adverse event if it meets any of the following criteria: is accompanied by clinical symptoms; results in a change in study treatment (e.g., dosage modification, treatment interruption or discontinuation); results in a medical intervention or a change in concomitant therapy; or is clinically significant in the investigator's judgment. At the clinical cut-off date for primary analysis (15 Dec 2017), the median observation time was 43.71 weeks (range: 41.7-45.7 weeks).|From Baseline to study completion (up to approximately 4 years)|The analysis included all participants who received at least one dose of emicizumab.|||Participants|||Count of Participants
2541721|NCT03020160|Secondary|Number of Participants With Adverse Events Leading to Withdrawal From Treatment|At the clinical cut-off date for primary analysis (15 Dec 2017), the median observation time was 43.71 weeks (range: 41.7-45.7 weeks).|From Baseline to study completion (up to approximately 4 years)|The analysis included all participants who received at least one dose of emicizumab.|||Participants|||Count of Participants
2541722|NCT03020160|Secondary|Number of Participants With Grade ≥3 Adverse Events|The World Health Organization (WHO) toxicity grading scale will be used for assessing adverse event severity. For adverse events that are not specifically listed in the WHO toxicity grading scale, a grade 3 adverse event is defined as: severe, marked limitation in activity, some assistance usually required, medical intervention or therapy required, hospitalization possible; and a grade 4 adverse event is defined as: life-threatening, extreme limitation in activity, significant assistance required, significant medical intervention or therapy required, hospitalization or hospice care probable. At the clinical cut-off date for primary analysis (15 Dec 2017), the median observation time was 43.71 weeks (range: 41.7-45.7 weeks).|From Baseline to study completion (up to approximately 4 years)|The analysis included all participants who received at least one dose of emicizumab.|||Participants|||Count of Participants
2541723|NCT03020160|Secondary|Number of Participants With At Least One Adverse Event|The number of participants experiencing at least one adverse event, including all non-serious and serious adverse events, is reported here. At the clinical cut-off date for primary analysis (15 Dec 2017), the median observation time was 43.71 weeks (range: 41.7-45.7 weeks).|From Baseline to study completion (up to approximately 4 years)|The analysis included all participants who received at least one dose of emicizumab.|||Participants|||Count of Participants
2541724|NCT03020160|Secondary|Expansion Part: Minimum Observed Plasma Concentration (Cmin) of Emicizumab||Predose at Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21, 25, and once every 12 weeks from Week 25 to study completion (up to approximately 4 years)|The analysis included all participants enrolled in the expansion part of the study. The number analyzed represents the number of participants with an evaluable sample at a given time point.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2541725|NCT03020160|Secondary|PK Run-In Part: Apparent Clearance (CL/F) of Emicizumab|Only CL/F is reported after the first dose; the apparent clearance at steady state (CLss/F) is reported after the sixth dose instead. This is because t1/2 was not properly estimated after the first dose due to sampling time and dosing schedule, and dependent PK parameters, such as CL/F, could not be estimated.|Predose (0 hr) and 8 hrs postdose on Day 1; Days 3,5,8,11,15,18,22,25,29,36,43,50,57,85,113,141,148,155,162,169, once between 2 emicizumab administrations between Weeks 9 and 21, and once every 12 weeks from Week 25 to study completion (up to 4 years)|The analysis included all participants enrolled in the PK Run-In part of the study.|||mL/h||Geometric Coefficient of Variation|Geometric Mean
2541726|NCT03020160|Secondary|PK Run-In Part: Apparent Plasma Terminal Half-Life (t1/2) of Emicizumab||Predose (0 hr) and 8 hrs postdose on Day 1; Days 3,5,8,11,15,18,22,25,29,36,43,50,57,85,113,141,148,155,162,169, once between 2 emicizumab administrations between Weeks 9 and 21, and once every 12 weeks from Week 25 to study completion (up to 4 years)|The analysis included all participants enrolled in the PK Run-In part of the study. t1/2 was not properly estimated after the first dose due to sampling time and dosing schedule; hence, t1/2 could not be determined after the sixth dose of emicizumab.|||day||Geometric Coefficient of Variation|Geometric Mean
2541727|NCT03020160|Secondary|PK Run-In Part: Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC[0-inf]) of Emicizumab||Predose (0 hr) and 8 hrs postdose on Day 1; Days 3,5,8,11,15,18,22,25,29,36,43,50,57,85,113,141,148,155,162,169, once between 2 emicizumab administrations between Weeks 9 and 21, and once every 12 weeks from Week 25 to study completion (up to 4 years)|The analysis included all participants enrolled in the PK Run-In part of the study. t1/2 was not properly estimated after the first dose due to sampling time and dosing schedule; hence, dependent PK parameters, such as AUC[0-inf], could not be estimated after the sixth dose of emicizumab.|||day*μg/mL||Geometric Coefficient of Variation|Geometric Mean
2541728|NCT03020160|Secondary|PK Run-In Part: Area Under the Plasma Concentration-Time Curve From Time Zero to End of Dosing Interval (AUC[0-tau]) of Emicizumab||Predose (0 hr) and 8 hrs postdose on Day 1; Days 3,5,8,11,15,18,22,25,29,36,43,50,57,85,113,141,148,155,162,169, once between 2 emicizumab administrations between Weeks 9 and 21, and once every 12 weeks from Week 25 to study completion (up to 4 years)|The analysis included all participants enrolled in the PK Run-In part of the study.|||day*μg/mL||Geometric Coefficient of Variation|Geometric Mean
2541729|NCT03020160|Secondary|PK Run-In Part: Maximum Observed Plasma Concentration (Cmax) of Emicizumab||Predose (0 hr) and 8 hrs postdose on Day 1; Days 3,5,8,11,15,18,22,25,29,36,43,50,57,85,113,141,148,155,162,169, once between 2 emicizumab administrations between Weeks 9 and 21, and once every 12 weeks from Week 25 to study completion (up to 4 years)|The analysis included all participants enrolled in the PK Run-In part of the study.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2541730|NCT03020160|Secondary|PK Run-In Part: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Emicizumab||Predose (0 hr) and 8 hrs postdose on Day 1; Days 3,5,8,11,15,18,22,25,29,36,43,50,57,85,113,141,148,155,162,169, once between 2 emicizumab administrations between Weeks 9 and 21, and once every 12 weeks from Week 25 to study completion (up to 4 years)|The analysis included all participants enrolled in the PK Run-In part of the study.|||day||Full Range|Median
2541964|NCT03014700|Secondary|Length of Stay in Intensive Care Unit (ICU)||From administration of the drug during surgery to discharge from the ICU (up to 3 months)|Participants who completed the protocol are included in the analysis|||days||Inter-Quartile Range|Median
2541731|NCT03020160|Secondary|Expansion Part: Percentage of Participants Who Preferred Either the New Emicizumab Subcutaneous (SC) Treatment or Their Previous Hemophilia Intravenous (IV) Treatment, or Had No Preference, as Assessed Using the Emicizumab Preference Survey|The Emicizumab Preference Survey is a fit-for-purpose questionnaire developed by the sponsor to record the participant's preference for treatment with intravenous (IV) factor VIIII (FVIII) or subcutaneous (SC) emicizumab, or no preference.|Predose at Week 17|The analysis included all participants enrolled in the expansion part of the study.|||percentage of participants||95% Confidence Interval|Number
2541732|NCT03020160|Secondary|Expansion Part: Number of Days Hospitalized|At the clinical cut-off date for primary analysis (15 Dec 2017), the median observation time was 43.71 weeks (range: 41.7-45.7 weeks); all participants had completed at least 24 weeks of treatment.|From Baseline until at least 24 weeks of treatment through to study completion (up to approximately 4 years)|The analysis included all participants enrolled in the expansion part of the study.|||days||Standard Deviation|Mean
2541733|NCT03020160|Secondary|Expansion Part: Proportion of Days Away From School to Expected Days at School in the Previous Four Weeks|Participants enrolled in the expansion part of the study reported at each time point the number of days away from school (i.e., days of school missed) and the expected number of days at school in the previous four weeks, which is reported here as the proportion of the number of days away from school to the expected number of days at school.|Predose at Baseline, Weeks 13 and 25, and every 12 weeks thereafter up to study completion/early termination (up to approximately 4 years)|The analysis included all participants enrolled in the expansion part of the study. The number analyzed represents participants who were enrolled in school and completed the questionnaire at Baseline, Week 13, and Week 25.|||away/expected school days||95% Confidence Interval|Mean
2541734|NCT03020160|Secondary|Expansion Part: Proportion of Days Away From Work to Expected Days at Work in the Previous Four Weeks|Participants enrolled in the expansion part of the study reported at each time point the number of days away from work (i.e., days of work missed) and the expected number of days at work in the previous four weeks, which is reported here for each time point as the proportion of the number of days away from work to the expected number of days at work.|Predose at Baseline, Weeks 13 and 25, and every 12 weeks thereafter up to study completion/early termination (up to approximately 4 years)|The analysis included all participants enrolled in the expansion part of the study. The number analyzed represents participants who were working and completed the questionnaire at Baseline, Week 13, and Week 25.|||away/expected work days||95% Confidence Interval|Mean
2541735|NCT03020160|Secondary|Expansion Part: Percentage of Participants With a Meaningful Improvement From Baseline to Week 25 in the EQ-5D-5L Questionnaire Index Utility Score|The EQ-5D-5L is a self-reported health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. Published weighting systems allow for creation of a single summary score for the Index Utility Score where overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction. An increase in the Index Utility Score of 0.07 points or greater was defined as the threshold for a meaningful improvement.|Baseline, Week 25|The analysis included all participants enrolled in the expansion part of the study. The number analyzed represents participants who completed the questionnaire at Baseline and Week 25.|||percentage of participants|||Number
2541736|NCT03020160|Secondary|Expansion Part: Change From Baseline to Week 25 in the EQ-5D-5L Questionnaire Index Utility Score|The EQ-5D-5L is a self-reported health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. Published weighting systems allow for creation of a single summary score for the Index Utility Score where overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction. An increase in the Index Utility Score of 0.07 points or greater was defined as the threshold for a meaningful improvement.|Baseline, Week 25|The analysis included all participants enrolled in the expansion part of the study. The number analyzed represents participants who completed the questionnaire at Baseline and Week 25.|||units on a scale||95% Confidence Interval|Mean
2541737|NCT03020160|Secondary|Expansion Part: Percentage of Participants With a Meaningful Improvement From Baseline to Week 25 in the EQ-5D-5L Questionnaire VAS Score|The EQ-5D-5L is a self-reported health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. An increase in the VAS score of 7 points or greater was defined as the threshold for a meaningful improvement.|Baseline, Week 25|The analysis included all participants enrolled in the expansion part of the study. The number analyzed represents participants who completed the questionnaire at Baseline and Week 25.|||percentage of participants|||Number
2541738|NCT03020160|Secondary|Expansion Part: Change From Baseline to Week 25 in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire Visual Analogue Scale (VAS) Score|The EQ-5D-5L is a self-reported health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. An increase in the VAS score of 7 points or greater was defined as the threshold for a meaningful improvement.|Baseline, Week 25|The analysis included all participants enrolled in the expansion part of the study. The number analyzed represents participants who completed the questionnaire at Baseline and Week 25.|||units on a scale||95% Confidence Interval|Mean
2541739|NCT03020160|Secondary|Expansion Part: Change From Baseline to Week 25 in the Hemophilia-Quality of Life-Short Form (Haemo-QoL-SF) Questionnaire Total Score for Adolescent Participants (12-17 Years of Age)|The Haemo-QoL-SF was developed in a series of age-related questionnaires to measure health-related quality of life (HRQoL) in children and adolescents with hemophilia. The short version for older children containing 35 items was selected for adolescents in this study. Items are rated along five response options: never, rarely, sometimes, often, or all the time. This version covers nine dimensions considered relevant for the children's HRQoL (physical health, feelings, view of yourself, family, friends, other people, sports and school, dealing with hemophilia, and treatment). Scale scores range from 0 to 100, with lower scores indicating better HRQoL. Given the small number of adolescent participants, the results of the Haemo-QoL-SF questionnaire should be interpreted with caution.|Baseline, Week 25|The analysis included all adolescent participants enrolled in the expansion part of the study. The number analyzed represents participants who completed the questionnaire at Baseline and Week 25.|||units on a scale||Standard Deviation|Mean
2541740|NCT03020160|Secondary|Expansion Part: Percentage of Adult Participants (≥18 Years of Age) With a Clinically Meaningful Improvement From Baseline to Week 25 in the Haem-A-QoL Questionnaire Physical Health Score|"The Haem-A-QoL is a patient-reported questionnaire that was designed for adult participants with hemophilia. It consists of 46 items comprising 10 dimensions (physical health, sports and leisure, school and work, dealing with hemophilia, family planning, feelings, relationships, treatment, view of yourself, and outlook for the future) and a scale representing Total Score. Items are rated along five response options: never, rarely, sometimes, often, or all the time; although for some items there is also a not applicable option. Scale scores range from 0 to 100 with lower scores reflective of better quality of life. A decrease of 10 points or more on the Physical Health Score was defined as the threshold for a clinically meaningful improvement."|Baseline, Week 25|The analysis included all adult participants enrolled in the expansion part of the study. The number analyzed represents participants who completed the questionnaire at Baseline and Week 25.|||percentage of participants|||Number
2541741|NCT03020160|Secondary|Expansion Part: Change From Baseline to Week 25 in the Haem-A-QoL Questionnaire Physical Health Score for Adult Participants (≥18 Years of Age)|"The Haem-A-QoL is a patient-reported questionnaire that was designed for adult participants with hemophilia. It consists of 46 items comprising 10 dimensions (physical health, sports and leisure, school and work, dealing with hemophilia, family planning, feelings, relationships, treatment, view of yourself, and outlook for the future) and a scale representing Total Score. Items are rated along five response options: never, rarely, sometimes, often, or all the time; although for some items there is also a not applicable option. Scale scores range from 0 to 100 with lower scores reflective of better quality of life. A decrease of 10 points or more on the Physical Health Score was defined as the threshold for a clinically meaningful improvement."|Baseline, Week 25|The analysis included all adult participants enrolled in the expansion part of the study. The number analyzed represents participants who completed the questionnaire at Baseline and Week 25.|||units on a scale||95% Confidence Interval|Mean
2541742|NCT03020160|Secondary|Expansion Part: Percentage of Adult Participants (≥18 Years of Age) With a Clinically Meaningful Improvement From Baseline to Week 25 in the Haem-A-QoL Questionnaire Total Score|"The Haem-A-QoL is a patient-reported questionnaire that was designed for adult participants with hemophilia. It consists of 46 items comprising 10 dimensions (physical health, sports and leisure, school and work, dealing with hemophilia, family planning, feelings, relationships, treatment, view of yourself, and outlook for the future) and a scale representing Total Score. Items are rated along five response options: never, rarely, sometimes, often, or all the time; although for some items there is also a not applicable option. Scale scores range from 0 to 100 with lower scores reflective of better quality of life. A decrease of 7 points or more on the Total Score was defined as the threshold for a clinically meaningful improvement."|Baseline, Week 25|The analysis included all adult participants enrolled in the expansion part of the study. The number analyzed represents participants who completed the questionnaire at Baseline and Week 25.|||percentage of participants|||Number
2541743|NCT03020160|Secondary|Expansion Part: Change From Baseline to Week 25 in the Hemophilia A Quality of Life (Haem-A-QoL) Questionnaire Total Score for Adult Participants (≥18 Years of Age)|"The Haem-A-QoL is a patient-reported questionnaire that was designed for adult participants with hemophilia. It consists of 46 items comprising 10 dimensions (physical health, sports and leisure, school and work, dealing with hemophilia, family planning, feelings, relationships, treatment, view of yourself, and outlook for the future) and a scale representing Total Score. Items are rated along five response options: never, rarely, sometimes, often, or all the time; although for some items there is also a not applicable option. Scale scores range from 0 to 100 with lower scores reflective of better quality of life. A decrease of 7 points or more on the Total Score was defined as the threshold for a clinically meaningful improvement."|Baseline, Week 25|The analysis included all adult participants enrolled in the expansion part of the study. The number analyzed represents participants who completed the questionnaire at Baseline and Week 25.|||units on a scale||95% Confidence Interval|Mean
2541744|NCT03020160|Primary|Expansion Part: Annualized Bleeding Rate (ABR) for Treated Target Joint Bleeds|"The number of treated target joint bleeds over the efficacy period is presented as an annualized bleeding rate (ABR) that was analyzed using a negative binomial regression model with efficacy period as an offset to account for the difference in follow-up times (i.e., the time that each participant stays in the study). A target joint bleed is defined as a joint bleed in a target joint, which is a joint location where at least 3 bleeds have occurred over the last 24 weeks prior to study entry. A treated target joint bleed is a target joint bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Bleeds due to surgery/procedure are excluded."|From Baseline to at least 24 weeks|The analysis included all participants enrolled in the expansion part of the study.|||treated target joint bleed rate per year||95% Confidence Interval|Number
2541756|NCT03019744|Secondary|Change Score of VAS for Perceived Pain Between Two Time Points: Post-treatment vs Pre-treatment|VAS: Visual Analogic Scale for perceived pain on a 10-level scale. VAS minimum value is 0 and maximum value is 10. Higher scores mean worse outcome (more severe pain).|5 weeks (post-treatment vs pre-treatment)||||score on a scale||Inter-Quartile Range|Median
2541965|NCT03014700|Secondary|Hours of Mechanical Ventilation||From administration of the drug during surgery to extubation in the ICU (up to 30 days)|Participants who completed the protocol are included in the analysis|||hours||Inter-Quartile Range|Median
2541745|NCT03020160|Primary|Expansion Part: Annualized Bleeding Rate (ABR) for Treated Joint Bleeds|"The number of treated joint bleeds over the efficacy period is presented as an annualized bleeding rate (ABR) that was analyzed using a negative binomial regression model with efficacy period as an offset to account for the difference in follow-up times (i.e., the time that each participant stays in the study). A joint bleed is defined as a bleed with type reported as joint and with at least one of the following symptoms: increasing swelling or warmth of the skin over the joint and/or increasing pain, decreased range of motion, or difficulty using the joint compared with baseline. A treated joint bleed is a joint bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Treated bleeds that fulfilled the 72-hour rule were included in the analysis of joint bleeds, excluding bleeds due to surgery/procedure."|From Baseline to at least 24 weeks|The analysis included all participants enrolled in the expansion part of the study.|||treated joint bleed rate per year||95% Confidence Interval|Number
2541746|NCT03020160|Primary|Expansion Part: Annualized Bleeding Rate (ABR) for Treated Spontaneous Bleeds|"The number of treated spontaneous bleeds over the efficacy period is presented as an annualized bleeding rate (ABR) that was analyzed using a negative binomial regression model with efficacy period as an offset to account for the difference in follow-up times (i.e., the time that each participant stays in the study). A bleed is classified as spontaneous if there is no other known contributing factor such as trauma or procedure/surgery. A treated spontaneous bleed is a spontaneous bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Treated bleeds that fulfilled the 72-hour rule were included in the analysis of spontaneous bleeds. Bleeds due to surgery/procedure are excluded."|From Baseline to at least 24 weeks|The analysis included all participants enrolled in the expansion part of the study.|||treated spontaneous bleed rate per year||95% Confidence Interval|Number
2541747|NCT03020160|Primary|Expansion Part: Annualized Bleeding Rate (ABR) for All Bleeds|"The number of all bleeds over the efficacy period is presented as an annualized bleeding rate (ABR) that was analyzed using a negative binomial regression model with efficacy period as an offset to account for the difference in follow-up times (i.e., the time that each participant stays in the study). In this outcome measure, all bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded. As all bleeds comprises both treated and non-treated bleeds, the 72-hour rule was implemented separately for treated and non-treated bleeds. For treated bleeds, the 72-hour rule was implemented exactly as defined for the treated bleeds outcome measure. For non-treated bleeds, the 72-hour rule was implemented by calculating a treatment-free period of 72 hours from the bleed itself."|From Baseline to at least 24 weeks|The analysis included all participants enrolled in the expansion part of the study.|||all bleed rate per year||95% Confidence Interval|Number
2541748|NCT03020160|Primary|Expansion Part: Annualized Bleeding Rate (ABR) for Treated Bleeds|"The number of treated bleeds over the efficacy period is presented as an annualized bleeding rate (ABR) that was analyzed using a negative binomial regression model with efficacy period as an offset to account for the difference in follow-up times. A bleed is considered a treated bleed if it is directly followed (i.e., no intervening bleed) by a hemophilia medication reported to be a treatment for bleed, irrespective of time between treatment and the preceding bleed. A bleed and the first treatment thereafter and before a new bleed starts, are considered to be pairs, with the following exception: if multiple bleeds occur on the same calendar day, the subsequent treatment is considered to apply for each of these multiple bleeds. The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location are counted as one bleed if the second bleed occurs within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure are excluded."|From Baseline to at least 24 weeks|The analysis included all participants enrolled in the expansion part of the study.|||treated bleed rate per year||95% Confidence Interval|Number
2541749|NCT03020069|Primary|Change in Score of Diabetes Empowerment Scale Short Form (DES-SF) From Baseline to 3 Months|There are 8 items that constitute the DES-SF. The scale is scored by averaging the scores of all completed items. 1 = strongly disagree and 5 = strongly agree. The change in score between baseline and 3 months will be calculated by subtracting the average score from 3 months from the baseline score.|Baseline, 3 months||||units on a scale||Full Range|Mean
2541750|NCT03020069|Primary|Change in Level of Blood Sugar (Glucose) From Baseline to 3 Months|Blood sugar (glucose) will be measured via glucose monitors. The change in level of blood sugar will be calculated by subtracting the blood glucose level at 3 months from the blood glucose level at baseline.|Baseline, 3 Months||||mg/dl||Full Range|Mean
2541751|NCT03020069|Primary|Change in Glycated Hemoglobin (HbA1c) Levels From Baseline to 3 Months|HbA1c measurements will be measured in the lab at the location of the patient's visit at baseline and 3 months. The measured HbA1c level at 3 months will be subtracted from the measured level at baseline to calculate the change.|Baseline, 3 Months||||mmol/mol||Full Range|Mean
2541752|NCT03020069|Primary|Change in Score of Pediatric Quality of Life Inventory 3.2 Diabetes Module (Peds QL 3.2) From Baseline to 3 Months|The PedsQL 3.2 Diabetes Module is composed of 33 items. Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The total score is calculated as the sum of all items over the number of items answered on all the scales (total score ranges from 0-3300). Higher scores indicate lower problems. The change in total score is calculated by subtracting the total score at baseline from the total score at 3 months.|Baseline, 3 Months||||score on a scale||Full Range|Mean
2541753|NCT03020004|Primary|Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment|SVR12, defined as undetectable HCV RNA 12 weeks after the last day of study drug administration|24 weeks||||Participants|||Count of Participants
2541754|NCT03019783|Secondary|Change in Plasma Total Antioxidant Capacity|The investigators will evaluate plasma total antioxidant capacity at study entry and then after 28 days, with the change between the two measurements being the secondary endpoint.|4 weeks||||micromolar||Standard Deviation|Mean
2541755|NCT03019783|Primary|Change in Flow-mediated, Endothelium-dependent Vasodilation|The investigators will evaluate flow-mediated, brachial artery vasodilation (percentage increase in diameter in response to a 5 minute ischemic challenge) at study entry and then after 28 days, with the change between the two measurements being the primary endpoint.|4 weeks||||percentage vasodilation||Standard Deviation|Mean
2541757|NCT03019744|Secondary|Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment|DASH: Quick version of the Disability of the Arm Shoulder and Hand questionnaire (see in References section: Kennedy et al. 2011) DASH minimum value is 0 and maximum value is 100. Higher scores mean worse outcome.|5 weeks (post-treatment vs pre-treatment)|2 patients (both belonging to Control group) did not attend the post-treatment DASH evaluation, thus they were excluded from this analysis.|||score on a scale||Standard Deviation|Mean
2541758|NCT03019744|Secondary|Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment|"IPPA: Individually Prioritized Problem Assessment (see in References section: Wessels R et al. 2000).~IPPA minimum value is 1 and maximum value is 25. Higher scores mean worse outcome."|5 weeks (post-treatment vs pre-treatment)|3 patients (1 belonging to MeCFES group and 2 to Control group) did not attend the post-treatment IPPA evaluation, thus they were excluded from this analysis.|||score on a scale||Standard Deviation|Mean
2541759|NCT03019744|Primary|Change Score of FMA-UE Scale Between Two Time Points: Post-treatment vs Pre-treatment|"FMA-UE: Upper Extremities section of Fugl Meyer Assessment scale (see in References section: Fugl-Meyer AR et al 1975).~FMA-UE minimum value is 0 and maximum value is 66. Higher scores mean a better outcome"|5 weeks (post-treatment vs pre-treatment)||||score on a scale||Standard Deviation|Mean
2541760|NCT03019744|Primary|Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment|"ARAT: Action Research Arm Test scale (15 item) (see in References section: Van der Lee JH et al 2002).~ARAT minimum value is 0 and maximum value is 45. Higher scores mean a better outcome."|5 weeks (post-treatment vs pre-treatment)||||score on a scale||Standard Deviation|Mean
2541761|NCT03019627|Secondary|Change From Baseline in Wetting Distance|The Schirmer test without anesthesia was performed to measure aqueous tear secretion prior to the instillation of any dilating or eye drops|week 8|Full analysis set population|||millimeters||Standard Deviation|Mean
2541762|NCT03019627|Secondary|Change in Tear Film Break-up Time (TFBUT)|TFBUT was measured by determining the time to tear break-up. The TFBUT was performed after instillation of 5 μL of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. The patient was instructed to blink several times to thoroughly mix the fluorescein with the tear film.|week 4, week 8, week 12|Full analysis set population|||seconds||Standard Deviation|Mean
2541763|NCT03019627|Secondary|Conjunctival Vital Staining|"Changes from baseline on National Eye Institute (NEI) scale. The NEI/Industry Workshop guidelines were used for grading the scale of corneal and conjunctival damage. The cornea was divided into five sectors (central, superior, inferior, nasal and temporal), each of which was scored on a scale of 0-3, with a maximal total corneal staining score of 15.~Both nasally and temporally, the conjunctiva was divided into a superior paralimbal area, an inferior paralimbal area, and a peripheral area with a grading scale of 0-3 and with a maximal total score of 9 for the nasal and temporal conjunctiva (overall the total score ranged from 0-18).~Briefly, grade 0 reflected normal/healthy situation, whereas grade 3 reflected a severe damage in the considered sector."|week 4, week 8, week 12|Full analysis set population|||units on a scale||Standard Deviation|Mean
2541764|NCT03019627|Secondary|Cornea Vital Staining|"Changes from baseline on National Eye Institute (NEI) scale. The NEI/Industry Workshop guidelines were used for grading the scale of corneal and conjunctival damage. The cornea was divided into five sectors (central, superior, inferior, nasal and temporal), each of which was scored on a scale of 0-3, with a maximal total corneal staining score of 15.~Both nasally and temporally, the conjunctiva was divided into a superior paralimbal area, an inferior paralimbal area, and a peripheral area with a grading scale of 0-3 and with a maximal total score of 9 for the nasal and temporal conjunctiva (overall the total score ranged from 0-18).~Briefly, grade 0 reflected normal/healthy situation, whereas grade 3 reflected a severe damage in the considered sector."|week 4, week 8, week 12|Full analysis set population|||units on a scale||Standard Deviation|Mean
2541765|NCT03019627|Secondary|SANDE Scores|"Change from baseline with Last Observation Carried Forward (LOCF) imputation. LOCF is a method of imputing missing data in longitudinal studies and tests for difference in mean rates of change in controlled repeated measurements designs with dropouts.~The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms."|Week 4, week 8, week 12|Full analysis set population|||units on a scale||Standard Deviation|Mean
2541766|NCT03019627|Primary|Symptom Assessment in Dry Eye (SANDE) Scores|"Change from baseline with Last Observation Carried Forward (LOCF) imputation. LOCF is a method of imputing missing data in longitudinal studies and tests for difference in mean rates of change in controlled repeated measurements designs with dropouts.~The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms."|week 8|Full analysis set population|||units on a scale||Standard Deviation|Mean
2541767|NCT03019549|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lanabecestat|.Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose|All participants who received at least 1 dose of study drug and had evaluable PK data. Period 2 stand alone lanabecestat PK was not performed so only 2 arms are presented that is the data in totality.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2541768|NCT03019549|Secondary|Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814)|Pharmacokinetics (PK): Area Under the Drug Concentration Time Curve During a 24-hour Dosing Interval (AUCτ) of Lanabecestat (LY3314814)|Period 2 (Day 7, 8): Predose, 0.5, 1, 2, 3, 4, 8, 12 hours postdose|All participants who received at least 1 dose of study drug, had evaluable PK parameters. Period 2 stand alone lanabecestat PK was not performed so only 2 arms are presented that is the data in totality.|||hours times nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2541780|NCT03018938|Secondary|Change From Baseline to Week 24 in Body Weight|LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.|Baseline, 24 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Body Weight.|||kilograms (kg)||Standard Error|Least Squares Mean
2541769|NCT03019549|Primary|Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve From Zero to Infinity (AUC-∞) of Rosuvastatin|Pharmacokinetics (PK): Area Under The Drug Concentration Time Curve from Zero to Infinity (AUC-∞) of Rosuvastatin|1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose|All participants who received at least 1 dose of study drug, had evaluable PK parameters. Period 2 stand alone lanabecestat PK was not performed so only 2 arms are presented that is the data in totality.|||hours times nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2541770|NCT03019458|Secondary|Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure|It has been reported that the Mid Upper Arm Circumference is a good predictor for BMI. It will serve as an indirect measurement to the subjects' BMI|After baseline measurements, the investigators will measure the MUAC evey month for 3 months|All participants in the trial|||cm||95% Confidence Interval|Mean
2541771|NCT03019458|Secondary|Number of Hospitalizations Secondary to Infectious Causes|number of hospitalizations secondary to infections in both arms at the end of the study|3 months (study close out)|all participants were analyzed|||Participants|||Count of Participants
2541772|NCT03019458|Secondary|All Cause Mortality|number of deaths in both arms at the end of the study|3 months (study close out)|Everyone who enrolled were analyzed|||Participants|||Count of Participants
2541773|NCT03019458|Primary|The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale.|The investigators will first take a baseline Body Mass Index in kg/m^2 for both control and intervention group, then subsequent measures every two weeks for 3 month duration of he trial. The goal of the investigators is to compare the net change in Body Mass Index in a 3 month period.|after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months|We proposed an intention to treat analysis, so regardless of whether an XDP subject took the prescribed # of MINGO packets or not we analyzed everyone who entered the trial|||Kg/m^2||95% Confidence Interval|Mean
2541774|NCT03018938|Secondary|Change From Baseline to Week 48 in Self-Efficacy About Insulin Therapy Questionnaire (SEITQ) Score|The SEITQ is designed to measure an individual's self-efficacy related to insulin therapy. The SEITQ consists of 5 items (that is, statements). The first 4 statements imply confidence in completing the tasks needed to take insulin correctly and avoid both hyperglycemia and hypoglycemia, whereas the last statement is an outcome expectation and implies that performance of these tasks will lead to avoidance of complications. Each item score ranges from 1 (strongly disagree) to 7 (strongly agree). The total SEITQ score is the sum of each item scores, with the range of 5 to 35. Higher SEITQ score indicates better outcome (higher self-efficacy). LS Mean was calculated using Mixed Models Analysis (MMRM) for repeated measures with all post-baseline SEITQ as responses, baseline SEITQ as a continuous covariate, treatment group, Visits, and treatment by visit interaction as fixed effects and participant as a random effect.|Baseline, 48 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for SEITQ Score.|||Units on a scale||Standard Error|Least Squares Mean
2541775|NCT03018938|Secondary|Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 48|Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.|48 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c <7%.|||Percentage of participants|||Number
2541776|NCT03018938|Secondary|Percentage of Participants Who Achieve the HbA1c <7% Without Switching and Discontinuing Study Insulin, and Without Using Rescue Therapy at Week 24|Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Percentages of participants who achieved HbA1c levels of <7% were analyzed using a logistic regression model with logic link function, treatment as fixed effect and baseline HbA1c as continuous covariate.|24 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c <7%.|||Percentage of participants|||Number
2541777|NCT03018938|Secondary|Number of Participants With Insulin Treatment Change at Week 48|"Insulin treatment change can be insulin treatment discontinuation, switch, intensification or reduction in frequency.~Discontinuation: Defined as stopping insulin treatment for 30 days or more.~Switch: Defined as stop the initial insulin therapy and started another insulin therapy of different class.~Intensification: Defined as any of the following: adding meal time insulin in basal insulin analog QD group; changing from BID to TID (Three times a day) in insulin analog mid mixture BID group~Reduction in frequency: Defined as any of the following: changing from BID to QD; changing from TID to BID or QD."|Baseline through 48 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Insulin Treatment Change.|||Participants|||Count of Participants
2541778|NCT03018938|Secondary|Rate of Hypoglycemia at Week 24 and 48|Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). The overall yearly rates (events/participant/year) of those hypoglycemic events, calculated as, for each participant, the number of episodes times 365.25 and then divided by the participants treatment duration, will be summarized, and analyzed by a Negative-binomial regression model with treatment as fixed effects and log of (patient's treatment duration/365.25) as an offset variable.|24 Weeks, 48 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Hypoglycemia.|||Events/Participant/Year||Standard Deviation|Mean
2541779|NCT03018938|Secondary|Change From Baseline to Week 48 in Body Weight|LS means were calculated using ANCOVA model with LOCF and with terms for change from baseline in bodyweight as response, treatment as fixed effect and baseline bodyweight as covariate.|Baseline, 48 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Body Weight.|||kilograms (kg)||Standard Error|Least Squares Mean
2541781|NCT03018938|Secondary|Total Daily Insulin Dose at Week 24 and 48|Total daily insulin dose in the basal insulin analog and in Insulin Analog Mid Mixture group at week 24 and 48.|24 Weeks, 48 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Daily Insulin Dose.|||International Units (IU) per day||Standard Deviation|Mean
2541782|NCT03018938|Secondary|Change From Baseline to Week 48 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose|Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.|Baseline, 48 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for FBG and PPG.|||mmol/L||Standard Error|Least Squares Mean
2541783|NCT03018938|Secondary|Change From Baseline to Week 24 in Finger Stick Blood Glucose (FSBG)-Based Fasting Blood Glucose, Post Prandial Glucose|Fasting blood glucose (FBG) and post prandial glucose (PPG) [pre-breakfast (fasting) and post-breakfast (approximately 2 hours after breakfast)] was measured using FSBG. LS Mean was measured with ANCOVA model with LOCF and with terms for change from baseline in FSBG-based FBG/PPG as response, treatment as fixed effect and baseline FSBG-based FBG/PPG as covariate.|Baseline, 24 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for FBG and PPG.|||mmol/L||Standard Error|Least Squares Mean
2541784|NCT03018938|Secondary|Change From Baseline to Week 48 in Venous Fasting Plasma Glucose|Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.|Baseline, 48 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Venous Fasting Plasma Glucose.|||millimole/liter (mmol/L)||Standard Error|Least Squares Mean
2541785|NCT03018938|Secondary|Change From Baseline to Week 24 in Venous Fasting Plasma Glucose|Fasting Plasma glucose (FPG) is a test to determine how much glucose (sugar) is in a plasma sample after an overnight fast. Least Squares (LS) means was determined by ANCOVA model with LOCF and with terms for change from baseline in Venous FPG as response, treatment as fixed effect and baseline Venous FPG as covariate.|Baseline, 24 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for Venous Fasting Plasma Glucose.|||millimole/liter (mmol/L)||Standard Error|Least Squares Mean
2541786|NCT03018938|Secondary|Percentage of Participants Who Achieve HbA1c <7% at Week 48|Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.|48 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c <7%.|||Percentage of participants|||Number
2541787|NCT03018938|Secondary|Percentage of Participants Who Achieve HbA1c <7% at Week 24|Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.|24 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c <7%.|||Percentage of participants|||Number
2541788|NCT03018938|Secondary|Change From Baseline to Week 48 in HbA1c|"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.~Least Squares (LS) mean was determined by ANCOVA model with LOCF and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate."|Baseline, 48 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c.|||Percentage of HbA1c||Standard Error|Least Squares Mean
2541789|NCT03018938|Primary|Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)|"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.~Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) and with terms for change from baseline in HbA1c as response, treatment as fixed effect and baseline HbA1c as covariate."|Baseline, 24 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline data for HbA1c.|||Percentage of HbA1c||Standard Error|Least Squares Mean
2541790|NCT03018340|Secondary|Change From Baseline to Week 5 in SIS Score|The Sheehan Irritability Scale is a 7-item patient-reported outcome measure to measure the frequency, severity, and impairment associated with irritability in psychiatric patients. It includes items on: irritability, frustration, edginess/ impatience/ overreaction, moodiness, anger with self, anger with others, and temper. Items are answered on an 11-point rating scale where higher scores indicated greater severity (0=not at all, 10=extremely). Item responses are summed into a total score (range=0-70). Higher scores mean higher irritability.|Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively|"Stage 1: pts randomized to Stage 1, received ≥1 dose of study drug in Stage 1, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 1.~Stage 2: pts randomized to Stage 2, received ≥1 dose of study drug in Stage 2, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 2."|||score on a scale||Standard Error|Mean
2541791|NCT03018340|Secondary|Change From Baseline to Week 5 in BIS-11 Score|The Barratt Impulsiveness Scale-11 is a questionnaire for assessment of the personality/behavioral construct of impulsiveness. It is composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences. Items are scored on a 4-point scale from Rarely/Never (1) to Almost Always/Always (4). Items are summed up to calculate the total score. The BIS-11 total score ranges from 30 to 120. Higher scores denotes more impulsiveness.|Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively|"Stage 1: pts randomized to Stage 1, received ≥1 dose of study drug in Stage 1, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 1.~Stage 2: pts randomized to Stage 2, received ≥1 dose of study drug in Stage 2, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 2."|||score on a scale||Standard Error|Mean
2541966|NCT03014700|Secondary|Chest Tube Output|Volume of chest tube drainage evaluated over first 24 hours post operatively|From administration end of surgery to 24 hours post operatively|Participants who completed the protocol are included in the analysis|||ml/kg||Inter-Quartile Range|Median
2542702|NCT02994056|Primary|Percentage of Participants Who Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event||First dose date up to Week 12|The Safety Analysis Set included all participants who took at least 1 dose of study drug.|||percentage of participants|||Number
2541792|NCT03018340|Secondary|Change From Baseline to Week 5 in MGH-SFI Score|"The Massachusetts General Hospital Sexual Functioning Index is a patient-facing questionnaire that quantifies sexual dysfunction into 5 functional domains (interest in sex, sexual arousal, ability to achieve orgasm, ability to maintain erection [males only], and sexual satisfaction). Patients rate each item using a 6-point scale ranging from 1 (good function) to 6 (poor function). The MGH-SFI score is calculated as the arithmetic mean of the item scores for the 5 domains. The mean MGH-SFI score ranges from a minimum value of 1 to a maximum value of 6. Higher scores denotes worse sexual dysfunction."|Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively|"Stage 1: pts randomized to Stage 1, received ≥1 dose of study drug in Stage 1, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 1.~Stage 2: pts randomized to Stage 2, received ≥1 dose of study drug in Stage 2, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 2."|||score on a scale||Standard Error|Mean
2541793|NCT03018340|Secondary|Change From Baseline to Week 5 in KSS Score|"The Karolinska Sleepiness Scale is a patient-facing 1-item scale that measures the patient's drowsiness. Scoring is based on a 9-point verbally anchored scale ranging from extremely alert (1) to very sleepy, great effort to keep awake, fighting sleep (9). Higher scores denote more drowsiness."|Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively|"Stage 1: pts randomized to Stage 1, received ≥1 dose of study drug in Stage 1, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 1.~Stage 2: pts randomized to Stage 2, received ≥1 dose of study drug in Stage 2, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 2."|||score on a scale||Standard Error|Mean
2541794|NCT03018340|Secondary|Change From Baseline to Week 5 in DAI-10 Score|"The Drug Attitude Inventory-10 is a 6-item patient-facing questionnaire to evaluate a patient's perceptions and experiences of treatment. It contains 6 items that a patient who is fully adherent to prescribed medication would answer as True, and 4 items that a patient who is fully adherent would rate as False. Scores are allocated to each answer and the total score is calculated as the sum. A correct answer is scored +1 and an incorrect answer is scored -1. The total score ranges from -10 to 10 and is the sum of pluses and minuses. A positive total score indicates a positive subjective response (adherent) and a negative total score indicates a negative subjective response (nonadherent). Higher scores denoted better adherence."|Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively|"Stage 1: pts randomized to Stage 1, received ≥1 dose of study drug in Stage 1, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 1.~Stage 2: pts randomized to Stage 2, received ≥1 dose of study drug in Stage 2, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 2."|||score on a scale||Standard Error|Mean
2541795|NCT03018340|Secondary|Change From Baseline to Week 5 in SF-12 Score|The 12-Item Short Form Health Survey is a patient-reported outcome measure that addresses 8 domains of physical functioning, role - physical, bodily pain, general health perceptions, vitality, social functioning, role - emotional, and mental health. Composite scores were obtained representing physical health and mental health composite summaries, Physical Component Summary (PCS) and Mental Component Summary (MCS), respectively. An algorithm was used to generate PCS and MCS for comparison to normative data. In normative data, the mean score was set to 50; thus, scores >50 indicate better physical or mental health than the mean and scores <50 indicate worse health. A higher score is indicative of a better health state.|Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively|"Stage 1: pts randomized to Stage 1, received ≥1 dose of study drug in Stage 1, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 1.~Stage 2: pts randomized to Stage 2, received ≥1 dose of study drug in Stage 2, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 2."|||score on a scale||Standard Error|Mean
2541796|NCT03018340|Secondary|CGI-I Score at Week 5|The Clinical Global Impression- Improvement scale is a 1-item scale, used to rate the global improvement of the patient since beginning of the study from 0 (not assessed) to 7 (very much worse). A higher CGI-I score denotes less improvement in depression.|Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively|"Stage 1: pts randomized to Stage 1, received ≥1 dose of study drug in Stage 1, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 1.~Stage 2: pts randomized to Stage 2, received ≥1 dose of study drug in Stage 2, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 2."|||score on a scale||Standard Error|Least Squares Mean
2541797|NCT03018340|Secondary|Change From Baseline to Week 5 in CGI-S Total Score|The Clinical Global Impression-Severity Scale is a 1-item scale, used to rate the severity of the disorder from 0 (not assessed) to 7 (among the most extremely ill patients). A higher CGI-I score denotes more severe depression.|Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively|"Stage 1: pts randomized to Stage 1, received ≥1 dose of study drug in Stage 1, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 1.~Stage 2: pts randomized to Stage 2, received ≥1 dose of study drug in Stage 2, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 2."|||score on a scale||Standard Error|Mean
2541798|NCT03018340|Secondary|Treatment Response and Remission Rates at the End of 5-week Treatment Period|"The Hamilton Rating Scale for Depression (HAMD-17) is a 17-item scale to assess depression. Each item is rated from least (0) to most frequent or most severe, as applicable, with highest scores of 2 to 4 depending on the item. Items are summed up to calculate the HAMD-17 total score. A higher total score indicates more severe depression.~Treatment response was defined as a reduction from Baseline in HAMD-17 total score of >=50%.~Remission was defined as a HAMD-17 total score <=7."|Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively|"Stage 1: pts randomized to Stage 1, received ≥1 dose of study drug in Stage 1, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 1.~Stage 2: pts randomized to Stage 2, received ≥1 dose of study drug in Stage 2, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 2."|||Participants|||Count of Participants
2541854|NCT03018028|Secondary|Change in Mean Postprandial Increment Over All Meals in SMPG|Change from baseline (week 0) in the average of the post-prandial increments over all meals. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2541799|NCT03018340|Secondary|Change From Baseline to Week 5 in the SDS Total Score|The Sheehan Disability Scale is a 3-item patient-facing questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point scale from 0 (no impairment) to 10 (most severe). The total SDS score ranges from 0 to 10. It is calculated as the arithmetic mean of the scores for all 3 items. A higher score indicates greater disability.|Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively|"Stage 1: pts randomized to Stage 1, received ≥1 dose of study drug in Stage 1, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 1.~Stage 2: pts randomized to Stage 2, received ≥1 dose of study drug in Stage 2, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 2."|||score on a scale||Standard Error|Mean
2541800|NCT03018340|Primary|Change From Baseline to Week 5 in the HAMD-17 Total Score|The Hamilton Rating Scale for Depression (HAMD-17) is a 17-item scale to assess depression. The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. Each item is rated from least (0) to most frequent or most severe, as applicable, with highest scores of 2 to 4, depending on the item. Items are summed up to calculate the HAMD-17 total score. The total score ranges from 0 to 52. A higher total score indicates more severe depression.|Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively|"FAS Stage 1: pts randomized to Stage 1, received ≥1 dose of study drug in Stage 1, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 1.~FAS Stage 2: pts randomized to Stage 2, received ≥1 dose of study drug in Stage 2, and had a baseline value and ≥1 post-baseline value for HAMD-17 total score in Stage 2."|||score on a scale||Standard Error|Mean
2541801|NCT03018223|Secondary|Progression Free Survival (PFS)|Progression-free survival defined by the time interval from transplant to relapse/recurrence, to death or to last follow-up. Reported as percentage of participants who are disease free one year post HCT.|Up to 1 year post HCT||||percentage of participants||95% Confidence Interval|Number
2541802|NCT03018223|Secondary|Overall Survival (OS)|Overall survival is defined as time from transplant to death or last follow-up, and is reported as percentage of surviving participants.|Up to 1 year post HCT||||percentage of participants||95% Confidence Interval|Number
2541803|NCT03018223|Secondary|Incidence of Chronic GVHD|Cumulative incidence of chronic GVHD by 1 year. Chronic GVHD diagnosis follow National Institutes of Health (NIH) Consensus guidelines.|1 year post HCT||||percentage of participants||95% Confidence Interval|Number
2541804|NCT03018223|Primary|Incidence of Grade II-IV Acute Graft vs. Host Disease (GVHD)|Cumulative incidence of grade II-IV acute GVHD by day 100 after HCT. Acute GVHD organ staging and assessment of overall grade will use standard consensus criteria. The cumulative incidence of acute and chronic GVHD will be estimated, considering malignancy relapse and non-relapse death as competing risk events.|100 days post hematopoietic cell transplant (HCT)||||percentage of participants||95% Confidence Interval|Number
2541805|NCT03018106|Primary|Vaginal Irritation|Participants reported vaginal irritation at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.|Baseline, Week 12|The single participant was lost to follow up prior to completing the Week 12 assessment.|||units on a scale|||Number
2541806|NCT03018106|Primary|Vaginal Itching|Participants reported vaginal itching at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.|Baseline, Week 12|The single participant was lost to follow up prior to completing the Week 12 assessment.|||units on a scale|||Number
2541807|NCT03018106|Primary|Vaginal Dryness|Participants reported vaginal dryness at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.|Baseline, Week 12|The single participant was lost to follow up prior to completing the Week 12 assessment.|||units on a scale|||Number
2541808|NCT03018106|Primary|Pain With Sex|Participants reported pain with sex at the Baseline Visit and after 12 weeks of treatment. Participants rated the severity of their symptoms from 0 to 3, where 0 = none, 1 = mild, 2 = moderate and 3 = severe.|Baseline, Week 12|The single participant was lost to follow up prior to completing the Week 12 assessment.|||units on a scale|||Number
2541809|NCT03018106|Primary|Female Sexual Function Index Score|The Female Sexual Function Index (FSFI) is a 19 item questionnaire that asks about sexual function in the prior four weeks. The FSFI was developed for the specific purpose of assessing sexual arousal, orgasm, satisfaction, pain related to sexual functioning in clinical trial participants. Participants answer by selecting between 5-6 question-specific options to rate the degree to which the question fits their experience. Each response option is assigned a point and each question has 0-5 or 1-5 possible points. The points are summed to determine a total score. The total score can range from 2 to 36 and scores equal to or less than 26.55 indicate female sexual dysfunction (FSD).|Baseline, Week 12|The single participant was lost to follow up prior to completing the Week 12 assessment.|||units on a scale|||Number
2541810|NCT03018028|Secondary|Change From Baseline in DTR-QOL: Sub-domains|"DTR-QOL questionnaire is a 29-item patient-reported survey of patient health that measures the the influence of diabetes treatment on HRQoL. DTR-QOL questionnaire measured the HRQoL on 4 domains on individual scale ranges: Burden on social activities and daily activities, Anxiety and dissatisfaction with treatment, Hypoglycemia and Satisfaction with treatment on a 7-point graded response scale. Higher item scores indicate a higher level of HRQoL for items 1-25. For items 26-29 a higher score indicates a lower level of HRQoL. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100. W26 and W52 refer to week 26 and week 52 respectively. Data based on on-treatment without rescue medication observation period was presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication."|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2541899|NCT03016078|Secondary|Number of Participants With Bleeding Caused by Dressing Removal|Nurse/ Investigator evaluate: Bleeding caused by dressing removal (No/Yes)|Daily visits, up to 7 days|The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits..|||Participants|||Count of Participants
2541811|NCT03018028|Secondary|Change From Baseline in DTR-QOL: Total Score|"Diabetes Therapy-Related QOL (DTR-QOL) questionnaire is a 29-item patient-reported survey of patient health that measures the influence of diabetes treatment on HRQoL on 4 domains on individual scale ranges: Burden on social activities and daily activities, Anxiety and dissatisfaction with treatment, Hypoglycemia and Satisfaction with treatment on a 7-point graded response scale. Higher item scores indicate a higher level of HRQoL for items 1-25. For items 26-29 a higher score indicates a lower level of HRQoL. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100. The total score, after simple addition of the item scores, is converted to 0 - 100 (best-case response = 100; worstcase response = 0). Data based on on-treatment without rescue medication observation period is presented."|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data. On-treatment without rescue medication observation period – time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|||Score on a scale||Standard Deviation|Mean
2541812|NCT03018028|Secondary|Change in SF-36: Mental Component Summary (MCS)|Change in short form 36 v2.0 acute domain MCS from baseline (week 0) to week 56. SF- 36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Data based on on-treatment without rescue medication observation period is presented.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data. On-treatment without rescue medication observation period – time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|||Score on a scale||Standard Deviation|Mean
2541813|NCT03018028|Secondary|Change in SF-36: Physical Component Summary (PCS)|Change in short form 36 v2.0 acute domain PCS from baseline (week 0) to week 56. SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. It consists of 2 component summary measures that further summarize 8 health domain scales. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Data based on on-treatment without rescue medication observation period is presented.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data. On-treatment without rescue medication observation period – time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|||Score on a scale||Standard Deviation|Mean
2541814|NCT03018028|Secondary|Change in SF-36: Sub-domains|SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores is presented. A positive change score indicates an improvement since baseline. Data based on on-treatment without rescue medication observation period is presented.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data. On-treatment without rescue medication observation period – time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|||Score on a scale||Standard Deviation|Mean
2541815|NCT03018028|Secondary|Semaglutide Plasma Concentration|"Semaglutide plasma concentration is presented. Samples for pharmacokinetic (PK) analysis were drawn at any time during the visit except for the visit at week 26 where samples were taken both pre-dose and 60−90 minutes post dosing. This endpoint is applicable only to the reporting groups, Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on on-treatment observation period was presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation."|Week 26 and week 52|Overall number of participants analyzed = number of participants with available data.|||Nanomoles per liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2541816|NCT03018028|Secondary|Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes|Number of participants with treatment emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes. Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data based on on-treatment observation period was presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.|Weeks 0 - 57|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Participants|||Count of Participants
2541900|NCT03016078|Secondary|Number of Participants With Dressing Sticking to the Staples/Sutures|Nurse/ Investigator evaluate: Dressing sticks to the staples/sutures (No/Yes)|Daily visits, up to 7 days|The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.|||Participants|||Count of Participants
2541817|NCT03018028|Secondary|Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes|Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation period. Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Data based on on-treatment observation period was presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.|Week 0 - 57|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Episodes|||Number
2541818|NCT03018028|Secondary|Anti-semaglutide Binding Antibody Levels|This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-57). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Weeks 0-57|"Overall number of participants analyzed=number of participants who were found positive for anti-semaglutide antibodies."|||%B/T||Standard Deviation|Mean
2541819|NCT03018028|Secondary|Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)|"Number of participants with the presence or absence (yes/no) of anti-semaglutide neutralising antibodies cross reacting with native GLP-1 in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on the in-trial observation period was presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product."|Week 0 - 57|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Participants|||Count of Participants
2541820|NCT03018028|Secondary|Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)|"Number of participants with the presence or absence (yes/no) of anti-semaglutide binding antibodies cross reacting with native GLP-1 in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on the in-trial observation period was presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product."|Week 0 - 57|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Participants|||Count of Participants
2541821|NCT03018028|Secondary|Anti-semaglutide Neutralising Antibodies (Yes/no)|"Number of participants with the presence or absence (yes/no) of anti-semaglutide neutralising antibodies in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on the in-trial observation period is presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product."|Week 0 - 57|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Participants|||Count of Participants
2541822|NCT03018028|Secondary|Anti-semaglutide Binding Antibodies (Yes/no)|"Number of participants with the presence or absence (yes/no) of anti-semaglutide binding antibodies in blood anytime post-baseline (week 0) and up to week 57. This endpoint is applicable only to the reporting groups Oral semaglutide 3 mg, Oral semaglutide 7 mg and Oral semaglutide 14 mg. Data based on the in-trial observation period was presented. The in-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product."|Week 0 - 57|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Participants|||Count of Participants
2541823|NCT03018028|Secondary|Change in Eye Examination Category|Eye examination was performed by the investigator and categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Data based on in-trial observation period is presented. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week -8, Week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541824|NCT03018028|Secondary|Change in Physical Examination|Physical examination included examination of cardiovascular system, nervous system (central and peripheral), gastrointestinal system including mouth, general appearence, head and neck (head, ears, eyes, nose, throat, neck), lymph node palpation, musculoskeletal system, respiratory system, skin and thyroid gland. Physical examination was performed by the investigator and categorised as normal, abnormal NCS or abnormal CS. Data based on in-trial observation period is presented. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Baseline (Week -8), week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541901|NCT03016078|Secondary|Number of Participants With Leakage of the Dressing|Nurse/ Investigator evaluate: Leakage (No/Yes)|Daily visits, up to 7 days|The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.|||Participants|||Count of Participants
2541825|NCT03018028|Secondary|Change in ECG Evaluation|Electrocardiogram (ECG) was evaluated and interpreted by the investigator and categorised as normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). The number of participants who had shifted from normal, abnormal NCS or abnormal CS ECG results from baseline (week 0) to week 26, week 52 is presented. Data based on in-trial observation period is presented. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541826|NCT03018028|Secondary|Change in Blood Pressure|Change from baseline in blood pressure (systolic [sBP] and diastolic [dBP]). Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2541827|NCT03018028|Secondary|Change in Pulse Rate|Change from baseline in pulse rate. Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Beats per minute (beats/min)||Standard Deviation|Mean
2541828|NCT03018028|Secondary|Change in Lipase (Ratio to Baseine)|Change in lipase (measured as U/L) is presented as ratio to baseline. Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Ratio of lipase||Geometric Coefficient of Variation|Geometric Mean
2541829|NCT03018028|Secondary|Change in Amylase (Ratio to Baseine)|Change in amylase (measured as units per liter [U/L]) is presented as ratio to baseline. Data based on on-treatment observation period is presented. The on-treatment observation period - time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any and excluding any period after premature trial product discontinuation.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Ratio of amylase||Geometric Coefficient of Variation|Geometric Mean
2541830|NCT03018028|Secondary|Number of Treatment-emergent Adverse Events (TEAEs)|A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) with onset in the on-treatment observation period (time period when a participant was on treatment with trial product, including the period after initiation of rescue medication, if any, and excluding any period after premature trial product discontinuation) assessed up to approximately 57 weeks (52 weeks treatment period + 5 weeks follow-up period).|Weeks 0 - 57|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.|||Adverse events|||Number
2541831|NCT03018028|Secondary|Time to Rescue Medication|Presented results are the number of participants who had taken rescue medication anytime from week 0 to week 52. 'Rescue medication': use of new anti-diabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation and before last day on trial product. Time to rescue medication was estimated based on data from on-treatment without rescue medication observation period.|Weeks 0 - 52|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2541832|NCT03018028|Secondary|Time to Additional Anti-diabetic Medication|Presented results are the number of participants who had taken additional anti-diabetic medication anytime from week 0 to week 52. 'Additional anti-diabetic medication': use of new anti-diabetic medication for more than 21 days with the initiation at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Weeks 0 - 52|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2541833|NCT03018028|Secondary|Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No)|Participants losing 10% or more of baseline body weight (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541834|NCT03018028|Secondary|Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No)|Participants losing 5% or more of baseline body weight (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2542521|NCT02998996|Primary|Local Tolerability - Second Dose (Group 1-4 Only)|Local tolerability, as measured by at least one of the administration site reactions swelling, redness, pain and pruritus, regardless of severity.|Pre-dose, and 15 and 120 min after second study drug administration (Visit 3).||||Participants|||Count of Participants
2541835|NCT03018028|Secondary|Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3%|Participants who achieved above or equal to 1% (10.9 mmol/mol) reduction in HbA1c and losing 3% or more of baseline body weight (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541836|NCT03018028|Secondary|Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)|Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 milligrams per deciliter [mg/dL]) with symptoms consistent with hypoglycaemia. Number of participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541837|NCT03018028|Secondary|Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No)|Participants who achieved HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists target (Yes/No). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541838|NCT03018028|Secondary|Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no)|Participants who achieved HbA1c <7.0% (53 millimoles per mole [mmol/mol]) according to American Diabetes Association (ADA) target, at week 26 and week 52. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541839|NCT03018028|Secondary|Change in Beta-cell Function (HOMA-B) (Ratio to Baseline)|Change from baseline (week 0) in beta-cell function (measured as percentage of beta-cell function) by homeostatic model assessment index of beta-cell function is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of beta-cell function||Geometric Coefficient of Variation|Geometric Mean
2541840|NCT03018028|Secondary|Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline)|Change from baseline (week 0) in insulin resistance (measured as percentage of insulin resistance) by homeostatic model assessment index of insulin resistance (HOMA-IR) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of insulin resistance||Geometric Coefficient of Variation|Geometric Mean
2541841|NCT03018028|Secondary|Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline)|Change from baseline (week 0) in fasting pro-insulin/insulin ratio is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of pro-insulin/insulin ratio||Geometric Coefficient of Variation|Geometric Mean
2541842|NCT03018028|Secondary|Change in Fasting Pro-insulin (Ratio to Baseline)|Change from baseline (week 0) in fasting pro-insulin (measured as pmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of pro-insulin||Geometric Coefficient of Variation|Geometric Mean
2541843|NCT03018028|Secondary|Change in Fasting Glucagon (Ratio to Baseline)|Change from baseline (week 0) in fasting glucagon (measured as picograms per milliliter [pg/mL]) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of glucagon||Geometric Coefficient of Variation|Geometric Mean
2541967|NCT03014700|Primary|Total Units of Intraoperative Allogenic Donor Transfusions (ADT) Administered During Procedure Through ICU Arrival.|For our study, 1 donor exposure = 1 unit of blood product transfusion. A blood product includes red blood cells, fresh frozen plasma, cryoprecipitate, and platelets.|From administration of the drug during surgery to ICU arrival postoperatively (up to 24 hours)||||ADT units||Inter-Quartile Range|Median
2541844|NCT03018028|Secondary|Change in Fasting C-peptide (Ratio to Baseline)|Change from baseline (week 0) in fasting C-peptide (measured as nanomoles per liter [nmol/L]) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of C-peptide||Geometric Coefficient of Variation|Geometric Mean
2541845|NCT03018028|Secondary|Change in Fasting Insulin (Ratio to Baseline)|Change from baseline (week 0) in fasting insulin (measured as picomoles per liter [pmol/L]) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of insulin||Geometric Coefficient of Variation|Geometric Mean
2541846|NCT03018028|Secondary|Change in Triglycerides (Ratio to Baseline)|Change from baseline (week 0) in triglycerides (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of triglycerides||Geometric Coefficient of Variation|Geometric Mean
2541847|NCT03018028|Secondary|Change in VLDL Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in very low density lipoprotein (VLDL) cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of VLDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2541848|NCT03018028|Secondary|Change in LDL Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in low density lipoprotein (LDL) cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of LDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2541849|NCT03018028|Secondary|Change in HDL Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in high density lipoprotein (HDL) cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of HDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2541850|NCT03018028|Secondary|Change in Total Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in total cholesterol (measured as mmol/L) is presented as ratio to baseline. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of total cholesterol||Geometric Coefficient of Variation|Geometric Mean
2541851|NCT03018028|Secondary|Change in Waist Circumference|Change from baseline (week 0) in waist circumference. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Centimeters (cm)||Standard Deviation|Mean
2541852|NCT03018028|Secondary|Change in Body Mass Index|Change from baseline (week 0) in body mass index (BMI). BMI was calculated based on body weight and height based on the formulae: BMI kg/m^2 = body weight (kg)/(Height (m) x Height (m)). Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Kilogram per square meter (kg/m^2)||Standard Deviation|Mean
2541853|NCT03018028|Secondary|Change in Body Weight (%)|Relative change (%) from baseline (week 0) in body weight (kg). Data based on on-treatment without resue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Percentage change||Standard Deviation|Mean
2542118|NCT03007966|Secondary|Post-operative Verbal Pain Score at Rest|Assessed on an 11 point (0-10) numeric analog scale with a higher score denoting a worse outcome|24 hrs Post Nerve Block|One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.|||score on a scale||Standard Deviation|Mean
2541855|NCT03018028|Secondary|Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile|Change from baseline (week 0) in mean 7-point self-measured plasma glucose (SMPG) profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2541856|NCT03018028|Secondary|Change in Fasting Plasma Glucose|Change from baseline (week 0) in fasting plasma glucose. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2541857|NCT03018028|Secondary|Change in Body Weight (kg)|Change from baseline (week 0) in body weight. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Kilogram (kg)||Standard Deviation|Mean
2541858|NCT03018028|Secondary|Change in HbA1c (Week 52)|Change from baseline (week 0) to week 52 in HbA1c. Data based on on-treatment without rescue medication observation period is presented. The on-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 52|Overall number of participants analyzed = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2541859|NCT03018028|Primary|Change in HbA1c (Week 26)|Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c). The endpoint was analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period - time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication. The endpoint was also evaluated based on data from the in-trial observation period. In-trial observation period - time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Percentage point of HbA1c||Standard Deviation|Mean
2541860|NCT03017846|Secondary|Number of Patients Achieving Complete Lesion Clearance Compared to Prior Study (NCT02665260)|Comparison of the number of subjects achieving complete lesion clearance at study completion (up to 12 weeks) to the same measure obtained in our previous study (NCT02665260)|At study completion, up to 12 weeks||||Participants|||Count of Participants
2541861|NCT03017846|Secondary|Change in the Total Children's Dermatology Life Quality Index Score|"Change in the Total Children's Dermatology Life Quality Index (CDLQI) given Visit 1 prior to the first treatment and at the last study visit, up to 12 weeks. The CDLQI examines how the patient feels about the symptoms and treatment, as well as how it affects leisure, school, personal relationships, sleep, clothing choices. A total score is calculated.~The total score for the CDLQI scores range:~0-1 = no effect on child's life 2-6 = small effect 7-12 = moderate effect 13-18 = very large effect 19-30 = extremely large effect"|Baseline (At beginning of study, before treatment) and end of study (at study completion, week 12 or at earlier visit if all lesions have cleared)|All patients who were not lost to follow-up.|||score on a scale||Standard Deviation|Mean
2541862|NCT03017846|Secondary|Number of Subjects Who Achieve a Clearance of at Least 90% of Their Molluscum Lesions||At study completion, up to 12 weeks||||Participants|||Count of Participants
2541863|NCT03017846|Primary|Number of Participants With Total Lesion Clearance|100% reduction in baseline lesion count|Assessed at each visit, until final visit on week 12||||Participants|||Count of Participants
2541864|NCT03017612|Secondary|Uncorrected Intermediate Visual Acuity|75% of eyes should achieve uncorrected intermediate visual acuity (80 cm/32 in) of 20/40 or better|at 12 months postoperatively||||Percentage of Implanted Eyes|||Number
2541865|NCT03017612|Secondary|Occurrence of Adverse Events|Any specific adverse event should occur in less than or equal to 5% of eyes.|During the length of the study, up to 24 months||||Occurrence of specific adverse events|||Number
2541866|NCT03017612|Secondary|Percentage of Implanted Eyes With a Postoperative Manifest Refraction Astigmatism That Increased From Baseline by Greater Than 2.00 D|Fewer than 5% of eyes should have postoperative manifest refractive astigmatism that increases from baseline by greater than 2.00 D|At 6 months postoperatively and all subsequent time points up to 24 months||||Percentage of Implanted Eyes|||Number
2541867|NCT03017612|Secondary|Preservation of Best Corrected Visual Acuity|Fewer than 5% of eyes should lose two lines or more of best corrected distance and near visual acuity and less than 1% of eyes with preoperative best corrected visual acuity (BCVA) of 20/20 should have best corrected distance and near visual acuity worse than 20/40|at 6 months postoperatively and all subsequent time points up to 24 months||||Percentage of Implanted Eyes|||Number
2541868|NCT03017612|Primary|Percentage of Implanted Eyes With Improvement in Uncorrected Near Vision|75% of implanted eyes should achieve uncorrected near visual acuity (40cm/16in) of 20/40 or better|12 months postoperatively||||Percentage of Implanted Eyes|||Number
2541869|NCT03017235|Secondary|Clinically Significant Changes in Laboratory Values|Rated by the investigator based on out of range laboratory values|At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy|The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received.|||Participants|||Count of Participants
2541870|NCT03017235|Secondary|Clinically Significant Changes in Electrocardiogram (ECG)|Measured by standard 12-lead ECG. At each visit when an ECG was done, the investigator reviewed and initialed the tracing, which was then stored with the subject's source documents. The baseline ECG performed at the Screening Visit was reviewed for major abnormalities before dosing.|At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy|The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received|||Participants|||Count of Participants
2541871|NCT03017235|Secondary|Clinically Significant Changes in Vital Signs|Blood pressure and pulse will be measured after at least 5 minutes of rest in supine position and after 3 minutes in standing position|From baseline (screening) up to day 28 after colonoscopy|The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received|||Participants|||Count of Participants
2541872|NCT03017235|Secondary|Percentage of Treatment-emergent Adverse Events(AEs)|Collected as any AE that begins during the treatment period defined as the period during which a subject receives IMP. All endoscopy findings were reported as AEs while cancers/malignancies detected on endoscopy were reported as SAEs.|From baseline (screening) up to day 28 after colonoscopy|The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received|||Percentage of adverse events|||Number
2541873|NCT03017235|Secondary|Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations)|Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.|During colonoscopy procedure (5-9 hours after completed treatment)|The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.|||Participants|||Count of Participants
2541874|NCT03017235|Secondary|Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)|Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.|During colonoscopy procedure (5-9 hours after completed treatment)|The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.|||Participants|||Count of Participants
2541875|NCT03017235|Secondary|Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?)|Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.|During colonoscopy procedure (5-9 hours after completed treatment)|The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.|||Participants|||Count of Participants
2541876|NCT03017235|Secondary|Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?)|Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.|During colonoscopy procedure (5-9 hours after completed treatment)|The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.|||Participants|||Count of Participants
2541877|NCT03017235|Secondary|Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?)|Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.|During colonoscopy procedure (5-9 hours after completed treatment)|The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.|||Participants|||Count of Participants
2541878|NCT03017235|Secondary|Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?)|Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.|During colonoscopy procedure (5-9 hours after completed treatment)|The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.|||Participants|||Count of Participants
2541879|NCT03017235|Secondary|Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?)|Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.|During colonoscopy procedure (5-9 hours after completed treatment)|The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.|||Participants|||Count of Participants
2541880|NCT03017235|Secondary|Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?)|Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.|During colonoscopy procedure (5-9 hours after completed treatment)|The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.|||Participants|||Count of Participants
2541881|NCT03017235|Secondary|Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?)|Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.|During colonoscopy procedure (5-9 hours after completed treatment)|The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.|||Participants|||Count of Participants
2541882|NCT03017235|Secondary|Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?)|Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.|During colonoscopy procedure (5-9 hours after completed treatment)|The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.|||Participants|||Count of Participants
2541883|NCT03017235|Secondary|Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?)|Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. Subjects in response to questions could provide multiple response if applicable.|During colonoscopy procedure (5-9 hours after completed treatment)|The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.|||Participants|||Count of Participants
2541884|NCT03017235|Secondary|Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?)|Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.|During colonoscopy procedure (5-9 hours after completed treatment)|The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.|||Participants|||Count of Participants
2541885|NCT03017235|Secondary|Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?)|Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.|During colonoscopy procedure (5-9 hours after completed treatment)|The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.|||Participants|||Count of Participants
2541886|NCT03017235|Secondary|Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)|Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.|During colonoscopy procedure (5-9 hours after completed treatment)|The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.|||Participants|||Count of Participants
2541887|NCT03017235|Secondary|Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)|Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated‎ Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure|During colonoscopy procedure (5-9 hours after completed treatment)|The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.|||Participants|||Count of Participants
2541902|NCT03016078|Primary|Number of Participants With Damage to the Incision and Surrounding Skin|"The primary outcome is damage to the incision and surrounding skin from operation day to last visit in terms of:~Blistering (Yes/No) by visit~Redness under dressing (Yes/No) by visit~Redness outside dressing (Yes/No) by visit~Maceration under dressing (Yes/No) by visit~Maceration outside dressing (Yes/No) by visit"|Daily visits, up to 7 days|The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.|||Participants|||Count of Participants
2541888|NCT03017235|Secondary|Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon|"The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the left segment of the colon was determined.~The BBPS scale:~0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid."|During colonoscopy procedure (5-9 hours after completed treatment)|The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.|||Percentage of subjects||95% Confidence Interval|Number
2541889|NCT03017235|Secondary|Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon|"The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the transverse segment of the colon was determined.~The BBPS scale:~0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid."|During colonoscopy procedure (5-9 hours after completed treatment)|The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.|||Percentage of subjects||95% Confidence Interval|Number
2541890|NCT03017235|Secondary|Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon|"The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the right segment of the colon was determined.~The BBPS scale:~0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid."|During colonoscopy procedure (5-9 hours after completed treatment)|The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.|||Percentage of subjects||95% Confidence Interval|Number
2541891|NCT03017235|Primary|"Percentage of Subjects Classified as a Responder Defined by Excellent or Good"|"The efficacy of overall colon cleansing in terms of responders was measured by a blinded endoscopist using the Modified Aronchick Scale. Modified Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is excellent or good on this 4-point scale."|During colonoscopy procedure (5-9 hours after completed treatment)|The primary efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.|||Percentage of participants||95% Confidence Interval|Number
2541892|NCT03017040|Primary|DASH Questionnaire|The DASH questionnaire will help the investigators determine the level of disability subjects face from the wrist injury.|at enrollment|The paper-based questionnaire was not scored and tallied, thus not analyzed.||||||
2541893|NCT03017040|Primary|SF-12 Patient Questionnaire|The SF-12 questionnaire will help the investigators determine how well subjects are able to do usual activities|at enrollment|The paper-based questionnaire was not scored and tallied, thus not analyzed.||||||
2541894|NCT03017040|Primary|Patient Rated Wrist Evaluation (PRWE)|The questionnaire will help the investigators determine how much difficulty the subject has had with the injured wrist in the past week.|at enrollment|The paper-based questionnaire was not scored and tallied, thus not analyzed.||||||
2541895|NCT03016078|Secondary|Residuals of the Dressing Material in the Wound or Surrounding Skin at Any Visit (for Patients With at Least One Dressing Change)|"Residuals of the dressing material in the wound or surrounding skin at any visit (for patients with at least one dressing change).~Nurse/ Investigator evaluate with No/Yes"|Daily visits, up to 7 days|The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.|||Participants|||Count of Participants
2541896|NCT03016078|Secondary|Evaluation of the Dressing Capacity of Handling Blood|Nurse or Investigator evaluate: Poor, Good, Very Good,Very Good, Excellent on a Likert scale.|Daily visits, up to 7 days|The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.|||Participants|||Count of Participants
2541897|NCT03016078|Secondary|Number of Dressing Changes Per Subject|To evaluate the number of dressing changes per subject|Daily visits, up to 7 days|The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.|||Number of dressing changes per subject||Standard Deviation|Mean
2541898|NCT03016078|Secondary|Participants' Dressing Wear Time (Days)|The number of days the dressing can stay on are evaluated|7 days|The ITT population included all subjects who underwent at least one post-enrolment treatment. The number of participants analyzed varies due to that no data was captured at some visits, since the dressing was not changed at all visits.|||days||Standard Deviation|Mean
2541956|NCT03015142|Secondary|Patient Radiation Dose|Radiation dose measured in Air Kerma (AK)|During surgery, mean 6.71 hours||||mGy (AK)||Standard Deviation|Mean
2541903|NCT03015220|Secondary|Diabetes Therapy-Related Quality of Life (DTR-QoL): Total Score and Scores for the 4 Domains|"DTR-QoL questionnaire is a 29-item patient-reported survey of patient health that measures the influence of diabetes treatment on health related-QoL on 4 domains on individual scale ranges: Burden on social activities and daily activities, Anxiety and dissatisfaction with treatment, Hypoglycemia and Satisfaction with treatment on a 7-point graded response scale. The domain score is calculated from the mean score of the attribute items, and the scoring range is converted to 0 - 100 (best-case response = 100; worst case response = 0). The total score, after simple addition of the item scores, is converted to 0 - 100 (best-case response = 100; worst case response = 0). Change from baseline (week 0) in the scores were evaluated at week 26, week 52. Data based on in-trial observation period is presented. W26 and W52 refer to week 26 and week 52 respectively."|week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2541904|NCT03015220|Secondary|Change in SF-36v2 (Acute Version) Health Survey Scores: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)|SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2541905|NCT03015220|Secondary|Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes|Participants with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 83 (78-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Weeks 0-57|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Participants|||Count of Participants
2541906|NCT03015220|Secondary|Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes|Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Weeks 0-57|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Episodes|||Number
2541907|NCT03015220|Secondary|Change in Eye Examination Category|Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week -2, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541908|NCT03015220|Secondary|Change in Physical Examination|Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2), week 26 and weeks 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.|Week -2, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541909|NCT03015220|Secondary|Change in ECG Evaluation|Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and 52. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2542119|NCT03007966|Secondary|Post-operative Verbal Pain Score at Rest|Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome|8 hrs Post Nerve Block||||score on a scale||Standard Deviation|Mean
2541910|NCT03015220|Secondary|Change in Blood Pressure|Change from baseline (week 0) in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2541911|NCT03015220|Secondary|Change in Pulse Rate|Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Beats per minute (beats/min)||Standard Deviation|Mean
2541912|NCT03015220|Secondary|Change in Lipase (Ratio to Baseline)|Change from baseline (week 0) in lipase (measured as U/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Ratio of lipase||Geometric Coefficient of Variation|Geometric Mean
2541913|NCT03015220|Secondary|Change in Amylase (Ratio to Baseline)|Change from baseline (week 0) in amylase (measured as units per liter [U/L]) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Ratio of amylase||Geometric Coefficient of Variation|Geometric Mean
2541914|NCT03015220|Secondary|Time to Rescue Medication|Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Weeks 0-52|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2541915|NCT03015220|Secondary|Time to Additional Anti-diabetic Medication|Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-52|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2541916|NCT03015220|Secondary|Participants Who Achieve Weight Loss More Than or Equal to 10% (Yes/No)|Participants who achieved weight loss more than or equal to 10% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541917|NCT03015220|Secondary|Participants Who Achieve Weight Loss More Than or Equal to 5% (Yes/No).|Participants who achieved weight loss more than or equal to 5% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541918|NCT03015220|Secondary|Participants Who Achieve HbA1c Reduction More Than or Equal to 1% (10.9 mmol/Mol) and Weight Loss More Than or Equal to 3% (Yes/No)|Participants who achieved HbA1c reduction more than or equal to 1% (10.9 mmol/mol) and weight loss more than or equal to 3% (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541957|NCT03015142|Secondary|System Usability Score (SUS Score)|The SUS is a validated standard questionnaire to evaluate the system usability. Score varies between 0 and 100 (0 meaning the lowest usability score, 100 meaning highest usability score).|End of all surgeries|Four independent physicians provided feedback via a validated system usability score (SUS)|||Scores on a scale||Standard Deviation|Mean
2541958|NCT03015142|Secondary|Length of Hospitalization||From start of the interventional procedure until hospital discharge, approximately 5.3 days||||Days||Standard Deviation|Mean
2541919|NCT03015220|Secondary|Participants Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)|Participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia episodes and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541920|NCT03015220|Secondary|Participants Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target (Yes/No)|Participants who achieved HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) target (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541921|NCT03015220|Secondary|Participants Who Achieve HbA1c Below 7% (53 mmol/Mol), American Diabetes Association Target (Yes/No)|Participants who achieved HbA1c below 7.0% (53 millimoles per mole [mmol/mol]) according to American Diabetes Association (ADA) target (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2541922|NCT03015220|Secondary|Change in Fasting Triglyceride (Ratio to Baseline)|Change from baseline (week 0) in fasting triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of fasting triglycerides||Geometric Coefficient of Variation|Geometric Mean
2541923|NCT03015220|Secondary|Change in Fasting Very-low Density Lipoprotein (VLDL) - Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in fasting very-low density lipoprotein (VLDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of fasting VLDL||Geometric Coefficient of Variation|Geometric Mean
2541924|NCT03015220|Secondary|Change in Fasting High-density Lipoprotein (HDL) - Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in fasting high-density lipoprotein (HDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of fasting HDL||Geometric Coefficient of Variation|Geometric Mean
2541925|NCT03015220|Secondary|Change in Fasting Low-density Lipoprotein (LDL) - Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in fasting low-density lipoprotein (LDL) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of fasting LDL||Geometric Coefficient of Variation|Geometric Mean
2541926|NCT03015220|Secondary|Change in Fasting Total Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in fasting total cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of fasting total cholesterol||Geometric Coefficient of Variation|Geometric Mean
2541927|NCT03015220|Secondary|Change in Waist Circumference|Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Centimeters (cm)||Standard Deviation|Mean
2541959|NCT03015142|Secondary|Time to Insert Pedicle Screw||Intraoperative, mean 5.18 hours||||Minutes||Standard Deviation|Mean
2541960|NCT03015142|Secondary|Procedure Time|Time from skin incision to skin closure|During surgery, mean 6.71 hours||||Hours||Standard Deviation|Mean
2541928|NCT03015220|Secondary|Change in Body Mass Index (BMI)|Change from baseline (week 0) in BMI was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Kilogram per square meter (kg/m^2)||Standard Deviation|Mean
2541929|NCT03015220|Secondary|Change in Body Weight (%)|Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Percentage change||Standard Deviation|Mean
2541930|NCT03015220|Secondary|Change in Body Weight (kg)|Change from baseline (week 0) in body weight was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||kg||Standard Deviation|Mean
2541931|NCT03015220|Secondary|Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals|Change from baseline (week 0) in the average of the post-prandial increments over all meals was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2541932|NCT03015220|Secondary|Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile|Change from baseline (week 0) in mean 7-point SMPG profile was evaluated at weeks 26 and 52. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2541933|NCT03015220|Secondary|Change in Fasting Plasma Glucose|Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2541934|NCT03015220|Secondary|Change in HbA1c|Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2541935|NCT03015220|Primary|Number of Treatment-emergent Adverse Events (TEAEs)|Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Weeks 0-57|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.|||Events|||Number
2541936|NCT03015181|Secondary|Number of Multiple Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS|Serum samples collected 4 weeks, 28 weeks and 32 weeks after VRC07-523LS administration|Weeks 4, 28 and 32 after the first product administration|Subjects who received multiple doses of VRC07-523LS via SC or IV administration. One subject in Group 7 who only received a single dose was not included in this analysis but was analyzed with Group 4 (single dose at 20 mg/kg IV).|||Participants|||Count of Participants
2541937|NCT03015181|Secondary|Number of Single Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS|Serum samples collected 4 weeks and 8 weeks after VRC07-523LS administration|Weeks 4 and 8 post product administration|Subjects who received a single dose of VRC07-523LS via SC or IV administration. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4.|||Participants|||Count of Participants
2541961|NCT03015142|Primary|Clinical Accuracy of Pedicle Screw Placement Using New Image-guidance Software|"Clinical accuracy of pedicle screw placements using new image-guidance software assessed by three independent reviewers. Accuracy grading was done per Gertzbein classification.~Gertzbein classification: grade 0 = breach 0 mm, grade 1 = breach < 2 mm, grade 2 = breach 2-4 mm, grade 3 = breach > 4 mm.~Values in the data table represent the percentage of screw placements that were determined accurate by three independent reviewers."|During surgery, mean 6.71 hours|"20 subjects were treated with the new image-guidance software. One was treated in the conventional method placing screws by free-hand method.~Total of 253 screws (163 in thoracic, 77 in lumbar and 13 in sacral regions) were placed with new image-guidance software."|||Percentage of screw placements|Screw placements|95% Confidence Interval|Number
2541938|NCT03015181|Secondary|Overall IV Half-life (T1/2) of VRC07-523LS|"Half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.~Serum was collected at the following time points:~Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4 and 8 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4 and 8 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2, 4 and 8 post infusion"|Administration (0h) to 56 days post product administration|Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).|||days||Standard Deviation|Mean
2541939|NCT03015181|Secondary|VRC07-523LS Clearance Rate|"Rate of VRC07-523LS elimination divided by the plasma VRC07-523LS concentration; determined based on the summary PK curve for each study group.~Serum was collected at the following time points:~Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2 and 4 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2 and 4 post infusion"|Administration (0h) to 28 days post product administration|Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). Value following SC administration represents CL/F (apparent clearance).|||mL/day||Standard Deviation|Mean
2541940|NCT03015181|Secondary|Area Under the Curve (AUC0-84D): Multiple Dose Groups|"The AUC0-84D represents the total drug exposure in 84 days after VRC07-523LS administration; it is determined based on the summary PK curve for each group.~Serum was collected at the following time points for Groups 6 and 7 after Dose 1 and Dose 3:~Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 6, Dose 3: Pre-injection (Week 24) and 72 hours post injection, followed by Weeks 25-28 and every 4 weeks up to 48 weeks post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hrs post infusion, followed by Weeks 1, 2, 4 and 8 post infusion; Group 7, Dose 3: Pre-infusion (Week 24), end of infusion and 1 hour post infusion followed by Weeks 25-28 and every 4 weeks up to 48 weeks post infusion"|Administration (0h) up to 84 days after each product administration|Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). For Dose 3, value calculated from 4 subjects per group.|||µg*d/mL||Standard Deviation|Mean
2541941|NCT03015181|Secondary|Area Under the Curve (AUC(0-inf)): Single Dose Groups|"The total area under the curve (AUC(inf)) was taken as the sum of the observed AUC up to the final concentration (AUC(obs)) plus the AUC after the final concentration (AUC(Clast-inf)) where AUC(Clast-inf) was estimated as Clast/lz.~Serum was collected at the following time points:~Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection"|Administration (0h) to 24 weeks post product administration|Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).|||µg*d/mL||Standard Deviation|Mean
2541942|NCT03015181|Secondary|12 Week Mean Serum Concentration of VRC07-523LS: Multiple Dose Groups|The mean of individual subject VRC07-523LS serum concentrations by administered dose group|Up to 12 weeks after each product administration|Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). For Dose 3, values calculated from 4 subjects per group.|||µg/mL||Standard Deviation|Mean
2541943|NCT03015181|Secondary|12 Week Mean Serum Concentration of VRC07-523LS: Single Dose Groups|The mean of individual subject VRC07-523LS serum concentrations by administered dose group|Week 12 post product administration|Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).|||µg/mL||Standard Deviation|Mean
2541944|NCT03015181|Secondary|4 Week Mean Serum Concentration of VRC07-523LS|The mean of individual subject VRC07-523LS serum concentrations by administered dose group|Week 4 post product administration|Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).|||µg/mL||Standard Deviation|Mean
2541945|NCT03015181|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) of VRC07-523LS|"Tmax is the time it takes to reach Cmax of VRC07-523LS after it has been administered; it is determined based on the summary PK curve for each study group~Serum was collected at the following time points:~Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2, 4 and 8 post infusion"|Through 24 weeks after the last product administration for Groups 1-5 and through 8 weeks after the last product administration for Groups 6 and 7|Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).|||days||Standard Deviation|Mean
2541946|NCT03015181|Secondary|Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Multiple Dose Groups|"Cmax is the peak serum concentration that VRC07-523LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.~Serum was collected at the following time points for Groups 6 and 7 after Dose 1 and Dose 3:~Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 6, Dose 3: Pre-injection (Week 24) and 72 hours post injection, followed by Weeks 25-28 and every 4 weeks up to 48 weeks post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hrs post infusion, followed by Weeks 1, 2, 4 and 8 post infusion; Group 7, Dose 3: Pre-infusion (Week 24), end of infusion and 1 hour post infusion followed by Weeks 25-28 and every 4 weeks up to 48 weeks post infusion"|Through 24 weeks after the last product administration|Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). For Dose 3, values calculated from 4 subjects per group.|||µg/mL||Standard Deviation|Mean
2541947|NCT03015181|Secondary|Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Single Dose Groups|"Cmax is the peak serum concentration that VRC07-523LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.~Serum was collected at the following time points:~Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection"|Up to 24 weeks post product administration|Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).|||µg/mL||Standard Deviation|Mean
2541948|NCT03015181|Primary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events (SAEs) collected during the period from study product administration at Day 0 through 24 weeks after the last product administration.|Through 24 weeks after the last product administration|Subjects who received VRC07-523LS (N=25), where “N” signifies number of subjects analyzed for this outcome measure.|||Participants|||Count of Participants
2541949|NCT03015181|Primary|Number of Subjects Reporting 1 or More Unsolicited Non-Serious Adverse Events|Unsolicited adverse events (AEs) collected during the period from study product administration at Day 0 through 56 days after the last product administration. After the indicated time period through the last expected study visit at 24 weeks after the last product administration, only new chronic medical conditions collected as unsolicited AEs. The number reported is the number of subjects who experienced at least one AE in the reporting period. A subject with multiple experiences of the same event is counted once using the event of worst severity.|Through 24 weeks after the last product administration|Subjects who received VRC07-523LS (N=25), where “N” signifies number of subjects analyzed for this outcome measure.|||Participants|||Count of Participants
2541950|NCT03015181|Primary|Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration|"Local symptoms assessed and recorded by the clinicians. Solicited local symptoms include pain/tenderness, swelling, redness, bruising, and pruritus (itchiness) at the product administration site. Clinicians assessed the study product administration site for local symptoms on the day of product administration after completion of the administration and on Days 1, 2 and 7 post administration. Subjects were counted once for each symptom at the worst severity if they experienced the symptom at any severity during the reporting period. If symptoms were experienced, clinicians collected resolution information for any symptom that was not resolved within 7 days. The number reported for Any Local Symptom is the number of subjects reporting any local symptom at the worst severity. Solicited reactogenicity recorded without an attribution assessment. If symptoms were reported, grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.0."|7 days after each product administration|Subjects who received VRC07-523LS (N=25), where “N” signifies number of subjects analyzed for this outcome measure. Groups 1, 2, 4, 5 and 7 are IV administration groups and Groups 3 and 6 are SC administration groups, with Groups 6 and 7 receiving multiple doses.|||Participants|||Count of Participants
2541951|NCT03015181|Primary|Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration|"Subjects recorded 3-day systemic symptoms in a diary after each study product administration. Solicited systemic symptoms include: unusually tired/feeling unwell, muscles aches, headache, chills, nausea, temperature and joint pain. Subjects recorded highest measured temperature daily. Clinicians reviewed the diary with the subject and collected resolution information for any symptoms that were not resolved within 3 days. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for Any Systemic Symptom is the number of subjects reporting any systemic symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.0."|3 days after each product administration|Subjects who received VRC07-523LS (N=25), where “N” signifies number of subjects analyzed for this outcome measure. Groups 1, 2, 4, 5 and 7 are IV administration groups and Groups 3 and 6 are SC administration groups, with Groups 6 and 7 receiving multiple doses.|||Participants|||Count of Participants
2541952|NCT03015142|Secondary|Adverse Events, Adverse Device Effects and Device Deficiencies That Could Have Led to a Serious Adverse Event||From start of enrollment until hospital discharge, approximately 51 days|21 patients enrolled, 20 patients treated with new image-guidance software|||Events|||Number
2541953|NCT03015142|Secondary|Procedure Related Complications|Complication is leading to invasive intervention (e.g. blood sample, invasive intervention, IV/IM medication).|During surgery, mean 6.71 hours||||Procedure related complications|||Number
2541954|NCT03015142|Secondary|Radiation Dose (Effective Dose) Received by Operator||During surgery, mean 6.71 hours|There were 2 cases out of the 20 patients were the dosage information was missing.|||μSv||Standard Deviation|Mean
2541955|NCT03015142|Secondary|Patient Radiation Dose|Radiation dose measured in Dose Area Product (DAP)|During surgery, mean 6.71 hours||||Gy.cm^2 (DAP)||Standard Deviation|Mean
2541968|NCT03014674|Secondary|Number of Participants With Positive Neutralizing Antibodies|Blood samples were collected for the determination of positive neutralizing antibodies. A neutralizing antibody assay was performed. Neutralizing antibody test was only carried out for participants who have had a positive confirmatory binding antibody test result at visit. A participant was considered positive if they had at least one positive post-Baseline neutralizing antibody result. Number of participants with positive neutralizing antibodies at any time post-Baseline are presented here. Only those participants available at the specified time points were analyzed.|Up to Day 85|All Treated Subjects (Safety) Population|||Participants|||Number
2541969|NCT03014674|Secondary|Number of Participants With Positive Anti-mepolizumab Binding Antibodies|Blood samples were collected for the determination of anti-mepolizumab antibodies. A binding anti-drug antibody (ADA) assay was performed. There were three tiered analysis: screening, confirmation and titration. The results of binding ADA were categorized as negative, transient positive (defined as a single confirmatory positive immunogenic response that does not occur at the final study assessment) or persistent positive (defined as a confirmatory positive immunogenic response for at least 2 consecutive assessments excluding the Screening visit, or a single result at the final study assessment). A participant was considered positive if they had at least one positive post-Baseline ADA result. Number of participants with positive anti-mepolizumab antibodies at any time post-Baseline are presented here. Only those participants available at the specified time points were analyzed.|Up to Day 85|All Treated Subjects (Safety) Population|||Participants|||Number
2541970|NCT03014674|Secondary|Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings|Single measurements of 12-lead ECGs were obtained after 5 minutes of rest in a supine position for the participant. ECG was performed on Day 1 and Day 85 using an automated ECG machine. Baseline values for each assessment was the latest available assessment prior to receiving the single dose of mepolizumab. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Participants with abnormal ECG findings that are clinically not significant and clinically significant data has been presented here. The data of worst case post-Baseline is presented here. Only those participants available at the specified time points were analyzed.|Baseline and Day 85|All Treated Subjects (Safety) Population|||Participants|||Number
2541971|NCT03014674|Secondary|Change From Baseline in Respiratory Rate|Respiratory rate was measured in supine position after 5 minutes rest. Baseline values for each assessment was the latest available assessment prior to receiving the single dose of mepolizumab. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline and up to Day 85|All Treated Subjects (Safety) Population|||breaths per minute||Standard Deviation|Mean
2541972|NCT03014674|Secondary|Change From Baseline in Temperature|Temperature was measured in supine position after 5 minutes rest. Baseline values for each assessment was the latest available assessment prior to receiving the single dose of mepolizumab. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline and up to Day 85|All Treated Subjects (Safety) Population|||degree Celsius||Standard Deviation|Mean
2541973|NCT03014674|Secondary|Change From Baseline in Pulse Rate|Pulse rate was measured in supine position after 5 minutes rest. Baseline values for each assessment was the latest available assessment prior to receiving the single dose of mepolizumab. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline and up to Day 85|All Treated Subjects (Safety) Population|||Beats per minute||Standard Deviation|Mean
2541974|NCT03014674|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|SBP and DBP were measured in supine position after 5 minutes rest. Baseline values for each assessment was the latest available assessment prior to receiving the single dose of mepolizumab. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline and up to Day 85|All Treated Subjects (Safety) Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2541975|NCT03014674|Secondary|Number of Participants With Clinical Chemistry Parameters Shifts From Baseline Relative to Normal Range|"Blood samples were collected to evaluate clinical chemistry parameters, which included assessment of creatinine, creatine kinase, glucose, protein, potassium, urea, sodium, calcium, alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), direct bilirubin (D.bili) and bilirubin, and albumin. Participants were counted in the worst case category that their value changes to Low, Normal or High. Participants whose value category was unchanged or whose value became normal, were recorded in the To Normal or No Change category. The worst case post-Baseline values has been reported. Only those participants with data available at the specified data points were analyzed. For the category to low  NA indicates data was not available as the lower limit of normal is zero for this parameter."|Up to Day 85|All Treated Subjects (Safety) Population|||Participants|||Number
2541976|NCT03014674|Secondary|Number of Participants With Hematology Parameters Shifts From Baseline Relative to Normal Range|"Hematology parameters included assessment of platelet count, erythrocytes, leukocytes, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin and hematocrit. Participants were counted in the worst case category that their value changes to Low, Normal or High. Participants whose value category was unchanged or whose value became normal, were recorded in the To Normal or No Change category. The worst case post-Baseline values has been reported. For basophils the to low category is not applicable (NA) as the lower limit of normal is zero for this parameter."|Up to Day 85|All Treated Subjects (Safety) Population|||Participants|||Number
2541977|NCT03014674|Secondary|Number of Participants With On-treatment Systemic Reactions and Injection Site Reactions|Adverse events of special interest like local injection site reactions and systemic reactions like allergic Type I hypersensitivity were reported along with AEs and SAEs. Participants with local injection site reaction and Allergic Type I hypersensitivity systemic reactions are reported here.|Up to 28 days post-dose|All Treated Subjects (Safety) Population|||Participants|||Number
2541978|NCT03014674|Secondary|Number of Participants With On-treatment Non-serious Adverse Events (AEs) and Serious AEs (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or events associated with liver injury and impaired liver function were categorized as SAE. All Treated Subjects (Safety) comprised of all participants who received mepolizumab. Participants with non-serious AEs (3 percentage threshold) and SAEs has been reported.|Up to 28 days post-dose|All Treated Subjects (Safety) Population|||Participants|||Number
2541979|NCT03014674|Secondary|Percentage of AUC(0-inf) Obtained by Extrapolation (% AUCex) of Mepolizumab|Blood samples were collected at indicated time points. Percentage AUCex following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product. Only those participants with data available were analyzed.|Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dose|PK Population|||Percentage||Geometric Coefficient of Variation|Geometric Mean
2541980|NCT03014674|Secondary|Terminal Phase Half-life (t½) of Mepolizumab|Blood samples were collected at indicated time points for calculating t½. t½ following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product. Only those participants with data available were analyzed.|Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dose|PK Population|||Days||Geometric Coefficient of Variation|Geometric Mean
2541981|NCT03014674|Secondary|Terminal Phase Elimination Rate Constant (Lambda z) of Mepolizumab|Blood samples were collected at indicated time points. Lambda z following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product. Only those participants with data available were analyzed.|Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dose|PK Population|||Per hours||Geometric Coefficient of Variation|Geometric Mean
2541982|NCT03014674|Secondary|Apparent Volume of Distribution (Vd/F) of Mepolizumab|Blood samples were collected at indicated time points. Vd/F following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product. Only those participants with data available were analyzed.|Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dose|PK Population|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
2541983|NCT03014674|Secondary|Apparent Clearance (CL/F) of Mepolizumab|Blood samples were collected at indicated time points . CL/F following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product. Only those participants with data available were analyzed.|Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dose|PK Population|||Liters per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2541984|NCT03014674|Secondary|Time to Cmax (Tmax) and Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) of Mepolizumab|Blood samples were collected at indicated time points. Tmax and tlast following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product.|Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dose|PK Population|||Days||Full Range|Median
2541985|NCT03014674|Primary|Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]), AUC From Time Zero Extrapolated to Infinite Time (AUC[0-inf]) of Mepolizumab|Blood samples were collected at indicated time points. AUC(0-t) and AUC(0-inf) following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with lyophilized drug product. Fixed effects analysis of covariance model was used for analysis. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).|Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dose|PK Population|||Days*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2541986|NCT03014674|Primary|Maximum Observed Plasma Concentration (Cmax) of Mepolizumab|Blood samples were collected at indicated time points. Cmax following a single dose administration of liquid mepolizumab using a safety syringe and an autoinjector were compared with reconstituted lyophilized drug product from the vial. Pharmacokinetic (PK) Population comprised of all participants receiving study drug for whom a pharmacokinetic sample was obtained and analyzed.|Day 1 (pre-dose, 2 hours, and 8 hours post-dose), Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 22, 29, 43, 57 and 85 post-dose|PK Population|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2541987|NCT03014479|Secondary|Number of Participants With Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes)||Up to 12 weeks|Safety Analysis Set: All participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
2541988|NCT03014479|Secondary|Duration of Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes)|The investigators checked any hospitalization of study participants for type 2 diabetes after the first administration of the study drug or comparative drug (excluding educational hospitalization without worsening of diabetes).|Up to 12 weeks|There were no participants with hospitalization related to type 2 diabetes mellitus during this study.||||||
2541989|NCT03014479|Secondary|Number of Participants Reporting One or More Hypoglycemia||Up to 12 weeks|Safety Analysis Set: All participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
2542046|NCT03011099|Primary|Change in Energy Expenditure During Walking as Assessed by Oxygen Cost|Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight.20 Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2).|baseline, week 4|The metabolic expenditure was only measured for two subjects who completed the Robotic exoskeleton training at the end of the study. The equipment to use metabolic expenditure was not available at that time of enrollment of the population at the beginning of the study. Therefore data was only collected once the equipment became operational.|||ml/min/kg||Standard Deviation|Mean
2541990|NCT03014479|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to 12 weeks|Safety Analysis Set: All participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
2541991|NCT03014479|Secondary|Change From Baseline in Score Per Question in the the DTSQ at the End of Study|The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.|Baseline (Week 0), up to end of study (Week 12)|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis.|||Units on a Scale||Standard Deviation|Mean
2541992|NCT03014479|Secondary|Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study|DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.|Baseline (Week 0), up to end of study (Week 12)|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||Units on a Scale||Standard Deviation|Mean
2541993|NCT03014479|Secondary|Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Number of Doses of the Study Drug or Comparative Drug (Once Weekly, Once Daily or Twice Daily) at Baseline|The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.|Baseline (Week 0), up to the end of study (Week 12)|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given population.|||Units on a Scale||Standard Deviation|Mean
2541994|NCT03014479|Secondary|Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Number of Doses of the Study Drug or Comparative Drug (Once Weekly, Once Daily or Twice Daily) at Baseline|DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.|Baseline (Week 0), up to the end of study (Week 12)|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given population.|||Units on a Scale||Standard Deviation|Mean
2541995|NCT03014479|Secondary|Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Total Number of Daily Tablets of Medication for Treatment of Comorbidities (<2 Tablets or ≥2 Tablets) at Baseline|The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.|Baseline (Week 0), up to the end of study (Week 12)|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. This outcome measure was analyzed with FAS in participants who had any medication for concurrent condition at baseline.|||Units on a Scale||Standard Deviation|Mean
2541996|NCT03014479|Secondary|Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Total Number of Daily Tablets of Medication for Treatment of Comorbidities (<2 Tablets or ≥2 Tablets) at Baseline|DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.|Baseline (Week 0), up to the end of study (Week 12)|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. This outcome measure was analyzed with FAS in participants who had any medication for concurrent condition at baseline.|||Units on a Scale||Standard Deviation|Mean
2541997|NCT03014479|Secondary|Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Number of Daily Doses of Medication for Treatment of Comorbidities (<2 Times or ≥2 Times) at Baseline|The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.|Baseline (Week 0), up to the end of study (Week 12)|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. This outcome measure was analyzed with FAS in participants who had any medication for concurrent condition at baseline.|||Units on a Scale||Standard Deviation|Mean
2541998|NCT03014479|Secondary|Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Number of Daily Doses of Medication for Treatment of Comorbidities (<2 Times or ≥2 Times) at Baseline|DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.|Baseline (Week 0), up to the end of study (Week 12)|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. This outcome measure was analyzed with FAS in participants who had any medication for concurrent condition at baseline.|||Units on a Scale||Standard Deviation|Mean
2541999|NCT03014479|Secondary|Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Use of Medication for Treatment of Comorbidities at Baseline|The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences. Reported data was the score stratified by the use of medication for treatment of comorbidities at baseline (Used/ Not used).|Baseline (Week 0), up to the end of study (Week 12)|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis.|||Units on a Scale||Standard Deviation|Mean
2542000|NCT03014479|Secondary|Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Use of Medication for Treatment of Comorbidities at Baseline|DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL. Reported data was the score stratified by the use of medication for treatment of comorbidities at baseline (Used/ Not used).|Baseline (Week 0), up to the end of study (Week 12)|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||Units on a Scale||Standard Deviation|Mean
2542001|NCT03014479|Secondary|Change From Baseline in Total Score for Questions About Treatment Satisfaction in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at Each Assessment Time Point|The DTSQ is a self-reported instrument consists of 6 questions about treatment satisfaction and 2 questions regarding blood sugar level. Each question answered on a 7-point Likert scale from 0 to 6, based on concern with the diabetes treatment and experiences in the past few weeks. Higher total score for questions about treatment satisfaction indicate greater satisfaction with treatment and experiences.|Baseline (Week 0), up to Week 4, 12 and the end of study (Week 12)|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Units on a Scale||Standard Deviation|Mean
2542002|NCT03014479|Secondary|Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at Each Assessment Time Point|DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.|Baseline (Week 0), up to Week 4, 12|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Units on a Scale||Standard Deviation|Mean
2542120|NCT03007966|Primary|Post-operative Verbal Pain Score With Movement|Assessed on an 11-point (0-10) numeric analog scale with a higher score denoting a worse outcome.|8 hrs Post Nerve Block||||score on a scale||Standard Deviation|Mean
2542121|NCT03007719|Secondary|Change Between Pre-treatment and Post-treatment SUVmax in Lymphoid Organs on Whole-body [18F]F-AraG PET/MR Imaging (Cohort 1 and 2)||Up to 8 days|SUVmax data not collected||||||
2542003|NCT03014479|Secondary|Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 4: Satisfaction With Treatment] at Each Assessment Time Point|DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.|Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Units on a Scale||Standard Deviation|Mean
2542004|NCT03014479|Secondary|Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 3: Hypoglycemia] at Each Assessment Time Point|DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.|Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Units on a Scale||Standard Deviation|Mean
2542005|NCT03014479|Secondary|Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 2: Anxiety and Dissatisfaction With Treatments] at Each Assessment Time Point|DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.|Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Units on a Scale||Standard Deviation|Mean
2542006|NCT03014479|Secondary|Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 1: Burden on Social Activities and Daily Activities] at Each Assessment Time Point|DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.|Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Units on a Scale||Standard Deviation|Mean
2542007|NCT03014479|Primary|Change From Baseline in Total Score for All Question Items in the Diabetes Therapy Related -QOL (DTR-QOL) Questionnaire at the End of Study|DTR-QOL Questionnaire is a self-reported instrument assessing impact of diabetes treatment on health-related QOL. It includes 29 items across 4 subscales; Factor 1: Burden on social activities and daily activities (13 questions), Factor 2: Anxiety and dissatisfaction with treatment (8 questions), Factor 3: Hypoglycemia (4 questions) and Factor 4: Treatment satisfaction (4 questions). Each item is scored ranging from 1 to 7. Every score of the questions in Factor 1-3 and the score in Factor 4 converted into reverse (1-7 will be converted to 7-1) will be simply added up, and scores of each factor and the total figure will be subsequently converted from 0 to 100 (the best and worst scores will be equivalent to 100 and 0). Higher scores reflect better QOL and positive changes relative to baseline indicate improvement of QOL.|Baseline (Week 0), up to the end of study (Week 12)|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||Units on a Scale||Standard Deviation|Mean
2542008|NCT03014453|Primary|the Late Complications of BPD Infants|In all patients, complications were evaluated via questionnaires at 3, 6, 9 and 12 months corrected for premature age, including respiratory symptoms (including home respiratory support, respiratory medication administration, cough without cold at least once per week, re-hospitalization due to respiratory diseases), vomiting when feeding, hypoxic ischemic injury, retinopathy of prematurity, rehospitalization and sudden death.|18 months||||Participants|||Count of Participants
2542351|NCT03001453|Primary|Patient Morphine Equivalent Consumption|All opioid doses were administered to the patient at 12-hour intervals post-surgery. Doses were recorded till either of the following criteria was met, the patient was discharged or the 72-hour post-surgery timeframe ended. The doses were then collected and converted to OMEs, in milligrams.|72 hours postoperation, divided into six 12-hour periods||||mg||Standard Deviation|Mean
2542009|NCT03014206|Primary|Number of Participants With Adverse Reactions|An adverse reaction (vaccine-related adverse event) was any untoward medical occurrence attributed to Prevenar 13 in a participant who received Prevenar 13. A serious adverse reaction was a vaccine-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Prevenar 13 was assessed by the physician.|28 days|The safety analysis set comprised of participants who satisfied the inclusion criteria and provided the safety data after vaccination with Prevenar 13.|||Participants|||Number
2542010|NCT03014180|Secondary|Safety of the LVAT Algorithm|Reporting of SAEs, device deficiencies and any suspect behaviour of the algorithm.|0-3 months post inclusion|Included population|||Event|||Number
2542011|NCT03014180|Secondary|Percentage of Eligible Subjects to LVAT Feature|"Identification of the number of subjects who were eligible to receive the feature at M0 or M1 visit"|0-3 months post inclusion|Eligible subjects: Number of subjects with at least one complete LV Vector Test at M0 or M1 visits|||Percentage of eligible subjects|||Number
2542012|NCT03014180|Secondary|"Percentage of Successful In-Clinic LVAT Test at M1 Visit"|"The success rate of In-Clinic LVAT feature for all available LV pacing vectors at second follow-up . The method of analysis is similar to the primary endpoint"|1-3 months after first visit|"Completed LV Vector Test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm.~Successful LV Vector Test: LV threshold value provided by the algorithm compared to the manual threshold is considered “Successful” if the difference is within ± 2 steps"|||Pecentage of successful LVAT test|Number of completed LV Vector Tests|95% Confidence Interval|Number
2542013|NCT03014180|Secondary|"Percentage of Successful of In-Clinic LVAT Test at M0 Visit"|"The success rate of In-Clinic LVAT feature for all available LV pacing vectors at first follow-up (M0 visit). The method of analysis is similar to the primary endpoint."|0-15 days post inclusion|"Completed LV vector Test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm.~Successful LV Vector Test: LV threshold value provided by the algorithm compared to the manual threshold is considered “Successful” if the difference is within ± 2 steps"|||Percentage of successful LVAT test|Number of completed LV Vector Tests|95% Confidence Interval|Number
2542014|NCT03014180|Secondary|"Percentage of Accurate In-Clinic LVAT Test Assessed by an Independent Reviewer"|"This endpoint is the number of accurate determination of the pacing threshold value provided by the algorithm feature and an independent reviewer, on all available LV pacing vectors at first visit.~An independent reviewer assessed all LV pacing threshold values provided by the algorithm at M0 visit and in all tested configurations"|0-15 days post inclusion|"Completed LV Vector Test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm.~Accurate LV Vector Test: The LV threshold value provided by the algorithm compared to the reviewer assessment is considered accurate if the difference is within ± 1 step."|||Percentage of accurate determination|Number of completed LV Vector Tests|95% Confidence Interval|Number
2542015|NCT03014180|Primary|"Percentage of SuccessfulIn-Clinic LVAT Test"|The success rate is defined as the equivalence between the value measured by the algorithm and the measure obtained manually by the physician on 5 identified pacing vectors during the visit among at least 231 LV tests.|0-3 months post inclusion|"Complete LV vector test: test was performed (not aborted or interrupted) and a threshold value is provided by the algorithm.~Successful LV Vector Test: LV threshold value provided by the algorithm compared to the manual threshold is considered “Successful” if the difference is within ± 2 step"|||percentage of successful LVAT test|Completed LV vector tests|95% Confidence Interval|Number
2542016|NCT03014011|Primary|Psychomotor Speed|"Symbol Digit Modalities Test was used as a measurement of psychomotor speed.~For the Symbol Digit Modalities Test, participants were required to use a coded key to match nine abstract symbols paired with numerical digits. The final score is the correct number of substitutions in 120 s, and scores range between 0 and 110. Higher values represent a better outcome."|All neurocognitive testing was assessed at each intervention when glucose levels had been stabile for 40 minutes, an average of 2 hours after clamp procedure start. The duration of neurocognitive testing was approximately 40 min.|The two interventions were hypoglycaemia (aiming for a plasma glucose target of 3.0 ± 0.2 mmol/l) and euglycaemia (plasma glucose clamp target 6.0 ± 0.2 mmol/l).|||score on a scale||Standard Deviation|Mean
2542017|NCT03012828|Other Pre-specified|Change From Baseline in Heart Rate (HR) and Duration of Other Interval Parameters (PR and QRS)|Changes from Baseline were assessed at each timepoint up to 72 hours post dose. Mean changes across the 72 hour assessment period for each parameter were calculated for each moxidectin group and the placebo group and for the population overall.|Baseline (pre-dose) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, and 72 hours post dosing|ECG population - all subjects who receive one dose of study drug and have at least one pair of pre-dose and post-dose QTc data, analyzed as randomized|||milliseconds||95% Confidence Interval|Mean
2542018|NCT03012828|Other Pre-specified|Subjects With Categorical Changes From Baseline in 12-lead Electrocardiograms (ECGs)|Changes from baseline in QTcF exceeding regulatory standard categorical limits (> 30msec change or exceeding 450msec). Report applies to changes of 30msec - </= 60msec only|At Baseline and Days 1, 2, 3, 4, 22 and Week 12|Safety population - all who received at least one dose of study drug|||participants|||Number
2542019|NCT03012828|Secondary|Concentrations of Moxidectin in Plasma|Concentrations of moxidectin in plasma were assessed by collection of plasma samples at pre-specified intervals after oral dosing with moxidectin. The concentration of moxidectin was determined using a validated LC MS/MS method.The pharmacokinetic time points coincided with ECG collection timepoints (within 5 minutes and no later than 10 minutes after ECG recordings). Plasma PK parameters were estimated from the concentration measurements, including maximum concentration (Cmax) for each individual and mean for each dose cohort.|Pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12*, 24, 36, 48, 60, and 72 hours and days 8,15 and 22 post dosing|Pharmacokinetic population - includes all subjects who received at least 1 dose of moxidectin and provide an adequate number of plasma samples for determination of PK parameters, analyzed according to drug received.|||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2542522|NCT02998996|Primary|Local Tolerability - First Dose|Local tolerability, as measured by at least one of the administration site reactions swelling, redness, pain and pruritus, regardless of severity.|Pre-dose, and 15 and 120 min after study drug administration (Visit 2).||||Participants|||Count of Participants
2542020|NCT03012828|Primary|Mean Change From Baseline in QTc Interval (Corrected by Friderica's Formula, dQTcF) Associated With Plasma Moxidectin Concentrations After a Single Dose|Triplicate 10-second ECG recordings taken 1 minute apart using a Mortara continuous 12-lead digital ECG recorder connected to each subject during the Baseline to 72-hour post dose confinement period. Baseline only and baseline and placebo adjusted changes in QTc interval (corrected using the Friderica formula, QTcF) at each timepoint for each dose level were determined. The mean change from baseline (without and with placebo correction, dQTcF and ddQTcF respectively) at each of the 14 time points was calculated for each dose level. The primary outcome measure was the mean dQTcF for all subjects(the dQTcF gradient). The mean dQTcF for each active treatment group was determined at each post dose timepoint but the mean dQTcF by dose level was not calculated. The mean dQTcF at approximate moxidectin Tmax (hour 3 or hour 4) for each active treatment group and at hour 3 for the placebo group is reported.|Baseline (pre-dose) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, and 72 hours post dosing|The ECG population included all subjects who received one dose of study drug and have at least 1 pair of pre-dose and post-dose QTc interval and was used in the model.|||millseconds||90% Confidence Interval|Mean
2542021|NCT03012334|Secondary|Driving Performance Using the CRCDS-MiniSim - Speed Deviation|The CRCDS-MiniSim is a PC-based research driving simulator that provides a realistic automotive driving environment. The present study employs the Country Vigilance-Divided Attention (CVDA) driving scenario, a 62.1 mile (100 km), monotonous, two lane highway driving task that includes a secondary visual vigilance task (DA). The monotonous Country Vigilance scenario has been demonstrated to be sensitive to detect the effects of fatigue or sleepiness on driving performance. Speed deviation is a measure of intra-individual variability. Measures that assess an individual's failure to maintain consistent performance are more sensitive to sedation than are measures of absolute performance.|Approximately 90 minutes post dose, on Day 1, 7, 14, 21, or 28 depending upon the assigned treatment sequence|All randomized participants who received study drug and have evaluable data for driving performance.|||meter per second (m/sec)||Standard Deviation|Mean
2542022|NCT03012334|Other Pre-specified|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.|Up To 35 days|All randomized participants who received study drug.|||Participants|||Count of Participants
2542023|NCT03012334|Secondary|Driving Performance Using the CRCDS-MiniSim - Lane Exceedance|The CRCDS-MiniSim is a PC-based research driving simulator that provides a realistic automotive driving environment. The present study employs the Country Vigilance-Divided Attention (CVDA) driving scenario, a 62.1 mile (100 km), monotonous, two lane highway driving task that includes a secondary visual vigilance task (DA). The monotonous Country Vigilance scenario has been demonstrated to be sensitive to detect the effects of fatigue or sleepiness on driving performance. Lane exceedance is the number of lane exceedances, an indication of lane position control, (i.e., the driver's ability to stay within his/her lane), as measured by the number of times that the front left or right tire of the vehicle crosses over the right or left lane boundary.|Approximately 90 minutes post dose, on Day 1, 7, 14, 21, or 28 depending upon the assigned treatment sequence|All randomized participants who received study drug and have evaluable data for driving performance.|||Lane Exceedances||Standard Deviation|Mean
2542024|NCT03012334|Secondary|Number of Correct Responses in Driving Performance Using CogScreen Symbol Digit Coding (SDC) Test|The SDC Test, a digit symbol substitution test that is sensitive to changes in information processing speed, provides measures of response speed and accuracy. The test was administered prior to the simulated driving sessions. The principal test score measures the number of correct responses in 120 seconds. SDC was used in this study to measure attention, visual scanning, working memory, and speed of information processing. Scores range from 0 (No correct responses). A higher score indicates greater processing speed.|Approximately 85 minutes post dose, on Day 1, 7, 14, 21, or 28 depending upon the assigned treatment sequence|All randomized participants who received study drug and have evaluable data for driving performance.|||Responses||Standard Deviation|Mean
2542025|NCT03012334|Secondary|Motivational and Self-Appraisal Visual Analog Scale (VAS)|After completing the driving simulation, participants assessed their own performance and their level of motivation to perform at their best during the driving simulation. Participants responded to 2 questions: 1. How well do you think you drove for the last 60 minutes? 2. How motivated did you feel to drive at your best during the last 60 minutes of driving?. Participants recorded their response to each question by writing a vertical line on a 100 millimeters (mm) horizontal, linear visual analog scale indicating their level of performance (Not Satisfactory to Satisfactory) and motivation (Not Motivated to Motivated). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. Scores ranged from 0-100 mm, with higher scores indicating motivated and satisfactory and lower scores indicating not motivated and not satisfactory.|Approximately 2.5 hours post dose, on Day 1, 7, 14, 21, or 28 depending upon the assigned treatment sequence|All randomized participants who received study drug and have evaluable data for visual analog scale.|||Millimeters (mm)||Standard Deviation|Mean
2542026|NCT03012334|Secondary|Percentage of Participants With Self-Reported Readiness to Drive|"On each dosing day participants were asked Right now do you feel safe to drive?. Pair-wise comparisons for readiness to drive were analyzed using McNemar test."|Approximately 85 minutes post dose, on Day 1, 7, 14, 21, or 28 depending upon the assigned treatment sequence|All randomized participants who received study drug and have evaluable data for self-reported readiness to drive.|||Percentage of Participants|||Number
2542027|NCT03012334|Secondary|Karolinska Sleepiness Scale (KSS) Score|The KSS is used to assess subjective level of sleepiness. This is a participant self-report measure of situational sleepiness and provides an assessment of alertness/sleepiness at a particular point in time. It is a 9-point categorical Likert scale on which the participant rates sleepiness from 1 (very alert) to 9 (very sleepy/fighting sleep), with higher scores indicating more sleepiness and lower scores indicating more alertness.|Approximately 85 minutes post dose, on Day 1, 7, 14, 21, or 28 depending upon the assigned treatment sequence|All randomized participants who received study drug and have evaluable data for karolinska sleepiness scale.|||Units on a scale||Standard Deviation|Mean
2542908|NCT02989727|Primary|Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)|Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.|Six weeks||||Participants|||Count of Participants
2542028|NCT03012334|Primary|Simulated Driving Performance in Healthy Participants as Measured by Standard Deviation of Lateral Position (SDLP) Using the Cognitive Research Corporation Driving Simulator-MiniSim (CRCDS-MiniSim)|The standard deviation of lateral position (SDLP) is the primary parameter used as stable measure of driving performance with high test-retest reliability. It measures the driver's ability to stay in a constant position within the driving lane. Variations in the lateral position are recorded and analyzed. SDLP, was analyzed using a mixed model with fixed effects for sequence, period, and treatment, and a random effect for participant within sequence. A variance component covariance structure and Kenward-Roger degrees of freedom was used.|Approximately 90 minutes post dose, on Day 1, 7, 14, 21, or 28 depending upon the assigned treatment sequence|All randomized participants who received study drug and have evaluable data for simulated driving performance.|||Centimeters (cm)||Standard Deviation|Mean
2542029|NCT03012191|Secondary|Improved EBDASI Scores|EBDASI - Epidermolysis Bullosa Disease Activity and Scarring Index Scale - Minimum (0) to Maximum (506) A lower score indicates a better outcome (less disease activity and/or damage) A clinical tool for evaluating the disease activity and damage associated with bullous patients. To be administered by a licensed dermatologist.|6 months|EBDASI is a system-wide disease activity score used for participants in the Intravenous Gentamicin phase of the study. Participants receiving Topical and Intradermal Gentamicin were not administered the EBDASI.|||Scores on a scale||Full Range|Mean
2542030|NCT03012191|Primary|Number of Participants With Absence of Gentamicin Side Effects Especially the Detection of Any Ototoxicity or Nephrotoxicity|Prolonged exposure to systemic gentamicin is associated with ototoxicity and nephrotoxicity. Specific tests (creatinine clearance and gold-tone audiometry) are performed throughout the study in order to detect any drug-specific adverse events as a result of systemic exposure to gentamicin. Additionally, we test patient skin and serum throughout the study to look for increase of autoantibodies to C7. Since some of these patients may have never had C7 expressed in their bodies, gentamicin-induced C7 may cause in auto-immune response.|6 months||||Participants|||Count of Participants
2542031|NCT03012191|Primary|Number of Participants With New or Increased Numbers of Anchoring Fibrils as Assessed by Immuno-electron Microscopy|The expression of anchoring fibril structures at the patients' dermal-epidermal junction was assessed by immuno-electron microscopy (IEM) using an antibody specific to type VII collagen. The IEM expression of anchoring fibrils was assessed before treatment and at one and three months after treatment. At each assessment time point, anchoring fibrils were compared with normal human skin. Baseline pre-treatment and one and three month post-treatment sites were compared for the presence of anchoring fibrils after gentamicin treatment (or increase if anchoring fibrils were detected at baseline in patients).|6 months||||Participants|||Count of Participants
2542032|NCT03012191|Primary|Increased Expression of Full-length Type VII Collagen as Assessed by Immunofluorescence|The expression of type VII collagen at the patients' dermal-epidermal junction was assessed by immunofluorescence (IF) using an antibody specific to type VII collagen. The expression was semi-quantitated using NIH Image J software. The IF expression of type VII collagen was assessed before treatment and at one and three months after treatment. At each assessment time point, type VII collagen expression was also measured in normal human skin. The expression of type VII collagen was then expressed as a percentage of the type VII collagen expressed in normal human skin.|6 months||||C7 Expression (percent of normal skin)||Full Range|Mean
2542033|NCT03012061|Secondary|Mean Change From Baseline in On-treatment Pulse Rate|Pulse rate was measured at every clinic visit, starting at Visit 1, and prior to conducting spirometry. Pulse rate was measured with participant in sitting position after approximately 5 minutes rest. Baseline value was defined as the latest vital signs assessment prior to randomized treatment start, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the value at specified time point. LS mean and SE data is presented.|Baseline (Day 1 pre-dose), Weeks 4, 12 and 24|Intent-to-Treat Population. Participants with available data at Baseline and at least one time point post-Baseline were analyzed. Participants with data available at the specified time points are represented by (n=X) in the category titles.|||Beats per minute||Standard Error|Least Squares Mean
2542034|NCT03012061|Secondary|Mean Change From Baseline in On-treatment Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure was measured at every clinic visit, starting at Visit 1, and prior to conducting spirometry. Blood pressure was measured with participant in sitting position after approximately 5 minutes rest. Baseline value was defined as the latest vital signs assessment prior to randomized treatment start, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the value at specified time point. LS mean and SE data is presented. Different participants may have data available at different time points; thus, the overall number of participants analyzed reflects everyone in the ITT Population without missing covariate information and with a Baseline and at least one post-Baseline measurement.|Baseline (Day 1 pre-dose), Weeks 4, 12 and 24|Intent-to-Treat Population. Participants with available data at Baseline and at least one time point post-Baseline were analyzed. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Millimeters of mercury||Standard Error|Least Squares Mean
2542035|NCT03012061|Secondary|Number of Participants With On-treatment Abnormal Electrocardiograms (ECG) Findings|A single 12-lead ECG and rhythm strip was recorded after measurement of vital signs and spirometry at given time points. All ECG measurements were measured with participants in supine position after >=5 minutes rest. All ECGs were electronically transmitted to an independent and treatment-blinded cardiologist for the measurement. ECG was obtained 15 minutes to 45 minutes after the administration of study treatment. Data for number of participants with abnormal ECG Findings have been reported.|Week 4 and Week 24|Intent-to-Treat Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2542047|NCT03011099|Primary|Change in Muscle Activity as Assessed by Surface Electromyography (EMG)|Surface EMG sensors will be placed on the skin of subjects' lower extremities and trunk to measure muscle activity. Only one participant data was analyzed. Emg was recorded from the soleus, gastrocnemius, tibialis anterior, rectus femoris, vastus medialis, bicep femoris and semitendinosus muscles. The outcome measure is the %age change between the baseline and 4 week assessments. Negative values denotes decrease in muscle activity at 4 week compared to baseline.|baseline, week 4|This measure was later added to the protocol and hence data was collected from one participant only.|||percentage of muscle activity change|||Number
2542036|NCT03012061|Secondary|Number of Participants With On-treatment Adverse Events (AE), Non-serious Adverse Events (Non-SAE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with on-treatment AEs and SAEs and serious adverse events (SAE) and common (>=3%)non-SAEs have been reported.|Up to Week 24|Intent-to-Treat Population|||Participants|||Count of Participants
2542037|NCT03012061|Secondary|Mean Change From Baseline in Clinic FEV1 at 3 Hours Post Dose at Week 24|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The highest of 3 technically acceptable measurements were recorded at each Visit. The Baseline value of clinic FEV1 was the last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomization (either from Visit 2 pre-dose or from Visit 1 pre-bronchodilator). Change from Baseline was calculated as FEV1 value at Week 24 (recorded at 3 hours post dose) minus FEV1 value at Baseline. The analysis only including data collected on-treatment. LS mean change and SE data is presented.|Baseline (Day 1 pre-dose) and Week 24|Intent-to-Treat Population. Only those participants with available on-treatment data at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2542038|NCT03012061|Primary|Mean Change From Baseline in Clinic Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24|FEV1 is measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The highest of 3 technically acceptable measurements were recorded at each Visit. The Baseline value of clinic FEV1 was last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomized treatment start date. Change from Baseline was calculated as FEV1 value at Week 24 minus FEV1 value at Baseline. Treatment policy estimand was assessed, including all on- and post-treatment data. Intent-to-Treat Population comprised all randomized participants, excluding those who were randomized in error, who did not receive the study drug. Least square (LS) mean and standard error (SE) data is presented. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline, at least one post-Baseline measurement.|Baseline (Day 1 pre-dose) and Week 24|Intent-to-Treat Population. Participants with available data at Baseline and at least one time point post-Baseline were analyzed. All on- and post-treatment data was included. Different participants may have been analyzed at different time points.|||Liters||Standard Error|Least Squares Mean
2542039|NCT03011840|Secondary|Satisfaction About Information With Respect to Instructions to be Followed|Patients satisfaction with respect to instruction to be followed with administration of GA will be captured on a five point Likert scale -(5-Excellent, 4-Very good, 3-Good, 2-Poor, 1-Very poor)|On scheduled minor operative procedure day||||Participants|||Count of Participants
2542040|NCT03011840|Primary|Number of Cases Postponed Due to Lack of Information to Patients in the Pre-operative Period|Cases postponed will be recorded and those caused due to lack of information of basic instruction to be followed prior to a procedure under GA will be recorded as an event.|On scheduled minor operative procedure day|Number participants analysed depends upon the number of patients visited to the minor ot complex during assigned time period.|||Participants|||Count of Participants
2542041|NCT03011099|Secondary|Exoskeleton User Feedback as Assessed by a Questionnaire|A questionnaire will be administered to allow participants to provide feedback regarding their experiences during training sessions with the exoskeleton. The units on a scale was used to measure the feedback. The range of the scale was 1-5. '1' refers to very satisfied and '5' refers to very dissatisfied. '1' refers to a better outcome.|week 4|This measure was only recorded from the participants in the robotic exoskeleton training group. This outcome was mainly related to the feedback of the participants after using the exoskeleton at the end of the training.|||units on a scale||Standard Deviation|Mean
2542042|NCT03011099|Secondary|Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS)|"The ASIA (American Spinal Injury Association) assessment protocol consists of two sensory examinations, a motor examination and a classification framework (the impairment scale) to quantify the severity of the spinal cord injury. The scale informs about the functionality of the patient. The range of scores is 0 to 5, and high values represent better outcome. Following is the description of the range:~0 = total paralysis~= palpable or visible contraction~= active movement, full range of motion (ROM) with gravity eliminated~= active movement, full ROM against gravity~= active movement, full ROM against gravity and moderate resistance in a muscle specific position~= (normal) active movement, full ROM against gravity and full resistance in a functional muscle position expected from an otherwise unimpaired person~We report the difference between baseline and 4week assessments. Negative value denotes decrease at post assessment."|baseline, week 4||||units on a scale||Standard Deviation|Mean
2542043|NCT03011099|Secondary|Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time)|Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The outcome measure is the difference in step time between pre and post assessment. Negative value denotes decrease in step time (implying faster step time at post).|baseline, week 4||||seconds||Standard Deviation|Mean
2542044|NCT03011099|Secondary|Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length)|Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The change in step length between baseline and post assessment is reported. Negative value denotes decrease in step length.|baseline, week 4||||cm||Standard Deviation|Mean
2542045|NCT03011099|Secondary|Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence)|Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. Cadence is measured as steps/min. Change in cadence is reported as difference between baseline and post assessment.|baseline, week 4||||steps/min||Standard Deviation|Mean
2542048|NCT03011099|Primary|Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test|The Timed Up and Go test assessed the time it takes to stand from a sitting position, complete a 3 meter walk, and then return to sitting.|baseline, week 4||||Second||Standard Deviation|Mean
2542051|NCT03011034|Secondary|Time to Progression to Acute Myeloid Leukemia (AML)|"Time to progression to acute myeloid leukemia was reported. Disease progression as per IWG response criteria: For participants with:~<5% blasts: >=50% increase in blasts to >5% blasts; 5%-10% blasts: >=50% increase to >10% blasts; 10%-20% blasts: >=50% increase to >20% blasts; 20%-30% blasts: >=50% increase to >30% blasts. Any of the following: >=50% decrement from maximum remission/response in granulocytes or platelets; reduction in hemoglobin by >=2 g/dL; transfusion dependence."|Up to 2 years|ITT population included all participants who received at least 1 dose of study drug.|||Weeks||95% Confidence Interval|Median
2542052|NCT03011034|Secondary|Overall Survival|The overall survival was defined as the time from the date of first dose of study drug to date of death from any cause. Median overall survival was estimated by using the Kaplan-Meier method.|Up to 2 years|ITT population included all participants who received at least 1 dose of study drug.|||Months||95% Confidence Interval|Median
2542053|NCT03011034|Secondary|Percentage of Participants With Cytogenetic Response|Percentage of participants with cytogenetic response were reported. Cytogenetic response per International Working Group (IWG) 2006 Response criteria: Complete - disappearance of the chromosomal abnormality without appearance of new ones; Partial - at least 50% reduction of the chromosomal abnormality.|Up to 2 years|ITT population included all participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2542054|NCT03011034|Secondary|Percentage of Participants With Partial Remission (PR)|Percentage of participants with PR were reported. PR per International Working Group (IWG) 2006 Response criteria: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by >=50% over pretreatment but still >5%, cellularity and morphology not relevant.|Up to 2 years|ITT population included all participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2542055|NCT03011034|Secondary|Percentage of Participants With Complete Remission (CR) and Marrow CR|Percentage of participants with CR and marrow CR were reported. CR per International Working Group (IWG) 2006 Response criteria: Bone marrow - less than or equal to (<=)5% myeloblasts with normal maturation of all cell lines, persistent dysplasia noted; Peripheral blood - hemoglobin >=11 g/dL; platelets >=100*10^9/L; neutrophils >=1.0*10^9/L; blasts, 0%. Marrow CR: Bone marrow - <=5% myeloblasts and decrease by >=50% over pretreatment; Peripheral blood - if HI responses, they were noted in addition to marrow CR.|Up to 2 years|ITT population included all participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2542056|NCT03011034|Secondary|Percentage of Participants With Hematologic Improvement (HI) Per IWG 2006 by Investigator Assessment|Percentage of participants with HI per International Working Group (IWG) 2006 by investigator assessment were reported. Response criteria per IWG 2006 for HI: Erythroid response (pretreatment, less than [<]11 gram per deciliter [g/dL]) - hemoglobin increase by greater than or equal to (>=)1.5 g/dL, relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks. Only RBC transfusions given for a Hb of <=9 g/dL pretreatment counted in the RBC transfusion response evaluation; Platelet response (pretreatment, <100*10^9/L) - absolute increase of >=30*10^9/L for participants starting with >20*10^9/L platelets. Increase from <20*10^9/L to >20*10^9/L and by at least 100 percent (%); Neutrophil response (pretreatment, <1*10^9/L) - at least 100% increase and an absolute increase >0.5*10^9/L.|Up to 2 years|ITT population included all participants who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2542057|NCT03011034|Secondary|Percentage of Participants With at Least One Dose of Myeloid Growth Factors Usage|Percentage of participants with Myeloid Growth Factors (MGF) usage (who had used at least 1 dose of MGF) were reported.|Up to 2 years|ITT population included all participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2542058|NCT03011034|Secondary|Percentage of Participants Who Met IWG Criteria for Transfusion Reduction|Percentage of participants who met IWG criteria for transfusion reduction were reported. IWG criteria for transfusion reduction: at least 4 units reduction in RBC transfusions in the best 8-week interval. The best 8-week interval was a post-baseline 8-week interval where the participant had the fewest post-baseline RBC transfusion units.|Up to 2 years|ITT population included all participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2542059|NCT03011034|Secondary|Duration of Transfusion Independence (TI)|Duration of TI was reported. TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization.|Up to 2 years|ITT population who achieved TI for at least 8 weeks. As less number of participants were evaluable for this outcome measure (OM), the results were not summarized. Hence, participant wise data is reported.|||Weeks|||Number
2542060|NCT03011034|Secondary|Time to Transfusion Independence (TI)|Time to transfusion independence (TI) was defined as time to the start of the TI interval. TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization.|Up to 2 years|ITT population who achieved TI for at least 8 weeks. As less number of participants were evaluable for this outcome measure (OM), the results were not summarized. Hence, participant wise data is reported.|||Weeks|||Number
2542061|NCT03011034|Secondary|Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) Lasting at Least 24 Weeks|Percentage of participants who achieved RBC TI lasting at least 24 weeks were reported. RBC TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization.|Up to 2 years|ITT population included all participants who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2542062|NCT03011034|Primary|Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) Lasting at Least 8 Weeks|Percentage of participants who achieved RBC TI lasting at least 8 weeks were reported. RBC TI was defined as absence of RBC transfusion during any consecutive 56 days (8 weeks) post randomization.|Up to 2 years|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2542063|NCT03010800|Primary|Pad Weight Difference|Comparison of urine weight of the pad without Yoni,Fit to the weight of the pad with Yoni.Fit controlling for the tare weight.|An hour after finishing a liter of liquid||||grams|||Number
2542686|NCT02994732|Primary|Pharmacokinetics of 14C-labeled BVD-523(Radioactivity in Whole Blood and Plasma) Tmax|Time to peak concentration (Tmax), PK blood samples were taken at the following time points 0 (predose), 30 min, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dose.|Collected over 5 days|All enrolled subjects|||hr||Standard Deviation|Median
2542064|NCT03010631|Other Pre-specified|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is any untoward medical occurrence that results in death;is life-threatening;requires inpatient hospitalization or prolongation of present hospitalization;results in persistent or significant disability/incapacity;is a congenital anomaly/birth defect;or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent.|From the first dose of study drug up to 28 days|Safety Population.|||Participants|||Count of Participants
2542065|NCT03010631|Secondary|Cohort 2: Maximum Observed Concentration (Cmax) of M3 Metabolite in Fed vs Fasted Conditions||1 day|PK Evaluable Population.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2542066|NCT03010631|Secondary|Cohort 2: Total Exposure (AUC0-t) of M3 With Administration of Sprinkle Lubiprostone Under Fed Versus (vs) Fasted Condition||1 day|PK Evaluable Population.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Least Squares Mean
2542067|NCT03010631|Primary|Cohort 1: Maximum Observed Concentration (Cmax) of M3 Metabolite||1 day|Evaluable PK Population included all participants in the PK Population who had sufficient plasma drug concentration data of either lubiprostone or M3 to calculate at least 1 evaluable PK parameter.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2542068|NCT03010631|Primary|Cohort 1: Area Under the Concentration-time Curve (AUC) From Hour 0 to the Last Measurable Concentration (AUC0-t) of M3 Metabolite||1 day|PK population, defined as those with plasma concentration of lubiprostone or M3 sufficient to calculate at least 1 PK parameter|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2542069|NCT03010501|Secondary|Differences in Food and Beverage Intake by Energy Density|Differences in daily intake of food and beverages by energy density, in kcal/g|Days 1-5 in weeks 1, 2, and 3|Data of 1 enrolled participant was excluded from analysis for absence from meals on 3 or more days in multiple intervention periods.|||kilocalories/gram||Standard Error|Mean
2542070|NCT03010501|Primary|Differences in Food and Beverage Intake by Weight|Differences in daily intake of food and beverages by weight, in grams|Days 1-5 in weeks 1, 2, and 3|Data of 1 enrolled participant was excluded from analysis for absence from meals on 3 or more days in multiple intervention periods.|||grams||Standard Error|Mean
2542071|NCT03010501|Primary|Differences in Food and Beverage Intake by Energy|Differences in daily intake of food and beverages by energy, in kcal|Days 1-5 in Weeks 1, 2, and 3|Data of 1 enrolled participant was excluded from analysis for absence from meals on 3 or more days in multiple intervention periods.|||kilocalories||Standard Error|Mean
2542072|NCT03010254|Secondary|"Percentage of Subjects Who Respond Never to Question 3 of the Spectacle Use Questionnaire: How Often Do You Wear Eyeglasses for Intermediate Tasks (e.g., Computer)?"|No formal statistical hypothesis testing was planned.|Month 6 (120-180 days post second eye implantation)|All-Implanted Analysis Set|||percentage of subjects|||Number
2542073|NCT03010254|Secondary|"Percentage of Subjects Who Respond Never to Question 1 of the Spectacle Use Questionnaire: How Often Do You Wear Eyeglasses for Any Purpose?"|Proportion of subjects was reported as a percentage. No formal statistical hypothesis testing was planned.|Month 6 (120-180 days post second eye implantation)|All-Implanted Analysis Set|||percentage of subjects|||Number
2542074|NCT03010254|Secondary|Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd)|Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed monocularly with the subject's best spectacle correction under mesopic (low, but not quite dark) conditions at a distance of 8 feet (2.45 m) from the eye at a spatial frequency of 12 cpd using the Vector Vision CSV 1000-HGT with and without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. A higher numeric value represented better contrast sensitivity. This analysis was prespecified for the first operative eye.|Month 6 (120-180 days post second eye implantation)|All-Implanted Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at without glare and with glare assessments.|||log unit|Eyes|Standard Error|Least Squares Mean
2542075|NCT03010254|Secondary|Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve|Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction, added defocus and 100% contrast ETDRS charts. VA was measured between +1.50 Diopter (D) and -2.50 D in 0.5 D defocus steps, except in the region from +0.50 D through -0.50 D, which was assessed in 0.25 D steps. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified for the first operative eye. No formal statistical hypothesis testing was planned.|Month 3 (70-100 days post second eye implantation)|This analysis population included all eyes successfully implanted that had at least 1 postoperative visit, no macular degeneration at any time, and no major protocol violations (Best-case Analysis Set). Number analyzed is the number of subjects/eyes with data available for analysis at specified defocus.|||diopter|Eyes||Number
2542076|NCT03010254|Secondary|Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm|VA was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.|Month 3 (70-100 days post second eye implantation)|All-Implanted Analysis Set|||logMAR|Eyes|Standard Error|Least Squares Mean
2542198|NCT03004846|Primary|Change From Baseline in Hemoglobin Levels: Part A|Blood samples were collected from participants to evaluate clinical hematology parameters including hemoglobin. Change from Baseline in clinical hematology parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.|Baseline and up to Day 57|Safety analysis Population|||g/L||Standard Deviation|Mean
2542077|NCT03010254|Secondary|Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m)|VA was tested monocularly under photopic conditions using the correction obtained from the manual manifest refraction and 100% contrast, ETDRS charts at a distance of 4 m from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.|Month 3 (70-100 days post second eye implantation)|All-Implanted Analysis Set|||logMAR|Eyes|Standard Error|Least Squares Mean
2542078|NCT03010254|Primary|Percentage of Subjects With Ocular Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular AEs are events localized to the eye. Cumulative and persistent serious adverse events as defined by ISO 11979-7:2014 were collected for Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.|Day 0 (first operative eye visit) up to Month 6 (120-180 days post second eye implantation)|This analysis population included all eyes with attempted IOL implantation (successful or aborted after contact with the eye) (Safety Analysis Set). This outcome measure was pre-specified for the ACRYSOF® IQ Extended Depth of Focus IOL DTF015 only.|||percentage of subjects|Eyes||Number
2542079|NCT03010254|Primary|Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm)|Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.|Month 3 (70-100 days post second eye implantation)|All-Implanted Analysis Set|||logMAR|Eyes|Standard Error|Least Squares Mean
2542080|NCT03009162|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Safety was assessed from time of consent through end of study (up to 7 days). Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record.|Up To 7 days|All enrolled participants who received at least one dose of study drug.|||Participants|||Count of Participants
2542081|NCT03009162|Primary|Pharmacokinetics: Renal Clearance (CLr)|Renal Clearance is the volume of blood or plasma that is completely cleared of the drug by the kidneys per unit time. (Ae(0-t)/AUC0-T)|Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose|All enrolled participants who received at least one dose of study drug and have evaluable PK data.|||Liters/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2542082|NCT03009162|Primary|Pharmacokinetics: Fraction of Dose Excreted in Urine (fe)|Fraction of dose excreted in urine (Ae / dose)|Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose|All enrolled participants who received at least one dose of study drug and have evaluable PK data.|||Percentage||Geometric Coefficient of Variation|Geometric Mean
2542083|NCT03009162|Primary|Pharmacokinetics: Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae [0-t])|Amount excreted in urine (calculated as total lasmiditan concentration multiplied by volume of urine)|Predose and intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 36 hours, postdose|All enrolled participants who received at least one dose of study drug and have evaluable PK data.|||milligrams (mg)||Geometric Coefficient of Variation|Geometric Mean
2542084|NCT03009162|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf])|Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity (AUC[0-inf]) of lasmiditan.|Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours, postdose|All enrolled participants who received at least one dose of study drug and have evaluable PK data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2542085|NCT03009162|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Tlast (AUC[0-tlast])|Area Under the Concentration Versus Time Curve (AUC) from time zero to tlast (AUC[0- tlast]) of lasmiditan.|Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours, postdose|All enrolled participants who received at least one dose of study drug and have evaluable PK data.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2542086|NCT03009162|Primary|Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax)|Time of maximum observed plasma concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value|Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours, postdose|All enrolled participants who received at least one dose of study drug and have evaluable PK data.|||hours (h)||Full Range|Median
2542087|NCT03009162|Primary|Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)|Maximum observed plasma concentration of lasmiditan.|Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 36 hours, postdose|All enrolled participants who received at least one dose of study drug and have evaluable pharmacokinetics (PK) data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2542088|NCT03008707|Secondary|Incisional Hernia Rate||6 months|In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection|||Participants|||Count of Participants
2542089|NCT03008707|Secondary|Recurrent Colonic Diverticulitis Rate||6 months|In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection|||Participants|||Count of Participants
2542090|NCT03008707|Secondary|Average Length of Postoperative Hospital Stay||30 day|In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection|||days||Standard Deviation|Mean
2542091|NCT03008707|Secondary|Mean Postoperative Time||1 day|In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection|||minutes||Standard Deviation|Mean
2542092|NCT03008707|Primary|Post-operative Re-interventions Rate||15 days|In Laparoscopic Peritoneal Lavage, 1 patient out of 28 was excluded because of conversion to open surgery and resection|||Participants|||Count of Participants
2542096|NCT03008213|Primary|Number of Participants Completed All Study Procedures Over Seven Days|"The proposed study is a prospective, single-center, feasibility trial. The primary aim of this study is feasibility - specifically feasibility will be defined as completion of all study procedures over seven days.~For the primary aim, we assume an acceptable completion rate from strata of MEC/HEC or tumor types of all study-related procedures would be at least 70%. Assuming a true completion rate of 85%, a sample size of 50 patients would have an 80% power to detect an absolute difference of 15% at Type I error 0.05."|Through study completion, 7 days||||participants|||Number
2542097|NCT03008174|Secondary|Hospital Length of Stay|Hospital length of stay will be reported in days.|At the time of discharge, up to 4 months||||Days||Standard Deviation|Mean
2542098|NCT03008174|Secondary|Intensive Care Unit (ICU) Length of Stay|ICU length of stay will be reported in days.|At the time of discharge, up to 4 months||||Days||Standard Deviation|Mean
2542099|NCT03008174|Secondary|Number of Participants With Bleeding|Bleeding will be reported as present or absent.|At the time of use of speaking valve between 61 hours and 21 days after percutaneous tracheostomy procedure|Data for this outcome measure was only obtained from participants that completed the study.|||Participants|||Count of Participants
2542100|NCT03008174|Secondary|Number of Participants With Bleeding|Bleeding will be reported as present or absent.|At the time of use of speaking valve between 25 and 60 hours after percutaneous tracheostomy procedure||||Participants|||Count of Participants
2542101|NCT03008174|Secondary|Number of Participants With Bleeding|Bleeding will be reported as present or absent.|At the time of use of speaking valve up to 24hours after percutaneous tracheostomy procedure||||Participants|||Count of Participants
2542102|NCT03008174|Secondary|Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores|Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.|Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)|Data for this outcome measure was only obtained from participants that completed the study.|||score on a scale||Standard Deviation|Mean
2542103|NCT03008174|Secondary|Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores|Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.|Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)||||score on a scale||Standard Deviation|Mean
2542104|NCT03008174|Secondary|Quality of Life as Assessed by Quality of Life in Mechanically Ventilated Patients Scores|Quality of life as assessed by Quality of Life in Mechanically Ventilated Patients Scores. QOL scores will be reported on a scale of 0 - 100. The lower the score, the poorer the quality of life is, and the higher the score, the better the quality of life.|Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)||||score on a scale||Standard Deviation|Mean
2542105|NCT03008174|Primary|Speech Intelligibility as Assessed by Speech Intelligibility Test Score|Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).|Between 61 hours and 21 days after percutaneous tracheostomy procedure (assessed once within the period)|Data for this outcome measure was only obtained from participants that completed the study.|||Percentage of intelligible words||Standard Deviation|Mean
2542106|NCT03008174|Primary|Speech Intelligibility as Assessed by Speech Intelligibility Test Score|Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).|Between 25 and 60 hours after percutaneous tracheostomy procedure (assessed once within the period)||||Percentage of intelligible words||Standard Deviation|Mean
2542107|NCT03008174|Primary|Speech Intelligibility as Assessed by Speech Intelligibility Test Score|Speech intelligibility test scores will be reported in percentages (Percentage of words that were intelligible).|Up to 24 hours after percutaneous tracheostomy procedure (assessed once within the period)||||Percentage of intelligible words||Standard Deviation|Mean
2542108|NCT03007966|Secondary|Number of Participants With Presence of Opioid Related Side Effects--Vomiting||24 hrs Post Nerve Block|One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.|||Participants|||Count of Participants
2542109|NCT03007966|Secondary|Number of Participants With Presence of Opioid Related Side Effects--Nausea||24 hrs Post Nerve Block|One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.|||Participants|||Count of Participants
2542110|NCT03007966|Secondary|Number of Participants With Presence of Opioid Related Side Effects--Vomiting||8 hrs Post Nerve Block||||Participants|||Count of Participants
2542111|NCT03007966|Secondary|Number of Participants With Presence of Opioid Related Side Effects--Itching||8 hrs Post Nerve Block||||Participants|||Count of Participants
2542112|NCT03007966|Secondary|Number of Participants With Presence of Opioid Related Side Effects--Itching||24 hrs Post Nerve Block|One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.|||Participants|||Count of Participants
2542113|NCT03007966|Secondary|Number of Participants With Presence of Opioid Related Side Effects--Nausea||8 hrs Post Nerve Block||||Participants|||Count of Participants
2542114|NCT03007966|Secondary|Total Opioid Consumption|Total opioids consumed during the first 24hrs post operatively. Measured as 24hr Oxycodone Equivalent|24 hrs Post Nerve Block|One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.|||milligrams||Standard Deviation|Mean
2542115|NCT03007966|Secondary|Time to Onset of Post Operative Pain|When does the patient first note post operative pain?|24hrs Post Nerve Block|Data not collected||||||
2542116|NCT03007966|Secondary|Time to First Oral Analgesic|When does the patient require their first post operative analgesic dose?|24hrs Post Nerve Block|One patient was lost to follow up in the Ilioinguinal Block arm after the 8 hour post block time point which is why the patient flow number for that arm differs from the 24 hour time frame.|||minutes||95% Confidence Interval|Median
2542122|NCT03007719|Secondary|Compare Change in SUVmax of the Primary Tumor in Patients Who Achieve Pathologic Downstaging or Clinical Response and Those Without Pathologic or Clinical Response at Time of Surgery in Patients Receiving Neoadjuvant Atezolizumab (Cohort 1)|To correlate change in SUVmax to clinical and/or pathologic response, patients will be divided into two groups: those who achieved clinical response and/or pathologic downs-staging, and those who did not. The median and interquartile range of change in SUVmax from baseline to pre-surgery in the different groups will be descriptively reported. For Cohort 1, clinical response will be determined by abdominal imaging performed <30 days after the last dose of atezolizumab prior to cystectomy compared to baseline pre-treatment imaging using RECIST v1.1 criteria, as specified in the companion treatment protocol. For Cohort 1, pathologic response will be determined by evidence of down-staging (e.g. from muscle invasive to non-muscle invasive, or complete pathologic response) at the time of cystectomy.|Up to 6 weeks|SUVmax data not collected||||||
2542123|NCT03007719|Primary|Change Between Pre-treatment and Post-treatment SUVmax (Standardized Uptake Values) in the Primary and/or Metastatic Tumor(s) on Whole-body [18F]F-AraG Positron Emission Tomography/Magnetic Resonance (PET/MR) Imaging by Study Cohort.|The nonparametric paired Wilcoxon Signed-rank test will be used to assess differences in SUVmax before and after treatment. The log2 ratio of post-treatment versus baseline SUVmax within the tumor and lymphoid tissues will also be calculated|Up to 2 weeks|SUVmax data not collected||||||
2542124|NCT03006562|Secondary|Surveillance Bias by Differential Use of Imaging as Assessed by Number of Participants Receiving Postoperative Diagnostic Imaging for Venous Thromboembolism Relative to Symptoms|Patients in each arm receiving postoperative diagnostic imaging for venous thromboembolism relative to symptoms (e.g. lower extremity Duplex ultrasound, spiral CT angiography, V/Q scan).|30 days|One participant in the control arm was lost to follow-up precluding outcome assessment.|||Participants|||Count of Participants
2542125|NCT03006562|Secondary|Surgical Drain Output After Surgery|The total output in milliliters from any surgical drain left in place (not all patients will necessarily have a surgical drain) after surgery and until discharge from the hospital (usually 1 to 2 days). Drain output, if one is left in place after discharge, will not count toward this secondary outcome.|Over length of stay in hospital (usually 1 to 2 days)||||milliliters||Inter-Quartile Range|Median
2542126|NCT03006562|Secondary|Estimated Blood Loss During Surgery|The total recorded intraoperative estimated blood loss in milliliters reported at the end of the surgery.|During surgery (usually between 2-3 hours of operative time)||||milliliters||Inter-Quartile Range|Median
2542127|NCT03006562|Secondary|Number of Participants With Occurrence of Any Venous Thromboembolism|DVT or PE diagnosed for any reason within 30 days after surgery. This includes any diagnosed DVT or PE as described in the primary outcome plus any additional DVTs or PEs diagnosed at 30 day screening lower extremity ultrasound for patients opting to undergo screening bilateral lower extremity Duplex ultrasound at 30 days who do not have symptoms.|30 days|Only the subset receiving ultrasound are analyzed for this outcome.|||Participants|||Count of Participants
2542128|NCT03006562|Primary|Number of Participants With Major Postoperative Bleeding|This additional primary outcome includes the development and diagnosis of any major clinically recognized bleeding event within 30 days after surgery requiring >1 unit of packed red blood cell transfusion, intervention to stop bleeding, or return to the operating room.|30 days|One participant in the control arm was lost to follow-up precluding outcome assessment.|||Participants|||Count of Participants
2542129|NCT03006562|Primary|Number of Participants With Symptomatic Postoperative Fluid Collection|This outcome is defined as a surgical or pelvic fluid collection diagnosed as a hematoma (blood collection, with or without infection) or lymphocele (collection of lymph fluid in the pelvis) due to symptoms (fever, abdominal pain, nausea or vomiting, anemia, high surgical drain output) within 30 days after surgery.|30 days|One participant in the control arm was lost to follow-up precluding outcome assessment.|||Participants|||Count of Participants
2542130|NCT03006562|Primary|Number of Participants With Symptomatic Venous Thromboembolism|Venous thromboembolism (VTE) is a disease that includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). The primary outcome is diagnosis of DVT or PE within 30 days after surgery due to imaging (any method, most commonly lower extremity ultrasound or computed tomography scan with pulmonary embolus protocol) prompted by symptoms of a DVT (lower extremity swelling, pain, fever of unknown origin) or PE (chest pain, shortness of breath, hypoxemia, tachycardia or fever of unknown origin, productive cough with bloody sputum).|30 days|One participant in the control arm was lost to follow-up precluding outcome assessment.|||Participants|||Count of Participants
2542131|NCT03006341|Secondary|Percentage of Patients With Use of Antiplatelets or Non-steroidal Anti-inflammatory Drugs|Percentage of patients with use of antiplatelets or non-steroidal anti-inflammatory drugs (NSAIDs). Includes use of aspirin, clopidogrel, prasugrel, ticagrelor or NSAIDs (within 1 month or on the index date) in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.|Up to 1 month|Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.|||Percentage of patients|||Number
2542140|NCT03006341|Secondary|EMR Characteristic: Duration of Atrial Fibrillation|EMR characteristic: Duration of atrial fibrillation (Years / months prior to initiation of Dabigatran / Warfarin). Duration is defined as number of months prior to index date for the earliest note. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.|Up to 12 months|Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures. Duration calculated for patients identified as having condition in EMR.|||Months||Standard Deviation|Mean
2542909|NCT02989727|Primary|Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)|Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.|Seven weeks||||Participants|||Count of Participants
2542132|NCT03006341|Secondary|EMR Characteristic: Hypertension, Abnormal Liver/Renal Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio, Elderly, Drugs/Alcohol Usage (HAS-BLED) Score|EMR characteristic: HAS-BLED Score. HAS-BLED score is calculated by adding the specified points for each of the conditions listed below. Hypertension (uncontrolled), Abnormal renal and liver function, Stroke, Bleeding history or predisposition (anemia), Labile International Normalized Ratio (INR), Elderly, Drugs or alcohol (1 point each). Labile INR is defined as as the most recent INR <2 or >3 prior to cohort entry. Conditions are considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.|Up to 12 months|Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures. Also the patients with data for all HAS-BLED components.|||Unit on Scale||Standard Deviation|Mean
2542133|NCT03006341|Secondary|Percentage of Patients With Hyperlipidemia|Percentage of patients with hyperlipidemia is presented, defined as any note of hyperlipidemia, dyslipidemia or Low Density Lipoprotein (LDL) >130 mg/dl in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.|Up to 12 months|Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.|||Percentage of patients|||Number
2542134|NCT03006341|Secondary|Percentage of Patients With Diabetes|Percentage of patients with any note of diabetes type I or II in the electronic medical records (EMR) is presented. Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.|Up to 12 months|Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.|||Percentage of patients|||Number
2542135|NCT03006341|Secondary|Percentage of Patients With Prior Transient Ischemic Attack|Percentage of patients with any note of prior transient ischemic attack in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.|Up to 12 months|Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.|||Percentage of patients|||Number
2542136|NCT03006341|Secondary|EMR Characteristic: History/Duration of Congestive Heart Failure (CHF)|EMR characteristic: History/duration of Congestive Heart Failure (CHF). Duration is defined as number of months prior to index date for the earliest note. Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.|Up to 12 months|Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.|||Months||Standard Deviation|Mean
2542137|NCT03006341|Secondary|Percentage of Patients With Uncontrolled Hypertension|"Percentage of patients with uncontrolled hypertension; defined as SBP >160 mmHg using the most recent information prior to index date in the electronic medical records (EMR). The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available."|Up to 12 months|Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.|||Percentage of patients|||Number
2542138|NCT03006341|Secondary|EMR Characteristic: History/Duration of Hypertension|EMR characteristic: History/duration of hypertension. Any note of: Hypertension systolic blood pressure (SBP) >120 millimeters of mercury (mmHg) Hypertension drugs. Duration is defined as number of months prior to index date for the earliest note. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.|Up to 12 months|Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.|||Months||Standard Deviation|Mean
2542139|NCT03006341|Secondary|EMR Characteristic: History of Adherence: Non-adherent/Adherent|EMR characteristic: History of adherence: non-adherent/adherent.|Up to 12 months|Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures. Although the original intent was to document the patient’s history of adherence, no such information was available in the EMR||||||
2542174|NCT03004911|Secondary|Severity of Symptoms Assessed With the Symptom Severity Scale|Minimum value: 0. Maximum value: 12. Higher scores mean worse outcome.|6 weeks||||score on a scale||Standard Deviation|Mean
2542175|NCT03004911|Secondary|Pain Assessed With the Visual Analogue Scale|Minimum value: 0. Maximum value: 10. Higher scores mean worse outcome.|6 weeks||||score on a scale||Standard Deviation|Mean
2542141|NCT03006341|Primary|Percentage of Patients With Abnormal Liver Function|"Percentage of patients with abnormal liver function; defined as Any note of: Liver disease, cirrhosis, Active hepatitis C, Active hepatitis B, Active hepatitis A, aspartate transaminase/alanine transaminase (AST/ALT) >3 times upper limit of normal in the electronic medical records (EMR). Absence of any note would be considered as absence of the disease. Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available."|Up to 12 months|Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.|||Percentage of patients|||Number
2542142|NCT03006341|Primary|EMR Characteristic: Serum Creatinine|EMR characteristic: Serum Creatinine closest to index dispensing. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.|Up to 12 months|Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.|||Milligrams per deciliter||Standard Deviation|Mean
2542143|NCT03006341|Primary|EMR Characteristic: Renal Function - Glomerular Filtration Rate (GFR)|EMR characteristic: Renal function - Glomerular Filtration Rate (GFR). Estimated GFR closest to index dispensing. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.|Up to 12 months|Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.|||Milliliter/minute/1.73 square meter||Standard Deviation|Mean
2542144|NCT03006341|Primary|Percentage of Patients With Bleeding History or Predisposition|Percentage of patients with bleeding history or predisposition is presented, defined as any note of major bleeding requiring hospitalization or blood transfusion or causing a decrease in hemoglobin level of > 2 gram per liter (g/L) in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.|Up to 12 months|Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.|||Percentage of patients|||Number
2542145|NCT03006341|Primary|Percentage of Patients With Abnormal Renal Function|"Percentage of patients with abnormal renal function; defined as Any note of: Dialysis, renal transplant Serum Creatinine >1.3 Milligrams per Deciliter (mg/dL) in the electronic medical records (EMR). Response was considered to be truly absent if not recorded in the EMR. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available."|Up to 12 months|Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.|||Percentage of patients|||Number
2542146|NCT03006341|Primary|Percentage of Patients With Alcohol Consumption|Percentage of patients with alcohol consumption in the electronic medical records (EMR) are presented. The patients with light to moderate, heavy and unknown quantity of alcohol consumption are considered. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.|Up to 12 months|Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.|||Percentage of patients|||Number
2542147|NCT03006341|Primary|Percentage of Patients Smoking|Percentage of patients with current/past smoking in the electronic medical records (EMR) are presented. The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available.|Up to 12 months|Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.|||Percentage of patients|||Number
2542148|NCT03006341|Primary|Percentage of Patients With Obesity|"Percentage of patients with obesity; where obesity is defined as obese, not-obese based on note of obesity or recorded body mass index (BMI) > 30 in the electronic medical records (EMR). The results are provided before and after propensity score (PS) matching. Before PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR whose data were available; After PS matching: all patients meeting inclusion/exclusion criteria successfully linked to EMR, 1:1 propensity score matched, whose data were available."|Up to 12 months|Two sets of results are provided, before and after PS matching. Rivaroxaban and Apixaban correspond to post-hoc analyses not pre-specified in the protocol and hence not included in the outcome measures.|||Percentage of patients|||Number
2542176|NCT03004911|Secondary|Number of Painful Areas Assessed With the Widespread Pain Index|Minimum value: 0. Maximum value: 19.|6 weeks||||number of painful areas||Standard Deviation|Mean
2542177|NCT03004911|Primary|Health-related Quality of Life Assessed With the Revised Fibromyalgia Impact Questionnaire|Minimum value: 0. Maximum value: 100. Higher scores mean worse outcome.|6 weeks||||score on a scale||Standard Deviation|Mean
2542149|NCT03005067|Secondary|Average Total Symptom Score Over Days 1-7 (ATSS1-7)|The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). The participants self-assessed each individual sign/symptom which was scored using the following 4 point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);Score range (Min-Max):0-24. Average Total Symptom Score (ATSS) on days 1 to 7 were derived as the mean of all TSS across study Days 1 to 7. A lower score reflects better nasal symptoms.|Up to Day 7 (Day 1 to 7)|Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2542150|NCT03005067|Secondary|Average Total Symptom Score Over Days 1-4 (ATSS1-4)|The total symptom scores (TSS) were calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing) and other symptoms (headache, muscle ache, chills, sore throat and cough). The participants self-assessed each individual sign/symptom which was scored using the following 4 point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);Score range (Min-Max):0-24. Average Total Symptom Score (ATSS) on days 1 to 4 were derived as the mean of all TSS across study Days 1 to 4. A lower score reflects better nasal symptoms.|Up to Day 4 (Day 1 to 4)|Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2542151|NCT03005067|Secondary|Average Nasal Symptom Score Over Days 1-7 (ANSS1-7)|The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 7 was calculated as the mean of the 7 daily NSS across study days 1 to 7. A lower score reflects better nasal symptoms.|Up to Day 7 (Day 1 to 7)|Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2542152|NCT03005067|Primary|Average Nasal Symptom Score Over Days 1-4 (ANSS1-4)|The nasal symptom score (NSS) was calculated as the sum score of the nasal symptoms (runny nose, blocked nose and sneezing). The participants self-assessed each individual sign/symptom which was scored using the following 4-point scale: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping);score range (Min-Max): 0-9 . The average nasal symptom score (ANSS) on days 1 to 4 was calculated as the mean of the 4 daily NSS across study days 1 to 4. A lower score reflects better nasal symptoms.|Up to Day 4 (Day 1 to 4)|Modified Intent-to-Treat(mITT) population was the primary population of analysis. The mITT (N=165) population was defined as participants who received at least one dose of study medication and have at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2542153|NCT03005041|Secondary|Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)|Participants rated the following criteria on a scale of 1 to 5(1=Poor, 2= Fair, 3= Good, 4= Very good, 5= Excellent) as follows: 1. Having an immediate dry mouth relief, 2. Having an immediate lubricating effect, 3. Having an immediate moisturizing effect.|Within 5 minutes post product use|Analysis for this outcome was performed on ITT population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment.|||Participants|||Count of Participants
2542154|NCT03005041|Secondary|Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)|Participants answered the following question; Q1: Are you experiencing any of the following sensations in your mouth and how strong is the sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Q2: Would you continue use of the product? (Yes or No)|Within 30 ± 5 minutes post product use|Analysis for this outcome was performed on ITT population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment.|||Participants|||Count of Participants
2542155|NCT03005041|Secondary|Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7|"Participants answered the following questions, Q3: Which of following statements best describes how much you liked product overall? liked it-extremely, very much, somewhat, slightly, did not like it that much, did not like it at all. Q 4: Which of the following statements best describes how much you liked overall flavor of rinse? liked it-extremely, very much, somewhat, slightly, did not like it that much, did not like it at all. Q 5: How you would rate flavor intensity of oral rinse? strongest flavor imaginable, very strong, strong, moderate, weak, barely detectable, no flavor at all. Q 6: Did you experience any of following sensations in your mouth & how strong was sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Participants who selected None for a particular sensation, did not complete Q 7 for that sensation: When did you experience sensations in your mouth? initially, during use, or after use."|Within 2 minutes post product use|ITT population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment. Note: Number of participants who answered question 6 proceeded to answer question 7. Participants also chosen more than one answer for question 7.|||Participants|||Count of Participants
2542156|NCT03005041|Primary|Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1|"Participants answered the following question, Q1: how much do you agree or disagree with the following statements about this product, having used it? This product is gentle: disagree strongly, disagree, neither agree nor disagree, agree, or agree strongly. There was no formal statistical hypothesis to be tested for this outcome.."|Within 2 minutes post product use|Analysis for this outcome was performed on intent to treat (ITT) population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment.|||Participants|||Count of Participants
2542157|NCT03004924|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Any AE that occured after the first dose of investigational product instillation was considered a TEAE.|From start of study drug administration up to 14 days|Safety population included all participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2542158|NCT03004924|Secondary|Number of Participants Who Used Rescue Medication|Rescue treatment with a licensed antibiotic according to the local standard of care was provided to participants if, in the judgment of the investigator, there was no clinical improvement or worsening of their condition to an extent that it would be in the best interest of the participant treated with an alternate therapy for safety reasons.|Baseline to Day 12|mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||Participants|||Count of Participants
2542159|NCT03004924|Secondary|Time to Clinical Resolution|Clinical resolution was defined as absence (score of 0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Time to clinical resolution defined as the date on which a participant first reached clinical resolution minus the date of first dose of investigational product, plus 1.|Baseline to Day 12|mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study.|||Days||95% Confidence Interval|Median
2542160|NCT03004924|Secondary|Number of Participants With Expanded Clinical Resolution|Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.|Day 3, 5, 8 and 12|mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||Participants|||Count of Participants
2542161|NCT03004924|Secondary|Number of Participants With Modified Clinical Resolution|Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.|Day 3, 5, 8 and 12|mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||Participants|||Count of Participants
2542162|NCT03004924|Secondary|Change From Baseline in the Global Clinical Score|Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.|Baseline, Day 3, 5, 8 and 12|mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||Score on a scale||Standard Deviation|Mean
2542163|NCT03004924|Secondary|Global Clinical Score|Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.|Day 3, 5, 8 and 12|mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||Score on a scale||Standard Deviation|Mean
2542164|NCT03004924|Secondary|Change From Baseline in the Ocular Conjunctival Discharge Score|Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.|Baseline, Day 3, 5, 8 and 12|mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||Score on a scale||Standard Deviation|Mean
2542165|NCT03004924|Secondary|Ocular Conjunctival Discharge Score|Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale.|Day 3, 5, 8 and 12|mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||Score on a scale||Standard Deviation|Mean
2542166|NCT03004924|Secondary|Change From Baseline in the Bulbar Conjunctival Injection Score|Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.|Baseline, Day 3, 5, 8 and 12|mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||Score on a scale||Standard Deviation|Mean
2542167|NCT03004924|Secondary|Bulbar Conjunctival Injection Score|Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale.|Day 3, 5, 8 and 12|mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||Score on a scale||Standard Deviation|Mean
2542168|NCT03004924|Secondary|Number of Participants With Bacterial Eradication|Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant.|Day 3, 8 and 12|mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study.|||Participants|||Count of Participants
2542169|NCT03004924|Secondary|Number of Participants With Clinical Resolution|Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of atleast 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline.|Day 3, 8 and 12|mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||Participants|||Count of Participants
2542170|NCT03004924|Secondary|Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5|Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.|Baseline, Day 5|mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.|||Participants|||Count of Participants
2542171|NCT03004924|Primary|Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5|Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%.|Day 5|Modified intent-to-treat (mITT) population included participants who received at least one dose of investigational product (IP) and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Analysis was done in SHP640 and placebo reporting groups only.|||Participants|||Count of Participants
2542172|NCT03004911|Secondary|Adherence to Mobile Application Assessed by Number of Clicks on the App Functions|Number of clicks on the app functions|6 weeks||||Clicks on app functions||Full Range|Median
2542173|NCT03004911|Secondary|Self-care Agency Assessed With the Appraisal of Self-Care Agency Scale - Revised|Minimum value: 15. Maximum value: 75. Higher scores mean better outcome.|6 weeks||||score on a scale||Standard Deviation|Mean
2542178|NCT03004846|Secondary|Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score: Part A|The PASI is a standard tool for assessing the severity of psoriasis that considers the overall severity of erythema, thickness, and scale, as well as the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0=none to 4=severe) and the percent BSA affected is scored on a 7-point scale (0= 0% skin with psoriasis to 6=>=90% skin with psoriasis) for each of the 4 specified body regions. The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.|Baseline and up to Week 8|PP analysis Population|||Percent change||Standard Deviation|Mean
2542179|NCT03004846|Secondary|Mean Percent Change From Baseline in Physician's Global Assessment (PGA) Score: Part A|The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. The 5-point scale ranges from 0=clear to 4=severe. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Percent change from Baseline was calculated by dividing change from baseline value by Baseline value and multiplying it by 100.|Baseline and up to Week 8|PP analysis Population|||Percent change||Standard Deviation|Mean
2542180|NCT03004846|Secondary|Mean Percent Change From Baseline in Target Plaque Severity Score (TPSS): Part A|The TPSS is the measure of clinical effect of GSK2981278. A target lesion of at least 9 centimeter square (cm^2) with a TPSS >=5 and an induration sub score >=2 was selected at Baseline. TPSS Total score was calculated by adding the individual scores of erythema, scaling, and induration (plaque thickness), assessed by the investigator on a 5-point scale ranging from 0=none to 4=very marked. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100. The analysis was performed on per protocol (PP) analysis Population which comprised of all participants eligible for treatment phase and who comply closely with the protocol.|Baseline and up to Week 8|PP analysis Population|||Percent change||Standard Deviation|Mean
2542181|NCT03004846|Primary|Mean Percent Change in PASI From Baseline to Week 8: Part B|The PASI is a standard tool for assessing the severity of psoriasis that considers the overall severity of erythema, thickness, and scale, and the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0=none to 4=severe) and the percent BSA affected is scored on a 7-point scale (0= 0% skin with psoriasis to 6=>=90% skin with psoriasis). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease. Last observation values collected were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Percent change from Baseline was calculated by dividing change from baseline value by Baseline value and multiplying it by 100. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Baseline and up to Week 8|PP analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.||||||
2542182|NCT03004846|Primary|Mean Percent Change in PGA Score From Baseline to Week 8: Part B|The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. The 5-point scale ranges from 0=clear to 4=severe. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as by subtracting post-Baseline visit values minus Baseline value. Percent change from Baseline was calculated by dividing change from baseline value by Baseline value and multiplying it by 100. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Baseline and up to Week 8|PP analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.||||||
2542183|NCT03004846|Primary|Mean Percent Change in TPSS From Baseline to Week 8: Part B|The TPSS is the measure of clinical effect of GSK2981278. TPSS Total score was calculated by adding the individual scores of erythema, scaling, and induration (plaque thickness), assessed by the investigator on a 5-point scale ranging from 0=none to 4=very marked. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Baseline and up to Week 8|PP analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.||||||
2542184|NCT03004846|Primary|Number of Participants With Abnormal Findings for ECG Parameters: Part B|Single measurements of 12-lead ECGs were planned to be obtained using an ECG machine. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to Day 57|Safety analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.||||||
2542185|NCT03004846|Primary|Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug: Part B|Vital sign measurement includes SBP, DBP, temperature, pulse rate. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to Day 57|Safety analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.||||||
2542186|NCT03004846|Primary|Number of Participants With Change in Hematology Toxicity Grade From Baseline: Part B|Blood samples were planned to be collected for the analysis of hematology parameters. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Baseline and up to Day 57|Safety analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.||||||
2542187|NCT03004846|Primary|Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline: Part B|Blood samples were planned to be collected for evaluation of clinical chemistry parameters. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as by subtracting post-Baseline visit values minus Baseline value. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Baseline and up to Week 57|Safety analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.||||||
2542188|NCT03004846|Primary|Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part B|The investigator planned to assess application site tolerability focusing on the treated non-lesional skin surrounding the plaques at each visit using the 5-point tolerability assessment scale ranging from 0 (no intolerance) to 4 (very severe intolerance). Number of participants with Application site tolerability assessment score were planned to be analyzed. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to Day 57|Safety analysis Population. Data was not collected for Part B as no Participants were enrolled into this part of the study.||||||
2542189|NCT03004846|Primary|Number of Participants With SAEs and Non-SAEs: Part B|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. The analysis was performed on Safety analysis set Population which comprised of all participants exposed to at least 1 application of study medication. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to Day 57|Safety analysis population. . Data was not collected for Part B as no Participants were enrolled into this part of the study.||||||
2542190|NCT03004846|Primary|Plasma Concentration of GSK2981278 at Nominal Time: Part A|Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK2981278. Non-quantifiable values in a profile occurring before the first measurable concentration were assigned a value of zero concentration. Single non-quantifiable values occurring between measurable concentrations in a profile were omitted. The analysis was performed on PK analysis Population which comprised of participants with at least one sample collected and analyzed for plasma drug concentration. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose, 1, 2, 4, 6, 8, 10 hours post-dose on Day 1, Day 29 and Day 57; Pre-dose, 2 hours post-dose on Day 15|PK analysis Population|||Picograms per milliliter (Pg/mL)||Standard Deviation|Mean
2542191|NCT03004846|Primary|Change From Baseline in ECG Parameters Including PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and RR Interval: Part A|Single measurements of 12-lead ECG were obtained using an ECG machine to measure PR interval, QRS duration, QT interval, QTcB and RR interval. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value|Baseline and up to Day 57|Safety analysis Population|||Milliseconds (msec)||Standard Deviation|Mean
2542192|NCT03004846|Primary|Change From Baseline in Electrocardiogram (ECG) Parameters Including Single RR Heart Rate: Part A|Single measurements of 12-lead ECG were obtained using an ECG machine to measure RR heart rate. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value|Baseline and up to Day 57|Safety analysis Population|||Beats per minute||Standard Deviation|Mean
2542193|NCT03004846|Primary|Change From Baseline in Pulse Rate Levels: Part A|Vital sign measurements including pulse rate were taken in a seated or supine position after 5-minutes of rest. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.|Baseline and up to Day 57|Safety analysis Population|||Beats per minute||Standard Deviation|Mean
2542194|NCT03004846|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels: Part A|Vital sign measurements including SBP and DBP were taken in a seated or supine position after 5-minutes of rest. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.|Baseline and up to Day 57|Safety analysis Population|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2542195|NCT03004846|Primary|Change From Baseline in Mean Corpuscular Hemoglobin (MCH) Levels: Part A|Blood samples were collected from participants to evaluate clinical hematology parameters including MCH. Change from Baseline in clinical hematology parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.|Baseline and up to Day 57|Safety analysis Population|||Picograms (Pg)||Standard Deviation|Mean
2542196|NCT03004846|Primary|Change From Baseline in Mean Corpuscular Volume (MCV) Levels: Part A|Blood samples were collected from participants to evaluate clinical hematology parameters including MCV. Change from Baseline in clinical hematology parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.|Baseline and up to Day 57|Safety analysis Population|||Femtoliter (fL)||Standard Deviation|Mean
2542197|NCT03004846|Primary|Change From Baseline in Hematocrit Levels: Part A|Blood samples were collected from participants to evaluate clinical hematology parameters including hematocrit. Change from Baseline in clinical hematology parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.|Baseline and up to Day 57|Safety analysis Population|||Proportion of Red blood cells in blood||Standard Deviation|Mean
2542910|NCT02989727|Primary|Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)|Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.|Eight weeks||||Participants|||Count of Participants
2542199|NCT03004846|Primary|Change From Baseline in Erythrocyte Levels: Part A|Blood samples were collected from participants to evaluate clinical hematology parameters including erythrocytes. Change from Baseline in clinical hematology parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.|Baseline and up to Day 57|Safety analysis Population|||10^12 cells/L||Standard Deviation|Mean
2542200|NCT03004846|Primary|Change From Baseline in Platelet, Leukocyte, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils Levels: Part A|Blood samples were collected from participants to evaluate clinical hematology parameters including platelets, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Change from Baseline in clinical hematology parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.|Baseline and up to Day 57|Safety analysis Population|||10^9 cells/L||Standard Deviation|Mean
2542201|NCT03004846|Primary|Change From Baseline in Protein and Albumin Levels: Part A|Blood samples were collected from participants to evaluate clinical chemistry parameters including protein and albumin. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.|Baseline and up to Day 57|Safety analysis Population|||Grams per liter (g/L)||Standard Deviation|Mean
2542202|NCT03004846|Primary|Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase Levels: Part A|Blood samples were collected from participants to evaluate clinical chemistry parameters including AST, ALT and alkaline phosphatase. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.|Baseline and up to Day 57|Safety analysis Population|||International unit per liter (IU/L)||Standard Deviation|Mean
2542203|NCT03004846|Primary|Change From Baseline in Creatinine, Total and Direct Bilirubin Levels: Part A|Blood samples were collected from participants to evaluate clinical chemistry parameters including creatinine, total and direct bilirubin. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.|Baseline and up to Day 57|Safety analysis Population|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2542204|NCT03004846|Primary|Change From Baseline in Blood Urea Nitrogen (BUN), Glucose, Potassium, Sodium and Calcium Levels: Part A|Blood samples were collected from participants to evaluate clinical chemistry parameters including BUN, glucose, potassium, sodium and calcium. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.|Baseline and up to Day 57|Safety analysis Population|||Millimoles per liter (Mmol/L)||Standard Deviation|Mean
2542205|NCT03004846|Primary|Change From Baseline in Specific Gravity of Urine: Part A|Urine samples were collected from participants and specific gravity levels were assessed at Baseline, Day 15, Day 29 and Day 57. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.|Baseline and up to Day 57|Safety analysis Population|||Ratio||Standard Deviation|Mean
2542206|NCT03004846|Primary|Change From Baseline in Potential of Hydrogen (pH) of Urine: Part A|The pH scale measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic. Urine samples were collected from participants and urine pH levels were assessed at Baseline, Day 15, Day 29 and Day 57. Last observation values collected prior to the first application of study treatment were considered as Baseline values. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.|Baseline and up to Day 57|Safety analysis Population|||Scores on a scale||Standard Deviation|Mean
2542207|NCT03004846|Primary|Number of Participants With Negative Urinalysis Results: Part A|Urine samples were collected from participants to evaluate urinalysis parameters including glucose, protein, erythrocytes and ketones. Number of participants with negative or normal urinalysis results at Day 15, Day 29 and Day 57 are presented. Last observation values collected prior to the first application of study treatment were considered as Baseline values.|Up to Day 57|Safety analysis Population|||Participants|||Number
2542208|NCT03004846|Primary|Number of Participants With Application Site Tolerability Assessment Score During Treatment Period: Part A|The investigator assessed application site tolerability focusing on the treated non-lesional skin surrounding the plaques at each visit using the 5-point tolerability assessment scale ranging from 0 (no intolerance) to 4 (very severe intolerance). Number of participants in the corresponding score at Day 1, 15, 29 and 57 has been presented.|Day 1, Day 15, Day 29, Day 57|Safety analysis Population|||Participants|||Number
2542209|NCT03004846|Primary|Number of Participants With On-treatment Serious Adverse Events (SAEs) and Non-SAEs: Part A|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. The analysis was performed on Safety analysis Population which comprised of all participants exposed to at least 1 application of study medication.|Up to Day 57|Safety analysis Population|||Participants|||Number
2542210|NCT03004638|Secondary|Number of Participants With Positive Anti-Drug Antibodies for MEDI6012|Participants with positive serum antibodies to MEDI6012 were reported.|For Cohorts 1 to 3 and Placebo arm: Pre-dose on Days 1 and 15, and on Days 29, 43, and 71; For Cohort 4 and Placebo IV push arm: Pre-dose on Days 1 and 10, and on Days 24, 38, and 66.|Immunogenicity population included all participants in the as-treated population who had at least one serum sample for immunogenicity testing|||Participants|||Count of Participants
2542211|NCT03004638|Secondary|Area Under the Concentration Time Curve to Last Measurable Time Point (AUClast) of MEDI6012|The area under the concentration time-curve to the last measured concentration after the third dose of MEDI6012 was reported.|Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; AUClast following the third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.|PK population. The AUClast was not reported following first dose in Cohort 4 since NCA was not performed due to dosing period was only 48 hrs. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.|||µg*day/mL||Standard Deviation|Mean
2542212|NCT03004638|Secondary|Terminal Half-life (t1/2) of MEDI6012|The t1/2 is the time measured for the serum concentration to decrease by one half after the third dose of MEDI6012.|The t1/2 following third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.|PK population included all participants in the as-treated population who had at least one detectable LCAT serum concentration measurement. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.|||Days||Standard Deviation|Mean
2542213|NCT03004638|Secondary|Accumulation Ratio (Rac) of MEDI6012|The accumulation ratio (Rac) is defined as the ratio of accumulation of a study drug going from a single dose to steady state with repeated administration. Accumulation ratio was reported on the basis of maximum concentration (ARC max) and area under the concentration-time curve (ARAUC).|Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; The Rac following third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.|PK population. The Rac was not calculated for Cohort 4 as the first dose regimen (300 mg loading dose follow by 2nd dose given 48 hours later, therefore NCA was not performed for Dose 1) are different from 3rd dose (100 mg). The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.|||Ratio||Standard Deviation|Mean
2542214|NCT03004638|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of MEDI6012|The time to reach the maximum observed serum concentration following the first and third dose of MEDI6012 was reported.|Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; Tmax following the third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.|PK population included all participants in the as-treated population who had at least one detectable LCAT serum concentration measurement. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.|||Hours||Standard Deviation|Mean
2542215|NCT03004638|Secondary|Maximum Observed Serum Concentration (Cmax) of MEDI6012|The maximum observed serum concentration following the first and third dose of MEDI6012 was reported.|Day 1 end of infusion to Day 8 predose for Cohorts 1 to 3; Day 1 end of infusion to Day 3 predose for Cohort 4; Cmax following the third dose: Day 15 end of infusion to Day 71 for Cohort 1 to 3; Day 10 end of infusion to Day 65 for Cohort 4.|PK population included all participants in the as-treated population who had at least one detectable LCAT serum concentration measurement. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.|||μg/mL||Standard Deviation|Mean
2542216|NCT03004638|Secondary|Change From Baseline in Serum Concentration for Total LCAT Activity|Lecithin-cholesterol acyltransferase (LCAT) is a plasma enzyme secreted by the liver. Serum LCAT activity was estimated to provide an alternative measure to LCAT mass in establishing the relationship between pharmacokinetics and pharmacodynamics of MEDI6012. Change in LCAT activity from baseline (pre-dose of each dose) to post doses was reported (concentration at Days 8, 15, and 22 for Cohorts 1 to 3 and placebo; Concentration at Days 3, 10, and 17 for Cohort 4 and placebo IV push arm).|Seven days post-dose following Doses 1 to 3 in Cohorts 1 to 3 and placebo arm (Days 8, 15, 22); 2 days post-dose following Dose 1 (Day 3) and 7 days post-dose following Doses 2 and 3 (Days 10, 17) in Cohort 4 and placbo IV push.|PK population included all participants in the as-treated population who had at least one detectable LCAT serum concentration measurement. LCAT activity at Day 3 and Day 17 were not collected for Cohort 4. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.|||μg/mL||Standard Deviation|Mean
2542217|NCT03004638|Secondary|Change From Baseline in Serum Concentration for MEDI6012 Mass|The trough concentration level of MEDI6012 following each dose is reported (concentration at Days 8, 15, and 22 for Cohorts 1 to 3 and placebo; Concentration at Days 3, 10, and 17 for Cohort 4 and placebo IV push arm).|Seven days post-dose following Doses 1 to 3 in Cohorts 1 to 3 and placebo arm (Days 8, 15, 22); 2 days post-dose following Dose 1 (Day 3) and 7 days post-dose following Doses 2 and 3 (Days 10, 17) in Cohort 4 and placbo IV push.|Pharmacokinetic (PK) population included all participants in the as-treated population who had at least one detectable lecithin-cholesterol acyltransferase (LCAT) serum concentration measurement. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.|||μg/mL||Standard Deviation|Mean
2542218|NCT03004638|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Apolipoprotein B|The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of Apolipoprotein B.|Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.|As-treated population included all participants who received at least one dose of study drug. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.|||mg*h/dL||Standard Deviation|Mean
2542219|NCT03004638|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Low-density Lipoprotein Cholesterol (LDL-C).|The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of LDL-C.|Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.|As-treated population included all participants who received at least one dose of study drug. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.|||mg*h/dL||Standard Deviation|Mean
2542911|NCT02989727|Primary|Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)|Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.|One week||||Participants|||Count of Participants
2542220|NCT03004638|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Apolipoprotein A1|The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of Apolipoprotein A1.|Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.|As-treated population included all participants who received at least one dose of study drug. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.|||mg*h/dL||Standard Deviation|Mean
2542221|NCT03004638|Primary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for Cholesterol Ester|The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of cholesterol ester.|Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.|As-treated population included all participants who received at least one dose of study drug. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.|||mg*h/dL||Standard Deviation|Mean
2542222|NCT03004638|Primary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for High-density Lipoprotein-cholesterol Ester (HDL-CE)|The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of high-density lipoprotein-cholesterol ester.|Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.|As-treated population included all participants who received at least one dose of study drug.The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.|||mg*h/dL||Standard Deviation|Mean
2542223|NCT03004638|Primary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hour (hr) (AUC [0-96 hr]) Post Dose 3 for High-density Lipoprotein-cholesterol (HDL-C)|The AUC (0-96 hr) is the area under the concentration-time curve from time 0 to 96 hrs of high-density lipoprotein-cholesterol.|Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 15 dose (third dose) for Cohorts 1 to 3 and Placebo arm; Pre-dose, end of infusion, 12, 24, and 96 hrs post Day 10 dose (third dose) for Cohort 4 and Placebo IV push arm.|As-treated population included all participants who received at least one dose of study drug. The overall number of participants analyzed denotes the number of participants evaluated specific for this outcome measure.|||mg*h/dL||Standard Deviation|Mean
2542224|NCT03004638|Primary|Number of Participants With Abnormal Electrocardiogram Reported as TEAEs|Treatment-emergent adverse events observed in participants with clinically significant ECG abnormalities are reported.|From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)|As-treated population included all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2542225|NCT03004638|Primary|Number of Participants With Abnormal Vital Signs Reported as TEAEs|Treatment-emergent adverse events observed in participants with clinically significant vital signs abnormalities are reported. Vital sign parameters included blood pressure, respiration rate, heart rate, pulse oximetry, and body temperature.|From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)|As-treated population included all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2542226|NCT03004638|Primary|Number of Participants With Abnormal Clinical Laboratory Evaluations Reported as TEAEs|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator as medically significant was reported as an AE. Laboratory evaluations included haematology, serum chemistry, and urinalysis.|From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)|As-treated population included all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2542227|NCT03004638|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience(immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first dose of study drug and up to 56 days after last dose of study drug (Day 66 for Cohort 4 and placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm) that were absent before treatment or that worsened relative to pre-treatment state.|From Day 1 to Day 56 after last dose of study drug (Day 66 for Cohort 4 and Placebo IV push arm and Day 71 for Cohorts 1 to 3 and placebo arm)|As-treated population included all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2542228|NCT03004534|Secondary|Number of Participants With Treatment-related Adverse Events (TEAE) as Assessed by CTCAE v4.03|"The assessment of safety will be performed for all subjects who have taken at least one tablet of darolutamide (defined as the safety population)"|1 year, 6 months||||Participants|||Count of Participants
2542229|NCT03004534|Primary|Identifying Molecular Alterations in Breast Cancer Tissue Tumor Samples Following Short-Term Preoperative Exposure to Darolutamide in Female Patients Wit Early Breast Cancer.|Androgen Receptor (AR) was assessed on the collected samples.|1 year, 6 months|36 patients were enrolled, however 34 patients were evaluable based on the molecular criteria: Adequacy (evaluated by the central laboratory) for molecular assessment of the tumor tissue collected before and after the protocol treatment initiation. Expression levels were evaluated by microarray using the patient’s RNA.|||Participants|||Count of Participants
2542279|NCT03002610|Secondary|Reading Experience|This section of the survey will include 5 questions about the experience of participants about the text they read, measured on a 10-point Likert type scale, where 1 means do not agree at all and 10 means fully agree. The total score is the sum of scores on all five answers (minimum 5, maximum 50). Higher scores would indicate higher, or more positive, reading experience.|One month (30 days)||||units on a scale||95% Confidence Interval|Median
2553989|NCT02764970|Secondary|Number of Participants With Use of i.v. Betablocker|measured in mg metoprolol used|time from first ECG in the CT-room to start of CT scan (average of 10 minutes)||||participants|||Number
2542230|NCT03004469|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs|An Adverse event is defined as any untoward medical occurrence in a participants or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with treatment. A serious AE was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect and medically significant event. The Treatment Emergent Adverse Events (TEAEs) is defined as all AEs occurring on or after the first dose of the IMP.|From the start of IMP up to 28 weeks|Safety Population includes all randomized participants who received at least one application of the IMP.|||participants|||Number
2542231|NCT03004469|Secondary|Local Tolerability as Assessed by Incidence Rate of Skin Irritation Event Via Severity Score for Skin Irritation Scale|"Local tolerability at the application site was assessed to rate the severity of any skin irritation. The Investigator used the Severity score for skin Irritation scale to assess local tolerability. The dermal response and other effects indicative irritation responses were recorded at time of examination. Anything other than No evidence of irritation under Dermal Response was considered as a Dermal Response Skin Irritation event. Anything other than No other effects under Other Effects was considered as an Other Effects of Skin Irritation event. The event incidence rate is calculated as the number of events interest divided by total personal time in years."|Baseline to Week 24|Safety Population includes all randomized participants who received at least one application of the IMP.|||Events per personal years|||Number
2542232|NCT03004469|Secondary|Adjusted Mean International Index of Erectile Function (IIEF-2) Scores at Weeks 4, 8, 12 and 24|The 15-question IIEF-2 Questionnaire (Sexual Function Questionnaire) was used to evaluate any changes in sexual function and activity, at Weeks 4, 8, 12 and 24. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. Erectile function domain has 6 questions with the score for domain range from 0-30. Orgasmic function domain has 2 questions with the score for domain range from 0-10. , Sexual desire function domain has 2 questions with the score for domain range from 0-10. Intercourse satisfaction function domain has 3 questions with the score for domain range from 0-15. Overall Satisfaction domain has 2 questions with the score for domain range from 0-10. A higher score indicated a worse outcome in that domain.|Weeks 4, 8, 12 and 24|ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.|||score on a scale||Standard Error|Mean
2542233|NCT03004469|Secondary|Adjusted Mean Change From Baseline in Participants Hair Growth/Loss at Weeks 12 and 24, Assessed for the Vertex by Blind Assessor|An independent blinded assessor was responsible for evaluating, under blinded conditions, the screening global photographs of the target area for all participants. They evaluated the eligibility of each participants according to the clinical inclusion criteria. The independent blinded assessor assessed the change of the hair growth from Baseline to Week 12 and from Baseline to Week 24, using a 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. This assessment was performed by comparing the global photographs obtained at screening visit with those subsequently obtained at Weeks 12 and 24. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects with an unstructured covariance structure.|Baseline, Week 12 and Week 24|ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.|||score on a scale||Standard Error|Mean
2542234|NCT03004469|Secondary|Adjusted Mean Change From Baseline in Participants Hair Growth/Loss Assessed for the Vertex by Investigator at Weeks 12 and 24|The local Investigator assessed change in hair growth from Baseline to Week 12 and from Baseline to Week 24, using a 7-point scale. The evaluation was done by the Investigator or designee, by comparing the global vertex view photograph obtained at baseline visit with the participants actual scalp at 12 and 24 weeks. For the purpose of assessment of changes in hair growth by Investigators screening visits (where global photos were taken) were used as Baseline. The change from Baseline in hair growth was assessed using the following 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects with an unstructured covariance structure.|Baseline, Week 12 and Week 24|ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.|||score on a scale||Standard Error|Mean
2542235|NCT03004469|Secondary|Adjusted Mean Overall Male Hair Growth Questionnaire (MHGQ) Score as Assessed by the Participant at Weeks 12 and 24|Participants assessed their scalp hair using a validated, self-administered MHGQ, which was given in their language. The self-administered MHGQ overall score assessed using the following 5-point scale: 1 = very satisfied, 2 = satisfied, 3 = neutral (neither satisfied nor dissatisfied), 4 = dissatisfied, 5 = very dissatisfied. A higher score indicated a worse outcome. The questionnaire was administered to eligible participants to subjectively measure their perception of hair growth. A higher score indicated a worse outcome.|Week 12 and Week 24|ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.|||score on a scale||Standard Error|Mean
2542236|NCT03004469|Secondary|Adjusted Mean Change From Baseline in Target Area Hair Width (TAHW) in the Vertex at Weeks 12 and 24|The change from baseline in the TAHW within a 1 cm^2 of baldness area at Weeks 12 and 24, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Weeks 12 and 24 minus baseline, respectively.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.|Baseline, Week 12 and Week 24|ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.|||Micrometer||Standard Deviation|Mean
2542237|NCT03004469|Secondary|Adjusted Mean Change From Baseline in Hair Growth Assessed by TAHC in the Vertex at Week 12|The change from baseline in the TAHC within a 1 cm^2 of baldness area at Week 12, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Week 24 minus baseline.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.|Baseline and Week 12|ITT Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.|||Hairs||Standard Deviation|Mean
2542238|NCT03004469|Primary|Adjusted Mean Change From Baseline in Hair Growth Assessed by Target Area Hair Count (TAHC) in the Vertex at Week 24|The change from baseline in the TAHC within a 1 cm^2 (square centimeter) of baldness area at Week 24, were assessed by macro photographic techniques analysis. The Investigator selected a target area in the anterior leading edge of the vertex thinning area. A small dot tattoo was placed in the center of the circle of the clipped hairs. Using the tattoo as a reference point, the circular area was photographed and a 1 cm^2 circular area within the target area was analysed. Change is the adjusted mean of Week 24 minus baseline.The analysis uses a covariance pattern model adjusted for treatment group, center, visit and treatment-by-visit interaction as fixed effects and baseline hair count as a covariate with an unstructured covariance structure.|Baseline and Week 24|Intent-to-Treat (ITT) Population included all participants who had measurements both at baseline and on treatment: i.e. participants who had measurements in regards to hair count both at baseline and on treatment.|||Hairs||Standard Deviation|Mean
2542239|NCT03003793|Primary|Insulin Sensitivity Difference Between Patients With Atopic Dermatitis and Controls|The outcome is determined by measuring the glucose necessary to maintain euglycaemia during increased insulin levels generated by continuous insulin infusion (measured as the M-value: the rate of glucose infused is equal to the rate of whole-body glucose disposal or metabolizable glucose (M) and reflects the amount of exogenous glucose necessary to fully compensate for the hyperinsulinemia)|Baseline, plasma glucose every 5 minutes, insulin/C-peptide, glucagon every 10-15 minutes throughout a 3 hour hyperinsulinaemic euglycaemic clamp||||mg glucose/kg body mass/minute||Standard Deviation|Mean
2542240|NCT03003520|Secondary|Participants With Treatment Emergent Adverse Events (TEAE) (Database Cutoff Date: 02-Aug-2018)|An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03): - Grade 1 = Mild (no limitation in activity or intervention); - Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); - Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); - Grade 4 = Life-threatening; - Grade 5 = Death. Relation to IP is determined by the investigator.|From the date of the first dose of study drug to within 90 days after the last dose of durvalumab or 28 days after the last dose of any investigational product (IP) whichever is greater. Day 1 up to Week 54 at time of database cutoff date.|Safety Population, which consists of all participants who received at least 1 dose of the study medications. Participants were analyzed in the arm of the actual treatment received.|||Participants|||Count of Participants
2542241|NCT03003520|Secondary|Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for the Interferon Gamma Score (IFNG-Score) From Ribonucleic Acid (RNA)-Sequencing Data|Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome.|Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).|The RNA Biomarker Analysis Set included all Efficacy Evaluable participants who have RNA Sequencing analysis performed on a biopsy sample and collected from the participant before treatment on the protocol. Population included participants who received durvalumab. Samples with whole transcriptome data of low quality were excluded from the set.|||percentage of participants|||Number
2542242|NCT03003520|Secondary|Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) Programmed Death Ligand - 1 (PDL1) Percentage of Tumor Cells|Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome.|Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).|The RNA Biomarker Analysis Set included all Efficacy Evaluable participants who have RNA Sequencing analysis performed on a biopsy sample and collected from the participant before treatment on the protocol. Population included participants who received durvalumab. Samples with whole transcriptome data of low quality were excluded from the set.|||percentage of participants|||Number
2542523|NCT02998684|Primary|Social Responsiveness Scale (SRS)|Change in SRS raw scores from pre- to post-treatment, i.e., baseline to 14-weeks (Pre minus post-treatment: positive scores indicate improvement). Raw scores range from 0 to 195, with higher scores indicating greater severity of symptoms.|Baseline to 14 weeks|Data for participants who completed all 14 weeks|||score on a scale||Standard Deviation|Mean
2542243|NCT03003520|Secondary|Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) Programmed Death Ligand - 1 (PDL1) Total Percentage|Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome.|Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).|The RNA Biomarker Analysis Set included all Efficacy Evaluable participants who have RNA Sequencing analysis performed on a biopsy sample and collected from the participant before treatment on the protocol. Population included participants who received durvalumab. Samples with whole transcriptome data of low quality were excluded from the set.|||percentage of participants|||Number
2542244|NCT03003520|Secondary|Percentage of Participants Who Achieved a Clinical Response in the Biomarker Subpopulation for Immunohistochemistry (IHC) CD8 T-Cell Density|Data in the analysis include all participants who received durvalumab, irrespective of the study arm in which they enrolled, because the selected biomarkers have been associated with response in other anti-PD1 or anti-PDL1 studies, such as durvalumab. IHC analysis was performed on the baseline tumor biopsy to quantify CD8 T-cell density. Participants with 'high' values, i.e. above the threshold defined as the median value of 774 cells/mm^2 found in commercial DLBCL samples using matched analytical methods, were predicted to be responders to treatment with durvalumab. The definition of a complete response was that used in the primary outcome.|Biomarker biopsies: Days -28 to Day -1. Clinical response: From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).|The RNA Biomarker Analysis Set included all Efficacy Evaluable participants who have RNA Sequencing analysis performed on a biopsy sample and collected from the participant before treatment on the protocol. Population included participants who received durvalumab. Samples with whole transcriptome data of low quality were excluded from the set.|||percentage of participants|||Number
2542245|NCT03003520|Secondary|Percentage of Participants Who Responded During Induction and Continued Into Consolidation Therapy (Database Cutoff Date: 02-Aug-2018)|The percentage of participants who achieved a partial response (PR) or complete response (CR) at the end of Induction and continued into consolidation period in the efficacy evaluable population in a comparative manner against historical control. The response to treatment was assessed according to the 2014 International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) (Cheson, 2014). CR was defined in outcome #1. PR was defined as a partial metabolic response and radiographic evidence showing ≥ 50% decrease in sum of perpendicular diameters (SPD) of up to 6 target measurable nodes and extranodal sites, no new lesions, spleen must have regressed > 50% in length beyond normal, and residual bone marrow involvement improved from baseline. Clopper-Pearson two-sided 95% confidence interval is reported. Null hypothesis was rejected if the lower limit of the confidence interval for the rate of subjects who continue consolidation therapy out of all subjects.|From first dose of study drug to completion of at least one cycle in the Consolidation Period (Day 1 up to Week 52)|Efficacy Evaluable Population includes participants who completed at least one cycle of their assigned treatment, had a baseline assessment by CT scan and at least one post baseline tumor response assessment.|||percentage of participants||95% Confidence Interval|Number
2542246|NCT03003520|Primary|Percentage of Participants Who Achieved a Complete Response (CR) at the End of Induction Therapy|The primary efficacy analysis evaluated the complete response rate (CRR) at the end of the induction therapy in the efficacy evaluable population in a comparative manner against historical control. The response to treatment was assessed according to the 2014 International Working Group (IWG) Response Criteria for Non-Hodgkin's Lymphoma (NHL) (Cheson, 2014). CR was defined as a complete metabolic response and radiographic evidence showing target nodes/nodal masses regressed to ≤ 1.5 cm in longest diameter, no new lesions, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. Clopper-Pearson two-sided 95% confidence interval is reported. Null hypothesis for the primary endpoint was rejected if the lower limit of the confidence interval for the complete response rate at the completion of the induction therapy in the efficacy evaluable population is above 55%.|From first dose of study drug to end of Induction therapy (Day 1 up to Week 26 - maximum duration of Induction Period).|Efficacy Evaluable Population includes participants who completed at least one cycle of their assigned treatment, had a baseline assessment by CT scan and at least one post baseline tumor response assessment.|||percentage of participants||95% Confidence Interval|Number
2542247|NCT03003494|Secondary|Patient Satisfaction With Handling of the Respimat® Inhalation Device|Patients were asked how satisfied they were with handling of the Respimat® inhalation device at Week 6 (approx.) (Visit 2).|After approx. 6 weeks of treatment initiation|FAS|||Participants|||Count of Participants
2542248|NCT03003494|Secondary|Patient Satisfaction With Inhaling From the Respimat® Device|Patients were asked how satisfied they were by inhaling with the Respimat® device at Week 6 (approx.) (Visit 2)|After approx. 6 weeks of treatment initiation|FAS|||Participants|||Count of Participants
2542249|NCT03003494|Secondary|Patient Overall Satisfaction With Spiolto® Respimat®|Patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment at Week 6 (approx.) (Visit 2).|After approx. 6 weeks of treatment initiation|FAS|||Participants|||Count of Participants
2542250|NCT03003494|Secondary|Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2|The patient's general condition was evaluated by means of Physician's Global Evaluation (PGE) score. The PGE score is documented on a scale from 1 (poor) to 8 (excellent) at both visits. 1-2: poor; 3-4: satisfactory; 5-6: good; 7-8: excellent|Baseline (visit 1) and after approx.week 6 (visit 2)|FAS|||Participants|||Count of Participants
2542251|NCT03003494|Secondary|The Median Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2|The change in PF-10 score was determined by taking into account the individual change of each patient between Baseline (Visit 1) and Week 6 (approx.) (Visit 2) and then the median for change from baseline values across all subjects was calculated.|Baseline (visit 1) and after approx. week 6 (visit 2)|FAS|||Unit on scale||Full Range|Median
2553990|NCT02764970|Primary|Heart Rate|number of beats per minute|intraoperative||||beats per minute||Standard Deviation|Mean
2542252|NCT03003494|Primary|Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2)|"Therapeutic success defined as at least 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment The PF-10 used for assessing the primary outcome physical functioning is a sub-domain of the validated Short Form 36 (SF-36 ) and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with yes, limited a lot, yes, limited a little or no, not limited at all, with a score of 1, 2 or 3. The sum of the scores of the 10 questions results in a value between 10 (a patient answering all questions with yes, limited a lot) and 30 (a patient answering all questions with no, not limited at all). The final sum of the individual scores was standardized to a range of 0 to 100 using the following formula: [(sum of scale items - 10) * 100] / 20. Higher scores indicate better physical functioning."|after approximately 6 weeks|Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed PF-10 questionnaire at both study visits.|||Percentage of Participants (%)||95% Confidence Interval|Number
2542253|NCT03003000|Secondary|Time to First Meaningful POMwp Relief Within 2 h After the First Dose of Trial Medication|"Time to event analysis of patients with first meaningful POMwp relief within 2 h after the first dose of trial medication. The percentage of observed patients with a meaningful POMwp relief within 2 h after the first dose of trial medication was reported. The procedure which resulted in the highest POM at baseline (POMwp) was repeated by the investigator 10, 20, 30, 60 and 120 min after the first dose of trial medication. The POMwp relief score (POMwpRS) was assessed by the patient at each of these time points by using a 5-point verbal rating scale (0 = no POMwp relief; 1 = little or perceptible POMwp relief; 2 = meaningful POMwp relief; 3 = a lot of POMwp relief; 4 = complete POMwp relief).~The time to first meaningful POMWP relief was the earliest assessment time point after the first application of the trial medication at which the patient reported a score of ≥2."|Within 2 h after the first dose of trial medication|TS|||Percentage of participants|||Number
2542254|NCT03003000|Secondary|Number of Patients With a Decrease in POMwp of at Least 30% or 50% Between Baseline and Day 2 (Morning, 2 h After Drug Intake)|Number of patients with a decrease in POMwp of at least 30% or 50% between baseline and Day 2 (morning, 2 h after drug intake.|Baseline and Day 2 (morning, 2 h after drug intake)|TS|||Participants|||Number
2542255|NCT03003000|Secondary|Global Assessment of Efficacy by the Patient at the End of Treatment (Morning of Day 6)|"Global assessment of efficacy by the patient at the end of treatment (morning of Day 6) is presented. The patient/investigator assessed the overall efficacy of the trial treatment on a 4-point verbal rating scale by answering the question: How would you rate the overall effect of the trial medication for relieving back or neck pain? (0 = poor; 1 = fair; 2 = good; 3 = very good)."|At the end of treatment (morning of Day 6)|TS including participants with available data for global assessment of efficacy|||Participants|||Number
2542256|NCT03003000|Secondary|Change in Pressure Algometry Between Baseline and Day 2 (Morning, 2 Hour After Drug Intake)|"Change in pressure algometry between baseline and Day 2 (morning, 2 h after drug intake).~Pressure algometry was determined by the investigator as the pressure value (N/cm2) at a defined trigger point which is located in the area of POMWP. The measurement was performed by using a Somedic Algometer (Somedic AB, Sweden) or an equivalent calibrated and certified device. The pain reaction was determined by placing the algometer on the trigger point, i.e. an area of 1 cm² for which the patient indicated most painful tenderness. The pressure was constantly increased until the patient asked not to increase the pressure anymore. Upon this pain reaction, the corresponding pressure value was documented in the Electronic case report form (eCRF). The trigger point was to be marked with a ball pen to be able to repeat the subsequent assessment at the same position. Change in pressure was calculated as baseline pressure - pressure at Day 2, with a negative result indicating an improvement."|Baseline and Day 2 (morning, 2 h after drug intake)|TS|||newton/centimeter² (N/cm^2)||Standard Error|Least Squares Mean
2542257|NCT03003000|Secondary|The Area Under the Curve (AUC) for the Procedure With the Highest Pain Score at Baseline (POMWP) Between Baseline and Day 6 (Morning) (POM(WP)AUC(120h))|"This is a key secondary endpoint. The area under the curve for pain on movement with regard to the worst procedure between baseline and Day 6 (morning) (POM(WP)AUC(120h).~POM was assessed by the patient at the performance of one standardized, muscle group specific movement and was measured by a numerical rating scale ranging from 0 = 'no pain'to 10 = 'worst pain possible for this condition'. A higher AUC value indicates higher POMwp."|Baseline, Day 1, Day 2, Day 4 and Day 6 (morning)|TS|||Unit on scale||Standard Error|Least Squares Mean
2542258|NCT03003000|Secondary|The Area Under the Curve (AUC) for Pain on Movement (POM) With Regard to the Worst Procedure (POMwp) Between Baseline and Day 4 (Morning) (POMwpAUC72hour (h))|This is a key secondary endpoint. The area under the curve (AUC) for pain on movement (POM) with regard to the worst procedure (POMwp) between baseline and Day 4 (morning), (POMwpAUC72h ). POM was assessed by the patient at the performance of one standardized, muscle group specific movement and was measured by a numerical rating scale ranging from 0 = 'no pain'to 10 = 'worst pain possible for this condition'. A higher AUC value indicates higher POMwp|Baseline, Day 1, Day 2 and Day 4 (morning)|Treated Set (TS): The TS comprised all randomised patients who took at least 1 dose of trial medication.|||Unit on scale||Standard Error|Least Squares Mean
2542259|NCT03003000|Primary|Change in Pain on Movement (POM) With Regard to the Worst Procedure (WP) Between Baseline and Day 2 (Morning, 2 Hours After Drug Intake)|"The change in pain on movement (POM) with regard to the worst procedure (WP), i.e. the procedure with the highest pain score at baseline (POMwp), between baseline (morning of Day 1, pre-dosing) and Day 2 (morning, 2 hour (h) after drug intake).~POM was assessed by the patient at the performance of one standardized, muscle group specific movement and was measured by a numerical rating scale ranging from 0 = 'no pain'to 10 = 'worst pain possible for this condition'.~The procedure resulting in highest POM at baseline (worst procedure, POMWP) was repeated for an individual patient. If 2 or more procedures gave the same highest POM, the patient was asked which of the procedures giving the highest POM scores he/she considered the most unpleasant.~Change in POMwp was calculated as baseline POMwp - POMwp at Day 2 - indicating a reduction in POMwp, where the result is positive."|Baseline and Day 2|Full analysis set (FAS): FAS comprised all patients in the TS who provided a baseline value for POMWP at Visit 1 (before drug intake) and at least 1 POMWP post-treatment value at Visit 1 (Day 1 morning, 2 h after drug intake) and at Visit 2 (Day 2, morning, 2 h after drug intake).|||Unit on scale||Standard Error|Least Squares Mean
2542260|NCT03002818|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-Treatment|SVR12 defined as hepatitis C virus ribonucleic acid (HCV RNA) not detectable 12 weeks after the last actual dose of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (Viekirax®/Exviera®, 3D regimen).|Day 168 (or 12 weeks after the last dose of study drug)|ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets.|||percentage of participants||95% Confidence Interval|Number
2542261|NCT03002818|Secondary|Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: mITT Population|The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.|Baseline, Days 28, 84, 168|ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.|||Spearman correlation coefficient|||Number
2542262|NCT03002818|Secondary|Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: sdITT Population|The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.|Baseline, Days 28, 84, 168|ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.|||Spearman correlation coefficient|||Number
2542263|NCT03002818|Secondary|Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population|The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.|Baseline, Days 28, 84, 168|ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.|||Spearman correlation coefficient|||Number
2542264|NCT03002818|Secondary|Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population|The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.|Baseline, Days 28, 84, 168|ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.|||Spearman correlation coefficient|||Number
2542265|NCT03002818|Secondary|Change From Baseline Over Time in Sleep Efficiency|"Sleep efficiency for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link). Sleep efficiency was defined as the percent of time scored as sleep during the sleep period, from 0% to 100%. Changes were calculated by the formula Baseline minus Day 28, Day 84, or Day 168. Therefore the resulting negative values reflect deterioration and resulting positive values reflect improvement."|Baseline, Days 28, 84, 168|ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.|||percent of time asleep||Standard Deviation|Mean
2542266|NCT03002818|Secondary|Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score|"The FSS is a 9-item questionnaire assessing the functional impact of fatigue during the past two weeks on multiple life domains using scales from 1 (strongly disagree) to 7 (strongly agree). The fatigue score is the mean score of the 9 items, with lower scores indicating less fatigue severity. Clinically significant fatigue is usually defined as score equal or above 4. Changes were calculated by the formula Baseline minus Day 28, Day 84, or Day 168. Therefore the resulting negative values reflect deterioration and resulting positive values reflect improvement."|Baseline, Days 28, 84, 168|ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.|||score on a scale||Standard Deviation|Mean
2542267|NCT03002818|Secondary|Change From Baseline Over Time in Mean Daytime Physical Activity|Mean daytime physical activity for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link), which measures activity via a 3-axis algorithm. For total daytime physical activity, the measured counts of the activity tracker data minus total sleep counts were used as day-counts. Higher day-counts signify more activity.|Baseline, Days 28, 84, 168|ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.|||day-counts||Standard Deviation|Mean
2542280|NCT03002610|Primary|Understanding of the Content of Summary Format|The questions will focus on understanding the benefits and risks of the intervention and the quality of evidence described in the systematic review. In total, there will be 10 open ended questions, and the total score will be the sum of the correct answers (minimum 0, maximum 10). Higher scores would indicate higher understanding.|One month (30 days)||||units on a scale||95% Confidence Interval|Median
2553991|NCT02764775|Primary|Change in Head Holding Active Time From Baseline to 6 Months|Active time in seconds holding head upright|baseline to 6 months|Children ages 3 to 11 years|||Seconds||Standard Deviation|Mean
2542268|NCT03002818|Primary|Change From Baseline at Day 168 in Mean Daytime Physical Activity|Mean daytime physical activity for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link), which measures activity via a 3-axis algorithm. For total daytime physical activity, the measured counts of the activity tracker data minus total sleep counts were used as day-counts. Higher day-counts signify more activity.|Baseline, Day 168|ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point.|||day-counts||Standard Deviation|Mean
2542269|NCT03002753|Primary|Y-BOCS Change Score (Pre to Post Assessment)|German version of the Yale-Brown Obsessive Compulsive Scale (Hand & Büttner-Westphal, 1991). The mininum value is 0, the maximal value is 40. Higher scores indicate a higher symptom severity of obsessive-compulsive disorder.|Difference score resulting from (a) first baseline minus post-treatment (non-waitlist) or (b) first baseline minus second baseline (waitlist). In both cases, there are 2 weeks between the two measurements.|People with obsessive-compulsive disorder|||units on a scale||Standard Deviation|Mean
2542270|NCT03002623|Secondary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 12 months and 13 days||||Participants|||Count of Participants
2542271|NCT03002623|Secondary|Correlation Between Histone Deacetylase 2 (HDAC2) and Survivin Protein Levels in Tumor Tissue With Median Amount of Time Subject Survives Without Disease Progression After Treatment|The amount of time subject survives without disease progression is compared by the protein levels of HDAC2 and surviving in tumor tissue. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions.|At disease progression|This outcome measure was not done. Data was collected but not analyzed because the assessment of HDAC2 and survivin proteins cannot be reliably performed with consistent results.||||||
2542272|NCT03002623|Secondary|Correlation Between Activation of the Phosphoinositide 3-kinase (PI3K)/Protein Kinase B (AKT) and EGFR/RAS/RAF/MEK/ERK Pathways in Tumor Tissue and Median Amount of Time Subject Survives Without Disease Progression After Treatment|The amount of time subject survives without disease progression is compared by the protein levels of PI3K/AKT and epidermal growth factor receptor (EGFR)/rat sarcoma (RAS)/rapidly accelerated fibrosarcoma (RAF)/methyl ethyl ketone (MEK)/extracellular-signal regulated kinase (ERK) in tumor tissue.|At disease progression|This outcome measure was not done. Data was collected but no samples were analyzed because the experiment was not technically successful due to inconclusive results from immunohistochemistry (study of protein levels in tumor tissue) analysis of P13K/AKT and EGFR/RAS/RAF/MEK/ERK proteins.||||||
2542273|NCT03002623|Secondary|Correlation Between Mutation Status of Tumor and Median Amount of Time Subject Survives Without Disease Progression After Treatment|The amount of time subject survives without disease progression is compared by patient tumor mutation status.|At disease progression|This outcome measure was not done. Data was collected but the correlation between mutation status of tumor and progression-free survival was not performed because of only BRAF V600E and the loss of tumor protein 53 (TP53) heterozygosity were found on a single patient each. Since only 1 mutant was found for each, no analysis was done.||||||
2542274|NCT03002623|Secondary|Median Amount of Time Subject Survives After Therapy|Time in days from the initiation of treatment until death estimated by the Kaplan-Meier method.|Approximately 12 months|Participants are grouped together because of a small sample size and not enough power to compare the difference between two groups. No statistical analysis to be done.|||Days||95% Confidence Interval|Median
2542275|NCT03002623|Secondary|Median Amount of Time Subject Survives Without Disease Progression After Treatment|Time in days from initiation of treatment until tumor grows more than 20%. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions.|Approximately 6 months|One participant was non-evaluable (withdrew consent).|||Days||Full Range|Median
2542276|NCT03002623|Primary|Number of Participants With a Clinical Response (Complete Response (CR) + Partial Response (PR)) Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|Clinical response, defined as a complete response + partial response (CR+PR) to CUDC-907 treatment, was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.|Approximately 6 months||||Participants|||Count of Participants
2542277|NCT03002610|Other Pre-specified|Health Numeracy|This section will use 6-item General health numeracy test (Osborne et al., 2013) in order to determine how much our participants understand the basic health instructions regarding numeracy dimension. For each correct answer, the participants receive one point and the total score is the sum of all correct answers.|One month (30 days)||||units on a scale||Inter-Quartile Range|Median
2542278|NCT03002610|Secondary|User Friendliness|This section of the survey will have 5 questions concerning how easy it was for the participant to find relevant information, measured by a 10-point Likert type scale where the answer 1 means I do not agree at all and 10 means I fully agree. The total score is the sum of scores on all the answers (minimum 5, maximum 50). Higher scores would indicate greater, or more positive user friendliness, meaning that participants consider that format as easier to find relevant information.|One month (30 days)||||units on a scale||95% Confidence Interval|Median
2542281|NCT03002454|Primary|Number of Participants Analyzed for Diagnostic Efficacy of Technetium (99mTc) Medronate Injection Prepared With 99mTc Derived From Neutron-activation Produced 99Mo Imaging Sensitivity Versus 99mTc Derived From Fission-produced 99Mo Imaging Sensitivity.|All enrolled patients were re-imaged 3 to 28 days post a standard of care fission derived 99Mo bone scan using neutron-activation produced 99Mo as the investigational product. Per protocol dosage, time factors, injection site and imaging camera were matched. Resulting image sets (fission and neutron-activation) were analyzed visually for concordant biodistribution.|60 days|Each participant (4) acted as their own control to reduce variance. Paired image sets were analyzed visually for concordant biodistribution between the 99mTc Medronate Injection prepared with 99mTc derived from Neutron-activation produced 99Mo versus 99mTc Medronate Injection derived from Fission-produced 99Mo referenced as the baseline standard.|||Participants|||Count of Participants
2542282|NCT03002194|Secondary|General Aesthetic Improvement Scale (GAIS)|Subject to assess their general improvement in appearance at 7 and 20 weeks post-intervention using a 7 category scale: 3 - very much improved; 2 - much improved; 1 - improved; 0 - no change; -1 - worse; -2 - much worse and -3 very much worse. The higher the positive score, the more the subject feels their appearance has changed for the better.|7 weeks and 20 weeks post study treatments.||||score on a scale||Standard Deviation|Mean
2542283|NCT03002194|Secondary|Improvement in Subject Satisfaction With Facial Skin Laxity Compared to Baseline as Measured by the 5-point Likert Satisfaction Scale|Subject will assign a score that best represents the level of satisfaction they have in their appearance as a result of the study treatment. The scale reports five categories - 4 - very satisfied; 3 - satisfied; 2 - having no opinion; 1 - unsatisfied and 0 - very unsatisfied. The higher the score, the more satisfaction with the treatment that a subject reports.|7 weeks and 20 weeks post study treatments||||score on a scale||Standard Deviation|Mean
2542284|NCT03002194|Primary|Change in Facial Skin Elasticity|A Cutometer® will be used to measure the change in gross elasticity (R2) of the facial skin as calculated by Ua/Uf which is a ratio of maximum recovery (Ua) and skin distensibility (Uf). The value is expressed as a percentage, the closer the value is to 1 (100%), the more elastic the skin.|20 weeks after the last study treatment||||ratio||Standard Deviation|Mean
2542285|NCT03002012|Other Pre-specified|Adherence to Study Drug|Participants' percent adherence to study drug regiment by pharmacy medication counts, representing the percent of the total prescribed medication taken by participants.|12 weeks||||Percent of total prescribed medication t||Inter-Quartile Range|Median
2542286|NCT03002012|Secondary|Prevalence of Depression by Patient Health Questionnaire (PHQ-9) Over Time|Prevalence of depression by Patient Health Questionnaire (PHQ-9) over 6 months as measured at baseline, 4 weeks, 8 weeks, and 12 weeks. The PHQ-9 is a 9-item instrument for screening, diagnosing, monitoring, and measuring the severity of depression. Items are rated on a scale from 0 (not at all) to 3 (nearly every day). Total score is a sum of 9 item scores (Range 0-27). Greater scores indicate greater depressive symptoms. PHQ-9 scores of: 0-4 Minimal/No depression; 5-9 Mild depression; 10-14 Moderate depression; 15-19 Moderate severe depression; 20-27 Severe depression. This endpoint reports the median (interquartile range) of the PHQ-9 scores over time.|12 weeks||||score on a scale||Inter-Quartile Range|Median
2542287|NCT03002012|Secondary|All-Cause Premature Study Drug/Placebo Discontinuation|Number of participants whose study drug/placebo use was halted prematurely due to any cause through 6 months|6 months||||Participants|||Count of Participants
2542288|NCT03002012|Secondary|Number of Laboratory Grade 3-5 Adverse Events|Number of Laboratory Grade 3-5 Adverse Events through 6 months as per the Division of AIDS (DAIDS) grading scale|6 months||||number of grade 3-5 adverse events|||Number
2542289|NCT03002012|Secondary|Number of Clinical Adverse Events (Grade 3-5)|Number of Clinical Adverse Events by Division of AIDS (DAIDS) Scale for Grade 3-5 events through 6 months|6 months||||number of grade 3-5 adverse events|||Number
2542290|NCT03002012|Secondary|Cumulative Incidence of Symptomatic Cryptococcal Meningoencephalitis|Cumulative incidence of symptomatic cryptococcal meningoencephalitis through 6 months|6 months||||meningitis events|||Number
2542291|NCT03002012|Secondary|6-month Survival|Survival through 6 months|6 months||||Participants|||Count of Participants
2542292|NCT03002012|Primary|6 Month Meningitis-free Survival|"Cryptococcal meningitis free survival with retention-in-care through 6 months~Those who die of any cause are failures~Those developing symptomatic cryptococcal meningitis are failures~Those lost to follow up and unable to be tracked are considered failures"|6 months||||Participants|||Count of Participants
2542293|NCT03001778|Primary|System Usability Scale (SUS)|"Ten likert-type questions assessing user-friendliness of technology. Each question has five answer options that range from Strongly Agree to Strongly Disagree. Scores range from 0-100. A score of 68 or above is considered above average. All scores averaged."|After 1 hour usability session||||units on a scale||Standard Deviation|Mean
2542294|NCT03001674|Primary|Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work.|We will be measuring left ventricular stroke work using a conductance catheter before and immediately after activation of an intra-aortic balloon pump (IABP). Left ventricular stroke work is quantified as the product of left ventricular pressure and volume. Conductance catheters are the primary method available for clinical measurement of left ventricular volume and pressure.|24 hours||||mmHg-mL||Standard Deviation|Mean
2542295|NCT03001557|Other Pre-specified|Change From Baseline in the Sleep Disorders Inventory (SDI) Score at Day 29|The SDI was an expanded version of one item of the NPI. It described the frequency, severity, and caregiver burden of sleep-disturbed behaviors during a period prior to its administration. The SDI consisted of the 7 sub questions relating to sleep from the NPI sleep disturbance item. Each of the sub questions was a separate question with frequency, severity, and caregiver distress rated by the caregiver with respect to the patient-participant for the 2 weeks prior to the visit. The SDI score was derived as the product of the average of the frequency ratings and the average of the severity ratings (range: 0-12 [worst]).|Baseline, Day 29|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||score on a scale||Standard Deviation|Mean
2542349|NCT03001453|Primary|Time to Ambulation More Than 20 Feet (in Hours)|The length of time (in hours) until the patient first ambulates more than 20 feet from the time of surgery will be recorded.|from time of surgery until patient first ambulates more than 20 feet or 72 hours post-surgery or patient discharge, whichever comes first||||hours||Standard Deviation|Mean
2542296|NCT03001557|Other Pre-specified|Change From Baseline in the Neuropsychiatric Inventory (NPI-10) Total Score at Day 29|The NPI-10 assessed a wide range of behaviors seen in dementia for both frequency and severity. It is a 10 item questionnaire with the following domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/liability and aberrant motor behavior. The total score was summarized and analyzed. This scale was administered with the caregiver as proxy for the participant. The total score was a sum of the 10 domains, where the score of each domain was calculated as frequency (scale: 1=occasionally to 4=very frequently) * Severity (scale: 1=Mild to 3=Severe). Each domain has a maximum score of 12 and all domains were equally weighted for total score, thus the range for the total score is 0 to 120 with 0 being completely healthy to 120 which is the worse score participant could get.|Baseline, Day 29|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||score on a scale||Standard Deviation|Mean
2542297|NCT03001557|Other Pre-specified|Number of Participants in Each Category With Clinician's Global Impression of Change-Irregular Sleep-Wake Rhythm Disorder (CGIC-ISWRD) Global Score at Day 29|The CGIC-ISWRD scale is a validated categorical measure of change in the participant's clinical condition between baseline and follow-up visits. It relies on both direct examination of the participant and an interview of the informant. The instrument consisted of 3 parts: a guided baseline interview administered to the participant and an informant, a follow-up interview administered to the participant and an informant, and a clinician's rating review. The baseline interview served as a reference for future ratings. During the baseline interview, the rater evaluated participant regarding domains of (1) sleep and wake symptoms; (2) mood and behavioral symptoms; (3) attention/arousal; and (4) social functioning. In the follow-up interview, a 7-pointscale was used, from 1 = marked improvement, 4 = no change, to 7 = marked worsening, to score each of the 4 domains and to provide a global score (1 [marked improvement] to 7 [marked worsening]).|Day 29|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement.|||Participants|||Count of Participants
2542298|NCT03001557|Other Pre-specified|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||First dose of study drug (Baseline) up to 14 days after last dose of study drug (up to 43 days)|The safety analysis set included the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose safety assessment.|||Participants|||Count of Participants
2542299|NCT03001557|Primary|Change From Baseline in RA Over Week 4 of Treatment|RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.|Baseline, Week 4|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||ratio||Standard Deviation|Mean
2542300|NCT03001557|Primary|Change From Baseline in RA Over Week 3 of Treatment|RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.|Baseline, Week 3|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||ratio||Standard Deviation|Mean
2542301|NCT03001557|Primary|Change From Baseline in RA Over Week 2 of Treatment|RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.|Baseline, Week 2|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||ratio||Standard Deviation|Mean
2542302|NCT03001557|Primary|Change From Baseline in Relative Amplitude in the Rest-activity Rhythm (RA) Over Week 1 of Treatment|RA was relative amplitude of the rest-activity rhythm calculated as the difference between M10 and L5 divided by M10 plus L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. RA was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.|Baseline, Week 1|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||ratio||Standard Deviation|Mean
2542912|NCT02989727|Primary|Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)|Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.|Two weeks||||Participants|||Count of Participants
2542303|NCT03001557|Primary|Change From Baseline in AMP Over Week 4 of Treatment|AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.|Baseline, Week 4|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||activity count||Standard Deviation|Mean
2542304|NCT03001557|Primary|Change From Baseline in AMP Over Week 3 of Treatment|AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.|Baseline, Week 3|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||activity count||Standard Deviation|Mean
2542305|NCT03001557|Primary|Change From Baseline in AMP Over Week 2 of Treatment|AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.|Baseline, Week 2|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||activity count||Standard Deviation|Mean
2542306|NCT03001557|Primary|Change From Baseline in Amplitude of the Rest-activity Rhythm (AMP) Over Week 1 of Treatment|AMP was amplitude of rest-activity rhythm calculated as the difference between M10 and L5. L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. AMP was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.|Baseline, Week 1|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||activity count||Standard Deviation|Mean
2542307|NCT03001557|Primary|Change From Baseline in the Average Activity Count During the M10 Per 24-Hour Period Over Week 4 of Treatment|M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.|Baseline, Week 4|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||activity count||Standard Deviation|Mean
2542308|NCT03001557|Primary|Change From Baseline in the Average Activity Count During the M10 Per 24-Hour Period Over Week 3 of Treatment|M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.|Baseline, Week 3|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||activity count||Standard Deviation|Mean
2542309|NCT03001557|Primary|Change From Baseline in the Average Activity Count During the M10 Per 24-Hour Period Over Week 2 of Treatment|M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.|Baseline, Week 2|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||activity count||Standard Deviation|Mean
2542350|NCT03001453|Primary|Change in Patient-reported Visual Analog Scale (VAS) Pain Intensity Score|Patient-reported VAS pain intensity score (0 = no pain, 10 = worst pain possible) will be collected. Mean VAS scores for the 72-hour period were calculated using the cohort's reported average pain scores at each 12-hour interval.|72 hours post-operation, divided into six 12-hour periods||||units on a scale||Standard Deviation|Mean
2542832|NCT02991599|Secondary|Occurrence of Adverse Events After Vaccination|Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B vaccine|Within 7 days after the vaccination, at Month 0, 1, and 6|196 patients were enrolled and randomized,195 patients received the first dose, 1 patients declined in IM60 group.|||Participants|||Count of Participants
2542310|NCT03001557|Primary|Change From Baseline in the Average Activity Count During the Most Active 10-hour Period (M10) Per 24-Hour Period Over Week 1 of Treatment|M10 was defined as the average activity during the most active 10-hour period per 24-hour period with low levels indicating inactivity. M10 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.|Baseline, Week 1|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||activity count||Standard Deviation|Mean
2542311|NCT03001557|Primary|Change From Baseline in Average Activity Counts Across L5 Per 24-Hour Period Over Week 4 of Treatment|L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.|Baseline, Week 4|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||activity count||Standard Deviation|Mean
2542312|NCT03001557|Primary|Change From Baseline in Average Activity Counts Across L5 Per 24-Hour Period Over Week 3 of Treatment|L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.|Baseline, Week 3|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||activity count||Standard Deviation|Mean
2542313|NCT03001557|Primary|Change From Baseline in Average Activity Counts Across L5 Per 24-Hour Period Over Week 2 of Treatment|L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.|Baseline, Week 2|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||activity count||Standard Deviation|Mean
2542314|NCT03001557|Primary|Change From Baseline in Average Activity Counts Across Least Active 5-hour Period (L5) Per 24-Hour Period Over Week 1 of Treatment|L5 was defined as the average activity across the least active 5-hour period per 24-hour period, with high values indicating restlessness. This value provides an indication of how restful (inactive) and regular the sleep periods are. L5 was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.|Baseline, Week 1|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||activity count||Standard Deviation|Mean
2542315|NCT03001557|Primary|Change From Baseline in Mean IS Over Week 4 of Treatment|IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.|Baseline, Week 4|FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||ratio||Standard Deviation|Mean
2542316|NCT03001557|Primary|Change From Baseline in Mean IS Over Week 3 of Treatment|IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.|Baseline, Week 3|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||ratio||Standard Deviation|Mean
2542317|NCT03001557|Primary|Change From Baseline in Mean IS Over Week 2 of Treatment|IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.|Baseline, Week 2|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||ratio||Standard Deviation|Mean
2542318|NCT03001557|Primary|Change From Baseline in Mean Interdaily Stability (IS) Over Week 1 of Treatment|IS gives an indication of the stability of the sleep-wake rhythm across days, and varies from zero (low stability) to 1 (high stability). IS was derived by the ratio between the variance of the average 24-hour pattern around the mean and the overall variance. Higher values indicated stable rhythm. IS was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.|Baseline, Week 1|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||ratio||Standard Deviation|Mean
2542319|NCT03001557|Primary|Change From Baseline in Mean Intradaily Variability Over Week 4 of Treatment|Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.|Baseline, Week 4|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||ratio||Standard Deviation|Mean
2542320|NCT03001557|Primary|Change From Baseline in Mean Intradaily Variability Over Week 3 of Treatment|Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.|Baseline, Week 3|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||ratio||Standard Deviation|Mean
2542321|NCT03001557|Primary|Change From Baseline in Mean Intradaily Variability Over Week 2 of Treatment|Intradaily variability gives an indication of ISWRD by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.|Baseline, Week 2|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||ratio||Standard Deviation|Mean
2542322|NCT03001557|Primary|Change From Baseline in Mean Intradaily Variability Over Week 1 of Treatment|Intradaily variability gives an indication of irregular sleep-wake rhythm disorder (ISWRD) by quantifying the number and strength of transitions between rest and activity bouts, derived by the ratio of the mean squares of the difference between all successive hours (first derivative) and the mean squares around the grand mean (overall variance). The variable has a theoretical range of 0 to 2, with higher values indicating higher fragmentation. Intradaily variability was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.|Baseline, Week 1|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||ratio||Standard Deviation|Mean
2542323|NCT03001557|Primary|Change From Baseline in the aMeanDurSB During Week 4 of Treatment|aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.|Baseline, Week 4|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||minutes||Standard Deviation|Mean
2542324|NCT03001557|Primary|Change From Baseline in the aMeanDurSB During Week 3 of Treatment|aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.|Baseline, Week 3|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||minutes||Standard Deviation|Mean
2542913|NCT02989727|Primary|Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)|Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.|Three weeks||||Participants|||Count of Participants
2542325|NCT03001557|Primary|Change From Baseline in the aMeanDurSB During Week 2 of Treatment|aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.|Baseline, Week 2|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||minutes||Standard Deviation|Mean
2542326|NCT03001557|Primary|Change From Baseline in the Mean Duration of Sleep Bouts (aMeanDurSB) During Week 1 of Treatment|aMeanDurSB was defined as an average duration of all sleep bouts that occurred during the 16 hours outside of the predefined nocturnal sleep period. The sleep bout was defined as the continuous sleep of 10 minutes or longer. lower values were better. aMeanDurSB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.|Baseline, Week 1|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||minutes||Standard Deviation|Mean
2542327|NCT03001557|Primary|Change From Baseline in Mean WFI During Week 4 of Treatment|The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of <=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100 percent (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.|Baseline, Week 4|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||percentage of immobile bouts||Standard Deviation|Mean
2542328|NCT03001557|Primary|Change From Baseline in Mean WFI During Week 3 of Treatment|The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of <=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100 percent (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.|Baseline, Week 3|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||percentage of immobile bouts||Standard Deviation|Mean
2542329|NCT03001557|Primary|Change From Baseline in Mean WFI During Week 2 of Treatment|The WFI were calculated as the sum of an II and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of <=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100 percent (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.|Baseline, Week 2|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||percentage of immobile bouts||Standard Deviation|Mean
2542330|NCT03001557|Primary|Change From Baseline in Mean Wake Fragmentation Index (WFI) During Week 1 of Treatment|The WFI were calculated as the sum of an immobility index (II) and a FI during the logged wake period. The II was equal to the epochs of immobility per the 16 hours outside of the defined sleep period multiplied by 100. The FI was equal to the number of <=1-minute periods of mobility/total number of periods of mobility the 16 hours outside of the defined sleep period multiplied by 100. Value ranges from 0-100 percent (lower values were better). The WFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.|Baseline, Week 1|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||percentage of immobile bouts||Standard Deviation|Mean
2542331|NCT03001557|Primary|Change From Baseline in Mean aWE During Week 4 of Treatment|aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.|Baseline, Week 4|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||percentage of wake time||Standard Deviation|Mean
2542914|NCT02989727|Primary|Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)|Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.|Four weeks||||Participants|||Count of Participants
2542332|NCT03001557|Primary|Change From Baseline in Mean aWE During Week 3 of Treatment|aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.|Baseline, Week 3|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||percentage of wake time||Standard Deviation|Mean
2542333|NCT03001557|Primary|Change From Baseline in Mean aWE During Week 2 of Treatment|aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.|Baseline, Week 2|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||percentage of wake time||Standard Deviation|Mean
2542334|NCT03001557|Primary|Change From Baseline in Mean Actigraphy Wake Efficiency (aWE) During Week 1 of Treatment|aWE was defined as the percentage of time spent awake in bed during defined wake period, as measured by actigraphy. Wake efficiency was calculated as the total duration of wake epochs during 16 hours outside of the predefined sleep period divided by 16 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.|Baseline, Week 1|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||percentage of wake time||Standard Deviation|Mean
2542335|NCT03001557|Primary|Change From Baseline in the aMeanDurWB During Week 4 of Treatment|aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.|Baseline, Week 4|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||minutes||Standard Deviation|Mean
2542336|NCT03001557|Primary|Change From Baseline in the aMeanDurWB During Week 3 of Treatment|aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.|Baseline, Week 3|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||minutes||Standard Deviation|Mean
2542337|NCT03001557|Primary|Change From Baseline in the aMeanDurWB During Week 2 of Treatment|aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.|Baseline, Week 2|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||minutes||Standard Deviation|Mean
2542338|NCT03001557|Primary|Change From Baseline in the Mean Duration of Wake Bouts (aMeanDurWB) During Week 1 of Treatment|aMeanDurWB was defined as an average duration of all wake bouts that occurred during the defined nocturnal predefined sleep period. The wake bout was defined as continuous wake of 10 minutes or longer. Lower values were better. aMeanDurWB was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.|Baseline, Week 1|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||minutes||Standard Deviation|Mean
2542339|NCT03001557|Primary|Change From Baseline in Mean SFI During Week 4 of Treatment|The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number <=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100 percent (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.|Baseline, Week 4|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||percentage of immobile bouts||Standard Deviation|Mean
2542340|NCT03001557|Primary|Change From Baseline in Mean SFI During Week 3 of Treatment|The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number <=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100 percent (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.|Baseline, Week 3|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||percentage of immobile bouts||Standard Deviation|Mean
2542341|NCT03001557|Primary|Change From Baseline in Mean SFI During Week 2 of Treatment|The SFI was defined as the sum of a MI and a FI during the logged sleep period. The MI was equal to the epochs of wake per TBI multiplied by 100. The FI was equal to the number <=1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100 percent (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.|Baseline, Week 2|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||percentage of immobile bouts||Standard Deviation|Mean
2542342|NCT03001557|Primary|Change From Baseline in Mean Sleep Fragmentation Index (SFI) During Week 1 of Treatment|The SFI was defined as the sum of a movement index (MI) and a fragmentation index (FI) during the logged sleep period. The MI was equal to the epochs of wake per time in bed (TBI) multiplied by 100. The FI was equal to the number of less than or equal to (<=) 1-minute periods of immobility/total number of periods of immobility of all durations during the defined nocturnal sleep period multiplied by 100. Value ranges from 0-100 percent (lower values were better). SFI was determined by Actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.|Baseline, Week 1|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||percentage of immobile bouts||Standard Deviation|Mean
2542343|NCT03001557|Primary|Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 4 of Treatment|aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average last 7 nights of treatment was reported.|Baseline, Week 4|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||percentage of sleep time||Standard Deviation|Mean
2542344|NCT03001557|Primary|Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 3 of Treatment|aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average third 7 nights of treatment was reported.|Baseline, Week 3|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||percentage of sleep time||Standard Deviation|Mean
2542345|NCT03001557|Primary|Change From Baseline in Mean aSE With Lemborexant Compared to Placebo During Week 2 of Treatment|aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average second 7 nights of treatment was reported.|Baseline, Week 2|The FAS included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||percentage of sleep time||Standard Deviation|Mean
2542346|NCT03001557|Primary|Change From Baseline in Mean Actigraphy Sleep Efficiency (aSE) With Lemborexant Compared to Placebo During Week 1 of Treatment|aSE was defined as the percentage of time spent in bed nocturnal sleeping, as measured by actigraphy. Sleep efficiency was calculated as the total duration of sleep epochs during the predefined 8-hour nocturnal sleep period divided by 8 hours and multiplied by 100. Higher values were better. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to monitor degree and intensity of movements while the device was being worn. Change from baseline to average first 7 nights of treatment was reported.|Baseline, Week 1|The full analysis set (FAS) included group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement. Participants who were evaluable for this measure at given time point were included for the assessment.|||percentage of sleep time||Standard Deviation|Mean
2542347|NCT03001453|Primary|Number of Patients That Experienced a Fall||72 hours postoperation||||participants|||Number
2542348|NCT03001453|Primary|Length of Stay (LOS, in Days)||From time of surgery until patient is discharged, an average of 1.5 days.||||Hours||Standard Deviation|Mean
2542352|NCT03001258|Primary|Screening Accuracy|"The outcome was considered as accurate and coded as 1 if the screening result agreed with the gold standard. That is, if the screening result is positive for presbyopia and the refractionist also reported it as positive or the screening result is negative and the refractionist also reported as negative."|The study duration was for 5 months, however, data was collected by organizing the eye camps over 2 weeks period||||percentage of cases||95% Confidence Interval|Number
2542353|NCT03001219|Secondary|Synovial Fluid RO7123520 Concentration||Pre-dose (0 hour) on Days 1, 84|All enrolled participants were included in the PK population. No PK analysis was performed due to an insufficient number of available participant samples for processing.||||||
2542354|NCT03001219|Secondary|Serum RO7123520 Concentration||Pre-dose (0 hour), 1 hour post infusion (duration of infusion: approximately 1 hour) on Days 1, 14, 28, 56; Pre-dose (0 hour) on Days 84, 112|All enrolled participants were included in the PK population. No PK analysis was performed due to an insufficient number of available participant samples for processing.||||||
2542355|NCT03001219|Secondary|Change From Baseline in the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12|"The HAQ-DI is a 20-item, validated questionnaire used to assess difficulty in performing activities of daily living. The questionnaire assesses eight domains of physical functioning: Dressing and Grooming (2 items), Hygiene (3 items), Arising (2 items), Reach (2 items), Eating (3 items), Grip (3 items), Walking (2 items), Common Daily Activities (3 items). The questions assess usual abilities ranging from 0 without any difficulty to 3 unable to do. A lower HAQ-DI score indicates better quality of life. Subscale scores are combined and the mean value is reported for each arm per timepoint."|Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)|The efficacy population included all randomized participants.|||Units on a scale||Standard Deviation|Mean
2542356|NCT03001219|Secondary|Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 12|The SDAI consists of 5 parameters used to assess RA disease activity: 28-joint count assessments of tenderness and swelling, participant and investigator global assessments, and CRP levels. A composite score is produced, with remission defined as an SDAI of <3.3, low disease activity as ≤11, moderate disease activity as ≤26 and high disease activity as >26.|Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)|The efficacy population included all randomized participants.|||Scores on a scale||Standard Deviation|Mean
2542357|NCT03001219|Secondary|Percentage of Participants Achieving ACR70 Response at Week 12|The ACR70 is a composite measure defined as both improvement of 70% in the number of tender and number of swollen joints, and a 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). The ACR is reported as percent improvement at discrete time points.|Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)|The efficacy population included all randomized participants.|||Percent||90% Confidence Interval|Number
2542358|NCT03001219|Secondary|Percentage of Participants Achieving ACR20 Response at Week 12|The ACR20 is a composite measure defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). The ACR is reported as percent improvement at discrete time points.|Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)|The efficacy population included all randomized participants.|||Percent||90% Confidence Interval|Number
2542359|NCT03001219|Secondary|Percentage of Participants Achieving CDAI Remission at Week 12|The CDAI for Rheumatoid Arthritis (RA) assesses the severity of the disease using clinical data. It consists of the Patient Global disease Activity (PGA) estimate and the Evaluator Global disease Activity (EGA) estimate, each of which represent assessments of disease activity on a scale of 1-10, with 10 being maximum activity. CDAI remission is defined as a score of less than or equal to 2.8.|Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)|The efficacy population included all randomized participants.|||Percent|||Number
2542360|NCT03001219|Secondary|Percentage of Participants Achieving DAS28 Remission at Week 12|"The DAS28 is a combined index for measuring disease activity in RA; the 28 refers to the number of joints included in the assessment. The index includes swollen and tender joint counts, acute phase response, and general arthritis disease activity status. An overall disease activity score of 5.1 or greater implies active disease, less than 3.2 implies low disease activity, and less that 2.6 implies disease remission."|Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)|The efficacy population included all randomized participants.|||Percent|||Number
2542361|NCT03001219|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) at Week 12|"The DAS28 is a combined index for measuring disease activity in RA; the 28 refers to the number of joints included in the assessment. The index includes swollen and tender joint counts, acute phase response, and general arthritis disease activity status. An overall disease activity score of 5.1 or greater implies active disease, less than 3.2 implies low disease activity, and less that 2.6 implies disease remission."|Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)|The efficacy population included all randomized participants.|||Units on a scale||Standard Deviation|Mean
2542362|NCT03001219|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12|The CDAI for Rheumatoid Arthritis (RA) assesses the severity of the disease using clinical data. It consists of the Patient Global disease Activity (PGA) estimate and the Evaluator Global disease Activity (EGA) estimate, each of which represent assessments of disease activity on a scale of 1-10, with 10 being maximum activity.|Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)|The efficacy population included all randomized participants.|||Units on a scale||Standard Deviation|Mean
2542363|NCT03001219|Primary|Change From Baseline in Bone Mineral Density Lumbar Spine L1-L4 as Assessed by Dual Energy X-ray Absorptiometry (DEXA) Scans||Baseline, Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)|The safety population included all participants who received at least one dose of study medication.|||g/cm^2||Standard Deviation|Mean
2542364|NCT03001219|Primary|Percentage of Participants With Anti-Drug Antibodies||Baseline|This outcome measure only includes the immunogenicity population, which was the PoC 810 mg dose group. These participants had at least 1 pre-dose ADA assessment.|||Percent|||Number
2542365|NCT03001219|Primary|Proportion of Participants Achieving an American College of Rheumatology (ACR) 50 Response at Week 12|The ACR50 is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). The ACR is reported as percent improvement at discrete time points.|Week 12 of PoC and Week 12 of Extension Period Analysis (overall study week 24)|The efficacy population included all randomized participants. Overall study = up to 32 weeks per participant. PoC = Weeks 1-12, Extension Period Analysis = Weeks 1-20 (overall study weeks 13-32)|||Percent||90% Confidence Interval|Number
2542366|NCT03001219|Primary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline to last participant last visit (approximately 2 years)|The safety population included all participants who received at least one dose of study medication.|||Percentage of Participants|||Number
2542367|NCT03001076|Other Pre-specified|Absolute Change From Baseline to Weeks 4, 8, and 12 in LDL-C|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for LDL-C. Baseline was defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Absolute change from baseline was calculated as: LDL-C value at Week 4, 8, or 12 minus Baseline value.|Week 4, Week 8 and Week 12|Full Analysis Set. Only participants with available data were analyzed.|||milligrams per deciliter (mg/dL)||Standard Deviation|Geometric Mean
2542368|NCT03001076|Other Pre-specified|Percent Change From Baseline to Weeks 4 and 8 in HDL-C|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for HDL-C. Baseline was defined as the mean of the HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: [(HDL-C value at Week 4 or 8 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Percent change from Baseline in HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate.|Week 4 and Week 8|Full Analysis Set. Only participants with available data were analyzed.|||Percent change||Standard Error|Least Squares Mean
2542369|NCT03001076|Other Pre-specified|Percent Change From Baseline to Weeks 4 and 8 in TGs|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for TGs. Baseline was defined as the mean of the TGs values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: [(TGs value at Week 4 or 8 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Percent change from Baseline in TGs was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate.|Week 4 and Week 8|Full Analysis Set. Only participants with available data were analyzed.|||Percent change||Standard Error|Least Squares Mean
2542370|NCT03001076|Other Pre-specified|Percent Change From Baseline to Weeks 4 and 8 in TC|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the mean of the TC values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: [(TC value at Week 4 or 8 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Percent change from Baseline in TC was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate.|Week 4 and Week 8|Full Analysis Set. Only participants with available data were analyzed.|||Percent change||Standard Error|Least Squares Mean
2542371|NCT03001076|Other Pre-specified|Percent Change From Baseline to Weeks 4 and 8 in Non-HDL-C|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for Non-HDL-C. Baseline was defined as the mean of the Non-HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: [(Non-HDL-C value at Week 4 or 8 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Percent change from Baseline in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate.|Week 4 and Week 8|Full Analysis Set. Only participants with available data were analyzed.|||Percent change||Standard Error|Least Squares Mean
2542372|NCT03001076|Other Pre-specified|Percent Change From Baseline to Weeks 4 and 8 in LDL-C|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: [(LDL-C value at Week 4 or 8 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Percent change from Baseline in LDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate.|Week 4 and Week 8|Full Analysis Set. Only participants with available data were analyzed.|||Percent change||Standard Error|Least Squares Mean
2542373|NCT03001076|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|TEAEs, defined as an adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and prior to the last dose of double-blind study drug + 30 days, were collected and reported.|Up to approximately 16 weeks|Safety Analysis Set: all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group that they actually received, regardless of their randomized treatment.|||Participants|||Number
2542384|NCT03000686|Secondary|Clearance for GSK2586881-Part 1|Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period|PK1 Population|||Liters per hour per kilogram||Geometric Coefficient of Variation|Geometric Mean
2542374|NCT03001076|Secondary|Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C)|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for HDL-C. Baseline was defined as the mean of the HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: [(HDL-C value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Percent change from Baseline in HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate.|Week 12|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Standard Error|Least Squares Mean
2542375|NCT03001076|Secondary|Percent Change From Baseline to Week 12 in Triglycerides (TGs)|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TGs. Baseline was defined as the mean of the TGs values from the last two non-missing values on or prior to D 1. Percent change from baseline was calculated as: [(TGs value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Percent change from Baseline in TGs was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate.|Week 12|Full Analysis Set. Only participants with available data were analyzed.|||Percent change||Standard Error|Least Squares Mean
2542376|NCT03001076|Secondary|Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for hsCRP. Baseline was defined as the last non-missing value on or prior to Day 1. Percent change from baseline was calculated as: [(hsCRP value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100.|Week 12|Full Analysis Set. Only participants with available data were analyzed.|||Percent change||Inter-Quartile Range|Median
2542377|NCT03001076|Secondary|Percent Change From Baseline to Week 12 in Apolipoprotein B (apoB)|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for apoB. Baseline was defined as the last non-missing value on or prior to Day 1. Percent change from baseline was calculated as: [(apoB value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Percent change from Baseline in apoB was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. In the ANCOVA model, missing apoB data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.|Week 12|Full Analysis Set|||Percent change||Standard Error|Least Squares Mean
2542378|NCT03001076|Secondary|Percent Change From Baseline to Week 12 in Total Cholesterol (TC)|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for TC. Baseline was defined as the mean of the TC values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: ([TC value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. Percent change from Baseline in TC was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. In the ANCOVA model, missing TC data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.|Week 12|Full Analysis Set|||Percent change||Standard Error|Least Squares Mean
2542379|NCT03001076|Secondary|Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analysed for non-HDL-C. Baseline was defined as the mean of the non-HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: ([non-HDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. Percent change from Baseline in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. In the ANCOVA model, missing non-HDL-C data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.|Week 12|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
2542380|NCT03001076|Primary|Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C)|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Percent change from baseline was calculated as: ([LDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. Bempedoic Acid = BA. Percent change from Baseline in LDL-C was analyzed using an analysis of covariance (ANCOVA) model with percent change from Baseline as the dependent variable, treatment as a fixed effects and Baseline as a covariate. In the ANCOVA model, missing LDL-C data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.|Week 12|Full Analysis Set: all randomized participants|||percent change||Standard Error|Least Squares Mean
2542381|NCT03000686|Secondary|Volume of Distribution for GSK2586881-Part 2|Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period|PK2 Population|||Liters per kilogram||Geometric Coefficient of Variation|Geometric Mean
2542382|NCT03000686|Secondary|Volume of Distribution for GSK2586881-Part 1|Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period|PK1 Population|||Liters per kilogram||Geometric Coefficient of Variation|Geometric Mean
2542383|NCT03000686|Secondary|Clearance for GSK2586881-Part 2|Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period|PK2 Population|||Liters per hour per kilogram||Geometric Coefficient of Variation|Geometric Mean
2542385|NCT03000686|Secondary|T1/2 of GSK2586881-Part 2|Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period|PK2 Population|||Hours||Geometric Coefficient of Variation|Geometric Mean
2542386|NCT03000686|Secondary|Apparent Terminal Half-life (T1/2) of GSK2586881-Part 1|Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period|PK1 Population|||Hours||Geometric Coefficient of Variation|Geometric Mean
2542387|NCT03000686|Secondary|Tmax of GSK2586881-Part 2|Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period|PK2 Population|||Hours||Full Range|Median
2542388|NCT03000686|Secondary|Time to Reach Cmax (Tmax) of GSK2586881-Part 1|Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period|PK1 Population|||Hours||Full Range|Median
2542389|NCT03000686|Secondary|Cmax of GSK2586881-Part 2|Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period|PK2 Population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2542390|NCT03000686|Secondary|Maximum Observed Concentration (Cmax) of GSK2586881-Part 1|Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period|PK1 Population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2542391|NCT03000686|Secondary|Area Under the Concentration-time Curve Over the Time Period for the Hypoxia Challenge (Immediately Prior to Chamber Entry to Chamber Exit) (AUC [0.5-2 Hours])-Part 2|Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|immediately prior to chamber entry, 60 minutes post-chamber entry, immediately post-exercise and immediately post-chamber exit in each treatment period|PK2 Population|||Hours*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2542392|NCT03000686|Secondary|Area Under the Concentration-time Curve Over the Time Period for the Hypoxia Challenge (Immediately Prior to Chamber Entry to Chamber Exit) (AUC [0.5-2 Hours])-Part 1|Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|immediately prior to chamber entry, 60 minutes post-chamber entry, immediately post-exercise and immediately post-chamber exit in each treatment period|PK1 Population. Only those participants with data available at the specified time points were analyzed.|||Hours*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2542393|NCT03000686|Secondary|Area Under the Concentration-time Curve Over the Study Period (Pre-dose to 30 Minutes Rest Post Chamber Exit) (AUC[0-2.5 Hours])-Part 2|Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period|PK2 Population|||Hours*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2542394|NCT03000686|Secondary|Area Under the Concentration-time Curve Over the Study Period (Pre-dose to 30 Minutes Rest Post Chamber Exit) (AUC[0-2.5 Hours])-Part 1|Blood samples were collected at indicated time points for PK analysis of GSK2586881. The pharmacokinetic parameters were calculated by standard non-compartmental analysis.|pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period|PK1 Population. Only those participants with data available at the specified time points were analyzed.|||Hours*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2542395|NCT03000686|Secondary|Plasma Concentrations of GSK2586881-Part 2|Blood samples were collected at indicated time points for PK analysis of GSK2586881. Pharmacokinetic Part2 (PK2) Population comprised of participants in the mITT population, randomized in Part 2 of the study, for whom a pharmacokinetic sample was obtained and analyzed and on active treatment.|pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period|PK2 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)|||Nanograms per milliliter||Standard Deviation|Mean
2542396|NCT03000686|Secondary|Plasma Concentrations of GSK2586881-Part 1|Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK2586881. Pharmacokinetic Part1 (PK1) Population comprised of participants in the mITT population, randomized in Part 1 of the study, for whom a pharmacokinetic sample was obtained and analyzed and on active treatment.|pre-dose, at infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period|PK1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)|||Nanograms per milliliter||Standard Deviation|Mean
2542397|NCT03000686|Secondary|Number of Participants With Abnormal Urine Parameters-Part 2|Urine samples were collected to analyze the following urine parameters: specific gravity, pH, glucose, protein, blood and ketones by dipstick. Microscopic examination was performed for any abnormal dipstick results. Number of participants with abnormal urine parameters is presented.|Up to 26 days|mITT2 Population|||Participants|||Count of Participants
2542398|NCT03000686|Secondary|Number of Participants With Abnormal Urine Parameters-Part 1|Urine samples were collected to analyze the following urine parameters: specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick. Microscopic examination was performed for any abnormal dipstick results. Number of participants with abnormal urine parameters are presented.|Up to 26 days|mITT1 Population|||Participants|||Count of Participants
2542399|NCT03000686|Secondary|Number of Participants With Abnormal Clinical Chemistry Parameters-Part 2|Blood samples were collected to analyze the following clinical chemistry parameters: BUN, creatinine, glucose, potassium, sodium, calcium, AST, ALT, alkaline phosphatase, total and direct bilirubin, total protein and albumin. Number of participants with abnormal clinical chemistry parameters are presented.|Up to 26 days|mITT2 Population|||Participants|||Count of Participants
2542400|NCT03000686|Secondary|Number of Participants With Abnormal Clinical Chemistry Parameters-Part 1|Blood samples were collected to analyze the following clinical chemistry parameters: blood urea nitrogen (BUN), creatinine, glucose, potassium, sodium, calcium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total and direct bilirubin, total protein and albumin. Number of participants with abnormal clinical chemistry parameters are presented.|Up to 26 days|mITT1 Population|||Participants|||Count of Participants
2542401|NCT03000686|Secondary|Number of Participants With Abnormal Hematology Parameters-Part 2|Blood samples were collected to analyze the following hematology parameters: platelet count, RBC count, hemoglobin, hematocrit, MCV, MCH, WBC count with differential: neutrophils, lymphocytes, monocytes, eosinophils and basophils. Number of participants with abnormal hematology parameters are presented.|Up to 26 days|mITT2 Population|||Participants|||Count of Participants
2542402|NCT03000686|Secondary|Number of Participants With Abnormal Hematology Parameters-Part 1|Blood samples were collected to analyze the following hematology parameters: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), white blood cell (WBC) count with differential: neutrophils, lymphocytes, monocytes, eosinophils and basophils. Number of participants with abnormal hematology parameters are presented.|Up to 26 days|mITT1 Population|||Participants|||Count of Participants
2542403|NCT03000686|Secondary|Number of Participants With Positive Immunogenicity Results-Part 2|Blood samples were collected for immunogenicity testing. Blood samples were tested for anti-ACE2 binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Number of participants with positive incidences for anti-ACE2 binding and neutralizing antibodies is reported.|Up to 26 days|mITT2 Population|||Participants|||Count of Participants
2542404|NCT03000686|Secondary|Number of Participants With Positive Immunogenicity Results-Part 1|Blood samples were collected for immunogenicity testing. Blood samples were tested for anti-angiotensin converting enzyme 2 (ACE2) binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Number of participants with positive incidences for anti-ACE2 binding and neutralizing antibodies is reported.|Up to 26 days|mITT1 Population|||Participants|||Count of Participants
2542405|NCT03000686|Secondary|Number of Participants With AEs and SAEs-Part 2|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability or incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.|Up to 26 days|mITT2 Population|||Participants|||Count of Participants
2542406|NCT03000686|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability or incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before.|Up to 26 days|mITT1 Population|||Participants|||Count of Participants
2542407|NCT03000686|Secondary|Number of Participants With Abnormal ECG Findings-Part 2|Twelve lead ECGs were obtained using an automated ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and QTc intervals. ECG was measured in a semi-supine position after 5 minutes rest. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.|pre-dose, 15 to 45 minutes post-infusion, 60 minutes post-chamber exit in each treatment period|mITT2 Population|||Participants|||Count of Participants
2542408|NCT03000686|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Part 1|Twelve lead ECGs were obtained using an automated ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and corrected QT (QTc) intervals. ECG was measured in a semi-supine position after 5 minutes rest. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.|pre-dose, 15 to 45 minutes post-infusion, 60 minutes post-chamber exit in each treatment period|mITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in category titles)|||Participants|||Count of Participants
2554024|NCT02764190|Secondary|Fruit and Vegetable Consumption|Adolescent self-reported fruits and vegetables consumed in a typical day in past 3 months|12 month|||||||
2542409|NCT03000686|Secondary|Change From Baseline in Oxygen Saturation-Part 2|Oxygen saturation was monitored continuously using pulse oximetry. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted baseline interactions were included. Participant-level Baseline is defined as the mean of the two period-specific baselines. Period-adjusted baseline is defined as the difference between the period-specific baseline and participant-level baseline for each period. No transformation has been applied to the data. Non-informative priors used. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is the post-dose visit value minus Baseline value. Posterior median and 95% credible interval is presented.|Baseline (Day 1, pre-dose), 15 minutes post-infusion, 60 minutes post-chamber entry, 2 minutes post-exercise start, 30 minutes post-chamber exit in each treatment period|mITT2 Population|||Percentage of oxygen||95% Confidence Interval|Median
2542410|NCT03000686|Secondary|Change From Baseline in Oxygen Saturation-Part 1|Oxygen saturation was monitored continuously using pulse oximetry. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted baseline interactions were included. Participant-level Baseline is defined as the mean of the two period-specific baselines. Period-adjusted baseline is defined as the difference between the period-specific baseline and participant-level baseline for each period. No transformation has been applied to the data. Non-informative priors used. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is the post-dose visit value minus Baseline value. Posterior median and 95% credible interval is presented.|Baseline (Day 1, pre-dose), 15 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, 30 minutes post-chamber exit in each treatment period|mITT1 Population. Only those participants with data available at the specified time points were analyzed.|||Percentage of oxygen||95% Confidence Interval|Median
2542411|NCT03000686|Secondary|Change From Baseline in Heart Rate-Part 2|Heart rate was measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.|Baseline (Day 1, pre-dose), 15 to 45 minutes post-infusion, immediately post-exercise and 60 minutes post-chamber exit in each treatment period|mITT2 Population|||Beats per minute||Standard Deviation|Mean
2542412|NCT03000686|Secondary|Change From Baseline in Heart Rate-Part 1|Heart rate was measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.|Baseline (Day 1, pre-dose), 15 to 45 minutes post-infusion, immediately post-exercise and 60 minutes post-chamber exit in each treatment period|mITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in category titles)|||Beats per minute||Standard Deviation|Mean
2542413|NCT03000686|Secondary|Change From Baseline in SBP and DBP-Part 2|SBP and DBP were measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.|Baseline (Day 1, pre-dose), 15 to 45 minutes post-infusion, immediately post-exercise and 60 minutes post-chamber exit in each treatment period|mITT2 Population|||Millimeters of mercury||Standard Deviation|Mean
2542414|NCT03000686|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1|SBP and DBP were measured in a semi-supine position after 5 minutes of rest for the participant. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as the post-dose visit value minus the Baseline value.|Baseline (Day 1, pre-dose), 15 to 45 minutes post-infusion, immediately post-exercise and 60 minutes post-chamber exit in each treatment period|mITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in category titles)|||Millimeters of mercury||Standard Deviation|Mean
2542415|NCT03000686|Secondary|Change From Baseline in RAS Peptides-Part 2|Blood samples were collected to analyze RAS peptides such as Ang II, Ang 1-7 and Ang 1-5. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as post-dose visit value minus Baseline value.|Baseline (Day1, predose) and end of infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period|mITT2 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in category titles).|||Picograms per milliliter||95% Confidence Interval|Geometric Mean
2542416|NCT03000686|Secondary|Change From Baseline in Renin-angiotensin System (RAS) Peptides-Part 1|Blood samples were collected to analyze RAS peptide biomarkers such as angiotensin II (Ang II), Ang 1-7 and Ang 1-5. Baseline is defined as the measurement taken pre-dose during each treatment period (Day1, pre-dose). Change from Baseline is calculated as post-dose visit value minus Baseline value.|Baseline (Day1, predose) and end of infusion, 15 minutes post-infusion, 15 to 45 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise, immediately post-chamber exit and 30 minutes post-chamber exit in each treatment period|mITT1 Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in category titles).|||Picograms per milliliter||95% Confidence Interval|Geometric Mean
2542425|NCT03000452|Secondary|Time to Reach Maximum Concentration (Tmax) of Durvalumab|Time to Cmax, obtained directly from the observed concentration versus time data.|Pharmacokinetic samples were drawn on Cycle 1 on Day 2 (C1D2) pre-dose, at the end of the infusion, on Day 8 at 144 hour post dose, on Day 15 at 312 hours post dose and on Day 22 at 480 hours post C1D2 infusion.|The pharmacokinetic population included participants who received at least 1 dose of study medication and had evaluable plasma PK durvalumab profiles.|||days||Full Range|Median
2542435|NCT03000309|Secondary|% of Patients Achieving Clear or Almost Clear on the PtGA|The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)|Week 8||||Participants|||Count of Participants
2542417|NCT03000686|Primary|Change From Baseline of PASP Measured Via Echocardiography-Part 2|Echocardiograms were obtained with participant resting supine or lying on their left side. Echo during exercise challenge was conducted with participant on a semi-recumbent cycle ergometer tilted by 30 to 40 degrees. PASP was determined by measuring maximal tricuspid regurgitation velocity and applying modified Bernoulli equation to convert this value into pressure values. Change from Baseline is the post-dose visit value minus Baseline value. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted Baseline interactions were included. Participant-level Baseline is the mean of the two period-specific Baselines. Period-adjusted Baseline is the difference between the period-specific Baseline and participant-level Baseline for each period. No transformation has been applied to the data. Posterior median and 95% credible interval is presented.|Baseline (Day1, predose) and 15 minutes post-infusion, 60 minutes post-chamber entry, 2 minutes post-exercise start and 30 minutes post-chamber exit in each treatment period|mITT Part 2 (mITT2) Population comprised of all participants randomized to Part 2 of the study (planned 5000 meter altitude), excluding those randomized in error. Only those participants with data available at the specified time point were analyzed (represented by n=X, X in category titles).|||Millimeters of mercury||95% Confidence Interval|Median
2542418|NCT03000686|Primary|Change From Baseline of Pulmonary Artery Systolic Pressure (PASP) Measured Via Echocardiography-Part 1|Echocardiograms (Echo) were obtained at indicated time points with the participant resting supine or lying on their left side. PASP was determined by measuring maximal tricuspid regurgitation velocity and applying the modified Bernoulli equation to convert this value into pressure values. Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Analysis was performed using a Bayesian repeated measures model adjusting for: participant-level and period-adjusted Baselines, treatment, time and period. Time by treatment and time by period-adjusted Baseline interactions were included. Participant-level Baseline is the mean of two period-specific Baselines. Period-adjusted Baseline is the difference between the period-specific Baseline and participant-level Baseline for each period. No transformation has been applied to the data. Posterior median and 95% credible interval is presented.|Baseline (Day1, predose) and 15 minutes post-infusion, 60 minutes post-chamber entry, immediately post-exercise and 30 minutes post-chamber exit in each treatment period|Modified Intent-To-Treat Part 1 (mITT1) Population comprised of all participants randomized to Part 1 of the study (planned 4000 meter altitude), excluding those randomized in error. Only those participants with data available at the specified time points were analyzed.|||Millimeters of mercury||95% Confidence Interval|Median
2542419|NCT03000608|Secondary|Patients Achieving a Psoriasis Area and Severity Index Score Improvement ≥50% at Any Time-point From Baseline to Day 42 of the Study.|Percentage of patients who have a ≥50% reduction in the Psoriasis Area Severity Index (PASI) score at any time-point from Baseline to Day 42 of the study.|Any time-point from Baseline to Day 42 of the study.|The analysis set used for this outcome measure is the FAS set.|||Participants|||Count of Participants
2542420|NCT03000608|Primary|"Patients Achieving a Physician's Global Assessment of Clear or Almost Clear at Any Time-point From Baseline to Day 42 of the Study"|"The primary preliminary efficacy endpoint will be number of patients achieving a Physician's Global Assessment of clear or almost clear at any time-point during the 42 days of therapy."|Any time-point from Baseline to Day 42|The analysis population for this outcome measure is the FAS set.|||Participants|||Count of Participants
2542421|NCT03000452|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|TEAEs include AEs between the earliest of the first dose date of either study drug and 90 days after the last dose of either study drug. In addition, an AE that occurred beyond the timeframe and was assessed by the doctor as possibly related to IP was considered to be treatment-emergent. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for AEs (NCI CTCAE) version 4.03, where 1= Mild; 2= Moderate; 3= Severe; 4= Life-threatening; 5= Death related to AE. Serious AEs resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in a medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes above.|From the date of the first dose of study drug until 90 days after the last dose of durvalumab or daratumumab , whichever is later. Maximum overall time on treatment was 16 weeks for daratumumab and durvalumab|The safety population consisted of all participants who received at least one dose of Durvalumab (Durva) or Daratumumab (Dara).|||Participants|||Count of Participants
2542422|NCT03000452|Secondary|Apparent Volume of Distribution (Vz/F) of Durvalumab|Apparent volume of distribution, calculated as [(CL/F)/λz].|Pharmacokinetic samples were drawn on Cycle 1 on Day 2 (C1D2) pre-dose, at the end of the infusion, on Day 8 at 144 hour post dose, on Day 15 at 312 hours post dose and on Day 22 at 480 hours post C1D2 infusion.|The pharmacokinetic population included participants who received at least 1 dose of study medication and had evaluable plasma PK durvalumab profiles.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2542423|NCT03000452|Secondary|Apparent Total Clearance (CL/F) of of Durvalumab|Apparent total clearance, calculated as [Dose/AUCinf].|Pharmacokinetic samples were drawn on Cycle 1 on Day 2 (C1D2) pre-dose, at the end of the infusion, on Day 8 at 144 hour post dose, on Day 15 at 312 hours post dose and on Day 22 at 480 hours post C1D2 infusion.|The pharmacokinetic population included participants who received at least 1 dose of study medication and had evaluable plasma PK durvalumab profiles.|||L/day||Geometric Coefficient of Variation|Geometric Mean
2542424|NCT03000452|Secondary|Terminal Half-Life (T1/2) of of Durvalumab|Terminal phase half-life in plasma, calculated as [(ln 2)/λz]. t1/2 was only calculated when a reliable estimate for λz could be obtained.|Pharmacokinetic samples were drawn on Cycle 1 on Day 2 (C1D2) pre-dose, at the end of the infusion, on Day 8 at 144 hour post dose, on Day 15 at 312 hours post dose and on Day 22 at 480 hours post C1D2 infusion.|The pharmacokinetic population included participants who received at least 1 dose of study medication and had evaluable plasma PK Durvalumab profiles.|||days||Geometric Coefficient of Variation|Geometric Mean
2542434|NCT03000309|Secondary|% of Patients Achieving Clear or Almost Clear on the PtGA|The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)|Week 16||||Participants|||Count of Participants
2542426|NCT03000452|Secondary|Maximum Observed Concentration (Cmax) Of Durvalumab|Maximum observed plasma concentration, obtained directly from the observed concentration versus time data.|Pharmacokinetic samples were drawn on Cycle 1 on Day 2 (C1D2) pre-dose, at the end of the infusion, on Day 8 at 144 hour post dose, on Day 15 at 312 hours post dose and on Day 22 at 480 hours post C1D2 infusion.|The pharmacokinetic population included participants who received at least 1 dose of study medication and had evaluable plasma PK durvalumab profiles.|||μg/L||Geometric Coefficient of Variation|Geometric Mean
2542427|NCT03000452|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Extrapolated to Infinity (AUC-inf) of Durvalumab|Area under the plasma concentration-time curve from time 0 extrapolated to infinity, calculated as [AUCt + Ct/ λz]. Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz. If AUC %Extrap was ≥25%, AUC inf was not reported.|Pharmacokinetic samples were drawn on Cycle 1 on Day 2 (C1D2) pre-dose, at the end of the infusion, on Day 8 at 144 hour post dose, on Day 15 at 312 hours post dose and on Day 22 at 480 hours post C1D2 infusion.|The pharmacokinetic population included participants who received at least 1 dose of study medication and had evaluable plasma PK durvalumab profiles.|||day*μg/L||Geometric Coefficient of Variation|Geometric Mean
2542428|NCT03000452|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration Of Durvalumab|Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|Pharmacokinetic samples were drawn on Cycle 1 on Day 2 (C1D2) pre-dose, at the end of the infusion, on Day 8 at 144 hour post dose, on Day 15 at 312 hours post dose and on Day 22 at 480 hours post C1D2 infusion.|The pharmacokinetic population included participants who received at least 1 dose of study medication and had evaluable plasma PK durvalumab profiles.|||day*μg/L||Geometric Coefficient of Variation|Geometric Mean
2542429|NCT03000452|Secondary|Overall Survival|Overall Survival was defined as the time from treatment initiation to death due to any cause. Time to event analysis for overall survival was not analyzed due to insufficient follow up time because of early termination of the trial.|From randomization until the data cut-off date of 17 April 2018. The median duration of treatment for durvalumab and daratumumab was 7.9 weeks and 8.0 weeks respectively.|Analyses was not conducted for overall survival because no participant achieved a best response better than stable disease in Stage 1 of the study. Following the review of the data by the data monitoring committee the sponsor decided to close the study as the number of responses was not reached.||||||
2542430|NCT03000452|Secondary|Progression Free Survival|Progression free survival was defined as the time from treatment initiation to the first documentation of PD or death from any cause during study, whichever occurred earlier. Time to event analysis for PFS and was not analyzed due to insufficient follow up time because of early termination of the trial.|From randomization until the data cut-off date of 17 April 2018. The median duration of treatment for durvalumab and daratumumab was 7.9 weeks and 8.0 weeks respectively.|Analyses was not conducted for PFS because no participant achieved a best response better than stable disease in Stage 1 of the study. Following the review of the data by the data monitoring committee the sponsor decided to close the study as the number of responses were not reached.||||||
2542431|NCT03000452|Secondary|Duration of Response (DOR)|Duration of response was defined as time from the first documentation of response (PR or greater) to the first documentation of PD or death, whichever is earlier, based on the investigator assessments according to the IMWG Uniform Response Criteria.|From randomization until the data cut-off date of 17 April 2018. The median duration of treatment for durvalumab and daratumumab was 7.9 weeks and 8.0 weeks respectively.|Analyses was not conducted for duration of response because no participant achieved a best response better than stable disease in Stage 1 of the study. Following the review of the data by the data monitoring committee the sponsor decided to close the study as the number of responses was not reached.||||||
2542432|NCT03000452|Secondary|Time-to-Response (TTR)|Time-to-response was defined as the time from treatment initiation to the first documentation of response (PR or greater) based on IMWG criteria. sCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. A ≥50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.|From randomization until the data cut-off date of 17 April 2018. The median duration of treatment for durvalumab and daratumumab was 7.9 weeks and 8.0 weeks respectively.|Analyses was not conducted for TTR due to no participant achieving a best response better than stable disease in Stage 1 of the study. Following the review of the data by the data monitoring committee (DMC) the sponsor decided to close the study as the number of responses was not reached.||||||
2542433|NCT03000452|Primary|Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria|Objective response is defined as a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on the investigator assessment: sCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.|From randomization until the data cut-off date of 17 April 2018. The median duration of treatment for durvalumab and daratumumab was 7.9 weeks and 8.0 weeks respectively.|Full Analysis Set = all participants who enrolled in the study.|||percentage of participants|||Number
2542915|NCT02989727|Primary|Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)|Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.|Five weeks||||Participants|||Count of Participants
2542436|NCT03000309|Secondary|Proportion of Patients Who Achieve PASI 75|The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)|Week 16||||Participants|||Count of Participants
2542437|NCT03000309|Secondary|Proportion of Patients Who Achieve PASI 75|The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)|Week 8||||Participants|||Count of Participants
2542438|NCT03000309|Secondary|Proportion of Patients Who Achieve PASI 50|The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)|Week 16||||Participants|||Count of Participants
2542439|NCT03000309|Secondary|Proportion of Patients Who Achieve PASI 50|The Psoriasis Area Severity index (PASI) is performed at screening, baseline, and weeks 4, 8 and 16. This tool is used to measure the severity and extent of disease by combining the assessment of severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease.)|Week 8||||Participants|||Count of Participants
2542440|NCT03000309|Secondary|Percent Change in BSA|The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16|Baseline to Week 16||||percent change||Standard Deviation|Mean
2542441|NCT03000309|Secondary|Percent Change in BSA|The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16|Baseline to Week 8||||percent change||Standard Deviation|Mean
2542442|NCT03000309|Secondary|Mean Change in BSA|The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16|Week 16||||percentage of body surface area affected||Standard Deviation|Mean
2542443|NCT03000309|Secondary|Mean Change in BSA|The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. This will be assessed at screening, baseline, and weeks 4, 8 and 16|Baseline to Week 8||||percentage of body surface area affected||Standard Deviation|Mean
2542444|NCT03000309|Secondary|Mean Change in Pruritus Scores|The Subject Assessments of pruritis is measured at screening, baseline, and weeks 4, 8 and 16. Each subject rates the severity of their itching over the last 24 hours on a 10-point scale from 0 (none) to 10 (unbearable)|Baseline to Week 16||||units on a scale||Standard Deviation|Mean
2542445|NCT03000309|Secondary|Mean Change in Pruritus Scores|The Subject Assessments of pruritis is measured at screening, baseline, and weeks 4, 8 and 16. Each subject rates the severity of their itching over the last 24 hours on a 10-point scale from 0 (none) to 10 (unbearable)|Baseline to Week 8||||units on a scale||Standard Deviation|Mean
2542446|NCT03000309|Secondary|Mean Change in DLQI|The Dermatology Life Quality Index (DLQI) is a 10-question survey administered to subjects in order to ascertain the extent to which psoriasis has affected the patient's life in the week prior to completing the questionnaire. The score is a sum of the value of each answer wherein Very Much=3, A lot=2, A little=1 and Not at all=0. 0 is the lowest possible score and indicates no impact of disease on quality of life. 30 is the highest possible score and indicates the most negative impact of disease on quality of life.|Week 16||||units on a scale||Standard Deviation|Mean
2542447|NCT03000309|Secondary|Mean Change in DLQI|The Dermatology Life Quality Index (DLQI) is a 10-question survey administered to subjects in order to ascertain the extent to which psoriasis has affected the patient's life in the week prior to completing the questionnaire. The score is a sum of the value of each answer wherein Very Much=3, A lot=2, A little=1 and Not at all=0. 0 is the lowest possible score and indicates no impact of disease on quality of life. 30 is the highest possible score and indicates the most negative impact of disease on quality of life.|Week 8||||score on a scale||Standard Deviation|Mean
2542448|NCT03000309|Secondary|Percent Change in Product of BSA and sPGA|The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. Th3 product of these values offers a more specific assessment of the severity of psoriasis. This product may yield a result between 0 (no disease) and 500 (most severe disease.)|Week 8||||percent change||Standard Deviation|Mean
2542449|NCT03000309|Primary|Percent Change in Product of BSA and sPGA|The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. The product of these values offers a more specific assessment of the severity of psoriasis. This product can yield a result between 0(no disease) and 500 (most severe disease.) By reporting the percent change as well as the absolute value change, the reader may be better able to appreciate the impact on disease severity of the medication under study.|Week 16||||percent change||Standard Deviation|Mean
2542472|NCT02999672|Secondary|Plasma/Serum Concentrations of Trastuzumab Emtansine|Samples for evaluation of trastuzumab emtansine, DM1, and total trastuzumab were obtained from all participants from both cohorts at specified time points.|Regimen A: predose (0 minutes [min]) and 15-30 min postinfusion on Days (D) 1, 8, 15 of Cycle (C) 1 and D1C4; predose on D1C2. Regimen B: predose and 15-30 min postinfusion on D1C1 and D1C4; predose on D1C2. 1 Cycle=21 days|Urothelial bladder cancer (UBC) and Pancreatic Cancer/Cholangiocarcinoma cohorts.|||ng/mL||Standard Deviation|Mean
2542450|NCT03000309|Primary|Mean Change in Product of BSA (Body Surface Affected by Psoriasis) and sPGA (Static Physician Global Assessment) From Baseline to Week 16|The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) of disease severity is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. The product of these values offers a more specific assessment of the severity of psoriasis. This product can yield a result between 0 (no disease) and 500 (most severe disease) By reporting the percent change as well as the absolute value change, the reader may be better able to appreciate the impact on disease severity of the medication under study.|Week 16||||score on a scale||Standard Deviation|Mean
2542451|NCT03000283|Secondary|Modified Rankin Scale (mRS) Score|Modified Rankin Scale (0 to 6) at discharge from the hospital. A score of 0 indicates no disability and a score of 6 indicates the patient died. Functional independence is defined as a score of 2 or less.|At discharge from ICU and from hospital, up to 3 weeks||||score on a scale||Full Range|Median
2542452|NCT03000283|Secondary|Cost|"Cost as measured by:~Need for external ventricular drain (EVD)/bolt or surgical procedures (craniectomy, clot evacuation,VPS) for reduction/management of CE.~Need for central venous lines, arterial lines, peripherally inserted central venous catheter (PICC) lines, tracheostomy/percutaneous endoscopic gastrostomies (PEGs).~Number of patients requiring a ventilator."|Baseline to 168 hours post-enrollment||||Participants|||Count of Participants
2542453|NCT03000283|Secondary|Cost|Cost as measured by length of stay in the neuro ICU.|Enrollment through hospital discharge, up to 3 weeks||||days||Full Range|Mean
2542454|NCT03000283|Secondary|Change in Cerebral Edema|Changes in cerebral edema (CE) as measured on CT. Goal is a -5 to -10% change in CE over time. Change will be measured both as absolute change in volume, calculated as the final volume minus the baseline volume measure and converted to a percentage of the baseline volume measure.|Baseline to 168 hours post-enrollment||||percentage of change from baseline||Full Range|Mean
2542455|NCT03000283|Secondary|In-hospital Mortality|All-cause deaths during hospitalization|Enrollment through hospital discharge, up to 3 weeks||||Participants|||Count of Participants
2542456|NCT03000283|Primary|Patient Tolerance of Conivaptan|The number of participants with abnormal seizure activity and/or abnormal lab values and/or increase in infection rate and/or any drug-related adverse events.|Baseline to 168 hours post-enrollment||||Participants|||Count of Participants
2542457|NCT03000088|Primary|Time to Intubation||10 minutes around intubation||||seconds||Standard Deviation|Mean
2542458|NCT03000075|Secondary|Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an ACR20 at Week 52 (Part B)|Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.|Week 52|Among participants with confirmed diagnosis of PsA using CASPAR criteria and with baseline TJC and SJC counts ≥ 3 at selected study sites of the ITT population,|||percentage of participants|||Number
2542459|NCT03000075|Secondary|Percentage of Participants (ITT Participants in Select Study Sites With Confirmed Diagnosis of Psoriatic Arthritis and Baseline Total Tender and Swollen Joint Count ≥ 3) Achieving an American College of Rheumatology 20 Response (ACR20) at Week 16 (Part A)|Response defined by ACR20 criteria (improvement from baseline): ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: Patient assessment of pain; Patient global assessment of disease activity; Investigator's global assessment of disease activity; Health Assessment Questionnaire Disability Index (HAQ-DI); and Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.|Week 16|Among participants with confirmed diagnosis of PsA using classification criteria for psoriatic arthritis (CASPAR) and with baseline total tender joint count (TJC) and swollen joint count (SJC) counts ≥ 3 at selected study sites of the ITT population.|||percentage of participants|||Number
2542460|NCT03000075|Secondary|Percentage of Participants Achieving PASI100 at Week 52 (Part B)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.|Week 52|ITT population|||percentage of participants|||Number
2542461|NCT03000075|Secondary|Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 (Part A)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2542473|NCT02999672|Secondary|Percentage of Participants With Drug-induced Liver Injury Meeting Hy's Law Criteria|Participants from both cohorts (UBC and Pancreatic cancer/cholangiocarcinoma) were analyzed for drug-induced liver injury following Hy's Law. Hy's Law criteria for potential drug-induced liver injury includes an elevated ALT (alanine aminotransferase) or AST (aspartate aminotransferase) in combination with either elevated bilirubin or clinical jaundice.|Baseline up to approximately 18 months|Urothelial bladder cancer (UBC) and Pancreatic Cancer/Cholangiocarcinoma cohorts|||Percentage of Participants|||Number
2542462|NCT03000075|Secondary|Percentage of Participants Achieving PASI75 at Week 52 (Part B)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.|Week 52|ITT population|||percentage of participants|||Number
2542463|NCT03000075|Secondary|Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 (Part A)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2542464|NCT03000075|Secondary|Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 (Part B)|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. Nonresponder imputation (NRI) was used for missing data.|Week 52|ITT population|||percentage of participants|||Number
2542465|NCT03000075|Secondary|Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. Nonresponder imputation (NRI) was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2542466|NCT03000075|Secondary|Percentage of Participants Achieving PASI90 at Week 52 (Part B)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.|Week 52|ITT population|||percentage of participants|||Number
2542467|NCT03000075|Primary|Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.|Week 16|Intent-to-treat (ITT) population: all participants who were randomized.|||percentage of participants|||Number
2542468|NCT02999763|Other Pre-specified|"Number of Treatments Where Participants Reported Having Mild, Moderate or Severe Response"|"Discomfort and immediate response will be assessed immediately after each treatment using the Post Treatment Immediate Response severity scale (Absent/none, Mild, Moderate and Severe). The values in the data table reflect the number of participants who had discomfort during treatment or immediate response after treatment (reported as having Mild, Moderate or Severe )"|First, second and third treatments, Weeks 0 to 4|70 participants attended the first treatment, 67 participants attended the second treatment (2 dropped and 1 missed treatment) and 65 participants attended the third treatment (3 dropped and 2 missed treatment), therefore overall 202 treatments conducted during the study.|||Overall Treatments|Overall Treatments||Count of Units
2542469|NCT02999763|Secondary|Change in Abdominal Circumference After Treatments Compared to Baseline|Change in abdominal circumference, measured by calibrated measuring tape, at 4, 8 and 12 weeks follow-up (after final treatment) compared to baseline|At 4 weeks, 8 weeks and 12 weeks follow-up (post last treatment)|63 participants attended the 4 week FU (5 dropped and 2 missed the visit), 59 participants attended the 8 week FU (10 dropped and 1 missed the visit), 58 participants attended the 12 week FU (12 Subjects dropped)|||centimeter||Standard Deviation|Mean
2542470|NCT02999763|Secondary|Change in Fat Thickness After Treatments Compared to Baseline|Abdominal fat change, measured by ultrasound, post SlimShape treatments at 4 and 8 weeks follow-up after final treatment compared to baseline|Baseline and 4 and 8 weeks follow-up|63 participants attended the 4 week FU (5 dropped and 2 missed the visit), 59 participants attended the 8 week FU (10 dropped and 1 missed the visit)|||millimeters||Standard Deviation|Mean
2542471|NCT02999763|Primary|Change in Fat Thickness at Final Follow-up Compared to Baseline|Abdominal fat change, measured by ultrasound, post SlimShape treatments at 12 weeks follow-up (12wk FU) compared to baseline|Baseline and 12 weeks follow-up|58 participants analyzed at 12 week FU (12 subjects lost to follow-up at final visit)|||millimeters||Standard Deviation|Mean
2542474|NCT02999672|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)|Incidence, type and severity of all adverse events (AEs) and serious adverse events (SAEs), based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03).|Baseline up to approximately 18 months|Urothelial bladder cancer (UBC) and Pancreatic Cancer/Cholangiocarcinoma cohorts|||Percentage of Participants|||Number
2542475|NCT02999672|Secondary|Overall Survival (OS)|OS was determined as the time from beginning of treatment to death from any cause.|Baseline up to PD/recurrence or death, whichever occurs first (up to approximately 18 months)|Urothelial bladder cancer (UBC) and Pancreatic Cancer/Cholangiocarcinoma cohorts|||Months||95% Confidence Interval|Median
2542476|NCT02999672|Secondary|Progression-Free Survival (PFS)|PFS was the time from inclusion in the study to the date of first documented PD or death from any cause, whichever occurred first. Participants without event were censored at the date of the last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of disease progression, the participant was censored at the date of last tumor assessment before starting new chemotherapy. PD was defined as at least a 20% increase in the sum of longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Baseline up to PD/recurrence or death, whichever occurs first (up to approximately 18 months)|Urothelial bladder cancer (UBC) and Pancreatic Cancer/Cholangiocarcinoma cohorts|||Months||95% Confidence Interval|Median
2542477|NCT02999672|Primary|Best Overall Response (BOR) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors [RECIST] 1.1).|BOR was defined as having best objective response as complete response (CR) or partial response (PR), as assessed by investigator and confirmed at least 28 days after initial response, according to the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1). CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must decrease to normal (short axis less than [<] 10 millimeter [mm]). PR was defined as a 30% decrease in the sum of the diameters of the target lesions taking as a reference the baseline sum diameter. Percentage of participants with best overall response of CR or PR are reported.|Baseline up to PD/recurrence or death, whichever occurs first (up to approximately 18 months)|Urothelial bladder cancer (UBC) and Pancreatic Cancer/Cholangiocarcinoma cohorts|||Percentage of Treated Participants|||Number
2542478|NCT02999633|Secondary|Number of Participants With Minimal Residual Disease (MRD)|Presence of MRD was measured by sequencing and/or flow cytometry in participants achieving CR and CRi. CR was defined as no circulating blasts or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement, trilineage hematopoiesis and less than 5 percentage blasts, ANC greater than 1000 per micro liter, platelets less than 100 000 per micro liter, no recurrence for 4 weeks. Complete response with incomplete blood count recovery meet all criteria for complete response except platelet count and/or ANC.|Baseline until death or study cut-off (maximum duration: 12.1 weeks)|Data for this outcome measure was not collected and analyzed because no participant achieved CR or CRi.||||||
2542479|NCT02999633|Secondary|Overall Survival (OS)|Overall Survival was defined as the time interval from the date of first study drug administration to the date of death due to any cause.|Baseline until death (maximum duration: 12.1 weeks)|This outcome measure was not analyzed because overall survival data were not collected.||||||
2542480|NCT02999633|Secondary|Progression Free Survival (PFS)|PFS was defined as the time interval (in days) from the date of first study drug administration to the date of first observation of PD or death due to any cause, whichever came first. PD as per NCCN guidelines was defined as increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease.|Baseline until disease progression or death (maximum duration: 12.1 weeks)|This outcome measure was not analyzed because disease progression data were not collected.||||||
2542481|NCT02999633|Secondary|Duration of Response (DOR)|DOR defined as time (in days) from date of first response until date of first documented progressive disease (PD) or death (from any cause), whichever came first. Progressive disease as per NCCN guidelines was defined as increase of at least 25 percentage (%) in the absolute number of circulating or bone marrow blasts or development of extramedullary disease.|Baseline until disease progression or death (maximum duration: 12.1 weeks)|The outcome measure was not analyzed due to lack of objective response. There was no specific additional data collected for the analysis of DOR as this outcome measure was to be derived using time point responses and death information that were collected and analyzed as part of primary and safety outcome measures, respectively.||||||
2542482|NCT02999633|Primary|Percentage of Participants With Objective Response|Objective response was defined as percentage of participants with complete response (CR) or with complete response with incomplete peripheral recovery (CRi) as per National Comprehensive Cancer Network (NCCN) guidelines. CR was defined as no circulating blasts or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement, trilineage hematopoiesis and less than 5 percentage blasts, absolute neutrophil count (ANC) greater than 1000 per micro liter, platelets less than 100 000 per micro liter, no recurrence for 4 weeks. CRi meet all criteria for complete response except platelet count and/or ANC.|Baseline until disease progression or death (maximum duration: 12.1 weeks)|Safety analysis set included all participants who received at least 1 dose of isatuximab.|||percentage of participants||95% Confidence Interval|Number
2542483|NCT02999100|Secondary|Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Three Hours (AUC ([0-3]) of Oxytocin|Blood samples were collected at indicated time points to evaluate AUC (0-3) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours and 3 hours post dose on Day 1|Pharmacokinetic Population.|||Hour*picogram per milliliter||Standard Deviation|Mean
2542484|NCT02999100|Secondary|Part 1: Change From Baseline in Body Temperature|Body temperature was measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose|Safety Population. Only those participants with data available at specified data points were analyzed.|||Degrees Celsius||Standard Deviation|Mean
2542485|NCT02999100|Secondary|Part 1: Change From Baseline in Respiration Rate|Respiration rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose|Safety Population. Only those participants with data available at specified data points were analyzed.|||Breaths per minute||Standard Deviation|Mean
2542486|NCT02999100|Secondary|Part 1: Change From Baseline in Heart Rate|Heart rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose|Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).|||Beats per minute||Standard Deviation|Mean
2542487|NCT02999100|Secondary|Part 1: Change From Baseline in SBP and DBP|SBP and DBP of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1, pre-dose), 30 minutes and 2 hours post dose|Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).|||Millimeters of mercury||Standard Deviation|Mean
2542488|NCT02999100|Secondary|Part 1: Absolute Values of Temperature|Body temperature was measured in semi-supine position after 5 minutes rest|30 minutes and 2 hours post dose|Safety Population. Only those participants with data available at specified data points were analyzed.|||Degrees Celsius||Standard Deviation|Mean
2542489|NCT02999100|Secondary|Part 1: Absolute Values of Respiration Rate|Respiration rate was measured in semi-supine position after 5 minutes rest|30 minutes and 2 hours post dose|Safety Population. Only those participants with data available at specified data points were analyzed.|||Breaths per minute||Standard Deviation|Mean
2542490|NCT02999100|Secondary|Part 1: Absolute Values of Heart Rate|Heart rate was measured in semi-supine position after 5 minutes rest|30 minutes and 2 hours post dose|Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).|||Beats per minute||Standard Deviation|Mean
2542491|NCT02999100|Secondary|Part 1: Absolute Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.|30 minutes and 2 hours post dose|Safety Population. Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles).|||Millimeters of mercury||Standard Deviation|Mean
2542492|NCT02999100|Secondary|Part 1: Number of Participants With Non-SAEs and SAEs|An adverse event is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function.|Up to 15 days|Safety Population includes participants who received at least one dose of study medication|||Participants|||Count of Participants
2542493|NCT02999100|Primary|Part 2: Time to Reach Terminal Phase Half-life (t1/2) of Oxytocin|Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Participants analysed (22) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.|||Hours||Full Range|Median
2542494|NCT02999100|Primary|Part 2: Volume of Distribution (VOD) of Oxytocin for IV Route Only|Blood samples were collected at indicated time points to evaluate volume of distribution of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|-1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Only IV reporting arms presented.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2542495|NCT02999100|Primary|Part 2: Plasma Clearance (CL) of Oxytocin for IV Route Only|Blood samples were collected at indicated time points to evaluate plasma clearance of oxytocin IV bolus and infusion. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|-1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Only IV reporting arms presented.|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2542496|NCT02999100|Primary|Part 2: Area Under the Concentration-time Curve From Time Zero Extrapolated to Time 't' (AUC[0-t]) of Oxytocin|Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|-1 hour,-30 minutes,-15 minutes Pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Participants analysed (23) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.|||Hour*picogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2554025|NCT02764190|Secondary|Fruit and Vegetable Consumption|Adolescent self-reported fruits and vegetables consumed in a typical day in past 3 months|6 month|||||||
2542497|NCT02999100|Primary|Part 2: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin|Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Participants analysed (23) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.|||Hours||Full Range|Median
2542498|NCT02999100|Primary|Part 2: Observed Plasma Concentration (Cp)30 of Oxytocin|Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|30 minutes post dose|Pharmacokinetic Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.|||Picogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2542499|NCT02999100|Primary|Part 2: Observed Plasma Concentration (Cp)20 of Oxytocin|Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|20 minutes post dose|Pharmacokinetic Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.|||Picogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2542500|NCT02999100|Primary|Part 2: Observed Plasma Concentration (Cp)10 of Oxytocin|Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|10 minutes post dose|Pharmacokinetic Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.|||Picogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2542501|NCT02999100|Primary|Part 2: Maximum Observed Plasma Concentration (Cmax) of Oxytocin|Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed. Participants analysed (23) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.|||Picogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2542502|NCT02999100|Primary|Part 2: Plasma Concentration Time Profile of Oxytocin.|Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|-1 hour,-30 minutes,-15 minutes pre-dose, 2 minutes, 3 minutes, 5 minutes, 8 minutes,10 minutes, 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours and 4 hours post dose|Pharmacokinetic Population. Only those participants with data available at specified data points were analyzed (represented by n=X in category titles). Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.|||Picograms per milliliter||Full Range|Median
2542503|NCT02999100|Primary|Part 2: Absolute Values of Respiration Rate|Respiration rate was measured in semi-supine position after 5 minutes rest|Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post-dose|Safety Population. Only those participants with data available at specified data points were analyzed (represented by n=X in category titles). Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.|||Breaths per minute||Standard Deviation|Mean
2542504|NCT02999100|Primary|Part 2: Percent Oxygen in Blood|Percent oxygen in blood was measured using pulse oximetry in a semi-supine position after 5 minutes rest. Pulse oximeter is a device that measures oxygen saturation of arterial blood in participants by utilizing a sensor attached typically to a finger, toe, or ear to determine the percentage of oxyhemoglobin in blood pulsating through a network of capillaries|Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post-dose|Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.|||Percentage of oxygen||Standard Deviation|Mean
2542505|NCT02999100|Primary|Part 2: Forced Expiratory Volume at 1 Minute (FEV1)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 measurements were taken electronically by spirometry on Day 1. At each time point, three best measurements were recorded.|Pre dose and 1 hour post dose on Day1|Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.|||Liters||Standard Deviation|Mean
2542506|NCT02999100|Primary|Part 2: Number of Participants With Abnormal Respiratory Events|Number of participants with abnormal respiratory events has been presented|Up to Day 37|Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.|||Participants|||Count of Participants
2542507|NCT02999100|Primary|Part 2: Absolute Values of PR Interval, QRS Duration, Corrected QT Interval Using Bazett's (QTcB) Formula and Corrected QT Interval Using Fredericia's Formula (QTcF) Interval|Triplicate 12-lead electrocardiograms (ECGs) were recorded pre-dose and post-dose with participant in semi-supine position after 5 minutes rest. At each time point ECG was taken using an ECG machine that automatically measured PR interval, QRS duration, QTcB interval, and QTcF interval.|Pre-dose, 2 minutes, 10 minutes, 20 minutes, 30 minutes, 1 hour and 4 hours post dose|Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.|||Milliseconds||Standard Deviation|Mean
2554026|NCT02764190|Secondary|Sweetened Beverage Consumption|Adolescent self-reported sweetened beverages consumed in a typical day in past 3 months|12 month|||||||
2542508|NCT02999100|Primary|Part 2: Absolute Values of Heart Rate|Heart rate was measured in semi-supine position after 5 minutes rest|Pre dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose|Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.|||Beats per minute||Standard Deviation|Mean
2542509|NCT02999100|Primary|Part 2: Change From Baseline in Heart Rate|Heart rate of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1, pre-dose), 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose|Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.|||Beats per minute||Standard Deviation|Mean
2542510|NCT02999100|Primary|Part 2: Change From Baseline in SBP and DBP|SBP and DBP of participants were measured at indicated time points in semi-supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment with a non-missing value at Day 1 (Pre-dose). Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1, pre-dose), 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose|Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.|||Millimeters of mercury||Standard Deviation|Mean
2542511|NCT02999100|Primary|Part 2: Absolute Values of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure of participants were measured at indicated time points in semi-supine position after 5 minutes rest.|Pre-dose, 5 minutes, 15 minutes, 30 minutes, 1 hour and 4 hours post dose|Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.|||Millimeters of mercury||Standard Deviation|Mean
2542512|NCT02999100|Primary|Part 2: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)|An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. As SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety Population includes participants who received at least one dose of study medication.|Up to 37 days|Safety Population. Participants analysed (25) is greater than the number participants (14) started in Part 2 because Part 2 is a crossover design and participants were considered for 2 dosing sessions.|||Participants|||Count of Participants
2542513|NCT02999100|Primary|Part 1: Terminal Phase Half-life (t1/2) of Oxytocin|Blood samples were collected at indicated time points to evaluate t1/2 of oxytocin.|Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose on Day 1|Pharmacokinetic Population.|||Hours||Full Range|Median
2542514|NCT02999100|Primary|Part 1: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of Oxytocin|Blood samples were collected at indicated time points to evaluate AUC (0-t) of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose on Day 1|Pharmacokinetic Population.|||Hour*picogram per milliliter||Full Range|Median
2542515|NCT02999100|Primary|Part 1: Time to Reach Maximum Observed Concentration (Tmax) of Oxytocin|Blood samples were collected at indicated time points to evaluate Tmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1|Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed.|||Hours||Full Range|Median
2542516|NCT02999100|Primary|Part 1: Observed Plasma Concentration (Cp) 30 of Oxytocin|Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|30 minutes post dose Day 1|Pharmacokinetic Population.|||Picogram per milliliter||Full Range|Median
2542517|NCT02999100|Primary|Part 1: Observed Plasma Concentration (Cp) 20 of Oxytocin|Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|20 minutes post dose Day 1|Pharmacokinetic Population.|||Picogram per milliliter||Full Range|Median
2542518|NCT02999100|Primary|Part 1: Observed Plasma Concentration (Cp) 10 of Oxytocin|Blood samples were collected at indicated time points to evaluate observed plasma concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|10 minutes post dose Day 1|Pharmacokinetic Population.|||Picogram per milliliter||Full Range|Median
2542519|NCT02999100|Primary|Part 1: Maximum Observed Plasma Concentration (Cmax) of Oxytocin|Blood samples were collected at indicated time points to evaluate Cmax of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1|Pharmacokinetic Population.|||Picograms per milliliter||Full Range|Median
2542520|NCT02999100|Primary|Part 1: Plasma Concentration Time Profile of Oxytocin|Blood samples were collected at indicated time points to evaluate concentration of oxytocin. Pharmacokinetic parameters were calculated by standard non-compartmental analysis.|Predose, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, 2 hours, 2.5 hours, 3 hours and 4 hours post dose Day 1|Pharmacokinetic Population includes all participants in Safety population for whom a pharmacokinetic sample was obtained & analysed.Safety Population includes participants who received at least one dose of study medication.Only those participants with data available at specified data points were analyzed (represented by n= X in the category titles)|||Picograms per milliliter||Full Range|Median
2542524|NCT02998684|Primary|Test of Adolescent Social Skills Knowledge (TASSK)|Change in TASSK raw scores from pre- to post-treatment, i.e., baseline to 14-weeks (Post minus pre-treatment: positive scores indicate improvement). Assessment scores can range from 0 to 26, 0 being the lowest possible score and 26 being the highest.|Baseline to 14-weeks|Number of participants who completed study questionnaire pre and post-treatment|||score on a scale||Standard Deviation|Mean
2542525|NCT02998671|Secondary|Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters|Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.|38 Weeks|Safety Analysis Set|||Participants|||Count of Participants
2542526|NCT02998671|Secondary|Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters|Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.|38 Weeks|Safety Analysis Set|||Participants|||Count of Participants
2542527|NCT02998671|Secondary|Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters|Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.|38 Weeks|Safety Analysis Set|||Participants|||Count of Participants
2542528|NCT02998671|Secondary|Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2|Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.|Day 85, Day 113, Day 141 and Day 169|Pharmacokinetic analysis set|||ng/mL||Standard Deviation|Mean
2542529|NCT02998671|Secondary|Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1|Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.|Day 1, Day 29, Day 57 and Day 85|Pharmacokinetic analysis set|||ng/mL||Standard Deviation|Mean
2542530|NCT02998671|Secondary|Number and Severity of Adverse Events in Period 2|Frequency and severity of adverse events in Period 2|Day 86 to Day 260|Safety analysis set|||Adverse Events|||Number
2542531|NCT02998671|Secondary|Number and Severity of Adverse Events in Period 1|Frequency and severity of adverse events in Period 1|Day 1 to Day 85|Safety analysis set|||Adverse Events|||Number
2542532|NCT02998671|Primary|Total Inflammatory Facial Lesion Count at Day 85|Total inflammatory facial lesion count was the total count of papules, pustules and nodules assessed at day 85|Day 85|Pharmacodynamic analysis set, including only patients completing 12-week assessments.|||Lesions||90% Confidence Interval|Geometric Mean
2542533|NCT02998476|Secondary|Safety as Assessed by Percentage of Subjects With Adverse Events in Group A and Group B|A TEAE is any AE either reported for the first time or worsening of a pre-existing event after the first dose of parsaclisib until 30 days after the last dose administration.|Screening through 35 days after end of treatment, up to 42 months||2020-07-31|07/2020||||
2542534|NCT02998476|Secondary|Overall Survival (OS) in Group A|Defined as the time from the date of the first dose of study drug until death by any cause.|From first dose of study drug until death by any cause; up to 26 months|The full analysis set includes all subjects enrolled in the study who received at least 1 dose of INCB050465|||months||95% Confidence Interval|Median
2542535|NCT02998476|Secondary|Progression-free Survival in Group A|Defined as the time from the date of the first dose of study drug until the earliest date of disease progression, as determined by radiographic disease assessment as provided by an IRC.|Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months|The full analysis set includes all subjects enrolled in the study who received at least 1 dose of INCB050465|||months||95% Confidence Interval|Median
2542536|NCT02998476|Secondary|Duration of Response in Group A|Defined as the time from first documented evidence of complete or partial response until disease progression or death from any cause among subjects who achieve an objective response as determined by IRC.|Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months|The full analysis set includes all subjects enrolled in the study who received at least 1 dose of INCB050465|||months||95% Confidence Interval|Median
2542537|NCT02998476|Primary|Objective Response Rate Based on Lugano Classification Criteria in Group A|Defined as the percentage of subjects with a complete or partial response as defined by Lugano Classification criteria for lymphomas (Cheson et al 2014) as determined by IRC.|Every 9 weeks through Week 27, then every 18 weeks thereafter until disease progression, up to 26 months|The full analysis set includes all subjects enrolled in the study who received at least 1 dose of INCB050465|||percentage||95% Confidence Interval|Number
2542538|NCT02998021|Secondary|Power Output|Measurement of peak power output (watts/kg) using the Load Arm Ergometer.|Baseline and 12 weeks|Subjects in the control group withdrew before the 12 week visit|||Watts/kg||Standard Deviation|Mean
2542539|NCT02998021|Secondary|Wheelchair Transfer Ability|Measurement of relative transfer range. Measured as the change in relative uphill (maximum) transfer height (inches).|Baseline and 12 weeks|Subjects in the control group withdrew before the 12 week visit|||inches||Full Range|Median
2542540|NCT02998021|Secondary|Change in Mechanical Effective Force|Change in mechanical effective force during 250 foot level propulsion task (no unit) Measurement will be done using the SmartWheel.|Baseline and 12 weeks|Subjects in the control group withdrew before the 12 week visit. There were technical issues prevention SmartWheel data collection for 3 subjects in the intervention group.|||unitless||Standard Deviation|Mean
2542541|NCT02998021|Secondary|Change in Peak Force|Change in peak force (N) during the 250 foot level propulsion task. Measurement was done using the SmartWheel.|Baseline and 12 weeks|Subjects in the control group withdrew before the 12 week visit. There were technical issues preventing the SmartWheel data collection for 3 subjects in the intervention group|||Newtons||Standard Deviation|Mean
2542542|NCT02998021|Secondary|Change in Acceleration|Change in acceleration (seconds) during the 250 foot level propulsion task.|Baseline and 12 weeks|Subjects in the control group withdrew before the 12 week visit|||seconds||Standard Deviation|Mean
2542543|NCT02998021|Secondary|Change in Peak Speed|Change in peak speed (m/s) measured on a 3 degree incline. Measurement will be done using the SmartWheel.|Baseline and 12 weeks|Subjects in the control group withdrew before the 12 week visit. There were technical issues that prevented SmartWheel data collection for 3 subjects in the intervention group.|||meters/second||Standard Deviation|Mean
2554027|NCT02764190|Secondary|Sweetened Beverage Consumption|Adolescent self-reported sweetened beverages consumed in a typical day in past 3 months|6 month|||||||
2542544|NCT02998021|Primary|Changes in Functional Shoulder Pain|Score generated by the Wheelchair Users Shoulder Pain Index. Participants self report shoulder pain over the past week while performing activities of daily living. Scores range from 1 to 150 where higher scores represent higher levels of pain.|Baseline and 12 weeks|Subjects in the control group withdrew before the 12 week visit|||units on the scale||Standard Deviation|Mean
2542545|NCT02998021|Primary|Change in General Health Measures|Score generated by the Short Form 36 walk-wheel. Participants self report on health questions within 8 domains each of which are scored from 0 to 100. The scores from each of the subscales are then averaged together to obtain an overall total score. A score of 0 represents the worst possible health state and a score of 100 represents the best possible health state.|Baseline and 12 weeks|Subjects in the control group withdrew before the 12 week visit|||units on the scale||Standard Deviation|Mean
2542546|NCT02998021|Primary|Change in Upper Extremity Pain|Score generated by the Numerical Rating Scale for shoulder pain. Participants self report upper extremity pain over the last 24 hours with scores on a 0 to 10 scale. Higher scores represent higher levels of pain.|Baseline and 12 weeks|Subjects in the control group withdrew before the 12 week visit|||units on the scale||Full Range|Median
2542547|NCT02998021|Primary|Change in Strength|Measurement of peak torque (Nm/kg) for Shoulder Adduction. Measurement was done using the Biodex System.|Baseline and 12 weeks|Subjects in the control group withdrew before the 12 week visit. There were technical problems with collected the strength data for one subject in the intervention group.|||Nm/kg||Standard Deviation|Mean
2542548|NCT02997904|Secondary|Total Number of Lice Removed, Total Number of Eggs Removed|Total number of lice removed after one hour of combing and total number of eggs removed after one hour of combing, analyzed separately|1 hour|Intent To Treat; including all subjects enrolled|||Number of Lice or Number of Eggs||Standard Deviation|Mean
2542549|NCT02997904|Primary|The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing|A superiority analysis comparing the total number of lice + eggs removed from the head after one hour of combing with the Resultz Kit versus the control. The Resultz Kit was considered a success if the Resultz Kit was superior to the control.|1 hour|Intent To Treat; including all subjects who were enrolled in the study.|||number of lice and eggs removed||Standard Deviation|Mean
2542550|NCT02997735|Other Pre-specified|Characteristics Associated With Successful Quitline Enrollment, Quit Stage|Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.|Through study completion, up to 1 year||||Participants|||Count of Participants
2542551|NCT02997735|Other Pre-specified|Characteristics Associated With Successful Quitline Enrollment, Cigarettes Smoked Per Day|Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.|Through study completion, up to 1 year||||Participants|||Count of Participants
2542552|NCT02997735|Other Pre-specified|Characteristics Associated With Successful Quitline Enrollment, Asthma Diagnosis (Child)|Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.|Through study completion, up to 1 year||||Participants|||Count of Participants
2542553|NCT02997735|Other Pre-specified|Characteristics Associated With Successful Quitline Enrollment, Parent Age|Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.|Through study completion, up to 1 year||||Participants|||Count of Participants
2542554|NCT02997735|Other Pre-specified|Characteristics Associated With Successful Quitline Enrollment, Patient Age|Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.|Through study completion, up to 1 year||||Participants|||Count of Participants
2542555|NCT02997735|Other Pre-specified|Characteristics Associated With Successful Quitline Enrollment, Study Arm|Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment. The Odds Ratios (ORs) from multivariable logistic regression model of characteristics associated with successful quitline enrollment.|Through study completion, up to 1 year||||Participants|||Count of Participants
2542556|NCT02997735|Secondary|Number of Parents Who Quit Smoking|Self-reported parent quit rates post-enrollment, compared between the intervention and control and reported by the PA Quitline|Through study completion, up to 1 year||||Participants|||Count of Participants
2542557|NCT02997735|Secondary|Number of Calls With the Quitline|Total number of parent contacts with the quitline post-enrollment, compared between intervention and control and reported by the PA Quitline|Through study completion, up to 1 year||||Participants|||Count of Participants
2542558|NCT02997735|Primary|Number of Parent Smokers Who Enrolled in Quitline|Proportion of parent smokers identified in clinic that enroll in quitline treatment compared across the intervention (electronic referral) and control (standard of practice) approaches. Primary analysis wibased on an intent to treat approach and includes all subjects randomized at their referral visit.|Through study completion, up to 1 year||||Participants|||Count of Participants
2542559|NCT02997722|Primary|Inpatient Hospital Length of Stay|We defined length of hospital stay as the difference between 1) the date and time that the patient was admitted to the psychiatry inpatient unit and 2) the date and time that the patient was discharged from the psychiatry inpatient.|After discharge from the inpatient psychiatry unit.||||hours||Full Range|Mean
2542560|NCT02997163|Secondary|Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status|As per ECOG, participant's performance status was measured on 5 point scale: 0=fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature, e.g., light housework, office work. 2= ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5: dead.|Baseline, Safety follow up (Day 52)|Safety analysis included all participants who received any amount of talazoparib. Here, “Number Analyzed” signifies participants who were evaluable at specific rows.|||Participants|||Count of Participants
2543331|NCT02980601|Primary|Wrist Range of Motion- Extension|Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension|1 year|Data not collected||||||
2542561|NCT02997163|Secondary|Number of Participants With Laboratory Abnormalities|Laboratory parameters: erythrocytes, hematocrit, hemoglobin, white blood cells, absolute neutrophil count, lymphocytes, platelets ; albumin, alkaline phosphatase, alanine aminotransferase, aspartate transaminase , bilirubin, bicarbonate, blood urea nitrogen , calcium, chloride, creatinine, gamma -glutamyl transferase, glucose, lactate dehydrogenase, sodium, phosphate, potassium, total protein, uric acid, follicle-stimulating hormone; international normalized ratio / prothrombin time [activated] partial thromboplastin time; Urinalysis (pH, specific gravity, protein, glucose, ketones, bilirubin, blood, leukocyte esterase); Serum pregnancy test; Serology for Human Immunodeficiency Virus (HIV). Number of participants with laboratory test abnormalities as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) version 4.03 were reported: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.|Baseline up to 30 days after last dose of study drug (up to 52 days)|Safety analysis included all participants who received any amount of talazoparib.|||Participants|||Count of Participants
2542562|NCT02997163|Secondary|Number of Participants With Electrocardiogram (ECG) Abnormalities|ECG parameters included pulse rate (PR) interval, QRS duration, QT interval and corrected QT interval using Fridericia's formula (QTcF). Abnormality criteria: 1) PR interval: greater than equal to (>=) 25 percent (%) increase when baseline >= 300 msec; 2) QRS duration: >=50% increase when baseline >=140 msec; 3) QT interval: >= 500 msec: 4) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) >= 500 msec when baseline >= 60. IFB stands for increase from baseline.|Baseline up to 30 days after last dose of study drug (up to 52 days)|Safety analysis included all participants who received any amount of talazoparib.|||Participants|||Count of Participants
2542563|NCT02997163|Secondary|Change From Baseline in Body Weight of Participants||Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)|"Safety analysis included all participants who received any amount of talazoparib. Here, number analyzed signifies participants evaluable for specific rows."|||kilograms||Standard Deviation|Mean
2542564|NCT02997163|Secondary|Change From Baseline in Respiratory Rate of Participants|Respiratory rate was measured in terms of breaths per minute.|Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)|"Safety analysis included all participants who received any amount of talazoparib. Here, number analyzed signifies participants evaluable for specific rows."|||breaths per minute||Standard Deviation|Mean
2542565|NCT02997163|Secondary|Change From Baseline in Heart Rate of Participants|Heart rate was measured in terms of beats per minute.|Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)|"Safety analysis included all participants who received any amount of talazoparib. Here, number analyzed signifies participants evaluable for specific rows."|||beats per minute||Standard Deviation|Mean
2542566|NCT02997163|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) of Participants||Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)|"Safety analysis included all participants who received any amount of talazoparib. Here, number analyzed signifies participants evaluable for specific rows."|||mmHg||Standard Deviation|Mean
2542567|NCT02997163|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) of Participants||Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)|"Safety analysis included all participants who received any amount of talazoparib. Here, number analyzed signifies participants evaluable for specific rows."|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2542568|NCT02997163|Secondary|Number of Participants With Abnormalities in Physical Examination|Physical examination included examination of the general appearance, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Findings were considered to be abnormal based on investigator's decision.|Baseline up to 30 days after last dose of study drug (up to 52 days)|Safety analysis included all participants who received any amount of talazoparib.|||Participants|||Count of Participants
2542569|NCT02997163|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of investigational product and up to 30 days after the last dose of investigational product (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline up to 30 days after last dose of study drug (up to 52 days)|Safety analysis included all participants who received any amount of talazoparib.|||Participants|||Count of Participants
2542570|NCT02997163|Secondary|Multiple Dose: Renal Clearance (CLr) of Talazoparib at Day 22|Renal clearance was calculated as cumulative amount of drug excreted in urine during the 24 hours dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to 24 hours postdose.|0 to 24 hours on Day 22|"PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||liters per hour||Geometric Coefficient of Variation|Geometric Mean
2542571|NCT02997163|Secondary|Multiple Dose: Percentage of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24 %) of Talazoparib at Day 22|Ae 0-24% was defined as the amount of drug excreted in urine from time 0 to 24 hours, expressed as percentage of administered dose.|0 to 24 hours on Day 22|"PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||percentage of dose||Geometric Coefficient of Variation|Geometric Mean
2542572|NCT02997163|Secondary|Multiple Dose: Amount of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24%)|Ae 0-24 is the amount of drug excreted unchanged in urine from time 0 to 24 hours postdose.|0 to 24 hours on Day 22|"PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||milligram||Geometric Coefficient of Variation|Geometric Mean
2542916|NCT02989727|Primary|Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)|Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.|Six weeks||||Participants|||Count of Participants
2542573|NCT02997163|Secondary|Single Dose: Percentage of Dose of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24%) at Day 1|Ae0-24% was defined as the amount of drug excreted in urine from time 0 to 24 hours expressed as percentage of administered dose.|0 to 24 hours on Day 1|"PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||percentage of dose||Geometric Coefficient of Variation|Geometric Mean
2542574|NCT02997163|Secondary|Single Dose: Amount of Talazoparib Excreted Unchanged in Urine From Time 0 to 24 Hours (Ae 0-24)|Ae 0-24 is the amount of drug excreted unchanged in urine from time 0 to 24 hours postdose.|0 to 24 hours on Day 1|"PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||milligram||Geometric Coefficient of Variation|Geometric Mean
2542575|NCT02997163|Secondary|Multiple Dose: Unbound Apparent Oral Clearance (CLu/F) of Talazoparib|Clearance of unbound drug is a measure of the rate at which unbound drug is metabolized or eliminated by normal biological processes.|Predose, 0.5, 1, 2, 4, 6, 8-12, and 24 hours post-dose on Day 22|PK analysis population included all participants who had at least 1 reportable talazoparib concentration.|||liters per hour||Geometric Coefficient of Variation|Geometric Mean
2542576|NCT02997163|Secondary|Multiple Dose: Fraction of Unbound Drug (Fu) in Plasma in Talazoparib|Fraction of unbound drug (fu) was defined as the ratio of unbound drug concentration to the total drug concentration.|Predose, 0.5, 1, 2, 4, 6, 8-12, and 24 hours post-dose on Day 22|PK analysis population included all participants who had at least 1 reportable talazoparib concentration.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2542577|NCT02997163|Secondary|Multiple Dose: Accumulation Ratio (Rac) of AUC (0-24)|Accumulation ratio for AUC0-24 was calculated as area under the curve from time zero to 24 hours on Day 22 divided by area under the curve from time zero to 24 hours on Day 1.|Pre-dose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1 and Day 22|"PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||ratio||Geometric Coefficient of Variation|Geometric Mean
2542578|NCT02997163|Secondary|Multiple Dose: Apparent Oral Clearance (CL/F) of Talazoparib|Drug clearance is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22|PK analysis population included all participants who had at least 1 reportable talazoparib concentration.|||liters per hour||Geometric Coefficient of Variation|Geometric Mean
2542579|NCT02997163|Secondary|Multiple Dose: Plasma Trough Concentration (Ctrough) of Talazoparib|Ctrough was defined as plasma trough (predose) concentration of talazoparib.|Predose on Day 22|PK analysis population included all participants who had at least 1 reportable talazoparib concentration.|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2542580|NCT02997163|Secondary|Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib|Tmax was defined as the time to reach maximum observed plasma concentration of talazoparib.|Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22|PK analysis population included all participants who had at least 1 reportable talazoparib concentration.|||hours||Full Range|Median
2542581|NCT02997163|Secondary|Single Dose: Maximum Observed Plasma Concentration for Unbound (Cmaxu) Talazoparib|Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib.|Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1|"PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2542582|NCT02997163|Secondary|Single Dose: Area Under the Curve From Time 0 to 24 Hour for Unbound (AUC0-24u) Talazoparib|AUC0-24u for unbound talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours for unbound talazoparib.|Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1|"PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2542583|NCT02997163|Secondary|Single Dose: Fraction of Unbound Drug (Fu) in Plasma in Talazoparib|Fraction of unbound drug (fu) was defined as the ratio of unbound drug concentration to the total drug concentration.|Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1|"PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||ratio||Geometric Coefficient of Variation|Geometric Mean
2542584|NCT02997163|Secondary|Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib|Tmax was defined as the time to reach maximum observed plasma concentration of talazoparib.|Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1|PK analysis population included all participants who had at least 1 reportable talazoparib concentration.|||hours||Full Range|Median
2542585|NCT02997163|Secondary|Single Dose: Maximum Observed Plasma Concentration (Cmax) of Talazoparib|Cmax was defined as the maximum observed plasma concentration of talazoparib.|Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1|PK analysis population included all participants who had at least 1 reportable talazoparib concentration.|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2542586|NCT02997163|Secondary|Single Dose: Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24) of Talazoparib|AUC0-24 of talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours post-dose.|Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1|"PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2542587|NCT02997163|Primary|Multiple Dose: Maximum Observed Plasma Concentration for Unbound (Cmaxu) Talazoparib|Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib.|Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22|PK analysis population included all participants who had at least 1 reportable talazoparib concentration.|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2542588|NCT02997163|Primary|Multiple Dose: Area Under the Curve From Time 0 to 24 Hours for Unbound (AUC0-24u) Talazoparib|AUC0-24u for unbound talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours post-dose.|Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22|PK analysis population included all participants who had at least 1 reportable talazoparib concentration.|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2542589|NCT02997163|Primary|Multiple Dose: Maximum Observed Plasma Concentration (Cmax) of Talazoparib|Cmax was defined as the maximum observed plasma concentration of talazoparib.|Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22|PK analysis population included all participants who had at least 1 reportable talazoparib concentration.|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2542590|NCT02997163|Primary|Multiple Dose: Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24) of Talazoparib|AUC0-24 of talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours post-dose.|Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22|Pharmacokinetic (PK) analysis population included all participants who had at least 1 reportable talazoparib concentration.|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2542591|NCT02996968|Primary|Number of Participants With Postoperative Urinary Retention|"Number of Participants with postoperative urinary retention (POUR) following pelvic reconstructive surgery for pelvic organ prolapse.~Pour at 1-week was defined as continued catheterization on POD 6-8"|postoperative day 6-8||||Participants|||Count of Participants
2542592|NCT02996682|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)."|Up to Posttreatment Week 24|Full Analysis Set|||Percentage of participants|||Number
2542593|NCT02996682|Secondary|Percentage of Participants With Improved and Worsened Child-Pugh-Turcotte (CPT) Class|CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. CPT scores were calculated using prothrombin activation percentage for the coagulation parameter per Japan's standard.|Baseline to Posttreatment Week 24|Participants in the Full Analysis Set who achieved SVR24 with available data were analyzed.|||Percentage of participants|||Number
2542594|NCT02996682|Secondary|Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score|"MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. No change was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; Decrease was assigned for differences that were less than or equal to -2; and Increase was assigned for values that were greater than or equal to 2."|Baseline to Posttreatment Week 24|Participants in the Full Analysis Set who achieved SVR24 with available data were analyzed.|||Percentage of participants|||Number
2542595|NCT02996682|Secondary|Change From Baseline in HCV RNA||Baseline and up to 12 weeks|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2542596|NCT02996682|Secondary|Percentage of Participants Who Had HCV RNA < LLOQ by Visit While on Treatment||Up to 12 weeks|Participants in the Full Analysis Set with available data were analyzed.|||Percentage of participants|||Number
2542597|NCT02996682|Secondary|Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)|SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Full Analysis Set|||Percentage of participants||95% Confidence Interval|Number
2542598|NCT02996682|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||Percentage of participants||95% Confidence Interval|Number
2542599|NCT02996682|Primary|Percentage of Participants Who Discontinued Treatment (SOF/VEL or RBV) Early Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||Percentage of participants|||Number
2542600|NCT02996682|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2542601|NCT02996591|Secondary|Back Pain on POD1|Back pain (yes/no) on POD1|Postoperative day 1||||Participants|||Count of Participants
2542602|NCT02996591|Secondary|Nausea Intensity|Nausea intensity ranked on NRS score following PACU admission to 2 hours after discharge. Scored from 0-10. 0 Being no nausea, 10 being worst nausea imaginable.|2 hours after PACU admission||||score on a scale||Inter-Quartile Range|Mean
2542603|NCT02996591|Secondary|Cognitive Recovery on POD1|Postoperative Quality Recovery Scale Cognitive Domain questionnaire. Asked on postoperative day 1. Either yes (return to pre-operative cognitive function levels) or no (not yet returned to pre-operative function levels)|Postoperative day 1||||Participants|||Count of Participants
2542604|NCT02996591|Secondary|Cognitive Recovery at 2 Hours Post-operative|Postoperative Quality Recovery Scale Cognitive Domain questionnaire. Asked at 2 hour post-operatively. Either yes (return to pre-operative cognitive function levels) or no (not yet returned to pre-operative function levels)|2 hours after PACU admission||||Participants|||Count of Participants
2542605|NCT02996591|Secondary|Patient Satisfaction|Yes/no if patients would request the same anesthetic that they received|POD1||||Participants|||Count of Participants
2542917|NCT02989727|Primary|Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)|Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.|Seven weeks||||Participants|||Count of Participants
2542606|NCT02996591|Secondary|Assessment of Patient Blinding to Group Assignment|Patients will be asked whether they believe they were in the general anesthesia or spinal anesthesia group. These responses are then validated using the Bang Blinding Index, which either confirms or refutes the validity of the blinding. The scale runs from -1 to 1, with a score of 0 indicating complete blinding, -1 indicating opposite guessing of groups, and 1 indicating a complete lack of blinding.|Postoperative day 1||||Bang blinding index||95% Confidence Interval|Number
2542607|NCT02996591|Secondary|Anesthesia-related Postoperative Complications|Measuring any anesthesia-related post-op complications that occured (yes or no)|Surgery start to postoperative day 1||||Participants|||Count of Participants
2542608|NCT02996591|Secondary|Incidence of Urinary Catheterization||Duration of stay in recovery room after surgery (average 2 hours)||||Participants|||Count of Participants
2542609|NCT02996591|Secondary|Cognitive Recovery|Postoperative Quality Recovery Scale Cognitive Domain questionnaire. Asked at 1 hour post-operatively. Either yes (return to pre-operative cognitive function levels) or no (not yet returned to pre-operative function levels)|1 hour after surgery||||Participants|||Count of Participants
2542610|NCT02996591|Secondary|Opioid-Related Symptom Distress Scale (ORSDS) Score|Opioid-related symptom distress scale. The ORSDS measures patient opioid-related symptoms on a 4-point scale that evaluates 3 symptom distress dimension (severity, frequency, and bothersomeness) for 12 opioid-related symptoms. Scores range from 0-4, and the mean of the 12 answers is the ORSDS score. Higher values indicate worse opioid-related symptoms.|2 hours after surgery||||units on a scale||Standard Deviation|Mean
2542611|NCT02996591|Secondary|Non-opioid Analgesic Consumption|The number of patients who took non-opioid analgesic medication for post-operative pain between hospital discharge and postoperative day 1.|Hospital discharge to postoperative day 1||||Participants|||Count of Participants
2542612|NCT02996591|Secondary|Opioid Consumption Through First Postoperative Day. Measured in mg OME||Postoperative day 1||||mg OME||Standard Deviation|Mean
2542613|NCT02996591|Secondary|Opioid Consumption|Opioid consumption (mg OME) during inpatient stay|Duration of stay in recovery room after surgery (average 2 hours)||||mg OME||Standard Deviation|Mean
2542614|NCT02996591|Secondary|Incidence of Transient Neurologic Symptoms||Postoperative day 1 and if present, monitored until resolution||||Participants|||Count of Participants
2542615|NCT02996591|Secondary|Incidence of Post-dural Puncture Headache||Postoperative day 1 and if present, monitored until resolution||||Participants|||Count of Participants
2542616|NCT02996591|Secondary|Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)|Leiden Perioperative Care Patient Satisfaction questionnaire (LPPSq). From 1-5. 1 being not at all. 5 being extremely.|Postoperative day 1||||score on a scale||Standard Deviation|Mean
2542617|NCT02996591|Secondary|Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)|Rating the Nausea/Vomiting of patients post-operatively.|2 hours after surgery||||score on a scale||Standard Deviation|Mean
2542618|NCT02996591|Secondary|Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)|Leiden Perioperative Care Patient Satisfaction questionnaire (LPPSq) score. Performed at 1 hour postoperatively. To what degree did patients have the following symptoms. Rated 1-5, 1 being not at all. 5 being extremely.|1 hour after surgery||||score on a scale||Standard Deviation|Mean
2542619|NCT02996591|Secondary|Numerical Rating Scale Pain Scores on Postoperative Day (POD) 1|Numerical Rating Scale Pain from 0-10. 0 being no pain at all. 10 being the worst pain imaginable.|24 hours after surgery||||score on a scale||Standard Deviation|Mean
2542620|NCT02996591|Secondary|Numerical Rating Scale Pain Scores at 2 Hours Postop|Numerical rating scale pain score as reported by the patient at 2 hours post-operatively. Rated on a scale of 0 (no pain) to 10 (worst pain imaginable).|2 hours after PACU admission||||units on a scale||Standard Deviation|Mean
2542621|NCT02996591|Secondary|Numerical Rating Scale (NRS) Pain Scores at 1 Hour Postop|NRS Pain scores at 1 hour after surgery. Rated on a scale of 0 (no pain) to 10 (worst pain imaginable).|1 hour after PACU admission||||units on a scale||Standard Deviation|Mean
2542622|NCT02996591|Primary|Time Until Patient is Ready for Discharge From Post-Anesthesia Care Unit (PACU) to Home.|Modified Aldrete Scoring System and Marshall and Chung Postanesthesia Discharge Scoring System, measured in time until discharge criteria is met (in minutes)|Duration of stay in recovery room after surgery||||Minutes||Inter-Quartile Range|Mean
2542623|NCT02996500|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score at Week 12|The FACIT-F is a patient completed questionnaire consisting of 13 items that assess fatigue. Instrument scoring yields a range from 0 to 52, with higher scores representing better patient status (less fatigue). This questionnaire was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or investigator. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Baseline and Week 12|The analysis population included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (PF-06650833, tofacitinib, or placebo). It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||units on a scale||Standard Deviation|Mean
2542630|NCT02996500|Secondary|Number of Participants With Urinalysis Data Meeting Pre-specified Criteria|The urine sample was collected for central laboratory urinalysis and urine microscopy. The urinalysis included pH, protein, glucose, erythrocytes, leukocytes, ketones, nitrite, urobilinogen, urine bilirubin, urine hemoglobin, leukocyte esterase, granular casts, hyaline casts, bacteria, atypical, needle-like crystals urine, specific gravity, microscopy and urine albumin test.|Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)|The safety analysis population included all participants who received at least 1 dose of investigational drug and had evaluable urinalysis data|||Participants|||Count of Participants
2542687|NCT02994251|Secondary|Correlation Between Changes in Dynamic Contrast-enhanced MRI of Liver Lesions and Overall Survival|early changes in dynamic contrast-enhanced MRI (DCE-MRI) will correlate with long term OS, specifically as they relate to lesions targeted with cTACE therapy|18 months|Confidentiality is a concern as the study was terminated after 1 patient was enrolled, thus any reported data would indicate PHI for this subject. To prevent this, it was advised to enter 0 as the number of participants analyzed.||||||
2542624|NCT02996500|Secondary|Change From Baseline in the European Quality of Life 5 Dimensions-3 Level (EQ-5D-3L) Score at Week 12|"The EQ-5D-3L health state profile is a patient completed questionnaire designed to assess impact on health related quality of life in 5 domains: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Additionally, scores from the 5 domains might have been used to calculate a single index value, also known as a utility score. The validity and reliability of the EQ-5D-3L have been established in a number of disease states, including RA. EQ-5D-3L scores marked health status from 0 and 100. There were notes at the both ends of the scale that the bottom rate (0) corresponded to  the worst health you could imagine, and the highest rate (100) corresponded to the best health you could imagine. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints."|Baseline and Week 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||units on a scale||Standard Deviation|Mean
2542625|NCT02996500|Secondary|Change From Baseline in the Physical Component Score (PCS) and Mental Component Score (MCS) at Week 12|The SF 36 version 2 (acute) is a 36 item generic health status measure. It measures 8 general health domains. These domains can also be summarized as physical component score (PCS) and mental component score (MCS). The PCS and MCS summary scores range from 0-100, with higher scores representing better self-reported health. The lower the score the more disability. This was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or Investigator. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Baseline and Week 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||units on a scale||Standard Deviation|Mean
2542626|NCT02996500|Secondary|Change From Baseline in the 36 Item Short Form Health Survey (SF-36) Version 2 (Acute) 8 Domain Scores at Week 12|The SF-36 version 2 (acute) is a 36 item generic health status measure. It measures 8 general health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The SF-36 summary scores range from 0-100, with higher scores representing better self-reported health. This was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or Investigator. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Baseline and Week 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||units on a scale||Standard Deviation|Mean
2542627|NCT02996500|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) at Weeks 4, 8, and 12|The HAQ-DI was defined as participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Baseline, Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study and received at least 1 dose of the randomized investigational drug (PF-06650833, tofacitinib, or placebo).|||units on a scale||Standard Deviation|Mean
2542628|NCT02996500|Secondary|Change From Baseline in the Patient Global Assessment of Arthritis (PtGA) VAS at Weeks 4, 8, 12|"Patients answer the following question: Considering all the ways your arthritis affects you, how are you feeling today? The patient's response is recorded using a 100 mm VAS. This assessment was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or Investigator. The higher score indicated more severe disease. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints."|Baseline, Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||units on a scale||Standard Deviation|Mean
2542629|NCT02996500|Secondary|Change From Baseline in the Patient's Assessment of Arthritis Pain (PAAP) Visual Analogue Scale (VAS) at Weeks 4, 8, 12|Patients assess the severity of their arthritis pain using a 100 mm VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain. This assessment was performed early in the clinic visit and before the participant had extensive contact with site personnel and/or Investigator. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Baseline, Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||units on a scale||Standard Deviation|Mean
2542678|NCT02994732|Primary|Cumulative Whole Blood: Plasma Ratio Calculated for AUC0-12|AUC from time zero to the 12 hr time point with concentration above the lower limit of quantitation|Collected in 12 hrs|All enrolled subjects|||hr*ng/ml||Standard Deviation|Mean
2542679|NCT02994732|Primary|Excretion Rate of 14C-labeled BVD-523(Radioactivity in Urine)|Percent of dose excreted in urine|Collected over 15 days|All enrolled subjects|||% of radioactive dose of [14C-BVD523||Standard Deviation|Mean
2542631|NCT02996500|Secondary|Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-sepcified Criteria|ECG evaluation included: PR interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval), time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QT interval), QT interval corrected for heart rate using Fridericia's formula (QTcF interval), and QTc calculated using Bazett's correction factor (QTcB interval).|Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)|The safety analysis population included all participants who received at least 1 dose of investigational drug and had evaluable ECG data.|||Participants|||Count of Participants
2542632|NCT02996500|Secondary|Number of Participants With Vital Signs Data Meeting Pre-sepcified Criteria|Vital Signs tests included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) and pulse rate. Vital signs categorical summarization criteria were 1), systolic BP (SBP) <90 millimeters of mercury (mm Hg) or change from baseline (Chg) >=30mm Hg; diastolic BP (DBP) <50mm Hg or change from baseline >=20mm Hg; 2), pulse rate <40bpm or > 120bpm.|Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)|The safety analysis population included all participants who received at least 1 dose of investigational drug and had evaluable vital signs data.|||Participants|||Count of Participants
2542633|NCT02996500|Secondary|Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)|Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). Each parameter was evaluated against commonly used and widely accepted criteria. Clinical significance of laboratory parameters was determined at the investigator's discretion. The investigator judged the abnormality.|Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)|The safety analysis population included all participants who received at least 1 dose of investigational drug and were evaluable for laboratory abnormalities.|||Participants|||Count of Participants
2542634|NCT02996500|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment-Related TEAEs|AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator.|Baseline up to 28 calendar days after the last administration of the investigational product (about 21 months)|The safety analysis population included the participants who received at least 1 dose of the investigational drug.|||Participants|||Count of Participants
2542635|NCT02996500|Secondary|Change From Baseline in the Physician's Global Assessment of Arthritis (PhGA) at 4, 8, and 12 Weeks|"The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and was independent of the participant's reported assessments of PtGA (patient's global assessment of arthritis). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled None and the 100 mm end labeled Extreme. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints."|Baseline, Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed.It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||units on a scale||95% Confidence Interval|Least Squares Mean
2542636|NCT02996500|Secondary|Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) at 4, 8 and 12 Weeks|Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Baseline, Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||mg/dL||95% Confidence Interval|Least Squares Mean
2542637|NCT02996500|Secondary|Change From Baseline in the Tender/Painful and Swollen Joint Counts at 4, 8 and 12 Weeks|The TJC (28) included the following joints: shoulders, elbows, wrists, metatarsophalangeal (MCP) joints, PIP joints, and knees. This count was calculated from the TJC (68) assessed. The SJC (28) included the same joints as TJC (28), and was calculated from the SJC 66 assessed for swelling.Sixty eight (68) joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. The 68 joints assessed were: temporomandibular, sternoclavicular, acromioclavicular; shoulder, elbow, wrist, MCPs, thumb interphalangeal, proximal interphalangeals, and distal interphalangeals; hip, knee, ankle, tarsus, metatarsophalangeals, great toe interphalangeal, proximal and distal interphalangeals combined. Sixty-six (66) joints were assessed for swelling, the same as those listed for TJC, excluding the right and left hip joints. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Baseline, Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||joints||Standard Deviation|Mean
2542638|NCT02996500|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at 4, 8 and 12 Weeks|ACR70 was calculated as a 70% improvement in TJC and SJC and 70% improvement in 3 of the 5 remaining ACR core set measures: PtGA and PhGA, pain, disability, and an acute phase reactant which for this study was CRP or ESR. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||percentage of participants||95% Confidence Interval|Number
2542639|NCT02996500|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at 4, 8 and 12 Weeks|ACR50 was calculated as a 50% improvement in TJC and SJC and 50% improvement in 3 of the 5 remaining ACR core set measures: PtGA and PhGA, pain, disability, and an acute phase reactant which for this study was CRP or ESR. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||percentage of participants||95% Confidence Interval|Number
2542640|NCT02996500|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at 4, 8 and 12 Weeks|ACR20 was calculated as a 20% improvement in TJC and SJC and 20% improvement in 3 of the 5 remaining ACR core set measures: PtGA and PhGA, pain, disability, and an acute phase reactant which for this study was CRP or ESR. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||percentage of participants||95% Confidence Interval|Number
2542641|NCT02996500|Secondary|Change From Baseline in DAS28-3 (CRP) at 4, 8 and 12 Weeks|The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and hs-CRP. DAS28-3 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1)*1.10+ 1.15. Total score range: 0-9.4. Higher score indicated more disease activity. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Baseline, Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed.It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||units on a scale||95% Confidence Interval|Least Squares Mean
2542642|NCT02996500|Secondary|Change From Baseline in DAS28-4 (CRP) at 4, 8 and 12 Weeks|The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, hs-CRP and PtGA. DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PtGA [mm]) + 0.96. Total score range: 0-9.4. Higher score indicated more disease activity. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Baseline, Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||units on a scale||95% Confidence Interval|Least Squares Mean
2542643|NCT02996500|Secondary|Change From Baseline in DAS28-3 (ESR) at 4, 8 and 12 Weeks|The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and ESR. DAS28-3 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR) [mm/first hour]*1.08+0.16. Total score range: 0-9.4. Higher score indicated more disease activity. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Baseline, Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||units on a scale||95% Confidence Interval|Least Squares Mean
2542644|NCT02996500|Secondary|Change From Baseline in DAS28-4 (ESR) at 4, 8 and 12 Weeks|The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, ESR and PtGA. DAS28-4 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mm/first hour] + 0.014 (PtGA [mm]). Higher score indicated more disease activity. Total score range: 0-9.4. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Baseline, Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed.It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||units on a scale||95% Confidence Interval|Least Squares Mean
2542645|NCT02996500|Secondary|Percentage of Participants With DAS28-3 (CRP) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks|The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and hs-CRP. DAS28-3 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1)*1.10+1.15. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 remission was DAS28<2.6. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||percentage of participants||95% Confidence Interval|Number
2542646|NCT02996500|Secondary|Percentage of Participants With DAS28-4 (CRP) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks|The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, hs-CRP and PtGA. DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PtGA [mm]) + 0.96. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 remission was DAS28<2.6. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||percentage of participants||95% Confidence Interval|Number
2542647|NCT02996500|Secondary|Percentage of Participants With DAS28-3 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks|The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and ESR. DAS28-3 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mm/first hour]*1.08+0.16. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 remission was DAS28<2.6. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||percentage of participants||95% Confidence Interval|Number
2542648|NCT02996500|Secondary|Percentage of Participants With DAS28-4 (ESR) Remission (DAS28 <2.6) at 4, 8 and 12 Weeks|The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, ESR and PtGA. DAS28-4 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mm/first hour] + 0.014 (PtGA [mm]). Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 remission was DAS28<2.6. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||percentage of participants||95% Confidence Interval|Number
2542649|NCT02996500|Secondary|Percentage of Participants With DAS28-3 (CRP) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks|The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and hs-CRP. DAS28-3 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1)*1.10+ 1.15. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 LDAS was DAS28<3.2. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||percentage of participants||95% Confidence Interval|Number
2542650|NCT02996500|Secondary|Percentage of Participants With Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks|The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, hs-CRP and PtGA. DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PtGA [mm]) + 0.96. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 LDAS was DAS28<3.2. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||percentage of participants||95% Confidence Interval|Number
2542651|NCT02996500|Secondary|Percentage of Participants With DAS28-3 (ESR) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks|The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-3 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed and ESR. DAS28-3 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mm/first hour]*1.08+0.16. Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-3 LDAS was DAS28<3.2. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||percentage of participants||95% Confidence Interval|Number
2542652|NCT02996500|Secondary|Percentage of Participants With Disease Activity Score-28 (4 Components Based on Erythrocyte Sedimentation Rate) (DAS28-4 [ESR]) LDAS (DAS28 <3.2) at 4, 8, and 12 Weeks|The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (ESR) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, ESR and PGA. DAS28-4 (ESR) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.70 ln(ESR [mm/first hour] + 0.014 (PtGA [mm]). Total score range: 0-9.4. Higher score indicated more disease activity. The criterion of DAS28-4 (ESR) LDAS was DAS28<3.2. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||percentage of participants||95% Confidence Interval|Number
2542653|NCT02996500|Secondary|Percentage of Participants With SDAI Remission (SDAI <=3.3) at 4, 8, and 12 Weeks|The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = TJC (using 28 joints) + SJC (using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale) + hsCRP (mg/dL). The criterion of SDAI remission was SDAI<=3.3. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||percentage of participants||95% Confidence Interval|Number
2542654|NCT02996500|Secondary|Percentage of Participants With SDAI Low Disease Activity Score (LDAS) (SDAI <=11) at 4, 8, and 12 Weeks|The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = TJC (using 28 joints) + SJC (using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale) + hsCRP (mg/dL). The criterion of SDAI LDAS was SDAI<=11. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Weeks 4, 8 and 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||percentage of participants||95% Confidence Interval|Number
2542655|NCT02996500|Secondary|Change From Baseline in SDAI at Weeks 4 and 8|The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = TJC (using 28 joints) + SJC (using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale) + hsCRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity. The descriptive summary of change from baseline in SDAI was based on a mixed effect model repeat measurement MMRM model with observed data. Tofacitinib was included in this study as an active control. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Baseline, Weeks 4 and 8|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||units on a scale||95% Confidence Interval|Mean
2542656|NCT02996500|Primary|Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12|The SDAI is a continuous composite measure derived from components of the American College of Rheumatology (ACR) Core Dataset.The SDAI was calculated using the following formula: SDAI = Tender / Painful Joint Count(TJC) (using 28 joints) + Swollen Joint Count (SJC) (using 28 joints) + Patient Global Assessment of Arthritis (PtGA) (0-10 cm scale) + Physician's Global Assessment of Arthritis (PhGA) (0-10 cm scale) + high sensitivity C-reactive protein (hsCRP) (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity. The primary analysis utilized a Bayesian ANCOVA model with an informative placebo prior distribution with borrowing from tofacitinib historical placebo data. The confidence interval was credible interval in this statistical analysis. The efficacy endpoint for the tofatinicib arm was an exploratory endpoint and neither primary nor secondary endpoints.|Baseline and Week 12|The analysis population included all participants who were randomized to the study, received at least 1 dose of the randomized investigational drug (PF-06650833, or placebo), and had data collected for this outcome measure at the time points assessed. It was pre-specified in the protocol to not summarize this efficacy endpoint for Tofa arm.|||units on a scale||95% Confidence Interval|Mean
2542680|NCT02994732|Primary|Excretion Rate of 14C-labeled BVD-523(Radioactivity in Feces)|Percent of dose excreted in feces|Collected over 15 days|All enrolled subjects|||%of radioactive dose of [14C-BVD523||Standard Deviation|Mean
2542657|NCT02996097|Primary|Mean Change in Composite Patient Score for Patient and Observer Scar Assessment Scale (POSAS)|Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score.|Once every 4 weeks for 16 weeks|Analyzed 19 participants who completed the study (5 visits) in addition to the 3 participants who completed 3 of 5 visits to provide enough data for this analysis.|||score on a scale|lesions|95% Confidence Interval|Mean
2542658|NCT02996097|Primary|Mean Change in Composite Observer Score for Patient and Observer Scar Assessment Scale (POSAS)|Data from POSAS Observer Scale will be collected and reported to assess vascularity, pigmentation, thickness, relief, pliability, and surface area of the keloids chosen for the research study. Total score range: 6-60; Higher scores mean a worse outcome. Mean composite score of the final visit was compared to the mean baseline score.|Once every 4 weeks for 16 weeks|Analyzed 19 participants who completed the study (5 visits) in addition to the 3 participants who completed 3 of 5 visits to provide enough data for this analysis.|||score on a scale|lesions|95% Confidence Interval|Mean
2542659|NCT02995980|Secondary|Number of Call Backs With Contrast Mammography|•The patients identified for additional imaging based on unconfirmed findings.|1 year|Consented 128 patients, 114 patients completed both mammograms|||percentage of participants||95% Confidence Interval|Number
2542660|NCT02995980|Primary|Number of Participants With Cancer Detected|•The primary endpoint of this study is to detect the presence of cancer using DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (BI-RADS category c or d breast density).|1 year|Consented 128 patients, 114 patients completed both mammograms|||Participants|||Count of Participants
2542661|NCT02995980|Primary|Percent Accuracy of Contrast Mammography|•The primary endpoint of this study is to determine the accuracy of DE CE mammography when compared to full field digital mammography (FFDM) in patients with increased breast density (Breast Imaging-Reporting And Data System (BI-RADS) category c or d breast density).|1 year|Consented 128 patients, 114 patients completed both mammograms|||percentage of accuracy||95% Confidence Interval|Number
2542662|NCT02995967|Secondary|Quality of Life Measures|Subjective outcome at 24 weeks using the OAB-q|24 weeks|No analysis done due to study being stopped for poor enrollment||||||
2542663|NCT02995967|Secondary|Patient Satisfaction|Patient satisfaction at 12 weeks as measured using Patient Satisfaction Questionnaire (PSQ).|12 weeks|No analysis done due to study being stopped for poor enrollment||||||
2542664|NCT02995967|Secondary|Patient Impression of Improvement|Patient global impression of improvement at 12 weeks as measured using the Patient Global Impression of Improvement Questionnaire (PGI-I).|12 weeks|No analysis done due to study being stopped for poor enrollment||||||
2542665|NCT02995967|Secondary|Quality of Life Measures|Health related quality of life (HRQL) will be measured as a change from baseline at 12 weeks using the OAB-q HRQL subscale part which consists of 25 questions that assess HRQL addressing coping, concern, sleep, and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.|12 weeks|No analysis done due to study being stopped for poor enrollment||||||
2542666|NCT02995967|Secondary|Rate of UTI|Rate of urinary tract infection (UTI) as assessed by positive urine culture in patients having symptoms (dysuria, urgency, frequency, temperature ≥ 38 degrees Celcius, and/or suprapubic pain) at the 2 weeks post-operative visit. Subjects who call throughout the study complaining of symptoms but are unable to give a urine culture in clinic will also be treated and reported as having had a UTI.|2 weeks|No analysis done due to study being stopped for poor enrollment||||||
2542667|NCT02995967|Secondary|Post Void Residual Volume|Post-void residual volume (PVR) at the 2 week follow-up visit measured with catheter or bladder scan.|2 weeks|No analysis done due to study being stopped for poor enrollment||||||
2542668|NCT02995967|Secondary|Subjects Requiring Clean Intermittent Self-catheterization|Proportion of subjects requiring clean intermittent self-catheterization (CISC) post-operatively as reported at 2 week post-operative visit. CISC will be initiated at post-void residual volumes of > 300 mL or > 150 mL in the presence of bothersome retention symptoms.|2 weeks|No analysis done due to study being stopped for poor enrollment||||||
2542669|NCT02995967|Secondary|Total Number of Voids|Total number of voids reported in the 3-day bladder diary at 12 weeks as measured in change from baseline.|12 weeks|No analysis done due to study being stopped for poor enrollment||||||
2542670|NCT02995967|Secondary|Urge Urinary Incontinence Episodes|Number of UUI episodes as reported in a 3-day bladder diary at 12 weeks as measured in change from baseline.|12 weeks|No analysis done due to study being stopped for poor enrollment||||||
2542671|NCT02995967|Primary|Symptom Bother|The primary outcome will be measured as change from baseline at 12 weeks using the OAB-q bother subscale which consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.|12 weeks|No analysis done due to study being stopped for poor enrollment||||||
2542672|NCT02994979|Secondary|Number of Participants Admitted to Hospital||Up to 1 month||||Participants|||Count of Participants
2542673|NCT02994979|Secondary|Cognitive Function at 1 Month|Minimum Data Set Cognitive Performance Scale; Scale range = 0-6; Higher scores = Worse cognitive performance; Outcome measure at 1 month may be adjusted for outcome measure at baseline|Baseline and 1 month||||units on a scale||Standard Error|Mean
2542674|NCT02994979|Secondary|Physical Function at 1 Month|Minimum Data Set Activities of Daily Living scale; Scale range = 0-28; Higher score = Worse activities of daily living function; Outcome measure at 1 month may be adjusted for outcome measure at baseline|Baseline and 1 month||||units on a scale||Standard Error|Mean
2542675|NCT02994979|Primary|Number of Participants With Delirium|Confusion Assessment Method (CAM)|During acute condition, up to 3 weeks||||Participants|||Count of Participants
2542676|NCT02994732|Secondary|Treatment-related Adverse Events|Any treatment-emergent adverse events related or likely related to study treatment|27 days|All enrolled subjects|||Participants|||Count of Participants
2542677|NCT02994732|Primary|Cumulative Whole Blood: Plasma Ratio Calculated for AUC 0-24|AUC from time zero to 24 hrs|Collected in 24 hrs|All enrolled subjects|||hr*ng/ml||Standard Deviation|Mean
2542688|NCT02994251|Secondary|Correlation Between Changes in Dynamic Contrast-enhanced MRI of Liver Lesions and Progression Free Survival|early changes in dynamic contrast-enhanced MRI (DCE-MRI) will correlate with long term PFS or OS, specifically as they relate to lesions targeted with cTACE therapy|18 months|Confidentiality is a concern as the study was terminated after 1 patient was enrolled, thus any reported data would indicate PHI for this subject. To prevent this, it was advised to enter 0 as the number of participants analyzed.||||||
2542689|NCT02994251|Secondary|Toxicities of the Gemcitabine and Cisplatin Regimen in Combination With cTACE Therapy Using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.|To evaluate the toxicities of the gemcitabine and cisplatin regimen in combination with cTACE therapy in adult patients with advanced ICC. Safety will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|18 months|Confidentiality is a concern as the study was terminated after 1 patient was enrolled, thus any reported data would indicate PHI for this subject. To prevent this, it was advised to enter 0 as the number of participants analyzed.||||||
2542690|NCT02994251|Secondary|Time to Untreatable Progression (TTUP)|TTUP in liver lesions is measured from the time of initiation on cTACE therapy until radiographic evidence of disease progression in targeted lesions. Radiographic assessment will be evaluated by mRECIST using MRI every 2 cycles after intra-arterial therapy.|up to 18 months|Confidentiality is a concern as the study was terminated after 1 patient was enrolled, thus any reported data would indicate PHI for this subject. To prevent this, it was advised to enter 0 as the number of participants analyzed.||||||
2542691|NCT02994251|Secondary|Overall Time to Progression (TTP)|Overall TTP is the time from enrollment on study until radiographic evidence of overall disease progression. Radiographic assessment will be evaluated by mRECIST using MRI every 2 cycles after intra-arterial therapy.|up to 18 months|Confidentiality is a concern as the study was terminated after 1 patient was enrolled, thus any reported data would indicate PHI for this subject. To prevent this, it was advised to enter 0 as the number of participants analyzed.||||||
2542692|NCT02994251|Secondary|Overall Survival|Evaluation of overall survival (OS) of adult patients with advanced ICC treated with gemcitabine and cisplatin in combination with conventional TACE. Overall survival is the time from enrollment on study until death of the patient from any cause.|18 months|Confidentiality is a concern as the study was terminated after 1 patient was enrolled, thus any reported data would indicate PHI for this subject. To prevent this, it was advised to enter 0 as the number of participants analyzed.||||||
2542693|NCT02994251|Primary|Progression-free Survival|The primary objective of this study is to evaluate the 12-month progression-free survival (PFS) rate in adult patients with intrahepatic cholangiocarcinoma (ICC) after treatment with gemcitabine and cisplatin in combination with conventional TACE. This is the percentage of patients alive and free of progression at 12-months from enrollment on study. Radiographic assessment of disease burden will be evaluated by mRECIST and qEASL using an MRI scan obtained at the IR clinic visit.|12 months|Confidentiality is a concern as the study was terminated after 1 patient was enrolled, thus any reported data would indicate PHI for this subject. To prevent this, it was advised to enter 0 as the number of participants analyzed.||||||
2542694|NCT02994056|Secondary|Number of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit"|Baseline up to Posttreatment Week 24|Participants in the Full Analysis Set were analyzed.|||Participants|||Count of Participants
2542695|NCT02994056|Secondary|Change From Baseline in HCV RNA||Baseline; Weeks 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2542696|NCT02994056|Secondary|Absolute HCV RNA Level Through Week 12||Baseline; Weeks 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2542697|NCT02994056|Secondary|Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score|"MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. No change was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; Decrease was assigned for differences that were less than or equal to -2; and Increase was assigned for values that were greater than or equal to 2."|Baseline to Posttreatment Week 24|Participants in the Full Analysis Set who achieved SVR24 with available data were analyzed.|||percentage of participants|||Number
2542698|NCT02994056|Secondary|Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class|CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. Participants with no change CPT class was defined as having CPT Class same between Baseline and Posttreatment Week 24.|Baseline to Posttreatment Week 24|Participants in the Full Analysis Set who achieved SVR24 with available data were analyzed.|||Percentage of participants|||Number
2542699|NCT02994056|Secondary|Percentage of Participants With HCV RNA < LLOQ While on Study Treatment||Weeks 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.|||Percentage of participants||95% Confidence Interval|Number
2542700|NCT02994056|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)|SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2542701|NCT02994056|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ 4 weeks after stopping study treatment.|Posttreatment Week 4|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2542703|NCT02994056|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|The Full Analysis Set included all enrolled participants who took at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2542704|NCT02993926|Secondary|Percentage of Participants With Decease of Ratio of Bone Age to Chronological Age at the End of Follow-up Phase|Bone age (BA) was estimated using an X-ray. Chronological age (CA) at the date of corresponding X-ray (Date of X-ray - Date of birth)/365.25. Ratio of BA/CA was calculated.|No longer treated for CPP group - Month: 27 (766- 855 days) post last dose of Enantone; Treated with Non-Enantone GnRHa group - Month 18 (496-585 days) post last dose of Enantone|FAS included all enrolled participants. Number of participants analyzed is the number of male or female participants with data available for analysis of this outcome measure at the end of Follow-up Phase. There were no observations available for male participants who continued therapy with a Non-Enantone GnRHa in the follow-up period.|||percentage of participants||95% Confidence Interval|Number
2542705|NCT02993926|Secondary|Percentage of Participants With Decease of Ratio of Bone Age to Chronological Age at the End of Enantone Treatment Phase|Bone age (BA) was estimated using an X-ray. Chronological age (CA) at the date of corresponding X-ray (Date of X-ray - Date of birth)/365.25. Ratio of BA/CA was calculated.|The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months|FAS included all enrolled participants. Number of participants analyzed is the number of male or female participants with data available for analysis of this outcome measure at the end of Treatment Phase.|||percentage of participants||95% Confidence Interval|Number
2542706|NCT02993926|Secondary|Percentage of Participants With Value, for Estradiol or Testosterone, Suppressed Below Upper Limit Value (ULV) at the End of Follow-Up Phase|Estradiol or Testosterone, suppressed below Upper Limit Value (ULV) were reported. The ULV for estradiol and testosterone were 20 pg/mL and 7.34 nmol/L, respectively.|No longer treated for CPP group-Month: 27 (766-855 days) post last dose of Enantone; Treated with Non-Enantone GnRHa group-Month 21 (586-675 days) post last dose of Enantone|FAS included all enrolled participants. Number of participants analyzed is the number of male or female participants with data available for analysis of analysis at the end of Follow-up Phase. There were no observations available for male participants who continued therapy with a Non-Enantone GnRHa in the follow-up period.|||percentage of participants||95% Confidence Interval|Number
2542707|NCT02993926|Secondary|Percentage of Participants With Value, for Estradiol or Testosterone, Suppressed Below Upper Limit Value (ULV) at the End of Enantone Treatment Phase|Estradiol or Testosterone, suppressed below Upper Limit Value (ULV) were reported. The ULV for estradiol and testosterone were 20 pg/mL and 7.34 nmol/L, respectively.|The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months|FAS included all enrolled participants. Number of participants analyzed is the number of male or female participants with data available for analysis of this outcome measure at the end of Treatment Phase. There were no observations available for male participants who continued therapy with a Non-Enantone GnRHa in the follow-up period.|||percentage of participants||95% Confidence Interval|Number
2542708|NCT02993926|Secondary|Percentage of Participants With Post Stimulation Test Peak Values, for Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH), Suppressed Below Upper Limit Value (ULV) at the End of Follow-Up Phase|The LH suppression is defined as peak LH ≤2 U/L for female and peak LH ≤2.7 U/L for male. The FSH suppression is defined as peak FSH ≤6.7 U/L for female and peak FSH ≤3.7 U/L for male. Post Stimulation Test, the peak values for LH and FSH suppression below Upper Limit Value (ULV) are reported.|No longer treated for CPP group - Month: 27 (766- 855 days) post last dose of Enantone; Treated with Non-Enantone GnRHa group - Month 21 (586- 675 days) post last dose of Enantone|No data were available for this outcome measure.||||||
2542709|NCT02993926|Secondary|Percentage of Participants With Post Stimulation Test Peak Values, for Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH), Suppressed Below Upper Limit Value (ULV) at the End of Enantone Treatment Phase|The LH suppression is defined as peak LH ≤2 U/L for female and peak LH ≤2.7 U/L for male. The FSH suppression is defined as peak FSH ≤6.7 U/L for female and peak FSH ≤3.7 U/L for male. Post Stimulation Test, the peak values for LH and FSH suppression below Upper Limit Value (ULV) are reported.|The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months|FAS included all enrolled participants. Number of participants analyzed is the number of male or female participants with data available for analysis of this outcome measure at the end of Treatment Phase.|||percentage of participants||95% Confidence Interval|Number
2542710|NCT02993926|Primary|Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Follow-Up Phase|Tanner Stage is used to measure pubertal development. Female (F) and male (M) participants were evaluated for breast development and genital development respectively and both genders for pubic hair development. Tanner Stage is based on progression through 5-stages. Participants were classified as having progression if either breast/genitals or pubic hair progression were present. Otherwise participant is classified as regression or no progression.|No longer treated for CPP group - Month: 27 (766- 855 days) post last dose of Enantone; Treated with Non-Enantone GnRHa group - Month 21 (586- 675 days) post last dose of Enantone|FAS included all enrolled participants. Number of participants analyzed is the number of male or female participants with data available for analysis of this outcome measure at the end of Follow-up Phase. There were no observations available for male participants who continued therapy with a Non-Enantone GnRHa in the follow-up period.|||percentage of participants||95% Confidence Interval|Number
2542711|NCT02993926|Primary|Percentage of Participants Who Had Regression or No Progression in Tanner Staging at the End of Enantone Treatment Phase|Tanner Stage is used to measure pubertal development. Female (F) and male (M) participants were evaluated for breast development and genital development respectively and both genders for pubic hair development. Tanner Stage is based on progression through 5-stages. Participants were classified as having progression if either breast/genitals or pubic hair progression were present. Otherwise participant is classified as regression or no progression.|The mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months|Full Analysis Set (FAS) included all enrolled participants. Number of participants analyzed is the number of male or female participants with data available for the analysis of this outcome measure at the end of Treatment Phase.|||percentage of participants||95% Confidence Interval|Number
2542712|NCT02993926|Primary|Number of Participants With at Least One Treatment Emergent Adverse (TEAE) and Serious Adverse Event (SAE) During Follow-up Phase|A TEAE is any untoward medical occurrence in a subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Mean duration of follow-up=8.75 months (range: 1.9-29.5 months) for No longer treated for CPP group; 10.80 months (range: 2.8-20.5 months) for Treated with Non-Enantone GnRHa group after treatment with Enantone (while on another GnRHa)|Safety Analysis Set included all enrolled participants. Data in this outcome measure is reported separately for male and female participants for follow-up period. There were no observations available for male participants who continued therapy with a Non-Enantone GnRHa in the follow-up period.|||Participants|||Count of Participants
2542713|NCT02993926|Primary|Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) During Enantone Treatment Phase|A TEAE is any untoward medical occurrence in a subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|During treatment with and up to 30 days post last dose of Enantone (the mean duration of Enantone exposure was 22.3 months, ranging from 10.1 to 52.4 months)|Safety Analysis Set included all enrolled participants. Data in this outcome measure is reported separately for male and female participants.|||Participants|||Count of Participants
2542714|NCT02993783|Secondary|Ctrough: Trough Serum Concentrations of Vedolizumab||Day 99 (pre-dose)|Pharmacokinetic (PK) set included all participants from the safety set with at least 1 post dose PK sample collected.|||ug/mL||Standard Deviation|Mean
2542715|NCT02993783|Secondary|Number of Participants With Markedly Abnormal Vital Signs|Vital signs included heart rate, respiratory rate, systolic and diastolic blood pressure, temperature and weight. The vital sign values outside the range: systolic blood pressure (SBP) <85 mmHg and change from Baseline (BL) <=-20 mmHg, >180 mmHg and change from Baseline >=20 mmHg,diastolic blood pressure (DBP) <50 mmHg and change from Baseline <=-15 mmHg, >110 mmHg and change from Baseline >=15 mmHg, heart rate <50 beats per minute (bpm),>120 beats per minute, temperature <35.6 Degree C, >37.7 Degree C and weight change from Baseline <=-7 % and weight change from Baseline >=7 % assessed during treatment period were considered markedly abnormal.|From Baseline up to last dose of study drug (Day 99)|SAS included all participants who received any amount of the study drug.|||Participants|||Count of Participants
2542716|NCT02993783|Secondary|Number of Participants With Markedly Abnormal Laboratory Parameters Values|Clinical Laboratory parameters included tests for chemistry, hematology and urinalysis. Markedly abnormal values during treatment period were categorized as:alanine aminotransferase (ALT)>3.0 U/L*upper limit of normal(ULN),albumin<25 g/L*lower limit of normal(LLN),alkaline phosphatase >3.0 U/L*ULN,aspartate aminotransferase >3.0 U/L*ULN,bilirubin >2 umol/L*ULN,blood urea nitrogen(BUN) >10.7 mmol/L,calcium <1.75 mmol/L, >2.88 mmol/L,chloride <75 mmol/L, >126 mmol/L,creatinine >177umol/L,gamma glutamyl transferase (GGT) >3 U/L*ULN,glucose <2.8 mmol/L, >19.4 mmol/L,phosphate <0.52 mmol/L, >2.10 mmol/L,potassium<3 mmol/L, >6 mmol/L,sodium <130 mmol/L, >150 mmol/L,basophils >3(10^9/L)*ULN,eosinophils >2(10^9/L)*ULN,hematocrit (%) <0.8*LLN, >1.2*ULN,hemoglobin <0.8 g/L*LLN, >1.2 g/L*ULN,leukocytes <0.5 (10^9/L)*LLN, >1.5 (10^9/L)*ULN,lymphocytes <0.5 (10^9/L)*LLN, >1.5(10^9/L)*ULN,monocytes >2 (10^9/L)*ULN,neutrophils <0.5(10^9/L)*LLN, >1.5 (10^9/L)*ULN,platelets <75(10^9/L), >600(10^9/L).|From Baseline up to last dose of study drug (Day 99)|SAS included all participants who received any amount of the study drug.|||Participants|||Count of Participants
2542717|NCT02993783|Secondary|Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Week 32|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|From first dose of study drug to 18 weeks after last dose (Up to Week 32)|SAS included all participants who received any amount of the study drug.|||Participants|||Count of Participants
2542718|NCT02993783|Secondary|Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|From first dose of study drug to 18 weeks after last dose (Up to Week 32)|SAS included all participants who received any amount of the study drug.|||Participants|||Count of Participants
2542719|NCT02993783|Secondary|Total Dose of Steroids Administered|Total Steroids administered in mg/kg/day of methylprednisolone or equivalent|From first dose of study drug up to Months 6 and 12|Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.|||mg/kg/day||Standard Deviation|Mean
2542720|NCT02993783|Secondary|Percentage of Participants Alive Without GvHD or Primary Malignancy Relapse at Months 6 and 12||Months 6 and 12|Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.|||percentage of participants|||Number
2542721|NCT02993783|Secondary|Kaplan-Meier Estimate of Percentage of Participants Achieving Survival at Months 6 and 12|The Kaplan-Meier estimate reports the percentage of participants surviving at Months 6 and 12.|Months 6 and 12|Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
2543332|NCT02980601|Primary|Wrist Range of Motion- Extension|Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension|6 month||||degrees||Standard Deviation|Mean
2542722|NCT02993783|Secondary|Percentage of Participants With Intestinal Overall Response at Day 28|Symptoms of acute intestinal GvHD were measured using the BMT CTN-modified International Bone Marrow Transplant Registry Database (IBMTR) index. Intestinal overall response is either CR, VGPR or PR for intestine only. CR is defined as the resolution of all signs and symptoms of GvHD. VGPR is defined as resolution of the majority of signs and symptoms of intestinal GvHD: a) participant tolerates food or enteral feeding; b) predominantly formed stools; c) no overt gastrointestinal bleeding or abdominal cramping; d) no more than occasional nausea or vomiting. PR is defined as improvement of intestinal GvHD by at least 1 stage.|Day 28|Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
2542723|NCT02993783|Secondary|Percentage of Participants With Acute GvHD Complete Response (CR) at Day 28|CR is defined as the resolution of all signs and symptoms of acute GvHD.|Day 28|Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
2542724|NCT02993783|Secondary|Percentage of Participants Who Died in the Absence of Primary Malignancy Relapse After Allo-HSCT at Month 6||Month 6|Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
2542725|NCT02993783|Primary|Number of Participants Who Experienced Serious Adverse Events (SAEs) Through Day 28|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|From first dose up to Day 28|SAS included all participants who received any amount of the study drug.|||Participants|||Count of Participants
2542726|NCT02993783|Primary|Percentage of Participants With Overall Response (Partial Response [PR]+Very Good Partial Response [VGPR]+Complete Response [CR]) at Day 28|CR is defined as the resolution of all signs and symptoms of acute graft-versus-host-disease (GvHD). VGPR is defined as resolution of the signs and symptoms of the GvHD: 1) Skin: no rash, or residual erythematous rash involving <25% of the body surface, without bullae (excluding residual faint erythema and hyperpigmentation). 2) Liver: total serum bilirubin concentration <2 mg/dL or <25% of baseline at enrollment. 3) Gut: a) participant tolerates food or enteral feeding; b) predominantly formed stools; c) no overt gastrointestinal bleeding or abdominal cramping; d) no more than occasional nausea or vomiting. PR is defined as improvement of 1 GvHD stage in 1 or more organs without progression in any organ.|Day 28|Efficacy analysis set included all participants from the safety set who had baseline efficacy assessment and at least one post-baseline efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
2542727|NCT02993471|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 48 Hours (AUC[0-48h]) of CYP450 Substrate-Caffeine|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to 48 hours (AUC[0-48h]) of CYP450 Substrate (Caffeine)|Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose|All enrolled participants who received at least 1 dose of study drug with evaluable PK data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2542728|NCT02993471|Primary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Caffeine|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Caffeine)|Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose|All enrolled participants who received at least 1 dose of study drug with evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2542729|NCT02993471|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole)|Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose|All enrolled participants who received at least 1 dose of study drug with evaluable PK data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2542730|NCT02993471|Primary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Omeprazole and Its Metabolite 5-Hydroxyomeprazole|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Omeprazole and its metabolite 5-Hydroxyomeprazole)|Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours postdose|All enrolled participants who received at least 1 dose of study drug with evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2542731|NCT02993471|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Dextromethorphan|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Dextromethorphan)|Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdose|All enrolled participants who received at least 1 dose of study drug with evaluable PK data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2542732|NCT02993471|Primary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Dextromethorphan|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Dextromethorphan)|Predose, 1, 2, 4, 6, 8, 10, 24, 48, and 72 hours postdose|All enrolled participants who received at least 1 dose of study drug with evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2542733|NCT02993471|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Warfarin|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Warfarin)|Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose|All enrolled participants who received at least 1 dose of study drug with evaluable PK data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2542918|NCT02989727|Primary|Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)|Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.|Eight weeks||||Participants|||Count of Participants
2542734|NCT02993471|Primary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate-Warfarin|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of CYP450 Substrate (Warfarin)|Predose, 1, 2, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose|All enrolled participants who received at least 1 dose of study drug with evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2542735|NCT02993471|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of CYP450 Substrate-Midazolam|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC[0-∞]) of CYP450 Substrate (Midazolam)|Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose|All enrolled participants who received at least 1 dose of study drug with evaluable PK data.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2542736|NCT02993471|Primary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate-Midazolam|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Cytochrome P450 (CYP450) Substrate (Midazolam)|Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose|All enrolled participants who received at least 1 dose of study drug with evaluable PK data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2542737|NCT02993302|Primary|fT4 Levels|fT4 (free thyroxine)|1 year||||ng/dL||Standard Deviation|Mean
2542738|NCT02993302|Primary|IL-12/IL-10 Ratio|Dendritic cells maturation levels were measured by the IL-12 (interleukin-12)/IL-10 ratio|1 year||||ratio||Full Range|Median
2542739|NCT02993302|Primary|CD206 Level|Dendritic cells maturation levels were measured by the CD206|1 year||||nM||Standard Deviation|Mean
2542740|NCT02993302|Primary|CD80 Level|Dendritic cells maturation levels were measured by the CD80 (cluster of differentiation 80)|1 year||||nM||Full Range|Median
2542741|NCT02993250|Secondary|Time to Achieve HCV RNA Not Detected or HCV RNA <LLOQ|Time to Achieve HCV RNA not Detected or HCV RNA <LLOQ (15 IU/mL) was reported.|EOT up to Week 24 (follow up phase)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.|||Days||Standard Deviation|Mean
2542742|NCT02993250|Secondary|Percentage of Participants With On-treatment Virologic Response|Percentage of participants with On-treatment Virologic Response with HCV RNA < LLOQ (15 IU/mL), not detected at specified time points during treatment were reported.|Day 2, Day 3, Week 1, 2, 3, 4, 6, 8 (for Cohort 1), 10, and 12 (for Cohort 2 only)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.|||Percentage of participants|||Number
2542743|NCT02993250|Secondary|Percentage of Participants With On-treatment Failure|On-treatment failure was defined as participants who did not achieve SVR12, with confirmed HCV RNA >= LLOQ (15 IU/mL) at the actual EOT.|EOT up to Week 12 (follow up phase)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.|||Percentage of Participants|||Number
2542744|NCT02993250|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as participants who did not achieve SVR12, with HCV RNA < LLOQ (15 IU/mL) at the EOT and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up.|End of treatment up to Week 24 (follow up phase)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)] and had at least 1 postbaseline efficacy measurement in this study.|||Percentage of participants|||Number
2542745|NCT02993250|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) After Actual End-of-treatment|SVR 24 was defined as HCV RNA < LLOQ (15 IU/mL) detected or not detected at 24 weeks after the actual EOT.|Week 24 (follow-up phase)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2542746|NCT02993250|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) After Actual End-of-treatment|SVR12 was defined as HCV RNA < LLOQ (15 IU/mL) detected or not detected at 12 weeks after the actual EOT.|Week 12 (follow-up phase)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.|||Percentage of participants||95% Confidence Interval|Number
2542747|NCT02993250|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks (SVR4) After Actual End-of-Treatment|SVR4 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detected or not detected at 4 weeks after the actual End-of-treatment (EOT).|Week 4 (follow-up phase)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (that is AL-335, ODV or SMV) and had at least 1 postbaseline efficacy measurement in this study.|||Percentage of participants||95% Confidence Interval|Number
2542748|NCT02993250|Primary|Number of Participants With Adverse Events (AEs)|An adverse event was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.|Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)|The safety analysis set included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2542757|NCT02992288|Secondary|Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20|LVESV was defined as the volume of blood in the left ventricle at the end of contraction, or systole and the beginning of filling or diastole. Mean and standard deviation were reported.|Baseline, Week 20|PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline LVEF values not due to CV death or HF hospitalization or with other major protocol deviation were excluded from PPS LVEF set.|||Milliliters (mL)||Standard Deviation|Mean
2542919|NCT02989727|Primary|Hamilton Depression Rating Scale (HAMD-17) Change Scores|"Scale scores range from 0 to 52. This outcome is a change score calculated by subtracting Baseline from Week 8 scores.~Lower scores indicate greater improvement of depressive symptoms."|Eight weeks||||score on a scale||Standard Deviation|Mean
2542749|NCT02992691|Secondary|Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (Test Product 1, 2 and 3 vs Positive Control)|The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 mL of water for 10 sec,expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.|Up to 5 weeks|ITT population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.|||Score on a scale||Standard Deviation|Mean
2542750|NCT02992691|Secondary|Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (Test Product 1, 2 and 3 vs Negative Control)|The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 mL of water for 10 sec,expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth. Score range 0-5.Lower scores indicate less plaque area.|Up to 5 weeks|ITT population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.|||Score on a scale||Standard Deviation|Mean
2542751|NCT02992691|Primary|Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (TPI), Positive Control Versus [vs.] Negative Control|The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 milliliters (mL) water for 10 seconds (sec),expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth. Score range 0-5.Lower scores indicate less plaque area.|Up to 5 weeks|Intent to treat (ITT) population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.|||Score on a Scale||Standard Deviation|Mean
2542752|NCT02992288|Secondary|Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF)|Number of participants with HF hospitalization and urgent visits for HF were reported.|Baseline up to Week 26|PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.|||Participants|||Count of Participants
2542753|NCT02992288|Secondary|Number of Participants With Cardiovascular (CV) Mortality|Cardiovascular (CV) mortality was assessed. Number of participants with CV mortality were reported.|Baseline up to Week 26|PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.|||Participants|||Count of Participants
2542754|NCT02992288|Secondary|Number of Participants With Composite Efficacy Outcome|Composite efficacy outcome was the first occurrence of CV death, HF hospitalization or urgent visit for HF. Number of participants with composite efficacy outcome were reported.|Baseline up to Week 26|PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.|||Participants|||Count of Participants
2542755|NCT02992288|Secondary|Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20|High sensitivity troponin T (hs-TNT) was measured. Mean and standard deviation were reported.|Baseline, Week 20|PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.|||Picograms per milliliter (pg/mL)||Standard Deviation|Mean
2542756|NCT02992288|Secondary|Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20|LVEDV was defined as the volume of blood in the left ventricle at end load or filling in diastole or the amount of blood in the ventricles just before systole. Mean and standard deviation were reported.|Baseline, Week 20|PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline LVEF values not due to CV death or HF hospitalization or with other major protocol deviation were excluded from PPS LVEF set.|||Milliliters (mL)||Standard Deviation|Mean
2542775|NCT02991859|Secondary|Forced Expiratory Volume in 1 Second (FEV 1) in Period 2|FEV1 was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.|Day 1 (pre-dose) in Period 2|All Subjects Population.|||Liter||Standard Error|Mean
2542758|NCT02992288|Primary|Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20|NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported.|Baseline, Week 20|PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.|||log picograms per milliliter||Standard Deviation|Mean
2542759|NCT02992288|Primary|Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography|Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported.|Baseline, Week 20|Per-protocol set (PPS) included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline LVEF values not due to cardiovascular (CV) death or heart failure (HF) hospitalization or with other major protocol deviation were excluded from PPS LVEF set.|||Percentage of LVEF||Standard Deviation|Mean
2542760|NCT02992236|Secondary|Serum Creatinine Concentration||0, 2h, 4h, 6h, 8h, 10h, 24h and 48h after start of infusion||||mg/dL||Standard Deviation|Mean
2542761|NCT02992236|Primary|Glomerular Filtration Rate|by para-Amino-Hippuric Acid Clearance Method|0, 2h, 4h, 6h and 8 h after start of infusion||||mL/min||Standard Deviation|Mean
2542762|NCT02992236|Primary|Renal Plasma Flow|Renal plasma flow measurement by para-Amino-Hippuric-Acid Clearance Method|0, 2h, 4h, 6h and 8 h after start of infusion||||mL/min||Standard Deviation|Mean
2542763|NCT02992132|Secondary|Zarit Burden Interview|The Zarit Burden Interview (ZBI) assess the stresses experienced by caregivers of patients with dementia. It assesses 22 questions about the impact of the patient's disabilities on the caregiver's life, each rated from least (0) to most (4) frequent. Items are summed to calculate the ZBI total score. The ZBI total score ranges from 0 to 88; higher scores denoting more stresses experienced by caregivers.|Baseline to 12 weeks|Full Analysis set, i.e. patients who had been randomized and treated and had both a baseline value and at least 1 post-baseline value for the CMAI total score.|||score on a scale||Standard Error|Mean
2542764|NCT02992132|Primary|Cohen-Mansfield Agitation Inventory (CMAI)|The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item scale to assess agitation. Each item is rated on a 7-point scale of frequency, from least (1) to most frequent (7). Items are summed to calculate the CMAI total score. The CMAI total score has a range of 29-203 points; higher scores indicate more severe agitation|Baseline to 12 weeks|Full Analysis set, i.e. patients who had been randomized and treated and had both a baseline value and at least 1 post-baseline value for the CMAI total score.|||score on a scale||Standard Error|Mean
2542765|NCT02992119|Primary|Number of Participants Who Received RTS,S/AS01E + DHA-PIP+PQ Fractional Two-dose (Group 7) That Seroconverted at Month Two After First Dose.|The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT).(For group 7)|2 months|There were 30 subjects at group 7 received 1st vaccination and came back for follow-up at month 2 visit|||Participants|||Count of Participants
2542766|NCT02992119|Primary|Number of Participants Who Seroconverted at Month Six After First Dose.|The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT).|6 months|"Analysed subjects who returned for the month 6 follow-up.~There are 4 subjects lost follow-up as follows:~1 subject from group 1~subject from group 3~subjects from group 7"|||Participants|||Count of Participants
2542767|NCT02992119|Primary|Number of Participants Who Seroconverted One Month After the Third Dose.|The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT).|3 months||||Participants|||Count of Participants
2542768|NCT02992119|Primary|Number of Participants Who Seroconverted One Month After the Second Dose.|The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT).|2 months||||Participants|||Count of Participants
2542769|NCT02992119|Primary|Number of Participants Who Seroconverted One Month After First Dose.|The percentage of subjects seroconverting after each immunization based on a value greater than the mean titer at baseline (before immunization # 1) plus 2 standard deviations for all subjects included in the analysis (ITT).|1 months||||Participants|||Count of Participants
2542770|NCT02992119|Primary|Number of Participants Who Experience a Serious Adverse Events (SAEs) During a 6 Month Follow up Period From the Receipt of First Vaccination|Occurrence of SAEs during the whole study period, i.e. during a 6 month follow up period from the receipt of first vaccination, according to the MedRA classification.|6 months||||Participants|||Count of Participants
2542771|NCT02992119|Primary|Number of Participants Who Experience a Serious Adverse Events (SAEs) 29 Days After the Last Vaccination|Occurrence of serious adverse events (SAEs) from the date of the first vaccination to 29 days after the last vaccination, according to the MedRA classification.|29 days after last vaccination||||Participants|||Count of Participants
2542772|NCT02992067|Primary|The Accuracy of CK19 Combined With Contrast-enhanced Ultrasound (CEUS) Predicting Value on Involved Lymph Node|The accuracy means the conformity of predicting results and the pathological result in lymph node involvement and also the false negative rate of sentinel lymph node (SLN) and non-SLN (nSLN) using prediction model by CK19 combined with CEUS examination|1 year||||proportion of false negative lymphnodes|||Number
2542773|NCT02991859|Secondary|Forced Vital Capacity (FVC) in Period 2|FVC was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.|Day 1 (pre-dose) in Period 2|All Subjects Population.|||Liter||Standard Error|Mean
2542774|NCT02991859|Secondary|Forced Vital Capacity (FVC) in Period 1|FVC was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.|Day 1 (pre-dose) in Period 1|All Subjects Population.|||Liter||Standard Error|Mean
2543427|NCT02979613|Secondary|Percentage of Participants With Normal ALT at Week 96 (by Central Laboratory and the AASLD Criteria)||Week 96|||||||
2542776|NCT02991859|Secondary|Forced Expiratory Volume in 1 Second (FEV 1) in Period 1|FEV1 was measured with participants in a sitting position using a calibrated spirometer in accordance with American Thoracic Society (ATS) guidelines using European Respiratory Society (ERS)guidelines for predicted values. Results are presented treatment wise.|Day 1 (pre-dose) in Period 1|All Subjects Population.|||Liter||Standard Error|Mean
2542777|NCT02991859|Secondary|Number of Participants With Clinically Significant Abnormal Urinalysis Parameters|Urine sample were collected to assess following urine parameters: potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick. Results are presented treatment wise. Only participants with clinically significant abnormal urinalysis data was reported.|Up to Week 18|All subjects Population.|||Participants|||Count of Participants
2542778|NCT02991859|Secondary|Number of Participants With Clinically Significant Abnormal Chemistry Parameters|Blood samples were collecte for assessment of following chemistry parametres:Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), albumin, alkaline phosphatase, bilirubin, calcium, creatinine, glucose, direct bilirubin, potassium, protein, sodium, urea. Results are presented treatment wise. Only participants with clinically significant abnormal chemistry data was reported.|Up to Week 18|All subjects Population.|||Participants|||Count of Participants
2542779|NCT02991859|Secondary|Number of Participants With Clinically Significant Abnormal Hematology Parameters|Blood samples were collected for assessement of following hematology parameters: basophils, eosinophils, Erythrocyte mean corpuscular volume (MCV), hemoglobin, hematocrit, Erythrocyte mean corpuscular hemoglobin (MCH), leukocytes, lymphocytes, monocytes, platelets. Results are presented treatment wise. Only participants with clinically significant abnormal hematology data was reported.|Up to Week 18|All subjects Population.|||Participants|||Count of Participants
2542780|NCT02991859|Secondary|Number of Participants With Abnormal Physical Examination|Physical examinations included assessment of the cardiovascular, respiratory, gastrointestinal, skin, abdomen (liver and spleen), and neurological systems. This analysis was planned and data was not collected and captured in the database. Results are presented treatment wise.|Up to Week 18|All subjects Population.||||||
2542781|NCT02991859|Secondary|Number of Participants With Clinically Significant Abnormal Vital Signs: Temperature|Temperature was measured after participants have been rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.|Up to Week 18|All subjects Population.||||||
2542782|NCT02991859|Secondary|Number of Participants With Clinically Significant Abnormal Vital Signs: Respiratory Rate|Respiratory rate was measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.|Up to Week 18|All subjects Population.||||||
2542783|NCT02991859|Secondary|Number of Participants With Clinically Significant Abnormal Vital Signs: Pulse Rate|Pulse rate was measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.|Up to Week 18|All subjects Population||||||
2542784|NCT02991859|Secondary|Number of Participants With Clinically Significant Abnormal Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.|Up to Week 18|All subjects Population.||||||
2542785|NCT02991859|Secondary|Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 29 PM, Day 30, 31,32,33,34,35 AM and PM in period 2|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|||Liters per minute||Standard Error|Mean
2542786|NCT02991859|Secondary|Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 29 PM, Day 30, 31,32,33,34,35 AM and PM in period 1|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|||Liters per minute||Standard Error|Mean
2542787|NCT02991859|Secondary|Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 2|All subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Liters per minute||Standard Error|Mean
2542788|NCT02991859|Secondary|Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 1|All subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Liters per minute||Standard Error|Mean
2542789|NCT02991859|Secondary|Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 15 PM, Day 16, 17, 18, 19, 20, 21 AM and PM in period 2|All subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Liters per minute||Standard Error|Mean
2542790|NCT02991859|Secondary|Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 15,16, 17, 18, 19, 20, 21 AM and PM in period 1|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|||Liters per minute||Standard Error|Mean
2542831|NCT02991599|Secondary|Occurrence of Adverse Events After Vaccination|Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B vaccine|Within 28 days after the vaccination, at Month 0, 1, and 6|196 patients were enrolled and randomized,195 patients received the first dose, 1 patients declined in IM60 group.|||Participants|||Count of Participants
2542791|NCT02991859|Secondary|Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 8 PM, Day 9 to 14 AM and PM in period 2|All subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Liters per minute||Standard Error|Mean
2542792|NCT02991859|Secondary|Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 8 PM, Day 9 to 14 AM and PM in period 1|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|||Liters per minute||Standard Error|Mean
2542793|NCT02991859|Secondary|Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 2|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 2,3,4,5,6,7 PM in period 2|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|||Liters per minute||Standard Error|Mean
2542794|NCT02991859|Secondary|Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 1|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 2 to 6 AM and PM, Day 7 PM in period 1|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|||Liters per minute||Standard Error|Mean
2542795|NCT02991859|Secondary|Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 29 PM, Day 30,31,32,33,34,35 AM and PM in period 2|All subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Liters per minute||Standard Error|Mean
2542796|NCT02991859|Secondary|Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 29 PM, Day 30,31,32,33,34,35 AM and PM in period 1|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|||Liters per minute||Standard Error|Mean
2542797|NCT02991859|Secondary|Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 2|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|||Liters per minute||Standard Error|Mean
2542798|NCT02991859|Secondary|Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. One participant who was supposed to receive FP 1000 mg during day 22-28 and FP 2000 mg during day 28-35 but this participant continued the 3rd escalation phase dose (FP 500 mg) in fourth escalation phase and took FP 1000 mg (4th phase dose) in the fifth escalation phase (days 28-35).|Day 22 PM, Day 23,24,25,26,27,28,29,30,31,32,33,34,35 AM and PM in period 1|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|||Liters per minute||Standard Error|Mean
2542799|NCT02991859|Secondary|Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 15 PM, Day 16,17,18,19,20,21 AM and PM in period 2|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|||Liters per minute||Standard Error|Mean
2542800|NCT02991859|Secondary|Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. One participant who was supposed to receive FP 1000 mg during day 22-28 and FP 2000 mg during day 28-35 but this participant continued the 3rd escalation phase dose (FP 500 mg) in fourth escalation phase and took FP 1000 mg (4th phase dose) in the fifth escalation phase (days 28-35).|Day 15 PM, Day 16,17,18,19,20,21,22,23,24,25,26,27,28 AM and PM in period 1|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|||Liters per minute||Standard Error|Mean
2542801|NCT02991859|Secondary|PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 8,9,1,0,11,12,13,14 AM and PM in period 2|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|||Liters per minute||Standard Error|Mean
2542802|NCT02991859|Secondary|PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Days 8,9,1,0,11,12,13,14 AM and PM in period 1|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|||Liters per minute||Standard Error|Mean
2542803|NCT02991859|Secondary|PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 2,3,4,5,6,7 AM and PM in period 2|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|||Liters per minute||Standard Error|Mean
2542804|NCT02991859|Secondary|PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 1|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 2,3,4,5,6,7 PM in period 1|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|||Liters per minute||Standard Error|Mean
2542805|NCT02991859|Secondary|PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 2|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 29,30,31,32,33,34,35 PM in period 2|All subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Liters per minute||Standard Error|Mean
2542806|NCT02991859|Secondary|PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 1|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Days 29,30,31,32,33,34,35 PM in period 1|All subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Liters per minute||Standard Error|Mean
2542807|NCT02991859|Secondary|PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 2|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Days 22,23,24,25,26,27,28 PM in period 2|All subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Liters per minute||Standard Error|Mean
2542808|NCT02991859|Secondary|PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 1|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Days 22,23,24,25,26,27,28 PM in period 1|All subjects Population. Only those participants with data available at the indicated time points were analyzed.|||Liters per minute||Standard Error|Mean
2542809|NCT02991859|Secondary|PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 2|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 15,16,17,18,19,20 PM, Day 21 AM and PM in period 2|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|||Liters per minute||Standard Error|Mean
2542810|NCT02991859|Secondary|PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 1|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 15,16,17,18,19,20,21 PM in period 1|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|||Liters per minute||Standard Error|Mean
2542811|NCT02991859|Secondary|PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 2|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 8,9,10,11,12,13,14 PM in period 2|All subjects Population. Only those participants with data available at the indicated time points were analyzed|||Liters per minute||Standard Error|Mean
2542812|NCT02991859|Secondary|PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 1|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 8,9,10,11,12,13,14 PM in period 1|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|||Liters per minute||Standard Error|Mean
2542813|NCT02991859|Secondary|PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 2|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 2,3,4,5,6,7 PM in period 2|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||Liters per minute||Standard Error|Mean
2542814|NCT02991859|Secondary|PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 1|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.|Day 2,3,4,5,6,7 PM in period 1|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).|||Liters per minute||Standard Error|Mean
2542815|NCT02991859|Secondary|PEFR as a Measure of Safety and Tolerability of Placebo in Period 2|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise.|Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in Period 2|All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|||Liters per minute||Standard Error|Mean
2542816|NCT02991859|Secondary|Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1|PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise.Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).|Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in period 1|All subjects Population.|||Liters per minute||Standard Error|Mean
2542817|NCT02991859|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that at any dose results in death, Is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Results are presented treatment wise.|Up to Week 18|All Subjects Population was consisted of all participants who were randomized and who received at least one dose of trial medication.|||Participants|||Count of Participants
2542818|NCT02991859|Primary|Theraputic Index of BUD|Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by ED80 for AMP PC20 for BUD 100 mcg, BUD 400 mcg, BUD 800 mcg, BUD 1600 mcg, BUD 3200 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.|12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7|PD population. Only those participants with data available at the specified time points were analyzed.|||Ratio|||Number
2543285|NCT02981524|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Number of participants who experience treatment related adverse events ≥ grade 3 as defined by CTCAE 4.0.|up to 1 year||||Participants|||Count of Participants
2542819|NCT02991859|Primary|Theraputic Index of FP|Therapeutic Index was calculated by Dose at which 20% of the maximum effect is reached (ED20) for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by ED80 for AMP PC20 for FP 50 mcg, FP 200 mcg, FP 500 mcg, FP 1000 mcg, FP 2000 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.|12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7|PD population. Only those participants with data available at the specified time points were analyzed.|||Ratio|||Number
2542820|NCT02991859|Primary|Theraputic Index of FF|Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter[nmol/L]) divided by Dose at which 80% of the maximum effect is reached (ED80) for AMP PC20 for FF 25 mcg, FF 100 mcg, FF 200 mcg, FF 400 mcg, FF 800 mcg. Theraputic index has been presented. Only those participants with data available at the specified time points were analyzed. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.|12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7|PD population. Only those participants with data available at the specified time points were analyzed.|||Ratio|||Number
2542821|NCT02991859|Primary|Cortisol Suppression 0-24 Hours Weighted Mean-Dose Response Analysis|Blood samples for measurement of plasma cortisol were collected at given time point. The weighted means were derived by calculating the area under the curve (AUC) over the 0-24-hour period using the trapezoidal rule, and then dividing it by the actual time interval. Results are presented treatment wise. Mean and 95% CI presented are predicted estimate. The analysis method was an inhibitory exponential power-law model with log e transformed cortisol as the outcome variable, assuming 100% inhibition at highest doses.|Pre-dose PM dose on Day 6 to pre-dose PM dose Day 7|PD population. Only those participants with data available for each dose escalation phase were analyzed.|||nanomoles per liter||95% Confidence Interval|Mean
2542822|NCT02991859|Primary|Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis|The percentage fall in FEV1 was calculated using highest FEV1 (post saline) minus highest FEV1 (post AMP) divided by highest FEV1 (post saline)*100 where highest FEV1 (post saline) is the highest value of two FEV1 measurements at 60 and 180 seconds after the saline control, highest FEV1 (post AMP) is the highest value of the two FEV1 measurements at 60 and 180 seconds after the dose of AMP. Results are presented treatment wise. The analysis method was a 3 parameter Emax model with log 2 transformed AMP PC20 as the outcome variable, assuming common Emax across FF, FP and BUD, and with an unstructured variance-covariance matrix. Mean and 95% Confidence Interval (CI) presented are predicted estimate.|12 hours post last dose on Day 7|Pharmacodymanic (PD) population. Participants who were randomized and received at least one dose of trial medication and also have at least one post dose PD measurement. Only those participants with data available at the specified time points were analyzed.|||Milligrams per milliliter||95% Confidence Interval|Mean
2542823|NCT02991820|Secondary|Successful Intubation Within 120 Seconds|The number of participants who were able to successfully intubate the manikin using each device within 120 seconds.|2 minutes||||Participants|||Count of Participants
2542824|NCT02991820|Primary|Time to Endotracheal Intubation|The amount of time it took to successfully intubate the manikin using each device.|the same day (within seconds to minutes)||||seconds||Standard Deviation|Mean
2542825|NCT02991729|Secondary|Supplementary Tests Performed|Use of additional aneuploidy screening or testing modalities (cell-free DNA, chorionic villus sampling, or amniocentesis in addition to initial screening test) in the current pregnancy will be assessed up to 22 weeks gestation.|22 weeks gestation|This analysis was updated to include only invasive testing - these numbers represent those women undergoing chorionic villus sampling or amniocentesis for high risk screening results.|||Participants|||Count of Participants
2542826|NCT02991729|Secondary|Test Chosen|For participants in the intervention arm, initial choice of aneuploidy screening following use of the decision aid will be compared to final test chosen following genetic counseling.|At completion of decision aid and at completion genetic counseling, approximately 10-60 minutes|Some participants chose not to answer this question and so the numbers above reflect the number of participants for whom we have data.|||Participants|||Count of Participants
2542827|NCT02991729|Secondary|Decisional Conflict Score|A low-literacy decisional conflict questionnaire will be used. This will be completed by patients in the intervention arm following use of the decision and and again following genetic counseling. It will be completed by patients in the routine care arm following genetic counseling. Decisional conflict at all time points will be compared - specifically, decisional conflict following decision aid completion in the Experimental Group will be compared to decisional conflict following genetic counseling in the Routine Care Group, and decisional conflict following both decision aid completion and genetic counseling in the Experimental Group will be compared to decisional conflict following genetic counseling in the Routine Care Group. This questionnaire is on a 40 point scale (values 0-40), with higher score indicating higher level of decisional conflict.|At completion of genetic counseling, approximately 10-60 minutes||||score on a scale||Standard Deviation|Mean
2542828|NCT02991729|Primary|Knowledge Score|All patients in the intervention arm will complete a knowledge questionnaire following completion of the decision and and again immediately following genetic counseling. The investigators will assess noninferiority of the decision aid on participant knowledge, with primary outcome comparing knowledge after completion of the decision aid in the intervention arm, to knowledge following genetic counseling only in the routine care arm. The questionnaire is a modification of the validated Maternal Serum Screening Knowledge Questionnaire. This is on a 12-point scale (values 0-12), with higher score indicating greater knowledge.|At completion of genetic counseling for the Routine Care Group and at completion of decision aid and genetic counseling for Experimental Group, approximately 10-60 minutes||||score on a scale||Standard Deviation|Mean
2542829|NCT02991599|Other Pre-specified|Number and Rate of Participants With Anti-HBs High-level Response at Month 12|The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/mL were high-level response.|Month 12|60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12.|||Participants|||Count of Participants
2542830|NCT02991599|Other Pre-specified|Number and Rate of Participants With Anti-HBs High-level Response at Month 7|The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.|Month 7|73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7.|||Participants|||Count of Participants
2542833|NCT02991599|Secondary|Number and Rate of Participants With Anti-HBs Seroconversion at Month 12|"The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）~. The accepted protective serum anti-HBs level was ≥10 mIU/ml"|Month 12|60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12.|||Participants|||Count of Participants
2542834|NCT02991599|Secondary|Anti-HBs Concentration at Month 12|The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）|Month 12|60 and 61 patients in the IM20 and IM60 groups completed the followed-up at months 12.|||mIU/mL||95% Confidence Interval|Mean
2542835|NCT02991599|Secondary|Anti-HBs Concentration at Month 7|The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）|Month 7|73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7 .|||mIU/mL||95% Confidence Interval|Mean
2542836|NCT02991599|Primary|Number and Rate of Participants With Anti-HBs Seroconversion at Month 7|"The measurements of anti-HBs antibodies were determined quantitatively by CMIA（ Chemiluminescent Microparticle Immunoassay ）~. The accepted protective serum anti-HBs level was ≥10 mIU/ml."|Month 7|73 and 71 patients in the IM20 and IM60 groups completed the followed-up at months 7.|||Participants|||Count of Participants
2542837|NCT02991430|Secondary|Sustained Reduction in Migraine Headache Days|comparison of MHD recorded in baseline month versus post-treatment months 7, 8 and 9|1 month of baseline recordation followed by 252 days of device use|The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE’s were reported over the course of the Study.||||||
2542838|NCT02991430|Secondary|Additional Treatment Time|comparison of MHD recorded in baseline month versus 6th month of treatment|1 month of baseline recordation followed by 168 days of device use|The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE’s were reported over the course of the Study.||||||
2542839|NCT02991430|Secondary|Change in Sleep Quality|comparison of Pittsburgh Sleep assessment scores between baseline month and treatment month 3|1 month of baseline recordation followed by 84 days of device use|The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE’s were reported over the course of the Study.||||||
2542840|NCT02991430|Secondary|Change in Anxiety|comparison of BAI (Beck anxiety index) scores between baseline month and treatment month 3|1 month of baseline recordation followed by 84 days of device use|The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE’s were reported over the course of the Study.||||||
2542841|NCT02991430|Secondary|Change in Depression|comparison of BDI-II (Beck depression index) scores between baseline month and treatment month 3|1 month of baseline recordation followed by 84 days of device use|The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE’s were reported over the course of the Study.||||||
2542842|NCT02991430|Secondary|Change in Quality of Life|comparison of HIT-6 (headache impact test) scores between baseline month and treatment month 3|1 month of baseline recordation followed by 84 days of device use|The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE’s were reported over the course of the Study.||||||
2542843|NCT02991430|Secondary|Change in Headache Pain|reduction in subject perceived headache pain scores in month 3 of treatment versus baseline month|1 month of baseline recordation followed by 84 days of device use|The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE’s were reported over the course of the Study.||||||
2542844|NCT02991430|Secondary|Change in Medication Usage|reduction in acute, prescribed medications in month 3 of treatment versus baseline month|1 month of baseline recordation followed by 84 days of device use|The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE’s were reported over the course of the Study.||||||
2542845|NCT02991430|Secondary|Normalized Reduction in Migraine Headache Days|comparison of MHD recorded in baseline month versus 3rd month of treatment: percentages, active versus placebo|1 month of baseline recordation followed by 84 days of device use|The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE’s were reported over the course of the Study.||||||
2542846|NCT02991430|Primary|Change in Migraine Headache Days (MHD)|comparison of MHD recorded in baseline month versus 3rd month of treatment|1 month of baseline recordation followed by 84 days of device use|The majority of devices failed in the field, preferentially affecting the active arm/group. As a result, data collection was compromised due to the frequent device failures and thus the results are not reported. No significant device related AE’s were reported over the course of the Study.||||||
2542847|NCT02991118|Other Pre-specified|Change From Baseline to Week 52 in LDL-C|Baseline was defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Change from Baseline is calculated as the post-baseline value minus the baseline value. Analysis was conducted using descriptive statistics by treatment group using observed data. Change from Baseline in LDL-C was analyzed using an ANCOVA model with change from baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and baseline as a covariate.|Baseline; Week 52|Full Analysis Set. Only participants with available data were analyzed.|||mg/dL||Standard Error|Least Squares Mean
2542848|NCT02991118|Other Pre-specified|Percent Change From Baseline to Week 52 in hsCRP|Baseline for hsCRP was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100.|Baseline; Week 52|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Inter-Quartile Range|Median
2542849|NCT02991118|Other Pre-specified|Percent Change From Baseline to Week 24 in hsCRP|Baseline for hsCRP was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100.|Baseline; Week 24|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Inter-Quartile Range|Median
2542850|NCT02991118|Other Pre-specified|Percent Change From Baseline to Week 52 in Apo B|Baseline for apo B was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in apo B was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.|Baseline; Week 52|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Standard Error|Least Squares Mean
2542851|NCT02991118|Other Pre-specified|Percent Change From Baseline to Week 24 in Apo B|Baseline for apo B was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in apo B was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.|Baseline; Week 24|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Standard Error|Least Squares Mean
2542852|NCT02991118|Other Pre-specified|Percent Change From Baseline to Week 52 in TC|Baseline was defined as the mean of the TC values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in TC was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.|Baseline; Week 52|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Standard Error|Least Squares Mean
2542853|NCT02991118|Other Pre-specified|Percent Change From Baseline to Week 24 in TC|Baseline was defined as the mean of the TC values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in TC was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.|Baseline; Week 24|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Standard Error|Least Squares Mean
2542854|NCT02991118|Other Pre-specified|Percent Change From Baseline to Week 52 in Non-HDL-C|Baseline was defined as the mean of the non-HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.|Baseline; Week 52|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Standard Error|Least Squares Mean
2542855|NCT02991118|Other Pre-specified|Percent Change From Baseline to Week 24 in Non-HDL-C|Baseline was defined as the mean of the non-HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.|Baseline; Week 24|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Standard Error|Least Squares Mean
2542856|NCT02991118|Other Pre-specified|Percent Change From Baseline to Week 52 in LDL-C|Baseline was defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in LDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.|Baseline; Week 52|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Standard Error|Least Squares Mean
2542857|NCT02991118|Other Pre-specified|Percent Change From Baseline to Week 12 in HDL-C|Baseline is defined as the mean of the HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.|Baseline; Week 12|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Standard Error|Least Squares Mean
2542868|NCT02991040|Secondary|Investigator Global Aesthetic Improvement|Investigator Global Aesthetic Improvement Score is a 5-point scale with 1 = Worse (worst outcome); 2 = No Change; 3 = Improved; 4 = Much Improved, 5 = Very much improved (best outcome). The higher scores mean a better outcome.|Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)|mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face|||score on a scale||Standard Deviation|Mean
2542858|NCT02991118|Other Pre-specified|Percent Change From Baseline to Week 12 in Triglycerides (TGs)|Baseline is defined as the mean of the TG values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in TG was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.|Baseline; Week 12|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Standard Error|Least Squares Mean
2542859|NCT02991118|Secondary|Change From Baseline to Week 24 in LDL-C|Baseline is defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Change from Baseline is calculated as the post-baseline value minus the baseline value. Analysis was conducted using descriptive statistics by treatment group using observed data.|Baseline; Week 24|Full Analysis Set. Only participants with available data were analyzed.|||mg/dL||Standard Deviation|Mean
2542860|NCT02991118|Secondary|Change From Baseline to Week 12 in LDL-C|Baseline is defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Change from Baseline is calculated as the post-baseline value minus the baseline value. Analysis was conducted using descriptive statistics by treatment group using observed data.|Baseline; Week 12|Full Analysis Set. Only participants with available data were analyzed.|||mg/dL||Standard Deviation|Mean
2542861|NCT02991118|Secondary|Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)|Baseline for hsCRP was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100.|Baseline; Week 12|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Inter-Quartile Range|Median
2542862|NCT02991118|Secondary|Percent Change From Baseline to Week 12 in Apolipoprotein b (Apo B)|Baseline for apo B was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in apo B was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing apo B data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.|Baseline; Week 12|Full Analysis Set: all randomized participants|||percent change||Standard Error|Least Squares Mean
2542863|NCT02991118|Secondary|Percent Change From Baseline to Week 12 in Total Cholesterol (TC)|Baseline is defined as the mean of the TC values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in TC was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing TC data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.|Baseline; Week 12|Full Analysis Set: all randomized participants|||percent change||Standard Error|Least Squares Mean
2542864|NCT02991118|Secondary|Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)|Baseline is defined as the mean of the non-HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing non-HDL-C data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.|Baseline; Week 12|Full Analysis Set: all randomized participants|||percent change||Standard Error|Least Squares Mean
2542865|NCT02991118|Secondary|Percent Change From Baseline to Week 24 in LDL-C|Baseline is defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in LDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing LDL-C data at Week 24 were imputed using multiple imputation method taking into account adherence to treatment.|Baseline; Week 24|Full Analysis Set: all randomized participants|||percent change||Standard Error|Least Squares Mean
2542866|NCT02991118|Primary|Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)|Baseline is defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. Percent change from Baseline in LDL-C was analyzed using an analysis of covariance (ANCOVA) model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (atherosclerotic cardiovascular diseases [ASCVD] and heterozygous familial hypercholesterolemia [HeFH]) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing LDL-C data at Week 12 are imputed using multiple imputation method taking into account adherence to treatment.|Baseline; Week 12|Full Analysis Set: all randomized participants|||percent change||Standard Error|Least Squares Mean
2542867|NCT02991040|Other Pre-specified|Safety and Tolerability of Revanesse Ultra and Revanesse Ultra+ Injection by Incidence of Treatment Emergent Adverse Events|study products will be compared by evaluating the nature, severity, and frequency of treatment-emergent adverse events (TEAEs)|at injection, Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)|ITT (safety population): All randomized subjects who received study product|||events|||Number
2542903|NCT02989727|Primary|Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)|Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.|One week||||Participants|||Count of Participants
2542869|NCT02991040|Secondary|Patient Global Aesthetic Improvement|Patient Global Aesthetic Improvement Score is a 5-point scale used to assess the subject's satisfaction with the visual appearance of their NLF correction after treatment. 1 = Worse (worst outcome), 2 = No Change, 3 = Improved, 4 = Much Improved, 5 = Very Much improved (best outcome). The higher scores mean a better outcome.|Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)|mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face.|||score on a scale||Standard Deviation|Mean
2542870|NCT02991040|Secondary|Wrinkle Severity Rating Score (WSRS)|The Wrinkle Severity Rating Scale is a 5-point scale with 1 = Absent; 2 = Mild; 3 = Moderate; 4 = Severe and 5 = Extreme. 1 is the best outcome while 5 is the worst outcome. The higher scores mean a worse outcome.|Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)|mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face.|||Wrinkle Severity Rating scale||Standard Deviation|Mean
2542871|NCT02991040|Secondary|Pain Measured by Subject on 100 mm VAS Scale at 15, 30, 45, and 60 Minutes Post Injection and at 2 Weeks Post Injection|Visual Analog Scale for pain. A 100 mm scale with 0 mm being no pain (best outcome) to 100 mm being worst pain (worst outcome). The higher score means a worse outcome.|15, 30, 45, and 60 minutes post injection and at 2 weeks post injection|mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face|||VAS score||Standard Deviation|Mean
2542872|NCT02991040|Primary|Pain at Injection as Measured by Subject on a 100 mm Visual Analog Scale (VAS) Scale at Time 0 Minutes Post Injection|Visual Analog Scale for Pain. A 100 mm scale with 0 mm being no pain (best outcome) to 100 mm being worst pain (worst outcome). The higher scores mean a worse outcome|at injection Time 0|mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face|||VAS||Standard Deviation|Mean
2542873|NCT02990910|Secondary|Median Survival Time of the East Ontario Children's Hospital Pain Score (CHEOPS)> 6 in the Two Groups.|Pain was assessed and recorded through the East Ontario children's hospital pain score (CHEOPS).When the CHEOPS>6,We thought it is painful. Comparing the median survival time (the time corresponding to pain percentage of 50% in two groups)of CHEOPS＞6 in two groups.|Time from entering the PACU until the patient leaves,approx 1 hour.||||minute||95% Confidence Interval|Median
2542874|NCT02990910|Primary|Number of Participants With Respiratory Adverse Events in PACU(Postanesthesia Care Unit).|The main observation indexes was the incidence of respiratory adverse events in PACU, the ratio was the number of children who occurred respiratory adverse events to the total number of children. Respiratory adverse events were defined as an intervention requiring a nurse to maintain the SPO2 ≥95%.|Time from entering the PACU until the patient leaves,approx 1 hour.||||Participants|||Count of Participants
2542875|NCT02990338|Secondary|Number of Participants With Minimal Residual Disease (MRD)|MRD was assessed by next-generation sequencing in bone marrow samples from participants who achieved CR, to determine the depth of response at the molecular level. IMWG criteria for CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow aspirates. MRD was classified as positive or negative at the minimum sensitivity of 1 in 10^5 nucleated cells. MRD negativity was defined as the absence of the dominant clonotype sequence(s) identified in the bone marrow aspirate collected at screening. MRD positivity was defined as the presence of the dominant clonotype sequence(s) identified in the bone marrow aspirate collected at screening.|Up to 76.7 weeks|Analysis was performed on ITT population who were evaluable for MRD.|||Participants|||Count of Participants
2542876|NCT02990338|Secondary|Time to Best Response (TTBR)|TTBR was defined as the time from randomization to the date of first occurrence of IRC determined BOR (PR or better) that was subsequently confirmed. PR was defined as >=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >=90% or to <200 mg/24 h. In addition to the above listed criteria, if present at baseline, a >=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required. BOR was defined as the best sequential response, using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first.|From the date of randomization to date of first occurrence of IRC determined best overall response or data cut-off whichever comes first (maximum duration 76.7 weeks)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
2542877|NCT02990338|Secondary|Time to First Response (TT1R)|TT1R was defined as the time from randomization to the date of first IRC determined response (PR or better) that is subsequently confirmed. PR was defined as >=50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >=90% or to <200 mg/24 h. In addition to the above listed criteria, if present at baseline, a >=50% reduction in the size (SPD) of soft tissue plasmacytomas was also required.|From the date of randomization to the date of first IRC determined response, or death or data cut-off whichever comes first (maximum duration 76.7 weeks)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
2542878|NCT02990338|Secondary|Percentage of Participants With Very Good Partial Response (VGPR)|VGPR rate was defined as the percentage of participants achieving a VGPR or better as BOR. VGPR was defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg/24 h or >=90% decrease in the sum of maximal perpendicular diameter compared to baseline in soft tissue plasmacytoma. BOR was defined as the best sequential response (CR), using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates.|From the date of randomization to the date of first documentation of progression, death, initiation of further anti-myeloma treatment, or data cut-off whichever comes first (maximum duration 76.7 weeks)|Analysis was performed on ITT population.|||percentage of participants|||Number
2542879|NCT02990338|Secondary|Clinical Benefit Rate (CBR): Percentage of Participants With Clinical Benefit|CBR was defined as the percentage of participants achieving a MR or better as BOR. MR was defined as >= 25% but <= 49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%, which still exceed 200 mg/24h; if present at baseline, >=50% reduction in size (SPD) of soft tissue plasmacytomas was also required. BOR was defined as the best sequential response, using the IRC's assessment of response, from the start of treatment until disease progression (provided that the progression is subsequently confirmed in case of progression requiring confirmation), death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first.|From the date of randomization to the date of first documentation of progression, death, initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)|Analysis was performed on ITT population.|||percentage of participants|||Number
2542880|NCT02990338|Secondary|Percentage of Participants With Best Overall Response (BOR)|BOR:best sequential response from start of treatment until disease progression,death, initiation of further anti-myeloma treatment/data cut-off, whichever comes first. Ordering of evaluations from best to worse was: sCR,CR,VGPR,PR, minimal response(MR), stable disease(SD),PD, and not evaluable.CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates. sCR:CR as defined previously plus normal FLC ratio (0.26 to 1.65),absence of clonal cells in bone marrow biopsy. VGPR: serum and urine M-protein detectable by immunofixation,>=90% reduction in serum M-protein plus urine M-protein level <100mg/24h,>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR: >=50% reduction of serum M-protein and reduction in 24h urinary M-protein by >=90%/<200mg/24h. MR:>=25% but <=49% reduction in serum M-protein and reduction in 24h urine M-protein by 50-89%. SD: Not meeting criteria for CR,VGPR,PR,MR/PD.|From the date of randomization until disease progression, or death, initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)|Analysis was performed on ITT population.|||percentage of participants|||Number
2542881|NCT02990338|Secondary|Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS)|EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state utility index (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.|Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)|Analysis was performed on safety population evaluable for visual analogue scale. Here, ‘Number analyzed’ = participants with available data for each specified category.|||centimeter||Standard Deviation|Mean
2542882|NCT02990338|Secondary|Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions (5D), 5 Levels (5L) (EQ-5D-5L) Score: Health State Utility Index Value|The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health and wellbeing. The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale (for the 5L version). The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state.|Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)|Analysis was performed on safety population evaluable for health state utility index. Here, ‘Number analyzed’ = participants with available data for each specified category.|||score on a scale||Standard Deviation|Mean
2542883|NCT02990338|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment Domain Score|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Side effects of treatment domain is one of the four domain scores. Side effects of treatment domain score used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale, where higher scores = more side effects and lower HRQL and lower scores = less side effects and better HRQL.|Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)|Analysis was performed on safety population evaluable for side effects of treatment. Here, ‘Number analyzed’ = participants with available data for each specified category.|||score on a scale||Standard Deviation|Mean
2542884|NCT02990338|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20): Disease Symptoms Domain Score|EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Disease symptoms domain is one of the four domain scores. Disease symptoms domain score used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0 -100 scale, where higher scores = more symptoms and lower health-related quality of life (HRQL) and lower score = less symptoms and more HRQL|Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)|Analysis was performed on safety population evaluable for disease symptoms. Here, ‘Number analyzed’ = participants with available data for each specified category.|||score on a scale||Standard Deviation|Mean
2542885|NCT02990338|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 30 Items (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QOL) Score|EORTC-Quality of Life Questionnaire (QLQ)-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. EORTC QLQ-C30 included GHS/ QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.|Baseline, Day 1 of each cycle (Cycle 3, Cycle 6, Cycle 9, and Cycle 17)|Analysis was performed on safety population evaluable for global health status. Here, ‘Number analyzed’ = participants with available data for each specified category.|||score on a scale||Standard Deviation|Mean
2542886|NCT02990338|Secondary|Number of Participants With Anti-drug Antibodies (ADA)|ADA were categorized as: pre-existing, treatment induced and treatment boosted response. Pre-existing ADA was defined as ADA that were present in samples drawn during the pretreatment period (i.e., before the first isatuximab administration). Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without preexisting ADA, including participants without pretreatment samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment and post-treatment.|From randomization up to 60 days after last dose of study drug (maximum duration 76.7 weeks)|Analysis was performed on ADA evaluable population which included participants who received at least one dose of study drug from the IPd arm with at least one ADA assessment during the ADA on-study observation period with a reportable result.|||Participants|||Count of Participants
2542887|NCT02990338|Secondary|PK Parameter: Accumulation Ratio of Isatuximab at Trough Concentration (Ctrough)|Accumulation Ratio was defined as the ratio of Ctrough of Cycle 2 Day 1 versus Cycle 1 Day 8 and Cycle 4 Day 1 versus Cycle 1 Day 8, where Ctrough is the concentration prior to study drug administration.|Pre-infusion on Cycle 1 Day 8, Cycle 2 Day 1, and Cycle 4 Day 1|Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2542888|NCT02990338|Secondary|PK Parameter: Plasma Concentration of Isatuximab at Ctrough|Trough Concentration (Ctrough) is the concentration prior to study drug administration.|Pre-infusion on C1D1, C1D8, C1D15, C1D22, C2D1, C2D15, C3D1, C3D15, C4D1, C4D15, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1; End of treatment (EOT[30 days after last drug administration])|Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2542889|NCT02990338|Secondary|Pharmacokinetic Parameter: Plasma Concentration of Isatuximab at 1 Hour After End of Infusion (CEOI+1 Hour)|CEOI+1 hour was defined as the plasma concentration of isatuximab at 1 hour after end of infusion.|Cycle 1:1 hour after End of Infusion on Day 1; Cycle 4:1 hour after End of Infusion on Day 1|Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2542890|NCT02990338|Secondary|Pharmacokinetic Parameter: Accumulation Ratio of Isatuximab at Concentration at the End of Infusion (CEOI)|Accumulation Ratio was defined as the ratio of CEOI of Cycle 2 Day 1 versus Cycle 1 Day 1 and Cycle 4 Day 1 versus Cycle 1 Day 1, where CEOI was the plasma concentration at the end of infusion.|End of infusion on Cycle 1 Day 1, Cycle 2 Day 1, and Cycle 4 Day 1|Analysis was performed on PK population. Here, 'Number analyzed' = participants with available data for each specified category.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2542891|NCT02990338|Secondary|Pharmacokinetics (PK) Parameter: Plasma Concentration of Isatuximab at End of Infusion (CEOI)|CEOI was defined as the plasma concentration at end of infusion.|End of infusion on Cycle(C)1 Day(D)1 and Cycle1 Day 15; Cycle 2 Day 1; and Cycle 4 Day 1|Analysis was performed on PK population which included participants who received at least 1 dose of Isatuximab, with data for at least 1 PK parameter available. Here, ‘Number analyzed’ = participants with available data for each specified category.|||microgram per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2542892|NCT02990338|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. TEAEs were defined as AEs that developed, worsened (according to the Investigator opinion), or became serious during the treatment period (time from the first dose of study treatments up to 30 days after last dose of study treatments). An SAE is any untoward medical occurrence that at any dose: results in death, Is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect, is a medically important event.|From randomization up to 30 days after last dose of study drug (maximum duration 76.7 weeks)|Analysis was performed on safety population which included all participants from the ITT population who received at least one dose or a part of a dose of the study treatments.|||Participants|||Count of Participants
2542893|NCT02990338|Secondary|Duration of Response (DOR)|DOR:time from date of first IRC determined response(PR or better) to date of first IRC-PD or death, whichever occurred first.DOR was determined only for participants who had achieved a response of PR or better based on disease assessment by IRC.If progression or death was not observed,participant was censored at date of participants last progression-free tumor assessment prior to initiation of further anti-myeloma treatment(if any)and study cut-off date. PD(IMWG criteria):increase of >=25% from lowest confirmed value in any one of following criteria: serum M-protein (absolute increase must be >=0.5 g/dL), serum M-protein increase >=1g/dL if lowest M component was >=5g/dL;urine M-component (absolute increase must be >=200mg/24 hour),appearance of new lesion(s), >=50% increase from nadir in SPD of >1 lesion,or >=50% increase in the longest diameter of a previous lesion >1 cm in short axis. PR:>=50% reduction of serum M-protein and reduction in 24h urinary M-protein by >=90%/<200mg/24h.|From the date of the first IRC determined response to the date of first IRC progression or death, whichever occurred first (maximum duration 76.7 weeks)|Analysis was performed on responders in ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2542904|NCT02989727|Primary|Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)|Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.|Two weeks||||Participants|||Count of Participants
2542905|NCT02989727|Primary|Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)|Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.|Three weeks||||Participants|||Count of Participants
2542906|NCT02989727|Primary|Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)|Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.|Four weeks||||Participants|||Count of Participants
2542907|NCT02989727|Primary|Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)|Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.|Five weeks||||Participants|||Count of Participants
2542894|NCT02990338|Secondary|Progression Free Survival in High Risk Cytogenetic Population|PFS in high risk cytogenetic population was defined as PFS in subgroup of participants carrying high risk cytogenetic changes including del(17p), translocation (t)(4;14) or translocation t(14;16) assessed by fluorescence in situ hybridization (FISH). PFS was defined as the time from date of randomization to date of first documentation of PD (determined by IRC) or date of death from any cause, whichever comes first. PD defined as per IMWG criteria as: increase of >=25% from lowest confirmed value in any one of following criteria: serum M-protein (absolute increase must be >=0.5 g/dL), serum M-protein increase >=1 g/dL if lowest M component was >=5 g/dL; urine M-component (absolute increase must be >=200 mg/24hour), appearance of new lesion(s), >=50% increase from nadir in SPD of >1 lesion, or >=50% increase in the longest diameter of previous lesion >1 centimeter (cm) in short axis.|From the date of randomization to the date of first documentation of progression, or the date of death from any cause, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)|Analysis was performed in high-risk cytogenetic population which included participants carrying del (17p), t(4;14) or t(14;16) in each arm.|||months||95% Confidence Interval|Median
2542895|NCT02990338|Secondary|Time to Progression (TTP)|TTP was defined as time from randomization to the date of first documentation of PD, as determined by the IRC. As per IMWG criteria, PD was defined for participants with increase of >= 25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute increase must be >= 0.5 g/dL), serum M-protein increase >=1 g/dL if the lowest M component was >=5 g/dL; urine M-component (the absolute increase must be >=200 mg/24hour), appearance of new lesion(s), >=50% increase from nadir in SPD of >1 lesion, or >=50% increase in the longest diameter of a previous lesion >1 centimeter in short axis.|From the date of randomization to the date of first documentation of progression, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
2542896|NCT02990338|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to death from any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive or at the cut-off date, whichever comes first.|From the date of randomization to date of death from any cause or study cut-off date, whichever was earlier (maximum duration 76.7 weeks)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
2542897|NCT02990338|Secondary|Overall Response Rate (ORR): Percentage of Participants With Overall Response|ORR:percentage of participants with stringent complete response(sCR), complete response(CR), very good partial response(VGPR), and partial response(PR) as best overall response, assessed by IRC using IMWG criteria. sCR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates plus normal free light chain(FLC)ratio(0.26-1.65), absence of clonal cells in bone marrow biopsy.CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates.VGPR: serum and urine M-protein detectable by immunofixation, not on electrophoresis/,>=90% reduction in serum M-protein plus urine M-protein level <100mg/24h/,>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR: >=50% reduction of serum M-protein and reduction in 24h urinary M-protein by >=90%/<200mg/24h,if present at baseline,>=50% reduction in the size(SPD) of soft tissue plasmacytomas.|From the date of randomization to the date of first documentation of progression or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)|Analysis was performed on ITT population.|||percentage of participants|||Number
2542898|NCT02990338|Primary|Progression Free Survival (PFS)|PFS:time from date of randomization to date of first documentation of progressive disease (PD) determined by Independent Response Committee (IRC) or date of death from any cause, whichever comes first. If progression or death was not observed, participant was censored at date of last progression-free tumor assessment prior to study cut-off date. Analysis was performed by Kaplan-Meier method. PD as per International Myeloma Working Group (IMWG) criteria was defined as increase of >=25% from lowest confirmed value in any one of the following criteria: serum M-protein (the absolute increase must be >=0.5gram(g)/dL), serum M-protein increase >=1g/dL if lowest M component was >=5g/dL; urine M-component (absolute increase must be >=200mg/24hour), appearance of new lesion(s),>=50% increase from nadir in sum of the products of the maximal perpendicular diameters of measured lesions (SPD) of >1 lesion, or >=50% increase in the longest diameter of a previous lesion >1 centimeter in short axis.|From the date of randomization to the date of first documentation of progression, or the date of death from any cause, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration: 76.7 weeks)|Analysis was performed on Intent-to-treat (ITT) population which included all randomized participants.|||months||95% Confidence Interval|Median
2542899|NCT02989805|Secondary|Number of Participants Being Admitted for Inpatient Hospitalization|The number of inpatient hospitalizations, for mental health problems as well as all cause patient admissions, is presented here.|6 months after discharge|This analysis includes participants for whom the 6-month follow-up data were available.|||Participants|||Count of Participants
2542900|NCT02989805|Secondary|Number of Participants Being Readmitted to the Emergency Room|The number of emergency room readmissions, for mental health/substance use and all-cause emergency room visits, is presented here.|6 months after discharge|This analysis includes participants for whom the 6-month follow-up data were available.|||Participants|||Count of Participants
2542901|NCT02989805|Secondary|Percentage of Outpatient Visits Attended|Outpatient engagement will be assessed by the percentage of outpatient visits attended.|6 months after discharge|This analysis includes participants who had at least one visit scheduled.|||percentage of visits attended||Standard Deviation|Mean
2542902|NCT02989805|Primary|Number of Participants Attending at Least One Outpatient Visit|This outcome was operationally measured as at least one outpatient visit for a mental health problem in the 30 days after discharge from the emergency department. Data were obtained from the South Carolina Office of Revenue and Fiscal Affairs (RFA). The RFA data warehouse pulls client-specific data from an array of health and human services facilities, agencies and organizations and makes possible the integration of data from disparate sources at the client level by means of an internally assigned unique tracking number.|30 days after discharge|Participants completing the study are included in this analysis.|||Participants|||Count of Participants
2554597|NCT02756689|Secondary|Number of Participants With Spontaneous Rupture of Membranes Between Foley Bulb Placement and Admission||From placement of Foley bulb to 24 hours.||||Participants|||Count of Participants
2542920|NCT02989727|Primary|Montgomery-Asberg Depression Rating Scale (MADRS) Change Scores|"Scale scores range from 0 to 60. This outcome is a change score calculated by subtracting Baseline from Week 8 scores.~Lower scores indicate greater improvement of depressive symptoms."|Eight weeks||||score on a scale||Standard Deviation|Mean
2542921|NCT02989714|Secondary|Time to Progression|Progressive disease is defined as At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.|24 Months|||||||
2542922|NCT02989714|Secondary|The Number of Patients Alive at 24 Months|The Number of Patients Alive at 24 Months|24 Months|||||||
2542923|NCT02989714|Secondary|The Number of Patients With Grade 3-5 Adverse Events of Interest|The Number of Patients with Grade 3-5 Adverse Events of Interest|60 days post treatment|||||||
2542924|NCT02989714|Primary|The Number of Patients That Respond to Treatment|This is the primary outcome for the Phase II portion of the trial. Includes complete response (CR) + partial response (PR), measured by computerized tomography (CT) or magnetic resonance imaging (MRI) scan and assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.|12 Weeks|Patients who received at least 1 dose of Nivolumab and Interleukin-2|||Participants|||Count of Participants
2542925|NCT02989714|Primary|The Number of Patients With Grade 3 and Grade 4 Adverse Events of Interest|This is the primary outcome for the Phase Ib portion of the trial. Events of interest are possibly immune-mediated and occur only after at least one dose of Nivolumab has been administered. Immune-mediated events of interest do not include those that are known to occur during high dose IL-2 monotherapy and are reversible. Grade assessed per CTCAE version 4.0.|28 Days after start of treatment|Patients who received at least 1 dose of Nivolumab and Interleukin-2|||Participants|||Count of Participants
2542926|NCT02989649|Secondary|Time to Alogliptin or Alogliptin FDCs Dose Escalation or Dose Reduction||Months 3 and 6|No participant was experienced the dose adjustment (dose escalation or dose reduction).||||||
2542927|NCT02989649|Secondary|Percentage of Participants Who Remain on Treatment With Alogliptin or Alogliptin FDCs||Months 3 and 6|All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Number analyzed is the number of participants with evaluable data at the given time-point.|||percentage of participants|||Number
2542928|NCT02989649|Secondary|Number of Participants With Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)|An ADR is defined as any response to a medicinal product that is noxious and unintended and that occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of diseases or for the restoration, correction, or modification of physiological function. An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. Adverse events such as pancreatitis, hepatic disorders, and hypersensitivity reactions (including angioedema, anaphylaxis, and Stevens-Johnson syndrome) were considered as AESI.|Baseline up to Month 6|All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once.|||Participants|||Count of Participants
2542929|NCT02989649|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level Over Time|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement.|Baseline and Months 3 and 6|All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Number analyzed is the number of participants with evaluable data at the given time-point.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2542930|NCT02989649|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) Level Over Time|The change between the fasting plasma glucose value collected at Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement.|Baseline and Months 3 and 6|All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Number analyzed is the number of participants with evaluable data at the given time-point.|||mg/dL||Standard Deviation|Mean
2542931|NCT02989649|Secondary|Percentage of Participants With a Decrease in HbA1c Level by >0.3% and No Tolerability Findings|Percentage of participants with a decrease of >0.3% from baseline in HbA1c along with no tolerability findings were reported. Tolerability findings included hypoglycemic event, or weight gain ≥5%.|Baseline and Month 6|All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.|||percentage of participants|||Number
2542932|NCT02989649|Secondary|Percentage of Participants With a Decrease in HbA1c Level by <7.0%|Percentage of participants with a decrease of <7.0% from baseline in HbA1c were reported.|Baseline and Month 6|All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.|||percentage of participants|||Number
2542933|NCT02989649|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. Subgroups included participants with different baseline clinical characteristics with predictors such as prior therapy of diabetes mellitus, sex, age group, cardiovascular risk group, therapy type (monotherapy or combined therapy), baseline body mass index (BMI) and initial glycemic control. A negative change from Baseline indicates improvement.|Baseline and Month 6|All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2554598|NCT02756689|Secondary|Number of Participants Admitted Prior to the Scheduled Induction of Labor Time||From placement of Foley bulb to 24 hours.||||Participants|||Count of Participants
2542934|NCT02989649|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.|Baseline and Month 6|All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2542935|NCT02989545|Secondary|Willingness of the Patient to Continue Using the Anal Tape After the Study.|Willingness of the patient to continue using the device was assessed using a standard 100 mm visual analog scale. Patients were asked to grade their willingness to use the device in the future between 0 and 100 by drawing a perpendicular line in the 100 mm visual analog scale. Then the distance in mm was measured in mm from 0 to the perpendicular line and the score was calculated. Higher scores meaning better satisfaction.|4 weeks|Note that in 3 patients these data were missing, therefore the analysis if for 17 out of 20 participants.|||mm in VAS scale||Inter-Quartile Range|Median
2542936|NCT02989545|Secondary|General Satisfaction|General satisfaction with the device was assessed using a standard 100 mm visual analog scale. Patients were asked to grade their satisfaction with the device between 0 and 100 by drawing a perpendicular line in the 100 mm visual analog scale. Then the distance in mm was measured in mm from 0 to the perpendicular line and the score was calculated. Higher scores meaning better satisfaction.|2 weeks|Note that in 3 patients these data were missing, therefore the analysis if for 17 out of 20 participants.|||mm in VAS scale||Inter-Quartile Range|Median
2542937|NCT02989545|Secondary|Mean Redction in Wexner Scale Compared to Baseline|The Wexner Scale is a measure of frequency and severity of anal incontinence. It comprises five items, three regarding frequency of involuntary passage of gas, liquid, or solid stool, frequency of pad wearing, and frequency of lifestyle alteration, scored in a 5-point Likert-scale (never=0, rarely=1, sometimes=2, usually=3, always=4). A sum of all scores from 0 to 20 is calculated with higher scores meaning more severe incontince.|2 weeks||||score on a scale||Standard Deviation|Mean
2542938|NCT02989545|Secondary|Mean Wexner Score|The Wexner Scale is a measure of frequency and severity of anal incontinence. It comprises five items, three regarding frequency of involuntary passage of gas, liquid, or solid stool, frequency of pad wearing, and frequency of lifestyle alteration, scored in a 5-point Likert-scale (never=0, rarely=1, sometimes=2, usually=3, always=4). A sum of all scores from 0 to 20 is calculated with higher scores meaning more severe incontince.|2 weeks||||score on a scale||Standard Deviation|Mean
2542939|NCT02989545|Secondary|A 50% Reduction in the Number of Episodes of FI Per Week|Number of pateints with reduction of more than 50% in the absolute number of FI events during each week of the study|4 weeks|Note that this outcome was obtained by free text stool diaries that patients had to keep at home. Only 15 patient out of 20 provided full diaries, therefore the analysis is limited to 15 instead of all 20.|||Participants|||Count of Participants
2542940|NCT02989545|Primary|Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs)|"The FIQoL is a validated, condition-specific tool that evaluates quality of life (QoL) in patients with fecal incontinence (FI) it consisting of 29 questions, subdivided into four domains: Lifestyle, Coping/Behavior, Depression/Self‐perception, and Embarrassment. Item 1, general health, is graded from 1 excellent to 5 poor and is reversely scored. Items 2 to 28 are graded on a 4‐point Likert‐scale (1 = lower QoL). Item 29, FI specific depression, is graded from 1 extremely so to 6 not at all. The average score for each domain is calculated separately and is calculated only if half or more of the items in the particular domain have been answered. Scales range from 1 to 5, with a 1 indicating a lower quality of life. Each domain or subscale is reported separately (Range 1 to 5), a total score including all four domains is not calculated."|2 weeks||||score on a scale||Standard Deviation|Mean
2542941|NCT02989389|Secondary|Part B Pharmacodynamics (PD): Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)₁₋₄₀ and Aβ₁₋₄₂|Amyloid beta is a peptide fragment of the amyloid precursor protein, CSF concentrations of Aβ1-40, Aβ1-42 were determined using validated immunoassay methods.|Baseline through 36 hours|All randomized participants from Part B group, who received at least 1 dose of study drug and have baseline and at least one post-baseline CSF Aβ1-40 or Aβ1-42 data.|||Picogram per milliliter (pg/mL)||Standard Deviation|Mean
2542942|NCT02989389|Secondary|Pharmacodynamics (PD): Change From Baseline in Plasma Amyloid Beta (Aβ)₁₋₄₀ and Aβ₁₋₄₂|Amyloid beta is a peptide fragment of the amyloid precursor protein, plasma concentrations of Aβ1-40 and Aβ1-42 were determined using validated immunoassay methods.|Baseline through 144 hours|All randomized participants who received at least 1 dose of study drug and have baseline and at least one post-baseline plasma Aβ1-40 or Aβ1-42 data.|||Picogram per milliliter (pg/mL)||Standard Deviation|Mean
2542943|NCT02989389|Secondary|Part B Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Cerebrospinal Fluid (CSF)|Part B Pharmacokinetics (PK): Area under the concentration time curve from time zero to tlast (AUC[0-tlast]) of LY3323795 in cerebrospinal fluid (CSF).|-4, -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36 hours, post dose|All randomized participants from Part B group, who received at least 1 dose of study drug and had evaluable PK data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2542944|NCT02989389|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3323795 in Plasma|Pharmacokinetics (PK): Area under the concentration time curve from time zero to tlast (AUC[0-tlast]) of LY3323795 in plasma.|0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72,96,120,144 hours, post dose|All randomized participants who received at least 1 dose of study drug and had evaluable PK data.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2542945|NCT02989389|Secondary|Part B Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Cerebrospinal Fluid (CSF)|Part B Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3323795 in cerebrospinal fluid (CSF).|-4, -2, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36 hours, post dose|All randomized participants from Part B group, who received at least 1 dose of study drug and had evaluable PK data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2542946|NCT02989389|Secondary|Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3323795 in Plasma|Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3323795 in plasma.|0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72,96,120,144 hours, post dose|All randomized participants who received at least 1 dose of study drug and had evaluable PK data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2542947|NCT02989389|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 19.1. A summary of non-serious adverse events and all serious adverse events, regardless of causality is located in the Reported Adverse Events section.|Baseline to Study Completion (up to Day 43)|All randomized participants who received study drug.|||Participants|||Count of Participants
2542948|NCT02988882|Primary|Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6|Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching|7 minutes||||units on a scale||Standard Deviation|Mean
2542949|NCT02988882|Primary|Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6|Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching|5 minutes||||units on a scale||Standard Deviation|Mean
2542950|NCT02988882|Primary|Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6|Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching|3 minutes||||units on a scale||Standard Deviation|Mean
2542951|NCT02988622|Primary|Observer Total Score|Change in total observer score made up of components rating the scar appearance based on photos at baseline and photos at 6 months. Scale includes the following components: Visual analog scale from 0 to 10 (with 0 being excellent appearance and 10 being worst appearance), scar color, contour and distortion (these 3 measures were graded from 1 to 4 with 1 equating to perfect and 4 equating to worst appearance), scar finish (matte scar was given a score of 1 and shiny scar was given a score of 2). The total score of the above components provided an overall observer score, with 4 being the best score possible (equating to best appearing scar) and 24 being the worst score possible (equating to worst appearing scar).|Baseline and 6 months.|Patients with available data.|||units on a scale||Standard Deviation|Mean
2542952|NCT02988622|Primary|Patient Satisfaction|Patients rated how satisfied they were with the appearance of each half of the treated scar.|6 months|Participants with available data.|||Participants|||Count of Participants
2542953|NCT02988622|Primary|Overall Opinion|Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.|Baseline and 6 months|Patients with available data at the 6-month time point.|||units on a scale||Standard Deviation|Mean
2542954|NCT02988622|Primary|Scar Irregularity|Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.|Baseline and 6 months|Patients with available data at the 6-month time point.|||units on a scale||Standard Deviation|Mean
2542955|NCT02988622|Primary|Scar Thickness|Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.|Baseline and 6 months|Patients with available data at the 6-month time point.|||units on a scale||Standard Deviation|Mean
2542956|NCT02988622|Primary|Scar Stiffness|Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.|Baseline and 6 months|Patients with available data at the 6-month time point.|||units on a scale||Standard Deviation|Mean
2542957|NCT02988622|Primary|Scar Color|Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.|Baseline and 6 months|Patients with available data at the 6-month time point.|||units on a scale||Standard Deviation|Mean
2542958|NCT02988622|Primary|Scar Itching|Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.|Baseline and 6 months|Patients with available data at the 6-month time point.|||units on a scale||Standard Deviation|Mean
2542959|NCT02988622|Primary|Scar Pain|Patient and Observer Scar Assessment Scale (POSAS). Minimum of 1 and maximum of 10 (higher score is equivalent to a worse outcome). These are patient recorded scores.|Baseline and 6 months|Patients with available data at the 6-month time point.|||units on a scale||Standard Deviation|Mean
2542960|NCT02988349|Secondary|The Change of Relative Activities of Microbial Enzymes After Intervention as Determined by Laboratory Enzymatic Assays|Saliva and dental plaque samples will be collected and microbial enzyme activity will be quantified in the lab. Measures include relative enzyme activity of arginine deiminase, urease and lactase dehydrogenase as determined by standard laboratory enzymatic assay protocols.|baseline ,2 week|Among the 21 participants in each group，we only measured the enzyme activity from randomly choosed 15 participants from each group.|||enzyme activity (μmol/min/g)||Standard Deviation|Mean
2542961|NCT02988349|Primary|The Change of Abundance of Specific Oral Microbes After Intervention as Assessed by 16S rRNA Sequencing|Saliva and dental plaque samples will be collected, and the abundance of specific oral microbes such as Streptococcus mutans, Streptococcus sanguinis will be quantified by microbial 16S rRNA sequencing.|baseline , 2 week||||percentage of bacteria||Standard Deviation|Mean
2542962|NCT02988219|Secondary|The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed|The investigator evaluates the incidence of cardiac arrhythmias depending on anesthesia method by observing the number and type of arrhythmias and whether additional interventions were needed to treat them|60 months|arrhythmias analysed: bradycardia, pause > 2s, supraventricular extrasystoles, ventricular extrasystoles; corrected QT interval (QTc)|||Participants|||Count of Participants
2542972|NCT02987972|Primary|Percentage of Participants With a Solicited Systemic Adverse Event|Systemic AEs solicited on the Vaccine Report Card were fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with 1 or more solicited systemic AEs was assessed.|Up to 14 days post any vaccination|All participants that received at least 1 vaccination and had data available for endpoint.|||Percentage of Participants|||Number
2542963|NCT02988219|Primary|Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period|"The investigator evaluates the incidence of cardiac arrhythmias, the type of arrhythmias and whether additional interventions were needed to treat them~Arrhythmias observed:~tachycardia >100 bpm bradycardia < 50 bpm pause (P-P interval > 2 seconds) ventricular extrasystoles (VE) > 1000/ 24 hours supraventricular extrasystoles (SVE) >200/24 hours"|60 months||||Participants|||Count of Participants
2542964|NCT02988193|Primary|Clinical Adoption of a Decision Support Artificial Intelligence|"Total number of participants that undergone a treatment change.~This measure allows to evaluate the adoption of the optima4BP treatment recommendation based on the total number of patients that benefited from a treatment recommendation that was implemented by the treating physician."|6 months|Clinical adoption based on physician acceptance of the treatment recommendation|||Participants|||Count of Participants
2542965|NCT02988115|Secondary|Absolute Change From Baseline in LDL-C at Week 12 and Week 24|Change from Baseline is calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value ) x 100. Baseline is defined as the mean of the last two non-missing values on or prior to Day 1.|Baseline; Week 12; Week 24|FAS. Only those participants with available data were analyzed.|||mg/dL||Standard Deviation|Mean
2542966|NCT02988115|Secondary|Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 12|Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline for hsCRP is defined as the last non-missing value on or prior to Day 1. Percent change from Baseline in hsCRP, non-parametric (Wilcoxon rank-sum test) analysis with Hodges-Lehmann estimates and confidence interval was performed.|Baseline; Week 12|FAS. Only those participants with available data were analyzed.|||percent change||Inter-Quartile Range|Median
2542967|NCT02988115|Secondary|Percent Change From Baseline in the Lipid Profile at Week 12|PCFB was calculated as: ([post-BL value minus the BL value] divided by the BL value) x 100. BL was defined as the mean of the last two non-missing values on or prior to Day 1. If only one value was available, that single value was used as BL. apoB and TC BL were defined as the last non-missing value on/prior to Day 1. PCFB was analyzed using ANCOVA, with treatment and group stratification factor (primary prevention; secondary prevention) as fixed effects and BL as a covariate. For participants with missing data at Week 12 who were no longer taking study treatment (ST), missing values were imputed using multiple imputation via a regression-based model including stratification and BL data from placebo participants only. In this imputation model, treatment group was not included. For participants with missing lipid data at Week 12 who were still taking ST, missing values were imputed using multiple imputation via a regression-based model including treatment, stratification and BL value.|Baseline; Week 12|FAS. Only those participants with available data were analyzed.|||percent change||Standard Error|Least Squares Mean
2542968|NCT02988115|Secondary|Percent Change From Baseline in LDL-C at Week 24|PCFB was calculated as the ([post-BL value minus the BL value] divided by the BL value ) x 100. BL was defined as the mean of the last two non-missing values on or prior to Day 1. If only one value was available then that single value was used as BL. PCFB in LDL-C was analyzed using ANCOVA, with treatment group and stratification factor (primary prevention; secondary prevention) as fixed effects and BL as a covariate. For participants with missing lipid data at Week 12 who were no longer taking study treatment, missing values were imputed using multiple imputation via a regression-based model including stratification and BL data from placebo participants only. In this imputation model, treatment group was not included. For participants with missing lipid data at Week 12 who were still taking study treatment, missing values were imputed using multiple imputation via a regression-based model including treatment, stratification and BL value.|Baseline; Week 24|FAS. Only those participants with available data were analyzed.|||percent change||Standard Error|Least Squares Mean
2542969|NCT02988115|Primary|Percent Change From Baseline (PCFB) in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12|PCFB was calculated as the ([post-Baseline (BL) value minus the BL value] divided by the BL value ) x 100. BL was defined as the mean of the last two non-missing values on or prior to Day 1. If only one value was available, that single value was used as BL. PCFB in LDL-C was analyzed using analysis of covariance (ANCOVA), with treatment group and stratification factor (primary prevention; secondary prevention) as fixed effects and BL as a covariate. For participants with missing lipid data at Week 12 who were no longer taking study treatment, missing values were imputed using multiple imputation via a regression-based model including stratification and BL data from placebo participants only. In this imputation model, treatment group was not included. For participants with missing lipid data at Week 12 who were still taking study treatment, missing values were imputed using multiple imputation via a regression-based model including treatment, stratification and BL value.|Baseline; Week 12|The Full Analysis Set (FAS), also known as the intention-to-treat (ITT) set of participants, is defined as all randomized participants. Participants were included in their randomized treatment group, regardless of the treatment they actually received. Only those participants with available data were analyzed.|||percent change||Standard Error|Least Squares Mean
2542970|NCT02987972|Secondary|Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4|Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.|1 month post vaccination 4 (Month 11-14)|Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed.|||µg/mL||95% Confidence Interval|Mean
2542971|NCT02987972|Secondary|Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4|Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.|Before Vaccination 4 (Month 10 to 13)|Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed.|||µg/mL||95% Confidence Interval|Mean
2542999|NCT02986958|Secondary|Companion Verbal Activity|Companion verbal activity is the proportion of visit statements contributed by the companion in relation to overall visit statements, including statements by the patient and primary care provider.|During enrollment visit, up to 77 minutes||||Proportion of visit statements||Standard Error|Mean
2542973|NCT02987972|Primary|Percentage of Participants With a Solicited Injection-site Adverse Event|Injection-site AEs solicited on the Vaccine Report Card were redness, swelling, hard lump, and pain/tenderness. The percentage of participants with 1 or more solicited injection-site AEs was assessed.|Up to 14 days post any vaccination|All participants that received at least 1 vaccination and had data available for endpoint.|||Percentage of Participants|||Number
2542974|NCT02987972|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event|The percentage of participants who discontinued the study because of an AE (as defined above) was assessed.|Up to 1 month post Vaccination 4 (up to 14 months)|All participants that received at least 1 vaccination and had data available for endpoint.|||Percentage of Participants|||Number
2542975|NCT02987972|Primary|Percentage of Participants Who Experience at Least 1 Adverse Event|An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more AEs was assessed.|Up to 1 month post Vaccination 4 (up to 14 months)|All participants that received at least 1 vaccination and had data available for endpoint.|||Percentage of Participants|||Number
2542976|NCT02987972|Primary|Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3|Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery (MSD) Pn electrochemiluminescence assay. The geometric mean concentration (GMC) of serotype-specific IgG will be assessed.|1 month post Vaccination 3 (Month 5)|Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed.|||µg/mL||95% Confidence Interval|Geometric Mean
2542977|NCT02987972|Primary|Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3|Serotype-specific pneumococcal IgG antibody was measured using the Meso-Scale Discovery (MSD) Pneumococcal electrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.|1 month post vaccination 3 (Month 5)|Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed.|||Percentage of Participants||95% Confidence Interval|Number
2542978|NCT02987868|Primary|Percent Change of Triiodthyronine Over Baseline|Measure Triiodthyronine at times 0-120 minutes on two occasions about one week apart. On one occasion, the proprietary amino acid derivative blend will be given orally at time 0 in capsule form, and on the other occasion the capsules will contain no amino acids.|0-120 minutes, at Baseline and post dose, week 1 and week 3||||percent change||Standard Deviation|Mean
2542979|NCT02987660|Secondary|Mean Uncorrected Visual Acuity (UCVA) at 3 Months|"Uncorrected (without spectacles or other visual corrective devices) Visual Acuity (UCVA) testing was conducted monocularly in photopic conditions without glare at 3 or 4 meters. Visual Acuity (VA) is measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity. The Precision Vision illuminator cabinets and ETDRS charts were used. For subjects who could not read English letters, a numerical, Tumbling E logMAR chart was used. Since the study was terminated early, inferential statistics could not be completed."|Month 3|ITT with non-missing data|||logMAR|Eyes|Standard Deviation|Mean
2542980|NCT02987660|Secondary|Mean Manifest Refraction Cylinder at 3 Months|Manifest refraction cylinder was measured monocularly at 3 or 4 meters under photopic lighting conditions using a phoropter and ETDRS chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.|Month 3|ITT with non-missing data|||Diopters|Eyes|Standard Deviation|Mean
2542981|NCT02987660|Primary|Percentage of Eyes With Manifest Refraction Cylinder Less Than or Equal to 0.5 Diopter (D) at 3 Months|Manifest refraction cylinder was measured monocularly (each eye separately) at 3 or 4 meters (m) under photopic lighting conditions using a phoropter and Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The manifest refraction at 4 m or 3 m was adjusted for optical infinity by adding -0.25 D to the sphere value. Both eyes contributed to the analysis. Since the study was terminated early, inferential statistics could not be completed.|Month 3|ITT with non-missing data|||percentage of eyes|Eyes|95% Confidence Interval|Number
2542982|NCT02987621|Primary|6 Minute Walk Test|After completion of the tDCS/Sham strength assessment participants will perform a 6 minute walk test. The test will be performed in a cordoned off hallway with 2 cones placed 30 meters apart. Once the participants begin walking, a timer will be started and the distance covered every min will be recorded. Participants are allowed to stop and rest during the test if required. Every minute during the walk test participants will be asked their rating of perceived exertion (RPE, 0-10 scale).|At session 1 and minimum of 7 days later|No data was collected||||||
2542983|NCT02987621|Primary|Leg Muscle Endurance With and Without tDCS.|"Knee extensor endurance (fatigue) will be tested with tDCS (less than 10V) and sham stimulation (0V), as reported as time to failure.~During tDCS, stimulation intensity was ramped up to 2 mA, started 90 second sprior to the task, and extended until task failure or a maximum stimulation length of 20 minutes. For Sham, the current was ramped up to 2 mA, but turned off after 30 seconds."|At session 1 and minimum of 7 days later.|Crossover design|||seconds||Standard Error|Mean
2543000|NCT02986958|Secondary|Patient Verbal Activity|Patient verbal activity is the proportion of visit statements contributed by the patient in relation to overall visit statements, including statements by the companion and primary care provider.|During enrollment visit, up to 77 minutes||||Proportion of visit statements||Standard Error|Mean
2543001|NCT02986958|Secondary|Visit Duration|Duration of primary care visit in minutes|During enrollment visit, up to 77 minutes||||minutes||Standard Error|Mean
2554599|NCT02756689|Secondary|Number of Participants Calling the Obstetrical Triage Unit||From placement of Foley bulb to 24 hours.||||Participants|||Count of Participants
2542984|NCT02987621|Primary|Leg Muscle Strength With and Without tDCS.|"Knee extensor strength will be tested with tDCS (less than 10V) and sham stimulation (0V). Participants performed maximal voluntary contractions (MVCs) with the knee extensors to objectively determine the weaker leg as more-affected, which was afterwards confirmed by the subject's self-report and used for the subsequent endurance task. This task consisted of a sustained isometric contraction at 15% MVC until volitional task termination and was immediately followed by a post MVC.~During tDCS, stimulation intensity was ramped up to 2 mA, started 90 second sprior to the task, and extended until task failure or a maximum stimulation length of 20 minutes. For Sham, the current was ramped up to 2 mA, but turned off after 30 seconds."|At session 1 and minimum of 7 days later|Crossover design|||Newtons||Standard Error|Mean
2542985|NCT02987374|Other Pre-specified|Proteomic Analysis of Antibody CDR3 Regions at 10 Different Time Points Before and After Immunization.|Proteomic analysis: Identification, production, and characterization of Influenza A specific antibodies and their CDRH3 amino-acid sequences.|Day -5 to 180 post-immunization|||||||
2542986|NCT02987374|Secondary|Number of Participants With Related Adverse Events||Day 0 to 180 post-immunization|Number of participants with related adverse events up to 180 days post immunization|||Participants|||Count of Participants
2542987|NCT02987374|Primary|Number of Participants Who Received Influenza Vaccine||Day 0 to 180 post-immunization|10 participants received the 2011-2012 Fluzone IIV3 vaccine|||Participants|||Count of Participants
2542988|NCT02987231|Secondary|Root Coverage Esthetic Score|The Root Coverage Esthetic Scale (RES; Cairo et al. 2009) was performed by two blinded and independent examiners (CFA and IFM) at the 6-month post-operative assessment. This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color. Because complete root coverage was the primary treatment goal, and the other variables were considered secondary, the value assigned for root coverage was 60% of the total score, whereas 40% was assigned to the other four variables. With regard to the assessment of the final position of the gingival margin, 3 points were given for partial root coverage, and 6 points were given for complete root coverage; 0 points were assigned when the final position of the gingival margin was equal or apical to the previous recession. One point was assigned for each of the other four variables. The final score ranged from 0-10, higher values were considered better.|6 months||||units on a scale||Standard Deviation|Mean
2542989|NCT02987231|Primary|Percentage of Defect Coverage|Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.|6 months||||percentage of root coverage||Standard Deviation|Mean
2542990|NCT02987205|Other Pre-specified|Other Efficacy Variables Include Change in Investigator Global Aesthetic Improvement (iGAI) Score|Treatment success is (defined as at least a 1-grade improvement in WSRS from baseline to Week 24)|Visit 2/Week 1, Visit 3/Week 2, Visit 4/Week 4, and Visit 5/Week 12|||||||
2542991|NCT02987205|Other Pre-specified|Other Efficacy Variables Include Change in Patient Global Aesthetic Improvement (pGAI) Score|Treatment success is (defined as at least a 1-grade improvement in WSRS from baseline to Week 24)|Visit 2/Week 1, Visit 3/Week 2, Visit 4/Week 4, and Visit 5/Week 12|||||||
2542992|NCT02987205|Other Pre-specified|Other Efficacy Variables Include Change in WSRS Score|Treatment success is (defined as at least a 1-grade improvement in WSRS from baseline to Week 24)|Visit 2/Week 1, Visit 3/Week 2, Visit 4/Week 4, and Visit 5/Week 12|||||||
2542993|NCT02987205|Secondary|Secondary Efficacy Endpoints Are the Responder Rate, Percentage of *Nasolabial Folds* With Treatment Success|"Treatment success (defined as at least a 1-grade improvement in WSRS from baseline to Week 24):~The WSRS Score is a 5-point scale. The WSRS score was assessed for each NLF at every study visit through Visit 6/Week 24 by a blinded evaluator (blinded to the treatment assignment of each NLF)."|Visit 6/Week 24|Per-Protocol (PP) Population|||Nasolabial Folds|Nasolabial Folds||Count of Units
2542994|NCT02987205|Primary|Primary Efficacy Variable is Change From Baseline to Visit 6/Week 24 in Wrinkle Severity Rating Scale (WSRS) Score|"Primary efficacy variable is change from Baseline to Visit 6/Week 24 in Wrinkle Severity Rating Scale (WSRS) - Treatment success is defined as at least a 1-grade improvement in WSRS from baseline to Week 24~WSRS Score categories:~Absent - No visible fold; continuous skin line.~Mild - Shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance.~Moderate - Moderately deep folds; clear facial feature visible at normal appearance but not when stretched; excellent correction is expected from injectable implant.~Severe - Very long and deep folds; prominent facial feature; less than 2 mm visible when stretched; significant improvement is expected from injectable implant.~Extreme - Extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone."|Visit 6/Week 24|Analysis of effectiveness based on Per Protocol analysis which includes 125 evaluable patients at 24 weeks.|||scores on a scale|Nasolabial Folds|95% Confidence Interval|Mean
2542995|NCT02986958|Secondary|Number of Primary Care Providers Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit|"The number of primary care providers who endorsed Agree or Strongly Agree to the statement: Overall, I was satisfied with today's visit."|During Enrollment visit, up to 77 minutes||||Participants|||Count of Participants
2542996|NCT02986958|Secondary|Number of Companions Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit|"The number of companions who endorsed Agree or Strongly Agree to the statement: Overall, I was satisfied with today's visit."|During Enrollment visit, up to 77 minutes||||Participants|||Count of Participants
2542997|NCT02986958|Secondary|Number of Patients Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit|"The number of patients who endorsed Agree or Strongly Agree to the statement: Overall, I was satisfied with today's visit."|During Enrollment visit, up to 77 minutes|The number of patient participants for this patient-reported outcome measure sums to 86 because 7 of the 93 total patient participants were too cognitively impaired to respond to the paper-pencil post-visit survey.|||Participants|||Count of Participants
2542998|NCT02986958|Secondary|Number of Participants for Whom There Was Any Discussion of the Patient's Memory and/or Cognition During the Primary Care Visit|The number of participants for whom there was any discussion of the patient's memory and/or cognition during the audio-recorded primary care visit.|During enrollment visit, up to 77 minutes||||Participants|||Count of Participants
2554600|NCT02756689|Secondary|Number of Participants Using Acetaminophen||From placement of Foley bulb to 24 hours.||||Participants|||Count of Participants
2543002|NCT02986958|Primary|Ratio of Psychosocial and Socio-emotional Statements Relative to Biomedical Talk and Orientation Statements (Patient-Centered Communication)|Patient-centered communication is reflected as a ratio of psychosocial and socio-emotional statements relative to biomedical talk and orientation statements from coded audio-taped communication during primary care visits. Higher values indicate more patient-centered communication.|During enrollment visit, up to 77 minutes||||Ratio||Standard Error|Mean
2543003|NCT02986854|Secondary|Within Group hSBA Geometric Mean Ratios (GMRs)|Within each study group and for each serogroup, GMRs were calculated,at: Visit Day 4 versus at Visit Day 1; Visit Day 6 versus at Visit Day 1; and Visit Day 29 versus at Visit Day 1. The unadjusted GMRs and 95% CIs are constructed by exponentiating the mean within-group differences in log-transformed titers and the corresponding 95% CIs.|At Day 4, Day 6, Day 29 compared to Day 1|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Ratios||95% Confidence Interval|Geometric Mean
2543004|NCT02986854|Secondary|hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y.|For each N. meningitidis serogroup A, C, W and Y, unadjusted GMTs were calculated, with their associated two-sided 95% Confidence Interval.|At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Titers||95% Confidence Interval|Geometric Mean
2543005|NCT02986854|Secondary|Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y|Seroresponse is defined for this study as follows: For subjects with pre-vaccination titers <4, postvaccination titers ≥ 16; for subjects with pre-vaccination titers ≥4, post vaccination titers at least 4 times the pre-vaccination titers.|At Day 4 and Day 6|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Percentages of subjects||95% Confidence Interval|Number
2543006|NCT02986854|Secondary|Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y|For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.|At day 1(pre-vaccination) , day 4, day 6 and day 29|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Percentage of subjects||95% Confidence Interval|Number
2543007|NCT02986854|Secondary|Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W|For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.|At day 1(pre-vaccination), day 4, day 6 and day 29|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Percentage of subjects||95% Confidence Interval|Number
2543008|NCT02986854|Secondary|Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|At day 1(pre-vaccination) , day 4, day 6 and day 29|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Percentage of subjects||95% Confidence Interval|Number
2543009|NCT02986854|Secondary|Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A|For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.|At day 1(pre-vaccination), day 4, day 6 and day 29|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Percentage of subjects||95% Confidence Interval|Number
2543010|NCT02986854|Secondary|Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y|For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.|At day 1(pre-vaccination), day 4, day 6 and day 29|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Percentage of subjects||95% Confidence Interval|Number
2543011|NCT02986854|Secondary|Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W|For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.|At day 1(pre-vaccination), day 4, day 6 and day 29|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Percentage of subjects||95% Confidence Interval|Number
2543020|NCT02986711|Secondary|Proportion of Participants Providing Smoking Cessation Status Via Text Message|proportion of participants providing data about smoking status via text message at 28 days|28 days||||Participants|||Count of Participants
2543012|NCT02986854|Secondary|Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C|For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.|At day 1(pre-vaccination) , day 4, day 6 and day 29|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Percentage of subjects||95% Confidence Interval|Number
2543013|NCT02986854|Secondary|Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A|For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.|At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29|Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup|||Percentages of subjects||95% Confidence Interval|Number
2543014|NCT02986854|Secondary|Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs)|"Medically attended AEs were defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.~SAE was defined as any untoward medical occurrence that at any dose resulted in: death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, an important and significant medical event that might not have been immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, might jeopardized the subject or might required intervention to prevent one of the other outcomes listed."|From Day 1 through Day 181 (entire study period)|Analysis was performed on the unsolicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject’s randomization and treatment status in the study, received a subject ID and reported any unsolicited adverse event.|||Participants|||Count of Participants
2543015|NCT02986854|Secondary|Number of Subjects Reporting All Unsolicited AEs|An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event was an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.|From Day 1 through Day 29 after vaccination|Analysis was performed on the unsolicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject’s randomization and treatment status in the study, received a subject ID and reported any unsolicited adverse event.|||Participants|||Count of Participants
2543016|NCT02986854|Secondary|Number of Subjects Reporting Other Indicators of Reactogenicity|Assessed indicators of reactogenicity were use of analgesics/antipyretics for prophylaxis, use of analgesics/antipyretics for treatment, body temperature (described as 0.5 °C increments from ≥ 36.0ºC)|From Day 1 (6 hours) through Day 7 after vaccination|Analysis was performed on the solicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject’s randomization and treatment status in the study, received a subject ID and reported any solicited adverse event.|||Participants|||Count of Participants
2543017|NCT02986854|Secondary|Number of Subjects Reporting Solicited Local and Systemic AEs|Assessed solicited local symptoms were injection site pain, erythema, induration. Assessed solicited systemic symptoms were fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills and fever [defined and measured by a body temperature ≥37.5 degrees Celsius (ºC)]. Threshold for Erythema and Induration: Grade 0 (<25 mm), Any (>= 25 mm)|From Day 1 (6 hours) through Day 7 after vaccination|Analysis was performed on the solicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject’s randomization and treatment status in the study, received a subject ID and reported any solicited adverse event.|||Participants|||Count of Participants
2543018|NCT02986854|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event is an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.|Within 30 minutes after vaccination|Analysis was performed on the unsolicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject’s randomization and treatment status in the study, received a subject ID and reported any unsolicited adverse event.|||Participants|||Count of Participants
2543019|NCT02986854|Primary|Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y.|Seroresponse was defined as follows:for subjects with pre-vaccination hSBA titers< 4,postvaccination hSBA titers≥16;for subjects with pre-vaccination hSBA titers≥4,post vaccination hSBA titers of atleast 4 times the pre-vaccination titers.Criteria to demonstrate primary objectives:Immune response sufficiency was tested sequentially;first in the group of subjects who received primary vaccination with Menveo &,if met,also in group of subjects who received primary vaccination with Menactra.Immune response is considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, W & Y is greater than 75%.Study is considered successful if immune response sufficiency is demonstrated atleast in group of subjects who received primary vaccination with Menveo.This outcome measure was assessed only on subjects from Menveo-Menveo & Menactra-Menveo groups.Data from pooled and Naive groups are presented as part of secondary objectives|At Day 29|Analysis was performed on the per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis who received the study vaccination & provided evaluable serum samples at Day 29 with results available for atleast one serogroup|||Percentage of subjects||95% Confidence Interval|Number
2543021|NCT02986711|Primary|Complete Self-reported Tobacco Abstinence During the Prior 7 Days, as Reported on Telephone Interview, 28 Days After Discharge From Hospital (With Biochemical Verification in a Sub-sample, Exhaled Carbon-monoxide < 10 Parts Per Million).|Abstinence rate at 28 days|28 days||||Participants|||Count of Participants
2543022|NCT02986373|Secondary|SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 52|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 52|Safety analysis set.|||units on a scale||95% Confidence Interval|Median
2543023|NCT02986373|Secondary|SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 48|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 48|Safety analysis set.|||units on a scale||95% Confidence Interval|Median
2543024|NCT02986373|Secondary|SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 36|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 36|Safety analysis set.|||units on a scale||95% Confidence Interval|Median
2543025|NCT02986373|Secondary|SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 24|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 24|Safety analysis set.|||units on a scale||95% Confidence Interval|Median
2543026|NCT02986373|Secondary|SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 12|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 12|Safety analysis set.|||units on a scale||95% Confidence Interval|Median
2543027|NCT02986373|Secondary|SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 4|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 4|Safety analysis set.|||units on a scale||95% Confidence Interval|Median
2543028|NCT02986373|Secondary|SF-36 Mental Component Summary (MCS) Score: Change From Baseline (in the Lead-in Study) to Week 0|The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 0|Safety analysis set.|||units on a scale||95% Confidence Interval|Median
2543029|NCT02986373|Secondary|SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 52|The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 52|Safety analysis set.|||units on a scale||95% Confidence Interval|Median
2543056|NCT02986139|Secondary|Number of Participants With Adverse Events|The severity of each adverse event was graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|From first dose of etanercept to 30 days after the last dose; 38 days.|The safety analysis set included all participants who received at least 1 dose of etanercept during the study.|||Participants|||Count of Participants
2543030|NCT02986373|Secondary|SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 48|The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 48|Safety analysis set.|||units on a scale||95% Confidence Interval|Median
2543031|NCT02986373|Secondary|SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 36|The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 36|Safety analysis set.|||units on a scale||95% Confidence Interval|Median
2543032|NCT02986373|Secondary|SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 24|The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 24|Safety analysis set.|||units on a scale||95% Confidence Interval|Median
2543033|NCT02986373|Secondary|SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 12|The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 12|Safety analysis set.|||units on a scale||95% Confidence Interval|Median
2543034|NCT02986373|Secondary|SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 4|The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 4|Safety analysis set.|||units on a scale||95% Confidence Interval|Median
2543035|NCT02986373|Secondary|Short Form Health Survey 36 (SF-36) Physical Component Summary (PCS) Score: Change From Baseline (in the Lead-in Study) to Week 0|The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 0|Safety analysis set.|||units on a scale||95% Confidence Interval|Median
2543036|NCT02986373|Secondary|HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 52|The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 52|Safety analysis set.|||units on a scale||95% Confidence Interval|Mean
2543037|NCT02986373|Secondary|HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 48|The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 48|Safety analysis set.|||units on a scale||95% Confidence Interval|Mean
2543057|NCT02986139|Secondary|Injection Site Pain by Disease Indication|Injection site pain was assessed using a 100 mm visual analog scale (VAS), from 0 mm (No Pain At All) to 100 mm (Worst Pain Imaginable). Participants were asked to indicate the severity of their pain at the injection site by placing a vertical line on the scale.|Immediately following injection of each study drug on day 1 and day 8 of this crossover study|Primary analysis set|||mm||Standard Deviation|Mean
2543038|NCT02986373|Secondary|HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 36|The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 36|Safety analysis set.|||units on a scale||95% Confidence Interval|Mean
2543039|NCT02986373|Secondary|HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 24|The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 24|Safety analysis set.|||units on a scale||95% Confidence Interval|Mean
2543040|NCT02986373|Secondary|HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 12|The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 12|Safety analysis set.|||units on a scale||95% Confidence Interval|Mean
2543041|NCT02986373|Secondary|HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 4|The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 4|Safety analysis set.|||units on a scale||95% Confidence Interval|Mean
2543042|NCT02986373|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI): Change From Baseline (in the Lead-in Study) to Week 0|The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 0|Safety analysis set.|||units on a scale||95% Confidence Interval|Mean
2543043|NCT02986373|Secondary|Percentage of Participants Achieving ACR20 Response at Week 52|Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 52: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.|Week 52|Safety analysis set.|||percentage of participants||95% Confidence Interval|Number
2543044|NCT02986373|Secondary|Percentage of Participants Achieving ACR20 Response at Week 48|Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 48: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.|Week 48|Safety analysis set.|||percentage of participants||95% Confidence Interval|Number
2543045|NCT02986373|Secondary|Percentage of Participants Achieving ACR20 Response at Week 36|Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 36: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.|Week 36|Safety analysis set.|||percentage of participants||95% Confidence Interval|Number
2543086|NCT02985684|Secondary|Measured Residual Target Defect Size|Measured residual defect size (in millimeters) as determined by the Echo Core Lab at the 6-month evaluation.|6 months|Pivotal subjects with technical success and 6-month measured residual defect status evaluation|||mm||Full Range|Median
2543046|NCT02986373|Secondary|Percentage of Participants Achieving ACR20 Response at Week 24|Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 24: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.|Week 24|Safety analysis set.|||percentage of participants||95% Confidence Interval|Number
2543047|NCT02986373|Secondary|Percentage of Participants Achieving ACR20 Response at Week 12|Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 12: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.|Week 12|Safety analysis set.|||percentage of participants||95% Confidence Interval|Number
2543048|NCT02986373|Secondary|Percentage of Participants Achieving ACR20 Response at Week 4|Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 4: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.|Week 4|Safety analysis set.|||percentage of participants||95% Confidence Interval|Number
2543049|NCT02986373|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 0|Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 0: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity visual analog scale (VAS), Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study.|Week 0|Safety analysis set.|||percentage of participants||95% Confidence Interval|Number
2543050|NCT02986373|Secondary|mTSS: Change From Baseline (in the Lead-in Study) to Week 48|The mTSS is a measure of change in joint health. X-rays of hands, wrists, and feet (including distal interphalangeal joints) were obtained at Week 24 and Week 48. Totals for hands and feet for erosion scores (range 0 to 320) and joint space narrowing scores (range 0 to 208) were calculated and added to obtain the mTSS (range = 0 [normal] to 528 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening; no progression was defined as a change of ≤0.5. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 48|Safety analysis set.|||units on a scale||95% Confidence Interval|Mean
2543051|NCT02986373|Secondary|mTSS: Change From Baseline (in the Lead-in Study) to Week 24|The mTSS is a measure of change in joint health. X-rays of hands, wrists, and feet (including distal interphalangeal joints) were obtained at Week 24 and Week 48. Totals for hands and feet for erosion scores (range 0 to 320) and joint space narrowing scores (range 0 to 208) were calculated and added to obtain the mTSS (range = 0 [normal] to 528 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening; no progression was defined as a change of ≤0.5. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 24|Safety analysis set.|||units on a scale||95% Confidence Interval|Mean
2543052|NCT02986373|Secondary|Modified Total Sharp Score (mTSS): Change From Baseline (in the Lead-in Study) to Week 24 in the Lead-in Study|The mTSS is a measure of change in joint health. X-rays of hands, wrists, and feet (including distal interphalangeal joints) were obtained at Week 24 and Week 48. Totals for hands and feet for erosion scores (range 0 to 320) and joint space narrowing scores (range 0 to 208) were calculated and added to obtain the mTSS (range = 0 [normal] to 528 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening; no progression was defined as a change of ≤0.5. Baseline is defined as baseline in the lead-in study.|Baseline (Lead-in Study), Week 24 (Lead-in Study)|Safety analysis set.|||units on a scale||95% Confidence Interval|Mean
2543053|NCT02986373|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as an AE that began or worsened in severity after initiation of study drug and 20 weeks (140 days) after last dose. Abbreviations: NMSC=non-melanoma skin cancer|From the first dose of study drug in this study until 20 weeks after the last dose of study drug (up to 56 weeks).|Safety Analysis Set: consists of all participants who have received at least 1 dose of study medication in Study M16-244 (this study).|||participants|||Number
2543054|NCT02986282|Secondary|Difference Between ABI Measured Before and After Electrical Cardioversion Using Doppler Method.|3 ABI measurements using doppler method were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants|Through the study period||||ratio||Inter-Quartile Range|Median
2543055|NCT02986282|Primary|Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric).|3 ABI measurements using both methods (doppler and oscillometric) were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants.|Through the study||||ratio||Inter-Quartile Range|Median
2543058|NCT02986139|Primary|Injection Site Pain|Injection site pain was assessed using a 100 mm visual analog scale (VAS), from 0 mm (No Pain At All) to 100 mm (Worst Pain Imaginable). Participants were asked to indicate the severity of their pain at the injection site by placing a vertical line on the scale.|Immediately following injection of each study drug on day 1 and day 8 of this crossover study|The primary analysis set included all participants who received both doses of commercial and new etanercept during each study period and who completed the injection site pain score during both study periods.|||mm||Standard Deviation|Mean
2543059|NCT02985996|Secondary|PrEP Efficacy as Measured by Inhibition of in Vitro Infection of Rectal Biopsies to HIV|"Rectal biopsies will be subjected to in vitro infection with HIV to test for changes in susceptibility to virus infection. Concentrations of cumulative p24 production in supernatants following in vitro infection of rectal biopsies correlate with viral infection and replication in rectal biopsies. Therefore, lower concentrations of p24 production in biopsies collected from men receiving PrEP compared to controls indicates a potential greater protection from infection and potential increased PrEP efficacy.~For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Up to 10 months post-baseline||||ng p24||Full Range|Median
2543060|NCT02985996|Secondary|Change in Elvitegravir (EVG) Concentration in Penile Secretions|"Elvitegravir (EVG) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)||||ng/swab||Full Range|Median
2543061|NCT02985996|Secondary|Change in Tenofovir Alafenamide (TAF) Concentration in Penile Secretions|"Tenofovir alafenamide (TAF) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)|The study did not measure TAF, only the metabolite TFV||||||
2543062|NCT02985996|Secondary|Change in Tenofovir Disoproxil Fumarate (TDF) Concentration in Penile Secretions|"Tenofovir disoproxil fumarate (TDF) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)||||ng/swab||Full Range|Median
2543063|NCT02985996|Secondary|Change in Emtricitabine (FTC) Concentration in Penile Secretions|"Emtricitabine (FTC) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)||||ng/swab||Full Range|Median
2543064|NCT02985996|Secondary|Change in Elvitegravir (EVG) Concentration in Rectal Tissue|"Tissue elvitegravir (EVG) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)||||ng/mg tissue||Full Range|Median
2543065|NCT02985996|Secondary|Change in Tenofovir Alafenamide (TAF) Concentration in Rectal Tissue|"Tissue tenofovir alafenamide (TAF) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)|The study didn't measure TAF, only the metabolite TFV||||||
2543066|NCT02985996|Secondary|Change in Intracellular Tenofovir (TFV) Concentration in Rectal Tissue|"Intracellular tenofovir (TFV) Concentration in Rectal Tissue is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)||||fmol/mg tissue||Full Range|Median
2543067|NCT02985996|Secondary|Change in Intracellular Emtricitabine (FTC) Concentration in Rectal Tissue|"Tissue emtricitabine (FTC) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)||||fmol/mg tissue||Full Range|Median
2543068|NCT02985996|Secondary|Change in Intracellular Elvitegravir (EVG) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)|"Intracellular elvitegravir (EVG) concentration is measured from isolated PBMCs collected via blood draw. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)|EVG is very difficult to measure intracellularly, therefore the study only measured plasma or extracellular concentrations.||||||
2543069|NCT02985996|Secondary|Change in Intracellular Tenofovir Alafenamide (TAF) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)|"Intracellular tenofovir alafenamide (TAF) concentration is measured from isolated PBMCs collected via blood draw. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)|The study didn't measure TAF, only the metabolite TFV||||||
2543070|NCT02985996|Secondary|Change in Rectal Elvitegravir (EVG) Concentration|"Elvitegravir (EVG) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)||||ng/swab||Full Range|Median
2543163|NCT02984943|Primary|RAPID 3 - Illness/Health, 6 Months|"A questionnaire that assesses illness/health on a scale of 0-10. 0is a better outcome, and 10 is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months"|6 months||||score on a scale||Inter-Quartile Range|Median
2543071|NCT02985996|Secondary|Change in Rectal Tenofovir Alafenamide (TAF) Concentration|"Tenofovir alafenamide (TAF) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)|The study didn't measure TAF, only the metabolite TFV||||||
2543072|NCT02985996|Secondary|Change in Rectal Tenofovir Disoproxil Fumarate (TDF) Concentration|"Tenofovir disoproxil fumarate (TDF), concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)||||ng/swab||Full Range|Median
2543073|NCT02985996|Secondary|Change in Rectal Emtricitabine (FTC) Concentration|"Emtricitabine (FTC) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)||||ng/swab||Full Range|Median
2543074|NCT02985996|Secondary|Change in Plasma Elvitegravir (EVG) Concentration|"Plasma elvitegravir (EVG) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)||||ng/mL||Full Range|Median
2543075|NCT02985996|Secondary|Change in Plasma Tenofovir Alafenamide (TAF) Concentration|"Plasma tenofovir alafenamide (TAF) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)|TAF was not measured, only the metabolite TFV was measured||||||
2543076|NCT02985996|Secondary|Change in Plasma Tenofovir Disoproxil Fumarate (TDF) Concentration|"Plasma tenofovir disoproxil fumarate (TDF) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)||||ng/mL||Full Range|Median
2543077|NCT02985996|Secondary|Change in Plasma Emtricitabine (FTC) Concentration|"Plasma emtricitabine (FTC) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)||||ng/mL||Full Range|Median
2543078|NCT02985996|Primary|Changes in Intracellular Tenofovir Diphosphate (TFV-DP)|"Intracellular tenofovir diphosphate (TFV-DP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)||||fmol/1000000 PBMC||Full Range|Median
2543079|NCT02985996|Primary|Changes in Intracellular Emtricitabine Triphosphate (FTC-TP)|"Intracellular emtricitabine triphosphate (FTC-TP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as Below the Limit of Quantification (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration."|Baseline, Visit 4 (Up to ten days post drug)||||fmol/1000000 PBMC||Full Range|Median
2543080|NCT02985840|Secondary|Number of Participants With Resolution of Nausea and Abdominal Pain Symptoms|Effectiveness of intervention will be assessed by the resolution of symptoms via chart review|1 hour post intervention|Evaluation of this outcome (resolution of symptoms following intervention) required additional chart review, which was not collected. As such, this outcome was not collected or analyzed, and cannot be reported.||||||
2543081|NCT02985840|Primary|Number of Participants With Need for Additional Nausea Medications|Effectiveness of intervention will be assessed by the need for additional medications via chart review|1 hour post intervention|Evaluation of this outcome (need for additional medications within 1 hr of intervention) required additional chart review, which was not performed. As such, this outcome was not collected or analyzed, and cannot be reported.||||||
2543082|NCT02985827|Secondary|Sum of the Cooling Scale For Systane (r) Ultra|Participants completed the cooling scale after receiving 1 dose of Systane (r) Ultra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool.|4 minutes|All Participants Population- all participants who received both study treatments.|||units on a scale||Standard Deviation|Mean
2543083|NCT02985827|Primary|Sum of the Cooling Scale For Rohto (r) Hydra|Participants completed the cooling scale after receiving 1 dose of Rohto (r) Hydra at 6 time points (0, 0.5, 1, 2, 3, and 4 minutes post-treatment), and the scores were summed across these time points. The cooling scale was on a scale of 0 to 10, where 0=not cool and 10=very cool. The summed total was on a scale of 0= not cool and 60=very cool.|4 Minutes|All Participants Population- all participants who received both study treatments.|||units on a scale||Standard Deviation|Mean
2543084|NCT02985684|Secondary|Number of Subjects With Wire Frame Fracture|Among subjects with technical success, the number of subjects with wire frame fracture as determined by fluoroscopy at the 6-month evaluation.|6 months|Pivotal subjects with technical success and 6-month fluoroscopy evaluation|||Participants|||Count of Participants
2543085|NCT02985684|Secondary|Number of Subjects With Clinically Significant New Arrhythmia|The number of subjects with any new arrhythmia (documented on ECG) requiring hospitalization, initiation of new long-term medical therapy (persisting > 45 days), or any post-index procedure cardioversion or intervention (pacemaker, ablation, etc.) in subjects without prior history of arrhythmia, as adjudicated by the Independent Data Review Board|6 months|All pivotal subjects enrolled -- prior history of arrhythmia reported on the medical history form does not preclude assessment for, and finding of, clinically significant new arrhythmia from adjudication by the Independent Data Review Board|||Participants|||Count of Participants
2543087|NCT02985684|Secondary|Number of Subjects With 30-day IDRB-adjudicated Device- or Procedure-related SAE|Among subjects with attempted study device closure, the number of subjects experiencing one or more device- or procedure-related serious adverse events (SAEs) within 30 days post-index procedure as adjudicated by the Independent Data Review Board (IDRB)|30 days|All enrolled pivotal subjects|||Participants|||Count of Participants
2543088|NCT02985684|Secondary|Number of Subjects With Procedure Success|Among subjects with attempted study device closure, the number of subjects with technical success and measured residual defect status of occluded, small, or moderate of the target ASD at conclusion of index procedure|During procedure; median duration 67 minutes|All pivotal subjects enrolled|||Participants|||Count of Participants
2543089|NCT02985684|Secondary|Number of Subjects With Technical Success|Among subjects with attempted study device closure, the number of subjects with successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM ASD Occluder|During procedure; median duration 67 minutes|All pivotal subjects enrolled|||Participants|||Count of Participants
2543090|NCT02985684|Primary|Number of Subjects With 6-Month Composite Clinical Success|"Among subjects with attempted study device closure, the number of subjects who satisfy all of the following components:~Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM ASD Occluder~Safety Success:~Freedom from any Serious Adverse Event (SAE) related to the device or procedure as adjudicated by the Independent Data Review Board (IDRB) through 30 days post-procedure~Freedom from device events (post-procedure embolization, device removal, or other device reintervention) from completion of the implant procedure through 6 months (180 days) post-procedure~Closure Success: A clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation"|6 months|All enrolled pivotal subjects with 6-month clinical success evaluation|||Participants|||Count of Participants
2543091|NCT02985684|Primary|Number of Subjects With 6-Month Closure Success|Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation.|6 months|Pivotal subjects with technical success and 6-month clinical residual defect status evaluation|||Participants|||Count of Participants
2543092|NCT02985398|Secondary|Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit|Any samples that were positive for anti-ALD403 antibody, there was additional testing to characterize the anti-ALD403 antibody for the potential to neutralize (NAb) ALD403 activity.|Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104|Safety Population includes all participants who received study drug.|||Participants|||Count of Participants
2543093|NCT02985398|Secondary|Development of Anti-ALD403 Antibody by Visit|Serum blood samples were taken at visits to test for the development of antibodies to ALD403, or anti-drug antibodies (ADA). Participants who tested positive for anti-ALD403 antibodies at the time of the last study visit were asked to provide up to 2 additional blood samples for immunogenicity testing at approximately 3 month intervals for up to 6 months.|Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104|Safety Population includes all participants who received study drug.|||Participants|||Count of Participants
2543094|NCT02985398|Secondary|Change From Baseline of Migraine Disability Assessment (MIDAS) Total Score|"The MIDAS questionnaire measures the effect headaches have on the participant's daily functioning. MIDAS is composed of five questions that ask about the participant's performance over the past 3 months. The response to each question is provided in number of days which are summed to determine the MIDAS total score and level of disability:~0-5, MIDAS Grade I, little or no disability; 6-10, MIDAS Grade II, mild disability; 11-20, MIDAS Grade III, moderate disability; 21+, MIDAS Grade IV, severe disability;~A higher value represents a worse outcome."|Baseline to Week 12|Safety Population includes all participants who received study drug. Only participants who completed the Week 12 Visit are included|||score on a scale||Standard Deviation|Mean
2543095|NCT02985398|Secondary|Change in Most Bothersome Symptom at Week 48|The Investigator verbally obtained the most bothersome symptom associated with the participant's migraine during the screening visit. The most bothersome symptom may include nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, or other migraine related symptoms. Participants were asked to rate the improvement in this symptom from screening on a seven-point scale.|Baseline to Week 48|Safety Population includes all participants who received study drug. Only participants who completed the Week 48 Visit are included|||Participants|||Count of Participants
2543096|NCT02985398|Secondary|Change in Baseline of Headache Impact Test (HIT-6) Score|The HIT-6 measures the impact of headache on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assess over the prior 12-week period. The total possible scores range from 36 (no impact) to 78 (worst impact). The change in baseline will be calculated from the average scores.|Baseline, Week 1-4, Week 9-12|Safety Population includes all participants who received study drug. Only participants who completed the Week 12 Visit are included|||score on a scale||Standard Deviation|Mean
2543097|NCT02985398|Secondary|Health Related Quality of Life (EQ-5D-5L) at Week 12|The EQ-5D-5L is a descriptive health-related quality of life states consisting of 5 dimensions/questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.|Week 12|Safety Population includes all participants who received study drug. Only participants who completed the Week 12 Visit are included|||Participants|||Count of Participants
2543098|NCT02985398|Secondary|Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores|The SF-36 is a health survey consisting of 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks (scale range: 0=worst to 100=best). Increases from baseline indicate improvement.|Baseline to Week 12|Safety Population includes all participants who received study drug. Only participants who completed the Week 12 Visit are included|||score on a scale||Standard Deviation|Mean
2543125|NCT02984982|Secondary|Absolute Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 36|Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and baseline Lp(a) value as continuous fixed covariate.|Baseline, Week 36|Participants of the mITT population with one baseline and post-baseline Lp(a) values.|||mg/dL||Standard Error|Mean
2543099|NCT02985398|Secondary|Patient Global Impression of Change (PGIC) at Week 104|The PGIC includes a single question concerning the participant's impression of the change in their disease status since the start of the study. Seven responses are possible: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.|Week 104|Safety Population includes all participants who received study drug. Only participants who completed the Week 104 Visit are included|||Participants|||Count of Participants
2543100|NCT02985398|Primary|Number of Participants With Any Clinically Significant (CS) Changes in Vital Signs|Changes in vital signs that were considered clinically meaningful or clinically significant (CS) by the Investigator|104 Weeks|Safety Population includes all participants who received study drug.|||Participants|||Count of Participants
2543101|NCT02985398|Primary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior on Columbia-Suicide Severity Rating Scale (C-SSRS)|Baseline responses are collected at screening and assess suicidal ideation in the past 6 months. Post baseline reports the worst assessment of suicidal ideation since the last visit for all post baseline visits.|104 Weeks|Safety Population includes all participants who received study drug.|||Participants|||Count of Participants
2543102|NCT02985398|Primary|Number of Participants With Any Clinically Significant Laboratory Values|Each of the laboratory values that were reported as abnormal and clinically significant and entered as adverse events in the database.|104 Weeks|Safety Population includes all participants who received study drug.|||Participants|||Count of Participants
2543103|NCT02985398|Primary|Number of Participants With a Clinically Significant Electrocardiogram|Overall investigator interpretation of participant electrocardiogram|Baseline, Day 0 Postdose, Week 12, 24, 36, 48 60, 72 and 84 (Predose and Postdose), and Week 104|Safety Population includes all participants who received study drug.|||Participants|||Count of Participants
2543104|NCT02985398|Primary|Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)|Treatment emergent adverse events were defined as adverse events with start date and time on or after the date and time of the initial study drug infusion.|104 Weeks|Safety Population includes all participants who received study drug.|||Participants|||Count of Participants
2543105|NCT02984995|Secondary|Change in the Time to Reach Maximum Plasma Concentration (Tmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML||Cycle 1, Days 1 and 15; Cycle 2, Day 1|Pharmacokinetic (PK) parameters were assessed in the PK Analysis Set.|||h||Full Range|Median
2543106|NCT02984995|Secondary|Change in the Trough Plasma Concentration (Ctrough) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML||Cycle 1, Day 15|Pharmacokinetic (PK) parameters were assessed in the PK Analysis Set.|||ng/mL||Standard Deviation|Mean
2543107|NCT02984995|Secondary|Change in the Maximum Plasma Concentration (Cmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML||Cycle 1, Days 1 and 15; Cycle 2, Day 1|Pharmacokinetic (PK) parameters were assessed in the PK Analysis Set.|||ng/mL||Standard Deviation|Mean
2543108|NCT02984995|Secondary|Change in the Area Under the Plasma Concentration Time Curve (AUC) of Quizartinib and Its Active Metabolite After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML||Cycle 1, Days 1 and 15; Cycle 2, Day 1|Pharmacokinetic (PK) parameters were assessed in the PK Analysis Set.|||ng*h/mL||Standard Deviation|Mean
2543109|NCT02984995|Secondary|Hematopoietic Stem Cell Transplantation Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML|Proportion of participants who start hematopoietic stem cell transplantation (HSCT) immediately after the end of treatment with the study drug without receiving other treatment for AML, except for conditioning regiment for HSCT, was assessed.|Up to new AML treatment or 1 year post treatment|All participants with FLT3-ITD positive relapsed or refractory AML who underwent HSCT after treatment.|||Percentage of participants||95% Confidence Interval|Number
2543110|NCT02984995|Secondary|Leukemia-free Survival (LFS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML|Leukemia-free survival (LFS) is the time from the first documented response of CRc until documented relapse or death from any cause. The analysis for LFS will be conditional on the participant having a documented best response of CRc.|Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML therapy including transplantation up to 28 weeks|All participants with FLT3-ITD positive relapsed or refractory AML and documented best response of CRc.|||weeks||95% Confidence Interval|Median
2543111|NCT02984995|Secondary|Event-free Survival (EFS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML|Event-free survival is defined as the time from date of registration until documented refractory disease, relapse after response of composite complete remission (CRc = complete remission [CR], CR with incomplete platelet recovery [CRp], or CR with incomplete hematological recovery [CRi]), or death from any cause, whichever occurs first.|Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML therapy including transplantation up to 32 weeks|All participants with FLT3-ITD positive relapsed or refractory AML.|||weeks||95% Confidence Interval|Median
2543112|NCT02984995|Secondary|Overall Survival (OS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML|OS is defined as the time from registration (enrollment) until death from any cause.|Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML therapy including transplantation up to 1 year|All participants with FLT3-ITD positive relapsed or refractory AML.|||weeks||95% Confidence Interval|Median
2543113|NCT02984995|Secondary|Duration of Composite Complete Remission (CRc) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML|Duration from the date of first composite complete remission (CRc) (complete remission [CR], CR with incomplete platelet recovery [CRp], or CR with incomplete hematological recovery [CRi]) observed to the date of documented relapse was assessed.|Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 up until the end of treatment, except for responses from any subsequent AML therapy including transplantation|All participants with FLT3-ITD positive relapsed or refractory AML who had a documented best response of CRc.|||weeks||95% Confidence Interval|Median
2543114|NCT02984995|Secondary|Response Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML||Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML|All participants with FLT3-ITD positive relapsed or refractory AML who achieved CR, CRp, CRi, or PR, discontinued the study treatment, or completed response assessment at Cycle 4 Day 1.|||percentage of participants||95% Confidence Interval|Number
2543115|NCT02984995|Secondary|Best Response After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML|Best response is defined as the best measured response over all response assessments (complete response [CR], CR with incomplete platelet recovery [CRp], CR with incomplete hematological recovery [CRi], partial remission [PR], no response [NR], or Unknown) at all time points after the first dose of the study drug to the end of treatment (does not include response from any subsequent AML therapy including transplantation).|Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML|All participants with FLT3-ITD positive relapsed or refractory AML who achieved CR, CRp, CRi, or PR, discontinued the study treatment, or completed response assessment at Cycle 4 Day 1.|||Participants|||Count of Participants
2543116|NCT02984995|Primary|Composite Complete Remission (CRc) Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML|The composite complete remission (CRc) rate is defined as the proportion of participants whose best response is complete remission [CR], CR with incomplete platelet recovery [CRp], or CR with incomplete hematological recovery [CRi]) after treatment with quizartinib.|Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 up until the end of treatment, except for responses from any subsequent AML therapy including transplantation|All participants with FLT3-ITD positive relapsed or refractory AML who achieved CR, CRp, or CRi, discontinued the study treatment, or completed response assessment at Cycle 4 Day 1.|||percentage of participants||90% Confidence Interval|Number
2543117|NCT02984982|Secondary|Number of Participants With Cardiovascular (CV) Adverse Events|The suspected or confirmed CV events that occurred from randomization until end of the study visit were collected and reported. The various CV events included CV death, myocardial infarction, ischemic stroke, unstable angina requiring hospitalization , congestive heart failure requiring hospitalization, congestive heart failure requiring hospitalization, ischemia-driven coronary revascularization procedure.|Up to 36 weeks|Safety population: all participants who actually received at least 1 dose or part of a dose of the study drug, and analyzed according to the treatment actually received.|||Participants|||Count of Participants
2543118|NCT02984982|Secondary|Percent Change From Baseline in Apolipoprotein A-1 at Week 36|Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo A-1 value as continuous fixed covariate.|Baseline, Week 36|Participants of the mITT population with one baseline and one post-baseline Apo A-1 values.|||percent change||Standard Error|Least Squares Mean
2543119|NCT02984982|Secondary|Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 36|Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo A-1 value as continuous fixed covariate.|Baseline, Week 36|Participants of the mITT population with one baseline and one post-baseline Apo A-1 values.|||mg/dL||Standard Error|Least Squares Mean
2543120|NCT02984982|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 36|Adjusted mean and SE were obtained by multiple imputation approach followed by robust regression model included fixed categorical effect of treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) and the continuous fixed covariate of baseline fasting TGs value.|Baseline, Week 36|Participants of the mITT population with one baseline and at least one post-baseline fasting TGs values.|||percent change||Standard Error|Mean
2543121|NCT02984982|Secondary|Absolute Change From Baseline in Fasting Triglycerides (TGs) at Week 36|Adjusted mean and SE were obtained from multiple imputation approach followed by robust regression model including fixed categorical effect of treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) and the continuous fixed covariate of baseline fasting TGs value.|Baseline, Week 36|Participants of the mITT population with one baseline and at least one post-baseline fasting TGs values.|||mg/dL||Standard Error|Mean
2543122|NCT02984982|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol at Week 36|Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline HDL-C value and baseline HDL-C value-by-time point interaction as continuous fixed covariates.|Baseline, Week 36|Participants of the mITT population with one baseline and at least one post-baseline HDL-C values.|||percent change||Standard Error|Least Squares Mean
2543123|NCT02984982|Secondary|Absolute Change From Baseline in High-density Lipoprotein Cholesterol at Week 36|Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline HDL-C value and baseline HDL-C value-by-time point interaction as continuous fixed covariates.|Baseline, Week 36|Participants of the mITT population with one baseline and at least one post-baseline HDL-C values.|||mg/dL||Standard Error|Least Squares Mean
2543124|NCT02984982|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 36|Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and baseline Lp(a) value as continuous fixed covariate.|Baseline, Week 36|Participants of the mITT population with one baseline and one post-baseline Lp(a) values.|||percent change||Standard Error|Mean
2543138|NCT02984982|Secondary|Absolute Change From Baseline in Normalized Total Atheroma Volume at Week 36|LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline normalized TAV as continuous fixed covariate.|Baseline, Week 36|mITT population.|||cubic millimeter (mm^3)||Standard Error|Least Squares Mean
2543126|NCT02984982|Secondary|Percent Change From Baseline in Total Cholesterol at Week 36|Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline TC value and baseline TC value-by-time point interaction as continuous fixed covariates.|Baseline, Week 36|Participants of the mITT population with one baseline and at least one post-baseline TC values.|||percent change||Standard Error|Least Squares Mean
2543127|NCT02984982|Secondary|Absolute Change From Baseline in Total Cholesterol (TC) at Week 36|LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated TC value and baseline calculated TC value-by-time point interaction as continuous fixed covariates.|Baseline, Week 36|Participants of the mITT population with one baseline and at least one post-baseline TC values.|||mg/dL||Standard Error|Least Squares Mean
2543128|NCT02984982|Secondary|Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol at Week 36|Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated non-HDL-C value and baseline calculated non-HDL-C value-by-time point interaction as continuous fixed covariates.|Baseline, Week 36|Participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C values.|||percent change||Standard Error|Least Squares Mean
2543129|NCT02984982|Secondary|Absolute Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 36|Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated non-HDL-C value and baseline calculated non-HDL-C value-by-time point interaction as continuous fixed covariates.|Baseline, Week 36|Participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C values.|||mg/dL||Standard Error|Least Squares Mean
2543130|NCT02984982|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 36|Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo B value as continuous fixed covariate.|Baseline, Week 36|Participants of the mITT population with one baseline and one post-baseline Apo B values.|||percent change||Standard Error|Least Squares Mean
2543131|NCT02984982|Secondary|Absolute Change From Baseline in Apolipoprotein B (Apo B) at Week 36|Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo B value as continuous fixed covariate.|Baseline, Week 36|Participants of the mITT population with one baseline and one post-baseline Apo B values.|||mg/dL||Standard Error|Least Squares Mean
2543132|NCT02984982|Secondary|Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36|Adjusted LS mean and SE at Week 12 and Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated LDL-C value and baseline calculated LDL-C value-by-time point interaction as continuous fixed covariates.|Baseline, Week 12, Week 36|mITT population with one baseline and at least one post-baseline calculated LDL-C values.|||percent change||Standard Error|Least Squares Mean
2543133|NCT02984982|Secondary|Absolute Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36|Adjusted LS mean and SE at Week 12 and Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated LDL-C value and baseline calculated LDL-C value-by-time point interaction as continuous fixed covariates.|Baseline, Week 12, Week 36|Participants of the mITT population with one baseline and at least one post-baseline calculated LDL-C values.|||mg/dL||Standard Error|Least Squares Mean
2543134|NCT02984982|Secondary|Percent Change From Baseline in Lumen Volume at Week 36|Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and the baseline lumen volume value as continuous fixed covariate.|Baseline, Week 36|mITT population.|||percent change||Standard Error|Mean
2543135|NCT02984982|Secondary|Absolute Change From Baseline in Lumen Volume at Week 36|Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline lumen volume value as continuous fixed covariate.|Baseline, Week 36|mITT population.|||mm^3||Standard Error|Mean
2543136|NCT02984982|Secondary|Percent Change From Baseline in External Elastic Membrane Volume at Week 36|Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline EEM volume value as continuous fixed covariate.|Baseline, Week 36|mITT population.|||percent change||Standard Error|Mean
2543137|NCT02984982|Secondary|Absolute Change From Baseline in External Elastic Membrane (EEM) Volume at Week 36|Adjusted mean and SE at Week 36 were obtained from robust regression model with treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]), as fixed categorical effects, and the baseline EEM volume value as continuous fixed covariate.|Baseline, Week 36|mITT population.|||mm^3||Standard Error|Mean
2543139|NCT02984982|Secondary|Absolute Change From Baseline in Percent Atheroma Volume (PAV) at Week 36|LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline PAV as continuous fixed covariate.|Baseline, Week 36|mITT population.|||percent atheroma volume||Standard Error|Least Squares Mean
2543140|NCT02984982|Primary|Percent Change From Baseline in Normalized Total Atheroma Volume (TAV) at Week 36|Least-squares (LS) means and standard errors (SE) at Week 36 were obtained from analysis of covariance (ANCOVA) model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline normalized TAV as continuous fixed covariate.|Baseline, Week 36|Modified intent-to-treat (mITT) population: all participants who were allocated to a randomized treatment, recorded in the registration center database, had at least one dose or part of dose of study drug and had 2 analyzable normalized TAV values, 1 assessed before randomization, and one assessed after 24 weeks of treatment.|||percent change||Standard Error|Least Squares Mean
2543141|NCT02984943|Primary|Ultrasound - Synovitis, Combined Score (CS), Left, 6 Months|"Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. 0 is best outcome, 3worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered improved for the t month time point. The number of participants with improved scores will be added to form the total number with improvement at t months"|6 months|10 participants imaged. 1 unable to analyze due to fusion on imaging.|||Participants|||Count of Participants
2543142|NCT02984943|Primary|Ultrasound - Synovitis, Combined Score (CS), Left, 3 Months|"Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. 0 is best outcome, 3worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered improved for the 3 month time point. The number of participants with improved scores will be added to form the total number with improvement at 3 months"|3 months|10 participants imaged. 1 unable to analyze due to fusion on imaging.|||Participants|||Count of Participants
2543143|NCT02984943|Primary|Ultrasound - Synovitis, Combined Scale (CS), Right - 6 Months|"Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. 0 is best outcome, 3worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered improved for the 6 month time point. The number of participants with improved scores will be added to form the total number with improvement at 6 months"|6 months|10 participants imaged. 1 unable to analyze due to fusion on imaging.|||Participants|||Count of Participants
2543144|NCT02984943|Primary|Ultrasound - Synovitis, Combined Score (CS), Right, 3 Months|"Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. 0 is best outcome, 3worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered improved for the 3 month time point. The number of participants with improved scores will be added to form the total number with improvement at 3 months"|3 months|10 participants imaged. 1 unable to analyze due to fusion on imaging.|||Participants|||Count of Participants
2543145|NCT02984943|Primary|MRI - Oedema, Combined Score (CS), Right, 6 Months|"Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. 0 is best outcome, 3worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered improved for the 6 month time point. The number of participants with improved scores will be added to form the total number with improvement at 6 months"|6 months|10 participants imaged. 1 unable to analyze due to fusion on imaging.|||Participants|||Count of Participants
2543146|NCT02984943|Primary|MRI - Oedema, Combined Score (CS), Right, 3 Months|"Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. 0 is best outcome, 3worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered improved for the 3 month time point. The number of participants with improved scores will be added to form the total number with improvement at 3 months"|3 months|10 participants imaged. 1 unable to analyze due to fusion on imaging.|||Participants|||Count of Participants
2543147|NCT02984943|Primary|MRI - Oedema, Combined Score (CS), Left, 6 Months|"Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. 0 is best outcome, 3worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered improved for the 6 month time point. The number of participants with improved scores will be added to form the total number with improvement at 6 months"|6 months|10 participants imaged. 1 unable to analyze due to fusion on imaging.|||Participants|||Count of Participants
2543148|NCT02984943|Primary|MRI - Oedema, Combined Score (CS), Left, 3 Months|"Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. 0 is best outcome, 3worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered improved for the 3 month time point. The number of participants with improved scores will be added to form the total number with improvement at 3 months"|3 months|10 participants imaged. 1 unable to analyze due to fusion on imaging.|||Participants|||Count of Participants
2543149|NCT02984943|Primary|MRI - Bone Erosion, Combined Score (CS), Left, 6 Months|"Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. 0 is best outcome, 10worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a higher median score at 6 months relative to baseline will be considered improved for the 6 month time point. The number of participants with improved scores will be added to form the total number with improvement at 6 months"|6 months|10 participants imaged. 1 unable to analyze due to fusion on imaging|||Participants|||Count of Participants
2543150|NCT02984943|Primary|MRI - Bone Erosion, Combined Score (CS), Left, 3 Months|"Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. 0 is best outcome, 10worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a higher median score at 3 months relative to baseline will be considered improved for the 3 month time point. The number of participants with improved scores will be added to form the total number with improvement at 3 months"|3 months|10 participants imaged. 1 unable to analyze due to fusion on imaging|||Participants|||Count of Participants
2543151|NCT02984943|Primary|MRI - Bone Erosion, Combined Score (CS), Right, 6 Months|"Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. 0 is best outcome, 10worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a higher median score at 6 months relative to baseline will be considered improved for the 6 month time point. The number of participants with improved scores will be added to form the total number with improvement at 6 months"|6 months|10 participants imaged. 1 unable to analyze due to fusion on imaging|||Participants|||Count of Participants
2543152|NCT02984943|Primary|MRI - Bone Erosion, Combined Score (CS), Right, 3 Months|"Each of the 23 joints in the hand/wrist will be assigned a score from 0-10 based on the proportion of bone involved. 0 is best outcome, 10worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a higher median score at 3 months relative to baseline will be considered improved for the 3 month time point. The number of participants with improved scores will be added to form the total number with improvement at 3 months"|3 months|10 participants imaged. 1 unable to analyze due to fusion on imaging|||Participants|||Count of Participants
2543153|NCT02984943|Primary|MRI - Synovitis, Combined Score (CS), Left, 6 Months|"Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. 0 is best outcome, 3worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered improved for the 6 month time point. The number of participants with improved scores will be added to form the total number with improvement at 6 months"|6 months|10 participants imaged. 1 unable to analyze due to fusion on imaging.|||Participants|||Count of Participants
2543154|NCT02984943|Primary|MRI - Synovitis, Combined Score (CS), Left, 3 Months|"Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. 0 is best outcome, 3worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered improved for the 3 month time point. The number of participants with improved scores will be added to form the total number with improvement at 3 months"|3 months|10 participants imaged. 1 unable to analyze due to fusion on imaging.|||Participants|||Count of Participants
2543155|NCT02984943|Primary|MRI - Synovitis, Combined Score (CS), Right, 6 Months|"Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. 0 is best outcome, 3worse outcome. The median score of all 23 joints at baseline and 6 months will then be calculated for each participant. Participants with a lower median score at 6 months relative to baseline will be considered improved for the 6 month time point. The number of participants with improved scores will be added to form the total number with improvement at 6 months"|6 months|10 participants imaged. 1 unable to analyze due to fusion on imaging.|||Participants|||Count of Participants
2543156|NCT02984943|Primary|MRI - Synovitis, Combined Score (CS), Right, 3 Months|"Each of the 23 joints in the hand/wrist will be assigned a score from 0-3 based on the proportion of bone involved. 0 is best outcome, 3worse outcome. The median score of all 23 joints at baseline and 3 months will then be calculated for each participant. Participants with a lower median score at 3 months relative to baseline will be considered improved for the 3 month time point. The number of participants with improved scores will be added to form the total number with improvement at 3 months"|3 months|10 participants imaged. 1 unable to analyze due to fusion on imaging|||Participants|||Count of Participants
2543157|NCT02984943|Primary|VAS Pain Scale - 6 Months|"A pain assessment using a horizontal line with numbers, 0-10, along the axis with endpoints no pain to worse possible pain. 0is a better outcome, and 10 is a worse outcome. Participants will mark on the line the level of pain they are experiencing now. The value for each participant will be combined to report a median and inter-quartile range at 6 months"|6 months||||score on a scale||Inter-Quartile Range|Median
2543158|NCT02984943|Primary|VAS Pain Scale - 6 Weeks|"A pain assessment using a horizontal line with numbers, 0-10, along the axis with endpoints no pain to worse possible pain. 0is a better outcome, and 10 is a worse outcome. Participants will mark on the line the level of pain they are experiencing now. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks"|6 weeks||||score on a scale||Inter-Quartile Range|Median
2543159|NCT02984943|Primary|RAPID 3 - Weighed Scores, 6 Months|The cumulative score conversion (based on a table). Recorded as a number between 0-10. 0-1 is near remission, 1.3-2 is low severity, 2.3 -4 is moderate severity, and 4.3 - 10 is high severity. The value for each participant will be combined to report a median and inter-quartile range at 6 months|6 months||||score on a scale||Inter-Quartile Range|Median
2543160|NCT02984943|Primary|RAPID 3 - Weighed Scores, 6 Weeks|The cumulative score conversion (based on a table). Recorded as a number between 0-10. 0-1 is near remission, 1.3-2 is low severity, 2.3 -4 is moderate severity, and 4.3 - 10 is high severity. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks|6 weeks||||score on a scale||Inter-Quartile Range|Median
2543161|NCT02984943|Primary|RAPID 3 - Cumulative Scores, 6 Months|"The combined abilities, pain and illness/health scores. Recorded as a number between 0-30. 0is a better outcome, and 30 is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months"|6 months||||score on a scale||Inter-Quartile Range|Median
2543162|NCT02984943|Primary|RAPID 3 - Cumulative Scores, 6 Weeks|"The combined abilities, pain and illness/health scores. Recorded as a number between 0-30. 0is a better outcome, and 30 is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks"|6 weeks||||score on a scale||Inter-Quartile Range|Median
2543164|NCT02984943|Primary|RAPID 3 - Illness/Health, 6 Weeks|"A questionnaire that assesses illness/health on a scale of 0-10. 0is a better outcome, and 10 is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks"|6 weeks||||score on a scale||Inter-Quartile Range|Median
2543165|NCT02984943|Primary|RAPID 3 - Pain, 6 Months|"A questionnaire that assesses pain on a scale of 0-10. 0is a better outcome, and 10 is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months"|6 months||||score on a scale||Inter-Quartile Range|Median
2543166|NCT02984943|Primary|RAPID 3 - Pain, 6 Weeks|"A questionnaire that assesses pain on a scale of 0-10. 0is a better outcome, and 10 is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks"|6 weeks||||score on a scale||Inter-Quartile Range|Median
2543167|NCT02984943|Primary|RAPID 3 - Abilities, 6 Months|"A questionnaire that assesses abilities on a scale of 0-10. 0is a better outcome, and 10 is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months"|6 months||||score on a scale||Inter-Quartile Range|Median
2543168|NCT02984943|Primary|RAPID 3 - Abilities, 6 Weeks|"A questionnaire that assesses abilities on a scale of 0-10. 0is a better outcome, and 10 is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks."|6 weeks||||score on a scale||Inter-Quartile Range|Median
2543169|NCT02984943|Primary|DAS28 - Erythrocyte Sedimentation Rate (ESR), 6 Months|"DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), ESR (mm/h) and visual analogue scales (VAS) for patient global assessment of well-being (0-100 mm). 0is a better outcome, and 100 is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 months"|6 months||||score on a scale||Inter-Quartile Range|Median
2543170|NCT02984943|Primary|DAS28 - Erythrocyte Sedimentation Rate (ESR), 3 Months|"DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), ESR (mm/h) and visual analogue scales (VAS) for patient global assessment of well-being (0-100 mm). 0is a better outcome, and 100 is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 3 months"|3 months||||score on a scale||Inter-Quartile Range|Median
2543171|NCT02984943|Primary|DAS28 - C-reactive Protein (CRP), 6 Months|"DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), CRP (mg/L) and visual analogue scales (VAS) for patient global assessment of wellbeing (0-100 mm). 0is a better outcome, and 100 is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 months"|6 months||||score on a scale||Inter-Quartile Range|Median
2543172|NCT02984943|Primary|DAS28 - C-reactive Protein (CRP), 3 Months|"DAS28 quantifies disease activity based on a mathematical formula that computes four variables: number of swollen and tender joints (total number of joints assessed is 28), CRP (mg/L) and visual analogue scales (VAS) for patient global assessment of well-being (0-100 mm). 0is a better outcome, and 100 is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 3 months"|3 months||||score on a scale||Inter-Quartile Range|Median
2543173|NCT02984943|Primary|DAS28 - Global Health (GH), 6 Months|"DAS28 quantifies disease activity based on visual analogue scales (VAS) assessment of well-being rated on a scale of 0-100 mm. 0is a better outcome, and 100 is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 months"|6 months||||score on a scale||Inter-Quartile Range|Median
2543174|NCT02984943|Primary|DAS28 - Global Health (GH), 3 Months|"DAS28 quantifies disease activity based on visual analogue scales (VAS) assessment of well-being rated on a scale of 0-100 mm.0is a better outcome, and 100 is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 3 months"|3 months||||score on a scale||Inter-Quartile Range|Median
2543175|NCT02984943|Primary|Sleep Quality - Night Pain, 6 Months|"The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question How often have you been awakened by pain during the night? by placing a slash (/) on a 10 cm line directly beneath the question. The line will have never and always at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. 0is a better outcome, and 10 is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months"|6 months||||score on a scale||Inter-Quartile Range|Median
2543176|NCT02984943|Primary|Sleep Quality - Night Pain, 6 Weeks|"The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question How often have you been awakened by pain during the night? by placing a slash (/) on a 10 cm line directly beneath the question. The line will have never and always at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. 0is a better outcome, and 10 is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks"|6 weeks||||score on a scale||Inter-Quartile Range|Median
2543177|NCT02984943|Primary|Sleep Quality - Morning Pain, 6 Months|"The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question How often have you been awakened by pain during the morning? by placing a slash (/) on a 10 cm line directly beneath the question. The line will have never and always at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. 0is a better outcome, and 10 is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months"|6 months||||score on a scale||Inter-Quartile Range|Median
2543178|NCT02984943|Primary|Sleep Quality - Morning Pain, 6 Weeks|"The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question How often have you been awakened by pain during the morning? by placing a slash (/) on a 10 cm line directly beneath the question. The line will have never and always at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. 0is a better outcome, and 10 is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 weeks"|6 weeks||||score on a scale||Inter-Quartile Range|Median
2543179|NCT02984943|Primary|Sleep Quality - Trouble Falling Asleep, 6 Months|"The PSQ-3 questionnaire will be used to measure outcome. Participants will score the question How often have you had trouble falling asleep because of pain? by placing a slash (/) on a 10 cm line directly beneath the question. The line will have never and always at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. 0is a better outcome, and 10 is a worse outcome. The value for each participant will be combined to report a median and inter-quartile range at 6 months."|6 months||||score on a scale||Inter-Quartile Range|Median
2543180|NCT02984943|Primary|Sleep Quality - Trouble Falling Asleep, 6 Weeks|"The Pain Sleep Quality (PSQ)-3 questionnaire will be used to measure outcome. Participants will score the question How often have you had trouble falling asleep because of pain? by placing a slash (/) on a 10 cm line directly beneath the question. The line will have never and always at each end. A ruler will be used to determine were the slash falls. The value between, 0-10, that corresponds on the ruler with the slash will be documented. 0 is a better outcome, and 10 is a worse outcome. The value for each participant will be combined to obtain a median and inter-quartile range at 6 weeks"|6 weeks||||score on a scale||Inter-Quartile Range|Median
2543181|NCT02984878|Secondary|Patient Global Aesthetic Improvement (pGAI) Score|Subjects were evaluated on the Patient Global Aesthetic Improvement (pGAI) Patient Global Aesthetic Improvement (pGAI) Score: 1 = Worse, 2 = No change, 3 = Improved, 4 = Much improved, 5 = Very much improved|Visit 8/Week 52|Subjects were evaluated on the Patient Global Aesthetic Improvement (pGAI)|||Participants|||Count of Participants
2543182|NCT02984878|Secondary|Retreatment Safety Assessed by the Incidence of Adverse Events (AEs), Which Were Defined, Recorded, Reported, and Evaluated, by Number and Severity|Assess safety concerns with retreatment of Revanesse Ultra for men or women at least 22 years of age with NLFs with a moderate or severe WSRS score at baseline who had previously received 1 or 2 treatments with Restylane or Revanesse Ultra, Adverse Events (AEs), which were defined, recorded, reported, and evaluated|Visit 6/Week 24, Visit 7/Week 28, Visit 8/Week 52|Counts reflect numbers of subjects reporting one or more injection site TEAE that map to the MedDRA (version 15.1) system organ class/preferred term. At each level of summarization (system organ class or preferred term), subjects reporting more than one injection site TEAE are counted only once.|||Participants|||Count of Participants
2543183|NCT02984878|Primary|Change in the Wrinkle Severity Rating Scale (WSRS) With Subjects From Both the Retreatment and the Optimal Correction Groups - WSRS Scores at Visit 8/Week 52|Change in the Wrinkle Severity Rating Scale (WSRS) With Subjects From Both the Retreatment and the Optimal Correction Groups Achieving Similar WSRS Scores at Visit 8/Week 52 - WSRS Score categories: 1. Absent - No visible fold; continuous skin line. 2. Mild - Shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance. 3. Moderate - Moderately deep folds; clear facial feature visible at normal appearance but not when stretched; excellent correction is expected from injectable implant. 4. Severe - Very long and deep folds; prominent facial feature; less than 2 mm visible when stretched; significant improvement is expected from injectable implant. 5. Extreme - Extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone. An increase in the WSRS score indicates a worsening of severity.|Visit 8/Week 52|Subjects that completed the SYM 2014-02 Main Study were eligible for the SYM 2014-02 Retreatment Study.|||units on WSRS scale|Nasolabial Folds|Standard Deviation|Mean
2543184|NCT02984709|Secondary|Self Care Inventory|The Self Care Inventory measures adherence to the recommended diabetes treatment regimen. Adolescents and parents report on the adolescents' self-care behaviors. Items are summed for a total score, ranging from 7-35. Higher scores indicate higher levels of adherence.|3 months|One teen participant in the Experimental group did not complete follow-up survey data. All parents completed the follow-up surveys.|||score on a scale||Standard Deviation|Mean
2543185|NCT02984709|Secondary|Disengagement Coping|Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher levels indicate greater relative use of disengagement control coping (e.g., avoidance, denial).|3 months|One teen participant in the Experimental group did not complete follow-up survey data.|||ratio score||Standard Deviation|Mean
2543186|NCT02984709|Secondary|Secondary Control Coping|Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher levels indicate greater relative use of secondary control coping (e.g., acceptance, distraction, positive thinking).|3 months|One teen participant in the Experimental group did not complete follow-up survey data.|||ratio score||Standard Deviation|Mean
2543187|NCT02984709|Secondary|Primary Control Coping|Responses to Stress Questionnaire measures coping with diabetes-related stress. Three factors of coping are measured: primary control coping, secondary control coping,and disengagement coping. A ratio score is calculated to determine the ratio of each type of coping in relation to total coping, ranging from 0.00 to 1.00. Higher scores indicate greater relative use of primary control coping (e.g., problem solving, emotional modulation).|3 months|One teen participant in the Experimental group did not complete follow-up survey data.|||ratio score||Standard Deviation|Mean
2543188|NCT02984709|Secondary|Diabetes-Specific Quality of Life|Pediatric Quality of Life Diabetes-Specific Module (PedsQL) measures quality of life. A mean scaled score is calculated, ranging from 0-100, with higher values indicating better quality of life.|3 months|One teen participant in the Experimental group did not complete follow-up survey data.|||score on a scale||Standard Deviation|Mean
2543189|NCT02984709|Secondary|Diabetes Family Conflict Scale|Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale (DRCS), which consists of 19 items regarding how much adolescents and parents argue about diabetes management tasks. Scores range from 19 to 57, and higher scores indicate greater family conflict.|3 months|One teen participant in the Experimental group did not complete follow-up survey data. All parents completed the follow-up surveys.|||score on a scale||Standard Deviation|Mean
2554601|NCT02756689|Secondary|Total Hospital Duration||From admission time to the hospital until discharge from the hospital, up to 7 days||||days||Standard Deviation|Mean
2543190|NCT02984709|Secondary|Frequency of Blood Glucose Monitoring|Glucometer download to determine frequency of blood glucose checks per day. Higher numbers indicates more frequent blood glucose checks.|3 months|Three participants in the Experimental group and five participants in the Active Comparator group did not bring their glucometers to clinic visits and therefore frequency of blood glucose monitoring could not be obtained.|||blood glucose checks per day||Standard Deviation|Mean
2543191|NCT02984709|Secondary|Positive Affect|Positive affect measured using the Positive and Negative Affect Scale for children (PANAS-C). The positive affect scale consists of 15 items, which are summed for a total score, ranging from 15-60. Higher scores indicate higher levels of positive affect.|3 months|One teen participant in the Experimental group did not complete follow-up survey data.|||score on a scale||Standard Deviation|Mean
2543192|NCT02984709|Primary|Glycemic Control (A1C)|A1C is the percentage of glycosylated hemoglobin and represents an average of glycemic control over the previous 2-3 months.|3 months|One participant in the Active Comparator group did not return for a clinic visit and therefore did not have an A1C value at follow-up.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2543193|NCT02984644|Secondary|Change in Glucagon Using Pancreatic Clamp: Study 3|Measurement of change in plasma glucagon from baseline to one hour prior to end of study while using a pancreatic clamp. In this study, EGP will be measured as described in Study 1 and plasma insulin and glucagon concentrations will be clamped at the basal level using the pancreatic clamp technique. Plasma glucose concentration will be allowed to decrease spontaneously after dapagliflozin or placebo administration. Somastatin will be infused with glucagon and insulin to replace basal plasma glucagon and insulin until study end.|Baseline to 240-300 minutes||||ng/ml||Standard Deviation|Mean
2543194|NCT02984644|Secondary|Change in Glucagon Using Glucose Clamp: Study 2|Plasma glucagon concentration during measurement of EGP using a glucose clamp. The glucose clamp technique is achieved by increase plasma glucose concentration to 125 mg/dl above basal levels by a continuous infusion of glucose. This hyperglycemic plateau is maintained by adjustment of a variable glucose infusion, based on the rate of insulin secretion and glucose metabolism. Because the plasma glucose concentration is held constant, the glucose infusion rate is an index of insulin secretion and glucose metabolism.|Baseline to 240-300 minutes||||ng/ml||Standard Deviation|Mean
2543195|NCT02984644|Secondary|Change in Glucagon: Study 1|Change in glucagon concentrations during measurement of EGP|Baseline to 240-300 minutes||||ng/ml||Standard Deviation|Mean
2543196|NCT02984644|Secondary|Change in Plasma Insulin While Using Pancreatic Clamp: Study 3|Plasma insulin concentration during measurement of EGP while using pancreatic clamp. In this study, EGP will be measured as described in Study 1 and plasma insulin and glucagon concentrations will be clamped at the basal level using the pancreatic clamp technique. Plasma glucose concentration will be allowed to decrease spontaneously after dapagliflozin or placebo administration. Somastatin will be infused with glucagon and insulin to replace basal plasma glucagon and insulin until study end.|Baseline to last hour of the study||||microUnits/mL||Standard Deviation|Mean
2543197|NCT02984644|Secondary|Plasma Insulin Concentrations During Measurement of EGP Plus Glucose Clamp: Study 2|Plasma insulin concentration is measured from baseline to the last hour of the study while using a glucose clamp. The glucose clamp technique is achieved by increase plasma glucose concentration to 125 mg/dl above basal levels by a continuous infusion of glucose. This hyperglycemic plateau is maintained by adjustment of a variable glucose infusion, based on the rate of insulin secretion and glucose metabolism. Because the plasma glucose concentration is held constant, the glucose infusion rate is an index of insulin secretion and glucose metabolism. The 3-3H-glucose infusion will be started at 6 AM to measure the basal rate of EGP. After a 3 hour tracer equilibration period (at 9 AM) subjects will receive dapagliflozin (10 mg) or placebo, and the plasma glucose conc will be measured every 5 minutes for 5 hours (from 9AM to 2 PM)|Baseline to 240-300 minutes||||microUnits/mL||Standard Deviation|Mean
2543198|NCT02984644|Secondary|Change in Plasma Insulin Concentrations: Study 1|Plasma insulin concentrations during measurement of EGP|Baseline to 240-300 minutes||||microUnits/mL||Standard Deviation|Mean
2543199|NCT02984644|Primary|Change in EGP With Pancreatic Clamp: Study 3|Change from baseline to the last hour of the study (240-300 minutes) of EGP with a pancreatic clamp. In this study, EGP will be measured as described in Study 1 and plasma insulin and glucagon concentrations will be clamped at the basal level using the pancreatic clamp technique. Plasma glucose concentration will be allowed to decrease spontaneously after dapagliflozin or placebo administration. Somastatin will be infused with glucagon and insulin to replace basal plasma glucagon and insulin until study end.VIn this study, EGP will be measured as described in Study 1 and plasma insulin and glucagon concentrations will be clamped at the basal level using the pancreatic clamp technique. Plasma glucose concentration will be allowed to decrease spontaneously after dapagliflozin or placebo administration. Somastatin will be infused with glucagon and insulin to replace basal plasma glucagon and insulin until study end.|Baseline to 240-300 minutes||||mg/kg.min||Standard Deviation|Mean
2543200|NCT02984644|Primary|Change in EGP With Glucose Clamp: Study 2|Change from baseline to the last hour of the study (240-300 minutes) in EGP using a glucose clamp. The glucose clamp technique is achieved by increase plasma glucose concentration to 125 mg/dl above basal levels by a continuous infusion of glucose. This hyperglycemic plateau is maintained by adjustment of a variable glucose infusion, based on the rate of insulin secretion and glucose metabolism. Because the plasma glucose concentration is held constant, the glucose infusion rate is an index of insulin secretion and glucose metabolism. The 3-3H-glucose infusion will be started at 6 AM to measure the basal rate of EGP. After a 3 hour tracer equilibration period (at 9 AM) subjects will receive dapagliflozin (10 mg) or placebo, and the plasma glucose conc will be measured every 5 minutes for 5 hours (from 9AM to 2 PM)|Baseline to 240-300 minutes||||mg/kg.min||Standard Deviation|Mean
2543201|NCT02984644|Primary|Change in EGP: Study 1|Change from baseline to the last hour of the study (240-300 minutes) in EGP|Baseline to 240-300 minutes||||mg/kg.min||Standard Deviation|Mean
2543202|NCT02984644|Primary|Change in Plasma Glucose Using a Pancreatic Clamp: Study 3|Change from Baseline to the last hour of the study (240-300 minutes) in plasma glucose using a pancreatic clamp. In this study, EGP will be measured as described in Study 1 and plasma insulin and glucagon concentrations will be clamped at the basal level using the pancreatic clamp technique. Plasma glucose concentration will be allowed to decrease spontaneously after dapagliflozin or placebo administration. Somastatin will be infused with glucagon and insulin to replace basal plasma glucagon and insulin until study end.|Baseline to 240-300 minutes||||mg/dl||Standard Deviation|Mean
2543203|NCT02984644|Primary|Change in Plasma Glucose Measurement Using a Glucose Clamp: Study 2|Change from baseline to the last hour of the study (240-300 minutes) in plasma glucose for study 2: EGP plus glucose clamp. The glucose clamp technique is achieved by increase plasma glucose concentration to 125 mg/dl above basal levels by a continuous infusion of glucose. This hyperglycemic plateau is maintained by adjustment of a variable glucose infusion, based on the rate of insulin secretion and glucose metabolism. Because the plasma glucose concentration is held constant, the glucose infusion rate is an index of insulin secretion and glucose metabolism. The 3-3H-glucose infusion will be started at 6 AM to measure the basal rate of EGP. After a 3 hour tracer equilibration period (at 9 AM) subjects will receive dapagliflozin (10 mg) or placebo, and the plasma glucose conc will be measured every 5 minutes for 5 hours (from 9AM to 2 PM)|Baseline to 240-300 minutes||||mg/dl||Standard Deviation|Mean
2543204|NCT02984644|Primary|Measurement of the Change in Plasma Glucose (mg/dL): Study 1|Change from baseline to the last hour of the study (240-300 minutes) in plasma glucose concentration|Baseline to 240-300 minutes||||mg/dl||Standard Deviation|Mean
2543205|NCT02984267|Secondary|Overall Anesthesia Experience Satisfaction|Within 24 hours after delivery, patients will be given a 13 question survey. The survey is a modified Woman's Views of Birth Labor Satisfaction Questionnaire (WOMBLSQ) which asks patients to rate 13 various satisfaction related statements on a 1-7 scale, with 1 being totally disagree, 4 being neither agree nor disagree, and 7 being totally agree. Each of the 13 questions asked are designed to assess their overall satisfaction with their epidural catheter placement and overall anesthesia care. The total score is reported combining all 13 questions for a possible score range of 13-91. A higher total score indicates a higher overall anesthesia experience satisfaction level. No subscales were used.|Measured within 24 hours of delivery||||Units on a scale||Standard Deviation|Mean
2543206|NCT02984267|Secondary|Palpation or Ultrasound Time|The time taken to evaluate the spine, either by palpation or ultrasound guidance, and mark the location for epidural catheter insertion|Assessed immediately prior to epidural catheter placement||||Minutes||Standard Deviation|Mean
2543207|NCT02984267|Secondary|Patient Anxiety Level|Immediately following epidural catheter placement, patients will be asked to rate their anxiety level during the procedure on a 0-10 scale, where 0 is no anxiety at all, and 10 is the worst anxiety imaginable.|Assessed immediately following epidural catheter placement||||Units on a scale||Standard Deviation|Mean
2543208|NCT02984267|Secondary|Epidural Catheter Placement Satisfaction Level|Immediately following epidural catheter placement, patients will be asked to rate their satisfaction level during the procedure on a 0-10 scale, with 0 being not at all satisfied, and 10 being extremely satisfied.|Assessed immediately following epidural catheter placement||||Units on a scale||Standard Deviation|Mean
2543209|NCT02984267|Secondary|Epidural Failure Rate|Any epidural catheter that fails to provide appropriate analgesia requiring them to be replaced with a new epidural catheter will be documented and reported|Assessed within 24 hours after delivery||||Participants|||Count of Participants
2543210|NCT02984267|Secondary|Complications|Any epidural related complication noted to occur including a failed epidural, inadvertent dural puncture, or paresthesia will be documented and reported.|Assessed immediately during epidural catheter placement and within 24 hours after delivery||||Complications|||Number
2543211|NCT02984267|Secondary|Number of Participants Who Had Successful Placement of the Epidural Catheter in the First Attempt||Assessed immediately during epidural catheter placement||||Participants|||Count of Participants
2543212|NCT02984267|Secondary|Number of Attempts at Epidural Catheter Placement||Assessed immediately during epidural catheter placement||||Number of attempts||Inter-Quartile Range|Median
2543213|NCT02984267|Secondary|Epidural Procedure Time|Time required to successfully place the epidural catheter|Assessed immediately during epidural catheter placement||||Minutes||Standard Deviation|Mean
2543214|NCT02984267|Primary|Total Time Required for Epidural Catheter Placement|Includes the time required to evaluate the spine (via ultrasound or palpation) plus the time required to successfully place the epidural catheter|Assessed immediately during epidural catheter placement||||Minutes||Standard Deviation|Mean
2543215|NCT02983981|Secondary|Dermatology Life Quality Index|calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.|16 weeks||||units on a scale||Standard Deviation|Mean
2543216|NCT02983981|Secondary|Psoriasis Severity|Psoriasis severity measured as Body Surface area measured as 1 of patient's palm is equal to 1% body surface area.|16 weeks||||percentage of BSA||Standard Deviation|Mean
2543217|NCT02983981|Secondary|Psoriasis Severity|Physician's Global Assessment Scores Scales 0-4 with 0 as no psoriasis and 4 is severe psoriasis|16 weeks||||units on a scale||Standard Deviation|Mean
2543218|NCT02983981|Primary|Psoriasis Severity|Physician's Global Assessment x Percentage of Body Surface Area (scale scores 0-400 where 0 is best psoriasis 400 is worst possible psoriasis) Body surface area calculated as 1 of patient's palm is 1%.|16 weeks||||units on a scale||Standard Deviation|Mean
2543219|NCT02983877|Secondary|Change in Adherence to Antihypertensives Based on the Electronic Monitoring Device (eCAP)|"Study participants will be given an eCAP device for one of their pill bottles, which will record time/date of bottle opening. eCAP will be used for the antihypertensive medication that the patient missed the most frequently in the past week (in the case of multiple antihypertensive medications missed the same proportion of times, the medication dosed most often will be chosen). A dose will be counted as taken if the bottle is opened within six hours of the prescribed time. We will calculate a percent of doses taken by dividing the number of times the bottle is opened by the number of times it should have been opened as per the prescription."|change from Baseline (Week 4) to V2 (week 12)||||percentage of medications missed||Standard Deviation|Mean
2543229|NCT02983604|Secondary|Randomized Phase 2 Dose Expansion: Clinical Benefit Rate|Clinical benefit rate (CBR) was defined as the proportion of participants who achieve CR, PR, or stable disease that lasts for > 24 weeks based on RECIST v. 1.1 study progression criteria.|Baseline up to 2 years|As the study was terminated prior to the Phase 2 portion of the study, no participants were enrolled in the Phase 2 portion of the study and data was not collected for this endpoint.||||||
2543244|NCT02982863|Secondary|Baseline Characteristics: History of Disease|Baseline characteristics of patients in each treatment group: history of disease and hospitalization.|Day 1|eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC|||Participants|||Count of Participants
2543220|NCT02983877|Secondary|Change in Adherence to Bipolar Medication Based on the Tablets Routine Questionnaire (TRQ)|"This self-report measure identifies non-adherence for the past 7 days (Scott & Pope, 2002a, 2002b), by measuring the percentage of days with missed doses of a given medication. Adherence was assessed for each evidence-based BD regularly scheduled maintenance medication (lithium, anticonvulsant, antipsychotic) prescribed for ≥ 3 months. For individuals who were on more than one medication, an average TRQ was calculated for all BD medications. According to our study team's recent work, the correlation between a single index drug and all BD drugs was 0.95 providing support for measuring one medication as proxy for medication adherence (M. Sajatovic et al., 2015). PRN medications were not included."|change from Screen (Week 0) to V2 (week 12)|Missing data for one participants (i.e. n= 37).|||percentage of days with missed doses||Standard Deviation|Mean
2543221|NCT02983877|Secondary|Change in Systolic Blood Pressure||change from Screen (Week 0) to V2 (week 12)||||mmHg||Standard Deviation|Mean
2543222|NCT02983877|Primary|Change in Adherence to Anithypertensives Based on Tablets Routine Questionnaire (TRQ)|This self-report measure identifies non-adherence for the past 7 days (Scott & Pope, 2002a, 2002b), by measuring the percentage of days with missed doses of a given medication. Adherence will be assessed for each regularly scheduled antihypertensive that has been prescribed for ≥ 3 months. For individuals who are on more than one medication, an average TRQ will be calculated for all antihypertensive medications. PRN medications will not be included.|change from Screen (Week 0) to V2 (week 12)|Baseline descriptives|||percentage of days with missed doses||Standard Deviation|Mean
2543223|NCT02983617|Secondary|Percentage of Participants Experiencing Any Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)||First dose date up to the last dose date plus 30 days (maximum: 105 weeks)|The Safety Analysis Set included all randomized or enrolled participants who received at least 1 dose of any study drug.|||percentage of participants|||Number
2543224|NCT02983617|Secondary|Overall Response Rate (ORR), as Assessed by the Investigator Using the Modified IWCLL 2008 Criteria at Week 25|ORR was assessed based on modified IWCLL 2008 criteria and was defined as percentage of participants achieving a CR, CRi, partial remission (PR; including nodular partial response [nPR]), and PR with lymphocytosis (PR-L). CR and CRi: meeting all the criteria that have been defined in Outcome measures 1, 2 and 3. PR: ≥ 2 of these: ≥ 50% decrease in lymphocytes, lymphadenopathy, size of liver, size of spleen, and 50% decrease in bone marrow infiltrates; and ≥ 1 of these: neutrophils > 1500/μL or ≥ 50% increase from Baseline, platelets ≥ 100,000/µL or ≥ 50% increase from Baseline, hemoglobin >11 g/dL or ≥ 50% increase from Baseline. PR-L: meeting PR criteria; however, a lymphocytosis related to treatment may be present. nPR: All criteria for a CR/CRi were fulfilled, but the bone marrow showed lymphoid nodules.|Week 25|Participants in the Full Analysis Set were analyzed.|||percentage of participants||90% Confidence Interval|Number
2543225|NCT02983617|Secondary|Rate of CR With Peripheral Minimal Residual Disease (CR/PB MRD) Negativity, as Assessed by the Investigator Using the Modified IWCLL 2008 Criteria at Week 25|Rate of CR/PB MRD at Week 25 was defined as the percentage of participants who achieved CR/CRi per modified IWCLL 2008 criteria and also achieved PB MRD negativity at Week 25. CR: meeting following criteria and no disease related symptoms: no lymphadenopathy > 1.5 cm/hepatomegaly/splenomegaly; lymphocytes < 4000/μL; bone marrow sample must be normocellular with 30% lymphocytes and no B-lymphoid nodules; platelets > 100,000/µL; hemoglobin > 11 g/dL; and neutrophils > 1500/µL. CRi: CR criteria (no lymphadenopathy > 1.5 cm/hepatomegaly/splenomegaly; lymphocytes < 4000/μL; bone marrow [hypocellular] with 30% lymphocytes and no B-lymphoid nodules), persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. MRD response was assessed with FACS and MRD negativity was defined as one CLL cell per 10,000 leukocytes [0.01%], ie,<10^-4 and participants were defined as MRD negative if their disease burden was below this threshold.|Week 25|Participants in the Full Analysis Set were analyzed.|||percentage of participants||90% Confidence Interval|Number
2543226|NCT02983617|Secondary|Rate of CR With Bone Marrow Minimal Residual Disease (CR/BM MRD) Negativity, as Assessed by the Investigator Using the Modified IWCLL 2008 Criteria at Week 25|Rate of CR/BM MRD at Week 25 was defined as percentage of participants who achieved CR/CRi per modified IWCLL 2008 criteria and also achieved BM MRD negativity at Week 25. CR: meeting following criteria and no disease related symptoms: no lymphadenopathy > 1.5 cm/hepatomegaly/splenomegaly; lymphocytes < 4000/μL; bone marrow sample must be normocellular with 30% lymphocytes and no B-lymphoid nodules; platelets > 100,000/µL; hemoglobin > 11 g/dL; and neutrophils > 1500/µL. CRi: CR criteria (no lymphadenopathy > 1.5 cm/hepatomegaly/splenomegaly; lymphocytes < 4000/μL; bone marrow [hypocellular] with 30% lymphocytes and no B-lymphoid nodules), persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. MRD response was assessed with four-color-flow cytometry (FACS) and MRD negativity was defined as one CLL cell per 10,000 leukocytes [0.01%], ie,<10^-4 and participants were defined as MRD negative if their disease burden was below this threshold.|Week 25|Participants in the Full Analysis Set were analyzed.|||percentage of participants||90% Confidence Interval|Number
2543227|NCT02983617|Primary|Rate of Complete Response/Complete Remission (CR), as Assessed by Investigator Using Modified International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria at Week 25|Rate of CR per modified IWCLL 2008 criteria at Week 25 was defined as the percentage of participants who achieved CR/complete remission with incomplete recovery of the bone marrow (CRi) at Week 25. CR: meeting following criteria and no disease related symptoms: no lymphadenopathy > 1.5 cm/hepatomegaly/splenomegaly; lymphocytes < 4000/μL; bone marrow sample must be normocellular with 30% lymphocytes and no B-lymphoid nodules; platelets > 100,000/µL; hemoglobin > 11 g/dL; and neutrophils > 1500/µL. CRi: CR criteria (no lymphadenopathy > 1.5 cm/hepatomegaly/splenomegaly; lymphocytes < 4000/μL; bone marrow [hypocellular] with 30% lymphocytes and no B-lymphoid nodules), persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity.|Week 25|The Full Analysis Set included all randomized or enrolled participants who received at least 1 dose of any study drug.|||percentage of participants||90% Confidence Interval|Number
2543228|NCT02983604|Secondary|Randomized Phase 2 Dose Expansion: Overall Survival|Overall survival was defined as the interval from date of randomization to date of death from any cause.|Baseline up to 2 years|As the study was terminated prior to the Phase 2 portion of the study, no participants were enrolled in the Phase 2 portion of the study and data was not collected for this endpoint.||||||
2543297|NCT02981342|Secondary|Stage 1: PK: Area Under the Curve (AUC) (AUC[Tau]) of LY3023414||Cycle 1 Day 1 through Cycle 4 Day 1 (28 Day Cycles)|Zero Participants Analyzed: AUC cannot be calculated due to insufficient data collected.||||||
2543230|NCT02983604|Secondary|Randomized Phase 2 Dose Expansion: Overall Response Rate|Overall response rate (ORR) was defined as the proportion of participants who achieve complete response (CR) or partial response (PR), based on Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 study progression criteria.|Baseline up to 2 years|As the study was terminated prior to the Phase 2 portion of the study, no participants were enrolled in the Phase 2 portion of the study and data was not collected for this endpoint.||||||
2543231|NCT02983604|Secondary|Randomized Phase 2 Dose Expansion: Overall Safety Profile as Assessed by the Percentage of Participants Experiencing Any Adverse Events (AEs), Grade 3 or 4 AEs, Treatment-Related AEs, or Abnormalities in Laboratory Tests or Electrocardiograms||Baseline up to 2 years|As the study was terminated prior to the Phase 2 portion of the study, no participants were enrolled in the Phase 2 portion of the study and data was not collected for this endpoint.||||||
2543232|NCT02983604|Secondary|Phase 1b Dose Escalation: PK Parameter: AUCtau of GS-5829|AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).|Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Day 15|Participants in the PK Analysis Set with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
2543233|NCT02983604|Secondary|Phase 1b Dose Escalation: Pharmacokinetic (PK) Parameter: Cmax of GS-5829|Cmax is defined as the maximum observed concentration of drug.|Predose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose on Days 1 and 15|The PK Analysis Set included all enrolled participants who received at least 1 dose of study drug and have at least 1 nonmissing postdose concentration value reported by the PK laboratory, excluding participants who received concomitant medications prohibited in this study. Only participants with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2543234|NCT02983604|Primary|Randomized Phase 2 Dose Expansion: Progression-Free Survival|Progression-Free Survival (PFS) was defined as the interval from date of randomization to the earlier of the first documented confirmed disease progression or death from any cause.|Baseline up to 2 years|As the study was terminated prior to the Phase 2 portion of the study, no participants were enrolled in the Phase 2 portion of the study and data was not collected for this endpoint.||||||
2543235|NCT02983604|Primary|Phase 1b Dose Escalation: Number of Participants Experiencing Dose Limiting Toxicities (DLTs) Through Day 28 at Each Dose Level of GS-5829|"A DLT was a toxicity as defined below:~Grade ≥ 4 neutropenia~Grade ≥ 3 neutropenia with fever~Grade ≥ 3 thrombocytopenia~Grade ≥ 2 bleeding (e.g., gastrointestinal, respiratory, epistaxis, purpura)~Grade ≥ 3 or higher non-hematologic toxicity, except:~Grade 3 nausea or emesis with maximum duration of 48 hours on adequate medical therapy~Grade 3 diarrhea which persists for < 72 hours in the absence of adequate medical therapy~Grade ≥ 2 non-hematologic treatment-emergent adverse event (TEAE) that in the opinion of the investigator is of potential clinical significance such that further dose escalation would expose participants to unacceptable risk~Treatment interruption of ≥ 7 days due to unresolved toxicity~Grade 3 or Grade 4 elevation in aspartate transaminase (AST) or alanine transaminase (ALT) associated with a Grade 2 elevation in bilirubin that is at least possibly related to study drug"|Baseline up to 28 days|The DLT Analysis Set included all participants in the Safety Analysis Set who completed all treatment and safety procedures through Day 28, inclusive, or experienced a DLT prior to Day 28, exclusive.|||Participants|||Count of Participants
2543236|NCT02983448|Secondary|Heart Rate Variability Measures|low frequency to high frequency ratio. This is a measure of sympathovagal balance. A lower value reflects a more favorable balance between sympathetic and parasympathetic (vagal) tone.|after 1 hour of stimulation|All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized. The comparison is between active and sham stimulation.|||ratio||Standard Deviation|Mean
2543237|NCT02983448|Primary|Echocardiographic Markers of Diastolic Dysfunction|Global longitudinal strain|after 1 hour of stimulation|All patients received both active and sham transcutaneous vagus nerve stimulation, with the order being randomized. The comparison is between active and sham stimulation.|||percent||Standard Deviation|Mean
2543238|NCT02983305|Secondary|Change in Gait Speed Compared to Baseline (Measured in Seconds)|"Gait speed will be measured using an inertial measurement unit attached to participants' shoes and will quantify the time taken to move from the beginning to end of a short mobility course.~Average of data from both feet with intervention."|Baseline and two to four weeks||||meters per second||Inter-Quartile Range|Median
2543239|NCT02983305|Primary|Change in the Planimetric Area of Goldmann Visual Field With the Use of Head-mounted Display Technology Compared to Baseline (Measured in Degrees Squared)|"Using computer software we will calculate the area of participants' Goldmann visual fields in order to obtain a summary quantitative measurement of the extent of peripheral vision.~Average of both eyes visual fields with intervention."|Baseline and two to four weeks||||degrees^2||Inter-Quartile Range|Median
2543240|NCT02982928|Primary|Intra- and Post-operative Serum Concentrations|To determine whether adequate serum concentration of acetaminophen is achieved.|15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; 8 Hours; and 12-Hours Post-IV acetaminophen administration||||µg.mL-1||Standard Deviation|Mean
2543241|NCT02982863|Secondary|Baseline Characteristics: Concomitant Medication|"Baseline characteristics of patients in each treatment group:~concomitant medication"|Day 1|eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC|||Participants|||Count of Participants
2543242|NCT02982863|Secondary|Baseline Characteristics: AF Risk Score|"Baseline characteristics of patients in each treatment group: Atrial Fibrillation (AF) risk score~CHADS2: Congestive heart failure, Hypertension, Age, Diabetes, Stroke(doubled). CHADS2 score range from 0-6, with higher scores indicating the higher risk~CHA2DS2VASc: Cardiac failure or dysfunction, Hypertension, Age 75 (doubled), Diabetes, Stroke (doubled) Vascular disease, Age 65-74 and Sex category (female) score. CHA2DS2VASc score range from 1-9, with higher scores indicating the higher risk.~HAS-BLED: Hypertension, Abnormal renal function, Abnormal hepatic function. HAS-BLED score range from 0-8, with higher scores indicating the higher risk."|Day 1|eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC.|||Participants|||Count of Participants
2543243|NCT02982863|Secondary|Baseline Characteristics: History of Hospitalization|Baseline characteristics: history of hospitalization|Day 1|eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC|||Participants|||Count of Participants
2554602|NCT02756689|Primary|Total Time From Admission to Delivery||From baseline to the time of delivery (baseline is from admission), up to 7 days||||hours||Standard Deviation|Mean
2543245|NCT02982863|Secondary|Baseline Characteristics: Speciality of Prescribers of OAC|"Baseline characteristics of patients in each treatment group: speciality of prescribers of OAC.~int.= internal; Med.= Medicine"|Day 1|eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC|||Participants|||Count of Participants
2543246|NCT02982863|Secondary|Baseline Characteristics: Year of Initiating Treatment|Baseline characteristics of patients in each treatment group: year of initiating treatment|Day 1|eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC|||Participants|||Count of Participants
2543247|NCT02982863|Secondary|Baseline Characteristics: Gender|Baseline characteristics of patients in each treatment group: gender|Day 1|eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC|||Participants|||Count of Participants
2543248|NCT02982863|Secondary|Baseline Characteristics: Age|Baseline characteristics of patients in each treatment group: age|1 day|eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC|||Years||Standard Deviation|Mean
2543249|NCT02982863|Primary|Number of Patients Prescribed OAC Drug Edoxaban by Dosage|Number of patients prescribed OAC drug edoxaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.|Day 1|eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC|||Participants|||Count of Participants
2543250|NCT02982863|Primary|Number of Patients Prescribed OAC Drug Apixaban by Dosage|Number of patients prescribed OAC drug Apixaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.|Day 1|eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC|||Participants|||Count of Participants
2543251|NCT02982863|Primary|Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage|Number of patients prescribed OAC drug rivaroxaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.|Day 1|eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC|||Participants|||Count of Participants
2543252|NCT02982863|Primary|Number of Patients Prescribed OAC Drug Warfarin by Dosage|Number of patients prescribed OAC drug Warfarin at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.|Day 1|eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC|||Participants|||Count of Participants
2543253|NCT02982863|Primary|Number of Patients Prescribed OAC Drug Dabigatran by Dosage|Number of patients prescribed OAC drug dabigatran at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.|Day 1|eligible patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC|||Participants|||Count of Participants
2543254|NCT02982863|Primary|Number of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF|Number of patients by each type of study-target OAC drug (dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban) prescribed as the first Oral Anticoagulants (OAC) with Non-valvular atrial fibrillation (NVAF)|Day 1|Patients prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC|||Participants|||Count of Participants
2543255|NCT02982720|Secondary|Assess Adverse Events, Serious Adverse Events and Serious Adverse Events Leading to Discontinuation of the Treatment (Death) of Combined Pembrolizumab and Sylatron Therapy.|the combination of Sylatron and pembrolizumab as assessed by CTCAE v4|36 months|No data was collected or analyzed for this objective due to the early termination of the study by the funder.||||||
2543256|NCT02982720|Secondary|Assess Objective Response Rate (ORR)|the sum of complete response (CR) + confirmed partial response (PR) and will be determined as per irRC.|36 months|No data was collected or analyzed for this objective due to the early termination of the study by the funder.||||||
2543257|NCT02982720|Secondary|Asses Overall Survival (OS) of Patients Receiving Pembrolizumab and Sylatron|Defined as time from start of the treatment till the patient's death from any cause (patient who are still alive at the end of the study will be censored).|36 months|No data was collected or analyzed for this objective due to the early termination of the study by the funder.||||||
2543258|NCT02982720|Secondary|Assess Progression Free Survival (PFS) of Patients Receiving Pembrolizumab and Sylatron|Defined as time from start of the treatment till the patient's disease progression or death from any cause (those for whom event of progression or death not observed will be censored).|36 months|No data was collected or analyzed for this objective due to the early termination of the study by the funder.||||||
2543259|NCT02982720|Primary|Asses Objective Response Rate (ORR) of All Patients Receiving Pembrolizumab and Sylatron Combination Therapy|Defined as the proportion of subjects who achieve the best response (CR and PR) determined by RECIST1.1|12 months|No data was collected or analyzed for this objective due to the early termination of the study by the funder.||||||
2543260|NCT02982239|Primary|Perceived Stress Scale (PSS)|"Change in Perceived Stress Scale (PSS) score at the end of the 10-week intervention.The PSS is comprised of 14 items intended to measure how unpredictable, uncontrollable, and overloaded individuals find their life circumstances.Participants rate items on a 5-point Likert scale, ranging from 0 - Never to 4 - Very often. Scores range from 0-56 higher scores indicate greater perceived stress."|Change from baseline to post intervention, around 10 weeks after baseline||||score on a scale||Standard Deviation|Mean
2543261|NCT02982239|Primary|Centers for Epidemiological Studies Depression Scale (CESD)|Change in Centers for Epidemiological Studies Depression Scale (CESD) score at the end of 10-week intervention. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.|Change from baseline to post intervention, around 10 weeks after baseline||||score on a scale||Standard Deviation|Mean
2543272|NCT02982187|Secondary|Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP|For each DPI to be tested, overall errors including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL following first instruction from the HCP were recorded by the HCP on the checklists provided. Percentage of participants making at least one overall error after the first instruction from the HCP were reported.|Day 1|Intent-to-Treat Population|||Percentage of participants|||Number
2554603|NCT02756637|Primary|Overall Survival|Number of participants who survived at 26 years are reported.|26 years||||participants|||Number
2543262|NCT02982239|Primary|Centers for Disease Control (CDC)l and Prevention Health-Related Quality of Life Scale (HRQOL)|Change in CDC Health-Related Quality of Life Scale (HRQOL) score at the end of 10-week intervention. Health-related quality of life (HRQOL) is an individual's or a group's perceived physical and mental health over time. Unhealthy days are an estimate of the overall number of days during the previous 30 days when the respondent felt that either his or her physical or mental health was not good. Healthy days are the positive complementary form of unhealthy days. Healthy days estimates the number of recent days when a person's physical and mental health was good (or better) and is calculated by subtracting the number of unhealthy days from 30 days.|Change from baseline to post intervention, around 10 weeks after baseline||||Days out of 30||Standard Deviation|Mean
2543263|NCT02982239|Primary|Insomnia Severity Index (ISI)|"Change Insomnia Severity Index (ISI) score at the end of 10-week intervention. The Insomnia Severity Index is a frequently-used questionnaire to measure insomnia symptoms. Total score categories:~0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)"|Change from baseline to post intervention, around 10 weeks after baseline||||scores on a scale||Standard Deviation|Mean
2543264|NCT02982239|Primary|Pittsburgh Sleep Quality Index ( PSQI)|Change in Pittsburgh Sleep Quality Index (PSQI) score at the end of the 10-week intervention. The PSQI global score has a possible range of 0-21 points. A total score of 5 or above indicates overall poor sleep quality.|Change from baseline to post-intervention, around 10 weeks after baseline||||units on a scale||Standard Deviation|Mean
2543265|NCT02982187|Secondary|Number of Participants With Treatment Preference Based on Responses to the Preference Questionnaire, Which Considered Overall Treatment Preference|Participants demonstrated the use of ELLIPTA, and depending on the substudy DISKUS plus HandiHaler or Turbuhaler plus Handihaler. At the end of Visit 1, participants completed specific versions of the inhaler PQ (PQ1, PQ2, PQ3 or PQ4) according to the questionnaire they were randomized to. Participants assessed the inhaler preference based on overall treatment preference. Participants checked the response from the choice of ELLIPTA, DISKUS + HandiHaler (sub-study 1), Turbuhaler + Handihaler (sub-study 2) and No Preference. Number of participants with treatment preference based on responses to the preference questionnaire were reported.|Day 1|Intent-to-Treat Population|||Participants|||Number
2543266|NCT02982187|Secondary|Number of Participants With Treatment Preference Based on Responses to the Preference Questionnaire, Which Considered the Number of Steps Required to Take the COPD Medication|Participants demonstrated the use of ELLIPTA, and depending on the substudy DISKUS plus HandiHaler or Turbuhaler plus Handihaler. At the end of Visit 1, participants completed specific versions of the inhaler PQ (PQ1, PQ2, PQ3 or PQ4) according to the questionnaire they were randomized to. Participants assessed the inhaler preference based on the number of steps needed to take the COPD medication. Participants checked the response from the choice of ELLIPTA, DISKUS + HandiHaler (sub-study 1), Turbuhaler + Handihaler (sub-study 2) and No Preference. Number of participants with treatment preference based on responses to the preference questionnaire were reported.|Day 1|Intent-to-Treat Population|||Participants|||Number
2543267|NCT02982187|Secondary|Time Taken to be Given Instruction by the HCP (up to 2 Times) on Use of the Inhaler and to Demonstrate Correct Inhaler Use (T2)|The time in minutes from when the HCP started to instruct participant for the correct use of DPI until correct use was demonstrated including maximum of two attempts only, was recorded. A participant who did not demonstrate correct use at the end of the time period was censored. Participants who demonstrated correct use after reading the PIL (T1) were included with a time of 0 for T2. The median time to demonstrate correct DPI use (minutes) is taken from the Kaplan-Meier analysis. If more than 50% of the data is censored then the median is not applicable. Participants who demonstrated correct use after reading the PIL are included with T2=0.|Day 1|Intent-to-Treat Population.|||Minutes||Full Range|Median
2543268|NCT02982187|Secondary|Time Taken to Read the PIL and Demonstrate Correct Inhaler Use (T1)|For each DPI being tested, the time taken from when participant started reading the PIL until when correct use was demonstrated with no need of instructions by HCP was reported. A participant who did not demonstrate correct use at the end of the time period was censored. The median time to demonstrate correct DPI use (minutes) is taken from the Kaplan-Meier analysis. If more than 50% of the data is censored therefore the median is not applicable.|Day 1|Intent-to-Treat Population..|||Minutes||Full Range|Median
2543269|NCT02982187|Secondary|The Median Time to Demonstrate Correct Inhaler Use (T1+T2)|For each DPI being tested, the total time taken from when participant started reading the PIL until when correct use was demonstrated (that is the time required to read PIL, and two attempts for correct use of DPI following instructions provided by the HCP ) was recorded. A participant who did not demonstrate correct use at the end of the time period was censored. The median time to demonstrate correct DPI use (minutes) is taken from the Kaplan-Meier analysis. If more than 50% of the data is censored therefore the median is not applicable.|Day 1|Intent-to-Treat Population.|||Minutes||Full Range|Median
2543270|NCT02982187|Secondary|Number of Participants With Instructions (0, 1 or 2 Times) From the HCP Which Are Needed to Demonstrate Correct Inhaler Use|In each sub-study, if the participant made error while demonstrating the use of the DPI after reading the PIL, the HCP demonstrated the correct usage instructions to the participant. The participant was then asked to demonstrate the DPI again. Any errors made were recorded by the HCP, and the same process was repeated one more time. In total, the HCP instructed the participants on the use of the DPI up to two times after which there were no assessment scheduled. Number of participants with instructions (0, 1 or 2) needed to demonstrate correct DPI use by the participants were reported.|Day 1|Intent-to-Treat Population|||Participants|||Number
2543271|NCT02982187|Secondary|Percentage of Participants Making at Least One Overall Error After the Second Instruction From the HCP|For each DPI to be tested, overall errors including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL following first, and second instruction from the HCP were recorded by the HCP on the checklists provided. Percentage of participants making at least one overall error after the second instruction from the HCP were reported. These statistics are only presented when the model has successfully converged.|Day 1|Intent-to-Treat Population|||Percentage of participants|||Number
2543284|NCT02981524|Secondary|Progression Free Survival (PFS)|Progression-free Survival (PFS) is defined as the number of days from cycle 1, day 1 of immunotherapy until first documented local progression or death due to any cause. PD is >20% increase in sum of diameters of target lesions as assessed using RECIST (version 1.1).|up to 1 year||||days||95% Confidence Interval|Median
2543273|NCT02982187|Secondary|Percentage of Participants Making at Least One Overall Error After Reading the PIL|Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. Overall error was defined as an error including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL. For each DPI to be tested, overall errors including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL were recorded by the HCP on the checklists provided. Percentage of participants making at least one overall error after reading the PIL were reported.|Day 1|Intent-to-Treat Population|||Percentage of participants|||Number
2543274|NCT02982187|Secondary|Percentage of Participants Making at Least One Critical Error After the Second Instruction From the HCP|Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. After reading the PIL for each DPI to be tested, participants demonstrated the DPI and errors made by the participants while using each DPI were recorded by the HCP on the checklists provided. If a participant made an error while demonstrating DPI use after first instruction from the HCP, then the HCP provided instructions again on the correct use of the inhaler. The participant then demonstrated the DPI for one last time, and the HCP recorded the critical errors made on the checklists. Participants making at least one critical error after the second instruction from the HCP were reported.|Day 1|Intent-to-Treat Population|||Percentage of participants|||Number
2543275|NCT02982187|Secondary|Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP|Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. After reading PIL for each DPI to be tested, participants demonstrated the DPI and errors made by the participants while using each DPI were recorded by the HCP on the checklists provided. If a participant made errors while demonstrating DPI, HCP provided instruction on the correct use of the DPI. The participant then repeated the demonstration of DPI use, and the HCP recorded the critical errors made on the checklists. Percentage of participants making at least one critical error after the first instruction from the HCP were reported.|Day 1|Intent-to-Treat Population|||Percentage of participants|||Number
2543276|NCT02982187|Primary|Percentage of Participants Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL)|Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. After reading the PIL for each DPI to be tested, participants demonstrated the DPI and critical errors made by the participants while using each DPI were recorded by the Healthcare Professional (HCP) on the checklists provided. Percentage of participants making at least one critical error after reading PIL were reported.|Day 1|Intent-to-Treat Population|||Percentage of participants|||Number
2543277|NCT02982018|Secondary|Percentage of Eyes With Subject Reported Symptoms Problems or Complaints|Symptoms, problems and complaints are subject reported and were collected for each subject eye at the 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data is reported as a binary outcome of yes if a subject experience a problem or complaint or no otherwise. Symptoms, problems and complaints include the following: Burning/Stinging, Itchiness/Scratchiness, Dryness, Lens Awareness, Grittiness/Foreign Body Sensation, Redness, Irritation/Discomfort, Cloudy/Blurry/Hazy, Variable Vision and Other The Percentage of subjects eyes with symptoms, problems or complaints was reported for each lens and time point.|Up to 12-Week Follow-up|All subjects that were dispensed at least one study lens.|||Percentage of eyes|Eyes||Number
2543278|NCT02982018|Secondary|Contact Lens Wearing Time|Contact lens wearing time (hours) was self-reported by each subject at the 2-, 4-, 8- and 12-week follow-ups. The average contact lens wearing time (hours) for each lens and time point was reported.|Up to 12-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Hours||Standard Deviation|Mean
2543279|NCT02982018|Primary|Percentage of Eyes With Grade 3 or Higher Slit Lamp Findings|Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 2-4-8- and 12-week follow-ups. A new response variable was derived by dichotomizing the data as follows: 1 if a Grade 3or higher SLF was observed and 0 otherwise. The Percentage of eyes with Grade 3 or higher SLFs was reported for each lens and time point.|Up to 12-Week Follow-up|All subjects that were dispensed at least one study lens.|||Percentage of eyes|Eyes||Number
2543280|NCT02982018|Primary|Distance Monocular logMAR Visual Acuity (VA)|Distance logMAR Visual Acuity was assessed for each subject and eye at 2-, 4- 8- and 12-weeks. The average logMAR visual acuity for each lens and time point was reported. Lower values of logMAR indicate better vision.|Up to 12-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||logMAR|Eyes|Standard Deviation|Mean
2543281|NCT02982018|Primary|Eyestrain Related to Glare|Eyestrain related to glare was assessed at the 2-, 4-, 8- and 12- week follow-up visits using an 11-item questionnaire. This questionnaire assesses patient-experience attributes of soft contact lenses. Derived eyestrain related to glare scores using Item Response Theory (IRT) follow a normal distribution with a mean of 50 and a standard deviation of 10. Scores in this study ranged from 30 to 70. Lower scores indicate better performance. This questionnaire is still under development and the data collected is considered exploratory.|Up to 12-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Units on a Scale||Standard Deviation|Mean
2543282|NCT02981524|Secondary|Duration of Response (DOR)|Number of weeks from the start date of PR or CR (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease or death is documented. Per RECIST 1.1, CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions.|1 year|There were no patients that had a CR or PR. Therefore, data could not be collected to assess this outcome measure.||||||
2543283|NCT02981524|Secondary|Overall Survival (OS)|OS is defined as the number of days from start of study treatment to time of death. Individuals will be censored at the date of the last study visit if no event occurs. The estimation method used was Kaplan-Meier.|Up to 1 year||||days||95% Confidence Interval|Median
2543286|NCT02981524|Primary|Objective Response Rate (ORR)|ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.|up to 1 year|Data to assess objective response was only collected from 14/17 participants. The remaining 3 patients were withdrawn from study therapy for early clinical progression and were not evaluable for this outcome measure.|||Participants|||Count of Participants
2543287|NCT02981342|Secondary|Stage 1: PK: Mean Single Dose Concentration of LY3023414 at 2h Post-dose|Mean single dose exposure was reported by plasma concentrations collected approximately 2 hours post-dose.|C1D1: 2h Post dose|All randomized participants who received at least one dose of 150mg LY3023414 and had evaluable PK samples.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2543288|NCT02981342|Secondary|Stage 1: PK: Steady State Trough Pre Dose Concentration of LY3023414|Mean steady state exposure was reported by trough pre-dose plasma concentrations.|C2D1: 0h, C3D1: 0h, C4D1: 0h|All randomized participants who received at least one dose of 150mg LY3023414 and had evaluable PK samples.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2543289|NCT02981342|Secondary|Stage 2: Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)|"The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 items covered by 1 of 3 dimensions:~Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent).~Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much)~Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much).~Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function/QOL or higher levels of symptom burden.~No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1."|Baseline, 6 Months|All randomized participants with baseline & post baseline value for the EORTC QLQ-C30 specified item.|||units on a scale||Standard Error|Least Squares Mean
2543290|NCT02981342|Secondary|Stage 2: Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)|"mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity. In addition to pain intensity (4 items), the mBPI-sf is designed for participants to record the presence of pain in general, pain relief, and pain interference with function (general activity, mood, ability to walk, ability to perform normal work, relations with others, sleep, and enjoyment of life). Responses for the mBPI-sf items are captured through the use of 11-point numeric rating scales anchored at 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). The mBPI-sf recall period is 24 hours, and typical completion time for this instrument is less than 5 minutes.~No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1."|Baseline, 6 Months|All randomized participants with baseline & post baseline value for the mBPI-sf specified item.|||score on a scale||Standard Error|Least Squares Mean
2543291|NCT02981342|Secondary|Stage 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA 19-9) Level|No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.|Baseline, 6 Months|All randomized participants with baseline and post baseline CA 19-9 measurement.|||U/mL||Standard Deviation|Mean
2543292|NCT02981342|Secondary|Stage 2: Overall Survival (OS)|"OS duration is measured from the date of randomization to the date of death from any cause. for participants who is not known to have died as of the data-inclusion cutoff date, OS was censored at the last known alive date.~No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1."|Baseline to Death from Any Cause (Up to 10 Months)|All randomized participants. Censored participants: Abemaciclib 200mg: 11, Abemaciclib 150mg + LY3023414 150mg: 12, Gemcitabine + Capecitabine: 21;|||Months||95% Confidence Interval|Median
2543293|NCT02981342|Secondary|Stage 2: Duration of Response (DoR)||Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 6 Months)|The population for analyzing DoR is the number of participants with response of CR or PR. There was only one participant in 200 mg Abemaciclib arm and one participant in Gemcitabine/Capecitabine arm. Due to small number of participants, the data is not analyzable using the planned time to event analysis.||||||
2543294|NCT02981342|Secondary|Stage 2: Clinical Benefit Rate (CBR): Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months|"Clinical benefit rate (CBR) is the percentage of participants with a BOR of CR or PR, or SD ≥6 months. CR is defined as the disappearance of all target and non-target lesions & no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.~No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1."|Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 6 Months)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2543295|NCT02981342|Secondary|Stage 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD||Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)|Data not reported, no patients were enrolled to stage 2.||||||
2543296|NCT02981342|Secondary|Stage 1: PK: Maximum Concentration (Cmax) at Steady State of LY3023414||Cycle 1 Day 1 through Cycle 4 Day 1 (28 Day Cycles)|Zero Participants Analyzed: Cmax cannot be calculated due to insufficient data collected.||||||
2554604|NCT02756624|Primary|Number of Treatment Related Adverse Events|Adverse events will be measured through study completion|up to 12 weeks|Intent to Treat (ITT)|||adverse events|||Number
2543298|NCT02981342|Secondary|Stage 1: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and Its Metabolites (LSN2839567 (M2), LSN3106726 (M20))|Mean steady state exposure was reported as measured by maximum observed plasma concentration (Cmax).|Cycle(C)1 Day(D)14: 0 hour(h),0.5h,1h,2h,4h,6h,8h post dose|All randomized participants who received at least one dose of Abemaciclib along with Galunisertib and had evaluable PK samples.|||Nanogram per Millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2543299|NCT02981342|Secondary|Stage 1: Objective Response Rate (ORR): Percentage of Participants With a Best Overall Response (BOR) of CR or PR|Objective response rate (ORR) is the percentage of participants with a BOR of CR or PR as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.|Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months)|All randomized participants.|||percentage of Participants||95% Confidence Interval|Number
2543300|NCT02981342|Primary|Stage 2: Progression Free Survival (PFS)|PFS was defined as the time from the date of randomization until first observation of objective progressive disease as defined by RECIST v1.1 or death from any cause, whichever comes first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a patient does not have a complete baseline disease assessment, then the PFS time will be censored at the randomization date, regardless of whether or not objectively determined disease progression or death has been observed for the patient; otherwise, if a patient is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time will be censored at the last complete objective progression-free disease assessment date.|Baseline to Measured Progressive Disease or Death Due to Any Cause (Up to 6 Months)|All randomized participants. Censored participants: Abemaciclib 200 mg: 3, Abemaciclib 150mg + LY3023414 150mg: 8, Gemcitabine & Capecitabine: 18; No participants were enrolled in stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled in stage 1.|||Months||95% Confidence Interval|Median
2543301|NCT02981342|Primary|Stage 1: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)|Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.|Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)|All randomized participants.|||percentage of Participants||95% Confidence Interval|Number
2543302|NCT02980978|Other Pre-specified|Aspirin Use (as Noted in EMR)|The count of participants represents taking aspirin as indicated at follow up|1 year||||Participants|||Count of Participants
2543303|NCT02980978|Other Pre-specified|Statin Use (as Noted in EMR)|The count of participants represents those taking a statin as indicated at follow up|1 year||||Participants|||Count of Participants
2543304|NCT02980978|Other Pre-specified|Tobacco Use (Self-reported Questionnaire)|The count of participants represents those not using tobacco at follow up|1 year||||Participants|||Count of Participants
2543305|NCT02980978|Other Pre-specified|Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings)|The count of participants represents the number of individuals meeting blood pressure less than 140/90 at follow up|1 year||||Participants|||Count of Participants
2543306|NCT02980978|Primary|A1c (Laboratory Assessment)|The count of participants represents the number of individuals meeting A1c less than 8% at follow up|1 year||||Participants|||Count of Participants
2543307|NCT02980783|Secondary|Mean Score for the Level of Naturalness of the Appearance of Participants' Dynamic Radial Cheek Lines as Assessed by a Participant Questionnaire|"Participants were asked to indicate their level agreement with the following statement: The treatment of my smile lines gave me a natural look. Responses were scored from 0 to 10, where 0=not at all to 10=very much."|Day 45|Per Protocol Population included all participants with no major protocol deviations.|||units on a scale||Standard Deviation|Mean
2543308|NCT02980783|Secondary|Percentage of Participants by Self-Perceived Age Category as Assessed by the Self-Perception of Age (SPA) Questionnaire|"The SPA questionnaire consists of one question: How do you think your facial appearance looks compared to your age TODAY? Participants could choose one of three possible answers: I look my current age, I look younger, or I look older. The percentage of participants in the following SPA categories is reported: I look my current age, I look younger and I look older."|Baseline (Day 1) to Day 45|Safety Population included all participants who used the test product at least one time. Number analyzed is the number of participants with available data at the given time-point.|||percentage of participants|||Number
2543309|NCT02980783|Secondary|Percentage of Participants by Improvement Rating (Response) of the Participants' Dynamic Radial Cheek Lines as Assessed by the Investigator Using the GAIS|The investigator graded the improvement of the participant's dynamic radial cheek lines on both sides of their face using the 5-point GAIS where -2=much worse to +2=much improved. Responders are participants with a score of +1 or +2 (improved or much improved, respectively) on both sides; partial responder are participants with a score of +1 or +2 on only one side; and no-responders are participants with a score lower or equal to 0 on both sides. The percentages of responders, partial responders, and no-responders are reported.|Baseline (Day 1) to Day 45|Per Protocol Population included all participants with no major protocol deviations.|||percentage of participants|||Number
2543310|NCT02980783|Secondary|Change From Baseline in Wrinkle Volume of Radial Cheek Lines at Maximum Smile||Baseline (Day 1) to Day 45|No data was collected because wrinkle volume was not applicable.||||||
2543311|NCT02980783|Secondary|Change From Baseline in Mean Amplitude (Rt) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®|The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers. A negative change from Baseline (pre-treatment) indicates that the amplitude of wrinkles decreased.|Baseline (Day 1) to Day 45|Safety Population included all participants who used the test product at least once. Number analyzed is the number of participants with available data at the given time-point.|||μm||Standard Deviation|Mean
2543312|NCT02980783|Secondary|Change From Baseline in Mean Texture (Rz) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®|The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers. A negative change from Baseline (pre-treatment) indicates that the texture of wrinkles improved.|Baseline (Day 1) to Day 45|Safety Population included all participants who used the test product at least once. Number analyzed is the number of participants with available data at the given time-point.|||μm||Standard Deviation|Mean
2543313|NCT02980783|Secondary|Change From Baseline in Mean Roughness (Ra) of the Radial Cheek Lines at Maximum Smile as Assessed by DERMATOP®|The DERMATOP® is a fringe projection system used to measure wrinkles. The system collects 2-dimensional (2D) and 3-dimensional (3D) images and then calculates the roughness, texture, and amplitude of wrinkles. To ensure that repeat measurements are made in the same area, the angles of the camera were recorded, and a red positioning laser was used to mark the edge of the chin. In addition, a 2D picture of the baseline measurements was taken by the machine to position subsequent measurements. Measurements are presented in micrometers (μm). A negative change from Baseline (pre-treatment) indicates that the roughness of wrinkles decreased.|Baseline (Day 1) to Day 45|Safety Population included all participants who used the test product at least one time. Number analyzed is the number of participants with available data at the given time-point.|||μm||Standard Deviation|Mean
2543314|NCT02980783|Primary|Percentage of Participants by Improvement Rating (Improved and Not Improved) of Their Dynamic Radial Cheek Lines as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS)|Participants graded the improvement of their dynamic radial cheek lines using the GAIS 5-point scale where -2=much worse to +2=much improved. Participants who rated their improvement as -2, -1, or 0 (much worse, worse, or no change, respectively) were grouped as Not Improved and those who rated their improvement as +1 or +2 (improved or much improved, respectively) were grouped as Improved. The percentages of participants who rated their cheek lines as Improved and Not Improved are reported.|Baseline (Day 1) to Day 45|Per Protocol Population included all participants with no major protocol deviations.|||percentage of participants|||Number
2543315|NCT02980601|Other Pre-specified|Patient Scar Assessment|Total score (20-200). Higher scores denote worse outcomes.|1 year||||score on a scale||Standard Deviation|Mean
2543316|NCT02980601|Other Pre-specified|Patient Scar Assessment|Total score (20-200). Higher scores denote worse outcomes.|6 month||||score on a scale||Standard Deviation|Mean
2543317|NCT02980601|Other Pre-specified|Patient Scar Assessment|Total score (20-200). Higher scores denote worse outcomes.|3 month||||score on a scale||Standard Deviation|Mean
2543318|NCT02980601|Primary|Skin Pliability|Skin pliability will be measuredusing a Cutometer MPA 580. We plan to measure Pliability (Ua), Elasticity (Ue), Retraction (Ur). Viscoelasticity (Uv), and Extension (Uf).|1 year|Data not collected||||||
2543319|NCT02980601|Primary|Percent of Wound Contracture|Planimetry Software will be used to measure and determine percentage of wound contracture|1 year|data not recorded||||||
2543320|NCT02980601|Primary|Percent of Wound Contracture|Planimetry Software will be used to measure and determine percentage of wound contracture|6 month|data not recorded||||||
2543321|NCT02980601|Primary|Percent of Wound Contracture|Planimetry Software will be used to measure and determine percentage of wound contracture|3 month|data not recorded||||||
2543322|NCT02980601|Primary|The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)|Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure|1 year|data not recorded for all subjects|||score on a scale||Standard Deviation|Mean
2543323|NCT02980601|Primary|The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)|Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure|6 month||||score on a scale||Standard Deviation|Mean
2543324|NCT02980601|Primary|The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)|Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure|3 month||||score on a scale||Standard Deviation|Mean
2543325|NCT02980601|Primary|The Disabilities of the Arm, Shoulder and Hand (QuickDASH) Questionnaire)|Functional outcome as measured by pre and post operative assessment on the QuickDASH scale. On a scale of 0-100; with higher score denotes worse outcome measure|pre-op|Data not collected||||||
2543326|NCT02980601|Primary|Patient Scar Assessment- Paresthesia|Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes|1 year|Data not collected||||||
2543327|NCT02980601|Primary|Patient Scar Assessment- Paresthesia|Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes|6 month|Data not collected||||||
2543328|NCT02980601|Primary|Patient Scar Assessment- Paresthesia|Presence of paresthesia on a 1-10 scale , higher score denote worse outcomes|3 month|Data not collected||||||
2543329|NCT02980601|Primary|Rate of Tendon Exposure|Tendon exposure identified clinically.|1 year|Data not collected||||||
2543330|NCT02980601|Primary|Number of Participant With Tendon Exposure|Tendon exposure identified clinically.|6 month||||participants|||Number
2543333|NCT02980601|Primary|Wrist Range of Motion- Extension|Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension|3 month||||degrees||Standard Deviation|Mean
2543334|NCT02980601|Primary|Wrist Range of Motion- Extension|Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension|pre-op||||degrees||Standard Deviation|Mean
2543335|NCT02980601|Primary|Wrist Range of Motion- Flexion|Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension|1 year|Data not collected||||||
2543336|NCT02980601|Primary|Wrist Range of Motion- Flexion|Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension|6 month||||degrees||Standard Deviation|Mean
2543337|NCT02980601|Primary|Wrist Range of Motion- Flexion|Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension|3 month||||degrees||Standard Deviation|Mean
2543338|NCT02980601|Primary|Wrist Range of Motion- Flexion|Functional outcomes will be measured by using electric goniometers so as to standardize the measurements. Wrist flexion and wrist extension|pre-op||||degrees||Standard Deviation|Mean
2543339|NCT02980601|Primary|Hand Strength- Pincer|Functional outcomes will be measured by using strength dynamometers|1 year|Data not collected||||||
2543340|NCT02980601|Primary|Hand Strength- Pincer|Functional outcomes will be measured by using strength dynamometers|6 month||||Lbs||Standard Deviation|Mean
2543341|NCT02980601|Primary|Hand Strength- Pincer|Functional outcomes will be measured by using strength dynamometers|3 month||||Lbs||Standard Deviation|Mean
2543342|NCT02980601|Primary|Hand Strength- Pincer|Functional outcomes will be measured by using strength dynamometers|pre-op||||Lbs||Standard Deviation|Mean
2543343|NCT02980601|Primary|Hand Strength - Grip|Functional outcomes will be measured by using strength dynamometers.|1 year|Data not collected||||||
2543344|NCT02980601|Primary|Hand Strength - Grip|Functional outcomes will be measured by using strength dynamometers.|6 month||||Lbs||Standard Deviation|Mean
2543345|NCT02980601|Primary|Hand Strength - Grip|Functional outcomes will be measured by using strength dynamometers.|3 month||||Lbs||Standard Deviation|Mean
2543346|NCT02980601|Primary|Hand Strength - Grip|Functional outcomes will be measured by using strength dynamometers.|pre-op||||Lbs||Standard Deviation|Mean
2543347|NCT02980601|Primary|Hand Strength -Lateral Pinch|Functional outcomes will be measured by using strength dynamometers.|1 year|Data not recorded.||||||
2543348|NCT02980601|Primary|Hand Strength -Lateral Pinch|Functional outcomes will be measured by using strength dynamometers.|6 months||||Lbs||Standard Deviation|Mean
2543349|NCT02980601|Primary|Hand Strength -Lateral Pinch|Functional outcomes will be measured by using strength dynamometers.|3 month||||Lbs||Standard Deviation|Mean
2543350|NCT02980601|Primary|Hand Strength -Lateral Pinch|Functional outcomes will be measured by using strength dynamometers.|Pre-op||||Lbs||Standard Deviation|Mean
2543351|NCT02980601|Primary|Vancouver Scar Scale - Height|Height will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome.|1 year|Data not collected||||||
2543352|NCT02980601|Primary|Vancouver Scar Scale - Pliability|Pliability will be measured on the Vancouver Scar Scale. On a scale of 1-5; higher score denoting worse outcome.|1 year|Data not collected||||||
2543353|NCT02980601|Primary|Vancouver Scar Scale - Vascularity|Vascularity will be measured on the Vancouver Scar Scale. On a scale of 0-3; higher score denoting worse outcome.|1 year|Data not collected||||||
2543354|NCT02980601|Primary|Vancouver Scar Scale - Pigmentation|Pigmentation will be measured on the Vancouver Scar Scale. On a scale of 0-2; higher score denoting worse outcome.|1 year|Data not collected||||||
2543355|NCT02980601|Primary|Vancouver Scar Scale|The Vancouver Scar Scale will measure donor site aesethetic quality and it encompasses 4 separate outcomes to be objectively assessed. Each has been separately reported in the literature for each group in different papers as previously mentioned. We will compare the final score as well as scores within each outcome.On a scale of 1-13; with higher score denoting worse outcome.|1 Year|Data not collected||||||
2543356|NCT02980601|Primary|Number of Participants With Skin Graft Necrosis.|Number of participants with skin graft necrosis.|1 year||||participants|||Number
2543357|NCT02980523|Secondary|Frequency of Corneal Epithelial Defects|"Corneal epithelial defects: qualitative ordinal variable, measurement scale present or absent.~The corneal epithelial defects was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group."|Up to one week|Treatment analysis|||Corneal defects cases reported|eyes||Number
2543358|NCT02980523|Secondary|Eyelid Edema Frequency|"Eyelid edema: qualitative ordinal variable, measurement scale absent or present.Between baseline (day 0) versus final visit (day 7).~The eyelid edema was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group."|Up to one week|Treatment analysis|||eyelid edema cases reported|eyes||Number
2543359|NCT02980523|Secondary|Chemosis Frequency|Chemosis: qualitative ordinal variable, measurement scale absent or present. The chemosis was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.|up to one week|Treatment analysis|||chemosis cases reported|eyes||Number
2543360|NCT02980523|Secondary|Number of Cases of Conjunctival Hyperemia|Conjunctival hyperemia: qualitative ordinal variable. The conjunctival hyperemia was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.|up to one week|Treatment analysis|||hyperemia cases reported|eyes||Number
2543361|NCT02980523|Secondary|Cases Frequency of Ocular Secretion|Secretion ocular: qualitative ordinal variable. The secretion was evaluated by subject of study as present / absent, taking into consideration that each study subject represents two probable cases, one for each eye. On this premise, the statistical analysis of the number of cases reported in the final visit was made by study group.|Up to one week.|treatment analysis.|||secretion cases reported|eyes||Number
2543362|NCT02980523|Primary|Adverse Events|Number of adverse events: dependent variable, discrete quantitative, the number of adverse events per group will be compared at the end of the study and it will be considered safe if there is not greater increase of 5% of serious adverse events.|during the intervention period for 7 days, and 15 days after the final visit|Treatment analysis|||events|eyes||Number
2543363|NCT02980523|Primary|Change From Baseline Bacterial Culture|"Efficacy will be determined comparing the cultures of the lower conjunctival pouch, of the baseline (day 1) against final visit (day 8), quantifying and identifying the colony forming units (CFU) by genus and species.~The evaluated variable is discrete quantitative type and the scale of measurement used will be CFU x mL considering the eradication, reduction or proliferation of the bacterial agent. It will be determined as effective if there is a reduction in number of bacterial flora in at least 95% of the evaluated subjects."|up to one week|Treatment analysis, a culture was performed per eye|||cultures|cultures||Number
2543364|NCT02980224|Secondary|The Frequency and Severity of Adverse Events|Number and Percentage of Subjects Reporting Adverse Events|84 Days|Safety Population|||Participants|||Count of Participants
2543365|NCT02980224|Primary|Change From Baseline in Dry Eye Symptom Scores (OSDI Questionnaire)|"Difference from Baseline (Day 1) to Day 84 in the OSDI Questionnaire (dry eye symptom score). Responses evaluate a subjects experience of a symptom on the following scale:~0 (none of the time)~(some of the time)~(half of the time)~(most of the time)~(all of the time)~The 12 questions are as follows:~Have you experienced any of the following during the last week:~Eyes that are sensitive to light~Eyes that feel gritty~Painful or sore eyes~Blurred vision~Poor vision~Have problems with your eyes limited you in performance of any of the following during the last week:~Reading~Driving at night~Working with a computer or bank machine (ATM)~Watching TV~Have your eyes felt uncomfortable in any of the following situations during the last week:~Windy conditions~Places or areas with low humidity (very dry)~Areas that are air conditioned~A higher score means a worse outcome. The scores for the 12 questions are added together."|Baseline and 84 Days|Intent to Treat Population|||score on a scale||Standard Error|Least Squares Mean
2543366|NCT02980224|Primary|Change From Baseline in Tear Break up Time(TBUT ) at Day 84|The difference between Baseline (Day 1) and Day 84 in Tear Break Up Time. TBUT is a clinical test used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film, as observed via slit lamp examination.|Baseline and 84 Days|Intent to Treat Population|||seconds||Standard Error|Least Squares Mean
2543367|NCT02980211|Primary|Bone Volumetric Reduction From Baseline to 20 Weeks Post-extraction|Alveolar bone volumetric reduction from baseline to 20 weeks using CBCT scans|Baseline and 20 weeks post-extraction|Two of the 17 DICOM datasets could not be analyzed due to extensive scattering, therefore the final sample size for this outcome was 15|||mm3||Standard Deviation|Mean
2543368|NCT02980133|Secondary|Percentage of Participants Who Discontinued From Investigational Medicinal Product (IMP) for Asthma Exacerbation During the 12 Week Treatment Period||Baseline up to Week 12|ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||percentage of participants|||Number
2543369|NCT02980133|Secondary|Time to First Onset of Effect|The time to first onset of effect, defined as the first decrease from baseline in daily rescue medication use, was calculated based on the number of inhalations of rescue medication (albuterol/salbutamol hydrofluoroalkane metered-dose inhaler [HFA MDI] [90 mcg ex actuator] or equivalent) recorded by the participant each morning and evening in the patient diary built into the handheld device.|Baseline up to Week 12|ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||days||95% Confidence Interval|Median
2543370|NCT02980133|Secondary|Change From Baseline in Asthma Control (Measured by Childhood Asthma Control Test [C-ACT] Score) Over the 12 Week Treatment Period|C-ACT was a simple, participant-completed tool used for the assessment of overall asthma control. The first 4 items of the test were completed by the participant, while the last 3 items were completed by the participant's parents/legal guardians/caregivers. A total sum score based upon responses to all items was calculated to provide an overall measure of asthma control. The derived C-ACT score ranging from 0 to 27. These scores spanned the continuum of poor control of asthma (score ≤5) to complete control of asthma (score ≥25), with a cut off score of 19 indicating participants with poorly controlled asthma. LS mean and SE were obtained using MMRM.|Baseline, Week 1 to 12|ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2543371|NCT02980133|Secondary|Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1 Through 12|Asthma symptom scores were recorded in the patient diary. Each participant assessed the symptoms of cough, wheeze, shortness of breath, and chest tightness and entered a single score that was inclusive of all symptoms. Daytime Symptom Score (determined in the evening) ranged from 0=No symptoms during the day to 5=Symptoms so severe that I could not go to work or perform normal daily activities. Nighttime Symptom Score (determined in the morning) ranged from 0=No symptoms during the night to 4=Symptoms so severe that I did not sleep at all. The total daily asthma symptom score was the average of the daytime and nighttime scores. The total daily asthma symptom score ranged from 0 - 9 with 0=no symptoms during the day or night and 9=severe symptoms both day and night. The weekly average was calculated as the sum of total daily asthma symptom scores over the 7 days for each analysis week divided by the number of nonmissing assessments. LS mean and SE were obtained using MMRM.|Baseline, Week 1 to 12|ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2543372|NCT02980133|Secondary|Change From Baseline in the Weekly Average of Total Daily (24 Hour) Use of Albuterol/Salbutamol Inhalation Aerosol (Number of Inhalations) Over Weeks 1 Through 12|Participants recorded the number of inhalations of rescue medication (albuterol/salbutamol HFA MDI) each morning and evening in the electronic patient diary. An entry of 0 inhalations indicated no rescue medication was needed. To calculate the total daily use of albuterol/salbutamol inhalation aerosol (number of inhalations), the electronic patient diary entry on randomization visit (Baseline [Day 1]) was defined as the first day of analysis. The weekly average of the total daily inhalations was the average based on the available data for that week. The average was calculated as the sum of total daily inhalations over the 7 days for each analysis week divided by the number of nonmissing assessments. LS mean and standard error (SE) were obtained using mixed model for repeated measures (MMRM).|Baseline, Week 1 to 12|ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||inhalations||Standard Error|Least Squares Mean
2543373|NCT02980133|Secondary|Change From Baseline in the Weekly Average of Daily Trough Morning (Predose and Pre-Rescue Bronchodilator) Peak Expiratory Flow (PEF) Over the 12 Week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Morning PEF was determined in the morning, before administration of IMP or rescue medications. Baseline trough morning PEF was defined as the average value of recorded (nonmissing) morning assessments 5 out of the last 7 days prior to randomization. The first day before randomization consisted of the electronic patient diary entry at home on the morning of the randomization visit (Baseline [Day 1]) and the first day postrandomization consisted of the electronic patient diary entry at home on the morning of the day after the randomization visit (Baseline [Day 1]). For postdose weekly average of trough morning PEF measurements, the values were the averages based on the available data for that week. The averages were calculated as the sum of morning PEF values divided by the number of nonmissing assessments.|Baseline, Week 1 to 12|ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||liters/minute||Standard Error|Least Squares Mean
2543374|NCT02980133|Primary|For Fp MDPI Versus Placebo: Change From Baseline in Weekly Average of the Percent Predicted Trough Morning FEV1 at Week 12|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Baseline trough morning percent predicted FEV1 was defined as the average value of recorded (nonmissing) morning assessments 5 out of the last 7 days prior to randomization. The first day before randomization consisted of the electronic patient diary entry at home on the morning of the randomization visit (Baseline [Day 1]) and the first day postrandomization consisted of the electronic patient diary entry at home on the morning of the day after the randomization visit (Baseline [Day 1]). For postdose weekly average of trough morning percent predicted FEV1 measurements, the values were the averages based on the available data for that week. The averages were calculated as the sum of morning FEV1 values divided by the number of nonmissing assessments.|Baseline, Week 12|ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. Missing data was imputed using missing not at random (MNAR) methodology for prematurely discontinue participants or missing at random (MAR) for completers with implausible data.|||percent predicted of FEV1||Standard Error|Least Squares Mean
2543375|NCT02980133|Primary|For FS MDPI Versus Fp MDPI: Change From Baseline in 1-Hour Postdose Percent Predicted Morning Forced Expiratory Volume in 1 Second (FEV1) at Week 12|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. The baseline 1-hour trough morning percent predicted FEV1 was defined as the predose trough morning percent predicted FEV1 measurement at the randomization visit (Baseline [Day 1]) at the investigational center. The IMP dose was administered right after the predose FEV1 measurement (within a 10 minute window). Participant then performed 1-hour (±10 minutes) postdose lung function assessments on Week 12 at the investigational center.|Baseline, Week 12|ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. Missing data was imputed using MNAR methodology for prematurely discontinue participants or MAR for completers with implausible data.|||percent predicted of FEV1||Standard Error|Least Squares Mean
2543376|NCT02980107|Other Pre-specified|Health Numeracy|This section will use 6-item General health numeracy test (Osborne et al., 2013) in order to determine how much our participants understand the basic health instructions regarding numeracy dimension. For each correct answer, the participants receive one point and the total score is the sum of all correct answers.|One month (30 days)||||units on a scale||Inter-Quartile Range|Median
2543377|NCT02980107|Secondary|User Friendliness|This section of the survey will have 5 questions concerning how easy it was for the participant to find relevant information, measured by a 10-point Likert type scale where the answer 1 means I do not agree at all and 10 means I fully agree. The total score is the sum of scores on all the answers (minimum 5, maximum 50). Higher scores indicate greater perception of the summary format as more user friendly.|One month (30 days)||||units on a scale||95% Confidence Interval|Median
2543378|NCT02980107|Secondary|Reading Experience|This section of the survey will include 5 questions about the experience of participants about the text they read, measured on a 10-point Likert type scale, where 1 means do not agree at all and 10 means fully agree. The total score is the sum of scores on all five answers (minimum 5, maximum 50). Greater scores indicate more positive reading experience.|One month (30 days)||||units on a scale||95% Confidence Interval|Median
2543379|NCT02980107|Primary|Understanding of the Summary Content|The questions will focus on understanding the benefits and risks of the intervention and the quality of evidence described in the systematic review. There will be 10 open ended questions, which will be assessed by two assessors, and the total score will be the sum of correct answers (total score ranging from 0-10). Higher scores would represent greater understanding of the content.|One month (30 days)||||units on a scale||95% Confidence Interval|Median
2543380|NCT02980042|Secondary|Changes in Treatment Efficiency (T Cell)|We will measure T cell depletion before each ocrelizumab infusion (T0, T1 and T2), by the clinical laboratories at the University of Colorado Hospital.|Prior to Day 1 infusion, 6 month infusions, and 12 month research termination visit|||||||
2543767|NCT02970552|Secondary|Preliminary Efficacy|Number of participants delivering before 34 and 37 completed weeks of gestation, grouped based on whether the participant went into labor spontaneously or was induced by a provider|Visit 10.0 (Delivery)||||Participants|||Count of Participants
2543381|NCT02980042|Secondary|Changes in Patient Reported Infusion Tolerance|A short patient reported outcome Likert scale describing the patient's experience to any IRR will be developed by the research team at RMMSC. This scale will be administered by the study coordinators at the end of each infusion. Scale items will measure patient responses to their perception and experience of IRRs.|At the end of Day 1 infusion, day 15 and 6 month infusions|||||||
2543382|NCT02980042|Secondary|Changes in Cytokine Profile|To better characterize infusion reactions and evaluate the contribution by either hypersensitivity reactions to ocrelizumab directly and/or by release of cytokines from dyeing CD20 positive cells, serum levels of cytokines will be evaluated. Cytokines will be measured using the MesoScale platform before and 4 hours after the start of each ocrelizumab infusion (T0,T1,T2,T3). Plasma samples will be analyzed using the V-PLEX Human Biomarker 40-Plex Kit.|Prior to and 4 hours after Day 1 infusion, day 15 infusion, 6 month infusion, 12 month research termination visit|||||||
2543383|NCT02980042|Secondary|Changes in Treatment Efficiency (B Cell)|We will measure B cell depletion before each ocrelizumab infusion (T0, T1 and T2), by the clinical laboratories at the University of Colorado Hospital. We will measure the proportion of patients who are B cell depleted (CD-19+ and CD-20+) by the time of the next infusion and 6 months after the last infusion in the switching group.|Prior to Day 1 infusion, 6 month infusions, and 12 month research termination visit|||||||
2543384|NCT02980042|Secondary|Treatment Induced Anti-Drug Antibodies|We will measure the number of patients who have treatment induced ADAs against rituximab and ocrelizumab prior to every ocrelizumab infusion (T0, T1, T2) and at the research termination visit (T3). This analysis will be performed by PPD Laboratories and Covance as a single batch at end of study for the switching group.|Prior to Day 1 infusion, day 15 and 6 month infusions|||||||
2543385|NCT02980042|Primary|Proportion of Patients With an IRR at Day 1 Versus Day 15 and Week 24 Infusions|We will also compare the proportion of patients with an IRR following day 1 infusion versus the proportion of patients with an IRR at day 15 and month 6 infusions of ocrelizumab in the switching group.|Day 1, Day 15, Week 24||||Participants|||Count of Participants
2543386|NCT02980042|Primary|Severity of IRRs Following the Week 24 Infusion of Ocrelizumab in the Switching and the Comparator Groups Infusions|The severity of IRRs will be assessed following each infusion of ocrelizumab in the switching and comparator group using the National Cancer Institute's Common Terminology for Adverse Events Scale (Grades range from 1-5, with higher Grades indicating more severe reactions). The frequency of each severity grade of IRR will be compared in a similar fashion .|Week 24, pre-study infusions|The Switching group received 3 infusions (Day 1, Day 15 and week 24), and the Comparator group received 2 infusions. Proportion of IRRs are taken out of total number of infusions. This analysis is comparing IRRs of the Switching group's Week 24 infusion, with the comparator group's pre-study infusion 1 and 2.|||Infusions|Infusions||Number
2543387|NCT02980042|Primary|Severity of IRRs Following the Day 15 Infusion of Ocrelizumab in the Switching and the Comparator Groups Infusions|The severity of IRRs will be assessed following each infusion of ocrelizumab in the switching and comparator group using the National Cancer Institute's Common Terminology for Adverse Events Scale (Grades range from 1-5, with higher Grades indicating more severe reactions). The frequency of each severity grade of IRR will be compared in a similar fashion.|Day 15, pre-study infusions|The Switching group received 3 infusions (Day 1, Day 15 and week 24), and the Comparator group received 2 infusions. Proportion of IRRs are taken out of total number of infusions. This analysis is comparing IRRs of the Switching group's Day 15 infusion, with the comparator group's pre-study infusion 1 and 2.|||Infusions|Infusions||Number
2543388|NCT02980042|Primary|Severity of IRRs Following the Day 1 Infusion of Ocrelizumab in the Switching and the Comparator Groups Infusions|The severity of IRRs will be assessed following each infusion of ocrelizumab in the switching and comparator group using the National Cancer Institute's Common Terminology for Adverse Events Scale (Grades range from 1-5, with higher Grades indicating more severe reactions). The frequency of each severity grade of IRR will be compared in a similar fashion .|Day 1, pre-study infusions|The Switching group received 3 infusions (Day 1, Day 15 and week 24), and the Comparator group received 2 infusions prior to enrollment (as assessed via retrospective chart review). This analysis is comparing IRRs of the Switching group's Day 1 infusion, with the comparator group's pre-study infusion 1 and 2.|||Infusions|Infusions||Number
2543389|NCT02980042|Primary|Difference in the Total Number of IRRs After Each Infusion of Ocrelizumab Compared to Rituximab Infusions in the Comparator Group.|The investigators will report the difference in the total number of IRRs after each infusion of ocrelizumab compared to combined rituximab infusions in the comparator group.|Pre-study (Enrollment), Day 1, Day 15, Week 24|Participants in the comparator group were assessed to have had two pre-study infusions at time of enrollment. A retrospective chart review was conducted to determine the number of IRRs experienced during these previous infusions. The collected number of IRRs was used as a comparison measure against the switching group.|||Infusions|Infusions||Number
2543390|NCT02980042|Primary|Proportion of Infusions With >= 1 IRR Between the Switching and Comparator Groups|The investigators will report the proportion of infusions with >= 1 IRR (infusion-related reaction) between the switching and comparator groups. Data was collected at Day 1, Day 15, and Week 24 and combined to determine the overall proportion of IRRs over the life of the study.|Day 1, Day 15, Week 24|The Switching group received 3 infusions (Day 1, Day 15 and week 24), and the Comparator group received 2 infusions. There were a total of 300 infusions in the Switching group and 200 in the Comparator group. Proportion of IRRs are taken out of total number of infusions.|||percentage of infusions with IRRs|Infusions||Number
2543391|NCT02979639|Secondary|Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs)|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From Day 1 to study end at Month 14|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Participants|||Count of Participants
2543392|NCT02979639|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs) During the Entire Study Period|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.|From Day 1 to study end at Month 14|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Participants|||Count of Participants
2543393|NCT02979639|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|"An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.~Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination."|During a 30-day follow-up period (Day 1 to Day 30) after any vaccination (across doses).|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Participants|||Count of Participants
2543394|NCT02979639|Secondary|Number of Days With Solicited General Symptoms After Second Dose|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)].|During a 7-day follow-up period (Day 1 to Day 7) after second dose.|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Days||Inter-Quartile Range|Median
2543395|NCT02979639|Secondary|Number of Days With Solicited General Symptoms After First Dose|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)].|During a 7-day follow-up period (Day 1 to Day 7) after first dose.|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Days||Inter-Quartile Range|Median
2543396|NCT02979639|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Second Dose|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary, tympanic temperature ≥ 37.5 °C]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature≥39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During a 7-day follow-up period (Day 1 to Day 7) after second dose.|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Participants|||Count of Participants
2543397|NCT02979639|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After First Dose|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and temperature [defined as oral, axillary or tympanic temperature equal to or above (≥)37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal everyday activities. Grade 3 temperature=temperature≥39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During a 7-day follow-up period (Day 1 to Day 7) after first dose.|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Participants|||Count of Participants
2543398|NCT02979639|Secondary|Number of Days With Solicited Local Symptoms After Second Dose|Assessed solicited local symptoms were pain, erythema and swelling.|During a 7-day follow-up period (Day 1 to Day 7) after second dose.|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Days||Inter-Quartile Range|Median
2543399|NCT02979639|Secondary|Number of Days With Solicited Local Symptoms After First Dose|Assessed solicited local symptoms were pain, erythema and swelling.|During a 7-day follow-up period (Day 1 to Day 7) after first dose.|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Days||Inter-Quartile Range|Median
2543400|NCT02979639|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Second Dose|Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 erythema/swelling=erythema/swelling spreading beyond 100 millimeters (mm) of injection site.|During a 7-day follow-up period (Day 1 to Day 7) after second dose.|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Participants|||Count of Participants
2543401|NCT02979639|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms After First Dose|Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 erythema/swelling =erythema/swelling spreading beyond 100 millimeters (mm) of injection site.|During a 7-day follow-up period (Day 1 to Day 7) after first dose.|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Participants|||Count of Participants
2543402|NCT02979639|Secondary|Days of Extra Work for Dedicated Caregivers After Second Dose|Descriptive analysis. Estimation of extra work for dedicated caregivers, expressed in days. Data was not reported for this outcome measure as there was no extra work for the dedicated caregivers|From Day 1 to Day 7 after second dose|The analysis was performed on the total number of dedicated caregivers who reported extra work after second dose and were part of the exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.||||||
2543403|NCT02979639|Secondary|Days of Extra Work for Dedicated Caregivers After First Dose|Descriptive analysis. Estimation of extra work for dedicated caregivers. Data was not reported for this outcome measure as there was no extra work for the dedicated caregivers|From Day 1 to Day 7 after first dose|The analysis was performed on the total number of dedicated caregivers who reported extra work after the first dose and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered.||||||
2543404|NCT02979639|Secondary|Days of Work Loss for Non-dedicated Caregivers After Second Dose|Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for non-dedicated caregivers, expressed in days. Data was not reported for this outcome measure as there was no work loss among the non-dedicated caregivers|From Day 1 to Day 7 after second dose|The analysis was performed on the total number of non-dedicated caregivers who reported work loss after second dose and were a part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered.||||||
2543405|NCT02979639|Secondary|Days of Work Loss for Non-dedicated Caregivers After First Dose|Descriptive analysis. Estimation of work loss of non-dedicated caregivers expressed in days.Data was not reported for this outcome measure as there was no work loss among the non-dedicated caregivers|From Day 1 to Day 7 after first dose|The analysis was performed on the total number of non-dedicated caregivers who reported work loss after the first dose and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered||||||
2543406|NCT02979639|Secondary|Days of Work Loss for Subjects After Second Dose|Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for subjects, expressed in days.|From Day 1 to Day 7 after second dose|The analysis was performed on the total number of subjects who reported work loss after the second dose and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered|||Days||Standard Deviation|Mean
2543407|NCT02979639|Secondary|Days of Work Loss for Subjects After First Dose|Descriptive analysis. Estimation of work loss due to any reaction related to the study vaccine for subjects, expressed in days.|From Day 1 to Day 7 after first dose|The analysis was performed on the total number of subjects who reported work loss after the first vaccination and were part of the exposed set, which included all vaccinated subjects with respect to the vaccine actually administered|||Days||Standard Deviation|Mean
2543408|NCT02979639|Secondary|Number of Reactogenicity-triggered Medically Attended Visits After Second Dose|Medical attention and health resource utilization triggered by frequency of reactogenicity events. Healthcare resources included staff involved in the following activities: telephone calls, visit to general practitioner, visit to specialist, visit to emergency room and hospitalizations.|From Day 1 to Day 7 after second dose|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Visits|||Number
2543409|NCT02979639|Secondary|Number of Reactogenicity-triggered Medically Attended Visits After First Dose|Medical attention and health resource utilization triggered by frequency of reactogenicity events. Healthcare resources included staff involved in the following activities: telephone calls, visit to general practitioner, visit to specialist, visit to emergency room and hospitalizations.|From Day 1 to Day 7 after first dose|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Visits|||Number
2543410|NCT02979639|Secondary|Change in QALY After Second Dose|Descriptive analysis. QALY estimation is done from baseline score, based on EQ-5D questionnaires. Baseline versus combined score over the period Day 2 to Day 8 after each vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 and EQ-5D questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The EQ-5D is a generic measure of health status that provides a simple description profile based on 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles (e.g. 1-no problem/no symptom) and profiles are subsequently converted to a continuous single index utility score (higher scores represent a better quality of life).|From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Score units||Standard Deviation|Mean
2543411|NCT02979639|Secondary|Change in Quality-adjusted Life Year (QALY) After First Dose|Descriptive analysis. QALY estimation is done from baseline score, based on EQ-5D questionnaires. Baseline versus combined score over the period Day 2 to Day 8 after each vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of EQ-5D questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The EQ-5D is a generic measure of health status that provides a simple description profile based on 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, which are used to generate the EQ-5D index utility score. The EQ-5D index utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome.|From Baseline at Day -7 to Day 8 after first dose|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Score units||Standard Deviation|Mean
2543412|NCT02979639|Secondary|Change in SF-36 Role Physical Scores After Second Dose|Descriptive analysis. SF-36 Role Physical scores change was measured from baseline score. Changes in the score were measured as Baseline versus Day 8 score after the second vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.|From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Score units||Standard Deviation|Mean
2543413|NCT02979639|Secondary|Change in SF-36 Role Physical Scores After First Dose|Descriptive analysis. SF-36 Role physical scores change was measured from baseline score. Baseline versus mean score on Day 8 after first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.|From Baseline at Day -7 to Day 8 after first dose|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Score units||Standard Deviation|Mean
2543480|NCT02979262|Primary|Change in Total Score of the Difficulties With Emotion Regulation Scale (DERS)|Emotion regulation difficulties are measured using this standardized self-report measure and a total score is calculated by summing the items. Score range is 0 to 180 with higher scores meaning worse outcome. Change over time is reported as the slope.|Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28||||ratio score baseline to 28 weeks||Standard Error|Mean
2543414|NCT02979639|Secondary|Change in Mean SF-36 PF Single Item Scores After Second Dose|Descriptive analysis of the change in mean SF-36 PF single item score from baseline. Baseline versus mean score over the period Day 2 to Day 8 after each vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (equivalent to Day 1 for dose 2) The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. Among items are vigorous activities (running, lifting heavy objects, participating in strenuous sports), moderate activities (moving a table, pushing a vaccum cleaner, bowling, or playing golf) and others, described in the categories below.|From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Score units||Standard Deviation|Mean
2543415|NCT02979639|Secondary|Change in Mean SF-36 PF Single Item Scores After First Dose|Descriptive analysis of the change in mean SF-36 PF single item score from baseline. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after the first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were Days 2 to 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning. Among items are vigorous activities (running, lifting heavy objects, participating in strenuous sports), moderate activities (moving a table, pushing a vaccum cleaner, bowling, or playing golf) and others, described in the categories below.|From Baseline at Day -7 to Day 8 after first dose|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Score units||Standard Deviation|Mean
2543416|NCT02979639|Secondary|Change in Mean SF-36 PF Scale Scores From Baseline Score to Mean Score After Second Dose|Descriptive analysis of the mean and standard deviation of the change from baseline of the SF-36 PF scale score pre and post dose 2 overall. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after second vaccination. For dose 2 baseline is defined as the mean of the three assessments at Day -7, Day 1 and Day 61 (Day 1 for dose 2). The post-vaccination completion of SF-36 questionnaires brought home by the subjects were on Day 2 to Day 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.|From Day -7 to first dose until Day 8 after second dose (equivalent to study Days -7 to 68)|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Score units||Standard Deviation|Mean
2543417|NCT02979639|Primary|Change in the Short Form 36-item-health Survey (SF36) Physical Functioning (PF) From Baseline Score to Mean Score After First Dose|Descriptive analysis of the mean and standard deviation (SD) of the change from baseline of the SF-36 physical functioning (PF) score pre- and post dose 1 overall. Changes in the score were measured as Baseline versus mean score over the period Day 2 to Day 8 after first vaccination. Baseline for dose 1 is defined as the mean of the assessments at Day -7 and Day 1. The post-vaccination completion of SF-36 questionnaires brought home by the subjects were Days 2 to 7, with Day 8 to be filled in at the site. The SF-36 scale scores are constructed following the summated ratings of the questions and standardized SF-36 scoring algorithm. Scores range from 0 to 100, with a higher score representing a higher level of functioning.|From Baseline at Day -7 to Day 8 after first dose|The analysis was performed on the Exposed Set, which included all vaccinated subjects with respect to the vaccine actually administered.|||Score units||Standard Deviation|Mean
2543418|NCT02979613|Secondary|Change From Baseline in eGFR-CG at Week 96||Baseline; Week 96|||||||
2543419|NCT02979613|Secondary|Change From Baseline in eGFR-CG at Week 48|"Cockcroft-Gault formula is as follows:~For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)~For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)~Change from baseline was calculated as the value at Week 48 minus the value at Baseline."|Baseline; Week 48|Participant in the Safety Analysis Set (all randomized participants who received at least 1 dose of study drug) with available data were analyzed. Participants were analyzed according to the treatment they actually received.|||mL/min||Standard Deviation|Mean
2543420|NCT02979613|Secondary|Percent Change From Baseline in Spine BMD at Week 96||Baseline; Week 96|||||||
2543421|NCT02979613|Secondary|Percent Change From Baseline in Spine BMD at Week 48|Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.|Baseline; Week 48|Participant in the Spine DXA Analysis Set (all participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline spine BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received.|||percent change||Standard Deviation|Mean
2543422|NCT02979613|Secondary|Percent Change From Baseline in Hip BMD at Week 96||Baseline; Week 96|||||||
2543423|NCT02979613|Secondary|Percent Change From Baseline in Hip BMD at Week 48|Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.|Baseline; Week 48|Participant in the Hip DXA Analysis Set (all participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline hip BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received.|||percent change||Standard Deviation|Mean
2543424|NCT02979613|Secondary|Change From Baseline in FibroTest Score at Week 96||Baseline; Week 96|||||||
2543425|NCT02979613|Secondary|Change From Baseline in FibroTest Score at Week 48|The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 48 minus the value at Baseline.|Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed. Participants were analyzed according to the treatment to which they were randomized.|||scores on a scale||Standard Deviation|Mean
2543426|NCT02979613|Secondary|Percentage of Participants With Normalized ALT at Week 96 (by Central Laboratory and AASLD Criteria)||Week 96|||||||
2543428|NCT02979613|Secondary|Percentage of Participants With Normalized ALT at Week 48 (by Central Laboratory and AASLD Criteria)|ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males.|Week 48|Participants in the Full Analysis Set with Baseline ALT > ULN were analyzed. Participants were analyzed according to the treatment to which they were randomized.|||percentage of participants|||Number
2543429|NCT02979613|Secondary|Percentage of Participants With Normal ALT at Week 48 (by Central Laboratory and the AASLD Criteria)|Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males.|Week 48|Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.|||percentage of participants|||Number
2543430|NCT02979613|Secondary|Percentage of Participants With HBsAg Seroconversion at Week 96||Week 96|||||||
2543431|NCT02979613|Secondary|Percentage of Participants With HBsAg Loss at Week 96||Week 96|||||||
2543432|NCT02979613|Secondary|Percentage of Participants With HBsAg Seroconversion at Week 48|HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.|Week 48|Participants in the Serologically Evaluable Full Analysis Set for HBsAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.|||percentage of participants|||Number
2543433|NCT02979613|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48|HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis.|Week 48|The Serologically Evaluable Full Analysis Set for HBsAg loss and seroconversion included all participants who were randomized and received at least 1 dose of study drug and were HBsAg-positive and HBsAb-negative or had a missing value at baseline. Participants were analyzed according to the treatment to which they were randomized.|||percentage of participants|||Number
2543434|NCT02979613|Secondary|Percentage of Participants With HBeAg Seroconversion at Week 96||Week 96|||||||
2543435|NCT02979613|Secondary|Percentage of Participants With HBeAg Loss at Week 96||Week 96|||||||
2543436|NCT02979613|Secondary|Percentage of Participants With HBeAg Seroconversion at Week 48|HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.|Week 48|Participants in the Serologically Evaluable Full Analysis Set for HBeAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.|||percentage of participants|||Number
2543437|NCT02979613|Secondary|Percentage of Participants With HBeAg Loss at Week 48|HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis.|Week 48|The Serologically Evaluable Full Analysis Set for HBeAg loss and seroconversion included all participants who were randomized and received at least 1 dose of study drug and were HBeAg-positive and HBeAb-negative or had a missing value at baseline. Participants were analyzed according to the treatment to which they were randomized.|||percentage of participants|||Number
2543438|NCT02979613|Secondary|Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 96||Week 96|||||||
2543439|NCT02979613|Secondary|Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 96||Week 96|||||||
2543440|NCT02979613|Secondary|Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 48|The method of determining percentage of participants with HBV DNA levels < 20 IU/mL (target detected/not detected that is lower limit of detection) at Week 48, as determined by the M = F approach.|Week 48|Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.|||percentage of participants|||Number
2543441|NCT02979613|Secondary|Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 48|The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was determined by the Missing = Failure (M = F) approach.|Weeks 48|Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.|||percentage of participants|||Number
2543442|NCT02979613|Secondary|Percentage of Participants With HBV DNA Levels ≥ 20 IU/mL at Week 96, as Determined by the Modified US FDA-Defined Snapshot Algorithm||Week 96|||||||
2543443|NCT02979613|Primary|Percentage of Participants With HBV DNA Levels ≥ 20 IU/mL at Week 48, as Determined by the Modified United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm|"The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:~Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 48 analysis window (from Day 295 to Day 378, inclusive), or~Did not have on-treatment HBV DNA data available in the Week 48 analysis window and~Discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or~Discontinued study drug prior to or in the Week 48 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL"|Week 48|The Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they were randomized.|||percentage of participants|||Number
2543502|NCT02978339|Secondary|Change in Fatigue Severity|Fatigue will be measured by a Modified Fatigue Impact Scale (MFIS). This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The full-length MFIS consists of 21 items. Subjects rate on a 5-point scale with 0 = never to 4 = almost always. The total score for the MFIS is the sum of the scores for the 21 items ranging from score of 0-84. Higher numbers indicate greater fatigue.|Baseline, 12 weeks|Twelve subjects completed questionnaires. Three subjects did not complete questionnaires.|||score on a scale||Inter-Quartile Range|Median
2543444|NCT02979535|Secondary|Number of Participants Reporting Cases of Virologically Confirmed Dengue (VCD) Hospitalization Following Vaccination With Cervarix or CYD Dengue Vaccine|Hospitalized suspected dengue case was defined as an acute febrile illness with diagnosis of dengue requiring hospitalization (with bed attribution). In such cases, 1 unplanned acute blood sample (within the first 5 days after fever onset) was collected for virological confirmation of hospitalized suspected dengue case. A suspected case was considered VCD if there was a detection of wild type dengue virus by dengue non-structural protein 1 antigen ELISA and/or dengue reverse transcriptase-polymerase chain reactions.|From Day 0 up to 6 months after the last CYD or Cervarix vaccination|Analysis was performed on safety analysis set.|||Participants|||Count of Participants
2543445|NCT02979535|Secondary|Number of Participants Reporting Serious Adverse Events (SAEs) Including Serious AESIs Following Vaccination With Cervarix or CYD Dengue Vaccine|An SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. An AESIs were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine.|From Day 0 up to 6 months after the last CYD or Cervarix vaccination|Analysis was performed on safety analysis set.|||Participants|||Count of Participants
2543446|NCT02979535|Secondary|Number of Participants Reporting Non-serious Adverse Event of Special Interests (AESIs) Following Vaccination With Cervarix or CYD Dengue Vaccine|AESI were AEs that were considered by the Sponsor to be relevant for the monitoring of the safety profile of the investigational vaccine.|Up to 7 days after any and each vaccination|Analysis was performed on safety analysis set. Here, 'number analyzed' signifies participants with available data for specified categories.|||Participants|||Count of Participants
2543447|NCT02979535|Secondary|Number of Participants Reporting Unsolicited AEs Following Vaccination With Cervarix or CYD Dengue Vaccine|An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.|Up to 28 days after any and each vaccination|"Analysis was performed on safety analysis set. Here, number analyzed signifies participants with available data for specified categories."|||Participants|||Count of Participants
2543448|NCT02979535|Secondary|Number of Participants Reporting Solicited Systemic Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine|Solicited systemic reactions included Fever, Headache, Malaise, Myalgia, and Asthenia. At Visit 1 and Visit 4, participants from Group 1 received both Cervarix and CYD vaccination and participants from Group 2 received only Cervarix vaccination. At Visit 2 and Visit 5, only participants from Group 2 received CYD vaccination whereas the participants from Group 1 received no vaccination.|Up to 14 days after any and each vaccination|"Analysis was performed on safety analysis set. Here, number analyzed signifies participants with available data for specified categories."|||Participants|||Count of Participants
2543449|NCT02979535|Secondary|Number of Participants Reporting Solicited Injection Site Reactions Following Vaccination With Cervarix or CYD Dengue Vaccine|Solicited injection site reactions included pain, erythema, and swelling.|Up to 7 days after each and any vaccination|"Analysis was performed on safety analysis set. Here, number analyzed signifies participants with available data for specified categories."|||Participants|||Count of Participants
2543450|NCT02979535|Secondary|Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With Cervarix or CYD Dengue Vaccine|Any unsolicited systemic AE occurred during the first 30 minutes post-vaccination was recorded on the case report form (CRF) as immediate AE.|Within 30 minutes after each and any vaccination|"Analysis was performed on safety analysis set which included those participants who had received at least one dose of the study vaccines. Here, number analyzed signifies participants with available data for specified categories."|||Participants|||Count of Participants
2543451|NCT02979535|Secondary|Percentage of Participants With Neutralizing Antibody Titers Above Pre-defined Thresholds Against Each Dengue Virus Serotypes of CYD at Baseline And 28 Days After Each Dose of CYD Dengue Vaccination in Dengue Seropositive Participants|Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers >=10 (1/dil) for at least one serotype with the parental dengue virus strain. Percentage of participants with neutralizing antibody titers above pre-defined thresholds (<10, >=10 and >=100 [1/dil]) against each dengue virus serotypes of CYD were reported.|Day 0 and 28 days after each CYD dengue vaccination|"Analysis was performed on FAS population. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants with available data for specified categories."|||percentage of participants||95% Confidence Interval|Number
2543452|NCT02979535|Secondary|Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against At Least 1,2,3,or4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in Previously Dengue Seropositive Participants|Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers >=10 (1/dil) for at least one serotype with the parental dengue virus strain.|Day 0 and 28 days after each CYD dengue vaccination|"Analysis was performed on FAS population. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants with available data for specified categories."|||percentage of participants||95% Confidence Interval|Number
2543545|NCT02976103|Secondary|EORTC QLQ-C30: Social Functioning Scale|2 items; score range 0-100 (higher score = better outcome)|1-2 weeks|T3 respondents|||score on a scale||Standard Deviation|Mean
2543546|NCT02976103|Secondary|EORTC QLQ-C30: Cognitive Functioning Scale|2 items; score range 0-100 (higher score = better outcome)|1-2 weeks|T3 respondents|||score on a scale||Standard Deviation|Mean
2543547|NCT02976103|Secondary|EORTC QLQ-C30: Emotional Functioning Scale|4 items; score range 0-100 (higher score = better outcome)|1-2 weeks|T3 respondents|||score on a scale||Standard Deviation|Mean
2543453|NCT02979535|Secondary|Percentage of Participants With Neutralizing Antibody Titers >=10 (1/Dil) Against Each of the 4 Dengue Virus Serotypes of CYD Dengue Vaccine at Day 0 And 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants|Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (Serotypes 1, 2, 3, and 4) were measured by PRNT50. Dengue seropositive participants at baseline were defined as those participants with titers >=10 (1/dil) for at least one serotype with the parental dengue virus strain.|Day 0 and 28 days after each CYD dengue vaccine vaccination|"Analysis was performed on FAS population. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants with available data for specified category."|||percentage of participants||95% Confidence Interval|Number
2543454|NCT02979535|Secondary|GMTs Against Each Dengue Virus Serotype of CYD Dengue Vaccine at Day 0 and 28 Days After Each Dose of CYD Dengue Vaccination in the Previously Dengue Seropositive Participants|The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the PRNT50 assay. Dengue seropositive participants at baseline were defined as those participants with titers >=10 (1/dil) for at least one serotype with the parental dengue virus strain.|Day 0 and 28 days after each CYD dengue vaccine vaccination|"Analysis was performed on FAS population. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants with available data for specified categories."|||titer (1/dilution)||95% Confidence Interval|Geometric Mean
2543455|NCT02979535|Secondary|Percentage of Participants With Seroconversion Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) 28 Days After Each Dose of Cervarix Vaccination in the Previously Dengue Seropositive Participants|Neutralizing antibodies against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Seroconversion was defined as changing serostatus from seronegative at baseline to seropositive (greater than [>] lower limit of quantitation [LLOQ] of the assay) or >=4-fold rise in antibody titer if seropositive at baseline (i.e., at least one antibody levels against Cervarix HPV antigens > LLOQ at baseline). The LLOQ for HPV-16 and HPV-18 was less than (<) 2.0 International Units per milliliter (IU/mL).|28 days after each Cervarix vaccination|"Analysis was performed on FAS population. Here, overall number of participants signifies participants evaluable for this outcome measure and number analyzed signifies participants with available data for specified category."|||percentage of participants||95% Confidence Interval|Number
2543456|NCT02979535|Secondary|GMTs Against Each Cervarix HPV Antigen (HPV-16 and HPV-18) at Day 0 and 28 Days After Each Cervarix Vaccination in the Previously Dengue Seropositive Participants|The GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an ELISA method. Dengue seropositive participants at baseline were defined as those participants with titers >=10 (1/dil) for at least one serotype with the parental dengue virus strain.|Day 0 and 28 days after each Cervarix vaccination|"Analysis was performed on FAS population. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure and number analyzed signifies participants with available data for specified categories."|||EU/mL||95% Confidence Interval|Geometric Mean
2543457|NCT02979535|Primary|GMTs Against Each Dengue Virus Serotype 28 Days After the Third CYD Dengue Vaccination in the Previously Dengue Seropositive Participants|The GMTs against each of the four parental dengue virus serotypes (Serotypes 1, 2, 3, and 4) of CYD dengue vaccine were assessed using the 50% plaque reduction neutralization test (PRNT50) assay. Dengue seropositive participants at baseline were defined as those participants with titers >=10 (1/dil) for at least one serotype with the parental dengue virus strain.|28 days after third CYD dengue vaccination|"Analysis was performed on the full analysis set (FAS) which was defined as the subset of participants who received at least one dose of the study vaccine. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure."|||titer (1/dilution)||95% Confidence Interval|Geometric Mean
2543458|NCT02979535|Primary|Geometric Mean Titers (GMTs) Against Each Cervarix Human Papillomavirus (HPV) Antigen (HPV-16 and HPV-18) 28 Days After Last Cervarix Vaccination in the Previously Dengue Seropositive Participants|GMTs against each Cervarix HPV antigen (HPV-16 and HPV-18) were assessed using an enzyme-linked immunosorbent assay (ELISA) method. Dengue seropositive participants at baseline were defined as those participants with titers greater than or equal to (>=) 10 (1/dilutions [dil]) for at least one serotype with the parental dengue virus strain.|28 days after the last Cervarix vaccination|Analysis was performed on per-protocol analysis set (PPS) for Cervarix which included participants who received at least one dose of Cervarix vaccine and had no relevant protocol deviations.|||Endotoxin Units per milliliter (EU/mL)||95% Confidence Interval|Geometric Mean
2543459|NCT02979444|Secondary|The Change in the Experiences Questionnaire From Baseline to 24-Weeks Postpartum|Decentering will be measured using the Experiences Questionnaire (EQ) (Fresco et al., 2007). The EQ is a 20 item self-report scale designed to measure decentering and rumination, which has demonstrated strong internal consistency in a number of studies examining effects of interventions that incorporate cognitive restructuring techniques. Response choices are on a 1-5 scale. For the purposes of our analyses, we created a mean EQ score (range 1-5), with higher scores indicating more decentering/rumination.|Baseline and 12 and 24-week follow-ups|Participants analyzed at 24-weeks postpartum|||score on a scale||Standard Deviation|Mean
2543460|NCT02979444|Secondary|The Change in the MOS Social Support Survey From Baseline to 24-Weeks Postpartum|Social support will be measured using the 19-item Medical Outcomes Study Social Support Survey (MOS-SSS) (Sherbourne & Stewart, 1991). This brief self-administered survey includes an overall functional social support index, as well as four functional support subscales: affectionate, emotional/informational, tangible, and positive social interaction. The range is 1-5 with greater scores indicating more perceived social support.|Baseline and 12 and 24-week follow-ups|Participants analyzed at the 24-week postpartum time point|||score on a scale||Standard Deviation|Mean
2543461|NCT02979444|Secondary|The Change in the Negative Mood Regulation Scale|Mood regulation will be measured using the 30-item Negative Mood Regulation Scale (NMRS) (Catanzaro & Means, 1990). For each question, respondents use a 5-point scale to indicate what they believe they can do when they are disappointed or experiencing a negative mood. For our analyses, these items were averaged to create a mean NMRS score (range 1-5). Higher scores indicate a greater ability to regulate one's mood.|Baseline and 12 and 24-week postpartum follow-ups|Participants analyzed at 24-weeks postpartum|||score on a scale||Standard Deviation|Mean
2543462|NCT02979444|Secondary|The Change in the Behavioral Activation Scale From Baseline to 24-weeks Postpartum|Behavioral Activation will be measured using the Behavioral Activation Depression Scale (BADS). The BADS assesses behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation strategies. It examines changes in the following areas: activation, avoidance/ rumination, work/school impairment, and social impairment. The BADS consists of 25 items, each rated on a seven point scale ranging from 0 (not at all) to 6 (completely). The range of the scale is 0-64. For the total scale, higher scores represent increased activation. The BADS has demonstrated strong internal consistency, construct validity, and predictive validity (Kanter et al, 2007; Kanter et al., 2009).|Baseline and 12 and 24-week postpartum follow-ups|Overall number of participants analyzed at 24-weeks postpartum|||score on a scale||Standard Deviation|Mean
2543463|NCT02979444|Primary|The Change in QIDS-16 Scores From Baseline to 24 Weeks Postpartum|Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16). The QIDS-SR16 was used to assess severity of depressive symptoms consistent with Diagnostic and Statistical Manual symptom criteria. Total scores range from 0-27; higher scores indicate greater symptomatology. The investigators anticipate a clinically meaningfully difference to be on the order of five points (as this is the difference in score on each severity level of depression) (Trivedi et al., 2004). For our non-inferiority analyses comparing MB led by home visitors vs. MB led by mental health clinicians, we will have >85% power to detect a difference difference in mean QIDS-16 scores of two points between the two active intervention arms.|Baseline and 12 and 24-week postpartum follow-up|These numbers reflect the number of study participants with complete data at our 24-week postpartum assessment.|||score on a scale||Standard Deviation|Mean
2543464|NCT02979431|Secondary|Immunogenicity; Number of Subjects With Treatment-emergent Neutralizing Antibodies|"Number of subjects with treatment-emergent neutralizing antibodies (TE NAb) as detected with the competitive ligand binding NAb assay. Blood samples for immunogenicity assessments were collected at Baseline and on Day 14.~Immunogenicity data were analyzed using the Safety Population. This population differs from the ITT and mITT Populations as 2 subjects who were originally randomized to placebo, received active treatment once; one subject received ALX-0171 6.0 mg/kg and one subject ALX-0171 9.0 mg/kg."|Overall Study Period (i.e., approximately 28 days)|The Safety Population consisted of all subjects who received at least 1 administration of study drug. When using this population, the subjects were classified as treated (i.e., using the treatment that the subject actually received).Number of subjects with non-missing NAb results were: placebo:39; ALX-0171 3.0mg/kg:45; 6.0mg/kg:44; 9.0mg/kg:46.|||Participants|||Count of Participants
2543465|NCT02979431|Secondary|Immunogenicity; Number of Subjects With Treatment-emergent Anti-drug Antibodies|"The number of subjects with treatment-emergent (TE) anti-drug antibodies (ADA; TE ADA) based on ADA assay by treatment group for the Safety Population. Blood samples for immunogenicity assessments were collected at Baseline and on Day 14.~Immunogenicity data were analyzed using the Safety Population. This population differs from the ITT and mITT Populations as 2 subjects who were originally randomized to placebo, received active treatment once; one subject received ALX-0171 6.0 mg/kg and one subject ALX-0171 9.0 mg/kg."|Overall Study Period (i.e., approximately 28 days)|The Safety Population consisted of all subjects who received at least 1 administration of study drug. When using this population, the subjects were classified as treated (i.e., using the treatment that the subject actually received). Number of subjects with non-missing ADA results were: placebo:39; ALX-0171 3.0mg/kg:45; 6.0mg/kg:44; 9.0mg/kg:46.|||Participants|||Count of Participants
2543466|NCT02979431|Secondary|Viral Load Time-weighted Average Changes From Baseline (RT-qPCR Analysis)|The time-weighted average change from baseline to Day x was defined as (AUCx - x* viral load at baseline) /x, where AUCx denotes the AUC between baseline and Day x. For subjects who only had data up to Day t (t<x), the endpoint was defined as (AUCt - t*viral load at baseline) / t.|From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported)|RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug.|||log10 copies/mL||Standard Error|Mean
2543467|NCT02979431|Secondary|Viral Load Time-weighted Average Changes From Baseline (Plaque Assay Analysis)|The time-weighted average change from baseline to Day x was defined as (AUCx - x* viral load at baseline) /x, where AUCx denotes the AUC between baseline and Day x. For subjects who only had data up to Day t (t<x), the endpoint was defined as (AUCt - t*viral load at baseline) / t.|From Baseline until Day 14 (Follow-up) (Baseline, Day 3, and Follow-up reported)|RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug.|||log10 pfu/mL||Standard Error|Mean
2543468|NCT02979431|Secondary|Viral Load Changes From Baseline (RT-qPCR Analysis)|Change from Baseline in RSV Load measured by RT-qPCR (RSV Infected Population)|From Baseline until Day 14 (Follow-up) (Baseline; Day 1, 5 hours post-dose; Day 3, 2 hours post-dose; and Follow-up reported)|RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug.|||log10 copies/mL||Standard Error|Mean
2543469|NCT02979431|Secondary|Viral Load Changes From Baseline (Plaque Assay Analysis)|Change from Baseline in RSV Load measured by Plaque Assay (RSV Infected Population)|From Baseline until Day 14 (Follow-up) (Baseline; Day 1, 5 hours post-dose; Day 3, 2 hours post-dose; and Follow-up reported)|RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug.|||log10 pfu/mL||Standard Error|Mean
2543548|NCT02976103|Secondary|EORTC QLQ-C30: Role Functioning Scale|2 items; score range 0-100 (higher score = better outcome)|1-2 weeks|T3 respondents|||score on a scale||Standard Deviation|Mean
2543549|NCT02976103|Secondary|EORTC QLQ-C30: Physical Functioning Scale|5 items; score range 0-100 (higher score = better outcome)|1-2 weeks|T3 respondents|||score on a scale||Standard Deviation|Mean
2543550|NCT02976103|Secondary|EORTC QLQ-C30: Global QOL Scale|2 items; score range 0-100 (higher score = better outcome)|1-2 weeks|T3 respondents|||score on a scale||Standard Deviation|Mean
2543470|NCT02979431|Secondary|Time-to-undetectable Viral Load (Plaque Assay Analysis)|The time-to-undetectability (hours), defined as the time from the first study drug administration to the first occurrence of viral titer below the lower limit of quantification (LLOQ), and target not detected provided the next measured value was also below the quantification limit and undetected, were summarized using KM estimates, based on the plaque assay. The time-to-event for subjects with missing data and/or subjects who did not reach undetectability during the trial were censored at the last non-missing viral load assessment. For RSV load by plaque assay the LLOQ was 1.7 log10 pfu/mL.|Overall Study Period (i.e., approximately 28 days)|RSV-Infected Population: A central RSV test was used for defining the RSV-Infected population. The RSV-Infected population consisted of all randomized subjects with RSV infection, as confirmed by RT-qPCR (hVIVO quantitative PCR assay) on Day 1 (pre- or post-dose), who received at least 1 administration of study drug.|||hours||95% Confidence Interval|Median
2543471|NCT02979431|Secondary|Time-to-BQL (RT-qPCR)|"As secondary endpoint, the time-to-BQL using RT-qPCR was summarized using Kaplan Meier (KM) estimates. No p-values were calculated. For RSV load by RT-qPCR, the lower limit of quantification (LLOQ) was 2.4 log10 copies/mL.~The upper limit confidence interval (CI) could not be calculated; Values of the 25 percentile are reported here."|Overall Study Period (i.e., approximately 28 days)|The modified ITT (mITT) population consisted of all randomized subjects who received at least 1 administration of study drug. When using this population, the subjects were classified as randomized (i.e., using the treatment to which the subject was randomized).|||hours||95% Confidence Interval|Median
2543472|NCT02979431|Secondary|Time-to-Clinical Response|The time-to-clinical response was defined as the time between the first study drug administration and the time of achieving adequate oxygen saturation (defined as SpO2 > 92% over a period of at least 4 hours) and adequate oral feeding (which is sufficient to maintain sufficient hydration, in the judgment of the Investigator).|Overall Study Period (i.e., approximately 28 days)|modified Intent-to-Treat Population (mITT): All randomized subjects who received at least 1 study drug administration. In this population, the subjects were classified as randomized (i.e.,using the treatment to which the subject was randomized).|||hours||95% Confidence Interval|Median
2543473|NCT02979431|Secondary|Change From Baseline in Global Severity Score on Day 2 (5 Hours Post-dose)|"A formal comparison for change from Baseline in GSS to Day 2, 5 hours post-dose was performed using a contrast analysis on a longitudinal mixed model with random factor subject and fixed effects baseline value, treatment group and timepoint, including the treatment-by-timepoint interaction term. All data up to and including Day 3 were used in the longitudinal mixed model. The Kenward-Roger approximation of degrees of freedom was used. The model was fitted using an unstructured variance-covariance matrix.~The individual pair-wise comparisons were reported (comparison in least square [LS] means for 9.0 mg/kg versus placebo; 6.0mg/kg versus placebo; 3.0 mg/kg versus placebo).~Evolution over time in Global Severity Score. The maximum total score is 20 (minimum:0 to manimum:20); higher score indicates more severe disease."|from Baseline untill Day 2 (5 hours post-dose)||||score on a scale||Standard Error|Least Squares Mean
2543474|NCT02979431|Primary|Time for Viral Load to Drop Below Assay Quantification Limit (BQL) (Plaque Assay Analysis)|The primary endpoint for this trial was the time needed for the viral load to drop below the quantification limit (time-to-BQL) of the plaque assay in nasal mid-turbinate swab specimens. Time-to-BQL was defined as the time from the first study drug administration to the first occurrence of a value below the quantification limit (BQL), provided the next measured value was also below the limit of quantification. The time to BQL for subjects with missing data and/or who did not reach BQL during the trial were censored at the last non-missing viral load assessment. The primary endpoint was analysed using logrank test to compare time-to-BQL between each of the ALX-0171 treatment groups and the combined placebo group. The tests were performed in a sequential way to preserve the family-wise error rate at 0.05. The comparisons were performed in the following order: ALX-0171 9 mg/kg vs Placebo, followed by ALX-0171 6mg/kg vs Placebo, ALX-0171 3mg/kg vs Placebo.|Overall Study Period (i.e., approximately 28 days)|modified Intent-to-Treat Population (mITT): All randomized subjects who received at least 1 study drug administration. In this population, the subjects were classified as randomized (i.e.,using the treatment to which the subject was randomized).|||hours||95% Confidence Interval|Median
2543475|NCT02979301|Primary|Change in Background Parenchymal Uptake (BPU) on Molecular Breast Imaging (MBI)|An image analysis tool to obtain a quantitative measure of background parenchymal uptake (BPU) was applied to pre-tamoxifen and post-tamoxifen MBI exams. The percent change in BPU from pre-tamoxifen to post-tamoxifen MBI was determined.|30 days||||percent change in BPU||Standard Deviation|Mean
2543476|NCT02979262|Secondary|Change in Days of Substance Use Reported on the Time Line Follow-Back Calendars|Number of days of substance use over the course of the study. Higher scores equal more days of substance use. Possible range of scores was from 0 to 210 days. Change over time is reported as the slope.|At intervention completion (around week 16) and 3 months post intervention (at around 28 weeks)||||ratio score baseline to 28 weeks||Standard Error|Mean
2543477|NCT02979262|Secondary|Change in Coparenting Relationship Scale|Brief Coparenting score which is calculated from a sum of 14 scale items. Scores range from 0 to 84 with higher scores indicating better coparenting. Change over time is reported as the slope.|Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28||||ratio score baseline to 28 weeks||Standard Error|Mean
2543478|NCT02979262|Secondary|Change in Total Score on the Adult Adolescent Parenting Inventory|Overall score is indicator of maltreatment risk. A total score is calculated by summing the 5 scales with lower scores indicating greater risk for maltreatment. The range of scores is from 40 to 200. Change over time is reported as the slope.|Baseline, intervention completion around 16 weeks, and 3 month post intervention around week 28||||ratio score baseline to 28 weeks||Standard Error|Mean
2543479|NCT02979262|Secondary|Change in Number of Domestic Violence Episodes on the Timeline Follow-Back Calendars|Domestic Violence including physical and psychological aggression episodes across the length of followup. Higher scores mean more violence. Scores can range from 0 to 210 days. Change over time is reported as the slope.|Baseline through 3 month follow-up after intervention||||ratio score baseline to 28 weeks||Standard Deviation|Mean
2543551|NCT02976103|Secondary|PROMIS Pain Interference Scale - Short Form 8a|8 items (T score 0-100); higher score = worse outcome|1-2 weeks|13 participants in the Standard Care arm and 10 in the Jacki Jacket arm (total of 23) did not complete answer the T3 questionnaire or did not answer all items required to calculate a score|||score on a scale||Standard Deviation|Mean
2543481|NCT02979262|Primary|Hostile Thoughts on the Articulated Thoughts in Simulated Situations Task|Hostile Thinking coded from audio recorded transcripts. Participants are presented with 4 scenarios in which they are asked to respond verbally their thoughts about a given situation. The scenarios present incidents that could induce feelings of jealousy, anger, abandonment, or disrespect. These are coded for number of hostile cognitions by trained blind coders and summed for a total score. The range of scores is 0 to 28 . Higher scores mean greater hostile cognitions (worse outcome).|Baseline and intervention completion around 16 weeks|Participants completed this assessment at baseline and 16 weeks only. We had some participants who refused to complete this specific measure at the post assessment and therefore we have less participants for analysis.|||score on a scale||Standard Error|Mean
2543482|NCT02979197|Other Pre-specified|Change in Serum Creatinine|Subjects had blood collected for the measurement of creatinine at the Initial Screening Visit (Day -10 to -14), at Baseline (Day 0), and at Days 7 and 14. Change in serum creatinine was calculated by subtracting the Baseline value from the end of treatment value (recorded on Day 14). A negative value for change in serum creatinine indicates a decrease in creatinine and a positive value indicates an increase.|Baseline and 14 Days|Safety population = all randomized subjects who received at least one dose of study drug|||μmol/L||Standard Deviation|Mean
2543483|NCT02979197|Secondary|Log-transformed Plasma Concentration of Amlodipine|A venous blood sample was collected 24 hours ± 1 hour after the last dose of study drugs (i.e., on Day 14). The blood sample was processed to plasma and the concentration of amlodipine measured using a validated LC-MS/MS method. The concentrations were logarithmically transformed and used for the comparison between the amlodipine+celecoxib and amlodipine+placebo arms to evaluate the effect of celecoxib on the mean log-transformed plasma concentrations of amlodipine.|24 hours post-dose on Day 14|PK population = all subjects enrolled at an Investigational Site with ultraviolet- (UV-) shielded lights who had blood drawn on Day 14, 24 hours ± 1 hour after receiving the final dose of study drugs for the measurement of plasma amlodipine concentration; only treatment arms that included amlodipine were included in the analyses.|||ng/mL||Standard Deviation|Mean
2543484|NCT02979197|Secondary|Non-transformed Plasma Concentration of Amlodipine|A venous blood sample was collected 24 hours ± 1 hour after the last dose of study drugs (i.e., on Day 14). The blood sample was processed to plasma and the concentration of amlodipine measured using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The resulting concentrations, without logarithmic transformation, were used for the comparison between the amlodipine+celecoxib and amlodipine+placebo arms to evaluate the effect of celecoxib on the mean non-transformed plasma concentrations of amlodipine.|24 hours post-dose on Day 14|Pharmacokinetic (PK) population = all subjects enrolled at an Investigational Site with ultraviolet- (UV-) shielded lights who had blood drawn on Day 14, 24 hours ± 1 hour after receiving the final dose of study drugs for the measurement of plasma amlodipine concentration; only treatment arms that included amlodipine were included in the analyses.|||ng/mL||Standard Deviation|Mean
2543485|NCT02979197|Secondary|Occurrence of Treatment Emergent Adverse Events|Treatment emergent adverse events (TEAEs) included any untoward medical occurrence that initiated or worsened after the first dose of study drugs and within 14 days of the last dose of study drugs.|1 month|Safety population = all randomized subjects who received at least one dose of study drug. The occurrence of TEAEs was compared between all three arms (Chi-square test), as well as between the amlodipine+celecoxib and amlodipine+placebo arms (exact logistic regression model). Comparison to placebo+placebo was not part of this latter analysis.|||Participants|||Count of Participants
2543486|NCT02979197|Secondary|Change in Creatinine Clearance|Subjects had blood collected for the measurement of creatinine at the Initial Screening Visit (Day -10 to -14), at Baseline (Day 0), and at Days 7 and 14. Estimated creatinine clearance was calculated using Cockcroft-Gault equation: (140 - age) X body weight (kg)/72 X serum creatinine concentration (mg/dL); multiplied by 0.85 for women. Change in creatinine clearance was calculated by subtracting the Baseline value from the end of treatment value (recorded on Day 14). If the Day 14 value was not available, the Day 7 value was used (LOCF method). A negative value for change in creatinine clearance indicates a decrease in creatinine clearance and a positive value indicates an increase.|Baseline and 14 days|ITT population [i.e., all randomized subjects with a valid Baseline (Day -1 to Day 0) ABPM measurement]. A secondary endpoint of this trial was the comparison of the mean change in creatinine clearance between the amlodipine+celecoxib and amlodipine+placebo arms (superiority trial). Comparison to placebo+placebo was not part of this endpoint.|||mL/min||Standard Deviation|Mean
2543487|NCT02979197|Secondary|Change in Average 24-hour Ambulatory Diastolic Blood Pressure (DBP24h)|An ABPM fitted to upper arm was used for continuous recording of blood pressure over three 25-hour periods: Days -1 to 0 (Baseline), Days 6 to 7, & Days 13 to 14. The ABPM recorded blood pressure every 20 minutes between 09:00 and 21:59 and every 30 minutes between 22:00 and 08:59. DBP24h was calculated by averaging all of the diastolic blood pressure measurements between the protocol-defined first & last study measurements of the period; measurements during the first hour (white-coat window) were not included. Change in DBP24h was calculated by subtracting the Baseline value from the end of study value (Day 13 to Day 14 period). If the Day 13 to Day 14 value was not available, the Day 6 to Day 7 value was used (LOCF method). A negative value for change in DBP24h indicates a decrease in diastolic blood pressure and a positive value indicates an increase.|Baseline and 14 days|ITT population [i.e., all randomized subjects with a valid Baseline (Day -1 to Day 0) ABPM measurement]. A secondary endpoint of this trial was the comparison of the mean change in DBP24h between the amlodipine+celecoxib and amlodipine+placebo arms (superiority trial). Comparison to placebo+placebo was not part of this endpoint.|||mmHg||Standard Deviation|Mean
2543501|NCT02978339|Secondary|Change in Pruritus|"Pruritus will be measured by the 5-D itch Scale. The 5-D itch scale was developed as a brief but multidimensional questionnaire designed to be useful as an outcome measure in clinical trials. The five dimensions are degree, duration, direction, disability and distribution. The duration, degree and direction domains each include one item, while the disability domain has four items. All items of the first four domains were measured on a five‐point Likert scale (1 = Not present/resolved/never, 5 = Unbearable/getting worse/always).The distribution domain included 16 potential locations of itch, including 15 body part items and one point of contact with clothing or bandages.The scores of each of the five domains are achieved separately and then summed together to obtain a total 5‐D score. 5‐D scores can potentially range between 5 (no pruritus) and 25 (most severe pruritus)"|Baseline, 12 weeks|Twelve of the subjects completed questionnaires. Three subjects did not complete questionnaires|||score on a scale||Inter-Quartile Range|Median
2543488|NCT02979197|Secondary|Change in Average 24-hour Ambulatory Systolic Blood Pressure (SBP24h)|An ABPM fitted to upper arm was used for continuous recording of blood pressure over three 25-hour periods: Days -1 to 0 (Baseline), Days 6 to 7, & Days 13 to 14. The ABPM recorded blood pressure every 20 minutes between 09:00 and 21:59 and every 30 minutes between 22:00 and 08:59. SBP24h was calculated by averaging all of the systolic blood pressure measurements between the protocol-defined first & last study measurements of the period; measurements during the first hour (white-coat window) were not included. Change in SBP24h was calculated by subtracting the Baseline value from the end of study value (Day 13 to Day 14 period). If the Day 13 to Day 14 value was not available, the Day 6 to Day 7 value was used (LOCF method). A negative value for change in SBP24h indicates a decrease in systolic blood pressure and a positive value indicates an increase.|Baseline and 14 days|ITT population [i.e., all randomized subjects with a valid Baseline (Day -1 to Day 0) ABPM measurement]. A secondary endpoint of this trial was the comparison of the mean change in SBP24h between the amlodipine+celecoxib and amlodipine+placebo arms (superiority trial). Comparison to placebo+placebo was not part of this endpoint.|||mmHg||Standard Deviation|Mean
2543489|NCT02979197|Secondary|Change in Body Weight|Body weight was measured at the Initial Screening Visit (Day -10 to -14), at Baseline (Day 0), and at Days 7 and 14. The measurements were made using a calibrated scale with the subject wearing underwear and a light gown. Change in body weight was calculated by subtracting the Baseline value from the end of treatment value (recorded on Day 14). If the Day 14 value was not available, the Day 7 value was used (LOCF method). A negative value for change in body weight indicates a decrease in body weight and a positive value indicates an increase.|Baseline and 14 days|ITT population [i.e., all randomized subjects with a valid Baseline (Day -1 to Day 0) ABPM measurement]. A secondary endpoint of this trial was a comparison of the mean change in body weight between all three treatment arms [analysis of variance (ANOVA) F test]. Thus, mean values for all three arms are presented.|||kg||Standard Deviation|Mean
2543490|NCT02979197|Primary|Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday)|An ambulatory blood pressure monitor (ABPM) fitted to upper arm was used for continuous recording of blood pressure over three 25-hour periods: Days -1 to 0 (Baseline), Days 6 to 7, & Days 13 to 14. The ABPM recorded blood pressure every 20 minutes between 09:00 and 21:59 and every 30 minutes between 22:00 and 08:59. SBPday was calculated by averaging all of the systolic blood pressure measurements between the protocol-defined first & last study measurements of the period that fell between 9:00 and 21:00; measurements during the first hour (white-coat window) were not included. Change in SBPday was calculated by subtracting the Baseline value from the end of study value (Day 13 to Day 14 period). If the Day 13 to Day 14 value was not available, the Day 6 to Day 7 value was used [last observation carried forward (LOCF) method]. A negative value for change in SBPday indicates a decrease in systolic blood pressure and a positive value indicates an increase.|Baseline and 14 days|Intent-to-treat (ITT) population = all randomized subjects with a valid Baseline (Day -1 to Day 0) ABPM measurement. The primary endpoint of this trial was a comparison of the mean change in SBPday between the amlodipine+celecoxib and amlodipine+placebo arms (non-inferiority trial). Comparison to placebo+placebo was not part of primary endpoint.|||mmHg||Standard Deviation|Mean
2543491|NCT02979054|Secondary|Number of Participants With Treatment-emergent Adverse Events||Through study completion, an average of 1 month|Safety set (137 treated participants)|||Participants|||Count of Participants
2543492|NCT02979054|Secondary|Corneal Epithelial Defect Size Assessment||Baseline and Day 5|mITT set (135 participants) analysed results. 137 treated participants: 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.|||mm^2||Standard Deviation|Mean
2543493|NCT02979054|Primary|Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 4||Day 4|mITT set (135 participants) analysed results. 137 treated participants: 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.|||Participants|||Count of Participants
2543494|NCT02979054|Primary|Number of Participants With Complete Healing of Corneal Epithelial Defect at Day 3||Day 3|mITT set (135 participants) analysed results. 137 treated participants: 73 treated patients with T4020 but 2 patients treated but not randomised. These 2 patients were excluded from the mITT set.|||Participants|||Count of Participants
2543495|NCT02978833|Secondary|Pain During Forward Step-down Test|"Pain will be assessed using the 10-cm Visual Analog Scale, which will range from no pain to worst possible pain."|Up to 1 year post-injection|This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.||||||
2543496|NCT02978833|Secondary|Pain During Side-lying Hip Abduction|"Pain will be assessed using the 10-cm Visual Analog Scale, which will range from no pain to worst possible pain."|Up to 1 year post-injection|This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.||||||
2543497|NCT02978833|Secondary|Quality of Movement During the Forward Step-down Test|"The quality of movement will be assessed on a scale of 0-4+, where 4+=good, 2-3=moderate, and 0-1=poor."|Up to 1 year post-injection|This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.||||||
2543498|NCT02978833|Primary|Patient Satisfaction|"The 10-cm Visual Analog Scale for patient satisfaction will be used. This scale will range from very dissatisfied to extremely satisfied."|Up to 1 year post-injection|This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.||||||
2543499|NCT02978833|Primary|Improvement in Function|The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function.|Up to 1 year post-injection|This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.||||||
2543500|NCT02978833|Primary|Improvement in Pain|The Numerical Rating Scale for Pain will be used, where 0=no pain and 10=worst pain. A higher number represents more pain.|Up to 1 year post-injection|This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.||||||
2543552|NCT02976103|Secondary|PROMIS Pain Intensity Scale (Short Form 3a)|3 items (T score 0-100); higher score = worse outcome|1-2 weeks|13 participants in the Standard Care arm and 9 in the Jacki Jacket arm (Total of 21) did not provide complete data to calculate this scale|||score on a scale||Standard Deviation|Mean
2545261|NCT02948634|Primary|The Revised Symptom Impact Questionnaire|Self-Report Questionnaire containing 21 questions, maximum/worse score=100; minimum/best score=0.|baseline, 1 week, and 1 month after treatment||||score on a scale||Standard Deviation|Mean
2543503|NCT02978339|Secondary|Change in Mayo Primary Sclerosing Cholangitis (PSC) Risk Score|"The Mayo Risk Score (R) = (0.0295 * (age in years)) + (0.5373 * natural logarithm(total bilirubin in mg/dL)) - (0.8389 * (serum albumin in g/dL)) + (0.5380 * natural logarithm(AST in IU/L) + (1.2426 * (points for variceal bleeding)) where:~AST = serum aspartate aminotransferase level, Points for variceal bleeding: 0 if none, 1 if present. Each unit increase in the Mayo Risk Score (R) is associated with a 2.5-fold increase in the risk of death. Most references to the score round the coefficients to 2 decimal places. The score shows very slight upward slope over time in stable patients, but during the terminal phase it shows an acceleration in progression."|Baseline, 12 weeks|Twelve subjects completed questionnaires. Three subjects did not complete questionnaires|||score on a scale||Inter-Quartile Range|Median
2543504|NCT02978339|Secondary|Change in C-Reactive Protein (CRP)|C-reactive protein is a substance produced by the liver in response to inflammation. Normal CRP levels are below 3.0 milligrams/Liter (mg/L)|Baseline, 12 weeks||||mg/L||Inter-Quartile Range|Median
2543505|NCT02978339|Secondary|Change in Total Bilirubin|Bilirubin is a yellowish pigment found in bile, a fluid made by the liver. A small amount of older red blood cells are replaced by new blood cells every day. Bilirubin is left after these older blood cells are removed. The liver helps break down bilirubin so that it can be removed from the body in the stool. The normal range for total bilirubin is 0.3 to 1.9 milligrams/deciliter (mg/dL)|Baseline, 12 weeks||||mg/dL||Inter-Quartile Range|Median
2543506|NCT02978339|Secondary|Change in Serum Aspartate Aminotransferase (AST)|AST is an enzyme found in high amounts in liver, heart, and muscle cells. This test is mainly done along with other tests such as alkaline phosphatase and bilirubin to diagnose and monitor liver disease. This test evaluates hepatocyte integrity, as serum levels of this enzyme rise in response to a variety of forms of injury to hepatic cells. The normal range is 10 to 40 Unit/Liter (U/L)|Baseline, 12 weeks||||U/L||Inter-Quartile Range|Median
2543507|NCT02978339|Primary|Change in Serum Alkaline Phosphatase (SAP)|Number of subjects who experience a reduction of Serum Alkaline Phosphatase (SAP) to less than 1.5 x Upper Limit of Normal or a 40% reduction between baseline and week 12.|baseline, 12 weeks||||Participants|||Count of Participants
2543508|NCT02978157|Primary|Number of Participants in Which H. Pylori Was Eradicated|Number of participants with negative H pylori status in follow-up tests as a measure of successful eradication|six weeks after the end of anti-H pylori therapy.|Intention to treat|||participants|||Number
2543509|NCT02977572|Secondary|Hospital Mortality|Mortality during hospital stay (including at Intensive care mortality)|Mortality (%) at Hospital at discharge from hospital||||Participants|||Count of Participants
2543510|NCT02977572|Secondary|28th Day Mortality|Mortility of patients within of the first 28 days after randomization (either at intensive car unit or at hospital)|Mortality within 28 days of randomization||||Participants|||Count of Participants
2543511|NCT02977572|Secondary|Intensive Care Unit Mortality|Mortality (%) at Intensive Care Unit|Mortality (%) at Intensive Care Unit at discharge from intensive care unit||||Participants|||Count of Participants
2543512|NCT02977572|Secondary|Length of Hospital Stay|All the time (days) the patient stays at the hospital|Length of stay (days) at hospital at discharge from hospital||||days||Inter-Quartile Range|Median
2543513|NCT02977572|Secondary|Length of Stay at Intensive Care Unit|Length of stay of the patient at Intensive Care Unit|Length of stay (days) at Intensive Care Unit at discharge from intensive care unit.||||days||Inter-Quartile Range|Median
2543514|NCT02977572|Secondary|Acute Renal Failure|Development of acute renal failure measured as increase of level of creatinine|Acute Renal Failure during intensive care unit stay (at discharge from intensive care unit)||||Participants|||Count of Participants
2543515|NCT02977572|Secondary|Ventilator Acquired Pneumonia|Pulmonary infections (%) during stay at intensive care unit|Pulmonary infection at intensive care unit diagnosed until 72 hours after removal of ventilation||||Participants|||Count of Participants
2543516|NCT02977572|Secondary|Duration of the Ventilation|Period of ventilation (either noninvasive ventilation or continouos positive airway pressure) while the patient suffers from acute respiratory failure secondary to cardiopulmonary edema|Time (hours) from start of ventilation until the removal of both devices because of improve or failure||||hours||Inter-Quartile Range|Median
2543517|NCT02977572|Primary|Need for an Endotracheal Intubation Within Seven Days After Onset of Cardiopulmonary Edema at the Intensive Care Unit||Whitin seven days after onset of cardiopulmonary edema at the Intensive Care Unit||||Participants|||Count of Participants
2543518|NCT02977507|Secondary|Change From Baseline in Mexameter Measurement of Target Hyperpigmentation Lesion to Week 12|"Two target hyperpigmented lesions were selected from the left and the right malar facial areas and were measured by the mexameter, an instrument that measures melanin content. One target normal measurement was also taken from an unaffected skin area on the face representing normal skin. The values from the target hyperpigmented lesions were compared to the normal lesion value. The range of melamin index and erythema is 0 to 999 Arbitrary Units (AU). A negative change from Baseline indicates improvement."|Baseline (Day 1) to Week 12|ITT population included all enrolled participants with at least one follow-up visit. Number analyzed is the number of participants with data available for analysis at the given time-point.|||AU|facial sides|Standard Deviation|Mean
2543519|NCT02977507|Secondary|Investigator's Global Improvement Assessment for Overall Hyperpigmentation Score to Week 12|Investigator's global improvement assessment score was used for assessment of overall hyperpigmentation on the left and right facial sides. The score ranged from 0 to 4 where, 0=No change or worsening, 1=Mild improvement (approximately 25% overall improvement), 2=Moderate improvement (approximately 50% overall improvement), 3=Marked improvement (approximately 75% overall improvement), 4=Complete clearing/Dramatic improvement (approximately 95% plus overall improvement). The mean score for overall hyperpigmentation was reported.|Week 12|ITT population included all enrolled participants with at least one follow-up visit. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale|facial sides|Standard Deviation|Mean
2543553|NCT02976103|Secondary|Symptom Distress Scale - Pain Intensity|1 item (score range 1-5); higher score = worse outcome|1-2 weeks|14 participants in the standard care arm and 8 in the Jacki Jacket arm (total of 21) did not answer the T3 questionnaire or did not answer this item|||score on a scale||Standard Deviation|Mean
2558388|NCT02694549|Primary|Primary Performance Endpoint|Device failure: Incidence at 30 days of bleedings requiring additional treatments of the puncture site|30 days||||Participants|||Count of Participants
2543520|NCT02977507|Secondary|Change From Baseline in Melasma Quality of Life (MELASQOL) Scale Total Score to Week 12|The Melasma Quality of Life Scale assesses the effect melasma has on the quality of life of sufferers on a scale of 1 (not bothered at all) to 7 (bothered all of the time), rating the following questions: 1.The appearance of your skin condition 2.Frustration about your skin condition. 3.Embarrassment about your skin condition. 4.Feeling depressed about your skin condition. 5.The effects of your skin condition on your interactions with other people. 6.The effects of your skin condition on your desire to be with people. 7.Your skin condition making it hard to show affection. 8.Skin discoloration making you feel unattractive to others. 9.Skin discoloration making you feel less vital or productive. 10.Skin discoloration affecting your sense of freedom. The MELASQOL is scored from 7 to 70, with a higher score indicating worse melasma-related health-related quality of life. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Week 12|ITT population included all enrolled participants with at least one follow-up visit. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale|facial sides|Standard Deviation|Mean
2543521|NCT02977507|Secondary|Number of Participants by Responses for Self-Assessment Questionnaire: Test Product Preference|Using the Subject Self-Assessment Questionnaire: Facial Side Preference, the participant selected based on their experience, the Test Product they preferred to use.|Weeks 4, 8 and 12|ITT population included all enrolled participants with at least one follow-up visit. Number analyzed is the number of participants with data available for analysis at the given time-point.|||Participants|||Count of Participants
2543522|NCT02977507|Secondary|Number of Participants by Responses for Self-Assessment Questionnaire: Overall Satisfaction With the Test Product|Using the Subject Self-Assessment Questionnaire: Satisfaction with Treatment, the participant selected a response that best represented their overall satisfaction with the test product. Responses were categorized as: 1=Excellent (very satisfied), 2=Good (moderately satisfied), 3=Fair (slightly satisfied) and 4=Poor (not satisfied at all).|Weeks 4, 8 and 12|ITT population included all enrolled participants with at least one follow-up visit. Number analyzed is the number of participants with data available for analysis at the given time-point.|||Participants|||Count of Participants
2543523|NCT02977507|Secondary|Number of Participants by Responses for Self-Assessment Questionnaire: Overall Improvement in Skin Condition|Using the Subject Self-Assessment Questionnaire: Overall Improvement, the participant selected a response that best represented their feelings on the overall improvement in their skin condition compared to the beginning of the study. Responses were categorized as: 0=No change or a worsening in my skin condition (dark areas of color on skin), 1=I see a slight improvement in my skin condition (approximately 25% overall improvement), 2=I see a moderate improvement in my skin condition (approximately 50% overall improvement), 3=I see a marked improvement in my skin condition (approximately 75% overall improvement), 4=I see a complete clearing of my skin condition (approximately 95% or better overall improvement).|Baseline (Day 1) to Weeks 4, 8 and 12|ITT population included all enrolled participants with at least one follow-up visit. Number analyzed is the number of participants with data available for analysis at the given time-point.|||Participants|||Count of Participants
2543524|NCT02977507|Primary|Change From Baseline in Melasma Area and Severity Index (MASI) Score to Week 12|The investigator assigned a grade for the left and right facial sides for each of the following: A=Total Area Involved (0=No involvement to 6=90 to 100% involvement); D=Darkness of Pigment (0=Normal skin color to 4=Severe hyperpigmentation); and H=Homogeneity (0=Normal skin color without evidence of hyperpigmentation to 4=Uniform skin involvement without any clear areas). Total Half-Face MASI score was calculated as: Half Forehead 0.15(D+H)A + One Malar Side 0.3 (D+H)A + Half Chin 0.05(D+H)A. A negative change from Baseline indicates improvement.|Baseline (Day1) to Week 12|ITT population included all enrolled participants with at least one follow-up visit. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale|facial sides|Standard Deviation|Mean
2543525|NCT02977507|Primary|Change From Baseline in Overall Hyperpigmentation Scale Score to Week 12|The investigator assessed the participant's left and right facial sides for overall hyperpigmentation using the Overall Hyperpigmentation ten-point scale ranging from 0 to 9, where Score 0=None, skin is normal in color with no evidence of hyperpigmentation; Score 1, 2 or 3=Mild, several brown spots with increased pigmentation, they are small in size and slightly darker than surrounding skin; Score 4, 5 or 6=Moderate, many brown spots with increased pigmentation, they are medium in size and much darker than surrounding skin; Score of 7, 8 or 9=Severe, many large brown spots with increased pigmentation, they are large in size and markedly darker than surrounding skin. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Week 12|ITT population included all enrolled participants with at least one follow-up visit. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale|facial sides|Standard Deviation|Mean
2543526|NCT02977507|Primary|Change From Baseline in Melasma Severity Rating Scale Score to Week 12|The investigator assessed the participant's facial skin for the severity of symmetrical facial melasma on the left and the right side of the face using the Melasma Severity Rating Scale. The score ranges from 0 to 3, where 0=Cleared: color of melasma lesions approximately equivalent to surrounding normal skin or with minimal residual hyperpigmentation, 1=Mild: color slightly darker than the surrounding normal skin, 2=Moderate: color moderately darker than the surrounding normal skin and 3=Severe: color markedly darker than the surrounding normal skin. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Week 12|Intent-to-treat (ITT) Population included all enrolled participants with at least one follow-up visit. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale|facial sides|Standard Deviation|Mean
2543527|NCT02976519|Secondary|Area Under the Concentration-time Curve of the BI 443651 in Plasma Over the Time Interval From 0 to 12 Hours After the Administration of the First Dose (AUC0-12) on Day 1 and After the 13th Dose (AUC0-12,13) on Day 7 in Part 1|Area under the concentration-time curve of the BI 443651 in plasma over the time interval from 0 to 12 hours (h) after the administration of the first dose (AUC0-12) on day 1 and after the 13th dose (AUC0-12,13) on day 7 in Part 1. Pharmacokinetic samples were collected at 00:15 h:m pre-dose and at 00:15, 00:30, 00:45, 1:00, 2:00, 4:00, 6:00, 8:00 and 11:45 h:m after first drug administration on day 1 (for AUC0-12) and after last drug administration on day 7 (for AUC0-12,13).|Day 1 and Day 7 (Please check the measure description for detailed timeframe)|PKS|||pmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2543528|NCT02976519|Secondary|Maximum Measured Concentration of the BI 443651 in Plasma After the Administration of the First Dose (Cmax) on Day 1 and Over the Time Interval From 0 to 12 h After the 13th Dose (Cmax,13) on Day 7, in Part 1|Maximum measured concentration of the BI 443651 in plasma after the administration of the first dose (Cmax) on day 1 and over the time interval from 0 to 12 h after the 13th dose (Cmax,13) on day 7, in Part 1. Pharmacokinetic samples were collected at 00:15 hours:minutes (h:m) pre-dose and at 00:15, 00:30, 00:45, 1:00, 2:00, 4:00, 6:00, 8:00 and 11:45 h:m after first drug administration on day 1 (for Cmax) and after last drug administration on day 7 (for Cmax,13).|Day 1 and Day 7 (Please check the measure description for detailed timeframe)|Pharmacokinetic (PK) set (PKS): The PKS included all subjects in the TS who provided at least 1 PK parameter that was not excluded.|||picomole (pmol)/Litre (L)||Geometric Coefficient of Variation|Geometric Mean
2543529|NCT02976519|Primary|Percentage of Participants With Treatment-emergent Adverse Events (TEAE) Over the Treatment Period in Part 1 and Part 2|Percentage of participants with treatment-emergent adverse events (TEAE) over the treatment period in Part 1 and Part 2. For Part 1: From the first dose of study medication up to 30 days after the day of last intake of study medication, up to 44 days. For Part 2: From the first dose of study medication up to 30 days after the day of last intake of study medication, up to 51 days.|Up to 44 days (for Part 1) or 51 days (for Part 2) (Please check the measure description for detailed timeframe)|TS|||Percentage of participants (%)|||Number
2543530|NCT02976181|Secondary|Number of SND Subjects Receiving a Referral for an Indicated IPG Device After the Intervention|"The change between subjects referred to an indicated IPG will be measured after the intervention in total number of patients that are referred correctly.~Because the study intervention was not conducted, it is not possible to compare the proportion of subjects receiving therapy referral for an indicated IPG pre-intervention (Phase I) to the proportion post-intervention (Phase II). Instead, the proportion of SND subjects receiving a referral for an indicated IPG device in Phase I are reported."|3, 6, and 15 months|Because the study intervention was not conducted, it is not possible to compare the proportion of subjects receiving indicated therapy pre-intervention (Phase I) to the proportion post-intervention (Phase II). Instead, the proportion of SND subjects receiving indicated IPG therapy in Phase I are reported|||Participants|||Count of Participants
2543531|NCT02976181|Primary|Absolute Change in the Proportion of Subjects Diagnosed With SND at Pre Specific Time.|Because the study intervention was not conducted, it is not possible to compare the proportion of subjects with an SND diagnosis pre-intervention (Phase I) to the proportion post-intervention (Phase II). Instead, the proportion of subjects with an SND diagnosis in Phase I are reported|6 and 12 months|Number of SND Diagnoses by Time to Diagnosis|||Participants|||Count of Participants
2543532|NCT02976103|Secondary|Patient-Reported Usage of Jacki Recovery Jacket (Daily Diary)|Self-reported proportion of days in the first 7 days post-discharge that participant wore the Jacki recovery jacket at all; no score is better or worse|1-2 weeks|Summary measure for participants in the Jacki Recovery Jacket + Standard Care arm only. A proportion score was calculated if the measure was reported for at least 5 of the first 7 days post-discharge. Of 73 participants assigned to this arm, 53 returned a T2 diary, and 49 had sufficient data to calculate a proportion score.|||Proportion of days||Inter-Quartile Range|Median
2543533|NCT02976103|Secondary|Pain Management At Home: Use of Mastectomy Camisole (Daily Diary)|Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy camisole (if at least 5 days reported)|1-2 weeks|Participants who returned a T2 diary with sufficient data on wearing a mastectomy camisole to calculate a proportion for the first 7 days post-discharge|||Proportion of days||Inter-Quartile Range|Median
2543534|NCT02976103|Secondary|Pain Management At Home: Use of Mastectomy Bra (Daily Diary)|Self-reported proportion of days in the first 7 days post discharge that participant wore a mastectomy bra (if at least 5 days reported)|1-2 weeks|Participants who returned a T2 diary with sufficient data on wearing a mastectomy bra to calculate a proportion for the first 7 days post-discharge|||Proportion of days||Inter-Quartile Range|Median
2543535|NCT02976103|Secondary|Pain Management At Home: Use of Pain Medication (Daily Diary)|Participant self-report of average daily morphine eqivalent dose taken in first 7 days post-discharge (if at least 5 days reported)|1-2 weeks|Participants who returned T2 diary with sufficient information on medication usage to calculate a 7-day average morphine equivalent dose|||morphine equivalent dose units||Inter-Quartile Range|Median
2543536|NCT02976103|Secondary|Pain Patterns At Home: Average Daily Pain Intensity (Daily Diary)|Average 0-10 Pain Intensity Numeric Scale Rating, for 7 days post-discharge, if at least 5 days reported (T2 diary)|1 week|16 in Jacki arm and 21 in Standard Care arm did not return T2 diary; 2 in Standard Care arm returned diary with missing data, for a total of 23 missing this measure in Standard Care arm|||units on a scale||Inter-Quartile Range|Median
2543537|NCT02976103|Secondary|EORTC QLQ-BR23: Upset by Hair Loss Subscale|1 item (range 0-100); higher score = worse outcome|1-2 weeks|Most participants did not answer this item as they had not experienced hair loss (did not receive chemotherapy prior to surgery)|||score on a scale||Standard Deviation|Mean
2543538|NCT02976103|Secondary|EORTC QLQ-BR23: Arm Symptoms Subscale|3 items (range 0-100); higher score = worse outcome|1-2 weeks||||score on a scale||Standard Deviation|Mean
2543539|NCT02976103|Secondary|EORTC QLQ-BR23: Breast Symptoms Subscale|4 items (range 0-100); higher score = worse outcome|1-2 weeks||||score on a scale||Standard Deviation|Mean
2543540|NCT02976103|Secondary|EORTC QLQ-BR23: Systemic Therapy Side Effects Subscale|7 items (range 0-100); higher score = worse outcome|1-2 weeks||||score on a scale||Standard Deviation|Mean
2543541|NCT02976103|Secondary|EORTC QLQ-BR23: Future Perspective Subscale|1 item (range 0-100); higher score = worse outcome|1-2 weeks||||score on a scale||Standard Deviation|Mean
2543542|NCT02976103|Secondary|EORTC QLQ-BR23: Sexual Enjoyment Subscale|1 item (range 0-100); higher score = better outcome|1-2 weeks|The majority of respondents skipped this item because they were not sexually active in the time period immediately after surgery|||score on a scale||Standard Deviation|Mean
2543543|NCT02976103|Secondary|EORTC QLQ-BR23: Sexual Functioning Subscale|2 items (range 0-100); higher score = better outcome|1-2 weeks||||score on a scale||Standard Deviation|Mean
2543544|NCT02976103|Secondary|EORTC QLQ-BR23: Body Image Subscale|4 items (score 0-100); higher score = worse outcome|1-2 weeks||||score on a scale||Standard Deviation|Mean
2543554|NCT02976103|Secondary|Symptom Distress Scale - Pain Frequency|1 item (score range 1-5); higher score = worse outcome|1-2 weeks|13 participants in the standard care arm and 8 in the Jacki Jacket arm (total of 21) did not answer the T3 questionnaire or did not answer this item|||score on a scale||Standard Deviation|Mean
2543555|NCT02976103|Primary|Pain Intensity (on the 0-10 Pain Intensity Numeric Scale)|Pain Intensity Numeric Scale (0-10)(higher scores = worse outcome)|1-2 weeks|Standard Care arm (n=54): 52 of 54 participants who answered T3 with a PINS score, plus 2 participants who answered for the same day in their T2 diary Jacki+Standard Care arm (n=68): 64 of 64 participants who answered T3 with a PINS score, plus 4 participants who answered for the same day in their T2 diary|||score on a scale||Standard Deviation|Mean
2543556|NCT02975804|Secondary|Gross Motor Function Measure 88- Standing|assess the gross motor function in standing position using Gross Motor Function Measure 88-standing (score ranged from 0 to 39) where higher score means higher gross motor function in this position.|12 weeks|This outcome has been abandoned as it was decided to use a concise version of Gross Motor Function Measure Item Set to avoid over-burdening of the study participants.||||||
2543557|NCT02975804|Secondary|Gross Motor Function Measure 88- Crawling and Kneeling|assess the gross motor function in crawling position using Gross Motor Function Measure 88-crawling and kneeling (score ranged from 0 to 42) where higher score means higher gross motor function in this position.|12 weeks|This outcome has been abandoned as it was decided to use a concise version of Gross Motor Function Measure Item Set to avoid over-burdening of the study participants.||||||
2543558|NCT02975804|Secondary|Gross Motor Function Measure 88- Sitting|assess the gross motor function inlsitting using Gross Motor Function Measure 88-sitting (score ranged from 0 to 60) where higher score means higher gross motor function in this position.|12 weeks|This outcome has been abandoned as it was decided to use a concise version of Gross Motor Function Measure Item Set to avoid over-burdening of the study participants.||||||
2543559|NCT02975804|Secondary|Gross Motor Function Measure 88- Lying|assess the gross motor function in lying and rolling using Gross Motor Function Measure 88-lying (score ranged from 0 to 51) where higher score means higher gross motor function in this position.|12 weeks|This outcome has been abandoned as it was decided to use a concise version of Gross Motor Function Measure Item Set to avoid over-burdening of the study participants.||||||
2543560|NCT02975804|Secondary|Weight|measure the body weight of study participants in kilograms|12 weeks|Data was not collected in the study as it was determined that measurement of weight was not related to any of the primary outcomes. To cut down this outcome measure could also reduce the unnecessary measurement burden on the study participants.||||||
2543561|NCT02975804|Secondary|Height|measure the height of study participants in centimetres|12 weeks|Data was not collected in the study as it was determined that measurement of height was not related to any of the primary outcomes. To cut down this outcome measure could also reduce the unnecessary measurement burden on the study participants.||||||
2543562|NCT02975804|Secondary|2-minute Walk Test|measure how far the study participant can walk in 2 minutes in metres|12 weeks||||meters||Standard Deviation|Mean
2543563|NCT02975804|Secondary|Gross Motor Function Measure Item Set- Total Score|assess the gross motor function using Gross Motor Function Measure Item Set.There are 4 Item Sets: Item Set 1 includes 15 test items (score ranged from 0 to 45), Item Set 2 including 29 items (score ranged from 0 to 87), Item Set 3 including 39 items (score ranged from 0 to 117) and Item Set 4 including 22 test items (score ranged from 0 to 66). Each participant will only be assessed with 1 Item Set based on their score on pre-defined decision items (Russell et al.Gross Motor Function Measure (GMFM-66 & GMFM-88) User's manual 2nd Edition. 2013). Individual item scores of the Item Set are entered and a mathematical algorithm calculates an interval level total score ranged from 0 to 100) using the Gross Motor Ability Estimator (GMAE-2) Scoring Software (https://www.canchild.ca/en/resources/191-gross-motor-ability-estimator-gmae-2-scoring-software-for-the-gmfm). The higher scores mean higher abilities.|12 weeks||||score on a scale||Standard Deviation|Mean
2543564|NCT02975804|Secondary|Pediatric Reach Test- Left Standing|assess how far the child can reach to his/her left in standing|12 weeks|This outcome measure was abandoned as all the participants were unable to stand unaided long enough to complete the measurement.||||||
2543565|NCT02975804|Secondary|Pediatric Reach Test- Right Standing|assess how far the child can reach to his/her right in standing|12 weeks|This outcome measure was abandoned as all the participants were unable to stand unaided long enough to complete the measurement.||||||
2543566|NCT02975804|Secondary|Pediatric Reach Test- Forward Standing|assess how far the child can reach forward in standing|12 weeks|This outcome measure was abandoned as all the participants were unable to stand unaided long enough to complete the measurement.||||||
2543567|NCT02975804|Secondary|Pediatric Reach Test- Left Sitting|assess how far the child can reach to his/her left in sitting|12 weeks||||centimeters||Standard Deviation|Mean
2543568|NCT02975804|Secondary|Pediatric Reach Test- Right Sitting|assess how far the child can reach to his/her right in sitting|12 weeks||||centimeters||Standard Deviation|Mean
2543569|NCT02975804|Secondary|Pediatric Reach Test-forward Sitting|assess how far the child can reach forward in sitting|12 weeks||||centimeters||Standard Deviation|Mean
2543570|NCT02975804|Primary|Segmental Assessment on Trunk Control-reactive|assess the level of reactive segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.|12 weeks||||score on a scale||Full Range|Median
2543571|NCT02975804|Primary|Segmental Assessment on Trunk Control-active|assess the level of active segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.|12 weeks||||score on a scale||Full Range|Median
2543572|NCT02975804|Primary|Segmental Assessment on Trunk Control-static|assess the level of static segmental trunk control. Assessment score represents as follows: 1= learning head control, 2= learning upper thoracic control, 3= learning mid-thoracic control, 4= learning lower thoracic control, 5= learning at upper lumber control, 6= learning lower lumbar control, 7= learning full trunk control and 8= achieved full trunk control.|12 weeks||||score on a scale||Full Range|Median
2543573|NCT02975700|Secondary|Summary of Drug-related Treatment-emergent Adverse Events Grade ≥ 3 Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma|Grade ≥ 3 was used to indicate moderate-to-severe treatment-emergent adverse events in which moderate was defined as discomfort enough to cause interference with normal daily activities and severe defined as the inability to perform normal daily activities.|within 28 days after administration of the last dose of study drug, up to 18 months postdose|Safety events were assessed in the Safety Analysis Set.|||Participants|||Count of Participants
2543574|NCT02975700|Secondary|Summary of Most Common (≥50%) Drug-related Treatment-emergent Adverse Events Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma||within 28 days after administration of the last dose of study drug, up to 18 months postdose|Safety events were assessed in the Safety Analysis Set.|||Participants|||Count of Participants
2543575|NCT02975700|Secondary|Summary of Treatment-emergent Adverse Events Grade ≥ 3 Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma|Grade ≥ 3 was used to indicate moderate-to-severe treatment-emergent adverse events in which moderate was defined as discomfort enough to cause interference with normal daily activities and severe defined as the inability to perform normal daily activities.|within 28 days after administration of the last dose of study drug, up to 18 months postdose|Safety events were assessed in the Safety Analysis Set.|||Participants|||Count of Participants
2543576|NCT02975700|Secondary|Summary of Most Common (≥50% of Participants) Treatment-emergent Adverse Events Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma||within 28 days after administration of the last dose of study drug, up to 18 months postdose|Safety events were assessed in the Safety Analysis Set.|||Participants|||Count of Participants
2543577|NCT02975700|Secondary|Summary of Pharmacokinetic Parameter of Accumulation Ratio of Day 15 to Day 1 for Cmax (Rcmax) of PL3397 at Day 15 Following Twice Daily Administration of PL3397 at 1000 mg/Day in Participants With Unresectable or Advanced KIT-mutated Melanoma||Cycle 1, Day 1 and Day 15 at predose, 0.5 h, 1h, 2h, 4h, and 6h postdose|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||Ratio||Standard Deviation|Mean
2543578|NCT02975700|Secondary|Summary of Pharmacokinetic Parameter of Accumulation Ratio of Day 15 to Day 1 for AUC0-6h (Robs) of PL3397 at Day 15 Following Twice Daily Administration of PL3397 at 1000 mg/Day in Participants With Unresectable or Advanced KIT-mutated Melanoma||Cycle 1, Day 1 and Day 15 at predose, 0.5 h, 1h, 2h, 4h, and 6h postdose|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||Ratio||Standard Deviation|Mean
2543579|NCT02975700|Secondary|Summary of Pharmacokinetic Parameter of Time to Maximum Concentration and Last Measurable Time of PL3397 at Days 1 and 15 Following Twice Daily Administration of PL3397 at 1000 mg/Day in Participants With Unresectable or Advanced KIT-mutated Melanoma||Cycle 1, Day 1 and Day 15 at predose, 0.5 h, 1h, 2h, 4h, and 6h postdose|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||hours||Standard Deviation|Mean
2543580|NCT02975700|Secondary|Summary of Pharmacokinetic Parameter of Area Under the Curve From Zero to 6 Hours (AUC0-6) of PL3397 at Days 1 and 15 Following Twice Daily Administration of PL3397 at 1000 mg/Day in Participants With Unresectable or Advanced KIT-mutated Melanoma||Cycle 1, Day 1 and Day 15 at predose, 0.5 h, 1h, 2h, 4h, and 6h postdose|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||h*ng/mL||Standard Deviation|Mean
2543581|NCT02975700|Secondary|Summary of Pharmacokinetic Parameter of Maximum Concentration (Cmax) of PL3397 at Days 1 and 15 Following Twice Daily Administration of PL3397 at 1000 mg/Day in Participants With Unresectable or Advanced KIT-mutated Melanoma||Cycle 1, Day 1 and Day 15 at predose, 0.5 h, 1h, 2h, 4h, and 6h postdose|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||ng/mL||Standard Deviation|Mean
2543582|NCT02975700|Secondary|Disease Control Rate Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma|Disease control rate (DCR) was defined as the percentage of participants who had achieved complete response (CR), partial response (PR), or stable disease (SD).|within 18 months postdose|Disease control rate among participants who achieved CR, PR, or SD was assessed in the Modified Intent-to-Treat Analysis Set.|||Participants|||Count of Participants
2543583|NCT02975700|Secondary|Overall Survival Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma|Overall survival (OS) was defined as the time from study enrollment to death from any cause, censoring at the date of last contact or the end of the study.|within 18 months postdose|Overall survival was assessed in the Modified Intent-to-Treat Analysis Set.|||months||95% Confidence Interval|Median
2543584|NCT02975700|Secondary|Progression-free Survival Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma|Progression-free survival (PFS) was to be calculated for each participant as the number of days from study enrollment to the date of the first documented disease progression or date of death from any cause, whichever occurred first.|within 18 months postdose|Progression-free survival was assessed in the Modified Intent-to-Treat Analysis Set.|||months||95% Confidence Interval|Median
2543585|NCT02975700|Secondary|Duration of Response Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma|Duration of Response (DoR) was defined as the time from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the first documentation of disease progression or to death due to any cause, whichever occurred first. DoR was to only be calculated for the subgroup of participants with an objective tumor response.|within 18 months postdose|Duration of response was assessed in the Modified Intent-to-Treat Analysis Set.|||months||Full Range|Median
2543586|NCT02975700|Primary|Objective Response Rate (ORR) Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma|Objective response rate was defined as complete response (CR) or partial response (PR).|within 18 months postdose|Objective response rate among participants who achieved complete response or partial response was assessed in the Modified Intent-to-Treat Analysis Set.|||Participants|||Count of Participants
2543768|NCT02970552|Secondary|Ascertainment of Date of Delivery and Infant Vital Status|Number of women for whom date of delivery and infant vital status at birth was ascertained|Visit 10.0 (Delivery)|All enrolled participants|||Participants|||Count of Participants
2543587|NCT02975700|Primary|Summary of Best Overall Response Following Twice Daily Administration of PL3397 at 1000 mg/Day In Participants With Unresectable or Advanced KIT-mutated Melanoma|For the assessment of best overall response, participants were classified by RECIST v1.1: complete response (CR), disappearance of all target lesions and normalization of tumor marker level; partial response (PR), at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; stable disease (SD); neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study; progressive disease (PD), at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm; or not evaluable (NE) for analysis.|within 18 months postdose|Best overall response was assessed in the Modified Intent-to-Treat Analysis Set.|||Participants|||Count of Participants
2543588|NCT02975557|Primary|Primary Tolerability End Point: The Test Substance Tolerance (Visual Analog Scale) at 12 Weeks.|"Subjects assessed their tolerance to the administration of the study drug, utilizing a Visual Analog Scale (VAS). The VAS is a 100 mm horizontal line with verbal descriptors at either end and marks at an equal distance starting from 0 mm and leading up to 100 mm (0 10 20 30 40 50 60 70 80 90 100). The VAS ratings will be completed after administration of the study drug on Day 1 (post-dose), week 3, week 6, week 9 and week 12. Subjects will place a single slash mark across the horizontal line between the end labeled completely intolerable (0 mm) and easily tolerable (100mm)."|12 weeks|The sponsor terminated the research early citing slow accrual of subjects and ceased sponsorship. At this point, the available valid sample size was 11 subjects at 12 weeks for assessing the tolerability at 12 weeks.|||Participants|||Count of Participants
2543589|NCT02975206|Secondary|Change in Quality of Life (ItchyQoL) From Baseline to Week 6|ItchyQoL is a 22-item pruritus-specific instrument that measures the degree to which pruritus affects quality-of-life. The responses to the items are Never (1), Rarely (2), Sometimes (3), Often (4) and All the Time (5). A higher score corresponds to a more adverse impact. The overall score is the average of the 22 items ranging from 1 to 5.|Week 6 compared to Baseline|These figures represent all participants in the full analysis set who completed the ItchyQol assessment at both Baseline and Week 6.|||score on a scale||Standard Deviation|Mean
2543590|NCT02975206|Secondary|WI-NRS 4-point Responder Rate at Week 6|Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. A 4-point responder is a subject who had at least a 4-point reduction in score between Week 6 and baseline.|Week 6 compared to Baseline|These figures represent full analysis set.|||Participants|||Count of Participants
2543591|NCT02975206|Primary|Change in WI-NRS From Baseline to Week 6|Worst Itch Numeric Rating Scale (WI-NRS). 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). Higher scores indicate greater itch intensity. The primary outcome is the change in WI-NRS score between the visit and Baseline.|Week 6 compared to Baseline|These figures represent full analysis set.|||score on a scale||Standard Deviation|Mean
2543592|NCT02974855|Secondary|Number of Participants Who Tested Positive for Neutralizing Antibody (NAb)|Human plasma NAb samples were analyzed for the presence or absence of NAb to PF-06741086 using semi-quantitative electrochemiluminescence (ECL) method. Treatment induced are negative prior to dosing and become positive during/after dosing. Treatment boosted are positive prior to dosing but titer increases during/after dosing.|Baseline up to Study Day 113|Only positive ADA samples and the corresponding baseline sample were tested in the NAb assay.|||Participants|||Count of Participants
2543593|NCT02974855|Secondary|Number of Participants Who Tested Positive for Anti-PF-06741086 Antibody (ADA)|Human plasma ADA samples were analyzed for the detection of anti PF-06741086 antibodies by using semi-quantitative electrochemiluminescence (ECL) method. The criterion for positive result of ADA samples was ADA titer >=1.53. Treatment induced are negative prior to dosing and become positive during/after dosing. Treatment boosted are positive prior to dosing but titer increases during/after dosing.|Baseline up to Study Day 113|This analysis population included all participants who received at least 1 dose of investigational drug.|||Participants|||Count of Participants
2543594|NCT02974855|Secondary|Change From Baseline in Dilute Prothrombin Time|An ex vivo pharmacodynamic measure of thrombin generation (via extrinsic pathway). Clotting time is measured using a dilute prothrombin time reagent consisting of a unique formulation of relipidated recombinant tissue factor and calcium.|Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113|The analysis population included all enrolled participants who received at least 1 dose of study medication and had a baseline measurement and at least 1 post-dose measurement for at least 1 pharmacodynamic endpoint.|||seconds||Standard Deviation|Mean
2543595|NCT02974855|Secondary|Change From Baseline in D-Dimer|An in vivo pharmacodynamic measure of thrombin generation (fibrin degradation). D-dimer is a fibrin degradation product, a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis. D-dimer is one of the protein fragments produced when a blood clot gets dissolved in the body. It is normally undetectable or detectable at a very low level unless the body is forming and breaking down blood clots. Then, its level in the blood can significantly rise.|Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113|The analysis population included all enrolled participants who received at least 1 dose of study medication and had a baseline measurement and at least 1 post-dose measurement for at least 1 pharmacodynamic endpoint.|||microgram/milliliter||Standard Deviation|Mean
2543596|NCT02974855|Secondary|Change From Baseline in Prothrombin Fragments 1 + 2|An in vivo pharmacodynamic measure of thrombin generation (prothrombin cleavage). Prothrombin fragment 1+2 (F 1+2) is the amino terminus fragment of the prothrombin molecule. It is a polypeptide with a half-life of approximately 90 minutes. F 1+2 is released from prothrombin when prothrombin is converted to thrombin by the prothrombinase complex.|Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113|The analysis population included all enrolled participants who received at least 1 dose of study medication and had a baseline measurement and at least 1 post-dose measurement for at least 1 pharmacodynamic endpoint.|||picomole/liter||Standard Deviation|Mean
2543618|NCT02974855|Primary|Change From Baseline for Globulin by Dose Cohort|Blood samples were obtained to determine globulin level in serum, total globulin was derived as total protein other than albumin.|Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number analyzed refers to number of participants evaluable for specified rows of time points.|||gram/liter||Standard Deviation|Mean
2543597|NCT02974855|Secondary|Change From Baseline in Endogenous Thrombin Generation (TGA) Potential|An ex vivo pharmacodynamic measure of thrombin generation. The endogenous TGA potential represents the total amount of active thrombin formed during thrombin generation and the peak height the maximal amount of thrombin formed.|Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113|The analysis population included all enrolled participants who received at least 1 dose of study medication and had a baseline measurement and at least 1 post-dose measurement for at least 1 pharmacodynamic endpoint.|||nanomole*minute||Standard Deviation|Mean
2543598|NCT02974855|Secondary|Change From Baseline in Thrombin Generation (TGA) Peak|An ex vivo pharmacodynamic measure of thrombin generation (initiation of thrombin generation). The peak represents the highest thrombin concentration that can be generated. There may be patients who reach the peak faster or slower than others and this may represent hyper- or hypocoagulability, respectively.|Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113|The analysis population included all enrolled participants who received at least 1 dose of study medication and had a baseline measurement and at least 1 post-dose measurement for at least 1 pharmacodynamic endpoint.|||nanomole||Standard Deviation|Mean
2543599|NCT02974855|Secondary|Change From Baseline in Thrombin Generation (TGA) Lag Time|An ex vivo pharmacodynamic measure of thrombin generation (initiation of thrombin generation), the lag time is the time needed to form the first traces of thrombin.|Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113|The analysis population included all enrolled participants who received at least 1 dose of study medication and had a baseline measurement and at least 1 post-dose measurement for at least 1 pharmacodynamic endpoint.|||minutes||Standard Deviation|Mean
2543600|NCT02974855|Secondary|Change From Baseline in Total Tissue Factor Pathway Inhibitor (TFPI)|Total amount of tissue factor pathway inhibitor (TFPI) (bound and unbound) in plasma. TFPI is a protease inhibitor which acts as an antagonist of the extrinsic coagulation pathway via inhibition of tissue factor activated coagulation factor VII (FVIIa) and activated factor X (FXa). Human plasma samples were analyzed for total TFPI concentrations using a validated, sensitive and specific high-performance liquid chromatography tandem mass spectrometric method (LC-MS/MS). Mixed model repeated measures (MMRM) was used to analyze the change from baseline on TFPI.|Baseline, Study Day 2, 4, 8, 15, 22, 29, 30, 33, 57, 85 and 113|The analysis population included all enrolled participants who received at least 1 dose of study medication and had a baseline measurement and at least 1 post-dose measurement for at least 1 pharmacodynamic endpoint.|||nanogram/milliliter||Standard Deviation|Mean
2543601|NCT02974855|Secondary|Apparent Clearance After Oral Dose (CL/F) of PF-06741086|CL/F was calculated by dose/AUCtau.|Pre-dose on Day 29, 24 and 96 hours post Day 29 dosing|The PK parameter analysis population included all enrolled participants treated who had at least 1 quantifiable concentration and in whom at least 1 of the PK parameters of interest was calculated.|||milliliter/hour||Geometric Coefficient of Variation|Geometric Mean
2543602|NCT02974855|Secondary|Area Under the Serum Concentration-time Curve Over the Dosing Interval Tau (AUCtau) of PF-06741086|The dosing interval tau was 1 week. AUCtau was obtained by linear/log trapezoidal method.|Pre-dose on Day 29, 24 and 96 hours post Day 29 dosing|The PK parameter analysis population included all enrolled participants treated who had at least 1 quantifiable concentration and in whom at least 1 of the PK parameters of interest was calculated.|||nanogram*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
2543603|NCT02974855|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of PF-06741086|Tmax was observed directly from data as time of first occurrence.|Pre-dose on Day 1, 24 and 96 hours post Day 1 dosing, pre-dose on Day 29, 24 and 96 hours post Day 29 dosing|The PK parameter analysis population included all enrolled participants treated who had at least 1 quantifiable concentration. Number analyzed refers to number of participants evaluable for specified rows.|||hours||Full Range|Median
2543604|NCT02974855|Secondary|Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06741086|Cmin was observed directly from data.|Pre-dose on Day 1, 24 and 96 hours post Day 1 dosing, pre-dose on Day 29, 24 and 96 hours post Day 29 dosing|The PK parameter analysis population included all enrolled participants treated who had at least 1 quantifiable concentration. Number analyzed refers to number of participants evaluable for specified rows.|||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2543605|NCT02974855|Secondary|Maximum Plasma Concentration (Cmax) of PF-06741086|Cmax was observed directly from data.|Pre-dose on Day 1, 24 and 96 hours post Day 1 dosing, pre-dose on Day 29, 24 and 96 hours post Day 29 dosing|The PK parameter analysis population included all enrolled participants treated who had at least 1 quantifiable concentration. Number analyzed refers to number of participants evaluable for specified rows.|||nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2543606|NCT02974855|Secondary|Area Under the Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-06741086|AUClast was calculated by linear/Log trapezoidal method.|Pre-dose on Day 1, 24 and 96 hours post Day 1 dosing|The PK parameter analysis population included all enrolled participants treated who had at least 1 quantifiable concentration.|||nanogram*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
2543607|NCT02974855|Secondary|Plasma PF-06741086 Concentrations|Plasma PF-06741086 concentrations were analyzed using a validated, sensitive and specific electrochemiluminescence (ECL) method.|pre-dose on Study Day 1, 24hours (h), 72h post Study Day 1 dosing, pre-dose on Study Day 8, 15 and 22, pre-dose on Study Day 29, 24h, 96h post Study Day 29 dosing, pre-dose on Study Day 57, 168h, 840h post Study Day 57 dosing|The PK concentration population included all enrolled participants treated who had at least 1 quantifiable concentration. Number analyzed refers to number of participants evaluable for specified rows of categories.|||nanogram/milliliter||Standard Deviation|Mean
2543619|NCT02974855|Primary|Number of Participants With Abnormal Laboratory Findings-Urinalysis|Urinalysis included: pH, urine glucose, ketones, urine protein, urine hemoglobin, urobilinogen, urine bilirubin, nitrite, leukocyte esterase, urine erythrocytes, urine leukocytes and bacteria.|Baseline to Study Day 113 Visit|This analysis population included all participants who received at least 1 dose of investigational product. Number analyzed refers to number of participants evaluable for specified rows.|||Participants|||Count of Participants
2543647|NCT02973802|Secondary|Change From Baseline in IL-10 mRNA Expression in PBMCs||weeks 0, 18 and 22|No clear treatment effects could be determined possibly due to technical issues with the preparation and assay of the PBMCs. In addition, the 2 week post dose time point of blood sampling, meant that the induced Treg cells or cytokine changes were no longer detectable in peripheral blood.||||||
2543608|NCT02974855|Secondary|Annualized Bleeding Rate (ABR)|Pre-treatment ABR = number of bleeding episodes within 6 months prior to study enrollment (total number of bleeding episodes in hemophilia history CRF) × 2; On-study ABR = number of bleeding episodes occurred within 9 days after the last dose / ([last dose date + 9 - first dose date + 1] / 365.25) The historical On Demand group was constructed using the following internal Pfizer studies: ReFacto AF 3082B2-4432 (B1831004), BeneFIX B1821010, and BeneFIX 3090A1-400 (B1821004). Participants who were on On Demand treatment in B1831004, as well as data from the On Demand period in B1821004 and B1821010 were used to construct the historical On Demand group. The resulting dataset were further filtered to match the key inclusion/exclusion criteria of Study B7841002 based on age and factor activity (18 <=age <=65 and factor activity <=1%).|Pre-treatment: within 6 months prior to study enrollment; On-study: Day 1 to 9 days after the last dose (Day 78)|This efficacy analysis was conducted in the Per Protocol Analysis Set (PPAS) that included all participants who received at least 1 dose of investigational product and did not have any major protocol deviations.|||Bleeding episodes per year||Standard Deviation|Mean
2543609|NCT02974855|Primary|Number of Participants With Infusion and Injection Site Reactions|Infusion and injection site reactions included: injection site bruising, injection site erythema, injection site haemorrhage, injection site induration, injection site pain, injection site pruritus, injection site swelling and injection site warmth. Grade of severity was defined as follows: Mild: Transient or mild discomfort (< 48 hours); no medical intervention/therapy required. Moderate: Mild to moderate limitation in activity - some assistance may be needed; no or minimal medical intervention/therapy required. Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalizations possible.|Baseline to Study Day 113 Visit|This analysis population included all participants who received at least 1 dose of investigational product.|||Participants|||Count of Participants
2543610|NCT02974855|Primary|Number of Participants With Clinically Significant Changes in Physical Examination Findings|Physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Clinical significance was judged by the investigator.|Baseline to Study Day 113 Visit|This analysis population included all participants who received at least 1 dose of investigational product.|||Participants|||Count of Participants
2543611|NCT02974855|Primary|Number of Participants With Electrocardiogram (ECG) Change Meeting Pre-specified Criteria|Criteria for potentially clinically important changes in ECG were defined as: PR interval baseline >200 msec and increase of >=25%; PR interval baseline <=200 msec and increase of >=50%; QRS interval increase of >=50%. Only the number of participants meeting pre-defined criteria was reported below.|Baseline to Study Day 29 Visit.|This analysis population included all participants who received at least 1 dose of investigational product.|||Participants|||Count of Participants
2543612|NCT02974855|Primary|Number of Participants With Vital Signs Data Meeting Pre-specified Criteria|Criteria for potentially clinically important findings in vital signs data were defined as: 1) supine systolic blood pressure (BP): value <90 mm Hg or change >=30 mm Hg increase; 2) Supine diastolic BP: value <50 mm Hg or change >=20 mm Hg increase; 3) Supine pulse rate: value <40 beats/min or >120 beats/min.|Baseline to Study Day 113 Visit|This analysis population included all participants who received at least 1 dose of investigational product.|||Participants|||Count of Participants
2543613|NCT02974855|Primary|Change From Baseline for Troponin I by Dose Cohort|Blood samples were collected to measure the level of cardiac-specific troponin I in the blood to help detect heart injury.|Baseline, Study Day 8, 15, 22, 29, 57 and 85.|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number analyzed refers to number of participants evaluable for specified rows of time points.|||nanogram/milliliter||Standard Deviation|Mean
2543614|NCT02974855|Primary|Change From Baseline for Antithrombin III by Dose Cohort|Antithrombin (AT) is a protein produced by the liver that helps regulate blood clot formation (i.e., a naturally-occurring mild blood thinner). Blood samples were collected to measure the activity (function) and the amount (quantity) of antithrombin in an individual's blood is used to evaluate the person for excessive blood clotting.|Baseline, Study Day 8, 15, 22 and 29.|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number analyzed refers to number of participants evaluable for specified rows of time points.|||Percentage of activity of AT in plasma||Standard Deviation|Mean
2543615|NCT02974855|Primary|Change From Baseline for Fibrinogen by Dose Cohort|Fibrinogen is a protein, specifically a clotting factor (factor I), that is essential for proper blood clot formation. Blood samples were obtained to evaluate the amount of fibrinogen.|Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number analyzed refers to number of participants evaluable for specified rows of time points.|||milligram/deciliter||Standard Deviation|Mean
2543616|NCT02974855|Primary|Change From Baseline for Activated Partial Thromboplastin Time (aPTT) by Dose Cohort|The activated partial thromboplastin time (aPTT) is a screening test that helps evaluate a person's ability to appropriately form blood clots. It measures the number of seconds it takes for a clot to form in a sample of blood after substances (reagents) are added. Blood sample were obtained to evaluate aPTT.|Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number analyzed refers to number of participants evaluable for specified rows of time points.|||seconds||Standard Deviation|Mean
2543617|NCT02974855|Primary|Change From Baseline for Prothrombin International Normalized Ratio (PT/INR) by Dose Cohort|Blood samples were obtained to evaluate this ratio. The prothrombin time (PT) is a test that helps evaluate your ability to appropriately form blood clots. The international normalized ratio (INR) is a calculation based on results of a PT that is used to monitor individuals who are being treated with the blood-thinning medication (anticoagulant) warfarin (Coumadin®).|Baseline, Study Day 8, 15, 22, 29, 57, 85 and 113.|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number analyzed refers to number of participants evaluable for specified rows of time points.|||Ratio||Standard Deviation|Mean
2543644|NCT02974088|Secondary|Difference in Number of Participants Free From Head Louse Infestation According to Comb Type Used|It was expected that the louse comb group would show a high level of success (elimination of infestation). The measure of efficacy of the neem-based lotion was the relative efficacy observed in the grooming comb group compared with the louse comb group|15 days|||||||
2543620|NCT02974855|Primary|Number of Participants With Abnormal Laboratory Findings-Clinical Chemistry|Clinical chemistry evaluation included bilirubin, direct and indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, troponin I, cholesterol and fibrinogen.|Baseline to Study Day 113|This analysis population included all participants who received at least 1 dose of investigational product. Number analyzed refers to number of participants evaluable for specified rows.|||Participants|||Count of Participants
2543621|NCT02974855|Primary|Number of Participants With Abnormal Laboratory Findings-Hematology|Hematology evaluation included: hemoglobin, hematocrit, erythrocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Predefined criteria for hemoglobin and hematocrit: <0.8*lower limit of normal (LLN) or <0.8*Baseline(Baseline <1.0*LLN); for platelets: <100,000*10^3/mm^3 or <= 0.77*Baseline (Baseline <1.0*LLN).|Baseline to Study Day 113 Visit|This analysis population included all participants who received at least 1 dose of investigational product.|||Participants|||Count of Participants
2543622|NCT02974855|Primary|Number of Participants Discontinued From Study Due to TEAEs|An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.|Study Day 1 to Day 113 Visit|The analysis population included all participants who received at least 1 dose of investigational product.|||Participants|||Count of Participants
2543623|NCT02974855|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Severe TEAEs were TEAEs that interfered significantly with participants' usual function. Treatment-related TEAEs were determined by the investigator.|Study Day 1 to Day 113 Visit|The analysis population included all participants who received at least 1 dose of investigational product.|||Participants|||Count of Participants
2543624|NCT02974842|Primary|Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results.|Cytological evaluations of samples collected from fallopian tubes were performed in a blinded fashion to histology findings from excised fallopian tubes and ovaries. Concordance was evaluated between cytology where collected samples were adequate and available histology.|Up to 60 days post-operatively|Fallopian tubes with adequate samples for cytological evaluation and available surgical histology results.|||fallopian tubes|fallopian tubes||Count of Units
2543625|NCT02974543|Primary|Change in Tinnitus Loudness as Assessed by TinnTester|Change in Tinnitus matching loudness score (mean of weekly assessments for 4 weeks) from baseline tinnitus matching loudness score, for treatment and sham groups. Subjects are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). This measure was performed at baseline, as well as time points following active, washout, or sham periods.|4 weeks on treatment (or sham)|First 3 columns represent the data from same 10 subjects at different time points who participated in the first arm (received active treatment before sham treatment). The last 3 columns represent data from the other 10 subjects at the same timepoints who participated in the 2nd arm (received sham treatment before active treatment).|||dB||Standard Deviation|Mean
2543626|NCT02974543|Primary|Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline|Change in TFI score (mean of weekly assessments for 4 weeks) from baseline for treatment and sham groups. TFI is a clinical questionnaire that assesses tinnitus impact on a subject's quality of life. It uses a scale of 0 - 100 where 0 means no negative impact on quality of life from tinnitus and 100 is devastating impact It will be administered weekly through out the study.|Four weeks on treatment (or sham)|First 3 columns represent the data from same 10 subjects at different time points who participated in the first arm (received active treatment before sham treatment). The last 3 columns represent data from the other 10 subjects at the same timepoints who participated in the 2nd arm (received sham treatment before active treatment).|||units on a scale||Standard Deviation|Mean
2543627|NCT02974140|Secondary|Phaco Aspiration Time Spent During Surgery|Phaco aspiration time (the average time the surgeon took to complete the phacoemulsification) was measured in seconds. A lower value indicates that the surgeon spent less time aspirating fluid and material from the eye during surgery. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.|Day 0 (operative day), each eye|Full Analysis Set with available data|||seconds|Eyes|Standard Deviation|Mean
2543628|NCT02974140|Secondary|Estimated Aspiration Fluid Used During Surgery|Aspiration fluid (amount of fluid used during the removal of the cataractous lens) was measured in milliliters (ml). A lower value indicates less fluid used during the procedure. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.|Day 0 (operative day), each eye|Full Analysis Set with data available|||ml|Eyes|Standard Deviation|Mean
2543629|NCT02974140|Secondary|Cumulative Dissipated Energy (CDE)|Cumulative Dissipated Energy (CDE) represents the energy dissipated of the ultrasound tip and infusion sleeve at the incision point during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was expended in the eye. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.|Day 0 (operative day), each eye|Full Analysis Set with data available|||percent-seconds|Eyes|Standard Deviation|Mean
2543645|NCT02974088|Primary|Number of Participants Free From Head Louse Infestation as Assessed by Detection Combing|Recruitment at Day 0. Success of treatment = No lice present at Day 14 and no lice present at Day 10|15 days|All participants who completed the 15 study days|||Participants|||Count of Participants
2543769|NCT02970552|Secondary|Enrollment of Eligible Participants|Number of eligible participants who enrolled in the study|Screening through Enrollment|Women with a completed ultrasound who were eligible for study screening procedures|||Participants|||Count of Participants
2543630|NCT02974140|Primary|Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1|Manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values were from the manifest refraction assessment. Manifest refraction was assessed at 4 meters under photopic lighting conditions using a phoropter. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.|Day 20-40 from second implantation|Full Analysis Set with data available|||percentage of eyes|Eyes||Number
2543631|NCT02974114|Secondary|Change From Pain-free State (Day 3) in Walking Speed in Pain State (Day 2)|Participants performed a walking assessment in comfortable walking shoes to measure gait parameter walking speed over 5-10m for each foot. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first.|At Day 2 (pre and post-treatment) and Day 3|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||meters/second||Standard Deviation|Mean
2543632|NCT02974114|Secondary|Change From Pain-free State (Day 3) in Stride Length in Pain State (Day 2)|Participants performed a walking assessment in comfortable walking shoes to measure gait parameter stride length. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first.|At Day 2 (pre and post treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||Centimeter||Standard Deviation|Mean
2543633|NCT02974114|Secondary|Change From Pain-free State (Day 3) in Contact Phase in Pain State (Day 2)|Participants performed a walking assessment in comfortable walking shoes to measure gait parameter contact phase. An athletic movement analysis system (Optojump, Microgate) was utilized which set up over a 15 meters (m) length of track with only the 5-10m section measured and analysed. Participants were instructed to walk the 15m length a minimum of 6 times (3 practice and a minimum of 3 test walks) always entering the 15m length with the same foot first. The foot (left or right) entering the 5-10m section first was recorded by visual assessment of the Optojump operator for the test walks. Test walks were repeated until there were 3 walks in which the participants have entered the 5-10m section with the same foot first.|At Day 2 (pre and post treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||Seconds||Full Range|Median
2543634|NCT02974114|Secondary|Change From Pain-free State (Day 3) in Ground Reaction Force (GRF) in Pain State (Day 2)|From a seated position with arms crossed so that the right hand is placed on the left shoulder and the left hand on the right shoulder, participants stood to a fully erect stature in as short a time as possible. Participants conducted the same movement 3-times continuously as a practice effort and 5-times continuously as a test effort at each visit. There was a 1-minute rest between the practice and test effort. GRF was measured during the movement analyzed using a force plate interfaced with a computer.|At Day 2 (pre and post treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||Newtons||Standard Deviation|Mean
2543635|NCT02974114|Secondary|Change From Pain-free State (Day 3) in Time to Standing in Pain State (Day 2)|Time to standing provides a simple assessment of physical mobility. From a seated position with arms crossed so that the right hand is placed on the left shoulder and the left hand on the right shoulder, participants stood to a fully erect stature in as short a time as possible. Time to standing recorded which was measured using a stopwatch. Participants conducted the same movement 3-times continuously as a practice effort and 5-times continuously as a test effort at each visit. There was a 1-minute rest between the practice and test effort.|At Day 2 (pre and post treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||Seconds||Full Range|Median
2543636|NCT02974114|Secondary|Change From Pain-free State (Day 3) in Grip Force in Pain State (Day 2)|This task was a measure of grip strength. The participant held the dynamometer in their dominant hand and the arm was swung from above the head to by the side of the body. If the dominant arm or hand was painful then the non-dominant hand was used. The participant was instructed to assert maximum effort during the squeezing motion and maintain it for about 4 seconds using a metronome. Participant conducted the movement 4-times (1 practice effort and 3 test efforts) and there was a 1-minute recovery period between each effort.|At Day 2 (pre and post-treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||Kilogram (Kg)||Standard Deviation|Mean
2543646|NCT02973802|Secondary|Change From Baseline in Biomarker Signature of PBMC Cells||weeks 0, 18 and 22|No clear treatment effects could be determined possibly due to technical issues with the preparation and assay of the PBMCs. In addition, the 2 week post dose time point of blood sampling, meant that the induced Treg cells or cytokine changes were no longer detectable in peripheral blood.||||||
2543637|NCT02974114|Primary|Change From Pain-free State (Day 3) in Rapid Visual Information Processing A Prime (RVPA) in the Pain State (Day 2)|RVP task was measures of attention. A white box appeared in the centre of the computer screen, inside which digits, from 2 to 9, appeared in a pseudo-random order, at the rate of 100 digits per minute. Participants were requested to detect target sequences of digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the press pad. The RVPA (A prime) was the signal detection measure of sensitivity to the target, regardless of response tendency (the expected range will be 0.00 to 1.00; bad to good). RVP metric was a measure of how good the subject was at detecting target sequences.|At Day 2 (pre and post treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||msec||Full Range|Median
2543638|NCT02974114|Primary|Change From Pain-free State (Day 3) in Spatial Working Memory (SWM) Between Errors in the Pain State (Day 2)|SWM task was a measure of working memory. The task involved number of coloured squares (boxes) being shown on the screen. The aim of this test was to find one blue token in the boxes shown to the participants by process of elimination and used these to fill up an empty column on the right-hand side of the screen. The number of boxes gradually increased up to a maximum of eight boxes to search and the colour and position of the boxes changed from trial to trial. SWM between errors was defined as times the participant revisited a box in which a token has previously been found. This was calculated for trials of four, six and eight tokens.|At Day 2 (pre and post treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||SWM between errors||Standard Deviation|Mean
2543639|NCT02974114|Primary|Change From Pain-free State (Day 3) in Attention Switching Task (AST) Congruency Cost in the Pain State (Day 2)|AST was a measure of executive attention. The test displayed an arrow which can appear on either side of the screen and can point in either direction. Each trial displayed a cue at the top of the screen that indicates whether to press the right or left button. Some trials displayed congruent stimuli (e.g. arrow on the right side of the screen pointing to the right) whereas other trials display incongruent stimuli which require a higher cognitive demand (e.g. arrow on the right side of the screen pointing to the left). The AST congruency cost was the difference between the median latencies of response (from stimulus appearance to button press) on the trials that were congruent versus the trials that were incongruent. It was calculated by subtracting the median of congruent from incongruent latency. A positive score indicated response was faster on congruent trials and a negative score indicated response was faster on incongruent trials.|At Day 2 (pre and post treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||msec||Full Range|Median
2543640|NCT02974114|Primary|Change From Pain-free State (Day 3) in Number of One Touch Stockings (OTS) of Cambridge Assessment Problems (on Which the First Box Choice Made Was Correct) in the Pain State (Day 2)|OTS was a measure of executive function and takes approximately 10 minutes to complete. The participant was shown two displays containing three coloured balls. The displays were presented in such a way that they can easily be perceived as stacks of coloured balls held in stockings or socks suspended from a beam. There was a row of numbered boxes along the bottom of the screen. The test administrator first demonstrated to the participant how to use the balls in the lower display to copy the pattern in the upper display, and completed one demonstration problem, where the solution requires one move. The participant then completed three further problems, one each of two moves, three moves, and four moves. Next, the participant was shown further problems, and participants worked out in their head how many moves the solutions to these problems required, and then touch the appropriate box at the bottom of the screen to indicate their response.|At Day 2 (pre and post treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||OTS of correct first box choice||Standard Deviation|Mean
2543641|NCT02974114|Primary|Change From Pain-free State (Day 3) in Reaction Time in the Pain State (Day 2)|The reaction time of five-choice reaction time task (provided by Cambridge Cognition) was measured. In five-choice reaction time task, all the participants hold down a button at the bottom of the screen till a yellow spot appears in one of the five circles at the top of the screen. Participants then released the button and touch inside of the circle where the yellow spot appeared as quickly as they can. The median duration, between the onset of the stimulus and the release of the button, was recorded as reaction time. Calculated for correct, assessed trials where the stimulus appeared in any one of five locations.|At Day 2 (pre and post-treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||msec||Full Range|Median
2543642|NCT02974114|Primary|Change From Pain Free State (Day 3) in Error Adjusted Simple Reaction Time (SRT) in the Pain State (Day 2)|Error adjusted SRT was one of the main outcomes of the Axon Sports Priming Application. The Axon Sports Priming Application is a computerized test performed on a tablet device that measures cognitive performance, namely psychomotor speed. Axon sports test assessment included 1. Pain-state assessment performed at Visit 2 (Day 2 pre-treatment assessment and post-treatment assessment 1hour [hr] ± 15 minutes [mins] post-dosing) and 2. Pain-free assessment performed at Visit 3 (Day 3).|At Day 2 (pre and post-treatment) and Day 3 of the study|Modified Intent-to-Treat (mITT, N=20) Population: All the participants who were randomized, received at least one dose of the study treatment and had at least one post-baseline assessment without any violation of study inclusion-exclusion criteria were included in the mITT population.|||milliseconds (msec)||Full Range|Median
2543643|NCT02974088|Secondary|Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0|Number of participants with application site reactions|15 days|||||||
2558389|NCT02694549|Primary|Incidence at 30 Days After the Procedure of the Composite Endpoint of Access Site Related Major Adverse Vascular Events (MAVE).||30 days||||Participants|||Count of Participants
2543648|NCT02973802|Secondary|Change From Baseline in Peripheral Blood Mononuclear Cell (PBMC) T Cell Activity||weeks 0, 18 and 22|No clear treatment effects could be determined possibly due to technical issues with the preparation and assay of the PBMCs. In addition, the 2 week post dose time point of blood sampling, meant that the induced Treg cells or cytokine changes were no longer detectable in peripheral blood.||||||
2543649|NCT02973802|Secondary|Change in Serum Thyroid Stimulating Hormone (TSH) From Baseline to Week 22.|Serum TSH was measured centrally from screening to the final week 30 follow-up visit. Baseline was fT4 value at study day 1.|Weeks 18, 22 and 30|The Intention-to-treat population corresponded to all subjects who received at least 1 administration of study drug at any time during the study, irrespective of compliance with eligibility and other protocol|||mIU/L||Standard Deviation|Mean
2543650|NCT02973802|Secondary|Change in Serum Free Thyroxine (T4) From Baseline to Week 22.|Serum fT4 was measured centrally from screening to the final week 30 follow-up visit. Baseline was fT4 value at study day 1.|Weeks 18, 22 and 30|The Intention-to-treat population corresponded to all subjects who received at least 1 administration of study drug at any time during the study, irrespective of compliance with eligibility and other protocol criteria.|||Percent change||Standard Deviation|Mean
2543651|NCT02973802|Secondary|Change in Serum Free Triiodothyronine (fT3) From Baseline to Week 22.|Serum fT3 was measured centrally from screening to the final week 30 follow-up visit. Baseline was fT3 value at study day 1.|Weeks 18, 22 and 30|The Intention-to-treat population corresponded to all subjects who received at least 1 administration of study drug at any time during the study, irrespective of compliance with eligibility and other protocol criteria.|||Percent change||Standard Deviation|Geometric Least Squares Mean
2543652|NCT02973802|Secondary|Change in Serum Anti-TSHR Antibodies From Baseline to Week 22 - Measured by Blocking TSHR Antibodies (TBAb)|"Blocking TSHR antibodies (TBAb) assays were measured using cell-based methods described by Leschik et al.~TBAb activity is measured by calculating percentage inhibition."|Weeks 18, 22 and 30|The Intention-to-treat population corresponded to all subjects who received at least 1 administration of study drug at any time during the study, irrespective of compliance with eligibility and other protocol criteria.|||% Inhibition||Standard Deviation|Mean
2543653|NCT02973802|Secondary|Change in Serum Anti-TSHR Antibodies From Baseline to Week 22 - Measured by Stimulatory TSHR Antibodies (TSAb)|"Stimulatory TSHR antibodies (TSAb) assays were measured using cell-based methods described by Leschik et al.~TSAb activity is measured by calculating percentage specimen-to-reference ratio (%SRR)."|Weeks 18, 22 and 30|The Intention-to-treat population corresponded to all subjects who received at least 1 administration of study drug at any time during the study, irrespective of compliance with eligibility and other protocol criteria.|||%SRR||Standard Deviation|Mean
2543654|NCT02973802|Secondary|Change in Serum Anti-TSHR Antibodies From Baseline to Week 22 - Measured by TSHR-binding Inhibitory Immunoglobulin (TBII)|TSHR-binding inhibitory immunoglobulin (TBII) are autoantibodies directed against the TSH receptor. TBII is used clinically for the differential diagnosis and management of Graves' Disease.|Weeks 18, 22 and 30|The Intention-to-treat population corresponded to all subjects who received at least 1 administration of study drug at any time during the study, irrespective of compliance with eligibility and other protocol criteria.|||IU/L||Standard Deviation|Mean
2543655|NCT02973802|Primary|Occurrence of Treatment Emergent Adverse Events (TEAE), Serious Adverse Events (SAE), and Laboratory Abnormalities up to Week 22 Compared to Baseline.|An adverse event (AE) was defined as any untoward medical occurrence in a subject administered study drug that did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavourable and unintended sign, symptom, disease or outcome of death temporally associated with the use of study drug, whether or not considered causally related to the study drug. Treatment emergent adverse events (TEAEs) were any AE that started or worsened in severity on or after the first administration of study drug up to and including 28 days after the last administration of study drug. Relationship, as indicated by the Investigator, was classified as 'not related', 'possibly related', 'probably related' or 'definitely related' (increasing severity of relationship). A drug related AE was defined as an AE with a relationship to study drug of 'possibly related', 'probably related' or 'definitely related' or with a missing or unknown relationship to study drug|22 weeks|The Intention-to-treat population corresponded to all subjects who received at least 1 administration of study drug at any time during the study, irrespective of compliance with eligibility and other protocol criteria. The Safety population was denoted as the ‘Intention-to-treat population’ for the summarisation of safety endpoints.|||Adverse Events|||Number
2543656|NCT02973100|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 168 Hours (AUC[0-168], ss) of Dulaglutide|AUC[0-168h] is a combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit.|0, 2, 4, 6, 10, 18, 22 weeks and early termination|All randomized participants who received at least one dose of the study drug and have evaluable PK data.|||nanogram*hour per milliliter (ng*h/mL)||90% Confidence Interval|Mean
2543657|NCT02973100|Secondary|Pharmacokinetics (PK): The Maximum Drug Concentration at Steady State (Cmax,ss) of Dulaglutide|Plasma samples for PK analysis were combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit. Cmax takes all time points post dose into account and one value was reported.|0, 2, 4, 6, 10, 18, 22 weeks and early termination|All randomized participants who received at least one dose of the study drug and have evaluable PK data.|||nanogram per milliliter (ng/mL)||90% Confidence Interval|Mean
2543658|NCT02973100|Secondary|Rate of Documented Symptomatic Hypoglycemia|Hypoglycemic events (HE) were classified as severe, documented symptomatic (defined as an HE with typical symptoms of hypoglycemia and a blood glucose level of ≤3.9 millimoles per liter [mmol/L]). Hypoglycemia rate per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia was analyzed using a generalized estimation equations model with a negative binomial distribution and a Log link. LS mean was determined by MMRM methodology with baseline hypoglycemia rate, pooled country, HbA1c at Baseline, treatment, with log of exposure in days divided by 365.25 as the offset.|Week 18|All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue values for hypoglycemic episodes.|||Episodes/participant/365.25 days||Standard Error|Least Squares Mean
2544313|NCT02962960|Secondary|Change From Baseline for Vital Signs|Change from baseline for vital signs.|Baseline to Week 60|Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).|||mmHg||Standard Deviation|Mean
2543659|NCT02973100|Secondary|Percentage of Participants Discontinuing Study Drug Due to Adverse Events|Adverse event (AE) defined as any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.|Baseline through Week 18|All randomized participants who received study drug and had postbaseline data for safety analyses.|||Percentage of Participants|||Number
2543660|NCT02973100|Secondary|Change From Baseline in Body Weight|Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, baseline HbA1c strata using >=8% as cutoff, treatment, time, treatment*time as fixed effects.|Baseline, Week 18|All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue data for body weight.|||Kilograms (Kg)||Standard Error|Least Squares Mean
2543661|NCT02973100|Secondary|Change From Baseline in Fasting Serum Glucose (FSG)|Fasting serum glucose (FSG) is a test to determine how much glucose (sugar) is in a serum sample after an overnight fast. Least Squares (LS) means was determined by MMRM methodology with baseline as a covariate, pooled country, baseline HbA1c strata using >=8% as cutoff, treatment, time, treatment*time as fixed effects.|Baseline, Week 18|All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue data for FSG.|||millimole/liter (mmol/L)||Standard Error|Least Squares Mean
2543662|NCT02973100|Secondary|Percentage of Participants With HbA1c of <7.0%|Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.|Week 18|All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue data for Hemoglobin A1c.|||Percentage of Participants|||Number
2543663|NCT02973100|Primary|Change From Baseline in Hemoglobin A1c (HbA1c)|"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.~Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, treatment, time, treatment*time as fixed effects."|Baseline, Week 18|All randomized participants who received at least one dose of study drug and had postbaseline values, excluding post rescue data for Hemoglobin A1c.|||Percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2543664|NCT02972658|Secondary|Change From Baseline Analysis on the ADAS-Cog13|ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.|AZES Baseline through AZFD Week 52|All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADAS-Cog13 measure.|||Units on a scale||Standard Error|Least Squares Mean
2543665|NCT02972658|Secondary|Change From Baseline on the Mini-Mental Status Examination (MMSE)|The MMSE is an instrument used to assess a participant's cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.|AZES Baseline through AZFD Week 26|All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for MMSE.|||Units on a scale||Standard Error|Least Squares Mean
2543666|NCT02972658|Secondary|Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score|The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.|AZES Baseline through AZFD Week 26|All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for iADRS.|||Units on a scale||Standard Error|Least Squares Mean
2543667|NCT02972658|Secondary|Change From Baseline on the Functional Activities Questionnaire (FAQ) Score|FAQ is a 10-item, caregiver-questionnaire and was administered to the study partner and asked to rate the participant's ability to perform a variety of activities ranging from writing checks, assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now =1; Never did but could do now =0; Normal =0; Has difficulty but does by self =1; Requires assistance =2; Dependent =3). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.|AZES Baseline through AZFD Week 26|All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for FAQ score.|||Units on a scale||Standard Error|Least Squares Mean
2544190|NCT02963935|Secondary|Change in Laboratory Measurements: Biochemistry (Albumin)|Observed mean change from baseline in biochemical parameter - albumin. Results based on SAS on-drug data is presented.|Week 0, week 56|"Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. Number analysed=subjects with available data."|||g/L||Standard Deviation|Mean
2543668|NCT02972658|Secondary|Change From Baseline Analysis on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.|AZES Baseline through AZFD Week 26|All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADCS-iADL measure.|||Units on a scale||Standard Error|Least Squares Mean
2543669|NCT02972658|Primary|Change From Baseline Analysis on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)|ADAS-Cog13 (13-item version of ADAS-Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, age at baseline, and pooled country.|AZES Baseline through AZFD Week 26|All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADAS-Cog13 measure. Feeder study AZES was stopped for futility, the original Delayed Start analysis was replaced with MMRM analysis and no comparisons between treatment groups were made.|||Units on a scale||Standard Error|Least Squares Mean
2543670|NCT02972632|Secondary|Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 12|CGI-I assesses the participant's improvement (or worsening). The clinician assessed participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Higher scores indicated greater severity of illness.|Week 12|FAS included all participants who were enrolled in the treatment period and received at least one dose of the study drug and completed at least one GAS assessment postbaseline. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.|||score on a scale||Standard Deviation|Mean
2543671|NCT02972632|Secondary|Change From Baseline in Clinical Global Impression Scale Severity (CGI-S) at Week 12|CGI-S is a clinician rated scale designed to assess global severity of illness and change in the clinical condition over time. The CGI-S provides the clinician's impression of the participant's state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant's mental illness on a 7-point scale ranging from 1 (normal-not at all ill) to 7 (among the most extremely ill participants). Higher scores indicate greater severity of illness. A negative change from baseline indicates improvement.|Baseline and Week 12|FAS included all participants who were enrolled in the treatment period and received at least one dose of the study drug and completed at least one GAS assessment postbaseline. Number analyzed is the number of participants with evaluable data at the given time-point.|||score on a scale||Standard Deviation|Mean
2543672|NCT02972632|Secondary|Change From Baseline in 5-Item World Health Organization Well-being Index (WHO-5) Score at Week 12|WHO-5 is a short, self-administered questionnaire covering 5 positively worded items, related to positive mood (good spirits, relaxation), vitality (being active and waking up fresh and rested), and general interests (being interested in things). Each of the five items is rated from 0 (= not present) to 5 (= constantly present). Scores are summated, with raw score ranging from 0 to 25, with higher score meaning better well-being. A positive change from baseline indicates improvement.|Baseline and Week 12|FAS included all participants who were enrolled in the treatment period and received at least one dose of the study drug and completed at least one GAS assessment postbaseline. Number analyzed is the number of participants with evaluable data at the given time-point.|||score on a scale||Standard Deviation|Mean
2543673|NCT02972632|Secondary|Change From Baseline in Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q) Total Score at Week 12|"Q-LES-Q is a scale designed to allow researchers to assess the degree of a participant's quality of life in various areas of daily living. There is not a Total Score per se for the Q-LES-Q. The scale is divided into domains. Ninety-one of the 93 items are assembled into 8 categories: physical health/activities, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. Items are scored on a 5 point scale, from 1 (not at all or never) to 5 (frequently or all the time), to indicate the degree of enjoyment or satisfaction experienced by domain. Raw summary scores are expressed as a percentage of the maximum possible score within a given domain to facilitate comparisons across areas of functioning. The total score is based on the Overall Life Satisfaction question in General Activities and ranges from 1 to 5. A positive change from baseline indicates greater enjoyment/satisfaction."|Baseline and Week 12|FAS included all participants who were enrolled in the treatment period and received at least one dose of the study drug and completed at least one GAS assessment postbaseline. Number analyzed is the number of participants with evaluable data at the given time-point.|||score on a scale||Standard Deviation|Mean
2543674|NCT02972632|Secondary|Change From Baseline in Perceived Deficits Questionnaire-Depression (PDQ-D) at Weeks 6 and 12|"The PDQ-D is a 20-item, patient-reported questionnaire with a 7-day recall period. Scores for four subscales. All 20 items use the same 5-point ordinal categorical response scale to reflect the frequency of experiencing a specific cognitive problem in the past 7 days. Scores for each of the four measured subscales are calculated by assigning a value of 0 (never in the past 7 days), 1 (rarely - once or twice), 2 (sometimes - 3-5 times), 3 (often - about once a day), or 4 (very often - more than once a day) to each item, then summing the five items of that subscale, to produce a score ranging from 0 to 20. A total global score for overall cognitive dysfunction (range 0-80) is calculated by summing the four subscale scores. Higher scores for each subscale and for the total score indicate greater perceived cognitive dysfunction. A negative change from Baseline indicates improvement."|Baseline and Weeks 6 and 12|FAS included all participants who were enrolled in the treatment period and received at least one dose of the study drug and completed at least one GAS assessment postbaseline. Number analyzed is the number of participants with evaluable data at the given time-point.|||score on a scale||Standard Deviation|Mean
2543675|NCT02972632|Secondary|Change From Baseline in Patient Health Questionnaire (PHQ-9) Score at Weeks 6 and 12|PHQ-9 is a well-established participant reported outcome tool for assessment of change in depressive symptoms and is a sensitive measure of depression severity. The PHQ-9 consists of a 9-item scale originally developed for primary care settings, with 1 item corresponding to each of the 9 made symptom criteria for depression in diagnostic and statistical manual of mental disorders (DSM), asking if they have bothered the participant over the last 2 weeks. Each question is rated on a scale from 0 (not at all) to 3 (nearly every day). If any problems are answered 1 or higher, a final question on how difficult those problems made it to do work, take care of things at home, or get along with other people is completed, rated from not difficult at all to extremely difficult. The 9 questions are summed to a total score ranging from 0 to 27 with higher scores reflecting greater severity. A positive change from baseline indicates severe condition.|Baseline and Weeks 6 and 12|FAS included all participants who were enrolled in the treatment period and received at least one dose of the study drug and completed at least one GAS assessment postbaseline. Number analyzed is the number of participants with evaluable data at the given time-point.|||score on a scale||Standard Deviation|Mean
2543676|NCT02972632|Secondary|Change From Baseline in Total Goal Attainment Scale Score at Weeks 6 and 12|GAS is a tool to measure progress each participant has towards achieving their individualized goals. The standardized scoring was applied for statistical analysis. A semi-structured interview was conducted with each participant to conduct goal-setting at outset of study. Another evaluation took place at EOS visit to determine level of progress at that time. The score for each goal ranged from -2 (much worse) to +2 (much better). GAS yielded a norm-based score standardized to a mean of 50 with SD of 10. The total score ranges between 22.6 and 77.4. A positive change from baseline in the composite of 3 goals (50 or above) indicates response.|Baseline and Weeks 6 and 12|FAS included all participants who were enrolled in the treatment period and received at least one dose of the study drug and completed at least one GAS assessment postbaseline. Number analyzed is the number of participants with evaluable data at the given time-point.|||score on a scale||Standard Deviation|Mean
2543677|NCT02972632|Primary|Percentage of Participants Who Achieved Goal Attainment Scale (GAS) Score of ≥50 at Week 12|GAS is a tool to measure progress each participant has towards achieving their individualized goals. The standardized scoring was applied for statistical analysis. A semi-structured interview was conducted with each participant to conduct goal-setting at the outset of study. Another evaluation took place at end of study (EOS) visit to determine the level of progress at that time. The score for each goal ranged from -2 (much worse) to +2 (much better). GAS yielded a norm-based score standardized to a mean of 50 with a standard deviation (SD) of 10. Higher score indicates composite of 3 goals (50 or above) as response.|Week 12|Full analysis set (FAS) included all participants who were enrolled in the treatment period and received at least one dose of the study drug and completed at least one GAS assessment postbaseline. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.|||percentage of participants||95% Confidence Interval|Number
2543678|NCT02972554|Secondary|Change in Negative, High Arousal Emotion|"Self-report measure of affect (emotion) state using the Positive & Negative Affect Schedule Negative Affect (PANAS). Answered on a Likert scale from 0 (not at all) - 6 (very much). Mean score range is from 0-6. Higher numbers indicate more negative, high arousal emotions; low numbers indicate less negative, high arousal emotions. Three change scores were calculated from the four different rating measurement time points: a change in negative, high arousal emotions at the post-drug baseline from the pre-drug baseline; a change in emotions right before the Trier Social Stress Task (TSST) from the post-drug baseline; and a change in emotions during the TSST from the post-drug baseline."|Pre-drug baseline; 60-min post-drug administration baseline before stressor; 2-min before the stressor; 1-min post-stressor||||score on a scale||95% Confidence Interval|Mean
2543679|NCT02972554|Secondary|Change in Respiratory Sinus Arrhythmia|Mean level respiratory sinus arrhythmia (RSA) derived from electrocardiogram; measure of heart rate variability assessed as the ratio of low-to-high frequencies in the respiratory-cardiac power spectrum. Four different change scores were calculated: first, the change in average RSA from the 5-min pre-drug baseline to the 5-min post-drug baselines; second, the change in average RSA that occurred during the 2-min anticipatory stress speech preparation phase of the Trier Social Stress Test (TSST) from the post-drug baseline; third, the change in average RSA that occurred across the 15-min of the TSST (speech + math tasks) from the post-drug baseline; fourth and finally, the change in average RSA that occurred across 7-min in a post-stressor recovery period as compared to the post-drug baseline.|Pre-drug baseline; 60-min post-drug administration baseline before stressor; 2-min before the stressor; 15-min during stressor, 7-min recovery post-stressor||||Ratio||95% Confidence Interval|Mean
2543680|NCT02972554|Secondary|Change in Pre-Ejection Period|Mean level pre-ejection period (PEP; centered at zero) derived from impedance cardiography and electrocardiogram. Four different change scores were calculated: first, the change in average PEP from the 5-min pre-drug baseline to the 5-min post-drug baselines; second, the change in average PEP that occurred during the 2-min anticipatory stress speech preparation phase of the Trier Social Stress Test (TSST) from the post-drug baseline; third, the change in average PEP that occurred across the 15-min of the TSST (speech + math tasks) from the post-drug baseline; fourth and finally, the change in average PEP that occurred across 7-min in a post-stressor recovery period as compared to the post-drug baseline.|Pre-drug baseline; 60-min post-drug administration baseline before stressor; 2-min before the stressor; 15-min during stressor, 7-min recovery post-stressor||||milliseconds||95% Confidence Interval|Mean
2543681|NCT02972554|Secondary|Change in Salivary Alpha Amylase|Concentration of alpha amylase in saliva quantified quantified by enzyme kinetic method. Two different change scores were calculated: first, the pre-drug to post-drug baseline change and, second, the 15-min post-stressor change from post-drug baseline.|Pre-drug baseline; 60-min post-drug administration baseline before stressor; 15-min post-stressor||||picograms / mL||95% Confidence Interval|Mean
2543682|NCT02972554|Secondary|Change in Salivary Cortisol|Concentration of cortisol in saliva quantified quantified by chemiluminescence immunoassay with high sensitivity. Three different change scores were calculated from pre-drug to post-drug baselines, 15-min post-stressor from post-drug baseline, and 30-min post-stressor from post-drug baseline.|Pre-drug baseline; 60-min post-drug administration baseline before stressor; 15-min post-stressor; 30-min post-stressor||||nanomole/L||95% Confidence Interval|Mean
2543683|NCT02972554|Primary|Change in Interleukin-6 (IL-6)|Measured in blood plasma using enzyme-linked immunosorbent assay. Log-transformed prior to analysis to correct for skew in data. Four different change scores were calculated: first, change at post-drug from pre-drug baseline; second, the change at 30-min post-stressor from post-drug baseline; third, change at 60-min post-stressor from post-drug baseline; and fourth, change at 90-min post-stressor from post-drug baseline.|Pre-drug baseline; 60-min post-drug administration baseline before stressor; 30-min post-stressor; 60-min post-stressor; 90-min post-stressor||||log(picograms/mL)||95% Confidence Interval|Mean
2543684|NCT02972515|Secondary|Minutes of Guided Imagery Use Per Day|Interaction with the mHealth app will be measured automatically and unobtrusively by the app on an on-going basis. The app will collect the number of minutes per day that the guided imagery audio files are listened to.|Collected throughout each day for up to 90 days|62 feasibility participant with both baseline and 3-month data.|||minutes of guided imagery user per day||Standard Deviation|Mean
2543685|NCT02972515|Secondary|Servings of Fruit Per Day|Self-reported consumption of servings of fruits per day will be collected via online questionnaire at 3-months post-enrollment.|3 months|62 feasibility participants with data from both baseline and follow-up|||servings of fruit per day||Standard Deviation|Mean
2543686|NCT02972515|Secondary|Weekly Minutes of Exercise|Self-reported level of moderate to strenuous physical activity will be collected via online questionnaire at 3-months post-enrollment.|3 months|Data analyzed on 60 feasibility participants with both baseline and 3-month data.|||minutes of exercise per week||Standard Deviation|Mean
2543687|NCT02972515|Primary|Number of Participants Reporting Smoking Abstinence|Self-reported smoking abstinence will be collected via online questionnaire at 3-months post-enrollment.|3 months|63 feasibility participants with both baseline and 3-month data.|||Participants|||Count of Participants
2543688|NCT02972502|Secondary|Occurrence of Patient Return to the Emergency Department (ED) or Other Healthcare Provider for Headache/Migraine Within 48 Hours of ED Discharge|Occurrence of patient return to the ED or other healthcare provider for headache/migraine within 48 hours of ED discharge will be evaluated via chart review at 48 hours post discharge|48 hours post discharge|Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants.|||Participants|||Count of Participants
2543689|NCT02972502|Secondary|Need for Additional Medications Used in the Emergency Department (ED)|Need for additional medications in the ED will be evaluated via chart review at 48 hours post discharge|48 hours post discharge|Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants.|||Participants|||Count of Participants
2543690|NCT02972502|Primary|Change in Pain Score According to the Numeric Pain Intensity Scale|Numeric Pain Intensity scale is a standard rating tool for pain, ranging from 0-10, with 0=no pain and 10=worst pain imaginable.|Change from baseline (prior to treatment) to 1 hour post treatment (1 hour)|Study was terminated early. Information entered for n=49 participants. Data not collected for 11 participants.|||units on a scale||Standard Deviation|Mean
2543691|NCT02972359|Secondary|Change in the Pain Interference Score of the Brief Pain Inventory (BPI)|The Brief Pain Inventory (BPI) Interference Score is the mean value of 7 self-reported items in question 9 of the BPI Short Form Questionnaire. Participants rated their interference of pain with general activity, walking, work, sleep and other activities in the past 24 hours, with possible ratings from 0 (does not interfere) to 10 (completely interferes). The BPI interference Score ranges from 0 to 10, with higher values indicating greater pain interference of daily activities.|Baseline to Week 12 and Week 26|Full Analysis Set|||score on a scale||Standard Deviation|Mean
2543692|NCT02972359|Secondary|Patient Global Impression of Change (PGIC) at Week 26|"The Patient Global Impression of Change (PGIC) is a self-reported measure of perceived change in overall condition since the start of the study. Participants selected one of seven responses ranging from very much improved to very much worse. A response of very much improved or much improved is generally regarded as a clinically important improvement."|at Week 26|Full Analysis Set; 273 out of 316 participants attended the visit at Week 26 and were asked to complete the PGIC questionnaire.|||Participants|||Count of Participants
2543693|NCT02972359|Secondary|Patient Global Impression of Change (PGIC) at Week 12|"The Patient Global Impression of Change (PGIC) is a self-reported measure of perceived change in overall condition since the start of the study. Participants selected one of seven responses ranging from very much improved to very much worse. A response of very much improved or much improved is generally regarded as a clinically important improvement."|at Week 12|Full Analysis Set; 286 out of 316 participants attended the visit at Week 12 and were asked to complete the PGIC questionnaire.|||Participants|||Count of Participants
2543694|NCT02972359|Secondary|Number of Participants With Response to Treatment, Defined as at Least 50% Decrease From Baseline in the Current Pain Intensity Score|Participants with at least a 50 percent decrease in the current pain intensity score were considered to have responded to treatment.|Baseline, at Week 12 and Week 26|Full Analysis Set|||Participants|||Count of Participants
2543695|NCT02972359|Secondary|Number of Participants With Response to Treatment, Defined as at Least 30% Decrease From Baseline in the Current Pain Intensity Score|Participants with at least a 30 percent decrease in the current pain intensity score were considered to have responded to treatment.|Baseline, at Week 12 and Week 26|Full Analysis Set|||Participants|||Count of Participants
2543696|NCT02972359|Secondary|Change From Baseline in the Current Pain Intensity Score|"The current Complex Regional Pain Syndrome (CRPS)-related pain intensity score was captured at each visit using an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine, a higher score indicates more pain."|Baseline to Week 12 and Week 26|Full Analysis Set|||units on a scale||Standard Deviation|Mean
2543697|NCT02972359|Secondary|Number of Participants With Occurrence of Permanent Discontinuation From Treatment Due to an Adverse Event|The investigator could choose to permanently discontinue a participant from treatment if continued exposure of the participant to neridronic acid could have posed an undue risk to the participant.|Day 1 to Day 10|Safety Set|||Participants|||Count of Participants
2543698|NCT02972359|Primary|Number of Participants With Occurrence of Any Treatment Emergent Adverse Event (TEAE)|The primary endpoint of this trial was a binary endpoint assessing whether or not a participant experienced any TEAE.|Day 1 to Week 52|Safety Set|||Participants|||Count of Participants
2543699|NCT02971670|Secondary|Boosterability of BioMed rTSST-1 Variant Vaccine|ELISA IgG against rTSST-1. Boosterability was defined as an increase in TSST-1 Ab titer as compared to antibody titers after second vaccination.|through 6 months after third immunization|Out of 23 Subjects responding, 8 subjects were not interested to continue; 15 subjects were included as PP population.|||Participants|||Count of Participants
2543700|NCT02971670|Primary|Persistence of TSST-1 Antibodies|ELISA IgG against rTSST-1. Persistence of antibody was defined as a >/= 4-fold increase in TSST-1 Ab titer as compared to pre-vaccination values.|6-15 months after last immunization of Phase I||||Participants|||Count of Participants
2543701|NCT02971670|Primary|Number of Participants With Adverse Events as a Measure of Safety|Clinical observation and clinical laboratory values|through 6 months|Out of 23 Subjects responding, 8 subjects were not interested to continue; 15 subjects were included as PP population.|||participants|||Number
2543702|NCT02971631|Secondary|Total Meal Consumption|Total consumption amount of a standard meal during study intervention, measured in grams using a universal eating monitor.|150-210 minutes during infusion of Exendin 9-39 or placebo||||grams||Standard Error|Mean
2543703|NCT02971631|Secondary|Number of Participants With Infusion Related Adverse Events as Assessed by CTCAE v4||24 hours from onset of infusion.||||participants|||Number
2543704|NCT02971631|Secondary|Altered Food Motivation|Participant motivation to view particular food based cues is assessed by grip strength exerted to maintain those cues. Measure is undertaken during infusion at four timepoints - baseline (i.e. fasting), post oral glucose tolerance test (post-OGTT), before a standard meal (pre-meal) and after the meal (post-meal).|0-240 minutes during infusion of Exendin 9-39 or placebo (baseline or T0, post-OGTT, pre-m, assessed on four occasions using a validated grip strength surrogate of food motivation and measured as the area under the curve of a grip force monitoring curve.||||Newton seconds||Standard Error|Mean
2543705|NCT02971631|Secondary|Altered Food Attention.|Food motivation can be measured by response rates to visual cues while being distracted by food related images. Will be measured with and without GLP-1 blockade to investigate effects of GLP-1 on food attention behaviour. Measure is of difference in response time when visual cue is colocated with a food related image vs a non-food related image, indicating degree of bias in attention to food images. Measure is undertaken during infusion at four timepoints - baseline (i.e. fasting), post oral glucose tolerance test (post-OGTT), before a standard meal (pre-meal) and after the meal (post-meal).|0-240 minutes during infusion of Exendin 9-39 or placebo, assessed on four occasions (baseline or T0, post-OGTT, pre-meal, post-meal) using a validated dot-probe visual response tool and reported in response time (milliseconds).||||milliseconds||Standard Error|Mean
2543706|NCT02971631|Secondary|Decreased Hunger and Satiety Ratings During and After ad Libitum Meal|Will be measured on visual analogue scale and reported as a score out of 100. Higher value indicated more hunger and more satiety.|150-240 minutes during infusion of Exendin 9-39 or placebo and for 4 hours post-cessation of infusion.|Unfortunately it proved impossible to collect data on hunger and fullness during the ad libitum meal, due to the cognitive effects of the gastrectomy which all of this group had undergone, meaning participants were unwilling to accurately record these sensations while eating. This data is therefore meaningless and was not analysed.||||||
2543707|NCT02971631|Secondary|Eating Rate During ad Libitum Meal|As measured by universal eating monitor, total weight of a standardised meal consumed over a measured time in grams per minute.|150-210 minutes during infusion of Exendin 9-39 or placebo.||||grams/minute||Standard Error|Mean
2543708|NCT02971631|Secondary|Total Insulin Secretion|60 minute incremental area under the curve (i.e. total) insulin secretion during 50g oral glucose tolerance test while receiving infusion of GLP-1 antagonist. Please note participants will receive infusion of active compound for a maximum of four hours, with no expected effect of compound persisting for more than 30 minutes post-infusion.|Samples collected at 0, 15, 30, 45 and 60 minutes post oral glucose tolerance test.||||pmol*minute/l||Standard Error|Mean
2543709|NCT02971631|Primary|Nadir Blood Glucose|Lowest blood sugar reading during an oral glucose tolerance test while receiving infusion of GLP-1 antagonist. Please note participants will receive infusion of active compound for a maximum of four hours, with no expected effect of compound persisting for more than 30 minutes post-infusion.|As assessed during a 50g glucose tolerance test while receiving infusion of GLP-1 antagonist. At time 30-120 minutes of infusion of Exendin 9-39.|Crossover study - analysis by paired T test|||mmol/l||Standard Error|Mean
2543710|NCT02971605|Secondary|Change in Emotional Functioning Tasks Response Time (Milliseconds)|"These tasks measure emotional responding that may be altered by psilocybin.~Emotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images.~Emotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor.~Emotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative."|1-day pre (baseline), 1-week post, 1-month post session||||milliseconds||Standard Error|Mean
2543711|NCT02971605|Secondary|Change in Emotional Functioning Task Accuracy|"These tasks measure emotional responding that may be altered by psilocybin.~Emotional discrimination task: participants were presented with images of emotional facial expressions or shapes (control), and were instructed to discriminate between the images.~Emotion recognition task: participants were presented images of actors and were asked to identify the emotional facial expression (happy, sad, fear, angry, neutral) of each actor.~Emotional conflict Stroop task: participants were shown emotional facial expressions (targets) with emotional words overlain (distractors) and were asked to identify the valence of the facial expression, either positive or negative."|1 day pre (baseline), 1 week post, and 1 month post session||||percentage of correct responses||Standard Error|Mean
2543723|NCT02971293|Secondary|Change From Baseline in Breathlessness Individual Domain Score From Day 1 to Day 8 Post-treatment|"The efficacy of inhaled AZD8871 in patients with moderate to severe COPD will be assessed by measuring the change from baseline in Breathlessness, Cough Sputum Scale (BCSS) questionnaire breathlessness individual domain scores.~On a daily basis, patients rated breathlessness symptoms on a 5-point Likert scale (range 0-4, high scores indicating higher severity)."|From Day 1 to Day 8 post-treatment|Full analysis set (FAS): all randomised patients who received at least one dose of the IP, irrespective of their protocol adherence and continued participation in the study.|||Scores on a scale||Standard Error|Least Squares Mean
2543712|NCT02971605|Secondary|Change in Longitudinal Emotion and Mood Questionnaire Scores|"Participants were assessed on a variety of questionnaires that probed emotional functioning and mood state. Higher scores on each subscale are indicative of higher levels of each emotion/mood (e.g., low score on Depression (POMS) indicates low level of depressed mood).~Depression Anxiety Stress Scale (DASS): Range 0-56 on all subscales~Dispositional Positive Emotion Scale (DPES): Range 1-7 on all subscales~Positive & Negative Affect Schedule Expanded (PANAS-X): Range 0-50 on all subscales~Profile of Mood States (POMS): Ranges vary by subscale. Tension (0-36); Depression (0-60); Anger (0-48); Fatigue (0-28); Confusion (0-28); Vigor (0-36); Mood Disturbance (-36-168)~State Trait Anxiety Inventory (STAI): Range 20-80 on all subscales~Tellegen Absorption Scale (TAS): Range 0-34~Big Five Inventory (BFI): Range 1-5 on all subscales"|1 day pre (baseline), 1 week post, and 1 month post session|The Big Five Inventory (BFI) and the Tellegen Absorption Scale (TAS) were not administered at 1-week post, and were only administered at Baseline and 1-month post.|||score on a scale||Standard Error|Mean
2543713|NCT02971605|Primary|Amygdala Response to Stimuli in the Emotion Recognition Test|Blood oxygenation level-dependent (BOLD) percent signal change in response to stimuli in the emotion recognition task was measured in the left and right amygdala.|1 day pre (baseline), 1 week post, and 1 month post session||||BOLD percent signal change||Standard Error|Mean
2543714|NCT02971488|Secondary|Prevalence of Other Chronic Viral Infections in the Population Screened|Other viruses (HIV, HBV, HDV) using dried blood samples on WhatmanTM cards in subjects from Cañada Real based will be analysed. The prevalence of these infections will be calculated base on the total screened population.|2 years||||Participants|||Count of Participants
2543715|NCT02971488|Secondary|Percentage of Participants With Active HCV in Screened Population|Screening for HCV using dried blood samples on WhatmanTM cards in subjects from Cañada Real based on the results of the laboratory tests performed in phase I. The percentage of active HCV infections will be calculated from the total population of active drug addicts screened.|2 years||||Participants|||Count of Participants
2543716|NCT02971488|Primary|Percentage of Participants Who Achieved a Sustained Virological Response (SVR)|Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).|2 years||||Participants|||Count of Participants
2543717|NCT02971488|Primary|Percentage of Participants Who Started HCV Antiviral Therapy.|Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).|2 years||||Participants|||Count of Participants
2543718|NCT02971488|Primary|Percentage of Participants Who Were Evaluated at a HCV Clinic.|Evaluation of the effectiveness of the intervention. Subjects who had a positive result in the screening performed in Cañada Real Galiana will be contacted and offered the possibility of referral to HUIL, where they will have access to standard confirmation tests. Here, test accuracy will be evaluated at population level. Patients will have access to HCV treatment and will be followed for assessment of the impact of the program on patients' health (appointment in health centers, percentage of treated patients, and the percentage of virological response).|2 years||||Participants|||Count of Participants
2543719|NCT02971488|Primary|Percentage of HCV Infected Paticipants Whom Result of the Test Was Delivered to|Percentage of participants who had a positive HCV test and results of the test was delivered to them.|2 years||||Participants|||Count of Participants
2543720|NCT02971293|Secondary|Change From Baseline in Sputum Individual Domain Score From Day 9 to Day 14 Post-treatment|"The efficacy of inhaled AZD8871 in patients with moderate to severe COPD will be assessed by measuring the change from baseline in Breathlessness, Cough Sputum Scale (BCSS) questionnaire sputum individual domain scores.~On a daily basis, patients rated sputum symptoms on a 5-point Likert scale (range 0-4, high scores indicating higher severity)."|From Day 9 to Day 14 post-treatment|Full analysis set (FAS): all randomised patients who received at least one dose of the IP, irrespective of their protocol adherence and continued participation in the study.|||Scores on a scale||Standard Error|Least Squares Mean
2543721|NCT02971293|Secondary|Change From Baseline in Sputum Individual Domain Score From Day 1 to Day 8 Post-treatment|"The efficacy of inhaled AZD8871 in patients with moderate to severe COPD will be assessed by measuring the change from baseline in Breathlessness, Cough Sputum Scale (BCSS) questionnaire sputum individual domain scores.~On a daily basis, patients rated sputum symptoms on a 5-point Likert scale (range 0-4, high scores indicating higher severity)."|From Day 1 to Day 8 post-treatment|Full analysis set (FAS): all randomised patients who received at least one dose of the IP, irrespective of their protocol adherence and continued participation in the study.|||Scores on a scale||Standard Error|Least Squares Mean
2543722|NCT02971293|Secondary|Change From Baseline in Breathlessness Individual Domain Score From Day 9 to Day 14 Post-treatment|"The efficacy of inhaled AZD8871 in patients with moderate to severe COPD will be assessed by measuring the change from baseline in Breathlessness, Cough Sputum Scale (BCSS) questionnaire breathlessness individual domain scores.~On a daily basis, patients rated breathlessness symptoms on a 5-point Likert scale (range 0-4, high scores indicating higher severity)."|From Day 9 to Day 14 post-treatment|Full analysis set (FAS): all randomised patients who received at least one dose of the IP, irrespective of their protocol adherence and continued participation in the study.|||Scores on a scale||Standard Error|Least Squares Mean
2543724|NCT02971293|Secondary|Change From Baseline in Cough Individual Domain Score From Day 9 to Day 14 Post-treatment|"The efficacy of inhaled AZD8871 in patients with moderate to severe COPD will be assessed by measuring the change from baseline in Breathlessness, Cough Sputum Scale (BCSS) questionnaire cough individual domain scores.~On a daily basis, patients rated cough symptoms on a 5-point Likert scale (range 0-4, high scores indicating higher severity)."|From Day 9 to Day 14 post-treatment|Full analysis set (FAS): all randomised patients who received at least one dose of the IP, irrespective of their protocol adherence and continued participation in the study.|||Scores on a scale||Standard Error|Least Squares Mean
2543725|NCT02971293|Secondary|Change From Baseline in Cough Individual Domain Score From Day 1 to Day 8 Post-treatment|"The efficacy of inhaled AZD8871 in patients with moderate to severe COPD will be assessed by measuring the change from baseline in Breathlessness, Cough Sputum Scale (BCSS) questionnaire cough individual domain scores.~On a daily basis, patients rated cough symptoms on a 5-point Likert scale (range 0-4, high scores indicating higher severity)."|From Day 1 to Day 8 post-treatment|Full analysis set (FAS): all randomised patients who received at least one dose of the IP, irrespective of their protocol adherence and continued participation in the study.|||Scores on a scale||Standard Error|Least Squares Mean
2543726|NCT02971293|Secondary|Change From Baseline in BCSS Questionnaire Total Score From Day 9 to Day 14 Post-treatment|"The efficacy of inhaled AZD8871 in patients with moderate to severe COPD was assessed by measuring the change from baseline in Total score of the Breathlessness, Cough Sputum Scale (BCSS) questionnaire.~The BCSS questionnaire is a 3-item patient-reported outcome measure. On a daily basis, patients rated 3 symptoms (breathlessness, cough and sputum) on a 5-point Likert scale (range 0-4, high scores indicating higher severity). The BCSS questionnaire Total Score is the sum of the 3 symptom scores, ranging from 0-12 (lowest-highest severity)."|From Day 9 to Day 14 post-treatment|Full analysis set (FAS): all randomised patients who received at least one dose of the IP, irrespective of their protocol adherence and continued participation in the study.|||Scores on a scale||Standard Error|Least Squares Mean
2543727|NCT02971293|Secondary|Change From Baseline in BCSS Questionnaire Total Score From Day 1 to Day 8 Post-treatment|"The efficacy of inhaled AZD8871 in patients with moderate to severe COPD was assessed by measuring the change from baseline in Total score of the Breathlessness, Cough Sputum Scale (BCSS) questionnaire.~The BCSS questionnaire is a 3-item patient-reported outcome measure. On a daily basis, patients rated 3 symptoms (breathlessness, cough and sputum) on a 5-point Likert scale (range 0-4, high scores indicating higher severity). The BCSS questionnaire Total Score is the sum of the 3 symptom scores, ranging from 0-12 (lowest-highest severity)."|From Day 1 to Day 8 post-treatment|Full analysis set (FAS): all randomised patients who received at least one dose of the IP, irrespective of their protocol adherence and continued participation in the study.|||Scores on a scale||Standard Error|Least Squares Mean
2543728|NCT02971293|Secondary|Change From Baseline in Peak FEV1 Over the Treatment Duration (Days 1-15)|The efficacy of inhaled AZD8871 in patients with moderate to severe COPD was assessed by measuring the change in Peak FEV1|over the treatment duration (Days 1-15)|Full analysis set (FAS): all randomised patients who received at least one dose of the IP, irrespective of their protocol adherence and continued participation in the study.|||L||Standard Error|Least Squares Mean
2543729|NCT02971293|Secondary|Change From Baseline in Peak FEV1 at Day 14|The efficacy of inhaled AZD8871 in patients with moderate to severe COPD was assessed by measuring the change in Peak FEV1|on Day 14|Full analysis set (FAS): all randomised patients who received at least one dose of the IP, irrespective of their protocol adherence and continued participation in the study.|||L||Standard Error|Least Squares Mean
2543730|NCT02971293|Secondary|Change From Baseline in Peak FEV1 at Day 8|The efficacy of inhaled AZD8871 in patients with moderate to severe COPD was assessed by measuring the change in Peak FEV1|on Day 8|Full analysis set (FAS): all randomised patients who received at least one dose of the IP, irrespective of their protocol adherence and continued participation in the study.|||L||Standard Error|Least Squares Mean
2543731|NCT02971293|Secondary|Change From Baseline in Peak FEV1 at Day 1 (Single Dose)|The efficacy of inhaled AZD8871 in patients with moderate to severe COPD was assessed by measuring the change in Peak FEV1|on Day 1|Full analysis set (FAS): all randomised patients who received at least one dose of the IP, irrespective of their protocol adherence and continued participation in the study.|||L||Standard Error|Least Squares Mean
2543732|NCT02971293|Secondary|Change From Baseline in Trough FEV1 Over the Treatment Duration (Days 1-15)|The efficacy of inhaled AZD8871 in patients with moderate to severe COPD was assessed by measuring the change in trough FEV1 over the treatment duration from Day 1 to Day 15|Days 1-15|Full analysis set (FAS): all randomised patients who received at least one dose of the IP, irrespective of their protocol adherence and continued participation in the study.|||L||Standard Error|Least Squares Mean
2543733|NCT02971293|Secondary|Change From Baseline in Trough FEV1 at Day 8 (Pre-dose)|The efficacy of inhaled AZD8871 in patients with moderate to severe COPD was assessed by measuring the change in trough FEV1 on Day 8 (pre-dose)|on Day 8 (pre-dose)|Full analysis set (FAS): all randomised patients who received at least one dose of the IP, irrespective of their protocol adherence and continued participation in the study.|||L||Standard Error|Least Squares Mean
2543734|NCT02971293|Secondary|Change From Baseline in Trough FEV1 at Day 1 (Single Dose)|The efficacy of inhaled AZD8871 in patients with moderate to severe COPD was assessed by measuring the change in trough FEV1 on Day 1|on Day 1|Full analysis set (FAS): all randomised patients who received at least one dose of the IP, irrespective of their protocol adherence and continued participation in the study.|||L||Standard Error|Least Squares Mean
2543735|NCT02971293|Secondary|Cavg of AZD8871 and Its Metabolites During a Dosing Interval (Day 14)|Average plasma concentration during a dosing interval calculated on Day 14 of each treatment period.|Pre-dose and 30 min, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Day 14.|Pharmacokinetic analysis set: defined as all patients in the safety analysis set who received at least 1 dose of AZD8871 (100 μg or 600 μg), had at least 1 evaluable parameter out of Cmax, AUC or AUClast for AZD8871, and were assumed not to be affected by factors such as protocol deviations.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2543736|NCT02971293|Secondary|Accumulation Ratio for AUC0-24 (RacAUC[0-24]) of AZD8871 and Its Metabolites (Day 14)|Accumulation ratio for AUC0-24 estimated as AUC0-24 on Day 14 / AUC0-24 on Day 1 in each treatment period.|Pre-dose and 30 min, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 14.|Pharmacokinetic analysis set: defined as all patients in the safety analysis set who received at least 1 dose of AZD8871 (100 μg or 600 μg), had at least 1 evaluable parameter out of Cmax, AUC or AUClast for AZD8871, and were assumed not to be affected by factors such as protocol deviations.|||pg*h/mL||Full Range|Mean
2543737|NCT02971293|Secondary|Accumulation Ratio for Cmax (RacCmax) of AZD8871 and Its Metabolites (Day 14)|Accumulation ratio for Cmax estimated as (Cmax on Day 14 / Cmax on Day 1) in each treatment period.|Pre-dose and 30 min, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1 and Day 14.|Pharmacokinetic analysis set: defined as all patients in the safety analysis set who received at least 1 dose of AZD8871 (100 μg or 600 μg), had at least 1 evaluable parameter out of Cmax, AUC or AUClast for AZD8871, and were assumed not to be affected by factors such as protocol deviations.|||pg/mL||Full Range|Mean
2543738|NCT02971293|Secondary|AUC0-24 of AZD8871 and Its Metabolites (Multiple Doses, Day 14)|Area under the plasma concentration-curve from time zero to 24 hours post-dose calculated on Day 14 of each treatment period.|Pre-dose and 30 min, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Day 14.|Pharmacokinetic analysis set: defined as all patients in the safety analysis set who received at least 1 dose of AZD8871 (100 μg or 600 μg), had at least 1 evaluable parameter out of Cmax, AUC or AUClast for AZD8871, and were assumed not to be affected by factors such as protocol deviations|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2543739|NCT02971293|Secondary|AUC0-24 of AZD8871 and Its Metabolites (Single Dose)|Area under the plasma concentration-curve from time zero to 24 hours post-dose calculated on Day 1 of each treatment period.|Pre-dose and 30 min, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1.|Pharmacokinetic analysis set: defined as all patients in the safety analysis set who received at least 1 dose of AZD8871 (100 μg or 600 μg), had at least 1 evaluable parameter out of Cmax, AUC or AUClast for AZD8871, and were assumed not to be affected by factors such as protocol deviations.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2543740|NCT02971293|Secondary|AUClast of AZD8871 and Its Metabolites (Multiple Doses, Day 14)|Area under the plasma concentration-curve from time zero to the last quantifiable time point (24 hours post-dose) calculated on Day 14 of each treatment period.|Pre-dose and 30 min, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Day 14.|Pharmacokinetic analysis set: defined as all patients in the safety analysis set who received at least 1 dose of AZD8871 (100 μg or 600 μg), had at least 1 evaluable parameter out of Cmax, AUC or AUClast for AZD8871, and were assumed not to be affected by factors such as protocol deviations.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2543741|NCT02971293|Secondary|AUClast of AZD8871 and Its Metabolites (Single Dose)|Area under the plasma concentration-curve from time zero to the last quantifiable time point (24 hours post-dose) calculated on Day 1 of each treatment period.|Pre-dose and 30 min, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1.|Pharmacokinetic analysis set: defined as all patients in the safety analysis set who received at least 1 dose of AZD8871 (100 μg or 600 μg), had at least 1 evaluable parameter out of Cmax, AUC or AUClast for AZD8871, and were assumed not to be affected by factors such as protocol deviations.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2543742|NCT02971293|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of AZD8871 and Its Metabolites (Multiple Doses, Day 14)|Time to reach maximum concentration taken directly from the individual concentration-time curve on Day 14 of each treatment period.|Pre-dose and 30 min, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Day 14.|Pharmacokinetic analysis set: defined as all patients in the safety analysis set who received at least 1 dose of AZD8871 (100 μg or 600 μg), had at least 1 evaluable parameter out of Cmax, AUC or AUClast for AZD8871, and were assumed not to be affected by factors such as protocol deviations.|||h||Full Range|Median
2543743|NCT02971293|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of AZD8871 and Its Metabolites (Single Dose)|Time to reach maximum concentration taken directly from the individual concentration-time curve on Day 1 of each treatment period.|Pre-dose and 30 min, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1.|Pharmacokinetic analysis set: defined as all patients in the safety analysis set who received at least 1 dose of AZD8871 (100 μg or 600 μg), had at least 1 evaluable parameter out of Cmax, AUC or AUClast for AZD8871, and were assumed not to be affected by factors such as protocol deviations.|||h||Full Range|Median
2543744|NCT02971293|Secondary|Observed Maximum Plasma (Cmax) of AZD8871 and Its Metabolites (Multiple Doses, Day 14)|Observed maximum concentration, taken directly from the individual concentration-time curve, on Day 14 of each treatment period.|Pre-dose and 30 min, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Day 14.|Pharmacokinetic analysis set: defined as all patients in the safety analysis set who received at least 1 dose of AZD8871 (100 μg or 600 μg), had at least 1 evaluable parameter out of Cmax, AUC or AUClast for AZD8871, and were assumed not to be affected by factors such as protocol deviations.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2543745|NCT02971293|Secondary|Observed Maximum Plasma (Cmax) of AZD8871 and Its Metabolites (Single Dose)|Observed maximum concentration, taken directly from the individual concentration-time curve, on Day 1 of each treatment period.|Pre-dose and 30 min, 1, 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1.|Pharmacokinetic analysis set: defined as all patients in the safety analysis set who received at least 1 dose of AZD8871 (100 μg or 600 μg), had at least 1 evaluable parameter out of Cmax, AUC or AUClast for AZD8871, and were assumed not to be affected by factors such as protocol deviations.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2543746|NCT02971293|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1)|The efficacy of inhaled AZD8871 in patients with moderate to severe COPD was assessed by measuring the change in trough FEV1 on Day 15|On Day 15|Full analysis set (FAS): all randomised patients who received at least one dose of the IP, irrespective of their protocol adherence and continued participation in the study.|||L||Standard Error|Least Squares Mean
2543747|NCT02971202|Secondary|Adipose Tissue Insulin Sensitivity|Insulin sensitivity at fat is directly proportional to insulin's ability to suppress lipolysis. Thus, we will determine the extent to which submaximal insulin stimulation (4 1/2 hours into the study) suppresses glycerol and non-esterified free fatty acids (NEFAs) compared to baseline. The extent to which these two metabolites are suppressed is directly proportional to insulin sensitivity in adipose tissue. Here the suppression of NEFA is taken as the secondary outcome parameter.|4 1/2 hours into clamp study||||μmol/L||95% Confidence Interval|Mean
2543748|NCT02971202|Secondary|Hepatic Insulin Sensitivity|Glucose production (Ra) will be determined using stable isotopic tracer techniques. The extent to which Ra is suppressed at the end of 4 1/2 hours (when glucose Ra by liver has been submaximally suppressed) compared to basal (ΔRa) is directly proportional to hepatic insulin sensitivity.|4 1/2 hours into clamp study||||mg/kg FFM/min||95% Confidence Interval|Mean
2543749|NCT02971202|Primary|Whole-body Glucose Utilization (Rd)|The primary outcome is the degree to which Rd (determined using isotopic glucose tracer techniques) during maximal insulin stimulation differs between cohorts.|End of clamp study (the study will last 8 hours)||||mg/kg FFM/min||95% Confidence Interval|Mean
2543766|NCT02970552|Secondary|Birth Weight|Number of participants with neonates weighing less than 2500 grams at birth|Visit 10.0 (Delivery)|Randomized participants with birth weight data ascertained|||Participants|||Count of Participants
2547124|NCT02912195|Primary|Pain Score (NRS 0-10)|Pain score is rated on the Numeric Rating Scale from 0-10. 0 represents no pain and 10 represents the worst possible pain.|At 60 minutes||||units on a scale||95% Confidence Interval|Mean
2543750|NCT02971007|Secondary|Change in Composite Clinical Cure Score|"The percent change from baseline to Day 12 (Test of Cure Visit) of the composite clinical cure score of signs (erythema, edema or excoriation) and symptoms (itching, burning or irritation) on a scale of 0 to 3 for each sign and symptom where 0 = none (complete absence of any sign or symptom); 1 = mild (slight); 2 = moderate (definitely present) or 3 = severe (marked/intense). The maximum score at baseline = 18 (score of 3 for each sign and symptom). The minimum score at baseline = 4 (score of 2 for at least 2 signs or symptoms). A lower score at Day 12 represents a better outcome.~The mean percent change from baseline score to Day 12 score is presented for each arm as a negative number and represents a decrease in severity of signs and symptoms. A bigger decrease represents a better outcome."|Between randomization visit (Baseline) and Day 12 visit (Test of Cure)|All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline|||percent change||Standard Deviation|Mean
2543751|NCT02971007|Secondary|Overall Response|Number of patients with overall response at Day 12 (Test of cure visit) of composite signs and symptoms defined as overall success (achievement of both a clinical cure and microbiological eradication); overall failure (clinical failure or microbiological persistence) or overall indeterminate (insufficient data are available to determine if the patient is an overall success or failure).|12 Days|All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline|||Participants|||Count of Participants
2543752|NCT02971007|Secondary|Mycological Outcome Assessed at Test of Cure|Number of patients with mycological eradication (vaginal swab culture negative for growth of baseline Candida species); mycological persistence (vaginal swab culture positive for growth of baseline Candida species); or mycological indeterminate (vaginal swab culture not available or the culture cannot be interpreted or is considered contaminated)|12 days|All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline|||Participants|||Count of Participants
2543753|NCT02971007|Primary|Clinical Outcome Assessed at Test of Cure Visit|Number of patients determined to be a Clinical Cure (resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment); Clinical Failure (incomplete resolution of signs and symptoms of VVC that were present at baseline or new signs and symptoms have developed and require the initiation of non-study antifungal drugs); or Clinical indeterminate (insufficient data are available to determine if the subject is a cure or failure)|12 days|All randomized participants who had a Candida species isolated on culture of vaginal specimen at baseline|||Participants|||Count of Participants
2543754|NCT02970981|Secondary|Immune Response Assessment||12 Weeks|||||||
2543755|NCT02970981|Secondary|Time to Relapse|Time to relapse will be reported (in months post-treatment) to assess the preliminary efficacy of the study drugs.|Up to 4 years|||||||
2543756|NCT02970981|Primary|Number of Cases of Adverse Events Occurring During Study|The adverse events are evaluated per Common Terminology Criteria for Adverse Events (CTCAE) V4.|12 weeks post-treatment start||||cases of adverse events|||Number
2543757|NCT02970812|Primary|Waist Circumference|Waist circumference was measured by a tape|12 weeks||||cm||Standard Deviation|Mean
2543758|NCT02970669|Secondary|Change in Mean Activity (Counts Per Minute) During Sleep From Baseline to Week 9 and 16|Change in mean activity (counts per minute) during sleep from baseline phase (mean of data collected during week -1 for Sacubitril/Valsartan and mean of data collected during week 8 for Enalapril) to week 9 and 16 (mean of data collected during week 9 and 16), as measured by actigraphy (activity counts per minute during daily sleep period, wrist-worn accelerometer).|Baseline (Sacubitril/Valsartan: week -1 / Enalapril: week 8), week 9 and 16|Full Analysis Set|||counts/minute||Standard Deviation|Mean
2543759|NCT02970669|Secondary|Change in Mean Activity (Counts Per Minute) During Sleep From Baseline to Week 1|Change in mean activity (counts per minute) during sleep from baseline phase (mean of data collected during week -1) to week 1 (mean of data collected during week 1), as measured by actigraphy (activity counts per minute during daily sleep period, wrist-worn accelerometer).|Baseline, Week 1|Full Analysis Set|||counts/minute||Standard Error|Least Squares Mean
2543760|NCT02970669|Secondary|Change in Mean Activity (Counts Per Minute) During Sleep From Baseline to Week 8|Change in mean activity (counts per minute) during sleep from baseline phase (mean of data collected during week -1) to the final randomized treatment phase measurement (mean of data collected during week 8), as measured by actigraphy (activity counts per minute during daily sleep period, wrist-worn accelerometer).|Baseline, Week 8|Full Analysis Set|||counts/minute||Standard Error|Least Squares Mean
2543761|NCT02970669|Secondary|Change in Mean Activity Counts During Most Active 30 Minutes of Day From Baseline to Week 9 and 16|Change in mean activity counts during most active 30 minutes of day from baseline phase (mean of data collected during week -1 for Sacubitril/Valsartan and mean of data collected during week 8 for Enalapril) to week 9 and 16 (mean of data collected during weeks 9 and 16), as measured by actigraphy (total counts per 30 min period collected during the most active 30 minutes of each day).|Baseline (Sacubitril/Valsartan: week -1/ Enalapril: week 8), week 9 and 16|Full Analysis Set|||counts||Standard Deviation|Mean
2543762|NCT02970669|Secondary|Change in Mean Activity Counts During Most Active 30 Minutes of Day From Baseline to Week 1|Change in mean activity counts during most active 30 minutes of day from baseline phase (mean of data collected during week -1) to week 1 (mean of data collected during week 1), as measured by actigraphy (total counts per 30 min period collected during the most active 30 minutes of each day).|Baseline, Week 1|Full Analysis Set|||counts||Standard Error|Least Squares Mean
2543763|NCT02970669|Primary|Ratio of Mean Activity Counts Collected During the Most Active 30 Minutes of the Subject's Day Between Week 8 and Baseline|The primary endpoint is the ratio in mean activity counts collected during the most active 30 minutes of the subject's day between the final randomized treatment phase measurement (mean of endpoint data collected each day during week 8) and baseline phase (mean of endpoint data collected each day during week -1), as measured by wrist-worn accelerometer collected actigraphy (total counts per 30 min period collected during the most active 30 minutes of each day). A ratio > 1 indicates an increase in mean activity counts from baseline to week 8.|Baseline, week 8|Full Analysis Set|||Ratio||95% Confidence Interval|Geometric Mean
2543764|NCT02970552|Secondary|Adverse Events|Number of women experiencing a serious adverse event or event that resulted in study product discontinuation|Enrollment through Visit 10.0 (Delivery)||||Participants|||Count of Participants
2543765|NCT02970552|Secondary|Stillbirth|Number of participants who experienced a stillbirth|Visit 10.0 (Delivery)||||Participants|||Count of Participants
2543770|NCT02970552|Secondary|Sensitivity, Specificity, and Predictive Value of Dose Diaries|Comparison of self-reported adherence rates (Dose Diary/DD) and use of returned applicators measured by dye stain assay (DSA)|Enrollment through 36th gestational week, an overall total of up to 17 weeks|Dose diaries completed by randomized participants returned at each follow-up visit, reported among participants who returned for at least 1 visit. Outcome assessed the reliability of dose diaries against DSA gold standard regardless of study arm to measure feasibility for future use. Estimates are presented in aggregate per original analysis plan.|||Proportion of ppts correctly identified|Daily dose diaries|95% Confidence Interval|Number
2543771|NCT02970552|Secondary|Reported Barriers to Adherence to Study Product|Number of participants reporting challenges with taking the study medication as measured on the Exit Satisfaction Survey. The survey was administered by a study nurse who asked each participant what was the hardest part about taking the medication and presented all possible answer choices. Participant were asked to select only one answer.|Visit 9.0 (36 weeks of gestation)|131 randomized participants who completed an exit satisfaction survey|||Participants|||Count of Participants
2543772|NCT02970552|Secondary|Acceptability of a Vaginal Medication to Prevent Preterm Birth|Number of participants reporting specific attitudes about medications for the prevention of preterm birth (PTB), including acceptability of daily vaginal administration as measured on the Exit Satisfaction Survey using a Likert scale of five possible options ranging from strongly agree to strongly disagree. The form included a range of facial illustrations to facilitate comprehension of the answer choices, particularly for illiterate participants.|Visit 9.0 (36 weeks of gestation)|131 randomized participants who completed an exit satisfaction survey|||Participants|||Count of Participants
2543773|NCT02970552|Secondary|Summary of Reported Knowledge, Attitudes, and Practices Related to HIV, Antiretroviral Therapy (ART), Risk of Preterm Birth, and Participation in Placebo Controlled Randomized Clinical Trials (RCTs)|Number of participants reporting attitudes and practices related to participation in placebo controlled RCTs during a semi-structured interview. Participants were selected for an interview based on their overall adherence rates, including those with excellent adherence throughout the study and those with lower adherence rates early or late in their participation. A trained female staff member conducted each 30-minute interview using an interview guide. Participants were asked about their attitudes toward participation in the study and research in general as HIV-infected women taking ART and at risk of preterm birth, but they were not specifically asked about their underlying knowledge of these conditions. Interviews were audio-taped, transcribed, and translated into English as necessary.|Late in pregnancy or postpartum|A sample of enrolled participants selected to participate in a semi-structured interview. Investigators included 30 trial participants based on expectations regarding saturation of qualitative themes.|||Participants|||Count of Participants
2543774|NCT02970552|Secondary|Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study|Number of participants reporting barriers and facilitators to study product adherence, returning used applicators, and retention in the study during a semi-structured interview. Participants were selected for an interview based on their overall adherence rates, including those with excellent adherence throughout the study and those with lower adherence rates early or late in their participation. A trained female staff member conducted each 30-minute interview using an interview guide. Interviews were audiotaped, transcribed, and translated into English as necessary.|Late in pregnancy or postpartum|A sample of enrolled participants selected to participate in a semi-structured interview. Investigators included 30 trial participants based on expectations regarding saturation of qualitative themes.|||Participants|||Count of Participants
2543775|NCT02970552|Secondary|Acceptability of Use of Vaginal Progesterone (VP)|Semi-structured interviews will be held with a random sample of participants who enroll and those who decline enrollment.|At enrollment (20-24 weeks gestation), at 28 weeks gestation, and at 36 weeks gestation|Activation was delayed by 6 months because of a protracted regulatory process. Resulting low resources limited investigators' ability to conduct interviews at all specified times or with decliners. Investigators did conduct a single interview with a sample of participants late in pregnancy or postpartum; these data are captured in outcomes #3 and 4||||||
2543776|NCT02970552|Primary|Adequate Adherence to Study Product|Number of participants who achieved adequate adherence to study product, defined as proper self-administration of at least 80% of prescribed study product doses, as measured by a dye stain assay of returned applicators|Enrollment through 36th gestational week, an overall total of up to 17 weeks|Participants who returned for at least one follow-up study visit following enrollment|||Participants|||Count of Participants
2543777|NCT02970162|Other Pre-specified|Triple Timed Up and Go Walk Test (3TUG)|The 3TUG is a functional mobility test that requires a patient to stand up from a straight-backed armchair, walk 3 meters, turn around, walk back, and sit down in the chair. A modification of this is where the individual performs the test 3 times without pause, and the measurement is the average time required to complete each of the 3 repetitions. Based upon literature reports that a significant change in gait for a similar walk-test is an increase in time of more than 20%, this has been incorporated into the endpoint.|change from baseline in 3TUG at end of day 4|The number and proportion of patients with a ≥20% increase in 3TUG average time|||Participants|||Count of Participants
2543778|NCT02970162|Secondary|Change in Clinician's Global Impression of Improvement (CGI-I) at Day 4 Compared to Baseline|The CGI-I captures the Investigator's global impression of the patient's improvement or worsening from baseline status. The 7-point scale is scored by the Investigator based on changes in symptoms, behavior, and functional abilities. Each symptom is rated as 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), or 7 (very much worse). The total score can range from 0 to 49. A higher score indicates a worse outcome.|change from baseline in CGI-I score at end of day 4||||scores on a scale||Standard Deviation|Mean
2543779|NCT02970162|Primary|Subject Global Impression (SGI) Score|The SGI is a 7-point scale on which the patient rates their global impression of the effects of a study treatment (1=terrible to 7=delighted). The SGI was assessed by the patient or the patient's parent/guardian/caregiver if the patient was unable to complete the SGI. The SGI has demonstrated concordance with the physician's assessment of improvement.|change from baseline in SGI score at end of day 4||||scores on a scale||Standard Deviation|Mean
2544326|NCT02962908|Other Pre-specified|Unsolicited AEs and SAEs|To evaluate unsolicited AEs and SAEs in all subjects|From the start of the vacciantion until study completion for each subject, approximately no more than 7 months|Safety Population: all subjects that received at least one vaccination|||events|||Number
2543780|NCT02970162|Primary|Quantitative Myasthenia Gravis (QMG) Score|The QMG is a physician-rated test including 13 assessments such as facial strength, swallowing, grip strength, and duration of time that limbs can be maintained in outstretched positions. Each assessment is graded as 0 (none), 1 (mild), 2 (moderate), or 3 (severe), for a total range of 0-39. A higher total score indicates a worse outcome.|change from baseline in QMG score at end of day 4||||scores on a scale||Standard Deviation|Mean
2543781|NCT02970032|Secondary|Number of Rate Adjustments|Heparin rate adjustments were made for out of range anti-Xa levels (<0.1 and >0.35)|Through study completion, an average of 1 year.|During the dose adjustment period, anti-Xa levels were monitored and dose adjustments made per the pilot protocol.|||Rate adjustments||Full Range|Mean
2543782|NCT02970032|Primary|Number of Participants With Anti-Xa Levels Within Target Range (0.1-0.35 IU/mL)|Anti-Xa levels are used to monitor anticoagulant therapy.|Through study completion, an average of 1 year.||||Participants|||Count of Participants
2543783|NCT02969876|Secondary|Rey Auditory Verbal Learning Test|A cognitive measure sensitive to learning and memory. Minimum score is a zero. Maximum score is a 75. A higher score means a better outcome|6 weeks||||number of words recalled||Standard Deviation|Mean
2543784|NCT02969876|Secondary|Digital Symbol Substitution Test|A cognitive measure sensitive to learning and memory. Participants are given 90 seconds to match as many symbols to numbers according to a key located on the top of the page. A higher score means a better outcome.|6 weeks||||number of substitutions||Standard Deviation|Mean
2543785|NCT02969876|Primary|Quick Inventory of Depressive Symptomatology - Clinician Version (QIDS-C)|This scale is designed to assess the severity of depressive symptoms. The minimum score is a 0 (zero) and the maximum score is a 27, and a higher score means a worse outcome.|6 weeks||||score on a scale||Standard Deviation|Mean
2543786|NCT02969863|Primary|Percentage of Time Spent With Dexcom CGMG < 60 mg/dl|A measure of hypoglycemia capturing amount of time the continuous glucose monitor is reading less than 60 mg/dl|days 2-7||||percentage of time||Standard Deviation|Mean
2543787|NCT02969655|Secondary|Maximum Concentration (Cmax) of Plasma Daprodustat|Blood samples for PK analysis of daprodustat were collected as the time points provided. PK parameters were calculated by standard non-compartmental analysis according to current working practices and using the currently supported version of WinNonlin (version 6.3 or higher). Data has been provided as a consolidated values for at all time-points (0,1,2,3,and 4 hours post-dose) as provided for a single value at Weeks 12 and 24 respectively. Data was not calculated for darbepoetin alfa group as the primary interest of analysis was Daprodustat and not comparator drug (darbepoetin alfa). Data is combined from Week 12 and Week 24 data.|0, 1, 2, 3, and 4 hours post-dose at Week 12 and Week 24|PK Population|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2543788|NCT02969655|Secondary|Area Under Plasma Concentration Curve From Time Zero to 4 Hours (AUC [0 - 4]) of Plasma Daprodustat|Blood samples for Pharmacokinetic (PK) analysis of daprodustat were collected as the time points provided. PK parameters were calculated by standard non-compartmental analysis according to current working practices and using the currently supported version of WinNonlin (version 6.3 or higher). NA indicates geometric co-efficient of variation could not be calculated as a single participant was analyzed. Data has been provided as a consolidated values for at all time-points (0,1,2,3,and 4 hours post-dose) as provided for a single value at Weeks 12 and 24 respectively. PK population comprised of all daprodustat-treated participants from whom PK samples were collected and analyzed. Data was not calculated for darbepoetin alfa group as the primary interest of analysis was Daprodustat and not comparator drug (darbepoetin alfa). Data is combined from Week 12 and Week 24 data.|0, 1, 2, 3, and 4 hours post-dose at Week 12 and Week 24|PK Population|||Hours*nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2543789|NCT02969655|Secondary|Number of Episodes With Hgb Level of More Than 13.0 g/dL|Number of episodes with Hgb level of more than 13.0 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have been presented.|Up to Week 52|ITT Population|||Episodes|||Number
2543790|NCT02969655|Secondary|Number of Participants Who Had an Hgb Level of More Than 13.0 g/dL|Number of participants who had an Hgb increase of more than 13 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have been presented.|Up to Week 52|ITT Population|||Percentage of participants|||Number
2543791|NCT02969655|Secondary|Number of Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks|Number of participants who had an Hgb increase of more than 2 g/dL over any 4 weeks for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users have been presented.|Up to Week 52|ITT Population|||Participants|||Count of Participants
2543792|NCT02969655|Secondary|Number of Participants Who Had an Hgb Level of Less Than 7.5 g/dL|If an initial Hgb value was less than 7.5 g/dL, measurement was repeated at the same study visit (using the same sample) to calculate the average. If the average met the Hgb stopping criteria, study treatment was permanently discontinued. Number of participants who had an Hgb level of less than 7.5 g/dL has been presented.|Up to Week 52|ITT Population|||Percentage of participants|||Number
2543793|NCT02969655|Secondary|Percentage of Time in Hgb Target Range (10.0 to 12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)|Percentage of time in Hgb target range (10.0 to 12.0 g/dL) during the primary efficacy evaluation period (Weeks 40 to 52) for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented.|Weeks 40 to 52|ITT Population. Only those participants with data available at the indicated time point were analyzed.|||Percentage of time||Standard Deviation|Mean
2543794|NCT02969655|Secondary|Percentage of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL) at Each Assessment Visit|Percentage of participants with Hgb within the target range was summarized at each assessment visit by treatment group have been presented.|Baseline (Day 1) and Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Percentage of participants|||Number
2543918|NCT02968979|Secondary|Frequency of Sarcopenia With no Clinical Significant Weight Loss in the General NSCLC Patients With Pre-cachexia|Percentage of patient with sarcopenia and no clinical significant weight loss (sarcopenia and WL< 2%) in the general NSCLC patients with pre-cachexia:|Day 1|Population with no missing data for the 3 interest criteria defining the pre-cachexia|||Participants|||Count of Participants
2543795|NCT02969655|Secondary|Change From Baseline in Hgb Values at Each Assessment Visit|Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calcuated as the post-dose visit value minus the Baseline value. Change from Baseline Hgb values at each assessment visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented.|Baseline (Day 1) and Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||g/dL||Standard Deviation|Mean
2543796|NCT02969655|Secondary|Hgb Values at Each Assessment Visit|Hgb values at each assessment visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented.|Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||g/dL||Standard Deviation|Mean
2543797|NCT02969655|Secondary|Number of Dose Adjustments for Daprodustat|Number of dose adjustments has been presented only for daprodustat.|Up to Week 52|ITT Population. Summary data for Darbepoetin alfa group could not be collected as comparison was not reasonable because of the difference in dose adjustment frequency.|||Dose adjustments||Full Range|Median
2543798|NCT02969655|Secondary|Duration of Treatment Interruption Due to Hgb >13 g/dL|Duration of treatment interruption due to Hgb >13 g/dL for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for the daprodustat group.|Up to Week 52|ITT Population. Only those participants with data available at the time of assessment were used for analysis. Summary data for Darbepoetin alfa group could not be collected as comparison was not reasonable because of the difference in dose adjustment frequency. Median along with inter quartile range (25th and 75th percentile) have been presented.|||Days||Inter-Quartile Range|Median
2543799|NCT02969655|Secondary|Distribution of Darbepoetin Alfa Dose Level by Visit|Distribution of dose level by visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for Darbepoetin Alfa. Median along with the interquartile range (25th and 75th percentile) has been presented.|Day 1, Weeks 2,4,6,8,10,12,14,16,18,20,22,24,26,28,30,32,34,36,38,40,42,44,46,48, and 50|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||micrograms per week (ug/week)||Inter-Quartile Range|Median
2543800|NCT02969655|Secondary|Distribution of Daprodustat Dose Level by Visit|Distribution of dose level by visit for hemodialysis-dependent participants with anemia associated with chronic kidney disease who were currently ESA users has been presented for Daprodustat. Median along with the interquartile range (25th and 75th percentile) has been presented.|Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44, and 48)|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||milligrams per day (mg/day)||Inter-Quartile Range|Median
2543801|NCT02969655|Secondary|Percentage of Participants by Hgb Change From Baseline Category at Week 4|Percentage of participants within each category were provided only for daprodustat and the categories were classified into 6 (i.e., <=-2, >-2 to -1, >-1 to 0, >0 to 1, >1 to 2, >2 grams per deciliter [g/dL]). In addition, 'within 1.0 g/dL (i.e., <=-1 and >=1) and over 2.0 g/dL (i.e., <-2 and >2) categories were provided.|Week 4|ITT Population. Data for Darbepoetin alfa group could not be collected as comparison was not reasonable because of the difference in dose adjustment frequency.|||Percentage of participants|||Number
2543802|NCT02969655|Secondary|Change From Baseline in Hgb (Hgb Increase Rate) at Week 4|Change from Baseline was calculated as the post-dose Week 4 visit value minus the Baseline value.|Baseline and Week 4|ITT Population|||g/dL||Standard Deviation|Mean
2543803|NCT02969655|Secondary|Percentage of Participants With Mean Hgb in the Target Range (10.0-12.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)|The percentage of participants with observed mean Hgb within the target range during the primary efficacy evaluation period was summarized. Odds ratio was estimated using a logistic regression and provided along with its 95% CI and a one-sided p-value.|Weeks 40 to 52|Modified Intent to treat (mITT) comprised of all ITT participants who had at least one Hgb measurement during the evaluation period.|||Percentage of participants|||Number
2543804|NCT02969655|Primary|Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)|The mean hemoglobin during the Evaluation Period was estimated by a statistical model.|Weeks 40 to 52|Intent to treat (ITT) Population comprised of all randomized participants who had a Baseline and at least one post Baseline schedule Hgb assessment.|||Grams per deciliter (g/dL)||Standard Error|Least Squares Mean
2543805|NCT02969590|Primary|Median Cervical Mucus Score - 24 Hour|"Measurement of median cervical mucus scores 24 hours following norethindrone administration. The current clinical standard for appraising cervical mucus is the cervical mucus score (ie. Insler score) that examines mucus based on 5 metrics including volume, spinnbarkeit (stretch), ferning, viscosity and cellularity on a 15-point scale. Per WHO guidelines, scores above 10 are considered mucus favoring penetration and scores below 10 are considered to be unfavorable to penetration."|24 hours|Data from one (1) subject were excluded from analyses because estradiol (E2) levels were consistent with patch noncompliance|||score on a scale||Inter-Quartile Range|Median
2543806|NCT02969590|Primary|Median Cervical Mucus Score - 6 Hour|"Measurement of median cervical mucus scores 6 hours following norethindrone administration. The current clinical standard for appraising cervical mucus is the cervical mucus score (ie. Insler score) that examines mucus based on 5 metrics including volume, spinnbarkeit (stretch), ferning, viscosity and cellularity on a 15-point scale. Per WHO guidelines, scores above 10 are considered mucus favoring penetration and scores below 10 are considered to be unfavorable to penetration."|6 hours|Data from one (1) subject were excluded from analyses because estradiol (E2) levels were consistent with patch noncompliance|||score on a scale||Inter-Quartile Range|Median
2543807|NCT02969590|Primary|Median Cervical Mucus Score - 2 Hour|"Measurement of median cervical mucus scores 2 hours following norethindrone administration. The current clinical standard for appraising cervical mucus is the cervical mucus score (ie. Insler score) that examines mucus based on 5 metrics including volume, spinnbarkeit (stretch), ferning, viscosity and cellularity on a 15-point scale. Per WHO guidelines, scores above 10 are considered mucus favoring penetration and scores below 10 are considered to be unfavorable to penetration."|2 hours|Data from one (1) subject were excluded from analyses because estradiol (E2) levels were consistent with patch noncompliance|||score on a scale||Inter-Quartile Range|Median
2543808|NCT02969590|Secondary|Change in PGRMC1 During Menstrual Cycle|"Measuring the mean transcript change of membrane bound progestin receptors (PGRMC1) from follicular phase to ovulation to luteal phase of spontaneous menstrual cycle.~Total RNA (ribonucleic acid) was isolated from endocervical cell samples and analyzed for expression of PGRMC1 using real-time PCR (polymerase chain reaction) relative to levels of ribosomal (S10) RNA. An endocervical brush will be inserted into the os and then immediately rinsed into a special RNA preserving reagent. After total RNA is isolated and purified, it will be reverse transcribed into cDNA using primers.~Ratio of PGRMC1 to 18s RNA~Gene expression of membrane bound progesterone receptors in endocervical cells"|1 month|"PGRMC1 data was analyzed for the 4 subjects who demonstrate ovarian suppression following leuprolide injection and continued to intervention phase of the study. Outcome was only evaluated during spontaneous menstrual cycle (1 month).~One participant corresponds to one cycle."|||ratio||Standard Deviation|Mean
2543809|NCT02969590|Primary|Sperm Penetration Scores|Measuring sperm penetration scores in different hormonal conditions|Approximately one year|Outcome not analyzed.||||||
2543810|NCT02969590|Primary|Median Cervical Mucus Score - Baseline|"Measurement of median cervical mucus scores at baseline. The current clinical standard for appraising cervical mucus is the cervical mucus score (ie. Insler score) that examines mucus based on 5 metrics including volume, spinnbarkeit (stretch), ferning, viscosity and cellularity on a 15-point scale. Per WHO guidelines, scores above 10 are considered mucus favoring penetration and scores below 10 are considered to be unfavorable to penetration."|Baseline|Data from one (1) subject were excluded from analyses because estradiol (E2) levels were consistent with patch noncompliance|||score on a scale||Inter-Quartile Range|Median
2543811|NCT02969421|Secondary|Provider Satisfaction With Tenaculum Placement|Measured using Likert-type 5 point satisfaction scale dichotomized to optimal (Likert score = 4 or 5) vs suboptimal (Likert score = 1, 2, 3). Reported is the number of participants with optimal grasp.|Directly after tenaculum is placed||||Participants|||Count of Participants
2543812|NCT02969421|Secondary|Overall Pain With Intrauterine Device Insertion|Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.|Directly after intrauterine device is placed||||units on a scale||Inter-Quartile Range|Median
2543813|NCT02969421|Primary|Pain With Tenaculum Placement|Measured using 100-mm visual analog scale. Minimum value 0 meaning no pain and maximum value of 100 meaning worst imaginable pain.|Directly after tenaculum placement||||units on a scale||Inter-Quartile Range|Median
2543814|NCT02969408|Secondary|Number of Participants With Adverse Events (AEs)|AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by investigator. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.|Baseline up to week 12|ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.|||Participants|||Count of Participants
2543815|NCT02969408|Primary|Number of Albuterol Uses in the 24 Hours Preceding a Severe CAE|Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization. Number of albuterol inhalations used in the 24 hours preceeding a severe CAE is reported.|Baseline to Week 12|ITT analysis set included all enrolled participants regardless of whether a participant took any IMP. Here, 'overall number of participants analyzed' signifies number of participants who experienced at least 1 severe CAE and reported albuterol use in the 24 hours preceding a severe CAE.|||inhalations||Standard Deviation|Mean
2543816|NCT02969408|Primary|Number of Days Prior to the Peak of a Severe CAE When Albuterol Use Increased|Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization. Number of days prior to the peak of a severe CAE when albuterol use first increased to greater than (>) 4, >12, and >20 inhalations was reported. Participants were counted in more than 1 category (that is, all of the >20 inhalation participants were also counted in the >12 category, and in the >4 category).|Baseline to Week 12|ITT analysis set included all enrolled participants regardless of whether a participant took any IMP. Here, 'overall number of participants analyzed'= number of participants experiencing at least 1 severe CAE. 'Number analyzed'= participants who had any single day prior to CAE where their albuterol use exceeded 4, 12, or 20 inhalations in that day.|||days||Standard Deviation|Mean
2543817|NCT02969408|Primary|Total Number of Inhalations in the Days Preceding the Peak of a Severe CAE|Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization. Total number of inhalations taken in 1 day (that is, the 24-hour period on the day prior to the date of the CAE symptom peak) and at 3, 5, 7, 10, 14, and 21 days preceding the date of the severe CAE symptom peak were reported.|Baseline to Week 12|ITT analysis set included all enrolled participants regardless of whether a participant took any IMP. Here, 'overall number of participants analyzed' signifies number of participants experiencing at least 1 severe CAE. Here, 'number analyzed' signifies participants who reported albuterol use in specified time interval.|||inhalations||Standard Deviation|Mean
2543919|NCT02968979|Secondary|Frequency of Sarcopenia in the General NSCLC Patients With Cachexia|Percentage of patients with sarcopenia in the general NSCLC patients with cachexia|Day 1|Population with no missing data for the 3 interest criteria defining the cachexia|||Participants|||Count of Participants
2559403|NCT02680054|Primary|Peak Glucose Level Following Test Meal|Glucose measured on the continuous subcutaneous glucose monitor|assessed up to 12 hours following the test meal||||mmol/l||Standard Deviation|Mean
2543818|NCT02969408|Primary|Clinical Asthma Exacerbation (CAE) Rate: Percentage of Participants Who Experienced at Least 1 Moderate or Severe CAE|"CAE was an occurrence of either severe CAE or moderate CAE. Severe CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 milligrams (mg) prednisone equivalent above Baseline, for at least 3 days; and an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization.~Moderate CAE was defined as a CAE that involved worsening asthma such that the treating physician elected to administer prednisone (or equivalent glucocorticoid treatment) at least 10 mg prednisone equivalent above Baseline, for at least 3 days, or an unscheduled provider visit such as an office visit, urgent care visit, emergency care visit, or hospitalization associated with an increase in asthma therapy that did not qualify for severe CAE as defined above."|Baseline (Day 1) to Week 12|ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.|||percentage of participants|||Number
2543819|NCT02969356|Secondary|Change From Baseline in Short Form 12 (SF-12) Scales at Last Study Visit|The SF-12 was a short form questionnaire survey consisting of 12 questions, which were a subset of the SF-36 health survey. Most of the questions were answered based on how the participant had felt over the previous 4 weeks. The SF-12 covers 8 domains, including physical functioning, role-physical, body pain, general health, vitality, social functioning, role-emotional and mental health. The SF-12 questionnaire survey scale ranges from 0-100, where 0= lowest level of health and 100= highest level of health. Positive change from baseline indicates an improvement in QoL.|At last study visit (Week 24 or 40)|The ITT population included all participants who were injected at least once with the study treatment, who received at least 1 day of GSC therapy during the study and for whom a primary TT limb had been defined. Only participants with data available at each time point are presented.|||units on a scale||Standard Deviation|Mean
2543820|NCT02969356|Secondary|Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Scores at Last Study Visit|"Participants were asked to complete EQ-5D-5L questionnaire to assess their current health status. The EQ-5D-5L was a generic, preference-based measure of health-related quality of life (QoL). Questions were answered based on how the participant was feeling Today. The EQ-5D-5L consists of 2 parts: EQ-5D descriptive system and EQ VAS. The EQ-5D descriptive system included questions for each of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The VAS recorded participant's self-rated health on a vertical 20-centimeter VAS where the endpoints were labelled The best health you can imagine and The worst health you can imagine. The EQ-5D-5L questionnaire scores range from 0-100, where 0= worst self-perceived health and 100= best self-perceived health. Positive change from baseline indicates an improvement in QoL."|At last study visit (Week 24 or 40)|The ITT population included all participants who were injected at least once with the study treatment, who received at least 1 day of GSC therapy during the study and for whom a primary TT limb had been defined. Only participants with data available at each time point are presented.|||units on a scale||Standard Deviation|Mean
2543821|NCT02969356|Secondary|Number of Participants Satisfied With a Longer Interval Between 2 Treatment Cycles|"Participants who were not reinjected at Week 12 of a given cycle, recorded their satisfaction with a longer interval between 2 injections collected at the corresponding reinjection visit or the last cycle visit (Week 16 or Week 20 for each cycle). To assess this, the participants were asked the following question: Are you satisfied with a longer interval between 2 injections?. The possible answers were: Yes, No or No opinion."|At reinjection cycle visit (Week 16 or 20) and last study visit (Week 24 or 40)|The ITT population included all participants who were injected at least once with the study treatment, who received at least 1 day of GSC therapy during the study and for whom a primary TT limb had been defined. Results are presented for participants who were not reinjected at Week 12 of the given cycle.|||Participants|||Count of Participants
2543822|NCT02969356|Secondary|Global Assessment of Benefits of the Study Therapy|"A global assessment of the benefits of the study therapy was made by the investigator and the participant (or the caregiver). The participant's caregiver performed the global assessment only in those cases when the participant was not capable to do this. Participants were asked the following question: How would you rate the overall response to study therapy since baseline? Responses on the global assessment were recorded on a 5-level Likert scale, as follows: much better (+2), a bit better (+1), the same (0), a bit worse (-1), and much worse (-2)."|At reinjection cycle visit (Week 12, 16 or 20) and last study visit (Week 24 or 40)|The ITT population included all participants who were injected at least once with the study treatment, who received at least 1 day of GSC therapy during the study and for whom a primary TT limb had been defined. Only participants with data available at each time point are presented.|||units on a scale||Standard Deviation|Mean
2543823|NCT02969356|Secondary|Percentage of Days Over Study Period When GSC Therapy Was Performed|The investigator counted the number of days when GSC therapy was not performed since the last visit. Using the total number of study days and the total number of days when GSC therapy was not performed, the number of days when GSC was performed was calculated.|From baseline to end of the study, up to 280 days|The ITT population included all participants who were injected at least once with the study treatment, who received at least 1 day of GSC therapy during the study and for whom a primary TT limb had been defined.|||percentage of study days||Standard Deviation|Mean
2543824|NCT02969356|Secondary|Change From Baseline in Physiotherapist's Beliefs That the GSC Will Help to Improve Functional Capacity at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit|"Physiotherapists were asked the following question: Do you believe that GSC will help to improve your patient's arm and leg function? Responses were recorded on a 5-level Likert scale, as follows: very true of what I believe (+2), somewhat true of what I believe (+1), no opinion/don't know (0), somewhat untrue of what I believe (-1), and very untrue of what I believe (-2)."|Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit|The ITT population included all participants who were injected at least once with the study treatment, who received at least 1 day of GSC therapy during the study and for whom a primary TT limb had been defined. Only participants with data available at each time point are presented.|||units on a scale||Standard Deviation|Mean
2544339|NCT02962687|Other Pre-specified|Physical Activity|Descriptive analysis of physical activity as measured by the Physical Activity Scale for the Elderly (PASE; range 0 - 360; higher scores are better)|14 weeks|The PASE was administered to the Veteran participants only.|||weighted sum||Standard Deviation|Mean
2543825|NCT02969356|Secondary|Change From Baseline in Participant's Beliefs That the GSC Will Help to Improve Functional Capacity at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit|"Participants were asked the following question: Do you believe that GSC will help to improve your arm and leg function? Responses were recorded on a 5-level Likert scale, as follows: very true of what I believe (+2), somewhat true of what I believe (+1), no opinion/don't know (0), somewhat untrue of what I believe (-1), and very untrue of what I believe (-2)."|Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit|The ITT population included all participants who were injected at least once with the study treatment, who received at least 1 day of GSC therapy during the study and for whom a primary TT limb had been defined. Only participants with data available at each time point are presented.|||units on a scale||Standard Deviation|Mean
2543826|NCT02969356|Secondary|Participant Satisfaction With the GSC at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit|"Each participant received a personalised rehabilitation programme. The physiotherapist taught each participant the stretching postures and exercises to perform on a daily basis throughout the study. These were tailored to the individual participant's needs and formed the GSC therapy. The main focus was on the primary TT limb and then the other limb. Participant satisfaction was determined by asking the question How satisfied are you TODAY regarding the GSC? Responses were recorded using a 5-level Likert scale, as follows: completely satisfied (+2), rather satisfied (+1), neither satisfied nor dissatisfied (0), rather dissatisfied (-1), and completely dissatisfied (-2)."|At baseline (for participants who had GSC previously only), Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit|The ITT population included all participants who were injected at least once with the study treatment, who received at least 1 day of GSC therapy during the study and for whom a primary TT limb had been defined. Only participants with data available at each time point are presented.|||units on a scale||Standard Deviation|Mean
2543827|NCT02969356|Secondary|Mean Change From Baseline in Maximal Walking Speed Barefoot at Week 12 of Each Treatment Cycle and at Last Study Visit|The 10-meter walking speed test (WST) was used to measure active function in the LL. The participant performed the WST barefoot without a walking aid. If it was absolutely necessary that the participant used a cane, this may have been permitted provided that the same cane was used at baseline and all other walking speed assessments for that participant. The participant was given instructions to walk at his/her maximum speed. The time taken for the participant to walk from the start to the end of the 10 meters was recorded.|Week 12 of each treatment cycle and last study visit|The ITT population included all participants who were injected at least once with the study treatment, who received at least 1 day of GSC therapy during the study and for whom a primary TT limb had been defined. Only participants with data available at each time point are presented.|||meters per second||Standard Deviation|Mean
2543828|NCT02969356|Secondary|Mean Change From Baseline in Modified Frenchay Scale (MFS) Overall Score at Week 12 of Each Treatment Cycle and Last Study Visit|"The MFS was used to measure active function in the UL. The MFS consists of 10 tasks, each of which was assessed locally by the site investigator on a 10-point visual analogue scale (VAS) ranging from No movement to Normal. Higher score indicates a better outcome. The MFS overall scores were obtained by averaging all individual task scores, provided that at least 8 out of the 10 were not missing. The mean change from baseline was calculated for the local assessment and a positive change from baseline indicates an improvement in active function."|Week 12 of each treatment cycle and last study visit|The ITT population included all participants who were injected at least once with the study treatment, who received at least 1 day of GSC therapy during the study and for whom a primary TT limb had been defined. Only participants with data available at each time point are presented.|||units on a scale||Standard Deviation|Mean
2543829|NCT02969356|Secondary|Mean Change From Baseline in Full Composite AROM Against 5 UL or 5 LL Muscle Groups, Regardless of Whether the Muscle Groups Were Injected or Not at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit|Full composite AROM, regardless of whether the muscle groups was injected or not was measured by goniometer in the primary TT limb. Full Composite AROM in the UL was calculated as the sum of the AROM in the 5 UL muscle groups (SE+EF+WF+FF+PT). Full Composite AROM in the LL was calculated as the sum of the AROM in the 5 LL muscle groups (Sol+GN+GM+HS+RF).|Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit|The ITT population included all participants who were injected at least once with the study treatment, who received at least 1 day of GSC therapy during the study and for whom a primary TT limb had been defined. Only participants with data available at each time point are presented.|||degrees||Standard Deviation|Mean
2543830|NCT02969356|Secondary|Mean Change From Baseline in Composite AROM Against Injected Muscle Groups (Any of the 10 Prespecified Muscles) at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit|Composite AROM (XA) was measured by goniometer in the primary TT limb (either UL or LL, depending on which one has been selected as the primary TT limb), composite AROM in the UL injected muscle groups was calculated as the sum of the AROM in the EF, WF and FF. Composite AROM in the LL injected muscle groups was calculated as the sum of the AROM in Sol and GN.|Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit|The ITT population included all participants who were injected at least once with the study treatment, who received at least 1 day of GSC therapy during the study and for whom a primary TT limb had been defined. Only participants with data available at each time point are presented.|||degrees||Standard Deviation|Mean
2543840|NCT02969317|Primary|Maximum Measured Concentration of Tiotropium in Plasma at Steady State (Cmax,ss)|Cmax,ss, maximum measured concentration of olodaterol in plasma at steady state of Tiotropium after multiple dosing at Visit 4 of tiotropium+olodaterol FDC 5 mg/5 mg is presented as unadjusted geometric mean (gMean) and geometric coefficient of variation (gCV) (%).|Day 21: 0:15 (hours:minutes) before drug administration and 0:02, 0:05, 0:07, 0:10, 0:20, 0:30, 0:40, 1:00, 2:00, 3:00, 4:00, 6:00, 12:00, 24:00 (hours:minutes) after drug administration|PKS (evaluable cases)|||Picograms per millilitre [pg/mL]||Geometric Coefficient of Variation|Geometric Mean
2543920|NCT02968979|Secondary|Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Histology Associated With NSCLC.|Percentage of the different stages of cachexia according to the NSCLC histology|Day 1|Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) Missing data for 84 patients|||Participants|||Count of Participants
2543831|NCT02969356|Secondary|Mean Change From Baseline in AROM Against 10 Prespecified Muscle Groups at Week 6 and Week 12 of Each Treatment Cycle, Reinjection Cycle Visit and Last Study Visit|The AROM was measured by goniometer in the primary TT limb, using zero as the theoretical position of minimal stretch for the muscle assessed. Participants were asked to perform the active movement as far as possible against that muscle and the angle was measured. The angle of joint movement was measured in 10 prespecified muscle groups (injected or noninjected); UL: shoulder extensors (SE), elbow flexors (EF), wrist flexors (WF), extrinsic finger flexors (FF) and pronator teres (PT), LL: soleus (Sol), gastrocnemius (GN), gluteus maximus (GM), hamstrings (HS) and rectus femoris (RF). The reinjection cycle visit corresponds to Week 12, 16 or 20 of injection Cycle 1. The last study visit corresponds to the last post-baseline visit performed by the participant (including the early withdrawal visit).|Week 6 and Week 12 of each treatment cycle, reinjection cycle visit and last study visit|The ITT population included all participants who were injected at least once with the study treatment, who received at least 1 day of GSC therapy during the study and for whom a primary TT limb had been defined. Only participants with data available at each time point are presented.|||degrees||Standard Deviation|Mean
2543832|NCT02969356|Secondary|Percentage of Responder Participants at Week 6 After the First Injection, According to Composite AROM in the Primary TT Limb|Percentage of responder participants according to composite AROM was measured by goniometer in the primary TT limb, using zero as the theoretical position of minimal stretch for the muscle assessed. Participants were asked to perform the active movement as far as possible against that muscle and the angle was measured. A participant was considered a responder if he/she achieved at least the predefined improvement threshold - larger or equal to 35 degrees in UL or 5 degrees in LL - in the primary TT limb (based on the composite AROM individual change from baseline to Week 6 after the first injection).|At Week 6, Cycle 1|The ITT population included all participants who were injected at least once with the study treatment, who received at least 1 day of GSC therapy during the study and for whom a primary TT limb had been defined.|||percentage of participants||95% Confidence Interval|Number
2543833|NCT02969356|Primary|Percentage of Responder Participants at Week 6 After the Second Injection, According to Composite Active Range of Motion (AROM) in the Primary TT Limb|Percentage of responder participants according to AROM was measured by goniometer in the primary TT limb, using zero as the theoretical position of minimal stretch for the muscle assessed. Participants were asked to perform the active movement as far as possible against that muscle and the angle was measured. A participant was considered a responder if he/she achieved at least the predefined improvement threshold - larger or equal to 35 degrees in UL or 5 degrees in LL - in the primary TT limb (based on the composite AROM individual change from baseline to Week 6 after the second injection).|At Week 6, Cycle 2|The modified ITT (mITT) population included all participants who were injected at least once with the study treatment, who received at least 1 day of GSC therapy during the study, for whom a primary TT limb had been defined and who had the primary efficacy outcome assessed at Week 6, Cycle 2.|||percentage of participants||95% Confidence Interval|Number
2543834|NCT02969317|Primary|Accumulation Ratios in Plasma of Tiotropium (RA,AUC =AUC0-6,ss/AUC0-6)|Regarding AUC0-6 and RA,AUC0-6, the descriptive statistics of AUC0-6 could not be evaluated. Since the plasma concentrations of olodaterol and tiotropium was only quantifiable in less than two-thirds of the patients after 4 hours and 1 hour, respectively, and the descriptive statistics is calculated in case that 2/3 patients of total could be evaluated as defined in CTP. And RA,AUC0-6 is the ratio of AUC0-6,ss to AUC0-6. So, the descriptive RA,AUC0-6 was not calculated either.|Day 1 and Day 21|PKS (evaluable cases)||||||
2543835|NCT02969317|Primary|Accumulation Ratios in Plasma of Tiotropium (RA,Cmax =Cmax,ss/Cmax)|Accumulation ratios in plasma of Tiotropium (RA,Cmax =Cmax,ss/Cmax) after multiple dosing at Visit 4 is presented as unadjusted geometric mean (gMean) and geometric coefficient of variation (gCV) (%).|Day 1, 7, 14, 18, 19, 20 and 21|PKS (evaluable cases)|||ratio||Geometric Coefficient of Variation|Geometric Mean
2543836|NCT02969317|Primary|Time From Dosing to the Maximum Concentration of Tiotropium in Plasma at Steady State (Tmax,ss)|Tmax,ss,time from dosing to the maximum concentration of Tiotropium in plasma at steady state after multiple dosing at Visit 4 of tiotropium+olodaterol FDC 5 mg/5 mg is presented as unadjusted geometric mean (gMean) and geometric coefficient of variation (gCV) (%).|Day 21: 0:15 (hours:minutes) before drug administration and 0:02, 0:05, 0:07, 0:10, 0:20, 0:30, 0:40, 1:00, 2:00, 3:00, 4:00, 6:00, 12:00, 24:00 (hours:minutes) after drug administration|PKS (evaluable cases)|||Hour [h]||Full Range|Median
2543837|NCT02969317|Primary|Area Under the Concentration-time Curve of Tiotropium in Plasma at Steady State Over a Uniform Dosing Interval τ at Steady State (AUCτ,ss)|AUCτ,ss, area under the concentration-time curve of Tiotropium in plasma at steady state over a uniform dosing interval τ at steady state after multiple dosing at Visit 4 is presented as unadjusted geometric mean (gMean) and geometric coefficient of variation (gCV) (%).|Day 21: 0:15 (hours:minutes) before drug administration and 0:02, 0:05, 0:07, 0:10, 0:20, 0:30, 0:40, 1:00, 2:00, 3:00, 4:00, 6:00, 12:00, 24:00 (hours:minutes) after drug administration|PKS (evaluable cases)|||Picograms*hour per millilitre [pg*h/mL]||Geometric Coefficient of Variation|Geometric Mean
2543838|NCT02969317|Primary|Area Under the Concentration Time Curve of Tiotropium in Plasma Over the Time Interval From 0 to 6 Hours at Steady State (AUC0-6,ss)|AUC0-6,ss, area under the concentration time curve of Tiotropium in plasma over the time interval from 0 to 6 hours at steady state after multiple dosing at Visit 4 of tiotropium+olodaterol FDC 5 mg/5 mg is presented as unadjusted geometric mean (gMean) and geometric coefficient of variation (gCV) (%).|Day 21:0:15 (hours:minutes) before drug administration and 0:02, 0:05, 0:07, 0:10, 0:20, 0:30, 0:40, 1:00, 2:00, 3:00, 4:00, 6:00 (hours:minutes) after drug administration|PKS (evaluable cases)|||Picograms*hour per millilitre [pg*h/mL]||Geometric Coefficient of Variation|Geometric Mean
2543839|NCT02969317|Primary|Pre-dose Concentration of Tiotropium in Plasma at Steady State (Cpre,ss)|Cpre,ss, pre-dose concentration of Tiotropium in plasma at steady state after multiple dosing at Visit 4 of tiotropium+olodaterol FDC 5 mg/5 mg is presented as unadjusted geometric mean (gMean) and geometric coefficient of variation (gCV) (%).|Day 21: 0:15 (hours:minutes) before drug administration and 0:02, 0:05, 0:07, 0:10, 0:20, 0:30, 0:40, 1:00, 2:00, 3:00, 4:00, 6:00, 12:00, 24:00 (hours:minutes) after drug administration|PKS (evaluable cases)|||Picograms per millilitre [pg/mL]||Geometric Coefficient of Variation|Geometric Mean
2546802|NCT02915978|Secondary|Number of Participants Using Rescue Analgesia Over 0 to 24 Hours and Over 0 to 48 Hours||Over 0 to 24 hours; Over 0 to 48 hours|All randomized participants from the Intent-to-Treat (ITT) population.|||Participants|||Count of Participants
2543841|NCT02969317|Primary|Maximum Measured Concentration of Tiotropium in Plasma (Cmax)|"Cmax, maximum measured concentration of Tiotropium in plasma after single inhaled administration of tiotropium+olodaterol FDC 5 mg/5 mg is presented as unadjusted geometric mean (gMean) and geometric coefficient of variation (gCV) (%).~Detailed sampling time points:0:05 (hours:minutes) before drug administration and 0:02, 0:05, 0:07, 0:10, 0:20, 0:30, 0:40, 1:00, 2:00, 3:00, 4:00, 6:00, 143:45, 144:20, 311:45, 312:20, 407:45, 408:20, 431:45, 432:20, 455:45, 456:20 (hours:minutes) after drug administration"|Day 1, 7, 14, 18, 19, 20|PKS (evaluable cases)|||Picograms per millilitre [pg/mL]||Geometric Coefficient of Variation|Geometric Mean
2543842|NCT02969317|Primary|Time From Dosing to the Maximum Concentration of Tiotropium in Plasma (Tmax)|"Tmax, time from dosing to the maximum concentration of Tiotropium in plasma after single inhaled administration of tiotropium+olodaterol FDC 5 mg/5 mgis presented as unadjusted geometric mean (gMean) and geometric coefficient of variation (gCV) (%).~Detailed sampling time points:0:05 (hours:minutes) before drug administration and 0:02, 0:05, 0:07, 0:10, 0:20, 0:30, 0:40, 1:00, 2:00, 3:00, 4:00, 6:00, 143:45, 144:20, 311:45, 312:20, 407:45, 408:20, 431:45, 432:20, 455:45, 456:20 (hours:minutes) after drug administration"|Day 1, 7, 14, 18, 19, 20|PKS (evaluable cases)|||Hour [h]||Full Range|Median
2543843|NCT02969317|Primary|Area Under the Concentration Time Curve of Tiotropium in Plasma Over the Time Interval From 0 to 6 Hours After Drug Administration (AUC0-6)|The descriptive statistics of AUC0-6 could not be evaluated. Since the plasma concentrations of olodaterol and tiotropium was only quantifiable in less than two-thirds of the patients after 4 hours and 1 hour, respectively, and the descriptive statistics is calculated in case that 2/3 patients of total could be evaluated as defined in Clinical trial Protocol (CTP).|Day 1|PKS (evaluable cases)||||||
2543844|NCT02969317|Primary|Accumulation Ratios in Plasma of Olodaterol (RA,AUC =AUC0-6,ss/AUC0-6)|Regarding AUC0-6 and RA,AUC0-6, the descriptive statistics of AUC0-6 could not be evaluated. Since the plasma concentrations of olodaterol and tiotropium was only quantifiable in less than two-thirds of the patients after 4 hours and 1 hour, respectively, and the descriptive statistics is calculated in case that 2/3 patients of total could be evaluated as defined in Clinical trial Protocol (CTP). And RA,AUC0-6 is the ratio of AUC0-6,ss to AUC0-6. So, the descriptive RA,AUC0-6 was not calculated either.|Day 1 and Day 21|PKS (evaluable cases)||||||
2543845|NCT02969317|Primary|Accumulation Ratios in Plasma of Olodaterol (RA,Cmax =Cmax,ss/Cmax)|Accumulation ratios in plasma of olodaterol (RA,Cmax =Cmax,ss/Cmax) after multiple dosing at Day 21 is presented as unadjusted geometric mean (gMean) and geometric coefficient of variation (gCV) (%).|Day 1 and Day 21|PKS (evaluable cases)|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2543846|NCT02969317|Primary|Time From Dosing to the Maximum Concentration of Olodaterol in Plasma at Steady State (Tmax,ss)|Tmax,ss,time from dosing to the maximum concentration of olodaterol in plasma at steady state after multiple dosing at Day 21 of tiotropium+olodaterol FDC 5 mg/5 mg is presented as unadjusted geometric mean (gMean) and geometric coefficient of variation (gCV) (%).|Day 21: 0:15 (hours:minutes) before drug administration and 0:02, 0:05, 0:07, 0:10, 0:20, 0:30, 0:40, 1:00, 2:00, 3:00, 4:00, 6:00, 12:00, 24:00 (hours:minutes) after drug administration|PKS (evaluable cases)|||Hour [h]||Full Range|Median
2543847|NCT02969317|Primary|Area Under the Concentration-time Curve of Olodaterol in Plasma at Steady State Over a Uniform Dosing Interval τ at Steady State (AUCτ,ss)|AUCτ,ss, area under the concentration-time curve of olodaterol in plasma at steady state over a uniform dosing interval τ at steady state after multiple dosing at Day 21 is presented as unadjusted geometric mean (gMean) and geometric coefficient of variation (gCV) (%).|Day 21: 0:15 (hours:minutes) before drug administration and 0:02, 0:05, 0:07, 0:10, 0:20, 0:30, 0:40, 1:00, 2:00, 3:00, 4:00, 6:00, 12:00, 24:00 (hours:minutes) after drug administration|PKS (evaluable cases)|||Picograms*hour per millilitre [pg*h/mL]||Geometric Coefficient of Variation|Geometric Mean
2543848|NCT02969317|Primary|Area Under the Concentration Time Curve of Olodaterol in Plasma Over the Time Interval From 0 to 6 Hours at Steady State (AUC0-6,ss)|AUC0-6,ss, area under the concentration time curve of olodaterol in plasma over the time interval from 0 to 6 hours at steady state after multiple dosing at Day 21 of tiotropium+olodaterol FDC 5 mg/5 mg is presented as unadjusted geometric mean (gMean) and geometric coefficient of variation (gCV) (%).|Day 21: 0:15 (hours:minutes) before drug administration and 0:02, 0:05, 0:07, 0:10, 0:20, 0:30, 0:40, 1:00, 2:00, 3:00, 4:00, 6:00 (hours:minutes) after drug administration|PKS (evaluable cases)|||Picograms*hour per millilitre [pg*h/mL]||Geometric Coefficient of Variation|Geometric Mean
2543849|NCT02969317|Primary|Pre-dose Concentration of Olodaterol in Plasma at Steady State (Cpre,ss)|Cpre,ss, pre-dose concentration of olodaterol in plasma at steady state after multiple dosing at Day 21 of tiotropium+olodaterol FDC 5 mg/5 mg is presented as unadjusted geometric mean (gMean) and geometric coefficient of variation (gCV) (%).|Day 21: 0:15 (hours:minutes) before drug administration and 0:02, 0:05, 0:07, 0:10, 0:20, 0:30, 0:40, 1:00, 2:00, 3:00, 4:00, 6:00, 12:00, 24:00 (hours:minutes) after drug administration|PKS (evaluable cases)|||Picograms per millilitre [pg/mL]||Geometric Coefficient of Variation|Geometric Mean
2543850|NCT02969317|Primary|Maximum Measured Concentration of Olodaterol in Plasma at Steady State (Cmax,ss)|Cmax,ss, maximum measured concentration of olodaterol in plasma at steady state of olodaterol after multiple dosing at Visit 4 (day 21) of tiotropium+olodaterol FDC 5 mg/5 mg is presented as unadjusted geometric mean (gMean) and geometric coefficient of variation (gCV) (%).|Day 21: 0:15 (hours:minutes) before drug administration and 0:02, 0:05, 0:07, 0:10, 0:20, 0:30, 0:40, 1:00, 2:00, 3:00, 4:00, 6:00, 12:00, 24:00 (hours:minutes) after drug administration|PKS (evaluable cases)|||Picograms per millilitre [pg/mL]||Geometric Coefficient of Variation|Geometric Mean
2543851|NCT02969317|Primary|Maximum Measured Concentration of Olodaterol in Plasma (Cmax)|"Cmax, maximum measured concentration of olodaterol in plasma after single inhaled administration of tiotropium+olodaterol FDC 5 mg/5 mg is presented as unadjusted geometric mean (gMean) and geometric coefficient of variation (gCV) (%).~detailed sampling time points: 0:05 (hours:minutes) before drug administration and 0:02, 0:05, 0:07, 0:10, 0:20, 0:30, 0:40, 1:00, 2:00, 3:00, 4:00, 6:00, 143:45, 144:20, 311:45, 312:20, 407:45, 408:20, 431:45, 432:20, 455:45, 456:20(hours:minutes) after drug administration."|Day 1, 7, 14, 18, 19 and 20|PKS (evaluable cases)|||Picograms per millilitre [pg/mL]||Geometric Coefficient of Variation|Geometric Mean
2543921|NCT02968979|Secondary|Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Stage Associated With NSCLC.|Percentage of the different stages of cachexia at inclusion according to the NSCLC stage|Day 1|Patients,18 years and older, with Non Small Cell Lung Cancer (NSCLC) Missing data for 81 patients|||Participants|||Count of Participants
2543852|NCT02969317|Primary|Time From Dosing to the Maximum Concentration of Olodaterol in Plasma (Tmax)|"Tmax, time from dosing to the maximum concentration of olodaterol in plasma after single inhaled administration of tiotropium+olodaterol FDC 5 mg/5 mg is presented as unadjusted geometric mean (gMean) and geometric coefficient of variation (gCV) (%).~detailed sampling time points: 0:05 (hours:minutes) before drug administration and 0:02, 0:05, 0:07, 0:10, 0:20, 0:30, 0:40, 1:00, 2:00, 3:00, 4:00, 6:00, 143:45, 144:20, 311:45, 312:20, 407:45, 408:20, 431:45, 432:20, 455:45, 456:20(hours:minutes) after drug administration."|Day 1, 7, 14, 18, 19 and 20|PKS (evaluable cases)|||Hour [h]||Full Range|Median
2543853|NCT02969317|Primary|Area Under the Concentration Time Curve of Olodaterol in Plasma Over the Time Interval From 0 to 6 Hours After Drug Administration (AUC0-6)|The descriptive statistics of AUC0-6 could not be evaluated. Since the plasma concentrations of olodaterol and tiotropium was only quantifiable in less than two-thirds of the patients after 4 hours and 1 hour, respectively, and the descriptive statistics is calculated in case that 2/3 patients of total could be evaluated as defined in Clinical trial Protocol (CTP).|0:05 (hours:minutes) before drug administration and 0:02, 0:05, 0:07, 0:10, 0:20, 0:30, 0:40, 1:00, 2:00, 3:00, 4:00, 6:00 (hours:minutes) after drug administration|Pharmacokinetic analysis set (PKS): This set included all patients in the treated set with at least one evaluable PK parameter in the treatment period without important protocol violations related to PK||||||
2543854|NCT02969187|Secondary|Cumulative Nausea Score|"Description: We used a time weight average (TWA) method in adjusting the nausea score.~Cumulative nausea score through 72 hours after surgery is the summation of all the time weight average nausea scores with a range from 68-272.~The high score represents the worse outcomes. 68 means no nausea during the whole time and 272 means severe nausea during the whole time."|Nausea assessed when the patient is admitted to the recovery room after surgery, every 8 hrs thereafter for up to 72 hours post operatively||||score on a scale||Standard Deviation|Mean
2543855|NCT02969187|Secondary|Cumulative Pain Score Through 48 Hours After Surgery|"Description: We used a time weight average (TWA) pain score in frequent measurements of pain score.~Cumulative pain score through 48 hours after surgery is the summation of all the time weight average pain scores with a range from 0 to 440.~The high score represents the worse outcomes. 0 means no pain during the whole time and 440 means severe pain during the whole time."|Pain assessed when the patient is admitted to the recovery room after surgery, every 8 hrs thereafter for up to 48 hours post operatively||||score on a scale||Standard Deviation|Mean
2543856|NCT02969187|Primary|Total Amount of Opioids at 48 Hours|The total amount of opioids used will be recorded from the nurse chart.|At 48 hours post operative|A total of 126 patients were randomized in this study. Out of that, 25 patients were excluded due either inadequate data, not prescribed post-operative ketorolac or intraoperative additional procedures performed. A total of 101 patients were included;|||mg||Standard Deviation|Mean
2543857|NCT02969044|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index [HAQ-DI] at Week 1, 2, 4, 6 and 8|HAQ-DI assess degree of difficulty a participant experienced (during past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: average of the sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.|Baseline, Week 1, 2, 4, 6 and 8|ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.|||units on a scale||Standard Deviation|Mean
2543858|NCT02969044|Secondary|Change From Baseline in Participant's Assessment of Arthritis Pain (PAAP), Participant's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 1, 2, 4, 6 and 8|"PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, Considering all the ways your arthritis affects you, how are you feeling today? and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity."|Baseline, Week 1, 2, 4, 6 and 8|ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.|||units on a scale||Standard Deviation|Mean
2543859|NCT02969044|Secondary|Change From Baseline in the Tender Joint Count and Swollen Joint Count at Week 1, 2, 4, 6 and 8|Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.|Baseline, Week 1, 2, 4, 6 and 8|ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.|||joint count||Standard Deviation|Mean
2543860|NCT02969044|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Concentration at Week 1, 2, 4, 6 and 8||Baseline, Week 1, 2, 4, 6 and 8|ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.|||milligram per deciliter||Standard Deviation|Mean
2543886|NCT02969018|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI50) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16|A PASI50 response is a 50% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.|Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16|All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data for each specified time point after non-responder imputation applied.|||percentage of participants||90% Confidence Interval|Number
2543861|NCT02969044|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 1, 2, 4, 6 and 8|DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity.|Baseline, Week 1, 2, 4, 6 and 8|ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.|||units on a scale||Standard Deviation|Mean
2543862|NCT02969044|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6 and 8|DAS28 is measure of disease activity in participants. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Baseline, Week 1, 2, 4, 6 and 8|ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.|||units on a scale||Standard Deviation|Mean
2543863|NCT02969044|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 1, 2, 4, 6 and 8|DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Baseline, Week 1, 2, 4, 6 and 8|ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.|||units on a scale||Standard Deviation|Mean
2543864|NCT02969044|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) at Week 1, 2, 4, 6 and 8|DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and ESR (mm/hr). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.|Baseline, Week 1, 2, 4, 6 and 8|ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.|||units on a scale||Standard Deviation|Mean
2543865|NCT02969044|Secondary|Remission Rate Based on Disease Activity Score (DAS28-4 [CRP])|Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP): calculated from SJC, TJC, CRP (mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity.|Week 4, 6 and 8|ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).|||percentage of participants|||Number
2543866|NCT02969044|Secondary|Remission Rate Based on Disease Activity Score (DAS28-3 [CRP])|Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.|Week 4, 6 and 8|ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).|||percentage of participants|||Number
2543867|NCT02969044|Secondary|Remission Rate Based on Disease Activity Score (DAS28-4[ESR])|Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from the number of SJC and TJC using the 28 joints count, the ESR (mm/hour) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission.|Week 4, 6 and 8|ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).|||percentage of participants|||Number
2543868|NCT02969044|Secondary|Remission Rate Based on Disease Activity Score (DAS28-3 [ESR])|Remission rate was defined as the percentage of participants with disease remission. DAS28 is measure of disease activity in participants with rheumatoid arthritis. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, and erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) <2.6 = remission.|Week 4, 6 and 8|ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).|||percentage of participants|||Number
2543917|NCT02968979|Secondary|Frequency of the Different Stages of Cachexia in the General NSCLC Population According to Molecular Abnormalities Associated With NSCLC.|"Percentage of the different stages of cachexia according to the molecular abnormalities associated with NSCLC:~EGRF, ALK, ROS1, BRAF or HER2~K-RAS~No mutation"|Day 1|NSCLC patients Overall number of patients analyzed for cachexia stage; 244 missing data.|||Participants|||Count of Participants
2543869|NCT02969044|Secondary|Remission Rate Based on Simple Disease Activity Index Score|Remission rate was defined as percentage of participants with disease remission. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Week 4, 6 and 8|ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo).|||percentage of participants|||Number
2543870|NCT02969044|Secondary|Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 1, 2, 4 and 6|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores=greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score= 0 to 86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Baseline, Week 1, 2, 4 and 6|ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.|||units on a scale||Standard Deviation|Mean
2543871|NCT02969044|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 12 that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Week 12|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2543872|NCT02969044|Secondary|Number of Participants With Laboratory Abnormalities|Hemoglobin(Hb);hematocrit;RBC count:<0.8*lower limit of normal (LLN),mean corpuscular volume;mean corpuscular Hb concentration:<0.9*LLN or>1.1*upper limit of normal (ULN), platelet:<0.5*LLN or >1.75*ULN,reticulocytes <0.5*LLN or >1.5*ULN,leukocytes <0.6*LLN or >1.5*ULN,lymphocyte;neutrophil: <0.8*LLN or >1.2*ULN,basophil;eosinophil; monocyte:>1.2*ULN,partial thromboplastin time,prothrombin time>1.1*ULN,bilirubin>1.5*ULN, aspartate aminotransferase; alanine aminotransferase;alkaline phosphatase:>3.0*ULN,protein;albumin;LDL, HDL cholesterol:<0.8*LLN or >1.2*ULN;urea nitrogen;creatinine: >1.3*ULN, urate >1.2*ULN, sodium<0.95*LLN or >1.05*ULN, potassium; chloride;calcium; bicarbonate:<0.9*LLN or >1.1*ULN,glucose <0.6*LLN or >1.5*ULN, creatine kinase: >2.0*ULN;urine pH <4.5 or >8,urine glucose or ketones>=1,urine protein;urineHb>=1,urobilinogen;bilirubin;nitrite;leukocyte esterase >=1,urine erythrocytes, leukocytes>=20,hyaline cast>1,bacteria>20.|Baseline up to Week 12|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2543873|NCT02969044|Secondary|Number of Participants With Vital Signs Abnormalities|Criteria: sitting pulse rate less than (<) 40 beats per minute (bpm) or >120 bpm; sitting systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg) change from baseline in same posture or <90 mmHg; diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or <50 mmHg. Only those categories in which at least one participant had abnormality, were reported in this outcome measure.|Baseline up to Week 12|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2543874|NCT02969044|Primary|Change From Baseline in Simple Disease Activity Index (SDAI) Score at Week 8|The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on a visual analogue scale (VAS) scale ranging from 0 to 10 centimeter (cm), where higher scores=greater affection due to disease activity, and C-reactive protein (CRP) measured in terms of milligram per deciliter (mg/dL). SDAI total score= 0 to 86. SDAI greater than or equal to (<=) 3.3 indicates disease remission, greater than (>) 3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Baseline, Week 8|ITT analysis set included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (PF-06651600 or placebo). Here, n signifies number of participants evaluable at specified time points only.|||units on a scale||Standard Deviation|Mean
2543875|NCT02969031|Secondary|Empathic Response to Patient Expressions of Negative Emotions|"What does the outcome measure? The outcome measures the construct of a physician's skill at providing appropriate empathic responses to patient's expressions of emotional concerns. The measure is the ratio of the number of empathic responses to the total empathic opportunities that occur during a provider-patient encounter.~How is the outcome measured? The provider-patient encounters are audio recorded. Trained listeners review, score and code the physician responses from the audio-recorded conversations. This code indicates an empathic opportunity. Behaviors that represent appropriate empathic responses are also coded."|6 months||||# empathic responses/# empathic opportun||Standard Deviation|Mean
2543876|NCT02969031|Primary|Provider to Patient Communication Score|The score measures the construct of patient's perception of attentive response by the medical oncologist during recalled office encounters over 12 months. Patients completed the Clinician Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS©) Version 1.0 questionnaire via computer or phone Interactive Voice Response (IVR) system.The Provider to Patient Communication Score:(1) Provider explained things in a way that was easy to understand (2) Provider listened carefully to patient (3) Provider showed respect for what patient had to say (4) Provider spent enough time with patient. Coded as 1 (Yes, definitely), 2 (Yes, somewhat), 3 (No), or 4 (I prefer not to answer).Obtained aggregate score ((1) to (3) above), calculated avg. of the scores to each question. Avgs. modeled with linear mixed-effect model. Analyzed data in both cases where a) missing responses are dropped from data and b) missing responses are kept in dataset. Lower score indicates more desirable outcome.|6 months||||score on a scale||Standard Deviation|Mean
2543934|NCT02968758|Secondary|Unresolved Sample Results|To estimate the rate of unresolved results for the GenePOC CDiff System due to Sample Processing control failure (unresolved sample results).|At the time of the results with Reference Method is confirmed, up to 3 months||||percentage of Unresolved||95% Confidence Interval|Number
2543877|NCT02969018|Secondary|Number of Participants With Post-Baseline Electrocardiogram (ECG) Abnormalities|ECG categorical summarization criteria: 1) QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): >=140 milliseconds (msec), >=50% change from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% change when baseline is > 200 msec or >=50% change when baseline is less than or equal to (<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of >=500 msec; 4) QTc interval (QT corrected for heart rate): absolute value of 450 to <480 msec, 480 to <500 msec, >=500 msec; a change from baseline of 30 to <60 msec or >=60 msec.|From first dose of study treatment (Day 1) up to Week 16|All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had post-baseline ECG data.|||Participants|||Count of Participants
2543878|NCT02969018|Secondary|Number of Participants With Post-Baseline Vital Sign Abnormalities|Vital signs categorical summarization criteria: 1) sitting systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) sitting diastolic blood pressure (DBP) <50 mmHg; 3) sitting pulse rate <40 or >120 beats per minute (bpm); 4) change from baseline (increase or decrease) in sitting DBP greater than or equal to (>=) 20 mmHg; 5) change from baseline (increase or decrease) in sitting SBP >=30 mmHg.|From first dose of study treatment (Day 1) up to Week 16|All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had post-baseline vital signs data.|||Participants|||Count of Participants
2543879|NCT02969018|Secondary|Number of Participants With Any Post-Baseline Laboratory Test Abnormalities|Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time [PT], PT/international normalized ratio; chemistry (total bilirubin, direct bilirubin, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, alkaline phosphatase, protein, albumin, urea nitrogen, creatinine, urate, total cholesterol, LDL and HDL cholesterol, triglycerides, calcium, sodium, potassium, chloride, bicarbonate, glucose, creatine kinase, Cystatin C, glomerular filtration rate; urinalysis (pH, urine glucose, ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, bacteria, choriogonadotropin beta).|From first dose of study treatment (Day 1) up to Week 16|All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had post-baseline laboratory data.|||Participants|||Count of Participants
2543880|NCT02969018|Secondary|Change From Baseline in Blood Lipid Level at Weeks 4 and 12|Lipid panel included low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, total cholesterol, and triglycerides.|Baseline (Day 1 pre-dose), Weeks 4 and 12|"Number of participants analyzed represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo). Number analyzed represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had data for each specified category."|||milligram per deciliter (mg/dL)||90% Confidence Interval|Mean
2543881|NCT02969018|Secondary|Number of Participants Who Discontinued From the Study Due to Treatment-Emergent AEs|The number of participants who discontinued from the study due to treatment-emergent AEs is presented. Note for data reported under this Outcome Measure: Per sponsor reporting standard, pregnancy was counted as AE for AE data tables while it was counted separately in the disposition data table (Participant Flow Module).|From first dose of study treatment (Day 1) up to Week 20|All participants who received at least 1 dose of investigational product (PF-06700841 or placebo).|||Participants|||Count of Participants
2543882|NCT02969018|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE (non-serious and serious) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or an important medical event. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.|From first dose of study treatment (Day 1) up to Week 20|All participants who received at least 1 dose of investigational product (PF-06700841 or placebo).|||Participants|||Count of Participants
2543883|NCT02969018|Secondary|Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16|The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.|Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16|"”Number of participants analyzed represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo). ”Number analyzed represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had observed PASI data for each specified time point."|||percent change||90% Confidence Interval|Mean
2543884|NCT02969018|Secondary|Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6, 8, 10, 14, 16|The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.|Baseline (Day 1 pre-dose), Weeks 1, 2, 4, 6, 8, 10, 14, 16|"”Number of participants analyzed represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo). ”Number analyzed represents all participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had observed PASI data for each specified time point."|||units on a scale||90% Confidence Interval|Mean
2543885|NCT02969018|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI90) Response at Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16|A PASI90 response is a 90% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.|Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16|All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data for each specified time point after non-responder imputation applied.|||percentage of participants||90% Confidence Interval|Number
2544052|NCT02966275|Secondary|Number of Carbohydrate Interventions for Hypoglycemia Per Day|Number of carbohydrate interventions for hypoglycemia per day calculated from daily email survey|14 days||||interventions/day||Standard Deviation|Mean
2543887|NCT02969018|Secondary|Percentage of Participants Achieving PASI75 Responses at Weeks 1, 2, 4, 6, 8, 10, 14, 16|A PASI75 response is a 75% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.|Weeks 1, 2, 4, 6, 8, 10, 14, 16|All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data for each specified time point after non-responder imputation applied.|||percentage of participants||90% Confidence Interval|Number
2543888|NCT02969018|Secondary|Change From Baseline in PASI Scores at Week 4 by Induction Dose|Change from baseline in PASI scores at Week 4 was presented by induction dose (ie, PF-06700841 60 mg QD, 30 mg QD, and placebo). The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.|Baseline (Day 1 pre-dose), Week 4|All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had observed PASI data at Week 4.|||units on a scale||90% Confidence Interval|Least Squares Mean
2543889|NCT02969018|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12|A PASI75 response is a 75% or greater reduction from baseline in PASI score. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.|Week 12|All participants who received at least 1 dose of investigational product (PF-06700841 or placebo) with PASI data at Week 12 after non-responder imputation applied.|||percentage of participants||90% Confidence Interval|Number
2543890|NCT02969018|Primary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. In each area, the sum of the severity rating scores for erythema, induration and scaling is multiplied by the score representing the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of the numbers obtained for each of the four body areas is the PASI. The PASI score can vary in increments of 0.1 units from 0.0 to 72.0, with higher scores representing increasing severity of psoriasis.|Baseline (Day 1 pre-dose), Week 12|All randomized participants who received at least 1 dose of investigational product (PF-06700841 or placebo) and had observed PASI data for Week 12.|||units on a scale||90% Confidence Interval|Least Squares Mean
2543891|NCT02968992|Secondary|Physical Strength as Measured by Grip Strength|Hand grip strength is measured by the amount of static force that the hand can squeeze around a dynamometer. An administrator recorded the reading on the device. The force was measured in kilograms.|At 6 months||||kg||95% Confidence Interval|Mean
2543892|NCT02968992|Secondary|Tolerability of Oral rhLactoferrin as Assessed by Patient Diary of Total Number of Side Effects|Study coordinators administered side effect questionnaire at each visit and via phone every two weeks during the treatment period.|From baseline through 6 months.||||Side effects/100 treatment days||Standard Deviation|Mean
2543893|NCT02968992|Secondary|Physical Mobility as Measured by 6 Minute Walk Test|A measured course is set up in an open area on a hard flat surface. The test taker walks on this measured course for 6 minutes, and the test administrators calculates the distance traveled over 6 minutes. The test taker is allowed to rest as is needed.|At 6 months||||meter||95% Confidence Interval|Mean
2543894|NCT02968992|Secondary|Physical Mobility as Measured by 4 Meter Walk Test|A standard measurement of 4 meters is marked on a flat, long floor surface. The test taker is asked to walk the length at their usual pace while the test giver is recording the time with a stop watch. This test is repeated twice, and the average of the two recorded times is used as the data point.|At 6 months||||m/sec||95% Confidence Interval|Mean
2543895|NCT02968992|Secondary|Attenuating Cognitive Decline as Measured by the Trail Making Test A and B.|For test A, the test taker is given a sheet of paper that has the numbers 1-25 within individual circles randomly distributed on the page. The test taker is asked to connect the numbers sequentially over a period of 4 minutes (240 seconds). The score is recorded as the time it takes to complete the task in seconds. For test B, the test taker is given a piece of paper that has numbers 1-13 and letters A-L. Each letter or number is inside of a circle. The test taker must then draw a line from one circled number to the next circled letter (ie. 1 to A to 2 to B to 3 to C etc.) over a period of 6 minutes (360 seconds). The time it takes to complete this task is recorded in seconds.|At 6 months|A total of 36 participants entered the study. One participant in the placebo group later dropped out and therefore was not included in the analysis. One additional participant in the placebo group was unable to complete Trail Making Test B, so they were not included in the analysis.|||seconds||95% Confidence Interval|Mean
2543896|NCT02968992|Secondary|Attenuating Cognitive Decline as Measured by the Digital Symbol Substitution Test|The test taker is given a key consisting of numbers 1-9 that are paired with a unique symbol. The test taker is allowed 90 seconds to assign the correct symbol to the number on the list. The test administrator then scores the number of correct answers over the 90 second test time, and assigns a total score based on one point for each correct answer and therefore a higher score is a better outcome.|At 6 months||||correct responses||95% Confidence Interval|Mean
2543897|NCT02968992|Primary|The Effect of Rhlactoferrin on Serum Levels of Tumor Necrosis Factor Alpha Receptor 1 (TNFR1)|The effect of rhlactoferrin on serum levels (picogram/milliliter) of tumor necrosis factor alpha receptor 1 (TNFR1) assessed as a measure of the percentage change of serum TNFR1 levels from baseline|From baseline to 6 months||||Percent change from baseline||Standard Deviation|Mean
2543898|NCT02968992|Primary|The Effect of Rhlactoferrin on Serum Levels of Interleukin-6 (IL-6)|The effect of rhlactoferrin on serum levels (picogram/milliliter) of Interleukin-6 (IL-6) will be assessed as a measure of the percentage change of IL-6 serum levels from baseline|Baseline and 6 months||||Percent change of IL-6||Standard Deviation|Mean
2543899|NCT02968979|Secondary|Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Malnutrition|"Proportion of patients with severe malnutrition according to the subjective assessment of the clinician~Proportion of patients with severe malnutrition according to the malnutrition criteria defined by the HAS."|Day 1|NSCLC patients Severe malnutrition according to Investigator: 15 missing data Severe malnutrition according to the HAS: 416 missing data|||Participants|||Count of Participants
2547897|NCT02896595|Secondary|Total Anesthesia Time|Total anesthesia time as measured in minutes and recorded in the anesthesia record, from anesthesia start time to anesthesia stop time|Up to 270 minutes||||minutes||Standard Error|Mean
2543900|NCT02968979|Secondary|Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Anorexia|"Proportion of patients with anorexia according to the subjective assessment of the clinician~Proportion of patients with anorexia according to the Ingesta VAS~Proportion of patients with anorexia according to the AC/S-FAACT module score~Proportion of patients with anorexia according to question 13 of the QLQ-C30 questionnaire: Have you had a lack of appetite?"|Day 1|NSCLC patients Anorexia according to Investigator: 3 missing data Anorexia according to VAS: 22 missing data Anorexia according to FAACT: 19 missing data Anorexia according to question 13 of QLQ-C30 questionnaire: 33 missing data|||Participants|||Count of Participants
2543901|NCT02968979|Secondary|Comparison of the Proportion of Patients With Cachexia, Anorexia and Malnutrition According to the Subjective Assessment of the Clinician and the Different Objective Assessment Criteria: Cachexia|"Proportion of patients with cachexia according to the subjective assessment of the clinician~Proportion of patients with cachexia according to the Fearon criteria"|Day 1|NSCLC patients Cachexia according to Investigator: 4 missing data Cachexia according to Fearon criteria: 84 missing data|||Participants|||Count of Participants
2543902|NCT02968979|Secondary|Number of Participants With Diabetes Treatments|Diabetes treatments : Yes/No|Day 1|NSCLC patients 6 missing data|||Participants|||Count of Participants
2543903|NCT02968979|Secondary|Number of Participants Receiving Systemic Corticosteroids, Anti-inflammatory Drugs, Omega 3 Fatty Acids Treatments|Treatments with systemic corticosteroids, anti-inflammatory drugs, Omega 3 fatty acids: Yes/No|Day 1|NSCLC patients 11 missing data|||Participants|||Count of Participants
2543904|NCT02968979|Secondary|Number of Participants Receiving a Non-Pharmacological Treatment for Cachexia or for Associated Symptoms|Non-pharmacological treatment of cachexia or associated symptoms: Y/N|Day 1|"NLSCS patients with a nutritional consultation within 2 months before inclusion~1 missing data"|||Participants|||Count of Participants
2543905|NCT02968979|Secondary|Number of Participants Receiving a Pharmacological Treatment for Cachexia or for Associated Symptoms|Pharmacological treatment of cachexia or associated symptoms: Yes / No|Day 1|NSCLC patients 225 missing data|||Participants|||Count of Participants
2543906|NCT02968979|Secondary|Description of the Level of Physical Activity Associated With the Different Stages of Cachexia.|"Three levels of physical activity are defined:~- Low~No activity is reported OR~An activity is reported but does not reach moderate or high levels.~- Moderate~Corresponds to one of the following 3 criteria:~3 or more days of intense activity lasting at least 20 min per day OR~5 or more days of moderate intensity activity and / or walking for at least 30 min per day OR~5 or more days of activity combining walking, activities of moderate or high intensity, thus achieving at least 600 MET-minutes / week~- High~Corresponds to one of the following 2 criteria:~Intense activity at least 3 days a week and at least 1500 MET-minutes / week OR~7 or more days of activity combining walking, moderate and high intensity activities, achieving at least 3000 MET-minutes / week"|Day 1|NSCLC patients 69 missing data|||Participants|||Count of Participants
2543907|NCT02968979|Secondary|Description of the Quality of Life Associated With the Different Stages of Cachexia.|Quality of life has been analysed using scores from the functional scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 items (EORTC QLQ-C30 questionnaire): score ranging from 0 (malfunction) to 100 (healthy level of functioning) for the following parameters : physical, role, cognitive, emotional and social scales|Day 1|NSCLC patients Physical scale: 16 missing data Role scale: 17 missing data Cognitive scale: 16 missing data Emotional scale: 16 missing data Social scale: 18 missing data|||Scale score||Standard Deviation|Mean
2543908|NCT02968979|Secondary|Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Fibrinogen|fibrinogen level|Day 1|NSCLC patients 387 missing data|||g/L||Inter-Quartile Range|Median
2543909|NCT02968979|Secondary|Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - CRP|CRP level|Day 1|NSCLC patients 317 missing data|||mg/L||Inter-Quartile Range|Median
2543910|NCT02968979|Secondary|Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Inflammation Markers - Neutrophil/Lymphocyte Ratio|neutrophil/lymphocyte ratio|Day 1|NSCLC patients 112 missing data|||no unit (ratio)||Inter-Quartile Range|Median
2543911|NCT02968979|Secondary|Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - AC/S FAACT|Score of the 12-question AC/S module (Anorexia-Cachexia module) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) questionnaire assessing anorexia and cachexia: the AC/S module of the FAACT questionnaire consists of 12 questions to assess over the last 7 days quality of life, related to anorexia or cachexia. The score ranges between 0 and 48, the higher the score, the higher the quality of life.|Day 1|NSCLC patients 9 missing data|||score on a scale||Standard Deviation|Mean
2543912|NCT02968979|Secondary|Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Loss of Appetite - Dietary Intake Visual Analog Scale|"Dietary Intake Visual Analog Scale (Dietary intake VAS): The question Could you indicate the amount you currently eat, placing a vertical mark on the line between nothing at all and as usual? . Depending on the location of the patient mark on the scale, a score of between 0 (nothing at all) and 10 (as usual) will be allocated."|Day 1|NSCLC patients 12 missing data|||score on a scale||Standard Deviation|Mean
2543913|NCT02968979|Secondary|Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Blood Glucose|Blood glucose abnormalities according to the different stages of cachexia at inclusion|Day 1|NSCLC patients 329 data missing|||Participants|||Count of Participants
2543914|NCT02968979|Secondary|Description of the Clinical Signs/Symptoms Associated With the Different Stages of Cachexia: Nutritional State|• Nutritional state according to the different stages of cachexia The variables used will be: serum albumin levels, serum pre-albumin levels, BMI and weight.|Day 1|NSCLC patients|||Participants|||Count of Participants
2543915|NCT02968979|Secondary|Frequency of the Different Stages of Cachexia According to the Types of Treatments Received.|Stage of cachexia at inclusion according to the type of treatments received (surgery, radiotherapy, chemotherapy, targeted therapies).|Day 1|NSCLC patients. 101 missing data|||Participants|||Count of Participants
2543916|NCT02968979|Secondary|Frequency of the Different Stages of Cachexia According to the Number of Treatments Received.|NSCLC patients. 84 patients with missing data|Day 1||||Participants|||Count of Participants
2543922|NCT02968979|Secondary|Frequency of the Different Stages of Cachexia in the General NSCLC Population|"Percentage of the different stages of cachexia at inclusion.~The different stages of cachexia used the following classification:~No Cachexia: 1) no weight loss (WL<2%) or 2) weight gain AND no anorexia AND no sarcopenia~The pre-cachexia stage : 1) 2% ≤ weight loss ≤ 5% AND BMI ≥ 20 and/or 2) anorexia (according to question 13 of the quality of life questionnaire QLQ-C30) and/or 3) weight loss < 2% AND sarcopenia~Cachexia: 1) Weight loss > 5% OR 2) weight loss between 2 and 5% AND BMI < 20 kg/m² OR 3) weight loss > 2% AND sarcopenia. In all cases, patient should not have entered the refractory cachexia stage~Refractory cachexia: ECOG 3 or 4 AND low survival expectancy [BMI < 20kg/m² and weight loss ≥ 6%] OR [20 ≤ BMI ≤ 21,9 kg/m² and weight loss ≥ 11%] OR [22 kg/m² ≤ BMI and weight loss ≥ 15%]"|Day 1|Missing data for 84 patients|||Participants|||Count of Participants
2543923|NCT02968979|Primary|Frequency of Cachexia According to Modified Fearon Criteria|"Percentage of NSCLC patients with a cachexia according to Fearon criteria modified for the stages of pre-cachexia and refractory cachexia in order to classify all the featured cases without ambiguity.~A patient was considered to have cachexia if he/she had:~Weight loss >5% in the last 6 months prior to inclusion or~BMI <20 kg/m² and weight loss between 2 and 5% in the 6 months prior to inclusion or~Weight loss >2% and sarcopenia (as evaluated by the muscle mass index at L3) if available. If data were not available regarding possible sarcopenia, the presence of cachexia was assigned based on the 2 above conditions.~In the 3 cases defined above, patient should not have entered the refractory cachexia stage, which was defined as: ECOG performance score of 3 or 4 and a low survival expectancy as defined by Martin et al. (J Clin Oncol 2015) (BMI <20 kg/m² and weight loss ≥ 6%) or (20 ≤ BMI ≤ 21.9 kg/m² and weight loss ≥ 11%) or (22 kg/m² ≤ BMI and weight loss ≥ 15%)."|Day1|missing data for 84 patients|||Participants|||Count of Participants
2543924|NCT02968914|Secondary|Antidrug Antibody (ADA) Status|To evaluate the immunogenicity of Benralizumab|At predose (Day 1), Days 29 and 57|Safety set consisted of all subjects who received at least 1 dose of Benralizumab were included in the safety analysis for the study.|||Participants|||Count of Participants
2543925|NCT02968914|Secondary|Number of Participants With Adverse Events|To evaluate safety and tolerability of Benralizumab|At predose and 2 h postdose (Day 1), Days 2, 4, 5, 6, 8, 15, 29, 43 and 57|Safety set consisted of all subjects who received at least 1 dose of Benralizumab were included in the safety analysis for the study.|||Participants|||Count of Participants
2543926|NCT02968914|Secondary|Apparent Volume of Distribution Based on the Terminal Phase (Vz/F)|To evaluate the Vz/F of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.|At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57|The PK analysis set consisted of all the subjects as defined for above endpoint. For Benralizumab 30mg AI, two subjects and for Benralizumab 30mg AFPS, three subjects were excluded from the PK analysis set.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2543927|NCT02968914|Secondary|Apparent Extravascular Clearance (CL/F)|To evaluate the CL/F of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.|At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57|The PK analysis set consisted of all the subjects as defined for above endpoint. For Benralizumab 30mg AI, two subjects and for Benralizumab 30mg AFPS, three subjects were excluded from the PK analysis set.|||mL/day||Geometric Coefficient of Variation|Geometric Mean
2543928|NCT02968914|Secondary|Terminal Half-life (t½)|To evaluate the t½ of Benralizumab administered to various anatomical injection sites and in subjects with different body weight ranges.|At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57|The PK analysis set consisted of all the subjects as defined for above endpoint. For Benralizumab 30mg AI, two subjects and for Benralizumab 30mg AFPS, three subjects were excluded from the PK analysis set.|||Days||Geometric Coefficient of Variation|Geometric Mean
2543929|NCT02968914|Secondary|Time When Maximum Concentration is Observed (Tmax)|To evaluate the Tmax of Benralizumab administered to various injection sites and in subjects with different body weight ranges|At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57|The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.|||Days||Full Range|Median
2543930|NCT02968914|Primary|Maximum Observed Concentration (Cmax)|To compare the Cmax following single SC administration of Benralizumab by using APFS or AI devices|At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57|The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2543931|NCT02968914|Primary|Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)|To compare the AUClast following single SC administration of Benralizumab by using APFS or AI devices|At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57|The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.|||day·ng/mL||Geometric Coefficient of Variation|Geometric Mean
2543932|NCT02968914|Primary|Area Under the Concentration-time Curve From Zero to Infinity (AUCinf)|To compare the AUCinf following single SC administration of Benralizumab by using APFS or AI devices|At Pre-dose (Day 1) and at Days 2, 4, 5, 6, 8, 15, 29, 43 and 57|The PK analysis set consisted of all subjects who received benralizumab for whom PK blood samples were assumed not to be affected by factors such as protocol violations (e.g., disallowed medications or incomplete dose administration) and who had at least one post dose quantifiable serum PK observation.|||day·ng/mL||Geometric Coefficient of Variation|Geometric Mean
2543933|NCT02968758|Secondary|Indeterminate Sample Results|To estimate the rate of indeterminate results for the GenePOC CDiff Test due to an Instrument failure (indeterminate sample results).|At the time of the results with Reference Method is confirmed, up to 3 months||||percentage of Indeterminates||95% Confidence Interval|Number
2544340|NCT02962687|Other Pre-specified|Number of Participants With Hospitalizations or Emergency Department Visits|Descriptive analysis of emergency department visits and hospitalizations in the two study arms|14 weeks|Utilization data was collected for Veteran participants only.|||participants|||Number
2543935|NCT02968758|Secondary|Positive and Negative Predictive Values (PPV and NPV)|"To estimate the Positive and Negative Predictive Values (PPV and NPV) of the GenePOC CDiff System.~PPV is the percentage of true positives out of all positive results (true positive/true positive + false positive).~NPV is the percentage of true negatives out of all negative results (true negative/true negative +false negative.)."|At the time of the results with Reference Method is confirmed, up to 3 months||||percentage of specimens||95% Confidence Interval|Number
2543936|NCT02968758|Primary|Performance Characteristics : Clinical Sensitivity (True Positive Rate) and Clinical Specificity (True Negative Rate) in Comparison to the Reference Method|"To establish the performance characteristics of the GenePOC CDiff System for its use in determining the presence of CDiff in liquid/unformed stool specimen obtained from patients suspected of having C. difficile infection (CDI).~Sensitivity will be established as the proportion of positives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method.~Specificity will be established as the proportion of negatives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method."|At the time of the results with Reference Method is confirmed, up to 3 months||||percentage of specimens||95% Confidence Interval|Number
2543937|NCT02968576|Primary|Area Under the Concentration-time Curve (AUC)|Tenofovir and emtricitabine area under the concentration-time curve (AUC) following FTC/TDF in the overencapsulated versus non-encapsulated form. Drug concentrations will be assayed with validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methodology.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose|All subjects who completed the study: single dose of unencapsulated and coencapsulated TDF/FTC. A 14-day washout separated each dosing.|||ng*h/mL|PK timepoint samples|Geometric Coefficient of Variation|Geometric Mean
2543938|NCT02968576|Primary|Peak Plasma Concentration (Cmax)|Tenofovir and emtricitabine concentration max (Cmax) following FTC/TDF in the overencapsulated versus non-encapsulated form. Drug concentrations will be assayed with validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methodology.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose|All subjects who completed the study: single dose of unencapsulated and coencapsulated TDF/FTC. A 14-day washout separated each dosing.|||ng/mL|PK timepoint samples|Geometric Coefficient of Variation|Geometric Mean
2543939|NCT02968277|Secondary|Forearm and Hand Grip|Specialty gloves and load cells will be used to measure to amount of load participants are using when using each device on the hands and also on the forearm. This will be collected during the six-minute walk test.|One testing session||||kilograms||Standard Error|Mean
2543940|NCT02968277|Secondary|Borg Rate of Perceived Exertion|The Borg Rate of Perceived Exertion is a scale that measures perceived exertion during activity. The minimum score is 6 and the maximum score is 20, with higher values on the scale indicative of higher perceived exertion while completing an activity.|One testing session||||score on a scale||Standard Error|Mean
2543941|NCT02968277|Secondary|User Functional Rating Scale|"Is specifically to assess the user's perception of difficulty in performing the functional tasks when using the different assistive devices. The scale is similar to the patient specific functional scale wherein functional tasks are rated in level of their difficulty from 0 (inability to perform the task) to 10 (no difficulty in performing the task.)."|One testing session||||score on a scale||Standard Deviation|Mean
2543942|NCT02968277|Secondary|Visual Analog Pain Scale (VAS)|"The Visual Analog Scale Pain Scale is a measure of perceived pain intensity. It consists of a horizontal line that is 10 centimeters long. On either side of the line is a description of pain- to the left the description will read No pain, and to the right the description will read worst pain imaginable. The individual is instructed to mark a point on the continuum which represents his/her pain."|Baseline score taken at first session||||score on a scale||Standard Deviation|Mean
2543943|NCT02968277|Secondary|Baseline Modified Falls Efficacy Scale (mFES) Score:|"The mFES is self-report questionnaire consisting of 14 items which is designed to measure fear of falling in the elderly. It assesses an individual's perception of balance during activities of daily living by asking how confident are you that you can do the following activities without falling. Subjects answer questions about how confident they are in safely completing various tasks on a scale from 0 to 10, with 10 indicating greater confidence. The score below is the average item-score for the assessment."|Baseline score taken at first session||||score on a scale||Standard Deviation|Mean
2543944|NCT02968277|Secondary|10 Meter Walk Test|Time to walk 10 meters is measured to calculate gait speed.|One testing session||||meters per second||Standard Error|Mean
2543945|NCT02968277|Primary|6 Minute Walk Test|The 6 minute walk test is performed as an objective evaluation of functional exercise capacity. The 6minute walk test is easy to administer, well tolerated, and typically reflective of activities of daily living. The test measures the distance that the patient can walk on a flat, hard surface, indoors, in a period of 6 minutes. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. The number of stops and stumbles will be recorded during the test. This test will be administered while wearing a mask to measure oxygen consumption in addition to blood pressure, heart rate and oxygen saturation.|One testing session||||meters||Standard Error|Mean
2543946|NCT02968173|Secondary|Total Days of Mechanical Ventilation During RSV-hospitalization||Approximately 6 months|All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.||||||
2543947|NCT02968173|Secondary|Percentage of Participants Who Received Mechanical Ventilation||Approximately 6 months|All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.||||||
2543948|NCT02968173|Secondary|Total Days of RSV-ICU Stay||Approximately 6 months|All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.||||||
2543949|NCT02968173|Secondary|Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization||Approximately 6 months|All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.||||||
2543950|NCT02968173|Secondary|Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement|Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.|Approximately 6 months|All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.||||||
2543951|NCT02968173|Secondary|Percentage of Participants Who Received Supplemental Oxygen While Hospitalized|Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms.|Approximately 6 months|All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.||||||
2543952|NCT02968173|Secondary|Total Number of RSV-Hospitalization Days||Approximately 6 months|All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.||||||
2543953|NCT02968173|Primary|Percentage of Participants With RSV Hospitalization|An RSV hospitalization is defined as either 1) a respiratory/cardiac hospitalization with a positive RSV test, 2) new onset of respiratory/cardiac symptoms in an already hospitalized child, with an objective measure of worsening respiratory/cardiac status and a positive RSV test, or 3) deaths, which can be demonstrated as caused by RSV (by autopsy or clinical history and virologic evidence).|Approximately 6 months||||percentage of participants||95% Confidence Interval|Number
2543954|NCT02968134|Primary|Posaconazole Exposure Expressed as Area Under the Unbound Concentrations-time Curve From Time Zero to Infinity|This is a measure of free posaconazole ( not bound to plasma proteins) exposure in the plasma. This is an important measure of exposure because its the free concentration that distributes into targets sites of infection to produce clinical effect.|48 hours||||ng*h/mL||Inter-Quartile Range|Median
2543955|NCT02968134|Primary|Posaconazole Exposure Described as Area Under the Total Plasma Concentration-time Curve From Time Zero to Infinity After a Single Dose|The primary outcome is plasma posaconazole exposure expressed as the area under the total plasma concentration-time curve from time zero to infinity resulting from a single dose of 300 mg of posaconazole administered intravenously.|48 hours||||ng*h/mL||Inter-Quartile Range|Median
2543956|NCT02967991|Secondary|Length of the Longest Piece Under Histologic Examination|"length of the longest tissue biopsy piece (centimeters) as measured by pathology Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB.~FNA-fine needle aspiration FNB-fine needle biopsy"|7 days|specimens not participants|||mean cm for portal tracts of specimens|specimens|Standard Deviation|Mean
2543957|NCT02967991|Secondary|Aggregate Specimen Length Under Histologic Examination|"Length of all the tissue (centimeters) by adding the sum of all pieces Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB.~FNA-fine needle aspiration FNB-fine needle biopsy"|7 days|specimens not participants|||cm for portal tracts of specimens|specimens|Standard Deviation|Mean
2543958|NCT02967991|Secondary|Number of Portal Tracts (PT) in the Specimen (Total) Under Histologic Examination|"Number of portal tracts (PT) in the specimen (total) under histologic examination Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB.~FNA-fine needle aspiration FNB-fine needle biopsy"|7 days|specimens not participants|||mean portal tracts|specimens|Standard Deviation|Mean
2543959|NCT02967991|Secondary|The Number of Patients Requiring Medical Care After Needle Biopsy|"Patient requiring visit to healthcare center (emergency room, hospital, call to service) within time 7 days Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB.~FNA-fine needle aspiration FNB-fine needle biopsy"|7 Days||||Participants|||Count of Participants
2543960|NCT02967991|Secondary|The Number of Patients With Pain 7 Day After Needle Biopsy|"Pain using Likert score 0-10 (10 worst) Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB.~FNA-fine needle aspiration FNB-fine needle biopsy"|7 days||||Participants|||Count of Participants
2543961|NCT02967991|Secondary|The Number of Patients With Pain 1 Day After Needle Biopsy|"Pain using Likert score 0-10 (10 worst) Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB.~FNA-fine needle aspiration FNB-fine needle biopsy"|1 days||||Participants|||Count of Participants
2543962|NCT02967991|Secondary|The Number of Patients With Visible Bleeding After Needle Biopsy|"Patient with blood visible from patient's mouth, rectum with a 2 gram drop in hemoglobin Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB.~FNA-fine needle aspiration FNB-fine needle biopsy"|7 days||||Participants|||Count of Participants
2543963|NCT02967991|Secondary|The Number of Specimens With a Visible Clot After Needle Biopsy|"Presence of visible clots in specimen (yes/no) Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB.~FNA-fine needle aspiration FNB-fine needle biopsy"|Day of Procedure|specimens not participants|||specimens|specimens||Number
2543964|NCT02967991|Secondary|The Number of Specimens With a Visible Core After Needle Biopsy|"Presence of a visible core specimen (yes/no) Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB.~FNA-fine needle aspiration FNB-fine needle biopsy"|Day of Procedure|specimens not particpants|||specimens|specimens||Number
2543965|NCT02967991|Primary|Number of Specimens for Which a Histologic Diagnosis Could be Made Based Upon the Amount of Tissue Obtained With the Needle|"Defined by total portal structures > 5 or length of the longest piece > 15 mm) Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB.~FNA-fine needle aspiration FNB-fine needle biopsy"|7 days|specimens not particpants|||specimens|specimens||Number
2546803|NCT02915978|Secondary|Time (Minutes) to First Use of Rescue Medication (Duration of Analgesia) Following Each Dose of the Investigational Product (IP)||Within 48 hours|All randomized participants from the Intent-to-Treat (ITT) population.|||minutes||95% Confidence Interval|Mean
2543966|NCT02967510|Secondary|Change From Baseline to Week 3 in the Proportion of Parabasal Cells of the Vaginal Epithelium|Change from Baseline to Week 3 in the proportion of parabasal cells of the vaginal epithelium was reported. A decrease in proportion of parabasal cells compared to baseline represents a positive outcome.|Baseline to Week 3|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||ratio||Standard Error|Least Squares Mean
2543967|NCT02967510|Secondary|Change From Baseline to Week 3 in the Proportion of Superficial Cells of the Vaginal Epithelium|Change from baseline to week 3 in the proportion of superficial cells of the vaginal epithelium was reported.|Baseline to Week 3|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||ratio||Standard Error|Least Squares Mean
2543968|NCT02967510|Secondary|Change From Baseline to Week 3 in Vaginal pH|Change from Baseline to Week 3 in vaginal pH was reported. A decrease in pH compared to Baseline represents a positive outcome.|Baseline to Week 3|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||pH||Standard Error|Least Squares Mean
2543969|NCT02967510|Secondary|Change From Baseline to Week 3 in the Severity of Dry Mucosa|Percentage of subjects with change from Baseline to Week 3 in severity of dry mucosa was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.|Baseline to Week 3|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||Participants|||Count of Participants
2543970|NCT02967510|Secondary|Change From Baseline to Week 3 in the Severity of Presence of Petechiae|Percentage of subjects with change from Baseline to Week 3 in the severity of presence of petechiae was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.|Baseline to Week 3|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||Participants|||Count of Participants
2543971|NCT02967510|Secondary|Change From Baseline to Week 3 in the Severity of Thinning or Flattening of Folds|Percentage of subjects with change from Baseline to Week 3 in severity of thinning or flattening of folds was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.|Baseline to Week 3|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||Participants|||Count of Participants
2543972|NCT02967510|Secondary|Change From Baseline to Week 3 in the Severity of Friability|Percentage of subjects with change from Baseline to Week 3 in severity of friability was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.|Baseline to Week 3|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||Participants|||Count of Participants
2543973|NCT02967510|Secondary|Change From Baseline to Week 3 in the Severity of Pallor|Percentage of subjects with change from Baseline to Week 3 in severity of pallor was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.|Baseline to Week 3|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||Participants|||Count of Participants
2543974|NCT02967510|Secondary|Change From Baseline to Week 3 in the Global Symptom Score 2|Change from Baseline to Week 3 in the Global Symptom Score 2 was reported. Global Symptom Score 2 was defined as the sum of all 4 individual symptoms excluding dyspareunia (vaginal dryness, pruritus or itching, burning, and dysuria) for each subject at each time point: Screening/Baseline, Week 3 and Week 12/ET., and was calculated only when all 4 symptom scores had a response available. The maximum score possible to be obtained at a visit with the Global Symptom Score 2 was 12 (all symptoms severe in intensity). A decrease in score compared to baseline represented a positive outcome.|Baseline to Week 3|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||units on a scale||Standard Error|Least Squares Mean
2543975|NCT02967510|Secondary|Change From Baseline to Week 3 in the Global Symptom Score 1|Global Symptom Score 1 was defined as the sum of all 5 individual symptom scores at a given visit, and was calculated only when all 5 symptom scores had a response available. the Global Symptom Score 1 ranged at Screening/Baseline between 2 (at least moderate vaginal dryness -per inclusion criteria) to 15 (all 5 studied symptoms severe in intensity). At Week 3 visit, the Global Symptom Score ranged between 0 (no symptoms) and 15 (all symptoms severe in intensity). A decrease in score compared to Baseline represented a positive outcome.|Baseline to Week 3|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||units on a scale||Standard Error|Least Squares Mean
2543976|NCT02967510|Secondary|Change From Baseline to Week 3 in the Severity of Dysuria|Percentage of subjects with change from Baseline to Week 3 in severity of dysuria was reported. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.|Baseline to Week 3|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||Participants|||Count of Participants
2543977|NCT02967510|Secondary|Change From Baseline to Week 3 in the Severity of Burning|Percentage of subjects with change from Baseline to Week 3 in severity of burning was reported. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.|Baseline to Week 3|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||Participants|||Count of Participants
2543978|NCT02967510|Secondary|Change From Baseline to Week 3 in the Severity of Pruritus or Itching|Percentage of subjects with change from Baseline to Week 3 in the severity of pruritus or itching was reported. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.|Baseline to Week 3|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||Participants|||Count of Participants
2543979|NCT02967510|Secondary|Change From Baseline to Week 3 in the Severity of Dyspareunia|Percentage of subjects with change from Baseline to Week 3 in severity of dyspareunia was reported. Dyspareunia was only applicable in subjects who had experienced sexual activity with penetration since the previous study visit. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.|From baseline to week 3|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint|||Participants|||Count of Participants
2543980|NCT02967510|Secondary|Change From Baseline to Week 3 in the Severity of Vaginal Dryness|Percentage of subjects with change from Baseline to Week 3 in the severity of vaginal dryness was reported. Severity was defined as: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.|Baseline to Week 3|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||Participants|||Count of Participants
2543981|NCT02967510|Secondary|Change From Baseline to Week 12 in the Severity of Dry Mucosa|Percentage of subjects with change from Baseline to Week 12 in the severity of dry mucosa was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.|Baseline to Week 12|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||Participants|||Count of Participants
2543982|NCT02967510|Secondary|Change From Baseline to Week 12 in the Severity of Petechiae|Percentage of subjects with change from Baseline to Week 12 in the severity of presence of petechiae was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.|Baseline to Week 12|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||Participants|||Count of Participants
2543983|NCT02967510|Secondary|Change From Baseline to Week 12 in the Severity of Thinning or Flattening of Folds|Percentage of subjects with change from Baseline to Week 12 in the severity of thinning or flattening of folds was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.|Baseline to Week 12|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||Participants|||Count of Participants
2543984|NCT02967510|Secondary|Change From Baseline to Week 12 in the Severity of Friability|Percentage of subjects with change from Baseline to Week 12 in the severity of friability was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive outcome.|Baseline to Week 12|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||Participants|||Count of Participants
2543985|NCT02967510|Secondary|Change From Baseline to Week 12 in the Severity of Pallor.|Percentage of subjects with change from Baseline to Week 12 in the severity of pallor was reported. Sign scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive putcome.|Baseline to Week 12|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||Participants|||Count of Participants
2543986|NCT02967510|Secondary|Change From Baseline to Week 12 in the Global Symptom Score 2|Change from Baseline to Week 12 in the Global Symptom Score 2 was reported. Global Symptom Score 2 was defined as the sum of all 4 individual symptoms excluding dyspareunia (vaginal dryness, pruritus or itching, burning, and dysuria) for each subject at each time point: Screening/Baseline, Week 3 and Week 12/ET., and was calculated only when all 4 symptom scores had a response available. The maximum score possible to be obtained at a visit with the Global Symptom Score 2 was 12 (all symptoms severe in intensity). A decrease in score compared to baseline represented a positive outcome.|Baseline to Week 12|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||units on a scale||Standard Error|Least Squares Mean
2543987|NCT02967510|Secondary|Change From Baseline to Week 12 in the Global Symptom Score 1|Global Symptom Score 1 was defined as the sum of all 5 individual symptom scores at a given visit, and was calculated only when all 5 symptom scores had a response available. the Global Symptom Score 1 ranged at Screening/Baseline between 2 (at least moderate vaginal dryness -per inclusion criteria) to 15 (all 5 studied symptoms severe in intensity). At Week 12/ET visit, the Global Symptom Score ranged between 0 (no symptoms) and 15 (all symptoms severe in intensity). A decrease in score compared to Baseline represented a positive outcome.|Baseline to Week 12|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||units on a scale||Standard Error|Least Squares Mean
2543988|NCT02967510|Secondary|Change From Baseline to Week 12 in the Severity of Dysuria|Percentage of subjects with change from Baseline to Week 12 in the severity of dysuria was reported. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to baseline represented a positive putcome.|Baseline to Week 12|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||Participants|||Count of Participants
2543989|NCT02967510|Secondary|Change From Baseline to Week 12 in the Severity of Burning|Percentage of subjects with change from Baseline to Week 12 in the severity of burning was reported. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to Baseline represented a positive outcome.|Baseline to Week 12|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||Participants|||Count of Participants
2543990|NCT02967510|Secondary|Change From Baseline to Week 12 in the Severity of Pruritus or Itching|Percentage of subjects with cvhange from Baseline to Week 12 in the severity of pruritus or itching was reported. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to Baseline represented a positive outcome.|Baseline to Week 12|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||Participants|||Count of Participants
2547898|NCT02896595|Secondary|Fluoroscopy Time|As measured and reported by electrophysiology and radiology notes, recorded in minutes|Up to 270 minutes||||minutes||Standard Error|Mean
2543991|NCT02967510|Secondary|Change From Baseline to Week 12 in the Severity of Dyspareunia|Percentage of subjects with change from baseline to week 12 in the severity of dyspareunia was reported. Dyspareunia was only applicable in subjects who had experienced sexual activity with penetration since the previous study visit. Symptom scores at each visit: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to Baseline represented a positive outcome.|Baseline to Week 12|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||Participants|||Count of Participants
2543992|NCT02967510|Primary|Change From Baseline to Week 12 in the Proportion of Parabasal Cells of the Vaginal Epithelium.|Change from Baseline to Week 12 in the proportion of parabasal cells of the vaginal epithelium was reported. A decrease in proportion of parabasal cells compared to Baseline represents a positive outcome.|Baseline to Week 12|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||ratio||Standard Error|Least Squares Mean
2543993|NCT02967510|Primary|Change From Baseline to Week 12 in the Proportion of Superficial Cells of the Vaginal Epithelium.|Change from Baseline to week 12 in the proportion of superficial cells of the vaginal epithelium was reported.|Baseline to Week 12|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||ratio||Standard Error|Least Squares Mean
2543994|NCT02967510|Primary|Change From Baseline to Week 12 in Vaginal pH|Change from Baseline to Week 12 in Vaginal pH was reported. A decrease in pH compare to Baseline represents a positive outcome.|Baseline to Week 12|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||pH||Standard Error|Least Squares Mean
2543995|NCT02967510|Primary|Change From Baseline to Week 12 in the Severity of Vaginal Dryness|Percentage of Subjects with change from baseline to week 12 in the severity of vaginal dryness was reported. Severity was defined as: 0= Absent, 1= Mild, 2= Moderate, 3= Severe. A decrease in score compared to Baseline represented a positive outcome.|From baseline to week 12|The ITT population defined as all randomized subjects. The number of subjects analyzed defined as number of subjects evaluable for this endpoint.|||Participants|||Count of Participants
2543996|NCT02967458|Primary|Percentage of Subjects With Previously Unidentified Prostate Cancer Using Magnetic Resonance Imaging|Study subjects will be scanned with subharmonic imaging during infusion of the microbubble contrast agent. Imaging results will be compared to pathology on prostate biopsy.|One week from baseline|Thirty one subjects of the total 55 had prior negative MRI or negative MRI guided biopsy|||Participants|||Count of Participants
2543997|NCT02967458|Primary|Percentage of Biopsy Cores in Which Prostate Cancer Was Detected Using Subharmonic Imaging|Study subjects will be scanned with subharmonic imaging during infusion of the microbubble contrast agent. Imaging results will be compared to pathology on prostate biopsy.|One week from baseline||||percentage of biopsy cores|||Number
2543998|NCT02967458|Primary|Percentage of Subjects Whose Prostate Cancer Was Detected With Subharmonic Imaging|The initial phase of the trial will develop and test subharmonic imaging to demonstrate enhanced visualization of prostate vascularity in all study participants. We will report the percentage of study subjects in whom visualization of prostate vascularity is increased with subharmonic imaging.|One week from baseline||||Participants|||Count of Participants
2543999|NCT02967393|Secondary|Number Participants With Asthma Exacerbations Requiring Medical Attention|For the purpose of this study, asthma exacerbation will be defined as: any acute episode of progressively worsening shortness of breath/dyspnea, cough, wheezing, chest tightness, and/or respiratory distress during the 42 days post-vaccination (until day 43) for which the patient seeks unscheduled medical attention (e.g., healthcare provider office or Emergency Department visit or hospitalization)|42 days||||Participants|||Count of Participants
2544000|NCT02967393|Secondary|Number of Asthma Exacerbations Requiring Steroids|For the purpose of this study, asthma exacerbation will be defined as: any acute episode of progressively worsening shortness of breath/dyspnea, cough, wheezing, chest tightness, and/or respiratory distress during the 42 days post-vaccination (until day 43) for which the patient receives a new prescription for systemic corticosteroids..|42 days||||number of events|||Number
2544001|NCT02967393|Secondary|Unsolicited and Severe Adverse Events|The nature and frequency of the unsolicited and Severe adverse events will be described in children receiving ccIIV4 and IIV4 during the 42 days after vaccination.|42 days||||number of events|||Number
2544002|NCT02967393|Secondary|Severe Systemic Reactogenicity Events During the 14 Days Post-vaccination|Number of solicited severe (not serious) systemic reactogenicity events for 14 days after vaccination between recipients of ccIIV4 and IIV4.|14 days||||number of events|||Number
2544003|NCT02967393|Secondary|Severe Local Reactogenicity Events During the 14 Days Post-vaccination|Number of severe local reactogenicity events for 14 days after vaccination between recipients of ccIIV4 and IIV4.|14 days||||number of events|||Number
2544004|NCT02967393|Primary|Feasibility Benchmark: Number of Parents Completing a Satisfaction Survey|Parent of each participant will be asked to complete a at the end of the study|42 days|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
2544005|NCT02967393|Primary|Feasibility Benchmark: Number of Parents That Respond to Day 44 Call|Number of parents that respond to Day 44 ( Plus 3 Days) call and provide requested data.|Day 44-47|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
2544006|NCT02967393|Primary|Feasibility Benchmark: Number of Parents That Respond to Day 29 Call and Provide Requested Data.|Number of Parents that respond to Day 29 ( Plus 2 Days) call and provide requested data.|Day 29-31|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
2544007|NCT02967393|Primary|Feasibility Benchmark: Number of Parents That Respond to Day 15 Call and Provide Requested Data|Number of parents that respond to Day 15 (minus 1 or plus 2 days) call and provide requested data|Day 14 to 17|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
2544008|NCT02967393|Primary|Feasibility Benchmark: Number of Parents That Respond to Day 8 Call and Provide Requested Data.|Number of parents that respond to Day 8 (plus 2 days) call and provide requested data.|Day 8-10|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
2544009|NCT02967393|Primary|Feasibility Benchmark: Number of Parents That Respond to Day 4 Call and Provide Requested Data|Number of parents that respond to Day 4 ( -1 day or + 2 days) call and provide requested data|Day 3 to 6|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
2544010|NCT02967393|Primary|Feasibility Benchmark: Number of Parents That Document Nighttime Awakenings|Number of parents that document nighttime awakenings for at least 11 of the 15-day monitoring period.|15 days|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
2544011|NCT02967393|Primary|Feasibility Benchmark: Number of Parents That Perform and Document the Digital Peak Flow for Day 42|Parent will perform and document the digital peak flow for Day 42|Day 42|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received.. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
2544012|NCT02967393|Primary|Feasibility Benchmark: Number of Parents That Perform and Document All Home Digital Peak Flow Measurements|Number of parents that perform and document all home digital peak flow measurements at least 11 days out of the 15-day monitoring period.|15 days|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
2544013|NCT02967393|Primary|Feasibility Benchmark: Number of Parent Completing Collection of Adverse Event Data|Parent will collect the following data: need for new prescription or nonprescription medications for the control of asthma, an unscheduled healthcare provider visit or consultation within 42 days after vaccination, any other clinically significant event occurring at any point during the study period. Serious Adverse Events (SAEs) will also be monitored through 42 days after vaccination and will include events that result in death, were life threatening, result in subject hospitalization or prolongation of existing hospitalization, result in persistent or significant disability or incapacity. Additionally, important medical events that may not have resulted in death, were not life threatening, or did not require hospitalization might be considered SAEs when, according to appropriate medical judgment, they jeopardize the patient or subject and require medical or surgical intervention to prevent one of the outcomes listed above.|Day 16 to 43|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
2544014|NCT02967393|Primary|Feasibility Benchmark: Number of Parents That Complete the Memory Aid 1.|Memory aid 1 is a diary completed by the subjects Parent. Daily symptoms, peak flow and requires the parent to record daily symptoms, peak flow, days, post-vaccination asthma clinical symptoms and symptom scores, adverse event, fever and concomitant medication administration data for 14 days (until day 15) after vaccination.|15 days|Feasibility Measures are done by the parent/guardian of the participants and results are not dependent on the type of vaccine received. Feasibility Measure data will be reported as a single group.|||Participants|||Count of Participants
2544015|NCT02967367|Secondary|Light Sleep|a percentage corresponding to sleep time spent in light sleep (stage N1 and N2 on polysomnography) divided by total sleep time|one night (up to 600 minutes)||||a percentage of total sleep time||Standard Deviation|Mean
2544016|NCT02967367|Secondary|Deep Sleep|a percentage corresponding to sleep time spent in deep sleep (stage N3 on polysomnography) divided by total sleep time|one night (up to 600 minutes)||||a percentage of total sleep time||Standard Deviation|Mean
2544017|NCT02967367|Primary|Total Sleep Time|time spent sleeping during the night (minutes)|one night (up to 600 minutes)||||min||Standard Deviation|Mean
2544018|NCT02967367|Primary|Sleep Efficiency|a percentage corresponding to total sleep time divided by time in bed|one night (up to 600 minutes)||||percentage of time in bed||Standard Deviation|Mean
2544019|NCT02967367|Primary|Time in Bed|time spent in bed during the night (minutes)|one night (up to 600 minutes)||||min||Standard Deviation|Mean
2544020|NCT02967354|Secondary|Hepatic Fat Content||Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release|Some of the study participants were not included in the analysis because of not being able to participate in the MRI scan or insufficient image quality.|||% of liver volume||Standard Deviation|Mean
2544021|NCT02967354|Secondary|Pancreatic Fat Content||Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release|Some of the study participants were not included in the analysis because of not being able to participate in the MRI scan, pancreatic anatomical abnormality or insufficient image quality.|||% of pancreatic volume||Standard Deviation|Mean
2544022|NCT02967354|Secondary|Pancreatic Volume||Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release|Some participants were not included in the analysis because of not being able to participate in the imaging, pancreatic anatomical abnormality or insufficient image quality.|||cm^3||Standard Deviation|Mean
2544023|NCT02967354|Secondary|Pancreatic Perfusion|Uptake of radioactive water with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release|Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release|Some individuals in the study population were not included in the analysis because of not being able to participate in the PET scan, pancreatic anatomical abnormality or insufficient image quality.|||ml/min||Standard Deviation|Mean
2544072|NCT02965820|Primary|Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30|CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.|Day 30, each product|Full Analysis Set with non-missing responses|||units on a scale||Standard Deviation|Mean
2544024|NCT02967354|Primary|[11C]5-hydroxy-tryptophan Uptake in the Pancreas|Uptake of tracer with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release|Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release|"Two healthy controls and two individuals in the group Normal weight, treated with oral antidiabetic drugs + insulin were not included in the analysis because of not being able to participate in the PET scan, pancreatic anatomical abnormality or insufficient image quality."|||% of injected dose||Standard Deviation|Mean
2544025|NCT02966795|Secondary|Percentage of Participants With Relapse|Relapse was defined as confirmed HCV RNA ≥ 15 IU/mL between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment as planned with HCV RNA < 15 IU/mL at the end of treatment and had post-treatment HCV RNA data; participants who had been shown to be re-infected were not considered to have relapsed.|End of treatment (week 8 or 12 depending on the treatment regimen) through 12 weeks after the end of treatment.|All enrolled participants who received at least one dose of study drug, with HCV RNA < 15 IU/mL at the end of treatment, at least one post-treatment HCV RNA value, and who completed the assigned treatment.|||percentage of participants||95% Confidence Interval|Number
2544026|NCT02966795|Secondary|Percentage of Participants With On-treatment HCV Virologic Failure|"HCV virologic failure was defined as one of the following conditions:~confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < 15 IU/mL during the Treatment Period; or confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) at any time point during the Treatment Period; or~HCV RNA ≥ 15 IU/mL at end of treatment with at least 6 weeks of treatment, where the HCV RNA value must be collected on or after Study Drug Day 36 and study drug duration ≥ 36 days."|8 or 12 weeks (depending on the treatment regimen)|All enrolled participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2544027|NCT02966795|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post Treatment (SVR12)|SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last actual dose of study drug.|12 weeks after last dose of study drug (week 20 or 24 depending on the treatment regimen)|All enrolled participants who received at least one dose of study drug. Backward imputation, where applicable, was used to impute missing data. Participants with missing data after backward imputation were counted as non-responders.|||percentage of participants||95% Confidence Interval|Number
2544028|NCT02966509|Secondary|Patient Satisfaction With Decision-Making Using the Satisfaction With Decision Survey|Each patient will receive a validated satisfaction with decision-making survey (The Satisfaction with Decision Survey) at 6 months after study enrollment.Satisfaction with Decision was assessed with the use of the 6-question Satisfaction with Decision Scale, on which scores range from 0 to 5, with higher scores indicating better satisfaction with decision-making. Scores for each group are averaged at 6 months after study enrollment.|6 months||||units on a scale||Standard Deviation|Mean
2544029|NCT02966509|Secondary|Change in Patient Satisfaction With Care Using the Consumer Assessment of Health Care Providers and Systems -General Survey|Each patient will receive a satisfaction with care survey (The Consumer Assessment of Health Care Providers and Systems - General (CAHPS)) at baseline and 6 months. We will measure the change in satisfaction from baseline to 6 months. Scores for satisfaction were assessed using the Consumer Assessment of Healthcare Providers and Systems-General survey question #18 which measured rating of health provider, on which scores range from 0 to 10, with higher ratings correspond to higher patient satisfaction. Scores for each group are averaged at baseline and at 6 months.|Change in Patient Satisfaction with Care from baseline to 6 months.||||units on a scale||Standard Deviation|Mean
2544030|NCT02966509|Secondary|Palliative Care Referral (Chart Review)|Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.|15 months after patient enrollment||||Participants|||Count of Participants
2544031|NCT02966509|Secondary|Palliative Care Referral (Chart Review)|Palliative Care Referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.|6 months after patient enrollment||||Participants|||Count of Participants
2544032|NCT02966509|Secondary|Hospice Referral (Chart Review)|Hospice referral for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.|6 months after patient enrollment||||Participants|||Count of Participants
2544033|NCT02966509|Secondary|Hospitalization Visits (Chart Review)|Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.|15 months after patient enrollment||||Visits||Standard Deviation|Mean
2544034|NCT02966509|Secondary|Hospitalization Visits (Chart Review)|Hospitalization use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.|6 months after patient enrollment||||Visits||Standard Deviation|Mean
2544035|NCT02966509|Secondary|Emergency Department Visit (Chart Review)|Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 15 months after enrollment.|15 months after patient enrollment||||Visits||Standard Deviation|Mean
2544036|NCT02966509|Secondary|Emergency Department Visit (Chart Review)|Emergency Department Use for each patient will be abstracted by electronic medical record chart review for each patient at 6 months after enrollment.|6 months after patient enrollment||||visits||Standard Deviation|Mean
2544037|NCT02966509|Primary|Number of Participants With Completed Goals of Care Documentation. We Will Evaluate if 75% of Patients in the Intervention Arm Have a Documented Goals of Care Titled Medical Note Within 6 Months of Patient Enrollment in the Study.|Feasibility is defined as at least 75% of patients in the intervention arm with a documented Goals of Care titled medical note within 6 months of patient enrollment in the study.|6 months after each patient enrollment||||Participants|||Count of Participants
2544073|NCT02965729|Secondary|Physical Activity Change|Physical activity was measured in the pedometer only and pedometer plus goals groups using an Omron pedometer (Omron HJ-324U, Omron Healthcare, Lake Forest, IL). Change was calculated as difference between baseline and end of 10-week study.|10 weeks|"Pedometers were not worn in the No Pedometer cohorts and so data were not collected."|||steps||Standard Deviation|Mean
2544038|NCT02966353|Secondary|Percentage of Participants Transfusion Independency From Baseline up to Week 96|"Percentage is based on number of subjects who are transfusion dependent at baseline. Transfusion dependence (TD) is defined as subjects receiving 6 or more units of transfusions 12 weeks prior to baseline. Transfusion independence (TI) rate is defined as subjects who are transfusion dependent at baseline and require no unit of transfusion for ≥ 12 weeks at any time during the study.~Transfusion response rate is defined as subjects who are TD at baseline and have 5 or less units of transfusion for ≥ 12 weeks at any time during the study."|Baseline up to week 96|Number of participants that were transfusion dependent at baseline|||percentage of participants|||Number
2544039|NCT02966353|Secondary|Patient Global Impression of Change (PGIC) at Week 24 and Week 48|The PGIC is comprised of a single question intended to measure a subject's perspective of improvement or deterioration over time relative to treatment. The PGIC uses a seven-point scale where '1' equals very much improved and '7' equals very much worse.|Baseline up to week 48|Participants with PGIC response at that time point|||Participants|||Count of Participants
2544040|NCT02966353|Secondary|Percentage of Participants With at Least a 50% Reduction in Myelofibrosis 7 Item Symptom Scale (MF-7) and Myelofibrosis Symptom Assessment Form (MFSAF) at Week 24|The MF-7 is a disease specific questionnaire comprised of 7 items that measures the severity of seven of the most prevalent associated symptoms including: tiredness, early satiety, abdominal discomfort, night sweats, itching (pruritus), bone pain (diffuse not joint or arthritis) and pain under ribs on left side. Each item was scored on a scale ranging from 0 (absent) to 10 (worst imaginable). The MF-7 score is computed as the sum of the observed scores in the individual items to achieve a 0 to 70 score. There would be one recall period of 24 hours used in this questionnaire. A separate question on Inactivity was to be measured for severity of this symptom on a scale from 0 (absent) to 10 (worst imaginable). This would allow the computation of the MFSAF v2.0 questionnaire results, as 6 out of 7 items in the latter PRO are in overlap with MF7 (they also share same 0-10 range Likert scale and ascending order, absent to worst imaginable).|Baseline and week 24||||percentage of participants||95% Confidence Interval|Number
2544041|NCT02966353|Secondary|Percentage of Participants by Spleen Length Reduction or no Increase From Baseline Category at Week 24 and Week 48|Participants who achieved a ≤ 50% reduction in spleen length at week 24 and 48 (reduction) and participants who had no increase greater than or equal to 50% (increase). The edge of the spleen shall be determined by palpation, measured in centimeters, using a soft ruler, from the costal margin to the point of greatest splenic protrusion. For subjects with palpable spleen at baseline and non-palpable at post-baseline, the post-baseline spleen is imputed as 0.|baseline, weeks 24 and 48|Full analysis set n: participants with a value at both Baseline and that time point.|||percentage of participants|||Number
2544042|NCT02966353|Secondary|Percentage of Participants With at Least 50% Reduction in Spleen Length From Baseline at Week 48|Percentage of participants achieving a 50% reduction in spleen length at week 48. For subjects with palpable spleen at baseline and non-palpable at post-baseline, the post-baseline spleen is imputed as 0. Subjects who had palpable, but missing spleen length at baseline is excluded from the analysis. Subjects with missing spleen length at Week 48 or who withdraw earlier from the study are considered as a non-responder. The 95% CI is computed using exact Clopper-Pearson method.|Baseline up to week 48|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2544043|NCT02966353|Primary|Percentage of Participants With at Least 50% Reduction in Spleen Length From Baseline at Week 24|Percentage of participants achieving a 50% reduction in spleen length at week 24. For subjects with palpable spleen at baseline and non-palpable at post-baseline, the post-baseline spleen are imputed as 0. Subjects who had palpable, but missing spleen length at baseline is excluded from the analysis. Subjects with missing spleen length at Week 24 or who withdraw earlier from the study are considered as a non-responder. The 95% CI is computed using exact Clopper-Pearson method.|Baseline up to week 24||||percentage of participants||95% Confidence Interval|Number
2544044|NCT02966340|Secondary|Self-reported Anxiety Potentiation During Stress Reactivity Task.|After the No-shock, Predictable-shock, Unpredictable-shock (NPU) task participants retrospectively reported their anxiety/fear during each condition on a 5-point likert scale (1 = 'Not at all anxious/ fearful', 5 = 'Very anxious/fearful'). The startle response is a defensive reflex that is elicited by an auditory stimuli (e.g., 50ms white noise) and measured via eyeblink electromyogram (EMG) activity over the obicularis oculi muscle. Startle potentiation is calculated as the increase in startle during unpredictable and predictable stressors relative to a no-stressor condition in the NPU task. Outcome is anxiety potentiation during unpredictable shock and predictable shock (vs. no-shock) conditions. This was assessed with a single question, total possible range was 1-5.|7 days||||units on a scale||95% Confidence Interval|Mean
2544045|NCT02966340|Primary|Startle Potentiation During Stress Reactivity Task.|The unpredictable shock and predictable shock startle response potentiation (vs. no shock) during the administration of the NPU stressor task. Values represent point estimate of effect from unadjusted general linear model analyses with 95% confidence intervals|7 days||||startle potentiation (μV)||95% Confidence Interval|Mean
2544046|NCT02966275|Secondary|Severity of Nausea on Daily E-mail Survey|The visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. We used a simple VAS is a straight horizontal line of fixed length measuring 0-100mm with subscale markings every 10mm. The ends are defined as the extreme limits of the parameter to be measured (nausea) orientated from the left (least severity or 0) to the right (most severity or 100mm). Subjects can mark their response anywhere from 0 to 100mm. The mean severity of nausea for the group in each arm was calculated by averaging all responses in either arm.|14 days||||millimeters||Standard Deviation|Mean
2544047|NCT02966275|Secondary|Number of Days With Nausea|Number of days with nausea calculated from daily survey|14 days||||days||Standard Deviation|Mean
2544048|NCT02966275|Secondary|Percentage of Days When Participants Correctly Guessed Intervention (Glucagon vs Placebo) Out of a Total of 14 Days.||2 weeks||||percentage of days||Standard Deviation|Mean
2544049|NCT02966275|Secondary|Number of Symptomatic Hypoglycemia Events Per Day|Number of symptomatic hypoglycemia events per day calculated from daily email survey|14 days||||events per day||Standard Deviation|Mean
2544050|NCT02966275|Secondary|Total Glucagon Dosing (mcg/kg/24 Hours)||2 weeks||||mcg/kg/day||Standard Deviation|Mean
2544051|NCT02966275|Secondary|Total Number of Grams of Carbohydrate Taken for Hypoglycemia Per Day|Calculated from daily email survey|14 days||||grams||Standard Deviation|Mean
2544053|NCT02966275|Secondary|Mean Absolute Relative Deviation (MARD) of CGM vs. All StatStrip Xpress BG Measurements|MARD is computed using the difference between the CGM readings and the values measured at the same time by the reference measurement system. The mean (or average) of all the absolute relative deviations produces the MARD. In this study, the reference measurement system was the StatStrip Xpress meter, to which the CGM values were compared.|14 days|The 2 arms are combined for this analysis as subjects switched arms either daily or every other day through the 14 days. During this period, subjects wore 2 sensors in total (1 sensor lasts 7 days). We do not expect a difference in accuracy resulting from switching arms this frequently or relating to glucagon vs placebo.|||percent difference||Standard Deviation|Mean
2544054|NCT02966275|Secondary|Fraction of Time Spent Within the Glucose Range >250 mg/dl||2 weeks||||percentage of time||Standard Deviation|Mean
2544055|NCT02966275|Secondary|Percentage of Time Spent Within the Glucose Range >180 mg/dl||14 days||||percentage of time||Standard Deviation|Mean
2544056|NCT02966275|Secondary|Percentage of Time Spent Within the Glucose Range 70-180 mg/dl||14 days||||percentage of time||Standard Deviation|Mean
2544057|NCT02966275|Secondary|Percentage of Time Spent Within the Glucose Range 70-120 mg/dl||14 days||||percentage of time||Standard Deviation|Mean
2544058|NCT02966275|Secondary|Percentage of Time With CGM Glucose Less Than 60 mg/dl During Daytime ( 7:00 AM-11:00 PM)||14 days||||percentage of time||Standard Deviation|Mean
2544059|NCT02966275|Secondary|Percentage of Time With CGM Glucose Less Than 60 mg/dl Overnight (11:00 PM - 7:00 AM)||14 days||||percentage of time||Standard Deviation|Mean
2544060|NCT02966275|Secondary|Mean Continuous Glucose Monitor (CGM) Glucose||2 weeks||||mg/dl||Standard Deviation|Mean
2544061|NCT02966275|Primary|Area Over the Curve and <60 mg/dl (CGM) Measured in mg/dl *Min|The measure for area over the curve is used when an integrated assessment (e.g., a measurement of something over a specific amount of time) is more useful in understanding a phenomenon. To calculate this measure, a method of approximation is often used. One way would be to estimate the curve via curve-fitting techniques. For this outcome, using area over the curve and <60mg/dl provides a more robust method of calculating amount of hypoglycemia (by including more severe degrees of hypoglycemia in the product of mg/dl*min as opposed to percentage of time below 60mg/dl.|14 days||||mg/dl *minute||Standard Deviation|Mean
2544062|NCT02966015|Primary|Number of Participants Successfully Able to Insert Catheter|"The subjects had to evaluate if it was possible to insert and navigate the Coloplast Test catheter through urethra by the 5-point Likert question: How did you find the catheter navigates through the urethra during insertion ( Very easily, Easily, Neither/nor, Difficultly, Very difficultly, Not possible). The catheterization was considered successful if it was possible to insert the catheter, meaning that ifthey selected any other answer than 'not possible'."|1 week||||Participants|||Count of Participants
2544063|NCT02966002|Secondary|Quality of Life|The Medical Outcomes Short-Form 36-Item Health Survey (SF-36) is a standardized health survey consisting of 36 questions that measure 8 dimensions of general health-related quality of life: physical functioning, role limitation due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and general mental health. The score is represented as an average of the individual question scores, and ranges from 0 (not functioning) to 100 (highest functioning). Higher scores indicate a better health status.|8 weeks||||units on a scale||Standard Deviation|Mean
2544064|NCT02966002|Secondary|High Sensitivity CRP(C-Reactive Protein)|Change will be measured from baseline to retest after 8 weeks of treatment|8 weeks||||mg/dL||Standard Deviation|Mean
2544065|NCT02966002|Primary|Change in HDL (High-Density Lipoprotein)-Cholesterol|Change will be measured from baseline to retest after 8 weeks of treatment|8 weeks||||mg/dL||Standard Deviation|Mean
2544066|NCT02966002|Primary|Change in Total Cholesterol|Change will be measured from baseline to retest after 8 weeks of treatment|8 weeks||||mg/dL||Standard Deviation|Mean
2544067|NCT02965924|Secondary|Change in Intraocular Pressure (IOP)|Intraocular pressure will be measured in mmHg after topical anesthesia by using the pneumatonometer. There will be a minimum of three IOP measurements and a mean will be accepted as IOP.|baseline, 60 minutes||||mmHg||Standard Deviation|Mean
2544068|NCT02965924|Primary|Change in Episcleral Venous Pressure (EVP)|EVP will be measured non-invasively using a custom-modified slit-lamp mounted venomanometer. This device utilizes the pressure chamber technique, in which a clear flexible balloon is placed against the conjunctival surface of the eye, and the pressure is increased until an episcleral vein is noted to blanch. The system for pressure-chamber based venomanometry includes a computer-controlled motor drive to increase pressure automatically, a transducer to record pressure, and a high-definition video camera to record vein collapse. Pressure measurements are synchronized with the video stream and image analysis software is used to determine the pressure required to collapse the vein to a specific pre-determined degree as measured in mmHg.|baseline, 60 minutes||||mmHg||Standard Deviation|Mean
2544069|NCT02965846|Secondary|Change From Baseline in Tearfilm Break Up Time (TBUT)|For TBUT, the mean of 3 measurements of time in seconds will be computed at each visit for each eye. The mean value of the study eye will be used for the analysis.|Baseline (day 1) to 6 month visit|Efficacy analyses including the change from baseline in Tearfilm Break Up Time (TBUT) were planned. Ultimately, these analyses were not performed due to the fact that the study was terminated before the primary/secondary efficacy visit could be reached.||||||
2544070|NCT02965846|Primary|Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe)|The overall ocular discomfort will be assessed on a questionnaire using a 0 to 4 scale on which 0=none, 1=mild, 2=moderate, 3=severe and 4=very severe.|6 month visit|Efficacy analyses including the overall ocular discomfort score were planned. Ultimately, these analyses were not performed due to the fact that the study was terminated before the primary/secondary efficacy visit could be reached.||||||
2544071|NCT02965833|Primary|Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30|CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.|Day 30, each product|Full Analysis Set with non-missing responses|||units on a scale||Standard Deviation|Mean
2546804|NCT02915978|Secondary|Number of Participants Using Rescue Medication||Within 48 hours|All randomized participants from the Intent-to-Treat (ITT) population.|||Participants|||Count of Participants
2544074|NCT02965729|Secondary|Subjective Health Change|"Subjective health was measured using a 1-item Likert scale (In general, how would you say your health is?). Change was calculated as difference between baseline and end of 10-week study. The scale ranged from 0 to 4, with higher values indicating a better outcome."|10 weeks|Data were not collected for the ‘‘No Pedometer’’ cohorts.|||units on a scale||Standard Deviation|Mean
2544075|NCT02965729|Secondary|Physical Activity Enjoyment Change|Physical activity enjoyment was measured using the Physical Activity Enjoyment Scale (PACES). Change was calculated as difference between baseline and end of 10-week study. The scale ranged from 0 to 32, with higher values indicating a better outcome.|10 weeks|Data were not collected for the ‘‘No Pedometer’’ cohorts.|||units on a scale||Standard Deviation|Mean
2544076|NCT02965729|Secondary|Quality of Life Kidscreen-10 Index Change|Health-related quality of life was measured using the Kidscreen-10 Index. Change was calculated as difference between baseline and end of 10-week study. the scale ranged from 0 to 15, with higher values indicating a better outcome.|10 weeks|Data were not collected for the ‘‘No Pedometer’’ cohorts.|||units on a scale||Standard Deviation|Mean
2544077|NCT02965729|Secondary|Body Weight Change|Weight was measured using a calibrated scale. Change was calculated as difference between baseline and end of 10-week study.|10 weeks||||kg||Standard Deviation|Mean
2544078|NCT02965729|Secondary|BMI Change|BMI was calculated as weight in kg divided by height in meters squared. Change was calculated as difference between baseline and end of 10-week study.|10 weeks||||kg/m2||Standard Deviation|Mean
2544079|NCT02965729|Primary|BMI Z-score Change|Height was measured at sessions 1 and 10 using a stadiometer. Weight was measured at each session using a calibrated scale. BMI z-score was calculated from the Centers for Disease Control and Prevention macro program based on the sex, height, and age of the child. Change was calculated as difference between baseline and end of 10-week study.|10 weeks||||z score||Standard Deviation|Mean
2544080|NCT02965599|Secondary|Changes From Baseline in Myeloid-related Protein 8/14 (MRP8/14)|Blood samples were collected at the indicated time points and analyzed by flow cytometry for cell markers to determine any changes after treatment with GSK3117391. Change from Baseline was defined as the post-Baseline value minus the value at Baseline. Baseline was defined as the value from the Day 1 (pre-dose). Individual participant data has been presented. Only data available at specified visit with respect to the participant has been presented.|Baseline (pre-dose, Day 1); 1, 4, 10 Hours on Day 1; Day 2 (24 Hours); Pre-dose, 8 Hours on Day 3; Pre-dose on Day 7; Day 14; Pre-dose on Day 21; Pre-dose on Day 27; Day 28 (24 Hours) and Day 44 (Follow-up)|Safety Population. Only those participants with data available at specified time point has been analyzed (represented by n=x in category titles). Data has been presented for participants as per the actual treatment received.|||Milligram per liter|||Number
2544081|NCT02965599|Secondary|Changes From Baseline in Soluble Cytokine|Change from Baseline, was defined as the post-Baseline value minus the value at Baseline. Baseline was defined as the value from the Day 1 (pre-dose). Blood samples were planned to be analyzed by flow cytometry for cell markers to determine any changes after treatment with GSK3117391. This analysis was planned but the assay was not performed due to sample size being too small at the time of early study termination.|Baseline (pre-dose, Day 1) and up to 44 Days|Safety Population. Data was not collected, assay was not performed due to sample size being too small at the time of early study termination.||||||
2544082|NCT02965599|Secondary|Change From Baseline in Monocyte Count|Blood samples were collected at the indicated time points for the analysis of monocytes. Change from Baseline was defined as the post-Baseline value minus the value at Baseline. Baseline was defined as the value from the Day 1 (pre-dose). Individual participant data has been presented. Only data available at specified visit with respect to the participant has been presented.|Baseline (pre-dose, Day 1); 1, 4, 6, 10 Hours on Day 1; Day 2 (24 Hours); Pre-dose, 1, 4, 8 Hours on Day 3; Pre-dose on Day 7; Day 14; Pre-dose on Day 21; Pre-dose, 1, 4, 6, 10 Hours on Day 27; Day 28 (24 Hours); Day 30 (72 Hours) and Day 44 (Follow-up)|Safety Population. Only those participants with data available at specified time point has been analyzed (represented by n=x in category titles). Data has been presented for participants as per the actual treatment received.|||Giga cells per liter|||Number
2544083|NCT02965599|Secondary|Apparent Volume of Distribution (V/F) of GSK3117391 and GSK3339189|V/F, is defined as the theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that it is observed in the blood plasma. Blood samples, were planned to be collected for GSK3117391, at the specified timepoints. This analysis was planned but was not performed as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 1) and 24 hours (Day 2) post-dose; pre-dose, 0.25, 0.5, 1, 4, and 8 hours (Day 3) post-dose; pre-dose (Day 7); pre-dose (Day 21); pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 27) and 24 hours post-dose|PK Population. Data was not collected, as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.||||||
2544084|NCT02965599|Secondary|Apparent Total Clearance (CL/F) of GSK3117391 and GSK3339189|CL/F, describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). Blood samples, were planned to be collected for GSK3117391, and its acid metabolite GSK3339189, at the specified timepoints. This analysis was planned but was not performed as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 1) and 24 hours (Day 2) post-dose; pre-dose, 0.25, 0.5, 1, 4, and 8 hours (Day 3) post-dose; pre-dose (Day 7); pre-dose (Day 21); pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 27) and 24 hours post-dose|PK Population. Data was not collected, as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.||||||
2544094|NCT02965599|Secondary|Change From Baseline in CRP|Blood samples were collected at indicated time points for the analysis of CRP. Change from Baseline, was defined as the post-baseline value minus the value at Baseline. Baseline was defined as the value from the Day 1 (pre-dose). Individual participant data has been presented. Only data available at specified visit with respect to the participant has been presented.|Baseline (pre-dose, Day 1) and Days 7, 14, 21, 28, Follow-up (Day 44)|Safety Population. Only those participants with data available at specified time point has been analyzed (represented by n=x in category titles). Data has been presented for participants as per the actual treatment received.|||Milligrams per liter|||Number
2544085|NCT02965599|Secondary|Observed Accumulation Ratio (Ro) of GSK3117391 and GSK3339189|Blood samples were planned to be collected for GSK3117391, and its acid metabolite GSK3339189, at the specified timepoints. Accumulation ratio was planned to be determined from the ratio of AUC from time zero to time of next dosing (AUC [0-tau]) following single dose administration /AUC (0-tau) on repeat dose administration. This analysis was planned but was not performed as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 1) and 24 hours (Day 2) post-dose; pre-dose, 0.25, 0.5, 1, 4, and 8 hours (Day 3) post-dose; pre-dose (Day 7); pre-dose (Day 21); pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 27) and 24 hours post-dose|PK Population. Data was not collected, as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.||||||
2544086|NCT02965599|Secondary|Trough Concentration (Ctau) of GSK3117391 and GSK3339189|Blood samples were planned to be collected for GSK3117391 and its acid metabolite GSK3339189, at the specified timepoints. This analysis was planned but was not performed as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 1) and 24 hours (Day 2) post-dose; pre-dose, 0.25, 0.5, 1, 4, and 8 hours (Day 3) post-dose; pre-dose (Day 7); pre-dose (Day 21); pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 27) and 24 hours post-dose|PK Population. Data was not collected, as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.||||||
2544087|NCT02965599|Secondary|Apparent Terminal Phase Half-life (t1/2) of GSK3117391 and GSK3339189|Blood samples were planned to be collected for GSK3117391 and its acid metabolite GSK3339189, at the specified timepoints. This analysis was planned but was not performed as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 1) and 24 hours (Day 2) post-dose; pre-dose, 0.25, 0.5, 1, 4, and 8 hours (Day 3) post-dose; pre-dose (Day 7); pre-dose (Day 21); pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 27) and 24 hours post-dose|PK Population. Data was not collected, as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.||||||
2544088|NCT02965599|Secondary|AUC From Time Zero to Infinity (AUC[0-infinity]) of GSK3117391 and GSK3339189|Blood samples were planned to be collected for GSK3117391 and its acid metabolite GSK3339189, at the specified timepoints. This analysis was planned but was not performed as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 1) and 24 hours (Day 2) post-dose; pre-dose, 0.25, 0.5, 1, 4, and 8 hours (Day 3) post-dose; pre-dose (Day 7); pre-dose (Day 21); pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 27) and 24 hours post-dose|PK Population. Data was not collected, as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.||||||
2544089|NCT02965599|Secondary|AUC From Time Zero to the Time of Next Dosing (AUC[0- Tau]) of GSK3117391 and GSK3339189|Blood samples were planned to be collected for GSK3117391 and its acid metabolite GSK3339189, at the specified timepoints. This analysis was planned but was not performed as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 1) and 24 hours (Day 2) post-dose; pre-dose, 0.25, 0.5, 1, 4, and 8 hours (Day 3) post-dose; pre-dose (Day 7); pre-dose (Day 21); pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 27) and 24 hours post-dose|PK Population. Data was not collected, as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.||||||
2544090|NCT02965599|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC[0-t]) of GSK3117391 and GSK3339189|Blood samples were planned to be collected for GSK3117391, and its acid metabolite GSK3339189, at the specified time points. This analysis was planned but was not performed as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 1) and 24 hours (Day 2) post-dose; pre-dose, 0.25, 0.5, 1, 4, and 8 hours (Day 3) post-dose; pre-dose (Day 7); pre-dose (Day 21); pre-dose, 0.25 hour, 0.5, 1, 2, 4, 6, 10 hours (Day 27) and 24 hours post-dose|PK Population. Data was not collected, as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.||||||
2544091|NCT02965599|Secondary|Time to Cmax (Tmax)of GSK3117391 and GSK3339189|Tmax was defined as time required to achieve Cmax for drug, in the plasma. Blood samples were planned to be collected for GSK3117391 and its acid metabolite GSK3339189, at the specified timepoints. This analysis was planned but was not performed as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 1) and 24 hours (Day 2) post-dose; pre-dose, 0.25, 0.5, 1, 4, and 8 hours (Day 3) post-dose; pre-dose (Day 7); pre-dose (Day 21); pre-dose, 0.25 hour, 0.5, 1, 2, 4, 6, 10 hours (Day 27) and 24 hours post-dose|PK Population. Data was not collected, as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.||||||
2544092|NCT02965599|Secondary|Maximum Observed Blood Concentration (Cmax) of GSK3117391 and GSK3339189|Cmax was defined as the maximum concentration of drug in the plasma. Blood samples were planned to be collected for GSK3117391 and its acid metabolite GSK3339189, at the specified time points. This analysis was planned but was not performed as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 1) and 24 hours (Day 2) post-dose; pre-dose, 0.25, 0.5, 1, 4, and 8 hours (Day 3) post-dose; pre-dose (Day 7); pre-dose (Day 21); pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 27) and 24 hours post-dose|PK Population. Data was not collected, as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.||||||
2544093|NCT02965599|Secondary|Plasma Concentrations of GSK3117391 and GSK3339189|Blood samples were planned to be collected for GSK3117391 and its acid metabolite GSK3339189, at the specified timepoints. The Pharmacokinetic (PK) Population was defined as participants in the Safety Population who received an active dose and for whom a PK sample was obtained and analyzed. This analysis was planned but was not performed as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.|Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 1) and 24 hours (Day 2) post-dose; pre-dose, 0.25, 0.5, 1, 4, and 8 hours (Day 3) post-dose; pre-dose (Day 7); pre-dose (Day 21); pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 27) and 24 hours post-dose|PK Population. Data was not collected, as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.||||||
2544095|NCT02965599|Secondary|Assessment of Disease Activity Using Patient's Global Assessment of Arthritis (PtGA)|"Participants completed the global assessment of disease activity using the PtGA item using visual analogue scale (VAS) ranging from 0 (none) to 100 (extremely active), respectively. Individual participant score has been presented. Only data available at specified visit with respect to the participant has been presented."|Days 1, 7, 14, 21, 28 and Follow-up (Day 44)|Safety Population. Only those participants with data available at specified time point has been analyzed (represented by n=x in category titles). Data has been presented for participants as per the actual treatment received.|||Scores on a Scale|||Number
2544096|NCT02965599|Secondary|Change From Baseline in DAS28-CRP Over Time|The DAS28 score is a derived measurement with differential weighing given to each component as: TJC28 and SJC28 both scored 0-28 (higher scores indicate higher disease activity), CRP measured in milligrams per liter and PtGA (visual analogue scale with values from 0 [best] to 100 [worst]). The formula used to calculate DAS28 score was 0.56 multiplied by square root of TJC28 plus 0.28 multiplied by square root of SJC28 plus 0.36 log of (CRP plus 1) plus 0.014 multiplied by PtGA plus 0.96. DAS28 scores ranged from 0 (best) to 10 (worst). A negative change from Baseline value indicated improvement. Baseline was defined at Day 1 (pre-dose). Change from Baseline was post-baseline value minus the value at Baseline. Only data available at specified visit with respect to the participant has been presented.|Baseline (pre-dose, Day 1) and Days 7, 14, 21, 28, Follow-up (Day 44)|Safety Population. Only those participants with data available at specified time point has been analyzed (represented by n=x in category titles). Data has been presented for participants as per the actual treatment received.|||Scores on a Scale|||Number
2544097|NCT02965599|Secondary|Number of Tender/Painful Joints Assessed Using 28-joint Counts|The total number of joints ranging from 0 to 28 joints with a present tenderness were assessed. The following 28 joints were taken into account for TJC28: Shoulder (2 joints), Knee (2), Elbow (2), Wrist (2), Fingers (PIP and MCP: 20). No missing observations were considered. Individual participant data has been presented. Only data available at specified visit with respect to the participant has been presented.|Days 1, 7, 14, 21, 28 and Follow-up (Day 44)|Safety Population. Only those participants with data available at specified time point has been analyzed (represented by n=x in category titles). Data has been presented for participants as per the actual treatment received.|||Tender/painful joints|||Number
2544098|NCT02965599|Secondary|Number of Swollen Joints Assessed Using 28-joint Counts|The total number of joints ranging from 0 to 28 joints with a present swelling were assessed. The following 28 joints were taken into account for SJC28: Shoulder (2 joints), Knee (2), Elbow (2), Wrist (2), Fingers (Joints for proximal interphalangeal [PIP] and metacarpophalangeal [MCP]: 20). No missing observations were considered. Individual participant data has been presented. Only data available at specified visit with respect to the participant has been presented.|Days 1, 7, 14, 21, 28 and Follow-up (Day 44)|Safety Population. Only those participants with data available at specified time point has been analyzed (represented by n=x in category titles). Data has been presented for participants as per the actual treatment received.|||Swollen joints|||Number
2544099|NCT02965599|Secondary|Percentage of Participants Achieving ACR 70, Criteria|A participant was considered to be a responder according to the ACR70 criteria if the participant had at least 70% improvement in both the tender joint count and swollen joint count measures, and 70% improvement in at least 3 of the following 5 measures: patient and physician global assessments, pain, disability, and an acute-phase reactant. This analysis was planned but data was not collected , as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.|Up to Day 44|Safety Population. Data was not collected, as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.||||||
2544100|NCT02965599|Secondary|Percentage of Participants Achieving ACR 50, Criteria|A participant was considered to be a responder according to the ACR50 criteria if the participant had at least 50% improvement in both the tender joint count and swollen joint count measures, and 50% improvement in at least 3 of the following 5 measures: patient and physician global assessments, pain, disability, and an acute-phase reactant. This analysis was planned but data was not collected , as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.|Up to Day 44|Safety Population. Data was not collected, as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.||||||
2544101|NCT02965599|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Criteria|A participant was considered to be a responder according to the ACR20 criteria if the participant had at least 20% improvement in both the tender joint count and swollen joint count measures, and 20% improvement in at least 3 of the following 5 measures: patient and physician global assessments, pain, disability, and an acute-phase reactant. This analysis was planned but data was not collected , as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.|Up to Day 44|Safety Population. Data was not collected, as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.||||||
2544102|NCT02965599|Secondary|Number of Participants With Abnormal Findings for Urinalysis Parameters|Urine samples were collected for the analysis of specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones at specified time points. The number of participants with abnormal urinalysis findings have been presented.|Up to Day 44|Safety Population|||Participants|||Count of Participants
2544103|NCT02965599|Secondary|Number of Participants With Values for Hematology Parameters of PCI|Blood samples were collected for analysis of hematology parameters. PCI ranges were for platelets (< 50 or >550 × 10^9 cells/L), white blood cell count (<3 or >14 × 10^9 cells/L), hemoglobin (<90 or >180 g/L), hematocrit (if proportion of red blood cells in blood was <0.3 or >0.54), lymphocytes (<0.5 × 10^9 cells/L), neutrophils (<1.0 × 10^9 cells/L) and monocytes (<0.2 or 1.5 × 10^9 cells/L). The number of participants with values for hematology parameters of PCI have been presented.|Up to Day 44|Safety Population|||Participants|||Count of Participants
2544114|NCT02965534|Primary|Night Myopia|"Value of refractive shift (SE) when changing luminance from a photopic to a mesopic level.~At Baseline, participants were not separated into arms as the Randomization Process was carried out at a later time point after participants picked up study glasses. Therefore, data are presented for All Participants in one Arm/Group."|Baseline only||||D||Standard Deviation|Mean
2547899|NCT02896595|Primary|Procedure Time (Minutes)|Will be measured as time from start of procedure to end of procedure, as recorded in minutes|Up to 270 minutes||||minutes||Standard Deviation|Mean
2544104|NCT02965599|Secondary|Number of Participants With Values for Clinical Chemistry Parameters of PCI|Blood samples were collected for analysis of clinical chemistry parameters. The PCI ranges were for Albumin <30 millimoles/Liter (mmol/L), Calcium (<2 or >2.75 mmol/L), Creatinine (>44.2 mmol/L), Glucose (<3 or >9 mmol/L), Magnesium (<0.5 or >1.23 mmol/L), Phosphorus (<0.8 or > 1.6 mmol/L), Potassium (<3 or > 5.5 mmol/L), Sodium (<130 or 150 mmol/L), Total carbon-dioxide (<18 or > 32 mmol/L), Alanine aminotransferase (>= 2x Upper Limit of Normal [ULN]), Aspartate aminotransferase (>=2x ULN), alkaline phosphatase (>=2x ULN), and total bilirubin (>=1.5xULN). The number of participants with values for clinical chemistry parameters of PCI have been presented|Up to Day 44|Safety Population|||Participants|||Count of Participants
2544105|NCT02965599|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Twelve-lead ECGs were performed during the study using an automated ECG machine, after 5 minutes of rest. The number of participants with abnormal ECG findings were reported and categorized as clinically significant and not clinically significant. Any value for ECG parameters out of the following normal range was considered as clinically significant abnormality; for PR interval <110 or >220 milliseconds, for QRS interval <75 or >110 milliseconds and for QT corrected interval <450 milliseconds.|Up to Day 44|Safety Population|||Participants|||Count of Participants
2544106|NCT02965599|Secondary|Number of Participants With Vital Signs Values of Potential Clinical Importance (PCI)|Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature and heart rate were measured in semi-supine position after 5 minutes rest. The PCI ranges for vitals were as follows; for SBP <85 or >160 millimeters of mercury (mmHg), for DBP <45 or >100 mmHg, for heart rate <40 or >110 beats per minute and for temperature <36 or >38 Celsius. The number of participants with vital signs of PCI have been presented.|Up to Day 44|Safety Population|||Participants|||Count of Participants
2544107|NCT02965599|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect and other situations which involve medical or scientific judgment, and is associated with liver injury and impaired liver function.|Up to Day 44|Safety Population.|||Participants|||Count of Participants
2544108|NCT02965599|Primary|Change From Baseline in Disease Activity Score for 28 Different Joints With (DAS28) C-reactive Protein (CRP) at Day 28|The DAS28 score is a derived measurement with differential weighing given to each component as: Tender/Painful Joint Count (TJC28) and swollen joint count (SJC28) both scored 0-28 (higher scores indicate higher disease activity), CRP measured in milligrams per liter and Patient's Global Assessment of Arthritis (PtGA) (visual analogue scale with values from 0 [best] to 100 [worst]). The formula used to calculate DAS28 score was 0.56 multiplied by square root of TJC28 plus 0.28 multiplied by square root of SJC28 plus 0.36 log of (CRP plus 1) plus 0.014 multiplied by PtGA plus 0.96. DAS28 scores ranged from 0 (best) to 10 (worst). A negative change from Baseline value indicated improvement. Baseline was defined at Day 1 (pre-dose). Change from Baseline was post-baseline value minus the value at Baseline. Safety Population consisted of all participants who received at least one dose of study medication. Individual participant data at Day 28 has been presented.|Baseline (pre-dose, Day 1) and Day 28|Safety Population. Only those participants with data available at specified time point were analyzed.|||Units on a scale|||Number
2544109|NCT02965534|Secondary|Subjective Driving Safety in Dark Light Conditions|"Evaluation of subjective perceived driving safety sense with the study and control glasses.~Both glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used.~Question:~How would you evaluate driving safety sense when driving in twilight or night with the tested glasses? Answer: visual analogue scale slider from 0 (not safe) to 100 (very safe)"|Test Period (4 weeks)||||scores on a scale (0 to 100)||Standard Deviation|Mean
2544110|NCT02965534|Secondary|Subjective Glare Sensitivity in Dark Light Conditions|"Evaluation of subjective perceived glare sensitivity with the study and control glasses.~Both glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used.~Question:~How would you evaluate glare sensitivity with the tested glasses in dark light conditions? Answer: visual analogue scale slider from 0 (no glare) to 100 (strong glare)"|Test Period (4 weeks)||||scores on a scale (0 to 100)||Standard Deviation|Mean
2544111|NCT02965534|Secondary|Subjective Vision Sharpness in Dark Light Conditions|"Evaluation of subjective perceived vision sharpness with the study and control glasses.~Both glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used.~Question:~How would you evaluate vision sharpness with the tested glasses in dark light conditions? Answer: visual analogue scale slider from 0 (insufficient) to 100 (very good)"|Test Period (4 weeks)||||evaluation points (0 to 100)||Standard Deviation|Mean
2544112|NCT02965534|Secondary|Subjective Vision Comfort in Dark Light Conditions|"Evaluation of subjective perceived vision comfort with the study and control glasses.~Both glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used.~Question:~How would you evaluate vision comfort with the tested glasses in dark light conditions? Answer: visual analogue scale slider from 0 (insufficient) to 100 (very good)"|Test Period (4 weeks)||||scores on a scale (0 to 100)||Standard Deviation|Mean
2544113|NCT02965534|Secondary|Mesopic Visual Acuity Improvement|"Difference of visual acuity (monocular and binocular) in a darkened room (0.1 lux) after a dark adaption period of 5 min. with photopic spectacle correction (classic refraction obtained in photopic light conditions) compared to mesopic spectacle correction (correction of night myopia)~Scale: logMAR visual acuity, using Landolt C optotypes.~At Baseline, participants were not separated into arms as the Randomization Process was carried out at a later time point after participants picked up study glasses. Therefore, data are presented for All Participants in one Arm/Group."|Baseline only||||logMAR visual acuity||Full Range|Median
2547164|NCT02911909|Secondary|Tight Circumference|Compare tight circumference of the involved leg between Delfi and the control group|12 months|No patient in the Delfi group complete the 12 months evaluation / No data obtained in the Delfi group|||cm||Standard Deviation|Mean
2544115|NCT02965456|Secondary|Percent Change From Baseline in Inflammatory Lesion Count to Week 12|Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.|Baseline, Week 12|ITT population included all randomized participants who received study drug. Multiple imputation (MCMC) was used to impute missing values.|||percent change||Standard Deviation|Least Squares Mean
2544116|NCT02965456|Secondary|Percent Change From Baseline in Noninflammatory Lesion Count to Week 12|Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.|Baseline, Week 12|ITT population included all randomized participants who received study drug. Multiple imputation (MCMC) was used to impute missing values.|||percent change||Standard Deviation|Least Squares Mean
2544117|NCT02965456|Primary|Percentage of Participants With Treatment Success at Week 12|"Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to Clear or Almost Clear. EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe."|Baseline, Week 12|ITT population included all randomized participants who received study drug and evaluable for EGSS score. Multiple imputation (MCMC) was used to impute missing values.|||percentage of participants|||Number
2544118|NCT02965456|Primary|Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12|Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.|Baseline, Week 12|ITT population included all randomized participants who received study drug. Multiple imputation (MCMC) was used to impute missing values.|||lesion count||Standard Deviation|Least Squares Mean
2544119|NCT02965456|Primary|Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12|Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.|Baseline (Day 0), Week 12|ITT population included all randomized participants who received study drug. Multiple imputation (Markov Chain Monte Carlo [MCMC]) was used to impute missing values.|||lesion count||Standard Deviation|Least Squares Mean
2544120|NCT02964910|Secondary|Number of Participants Who Experienced Unsolicited Adverse Reactions/Events|Number of participants who experienced unsolicited adverse reactions/events during the whole period of observation.|Day 0-Month 7|All the participants who received at least one injection.|||Participants|||Count of Participants
2544121|NCT02964910|Secondary|Number of Participants Who Experienced Solicited System Adverse Reactions/Events|Number of participants who experienced solicited system adverse reactions/events within 7 days after each vaccination.|Day 0-Day 7|All the participants who received at least one injection.|||Participants|||Count of Participants
2544122|NCT02964910|Secondary|Number of Participants Who Experienced Solicited Local Adverse Reactions/Events|Number of participants who experienced solicited local adverse reactions/events within 7 days after each vaccination.|Day 0-Day 7|All the participants who received at least one injection.|||Participants|||Count of Participants
2544123|NCT02964910|Secondary|Number of Participants Who Experienced Solicited Adverse Reactions/Events|Number of participants who experienced local, system adverse reactions/events within 7 days after each vaccination.|Day 0-Day 7|All the participants who received at least one injection.|||Participants|||Count of Participants
2544124|NCT02964910|Secondary|Number of Participants Who Experienced Any Adverse Reactions/Events|Any adverse reactions/events contains solicited and unsolicited adverse reactions/events during the whole period of observation.|Day 0-Month 7|All the participants who received at least one injection.|||Participants|||Count of Participants
2544125|NCT02964910|Secondary|Number of Participants With Changes in Liver Function Index Before The First Dose and One Month After the Third Dose|"ALT, AST and TBIL were detected in both groups to determine the liver function of participants. The grade of ALT, AST and TBIL was determined according to the rules issued by CFDA. The fluctuations were classified into three categories: no change indicated no grade change; processed indicated a change from normal to abnormal or an increase in grade; and improved indicated a change from abnormal to normal or a decrease in grade or the change from abnormal to normal."|Day0-Month 7|All the participants who visited at one month after the third dose.|||Participants|||Count of Participants
2544126|NCT02964910|Secondary|Number of Participants With Changes in Liver Function Index Before and One Month After the Third Dose|"ALT, AST and TBIL were detected in both groups to determine the liver function of participants. The grade of ALT, AST and TBIL was determined according to the rules issued by CFDA. The fluctuations were classified into three categories: no change indicated no grade change; processed indicated a change from normal to abnormal or an increase in grade; and improved indicated a change from abnormal to normal or a decrease in grade or the change from abnormal to normal."|Month 6-Month 7|All the participants who visited at one month after the third dose.|||Participants|||Count of Participants
2544127|NCT02964910|Secondary|Number of Participants With Changes in Liver Function Index Before and One Month After the First Dose|"ALT, AST and TBIL were detected in both groups to determine the liver function of participants. The grade of ALT, AST and TBIL was determined according to the rules issued by CFDA. The fluctuations were classified into three categories: no change indicated no grade change; processed indicated a change from normal to abnormal or an increase in grade; and improved indicated a change from abnormal to normal or a decrease in grade or the change from abnormal to normal."|Day 0-Month 1|All the participants who visited at one month after the first dose.|||Participants|||Count of Participants
2544160|NCT02964247|Secondary|Change in Fasting Blood Lipids - Total Cholesterol|Fasting total cholesterol measured in mg/dL. Observed mean change in fasting total cholesterol from baseline (week 0) to week 26 is presented as ratio to baseline value.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2544128|NCT02964910|Primary|Geometric Mean Concentrations of Anti-HEV Antibody at One Month After The Third Dose|"Measure the level of anti-HEV antibody in serum samples at month 7 to evaluate the immunogenicity of the Hepatitis E vaccine.~Wu/ml：World Health Organization (WHO) units per ml. The WHO standard was used to calibrate the antibody quantitative reference."|Month 7|Totally 192 CHB participants and 196 healthy participants were involved in per-protocol set, who meet the meet the requirements 1) whole-course inoculation, 2)having the results of anti-HEV antibody test before and after immunization, 3) anti-HEV antibody negative before immunization.|||Wu/ml||95% Confidence Interval|Geometric Mean
2544129|NCT02964910|Primary|Number of Participants Whose Anti-HEV Antibody Seroconverted at One Month After The Third Dose|Measure the number of participants whose anti-HEV antibody seroconverted at month 7 to evaluate the immunogenicity of the Hepatitis E vaccine.|Month 7|Totally 192 CHB participants and 196 healthy participants were involved in per-protocol set, who meet the meet the requirements 1) whole-course inoculation, 2)having the results of anti-HEV antibody test before and after immunization, 3) anti-HEV antibody negative before immunization.|||Participants|||Count of Participants
2544130|NCT02964767|Secondary|Comparing CD4+ T Cell Count in HIV-Tb. and HIV Cases.|CD4 cell counts of HIV patients and HIV/co infection patients would be analysed by student T test, and p value would be estimated.|12 months||||cells/µL||Standard Deviation|Mean
2544131|NCT02964767|Primary|Prevalence of HIV/Tb. co Infections Among Patients of HIV Enrolled at ART Center.|% Prevalence of HIV/Tb. co infections= no.of HIV/Tb. co infection (48)/total no. of enrolled patients of HIV including HIV/Tb. co infections (219) x 100, i.e. 21.9%|12 months||||participants|||Number
2544132|NCT02964338|Secondary|Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)|"eC-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent."|Baseline up to Week 12|Safety population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2544133|NCT02964338|Secondary|Number of Participants With Injection Site Reactions|Number of participants who reported treatment-emergent injection site reactions are summarized. Preferred terms from Medical Dictionary for Regulatory Activities (MedDRA) version 18.1 were offered without a threshold applied. Injection site reactions included injection site erythema, induration, pain, haemorrhage, bruising, hypersensitivity, swelling, rash, and flushing. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to Week 12|Safety population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2544134|NCT02964338|Secondary|Number of Participants With Shift From Baseline to Endpoint (Last Assessment) in Electrocardiogram (ECG) Parameters|ECG parameters included: heart rate, PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF), QT interval corrected using the Bazett's formula (QTcB) and RR interval. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding. Missing ECG shift data are also presented. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline to Week 12|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable at the timepoint.|||Participants|||Count of Participants
2544135|NCT02964338|Secondary|Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values|Potentially clinically significant abnormal vital signs findings included: pulse rate ≤50 beats/minute (bpm) and decrease of ≥15 bpm, or ≥120 bpm and increase of ≥15 bpm; systolic blood pressure ≤90 millimeters of mercury (mmHg) and decrease of ≥20 mmHg, or ≥180 mmHg and increase of ≥20 mmHg; diastolic blood pressure ≤50 mmHg and decrease of ≥15 mmHg, or ≥105 mmHg and increase of ≥15 mmHg; respiratory rate <10 breaths/minute; and body temperature ≥38.3 degrees centigrade and change of ≥1.1 degrees centigrade. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to Week 12|Safety population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2544136|NCT02964338|Secondary|Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results|Coagulation parameters included: prothrombin time (PT) (seconds) and prothrombin international normalized ratio (INR). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Shifts from baseline to endpoint were summarized using participant counts grouped into three categories: - Low (below normal range) - Normal (within the normal range of 9.4 to 12.5 seconds) - High (above normal range). Missing PT and prothrombin INR shift data are also presented. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to Week 12|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable at the timepoint.|||Participants|||Count of Participants
2544161|NCT02964247|Secondary|Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes|Treatment emergent hypoglycaemic episode is defined episode with onset on or after the first day of exposure to randomised treatment and no later than the minimum of the date of the follow-up visit or the last day of randomised treatment + 1 days or the date of last subject-investigator contact. Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to American Diabetes Association's (ADA) classification or blood glucose confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions.|Week 0 - 26|Safety analysis set (SAS) includes all subjects exposed to at least one dose of trial product. Subjects in the SAS contribute to the evaluation based on the trial product received for the period they were on-treatment, referred to as contributing to the evaluation ‘as treated’. 'Number Analyzed' = subjects with available data.|||Episodes|||Number
2544137|NCT02964338|Secondary|Number of Participants With Potentially Clinically Significant Laboratory (Serum Chemistry, Hematology, and Urinalysis) Abnormal Results|Serum chemistry, hematology, urinalysis laboratory tests with potentially clinically significant abnormal findings included: Alanine Aminotransferase (units/liter [U/L]) ≥3*upper limit of normal (ULN); Aspartate Aminotransferase (U/L) ≥3*ULN; Bilirubin (Total) ≥34.2 micromole/liter (umol/L); Blood Urea Nitrogen ≥10.71 millimole (mmol)/L; Creatinine ≥177 umol/L; Gamma Glutamyl Transferase (U/L) ≥3*ULN; hemoglobin less than (<)115 grams (g)/L (males) or less than or equal to (≤)95 g/L (females); leukocytes ≥20*10^9/L or ≤3*10^9/L; Eosinophils/Leukocytes ≥10%; Hematocrit <0.37 L/L (males) and <0.32 L/L (females); platelets ≥700*10^9/L or ≤75*10^9/L; blood ≥2 unit increase from baseline; urine glucose (milligrams/decilitre [mg/dL]) ≥2 U increase from baseline; ketones (mg/dL) ≥2 U increase from baseline; urine protein (mg/dL) ≥2 U increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to Week 12|Safety population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2544138|NCT02964338|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the Investigator on a scale of mild, moderate and severe, with severe as an AE that prevents usual activities. Relationship of AE to treatment was determined by the Investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to Week 12|Safety population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2544139|NCT02964338|Secondary|Number of Participants Who Perceived Improvement of CH-Associated Pain From Baseline as Measured by the Patient-Perceived Satisfactory Improvement (PPSI) Scale at Weeks 1, 4, 8, and 12|"The PPSI assessment was developed to measure pain intensity and was adjusted for CH symptoms improvement. Participants marked the level of CH-associated pain and indicated if pain is 1=much worse, 2=moderately worse, 3=slightly worse, 4=unchanged, 5=slightly improved, 6=moderately improved, or 7=much improved compared with 4 weeks prior. PPSI was defined as the change in pain that corresponds with a minimal rating of 5=slightly improved. Data at Week 1 was recorded on Day 7 in the electronic diary device at home. Week 12 data also included assessment at the early withdrawal visit for participants who discontinued the study early."|Baseline and Weeks 1, 4, 8, and 12|Full analysis set included all randomized participants who received at least 1 dose of study drug and had at least 10 days of postbaseline efficacy assessments by the Week 12 assessment.|||Participants|||Count of Participants
2544140|NCT02964338|Secondary|Mean Change From Baseline in the Weekly Average Number of Days Oxygen Was Used to Treat CCH Up to Week 12|Baseline data and the mean change from baseline in the overall weekly average number of days oxygen was used to treat CCH during the 12-week period after administration of the first dose of study drug (based on Week 0 to 12 data) is reported.|Baseline Period (from at least Week -4 to Week 0), Up to Week 12|Full analysis set included all randomized participants who received at least 1 dose of study drug and had at least 10 days of postbaseline efficacy assessments by the Week 12 assessment.|||days of use/week||Standard Deviation|Mean
2544141|NCT02964338|Secondary|Mean Change From Baseline in the Overall Weekly Average Number of Days With Use of Cluster-Specific Acute Headache Medications (Triptans and Ergot Compounds) Up to Week 12|A maximum of 2 concomitant preventive medications for CH were allowed during the study. Participants must have been on a stable dose and regimen of the concomitant medication for at least 2 weeks before screening and throughout the study. Baseline data and the mean change from baseline in the overall weekly average number of days with the use of cluster-specific acute headache medications (triptans and ergot compounds) during the 12-week period after administration of the first dose of study drug (based on Week 0 to 12 data) is reported.|Baseline Period (from at least Week -4 to Week 0), Up to Week 12|Full analysis set included all randomized participants who received at least 1 dose of study drug and had at least 10 days of postbaseline efficacy assessments by the Week 12 assessment.|||days of use/week||Standard Deviation|Mean
2544142|NCT02964338|Secondary|Mean Change From Baseline in the Monthly Average Number of CH Attacks at Week 4 and Week 12|A CH attack was defined as a severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes with either or both of the following 2 categories: 1) ≥1 of the following symptoms or signs, ipsilateral to the headache: -conjunctival injection and/or lacrimation; -nasal congestion and/or rhinorrhea; -eyelid edema; -forehead and facial sweating; -forehead and facial flushing; -sensation of fullness in the ear; -miosis and/or ptosis. 2) a sense of restlessness or agitation. Mean change from baseline in monthly average number of CH attacks during 4-week period after administration of first dose of study drug (based on Week 0 to 4 data) and during 4-week period after administration of third dose of study drug (based on Week 8 to 12 data) is reported.|Baseline Period (from at least Week -4 to Week 0), Week 4 and Week 12|Full analysis set included all randomized participants who received at least 1 dose of study drug and had at least 10 days of postbaseline efficacy assessments by the Week 12 assessment. Here, 'Number analyzed' signifies participants evaluable at specified timepoint.|||CH attacks/month||Standard Deviation|Mean
2544143|NCT02964338|Secondary|Percentage of Participants With a ≥50% Reduction From Baseline in the Monthly Average Number of CH Attacks Up to Week 12|A CH attack was defined as a severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes with either or both of the following 2 categories: 1) at least 1 of the following symptoms or signs, ipsilateral to the headache: -conjunctival injection and/or lacrimation; -nasal congestion and/or rhinorrhea; -eyelid edema; -forehead and facial sweating; -forehead and facial flushing; -sensation of fullness in the ear; -miosis and/or ptosis. 2) a sense of restlessness or agitation.|Baseline Period (from at least Week -4 to Week 0) up to Week 12|Full analysis set included all randomized participants who received at least 1 dose of study drug and had at least 10 days of postbaseline efficacy assessments by the Week 12 assessment.|||percentage of participants|||Number
2547900|NCT02896361|Secondary|Percentage of Participants With Adverse Events||assessed over 6 weeks of study participation||||percentage of patients with AE|||Number
2544144|NCT02964338|Primary|Mean Change From Baseline in the Overall Monthly Average Number of CH Attacks Up to Week 12|A CH attack was defined as a severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes with either or both of the following 2 categories: 1) at least 1 of the following symptoms or signs, ipsilateral to the headache: -conjunctival injection and/or lacrimation; -nasal congestion and/or rhinorrhea; -eyelid edema; -forehead and facial sweating; -forehead and facial flushing; -sensation of fullness in the ear; -miosis and/or ptosis. 2) a sense of restlessness or agitation. Least Squares (LS) mean calculated using analysis of covariance (ANCOVA) model with baseline preventive medication use (yes or no), sex, region (United States [US]/Canada or other), and treatment as fixed effects and the baseline number of CH attacks as a covariate. Change from baseline in the overall monthly average number of CH attacks during the 12-week period after administration of the first dose of study drug (based on Week 0 to 12 data) is reported.|Baseline Period (from at least Week -4 to Week 0), Up to Week 12|Full analysis set included all randomized participants who received at least 1 dose of study drug and had at least 10 days of postbaseline efficacy assessments by the Week 12 assessment.|||CH attacks/month||Standard Error|Least Squares Mean
2544145|NCT02964312|Secondary|Procedure and Device-related Adverse Events|Number of participants who experience procedure- or device-related adverse events.|12 months post procedure||2020-08-31|08/2020||||
2544146|NCT02964312|Secondary|Subject Satisfaction Questionnaire|Participants rate whether they are satisfied or not satisfied with the procedure and cosmetic appearance after the procedure. The percent of participants reporting satisfaction with the procedure is reported.|6 months|All participants who completed a satisfaction questionnaire at the 6-month visit.|||Participants|||Count of Participants
2544147|NCT02964312|Secondary|Change in Nasal Airway Obstruction From Baseline Using a Visual Analog Scale (VAS)|Change from baseline in the nasal obstryction VAS score. Participants provide scores on a scale of 0 (easy to breathe through the nose) to 100 (difficult to breathe through the nose) using a 100-mm line with 1-mm increments).|1,3, 6, 12, 18, and 24 months post procedure||2020-08-31|08/2020||||
2544148|NCT02964312|Secondary|Percent of Treatment Responders|A responder is defined as a participant who has an improvement of at least 1 NOSE class or a NOSE score reduction of at least 20% compared with baseline. NOSE scores can range from0 to 100 with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75) and extreme (80-100).|1, 3, 12, 18, and 24 months post procedure.||2020-08-31|08/2020||||
2544149|NCT02964312|Primary|Safety: Procedure- and/or Device-related Adverse Events|Number of participants with 1 or more adverse events that are determined to be related to the Latera implant and/or procedure.|6 months|All participants who received 1 or more Latera implants.|||Participants|||Count of Participants
2544150|NCT02964312|Primary|Efficacy: Percent of Treatment Responders|A responder is defined as a participant who has an improvement of at least 1 NOSE class or a NOSE score reduction of at least 20% compared with baseline. NOSE scores can range from 0 to 100 with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75) and extreme (80-100).|6 months|All participants who had placement of 1 or more Latera implants and had a 6-month NOSE score.|||Participants|||Count of Participants
2544151|NCT02964247|Secondary|Subjects Who Achieve Weight Loss by 3% or More|Percentage of subjects who achieve HbA1c reduction above or equal to 1% (11mmol/mol) and weight loss above or equal to 3%, after 26 weeks ('in-trial' observation period).|Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||Percentage of participants|||Number
2544152|NCT02964247|Secondary|Change in Diastolic Blood Pressure|Change from baseline (week 0) in diastolic blood pressure after 26 weeks ('in-trial' observation period).|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||mmHg||Standard Deviation|Mean
2544153|NCT02964247|Secondary|Change in Systolic Blood Pressure|Change from baseline (week 0) in systolic blood pressure after 26 weeks ('in-trial' observation period).|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||mmHg||Standard Deviation|Mean
2544154|NCT02964247|Secondary|Change in Waist Circumference|Change from baseline (week 0) to week 26 in waist circumference ('in-trial' observation period).|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||cm||Standard Deviation|Mean
2544155|NCT02964247|Secondary|Change in Fasting Blood Lipids- Free Fatty Acids (FFA)|Free fatty acids measured in mg/dL. Observed mean change in fasting free fatty acids from baseline (week 0) to week 26 is presented as ratio to baseline value.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2544156|NCT02964247|Secondary|Change in Fasting Blood Lipids-triglycerides|Fasting triglycerides measured in mg/dL. Observed mean change in fasting triglycerides from baseline (week 0) to week 26 is presented as ratio to baseline value.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2544157|NCT02964247|Secondary|Change in Fasting Blood Lipids - Very Low Density Lipoprotein (VLDL) Cholesterol|Very low density lipoprotein (VLDL) cholesterol measured in mg/dL. Observed mean change in fasting very low density lipoprotein cholesterol from baseline (week 0) to week 26 is presented as ratio to baseline value.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2544158|NCT02964247|Secondary|Change in Fasting Blood Lipids - High Density Lipoprotein (HDL) Cholesterol|High density lipoprotein (HDL) cholesterol measured in mg/dL. Observed mean change in fasting high density lipoprotein cholesterol from baseline (week 0) to week 26 is presented as ratio to baseline value.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2544159|NCT02964247|Secondary|Change in Fasting Blood Lipids - Low Density Lipoprotein (LDL) Cholesterol|Low density lipoprotein (LDL) cholesterol measured in mg/dL. Observed mean change in fasting low density lipoprotein cholesterol from baseline (week 0) to week 26 is presented as ratio to baseline value.|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2544162|NCT02964247|Secondary|Number of Treatment Emergent Adverse Events|The on-treatment summary of adverse events includes treatment-emergent events with onset on or after the first day of exposure to randomised treatment and no later than the minimum of the date of the follow-up visit or the last day of randomised treatment + 7 days or the date of last subject-investigator contact.|Week 0 - 26 + 7 days|Safety analysis set (SAS) includes all subjects exposed to at least one dose of trial product. Subjects in the SAS contribute to the evaluation based on the trial product received for the period they were on-treatment, referred to as contributing to the evaluation ‘as treated’. 'Number Analyzed' = subjects with available data.|||Events|||Number
2544163|NCT02964247|Secondary|Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) and no Weight Gain|Percentage of subjects who achieve HbA1c reduction above or equal to 1% (11mmol/mol) and no weight gain, after 26 weeks.|Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||Percentage of Participants|||Number
2544164|NCT02964247|Secondary|Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol)|Percentage of subjects who achieve HbA1c reduction above or equal to 1% (11mmol/mol), after 26 weeks ('in-trial' observation period)|Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||Percentage of Participants|||Number
2544165|NCT02964247|Secondary|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), no Weight Gain and Systolic Blood Pressure Below 140 mmHg.|Percentage of subjects who achieve HbA1c below 7.0% (53 mmol/mol), no weight gain and systolic blood pressure below 140 mmHg, after 26 weeks ('in-trial' observation period)|Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||Percentage of Participants|||Number
2544166|NCT02964247|Secondary|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain|Percentage of subjects who achieve HbA1c below 7.0% (53 mmol/mol) and no weight gain, after 26 week ('in-trial' observation period).|Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||Percentage of Participants|||Number
2544167|NCT02964247|Secondary|Change in Body Mass Index (BMI)|Observed mean change from baseline (week 0) to week 26 in body mass index (BMI). BMI was calculated based on body weight and height ('in-trial' observation period)|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||kg/m^2||Standard Deviation|Mean
2544168|NCT02964247|Secondary|Change in Self-measured Plasma Glucose 7-point Profile - Mean Post Prandial Increments (Over All Meals)|Subjects were instructed to measure their plasma glucose at following 7 timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime. The mean increment over all meals was derived as the mean of all available meal increments ('in-trial' observation period)|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||milligram/dL||Standard Deviation|Mean
2544169|NCT02964247|Secondary|Change in Self-measured Plasma Glucose 7-point Profile - Mean 7-point Profile|Change in self-measured plasma glucose 7-point profile - mean 7-point profile after 26 weeks. Subjects were instructed to measure their plasma glucose at following 7 timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime. Mean of the 7-point profile was calculated ('in-trial' observation period).|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||milligram/dL||Standard Deviation|Mean
2544170|NCT02964247|Secondary|Subjects Who Achieve HbA1c Reduction Above or Equal to 1% (11mmol/Mol) and Weight Loss Above or Equal to 3%.|Percentage of subjects who achieve HbA1c reduction above or equal to 1% (11mmol/mol) and weight loss above or equal to 3%, after 26 weeks ('in-trial' observation period)|Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||Percentage of Participants|||Number
2544171|NCT02964247|Secondary|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain.|Percentage of subjects who achieve HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain, after 26 weeks ('in-trial' observation period)|Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||Percentage of Participants|||Number
2544172|NCT02964247|Secondary|Subjects Who Achieve HbA1c Below or Equal to 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists Target|Percentage of subjects who achieve HbA1c below or equal to 6.5% (48 mmol/mol), American Association of Clinical Endocrinologists target, after 26 weeks ('in-trial' observation period)|Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||Percentage of Participants|||Number
2544173|NCT02964247|Secondary|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol), American Diabetes Association Target|Percentage of subjects who achieve HbA1c below 7.0% (53 mmol/mol), American Diabetes Association target, after 26 weeks ('in-trial' observation period)|Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||Percentage of Participants|||Number
2544174|NCT02964247|Secondary|Change in Fasting Plasma Glucose|Change from baseline (week 0) to week 26 in fasting plasma glucose ('in-trial' observation period)|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||milligram/dL||Standard Deviation|Mean
2544175|NCT02964247|Secondary|Change in Body Weight|"Change from baseline (week 0) to week 26 in body weight was evaluated for 2 different observation period 'in-trial' observation period and 'on-treatment without rescue medication observation period. The 'in-trial' observation period represents the time-period where subjects were considered to be in the trial, regardless of whether or not the subjects had initiated rescue medication or prematurely discontinued trial product. The 'on-treatment' observation period is the part of the in-trial observation period during which subjects were treated with the trial product, that is the time from the first dose to the last dose of trial product. The 'on-treatment without rescue medication' observation period is a part of 'on-treatment' observation period during which subjects were considered treated with trial product and had not initiated any rescue medications."|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||Kg||Standard Deviation|Mean
2544176|NCT02964247|Primary|Change in HbA1c|"Change from baseline (week 0) to week 26 in glycosylated haemoglobin was evaluated for 2 different observation period 'in-trial' observation period and 'on-treatment without rescue medication observation period. The 'in-trial' observation period represents the time-period where subjects were considered to be in the trial, regardless of whether or not the subjects had initiated rescue medication or prematurely discontinued trial product. The 'on-treatment' observation period is the part of the in-trial observation period during which subjects were treated with the trial product, that is the time from the first dose to the last dose of trial product. The 'on-treatment without rescue medication' observation period is a part of 'on-treatment' observation period during which subjects were considered treated with trial product and had not initiated any rescue medications."|Week 0, Week 26|Full analysis set (FAS) includes all randomised subjects. 'Number Analyzed' = subjects with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2544177|NCT02964078|Secondary|Progression Free Survival (PFS)|Progression-free survival (PFS) of ITT patients using Kaplan Meier estimate, from the confirmed eligible date to the first occurrence of disease progression or death, from any cause, or lost to follow up, whichever is earliest; or censored at last follow-up during study. Progressive Disease (PD): At least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 weeks apart.|Up to 24 months||||proportion of participants||95% Confidence Interval|Number
2544178|NCT02964078|Secondary|Overall Survival (OS) of Intent to Treat (ITT) Population|Analysis: Overall Survival (OS) of ITT patients using Kaplan-Meier estimate, counting from the eligible date to death from any cause, or censored on end of known follow up, either within this study or in the Prometheus Laboratories sponsored PROCLAIM registry (PROCLAIM Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy, NCT01415167).|Up to 24 months||||proportion of participants||95% Confidence Interval|Number
2544179|NCT02964078|Primary|Overall Response Rate (ORR)|Overall Response According to Immune-related response criteria (irRC). Overall response rate ORR is defined with confirmation of the response status Complete Response (CR) or Partial Response (PR) among the combination treatment population patients; the binomial estimate and its one-sided 95% confidence interval will be reported. CR: Disappearance of all lesions in two consecutive observation not less than 4 weeks apart. PR: ≥50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart.|Up to 24 months||||percentage of participants||90% Confidence Interval|Median
2544180|NCT02963987|Secondary|Differences in Food and Beverage Intake by Weight|Differences between 100% and 150% portion size conditions in daily weighed intake of food and beverages (g)|Days 1-5 in Periods 1 and 2|Data of 4 enrolled participants was excluded from analysis for absence from meals on 3 or more days in one intervention period|||grams||Standard Error|Mean
2544181|NCT02963987|Secondary|Differences in Food and Beverage Intake by Energy Density|Differences between 100% and 150% portion size conditions in daily energy density (kcal/g) determined from weighed intakes of food and beverages|Days 1-5 in Periods 1 and 2|Data of 4 enrolled participants was excluded from analysis for absence from meals on 3 or more days in one intervention period|||kilocalories/gram||Standard Error|Mean
2544182|NCT02963987|Primary|Differences in Food and Beverage Intake by Energy|Differences between 100% and 150% portion size conditions in energy intake (kcal) determined from weighed intakes of food and beverages|Days 1-5 in Periods 1 and 2|Data of 4 enrolled participants was excluded from analysis for absence from meals on 3 or more days in one intervention period.|||kilocalories||Standard Error|Mean
2544183|NCT02963935|Secondary|Change in Laboratory Measurements: Biochemistry (Thyroid Stimulating Hormone)|Observed mean change from baseline in biochemical parameters - thyroid stimulating hormone. Results based on SAS on-drug data is presented.|Week 0, week 56|"Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. Number analysed=subjects with available data."|||mIU/L||Standard Deviation|Mean
2544184|NCT02963935|Secondary|Change in Laboratory Measurements: Biochemistry (Calcitonin)|Observed mean change from baseline in biochemical parameter - calcitonin. Results based on SAS on-drug data is presented.|Week 0, week 56|"Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. Number analysed=subjects with available data."|||ng/L||Standard Deviation|Mean
2544185|NCT02963935|Secondary|Change in Laboratory Measurements: Biochemistry (Glomerular Filtration Rate, Serum)|Observed mean change from baseline in biochemical parameters - estimated glomerular filtration rate. Serum GFR is estimated using MDRD formula . Results based on SAS on-drug data is presented.|Week 0, week 56|"Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. Number analysed=subjects with available data."|||mL/min/1.73m^2||Standard Deviation|Mean
2544186|NCT02963935|Secondary|Change in Laboratory Measurements: Biochemistry (C-reactive Protein and Uric Acid)|Observed mean change from baseline in biochemical parameters - high sensitive c-reactive protein and uric acid. Results based on SAS on-drug data is presented.|Week 0, week 56|"Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. Number analysed=subjects with available data."|||mg/dL||Standard Deviation|Mean
2544187|NCT02963935|Secondary|Change in Laboratory Measurements: Biochemistry (Total Calcium, Pottassium, Sodium and Urea)|Observed mean change from baseline in biochemical parameters - total calcium, pottassium, sodium and urea. Results based on SAS on-drug data is presented.|Week 0, week 56|"Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. Number analysed=subjects with available data."|||mmol/L||Standard Deviation|Mean
2544188|NCT02963935|Secondary|Change in Laboratory Measurements: Biochemistry (Bilirubin and Creatinine)|Observed mean change from baseline in biochemical parameters - bilirubin and creatinine. Results based on SAS on-drug data is presented.|Week 0, week 56|"Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. Number analysed=subjects with available data."|||umol/L||Standard Deviation|Mean
2544189|NCT02963935|Secondary|Change in Laboratory Measurements: Biochemistry (Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase)|Observed mean change from baseline in biochemical parameters - alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase and lipase. Results based on SAS on-drug data is presented.|Week 0, week 56|"Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. Number analysed=subjects with available data."|||U/L||Standard Deviation|Mean
2544191|NCT02963935|Secondary|Change in Laboratory Measurements: Haematology (Thrombocytes and Leukocytes)|Observed mean change from baseline in haematological parameters - thrombocytss and leukocytes.|Week 0, week 56|"Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. Number analysed=subjects with available data."|||10^9 cells/L||Standard Deviation|Mean
2544192|NCT02963935|Secondary|Change in Laboratory Measurements: Haematology (Erythrocytes)|Observed mean change from baseline in haematological parameter - erythrocytes.|Week 0, week 56|"Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. Number analysed=subjects with available data."|||10^12 cells/L||Standard Deviation|Mean
2544193|NCT02963935|Secondary|Change in Laboratory Measurements: Haematology (Haematocrit Blood)|Observed mean change from baseline in haematological parameter blood haematocrit. Haematocrit is presented as the percentage of red blood cells in total blood. Results based on SAS on-drug data is presented.|Week 0, week 56|"Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. Number analysed=subjects with available data."|||percentage of red blood cells||Standard Deviation|Mean
2544194|NCT02963935|Secondary|Change in Laboratory Measurements: Haematology (Haemoglobin Blood)|Observed mean change from baseline in haematological parameter blood haemoglobin.|Week 0, week 56|"Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. Number analysed=subjects with available data."|||mmol/L||Standard Deviation|Mean
2544195|NCT02963935|Secondary|Change in ECG|The ECGs were interpreted by the investigator at baseline (week -1) and week 56 and categorised as normal, abnormal NCS or abnormal CS. Number of subjects in each ECG category at baseline and week 56 are presented.|Week -1, week 56|"Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. Number analysed=subjects with available data."|||participants|||Number
2544196|NCT02963935|Secondary|Change in Resting Pulse|Observed mean change in pulse rate measured at resting position is presented.|Week 0, week 56|"Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. Number analysed=subjects with available data."|||beats/min||Standard Deviation|Mean
2544197|NCT02963935|Secondary|Change in Physical Examination|Observed change from baseline to week 56 in physical examination are categorised under parameters namely abdomen, gastrointestinal system, cardiovascular system, central and peripheral nervous system, general appearence, head, ears, eyes, nose, throat and neck, lymph node palpation, musculoskeletal system, respiratory system, skin and thyroid gland. The percentage of subjects assessed as normal, abnormal not clinically significant and abnormal clinically significant at baseline and week 56 is presented.|Week 1, week 56|"Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. Number analysed=subjects with available data."|||participants|||Number
2544198|NCT02963935|Secondary|AEs From Randomisation Until and Including the Follow-up Period|Number of adverse events from randomisation to until the end of the post-treatment follow-up period (30 days). Results based on SAS on-drug data is presented.|Week 0 to week 56+30 days|"Safety analysis set included all randomised subjects exposed to at least one dose of trial drug. Number analysed=subjects with available data."|||events|||Number
2544199|NCT02963935|Secondary|Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet, Physical Activity and Trial Product|Adherence to caloric diet, physical activity and trial product is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet, physical activity and trial product is presented.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||weeks||Standard Deviation|Mean
2544200|NCT02963935|Secondary|Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet and Physical Activity|Adherence to caloric diet and physical activity is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet and physical activity is presented.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||weeks||Standard Deviation|Mean
2544201|NCT02963935|Secondary|Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Physical Activity|Adherence to physical activity is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to physical activity is presented.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||weeks||Standard Deviation|Mean
2544202|NCT02963935|Secondary|Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Caloric Diet|Adherence to caloric diet is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to caloric diet is presented.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||weeks||Standard Deviation|Mean
2544203|NCT02963935|Secondary|Number of Weeks (Completed Calendar Weeks) From Randomisation to Week 56 Adherent to Trial Product|Adherence to trial product is assessed regularly at CMS-IBT visits. The number of weeks from randomisation to week 56, adherent to trial product is presented.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||weeks||Standard Deviation|Mean
2544204|NCT02963935|Secondary|Responder Definition Value for IWQoL-Lite for CT Physical Function Domain (5-items) Score|Responder definition value for IWQoL-Lite for CT physical function domain (5-items) score' was defined as '≥ 20 responder definition value for IWQoL-Lite for CT physical function domain (5-items) score. Percentage of subjects considered IWQoL-Lite for CT physical function domain score responders (increase of ≥20 points) at week 56 is presented. Results based on FAS in-trial data is presented.|Week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||Percentage of participants|||Number
2544205|NCT02963935|Secondary|Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.6 T-score Points Increase From Baseline in SF-36 Mental Component Score|Percentage of subjects who achieved ≥ 4.6 T-score points increase from baseline in SF-36 mental component score at week 56 is presented. Results based on FAS in-trial data is presented.|Week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||Percentage of participants|||Number
2544216|NCT02963935|Secondary|Change From Baseline in Lipids - TG|Observed mean change from baseline in triglyceride (TG) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||mmol/L||Standard Deviation|Mean
2544206|NCT02963935|Secondary|Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 3.8 T-score Points Increase From Baseline in SF-36 Physical Component Score|Percentage of subjects who achieved ≥ 3.8 T-score points increase from baseline in SF-36 physical component score at week 56 is presented. Results based on FAS in-trial data is presented.|Week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||Percentage of participants|||Number
2544207|NCT02963935|Secondary|Subjects Who After 56 Weeks Achieve (Yes/no): ≥ 4.3 T-score Points Increase From Baseline in SF-36 Physical Functioning Score|Percentage of subjects who achieved ≥ 4.3 T-score points increase from baseline in SF-36 physical functioning score at week 56 is presented. Results based on FAS in-trial data is presented.|Week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||percentage of participants|||Number
2544208|NCT02963935|Secondary|Change in Weight Related Sign and Symptom (WRSS) Measure, Total Score|"Observed mean change from baseline (week 0) to week 56 in WRSS measure, total score. The WRSS measures the presence and bothersome associated with weight-related symptoms.~The WRSS questionnaire was not validated until after database lock. Therefore the total score couldn't be calculated and the supportive secondary endpoint Weight related sign and symptom (WRSS) measure, total score couldn't be analysed."|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||Score on a scale||Standard Deviation|Mean
2544209|NCT02963935|Secondary|Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Total Score|Observed mean change from baseline (week 0) to week 56 in IWQoL-Lite for CT total score. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. Results based on FAS in-trial data is presented.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||scores on a scale||Standard Deviation|Mean
2544210|NCT02963935|Secondary|Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Psychosocial Domain Score|Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT) psychosocial domain. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. Results based on FAS in-trial data is presented.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||score||Standard Deviation|Mean
2544211|NCT02963935|Secondary|Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT): Pain/Discomfort Domain Score|Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT) domain pain and discomfort. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. Results based on FAS in-trial data is presented.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||scores on a scale||Standard Deviation|Mean
2544212|NCT02963935|Secondary|Change in Short Form-36 v2.0 Acute (SF-36) (Mental Component Summary (MCS)|Observed mean change from baseline (week 0) to week 56 in short form 36 v2.0 acute domain mental component summary (MCS). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in SF-36 mental component summary is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||scores on a scale||Standard Deviation|Mean
2544213|NCT02963935|Secondary|Change in Short Form-36 v2.0 Acute (SF-36) (Physical Component Summary (PCS))|Observed mean change from baseline (week 0) to week 56 in short form 36 v2.0 acute domain physical component summary (PCS). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in SF-36 physical component summary (PCS) score is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||scores on a scale||Standard Deviation|Mean
2544214|NCT02963935|Secondary|Change in Short Form-36 v2.0 Acute (SF-36) (Subdomains)|"SF-36 is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL).~SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in in the sub-domain scores is presented. A positive change score indicates an improvement since baseline. Results are evaluated based on in-trial data."|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||scores on a scale||Standard Deviation|Mean
2544215|NCT02963935|Secondary|Change From Baseline in Lipids - FFA|Observed mean change from baseline in free fatty acids (FFA) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||mmol/L||Standard Deviation|Mean
2544217|NCT02963935|Secondary|Change From Baseline in Lipids - VLDL Cholesterol|Observed mean change from baseline in very low density cholesterol (VLDL) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||mmol/L||Standard Deviation|Mean
2544218|NCT02963935|Secondary|Change From Baseline in Lipids - HDL Cholesterol|Observed mean change from baseline in high density (HDL) cholesterol from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||mmol/L||Standard Deviation|Mean
2544219|NCT02963935|Secondary|Change From Baseline in Lipids - LDL Cholesterol|Observed mean change from baseline in low density cholesterol (LDL) from baseline (week 0) to week 56. Results based on FAS in-trial data is presented.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||mmol/L||Standard Deviation|Mean
2544220|NCT02963935|Secondary|Change From Baseline in Lipids -Total Cholesterol|Observed mean change from baseline (week 0) to week 56 in total cholesterol (TC). Results based on FAS in-trial data is presented.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||mmol/L||Standard Deviation|Mean
2544221|NCT02963935|Secondary|Change From Baseline dBP (mmHg)|Observed mean change from baseline (week 0) to week 56 in diastolic blood pressure (dBP). Results based on FAS in-trial data is presented.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||mmHg||Standard Deviation|Mean
2544222|NCT02963935|Secondary|Change From Baseline sBP (mmHg)|Observed mean change in systolic blood pressure from baseline to week 56.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||mmHg||Standard Deviation|Mean
2544223|NCT02963935|Secondary|Change From Baseline in FPG (mg/dL)|Observed mean change from baseline (week 0) in fasting plasma glucose (FPG). Results based on FAS in-trial data is presented.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||mg/dL||Standard Deviation|Mean
2544224|NCT02963935|Secondary|Change From Baseline in HbA1c (%)|Observed mean change from baseline to week 56 in glycosylated haemoglobin (HbA1c). Results based on FAS in-trial data is presented.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||percentage||Standard Deviation|Mean
2544225|NCT02963935|Secondary|Change in Six Minutes Walking Distance Test (6MWT)|Observed mean change from baseline in 6 minutes walking distance test. The 6MWT is a common test of functional exercise capacity that assesses the distance a subject can walk in 6 minutes. The endpoint was evaluated based on in-trial data and on-drug data.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||meter||Standard Deviation|Mean
2544226|NCT02963935|Secondary|Change in IWQoL-Lite for CT, Physical Function Domain (5-items) Score|"Observed mean change in Impact of Weight on Quality of Life-Lite for Clinical Trials Version (IWQoL-Lite for CT ) score. IWQoL-Lite for CT (Weight on Quality of Life-Lite for Clinical Trial Version) is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life.~The endpoint was evaluated based on in-trial data and on-drug data."|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||Scores on a scale||Standard Deviation|Mean
2544227|NCT02963935|Secondary|Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score|"SF-36 is a 36-item patient-reported survey of patient health that measures the subject's overall health-related quality of life (HRQoL).~SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in SF-36 physical functioning score is presented. A positive change score indicates an improvement since baseline. The endpoint was evaluated based on in-trial data and on-drug data."|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||Scores on a scale||Standard Deviation|Mean
2544228|NCT02963935|Secondary|Change in Waist Circumference (cm)|Observed mean change from baseline in waist circumference. The endpoint was evaluated based on in-trial data and on-drug data.|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||cm||Standard Deviation|Mean
2544229|NCT02963935|Secondary|Proportion of Subjects Losing 4% or More of Baseline Body Weight|The estimated mean percentage of subjects losing 4% or more of baseline body weight at week 16 is presented. The endpoint was evaluated for treatment policy estimand (in-trial data).|Week 16|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||percentage of participants|||Number
2544230|NCT02963935|Secondary|Proportion of Subjects Losing More Than 15% of Baseline Body Weight at Week 56|The estimated mean percentage of subjects losing more than 15% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data.|Week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||percentage of participants|||Number
2544231|NCT02963935|Secondary|Proportion of Subjects Losing More Than 10% of Baseline Body Weight at Week 56|The estimated mean percentage of subjects losing more than 10% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data.|Week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||percentage of participants|||Number
2544232|NCT02963935|Primary|Proportion of Subjects Losing at Least 5% of Baseline Body Weight at Week 56|The estimated mean percentage of subjects losing at least 5% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data.|Week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||percentage of participants|||Number
2544632|NCT02957747|Primary|30-day Alcohol Timeline Follow Back|Calendar-assisted measure used to garner a retrospective account of drinking behavior. Scale is in standard alcoholic drinks in an average week in the past month. Higher numbers indicate more drinks per week (i.e., worse outcome).|4 month follow-up||||Drinks per week in the past month||Standard Deviation|Mean
2544233|NCT02963935|Primary|Change in Body Weight (%)|"Observed mean change in body weight from baseline (week 0) to week 56 was evaluated for two different observation periods. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which subjects are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).~The test of superiority of liraglutide to placebo for the treatment policy estimand was tested in a hierarchical manner for the two primary and the consequent 7 confirmatory secondary endpoints presented."|Week 0, week 56|"Full analysis set included all randomised subjects. Number analysed=subjects with available data."|||percent change||Standard Deviation|Mean
2544234|NCT02963922|Secondary|Change in Laboratory Parameters (Biochemistry) - Thyroid Stimulating Hormone|Change from baseline (week 0) to week 56 in thyroid stimulating hormone was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data."|||Milli-international units per liter||Standard Deviation|Mean
2544235|NCT02963922|Secondary|Change in Laboratory Parameters (Biochemistry) - Calcitonin|Change from baseline (week 0) to week 56 in calcitonin was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data."|||Nanograms per liter (ng/L)||Standard Deviation|Mean
2544236|NCT02963922|Secondary|Change in Laboratory Parameters (Biochemistry) - Uric Acid|Change from baseline (week 0) to week 56 in uric acid was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data."|||mg/dL||Standard Deviation|Mean
2544237|NCT02963922|Secondary|Change in Laboratory Parameters (Biochemistry) - eGFR|Change from baseline (week 0) to week 56 in estimated GFR serum using Modification of Diet in Renal Disease (MDRD) formula was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data."|||Milliliters per minute per 1.73m^2||Standard Deviation|Mean
2544238|NCT02963922|Secondary|Change in Laboratory Parameters (Biochemistry) - High Sensitive C-reactive Protein|Change from baseline (week 0) to week 56 in high sensitive C-reactive protein was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data."|||Milligrams per liter (mg/L)||Standard Deviation|Mean
2544239|NCT02963922|Secondary|Change in Laboratory Parameters (Biochemistry) - Total Bilirubin and Creatinine|Change from baseline (week 0) to week 56 in total bilirubin and creatinine was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data."|||Micromoles per liter (umol/L)||Standard Deviation|Mean
2544240|NCT02963922|Secondary|Change in Laboratory Parameters (Biochemistry) - Bicarbonate, Total Calcium, Potassium, Sodium and Urea|Change from baseline (week 0) to week 56 in bicarbonate, total calcium, potassium, sodium and urea was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data."|||mmol/L||Standard Deviation|Mean
2544241|NCT02963922|Secondary|Change in Laboratory Parameters (Biochemistry) - Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase and Lipase|Change from baseline (week 0) to week 56 in alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase and lipase was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data."|||Units per liter (U/L)||Standard Deviation|Mean
2544242|NCT02963922|Secondary|Change in Laboratory Parameters (Biochemistry) - Albumin|Change from baseline (week 0) to week 56 in albumin was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data."|||Grams per deciliter (g/dL)||Standard Deviation|Mean
2544243|NCT02963922|Secondary|Change in Laboratory Measurements (Haematology) - Thrombocytes, Leukocytes|Change from baseline (week 0) to week 56 in thrombocytes and leukocytes was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data."|||10^9 cells/L||Standard Deviation|Mean
2544294|NCT02963597|Secondary|E/e' as an Assumption of LVEDP.|Measurement of E/e' in 2D echocardiography as an assumption of LVEDP and PV acceleration time comparing baseline and after 48hrs.|48 hours|Data was not available for all the subjects at baseline and 48 hours after. PI has left the institution; efforts to contact unsuccessful; clarifying data information not available|||Ratio||95% Confidence Interval|Mean
2544244|NCT02963922|Secondary|Change in Laboratory Measurements (Haematology) - Erythrocytes|Change from baseline (week 0) to week 56 in erythrocytes was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data."|||10^12 cells per liter (10^12 cells/L)||Standard Deviation|Mean
2544245|NCT02963922|Secondary|Change in Laboratory Measurements (Haematology) - Haematocrit|Change from baseline (week 0) to week 56 in Haematocrit was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data."|||Percentage of red blood cells||Standard Deviation|Mean
2544246|NCT02963922|Secondary|Change in Laboratory Measurements (Haematology) - Haemoglobin|Change from baseline (week 0) to week 56 in haemoglobin was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data."|||mmol/L||Standard Deviation|Mean
2544247|NCT02963922|Secondary|Change in Electrocardiogram (ECG)|The ECGs were interpreted by the investigator at baseline (week -1) and week 56 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 56 were presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week -1, week 56|"SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data."|||Participants|||Count of Participants
2544248|NCT02963922|Secondary|Change in Resting Pulse|Change from baseline (week -1) to week 56 in resting pulse was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week -1, week 56|"SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed = participants with available data."|||Beats/minute||Standard Deviation|Mean
2544249|NCT02963922|Secondary|Change in Physical Examination|Physical examination parameters are categorised as abdomen; gastrointestinal system; cardiovascular system; central and peripheral nervous system; general appearance; head, eyes, ears, nose, throat (ENT) and neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -1) and week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week -1, week 56|"SAS included all randomised participants exposed to at least one dose of trial drug. Number analyzed=participants with available data."|||Participants|||Count of Participants
2544250|NCT02963922|Secondary|Number of Hypoglycaemic Episodes|Number of hypoglycaemic episodes was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0 to week 56 + 30 days|SAS included all randomised participants exposed to at least one dose of trial drug.|||Hypoglycaemic episodes|||Number
2544251|NCT02963922|Secondary|Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. Number of AEs from randomisation to until the end of the post-treatment follow-up period (30 days). Results based on in-trial data was presented. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0 to week 56 + 30 days|Safety analysis set (SAS) included all randomised participants exposed to at least one dose of trial drug.|||Adverse events|||Number
2544252|NCT02963922|Secondary|Responder Definition Value for IWQoL-Lite for CT Physical Function Domain Score|Percentage of participants who achieve responder definition value for IWQoL-Lite for CT physical function domain score was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 56|Full analysis set included all randomised participants.|||Percentage of participants|||Number
2544253|NCT02963922|Secondary|Participants Who Achieved (Yes/no): ≥4.6 T-score Points Increase From Baseline in SF-36 Acute MCS|Percentage of participants who achieved ≥4.6 T-score points increase from baseline in SF-36 acute MCS at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 56|Full analysis set included all randomised participants.|||Percentage of participants|||Number
2544254|NCT02963922|Secondary|Participants Who Achieved (Yes/no): ≥3.8 T-score Points Increase From Baseline in SF-36 Acute PCS|Percentage of participants who achieved ≥3.8 T-score points increase from baseline in SF-36 acute PCS at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 56|Full analysis set included all randomised participants.|||Percentage of participants|||Number
2544255|NCT02963922|Secondary|Participants Who Achieved (Yes/no): ≥4.3 T-score Points Increase From Baseline in SF-36 Acute Physical Functioning Score|Percentage of participants who achieved ≥4.3 T-score points increase from baseline in SF-36 acute physical functioning score at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 56|Full analysis set included all randomised participants.|||Percentage of participants|||Number
2544295|NCT02963597|Secondary|Fluid Retention|Change in fluid retention as measured by weight at baseline and after 48 hours.|48 hours|Data after 48 hours was not available for the participants of the study. PI has left the institution; efforts to contact unsuccessful; data information not available for after 48hr time point|||Kg||95% Confidence Interval|Mean
2544256|NCT02963922|Secondary|Participants Who Achieved (Yes/no): HbA1c <7%, Weight Loss ≥5% and no Documented Symptomatic Hypoglycaemia|Percentage of participants who achieved HbA1c <7%, weight loss ≥5% from baseline and no documented symptomatic hypoglycaemia at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 56|Full analysis set included all randomised participants.|||Percentage of participants|||Number
2544257|NCT02963922|Secondary|Participants Who Achieved (Yes/no): HbA1c <7% and Weight Loss ≥5%|Percentage of participants who achieved HbA1c <7% and weight loss ≥5% from baseline at week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 56|Full analysis set included all randomised participants.|||Percentage of participants|||Number
2544258|NCT02963922|Secondary|Weight Related Sign and Symptom (WRSS) Measure, Categorical Responses|The WRSS measure is a questionnaire under development. The version applied in this study has 10 items that measure the presence and bothersomeness of 10 weight-related symptoms. Each item has a categorical part with answers on the following 5 possible levels: 'Never/Almost never', 'Rarely', 'Sometimes', 'Often' and 'Almost always/Always'. Number of participants in each category at baseline (week 0) and week 56 was presented. Scoring algorithm was not available prior to database lock and therefore it was decided and documented in the statistical analysis plan that WRSS total score was not to be calculated and analyzed.|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||Participants|||Count of Participants
2544259|NCT02963922|Secondary|Change in IWQoL-Lite for CT: Total Score|Change in IWQoL-Lite for CT total score from baseline (week 0) to week 56 was presented based on in-trial data. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||Score on a scale||Standard Deviation|Mean
2544260|NCT02963922|Secondary|Change in IWQoL-Lite for CT: Psychosocial Domain Score|Change in IWQoL-Lite for CT psychosocial domain from baseline (week 0) to week 56 was presented based on in-trial data. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||Score on a scale||Standard Deviation|Mean
2544261|NCT02963922|Secondary|Change in IWQoL-Lite for CT: Pain/Discomfort Domain Score|Change in IWQoL-Lite for CT pain and discomfort domain from baseline (week 0) to week 56 was presented based on in-trial data. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||Score on a scale||Standard Deviation|Mean
2544262|NCT02963922|Secondary|Change in SF-36: Mental Component Summary (MCS)|Change in short form 36 v2.0 acute domain mental component summary (MCS) from baseline (week 0) to week 56 was presented based on in-trial data. SF- 36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||Score on a scale||Standard Deviation|Mean
2544263|NCT02963922|Secondary|Change in SF-36: Physical Component Summary (PCS)|Change in short form 36 v2.0 acute domain physical component summary (PCS) from baseline (week 0) to week 56 was presented based on in-trial data. SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. It consists of 2 component summary measures that further summarize 8 health domain scales. The physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||Score on a scale||Standard Deviation|Mean
2544264|NCT02963922|Secondary|Change in SF-36: Sub-domains|SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores was presented based on in-trial data. A positive change score indicates an improvement since baseline. Results are presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||Score on a scale||Standard Deviation|Mean
2544265|NCT02963922|Secondary|Change in Lipids -Total Cholesterol, HDL, LDL, VLDL, Triglycerides and FFA|Change in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very low density lipoprotein (VLDL) cholesterol, triglycerides and free fatty acids (FFA) from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||mmol/L||Standard Deviation|Mean
2544266|NCT02963922|Secondary|Change in sBP and dBP|Change in systolic blood pressure (sBP) and diastolic blood pressure (dBP) from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2544267|NCT02963922|Secondary|Change in 7-point SMPG Profile Mean Daytime Glucose Value|Participants measured plasma glucose values using the blood glucose meter at 7 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner and at bedtime. Change from baseline (week 0) to week 56 in 7-point self-measured plasma glucose (SMPG) profile mean daytime glucose value was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||mmol/L||Standard Deviation|Mean
2544268|NCT02963922|Secondary|Change in Total Daily Insulin Dose (U/kg)|Change in total daily insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||U/kg||Standard Deviation|Mean
2544269|NCT02963922|Secondary|Change in Total Daily Basal Insulin Dose (U/kg)|Change in total daily basal insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||Units of insulin dose per kilogram(U/kg)||Standard Deviation|Mean
2544270|NCT02963922|Secondary|Change in Total Daily Basal Insulin Dose (% of Pre-trial Dose in U)|Change in total daily basal insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||Percentage change||Standard Deviation|Mean
2544271|NCT02963922|Secondary|Change in Total Daily Insulin Dose (U)|Change in total daily insulin dose from baseline (week 0) to week 56 was presented based on in-trial data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact.|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||Units of insulin dose (U)||Standard Deviation|Mean
2544272|NCT02963922|Secondary|Change in Impact of Weight on Quality of Life-Lite for Clinical Trial Version (IWQoL-Lite for CT), Physical Function Domain (5-items) Score|Change in IWQoL-Lite for CT physical function domain (5-items) score. IWQoL-Lite for CT is a modified version of an instrument designed to assess weight-related quality of life. The scores ranged between 0-100 where higher scores indicated a better quality of life. A positive change score indicates an improvement since baseline. The endpoint was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||Score on a scale||Standard Deviation|Mean
2544273|NCT02963922|Secondary|Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score|SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline (week 0) in SF-36 physical functioning score was presented based on in-trial data and on-drug data. A positive change score indicates an improvement since baseline.|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||Score on a scale||Standard Deviation|Mean
2544274|NCT02963922|Secondary|Change in FPG|Change in fasting plasma glucose (FPG) from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2544633|NCT02957747|Primary|PCL-5|Symptoms of PTSD. Score range 0-80; higher scores indicate more PTSD symptoms (i.e., worse outcome).|2 month follow up||||score on a scale||Standard Deviation|Mean
2544275|NCT02963922|Secondary|Change in HbA1c|Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||Percentage of HbA1c||Standard Deviation|Mean
2544276|NCT02963922|Secondary|Change in Waist Circumference|Change in waist circumference from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||Centimeters (cm)||Standard Deviation|Mean
2544277|NCT02963922|Secondary|Participants Losing More Than 10% of Baseline Body Weight at Week 56|The estimated percentage of participants losing more than 10% of baseline (week 0) body weight at week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events [AEs]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).|Week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||Percentage of participants|||Number
2544278|NCT02963922|Primary|Participants Losing at Least 5% of Baseline Body Weight|The estimated percentage of participants losing at least 5% of baseline (week 0) body weight at week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events [AEs]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).|Week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||Percentage of participants|||Number
2544279|NCT02963922|Primary|Change in Body Weight (%)|Change in body weight from baseline (week 0) to week 56 was presented based on in-trial data and on-drug data. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which participants are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for adverse events [AEs]) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs).|Week 0, week 56|"Full analysis set included all randomised participants. Number analyzed=participants with available data."|||Percentage change||Standard Deviation|Mean
2544280|NCT02963701|Secondary|S/R-ibuprofen Ratio for AUC0-tz|AUC0-tz S-ibuprofen / AUC0-tz R-ibuprofen|Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.|Pharmacokinetic Population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2544281|NCT02963701|Secondary|Cmax of S-Ibuprofen|This outcome is maximum measured concentration of the S-Ibuprofen in plasma|Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.|Pharmacokinetic population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2544282|NCT02963701|Secondary|AUC0-∞ of S-Ibuprofen|This endpoint calculates area under the concentration-time curve of S-Ibuprofen in plasma over the time interval from 0 extrapolated to infinity|Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.|Pharmacokinetic Population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2544283|NCT02963701|Secondary|AUC0-tz of S-Ibuprofen|This endpoint calculates area under the concentration-time curve of S-Ibuprofen in plasma over the time interval from 0 to the time of last quantifiable time point.|Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.|Pharmacokinetic Population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2544284|NCT02963701|Secondary|Cmax of R-Ibuprofen|This outcome is maximum measured concentration of the R-Ibuprofen in plasma|Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.|Pharmacokinetic population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2544285|NCT02963701|Secondary|AUC0-∞ of R-Ibuprofen|This endpoint calculates area under the concentration-time curve of R-Ibuprofen in plasma over the time interval from 0 extrapolated to infinity|Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.|Pharmacokinetic Population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2544286|NCT02963701|Secondary|AUC0-tz of R-Ibuprofen|This endpoint calculates area under the concentration-time curve of R-Ibuprofen in plasma over the time interval from 0 to the time of last quantifiable time point.|Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.|Pharmacokinetic Population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2544287|NCT02963701|Secondary|Area Under the Concentration-time Curve of Pseudoephedrine in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).|This endpoint calculates area under the concentration-time curve of Pseudoephedrine in plasma over the time interval from 0 extrapolated to infinity|Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.|Pharmacokinetic population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2544288|NCT02963701|Secondary|Area Under the Concentration-time Curve of Ibuprofen in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).|This endpoint calculates area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 extrapolated to infinity|Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.|Pharmacokinetic Population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2544289|NCT02963701|Primary|Maximum Concentration of Pseudoephedrine in Plasma (Cmax).|This outcome is maximum measured concentration of the Pseudoephedrine in plasma|Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.|Pharmacokinetic population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2544290|NCT02963701|Primary|Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Pseudoephedrine (AUC0-tz).|This endpoint calculates area under the concentration-time curve of Pseudoephedrine in plasma over the time interval from 0 to the time of last quantifiable time point.|Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.|Pharmacokinetic population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2544291|NCT02963701|Primary|Maximum Concentration of Ibuprofen in Plasma (Cmax).|This outcome is maximum measured concentration of the Ibuprofen in plasma|Samples were collected pre dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.|Pharmacokinetic population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population|||Nano gram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2544292|NCT02963701|Primary|Area Under the Plasma Concentration-time Curve From 0 to Time of Last Quantifiable Time Point (tz) of Ibuprofen. (AUC0-tz)|This endpoint calculates area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 to the time of last quantifiable time point.|Samples were collected Pre-dose and at 0:10, 0:20, 0:30, 0:45, 1:00, 1:15, 1:30, 1:45, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 30:00 hours post dose.|Pharmacokinetic Population (PK Set): All treated subjects that provided observations for both periods for at least one primary endpoint evaluable and without any major protocol deviation thought to interfere with the absorption, distribution, metabolism, and excretion of the compound to be measured were included in the PK population|||Hour nano gram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2544293|NCT02963597|Post-Hoc|Ejection Fraction in HFrEF|Calculated ejection fraction in patients with heart failure with reduced ejection fraction (<45%) at baseline and after 48 hours.|48 hours|Analyzing only patients with heart failure with reduced ejection fraction (<45%).|||percentage (%)||95% Confidence Interval|Mean
2544296|NCT02963597|Secondary|Heart Failure Symptoms|"Heart failure symptoms as assessed by the New York Heart Association scale (NYHA) classification at baseline and after 48 hours. NYHA scale ranges from Class I to IV. Higher classes are associated with worst outcomes.~Class I: No symptoms and no limitation in ordinary physical activity. Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.~Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity.Comfortable only at rest.~Class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients."|48 hours|Data was not available for participants after 48 hours. PI has left the institution; efforts to contact unsuccessful; data information not available for after 48hr time point|||units on a scale||95% Confidence Interval|Mean
2544297|NCT02963597|Secondary|Blood Oxygenation.|Changes in arterial blood oxygenation will be compared via arterial blood gas analysis performed at baseline and after 48h to assess arterial pressure of oxygen.|48 hours|Data was not available for all participants.|||mmHg||95% Confidence Interval|Mean
2544298|NCT02963597|Secondary|Length of Stay|The total stay in the hospital during the admission will be measured by days.|1 year||||days||95% Confidence Interval|Mean
2544299|NCT02963597|Secondary|N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline to 48hrs|To compare changes in N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) measured at baseline and compared to 48hrs after.|48 hours||||picogram/mililiter||95% Confidence Interval|Mean
2544300|NCT02963597|Secondary|Functional Parameters (6 Minute Walk Test) From Baseline to 48hrs|6-minute walk tests were performed on admission and repeated after 48 hours from the initial. The walked distance was measured in meters.|48 hours||||meters||95% Confidence Interval|Mean
2544301|NCT02963597|Primary|Pulmonary Artery Systolic Pressure.|The primary objective of this pilot study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with severe obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters.|48 hours|Patients pulmonary artery systolic pressures were measured by transthoracic echocardiography (TTE) on admission and 48 hours after enrollment.|||mmHg||95% Confidence Interval|Mean
2544302|NCT02962960|Secondary|Number of Participants With Positive Hepatitis B Core Antibody Post-baseline.|Change from screening in Hepatitis B core antibody was monitored during the study for participants tested positive at screening.|Baseline to Week 60|Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). No participants were positive for Hepatitis B at screening, therefore no participants were tested post-baseline.||||||
2544303|NCT02962960|Secondary|Value of Autoantibody Blood Panel Blood Tests to Detect Change From Baseline|Change from baseline in Anti-Double Stranded DNA IgG (anti-dsDNA) is reported.|Baseline to Week 60|Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat). Only participants with abnormal baseline values are included in this analysis.|||IU/mL||Standard Deviation|Mean
2544304|NCT02962960|Secondary|Value of Inflammatory Marker Panel Blood Tests to Detect Change From Baseline|Change from baseline in the Erythrocyte Sedimentation Rate (ESR) inflammatory marker is reported.|Baseline to Week 60|Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).|||mm||Standard Deviation|Mean
2544305|NCT02962960|Secondary|Value of Creatinine Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum)|Change from baseline in clinical creatinine chemistry blood tests (serum) are reported.|Baseline to Week 60|Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).|||umol/L||Standard Deviation|Mean
2544306|NCT02962960|Secondary|Value of Clinical Chemistry Blood Tests to Detect Change From Baseline (Serum)|Change from baseline in clinical chemistry blood tests (Alanine Aminotransferase, Aspartate Aminotransferase) are reported.|Baseline to Week 60|Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).|||ukat/L||Standard Deviation|Mean
2544307|NCT02962960|Secondary|Value of Total Protein Urinalysis Test to Detect Change From Baseline|Change from baseline in total protein urinalysis tests are reported.|Baseline to Week 60|Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).|||g/L||Standard Deviation|Mean
2544308|NCT02962960|Secondary|Value of Protein-creatinine Urinalysis Test to Detect Change From Baseline|Change from baseline in protein-creatinine ratio urinalysis tests are reported.|Baseline to Week 60|Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).|||g/g||Standard Deviation|Mean
2544309|NCT02962960|Secondary|Value of Haematology Blood Tests to Detect Change From Baseline|Change from baseline in haematology blood tests (leucocytes [particle concentration], platelets [particle concentration]) are reported.|Baseline to Week 60|Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).|||10^9/L||Standard Deviation|Mean
2544310|NCT02962960|Secondary|Value of Haemoglobin Blood Test to Detect Change From Baseline|Change from baseline in haemoglobin blood tests are reported.|Baseline to Week 60|Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).|||g/L||Standard Deviation|Mean
2544311|NCT02962960|Secondary|Change From Baseline for 12-lead ECG|The 12-lead ECG measurements were assessed by the investigators, and reported as normal, abnormal (not clinically significant [NCS]), abnormal (clinically significant [CS]), or not done.|Baseline to Week 52|Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).|||Participants|||Count of Participants
2544312|NCT02962960|Secondary|Change From Baseline for Physical Examination|Physical examination is reported as change from baseline in body weight.|Baseline to Week 60|Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).|||kilograms||Standard Deviation|Mean
2544314|NCT02962960|Secondary|Number AEs (Adverse Events) and SAEs (Serious Adverse Events), Including Adverse Events of Special Interest (AESI)|Number of participants with any AEs (Adverse events), any SAEs (serious adverse events), and any adverse events of special interest (AESI) are summarized. More details are reported in the Adverse Events section.|Baseline to Week 52|Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).|||Participants|||Count of Participants
2544315|NCT02962960|Secondary|Number of Participants With Neutralizing Antibodies (nAb)|Incidence of detectable nAb in post-baseline ADA positive participants.|Baseline to Week 52|Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).|||Participants|||Count of Participants
2544316|NCT02962960|Secondary|Number of Participants With Antidrug Antibody (ADA)|Post-baseline ADA incidence based on the number of participants with Antidrug antibody (ADA)|Baseline to Week 52|Includes all participants randomized into the study who receive at least one dose of investigational product, according to randomized treatment (modified Intention-To-Treat).|||Participants|||Count of Participants
2544317|NCT02962960|Primary|21-gene Type 1 IFN Neutralization Ratio (Percent Suppression of Fold Change)|21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. For each individual participant and assessment, the level of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control, as the median of 100-(((baseline-Week 12)/baseline)*100) for the 21 genes. At a population level, the results are presented as mean the above.|Week 12|All participants who are 21-gene IFN test high at baseline.|||percentage neutralization||Standard Deviation|Mean
2544318|NCT02962960|Primary|21-gene Type 1 IFN Signature Score (Fold-change)|21-gene type I IFN signature score (fold change) is based on samples collected both at baseline and Week 12 prior to dosing of study treatment. Levels of 21-gene type I IFN pharmacodynamics signature is derived as relative to a pooled normal control.|Week 12|All participants who are 21-gene IFN test high at baseline.|||fold change||Standard Deviation|Mean
2544319|NCT02962960|Primary|Steady-state Serum Trough (Predose) Concentration (Ctrough) of Anifrolumab|Steady-state serum through concentration (Ctrough) is based on sample collected at Week 12 prior to dosing of study treatment (predose).|Week 12|All participants who received anifrolumab and who had at least one quantifiable serum PK observation post first dose.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2544320|NCT02962960|Primary|Maximum Concentration of Anifrolumab in Serum After First Dose|Maximum concentration (Cmax) of anifrolumab is based on sample collected 5 to 8 days after the first dose of strudy treatment.|Week 0|All participants who received anifrolumab and who had at least one quantifiable serum PK observation post first dose.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2544321|NCT02962934|Primary|Probability of Target Attainment for 40% fT>MIC|The probability of attaining free concentrations above MIC for 40% of the time|24 hour period|For a recommended dose of 1.5g every 8 hours for patients without CRRT and for a dosing regimen of 3g loading dose plus 0.75 g every 8 hours for patients with CRRT when evaluated at the EUCAST MIC breakpoint of 4mg/L for Pseudomonas aeruginosa|||percentage of time above MIC|||Number
2544322|NCT02962908|Other Pre-specified|Duration of Influenza Symptoms in RT-PCR Confirmed Infected Subjects.|Subjects recorded daily influenza symptoms from December 2016 up to March 2017. Subjects with a sudden onset of at least one respiratory and one systemic symptom were swabbed. If the results were positive for influenza then the symptoms were included in the analysis. The duration of symptoms was recorded as the number of symptomatic days during the influenza episode. The following symptoms were recorded: fever (≥38oC), malaise, headache, myalgia (muscle and joint pain), cough, sore throat, shortness of breath, runny nose, stuffy nose, sneezing and earache.|During an influenza episode|FAS population: subjects that completed the vaccination and had immunogenicity data at pre-vaccination and at least one time point post-vaccination.|||days||Standard Error|Mean
2544323|NCT02962908|Other Pre-specified|Severity of Symptoms in RT-PCR Influenza-confirmed Subjects.|Subjects recorded daily influenza symptoms from December 2016 up to March 2017. Subjects with a sudden onset of at least one respiratory and one systemic symptom were swabbed. If the results were positive for influenza then the symptoms were included in the analysis. The duration of symptoms was recorded as the number of symptomatic days during the influenza episode. Fever (≥38oC), malaise, headache, myalgia (muscle and joint pain), cough, sore throat, shortness of breath, runny nose, stuffy nose, sneezing and earache were scored on a severity scale of 0 to 3 (0: no symptom, 1: mild, 2: moderate, 3: severe). The daily severity score was the sum of the severity score for all symptoms listed above on a single day. The total score was the sum of all daily scores during the influenza episode. The peak score was the highest daily score during the influenza episode. The average score was the total score divided by the number of days the influenza episode lasted.|Symptoms experienced during an influenza infection episode, approximately 7-10 days.|FAS: Full Analysis Set includes subjects that completed vaccination and provided samples to assess immunogenicity at pre-vaccination (day 0) and at least one post-vaccination time point (day 42 or day 180).|||units on a scale||Standard Error|Mean
2544324|NCT02962908|Other Pre-specified|Percentage of Participants Who Tested Positive for Influenza Strains|During the influenza season (Dec 2016 to March 2017), fully vaccinated subjects will contact the trial center immediately if they feel unwell for 24h, with a sudden onset of flu-like symptoms. The medical staff will arrange for a nasopharyngeal swab to be performed if the subject has at least one respiratory (cough, sore throat, shortness of breath, runny nose, stuffy nose, sneezing and earache) and one systemic symptom (fever, malaise, headache and myalgia (muscle and joint pain). Swabs should be taken from the reported subjects within 3 days from the trial center being contacted or within 4 days of the onset of symptoms, whatever time is shorter.|For up to 4 months during the influenza season|FAS: Full Analysis Set includes subjects that completed vaccination and provided samples to measure immunogenicity data prevaccination (day 0) and at least one time point post vaccination (day 42 or day 180)|||percentage of subjects|||Number
2544325|NCT02962908|Other Pre-specified|Immune Responses Measured by IFNgamma/Granzyme B ELISPOT|To evaluate the change from baseline in cellular immune responses based on additional CMI assays such as ELISPOT (Enzyme-Linked ImmunoSpot) in all groups at 42 and 180 days following FLU-v vaccination|prevaccination, day 42 (21 days after last vaccination) and day 180.||2019-12-31|12/2019||||
2544327|NCT02962908|Secondary|Antibody Responses to FLU-v|To evaluate the humoral immune responses specific to FLU-v from baseline in all groups 42 and 180 days following FLU-v vaccination. Specific FLU-v IgG antibodies were measured by ELISA. The geometric mean for each treatment group was provided.|prevaccination, day 42 (21 days after last vaccination) and day 180.|FAS: Full Analysis Set includes all subjects that completed the vaccination successfully and provided samples for immunogenicity analysis at baseline (Pre-vaccination) and at least one time point post-vaccination.|||IgG ng/ml||Standard Error|Geometric Mean
2544328|NCT02962908|Secondary|Th2 Cytokine Responses (IL-4)|To evaluate the level of TH2 cytokines (IL-4) from baseline in all groups 42 and 180 days following FLU-v vaccination.|prevaccination, day 42 (21 days after last vaccination) and day 180.|FAS: Full Analysis Set includes all subjects that completed the vaccination successfully and provided samples for immunogenicity analysis at baseline (Pre-vaccination) and at least one time point post-vaccination. Only samples that met the acceptance criteria based on positive and negative controls were used in the analysis|||percentage of responders|||Number
2544329|NCT02962908|Primary|Solicited AEs|To evaluate the solicited AEs in all subjects|until 21 days after the last dosing of the study vaccine|Safety Population: All subjects that received at least one vaccination|||Events|||Number
2544330|NCT02962908|Primary|Percentage of Responders on Day 42 and Day 180 for IFNgamma Secretion by PBMCs|Responders were defined as subjects having at least a two-fold increase in the amount of IFNg secreted on day 42 and day 180 compared the amount secreted on day 0. IFNg was measured by ELISA|prevaccination (day 0) to postvaccination (day 42 and day 180)|FAS: Full Analysis Set including subjects that completed vaccination and provided immunogenicity samples for prevaccination and at least one post-vaccination time point (day 42 or day 180). Only samples that meet the acceptance criteria based on the positive and negative controls were used in the analysis.|||percentage responders|||Number
2544331|NCT02962908|Primary|Percentage of CD4+ TH1 Cytokine Responders|To compare the number of subjects that showed at least a two-fold increase on day 42 and day 180 following vaccination in the number of CD4+T-cells secreting TH1 cytokines in all groups.|prevaccination, day 42 (21 days after last vaccination) and day 180.|FAS population: Full Analysis Set corresponds to subjects that completed the vaccination successfully and provided samples for immunogenicity analysis for baseline (pre-vaccination) and at least one time point post-vaccination. Only samples with acceptable positive and negative controls were used in the analysis.|||percentage of responders|||Number
2544332|NCT02962882|Secondary|Wear Time (Days) for First Dressing|Maximum length of wear time/stay on ability of dressings in ICU.|4-6 days|ITT population|||Participants|||Count of Participants
2544333|NCT02962882|Primary|User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication|"User friendliness judged by site staff, with the following variables; How do you prefer this dressing to your current dressing?~*NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits.~Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections)."|4-6 days|ITT population As a dressing change was not required at all visits, the total number of dressing changes will vary for each variable and a question was perhaps not relevant at a given visit (some questions were only relevant for dressing applications, some were only relevant for dressing removals or only relevant for dressing inspections).|||Number of dressing changes|Number of dressing changes||Count of Units
2544334|NCT02962882|Primary|User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication|"User friendliness judged by site staff, with the following variables; Ability to stay in place Facilitation of inspection Ease of reapplication Conformability to the body Overall impression of dressing~*NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits.~Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections)."|4-6 days|ITT population As a dressing change was not required at all visits, the total number of dressing changes evaluated vary for each variable and a question was perhaps not relevant at a given visit (some questions were only relevant for dressing applications, some were only relevant for dressing removals or only relevant for dressing inspections).|||Dressing changes evaluated|Dressing changes evaluated||Count of Units
2544335|NCT02962687|Other Pre-specified|Anxiety|Descriptive analysis of anxiety as measured by the Generalized Anxiety Disorder Scale (GAD-7; range 0 - 21; lower scores are better)|14 weeks|The GAD-7 was administered to the Veteran participants only.|||score on a scale||Standard Deviation|Mean
2544336|NCT02962687|Other Pre-specified|Social Support|Descriptive analysis of social support as measured by modified Medical Outcomes Study Social Support Survey (mMOS-SS; range 0 - 100; higher scores are better)|14 weeks|The mMOS-SS was administered to the Veteran participants only.|||score on a scale||Standard Deviation|Mean
2544337|NCT02962687|Other Pre-specified|Depression|Descriptive analysis of depression as measured by Patient Health Questionnaire-Depression (PHQ-9; range 0 - 27; lower scores are better)|14 weeks|The PHQ-9 was administered to the Veteran participants only.|||score on a scale||Standard Deviation|Mean
2544338|NCT02962687|Other Pre-specified|Quality of Life Outcome|Descriptive analysis of health-related quality of life as measured by 3 subscales of the Patient Reported Outcomes Measurement Information System (PROMIS-29; range 4 - 20 for each; lower scores are better)|14 weeks|The PROMIS subscales were administered to the Veteran participants only.|||score on a scale||Standard Deviation|Mean
2544341|NCT02962687|Primary|Usability of Video-Enhanced Care Management for Medically Complex Veterans With CI|Usability of the video-enhanced care management program will be examined using the System Usability Scale (SUS; range 0 - 100; higher scores are better).|14 weeks|The System Usability Scale was administered only to the videoconference care management Veteran participants.|||score on a scale||Standard Deviation|Mean
2544342|NCT02962687|Primary|Number of Scheduled Intervention Phone or Video Calls Completed by Participants|Feasibility will be assessed by examining rates of adherence to intervention phone/video calls.|14 weeks|These number represent the Veterans in the sample (Care Partners not analyzed)|||calls|calls||Count of Units
2544343|NCT02962687|Primary|Number of Participants Reporting That They Would Be Likely to See a Healthcare Provider Using Videochat|Acceptability will be assessed using the measure of likelihood of seeing a healthcare provider using videochat.|14 weeks|These numbers represent the Veterans in the sample (Care Partners not analyzed)|||Participants|||Count of Participants
2544344|NCT02962648|Secondary|Change in S-iron From Baseline to Week 2, 13, and 26|"Efficacy.~Change in s-iron from baseline to week 2, 13, and 26."|Baseline, week 2, 13, and 26|Intention-to-treat (ITT) analysis set: included all subjects, except for screening failures and subjects withdrawn before visit 2 (baseline).|||μg/dL||Standard Deviation|Mean
2544345|NCT02962648|Secondary|Change in Transferrin Saturation (TSAT) From Baseline to Week 2, 13, and 26|"Efficacy~Change in transferrin saturation (TSAT) from baseline to week 2, 13, and 26.~TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron."|Baseline, week 2, 13, and 26|Intention-to-treat (ITT) analysis set: included all subjects, except for screening failures and subjects withdrawn before visit 2 (baseline).|||percentage of saturation||Standard Deviation|Mean
2544346|NCT02962648|Secondary|Change in S-ferritin From Baseline to Week 2, 13, and 26|"Efficacy.~Change in s-ferritin from baseline to week 2, 13, and 26."|Baseline, week 2, 13, and 26|Intention-to-treat (ITT) analysis set: included all subjects, except for screening failures and subjects withdrawn before visit 2 (baseline).|||ng/mL||Standard Deviation|Mean
2544347|NCT02962648|Secondary|Change in Hb From Baseline to Week 2, 13, and 26|"Efficacy.~Change in Hb from baseline to week 2, 13, and 26."|Baseline, week 2, 13, and 26|Intention-to-treat (ITT) analysis set: included all subjects, except for screening failures and subjects withdrawn before visit 2 (baseline).|||g/dL||Standard Deviation|Mean
2544348|NCT02962648|Secondary|S-phosphate <2 mg/dL at Any Time From Baseline to Week 26|"Safety~Results show the number of trial participants and their status of s-phosphate <2 mg/dL, at any time from baseline to week 26."|Baseline to week 26|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||Participants|||Count of Participants
2544349|NCT02962648|Secondary|Time to First Composite Cardiovascular Safety AE|"Safety~Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit. Only the adjudicated and confirmed composite cardiovascular safety AEs, as judged by the Clinical Endpoint Adjudication Committee (CEAC), were considered for this endpoint.~Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit."|Baseline, week 2, 13, and 26|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||week||95% Confidence Interval|Median
2544350|NCT02962648|Secondary|Composite Cardiovascular Adverse Events (AEs)|"Safety~Results show the composite cardiovascular AEs, that started on or after the first dose of treatment (i.e. treatment emergent) up to month 6.~The reported potential cardiovascular AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).~The potential cardiovascular AEs included the following:~Death due to any cause~Non-fatal myocardial infarction~Non-fatal stroke~Unstable angina requiring hospitalisation~Congestive heart failure requiring hospitalisation or medical intervention~Arrhythmias~Hypertension~Hypotension~Results show only those participants that had adjudicated and confirmed treatment-emergent composite cardiovascular AEs."|Baseline to week 26|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||Participants|||Count of Participants
2544351|NCT02962648|Secondary|Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions|"Safety.~For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity terms that were included in the analysis were those that started or after the first dose of treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: Loss of consciousness; Seizure; Syncope; Unresponsiveness.~The potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).~Results show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions."|Baseline to week 26|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||Participants|||Count of Participants
2544352|NCT02962648|Primary|Number of Subjects With Adverse Drug Reactions (ADR)|"Safety~Evaluate the number of subjects with adverse drug reactions (ADRs), defined as AEs that were assessed by the investigator as related or possible related to the investigational product."|Baseline to week 26|Safety analysis set: included all subjects who received at least one dose of the investigational product.|||Participants|||Count of Participants
2544353|NCT02962609|Other Pre-specified|Feeding Performances|Feeding duration (minute)|during feeding (maximum 30 min)||||minutes||Standard Deviation|Mean
2544354|NCT02962609|Secondary|Heart Rate/Minute During Feeding|Heart rate were measured by using a pulse oximeter 2 min before the feeding, during the feeding and for 30 min after the feeding. Feeding duration, feeding efficiency, and percentage of food intake were evaluated via a video during the feeding and recorded after the feeding.|During feeding (maximum 30 min)||||Beats per min||Standard Deviation|Mean
2544355|NCT02962609|Primary|Percentage of Oxygen Saturation|Oxygen saturation were measured by using a pulse oximeter 2 min before the feeding, during the feeding and for 30 min after the feeding.|During feeding (maximum 30 min)||||SpO2%||Standard Deviation|Mean
2544356|NCT02962427|Primary|Change in The Numerical Rating Scale Pain Score|The Numerical Rating Scale (NRS) is commonly used to evaluate pain level in patients. It is presented as a numerical scale of 11 options, numbered 0-10, where the patient's pain intensity is represented by a number between the extremes of 0 = no pain at all to 10 = worst pain imaginable in numerical fashion. Its simplicity, reliability, and validity have made the NRS a useful tool for describing pain severity or intensity. The Investigators will consider a difference of 20% as a clinically significant change in pain score.|Baseline and 48 hours|Some subjects refused to give a 48 hour score.|||score on a scale|||Number
2544357|NCT02962284|Secondary|Percentage of Subjects With Prostate Specific Antigen - 50 Response|A decrease of ≥50% reduction from baseline of the study CHL-AA-201|360 days||||percentage of number of subjects|||Number
2544358|NCT02962284|Secondary|Testosterone Complete Suppression|Proportion of subjects with complete suppression of testosterone levels|360 days||||percentage of subjects|||Number
2544359|NCT02962284|Secondary|Prostate Specific Antigen Levels|Change in serum testosterone levels after one year of treatment against baseline|One year||||ng/dL||Standard Deviation|Mean
2544360|NCT02962284|Secondary|Testosterone Levels|Change in serum testosterone levels from baseline|Baseline and 360 days||||ng/dL||Standard Deviation|Mean
2544361|NCT02962284|Secondary|Proportion of Subjects With Disease Progression|Number of participants who had disease progression|one year||||Participants|||Count of Participants
2544362|NCT02962284|Primary|Number of Subjects With Adverse Events|Adverse events|one year|subjects who were enrolled and who received at least 1 dose of study drug of Yonsa|||Participants|||Number
2544363|NCT02961946|Primary|Coronary Artery Diameter Change|Average diameter of coronary arteries at 7 predefined locations in the proximal, mid, and distal segments of the left main, left anterior descending, left circumflex and right coronary artery. Measurements avoid areas of coronary non-calcified and calcified plaques and measured twice for each location. Proximal and distal deviation from original measurements is possible in case of plaque.|obtained on the same day (day 0) of nitroglycerine administration (nitroglycerine is administered during the cCTA exam appointment).||||Fold change||95% Confidence Interval|Mean
2544364|NCT02961920|Primary|PaO2(Partial Pressure of Oxygen in Arterial Blood)|ten minutes after tracheal intubation to 90 min after prone position|ten minutes after tracheal intubation to 90 min after prone position||||mmHg||Standard Deviation|Mean
2544365|NCT02961790|Secondary|Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)|"The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below."|Up to 7 weeks|Patients who received at least one cycle of treatment and were assessed for adverse events were included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose and high-dose oxybutynin chloride groups.|||Participants|||Count of Participants
2544366|NCT02961790|Secondary|Average Change of Daily Interference (Work) From Baseline to Week 7 as Measured by the Hot Flash-Related Daily Interference Scale (HFRDIS) Comparing Low Dose Oxybutynin vs Placebo and High Dose Oxybutynin vs Placebo|"Average Change of daily interference (Work) from baseline to Week 7 as measured by the Hot Flash-Related Daily Interference Scale (HFRDIS) comparing Low dose oxybutynin vs Placebo and High dose oxybutynin vs Placebo. HFRDIS Work item (Work (work outside the home and housework)) Interference scores run from 0 to 10 with 0 being no interference and 10 being complete interference."|Baseline up to day 49|Patients who completed the Hot Flash-Related Daily Interference Scale (HFRDIS) Work item at baseline and week 7 are included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose and high-dose oxybutynin chloride groups.|||change in score on a scale||Standard Deviation|Mean
2544367|NCT02961790|Secondary|Average Change of Severity of Stomach Pain/Cramps Symptoms as Measured by the Symptom Experience Questionnaire From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo|"Average Change of severity of Stomach pain/cramps symptoms as measured by the Symptom Experience Questionnaire From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo The Symptom Experience Questionnaire stomach pain/cramps item (Over the past week, have you experienced stomach pain or cramps?) is scored from 0 to 10 with higher values being worse symptoms. So a negative value means the symptom is improving and a positive score means the symptom is getting worse."|Baseline up to day 49|Patients who completed baseline and week 7 Symptom Experience Questionnaire Stomach pain/cramps item were included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose and high-dose oxybutynin chloride groups.|||change in score on a scale||Standard Deviation|Mean
2544368|NCT02961790|Secondary|Average Change in Hot Flash Score From Week 1 to Week 7 Comparing High Dose Oxybutynin to Placebo|Average change in Hot Flash Score from Week 1 to Week 7 Comparing High Dose Oxybutynin to Placebo. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included low dose oxybutynin, weeks 1-7, no current aromatase inhibitor, age group 18-49, no tamoxifen, hot flash symptom duration < 9 months, and 4-9 hot flashes/day as fixed effects, and participant and error as random effects. The mean change in Hot Flash Score from Week 1 to Week 7 is reported below for the high-dose oxybutynin and placebo groups.|Baseline up to day 49|Patients who received higher dose oxybutynin or placebo and completed the Hot Flash Diary at baseline and Week 7 are included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the high-dose oxybutynin chloride group.|||score on a scale||Standard Error|Least Squares Mean
2544380|NCT02961764|Secondary|Patient Satisfaction With Care: Satisfaction With the Average Time to Administer Each IV|Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.|Day 14|119 & 124 patients provided any survey data in the usual care group & new critical pathway group; 87 & 119 patients received IV antibiotic therapy in the usual care group & new critical pathway group; 85 and 118 patients answered this question in the usual care group & new critical pathway group, respectively.|||Scores on a Scale||Standard Deviation|Mean
2544369|NCT02961790|Secondary|Average Change in Hot Flash Score From Week 1 to Week 7 Comparing Low Dose Oxybutynin to Placebo|Average change in Hot Flash Score from Week 1 to Week 7 Comparing Low Dose Oxybutynin to Placebo. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included low dose oxybutynin, weeks 1-7, no current aromatase inhibitor, age group 18-49, no tamoxifen, hot flash symptom duration < 9 months, and 4-9 hot flashes/day as fixed effects, and participant and error as random effects. The mean change in Hot Flash Score from Week 1 to Week 7 is reported below for the low-dose oxybutynin and placebo groups.|Baseline up to day 49|Patients who received low-dose oxybutynin or placebo and completed the Hot Flash Diary at baseline and Week 7 are included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose oxybutynin chloride group.|||score on a scale||Standard Error|Least Squares Mean
2544370|NCT02961790|Primary|Average Change in Hot Flash Activity Score From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo|Average change in hot flash activity score from baseline to Week 7 for Low Dose Oxybutynin vs Placebo. The hot flash activity will be measured by the weekly average hot flash score (Sloan JA, et. al., 2001), which is a composite entity of both frequency and severity of hot flashes (The Hot Flash Diary collects the following information for Day 1- Day 7 of each week: Number of mild hot flashes, Number of moderate hot flashes, Number of severe hot flashes, Number of very severe hot flashes). This is a count, so it can range from 0 to infinity.|Baseline up to day 49|Patients who received high-dose oxybutynin, low-dose oxybutynin or placebo and completed the Hot Flash Diary at baseline and Week 7 are included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose and high-dose oxybutynin chloride groups.|||score on a scale||Standard Deviation|Mean
2544371|NCT02961764|Secondary|Patient Health-related Quality of Life (HRQoL) Assessed by the Short Form 12 (SF-12) 12-Item Patient Questionnaire|The SF-12 yields a physical and a mental health component summary score (referred to as physical component summary score [PCS] and mental component summary score [MCS]). The PCS and MCS follow a t-score distribution, i.e. mean of 50 and standard deviation of 10 in the general US population, meaning all scores above or below 50 are above and below the average, respectively, in the US general population.|Day 14|FAS population. 119 and 122 patients provided any and all survey data in the usual care group and the new critical pathway group, respectively.|||Score on a Scale||Standard Deviation|Mean
2544372|NCT02961764|Secondary|Patient Work and Productivity Loss as Assessed Through the Work Productivity and Activity Impairment Questionnaire|Number of days with lost/reduced productivity during follow-up, as measured with Work Productivity and Activity Impairment (WPAI) Questionnaire|Day 14|FAS population. 119 and 123 patients provided any survey data in the usual care group and the new critical pathway group; 53 and 48 patients completed all survey questions in the usual care group and new critical pathway group, respectively. 61 and 56 were employed.|||Percentage||Standard Deviation|Mean
2544373|NCT02961764|Secondary|Patient Satisfaction With Care: Find Value in a Physician|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|Day 14|FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group; 115 and 123 patients answered this survey question in the usual care group & new critical pathway group, respectively.|||Participants|||Count of Participants
2544374|NCT02961764|Secondary|Patient Satisfaction With Care: Time Willing to Spend Receiving Each IV|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|Day 14|FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group; 117 and 123 patients answered this survey question in the usual care group & new critical pathway group, respectively.|||Participants|||Count of Participants
2544375|NCT02961764|Secondary|Patient Satisfaction With Care: Regimen Preferred if Treated Again for a Similar Skin Infection With IV|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|Day 14|FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group; 117 and 121 patients answered this survey question in the usual care group & new critical pathway group, respectively.|||Participants|||Count of Participants
2544376|NCT02961764|Secondary|Patient Satisfaction With Care: Factors Contributing to Preference for Outpatient Care|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|14 Days|FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively. Patients may have checked multiple responses.|||Participants|||Number
2544377|NCT02961764|Secondary|Patient Satisfaction With Care: Healthcare Setting Preferred if Treated Again for a Skin Infection With IV|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|14 Days|FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group; 116 and 123 patients answered this question in the usual care group & new critical pathway group, respectively.|||Participants|||Count of Participants
2544378|NCT02961764|Secondary|Patient Satisfaction With Care: Average Time to be Seen by a Healthcare Provider|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|14 days|119 & 124 patients provided any survey data in the usual care group & new critical pathway group; 87 & 119 patients received IV antibiotic therapy in the usual care group & new critical pathway group; 86 and 118 patients answered this question in the usual care group & new critical pathway group, respectively.|||Participants|||Count of Participants
2544379|NCT02961764|Secondary|Patient Satisfaction With Care: Time to Travel to Appointments to Receive IV|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|14 days|119 & 124 patients provided any survey data in the usual care group & new critical pathway group; 87 & 119 patients received IV antibiotic therapy in the usual care group & new critical pathway group; 86 and 118 patients answered this question in the usual care group & new critical pathway group, respectively.|||Participants|||Count of Participants
2544396|NCT02961764|Secondary|Number of Participants With Infection-related Outpatient Healthcare Visits||44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.|||Participants|||Number
2544381|NCT02961764|Secondary|Patient Satisfaction With Care: Satisfied With the Number of IV Infusions Received Per Day|Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.|Day 14|119 & 124 patients provided any survey data in the usual care group & new critical pathway group; 87 & 119 patients received IV antibiotic therapy in the usual care group & new critical pathway group; 85 and 118 patients answered this question in the usual care group & new critical pathway group, respectively|||Scores on a scale||Standard Deviation|Mean
2544382|NCT02961764|Secondary|Patient Satisfaction With Care: Concerned About Receiving Your IV Therapy|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|Day 14|119 & 124 patients provided any survey data in the usual care group & new critical pathway group; 87 & 119 patients received IV antibiotic therapy in the usual care group & new critical pathway group; 87 and 118 patients answered this question in the usual care group & new critical pathway group, respectively.|||Participants|||Count of Participants
2544383|NCT02961764|Secondary|Patient Satisfaction With Care: IV Therapy Hindering Normal Activities of Daily Living|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|Day 14|119 & 124 patients provided any survey data in the usual care group & new critical pathway group; 87 & 119 patients received IV antibiotic therapy in the usual care group & new critical pathway group; 87 and 118 patients answered this question in the usual care group & new critical pathway group, respectively|||Participants|||Count of Participants
2544384|NCT02961764|Secondary|Patient Satisfaction With Care: Factors Contributing to Dissatisfaction With Receiving IV|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|14 Days|FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively. Patients may have checked multiple responses.|||Participants|||Number
2544385|NCT02961764|Secondary|Patient Satisfaction With Care: Factors Contributing to Satisfaction With Receiving IV|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|Day 14|FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively. Patients may have checked multiple responses.|||Participants|||Number
2544386|NCT02961764|Secondary|Patient Satisfaction With Care: Satisfaction With Receiving IV Antibiotic Therapy|Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.|Day 14|119 & 124 patients provided any survey data in the usual care group & new critical pathway group; 87 & 119 patients received IV antibiotic therapy in the usual care group & new critical pathway group; 86 and 119 patients answered this question in the usual care group & new critical pathway group, respectively.|||Scores on a Scale||Standard Deviation|Mean
2544387|NCT02961764|Secondary|Patient Satisfaction With Care: Received IV Antibiotic Therapy for Skin Infections|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|Day 14|FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively.|||Participants|||Count of Participants
2544388|NCT02961764|Secondary|Patient Satisfaction With Care: Factors for Dissatisfaction With Your Hospital Stay|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|Day 14|FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively. Patients may have checked multiple responses.|||Participant|||Number
2544389|NCT02961764|Secondary|Patient Satisfaction With Care: Satisfaction With Hospital Stay|Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.|Day 14|FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively. 63 and 27 patients had a hospital stay in the usual care group and new critical pathway group, respectively.|||Scores on a Scale||Standard Deviation|Mean
2544390|NCT02961764|Secondary|Patient Satisfaction With Care: Hospitalization|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|Day 14|FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively.|||Participants|||Count of Participants
2544391|NCT02961764|Secondary|Patient Satisfaction With Care: Wait in Emergency Room|Patients rated their satisfaction on a 10-point scale, where 0 was the worst experience possible and 10 the best experience possible.|Day 14|FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively.|||scores on a scale||Standard Deviation|Mean
2544392|NCT02961764|Secondary|Patient Satisfaction With Care: Overall Health|Patient satisfaction with care as assessed through the ABSSSI Patient Satisfaction Survey (patient reported).|Day 14|FAS population. 119 and 124 patients provided any survey data in the usual care group and the new critical pathway group, respectively.|||Participants|||Count of Participants
2544393|NCT02961764|Secondary|Number of Participants With Serious Adverse Events (SAEs)||44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion|||Participants|||Count of Participants
2544394|NCT02961764|Secondary|Number of Participants With Infection-related Healthcare Visits Due to PICC Line or Central Line Used to Administer Antibiotic Therapy||44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.|||Participants|||Count of Participants
2544395|NCT02961764|Secondary|Use of a Peripherally-Inserted Central Catheter (PICC) Line or Central Line to Administer Antibiotic Therapy||44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.|||Participants|||Number
2544476|NCT02959996|Secondary|Satisfaction With Post-operative Pain Control|PAIN OUT Tool, 0-10 scale, where 0 is not satisfied and 10 is satisfied|48-hours post-operatively||||units on a scale||Inter-Quartile Range|Median
2544397|NCT02961764|Secondary|Number of Participants With Infection-related Emergency Department (ED) Visits||44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.|||Participants|||Number
2544398|NCT02961764|Secondary|Number of Participants With All Cause Hospitalizations in the 30 Days Post Discharge From the Hospital or Release From the ED||Follow-up: 30 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.|||Participants|||Number
2544399|NCT02961764|Secondary|Number of Participants With Infection-related Hospitalizations During Initial Care and Follow-up That Resulted in Admission to Intensive Care Unit||44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.|||Participants|||Count of Participants
2544400|NCT02961764|Secondary|Number of Participants With Infection-related Hospitalizations|Number of days of hospitalization during the initial hospitalization (for those initially hospitalized) and all other infection-related hospitalizations|44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.|||Participants|||Count of Participants
2544401|NCT02961764|Secondary|Number of Infection-related Total Admitted Hospital Days||44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.|||Days||Standard Deviation|Mean
2544402|NCT02961764|Secondary|Number of Participants With Infection-related Major Surgical Interventions That Required Operating Room Time|Number of all major surgical interventions unexpected or expected that required operating room time|44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.|||Participants|||Count of Participants
2544403|NCT02961764|Secondary|Total Length of Stay in Emergency Department (ED) During the Initial Episode of Care|Time spent in ED in hours from triage to release (either admitted to the hospital, admitted to observation, or released to home)|Initial Care: 14 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.|||Hours||Standard Deviation|Mean
2544404|NCT02961764|Secondary|Number of Total Admitted Hospital Days|Number of days during the initial hospitalization (for those initially hospitalized) and all other hospitalizations|44 Days|FAS population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion. Patients who discontinued prior to day 14 of the study were excluded from the Follow-up and Entire Study Duration analyses due to missing data for 15-44 day period.|||Days||Standard Deviation|Mean
2544405|NCT02961764|Primary|Hospital Admission Rate at Initial Episode of Care||44 Days|Full analysis set (FAS) population consists of all enrolled patients that has received at least one dose of antibiotics or one dose of dalbavancin for inclusion.|||Participants|||Count of Participants
2544406|NCT02961751|Secondary|The Number of Subjects With Pharyngeal Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae|Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each pharyngeal sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was < 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.|Day 1|Analysis population was intention-to-treat.|||Participants|||Count of Participants
2544407|NCT02961751|Secondary|The Number of Subjects With Rectal Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae|Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each rectal sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was < 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.|Day 1|Analysis population was intention-to-treat.|||Participants|||Count of Participants
2544408|NCT02961751|Secondary|The Number of Subjects With Cervical Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae|Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each cervical sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was < 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.|Day 1|Analysis population was intention-to-treat.|||Participants|||Count of Participants
2544409|NCT02961751|Secondary|The Number of Subjects With Urethral Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae|Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each urethral sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was < 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.|Day 1|Analysis population was intention-to-treat.|||Participants|||Count of Participants
2544410|NCT02961751|Secondary|The Percentage of Microbiologically Cured Subjects Who Had Throat Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae|Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) at the throat were evaluated for microbiological cure at 5-10 days after treatment. Cure was defined as N. gonorrhoeae not detectable by culture from all anatomical sites that had detectable N. gonorrhoeae at baseline|Day 5 through Day 10|The per protocol population was limited to subjects meeting all inclusion criteria and no exclusion criteria and who were positive for wild type N. gonorrhoeae of the throat at baseline.|||percentage of subjects||95% Confidence Interval|Number
2544411|NCT02961751|Secondary|The Percentage of Microbiologically Cured Subjects Who Had Rectal Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae|Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) at the rectum were evaluated for microbiological cure at 5-10 days after treatment. Cure was defined as N. gonorrhoeae not detectable by culture from all anatomical sites that had detectable N. gonorrhoeae at baseline|Day 5 through Day 10|The per protocol population was limited to subjects meeting all inclusion criteria and no exclusion criteria and who were positive for rectal wild type N. gonorrhoeae at baseline.|||percentage of subjects||95% Confidence Interval|Number
2544412|NCT02961751|Secondary|The Percentage of Microbiologically Cured Subjects Who Had Urogenital Tract Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae|Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) at the urogenital tract were evaluated for microbiological cure at 5-10 days after treatment. Cure was defined as N. gonorrhoeae not detectable by culture from all anatomical sites that had detectable N. gonorrhoeae at baseline|Day 5 through Day 10|The per protocol population was limited to subjects meeting all inclusion criteria and no exclusion criteria and who were positive for urogenital wild type N. gonorrhoeae at baseline.|||percentage of subjects||95% Confidence Interval|Number
2544413|NCT02961751|Primary|The Percentage of Subjects Infected With Gyrase A (gyrA) Serine 91 Genotype of Neisseria Gonorrhoeae (N. Gonorrhoeae) With Microbiological Cure|Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) were evaluated for microbiological cure at 5-10 days after treatment. Cure was defined as N. gonorrhoeae not detectable by culture from all anatomical sites that had detectable N. gonorrhoeae at baseline.|Day 5 through Day 10|The per protocol population was limited to subjects meeting all inclusion criteria and no exclusion criteria and who were positive for rectal/urogenital wild type N. gonorrhoeae at baseline.|||percentage of subjects||95% Confidence Interval|Number
2544414|NCT02961244|Secondary|Maintaining Normothermia Rate|"Within the surgery day, from patient bed through the operating room to PACU or ICU or back to patient bed.~With these results our intervention group's maintaining normothermia rates were higher respectively. ( p=0.001) For each patients around 11 temperature measurement had been made according to the operation time . If any measurement of any patients was <36 ºC , that patient accepted as hypothermic. (Failure to maintain normothermia)"|Surgery day|Patients and their results assessed on the basis of intention to treat per protocole.|||Participants|||Count of Participants
2544415|NCT02961244|Primary|Surgical Site Infection Rate|"Within the postoperative 30 days, if there is purulent exudate or nonpurulent but culture was pozitive, we accepted them as Surgical Site Infection (SSI) diagnosed.~All patients were made enough incision wide to explore their entire abdomen defined as Major Abdominal Surgery .~With this results between two groups intervention group had lesser rates of SSI respectively( (p=0.045 Mann Whitney U, n<30), (p=0.044 chi-square )"|Postoperative 30 days|Patients and their results assessed on the basis of intention to treat per protocole.|||Participants|||Count of Participants
2544416|NCT02961062|Secondary|Plasma Concentration of SAF312|C Max|day1, day 4|PK Analysis set|||ng/mL||Standard Deviation|Mean
2544417|NCT02961062|Secondary|VAS Pain Assessments|VAS pain assessment during the first 72 hours post-operatively. VAS pain severity scale from the first post-operative assessment to pre-dose 12 hours post-operative assesment The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain|72 hours|Primary PD Analysis set|||score on a scale||Standard Error|Mean
2544418|NCT02961062|Secondary|Incidence of and Amount of Rescue Oral Analgesics (Number of Participants Who Did Not Use Oral Rescue Medication)|Summary of oral rescue medication use incidence (number of patients who DID NOT use oral rescue medication)|6,12, 24, 48 and 72 hours post-operatievly|Secondary PD analysis set|||Participants|||Count of Participants
2544419|NCT02961062|Primary|Average Ocular Pain VAS Assessments|VAS pain severity scale from the first post-operative assessment to pre-dose 12 hours post-operative assesment The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain|12 hours|Primary PD Analysis set|||score on a scale||Standard Error|Mean
2544420|NCT02961062|Primary|Visual Analog Scale (VAS) Pre-dose Pain Assessment|VAS pain severity scale pre-dose, 6 hours post-operatively. The Visual Analog Scale (VAS) is a commonly used measurement of pain, discomfort, that goes from 0 meaning no pain to 100 meaning worst imaginable pain|6 hours|Primary PD Analysis set|||score on a scale||Standard Error|Mean
2544421|NCT02960997|Secondary|Change in mTOR Pathway Inhibition|Molecular biology study of skin biopsies assayed for mTOR pathway inhibition (e.g. determination of phosphoprotein inhibition included ribosomal protein S6, S6 kinase and/or eIF-4E binding protein).|Baseline, week 12|Data were not collected for this outcome measure||||||
2544422|NCT02960997|Secondary|Foot Plantar Pressure Measurements|Foot plantar pressure measurements before and after treatment using the Podotech Elftman Foot Scanner.|Baseline, week 12|Data were not collected for this outcome measure.||||||
2544423|NCT02960997|Secondary|Plantar Defect Size Using 3D Photography|Plantar defect size measurements using 3D photography (% change in total defect area).|Baseline, week 12|Data were not collected for this outcome measure.||||||
2544424|NCT02960997|Secondary|5-D Pruritus Scale Score|The 5-D Pruritus Scale is a 1-page, 5-question tool used in clinical trials to assess 5 dimensions of background itch: degree, duration, direction, disability, and distribution. Each question corresponds to 1 of the 5 dimensions of itch; participants were to rate their symptoms over the preceding 2-week period on a 1 to 5 scale, with 5 being the most affected. After the summation of individual score, the total score ranges from 5 (least affected) to 25 (most affected). Data are reported per intervention.|Week 0 and week 12 of the respective treatment period||||score on a scale||Standard Deviation|Mean
2544425|NCT02960997|Secondary|Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI) Disease Severity Scale Score|The EBDASI is a validated scoring system that objectively quantifies the severity of EB affecting the entire body. It has been designed to evaluate the response to new therapies for the treatment of EB. Scores range from 0 (absent of EB) to 10 (entire area involved). Data are reported per intervention.|Week 0 and week 12 of the respective treatment period||||score on a scale||Standard Deviation|Mean
2544426|NCT02960997|Secondary|Child Dermatological Quality of Life Questionnaire Score|Quality of Life-Epidermolysis Bullosa (QOLEB) Questionnaire specifically designed for people with EB. The QOLEB can be used to identify everyday life occurrences negatively affected by EB. It assesses change in quality of life over time, an important measure when assessing the success of new treatments for EB. Scores from 0 to 51, with higher scores indicate greater impact of EB on quality of life. Data are reported per intervention.|Week 0 and week 12 of the respective treatment period||||score on a scale||Standard Deviation|Mean
2544427|NCT02960997|Secondary|Average Steps Per Day Assessed by FitBit® / Pedometer|Average number of steps walked per day from baseline to the end of each treatment.|12 weeks|One participant had no Fitbit data during placebo treatment and is excluded from the analysis. Three participants lost their Fitbit devices for week 12 reporting during sirolimus treatment; their data through week 8 are included in the analysis.|||steps||Standard Deviation|Mean
2544428|NCT02960997|Primary|Trough Concentration of Sirolimus|Trough measurements were taken prior to topical sirolimus administration at the week 12 study visit.|Week 12|Trough concentration of sirolimus was collected during Sirolimus treatment only, so the Placebo group is not presented in this outcome measure.|||ng/mL||Standard Deviation|Mean
2544429|NCT02960997|Primary|Foot Health Status Questionnaire, Physical Activity Domain Score|Physical Activity was assessed utilizing the validated Foot Health Status Questionnaire (FHSQ). Low Score (0) means severely limited in performing a broad range of physical activities. High Score (100) means can perform all desired physical activities. Data are reported per intervention.|Week 0 and week 12 of the respective treatment period||||score on a scale||Standard Deviation|Mean
2544430|NCT02960997|Primary|Foot Health Status Questionnaire, Foot Function Domain Score|Foot function was assessed utilizing the validated Foot Health Status Questionnaire (FHSQ). Low Score (0) means severely limited in performing a broad range of physical activities. High Score (100) means can perform all desired physical activities. Data are reported per intervention.|Week 0 and week 12 of the respective treatment period||||score on a scale||Standard Deviation|Mean
2544431|NCT02960854|Secondary|Number of Participants With Any Detectable Anti-drug Antibodies||Baseline and subsequent days after, up to 90 days|All Treated Participants|||Percentage|||Number
2544432|NCT02960854|Secondary|Number of Participants With Detectable Anti-nivolumab Antibodies|Participant with positive anti-drug antibody detection|Baseline and subsequent days after, up to 90 days|All Treated Participants|||Percentage|||Number
2544433|NCT02960854|Secondary|Receptor Occupancy|Receptor occupancy on T cells at baseline and after study treatment administration at planned sampling time points|Day 1 and up to day 90 (discharge)|All Treated Participants|||Percentage||Standard Deviation|Mean
2544434|NCT02960854|Primary|Half-life (T1/2)|Half-Life of nivolumab derived from serum concentration|Day 1 and subsequent days after, up to 90 days|All Treated Participants|||hours||Standard Deviation|Mean
2544435|NCT02960854|Primary|Volume of Distribution (Vd)|Vlume of distribution of nivolumab serum concentration|Day 1 and subsequent days after, up to 90 days|All Treated Participants|||L||Geometric Coefficient of Variation|Geometric Mean
2544436|NCT02960854|Primary|Total Clearance (CLT)|Total clearance of serum concentration of nivolumab|Day 1 and subsequent days after, up to 90 days|All Treated Participants|||L/h||Geometric Coefficient of Variation|Geometric Mean
2544437|NCT02960854|Primary|Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]|Area under the serum concentration-time curve from time zero to time of last quantifiable concentration|Day 1 and subsequent days after, up to 90 days|All Treated Participants|||h*ug/mL||Geometric Coefficient of Variation|Geometric Mean
2544438|NCT02960854|Primary|Time of Maximum Observed Concentration (Tmax)|Participant observed time of maximum concentration|Day 1 and subsequent days after, up to 90 days|All Treated participants|||hours||Full Range|Median
2544439|NCT02960854|Primary|Average Nivolumab Serum Concentration (Cavg)|Participant average nivolumab serum concentration|Day 1 and subsequent days after, up to 90 days|All treated participants|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2544440|NCT02960854|Primary|Trough Nivolumab Serum Concentration (Cmin)|Participant trough nivolumab serum concentration|Day 1 and subsequent days after, up to 90 days|All treated participants|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2544441|NCT02960854|Primary|Peak Nivolumab Serum Concentration (Cmax)|Participants peak nivolumab serum concentration|Day 1 and subsequent days after, up to 90 days|All Treated participants|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2544442|NCT02960854|Primary|Composite of Vital Signs and Electrocardiogram (ECG)|Includes body temperature, respiratory rate, blood pressure and heart rate. Blood pressure and heart rate should be measured after the participant has been resting quietly for at least 5 minutes.|Screening up to 90 days (Discharge)|All treated participants|||Percentage||Standard Deviation|Mean
2544443|NCT02960854|Primary|Percentage of Incidence Rates of Serious Adverse Events (SAEs), Adverse Events (AEs), Immune-mediated AEs, AEs Leading to Discontinuation, and Deaths||Screening, day -1, day 1 and subsequent days after, up to 90 days|All treated participants|||Percentage|||Number
2544444|NCT02960295|Secondary|Glucose Concentrations|Mean of all glucose measures during study, in mg/dl|1 year|Mean of all glucose measures during study, in mg/dl|||milligrams per deciliter||Standard Deviation|Mean
2544445|NCT02960295|Secondary|Compliance With Blood Pressure Checking Requirements|Percentage of required once-weekly blood pressure checks calculated as total blood pressure checks in study/weeks in study x 100|1 year|Percentage of required once-weekly blood pressure checks calculated as total blood pressure checks in study/weeks in study x 100|||percentage of Blood Pressure checks||Standard Deviation|Mean
2544446|NCT02960295|Secondary|Compliance With Self-weighing Requirements|Average percentage of weight checks per week in study, calculated as total weight checks in study/weeks in study x 100|1 year|Women with gestational diabetes|||percentage of weekly weights performed||Standard Deviation|Mean
2544447|NCT02960295|Primary|Compliance With Requirements for Frequency of Glucose Measures|Each patient is requested to check her blood glucose four times a day: fasting and one hour after the first bite of each meal. Compliance with this requirement will be measured for each patient by dividing the number of daily glucose checks actually performed by the number of days in the study.|1 year|women with gestational diabetes|||number of glucose checks per pt per day||Standard Deviation|Mean
2544448|NCT02960217|Secondary|Change From Baseline in CANTAB, Paired Associates Learning First Trial Memory Score (PALFTMS) at Treatment Week 10|CANTAB measures neuropsychological function using a standardized, computerized battery of tests designed to assess visual memory, working memory, new learning and reaction time. PALFTMS assesses the cognitive domain of episodic memory, with scores on a discrete, ordinal scale from 0 to 27; higher scores indicate better function.|Period Baseline (defined as the last non-missing assessment prior to or on the date of the first dose of study drug for each double-blind Treatment Period), Week 10|Full Analysis Set: all randomized participants (or parent/proxy) who received at least 1 dose of study drug. Participants who had an assessment.|||units on a scale||Standard Error|Least Squares Mean
2544449|NCT02960217|Secondary|Change From Baseline in CANTAB, Paired Associates Learning Total Errors (PALTEA) at Treatment Week 10|CANTAB measures neuropsychological function using a standardized, computerized battery of tests designed to assess visual memory, working memory, new learning and reaction time. PALTEA assesses the cognitive domain of episodic memory/new learning, with scores on a discrete, ordinal scale from 0 to 137; lower scores indicate better function.|Period Baseline (defined as the last non-missing assessment prior to or on the date of the first dose of study drug for each double-blind Treatment Period), Week 10|Full Analysis Set: all randomized participants (or parent/proxy) who received at least 1 dose of study drug. Participants who had an assessment.|||units on a scale||Standard Error|Least Squares Mean
2544450|NCT02960217|Secondary|Change From Period Baseline in CANTAB, Spatial Working Memory Strategy (SWMS) Scores at Treatment Week 10|CANTAB measures neuropsychological function using a standardized, computerized battery of tests designed to assess visual memory, working memory, new learning and reaction time. SWMS assesses the cognitive domain of executive function/strategy, with scores on a discrete, ordinal scale from 4 to 28; lower scores indicate better function.|Period Baseline (defined as the last non-missing assessment prior to or on the date of the first dose of study drug for each double-blind Treatment Period), Week 10|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants who had an assessment.|||units on a scale||Standard Error|Least Squares Mean
2544451|NCT02960217|Secondary|Change From Period Baseline in CANTAB, Spatial Working Memory Between Errors (SWMBE) Scores at Treatment Week 10|CANTAB measures neuropsychological function using a standardized, computerized battery of tests designed to assess visual memory, working memory, new learning and reaction time. SWMBE assesses the cognitive domain of working memory, with scores on a discrete, ordinal scale from 0 to 360; lower scores indicate better function.|Period Baseline (defined as the last non-missing assessment prior to or on the date of the first dose of study drug for each double-blind Treatment Period), Week 10|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants who had an assessment.|||units on a scale||Standard Error|Least Squares Mean
2544452|NCT02960217|Secondary|Change From Period Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB), Spatial Span (SSP) Span Length Scores at Treatment Week 10|Cognitive function as measured by the CANTAB. CANTAB measures neuropsychological function using a standardized, computerized battery of tests designed to assess visual memory, working memory, new learning and reaction time. SSP Span Length assesses the cognitive domain of sequential memory, with scores on a discrete, ordinal scale from 2 to 9; higher scores indicate better function.|Period Baseline (defined as the last non-missing assessment prior to or on the date of the first dose of study drug for each double-blind Treatment Period), Week 10|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants who had an assessment.|||units on a scale||Standard Error|Least Squares Mean
2544453|NCT02960217|Secondary|Duration of Movement Disorder Events During Maintenance Phase|Duration of disabling paroxysmal movement disorder events observed during the Maintenance Period of treatment, as recorded by the subject/caregiver in an event-based daily electronic Glut1 DS symptom diary.|Maintenance Phase (up to 22 weeks)|Full Analysis Set: all randomized participants (or parent/proxy) who received at least 1 dose of study drug.|||hours||Standard Deviation|Mean
2544454|NCT02960217|Secondary|Clinical Global Impression - Improvement (CGI-I) at Treatment Week 10|Participant/caregiver global impression of change in clinical status using the CGI-I. The CGI-I is a 7-point scale that assesses how much the participant's condition has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much better; 2=much better; 3=a little better; 4=no change; 5=a little worse; 6=much worse; 7=very much worse.|Week 10|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants who had an assessment.|||score on a scale||Standard Error|Least Squares Mean
2544455|NCT02960217|Secondary|Change From Period Baseline in PROMIS Health Assessment Questionnaire (Pediatric/Parent-Proxy Form) Peer Relationships Score at Treatment Week 10|The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013; NIH 2015) via parent/proxy. It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Peer Relationships Domain, decreases in score indicate worse functioning in peer relationships.|Period Baseline (defined as the last non-missing assessment prior to or on the date of the first dose of study drug for each double-blind Treatment Period), Week 10|Full Analysis Set: all randomized pediatric participants who received at least 1 dose of study drug. Participants who had an assessment.|||T-score||Standard Error|Least Squares Mean
2544477|NCT02959996|Secondary|Total Opioid Use (in Morphine Equivalents)|Total opioid use (in morphine equivalents)|72-hours post-operatively||||morphine milligram equivalents (MME)||Inter-Quartile Range|Median
2544478|NCT02959996|Secondary|Pain Score With Activity|"Pain score with activity. PAIN OUT scale, which is a 0-10 scale, where 10 is more pain.~4 patients in the placebo group and 7 patients in the liposomal bupivacaine group were discharged prior to the 72 hour assessment"|at 72 -hours post-operatively||||units on a scale||Inter-Quartile Range|Median
2547901|NCT02896361|Secondary|Subject Satisfaction|questionnaire on satisfaction with current therapy|assessed every 2 weeks after each intervention, for a total of 6 weeks||||Participants|||Count of Participants
2544456|NCT02960217|Secondary|Change From Period Baseline in PROMIS Health Assessment Questionnaire (Pediatric/Parent-Proxy Form) Pain Interference Score at Treatment Week 10|The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013; NIH 2015) via parent/proxy. It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Pain Interference Domain, decreases in score indicate less pain interference.|Period Baseline (defined as the last non-missing assessment prior to or on the date of the first dose of study drug for each double-blind Treatment Period), Week 10|Full Analysis Set: all randomized pediatric participants who received at least 1 dose of study drug. Participants who had an assessment.|||T-score||Standard Error|Least Squares Mean
2544457|NCT02960217|Secondary|Change From Period Baseline in PROMIS Health Assessment Questionnaire (Pediatric/Parent-Proxy Form) Fatigue Score at Treatment Week 10|The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013; NIH 2015) via parent/proxy. It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Fatigue Domain, decreases in score indicate less fatigue.|Period Baseline (defined as the last non-missing assessment prior to or on the date of the first dose of study drug for each double-blind Treatment Period), Week 10|Full Analysis Set: all randomized pediatric participants who received at least 1 dose of study drug. Participants who had an assessment.|||T-score||Standard Error|Least Squares Mean
2544458|NCT02960217|Secondary|Change From Period Baseline in PROMIS Health Assessment Questionnaire (Pediatric/Parent-Proxy Form) Upper Extremity Score at Treatment Week 10|The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013; NIH 2015) via parent/proxy. It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Upper Extremity Domain, decreases in score indicate less upper extremity movement.|Period Baseline (defined as the last non-missing assessment prior to or on the date of the first dose of study drug for each double-blind Treatment Period), Week 10|Full Analysis Set: all randomized pediatric participants who received at least 1 dose of study drug. Participants who had an assessment.|||T-score||Standard Error|Least Squares Mean
2544459|NCT02960217|Secondary|Change From Period Baseline in PROMIS Health Assessment Questionnaire (Pediatric/Parent-Proxy Form) Mobility Score at Treatment Week 10|The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013; NIH 2015) via parent/proxy. It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Mobility Domain, decreases in score indicate less mobility.|Period Baseline (defined as the last non-missing assessment prior to or on the date of the first dose of study drug for each double-blind Treatment Period), Week 10|Full Analysis Set: all randomized pediatric participants who received at least 1 dose of study drug. Participants who had an assessment.|||T-score||Standard Error|Least Squares Mean
2544460|NCT02960217|Secondary|Change From Period Baseline in PROMIS Health Assessment Questionnaire (Adult Form) Anxiety Score at Treatment Week 10|The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013; NIH 2015). It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Anxiety Domain, decreases in scores indicate less anxiety.|Period Baseline (defined as the last non-missing assessment prior to or on the date of the first dose of study drug for each double-blind Treatment Period), Week 10|Full Analysis Set: all randomized adult participants who received at least 1 dose of study drug. Participants who had an assessment.|||T-score||Standard Error|Least Squares Mean
2544461|NCT02960217|Secondary|Change From Period Baseline in PROMIS Health Assessment Questionnaire (Adult Form) Social Roles and Activities Score at Treatment Week 10|The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013; NIH 2015). It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Social Roles and Activities Domain, decreases in score indicate worse /less or decrease of performance in social roles and activities.|Period Baseline (defined as the last non-missing assessment prior to or on the date of the first dose of study drug for each double-blind Treatment Period), Week 10|Full Analysis Set: all randomized adult participants who received at least 1 dose of study drug. Participants who had an assessment.|||T-score||Standard Error|Least Squares Mean
2544462|NCT02960217|Secondary|Change From Period Baseline in PROMIS Health Assessment Questionnaire (Adult Form) Cognitive Function Score at Treatment Week 10|The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013; NIH 2015). It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. The Cognitive Function Domain measures cognitive function impairment. Decreases in score indicate less cognitive function impairment.|Period Baseline (defined as the last non-missing assessment prior to or on the date of the first dose of study drug for each double-blind Treatment Period), Week 10|Full Analysis Set: all randomized adult participants who received at least 1 dose of study drug. Participants who had an assessment.|||T-score||Standard Error|Least Squares Mean
2544463|NCT02960217|Secondary|Change From Period Baseline in PROMIS Health Assessment Questionnaire (Adult Form) Pain Interference Score at Treatment Week 10|The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013; NIH 2015). It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Pain Interference Domain, decreases in scores indicate less pain interference.|Period Baseline (defined as the last non-missing assessment prior to or on the date of the first dose of study drug for each double-blind Treatment Period), Week 10|Full Analysis Set: all randomized adult participants who received at least 1 dose of study drug. Participants who had an assessment.|||T-score||Standard Error|Least Squares Mean
2544479|NCT02959996|Primary|Pain Score With Activity|"Pain score with activity. PAIN OUT scale, which is a 0-10 scale, where 10 is more pain.~2 patients in the liposomal bupivacaine group were discharged prior to 48 hour assessment, therefore denominator for this outcome is 37, not 39"|at 48-hours post-operatively||||units on a scale||Inter-Quartile Range|Median
2544464|NCT02960217|Secondary|Change From Period Baseline in PROMIS Health Assessment Questionnaire (Adult Form) Sleep Disturbance Score at Treatment Week 10|The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013; NIH 2015). It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Sleep Disturbance Domain, decreases in score indicate less sleep disturbance.|Period Baseline (defined as the last non-missing assessment prior to or on the date of the first dose of study drug for each double-blind Treatment Period), Week 10|Full Analysis Set: all randomized adult participants who received at least 1 dose of study drug. Participants who had an assessment.|||T-score||Standard Error|Least Squares Mean
2544465|NCT02960217|Secondary|Change From Period Baseline in PROMIS Health Assessment Questionnaire (Adult Form) Fatigue Score at Treatment Week 10|The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013; NIH 2015). It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Fatigue Domain, decreases in score indicate less fatigue.|Period Baseline (defined as the last non-missing assessment prior to or on the date of the first dose of study drug for each double-blind Treatment Period), Week 10|Full Analysis Set: all randomized adult participants who received at least 1 dose of study drug. Participants who had an assessment.|||T-score||Standard Error|Least Squares Mean
2544466|NCT02960217|Secondary|Change From Period Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Health Assessment Questionnaire (Adult Form) Physical Function Score at Treatment Week 10|The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013; NIH 2015). It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Physical Function Mobility Domain, increases in score indicate greater mobility.|Period Baseline (defined as the last non-missing assessment prior to or on the date of the first dose of study drug for each double-blind Treatment Period), Week 10|Full Analysis Set: all randomized adult participants who received at least 1 dose of study drug. Participants who had an assessment.|||T-score||Standard Error|Least Squares Mean
2544467|NCT02960217|Secondary|Change From Period Baseline in 12 Minute Walk Test (12MWT) Distance at Treatment Week 10|Walking capacity and endurance, as determined by the distance in meters walked in 12 minutes during the 12MWT.|Period Baseline (defined as the last non-missing assessment prior to or on the date of the first dose of study drug for each double-blind Treatment Period), Week 10|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants who had an assessment.|||meters||Standard Error|Least Squares Mean
2544468|NCT02960217|Primary|Baseline and Post-Baseline Columbia Suicide Severity Rating Scale (C-SSRS) Responses During Double-Blind Treatment Period|The C-SSRS is a participant-rated questionnaire to assess suicidal ideation, suicidal behavior, and self-injurious behavior with no suicidal intent (yes or no responses). Positive responses (i.e., 'Yes') to C-SSRS questions correspond to events in these categories with the exception of the category 'No events'. Suicidal ideation includes the following subcategories: passive; active-nonspecific; active-method/no intent/no plan; active-intent/with or without method/no plan; active-method/intent/plan. Suicidal behavior includes the following subcategories: suicide attempt; interrupted attempt; aborted attempt; preparatory actions toward immanent suicidal behaviors; completed suicide. Suicidal ideation and/or suicidal behavior category includes participants with positive responses in the category suicidal ideation and/or suicidal behavior.|Baseline, up to Week 22|Safety Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with a baseline (BL) and postbaseline (PB) assessment.|||Participants|||Count of Participants
2544469|NCT02960217|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs|An Adverse Event (AE) was defined as any untoward medical occurrence, whether or not considered drug related. Serious adverse events (SAE) was defined as an AE that at any dose, in the view of either the Investigator or Ultragenyx, results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or disability (substantial disruption of the ability to conduct normal life functions); a congenital anomaly/birth defect; other important medical event. All reported AEs with with a start date that occurred or worsened in severity on or after the first dose of study drug in the corresponding treatment period and before the first dose of study drug in the next treatment period were defined as TEAEs. AEs were graded as 1=mild, 2=moderate, 3=severe, 4=life=threatening, 5=death.|From first dose of study drug through 30-35 days after final dose. Mean (SD) treatment duration was 65.7 (12.06) and 68.3 (7.04) days for double-blind UX007 and placebo, and 305.0 (122.71) days for open-label UX007.|Safety Analysis Set: all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2544470|NCT02960217|Primary|Maintenance Phase Movement Disorder Frequency|The frequency of paroxysmal movement disorders captured as disabling movement disorder events (normalized to a 4-week rate) observed during the Maintenance Phase in participants treated with UX007 versus placebo, as recorded by the subject/caregiver in an event-based daily Glut1 DS symptom diary.|Maintenance Phase (up to Week 22)|Full Analysis Set: all randomized participants who received at least 1 dose of study drug.|||movement disorder events per 4 weeks||Full Range|Median
2544471|NCT02959996|Secondary|Patient Satisfaction With Pain Management at 6w Postpartum|Phone follow up to ascertain satisfaction with pain control, Likert 5 point scale used|6 weeks postpartum||||Participants|||Count of Participants
2544472|NCT02959996|Secondary|Operative Time of Cesarean Delivery|Operative time of cesarean delivery|Intraoperative time measurement, from skin incision to skin closure. Measured within 24h of admission.||||hours||Inter-Quartile Range|Median
2544473|NCT02959996|Secondary|Number of Patients With Allergic Reaction Attributable to Local Anesthestic|incisional rash, hives, anaphylaxis|0-96 hours postoperatively||||Participants|||Count of Participants
2544474|NCT02959996|Secondary|Number of Patients With Wound Complication - Separation, Dehiscence, Infection|Wound complication - separation, dehiscence, infection|14 days postoperatively||||Participants|||Count of Participants
2544475|NCT02959996|Secondary|Postoperative Hospital Length of Stay|Postoperative hospital length of stay|0 to 96 hours postoperatively||||days||Standard Deviation|Mean
2544480|NCT02959983|Secondary|Percentage of Monthly Composite Responders|Percentage of monthly composite responders is defined as the percentage of participants who meet the daily composite response criteria for at least 50% of days with diary entry for a minimum of 20 days during each 4-week interval (weeks 1 to 4, 5 to 8, and 9 to 12). Composite response includes both of the following criteria: 1) WAP score improved by ≥40% compared to Baseline. The participant records their WAP score in the past 24 hours each day in a daily patient diary where: 0=no pain to 10=worst imaginable pain. 2) BSS <5; or the absence of a bowel movement if accompanied by ≥40% improvement in WAP compared to Baseline. The participant records their stool consistency each day in a daily patient diary using the BSS on a scale from 1 (hard stool) to 7 (watery stool).|Weeks 1 to 4, 5 to 8, and 9 to 12|The Intent-to-Treat population includes all randomized patients.|||Percentage of Participants|||Number
2544481|NCT02959983|Secondary|Percentage of Pain Responders|Percentage of pain responders is defined as the percentage of participants who meet the daily pain response criteria: WAP score improved by ≥40% compared to Baseline for ≥50% of days with diary entries over a certain time period. The participant records their WAP score in the past 24 hours each day in a daily diary where: 0=no pain to 10=worst imaginable pain. A participant must have had a minimum of 20 days of diary entries over any 4-week interval.|Baseline, Weeks 1 to 12 and 4-week intervals (Weeks 1 to 4, Weeks 5 to 8 and Weeks 9 to 12)|The Intent-to-Treat population includes all randomized patients.|||Percentage of Participants|||Number
2544482|NCT02959983|Secondary|Percentage of Stool Consistency Responders|Percentage of stool consistency responders is defined as the percentage of participants who meet the daily stool consistency response criteria: BSS <5; or the absence of a bowel movement if accompanied by ≥40% improvement in WAP compared to Baseline for ≥50% of days with daily patient diary entries over a certain time period. The participant records their stool consistency each day in a daily patient diary using the BSS on a scale from 1 (hard stool) to 7 (watery stool). A participant must have had a minimum of 20 days of diary entries over any 4-week interval.|Weeks 1 to 12 and 4-week intervals (Weeks 1 to 4, Weeks 5 to 8 and Weeks 9 to 12)|The Intent-to-Treat population includes all randomized patients.|||Percentage of Participants|||Number
2544483|NCT02959983|Primary|Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores|Percentage of primary composite responders is defined as the percentage of participants who meet both of the following daily composite criteria for at least 50% of the days with diary entry: 1)Worst Abdominal Pain (WAP) score improved by ≥40% compared to Baseline. The participant records their WAP score in the past 24 hours each day in a daily patient diary where: 0=no pain to 10=worst imaginable pain. 2) Bristol Stool Score (BSS) <5; or the absence of a bowel movement if accompanied by ≥40% improvement in WAP compared to Baseline. The participant records their stool consistency each day in a daily patient diary using the BSS on a scale from 1 (hard stool) to 7 (watery stool).|Baseline, Weeks 1 to 12|The Intent-to-Treat population includes all randomized patients.|||percentage of participants|||Number
2544484|NCT02959970|Other Pre-specified|Percentage of Participants With None (0) or Minimal (1) Score Plus at Least a 2-Grade Improvement on the Investigator's Global Assessment (IGA) for Face|Overall severity of acne vulgaris was evaluated by using a 5-point IGA scale: Clear (0) - (no comedones; papules or pustules, residual hyperpigmentation and erythema may be present); Almost clear (1) - (rare comedones; no more than a few small papules and pustules); Mild (2) - (easily recognizable comedones in limited numbers; +/- presence of small papules and pustules); Moderate (3) - (many comedones; +/- easily recognizable small and medium-sized papules; no nodules or cysts; Severe (4) - (widespread and numerous comedones; many small, medium-sized and large papules and pustules; nodules or cysts may or may not be present).|Week 12|Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment.This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).|||percentage of participants|||Number
2544485|NCT02959970|Other Pre-specified|Percentage of Participants With None (0) or Minimal (1) Score on the Investigator's Global Assessment (IGA) for Face|Overall severity of acne vulgaris was evaluated by using a 5-point IGA scale: Clear (0) - (no comedones; papules or pustules, residual hyperpigmentation and erythema may be present); Almost clear (1) - (rare comedones; no more than a few small papules and pustules); Mild (2) - (easily recognizable comedones in limited numbers; +/- presence of small papules and pustules); Moderate (3) - (many comedones; +/- easily recognizable small and medium-sized papules; no nodules or cysts; Severe (4) - (widespread and numerous comedones; many small, medium-sized and large papules and pustules; nodules or cysts may or may not be present).|Week 12|Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment. This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).|||percentage of participants|||Number
2544486|NCT02959970|Other Pre-specified|Percent Change From Baseline in Total Lesion Counts on Face|Total lesion counts were defined as the sum of inflammatory lesion counts and noninflammatory lesion counts (face only).|Baseline (Day 1), Week 12|Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment. This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).|||percent change||Standard Deviation|Mean
2544487|NCT02959970|Other Pre-specified|Absolute Change From Baseline in Total Lesion Counts on Face|Total lesion counts were defined as the sum of inflammatory lesion counts and noninflammatory lesion counts (face only). Change from baseline was be calculated by subtracting post-dose value from the baseline value.|Baseline (Day 1), Week 12|Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment.This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).|||lesions||Standard Deviation|Mean
2544488|NCT02959970|Other Pre-specified|Percent Change From Baseline in Non-inflammatory Lesion Counts|Noninflammatory lesion counts were defined as the sum of counts of the following lesion type (face only): open comedone - a pigmented dilated pilosebaceous orifice (blackhead); closed comedone - a tiny white papule (whitehead).|Baseline (Day 1), Week 12|Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment. This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).|||percent change||Standard Deviation|Mean
2544489|NCT02959970|Other Pre-specified|Absolute Change From Baseline in Non-inflammatory Lesion Counts|Non-inflammatory lesion counts were defined as the sum of counts of the following lesion type (face only): open comedone - a pigmented dilated pilosebaceous orifice (blackhead); closed comedone - a tiny white papule (whitehead). Change from baseline was be calculated by subtracting post-dose value from the baseline value.|Baseline (Day 1), Week 12|Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment. This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).|||lesions||Standard Deviation|Mean
2544490|NCT02959970|Other Pre-specified|Percent Change From Baseline in Inflammatory Lesion Counts|Inflammatory lesion counts were the sum of counts of the following lesion types (face only): Papule - a small, red, solid elevation less than 1.0 cm in diameter; Pustule - a small, circumscribed elevation of the skin that contains yellow-white exudate; Nodule - a circumscribed, elevated, solid lesion generally more than 1.0 cm in diameter with palpable depth; Cyst - a smooth, dome-shaped, elevated, freely moveable, skin colored, round to ovoid lesion greater than 0.7 cm in diameter.|Baseline (Day 1), Week 12|Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment.This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).|||percent change||Standard Deviation|Mean
2544491|NCT02959970|Other Pre-specified|Absolute Change From Baseline in Inflammatory Lesion Counts|Inflammatory lesion counts were the sum of counts of the following lesion types (face only): Papule - a small, red, solid elevation less than (<) 1.0 centimeter (cm) in diameter; Pustule - a small, circumscribed elevation of the skin that contains yellow-white exudate; Nodule - a circumscribed, elevated, solid lesion generally more than 1.0 cm in diameter with palpable depth; Cyst - a smooth, dome-shaped, elevated, freely moveable, skin-colored, round to ovoid lesion greater than 0.7 cm in diameter. Change from baseline was calculated by subtracting post-dose value from baseline value.|Baseline (Day 1), Week 12|Modified intent-to-treat (mITT) population included all enrolled participants who had a baseline assessment and at least one post-baseline assessment. This population was presented as combined data from both cohorts (PK Cohort: ACZONE 7.5% and Non-PK Cohort: ACZONE 7.5%).|||lesions||Standard Deviation|Mean
2544492|NCT02959970|Other Pre-specified|Trough Plasma Concentration of Dapsone, Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1|The trough plasma concentrations of Dapsone, Dapsone hydroxylamine and N-acetyl dapsone were reported.|Week 1 (Pre-dose)|Pharmacokinetic (PK) population included all participants who received applications of study drug for at least 8 days under maximal use conditions and had evaluable blood samples for PK analysis.|||ng/mL||Standard Deviation|Mean
2544493|NCT02959970|Other Pre-specified|Peak Plasma Concentration of Dapsone,Dapsone Hydroxylamine and N-acetyl Dapsone at Week 1|The mean plasma peak (10 hours postdose) concentrations of dapsone, dapsone hydroxylamine and N-acetyl dapsone were reported.|Week 1 (Pre-dose and 10 hours post-dose)|Pharmacokinetic (PK) population included all participants who received applications of study drug for at least 8 days under maximal use conditions and had evaluable blood samples for PK analysis.|||nanogram per milliter (ng/mL)||Standard Deviation|Mean
2544494|NCT02959970|Primary|Local Dermal Tolerability: Number of Participants With Stinging/Burning Symptoms as Assessed by Participants|Local dermal tolerability was evaluated by participants in terms of presence and absence of prickling pain sensation immediately after (within 5 minutes of dosing) and its severity in the areas of body where medication was applied (face). Stinging/burning symptoms were graded on a 4-point scale of 0 - 3 where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling/stinging sensation; not really bothersome), 2 = moderate (definite warm, tingling/stinging sensation that is somewhat bothersome), 3 = severe (hot, tingling/stinging sensation that has caused definite discomfort). The higher score indicated severe symptoms.|Week 12|Safety population included all participants who received at least one application of study drug. Here, “number analyzed” signifies number of participants with available data for the specified category.|||participants|||Number
2544495|NCT02959970|Primary|Local Dermal Tolerability: Number of Participants With Dryness, Scaling and Erythema as Assessed by Investigator|Local dermal tolerability was evaluated by investigator in terms of presence and absence of dryness, scaling and erythema symptoms and its severity in the areas of body where medication was applied. These symptoms were assessed by using a 4 - point scale of 0 - 3, where 0 = none (no dryness, scaling and erythema) and 3 = severe (marked roughness, heavy scale production and intense redness). The higher score indicated severe symptoms.|Week 12|Safety population included all participants who received at least one application of study drug. Here, “number analyzed” signifies number of participants with available data for the specified category.|||participants|||Number
2544496|NCT02959970|Primary|Change From Baseline in Height|Change from baseline in height was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.|Baseline (Day 1), Week 12|Safety population included all participants who received at least one application of study drug.|||centimeter (cm)||Standard Deviation|Mean
2544497|NCT02959970|Primary|Change From Baseline in Weight|Change from baseline in weight was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.|Baseline (Day 1), Week 12|Safety population included all participants who received at least one application of study drug.|||kilogram (kg)||Standard Deviation|Mean
2544498|NCT02959970|Primary|Change From Baseline in Body Temperature|Change from baseline in body temperature was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.|Baseline (Day 1), Week 12|Safety population included all participants who received at least one application of study drug.|||degree celsius (°C)||Standard Deviation|Mean
2544499|NCT02959970|Primary|Change From Baseline in Respiratory Rate|Change from baseline in respiratory rate was assessed. Change from baseline was calculated by subtracting post-dose value from baseline value.|Baseline (Day 1), Week 12|Safety population included all participants who received at least one application of study drug.|||breaths per minute (breaths/min)||Standard Deviation|Mean
2544500|NCT02959970|Primary|Change From Baseline in Heart Rate|Change from baseline in heart rate was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.|Baseline (Day 1), Week 12|Safety population included all participants who received at least one application of study drug.|||beats per minute (beats/min)||Standard Deviation|Mean
2544539|NCT02959814|Secondary|Participants With Myocardial Infarction (Number of Patients)|Peri-procedural myocardial infarction|1 day||||Participants|||Count of Participants
2544501|NCT02959970|Primary|Change From Baseline in Systolic and Diastolic Blood Pressure|Change from baseline in systolic and diastolic blood pressure was evaluated. Change from baseline was calculated by subtracting post-dose value from baseline value.|Baseline (Day 1), Week 12|Safety population included all participants who received at least one application of study drug.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2544502|NCT02959970|Primary|Number of Participants With Adverse Events (AE)|"An AE was defined as any untoward medical occurrence in a clinical trial participant (regardless of the administration of the study drug and its causal relationship to it). An AE could therefore, be any unfavorable and unintended medical occurrence during the participant's participation in the trial, including deterioration of a pre-existing medical condition, an abnormal clinically significant finding in a laboratory assessment, or an abnormal clinically significant finding in the physical examination or vital sign."|From Baseline (Day 1) until Week 12|Safety population included all participants who received at least one application of study drug.|||Participants|||Count of Participants
2544503|NCT02959892|Secondary|Change in BP-ND in the TAK-041+AMPH Condition Compared to AMPH Alone as a Function of the Dose of TAK-041 Administered|The effect of predosing with TAK-041 on the AMPH challenge was calculated as the relative change in the percentage reduction in specific binding in ROI in the AMPH+TAK-041 condition compared to AMPH alone.|Baseline (Day 1 of Confinement Period 1), and Day 1 post-TAK-041 and AMPH dose in Confinement Period 2|The safety analysis set consisted of all participants who were enrolled and received a dose of study drug ([11C]PHNO, AMPH, or TAK-041) as part of this study.|||percentage of reduction||Standard Deviation|Mean
2544504|NCT02959892|Primary|Change in Non-displaceable Binding Potential (BP-ND) in the TAK-041+AMPH Condition Compared to AMPH Alone|The AMPH-induced change in binding potential relative to the non-displaceable component in the basal ganglia (putamen [Pu], ventral striatum [VSt]) which was the region of interest (ROI) was calculated as the percentage of reduction in specific binding from Baseline to postdose following AMPH.|Baseline (Day 1 of Confinement Period 1) and Day 2 post-AMPH dose in Confinement Period 1|The safety analysis set consisted of all participants who were enrolled and received a dose of study drug ([11C]PHNO, AMPH, or TAK-041) as part of this study.|||percentage of reduction||Standard Deviation|Mean
2544505|NCT02959866|Secondary|Increase in Income|Self-reported increase in income through accessing a financial benefit|4 weeks||||Participants|||Count of Participants
2544506|NCT02959866|Primary|Awareness of Financial Benefits|Self-reported awareness of at least one financial benefit|4 weeks|This the the number of people who used the tool to completion with their healthcare provider|||Participants|||Count of Participants
2544507|NCT02959853|Secondary|Percent Change in Bone Quality|Percent change in bone quality as measured by high resolution peripheral quantitative computed tomography scan (HR-pQCT), at baseline and 6 months|baseline and 6 months||||percent change||Standard Deviation|Mean
2544508|NCT02959853|Secondary|Percent Change in Bone Mineral Density|Percent change in bone mineral density as measured by DXA scan, done at baseline and 6 months|baseline and 6 months||||percent change||Standard Deviation|Mean
2544509|NCT02959853|Secondary|Change in Visceral Adipose Tissue (in Grams)|Change in absolute visceral adipose tissue as measured by DXA scan, done at baseline and 6 months.|baseline and 6 months||||grams||Standard Deviation|Mean
2544510|NCT02959853|Secondary|Change in Fat Mass (in Kilograms)|change in fat was measured by Dual-energy X-ray absorptiometry (DXA) scan at baseline and 6 months only.|baseline and 6 months||||kilograms||Standard Deviation|Mean
2544511|NCT02959853|Primary|Change in Symptoms Score of Hypogonadism|"Symptoms of androgen deficiency were measured with 3 validated questionnaires done at baseline, 3 and 6 months.~The Quantitative Androgen Deficiency in the Aging Male (qADAM) questionnaire uses questions from a scale of 1-5. The final summation yields a total score between 10 (most symptomatic) and 50 (least symptomatic).~The second questionnaire used was the International Index of Erectile Function (IIEF). Total score ranges from 5 to 25, with 5 being severe erectile dysfunction and 25 being no erectile dysfunction.~The third questionnaire used was the Impact of Weight on Quality of Life Questionnaire-Lite (IWQOL-lite). Total score ranges from 31 to 155, with 31 being least symptomatic and 155 being the most symptomatic.~Score change at 3 months calculated by: total score at 3 months minus total score at baseline~Score change at 6 months calculated by: total score at 6 months minus total score at baseline"|baseline, 3 and 6 months||||score on scale (qADAM, IIEF, IWQOL-lite)||Standard Deviation|Mean
2544512|NCT02959853|Primary|Percent Change in Muscle Strength as Assessed by Knee Extension and Knee Flexion|"Muscle strength was assessed using Biodex System 4 Isokinetic Dynamometer (Shirley, NY). Peak torque for isokinetic knee extension and flexion was measured at baseline, 6 months on the right leg. During the testing, participants sat with their hips flexed at 120 degrees, secured with thigh and pelvic straps. Testing was performed at an angular velocity of 60 degrees per second. The best result of 3 maximal voluntary efforts for each knee flexion and extension was used as the measure of absolute strength and reported as peak torque at 60 degrees in Newton-meter (N*m) units.~The higher the measured Newton-meter (N*m), the greater the measured muscle strength."|baseline and 6 months||||Percent change in muscle strength||Standard Deviation|Mean
2544513|NCT02959840|Secondary|Overall Anesthetic Care Satisfaction|Patients are asked their overall anesthetic care satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Data are expressed as number of parturients who gave a score of 8 or higher.|During the surgical procedure||||Participants|||Count of Participants
2544514|NCT02959840|Secondary|Satisfaction of Anti-emetic Treatment|Patients are asked their anti-emetic treatment satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Data are expressed as number of parturients who gave a score of 8 or higher.|During the surgical procedure||||Participants|||Count of Participants
2544515|NCT02959840|Secondary|Vomiting During Stage IV (the Rest of the Time Until Arrival at PACU)|The investigators will perform objective assessments of whether or not the patients have vomited during stage IV. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.|During the surgical procedure||||Participants|||Count of Participants
2544516|NCT02959840|Secondary|Vomiting During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)|The investigators will perform objective assessments of whether or not the patients have vomited during stage III. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.|During the surgical procedure||||Participants|||Count of Participants
2544517|NCT02959840|Secondary|Vomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)|The investigators will perform objective assessments of whether or not the patients have vomited during stage II. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.|During the surgical procedure||||Participants|||Count of Participants
2544518|NCT02959840|Secondary|Vomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus)|The investigators will perform objective assessments of whether or not the patients have vomited during stage I. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.|During the surgical procedure||||Participants|||Count of Participants
2544519|NCT02959840|Secondary|Nausea During Stage IV (the Rest of the Time Until Arrival at PACU)|Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage IV. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.|During the surgical procedure||||Participants|||Count of Participants
2544520|NCT02959840|Secondary|Nausea During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)|Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage III. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.|During the surgical procedure||||Participants|||Count of Participants
2544521|NCT02959840|Secondary|Nausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)|Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage II. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.|During the surgical procedure||||Participants|||Count of Participants
2544522|NCT02959840|Secondary|Nausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus)|Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage I. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.|During the surgical procedure||||Participants|||Count of Participants
2544523|NCT02959840|Primary|Vomiting|The investigators will perform objective assessments of whether or not the patients have vomited during the procedure. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.|During the surgical procedure||||Participants|||Count of Participants
2544524|NCT02959840|Primary|Nausea|The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea at any point during the surgical procedure in each group.|During the surgical procedure||||Participants|||Count of Participants
2544525|NCT02959827|Secondary|Classification of Hypothyroidism by Etiology||Up to 365 days after a diagnostic scan with iodinated contrast agent||||Participants|||Count of Participants
2544526|NCT02959827|Secondary|Classification of Subclinical/Manifest Hypothyroidism by Type of Exposure||Up to 365 days after a diagnostic scan with iodinated contrast agent||||Participants|||Count of Participants
2544527|NCT02959827|Secondary|Time From First Iodinated Contrast to First Hypothyroidism Event||Up to 365 days after a diagnostic scan with iodinated contrast agent||||Participants|||Count of Participants
2544528|NCT02959827|Secondary|Baseline Characteristics (Race/Ethnicity) of the Cases With Hypothyroidism and of the Rest of the Cohort||Up to 365 days after a diagnostic scan with iodinated contrast agent||||Participants|||Count of Participants
2544529|NCT02959827|Secondary|Baseline Characteristics (Type of Iodine Contrast Exposure) of the Cases With Hypothyroidism and of the Rest of the Cohort||Up to 365 days after a diagnostic scan with iodinated contrast agent||||Iodine contrast exposure|Iodine contrast exposure||Count of Units
2544530|NCT02959827|Secondary|Baseline Characteristics (Year of Hypothyroidism Diagnosis) of the Cases With Hypothyroidism and of the Rest of the Cohort||Up to 365 days after a diagnostic scan with iodinated contrast agent||||Participants|||Count of Participants
2544531|NCT02959827|Secondary|Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort||Up to 365 days after a diagnostic scan with iodinated contrast agent||||Participants|||Count of Participants
2544532|NCT02959827|Secondary|Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort||Up to 365 days after a diagnostic scan with iodinated contrast agent||||Participants|||Count of Participants
2544533|NCT02959827|Primary|Incidence Rate of Hypothyroidism Detected in Routine Clinical Practice|Incidence density rates (IDR) were calculated as the number of cases over the person time at risk where the numerator was the number of cases and the denominator was the person years at risk.|In the 365 days post exposure to an iodinated contrast agent||||events per 1,000 person years||95% Confidence Interval|Mean
2544534|NCT02959814|Secondary|Fluoroscopy Time|Fluoroscopy time for total procedure|1 hour||||Minutes||Standard Deviation|Mean
2544535|NCT02959814|Secondary|Contrast Use|Volume of contrast for total procedure|1 hour||||mL||Standard Deviation|Mean
2544536|NCT02959814|Secondary|Time to QFR After Receiving Angiographic Images|Time from first image evaluation on QFR computer until TIMI frame count based QFR value is obtained|1 hour||||Minutes||Inter-Quartile Range|Mean
2544537|NCT02959814|Secondary|Time to FFR|Time from starting preparations to do FFR (e.g. ordering assistants to prepare pressure wire, adenosine infusion etc.) to FFR value is obtained and drift has been verified to be within the prespecified limits|1 hour||||Minutes||Inter-Quartile Range|Median
2544538|NCT02959814|Secondary|All-cause Mortality (Number of Patients)|Peri-procedural mortality|1 day||||Participants|||Count of Participants
2544540|NCT02959814|Secondary|Diagnostic Accuracy of TIMI-flow Based QFR in Comparison to 2D QCA (>50% Diameter Stenosis)|"Comparison of proportion of participants correctly classified by QFR and 2D QCA using FFR as reference standard.~Diagnostic accuracy is defined as (true positives + false negatives) / (true positives+false positives+true negatives+false negatives).~Positive FFR is defined as FFR≤0.80. Positive QFR is defined as QFR≤0.80. Negative FFR is defines as FFR>0.80. Negative QFR is defines as QFR>0.80. Positive 2D QCA is defined as 2D-QCA % percent diameter stenosis >50. Negative 2D QCA is defined as 2D-QCA % diameter stenosis≤50."|1 hour||||Proportion|||Number
2544541|NCT02959814|Secondary|Diagnostic Grey Zone Calculation. QFR Limits for Achieving 95% Sensitivity and Specificity in Comparison to FFR|"QFR limits to yield 95% sensitivity and specificity. The QFR limits are identified by Area under the receiver operating curve analysis.~QFR limits are defined as the numerical QFR ratios (0-1.00)."|1 hour||||Ratio|||Number
2544542|NCT02959814|Secondary|Diagnostic Performance of QFR in Comparison to FFR Reported as Positive and Negative Likelihood Ratio|Positive likelihood ratio is defined as sensitivity/(1-specificity). Negative likelihood ratio is defined as (1-sensitivty)/specificity|1 hour||||Ratio||95% Confidence Interval|Mean
2544543|NCT02959814|Secondary|Proportion of Patients With Negative FFR (True Negatives) of Patients With Negative QFR (Negative Predictive Value)|Negative FFR is defined as FFR>0.80. Negative QFR is defined as QFR>0.80|1 hour||||Proportion||95% Confidence Interval|Mean
2544544|NCT02959814|Secondary|Proportion of Patients With Positive FFR (True Positives) of Patients With Positive QFR (Positive Predictive Value)|Positive FFR is defined as FFR≤0.80. Positive QFR is defined as QFR≤0.80|1 hour||||Proportion||95% Confidence Interval|Mean
2544545|NCT02959814|Secondary|Proportion of Patients With Negative QFR of FFR Negative Patients (True Negatives) (Specificity)|Negative FFR is defined as FFR>0.80. Negative QFR is defined as QFR>0.80|1 hour||||Proportion||95% Confidence Interval|Mean
2544546|NCT02959814|Secondary|Proportion of Patients With Positive QFR of FFR Positive Patients (True Positives) (Sensitivity)|Positive FFR is defined as FFR≤0.80. Positive QFR is defined as QFR≤0.80|1 hour||||Proportion||95% Confidence Interval|Mean
2544547|NCT02959814|Secondary|Percentage of Patients With Successful QFR in Patients With Successful FFR (Feasibility)||1 hour|Patients with successful FFR Measurement before Exclusion based on missing QFR and/or 2D-QCA|||Participants|||Count of Participants
2544548|NCT02959814|Primary|Specificity: Proportion of Patients With Negative QFR of FFR Negative Patients (True Negatives) Compared to Proportion of Patients With Negative DS% Assessed by 2D QCA of FFR Negative Patients (True Negatives)|Negative FFR is defined as FFR>0.80. Negative QFR is defined as QFR>0.80. Negative DS% is defined as DS% ≤ 50%.|1 hour||||Proportion||95% Confidence Interval|Mean
2544549|NCT02959814|Primary|Sensitivity: Proportion of Patients With Positive QFR of FFR Positive Patients (True Positives) Compared to Proportion of Patients With Positive Percentual Diameter Stenosis (DS%) Assessed by 2D QCA of FFR Positive Patients (True Positives)|Positive FFR is defined as FFR≤0.80. Positive QFR is defined as QFR≤0.80. Positive DS% is defined as DS% > 50%|1 hour||||Proportion||95% Confidence Interval|Mean
2544550|NCT02959437|Secondary|Parts 1 and 2: Duration of Response Based on RECIST v1.1|Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.|Every 9 weeks for the duration of study participation; estimated minimum of 6 months.|||||||
2544551|NCT02959437|Secondary|Parts 1 and 2: Progression-free Survival Based on RECIST v1.1.|Defined as the time from date of first dose of study drug until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.|Every 9 weeks for the duration of study participation; estimated minimum of 6 months.|||||||
2544552|NCT02959437|Secondary|Parts 1 and 2: Percentage of Responders Determined by Immunohistochemistry|Responder is defined as an increase in the number of tumor-infiltrating lymphocytes or the ratio of CD8+ lymphocytes to T regulatory cells infiltrating tumor post-treatment versus pretreatment with pembrolizumab and epacadostat in combination with azacitidine.|Baseline and Week 5 or Week 6.|||||||
2544553|NCT02959437|Secondary|Part 2: Safety and Tolerability Assessed by Number of Participants With Adverse Events|A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug. A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).|Baseline through 42-49 days after end of treatment, estimated up to 27 months (24 months with 100 day FU period).|||||||
2544554|NCT02959437|Secondary|Part 1: Objective Response Rate Based on RECIST v1.1|Defined as the percentage of subjects having a complete response or partial response.|Every 9 weeks for the duration of study participation; estimated minimum of 6 months.|||||||
2544555|NCT02959437|Primary|Part 1 and 2: Objective Response Rate Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. A participant was considered as an objective responder if the participant had a best overall response of CR or PR.|Every 9 weeks for the duration of study participation; estimated minimum of 6 months.|The response evaluable population includes all subjects enrolled in the study who received at least 1 dose of study drug, completed a baseline scan and have at least 1 post baseline scan, or has been on study for a minimum of 70 days of follow-up or who discontinued treatment. No participants enrolled in Treatment Groups B and C.|||Participants|||Count of Participants
2544634|NCT02957747|Primary|Composite Abuse Scale|30 item measure of chronicity and occurrence of intimate partner violence with current partner in past 12 months. Score range from 0-150; higher scores indicate more intimate partner violence (i.e., worse outcome).|2 month follow up||||score on a scale||Standard Deviation|Mean
2544556|NCT02959437|Primary|Part 1 and 2: Safety and Tolerability Assessed by Number of Participants With Adverse Events|Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug|Baseline through 42-49 days after end of treatment, estimated minimum of 6 months.|The safety population includes all subjects enrolled in the study who received at least 1 dose of study drug. Data is presented for Group A only, no participants enrolled in Treatment Groups Band C.|||Participants|||Count of Participants
2544557|NCT02959177|Secondary|Total Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)|Total Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)|Month 6|All randomized participants who received at least one dose of study drug and had measurable CGRP concentrations.|||nanograms per milliliter||Standard Deviation|Mean
2544558|NCT02959177|Secondary|Pharmacokinetics (PK): Serum Concentration of Galcanezumab|Pharmacokinetics (PK): Serum Concentration of Galcanezumab|Month 6|All randomized participants who received at least one dose of study drug and had measurable serum concentrations.|||nanograms per milliliter||Standard Deviation|Mean
2544559|NCT02959177|Secondary|Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab|"Treatment emergent ADA will be defined as any of the following:~A negative baseline result and a positive post-baseline ADA result with a titer ≥20. This is also called treatment-induced ADA.~A positive baseline result and a positive post-baseline ADA result with a ≥4-fold increase in titers (for example, baseline titer of 10 increasing to ≥40 post-baseline). This is called treatment-boosted ADA."|Baseline through Month 6|All randomized participants who received at least 1 dose of study drug and had evaluable immunogenicity data.|||percentage of participants|||Number
2544560|NCT02959177|Secondary|Number of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)|"C -SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation."|Month 1 through Month 6|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2544561|NCT02959177|Secondary|Number of Participants With Suicidal Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)|"C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thoughts occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal ideation (SI): a yes answer to any of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent"|Month 1 through Month 6|All randomized participants who received at least one dose of study drug and had at least one post baseline C-SSRS assessment.|||Participants|||Count of Participants
2544562|NCT02959177|Secondary|Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)|"The PSMQ-M is a self-rated scale which measures participants level of satisfaction with study medication.The scale has been modified for use in this study, assessing 3 items related to the clinical trial treatment over the past 4 weeks: satisfaction, preference, and side effects. Satisfaction responses range from very unsatisfied to very satisfied with the current treatment. Preference compares the current study medication to previous medications, with responses from much rather prefer my previous medication to much rather prefer the medication administered to me during the study"|Month 6|All randomized participants who received at least one dose of study drug and had Month 6 PSMQ-M measurement.|||percentage of participants|||Number
2544563|NCT02959177|Secondary|Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score|"The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability.~LSMean was calculated using MMRM model with treatment, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors."|Baseline, Month 6|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.|||units on a scale||95% Confidence Interval|Least Squares Mean
2544564|NCT02959177|Secondary|Overall Mean Change From Baseline in Headache Hours|Headache Hours is calculated as the total number of headache hours on which a headache occurred. Overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using the MMRM model with treatment, month, treatment by month, baseline, baseline by month and baseline MHD category.|Baseline, Month 1 through Month 6|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.|||hours per month||95% Confidence Interval|Least Squares Mean
2544565|NCT02959177|Secondary|Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score|"The PGI-S scale is a patient-rated instrument that measures patients own global impression of their illness severity. The patient was instructed as follows: Considering migraine as a chronic condition, how would you rate your level of illness? Response options were from 1 (normal, not at all ill) to 7 (extremely ill). Mean is derived from the average of months 4 to 6 from MMRM model. Least square mean (LSM) was calculated using an MMRM model with treatment, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed effects."|Baseline, Month 4 through Month 6|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.|||units on a scale||95% Confidence Interval|Least Squares Mean
2544635|NCT02957747|Primary|30-day Alcohol Timeline Follow Back|Calendar-assisted measure used to garner a retrospective account of drinking behavior. Scale is in standard alcoholic drinks in an average week in the past month. Higher numbers indicate more drinks per week (i.e., worse outcome).|2 month follow up||||Drinks per week in the past month||Standard Deviation|Mean
2544566|NCT02959177|Secondary|Overall Mean Change From Baseline in Number of Migraine Headache Days With Acute Medication Use|"Migraine Headache Day (MHD) with Acute Medication Use: Calendar days on which migraine or probable migraine occurs, requiring acute medication.~The overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed effects."|Baseline, Month 1 through Month 6|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.|||MDHs with medication use||95% Confidence Interval|Least Squares Mean
2544567|NCT02959177|Secondary|Overall Mean Change From Baseline on the Migraine-Specific Quality (MSQ) of Life Questionnaire|"MSQ version 2.1 is a health status instrument consists of 14 items addressing 3 domains:(1)Role Function-Restrictive (items 1-7);(2)Role Function- Preventive (items 8-11);&(3)Emotional Function (items 12-14).Response options range from none of the time (value 1) to all of the time (value 6), & are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items in that domain. After total raw score is computed for each domain & total score, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement. The overall mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, month, treatment by month, baseline by month and baseline MHD category as fixed factors."|Baseline, Month 4 through Month 6|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.|||units on a scale||95% Confidence Interval|Least Squares Mean
2544568|NCT02959177|Secondary|Percentage of Participants With a 100% Reduction From Baseline in Monthly Migraine Headache Days|Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. A 100% responder in a particular month is any participant who has a 100% reduction from baseline in the monthly number of migraine headache attacks in a 30-day interval. It is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, and baseline MHD category as fixed factors.|Baseline, Month 1 through Month 6|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.|||percentage of participants||Standard Error|Mean
2544569|NCT02959177|Secondary|Percentage of Participants With a 75% or Greater Reduction From Baseline in Monthly Migraine Headache Days|Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. A 75% responder in a particular month is any participant who has a ≥75% reduction from baseline in the monthly number of migraine headache attacks in a 30-day interval. It is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, and baseline MHD category as fixed factors.|Baseline, Month 1 through Month 6|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.|||percentage of participants||Standard Error|Mean
2544570|NCT02959177|Secondary|Percentage of Participants With a 50% or Greater Reduction From Baseline in Monthly Migraine Headache Days|Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. A 50% responder in a particular month is any participant who has a ≥50% reduction from baseline in the monthly number of migraine headache attacks in a 30-day interval. It is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, and baseline MHD category as fixed factors.|Baseline, Month 1 through Month 6|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.|||percentage of participants||Standard Error|Mean
2544571|NCT02959177|Primary|Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD)|"Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.~Migraine Headache : A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B):~A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia; The overall mean is derived from the average of months 1 to 6 from mixed model repeat measures (MMRM) model. Least Square Mean (LSMEAN) was calculated using MMRM models with fixed categorical effects of treatment, month, and treatment-by-month interaction, as well as the continuous, fixed covariates of baseline value and baseline-by-month interaction."|Baseline, Month 1 through Month 6|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.|||Days||95% Confidence Interval|Least Squares Mean
2544572|NCT02959138|Secondary|Percentage of Participants Who Experienced Graded Laboratory Abnormalities|Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. The criteria used for grading was Common Terminology Criteria for Adverse Events (CTCAE) v 4.03.|Day 1 up to Day 31|Participants in the Safety Analysis Set were analyzed. Grouping for the analysis was done based on CLcr.|||percentage of participants|||Number
2544573|NCT02959138|Secondary|Percentage of Participants Who Experienced Treatment-Emergent Adverse Events||Day 1 up to Day 31|The Safety Analysis Set included all enrolled participants who received lanraplenib. Grouping for the analysis was done based on CLcr.|||percentage of participants|||Number
2544588|NCT02958969|Primary|Frequency of Major and Clinically Relevant Non-major Bleeding|"Major and clinically relevant non-major bleeding. Using the ISTH classification, bleeding is defined as major if it is overt and associated with a decrease in the hemoglobin level of 2 g/dL or more, requires the transfusion of 2 or more units of blood, occurs into a critical site, or contributes to death (12).~Using the ISTH classification, clinically relevant nonmajor bleeding is defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, surgical intervention, or interruption of the study drug."|6 months||||Participants|||Count of Participants
2544574|NCT02959138|Primary|PK Parameter: Cmax of Lanraplenib Presented Based on Range of CLcr|"Cmax is defined as the maximum concentration of drug. CLcr was estimated using the CG equation for renal function as recommended by the FDA and international guidance documents. CG equation:~For men: CLcr (mL/min) = ([140-age in years] × [body weight in kg])/(72 × serum creatinine in mg/dL)~For women: CLcr (mL/min) = 0.85 × ([140-age in years] × [body weight in kg])/(72 × serum creatinine in mg/dL)~Participants were classified based on estimated CLcr as:~Moderate renal impairment: CLcr 30-59 mL/min~Severe renal impairment: CLcr 15-29 mL/min~Healthy control: CLcr ≥ 90 mL/min"|0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96 and 120 hours postdose on Day 1|Participants in the PK Analysis Set were analyzed, based on CLcr. Some healthy control participants matched to participants with moderate renal impairment were also used as matches to participants with severe renal impairment.|||ng/mL||Standard Deviation|Mean
2544575|NCT02959138|Primary|PK Parameter: AUCinf of Lanraplenib Presented Based on Range of CLcr|"AUCinf is defined as the concentration of drug extrapolated to infinite time. CLcr was estimated using the CG equation for renal function as recommended by the FDA and international guidance documents. CG equation:~For men: CLcr (mL/min) = ([140-age in years] × [body weight in kg])/(72 × serum creatinine in mg/dL)~For women: CLcr (mL/min) = 0.85 × ([140-age in years] × [body weight in kg])/(72 × serum creatinine in mg/dL)~Participants were classified based on estimated CLcr as:~Moderate renal impairment: CLcr 30-59 mL/min~Severe renal impairment: CLcr 15-29 mL/min~Healthy control: CLcr ≥ 90 mL/min"|0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96 and 120 hours postdose on Day 1|Participants in the PK Analysis Set were analyzed, based on CLcr. Some healthy control participants matched to participants with moderate renal impairment were also used as matches to participants with severe renal impairment.|||h*ng/mL||Standard Deviation|Mean
2544576|NCT02959138|Primary|Pharmacokinetic (PK) Parameter: AUClast of Lanraplenib Presented Based on Range of CLcr|"AUClast is defined as the concentration of drug from time zero to the last observable concentration. CLcr was estimated using the CG equation for renal function as recommended by the FDA and international guidance documents. CG equation:~For men: CLcr (mL/min) = ([140-age in years] × [body weight in kg])/(72 × serum creatinine in mg/dL)~For women: CLcr (mL/min) = 0.85 × ([140-age in years] × [body weight in kg])/(72 × serum creatinine in mg/dL)~Participants were classified based on estimated CLcr as:~Moderate renal impairment: CLcr 30-59 mL/min~Severe renal impairment: CLcr 15-29 mL/min~Healthy control: CLcr ≥ 90 mL/min"|0 (predose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96 and 120 hours postdose on Day 1|PK Analysis Set included all enrolled participants who took study drug, had at least 1 nonmissing postdose concentration value reported by PK lab for corresponding analytes, based on CLcr. Some healthy control participants matched to participants with moderate renal impairment were also used as matches to participants with severe renal impairment.|||h*ng/mL||Standard Deviation|Mean
2544577|NCT02958995|Primary|Hazard Ratio for Risk of 10 Common Cancers Associated With Diabetes|The association between diabetes and risk of each of the 10 most common cancers was assessed by calculating hazard ratio using Cox proportional hazards regression models with control for available potential confounders: age, gender and calendar years. Cox regression techniques was used to examine the association between DM status and cancer risk with adjustment for potential confounding variables in the survey respondent cohort.|15 years|Analysis population included participants from KPNC registry (with or without diabetes) and had completed the MHS in the epidemiology study.|||Ratio||95% Confidence Interval|Number
2544578|NCT02958995|Primary|Age and Sex-Standardized Incidence Rates for the 10 Most Common Cancers Stratified by Diabetes Status|Age and gender adjusted incidence rates, stratified by diabetes status, was calculated using the direct method (2000 US Census as standard), with further stratification on calendar year. Cancer incidence rates were calculated with attention to the proper allocation of at-risk person-time. The association between diabetes and risk of each of the 10 most common cancers was assessed using Cox proportional hazards regression models with control for available potential confounders: age, gender. Similarly, Cox regression technique was used to examine the association between diabetes status and cancer risk among survey responders with adjustment for additional potential confounding variable.|15 years|Analysis population included participants from KPNC registry (with or without diabetes) and had completed the MHS in the epidemiology study.|||Incidence per 100,000 person-years||95% Confidence Interval|Number
2544579|NCT02958982|Secondary|Area Under the Plasma-Concentration|AUC0-t after administration of RP3128/ placebo in part 1 and part 2|Pre-dose through 48 hours post dose||||micrograms*hours/mL||Standard Deviation|Mean
2544580|NCT02958982|Secondary|Cell Count|Absolute and % counts of sputum eosinophils and neutrophils|8 and 24 hours post allergen challenge in Part 3|||||||
2544581|NCT02958982|Secondary|Area Under Effective Concentration (AUEC)|AUEC0-3h, AUEC3-8h after administration of RP3128/ placebo in part 3|0 to 3 hours and 3 to 8 hours post allergen challenge in Part 3|||||||
2544582|NCT02958982|Secondary|Fractional Exhaled Nitric Oxide (FeNo)|Change in FeNo after administration of RP3128/ placebo in part 3|Prechallenge to 3, 8 and 24 hours post challenge in Part 3|||||||
2544583|NCT02958982|Secondary|Measurement of Cytokines|Levels of cytokines following LPS (lipopolysaccharide) or CD3/CD28 stimulation.|Predose and Day 7 in Part 2|||||||
2544584|NCT02958982|Secondary|Peak Plasma Concentration (Cmax)|Cmax after administration of RP3128/ placebo in part 1 and part 2|Pre-dose through 48 hours post dose||||micrograms/mL||Standard Deviation|Mean
2544585|NCT02958982|Primary|Number of Participants With Adverse Events|Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment|Baseline through 2 weeks|There are only two groups: RP3128 and Placebo. Since this is a dose escalation study, the healthy volunteers enrolled in each cohorts are combined together and presented as study drug (RP3128) and Placebo for, the baseline characteristics and outcomes in both SAD and MAD.|||Participants|||Count of Participants
2544586|NCT02958969|Secondary|Frequency of Atherothrombotic Events|6-month rates of myocardial infarction and stroke will be calculated.|6 months||||Participants|||Count of Participants
2544587|NCT02958969|Secondary|Frequency of All-cause Mortality|All-cause mortality at 6 months will be recorded. Cause of death will be classified as related to cancer, myocardial infarction, PE, other cardiovascular or other disease state. Death will be attributed to PE if there is evidence to support an association with PE.|6 months||||Participants|||Count of Participants
2544589|NCT02958969|Primary|Frequency of Symptomatic Venous Thromboembolism|Symptomatic deep vein thrombosis or pulmonary embolism|6 months||||Participants|||Count of Participants
2544590|NCT02958956|Secondary|Number of 10 Most Common Cancer Cases By Dose of Pioglitazone|The 10 most common cancer cases included: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with dose of pioglitazone. The various doses include 1-9000 mg, 9001-25000 mg, 25001-50000 mg and >=50001 mg.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.The unexposed arm was not planned to be analyzed for this outcome measure.|||Cases|||Number
2544591|NCT02958956|Secondary|Hazard Ratio of the 10 Most Common Cancers Associated With Cumulative Dose of Pioglitazone|The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with dose of pioglitazone. The various doses include 1-9000 mg, 9001-25000 mg, 25001-50000 milligram (mg) and greater than or equal to (>=) 50001 mg. Cox proportional hazards regression modeling was used to provide point and interval estimates of the dose. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.|||Ratio||95% Confidence Interval|Number
2544592|NCT02958956|Secondary|Number of 10 Most Common Cancer Cases by Duration of Pioglitazone|The 10 most common cancer cases included: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with duration of pioglitazone. The duration of pioglitazone was categorized as <12 months, 12-23 months, 24-35 months, 36-59 months, 60+ months.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1. The unexposed arm was not planned to be analyzed for this outcome measure.|||Cases|||Number
2544593|NCT02958956|Secondary|Hazard Ratio of the 10 Most Common Cancers Associated With Duration of Pioglitazone|The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with duration of pioglitazone. The duration of pioglitazone was categorized as <12 months, 12-23 months, 24-35 months, 36-59 months, 60+ months. Cox proportional hazards regression modeling was used to provide point and interval estimates of the cumulative duration. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.|||Ratio||95% Confidence Interval|Number
2544594|NCT02958956|Secondary|Number of 10 Most Common Cancers Cases by Time Since First Use of Pioglitazone|Number of 10 most common cancer cases: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with time since first use of pioglitazone. Time since initiation of pioglitazone was categorized as <12 months ago, 12-23 months ago, 24-35 months ago, 36-47 months ago, 48-83 months ago and 84+ months ago.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1. The unexposed arm was not planned to be analyzed for this outcome measure.|||Cases|||Number
2544595|NCT02958956|Secondary|Hazard Ratio of the 10 Most Common Cancers Associated With Time Since First Use of Pioglitazone|The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with time since first use of pioglitazone. The various times since initiation include <12 months ago, 12-23 months ago, 24-35 months ago, 36-47 months ago, 48-83 months ago and 84+ months ago. Cox proportional hazards regression modeling was used to provide point and interval estimates of the time since first use. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.|||Ratio||95% Confidence Interval|Number
2544596|NCT02958956|Primary|Number of 10 Most Common Cancers Associated Cases|Number of 10 most common cancer cases are reported in this measure: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.|||Cases|||Number
2544597|NCT02958956|Primary|Hazard Ratio of the 10 Most Common Cancers Associated With Ever Use of Pioglitazone|The hazard ratio of the 10 most common cancers: prostate, female breast, lung/bronchus, endometrial, colon, non-Hodgkin lymphoma, pancreas, kidney/renal pelvis, rectal, and melanoma associated with ever use of pioglitazone. Cox proportional hazards regression modeling was used to provide point and interval estimates of the relative hazard of the 10 most common cancers associated with ever use of pioglitazone. In all regression analyses, these measures of exposure to pioglitazone were treated as time-dependent covariates and time since entry into the cohort was the time scale.|15 years 5 months|Analysis population included T2DM participants who were identified from the KPNC Diabetes Registry in the study 1.|||Ratio||95% Confidence Interval|Number
2544598|NCT02958826|Primary|Effect of Surgical Sounds on Patient Preference|Prior to leaving the office, immediately after patient has completed Mohs surgical procedure, they will complete the questionnaire asking about their experience with surgical sounds.|Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year.||||percentage of participants|||Number
2544599|NCT02958826|Primary|Effects of Surgical Smoke on Patient Preference|Prior to leaving the office, immediately after patient has completed Mohs surgical procedure, they will complete the questionnaire asking about their experience with surgical smoke.|Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year.|Frequency of participants.|||percentage of participants|||Number
2544600|NCT02958826|Primary|Effect of Surgical Lights on Patient Preference|Prior to leaving the office, immediately after patient has completed Mohs surgical procedure, they will complete the questionnaire asking about their experience with surgical lights.|Questionnaire administered immediately after patient has completed Mohs surgical procedure. Questionnaire response data will be compiled and presented upon completion of the study in approximately one year.||||percentage of participants|||Number
2544601|NCT02958787|Primary|The Percentage of Patients Able to be Sexually Active With or Without the Use of Aids|"The primary endpoint of the study was to accurately determine the preservation of erectile function post radiation therapy. Erectile preservation was defined as a score of 1 or 2 on the three-tier patient reported questionnaire equating to being able to be sexually active with or without aids.~Scoring:~Sexually active without aids~Sexually active with aids~Not sexually active with or without aids"|5 years from end of radiation treatment||||percentage of patients||95% Confidence Interval|Number
2544602|NCT02958553|Other Pre-specified|Activity Diary|Self-Report Diary: Falls and daily activity. This was used to capture daily step counts from the Fitbit, daily activity and adverse events. It was a data collection tool, but was originally named as an Secondary Outcome.|3 months|Daily step counts were collected and reported for Secondary Outcome 12. Any reported falls were collected and reported as Adverse Events. Patient diaries were not collected, and no analysis was possible for other data recorded, such as daily activity.||||||
2544603|NCT02958553|Secondary|Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Pain Intensity Short Form (3a)|PROMIS item banks and their short forms are a reliable and precise measurements of patient reported outcome measures. The scores on the PROMIS instruments with the emPOWER Ankle 3 months after fitting will be compared to the scores on the subject's passive prosthesis. PROMIS Pain Intensity Short Form (3a) improvement was defined as a minimally clinically important difference (MCID) of an increase of 6.9 in a total score.|3 months with the emPOWER ankle|The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in Pain Intensity with the Empower at 3 months compared to Pain Intensity with the subject's passive prosthesis as measured by the Pain Intensity Short Form (3a).|||Participants|||Count of Participants
2544604|NCT02958553|Secondary|Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Fatigue Short Form (7a)|PROMIS item banks and their short forms are a reliable and precise measurements of patient reported outcome measures. The scores on the PROMIS instruments with the emPOWER Ankle 3 months after fitting will be compared to the scores on the subject's passive prosthesis. PROMIS Fatigue Short Form (7a) improvement was defined as a minimally clinically important difference (MCID) of an increase of 5 in a total score.|3 months with the emPOWER ankle|The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in PROMIS Fatigue with the Empower at 3 months compared to PROMIS Fatigue with the subject's passive prosthesis as measured by the PROMIS Fatigue Short Form (7a).|||Participants|||Count of Participants
2544605|NCT02958553|Secondary|Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Global Health Short Form|PROMIS item banks and their short forms are a reliable and precise measurements of patient reported outcome measures. The scores on the PROMIS instruments with the emPOWER Ankle 3 months after fitting will be compared to the scores on the subject's passive prosthesis. PROMIS Global Health Short Form improvement was defined as an increase in a total score of 3.5.|3 months with the emPOWER ankle|The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in PROMIS Global Health with the Empower at 3 months compared to PROMIS Global Health with the subject's passive prosthesis as measured by the PROMIS Global Health Short Form.|||Participants|||Count of Participants
2544606|NCT02958553|Secondary|Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Physical Function|PROMIS item banks and their short forms are a reliable and precise measurements of patient reported outcome measures. The scores on the PROMIS instruments with the emPOWER Ankle 3 months after fitting will be compared to the scores on the subject's passive prosthesis. PROMIS Physical Function improvement was defined as a minimally clinically important difference (MCID) of an increase of 6.8 in a total score.|3 months with the emPOWER ankle|The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in PROMIS Physical Function with the Empower at 3 months compared to PROMIS Physical Function with the subject's passive prosthesis as measured by the PROMIS Physical Function.|||Participants|||Count of Participants
2544607|NCT02958553|Secondary|Number of Participants With Improvement, No Change, or Worsening in Performance in Activity (Monitoring Using a Fitbit Over 2-week Periods)|A Fitbit activity monitor was worn to record the number of steps the Subject took with the prosthesis. The patient returned to the site with the activity monitor and the steps counted were downloaded from the device. In addition, the Subjects were sent home with a prepaid envelope and instructed to mail back the activity monitor if the next visit was more than 3 weeks later, to ensure that the data was not lost. The step counts were downloaded from the device the day the activity monitor was returned to the Investigator. The Investigator recorded the date the patient was affixed with the activity monitor, the date they received the returned activity monitor, and the date they synced the monitor. An improvement was defined as an increase in the average daily step count of 750 steps.|3 months with the emPOWER ankle|The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in activity with the Empower at 3 months compared to the activity with the subject's passive prosthesis as measured by the steps counts from the Fitbit Activity Monitor.|||Participants|||Count of Participants
2544608|NCT02958553|Secondary|Number of Participants With Improvement, No Change, or Worsening in Performance in the Numeric Pain Rating Scale (NPRS)|The NPRS is a valid and reliable measure of pain that may be used across all musculoskeletal injuries/conditions and complements the PSFS. The patient was asked to rate the pain of their joints, foot, lower back, and if they are using an assistive device any additional affected limbs on average over the last 24 hours on a scale 1-10, with '1' being 'very mild' and '10' being the 'unimaginable unspeakable'. The scores on the NPRS instruments with the emPOWER Ankle were compared to the scores on the subject's passive prosthesis. An improvement was considered a positive change of 1 for at least one area without a corresponding decrease in another.|3 months with the emPOWER ankle|The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in NPRS with the Empower at 3 months compared to the NPRS with the subject's passive prosthesis as measured by the NPRS.|||Participants|||Count of Participants
2544629|NCT02957747|Secondary|Effectiveness in Obtaining Resources Scale|"Assesses women's effectiveness in obtaining resources from 11 different types of community resources including church or clergy, health care, legal services, police, or social services. Reporting the subscale for Things I have been successful at. Score range 0-13; higher scores indicate obtaining more resources (i.e., better outcome)."|2 month||||score on a scale||Standard Deviation|Mean
2544609|NCT02958553|Secondary|Number of Participants With Improvement, No Change, or Worsening in Performance in the Patient Specific Functional Scale (PSFS)|"The PSFS is a self-report, goal-attainment measure aimed at identifying functional status limitations that are most relevant to individual patients. The PSFS is a reliable, valid, and efficient measure for detecting clinical change in persons with low back pain and knee dysfunction. Subjects were asked to identify three to five activities that they are having difficulty or are unable to perform because of their injury/condition. For the specified activities, patients were asked to rate their ability to perform each activity at that time (0-10 numerical scale) with '0' being unable to perform the activity, and '10' being able to perform the activity at the same level as they could prior to the injury/condition. The total score was calculated as the sum of the activity scores divided by the number of activities. Changes of >2 in the total score compared to baseline were considered Improved."|3 months with the emPOWER ankle|While 4 subjects completed the PSFS, the results from only one subject were available for analysis, since 3 subjects rated different goals at each time point. The secondary effectiveness endpoint was improvement in PSFS with the Empower at 3 months compared to the PSFS with the subject's passive prosthesis as measured by the PSFS.|||Participants|||Count of Participants
2544610|NCT02958553|Secondary|Number of Participants With Improvement, No Change, or Worsening in Performance in the Prosthetic Limb Users Survey of Mobility PLUS-M (12 Item Short Form)|The PLUS-M is a valid and reliable self-reported measure for the mobility of adults with lower limb amputations. PLUS-M asks about the patient's ability to perform simple and complex tasks. High PLUS-M scores correspond with greater mobility. Improvement in the Mobility PLUS-M (12 item Short Form) was defined by a minimum detectable change of an increase of 5 points in the total score.|3 months with the emPOWER ankle|The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in PLUS-M with the Empower at 3 months compared to the PLUS-M with the subject's passive prosthesis as measured by the PLUS-M measure.|||Participants|||Count of Participants
2544611|NCT02958553|Secondary|Number of Participants With Improvement, No Change, or Worsening in Performance in the Amputee Mobility Predictor (AMP) Assessment|The AMP is an instrument designed to measure ambulatory potential of lower-limb amputees. Subjects begin the test seated in a hard chair with arms and are tested for a total of 21 items assessing abilities of increasing level of difficulty. Abilities assessed include sitting balance, transfer from chair to chair, standing balance, gait quality, negotiating obstacles, and the use of assistive devices. The total score range for the AMP is 0 to 47 points. A minimal detectable change of 4 points was the definition of improvement.|3 months with the emPOWER ankle|The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in AMP with the Empower at 3 months compared to the AMP with the subject's passive prosthesis as measured by the AMP Assessment.|||Participants|||Count of Participants
2544612|NCT02958553|Secondary|Number of Participants With Improvement, No Change, or Worsening in Performance in the Falls Efficacy Scale Score|"The Falls Efficacy Scale is a validated 10-item self-report questionnaire designed to assess confidence in the ability to perform 10 activities of daily living without falling as an indicator of how one's fear of falling impacts physical performance. Each item is rated from 1 (very confident) to 10 (not confident at all), and the per item ratings are added to generate a summary total score (10 to 100). Lower scores indicate more confidence and higher scores indicate lack of confidence and greater fear of falling. It has been validated for use in the elderly and persons with amputations. Scores ≥70 indicate an increased fear of falling. Improvement in the Falls Efficiacy Scale was defined as a minimum increase of 2 in the score."|3 months with the emPOWER ankle|The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in Falls Efficiacy scale with the Empower at 3 months compared to the Falls Efficiacy scale with the subject's passive prosthesis as measured by the Falls Efficiacy scale.|||Participants|||Count of Participants
2544613|NCT02958553|Secondary|Number of Participants With Improvement, No Change, or Worsening in Performance in the Activities-specific Balance Confidence (ABC) Scale Score|"The proportion of patients with a clinically meaningful change (improvement, no change, worsening) in abulatory activities measured by the Activities-specific Balance Confidence Scale. Improvement in the ABC was defined as a minimum detectable change of 13% increase in score.~The ABC Scale is a self-administered questionnaire that asks the patient to rate his or her confidence in performing various ambulatory activities on a scale from 0% (no confidence) to 100% (complete confidence) without losing balance or becoming unsteady. Scores for each of the 16 items will be collected and an average percentage calculated, with scores <67 indicating an increased risk of falling."|3 months with the emPOWER ankle|The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in ABC scale with the Empower at 3 months compared to the ABC scale with the subject's passive prosthesis as measured by the ABC scale.|||Participants|||Count of Participants
2544614|NCT02958553|Secondary|Number of Participants With Improvement, No Change, or Worsening in Performance in the Ramp Test|The proportion of patients with a clinically meaningful change (improvement, no change, worsening) in the walking time measured in theRamp Test. Ramp Test improvement was defined as a minimum decrease of 6 seconds to complete the test.|3 months with the emPOWER ankle|The results for the secondary effectiveness endpoint for improvement in walking distance with the Empower compared to the distance walked with the subject's passive prosthesis as measured by the Ramp Test at 3 months from four subjects were available for analysis.|||Participants|||Count of Participants
2544615|NCT02958553|Secondary|Number of Participants With Improvement, No Change, or Worsening in Performance in the L-Test|The proportion of patients with a clinically meaningful change (improvement, no change, worsening) in the walking time measured in the L-Test. L-Test improvement was defined as a minimum decrease of 4.5 seconds.|3 months with the emPOWER ankle|The results for the secondary effectiveness endpoint for improvement in walking distance with the Empower compared to the distance walked with the subject's passive prosthesis as measured by the L-Test at 3 months from four subjects were available for analysis.|||Participants|||Count of Participants
2544630|NCT02957747|Primary|PCL-5|Symptoms of PTSD. Score range 0-80; higher scores indicate more PTSD symptoms (i.e., worse outcome).|4 month follow-up||||score on a scale||Standard Deviation|Mean
2544631|NCT02957747|Primary|Composite Abuse Scale|30 item measure of chronicity and occurrence of intimate partner violence with current partner in past 12 months. Score range from 0-150; higher scores indicate more intimate partner violence (i.e., worse outcome).|4 month follow-up||||score on a scale||Standard Deviation|Mean
2544616|NCT02958553|Secondary|Number of Participants With Improvement, No Change, or Worsening in Performance in the 10 Meter Walk Test (10MWT)|The proportion of patients with a clinically meaningful change (improvement, no change, worsening) in the walking distance measured by the 10 Meter Walk Test (10MWT). 10MWT improvement was defined as a minimum increase of 0.1 m/s.|3 months with the emPOWER ankle|The results for the secondary effectiveness endpoint for improvement in walking distance with the Empower compared to the distance walked with the subject's passive prosthesis as measured by the 10MWT at 3 months from four subjects were available for analysis.|||Participants|||Count of Participants
2544617|NCT02958553|Secondary|Number of Participants With Improvement, No Change, or Worsening in Performance in the Twelve Minute Walk Test (12MWT)|The proportion of patients with a clinically meaningful change (improvement, no change, worsening) in the walking distance measured by the Twelve Minute Walk Test (12MWT). 12minWT improvement was defined as a minimum increase of 90 meters.|3 months with the emPOWER ankle|The results for the secondary effectiveness endpoint for improvement in walking time with the Empower compared to the distance walked with the subject's passive prosthesis as measured by the 12 minute Walk Test (12MWT) at 3 months from four subjects were available for analysis.|||Participants|||Count of Participants
2544618|NCT02958553|Primary|Number of Participants With Improvement, No Change, or Worsening in Performance in the Six Minute Walk Test (6MWT)|The proportion of patients with a clinically meaningful change (improvement, no change, worsening) in the walking distance measured by the Six Minute Walk Test (6MWT). 6minWT improvement was defined as a minimum increase of 45 meters.|3 months with the emPOWER ankle|The results for the primary effectiveness endpoint for improvement in walking distance with the Empower compared to the distance walked with the subject’s passive prosthesis as measured by the 6 minute Walk Test (6MWT) at 3 months from four subjects were available for analysis.|||Participants|||Count of Participants
2544619|NCT02958345|Secondary|GPELISA, VZV Glycoprotein Enzyme-Linked Immunosorbent Assay (Aka Varicella Zoster Antibody Titre)|Change in pre and post vaccination Varicella Zoster Virus|Day 1 and 6 weeks|Data was not available for analysis due to laboratory processing error.||||||
2544620|NCT02958345|Primary|ELISPOT, Interferon-G Enzyme-Linked Immunospot Assay|Change in vitro cell-mediated immune response to varicella virus before and after vaccination in subjects receiving Zostavax™ versus those receiving placebo.|Day 1 and 6 weeks|Data was not available for analysis due to laboratory processing error.||||||
2544621|NCT02958267|Secondary|Patient Reported Outcome Measurement Information System Global Health Scores|"The Patient Reported Outcomes Measurement Information System (PROMIS®) Global Health scale v1.1 contains 10 questions and produces two subscale scores: Global Physical Health (GPH) and Global Mental Health (GMH) (Hays, Bjorner, Revicki, Spritzer, & Cella, 2009). Each subscale produces a raw score that is converted to a T score such that an average patient in the United States would have a subscale T score of 50 with a standard deviation of 10 points (Global Health: A Brief Guide to the PROMIS® Global Health Instruments, 2017). A score higher than the mean indicates a more desirable score, and vice versa. A positive change score indicates an improvement, while a negative change score indicates a decline in score value."|Change from baseline to 3, 6, and 12 months post-treatment|One participant in the BMAC injection and PRP injection group withdrew prior to the 6 month follow-up and another prior to the 12 month follow-up both due to the pursuit of an additional treatment option. One participant in the hyaluronate injection group withdrew prior to the 6 month follow-up due to pursuit of an additional treatment option.|||score on a scale||95% Confidence Interval|Mean
2544622|NCT02958267|Secondary|Numeric Pain Rating Scale|"Scale from 0-10 with 0 representing no pain and 10 representing worst imaginable pain"|Change from baseline to 3, 6, and 12 months post-treatment|One participant in the BMAC injection and PRP injection group withdrew prior to the 6 month follow-up and another prior to the 12 month follow-up both due to the pursuit of an additional treatment option. One participant in the hyaluronate injection group withdrew prior to the 6 month follow-up due to pursuit of an additional treatment option.|||score on a scale||95% Confidence Interval|Mean
2544623|NCT02958267|Primary|Knee Injury and Osteoarthritis Outcome Score|Subscales include pain, symptoms, function in activities of daily living, function in sport and recreation, and knee-related quality of life. Each subscale is 0-100 with 100 indicating the best possible score.|Change from baseline to 3, 6, and 12 months post-treatment|One participant in the BMAC injection and PRP injection group withdrew prior to the 6 month follow-up and another prior to the 12 month follow-up both due to the pursuit of an additional treatment option. One participant in the hyaluronate injection group withdrew prior to the 6 month follow-up due to pursuit of an additional treatment option.|||score on a scale||95% Confidence Interval|Mean
2544624|NCT02957747|Other Pre-specified|The Client Satisfaction Questionnaire|8-item questionnaire which assesses the participant's satisfaction with the intervention. Score range 4-32; higher scores indicate higher satisfaction with the intervention (i.e., better outcome).|time zero (completed immediately after participant receives intervention session)||||score on a scale||Standard Deviation|Mean
2544625|NCT02957747|Other Pre-specified|Satisfaction With CIAS Software Scale|Assesses participant satisfaction with the computerized software with items on likeability, ease of use, level of interest, and respectfulness. Score range is 7-35; higher numbers indicate higher satisfaction with the software (i.e., better outcome).|time zero (completed immediately after participant receives intervention session)||||score on a scale||Standard Deviation|Mean
2544626|NCT02957747|Secondary|Adapted Treatment Services Review|Self-report utilization of mental health and substance abuse treatment. Range is open, as measure assesses women's self-report of treatment appointments. Higher scores indicate a greater number of treatment appointments and thus greater use of treatment (i.e., better outcome).|4 month||||score on a scale||Standard Deviation|Mean
2544627|NCT02957747|Secondary|Effectiveness in Obtaining Resources Scale|"Assesses women's effectiveness in obtaining resources from 11 different types of community resources including church or clergy, health care, legal services, police, or social services. Reporting the subscale for Things I have been successful at. Score range 0-13; higher scores indicate obtaining more resources (i.e., better outcome)."|4 month||||score on a scale||Standard Deviation|Mean
2544628|NCT02957747|Secondary|Adapted Treatment Services Review|Self-report utilization of mental health and substance abuse treatment. Range is open, as measure assesses women's self-report of treatment appointments. Higher scores indicate a greater number of treatment appointments and thus greater use of treatment (i.e., better outcome).|2 month||||score on a scale||Standard Deviation|Mean
2544636|NCT02956967|Other Pre-specified|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.|Baseline up to 6 months|Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.|||Participants|||Count of Participants
2544637|NCT02956967|Secondary|Percentage of Participants With Febrile Neutropenia|Grade 3/4 febrile neutropenia is defined as a temperature of greater than or equal to (>=) 38.0 degree Celsius and absolute neutrophil count of less than (<) 1.0 × 10^9 Neutrophils per Liter.|Baseline up to 6 months|Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.|||percentage of participants|||Number
2544638|NCT02956967|Secondary|Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count||Cycle 1, 2, 3, 4, 5, 6|Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, n signifies those participants who were evaluable at specified time points only.|||days||Full Range|Median
2544639|NCT02956967|Secondary|Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count||Cycle 1, 2, 3, 4, 5, 6|Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, n signifies those participants who were evaluable at specified time points only.|||10^9 Neutrophils per Liter||Standard Deviation|Mean
2544640|NCT02956967|Secondary|Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle||End of study visit of Cycle 1, 2, 3, 4, 5, 6 (maximum up to Month 6)|Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, n signifies those participants who were evaluable at specified time points only.|||10^9 Neutrophils per Liter||Standard Deviation|Mean
2544641|NCT02956967|Secondary|Minimum Value of Absolute Neutrophil Count||Cycle 1, 2, 3, 4, 5, 6|Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, n signifies those participants who were evaluable at specified time points only.|||10^9 Neutrophils per Liter||Standard Deviation|Mean
2544642|NCT02956967|Secondary|Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6||Baseline, Cycle 1, 2, 3, 4, 5, 6|Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, number analyzed (n) signifies those participants who were evaluable at specified time points only.|||10^9 Neutrophils per Liter||Standard Deviation|Mean
2544643|NCT02956967|Secondary|Percentage of Participants With at Least One Infection and Serious Infection|Infections included bronchitis, upper respiratory tract infection, cystitis, herpes virus infection, influenza, lung infection, oral candidiasis, skin infection and vulvovaginal mycotic infection. Serious Infections included serious adverse events resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 6 months|Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.|||percentage of participants|||Number
2544644|NCT02956967|Secondary|Percentage of Participants With Neutropenia|Percentage of participants with absolute neutrophil count (greater than)>0.5*10^9 Neutrophils per Liter were reported in this outcome measure.|Baseline up to 6 months|Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.|||percentage of participants|||Number
2544645|NCT02956967|Secondary|Participant's Assessment of Overall Tolerability of Subcutaneous Injection|Participants evaluated the overall tolerability of subcutaneous injection of treatment as part of a questionnaire. The tolerability was rated under the 5 categories as: Very good, good, satisfactory, did not tolerate well, did not tolerate at all. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For this outcome measure, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category in this summary.|Baseline up to 6 months|Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2544646|NCT02956967|Secondary|Participant's Assessment of Injection Site Pain and Tolerability|Participants evaluated the injection site pain and the injection site tolerability of the treatment as part of a questionnaire. The injection site pain was rated under the 5 available categories as: Did not feel anything, did not feel much, light stitch, painful and very painful. Injection site tolerability was also rated under the 5 available categories as: Very good, good, satisfactory, did not tolerate well, did not tolerate at all.The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For both the injection site pain and tolerability, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category for each of them.|Baseline up to 6 months|Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2544660|NCT02956837|Secondary|Neutralizing Antibody Titers Against RSV-A Subtype|RSV-A is one of the two antigenically distinct subgroups of the Respiratory Synctial Virus (RSV). Antibody titers were determined by neutralization assay and presented as geometric mean titers (GMTs), for a seropositivity cut-off value ≥ 8 ED60.|At Day 60 and Day 90|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 90, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay up to Day 90.|||Titers||95% Confidence Interval|Geometric Mean
2544647|NCT02956967|Secondary|Participant's Assessment for Nivestim Packaging|Participants evaluated the packaging of Nivestim as part of a questionnaire. The packaging was rated under the 2 available categories as either easy or complicated. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For this outcome measure, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category in this summary.|Baseline up to 6 months|Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2544648|NCT02956967|Secondary|Participants' Overall Satisfaction Scores in Response to the Study Treatment|Participants rated the overall satisfaction with Nivestim as part of a questionnaire. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. The satisfaction was rated on a scale ranging from 1 (minimum score) to 6 (maximum score), where higher scores indicated dissatisfaction with the treatment. For this outcome measure, the within-participant average scores are summarized.|Baseline up to 6 months|Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N signifies those participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2544649|NCT02956967|Primary|Percentage of Participants With Response to Study Treatment||Baseline up to 6 months|The data for this outcome measure was not collected as it was not planned to be analyzed as prespecified in protocol.||||||
2544650|NCT02956967|Primary|Duration of Different Types of Chemotherapies Received by Participants During Study||Baseline up to 6 months|The data for this outcome measure was not collected as it was not planned to be analyzed as prespecified in protocol.||||||
2544651|NCT02956967|Primary|Number of Participants Who Received Chemotherapy Prior to Enrolment in Study||Baseline (Day 1)|Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.|||participants|||Number
2544652|NCT02956967|Primary|Duration of Solid Tumour in Participants Prior to Enrolment in Study|Time from diagnosis of any previous solid tumour in participants up to the enrolment in the study was recorded at baseline and reported in this outcome measure.|Baseline (Day 1)|Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N (Number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||years||Standard Deviation|Mean
2544653|NCT02956967|Primary|Percentage of Participants With Different Types of Solid Tumour|Different types of solid tumour included tumour of a) Digestive organs such as colon, oesophagus, pancreas, stomach tumour b) Gynaecological organs such as breast, endometrium, ovaries tumour c) Lung organs such as non-small cell lung cancer and small cell lung cancer d) Urological organs such as bladder, prostate gland, testicles tumour e) other organ tumours. Percentage of participants with different types of ongoing solid tumour were reported in this outcome measure.|Baseline (Day 1)|Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.|||percentage of participants|||Number
2544654|NCT02956967|Primary|Percentage of Participants With Different Types of Haematological Malignancies|Different types of Haematological malignancies included Hodgkin's lymphoma, leukemia (chronic lymphocytic leukemia), non-Hodgkin's lymphoma and other stem cell transformations. Percentage of participants with different type of ongoing haematological malignancies were reported in this outcome measure.|Baseline (Day 1)|Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.|||percentage of participants|||Number
2544655|NCT02956967|Primary|Percentage of Participants With Any Significant Comorbidities|Comorbidities included ongoing cardiovascular diseases, liver failure, psychological disorders, respiratory disease, viral infections and other infections (respiratory tract, systemic, uro-genital). Percentage of participants with any ongoing comorbidities were reported in this outcome measure.|Baseline (Day 1)|Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.|||percentage of participants|||Number
2544656|NCT02956837|Secondary|Number of Subjects With Any Medically Attended (MA) Respiratory Tract Infections (RTIs) Associated With RSV|MA-RSV-RTIs were defined as a visit to a health care provider for respiratory symptoms including but not limited to cough, sputum production, difficulty breathing.|From Day 0 up to study end, at Day 360|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2544657|NCT02956837|Secondary|Antibody Concentrations Against Neogenin (NEO) Residual Host Cell Protein|Anti-neogenin (anti-NEO) antibody concentrations were determined by ELISA, presented as geometric mean concentrations (GMCs) and expressed in nanograms per milliliter (ng/mL), for a seropositivity cut-off value ≥ 55 ng/mL.|At Day 0 and Day 30|This immunogenicity analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom immunogenicity results were available for this assay up to Day 30.|||ng/mL||95% Confidence Interval|Geometric Mean
2544658|NCT02956837|Secondary|Palivizumab Competing Antibody (PCA) Concentrations|PCA concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL), for a seropositivity cut-off value ≥ 9.6 µg/mL.|At Day 60 and Day 90|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 90, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay up to Day 90.|||µg/mL||95% Confidence Interval|Geometric Mean
2544659|NCT02956837|Secondary|Neutralizing Antibody Titers Against RSV-B Subtype|RSV-B is one of the two antigenically distinct subgroups of the Respiratory Synctial Virus (RSV). Antibody titers were determined by neutralization assay and presented as geometric mean titers (GMTs), for a seropositivity cut-off value ≥ 6 ED60.|At Day 0, Day 30, Day 60 and Day 90|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 90, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay up to Day 90.|||Titers||95% Confidence Interval|Geometric Mean
2544661|NCT02956837|Secondary|Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities, by Maximum Grading|The biochemical and hematological parameters analyzed were ALT, AST, creatinine, eosinophils increase, hemoglobin decrease, lymphocytes decrease, neutrophils decrease, platelet count decrease, WBC decrease and WBC increase, which were graded by FDA Toxicity Grading Scale. Assessed grades over the Day 7- Day 90 period were Unknown, Grade 0 (=no grade), Grade 1 (=mild), Grade 2 (=moderate), Grade 3 (=severe) and Grade 4 (=potentially life-threatening), as compared to the baseline status of the same parameters, at Day 0 (Unknown, Grade 1, Grade 2, Grade 3) [e.g. ALT Grade 0 - Unknown = ALT Grade 0 at baseline versus Unknown grade from Day 7 up to Day 90].|From Day 7 up to Day 90|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with available results for each parameter analyzed, during the considered period.|||Participants|||Count of Participants
2544662|NCT02956837|Secondary|Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities|Biochemical parameters assessed included alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine. Hematological parameters assessed included eosinophils, hemoglobin level, lymphocytes, neutrophils, platelet count and White Blood Cells [WBC]. Abnormal laboratory values at Day 90 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) [e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 90].|At Day 90|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 90.|||Participants|||Count of Participants
2544663|NCT02956837|Secondary|Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities|Biochemical parameters assessed included alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine. Hematological parameters assessed included eosinophils, hemoglobin level, lymphocytes, neutrophils, platelet count and White Blood Cells [WBC]. Abnormal laboratory values at Day 60 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) [e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 60].|At Day 60|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 60.|||Participants|||Count of Participants
2544664|NCT02956837|Secondary|Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities|Biochemical parameters assessed included alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine. Hematological parameters assessed included eosinophils, hemoglobin level, lymphocytes, neutrophils, platelet count and White Blood Cells [WBC]. Abnormal laboratory values at Day 30 were Below, Within and Above normal ranges, as compared to the baseline values of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) [e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 30].|At Day 30|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 30.|||Participants|||Count of Participants
2544665|NCT02956837|Secondary|Number of Subjects With Any Biochemical and Hematological Laboratory Abnormalities|Biochemical parameters assessed included alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine. Hematological parameters assessed included eosinophils, hemoglobin level, lymphocytes, neutrophils, platelet count and White Blood Cells [WBC]. Abnormal laboratory values at Day 7 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) [e.g. ALT Below - Within = ALT with below normal value at baseline and within normal values at Day 7].|At Day 7|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with available results for each parameter analyzed, at Day 7.|||Participants|||Count of Participants
2544666|NCT02956837|Secondary|Number of Subjects With Any SAEs|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 up to study end, at Day 360|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2544667|NCT02956837|Secondary|Number of Subjects With Any Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2544668|NCT02956837|Secondary|Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (which include nausea, vomiting, diarrhoea and/or abdominal pain), headache, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 2 symptoms = occurrence of symptoms discomforting enough to interfere with daily activities. Grade 3 symptoms = symptoms that prevented normal activities.Related = symptom assessed by the investigator as related to the vaccination. Medically attended symptom = occurrence of symptom that required medical advice.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptom sheets filled in.|||Participants|||Count of Participants
2544669|NCT02956837|Secondary|Number of Subjects With Any, Grade 2, Grade 3 and Medically Attended Solicited Local AEs|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 2 pain = painful when limb was moved and that interfered with every day activities.Grade 3 pain = significant pain at rest, pain that prevented normal every day activity. Grade 2 redness/swelling = redness/swelling spreading beyond (>) 50 millimeters (mm) and up to (and including) 100 mm of injection site.Grade 3 redness/swelling = redness/swelling > 100 mm of injection site. Medically attended symptoms = occurrence of symptoms that required medical advice.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptom sheets filled in.|||Participants|||Count of Participants
2544670|NCT02956837|Primary|Pavilizumab Competing Antibody (PCA) Concentrations|PCA concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL), for a seropositivity cut-off ≥ 9.6 µg/mL. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).|At Day 30|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 30, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay at Day 30.|||µg/mL||95% Confidence Interval|Geometric Mean
2544671|NCT02956837|Primary|Palivizumab Competing Antibody (PCA) Concentrations|PCA concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL), for a seropositivity cut-off ≥ 9.6 µg/mL. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).|At Day 0|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 30, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay at Day 0.|||µg/mL||95% Confidence Interval|Geometric Mean
2544672|NCT02956837|Primary|Neutralizing Antibody Titers Against RSV-A Subtype|RSV-A is one of the two antigenically distinct subgroups of the Respiratory Synctial Virus (RSV). Antibody titers were determined by neutralization assay and presented as geometric mean titers (GMTs), for a seropositivity cut-off value ≥ 8 ED60 (Estimated Dilution 60). This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).|At Day 30|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 30, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay at Day 30.|||Titers||95% Confidence Interval|Geometric Mean
2544673|NCT02956837|Primary|Neutralizing Antibody Titers Against RSV-A Subtype|RSV-A is one of the two antigenically distinct subgroups of the Respiratory Synctial Virus (RSV). Antibody titers were determined by neutralization assay and presented as geometric mean titers (GMTs), for a seropositivity cut-off value greater than or equal to (≥) 8 ED60 (Estimated Dilution 60). This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).|At Day 0|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 30, which included all evaluable subjects who complied with the post-vaccination blood sampling schedule and for whom post-vaccination immunogenicity results were available for this assay at Day 0.|||Titers||95% Confidence Interval|Geometric Mean
2544674|NCT02956837|Primary|Number of Subjects With Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAEs = SAEs assessed by the investigator as related to the vaccination. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2544675|NCT02956837|Primary|Number of Subjects With Grade 2 and Grade 3 Fever|Grade 2 Fever was defined as oral temperature above (>) 38.5 degrees Celsius (°C) to less than or equal to (≤) 39.5°C. Grade 3 Fever was defined as oral temperature > 39.5°C. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who had their symptom sheets filled in.|||Participants|||Count of Participants
2544676|NCT02956837|Primary|Number of Subjects With Any Grade 2 and Grade 3 General Adverse Events (AEs) - Solicited and Unsolicited|Assessed solicited general AEs were fatigue, gastrointestinal symptoms [nausea, vomiting, diarrhea and/or abdominal pain], fever and headache. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.Grade 2 symptoms = occurrence of symptoms discomforting enough to interfere with daily activities. Grade 3 symptoms = symptoms that prevented normal activities. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.|||Participants|||Count of Participants
2544677|NCT02956746|Secondary|Serum Half Lives of CTB011 and CTB012|The time in hours to reduce the serum concnetration of CTB011 and CTB012 to 50% of the maximum serum concentration at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis.|84 days|Per-Protocol Population (subjects who received all scheduled doses of a study treatment and remained on study for at least 28 days without major protocol violation). No detectable and quantifiable levels of CTB011 and CTB012 were observed in human rabies immune globulin groups, so no PK or statistical analysis was planned.|||day||Standard Deviation|Mean
2544678|NCT02956746|Secondary|Serum Clearance Rate (Clp) of CTB011 and CTB012|Calculated serum clearance rates for CTB011 and CTB012 at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis.|84 days|Per-Protocol Population (subjects who received all scheduled doses of a study treatment and remained on study for at least 28 days without major protocol violation). No detectable and quantifiable levels of CTB011 and CTB012 were observed in human rabies immune globulin groups, so no PK or statistical analysis was planned.|||L/day||Standard Deviation|Mean
2544679|NCT02956746|Secondary|Maximum Serum Concentration Cmax|Maximum concentration of of CTB011 and CTB012 at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis.|84 days|Per-Protocol Population (subjects who received all scheduled doses of a study treatment and remained on study for at least 28 days without major protocol violation). No detectable and quantifiable levels of CTB011 and CTB012 were observed in human rabies immune globulin groups, so no PK or statistical analysis was planned.|||ng/mL||Standard Deviation|Mean
2544680|NCT02956746|Secondary|Time to Maximum Concentration Tmax of CTB011 and CTB012|Interval from time 0 to maximum measured concentration of CTB011 and CTB012 (SYN023 components) at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis.|84 days|Per-Protocol Population (subjects who received all scheduled doses of a study treatment and remained on study for at least 28 days without major protocol violation). No detectable and quantifiable levels of CTB011 and CTB012 were observed in human rabies immune globulin groups, so no PK or statistical analysis was planned.|||day||Standard Deviation|Mean
2544681|NCT02956746|Secondary|SYN023 Monoclonal Antibody Areas Under the Curve (AUC0-last, AUC0-inf) for CTB011 and CTB012)|The area under the time concentration curve for SYN023 mAb components CTB011 and CTB012 will be estimated at Day 0 ( pre-dose), Day 1, Day 3, Day 7, Day 14, Day 28, Day 35, Day 42, and Day 84 post-dose, using non compartmental analysis.|84 days|Per-Protocol Population (subjects who received all scheduled doses of a study treatment and remained on study for at least 28 days without major protocol violation)|||day*ng/mL||Standard Deviation|Mean
2544682|NCT02956746|Secondary|Percentage of Participants With Immunogenicity: Anti-CTB011 Antibodies Positive|Measurement of the development of anti-CTB011 antibodies (a component of anti-SYN023 antibodies) in participants which will be analyzed on a continuous scale as a categorical variable by treatment assignment, with descriptive statistics.|112 days|Subjects at least 1 initial anti-SYN023 assay results|||percentage of subjects|||Number
2544683|NCT02956746|Secondary|Percentage of Participants With Immunogenicity: Anti-CTB012 Antibodies Positive|Measurement of the development of anti-CTB012 antibodies (a component of anti-SYN023 antibodies) in participants which will be analyzed on a continuous scale as a categorical variable by treatment assignment, with descriptive statistics.|112 days|Subjects at least 1 initial anti-SYN023 assay results|||percentage of participants|||Number
2544684|NCT02956746|Secondary|Percentage of Participants With Adverse Event Incidence of SYN023 Compared to HRIG in RabAvert and Imovax Reciptients|Electrocardiograms are performed to monitor subject safety. Laboratory evaluations for subject safety (adverse events) are serum chemistry evaluations, blood urea nitrogen, creatinine, bilirubin, alanine amino transferase, aspartate amino transferase, creatine phosphokinase, troponin, potassium, sodium, bicarbonate, calcium, complete blood count, platelet count, differential count, PT(prothrombin time, international normalized ratio) and PTT (partial prothrombin time and urinalyses for monitoring of safety. Additional laboratory tests may be required for evaluation of specific adverse events such as anaphylaxis and immune complex diseases. Adverse events and serious adverse events will be analyzed. A comparison of adverse event incidence between the four treatment groups will be performed.|42 days||||percentage of participants|||Number
2544685|NCT02956746|Primary|Percentage of Participants With Serum Rabies Virus Neutralizing Activity|Inhibitory activity of serum in standard rabies virus inhibition test (RFFIT: Rapid Fluorescent Foci Inhibition Test) assessed as serum RVNA ≥ 0.5 IU/mL. RFFIT is a serum neutralization (inhibition) test, which means it measures the ability of rabies specific antibodies to neutralize rabies virus and prevent the virus from infecting cells. These antibodies are called rabies virus neutralizing antibodies (RVNA).|112 days|Per-Protocol Population (subject with complete RVNA data).|||percentage of participants|||Number
2544686|NCT02956629|Secondary|Percentage of Participants With Virologic Failure|Virologic failure is the detection of HCV RNA among participants who do not discontinue study for non-treatment-related reasons, either due to on-treatment failure defined as either non-response where HCV RNA is detected at end of treatment without HCV RNA <LLOQ having been achieved while on treatment; rebound defined as >1 log10 IU/mL increase in HCV RNA from nadir while on treatment and confirmed from a separate blood draw within 2 weeks; or virologic breakthrough which is confirmed HCV RNA ≥LLOQ (target detected, quantifiable [TD(q)]) after being <LLOQ previously while on treatment. Confirmation is defined as an HCV RNA ≥LLOQ from a separate blood draw repeated within 2 weeks; or relapse post-treatment. where there is a confirmed HCV RNA ≥LLOQ [TD(q)] following end of all study therapy, after becoming undetectable (target not detected [TND]) at end of treatment. Confirmation is defined as an HCV RNA ≥LLOQ from a separate blood draw repeated within 2 weeks.|Up to Week 24|Participants who followed the protocol sufficiently to allow the analysis of the results. Participants who deviated substantially from the protocol were excluded.|||Percentage of participants|||Number
2544687|NCT02956629|Secondary|Percentage of Participants With SVR 24 Weeks After Completing Study Therapy (SVR24)|Plasma levels of HCV RNA) were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from participants. SVR24 is the absence of detectable RNA of the hepatitis C virus (<LLOQ of 15 IU/mL), for at least 24 weeks after completing treatment.|24 weeks after completing study therapy (Week 36)|All participants who were assigned to treatment, and received at least one dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
2544688|NCT02956629|Primary|Percentage of Participants Discontinuing Study Therapy Due to an AE|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example ), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to Week 12|All participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2544707|NCT02956460|Primary|Vision Quality|Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear|2 weeks||||units on a scale||Standard Deviation|Mean
2544708|NCT02956460|Primary|Overall Dryness|Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness|2 weeks||||units on a scale||Standard Deviation|Mean
2544689|NCT02956629|Primary|Percentage of Participants Experiencing a Drug-related SAE|A SAE is any AE occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is an other important medical event; is a cancer; is associated with an overdose. A drug-related SAE is determined by the investigator to be related to the use of the drug.|Up to Week 14|All participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2544690|NCT02956629|Primary|Percentage of Participants Experiencing a Drug-related AE|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example ), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE is determined by the investigator to be related to the use of the drug.|Up to Week 14|All participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2544691|NCT02956629|Primary|Percentage of Participants Experiencing a Serious Adverse Event (SAE)|A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is an other important medical event; is a cancer; is associated with an overdose.|Up to Week 14|All participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2544692|NCT02956629|Primary|Percentage of Participants Experiencing an AE of Clinical Importance (ECI)|Adverse events of clinical importance, excluding overdoses include, but is not limited to, significant changes in alanine aminotransferase, aspartate aminotransferase, blood creatinine, glomerular filtration rate or hepatitis B reactivation.|Up to Week 14|All participants who received at least one dose of study treatment|||Percentage of participants|||Number
2544693|NCT02956629|Primary|Percentage of Participants Experiencing an Adverse Event (AE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example ), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change infrequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to Week 14|All participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2544694|NCT02956629|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Completing Study Therapy (SVR12)|Plasma levels of hepatitis C virus (HCV) ribonucleic acid (RNA) were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from participants. SVR12 is the absence of detectable RNA of the hepatitis C virus, (<lower limit of quantification [LLOQ] of 15 IU/mL) for at least 12 weeks after completing treatment.|12 weeks after completing study therapy (Week 24)|All participants who were assigned to treatment, and received at least one dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
2544695|NCT02956616|Secondary|Postoperative Length of Hospital Stay|Postoperative Length of Hospital Stay in Hours from time of surgery|Until patient's day of hospital discharge or a maximum of one month from cesarean delivery||||Hours||Inter-Quartile Range|Median
2544696|NCT02956616|Secondary|Breastfeeding Initiation|All patients will be queried regarding whether breastfeeding was initiated after cesarean birth and how soon after birth|Until patient's day of hospital discharge or a maximum of one month from cesarean delivery||||Participants|||Count of Participants
2544697|NCT02956616|Secondary|Postoperative Pain Medication Requirement|The amount of postoperative pain medication required for each patient in Morphine Milligram Equivalents|Until patient's day of hospital discharge or a maximum of one month from cesarean delivery||||Morphine Milligram Equivalents||Standard Deviation|Mean
2544698|NCT02956616|Primary|Discharge on Postoperative Day #2|Number of patients discharged on postoperative Day #2|Until patient's day of hospital discharge or a maximum of one month from cesarean delivery||||Participants|||Count of Participants
2544699|NCT02956460|Primary|Lens Wettability|Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable|2 weeks||||units on a scale||Standard Deviation|Mean
2544700|NCT02956460|Primary|Lens Hydrated|Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated|2 weeks||||units on a scale||Standard Deviation|Mean
2544701|NCT02956460|Primary|Clean Feeling|Subjective ratings for lens clean feeling is assessed on a scale 0-10, 0=not clean at all, 10=lenses feel perfectly clean|2 weeks||||units on a scale||Standard Deviation|Mean
2544702|NCT02956460|Primary|Smoothness|Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth|2 weeks||||units on a scale||Standard Deviation|Mean
2544703|NCT02956460|Primary|Conjunctival Staining|"Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification.~0=None, no staining present~Very slight~Slight~Moderate~Severe"|2 weeks||||units on a scale||Standard Deviation|Mean
2544704|NCT02956460|Primary|Lens Centration|Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable).|2 weeks||||Participants|||Count of Participants
2544705|NCT02956460|Primary|Vision Satisfaction|Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied.|2 weeks||||units on a scale||Standard Deviation|Mean
2544706|NCT02956460|Primary|Lens Handling|Subjective ratings of lens handling - insertion and removal - is assessed using scale 0-10, 0=difficult to handle, 10=very easy to handle|2 weeks||||units on a scale||Standard Deviation|Mean
2544710|NCT02956122|Secondary|Trough Plasma Concentration at Steady State (Ctrough) of GLASSIA|Ctrough of GLASSIA was not assessed due to the termination of the study.|Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours|PK Analysis set included all participants in the SAF set who have at least 1 PK or stool sample collected. Here, number of participants analyzed refer to the participants evaluable for this outcome at specified time point.||||||
2544711|NCT02956122|Secondary|Mean Residence Time (MRT) of GLASSIA|MRT of GLASSIA was not calculated.|Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours|PK Analysis set included all participants in the SAF set who have at least 1 PK or stool sample collected. Her, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point.||||||
2544712|NCT02956122|Secondary|Apparent Terminal Half-life (t1/2) of GLASSIA|Apparent terminal half-life (hour), determined as ln2/lambda-z. lambda-z is the apparent terminal rate constant (one per hour), determined by linear regression of the terminal points of the log-linear concentration-time curve. Visual assessment will be used to identify the terminal linear phase of the concentration-time profile. A minimum of 3 data points will be used for determination. t1/2 of GLASSIA was reported.|Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours|PK Analysis set included all participants in the SAF set who have at least 1 PK or stool sample collected.|||Hour (h)|||Number
2544713|NCT02956122|Secondary|Apparent Volume of Distribution at Steady State (Vss) of GLASSIA|Vss of GLASSIA was reported.|Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours|PK Analysis set included all participants in the SAF set who have at least 1 PK or stool sample collected.|||Deciliter (dL)|||Number
2544714|NCT02956122|Secondary|Maximum Observed Plasma Concentration (Cmax) of GLASSIA|Cmax of GLASSIA was reported.|Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours|PK Analysis set included all participants in the SAF set who have at least 1 PK or stool sample collected.|||Milligrams per deciliter (mg/dl)|||Number
2544715|NCT02956122|Secondary|Systemic Clearance at Steady State (CLss) of GLASSIA|CLss of GLASSIA was reported.|Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours|PK Analysis set included all participants in the SAF set who have at least 1 PK or stool sample collected.|||Deciliters per hour (dL/h)|||Number
2544716|NCT02956122|Secondary|"Area Under the Plasma Concentration Curve From Time Zero to Time t AUC(0-t) of GLASSIA"|AUC(0-t) of GLASSIA was reported.|Day 1: through 48 hours, Day 13: through 48 hours, Day 22 and Day 50: through approximately 168 hours|PK Analysis set included all participants in the SAF set who have at least 1 PK or stool sample collected.|||h*mg/dL|||Number
2544717|NCT02956122|Secondary|Area Under the Plasma Concentration Curve (AUC0-inf) From Time Zero to Infinity|AUC of GLASSIA was reported.|Day 1: through 48 hours; Day 13: through 48 hours; Day 22 and Day 50: through approximately 168 hours|PK Analysis set included all participants in the SAF set who have at least 1 PK or stool sample collected.|||Hour*milligrams per deciliter (h*mg/dL)|||Number
2544718|NCT02956122|Secondary|Number of Participants With Recurrence of Primary Malignancies|Incidence of recurrence of primary malignancies was reported.|Baseline up to Day 365|SAF set consisted of all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2544719|NCT02956122|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs|Vital signs included body temperature, respiratory rate, pulse rate and systolic and diastolic blood pressure.|Baseline up to Day 56|SAF set consisted of all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2544720|NCT02956122|Secondary|Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments|Clinical laboratory assessments such as hematology, clinical chemistry, lipid and coagulation panels and urinalysis were performed.|Baseline up to Day 56|SAF set consisted of all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2544721|NCT02956122|Secondary|Number of Participants With Adverse Events (AEs), Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs and Temporally-associated AEs|An AE was defined as any untoward medical occurrence in a participant administered an investigational product (IP) that does not necessarily have a causal relationship with the treatment. An SAE was defined as an untoward medical occurrence that at any dose meets one or more of the following criteria: outcome was fatal/results in death, life-threatening, required inpatient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.|From start of study drug administration up to 371 days|SAF set consisted of all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2544722|NCT02956122|Secondary|All-cause Mortality - Percentage of Participants With an Event|All-cause mortality was defined as the time from HSCT to death due to any cause.|Days 28, 56, 100 and 180|SAF set consisted of all participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
2544723|NCT02956122|Secondary|Graft-versus-host Disease (GvHD)-Related Mortality - Percentage of Participants With an Event|Graft-versus-host disease (GvHD)-related mortality was determined by the investigator (any deaths considered related to GvHD).|Days 28, 56, 100 and 180|SAF set consisted of all participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
2544724|NCT02956122|Secondary|Infection-related Mortality - Percentage of Participants With an Event|Infection-related mortality was determined by the investigator (any deaths considered related to infection [including infections related to hematopoietic stem cell transplant {HSCT}]).|Days 28, 56, 100 and 180|SAF set consisted of all participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
2544725|NCT02956122|Secondary|Graft-versus-host Disease (GvHD)-Free Survival - Percentage of Participants With an Event|GVHD-free survival was defined as being alive without previous onset of acute GVHD or chronic GVHD requiring immunosuppressive therapy.|Days 28, 56, 100, 180 and 365|SAF set consisted of all participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
2544740|NCT02954952|Primary|Wake up Times, PSI 1.X vs. PSI 2.X|Compare the length of time from when the anesthesia has ended to the time of Return of Consciousness (ROC) between the PSI 1.X group and the PSI 2.X group.|From the end of anesthesia to the time of Return of Consciousness|Data were not collected.||||||
2544726|NCT02956122|Secondary|Failure-free Survival - Percentage of Participants With an Event|Failure-free survival was defined as the absence of all of the following criteria: Need for second-line treatment for acute GvHD, Non-relapse mortality (death during continuous complete remission) and recurrent malignancy.|Days 100 and 180|SAF set consisted of all participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
2544727|NCT02956122|Secondary|Transplant-related Mortality|Transplant-related mortality was determined by the investigator (any deaths considered related to the transplant).|Days 28, 56, 100 and 180|SAF set consisted of all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2544728|NCT02956122|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the date of randomization to the date of death due to any cause.|Days 100, 180 and 365|Safety analysis (SAF) set consisted of all participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
2544729|NCT02956122|Secondary|Duration of Gastrointestinal (GI) Response|GI response was defined as CR + PR, defined as: - GI CR was able to eat; not requiring parenteral nutrition, and passing primarily formed stools - GI PR was decrease in need for parenteral nutrition to <= 50% of required calories; and reduction of stool volume by >= 50%, without ileus. Duration of GI response was not assessed due to the termination of the study.|Baseline up to Day 365|Efficacy analysis set included all participants who were evaluated for overall response at Day 28. Participants who received at least 1 dose of study treatment and who had a lower GI biopsy that was consistent with acute GvHD were considered evaluable. Here, number of participants analyzed refer to the participants evaluable for this outcome.||||||
2544730|NCT02956122|Secondary|Duration of Overall Response (OR)|OR was defined as GvHD CR + PR, defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage - GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs. Duration of OR was not assessed due to the termination of the study.|Baseline up to Day 365|Efficacy analysis set included all participants who were evaluated for overall response at Day 28. Participants who received at least 1 dose of study treatment and who had a lower GI biopsy that was consistent with acute GvHD were considered evaluable. Here, number of participants analyzed refer to the participants evaluable for this outcome.||||||
2544731|NCT02956122|Secondary|Incidence of Chronic Graft-versus-host Disease (GvHD)|Incidence of chronic GvHD at Days 180 and 365 was reported.|Days 180 and 365|Efficacy analysis set included all participants who were evaluated for overall response at Day 28. Participants who received at least 1 dose of study treatment and who had a lower GI biopsy that was consistent with acute GvHD were considered evaluable.|||Participants|||Number
2544732|NCT02956122|Secondary|Acute Graft-versus-host Disease (GvHD) Grading at Days 28, 56 and 180|Grading of GvHD was performed by the investigator according to the modified International Bone Marrow Transplant Registry (IBMTR) grading system which classifies the degree of involvement of each organ system by stage on a scale of 0 to 4. The degree of skin involvement was staged depending upon degree and severity of the lesions: Stage 1: Maculopapular rash over less than (<) 25% of body area, Stage 2: Maculopapular rash over 25 to 50% of body area, Stage 3: Generalized erythroderma, Stage 4: Generalized erythroderma with bullous formation. Degree of GI involvement was staged based on severity of diarrhoea: Stage 1: 500 to 1000 mL/day,Stage 2: 1000 to 1500 mL/day, Stage 3: 1500 to 2000 mL/day, Stage 4: greater than (>) 2000 mL/day OR pain OR ileus. Degree of liver involvement was staged based upon serum total bilirubin level as follows: Stage 1: 2 to 3 mg/dL, Stage 2: 3 to 6 mg/dL, Stage 3: 6 to 15 mg/dL, Stage 4: >15 mg/dL.|Days 28, 56 and 180|Efficacy analysis set included all participants who were evaluated for overall response at Day 28. Participants who received at least 1 dose of study treatment and who had a lower GI biopsy that was consistent with acute GvHD were considered evaluable.|||Participants|||Count of Participants
2544733|NCT02956122|Secondary|Percentage of Participants Achieving Overall Response at Day 56|Overall response was defined as graft-versus-host disease (GvHD) complete response (CR) + partial response (PR), defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage - GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs.|Day 56|Efficacy analysis set included all participants who were evaluated for overall response at Day 28. Participants who received at least 1 dose of study treatment and who had a lower GI biopsy that was consistent with acute GvHD were considered evaluable.|||Percentage of participants|||Number
2544734|NCT02956122|Secondary|Percentage of Participants Achieving Gastrointestinal (GI) Response at Day 28|GI response was defined as complete response (CR) + partial response (PR), defined as: - GI CR was able to eat; not requiring parenteral nutrition, and passing primarily formed stools - GI PR was decrease in need for parenteral nutrition to less than or equal to (<=) 50% of required calories; and reduction of stool volume by greater than or equal to (>=) 50%, without ileus.|Day 28|Efficacy analysis set included all participants who were evaluated for overall response at Day 28. Participants who received at least 1 dose of study treatment and who had a lower GI biopsy that was consistent with acute GvHD were considered evaluable.|||Percentage of participants|||Number
2544735|NCT02956122|Primary|Percentage of Participants Achieving Overall Response (OR) At Day 28|OR was defined as graft-versus-host disease (GvHD) complete response (CR) + partial response (PR), defined as: - GvHD CR was complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage and GvHD PR was improvement of 1 stage in 1 or more organs involved in GvHD without progression in other organs.|Day 28|Efficacy analysis set included all participants who were evaluated for overall response at Day 28. Participants who received at least 1 dose of study treatment and who had a lower GI biopsy that was consistent with acute GvHD were considered evaluable.|||Percentage of participants|||Number
2544736|NCT02956005|Secondary|Renal Function After Transplantation|Data not collected - study terminated prematurely when PI left institution.|1 year|PI left institution - Analysis not completed||||||
2544737|NCT02956005|Primary|Primary Endpoint is to Determine the Rate of Calcineurin Inhibitor Toxicity as Measured by Surveillance Kidney Biopsies.|Data not collected - study terminated prematurely when PI left institution.|1 year|Analysis not completed - PI left institution||||||
2544738|NCT02954952|Other Pre-specified|Frequency of Somatic Events, PSI 1.X vs. PSI 2.X|Compare the frequency of somatic events between the PSI 1.X group and the PSI 2.X group.|Through study completion|||||||
2544741|NCT02954848|Secondary|Severity of Symptoms of Heartburn in Subgroup Stratified by Response (Improved or Not Improved) to Acid Suppressants in Participants Who Had a Medication History|Heartburn symptoms were collected by participant diaries. Participants recorded the presence and severity (Without symptom [No symptom: 0, No hindrance to daily activities: 1], With symptom [Mild: 2, Moderate: 3, Severe: 4]) of heartburn in a daily participant diary. The score range was 0-4, with the higher scores reflecting the greater severity. The mean severity of heartburn was calculated in each subgroup of the response (improved or not improved) in the participants who had a medication history of any of acid suppressants. The acid suppressants include proton pump inhibitors [PPIs], histamine H2-receptor antagonists [H2RAs], or other agents [anticholinergics or anti-gastrin drugs].|Up to Week 4|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable for this outcome measure.|||score on a scale||Full Range|Median
2544742|NCT02954848|Secondary|Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Response (Not Improved) to Acid Suppressants in Participants Who Had a Medication History|Participants recorded presence and severity (Without symptom [No symptom:0, No hindrance to daily activities:1], With symptom [Mild:2, Moderate:3, Severe:4]) of heartburn in participant diary. Score range was 0-4, higher score indicates greater severity. Cumulative rate of improvement calculated as percentage of participants who experienced symptom improvement. Cumulative improvement rate calculated in each subgroup of the response (improved or not improved) in participants who had medication history of any of acid suppressants. Acid suppressants include proton pump inhibitors [PPIs], histamine H2-receptor antagonists [H2RAs], or other agents [anticholinergics or anti-gastrin drugs]. Cumulative data was collected between Day 0 and Day 23 and is reported for following time points: Days 0, 1, 5, 9, 16, 19, and 20. Data not collected were shown as NA=Not Applicable.|Up to Week 4|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2544743|NCT02954848|Secondary|Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Response (Improved) to Acid Suppressants in Participants Who Had a Medication History|Participants recorded presence and severity (Without symptom [No symptom:0, No hindrance to daily activities:1], With symptom [Mild:2, Moderate:3, Severe:4]) of heartburn in participant diary. Score range was 0-4, higher score indicates greater severity. Cumulative rate of improvement calculated as percentage of participants who experienced symptom improvement. Cumulative improvement rate calculated in each subgroup of the response (improved or not improved) in participants who had medication history of any of acid suppressants. Acid suppressants include proton pump inhibitors [PPIs], histamine H2-receptor antagonists [H2RAs], or other agents [anticholinergics or anti-gastrin drugs]. Cumulative data collected between Day 0 and Day 23 and is reported for following time points: Days 0, 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22 and 23. Data not collected were shown as NA=Not Applicable.|Up to Week 4|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2544744|NCT02954848|Secondary|Percentage of Days Without Symptoms of Heartburn in Subgroup Stratified by Response (Improved or Not Improved) to Acid Suppressants in Participants Who Had a Medication History|Heartburn symptoms were collected by participant diaries. Participants recorded the presence and severity (Without symptom [No symptom: 0, No hindrance to daily activities: 1], With symptom [Mild: 2, Moderate: 3, Severe: 4]) of heartburn in a daily participant diary. The score range was 0-4, higher score indicates greater severity. The percentage was calculated in each subgroup of the response (improved or not improved) in the participants who had a medication history of any of acid suppressants. The acid suppressants include proton pump inhibitors [PPIs], histamine H2-receptor antagonists [H2RAs], or other agents [anticholinergics or anti-gastrin drugs].|Up to Week 4|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable for this outcome measure.|||percentage of days||Full Range|Median
2544745|NCT02954848|Secondary|Severity of Symptoms of Heartburn in Subgroup Stratified by Both the Response at Week 2 and the Endoscopic Findings (the Modified LA Classification Grade N or M)|Heartburn symptoms were collected by participant diaries. Participants recorded the presence and severity (Without symptom [No symptom: 0, No hindrance to daily activities: 1], With symptom [Mild: 2, Moderate: 3, Severe: 4]) of heartburn in a daily participant diary. The score range was 0-4, with the higher scores reflecting the greater severity. The mean severity of heartburn was calculated in each subgroup (response; Grade N and improved, response; Grade N and not improved, response; Grade M and improved, response; Grade M and not improved) according to criteria 1 and 2. The modified LA classification Grade N indicates the participants with normal mucosa and Grade M indicates the participants with minimal changes to the mucosa.|Up to Week 4|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable for this outcome measure.|||score on a scale||Full Range|Median
2544746|NCT02954848|Secondary|Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Both the Response (Not Improved Per Criteria 2) at Week 2 and the Endoscopic Findings (the Modified LA Classification Grade M)|Participants recorded presence and severity (Without symptom [No symptom:0, No hindrance to daily activities:1], With symptom [Mild:2, Moderate:3, Severe: 4]) of heartburn in participant diary. Score range was 0-4, higher score indicates greater severity. Cumulative rate of improvement calculated as percentage of participants who experienced symptom improvement. Response was evaluated per Criteria 2, i.e. Improved: participants experienced heartburn during treatment period up to Week 2 [Day 14] was lower than during run-in period; Not improved: participants experienced heartburn during treatment period up to Week 2 [Day 14] was equal to or larger than during run-in period. Modified LA classification Grade N: normal mucosa and Grade M: minimal changes to mucosa). Cumulative data was collected between Day 0 and Day 23 and is reported for following time points: Days 0, 9, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23. Data not collected shown as NA=Not Applicable.|Day 0 to Day 23|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2547192|NCT02911818|Secondary|Change in Patient Health Questionnaire (PHQ-9)|PHQ-9 is scored based on a 0-27 scale in which higher scores indicate more severe depression. Values are summed to compute the total score.|Randomization and 52 weeks||||score on a scale||Standard Error|Mean
2544747|NCT02954848|Secondary|Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Both the Response (Improved Per Criteria 2) at Week 2 and the Endoscopic Findings (the Modified LA Classification Grade M)|Participants recorded presence and severity (Without symptom [No symptom:0, No hindrance to daily activities:1], With symptom [Mild:2, Moderate:3, Severe:4]) of heartburn in participant diary. Score range was 0-4, higher score indicates greater severity. Cumulative rate of improvement calculated as percentage of participants who experienced symptom improvement. Response was evaluated per Criteria 2, i.e. Improved: participants experienced heartburn during treatment period up to Week 2 [Day 14] was lower than during run-in period; Not improved: participants experienced heartburn during treatment period up to Week 2 [Day 14] was equal or larger than during run-in period. Modified LA classification Grade N: normal mucosa and Grade M: minimal changes to mucosa. Cumulative data collected between Day 0 and 24 and reported for following time points: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24. Data not collected shown as NA=Not Applicable.|Day 0 to Day 24|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2544748|NCT02954848|Secondary|Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Both the Response (Not Improved Per Criteria 2) at Week 2 and the Endoscopic Findings (the Modified LA Classification Grade N)|Participants recorded presence and severity (Without symptom [No symptom:0, No hindrance to daily activities:1], With symptom [Mild:2, Moderate:3, Severe:4]) of heartburn in participant diary. Score range was 0-4, higher score indicates greater severity. Cumulative rate of improvement was calculated as percentage of participants who experienced symptom improvement. Response was evaluated per Criteria 2, i.e. Improved: participants experienced heartburn during treatment period up to Week 2 [Day 14] was lower than during run-in period; Not improved: participants experienced heartburn during treatment period up to Week 2 [Day 14] was equal to or larger than during run-in period. Modified LA classification Grade N: normal mucosa and Grade M: minimal changes to mucosa. Cumulative data was collected between Day 0 and Day 24 and is reported for following time points: Days 0, 5, 9, 11, 12, 13, 14, 19, 20, 21, 22, 23, and 24. Data not collected were shown as NA=Not Applicable.|Day 0 to Day 24|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2544749|NCT02954848|Secondary|Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Both the Response (Improved Per Criteria 2) at Week 2 and the Endoscopic Findings (the Modified LA Classification Grade N)|Participants recorded presence and severity (Without symptom [No symptom:0, No hindrance to daily activities:1], With symptom [Mild:2, Moderate:3, Severe:4]) of heartburn in participant diary. Score range was 0-4, higher score indicates greater severity. Cumulative rate of improvement calculated as percentage of participants who experienced symptom improvement. Response was evaluated per Criteria 2, i.e. Improved: participants experienced heartburn during treatment period up to Week 2 [Day 14] was lower than during run-in period; Not improved: participants experienced heartburn during treatment period up to Week 2 [Day 14] was equal to or larger than during run-in period. Modified LA classification Grade N: normal mucosa and Grade M: minimal changes to mucosa). Cumulative data collected between Day 0 and 22 and reported for following time points: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, and 22. Data not collected shown as NA=Not Applicable.|Day 0 to Day 22|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2544750|NCT02954848|Secondary|Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Both the Response (Not Improved Per Criteria 1) at Week 2 and the Endoscopic Findings (the Modified LA Classification Grade M)|Participants recorded presence and severity (Without symptom [No symptom:0, No hindrance to daily activities:1], With symptom [Mild:2, Moderate:3, Severe:4]) of heartburn in a daily participant diary. Score range was 0-4, higher score indicates greater severity. Cumulative rate of improvement calculated as percentage of participants who experienced symptom improvement. Response evaluated per Criteria 1, i.e. Improved: participants experienced heartburn on < 2 days of the 7 days prior to Week 2 [Day 8 to 14]; Not improved: participants experienced heartburn on >= 2 days of 7 days prior to Week 2 [Day 8 to 14]. Modified LA classification Grade N indicates participants with normal mucosa and Grade M indicates participants with minimal changes to mucosa). Cumulative data collected between Day 0 and 24 and reported for following time points: Days 0, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24. Data not collected were shown as NA=Not Applicable.|Day 0 to Day 24|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2544751|NCT02954848|Secondary|Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Both the Response (Improved Per Criteria 1) at Week 2 and the Endoscopic Findings (the Modified LA Classification Grade M)|Participants recorded presence and severity (Without symptom [No symptom:0, No hindrance to daily activities:1], With symptom [Mild:2, Moderate:3, Severe:4]) of heartburn in participant diary. Score range was 0-4, higher score indicates greater severity. Cumulative rate of improvement calculated as percentage of participants who experienced symptom improvement. Response was evaluated per Criteria 1, i.e. Improved: participants experienced heartburn on less than 2 days of 7 days prior to Week 2 [Day 8 through Day 14]; Not improved: participants experienced heartburn on 2 days or more of 7 days prior to Week 2 [Day 8 through Day 14]. Modified LA classification Grade N indicates participants with normal mucosa and Grade M indicates participants with minimal changes to mucosa). Cumulative data collected between Day 0 and Day 22 and is reported for following time points: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 11, 15, 16, 17, 18, 20, 21 and 22. Data not collected were shown as NA=Not Applicable.|Day 0 to Day 22|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2544770|NCT02954653|Secondary|Peak and Trough PF-06747143 Concentrations for Selected Doses [Part 2]|Peak and trough PF-06747143 concentrations were to be observed directly from data.|Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment|Part 2 was not conducted.||||||
2544752|NCT02954848|Secondary|Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Both the Response (Not Improved Per Criteria 1) at Week 2 and the Endoscopic Findings (the Modified LA Classification Grade N)|Participants recorded presence and severity (Without symptom [No symptom:0, No hindrance to daily activities:1], With symptom [Mild:2, Moderate:3, Severe:4]) of heartburn in participant diary. Score range was 0-4, higher scores indicates greater severity. Cumulative rate of improvement calculated as percentage of participants who experienced symptom improvement. Response was evaluated per Criteria 1, i.e. Improved: participants experienced heartburn on less than 2 days of 7 days prior to Week 2 [Day 8 through Day 14]; Not improved: participants experienced heartburn on 2 days or more of 7 days prior to Week 2 [Day 8 through Day 14]. Modified LA classification Grade N indicates participants with normal mucosa and Grade M indicates participants with minimal changes to mucosa). Cumulative data was collected between Day 0 and Day 22 and is reported for following time points: Days 0, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21 and 22. Data not collected were shown as NA=Not Applicable.|Day 0 to Day 24|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2544753|NCT02954848|Secondary|Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Both the Response (Improved Per Criteria 1) at Week 2 and the Endoscopic Findings (the Modified LA Classification Grade N)|Participants recorded the presence and severity (Without symptom [No symptom:0, No hindrance to daily activities:1], With symptom [Mild:2, Moderate:3, Severe:4]) of heartburn in participant diary. Score range was 0-4, higher scores indicates greater severity. Cumulative rate of improvement calculated as percentage of participants who experienced symptom improvement. Response was evaluated per Criteria 1, i.e. Improved: participants experienced heartburn on less than 2 days of 7 days prior to Week 2 [Day 8 through Day 14]; Not improved: participants experienced heartburn on 2 days or more of the 7 days prior to Week 2 [Day 8 through Day 14]. Modified LA classification Grade N: normal mucosa and Grade M: minimal changes to the mucosa. Cumulative data was collected between Day 0 and Day 22 and is reported for following time points: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 11, 19, 20, and 22. Data not collected were shown as NA=Not Applicable.|Day 0 to Day 22|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2544754|NCT02954848|Secondary|Percentage of Days Without Symptoms of Heartburn Stratified by Subgroup of Both the Response at Week 2 and the Endoscopic Findings (the Modified LA Classification Grade N or M)|Heartburn symptoms were collected by participant diaries. Participants recorded the presence and severity (Without symptom [No symptom: 0, No hindrance to daily activities: 1], With symptom [Mild: 2, Moderate: 3, Severe: 4]) of heartburn in a daily participant diary. The score range was 0-4, higher scores indicates greater severity. The percentage was calculated in each subgroup (response; Grade N and improved, response; Grade N and not improved, response; Grade M and improved, response; Grade M and not improved) according to Criteria 1 and 2. The modified LA classification Grade N indicates the participants with normal mucosa and Grade M indicates the participants with minimal changes to the mucosa.|Up to Week 4|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable for this outcome measure.|||percentage of days||Full Range|Median
2544755|NCT02954848|Secondary|Severity of Symptoms of Heartburn in Subgroup Stratified by Endoscopic Findings (the Modified LA Classification Grade N or M) at Baseline|Heartburn symptoms were collected by participant diaries. Participants recorded the presence and severity (Without symptom [No symptom:0, No hindrance to daily activities:1], With symptom [Mild:2, Moderate:3, Severe:4]) of heartburn in a daily participant diary. The score range was 0-4, with the higher scores reflecting the greater severity. The severity of heartburn was calculated in each subgroup of the endoscopic findings where Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity; Grade A: non-confluent mucosal breaks <5mm in length; Grade B: non-confluent mucosal breaks ≥5mm in length; Grade C: confluent mucosal breaks <75% circumferential; Grade D: confluent mucosal breaks >75% circumferential.|Up to Week 4|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who had endoscopic findings.|||score on a scale||Full Range|Median
2544756|NCT02954848|Secondary|Cumulative Rate of Improvement in Heartburn in Subgroup Stratified by Endoscopic Findings (the Modified LA Classification Grade M) at Baseline|Participants recorded presence and severity (Without symptom [No symptom:0, No hindrance to daily activities:1], With symptom [Mild:2, Moderate:3, Severe:4]) of heartburn in participant diary. Score range was 0-4, higher scores indicates greater severity. Cumulative rate of improvement calculated as percentage of participants who experienced symptom improvement. Cumulative rate calculated in subgroup of Grade M per modified LA classification. Modified LA classification Grade N: normal mucosa; Grade M: minimal changes to mucosa; Grade A: nonconfluent mucosal breaks <5mm in length; Grade B: non-confluent mucosal breaks ≥5mm in length; Grade C: confluent mucosal breaks <75% circumferential; Grade D: confluent mucosal breaks >75% circumferential. Cumulative data collected between Day 0 and 24 and reported for time points: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24. Data not collected shown as NA=Not Applicable.|Day 0 to Day 24|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable at each category.|||percentage of participants|||Number
2544771|NCT02954653|Secondary|Terminal Elimination Half-Life (t1/2) at Steady State of PF-06747143 [Parts 1 and 2]|t1/2 is the time measured for the serum concentration to decrease by one half.|Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment|Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.||||||
2544772|NCT02954653|Secondary|Volume of Distribution at Steady State (Vss) at of PF-06747143 [Parts 1 and 2]|Vss is the apparent volume of distribution at steady-state. If data permitted, Vss was to be determined following multiple dosing to characterize the PK.|Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment|Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.||||||
2544757|NCT02954848|Secondary|Cumulative Rate of Improvement in Heartburn in Subgroup Stratified by Endoscopic Findings (the Modified LA Classification Grade N) at Baseline|Participants recorded presence and severity (Without symptom [No symptom:0, No hindrance to daily activities:1], With symptom [Mild:2, Moderate:3, Severe:4]) of heartburn in participant diary. The score range was 0-4, higher scores indicates greater severity. Cumulative rate of improvement calculated as percentage of participants who experienced symptom improvement. Cumulative rate calculated in subgroup of Grade N per modified LA classification. Modified LA classification Grade N: normal mucosa; Grade M: minimal changes to mucosa; Grade A: nonconfluent mucosal breaks <5mm in length; Grade B: non-confluent mucosal breaks ≥5mm in length; Grade C: confluent mucosal breaks <75% circumferential; Grade D: confluent mucosal breaks >75% circumferential. Cumulative data collected between Day 0 and 24 and reported for time points: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24. Data not collected shown as NA=Not Applicable.|Day 0 to Day 24|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable at each category.|||percentage of participants|||Number
2544758|NCT02954848|Secondary|Percentage of Days Without Symptoms of Heartburn in Subgroup Stratified by Endoscopic Findings (the Modified LA Classification Grade N or M) at Baseline|Heartburn symptoms were collected by participant diaries. Participants recorded the presence and severity (Without symptom [No symptom: 0, No hindrance to daily activities: 1], With symptom [Mild: 2, Moderate: 3, Severe: 4]) of heartburn in a daily participant diary. The score range was 0-4, higher scores indicates greater severity. The percentage was calculated in each subgroup of the endoscopic findings where Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity; Grade A: non-confluent mucosal breaks <5mm in length; Grade B: non-confluent mucosal breaks ≥5mm in length; Grade C: confluent mucosal breaks <75% circumferential; Grade D: confluent mucosal breaks >75% circumferential.|Up to Week 4|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who had endoscopic findings.|||percentage of days||Full Range|Median
2544759|NCT02954848|Secondary|Severity of Symptoms of Heartburn in Subgroup Stratified by Response (Improved or Not Improved) at Week 2|Participants recorded the presence and severity (Without symptom [No symptom: 0, No hindrance to daily activities: 1], With symptom [Mild: 2, Moderate: 3, Severe: 4]) of heartburn in a daily participant diary. The score range was 0-4, the higher scores indicates greater severity. The severity was calculated in each subgroup of response (improved or not improved) according to Criteria 1, i.e. Improved: participants experienced heartburn on less than 2 days of the 7 days prior to Week 2 [Day 8 through Day 14]; Not improved: participants experienced heartburn on 2 days or more of the 7 days prior to Week 2 [Day 8 through Day 14] and Criteria 2, i.e. Improved: proportion of days the participants experienced heartburn during the treatment period up to Week 2 [Day 14] was lower than that during the run-in period; Not improved: proportion of days the participants experienced heartburn during the treatment period up to Week 2 [Day 14] was equal to or larger than that during the run-in period.|Up to Week 4|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable at each category.|||score on a scale||Full Range|Median
2544760|NCT02954848|Secondary|Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Response (Not Improved Per Criteria 2) at Week 2|Participants recorded presence and severity (Without symptom [No symptom:0, No hindrance to daily activities:1], With symptom [Mild:2, Moderate:3, Severe:4]) of heartburn in daily participant diary. The score range was 0-4, with higher scores reflecting the greater severity. Cumulative rate of improvement calculated as percentage of participants who experienced symptom improvement. The response evaluated per Criteria 2, i.e. Improved: proportion of days participant experienced heartburn during treatment period up to Week 2 [Day 14] was lower than that during run-in period; Not improved: proportion of days participants experienced heartburn during treatment period up to Week 2 [Day 14] was equal to or larger than that during run-in period. Cumulative data was collected between Day 0 and Day 24 and is reported for following time points: Days 0, 5, 9, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24. Data not collected shown as NA=Not Applicable.|Day 0 to Day 24|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable at each category.|||percentage of participants|||Number
2544761|NCT02954848|Secondary|Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Response (Improved Per Criteria 2) at Week 2|Participants recorded presence and severity (Without symptom [No symptom:0, No hindrance to daily activities:1], With symptom [Mild:2, Moderate:3, Severe:4]) of heartburn in daily participant diary. The score range was 0-4, with higher scores reflecting the greater severity. Cumulative rate of improvement calculated as percentage of participants who experienced symptom improvement. Response evaluated per Criteria 2, i.e. Improved: proportion of days participant experienced heartburn during treatment period up to Week 2 [Day 14] was lower than that during run-in period; Not improved: proportion of days participants experienced heartburn during treatment period up to Week 2 [Day 14] was equal to or larger than that during the run-in period. Cumulative data was collected between Day 0 and Day 24 and is reported for following time points: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24. Data not collected were shown as NA=Not Applicable.|Day 0 to Day 24|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable at each category.|||percentage of participants|||Number
2544773|NCT02954653|Secondary|Clearance (CL) at Steady State of PF-06747143 [Parts 1 and 2]|If data permitted, CL was to be determined following multiple dosing to characterize the PK.|Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment|Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.||||||
2544774|NCT02954653|Secondary|Accumulation Ratio (Rac) of PF-06747143 [Parts 1 and 2]|Accumulation ratio (Rac) was to be obtained from AUCtau at steady state (AUCtau,ss) divided by AUCtau after single dose.|Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment|Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.||||||
2544762|NCT02954848|Secondary|Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Response (Not Improved Per Criteria 1) at Week 2|Participants recorded presence and severity (Without symptom [No symptom:0, No hindrance to daily activities:1], With symptom [Mild:2, Moderate:3, Severe:4]) of heartburn in daily participant diary. The score range was 0-4, with the higher scores reflecting the greater severity. Cumulative rate of improvement is calculated as percentage of participants who experienced symptom improvement. The response was evaluated per Criteria 1, i.e. Improved: the participants experienced heartburn on less than 2 days of the 7 days prior to Week 2 [Day 8 through Day 14]; Not improved: the participants experienced heartburn on 2 days or more of the 7 days prior to Week 2 [Day 8 through Day 14]. Cumulative data was collected between Day 0 and Day 24 and is reported for following time points: Days 0, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24. Data not collected were shown as NA = Not Applicable.|Day 0 to Day 24|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable at each category.|||percentage of participants|||Number
2544763|NCT02954848|Secondary|Cumulative Rate of Improvement in Symptoms of Heartburn in Subgroup Stratified by Response (Improved Per Criteria 1) at Week 2|Participants recorded presence and severity (Without symptom [No symptom:0, No hindrance to daily activities:1], With symptom [Mild:2, Moderate:3, Severe:4]) of heartburn in daily participant diary. The score range was 0-4, with the higher scores reflecting the greater severity. Cumulative rate of improvement was calculated as percentage of participants who experienced symptom improvement. The response was evaluated per Criteria 1, i.e. Improved: the participants experienced heartburn on less than 2 days of the 7 days prior to Week 2 [Day 8 through Day 14]; Not improved: the participants experienced heartburn on 2 days or more of the 7 days prior to Week 2 [Day 8 through Day 14]. Cumulative data was collected between Day 0 and Day 22 and is reported for following time points: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 11, 15, 16, 17, 18, 19, 20, 21, and 22. Data not collected were shown as NA = Not Applicable.|Day 0 to Day 22|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable at each category.|||percentage of participants|||Number
2544764|NCT02954848|Secondary|Percentage of Days Without Symptoms of Heartburn in Subgroup Stratified by Response (Improved or Not Improved) at Week 2|Participants recorded the presence and severity of heartburn in a daily participant diary. Percentage of days without heartburn was calculated in each subgroup of the response (improved or not improved) according to Criteria 1, i.e. Improved: the participants experienced heartburn on less than 2 days of the 7 days prior to Week 2 [Day 8 through Day 14]; Not improved: the participants experienced heartburn on 2 days or more of the 7 days prior to Week 2 [Day 8 through Day 14] and Criteria 2, i.e. Improved: the proportion of days the participants experienced heartburn during the treatment period up to Week 2 [Day 14] was lower than that during the run-in period; Not improved: the proportion of days the participants experienced heartburn during the treatment period up to Week 2 [Day 14] was equal to or larger than that during the run-in period.|Up to Week 4|FAS included participants who were randomized and received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable at each category.|||percentage of days||Full Range|Median
2544765|NCT02954848|Primary|Severity of Symptoms of Heartburn|Participants recorded the presence and severity (Without symptom [No symptom: 0, No hindrance to daily activities: 1], With symptom [Mild: 2, Moderate: 3, Severe: 4]) of heartburn in a daily participant diary. The score range was 0-4, with the higher scores reflecting the greater severity. The severity of heartburn was calculated by the number of severity score in daily diaries.|Up to Week 4|FAS included participants who were randomized and received at least one dose of the study drug.|||score on a scale||Full Range|Median
2544766|NCT02954848|Primary|Cumulative Rate of Improvement in Symptoms of Heartburn|Heartburn symptoms were collected by participant diaries. Participants recorded the presence and severity (Without symptom [No symptom: 0, No hindrance to daily activities: 1], With symptom [Mild: 2, Moderate: 3, Severe: 4]) of heartburn in a daily participant diary. The score range was 0-4, with the higher scores reflecting the greater severity. Cumulative rate of improvement was calculated as percentage of participants who experienced symptom improvement. Symptom improvement was defined as symptoms experienced on less than 2 days of the last 7 days. The cumulative data was collected between Day 0 and Day 24 and is reported for the following time points: Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24. Data not collected were shown as NA = Not Applicable.|Day 0 to Day 24|FAS included participants who were randomized and received at least one dose of the study drug.|||percentage of participants|||Number
2544767|NCT02954848|Primary|Percentage of Days Without Symptoms of Heartburn|Heartburn symptoms were collected by participant diaries. Participants recorded the presence and severity (Without symptom [No symptom: 0, No hindrance to daily activities: 1], With symptom [Mild: 2, Moderate: 3, Severe: 4]) of heartburn in a daily participant diary. The score range was 0-4, with the higher scores reflecting the greater severity. Reported data was the percentage of days for each group, calculated by the number of days without heartburn divided by the number of days of treatment period.|Up to Week 4|Full analysis set (FAS) included participants who were randomized and received at least one dose of the study drug.|||percentage of days||Full Range|Median
2544768|NCT02954653|Primary|Progression Free Survival [Part 2]|Progression/relapse free survival is the time from the start of study treatment to first documentation of disease progression or to death due to any cause, whichever occurrs first. Disease progression/relapse: Bone marrow blast ≥ 5%; or reappearance of blast in the blood; or development of extramedullary disease (EMD).|16 weeks|Part 2 was not conducted.||||||
2544769|NCT02954653|Primary|Duration of Objective Response Rate (ORR) [Part 2]|"Duration of ORR is the time from first documentation of MLFS, CR, CRc, CRm, PR, CRi or PRi to date of first documentation of disease progression or death due to any cause.~MLFS: BM blasts <5%; absence of blasts with Auer rods and EMD. CR: MLFS criteria; ANC>1000/ul and platelet >100,000/ul; independence from red cell transfusions.~CRc: Reversion to a normal karyotype at the time of CR in cases with an abnormal karyotype at the time of diagnosis; based on the evaluation of 20 metaphase cells from BM.~CRm: Reversion to a molecular-negative phenotype at the time of CR. CRi: All CR criteria except for ANC <1000/ul or platelet <100,000/ul. PR: ANC >1000/ul and platelet >100,000/ul; BM blasts decreased to 5-25% and ≥50% decrease from pre-treatment levels.~PRi: ANC <1000/ul or platelet <100,000/ul; BM blasts decreased to 5-25% and ≥50% decrease from pre-treatment levels.~Disease progression/relapse: BM blast ≥5%; or reappearance of blast in the blood; or development of EMD."|16 weeks|Part 2 was not conducted.||||||
2544775|NCT02954653|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau,ss) of PF-06747143 [Parts 1 and 2]|AUCtau is area under the serum concentration versus time profile from time zero to the time tau (ie, dosing interval). Assuming steady state was achieved, AUCtau,ss was to be determined following multiple dosing to characterize the PK.|Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment|Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.||||||
2544776|NCT02954653|Secondary|Minimum Observed Serum Trough Concentration at Steady State (Cmin,ss) of PF-06747143 [Parts 1 and 2]|Cmin is the minimum observed serum concentration. Assuming steady state was achieved, Cmin,ss was to be determined following multiple dosing to characterize the PK.|Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment|Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.||||||
2544777|NCT02954653|Secondary|Maximum Serum Concentration at Steady State (Cmax,ss) of PF-06747143 [Parts 1 and 2]|Assuming steady state was achieved, Cmax,ss was to be determined following multiple dosing to characterize the PK.|Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment|Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.||||||
2544778|NCT02954653|Secondary|Clearance (CL) of PF-06747143 [Parts 1 and 2]|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment|Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.||||||
2544779|NCT02954653|Secondary|Terminal Elimination Half-Life (t1/2) of PF-06747143 [Parts 1 and 2]|t1/2 is the time measured for the serum concentration to decrease by one half. If data permitted, t1/2 was to be estimated.|Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment|Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.||||||
2544780|NCT02954653|Secondary|Apparent Volume of Distribution (Vd) of PF-06747143 [Parts 1 and 2]|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment|Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.||||||
2544781|NCT02954653|Secondary|Area Under the Curve From Time Zero to Infinity (AUCinf) of PF-06747143 [Parts 1 and 2]|AUCinf is area under the serum concentration versus time profile from time zero extrapolated to infinite time. If data permitted, AUCinf was to be estimated.|Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment|Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.||||||
2544782|NCT02954653|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06747143 [Parts 1 and 2]|AUClast is area under the serum concentration versus time profile from time zero to the time of the last quantifiable concentration.|Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment|Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.||||||
2544783|NCT02954653|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-06747143 [Parts 1 and 2]|Tmax of PF-06747143 was to be observed directly from data as time of first occurrence of peak serum concentration.|Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment|Due to the early termination of the study, Part 1 PK assessments were not completed and Part 2 was not conducted.||||||
2544784|NCT02954653|Secondary|Maximum Observed Serum Concentration (Cmax) of PF-06747143 [Parts 1 and 2]|Cmax of PF-06747143 was the peak serum concentration to be observed directly from data.|Cycle 1 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 1 Day 8 at 0 hour; Cycle 1 Day 15 at 0 and 1 hour; Cycle 1 Day 22 at 0 hour; Cycle 2 Day 1 at 0, 1, 24, 48, 96 hours; Cycle 2 Days 8, 15 and 22 at 0 hour; Subsequent cycles: Day 1 at 0 hour; End of treatment|Due to the early termination of the study, Part 1 pharmacokinetics (PK) assessments were not completed and Part 2 was not conducted.||||||
2544785|NCT02954653|Secondary|Incidence of Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Against PF-06747143 [Part 2]|Samples were to be analyzed for ADA using a validated assay. ADA positive samples were to be further analyzed for Nab using a validated assay.|Days 1 and 15 pre-dose of Cycle 1, Day 1 pre-dose of Cycles 2-6, Day 1 pre-dose of every 3 cycles thereafter, and at end of treatment|Part 2 was not conducted.||||||
2544786|NCT02954653|Secondary|Incidence of Neutralizing Antibodies (Nab) Against PF-06747143 [Part 1]|Samples tested positive for ADA were to be further analyzed for Nab using a validated assay.|Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, end of treatment|No data was collected as Nab analysis was not performed.||||||
2544787|NCT02954653|Secondary|Incidence of Anti-Drug Antibodies (ADA) Against PF-06747143 [Part 1]|Samples were tested for ADA using a validated assay. Number of participants with positive ADA samples was determined.|Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, end of treatment|All enrolled patients who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2544788|NCT02954653|Secondary|Progression Free Survival [Part 1]|Progression/relapse free survival is the time from the start of study treatment to first documentation of disease progression or to death due to any cause, whichever occurrs first. Disease progression/relapse: Bone marrow blast ≥ 5%; or reappearance of blast in the blood; or development of extramedullary disease (EMD).|16 weeks|All enrolled participants who received at least 1 dose of study treatment and had a baseline disease assessment.|||months||Full Range|Median
2544789|NCT02954653|Secondary|Duration of Objective Response Rate (ORR) [Part 1]|"Duration of ORR is the time from first documentation of MLFS, CR, CRc, CRm, PR, CRi or PRi to date of first documentation of disease progression or death due to any cause.~MLFS: BM blasts <5%; absence of blasts with Auer rods and EMD. CR: MLFS criteria; ANC>1000/ul and platelet >100,000/ul; independence from red cell transfusions.~CRc: Reversion to a normal karyotype at the time of CR in cases with an abnormal karyotype at the time of diagnosis; based on the evaluation of 20 metaphase cells from BM.~CRm: Reversion to a molecular-negative phenotype at the time of CR. CRi: All CR criteria except for ANC <1000/ul or platelet <100,000/ul. PR: ANC >1000/ul and platelet >100,000/ul; BM blasts decreased to 5-25% and ≥50% decrease from pre-treatment levels.~PRi: ANC <1000/ul or platelet <100,000/ul; BM blasts decreased to 5-25% and ≥50% decrease from pre-treatment levels.~Disease progression/relapse: BM blast ≥5%; or reappearance of blast in the blood; or development of EMD."|16 weeks|All enrolled participants who received at least 1 dose of study treatment and had a baseline disease assessment.|||months||Full Range|Median
2544790|NCT02954653|Secondary|Objective Response Rate (ORR) - Percentage of Participants With Objective Response [Part 1]|"Objective Response was defined as morphologic leukemia-free state (MLFS), complete remission (CR), cytogenetic CR (CRc), molecular CR (CRm), partial remission (PR), or CR or PR with incomplete blood count recovery (CRi or PRi).~MLFS: Bone marrow (BM) blasts <5%; absence of blasts with Auer rods and extramedullary disease (EMD).~CR: MLFS criteria; absolute neutrophil count (ANC)>1000/ul and platelet >100,000/ul; independence from red cell transfusions.~CRc: Reversion to a normal karyotype at the time of CR in cases with an abnormal karyotype at the time of diagnosis; based on the evaluation of 20 metaphase cells from BM.~CRm: Reversion to a molecular-negative phenotype at the time of CR. CRi: All CR criteria except for ANC <1000/ul or platelet <100,000/ul. PR: ANC >1000/ul and platelet >100,000/ul; BM blasts decreased to 5-25% and ≥50% decrease from pre-treatment levels.~PRi: ANC <1000/ul or platelet <100,000/ul; BM blasts decreased to 5-25% and ≥50% decrease from pre-treatment levels."|16 weeks|All enrolled participants who received at least 1 dose of study treatment and had a baseline disease assessment.|||percentage of participants|||Number
2544791|NCT02954653|Secondary|Number of Participants With Chemistry Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1]|Chemistry laboratory abnormalities included alanine aminotransferase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), bilirubin (total), creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, and hypophosphatemia. Each laboratory parameter was graded per NCI CTCAE version 4.03.|1 year|All enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2544792|NCT02954653|Secondary|Number of Participants With Hematology Laboratory Abnormalities by Type and Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1]|Hematology laboratory abnormalities included anemia, hemoglobin increased, lymphocyte count increased, lymphopenia, neutrophil count decreased, platelet count decreased, and white blood cell (WBC) decreased. Each laboratory parameter was graded per NCI CTCAE version 4.03.|1 year|All enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2544793|NCT02954653|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Part 1]|An AE was any untoward medical occurrence in a participant administered a product or medical device without regard to possibility of causal relationship. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs.|1 year|All enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2544794|NCT02954653|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Part 1]|An AE was any untoward medical occurrence in a participant administered a product or medical device without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs included non-serious AEs and SAEs. Causality to study treatment was determined by the investigator.|1 year|All enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2544795|NCT02954653|Primary|Objective Response Rate (ORR) - Percentage of Participants With Objective Response [Part 2]|"Objective Response was defined as morphologic leukemia-free state (MLFS), complete remission (CR), cytogenetic CR (CRc), molecular CR (CRm), partial remission (PR), or CR or PR with incomplete blood count recovery (CRi or PRi).~MLFS: Bone marrow (BM) blasts <5%; absence of blasts with Auer rods and extramedullary disease (EMD).~CR: MLFS criteria; absolute neutrophil count (ANC)>1000/ul and platelet >100,000/ul; independence from red cell transfusions.~CRc: Reversion to a normal karyotype at the time of CR in cases with an abnormal karyotype at the time of diagnosis; based on the evaluation of 20 metaphase cells from BM.~CRm: Reversion to a molecular-negative phenotype at the time of CR. CRi: All CR criteria except for ANC <1000/ul or platelet <100,000/ul. PR: ANC >1000/ul and platelet >100,000/ul; BM blasts decreased to 5-25% and ≥50% decrease from pre-treatment levels.~PRi: ANC <1000/ul or platelet <100,000/ul; BM blasts decreased to 5-25% and ≥50% decrease from pre-treatment levels."|16 weeks|Part 2 was not conducted.||||||
2544878|NCT02953678|Secondary|Nonrelapse Mortality (NRM)|Defined as the proportion of subjects who died due to causes other than malignancy relapse.|From baseline to Months 6, 9, 12, and 24|Efficacy Evaluable Participants including all responders as of the data cutoff (02 JUL 2018).|||percentage of participants||95% Confidence Interval|Number
2544796|NCT02954653|Primary|Number of Participants With Laboratory Abnormalities [Part 2]|Following parameters were to be analyzed for laboratory examination: hematology (hemoglobin, platelets, white blood cell [WBC], absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils, percent blast cells); chemistry (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose [non-fasted], albumin, phosphorous or phosphate); coagulation (prothrombin time [PT] or international normalized ratio [INR], partial thromboplastin time [PTT] or activated PTT [aPTT]); urinalysis (urine dipstick for urine protein: if positive collect 24 hours and microscopic [reflex testing]; urine dipstick for urine blood: if positive collect a microscopic [reflex testing]); pregnancy test (for female participants of childbearing potential, serum or urine).|1 year|No data to report as Part 2 was not conducted.||||||
2544797|NCT02954653|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) [Part 2]|An AE was any untoward medical occurrence in a participant administered a product or medical device without regard to possibility of causal relationship. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment.|1 year|No data to report as Part 2 was not conducted.||||||
2544798|NCT02954653|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs) [Part 1]|DLTs were classified according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and were defined as any of a predefined set of unacceptable hematologic and non-hematologic adverse events (AEs) occurring in the first treatment cycle unless clearly determined unrelated to PF-06747143. In addition, clinically important or persistent toxicities that were not included in the pre-specified criteria could be considered a DLT following review by the investigators and sponsor.|Day 1 to Day 28 of Cycle 1|All enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2544799|NCT02954601|Secondary|Calculate the Difference Between Values of Pre-treatment and End-of-treatment Mean Daytime CGM Glucose|Calculate the difference between pre-treatment (Day 3) and end of treatment (Day 8) mean daytime CGM glucose for single and multiple doses of ORMD-0801 vs placebo.|Day 3 and Day 8 (two timepoints)|Intend to Treat mean values reported for Doses 1, 2, and 3 are placebo-adjusted doses (Active dose mean minus placebo dose mean)|||mg/dL||Standard Error|Mean
2544800|NCT02954601|Secondary|The Number Hypoglycemic Events for Single and Multiple Doses of ORMD-0801 vs Placebo|The number of safety parameter hypoglycemic events for single and multiple doses of ORMD-0801 vs placebo.|Day 3 through Day 8 of treatment|Safety population|||number of hypoglycemic events|||Number
2544801|NCT02954601|Secondary|Calculate the C-peptide Ratio for Single and Multiple Doses of ORMD-0801 vs Placebo.|For each dose, calculate the ratio of the C-Peptide measurement area-under-the-curve (ng-hr/mL) Day 8 to the C-peptide measurement area-under-the-curve (ng-hr/mL) Day 3. This ratio is called the C-peptide Ratio.|Day 3 and Day 8|Intend to Treat (ITT)|||ratio||Standard Error|Mean
2544802|NCT02954601|Primary|Change in Glucose Levels Between Pre-treatment and End of Treatment as Measured by 24-hour Continuous Glucose Monitoring (CGM)|Measure the change in Glucose (mg/dL) by 24 hour CGM between Day3 and Day8 (Change in mg/dL between run-in and Day 5 of Active treatment)|Day 3 (run-in) and Day 8 (Day 5 of Active treatment)|Intend to Treat Population|||mg/dL||Standard Deviation|Mean
2544803|NCT02954575|Other Pre-specified|Efficacy of Wilate in Surgical Prophylaxis|Hemostatic efficacy was assessed at the end of surgery by the surgeon and at end of the postoperative period by the hematologist, using a 4-point hemostatic efficacy scale including the four items: 'excellent' (best possible outcome), 'good', 'moderate' and 'none' (worst outcome). Overall efficacy was assessed by the investigator, taking both the intra and postoperative assessments into account, and using the 'excellent,' 'good,' moderate,' and 'none' scale.|6 months||||Participants|||Count of Participants
2544804|NCT02954575|Secondary|Virus Safety Measured by the Number of Parvovirus B19 Seroconversions Between Baseline (BL) and End of Study|Virus safety was evaluated by taking a plasma sample for parvovirus B19 antibody testing before the first injection of Wilate. All patients negative at screening were tested again at the study completion visit. The number with Parvovirus B19 seroconversions between BL and end of study was recorded.|6 months|In the FAS population (N=55), the viral safety of Wilate was analyzed for all patients at baseline.|||Participants|||Number
2544805|NCT02954575|Secondary|Immunogenicity of Wilate by Testing for FVIII Inhibitors|FVIII inhibitor activity was determined at each study visit before the injection of Wilate using the modified Bethesda assay (Nijmegen modification).|6 months||||Participants|||Count of Participants
2544806|NCT02954575|Secondary|Safety and Tolerability of Wilate by Monitoring Adverse Events (AEs) Throughout the Study|At each (scheduled or unscheduled) study visit, AEs were documented by the investigator throughout the study.|6 months|In the FAS population (N=55), the safety and tolerability of Wilate was analysed for all patients experiencing adverse events (AEs) throughout the study.|||Number of adverse events|||Number
2544807|NCT02954575|Secondary|Association Between VWF:Ag Concentration and the FVIII:C Half-life of Wilate|ANOVA was used in an exploratory sense to assess an association between VWF:Ag with the FVIII:C half-life of Wilate. This was analyzed by calculating the mean square in a one-stage assay.|6 months||||Beta coefficient|||Number
2544808|NCT02954575|Secondary|Association Between ABO Blood Type and the FVIII:C Half-life of Wilate (OS Assay)|Analysis of variance (ANOVA) was used in an exploratory sense to assess an association between ABO blood type and the FVIII:C half-life of Wilate. This was analyzed by calculating the mean square in a one-stage assay.|6 months||||Beta coefficient|||Number
2544809|NCT02954575|Secondary|Incremental in Vivo Recovery (IVR) of Wilate Over Time|The rise in FVIII activity in IU/dl per unit dose administered in IU/kg was determined from all patients at baseline, 3 and 6 months, using the OS assay.|Baseline, 3 and 6 months||||kg/dL||Standard Deviation|Mean
2544810|NCT02954575|Secondary|Pharmacokinetic (PK) Assessment (Maximum Plasma Concentration [Cmax]) of FVIII:C|PK assessments of FVIII:C were conducted using the one-stage (OS) assay. The maximum plasma concentration of FVIII:C was calculated based on the FVIII:C values measured in the patients participating in the PK study.|Initial PK assessment (Day -1) and 6 months||||IU/dL||Standard Deviation|Mean
2544879|NCT02953678|Secondary|Three-month Duration of Response (DOR)||From baseline to 84 days|||||||
2544880|NCT02953678|Secondary|Overall Response Rate (ORR)|Defined as the percentage of participants demonstrating a CR, VGPR, or PR.|From baseline to days 14, 56, and 100|||||||
2544811|NCT02954575|Secondary|Pharmacokinetic (PK) Assessment (in Vivo Half-Life (t1/2)) of FVIII:C|PK assessments of FVIII:C were conducted using the one-stage (OS) assay. The in vivo half-life of FVIII:C was calculated based on the FVIII:C values measured in the patients participating in the PK study.|Initial PK assessment (Day -1) and PK study completion visit (6 months); data collected 1 h prior to infusion and 15 min, 1 h, 3 h, 6 h, 9 h, 24 h, 30 h and 48 h after the end of injection||||Hours||Standard Deviation|Mean
2544812|NCT02954575|Secondary|Pharmacokinetic (PK) Assessment (Area Under the Curve [AUC] Norm) of FVIII:C|PK assessments of FVIII:C were conducted using the one-stage (OS) assay. The value of the AUCnorm of FVIII:C was calculated based on the FVIII:C values measured in the patients participating in the PK study.|Initial PK visit (Day -1) and PK study completion visit (6 months); data collected 1 h prior to injection and 15 min, 1 h, 3 h, 6 h, 9 h, 24 h, 30 h and 48 h after the end of injection|AUC divided by dose (IU*h/dL per IU/kg)|||IU*h/dL per IU/kg||Standard Deviation|Mean
2544813|NCT02954575|Secondary|Wilate Consumption Data (Average Total Normdose of FVIII IU/kg Per Month of Study) for Prophylaxis|The average consumption of Wilate per month of study (IU/kg) for all patients receiving prophylaxis.|6 months||||IU/kg||Standard Deviation|Mean
2544814|NCT02954575|Secondary|Efficacy of Wilate in the Treatment of Breakthrough BEs|"The proportion of BEs successfully treated with Wilate were documented by the patient (together with the investigator in case of on-site treatments) in the patient diary for all BEs according to a 4-point hemostatic efficacy scale including the four items: 'excellent,' 'good,' moderate,' and 'none', where 'excellent' was defined as Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single injection (best outcome) and 'none' was defined as No improvement within 12 hours, or worsening of symptoms, requiring more than two injections for complete resolution (worst outcome). All efficacy ratings assessed as either 'excellent' or 'good' were considered 'successfully treated.'"|6 months|In the PP population, efficacy of Wilate in the treatment of breakthrough BEs was analyzed for all patients experiencing breakthrough BEs (N=24)|||Number of BEs|Number of BEs||Count of Units
2544815|NCT02954575|Secondary|Spontaneous Annualized Bleeding Rate (SABR)|The number of spontaneous bleeding events (BEs) was documented by patients in a patient diary (together with the investigator in case of on-site treatments), which was reviewed at each follow-up visit by site personnel.|6 months|The spontaneous annualized bleeding rate (SABR) was calculated for all patients included in the PP population (N=52).|||No. of spontaneous BEs/year (SABR)|No. of BEs|Standard Deviation|Mean
2544816|NCT02954575|Primary|Total Annualized Bleeding Rate (TABR)|The total number of bleeding events (BEs) was documented by patients in a patient diary (together with the investigator in case of on-site treatments), which was reviewed at each follow-up visit by site personnel.|6 months|The total annualized bleeding rate (TABR) was calculated for all patients included in the PP population (N=52).|||No. of BEs / year (ABR)|No. of Bleeding Episodes (BEs)|Standard Deviation|Mean
2544817|NCT02954354|Secondary|Percentage of Participants With Adverse Events (AEs)||From first dose of study drug to Day 22|All participants who received at least 1 dose of study drug|||percentage of participants|||Number
2544818|NCT02954354|Secondary|Percentage of Participants With Influenza-related Complications in Adults Randomized to Baloxavir or Oseltamivir|The percentage of participants who experienced each influenza-related complication (hospitalization, death, sinusitis, otitis media, bronchitis, and radiologically confirmed pneumonia) as an adverse event after the initiation of the study treatment.|Initiation of study treatment up to Day 14|Participants in the intention-to-treat infection population ≥ 20 years of age and assigned to baloxavir or oseltamivir.|||percentage of participants||95% Confidence Interval|Number
2544819|NCT02954354|Secondary|Percentage of Participants With Influenza-related Complications in Participants Randomized to Baloxavir or Placebo|The percentage of participants who experienced each influenza-related complication (hospitalization, death, sinusitis, otitis media, bronchitis, and radiologically confirmed pneumonia) as an adverse event after the initiation of the study treatment.|Initiation of study treatment up to Day 14|Participants in the intention-to-treat infection population assigned to baloxavir or placebo|||percentage of participants||95% Confidence Interval|Number
2544820|NCT02954354|Secondary|Time to Return to Preinfluenza Health Status in Adults Randomized to Baloxavir or Oseltamivir|"Participants were asked to record their preinfluenza health status on a scale from 0 (worst possible health) to 10 (normal health [for someone your age and your health condition]), and their health status every day after initiation of study treatment on the same scale. Return to preinfluenza health status was defined as time from the initiation of the study treatment to the first time when the health status score was equal to or higher than the preinfluenza health status score.~Time to return to preinfluenza health status was analyzed using KM methods; participants with a smaller number on the scale for health status by the last observation time point were censored at that time point."|Initiation of study treatment up to Day 14|Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, whose health status score at baseline was lower than the preinfluenza health status score and with available time to return to preinfluenza health status data.|||hours||95% Confidence Interval|Median
2544821|NCT02954354|Secondary|Time to Return to Preinfluenza Health Status in Participants Randomized to Baloxavir or Placebo|"Participants were asked to record their preinfluenza health status on a scale from 0 (worst possible health) to 10 (normal health [for someone your age and your health condition]), and their health status every day after initiation of study treatment on the same scale. Return to preinfluenza health status was defined as time from the initiation of the study treatment to the first time when the health status score was equal to or higher than the preinfluenza health status score.~Time to return to preinfluenza health status was analyzed using KM methods; participants with a smaller number on the scale for health status by the last observation time point were censored at that time point."|Initiation of study treatment up to Day 14|Participants in the intention-to-treat infection population assigned to baloxavir or placebo whose health status score at baseline was lower than the preinfluenza health status score and with available time to return to preinfluenza health status data.|||hours||95% Confidence Interval|Median
2544857|NCT02954198|Other Pre-specified|Subject Specific Change on Medication Side Effect Scale|Examine subject specific change on a validated Medication Side Effect Scale at the time of the conversion versus six months post-conversion, compared between the two arms. Side effect burden scale is from 0 to 180. A lower score is less side effect burden, a higher score is more side effect burden.|Baseline to 6 months post conversion||||units on a scale||Standard Deviation|Mean
2544822|NCT02954354|Secondary|Time to Alleviation of Individual Symptoms in Adults Randomized to Baloxavir or Oseltamivir|"Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).~Time to alleviation of each symptom was defined as the time from the start of treatment to the start of the time period when the individual symptom was assessed by the participant as 0 (None) or 1 (Mild) for a duration of at least 21.5 hours."|Initiation of study treatment up to Day 14|Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, whose symptom score at baseline was moderate (2) or severe (3) with available time to alleviation of symptoms data.|||hours||95% Confidence Interval|Median
2544823|NCT02954354|Secondary|Time to Alleviation of Individual Symptoms in Participants Randomized to Baloxavir or Placebo|"Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).~Time to alleviation of each symptom was defined as the time from the start of treatment to the start of the time period when the individual symptom was assessed by the participant as 0 (None) or 1 (Mild) for a duration of at least 21.5 hours."|Initiation of study treatment up to Day 14|Participants in the intention-to-treat infection population assigned to baloxavir or placebo whose symptom score at baseline was moderate (2) or severe (3) with available time to alleviation of symptoms data.|||hours||95% Confidence Interval|Median
2544824|NCT02954354|Secondary|Body Temperature at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir|Participant's self-measured axillary temperature using an electronic thermometer.|12, 24, 36, 48, 72, 96 and 120 hours after the initial dose of study treatment|Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, with available temperature data at each time point.|||°C||Standard Error|Least Squares Mean
2544825|NCT02954354|Secondary|Body Temperature at Each Time Point in Participants Randomized to Baloxavir or Placebo|Participant's self-measured axillary temperature using an electronic thermometer.|12, 24, 36, 48, 72, 96 and 120 hours after the initial dose of study treatment|Participants in the intention-to-treat infection population assigned to baloxavir or placebo with available temperature data at each time point.|||°C||Standard Error|Least Squares Mean
2544826|NCT02954354|Secondary|Percentage of Participants Reporting Normal Temperature at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir|Defined as the percentage of patients whose axillary temperature dropped to less than 37ºC after the initiation of study treatment.|12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216 hours after the initial dose of study treatment|Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, whose body temperature at baseline was more than 37°C with available body temperature data at each time point.|||percentage of participants||95% Confidence Interval|Number
2544827|NCT02954354|Secondary|Percentage of Participants Reporting Normal Temperature at Each Time Point in Participants Randomized to Baloxavir or Placebo|Defined as the percentage of patients whose axillary temperature dropped to less than 37ºC after the initiation of study treatment.|12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216 hours after the initial dose of study treatment|Participants in the intention-to-treat infection population assigned to baloxavir or placebo whose body temperature at baseline was more than 37°C with available body temperature data at each time point.|||percentage of participants||95% Confidence Interval|Number
2544828|NCT02954354|Secondary|Time to Resolution of Fever in Adults Randomized to Baloxavir or Oseltamivir|"Time to resolution of fever was defined as the time between the initiation of the study treatment and the resolution of fever. The resolution of fever was defined as the time when the participant's self-measured axillary temperature became less than 37ºC and was maintained at less than 37ºC for a duration of at least 12 hours.~Time to resolution of fever was analyzed using KM methods; participants who did not experience resolution of fever by the last observation time point were censored at that time point."|Initiation of study treatment up to Day 14|Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, whose body temperature at baseline was more than 37°C and time to resolution of fever was not missing.|||hours||95% Confidence Interval|Median
2544829|NCT02954354|Secondary|Time to Resolution of Fever in Participants Randomized to Baloxavir or Placebo|"Time to resolution of fever was defined as the time between the initiation of the study treatment and the resolution of fever. The resolution of fever was defined as the time when the participant's self-measured axillary temperature became less than 37ºC and was maintained at less than 37ºC for a duration of at least 12 hours.~Time to resolution of fever was analyzed using KM methods; participants who did not experience resolution of fever by the last observation time point were censored at that time point."|Initiation of study treatment up to Day 14|Participants in the intention-to-treat infection population assigned to baloxavir or placebo whose body temperature at baseline was more than 37°C and time to resolution of fever was not missing.|||hours||95% Confidence Interval|Median
2544830|NCT02954354|Secondary|Change From Baseline in Composite Symptom Score at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir|"Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).~The composite symptom score is the total score of the 7 influenza symptoms as assessed by the participant, and ranges from 0 to 21."|Day 1 pretreatment (Baseline) and 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, and 216 hours after the initial dose of study treatment.|Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, with available composite symptom scores at Baseline and each time point.|||scores on a scale||Standard Error|Least Squares Mean
2544858|NCT02954198|Secondary|Percent of Participants Experiencing Acute Allograft Rejection|Estimate the composite of treatment failure rate, defined as acute allograft rejection with a Banff grade 1A or higher, graft loss, or death at six months post-conversion, in patients converted to a once-daily immunosuppressant regimen of Envarsus®, everolimus, and prednisone versus patients converted to a twice-daily regimen of Envarsus®, MMF, and prednisone.|Baseline to 6 months post conversion||||Participants|||Count of Participants
2544831|NCT02954354|Secondary|Change From Baseline in Composite Symptom Score at Each Time Point in Participants Randomized to Baloxavir or Placebo|"Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).~The composite symptom score is the total score of the 7 influenza symptoms as assessed by the participant, and ranges from 0 to 21."|Day 1 pretreatment (Baseline) and 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, and 216 hours after the initial dose of study treatment.|Participants in the intention-to-treat infection population assigned to baloxavir or placebo with available composite symptom scores at Baseline and each time point.|||scores on a scale||Standard Error|Least Squares Mean
2544832|NCT02954354|Secondary|Time to Alleviation of the Three Respiratory Symptoms in Adults Randomized to Baloxavir or Oseltamivir|"Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms). Time to alleviation of the 3 respiratory symptoms was defined as the time from the start of study treatment to the time when all 3 respiratory symptoms (cough, sore throat and nasal congestion) were assessed by the participant as absent (0) or mild (1) for at least 21.5 hours.~Time to alleviation of the 3 respiratory symptoms was analyzed using the KM method; participants who did not experience alleviation of symptoms were censored at the last observation time point."|Initiation of study treatment up to Day 14|Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, with available time to alleviation of the 3 respiratory symptoms data.|||hours||95% Confidence Interval|Median
2544833|NCT02954354|Secondary|Time to Alleviation of the Three Respiratory Symptoms in Participants Randomized to Baloxavir or Placebo|"Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms). Time to alleviation of the 3 respiratory symptoms was defined as the time from the start of study treatment to the time when all 3 respiratory symptoms (cough, sore throat and nasal congestion) were assessed by the participant as absent (0) or mild (1) for at least 21.5 hours.~Time to alleviation of the 3 respiratory symptoms was analyzed using the KM method; participants who did not experience alleviation of symptoms were censored at the last observation time point."|Initiation of study treatment up to Day 14|Participants in the intention-to-treat infection population assigned to baloxavir or placebo with available time to alleviation of the 3 respiratory symptoms data.|||hours||95% Confidence Interval|Median
2544834|NCT02954354|Secondary|Time to Alleviation of the Four Systemic Symptoms in Adults Randomized to Baloxavir or Oseltamivir|"Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).~Time to alleviation of the 4 systemic symptoms was defined as the time between the initiation of the study treatment to the time when all 4 systemic symptoms (headache, feverishness or chills, muscle or joint pain, and fatigue) were assessed by the participant as 0 (None) or 1 (Mild) for a duration of at least 21.5 hours.~Time to alleviation of the 4 systemic symptoms was analyzed using KM methods; participants who did not experience alleviation of symptoms were censored at the last observation time point."|Initiation of study treatment up to Day 14|Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, with available time to alleviation of the 4 systemic symptoms data.|||hours||95% Confidence Interval|Median
2544835|NCT02954354|Secondary|Time to Alleviation of the Four Systemic Symptoms in Participants Randomized to Baloxavir or Placebo|"Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).~Time to alleviation of the 4 systemic symptoms was defined as the time between the initiation of the study treatment to the time when all 4 systemic symptoms (headache, feverishness or chills, muscle or joint pain, and fatigue) were assessed by the participant as 0 (None) or 1 (Mild) for a duration of at least 21.5 hours.~Time to alleviation of the 4 systemic symptoms was analyzed using KM methods; participants who did not experience alleviation of symptoms were censored at the last observation time point."|Initiation of study treatment up to Day 14|Participants in the intention-to-treat infection population assigned to baloxavir or placebo with available time to alleviation of the 4 systemic symptoms data.|||hours||95% Confidence Interval|Median
2544836|NCT02954354|Secondary|Percentage of Participants Whose Symptoms Were Alleviated at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir|Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms). Alleviation of symptoms was defined as all seven influenza-related symptoms assessed by the participant as absent (0) or mild (1) .|12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216 hours after the initial dose of study treatment|Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, with available alleviation of symptoms data at each time point.|||percentage of participants||95% Confidence Interval|Number
2544837|NCT02954354|Secondary|Percentage of Participants Whose Symptoms Were Alleviated at Each Time Point in Participants Randomized to Baloxavir or Placebo|Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms). Alleviation of symptoms was defined as all seven influenza-related symptoms assessed by the participant as absent (0) or mild (1) .|12, 24, 36, 48, 72, 96, 120, 144, 168, 192 and 216 hours after the initial dose of study treatment|Participants in the intention-to-treat infection population assigned to baloxavir or placebo with available alleviation of symptoms data at each time point.|||percentage of participants||95% Confidence Interval|Number
2544876|NCT02953678|Secondary|Relapse-related Mortality Rate|Defined as the percentage of participants whose malignancy relapsed and had a fatal outcome.|From baseline to Day 84|Efficacy Evaluable Participants|||percentage of participants||95% Confidence Interval|Number
2544838|NCT02954354|Secondary|Time to Cessation of Viral Shedding Determined by Virus RNA in Adults Randomized to Baloxavir or Oseltamivir|"Time to cessation of viral shedding by RT-PCR was defined as the time between the initiation of the study treatment and first time when the virus RNA was below the limit of detection measured by RT-PCR.~Time to cessation of viral shedding by RT-PCR was analyzed using the KM method; participants whose virus RNA had not reached cessation by the last observation time point were treated as censored at that time point."|Day 1 to Day 9|Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, with positive influenza virus RNA determined by RT-PCR on Day 1 whose time to cessation of viral shedding by RTPCR was not missing were included in this analysis.|||hours||95% Confidence Interval|Median
2544839|NCT02954354|Secondary|Time to Cessation of Viral Shedding Determined by Virus RNA in Participants Randomized to Baloxavir or Placebo|"Time to cessation of viral shedding by RT-PCR was defined as the time between the initiation of the study treatment and first time when the virus RNA was below the limit of detection measured by RT-PCR.~Time to cessation of viral shedding by RT-PCR was analyzed using the KM method; participants whose virus RNA had not reached cessation by the last observation time point were treated as censored at that time point."|Day 1 to Day 9|Participants in the intention-to-treat infection population assigned to baloxavir or placebo, with positive influenza virus RNA determined by RT-PCR on Day 1 whose time to cessation of viral shedding by RTPCR was not missing were included in this analysis.|||hours||95% Confidence Interval|Median
2544840|NCT02954354|Secondary|Time to Cessation of Viral Shedding Determined by Virus Titer in Adults Randomized to Baloxavir or Oseltamivir|Time to cessation of viral shedding by virus titer was defined as the time between the initiation of the study treatment and first time when the virus titer was below the limit of detection (0.7 log₁₀[TCID₅₀/mL]). The time to cessation of viral shedding determined by virus titer was analyzed using the Kaplan-Meier (KM) method; participants whose virus titer had not reached cessation by the last observation time point were treated as censored at that time point.|Day 1 to Day 9|Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, with a positive virus titer on Day 1 whose time to cessation of viral shedding by virus titer was not missing..|||hours||95% Confidence Interval|Median
2544841|NCT02954354|Secondary|Time to Cessation of Viral Shedding Determined by Virus Titer in Participants Randomized to Baloxavir or Placebo|Time to cessation of viral shedding by virus titer was defined as the time between the initiation of the study treatment and first time when the virus titer was below the limit of detection (0.7 log₁₀[TCID₅₀/mL]). The median and 95% confidence interval (CI) for time to cessation of viral shedding determined by virus titer was analyzed using the Kaplan-Meier (KM) method; participants whose virus titer had not reached cessation by the last observation time point were treated as censored at that time point.|Day 1 to Day 9|Participants in the intention-to-treat infection population assigned to baloxavir or placebo with a positive virus titer on Day 1 whose time to cessation of viral shedding by virus titer was not missing were included in this analysis.|||hours||95% Confidence Interval|Median
2544842|NCT02954354|Secondary|Area Under the Curve (AUC) Adjusted by Baseline of Influenza Virus RNA in Adults Randomized to Baloxavir or Oseltamivir|This endpoint was defined as AUC of change from baseline in the amount of virus RNA (RT-PCR) from Day 1 to Day 9. The AUC was calculated using the trapezoidal method.|Day 1 to Day 9|Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, with a positive virus RNA determined by RT-PCR at baseline and available sample on Day 9.|||log₁₀ virus particles/mL*hours||Standard Deviation|Mean
2544843|NCT02954354|Secondary|Area Under the Curve (AUC) Adjusted by Baseline of Influenza Virus RNA in Participants Randomized to Baloxavir or Placebo|This endpoint was defined as AUC of change from baseline in the amount of virus RNA (RT-PCR) from Day 1 to Day 9. The AUC was calculated using the trapezoidal method.|Day 1 to Day 9|Participants in the intention-to-treat infection population assigned to baloxavir or placebo with a positive virus RNA determined by RT-PCR at baseline and available sample on Day 9.|||log₁₀ virus particles/mL*hours||Standard Deviation|Mean
2544844|NCT02954354|Secondary|Area Under the Curve (AUC) Adjusted by Baseline in Influenza Virus Titer in Adults Randomized to Baloxavir or Oseltamivir|This endpoint was defined as AUC of change from Baseline in virus titer from Day 1 to Day 9. AUC was calculated using the trapezoidal method.|Day 1 to Day 9|Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, with a positive virus titer on Day 1 and available sample on Day 9.|||log₁₀[TCID₅₀/mL]*hours||Standard Deviation|Mean
2544845|NCT02954354|Secondary|Area Under the Curve (AUC) Adjusted by Baseline in Influenza Virus Titer in Participants Randomized to Baloxavir or Placebo|This endpoint was defined as AUC of change from Baseline in virus titer from Day 1 to Day 9. AUC was calculated using the trapezoidal method.|Day 1 to Day 9|Participants in the intention-to-treat infection population assigned to baloxavir or placebo, with a positive virus titer on Day 1 and available sample on Day 9.|||log₁₀[TCID₅₀/mL]*hours||Standard Deviation|Mean
2544846|NCT02954354|Secondary|Change From Baseline in Virus RNA (RT-PCR) at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir|Nasopharyngeal swabs (or throat swabs, if nasopharyngeal swabbing was not feasible) were obtained for viral quantitation. Virus RNA was measured by reverse transcription polymerase chain reaction (RT-PCR).|Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9|Participants in the intention-to-treat infection population ≥ 20 years of age and assigned to baloxavir or oseltamivir, with positive influenza virus titer on Day 1 and with available virus RNA data at each time point.|||log₁₀ virus particles/mL||Standard Deviation|Mean
2544847|NCT02954354|Secondary|Change From Baseline in Virus RNA (RT-PCR) at Each Time Point in Participants Randomized to Baloxavir or Placebo|Nasopharyngeal swabs (or throat swabs, if nasopharyngeal swabbing was not feasible) were obtained for viral quantitation. Virus RNA is measured by reverse transcription polymerase chain reaction (RT-PCR).|Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9|Participants in the intention-to-treat infection population assigned to baloxavir or placebo, with positive influenza virus titer on Day 1 and with available virus RNA data at each time point.|||log₁₀ virus particles/mL||Standard Deviation|Mean
2544877|NCT02953678|Secondary|Relapse Rate|Defined as the percentage of participants whose underlying malignancy relapsed.|From baseline to Day 84|Efficacy Evaluable Participants|||percentage of participants||95% Confidence Interval|Number
2544848|NCT02954354|Secondary|Change From Baseline in Virus Titer at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir|"Virus titer was quantified from nasopharyngeal swabs (or throat swabs if nasopharyngeal swabbing was not feasible) by tissue culture methods.~If virus titer was less than the lower limit of quantification, the virus titer was imputed 0.7 (TCID₅₀/mL)."|Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9|Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, with positive influenza virus titer on Day 1 and with available virus titer data at each time point.|||log₁₀[TCID₅₀/mL]||Standard Deviation|Mean
2544849|NCT02954354|Secondary|Change From Baseline in Virus Titer at Each Time Point in Participants Randomized to Baloxavir or Placebo|"Virus titer was quantified from nasopharyngeal swabs (or throat swabs if nasopharyngeal swabbing was not feasible) by tissue culture methods.~If virus titer was less than the lower limit of quantification, the virus titer was imputed 0.7 (TCID₅₀/mL)."|Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9|Participants in the intention-to-treat infection population assigned to baloxavir or placebo, with positive influenza virus titer on Day 1 and with available virus titer data at each time point.|||log₁₀[TCID₅₀/mL]||Standard Deviation|Mean
2544850|NCT02954354|Secondary|Percentage of Participants With Positive Influenza Virus by RT-PCR at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir|Influenza virus RNA was quantified from nasopharyngeal swabs (or throat swabs, if nasopharyngeal swabbing was not feasible). The percentage of participants with detectable virus RNA (2.05 for flu A and 2.83 for flu B log₁₀ virus particles/mL) among those assessed measured by reverse transcription polymerase chain reaction (RT-PCR) on Days 2, 3, 4, 5, 6 and 9.|Days 2, 3, 4 (optional), 5, 6 (optional), and 9|Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, with positive influenza virus RNA determined by RT-PCR on Day 1, and with available data at each time point were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2544851|NCT02954354|Secondary|Percentage of Participants With Positive Influenza Virus by RT-PCR at Each Time Point in Participants Randomized to Baloxavir or Placebo|Influenza virus ribonucleic acid (RNA) was quantified from nasopharyngeal swabs (or throat swabs, if nasopharyngeal swabbing was not feasible). The percentage of participants with detectable virus RNA (2.05 for flu A and 2.83 for flu B log₁₀ virus particles/mL) among those assessed measured by reverse transcription polymerase chain reaction (RT-PCR) on Days 2, 3, 4, 5, 6 and 9.|Days 2, 3, 4 (optional), 5, 6 (optional), and 9|Participants in the intention-to-treat infection population assigned to baloxavir or placebo, with positive influenza virus RNA determined by RT-PCR on Day 1 and with available data at each time point were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2544852|NCT02954354|Secondary|Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Adults Randomized to Baloxavir or Oseltamivir|Virus titer was quantified from nasopharyngeal swabs (or throat swabs if nasopharyngeal swabbing was not feasible) by tissue culture methods. Positive influenza virus titer was defined as virus titer not less than the lower limit of quantification (0.7 log₁₀ of the 50% tissue culture infective dose (TCID₅₀/mL) among those assessed for virus titer on Days 2, 3, 4, 5, 6 and 9.|Days 2, 3, 4 (optional), 5, 6 (optional), and 9|Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, with positive influenza virus titer on Day 1 and with available virus titer data at each time point.|||percentage of participants||95% Confidence Interval|Number
2544853|NCT02954354|Secondary|Percentage of Participants With Positive Influenza Virus Titer at Each Time Point in Participants Randomized to Baloxavir or Placebo|Virus titer was quantified from nasopharyngeal swabs (or throat swabs if nasopharyngeal swabbing was not feasible) by tissue culture methods. Positive influenza virus titer was defined as virus titer not less than the lower limit of quantification (0.7 log₁₀ of the 50% tissue culture infective dose (TCID₅₀/mL) among those assessed for virus titer on Days 2, 3, 4, 5, 6 and 9.|Days 2, 3, 4 (optional), 5, 6 (optional), and 9|Participants in the intention-to-treat infection population assigned to baloxavir or placebo, with positive influenza virus titer on Day 1 and with available virus titer data at each time point.|||percentage of participants||95% Confidence Interval|Number
2544854|NCT02954354|Primary|Time to Alleviation of Symptoms in Adults Randomized to Baloxavir or Oseltamivir|"Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).~Time to alleviation of symptoms was defined as the time from the start of the study treatment to the time when all seven influenza-related symptoms were assessed by the participant as absent (0) or mild (1) for at least 21.5 hours.~Time to alleviation of symptoms was analyzed using the Kaplan-Meier(KM) method; participants who did not experience alleviation of symptoms were censored at the last observation time point."|Initiation of study treatment up to Day 14|Participants in the intention-to-treat infection population, ≥ 20 years of age and assigned to baloxavir or oseltamivir, and with available time to alleviation of symptoms data.|||hours||95% Confidence Interval|Median
2544855|NCT02954354|Primary|Time to Alleviation of Symptoms in Participants Randomized to Baloxavir or Placebo|"Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).~Time to alleviation of symptoms was defined as the time from the start of the study treatment to the time when all seven influenza-related symptoms were assessed by the participant as absent (0) or mild (1) for at least 21.5 hours.~Time to alleviation of symptoms was analyzed using the Kaplan-Meier (KM) method; participants who did not experience alleviation of symptoms were censored at the last observation time point."|Initiation of study treatment up to Day 14|Participants in the intention-to-treat infection population assigned to baloxavir or placebo with available time to alleviation of symptoms data.|||hours||95% Confidence Interval|Median
2544856|NCT02954198|Other Pre-specified|Percent of Participants Who Experienced Kidney Transplant Graft Loss|Measure and compare time-to-event analysis between the two arms graft loss (time to event analysis)|Baseline to 6 months post conversion||||Participants|||Count of Participants
2547283|NCT02909140|Secondary|Mean Time Taken to Perform Phacoemulsification||During cataract surgery|"Data was only collected for the Intracameral Mydriasis' arm We analyzed data for 1 participant only because of lack of data for the other participant."|||seconds|||Number
2544859|NCT02954198|Primary|Self-reported Medication Adherence From Baseline to 6 Months.|Percent of subjects reporting high medication adherence at baseline compared to 6 months post-conversion, using the Morisky Medication Adherence scale (MMAS). The MMAS rates medication adherence on a scale of 0 to 8. 0 is high adherence, 1-2 is medium adherence, and greater than or equal to 3 is low adherence.|6 months post conversion||||% of participants|||Number
2544860|NCT02953938|Secondary|The Mean Change in Change in Central Subfield Foveal Thickness (CSFT) From Month 1 Through Month 12 Compared to Baseline (Day1) by the Treatment Arms|The mean change in investigator-assessed CSFT from Month 1 through Month 12 was compared to Baseline (Day1) by the treatment arms. The analyses at each visit was based on an analysis of variance (ANOVA) model as analogous to BCVA. The analyses was conducted within the FAS using the Last-Observation-Carried-Forward (LOCF) approach|Month 1 through Month 12|Full Analysis Set (FAS)|||mm||Standard Deviation|Mean
2544861|NCT02953938|Secondary|BCVA (Letters) Number and Proportion of Patients With a BCVA Improvement vs. Baseline, Loss Less Than 15 Letters, or Attainment of Greater Than or Equal to 85 Letters at Month 6 and at Month 12 in the Study Eye|"Endpoints related to the number and proportion of patients with BCVA letter gain or loss from Baseline (Day1) was analyzed via stratified CMH test with stratification factors as described in primary model. The mean (SD) average (per patient) BCVA (logMAR) change from Baseline through Month 12~Summary of BCVA (logMAR) mean average change from Baseline from Month 1 through Month 12 in the study eye"|Month 6 and Month 12|Full Analysis Set (FAS) consisted of all randomized patients who received at least one administration of ranibizumab injection|||Participants|||Count of Participants
2544862|NCT02953938|Secondary|The Mean Change in BCVA From Month 1 Through Month 12 Compared to Baseline (Day 1) by the Treatment Arms|Summary of BCVA (logMAR) absolute value and change from Baseline at Month 12 in the study eye - full analysis set (LOCF) was based on an analysis of variance (ANOVA) model with treatment group, and stratification factors. Stratification was based on baseline visual acuity (< 0.52, >= 0.52). The analyses was conducted within the FAS using the LOCF approach|Month 1 through Month 12|FAS|||logMAR||Standard Deviation|Mean
2544863|NCT02953938|Secondary|The Mean Change in Best Corrected Visual Acuity (BCVA) Using Decimal Chart and Early Treatment Diabetic Retinopathy Study (ETDRS) Compared to Baseline|"Summary of BCVA (letters) absolute value and change from Baseline at Month 12 in the study eye - full analysis set (LOCF) was based on an analysis of variance (ANOVA) model with treatment group, and stratification factors. Stratification was done based on categories of baseline decimal VA (<0.3, or =>0.3). The analyses was conducted within the FAS using the LOCF approach~Stratification was based on baseline visual acuity on logMAR scale (<0.52, >=0.52). Test was one-sided."|Month 1 through Month 12 (for ETDRS: Month 6 and Month 12)|The Full Analysis Set (FAS) consisted of all randomized patients who received at least one administration of ranibizumab injection.|||letters read correctly||Standard Deviation|Mean
2544864|NCT02953938|Primary|Difference in Mean Number of Ranibizumab Injections|"Number of ranibizumab treatments from Day 1 to Month 11 using full analysis set (observed) based on a stratified Cochran-Mantel-Haenszel (CMH) test. Stratification was done based on categories of baseline decimal VA (<0.3, or =>0.3). Difference of mean number of injections, 95% confidence interval (CI) of difference and one-sided p-value of the CMH test was reported. Analysis was conducted within the FAS with observed data.~Stratification was based on baseline visual acuity on logMAR scale (<0.52, >=0.52). Test was one-sided."|Month 1 through Month 12|Randomized Set, i.e.; all randomized patients.|||number of injections||Standard Deviation|Mean
2544865|NCT02953886|Secondary|Patient Assessment of Appearance of Treated Tooth (Concern With the Appearance of Study Tooth, Desire for the Study Tooth to be Filled)|Each subject was asked if they were concerned with the appearance of the tooth that SDF was applied too. They were also asked if they wanted the study tooth to be filled with a tooth color filling.|One month||||Participants|||Count of Participants
2544866|NCT02953886|Primary|Caries Arrest of Teeth Measured by Change in Dentin Texture (Soft, Hard)|Caries were examined for hardness or softness before and after SDF application. The change in the texture was examined after one month of SDF application the change from soft to hard is noted below.|One month||||cervical lesions|||Number
2544867|NCT02953886|Primary|Change in Bacterial Composition Before and One Month After SDF Application to Root or Cervical Caries Lesions|Using human oral microbiome identification using next-generation sequencing (HOMINGS), change in the total bacterial composition of all subjects was measured by the difference of the number of bacteria count from baseline to one month after SDF application.|baseline, One month after SDF||||bacterial count|||Number
2544868|NCT02953873|Secondary|Dose Modifications|Number of dose modifications from baseline to 3 months post-conversion.|Baseline to 3 months post conversion|12 participants are homozygous, 10 are heterozygous, and 3 are non-expressors. This represents the 25 total subjects in the study.|||number of dose modifications||Inter-Quartile Range|Median
2544869|NCT02953873|Secondary|Number of Days to Reach Therapeutic Trough Goal|Days to reach therapeutic goal after conversion|Baseline to 3 months post conversion|Days to reach therapeutic goal was further separated by CYP3A5 1 expression.|||number of days||Inter-Quartile Range|Median
2544870|NCT02953873|Secondary|Weight-Based Dose Requirement|Weight-based dose requirements to reach therapeutic goal pre- and post-conversion|Baseline to 3 months post conversion||||mg/kg||Inter-Quartile Range|Median
2544871|NCT02953873|Secondary|Total Daily Dose|Difference in Total Daily Dose necessary for steady state therapeutic goal|Baseline to 3 months post conversion||||mg||Inter-Quartile Range|Median
2544872|NCT02953873|Primary|Dose-normalized Trough|Difference in dose-normalized trough at steady state before and after conversion from tacrolimus IR to Astagraf XL®|Baseline to 3 months post-conversion||||ng/dL||Inter-Quartile Range|Median
2544873|NCT02953678|Secondary|Incidence and Severity of Adverse Events||From consent to 30-35 days after end of treatment, up to 24 months|||||||
2544874|NCT02953678|Secondary|Overall Survival (OS)|Defined as the time from study enrollment (first day of ruxolitinib treatment) to death due to any cause.|From baseline to Day 84|Efficacy Evaluable Participants: Participants who had CR, VGPR, or PR on or before the start of new anti-GVHD therapy.|||days||95% Confidence Interval|Median
2544875|NCT02953678|Secondary|Failure-free Survival (FFS)|Defined as the time from first dose of ruxolitinib to the earliest date that a participant died, had a relapse/progression of the underlying malignancy, required additional therapy for aGVHD, or demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD).|From baseline to Day 84|Efficacy Evaluable Participants|||days||95% Confidence Interval|Median
2544881|NCT02953678|Secondary|Six-month Duration of Response (DOR)|Defined as the time from first response until graft-versus-host disease (GVHD) progression or death. DOR was assessed when all participants who were still on study completed the Day 180 visit.|From baseline to Day 180|||||||
2544882|NCT02953678|Primary|Overall Response Rate (ORR) at Day 28|Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).|From baseline to Day 28|Efficacy Evaluable Participants who had a CR, VGPR, or PR at Day 28 response assessment or other response assessments within ± 2 days of Day 28, on or before the start of new anti-GVHD therapy|||Participants|||Count of Participants
2544883|NCT02953314|Secondary|Part B: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|From Baseline through Week 24|FAS: participants who carry the intended CFTR mutations and received at least 1 dose of study drug. The aim of weight based dosing is to achieve similar exposures in children of different weights, thus the planned analysis is presented for the single treatment arm irrespective of weight-based dosing regimen.|||units on a scale||95% Confidence Interval|Least Squares Mean
2544884|NCT02953314|Secondary|Part B: Absolute Change in Sweat Chloride|Sweat samples were collected using an approved collection device.|From Baseline through Week 24|FAS: participants who carry the intended CFTR mutations and received at least 1 dose of study drug. The aim of weight based dosing is to achieve similar exposures in children of different weights, thus the planned analysis is presented for the single treatment arm irrespective of weight-based dosing regimen.|||mmol/L||95% Confidence Interval|Least Squares Mean
2544885|NCT02953314|Secondary|Part B: Absolute Change in Sweat Chloride|Sweat samples were collected using an approved collection device.|From Baseline through Week 4|FAS: participants who carry the intended CFTR mutations and received at least 1 dose of study drug. The aim of weight based dosing is to achieve similar exposures in children of different weights, thus the planned analysis is presented for the single treatment arm irrespective of weight-based dosing regimen.|||millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2544886|NCT02953314|Secondary|Part B: Absolute Change in BMI-for-age z-Score|BMI was defined as weight in kg divided by height in m^2. z-score is a statistical measure to describe whether a mean was above or below the standard. BMI, adjusted for age and sex, was analyzed as BMI-for-age z-score. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of higher BMI.|From Baseline at Week 24|FAS: participants who carry the intended CFTR mutations and received at least 1 dose of study drug. The aim of weight based dosing is to achieve similar exposures in children of different weights, thus the planned analysis is presented for the single treatment arm irrespective of weight-based dosing regimen.|||z-score||95% Confidence Interval|Least Squares Mean
2544887|NCT02953314|Secondary|Part B: Absolute Change in Body Mass Index (BMI)|BMI was defined as weight in kg divided by height in square meter (m^2).|From Baseline at Week 24|FAS: participants who carry the intended CFTR mutations and received at least 1 dose of study drug. The aim of weight based dosing is to achieve similar exposures in children of different weights, thus the planned analysis is presented for the single treatment arm irrespective of weight-based dosing regimen.|||kg/m^2||95% Confidence Interval|Least Squares Mean
2544888|NCT02953314|Secondary|Part B: Absolute Change in Height-for-age z-Score|z-score is a statistical measure to describe whether a mean was above or below the standard. Height, adjusted for age and sex, was analyzed as height-for-age z-score. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of higher height.|From Baseline at Week 24|FAS: participants who carry the intended CFTR mutations and received at least 1 dose of study drug. The aim of weight based dosing is to achieve similar exposures in children of different weights, thus the planned analysis is presented for the single treatment arm irrespective of weight-based dosing regimen.|||z-score||95% Confidence Interval|Least Squares Mean
2544889|NCT02953314|Secondary|Part B: Absolute Change in Height||From Baseline at Week 24|FAS: participants who carry the intended CFTR mutations and received at least 1 dose of study drug. The aim of weight based dosing is to achieve similar exposures in children of different weights, thus the planned analysis is presented for the single treatment arm irrespective of weight-based dosing regimen.|||centimeter (cm)||95% Confidence Interval|Least Squares Mean
2544890|NCT02953314|Secondary|Part B: Absolute Change in Weight-for-age Z-Score|z-score is a statistical measure to describe whether a mean was above or below the standard. Weight, adjusted for age and sex, was analyzed as weight-for-age z-score. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of higher weight.|From Baseline at Week 24|FAS: participants who carry the intended CFTR mutations and received at least 1 dose of study drug. The aim of weight based dosing is to achieve similar exposures in children of different weights, thus the planned analysis is presented for the single treatment arm irrespective of weight-based dosing regimen.|||z-score||95% Confidence Interval|Least Squares Mean
2544891|NCT02953314|Secondary|Part B: Absolute Change in Weight||From Baseline at Week 24|FAS: participants who carry the intended CFTR mutations and received at least 1 dose of study drug. The aim of weight based dosing is to achieve similar exposures in children of different weights, thus the planned analysis is presented for the single treatment arm irrespective of weight-based dosing regimen.|||kg||95% Confidence Interval|Least Squares Mean
2544892|NCT02953314|Secondary|Part B: Relative Change in ppFEV1|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|From Baseline through Week 24|FAS: participants who carry the intended CFTR mutations and received at least 1 dose of study drug. The aim of weight based dosing is to achieve similar exposures in children of different weights, thus the planned analysis is presented for the single treatment arm irrespective of weight-based dosing regimen.|||percent change||95% Confidence Interval|Least Squares Mean
2545048|NCT02951273|Secondary|Changes in Stroke Volume From Baseline Before Induction of Anaesthesia.|Stroke volume [ml] as evaluated continuously by pulse contour analysis of the arterial pressure curve (Modelflow).|Continuous measurements from before induction of anaesthesia and until 2 hours after start of surgery.||||ml||95% Confidence Interval|Mean
2544893|NCT02953314|Secondary|Part B: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|From Baseline through Week 24|FAS: participants who carry the intended CFTR mutations and received at least 1 dose of study drug. The aim of weight based dosing is to achieve similar exposures in children of different weights, thus the planned analysis is presented for the single treatment arm irrespective of weight-based dosing regimen.|||percentage points||95% Confidence Interval|Least Squares Mean
2544894|NCT02953314|Secondary|Part B: AUCtau of TEZ, TEZ Metabolites (M1-TEZ, M2-TEZ), IVA, and IVA Metabolites (M1-IVA, M6-IVA )||Week 16|"PK set. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified time points."|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2544895|NCT02953314|Secondary|Part B: Cmax of TEZ, TEZ Metabolites (M1-TEZ, M2-TEZ), IVA, and IVA Metabolites (M1-IVA, M6-IVA)||Week 16|PK set. Here “Overall Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2544896|NCT02953314|Secondary|Part A: Number of Participants With AEs and SAEs||Day 1 up to Day 28|Safety set: included all participants who received at least 1 dose of study drug. The planned analysis was designed to assess overall treatment arm, irrespective of weight-based dosing regimen. The aim of weight based dosing is to achieve similar exposures in children of different weights, thus analysis is presented for the single treatment arm.|||participants|||Number
2544897|NCT02953314|Secondary|Part A: AUCtau of TEZ Metabolites (M1-TEZ, M2-TEZ) and IVA Metabolites (M1-IVA, M6-IVA)||Day 1 and Day 14|"PK set. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified time points. Number Analyzed=0 signified no subjects were evaluated for the specified parameter at that time point."|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2544898|NCT02953314|Secondary|Part A: Cmax of TEZ Metabolites (M1-TEZ, M2-TEZ) and IVA Metabolites (M1-IVA, M6-IVA)||Day 1 and Day 14|"PK set. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified time points."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2544899|NCT02953314|Primary|Part B: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)||Day 1 up to Week 28|Safety set: included all participants who received at least 1 dose of study drug. The planned analysis was designed to assess overall treatment arm, irrespective of weight-based dosing regimen. The aim of weight based dosing is to achieve similar exposures in children of different weights, thus analysis is presented for the single treatment arm.|||participants|||Number
2544900|NCT02953314|Primary|Part A: Area Under the Concentration Versus Time Curve During Dosing Interval (AUCtau) of TEZ and IVA||Day 1 and Day 14|"PK set. Here “Number Analyzed” signifies those participants who were evaluable for this outcome measure at specified time points.Number Analyzed=0 signified no subjects were evaluated for the specified parameter at that time point."|||hour*nanogram per milliliter (hr*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2544901|NCT02953314|Primary|Part A: Maximum Observed Concentration (Cmax) of TEZ and IVA||Day 1 and Day 14|Pharmacokinetic (PK) set included participants who received at least 1 dose of study drug and for whom the primary PK data were considered to be sufficient and interpretable. Here “Number Analyzed” signifies those participants who were evaluable for this outcome measure at specified time points.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2544902|NCT02952898|Other Pre-specified|Adverse Events (AEs)|AEs will be assessed by the investigator and the incidence (severity and causality) of any local and systemic AEs will be reported.|Day 0 through Day 90|||||||
2544903|NCT02952898|Primary|Number of Subjects With Complete Clearance of AK Lesions|Complete Clearance was defined as 100% clearance of all Actinic Keratosis (AK) lesions (having a count of zero AKs) in the treatment area (face or bald scalp) at the Day 90 visit (30 Days Post Treatment).|Day 90 (30 days after completion of 60 days of treatment)|Analysis shown is based on the modified Intent-to-Treat (mITT) population, defined as all randomized subjects who met the following requirements, 1) met all inclusion/exclusion criteria; 2) applied at least one dose of test article; 3) and returned for at least one post-baseline evaluation clinic visit (Visits 3, 5, or 6).|||percentage of participants|||Number
2544904|NCT02952872|Secondary|Intention to Reduce Alcohol Use|Participants self-report intentions to reduce drinking on the Drinking Intentions Questionnaire. On this questionnaire, participants rate how likely they are to reduce their drinking over the next week, month, and year on a scale ranging from '0 = Not at all likely' to '5 = Extremely likely.' Higher scores mean greater intentions to reduce drinking. In order to obtain more stable estimates and reduce type I error, responses to the week, month and year questions were summed to create a total drinking intentions score which could range from 0 to 15. More specifically, scores on each individual scale item (i.e. intentions to reduce drinking over the week, month and year) could range from 0 to 5. When summed together, these items created the total score (reported here) which could range from 0 to 15.|1 month and 3 months after baseline||||score on a scale||Standard Deviation|Mean
2544905|NCT02952872|Secondary|Report of Alcohol Related Consequences|Participant self-report on the Brief Young Adult Alcohol Consequences Questionnaire|1 month and 3 months after baseline||||Alcohol Consequences||Standard Deviation|Mean
2544906|NCT02952872|Secondary|Number of Heavy Drinking Days Per Month|Number of days participant reports drinking 4/5 (male/female) alcoholic drinks in a 2-hour period during the past 30 days|1 month and 3 months after baseline||||Heavy drinking days/month||Standard Deviation|Mean
2544907|NCT02952872|Primary|Mean Drinks Per Day|Average of reports from past 30 days on the number of standard drinks consumed by participant over the past 30 days.|1 month and 3 months after baseline||||Drinks per day||Standard Deviation|Mean
2544920|NCT02952820|Secondary|Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Active Treatment Period)||Baseline, First 7 nights (approximately Week 1) in active treatment period|Overall participants analyzed based on number in “On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)”. Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.|||score on a scale||Standard Deviation|Mean
2544908|NCT02952820|Secondary|Persistence of Effect: Mean Change From Study Baseline and Period 2 Baseline (Month 6) in sSE at Months 3 and 6 Exposure Compared to Month 1|sSE was defined as percentage of sTST per subjective time spent in bed, calculated as the interval from the time the participant reports attempting to sleep until the time the participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. At 3 and 6 months of exposure, the change from Baseline was compared to the lower bound of the 95% CI for sSE at 1 month of exposure. Persistence of effect was defined as present if the mean change from Baseline at 6 months of exposure was above the lower bound of the 95% CI at 1 month of exposure for sSE.|Baseline, Month 1, 3, 6|On-treatment FAS was the group of participants who received at least 1 dose of lemborexant and had at least 1 post dose primary efficacy measurement. Overall Participants Analyzed here is based on the number in the “On-Treatment FAS”. Hence these numbers include the lemborexant data from the participants re-randomized from placebo in Period 1.|||percentage of sTST||95% Confidence Interval|Least Squares Mean
2544909|NCT02952820|Secondary|Persistence of Effect: Mean Change From Study Baseline and Period 2 Baseline (Month 6) in sSOL, sWASO, and sTST at Months 3 and 6 Exposure Compared to Month 1|sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. sWASO: sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. At 3 and 6 months of exposure, the change from Baseline was compared to either the lower bound of the 95% CI for sTST or the upper bound of the 95% CI (for sSOL and sWASO) at 1 month of exposure. Persistence of effect was defined as present if the mean change from Baseline at 6 months of exposure was above the lower bound of the 95% CI at 1 month of exposure for sTST and below the upper bound of the 95% CI at 1 month of exposure for sSOL and sWASO.|Baseline, Month 1, 3, 6|Overall participants analyzed based on number in “On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)”. Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.|||minutes||95% Confidence Interval|Least Squares Mean
2544910|NCT02952820|Secondary|Persistence of Effect: Mean Change From Period 2 Baseline (Month 6) in sSE at Months 9 and 12 Compared to Month 7|sSE: percentage of sTST per subjective time spent in bed, calculated as the interval from the time the participant reports attempting to sleep until the time the participant stopped trying to sleep for the night (operationalized as the time the subject got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. At each month beyond Month 7, the change from Baseline was compared to the lower bound of the 95% CI for sSE at Month 7. Persistence of effect was defined as present if the mean change from Baseline at Month 12 was above the lower bound of the 95% CI at Month 7 for sSE.|Baseline, Month 7, 9, 12|Overall participants analyzed based on number in “On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)”. Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.|||percentage of sTST||95% Confidence Interval|Least Squares Mean
2544911|NCT02952820|Secondary|Persistence of Effect: Mean Change From Period 2 Baseline (Month 6) in sSOL, sWASO, and sTST at Months 9 and 12 Compared to Month 7|sSOL is defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. sWASO: sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. At each month beyond Month 7, the change from Baseline was compared to either the lower bound of the 95% CI for sTST or the upper bound of the 95% CI (for sSOL and sWASO) at Month 7. Persistence of effect was defined as present if the mean change from Baseline at Month 12 was above the lower bound of the 95% CI at Month 7 for sTST and below the upper bound of the 95% CI at Month 7 for sSOL and sWASO.|Baseline, Month 7, 9, 12|Overall participants analyzed based on number in “On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)”. Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.|||minutes||95% Confidence Interval|Least Squares Mean
2544912|NCT02952820|Secondary|Persistence of Effect: Mean Change From Baseline in sSE at Months 3, 6, 9, and 12 Compared to Month 1|sSE was defined as percentage of sTST per subjective time spent in bed, calculated as the interval from the time the participant reports attempting to sleep until the time the participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO. At each month beyond Month 1, the change from Baseline was compared to the lower bound of the 95% CI at Month 1. Persistence of efficacy was defined as present if the mean change from Baseline at Month 6 was above the lower bound of the 95% CI at Month 1 for sSE.|Baseline, Months 1, 3, 6, 9, and 12|Overall participants analyzed based on number in “On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)”. Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.|||percentage of sTST||95% Confidence Interval|Least Squares Mean
2544921|NCT02952820|Secondary|Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6|"The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question:~How sleepy/alert do you feel this morning? Participants rated their sleepiness/alertness level on a scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome."|Baseline, (mean of 7 nights [approximately Week 1]) in placebo-controlled period, Month 1, 3, 6|The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point.|||score on a scale||Standard Deviation|Mean
2547284|NCT02909140|Secondary|Percentage of Patients With an Increase in the Blood Pressure or Heart Rate||intraoperative|Data not available because data was not collected||||||
2544913|NCT02952820|Secondary|Persistence of Effect: Mean Change From Baseline in sSOL, sWASO, and sTST at Months 3, 6, 9, and 12 Compared to Month 1|sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset. sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. At each month beyond Month 1, the change from Baseline was compared to either the lower bound of the 95% CI (for sTST) or the upper bound of the 95% CI (for sSOL and sWASO) at Month 1. Persistence of efficacy was defined as present if the mean change from Baseline at Month 6 was above the lower bound of the 95% CI at Month 1 for sTST and below the upper bound of the 95% CI at Month 1 for sSOL and sWASO.|Baseline, Month 1, 3, 6, 9, 12|Overall participants analyzed based on number in “On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)”. Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.|||minutes||95% Confidence Interval|Least Squares Mean
2544914|NCT02952820|Secondary|Rebound Insomnia: Percentage of Participants Whose sWASO is Higher Than at Screening for First 3 Nights of the Follow-up Period, or Whose Mean sWASO is Higher Than at Screening for the First 7 Nights or Last 7 Nights of the Follow-up Period|Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day.|First 3 nights, First and Last 7 nights of the follow up period (Week 52 to 54)|Overall participants analyzed based on number in “On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)”. Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.|||percentage of participants|||Number
2544915|NCT02952820|Secondary|Rebound Insomnia: Percentage of Participants Whose sSOL Was Longer Than at Screening for First 3 Nights of the Follow-up Period, or Whom Mean sSOL Was Longer Than at Screening for First 7 Nights or Last 7 Nights of the Follow-up Period|Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset.|First 3 nights, first and last 7 nights of the follow up period (Week 52 to 54)|Overall participants analyzed based on number in “On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)”. Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.|||percentage of participants|||Number
2544916|NCT02952820|Secondary|Rebound Insomnia: Mean sWASO on Each of the First 3 Nights, First 7 Nights, and Last 7 Nights of the Follow-up Period|Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day.|First 3 nights, first and last 7 nights of the follow up period (Week 52 to 54)|Overall participants analyzed based on number in “On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)”. Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.|||minutes||Standard Deviation|Mean
2544917|NCT02952820|Secondary|Rebound Insomnia: Mean sSOL on Each of the First 3 Nights, First 7 Nights, and Last 7 Nights of the Follow-up Period|Rebound Insomnia: Rebound insomnia was defined as insomnia that occurred following discontinuation of a sedative substance taken to relieve primary insomnia. sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset.|First 3 nights, first and Last 7 nights of the follow up period (Week 52 to 54)|Overall participants analyzed based on number in “On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)”. Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.|||minutes||Standard Deviation|Mean
2544918|NCT02952820|Secondary|Change From Baseline in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at Months 1, 3, 6, 9 and 12|"The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question:~How sleepy/alert do you feel this morning? Participants rated their sleepiness/alertness level on a scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome."|Baseline, Months 1, 3, 6, 9 and 12|Overall participants analyzed based on number in “On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)”. Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.|||score on a scale||Standard Deviation|Mean
2544919|NCT02952820|Secondary|Change From Screening in Mean Rating on the Morning Sleepiness Item of the Sleep Diary at the First and Second 7 Mornings of the Follow-up Period|"The Sleep Diary was used to assess subjective ratings of morning sleepiness with the following question:~How sleepy/alert do you feel this morning? Participants rated their sleepiness/alertness level on a scale from 1 to 9, with 1 being extremely poor (sleepy) and 9 being extremely good (alert). Higher score indicated better outcome."|Screening, First and second 7 mornings in follow-up period (Week 52 to 54)|Overall participants analyzed based on number in “On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)”. Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.|||score on a scale||Standard Deviation|Mean
2544932|NCT02952313|Secondary|Subject Satisfaction Questionnaire|Participants rate whether they are satisfied or not satisfied with the procedure and cosmetic appearance after the procedure. The percent of participants reporting satisfaction with the procedure is reported.|6 months|All participants with satisfaction questionnaires completed at the 6-month follow-up.|||Participants|||Count of Participants
2544922|NCT02952820|Secondary|Change From Baseline in Fatigue Severity Scale (FSS) Total Score at Months 1, 3 and 6|"The FSS is a self-reported scale on which participants were instructed to choose a number from 1 to 7 that indicated their degree of agreement with 9 statements about their fatigue where 1 indicates strongly disagree and 7, strongly agree. The FSS total score was the sum of all responses to the 9 questions. Higher total scores and average item scores indicated greater fatigue. Total score range is 9 to 63."|Baseline, Months 1, 3 and 6|The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point.|||score on a scale||Standard Deviation|Mean
2544923|NCT02952820|Secondary|Change From Baseline in Insomnia Severity Index (ISI) Daytime Functioning Score at Months 1, 3, and 6|The ISI is a 4-7 item, self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated were: 1. severity of sleep onset; 2. sleep maintenance; 3. early morning awakening problems; 4. sleep dissatisfaction; 5. interference of sleep difficulties with daytime functioning; 6. noticeability of the sleep problems by others; and 7. distress caused by the sleep difficulties. A 5-point Likert scale was used to rate each item (from 0=no problem to 4=very severe problem). Daytime functioning score (sum of items 4 to 7) were analyzed. Higher score indicated severe insomnia problem. The total score range for sum of items is 0-16.|Baseline, Months 1, 3, and 6|The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point.|||score on a scale||Standard Deviation|Mean
2544924|NCT02952820|Secondary|Percentage of Sleep Onset Responders and Sleep Maintenance Responders at Month 12|Sleep onset responder was defined as follows: sSOL at study Baseline was >=30 minutes and mean sSOL at 6 months was <=20 minutes. Sleep maintenance responder was defined as follows: sWASO at study Baseline was >=60 minutes and mean sWASO at 6 months was <=60 minutes and showed a reduction of > 10 minutes compared to study Baseline.|Month 12|Overall participants analyzed based on number in “On-Treatment FAS (Participants who received at least 1 dose of lemborexant and had at least 1 postdose primary efficacy measurement)”. Hence, these numbers include lemborexant data from participants re-randomized from placebo in Period 1. Number analyzed=participants analyzed at specified timepoint.|||percentage of participants|||Number
2544925|NCT02952820|Secondary|Percentage of Sleep Onset Responders and Sleep Maintenance Responders at Month 6|Sleep onset responder was defined as follows: sSOL at study Baseline was greater than or equal to (>=) 30 minutes and mean sSOL at 6 months was less than or equal to (<=) 20 minutes. Sleep maintenance responder was defined as follows: sWASO at study Baseline was >=60 minutes and mean sWASO at 6 months was <=60 minutes and showed a reduction of greater than (>)10 minutes compared to Study Baseline.|Month 6|The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to number of participants evaluable for specified category.|||percentage of responders|||Number
2544926|NCT02952820|Secondary|Change From Baseline in sTST at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6|sTST was defined as minutes of sleep from sleep onset to time stopped trying to sleep for the night.|Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6|The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point.|||minutes||Standard Deviation|Mean
2544927|NCT02952820|Secondary|Change From Baseline in Subjective Wake After Sleep Onset (sWASO) at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6|sWASO was defined as sum of estimated minutes of wake during the night after initial sleep onset until the time the participant stopped trying to sleep for the night, operationalized as the time the participant got out of bed for the day.|Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6|The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point.|||minutes||Standard Deviation|Mean
2544928|NCT02952820|Secondary|Change From Baseline in Subjective Sleep Efficiency (sSE) at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1, 3 and 6|sSE was defined as percentage of subjective total sleep time (sTST) divided by subjective time spent in bed, calculated as the interval from the time the participant reported attempting to sleep until the time participant stopped trying to sleep for the night (operationalized as the time the participant got out of bed for the day), and time spent asleep derived from subjective time spent in bed minus sWASO.|Baseline, (mean of 7 nights [approximately Week 1]), Months 1, 3 and 6|The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point.|||percentage of sTST||Standard Deviation|Mean
2544929|NCT02952820|Secondary|Change From Baseline in sSOL at the Beginning of Treatment (Mean of the 7 Nights After the First Dose in Placebo-Controlled Period), and at Months 1 and 3|sSOL was defined as estimated minutes from time attempted to sleep to sleep onset.|Baseline, (mean of 7 nights [approximately Week 1]), Months 1 and 3|The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point.|||minutes||Standard Deviation|Mean
2544930|NCT02952820|Primary|Change From Baseline in Subjective Sleep Onset Latency (sSOL) at Month 6|sSOL was defined as estimated minutes from the time that the participant attempted to sleep until sleep onset.|Baseline and Month 6|The FAS was the group of randomized participants who received at least one dose of randomized study drug and had at least one postdose primary efficacy measurement. Number analyzed refers to participants evaluable for this outcome measure at specified time point.|||minutes||Standard Deviation|Mean
2544931|NCT02952313|Secondary|Procedure and Device Related Adverse Events|Number of participants who experience procedure or device-related adverse events.|12, 18 and 24 months post procedure||2020-12-31|12/2020||||
2544933|NCT02952313|Secondary|Change in Nasal Airway Obstruction From Baseline Using the Visual Analog Scale (VAS).|Change from baseline in VAS score for ability to breathe through the nose. Participants provide scores on a scale of 0 (easy to breathe through the nose) to 100 (unable to breathe through the nose).|1, 3, 6, 12, 18 and 24 months post procedure||2020-12-31|12/2020||||
2544934|NCT02952313|Secondary|Percent of Treatment Responders|Responder is defined as a participant who has improvement of at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class or at least 20% NOSE score reduction. NOSE scores. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100).|1, 3 12, 18 and 24 months post procedure.||2020-12-31|12/2020||||
2544935|NCT02952313|Primary|Primary Safety Endpoint: Nasal Procedure and Latera™ Device-related Adverse Events|Number of participants with a device-related or procedure-related adverse event|6 months post procedure||||Participants|||Count of Participants
2544936|NCT02952313|Primary|The Primary Efficacy Endpoint is the Percent of Treatment Responders|Responder is defined as a participant who has improvement of at least 1 Nasal Obstruction Symptom Evaluation (NOSE) class or at least 20% NOSE score reduction. NOSE scores. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100).|6 months post procedure|All participants with 6-month NOSE scores|||Participants|||Count of Participants
2544937|NCT02952261|Secondary|Complication Rate|Pnuemothorax related to lung nodule localization|From the time of completing final CT scan, assessed up to 2 days.||||Participants|||Count of Participants
2544938|NCT02952261|Secondary|Radiation Dose|Radiation dosage was read on the monitor screen of CT scanner and converted to effective dosage.|From the time of completing final CT scan, assessed up to 1 hour.||||mGy*cm||Standard Deviation|Mean
2544939|NCT02952261|Secondary|Procedural Duration of the Nodule Localization|Procedural duration was derived from CT scan parameters, which was calculated as the time length between the initial and final scan.|From the time of completing final CT scan, assessed up to 1 hour.||||min||Standard Deviation|Mean
2544940|NCT02952261|Primary|Accuracy of Lung Nodule Localization|Localization accuracy was defined by the localizer deviation between the hookwire and the center of the target nodule. (The deviation was measured using CAD software after downloading the CT images from the Picture Archiving and Communication Systems.)|From the time of completing final CT scan, assessed up to 2 days.|Modified Intention-to-treat analysis (patients who did not receive lung nodule localization were excluded.(n=10))|||mm||Standard Deviation|Mean
2544941|NCT02951988|Primary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales|"On the C-SSRS, the 5 types of suicidal ideation are:~Type 1: Wish to be dead Type 2: Non-specific active suicidal thoughts Type 3: Active suicidal ideation with any methods (not plan) without intent to act Type 4: Active suicidal ideation with some intent to act, without specific plan Type 5: Active suicidal ideation with specific plan and intent"|104 Weeks|The Double-blind modified Intent-to-Treat Population consists of all patients in the Open-label Safety Population who were randomized to a treatment group during the DBTP of the study and received at least 1 dose of IP during the DBTP. 1 subject in the Biweekly Rapastinel group did not have any responses regarding the C-SSRS during the DBTP.|||Participants|||Count of Participants
2544942|NCT02951988|Secondary|Time to First Relapse During the Entire Double-Blind Treatment Period|The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.|104 Weeks|The Double-blind modified Intent-to-Treat Population consists of all patients in the Open-label Safety Population who were randomized to a treatment group during the DBTP of the study and received at least 1 dose of IP during the DBTP.|||Days||95% Confidence Interval|Median
2544943|NCT02951988|Primary|Time to First Relapse During the First 52 Weeks of the Double-Blind Treatment Period|The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse.|52 Weeks|The Double-blind modified Intent-to-Treat Population consists of all patients in the Open-label Safety Population who were randomized to a treatment group during the DBTP of the study and received at least 1 dose of IP during the DBTP.|||Days||95% Confidence Interval|Median
2544944|NCT02951884|Secondary|Supplemental Analgesia|Twenty-four hours after injury, the researchers will record the number of participants that required supplemental analgesia.|24 hours|The analysis population comprises both participants who consented to participate in the trial|||Participants|||Count of Participants
2544945|NCT02951884|Primary|Numerical Rating Scale (NRS) Pain Scores|Twenty-four hours after injury, patients will self report their numerical rating scale (NRS) score. The NRS score ranges from 0 to 10 with higher scores indicating greater pain.|24 hours|The analysis population comprises both participants who consented to participate in the trial|||units on a scale|||Number
2544946|NCT02951819|Secondary|Percentage of Participants With Treatment Emergent-Adverse Event|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between administration of study drug and approximately up to 15 months that were absent before treatment or that worsened relative to pre-treatment state.|Approximately 15 months|Safety Analysis Set defined as enrolled participants who received at least 1 dose (partial or complete) of study treatment (Dara-CyBorD).|||Percentage of participants|||Number
2544947|NCT02951819|Secondary|Overall Survival (OS)|Overall survival (OS) was measured from the date of first dose (start of induction) to the date of death due to any cause.|Approximately 15 months|Full analysis set is defined as enrolled participants who provided informed consent and met eligibility criteria.|||Months||95% Confidence Interval|Median
2544954|NCT02951819|Primary|Percentage of Participants Who Achieved Complete Response (CR) or Very Good Partial Response (VGPR)|Percentage of participants who achieved CR or VGPR (as per International Myeloma Working Group [IMWG] criteria) was reported. CR: negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5 percent (%) plasma cells (PC) in bone marrow. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to (>=) 90% reduction in serum M-protein plus urine M-protein level < 100 milligram per 24 hours (mg/24hours).|After 4 cycles of Induction (Approximately 4 months)|Response-evaluable set includes all enrolled participants who had measurable disease, received at least 1 dose of study treatment, and had at least 1 efficacy evaluation assessment.|||Percentage of Participants||95% Confidence Interval|Number
2544948|NCT02951819|Secondary|Time to Disease Progression (TTP)|TTP was defined as the time between the date of first dose (start of induction) and the date of first documented evidence of confirmed PD, as defined in the IMWG response criteria. PD per IMWG criteria: Increase of 25% from lowest response value in one of following: Serum and urine M-component (absolute increase >=0.5 g/deciliter (dL) and >=200 mg/24 hours respectively); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase>10 mg/dL); Only participants without measurable serum and urine M-protein levels, without measurable disease by FLC levels, bone marrow PC% (absolute % >=10%); Bone marrow PC%: absolute% >10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.|Approximately 15 months|Full Analysis Set defined as enrolled subjects who provided informed consent and met eligibility criteria.|||Months||95% Confidence Interval|Median
2544949|NCT02951819|Secondary|Progression Free Survival (PFS)|PFS: duration from date of first dose (start of induction) to date of first documented evidence of progressive disease (PD) based on computerized algorithm per IMWG criteria or death due to any cause, whichever occurred first. PD: 25% increase from lowest response value in one of following: Serum and urine M-component (absolute increase >=0.5 g/dL and >=200 mg/24 hours respectively);Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase>10 mg/dL);Only participants without measurable serum and urine M-protein levels, without measurable disease by FLC levels, bone marrow PC% (absolute % >=10%); Bone marrow PC%: absolute% >10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas, Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.|Approximately 15 months|Full analysis set is defined as enrolled participants who provided informed consent and met eligibility criteria.|||Months||95% Confidence Interval|Median
2544950|NCT02951819|Secondary|Duration of Response (DOR)|DOR was defined for participants with a confirmed response (PR or better) as the duration from the date of initial documentation of a response (PR or better) according to the IMWG criteria to the date of first documented evidence of progressive disease according to the IMWG criteria or death due to progressive disease. PR:>=50% reduction of serum M-protein and reduction in 24hours urinary M-protein by >=90% or to <200 mg/24hours. If serum and urine M-protein are unmeasurable, a >=50% decrease in difference involved and uninvolved FLC levels required in place of M-protein criteria. If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in PCs is required in place of M-protein, provided baseline bone marrow PCs % was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|Approximately 15 months|Population included responders (PR or better) in response-evaluable set.|||Months||95% Confidence Interval|Median
2544951|NCT02951819|Secondary|Time to Partial Response (PR) or Better|Time to PR or Better response was defined as duration from the date of first dose (start of induction) to the date of initial documentation of the response (PR or better) which was confirmed by a repeated measurement as required by the IMWG criteria. PR is defined as per IMWG criteria as >= 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >= 90% or to < 200 mg/24hours. If the serum and urine M-protein are unmeasurable, a>= 50% decrease in the difference between involved and uninvolved Free light chain (FLC) levels is required in the place of the M-protein criteria. If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cells percentage was >=30%. In addition to the above listed criteria, if present at baseline, a >= 50% reduction in the size of soft tissue plasmacytomas is also required.|Approximately 12 months|Response-evaluable set includes all enrolled participants who had measurable disease, received at least 1 dose of study treatment, and had at least 1 efficacy evaluation assessment.|||Months||95% Confidence Interval|Median
2544952|NCT02951819|Secondary|Time to Very Good Partial Response (VGPR) or Better|Time to VGPR or Better response was defined as duration from the date of first dose (start of induction) to the date of initial documentation of the response (VGPR or better) which was confirmed by a repeated measurement as required by the IMWG criteria. VGPR is defined by IMWG criteria as serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to (>=) 90 % reduction in serum M-protein plus urine M-protein level < 100 milligram/24 hours (mg/24 hours).|Approximately 12 months|Response-evaluable set includes all enrolled participants who had measurable disease, received at least 1 dose of study treatment, and had at least 1 efficacy evaluation assessment.|||Months||95% Confidence Interval|Median
2544953|NCT02951819|Secondary|Overall Response Rate (ORR)|ORR: percentage of participants achieved PR or better (PR,VGPR,CR,sCR) per IMWG. CR:negative immunofixation on serum, urine, disappearance of soft tissue plasmacytomas,<5% PCs in bone marrow(BM). sCR:CR plus normal FLC ratio,absence of clonal cells in BM by immunohistochemistry, immunofluorescence. VGPR:Serum, urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg/24hours. PR:>=50% reduction of serum M-protein and reduction in 24hours urinary M-protein by >=90% or to <200mg/24hours. If serum, urine M-protein unmeasurable, a>=50% decrease in difference involved and uninvolved FLC levels required in place of M-protein criteria. If serum, urine M-protein not measurable, serum free light assay is not measurable,>=50% reduction in PCs required in place of M-protein,provided baseline bone marrow PCs% >=30%, if present at baseline, a >=50% reduction in size of soft tissue plasmacytomas is also required.|After 4 Cycles of Induction (4 months), at End of Induction (4 to 8 months) and at the End of Maintenance (12 months)|Response-evaluable set includes all enrolled participants who had measurable disease, received at least 1 dose of study treatment, and had at least 1 efficacy evaluation assessment.|||Percentage of participants||95% Confidence Interval|Number
2544955|NCT02951780|Primary|Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of C-Peptide of LY3185643 and rGlucagon|Area under the concentration versus time curve from time zero to 3 hours [AUC (0-3)] was assessed for C-peptide of LY3185643 and rGlucagon.|-5, 0 (pre-dose), 5, 15, 30, 60 and 120 minutes post-dose|All randomized participants who received at least one dose of study drug (C-peptide of LY3185643 and rGlucagon) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PD data.|||picomole*hour per liter (pmol*h/L)||Standard Deviation|Mean
2544956|NCT02951780|Primary|Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of Blood Glucose of LY3185643 and rGlucagon|Area under the concentration versus time curve from time zero to 3 hours [AUC (0-3)] was assessed for LY3185643 and rGlucagon.|-5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose|All randomized participants who received at least one dose of study drug (LY3185643, C-peptide) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PD data.|||milligram*hour per deciliter (mg*hr/dL)||Standard Deviation|Mean
2544957|NCT02951780|Primary|Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of C-peptide of LY3185643 and rGlucagon|Cmax was assessed for C-peptide of LY3185643 and rGlucagon|-5, 0 (predose), 5, 15, 30, 60 and 120 minutes post-dose|All randomized participants who received at least one dose of study drug (C-peptide of LY3185643 and rGlucagon) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PD data.|||picomole per liter (pmol/L)||Standard Deviation|Mean
2544958|NCT02951780|Primary|Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of Blood Glucose of LY3185643 and rGlucagon|Cmax was assessed for LY3185643 and rGlucagon.|-5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose|All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PD data.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2544959|NCT02951780|Primary|Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3185643 and rGlucagon|Area under the concentration versus time curve from zero to infinity (AUC0-inf) was assessed for LY3185643 and rGlucagon.|0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose|All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PK data.|||picogram*hour per milliliter (pg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2544960|NCT02951780|Primary|Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3185643 and rGlucagon|Maximum observed plasma concentration (Cmax) was assessed for LY3185643 and rGlucagon.|0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose|All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PK data.|||picogram per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2544961|NCT02951767|Secondary|Percentage of Participants Positive for Anti-therapeutic Antibodies (ATA) to Atezolizumab||Day 1 of all cycles (Cycle length = 21 days) and at treatment discontinuation (data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 Safety Evaluable Population. Here, number of participants analyzed = participants for whom ATA samples were available.|||percentage of participants|||Number
2544962|NCT02951767|Secondary|Minimum Serum Concentration (Cmin) of Atezolizumab||Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (Cycle length = 21 days)|Cohort 1 PK evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. “n” = participants who were evaluable at specified timepoint.|||mcg/mL||Standard Deviation|Mean
2544963|NCT02951767|Secondary|Maximum Serum Concentration (Cmax) of Atezolizumab||Pre-dose (0 hours) and 30 minutes post-dose on Day 1 of Cycle 1 (Cycle length = 21 days)|Cohort 1 pharmacokinetic (PK) evaluable population was defined as participants who received any dose of atezolizumab treatment and had PK data at timepoints that were sufficient to determine PK parameters. Here, number of participants analyzed = participants who were evaluable for this outcome.|||microgram(s)/milliliter (mcg/mL)||Standard Deviation|Mean
2544964|NCT02951767|Secondary|Percentage of Participants Alive at 1-year||1-year|Cohort 1 ITT population.|||percentage of participants||95% Confidence Interval|Number
2544965|NCT02951767|Secondary|Overall Survival (OS)|OS was defined as the time from start of treatment to the time of death from any cause on study.|Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 ITT population.|||months||95% Confidence Interval|Median
2544966|NCT02951767|Secondary|Percentage of Participants Who Died|The percentage of participants who died from any cause was reported.|Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 ITT population.|||percentage of participants|||Number
2544967|NCT02951767|Secondary|Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 objective response-evaluable population.|||percentage of participants||95% Confidence Interval|Number
2544968|NCT02951767|Secondary|PFS as Assessed by the Investigator According to RECIST v1.1|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 ITT population.|||months||95% Confidence Interval|Median
2545049|NCT02951273|Secondary|Changes in Cardiac Output From Baseline Before Induction of Anaesthesia.|Cardiac output [l/min] as evaluated continuously by pulse contour analysis of the arterial pressure curve (Modelflow).|Continuous measurements from before induction of anaesthesia and until 2 hours after start of surgery.||||l/min||95% Confidence Interval|Mean
2544969|NCT02951767|Secondary|Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 ITT population.|||percentage of participants|||Number
2544970|NCT02951767|Secondary|Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 ITT population.|||months||95% Confidence Interval|Median
2544971|NCT02951767|Secondary|Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1|Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 ITT population.|||percentage of participants|||Number
2544972|NCT02951767|Secondary|DOR as Assessed by the Investigator According to RECIST v1.1|DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||months||Full Range|Median
2544973|NCT02951767|Secondary|Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1|DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||months||Full Range|Median
2544974|NCT02951767|Primary|Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to RECIST v1.1|Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% confidence interval (CI) was calculated using the Clopper-Pearson method.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)|Cohort 1 objective response-evaluable population included intent-to-treat (ITT) participants who had measurable disease per RECIST v1.1 at baseline. Cohort 1 ITT population included all participants from Cohort 1 who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
2544975|NCT02951702|Secondary|Clostridium Difficile Infection Severity|Severity as defined by the IDSA/SHEA guidelines (mild to moderate, defined as white-cell count less than 15,000 cells/µL or increase in serum creatinine (SCr) by <1.5 times the baseline; severe, defined as white-cell count greater than 15,000 cells/µL or increase in SCr by >1.5 times the baseline; and fulminant, defined as the criteria above for severe with shock, hypotension, ileus, or megacolon)|Within 4 weeks from completion of antibiotic treatment||||participants|||Number
2544976|NCT02951702|Secondary|Time to Clostridium Difficile Infection Occurence|This is the time from the start of antibiotics to the diagnosis of clostridium difficile.|Within 4 weeks from completion of antibiotic treatment||||days||Full Range|Mean
2544977|NCT02951702|Primary|Clostridium Difficile Infection Occurrence|The incidence of clostridium difficile infection as detected for GDH/toxin positive or PCR if the GDH/toxin is equivocal.|Within 4 weeks from the completion of antibiotic treatment||||Participants|||Count of Participants
2546662|NCT02918357|Secondary|Percentage of Participants With Change in Clinical Management|Clinical management changes were assessed using surveys of Intended Management to determine the percent change in clinical management after 68Ga-PSMA-11 PET.|Up to 1 year||||Percentage of participants|||Number
2544978|NCT02951533|Secondary|Part III: Percentage of Participants With Adverse Drug Reactions (ADRs) as a Measure of Safety and Tolerability|ADRs were defined as those adverse events with causality 'very likely', 'probable', or 'possible' that occurred during the follow-up extension period from Week 64 to Week 100 or those present before Week 64 but ongoing at Week 64.|Week 64 to Week 100|Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study) and entered Study Part III.|||Percentage of Participants|||Number
2544979|NCT02951533|Secondary|Part IIb: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (Week 32 to Week 64) as a Measure of Safety and Tolerability|An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs were defined as those AEs that occurred during the active treatment period from Week 32 to Week 56 or the safety follow-up period from Week 56 through Week 64 or those AEs that were present before Week 32 but worsened in severity after Week 32.|Week 32 to Week 64|Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Here, n (number of participants analyzed) signifies number of participants analyzed for this OM for specified category.|||Percentage of Participants|||Number
2544980|NCT02951533|Secondary|Part I/IIa: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) (up to Week 32) as a Measure of Safety and Tolerability|An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Treatment-emergent AEs (TEAEs) were defined as AEs that occurred during active treatment period through Week 32 after the start of initial study drug administration or AEs that were present at Baseline but worsened in severity after the start of initial study drug administration. Safety reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis.|Up to Week 32|Safety analysis set included all participants randomized to 1 of 2 treatment groups (GUS or FAE) at Week 0 and received at least 1 dose of study drug as per actual treatment received during study irrespective of treatment assigned at randomization. Here N (number of subjects analyzed) signifies number of participants evaluable for this OM.|||Percentage of Participants|||Number
2544981|NCT02951533|Secondary|Part III: Change From Baseline (Week 56) in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Week 100|SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0 = worst HRQL, 100=best HRQL. Higher scores indicate better health status.|Baseline (Week 56) and Week 100|Part III analysis set included all participants treated with GUS during Part IIb (Weeks 32 to 64, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using LOCF method.|||Units on a scale||Standard Deviation|Mean
2544982|NCT02951533|Secondary|Part III: Percentage of Participants Who Achieved an Scalp Specific Investigator´s Global Assessment (Ss-IGA) Score of 0 or 1 at Week 100 in Participants With Scalp Psoriasis and an Ss-IGA Score >=2 (at Least Mild Disease) at Baseline (Week 0)|The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).|Week 100|Population included Part III analysis set. Missing data imputed using NRI (participants with missing data at Week 64,76,88 and 100 were considered non-responders). Here N (number of participants analyzed) signifies number of participants with Scalp Psoriasis and an ss-IGA Score >=2 (at least mild disease) at Baseline (Week 0).|||Percentage of participants|||Number
2544983|NCT02951533|Secondary|Part III: Percentage of Participants Who Achieved Ss-IGA Score of Absence of Disease (0) at Week 100 in Participants With Scalp Psoriasis and Ss-IGA Score>=2 (at Least Mild Disease) at Baseline (Week 0)|The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).|Week 100|Population included Part III analysis set. Missing data imputed using NRI (participants with missing data at Week 64, 76, 88 and 100 were considered non-responders). Here N (number of participants analyzed) signifies number of participants with Scalp psoriasis and ss-IGA score >=2 at Baseline (Week 0).|||Percentage of participants|||Number
2544984|NCT02951533|Secondary|Part III: Percentage of Participants With a DLQI Score of 0 or 1 at Week 56 Who Maintained Response at Week 100|The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.|Week 100|Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data imputed using NRI (participants with missing data at Week 64,76,88 and 100 were considered non-responders).|||Percentage of participants|||Number
2545050|NCT02951273|Secondary|Changes in Mean Arterial Pressure From Baseline Before Induction of Anaesthesia.|Mean arterial pressure [mmHg] as recorded continuously by a transducer connected to an arterial line.|Continuous measurements from before induction of anaesthesia and until 2 hours after start of surgery.||||mmHg||95% Confidence Interval|Mean
2544985|NCT02951533|Secondary|Part III: Change From Baseline in DLQI Score at Week 100|The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.|Baseline (Week 56) and Week 100|Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using LOCF imputation method.|||Units on a scale||Standard Deviation|Mean
2544986|NCT02951533|Secondary|Part III: Percentage of Participants With a DLQI Score of 0 or 1 at Week 100|The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.|Week 100|Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using LOCF imputation method.|||Percentage of participants|||Number
2544987|NCT02951533|Secondary|Part III: Change From Baseline (Week 56) in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 100|BSA as physical measure to define disease severity is to determine how much of the Body Surface Area (BSA) is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.|Baseline (Week 56) and Week 100|Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using LOCF imputation method.|||Change in BSA (% points)||Standard Deviation|Mean
2544988|NCT02951533|Secondary|Part III: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 or 1 at Week 100|The Investigator's Global Assessment (IGA) documents the investigator's assessment of the participant's psoriasis at a given time. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 100|Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using NRI (participants with missing data at Week 64, 76,88 and 100 were considered non-responders).|||Percentage of participants|||Number
2544989|NCT02951533|Secondary|Part III: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of 0 at Week 100|The Investigator's Global Assessment (IGA) documents the investigator's assessment of the participant's psoriasis at a given time. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 100|Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using NRI (participants with missing data at Week 64, 76,88 and 100 were considered non-responders).|||Percentage of participants|||Number
2544990|NCT02951533|Secondary|Part III: Change From Baseline (Week 56) in Signs and Symptoms Aggregate Scores of the Psoriasis Symptom and Sign Diary (PSSD) Total Score at Week 100|The PSSD (7-day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items greater than or equal to (>=) 50 percentage of 5 items on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score=average value*10, where, 0= least severe and 100=most severe and higher score indicates more severe disease.|Baseline (Week 56) and Week 100|Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using last observed carried forward (LOCF) imputation method.|||Units on a scale||Standard Deviation|Mean
2544991|NCT02951533|Secondary|Part III: Percentage of Participants Who Achieved an Absolute PASI Score <=1, <=2, <=3, <=5 at Week 100|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.|Week 100|Study Part III analysis set included all participants who were treated with GUS during Part IIb (Weeks 32 to 64 of Study, and who were withdrawn from study treatment) and entered Part III. Missing data was imputed using NRI (participants with missing data at Week 64,76,88 and 100 were non-responders).|||Percentage of Participants|||Number
2544992|NCT02951533|Secondary|Part III: Percentage of Participants Who Achieved PASI 100 Response at Week 100|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.|Week 100|Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using NRI (participants with missing data at Week 64,76,88 and 100 were considered non-responders).|||Percentage of Participants|||Number
2544993|NCT02951533|Secondary|Part III: Percentage of Participants With PASI 90 Response at Week 56 Who Maintained PASI 90 Response at Week 100 After Drug Withdrawal|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.|Week 100|Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Missing data was imputed using NRI (participants with missing data at Week 64,76,88 and 100 were considered non-responders).|||Percentage of Participants|||Number
2544994|NCT02951533|Secondary|Part III: Time to PASI >3 From Week 52 After Guselkumab Withdrawal at Week 100|The time to PASI>3 from Week 52 after guselkumab withdrawal at Week 100 was calculated as time from Week 52 to PASI response that is PASI >3. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.|Week 100|Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Results were reported for observed cases.|||Days||95% Confidence Interval|Median
2544995|NCT02951533|Secondary|Part III: Time to Loss of Response (PASI >5) From Week 52 After Guselkumab Withdrawal at Week 100|The time to loss of response from Week 52 after guselkumab withdrawal at Week 100 was calculated as time from Week 52 to first onset of loss of response (PASI >5). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.|Week 100|Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Results were reported for observed cases.|||Days||95% Confidence Interval|Median
2544996|NCT02951533|Secondary|Part III: Time to PASI >3 From Week 56 After Guselkumab Withdrawal at Week 100|The time to PASI>3 from Week 56 after guselkumab withdrawal at Week 100 was calculated as time from Week 56 to PASI response that is PASI >3. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.|Week 100|Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Results were reported for observed cases.|||Days||95% Confidence Interval|Median
2545013|NCT02951533|Secondary|Part I: Change From Baseline in Percent Body Surface Area (%BSA) Psoriatic Involvement at Week 24|BSA as physical measure to define disease severity is to determine how much of the Body Surface Area (BSA) is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.|Baseline and Week 24|EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using LOCF imputation method. Here “N” (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Change in BSA (% points)||Standard Deviation|Mean
2547285|NCT02909140|Secondary|Percentage of Patients With an Increase in the Blood Pressure or Heart Rate||Baseline|Data not available because data was not collected||||||
2544997|NCT02951533|Secondary|Part III: Time to Loss of Response (PASI >5) From Week 56 After Guselkumab Withdrawal at Week 100|The time to loss of response from Week 56 after guselkumab withdrawal at Week 100 was calculated as time from Week 56 to first onset of loss of response (PASI >5). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease.|Week 100|Study Part III analysis set included all participants who were treated with guselkumab during Study Part IIb (Weeks 32 to 64 of the Study, and who were withdrawn from study treatment) and entered Study Part III. Results were reported for observed cases.|||Days||95% Confidence Interval|Median
2544998|NCT02951533|Secondary|Part III: Percentage of Participants With a PASI 90 Response at Week 56 Who Maintained Response (That is Who Had PASI Score <=5) at Week 100 After Drug Withdrawal|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.|Week 100|Study Part III analysis set included all participants who were treated with GUS during Part IIb (Weeks 32 to 64 of Study, and who were withdrawn from study treatment) and entered Part III. Missing data was imputed using NRI (participants with missing data at Week 64,76,88 and 100 were non-responders).|||Percentage of Participants|||Number
2544999|NCT02951533|Secondary|Part I/IIa: Percentage of Participants With a DLQI Score of 0 or 1 at Week 32|DLQI is 10-item questionnaire that measures impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. DLQI produces total numeric score ranging from 0 (not at all) to 30 (very much): 0-1=no effect at all on participant's life; 2-6 =small effect on participant's life; 7-12 = moderate effect on participant's life; 13-18 =very large effect on participant's life; 19-30 =extremely large effect on participant's life. Higher score indicates low quality of life due to more severe disease. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.|Week 32|EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).|||Percentage of Participants|||Number
2545000|NCT02951533|Secondary|Part I/IIa: Percentage of Participants Who Achieved PASI 100 Response at Week 32|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.|Week 32|EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).|||Percentage of Participants|||Number
2545001|NCT02951533|Secondary|Part I/IIa: Percentage of Participants Who Achieved PASI 90 Response at Week 32|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this OM.|Week 32|EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).|||Percentage of Participants|||Number
2545014|NCT02951533|Secondary|Part I: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score 0 at Week 24|The Investigator's Global Assessment (IGA) documents the investigator's assessment of the participant's psoriasis at a given time. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|At Week 24|EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).|||Percentage of Participants|||Number
2545002|NCT02951533|Secondary|Part I/IIa: Percentage of Participants Who Achieved PASI 75 Response at Week 32|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score. Data reported collectively for Part I and Part IIa (that is from Week 0 to Week 32) per planned analysis for this outcome measure (OM).|Week 32|EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).|||Percentage of Participants|||Number
2545003|NCT02951533|Secondary|Part IIb: Percentage of Participants With a DLQI Score of 0 or 1 at Week 56|The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.|Week 56|Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40,48 and 56 were considered non-responders).|||Percentage of Participants|||Number
2545004|NCT02951533|Secondary|Part IIb: Percentage of Participants With a PASI 100 Response at Week 56|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.|Week 56|Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40,48 and 56 were considered non-responders).|||Percentage of Participants|||Number
2545005|NCT02951533|Secondary|Part IIb: Percentage of Participants With a PASI 90 Response at Week 56|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.|Week 56|Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40,48 and 56 were considered non-responders).|||Percentage of Participants|||Number
2545006|NCT02951533|Secondary|Part IIb: Percentage of Participants With a PASI 75 Response at Week 56|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.|Week 56|Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40, 48, and 56 were considered non-responders).|||Percentage of Participants|||Number
2545031|NCT02951312|Secondary|AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr|0 to 12 hours post dose|All subjects who received at least one dose of study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis. A subject received more than one treatment type throughout the study.|||pg*h/mL||Standard Deviation|Mean
2545033|NCT02951312|Secondary|Tmax Time to Maximum Observed Plasma Concentration|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr|0 to 12 hours post dose|All subjects who received at least one dose of study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis. A subject received more than one treatment type throughout the study.|||hours||Standard Deviation|Mean
2545007|NCT02951533|Secondary|Part IIb: Percentage of Participants With DLQI Score of 0 or 1 at Week 32 Who Maintained Response at Week 56|The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.|Week 56|Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40,48 and 56 were considered non-responders).|||Percentage of Participants|||Number
2545008|NCT02951533|Secondary|Part IIb: Percentage of Participants With a PASI 90 Response at Week 32 Who Maintained Response at Week 56|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.|Week 56|Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40,48 and 56 were considered non-responders).|||Percentage of Participants|||Number
2545009|NCT02951533|Secondary|Part IIb: Percentage of Participants With a PASI 75 Response at Week 32 Who Maintained Response at Week 56|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.|Week 56|Study Part IIb analysis set included all participants who entered Study Part IIb and were treated with one of the two treatments (GUS or FAE) at least once during the treatment period from Week 32 to Week 56. Missing data was imputed using NRI (participants with missing data at Week 40, 48, and 56 were considered non-responders).|||Percentage of Participants|||Number
2545010|NCT02951533|Secondary|Part I: Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36 V2) Physical Component Summary (PCS) and Mental Component Summary (MCS) at Week 24|SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. Higher scores indicate better health status.|Baseline and Week 24|EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they received. Missing data was imputed using LOCF. Here “N” (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2545011|NCT02951533|Secondary|Part I: Percentage of Participants Who Achieved an Scalp Specific Investigator´s Global Assessment (Ss-IGA) Score of Absence of Disease (0) at Week 24|The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis (SP). The lesions are assessed in terms of the clinical signs of redness, thickness, and scaliness which are scored as: absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), and severe disease (4).|At Week 24|EAS: participants randomized to one of two treatments (GUS or FAE) at Week 0 regardless of treatment received and SP, ss-IGA Score>=2 at Baseline. Missing data was imputed using NRI (participants with missing data at Week 4,16, 24 were non-responders).|||Percentage of Participants|||Number
2545012|NCT02951533|Secondary|Part I: Change From Baseline in DLQI Score at Week 24|The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.|Baseline and Week 24|EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they received. Missing data was imputed using LOCF imputation method. Here N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2545015|NCT02951533|Secondary|Part I: Percentage of Participants Who Achieved an Absolute PASI Score Less Than or Equal to (=<) 1 at Week 24|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. Percentage of Participants who Achieved an absolute PASI score less than or equal to (=<) 1 were assessed.|At Week 24|EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).|||Percentage of Participants|||Number
2545016|NCT02951533|Secondary|Part I: Change From Baseline in the Individual Scale Scores for Itch, Pain, and Scaling of PSSD Components at Week 24|The PSSD (7 day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.|Baseline and Week 24|EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they received. Missing data was imputed using LOCF imputation method. Here N (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2545017|NCT02951533|Secondary|Part I: Change From Baseline in the Signs and Symptoms Aggregate Scores of the Psoriasis Symptoms and Signs Diary (PSSD) Score at Week 24|The PSSD (7-day version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items greater than or equal to (>=) 50 percentage of 5 items on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score=average value*10, where, 0= least severe and 100=most severe and higher score indicates more severe disease.|Baseline and Week 24|EAS included all participants who were randomized to one of two treatment groups (GUS or FAE) at Week 0 regardless of treatment they received. Missing data was imputed using last observed carried forward (LOCF) imputation method. Here N (number of participants analyzed) signifies number of participants evaluable for this outcome measure (OM).|||Units on a scale||Standard Deviation|Mean
2545018|NCT02951533|Secondary|Part I: Percentage of Participants Who Achieved PASI 100 Response at Week 24|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 100 response represents participants who achieved a 100% improvement from baseline in the PASI score.|At Week 24|EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).|||Percentage of Participants|||Number
2545019|NCT02951533|Secondary|Part I: Percentage of Participants Who Achieved a Dermatology Life Quality Index (DLQI) Score of Less Than or Equal to (=<) 1 at Week 24|The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life, can be used to assess 6 different aspects that may affect quality of life 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI produces a total numeric score that can range from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. A higher score indicates a low quality of life due to more severe disease.|At Week 24|EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).|||Percentage of Participants|||Number
2545032|NCT02951312|Secondary|AUC0-t Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr|0 to 12 hourr post dose|All subjects who received at least one dose of study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis.A subject received more than one treatment type throughout the study.|||pg*h/mL||Standard Deviation|Mean
2545047|NCT02951312|Primary|Number of Subjects Who Died||0-47 days|all subjects who received at least one dose of study medication were included in the safety analysis.. A subject received more than one treatment type throughout the study.|||Participants|||Count of Participants
2545020|NCT02951533|Secondary|Part I: Percentage of Participants Who Achieved PASI 75 Response at Week 24|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 % improvement from baseline in the PASI score.|At Week 24|EAS included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using NRI (participants with missing data at Week 4,16 and 24 were considered non-responders).|||Percentage of Participants|||Number
2545021|NCT02951533|Primary|Part I: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 24|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent [%] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produces a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 % improvement from baseline in the PASI score.|At Week 24|Efficacy analysis set (EAS) included all participants who were randomized to one of the two treatment groups (GUS or FAE) at Week 0 regardless of the treatment they actually received. Missing data was imputed using non-responder imputation (NRI) (participants with missing data at Week 4,16 and 24 were considered non-responders).|||Percentage of Participants|||Number
2545022|NCT02951351|Secondary|Expectation the Injection Will Contribute to Curing/Improving Eye Condition|Patients were asked to rate their expectation on the extent to which the intravitreal injections would contribute to curing or improving their eye condition. The question was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a negative response (not at all) and 10 was a positive response (to a large extent). A low score indicated the subject did not expect the injection would contribute to curing or improving the eye condition while a high score indicated the subject did expect the injection will help to cure or improve the eye condition.|post-injection||||score on a scale||Full Range|Median
2545023|NCT02951351|Secondary|Expectation Intravitreal Injection Will Have Negative Consequences on Subject Health|Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. A lower score indicated subjects did not expect the injection would negatively affect their overall health. Higher scores indicated subjects expected the injection would negatively affect their overall health.|post-injection||||score on a scale||Full Range|Median
2545024|NCT02951351|Secondary|Comfort With Intravitreal Injection Standard Procedure|Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the more comfortable the subject was with the procedure, the higher the score, the less comfortable the subject was with the procedure.|post-injection||||score on a scale||Full Range|Median
2545025|NCT02951351|Secondary|Impression of Pre-injection Preparations|Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey consisted of 6 questions and was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the more positive impression of the preparation process, the higher the score, the less positive impression of the preparation process..|post-injection||||score on a scale||Full Range|Median
2545026|NCT02951351|Secondary|Overall Impression of Visit for Intravitreal Injection|Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the more positive impression of the visit, the higher the score, the less positive impression of the visit.|post-injection||||score on a scale||Full Range|Median
2545027|NCT02951351|Secondary|Residual Pain From Intravitreal Injection|Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the lesser the residual pain, the higher the score, the higher the residual pain.|post-injection||||score on a scale||Full Range|Median
2545028|NCT02951351|Primary|Pain at the Time of Injection|Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the lesser the perceived pain, the higher the score, the higher the perceived pain.|post-injection||||score on a scale||Full Range|Median
2545029|NCT02951351|Primary|Number of Study Participants With Positive Conjunctival Culture|Conjunctival samples were collected after participants received either an additional drop of proparacaine or povidone iodine. Bacterial cultures were performed from conjunctival samples by the Mayo Clinic Microbiology laboratory. Bacterial species identification was performed on any and all bacteria that grew.|pre-injection||||Participants|||Count of Participants
2545030|NCT02951312|Secondary|t1/2 Plasma Half-life|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr.|0 to 12 hours post-dose|"Subjects who received at least one dose of study medication and have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis.Subject received more than one treatment type throughout the study~samples taken to obtain a plasma concentration by time profile were included in the PK analysis."|||hour||Standard Deviation|Mean
2545034|NCT02951312|Secondary|Cmax Maximum Observed Plasma Concentration|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr|0 to 12 hours post dose|"All subjects who received at least one dose of study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK . A subject received more than one treatment type throughout the study.~analysis."|||pg/mL||Standard Deviation|Mean
2545035|NCT02951312|Secondary|FEV1 AUC0-24 Area Under the FEV1 Over Time Curve (Change From Baseline)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.|0 to 24hr post dose|All subjects who received at least one dose of study medication and have at least one post baselineefficacy measurement were included in the efficacy population. A subject received more than one treatment type throughout the study.|||liters||Standard Deviation|Mean
2545036|NCT02951312|Secondary|Peak FEV1 (Change From Baseline )|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.|0 to 4hr|All subjects who received at least one dose of study medication and have at least one post baseline efficacy measurement were included in the efficacy population.. A subject received more than one treatment type throughout the study.|||liters||Standard Deviation|Mean
2545037|NCT02951312|Secondary|Peak FEV1 (Percent Change)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.|0 to 4hr|all subjects who received at least one dose of the study medication and have at least one post baseline efficacy measurement were included in the efficacy population. . A subject received more than one treatment type throughout the study.|||percent change||Standard Deviation|Mean
2545038|NCT02951312|Secondary|Trough FEV1 (Change From Baseline)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the spirometry value collected at 24 hours post dose within each Treatment Period.|24hr post dose|All subjects who received at least one dose of study medication and have at least one post baseline efficacy measurement were included in the efficacy population. A subject received more than one treatment type throughout the study.|||liters||Standard Deviation|Mean
2545039|NCT02951312|Primary|Number of Subjects With Treatment Emergent AEs|AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition.|0-47 days|all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study|||Participants|||Count of Participants
2545040|NCT02951312|Primary|Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study|Clinical safety lab parameters were collected at screening and at the post study follow-up assessment. The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study.|post study follow-up assessment (Day 47)|all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study.|||Participants|||Count of Participants
2545041|NCT02951312|Primary|Number of Subjects With Clinically Significant ECG Parameters Reported During the Study|ECGs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study follow-up assessment.|30hr post dose|all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study|||Participants|||Count of Participants
2545042|NCT02951312|Primary|Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study|Clinical safety lab parameters were collected at screening and at the post study follow-up assessment. The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study.|day 47 (post studyfollow-up assessment)|all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study.|||Participants|||Count of Participants
2545043|NCT02951312|Primary|Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study|Vital signs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study assessment. The clinical significance of each out of normal range vital sign parameter was determined by the investigator during the study.|30 hrs post dose|all subjects who received at least one dose of study medication were included in the safety analysis. . A subject received more than one treatment type throughout the study.|||Participants|||Count of Participants
2545044|NCT02951312|Primary|Percentage of Subjects With Treatment Emergent AEs|AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.|0-47 days|all subjects who received at least one dose of study medication were included in the safety analysis. . A subject received more than one treatment type throughout the study.|||percentage of participants|||Number
2545045|NCT02951312|Primary|Number of Subjects Who Discontinued Due to AE|AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.|0-47 days|all subjects who received at least one dose of study medication were included in the safety analysis. . A subject received more than one treatment type throughout the study.|||Participants|||Count of Participants
2545046|NCT02951312|Primary|Number of Subjects With Treatment Emergent SAEs|AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition.|0-47 days|all subjects who received at least one dose of study medication were included in the safety analysis.. A subject received more than one treatment type throughout the study.|||Participants|||Count of Participants
2545051|NCT02951273|Secondary|Changes in Heart Rate From Baseline Before Induction of Anaesthesia.|Heart rate [bpm] as recorded continuously by a transducer connected to an arterial line.|Continuous measurements from before induction of anaesthesia and until 2 hours after start of surgery.||||beats/min||95% Confidence Interval|Mean
2545052|NCT02951273|Secondary|Changes in the CO2 Reactivity of the Internal Carotid Artery From Before to After Induction of Anaesthesia.|"Unilateral internal carotid artery blood flow [ml/min] assessed by duplex ultrasound and arterial CO2 tension (PaCO2) [kPa] was evaluated by gas analysis. Changes in PaCO2 are guided by evaluation of end-tidal CO2 tension.~The CO2 reactivity to hypocapnia when awake and during anaesthesia is calculated as the percentage change in internal carotid artery blood flow per kPa change in PaCO2. The CO2 reactivity when awake and when anaesthetized is compared."|Four measurements; before induction of anaesthesia during normoventilation and during hyperventilation to reduce PaCO2 by 1.5 kPa and during anaesthesia at a PaCO2 at the value before induction of anaesthesia and 1.5 kPa below that value.|Comparison of reactivity to hypocapnia when awake and during anaesthesia was evaluated by a linear mixed model with the relative change in ICA flow as outcome and fixed effects were the change in PaCO2 and an interaction factor for the difference between awake and anaesthesia. The reported result is the interaction factor.|||%/kPa||95% Confidence Interval|Mean
2545053|NCT02951273|Secondary|Changes in Internal Carotid Artery Blood Flow by Development of Mesenteric Traction Syndrome (MTS).|Unilateral internal carotid artery blood flow [ml/min] assessed by duplex ultrasound as compared between those patients who develop a MTS (defined as flushing within 60 min after the start of surgery) and those who do not. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.|Six measurements during anaesthesia; 5 min before and after incision and 0, 20, 40, and 70 min after flushing and 20, 40, 60, and 90 min after the start of surgery in those patients who do not develop mesenteric traction syndrome.||||ml/min||95% Confidence Interval|Mean
2545054|NCT02951273|Secondary|Changes in Forehead Skin Oxygenation by Development of Mesenteric Traction Syndrome (MTS).|Forehead skin oxygenation [%] assessed by laser Doppler flowmetry as compared between those patients who develop a MTS (defined as flushing within 60 min after the start of surgery) and those who do not. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.|Six measurements during anaesthesia; 5 min before and after incision and 0, 20, 40, and 70 min after flushing and 20, 40, 60, and 90 min after the start of surgery in those patients who do not develop mesenteric traction syndrome.||||oxygenation [%]||95% Confidence Interval|Mean
2545055|NCT02951273|Secondary|Changes in Forehead Skin Blood Flow by Development of Mesenteric Traction Syndrome (MTS).|Forehead skin blood flow [PU] assessed by laser Doppler flowmetry as compared between those patients who develop mesenteric traction syndrome (defined as flushing within 60 min after the start of surgery) and those who do not. Laser Doppler flowmetry applies a laser placed on the forehead that penetrates the skin and is scattered with a Doppler shift by the red blood cells and return to a detector that evaluates the amount of backscattered light and Doppler shift. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.|Six measurements during anaesthesia; 5 min before and after incision and 0, 20, 40, and 70 min after flushing and 20, 40, 60, and 90 min after the start of surgery in those patients who do not develop mesenteric traction syndrome.||||PU||95% Confidence Interval|Mean
2545056|NCT02951273|Secondary|Changes in Frontal Lobe Oxygenation by Development of Mesenteric Traction Syndrome (MTS).|Near-infrared spectroscopy determined frontal lobe oxygenation [%] as compared between those patients who develop a MTS (defined as flushing within 60 min after the start of surgery) and those who do not. An effect of a MTS was evaluated by a repeated measure mixed model with the fixed effects time point, group according to development of MTS, and interaction between time and group. The reported result is the interaction factor for the time point 0 min after flushing and 20 min after the start of surgery in patients who did not develop MTS.|Six measurements during anaesthesia; 5 min before and after incision and 0, 20, 40, and 70 min after flushing and 20, 40, 60, and 90 min after the start of surgery in those patients who do not develop mesenteric traction syndrome.||||oxygenation [%]||95% Confidence Interval|Mean
2545057|NCT02951273|Secondary|Association by Multiple Regression Between Changes in Internal Carotid Artery Blood Flow, Mean Arterial Pressure and Cardiac Output by Treatment of Anaesthesia-induced Hypotension.|"Association by multiple regression between changes in unilateral internal carotid artery blood flow [ml/min] as outcome variable and changes in mean arterial pressure [mmHg] and cardiac output [l/min] as covariates.~Internal carotid artery blood flow [ml/min] was assessed by duplex ultrasound. Mean arterial pressure [mmHg] was recorded by a transducer connected to an arterial line. Cardiac output [l/min] was evaluated by pulse contour analysis (Modelflow) that estimates cardiac output by analysis of the arterial pressure curve taking age, gender, height and weigth into account."|Two measurements; one measurement during anaesthesia-induced hypotension (mean arterial pressure < 65 mmHg) before administration of phenylephrine and one measurement 3-5 min after administration of phenylephrine.||||ml/min||Standard Deviation|Least Squares Mean
2545058|NCT02951273|Secondary|Changes in Internal Carotid Artery Blood Flow by Induction of Anaesthesia.|Unilateral internal carotid artery blood flow [ml/min] assessed by duplex ultrasound.|Two measurements; one measurement 5-10 min before induction of anaesthesia and one measurement 5-20 min after induction of anaesthesia.||||ml/min||95% Confidence Interval|Mean
2545059|NCT02951273|Primary|Changes in Internal Carotid Artery Blood Flow by Treatment of Anaesthesia-induced Hypotension|Unilateral internal carotid artery blood flow [ml/min] assessed by duplex ultrasound.|Two measurements; one measurement during anaesthesia-induced hypotension (mean arterial pressure < 65 mmHg) before administration of phenylephrine and one measurement 3-5 min after administration of phenylephrine.||||ml/min||95% Confidence Interval|Mean
2550637|NCT02829944|Secondary|Patient Satisfaction With Postoperative Analgesia on a 0-10 Scale|Score reported on a scale of 0-10, with 0 being not at all satisfied and 10 being completely satisfied|48 hours||||score on a scale||Inter-Quartile Range|Median
2545060|NCT02951052|Other Pre-specified|Number of Participants With Different Demographic Parameters for Inter-subject Variability|Blood samples were planned to be collected at indicated time points for PK analysis of CAB LA and RPV LA. Demographic parameters including, but not limited to, age, sex, race, body weight, body mass index, and relevant laboratory parameters were planned to be evaluated as potential predictors of inter subject variability for pharmacokinetic parameters.|Upto Week 48|PK Population. This was an exploratory Outcome Measure. Data will not be analyzed and reported.||||||
2545061|NCT02951052|Secondary|Change From Baseline in Individual Item Scores of HIVTSQc at Weeks 4b, 24 and 44|HIVTSQc is a 12 item questionnaire. The individual treatment change item scores on HIVTSQc scale are rated as +3 ('much more satisfied', 'much more convenient', 'much more flexible',etc.) to -3 ('much less satisfied', 'much less convenient', 'much less flexible', etc.). The higher the score, the greater the improvement in satisfaction with each aspect of treatment and the lower the score, the greater the deterioration in satisfaction with each aspect of treatment. LOCF was used as primary method of analysis. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline and Weeks 4b, 24 and 44|ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2545062|NCT02951052|Secondary|Change From 4b in Tolerability of Injection at Week 5, 40 and 41 Using Numeric Rating Scale (NRS) Within CAB LA+RPV LA Arm|The NRS questionnaire is used to assess the tolerability of injections in CAB LA+RPV LA arm only. The questionnaire consists of one single question and will assess maximum level of pain experienced with the most recent injections ranking from no pain (0) to extreme pain (10). Missing scores was imputed using LOCF.|Weeks 4b, 5, 40 and 41|ITT-E population. Only those participants with data available at the specified data points were analyzed|||Scores on a scale||Standard Deviation|Mean
2545063|NCT02951052|Secondary|"Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using General Acceptance Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire"|The ACCEPT questionnaire is a generic medication acceptance measure assessing how participants weigh advantages and disadvantages of long-term medication.The questionnaire consists of 25 items that capture six dimensions.3 questions that focus on general acceptance of study medication will be analyzed.Items on the scale are rated as 1-5 scores:1:totally disagree,2:somewhat disagree,3:somewhat agree, 4:totally agree and 5:I don't know.Total score of the dimension is calculated as the mean of the recoded items of the dimension and then linearly transformed to be on a scale from 0 to 100:score:Total Score=(mean of the recoded items in the dimension minus1)divided by2*100.LOCF was used as primary method of analysis.Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI.Baseline value is defined as the latest pre-treatment assessment with a non-missing value.Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value|Baseline and at Weeks 8, 24 and 48|ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||95% Confidence Interval|Mean
2545064|NCT02951052|Secondary|Change in Treatment Satisfaction Over Time Using HIVTSQ Change (HIVTSQc) at Week 48 in Q4W Arm|The HIVTSQ for total treatment satisfaction score is computed with 1-11 items. These 1-11 items are summed to produce a score with a possible range of -33 to 33. The item 12 in the scale will be calculated as an individual score.The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment.A score of 0 represents no change. A maximum of 5 items can be missing, the missing scores will be imputed with the mean of the completed item scores. If 6 or more items are missing, then the overall treatment satisfaction scale score should not be computed and will remain missing.LOCF was used as primary method of analysis. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Data has been presented with respect to actual treatment received to the participants|Week 48|ITT-E population. Only those participants with data available at the specified data points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2545065|NCT02951052|Secondary|Change From Baseline in Total Treatment Satisfaction Using HIV Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4b, 24 and 44|The HIVTSQ for total treatment satisfaction score is computed with 1-11 items. These 1-11 items are summed to produce a score with a possible range of -33 to 33. The item 12 in the scale will be calculated as an individual score.The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment.A score of 0 represents no change. A maximum of 5 items can be missing, the missing scores will be imputed with the mean of the completed item scores. If 6 or more items are missing, then the overall treatment satisfaction scale score should not be computed and will remain missing.LOCF was used as primary method of analysis. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. Data has been presented with respect to actual treatment received to the participants|Baseline and at Weeks 4b, 24 and 44|ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2545066|NCT02951052|Secondary|Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12)|The SF-12 questionnaire consists of 7 questions which measures the degree of general health status and mental health distress. Each question is scored 0-5, except for question 2 scored 0-3. The HRQoL using SF-12 for the total score, physical component summary (PCS) and the mental component summary (MCS) were assessed for the two treatment groups. Missing Total or the component scores was imputed using LOCF. The PCS/MCS are calculated using computer software purchased from QualityMetric (http://www.qualitymetric.com). The higher the score, the better will be the health status. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline and at Weeks 24 and 48|ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||95% Confidence Interval|Mean
2550638|NCT02829944|Secondary|Number of Subjects Experiencing Pruritus|Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable|48 hours||||score on a scale||Inter-Quartile Range|Mean
2545067|NCT02951052|Secondary|Change From Baseline in DISWO Using HATQoL|The HATQoL questionnaire was used to assess the health related QoL (HRQoL). It comprises of three dimensions: LISAT, medication worries (MEDWO) and disclosure worries (DISWO). The total imputed value score for DISWO is calculated on a 0-100 scale using the formula: DISWO 100=[100 divided by (20 minus 5)]*(DISWO minus 5). A response of 1 in DISWO score shows less medication worries all of the time and 5 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline and at Weeks 24 and 48|ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||95% Confidence Interval|Mean
2545068|NCT02951052|Secondary|Change From Baseline in HIV Medication, MEDWO Using HATQoL|The HATQoL questionnaire was used to assess the health related QoL (HRQoL). It comprises of three dimensions: LISAT, medication worries (MEDWO) and disclosure worries (DISWO). The total imputed value score for MEDWO is calculated on a 0-100 scale using the formula: MEDWO 100=[100 divided by (20 minus 5)]*(MEDWO minus 5). A response of 1 in MEDWO score shows less medication worries all of the time and 5 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline and at Weeks 24 and 48|ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||95% Confidence Interval|Mean
2545069|NCT02951052|Secondary|Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire|The HATQoL questionnaire was used to assess the health related QoL (HRQoL). It comprises of three dimensions: LISAT, medication worries (MEDWO) and disclosure worries (DISWO). The total imputed value score for LISAT is calculated on a 0-100 scale using the formula: LISAT 100=[100 divided by (20 minus 4)]*(LISAT minus 4). A response of 5 in LISAT score shows satisfaction all of the time and 1 as none of the time. The higher the score, the greater satisfaction to life and the less worry. The transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% confidence interval (CI).Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 24 and 48|ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||95% Confidence Interval|Mean
2545070|NCT02951052|Secondary|Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire in Q4W Arm|The PIN questionnaire explores the bother of pain at the injection site and injection site reactions(ISR), anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with the mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections.This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial.Scores range from 1 to 5, and questions are phrased in such a way as to ensure that 1 always equated with the most favourable perception of vaccination, and 5 the most unfavourable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.The score of a domain is calculated as the mean of all items with the domain.Higher scores represent worse perception of injection. LOCF was used as primary method of analysis|Weeks 5, 41 and 48|ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percentage of participants|||Number
2545071|NCT02951052|Secondary|Change From Week 5 in Dimension Scores Using Percerption of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) in Q4W Arm|The PIN questionnaire explores the bother of pain at the injection site and injection site reactions (ISR), anxiety before and after injection, willingness to receive an HIV injectable treatment the following visit and satisfaction with the mode of treatment administration of individuals receiving injection and perceptions of individuals associated with receiving injections.This measure contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial.Scores range from 1 to 5, and questions are phrased in such a way as to ensure that 1 always equated with the most favourable perception of vaccination, and 5 the most unfavourable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.The score of a domain is calculated as the mean of all items with the domain.Higher scores represent worse perception of injection. LOCFwas used as primary method of analysis|Week 5 and at Weeks 41 and 48|ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on the scale||Standard Deviation|Mean
2545072|NCT02951052|Secondary|Number of Participants With Phenotypic Resistance Using Baseline Third Agent Through Week 48|Plasma samples were collected from participants who met confirmed virologic withdrawal criteria to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Phenotypic Resistance data for the following drugs: CAB, DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented. Phenotypic resistance, partially sensitive, and Sensitive were defined based on FC value from Monogram as: resistance (FC>clinical higher cutoff/biologic cutoff), partially sensitive (FC <=clinical higher cutoff and > clinical lower cutoff), sensitive (FC <= clinical lower cutoff/biologic cutoff).|At the time of CVF|CVF Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2547286|NCT02909140|Secondary|Mean Time Taken to Perform Phacoemulsification in Each Arm||intraoperative|"Data was only collected for the Intracameral Mydriasis' arm. We analyzed data for 1 participant only because of lack of data for the other participant."|||seconds|||Number
2545073|NCT02951052|Secondary|Number of Participants With Genotypic Resistance Using Baseline Third Agent Through Week 48|Plasma samples were collected from participants who met confirmed virologic withdrawal criteria to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Genotypic Resistance data for the following drugs: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented.|At the time of CVF|CVF Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2545074|NCT02951052|Secondary|Change From Baseline Values for Fasting Lipid Panel Using Baseline Third Agent Treatment Class Overtime Including Week 48|Blood samples were collected for the analysis of fasting lipid panel: triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Week 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2545075|NCT02951052|Secondary|Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48|Blood samples were collected for the analysis of clinical chemistry parameters: CO2, chloride, glucose, phosphate, potassium, sodium and urea to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2545076|NCT02951052|Secondary|Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Lipase|Blood samples were collected for the analysis of clinical chemistry parameter: lipase to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Units per liter||Standard Deviation|Mean
2545077|NCT02951052|Secondary|Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance|Blood samples were collected for the analysis of clinical chemistry parameter: creatinine clearance to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). GFR will be estimated by the central laboratory using the CKD-EPI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Milliliters per minute per 1.73meter^2||Standard Deviation|Mean
2545078|NCT02951052|Secondary|Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Bilirubin, Direct Bilirubin and Creatinine|Blood samples were collected for the analysis of clinical chemistry parameter: bilirubin, direct bilirubin and creatinine to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2545079|NCT02951052|Secondary|Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Albumin|Blood samples were collected for the analysis of clinical chemistry parameter: albumin to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Grams per Liter||Standard Deviation|Mean
2545080|NCT02951052|Secondary|Change From Baseline Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: ALT, ALP, AST and CK|Blood samples were collected for the analysis of clinical chemistry parameters: ALT, ALP, AST and CK to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||International units per liter||Standard Deviation|Mean
2545081|NCT02951052|Secondary|Number of Participants With Severity of Adverse Events by Baseline Third Agents|Severity of AEs were defined as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Severity grades for AEs were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 were all deaths related to an AE.|Up to Week 48|Safety population.|||Participants|||Count of Participants
2545139|NCT02951052|Secondary|Change From Baseline Values for Plasma HIV-1 RNA|Plasma for quantitative HIV-1 RNA were collected at indicated time points. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as: HIV-1 RNA(log 10) at Week 48 - HIV-1 RNA(log 10) at Baseline.|Baseline and Week 48|ITT-E population. Only those participants with data available at the specified data points were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2545082|NCT02951052|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50copies/mL Using Snapshot Algorithm by Baseline Third Agent|Percentage of participants with HIV-1 RNA < 50copies/mL endpoint as per FDA snapshot algorithm at Week 48 was assessed based on the non-inferior antiviral activity of switching IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART regimen over 48 weeks in HIV-1 infected ART-experienced participants. The HIV-RNA <50 copies/mL per snapshot algorithm was determined using a Cochran-Mantel Haenszel test stratified by baseline third agent class: INI, NNRTI, or PI.|Week 48|ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percentage of participants|||Number
2545083|NCT02951052|Secondary|Percentage of Participants With a Virologic Failure Using Snapshot Algorithm by Baseline Third Agent|Percentage of participants with virologic failure endpoint as per FDA snapshot algorithm at Week 48 was assessed based on the non-inferior antiviral activity of switching IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART regimen over 48 weeks in HIV-1 infected ART-experienced participants. The HIV-RNA >=50 copies/mL per snapshot algorithm was determined using a Cochran-Mantel Haenszel test stratified by baseline third agent class: INI, NNRTI, or PI.|Week 48|ITT-E population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percentage of participants|||Number
2545084|NCT02951052|Secondary|Cmax in Plasma for RPV LA Evaluable at Week 41|Blood samples will be collected at indicated time points for PK analysis of RPV LA.|Week 41- 1 Week post dose|PK population. Only those participants with data available at the specified data points were analyzed.|||Nanograms per milliliter||95% Confidence Interval|Geometric Mean
2545085|NCT02951052|Secondary|Maximum Concentration (Cmax) in Plasma for CAB LA Evaluable at Week 41|Blood samples will be collected at indicated time points for PK analysis of CAB LA.|Week 41- 1 Week post dose|PK population. Only those participants with data available at the specified data points were analyzed.|||Micrograms per milliliter||95% Confidence Interval|Geometric Mean
2545086|NCT02951052|Secondary|AUC for RPV LA|AUC values are Bayesian PK parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201585 and 201584 # NCT02938520. Blood samples from the current study 201585 were collected at indicated time points to analyze concentration in plasma for RPV LA.|Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5 and 41|PK population. Only those participants with data available at the specified data points were analyzed.|||Hours*nanogram per milliliter||95% Confidence Interval|Geometric Mean
2545087|NCT02951052|Secondary|Area Under the Curve (AUC) for CAB LA|AUC values are Bayesian PK parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201585 and 201584 # NCT02938520. Blood samples from the current study 201585 were collected at indicated time points to analyze concentration in plasma for CAB LA.|Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5 and 41|PK population. Only those participants with data available at the specified data points were analyzed.|||Hours*microgram per milliliter||95% Confidence Interval|Geometric Mean
2545088|NCT02951052|Secondary|Ctrough for RPV LA Evaluable|Blood samples will be collected at indicated time points for PK analysis of RPV LA.|Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|PK population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Nanograms per milliliter||95% Confidence Interval|Geometric Mean
2545089|NCT02951052|Secondary|Plasma Trough Concentration (Ctrough) for CAB LA Evaluable|Blood samples will be collected at indicated time points for pharmacokinetic (PK) analysis of CAB LA. PK population includes all participants who received CAB and / or RPV and underwent PK sampling during the study, and provided CAB and /or RPV plasma concentration data.|Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|PK population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Micrograms per milliliter||95% Confidence Interval|Geometric Mean
2545090|NCT02951052|Secondary|Number of Participants Discontinued or Withdrawn Due to AEs When Baseline Third Agent Treatment Class Was Used Over Time Including Week 48|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.|Up to Week 48|Safety population.|||Participants|||Count of Participants
2545091|NCT02951052|Secondary|Absolute Values for Fasting Lipid Panel Using Baseline Third Agent Treatment Class Overtime Including Week 48|Blood samples were collected for the analysis of fasting lipid panel: triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).|Baseline (Day 1) and at Week 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2545092|NCT02951052|Secondary|Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48|Blood samples were collected for the analysis of clinical chemistry parameters: CO2, chloride, glucose, phosphate, potassium, sodium and urea to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2545093|NCT02951052|Secondary|Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Lipase|Blood samples were collected for the analysis of clinical chemistry parameter: lipase to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Units per liter||Standard Deviation|Mean
2545137|NCT02951052|Secondary|Change From Baseline Values for CD4+ Lymphocyte Count at Week 48|Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to current ART.Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value at Week 48 minus Baseline value.|Baseline (Day 1) and Week 48|ITT-E population. Only those participants with data available at the specified data points were analyzed.|||Cells per cubic millimeter||Standard Deviation|Mean
2545094|NCT02951052|Secondary|Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Creatinine Clearance|Blood samples were collected for the analysis of clinical chemistry parameter: creatinine clearance to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI). GFR will be estimated by the central laboratory using the CKD-EPI.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Milliliters per minute per 1.73meter^2||Standard Deviation|Mean
2545095|NCT02951052|Secondary|Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Bilirubin, Direct Bilirubin and Creatinine|Blood samples were collected for the analysis of clinical chemistry parameter: bilirubin, direct bilirubin and creatinine to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2545096|NCT02951052|Secondary|Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: Albumin|Blood samples were collected for the analysis of clinical chemistry parameter: albumin to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Grams per Liter||Standard Deviation|Mean
2545097|NCT02951052|Secondary|Absolute Values for Clinical Chemistry Parameters Using Baseline Third Agent Treatment Class Overtime Including Week 48: ALT, ALP, AST and CK|Blood samples were collected for the analysis of clinical chemistry parameters to assess the impact of Baseline third agent treatment class (PI, NNRTI and INI).|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||International units per liter||Standard Deviation|Mean
2545098|NCT02951052|Secondary|Number of Participants With AEs by Using Baseline Third Agent Treatment Class Overtime Including Week 48|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.|Up to Week 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2545099|NCT02951052|Secondary|Number of Participants With Genotypic Resistance Through Week 48|Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. Genotypic Resistance data for the following drugs: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented.|At the time of CVF|CVF Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2545100|NCT02951052|Secondary|Number of Participants With Phenotypic Resistance Through Week 48|Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria.The CVF population comprised of all participants in ITT-E population who met CVF criteria.Phenotypic Resistance data for following drugs:CAB,dolutegravir(DTG),elvitegravir(EVG), raltegravir(RAL),delavirdine(DLV),efavirenz(EFV),etravirine(ETR),nevirapine(NVP),RPV,lamivudine(3TC),abacavir(ABC),emtricitabine(FTC),tenofovir(TDF),zidovudine(ZDV),stavudine(d4T),didanosine(ddI), atazanavir(ATV),darunavir(DRV),fosamprenavir(FPV),indinavir(IDV),lopinavir(LPV),nelfinavir(NFV),rito-navir(RTV),saquinavir(SQV) and tipranavir(TPV) in participants meeting CVF criteria is presented.Phenotypic resistance, partially sensitive, and Sensitive were defined based on fold change(FC) value from Monogram as:resistance(FC>clinical higher cutoff/biologic cutoff),partially sensitive(FC <=clinical higher cutoff and > clinical lower cutoff),sensitive(FC <= clinical lower cutoff/biologic cutoff).|At the time of CVF|CVF Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2545101|NCT02951052|Secondary|Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48|Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Percentage change from Baseline is calculated as: value at Week 48 minus Baseline value divided by Baseline value multiplied by 100.|Baseline (Day 1) and at Week 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent change||Standard Deviation|Mean
2545102|NCT02951052|Secondary|Number of Participants Who Discontinued or Withdrawn Due to AEs Over Time Including Week 48|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.|Up to Week 48|Safety population.|||Participants|||Count of Participants
2545103|NCT02951052|Secondary|Change From Baseline Values in Urine pH Over Time Including Week 48|Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). The dipstick test gives results in a semi-quantitative manner. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 24 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||pH||Standard Deviation|Mean
2545138|NCT02951052|Secondary|Absolute Values for CD4+ Lymphocyte Count at Week 48|Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to current ART.|Week 48|ITT-E population. Only those participants with data available at the specified data points were analyzed.|||Cells per cubic millimeter||Standard Deviation|Mean
2545104|NCT02951052|Secondary|Change From Baseline Values in Urine Specific Gravity Over Time Including Week 48|Urine biomarker samples were collected for the analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The dipstick test gives results in a semi-quantitative manner. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. The urine specific gravity was measured as the ratio of urine density compared with water density.|Baseline (Day 1) and at Weeks 4, 24 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Ratio of urine density to water density||Standard Deviation|Mean
2545105|NCT02951052|Secondary|Change From Baseline Values in Urine Retinol Binding Protein Over Time Including Week 48|Urine biomarker samples were collected for the analysis of urine retinol binding protein. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Week 48|Safety population. Only those participants with data available at the specified data points were analyzed.|||Nanomoles per liter||Standard Deviation|Mean
2545106|NCT02951052|Secondary|Change From Baseline Values in Urine Phosphate Over Time Including Week 48|Urine biomarker samples were collected for the analysis of urine phosphate. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 24 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2545107|NCT02951052|Secondary|Change From Baseline Values in Urine Creatinine Over Time Including Week 48|Urine biomarker samples were collected for the analysis of urine creatinine. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 24 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2545108|NCT02951052|Secondary|Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48|Urine biomarker samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio.Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 24 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Grams per mole||Standard Deviation|Mean
2545109|NCT02951052|Secondary|Change From Baseline Values for Fasting Lipid Panel Over Time Including Week 48|Blood samples were collected for the analysis of fasting lipid parameters- total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Week 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2545110|NCT02951052|Secondary|Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance.|Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance. GFR will be estimated by the central laboratory using the CKD-EPI. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Milliliters per minute per 1.73meter^2||Standard Deviation|Mean
2545111|NCT02951052|Secondary|Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase|Blood samples were collected for the analysis of clinical chemistry parameter-lipase. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Units per liter||Standard Deviation|Mean
2545112|NCT02951052|Secondary|Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48|Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2545113|NCT02951052|Secondary|Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine|Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2545140|NCT02951052|Secondary|Absolute Values for Plasma HIV-1 RNA at Week 48|Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented.|Week 48|ITT-E population. Only those participants with data available at the specified data points were analyzed|||log10 copies/mL||Standard Deviation|Mean
2545114|NCT02951052|Secondary|Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin|Blood samples were collected for the analysis of clinical chemistry parameter-albumin. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2545115|NCT02951052|Secondary|Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK|Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK. Baseline values is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||International units per liter||Standard Deviation|Mean
2545116|NCT02951052|Secondary|Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48|Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).|Baseline (Day 1) and at Weeks 4, 24 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2545117|NCT02951052|Secondary|Number of Participants With Abnormal Urinalysis Parameters Over Time Including Week 48|The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters (ketones, glucose, bilirubin, occult blood, nitrite and blood protein) can be read as positive, trace, 1+, 2+, 3+ and 4+ indicating proportional concentrations in the urine sample. The urine parameters were graded according to Division of AIDS (DAIDS) scale where Grade 1 indicates mild (trace to 1+), Grade 2 indicates moderate (2+) and Grade 3 indicates severe (3+ or higher). Only participants with abnormal findings for urinalysis at any visit has been presented.|Baseline (Day 1) and at Weeks 4, 24 and 48.|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2545118|NCT02951052|Secondary|Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance|Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance at indicated timepoints. Glomerular filtration rate (GFR) will be estimated by the central laboratory using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Milliliter per minute per 1.73meter^2||Standard Deviation|Mean
2545119|NCT02951052|Secondary|Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase|Blood samples were collected for the analysis of clinical chemistry parameter-lipase at indicated time points.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Units per liter||Standard Deviation|Mean
2545120|NCT02951052|Secondary|Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48|Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea at indicated time points.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2545121|NCT02951052|Secondary|Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine|Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin at indicated time points.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2545122|NCT02951052|Secondary|Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin|Blood samples were collected for the analysis of clinical chemistry parameter-albumin at indicated time points.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2545123|NCT02951052|Secondary|Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK)|Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||International units per liter||Standard Deviation|Mean
2545124|NCT02951052|Secondary|Change From Baseline for Hematology Parameters: Hemoglobin|Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2545240|NCT02949011|Secondary|Percentage of Participants Requiring Systemic Antibiotics for Infections Secondary to Influenza Infection|The percentage of participants who received systemic antibiotics for any of the predefined complications (sinusitis, otitis media, bronchitis and pneumonia).|Day 2 to Day 22|Intention-to-treat infected population|||percentage of participants||95% Confidence Interval|Number
2545125|NCT02951052|Secondary|Change From Baseline for Hematology Parameters: Hematocrit|Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Proportion of red blood cells in blood||Standard Deviation|Mean
2545126|NCT02951052|Secondary|Change From Baseline for Hematology Parameters: Erythrocytes|Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||10^12 cells per liter||Standard Deviation|Mean
2545127|NCT02951052|Secondary|Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume|Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Femtoliters||Standard Deviation|Mean
2545128|NCT02951052|Secondary|Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets|Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated timepoints. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||10^9 cells per liters||Standard Deviation|Mean
2545129|NCT02951052|Secondary|Absolute Values for Hematology Parameters: Hematocrit|Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated time points.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Proportion of red blood cells in blood||Standard Deviation|Mean
2545130|NCT02951052|Secondary|Absolute Values for Hematology Parameters: Hemoglobin|Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated time points.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2545131|NCT02951052|Secondary|Absolute Values for Hematology Parameters: Erythrocytes|Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated time points.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||10^12 cells per liter||Standard Deviation|Mean
2545132|NCT02951052|Secondary|Absolute Values for Hematology Parameters: Erythrocyte Mean Corpuscular Volume|Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated time points.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Femtoliters||Standard Deviation|Mean
2545133|NCT02951052|Secondary|Absolute Values for Hematology Parameters Over Time Including Week 48: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets|Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated time points.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||10^9 cells per liter||Standard Deviation|Mean
2545134|NCT02951052|Secondary|Number of Participants With Severity of Adverse Events|Severity of adverse events (AEs) were defined as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 2.0, November 2014. Severity grades for AEs were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 were all deaths related to an AE.|Up to Week 48|Safety Population|||Participants|||Count of Participants
2545135|NCT02951052|Secondary|Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. Safety Population comprised of all randomized participants who received at least one dose of IP during the maintenance phase of the study (on or after Day 1 visit). Participants will be assessed according to actual treatment received.|Up to Week 48|Safety Population|||Participants|||Count of Participants
2545136|NCT02951052|Secondary|Number of Participants With Disease Progression|Disease progression was defined as HIV-associated conditions, acquired immunodeficiency syndrome (AIDS), and death through 48 Weeks. Data of participants who experienced disease progression to Centers for Disease Control and Prevention (CDC) Stage III or death has been presented.|Up to Week 48|ITT-E Population|||Participants|||Count of Participants
2545141|NCT02951052|Secondary|Number of Participants With Confirmed Virologic Failure (CVF)|The CVF is defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels >=200 copies/mL after prior suppression to <200 copies/mL. The outcome displays only visits during which at least one new CVF occurs. Plasma samples were collected for quantitative analysis of HIV-1 RNA.|Weeks 8, 12, 20, 24, 32 and 40|ITT-E Population|||Participants|||Count of Participants
2545142|NCT02951052|Secondary|Number of Participants With HIV-1 RNA <200 Copies/mL Using Snapshot Algorithm at Week 48|Number of participants with plasma HIV-1 RNA <200 copies/mL at Week 48 using the snapshot algorithm was assessed based on the antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART.|Week 48|ITT-E Population|||Participants|||Count of Participants
2545143|NCT02951052|Secondary|Number of Participants With HIV-1 RNA <50 Copies/mL Using Snapshot Algorithm at Week 48|Plasma samples were collected for quantitative analysis of HIV-1 RNA. Number of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 using FDA snapshot algorithm was assessed to demonstrate antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of current ART. The HIV-1 RNA <50 copies/mL per snapshot algorithm was determined by the last available on-treatment HIV-1 RNA measurement within the analysis visit window of interest.|Week 48|ITT-E Population|||Participants|||Count of Participants
2545144|NCT02951052|Primary|Number of Participants With Virologic Failure (HIV-1 Ribonucleic Acid [RNA] >=50 Copies Per Millilter [mL]) Using Snapshot Algorithm at Week 48|Number of participants with virologic failure endpoint (HIV-1 RNA>=50 c/mL) as per Food and Drug Administration (FDA) snapshot algorithm at Week 48 was assessed to demonstrate the non-inferior antiviral activity of switching to intramuscular (IM) CAB LA+RPV LA every 4 weeks compared to continuation of current ART regimen over 48 weeks in HIV-1 infected ART-experienced participants. The HIV-1 RNA >=50 copies/mL per snapshot algorithm was determined by the last available on-treatment HIV-1 RNA measurement within the analysis visit window of interest.|Week 48|Intent-to treat exposed (ITT-E) participants included all randomized participants who received at least one dose of Investigational Product (IP) during the maintenance phase. Participants were analyzed according to the randomized treatment regardless of what treatment actually received.|||Participants|||Count of Participants
2545145|NCT02950896|Primary|ECG of Fetal Heart Rate|This measure will be compared to the acoustic monitoring of FHR across the same 10 minutes.|10 minutes of evaluable ECG reading|The study was terminated and no results were analyzed.||||||
2545146|NCT02950831|Secondary|Change in Sleep Quality|Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.|between baseline and 3 month post permanent spinal cord stimulator activation followup|Percent change in average sleep duration from baseline value is reported. Activity files were not available for 5 patients|||Change h/day from baseline value||Standard Deviation|Mean
2545147|NCT02950831|Secondary|Change in Activity Levels|"Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day.~Average percent change in MVPA from baseline value is reported."|between baseline and 3 month post permanent spinal cord stimulator activation followup|Average change in MVPA (h/day) from baseline value is reported. Activity files were not available for 5 patients|||change in MVPA h/day from baseline value||Standard Deviation|Mean
2545148|NCT02950831|Secondary|Change in Sleep Quality|Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.|between baseline and 2 month post permanent spinal cord stimulator activation followup|Change in average sleep duration from baseline value is reported. Activity recording files were not available for 1 patient|||Change h/day from baseline value||Standard Deviation|Mean
2545149|NCT02950831|Secondary|Change in Activity Levels|"Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day.~Average percent change in MVPA from baseline value is reported."|between baseline and 2 month post permanent spinal cord stimulator activation followup|Average change in MVPA (h/day) from baseline value is reported. Activity recording files were not available for 1 patient|||change in MVPA h/day from baseline value||Standard Deviation|Mean
2545150|NCT02950831|Secondary|Change in Sleep Quality|Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.|between baseline and 1 month post permanent spinal cord stimulator activation followup|Change in average sleep duration from baseline value is reported. Activity recording files were not available for 1 patient|||Change h/day from baseline value||Standard Deviation|Mean
2545151|NCT02950831|Secondary|Change in Activity Levels|"Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day.~Average percent change in MVPA from baseline value is reported."|between baseline and 1 month post permanent spinal cord stimulator activation followup|Average change in MVPA (h/day) from baseline value is reported. Activity recording files were not available for 1 patient|||change in MVPA h/day from baseline value||Standard Deviation|Mean
2545152|NCT02950831|Secondary|Change in Oswestry Disability Index (ODI)|Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability.|between baseline and 3 month post permanent spinal cord stimulator activation followup|Change in average ODI value from baseline is reported.|||change in score on a scale||Standard Deviation|Mean
2545153|NCT02950831|Secondary|Change in Oswestry Disability Index (ODI)|Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability.|between baseline and 2 month post permanent spinal cord stimulator activation followup|Change in average ODI value from baseline is reported.|||change in score on a scale||Standard Deviation|Mean
2545154|NCT02950831|Secondary|Change in Oswestry Disability Index (ODI)|Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability.|between baseline and 1 month post permanent spinal cord stimulator activation followup|Change in average ODI value from baseline is reported.|||change in score on a scale||Standard Deviation|Mean
2545259|NCT02948634|Secondary|Global Rating of Change Scale|Self report tool describing the degree of change since baseline. Minimum/worse value is -7. Maximum/best value is +7.|1 week and 1 month after treatment||||score on a scale||Standard Deviation|Mean
2545155|NCT02950831|Secondary|Change in Oswestry Disability Index (ODI)|Questionnaire pertaining to disability levels. Minimum value 0, maximum value 100 with higher values representing higher levels of disability.|between baseline and the end of spinal cord stimulation trial period (average of 1 month)|Percentage change in average ODI value from baseline is reported. One patient did not complete the ODI form correctly.|||change in score on a scale||Standard Error|Mean
2545156|NCT02950831|Secondary|Change in European Quality of Life 5 Dimensions (EQ-5D)|Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life|between baseline and 3 month post permanent spinal cord stimulator activation followup|Change in average EQ-5D scores from baseline is reported|||change in score on a scale||Standard Deviation|Mean
2545157|NCT02950831|Secondary|Change in European Quality of Life 5 Dimensions (EQ-5D)|Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life|between baseline and 2 month post permanent spinal cord stimulator activation followup|Change in average EQ-5D scores from baseline is reported|||change in score on a scale||Standard Deviation|Mean
2545158|NCT02950831|Secondary|Change in European Quality of Life 5 Dimensions (EQ-5D)|Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life|between baseline and 1 month post permanent spinal cord stimulator activation followup|Change in average EQ-5D scores from baseline is reported|||change in score on a scale||Standard Deviation|Mean
2545159|NCT02950831|Secondary|Change in European Quality of Life 5 Dimensions (EQ-5D)|Questionnaire pertaining to quality of life. Minimum Value 0, maximum value 1 with higher numbers representing higher quality of life.|between baseline and the end of spinal cord stimulation trial period (average of 1 month)|Change in average EQ-5D scores from baseline is reported|||change in score on a scale||Standard Deviation|Mean
2545160|NCT02950831|Secondary|Change in Visual Analog Scale (VAS) for Pain|Subjective evaluation of pain levels used in clinical practice as standard. Minimum value is 0 (no pain), maximum value is 10 (maximum pain imaginable)|between baseline and 3 month post permanent spinal cord stimulator activation followup|Percentage change in average VAS value from baseline is reported (pain relief)|||Percentage change from baseline score||Standard Deviation|Mean
2545161|NCT02950831|Secondary|Change in Visual Analog Scale (VAS) for Pain|Subjective evaluation of pain levels used in clinical practice as standard. Minimum value is 0 (no pain), maximum value is 10 (maximum pain imaginable)|between baseline and 2 month post permanent spinal cord stimulator activation followup|Percentage change in average VAS value from baseline is reported (pain relief)|||Percentage reduction from baseline score||Standard Deviation|Mean
2545162|NCT02950831|Secondary|Change in Visual Analog Scale (VAS) for Pain|Subjective evaluation of pain levels used in clinical practice as standard. Minimum value is 0 (no pain), maximum value is 10 (maximum pain imaginable)|between baseline and 1 month post permanent spinal cord stimulator activation followup|Percentage reduction in average VAS value from baseline is reported (pain relief)|||Percentage change from baseline score||Standard Error|Mean
2545163|NCT02950831|Secondary|Change in Visual Analog Scale (VAS) for Pain|Subjective evaluation of pain levels used in clinical practice as standard. Minimum value is 0 (no pain), maximum value is 10 (maximum pain imaginable)|between baseline and the end of spinal cord stimulation trial period (average of 1 month)|Percentage change in average VAS value from baseline is reported (pain relief) Data was not available for 1 subject|||Percentage reduction from baseline score||Standard Error|Mean
2545164|NCT02950831|Primary|Change in Sleep Quality|Recording performed with wrist worn accelerometer. Sleep duration was calculated based on accelerometry data.|between baseline and the end of spinal cord stimulation trial period (average of 1 month)|Change in average sleep duration from baseline value is reported. Activity recording files were not available for 2 patients.|||Change h/day from baseline value||Standard Deviation|Mean
2545165|NCT02950831|Primary|Change in Activity Levels|Recording performed with wrist worn accelerometer. Medium to Vigorous Physical Activity (MVPA) were calculated based on accelerometry data. MVPA value represents the hours of medium to vigorous physical activity in a day.|between baseline and the end of spinal cord stimulation trial period (average of 1 month)|Average change in MVPA (h/day) from baseline value is reported. Activity recording files were not available for 2 patients.|||change in MVPA h/day from baseline value||Standard Deviation|Mean
2545166|NCT02950753|Secondary|Final Chloride Level Minus Initial Chloride Level of the LR Group Compared to the NS Group|Baseline serum chloride will be measured in both groups just prior to IV administration and again at 5 minutes after IV bolus has ended.|5 minutes after IV bolus has ended.||||mEq/L||Standard Deviation|Mean
2545167|NCT02950753|Secondary|Decrease in Bicarbonate Level of the LR Group Compared to the NS Group|Baseline serum bicarbonate will be measured in both groups just prior to IV administration and again at 5 minutes after IV bolus has ended.|5 minutes after IV bolus has ended.||||mEq/L||Standard Deviation|Mean
2545168|NCT02950753|Primary|Change in Mean Lactate Level of the LR Group Compared to the NS Group.|Final mean lactate minus initial mean lactate|5 minutes after IV bolus has ended.||||mmol/L||95% Confidence Interval|Mean
2545169|NCT02950545|Secondary|Operational Composite Score|This scale measures driving-relevant visual performance. It is the sum of the z scores from 5 different driving simulator variables related to visual testing done in the simulator. The scale has no fixed limits. A score of 0 indicates average performance. Higher scores indicate better performance.|1 day|All participants who completed the 3 simulated driving sessions and who had complete and accurate data records were included in the analysis.|||score on a scale||Standard Deviation|Mean
2545170|NCT02950545|Primary|Tactical Composite Score|This scale measures driving performance in the simulator. It is the sum of the z scores from 15 different driving simulator variables related to braking, steering, speed control and judgment. The scale has no fixed limits. A score of 0 indicates average performance. Higher scores indicate better performance.|1 day|All participants who completed the 3 simulated driving sessions and who had complete and accurate data records were included in the analysis.|||score on a scale||Standard Deviation|Mean
2545183|NCT02949921|Secondary|Percentage of Participants With Global Aesthetic Improvement Scale (GAIS) Scores After Initial Treatment at Months 1 and 6|The GAIS is a 7-point scale. The 7-point scale are as follows: +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse).|Months 1 and 6|All participants who were enrolled in the study.|||percentage of participants|||Number
2545171|NCT02950480|Secondary|Appearance of Capsular Contracture|The capsule tissue that is removed at the time of expander-implant exchange will be fixed and histologically assessed for the presence of fibroblasts and myofibroblasts.|After Day 44 to Day 126|No participants were analyzed due to a change in post-mastectomy reconstruction standard practice which implements pre-pectoral implants resulting in low accruals to the protocol. The study was closed prior to any measurements taken or histology analyzed as there would have been insufficient data to produce any statistically significant results.||||||
2545172|NCT02950480|Secondary|Histologic Analysis: Compare Capsular Thickness by Gross and Microscopic Measurement at the Time of Expander-implant Exchange in Those Treated With Zafirlukast (20 mg PO BID) Compared With Standard of Care|"Perform histologic analysis of the capsule specimens to compare overall fibrosis and collagen deposition between the zafirlukast and standard of care groups.~During expander-implant exchange, three representative sections of the expander capsule will be collected: medial, lateral and anterior capsule specimens. Gross and microscopic determination of capsule thickness will be performed by the pathology department. The Munster lab will fix and stain the tissues to look for the presence of collagen, level of fibrosis, and number of myofibroblasts. Fibrosis level and collagen presence will be determined by performing immunohistochemistry with a Trichrome stain of the tissues, as well as Western blot analysis with Collagen-1. Myofibroblasts will be detected using immunohistochemistry with commercially available antibodies."|Day 44 to Day 126|No participants were analyzed due to a change in post-mastectomy reconstruction standard practice which implements pre-pectoral implants resulting in low accruals to the protocol. The study was closed prior to any measurements taken or histology analyzed as there would have been insufficient data to produce any statistically significant results.||||||
2545173|NCT02950480|Primary|Capsular Thickness|Compare capsular thickness by gross and microscopic measurement at the time of expander-implant exchange in those treated with zafirlukast (20 mg PO BID) compared with standard of care.|Day 44 to Day 126|No participants were analyzed due to a change in post-mastectomy reconstruction standard practice which implements pre-pectoral implants resulting in low accruals to the protocol. The study was closed prior to any measurements taken or histology analyzed as there would have been insufficient data to produce any statistically significant results.||||||
2545174|NCT02950025|Secondary|Number of Participants With Local Failure||At six month follow-up (approximately 6 months and 2 weeks)||||Participants|||Count of Participants
2545175|NCT02950025|Secondary|Patient Reported Overall Quality of Life During the Past Week as Measured by EORTC QLQ-C30 Quality of Life|"Utilize both paired t-tests and repeated measures ANOVA to analyze QOL data (this was unable to be performed due to the small sample size)~The question asked the participant how would you rate your quality of life during the past week?~The scale ranges from 1=very poor to 7 = excellent. The higher the score the better the quality of life."|Pre-treatment, six-weeks post treatment, and six months post-treatment||||score on a scale||Full Range|Mean
2545176|NCT02950025|Secondary|Overall Survival (OS) Rate|"Overall survival rate - number of participants alive at the six-month follow-up~Please note that the planned statistical analysis wasn't able to be performed due to small sample size: Utilizing Kaplan-Meier methodology."|At six month follow-up (approximately 6 months and 2 weeks)||||Participants|||Count of Participants
2545177|NCT02950025|Secondary|Disease Free Survival Rate|"Disease free survival rate = the number of participants who are disease free (without any signs or symptoms of cancer) at the six-month follow-up~Please note that the planned statistical analysis wasn't able to be performed due to small sample size: Utilizing Kaplan-Meier methodology."|At six month follow-up (approximately 6 months and 2 weeks)||||Participants|||Count of Participants
2545178|NCT02950025|Secondary|Progression-free Survival (PFS) Rate|"PFS rate - the number of participants who have not progressed and/or died at the six-month follow-up~Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Please note that the planned statistical analysis wasn't able to be performed due to small sample size: Utilizing Kaplan-Meier methodology"|At six month follow-up (approximately 6 months and 2 weeks)-up||||Participants|||Count of Participants
2545179|NCT02950025|Secondary|Tumor Response Rate|"Tumor response rate = rate of participants who have complete or partial response at the six month follow-up~Complete Response (CR): Disappearance of the target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the (sum of the) diameter of the target lesion(s), taking as reference the baseline sum diameters."|At six month follow-up (approximately 6 months and 2 weeks)||||Participants|||Count of Participants
2545180|NCT02950025|Primary|Number of Grade 3 or Greater Toxicity Occurring in Patients Receiving Online, Adaptive, MRI-guided SBRT to the Abdomen and in Patients Receiving Non-adaptive SBRT|"The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.~Grade 3 or higher toxicities that did not predate SBRT and are probably or definitely attributable to treatment~Please note that the following statistical analysis was not performed due to small sample size: Statistical analysis will be powered to detect a reduction of toxicity from 35% Grade 3 or greater toxicity to 10% Grade 3 or greater toxicity using online-adaptive therapy. Statistical analysis will be one-sided test for independent proportions."|Up through 6 months post-treatment (approximately 6 months and 2 weeks)||||adverse event|||Number
2545181|NCT02949947|Primary|Complete Response Rate in Hemoglobin (HGB)|The primary endpoint is response (CR rate) in HGB within 3 months. Participant considered as to have a complete response (CR) if his/her HGB level increases > 2 g/dL from baseline during 3 months following initiation of the study drug, and/or transfusion-dependent patient is transfusion free.|3 months|Due to early termination of the protocol and low accrual not enough data collected to analyze the Complete Response Rate in Hemoglobin.||||||
2545182|NCT02949921|Secondary|Percentage of Participants With GAIS Scores Following Retreatment at Months 7 and 12|The GAIS is a 7-point scale. The 7-point scale are as follows: +3 (very much improved); +2 (much improved); +1 (improved); 0 (no change); -1 (worse); -2 (much worse); -3 (very much worse).|Months 7 and 12|All participants who were enrolled in the study. Participants who were evaluable for this measure at given time period were included in the assessment.|||percentage of participants|||Number
2545184|NCT02949921|Secondary|Number of Participants With >=1 Point Improvement on the MHGS in Both Hands Following Retreatment at Months 7 and 12|"The MHGS was used to measure clinical efficacy of the Radiesse hand treatments by a masked evaluator performing live, dorsal hand assessments. The MHGS was an ordinal scale; therefore, ratings were made based on a snap-shot at a specific study time point. A measure of successful or improved treatment effect was demonstrated by a decrease in MHGS score. MHGS had 5 categories, where: 0 (no loss of fatty tissue); 1 (mild loss of fatty tissue; slight visibility of veins); 2 (moderate loss of fatty tissue; mild visibility of veins and tendons); 3 (severe loss of fatty tissue; moderate visibility of veins and tendons); 4(very severe loss of fatty tissue; marked visibility of veins and tendons)."|Months 7 and 12|All participants who were enrolled in the study. Participants who were evaluable for this measure at given time period were included in the assessment.|||participants|||Number
2545185|NCT02949921|Secondary|Number of Participants With Greater Than or Equal to (>=) 1 Point Improvement on the MHGS in Both Hands After Initial Treatment at Months 1 and 6|"The MHGS was used to measure clinical efficacy of the Radiesse hand treatments by a masked evaluator performing live, dorsal hand assessments. The MHGS was an ordinal scale; therefore, ratings were made based on a snap-shot at a specific study time point. A measure of successful or improved treatment effect was demonstrated by a decrease in MHGS score. MHGS had 5 categories, where: 0 (no loss of fatty tissue); 1 (mild loss of fatty tissue; slight visibility of veins); 2 (moderate loss of fatty tissue; mild visibility of veins and tendons); 3 (severe loss of fatty tissue; moderate visibility of veins and tendons); 4(very severe loss of fatty tissue; marked visibility of veins and tendons)."|Months 1 and 6|All participants who were enrolled in the study.|||participants|||Number
2545186|NCT02949921|Secondary|Michigan Hand Outcomes Questionnaire (MHQ) Scores|The MHQ is a hand-specific outcomes instrument that measures outcomes of participants with conditions of, or injury to, the hand or wrist. The MHQ contains six domains: overall hand function, activities of daily living, work performance, pain, aesthetics and satisfaction. For this study, MHQ overall hand function and MHQ pain domains were evaluated. Scores for both scales range from 0-100. Higher MHQ hand function scores denote better hand performance whereas higher MHQ pain scores denote more pain. MHQ minimal clinically important differences were defined as score changes greater than an 11-point increase for the pain domain and greater than a 13-point decrease for the function domain.|Baseline, Months 1, 6, 7, 12, 13, 18, 19 and 24|All participants who were enrolled in the study. Participants who were evaluable for this measure at given time period were included in the assessment.|||units on a scale||Standard Deviation|Mean
2545187|NCT02949921|Secondary|Percentage of Participants Reporting One or More Device or Injection-related Severe Adverse Events (AEs) at Months 1 and 6||Months 1 and 6|All participants who were enrolled in the study.|||percentage of participants|||Number
2545188|NCT02949921|Primary|Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 24|Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.|Month 24|Participants who received 4 treatments in total (initial and 3 retreatments).|||participants|||Number
2545189|NCT02949921|Primary|Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 12|Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.|Month 12|Data was not calculated since no participant had bone obscuration at Month 6, and therefore no x-ray was taken at Month 12.||||||
2545190|NCT02949921|Primary|Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 6|Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.|Month 6|All participants who were enrolled in the study.|||participants|||Number
2545191|NCT02949921|Primary|Number of Participants With X-ray of Either Hand With Bone Obscuration at Month 1|Obscuration was defined as any post-treatment hand x-ray that at least 1 of the 2 blinded radiologist interpreted as Radiesse obscuring bones.|Month 1|All participants who were enrolled in the study.|||participants|||Number
2545192|NCT02949908|Secondary|Correlation Between Annualized Relapse Rate (ARR) and Treatment Adherence|ARR defined as the number of relapses per year. A relapse is defined as the appearance of a new clinical sign or symptom attributable to MS, or clinical worsening of a previous sign or symptom that had been stable for greater than or equal to (>=) 30 days and that persisted for >=24 hours without fever. According to the World Health Organization (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term).|up to 12 months|Correlation analysis was not performed because the study was terminated prematurely due to low participants recruitment (only 2 participants enrolled), which did not allow performance of the planned correlation statistical analysis.||||||
2545193|NCT02949908|Secondary|Change From Baseline in Annualized Relapse Rate (ARR) at Month 12|ARR defined as the number of relapses per year. A relapse is defined as the appearance of a new clinical sign or symptom attributable to MS, or clinical worsening of a previous sign or symptom that had been stable for greater than or equal to (>=) 30 days and that persisted for >=24 hours without fever.|Baseline, Month 12|Data was not analyzed for this outcome as the study terminated prematurely due to low subject enrollment and no data was collected for Month 12 assessment.||||||
2545194|NCT02949908|Secondary|Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscale Score at Month 6 and Month 12|TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across wide variety of medication types and illness conditions. It consists 11 question items used for computing 4 subscales: effectiveness, convenience, side effects and global satisfaction. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging 1-7, where 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied.|Baseline, Month 6, Month 12|Data was not analyzed because study terminated prematurely due to low participant recruitment (only 2 participants enrolled). Month 6 data was available for only 1 participant and none had data collected at Month 12, which did not allow performance of planned analysis. Overall score at Month 6 was collected and is reported under primary outcome 1.||||||
2545260|NCT02948634|Secondary|RAND 36-Item Health Survey|Pain Domain: 2 Questions, 0 minimum/worse score, 100 maximum/best score|baseline, 1 week, and 1 month after treatment||||score on a scale||Standard Deviation|Mean
2545195|NCT02949908|Secondary|Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscales and Reasons for Discontinuation|TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across wide variety of medication types and illness conditions. It consists 11 question items used for computing 4 subscales: effectiveness, convenience, side effects and global satisfaction. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging 1-7, where 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Reasons of discontinuation of initial MS treatment were reported.|up to 12 months|Correlation analysis was not performed because the study was terminated prematurely due to low participants recruitment (only 2 participants enrolled), which did not allow performance of the planned correlation statistical analysis.||||||
2545196|NCT02949908|Secondary|Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscales and Adherence|TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across wide variety of medication types and illness conditions. It consists 11 question items used for computing 4 subscales: effectiveness, convenience, side effects and global satisfaction. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging 1-7, where 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. According to the World Health Organization (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term).|up to 12 months|Correlation analysis was not performed because the study was terminated prematurely due to low participants recruitment (only 2 participants enrolled), which did not allow performance of the planned correlation statistical analysis.||||||
2545197|NCT02949908|Secondary|Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Reason for Discontinuation|The MusiQoL is a disease-specific validated 31-item multi-dimensional, self-administered questionnaire. Participants were asked to assess their level of satisfaction with the treatment. Question was answered using a 6-point Likert scale, defined as 1-Never/Not at all, 2-Rarely/A little, 3-Sometimes/Somewhat, 4-Often/A lot, 5-Always/Very much and 6-Not applicable. Reasons of discontinuation of initial MS treatment were reported.|up to 12 months|Correlation analysis was not performed because the study was terminated prematurely due to low participants recruitment (only 2 participants enrolled), which did not allow performance of the planned correlation statistical analysis.||||||
2545198|NCT02949908|Secondary|Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Adherence|The MusiQoL is a disease-specific validated 31-item multi-dimensional, self-administered questionnaire. Participants were asked to assess their level of satisfaction with the treatment. Question was answered using a 6-point Likert scale, defined as 1-Never/Not at all, 2-Rarely/A little, 3-Sometimes/Somewhat, 4-Often/A lot, 5-Always/Very much and 6-Not applicable. According to the World Health Organization (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term).|up to 12 months|Correlation analysis was not performed because the study was terminated prematurely due to low participants recruitment (only 2 participants enrolled), which did not allow performance of the planned correlation statistical analysis.||||||
2545199|NCT02949908|Secondary|Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Annualized Relapse Rate (ARR)|The MusiQoL is a disease-specific validated 31-item multi-dimensional, self-administered questionnaire. Participants were asked to assess their level of satisfaction with the treatment. Question was answered using a 6-point Likert scale, defined as 1-Never/Not at all, 2-Rarely/A little, 3-Sometimes/Somewhat, 4-Often/A lot, 5-Always/Very much and 6-Not applicable. ARR= number of relapses per year. Relapse= the appearance of a new clinical sign or symptom attributable to MS, or clinical worsening of a previous sign or symptom that had been stable for greater than or equal to (>=) 30 days and that persisted for >=24 hours without fever.|up to 12 months|Correlation analysis was not performed because the study was terminated prematurely due to low participants recruitment (only 2 participants enrolled), which did not allow performance of the planned correlation statistical analysis.||||||
2545200|NCT02949908|Secondary|Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Reason for Discontinuation|TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across wide variety of medication types and illness conditions. It consists 11 question items. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging 1-7, where 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Reasons of discontinuation of initial MS treatment were reported.|up to 12 months|Correlation analysis was not performed because the study was terminated prematurely due to low participants recruitment (only 2 participants enrolled), which did not allow performance of the planned correlation statistical analysis.||||||
2545201|NCT02949908|Secondary|Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Adherence|TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across wide variety of medication types and illness conditions. It consists 11 question items. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging 1-7, where 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. According to the World Health Organization (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term).|up to 12 months|Correlation analysis was not performed because the study was terminated prematurely due to low participants recruitment (only 2 participants enrolled), which did not allow performance of the planned correlation statistical analysis.||||||
2545202|NCT02949908|Secondary|Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Annualized Relapse Rate (ARR)|TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across wide variety of medication types and illness conditions. It consists 11 question items. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging 1-7, where 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. ARR= number of relapses per year. Relapse= the appearance of a new clinical sign or symptom attributable to MS, or clinical worsening of a previous sign or symptom that had been stable for greater than or equal to (>=) 30 days and that persisted for >=24 hours without fever.|up to 12 months|Correlation analysis was not performed because the study was terminated prematurely due to low participants recruitment (only 2 participants enrolled), which did not allow performance of the planned correlation statistical analysis.||||||
2545203|NCT02949908|Secondary|Number of Participants Discontinued From Initial MS Treatment (Oral or Injectable) by Reason for Discontinuation|Here numbers of participants who discontinued the initial MS treatment (Oral or Injectable) are reported with the reason of discontinuation.|Baseline|Analysis population included participants who enrolled in this study and had discontinued their initial MS treatment.|||Participants|||Count of Participants
2545204|NCT02949908|Secondary|Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Month 6 and 12|The MusiQoL is a disease-specific validated 31-item multi-dimensional, self-administered questionnaire. Participants were asked to assess their level of satisfaction with the treatment. Question was answered using a 6-point Likert scale, defined as 1-Never/Not at all, 2-Rarely/A little, 3-Sometimes/Somewhat, 4-Often/A lot, 5-Always/Very much and 6-Not applicable.|Month 6, Month 12|Analysis population: participant who received study medication and had data collected for evaluation. Overall Number of Participants Analyzed = those evaluable for this outcome. Number Analyzed (n) = those evaluable at specified time point and n = 0 signifies no subject was analyzed as study terminated prematurely before Month 12 assessment.|||units on a scale|||Number
2545205|NCT02949908|Secondary|Number of Participants With Adherence to Treatment|According to the World Health Organization (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term).|Month 6 and Month 12|Analysis population: participant who received study medication and had data collected for evaluation. Overall Number of Participants Analyzed = those evaluable for this outcome. Number Analyzed (n) = those evaluable at specified time point and n = 0 signifies no subject was analyzed as study terminated prematurely before Month 12 assessment.|||Participants|||Count of Participants
2545206|NCT02949908|Secondary|Annualized Relapse Rate (ARR)|ARR defined as the number of relapses per year. A relapse is defined as the appearance of a new clinical sign or symptom attributable to MS, or clinical worsening of a previous sign or symptom that had been stable for greater than or equal to (>=) 30 days and that persisted for >=24 hours without fever.|Month 12|Data was not analyzed for this outcome as the study terminated prematurely due to low subject enrollment and no data was collected for Month 12 assessment.||||||
2545207|NCT02949908|Primary|Treatment Satisfaction Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)|TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across a wide variety of medication types and illness conditions. It consists 11 question items. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging from 1 to 7, where 1= Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied.|Month 12|Data was not analyzed for this outcome as the study terminated prematurely due to low subject enrollment and no data was collected for Month 12 assessment.||||||
2545208|NCT02949908|Primary|Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)|TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across a wide variety of medication types and illness conditions. It consists 11 question items. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging from 1 to 7, where 1= Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied.|Month 6|Analysis population included participant who received study medication and had data collected at Month 6.|||Units on a scale|||Number
2545209|NCT02949674|Primary|VAS|The Pain will be measured with this scale from 0 (No pain) -10 (Worst pain possible) according to the investigator at 24 hours after surgery.|Change in Visual Analogue Scale at 24 hours||||units on a scale (VAS)||Standard Deviation|Mean
2545210|NCT02949271|Secondary|Number of Subjects Who Were Satisfied With Procedure|"Determined using a 5-point scale where 1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied. Subjects were considered satisfied if selected very satisfied or satisfied on the patient questionnaire."|duration of labor, up to 24hrs||||Participants|||Count of Participants
2545211|NCT02949271|Secondary|Duration of Second Stage of Labor||duration of labor, up to 24hrs||||minutes||Inter-Quartile Range|Median
2545212|NCT02949271|Secondary|Number of Subjects Experiencing Hypotension Requiring Vasopressor Treatment|Number of patients who needed a vasopressor medication to treat a drop in blood pressure|duration of labor, up to 24 hrs||||Participants|||Count of Participants
2545213|NCT02949271|Secondary|Ratio of Patient Controlled Epidural Analgesia (PCEA) Successful Attempts to Unsuccessful Attempts|Ratio generated by the number of times subjects activates PCEA and receives additional anesthetic compared with times subject activates PCEA and does not receive additional anesthetic.|duration of labor, up to 24hrs||||ratio of attempts||Inter-Quartile Range|Median
2545214|NCT02949271|Secondary|Number of Patient Controlled Epidural Analgesia (PCEA) Attempts|Determined by the number of times subject activates the PCEA pump|duration of labor, up to 24hrs||||attempts||Inter-Quartile Range|Median
2545215|NCT02949271|Secondary|Total Number of Subjects Experiencing Each Mode of Delivery|Modes of delivery: spontaneous vaginal delivery (SVD), assisted vaginal delivery (AVD), and caesarean delivery (CD)|duration of labor, up to 24hrs||||Participants|||Count of Participants
2545216|NCT02949271|Secondary|Degree of Motor Blockade Measured as Lowest Recorded Modified Bromage Score|The Modified Bromage Score ranges from 1-5. 1 = complete block, 2 = almost complete block, 3 = partial block, 4 = detectable weakness of hip flexion, and 5 = no detectable weakness of hip flexion while supine.|duration of labor, up to 24hrs|Data not collected on 10 participants in the Programmed Intermittent Epidural Bolus group and in 7 in the continuous epidural infusion group.|||Participants|||Count of Participants
2545217|NCT02949271|Secondary|Maximum Reported Labor Pain Score|Measured using a verbal analog pain scale of 1-10, where 0=no pain and 10=worst possible pain.|duration of labor, up to 24hrs||||score on a scale||Inter-Quartile Range|Median
2545218|NCT02949271|Secondary|Time to First Patient Controlled Epidural Analgesia (PCEA) Bolus||duration of labor, up to 24hrs|Data not collected since it required extracting data that are not collected as part of standard practice and study team was not available sometimes when the patient delivered and this data had to be collected then before the pump was used for another patient.||||||
2545219|NCT02949271|Secondary|Volume of Local Anesthetic Required Per Hour|The total volume of local anesthetic that the patient received from the CAPP pump per hour.|duration of labor, up to 24hrs||||milliliters per hour||Inter-Quartile Range|Median
2545220|NCT02949271|Primary|Volume of Local Anesthetic Received Through Patient Controlled Epidural Analgesia (PCEA) Per Hour|The volume of local anesthetic that the patient received through activation of the patient-controlled epidural analgesia system per hour.|duration of labor, up to 24hrs||||milliliters per hour||Inter-Quartile Range|Median
2545221|NCT02949219|Other Pre-specified|Biomarker Levels|Correlated with clinical data (i.e. response, overall survival, progression free survival, adverse events). These correlations will be done using the Chi-square or Fisher?s exact test for categorical data and Kaplan-Meier methods (including the log-rank test) for the survival endpoints. Univariate Cox regression models will also be done to assess for marker effects on survival endpoints. Descriptive statistics and graphical methods will be used to summarize the data as well. All these analyses will be done overall and by MMR/microsatellite instability status.|Up to 5 years|||||||
2545222|NCT02949219|Secondary|Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events Regardless of Attribution|number of participants who experienced at least one grade 3 or higher adverse events regardless of attribution assessed by National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.03|Up to 2 years||||Participants|||Count of Participants
2545223|NCT02949219|Secondary|Overall Survival|Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|From study entry to death from any cause, assessed up to 2 years||||months||95% Confidence Interval|Median
2545224|NCT02949219|Secondary|Progression Free Survival|Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|From study entry to the first of either disease progression or death from any cause, assessed up to 2 years||||months||95% Confidence Interval|Median
2545225|NCT02949219|Primary|Overall Confirmed Response Rate|The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.|1 year (up to 18 cycles)||||percentage of participants||95% Confidence Interval|Number
2545226|NCT02949141|Primary|Diagnosis of Pneumonia|Sensitivity and specificity of ultrasound compared to chest x-ray for the diagnosis of pneumonia using Chest CT as the gold standard for diagnosis.|9 months|62|||Participants|||Count of Participants
2545227|NCT02949128|Secondary|Change From Baseline In Quality Of Life As Measured By The Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Version 4 Questionnaire At Week 26|Quality of life was evaluated in part using FACIT Fatigue Version 4. The data were summarized at baseline and at the Week 26 time point using descriptive statistics for continuous variables. The FACIT Fatigue Version 4 questionnaire at baseline and the Week 26 timepoint was scored using standard scoring algorithms. The score ranges from 0-52, with a higher score indicating less Fatigue. An increase in score indicated an improvement in quality of life.|Baseline, Week 26|Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint (Week 26).|||units on a scale||Standard Deviation|Mean
2545228|NCT02949128|Secondary|Change From Baseline In Quality Of Life As Measured By The EuroQol 5-Dimension 3-Level (EQ-5D-3L) At Week 26|The EQ-5D-3L is a participant-answered questionnaire that scores 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (scored as a 1, 2, or 3, with 3 being the worst health state), as well as health state on a visual analogue scale (0 to 100, with 100 representing the best health state). From these scores, a summary index score is derived using the time trade-off valuation set for the United States and ranges from -1 to 1, where a score above 0.94 indicates full health. An increase in score from baseline indicates improvement in quality of life.|Baseline, Week 26|Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint (Week 26).|||units on a scale||Standard Deviation|Mean
2545229|NCT02949128|Secondary|Proportion Of Participants With An Increase From Baseline In Hemoglobin ≥ 20 g/L Through Week 26|The proportion of participants with an increase from baseline in hemoglobin ≥ 20 g/L, observed at 2 separate assessments obtained at least 4 weeks (28 days) apart, and any measurement in between, was assessed through Week 26 and is presented as the proportion of responders, along with a 2-sided 95% CI. The 95% CIs are based on the asymptotic Gaussian approximation method with a continuity correction. To be considered a responder during the 26-week Initial Evaluation Period, the latest time point a participant could first meet the response criteria was 28 days before the Week 26 (Day 183) assessment (components of the response maintained for at least 28 days).|Up to Week 26|Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint (Week 26).|||proportion of participants||95% Confidence Interval|Number
2545230|NCT02949128|Secondary|Change From Baseline In Hemoglobin At Week 26|The hematologic TMA parameter of hemoglobin level was summarized at baseline and at Week 26 using descriptive statistics for continuous variables for the change from baseline. Results are reported in grams (g)/L.|Baseline, Week 26|Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint (Week 26).|||g/L||Standard Deviation|Mean
2545231|NCT02949128|Secondary|Change From Baseline In LDH At Week 26|The hematologic TMA parameter of serum LDH was summarized at baseline and at Week 26 using descriptive statistics for continuous variables for the change from baseline. Results are reported in units (U)/L.|Baseline, Week 26|Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint (Week 26).|||U/L||Standard Deviation|Mean
2545232|NCT02949128|Secondary|Change From Baseline In Platelet Count At Week 26|The hematologic TMA parameter of platelet count was summarized at baseline and at Week 26 using descriptive statistics for continuous variables for the change from baseline. Results are reported in platelets*10^9/liter (L) blood.|Baseline, Week 26|Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint (Week 26).|||platelets*10^9/L||Standard Deviation|Mean
2545233|NCT02949128|Secondary|Proportion Of Participants With Change From Baseline In Chronic Kidney Disease (CKD) Stage At Week 26|The CKD stage is presented as the change from baseline in the proportion of participants that Improved (excluding those with Stage 1 [normal renal function] at baseline as they cannot improve), Worsened (excluding those with Stage 5 at baseline as they cannot worsen), and Stayed the Same, compared to the CKD stage at baseline. Baseline was derived based on the last available eGFR before starting treatment. Stage 5 was considered the worst category, while Stage 1 was considered the best category. A 2-sided 95% CI for the proportion, based on exact confidence limits using the Clopper-Pearson method, was provided for each category. The CKD stage was classified based on the National Kidney Foundation Chronic Kidney Disease Stage.|Baseline, Week 26|Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint (Week 26).|||proportion of participants||95% Confidence Interval|Number
2545234|NCT02949128|Secondary|Observed Value And Change From Baseline In Estimated Glomerular Filtration Rate (eGFR) At Week 26|Kidney function evaluated by eGFR was summarized at baseline and the Week 26 time point using descriptive statistics for continuous variables for the observed value, as well as the change from baseline. The baseline value was defined as the average of the values from the assessments performed prior to the first study drug infusion (these could include results from Screening and the Day 1 visit). A value of 10 milliliters (mL)/minute (min)/1.73 meters squared (m^2) for eGFR was imputed for participants requiring dialysis for acute kidney injury. The observed value and change from baseline are reported in mL/min/1.73 m^2. An increase indicated improvement in kidney function.|Baseline, Week 26|Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint (Week 26).|||mL/min/1.73 m^2||Standard Deviation|Mean
2545235|NCT02949128|Secondary|Proportion Of Participants With Complete TMA Response At Week 26|The proportion of participants considered responders, along with a 2-sided 95% CI for the Week 26 time point, is reported. To be considered a responder during the 26-week Initial Evaluation Period, the latest time point a participant could first meet the response criteria was 28 days before the Week 26 (Day 183) assessment (components of the response maintained for at least 28 days).|Week 26|Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint (Week 26).|||proportion of participants||95% Confidence Interval|Number
2545236|NCT02949128|Secondary|Time To Complete TMA Response|Participants that did not have a response were censored at the date of last visit or study discontinuation at the time when the analysis was performed. The time to complete TMA Response is reported in days. The time of the event of a confirmed complete TMA response was considered the first time point at which all the criteria for complete TMA response were met.|Baseline through Week 26|Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, and met pre-specified eligibility criteria.|||days||Inter-Quartile Range|Median
2545237|NCT02949128|Primary|Proportion Of Participants With Complete Thrombotic Microangiopathy (TMA) Response|Complete TMA response during the 26-week Initial Evaluation Period is a composite outcome measure that required normalization of hematological parameters (platelet count and lactate dehydrogenase [LDH]) and improvement in kidney function (≥25% reduction in serum creatinine from baseline); for participants on dialysis, baseline was established at least 6 days after the end of dialysis. Participants had to meet these criteria for 2 separate assessments obtained at least 4 weeks (28 days) apart, and any measurement in between. To be considered a responder during the 26-week Initial Evaluation Period, the latest time point a participant could first meet the response criteria was 28 days before the Week 26 (Day 183) assessment. Formal statistical comparison analyses were not planned for this study. The proportion was based on the responders among treated participants. The 95% confidence interval (CI) was based on the asymptotic Gaussian approximation method with a continuity correction.|Week 26|Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, and met pre-specified eligibility criteria.|||proportion of participants||95% Confidence Interval|Number
2545238|NCT02949011|Secondary|Percentage of Participants With Adverse Events (AEs)||From first dose of study drug to Day 22|All participants who received at least 1 dose of study drug|||percentage of participants|||Number
2545239|NCT02949011|Secondary|Percentage of Participants With Influenza-related Complications|Defined as the percentage of patients who experience each influenza-related complication (hospitalization, death, sinusitis, otitis media, bronchitis, and radiologically-confirmed pneumonia) as an adverse event after the initiation of study treatment.|Day 1 to Day 22|Intention-to-treat population|||percentage of participants||95% Confidence Interval|Number
2545241|NCT02949011|Secondary|Time to Return to Preinfluenza Health Status|"Participants were asked to record their preinfluenza health status on a scale from 0 (worst possible health) to 10 (normal health [for someone your age and condition]), and their health status at baseline and every day after initiation of study treatment on the same scale. Return to preinfluenza health status was defined as time from the initiation of the study treatment to the first time when the health status score was equal to or higher than the preinfluenza health status score.~Time to return to preinfluenza health status was analyzed using KM methods; participants with a smaller number on the scale for health status by the last observation time point were censored at that time point."|Baseline to Day 14|Participants in the intention-to-treat infected population whose health status score at baseline was lower than the preinfluenza health status score and with available time to return to preinfluenza health status data.|||hours||95% Confidence Interval|Median
2545242|NCT02949011|Secondary|Time to Improvement of Individual Symptoms|"Participants assessed the severity of 7 influenza-associated symptoms on a 4-point scale (0 = no symptoms to 3 = severe). Time to improvement of cough, fatigue, and muscle/joint pain was defined as the time from the start of treatment to the time when each symptom was alleviated, maintained, or improved, as defined below, for at least 21.5 hours:~Preexisting symptoms that were worse at baseline must have improved at least 1 point from baseline~Preexisting symptoms not worse at baseline must have maintained baseline severity~New symptoms must have alleviated, defined as a score of 0 (None) or 1 (Mild). Time to improvement of sore throat, headache, nasal congestion, and feverish/chills was defined as the time from the start of treatment to the time when the symptom was assessed as 0 (None) or 1 (Mild) for at least 21.5 hours.~Time to improvement of symptoms was analyzed using KM methods; participants with no improvement of symptoms were censored at the last observation."|Initiation of study treatment up to Day 14|Participants in the intention-to-treat infected population; the analysis of each individual symptom includes participants with new or preexisting and worsened symptom scores of moderate (2) or severe (3) at baseline, and with available time to improvement of symptom data.|||hours||95% Confidence Interval|Median
2545243|NCT02949011|Secondary|Body Temperature at Each Time Point|Participant's self-measured axillary temperature using an electronic thermometer.|12, 24, 36, 48, 72, 96 and 120 hours after the initial dose of study treatment|Participants in the intention-to-treat infected population with available temperature data at each time point.|||°C||Standard Error|Least Squares Mean
2545244|NCT02949011|Secondary|Percentage of Participants Reporting Normal Temperature at Each Time Point|Defined as the percentage of patrticipants whose axillary body temperature dropped to less than 37ºC after the initiation of the study treatment.|12, 24, 36, 48, 72, 96, 120, 144, 168, 192, and 216 hours after the initial dose of study treatment|Participants in the intention-to-treat infected population whose body temperature at baseline was more than 37°C and with available body temperature data at each time point.|||percentage of participants||95% Confidence Interval|Number
2545245|NCT02949011|Secondary|Time to Resolution of Fever|Time to resolution of fever was defined as the time between the initiation of the study treatment and the resolution of fever. The resolution of fever was defined as the time when the participant's self-measured axillary temperature became less than 37ºC and was maintained at less than 37ºC for at least 12 hours. Time to resolution of fever was analyzed using KM methods; participants who did not experience resolution of fever by the last observation time point were censored at that time point.|Initiation of study treatment up to Day 14|Participants in the intention-to-treat infected population whose body temperature at baseline was more than 37°C and time to resolution of fever was not missing|||hours||95% Confidence Interval|Median
2545246|NCT02949011|Secondary|Time to Improvement of the Three Respiratory Symptoms|"Participants assessed the severity of 7 influenza-associated symptoms on a 4-point scale (from 0 = no symptoms to 3 = severe symptoms). Time to improvement of the 3 respiratory symptoms was defined as the time from the start of study treatment to the time when all 3 respiratory symptoms (cough, sore throat, and nasal congestion) were alleviated, maintained, or improved, as defined below, for a duration of at least 21.5 hours:~Preexisting symptoms (cough, fatigue, or muscle/joint pain that existed prior to influenza) that were worse at baseline must have improved at least 1 point from baseline~Preexisting symptoms not worse at baseline must have maintained baseline severity~New symptoms at baseline must have alleviated, defined as a symptom score of none (0) or mild (1).~Time to improvement of the 3 respiratory symptoms was analyzed using KM methods; participants who did not experience improvement of symptoms were censored at the last observation time point."|Initiation of study treatment up to Day 14|Participants in the intention-to-treat infected population with available time to improvement of the 3 respiratory symptoms data.|||hours||95% Confidence Interval|Median
2545247|NCT02949011|Secondary|Time to Improvement of the Four Systemic Symptoms|"Participants assessed the severity of 7 influenza-associated symptoms on a 4-point scale (from 0 = no symptoms to 3 = severe symptoms). Time to improvement of the 4 systemic symptoms was defined as the time between the initiation of study treatment to the time when all 4 systemic symptoms (headache, feverishness or chills, muscle or joint pain, and fatigue) were alleviated, maintained, or improved, as defined below, for a duration of at least 21.5 hours:~Preexisting symptoms (cough, fatigue, or muscle/joint pain that existed prior to influenza) that were worse at baseline must have improved at least 1 point from baseline~Preexisting symptoms not worse at baseline must have maintained baseline severity~New symptoms at baseline must have alleviated, defined as a symptom score of none (0) or mild (1).~Time to improvement of the 4 systemic symptoms was analyzed using KM methods; participants who did not experience improvement of symptoms were censored at the last observation."|Initiation of study treatment up to Day 14|Participants in the intention-to-treat infected population with available time to improvement of the 4 systemic symptoms data.|||hours||95% Confidence Interval|Median
2545248|NCT02949011|Secondary|Time to Alleviation of Symptoms|"Participants assessed the severity of seven influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (with 0 indicating no symptoms, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms).~Time to alleviation of symptoms was defined as the time from the start of the study treatment to the time when all seven influenza-related symptoms were assessed by the participant as absent (0) or mild (1) for at least 21.5 hours.~Time to alleviation of symptoms was analyzed using Kaplan-Meier (KM) methods; participants who did not experience alleviation of symptoms were censored at the last observation time point."|Initiation of study treatment up to Day 14|Participants in the intention-to-treat infected population with available time to alleviation of symptoms data.|||hours||95% Confidence Interval|Median
2545249|NCT02949011|Secondary|Percentage of Participants Whose Symptoms Were Improved at Each Time Point|"Participants assessed the severity of 7 influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) on a 4-point scale (0 = no symptoms, 1= mild, 2 = moderate, and 3 = severe).~Improvement of symptoms was defined as all influenza symptoms alleviated, maintained, or improved, as defined below, for a duration of at least 21.5 hours:~Preexisting symptoms (cough, fatigue, or muscle/joint pain that existed prior to influenza) judged to be worse at baseline must have improved at least 1 point from baseline severity~Preexisting symptoms judged not to be worse at baseline must have maintained baseline severity~New symptoms at baseline must have alleviated, defined as a symptom score of none (0) or mild (1)."|12, 24, 36, 48, 72, 96, 120, 144, 168, 192, and 216 hours after the initial dose of study treatment|Participants in the intention-to-treat infected population with available symptoms data at each time point.|||percentage of participants||95% Confidence Interval|Number
2545250|NCT02949011|Secondary|Time to Cessation of Viral Shedding Determined by Virus RNA|"Time to cessation of viral shedding by RT-PCR was defined as the time between the initiation of the study treatment and first time when the virus RNA was below the limit of detection measured by RT-PCR.~Time to cessation of viral shedding by RT-PCR was analyzed using the KM method; participants whose virus RNA had not reached cessation by the last observation time point were treated as censored at that time point."|Day 1 to Day 9|Participants in the intention-to-treat infected population with positive influenza virus RNA determined by RT-PCR on Day 1 whose time to cessation of viral shedding by RT-PCR.|||hours||95% Confidence Interval|Median
2545251|NCT02949011|Secondary|Time to Cessation of Viral Shedding Determined by Virus Titer|Time to cessation of viral shedding by virus titer was defined as the time between the initiation of the study treatment and first time when the virus titer was below the limit of detection (0.7 log₁₀[TCID₅₀/mL]). The median and 95% confidence interval (CI) for time to cessation of viral shedding determined by virus titer was analyzed using the Kaplan-Meier (KM) method; participants whose virus titer had not reached cessation by the last observation time point were treated as censored at that time point.|Day 1 to Day 9|Participants in the intention-to-treat infected population with a positive virus titer on Day 1 whose time to cessation of viral shedding by virus titer was not missing.|||hours||95% Confidence Interval|Median
2545252|NCT02949011|Secondary|Area Under the Curve (AUC) Adjusted by Baseline in Viral RNA|This endpoint was defined as AUC of change from baseline in the amount of virus RNA (RT-PCR) from Day 1 to Day 9. The AUC was calculated using the trapezoidal method.|Day 1 to Day 9|Participants in the intention-to-treat infected population with a positive virus RNA determined by RT-PCR at baseline and available sample on Day 9.|||log₁₀ virus particles/mL*hours||Standard Deviation|Mean
2545253|NCT02949011|Secondary|Area Under the Curve (AUC) Adjusted by Baseline in Influenza Virus Titer|This endpoint was defined as AUC of change from Baseline in virus titer from Day 1 to Day 9. AUC was calculated using the trapezoidal method.|Day 1 to Day 9|Participants in the intention-to-treat infected population with a positive virus titer on Day 1 and available sample on Day 9.|||log₁₀[TCID₅₀/mL]*hours||Standard Deviation|Mean
2545254|NCT02949011|Secondary|Change From Baseline in Virus RNA (RT-PCR) at Each Time Point|Nasopharyngeal swabs (or throat swabs, if nasopharyngeal swabbing was not feasible) were obtained for viral quantitation. Virus RNA was measured by reverse transcription polymerase chain reaction (RT-PCR).|Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9|Participants in the intention-to-treat infected population with positive RT-PCR on Day 1 and with available virus RNA data at each time point.|||log₁₀ virus particles/mL||Standard Deviation|Mean
2545255|NCT02949011|Secondary|Change From Baseline in Virus Titer at Each Time Point|"Virus titer was quantified from nasopharyngeal swabs (or throat swabs if nasopharyngeal swabbing was not feasible) by tissue culture methods.~If virus titer was less than the lower limit of quantification, the virus titer was imputed 0.7 (TCID₅₀/mL)."|Day 1 pretreatment (Baseline) and Days 2, 3, 4 (optional), 5, 6 (optional), and 9|Participants in the intention-to-treat infected population with positive influenza virus titer on Day 1 and with available virus titer data at each time point.|||log₁₀[TCID₅₀/mL]||Standard Deviation|Mean
2545256|NCT02949011|Secondary|Percentage of Participants With Positive Influenza Virus by RT-PCR at Each Time Point|Influenza virus ribonucleic acid (RNA) was quantified from nasopharyngeal swabs (or throat swabs, if nasopharyngeal swabbing was not feasible). The percentage of participants with detectable virus RNA (2.05 for flu A and 2.83 for flu B log₁₀ virus particles/mL) measured by reverse transcription polymerase chain reaction (RT-PCR) among those assessed on Days 2, 3, 4, 5, 6 and 9.|Days 2, 3, 4 (optional), 5, 6 (optional), and 9.|Participants in the intention-to-treat infected population with positive influenza virus RNA determined by RT-PCR on Day 1 and with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
2545257|NCT02949011|Secondary|Percentage of Participants With Positive Influenza Virus Titer at Each Time Point|Virus titer was quantified from nasopharyngeal swabs (or throat swabs if nasopharyngeal swabbing was not feasible) using tissue culture methods. Positive influenza virus titer was defined as virus titer not less than the lower limit of quantification (0.7 log₁₀ of the 50% tissue culture infective dose (TCID₅₀/mL) among those assessed for virus titer on Days 2, 3, 4, 5, 6, and 9.|Days 2, 3, 4 (optional), 5, 6 (optional), and 9|Participants in the intention-to-treat infected population with a positive influenza virus titer on Day 1 and with available virus titer data at each time point.|||percentage of participants||95% Confidence Interval|Number
2545258|NCT02949011|Primary|Time to Improvement of Influenza Symptoms|"Participants assessed the severity of 7 influenza-associated symptoms (cough, sore throat, headache, nasal congestion, feverishness/chills, muscle/joint pain, and fatigue) on a 4-point scale (0 = no symptoms, 1= mild, 2 = moderate, and 3 = severe). Time to improvement of symptoms was defined as the time from the start of treatment to the time when all influenza symptoms were alleviated, maintained, or improved, as defined below, for a duration of at least 21.5 hours:~Preexisting symptoms (cough, fatigue, or muscle/joint pain that existed prior to influenza) that were worse at baseline must have improved at least 1 point from baseline~Preexisting symptoms not worse at baseline must have maintained baseline severity~New symptoms must have alleviated, defined as a symptom score of none (0) or mild (1).~Time to improvement of symptoms was analyzed using Kaplan-Meier (KM) methods; participants who did not experience improvement of symptom s were censored at the last observation."|From Day 1 pretreatment up to Day 14|Participants in the intention-to-treat infected population with available time to improvement of symptoms data.|||hours||95% Confidence Interval|Median
2545262|NCT02948582|Secondary|Percentage of Subjects With Treatment Emergent AEs|AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment|Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69)|all subjects who received at least one dose of study drug were included in the safety analysis|||percentage of participants|||Number
2545263|NCT02948582|Secondary|Number of Subjects With Clinically Significant ECG Parameters Reported During the Study|ECGs were recorded at screening and at each study treatment visit pre-dose (within 30 minutes prior to dose); post-dose at 30 minutes and 1, 2, 4, 8, 12 and 24 hours; and then at the post study assessment.|0 to 24h|all subjects who received at least one dose of study drug were included in the safety analysis|||Participants|||Count of Participants
2545264|NCT02948582|Secondary|Number of Clinically Significant Abnormal Laboratory Results Reported During the Study|Clinical safety lab parameters were collected at screening and at the post study assessment. Any laboratory values that were out of range of normal reference values were evaluated by the Investigators.|Day -14, Day 69|all subjects who received at least one dose of study drug were included in the safety analysis|||number of events|||Number
2545265|NCT02948582|Secondary|Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study|Vital signs were measured at screening and at each Treatment Visit pre-dose (within 30 minutes prior to dose); post-dose at 30 minutes and 1, 2, 4, 8, 12 and 24 hours; and then at the post study assessment.|0-24 h|all subjects who received at least one does of study drug were included in the safety analysis|||Participants|||Count of Participants
2545266|NCT02948582|Secondary|Number of Subjects Who Died, Number of Subjects With Treatment Emergent SAEs, Number of Subjects Who Discontinued Due to AE|AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment|Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69)|all subjects who received at least one dose of study drug were included in the safety analysis|||participants|||Number
2545267|NCT02948582|Secondary|AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr|0 to 12 hour|All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis.|||pg.h/ml||Geometric Coefficient of Variation|Geometric Mean
2545268|NCT02948582|Secondary|AUC0-t; Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Drug Concentration.|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr|0 to 12 hour|All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis.|||pg.h/ml||Geometric Coefficient of Variation|Geometric Mean
2545269|NCT02948582|Secondary|t1/2; Plasma Half-life|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr|0 to 12 hour|All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis.|||hours||Geometric Coefficient of Variation|Geometric Mean
2545270|NCT02948582|Secondary|Tmax; Time to Maximum Observed Plasma Concentration|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr|0 to 12 hours|All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis.|||hours||Full Range|Median
2545271|NCT02948582|Secondary|Cmax; Maximum Observed Plasma Concentration|Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr|0 to 12 hour|All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2545272|NCT02948582|Primary|Peak FEV1 (Change From Baseline and Percent Change)|spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. . The peak FEV1 was defined as the highest post-dose FEV1 value within 4 hrs after the dose. Percent change from baseline was calculated as 100 times the difference of peak FEV1 minus baseline FEV1 divided by baseline FEV1.|0-4h post dose|all subjects who received at least one dose of study medication and have at least one post baseline efficacy measurement were included in the efficacy population|||liters||Standard Deviation|Mean
2545273|NCT02948582|Primary|Standardized FEV1 AUC0-24 Area Under the FEV1 Curve From 0 to 24 Hours Post-dose (Actual and Change Baseline)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. . The standardized actual FEV1 AUC(0-24) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(0-24) was also calculated similarly, using the change from pre-dose FEV1.|0 to 24h|all subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent to treat analysis|||liters||Standard Deviation|Mean
2545274|NCT02948582|Primary|Standardized FEV1AUC12-24 Area Under the FEV1 Curve From 12 to 24 Hours Post- Dose (Actual and Change From Baseline).|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. The standardized actual FEV1 AUC(12-24) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(12-24) was also calculated similarly, using the change from pre-dose FEV1.|12-24h post dose|All subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent to treat analysis|||liters||Standard Deviation|Mean
2545293|NCT02947022|Secondary|Change in American Chronic Pain Association (ACPA) Quality of Life (QOL) Score From Baseline to Month 1|"The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents Non-functioning and 10 represents Normal Quality of Life."|Baseline, Month 1 (day 7)|Data were not analyzed because this study was stopped prematurely.||||||
2545275|NCT02948582|Primary|Standardized FEV1AUC0-12 Area Under the FEV1 Curve From 0 to 12 Hours Post-dose ( Actual and Change From Baseline).|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.. The standardized actual FEV1 AUC(0-12) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(0-12) was also calculated similarly, using the change from pre-dose FEV1.|0-12h post dose|All subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent to treat analysis|||liters||Standard Deviation|Mean
2545276|NCT02948582|Primary|Trough FEV1 (Change From Baseline)|"Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.~Trough FEV1 was defined as the mean of FEV1 values obtained at 23 hours 30 minutes and 24 hours post-dose of each Treatment Visit."|24hr post dose|All subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent-to-treat analysis.|||liters||Standard Deviation|Mean
2545277|NCT02948257|Secondary|Minor Access Site Closure-related Complications|Patient incident rate of combined minor access site closure-related complications through 30 days|Through 30 +/- 7 days||||Participants|||Count of Participants
2545278|NCT02948257|Secondary|Procedure Success|Procedure Success is defined as attainment of Device Success and freedom from major access site closure-related complications through 30 days.|Through 30 +/- 7 days||||Participants|||Count of Participants
2545279|NCT02948257|Secondary|Device Success|Device Success is defined as the ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Cardiva VASCADE VCS alone or with adjunctive compression.|Procedural, usually within 15 minutes of enrollment||||Participants|||Count of Participants
2545280|NCT02948257|Secondary|Time to Discharge (TTD)|Time to Discharge (TTD) is defined as elapsed time between VASCADE device removal and discharge from the facility.|Through hospital discharge, usually within 24 hours||||hours||Standard Deviation|Mean
2545281|NCT02948257|Secondary|Time to Ambulation (TTA)|Time to Ambulation (TTA) is defined as elapsed time between VASCADE device removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site.|Prior to discharge, usually within 24 hours||||hours||Standard Deviation|Mean
2545282|NCT02948257|Primary|Major Access Site Closure-related Complications|Patient incident rate of combined major access site closure-related complications through 30 days|Through 30 days +/- 7 days||||Participants|||Count of Participants
2545283|NCT02948257|Primary|Time to Hemostasis (TTH)|Time to Hemostasis (TTH) is defined as elapsed time between VASCADE device removal and first observed and confirmed arterial hemostasis.|Procedural, usually within 15 minutes of enrollment||||minutes||Standard Deviation|Mean
2545284|NCT02947997|Primary|Number of Participants For Whom Good Quality Images Were Recorded After Swallowing The OFDI Capsule|An investigator to assess the quality of the recorded images obtained with each exam after imaging has been completed|Approximate 20 minute visit (5 min image acquisition)||||Participants|||Count of Participants
2545285|NCT02947984|Secondary|Local Failure Rate|The number of participants with local failure. Local failure is defined as radiologic progression seen on follow-up scans showing tumor margin(s) extending in any direction at least five mm beyond that seen on baseline scans.|15 Years|Failure rates are shown by dose group in the overall study population and by treatment indication subgroups.|||participants|||Number
2545286|NCT02947984|Secondary|Late Toxicities|The number of participants that experienced the specified late toxicities (any grade) as assessed by Radiation Therapy Oncology Group Late Effects Scale.|5 Years||||participants|||Number
2545287|NCT02947984|Secondary|Acute Toxicities|The number of participants that experienced the specified acute toxicities (any grade) as assessed by Radiation Therapy Oncology Acute Morbidity Scoring Criteria. Acute toxicities were assessed from the start of treatment through day 90 of treatment.|90 Days||||participants|||Number
2545288|NCT02947984|Primary|Progression Free Survival|The number of participants surviving at the given time point. Progression free survival (PFS) is measured from the starting date of radiation therapy and analyzed by intention to treat. PFS is measured until the earlier, date of death or development of radiologic progression, and is otherwise censored at the last follow-up for progression-free patients still alive.|5, 10, 15 years|Progression free survival in the entire cohort and by radiation indication sub-groups|||percentage of participants surviving||95% Confidence Interval|Number
2545289|NCT02947022|Secondary|Change in ACPA QOL Score at Month 12|"The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents Non-functioning and 10 represents Normal Quality of Life."|Baseline, Month 12|Data were not analyzed because this study was stopped prematurely.||||||
2545290|NCT02947022|Secondary|Change in ACPA QOL Score at Month 6|"The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents Non-functioning and 10 represents Normal Quality of Life."|Baseline, Month 6|Data were not analyzed because this study was stopped prematurely.||||||
2545291|NCT02947022|Secondary|Change in ACPA QOL Score at Month 3|"The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents Non-functioning and 10 represents Normal Quality of Life."|Baseline, Month 3 (day 7)|Data were not analyzed because this study was stopped prematurely.||||||
2545292|NCT02947022|Secondary|Change in ACPA QOL Score From Baseline to Month 2|"The ACPA QOL is a self-administered questionnaire measuring functionality for people with pain which looks at the ability to function, rather than pain alone and is intended to measure activity levels. The ACPA QOL consists of 10 possibilities ranging from 0 to 10 where 0 represents Non-functioning and 10 represents Normal Quality of Life."|Baseline, Month 2 (day 7)|Data were not analyzed because this study was stopped prematurely.||||||
2547687|NCT02902770|Primary|Pain Score at 30 Minutes|The trial will compare the patient's pain score on a 11 point Likert scale, ranging from 0 to 10 with 0 being no pain, 5 moderate pain and 10 very severe pain, at 30 minutes|30 minutes||||score on a scale||Standard Deviation|Mean
2545294|NCT02947022|Secondary|Change From Baseline to Month 12 in the Pain Score|"Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates no pain, 4 through 6 reflect moderate pain, and 10 reflects worst possible pain."|Baseline, Month 12|Data were not analyzed because this study was stopped prematurely.||||||
2545295|NCT02947022|Secondary|Change From Baseline to Month 6 in the Pain Score|"Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates no pain, 4 through 6 reflect moderate pain, and 10 reflects worst possible pain."|Baseline, Month 6|Data were not analyzed because this study was stopped prematurely.||||||
2545296|NCT02947022|Secondary|Change From Baseline to Month 3 in the Pain Score|"Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates no pain, 4 through 6 reflect moderate pain, and 10 reflects worst possible pain."|Baseline, Month 3 (Day 7)|Data were not analyzed because this study was stopped prematurely.||||||
2545297|NCT02947022|Secondary|Change From Baseline to Month 2 in the Pain Score|"Patient self-reported pain scores assessed using a VAS ranging from 0 to 10 where 0 indicates no pain, 4 through 6 reflect moderate pain, and 10 reflects worst possible pain."|Baseline, Month 2 (Day 7)|Data were not analyzed because this study was stopped prematurely.||||||
2545298|NCT02947022|Secondary|Change From Baseline to Month 1 in the Pain Score|"Patient self-reported pain scores assessed using a Visual Analog Scale (VAS) ranging from 0 to 10 where 0 indicates no pain, 4 through 6 reflect moderate pain, and 10 reflects worst possible pain."|Baseline, Month 1 (Day 7)|Data were not analyzed because this study was stopped prematurely.||||||
2545299|NCT02947022|Secondary|Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.||Baseline, Month 3|Data were not analyzed because this study was stopped prematurely.||||||
2545300|NCT02947022|Secondary|Change From Baseline to Month 3 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.||Baseline, Month 3|Data were not analyzed because this study was stopped prematurely.||||||
2545301|NCT02947022|Secondary|Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.||Baseline, Month 2|Data were not analyzed because this study was stopped prematurely.||||||
2545302|NCT02947022|Secondary|Change From Baseline to Month 2 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.||Baseline, Month 2|Data were not analyzed because this study was stopped prematurely.||||||
2545303|NCT02947022|Primary|Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Zinc DTPA Administration.||Baseline, Month 1|Data were not analyzed because this study was stopped prematurely.||||||
2545304|NCT02947022|Primary|Change From Baseline to Month 1 in Gd Level From 24-hour Urine Samples Following Calcium DTPA Administration.||Baseline, Month 1|Data were not analyzed because this study was stopped prematurely.||||||
2545305|NCT02946580|Secondary|Number of Participants That Experienced Diarrhea||through study completion, an average of 6 days||||Participants|||Count of Participants
2545306|NCT02946580|Secondary|Patient's Satisfaction With Their Bowels at Discharge Using a 5-point Likert Scale.|"Patients completed a bowel satisfaction questionnaire on day of discharge. 5-point Likert scale, Very dissatisfied to Very satisfied. Higher scores mean a better outcome."|upon discharge from hospital, an average of 5 days||||score on a scale||Standard Deviation|Mean
2545307|NCT02946580|Secondary|Patient's Satisfaction With Their Bowels by Use of the Bowel Function Index|BFI normal reference range is 0-28.8 (on a scale of 100 for all 3 items summed and divided by 3). Higher scores mean a worse outcome.|through study completion, an average of 6 days||||score on a scale||Standard Deviation|Mean
2545308|NCT02946580|Secondary|Length of Stay||through study completion, an average of 6 days||||hours||Standard Deviation|Mean
2545309|NCT02946580|Secondary|Time to Rescue Laxative Medication Use During Hospitalization|"The use of a rescue laxative medication is defined as the administration of an additional bowel medication due to a decision by the clinical treatment team that the subject suffered from constipation and required a rescue bowel medication. Of note, this medication did not include the study drug, placebo, or the standing laxative orders used in all patient (docusate and sennosides). By definition, a rescue medication could only be given before a subject's first bowel movement or discharge"|upon discharge from hospital, an average of 5 days|Patients who received rescue laxative medication while hospitalized.|||hours||Full Range|Mean
2545310|NCT02946580|Primary|Time to First Post-operative Spontaneous Bowel Movement|The primary endpoint of the study was time to first post-operative bowel movement, as defined by the first spontaneous bowel movement reported by nursing staff after transfer from the surgical suite to the inpatient floor. A bowel movement was defined as the spontaneous passage of one tablespoon or more of liquid or solid stool (excluding flatus), which could be measured and verified by nursing staff. Time was measured in hours post-operatively with the starting time point marked at the end of the surgical procedure.|through study completion, an average of 6 days||||hours||Inter-Quartile Range|Mean
2545311|NCT02946515|Primary|Simulation Total Role Play Score|Change from baseline in simulation total role-play score with a trained actor to evaluate the simulation's efficacy. The role-play scale measured the clinical skills of the participants assessed using standardized patients (SPs), blind to study condition, who acted as parents of a child with overweight during a well-child visit. Immediately following each 15-minute interaction with a study participant, the SP completed a checklist that assessed whether the participant 1) completed the skill correctly, 2) completed the skill incorrectly; or 3) did not complete the skill. Participants received a score of 1 if they completed the skill correctly in both Case A and Case B. The minimum score on the scale is 0 and the maximum score is 60, with higher scores indicating a better outcome.|3 months after baseline||||score on a scale||Standard Deviation|Mean
2545312|NCT02946489|Secondary|Confidence in Abstaining From Cannabis|Change in confidence in abstaining from cannabis as measured by the DCQ (Drug-Taking Confidence Questionnaire). DCQ is a scale from 0 to 100, with higher values indicating greater confidence in one's ability to abstain from cannabis.|Change between pre-infusion and end of 6 week study||||units on a scale||Standard Deviation|Mean
2545313|NCT02946489|Primary|Percentage of Participants With Cannabis Abstinence or Significant Reduction in Cannabis Use|Percentage of participants with cannabis abstinence or significant reduction in cannabis use by end of study. Significant reduction in cannabis use was defined as: At least 50% reduction in cannabis use between pre-infusion and end of 6 week study.|At Week 6 (End of study)||||Participants|||Count of Participants
2545314|NCT02946463|Secondary|Percentage Of Participants With Stabilized Hemoglobin Levels|Stabilized hemoglobin was defined as avoidance of a ≥2 g/dL decrease in hemoglobin level from baseline in the absence of transfusion through Day 183.|Baseline through Day 183|Full Analysis Set: All participants who received at least 1 dose of study drug (ravulizumab or eculizumab) and had at least 1 efficacy assessment after the first infusion of study drug.|||percentage of participants||95% Confidence Interval|Number
2545315|NCT02946463|Secondary|Change From Baseline In Quality Of Life As Assessed By The Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue|FACIT-Fatigue score ranges from 0 to 52, with a higher score indicating less fatigue. Baseline is defined as the last non-missing value prior to first dose of study drug. Estimates are based on MMRM that includes treatment group, the observed stratification randomization indicators (history of transfusion and LDH) and baseline FACIT-Fatigue level, study visit, and study visit by treatment group interaction. An unstructured covariance structure was used.|Baseline, Day 183|Full Analysis Set: All participants who received at least 1 dose of study drug (ravulizumab or eculizumab) and had at least 1 efficacy assessment after the first infusion of study drug.|||units on a scale||95% Confidence Interval|Least Squares Mean
2545316|NCT02946463|Secondary|Percent Change From Baseline In Lactate Dehydrogenase (LDH) Levels|Baseline is defined as the average of all available assessments of LDH levels prior to first study drug dose. Estimates are based on Mixed Model for Repeated Measures (MMRM) that includes treatment group, history of transfusion (as a categorical variable based on the stratification factor levels) and baseline LDH level (as a continuous variable), study visit and study visit by treatment group interaction. An unstructured covariance structure was used.|Baseline, Day 183|Full Analysis Set: All participants who received at least 1 dose of study drug (ravulizumab or eculizumab) and had at least 1 efficacy assessment after the first infusion of study drug.|||percent change||95% Confidence Interval|Least Squares Mean
2545317|NCT02946463|Secondary|Percentage Of Participants With Breakthrough Hemolysis (BTH)|Breakthrough hemolysis was defined as at least 1 new or worsening symptom or sign of intravascular hemolysis (fatigue, hemoglobinuria, abdominal pain, shortness of breath [dyspnea], anemia [hemoglobin <10 gram/deciliter (g/dL)], major adverse vascular event [MAVE, including thrombosis], dysphagia, or erectile dysfunction) in the presence of elevated LDH ≥2 × ULN, after prior LDH reduction to <1.5 × ULN on therapy.|Baseline through Day 183|Full Analysis Set: All participants who received at least 1 dose of study drug (ravulizumab or eculizumab) and had at least 1 efficacy assessment after the first infusion of study drug.|||percentage of participants||95% Confidence Interval|Number
2545318|NCT02946463|Primary|Percentage Of Participants Who Achieved Transfusion Avoidance (TA)|Transfusion avoidance was defined as the percentage of participants who remained transfusion free and did not require a transfusion per protocol-specified guidelines through Day 183.|Baseline through Day 183|Full Analysis Set: All participants who received at least 1 dose of study drug (ravulizumab or eculizumab) and had at least 1 efficacy assessment after the first infusion of study drug.|||percentage of participants||95% Confidence Interval|Number
2545319|NCT02946463|Primary|Proportion Of Participants With Normalization Of Lactate Dehydrogenase (LDH) Levels|LDH is an indicator of intravascular hemolysis that occurs in patients with paroxysmal nocturnal hemoglobinuria (PNH). A decrease in LDH from above the upper limit of normal (ULN) to below the ULN indicates reduction (improvement) in hemolysis. Normalization of LDH levels (LDH-N) was LDH levels less than or equal to 1 x ULN, from Day 29 through Day 183. The ULN for LDH is 246 U/L.|Day 29 through Day 183|Full Analysis Set: All participants who received at least 1 dose of study drug (ravulizumab or eculizumab) and had at least 1 efficacy assessment after the first infusion of study drug.|||proportion of participants||95% Confidence Interval|Number
2545320|NCT02946385|Secondary|Number of Subjects With Any Serious AE (SAE), Medically Attended AEs (MAAEs), AEs Leading to Premature Withdrawal|Serious adverse events (SAEs), medically attended adverse events and AEs leading to withdrawal are reported. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in one or more of the following: -Death, -Is life-threatening,-Required or prolonged hospitalization, -Persistent or significant disability/incapacity, -Congenital anomaly/or birth defect, -An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.|During the entire study period (up to Day 181 for follow-on subjects and up to Day 241 for naive subjects)|Analysis was done on subjects in Unsolicited Safety Set: all screened subjects who provided informed consent, demographic and/or other baseline screening measurements, regardless of subject’s randomization and vaccination status in the trial, received subject ID and study vaccination, and provided post-vaccination unsolicited adverse events data|||Participants|||Count of Participants
2545321|NCT02946385|Secondary|Number of Subjects With Unsolicited AEs, 30 Days After Any Vaccination|An unsolicited adverse event is an adverse event that was not solicited and that was spontaneously communicated by a subject and/or parent/legal guardian who has signed the informed consent. Number of subjects reporting any unsolicited AE within 30 minutes after each vaccination.|From Day 1 to Day 31 for all subjects and Day 61 to Day 91 for naive subjects|Analysis was done on subjects in Unsolicited Safety Set: all screened subjects who provided informed consent, demographic and/or other baseline screening measurements, regardless of subject’s randomization and vaccination status in the trial, received subject ID and study vaccination, and provided post-vaccination unsolicited adverse events data|||Participants|||Count of Participants
2545322|NCT02946385|Secondary|Number of Subjects With Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7.|Assessed solicited symptoms were pain, erythema and induration. Assessed solicited systemic symptoms were Fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills, and fever (body temperature ≥38.0°C).|At Day 1 (6 hours) to Day 7 after vaccination at Day 1 (for all subjects) and Day 61 to Day 67 (for naive subjects only)|Analysis was done on subjects in Solicited Safety Set: all screened subjects who provided informed consent, demographic and/or other baseline screening measurements, regardless of the subject’s randomization and vaccination status in the trial, received subject ID and study vaccination, and provided post-vaccination solicited adverse events data|||Participants|||Count of Participants
2547165|NCT02911909|Secondary|Visual Analog Scale (VAS)|Compare the mean VAS scores (0 no pain - 10 worse pain ever) between the Delfi and the control group|12 months|No patient in the Delfi group complete the 12 months evaluation / No data obtained in the Delfi group|||score on a scale||Standard Deviation|Mean
2545323|NCT02946385|Secondary|Number of Subjects With Any Unsolicited AEs Within 30 Minutes After Vaccination|An unsolicited adverse event is an adverse event that was not solicited and that was spontaneously communicated by a subject and/or parent/legal guardian who has signed the informed consent. Number of subjects reporting any unsolicited AE within 30 minutes after each vaccination. Note: unsolicited AEs within 30 minutes were not collected|Within 30 minutes after vaccination at Day 1 (for all subjects) and also Day 61 (for naive subjects only)|Analysis was to be done on subjects in Unsolicited Safety Set but was not performed as AEs within 30 minutes after vaccination were not collected.||||||
2545324|NCT02946385|Secondary|Number of Subjects With Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination|Assessed solicited symptoms were Pain, erythema and induration. Assessed solicited systemic symptoms were Fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills, and fever (body temperature ≥38.0°C).|within 30 minutes after vaccination at Day 1 (for all subjects) and also Day 61 (for naive subjects only)|Analysis was done on subjects in Solicited Safety Set: all screened subjects who provided informed consent, demographic and/or other baseline screening measurements, regardless of the subject’s randomization and vaccination status in the trial, received subject ID and study vaccination, and provided post-vaccination solicited adverse events data|||Participants|||Count of Participants
2545325|NCT02946385|Secondary|hSBA GMTs Against Each of Four Serogroup B Test Strains At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups|The immunogenicity of rMenB+OMV vaccine, was measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.|At Day 1, at Day 6 and 31(after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination) in B_0_2 Group, and at Day 1, at Day 66 and 91(i.e. day 6 and 1 month after second dose of rMenB+OMV) in Naive_B Group|All subjects in FAS immunogenicity(Days 6 and 31, after booster[follow-on]/D66 and 91 after dose 2[naive]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.|||Titers||95% Confidence Interval|Geometric Mean
2545326|NCT02946385|Secondary|Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in rMenB+OMV Groups|The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA.|At Day 6 and 31(after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination) in B_0_2 Group, and at Day 66 and 91(i.e. day 6 and 1 month after second dose of rMenB+OMV) in Naive_B Group|All subjects in FAS immunogenicity(Days 6 and 31, after booster[follow-on]/D66 and 91 after dose 2[naive]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.|||Percentage of subjects||95% Confidence Interval|Number
2545327|NCT02946385|Secondary|Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains at 24 Months At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in rMenB+OMV Groups|The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with HT-hSBA titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.|At Day 1, at Day 6 and 31(after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination) in B_0_2 Group, and at Day 1, at Day 66 and 91(i.e. day 6 and 1 month after second dose of rMenB+OMV) in Naive_B Group|All subjects in FAS immunogenicity(Days 6 and 31, after booster[follow-on]/D66 and 91 after dose 2[naive]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.|||Percentage of subjects||95% Confidence Interval|Number
2545328|NCT02946385|Secondary|hSBA GMTs Against Each of Four Serogroup B Test Strains, at Day 31 After rMenB+OMV Vaccination in V102_15E1|The immunogenicity of rMenB+OMV vaccine, was measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.|Day 31: One month after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination in B_0_2 Group and after first dose of rMenB+OMV in Naive_B Group|All subjects in the FAS immunogenicity (Day 31, after booster dose[follow-on]/first dose[naive]) who were randomized (if naive), received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain or serogroups A, C, W or Y at Day 31 in the extension study.|||Titers||95% Confidence Interval|Geometric Mean
2545329|NCT02946385|Secondary|Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains at Day 31 After rMenB+OMV Vaccination in V102_15E1|The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA.|Day 31: One month after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMV vaccination in B_0_2 Group and after first dose of rMenB+OMV in Naive_B Group|All subjects in the FAS immunogenicity (Day 31, after booster dose[follow-on]/first dose[naive]) who were randomized (if naive), received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain at Day 31 in the extension study.|||Percentage of subjects||95% Confidence Interval|Number
2545330|NCT02946385|Secondary|Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains at Day 31 After rMenB+OMV Vaccination in V102_15E1|The immunogenicity of rMenB+OMV vaccine, was measured as the percentages of subjects with HT-hSBA titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.|Day 31: One month after a booster dose of rMenB+OMV given at 24 months after last rMenB+OMVl vaccination in B_0_2 Group and after first dose of rMenB+OMV in Naive_B Group|All subjects in the FAS immunogenicity (Day 31, after booster dose[follow-on]/first dose[naive]) who were randomized (if naive), received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain at Day 31 in the extension study.|||Percentage of subjects||95% Confidence Interval|Number
2545331|NCT02946385|Secondary|hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 1, 6, 31 in Follow-on Subjects in V102_15 and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups|The immunogenicity of MenABCWY vaccine, was measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y . The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.|At Day 1, Day 6 and 31(after booster dose of MenABCWY given at 24 months after last MenABCWY vaccination) in ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 groups and at Day 1, Day 66 and 91(i.e. day 6 and 1 month after dose 2 of MenABCWY) in Naive_ABCWY Group|All subjects in FAS immunogenicity(Days 6 and 31, after booster[follow-on]/D66 and 91 after dose 2[naive]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.|||Titers||95% Confidence Interval|Geometric Mean
2545332|NCT02946385|Secondary|Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y At Days 6, 31 in Follow-on Subjects in V102_15 and at Day 66, 91 in Naive Subjects, in MenABCWY Groups|The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA.|At Day 6 and 31(after booster dose of MenABCWY given at 24 months after last MenABCWY vaccination) in ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 groups and at Day 66 and 91(i.e. day 6 and 1 month after dose 2 of MenABCWY) in Naive_ABCWY Group|All subjects in FAS immunogenicity(Days 6 and 31, after booster[follow-on]/D66 and 91 after dose 2[naive]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.|||Percentage of subjects||95% Confidence Interval|Number
2545333|NCT02946385|Secondary|Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and N. Meningitidis Serogroups A, C, W and Y at 24 Months At Days 1, 6, 31 in V102_15 Follow-on Subjects and at Day 1, 66, 91 in Naive Subjects, in MenABCWY Groups|The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with HT-hSBA titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.|At Day 1, Day 6 and 31(after booster dose of MenABCWY given at 24 months after last MenABCWY vaccination) in ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 groups and at Day 1, Day 66 and 91(i.e. day 6 and 1 month after dose 2 of MenABCWY) in Naive_ABCWY Group|All subjects in FAS immunogenicity(Days 6 and 31, after booster [follow-on]/D66 and 91 after dose 2[naive]) who were randomized(if naive), received at least 1 study vaccination and provided evaluable results for at least 1 serogroup B strain or serogroups A, C, W, Y at D1, and at least at D6 or D31(follow-on)/D 66 or D91(naive) in extension study.|||Percentage of subjects||95% Confidence Interval|Number
2545334|NCT02946385|Secondary|hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1|The immunogenicity of MenABCWY vaccine, was measured as the HT-hSBA Geometric Mean Titers (GMTs) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y . The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.|Day 31: One month after a booster dose of MenABCWY given at 24 months after last MenABCWY vaccination in groups: ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 and after first dose of MenABCWY in Naive_ABCWY Group|All subjects in the FAS immunogenicity (Day 31, after booster dose[follow-on]/first dose[naive]) who were randomized (if naive), received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain or serogroups A, C, W or Y at Day 31 in the extension study.|||Titers||95% Confidence Interval|Geometric Mean
2545335|NCT02946385|Secondary|Percentages of Subjects With 4-Fold Increase in HT-hSBA Titers Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1|The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with 4-Fold Increase in HT-hSBA Titers against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. The 4-fold titer rise is defined as: a) for subjects with pre-vaccination hSBA titers ˂ LLOQ, a post-vaccination hSBA ≥ 4 LLOQ; b) for subjects with a pre-vaccination hSBA titers ≥ LLOQ, an increase of at least 4 times of the pre-vaccination hSBA.|Day 31: One month after a booster dose of MenABCWY given at 24 months after last MenABCWY vaccination in groups: ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 and after first dose of MenABCWY in Naive_ABCWY Group|All subjects in the FAS immunogenicity (Day 31, after booster dose[follow-on]/first dose[naive]) who were randomized (if naive), received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain or serogroups A, C, W or Y at Day 31 in the extension study.|||Percentage of subjects||95% Confidence Interval|Number
2550639|NCT02829944|Secondary|Number of Subjects Experiencing Pruritus|Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable|24 hours||||units on a scale||Inter-Quartile Range|Median
2545336|NCT02946385|Secondary|Percentages of Subjects With HT-hSBA Titers ≥ LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at Day 31 After MenABCWY Vaccination in V102_15E1|The immunogenicity of MenABCWY vaccine, was measured as the percentages of subjects with HT-hSBA titers greater than or equal to (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.|Day 31: One month after a booster dose of MenABCWY given at 24 months after last MenABCWY vaccination in groups: ABCWY_0_2, ABCWY_0_6 and ABCWY_0_2_6 and after first dose of MenABCWY in Naive_ABCWY Group|All subjects in the FAS immunogenicity (Day 31, after booster dose[follow-on]/first dose[naive]) who were randomized (if naive), received at least one study vaccination and provided evaluable serum sample with results for at least one serogroup B test strain or serogroups A, C, W or Y at Day 31 in the extension study.|||Percentage of subjects||95% Confidence Interval|Number
2545337|NCT02946385|Primary|hSBA GMTs Against Each of Four Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects|The immunogenicity of MenABCWY or rMenB+OMV vaccines, is measured as the HT-hSBA geometric mean titers (GMTs) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.|At 24 months after the last meningococcal vaccination for all follow-on subjects and at Day 1 in the extension study for naive subjects|Subjects in full analysis set(FAS) persistence(24 months after last vaccination in V102_15/Day 1)who were randomized(if naive) & provided evaluable serum sample with hSBA results for atleast 1 serogroup B test strain/serogroups A,C,W/Y at Day 1 in extension study.Subjects in group B_0_2 did not receive MenACWY vaccination in the parent study.|||Titers||95% Confidence Interval|Geometric Mean
2545338|NCT02946385|Primary|Percentages of Subjects With hSBA Titers ≥LLOQ Against 4 Serogroup B Test Strains, and Against N. Meningitidis Serogroups A, C, W and Y at 24 Months After Last Meningococcal Vaccination in Follow-on Subjects in V102_15 and at Day 1 in Naive Subjects|The immunogenicity of MenABCWY or rMenB+OMV vaccines, is measured as the percentage of subjects with High-Throughput Human Serum Bactericidal Assay (HT-hSBA) titers greater or equal than (≥) Lower limit of quantification (LLOQ) against N. meningitidis serogroup B test strains and serogroups A,C, W and Y. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.|At 24 months after the last meningococcal vaccination for all follow-on subjects and at Day 1 in the extension study for naive subjects|Subjects in full analysis set(FAS) persistence(24 months after last vaccination in V102_15/Day 1)who were randomized(if naive) & provided evaluable serum sample with hSBA results for atleast 1 serogroup B test strain/serogroups A,C,W/Y at Day 1 in extension study.Subjects in group B_0_2 did not receive MenACWY vaccination in the parent study|||Percentage of subjects||95% Confidence Interval|Number
2545339|NCT02946229|Primary|Number of Diagnostic Ultrasound Exams|Collection (number) of ultrasound images representative of sonographic findings routinely observed in the general imaging population.|1 day|No performance or efficacy data were studied; No statistical analysis was performed per the protocol.|||Participants|||Count of Participants
2545340|NCT02946021|Secondary|Ease of Use Measured by Survey Response.|Flexitouch is easy to use as measured by survey responses.|Single Treatment, 2 Weeks of Treatment|The analysis population included all enrolled subjects who completed the study and properly used the device. One subject reported wearing the head garment upside down during the two week treatment period, therefore the subject was excluded from the analysis population for a cohort of 10 analyzable data sets.|||Participants|||Count of Participants
2545341|NCT02946021|Secondary|Symptom Alleviation Measured by Survey Response.|Alleviates lymphedema symptoms as measured by survey response.|Single Treatment, 2 Weeks of Treatment|The analysis population included all enrolled subjects who completed the study and properly used the device. One subject reported wearing the head garment upside down during the two week treatment period, therefore the subject was excluded from the analysis population for a cohort of 10 analyzable data sets.|||Participants|||Count of Participants
2545342|NCT02946021|Secondary|Dermal Backflow Measured by ICG Lymphography.|Resolves dermal backflow as measured by ICG lymphography. A positive change in area indicates an increase in observable abnormal lymphatics, while a negative change indicates a decrease in observable abnormal lymphatics. A positive increase after a single treatment is expected as the manual stimulation of the lymphatics promotes the movement of ICG through the lymphatic space; however, a decrease over time provides an indication of improved lymphatic recovery.|Single Treatment, 2 Weeks of Treatment|The analysis population included all enrolled subjects who completed the study and properly used the device. One subject reported wearing the head garment upside down during the two week treatment period, therefore the subject was excluded from the analysis population for a cohort of 10 analyzable data sets.|||Participants|||Count of Participants
2545343|NCT02946021|Primary|Lymph Movement Measured by ICG Lymphography.|Demonstrate the ability of the Flexitouch system to move lymph/enhance lymphatic uptake (indicated by increased functionality of vessels and/or changes in area of dermal backflow) as measured by Indocyanine Green (ICG) lymphography.|Single Treatment, 2 Weeks of Treatment|The analysis population included all enrolled subjects who completed the study and properly used the device. One subject reported wearing the head garment upside down during the two week treatment period, therefore the subject was excluded from the analysis population for a cohort of 10 analyzable data sets.|||Participants|||Count of Participants
2545344|NCT02945657|Secondary|Clinically Meaningful ECG Median Changes From Baseline to Day 29|Number of Participants With Clinically Meaningful ECG Median Changes from Baseline. Clinical meaningfulness of ECG changes was determined at the investigator's discretion.|Day 29|Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment|||participants|||Number
2545345|NCT02945657|Secondary|Clinically Meaningful ECG Median Changes From Baseline to Day 15|Number of Participants With Clinically Meaningful ECG Median Changes from Baseline. Clinical meaningfulness of ECG changes was determined at the investigator's discretion.|Day 15|Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment|||participants|||Number
2548510|NCT02875977|Secondary|Initiation of PFPT|The number of patients who initiated PFPT is compared between those assigned to enhanced counseling versus standard counseling|3 months|This analysis comprises all participants who were randomized|||Participants|||Count of Participants
2545346|NCT02945657|Secondary|Clinically Meaningful Vital Sign Median Changes From Baseline|Number of Participants With Clinically Meaningful Vital Sign Median Changes From Baseline. Clinical meaningfulness of vital sign changes was determined at the investigator's discretion.|Day 29|Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment|||participants|||Number
2545347|NCT02945657|Secondary|Clinically Meaningful Laboratory Test Median Changes From Baseline|Number of Participants With Clinically Meaningful Laboratory Test Median Changes From Baseline. Clinical meaningfulness of laboratory test changes was determined at the investigator's discretion.|Day 29|Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment|||participants|||Number
2545348|NCT02945657|Secondary|Application Site Adverse Events (AEs) According to Severity|Number of Participants With Application Site Adverse Events (AEs) According to Severity. Adverse events were classified according to severity as: mild - an event that is usually transient in nature and generally not interfering with normal activities; moderate - an event that is sufficiently discomforting to interfere with normal activities; severe - an event that is incapacitating with inability to work or do usual activity or inability to work or perform normal daily activity.|up to 4 weeks|Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment|||participants|||Number
2545349|NCT02945657|Secondary|Application Site Adverse Events (AEs)|Number of Participants With Application Site Adverse Events (AEs)|up to 4 weeks|Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment|||participants|||Number
2545350|NCT02945657|Secondary|Treatment-Emergent Adverse Events (AEs) According to Severity|Number of Participants With Treatment-Emergent Adverse Events (AEs) According to Severity. Adverse events were classified according to severity as: mild - an event that is usually transient in nature and generally not interfering with normal activities; moderate - an event that is sufficiently discomforting to interfere with normal activities; severe - an event that is incapacitating with inability to work or do usual activity or inability to work or perform normal daily activity.|up to 4 weeks|Safety population included all subjects in the ITT population who had at least one post-baseline safety assessment|||participants|||Number
2545351|NCT02945657|Secondary|Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|up to 4 weeks|Safety population included all subjects in the Intent to treat (ITT) population who had at least one post-baseline safety assessment|||participants|||Number
2545352|NCT02945657|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36|Area Under the Plasma Concentration-Time Curve From Time Zero To the time of Last Quantifiable Plasma Concentration of MM36 on Day 15|Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15|Pharmacokinetic (PK) population included participants in the Safety Population with PK Data|||ng·hr/mL||Standard Deviation|Mean
2545353|NCT02945657|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero To the Time of Last Quantifiable Plasma Concentration of MM36|Area Under the Plasma Concentration-time Curve from Time Zero To the time of Last Quantifiable Plasma Concentration of MM36 on Day 1|Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1|Pharmacokinetic (PK) population included participants in the Safety Population with PK Data|||ng·hr/mL||Standard Deviation|Mean
2545354|NCT02945657|Primary|Time of Maximum Observed Plasma Concentration (Tmax) of MM36|Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 15|Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15|Pharmacokinetic (PK) population included participants in the Safety Population with PK Data|||hours||Standard Deviation|Mean
2545355|NCT02945657|Primary|Time of Maximum Observed Plasma Concentration (Tmax) of MM36|Time of Maximum Observed Plasma Concentration (Tmax) of MM36 on Day 1|Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1|Pharmacokinetic (PK) population included participants in the Safety Population with PK Data|||hours||Standard Deviation|Mean
2545356|NCT02945657|Primary|Maximum Observed Plasma Concentration (Cmax) of MM36|Maximum observed plasma concentration of MM36 after two weeks of twice daily application (steady state)|Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 15|Pharmacokinetic (PK) population included participants in the Safety Population with PK Data|||ng/mL||Standard Deviation|Mean
2545357|NCT02945657|Primary|Maximum Observed Plasma Concentration (Cmax) of MM36|Maximum observed plasma concentration of MM36 on Day 1|Pre-dose (0 hour), 1, 4, and 8 hours post-dose on Day 1|Pharmacokinetic (PK) population included participants in the Safety Population with PK Data|||ng/mL||Standard Deviation|Mean
2545358|NCT02945410|Secondary|Change in Perceived Hunger|Perceived hunger will be assessed using 0-100 visual analog scales. In this case, 100 means maximum hunger while 0 means minimal hunger.|Baseline and day 6||||units on a scale||Standard Error|Mean
2545359|NCT02945410|Secondary|Change in Aerobic Fitness (VO2peak)|Analyzed in L/min rather than mL/kg/min to remove influence of weight loss.|Baseline and day 6|n = 1 participants had data missing from post-testing in one condition due to equipment failure so their data for the other conditions was removed|||L/min change||Standard Error|Mean
2545360|NCT02945410|Secondary|Change in Body Fat Percentage||Baseline and day 6|Due to equipment errors, n = 5 participants had complete body composition data for all conditions.|||% change||Standard Error|Mean
2545361|NCT02945410|Secondary|Change in Body Weight||Baseline and day 6||||kg||Standard Error|Mean
2545362|NCT02945410|Primary|Change in Marker of Bone Resorption (CTx)||Baseline and day 6||||% change||Standard Error|Mean
2545363|NCT02945410|Primary|Change in Marker of Bone Formation (P1NP)||Baseline and day 6|Participants who completed all conditions.|||% change||Standard Error|Mean
2545364|NCT02945410|Primary|Change in Circulating IGF-1||Baseline and day 6|All participants completing each condition.|||mol/L change||Standard Error|Mean
2545365|NCT02945410|Primary|Change in Resting Metabolic Rate||Baseline and day 6||||kcal change||Standard Error|Mean
2545366|NCT02945254|Secondary|Subjective Sleep Quality (VAS)|subjective sleep quality was assessed in the morning with a visual analog scale (VAS) ranging from 1 (worse quality) to 10 (best quality)|1 night||||units on a scale||Inter-Quartile Range|Median
2545367|NCT02945254|Primary|Sleep Onset Latency (Mins)|time from lights out to the first epoch of stage 2 NREM sleep|1 night||||minutes||Inter-Quartile Range|Median
2545368|NCT02945150|Secondary|Number of Subjects With Undetectable Serum HCV RNA at Study Day 7, 14, 28, 56, 84, 112, 168, 252, 365|Subjects had Hepatitis C viral load assessed at each study visit. Here we looked at the proportion of subjects with undetectable serum HCV RNA at study day 7, 14, 28, 56, 84, 112, 168, 252, 365.|1 year post transplant|Results anticipated by April 1, 2020.|||participants|||Number
2545369|NCT02945150|Primary|Number of Participants With Undetectable HCV RNA at SVR12|Sustained virologic response at 12-weeks post-treatment (SVR12), as defined by negative HCV viral load, after 12-16 weeks of elbasvir/grazoprevir treatment in patients who receive a kidney transplant from a deceased donor infected with HCV.|12 weeks post-treatment (24 weeks post-transplant)||||Participants|||Count of Participants
2545370|NCT02945046|Secondary|Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)|"eC-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent."|Baseline up to Week 12|Safety analysis set included all randomized participants who received at least 1 dose of the IMP.|||Participants|||Count of Participants
2545371|NCT02945046|Secondary|Number of Participants With Hypersensitivity/Anaphylaxis Reactions|A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to Week 12|Safety analysis set included all randomized participants who received at least 1 dose of the IMP.|||Participants|||Count of Participants
2545372|NCT02945046|Secondary|Number of Participants With Injection Site Reactions|Number of participants who reported treatment-emergent injection site reactions are summarized. Preferred terms from Medical Dictionary for Regulatory Activities (MedDRA) version 18.1 were offered without a threshold applied. Injection site reactions included injection site erythema, induration, pain, haemorrhage, swelling, and pruritus. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to Week 12|Safety analysis set included all randomized participants who received at least 1 dose of the IMP.|||Participants|||Count of Participants
2545373|NCT02945046|Secondary|Number of Participants Who Received Concomitant Medications|Concomitant medications included: agents acting on the renin-angiotensin system, all other therapeutic products (for example: homeopathic preparation), allergens, analgesics, anesthetics, anti-parkinson drugs, antianemic preparations, antibacterials for systemic use, antibiotics and chemotherapeutics for dermatological use, antidiarrheals, intestinal antiinflammatory/antiinfective agents, antiemetic, antiepileptics, antifungals for dermatologiocal use, antigout preparations, antihemorrhagics, antihistamines for systemic use, antihypertensives, antiinflammatory and antirheumatic products, antimycotics for systemic use, antipruritics, antipsoriatics, antivirals for systemic use, beta blocking agents, blood substitutes and perfusion solutions, cardiac therapy, corticosteroids, cough and cold preparations, diagnostic radiopharmaceuticals, diuretics, thyroid therapy, urologicals, vaccines, psycoleptics, psycoanaleptics, ophthalmologicals, muscle relaxants, drugs used in diabetes etc.|Baseline up to Week 12|Safety analysis set included all randomized participants who received at least 1 dose of the IMP.|||Participants|||Count of Participants
2545374|NCT02945046|Secondary|Number of Participants With Shift From Baseline to Endpoint (Last Assessment) in Electrocardiogram (ECG) Parameters|ECG parameters included: heart rate, PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF), QT interval corrected using the Bazett's formula (QTcB) and RR interval. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding. Missing ECG shift data are also presented. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to Week 12|Safety analysis set included all randomized participants who received at least 1 dose of the IMP.|||Participants|||Count of Participants
2545375|NCT02945046|Secondary|Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values|Potentially clinically significant abnormal vital signs findings included: pulse rate ≥120 beats per minute (bpm) and increase of 15 bpm; systolic blood pressure ≤90 millimeters of mercury (mmHg) and decrease of 20 mmHg; diastolic blood pressure ≤50 mmHg and decrease of 15 mmHg, or ≥105 mmHg and increase of 15 mmHg. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to Week 12|Safety analysis set included all randomized participants who received at least 1 dose of the IMP. Here, 'overall number of participants analyzed'=participants evaluable for this outcome measure.|||Participants|||Count of Participants
2545376|NCT02945046|Secondary|Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results|Coagulation parameters included: prothrombin time (PT) (seconds) and prothrombin international normalized ratio (INR). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Shifts from baseline to endpoint were summarized using participant counts grouped into three categories: - Low (below normal range) - Normal (within the normal range of 9.4 to 12.5 seconds) - High (above normal range). Missing PT and prothrombin INR shift data are also presented. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to Week 12|Safety analysis set included all randomized participants who received at least 1 dose of the IMP.|||Participants|||Count of Participants
2545393|NCT02944656|Secondary|Side Effects|Participants were asked if they experienced dizziness, lack of muscle control, sleepiness or drowsiness, weakness or lack of energy, headache, or visual changes.|10 and 30 minutes post procedure on Study Day 1|This analysis includes participants responding to the side effects questions. Two did not answer any questions. Two participants in the gabapentin group did not complete the side effect assessment at 30 minutes post-procedure. One participant in the placebo group did not respond to the assessment of weakness at 30 minutes post-procedure.|||Participants|||Count of Participants
2545761|NCT02938520|Secondary|Number of Participants With Confirmed Virologic Failure (CVF) During the Maintenance Phase|The CVF is defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels >=200 copies/mL after prior suppression to <200 copies/mL.|Week 48|ITT-E Population|||Participants|||Count of Participants
2545377|NCT02945046|Secondary|Number of Participants With Potentially Clinically Significant Laboratory (Serum Chemistry, Hematology, and Urinalysis) Abnormal Results|Serum chemistry, hematology, urinalysis laboratory tests with potentially clinically significant abnormal findings included: alanine aminotransferase (ALP), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), lactate dehydrogenase (LDH) each ≥3*upper limit of normal (ULN); blood urea nitrogen (BUN) ≥10.71 millimole (mmol)/L; Bilirubin (Total) ≥34.2 micromole/liter (umol/L); Blood Urea Nitrogen ≥10.71 millimoles (mmol)/L; creatinine ≥177 umol/L; hemoglobin less than or equal to (≤)115 grams (g)/L (males) or ≤95 g/L (females); leukocytes ≥20*10^9/L or ≤3*10^9/L; eosinophils ≥10%; hematocrit <0.37 L/L (males) and <0.32 L/L (females); platelets ≥700*10^9/L or ≤75*10^9/L; haemoglobin, urine glucose, ketones, urine total protein each ≥2 unit (U) increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to Week 12|Safety analysis set included all randomized participants who received at least 1 dose of the IMP. Here, 'overall number of participants analyzed'=participants evaluable for this outcome measure.|||Participants|||Count of Participants
2545378|NCT02945046|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relationship of AE to treatment was determined by the Investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to Week 12|Safety analysis set included all randomized participants who received at least 1 dose of the IMP.|||Participants|||Count of Participants
2545379|NCT02945046|Secondary|Number of Participants Who Perceived Improvement of CH-Associated Pain From Baseline as Measured by the Patient-Perceived Satisfactory Improvement (PPSI) Scale at Weeks 1, 4, 8, and 12|"The PPSI assessment was developed to measure pain intensity and was adjusted for CH symptoms improvement. Participants marked the level of CH-associated pain and indicated if pain is 1=much worse, 2=moderately worse, 3=slightly worse, 4=unchanged, 5=slightly improved, 6=moderately improved, or 7=much improved compared with 4 weeks prior. PPSI was defined as the change in pain that corresponds with a minimal rating of 5=slightly improved. Data at Week 1 was recorded on Day 7 in the electronic diary device at home. Week 12 data also included assessment at the early withdrawal visit for participants who discontinued the study early."|Baseline, Weeks 1, 4, 8, and 12|Full analysis set included all randomized participants who received at least 1 dose of IMP and had at least 10 days of postbaseline efficacy assessment in the first 4 weeks on the primary endpoint.|||Participants|||Count of Participants
2545380|NCT02945046|Secondary|Mean Change From Baseline in the Weekly Average Number of Days Oxygen Was Used to Treat Episodic Cluster Headache (ECH) During the 12-Week Period After the First Dose of the IMP|LS mean calculated using ANCOVA model with baseline preventive medication use (yes or no), gender, region (US/Canada or other), and treatment as fixed effects and the baseline number of cluster headache attacks as a covariate. Baseline data and the mean change from baseline in the overall weekly average number of days oxygen was used to treat ECH during the 12-week period after administration of the first dose of IMP (based on Week 0 to 12 data) is reported.|Baseline (Week 0), up to Week 12|Full analysis set included all randomized participants who received at least 1 dose of IMP and had at least 10 days of postbaseline efficacy assessment in the first 4 weeks on the primary endpoint.|||days of use/week||Standard Error|Least Squares Mean
2545381|NCT02945046|Secondary|Mean Change From Baseline in the Weekly Average Number of Days With Use of Cluster-Specific Acute Headache Medications (Triptans and Ergot Compounds) During the 12-Week Period After the First Dose of the IMP|A maximum of 2 concomitant preventive medications for CH were allowed during the study. Participants must have been on a stable dose and regimen of the concomitant medication for at least 2 weeks before screening and throughout the study. LS mean calculated using ANCOVA model with baseline preventive medication use (yes or no), gender, region (US/Canada or other), and treatment as fixed effects and the baseline number of cluster headache attacks as a covariate. Baseline data and the mean change from baseline in the overall weekly average number of days with the use of cluster-specific acute headache medications (triptans and ergot compounds) during the 12-week period after administration of the first dose of study drug (based on Week 0 to 12 data) is reported.|Baseline (Week 0), up to Week 12|Full analysis set included all randomized participants who received at least 1 dose of IMP and had at least 10 days of postbaseline efficacy assessment in the first 4 weeks on the primary endpoint.|||days of use/week||Standard Error|Least Squares Mean
2545382|NCT02945046|Secondary|Mean Change From Baseline in Weekly Average Number of CH Attacks During the 4-Week Period After Administration of the Third Dose of the IMP|A CH attack was defined as a severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes with either or both of the following 2 categories: 1) at least 1 of the following symptoms or signs, ipsilateral to the headache: -conjunctival injection and/or lacrimation; -nasal congestion and/or rhinorrhea; -eyelid edema; -forehead and facial sweating; -forehead and facial flushing; -sensation of fullness in the ear; -miosis and/or ptosis. 2) a sense of restlessness or agitation. LS mean calculated using MMRM with baseline preventive medication use (yes or no), gender, region (US/Canada or other), treatment, month, and month-by-treatment interaction as fixed effects and baseline number of CH attacks as a covariate. Change from baseline in the overall weekly average number of CH attacks during the 4-week period after administration of the first dose of study drug (based on Week 8 to 12 data) is reported.|Baseline (Week 0), Week 8 up to Week 12|Full analysis set included all randomized participants who received at least 1 dose of IMP and had at least 10 days of postbaseline efficacy assessment in the first 4 weeks on the primary endpoint. Here, 'overall number of participants analyzed'=participants evaluable for this outcome measure.|||CH attacks/week||Standard Error|Least Squares Mean
2545394|NCT02944656|Secondary|Anxiety Levels|"Participants reported how much anxiety they were currently experiencing on a 100-point scale where No Anxiety is scored as 0 and Extremely Anxious is scored as 100. Anxiety is reported for the time periods of immediately prior to the procedure, 10 minutes after the procedure, and 30 minutes after the procedure."|Pre-procedure through post-procedure on Study Day 1|Participants completing all assessments on the day of the procedure are included in this analysis.|||score on a scale||Inter-Quartile Range|Median
2545383|NCT02945046|Secondary|Mean Change From Baseline in Weekly Average Number of CH Attacks During the 12-Week Period After Administration of the First Dose of the IMP|A CH attack was defined as a severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes with either or both of the following 2 categories: 1) at least 1 of the following symptoms or signs, ipsilateral to the headache: -conjunctival injection and/or lacrimation; -nasal congestion and/or rhinorrhea; -eyelid edema; -forehead and facial sweating; -forehead and facial flushing; -sensation of fullness in the ear; -miosis and/or ptosis. 2) a sense of restlessness or agitation. LS mean calculated using mixed model for repeated measures (MMRM) with baseline preventive medication use (yes or no), gender, region (US/Canada or other), treatment, month, and month-by-treatment interaction as fixed effects and baseline number of CH attacks as a covariate. Change from baseline in the overall weekly average number of CH attacks during the 12-week period after administration of the first dose of study drug (based on Week 0 to 12 data) is reported.|Baseline (Week 0), up to Week 12|Full analysis set included all randomized participants who received at least 1 dose of IMP and had at least 10 days of postbaseline efficacy assessment in the first 4 weeks on the primary endpoint.|||CH attacks/week||Standard Error|Least Squares Mean
2545384|NCT02945046|Secondary|Percentage of Participants With a ≥50% Reduction From Baseline in the Weekly Average Number of CH Attacks During the 4-Week Period After the First Dose of the IMP|A CH attack was defined as a severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes with either or both of the following 2 categories: 1) at least 1 of the following symptoms or signs, ipsilateral to the headache: -conjunctival injection and/or lacrimation; -nasal congestion and/or rhinorrhea; -eyelid edema; -forehead and facial sweating; -forehead and facial flushing; -sensation of fullness in the ear; -miosis and/or ptosis. 2) a sense of restlessness or agitation.|Baseline (Week 0), up to Week 4|Full analysis set included all randomized participants who received at least 1 dose of IMP and had at least 10 days of postbaseline efficacy assessment in the first 4 weeks on the primary endpoint.|||percentage of participants|||Number
2545385|NCT02945046|Primary|Mean Change From Baseline in the Weekly Average Number of Cluster Headache (CH) Attacks During the 4-Week Period After Administration of the First Dose of the IMP|A CH attack was defined as a severe or very severe unilateral orbital, supraorbital, and/or temporal pain lasting 15 to 180 minutes with either or both of the following 2 categories: 1) at least 1 of the following symptoms or signs, ipsilateral to the headache: -conjunctival injection and/or lacrimation; -nasal congestion and/or rhinorrhea; -eyelid edema; -forehead and facial sweating; -forehead and facial flushing; -sensation of fullness in the ear; -miosis and/or ptosis. 2) a sense of restlessness or agitation. Least Squares (LS) mean calculated using analysis of covariance (ANCOVA) model with baseline preventive medication use (yes or no), sex, region (United States [US]/Canada or other), and treatment as fixed effects and the baseline number of CH attacks as a covariate. Change from baseline in the overall weekly average number of CH attacks during the 4-week period after administration of the first dose of study drug (based on Week 0 to 4 data) is reported.|Baseline (Week 0), up to Week 4|Full analysis set included all randomized participants who received at least 1 dose of IMP and had at least 10 days of postbaseline efficacy assessment in the first 4 weeks on the primary endpoint.|||CH attacks/week||Standard Error|Least Squares Mean
2545386|NCT02944968|Secondary|Number of Participants With Early Onset Primary Adverse Events in Total Safety Population|Primary adverse events include Death, Atrio-Esophageal Fistula, Cardiac Tamponade/Perforation, Myocardial Infarction, Stroke/Cerebrovascular Accident, Thromboembolism, Transient Ischemic Attack, Diaphragmatic Paralysis, Pneumothorax, Heart Block, Pulmonary Vein Stenosis, Pulmonary Edema (Respiratory Insufficiency), Vagal Nerve Injury, Pericarditis, Major Vascular Access Complication/Bleeding, Pulmonary vein (PV) stenosis and atrio-esophageal fistula|Seven Days Post Procedure|Total Safety Population: includes subjects enrolled under CIP v1.0 and 2.0 who underwent study procedure with investigational device.|||Participants|||Count of Participants
2545387|NCT02944968|Primary|Number of Participants With Entrance Block Confirmation in the Total Effectiveness Outcome Population|Confirmation of entrance block in all targeted PVs after adenosine and/or isoproterenol challenge achieved at the end of procedure. If the challenge was not done, confirmation data would not be available.|Day of ablation procedure|This total effectiveness outcome population includes all subjects (under both protocols v1.0 and v2.0), complied with study inclusion and exclusion criteria, received investigational device, and had an adenosine challenge applied for verifying entrance block.|||Participants|||Count of Participants
2545388|NCT02944656|Secondary|Overall Satisfaction With the Procedure|Overall satisfaction with the procedure was assessed on a 10-point scale on the day after the procedure, where 1 = very dissatisfied and 10 = very satisfied.|Postoperative Day 1|Participants completing the follow up assessment one day after the procedure are included in this analysis.|||Participants|||Count of Participants
2545389|NCT02944656|Secondary|Vomiting Since Leaving Clinic|During the Postoperative Day 1 phone call, participants self reported whether or not they had vomited since leaving the clinic.|Postoperative Day 1|Participants completing the follow up assessment one day after the procedure are included in this analysis.|||Participants|||Count of Participants
2545390|NCT02944656|Secondary|Nausea or Vomiting at Postoperation Follow-up Assessment|During the Postoperative Day 1 phone call, participants self reported how much they experienced nausea or vomiting in the last 24 hours where 10 = none of the time and 0 = all of the time. Nausea and vomiting were self-reported together as a single outcome.|Postoperative Day 1|Participants completing the follow up assessment one day after the procedure are included in this analysis.|||units on a scale||Standard Deviation|Mean
2545391|NCT02944656|Secondary|Severe Pain at Postoperation Follow-up Assessment|"During the Postoperative Day 1 phone call, participants self reported how much they experienced severe pain in the last 24 hours where 10 = none of the time and 0 = all of the time. Severe pain was defined according to the perception of each participant."|Postoperative Day 1|Participants completing the follow up assessment one day after the procedure are included in this analysis.|||units on a scale||Standard Deviation|Mean
2545392|NCT02944656|Secondary|Moderate Pain at Postoperation Follow-up Assessment|"During the Postoperative Day 1 phone call, participants self reported how much they experienced moderate pain in the last 24 hours where 10 = none of the time and 0 = all of the time. Moderate pain was defined according to the perception of each participant."|Postoperative Day 1|Participants completing the follow up assessment one day after the procedure are included in this analysis.|||units on a scale||Standard Deviation|Mean
2545395|NCT02944656|Secondary|Perioperative Vomiting|Participants reported if they vomited during the perioperative period to assess changes in vomiting incidences between the study arms. Vomiting is reported for the time periods of immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure.|Pre-procedure through post-procedure on Study Day 1|Participants completing all assessments on the day of the procedure are included in this analysis.|||Participants|||Count of Participants
2545396|NCT02944656|Secondary|Perioperative Nausea|"Nausea level was measured using a 100-mm visual analog scale (VAS) to log the change in nausea levels between the study arms. No nausea is reported as 0 while worst nausea I have ever felt is reported at 100. Nausea was reported immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure."|Pre-procedure through post-procedure on Study Day 1|Participants completing all assessments on the day of the procedure are included in this analysis.|||score on a scale||Inter-Quartile Range|Median
2545397|NCT02944656|Secondary|Number of Participants Using Pain Medication|The number of participants reporting filling and using the prescription for ibuprofen postoperatively. During the follow-up phone call on the day after the procedure, participants were asked whether or not they filled the pain medication prescription and if they took any of the medication.|Postoperative Day 1|Participants completing the follow up assessment one day after the procedure are included in this analysis.|||Participants|||Count of Participants
2545398|NCT02944656|Secondary|Perioperative Pain Level|"Pain level at a variety of time points will be measured using a 100-mm visual analog scale (VAS) to log the change in pain levels between the study arms. No pain is scored as 0 and worst pain imaginable is scored as 100. Pain will be assessed immediately prior to the procedure, at completion of the procedure (removal of the speculum), 10 minutes following the procedure, and 30 minutes following the procedure (at discharge)."|Pre-procedure through post-procedure on Study Day 1|Participants completing all assessments on the day of the procedure are included in this analysis.|||score on a scale||Standard Error|Mean
2545399|NCT02944656|Primary|Pain at Time of Uterine Evacuation|"The primary outcome measure is a pain score using a 100-mm visual analog scale (VAS) measured intraoperatively at time of evacuation. No pain is scored as 0 and worst pain imaginable is scored as 100."|During the procedure on Study Day 1|Participants completing all assessments on the day of the procedure are included in this analysis.|||score on a scale||Standard Error|Mean
2545400|NCT02944565|Secondary|Infusion-related Reactions (IRR)|IRR will be assessed during the first infusion using the accelerated dosing regimen. Number of patients who develop grade 3 or above IRR utilizing the accelerated infusion will be used for safety analysis.|Up to 6 months||||participants with IRR|||Number
2545401|NCT02944565|Secondary|Incidence of Adverse Events Defined as Grade 3-4 Reactions Assessed by Common Terminology Criteria for Adverse Events (CTCAE)|Analysis of AEs possibly, probably, or definitely related to protocol therapy will summarize infusion related grade 3-4 reactions.|Up to 6 months||||Participants|||Count of Participants
2545402|NCT02944565|Primary|Total Daratumumab Infusion Time|The start and stop times of daratumumab infusion will be tracked during infusion acceleration.|Up to 6 months||||hours||Full Range|Median
2545403|NCT02944513|Secondary|Post-study Helpfulness Questionnaire|The questionnaire asked the participants to rate how helpful was the device for the low back pain on a scale of 0-10. 0 is not helpful at all and 10 is very helpful. Higher value means better outcome.|3 months|For the experimental group, 35 subjects were consented, 4 subjects dropped out, 2 subjects did not complete the 3-month questionnaire, so 29 subjects were analyzed. For the control group, 33 subjects were consented, 1 subject dropped out, 1 subject did not complete the 3-month questionnaire, so 31 subjects were analyzed.|||score on a scale||Standard Deviation|Mean
2545404|NCT02944513|Primary|Hospital Anxiety and Depression Scale Total Score|Hospital Anxiety and Depression Scale (HADS) is commonly used to determine the levels of anxiety and depression that a person is experiencing. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. This outcome is a total score, which was calculated by adding the anxiety score and the depression score. Total score ranges from 0-42, with higher scores indicating a worse outcome.|3 months|For the experimental group, 35 subjects were consented, 4 subjects dropped out, 2 subjects did not complete the 3-month questionnaire, so 29 subjects were analyzed. For the control group, 33 subjects were consented, 1 subject dropped out, 1 subject did not complete the 3-month questionnaire, so 31 subjects were analyzed.|||score on a scale||Standard Deviation|Mean
2545405|NCT02944513|Primary|Pain Catastrophizing Scale|Pain Catastrophizing Scale (PCS) has thirteen statements describing different thoughts and feelings that may be associated with pain. Using a 5-point scale from 0 (Not at all) to 4 (all the time), people indicate the degree to which they have these thoughts and feelings when they are experiencing pain. The sum has a minimum of 0 and a maximum of 52. Higher scores mean high levels of pain catastrophizing and worse outcome.|3 months|For the experimental group, 35 subjects were consented, 4 subjects dropped out, 2 subjects did not complete the 3-month questionnaire, so 29 subjects were analyzed. For the control group, 33 subjects were consented, 1 subject dropped out, 1 subject did not complete the 3-month questionnaire, so 31 subjects were analyzed.|||score on a scale||Standard Deviation|Mean
2545406|NCT02944513|Primary|Pain Disability Index|The Pain Disability Index (PDI) a simple and rapid instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. For each of the 7 categories of life activity listed, a score of 0 means no disability at all, and a score of 10 signifies that all of the activities in which you would normally be involved have been totally disrupted or prevented by your pain. The minimal index is 0 and maximal index is 70. The higher the index the greater the person's disability due to pain meaning a worse outcome.|3 months|For the experimental group, 35 subjects were consented, 4 subjects dropped out, 2 subjects did not complete the 3-month questionnaire, so 29 subjects were analyzed. For the control group, 33 subjects were consented, 1 subject dropped out, 1 subject did not complete the 3-month questionnaire, so 31 subjects were analyzed.|||score on a scale||Standard Deviation|Mean
2545505|NCT02940886|Secondary|Hb Concentration Increase of ≥2 g/dL From Baseline to Week 1, 2, 4, and 8|"Efficacy~Results show responders to the treatment. A subject was considered a Hb responder to a certain week if an increase in Hb of at least 2 g/dL from baseline to the week in question was observed (week 1, 2, 4, and 8)."|Baseline, week 1, 2, 4, and 8|ITT. All randomised subjects.|||Participants|||Count of Participants
2545407|NCT02944513|Primary|Average Pain Interference|This measures the average pain interference with general activity, mood, walking ability, normal work, relations with others, sleep and enjoyment of life using visual analogue scale. On a scale of 0-10, 0 is no interference and 10 is extreme interference. Higher scores mean worse outcome.|3 months|For the experimental group, 35 subjects were consented, 4 subjects dropped out, 2 subjects did not complete the 3-month questionnaire, so 29 subjects were analyzed. For the control group, 33 subjects were consented, 1 subject dropped out, 1 subject did not complete the 3-month questionnaire, so 31 subjects were analyzed.|||score on a scale||Standard Deviation|Mean
2545408|NCT02944513|Primary|Pain Intensity (Average)|Rate average pain intensity using visual analog scale on a scale of 0-10, where 0 is no pain and 10 is worst possible pain. Higher scores mean a worse outcome.|3 months|For the experimental group, 35 subjects were consented, 4 subjects dropped out, 2 subjects did not complete the 3-month questionnaire, so 29 subjects were analyzed. For the control group, 33 subjects were consented, 1 subject dropped out, 1 subject did not complete the 3-month questionnaire, so 31 subjects were analyzed.|||score on a scale||Standard Deviation|Mean
2545409|NCT02944461|Secondary|The Percent Change in Total Lesion Count at Week 16 Compared to Baseline||16 Weeks||||percent change in lesion count||Standard Deviation|Mean
2545410|NCT02944461|Secondary|The Percent Change in Non-inflammatory Lesion Count at Week 16 Compared to Baseline||16 Weeks||||percent change in lesion count||Standard Deviation|Mean
2545411|NCT02944461|Secondary|The Percent Change in Inflammatory Lesion Count at Week 16 Compared to Baseline||16 Weeks||||percent change in lesion count||Standard Deviation|Mean
2545412|NCT02944461|Primary|Percent of Subjects Who Achieve at Least a Two Grade Improvement and a Rating of Clear or Almost Clear on the Investigator Global Assessment (IGA) Scale|Investigator will evaluate global acne severity using the IGA scale as follows: 1= Clear Skin, 2 = Almost Clear, 3 = Mild Severity, 4 = Severe, 5 = Very Severe|16 weeks||||Participants|||Count of Participants
2545413|NCT02943941|Secondary|Change in PAP as Measured After Mild Exertion Compared to Initial Baseline PAP at Rest.||Same day as enrollment (during office visit, maximum of 10 minutes after baseline measurement)||||mmHg||Standard Deviation|Mean
2545414|NCT02943941|Secondary|Change in PAP During Change in Respiration|Outcome measure defined as PAP during coughing compared to PAP during normal breathing respiration at baseline.|Same day as enrollment (during office visit, maximum of 30 minutes after baseline measurement)||||mmHg||Standard Deviation|Mean
2545415|NCT02943941|Primary|Mean Change in Pulmonary Artery Pressure (PAP) Due to Change in Posture|Posture defined as lying left side down compared to baseline supine|Same day as enrollment (during office visit, maximum of 30 minutes after baseline masurement)|Only 14 patients able to provide data to contribute to analysis.|||mmHg||Standard Deviation|Mean
2545416|NCT02943577|Secondary|Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population|The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.|Baseline and Day 8|The baseline population for placebo non-responders is 284.|||Score on a Scale||Standard Error|Least Squares Mean
2545417|NCT02943577|Secondary|Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population|The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.|Baseline and Day 21|The baseline population for placebo non-responders is 284.|||Score on a Scale||Standard Error|Least Squares Mean
2545418|NCT02943577|Secondary|Change From Baseline in MADRS Total Score|The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.|Baseline and Day 8||||Score on a Scale||Standard Error|Least Squares Mean
2545419|NCT02943577|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Study|The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.|Baseline and 3 Weeks|The modified Intent-to-Treat (mITT) Population will consist of all patients who were randomized, received at least 1 dose of IP during the randomized treatment period, and had at least 1 post-randomization assessment of the MADRS total score|||Score on a Scale||Standard Error|Least Squares Mean
2545420|NCT02943564|Secondary|Change From Baseline in MADRS Total Score|The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.|Baseline and Day 8|The modified Intent-to-Treat (mITT) Population will consist of all patients who were randomized, received at least 1 dose of IP during the randomized treatment period, and had at least 1 post-randomization assessment of the MADRS total score|||Score on a Scale||Standard Error|Least Squares Mean
2545506|NCT02940886|Secondary|S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8|"Safety~Results show the number of subjects who had s-phosphate <2 mg/dL at any time from baseline to week 1, 2, 4, or 8."|Baseline, week 1, 2, 4, and 8|Safety analysis set. All randomised subjects who received at least one dose of the investigational product.|||Participants|||Count of Participants
2545421|NCT02943564|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Study|The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.|Baseline and 3 Weeks|The modified Intent-to-Treat (mITT) Population will consist of all patients who were randomized, received at least 1 dose of IP during the randomized treatment period, and had at least 1 post-randomization assessment of the MADRS total score|||Score on a Scale||Standard Error|Least Squares Mean
2545422|NCT02943499|Primary|Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal|BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping|1 month||||BOLD signal||Standard Deviation|Mean
2545423|NCT02943460|Primary|Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities During the Blinded Phase|Treatment-emergent laboratory abnormalities occurring during the Blinded Phase were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug in the Blinded Phase plus 30 days. The Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 was used for assigning toxicity grades (0 to 4, with higher grades indicating more severity).|Up to 12 weeks plus 30 days|Participants in the Safety Analysis Set were analyzed.|||percentage of participants|||Number
2545424|NCT02943460|Primary|Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events During the Blinded Phase|A serious adverse event was defined as an event that, at any dose, resulted in any of the following: death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or a medically important event or reaction.|Up to 12 weeks plus 30 days|Participants in the Safety Analysis Set were analyzed.|||percentage of participants|||Number
2545425|NCT02943460|Primary|Percentage of Participants Experiencing Treatment-Emergent Adverse Events During the Blinded Phase|Treatment-emergent adverse events occurring during the Blinded Phase were defined as 1 or both of the following: 1) Any adverse events (AEs) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug in the Blinded Phase (and before the first dosing date in the Open Label Extension (OLE) Phase), or 2) Any AEs leading to premature discontinuation of study drug in the Blinded Phase.|Up to 12 weeks plus 30 days|Safety Analysis Set included all participants who took at least 1 dose of study drug.|||percentage of participants|||Number
2545426|NCT02943447|Primary|Percentage of Participants Who Experienced Graded Laboratory Abnormalities in the OLE Phase|Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.|First dose date in the OLE phase up to data cut (approximately 72 weeks)|Participants in the OLE Analysis Set were analyzed.|||percentage of participants|||Number
2545427|NCT02943447|Primary|Percentage of Participants Who Experienced Graded Laboratory Abnormalitiesin the Blinded Study Phase|Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.|First dose date up to Week 12 + 30 days|Participants in the Safety Analysis Set were analyzed.|||percentage of participants|||Number
2545428|NCT02943447|Primary|Percentage of Participants Experiencing TEAEs and SAEs in the OLE Phase||First dose date in the OLE phase up to data cut (approximately 72 weeks)|The OLE Analysis Set included all participants who took at least 1 dose of study drug in the OLE Phase.|||percentage of participants|||Number
2545429|NCT02943447|Primary|Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious SAEs in the Blinded Study Phase||First dose date up to Week 12 + 30 days|The Safety Analysis Set included all participants who took at least 1 dose of study drug.|||percentage of participants|||Number
2545430|NCT02943226|Secondary|Injection Flow Rate|The injection flow rate is recorded in the electronic health record (EHR) during every CT examination preformed at the hospitals taking part in this study.|at the time of CT scanning||||milliliters per second (mL/sec)||Standard Deviation|Mean
2545431|NCT02943226|Secondary|Peak Contrast Infusion Pressure|The peak contrast infusion pressure is recorded in the electronic health record (EHR) during every CT examination preformed at the hospitals taking part in this study.|at the time of CT scanning|"Peak contrast infusion pressure data was not collected by the technologist for one patient in the Standard intravenous non-fenestrated catheter arm."|||Pounds per square inch (PSI)||Inter-Quartile Range|Median
2545432|NCT02943226|Primary|Image Quality as Assessed by Rating Scale|Radiologists blinded to catheter type will review images and rate them on a scale of 1 to 10. 10 indicates a better outcome.|at the time of CT scanning||||units on a scale||Standard Deviation|Mean
2545433|NCT02943226|Primary|Image Quality as Assessed by Ratio of Tissue Density of Inferior Vena Cava (IVC) to the Aorta|The ratio of tissue density measured in the inferior vena cava (IVC) to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality. Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality.|at the time of CT scanning||||Ratio||Standard Deviation|Mean
2545434|NCT02943226|Primary|Image Quality as Assessed by Ratio of Tissue Density of Spleen to the Aorta|The ratio of tissue density measured in the spleen to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality. Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality.|at the time of CT scanning|"Data for the Becton Dickinson Nexiva Diffusics System fenestrated catheter arm was not collected for one patient because the patient had a splenectomy."|||Ratio||Standard Deviation|Mean
2545549|NCT02940574|Primary|Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 4 Weeks of Nasal Spray|"Change from baseline in brain connectivity during rest (resting-state fMRI) after 4 weeks of nasal spray~Amygdala connectivity (Change-from-baseline z-transformed r-value)"|Value at 4 weeks minus value at baseline||||Change-from-base z-transformed r-value||Standard Deviation|Mean
2545435|NCT02943226|Primary|Image Quality as Assessed by Ratio of Tissue Density of Main Portal Vein (MPV) to the Aorta|The ratio of tissue density measured in the main portal vein (MPV) to tissue density in the aorta on the CT images will be determined and will provide a measure of biodistribution, which is an important indicator of image quality. Dividing each Hounsfield unit measurement by the aorta density and determining these ratios will be done on a per patient basis to assess biodistribution as a measure of image quality.|at the time of CT scanning||||Ratio||Standard Deviation|Mean
2545436|NCT02943213|Secondary|Apparent Terminal Elimination Half-life (t1/2) - 7-Hydroxy-Chlorpromazine|Time Frame = sampling times|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||hr||Geometric Coefficient of Variation|Geometric Mean
2545437|NCT02943213|Secondary|Apparent Terminal Elimination Half-life (t1/2) - Chlorpromazine|Time Frame = sampling times|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||hr||Geometric Coefficient of Variation|Geometric Mean
2545438|NCT02943213|Secondary|Terminal Elimination Rate Constant (λz) - 7-Hydroxy-Chlorpromazine|Time Frame = sampling times|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||1/hr||Geometric Coefficient of Variation|Geometric Mean
2545439|NCT02943213|Secondary|Terminal Elimination Rate Constant (λz) - Chlorpromazine|Time Frame = sampling times|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||1/hr||Geometric Coefficient of Variation|Geometric Mean
2545440|NCT02943213|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) - 7-Hydroxy-Chlorpromazine|Time Frame = sampling times|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||hr||Full Range|Median
2545441|NCT02943213|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) - Chlorpromazine|Time Frame = sampling times|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||hr||Full Range|Median
2545442|NCT02943213|Primary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞)) - 7-Hydroxy-Chlorpromazine|Time Frame = sampling times.|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2545443|NCT02943213|Primary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞)) - Chlorpromazine|Time Frame = sampling times.|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2545444|NCT02943213|Primary|Area Under the Plasma Concentration Versus Time Curve, From Time Zero to t, Where t is the Time of the Last Quantifiable Concentration (AUC(0-t)) - 7-Hydroxy-Chlorpromazine|Time Frame = sampling times.|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2545445|NCT02943213|Primary|Area Under the Plasma Concentration Versus Time Curve, From Time Zero to t, Where t is the Time of the Last Quantifiable Concentration (AUC(0-t)) - Chlorpromazine|Time Frame = sampling times.|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2545446|NCT02943213|Primary|Maximum Observed Plasma Concentration (Cmax) - 7-Hydroxy-Chlorpromazine|Time Frame = sampling times.|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2545447|NCT02943213|Primary|Maximum Observed Plasma Concentration (Cmax) - Chlorpromazine|Time Frame = sampling times.|0, 0.5, 1, 1.3, 1.6, 2, 2.5, 3, 4, 5, 6, 9, 12, 16, 24, 36, 48, 72 and 96 hours|All subjects who completed the PK blood sampling for this study and for whom primary PK parameters were calculated for both treatment periods were included in the statistical PK analysis of the study.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2545448|NCT02943096|Secondary|Mnemonic Similarity Task (MST)|"First, participants had to complete an encoding task were they were shown 128 items, ½ objects(2 seconds) and ½ scene (3 seconds). Right after, they were given instructions on a video on how to do the test phase. They were instructed to identified the following images as old, similar, or new. They were then shown 192 items: 64 old items, 64 lures (similar), and 64 foil (new) for 2.5 seconds (objects)/3 seconds (scene). The images were intermixed during the test. The Lure Discrimination Index was calculated as the difference between the rate of similar responses give to lure items minus similar responses given to foil. This corrected for response bias. Correct responses are those that were identified correctly by the participant. A negative response means that the number of answered correctly was less that those answered incorrectly."|Week 8||||Percent Endorsed||Standard Deviation|Median
2545449|NCT02943096|Secondary|Modified-Benton Task (ModBent)|The ModBent assesses pattern separation, a measure of cognitive functioning. The task was created to measure dentate gyrus-dependent cognition. It shows participants patterns for 10 seconds, then presents two patterns afterwards on a different screen. Participants are then asked to determine which of the two patterns is the one they previously studied for 10 seconds. The second component of the task then goes through a series of patterns, one by one - the participant has to then decide whether each pattern was one they previously studied for 10 seconds or not. We analyzed the mean Reaction time for correct rejections.|Baseline||||millisecond||Standard Deviation|Mean
2545450|NCT02943096|Secondary|Modified-Benton Task (ModBent)|The ModBent assesses pattern separation, a measure of cognitive functioning. The task was created to measure dentate gyrus-dependent cognition. It shows participants patterns for 10 seconds, then presents two patterns afterwards on a different screen. Participants are then asked to determine which of the two patterns is the one they previously studied for 10 seconds. The second component of the task then goes through a series of patterns, one by one - the participant has to then decide whether each pattern was one they previously studied for 10 seconds or not. We analyzed the mean Reaction time for correct rejections.|Week 8||||millisecond||Standard Deviation|Mean
2545451|NCT02943096|Secondary|Mnemonic Similarity Task (MST)|"First, participants had to complete an encoding task were they were shown 128 items, ½ objects(2 seconds) and ½ scene (3 seconds). Right after, they were given instructions on a video on how to do the test phase. They were instructed to identified the following images as old, similar, or new. They were then shown 192 items: 64 old items, 64 lures (similar), and 64 foil (new) for 2.5 seconds (objects)/3 seconds (scene). The images were intermixed during the test. The Lure Discrimination Index was calculated as the difference between the rate of similar responses give to lure items minus similar responses given to foil. This corrected for response bias. Correct responses are those that were identified correctly by the participant. A negative response means that the number of answered correctly was less that those answered incorrectly."|Baseline||||Percent Endorsed||Standard Deviation|Mean
2545452|NCT02943096|Primary|Hamilton Rating Scale of Depression (HRSD)|Scale for depressive symptoms administered by trained rater. The HRSD is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. Although the HRSD list 21 items, the scoring is based on the first 24 items. The minimum score is 0 and the maximum score is 74. The higher the number the worse outcome.|Week 8||||score on a scale||Standard Deviation|Mean
2545453|NCT02942654|Secondary|Glucodynamics (GD): Total Amount of Glucose Infused (Gtot)|Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY900014 or Insulin Lispro by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.|2.5 minutes for the first 30 minutes, then every 5 minutes until 120 minutes postdose, and then every 10 minutes until 480 minutes postdose|All randomized participants who received at least one dose of study drug and have evaluable glucodynamic data.|||Milligrams (mg)||Geometric Coefficient of Variation|Geometric Mean
2545454|NCT02942654|Primary|Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])|Area Under the Concentration Versus Time Curve (AUC) was measured from time zero to 8 hours (AUC[0-8 Hours]).|Predose (0), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 210, 240, 300, 330, 360, 420, and 480 minutes, post dose|All randomized participants who receive at least 1 dose of study drug and have measurable PK data.|||Picomoles*hour/Liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2545455|NCT02942576|Secondary|Number of Participants Who Experienced the Composite of Stroke (VARC-2), Systemic Embolic Events (SEE), and Cardiovascular (CV) Mortality in the Edoxaban Group Compared With VKA Group Among Participants Undergoing Catheter Ablation (Adjudicated Data)|"Stroke (ischemic, hemorrhagic, or undetermined) was defined by Valve Academic Research Consortium-2 (VARC-2) as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury following hemorrhage or infarction. A stroke event was based on any of the following: duration of neurological dysfunction >24 hours (h), duration of neurological dysfunction <24 h in case of imaging-documented new hemorrhage or infarction, and a neurological dysfunction resulting in death.~SEE was defined as an arterial embolism resulting in clinical ischemia, excluding the central nervous system, coronary, and pulmonary arterial circulation.~CV mortality was defined as cardiac or vascular death according to Academic Research Consortium."|Day 1 to Day 90|The composite of stroke (VARC-2), systemic embolic events (SEE), and cardiovascular (CV) mortality was assessed in the PP Analysis Set.|||Participants|||Count of Participants
2545456|NCT02942576|Secondary|Number of Participants Who Experienced the Composite of All-cause Death, Stroke (Alternative), and Major Bleeding (ISTH) in the Edoxaban Group Compared With VKA Group Among Participants Undergoing Catheter Ablation (Adjudicated Data)|"An alternative definition characterized stroke (ischemic, hemorrhagic, or undetermined) as an abrupt onset, over minutes to hours, of a focal neurological deficit in the distribution of a single brain artery that was not due to an identifiable nonvascular cause (ie, brain tumor or trauma), and that either lasted at least 24 hours or resulted in death within 24 hours of onset.~Major bleeding was defined by the International Society on Thrombosis and Hemostasis (ISTH) as fatal bleeding and/or bleeding that is symptomatic and occurs in a critical area or organ and/or extrasurgical site bleeding causing a fall in hemoglobin level of >2 g/dL or leads to blood transfusion, surgical site bleeding that requires a second intervention, causes hemarthrosis that delays mobilization or wound healing, or causes hemodynamic instability."|Day 1 to Day 90|The composite of all-cause death, stroke (alternative), and major bleeding (ISTH) was assessed in the PP Analysis Set.|||Participants|||Count of Participants
2545457|NCT02942576|Primary|Number of Participants Who Experienced Major Bleeding (International Society on Thrombosis and Hemostasis [ISTH]) in the Edoxaban Group Compared With VKA Group Among Participants Undergoing Catheter Ablation (Adjudicated Data)|Major bleeding was defined by the International Society on Thrombosis and Hemostasis (ISTH) as fatal bleeding and/or bleeding that is symptomatic and occurs in a critical area or organ and/or extrasurgical site bleeding causing a fall in hemoglobin level of >2 g/dL or leads to blood transfusion, surgical site bleeding that requires a second intervention, causes hemarthrosis that delays mobilization or wound healing, or causes hemodynamic instability.|Day 1 to Day 90|Major bleeding was assessed in the modified Intent-to-Treat (mITT) Analysis Set.|||Participants|||Count of Participants
2545458|NCT02942576|Primary|Number of Participants Who Experienced the Composite of All-cause Death, Stroke (VARC-2), and Major Bleeding (ISTH) in the Edoxaban Group Compared With Vitamin K Antagonist (VKA) Group in Participants Undergoing Catheter Ablation (Adjudicated Data)|"Stroke (ischemic, hemorrhagic, or undetermined) was defined by Valve Academic Research Consortium-2 (VARC-2) as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury following hemorrhage or infarction. A stroke event was based on any of the following: duration of neurological dysfunction >24 hours (h), duration of neurological dysfunction <24 h in case of imaging-documented new hemorrhage or infarction, and a neurological dysfunction resulting in death.~Major bleeding was defined by the International Society on Thrombosis and Hemostasis (ISTH) as fatal bleeding and/or bleeding that is symptomatic and occurs in a critical area or organ and/or extrasurgical site bleeding causing a fall in hemoglobin level of >2 g/dL or leads to blood transfusion, surgical site bleeding that requires a second intervention, causes hemarthrosis that delays mobilization or wound healing, or causes hemodynamic instability."|Day 1 to Day 90|The composite of all-cause death, stroke (VARC-2), and major bleeding (ISTH) was assessed in the Per Protocol (PP) Analysis Set.|||Participants|||Count of Participants
2545459|NCT02942017|Secondary|Time to Change in Antidepressant Medication|The time to first start or increase in the dose and time to first stop or decrease in the dose of any antidepressant medication.|Up to approximately 37 days|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.|||days||Full Range|Median
2545460|NCT02942017|Secondary|Percentage of Participants With Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion.|Up to approximately 37 days|The safety set included all randomized participants who started the study drug infusion.|||percentage of participants|||Number
2545461|NCT02942017|Secondary|Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score|"The GAD-7 is a participant-rated, generalized anxiety symptom severity scale. Scoring for GAD-7 generalized anxiety is calculated by assigning scores of 0 = not at all sure, 1 = several days, 2 = over half the days, and 3 = nearly every day to the response categories. The GAD-7 total score for the seven items ranges from 0 to 21, where a score of 0 to 4 = minimal anxiety, 5 to 9 = mild anxiety, 10 to 14 = moderate anxiety, and 15 to 21 = severe anxiety. The GAD-7 total score was calculated as the sum of the seven individual item scores. A negative change from baseline indicates less anxiety. A positive change from baseline indicates more anxiety."|Baseline, Hour 60, Days 7, 14, 21 and 30|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.|||score on a scale||Standard Error|Least Squares Mean
2545462|NCT02942017|Secondary|Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response|The CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved). CGI-I item employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions.|Hour 60, Days 7 and 30|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.|||percentage of participants|||Number
2545463|NCT02942017|Secondary|Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicates more severe depression. A negative change from baseline indicates less severe depression. A positive change from baseline indicates more severe depression.|Baseline, Hour 60, Days 7 and 30|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.|||score on a scale||Standard Deviation|Mean
2545464|NCT02942017|Secondary|Change From Baseline in HAM-D Individual Item Scores|The HAM-D comprises individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.|Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 60, 72, and Days 7, 14, 21, and 30|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.|||score on a scale||Standard Error|Least Squares Mean
2545550|NCT02940574|Primary|Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray|"Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After a Single Dose of Nasal Spray~Amygdala connectivity (Change-from-baseline z-transformed r-value)"|Value at 30 minutes minus value at baseline||||Change-from-base z-transformed r-value||Standard Deviation|Mean
2545465|NCT02942017|Secondary|Change From Baseline in HAM-D Bech 6 Subscale|The HAM-D Bech 6 subscale score is calculated as the sum of the following six items: Item # 1 (depressed mood), Item # 2 (feelings of guilt), Item # 7 (work and activities), Item # 8 (retardation), Item # 10 (anxiety psychic), and Item # 13 (general somatic symptoms). Each item is scored in a range of 0 to 2 or 0 to 4, with higher scores indicating a greater degree of depression. The scores were transformed to a 100-point scale with a higher score indicating a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.|Baseline, Hour 60, Days 7 and 30|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.|||score on a scale||Standard Error|Least Squares Mean
2545466|NCT02942017|Secondary|Percentage of Participants With HAM-D Remission|HAM-D remission is defined as having a HAM-D total score of ≤7. The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.|Hour 60, Days 7 and 30|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.|||percentage of participants|||Number
2545467|NCT02942017|Secondary|Percentage of Participants With HAM-D Response|The HAM-D response is defined as having a 50% or greater reduction from baseline in HAM-D total score. The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.|Hour 60, Days 7 and 30|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.|||percentage of participants|||Number
2545468|NCT02942017|Secondary|Change From Baseline in HAM-D Total Score|The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.|Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 72, and Days 7, 14 and 21|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.|||score on a scale||Standard Error|Least Squares Mean
2545469|NCT02942017|Secondary|Change From Baseline in HAM-D Total Score at Day 30|The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.|Baseline, Day 30|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
2545470|NCT02942017|Primary|Change From Baseline at 60 Hours in 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score|The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.|Baseline, Hour 60|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
2545471|NCT02942004|Secondary|Time to Change in Antidepressant Medication|The time to first start or increase in the dose and time to first stop or decrease in the dose of any antidepressant medication.|Up to approximately 37 days.|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.|||days||Full Range|Median
2545551|NCT02940574|Primary|Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 52 Weeks (Including 48 Weeks Without Nasal Spray)|Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 52 weeks (including 48 weeks without nasal spray)|Value at 52 weeks minus value at baseline||||Change from baseline Acc/reaction time||Standard Deviation|Mean
2545472|NCT02942004|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent AE (TEAE) is defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion.|Up to approximately 37 days.|The Safety Set included all randomized participants who started the study drug infusion.|||percentage of participants|||Number
2545473|NCT02942004|Secondary|Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score|"The GAD-7 is a participant-rated, generalized anxiety symptom severity scale. Scoring for GAD-7 generalized anxiety is calculated by assigning scores of 0 = not at all sure, 1 = several days, 2 = over half the days, and 3 = nearly every day to the response categories. The GAD-7 total score for the seven items ranges from 0 to 21, where a score of 0 to 4 = minimal anxiety, 5 to 9 = mild anxiety, 10 to 14 = moderate anxiety, and 15 to 21 = severe anxiety. The GAD-7 total score was calculated as the sum of the seven individual item scores. A negative change from baseline indicates less anxiety. A positive change from baseline indicates more anxiety."|Baseline, Hour 60, Days 7, 14, 21 and 30|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.|||score on a scale||Standard Error|Least Squares Mean
2545474|NCT02942004|Secondary|Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response|The CGI-I item employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions. CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved).|Hour 60, Days 7 and 30|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.|||percentage of participants|||Number
2545475|NCT02942004|Secondary|Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicates more severe depression. A negative change from baseline indicates less severe depression. A positive change from baseline indicates more severe depression.|Baseline, Hour 60, Days 7 and 30|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.|||score on a scale||Standard Error|Least Squares Mean
2545476|NCT02942004|Secondary|Change From Baseline in HAM-D Individual Item Scores|The HAM-D comprises individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.|Baseline, Hour 2, Hour 4, Hour 8, Hour 12, Hour 24, Hour 36, Hour 48, Hour 60, Hour 72 and Days 7, 14, 21 and 30|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.|||score on a scale||Standard Error|Least Squares Mean
2545477|NCT02942004|Secondary|Change From Baseline in HAM-D Bech 6 Subscale|The HAM-D Bech 6 subscale score is calculated as the sum of the following six items: Item # 1 (depressed mood), Item # 2 (feelings of guilt), Item # 7 (work and activities), Item # 8 (retardation), Item # 10 (anxiety psychic), and Item # 13 (general somatic symptoms). Each item is scored in a range of 0 to 2 or 0 to 4, with higher scores indicating a greater degree of depression. The scores were transformed to a 100-point scale with a higher score indicating a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.|Baseline, Hour 60, Days 7 and 30|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.|||score on a scale||Standard Error|Least Squares Mean
2545478|NCT02942004|Secondary|Percentage of Participants With HAM-D Remission|The HAM-D remission is defined as having a HAM-D total score of ≤7. The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.|Hour 60, Days 7 and 30|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.|||percentage of participants|||Number
2545816|NCT02937584|Primary|Specific Image-Based Airway Volume (siVaw)|Specific image-based airway volume. Average across lobe, adjusted for lobe volume. Ratio to baseline|Baseline, Day 15|ITT Population|||ratio||95% Confidence Interval|Geometric Mean
2545479|NCT02942004|Secondary|Percentage of Participants With HAM-D Response|The HAM-D response is defined as having a 50% or greater reduction from baseline in HAM-D total score. The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.|Hour 60, Days 7 and 30|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.|||percentage of participants|||Number
2545480|NCT02942004|Secondary|Change From Baseline in HAM-D Total Score|The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.|Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 72, and Days 7, 14, and 21|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.|||score on a scale||Standard Error|Least Squares Mean
2545481|NCT02942004|Secondary|Change From Baseline in HAM-D Total Score at Day 30|The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.|Baseline, Day 30|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
2545482|NCT02942004|Primary|Change From Baseline at 60 Hours in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score|The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.|Baseline, Hour 60|All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
2545483|NCT02941692|Secondary|Change in Salivary Cortisol (μg/dL)|Cortisol samples are collected at baseline, pre-post each conflict resolution discussion, and at 15, 30, and 60 minute post-task intervals.|Measured at 7 time points: Baseline, immediately before and after Conflict Resolution Task #1, Immediately after Conflict Resolution Task #2, and at 15, 30, and 60 minutes following the completion of Conflict Resolution task #2.|Three couples (6 total participants) were not included in analyses.|||μg/dL||Standard Deviation|Mean
2545484|NCT02941692|Primary|Change in Frequency of Distress Maintaining Attributions|Couples' conflict resolution discussions are video recorded and coded according to an observational coding system: the Rapid Marital Interaction Coding System, which assesses the frequency of behaviors (distress maintaining attributions and relationship enhancing attributions) during the 10 minute conflict resolution discussion. This variable is operationalized as the number of instances of distress maintaining attributions during each of two ten minute conflict resolution discussions.|Frequency of distress maintaining attrbibutions per 10 minutes|Analyses were limited to heterosexual couples with reliable data reporting in order to accommodate the data analytic approach (i.e., multilevel modeling).|||distress maintaining attributions||Standard Deviation|Mean
2545485|NCT02941640|Secondary|Hospital Stay|Length of hospitalization|30 days||||days||Standard Deviation|Median
2545486|NCT02941640|Secondary|Time of Application|Time of application of endoloop, stapler, Hem-o-lok and DS clip measured from introducing of instruments to cutting the base of appendix|120 min||||seconds||Standard Deviation|Mean
2545487|NCT02941640|Secondary|Operative Time|Time of operative procedure|120 min.||||minutes||Standard Deviation|Mean
2545488|NCT02941640|Secondary|Postoperative Complications|Complications that appear after operative procedure|30 days||||Participants|||Count of Participants
2545489|NCT02941640|Secondary|Intra-perative Complications|Complications that appear during operative procedure|120 min.||||Participants|||Count of Participants
2545490|NCT02941640|Primary|Overall Morbidity|Overall morbidity following the securing of the base of the appendix, defined as any adverse event occurring from the time of securing the base of the appendix until the 30th day.|30 days||||Participants|||Count of Participants
2545552|NCT02940574|Primary|Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 8 Weeks (Including 4 Weeks Without Nasal Spray)|"Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 8 weeks (including 4 weeks without nasal spray).~Emotion recognition from point-light displays conveying biological motion."|Value at 8 weeks minus value at baseline||||Change from baseline Acc/reaction time||Standard Deviation|Mean
2545491|NCT02940886|Secondary|Health Care Resource Use Questionnaire|"Pharmacoeconomics~Resources used by the health care staff (per administration), measured by the health care resource use questionnaire. The questionnaire assessed the time used by the health care staff during administration of the investigational product and the administration time (including the observational time). The health care participants included in the evaluation were: investigator, pharmacist, physician, study coordinator, study nurse.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the treatment groups is different (i.e. up to a factor 5 more frequent in the iron sucrose treatment group)."|Baseline|ITT. All randomised subjects.|||hours||Full Range|Median
2545492|NCT02940886|Secondary|Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire|"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)."|Baseline|ITT. All randomised subjects.|||participants|||Number
2545493|NCT02940886|Secondary|Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire|"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)."|Baseline|ITT. All randomised subjects.|||Hours||Full Range|Median
2545494|NCT02940886|Secondary|Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car|"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)."|Baseline|ITT. All randomised subjects.|||miles||Full Range|Median
2545495|NCT02940886|Secondary|Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire|"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)."|Baseline|ITT. All randomised subjects.|||US dollars ($)||Full Range|Median
2545496|NCT02940886|Secondary|Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8|"Efficacy~Change in fatigue symptoms from baseline to week 1, 2, and 8 was measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.~The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale consisted of 13 items ranging from 0 (not at all) to 4 (very much), except items #7 and #8 which are reversed scored. The total score range is 0-52.~A score of less than 30 indicated severe fatigue, and the higher the score, the better outcome/quality of life (QoL). If more than 50% of the items for a subject at a given visit were missing, the total score was not calculated.~Total score was calculated as shown below:~Total score= Sum of individual scores x 13 / Number of items answered"|Baseline, week 1, 2, and 8|ITT. All randomised subjects.|||score on a scale||Standard Deviation|Mean
2545497|NCT02940886|Secondary|Change in Concentrations of Serum Iron (S-iron) From Baseline to Week 1, 2, 4, and 8|"Efficacy~Changes in the concentrations of serum iron (s-iron) from baseline to week 1, 2, 4, and 8."|Baseline, week 1, 2, 4, and 8|ITT. All randomised subjects.|||μg/dL||Standard Deviation|Mean
2545498|NCT02940886|Secondary|Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8|"Efficacy~Changes in transferrin saturation (TSAT) from baseline to week 1, 2, 4, and 8.~TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron."|Baseline, week 1, 2, 4, and 8|ITT. All randomised subjects.|||percentage of saturation||Standard Deviation|Mean
2545499|NCT02940886|Secondary|Change in S-ferritin Concentration From Baseline to Weeks 1, 2, 4, and 8|"Efficacy~Change in s-ferritin concentration from baseline to weeks 1, 2, 4, and 8."|Baseline, week 1, 2, 4, and 8|ITT. All randomised subjects.|||ng/mL||Standard Deviation|Mean
2545500|NCT02940886|Secondary|Change in Hb Concentration From Baseline to Week 1, 2, and 4|"Efficacy~Change in Hb concentration from baseline to week 1, 2, and 4."|Baseline, week 1, 2, and 4|ITT. All randomised subjects.|||g/dL||Standard Deviation|Mean
2545501|NCT02940886|Secondary|S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8|"Efficacy~Proportion of subjects reaching the composite endpoint of s-ferritin concentration ≥100 ng/mL and TSAT of 20-50% at any time from week 1 to 8."|Week 1 to week 8|ITT. All randomised subjects.|||Participants|||Count of Participants
2545502|NCT02940886|Secondary|Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8|"Efficacy~Results show the number of participants who achieved Hb concentration increase of ≥2 g/dL at any time from week 1 to week 8."|Week 1 to week 8|ITT. All randomised subjects.|||Participants|||Count of Participants
2545503|NCT02940886|Secondary|Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8|"Efficacy~Hb concentration of >12 g/dL at any time from week 1 to week 8.~Results show the number of participants who achieved Hb concentration of >12 g/dL at any time from week 1 to week 8."|Week 1 to week 8|ITT. All randomised subjects.|||Participants|||Count of Participants
2545504|NCT02940886|Secondary|Time to Change in Hb Concentration ≥2 g/dL|"Efficacy~Time to change in Hb concentration ≥2 g/dL. Subjects who achieved Hb concentration increase of ≥2 g/dL (from baseline to week 1, 2, 4, or 8).~For responders, time to Hb response was defined as the scheduled time from baseline until the visit where the first Hb response was measured."|Baseline, week 1, 2, 4, and 8|ITT. All randomised subjects.|||Days||95% Confidence Interval|Median
2545507|NCT02940886|Secondary|Time to First Composite Cardiovascular Safety AE|"Safety~Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit. Only the adjudicated and confirmed composite cardiovascular safety AEs, as judged by the CEAC, were considered for this endpoint.~Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit."|Baseline, week 1, 2, 4, and 8|Safety analysis set. All randomised subjects who received at least one dose of the investigational product.|||Week||95% Confidence Interval|Median
2545508|NCT02940886|Secondary|Composite Cardiovascular Adverse Events (AEs)|"Safety~Results show the composite cardiovascular adverse events (AEs), that started on or after the first dose of randomised treatment (i.e. treatment emergent) up to week 8.~The reported potential cardiovascular AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).~The potential cardiovascular AEs included the following:~Death due to any cause~Non-fatal myocardial infarction~Non-fatal stroke~Unstable angina requiring hospitalisation~Congestive heart failure requiring hospitalisation or medical intervention~Arrhythmias~Hypertension~Hypotension~Results show only those participants that had adjudicated and confirmed treatment-emergent composite cardiovascular AEs."|Baseline, week 1, 2, and 8|Safety analysis set. All randomised subjects who received at least one dose of the investigational product.|||Participants|||Count of Participants
2545509|NCT02940886|Primary|Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions|"Safety~For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity reactions that were included in the analysis were those that started on or after the first dose of randomised treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: loss of consciousness, seizure, syncope, unresponsiveness.~The potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).~Results show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions."|Baseline to week 8|Safety analysis set. All randomised subjects who received at least one dose of the investigational product.|||Participants|||Count of Participants
2545510|NCT02940886|Primary|Change in Hemoglobin (Hb) From Baseline to Week 8|"Efficacy~Evaluate the effect on the hemoglobin (Hb) level following treatment with iron isomaltoside/ferric derisomaltose vs iron sucrose in subjects with iron deficiency anaemia (IDA) .~Response was defined as change from baseline in hemoglobin (Hb) to week 8, i.e. ability to increase Hb in subjects with IDA, when oral iron preparations were ineffective or could not be used or in whom the screening Hb measurement in Investigators' opinion were sufficiently low to require rapid repletion of iron stores."|Baseline to week 8|Intention to treat (ITT). All randomised subjects.|||g/dL||95% Confidence Interval|Least Squares Mean
2545511|NCT02940860|Secondary|Health Care Resource Use Questionnaire|"Pharmacoeconomics~Resources used by the health care staff (per administration), measured by the health care resource use questionnaire.~The questionnaire assessed the time used by the health care staff during administration of the investigational product and the administration time (including the observational time). The health care participants included in the evaluation were: investigator, pharmacist, physician, study coordinator, study nurse.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different (i.e. up to a factor 5 more frequent in the iron sucrose treatment group)."|Baseline|ITT. All randomised subjects.|||hours||Full Range|Median
2545512|NCT02940860|Secondary|Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire|"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)."|Baseline|ITT. All randomised subjects.|||Participants|||Count of Participants
2545513|NCT02940860|Secondary|Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire|"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)."|Baseline|ITT. All randomised subjects.|||Hours||Full Range|Median
2545514|NCT02940860|Secondary|Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car|"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)."|Baseline|ITT. All randomised subjects.|||miles||Full Range|Median
2545515|NCT02940860|Secondary|Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire|"Pharmacoeconomics~The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics.~The data for this endpoint show the responses at baseline for both treatment groups.~The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group)."|Baseline|ITT. All randomised subjects.|||US dollars ($)||Full Range|Median
2545639|NCT02939014|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Brentuximab Vedotin ADC||Cycles 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.|||days||Full Range|Median
2545516|NCT02940860|Secondary|Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8|"Efficacy~Change in fatigue symptoms from baseline to week 1, 2, and 8 was measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.~The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale consisted of 13 items ranging from 0 (not at all) to 4 (very much), except items #7 and #8 which are reversed scored. The total score range is 0-52.~A score of less than 30 indicated severe fatigue, and the higher the score, the better outcome/quality of life (QoL). If more than 50% of the items for a subject at a given visit were missing, the total score was not calculated.~Total score was calculated as shown below:~Total score= Sum of individual scores x 13 / Number of items answered"|Baseline, week 1, 2, and 8|ITT. All randomised subjects.|||score on a scale||Standard Deviation|Mean
2545517|NCT02940860|Secondary|Change in Concentration of S-iron From Baseline to Week 1, 2, 4, and 8|"Efficacy~Changes in the concentrations of serum iron (s-iron) from baseline to week 1, 2, 4, and 8."|Baseline, week 1, 2, 4, and 8|ITT. All randomised subjects.|||μg/dL||Standard Deviation|Mean
2545518|NCT02940860|Secondary|Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8|"Efficacy~Changes in transferrin saturation (TSAT) from baseline to week 1, 2, 4, and 8."|Baseline, week 1, 2, 4, and 8|ITT. All randomised subjects.|||percent||Standard Deviation|Mean
2545519|NCT02940860|Secondary|Change in S-ferritin From Baseline to Weeks 1, 2, 4, and 8|"Efficacy~Changes in s-ferritin from baseline to weeks 1, 2, 4, and 8."|Baseline, week 1, 2, 4, and 8|ITT. All randomised subjects.|||ng/mL||Standard Deviation|Mean
2545520|NCT02940860|Secondary|Change in Hb Concentration From Baseline to Week 1, 2, and 4|"Efficacy~Change in Hb concentration from baseline to week 1, 2, and 4."|Baseline, week 1, 2, and 4|ITT. All randomised subjects.|||g/dL||Standard Deviation|Mean
2545521|NCT02940860|Secondary|S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8|"Efficacy~Proportion of subjects reaching the composite endpoint of s-ferritin concentration ≥100 ng/mL and TSAT of 20-50% at any time from week 1 to 8."|Week 1 to week 8|ITT. All randomised subjects.|||Participants|||Count of Participants
2545522|NCT02940860|Secondary|Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8|"Efficacy~Results show the number of participants who achieved Hb concentration increase of ≥2 g/dL at any time from week 1 to week 8."|Week 1 to week 8|ITT. All randomised subjects.|||Participants|||Count of Participants
2545523|NCT02940860|Secondary|Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8|"Efficacy~Hb concentration of >12 g/dL at any time from week 1 to week 8.~Results show the number of participants who achieved Hb concentration of >12 g/dL at any time from week 1 to week 8."|Week 1 to week 8|ITT. All randomised subjects.|||Participants|||Count of Participants
2545524|NCT02940860|Secondary|Time to Change in Hb Concentration ≥1 g/dL|"Efficacy~Time to change in Hb concentration ≥1 g/dL.~Subjects who showed Hb concentration increase of ≥1 g/dL (from baseline to week 1, 2, 4, and 8).~For responders, time to Hb response was defined as the scheduled time from baseline until the visit where the first Hb response was measured."|Baseline, week 1, 2, 4, and 8|ITT. All randomised subjects.|||Days||95% Confidence Interval|Median
2545525|NCT02940860|Secondary|Hb Concentration Increase of ≥1 g/dL From Baseline to Week 1, 2, 4, and 8|"Efficacy~Results show Hb responders to the treatment. A subject was considered a Hb responder to a certain week if an increase in Hb of at least 1 g/dL from baseline to the week in question was observed (from baseline to week 1, 2, 4, and 8)."|Baseline, week 1, 2, 4, and 8|ITT. All randomised subjects.|||Participants|||Count of Participants
2545526|NCT02940860|Secondary|S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8|"Safety~Results show the number of participants who had s-phosphate <2 mg/dL at any time from baseline to week 1, 2, 4, or 8."|Baseline, week 1, 2, 4, and 8|Safety analysis set. All randomised subjects who received at least one dose of the investigational product.|||Participants|||Count of Participants
2545527|NCT02940860|Secondary|Time to First Composite Cardiovascular Safety AE|"Safety~Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit. Only the adjudicated and confirmed composite cardiovascular safety AEs, as judged by the CEAC, were considered for this endpoint.~Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit."|Baseline, week 1, 2, 4, and 8|Safety analysis set. All randomised subjects who received at least one dose of the investigational product.|||Week||95% Confidence Interval|Median
2545528|NCT02940860|Secondary|Composite Cardiovascular Adverse Events (AEs)|"Safety~Results show the composite cardiovascular AEs, that started on or after the first dose of randomised treatment (i.e. treatment emergent) up to week 8.~The reported potential cardiovascular AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).~The potential cardiovascular AEs included the following:~Death due to any cause~Non-fatal myocardial infarction~Non-fatal stroke~Unstable angina requiring hospitalisation~Congestive heart failure requiring hospitalisation or medical intervention~Arrhythmias~Hypertension~Hypotension~Results show only those participants that had adjudicated and confirmed treatment-emergent composite cardiovascular AEs."|Baseline, week 1, 2, and 8|Safety analysis set. All randomised subjects who received at least one dose of the investigational product.|||Participants|||Count of Participants
2545529|NCT02940860|Primary|Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions|"Safety~For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity reactions that were included in the analysis were those that started on or after the first dose of randomised treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: loss of consciousness, seizure, syncope, unresponsiveness.~The potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC).~Results show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions."|Baseline to week 8|Safety analysis set. All randomised subjects who received at least one dose of the investigational product.|||Participants|||Count of Participants
2550640|NCT02829944|Secondary|Number of Subjects Experiencing Pruritus|Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable|2 hours||||score on a scale||Inter-Quartile Range|Median
2545530|NCT02940860|Primary|Change in Hemoglobin (Hb) From Baseline to Week 8|"Efficacy~Evaluate the effect of iron isomaltoside/ferric derisomaltose vs iron sucrose in subjects with non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA).~Response was defined as change from baseline in hemoglobin (Hb) to week 8, i.e. ability to increase Hb in subjects with NDD-CKD and IDA, when oral iron preparations were ineffective or could not be used, or in whom the Hb measurement at screening in Investigators' opinion were sufficiently low to require rapid repletion of iron stores."|Baseline to week 8|Intention to treat (ITT). All randomised subjects.|||g/dL||95% Confidence Interval|Least Squares Mean
2545531|NCT02940691|Other Pre-specified|Sensitivity and Specificity of the Finger-stick Xpert® HCV Viral Load Assay for HCV RNA Detection|To determine the sensitivity and specificity of the Xpert® HCV Viral Load assay for HCV RNA detection in samples collected by finger-stick capillary whole-blood.|12 week post treatment|Only 22 had both Xpert and plasma samples collected. Some participants had >1 paired sample. HCV RNA from plasma was compared to the Xpert result. Sensitivity is number of positive Xpert results divided by the number of positive plasma results. The specificity is number of negative Xpert results divided by the number of negative plasma results.|||Percentage|Samples|95% Confidence Interval|Number
2545532|NCT02940691|Secondary|End of Treatment Response (Negative HCV RNA at the End of Treatment)|Number with undetectable HCV RNA at end of treatment following 12 weeks of daily Grazoprevir/Elbasvir (100mg/50mg)|12 weeks from treatment administration|Those who completed treatment|||Participants|||Count of Participants
2545533|NCT02940691|Secondary|Number of Participants With Treatment Completion|Number who completed HCV treatment as prescribed (12 weeks of grazoprevir/elbasvir (100mg/50mg) daily)|12 weeks from treatment administration|All enrolled|||Participants|||Count of Participants
2545534|NCT02940691|Primary|Undetectable HCV RNA at 12 Weeks Post End of Treatment (SVR12)|Number with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following 12 weeks of daily grazoprevir/elbasvir (100mg/50mg)|12 weeks post treatment|All enrolled|||Participants|||Count of Participants
2545535|NCT02940626|Secondary|ASN-1 and ASN-2 Terminal Elimination Half-life (t1/2) in Serum|The levels of ASN-1 and ASN-2 measured at completion of study medication infusion, and at 6 hr, 24 hr, Day 4, Day 7, Day 14, Day 22, and Day 90 after completion|through day 90|Pharmacokinetic (PK) Population: All subjects in the MITT population with at least 1 serum PK sample collected post-dose. Of the 76 subjects who received ASN100, 74 were included in the PK analysis as a result of 2 not having sufficient data. Additional reductions in the number of participants analyzed is due to missing or out of window samples.|||Hours||Standard Deviation|Mean
2545536|NCT02940626|Secondary|ASN-1 and ASN-2 Area Under the Concentration-time Curve in Serum|The levels of ASN-1 and ASN-2 measured at completion of study medication infusion, and at 6 hr, 24 hr, Day 4, Day 7, Day 14, Day 22, and Day 90 after completion|through day 90|Pharmacokinetic (PK) Population: All subjects in the MITT population with at least 1 serum PK sample collected post-dose. Of the 76 subjects who received ASN100, 74 were included in the PK analysis as a result of 2 not having sufficient data. Additional reductions in the number of participants analyzed is due to missing or out of window samples.|||μg*h/mL||Standard Deviation|Mean
2545537|NCT02940626|Secondary|ASN-1 and ASN-2 Time to Maximum Concentration (Tmax) in Serum|The levels of ASN-1 and ASN-2 measured at completion of study medication infusion, and at 6 hr, 24 hr, Day 4, Day 7, Day 14, Day 22, and Day 90 after completion|through day 90|Pharmacokinetic (PK) Population: All subjects in the MITT population with at least 1 serum PK sample collected post-dose. Of the 76 subjects who received ASN100, 74 were included in the PK analysis as a result of 2 not having sufficient data. Additional reductions in the number of participants analyzed is due to missing or out of window samples.|||Hours (from end of infusion)||Standard Deviation|Mean
2545538|NCT02940626|Secondary|ASN-1 and ASN-2 Maximum Serum Concentration (Cmax)|The levels of ASN-1 and ASN-2 measured at completion of study medication infusion, and at 6 hr, 24 hr, Day 4, Day 7, Day 14, Day 22, and Day 90 (final study visit) in subjects who are hospitalized or are able to return to the clinic for blood sampling.|through day 90|Pharmacokinetic (PK) Population: All subjects in the MITT population with at least 1 serum PK sample collected post-dose. Of the 76 subjects who received ASN100, 74 were included in the PK analysis as a result of 2 not having sufficient data. Additional reductions in the number of participants analyzed is due to missing or out of window samples.|||μg/mL||Standard Deviation|Mean
2545539|NCT02940626|Secondary|28-day All-cause Mortality|28-day all-cause mortality in the MITT Population|28 days|Modified Intent to treat (MITT): includes all subjects in the ITT Population (randomized subjects) who receive study drug and who are heavily colonized with S. aureus as determined by quantitative or semi-quantitative culture of an ETA specimen. Exclusion from the MITT Population was determined programmatically for each ITT subject.|||Participants|||Count of Participants
2545540|NCT02940626|Secondary|Length of ICU Stay|Total length of ICU stay during the first 21 days post-randomization for subjects in the MITT Population|21 days|Modified Intent to Treat (MITT): Includes all subjects in ITT Population (randomized) who received study drug and were heavily colonized with S. aureus determined by quantitative/semi-quant. culture of an ETA specimen. Exclusion from the MITT determined programmatically. Subjects not listed as being in ICU post treatment were excluded from analysis|||Days||Standard Deviation|Mean
2545541|NCT02940626|Secondary|Duration of Mechanical Ventilation|Duration of mechanical ventilation during the first 21 days post-randomization for subjects in the Modified Intent-to-Treat (MITT) Population|21 days|Modified Intent to Treat (MITT): Includes All subjects in ITT Population (randomized) who received study drug and were heavily colonized with S. aureus determined by quantitative or semi-quant. culture of an ETA specimen. Exclusion from the MITT was determined programmatically. Subjects on MV < 2 days post treatment were excluded from analysis.|||Days||Standard Deviation|Mean
2545553|NCT02940574|Primary|Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/ Reaction Time) After 4 Weeks of Nasal Spray|"Change from baseline in performance on the emotion recognition task (accuracy/ reaction time) after 4 weeks of nasal spray.~Emotion recognition from point-light displays conveying biological motion."|Value at 4 weeks minus value at baseline||||Change from baseline Acc/reaction time||Standard Deviation|Mean
2545640|NCT02939014|Secondary|Cmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE)||Cycles 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.|||ug/mL||Standard Deviation|Mean
2545542|NCT02940626|Primary|Efficacy of a Single Intravenous (IV) Dose of ASN100|Percentage of subjects in the MITT population who have or have not developed S. aureus (SA) pneumonia after a single intravenous (IV) dose of ASN100, based on sponsor defined outcome (SDO1). For each arm, the empirical proportion is defined by a ratio, which is the number of SA pneumonia events divided by the total number of subjects in the arm. The inference about the difference of two population rates is based on the empirical counterpart; specifically, the point estimate, 95% confidence interval and p-value for the rate difference. Subjects discontinued from the study due to any cause prior to Day 22 were considered as not developing SA pneumonia for the primary efficacy analysis.|Incidence of S. aureus pneumonia up to but not including Day 22|MITT: There are 2 SDO definitions. SDO1 meets either respiratory OR signs/symptoms requirements while SDO2 must meet BOTH. Individual assessments for each randomized subject were collapsed to assign a SDO1/SDO2 of Yes, No, Indeterminate (insufficient data to assign a SDO of Yes or No), or Censored (subject died prior to the Day 22 assessment).|||Participants|||Count of Participants
2545543|NCT02940574|Secondary|Change From Baseline in Scores on Questionnaire Assessing Mood After a Single Dose of Nasal Spray|"Change from baseline in scores on one questionnaire assessing mood (Profile of Mood States - POMS) after a single dose of nasal spray.~This instrument comprises emotional adjectives subdivided in five domains: tension (6 items). depression (8 items). vigor (5 items). fatigue (6 items) and anger (7 items) which have to be rated on a five-point Likert scale ranging from 0 (not at all), 1 (a little), 2 (moderately), 3 (quite a lot), to 4 (extremely). Only for the vigor scale, higher scores indicate improvement."|Value at 30 minutes minus value at baseline||||Change from base (units on a scale)||Standard Deviation|Mean
2545544|NCT02940574|Secondary|Change From Baseline in Informant-based/ Self-report Scores on Questionnaires Assessing Attachment, Social Functioning, Quality of Life and Mood After 52 Weeks, Including 48 Weeks Without Nasal Spray|"The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness.~The Repetitive Behavior Scale - Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors.~The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale.~Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents.~World Health Organization Quality of Life - Bref (WHO-QOL) uses a five-point Likert scale. Higher scores indicate better quality of life.~Profile of Mood States (POMS). five-point Likert scale."|Value at 52 weeks minus value at baseline|"Intention-to-treat~Syntocinon:~IPPA Mother, IPPA Father (n= 21) (listwise missing data: n= 1) SRS-A informant (n= 17) (missing baseline data: n= 5)~Placebo:~RBS-R, WHO-QOL (n= 17) (missing baseline data n= 1) SRS-A informant (n= 15) (missing baseline data: n= 3)"|||Change from base (units on a scale)||Standard Deviation|Mean
2545545|NCT02940574|Secondary|Change From Baseline in Informant-based/ Self-report Scores on Questionnaires Assessing Attachment, Social Functioning, Quality of Life and Mood After 8 Weeks, Including 4 Weeks Without Nasal Spray|"The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness.~The Repetitive Behavior Scale - Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors.~The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale.~Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents.~World Health Organization Quality of Life - Bref (WHO-QL) uses a five-point Likert scale. Higher scores indicate better quality of life.~Profile of Mood States (POMS). five-point Likert scale."|Value at 8 weeks minus value at baseline|"Intention-to-treat~Syntocinon:~IPPA Mother, IPPA Father (n= 21) (listwise missing data: n= 1) SRS-A informant (n= 17) (missing baseline data: n= 5)~Placebo:~RBS-R, WHO-QOL (n= 17) (missing baseline data n= 1) SRS-A informant (n= 15) (missing baseline data: n= 3)"|||Change from base (units on a scale)||Standard Deviation|Mean
2545546|NCT02940574|Secondary|Change From Baseline in Informant-based/ Self-report Scores on Questionnaires Assessing Attachment, Social Functioning, Quality of Life and Mood After 4 Weeks of Nasal Spray|"The Social Responsiveness Scale (for adults) (SRS-A) uses a four-point Likert-scale. Higher scores indicate lower social responsiveness.~The Repetitive Behavior Scale - Revised (RBS-R) uses a four-point Likert-scale. Higher scores indicate a higher frequency and/or higher severity of restricted and repetitive behaviors.~The State Adult Attachment Measure (SAAM) uses a seven-point Likert-scale.Higher scores indicate lower perceived secure attachment on the attachment avoidance and attachment anxiety subscales, and higher perceived secure attachment on the attachment security subscale.~Inventory of Parent and Peer Attachment (IPPA) uses a four-point Likert-scale. Higher scores indicate indicate increased feelings of secure attachment towards peers or parents.~World Health Organization Quality of Life - Bref (WHO-QL) uses a five-point Likert scale. Higher scores indicate better quality of life.~Profile of Mood States (POMS). five-point Likert scale."|Value at 4 weeks minus value at baseline|"Intention-to-treat~Syntocinon:~IPPA Mother, IPPA Father (n= 21) (listwise missing data: n= 1) SRS-A informant (n= 17) (missing baseline data: n= 5)~Placebo:~RBS-R, WHO-QOL (n= 17) (missing baseline data n= 1) SRS-A informant (n= 15) (missing baseline data: n= 3)"|||Change from base (units on a scale)||Standard Deviation|Mean
2545547|NCT02940574|Primary|Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray|"Change from baseline in brain connectivity during rest (resting-state fMRI) after 52 weeks, including 48 weeks without nasal spray~Amygdala connectivity (Change-from-baseline z-transformed r-value)"|Value at 52 weeks minus value at baseline||||Change-from-base z-transformed r-value||Standard Deviation|Mean
2545548|NCT02940574|Primary|Change From Baseline in Brain Connectivity During Rest (Resting-state fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray|"Change from baseline in brain connectivity during rest (resting-state fMRI) after 8 weeks, including 4 weeks without nasal spray~Amygdala connectivity (Change-from-baseline z-transformed r-value)"|Value at 8 weeks minus value at baseline||||Change-from-base z-transformed r-value||Standard Deviation|Mean
2545578|NCT02940327|Secondary|Duration on ECMO|Clinical and biochemical markers of organ failure|> 7 days or did not survive to discharge||||hours||Inter-Quartile Range|Median
2545554|NCT02940574|Primary|Change From Baseline in Performance on the Emotion Recognition Task (Accuracy/Reaction Time) After a Single Dose of Nasal Spray|Change from baseline in performance on the emotion recognition task (accuracy/reaction time) after a single dose of nasal spray Emotion recognition from point-light displays conveying biological motion.|Value at 30 minutes minus value at baseline||||Change from baseline Acc/reaction time||Standard Deviation|Mean
2545555|NCT02940574|Primary|Change From Baseline in Brain Activity During Task (Task-based fMRI) After 52 Weeks, Including 48 Weeks Without Nasal Spray|Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) after 52 weeks, including 48 weeks without nasal spray|Value at 52 weeks minus value at baseline||||Change-from-baseline Contrast estimate||Standard Deviation|Mean
2545556|NCT02940574|Primary|Change From Baseline in Brain Activity During Task (Task-based fMRI) After 8 Weeks, Including 4 Weeks Without Nasal Spray|Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) after 8 weeks, including 4 weeks without nasal spray|Value at 8 weeks minus value at baseline||||Change-from-baseline Contrast estimate||Standard Deviation|Mean
2545557|NCT02940574|Primary|Change From Baseline in Brain Activity During Task (Task-based fMRI) After 4 Weeks of Nasal Spray|Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) after 4 weeks of nasal spray|Value at 4 weeks minus value at baseline||||Change-from-baseline Contrast estimate||Standard Deviation|Mean
2545558|NCT02940574|Primary|Change From Baseline in Brain Activity During Task (Task-based fMRI) After a Single Dose of Nasal Spray|Change From Baseline in Task-related Brain Activity During Biological Motion Recognition Task (Task-based fMRI) After a Single Dose of Nasal Spray|Value at 30 minutes minus value at baseline||||Change-from-baseline Contrast estimate||Standard Deviation|Mean
2545559|NCT02940522|Secondary|Comparison of Elimination Rate Constant|Comparison of the elimination rate constant for the Primary PK Population|9 weeks|The Primary PK Population consisted of 45 subjects each for both treatments for whom whole blood was analyzed. Subjects were excluded from Treatment A and Treatment B due to insufficient number of samples for planned analyses.|||1/hr||Geometric Coefficient of Variation|Geometric Mean
2545560|NCT02940522|Secondary|Comparison of t1/2|Comparison of PK parameter t1/2 for the Primary PK Population|9 weeks|The Primary PK Population consisted of 45 subjects each for both treatments for whom whole blood was analyzed. Subjects were excluded from Treatment A and Treatment B due to insufficient number of samples for planned analyses.|||hr||Geometric Coefficient of Variation|Geometric Mean
2545561|NCT02940522|Secondary|Comparison of AUC (0-168)|Comparison of PK Parameter AUC (0-168) for the Primary PK Population|9 weeks|The Primary PK Population consisted of 45 subjects each for both treatments for whom whole blood was analyzed. Subjects were excluded from Treatment A and Treatment B due to insufficient number of samples for planned analyses.|||hr x ng/mL||Geometric Coefficient of Variation|Geometric Mean
2545562|NCT02940522|Secondary|Comparison of Tmax|Comparison of PK parameter Tmax for the Primary PK population|9 weeks|The Primary PK Population consisted of 45 subjects each for both treatments for whom whole blood was analyzed. Subjects were excluded from Treatment A and Treatment B due to insufficient number of samples for planned analyses.|||hr||Full Range|Geometric Mean
2545563|NCT02940522|Primary|Comparison of the Maximum Plasma Concentration (Cmax)|Comparison of the maximum plasma concentration (Cmax) for the Primary PK Population|9 weeks|The Primary PK Population consisted of 45 subjects each for both treatments for whom whole blood was analyzed. Subjects were excluded from Treatment A and Treatment B due to insufficient number of samples for planned analyses.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2545564|NCT02940522|Primary|Comparison of Areas Under the Curve (AUC) to the Last Time With a Concentration ≥ LLOQ [AUC0-t] and to Infinity [AUCinf]|Comparison of areas under the curve (AUC) to the last time with a concentration ≥ LLOQ [AUC0-t] and to infinity [AUCinf] for the Primary PK Population|9 weeks|The Primary PK Population consisted of 45 subjects each for both treatments for whom whole blood was analyzed. Subjects were excluded from Treatment A and Treatment B due to insufficient number of samples for planned analyses.|||hr x ng/mL||Geometric Coefficient of Variation|Geometric Mean
2545565|NCT02940327|Secondary|Change of Serum Haemoglobin Levels|Clinical and biochemical markers of organ failure|24 hours after decannulation||||g/L||Standard Deviation|Mean
2545566|NCT02940327|Secondary|Change of Serum Haemoglobin Levels|Clinical and biochemical markers of organ failure|72 hours after ECMO commencement||||g/L||Standard Deviation|Mean
2545567|NCT02940327|Secondary|Change of Serum Haemoglobin Levels|Clinical and biochemical markers of organ failure|48 hours after ECMO commencement||||g/L||Standard Deviation|Mean
2545568|NCT02940327|Secondary|Change of Serum Haemoglobin Levels|Clinical and biochemical markers of organ failure|24 hours after ECMO commencement||||g/L||Standard Deviation|Mean
2545569|NCT02940327|Secondary|Change of Serum Haemoglobin Levels|Clinical and biochemical markers of organ failure|12 hours after ECMO commencement||||g/L||Standard Deviation|Mean
2545570|NCT02940327|Secondary|Heart Injury as Determined by Serum Troponin Levels|Clinical and biochemical markers of organ failure|24 hours after decannulation||||ng/ml||Standard Deviation|Mean
2545571|NCT02940327|Secondary|Heart Injury as Determined by Serum Troponin Levels|Clinical and biochemical markers of organ failure|72 hours after ECMO commencement||||ng/ml||Standard Deviation|Mean
2545572|NCT02940327|Secondary|Heart Injury as Determined by Serum Troponin Levels|Clinical and biochemical markers of organ failure|48 hours after ECMO commencement||||ng/ml||Standard Deviation|Mean
2545573|NCT02940327|Secondary|Heart Injury as Determined by Serum Troponin Levels|Clinical and biochemical markers of organ failure|24 hours after ECMO commencement||||ng/ml||Standard Deviation|Mean
2545574|NCT02940327|Secondary|Number of Participants Requiring Non Red Cell Transfusion|Clinical and biochemical markers of organ failure|24 hours after ECMO is discontinued||||Participants|||Count of Participants
2545575|NCT02940327|Secondary|Allogenic Red Cell Transfusion Volume|Clinical and biochemical markers of organ failure|24 hours after ECMO is discontinued||||ml||Standard Deviation|Mean
2545576|NCT02940327|Secondary|Heart Injury as Determined by Serum Troponin Levels|Clinical and biochemical markers of organ failure|12 hours after ECMO commencement||||ng/ml||Standard Deviation|Mean
2545577|NCT02940327|Secondary|Number of Participants With Acute Kidney Injury|Clinical and biochemical markers of organ failure|>7 days or did not survive to discharge||||participants|||Number
2545595|NCT02939950|Primary|Number of Participants With Adverse Events|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events were defined as those events that resulted in, or had the potential to cause, either permanent impairment of an ocular function or damage to an ocular structure, and might necessitate medical or surgical intervention. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in reported AE section.|Baseline up to Month 12|Safety analysis set included all dispensed participants.|||Participants|||Count of Participants
2545596|NCT02939950|Primary|High Contrast Visual Acuity|For determination of high contrast visual acuity (VA), the participant was seated at the photoropter so that the distance from the participant's eyes to the logMAR chart was 6.5 feet (2.0 meters). The chart was at eye level for each participant. The logMAR charts had two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity was measured through the phoropter using the distance refractive correction with the addition of +0.50 Diopter to compensate for the reduced test distance of 6.5 feet (2.0 meters). A scoring sheet for each eye was provided to keep track of the letters correctly identified by the participants. Scores were recorded as the numbers of letters correctly identified in the eye examination. VA was converted to the Log10 of the Minimum Angle of Resolution (logMAR) by using the score (number of letters).|Month 12|Analysis set included all eligible dispensed participants under the treatment they actually received. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure.|||logMAR|eyes|Standard Deviation|Mean
2545597|NCT02939937|Secondary|Retinal Nerve Fibre Layer Thickness in Micrometer|Retinal nerve fibre layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography|Measured at baseline and month1 ,6|incomplete follow up|||micron||Standard Deviation|Mean
2545598|NCT02939937|Primary|Visual Field Mean Deviation in Decibel|The visual field is performed by the Swedish interactive thresholding algorithm standard 24-2 perimeter (Carl Zeiss mediated, Dublin, California).|Measured at baseline and month 6|incomplete follow up|||db||Standard Deviation|Mean
2545599|NCT02939937|Primary|Best Corrected Visual Acuity|Best corrected visual acuity is converted to logMAR (logarithms of minimum angle of resolution) by statistical calculation.|at baseline and month 6|incomplete follow up|||log mar||Standard Deviation|Mean
2545600|NCT02939937|Primary|Macular Layer Thickness|macular layer thickness measure in 8 sectors by Heidelberg spectral domain Optical Coherence Tomography|Measured at baseline and month 1, 6|incomplete follow up|||micron||Standard Deviation|Mean
2545601|NCT02939937|Primary|Retinal Ganglion Cell Inner Plexiform Layer Thickness|ganglion cell inner plexiform layer thickness measure in 8 sectors by Heidelberg spectral-domain Optical Coherence Tomography|Measured at baseline and month 1, 6|incomplete follow up from baseline to 6 month|||micron||Standard Deviation|Mean
2545602|NCT02939599|Secondary|Change From Baseline in RV Fractional Area Change at Week 16 (Day 112) Using Echocardiography|Key Right Ventricular (RV) function endpoints such as Tei Index were assessed with echocardiography. The RV Tei index is using both systolic and diastolic time intervals to evaluate the overall global dysfunction of the right ventricle in PAH patients. A lower number in RV Tei Index indicates an improvement. Only descriptive analysis performed.|16 weeks|Participants from the Pharmacodynamic (PD) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PD assessment, with data available for analysis were considered.|||Percentage change||Standard Deviation|Mean
2545603|NCT02939599|Secondary|Change From Baseline in RV Tei Index at Week 16 (Day 112) Using Echocardiography|Key Right Ventricular (RV) function endpoints such as Tei Index were assessed with echocardiography. The RV Tei index is using both systolic and diastolic time intervals to evaluate the overall global dysfunction of the right ventricle in PAH patients. A lower number in RV Tei Index indicates an improvement. Only descriptive analysis performed.|16 weeks|Participants from the Pharmacodynamic (PD) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PD assessment, with data available for analysis were considered|||Index||Standard Deviation|Mean
2545604|NCT02939599|Secondary|Change in Tricuspid Annular Peak Systolic Velocity (TA S') at Week 16 (Day 112) Using Echocardiography|Key Right Ventricular (RV) function endpoints such as Tricuspid Annular Peak Systolic Velocity (TA S') were assessed with echocardiography. Only descriptive analysis performed.|Two Years|Participants from the Pharmacodynamic (PD) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PD assessment, with data available for analysis were considered|||cm/s||Standard Deviation|Mean
2545605|NCT02939599|Secondary|Change From Baseline in Six Minute Walk Distance (6MWD)|The Six Minute Walk Test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. Only descriptive analysis performed.|16 weeks|Participants from the Pharmacodynamic (PD) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PD assessment, with data available for analysis were considered.|||Meter||Standard Deviation|Mean
2545606|NCT02939599|Secondary|Area Under the Plasma Concentration Time Curve From 0 to the End of a Dosing Interval (AUCtau)|AUCtau is the area under the plasma concentration-time curve from time zero to the end of the dosing interval. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed|16 Weeks|Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered.|||h*pg/mL||Full Range|Median
2545607|NCT02939599|Secondary|Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (AUClast)|AUClast is the area under the plasma concentration-time curve from time zero to the last measurable concentration sampling time. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed.|16 weeks|Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered|||h*pg/mL||Full Range|Median
2550641|NCT02829944|Secondary|Number of Subjects Experiencing Vomiting|Asking patients whether or not they experienced the symptom in the preceding time-frame|48 hours||||Participants|||Count of Participants
2545608|NCT02939599|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax)|Tmax is the time to reach maximum plasma concentration after single dose administration. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed.|16 Weeks|Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered.|||hour||Full Range|Median
2545609|NCT02939599|Secondary|Maximum Observed Plasma Concentration (Cmax)|Cmax is the maximum (peak) observed plasma drug concentration after single dose administration. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed|16 weeks|Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered|||pg/mL||Full Range|Median
2545610|NCT02939599|Primary|Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) in Patients With PAH Over a Two Year Period|Patients with all (serious and non-serious) adverse events, serious adverse events and death were reported|Two years|Safety set includes all participants who received at least one dose of study drug|||Participants|||Number
2545611|NCT02939560|Secondary|Change From Baseline in Functional MRI Scanning During Cognitive Processing Tasks|Functional MRI data during cognitive processing tasks|Baseline, Week 5|Unable to obtain due to lack of available equipment.||||||
2545612|NCT02939560|Primary|Change From Baseline in Repetitive Behavior Scale-Revised|Repetitive Behavior Scale-Revised Global Impression. Minimum 0, maximum 100. Higher indicates worse behaviors|Baseline, Week 5, Week 9, Week 17||||units on a scale||Standard Deviation|Mean
2545613|NCT02939560|Primary|Change From Baseline in Ritvo Autism-Aspergers Diagnostic Scale|Ritvo Autism-Aspergers Diagnostic Scale. Minimum 0, maximum 240. Higher indicates worse symptoms.|Baseline, Week 5, Week 9, Week 17||||score on a scale||Standard Deviation|Mean
2545614|NCT02939560|Primary|Change From Baseline in Social Responsiveness Scale-2|Social Responsiveness Scale-2. Minimum 0, maximum 195. Higher indicates worse behaviors|Baseline, Week 5, Week 9, Week 17||||score on a scale||Standard Deviation|Mean
2545615|NCT02939560|Primary|Change From Baseline in Aberrant Behavior Checklist|Aberrant Behavior Checklist. Minimum 0, maximum 174. Higher scores indicate worse behaviors.|Baseline, Week 5, Week 9, Week 17||||score on a scale||Standard Deviation|Mean
2545616|NCT02939560|Primary|Change From Baseline in Hamilton Depression Rating Scale|Hamilton Depression Rating Scale (HAM-D) with 17 questions. Minimum score = 0, maximum 53. Higher scores mean more severe depression.|Baseline through Week 5||||score on a scale||Standard Deviation|Mean
2545617|NCT02939326|Primary|Investigator's Assessment of GL Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS).|"Subjects Achieving a 2 Grade Response At Maximum Frown On Any Study Day By Dose using the Facial Wrinkle Scale (FWS)~The FWS is a four-point scale that indicates severity of GL as follows: 0 = none, 1 = mild, 2 = moderate, or 3 = severe.~Each scale is a four-point photonumeric scale based on photographs incorporating each aspect to be evaluated in a stepwise manner."|After single injection treatment up to 42 days|mITT|||Participants|||Count of Participants
2545618|NCT02939170|Secondary|Limbal Hyperemia|Hyperemia (excess of blood) was assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Both eyes contributed to the analysis.|Day 1 at Hour 9|Safety Analysis Set|||Eyes|Eyes||Count of Units
2545619|NCT02939170|Secondary|Ocular Staining|Assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Ocular staining was categorized by corneal staining, conjunctival staining, and limbal staining. Both eyes contributed to the analysis.|Day 1 at Hour 9|Safety Analysis Set|||Eyes|Eyes||Count of Units
2545620|NCT02939170|Primary|Incidence of Ocular Discomfort Device-related Adverse Events (AE)|"An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular discomfort device-related AE was defined as an ocular AE classified as Related to study device and deemed to be related to ocular discomfort."|Day 1 at Hour 9|Safety Analysis Set|||Events|Eyes||Number
2545621|NCT02939079|Primary|Serum Level of IFN-gamma|5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.|1 year after intervention||||Pg/ml||Standard Deviation|Mean
2545622|NCT02939079|Primary|Serum Level of IFN-gamma|5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.|6 months after intervention||||Pg/ml||Standard Deviation|Mean
2545623|NCT02939079|Primary|Serum Level of IL6|5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.|1 year after intervention||||Pg/ml||Standard Deviation|Mean
2545624|NCT02939079|Primary|Serum Level of IL6|5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.|6 months after intervention||||Pg/ml||Standard Deviation|Mean
2545641|NCT02939014|Secondary|Cmax: Maximum Observed Serum Concentration for Total Antibody (TAb)||Cycles 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.|||ug/mL||Standard Deviation|Mean
2545625|NCT02939079|Primary|Serum Level of IL1b|5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.|1 year after intervention||||Pg/ml||Standard Deviation|Mean
2545626|NCT02939079|Primary|Serum Level of IL1b|5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.|6 months after intervention||||Pg/ml||Standard Deviation|Mean
2545627|NCT02939079|Primary|Serum Level of TNF-α|5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.|1 year after intervention||||Pg/ml||Standard Deviation|Mean
2545628|NCT02939079|Primary|Serum Level of TNF-α|5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.|6 months after intervention||||Pg/ml||Standard Deviation|Mean
2545629|NCT02939079|Primary|Serum Level of IFN-gamma|5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.|Baseline||||Pg/ml||Standard Deviation|Mean
2545630|NCT02939079|Primary|Serum Level of IL6|5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.|Baseline||||Pg/ml||Standard Deviation|Mean
2545631|NCT02939079|Primary|Serum Level of IL1b|5 cc of venous blood is taken from patients and are kept in test tubes without EDTA. Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.|Baseline||||Pg/ml||Standard Deviation|Mean
2545632|NCT02939079|Primary|Serum Level of TNF-α|5 cc of venous blood is taken from patients and are kept in test tubes without ethylenediaminetetraacetic acid (EDTA). Test tubes are kept one hour immobilized so that clotted blood and serum are separated. Then, the serum is divided into four samples of 0.5 cc for immunologic testing of all primary outcomes. Immunologic testing is performed by sandwich ELISA method using Diaclone ® kits (made in France) and according to manufacturer's instructions.|Baseline|Per-protocol analysis|||Pg/ml||Standard Deviation|Mean
2545633|NCT02939014|Secondary|Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing Antitherapeutic Antibodies (nATA) to Brentuximab Vedotin|Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA development) using a laboratory test to determine ATA titers. Confirmed ATA-positive response was categorized as transient (defined as 1 or 2 post-baseline confirmed ATA-positive responses) and persistent (defined as more than 2 post-baseline confirmed ATA positive responses) and by nATA status. The number of participants in each baseline ATA and post-baseline ATA categories are reported.|Baseline, at Cycles 2, 4, 7, 10, 13, and 16 during treatment until disease progression, death or end of treatment (approximately 12 months)|Immunogenicity Population included participants who received at least 1 dose of brentuximab vedotin and had ATA status assessment at baseline, and at least 1 postbaseline sample. Number analyzed is the number of participants with data available.|||Participants|||Count of Participants
2545634|NCT02939014|Secondary|AUC(0-∞): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MMAE||Cycles 1: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.|||day*ug/mL||Standard Deviation|Mean
2545635|NCT02939014|Secondary|AUC(0-∞): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAb||Cycles 1: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.|||day*ug/mL||Standard Deviation|Mean
2545636|NCT02939014|Secondary|AUC(0-∞): Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC||Cycles 1: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|Participants from the PK-evaluable Populations, participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist, with data available for analysis.|||day*ug/mL||Standard Deviation|Mean
2545637|NCT02939014|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MMAE||Cycles 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.|||days||Full Range|Median
2545638|NCT02939014|Secondary|Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAb||Cycles 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|PK-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.|||days||Full Range|Median
2550642|NCT02829944|Secondary|Number of Subjects Experiencing Vomiting|Asking patients whether or not they experienced the symptom in the preceding time-frame|24 hours||||Participants|||Count of Participants
2545642|NCT02939014|Secondary|Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC)||Cycles 1 and 2: Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose|Pharmacokinetic (PK)-evaluable Population includes participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by the clinical pharmacologist.|||micrograms/milliliter (ug/mL)||Standard Deviation|Mean
2545643|NCT02939014|Secondary|B Symptom Resolution Rate|B Symptom Resolution Rate is defined as the percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.|Day 1 of each cycle up to 30 days after last dose of study drug (approximately 12 months)|Participants from the mITT Population, all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin, who had lymphoma-related B symptoms at baseline.|||percentage of participants||95% Confidence Interval|Number
2545644|NCT02939014|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the start of treatment to the date of death.|Up to 3.5 years|||||||
2545645|NCT02939014|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from the start of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.|Up to 3.5 years|||||||
2545646|NCT02939014|Secondary|Duration of Response (DOR)|DOR is defined as the time between the first documentation of objective tumor response (CR or PR) and the first subsequent documentation of objective tumor progression or death due to any cause, whichever occurs first. CR is defined as disappearance of all evidence of disease. PR is defined as regression of greater than or equal to 50% of measurable disease and no new sites.|Up to 3.5 years|||||||
2545647|NCT02939014|Secondary|Complete Remission (CR) Rate|CR rate is defined as the percentage of participants who have achieved CR by EOT. CR is defined as disappearance of all evidence of disease per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Baseline, at Cycles 2, 4, 7, 10, 13, and 16 during treatment, and every 12 weeks during PFS follow-up period, until disease progression death or end of treatment (approximately 12 months)|mITT Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.|||percentage of participants||95% Confidence Interval|Number
2545648|NCT02939014|Primary|Number of Participants With Abnormal Vital Signs Reported as Adverse Events|Vital signs included blood pressure in the sitting position, pulse rate, axillary temperature and weight. Abnormal vital sign values considered by the investigator to be clinically significant were recorded as Adverse Events.|First dose of study drug up to 30 days after last dose of study drug (approximately 12 months)|Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.|||Participants|||Count of Participants
2545649|NCT02939014|Primary|Number of Participants With Abnormal Clinical Laboratory Findings Reported as Adverse Events|Clinical Laboratory tests included tests of Chemistry, Hematology and Urinalysis prespecified in the protocol. Abnormal laboratory values assessed by the investigator that lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or were considered by the investigator to be clinically significant changes from Baseline were recorded as Adverse Events.|First dose of study drug up to 30 days after last dose of study drug (approximately 12 months)|Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.|||Participants|||Count of Participants
2545650|NCT02939014|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug.|First dose of study drug up to 30 days after last dose of study drug (approximately 12 months)|Safety Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.|||Participants|||Count of Participants
2545651|NCT02939014|Primary|Overall Response Rate (ORR)|ORR is defined as the percentage of participants who have achieved complete remission (CR)=disappearance of all evidence of disease or partial remission (PR)=regression of greater than or equal to 50% of measurable disease and no new site by end of treatment (EOT) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Baseline, at Cycles 2, 4, 7, 10, 13, and 16 during treatment until disease progression death or end of treatment (approximately 12 months)|Modified Intent-to-Treat (mITT) Population included all participants who had measurable lesions at baseline and received at least 1 dose of brentuximab vedotin.|||percentage of participants||95% Confidence Interval|Number
2545652|NCT02938949|Secondary|Change in Inflammatory Markers (hsCRP)|Placebo-corrected Percentage Change in Inflammatory Markers (hsCRP) From Baseline to 14 Days|baseline to 14 days||||percent change||Inter-Quartile Range|Median
2545653|NCT02938949|Secondary|Change in Inflammatory Markers (hsCRP)|Placebo-corrected percentage change in inflammatory markers (hsCRP) from baseline to 3 days|baseline to 3 days|Research team was unable to collect samples from 2 Alirocumab participants.|||percent change||Inter-Quartile Range|Median
2545654|NCT02938949|Primary|Changes in Low-density Lipoprotein (LDL) Cholesterol|Placebo-corrected percentage change in calculated LDL cholesterol from baseline to day 14|baseline and 14 days||||percent change||Inter-Quartile Range|Median
2545655|NCT02938585|Secondary|Highest Measured FVIII Activity in the Profile (Cmax)|Blood samples for the evaluation of Cmax were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. The results are based on the chromogenic assay.|Days 1-2|Full analysis set excluding outliers. The full analysis set included all dosed participants with data after dosing. Exceptional outlier PK profiles and/or individual plasma concentrations were excluded from the analysis.|||IU/mL||Standard Deviation|Mean
2545817|NCT02937558|Secondary|Percent Change in Glucose Infusion Rate (Open-Label)|The groups will be compared for mean percent change in GIR from baseline to the end of the open-label study phase.|Baseline to end of treatment at 72 hours|Evaluable subjects|||% change||Standard Deviation|Mean
2545656|NCT02938585|Secondary|Clearance (CL)|Blood samples for the evaluation of CL were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. The results are based on the chromogenic assay.|Days 1-2|Full analysis set excluding outliers. The full analysis set included all dosed participants with data after dosing. Exceptional outlier PK profiles and/or individual plasma concentrations were excluded from the analysis.|||mL/h/kg||Standard Deviation|Mean
2545657|NCT02938585|Secondary|Half-life (t½)|Blood samples for the evaluation of t½ were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. The results are based on the chromogenic assay.|Days 1-2|Full analysis set excluding outliers. The full analysis set included all dosed participants with data after dosing. Exceptional outlier PK profiles and/or individual plasma concentrations were excluded from the analysis.|||Hour (h)||Standard Deviation|Mean
2545658|NCT02938585|Secondary|Area Under the Curve (AUC0-inf)|Blood samples for the evaluation of AUC0-inf were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. AUC0-inf was defined as the area under the concentration versus time from time curve zero to infinity. The results are based on the chromogenic assay.|Days 1-2|Full analysis set excluding outliers. The full analysis set included all dosed participants with data after dosing. Exceptional outlier PK profiles and/or individual plasma concentrations were excluded from the analysis.|||IU*h/mL||Standard Deviation|Mean
2545659|NCT02938585|Secondary|Incremental Recovery of FVIII|Blood samples for the evaluation of incremental recovery of FVIII were taken during a period of 48 hours post-dosing for participants 12 years and older and 24 hours post-dosing for participants below the age of 12 years. The incremental recovery was calculated as (FVIII: coagulant (C) activity measured in plasma 30 minutes after dosing - FVIII:C activity measured in plasma immediately before dosing)/(dose injected at time 0 minute), where the dose was expressed as IU FVIII product per kg body weight. The results are based on the chromogenic assay.|Days 1-2|Full analysis set excluding outliers. The full analysis set included all dosed participants with data after dosing. Exceptional outlier pharmacokinetic (PK) profiles and/or individual plasma concentrations were excluded from the analysis.|||(IU/mL)/(IU/kg BW)||Standard Deviation|Mean
2545660|NCT02938585|Secondary|Change in Total Scores for Reported Health-related Quality of Life (for Parents): Month 24|Reported results are baseline (month 0) and change from baseline (at month 24) of end of disease and age specific health related quality of life (HRQOL). HRQOL was collected through use of the PRO instrument, HAEMO-QOL (for parents of the children (4-7 years and 8-12 years)/adolescents (13-16 years)). HAEMO-QOL assessment included questions on physical health, feeling, view of himself, family, friends, perceived support, other persons, nursery School or Kindergarten, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Observed mean of the means of all the questions for HAEMO-QOL are presented.|Month 0, Month 24|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants from both prophylaxis and on-demand regimen. “Number Analyzed” = number of participants with available data.|||Scores||Standard Deviation|Mean
2545661|NCT02938585|Secondary|Change in Total Scores for Reported Health-related Quality of Life (for Parents): Month 6|Reported results are baseline (month 0) and change from baseline (at month 6) of end of disease and age specific health related quality of life (HRQOL). HRQOL was collected through use of the PRO instrument, HAEMO-QOL (for parents of the children (4-7 years and 8-12 years)/adolescents (13-16 years)). HAEMO-QOL assessment included questions on physical health, feeling, view of himself, family, friends, perceived support, other persons, nursery School or Kindergarten, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Observed mean of the means of all the questions for HAEMO-QOL are presented.|Month 0, Month 6|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants from both prophylaxis and on-demand regimen. “Number Analyzed” = number of participants with available data.|||Scores||Standard Deviation|Mean
2545662|NCT02938585|Secondary|Change in Total Scores for Reported Health-related Quality of Life (for Participants): Month 24|Reported results are baseline (month 0) and change from baseline (at month 24) of end of disease and age specific HRQOL. HRQOL was collected through use of the patient reported outcome (PRO) instruments, HAEM-A-QOL (for adults (>=17 years)) and HAEMO-QOL (for children (8-12 years)/adolescents (13-16 years)). HAEM-A-QOL assessment included questions on physical health, feeling, view of yourself, sports and leisure, work and school, dealing with haemophilia, treatment, future, family planning, and partnership and sexuality. HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Observed mean of the means of all the questions for HAEM-A-QOL and HAEMO-QOL, respectively are presented.|Month 0, Month 24|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants from both prophylaxis and on-demand regimen. “Number Analyzed” = number of participants with available data.|||Scores||Standard Deviation|Mean
2545673|NCT02938585|Secondary|Haemostatic Effect of Turoctocog Alfa (Surgery): 6 Months|The haemostatic effect of turoctocog alfa when used for surgery was evaluated during month 0-6. The effect was assessed on a four-point scale for haemostatic response (excellent, good, moderate and none) and assessed by the investigator/surgeon on the day of surgery (day 1) and on the last day in the post-operative period the participant was at the trial/surgery site.|Month 0-6|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen.|||Surgeries|surgeries||Number
2545687|NCT02938585|Secondary|Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: Average Preventive Dose (6 Months)|Average preventive dose of turoctocog alfa consumed per participant in the prophylaxis regimen was evaluated during month 0-6.|Month 0-6|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants from the prophylaxis regimen.|||IU/kg BW|doses|Standard Deviation|Mean
2545663|NCT02938585|Secondary|Change in Total Scores for Reported Health-related Quality of Life (for Participants): Month 6|Reported results are baseline (month 0) and change from baseline (at month 6) of end of disease and age specific HRQOL. HRQOL was collected through use of the patient reported outcome (PRO) instruments, HAEMO-QOL (for children (8-12 years)/adolescents (13-16 years)) and HAEM-A-QOL (for adults (>=17 years)). HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. HAEM-A-QOL assessment included questions on physical health, feeling, view of yourself, sports and leisure, work and school, dealing with haemophilia, treatment, future, family planning, and partnership and sexuality. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Observed mean of the means of all the questions for HAEMO-QOL and HAEM-A-QOL, respectively are presented.|Month 0, Month 6|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants from both prophylaxis and on-demand regimen. “Number Analyzed” = number of participants with available data.|||Scores||Standard Deviation|Mean
2545664|NCT02938585|Secondary|Serious Adverse Events (Surgery): 24 Months|Treatment emergent serious adverse events occurred during surgery were recorded from month 0 to month 24: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant is at the trial/surgery site whatever comes first. Treatment emergent events were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.|Month 0-24|The safety analysis set included participants who received at least one dose of the trial product. “Overall Number of Participants Analyzed” = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen.|||Events|||Number
2545665|NCT02938585|Secondary|Serious Adverse Events (Surgery): 6 Months|Treatment emergent serious adverse events occurred during surgery were recorded from month 0 to month 6: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant is at the trial/surgery site whatever comes first. Treatment emergent events were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.|Month 0-6|The safety analysis set included participants who received at least one dose of the trial product. “Overall Number of Participants Analyzed” = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen.|||Events|||Number
2545666|NCT02938585|Secondary|Adverse Events (Surgery): 24 Months|TEAEs during surgery were recorded during month 0-24: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first. TEAEs were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.|Month 0-24|The safety analysis set included participants who received at least one dose of the trial product. “Overall Number of Participants Analyzed” = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen.|||Events|||Number
2545667|NCT02938585|Secondary|Adverse Events (Surgery): 6 Months|TEAEs during surgery were recorded during month 0-6: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first. TEAEs were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.|Month 0-6|The safety analysis set included participants who received at least one dose of the trial product. “Overall Number of Participants Analyzed” = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen.|||Events|||Number
2545668|NCT02938585|Secondary|Requirements for Transfusion (Surgery): 24 Months|Surgeries required transfusion was evaluated during month 0-24: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first.|Month 0-24|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen.|||Surgeries|surgeries||Number
2545669|NCT02938585|Secondary|Requirements for Transfusion (Surgery): 6 Months|Surgeries required transfusion was evaluated during month 0-6: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first.|Month 0-6|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen.|||Surgeries|surgeries||Number
2545670|NCT02938585|Secondary|Loss of Blood (Surgery): 24 Months|Loss of blood was evaluated during month 0-24: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first.|Month 0-24|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen. “Overall Number of Units Analyzed” = number of surgeries where blood loss happened.|||mL|surgeries with blood loss|Standard Deviation|Mean
2545671|NCT02938585|Secondary|Loss of Blood (Surgery): 6 Months|Loss of blood was evaluated during month 0-6: on the day of surgery (day 1) and during the post-operative period days 2-7 or until the last day the participant was at the trial/surgery site whatever comes first.|Month 0-6|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen. “Overall Number of Units Analyzed” = number of surgeries where blood loss happened.|||mL|surgeries with blood loss|Standard Deviation|Mean
2545672|NCT02938585|Secondary|Haemostatic Effect of Turoctocog Alfa (Surgery): 24 Months|The haemostatic effect of turoctocog alfa when used for surgery was evaluated during month 0-24. The effect was assessed on a four-point scale for haemostatic response (excellent, good, moderate and none) and assessed by the investigator/surgeon on the day of surgery (day 1) and on the last day in the post-operative period the participant was at the trial/surgery site. Haemostatic response of 'not applicable' indicated that turoctocog alfa was not used.|Month 0-24|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants who underwent surgeries, from both prophylaxis and on-demand regimen.|||Surgeries|surgeries||Number
2545674|NCT02938585|Secondary|Frequency of Serious Adverse Events (24 Months)|Frequency of serious adverse events (SAEs) are presented as rate of events, which was calculated as the number of SAEs per patient years. All presented SAEs are treatment emergent, which were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.|Month 0-24|The safety analysis set included participants who received at least one dose of the trial product. “Overall Number of Participants Analyzed” = number of participants from both prophylaxis and on-demand regimen.|||Events per person-year|||Number
2545675|NCT02938585|Secondary|Frequency of Serious Adverse Events (6 Months)|Frequency of serious adverse events (SAEs) are presented as rate of events, which was calculated as the number of SAEs per patient years. All presented SAEs are treatment emergent, which were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.|Month 0-6|The safety analysis set included participants who received at least one dose of the trial product. “Overall Number of Participants Analyzed” = number of participants from both prophylaxis and on-demand regimen.|||Events per person-year|||Number
2545676|NCT02938585|Secondary|Frequency of Adverse Events (24 Months)|Frequency of adverse events (AEs) are presented as rate of events, which was calculated as the number of AEs per patient years. All presented AEs are treatment emergent (TEAEs), which were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.|Month 0-24|The safety analysis set included participants who received at least one dose of the trial product. “Overall Number of Participants Analyzed” = number of participants from both prophylaxis and on-demand regimen.|||Events per person-year|||Number
2545677|NCT02938585|Secondary|Frequency of Adverse Events (6 Months)|Frequency of adverse events (AEs) are presented as rate of events, which was calculated as the number of AEs per patient years. All presented AEs are treatment emergent (TEAEs), which were defined as the events reported after trial product administration until the end of the post-treatment follow-up period.|Month 0-6|The safety analysis set included participants who received at least one dose of the trial product. “Overall Number of Participants Analyzed” = number of participants from both prophylaxis and on-demand regimen.|||Events per person-year|||Number
2545678|NCT02938585|Secondary|Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Year (24 Months)|Total consumption of turoctocog alfa (IU/kg body weight per year) per participant in both prophylaxis and on-demand regimen was evaluated during month 0-24.|Month 0-24|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants from both prophylaxis and on-demand regimen.|||IU/kg BW/year/participant||Standard Deviation|Mean
2545679|NCT02938585|Secondary|Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Year (6 Months)|Total consumption of turoctocog alfa (IU/kg body weight per year) per participant in both prophylaxis and on-demand regimen was evaluated during month 0-6.|Month 0-6|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants from both prophylaxis and on-demand regimen.|||IU/kg BW/year/participant||Standard Deviation|Mean
2545680|NCT02938585|Secondary|Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Month (24 Months)|Total consumption of turoctocog alfa (IU/kg body weight per month) per participant in both prophylaxis and on-demand regimen was evaluated during month 0-24.|Month 0-24|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants from both prophylaxis and on-demand regimen.|||IU/kg BW/month/participant||Standard Deviation|Mean
2545681|NCT02938585|Secondary|Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Month (6 Months)|Total consumption of turoctocog alfa (IU/kg body weight per month) per participant in both prophylaxis and on-demand regimen was evaluated during month 0-6.|Month 0-6|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants from both prophylaxis and on-demand regimen.|||IU/kg BW/month/participant||Standard Deviation|Mean
2545682|NCT02938585|Secondary|Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Year (24 Months)|Preventive dose of turoctocog alfa (IU/kg body weight (BW) per year) per participant in the prophylaxis regimen was evaluated during month 0-24.|Month 0-24|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants from the prophylaxis regimen.|||IU/kg BW/year/participant||Standard Deviation|Mean
2545683|NCT02938585|Secondary|Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Year (6 Months)|Preventive dose of turoctocog alfa (IU/kg body weight per year) per participant in the prophylaxis regimen was evaluated during month 0-6.|Month 0-6|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants from the prophylaxis regimen.|||IU/kg BW/year/participant||Standard Deviation|Mean
2545684|NCT02938585|Secondary|Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Month (24 Months)|Preventive dose of turoctocog alfa (IU/kg body weight (BW) per month) per participant in the prophylaxis regimen was evaluated during month 0-24.|Month 0-24|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants from the prophylaxis regimen.|||IU/kg BW/month/participant||Standard Deviation|Mean
2545685|NCT02938585|Secondary|Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Month (6 Months)|Preventive dose of turoctocog alfa (IU/kg body weight (BW) per month) per participant in the prophylaxis regimen was evaluated during month 0-6.|Month 0-6|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants from the prophylaxis regimen.|||IU/kg BW/month/participant||Standard Deviation|Mean
2545686|NCT02938585|Secondary|Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: Average Preventive Dose (24 Months)|Average preventive dose of turoctocog alfa consumed per participant in the prophylaxis regimen was evaluated during month 0-24.|Month 0-24|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants from the prophylaxis regimen.|||IU/kg BW|doses|Standard Deviation|Mean
2549213|NCT02858362|Secondary|Change From Baseline in Peak Cough Flow (PCF)|Analysis of PCF was planned for Cohort 3 only.|Baseline, Week 12, Week 24, Week 36 and Week 48|No evaluable data was collected from Cohort 3 participants due to early study termination.||||||
2545688|NCT02938585|Secondary|Consumption of Turoctocog Alfa for Bleeding Treatment: IU/kg Per Bleed (24 Months)|Consumption of turoctocog alfa IU/kg BW per bleed in both prophylaxis and on-demand regimen was evaluated during month 0-24.|Month 0-24|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen.|||IU/kg BW|bleeding episodes|Standard Deviation|Mean
2545689|NCT02938585|Secondary|Consumption of Turoctocog Alfa for Bleeding Treatment: IU/kg Per Bleed (6 Months)|Consumption of turoctocog alfa IU/kg BW per bleed in both prophylaxis and on-demand regimen was evaluated during month 0-6.|Month 0-6|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen.|||IU/kg BW|bleeding episodes|Standard Deviation|Mean
2545690|NCT02938585|Secondary|Consumption of Turoctocog Alfa for Bleeding Treatment: Number of Injections Per Bleed (24 Months)|Number of turoctocog alfa injections consumed to treat a bleeding episode in both prophylaxis and on-demand regimen was evaluated during month 0-24.|Month 0-24|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen.|||Injections|bleeding episodes|Standard Deviation|Mean
2545691|NCT02938585|Secondary|Consumption of Turoctocog Alfa for Bleeding Treatment: Number of Injections Per Bleed (6 Months)|Number of turoctocog alfa injections consumed to treat a bleeding episode in both prophylaxis and on-demand regimen was evaluated during month 0-6.|Month 0-6|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen.|||Injections|bleeding episodes|Standard Deviation|Mean
2545692|NCT02938585|Secondary|Consumption of Turoctocog Alfa for Bleeding Treatment: Average Dose to Treat a Bleed (24 Months)|Average dose of turoctocog alfa used to treat a bleed in both prophylaxis and on-demand regimen was evaluated during month 0-24.|Month 0-24|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen.|||IU/kg BW|doses|Standard Deviation|Mean
2545693|NCT02938585|Secondary|Consumption of Turoctocog Alfa for Bleeding Treatment: Average Dose to Treat a Bleed (6 Months)|Average dose of turoctocog alfa used to treat a bleed in both prophylaxis and on-demand regimen was evaluated during month 0-6.|Month 0-6|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen.|||IU/kg BW|doses|Standard Deviation|Mean
2545694|NCT02938585|Secondary|Number of Bleeds (Total Bleeds Assessed as Annual Bleeding Rate) Per Participant: 24 Months|Number of bleeds (total bleeds assessed as annual bleeding rate) per participant in the prophylaxis regimen was evaluated during month 0-24. The annualised bleeding rate was analysed by a negative binomial model.|Month 0-24|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants from the prophylaxis regimen.|||Bleeding episodes/year||95% Confidence Interval|Number
2545695|NCT02938585|Secondary|Number of Bleeds (Total Bleeds Assessed as Annual Bleeding Rate) Per Participant: 6 Months|Number of bleeds (total bleeds assessed as annual bleeding rate) per participant in the prophylaxis regimen was evaluated during month 0-6. The annualised bleeding rate was analysed by a negative binomial model.|Month 0-6|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants from the prophylaxis regimen.|||Bleeding episodes/year||95% Confidence Interval|Number
2545696|NCT02938585|Secondary|Incidence Rate of Inhibitory Antibodies Against FVIII (≥0.6 BU): 24 Months|This endpoint presented 'percentage of participants with inhibitory antibodies against FVIII (≥0.6 BU)' in both prophylaxis and on-demand regimen, evaluated during month 0-24.|Month 0-24|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants, from both prophylaxis and on-demand regimen.|||Percentage of participants|||Number
2545697|NCT02938585|Secondary|Incidence Rate of Inhibitory Antibodies Against FVIII (≥0.6 BU): 6 Months|This endpoint presented 'percentage of participants with inhibitory antibodies against FVIII (≥0.6 BU)' in both prophylaxis and on-demand regimen, evaluated during month 0-6.|Month 0-6|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants, from both prophylaxis and on-demand regimen.|||Percentage of participants|||Number
2545698|NCT02938585|Secondary|Haemostatic Effect of Turoctocog Alfa (Treatment of Bleeds): 24 Months|The haemostatic effect of turoctocog alfa when used for treatment of bleeding episodes in both prophylaxis and on-demand regimen was evaluated during month 0-24. The effect was assessed on a four-point scale for haemostatic response, excellent, good, moderate and none.|Month 0-24|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen.|||Bleeding episodes|Bleeding episodes||Number
2545699|NCT02938585|Primary|Haemostatic Effect of Turoctocog Alfa (Treatment of Bleeds): 6 Months|The haemostatic effect of turoctocog alfa when used for treatment of bleeding episodes in both prophylaxis and on-demand regimen was evaluated during month 0-6. The effect was assessed on a four-point scale for haemostatic response, excellent, good, moderate and none.|Month 0-6|The full analysis set included all dosed participants with data after dosing. “Overall Number of Participants Analyzed” = number of participants with bleeding episodes, from both prophylaxis and on-demand regimen.|||Bleeding episodes|Bleeding episodes||Number
2545700|NCT02938520|Secondary|Change From 4b in Tolerability of Injection at Weeks 5, 40 and 41 Using Numeric Rating Scale (NRS) Within CAB LA+RPV LA Arm|The NRS questionnaire is used to assess the tolerability of injections in CAB LA+RPV LA arm only. The questionnaire consists of one single question and will assess maximum level of pain experienced with the most recent injections ranking from no pain (0) to extreme pain (10). Missing scores was imputed using LOCF.|Weeks 4b, 5, 40 and 41|ITT-E Population. Only those participants with data available at the specified data points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2545701|NCT02938520|Secondary|"Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using General Acceptance Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire"|ACCEPT questionnaire is generic medication acceptance measure assessing how participants weigh advantages and disadvantages of long-term medication. It consists 25 items, capturing six dimensions. 3 questions focusing on general acceptance of study medication were analyzed. Items scores are rated as 1-5 :1-totally disagree,2-somewhat disagree,3-somewhat agree,4-totally agree and 5-I don't know. The acceptance domain score (ranging from 0 to 100) is calculated using the following formula:100*(mean of recoded items in dimension minus 1) divided by 2.LOCF was primary method of analysis. Measure type is mean for adjusted mean and dispersion measure: 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.|Baseline and at Weeks 8, 24 and 48|ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||95% Confidence Interval|Mean
2545702|NCT02938520|Secondary|Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44|HIVTSQs (status version) is a 12 item questionnaire. The individual item scores are ratedas 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater treatment satisfaction as compared to the past few weeks. LOCF was used as primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline and at Weeks 4b, 24 and 44|ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2545703|NCT02938520|Secondary|Change in Treatment Satisfaction Over Time Using HIVTSQc at Week 48|HIVTSQc (change version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range:-33 to 33. Higher scores represent greater improvement in treatment satisfaction compared to satisfaction with treatment received during the induction phase; lower scores representedeterioration in satisfaction with treatment. A score of 0 represents no change. LOCF was primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.|Week 48|ITT-E Population. Only those participants with data available at the specified data points were analyzed|||Scores on a scale||Standard Error|Mean
2545704|NCT02938520|Secondary|Change From Baseline in Total Treatment Satisfaction Using HIV Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4b, 24 and 44|HIVTSQs (status version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment. A score of 0 represents no change. LOCF was primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. Adjusted mean and 95% CI of adjusted mean values has been presented.|Baseline and at Weeks 4b, 24 and 44|ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||95% Confidence Interval|Mean
2545705|NCT02938520|Secondary|Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12)|The SF-12 questionnaire consists of 7 questions which measures degree of general health status and mental health distress. Each question is scored 0-5, except for question 2 scored 0-3. HRQoL using SF-12 for physical component summary (PCS) and mental component summary (MCS) were assessed for two treatment groups.Missing component scores was imputed using LOCF.PCS/MCS are calculated using computer software purchased from QualityMetric (http://www.qualitymetric.com).The higher the score, the better will be the health status.Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.|Baseline and at Weeks 24 and 48|ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||95% Confidence Interval|Mean
2545706|NCT02938520|Secondary|Change From Baseline in DISWO Using HATQoL|The HATQoL questionnaire was used to assess HRQoL. It comprises of three dimensions: LISAT, MEDWO and DISWO. For the DISWO domain, each question is scored as 1-5, where 5 is associated with disclosure worry 'none of the time' and 1 as 'all of the time'. The total score for the DISWO domain (sum of item scores for questions 3a to 3e) is transformed to a 0-100 scale using formula: [100 divided by (25 minus 5)]* (raw total score for DISWO minus 5). Higher DISWO total scores correspond to lower disclosure worries. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.|Baseline and at Weeks 24 and 48|ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||95% Confidence Interval|Mean
2545707|NCT02938520|Secondary|Change From Baseline in HIV Medication, MEDWO Using HATQoL|The HATQoL questionnaire was used to assess HRQoL. It comprises of three dimensions: LISAT, MEDWO and DISWO. For the MEDWO domain, each question is scored as 1-5, where 5 is associated with medication worry 'none of the time' and 1 as 'all of the time'. The total score for the MEDWO domain (sum of item scores for questions 2a to 3e) is transformed to a 0-100 scale using formula: [100 divided by (25 minus 5)]* (raw total score for MEDWO minus 5). Higher MEDWO scores correspond to lower medication worries. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.|Baseline and at Weeks 24 and 48|ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||95% Confidence Interval|Mean
2545708|NCT02938520|Secondary|Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire|The HATQoL questionnaire was used to assess health related QoL (HRQoL). It comprises of three dimensions: life satisfaction (LISAT), medication worries (MEDWO) and disclosure worries (DISWO). For LISAT domain, each question is scored as 1-5, where 5 corresponds to satisfaction 'all of time' and 1 as 'none of time'. Total score for the LISAT domain (sum of item scores for questions 1a to 1d) is transformed to a 0-100 scale using formula:[100 divided by (20 minus 4)]*(raw total score for LISAT minus 4). Higher the LISAT score, greater satisfaction to life. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.|Baseline (Day 1) and at Weeks 24 and 48|ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||95% Confidence Interval|Mean
2545709|NCT02938520|Secondary|Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire|PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR),anxiety before and after injection, willingness to receive HIV injectable treatment, following visit and satisfaction with mode of treatment administration of individuals receiving injection and perceptions associated with receiving injections.This measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1:most favorable perception of vaccination, and 5:most unfavorable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.Score of a domain is calculated as mean of all items with domain.Higher scores represent worse perception of injection.LOCF was primary method of analysis.|Weeks 5, 41 and 48|ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percentage of participants|||Number
2545710|NCT02938520|Secondary|Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF)|PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR),anxiety before and after injection, willingness to receive HIV injectable treatment and satisfaction with mode of treatment administration of individuals receiving injection and perceptions associated with receiving injections.This measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1:most favorable perception of vaccination, and 5:most unfavorable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.Score of a domain is calculated as mean of all items with domain.Higher scores represent worse perception of injection.LOCF was primary method of analysis|Weeks 5 and at Weeks 41 and 48|ITT-E Population. Only those participants with data available at the specified data points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2545711|NCT02938520|Other Pre-specified|Number of Participants With Different Demographic Parameters for Inter-subject Variability|Blood samples were planned to be collected at indicated time points for PK analysis of CAB LA and RPV LA. Demographic parameters including, but not limited to, age, sex, race, body weight, body mass index, and relevant laboratory parameters were planned to be evaluated as potential predictors of inter subject variability for pharmacokinetic parameters.|Up to Week 48|PK Population. This was an exploratory Outcome Measure. Data will not be analyzed and reported.||||||
2545712|NCT02938520|Secondary|Cmax in Plasma for RPV LA Evaluable at Week 41|Blood samples will be collected at indicated time points for PK analysis of RPV LA.|Week 41- 1 Week post dose|PK Population. Only those participants with data available at the specified data points were analyzed.|||Nanograms per milliliter||95% Confidence Interval|Geometric Mean
2545713|NCT02938520|Secondary|Maximum Concentration (Cmax) in Plasma for CAB LA Evaluable at Week 41|Blood samples will be collected at indicated time points for PK analysis of CAB LA.|Week 41- 1 Week post dose|PK Population. Only those participants with data available at the specified data points were analyzed.|||Micrograms per milliliter||95% Confidence Interval|Geometric Mean
2545714|NCT02938520|Secondary|Ctrough for RPV LA Evaluable|Blood samples were collected at indicated time points for PK analysis of RPV LA.|Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Nanograms per milliliter||95% Confidence Interval|Geometric Mean
2545715|NCT02938520|Secondary|Plasma Trough Concentration (Ctrough) for CAB LA Evaluable|Blood samples were collected at indicated time points for PK analysis of CAB LA.|Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|PK population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Microgram per milliliter||95% Confidence Interval|Geometric Mean
2545716|NCT02938520|Secondary|AUC for RPV LA|AUC values are Bayesian PK parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201584 and 201585# NCT02951052. Blood samples from the current study 201584 were collected at indicated time points to analyse concentration in plasma for RPV LA|Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5, 41, 2 hours post-dose at Weeks 4 and 48|PK Population.|||Hours*nanograms per milliliter||95% Confidence Interval|Geometric Mean
2545717|NCT02938520|Secondary|Area Under the Curve (AUC) for CAB LA|AUC values are Bayesian pharmacokinetic (PK) parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201584 and 201585# NCT02951052. Blood samples from the current study 201584 were collected at indicated time points to analyse concentration in plasma for CAB LA. The PK Population includes all participants who received CAB and / or RPV and undergo PK sampling during the study, and provide CAB and /or RPV plasma concentration data.|Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5, 41, 2 hours post-dose at Weeks 4 and 48|PK Population.|||Hours*micrograms per milliliter||95% Confidence Interval|Geometric Mean
2545839|NCT02935894|Secondary|Change in Sweat Ibuprofen Concentrations|Sweat concentration of ibuprofen prior to and 30 min, 2 hr and 4 hr after oral administration|measured at four timepoints at study visit 4|Of the 14 subjects recruited for this study, only 9 provided usable data for this primary outcome.|||micrograms per milliliter||Full Range|Geometric Mean
2545718|NCT02938520|Secondary|Number of Participants With Genotypic Resistance Through Week 48|Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. Genotypic Resistance data for the following drugs: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented.|Week 48|CVF Population. Only those participants with data available at the specified data points were analyzed.|||Participants|||Count of Participants
2545719|NCT02938520|Secondary|Number of Participants With Phenotypic Resistance Through Week 48|Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. Phenotypic Resistance data for following drugs :CAB,dolutegravir(DTG),elvitegravir (EVG), raltegravir(RAL),delavirdine(DLV),efavirenz(EFV),etravirine(ETR),nevirapine(NVP),RPV,lamivudine(3TC),abacavir(ABC),emtricitabine(FTC),tenofovir(TDF),zidovudine(ZDV),stavudine(d4T),didanosine(ddI),atazanavir(ATV),darunavir(DRV),fosamprenavir(FPV),indinavir(IDV),lopinavir(LPV),nelfinavir(NFV),ritonavir(RTV), saquinavir(SQV) and tipranavir (TPV) in participants meeting CVF criteria is presented.Phenotypic resistance, partially sensitive, and Sensitive were defined based on fold change(FC) value from Monogram as:resistance (FC>clinical higher cutoff/biologic cutoff),partially sensitive (FC=clinical higher cutoff and > clinical lower cutoff),sensitive(FC<=clinical lower cutoff/biologic cutoff). The CVF population comprised of all participants in ITT-E population who met CVF criteria|Week 48|CVF Population. Only those participants with data available at the specified data points were analyzed.|||Participants|||Count of Participants
2545720|NCT02938520|Secondary|Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48|Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Baseline value is defined as the last available recorded fasting value up to and including the date of first Maintenance Phase dose of IP. Percentage change from baseline is calculated as: value at Week 48 (if collected while fasting) minus Baseline value divided by Baseline value multiplied by 100.|Baseline (Day 1) and at Week 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2545721|NCT02938520|Secondary|Number of Participants Who Discontinued or Withdrawn Due to AEs Over Time Including Week 48|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. All Maintenance Phase adverse events (start date occurring on or after the date of first dose of randomized study treatment) leading to withdrawal have been presented.|Up to Week 48|Safety Population.|||Participants|||Count of Participants
2545722|NCT02938520|Secondary|Change From Baseline Values in Urine pH Over Time Including Week 48|Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 24 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||pH||Standard Deviation|Mean
2545723|NCT02938520|Secondary|Change From Baseline Values in Urine Specific Gravity Over Time Including Week 48|Urine biomarker samples were collected for the analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. The urine specific gravity was measured as the ratio of urine density compared with water density.|Baseline (Day 1) and at Weeks 4, 24 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Ratio of urine density to water density||Standard Deviation|Mean
2545724|NCT02938520|Secondary|Change From Baseline Values in Urine Retinol Binding Protein Over Time Including Week 48|Urine biomarker samples were collected for the analysis of urine retinol binding protein. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Week 48|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Nanomoles per liter||Standard Deviation|Mean
2545725|NCT02938520|Secondary|Change From Baseline Values in Urine Phosphate Over Time Including Week 48|Urine biomarker samples were collected for the analysis of urine phosphate. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 24 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2545726|NCT02938520|Secondary|Change From Baseline Values in Urine Creatinine Over Time Including Week 48|Urine biomarker samples were collected for the analysis of urine creatinine. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 24 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2545727|NCT02938520|Secondary|Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48|Urine biomarker samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 24 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Grams per mole||Standard Deviation|Mean
2545728|NCT02938520|Secondary|Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48|Blood samples were collected at Baseline and at Week 48 to assess glucose and fasting lipids which included total cholesterol, high density lipoprotein (HDL)cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. Only fasting data is presented for glucose and lipids. Baseline value is defined as the last available fasting recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at Week 48 visit (if collected while fasting) minus the Baseline value.|Baseline (Day 1) and at Week 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2545729|NCT02938520|Secondary|Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance|Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance. GFR will be estimated by the central laboratory using the CKD-EPI. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||mL/min/1.73/m^2||Standard Deviation|Mean
2545730|NCT02938520|Secondary|Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase|Blood samples were collected for the analysis of clinical chemistry parameter-lipase. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Units per liter||Standard Deviation|Mean
2545731|NCT02938520|Secondary|Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48|Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2545732|NCT02938520|Secondary|Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine|Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2545733|NCT02938520|Secondary|Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin|Blood samples were collected for the analysis of clinical chemistry parameter-albumin. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2545734|NCT02938520|Secondary|Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK|Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK. Baseline values is defined as the latest pre-treatment assessment with a non-missing value. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||International units per liter||Standard Deviation|Mean
2545735|NCT02938520|Secondary|Change From Baseline for Hematology Parameters: Hemoglobin|Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2545736|NCT02938520|Secondary|Change From Baseline for Hematology Parameters: Hematocrit|Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Proportion of red blood cells in blood||Standard Deviation|Mean
2545760|NCT02938520|Secondary|Absolute Values for Plasma HIV-1 RNA at Week 48|Plasma for quantitative HIV-1 RNA were collected at indicated time points. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented.|Week 48|ITT-E Population. Only those participants with data available at the specified data points were analyzed|||log10 copies/mL||Standard Deviation|Mean
2545737|NCT02938520|Secondary|Change From Baseline for Hematology Parameters: Erythrocytes|Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||10^12 cells per Liter||Standard Deviation|Mean
2545738|NCT02938520|Secondary|Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume|Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Femtoliters||Standard Deviation|Mean
2545739|NCT02938520|Secondary|Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets|Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||10^9 cells per Liter||Standard Deviation|Mean
2545740|NCT02938520|Secondary|Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48|Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).|Baseline (Day 1) and at Weeks 4, 24 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2545741|NCT02938520|Secondary|Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48|The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters (ketones, glucose, bilirubin, occult blood, nitrite and blood protein) can be read as positive, trace, 1+, 2+, 3+ and 4+ indicating proportional concentrations in the urine sample. The urine parameters were graded according to DAIDS scale where Grade 1 indicates mild (trace to 1+), Grade 2 indicates moderate (2+) and Grade 3 indicates severe (3+ or higher). Only participants with abnormal findings for urinalysis at any visit has been presented.|Baseline (Day 1) and at Weeks 4, 24 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2545742|NCT02938520|Secondary|Absolute Values for Fasting Lipid Panel Overtime Including Week 48|Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, high density lipoprotein (HDL)cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides.|Baseline (Day 1) and at Week 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2545743|NCT02938520|Secondary|Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance.|Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance at indicated timepoints. Glomerular filtration rate (GFR) will be estimated by the central laboratory using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||mL/min/1.73/m^2||Standard Deviation|Mean
2545744|NCT02938520|Secondary|Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase|Blood samples were collected for the analysis of clinical chemistry parameter-lipase at indicated timepoints.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Units per liter||Standard Deviation|Mean
2545745|NCT02938520|Secondary|Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48|Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea at indicated timepoints.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2545746|NCT02938520|Secondary|Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine|Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin at indicated timepoints.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2545747|NCT02938520|Secondary|Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin|Blood samples were collected for the analysis of clinical chemistry parameter-albumin at indicated timepoints.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2548981|NCT02863263|Secondary|Number of Patients Achieving Early Study Completion Due to Complete Healing|Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration.|12 weeks||||Participants|||Count of Participants
2545748|NCT02938520|Secondary|Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK)|Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated timepoints.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||International units per liter||Standard Deviation|Mean
2545749|NCT02938520|Secondary|Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit|Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Proportion of red blood cells in blood||Standard Deviation|Mean
2545750|NCT02938520|Secondary|Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin|Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2545751|NCT02938520|Secondary|Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes|Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||10^12 cells per Liter||Standard Deviation|Mean
2545752|NCT02938520|Secondary|Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume|Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Femtoliters||Standard Deviation|Mean
2545753|NCT02938520|Secondary|Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets|Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated time points.|Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||10^9 cells per Liter||Standard Deviation|Mean
2545754|NCT02938520|Secondary|Number of Participants With Severity of Adverse Events|Severity of adverse events (AEs) were defined as per The Division of acquired immuno deficiency syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 2.0, November 2014. Severity grades for AEs were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 were all deaths related to an AE. All Maintenance Phase adverse events have been presented, which includes AEs with start date occuring on or after the date of first dose of randomized study treatment, up to and including the start date of LTFU antiretroviral therapy for participants who discontinued from the Q4W arm.|Up to Week 48|Safety Population|||Participants|||Count of Participants
2545755|NCT02938520|Secondary|Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment. Safety Population: all randomized participants who received at least 1 dose of IP during maintenance phase and assessed according to actual treatment received. All Maintenance Phase AEs was presented including AEs with start date occurring on/after date of 1st dose of randomized treatment, up to and including start date of LTFU antiretroviral therapy for participants who discontinued from Q4W arm. Non-SAE counts in >=5% of participants within any arm is reported|Day 1 up to an average of 59 Weeks|Safety Population|||Participants|||Count of Participants
2545756|NCT02938520|Secondary|Number of Participants With Disease Progression|Data for participants who experienced disease progression to Centers for Disease Control and Prevention (CDC) Stage III or death has been presented. CDC stage is derived according to lowest post baseline CD4+ T-lympohocyte count and/or occurrence of AIDS-defining conditons (per 2014 CDC criteria).|Day 1 up to an average of 59 weeks|ITT-E Population|||Participants|||Count of Participants
2545757|NCT02938520|Secondary|Change From Baseline Values for CD4+ Lymphocyte Count at Week 48|Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to ABC/DTG/3TC. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as post-dose visit value at Week 48 minus Maintenance Baseline value.|Baseline (Day 1) and Week 48|ITT-E Population. Only those participants with data available at the specified data points were analyzed|||Cells per cubic millimeter||Standard Deviation|Mean
2545758|NCT02938520|Secondary|Absolute Values for CD4+ Lymphocyte Count at Week 48|Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to ABC/DTG/3TC|Week 48|ITT-E Population. Only those participants with data available at the specified data points were analyzed|||Cells per cubic millimeter||Standard Deviation|Mean
2545759|NCT02938520|Secondary|Change From Baseline Values for Plasma HIV-1 RNA at Week 48|Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as: HIV-1 RNA(log 10) at Week 48 minus HIV-1 RNA(log 10) at Baseline.|Baseline (Day 1) and at Week 48|ITT-E Population. Only those participants with data available at the specified data points were analyzed|||log10 copies/mL||Standard Deviation|Mean
2545762|NCT02938520|Secondary|Number of Participants With HIV-1 RNA <200 Copies/mL Using Snapshot Algorithm at Week 48|Percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 48 using the snapshot algorithm was assessed based on the antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC|Week 48|ITT-E Population|||Percentage of Participants||95% Confidence Interval|Number
2545763|NCT02938520|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL Using Snapshot Algorithm at Week 48|Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 using FDA snapshot algorithm was assessed to demonstrate antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC. The HIV-1 RNA <50 copies/mL per snapshot algorithm was determined by last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window (+/- 6 weeks). Participants with no data in the analysis window were classificated as non-responders.|Week 48|ITT-E Population|||Percentage of Participants|||Number
2545764|NCT02938520|Primary|Percentage of Participants With Virologic Failure (HIV-1 Ribonucleic Acid [RNA] >=50 Copies Per Millilter [mL]) Using Snapshot Algorithm at Week 48|Percentage of participants with virologic failure endpoint (HIV-1 RNA>=50 c/mL) as per Food and Drug Administration (FDA) snapshot algorithm at Week 48 was assessed to demonstrate the noninferior antiviral activity of switching to intramuscular (IM) CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC regimen over 48 weeks in HIV-1 infected ARTexperienced participants. The HIV-1 RNA >=50 copies/mL per snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window (+/- 6 weeks) or at time of discontinuation (if discontinuation occurred prior to Week 48 for reasons other than Adverse Event).|Week 48|Intent-to treat exposed (ITT-E) participants included all randomized participants who received at least one dose of Investigational Product (IP) during the Maintenance Phase. Participants were analyzed according to the randomized treatment regardless of what treatment actually received.|||Percentage of Participants|||Number
2545765|NCT02938052|Secondary|Immediate Impact of the Exercises: Positive Affect Rating|Participants will provide ratings of positive affect, before and after each exercise, measured on a 10-point Likert scale (0-10). Weekly pre- and post-exercise ratings of happiness were averaged to provide an overall pre- and post-exercise score. Higher scores indicate higher levels of positive affect.|Weeks 1-10||||units on a scale||Standard Deviation|Mean
2545766|NCT02938052|Secondary|Immediate Impact of the Exercises: Optimism Rating|Participants will provide ratings of optimism before and after each exercise, measured on a 10-point Likert scale (0-10). Weekly pre- and post-exercise ratings of optimism were averaged to provide an overall pre- and post-exercise optimism score. Higher scores indicate higher levels of optimism.|Weeks 1-10||||units on a scale||Standard Deviation|Mean
2545767|NCT02938052|Secondary|Acceptability of the Exercises: Ease Score|Participants will provide ratings of ease after each exercise, measured on a 10-point Likert scale (0-10). Higher scores indicate greater ease of the exercise. Weekly ease ratings were averaged to provide an overall easy score of the exercises.|Weeks 1-10||||units on a scale||Standard Deviation|Mean
2545768|NCT02938052|Secondary|Acceptability of the Exercises: Utility Score|Participants will provide ratings of utility after each exercise, measured on a 10-point Likert scale (0-10). Higher scores indicate greater utility of the exercise. Weekly utility ratings were averaged to provide an overall utility score of the exercises.|Weeks 1-10||||units on a scale||Standard Deviation|Mean
2545769|NCT02938052|Secondary|Feasibility of Actigraph|Feasibility will be measured by examining the number of participants who use of the Actigraph.|Baseline and 10 weeks||||Participants|||Count of Participants
2545770|NCT02938052|Secondary|Change in Moderate to Vigorous Physical Activity (Actigraph)|ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at baseline and again for one week at 10 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity. Change was calculated by subtracting the MVPA at baseline from the MVPA at 10 weeks.|Change in MVPA from Baseline to 10 weeks||||minutes/day||Standard Deviation|Mean
2545771|NCT02938052|Secondary|Change in Physical Activity|Measured by Actigraph accelerometer, in number of steps per day.|Baseline and 10 weeks|Not all participants wore the Actigraph and provided adequate data.|||steps/day||Standard Deviation|Mean
2545772|NCT02938052|Secondary|Self-Reported Medication Adherence (SRMA)|The Self-Reported Medication Adherence (SRMA) asks what percent of the time (in 10% increments) participants took all of their medications as prescribed in the past week and in the past 2 weeks (Range: 0-10). Change was calculated by subtracting the score at baseline from the score at 10 weeks.|Change in score from Baseline to 10 weeks||||percentage of time||Standard Deviation|Mean
2545773|NCT02938052|Secondary|Changes in Daily Sodium Intake (as Measured With the SSQ)|"The Scored Sodium Questionnaire (SSQ) is a self-report scale that assesses the frequency with which participants consume a variety of sodium-containing foods, ranging from Rarely or Never Eaten to At Least Once Daily. It is used to calculate daily sodium intake (Range: 0-215). Change was calculated by subtracting the score at baseline from the score at 10 weeks. Higher scores indicate higher sodium intake."|Change in score from Baseline to 10 weeks||||units on a scale||Standard Deviation|Mean
2545774|NCT02938052|Secondary|Changes in MOS SAS Scores|Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score (Range: 3-18). Change was calculated by subtracting the score at baseline from the score at 10 weeks. Higher scores indicate better adherence to health behaviors.|Change in score from Baseline to 10 weeks||||units on a scale||Standard Deviation|Mean
2545775|NCT02938052|Secondary|Changes in SF-12 Scores|The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life. This is an instrument which has been used in multiple cardiac studies in the past (SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each). Change was calculated by subtracting the score at baseline from the score at 10 weeks. Higher scores indicate higher level of health related QoL.|Change in score from Baseline to 10 weeks||||units on a scale||Standard Deviation|Mean
2545840|NCT02935894|Secondary|Change in Plasma Ibuprofen Concentrations|Plasma concentration of ibuprofen prior to and 30 min, 2 hr and 4 hr after oral administration|measured at four timepoints at study visit 4|Of the 14 subjects recruited for this study, only 9 provided usable data for this primary outcome.|||micrograms per milliliter||Full Range|Geometric Mean
2545776|NCT02938052|Secondary|Changes in KCCQ Scores|The Kansas City Cardiomyopathy Questionnaire is a well-validated questionnaire of health status in HF. The full scale will be used to measure HF-specific health-related QoL (HRQoL), and an eight-question subset of the KCCQ will be used as a measure of HF symptoms (QoL score range: 0-100; total symptom score range: 0-100). Change was calculated by subtracting the score at baseline from the score at 10 weeks. Higher QoL scores indicate better HF specific health-related QoL, and higher total symptom scores indicate fewer symptoms.|Change in score from Baseline to 10 weeks||||units on a scale||Standard Deviation|Mean
2545777|NCT02938052|Secondary|Change in HADS-Depression Subscale Scores|The Hospital Anxiety and Depression Scale (HADS)-depression subscale was be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 10 weeks. Higher scores indicate worse outcome (i.e. greater levels of depression).|Change in score from Baseline to 10 weeks||||units on a scale||Standard Deviation|Mean
2545778|NCT02938052|Secondary|Changes in HADS-Anxiety Subscale Scores|The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale was be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 10 weeks. Higher scores indicate higher levels of anxiety.|Change in score from Baseline to 10 weeks||||units on a scale||Standard Deviation|Mean
2545779|NCT02938052|Secondary|Changes in LOT-R Scores|Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24). Change was calculated by subtracting the score at baseline from the score at 10 weeks. Higher scores indicate higher levels of optimism.|Change of score from Baseline to 10 weeks||||units on a scale||Standard Deviation|Mean
2545780|NCT02938052|Secondary|Changes in PANAS Scores|The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with HF, will be used to measure positive affect (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 10 weeks. Higher scores indicate higher levels of positive affect.|Change in score from Baseline to 10 weeks||||units on a scale||Standard Deviation|Mean
2545781|NCT02938052|Primary|Feasibility of the PP-based Health Behavior Intervention|Feasibility will be measured by examining the number of completed exercises.|10 weeks||||Exercises Completed||Standard Deviation|Mean
2545782|NCT02937870|Secondary|Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Test Adhesive 2|Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.|up to 12 hours|Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome.|||lbs||Standard Error|Least Squares Mean
2545783|NCT02937870|Secondary|Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. Positive Control Adhesive|Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.|up to 12 hours|Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome.|||lbs||Standard Error|Least Squares Mean
2545784|NCT02937870|Secondary|Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 vs. Positive Control Adhesive|Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.|up to 12 hours|Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome.|||lbs||Standard Error|Least Squares Mean
2545785|NCT02937870|Primary|Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 2 vs. No Adhesive|Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (lbs). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.|up to 12 hours|Analysis for this outcome was performed on ITT population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome.|||lbs||Standard Error|Least Squares Mean
2545786|NCT02937870|Primary|Area Over Baseline Over 12 Hours (AOB0-12) for Test Adhesive 1 Versus (vs.) No Adhesive|Area over baseline over 12 hours (AOB0-12) was assessed to measure the incisal bite force. AOB0-12 was calculated as area under the curve over 12 hours [AUC0-12])/12 hours minus baseline bite force (pounds [lbs]). AUC0-12 was calculated using the trapezoidal method. This transformation returned the measurement to the same scale as the original observations. Higher values of AOB0-12 demonstrate a stronger bite force overtime than lower values.|up to 12 hours|Analysis for this outcome was performed on intent-to-treat (ITT) population which included all randomized participants with at least one post baseline assessment of efficacy. Number of participants analyzed are the participants from ITT population analyzed for this outcome.|||lbs||Standard Error|Least Squares Mean
2545906|NCT02935192|Primary|Number of Participants With Solicited Local Adverse Events (Local Reactogenicity)|Number of subjects reporting one or more solicited local reactions (redness/erythema, swelling/induration, pain, and tenderness) at the injection site post-vaccination with study vaccine or placebo|5-day period (Days 1-5) post-vaccination|Full analysis population|||Participants|||Count of Participants
2545787|NCT02937766|Secondary|Clinician Assessment of Ease of Drug Preparation|"Investigate the clinician's assessment of the ease of drug preparation associated with the administration of Makena® via subcutaneous auto-injector versus intramuscular injection as measured by a categorical scale.~Scores were as follows: completely dissatisfied = -3; mostly dissatisfied = -2, somewhat dissatisfied = -1, neither satisfied nor unsatisfied = 0, somewhat satisfied = 1, mostly satisfied = 2, completely satisfied = 3"|4 weeks|Analysis population is comprised of all subjects who were randomized and received study drug.|||units on a scale||Standard Deviation|Mean
2545788|NCT02937766|Secondary|Clinician Assessment of Ease of Injection Technique|"Investigate the clinician's assessment of the ease of injection technique associated with the administration of Makena® via subcutaneous auto-injector versus intramuscular injection as measured by a categorical scale.~Scores were as follows: completely dissatisfied = -3; mostly dissatisfied = -2, somewhat dissatisfied = -1, neither satisfied nor unsatisfied = 0, somewhat satisfied = 1, mostly satisfied = 2, completely satisfied = 3"|4 weeks|Analysis population is comprised of all subjects who were randomized and received study drug.|||units on a scale||Standard Deviation|Mean
2545789|NCT02937766|Primary|Comparison of Average Pain Intensity|"Comparison of average pain intensity associated with the administration of Makena® via subcutaneous autoinjector versus intramuscular injection (averaged over 4 visits).~Score on a scale: 0 (No Pain) up to 10 (Worst Pain Imaginable)"|4 weeks|The Comparison of Average Pain Intensity outcome was not analyzed. Pain assessments for participants included Adverse Events of Injection Site Pain reporting. 3 participants in Treatment Group A and 2 participants in Treatment Group B reported Injection Site Pain.|||Participants with Injection Site Pain|||Number
2545790|NCT02937740|Secondary|Frequency of Daily Dose of NATESTO by the End of the Study|Frequency of daily dosing, i.e. how many patients remained on BID vs how many were uptitrated to TID by the end of the study.|3 months for those who remained on BID, 4 months for those uptitrated to TID|ITT population|||Participants|||Count of Participants
2545791|NCT02937740|Secondary|Patient Treatment Preference Versus Prior Testosterone Replacement Therapy|Patient treatment preference versus prior testosterone replacement therapy measured by the Treatment Preference questionnaire.|Last visit, i.e. 3 months for BID, 4 months for TID|Number of participants includes BID and TID patients for each Arm. The number is different than the total number of patients who completed because some subjects did not provide a response to this question.|||Participants|||Count of Participants
2545792|NCT02937740|Secondary|Change in Hypogonadism Symptoms|Change in hypogonadism symptoms from baseline as measured by qADAM, a 10 point validated instrument. qADAM is a 10-item, patient-reported outcome measure used to evaluate the symptom severity of hypogonadism. Responses can range from 1 to 5 per question allowing for a minimum to maximum score range of 10 to 50. Higher values imply a better outcome.|Baseline and 3 months for BID, 4 months for TID|ITT population, no-LOCF|||Units on a scale||Standard Deviation|Mean
2545793|NCT02937740|Primary|Patient Satisfaction - Change From Baseline|The primary objective of this study is to measure patient satisfaction with testosterone replacement therapy before, during and after treatment with NATESTO. Patient satisfaction with treatment will be measured by TSQM (Treatment Satisfaction Questionnaire for Medication) Version 9, a 9-item validated instrument. TSQM domains include - Effectiveness, Convenience, Global Satisfaction. The score for each domain is converted into a scale out of 100. Higher values imply a better outcome.|Baseline and 3 months for BID, 4 months for TID||||Units on a scale||Standard Deviation|Mean
2545794|NCT02937701|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count~C-reactive protein (CRP)~Patient's global health assessment measured on a 100 mm VAS, where 0 mm = no RA activity and 100 mm = worst RA activity imaginable.~DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and weeks 30, 34, 38, 46, and 50|Participants re-randomized at week 22 (includes participants initially randomized to ABP 710 who continued treatment with ABP 710 at week 22) and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2545795|NCT02937701|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) Through Week 22|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count~C-reactive protein (CRP)~Patient's global health assessment measured on a 100 mm VAS, where 0 mm = no RA activity and 100 mm = worst RA activity imaginable.~DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and weeks 2, 6, 14, and 22|Intent-to-treat population with available data at each time point.|||units on a scale||Standard Deviation|Mean
2545796|NCT02937701|Secondary|Percentage of Participants With an ACR70 Response After Week 22|"A positive ACR70 response is defined if the following 3 criteria for improvement from baseline were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global health assessment (measured on a 100 mm VAS);~Investigator's global health assessment (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein concentration."|Baseline and weeks 30, 34, 38, 46, and 50|Participants re-randomized at week 22 (includes participants initially randomized to ABP 710 who continued treatment with ABP 710 at week 22); participants with missing data at a given visit were counted as non-responders.|||percentage of participants||95% Confidence Interval|Number
2545818|NCT02937558|Secondary|Number of Subjects With Clinically Meaningful Reduction in Glucose Infusion Rate (Open-Label)|Change from baseline in glucose infusion rate (GIR) will be determined for each subject at the end of open-label treatment. Subjects with a decrease in GIR ≥ 33% will be considered to have had a clinically meaningful treatment response.|Baseline to the end of open-label treatment at 72 hours|Evaluable subjects|||Participants|||Count of Participants
2545819|NCT02937558|Secondary|Percent Change in GIR (Double-Blind)|The groups will be compared for mean percent change in GIR from baseline to the end of the double-blind study phase.|Baseline to the end of blinded treatment at 24 or 48 hours|Evaluable subjects|||% change||Standard Deviation|Mean
2545797|NCT02937701|Secondary|Percentage of Participants With an ACR70 Response Through Week 22|"A positive ACR70 response is defined if the following 3 criteria for improvement from baseline were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global health assessment (measured on a 100 mm VAS);~Investigator's global health assessment (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein concentration."|Baseline and weeks 2, 6, 14, and 22|Intent-to-treat population; participants with missing data at a given visit were counted as non-responders.|||percentage of participants||95% Confidence Interval|Number
2545798|NCT02937701|Secondary|Percentage of Participants With an ACR50 Response After Week 22|"A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global health assessment (measured on a 100 mm VAS);~Investigator's global health assessment (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein concentration."|Baseline and weeks 30, 34, 38, 46, and 50|Participants re-randomized at week 22 (includes participants initially randomized to ABP 710 who continued treatment with ABP 710 at week 22); participants with missing data at a given visit were counted as non-responders.|||percentage of participants||95% Confidence Interval|Number
2545799|NCT02937701|Secondary|Percentage of Participants With an ACR50 Response Through Week 22|"A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global health assessment (measured on a 100 mm VAS);~Investigator's global health assessment (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein concentration."|Baseline and weeks 2, 6, 14, and 22|Intent-to-treat population; participants with missing data at a given visit were counted as non-responders.|||percentage of participants||95% Confidence Interval|Number
2545800|NCT02937701|Secondary|Percentage of Participants With an ACR20 Response After Week 22|"A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global health assessment (measured on a 100 mm VAS);~Investigator's global health assessment (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein concentration."|Baseline and weeks 30, 34, 38, 46, and 50|Participants re-randomized at week 22 (includes participants initially randomized to ABP 710 who continued treatment with ABP 710 at week 22); participants with missing data at a given visit were counted as non-responders.|||percentage of participants||95% Confidence Interval|Number
2545801|NCT02937701|Secondary|Percentage of Participants With an ACR20 Response Through Week 14|"A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global health assessment (measured on a 100 mm VAS);~Investigator's global health assessment (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein concentration."|Baseline and weeks 2, 6, and 14|Intent-to-treat population; participants with missing data at a given visit were counted as non-responders.|||percentage of participants||95% Confidence Interval|Number
2545802|NCT02937701|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22|"The primary efficacy endpoint was the response difference (RD) of 20% improvement in ACR core set measurements (ACR20) at week 22.~A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global health assessment (measured on a 100 mm VAS);~Investigator's global health assessment (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein concentration."|Baseline and week 22|Intent-to-treat population; Participants with missing data at week 22 were counted as non-responders|||percentage of participants||95% Confidence Interval|Number
2545803|NCT02937636|Secondary|Mean Plaque Index (PI) (Overall and Interproximal)|The dental examiner used the PI to assess plaque on all gradable teeth. The plaque was first disclosed using a dye solution. Participants then rinsed with disclosing solution according to instructions. Plaque was assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque was scored as follows: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth.Overall PI score and interproximal PI score were calculated as the mean PI over all tooth sites and mean PI over interproximal sites (distal and mesial) respectively.|At Week 12|The ITT (n=128) population is defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.|||Score on Scale||Standard Deviation|Mean
2545820|NCT02937558|Primary|Number of Subjects With Clinically Meaningful Reduction in Glucose Infusion Rate (Double-Blind)|Change from baseline in glucose infusion rate (GIR) will be determined for each subject at 24 and 48 hours from the start of blinded treatment. Subjects with a decrease in GIR ≥ 20% at 24 hours, and ≥ 33% at 48 hours will be considered to have had a clinically meaningful treatment response.|Baseline to end of blinded treatment at 24 or 48 hours|Evaluable subjects|||Participants|||Count of Participants
2545804|NCT02937636|Secondary|Mean Modified Gingival Index (MGI)|The MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin).The scoring of MGI was performed by a single examiner. The MGI scoring system is as follows:0=absence of inflammation;1=mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit;2=mild inflammation; criteria as above but involving the entire marginal or papillar gingival units;3=moderate inflammation; glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit;4=severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration.|At Week 12|The ITT (n=128) population is defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.|||Score On Scale||Standard Deviation|Mean
2545805|NCT02937636|Secondary|Number of Bleeding Sites|Number of bleeding sites were measured as BI via a single examiner using a color coded periodontal probe. The probe was gently inserted approximately 1 millimeter (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.|At Week 12|The ITT (n=128) population is defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.|||Number of bleeding sites||Standard Deviation|Mean
2545806|NCT02937636|Primary|Mean Bleeding Index (BI)|The BI was performed by a single examiner using a color coded periodontal probe. The probe was inserted approximately 1 mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. This measure will be analyzed and summarized over all sites.|At Week 12|The intent to treat (ITT) (n=128) population is defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.|||Score on Scale||Standard Deviation|Mean
2545807|NCT02937623|Secondary|Change From Baseline in Numerical Rating Scale (NRS) Scores After 10 Minutes, 2 Hours and 4 Hours|Participants rated the intensity of their response to the evaporative air stimulus using a 10 point numerical rating scale of 1 (No Pain) to 10 (Intense Pain).|At baseline(pre-treatment), 10 minutes, 2 hours and 4 hours post treatment: Day 1 of the study|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
2545808|NCT02937623|Secondary|Change From Baseline in Tactile Threshold After 10 Minutes, 2 Hours and 4 Hours|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline (pre-treatment), the maximum force used was 20g; at all subsequent time points (post treatment), it was 80g.|At Baseline (pre-treatment), 10 minutes, 2 hours and 4 hours post treatment: Day 1 of the study|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||gram (g)||Standard Deviation|Mean
2545809|NCT02937623|Secondary|Change From Baseline in Schiff Sensitivity Score After 2 and 4 Hours|The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each test tooth, using the Schiff Sensitivity Scale as follows: 0= Participant does not respond to air stimulation, 1= Participant responds to air stimulus but does not request discontinuation of stimulus, 2= Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3= Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|At Baseline (pre-treatment), 2 and 4 hours post-treatment: Day 1 of the study|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
2545810|NCT02937623|Primary|Change From Baseline in Schiff Sensitivity Score After 10 Minutes|The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each test tooth, using the Schiff Sensitivity Scale as follows: 0= Participant does not respond to air stimulation, 1= Participant responds to air stimulus but does not request discontinuation of stimulus, 2= Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3= Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|At baseline (pre-treatment) and 10 minutes post-treatment: Day 1 of the study|Intent-to-treat (ITT) population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
2545811|NCT02937584|Secondary|Functional Residual Capacity (FRC)|Functional residual capacity (FRC). Ratio to baseline.|Baseline, Day 15|ITT Population|||ratio||95% Confidence Interval|Geometric Mean
2545812|NCT02937584|Secondary|FEV1|FEV1 Change from baseline in Forced Expiratory Volume at 1 second.|Baseline, Day 15|ITT Population|||L||Standard Deviation|Mean
2545813|NCT02937584|Secondary|Image-based Airway Resistance (iRaw)|Image-based airway resistance (iRaw) without correction for lobe volume. Ratio to baseline.|Baseline, Day 15|ITT Population|||ratio||95% Confidence Interval|Geometric Mean
2545814|NCT02937584|Secondary|Image-based Airway Volume (iVaw)|Image-based airway volume (iVaw) without correction for lobe volume. Ratio to baseline.|Baseline, Day 15|ITT Population|||ratio||95% Confidence Interval|Geometric Mean
2545815|NCT02937584|Primary|Specific Image-based Airway Resistance (siRaw)|Specific image-based airway resistance (siRaw). Average across lobes, adjusted for lobe volume. Ratio to baseline.|Baseline, Day 15|ITT Population|||ratio||95% Confidence Interval|Geometric Mean
2545822|NCT02937168|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.|21 days|All recruited healthy participants.|||Participants|||Count of Participants
2545823|NCT02937168|Secondary|Change From Baseline to Week 4 in Asthma Quality of Life Questionnaire (AQLQ) Score||Baseline, Week 4|Part 2 of the study was not conducted, hence this outcome measure was not analyzed.||||||
2545824|NCT02937168|Secondary|Change From Baseline to Week 4 in Fractional Exhaled Nitric Oxide (FeNO)||Baseline, Week 4|Part 2 of the study was not conducted, hence this outcome measure was not analyzed.||||||
2545825|NCT02937168|Secondary|Change From Baseline to Week 4 in Forced Expiratory Volume in 1 Second (FEV1)||Baseline, Week 4|Part 2 of the study was not conducted, hence this outcome measure was not analyzed.||||||
2545826|NCT02937168|Secondary|Part 2: Change From Baseline to Week 4 in Blood Eosinophil Counts||Baseline, Week 4|Part 2 of the study was not conducted, hence this outcome measure was not analyzed.||||||
2545827|NCT02937168|Primary|Part 2: Change From Baseline to Week 4 in Lung Parenchyma (LP) SUV Mean||Baseline, Week 4|Part 2 of the study was not conducted, hence this outcome measure was not analyzed.||||||
2545828|NCT02937168|Primary|Part 2: Change From Baseline to Week 4 in GLG||Baseline, Week 4|Part 2 of the study was not conducted, hence this outcome measure was not analyzed.||||||
2545829|NCT02937168|Primary|Part 1: Average Global Lung Glycolysis (GLG) at Day 8|GLG is the total FDG uptake in the whole lung. ROI was drawn around lung boundary in each axial slice. SUV mean and area of each ROI was recorded. Using the formula: area*slice thickness the volume of each slice was calculated. Then the SUVmean of each slice was multiplied by the volume of the corresponding slice, which represented the total FDG uptake in one slice. This number for each slice was summed together to provide GLG of that lung. Average between GLG of right lung and GLG of left lung was reported.|Day 8|All recruited healthy participants.|||cm^3||Standard Deviation|Mean
2545830|NCT02937168|Primary|Part 1: Average Global Lung Glycolysis (GLG) at Baseline (Day 1)|GLG is the total FDG uptake in the whole lung. A region of interest (ROI) was drawn around lung boundary in each axial slice. Standardized uptake value (SUV) mean and area of each ROI was recorded. Using the formula: area*slice thickness the volume of each slice was calculated. Then the SUVmean of each slice was multiplied by the volume of the corresponding slice, which represented the total FDG uptake in one slice. This number for each slice was summed together to provide GLG of that lung. Average between GLG of right lung and GLG of left lung was reported.|Baseline (Day 1) of Part 1|All recruited healthy participants.|||cubic centimeters (cm^3)||Standard Deviation|Mean
2545831|NCT02936869|Secondary|Neonatal Postnatal Care Referral|Proportion of neonates delivered by the traditional birth attendant that are successfully referred for postnatal care within 48 hours of delivery|Within 48 hours of delivery|The analysis did not include data from 7 TBAs lost to follow-up.|||proportion of neonates referred||95% Confidence Interval|Number
2545832|NCT02936869|Primary|Maternal Postnatal Care Referral|The proportion of delivery clients that are successfully referred by the traditional birth attendant for postnatal care within 48 hours of delivery. For each delivery client that the traditional birth attendant reported, we visited at least three days after delivery to ascertain if they had been asked to visit the postnatal clinic, clarify if they had visited the clinic within 48 hours of delivery, and what care they had received (if yes). The team visited traditional birth attendants every two weeks to identify new clients. Where a new client was not up to three days post-delivery, the interview was postponed until the next visit by the team to the community. This occurred repeatedly, over a five-month frame.|Within 48 hours of delivery|The analysis did not include information from the 7 TBAs lost to follow-up.|||proportion of maternal clients referred||95% Confidence Interval|Number
2545833|NCT02936648|Primary|HCV Antibody Test|Number of Participants with HCV Antibody Test|within 30 days of outpatient primary care visit||||Participants|||Count of Participants
2545834|NCT02936479|Primary|Renal Allograft Survival Measured by Severe and Refractory Antibody Mediated Renal (AMR)|number of patients that presented with severe and refractory Antibody Mediated Renal (AMR) following kidney transplant and survived beyond one year after study drug administration|24 months||||Participants|||Count of Participants
2545835|NCT02936076|Secondary|Percentage of Overeating Episodes Characterized as 'Overeating'|If an eating episode occurred, participants were asked to check all that apply: a) I ate past the point of feeling full, b) I ate more than usual, c) I had unplanned eating (i.e., consumed food when I don't usually eat and was not making up for a missed meal, or d) None of the above. If response was a, b, or c, it was classified as an 'overeating episode'.|12 weeks||||% of eating episodes|||Number
2545836|NCT02936076|Secondary|Stress as Measured Via Questionnaire|The 10-item Perceived Stress Scale (Cohen 1988) was used to assess changes in stress by treatment arm from baseline to 12 weeks. Scores on this measure range from 0-40 with a higher score indicating greater perceived stress. Presented values are 12 week scores adjusted for baseline values.|Baseline and 12 weeks||||units on a scale||Standard Error|Least Squares Mean
2545837|NCT02936076|Secondary|Change in Body Weight (% Initial Weight)|Percent weight change from baseline to 12 weeks|baseline and 12 weeks||||percent change||Standard Deviation|Mean
2545838|NCT02936076|Primary|Stress-induced Overeating Measured Via Smartphone Surveys|Participants completed EMA surveys (5x/day for 14 days). At each prompt they were asked if an eating episode occurred. If they indicated 'yes', they were asked to check all that apply: a) I ate past the point of feeling full, b) I ate more than usual, c) I had unplanned eating (i.e., consumed food when I don't usually eat and was not making up for a missed meal, or d) None of the above. If the participant responded with a, b, or c, it was classified as an 'overeating episode'. Further, at each prompt, participants were asked to the respond to the following: 'Right now I feel stressed' (1=not at all, 7=very much so). If the stress score was >=5 at the prompt just prior to an overeating episode, then it was considered a 'stress-induced overeating episode'.|12 weeks||||episodes||Standard Deviation|Mean
2545841|NCT02935894|Secondary|Change in Pilocarpine-stimulated Sweat Lipid Mediator Concentrations Before and After Oral Ibuprofen Administration|Approximately 100 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids, and endocannabinoid-like molecules.|measured at four timepoints at study visit 4, detected lipid mediator concentrations for first timepoint reported|Of the 14 subjects recruited for this study, only 9 provided usable data for this primary outcome.|||picomoles per milliliter||Full Range|Geometric Mean
2545842|NCT02935894|Primary|Change in Plasma Lipid Mediator Concentrations Before and After Oral Ibuprofen Administration|Approximately 100 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids, and endocannabinoid-like molecules.|measured at four timepoints at study visit 4, detected lipid mediator concentrations for first timepoint reported|Of the 14 subjects recruited for this study, only 9 provided usable data for this primary outcome.|||picomoles per milliliter||Full Range|Geometric Mean
2545843|NCT02935894|Primary|Anterior Distal Thigh Sweat Lipid Mediator Concentrations Following Pilocarpine Stimulation|Approximately 150 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids and endocannabinoid-like molecules, and sphingolipids.|measured at study visit 2, detected lipid mediator concentrations reported|Of the 14 subjects recruited for this study, only 4 provided usable data for this primary outcome.|||picomoles per milliliter||Standard Deviation|Mean
2545844|NCT02935894|Primary|Lower Back Sweat Lipid Mediator Concentrations Following Pilocarpine Stimulation|Approximately 150 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids and endocannabinoid-like molecules, and sphingolipids.|measured at study visit 1, detected lipid mediator concentrations reported|Of the 14 subjects recruited for this study, only 4 provided usable data for this primary outcome.|||picomoles per milliliter||Standard Deviation|Mean
2545845|NCT02935894|Primary|Volar Forearm Sweat Lipid Mediator Concentrations Following Exercise|Approximately 150 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids and endocannabinoid-like molecules, and sphingolipids.|measured at study visit 1, detected lipid mediator concentrations reported|Of the 14 subjects recruited for this study, only 7 provided usable data for this primary outcome.|||picomoles per milliliter||Standard Deviation|Mean
2545846|NCT02935894|Primary|Volar Forearm Sweat Lipid Mediator Concentrations Following Pilocarpine Stimulation|Approximately 150 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids and endocannabinoid-like molecules, and sphingolipids.|measured at study visit 1, 2 and 3; detected lipid mediator concentrations for study visit 1 reported|Of the 14 subjects recruited for this study, only 7 provided usable data for this primary outcome.|||picomoles per milliliter||Standard Deviation|Mean
2545847|NCT02935699|Secondary|Patient Sedation Scores|"Patient Sedation Score at 2 hours~Ask the patient How drowsy do you feel at the moment? 0 = None (Not drowsy at all)~= Mild (Slightly drowsy)~= Moderate (Quite drowsy)~= Severe (Extremely drowsy)"|2 hours|Intent To Treat Population|||score on a scale||Standard Deviation|Mean
2545848|NCT02935699|Secondary|Time to Discharge|Time spent (hours) at the treatment center|up to 24 hours|Intent To Treat Population|||hours||Standard Deviation|Mean
2545849|NCT02935699|Secondary|Number of Patients Who Needed to Return to Treatment Center|Number of patients who needed to return to treatment center approximately 24 hours after discharge|up to 24 hrs|Intent To Treat Population|||Participants|||Count of Participants
2545850|NCT02935699|Primary|Change of Patient Rated Pruritus Score|"Change from baseline to 2 hours in patient-rated pruritus Severity score (values at 2 hours minus Baseline)~Patient Pruritus Severity Score Ask the patient How severely are your hives itching at the moment? 0 = none~= mild (minimal awareness, easily tolerated)~= moderate (definite awareness, quite bothersome)~= severe (difficult to tolerate)"|2 hr|Intent To Treat population|||score on a scale||Standard Deviation|Mean
2545851|NCT02935673|Secondary|Number of Participants With Postbaseline Changes in the RSV Polymerase L Gene and Other Regions of the RSV Genome Compared With Baseline Sequences|Number of participants with postbaseline changes in the RSV polymerase L gene and other regions of the RSV genome compared with baseline sequences were reported.|Baseline up to 28 Days|Analysis was performed on ITT-i set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.|||Participants|||Count of Participants
2545852|NCT02935673|Secondary|RSV RNA Viral Load AUC in Participants Assigned to a Longer Dosing Duration|RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples (obtained from intubated participants or via suction through tracheostomy or other sampling.|Up to 1 Day after the last dose of study drug|ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. No participant received extended treatment, therefore data was not analyzed.||||||
2545853|NCT02935673|Secondary|RSV RNA Viral Load AUC up to Day 14|RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples (obtained from intubated participants or via suction through tracheostomy or other sampling.|Up to Day 14|Data was not collected and analyzed because this study was stopped prematurely.||||||
2545854|NCT02935673|Secondary|Number of Participants With Undetectable Viral Load|Number of participants with undetectable viral load up to 28 days were reported.|Up to 28 Days|ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.|||Participants|||Count of Participants
2545855|NCT02935673|Secondary|Time to RSV RNA Viral Load Being Undetectable|It is the time in hours from initiation of study treatment until the first post baseline time point at which the virus is undetectable in an assessment and after which time no detectable virus assessment follows as measured by qRT-PCR.|Up to 28 Days|Data was not collected and analyzed because this study was stopped prematurely.||||||
2550643|NCT02829944|Secondary|Number of Subjects Experiencing Vomiting|Asking patients whether or not they experienced the symptom in the preceding time-frame|2 hours||||Participants|||Count of Participants
2545856|NCT02935673|Secondary|Rate of Decline of Viral Load|Rate of decline of viral load over the first 24 hours calculated as a log decline/24 hours defined as: 24-hour log viral load after first dose of study drug minus (-) log viral load at baseline divided by (/) date/time of 24-hour viral load sample - date/time of baseline viral load.|Up to 28 Days|Data was not collected and analyzed because this study was stopped prematurely.||||||
2545857|NCT02935673|Secondary|Time to Peak Viral Load|Time to peak viral load is the time from initiation of study treatment until the first time point with the peak viral load.|Up to 28 Days|Data was not collected and analyzed because this study was stopped prematurely.||||||
2545858|NCT02935673|Secondary|Peak Viral Load|Peak Viral load is the highest value of log10 viral load at or after the baseline measurement. Peak viral load over time was measured by qRT-PCR.|Up to 28 Days|Data was not collected and analyzed because this study was stopped prematurely.||||||
2545859|NCT02935673|Secondary|RSV RNA Viral Load Over Time|Antiviral activity RSV RNA viral load was measured in mid-turbinate nasal swabs (obtained from non-intubated participants) or in mid-turbinate nasal swabs and endotracheal samples (obtained from intubated participants or via suction through tracheostomy or other sampling methods) using qRT-PCR performed at the central laboratory.|Days 2, 3, 4, 5, 6, 7, 10, 14, and 28|Analysis was performed on ITT-i set. Here 'n' (number analyzed) signifies number of participants evaluable for each time point. Analyses were conducted on pooled groups across the 3 study parts.|||log10 copies/mL||Standard Deviation|Mean
2545860|NCT02935673|Secondary|Number of Participants With All-Cause Mortality|All-cause mortality included all deaths of participants due to any cause.|Up to 28 Days|Safety set included all participants who received at least 1 dose of study drug, analyzed as treated. Analyses were conducted on pooled groups across the 3 study parts.|||Participants|||Count of Participants
2545861|NCT02935673|Secondary|Number of Participants in Each Ordinal Scale Category|Number of participants in each ordinal scale category were reported. Ordinal scale consists of 6 categories or clinical states that are exhaustive, mutually exclusive, and ordered: category 1) death; category 2) admitted to ICU; category 3) non-ICU hospitalization requiring supplemental oxygen; category 4) non-ICU hospitalization not requiring supplemental oxygen; category 5) not hospitalized, unable to resume normal activities; category 6) not hospitalized, resumption of normal activities.|Day 5/6 (Day of last study treatment)|ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.|||Participants|||Count of Participants
2545862|NCT02935673|Secondary|Time to Clinical Stability|Time to clinical stability is defined as the time from first dose of study drug until the time at which the following criteria were all met: normalization of blood oxygen level (return to baseline; by pulse oximetry) without requirement of supplemental oxygen beyond baseline level, normalization of oral feeding, normalization of respiratory rate and normalization of heart rate.|Up to 28 Days|ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.|||Hours||Standard Deviation|Mean
2545863|NCT02935673|Secondary|Number of Participants Who Required Hydration or Feeding by Intravenous (IV) Catheter or Nasogastric Tube|Number of participants who required hydration or feeding by IV catheter or nasogastric tube were reported.|Up to 28 Days|ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.|||Participants|||Count of Participants
2545864|NCT02935673|Secondary|Time to Return to Pre-RSV Functional Status as Assessed by KATZ Activities of Daily Living (ADL) Score|It is the time from first dose of study drug until the time to return to pre-RSV functional status. Functional status is the total points on the KATZ index of independence in activities of daily living (KATZ ADL score). Katz activities of daily living assessed questions related to bathing, dressing, toileting, transferring, continence and feeding components. Total score was calculated by adding the scores for all 6 activities which ranges from 0 high (participant independent) to 6 low (participant very dependent). If one or more component was missing, then the KATZ ADL score was not calculated. The return to pre-RSV functional status occurs at the timepoint where for the first time the KATZ ADL score is equal or higher than the pre-RSV KATZ ADL score and after which no scores lower than the pre-RSV KATZ ADL score occur anymore.|Up to 28 Days|ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.|||Days||Standard Deviation|Mean
2545865|NCT02935673|Secondary|Time to End of Invasive Mechanical Ventilation Support|It is the time from first dose of study drug to the last end date and time of invasive mechanical ventilation support in hours.|Up to 28 Days|ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Overall number of participants analyzed is zero, since none of the participants required mechanical ventilation support.||||||
2545866|NCT02935673|Secondary|Number of Participants Who Required Invasive Mechanical Ventilation Support|Number of participants who required invasive mechanical ventilation support were reported.|Up to 28 Days|ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.|||Participants|||Count of Participants
2545867|NCT02935673|Secondary|Time to End of Noninvasive Mechanical Ventilation Support|It is the time from first dose of study drug to the last end date and time of noninvasive mechanical ventilation support in hours.|Up to 28 Days|Population included ITT-i set who required noninvasive mechanical ventilation support. Analyses were conducted on pooled groups across the 3 study parts.|||Hours||Standard Deviation|Mean
2545907|NCT02935192|Primary|Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity)|Number of participants experiencing one or more solicited local AEs, including redness /erythema, swelling / induration and pain|30-minute post-vaccination period|The analysis was conducted for subjects who were randomized and received a study vaccination|||Participants|||Count of Participants
2545868|NCT02935673|Secondary|Number of Participants Who Required Noninvasive Mechanical Ventilation Support|Number of participants who required noninvasive mechanical ventilation support (that is supplemental oxygen [excluding mechanical ventilation]) were reported.|Up to 28 Days|ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.|||Participants|||Count of Participants
2545869|NCT02935673|Secondary|Time to Return to Pre-RSV Disease Level for Body Temperature|It is the time from first dose of study drug until the time to return to pre-RSV disease level for body temperature. The return to pre-RSV disease level occurred when the observed value of the parameter was indicated by the investigator as normal, and no later observed values were indicated by the investigator as abnormal.|Up to 28 Days|Data was not collected and analyzed because this study was stopped prematurely.||||||
2545870|NCT02935673|Secondary|Time to Return to Pre-RSV Disease Level for Oxygen Saturation|It is the time from first dose of study drug until the time to return to pre-RSV disease level for oxygen saturation. The return to pre-RSV disease level occurred when the observed value of the parameter was indicated by the investigator as normal, and no later observed values were indicated by the investigator as abnormal.|Up to 28 Days|ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.|||Hours||Standard Deviation|Mean
2545871|NCT02935673|Secondary|Time to Return to Pre-respiratory Syncytial Virus (Pre-RSV) Disease Level for Respiratory Rate|It is the time from first dose of study drug until the time to return to pre-RSV disease level for respiratory rate. The return to pre-RSV disease level occurred when the observed value of the parameter was indicated by the investigator as normal, and no later observed values were indicated by the investigator as abnormal.|Up to 28 Days|ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.|||Hours||Standard Deviation|Mean
2545872|NCT02935673|Secondary|Time (Number of Hours) Until Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to (>=) 93 Percent (%) on Room Air Among Participants Who Were Not on Supplemental Oxygen Prior to the Onset of Respiratory Symptoms|Time (number of hours) until SpO2 >= 93% on room air among participants who were not on supplemental oxygen prior to the onset of respiratory symptoms was reported.|Up to 28 Days|Data was not collected and analyzed because this study was stopped prematurely.||||||
2545873|NCT02935673|Secondary|Time to End of Oxygen Supplementation|It is the time from first dose of study drug to the last end date and time of any oxygen supplementation in hours.|Up to 28 Days|Population included ITT-i set who required supplemental oxygen. Analyses were conducted on pooled groups across the 3 study parts.|||Hours||Standard Deviation|Mean
2545874|NCT02935673|Secondary|Number of Participants Who Required Supplemental Oxygen|Number of participants who required supplemental oxygen were reported.|Up to 28 Days|ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.|||Participants|||Count of Participants
2545875|NCT02935673|Secondary|Duration of Intensive Care Unit Stay|In the event that a participant required ICU since initiation of treatment, the duration for how long the participant remained in the ICU was measured.|Up to 28 Days|ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Overall number of participants analyzed is 0, since none of the participants were admitted to ICU since initiation of treatment.||||||
2545876|NCT02935673|Secondary|Number of Participants Who Required to be Admitted to the Intensive Care Unit (ICU) Since Initiation of Treatment|Number of participants who required to be admitted to the ICU since initiation of treatment were reported.|Up to 28 Days|ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.|||Participants|||Count of Participants
2545877|NCT02935673|Secondary|Time of Hospital Stay From Admission to Readiness for Discharge|It is the time from hospital admission to readiness for discharge in hours, with readiness for discharge defined by the investigator.|Up to 28 Days|Analysis was performed on ITT-i set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.|||Hours||Standard Deviation|Mean
2545878|NCT02935673|Secondary|Time of Hospital Stay From Study Treatment Initiation to Readiness for Discharge|It is the time from study treatment initiation to readiness for discharge in hours, with readiness for discharge defined by the investigator.|From study treatment initiation to readiness for discharge on Day 2 or up to Day 6 if hospitalization is prolonged|ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.|||Hours||Standard Deviation|Mean
2545879|NCT02935673|Secondary|Time of Hospital Stay From Admission to Discharge|It is the time from hospital admission to hospital discharge in hours.|From admission to discharge (Up to 28 Days)|Analysis was performed on ITT-i set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.|||Hours||Standard Deviation|Mean
2545880|NCT02935673|Secondary|Time of Hospital Stay From Study Treatment Initiation to Discharge|It is the time from treatment initiation to hospital discharge in hours.|From study treatment initiation to discharge (Up to 28 Days)|ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.|||Hours||Standard Deviation|Mean
2545908|NCT02935179|Secondary|Body Fat After Intervention|Body fat change after 60 days intervention|60 days||||percentage of body fat||Standard Deviation|Mean
2545881|NCT02935673|Secondary|Number of Participants With Clinical Laboratory Abnormalities|Number of participants with clinical laboratory (serum chemistry and hematology) abnormalities were reported. Abbreviations; Erythrocyte MCHC = Erythrocyte Mean Corpuscular Hemoglobin Concentration; Erythrocyte MCH = Erythrocyte Mean Corpuscular Hemoglobin; Ery. = Erythrocyte|Up to 28 Days|Safety set included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'n' (number analyzed) signifies number of participants evaluable for specified categories. Analyses were conducted on pooled groups across the 3 study parts.|||Participants|||Count of Participants
2545882|NCT02935673|Secondary|Number of Participants With QT Interval Abnormalities|Number of participants with QT interval abnormalities (prolonged) were reported.|Up to 28 Days|Safety set included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.|||Participants|||Count of Participants
2545883|NCT02935673|Secondary|Number of Participants With Vital Sign Abnormalities|Number of participants with vital sign (systolic and diastolic blood pressure [BP], pulse rate, respiratory rate, temperature and oxygen saturation) abnormalities were reported. For systolic BP: abnormally low refers to less than or equal to (<=) 90 millimeter of mercury (mmHg); for diastolic BP: abnormally low refers to <= 50 mmHg; for pulse rate abnormally low refers to less than (<) 45 beats per minutes (bpm) and abnormally high refers to greater than or equal to (>=) 120 bpm; for temperature in degree Celsius abnormally high refers to greater than (>) 37.8 (tympanic), >38.0 (forehead), >38.0 (oral), >37.2 (rectal), >38.0 (axillary); for oxygen saturation in percentage (%) abnormally low refers to < 95. Grade 1 = mild; grade 2 = moderate; grade 3 = severe.|Up to 28 Days|Safety set included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'n' (number analyzed) signifies number of participants evaluable for specified categories. Analyses were conducted on pooled groups across the 3 study parts.|||Participants|||Count of Participants
2545884|NCT02935673|Secondary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.|Up to 28 Days|Safety set included all participants who received at least 1 dose of study drug, analyzed as treated. Analyses were conducted on pooled groups across the 3 study parts.|||Participants|||Count of Participants
2545885|NCT02935673|Primary|Least Square Mean Difference (Low and High Dose Lumicitabine Versus Placebo) of Respiratory Syncytial Virus (RSV) Ribonucleic Acid (RNA) Viral Load Area Under the Concentration-time Curve From Day 1 to 7 (AUC[1-7])|RSV RNA viral load in log10 copies/milliliter/day (log10 copies/mL/day) was measured in mid-turbinate nasal swabs and in endotracheal samples (obtained from intubated participants or via suction through tracheostomy or other sampling methods) using quantitative reverse transcription-polymerase chain reaction (qRT-PCR). Due to early termination of study, the analysis was not conducted as planned. Instead, using the same specification as for the primary analysis, a comparison was made on the AUC(1-7) days of pooled active treatment groups versus pooled placebo. The comparison was done as planned using a mixed model for repeated measures, using all available viral load data of baseline up to and including Day 7. The model computes the AUC at group level based on all available data, taking missing data into account under the missing at random assumption. The table reports the planned difference versus (pooled) placebo. No adjustment for multiplicity was applied.|Day 1 (Baseline) to 7|Intent-to-treat-infected (ITT-i) set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts.|||log10 copies/mL/day||95% Confidence Interval|Least Squares Mean
2545886|NCT02935673|Primary|Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 5|Ctrough is the trough observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.|Day 5|PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.|||ng/mL||Standard Deviation|Mean
2545887|NCT02935673|Primary|Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 1|Ctrough is the trough observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.|Day 1|PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.|||ng/mL||Standard Deviation|Mean
2545888|NCT02935673|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 5|AUC(0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours after dosing of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.|Day 5|PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.|||ng*h/mL||Standard Deviation|Mean
2545889|NCT02935673|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 1|AUC(0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours after dosing of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.|Day 1|PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.|||nanogram*hour per milliliter (ng*h/mL)||Standard Deviation|Mean
2545909|NCT02935179|Primary|Body Weight After Intervention|Body weight change after 60 days intervention|60 days||||Kg||Standard Deviation|Mean
2545890|NCT02935673|Primary|Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 5|Cmax is the maximum observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.|Day 5|PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.|||ng/mL||Standard Deviation|Mean
2545891|NCT02935673|Primary|Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 1|Cmax is the maximum observed plasma concentration of JNJ-63549109. JNJ-63549109 is the metabolized product of lumicitabine.|Day 1|Pharmacokinetic (PK) analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2545892|NCT02935543|Secondary|Safety and Tolerability of CART19: Frequency and Severity of Adverse Events, Including, But Not Limited to, Cytokine Release Syndrome (CRS) and Macrophage Activation Syndrome (MAS).|Frequency and severity of adverse events, including, but not limited to, cytokine release syndrome (CRS) and macrophage activation syndrome (MAS).|one year||||percentage of participants|||Number
2545893|NCT02935543|Secondary|Percentage of Manufacturing Products That do Not Meet Release Criteria for Vector Transduction Efficiency, T Cell Product Purity, Viability, Sterility or Due to Tumor Contamination.|Percentage of manufacturing products that do not meet release criteria for vector transduction efficiency, T cell product purity, viability, sterility or due to tumor contamination.|prior to day 1||||percentage of products|||Number
2545894|NCT02935543|Secondary|Event Free Survival (EFS)|"Event free survival (EFS) is defined as the time from start of the first CART19 infusion to the earliest of the following:~Death from any cause Relapse~Treatment failure: Defined as no response in the study and discontinuation from the study due to any of the following reasons:~Adverse event(s)~Abnormal laboratory value(s)~Abnormal test procedure results~New cancer therapy (excluding HSCT when performed in CR or CRi)"|one year|data were not collected||||||
2545895|NCT02935543|Secondary|Relapse Free Survival (RFS)|Relapse free survival (RFS) is defined as the duration between the date when the response criteria of CR or CRi is first met to the date of relapse or death due to any cause.|one year|data were not collected||||||
2545896|NCT02935543|Secondary|Duration of Remission (DOR)|Duration of remission (DOR) is defined as the duration from the date when the response criteria of CR or CRi is first met to the date of relapse or death due to ALL.|one year|data were not collected||||||
2545897|NCT02935543|Secondary|Best Overall Survival (OS)|Overall survival (OS) is defined as the time from the date of the first CART19 infusion to the date of death due to any reason.|one year|data were not collected||||||
2545898|NCT02935543|Primary|The Incidence of Conversion of Minimal Residual Disease (MRD) to <0.01%|The incidence of conversion of minimal residual disease (MRD) to <0.01% after CART19 therapy in patients with MRD+ ALL during upfront treatment|Day 28||||Participants|||Count of Participants
2545899|NCT02935192|Primary|Geometric Mean Fold Rises (GMFRs) of Serum HAI Antibodies|GMFR calculated as GMT for of Serum HAI Antibodies Post-vaccination/Pre-vaccination; measured for each of the 3 antigens|Day 1 and Day 22|"Per Protocol (PP) Population:~Immunogenicity was assessed in a subset of 151 participants (per-protocol population) with valid post-vaccination immunogenicity measures and no major protocol violations that were determined to potentially interfere with the immunogenicity assessment of the study vaccine. This was decided before unblinding."|||Titer||95% Confidence Interval|Geometric Mean
2545900|NCT02935192|Primary|Geometric Mean Titers (GMTs) of Serum HAI Antibodies|Serum HAI Antibodies GMTs Pre- (Day 1) and Post-vaccination (Day 22); measured for each of the 3 antigens|Day 1 and Day 22|"Per Protocol (PP) Population:~Immunogenicity was assessed in a subset of 151 participants (per-protocol population) with valid post-vaccination immunogenicity measures and no major protocol violations that were determined to potentially interfere with the immunogenicity assessment of the study vaccine. This was decided before unblinding."|||Titer||95% Confidence Interval|Geometric Mean
2545901|NCT02935192|Primary|Number and Percentage of Participants With a HAI Antibody Titer ≥1:40 (Seroprotection)|Seroprotective Titers is considered as HAI antibody Titre ≥1:40; measured for each of the 3 antigens|Day 1 and Day 22|"Per Protocol (PP) Population:~Immunogenicity was assessed in a subset of 151 participants (per-protocol population) with valid post-vaccination immunogenicity measures and no major protocol violations that were determined to potentially interfere with the immunogenicity assessment of the study vaccine. This was decided before unblinding."|||Participants|||Count of Participants
2545902|NCT02935192|Primary|Number and Percentage of Seroconverted Subjects|"Seroconversion is defined as a serum HAI antibody titer meeting the following criteria:~Pre-vaccination titer <1:10 and a post-vaccination titer measured on Day 22 of ≥1:40; or~Pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination measured on Day 22.~Measured against each of the 3 antigens"|Day 22|"Per Protocol (PP) Population:~Immunogenicity was assessed in a subset of 151 participants (per-protocol population) with valid post-vaccination immunogenicity measures and no major protocol violations that were determined to potentially interfere with the immunogenicity assessment of the study vaccine. This was decided before unblinding."|||Participants|||Count of Participants
2545903|NCT02935192|Primary|Number of Participants With Serious Adverse Events (SAE)|Number of participants reporting one or more of all anticipated and unanticipated serious adverse events, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.|Over the entire study period (Day 91)|Full Analysis Population|||Participants|||Count of Participants
2545904|NCT02935192|Primary|Number of Participants With Unsolicited Adverse Events|Unsolicited AEs occurring in 1% or more of study participants; includes events irrespective of causality|Within 21 days post vaccination|Full analysis population|||Participants|||Count of Participants
2545905|NCT02935192|Primary|Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity)|Number of subjects reporting one or more solicited systemic reactions (fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache) post-vaccination with study vaccine or placebo.|5-day period (Days 1-5) post-vaccination|Full analysis population|||Participants|||Count of Participants
2545910|NCT02935088|Other Pre-specified|Correlation of Other PressureWire-derived Index, Contrast FFR With FFR Values|Linear correlation of FFR and contrast FFR (cFFR). Only subjects that had both FFR and cFFR were used in the analysis.|at time of procedure|The number of participants and lesions analyzed were based on the number of participants underwent both FFR and cFFR measurements for this Outcome Measure|||correlation coefficient|Lesion||Number
2545911|NCT02935088|Other Pre-specified|Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR)|"Number of subjects with 12-month clinical outcomes (MACE) by other PressureWire-derived indices (contrast FFR).~Major adverse cardiac events (MACE) is defined as a 12-month composite, including all cause death, documented non-fatal myocardial infarction, and unplanned hospitalization leading to urgent revascularization."|12 months|The denominators used in the calculations of adverse event rates will be determined according to the analysis population excluding subjects who are lost to follow-up through given time point without events.|||Participants|||Count of Participants
2545912|NCT02935088|Other Pre-specified|Number of Subjects With 12-Month Clinical Outcomes (MACE) Major Adverse Cardiac Events of Follow-up Subjects in Whom the Use of FFR Did Not Lead to a Change in Treatment Decision vs Subjects in Whom the Use of FFR Led to a Change in Treatment Decision|Number of subjects with 12-Month Clinical Outcomes (MACE) Major Adverse Cardiac Events of Follow-up subjects in whom the use of FFR did not lead to a change in treatment decision vs subjects in whom the use of FFR led to a change in treatment decision.|12 months|The denominators used in the calculations of adverse event rates will be determined according to the analysis population excluding subjects who are lost to follow-up through given time point without events.|||Participants|||Count of Participants
2545913|NCT02935088|Other Pre-specified|Number of Subjects Who Had a Change in Treatment Plan When FFR is Used Compared to the Initial Decision Based on Angiography Alone|"Treatment decision was defined as changed if there is at least one decision change based on FFR for multiple lesions; if none of the decisions was changed for the multiple lesions, the treatment decision is defined as unchanged."|at time of procedure||||Participants|||Count of Participants
2545914|NCT02935088|Other Pre-specified|Correlation of Resting Indices With FFR Values|Linear correlation will be used for continuous variables to examine agreement between FFR values and resting indices.|at time of procedure|The number of participants and lesions analyzed were based on the number of participants underwent both FFR and Pd/Pa measurements for this Outcome Measure|||correlation coefficient|Lesion||Number
2545915|NCT02935088|Primary|Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices|"Major adverse cardiac events (MACE) is defined as a 12-month composite, including all cause death, documented non-fatal myocardial infarction, and unplanned hospitalization leading to urgent revascularization.~Fisher Exact test will be performed to evaluate the association between 12-month MACE event and binary FFR variables respectively using the following FFR; Low FFR group (FFR ≤ 0.8) and high FFR group (FFR > 0.8)."|12 months|The denominators used in the calculations of adverse event rates will be determined according to the analysis population excluding subjects who are lost to follow-up through given time point without events.|||Participants|||Count of Participants
2545916|NCT02935062|Primary|P300- Long-latency Auditory Evoked Potential|"Electrophysiological evaluation of the auditory pathway through the protocol, Pretreatment and Post-treatment P300 waves were analyzed by the latency according to the parameters of MacPherson (1996).~The electrophysiological protocol was performed before and after therapy. The marking of the waves was judged by specialist judges in the field of audiology.~The variable that predicts P300 latency is quantified in milliseconds (ms"|10 weeks.|The same sample was evaluated with this P300 variable, quantified in milliseconds (ms), which corresponds to the P300 electrophysiological wave latency.|||(ms) milliseconds||Standard Deviation|Mean
2545917|NCT02935062|Primary|Percentage of Consonants Correct (PCC) Pre-treatment and Post-treatment Phonological Instrument|The percentage of correct consonants corresponds to the number of phonemes produced by the child, evaluated initially before starting treatment and at the end of treatment. The variable of this calculation is based on the percentage which is determined at what phonological level of disorder the child is at. It is expected that at the end of treatment the percentage of correct consonants will increase due to the therapy stimuli offered.|10 weeks|The population is described by the age and using the variables of PCC, phonemes acquired The numbers shows the meand and standard deviation after the treatment.|||PCC - (%)||Standard Deviation|Mean
2545918|NCT02935036|Primary|"The Percentage of Subjects With a Clinical Response (IGA) of Success at Week 12 on the Face."|Success was defined as an IGA score that was at least two grades less than the baseline assessment.|Baseline to Week 12 (study day 84)|The analysis population for efficacy excluded some subjects in baseline/randomized population.|||Percentage of subjects|||Number
2545919|NCT02935036|Primary|Percent Change From Baseline to Week 12 in the Non-inflammatory (Open and Closed Comedones) Lesion Counts on the Face||Baseline to week 12 (study day 84)|The analysis population for efficacy excluded some subjects in baseline/randomized population.|||percentage change in lesion counts||95% Confidence Interval|Least Squares Mean
2545920|NCT02935036|Primary|Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts on the Face||Baseline to week 12 (study day 84)|The analysis population for efficacy excluded some subjects in baseline/randomized population.|||percentage change in lesion counts||95% Confidence Interval|Least Squares Mean
2545921|NCT02934932|Secondary|Change in CAPS-5 Ratings Score|Determine the effect of brexpiprazole therapy on PTSD symptom severity|Baseline to 6 weeks for each treatment arm|Data not collected.||||||
2545922|NCT02934932|Primary|Change in Resting Pupil Diameter|Evaluate the effects of two doses of brexpiprazole on locus coeruleus (LC) norepinephrine (NE) neuron activity.|Baseline to 6 weeks for each treatment arm|Data not collected.||||||
2545923|NCT02934698|Secondary|Sweat Chloride|Testing efficacy through gathering absolute change in sweat chloride from baseline through week 24|24 Weeks||||mmol/L||Full Range|Mean
2545924|NCT02934698|Secondary|Sputum Results|Achievement of mycobacterial culture conversion (negative culture)|24 weeks||||Participants|||Count of Participants
2545925|NCT02934698|Primary|Forced Expiratory Volume|Absolute change in percent predicted in 1 second FEV1 from baseline through week 24|24 weeks||||percentage of predicted||Full Range|Mean
2550644|NCT02829944|Secondary|Number of Subjects Experiencing Nausea|Asking patients whether or not they experienced the symptom in the preceding time-frame|48 hours||||Participants|||Count of Participants
2545926|NCT02934347|Secondary|The Time Between the Beginning of Laryngoscopy and Detection of Carbon Dioxide on the End-tidal Carbon Dioxide Monitor|The time between the beginning of laryngoscopy and detection of carbon dioxide on the end-tidal carbon dioxide monitor after the successful placement of the tracheal tube was recorded|Once at intubation|Adult patients who required intubation as part of their routine anaesthesia|||seconds||Inter-Quartile Range|Median
2545927|NCT02934347|Secondary|The Use of Ancillary Equipment|The use of ancillary equipment (e.g. bougie, alternative laryngoscope blades) and manoeuvres (e.g. laryngeal manipulation) were recorded but applied at the intubating anaesthetist's discretion|Once at intubation|Adult patients who required intubation as part of their routine anaesthesia|||participants|||Number
2545928|NCT02934347|Secondary|The Number of Attempts at Both Laryngoscopy and Tracheal Intubation|The number of attempts at both laryngoscopy and tracheal intubation were recorded|Once at intubation|Adult patients who required intubation as part of their routine anaesthesia|||participants|||Number
2545929|NCT02934347|Primary|The Best Glottic View Obtained During Laryngoscopy|"The best glottic view obtained during laryngoscopy was assessed using the Cormack and Lehane classification by the anaesthetist performing the laryngoscopy.~The Cormack and Lehane classifies glottic views as follows: Grade 1: Most of the glottis is visible, Grade 2: At best almost half of the glottis is seen, at worst only the posterior tip of the arytenoids is seen., Grade 3: Only the epiglottis is visible, Grade 4: No laryngeal structures are visible."|The view of the glottis was measured once while the patient was being intubated|Adult patients who required intubation as part of their routine anaesthesia|||participants|||Number
2545930|NCT02934191|Primary|Difference in Amount of Rescue Pain Medication Consumed|The total amount of rescue pain medication consumed in the 2-week postop period will be compared between the two treatment groups.|2 weeks post-operative|Subjects with evaluable data|||mg/kg||Standard Deviation|Mean
2545931|NCT02934191|Primary|Difference in Number of Days Requiring Rescue Pain Medication|The number of days on narcotic pain medication following surgery will be compared between the two treatment groups|2 weeks post-operative|Subjects with evaluable data|||Days||Standard Deviation|Mean
2545932|NCT02934178|Secondary|Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen||Days 7, 28, 35, 56, 63, and 84|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||Participants|||Count of Participants
2545933|NCT02934178|Secondary|Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen||Days 7, 28, 35, 56, 63, and 84|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||Participants|||Count of Participants
2545934|NCT02934178|Secondary|Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen||Baseline (Day 0, pre-vaccination) and Days 7, 28, 35, 56, 63, and 84|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||fold change||95% Confidence Interval|Geometric Mean
2545935|NCT02934178|Secondary|Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigens||Baseline (Day 0, pre-vaccination) and Days 7, 28, 35, 56, 63, and 84|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||fold change||95% Confidence Interval|Geometric Mean
2545936|NCT02934178|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen|The mucosal immune response to the WRSS1 was evaluated by assessing fecal IgA antibody responses to S. sonnei LPS in ELISA assays at Days 0, 7, 28, 35, 56, 63, and 84.|Days 0, 7, 28, 35, 56, 63, and 84|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||titer||95% Confidence Interval|Geometric Mean
2545937|NCT02934178|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen|The mucosal immune response to the WRSS1 was evaluated by assessing fecal IgA antibody responses to S. sonnei Invaplex in ELISA assays at Days 0, 7, 28, 35, 56, 63, and 84. Invaplex is a mixture of purified S. sonnei LPS and purified protein antigens IpaB and IpaC.|Days 0, 7, 28, 35, 56, 63, and 84|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||titer||95% Confidence Interval|Geometric Mean
2545938|NCT02934178|Secondary|Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen||Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||Participants|||Count of Participants
2545939|NCT02934178|Secondary|Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen||Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||Participants|||Count of Participants
2545940|NCT02934178|Secondary|Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Lipopolysaccharide (LPS) Antigen||Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||Participants|||Count of Participants
2545941|NCT02934178|Secondary|Count of Participants With 4-fold Rise in Immunoglobulin M (IgM) Antibodies in Serum From Baseline: Invaplex Antigen||Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||Participants|||Count of Participants
2545942|NCT02934178|Secondary|Count of Participants With 4-fold Rise in Immunoglobulin G (IgG) Antibodies in Serum From Baseline: Invaplex Antigen||Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||Participants|||Count of Participants
2545943|NCT02934178|Secondary|Count of Participants With 4-fold Rise in Immunoglobulin A (IgA) Antibodies in Serum From Baseline: Invaplex Antigen||Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||Participants|||Count of Participants
2545944|NCT02934178|Secondary|Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen||Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||fold change||95% Confidence Interval|Geometric Mean
2545945|NCT02934178|Secondary|Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Serum : Invaplex Antigen||Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||fold change||95% Confidence Interval|Geometric Mean
2545946|NCT02934178|Secondary|Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS)||Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||fold change||95% Confidence Interval|Geometric Mean
2545947|NCT02934178|Secondary|Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen||Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||fold change||95% Confidence Interval|Geometric Mean
2545948|NCT02934178|Secondary|Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen||Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||fold change||95% Confidence Interval|Geometric Mean
2545949|NCT02934178|Secondary|Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens||Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||fold change||95% Confidence Interval|Geometric Mean
2545950|NCT02934178|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen|The systemic immune response to WRSS1 was evaluated by assessing the IgM antibody response to S. sonnei 2a LPS in serum/plasma samples at Days 0, 7, 35 and 63. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates.|Days 0, 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||titer||95% Confidence Interval|Geometric Mean
2545951|NCT02934178|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Serum: Invaplex Antigen|The systemic immune response to WRSS1 was evaluated by assessing the IgM antibody response to S. sonnei Invaplex in serum/plasma samples at Days 0, 7, 35 and 63. Invaplex is a mixture of purified S. sonnei LPS and purified protein antigens IpaB and IpaC. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates.|Days 0, 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||titer||95% Confidence Interval|Geometric Mean
2545952|NCT02934178|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS)|The systemic immune response to WRSS1 was evaluated by assessing the IgG antibody response to S. sonnei 2a LPS in serum/plasma samples at Days 0, 7, 35 and 63. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates.|Days 0, 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||titer||95% Confidence Interval|Geometric Mean
2545953|NCT02934178|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen|The systemic immune response to WRSS1 was evaluated by assessing the IgG antibody response to S. sonnei Invaplex in serum/plasma samples at Days 0, 7, 35 and 63. Invaplex is a mixture of purified S. sonnei LPS and purified protein antigens IpaB and IpaC. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the ELISA plates.|Days 0, 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||titer||95% Confidence Interval|Geometric Mean
2545954|NCT02934178|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen|The systemic immune response to WRSS1 was evaluated by assessing the IgA antibody response to S. sonnei 2a LPS in serum/plasma samples at Days 0, 7, 35 and 63. Serotype-specific lipopolysaccharide (LPS) from the Walter Reed Army Institute was used to coat the ELISA plates.|Days 0, 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||titer||95% Confidence Interval|Geometric Mean
2545955|NCT02934178|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigens|The systemic immune response to WRSS1 was evaluated by assessing the IgA antibody response to S. sonnei Invaplex in serum/plasma samples at Days 0, 7, 35 and 63. Invaplex is a mixture of purified S. sonnei LPS and purified protein antigens IpaB and IpaC. Serotype-specific LPS from the Walter Reed Army Institute was used to coat the enzyme-linked immunosorbent assay (ELISA) plates.|Days 0, 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||titer||95% Confidence Interval|Geometric Mean
2545956|NCT02934178|Secondary|Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen||Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||Participants|||Count of Participants
2545957|NCT02934178|Secondary|Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen||Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||Participants|||Count of Participants
2545958|NCT02934178|Secondary|Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen||Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||Participants|||Count of Participants
2545959|NCT02934178|Secondary|Count of Participants With 4-fold Rise From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen||Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||Participants|||Count of Participants
2545960|NCT02934178|Secondary|Count of Participants With 4-fold Rise From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen||Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||Participants|||Count of Participants
2545961|NCT02934178|Secondary|Count of Participants With 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen||Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||Participants|||Count of Participants
2545962|NCT02934178|Secondary|Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen||Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||fold change||95% Confidence Interval|Geometric Mean
2545963|NCT02934178|Secondary|Geometric Mean Fold Change From Baseline in Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen||Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||fold change||95% Confidence Interval|Geometric Mean
2545964|NCT02934178|Secondary|Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS)||Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||fold change||95% Confidence Interval|Geometric Mean
2545965|NCT02934178|Secondary|Geometric Mean Fold Change From Baseline in Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen||Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||fold change||95% Confidence Interval|Geometric Mean
2545966|NCT02934178|Secondary|Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen||Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||fold change||95% Confidence Interval|Geometric Mean
2545967|NCT02934178|Secondary|Geometric Mean Fold Change From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens||Baseline (Day 0, pre-vaccination) and Days 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||fold change||95% Confidence Interval|Geometric Mean
2545968|NCT02934178|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen|The mucosal immune response to WRSS1 was evaluated by assessing specific IgM antibody responses to S. sonnei LPS using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine LPS-specific IgM response from circulating lymphocytes.|Days 0, 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||titer||95% Confidence Interval|Geometric Mean
2545969|NCT02934178|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin M (IgM) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen|The mucosal immune response to WRSS1 was evaluated by assessing specific IgM antibody responses to S. sonnei Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine Invaplex-specific IgM response from circulating lymphocytes. Invaplex is a mixture of purified S. sonnei lipopolysaccharide (LPS) and purified protein antigens IpaB and IpaC.|Days 0, 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||titer||95% Confidence Interval|Geometric Mean
2545970|NCT02934178|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS)|The mucosal immune response to WRSS1 was evaluated by assessing specific IgG antibody responses to S. sonnei LPS using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine LPS-specific IgG response from circulating lymphocytes.|Days 0, 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||titer||95% Confidence Interval|Geometric Mean
2545971|NCT02934178|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigen|The mucosal immune response to WRSS1 was evaluated by assessing specific IgG antibody responses to S. sonnei Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine Invaplex-specific IgG response from circulating lymphocytes. Invaplex is a mixture of purified S. sonnei lipopolysaccharide (LPS) and purified protein antigens IpaB and IpaC.|Days 0, 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||titer||95% Confidence Interval|Geometric Mean
2545972|NCT02934178|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Lymphocyte Supernatant (ALS): Lipopolysaccharide (LPS) Antigen|The mucosal immune response to WRSS1 was evaluated by assessing specific IgA antibody responses to S. sonnei lipopolysaccharide (LPS) using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants from cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine LPS-specific IgA response from circulating lymphocytes.|Days 0, 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||titer||95% Confidence Interval|Geometric Mean
2545973|NCT02934178|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Antibody Lymphocyte Supernatant (ALS): Invaplex Antigens|The mucosal immune response to WRSS1 was evaluated by assessing specific IgA antibody responses to S. sonnei Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days (Days 0, 7, 35, and 63) to determine Invaplex-specific IgA response from circulating lymphocytes. Invaplex is a mixture of purified S. sonnei lipopolysaccharide (LPS) and purified protein antigens IpaB and IpaC.|Days 0, 7, 35, and 63|Subjects that received the vaccination on schedule and had sufficient sample to test the antigen were included.|||titer||95% Confidence Interval|Geometric Mean
2550645|NCT02829944|Secondary|Number of Subjects Experiencing Nausea|Asking patients whether or not they experienced the symptom in the preceding time-frame|24 hours||||Participants|||Count of Participants
2545974|NCT02934178|Primary|Number of Participants With Adverse Events Occurring Within 28 Days After Any Vaccination by Maximum Severity|"All toddlers were monitored for the occurrence of any adverse event (AE) or serious adverse event (SAE). Toddlers visited the clinic for safety assessments approximately one month after each vaccination.~Grades are based on maximum severity per participant."|Up to 28 days after any vaccination (up to Day 84)|Safety population|||Participants|||Count of Participants
2545975|NCT02934178|Primary|Maximum Severity of Reactogenicity by Vaccination|All toddlers were monitored for evidence of immediate reactions, assessed for systemic reactogenicity (fever, irritability, decreased appetite, and decreased activity) and gastrointestinal (GI) symptoms (abdominal pain, nausea, vomiting, loose stool, diarrhea, dysentery, bloating, excess flatulence, constipation) during the 72 hours following each vaccine dose.|72 hours after each vaccination (Day 3, Day 31, Day 59)||||Participants|||Count of Participants
2545976|NCT02933879|Secondary|Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure|Satisfactory clinical cure is defined as <5% of the target toenail involvement.|Day 141|Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 19 subjects from Group A+B and 9 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.|||Participants|||Count of Participants
2545977|NCT02933879|Secondary|Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure|Satisfactory clinical cure is defined as <5% of the target toenail involvement.|Day 281|Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 24 subjects from Group A+B and 15 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.|||Participants|||Count of Participants
2545978|NCT02933879|Secondary|Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure|Satisfactory clinical cure is defined as <5% of the target toenail involvement.|day 365|1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis.|||Participants|||Count of Participants
2545979|NCT02933879|Secondary|Number of Patients in Each Treatment Group With a Complete Clinical Cure|Complete clinical cure is defined as 0% nail involvement.|Day 141|Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 19 subjects from Group A+B and 9 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.|||Participants|||Count of Participants
2545980|NCT02933879|Secondary|Number of Patients in Each Treatment Group With a Complete Clinical Cure|Complete clinical cure is defined as 0% nail involvement.|Day 281|Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 24 subjects from Group A+B and 15 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.|||Participants|||Count of Participants
2545981|NCT02933879|Secondary|Number of Patients in Each Treatment Group With a Complete Clinical Cure|Complete clinical cure is defined as 0% nail involvement.|day 365|1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis.|||Participants|||Count of Participants
2545982|NCT02933879|Secondary|Number of Patients in Each Treatment Group With a Mycological Cure|Mycological cure is defined as a negative KOH test and a negative fungal culture.|Day 141|Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 20 subjects from Group A+B and 10 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.|||Participants|||Count of Participants
2545983|NCT02933879|Secondary|Number of Patients in Each Treatment Group With a Mycological Cure|Mycological cure is defined as a negative KOH test and a negative fungal culture.|day 365|1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis.|||Participants|||Count of Participants
2545984|NCT02933879|Secondary|Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure|Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail|Day 141|Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 19 subjects from Group A+B and 9 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.|||Participants|||Count of Participants
2545985|NCT02933879|Secondary|Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure|Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail|Day 365|1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis.|||Participants|||Count of Participants
2545986|NCT02933879|Primary|Number of Patients in Each Treatment Group With a Complete Therapeutic Cure|Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail|Day 141|Groups A and B were combined to compare against Group C to determine statistically significant difference when combining both groups that received test treatment in the first 56 Days vs only placebo. 19 subjects from Group A+B and 9 from Group C were excluded because they had no efficacy data or they lacked positive mycological cultures.|||Participants|||Count of Participants
2546301|NCT02927431|Secondary|Time to Improved Systolic Blood Pressure (SBP)|Time from first dose of treatment to time of SBP at >=90 millimeters of mercury (mmHg) was to be evaluated.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
2545987|NCT02933879|Primary|Number of Patients in Each Treatment Group With a Complete Therapeutic Cure|Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail|Day 365|1 Subject from Group B and 1 Subject from Group C were excluded from Efficacy Analysis because they did not have positive mycological culture screenings. Also, 12 subjects from Group A, 13 from Group B, and 14 from Group C were excluded because they had no efficacy data for the relevant analysis.|||Participants|||Count of Participants
2545988|NCT02933866|Primary|Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Success|Clinical Success is defined by an IGA score of 0 (clear) or I (almost clear) with at least a 2 grades reduction from baseline at Day 29 ± 2|Day 29||||Participants|||Count of Participants
2545989|NCT02933528|Primary|Proportion of Patients in the Study With HPA Axis Suppression|Hypothalamic Pituitary Adrenal (HPA) Axis Response to stimulation|28 days||||Participants|||Count of Participants
2545990|NCT02933502|Primary|Number of Participants With HPA Axis Suppression|Hypothalamic Pituitary Adrenal (HPA) Axis Response to stimulation|day 28|Two patients who had normal adrenal function at baseline, used at least 21 doses of the study product, and had data from a post-treatment cortisol response test were included in the analysis. One patient was excluded from the analysis of HPA axis suppression owing to abnormal adrenal function at baseline.|||Participants|||Count of Participants
2545991|NCT02933476|Secondary|Gait Asymmetry|Using data collected from inertial measurement unit (IMU) sensors on subject, we were able to measure gait asymmetry. For each subject, the swing time (SW) was calculated and averaged across strides for the left and right legs (SWL and SWR). We obtained gait asymmetry using the following: 100 x /ln(SWR/SWL)/. 0 marks perfect symmetry and greater values higher asymmetry. There is no maximum limit.|1 Month|One out of the five patients was on medication so was excluded from analysis.|||arb.units||Standard Deviation|Mean
2545992|NCT02933476|Secondary|Root Mean Square Velocity|Using gyroscopes to track patient movement testing, root mean square velocity (Vrms) of of the wrist during repetitive wrist flexion extension task was obtained.|1 Month|One out of the five patients was on medication so was excluded from analysis.|||deg/s||Standard Deviation|Mean
2545993|NCT02933476|Secondary|Unified Parkinson's Disease Rating Scale, Part III|We used the motor portion of the Unified Parkinson's disease Rating Scale (UPDRS) and excluded rigidity and speech from the assessment. Overall range of the score for the motor portion (excluding rigidity and speech) range from 0 to 108, where 0= best possible outcome and 108= worst possible outcome.|1 Month||||units on a scale||Standard Deviation|Mean
2545994|NCT02933476|Primary|Number of Patients Reporting Any Adverse Effects|Questionnaire asks patients to record any adverse effects they experienced.|1 Month||||Participants|||Count of Participants
2545995|NCT02933450|Secondary|Tolerability of High Dose Patiromer in ESRD Patients on Hemodialysis in the Acute Setting.|adverse events will be recorded and compared between the 2 groups|6 hours||||Participants|||Count of Participants
2545996|NCT02933450|Primary|Efficacy of Patiromer in Reducing Serum Potassium|serial serum potassium levels will be graphed and compared between the 2 groups|6 hours||||mEq/L||95% Confidence Interval|Mean
2545997|NCT02933060|Other Pre-specified|Verbal Report of Insertion Site Pain Score at 60 Minutes|Pain at IV insertion site (0 = No Pain, 10 = Maximum Pain)|60 minutes||||units on a scale (0-10)||Standard Deviation|Mean
2545998|NCT02933060|Secondary|Percentage of Patients Reporting no Nausea or Mild Nausea at 60 Minutes|Patients reporting no nausea or mild nausea|60 mins||||percentage of participants|||Number
2545999|NCT02933060|Secondary|Verbal Pain Score at 48 Hours|Current pain as reported by participants at 48 hour follow-up (0-10 verbal scale; 0 = No Pain, 10 = Maximum Pain).|48 hours||||units on a scale (0-10)||Standard Deviation|Mean
2546000|NCT02933060|Secondary|Length of Stay|Length of emergency department stay|1 day||||minutes||Standard Deviation|Mean
2546001|NCT02933060|Secondary|Percentage of Patients Who Needed Rescue Medications|Need for additional medications for pain control as determined by the treating physician.|120 minutes||||percentage of participants|||Number
2546002|NCT02933060|Secondary|Percentage of Patients Who Would Want the Same IV Fluid Treatment on a Future Visit|"Percentage of participants answering yes to the question: The next time you visit the ED with a headache, would you wish to receive the same IV fluid treatment again?"|48 hours||||percentage of participants|||Number
2546003|NCT02933060|Secondary|Percentage of Patients With no or Mild Functional Disability Due to Headache at 60 Minutes|Percentage of patients with functional disability due to headache rated as none or mild (able to perform all activities of daily living, but with some difficulty) at 60 minutes|60 minutes||||percentage of participants|||Number
2546004|NCT02933060|Secondary|Percentage of Patients Free of Pain at 2 Hours|Percentage of patients in each group who are pain-free two hours after initiation of the study intervention.|120 minutes||||percentage of participants|||Number
2546005|NCT02933060|Secondary|Verbal Pain Score at 120 Minutes|The difference in verbal pain rating (0 = no pain, 10 = maximum pain) between the start of the study intervention and 2 hours later. The minimum clinically significant difference between treatment groups on the 0-10 verbal scale is 1.3.|120 minutes||||units on a scale (0-10)||95% Confidence Interval|Mean
2546006|NCT02933060|Primary|Verbal Pain Score at 60 Minutes|The primary outcome will be the difference in verbal pain rating (0 = no pain, 10 = maximum pain) between the start of the study intervention and one hour later, at completion of the intervention. The minimum clinically significant difference between treatment groups on the 0-10 verbal scale is 1.3.|60 minutes||||units on a scale (0-10)||95% Confidence Interval|Mean
2546007|NCT02933034|Secondary|Estimated Glomerular Filtration Rate (eGFR)|eGFR levels during MEMRI scan as a measure of manganese contrast reagent safety. eGFR is a measurement of kidney function. Normal reference range was considered to be >60 ml/min/1.73m^2 for this study.|Before and after MEMRI scan (up to 3 hours)|Participants who had both MEMRI and DEMRI scans are included in the analysis|||mL/min/1.73m^2||Standard Deviation|Mean
2546008|NCT02933034|Secondary|Creatinine|Creatinine levels during MEMRI scan as a measure of manganese contrast reagent safety. Creatinine is a measurement of kidney function. Normal reference range was considered to be 0.50-1.20 mg/dL for this study.|Before and after MEMRI scan (up to 3 hours)|Participants who had both MEMRI and DEMRI scans are included in the analysis|||mg/dL||Standard Deviation|Mean
2550646|NCT02829944|Secondary|Number of Subjects Experiencing Nausea|Asking patients whether or not they experienced the symptom in the preceding time-frame|2 hours||||Participants|||Count of Participants
2546009|NCT02933034|Secondary|Total Bilirubin|Total bilirubin levels during MEMRI scan as a measure of manganese contrast reagent safety. Total bilirubin is a measurement of liver function. Normal reference range was considered to be <1.4 mg/dL for this study.|Before and after MEMRI scan (up to 3 hours)|Participants who had both MEMRI and DEMRI scans are included in the analysis|||mg/dL||Standard Deviation|Mean
2546010|NCT02933034|Secondary|Alkaline Phosphatase (ALP)|ALP levels during MEMRI scan as a measure of manganese contrast reagent safety. ALP is a measurement of liver function. Normal reference range was considered to be <40-130 U/L for this study.|Before and after MEMRI scan (up to 3 hours)|Participants who had both MEMRI and DEMRI scans are included in the analysis|||U/L||Standard Deviation|Mean
2546011|NCT02933034|Secondary|Aspartate Aminotransferase (AST)|AST levels during MEMRI scan as a measure of manganese contrast reagent safety. AST is a measurement of liver function. Normal reference range was considered to be <40 U/L for this study.|Before and after MEMRI scan (up to 3 hours)|Participants who had both MEMRI and DEMRI scans are included in the analysis|||U/L||Standard Deviation|Mean
2546012|NCT02933034|Secondary|Alanine Aminotransferase (ALT)|ALT levels during MEMRI scan as a measure of manganese contrast reagent safety. ALT is a measurement of liver function. Normal reference range was considered to be <60 U/L for this study.|Before and after MEMRI scan (up to 3 hours)|Participants who had both MEMRI and DEMRI scans are included in the analysis|||U/L||Standard Deviation|Mean
2546013|NCT02933034|Secondary|Corrected QT (QTc)|Corrected QT (QTc) interval during MEMRI scan as a measure of manganese contrast reagent safety. QTc is a measurement of heart function and is mainly used for diagnosis rather than QT, because QT is dependent on heart rate. Normal reference range was considered to be 360-450 milliseconds for this study.|Before and after MEMRI scan (up to 3 hours)|Participants who had both MEMRI and DEMRI scans are included in the analysis|||milliseconds||Standard Deviation|Mean
2546014|NCT02933034|Secondary|QT Interval|QT interval during MEMRI scan as a measure of manganese contrast reagent safety. QT is a measurement of heart function that is dependent on heart rate, so QTc is mainly used for diagnosis rather than QT. Normal reference range was considered to be 360-450 milliseconds for this study.|Before and after MEMRI scan (up to 3 hours)|Participants who had both MEMRI and DEMRI scans are included in the analysis|||milliseconds||Standard Deviation|Mean
2546015|NCT02933034|Secondary|Heart Rate|Heart rate during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 60 and 100 beats per minute.|Before,during, and after MEMRI scan (up to 3 hours)|Participants who had both MEMRI and DEMRI scans are included in the analysis|||beats per minute||Standard Deviation|Mean
2546016|NCT02933034|Secondary|Diastolic Blood Pressure|Diastolic blood pressure during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 60-80 mmHg.|Before,during, and after MEMRI scan (up to 3 hours)|Participants who had both MEMRI and DEMRI scans are included in the analysis|||mmHg||Standard Deviation|Mean
2546017|NCT02933034|Secondary|Systolic Blood Pressure|Systolic blood pressure during MEMRI scan as a measure of manganese contrast reagent safety. Normal reference range: 90-120 mmHg.|Before, during, and after MEMRI scan (up to 3 hours)|Participants who had both MEMRI and DEMRI scans are included in the analysis|||mmHg||Standard Deviation|Mean
2546018|NCT02933034|Primary|Infarct Size of MEMRI Versus DEMRI Scans|MEMRI is an assessment of non-viable myocardial tissue and evaluates core infarct size. DEMRI is an assessment of fibrotic tissue and evaluates the total infarct size. The difference between these two measurements evaluates the size of peri-infarct region consisting of mixed components of injured but viable cardiomyocytes and fibrosis.|Day of MEMRI and DEMRI scans (up to 3 hours per scan, performed on the same day or up to 7 days apart)|Participants who had both MEMRI and DEMRI scans are included in the analysis|||percentage of left ventricle||Standard Deviation|Mean
2546019|NCT02932943|Secondary|Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population|The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.|Baseline and Day 8|The baseline population for placebo non-responders is 292. One participant was randomized but not treated.|||Score on a Scale||Standard Error|Least Squares Mean
2546020|NCT02932943|Secondary|Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population|The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.|Baseline and Day 21|The baseline population for placebo non-responders is 292. One participant was randomized but not treated.|||Score on a Scale||Standard Error|Least Squares Mean
2546021|NCT02932943|Secondary|Change From Baseline in MADRS Total Score|The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.|Baseline and Day 8|The modified Intent-to-Treat (mITT) Population will consist of all patients who were randomized, received at least 1 dose of IP during the randomized treatment period, and had at least 1 post-randomization assessment of the MADRS total score.|||Score on a Scale||Standard Error|Least Squares Mean
2546041|NCT02932306|Secondary|Percent Change From Baseline in Noninflammatory Lesion Count to Week 12|Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.|Baseline, Week 12|ITT population included all randomized participants who received study drug. Multiple imputation (MCMC) was used to impute missing values.|||percent change||Standard Deviation|Least Squares Mean
2546022|NCT02932943|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Trial|The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.|Baseline and 3 Weeks|The modified Intent-to-Treat (mITT) Population will consist of all patients who were randomized, received at least 1 dose of IP during the randomized treatment period, and had at least 1 post-randomization assessment of the MADRS total score.|||Score on a Scale||Standard Error|Least Squares Mean
2546023|NCT02932904|Primary|Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 2 (mFAS2)|The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.|Baseline and Week 5|mFAS2 included all participants in the FAS except those who had drug concentrations BLOQ at any study visit where PK samples were collected.|||score on a scale||Standard Error|Least Squares Mean
2546024|NCT02932904|Primary|Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Modified Full Analysis Set 1 (mFAS1)|The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.|Baseline and Week 5|mFAS1 included all participants in the FAS except those who had active drug concentrations below the limit of quantification (BLOQ) at all study visits where pharmacokinetic (PK) samples were collected.|||score on a scale||Standard Error|Least Squares Mean
2546025|NCT02932904|Secondary|Change From Baseline in CSFQ-14 3 Phases of the Sexual Response Cycle (Desire, Arousal, and Orgasm/Completion) at Weeks 1, 2, 3, 4 and 5|The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning on the 3 phases of the sexual response cycle , desire (5 items, score range 5-25), arousal (3 items, score range 3-15), and orgasm (3 items, score range 3-15), rated on a 5-point scale from 1 to 5. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.|Baseline and Weeks 1, 2, 3, 4 and 5|FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Missing values were imputed by using LOCF. Here, number analyzed are the participants who were evaluated for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2546026|NCT02932904|Secondary|Change From Baseline in CSFQ-14 Subscales 5 Dimensions at Weeks 1, 2, 3, 4 and 5|The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning on the subscales of pleasure (1 item, score range 1-5), desire/frequency (2 items, score range 2-10), desire/interest (3 items, score range 3-15), arousal (3 items, score range 3-15), and orgasm (3 items, score range 3-15), rated on a 5-point scale from 1 to 5. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.|Baseline and Weeks 1, 2, 3, 4 and 5|FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Missing values were imputed by using LOCF. Here, number analyzed are the participants who were evaluated for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2546027|NCT02932904|Secondary|Percentage of Participants Meeting Criteria for Sexual Dysfunction at Weeks 1, 2, 3, 4 and 5|Sexual dysfunction is defined as CSFQ-14 score ≤47 for men and ≤41 for women.|Weeks 1, 2, 3, 4 and 5|FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Missing values were imputed by using LOCF. Here, number analyzed are the participants who were evaluated for this outcome measure.|||percentage of participants|||Number
2546028|NCT02932904|Secondary|Change From Baseline in CSFQ-14 Total Score Difference for Vortioxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5|The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.|Baseline and Weeks 1, 2, 3, 4 and 5|FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Here, number analyzed are the participants who were evaluated for this outcome measure in the FAS.|||score on a scale||Standard Error|Least Squares Mean
2546042|NCT02932306|Primary|Percentage of Participants With Treatment Success at Week 12|"Treatment success was defined as at least a 2-grade reduction from Baseline in EGSS score and an EGSS score equating to Clear or Almost Clear. EGSS was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe."|Baseline, Week 12|ITT population included all randomized participants who received study drug and evaluable for EGSS score. Multiple imputation (MCMC) was used to impute missing values. 1 participant was excluded from analysis of dichotomized EGSS because EGSS was not performed at baseline.|||percentage of participants|||Number
2546029|NCT02932904|Secondary|Change From Baseline in CSFQ-14 Total Score Difference for Paroxetine Versus Placebo at Weeks 1, 2, 3, 4 and 5|The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.|Baseline and Weeks 1, 2, 3, 4 and 5|FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Here, number analyzed are the participants who were evaluated for this outcome measure in the FAS.|||score on a scale||Standard Error|Least Squares Mean
2546030|NCT02932904|Secondary|Change From Baseline in the CSFQ-14 Total Score Difference for Vortioxetine Versus Paroxetine at Weeks 1, 2, 3 and 4|The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.|Baseline and Weeks 1, 2, 3 and 4|FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint. Here, number analyzed are the participants who were evaluated for this outcome measure in the FAS.|||score on a scale||Standard Error|Least Squares Mean
2546031|NCT02932904|Primary|Change From Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score Difference for Vortioxetine Versus Paroxetine at Week 5 in Full Analysis Set (FAS)|The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), orgasm (3 items) and 2 additional items are included in the total score, but do not map to a specific phase of the sexual response cycle, rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A negative change from baseline indicates that symptoms have worsened.|Baseline and Week 5|FAS included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid postbaseline value for assessment of primary endpoint.|||score on a scale||Standard Error|Least Squares Mean
2546032|NCT02932891|Primary|The Number of Patients in the Study With HPA Axis Suppression|Hypothalamic Pituitary Adrenal (HPA) Axis Response to a stimulator|29 Days||||Participants|||Count of Participants
2546033|NCT02932878|Primary|Proportion of Patients in the Study With HPA Axis Suppression|Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin|28 Days|The one patient in Cohort 2 did not qualify for evaluation of HPA axis suppression.|||Participants|||Count of Participants
2546034|NCT02932787|Secondary|Change in Workplace Presenteeism Using the World Health Organisation Health and Work Performance Questionnaire|Self-reported absolute presenteeism (an employees productivity during working hours) measured using the World Health Organisation Health and Work Performance Questionnaire. The higher the percentage, the more productive a participant felt they were. 100% means that they felt they were productive the whole time they were working. Presenteeism can be impacted upon by illness and other health conditions, if a person was feeling ill or had a back problem, this may mean that they are less productive whilst at work.|Baseline (0 weeks), 4 weeks after installation of height-adjustable workstations||||Percentage of job able to perform||Full Range|Median
2546035|NCT02932787|Secondary|Change in Workplace Absenteeism Using the World Health Organisation Health and Work Performance Questionnaire|Self-reported absolute absenteeism (the amount of time a participant was absent from work for during the previous 7-days) measured using the World Health Organisation Health and Work Performance Questionnaire. This is calculated in relation to a participants contracted hours, therefore a negative score shows that a participant worked less than they are contracted to, where as a positive score means a participant reported working more hours than they are contracted to.|Baseline (0 weeks), 4 weeks after installation of height-adjustable workstations||||Hours worked in last 7-days||Full Range|Median
2546036|NCT02932787|Primary|Change in Workplace Sedentary Time|The amount of time a participant spends sitting whilst in the workplace (minutes). This was measured using a thigh-worn ActivPAL accelerometer.|Baseline (0 weeks), 4 weeks after installation of height-adjustable workstations||||Minutes||Standard Deviation|Mean
2546037|NCT02932462|Secondary|Clinical Success in Patients With Mild Scalp Psoriasis|IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline|from baseline to study day 29||||Participants|||Count of Participants
2546038|NCT02932462|Primary|Clinical Success in Patients With Mild to Severe Scalp Psoriasis|IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline|from baseline to study day 29|Patients with mild to severe scalp psoriasis (primary analysis 2)|||Participants|||Count of Participants
2546039|NCT02932462|Primary|Clinical Success in Patients With Moderate and Severe Scalp Psoriasis|IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline|from baseline to study day 29|Patients with moderate and severe scalp psoriasis (primary analysis 1)|||Participants|||Count of Participants
2546040|NCT02932306|Secondary|Percent Change From Baseline in Inflammatory Lesion Count to Week 12|Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.|Baseline, Week 12|ITT population included all randomized participants who received study drug. Multiple imputation (MCMC) was used to impute missing values.|||percent change||Standard Deviation|Least Squares Mean
2550647|NCT02829944|Secondary|Time to First Rescue Analgesic||48 hours||||Minutes||Inter-Quartile Range|Mean
2550648|NCT02829944|Secondary|Opioid Consumption|measured in mg oxycodone equivalents|48 hours||||mg Oxycodone Equivalent||Inter-Quartile Range|Mean
2546043|NCT02932306|Primary|Absolute Change From Baseline in Mean Inflammatory Lesion Count to Week 12|Inflammatory lesions were defined as follows: Papule - a solid, elevated lesion less than 5 millimeters (mm); and Pustule - an elevated lesion containing pus less than 5 mm. For inflammatory facial lesions, papules and pustules were recorded as a single count, while nodular lesions were counted and recorded separately.|Baseline, Week 12|ITT population included all randomized participants who received study drug. Multiple imputation (MCMC) was used to impute missing values.|||lesion count||Standard Deviation|Least Squares Mean
2546044|NCT02932306|Primary|Absolute Change From Baseline in Mean Noninflammatory Lesion Count to Week 12|Noninflammatory lesions were defined as follows: Open comedones (blackhead) - plugged hair follicle with dilated/open orifice, black in color; and Closed comedones (whitehead) - plugged hair follicle: small opening at skin surface. For noninflammatory facial lesions, open and closed comedones were recorded as a single count.|Baseline (Day 0), Week 12|ITT population included all randomized participants who received study drug. Multiple imputation (Markov Chain Monte Carlo [MCMC]) was used to impute missing values.|||lesion count||Standard Deviation|Least Squares Mean
2546045|NCT02932267|Primary|Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire|% of subjects satisfied to very satisfied with study treatment at week 12|At week 12|Intent-to-treat (ITT) population. Here 'N' (number analyzed) signifies number of participants evaluable for this outcome measure.|||Participants|||Count of Participants
2546046|NCT02932228|Other Pre-specified|Functional Status (Patient-reported)|We will assess changes in patient-reported functional status through a patient survey administered at time of enrollment and 4-9 months after enrollment. The outcome measure includes percentage of patients(from 0-100%) who indicated having some difficulty, much difficulty, or inability to perform tasks due to functional limitations. A higher score indicates more functional limitations|9 months|The survey was only given to ImPACT enrollees.|||percentage of participants|||Number
2546047|NCT02932228|Other Pre-specified|Symptom Burden (Patient-reported)|"We will assess changes in patient-reported symptom burden, including pain through a patient survey administered at time of enrollment and 4-9 months after enrollment. Outcome measure below is the mean number of participants who rate their pain in the last weeks on a 10 point scale where 0=None and 10=severe pain, a higher value indicates worse symptom burden."|up to 9 months|The survey was only given to ImPACT enrollees.|||Units on a scale||Standard Deviation|Mean
2546048|NCT02932228|Other Pre-specified|Health Status (Patient-reported)|We will assess patient-reported health status through a patient survey administered at time of enrollment and 4-9 months after enrollment. Outcome measure includes mean patient activation scores between baseline and follow up survey periods. Activation is measured on a scale from 0-100, with higher numbers corresponding to higher levels of patient activation.|up to 9 months|This analysis was only conducted on the ImPACT group.|||units on a scale||Standard Deviation|Mean
2546049|NCT02932228|Other Pre-specified|Patient Satisfaction|"We will assess patient satisfaction with the ImPACT intervention and changes in satisfaction with overall care. The Patient Satisfaction Questionnaires ask:~Please describe your satisfaction with ImPACT Clinical Services~Medical care~Social work services~Recreational and community services~After-hours services~The 4 items were combined to create a mean overall satisfaction with ImPACT care score, which ranges from 1-4, 4 indicating better satisfaction with the program. The scale is measured on a 4 point scale with 1 meaning strongly disagree and 4 meaning strongly agree."|9 months|The survey was only given to ImPACT enrollees.|||units on a scale||Standard Deviation|Mean
2546050|NCT02932228|Other Pre-specified|Implementation Process|Interviews with ImPACT team members, PACT providers, and VA facility leadership will be used to understand the ImPACT program implementation process. Outcome measure is number of participants enrolled and completed interviews.|9 months|This analysis was only conducted on the ImPACT group.|||Participants|||Count of Participants
2546051|NCT02932228|Other Pre-specified|Feasibility: Participation|We will evaluate proportion of patients who participate in ImPACT and the frequency of their contact with ImPACT team members. Outcome measure is the average number of patient-ImPACT provider in person contacts per month from 2/2013-6/2014|9 months|This analysis was only conducted on the ImPACT group.|||encounters||Full Range|Mean
2546052|NCT02932228|Other Pre-specified|Feasibility: Time to Enrollment|To evaluate ImPACT's feasibility, we will assess time to enrollment for invited participants. Number is reported is number of participants still enrolled in ImPACT program after 9 months|9 months|This analysis was only conducted on the ImPACT group.|||participants|||Number
2546053|NCT02932228|Secondary|Outpatient Utilization|Number of visits to primary, specialty, and mental health clinics. Number reported is mean primary care visits between ImPACT and PACT.|17 months||||visits||Standard Deviation|Mean
2546054|NCT02932228|Secondary|Emergency Department Utilization|Number of Emergency Department visits|17 months||||visits||Standard Deviation|Mean
2546055|NCT02932228|Secondary|Hospitalization|Admission rates and length of stay of acute medical/surgical, acute mental health, extended medical, and extended mental health inpatient care. Outcome reported is mean(SD) number of hospital admissions using intent to treat analysis between both groups.|17 months||||Admissions||Standard Deviation|Mean
2546056|NCT02932228|Primary|VA Health Care Costs|Estimated programs effect on cost among all patients, and correspond to the change in monthly costs among patients in impact minus the change in costs for patients in PACT.|17 months|Program's effect on monthly person level costs|||US Dollars||Standard Deviation|Mean
2546057|NCT02931396|Primary|Change in Residual Limb Pain Using Likert Scale Pain Questionnaire|Scores were reported on a 0 to 10 scale with higher scores representing higher pain levels|baseline and 12 weeks||||units on a scale||95% Confidence Interval|Mean
2546058|NCT02931396|Primary|Change in Residual Limb Volume Using 3-D Scanner|3-D motion-tracking laser scanning system was used to determine residual limb volume in cm|baseline and 12 weeks||||cm||95% Confidence Interval|Mean
2546059|NCT02931396|Primary|Change in Knee Extension Isometric Strength (Peak Torque) Using the Biodex Measurement System|Residual limb knee extension isometric strength was tested using a standardized Biodex protocol and custom attachment. The lever arm of the Biodex was positioned at 60 degrees of knee flexion, with the support cushion modified for the amputee and positioned at the mid-tibia. The participant was asked to extend their knee against the arm as hard as they could for five seconds.|baseline and 12 weeks||||Nm/kg||95% Confidence Interval|Mean
2550649|NCT02829944|Secondary|Opioid Consumption|measured in mg oxycodone equivalents|24 hours||||mg Oxycodone Equivalent||Inter-Quartile Range|Median
2546060|NCT02930980|Primary|Waveform and Components of Accelerometer Signal|"Accelerometer signal was measured using the 3 axis Micra accelerometer (Vector 1 was labelled as V1, Vector 2 as V2, Vector 3 as V3).~Components of the accelerometer signals (unit (g) represent acceleration)were identified and labelled as A1 (acceleration associated with ventricular systole), A2 (ventricular diastole), A3 (early passive filling), and A4 (active filling). The A4 signal is associated with atrial contraction and active filling."|For approximately two hours after software download|Of the 43 subjects enrolled, 12 with Atrial tachycardia / Atrial fibrillation and 2nd degree or greater atrioventricular block were excluded from analysis since the A4 signal is absent or variable. An additional 4 subjects in sinus rhythm were excluded from analysis due to frequent pacing or telemetry noise, resulting in 27 subjects for analysis.|||g (unit (g) represent acceleration)||Standard Deviation|Mean
2546061|NCT02930837|Secondary|The Percentage of Patients With Incidence of Cerebral Herniation and Symptomatic Edema|The percentage of patients with incidence of cerebral herniation and symptomatic edema.|90 days|Treated Set|||Percentage of patients||95% Confidence Interval|Number
2546062|NCT02930837|Secondary|The Percentage of Patients With Severity of Adverse Events|The percentage of patients with severity of adverse events (AEs). The percentage of patients with different categories of AEs are presented.|On-treatment period, that is, within 7 days from the start of bolus|Treated Set|||Percentage of patients|||Number
2546063|NCT02930837|Secondary|The Percentage of Patients With Death Related to Stroke or of Neurological Causes|The percentage of patients with death related to stroke or of neurological causes.|90 days|Treated Set|||Percentage of patients||95% Confidence Interval|Number
2546064|NCT02930837|Secondary|Patient Survival Probability at Visit 5 (Censoring at Day 90)|Patient survival probability at visit 5 (censoring at day 90). The percentage of patients who died until Day 1, Day 7, Day 30, Day 90.|90 days|Treated Set|||Percentage of patients|||Number
2546065|NCT02930837|Primary|The Percentage of Patients With Symptomatic Intracranial Haemorrhage (sICH) Centrally Evaluated by Data-monitoring Committee (DMC) Consultants According to European Cooperative Acute Stroke Study (ECASS) III Definition Within the Whole Study Period|The percentage of patients with symptomatic intracranial haemorrhage (sICH) centrally evaluated by data-monitoring committee (DMC) consultants according to European Cooperative Acute Stroke Study (ECASS) III definition within the whole study period. According to the protocol, sICH (ECASS III criteria) was defined as: any apparently extravascular blood in the brain or within the cranium that was associated with clinical deterioration (defined by an increase in the NIHSS score of 4 or more points), or that led to death and that was identified as the predominant cause of the neurological deterioration. sICH event was firstly evaluated by investigator. The DMC consultants evaluated all the patients with NIHSS score increase of at least 4 any time after treatment (including all fatal patients and sICH events evaluated by investigator). Wilson score confidence interval is presented.|90 days|Treated Set|||Percentage of patients||95% Confidence Interval|Number
2546066|NCT02930837|Secondary|The Percentage of Global Outcome Responder at Day 90 if he/She Obtains the Following Results at Day 90 (for All of the 4 Endpoints) mRS Score of 0 to 1; Barthel Index Score >= 95; NIHSS Score of 0 to 1; Glasgow Outcome Scale Score of 1|Percentage of global outcome responder at day 90 if he/she obtains the following results at day 90 for the endpoints mRS score of 0 to 1; Barthel Index score >= 95; NIHSS score of 0 to 1; Glasgow Outcome Scale score of 1. mRS: 0 = no symptom at all, 1 = no significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability, and 6 = dead. NIHSS is composed of 11 items, and for each item a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. Glasgow Outcome Score applies to patients with brain damage allowing the objective assessment of their recovery in five categories: 1 Good Recovery, 2 Moderately Disabled, 3 Severely Disabled, 4 Vegetative State, 5 Dead. Barthel Index score to measure performance in activities of daily living with the scale ranging from 0 to 100. Global outcome response is the intersection of above four respective outcomes.|90 days|Treated Set, worst and last observation carried forward were used for the imputation of efficacy endpoints|||Percentage of patients||95% Confidence Interval|Number
2546067|NCT02930837|Primary|The Percentage of Patients With Modified Rankin Scale (mRS 0-1) (Favourable Outcome) Response at Day 90 After Stroke Onset by Face-to-face Interview With Patient|The percentage of patients with modified Rankin Scale (mRS 0-1) (favourable outcome) response at Visit 5 (Day 90) after stroke onset by face-to-face interview with patient. Modified Rankin Scale (mRS): 0 = no symptom at all, 1 = no significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability, and 6 = dead.|90 days|Treated Set, worst and last observation carried forward were used for the imputation of efficacy endpoints|||Percentage of patients|||Number
2546068|NCT02930590|Secondary|Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), After Two Hours Loading|The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm Diameter.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lay on every of the three types of mattress.|||proportion of the elastic recovery||Inter-Quartile Range|Median
2546069|NCT02930590|Secondary|Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), at Baseline|The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm Diameter.|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lay on every of the three types of mattress.|||proportion of the elastic recovery||Inter-Quartile Range|Median
2546070|NCT02930590|Secondary|Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), After Two Hours Loading|The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm Diameter.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||percentage of net elasticity||Inter-Quartile Range|Median
2550650|NCT02829944|Secondary|Opioid Consumption|measured in mg oxycodone equivalents|2 hours||||mg Oxycodone Equivalent||Inter-Quartile Range|Median
2546071|NCT02930590|Secondary|Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), at Baseline|The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm Diameter.|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||percentage of net elasticity||Inter-Quartile Range|Median
2546072|NCT02930590|Secondary|Skin Extensibility (Uf) in mm at the Sternum (Control- Area), After Two Hours Loading|Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm).|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||mm||Inter-Quartile Range|Median
2546073|NCT02930590|Secondary|Skin Extensibility (Uf) in mm at the Sternum (Control- Area), at Baseline|Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm).|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||mm||Inter-Quartile Range|Median
2546074|NCT02930590|Secondary|Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), After Two Hours Loading|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546075|NCT02930590|Secondary|Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), at Baseline|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546076|NCT02930590|Secondary|Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), After Two Hours Loading|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546077|NCT02930590|Secondary|Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), at Baseline|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546078|NCT02930590|Secondary|Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), After Two Hours Loading|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546079|NCT02930590|Secondary|Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), at Baseline|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546080|NCT02930590|Secondary|Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), After Two Hours Loading|Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||percentage of tissue water content||Inter-Quartile Range|Median
2546081|NCT02930590|Secondary|Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), at Baseline|Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||percentage of tissue water content||Inter-Quartile Range|Median
2546082|NCT02930590|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading|Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||arbitrary units||Inter-Quartile Range|Median
2546302|NCT02927431|Secondary|Time to Improved Heart Rate|Time from first dose of treatment to time of heart rate <=100 beats per minute was to be evaluated.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
2546083|NCT02930590|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), at Baseline|Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer.|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||arbitrary units||Inter-Quartile Range|Median
2546084|NCT02930590|Secondary|Erythema Index in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading|Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||arbitrary units||Inter-Quartile Range|Median
2546085|NCT02930590|Secondary|Erythema Index in Arbitrary Units at the Sternum (Control- Area), at Baseline|Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||arbitrary units||Inter-Quartile Range|Median
2546086|NCT02930590|Secondary|Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), After Two Hours Loading|Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||°C||Inter-Quartile Range|Median
2546087|NCT02930590|Secondary|Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), at Baseline|Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||°C||Inter-Quartile Range|Median
2546088|NCT02930590|Secondary|Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), After Two Hours Loading|TEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||g/m2/h||Inter-Quartile Range|Median
2546089|NCT02930590|Secondary|Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), at Baseline|TEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany)|at baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||g/m2/h||Inter-Quartile Range|Median
2546090|NCT02930590|Secondary|Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area)|Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546091|NCT02930590|Secondary|Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area)|Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).|baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546092|NCT02930590|Secondary|Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel|Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546093|NCT02930590|Secondary|Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel|Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).|baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546094|NCT02930590|Secondary|Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum|Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546095|NCT02930590|Secondary|Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum|Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546096|NCT02930590|Secondary|Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, 20 Minutes After Off-loading|Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).|20 minutes after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||percentage of tissue water content||Inter-Quartile Range|Median
2546097|NCT02930590|Secondary|Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, After Two Hours Loading|Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||percentage of tissue water content||Inter-Quartile Range|Median
2550651|NCT02829944|Secondary|Pain Scores at Rest|Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable|48 hours||||score on a scale||Inter-Quartile Range|Median
2546098|NCT02930590|Secondary|Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, at Baseline|Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||percentage of tissue water content||Inter-Quartile Range|Median
2546099|NCT02930590|Secondary|Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, 20 Minutes After Off-loading|Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).|20 minutes after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||percentage of tissue water content||Inter-Quartile Range|Median
2546100|NCT02930590|Secondary|Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, After Two Hours Loading|Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||percentage of tissue water content||Inter-Quartile Range|Median
2546101|NCT02930590|Secondary|Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, at Baseline|Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||percentage of tissue water content||Inter-Quartile Range|Median
2546102|NCT02930590|Secondary|Skin Elastic Function (Ur/Ue) at the Heel, 20 Minutes After Off-loading|The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm Diameter.|20 minutes after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||percentage of net elasticity||Inter-Quartile Range|Median
2546103|NCT02930590|Secondary|Skin Elastic Function (Ur/Ue) at the Heel, After Two Hours Loading|The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm Diameter.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||percentage of net elasticity||Inter-Quartile Range|Median
2546104|NCT02930590|Secondary|Skin Elastic Function (Ur/Ue) at the Heel, at Baseline|The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm Diameter.|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||percentage of net elasticity||Inter-Quartile Range|Median
2546105|NCT02930590|Secondary|Skin Elastic Function (Ur/Ue) at the Sacrum, 20 Minutes After Off-loading|The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm Diameter.|20 minutes after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||percentage of net elasticity||Inter-Quartile Range|Median
2546106|NCT02930590|Secondary|Skin Elastic Function (Ur/Ue) at the Sacrum, After Two Hours Loading|The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm Diameter.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||percentage of net elasticity||Inter-Quartile Range|Median
2546107|NCT02930590|Secondary|Skin Elastic Function (Ur/Ue) at the Sacrum, at Baseline|The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm Diameter.|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||percentage of net elasticity||Inter-Quartile Range|Median
2546108|NCT02930590|Secondary|Elastic Recovery (Ur/Uf) at the Heel, 20 Minutes After Off-loading|The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm Diameter.|20 minutes after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||proportion of the elastic recovery||Inter-Quartile Range|Median
2546109|NCT02930590|Secondary|Elastic Recovery (Ur/Uf) at the Heel, After Two Hours Loading|The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm Diameter.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||proportion of the elastic recovery||Inter-Quartile Range|Median
2546110|NCT02930590|Secondary|Elastic Recovery (Ur/Uf) at the Heel, at Baseline|The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm Diameter.|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||proportion of the elastic recovery||Inter-Quartile Range|Median
2546111|NCT02930590|Secondary|Elastic Recovery (Ur/Uf) at the Sacrum, 20 Minutes After Off-loading|The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm Diameter.|20 minutes after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||proportion of the elastic recovery||Inter-Quartile Range|Median
2546112|NCT02930590|Secondary|Elastic Recovery (Ur/Uf) at the Sacrum, After Two Hours Loading|The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm Diameter.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||proportion of the elastic recovery||Inter-Quartile Range|Median
2546113|NCT02930590|Secondary|Elastic Recovery (Ur/Uf) at the Sacrum, at Baseline|The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm Diameter.|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||proportion of the elastic recovery||Inter-Quartile Range|Median
2546114|NCT02930590|Secondary|Skin Extensibility (Uf) in mm at the Heel, 20 Minutes After Off-loading|Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm).|20 minutes after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||mm||Inter-Quartile Range|Median
2546115|NCT02930590|Secondary|Skin Extensibility (Uf) in mm at the Heel, After Two Hours Loading|Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm).|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||mm||Inter-Quartile Range|Median
2546116|NCT02930590|Secondary|Skin Extensibility (Uf) in mm at the Heel, at Baseline|Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm).|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||mm||Inter-Quartile Range|Median
2546117|NCT02930590|Secondary|Skin Extensibility (Uf) in mm at the Sacrum, 20 Minutes After Off-loading|Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the Skin in mm (Uf, mm).|20 minutes after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||mm||Inter-Quartile Range|Median
2546118|NCT02930590|Secondary|Skin Extensibility (Uf) in mm at the Sacrum, After Two Hours Loading|Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of −450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm(Uf, mm).|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||mm||Inter-Quartile Range|Median
2546119|NCT02930590|Secondary|Skin Extensibility (Uf) in mm at the Sacrum, at Baseline|Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted with a pressure of −450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm).|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||mm||Inter-Quartile Range|Median
2546120|NCT02930590|Secondary|Skin Surface Maximum Roughness (Rmax) in µm at the Heel, 20 Min After Off-loading|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.|20 minutes after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546121|NCT02930590|Secondary|Skin Surface Maximum Roughness (Rmax) in µm at the Heel, at Baseline|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546122|NCT02930590|Secondary|Skin Surface Maximum Roughness (Rmax) in µm at the Heel, After Two Hours Loading|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546366|NCT02925403|Primary|Safety and Tolerability of Administration of R21/Matrix-M1 Assessed by the Occurrence of Solicited Local and Systemic Adverse Events.|Occurrence of solicited local and systemic adverse events (i.e: pain, redness, swelling and pruritus at injection site and temperature, feverishness, myalgia, arthralgia, malaise, headache and nausea).|Assessment of solicited AEs in the first 7 days post vaccination.||||Number of adverse events|||Number
2546123|NCT02930590|Secondary|Skin Surface Mean Roughness (Ra) in μm at the Heels, 20 Min After Off-loading|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.|20 min after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546124|NCT02930590|Secondary|Skin Surface Mean Roughness (Ra) in μm at the Heels, After Two Hours Loading|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546125|NCT02930590|Secondary|Skin Surface Mean Roughness (Ra) in μm at the Heels, at Baseline|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546126|NCT02930590|Secondary|Skin Surface Mean Roughness (Rz) in μm at the Heels, 20min Off-loading|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.|20 min after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546127|NCT02930590|Secondary|Skin Surface Mean Roughness (Rz) in μm at the Heels, After Two Hours Loading|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546128|NCT02930590|Secondary|Skin Surface Mean Roughness (Rz) in μm at the Heel, at Baseline|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546129|NCT02930590|Secondary|Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, 20 Min Off-loading|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.|20 minutes after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546130|NCT02930590|Secondary|Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, After Two Hours Loading|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546131|NCT02930590|Secondary|Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, at Baseline|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546132|NCT02930590|Secondary|Skin Surface Mean Roughness (Ra) in μm at the Sacrum, 20 Min Off-loading|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.|20 min after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546133|NCT02930590|Secondary|Skin Surface Mean Roughness (Ra) in μm at the Sacrum, After Two Hours Loading|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546134|NCT02930590|Secondary|Skin Surface Mean Roughness (Ra) in μm at the Sacrum, at Baseline|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2550652|NCT02829944|Secondary|Pain Scores at Rest|Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable|24 hours||||score on a scale||Inter-Quartile Range|Mean
2546135|NCT02930590|Secondary|Skin Surface Mean Roughness (Rz) in μm at the Sacrum, 20 Min After Off-loading|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.|20 min after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546136|NCT02930590|Secondary|Skin Surface Mean Roughness (Rz) in μm at the Sacrum, After Two Hours Loading|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546137|NCT02930590|Secondary|Skin Surface Mean Roughness (Rz) in μm at the Sacrum, at Baseline|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||µm||Inter-Quartile Range|Median
2546138|NCT02930590|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, 20min Off-loading|Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer.|20 min after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||arbitrary units||Inter-Quartile Range|Median
2546139|NCT02930590|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, After Two Hours Loading|Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||arbitrary units||Inter-Quartile Range|Median
2546140|NCT02930590|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, at Baseline|Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU).Lower values represent reduced skin hydration in the upper skin layer.|Baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||arbitrary units||Inter-Quartile Range|Median
2546141|NCT02930590|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, 20 Min Off-loading|Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU).Lower values represent reduced skin hydration in the upper skin layer.|20 min after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||arbitrary units||Inter-Quartile Range|Median
2546142|NCT02930590|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, After Two Hours Loading|Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||arbitrary units||Inter-Quartile Range|Median
2546143|NCT02930590|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, at Baseline|Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer.|at baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||arbitrary units||Inter-Quartile Range|Median
2546144|NCT02930590|Secondary|Erythema Index in Arbitrary Units at the Heels, 20 Min After Off-loading|Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.|20 min after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||arbitrary units||Inter-Quartile Range|Median
2546145|NCT02930590|Secondary|Erythema Index in Arbitrary Units at the Heels, After Two Hours Loading|Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||arbitrary units||Inter-Quartile Range|Median
2546146|NCT02930590|Secondary|Erythema Index in Arbitrary Units at the Heels, at Baseline|Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.|at baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||arbitrary units||Inter-Quartile Range|Median
2546147|NCT02930590|Secondary|Erythema Index in Arbitrary Units at the Sacrum, 20 Min After Off-loading|Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.|20 min after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||arbitrary units||Inter-Quartile Range|Median
2546148|NCT02930590|Secondary|Erythema Index in Arbitrary Units at the Sacrum, After Two Hours Loading|Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||arbitrary units||Inter-Quartile Range|Median
2546149|NCT02930590|Secondary|Erythema Index in Arbitrary Units at the Sacrum, at Baseline|Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.|at baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||arbitrary units||Inter-Quartile Range|Median
2546150|NCT02930590|Secondary|Skin Surface Temperature in °C Per Skin Area at the Heel, 20 Minutes After Off-loading|Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.|20 minutes after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||°C||Inter-Quartile Range|Median
2546151|NCT02930590|Secondary|Skin Surface Temperature in °C Per Skin Area at the Heel, After Two Hours Loading|Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||°C||Inter-Quartile Range|Median
2546152|NCT02930590|Secondary|Skin Surface Temperature in °C Per Skin Area at the Heel, at Baseline|Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.|at baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||°C||Inter-Quartile Range|Median
2546153|NCT02930590|Secondary|Skin Surface Temperature in °C Per Skin Area at the Sacrum, 20 Minutes After Off-loading|Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.|20 minutes after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||°C||Inter-Quartile Range|Median
2546154|NCT02930590|Secondary|Skin Surface Temperature in °C Per Skin Area at the Sacrum, After Two Hours|Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.|after two hours|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||°C||Inter-Quartile Range|Median
2546155|NCT02930590|Secondary|Skin Surface Temperature in °C Per Skin Area at the Sacrum, at Baseline|Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.|at baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||°C||Inter-Quartile Range|Median
2546156|NCT02930590|Primary|Transepidermal Water Loss (TEWL) in g/m2/h on Heel, 20 Min After Off-loading|TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).|20 min after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||g/m2/h||Inter-Quartile Range|Median
2546157|NCT02930590|Primary|Transepidermal Water Loss (TEWL) in g/m2/h on Heel, After Two Hours Loading|TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||g/m2/h||Inter-Quartile Range|Median
2546158|NCT02930590|Primary|Transepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baseline|TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).|at baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||g/m2/h||Inter-Quartile Range|Median
2546159|NCT02930590|Primary|Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, 20 Min After Off-loading|TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).|20 min after off-loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||g/m2/h||Inter-Quartile Range|Median
2546160|NCT02930590|Primary|Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, After Two Hours Loading|TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).|after two hours loading|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||g/m2/h||Inter-Quartile Range|Median
2546161|NCT02930590|Primary|Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline|TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).|at baseline|Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.|||g/m2/h||Inter-Quartile Range|Median
2546162|NCT02930226|Secondary|Document if Changes in Specific Chemistry Values Are Within Clinically Meaningful Levels Pre and Post Infusion by Evaluating Laboratory Tests|Determine if the changes in specific chemistry values are similar with clinically meaningful levels pre and post infusion in the different arm groups.|For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43.||||Participants|||Count of Participants
2546163|NCT02930226|Secondary|Document if Changes in Specific Hematology Values Are Within Clinically Meaningful Levels Pre and Post Infusion by Evaluating Laboratory Tests|Determine if the changes in specific hematology values are similar with clinically meaningful levels pre and post infusion in the different arm groups.|For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43.||||Participants|||Count of Participants
2550653|NCT02829944|Secondary|Pain Scores at Rest|Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable|2 hours||||score on a scale||Inter-Quartile Range|Median
2546164|NCT02930226|Secondary|Document if Changes in Specific Coagulation Values Are Within Clinically Meaningful Levels Pre and Post Infusion by Evaluating Laboratory Tests|Determine if the changes in specific coagulation values are similar with clinically meaningful levels pre and post infusion in the different arm groups.|For cohorts 1 and 2, follow-up assessments on days 2, 8 and 29. For cohort 3, follow-up assessments on days 2, 8, 16, 22, and 43.||||Participants|||Count of Participants
2546165|NCT02930226|Secondary|Safety of Fixed-dose Infusions of 3 FDP Units in Comparison to 3 FFP Units in Normal Healthy Subjects by Evaluating Vital Signs and Laboratory Tests|Assess the safety of a fixed-dose infusion of 3 FDP units in comparison to infusion with the same dose of autologous Fresh Frozen Plasma (FFP) collected|Follow-up assessments on days 2, 8, 16, 22, 43, and telephone assessments on days 3, 4, 17, and 18||||Participants|||Count of Participants
2546166|NCT02930226|Primary|Safety of Single Infusions of FDP at Increasing Fixed Doses in Normal Healthy Subjects by Evaluating Vital Signs and Laboratory Tests|Assess the safety of single infusions of FDP at increasing fixed doses of either 1 unit, 2 units, or 3 units in normal healthy subjects by evaluating vital signs during and after infusion|Follow-up assessments on days 2, 8, 29, and telephone assessments on days 3 and 4||||Participants|||Count of Participants
2546167|NCT02930174|Secondary|Regional Change in EELI: Ventral|"EELI is the impedance at the end of tidal variation, or end-expiration. EELI reflects the end-expiratory lung volume (EELV); thus an increase in EELI represents and increase in lung volume.~The change in EELI that the electrical impedance tomography (EIT) device (Pulmovista, Drager) provides is the percent difference between the EELI of a given period and the EELI during a baseline or reference period. Positive or negative percent change suggests an increase or decrease in EELI and presumably EELV by a similar percentage. The baseline measurements used here were taken breathing air and no pressures applied, while the other measurements were taken with varying levels of pressure applied.~By definition, baseline is assigned the value of 0%, by the EIT device. While it would be helpful to have the actual numbers for the baseline impedance values, this data was not provided by the EIT device"|1 day|Because one subject's EELI data did not record properly on device 2, that subject's data was excluded from analysis for both arms.|||percentage change from baseline||Standard Deviation|Mean
2546168|NCT02930174|Secondary|Regional Change in EELI: Dorsal|"EELI is the impedance at the end of tidal variation, or end-expiration. EELI reflects the end-expiratory lung volume (EELV); thus an increase in EELI represents and increase in lung volume.~The change in EELI that the electrical impedance tomography (EIT) device (Pulmovista, Drager) provides is the percent difference between the EELI of a given period and the EELI during a baseline or reference period. Positive or negative percent change suggests an increase or decrease in EELI and presumably EELV by a similar percentage. The baseline measurements used here were taken breathing air and no pressures applied, while the other measurements were taken with varying levels of pressure applied.~By definition, baseline is assigned the value of 0%, by the EIT device. While it would be helpful to have the actual numbers for the baseline impedance values, this data was not provided by the EIT device"|1 day|Because one subject's EELI data did not record properly on device 2, that subject's data was excluded from analysis for both arms.|||percentage change from baseline||Standard Deviation|Mean
2546169|NCT02930174|Secondary|Global Change in End-expiratory Lung Impedance (EELI)|"EELI is the impedance at the end of tidal variation, or end-expiration. EELI reflects the end-expiratory lung volume (EELV); thus an increase in EELI represents and increase in lung volume.~The change in EELI that the electrical impedance tomography (EIT) device (Pulmovista, Drager) provides is the percent difference between the EELI of a given period and the EELI during a baseline or reference period. Positive or negative percent change suggests an increase or decrease in EELI and presumably EELV by a similar percentage. The baseline measurements used here were taken breathing air and no pressures applied, while the other measurements were taken with varying levels of pressure applied.~By definition, baseline is assigned the value of 0%, by the EIT device. While it would be helpful to have the actual numbers for the baseline impedance values, this data was not provided by the EIT device."|1 day|Because one subject's EELI data did not record properly on device 2, that subject's data was excluded from analysis for both arms.|||percentage change from baseline||Standard Deviation|Mean
2546170|NCT02930174|Secondary|Regional Tidal Variation: Ventral|Distribution of ventilation for a breath averaged over a defined section, the ventral lung regions. Reflects the percent of tidal volume distributed to that area.|1 day||||percentage of global TID||Standard Deviation|Mean
2546171|NCT02930174|Secondary|Regional Tidal Variation: Dorsal|Distribution of ventilation for a breath averaged over a defined section, the dorsal lung regions. Reflects the percent of tidal volume distributed to that area.|1 day||||percentage of global TID||Standard Deviation|Mean
2546172|NCT02930174|Primary|Global Tidal Variation (TID)|TID is the distribution of ventilation for a breath averaged over a defined section, the entire lung. TID is analogous to the tidal volume. Baseline is defined to be 100% and other measures are in comparison to baseline (eg, a value of 102 represents a 2% increase from baseline).|1 day||||percentage of baseline||Standard Deviation|Mean
2546173|NCT02930005|Secondary|Change in Severity of Psychotic Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS)|Change in the Positive and Negative Syndrome Scale (PANSS) total score after 8 weeks. The range of scores on the PANSS is 30 to 210, with higher scores associated with better outcomes.|baseline, 8 weeks||||score|||Number
2546174|NCT02930005|Primary|Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery (NCTB) Composite Score|"A higher composite score on the NCTB indicates better cognitive performance. The NCTB consists of 7 tests and 8 sub-scores, and the NIH Toolbox software calculates total composite score by averaging the normalized scores of each subscale and then deriving scale scores. The NIH Toolbox Scoring and Interpretation Guide (found online) doesn't indicate a total composite score range (because the score ranges are infinite), but describes scoring as follows: To get a normalized composite score, the score of the test taker is compared to the scores in the NIH Toolbox nationally representative normative sample. The mean score is 100 and the standard deviation (SD) is 15. A score at or near 100 indicates average ability compared with others. Scores around 115 suggest above-average ability. Scores around 130 suggest superior ability (in the top 2 percent nationally). A score around 85 suggests below-average ability. A score in the range of 70 or below suggests significant impairment."|baseline, 8 weeks||||score|||Number
2550654|NCT02829944|Primary|Pain Score on Movement (Sitting in Bed From a Supine Position)|Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable|24 hours after surgery||||score on a scale||Inter-Quartile Range|Median
2546175|NCT02929823|Primary|Clearing of Corneal Fluorescein Staining at Week 5|A patient will be considered a success for clearing of corneal fluorescein staining if their fluorescein staining has disappeared|5 weeks|Full Analysis Set: All patients randomly assigned to receive double-masked study drug, who received at least 1 dose of study drug in the study eye, and who had at least 1 post-baseline assessment for the primary efficacy endpoint.|||Participants|||Count of Participants
2546176|NCT02929498|Primary|Part 1: Change From Baseline in Total Bilirubin, Direct Bilirubin, Creatinine and Urate at Indicated Time Points|Blood samples were collected from participants for evaluation of clinical chemistry parameters including Total Bilirubin, Direct Bilirubin, Creatinine and urate. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Micromoles per liter (umol/L)||Standard Deviation|Mean
2546177|NCT02929498|Secondary|Part 2: Number of Participants With Documented Platelet and Red Blood Cell (RBC) Transfusions Per Month|Number of participants with documented platelet and RBC transfusions were to be presented.|Up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546178|NCT02929498|Secondary|Part 2: Time to AML Progression|Time to AML progression is defined as the time from first treatment dose until AML progression or crossover if using the All Treated Subjects Population. For the analysis of time to AML, if the participant did not experience AML, time to AML was to be censored at the last treatment prior to the initiation of anti-cancer therapy or crossover.|Up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546179|NCT02929498|Secondary|Part 2: Percentage of Participants With Disease Progression to AML|The percentage of participants experiencing AML on the All Treated Subjects Population was to be presented.|Up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546180|NCT02929498|Secondary|Part 2: Overall Survival|Overall survival is defined as the time from first treatment dose until death due to any reason. For the analysis of overall survival, the last date of known contact was to be used for those participants who had not died at the time of analysis; such participants were to be considered censored.|Up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546181|NCT02929498|Secondary|Part 2: Progression-free Survival|Progression-free survival is defined as the time from first treatment dose until the first documented sign of disease progression or death. If the participant missed more than one visit prior to the date of documented events, PFS was to be censored at the last adequate assessment prior to missing. Otherwise, if the participant did not have a documented date of events, PFS was to be censored at the date of the last adequate assessment.|Up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546182|NCT02929498|Secondary|Part 2: Duration of Response|Duration of response is defined as the time from first documented evidence of response until the first documented sign of disease progression or death. If no disease progression or death, the duration of response was to be censored at last disease assessment.|Up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546183|NCT02929498|Secondary|Part 2: Plasma Clearance (CL/F) of GSK2879552|Blood samples were to be collected at indicated time points to evaluate CL/F of GSK2879552. Each PK sample was to be collected as close as possible to the planned time relative to the dose (i.e., time zero) administered to the participant on PK days.|Cycle 1, Day 1: pre-dose, 0.5, 1, 3 hour; pre-dose on Day 4; Day 7: pre-dose, 0.5, 1, 3 hour; Day 15: pre-dose, 0.5-1 hour post-dose; pre-dose on Day 22; Cycle 2: pre-dose on Days 1, 7, 15, 22; Pre-dose on Day 1 of Cycles 3 to 1 (each cycle of 28 days)|PK Concentration Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546184|NCT02929498|Secondary|Part 2: Number of Participants With Abnormal Findings During Physical Examination|A complete physical examination included, at a minimum, assessment of the Cardiovascular, Respiratory, Gastrointestinal and Neurological systems. A brief physical examination included, at a minimum assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen).|Up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546185|NCT02929498|Secondary|Part 2: Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time-points|Single 12-lead ECG was to be obtained at designated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.|Baseline and up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546186|NCT02929498|Secondary|Part 2: Change From Baseline in ECG Mean Heart Rate at Indicated Time-points|Single 12-lead ECG was to be obtained at designated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.|Baseline and up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546187|NCT02929498|Secondary|Part 2: Change From Baseline in Body Temperature at Indicated Time-points|Vital signs including body temperature was to be measured after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.|Baseline and up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546188|NCT02929498|Secondary|Part 2: Change From Baseline in Respiratory Rate at Indicated Time-points|Vital signs including respiratory rate was to be measured after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.|Baseline and up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546189|NCT02929498|Secondary|Part 2: Change From Baseline in Heart Rate at Indicated Time-points|Vital signs including heart rate was to be measured after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.|Baseline and up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546190|NCT02929498|Secondary|Part 2: Change From Baseline in SBP and DBP at Indicated Time-points|Vital signs including SBP and DBP were to be measured after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.|Baseline and up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546191|NCT02929498|Secondary|Part 2: Change From Baseline in pCO2 at Indicated Time Points|Blood samples were to be collected from participants for evaluation of clinical chemistry parameters including pCO2. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.|Baseline and up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546192|NCT02929498|Secondary|Part 2: Change From Baseline in Albumin and Protein at Indicated Time Points|Blood samples were to be collected from participants for evaluation of clinical chemistry parameters including Albumin and Protein. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.|Baseline and up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546193|NCT02929498|Secondary|Part 2: Change From Baseline in Total Bilirubin, Direct Bilirubin, Creatinine and Urate at Indicated Time Points|Blood samples were to be collected from participants for evaluation of clinical chemistry parameters including Total Bilirubin, Direct Bilirubin, Creatinine and urate. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.|Baseline and up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546194|NCT02929498|Secondary|Part 2: Change From Baseline in Calcium, Chloride, Glucose, Potassium, Sodium, Phosphate and Urea Nitrogen at Indicated Time-points|Blood samples were to be collected from participants for evaluation of clinical chemistry parameters including Calcium, chloride, glucose, potassium, sodium, phosphate and urea nitrogen. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.|Baseline and up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546195|NCT02929498|Secondary|Part 2: Change From Baseline in ALT, ALP, AST, LDH and GGT at Indicated Time-points|Blood samples were to be collected from participants for evaluation of clinical chemistry parameters including ALT, ALP, AST, LDH and GGT. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.|Baseline and up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546196|NCT02929498|Secondary|Part 2: Change From Baseline in Blast/Leukocytes at Indicated Time-points|Blood samples were to be collected from participants for evaluation of hematology parameters including blast/leukocytes. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.|Baseline and up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546197|NCT02929498|Secondary|Part 2: Change From Baseline in Percent Reticulocytes at Indicated Time-points|Blood samples were to be collected from participants for evaluation of hematology parameters including percent reticulocytes. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.|Baseline and up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546198|NCT02929498|Secondary|Part 2: Change From Baseline in Erythrocytes at Indicated Time-points|Blood samples were to be collected from participants for evaluation of hematology parameters including erythrocytes. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.|Baseline and up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546199|NCT02929498|Secondary|Part 2: Change From Baseline in Hematocrit at Indicated Time-points|Blood samples were to be collected from participants for evaluation of hematology parameters including Hematocrit. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.|Baseline and up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546322|NCT02927327|Secondary|"Number of Participants Reporting Yes On All Binary Performance Scale Questions"|"The number of participants reporting yes on a binary performance scale (Y/N) were collected."|through study completion, an average of 2 months|Functionality ratings, based on a binary performance scale (Y/N), were collected from the population of subjects who completed the study, including both ZTE and Q.Static populations (N=61 total subjects).|||Participants|||Count of Participants
2546200|NCT02929498|Secondary|Part 2: Change From Baseline in MCHC and Hb at Indicated Time-points|Blood samples were to be collected from participants for evaluation of hematology parameters including MCHC and Hb. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.|Baseline and up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546201|NCT02929498|Secondary|Part 2: Change From Baseline in MCH at Indicated Time-points|Blood samples were to be collected from participants for evaluation of hematology parameters including MCH. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.|Baseline and up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546202|NCT02929498|Secondary|Part 2: Change From Baseline in MCV at Indicated Time-points|Blood samples were to be collected from participants for evaluation of hematology parameters including MCV. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.|Baseline and up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546203|NCT02929498|Secondary|Part 2: Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points|Blood samples were to be collected from participants for evaluation of hematology parameters including platelets, neutrophils, monocytes, lymphocytes, leucocyte, eosinophils and basophils. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.|Baseline and up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546204|NCT02929498|Secondary|Part 2: Number of Participants With Any AEs and SAEs|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE.|Up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546205|NCT02929498|Secondary|Part 1: Number of Participants With Documented Platelet and Red Blood Cell (RBC) Transfusions Per Month|Number of participants with documented platelet and RBC transfusions have been presented.|Up to 2 years|All Treated Subjects Population|||Participants|||Count of Participants
2546206|NCT02929498|Secondary|Part 1: Time to AML Progression|Time to AML progression is defined as the time from first treatment dose until AML progression or crossover if using the All Treated Subjects Population. For the analysis of time to AML, if the participant did not experience AML, time to AML was censored at the last treatment prior to the initiation of anti-cancer therapy or crossover.|Up to 2 years|All Treated Subjects Population|||Weeks||95% Confidence Interval|Median
2546207|NCT02929498|Secondary|Part 1: Proportion of Participants With Disease Progression to Acute Myeloblastic Leukemia (AML)|The proportion of participants with disease progression to AML is defined as the percentage of participants experiencing AML on the All Treated Subjects Population.|Up to 2 years|All Treated Subjects Population|||Percentage of Participants|||Number
2546208|NCT02929498|Secondary|Part 1: Overall Survival|Overall survival (OS) is defined as the time from first treatment dose until death due to any reason. For the analysis of overall survival (OS), the last date of known contact was used for those participants who had not died at the time of analysis; such participants were considered censored.|Up to 2 years|All Treated Subjects Population|||Weeks||95% Confidence Interval|Median
2546209|NCT02929498|Secondary|Part 1: Progression-free Survival|Progression-free survival (PFS) is defined as the time from first treatment dose until the first documented sign of disease progression or death. If the participant missed more than one visit prior to the date of documented events, PFS was censored at the last adequate assessment prior to missing. Otherwise, if the participant did not have a documented date of events, PFS was censored at the date of the last adequate assessment.|Up to 2 years|All Treated Subjects Population|||Weeks||95% Confidence Interval|Median
2546210|NCT02929498|Secondary|Part 1: Duration of Response|Duration of response is defined as the subset of participants (responders) who show a response (CR, mCR, PR, or HI), the time from first documented evidence of response until the first documented sign of disease progression or death. If no disease progression or death, the DOR was to be censored at last disease assessment.|Up to 2 years|All Treated Subjects Population. Data was not collected for this endpoint as DOR could not be calculated because of the early termination of the study did not allow for this endpoint to be observed.||||||
2546211|NCT02929498|Secondary|Part 1: Plasma Concentration of Azacitidine|Blood samples were to be collected at indicated time points to evaluate concentration of Azacitidine.|Cycle 1, Day 1: pre-dose, 0.5, 1, 3 hour; pre-dose on Days 2,4; Day 7: pre-dose, 0.5, 1, 3 hour; Day 15: pre-dose, 0.5-1 hour post-dose; pre-dose on Day 22; Cycle 2: pre-dose on Days 1, 7, 15, 22; Pre-dose on Day 1 of Cycles 3,4,5 (each cycle of 28 days)|PK Concentration Population. Data was not collected due to blood samples were not collected as participants were not enrolled in GSK2879552 + Azacitidine arm due to early termination of the study.||||||
2546222|NCT02929498|Primary|Part 1: Change From Baseline in Heart Rate at Indicated Time-points|Vital signs including heart rate was measured after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline and Cycle 1 (Days 7, 15), Cycle 2 (Day 1), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Beats per minute||Standard Deviation|Mean
2546212|NCT02929498|Secondary|Part 1: Plasma Concentration of GSK2879552|Blood samples were collected at indicated time points to evaluate concentration of GSK2879552. Each Pharmacokinetic (PK) sample was collected as close as possible to the planned time relative to the dose (i.e., time zero) administered to the participant on PK days. PK Concentration Population consisted of all participants in the All Treated Subject Population for whom a blood sample for pharmacokinetics was obtained and analyzed.|Cycle 1, Day 1: pre-dose, 0.5, 1, 3 hour; pre-dose on Days 2,4; Day 7: pre-dose, 0.5, 1, 3 hour; Day 15: pre-dose, 0.5-1 hour post-dose; pre-dose on Day 22; Cycle 2: pre-dose on Days 1, 7, 15, 22; Pre-dose on Day 1 of Cycles 3,4,5 (each cycle of 28 days)|PK Concentration Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Nanograms per milliliter||Standard Deviation|Mean
2546213|NCT02929498|Secondary|Part 1: Percentage of Participants With Investigator-assessed Best Response Assessed by Objective Response Rate (ORR)|Objective Response Rate was defined as the percentage of participants who achieved Complete Remission (CR) or Partial Remission (PR) or Marrow Complete Remission (mCR) or confirmed Hematologic Improvement (HI) prior to new anti-cancer therapy on the All Treated Subjects Population. Participants with Not Evaluable or missing response were treated as non-responders. International Working Group (IWG) criteria, 2006 was used to evaluate response.|Up to 2 years|All Treated Subjects Population|||Percentage of Participants||95% Confidence Interval|Number
2546214|NCT02929498|Secondary|Part 1: Percentage of Participants With Investigator-assessed Best Response Assessed by Clinical Benefit Rate (CBR)|Clinical Benefit Rate was defined as the percentage of participants achieving a confirmed Complete Remission (CR) or Partial Remission (PR) or Marrow Complete Remission (mCR) or confirmed Hematologic Improvement (HI) or Stable Disease (SD) prior to new anti-cancer therapy and crossover on the All Treated Subjects Population. Participants with Not Evaluable or missing response were treated as non-responders. International Working Group (IWG) criteria, 2006 was used to evaluate response.|Up to 2 years|All Treated Subjects Population|||Percentage of Participants||95% Confidence Interval|Number
2546215|NCT02929498|Primary|Part 2: Percentage of Participants With Investigator-assessed Best Response Assessed by Objective Response Rate (ORR)|Objective response rate was defined as the percentage of participants who achieved CR or PR or mCR or HI prior to new anti-cancer therapy on the All Treated Subjects Population. Participants with Not Evaluable or missing response were to be treated as non-responders. IWG criteria, 2006 was to be used to evaluate response.|Up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546216|NCT02929498|Primary|Part 2: Percentage of Participants With Investigator-assessed Best Response Assessed by Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants achieving a confirmed Complete Remission (CR) or Partial Remission (PR) or Marrow Complete Remission (mCR) or confirmed Hematologic Improvement (HI) or Stable Disease (SD) prior to new anti-cancer therapy and crossover on the All Treated Subjects Population. Participants with Not Evaluable or missing response were to be treated as non-responders. International Working Group (IWG) criteria, 2006 was to be used to evaluate response.|Up to 2.5 years|All Treated Subjects Population. Data was not collected for this endpoint as study was terminated during Part 1 and Part 2 was not initiated.||||||
2546217|NCT02929498|Primary|Part 1: Number of Participants With Abnormal Findings During Physical Examination|A complete physical examination included, at a minimum, assessment of the Cardiovascular, Respiratory, Gastrointestinal and Neurological systems. A brief physical examination included, at a minimum assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). This analysis was planned but data was not captured in the database. Abnormal changes were captured as adverse events if they were clinically significant.|Up to 2 years|All Treated Subjects Population. This analysis was planned but data was not captured in the database.||||||
2546218|NCT02929498|Primary|Part 1: Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTc Corrected by Bazett's Formula (QTcB) and QTc Corrected by Fridericia's Formula (QTcF) at Indicated Time-points|Single 12-lead ECG was obtained at designated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline and Cycle 1 (Days 1,7), Cycle 2 (Day 1), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Milliseconds||Standard Deviation|Mean
2546219|NCT02929498|Primary|Part 1: Change From Baseline in Electrocardiogram (ECG) Mean Heart Rate at Indicated Time-points|Single 12-lead ECG was obtained at designated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline and Cycle 1 (Days 1, 7), Cycle 2 (Day 1), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Beats per minute||Standard Deviation|Mean
2546220|NCT02929498|Primary|Part 1: Change From Baseline in Body Temperature at Indicated Time-points|Vital signs including body temperature was measured after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline and Cycle 1 (Days 7, 15), Cycle 2 (Day 1), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Celsius||Standard Deviation|Mean
2546221|NCT02929498|Primary|Part 1: Change From Baseline in Respiratory Rate at Indicated Time-points|Vital signs including respiratory rate was measured after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline and Cycle 1 (Days 7, 15), Cycle 2 (Day 1), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Breaths per minute||Standard Deviation|Mean
2546223|NCT02929498|Primary|Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points|Vital signs including SBP and DBP were measured after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline and Cycle 1 (Days 7, 15), Cycle 2 (Day 1), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimeters of mercury||Standard Deviation|Mean
2546224|NCT02929498|Primary|Part 1: Change From Baseline in Partial Pressure Carbon Dioxide (pCO2) at Indicated Time Points|Blood samples were collected from participants for evaluation of clinical chemistry parameters including pCO2. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline and Day 1 of Cycle 1 (cycle of 28 days)|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed.|||Kilopascal||Standard Deviation|Mean
2546225|NCT02929498|Primary|Part 1: Change From Baseline in Albumin and Protein at Indicated Time Points|Blood samples were collected from participants for evaluation of clinical chemistry parameters including Albumin and Protein. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||G/L||Standard Deviation|Mean
2546226|NCT02929498|Primary|Part 1: Change From Baseline in Calcium, Chloride, Glucose, Potassium, Sodium, Phosphate and Urea Nitrogen at Indicated Time-points|Blood samples were collected from participants for evaluation of clinical chemistry parameters including calcium, chloride, glucose, potassium, sodium, phosphate and urea nitrogen. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2546227|NCT02929498|Primary|Part 1: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) and Gamma Glutamyl Transferase (GGT) at Indicated Time-points|Blood samples were collected from participants for evaluation of clinical chemistry parameters including ALT, ALP, AST, LDH and GGT. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||International unit per liter (IU/L)||Standard Deviation|Mean
2546228|NCT02929498|Primary|Part 1: Change From Baseline in Blast/Leukocytes at Indicated Time-points|Blood samples were collected from participants for evaluation of hematology parameters including blast/leukocytes. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline and Day 1 of Cycle 1 (Cycle of 28 days)|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed.|||Ratio of blasts to leukocytes||Standard Deviation|Mean
2546229|NCT02929498|Primary|Part 1: Change From Baseline in Percent Reticulocytes at Indicated Time-points|Blood samples were collected from participants for evaluation of hematology parameters including percent reticulocytes. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1) (each cycle of 28 days)|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed.|||Percentage of reticulocytes||Standard Deviation|Mean
2546230|NCT02929498|Primary|Part 1: Change From Baseline in Erythrocytes at Indicated Time-points|Blood samples were collected from participants for evaluation of hematology parameters including erythrocytes. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||10^12 cells per Liter||Standard Deviation|Mean
2546231|NCT02929498|Primary|Part 1: Change From Baseline in Hematocrit at Indicated Time-points|Blood samples were collected from participants for evaluation of hematology parameters including Hematocrit. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Proportion of red blood cells in blood||Standard Deviation|Mean
2546232|NCT02929498|Primary|Part 1: Change From Baseline in Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points|Blood samples were collected from participants for evaluation of hematology parameters including MCHC and Hb. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2560355|NCT02664272|Secondary|Number of Hips With Intraoperative Complications|Intraoperative complications were collected as a secondary outcome.|Intraoperative examination only||||hips|hips||Count of Units
2546233|NCT02929498|Primary|Part 1: Change From Baseline in Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points|Blood samples were collected from participants for evaluation of hematology parameters including MCH. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Picogram||Standard Deviation|Mean
2546234|NCT02929498|Primary|Part 1: Change From Baseline in Mean Corpuscular Volume (MCV) at Indicated Time-points|Blood samples were collected from participants for evaluation of hematology parameters including MCV. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Femtoliter||Standard Deviation|Mean
2546235|NCT02929498|Primary|Part 1: Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points|Blood samples were collected from participants for evaluation of hematology parameters including platelets, neutrophils, monocytes, lymphocytes, leucocyte, eosinophils and basophils. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||10^9 cells per liter||Standard Deviation|Mean
2546236|NCT02929498|Primary|Part 1: Number of Participants With Any Non-serious Adverse Event (Non-SAE), Serious AE (SAE), Dose Limiting Toxicities (DLT), Dose Reductions or Delays and Withdrawals Due to Toxicities|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. An event was considered a DLT if it occurred within the first 28 days of treatment, and met the DLT criteria unless it could be clearly established that the event was unrelated to treatment.|Up to 2 years|All Treated Subjects Population: All participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2546237|NCT02929407|Primary|Change in Blood Gas (PaCO2)|The trial was terminated early due to low recruitment. Only four subjects (all received different dosing regimens) were enrolled into open-label, exploratory Part 1 of the trial, prior to the early termination. No subjects were enrolled in the randomized, double-blind, placebo-controlled Part 2 of the trial. Thus no meaningful statistical analysis could be conducted.|From baseline (pre-dose) to 3 hours after start of infusion|There were too few subjects for statistical analysis (see measure description).||||||
2546238|NCT02929407|Primary|Change in Blood Gas (PaO2)|The trial was terminated early due to low recruitment. Only four subjects were enrolled (all received different dosing regimens) into open-label, exploratory Part 1 of the trial, prior to the early termination. No subjects were enrolled in the randomized, double-blind, placebo-controlled Part 2 of the trial. Thus no meaningful statistical analysis could be conducted.|From baseline (pre-dose) to 3 hours after start of infusion|There were too few subjects for statistical analysis (see measure description).||||||
2546239|NCT02929407|Primary|Change in Electrocardiogram (ECG) Parameters|The trial was terminated early due to low recruitment. Only four subjects were enrolled (all received different dosing regimens) into open-label, exploratory Part 1 of the trial, prior to the early termination. No subjects were enrolled in the randomized, double-blind, placebo-controlled Part 2 of the trial. Thus no meaningful statistical analysis could be conducted.|From baseline (pre-dose) up to Day 14|There were too few subjects for statistical analysis (see measure description).||||||
2546240|NCT02929407|Primary|Pharmacokinetics: Volume of Distribution Associated With the Terminal Phase (Vz)|The trial was terminated early due to low recruitment. Only four subjects were enrolled (all received different dosing regimens) into open-label, exploratory Part 1 of the trial, prior to the early termination. No subjects were enrolled in the randomized, double-blind, placebo-controlled Part 2 of the trial. Thus no meaningful statistical analysis could be conducted.|Pre-dose, 0.5, 1, 2, 3, and 4 hours after start of infusion|There were too few subjects for statistical analysis (see measure description).||||||
2546241|NCT02929407|Primary|Pharmacokinetics: Elimination Half-life (t1/2)|The trial was terminated early due to low recruitment. Only four subjects were enrolled (all received different dosing regimens) into open-label, exploratory Part 1 of the trial, prior to the early termination. No subjects were enrolled in the randomized, double-blind, placebo-controlled Part 2 of the trial. Thus no meaningful statistical analysis could be conducted.|Pre-dose, 0.5, 1, 2, 3, and 4 hours after start of infusion|There were too few subjects for statistical analysis (see measure description).||||||
2546242|NCT02929407|Primary|Pharmacokinetics: Total Systemic Clearance (CL)|The trial was terminated early due to low recruitment. Only four subjects (all received different dosing regimens) were enrolled into open-label, exploratory Part 1 of the trial, prior to the early termination. No subjects were enrolled in the randomized, double-blind, placebo-controlled Part 2 of the trial. Thus no meaningful statistical analysis could be conducted.|Pre-dose, 0.5, 1, 2, 3, and 4 hours after start of infusion|There were too few subjects for statistical analysis (see measure description).||||||
2546261|NCT02928029|Primary|Phase 1: MTD/RP2D Determined by the Incidence of DLTs|Maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) determined by incidence of dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 for the severity grade|From the start of study medication through 3 weeks after administration of the second dose of radium-223 dichloride, assessed up to 9 weeks|The safety analysis set including all participants who received at least one administration of study treatment|||KBq/kg|||Number
2546243|NCT02929407|Primary|Pharmacokinetics: Area Under the Concentration-time Curve to Infinity (AUC)|The trial was terminated early due to low recruitment. Only four subjects were enrolled (all received different dosing regimens) into open-label, exploratory Part 1 of the trial, prior to the early termination. No subjects were enrolled in the randomized, double-blind, placebo-controlled Part 2 of the trial. Thus no meaningful statistical analysis could be conducted.|Pre-dose, 0.5, 1, 2, 3, and 4 hours after start of infusion|There were too few subjects for statistical analysis (see measure description).||||||
2546244|NCT02929407|Primary|Pharmacokinetics: Maximum Concentration Observed (Cmax)|The trial was terminated early due to low recruitment. Only four subjects (all received different dosing regimens) were enrolled into open-label, exploratory Part 1 of the trial, prior to the early termination. No subjets were enrolled in the randomized, double-blind, placebo-controlled Part 2 of the trial. Thus no meaningful statistical analysis could be conducted.|Pre-dose, 0.5, 1, 2, 3, and 4 hours after start of infusion|There were too few subjects for statistical analysis (see measure description).||||||
2546245|NCT02929407|Primary|Change in Plasma Lactate Levels|The trial was terminated early due to low recruitment. Only four subjects (all received different dosing regimens) were enrolled into open-label, exploratory Part 1 of the trial, prior to the early termination. No subjects were enrolled in the randomized, double-blind, placebo-controlled Part 2 of the trial. Thus no meaningful statistical analysis could be conducted.|From baseline (pre-dose) to 3 hours after start of infusion|There were too few subjects for statistical analysis (see measure description).||||||
2546246|NCT02929407|Primary|Change in Systolic and Diastolic Blood Pressure|The trial was terminated early due to low recruitment. Only four subjects (all received different dosing regimens) were enrolled into open-label, exploratory Part 1 of the trial, prior to the early termination. No subjects were enrolled in the randomized, double-blind, placebo-controlled Part 2 of the trial. Thus no meaningful statistical analysis could be conducted.|From baseline (pre-dose) up to Day 14|There were too few subjects for statistical analysis (see measure description).||||||
2546247|NCT02929407|Primary|Type, Frequency and Intensity of Adverse Events (AEs)|"The trial was terminated early due to low recruitment. Only four subjects (all received different dosing regimens) were enrolled into open-label, exploratory Part 1 of the trial, prior to the early termination. No subjects were enrolled in the randomized, double-blind, placebo-controlled Part 2 of the trial. Thus no meaningful statistical analysis could be conducted.~Due to the low number of subjects and individual dosing regimens, AEs were pooled for all dose levels."|Up to Day 14|There were too few subjects for statistical analysis (see measure description).|||Participants|||Count of Participants
2546248|NCT02929407|Primary|Change in Hepatic Venous Pressure Gradient (HVPG)|The trial was terminated early due to low recruitment. Only four subjects were enrolled into the open-label, exploratory Part 1 of the trial, and only three of these four subjects (all receiving different dosing regimens) completed the trial and the HVPG assessments prior to the early termination decision. No subjects were enrolled into the randomized, double-blind, placebo-controlled Part 2 of the trial. As only Part 2 of the trial would have been appropriately powered, and the three subjects with HVPG assessments from Part 1 all received different dosing regimens, no meaningful statistical analysis could be conducted.|From baseline (pre-dose) to 2 hours after start of infusion|There were too few subjects for statistical analysis (see measure description).||||||
2546249|NCT02928770|Primary|Apnea-Hypopnea Index (AHI)|Abnormal breathing events (apneas = complete pauses in oronasal airflow; hypopneas = decreases in oronasal airflow) per hour of sleep. This is measured through polysomnography (sleep study) by a nasal thermistor and oral pressure sensor.|In-lab sleep study obtained at least 7 nights following use of the device at home||||events/hour||Standard Deviation|Mean
2546250|NCT02928536|Secondary|Prevalence of Never, Current and Former Electronic Cigarette Users|Electronic cigarette use is assessed at baseline (thus representing current use at interview) through self-reported questions on lifetime use. Current electronic cigarette users were defined as those who reported using the electronic cigarette occasionally (5 days or less) or regularly (more than 5 days) in the last 30 days. Former users of electronic cigarette were those who reported using it in the part but not over the last 30 days.|Baseline|Participants with available information on electronic cigarette use|||Participants|||Count of Participants
2546251|NCT02928536|Secondary|Prevalence of Never, Current and Former Smokers|Cigarette consumption is assessed at baseline (thus representing current use at interview) through self-reported questions on lifetime use. Never smokers were defined as participants who had never smoked or had smoked less than 100 cigarettes in their lifetime. Smokers were defined as participants who reported smoking at least 100 cigarettes (including hand-rolled cigarettes) during their lifetime. Current smokers were smokers who reported smoking at the time they participated in this survey, while former smokers were smokers who stopped smoking by the time they participated in this survey.|Baseline||||Participants|||Count of Participants
2546252|NCT02928536|Primary|Prevalence of Exposure to Secondhand Aerosol (SHA) From Electronic Cigarettes|Exposure to secondhand aerosol (SHA) is assessed among electronic cigarette non-users and indicates the general daily exposure (during a working day and during a non-working day) to SHA in indoor settings (i.e., at home, at workplace, in public and private transports and in other indoor settings). SHA exposure is self-reported and is assessed through a face-to-face interview at baseline (thus representing current exposure at interview).|Baseline|Electronic cigarette non-users (i.e., never or former users) aged 15 years or more from 12 European countries|||Participants|||Count of Participants
2546253|NCT02928536|Primary|Prevalence of Daily Exposure to Secondhand Smoke (SHS) in Indoor Settings|Exposure to secondhand smoke (SHS) is assessed among non-smokers and indicates the general daily exposure (during a working day and during a non-working day) to SHS in indoor settings (i.e., at home, at workplace, in public and private transports and in other indoor settings). SHS exposure is self-reported and is assessed through a face-to-face interview at baseline (thus representing current exposure at interview).|Baseline|Non-smokers (i.e., never and former smokers) aged 15 years or more from 12 European countries|||Participants|||Count of Participants
2546323|NCT02927327|Secondary|Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score|Ease of use ratings, based on a 5-point Likert scale (e.g. 1=unacceptable, 2=poor, 3=acceptable, 4=good, 5=excellent), were collected from the population of subjects who completed the study.|through study completion, an average of 2 months||||scores on a scale||Standard Deviation|Mean
2560533|NCT02663232|Secondary|Percentage of Participants With Family History of Melanoma||Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
2546254|NCT02928380|Secondary|Kapur (Olshan Modification) Index Scores for Denture Stability|Kapur (Olshan modification) Index scores were assessed to examine each denture (upper & lower) for its stability ability. Stability was measured using score of 0-4: 4= Excellent- when denture base offered no rocking on its supporting structures under pressure; 3= Good- when denture base had very slight rocking on its supporting structures under pressure; 2= Fair- when denture base had slight rocking on its supporting structures under pressure; 1= Poor- when denture base had moderate rocking on its supporting structures under pressure; 0= No stability- when denture base had extreme rocking under pressure. Higher the score, higher the stability ability of denture.|Up to 17 days|Analysis for this outcome was performed on ITT population including all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2546255|NCT02928380|Secondary|Kapur (Olshan Modification) Index Scores for Denture Retention|Kapur (Olshan modification) Index scores were assessed to examine each denture (upper & lower) for its retention ability. Retention was measured as score of 0-5 to assess nature of resistance offered by denture to vertical pull & lateral force: 5=Excellent - denture offered excellent resistance to vertical pull and lateral force; 4= Very Good- denture offered very good resistance to vertical pull and lateral force; 3= Good- denture offered moderate resistance to vertical pull and lateral force; 2= Fair- denture offered moderate resistance to vertical pull and little or no resistance to lateral forces; 1= Poor- denture offers slight resistance to vertical pull and little or no resistance to lateral force; 0= No retention- when the denture was seated in place, it displaced itself. Higher the score, higher the retention ability of denture.|Up to 17 days|Analysis for this outcome was performed on ITT population including all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2546256|NCT02928380|Secondary|Composite Kapur (Olshan Modification) Index Scores for Denture Retention and Stability|Kapur (Olshan modification) Index score was assessed to examine each denture (upper & lower) for retention & stability. Retention was measured as score of 0-5 to assess nature of resistance offered by denture to vertical pull & lateral force: 5=Excellent;4=Very Good;3=Good;2=Fair;1= Poor;0=No retention. Stability was measured as score of 0-4 to assess nature of rocking offered by denture base on its supporting structures under pressure:4=Excellent (no rocking);3=Good (very slight rocking);2=Fair (slight rocking);1=Poor (moderate rocking);0=No stability (extreme rocking). Composite Kapur (Olshan modification) Index scores was measured as the sum score of retention & stability for upper or lower dentures separately such that a sum score of zero represents no retention and stability and a sum score of 9 represents excellent retention and stability.|Up to 17 days|Analysis for this outcome was performed on ITT population including all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2546257|NCT02928380|Secondary|Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and Reference Denture Adhesive|Participants were provided with 30-32 g (accurately weighed) non-salted peanuts, divided into smaller portions of approximately four whole peanuts. Each portion chewed for approximately 20 seconds. After completion of the peanut consumption, participants rinsed their mouth with water, participants may remove any residual peanut particles from their mouth with water and a gauze pad. Participants than removed their dentures. Peanut particles were collected from the fit surfaces of the dentures and the gauzes, and weighed to evaluate the mass of food particles that had migrated under the denture (keeping the particles associated with the upper and lower dentures separate).|up to 17 days|Analysis for this outcome was performed on ITT population including all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment.|||g||Standard Deviation|Mean
2546258|NCT02928380|Secondary|Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for an Experimental Denture Adhesive and on no Adhesive Use|Participants were provided with 30-32 g (accurately weighed) non-salted peanuts, divided into smaller portions of approximately four whole peanuts. Each portion chewed for approximately 20 seconds. After completion of the peanut consumption, participants rinsed their mouth with water, participants may remove any residual peanut particles from their mouth with water and a gauze pad. Participants than removed their dentures. Peanut particles were collected from the fit surfaces of the dentures and the gauzes, and weighed to evaluate the mass of food particles that had migrated under the denture (keeping the particles associated with the upper and lower dentures separate).|Up to 17 days|Analysis for this outcome was performed on ITT population including all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment.|||g||Standard Deviation|Mean
2546259|NCT02928380|Primary|Combined Mass of Peanuts (Gram) (From Upper and Lower Dentures) for Reference Denture Adhesive and on no Adhesive Use|Participants were provided with 30-32 g (accurately weighed) non-salted peanuts, divided into smaller portions of approximately four whole peanuts. Each portion chewed for approximately 20 seconds. After completion of the peanut consumption, participants rinsed their mouth with water, participants may remove any residual peanut particles from their mouth with water and a gauze pad. Participants than removed their dentures. Peanut particles were collected from the fit surfaces of the dentures and the gauzes, and weighed to evaluate the mass of food particles that had migrated under the denture (keeping the particles associated with the upper and lower dentures separate).|Up to 17 days|Analysis for this outcome was performed on ITT population including all participants who were randomized, received at least one dose of study treatment and had at least one post baseline efficacy assessment.|||gram (g)||Standard Deviation|Mean
2546260|NCT02928029|Primary|Phase 1: The Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Drug-related TEAEs, and Treatment-emergent Serious AE|A treatment-emergent adverse event (TEAE) is defined as any event arising or worsening after start of study drug administration until the end of the treatment period|From the start of study drug (radium-223 dichloride) to 30 days after last dose of study treatment (radium-223 dichloride, BOR, or DEX, whichever is last), assessed up to approximately 2 years|The safety analysis set including all participants who received at least one administration of study treatment|||Participants|||Count of Participants
2546342|NCT02926209|Secondary|Polyp Miss Rates (PMR) for Each Study Arm|Determined by second pass colonoscopy - lesions detected in second pass represent lesions missed during first pass|Through study completion, an average of one year||||missed polyps|||Number
2546262|NCT02928029|Secondary|Phase 1: The Number of Subjects With Complete Response (CR) and Very Good Partial Response (VGPR)|"Determined by International Myeloma Working Group (IMWG) uniform response criteria.~CR: Negative immunofixation of serum and urine, disappearance of any soft-tissue plasmacytomas, and <5% plasma cells in bone marrow; in patients for whom only measurable disease is by serum free light chain (FLC) level, normal FLC ratio of 0.26 to 1.65 in addition to CR criteria is required; 2 consecutive assessments are needed.~VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-component plus urine M-component <100 mg/24 hours (hrs); in patients for whom only measurable disease is by serum FLC level, >90% decrease in difference between involved and uninvolved FLC levels, in addition to VGPR criteria, is required; 2 consecutive assessments are needed"|Up to approximately 2 years|The safety analysis set including all participants who received at least one administration of study treatment|||Participants|||Count of Participants
2546263|NCT02927938|Primary|2 Year Relapse Free Survival (RFS)|Comparison of 2 year RFS in patient with detectable LSCs in the marrow at the end of consolidation to the 2 year RFS of patients without detectable LSCs. IWG Criteria (Cheson 2003) was utilized to classify relapse, with relapse defined as ≥ 5% blasts in the marrow or peripheral blood, extramedullary disease, or disease presence determined by a physician upon clinical assessment.|2 years|The primary efficacy analyses will be conducted on the subset of subjects who were included in the evaluable cohort (HCT or chemo treatment arm) and who also had a successful/interpretable end of consolidation eLSC assay. This excludes subjects in OC1 and 2, as they did not achieve CR to induction or did not have the immunophenotype of interest.|||Participants|||Count of Participants
2546264|NCT02927795|Secondary|Patient Satisfaction With Handling of the Respimat® Inhalation Device|A patient satisfaction questionnaire on how satisfied they were with handling of the Respimat® inhalation device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied).|After approx. 6 weeks (visit 2) of treatment initiation|FAS|||Participants|||Count of Participants
2546265|NCT02927795|Secondary|Patient Satisfaction With Inhaling From the Respimat® Device|A patient satisfaction questionnaire on how satisfied they were by inhaling with the Respimat® device was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied).|After approx. 6 weeks (visit 2) of treatment initiation|FAS|||Participants|||Count of Participants
2546266|NCT02927795|Secondary|Patient Overall Satisfaction With Spiolto® Respimat® at Visit 2|A patient satisfaction questionnaire on how overall satisfied they were with the Spiolto® Respimat® treatment was also completed during visit 2, using a 7-point ordinal scale, from 1 (very unsatisfied) to 7 (very satisfied).|After approx. 6 weeks (visit 2) of treatment initiation|FAS who completed the questionnaire.14 patients with missing data were excluded from the analysis.|||Participants|||Count of Participants
2546267|NCT02927795|Secondary|Patients General Condition Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2|The patient's general condition was evaluated by means of Physician's Global Evaluation (PGE) score. The PGE score is documented on a scale from 1 (poor) to 8 (excellent) at both visits. 1-2: poor; 3-4: satisfactory; 5-6: good; 7-8: excellent|Baseline (visit 1) and after approx.week 6 (visit 2)|FAS|||Participants|||Count of Participants
2546268|NCT02927795|Secondary|The Mean Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2|"The change in Physical functioning questionnaire (PF-10 ) score was determined by taking into account the individual change of each patient between Baseline (Visit 1) and Week 6 (approx.) (Visit 2) and then the mean for change from baseline values across all patients was calculated.~The PF-10 consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with yes, limited a lot, yes, limited a little or no, not limited at all, with a score of 1, 2 or 3. The sum of the scores of the 10 questions results in a value between 10 (a patient answering all questions with yes, limited a lot) and 30 (a patient answering all questions with no, not limited at all). The final sum of the individual scores was standardized to a range of 0 to 100 using the following formula: [(sum of scale items - 10) * 100] / 20.~Higher scores indicate better physical functioning."|Baseline (visit 1) and after approx. week 6 (visit 2)|FAS|||Unit on scale||Standard Deviation|Mean
2546269|NCT02927795|Primary|Percentage of Patients With Therapeutic Success at Week 6 Approximately (Approx.) (Visit 2)|"Therapeutic success defined as at least 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment. The PF-10 used for assessing the primary outcome physical functioning is a subdomain of the validated Short Form 36 (SF-36 ) and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with yes, limited a lot, yes, limited a little or no, not limited at all, with a score of 1, 2 or 3. The sum of the scores of the 10 questions results in a value between 10 (a patient answering all questions with yes, limited a lot) and 30 (a patient answering all questions with no, not limited at all). The final sum of the individual scores was standardized to a range of 0 to 100 using the following formula: [(sum of scale items - 10) * 100] / 20.~Higher scores indicate better physical functioning."|After approximately 6 weeks (visit 2)|Full Analysis Set (FAS): All screened patients with at least one documented administration of Spiolto® Respimat® and available PF-10 score at visit 1 and visit 2.|||Percentage of Patients (%)||95% Confidence Interval|Number
2546270|NCT02927457|Secondary|Mean Fold Change in Messenger Ribonucleic Acid (mRNA) Expression of Interferon (IFN) Signatures in Skin Biopsies|"Microarray mRNA data was collected from the skin biopsy in both GSK2646264 and placebo treated lesions on Day -5 to -3 visit (Baseline) and Day 28. Fold change represents the change at Day 28 relative to Baseline for each treatment group. Analysis was conducted using mixed model with participant as a random effect and treatment as a fixed effect where treatment is set to not applicable at Baseline. Mean fold change and 95% confidence interval is presented for different genes and probesets. IFI16 indicated interferon, gamma-inducible protein 16, IFI44 indicated interferon-induced protein 44, IFIH1 indicated interferon induced with helicase C domain 1, IFIT1 and 3 indicated interferon-induced protein with tetratricopeptide repeats 1 and 3, MX1 indicated myxovirus (influenza virus) resistance 1, interferon-inducible protein p78 (mouse), MX2 indicated myxovirus (influenza virus) resistance 2 (mouse) and OAS indicated 2'-5'-oligoadenylate synthetase."|Baseline (Day -5 to -3) and Day 28|Safety Population. Only those participants with data available at the specified data points were analyzed. Data was not collected for Group A as no participants were dosed.|||Fold change||95% Confidence Interval|Mean
2546271|NCT02927457|Secondary|Time to Reach Maximum Observed Concentration (Tmax) of GSK2646264 in Participants With CLE|Blood samples were collected at designated timepoints and PK analysis was performed. Tmax was calculated by non-compartmental analysis using WinNonlin.|Day 1 (pre-dose and 5 hours post-dose), Day 2 to Day 13, Day 14 (pre-dose), Day 21 to Day 27, Day 28 (post-dose), Day 29 to Day 42 and Follow-up (up to Day 56)|PK Population. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined. Data was not collected for Group A as no participants were dosed.|||Hours||Full Range|Median
2546272|NCT02927457|Secondary|Maximum Observed Concentration (Cmax) of GSK2646264 in Participants With Cutaneous Lupus Erythematosus (CLE)|Blood samples were collected at designated timepoints and pharmacokinetic (PK) analysis was performed. Cmax was calculated by non-compartmental analysis using WinNonlin. PK Population comprised of all participants in the safety population for whom a PK sample was obtained and analyzed.|Day 1 (pre-dose and 5 hours post-dose), Day 2 to Day 13, Day 14 (pre-dose), Day 21 to Day 27, Day 28 (post-dose), Day 29 to Day 42 and Follow-up (up to Day 56)|PK Population. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined. Data was not collected for Group A as no participants were dosed.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2546273|NCT02927457|Secondary|Change From Baseline in Erythema, Scaling Hyperkeratosis, Edema/Infiltration, Dyspigmentation, Modified Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index (RCLASI) Activity Score and Overall RCLASI Modified Score.|The score ranges for different components were; erythema [0 (absent) to 3 (dark red, purple/violaceous/crusted/hemorrhagic)], scaling/hyperkeratosis [0 (absent) to 2 (verrucous hyperkeratosis)], edema/infiltration [0 (absent) to 2 (palpable and visible)] and dyspigmentation [0 (absent) to 2 (hypo and hyper pigmentation)]. For all components, 0 (better) and 3 (worse). Modified RCLASI activity score was derived by adding score for erythema, scaling hyperkeratosis and edema/infiltration. Modified change from Baseline ranged from -7 to 7, 0 (no change), minus (better) and positive (worse). Overall RCLASI modified score was derived by summing the activity and dyspigmentation scores. Overall change from Baseline ranged from -9 to 9, 0 (no change), minus (better) and positive (worse). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data was not collected for Group A as no participants were dosed.|Baseline (Day 1), Day 14 and Day 28|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.|||Scores on a scale||Standard Deviation|Mean
2546274|NCT02927457|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function.|Up to Day 56|Safety Population. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined. Data was not collected for Group A as no participants were dosed.|||Participants|||Count of Participants
2546275|NCT02927457|Primary|Change From Baseline in ECG; PR Interval, QRS Duration, QT Interval and QTcF|Triplicate 12-lead ECGs were obtained using an ECG machine that automatically measured PR, QRS, QT, and QT interval corrected using Fridericia's formula (QTcF) intervals. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.|Baseline (Day 1), Day 14 and follow-up (up to Day 56)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). Data was not collected for Group A as no participants were dosed.|||Milliseconds||Standard Deviation|Mean
2546276|NCT02927457|Primary|Change From Baseline in Electrocardiogram (ECG); HR|Triplicate 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.|Baseline (Day 1), Day 14 and follow-up (up to Day 56)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). Data was not collected for Group A as no participants were dosed|||bpm||Standard Deviation|Mean
2546277|NCT02927457|Primary|Number of Participants With Emergent Vital Sign Results by PCI Criteria|Vital signs such as diastolic blood pressure (DBP), heart rate (HR) and systolic blood pressure (SBP) were measured in semi-supine position after 5 minutes rest for the participants. PCI ranges were SBP (lower: <85 millimeters of mercury [mmHg] and upper: >160 mmHg), DBP: (lower: <45 mmHg and upper: >100 mmHg) and HR (lower: <40 beats per minute [bpm] and upper: >110 bpm). All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.|Day 14 and Day 28|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). Data was not collected for Group A as no participants were dosed|||Participants|||Count of Participants
2546287|NCT02927431|Secondary|Change From Baseline in Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Alkaline Phosphatase (ALP)|Blood samples were collected to evaluate ALT, AST and ALP at indicated time points. Values at Day 1 were considered as Baseline values. Change from Baseline at each visit was calculated by subtracting Baseline value from post-dose visit value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data is not available.|Baseline and up to 45 days|Safety Population|||International unit per Liter (IU/L)||Standard Deviation|Mean
2546401|NCT02923830|Secondary|Central Line-Associated Blood Stream Infection (CLABSI)|Any laboratory-confirmed blood stream infection that is considered central line associated will be recorded.|baseline to 1 year|Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.||||||
2546278|NCT02927457|Primary|Change From Baseline in Urine Specific Gravity|Urine samples were collected to monitor the specific gravity. Specific gravity is a measure of urine concentration and is measured using a chemical test. Specific gravity measurements provide a comparison of the amount of substances dissolved in urine as compared to pure water. If there were no solutes present, the specific gravity of urine would be 1.000 the same as pure water. Specific gravity between 1.002 and 1.035 could be considered as normal. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.|Baseline (Day 1), Day 14, Day 28 and follow-up (up to Day 56)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). Data was not collected for Group A as no participants were dosed|||kilogram per meter cube||Standard Deviation|Mean
2546279|NCT02927457|Primary|Change From Baseline in Urine Potential of Hydrogen (pH)|Urine samples were collected to monitor the pH. pH is a measure of hydrogen ion concentration and is used to determine the acidity or alkalinity of urine. pH scale ranges from 0 to 14. A neutral pH is 7.0. The higher number indicates the more basic (alkaline) nature of urine and lower number indicates the more acidic urine. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.|Baseline (Day 1), Day 14, Day 28 and follow-up (up to Day 56)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). Data was not collected for Group A as no participants were dosed|||pH||Standard Deviation|Mean
2546280|NCT02927457|Primary|Number of Participants With Emergent Hematology Results by PCI Criteria|PCI ranges were hematocrit [Hct] (high: >0.54 proportion of red blood cell [RBC] in blood), hemoglobin [Hb] (high: >180 grams per liter), RBC (low: <4.2x10^12 cells per liter and high: >5.9x10^12 cells per liter), lymphocytes [Lympho] (low: <0.8x10^9 cells per liter), monocytes [Mono] (low: <0.14x10^9 cells per liter and high: >1.3x10^9 cells per liter), neutrophils [Neutro] (low: <1.5x10^9 cells per liter), platelet count [PC] (low: <100x10^9 cells per liter and high: >550x10^9 cells per liter), eosinophils [Eos] (high: >0.55x10^9 cells per liter), basophils [Baso] (high: >0.22x10^9 cells per liter), white blood cell [WBC] (low: <3x10^9 cells per liter and high: >20x10^9 cells per liter). All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.|Day 14, Day 28 and follow-up (up to Day 56)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). Data was not collected for Group A as no participants were dosed.|||Participants|||Count of Participants
2546281|NCT02927457|Primary|Number of Participants With Emergent Chemistry Results by Potential Clinical Importance (PCI) Criteria|Blood samples were collected to analyze the clinical chemistry parameters; albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TB), calcium, glucose, potassium (Pot) and sodium. PCI ranges were albumin (low: <30 grams per liter), calcium (low: <2 millimoles per liter [mmol/L] and high: >2.75 mmol/L), glucose (low: <3 mmol/L and high: >9 mmol/L), Pot (low: <3 mmol/L and high: >5.5 mmol/L), sodium (low: <130 mmol/L and high: >150 mmol/L), ALT (high: >=2 times upper limit of normal [ULN] units per liter {U/L}), AST (high: >=2 times ULN U/L), ALP (high: >=2 times ULN U/L) and TB (high: >=1.5 times ULN micromoles per liter). Safety Population comprised of all participants who received at least one dose of study treatment. All participants received both treatment interventions at the same time (on different skin sites), hence data for these participants were combined.|Day 14, Day 28 and follow-up (up to Day 56)|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). Data was not collected for Group A as no participants were dosed.|||Participants|||Count of Participants
2546282|NCT02927431|Secondary|Average Concentration (Cavg) of IV DNX|Cavg of IV DNX was to be derived from the PK samples collected at Day 1 pre-dose, Day 3 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose and Day 5 pre-dose.|Day 1 pre-dose, Day 3 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose and Day 5 pre-dose|PK Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed due to limited sample size.||||||
2546283|NCT02927431|Secondary|Time to Reach Cmax (Tmax) of IV DNX|Tmax of IV DNX was to be derived from the PK samples collected at Day 1 pre-dose, Day 3 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose and Day 5 pre-dose.|Day 1 pre-dose, Day 3 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose and Day 5 pre-dose|PK Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed due to limited PK parameters available.||||||
2546284|NCT02927431|Secondary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC [0-t]) of IV DNX|AUC (0-t) of IV DNX was to be derived from the PK samples collected at Day 1 pre-dose, Day 3 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose and Day 5 pre-dose.|Day 1 pre-dose, Day 3 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose and Day 5 pre-dose|PK Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed due to limited sample size.||||||
2546285|NCT02927431|Secondary|Maximum Observed Plasma Concentration (Cmax) of Intravenous (IV) DNX|Cmax of IV DNX was to be derived from the Pharmacokinetics (PK) samples collected at Day 1 pre-dose, Day 3 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose and Day 5 pre-dose. PK Population comprised of all participants who underwent blood PK sampling during the study and from whom one or more blood concentration was determined.|Day 1 pre-dose, Day 3 at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 8 and 12 hours post-dose and Day 5 pre-dose|PK Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed due to limited sample size.||||||
2546286|NCT02927431|Secondary|Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)|Single 12-lead ECGs were obtained at Baseline and on the day of last dose during the study using an ECG machine that automatically calculates the heart rate (HR) and measures PR, QRS, QT, and QT duration corrected for heart rate (QTc). Number of participants with clinically significant abnormality in ECG are presented.|Up to 6 days|Safety Population|||Participants|||Count of Participants
2546288|NCT02927431|Secondary|Change From Baseline in Total Bilirubin (T. Bilirubin), Creatinine and Direct Bilirubin (D. Bilirubin)|Blood samples were collected to evaluate T. Bilirubin, creatinine and D. Bilirubin at indicated time points. Values at Day 1 were considered as Baseline values. Change from Baseline at each visit was calculated by subtracting Baseline value from post-dose visit value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data is not available.|Baseline and up to 45 days|Safety Population|||Micromole per Liter (µmol/L)||Standard Deviation|Mean
2546289|NCT02927431|Secondary|Change From Baseline in White Blood Cell Count (WBC) and Absolute Neutrophil Count (ANC)|Blood samples were collected to evaluate WBC and ANC at indicated time points. Values at Day 1 were considered as Baseline values. Change from Baseline at each visit was calculated by subtracting Baseline value from post-dose visit value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data is not available.|Baseline and up to 45 days|Safety Population|||Giga cells per Liter (GI/L)||Standard Deviation|Mean
2546290|NCT02927431|Secondary|Change From Baseline in Albumin and Total Protein|Blood samples were collected to evaluate albumin and total protein at indicated time points. Values at Day 1 were considered as Baseline values. Change from Baseline at each visit was calculated by subtracting Baseline value from post-dose visit value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data is not available.|Baseline and up to 45 days|Safety Population|||Gram per Liter (G/L)||Standard Deviation|Mean
2546291|NCT02927431|Secondary|Number of Participants With Any Non-serious Adverse Event (AE); Any Serious AE (SAE); Any AEs of Special Interest (AESIs)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Participants who received any of the study treatment and had any AE or SAE or AESI were considered for analysis. Safety Population comprised of all participants who received at least 1 dose of study treatment.|Up to 45 Days|Safety Population|||Participants|||Count of Participants
2546292|NCT02927431|Secondary|Number of Participants With Improvement in Ordinal Scale of Clinical Efficacy Over Time|Number of participants with improvement in ordinal scale of clinical efficacy over time was to be assessed by: death, mechanical vent, in the ICU, non-ICU hospitalization, and hospital discharge.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
2546293|NCT02927431|Secondary|Number of Participants Used Antibiotics for Complications of Influenza|Complications of influenza such as bacterial pneumonia, pneumothorax, pleural effusion, acute respiratory distress syndrome (ARDS), myositis, encephalitis, myocarditis, and associated antibiotic use was recorded. Number of participants who reqruied use of associated antibiotics for complications of influenza is presented.|Up to 45 Days|IPP Population|||Participants|||Count of Participants
2546294|NCT02927431|Secondary|Number of Participants With Development of Septic Shock|Development of septic shock was to be assessed by occurrence of hypotension requiring vasopressive therapy and serum lactate level >2 millimeter (mm) after adequate fluid resuscitation. Number of participants with development of septic shock were planned to be presented.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
2546295|NCT02927431|Secondary|Number of Days of Stay in the Hospital|Number of days of stay in the hospital over treatment period and post treatment period was to be recorded.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
2546296|NCT02927431|Secondary|Number of Participants Requiring ICU Admission and Readmission|Number of participants requiring ICU admission during treatment period and after post treatment was to be recorded.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
2546297|NCT02927431|Secondary|Number of Days of Stay in the Intensive Care Unit (ICU)|Number of days of stay in the ICU over the treatment period and post treatment period was to be recorded.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
2546298|NCT02927431|Secondary|Time to Improvement of Ventilation Status|Time to improvement of ventilation status was assessed by modality, frequencies and durations of invasive and non-invasive ventilator support, duration of oxygen supplementation.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
2546299|NCT02927431|Secondary|Percentage of Participants With Improved Respiratory Status Over Time|The Respiratory Response was defined as meeting at least one of the following criteria, and maintained for 24 hours: return to pre-morbid oxygen requirement (participants with chronic oxygen use or ventilator support), or return to no requirement of supplemental oxygen, or respiratory rate <=24 per minute (without supplemental oxygen). Percentage of participants with improved respiratory status has been presented.|Up to 45 Days|IPP Population|||Percentage of Participants|||Number
2546300|NCT02927431|Secondary|Percentage of Participants With Clinical Response Over Time|The clinical response was defined as Hospital discharge due to clinical improvement OR normalization of temperature; and oxygen saturation; and respiratory status/heart rate/systolic blood pressure (normalization of 2 out of these 3 parameters). The clinical response based on vital signs/ventilation status required 24-hour confirmation. Considering 2-hour assessment window, the response confirmation period was 22 hours. Percentage of participants with positive clinical response are presented.|Up to 45 Days|IPP Population|||Percentage of Participants|||Number
2551092|NCT02821962|Other Pre-specified|Changes in Body Weight|Changes in body weight (kg)|baseline and 8 weeks|Includes participants with complete data on body weight from baseline and 8 weeks.|||kilograms||Standard Deviation|Mean
2546303|NCT02927431|Secondary|Time to Improved Oxygen Saturation|Time from first dose of treatment to time of improved oxygen saturation was to be calculated. A participant with a history of chronic hypoxia (without supplemental oxygen) satisfied normalization criteria for oxygen saturation if the value (without supplemental oxygen) is <=2 percent from participant's historical oxygen saturation Baseline as recorded within 12 months prior to enrollment as documented in the participant's medical records. This requirement was to be waived for participants with a history of chronic supplemental oxygen requirement who had a Baseline oxygen saturation <95 percent with supplemental oxygen, within 12 months prior to enrollment as documented in the participant's medical records.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
2546304|NCT02927431|Secondary|Time to Absence of Fever|Time from first dose of treatment to time to afebrile status (<=36.6 degree celsius-axilla/temporal or <=37.2 degree celsius- oral, or <=37.7 degree celsius-rectal/core, tympanic) was to be evaluated.|Up to 45 Days|IPP Population. As the study was terminated, only a selected set of originally planned analysis were performed and hence this endpoint was not analyzed.||||||
2546305|NCT02927431|Secondary|Time to Respiratory Response (TTRR)|Time to Respiratory Response was defined as meeting at least one of the following criteria, and maintained for 24 hours: return to pre-morbid oxygen requirement (participants with chronic oxygen use or ventilator support), or return to no requirement of supplemental oxygen, or respiratory rate <=24 per minute (without supplemental oxygen). Kaplan Meier estimates for the median of TTRR for each treatment group was provided. NA indicates data is not available. Due to limited data, no TTRR estimate could be calculated for any of the treatment groups.|Up to 45 Days|IPP Population|||Days||Inter-Quartile Range|Median
2546306|NCT02927431|Primary|Time to Clinical Response (TTCR)|The clinical response was defined as Hospital discharge due to clinical improvement OR normalization of temperature; and oxygen saturation; and respiratory status/heart rate/systolic blood pressure (normalization of 2 out of these 3 parameters). The clinical response based on vital signs/ventilation status required 24-hour confirmation. Considering 2-hour assessment window, the response confirmation period was 22 hours. Kaplan Meier estimates for the median of TTCR was provided. One participant had vital sign resolution at Baseline and was counted as having a clinical response but was not included in the Kaplan Meier Estimates. Influenza Positive Population (IPP) Population comprised of all participants in the Intent to Treat Exposed (ITT-E) Population with influenza infection (positive influenza Polymerase Chain Reaction [PCR] or culture at any time point) confirmed by central lab testing. Only those participants with data available at the indicated time point were analyzed.|Up to 45 Days|IPP Population|||Days||Inter-Quartile Range|Median
2546307|NCT02927366|Secondary|Area Under the Plasma Concentration Time Curve From 0 to the End of a Dosing Interval (AUCtau) for QCC374 and Its Metabolite QCM441|AUCtau is the area under the plasma concentration-time curve from time zero to the end of the dosing interval. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed.|Day 1 and 112 (0.00, 0.05, 0.15, 0.30, 1.00, 2.00, 4.00, 8.00 and 12.00 hours post-dose))|Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2546308|NCT02927366|Secondary|Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (AUClast) for QCC374 and Its Metabolite QCM441|AUClast is the area under the plasma concentration-time curve from time zero to the last measurable concentration sampling time. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed.|Day 1 and 112 (0.00, 0.05, 0.15, 0.30, 1.00, 2.00, 4.00, 8.00 and 12.00 hours post-dose))|Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2546309|NCT02927366|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) for QCC374 and Its Metabolite QCM441|Tmax is the time to reach maximum plasma concentration after single dose administration. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed.|Day 1 and 112 (0.00, 0.05, 0.15, 0.30, 1.00, 2.00, 4.00, 8.00 and 12.00 hours post-dose))|Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered.|||hour||Full Range|Median
2546310|NCT02927366|Secondary|Maximum Observed Plasma Concentration (Cmax) for QCC374 and Its Metabolite QCM441|Cmax is the maximum (peak) observed plasma drug concentration after single dose administration. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed.|Day 1 and 112 (0.00, 0.05, 0.15, 0.30, 1.00, 2.00, 4.00, 8.00 and 12.00 hours post-dose))|Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2546311|NCT02927366|Secondary|Change From Baseline in Tricuspid Annular Plane Sys Excursion (TAPSE) at Week 16 (Day 111) Using Echocardiography|Key Right Ventricular (RV) function endpoints such as Tricuspid Annular Plane Sys Excursion (TAPSE) were assessed with echocardiography. A higher number in TAPSE indicates an improvement. Only descriptive analysis performed.|Baseline, Week 16 (Day 111)|Participants from the Pharmacodynamic (PD) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PD assessment, with data available for analysis were considered.|||cm||Standard Deviation|Mean
2546312|NCT02927366|Secondary|Change From Baseline in Tricuspid Annular Peak Systolic Velocity (TA S') at Week 16 (Day 111) Using Echocardiography|Key Right Ventricular (RV) function endpoints such as Tricuspid Annular Peak Systolic Velocity (TA S') were assessed with echocardiography. Only descriptive analysis performed.|Baseline, Week 16 (Day 111)|Participants from the Pharmacodynamic (PD) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PD assessment, with data available for analysis were considered.|||cm/s||Standard Deviation|Mean
2546313|NCT02927366|Secondary|Change From Baseline in RV Tei Index at Week 16 (Day 111) Using Echocardiography|Key Right Ventricular (RV) function endpoints such as Tei Index were assessed with echocardiography. The RV Tei index is using both systolic and diastolic time intervals to evaluate the overall global dysfunction of the right ventricle in PAH patients. A lower number in RV Tei Index indicates an improvement. Only descriptive analysis performed.|Baseline, Week 16 (Day 111)|Participants from the Pharmacodynamic (PD) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PD assessment, with data available for analysis were considered.|||Index||Standard Deviation|Mean
2546314|NCT02927366|Secondary|Change From Baseline in RV Fractional Area Change and RV Free Wall Average Peak Long Strain at Week 16 (Day 111) Using Echocardiography|Key Right Ventricular (RV) function endpoints such as RV fractional area change (RV FAC) and RV Free Wall Average Peak Long Strain (RV FWPLS) were assessed with echocardiography. A higher number in RV FAC and a lower number in RV FWPLS indicate an improvement. Only descriptive analysis performed.|Baseline, Week 16 (Day 111)|Participants from the Pharmacodynamic (PD) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PD assessment, with data available for analysis were considered.|||Percentage||Standard Deviation|Mean
2546315|NCT02927366|Secondary|Change From Baseline in Systemic Vascular Resistance (SVR) at Week 16 (Day 111)|The Right Heart Catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including Systemic Vascular Resistance (SVR). All hemodynamic parameters were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive CO measurements within 10% of each other) while the patient was breathing ambient air or oxygen. SVR is derived from the CO measurement in dyn·s/cm5 and can be calculated as 80 multiplied by (Mean Arterial Pressure - Mean Venous Pressure or CVP)) divided by Cardiac Output. A higher negative number in Mean Systemic Vascular Resistance indicates improvement. Only descriptive analysis performed.|Baseline, Week 16 (Day 111)|Participants from the Pharmacodynamic (PD) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PD assessment, with data available for analysis were considered.|||dynes*Sec*cm5||Standard Deviation|Mean
2546316|NCT02927366|Secondary|Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Week 16 (Day 111)|The Right Heart Catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including mean Pulmonary Capillary Wedge Pressure (PCWP). All hemodynamic parameters were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive CO measurements within 10% of each other) while the patient was breathing ambient air or oxygen. Pressure measurements were made in the PA, PA wedge, right ventricle (RV) and right atrium (RA) and determined at the end of normal expiration. The PCWP was recorded as the mean of three measurements. Only descriptive analysis performed.|Baseline, Week 16 (Day 111)|Participants from the Pharmacodynamic (PD) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PD assessment, with data available for analysis were considered.|||mmHg||Standard Deviation|Mean
2546317|NCT02927366|Secondary|Change From Baseline in Cardiac Index at Week 16 (Day 111)|The Right Heart Catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including Cardiac Index. All hemodynamic parameters were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive CO measurements within 10% of each other) while the patient was breathing ambient air or oxygen. A higher negative number in Cardiac Index indicates improvement. Only descriptive analysis performed.|Baseline, Week 16 (Day 111)|Participants from the Pharmacodynamic (PD) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PD assessment, with data available for analysis were considered.|||L/min/m2||Standard Deviation|Mean
2546318|NCT02927366|Secondary|Change From Baseline in Cardiac Output (CO) at Week 16 (Day 111)|The Right Heart Catheterization (RHC) assessment was performed to assess several hemodynamic variables in pulmonary hypertension, including Cardiac Output (CO). All hemodynamic parameters were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive CO measurements within 10% of each other) while the patient was breathing ambient air or oxygen. CO was measured in triplicate using the thermodilution technique. Direct Fick could be used only after discussion and approval by the Sponsor. In all cases, the same technique was to be used at baseline and week 16. . A higher positive number in Cardiac Output indicates improvement. Only descriptive analysis performed.|Baseline, Week 16 (Day 111)|Participants from the Pharmacodynamic (PD) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PD assessment, with data available for analysis were considered.|||L/min||Standard Deviation|Mean
2546319|NCT02927366|Secondary|Change From Baseline in Six Minute Walk Distance (6MWD) Over Time|The Six Minute Walk Test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. Only descriptive analysis performed.|Baseline, Day 28, Day 56, Day 84 and Day 111|Participants from the Pharmacodynamic (PD) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PD assessment, with data available for analysis were considered.|||Meter||Standard Deviation|Mean
2546320|NCT02927366|Primary|Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 16 (Day 111)|The efficacy of 16 weeks of QCC374 administration in subjects with Pulmonary Arterial Hypertension (PAH) was assessed by measuring changes from baseline in Pulmonary Vascular Resistance (PVR). PVR is derived from the CO measurement in dyn·s/cm5 and can be calculated as 80 multiplied by (Mean Arterial Pressure - Mean Pulmonary Artery Wedge Pressure) divided by Cardiac Output. A higher negative number in Pulmonary Vascular Resistance indicates improvement. Only descriptive analysis performed.|Baseline, Week 16 (Day 111)|Participants from the Pharmacodynamic (PD) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PD assessment, with data available for analysis were considered.|||dyn*s/cm5||Standard Deviation|Mean
2546321|NCT02927327|Other Pre-specified|Summary of Safety Information|Number of safety events (AEs and SAEs).|through study completion, an average of 2 months|||||||
2551299|NCT02819804|Secondary|Peripheral T-cell Levels and Activation in Response to Treatment|T-cell levels and activation will be measured in the peripheral blood after treatment.|At cycle 1 days: 1, 2, 8, 15, & 22 prior to dosing|||||||
2546324|NCT02927327|Secondary|Determination of Diagnostic Acceptability|Site level determination of diagnostic acceptability (Y/N) based on consensus between radiologist(s) and nuclear medicine physician(s) at the site. Diagnostic acceptability in the form of binary responses (Y/N) were collected from 61 subjects who completed the study.|through study completion, an average of 2 months|Diagnostic acceptability in the form of binary responses (Y/N) were collected from 61 subjects who completed the study.|||Participants|||Count of Participants
2546325|NCT02927327|Primary|Diagnostic Image Quality|"scored on a 5-pt Likert scale:~Unacceptable~Poor~Acceptable~Good~Excellent"|through study completion, an average of 2 months|Subjects that had a clinical indication for PET/CT or PET/MR with radiotracer injection prescribed for their medical care outside of the study.|||scores on a scale||Standard Deviation|Mean
2546326|NCT02927223|Primary|Number of Ventricular Ectopic Beats Recorded During Exercise (and Recovery)||20 minutes during exercise||||number of ventricular beats||Full Range|Median
2546327|NCT02927171|Other Pre-specified|Patient Satisfaction Survey|8 Question survey, scoring each questions on a 1-10 scale (1=not at all, 10=extremely). Higher scores indicate higher satisfaction.|Quantification at SNF Discharge (Expected average length of stay: 21 days)||||score on a scale||Standard Deviation|Mean
2546328|NCT02927171|Secondary|Gait Speed|Time it takes to walk a 4 meter path. Lower scores indicate better function.|Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)||||seconds||Standard Deviation|Mean
2546329|NCT02927171|Primary|Short Physical Performance Battery (SPPB)|Global measure of lower extremity function, which consists of walking speed, chair stands, and balance tests. Minimum scores are 0 and maximum scores are 12. Higher scores indicate better function.|Change from SNF Admission to SNF Discharge (Expected average length of stay: 21 days)||||score on a scale||Standard Deviation|Mean
2546330|NCT02926638|Other Pre-specified|Treatment Arm Randomization Acceptance Rate|Monitored by the percentage of patients that receive at least one dose of the treatment they are randomized to.|Up to 3 years|This study was terminated early and thus no manuscript is forthcoming. Outcomes were not analyzed.||||||
2546331|NCT02926638|Secondary|Frequency and Severity of Toxicities Associated With Investigational Therapy Versus Standard of Care||Up to 3 years|This study was terminated early and thus no manuscript is forthcoming. Outcomes were not analyzed.||||||
2546332|NCT02926638|Primary|Objective Response Rate (Confirmed and Unconfirmed, Complete and Partial) Between Arms||Up to 3 years|This study was terminated early and thus no manuscript is forthcoming. Outcomes were not analyzed.||||||
2546333|NCT02926638|Primary|Investigator-assessed Progression-free Survival Between Arms|A stratified (using randomization stratification factors) log-rank test will be used to test the primary hypotheses related to investigator-assessed progression-free survival, comparing the two treatment arms.|From date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 18 months since completion of accrual|This study was terminated early and thus no manuscript is forthcoming. Outcomes were not analyzed.||||||
2546334|NCT02926573|Secondary|Mean Pain With Swallowing Score as Measured by VAS|"Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to Please rate your current pain level with no movement (rest), with a cough, and with a swallow. Subjects marked a point on a 100-mm line anchored no pain on the left end and worst possible pain on the right end.~Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the >70 range with severe pain"|Baseline through post operative day 3||||mm||Standard Deviation|Mean
2546335|NCT02926573|Secondary|Mean Pain With Coughing Score as Measured by VAS|"Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to Please rate your current pain level with no movement (rest), with a cough, and with a swallow. Subjects marked a point on a 100-mm line anchored no pain on the left end and worst possible pain on the right end.~Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the >70 range with severe pain"|Baseline through post operative day 3||||mm||Standard Deviation|Mean
2546336|NCT02926573|Secondary|Mean Pain With Resting Score as Measured by VAS|"Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to Please rate your current pain level with no movement (rest), with a cough, and with a swallow. Subjects marked a point on a 100-mm line anchored no pain on the left end and worst possible pain on the right end.~Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the >70 range with severe pain"|Baseline through post operative day 3||||mm||Standard Deviation|Mean
2546337|NCT02926573|Secondary|Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control|-A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.|Once on post-op day 2 or day of discharge, whichever comes first||||Participants|||Count of Participants
2546338|NCT02926573|Secondary|Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain|-A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.|Once on post-op day 2 or day of discharge, whichever comes first||||Participants|||Count of Participants
2546339|NCT02926573|Secondary|Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled|-A discharge survey to document patient satisfaction and perceived pain control was given at the time of the last VAS score.|Once on post-op day 2 or day of discharge, whichever comes first|The participants who did not answer this question on the survey were not evaluable for this outcome measure.|||Participants|||Count of Participants
2546340|NCT02926573|Primary|Change in Daily Narcotic Consumption|Total amount of narcotic use in morphine equivalents will be divided by the total hours of inpatient hospitalization, multiplied by 24 hours, to obtain the daily narcotic consumption.|Daily from date of randomization until post-op day 2 or date of discharge, whichever comes first.||||mg/hour||Full Range|Median
2546341|NCT02926209|Secondary|Advanced Adenoma Miss Rates (AAMR) for Each Study Arm|Determined by second pass colonoscopy - lesions detected in second pass represent lesions missed during first pass - adenomatic status based on histopathology.|Through study completion, an average of one year||||missed advanced adenomas|||Number
2546343|NCT02926209|Primary|Adenoma Miss Rates|"Determined by second pass colonoscopy - lesions detected in second pass represent lesions missed during first pass - adenomatic status based on histopathology.~Three (3) lesions were missed by the Aer-OScope and detected with the subsequent conventional colonoscopy. Two (2) polyps were not removed and an additional one (1) was not retrieved.~Data was missing for two (2) lesions by the Conventional Colonoscopy (CC)"|Through study completion, an average of one year||||missed adenomas|||Number
2546344|NCT02925858|Secondary|Time to Ambulation|Time from ICU arrival until patient able to ambulate, measured in hours|1 week postoperatively||||hours||95% Confidence Interval|Mean
2546345|NCT02925858|Secondary|Time to Mobilization|Time from ICU arrival until patient able to mobilize to chair, measured in hours|During hospital stay||||hours||95% Confidence Interval|Mean
2546346|NCT02925858|Secondary|Delirium|Delirium as assessed by a positive CAM-ICU score during the ICU stay|ICU stay||||Participants|||Count of Participants
2546347|NCT02925858|Secondary|Time to Extubation|Number of minutes from the time of ICU arrival to extubation|4 hours - 2 weeks||||minutes||95% Confidence Interval|Mean
2546348|NCT02925858|Secondary|Hospital Length of Stay|number of days spent in the hospital, starting from the day of surgery|5 days - 2 weeks||||days||Inter-Quartile Range|Median
2546349|NCT02925858|Secondary|Intensive Care Unit Length of Stay|Number of days spent in the intensive care unit|1 day - 2 weeks||||days||Inter-Quartile Range|Median
2546350|NCT02925858|Secondary|Postoperative Nausea and Vomiting|Whether or not the patient suffered from nausea and vomiting after surgery which required treatment|48 hours after ICU arrival||||Participants|||Count of Participants
2546351|NCT02925858|Secondary|Pain Scores (Visual Analog Scale)|Average Pain Score as reported by the patient on a numeric scale ranging from 0 (no pain) to a maximum of 10 points (worst pain imaginable)|Postoperative days 2||||score on a scale||Inter-Quartile Range|Median
2546352|NCT02925858|Secondary|Quantity of Opioids Used|Quantity in mg|24 hours postoperatively||||mg of Dilaudid||95% Confidence Interval|Mean
2546353|NCT02925858|Primary|Quantity of Opioids Used in the First 48 Hours Postoperatively|Opioids used, in Dilaudid equivalents|First 48 hours after arrival to the ICU||||mg of Dilaudid||95% Confidence Interval|Mean
2546354|NCT02925741|Secondary|Maximum Severity of Unit Acquired Pressure Injury (UAPI)|HAPI staged by trained clinical nurses using the National Pressure Advisory Panel (NPUAP) staging definitions in which Stage 1 is the least severe with severity progressing through Stage 2, 3, 4, and unstageable. Unstageable is an evolving type of pressure injury evolving into a Stage 3 or 4.|During MICU admission|For all patients, maximum stage of HAPI during medical intensive care unit (MICU) stay|||Participants|||Count of Participants
2546355|NCT02925741|Secondary|The Time to Develop the First Unit-acquired Pressure Ulcer|The number of days spent in the intensive care unit prior to the development of a pressure ulcer|Days from admission to HAPI|Number of days from admission to first HAPI for patients who developed a HAPI|||days||Inter-Quartile Range|Median
2546356|NCT02925741|Primary|Rate of Development of Unit-acquired Pressure Ulcers|Total count of the number of patients who developed unit acquired pressure ulcers during the study (count)|During MICU admission|Total count and percentage of patients who developed a hospital acquired pressure injury (HAPI)|||Participants|||Count of Participants
2546357|NCT02925611|Secondary|CAM-S Delirium Severity Score With Isoflurane and Desflurane|Comparison of CAM-S delirium severity score with isoflurane and desflurane. CAM-S delirium severity score ranges from 0 to 19 ( 0 being best outcome and 19 being worst outcome).|72 hours post surgery||||units on a scale||Inter-Quartile Range|Median
2546358|NCT02925611|Secondary|CAM-S Delirium Severity Score With Isoflurane and Desflurane|Comparison of CAM-S delirium severity score with isoflurane and desflurane. CAM-S delirium severity score ranges from 0 to 19 ( 0 being best outcome and 19 being worst outcome).|24 hours post surgery||||units on a scale||Inter-Quartile Range|Median
2546359|NCT02925611|Secondary|Post Operative Pain Scores With Isoflurane and Desflurane|Comparison of postoperative pain scores (measured by numerical rating score) with by isoflurane and desflurane. The numerical rating score ranges from 0 to 10 (0 being no pain and 10 being maximum subjective pain).|72 hours post surgery||||units on a scale||Inter-Quartile Range|Median
2546360|NCT02925611|Secondary|Post Operative Pain Scores With Isoflurane and Desflurane|Comparison of postoperative pain scores (measured by numerical rating score) with by isoflurane and desflurane. The numerical rating score ranges from 0 to 10 (0 being no pain and 10 being maximum subjective pain).|24 hours post surgery||||units on a scale||Inter-Quartile Range|Median
2546361|NCT02925611|Primary|Comparison of Postoperative Delirium With Isoflurane and Desflurane on Adults Undergoing Spine Surgery|Number of Participants who were Postoperative Delirium Positive (POD+) or Negative (POD-) After Undergoing Spine Surgery With Isoflurane or Desflurane using the confusion assessment method questionnaire on day three following surgery.|72 hours post surgery||||Participants|||Count of Participants
2546362|NCT02925611|Primary|Comparison of Postoperative Delirium(POD) With Isoflurane and Desflurane on Adults Undergoing Spine Surgery|Number of Participants who were Postoperative Delirium Positive (POD+) or Negative (POD-) After Undergoing Spine Surgery With Isoflurane or Desflurane using the confusion assessment method questionnaire on day one following surgery.|24 hours post surgery||||Participants|||Count of Participants
2546363|NCT02925403|Primary|Safety and Tolerability of R21/Matrix-M1 Assessed by the Occurrence of Laboratory Adverse Events.|Occurrence of laboratory adverse events defined as clinically significant changes from baseline. Haematology (Full Blood Count) and Biochemistry (Kidney and Liver Function Tests) will be assessed.|At Day 0 (baseline), day 7 and day 28 post vaccination.||||Laboratory AEs|||Number
2546364|NCT02925403|Primary|Safety and Tolerability of R21/Matrix-M1 Assessed by the Occurrence of Serious Adverse Events.|Occurrence of serious adverse events will be collected from enrolment until the end of the follow-up period.|6 months||||SAEs|||Number
2546365|NCT02925403|Primary|Safety and Tolerability of R21/Matrix-M1 Assessed by the Occurrence of Unsolicited Adverse Events.|Occurrence of unsolicited local and systemic adverse events. This will be done by recording the number of participants who experience unsolicited adverse events.|Unsolicited AEs to be assessed up to 28 days post vaccination.||||participants|||Number
2551300|NCT02819804|Secondary|PD1 Expression Levels and Saturation in Bone Marrow|Bone marrow will be assessed to measure PD1 expression levels and saturation.|Baseline to 28-days after the last dose|||||||
2546367|NCT02924883|Secondary|Percentage of Participants With ATAs to Trastuzumab Emtansine|ATAs are antibodies that inactivate the therapeutic effects of Trastuzumab Emtansine. Patients are considered to be ATA positive if they are ATA negative at baseline but develop an ATA response following study drug administration (treatment-induced ATA response), or if they are ATA positive at baseline and the titer of one or more post-baseline samples is at least 4-fold greater (i.e., ≥ 0.60 titer units) than the titer of the baseline sample (treatment-enhanced ATA response).|Pre-infusion (0 h) on Day 1 Cycles 1 and 4 (each cycle = 21 days); and at any time during study treatment/early discontinuation visit (approximately 40 months)||2021-11-30|11/2021||||
2546368|NCT02924883|Secondary|Percentage of Participants With Anti-therapeutic Antibodies (ATAs) to Atezolizumab|ATAs are antibodies that inactivate the therapeutic effects of Atezolizumab. Patients are considered to be ATA positive if they are ATA negative at baseline but develop an ATA response following study drug administration (treatment-induced ATA response), or if they are ATA positive at baseline and the titer of one or more post-baseline samples is at least 4-fold greater (i.e., ≥ 0.60 titer units) than the titer of the baseline sample (treatment-enhanced ATA response).|Pre-infusion (0 h) on Day 1 Cycles 1, 2, 3, 4, 8, and every 8 cycles thereafter (each cycle = 21 days) up to 120 days after treatment completion or early discontinuation (approximately 40 months)||2021-11-30|11/2021||||
2546369|NCT02924883|Secondary|Cycle 4 Cmax of Atezolizumab|Average post infusion atezolizumab concentration at Cycle 4|30 minutes after the end of Cycle 4 (each cycle = 21 days) of atezolizumab infusion|PK population included all participants who received at least one dose of trastuzumab emtansine with at least one post-dose concentration data point.|||ug/mL||Standard Deviation|Mean
2546370|NCT02924883|Secondary|Steady State Cmax of Total Trastuzumab||Pre-infusion (0 h), 30 min after EOI (over 90 min) on Day 1 Cycles 1 and 4; pre-infusion (0 h) on Day 1 Cycle 2 (each cycle = 21 days)|PK population included all participants who received at least one dose of trastuzumab emtansine with at least one post-dose concentration data point.|||ug/mL||Standard Deviation|Mean
2546371|NCT02924883|Secondary|Steady State Cmax of Deacetyl Mercapto 1-Oxopropyl Maytansine|Average post infusion Deacetyl Mercapto 1-Oxopropyl Maytansine concentration at Cycle 4 of trastuzumab emtansine infusion|30 minutes after the end of Cycle 4 (each cycle = 21 days) trastuzumab emtansine infusion|PK population included all participants who received at least one dose of trastuzumab emtansine with at least one post-dose concentration data point.|||ng/mL||Standard Deviation|Mean
2546372|NCT02924883|Secondary|Steady State Maximum Serum Concentration (Cmax) of Trastuzumab Emtansine|Average post infusion Trastuzumab Emtansine concentration at Cycle 4|30 minutes after the end of Cycle 4 (each cycle = 21 days) trastuzumab emtansine infusion|PK population included all participants who received at least one dose of trastuzumab emtansine with at least one post-dose concentration data point.|||ng/mL||Standard Deviation|Mean
2546373|NCT02924883|Secondary|Duration of OR as Determined by Investigator's Tumor Assessment Using RECIST v1.1|Duration of OR was defined as the time from the first tumor assessment that was judged to indicate that the patient had an objective response to the time of first documented disease progression using RECIST v1.1 per investigator assessment or death from any cause, whichever occurred first.|Baseline up to approximately 15 months|The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Participants with OR were considered for duration of OR.|||Months||95% Confidence Interval|Median
2546374|NCT02924883|Secondary|Percentage of Participants With Objective Response (OR) as Determined by Investigator's Tumor Assessment Using RECIST v1.1|An OR was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum. Participants who had no post-baseline tumor assessment were counted as non-responders.|Baseline up to approximately 15 months|The ITT population included all randomized participants grouped according to the treatment assigned at randomization. In Participants with baseline measurable disease were considered for OR. In the atezolizumab arm, one patient was not ORR evaluable.|||Percentage of participants|||Number
2546375|NCT02924883|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death from any cause.|Baseline up to study completion or death, whichever occurs first, approximately 40 months||2021-11-30|11/2021||||
2546376|NCT02924883|Primary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline up to study completion, approximately 40 months|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.|||percentage of participants|||Number
2546377|NCT02924883|Primary|Progression-Free Survival (PFS) as Determined by Investigator's Tumor Assessment Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)|PFS was defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeter (mm) or the appearance of one or more new lesions.|Baseline up to approximately 15 months|The intent-to-treat (ITT) population included all randomized participants grouped according to the treatment assigned at randomization.|||months||95% Confidence Interval|Median
2546378|NCT02924688|Secondary|Number of Participants With Abnormal Hematology Values|Blood samples were collected for assessment of hematology parameters, which included Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Platelets, Mean Corpuscular Hemoglobin (MCH) and Mean Corpuscular Volume (MCV). Abnormal laboratory results are categorized as high or low with respect to their normal ranges. Participants having High and Low values from normal ranges for any parameter at any time post-baseline visits are presented.|Up to Week 52|ITT Population. Only those participants with data available at the specified time point were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2546379|NCT02924688|Secondary|Number of Participants With Abnormal Clinical Chemistry Values|Blood samples were collected for assessment of clinical chemistry parameters, which included albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), direct bilirubin, total bilirubin, calcium, creatinine, glucose, potassium, protein, sodium and urea. Abnormal laboratory results are categorized as high or low with respect to their normal ranges. Participants having High and Low values from normal ranges for any parameter at any time post-baseline visits are presented.|Up to Week 52|ITT Population. Only those participants with data available at the specified time point were analyzed.|||Participants|||Count of Participants
2546380|NCT02924688|Secondary|Mean Change From Baseline in Pulse Rate at Week 24|Pulse Rate was measured in the sitting position after approximately 5 minutes rest. Baseline value is the last acceptable/borderline acceptable value prior to randomized treatment start date (pre-dose at Day 1). Change from Baseline value is the value at the clinic visit minus the Baseline value. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline and at least one post-baseline measurement.|Baseline (pre-dose at Day 1) and Week 24|ITT Population. Only those participants with data available at the specified data point were analyzed. Participants with a Baseline value and at least one post-baseline measurement were analyzed.|||Beats per minute||Standard Error|Least Squares Mean
2546381|NCT02924688|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24|Blood pressure (systolic and diastolic) was measured in the sitting position after approximately 5 minutes rest. Baseline value is the last acceptable/borderline acceptable value prior to randomized treatment start date (pre-dose at Day 1). Change from Baseline value is the value at the clinic visit minus the Baseline value. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline and at least one post-baseline measurement.|Baseline (pre-dose at Day 1) and Week 24|ITT Population. Only those participants with data available at the specified data point were analyzed. Participants with a Baseline value and at least one post-baseline measurement were analyzed.|||Millimeter of mercury||Standard Error|Least Squares Mean
2546382|NCT02924688|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Twelve-lead ECGs were performed during the study using an automated ECG machine. All ECG measurements were made with the participant in a supine position having rested in this position for approximately 5 minutes before each reading. The number of participants with worst case post-Baseline abnormal ECG findings were reported.|Up to Week 52|ITT Population. Only those participants with data available at the specified time point were analyzed.|||Participants|||Count of Participants
2546383|NCT02924688|Secondary|Number of Participants With Any Serious Adverse Event (SAE) and Common (>=3%) Non-SAE|Adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, events associated with liver injury and impaired liver function, or any other situation according to medical or scientific judgment were categorized as SAE. Number of participants with any SAE and common (>=3%) non-SAEs are presented.|Up to Week 52|ITT Population|||Participants|||Count of Participants
2546384|NCT02924688|Secondary|Mean Change From Baseline in Evaluating Respiratory Symptoms (E-RS) Total Score Over Weeks 21 to 24 (Inclusive) of the Treatment Period|The E-RS in Chronic Obstructive Pulmonary Disease (COPD) consists of 11 items. E-RS captures information related to respiratory symptoms, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness. The E-RS was completed daily and data was derived by 4-weekly intervals, requiring at least 50% of data to be present during a period. 7 items are scored from 0 (not at all) to 4 (extreme) and 4 items are scored from 0 (not at all) to 3 (extreme). The E-RS total score was calculated by taking sum of all the items. The E-RS total score has a scoring range of 0 to 40, with higher scores indicating more severe respiratory symptoms. Treatment policy estimand was assessed, including all on- and post-treatment data. Baseline value was the mean value of 14 days prior to randomization. Change from Baseline was calculated as post-baseline value (mean of daily E-RS total scores during Week 21 to 24 ) minus Baseline value.|Baseline (14 days prior to randomization) and Weeks 21 to 24|ITT Population. Participants with a Baseline value and at least one post-baseline measurement were analyzed. Analysis used pooled data from two FF/UMEC/VI arms for each fixed UMEC dose compared to pooled data from two FF/VI arms to provide a more precise estimate for the treatment effect of the addition of UMEC to FF/VI.|||Scores on a scale||Standard Error|Least Squares Mean
2546385|NCT02924688|Secondary|Mean Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 24|The SGRQ had 50 questions (scored from 0 to 100 where 0 indicates best and 100 indicates worst health) designed to measure quality of life (QoL) of participants with airway obstruction, measuring symptoms, impact, and activity. The questions are designed to be self-completed by the participant with a recall over the past 3 months. SGRQ total score was calculated by summing the pre-assigned weights of answers, dividing by the sum of the maximum weights for items in SGRQ and multiplying by 100. SGRQ total score ranges from 0 to 100 where 0 indicates best and 100 indicates worst health. A change of 4 points is considered a clinically relevant change. Treatment policy estimand was assessed, including all on- and post-treatment data. Baseline value was at randomization visit (pre-dose at Day 1). Change from Baseline value is the value at Week 24 minus the Baseline value.|Baseline (pre-dose at Day 1) and Week 24|ITT Population. Participants with a Baseline value and at least one post-baseline measurement were analyzed. Analysis used pooled data from two FF/UMEC/VI arms for each fixed UMEC dose compared to pooled data from two FF/VI arms to provide a more precise estimate for the treatment effect of the addition of UMEC to FF/VI.|||Scores on a scale||Standard Error|Least Squares Mean
2546402|NCT02923830|Secondary|Number of Days Catheter Remains Patent (Unobstructed)|The number of days from study enrollment to the first partial or complete occlusion and the number of days between incidences of partial or complete occlusion will be recorded.|baseline to 1 year|Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.||||||
2546403|NCT02923830|Secondary|Number of Complete or Partial Occlusions|The number of complete or partial occlusions after the first occurrence will be recorded.|baseline to 1 year|Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.||||||
2546386|NCT02924688|Secondary|Mean Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) Total Score at Week 24|The ACQ-7 consists of 7 attributes of asthma control, of which 6 to be self-completed by participant in a 6-item questionnaire, enquire about frequency and/or severity of symptoms over the previous week on: nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath, wheeze, and rescue medication use. The seventh attribute measures the lung function, which was included via pre-bronchodilator FEV1 % predicted value. All 7 items of ACQ have response on 0-6 ordinal scale (0=no impairment/limitation, 6=total impairment/limitation). The total score is calculated as the average of all non-missing item responses, ranges from 0 to 6. Higher score indicates worst symptoms. Treatment policy estimand was assessed, including all on- and post-treatment data. Baseline value was at randomization visit (pre-dose,Day 1). Change from Baseline was defined as value at Week 24 minus Baseline value.|Baseline (pre-dose at Day 1) and Week 24|ITT Population. Participants with available data at Baseline and at least one time point post-baseline were analyzed. Analysis used pooled data from two FF/UMEC/VI arms for each fixed UMEC dose compared to pooled data from two FF/VI arms to provide a more precise estimate for the treatment effect of the addition of UMEC to FF/VI.|||Scores on a scale||Standard Error|Least Squares Mean
2546387|NCT02924688|Secondary|Mean Change From Baseline in Clinic FEV1 at 3 Hours Post Study Treatment at Week 24|FEV1 is a measure of lung function and is defined as the maximal volume of air that can be forcefully exhaled in one second. Baseline value is the last acceptable/borderline acceptable pre-dose FEV1 prior to randomized treatment start date (pre-dose at Day 1). Change from Baseline value is the value at Week 24 (recorded at 3 hours post dose) minus the Baseline value.|Baseline (pre-dose at Day 1) and 3 hours post dose at Week 24|ITT Population. Only those participants with available Baseline and on-treatment data at Week 24 were analyzed.|||Liters||Standard Error|Least Squares Mean
2546388|NCT02924688|Secondary|Annualized Rate of Moderate and Severe Asthma Exacerbations|A moderate asthma exacerbation is considered to be a deterioration in asthma symptoms or in lung function, or increased rescue bronchodilator use lasting for at least 2 days or more, but not be severe enough to warrant systemic corticosteroid use (or a doubling or more of the maintenance systemic corticosteroid dose, if applicable) for 3 days or more and/or hospitalization. It is an event that, when recognized, should result in a temporary change in treatment, to prevent it from becoming severe. A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets,suspension or injection), or an increase from a stable maintenance dose (For participants receiving maintenance systemic corticosteroids, at least double the maintenance systemic corticosteroid dose for at least 3 days is required), for at least 3 days or an inpatient hospitalization or emergency department visit because of asthma, requiring systemic corticosteroids.|Up to Week 52|ITT Population. Only participants with at least one day on study post-randomization were analyzed. Analysis used pooled data from two FF/UMEC/VI arms for each fixed UMEC dose compared to pooled data from two FF/VI arms to provide a more precise estimate for the treatment effect of the addition of UMEC to FF/VI.|||Exacerbations per year||95% Confidence Interval|Mean
2546389|NCT02924688|Primary|Mean Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24|FEV1 is a measure of lung function and is defined as the maximal volume of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the highest FEV1 value obtained prior to the morning dose of investigational product. Baseline value is the last acceptable/borderline acceptable pre-dose FEV1 prior to randomized treatment start date (pre-dose at Day 1). Change from Baseline value is the value at Week 24 minus the Baseline value. Intent-to-Treat (ITT) Population comprised of all randomized participants, excluding those who were randomized in error, who did not receive the study drug. Treatment policy estimand was assessed, including all on- and post-treatment data. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline and at least one post-baseline measurement. Mixed Model Repeated Measures(MMRM) was used.|Baseline (pre-dose at Day 1) and Week 24|ITT Population. Only those participants with data available at the specified data point were analyzed. Participants with Baseline value and at least one post-baseline measurement were analyzed.|||Liters||Standard Error|Least Squares Mean
2546390|NCT02924350|Secondary|Change From Baseline (Day 0 Pre-treatment) in Tactile Threshold on Day 0 (After 60 Seconds of Single Direct Application) and Day 3|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed the application of a known force to the dentin surface, starting at 10gram (g) and raised in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses were recorded as the tactile threshold. Higher tactile threshold means less sensitive tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|At Baseline (Day 0 pre-treatment), after 60 seconds of single direct application on Day 0 and Day 3|ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is from ITT population evaluated at specific time points for each treatment arms respectively.|||g||Standard Deviation|Mean
2546391|NCT02924350|Secondary|Change From Baseline (Day 0 Pre-treatment) in Schiff Sensitivity Score on Day 0 (After 60 Seconds of Single Direct Application)|The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale as follows: 0=Participant does not respond to air stimulation, 1=Participant responds to air stimulus but does not request discontinuation of stimulus, 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3=Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.|At Baseline (Day 0 pre-treatment) and after 60 seconds of single direct application on Day 0|ITT population, defined as all participants who were randomized, received study treatment at least once & provided at least one post-baseline(post treatment) assessment of efficacy. Number of participants analyzed is the ITT population evaluated at specific time points for each treatment arms respectively.|||score on a scale||Standard Deviation|Mean
2546474|NCT02921386|Primary|Area Under the Curve (AUC-am)|The 12 hours following morning dose area under the curve (AUC) will assessed for each sequence of breakfasts with varying fat content.|0, 1, 2, 3, 4, 6, 8, 12 hours post-dose||||ng*hr/dL||Geometric Coefficient of Variation|Geometric Mean
2546392|NCT02924350|Primary|Change From Baseline in Schiff Sensitivity Score on Day 3|The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale as follows: 0=Participant does not respond to air stimulation, 1=Participant responds to air stimulus but does not request discontinuation of stimulus, 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3=Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.|Baseline, Day 3|Intent to treat (ITT) population, defined as all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is from ITT population evaluated at specific time points for each treatment arms respectively.|||score on a scale||Standard Deviation|Mean
2546393|NCT02924051|Secondary|Frequency of Fast Food Consumption|"Fast food consumption was measured using a single item on the National Cancer Institute Diety History Questionaire (NCI DHQ II) How often did you eat beef hamburgers or cheeseburgers from a fast food or other restaurant? Responses are selected from 11 pre-determined options increasing in frequency from never to 2 or more times per day. Values range from 0 to 10; higher values indicate an increased frequency of fast food consumption."|Baseline and 12 months|Participants completing the NCI DHQ II question related fast food comsumpsion|||units on a scale||Standard Error|Mean
2546394|NCT02924051|Secondary|Average Saturated Fatty Acid Intake/Day|Using the NCI DHQ II, respondents' frequency of consumption of foods (i.e., meats and oils) and portion size, dietary saturated fat consumption was calculated as average grams/day. Higher grams/day reflect higher consumption of saturated fatty acids.|Baseline, 12 months|Number of participants completing the NCI DHQ II survey|||grams/day||Standard Deviation|Mean
2546395|NCT02924051|Primary|Change in BLOCK Fruit/Vegetable/Fiber Screener From Baseline at 12 Months|Block Fruit/Vegetable/Fiber Screener is a tool that ranks usual intake of fruit, vegetables, and fiber. Total fruit/vegetable/fiber score can range from 0-50 with higher numbers reflecting greater frequency of fruit, vegetable and fiber consumption.|Baseline, 12 months|Participants who completed the Block Screener at baseline and post-intervention (12 months)|||units on a scale||Full Range|Mean
2546396|NCT02923895|Secondary|Change From Baseline in Tactile Threshold After a Single Use|Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.|Baseline to 60 seconds post first treatment|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||g||Standard Deviation|Mean
2546397|NCT02923895|Secondary|Change From Baseline in Schiff Sensitivity Score After a Single Use|The examiner assessed the participant's response to an evaporative air stimulus for each of the two test tooth using the Schiff Sensitivity Scale which was scored as follows: 0 Participant does not respond to air stimulation, 1 Participant responds to air stimulus but does not request discontinuation of stimulus, 2 Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3 Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. The Schiff sensitivity score was calculated as the average of individual test teeth score. Change from baseline in Schiff sensitivity was calculated as participant level mean change from baseline of the 2 test teeth. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline to 60 seconds post first treatment|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||Score on a scale||Standard Deviation|Mean
2546398|NCT02923895|Secondary|Change From Baseline in Tactile Threshold on Day 3|Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 gram[g] to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.|Baseline and Day 3|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||g||Standard Deviation|Mean
2546399|NCT02923895|Primary|Change From Baseline in Schiff Sensitivity Score on Day 3|The examiner assessed the participant's response to an evaporative air stimulus for each of the two test tooth using the Schiff Sensitivity Scale which was scored as follows: 0 Participant does not respond to air stimulation, 1 Participant responds to air stimulus but does not request discontinuation of stimulus, 2 Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3 Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. The Schiff sensitivity score was calculated as the average of individual test teeth score. Change from baseline in Schiff sensitivity was calculated as participant level mean change from baseline of the 2 test teeth. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline and Day 3|Analysis for this outcome was performed on Intent-to-treat (ITT) population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||Score on a scale||Standard Deviation|Mean
2546400|NCT02923830|Secondary|Heparin-related Complication|Heparin Induced Thrombocytopenia (HIT) as measured by a positive HIT antibody test, or any other heparin allergy, will be recorded.|baseline to 1 year|Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.||||||
2546475|NCT02921386|Primary|Time of Peak Concentration (Tmax-am)|The time of peak concentration (Tmax-am) will be assessed within each relevant dosing interval.|12 hours||||hours||Full Range|Median
2546404|NCT02923830|Primary|Number of Participants Who Required CathFlo (Alteplase) to Resolve an Occlusion|Number of Participants who required CathFlo (alteplase) to resolve an Occlusion over the 1 year. The date of first CathFlo administration will be recorded.|baseline to 1 year|Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.||||||
2546405|NCT02923830|Primary|Number of Participants With Occurrence of First Partial Occlusion (Blockage)|Number of Participants with Occurrence of First Partial Occlusion (Blockage) within the 1 year. The date of the first partial occlusion will be recorded.|baseline to 1 year|Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.||||||
2546406|NCT02923830|Primary|Number of Participants With Occurrence of First Complete Occlusion (Blockage)|Number of Participants with Occurrence of First Complete Occlusion (Blockage) over the 1 year. The date of the first complete occlusion will be recorded.|baseline to 1 year|Study was closed before enrolled subjects completed 12 months of data collection. Data were not analyzed.||||||
2546407|NCT02923271|Secondary|Change in the Number of Minutes of Phone Use Per Hour of Driving|Change in the number of minutes of phone use per hour of driving between baseline and the end of the intervention|8 weeks||||Change in the number of minutes of phone||Standard Deviation|Mean
2546408|NCT02923271|Primary|Change in Number of Cellphone Unlocks Per Hour of Drive Time|Change in number of cellphone unlocks per hour of drive time between baseline and the end of the intervention period|8 weeks||||Cell phone unlocks per hour||Standard Deviation|Mean
2546409|NCT02923245|Other Pre-specified|Inter-rater Agreement|Agreement between the POCUS sonographer and the blinded reviewer|at close of study|304 images were available for assessment of inter-rater reliability|||weighted kappa||95% Confidence Interval|Number
2546410|NCT02923245|Other Pre-specified|Disposition From ED||day of enrollment||||Participants|||Count of Participants
2546411|NCT02923245|Other Pre-specified|TAPUS Result||day of enrollment||||Participants|||Count of Participants
2546412|NCT02923245|Other Pre-specified|Total IV Fluids Given Prior to TAPUS||day of enrollment||||ml/Kg||Standard Deviation|Mean
2546413|NCT02923245|Other Pre-specified|Number of Participants Receiving IV Narcotics in the Emergency Department||day of enrollment||||Participants|||Count of Participants
2546414|NCT02923245|Secondary|Number of Participants Who Had a Successful Transabdominal Pelvic Ultrasound (TAPUS) on First Attempt||on same day as study enrollment||||Participants|||Count of Participants
2546415|NCT02923245|Primary|Median Fill-To-Done (FTD) Time|Median time from enrollment to successful completion of TAPUS|on same day as study enrollment||||minutes||Inter-Quartile Range|Median
2546416|NCT02922985|Secondary|Need for Respiratory Support|neonate receipt of oxygen by nasal cannula or mechanical ventilation|after birth and before hospital discharge||||Participants|||Count of Participants
2546417|NCT02922985|Secondary|NICU Admission|Rate of admission to the neonatal intensive care unit|after birth and before hospital discharge||||Participants|||Count of Participants
2546418|NCT02922985|Secondary|Apgar Score at 5 Minutes|This is the Apgar score of the newborn collected at 5 minutes. Range is from 0-10, with the higher scores meaning a better outcome.|5 minutes after birth||||score on a scale||Inter-Quartile Range|Median
2546419|NCT02922985|Secondary|Pain Score at 48 Hours Post-operatively|Pain Score at 48 Hours Post-operatively, expressed on a pain scale from 0-10 with the higher score meaning worse pain (outcome).|48 hours post-operatively||||score on a scale||Inter-Quartile Range|Median
2546420|NCT02922985|Secondary|Pain Score at 24 Hours Post-operatively|Pain Score at 24 Hours Post Operatively, expressed on a pain scale from 0-10 with the higher score meaning worse pain (outcome).|24 hours post-operatively||||score on a scale||Inter-Quartile Range|Median
2546421|NCT02922985|Secondary|Hospital Length of Stay|Time to discharge from hospital, measured in hours|From time of hospital admission to time of discharge home up to 100 days||||hours||Inter-Quartile Range|Median
2546422|NCT02922985|Secondary|Number of Opioid Pain Tablets Remaining on Post-operative Day #7 From the Discharge Prescription.|Number of opioid pain tablets remaining on post-operative day #7 from hospital discharge as reported by patients|7 days post delivery|We could not get the outcome on two patients from placebo control group and three patients from multimodal pain regimen group due to patients not responding to calls. These 5 five subjects were considered lost to follow up for this outcome.|||Tablets||Inter-Quartile Range|Median
2546423|NCT02922985|Secondary|Pain Score at 6-12 Hours Post Operatively|Pain score at 6-12 hours post-operatively, expressed on a pain scale from 0-10 with the higher score meaning worse pain (outcome).|6-12 hours post-operatively||||score on a scale||Inter-Quartile Range|Median
2546424|NCT02922985|Secondary|Time to First Administration of Opioid Pain Medication Post Operatively|Time, in hours, to first administration of opioid pain medication post operatively|48 hours post cesarean delivery||||hours||Inter-Quartile Range|Median
2546425|NCT02922985|Primary|Total Opioid Intake in Morphine Milligram Equivalents in the First 48 Hours After Cesarean Delivery (CD)|Every opioid intake by the patient in the first 48 hours after CD will be recorded and quantified in morphine milligram equivalents|48 hours post cesarean delivery||||morphine milligram equivalents||Inter-Quartile Range|Median
2546426|NCT02922868|Secondary|Number of Procedures Per Day Per Scope.|Number of procedures per day per scope. On a daily basis urology outpatient clinic performs an average of 5 cystoscopies.|Per day.||||Number of procedures per day per scope||Standard Deviation|Mean
2546427|NCT02922868|Secondary|Total Cost of Cystoscopy Reprocessing|The health economics of reprocessing will be evaluated by associating personnel hourly costs with cystoscope reprocessing time segments. The total cost was averaged between pre-cleaning, cleaning, disinfection, rinsing, and drying for the 30 cystoscopes in each group for a duration of 6 months.|6 months||||Dollars|||Number
2546428|NCT02922868|Secondary|Staff Assessment of Cystoscope Reprocessing.|At the end of each day while the study is in progress, 6 members of the medical staff directly involved with the reprocessing of cystoscopes will evaluate the ease of reprocessing based on a 5-point Likert scale for the following parameters: ease of Insertion, ease of manipulation, optical quality, overall ease of use. The score range is 0 to 5. Higher score denotes better outcomes. A single value was derived per staff member and summarized for the group as a whole during 6 months.|At the end of day of each procedure during 6 months||||units on a scale||Standard Error|Mean
2546429|NCT02922868|Secondary|Subject Assessment of Procedure.|After undergoing cystoscopy, patients will be asked to complete Visual Analog Scales (VAS) instruments to determine their level of pain experienced during cystoscopy as well as their perception of discomfort with the procedure. The score range is 0 to 100. Higher scores denotes worse outcomes.|Approximately 2 min after the end of procedure.||||units on a scale||Standard Error|Mean
2546430|NCT02922868|Secondary|Total Time to Reprocess a Cystoscope|The total time required for a cystoscope to be reprocessed so that it is available for re-use in a subsequent procedure will be measured.|Beginning from the time a cystoscope is withdrawn from the urethral meatus at the end of a procedure until the completion of reprocessing, approximately 3,869 seconds||||seconds||Standard Error|Mean
2546431|NCT02922868|Secondary|Number of Cystoscopes With Positive Bioburden Post-procedure.|Immediately after completion of each cystoscopy procedure, the bioburden on the cystoscopes will be evaluated. The flexible cystoscope sheath was removed for bioburden assessment. For each cystoscope, whether sheathed or standard, two locations were assessed - the control body and the shaft. Cultures were obtained wiping the entire surface with sterile saline pledgets. The sample pledgets were placed in 1 ml sterile saline and shaken for 30 seconds. Ten drops of 0.02 ml aliquots from the sample were spotted on two 5% blood agar plates and incubated at 35°C in CO2.|Immediately after cystoscopy.||||bioburdens|cystoscope locations||Number
2546432|NCT02922868|Primary|Number of Participants Who Had Post-Procedure Bacteriuria|The primary endpoint will be the change in bacteriuria pre- and post-procedure between EndoSheath CST-5000 cystoscope and standard (non-sheathed) Olympus Visera Elite OTV-S190 cystoscope during the course of routine clinical use in a urology clinic. The pre-procedure measurement of bacteriuria will occur on the day of the procedure. The post-procedure measurement of bacteriuria will occur approximately two weeks (10-14 days) post-procedure. This will be assessed by urine culture exams.|10-14 Days Post Procedure||||Participants|||Count of Participants
2546433|NCT02922738|Primary|Number of Follow-Up Visits to Any Provider for the Same Problem|Follow-up visits count is assessed at each phone interview. Patients report return visits.|Period of Assessment is up to 90 days after index visit||||Return Appointments||Full Range|Median
2546434|NCT02922738|Primary|Number of Patients With Resolved Skin Problems|"Resolved skin disease status was assessed by phone interview. Patient reported status. Patients were censored if unresolved at 90 days."|Period of assessment was up to 3 months (90 days) after index visit.|Number of patient participants only (excludes providers)|||Participants|||Count of Participants
2546435|NCT02921841|Secondary|Affect Dysregulation Scale|"A six-item scale assessing adolescents' perceived abilities to manage emotional upset (e.g., In the past three months, I have had trouble controlling my feelings.) in sexual situations. Scores range from 6 to 24 with higher scores indicated poorer perceived ability to manage emotional upset in sexual situations."|3 months post-intervention (average 6 months)|Missing data accounts for the discrepancy in the analytic sample for this measure.|||score on a scale||Standard Deviation|Mean
2546436|NCT02921841|Primary|Frequency of Recent Marijuana Use|Number of days marijuana was used in the past 30 days|3-months post-intervention|Restricted to those that indicated marijuana use in the past 30 days at the 3-month post-intervention follow-up.|||days||Standard Deviation|Mean
2546437|NCT02921841|Primary|Recent Marijuana Use|Marijuana use in the past 30 days (yes/no)|3-months post-intervention|Missing data accounts for the discrepancy in analytic sample for this measure.|||Participants|||Count of Participants
2546438|NCT02921841|Primary|Quantity of Recent Alcohol Use|Number of drinks reported on days that a participant drank alcohol in the past 30 days|3-months post-intervention|Restricted to those that indicated alcohol use in the past 30 days at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in the analytic sample for this measure.|||alcoholic drinks||Standard Deviation|Mean
2546439|NCT02921841|Primary|Frequency of Recent Alcohol Use|Number of days alcohol was used in the past 30 days|3-months post-intervention|Restricted to those that indicated alcohol use in the past 30 days at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in the analytic sample for this measure.|||days||Standard Deviation|Mean
2546440|NCT02921841|Primary|Recent Alcohol Use|Alcohol use in the past 30 days (yes/no)|3-months post-intervention||||Participants|||Count of Participants
2546441|NCT02921841|Primary|Condom Use Intention|"On a scale of 0 to 100, participants report how likely it is that they will use a condom when they have sex in the next 3 months. Zero represented I will not use a condom, 50 represented I will use a condom half the time., and 100 represented I will use a condom all the time.."|3-months post-intervention|Missing data accounts for the discrepancy in the analytic sample for this measure.|||units on a scale||Standard Deviation|Mean
2546442|NCT02921841|Primary|Frequency of Condom Use|Number of times a condom was used during oral, vaginal, and/or anal sex|3-months post-intervention|Restricted to those who were sexually active in the past three months at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in the analytic sample for this measure.|||times a condom was used||Standard Deviation|Mean
2546443|NCT02921841|Primary|Number of Sexual Partners|Number of sexual partners in the past 3 months.|3-months post-intervention|Restricted to those that were sexually active in the past 3 months at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in the analytic sample for this measure.|||sexual partners||Standard Deviation|Mean
2546444|NCT02921841|Primary|Frequency of Sexual Intercourse|Number of oral, vaginal, and/or anal sexual occurrences in the past 3 months.|3-months post-intervention|Restricted to those that were sexually active in the past 3 months at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in analytic sample for this measure.|||sexual acts||Standard Deviation|Mean
2546445|NCT02921841|Primary|Recent Oral, Vaginal, and/or Anal Sex|Oral, vaginal, and/or anal sex in the past 3 months|3-months post-intervention|Missing data accounts for the discrepancies in the analytic sample for this measure.|||Participants|||Count of Participants
2546446|NCT02921841|Primary|Lifetime Sexual Intercourse|Lifetime oral, vaginal, and/or anal sex|3-months post-intervention||||Participants|||Count of Participants
2546447|NCT02921841|Primary|Self-efficacy for HIV Prevention|"The scale contains 13 items that reflect the context of condom use, such as could use a condom when I'm very upset. Scores range from 13 to 52 with higher scores indicated lower self-efficacy for HIV prevention."|3 months post-intervention|Missing data accounts for the discrepancy in the analytic sample for this measure.|||score on a scale||Standard Deviation|Mean
2546448|NCT02921841|Primary|HIV Knowledge|HIV Knowledge Questionnaire. A 18-item (true, false, uncertain) scale surveys routes of transmission, casual contact misconceptions, general information and course of illness. Scores range from 0-18 with higher scores indicating greater HIV knowledge.|3 months post-intervention|Missing data accounts for the discrepancy in the analytic sample for this measure.|||score on a scale||Standard Deviation|Mean
2546449|NCT02921490|Primary|Facet Joint Any Grade MRI Signal Change Potential Effect on Management|Number/percentage of subjects for whom any grade MRI facet joint signal change would change clinical management|2 years||||Participants|||Count of Participants
2546450|NCT02921490|Primary|Facet Joint High Grade MRI Signal Change Potential Effect on Management|Number/percentage of subjects for whom high grade MRI facet joint signal change would change clinical management|2 years||||Participants|||Count of Participants
2546451|NCT02921490|Primary|Facet Joint All Grades of FDG Activity Potential Effect on Management|Number/percentage of subjects for whom any grade FDG scores would change clinical management|2 years||||Participants|||Count of Participants
2546452|NCT02921490|Primary|Facet Joint High Grade FDG Activity Potential Effect on Management|Number/percentage of subjects for whom high grade FDG scores would change clinical management|2 years||||Participants|||Count of Participants
2546453|NCT02921490|Primary|Facet Joint Any Grade of MRI Signal Change Concordance to Pain|Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression|2 years|two sides for each patient, for a total of 20 sides|||sides (Left or Right)|||Number
2546454|NCT02921490|Primary|Facet Joint High Grade MRI Signal Change Concordance to Pain|Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression|2 years|Two sides for each patient, for a total of 20 sides|||sides (left or right)|||Number
2546455|NCT02921490|Primary|Facet Joint All Grades of FDG Activity Concordance to Pain|Number/percentage of subjects (reported in sides, with two sides (Left or Right) per patient) for whom any grade (any evidence of increased FDG activity) of FDG scores are in concordance with clinical impression|2 years|The measure is best reported in sides, which is 2 sides per patient. 10 patients with 20 sides.|||sides (left or right)|sides (left or right)||Number
2546456|NCT02921490|Primary|Facet Joint High Grade FDG Activity Concordance to Pain|Concordance of high grade FDG scores with clinical impression|2 years||||concordance correlation coefficient|||Number
2546457|NCT02921425|Secondary|Change in Patient Activation|A 22-item scale that captures various domains of patient activation; scale range: 0 - 100, higher scores indicate greater activation|baseline, 3 months||||units on a scale||Standard Deviation|Mean
2546458|NCT02921425|Secondary|Change in Intent to Adhere to Diet|A single 7-point item, ranging from 1-7. Lower scores indicate an increased intent to adhere to diet|baseline, 3 months||||units on a scale||Standard Deviation|Mean
2546459|NCT02921425|Secondary|Change in Intent to Perform Physical Activity|A single 7-point item, ranging from 1 - 7, with lower values indicating increased intent to perform physical activity|baseline, 3 months||||units on a scale||Standard Deviation|Mean
2546460|NCT02921425|Secondary|Change From Baseline Diet Self-efficacy|a single 7-point item questionnaire (confidence in one's ability to adhere to a healthy diet). Scale range: 1 - 7. Higher numbers indicate less self-efficacy.|baseline, 3 months||||units on a scale||Standard Deviation|Mean
2546461|NCT02921425|Secondary|Change From Baseline Physical Activity Self-efficacy|"an 18-item exercise self-efficacy questionnaire (confidence in one's ability to exercise) exercises); scale range: 0 - 100.~Higher scores indicate increased self-efficacy."|baseline, 3 months||||units on a scale||Standard Deviation|Mean
2546462|NCT02921425|Primary|Systolic and Diastolic Blood Pressure||baseline, 3 months||||mmHg||Standard Deviation|Mean
2546463|NCT02921425|Primary|Change From Baseline Dietary Intake|24-hour dietary recall; the Nutrition Data System for Research used to compute kcal|baseline, 3 months||||kcal||Standard Deviation|Mean
2546464|NCT02921425|Primary|Change From Baseline Energy Expenditure|measured in kcal using an accelerometer|baseline, 3 months||||kcal||Standard Deviation|Mean
2546465|NCT02921425|Primary|Change From Baseline Abdominal Circumference|measured in inches|baseline, 3 months||||inches||Standard Deviation|Mean
2546466|NCT02921425|Primary|Body Mass Index|Measured in kg/m^2|baseline, 3 months||||kg/m^2||Standard Deviation|Mean
2546467|NCT02921425|Primary|Change From Baseline Weight|measured in lbs.|Baseline, 3 months||||lbs.||Standard Deviation|Mean
2546468|NCT02921412|Primary|Fit Acceptability|Investigator fit acceptability for each lens pair. Scale 0-4: (0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)|baseline, 2 weeks, 1 month|Analysis was performed prior to one participant completing the 2 week and 1 month visits.|||units on a scale||Standard Deviation|Mean
2546469|NCT02921412|Primary|Post-blink Movement|Post-blink lens movement assessed using the following evaluations (0-4): 0=Insufficient, unacceptable, 1=Minimal, acceptable, 2=Optimal, 3=Moderate, acceptable, 4=Excessive, unacceptable)|baseline, 2 weeks, 1 month|Analysis was performed prior to one participant completing the 2 week and 1 month visits.|||units on a scale||Standard Deviation|Mean
2546470|NCT02921412|Primary|Corneal Coverage|Corneal coverage will be assessed (yes/no)|baseline, 2 weeks, 1 month|Analysis was performed prior to one participant completing the 2 week and 1 month visits.|||Participants|||Count of Participants
2546471|NCT02921412|Primary|Centration|Lens centration is assessed (optimum, decentration acceptable, decentration unacceptable).|baseline, 2 weeks, 1 month|Analysis was performed prior to one participant completing the 2 week and 1 month visits.|||Participants|||Count of Participants
2546472|NCT02921412|Primary|Visual Acuity|High contrast distance visual acuity is measured by LogMAR.|baseline, 2 weeks, 1 month|Analysis was performed prior to one participant completing the 2 week and 1 month visits.|||logMAR||Standard Deviation|Mean
2546473|NCT02921386|Primary|Time Weighted Average Total Testosterone Concentration (Cavg-am)|The time weighted average of total testosterone concentration will be assessed for each dosing interval.|12 hours||||ng/dL||Geometric Coefficient of Variation|Geometric Mean
2546547|NCT02919995|Secondary|Vital Signs 1|Pulse rate after 5 minutes supine|Over 8 hours after treatment|||||||
2546476|NCT02921386|Primary|Cmax-am for Oral TU Across Breakfast With Varying Fat Content|Peak Concentration after morning dose (Cmax) for oral testosterone undecanoate taken after a fasting breakfast of varying fat content.|0, 1, 2, 3, 4, 6, 8, 12 hours post-dose||||ng/dL||Geometric Coefficient of Variation|Geometric Mean
2546477|NCT02921295|Secondary|Gait Symmetry Index|Left/Right Step Duration Ratio. Perfect gait symmetry would result in a ratio of 1.000. Any deviation would indicate that step lengths differ between legs, indicating a more or less pronounced limping. The measure is computed from the intermediary step sample of gait with each intervention. This allows averaging to reduce the risk of random errors in assessment. Step samples were extracted from walking trial data with the stubbies and with the sidekicks. Each walking trial contains more than 30 individual steps for analysis.|2 times throughout study completion (every 1 hour during the 2 hour protocol)||||ratio||Standard Deviation|Mean
2546478|NCT02921295|Secondary|Timed up and go Test Time|The test, as described in the protocol form, is performed three times with each intervention. This allows averaging to reduce the risk of random errors in timing the exercise. Accordingly, the participant is asked to repeat (with resting breaks in between) the tests three times with the stubbies and three times with the sidekicks.|6 times throughout study completion (3 every 1 hour during the 2 hour protocol)||||s||Standard Deviation|Mean
2546479|NCT02921295|Primary|Average Speed for 10 Meter Walk Test|The participant is timed while covering a 10-m distance unassisted (running start). The average speed is then calculated for each pass (one with each set of prosthetic feet), using the equation 10m/(recorded time in seconds). The average speed is computed as it is more reliable and representative than the instantaneous gait speed that may not be consistently maintained during the 10-m walk.|2 times throughout study completion (every 1 hour during the 2 hour protocol)||||m/s|||Number
2546480|NCT02921087|Post-Hoc|Phoria and Lens Preference|Subjects' phoria at near with single vision lenses was classified as esophoric or exophoric. Lens preference was compared (multifocal vs single vision lenses) between the subjects who were esophoric at near vs the subjects who were exophoric/orthophoric at near.|1 week|Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Of the 22 completed subjects, 5 had an esophoria at near. 17 were exophoric or orthophoric at near.|||Participants|||Count of Participants
2546481|NCT02921087|Post-Hoc|Participants Stratified by Subjects' Near Phoria With Single Vision Lenses||1 week|Phoria at near as measured through the single vision spherical contact lenses|||Participants|||Count of Participants
2546482|NCT02921087|Secondary|Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens|Measured via Modified Thorington|1 week|Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.|||Prism Diopters of Exophoria||Standard Deviation|Mean
2546483|NCT02921087|Secondary|Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8)|CLDEQ-8 score after one week of multifocal contact lenses vs single vision contact lenses. Minimum value (least symptoms) = 0. Maximum Score= 37 (worst symptoms).|1 week|Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.|||score on a scale||Standard Deviation|Mean
2546484|NCT02921087|Secondary|Convergence Insufficiency Symptom Survey (CISS)|Difference in CISS score after one week of multifocal contact lens use vs single vision contact lens use. Minimum score (least symptoms)= 0. Maximum score (worst symptoms) = 60.|1 week|Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.|||score on a scale||Standard Deviation|Mean
2546485|NCT02921087|Secondary|Lag of Accommodation in Study Lenses|Accommodative response was measured by having subjects switch the right lens to a spherical lens in the appropriate power. This was done for all subjects regardless of which lens they were randomized to, to maintain masking. Subjects wore an infrared filter over the right eye for occlusion and to ensure that they were fixating with the left eye (which was still wearing the lens they were randomized to). This filter allowed for measurements to be taken with the WAM-5500 open field autorefractor in front of the right eye. This method assumes a symmetrical accommodative response between eyes. Since accommodative response was measured monocularly, this eliminated any convergent accommodation, but this was consistent between lenses and test distances. Five measurements were taken at each test distance (distance, 40cm and 25cm). The 5 readings obtained were used to calculate mean spherical equivalent value at each test distance and compared to expected accommodative value to determine lag.|1 week|Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.|||Diopters||Standard Deviation|Mean
2546486|NCT02921087|Secondary|Lens Preference|Based on two alternative forced choice method|2 weeks|Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.|||Participants|||Count of Participants
2546487|NCT02921087|Primary|Subjective Symptom Improvement|The primary outcome measure was change in average score on a ten question Visual Comfort Survey using a Visual Analogue Scale (VAS) from baseline to day 7 in multifocal contact lenses and single vision contact lenses. The Visual Analogue Scale ranges from 0-100 (100 being the worst symptoms) for each of the ten questions. The maximum total score is 1000, the minimum total score is 0 (no symptoms).|Baseline and after 1 week of wearing each lens.|Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. One week data for the primary outcome was available for 22 subjects.|||score on a scale||Standard Deviation|Mean
2546488|NCT02921061|Secondary|Number of Participants With Event-free Survival||Up to 1 year||||participants|||Number
2546489|NCT02921061|Secondary|Number of Participants With Relapse-free Survival||Up to 1 year||||participants|||Number
2546490|NCT02921061|Secondary|Number of Participants With Overall Survival||Up to 1 year||||participants|||Number
2546491|NCT02921061|Secondary|Number of Participants Who Achieved Remission (Complete Remission [CR]/CR With Incomplete Peripheral Blood Count Recovery [CRi])||Up to 1 year||||participants|||Number
2546492|NCT02921061|Secondary|Number of Participants With Minimal Residual Disease Negative (MRDneg) Complete Remission (Phase II)|Compared to historical controls of filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride (G-CLAM) alone. A Simon Minimax two-stage design will be used.|Up to 1 year||||participants|||Number
2546493|NCT02921061|Primary|Number of Participants Experiencing Dose Limiting Toxicities (DLTs) at the Maximum Tolerated Dose (MTD) for Decitabine When Given Together With G-CLAM Toxicities (DLTs) (Phase I)|"Evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. MTD is defined as the highest dose studied in which the incidence of DLT is < 33%. Each participant was monitored for DLTs in the first 20 days of treatment. DLTs monitored included~any grade 3 non-hematologic toxicity lasting more than 48 hours that resulted in more than a 7 day delay of the subsequent treatment cycle (except for febrile neutropenia or infection)~any grade 4 or greater non-hematologic toxicity (except febrile neutropenia and infection unless a direct consequence of a treatment-related toxicity, and except constitutional symptoms if they recovered to grade 2 or less within 14 days)~lack of recovery of the absolute neutrophil count to 500/microliter or greater and lack of self-sustained platelet count of at least 50,000/microliter by treatment day +49 with no evidence of residual leukemia"|Up to 49 days||||Participants|||Count of Participants
2546494|NCT02920983|Secondary|Visual Acuity|Visual acuity will be assessed by LogMAR.|1 week|Protocol deviations and discontinuations account for difference in analysis population|||LogMAR||Standard Deviation|Mean
2546495|NCT02920983|Secondary|Lens Surface - Wettability|Lens wettability will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|1 week|Protocol deviations and discontinuations account for difference in analysis population|||Participants|||Count of Participants
2546496|NCT02920983|Secondary|Lens Surface - Deposition|Lens surface will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|1 week|Protocol deviations and discontinuations account for difference in analysis population|||Participants|||Count of Participants
2546497|NCT02920983|Secondary|Lens Fit - Movement|Lens movement assessed using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.|1 week|Protocol deviations and discontinuations account for difference in analysis population|||Participants|||Count of Participants
2546498|NCT02920983|Secondary|Lens Fit - Corneal Coverage|Corneal coverage will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.|1 week|Protocol deviations and discontinuations account for difference in analysis population|||Participants|||Count of Participants
2546499|NCT02920983|Secondary|Lens Fit - Vertical Centration|Vertical centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.|1 week|Protocol deviations and discontinuations account for difference in analysis population|||Participants|||Count of Participants
2546500|NCT02920983|Secondary|Lens Fit - Horizontal Centration|Horizontal centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.|1 week|Protocol deviations and discontinuations account for difference in analysis population|||Participants|||Count of Participants
2546501|NCT02920983|Primary|Ocular Physiology|Ocular physiology assessment of by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).|1 week|Protocol deviations and discontinuations account for difference in analysis population|||units on a scale||Standard Deviation|Mean
2546502|NCT02920970|Primary|Lens Movement|Lens movement assessed for narafilcon A and senofilcon A lenses and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.|1 week|There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations|||Participants|||Count of Participants
2546503|NCT02920970|Primary|Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses|Corneal coverage will be assessed for narafilcon A and stenfilcon A and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.|1 week|There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations|||Participants|||Count of Participants
2546504|NCT02920970|Primary|Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses|Vertical centration assessed for narafilcon A and stenfilcon A lenses and graded as extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.|1 week|There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations|||Participants|||Count of Participants
2546505|NCT02920970|Primary|Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses|Horizontal centration assessed for narafilcon A and stenfilcon A lenses categorized as extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.|1 week|There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations|||Participants|||Count of Participants
2546506|NCT02920970|Primary|Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses|Lens wettability for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)|1 week|There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations|||Participants|||Count of Participants
2546507|NCT02920970|Primary|Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses|Lens surface for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)|1 week|There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations|||Participants|||Count of Participants
2546508|NCT02920970|Primary|Vision of Stenfilcon A and Narafilcon A Lenses|Subjective responses for vision will be evaluated for each pair using questionnaire (Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent).|1 week|There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations|||units on a scale||Standard Deviation|Mean
2546509|NCT02920970|Primary|Dryness of Stenfilcon A and Narafilcon A Lenses|Subjective responses for dryness will be evaluated for each pair using questionnaire (Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness).|1 week|There were 2 participants excluded from the analysis for narafilcon A due to protocol deviations|||units on a scale||Standard Deviation|Mean
2546548|NCT02919995|Secondary|Laboratory Safety Tests 3|Urinalysis measured by urine dipstick|Screening and end of study|||||||
2546549|NCT02919995|Secondary|Laboratory Safety Tests 2|Haematology panel parameters|Screening and end of study|||||||
2546510|NCT02920970|Primary|Comfort Level of Stenfilcon A and Narafilcon A Lenses|Subjective responses for overall comfort will be evaluated for each pair using questionnaire (Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).|1 week|There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations|||units on a scale||Standard Deviation|Mean
2546511|NCT02920970|Primary|Visual Acuity|Visual acuity for narafilcon A and stenfilcon A are assessed by LogMAR. High contrast is measured with black letters on a white background. Low contrast is measured with gray letters on a white background.|1 week|There were 2 participants excluded from the analysis for narafilcon A at follow up due to protocol deviations.|||LogMAR||Standard Deviation|Mean
2546512|NCT02920970|Primary|Ocular Physiology|Ocular physiology assessment of narafilcon A and stenfilcon A lenses by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).|1 week|There were 2 participants excluded from the analysis for narafilcon A due to protocol deviations|||units on a scale||Standard Deviation|Mean
2546513|NCT02920957|Primary|Deposit Grading|Deposit grading for comfilcon A and senofilcon C lenses. Scale 0-4 (0.5 step size) (0=no deposits, 4=severe deposits)|Up to 1 month|Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.|||units on a scale||Standard Deviation|Mean
2546514|NCT02920957|Primary|Lens Wettability|Lens wettability for comfilcon A and senofilcon C lenses. Scale 0-4, (0.5 step size) (0=very poor, 4=excellent)|Up to 1 month|Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.|||units on a scale||Standard Deviation|Mean
2546515|NCT02920957|Primary|Tightness on Push up|Tightness on push up for comfilcon A and senofilcon C lenses. Scale 0%-100%, 0%=falls from cornea, 50%=optimum, 100%=no movement)|Up to 1 month|Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.|||units on a scale||Standard Deviation|Mean
2546516|NCT02920957|Primary|Lens Lag at Primary Gaze|Lens lag at primary gaze for comfilcon A and senofilcon C lenses. (mm, 0.1 step size)|Up to 1 month|Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.|||millimeters||Standard Deviation|Mean
2546517|NCT02920957|Primary|Post-blink Movement|Post-blink movement for comfilcon A and senofilcon C lenses. Scale 0-4, (1 step size) (0=Insufficient, 4=Excessive, unacceptable movement)|Up to 1 month|Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.|||units on a scale||Standard Deviation|Mean
2546518|NCT02920957|Primary|Lens Centration|Lens centration for comfilcon A and senofilcon C lenses. (optimum/ decentration acceptable/ decentration unacceptable)|Up to 1 month|Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.|||participants|||Number
2546519|NCT02920957|Primary|Corneal Coverage|Corneal coverage for comfilcon A and senofilcon C lenses. (yes/no)|Up to 1 month|Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.|||participants|||Number
2546520|NCT02920957|Primary|Overall Lens Fit Acceptance|Investigator fit acceptability for comfilcon A and senofilcon C lenses. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect.|Up to 1 month|Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.|||units on a scale||Standard Deviation|Mean
2546521|NCT02920918|Primary|Change From Baseline Ventilatory Efficiency at 12 Weeks|Minute ventilation (VE) relative to CO2 production (VCO2) slope measured by cardiopulmonary exercise test|baseline and 12 weeks|Unadjusted p values were reported throughout, with statistical significance set at the 2-tailed 0.05 level. Only cases with available data used to compute the primary endpoint will be included in the analyses (16 subjects for canagliflozin group and 18 subjects for sitagliptin group).|||Unitless||Standard Deviation|Mean
2546522|NCT02920918|Primary|Change From Baseline Aerobic Exercise Capacity at 12 Weeks|Peak oxygen consumption (VO2) measured by maximal cardiopulmonary exercise test|baseline and 12 weeks|Unadjusted p values were reported throughout, with statistical significance set at the 2-tailed 0.05 level. Only cases with available data used to compute the primary endpoint will be included in the analyses (16 subjects for canagliflozin group and 18 subjects for sitagliptin group).|||mL/kg/min||Standard Deviation|Mean
2546523|NCT02920749|Secondary|Costs of Anaesthesia|total cost of drugs (midazolam, propofol 1%, sevoflurane, atracurium, diclofenac, nalbuphin and antidotes) and disposable cost in euros|1 hour||||euros|total cost of anaesthesia|Standard Deviation|Mean
2546524|NCT02920749|Primary|Drug Consumption|drugs of sevoflurane or total intravenous anaesthesia without or with BIS and TOF monitoring : fentanyl, sevoflurane, propofol 1%, atracurium in milligrams|at induction one dose and during anaesthesia mg/1 hour||||mg||Standard Deviation|Mean
2546525|NCT02920476|Secondary|Overall Survival (OS)|To determine the overall survival in months|1 year||2020-06-30|06/2020||||
2546526|NCT02920476|Secondary|Clinical Benefit Rate|To determine the percentage of subjects who derive clinical benefit by RECIST 1.1 criteria. The clinical benefit rate is defined as the percentage of subjects who achieved either a complete or partial response or stable disease by RECIST 1.1 criteria. RECIST 1.1 criteria defines a partial response as a decrease of the sum of the largest diameter each target lesion by at least 30%. A complete response is defined as the disappearance of all target lesions (except lymph nodes, whose short axis must measure 10 mm or less). By RECIST 1.1 criteria, a subject is considered to have stable disease when the sum of the largest diameter of the target lesions has neither decreased enough to qualify as a partial response not increased enough to qualify as progressive disease.|1 year|Only 2 of the 4 participants accrued were evaluable for this outcome measure.|||Participants|||Count of Participants
2546527|NCT02920476|Primary|Objective Response Rate (ORR)|To determine the percentage of subjects who achieve an objective response by RECIST 1.1 criteria. ORR is defined as the number of participants who achieved either a partial or complete response by RECIST 1.1 criteria. By these criteria, Complete Response (CR) is defined as the disappearance of all target lesions and Partial Response (PR) is defined as a decrease of at least 30% in the sum of the longest diameter of the target lesions. Subjects must have received at least 2 cycles of therapy to be evaluable for this outcome measure.|1 year|Only 2 of the 4 subjects accrued to the study were evaluable for treatment response.|||Participants|||Count of Participants
2546550|NCT02919995|Secondary|Laboratory Safety Tests 1|Biochemistry panel parameters|Screening and end of study|||||||
2546528|NCT02920450|Primary|Objective Response Rate (ORR)|To estimate the objective rate of response of PF-05212384 in combination with paclitaxel and carboplatin administered to subjects with unresectable or metastatic NSCLC, according to current RECIST criteria. ORR is defined as the number of participants who achieved either a partial or complete response by RECIST 1.1 criteria. By these criteria, Complete Response (CR) is defined as the disappearance of all target lesions and Partial Response (PR) is defined as a decrease of at least 30% in the sum of the longest diameter of the target lesions.|1 year|The sample of only 1 evaluable subject was not sufficient to analyze this outcome measure.||||||
2546529|NCT02920450|Primary|Dose Tolerability|To identify the maximum tolerated dose of PF-05212384 in combination with paclitaxel and carboplatin in subjects with NSCLC.|1 year|Data are not reported for this outcome measure because an insufficient number of participants were evaluable to determine the MTD.||||||
2546530|NCT02920242|Secondary|Microbiological Cure Rate||study day 5|The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.||||||
2546531|NCT02920242|Secondary|The Presence or Absence and Severity of Signs and Symptoms of Enteric Infection||within 5 study days|The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.||||||
2546532|NCT02920242|Secondary|Number of Unformed Stools||within 5 study days|The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.||||||
2546533|NCT02920242|Secondary|Proportion of Patients With Improvement of Diarrheal Syndrome||within 5 study days|The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.||||||
2546534|NCT02920242|Secondary|Proportion of Patients With Clinical Failure||within 5 study days|The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.||||||
2546535|NCT02920242|Secondary|Time to Last Unformed Stool||within 5 study days|The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.||||||
2546536|NCT02920242|Primary|Clinical Cure Rate|Clinical cure was defined as either no stools or only formed stools within a 48 hour period and no fever, with or without other enteric symptoms, OR no watery stools or no more than two soft stools passed within a 24 hour period with no fever and no other enteric symptoms except for mild excess gas/flatulence.|study day 5 +/- 1 day|The study was terminated after only 28 patients (6% of planned population) were randomized. In line with the predefined Statistical Analysis Plan (SAP) no efficacy analysis was performed due to low sample size.||||||
2546537|NCT02920177|Secondary|Change in Kellgren-Lawrence Classification Scores|Calculated from anterior-posterior (AP) pelvis radiographs. Kellgren Lawrence grading system was intended to be utilized analyzing pre-treatment and post-treatment radiographs of the knee. Grading is from 1 to 4 with 1 being minimal to mild disease and 4 being end stage joint disease.|12 months|No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up.||||||
2546538|NCT02920177|Secondary|Serum Biomarker Analysis: IFN-g, IL-6, MCP-1, MIP-1b, IL-1b, TNF-alpha, Highly Sensitive CRP, COMP.||12 months|No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up.||||||
2546539|NCT02920177|Secondary|Patient Reported Outcome Measurement Information System (PROMIS) Global Health Scale|"Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. Global mental health scores range from 0 - 100, and higher scores indicate better mental health.~Global physical health measures overall physical health, physical function, pain and fatigue. Physical global health scores range from 0 - 100, and higher scores indicate better physical health."|12 months|No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up.||||||
2546540|NCT02920177|Secondary|Hip Disability and Osteoarthritis Outcome Score (HOOS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), Calculated as a Sub-score of the HOOS|"Measure Description: Hip Disability and Osteoarthritis Outcome Score (HOOS) is a hip-specific patient-reported outcome measure that has 5 subscales. Each subscale is score separately and ranges from 0-100, 100 = no disability, therefore higher values indicate a better outcome.~The WOMAC (Western Ontario and McMaster Universities) index is used to assess patients with osteoarthritis of the hip or knee and contains 24 questions, targeting areas of pain, stiffness and physical function. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). WOMAC total is the sum of the three components and it ranges from 0 to 96 points, being 96 the worst outcome.~The questions that are included in the WOMAC are a subgroup of questions that are included in the HOOS, so because of this the HOOS survey can also be used to calculate the WOMAC score for patients."|12 months|No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up.||||||
2546541|NCT02920177|Primary|Change From Baseline in Pain Score on the Visual Analog Scale|"VAS score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity."|12 months|No twelve month data was collected because none of the endpoints were reached. All participants left the study before the 6 month follow up.||||||
2546542|NCT02919995|Other Pre-specified|Sputum Measurements|Levels of inflammatory mediators|8 and 12 hours after treatment|||||||
2546543|NCT02919995|Other Pre-specified|Sputum Rheology|Rheological analysis for interleukin 8, tumour necrosis factor alpha and myeloperoxidase|8 and 12 hours after treatment|||||||
2546544|NCT02919995|Secondary|ECG 2|QT interval|Over 8 hours after treatment|||||||
2546545|NCT02919995|Secondary|ECG 1|Heart rate|Over 8 hours after treatment|||||||
2546546|NCT02919995|Secondary|Vital Signs 2|Blood pressure after 5 minutes supine|Over 8 hours after treatment|||||||
2546553|NCT02919995|Secondary|AUC FEV1(0-8h)|Area under the curve for FEV1 over 8 hours measured using spirometry|pre dose and 15 and 30 minutes and 1, 2, 4, 6 and 8 hours post dose|All randomised patients with sufficient data collected after intake of study treatment to compute the pharmacodynamic parameters on at least two study visits.|||Liters||Standard Deviation|Mean
2546554|NCT02919995|Secondary|AUC FEV1(0-6h)|Area under the curve FEV1 over 6 hours measured using spirometry|Pre dose and 15 and 30 minutes and 1, 2, 4 and 6 hours post dose|all randomized patients with sufficient data collected after intake of study treatment to compute the pharmacodynamic parameters on at least two study visits.|||Liters||Standard Deviation|Mean
2546555|NCT02919995|Secondary|AUC FEV1(0-4h)|Area under the curve for FEV1 over 4 hours measured using spirometry|Pre dose and 15 and 30 minutes and 1, 2 and 4 hours post dose|All randomized patients with sufficient data collected after intake of study treatment to compute the pharmacodynamic parameters on at least two study visits.|||Liters||Standard Deviation|Mean
2546556|NCT02919995|Secondary|Peak FEV1 for Each Treatment|Maximum Forced expired volume in one second (FEV1) measured using spirometry|Pre dose and 15 and 30 minutes and 1, 2 and 4 hours post dose after treatment|All randomized patients with sufficient data collected after intake of study treatment to compute the pharmacodynamic parameters on at least two study visits.|||Liters||Standard Deviation|Mean
2546557|NCT02919995|Primary|Half Life for Each Dose|Half life (t1/2) of RPL554|Pre dose, 15 and 30 minutes and 1, 2, 4, 6, 8 and 24 hours post dose|All randomised patients with blood sampling performed after at least one dose of RPL554 and with data sufficient to calculate pharmacokinetic parameters.|||Hours||Standard Deviation|Mean
2546558|NCT02919995|Primary|Time to Maximum Plasma Concentration After Each Dose|Time to maximum concentration (Tmax) after a single dose of RPL554|Pre dose, 15 and 30 minutes and 1, 2, 4, 6, 8 and 24 hours post dose|All randomised patients with blood sampling performed after at least one dose of RPL554 and with data sufficient to calculate pharmacokinetic parameters.|||hours||Standard Deviation|Mean
2546559|NCT02919995|Primary|Maximum Plasma Concentration After Each Dose|Maximum plasma concentration (Cmax) after a single dose of RPL554|Pre dose, 15 and 30 minutes and 1, 2, 4, 6, 8 and 24 hours post dose|All randomised patients with blood sampling performed after at least one dose of RPL554 and with data sufficient to calculate pharmacokinetic parameters.|||pg/mL||Standard Deviation|Mean
2546560|NCT02919995|Primary|AUC by Dose|Area under the curve (AUC)|Pre dose, 15 and 30 minutes and 1, 2, 4, 6, 8 and 24 hours post dose after each treatment|All randomised patients with blood sampling performed after at least one dose of RPL554 and with data sufficient to calculate pharmacokinetic parameters.|||pg*h/mL||Standard Deviation|Mean
2546561|NCT02919813|Secondary|Quality of Life Questionnaire Response|Perceived treatment improvement and satisfaction in quality of life questionnaire. Questionnaires for quality of life at end of group intervention and at 3 months and 6 months follow up.|Change from end of study until 6 months after study|Outcome was not analyzed.||||||
2546562|NCT02919813|Secondary|Pain Catastrophizing Scale Response|Change from baseline in pain catastrophizing at 6 months. Participants will complete the Pain Catastrophizing Scale survey. The survey consists of thirteen statements describing different thoughts and feelings that may be associated with pain. Total score = sum of 13 statement subscales; range 0 (better outcome) - 52 (worse outcome). The pain catastrophizing surveys will be completed at baseline and 6 months follow up. A negative change in score from baseline indicates less pain catastrophizing over time (better outcome) and a positive change in score from baseline indicates more pain catastrophizing over time (worse outcome).|Change from time of enrollment until 6 months after study||||score on a scale||95% Confidence Interval|Mean
2546563|NCT02919813|Secondary|Anxiety Questionnaire Response|Change from baseline in anxiety at 6 months. Participants will complete the General Anxiety Disorder-7 (GAD-7) scale questionnaire. The GAD-7 consists of 7 problems where participants rate how often they have been bothered by those problems during the past 2 weeks. Total score = sum of 7 subscales; range 0 (better outcome) - 21 (worse outcome). The GAD-7 surveys will be completed at baseline and 6 months follow up. A negative change in GAD-7 score from baseline indicates less anxiety over time (better outcome) and a positive change in GAD-7 score from baseline indicates more anxiety over time (worse outcome).|Change from time of enrollment until 6 months after study||||score on a scale||95% Confidence Interval|Mean
2546564|NCT02919813|Secondary|Depression Questionnaire Response|Change from baseline in depression at 6 months. Participants will complete the Beck Depression Inventory (BDI-PC) questionnaire, which consists of 21 groups of statements where participants selects which statement best describes how they have been feeling during the past 2 weeks. Total score = sum of 21 statement subscales; range 0 (better outcome) - 63 (worse outcome). The BDI-PC surveys will be completed at baseline and 6 months follow up. A negative change in BDI-PC score from baseline indicates less depression over time (better outcome) and a positive change in BDI-PC score from baseline indicates more depression over time (worse outcome).|Change from time of enrollment until 6 months after study||||score on a scale||95% Confidence Interval|Mean
2546565|NCT02919813|Secondary|Sexual Function Questionnaire Response|Change from baseline in sexual function at 6 months. Participants will complete a Female Sexual Function Index (FSFI) survey which asks questions about participants sexual feelings over the past 4 weeks; range 2 (worse outcome) - 95 (better outcome). The FSFI surveys will be completed at baseline and 6 months follow up. A negative change in FSFI score from baseline indicates less sexual function over time (worse outcome) and a positive change in FSFI score from baseline indicates more sexual function over time (better outcome).|Change from time of enrollment until 6 months after study||||score on a scale||95% Confidence Interval|Mean
2546566|NCT02919813|Secondary|Sexual Distress Survey Response|Change from baseline in sexual distress at 6 months. Participants will complete a Female Sexual Distress Scale (FSDS) survey to rate their feelings associated with sexual activities; range 0 (better outcome) - 52 (worse outcome). The FSDS surveys will be completed at baseline and 6 months follow up. A negative change in FSDS score from baseline indicates less sexual distress over time (better outcome) and a positive change in FSDS score from baseline indicates more sexual distress over time (worse outcome).|Change from time of enrollment until 6 months after study||||score on a scale||95% Confidence Interval|Mean
2546663|NCT02918357|Secondary|Inter-reader Agreement Per-region|Inter-reader reproducibility for positivity at region level was reported using the Fleiss' Kappa test for multiple readers. Kappa value varies from 0 (no agreement) to 1 (perfect agreement).|1 month|Patients included in the analyses were scanned to include all regions under review|||kappa||95% Confidence Interval|Number
2546567|NCT02919813|Primary|Tampon Test|The change from baseline in pain measured by the Tampon Test at 6 months. The tampon test is a validated tool used to measure (vulva) vestibular skin pain by having participants insert and remove a tampon. Participants will be asked to rate their pain along a 100 mm Visual Analog Scale on a scale of 0 (No pain) to 10 (Pain as bad as you can imagine). This test will occur at baseline and 6 months follow up.|Change from time of enrollment until 6 months after study||||units on a scale||95% Confidence Interval|Mean
2546568|NCT02919761|Secondary|Part 2: Physician's Global Assessment of Disease Activities by Visit|The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement.|Week 12 to Week 24|mITT Population|||mm||Standard Deviation|Mean
2546569|NCT02919761|Secondary|Part 1: Physician's Global Assessment of Disease Activities by Visit|The physician rates the participant's disease activity on a 100 mm visual analogue scale, where 0=very good and 100=very bad. Lower scores indicate improvement.|Baseline to Week 12|mITT Population|||mm||Standard Deviation|Mean
2546570|NCT02919761|Secondary|Part 2: Patient's Global Assessment of Pain by Visit|Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain.|Baseline, Week 12 to Week 24|mITT Population|||mm||Standard Deviation|Mean
2546571|NCT02919761|Secondary|Part 1: Patient's Global Assessment of Pain by Visit|Patients rate their pain on a 100 mm VAS, where 0=no pain and 100=pain as bad as it could be. Higher scores indicate more pain.|Baseline to Week 12|mITT Population|||mm||Standard Deviation|Mean
2546572|NCT02919761|Secondary|Part 2: Erythrocyte Sedimentation Rate (ESR) by Visit|"The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour.~The clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr).~The normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females.~The ESR is a common test for inflammation and used to derive the DAS28.~The DAS28 is a composite score derived from the following assessments:~Swollen Joint Count~Tender Joint Count~Patient's Global Health~Erythrocyte Sedimentation Rate"|Baseline, Week 12 to Week 24|mITT Population|||mm/hr||Standard Deviation|Mean
2546573|NCT02919761|Secondary|Part 1: Erythrocyte Sedimentation Rate (ESR) by Visit|"The ESR is the rate at which red blood cells (in whole blood that has not clotted) fall to the bottom of the tube over a period of one hour.~The clear liquid above the red blood cells is measured in millimeters after one hour (mm/hr).~The normal range for ESR results is 1-13 mm/hr for males and 1/20 mm/hr for females.~The ESR is a common test for inflammation and used to derive the DAS28.~The DAS28 is a composite score derived from the following assessments:~Swollen Joint Count~Tender Joint Count~Patient's Global Health~Erythrocyte Sedimentation Rate"|Baseline to Week 12|mITT Population|||mm/hr||Standard Deviation|Mean
2546574|NCT02919761|Secondary|Part 2: Patient-Reported General Health by Visit|"Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health.~A lower score indicates better general health."|Baseline, Week 12 to Week 24|mITT Population|||mm||Standard Deviation|Mean
2546575|NCT02919761|Secondary|Part 1: Patient-Reported General Health by Visit|"Participants rate their general health on a 100 mm visual analogue scale (VAS), where 0=best general health and 100=worst general health.~A lower score indicates better general health."|Baseline to Week 12|mITT Population|||mm||Standard Deviation|Mean
2546576|NCT02919761|Secondary|Part 2: Tender Joint Count by Visit|"The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)~The DAS28 is a composite score derived from the following assessments:~Swollen Joint Count~Tender Joint Count~Patient's Global Health~Erythrocyte Sedimentation Rate"|Baseline, Week 12 to Week 24|mITT Population|||Count of Tender Joints|Joints|Standard Deviation|Mean
2546577|NCT02919761|Secondary|Part 1: Tender Joint Count by Visit|"The investigator counts the number of tender joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)~The DAS28 is a composite score derived from the following assessments:~Swollen Joint Count~Tender Joint Count~Patient's Global Health~Erythrocyte Sedimentation Rate"|Baseline to Week 12|mITT Population|||Count of Tender Joints|Joints|Standard Deviation|Mean
2546578|NCT02919761|Secondary|Part 2: Swollen Joint Count by Visit During Part 2|"The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR/DAS28)~The DAS28 is a composite score derived from the following assessments:~Swollen Joint Count~Tender Joint Count~Patient's Global Health~Erythrocyte Sedimentation Rate"|Baseline, Week 12 to Week 24|mITT Population|||Count of swollen joints|Joints|Standard Deviation|Mean
2546579|NCT02919761|Secondary|Part 1: Swollen Joint Count by Visit|"The investigator counts the number of swollen joints used to calculate the Disease Activity Score (DAS28-ESR, DAS28)~The DAS28 is a composite score derived from the following assessments:~Swollen Joint Count~Tender Joint Count~Patient's Global Health~Erythrocyte Sedimentation Rate"|Baseline to Week 12|mITT|||Count of swollen joints|Joints|Standard Deviation|Mean
2546580|NCT02919761|Primary|Part 2: Number of Participants Who Maintained Low Disease Activity by Visit|Low disease activity is defined as DAS28 <3.2.|Week 12 to Week 24|mITT Population|||Participants|||Count of Participants
2546581|NCT02919761|Primary|Part 1: Number of Participants With Low Disease Activity (LDA) by Visit|LDA is defined as DAS28 <3.2.|Baseline to Week 12|modified Intent to Treat (mITT) Population|||Participants|||Count of Participants
2546582|NCT02919657|Primary|Weekly Blood Draws to Measure Blood Protein Levels|"Each week the 20 participants will have blood drawn to measure their blood protein levels.~Each participant was required to give blood weekly to determine the blood protein levels. The results show the average over each six week period of testing for each row. Each participant was examined to see if they achieved the average range as set fourth by the dieticians of greater than 6.1 and less than 8.7 within a 10% variable as acceptable.~10 Participants will be given Genepro Gen2 for the first six weeks of the study and whey protein for the final 6.~10 Participants will be given when protein for the first six weeks of the study and Genepro Gen2 for the final 6.~These measurements will read in g/dl"|6 weeks per intervention||||grams per deciliter||Standard Deviation|Mean
2546608|NCT02918630|Primary|Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back|Timeline follow-back involves asking participants to retrospectively estimate their cigarette use in the week prior to the interview date. An average number of cigarettes per day was calculated for each participant, and the average of the average number of cigarettes per day for all participants is reported below.|week 5||||number of cigarettes per day||Standard Deviation|Mean
2546583|NCT02919618|Secondary|Number of Participants With Reduction in Ventricular Tachycardia (VT) Therapies Between 6 and 12 Months|Evaluate longer-term durability endpoint of ENCORE treatment, as defined by number of patients with reduction in VT therapies (ATP or ICD shock or sustained (>30 sec) slow VT and ICD shock alone) during the early phase (treatment to 6 months, with 6 week blanking period) vs. the late phase (6 months to 1 year). For patients with PVC-induced cardiomyopathy, the longer-term durability efficacy will be persistence of any reduction in PVC burden based on ambulatory heart monitors during early phase vs. late phase.|12 months||||Participants|||Count of Participants
2546584|NCT02919618|Secondary|Number of Participants With Reduction in ICD Shocks and LVEF Improvement|Evaluate the most clinically useful efficacy endpoint of ENCORE treatment, namely, number of patients with reduction specifically in ICD shocks (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the most clinically useful efficacy will be improvement in cardiac function in the setting of any improvement in PVC burden.|6 months|One patient was excluded because they expired prior to the outcome measure time frame.|||Participants|||Count of Participants
2546585|NCT02919618|Secondary|Number of Participants With a 95% Reduction in Ventricular Tachycardia (VT) Burden|Evaluate strictest efficacy endpoint of ENCORE treatment, as defined by number of patients who have had 95% reduction in any VT (ATP or ICD shocks or sustained (>30 sec) slow VT) after ENCORE treatment (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the strictest efficacy will be abolition of PVC burden (<1%) based on ambulatory heart monitors.|6 months|One patient was excluded because they expired prior to the outcome measure time frame.|||Participants|||Count of Participants
2546586|NCT02919618|Secondary|Number of Participants With a 50% Reduction in Ventricular Tachycardia (VT) Burden|Evaluate stricter efficacy endpoint of ENCORE treatment, as defined by number of patients who have had 50% reduction in any VT therapies (ATP or ICD shocks or sustained (>30sec) nontreated slow VT) after ENCORE treatment (6 months before vs. 6 months after treatment, with a 6 week blanking period immediately after treatment). For patients with PVC-induced cardiomyopathy, the stricter efficacy will be >50% reduction in PVC burden based on ambulatory heart monitors.|6 months|One patient was excluded because they expired prior to the outcome measure time frame.|||Participants|||Count of Participants
2546587|NCT02919618|Secondary|Health Related Quality of Life (HRQOL)|The 36-Item Short Form Survey (SF-36) is a set of generic, coherent, and easily administered quality of life measures that rely on patient self-reporting. The SF-36 evaluates 8 domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scale values for each domain range from 0 to 100 where the higher score defines a more favorable health state.|6 week, 6 month, 12 month||||Scores on a Scale||Full Range|Mean
2546588|NCT02919618|Secondary|Number of Adverse Events That Are Possibly/Probably/Definitely Related to Study Treatment|Toxicities that occur after treatment, but are not acutely ascribed to treatment that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive catheter-based VT-ablation procedures, using the CTCAE v4.0 criteria.|90 days to 12 months|Analysis is based on number of AE events that occurred in 18 participants >90 days to 365 days post-SBRT.|||Number of Events|||Number
2546589|NCT02919618|Secondary|Overall Survival|Determine six-month and twelve-month survival (overall mortality endpoint) after treatment with ENCORE.|12 months||||Participants|||Count of Participants
2546590|NCT02919618|Primary|Number of Participants With Reduction in Ventricular Tachycardia (VT) Burden|"Primary efficacy endpoint is defined by the number of subjects with a reduction in VT burden comparing the period six months before ENCORE treatment to the six months after ENCORE treatment as adjudicated by continuous ICD monitoring (number of ATP and ICD shocks and sustained (>30 second) nontreated slow VT). There will be a six-week blanking period after therapy to allow for ablation effect. For patients with PVC-induced cardiomyopathy, the primary efficacy will be any reduction in PVC burden based on ambulatory heart monitors."|12 months (6mo prior to and 6mo post SBRT)|"Percent reduction of VT episodes or PVC burden 6 months post-SBRT compared to 6 months prior to SBRT.~Patients who were alive at 6 months were evaluated comparing ICD treatments or PVC burden 6 months before and 6 months post-SBRT."|||Participants|||Count of Participants
2546591|NCT02919618|Primary|Number of Serious Adverse Events|Demonstrate acute (≤ 90 days) safety of noninvasive stereotactic cardiac ablation radiotherapy (ENCORE). The primary safety endpoint is defined by a ≤ 20% rate of serious adverse events (SAEs) using CTCAE v4.0 criteria that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive catheter-based VT-ablation procedures.|< or = 90 days|Analysis is based on number of SAE events that occurred in 19 participants within 90 days after SBRT.|||Events|||Number
2546592|NCT02919423|Primary|Change in Functional Connectivity Strength Measured With Functional Magnetic Resonance Imaging|Difference in functional connectivity from the TMS target site to the right insula. The primary dependent variable was the resting-state functional connectivity strength between the TMS target site and the right insula.|baseline and 1 week||||correlation coefficient|||Number
2546593|NCT02919267|Secondary|Measurement of Intra-pulmonary Pressure in the Non-ventilated Lung With the Use of DLT and BB|We present the mean airway pressure at 10 minutes in both group. In the manuscript this secondary outcome in present as a graph with the mean pressures plotted each minutes until 10 minutes. Stats were done with two-way anova.|From the beginning of OLV until pleural opening||||cmH2O||Standard Error|Mean
2546594|NCT02919267|Primary|Quantification of Gas Volume Coming From Ambient Air Towards the Alveoli Space of the Non-ventilated Lung During OLV With the Use of DLT and BB.||From the beginning of OLV until 60 minutes||||milliliters (mL)||Standard Error|Mean
2546595|NCT02919007|Primary|Usability Assessment|Study success is determined according to the ability of all subjects to complete device related tasks, including applying and operating the Device without assistance in a timeframe of up to 1 hour and with minimal attempts to ask for assistance.|1 hour||||Participants|||Count of Participants
2546609|NCT02918630|Secondary|Feasibility as Assessed by Percent of Participants Who Completed the Study||week 5||||percent of participants|||Number
2551301|NCT02819804|Secondary|PD1 Expression Levels and Saturation Assessed in the Peripheral Blood|Peripheral blood will be evaluated to measure PD1 expression levels and saturation.|Baseline to 28-days after the last dose|||||||
2546596|NCT02918773|Secondary|Clinician Acceptability of the Smartphone Otoscopic Device|Clinicians randomized to use the smartphone otoscopic device completed a survey to assess the acceptability of this device compared to the historical use of a conventional otoscope. The survey, developed specifically for this study, asked clinicians to report on their preference for using the smartphone otoscope over the conventional otoscope, whether the device increased their ability to diagnose AOM, and the perceived impact on antibiotic prescribing.|Month 6|Only participating clinicians who were randomized to use the smartphone otoscope were administered a survey at the end of the 6-month intervention.|||Participants|||Count of Participants
2546597|NCT02918773|Secondary|Number of Diagnoses of Otitis Externa|The number of emergency department encounters where a diagnosis of otitis externa was made is presented here. Information about the diagnosis of otitis externa was found in the medical records of children receiving an otoscopic exam by a participating clinician.|Month 6||||Emergency department encounters|Clinic encounters||Number
2546598|NCT02918773|Secondary|Number of Diagnoses of Acute Otitis Media (AOM)|The number of emergency department encounters where a diagnosis of acute otitis media (AOM) was made is presented here. Information about the diagnosis of AOM was found in the medical records of children receiving an otoscopic exam by a participating clinician.|Month 6||||Emergency department encounters|Clinic encounters||Number
2546599|NCT02918773|Primary|Number of Antibiotic Prescriptions|The number of emergency department encounters where antibiotics were prescribed to treat acute otitis media (AOM) are presented here. Information about antimicrobial prescriptions were found in the medical records of children receiving an otoscopic exam by a participating clinician.|Month 6|This analysis includes emergency department encounters with children by a participating clinician where AOM was diagnosed.|||Emergency department encounters|Number of encounters||Number
2546600|NCT02918669|Post-Hoc|Fracture Healing|"0 N/A; no spinous process fracture reported~Not healed; no evidence of a spinous process fracture healing~Healed; presence of a healed spinous process fracture~Remodeled; fracture line is absent due to bone remodeling at the site of a previously detected fracture~Indeterminate - no follow-up imaging available; no images are available at time points later than the time point when the fracture was identified~Indeterminate - inadequate image quality; the quality of available images is inadequate to determine the fracture healing status~Indeterminate - implant obscures fracture; the coflex implant obscures visualization of the fracture line so healing cannot be determined"|>/= 5 years||||fractures|||Number
2546601|NCT02918669|Post-Hoc|Fracture Displacement|"0 N/A; no spinous process fracture reported~Non-displaced; no evidence of a displaced spinous process fracture~Displaced; presence of a displaced spinous process fracture. No contact between the fragment and the remaining vertebra should exist, and at least 2 mm wide gap should exist at a point along the fracture gap~Indeterminate; assessment cannot be made due to technical factors such as obscured anatomy due to the device wings, poor contrast, high parallax or significant artifacts that result in images being of non-diagnostic quality"|>/= 5 years||||fractures|||Number
2546602|NCT02918669|Post-Hoc|Fracture Location|"0 None; no evidence of spinous process fracture~Posterior avulsion; presence of a fracture pattern consistent with lumbar spinous process avulsion fractures~Posterior to implant wings; presence of a spinous process fracture posterior~Coincident with implant wings: presence of a spinous process fracture in the same coronal plane as the implant wings~Anterior to implant wings; presence of a spinous process fracture anterior to the implant wings~Indeterminate; assessment cannot be made due to technical factors such as obscured anatomy due to the device wings, poor contrast, high parallax or significant artifacts that result in images being of non-diagnostic quality"|>/= 5 years||||fractures|||Number
2546603|NCT02918669|Primary|Number of Participants With Radiographic Analysis of Evidence of Fracture or Healing Based on CT Scan|Any coflex patients with radiographic observations of spinous process fracture at post-24 months, will be examined via CT at 5 years for evidence of fracture or of healing.|Post-60 Months|To examine the long-term survivorship via CT Scan of the coflex in patients who presented with spinous process fractures at 24 months in the Paradigm Spine coflex IDE Study.|||Participants|||Count of Participants
2546604|NCT02918656|Secondary|Health Numeracy Score|This section will use 6-item General health numeracy test (Osborne et al., 2013) in order to determine how much our participants understand the basic health instructions regarding numeracy dimension. For each correct answer, the participants receive one point and the total score is the sum of all correct answers.|One hour after the intervention||||units on a scale||Inter-Quartile Range|Median
2546605|NCT02918656|Secondary|Accessibility of Relevant Information|This section of the survey will have 5 questions concerning how easy it was for the participant to find relevant information, measured by a 10-point Likert type scale where the answer 1 means I do not agree at all and 10 means I fully agree. The total score is the sum of scores on all the answers (minimum score was 5, maximum 50). The higher score indicated that the reading material was perceived as more user friendly and that it was easier to find the desired information.|One hour after the intervention||||units on a scale||95% Confidence Interval|Median
2546606|NCT02918656|Secondary|Reading Experience|This section of the survey will include 5 questions about the experience of participants about the text they read, measured on a 10-point Likert type scale, where 1 means do not agree at all and 10 means fully agree. The total score is the sum of scores on all five answers (minimum score was 10 and maximum 50). Higher scores indicate greater reading experience, which means that a person was assessed that type of reading material as more enjoyable. So, higher scores are associated with more positive reading experience.|One hour after the intervention||||units on a scale||95% Confidence Interval|Median
2546607|NCT02918656|Primary|Understanding|"The primary outcome of the study is the score on a understanding test with ten questions about information contained in all three forms of presentation, titled as Understanding information about external cephalic version for breech presentation before term (Hutton et al, 2015). The questions will focus on understanding the benefits and risks of the intervention and the quality of evidence described in the systematic review. Each correctly answered question will be awarded one point, with a maximum of 10 points. The scale was specifically designed for this research, they ask about the information contained in all three abstract format and all questions are open-ended."|One-hour after the intervention||||units on a scale||95% Confidence Interval|Median
2546639|NCT02918552|Other Pre-specified|Co-morbidity Medications|Medications for comorbidity managment|Week 1 pre drug to week 16 post drug|||||||
2546610|NCT02918630|Primary|Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back|Timeline follow-back involves asking participants to retrospectively estimate their cigarette use in the week prior to the interview date. An average number of cigarettes per day was calculated for each participant, and the average of the average number of cigarettes per day for all participants is reported below.|Baseline||||number of cigarettes per day||Standard Deviation|Mean
2546611|NCT02918630|Primary|Change in Smoking as Assessed by Urinary Cotinine Levels||Baseline, Week 5||||ng/mL||Standard Deviation|Mean
2546612|NCT02918630|Primary|Change in Smoking as Assessed by Breath Carbon Monoxide Levels||Baseline, Week 5||||parts per million (ppm)||Standard Deviation|Mean
2546613|NCT02918617|Primary|Percentage Change From Baseline in DPS (Dental Pain Scale) With Cold Stimulation|Patient's response to an cold stimulus is recorded on a Dental Pain Scale (none[1]-mild[2]-moderate[3]-severe[4]).|Baseline to 8 weeks||||percentage change from baseline||Standard Error|Mean
2546614|NCT02918617|Primary|Percentage Change From Baseline in DPS (Dental Pain Scale) With Air Stimulation|Patient's response to an air stimulus is recorded on a Dental Pain Scale (none[1]-mild[2]-moderate[3]-severe[4]).|Baseline to 8 weeks||||percentage change from baseline||Standard Error|Mean
2546615|NCT02918617|Primary|Percentage Change From Baseline in VAS (Visual Analog Scale) With Cold Stimulation|Patient's response to cold stimulus is recorded on a Visual Analog Scale of 0-100 with 0 signifying no pain and 100 signifying the worst possible pain|Baseline to 8 weeks||||percentage change from baseline||Standard Error|Mean
2546616|NCT02918617|Primary|Percentage Change From Baseline in VAS (Visual Analog Scale) With Air Stimulation|Patient's response to an air stimulus is recorded on a Visual Analog Scale of 0-100 with 0 representing no pain and 100 representing the worst possible pain.|Baseline to 8 weeks||||percentage change from baseline||Standard Error|Mean
2546617|NCT02918552|Secondary|Moderate to Vigorous Physical Activity Percentage From Accelerometry Assessment of Daily Activity|"Assessment of daily activity using accelerometry on a daily-wear wrist device.~MVPA is Moderate-to-vigorous physical activity that is a triggered stint of time that the patient has a slightly elevated amount of activity based on biometrics such as movement and heart rate."|Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks|Only 6 subjects in either arm had functioning accelerometers with data that could be extracted and analyzed.|||Percentage of day||Standard Deviation|Mean
2546618|NCT02918552|Secondary|Light Activity Events Percentage of Day From Accelerometry Assessment of Daily Activity|"Assessment of daily activity using accelerometry on a daily-wear wrist device.~Light activity is a triggered stint of time that the patient has a slightly elevated amount of activity based on biometrics such as movement and heart rate."|Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks|Only 6 subjects in either arm had functioning accelerometers with data that could be extracted and analyzed.|||% of day||Standard Deviation|Mean
2546619|NCT02918552|Secondary|Sedentary Event Duration From Accelerometry Assessment of Daily Activity|"Assessment of daily activity using accelerometry on a daily-wear wrist device.~Sedentary bout is a triggered stint of time that the patient is not moving or has low level of activity sensed by the accelerometer."|Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks|Only 6 subjects in either arm had functioning accelerometers with data that could be extracted and analyzed.|||minutes/bout||Standard Deviation|Mean
2546620|NCT02918552|Other Pre-specified|Thyroid Stimulating Hormone|Change in thyroid stimulating hormone (TSH)|Week 5 (pre drug) to week 16 (post drug); approx. 8 weeks|||||||
2546621|NCT02918552|Other Pre-specified|Self-efficacy|Change in pre and post scores on the Sullivan Cardiac Self Efficacy questionnaire|Week 2(pre drug) to Week 10( post drug); approx. 8 weeks|||||||
2546622|NCT02918552|Other Pre-specified|Submaximal Exercise Performance|Change in distance on six minute walk test|Week 2(pre drug) to Week 10( post drug); approx. 8 weeks|||||||
2546623|NCT02918552|Other Pre-specified|Quality of Life|Change in pre and post scores on the Kansas City Cardiomyopathy Questionnaire subject self reported responses|Week 2(pre drug) to Week 10( post drug); approx. 8 weeks|||||||
2546624|NCT02918552|Other Pre-specified|Physical Activity|Change in pre and post scores on the CHAMPS (Community Healthy Activities Program for Seniors) Activities Questionnaire for Older Adults-physical activity|Week 2(pre drug) to Week 10( post drug); approx. 8 weeks|||||||
2546625|NCT02918552|Other Pre-specified|Physical Frailty and Balance|Change in score on Standard Physical Performance Battery at visit 2 pre drug and visit 5|Week 2(pre drug) to Week 10( post drug); approx. 8 weeks|||||||
2546626|NCT02918552|Other Pre-specified|Pain|Change in pre and post scores on the McGill Pain Questionnaire|Week 2(pre drug) to Week 10( post drug); approx. 8 weeks|||||||
2546627|NCT02918552|Other Pre-specified|Near Infrared Spectroscopy|Assessment of blood flow during exercise|Week 2(pre drug) to Week 10( post drug); approx. 8 weeks|||||||
2546628|NCT02918552|Other Pre-specified|Muscle Protein|Change in protein content of muscle fiber|Week 5 (pre drug) to week 16 (post drug); approx. 8 week|||||||
2546629|NCT02918552|Other Pre-specified|Hemodynamics; Heart Rate|Change in heart rate|Week 1 pre drug to week 16 post drug|||||||
2546630|NCT02918552|Other Pre-specified|Hemodynamics; Blood Pressure|Change in Blood pressure|Week 1 pre drug to week 16 post drug|||||||
2546631|NCT02918552|Other Pre-specified|Hemoglobin|Change in hemoglobin|Week 1 pre drug to week 16 post drug|||||||
2546632|NCT02918552|Other Pre-specified|Hematocrit|Change in hematocrit|Week 1 pre drug to week 16 post drug|||||||
2546633|NCT02918552|Other Pre-specified|Glycosylated Hemoglobin|Change in glycosylated hemoglobin (HgbA1c)|Week 5 (pre drug) to week 16 (post drug); approx. 8 week|||||||
2546634|NCT02918552|Other Pre-specified|Glomerular Filtration Rate|Change in glomerular filtration rate (GFR)|Week 5 (pre drug) to week 16 (post drug); approx. 8 week|||||||
2546635|NCT02918552|Other Pre-specified|Gene Expression|Change in DNA from Polymerase Chain Reaction analysis|Week 5 (pre drug) to week 16 (post drug); approx. 8 week|||||||
2546636|NCT02918552|Other Pre-specified|Frailty Index Assessment|Physician assessment of frailty using the Canadian Clinical Frailty Scale|Week 1 screening pre-drug to week 16 post drug|||||||
2546637|NCT02918552|Other Pre-specified|Fatigability|Change in pre and post scores on the Pittsburgh Fatigability Index|Week 2(pre drug) to Week 10( post drug); approx. 8 weeks|||||||
2546638|NCT02918552|Other Pre-specified|Echocardiogram|Change in cardiac strain|Week 1 pre-drug to week 16 post drug|||||||
2546647|NCT02918552|Secondary|Vector Magnitude Counts From Accelerometry Assessment of Daily Activity|"Assessment of daily activity using accelerometry on a daily-wear wrist device.~Vector Magnitude in counts per day are accelerations in 3 dimensions that indicate activity. More counts is associated with more activity. More counts in a shorter duration of time indicate light, moderate, and vigorous activity."|Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks|Only 6 subjects in either arm had functioning accelerometers with data that could be extracted and analyzed.|||Counts/day||Standard Deviation|Mean
2546648|NCT02918552|Secondary|Moderate to Vigorous Physical Activity From Accelerometry Assessment of Daily Activity|"Assessment of daily activity using accelerometry on a daily-wear wrist device.~MVPA is Moderate-to-vigorous physical activity that is a triggered stint of time that the patient has a slightly elevated amount of activity based on biometrics such as movement and heart rate."|Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks|Only 6 subjects in either arm had functioning accelerometers with data that could be extracted and analyzed.|||minutes/day||Standard Deviation|Mean
2546649|NCT02918552|Secondary|Light Activity Duration From Accelerometry Assessment of Daily Activity|"Assessment of daily activity using accelerometry on a daily-wear wrist device.~Light activity is a triggered stint of time that the patient has a slightly elevated amount of activity based on biometrics such as movement and heart rate."|Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks|Only 6 subjects in either arm had functioning accelerometers with data that could be extracted and analyzed.|||seconds/day||Standard Deviation|Mean
2546650|NCT02918552|Secondary|Sedentary Events From Accelerometry Assessment of Daily Activity|"Assessment of daily activity using accelerometry on a daily-wear wrist device.~Sedentary bout is a triggered stint of time that the patient is not moving or has low level of activity sensed by the accelerometer."|Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks|Only 6 subjects in either arm had functioning accelerometers with data that could be extracted and analyzed.|||bouts/day||Standard Deviation|Mean
2546651|NCT02918552|Secondary|Steps From Accelerometry Assessment of Daily Activity|Actigraph device-specific activity steps on daily-wear wrist device based on movement.|Week 1(pre-drug) to week 16(post-drug); approx. 16 weeks|Only 6 subjects in either arm had functioning accelerometers with data that could be extracted and analyzed.|||Counts/day||Standard Deviation|Mean
2546652|NCT02918552|Secondary|Patients With Pulmonary Hypertension|Right Ventricular-Pulmonary Artery Coupling, assessed by right ventricular ejection fraction (RVEF) and pulmonary artery systolic pressure (PASP), decreases with worsening right heart failure. We will be measuring this by assessing RVEF and PASP during invasive cardiopulmonary exercise testing in patients that meet criteria for pulmonary hypertension.|Week 3 (pre-drug) to week 10 (post drug); approx 8 weeks|Smaller amount of subjects were analyzed due to unexpected problems with specialized testing equipment availability.|||Participants|||Count of Participants
2546653|NCT02918552|Secondary|Exercise-induced Changes in Pulmonary Capillary Wedge Pressure|Pulmonary capillary wedge pressure, an indication of cardiopulmonary hemodynamics and cardiac function, was measured at rest and at peak exercise during an invasive cardiopulmonary exercise test.|Week 3 (pre-drug) to week 10 (post drug); approx 8 weeks|Smaller amount of subjects were analyzed due to unexpected problems with specialized testing equipment availability.|||mmHg||Standard Deviation|Mean
2546654|NCT02918552|Secondary|Exercise-induced Changes in Pulmonary Arterial Pressure|Pulmonary arterial pressure, an indication of cardiopulmonary hemodynamics and cardiac function, was measured at rest and at peak exercise during an invasive cardiopulmonary exercise test.|Week 3 (pre-drug) to week 10 (post drug); approx 8 weeks|Smaller amount of subjects were analyzed due to unexpected problems with specialized testing equipment availability.|||mmHg||Standard Deviation|Mean
2546655|NCT02918552|Secondary|Bioenergetics: Ex-Vivo Mitochondrial Respiration Analysis|Mitochondrial respiration was analyzed by assessing O2 consumption by skeletal muscle mitochondria at Energetic State 3.1 using the Oroboros instrument. This state is generally used a marker for mitochondrial efficiency. Increases in consumption are generally linked to a better outcome.|Week 5 (pre-drug) to week 16 (post-drug); approx. 8 weeks|Smaller amount of subjects were analyzed due to unexpected problems with specialized testing equipment availability.|||pmol/(s*mg)||Standard Deviation|Mean
2546656|NCT02918552|Secondary|Bioenergetics: In-Vivo 31P MRS Respirations|Phosphocreatine reuptake after exercise during the kicking exercise in the 31P MRS (magnetic resonance spectroscopy)|Week 3 (pre drug) to week 10(post drug); approx. 8 weeks|Magnetic resonance spectroscopy equipment had unexpected limited availability, which is why so few participants were analyzed.|||1/s||Standard Deviation|Mean
2546657|NCT02918552|Secondary|Perceived Fatigability|Assessment of Rate of Perceived Exertion (RPE) during steady state exercise testing at the last minute of the test. The RPE scale (Rate of Perceived Exertion) goes from 6-20 with a higher number indicating more effort and possibly a worse outcome.|Week 2(pre drug) to Week 10( post drug); approx. 8 weeks|"In the treatment arm, a subject withdrew after pre-treatment testing.~1 subject from the control arm withdrew after randomization but before testing. A second withdrew prior after pre-treatment testing, but before post-treatment testing."|||Units on a scale||Standard Deviation|Mean
2546658|NCT02918552|Primary|Cardiorespiratory Fitness|Assessment of peak Oxygen uptake (VO2) maximum via symptom limited exercise testing|Week 2(pre drug) to Week 10( post drug); approx. 8 weeks|"In the treatment arm, a subject withdrew after pre-treatment testing.~1 subject from the control arm withdrew after randomization but before testing. A second withdrew prior after pre-treatment testing, but before post-treatment testing."|||ml/kg/min||Standard Deviation|Mean
2546659|NCT02918396|Primary|Recurrence of Atrial Fibrillation (AF) > 30 Seconds|Primary outcome is defined as symptomatic or asymptomatic AF of at least 30 seconds duration that is documented by an ECG or mobile rhythm monitoring device (AliveCor), occurring after the 3-month blanking period following catheter ablation and up to 12 months.|Following the 90 day blanking period up to 12 months post-index pulmonary vein isolation||||Participants|||Count of Participants
2546660|NCT02918357|Secondary|Safety Assessment - Blood Pressure|Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.|1 day|Pressure exerted by a 1 millimeter vertical column of mercury (Hg) at 0 degree Celsius is defined as (mmHg)|||mmHg||Standard Deviation|Mean
2546661|NCT02918357|Secondary|Safety Assessment - Heart Rate|Patient vital signs were measured before and after 68Ga-PSMA-11 injections and absolute mean change was calculated.|1 day||||beats per minute||Standard Deviation|Mean
2546664|NCT02918357|Secondary|Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value|Detection rate was defined as proportion of 68Ga-PSMA-11 PET positive patients, independent of the reference standard stratified by PSA value (0.2-<0.5; 0.5-<1.0; 1.0-<2.0; 2.0-<5.0, and ≥5.0).|1 month|Portion of patients with 68Ga-PSMA-11 PET positive findings were stratified by PSA range and disease location in accordance with Prostate Magnetic Resonance Imaging Study (PROMIS)|||percentage detected|||Number
2546665|NCT02918357|Secondary|Sensitivity on a Per-region Basis|Sensitivity, on a per-region basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method.|1 month|Eighty-four patients had confirmed histopathology region validation for this analysis|||percentage of sensitivity||95% Confidence Interval|Number
2546666|NCT02918357|Secondary|Sensitivity on a Per-patient Basis|Sensitivity, on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy was calculated. The 95% CI was calculated using the Wilson score method.|1 month|Seventy-nine patients had confirmed patient histopathology validation for this analysis|||percentage of sensitivity||95% Confidence Interval|Number
2546667|NCT02918357|Secondary|PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up|PPVs on a per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI.|1 month|Two-hundred and forty-nine patients had confirmed regional imaging in follow up for this sample.|||percentage of times value is true||95% Confidence Interval|Number
2546668|NCT02918357|Secondary|PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up|PPVs on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by conventional imaging follow-up were calculated and reported along with the corresponding two-sided 95% CI.|1 month|One hundred and twenty-five patients had confirmed imaging at follow-up for this analysis|||percentage of times value is true||95% Confidence Interval|Number
2546669|NCT02918357|Primary|Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation|PPVs were calculated across the group on a per-region-basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% CIs. The CIs were constructed using the Wilson score method.|1 month|All subjects who received a 68Ga-PSMA-11 injection, had their 68Ga-PSMA-11 scan independently and blindly interpreted on a per region basis. Per region analyses included an evaluation of positive or negative for presence of PCa. Regional analyses included prostate bed, pelvic nodes, extrapelvic non-bone, and bone.|||percentage of times value is true||95% Confidence Interval|Number
2546670|NCT02918357|Primary|Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation|PPVs were calculated across the group on a per-patient basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% confidence intervals (CI). The CIs were constructed using the Wilson score method.|1 month|All subjects who received a 68Ga-PSMA-11 injection, had their 68Ga-PSMA-11 scan independently and blindly interpreted on a per patient basis. Per patient analyses included an evaluation of positive or negative for presence of localized prostate cancer (PCa).|||percentage of times value is true||95% Confidence Interval|Number
2546671|NCT02918279|Secondary|Change in PHQ-9|Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. The PHQ-9 total score ranges from 0−27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15−19 represent moderately severe depression and total scores of 20-27 represent severe depression. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2546672|NCT02918279|Secondary|Change in C-SSRS|"This outcome measure presents number of subjects with suicidal ideation or suicidal behaviour on the Columbia Suicidality Severity Rating Scale (C-SSRS) assessed at baseline (week 0), week 30, week 56 and week 82. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82."|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||Participants|||Count of Participants
2546673|NCT02918279|Secondary|Change in Height SDS|Change in height standard deviation score (SDS) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below −3 and above 3, the score was adjusted as described in the WHO instruction. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||SDS||Standard Deviation|Mean
2546695|NCT02918279|Secondary|Change in Haematology: Haematocrit|Change in haematocrit was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||% of red blood cells||Standard Deviation|Mean
2546674|NCT02918279|Secondary|Change in Physical Examination|"This outcome measure presents number of subjects with physical examination findings, normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS) at baseline (week 0), week 30, week 56 and week 82. These findings were categorised by the investigator. Results include examination of: general appearance; head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system (CVS); gastrointestinal (GI) system including mouth; musculoskeletal system; central nervous system (CNS) and peripheral nervous system (PNS); skin; thyroid gland and lymph node palpation. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82."|Week 0, week 30, week 56 and week 82|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||Participants|||Count of Participants
2546675|NCT02918279|Secondary|Change in Pubertal Status|"This outcome measure presents pubertal status results which is based on Tanner staging (Tanner stage 2-5), recorded at baseline (week 0), week 30, week 56 and week 82. Results are presented for the following categories: 1) For female: breast development and pubic hair development (by Tanner staging). 2) For male: penis development and pubic hair development (by Tanner staging). Each category shows number of participants in stages 2 to 5, where stage 2 represents early pubertal development and stage 5 represents pubertal development equivalent to that of an adult. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82."|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||Participants|||Count of Participants
2546676|NCT02918279|Secondary|Change in Alkaline Phosphatase (Bone)|Change in alkaline phosphatase (bone specific) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||U/L||Standard Deviation|Mean
2546677|NCT02918279|Secondary|Change in P1NP|Change in procollagen 1 N-terminal propeptide (P1NP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||ng/mL||Standard Deviation|Mean
2546678|NCT02918279|Secondary|Change in CTX1|Change in type I collagen C-telopeptide (CTX1) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||pg/mL||Standard Deviation|Mean
2546679|NCT02918279|Secondary|Change in NTX1|"Change in type I collagen N-telopeptide (NTX1) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are presented in nmol bone collagen equivalents (BCE)/L. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82."|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||nmol BCE/L||Standard Deviation|Mean
2546680|NCT02918279|Secondary|Change in Hormone Level: Testosterone (Males)|"This outcome measure presents testosterone (only for males) results for baseline (week 0), week 30, week 56 and week 82. ADVIA Centaur Testosterone (TSTO) assay was used for the evaluation of testosterone hormone. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82."|Week 0, week 30, week 56 and week 82|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||nmol/L||Standard Deviation|Mean
2546681|NCT02918279|Secondary|Change in Hormone Level: Estradiol (Females)|Change in estradiol (only for female) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||pg/mL||Standard Deviation|Mean
2546682|NCT02918279|Secondary|Change in Hormone Level: LH and FSH|"Change in hormone levels, luteinising hormone (LH) and follicle stimulating hormone (FSH) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82."|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||IU/L||Standard Deviation|Mean
2546683|NCT02918279|Secondary|Change in Hormone Level: DHEAS|Change in dehydroepiandrosterone sulfate (DHEAS) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||umol/L||Standard Deviation|Mean
2546684|NCT02918279|Secondary|Change in Hormone Level: IGF-1 and Cortisol|"Change in hormone levels, insulin-like growth factor-1 (IGF-1) and cortisol was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82."|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||ng/mL||Standard Deviation|Mean
2546685|NCT02918279|Secondary|Change in Hormone Level: Free T4 and ACTH|"Change in hormone levels, thyroxine (T4) and adrenocorticotropic hormone (ACTH) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82."|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||pmol/L||Standard Deviation|Mean
2546686|NCT02918279|Secondary|Change in Hormone Level: TSH and Prolactin|"Change in hormone levels, thyroid stimulating hormone (TSH) and prolactin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82."|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||mIU/L||Standard Deviation|Mean
2546687|NCT02918279|Secondary|Change in Hormone Level: Calcitonin|Change in calcitonin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||ng/L||Standard Deviation|Mean
2546688|NCT02918279|Secondary|Change in Biochemistry: CEA|Change in carcinoembryonic antigen (CEA) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||ng/mL||Standard Deviation|Mean
2546689|NCT02918279|Secondary|Change in Biochemistry: Albumin|Change in albumin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||g/dL||Standard Deviation|Mean
2546690|NCT02918279|Secondary|Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected|"Change in biochemistry parameters, urea (blood urea nitrogen [BUN]), sodium, potassium, calcium total and calcium (Ca) albumin-corrected was evaluated from baseline (week [Wk] 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82."|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2546691|NCT02918279|Secondary|Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP|"Change in biochemistry parameters, creatinine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82."|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||U/L||Standard Deviation|Mean
2546692|NCT02918279|Secondary|Change in Biochemistry: Creatinine and Bilirubin (Total)|Change in creatinine and bilirubin (total) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||umol/L||Standard Deviation|Mean
2546693|NCT02918279|Secondary|Change in Haematology: Erythrocytes|Change in erythrocytes was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||10^12 cells/L||Standard Deviation|Mean
2546694|NCT02918279|Secondary|Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes|"Change in haematological parameters, thrombocytes, leucocytes, eosinophils, neutrophils, basophils, lymphocytes and monocytes was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82."|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||10^9 cells/L||Standard Deviation|Mean
2546696|NCT02918279|Secondary|Change in Haematology: Haemoglobin|Change in haemoglobin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2546697|NCT02918279|Secondary|Change in ECG|"This outcome measure presents number of subjects with electrocardiogram findings, normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS) recorded at baseline (week -14), week 30 and week 56. These findings were categorised by the investigator. Electrocardiogram (ECG) data at week 82 was not collected, thus could not be evaluated. Week 30 and 56 results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56."|Week -14, week 30, week 56 and week 82|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||Participants|||Count of Participants
2546698|NCT02918279|Secondary|Change in Pulse|Change in pulse was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||Beats/minute||Standard Deviation|Mean
2546699|NCT02918279|Secondary|Occurrence of Anti-liraglutide Antibodies|This outcome measure is only applicable for the liraglutide 3.0 mg treatment arm. Number of participants who measured with anti-liraglutide binding antibodies at weeks 0, 30, 56, 58, 70 and 82 are presented.|Weeks 0, 30, 56, 58, 70 and 82|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||Participants|||Count of Participants
2546700|NCT02918279|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification)|Severe hypoglycaemia episodes were recorded as per the ISPAD definition. And the following presented hypoglycaemia episodes were recorded as per Novo Nordisk definition: Symptomatic BG-confirmed: An episode that is blood glucose (BG) confirmed by plasma glucose (PG) value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Asymptomatic BG-confirmed: An episode that is BG-confirmed by PG value <3.1 mmol/L without symptoms consistent with hypoglycaemia. 4) Severe or BG-confirmed symptomatic: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. 5) BG-confirmed: An episode that is BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 6) Severe or BG-confirmed: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia.|Week 0-56 + 14 days|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS.|||Episodes|||Number
2546701|NCT02918279|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification)|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 14 days after the last day on randomised treatment. Severe hypoglycaemia episodes were recorded as per international society for pediatric and adolescent diabetes (ISPAD) definition. And the following presented hypoglycaemia episodes were recorded as per American Diabetes Association (ADA) definition: asymptomatic hypoglycaemia, documented symptomatic hypoglycaemia, pseudo-hypoglycaemia and probable symptomatic hypoglycaemia.|Week 0-56 + 14 days|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS.|||Episodes|||Number
2546702|NCT02918279|Secondary|Number of Treatment Emergent Adverse Events|"A treatment emergent adverse event (TEAE) was defined as an event that occurred in the on-treatment period. 'On-treatment' period: Events with onset date between the first day of trial product administration and any of the following date, whichever came first: 1) 14 days after the last day on trial product, or 2) follow-up visit (week 58) for participants who discontinued trial product, or 3) last study visit (participants withdrawn without follow-up visit)."|Week 0-56 + 14 days|Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS.|||Events|||Number
2546703|NCT02918279|Secondary|Change in Nutritional Compliance|"This outcome measure presents nutritional compliance results recorded at baseline (week 0), week 30 and week 56. Nutritional compliance was recorded on a 0 to 10 numeric rating scale, with higher scores representing better compliance. Week 30 and 56 results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56."|Week 0, week 30 and week 56|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2546704|NCT02918279|Secondary|Change in BMI SDS (%)|Relative change in BMI SDS was evaluated from baseline (week 0) to weeks 30 and 56. Results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56.|(Week 0, week 30); (Week 0, week 56)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Percentage change||Standard Error|Least Squares Mean
2546724|NCT02918279|Secondary|Change in Body Weight (lb)|Body weight was not analysed in pounds (lb). It was analysed for standard unit, 'kg' only.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Body weight was not analysed in pounds (lb).||||||
2551302|NCT02819804|Secondary|Serum Level of Nivolumab|The serum level of nivolumab will be measured on days 8, 15, and 22 prior to treatment during cycle 1.|Days 8, 15, and 22 prior to treatment during cycle 1|||||||
2546705|NCT02918279|Secondary|Change in IWQOL-Kids|Change in Impact of Weight on Quality of Life-Kids (IWQOL-Kids) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. The IWQOL-Kids is a 27-item measure of weight-related quality of life. There are four domain scores (Physical Comfort, Body Esteem, Social Life and Family Life) and a total score. Scores for all domains and total score range from 0-100, with higher scores representing better health-related quality of life. IWQOL-kids data at week 82 was not collected, thus could not be evaluated. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Scores on a scale||Standard Deviation|Mean
2546706|NCT02918279|Secondary|Change in HOMA-IR (Ratio to Baseline)|Change in homeostasis model assessment of insulin resistance (HOMA-IR) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting insulin [mU/L] x FPG [mmol/L]/ 22.5. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Ratio of HOMA-IR||Geometric Coefficient of Variation|Geometric Mean
2546707|NCT02918279|Secondary|Change in HOMA-B (Ratio to Baseline)|Change in homeostasis model assessment of beta-cell function (HOMA-B) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin[mU/L]/(FPG[mmol/L]-3.5). Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Ratio of HOMA-B||Geometric Coefficient of Variation|Geometric Mean
2546708|NCT02918279|Secondary|Change in Glycaemic Category|"Number of participants in glycaemic categories, normoglycaemia, pre-diabetes and type 2 diabetes (T2DM) at baseline (weeks -2), and weeks 30, 56 and 82 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: FPG <5.6 mmol/L (<100 mg/dL) and/or HbA1c <5.7%. 2) Pre-diabetes: FPG 5.6−6.9 mmol/L (both inclusive), FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7−6.4% (both inclusive). 3) Type 2 diabetes (T2DM): FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82."|Week -2, week 30, week 56 and week 82|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Participants|||Count of Participants
2546709|NCT02918279|Secondary|Change in Fasting C-peptide (Ratio to Baseline)|Change in fasting C-peptide from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Ratio of fasting C-peptide||Geometric Coefficient of Variation|Geometric Mean
2546710|NCT02918279|Secondary|Change in Fasting Insulin (Ratio to Baseline)|Change in fasting insulin from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Ratio of fasting insulin||Geometric Coefficient of Variation|Geometric Mean
2546711|NCT02918279|Secondary|Change in FPG|Change in fasting plasma glucose (FPG) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed treatment for the corresponding treatment period (week 0-30, week 0-56 or week 0-82).|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2546712|NCT02918279|Secondary|Change in HbA1c|Change in glycosylated haemoglobin (HbA1c) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2546713|NCT02918279|Secondary|Change in Systolic and Diastolic Blood Pressure|Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||mmHg||Standard Deviation|Mean
2546714|NCT02918279|Secondary|Change in Fasting Lipid: FFA (Ratio to Baseline)|Change in free fatty acids (FFA) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Ratio of FFA||Geometric Coefficient of Variation|Geometric Mean
2546715|NCT02918279|Secondary|Change in Fasting Lipid: Triglycerides (Ratio to Baseline)|Change in triglycerides from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Ratio of triglycerides||Geometric Coefficient of Variation|Geometric Mean
2546716|NCT02918279|Secondary|Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline)|Change in very low density lipoprotein (VLDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Ratio of VLDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2546717|NCT02918279|Secondary|Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline)|Change in non-HDL cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Ratio of non-HDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2546718|NCT02918279|Secondary|Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline)|Change in high density lipoprotein (HDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Ratio of HDL-cholesterol||Geometric Coefficient of Variation|Geometric Mean
2546719|NCT02918279|Secondary|Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline)|Change in low density lipoprotein (LDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Ratio of LDL-cholesterol||Geometric Coefficient of Variation|Geometric Mean
2546720|NCT02918279|Secondary|Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline)|Change in total cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Ratio of total cholesterol||Geometric Coefficient of Variation|Geometric Mean
2546721|NCT02918279|Secondary|Change in hsCRP|Change in high sensitivity C reactive protein (hsCRP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the safety analysis set (SAS) which included all randomised participants exposed to at least one dose of trial product. “Overall Number of Participants Analyzed” = SAS. “Number Analyzed” = number of participants with available data.|||mg/L||Standard Deviation|Mean
2546722|NCT02918279|Secondary|Change in Waist-to-hip Circumference Ratio|Change in waist-to-hip circumference ratio was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Ratio||Standard Deviation|Mean
2546723|NCT02918279|Secondary|Change in Waist Circumference|Change in waist circumference was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||cm||Standard Deviation|Mean
2546725|NCT02918279|Secondary|Change in Body Weight (%)|Relative change in body weight (kg) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Percentage change||Standard Deviation|Mean
2546726|NCT02918279|Secondary|Change in Body Weight (kg)|Change in body weight (kg) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||kg||Standard Deviation|Mean
2546727|NCT02918279|Secondary|Change in BMI|Change in BMI was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.|(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the ITT principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||kg/m^2||Standard Deviation|Mean
2546728|NCT02918279|Secondary|Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82))|Change in BMI SDS was evaluated from baseline (week 0) to weeks 30 and 82, and from week 56 to week 82. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below −3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation. Results are based on both participants who completed the trial period, week 0-30 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30 or 82, respectively.|(Week 0, week 30); (Week 0, week 82); (Week 56, week 82)|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||SDS score||Standard Deviation|Mean
2546729|NCT02918279|Secondary|Percent of Subjects Achieving ≥10% Reduction in Baseline BMI|Participants achieving more than or equal to 10% reduction in their baseline (week 0) BMI was evaluated at weeks 30, 56 and 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.|Weeks 30, 56 and 82|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Percentage of participants|||Number
2546730|NCT02918279|Secondary|Percent of Subjects Achieving ≥5% Reduction in Baseline BMI|Participants achieving more than or equal to 5% reduction in their baseline (week 0) BMI was evaluated at weeks 30, 56 and 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.|Weeks 30, 56 and 82|Results are based on the FAS which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle). “Overall Number of Participants Analyzed” = FAS. “Number Analyzed” = number of participants with available data.|||Percentage of participants|||Number
2546731|NCT02918279|Primary|Change in BMI SDS (Week 0, Week 56)|Change from baseline (week 0) in BMI SDS was evaluated at week 56. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below −3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation. Results are based on both participants who completed the week 0-56 trial period and participants who prematurely discontinued the trial product but attended the follow-up visit at 56.|Week 0, week 56|Results are based on the full analysis set (FAS) which included all randomised participants who had received at least one dose of trial product and had any post-randomisation data (according to the intention-to-treat [ITT] principle). “Overall Number of Participants Analyzed” = number of participants with available data.|||SDS score||Standard Deviation|Mean
2546732|NCT02918266|Secondary|T1/2z: Terminal Disposition Phase Elimination Half-Life in Plasma for TAK-071||Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose|The PK set included all participants who received study drug and had at least 1 measurable plasma concentration. No data was collected for Part 2 due to premature study termination because of indication change.|||hours||Standard Deviation|Mean
2546733|NCT02918266|Secondary|AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071||Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose|The PK set included all participants who received study drug and had at least 1 measurable plasma concentration. No data was collected for Part 2 due to premature study termination because of indication change.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2546734|NCT02918266|Secondary|AUCt1-t2: Area Under the Plasma Concentration-Time Curve From Time t1 to Time t2 for TAK-071||Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose|As per change in planned analyses, data was not collected.||||||
2546735|NCT02918266|Secondary|AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Postdose for TAK-071||Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 24 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 24 hours) post-scopolamine dose|The PK set included all participants who received study drug and had at least 1 measurable plasma concentration. No data was collected for Part 2 due to premature study termination because of indication change.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2546736|NCT02918266|Secondary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-071||Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose|The PK set included all participants who received study drug and had at least 1 measurable plasma concentration.No data was collected for Part 2 due to premature study termination because of indication change.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2546737|NCT02918266|Secondary|Tmax: Time to Reach the Maximum Observed Plasma Concentration(Cmax) for TAK-071||Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose|The PK set included all participants who received study drug and had at least 1 measurable plasma concentration. No data was collected for Part 2 due to premature study termination because of indication change.|||hours||Full Range|Median
2546738|NCT02918266|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-071||Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose|The pharmacokinetic (PK) set included all participants who received study drug and had at least 1 measurable plasma concentration. No data was collected for Part 2 due to premature study termination because of indication change.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2546739|NCT02918266|Secondary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Electrocardiogram (ECG) at Least Once Postdose||Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1|The safety analysis set included all participants who were enrolled and received 1 dose of study drug.|||percentage of participants|||Number
2546740|NCT02918266|Secondary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Postdose||Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1|The safety analysis set included all participants who were enrolled and received 1 dose of study drug.|||percentage of participants|||Number
2546741|NCT02918266|Secondary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Postdose||Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1|The safety analysis set included all participants who were enrolled and received 1 dose of study drug.|||percentage of participants|||Number
2546742|NCT02918266|Secondary|Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)||Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1|The safety analysis set included all participants who were enrolled and received 1 dose of study drug.|||percentage of participants|||Number
2546743|NCT02918266|Secondary|Part 2: TEmax: Time to Reach GMLT Emax for TAK-071||Day 2 pre-dose and at multiple timepoints (up to 10 hours) post-scopolamine dose|No data was collected for Part 2 due to premature study termination because of indication change.||||||
2546744|NCT02918266|Secondary|Part 2: Emax: GMLT Maximum Observed Effect (Emax) for TAK-071||Day 2 pre-dose and at multiple time points (up to 10 hours) post-scopolamine dose|No data was collected for Part 2 due to premature study termination because of indication change.||||||
2546745|NCT02918266|Secondary|Part 2: AUECt: GMLT Area Under the Effect Curve From Time 0 Hours to Time t (AUECt) (Net Area) for TAK-071||Day 2 pre-dose and at multiple time points (up to 10 hours) post-scopolamine dose|No data was collected for Part 2 due to premature study termination because of indication change.||||||
2546746|NCT02918266|Secondary|Part 2: Change From Baseline in Total Number of Errors on the GMLT||Baseline, Day 2 at multiple time points post-scopolamine dose (up to 10 hours)|No data was collected for Part 2 due to premature study termination because of indication change.||||||
2546747|NCT02918266|Primary|Part 2: Change From Baseline in Total Number of Errors on the Groton Maze Learning Test (GMLT) at 2 Hours Post-Scopolamine Dose on Day 2||Baseline, 2 hours post scopolamine dose on Day 2|No data was collected for Part 2 due to premature study termination because of indication change.||||||
2546748|NCT02918071|Secondary|The Immunogenicity of Benralizumab in the Terms of Anti-drug Antibodies (ADA)|Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive|Baseline until Week 28|Full analysis set - all patients who were administered for at least one dose of Benralizumab.|||Participants|||Number
2546749|NCT02918071|Secondary|The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels|Blood eosinophil counts by timepoint|Baseline, Week 20, and Week 28|Full analysis set - all patients who were administered for at least one dose of Benralizumab.|||cells/ uL||Inter-Quartile Range|Median
2560603|NCT02662569|Secondary|Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2546750|NCT02918071|Secondary|The Pharmacokinetics (PK) of Benralizumab in the Terms of PK Parameters: Serum Concentration of Benralizumab|Mean PK Concentration at each visit|Baseline, Week 8, Week 20, and Week 28|PK analysis set - include all patients who had at least one quantifiable serum PK observation post first dose of Benralizumab.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2546751|NCT02918071|Secondary|Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score|The effect of benralizumab on asthma control metrics in terms of change from baseline in mean Asthma Control Questionnaire-6 (ACQ-6) score. ACQ-6 score is defined as the average of the first 6 items of the ACQ questionnaire on symptoms, activity limitations, and rescue medication. Baseline is defined as the last non-missing observation prior to the first dose of study treatment. ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Smaller score indicates better controlled asthma.|Week 0 (baseline) and weeks 4, 8, 12, 16, 20|Full analysis set - all patients who were administered for at least one dose of Benralizumab.|||Scores on a scale||Standard Deviation|Mean
2546752|NCT02918071|Primary|Number of AI Devices Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints)|Number (%) of AI used to administer benralizumab at home or in the clinic and have been reported as malfunctioning (Product Complaints). The percentage is calculated based on AI dispensed for patients who were treated for the specific time point. This excludes AIs dispensed but never used for the treatment or the device not returned for evaluation.|Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16|Number of Units analyzed per row represents number of auto-injector used at each time point.|||Auto-injector|Auto-injector||Count of Units
2546753|NCT02918071|Primary|Number of Returned AI Devices Used to Administer Benralizumab at Home That Have Been Evaluated as Functional|AI evaluated as functional is defined as the device having adequately passed the visual inspection and function tests.|Week 12, Week 16|Full analysis set - all patients who were administered for at least one dose of Benralizumab.|||Auto-injector|Auto-injector||Count of Units
2546754|NCT02918071|Primary|Number of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an AI Device at Home|"Patients who are still in the study is defined as patients who had been treated for the specified timepoint. A successful administration is defined as an injection completed, an answer of Yes to all 5 questions in the Questionnaire, and adequately passed the visual inspection and function tests."|Week 12, Week 16, Week 12 and 16|Full analysis set - all patients who were administered for at least one dose of Benralizumab.|||Participants|||Count of Participants
2546755|NCT02917642|Secondary|Endotoxin Levels|Quantitative data of endotoxin levels determined by the quantitative kinetic turbidimetric LAL assay|Through study completion, an average of 2 years||||EU/mL||Full Range|Median
2546756|NCT02917642|Primary|Bacterial Levels|Quantitative data of total bacterial counts determined by a DNA-based qPCR (quantitative polymerase chain reaction) assay|Through study completion, an average of 2 years||||DNA copies||Full Range|Median
2546757|NCT02917603|Secondary|Caregiver Quality of Life|4 questions pertaining to family quality of life. There are 4 items each scored 0-9 with a total score of 0 to 36 and higher scores representing poorer quality of life.|30 days||||units on a scale||Standard Deviation|Mean
2546758|NCT02917603|Secondary|Generalized Anxiety- 7|7 questions that measure family member anxiety. It has 7 items and is scored 0-21 with a higher number representing greater anxiety. A total score is computed.|30 days||||score on a scale||Standard Deviation|Mean
2546759|NCT02917603|Secondary|Zarit Burden Interview|Family members will report which of their responsibilities are perceived as burdensome. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden. Total score computed with an average score response.|30 days||||units on a scale||Standard Deviation|Mean
2546760|NCT02917603|Primary|Difference in Mean Patient Health Questionaire 9 Score From Baseline|9 questions that indicate depression- taken at 30 days-Scale is 0-27 with higher values representing more depression. Measure collected every 30 days. Analysis is a comparison of means between the last measure taken and the baseline scores- with an overall average then computed.|30 days||||units on a scale||Standard Deviation|Mean
2546761|NCT02917265|Other Pre-specified|Percentage of Participants on Active vs Sham tVNS With Improvement in Quality of Life Measured by the Lupus QoL|The Lupus QoL is a patient reported outcome developed for measurement of quality of life of patients with SLE in clinical research|12 weeks|Analysis not done.||||||
2546762|NCT02917265|Other Pre-specified|Percentage of Participants on Active vs Sham tVNS That Experience an SLE Flare by SELENA SLEDAI Flare Index|The SELENA SLEDAI flare index captures flares in the preceding 30 days by a combination of clinical descriptors and medications rules.|12 weeks|Analysis has not been done.||||||
2546763|NCT02917265|Secondary|Percentage of Participants on Active vs Sham tVNS With Improvement in Heart Rate Variability (HRV)|HRV is measured by time domain (RMSSD and pNN50) and frequency domain [high frequency (HF), low to high frequency (LF/HF) ratio] parameters.|12 weeks|Analysis not done.||||||
2546764|NCT02917265|Secondary|Percentage of Participants on Active vs Sham tVNS With Improvement in SLE Disease Activity by the Systemic Lupus Erythematosus Responder Index (SRI-4)|"SRI requires meeting all of the following parameters:~≥4-point reduction from baseline in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score~No single new British Isles Lupus Assessment Group (BILAG) A score & not >1 new BILAG B scores AND no worsening in the Physician Global Assessment (PGA) (<10% worsening from baseline)~No initiation of non-protocol treatments or premature study discontinuation~The range of values for the above instruments are listed below, with higher scores indicating more active disease:~BILAG: 0 to 96 SLEDAI: 0 to 108 PGA: 0-3"|12 weeks|all patients randomized to active treatment or placebo that had a total SLEDAI score of at least 4 at baseline.|||Participants|||Count of Participants
2546776|NCT02916745|Secondary|Safety: Physical Examination Summaries for Each Subject|Safety evaluation will include the physical examinations summary of non-normal findings for each subject.|Up to 6 months||||Participants|||Count of Participants
2546777|NCT02916745|Secondary|Number of Subjects With at Least One Serious Adverse Event|The number of subjects with at least one serious adverse event are listed.|Up to 6 months||||Participants|||Count of Participants
2560604|NCT02662569|Secondary|Percentage of Participants With LDL-C Less Than 70 mg/dL (1.8 mmol/L) at Week 12||Week 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2546765|NCT02917265|Primary|Percentage of Participants on Active vs Sham tVNS With Improvement in SLE Disease Activity by the BILAG-based Combined Lupus Assessment (BICLA)|"Achieving a BICLA response requires to meet all of the following parameters:~All British Isles Lupus Assessment Group (BILAG) A scores improving to B/C/D and all BILAG level B scores improving to C/D~No single new BILAG A & not >1 new BILAG B scores, no worsening of the baseline Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score AND no worsening in the Physician Global Assessment (PGA) (<10% worsening from baseline)~No initiation of non-protocol treatments or premature study discontinuation~The range of values for the above instruments are listed below, with higher scores indicating more active disease:~BILAG: 0 to 96 SLEDAI: 0 to 105 PGA: 0-3"|12 weeks||||Participants|||Count of Participants
2546766|NCT02916927|Secondary|Reduction in Pain on Numeric Rating Scale.|"The difference in pain numeric rating score (NRS 0-10) experienced by participants in each arm of the study at 5, 10, 15, 20, 30, 45, and 60 minutes.~Pain numeric rating scale from 0 (no pain) to 10 (maximal pain)."|5, 10 , 15, 20, 30, 45, 60 minutes|"One patient in the Ketamine IV push arm was in radiology for the 45 and 60 minute time points.~There are 30 rather than 31 participants in the ketamine IV infusion arm because one participant withdrew before the first time point."|||score on a scale||95% Confidence Interval|Mean
2546767|NCT02916927|Secondary|How Bothersome Are the Side Effects?|"The difference in how bothersome (0, not bothersome, to 4, very bothersome, on the Side Effect Rating Scale for Dissociative Anesthetics SERSDA) the side effects experienced by participants in each arm of the study are at 5, 10, 15, 20, 30, 45, and 60 minutes.~0 (no side effects), 1 (weak), 2 (moderate), 3 (bothersome) to 4 (very bothersome)"|5, 10, 15, 20, 30, 45, 60 minutes|"One patient in the Ketamine IV push arm was in radiology for the 45 and 60 minute time points.~There are 30 rather than 31 participants in the ketamine IV infusion arm because one participant withdrew before the first time point."|||score on a scale||95% Confidence Interval|Mean
2546768|NCT02916927|Secondary|Side Effect Severity|The difference in severity of side effects (0 - 4) experienced by participants in each arm of the study at 5, 10, 15, 20, 30, 45, and 60 minutes. 0 indicates no side effects and 4 most severe side effects.|5, 10, 15, 20, 30, 45, 60 minutes|"One patient in the Ketamine IV push arm was in radiology for the 45 and 60 minute time points.~There are 30 rather than 31 participants in the ketamine IV infusion arm because one participant withdrew before the first time point."|||units on a scale||95% Confidence Interval|Mean
2546769|NCT02916927|Secondary|Side Effects|The difference in percentage of participants endorsing side effects between each arm of the study at 5, 10, 15, 20, 30, 45, and 60 minutes.|5, 10, 15, 20, 30, 45, 60 minutes|"1 patient in the Ketamine IV push arm was in radiology for the 45 and 60 minute time points.~There are 30 rather than 31 participants in the ketamine IV infusion arm because one participant withdrew before the first time point."|||participants|||Number
2546770|NCT02916927|Primary|Side Effects|The difference in percentage of participants endorsing side effects between each arm of the study over 60 minutes.|0 - 60 minutes|There are 30 rather than 31 participants in the ketamine IV infusion arm because one participant withdrew before the first time point.|||Participants|||Count of Participants
2546771|NCT02916745|Other Pre-specified|Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event|Adverse Event of special interest was Skin Photosensitivity. Skin photosensitivity was examined because all subjects who receive Photofrin are photosensitive and must observe precautions to avoid exposure of eyes and skin to direct sunlight or bright indoor lights for 30 days or longer. Changes in skin will be assessed by grade of erythema, edema and blistering and will be tabulated by Common Terminology Criteria for Adverse Events (CTCAE) grade in the dermatology/skin category.|Up to 6 months||||Participants|||Count of Participants
2546772|NCT02916745|Other Pre-specified|Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.|"Distribution of lymphocyte subsets from peripheral blood was determined by flow cytometry. Flow cytometry is a laser-based technique used to detect and measure physical and chemical characteristics of a population of cells or particles. It allows simultaneous multi-parameter analysis of single cells.~The selected markers of interest, representative of the broader markers were: Total Thymus-cells (T-Cells), Cluster of Differentiation 4 (CD4) T cell subsets, and Cluster of Differentiation 9 (CD8) T cell subset, CD4 T Regulatory (T Reg) cells, Natural Killer Cells, Activated T cells, Myeloid-Derived Suppressor Cells (MSCDs), Monocytes. The Percent Gated and Absolute counts were analysed for each marker. Gating allows the analysis to be restricted to a specific size of cells (e.g. lymphocytes) to allow a more specific analysis. Absolute counting quantifies the total number of cells. It is recommended to look at both values to get the full picture."|Baseline, 10 days post-treatment||||Participants|||Count of Participants
2546773|NCT02916745|Secondary|Safety: Laboratory Test Summaries for Each Subject|Safety evaluation includes laboratory tests summarized for each subject with any abnormal lab results considered an Adverse Event to be listed. The investigators commented on any laboratory value outside the normal reference range. If the value was judged to be an Adverse Event, it is listed. The values analysed were: Hematology (Hemoglobin, Hematocrit, White Blood Cell, Red Blood Cell, Platelet Count, Prothrombin Time) and Chemistry (Glucose (random), Blood Urea Nitrogen, Electrolytes (sodium, potassium, chloride), Creatinine, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase, Total Bilirubin, Albumin, Total Protein)|Up to 6 months||||Participants|||Count of Participants
2546774|NCT02916745|Secondary|Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events|The treatment emergent adverse events related to PFTs are noted. Pulmonary function test measurements were: Diffusion Capacity of Lung for Carbon Monoxide (%), Expiratory Reserve Volume (mL), Forced Vital Capacity (mL), Forced Expiratory Volume in 1 second (mL), Forced Expiratory Flow 25% to 75% (L/min), Functional Residual Capacity (mL), Maximum Voluntary Ventilation (L/min), Residual Volume (mL), Peak Expiratory Flow (L/min), Slow Vital Capacity (mL), Total Lung Capacity (mL)|Up to 6 months||||Participants|||Count of Participants
2546775|NCT02916745|Secondary|Safety: Number of Participants With Indicated Vital Sign Summaries|Safety evaluation included vital sign summary for each subject. Vital signs included pulse, blood pressure, temperature and respiration rate. Only clinically relevant results, as per the investigator judgement, are included. These would be vital signs that are out of the normal range but could be considered outside enough to be clinically relevant to the subject's health.|Up to 6 months||||Participants|||Count of Participants
2546778|NCT02916745|Secondary|Number of Participants With Indicated Adverse Events|Adverse events (AEs) noted by number of participants with at least one event. An AE was defined as any untoward medical occurrence in a subject during the course of the study, regardless of causal relationship. AEs were coded using MedDRA Version 21.1|Up to 6 months post-treatment||||Participants with at least one event|||Number
2546779|NCT02916745|Secondary|Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score|6-Month measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.|Up to 6 months||||score on a scale||Standard Deviation|Mean
2546780|NCT02916745|Secondary|Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score|3-Month measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.|up to 3 months||||score on a scale||Standard Deviation|Mean
2546781|NCT02916745|Secondary|Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score|Baseline measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.|Baseline||||score on a scale||Standard Deviation|Mean
2546782|NCT02916745|Secondary|Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months|"6 month score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from not at all to very much. Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden."|Up to 6 months||||score on a scale||Standard Deviation|Mean
2546783|NCT02916745|Secondary|Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months|"3 month score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from not at all to very much. Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden."|up to 3 months||||score on a scale||Standard Deviation|Mean
2546784|NCT02916745|Secondary|Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline|"Baseline score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from not at all to very much. Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden."|Baseline||||score on a scale||Standard Deviation|Mean
2546785|NCT02916745|Secondary|Short-Form Health Survey (SF-36) Score at Study Exit (6 Month Visit)|The Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints.|Up to 6 months||||score on a scale||Standard Deviation|Median
2546786|NCT02916745|Secondary|Short-Form Health Survey (SF-36) Score at Follow-up Visit at 3 Months.|The Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints.|up to 3 months||||score on a scale||Standard Deviation|Median
2546787|NCT02916745|Secondary|Short Form Health Survey (SF-36) Score at Baseline|The Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints.|Baseline||||score on a scale||Standard Deviation|Median
2546788|NCT02916745|Secondary|Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection|Measured at 6 months. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.|Up to 6 months||||Participants|||Count of Participants
2546789|NCT02916745|Secondary|Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection|Measured at 3 months. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.|up to 3 months||||Participants|||Count of Participants
2546790|NCT02916745|Secondary|Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection)|Measured at Day 3. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.|Day 30||||Participants|||Count of Participants
2546791|NCT02916745|Secondary|Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy)|Measured at Day 3. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.|Day 3||||Participants|||Count of Participants
2546792|NCT02916745|Secondary|Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection).|Measured at Day 1 which is day of the photofrin injection. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.|1 day||||Participants|||Count of Participants
2546793|NCT02916745|Secondary|Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline.|Measured at screening to be the baseline measure. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.|up to day 0 (-14 to -1 days)||||Participants|||Count of Participants
2546794|NCT02916745|Secondary|Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT)|From the start of treatment until 6 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria|Up to 6 months||||Participants|||Count of Participants
2546795|NCT02916745|Secondary|Tumor Response at 3 Months Post Photodynamic Therapy (PDT)|From the start of treatment until 3 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria|Up to 3 months||||Participants|||Count of Participants
2546796|NCT02916745|Primary|Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)|The incidence of adverse events following navigational bronchoscopy-iPDT (interstitial-Photodynamic Therapy) will be presented as the primary safety indicator for this treatment.|Up to 6 months||||Participants|||Count of Participants
2546797|NCT02916745|Primary|Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor|Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject.|Day 3 post-treatment||||Participants|||Count of Participants
2546798|NCT02916498|Primary|Patient Preferred Field Shape|Number of participants preferring bipolar field shape and alternative field shape|42 days post randomization||||Participants|||Count of Participants
2546799|NCT02916407|Secondary|Degree of Postoperative Agitation|"Postoperative agitation will measure using Pediatric Anesthesia Emergence Delirium (PAED) scale. PAED scale is (1) The child makes eye contact with the caregiver (2) The child's action are purposeful (3) The child is aware of his/her surrounding (4) The child is restless (5) The child is inconsolable. It scores 0-4, and total maximum score is 20.~PAED score > 12 was used to determine occurence of postoperative agitation."|30 minutes|A total of 56 patients were enrolled in this study and no patient was dropped.|||units on a scale||Inter-Quartile Range|Median
2546800|NCT02916407|Primary|Extubation Time|compare the extubation time between sevoflurane and desflurane group|30 minutes|A total of 56 patients were enrolled in this study and no patient was dropped.|||seconds||Standard Deviation|Mean
2546801|NCT02915978|Secondary|Participant Global Evaluation of Study Drug|Participants provide a global evaluation of study drug on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.|Within 48 hours|All randomized participants from the Intent-to-Treat (ITT) population.|||Participants|||Count of Participants
2546805|NCT02915978|Secondary|Time (Minutes) to Meaningful Pain Relief From Time 0 (First Dose of Study Medication)|Time to perceptible and meaningful pain relief will be evaluated using the 2-stopwatch method (after the first dose only) (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.)|Within 48 hours after Time 0|All randomized participants from the Intent-to-Treat (ITT) population.|||minutes||95% Confidence Interval|Mean
2546806|NCT02915978|Secondary|Time (Minutes) to First Perceptible Pain Relief From Time 0 (First Dose of Study Medication)|Time to perceptible and meaningful pain relief will be evaluated using the 2-stopwatch method (after the first dose only) (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.)|Within 48 hours after Time 0|All randomized participants from the Intent-to-Treat (ITT) population.|||minutes||95% Confidence Interval|Mean
2546807|NCT02915978|Secondary|Time (Minutes) to Peak Pain Relief From Time 0 (First Dose of Study Medication)||Within 48 hours after Time 0|All randomized participants from the Intent-to-Treat (ITT) population.|||minutes||95% Confidence Interval|Mean
2546808|NCT02915978|Secondary|Peak Pain Relief From Time 0 (First Dose of Study Medication)|The highest level of pain relief achieved on a 5-point categorical scale where 0=none, 1=a little, 2=some, 3=a lot, 4=complete.|Within 48 hours after Time 0|All randomized participants from the Intent-to-Treat (ITT) population.|||Participants|||Count of Participants
2546809|NCT02915978|Secondary|Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)|Pain relief is determined on a 5-point categorical scale where 0=none, 1=a little, 2=some, 3=a lot, 4=complete.|2.5, 5, 15, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours, as well as immediately before each use of rescue analgesia|All randomized participants from the Intent-to-Treat (ITT) population. The number analyzed differs in the later time points for the Fentanyl groups because some participants withdrew over the course of the study.|||Participants|||Count of Participants
2546810|NCT02915978|Secondary|Time to Onset of Analgesia|Measured as time to perceptible pain relief confirmed by meaningful pain relief using the 2-stopwatch method (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.)|Within 48 hours|All randomized participants from the Intent-to-Treat (ITT) population.|||minutes||95% Confidence Interval|Mean
2546811|NCT02915978|Secondary|Total Pain Relief (TOTPAR) After Time 0|TOTPAR was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). TOTPAR scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (first dose of study drug). The TOTPAR scores are the sum of the pain relief at each time point multiplied by the duration in hours since the previous time point. Larger positive numbers indicate more pain relief (maximum=4 at each time point) and smaller positive numbers indicate less pain relief (minimum=0 at each time point). The overall minimum is 0 for each variable and the overall maximum is 4 times the number of hours specified for the variable: TOTPAR-4=(0 to 16), TOTPAR-8=(0 to 32), TOTPAR-24=(0 to 96) and TOTPAR-48=(0 to 192). TOTPAR-4, TOTPAR-8, TOTPAR-24 and TOTPAR-48 were analyzed using an ANCOVA model with factors for treatment, site and baseline pain intensity.|Over 0 to 4 hours (TOTPAR-4), over 0 to 8 hours (TOTPAR-8), over 0 to 24 hours (TOTPAR-24), and over 0 to 48 hours (TOTPAR-48)|All randomized participants from the Intent-to-Treat (ITT) population.|||units on a scale||Standard Deviation|Mean
2546812|NCT02915978|Secondary|NRS SPID After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum(max)=10 at each timepoint], and negative numbers indicate an increase in pain [minimum(min)=-10 at each timepoint]. The overall min and max are -10 and 10 times the number of hours specified: SPID-4=(-40 to 40), SPID-8=(-80 to 80) and SPID-24=(-240 to 240). The NRS SPID-4, 8 and 24 were analyzed using an ANCOVA model which included treatment and site as main effects and Baseline pain intensity as the covariate.|Over 0 to 4 hours (NRS SPID-4), over 0 to 8 hours (NRS SPID-8), and over 0 to 24 hours (NRS SPID-24)|All randomized participants from the Intent-to-Treat (ITT) population.|||units on a scale||Standard Deviation|Mean
2546813|NCT02915978|Secondary|NRS Pain Intensity Score at Each Scheduled Time Point After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain.|Baseline, 1, 16, and 24 hours|All randomized participants from the Intent-to-Treat (ITT) population.|||units on a scale||Standard Deviation|Mean
2546814|NCT02915978|Secondary|NRS Pain Intensity Difference (NRS PID) at Each Categorical Time Point After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points after Time 0 (time of administration of the first dose of study drug). NRS PID is defined as the difference in pain at each scheduled time point relative to Baseline (PID=pain intensity at baseline - pain intensity at time point). A higher value of NRS PID score indicates a higher decrease in pain from Baseline. NRS PID is reported as the least squares mean difference.|Baseline, 1, 16, and 24 hours|All randomized participants from the Intent-to-Treat (ITT) population.|||units on a scale||Standard Deviation|Mean
2546841|NCT02915835|Secondary|Change From Baseline to Week 16 in HAQ-DI Eating|The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||score on a scale||Standard Error|Least Squares Mean
2546815|NCT02915978|Primary|Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours (NRS SPID-48) After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum(max)=10 at each time point], and negative numbers indicate an increase in pain [minimum(min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.|Over 0 to 48 hours after Time 0|All randomized participants from the Intent-to-Treat (ITT) population.|||units on a scale||Standard Deviation|Mean
2546816|NCT02915874|Secondary|State-Trait Anxiety Inventory (STAI) - Trait Anxiety|Self-reported anxiety measure. STAI-Form Y2 total score. Consists of 20 questions based on a 4-point Likert scale. Range of total score is 20 to 80. Higher scores indicate greater anxiety.|Baseline, 6 weeks and 12 weeks|Subjects dropped out of study|||score on a scale||Standard Deviation|Mean
2546817|NCT02915874|Secondary|Muscle Sympathetic Nerve Activity|Muscle sympathetic nerve activity will be measured directly through the peroneal nerve over a 30 minute recording. The processed signal for neural activity will be processed as bursts/minute. Data was collected for the last 3 cohorts.|Baseline, 6 weeks and 12 weeks|Last 3 cohorts were measured. Furthermore measurements are missing at random.|||bursts/minute||Standard Deviation|Mean
2546818|NCT02915874|Secondary|Forearm Blood Flow|Forearm volume (FAV). Peak Forearm blood flow was assessed by plethysmography (mL/100 mL FAV/min).|Baseline and 12 weeks|Subjects dropped out of study and some measurements are missing at random.|||mL/100 mL FAV/min||Standard Deviation|Mean
2546819|NCT02915874|Secondary|Pulse Wave Velocity (PWV)|Carotid-Femoral PWV (cm/sec)|Baseline and 12 weeks|Subjects dropped out. There are additional measurements which are missing at random.|||cm/sec||Standard Deviation|Mean
2546820|NCT02915874|Secondary|Flow-mediated Dilation of the Brachial Artery|Flow-mediated dilation of the brachial artery will be assessed by ultrasound following a 5 minute distal occlusion. Larger values are better. Data was collected for the first 5 cohorts.|Baseline and 12 weeks|Data was collected for the first 5 cohorts.|||percentage of flow-mediation dilation||Standard Deviation|Mean
2546821|NCT02915874|Secondary|State-Trait Anxiety Inventory (STAI) - State Anxiety|Self-reported anxiety measures. STAI-Form Y-1 total score. Consists of 20 questions based on a 4-point Likert scale. Range of total score is 20 to 80. Higher scores indicate greater anxiety.|Baseline, 6 weeks and 12 weeks|Subjects dropped out.|||score on a scale||Standard Deviation|Mean
2546822|NCT02915874|Primary|Beck Anxiety Inventory (BAI)|Self-report measure of anxiety. The test consists of 21 questions graded on a scale of 0 (not at all) to 3 (severely). Range of total score is 0 to 63. Higher scores indicate more severe anxiety symptoms.|Baseline, 6 weeks and 12 weeks|Subjects dropped out of study|||score on a scale||Standard Deviation|Mean
2546823|NCT02915835|Secondary|Change From Baseline to Week 16 in Vascular Biomarker ICAM in the Plasma||Baseline and Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||ng/ml||Standard Error|Least Squares Mean
2546824|NCT02915835|Secondary|Change From Baseline to Week 16 in Vascular Biomarker VCAM-1 in the Plasma||Baseline and Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||ng/ml||Standard Error|Least Squares Mean
2546825|NCT02915835|Secondary|Change From Baseline to Week 16 in Vascular Biomarker BFGF in the Plasma||Baseline and Week 16||||pg/ml||Standard Error|Least Squares Mean
2546826|NCT02915835|Secondary|Change From Baseline to Week 16 in Vascular Biomarker sE-Selectin in the Plasma||Baseline and Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||ng/ml||Standard Error|Least Squares Mean
2546827|NCT02915835|Secondary|Change From Baseline to Week 16 in Vascular Biomarker tPA in the Plasma||Baseline and Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||ng/ml||Standard Error|Least Squares Mean
2546828|NCT02915835|Secondary|Change From Baseline to Week 16 in Vascular Biomarker VEGF in the Plasma||Baseline and Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||pg/ml||Standard Error|Least Squares Mean
2546829|NCT02915835|Secondary|Proportion of Participants Who Develop Osteomyelitis During The Trial|The proportion of participants who developed osteomyelitis during the double-blind period of the trial. Osteomyelitis is collected as an Adverse Event.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2546830|NCT02915835|Secondary|Proportion of Participants Who Experience Digital Ischemia Requiring Intravenous Prostacyclin or Digital Gangrene or Amputation During the Trial.|The proportion of participants who experience digital ischemia requiring intravenous prostacyclin or digital gangrene or amputation during the double-blind period of the trial. These outcomes are collected within Adverse Events|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2546842|NCT02915835|Secondary|Change From Baseline to Week 16 in HAQ-DI Reach|The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||score on a scale||Standard Error|Least Squares Mean
2546831|NCT02915835|Secondary|Change From Baseline to Week 16 in Scleroderma-HAQ-DI Visual Analogue Scales (VAS) Assessing Overall Disease,|Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for disease severity ranges from 0 (no disease) to 150 (very severe). A higher score means a worse outcome.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||score on a scale||Standard Error|Least Squares Mean
2546832|NCT02915835|Secondary|Change From Baseline to Week 16 in Scleroderma-HAQ-DI Visual Analogue Scales (VAS) Assessing Breathing|Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much breathing problems interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||score on a scale||Standard Error|Least Squares Mean
2546833|NCT02915835|Secondary|Change From Baseline to Week 16 in Scleroderma-HAQ-DI Visual Analogue Scales (VAS) Assessing Gastrointestinal Involvement|Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much intestinal problems interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment|||score on a scale||Standard Error|Least Squares Mean
2546834|NCT02915835|Secondary|Change From Baseline to Week 16 in Scleroderma-HAQ-DI Visual Analogue Scales (VAS) Assessing Raynaud's Disease|Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much Raynaud's interfered with daily activities ranges from 0 (does not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||score on a scale||Standard Error|Least Squares Mean
2546835|NCT02915835|Secondary|Change From Baseline to Week 16 in Scleroderma-HAQ-DI Visual Analogue Scales (VAS) Assessing Burden of Digital Ulcers|Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much finger ulcers interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||score on a scale||Standard Error|Least Squares Mean
2546836|NCT02915835|Secondary|Change From Baseline to Week 16 in Total Hand Disability in Systemic Sclerosis-DU (HDISS-DU) Score|The Hand Disability in Systemic Sclerosis - Digital Ulcers (HDISS-DU) questionnaire is a 24-item PRO measure. Each item is scored from 1-6 (1=yes, without difficulty; 2=yes, with a little difficulty; 3=yes, with some difficulty; 4=yes with much difficulty; 5=nearly impossible to do & used unaffected hand only; 6=impossible). The total HDISS-DU score is the mean of valid items, ranging from 1 to 6. Higher scores represent increased disability in hand functioning.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||score on a scale||Standard Error|Least Squares Mean
2546837|NCT02915835|Secondary|Change From Baseline to Week 16 in HAQ-DI Composite Score for Hand Function|The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability).The sum of the individual scores for dressing, hygiene, and grip from the HAQ-DI defines the composite score for hand function. The HAQ-DI composite score for hand function ranges from 0 (no disability) to 9 (severe disability). A higher score means worse outcome.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||score on a scale||Standard Error|Least Squares Mean
2546838|NCT02915835|Secondary|Change From Baseline to Week 16 in HAQ-DI Common Daily Activities (IADL).|The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||score on a scale||Standard Error|Least Squares Mean
2546839|NCT02915835|Secondary|Change From Baseline to Week 16 in HAQ-DI Walking|The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||score on a scale||Standard Error|Least Squares Mean
2546840|NCT02915835|Secondary|Change From Baseline to Week 16 in HAQ-DI Grip|The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||score on a scale||Standard Error|Least Squares Mean
2546948|NCT02915159|Secondary|Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population|"The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.~CRP: measured lab value~Positive Number = Increased level of CRP Negative Number = Reduced Level of CRP"|Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|Modified intent to treat (ITT)|||mg/L||95% Confidence Interval|Mean
2546843|NCT02915835|Secondary|Change From Baseline to Week 16 in HAQ-DI Arising|The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||score on a scale||Standard Error|Least Squares Mean
2546844|NCT02915835|Secondary|Change From Baseline to Week 16 in HAQ-DI Hygiene|The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||score on a scale||Standard Error|Least Squares Mean
2546845|NCT02915835|Secondary|Change From Baseline to Week 16 in HAQ-DI Dressing and Grooming|The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||score on a scale||Standard Error|Least Squares Mean
2546846|NCT02915835|Secondary|Change From Baseline to Week 16 in Overall HAQ-DI Score|The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI overall score ranges from 0 (no disability) to 3 (severe disability). Higher score means worse outcome.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||score on a scale||Standard Error|Least Squares Mean
2546847|NCT02915835|Secondary|Change From Baseline to Week 16 in PROMIS-29 Pain Intensity|The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the pain intensity domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||t-score||Standard Error|Least Squares Mean
2546848|NCT02915835|Secondary|Change From Baseline to Week 16 in PROMIS-29 Ability to Participate in Social Roles and Activities|The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the ability to participate in social roles and activities domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||t-score||Standard Error|Least Squares Mean
2546849|NCT02915835|Secondary|Change From Baseline to Week 16 in PROMIS-29 Pain Interference|The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the pain interference domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||t-score||Standard Error|Least Squares Mean
2546850|NCT02915835|Secondary|Change From Baseline to Week 16 in PROMIS-29 Sleep Disturbance|The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the sleep disturbance domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e.,worse outcome).|Baseline/Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||t-score||Standard Error|Least Squares Mean
2546851|NCT02915835|Secondary|Change From Baseline to Week 16 in PROMIS-29 Fatigue|The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the fatigue domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||t-score||Standard Error|Least Squares Mean
2546852|NCT02915835|Secondary|Change From Baseline to Week 16 in PROMIS-29 Depression|The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the depression domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||t-score||Standard Error|Least Squares Mean
2546853|NCT02915835|Secondary|Change From Baseline to Week 16 in PROMIS-29 Anxiety|The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the anxiety domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).y.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||t-score||Standard Error|Least Squares Mean
2546854|NCT02915835|Secondary|Change From Baseline to Week 16 in PROMIS-29 Physical Function|The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the physical function domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).|Baseline/Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||t-score||Standard Error|Least Squares Mean
2546855|NCT02915835|Secondary|Change From Baseline to Week 16 in Physician's Global Assessment for Overall Disease.|This assessment represents the physician's assessment of the patient's current disease activity on a 0 (excellent) -10 (extremely poor) Likert scale. A higher score means a worse outcome.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2546856|NCT02915835|Secondary|Change From Baseline to Week 16 in Patient's Global Assessment for Overall Disease.|This assessment represents the patient's assessment of the patient's global scleroderma on a 0 (excellent) -10 (extremely poor) Likert scale. A higher score means a worse outcome.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2546857|NCT02915835|Secondary|Change From Baseline to Week 16 in Patient's Assessment of Severity of Digital Ulcers|The severity of digital ulcers, as assessed by the patient, ranges from 0 (not at all severe) to 10 (extremely severe). A higher score means a worse outcome.|Baseline to Week 16|Severity of digital ulcer(s) is calculated as the mean response on a 0-10 Likert scale.|||units on a scale||Standard Error|Least Squares Mean
2546858|NCT02915835|Secondary|Change From Baseline to Week 16 in Patient's Assessment of Severity of Raynaud's Disease|The severity of Raynaud's phenomenon, as assessed by the patient, ranges from 0 (not at all severe) to 10 (extremely severe). A higher score means a worse outcome.|Baseline to Week 16|Severity of Raynaud’s disease is calculated as the mean response on a 0-10 Likert scale.|||units on a scale||Standard Error|Least Squares Mean
2546859|NCT02915835|Secondary|Change From Baseline to Week 16 in Physician's Assessment of Severity of Digital Ulcers|The severity of digital ulcers, as assessed by the physician, ranges from 0 (not at all severe) to 10 (extremely severe). A higher score means a worse outcome.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2546860|NCT02915835|Secondary|Change From Baseline to Week 16 in Physician's Assessment of Severity of Raynaud's Disease|The severity of Raynaud's phenomenon, as assessed by the physician, ranges from 0 (not at all severe) to 10 (extremely severe). A higher score means a worse outcome.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2546861|NCT02915835|Secondary|Change From Baseline to Week 16 in Patient's Assessment of Tingling During a Raynaud's Attack|Tingling because of Raynaud's disease (characterized as tingling during a Raynaud's attack) is defined on a visual analogue scale, where 0 indicates no tingling and 100 indicates very severe tingling. A higher score means a worse outcome. The mean of the scales over a 7-day period are reported. For the days when a participant does not have an attack, a score of 0 will be used. The mean scale score for each symptom will be calculated across the 7-day screening and week 16 periods for each participant.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2546862|NCT02915835|Secondary|Change From Baseline to Week 16 in Patient's Assessment of Numbness During a Raynaud's Attack|Numbness because of Raynaud's disease (characterized as numbness during a Raynaud's attack) is defined on a visual analogue scale, where 0 indicates no numbness and 100 indicates very severe numbness. A higher score means a worse outcome. The mean of the scales over a 7-day period are reported. For the days when a participant does not have an attack, a score of 0 will be used. The mean scale score for each symptom will be calculated across the 7-day screening and week 16 periods for each participant.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2546863|NCT02915835|Secondary|Change From Baseline to Week 16 in Patient's Assessment of Pain During a Raynaud's Attack|Pain because of Raynaud's disease (characterized as pain during a Raynaud's attack) is defined on a visual analogue scale, where 0 indicates no pain and 100 indicates very severe pain. A higher score means a worse outcome. The mean of the scales over a 7-day period are reported. For the days when a participant does not have an attack, a score of 0 will be used. The mean scale score for each symptom will be calculated across the 7-day screening and week 16 periods for each participant.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2546864|NCT02915835|Secondary|Change From Baseline to Week 16 in Duration of Raynaud's Attacks|The mean duration of attacks (in minutes) will be calculated across the 7-day screening and week 16 periods for each participant. For the days when a participant does not have an attack, a score of 0 will be used.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||minutes||Standard Error|Least Squares Mean
2546865|NCT02915835|Secondary|Change From Baseline to Week 16 in Number of Raynaud's Attacks/Day|The mean number of Raynaud's attacks each day will be calculated across the 7-day screening and week 16 periods for each participant. For the days when a participant does not have an attack, a score of 0 will be used.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||attacks per day||Standard Error|Least Squares Mean
2546866|NCT02915835|Secondary|Change From Baseline to Week 16 in Raynaud's Condition Score|The Raynaud's condition score is a daily patient assessment of Raynaud's phenomenon activity using a 0 -10 ordinal scale. It incorporates the cumulative frequency, duration, severity and impact of Raynaud's phenomenon attacks, reflecting the overall degree that Raynaud's has affected use of the participant's hands. A score of 0 indicates no difficulty and 10 indicates extreme difficulty with Raynaud's condition. A higher score means a worse outcome. The mean score will be calculated across the 7-day screening and week 16 periods for each participant.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2546867|NCT02915835|Secondary|Time to Development of New ('Active' or 'Indeterminate') DU|This is defined as the number of weeks from randomization to the earliest of new DU, end of the double-blind period, or drop-out. Participants are censored if they drop-out or have not developed a new DU by the end of the double-blind period. Active ulcers are defined as having a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity. A healed ulcer has complete re-epithelialization. Week 16 is defined as the end of the double-blind period; however, the protocol allowed a visit window of +/- 4 weeks.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||weeks||Inter-Quartile Range|Median
2546868|NCT02915835|Secondary|Time to Healing of All Baseline DU|This is defined as the number of weeks from randomization to the earliest of all baseline DU(s) healed, end of the double-blind period, or drop-out. Participants are censored if they drop-out or all of their baseline DU(s) have not healed by the end of the double-blind period. A healed ulcer has complete re-epithelialization. Week 16 is defined as the end of the double-blind period; however, the protocol allowed a visit window of +/- 4 weeks.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||weeks||Inter-Quartile Range|Median
2546869|NCT02915835|Secondary|Time to Healing of Cardinal DU|This is defined as the number of weeks from randomization to the earliest of healing, end of the double-blind period, or drop-out. Participants are censored if they drop-out or their cardinal DU has not healed by the end of the double-blind period. One active digital ulcer must be identified and designated by the investigator as the cardinal ulcer at Baseline. If several digital ulcers qualified, the cardinal ulcer could be either the largest or the most painful ulcer, or the ulcer that disturbed the patient the most. The cardinal ulcer will be selected by the investigator based on the clinical judgment that it was amenable to and evaluable for healing. Active ulcers are defined as having a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. Week 16 is defined as the end of the double-blind period; however, the protocol allowed a visit window of +/- 4 weeks.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||weeks||Inter-Quartile Range|Median
2546870|NCT02915835|Secondary|Proportion of Participants With Healing of All Pressure Ulcers at the Elbows Over the Course of the Double-blind Period.|The proportion of participants whose pressure ulcers at the elbows during the double-blind period were healed at Week 16. Pressure ulcer is defined as an active or indeterminate ulcer. An active ulcer is defined as a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2546871|NCT02915835|Secondary|Proportion of Participants With Healing of All Pressure Ulcers at the Metacarpophalangeal (MCPs) Over the Course of the Double-blind Period.|The proportion of participants whose MCP pressure ulcers during the double-blind period were healed at Week 16. Pressure ulcer is defined as an active or indeterminate ulcer. An active ulcer is defined as a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2546872|NCT02915835|Secondary|Proportion of Participants With Healing of All Pressure Ulcers at the Proximal Interphalangeal (PIP) Over the Course of the Double-blind Period.|The proportion of participants whose PIP pressure ulcers during the double-blind period were healed at Week 16. Pressure ulcer is defined as an active or indeterminate ulcer. An active ulcer is defined as a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2546873|NCT02915835|Secondary|Proportion of Participants With Healing of All Pressure Ulcers at the Distal Interphalangeal (DIP) Over the Course of the Double-blind Period.|The proportion of participants whose DIP pressure ulcers during the double-blind period were healed at Week 16. Pressure ulcer is defined as an active or indeterminate ulcer. An active ulcer is defined as a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2546949|NCT02915159|Secondary|Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population|"The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.~Tender Joint: Count 1-28 Swollen Joint: Count 1-28~Negative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted"|Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|Modified intent to treat (ITT)|||Joint Count||95% Confidence Interval|Mean
2546874|NCT02915835|Secondary|Proportion of Participants Who Develop Pressure Ulcers at the Elbows Over the Course of the Double-blind Period.|The proportion of participants who develop a pressure ulcer at at the elbows at baseline to Week 16. Pressure ulcer is defined as an active or indeterminate ulcer. An active ulcer is defined as a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2546875|NCT02915835|Secondary|Proportion of Participants Who Develop Pressure Ulcers at Metacarpophalangeal (MCPs) Location Over the Course of the Double-blind Period.|The proportion of participants who develop a MCP pressure ulcer at baseline to Week 16. Pressure ulcer is defined as an active or indeterminate ulcer. An active ulcer is defined as a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2546876|NCT02915835|Secondary|Proportion of Participants Who Develop Pressure Ulcers at Proximal Interphalangeal (PIP) Location Over the Course of the Double-blind Period.|The proportion of participants who develop a PIP pressure ulcer at baseline to Week 16. Pressure ulcer is defined as an active or indeterminate ulcer. An active ulcer is defined as a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2546877|NCT02915835|Secondary|Proportion of Participants Who Develop Pressure Ulcers at Distal Interphalangeal (DIP) Location Over the Course of the Double-blind Period.|The proportion of participants who develop a DIP pressure ulcer at baseline to Week 16. Pressure ulcer is defined as an active or indeterminate ulcer. An active ulcer is defined as a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2546878|NCT02915835|Secondary|Proportion of Participants With New Active and Indeterminate DU(s) Over the Course of the Double-blind Period|The proportion of participants with new (i.e., not present at baseline) active and indeterminant DUs from baseline to Week 16. An active ulcer is defined as a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity.|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2546879|NCT02915835|Secondary|Proportion of Participants With no DUs at Week 16|The proportion of participants with no digital ulcers at week 16. This end point does not consider the number of ulcers at baseline or during the course of the study; only the absence of 'active' and 'indeterminate' DUs at week 16. Active ulcers are defined as having a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity. A healed ulcer has complete re-epithelialization.|Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2546880|NCT02915835|Secondary|Proportion of Participants With Healing of All DUs at Baseline by Week 16|The proportion of participants whose baseline DUs are considered healed (classified as 'healed' and not 'active' or 'indeterminate') by week 16. All baseline ulcers must be healed for the participant to be classified as having all baseline ulcers healed. Note that this end point does not consider whether a participant develops new DUs during the course of the study. Active ulcers are defined as having a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity. A healed ulcer has complete re-epithelialization.|Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2546881|NCT02915835|Secondary|Proportion of Participants With Healing of Their Cardinal DU by Week 16|The proportion of participant whose active digital ulcer that was identified and designated by the investigator as the cardinal ulcer at Baseline is healed by week 16. The cardinal ulcer will be selected by the investigator based on the clinical judgment that it was amenable to and evaluable for healing. If there are several active digital ulcers, the cardinal ulcer could be either the largest or the most painful ulcer, or the ulcer that disturbed the patient the most. Active ulcers are defined as having a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis.|Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||Participants|||Count of Participants
2546882|NCT02915835|Primary|Change From Baseline to End of Double-blind Treatment (Week 16) in Digital Ulcer Net Burden|"Digital ulcer net burden is defined as the total number of active and indeterminate digital ulcers at an assessment. Active ulcers are defined as having a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity. A healed ulcer has complete re-epithelialization."|Baseline to Week 16|Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment.|||ulcers||Standard Error|Least Squares Mean
2546883|NCT02915705|Secondary|Percent of Predicted Normal in the 6MWT Total Distance at Week 64|The total distance walked (meters) in a 6-minute period was measured in participants ≥ 5 years of age at the Screening Visit who were able to complete the test, and the percent predicted distance based on normative data for age and gender was estimated.|Baseline, Week 64|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 64.|||percent of predicted meters||Standard Error|Least Squares Mean
2546884|NCT02915705|Secondary|Percent of Predicted Normal in the 6MWT Total Distance at Week 40|The total distance walked (meters) in a 6-minute period was measured in participants ≥ 5 years of age at the Screening Visit who were able to complete the test, and the percent predicted distance based on normative data for age and gender was estimated.|Baseline, Week 40|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 40.|||percent of predicted meters||Standard Error|Least Squares Mean
2546885|NCT02915705|Secondary|Change From Baseline in the 6MWT Total Distance at Week 64|The total distance walked (meters) in a 6-minute period was measured in participants ≥ 5 years of age at the Screening Visit who were able to complete the test.|Baseline, Week 64|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 64.|||meters||Standard Error|Least Squares Mean
2546886|NCT02915705|Secondary|Change From Baseline in the 6MWT Total Distance at Week 40|The total distance walked (meters) in a 6-minute period was measured in participants ≥ 5 years of age at the Screening Visit who were able to complete the test.|Baseline, Week 40|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 40 in subjects ≥ 5 years who were able to complete the test.|||meters||Standard Error|Least Squares Mean
2546887|NCT02915705|Secondary|Change From Baseline in the FPS-R (For Participants ≥ 5 Years of Age at the Screening Visit) at Week 64|The FPS-R is a dimensionless 10 point Likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.|Baseline, Week 64|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 64.|||units on a scale||Standard Error|Least Squares Mean
2546888|NCT02915705|Secondary|Change From Baseline in the FPS-R (For Participants ≥ 5 Years of Age at the Screening Visit) at Week 40|The FPS-R is a dimensionless 10 point Likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.|Baseline, Week 40|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 40.|||units on a scale||Standard Error|Least Squares Mean
2546889|NCT02915705|Secondary|Change From Baseline in the PROMIS Pediatric Pain Interference, Physical Function Mobility and Fatigue Domain Scores (For Participants ≥ 5 Years of Age at the Screening Visit) at Week 64|The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013), (NIH 2015). It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Pain Interference Domain, decreases indicate less pain, for the Physical Function Mobility Domain, increases indicate greater mobility and for the Fatigue Domain, decreases indicate less fatigue.|Baseline, Week 64|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 64.|||T-score||Standard Error|Least Squares Mean
2546890|NCT02915705|Secondary|Change From Baseline in the PROMIS Pediatric Pain Interference, Physical Function Mobility and Fatigue Domain Scores (For Participants ≥ 5 Years of Age at the Screening Visit) at Week 40|The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being (Broderick et al. 2013), (NIH 2015). It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For the Pain Interference Domain, decreases indicate less pain, for the Physical Function Mobility Domain, increases indicate greater mobility and for the Fatigue Domain, decreases indicate less fatigue.|Baseline, Week 40|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 40.|||T-score||Standard Error|Least Squares Mean
2546891|NCT02915705|Secondary|Percent Change From Baseline Over Time in Serum ALP, up to Week 112|Decreases indicate improvement.|Baseline, Weeks 16, 24, 40, 52, 64, 68, 76, 88, 100, 112|PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data.|||percent change||Standard Deviation|Mean
2546892|NCT02915705|Secondary|Change From Baseline Over Time in Serum ALP, Week 68 to 112||Baseline, Weeks 68, 76, 88, 100, 112|PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data.|||U/L||Standard Deviation|Mean
2546893|NCT02915705|Secondary|Change From Baseline Over Time in Serum ALP, up to Week 64|The GEE model includes change from baseline for ALP measurement as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline ALP measure as a covariate, with exchangeable covariance structure. The GEE model included data up to Week 64.|Baseline, Weeks 16, 24, 40, 52, 64|PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data.|||U/L||Standard Error|Least Squares Mean
2546894|NCT02915705|Secondary|Change From Baseline Over Time in TmP/GFR, Week 68 to 112|Serum phosphorus and TRP measurements were used in the calculation of TmP/GFR.|Baseline, Weeks 68, 76, 88, 112|PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data. Participants with data at given time point.|||mg/dL||Standard Deviation|Mean
2547000|NCT02914210|Secondary|Pain Score|Non-inferiority safety endpoint: pain score at 12 weeks. Measured on scale from 0 to 10, with 0 being no pain and 10 being worst pain imaginable.|12 weeks|Patients randomized and receiving eligible surgery, completing study through 12 weeks, and responding to survey question regarding pain.|||score on a scale||Standard Deviation|Mean
2546895|NCT02915705|Secondary|Change From Baseline Over Time in TmP/GFR, up to Week 64|"Serum phosphorus and TRP measurements were used in the calculation of TmP/GFR.~The GEE model includes change from baseline for TmP/GFR measurement as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline TmP/GFR measure as a covariate, with exchangeable covariance structure. The GEE model included data up to Week 64."|Baseline, Weeks 4, 8, 16, 24, 32, 40, 52, 64|PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data. Participants with an assessment at given time point.|||mg/dL||Standard Error|Least Squares Mean
2546896|NCT02915705|Secondary|Change From Baseline Over Time in 1,25-Dihydroxyvitamin D, Weeks 68 to 112||Baseline, Weeks 68, 76, 88, 100, 112|PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data. Participants with an assessment at given time point.|||pg/mL||Standard Deviation|Mean
2546897|NCT02915705|Secondary|Change From Baseline Over Time in 1,25-Dihydroxyvitamin D, up to Week 64|The GEE model includes change from baseline for 1, 25-Dihydroxyvitamin D measurement as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline 1, 25-Dihydroxyvitamin D measure as a covariate, with exchangeable covariance structure. The GEE model included data up to Week 64.|Baseline, Weeks 1, 2, 4, 8, 12, 16, 24, 32, 33, 40, 52, 64|PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data. Participants with an assessment at given time point.|||pg/mL||Standard Error|Least Squares Mean
2546898|NCT02915705|Secondary|Percentage of Participants Reaching the Normal Range of Serum Phosphorus Concentration (3.2 - 6.1 mg/dL)||Burosumab arm: Baseline, up to Week 140; Active Control arm: Baseline, Week 68 up to Week 140|PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data.|||percentage of participants|||Number
2546899|NCT02915705|Secondary|Change From Baseline in Mean Post-Baseline Serum Phosphorus Level to Week 140 (During Treatment With Burosumab)||Burosumab arm: Baseline, Week 1, 4, 8, 16, 24, 32, 40, 52, 64, 66, 68, 76, 88, 100, 112, 124, 140; Active Control arm: Baseline, Week 68, 76, 88, 100, 112, 124, 140|PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data.|||mg/dL||Standard Deviation|Mean
2546900|NCT02915705|Secondary|Change From Baseline in Mean Post-Baseline Serum Phosphorus Level to Week 64|The ANCOVA model includes change in serum phosphorus from baseline to mean post-baseline as the dependent variable, treatment group, baseline age and baseline RSS stratification as factors, baseline phosphorous measure as a covariate.|Baseline, Weeks 1, 4, 8, 16, 24, 32, 40, 52, 64|PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data.|||mg/dL||Standard Error|Least Squares Mean
2546901|NCT02915705|Secondary|Change From Baseline Over Time in Serum Phosphorus Concentration, Weeks 66-112||Baseline, Weeks 66, 68, 76, 88, 100, 112|PD Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data. Participants with an assessment at given time point.|||mg/dL||Standard Deviation|Mean
2546902|NCT02915705|Secondary|Change From Baseline Over Time in Serum Phosphorus Concentration, up to Week 64|The GEE model includes change from baseline for serum phosphorous measurement as the dependent variable, treatment group, visit, interaction between treatment group by visit, baseline age and baseline RSS stratification as factors, baseline phosphorous measure as a covariate, with exchangeable covariance structure. The GEE model included data up to Week 64.|Baseline, Weeks 1, 2, 4, 8, 12, 16, 24, 32, 33, 40, 52, 64|Pharmacodynamic (PD) Analysis Set: all participants who received at least one dose of study therapy and had evaluable serum data. Participants with data at given time point.|||mg/dL||Standard Error|Least Squares Mean
2546903|NCT02915705|Secondary|Change in Growth Velocity Z Score From Baseline to Week 64|A growth velocity Z score was calculated based on Tanner's standard. The Z score indicates the number of standard deviations away from a reference population (from Tanner's standard) in the same age range and with the same sex. The baseline growth velocity was calculated for participants who had data available from within 1.5 years prior to baseline. The Week 64 growth velocity was calculated using data between baseline and Week 64. The mid-point of the age interval was used to locate the closest reference age provided by Tanner's Standard. Children with a mid-point age under 2.25 years were excluded, because younger ages are not available in Tanner's standard. To smoothly transition from recumbent length to standing height, 0·8 cm was subtracted from recumbent length before pooling with standing height. A Z score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z scores indicate a better outcome.|Baseline, Week 64|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with Baseline growth velocity.|||Z score||Standard Error|Least Squares Mean
2546904|NCT02915705|Secondary|Change in Growth Velocity Z Score From Baseline to Week 40|A growth velocity Z score was calculated based on Tanner's standard. The Z score indicates the number of standard deviations away from a reference population (from Tanner's standard) in the same age range and with the same sex. The baseline growth velocity was calculated for participants who had data available from within 1.5 years prior to baseline. The Week 64 growth velocity was calculated using data between baseline and Week 64. The mid-point of the age interval was used to locate the closest reference age provided by Tanner's Standard. Children with a mid-point age under 2.25 years were excluded, because younger ages are not available in Tanner's standard. To smoothly transition from recumbent length to standing height, 0·8 cm was subtracted from recumbent length before pooling with standing height. A Z score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z scores indicate a better outcome.|Baseline, Week 40|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with Baseline growth velocity.|||Z score||Standard Error|Least Squares Mean
2546961|NCT02915029|Secondary|KDQOL-Symptom/Problem|Changes on study of symptom/problem list from quality of life (KDQOL-36). Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.|12 months minus baseline values||||points||Standard Deviation|Mean
2546905|NCT02915705|Secondary|Change From Baseline in Height-For-Age Z-Scores to Week 64|Recumbent length/Standing height z scores are measures of height adjusted for a child's age and sex. The Z-score indicates the number of standard deviations away from a reference population (from the CDC growth charts) in the same age range and with the same sex. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome.|Baseline, Week 64|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 64.|||Z score||Standard Error|Least Squares Mean
2546906|NCT02915705|Secondary|Change From Baseline in Height-For-Age Z-Scores to Week 40|Recumbent length/Standing height z scores are measures of height adjusted for a child's age and sex. The Z-score indicates the number of standard deviations away from a reference population (from the Centers for Disease Control [CDC] growth charts) in the same age range and with the same sex. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome.|Baseline, Week 40|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment. Participants with an assessment at Week 40.|||Z score||Standard Error|Least Squares Mean
2546907|NCT02915705|Secondary|RGI-C Long Leg Score at Week 64|Changes in the severity of lower extremity skeletal abnormalities, including genu varum and genu valgus, were assessed using a disease specific qualitative RGI-C scoring system. The RGI-C is a 7-point ordinal scale with possible values: +3 = very much better (complete or near complete healing), +2 = much better (substantial healing), +1 = minimally better (i.e., minimal healing), 0 = unchanged, -1 = minimally worse (minimal worsening), -2 = much worse (moderate worsening), -3 = very much worse (severe worsening).|Week 64|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment.|||score on a scale||Standard Error|Least Squares Mean
2546908|NCT02915705|Secondary|RGI-C Long Leg Score at Week 40|Changes in the severity of lower extremity skeletal abnormalities, including genu varum and genu valgus, were assessed using a disease specific qualitative RGI-C scoring system. The RGI-C is a 7-point ordinal scale with possible values: +3 = very much better (complete or near complete healing), +2 = much better (substantial healing), +1 = minimally better (i.e., minimal healing), 0 = unchanged, -1 = minimally worse (minimal worsening), -2 = much worse (moderate worsening), -3 = very much worse (severe worsening).|Week 40|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment.|||score on a scale||Standard Error|Least Squares Mean
2546909|NCT02915705|Secondary|Change From Baseline in RSS Total Score at Week 64|The RSS system is a 10-point radiographic scoring method that was developed to assess the severity of nutritional rickets in the wrists and knees based on the degree of metaphyseal fraying, cupping, and the proportion of the growth plate affected. Scores are assigned for the unilateral wrist and knee X-rays deemed by the rater to be the more severe of the bilateral images. The maximum total score on the RSS is 10 points and the minimum score is 0, with a total possible score of 4 points for the wrists and 6 points for the knees. Higher scores indicate greater rickets severity.|Baseline, Week 64|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline RSS Total Score assessment.|||score on a scale||Standard Error|Least Squares Mean
2546910|NCT02915705|Secondary|Change From Baseline in RSS Total Score at Week 40|The RSS system is a 10-point radiographic scoring method that was developed to assess the severity of nutritional rickets in the wrists and knees based on the degree of metaphyseal fraying, cupping, lucency, separation, and the proportion of the growth plate affected. Scores are assigned for the unilateral wrist and knee X-rays deemed by the rater to be the more severe of the bilateral images. The maximum total score on the RSS is 10 points and the minimum score is 0, with a total possible score of 4 points for the wrists and 6 points for the knees (the total score is the sum of the wrist and knee score). Higher scores indicate greater rickets severity.|Baseline, Week 40|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline RSS Total Score assessment.|||score on a scale||Standard Error|Least Squares Mean
2546911|NCT02915705|Secondary|RGI-C Global Score at Week 64|Changes in the severity of rickets and bowing were assessed using a disease specific qualitative RGI-C scoring system. The RGI-C is a 7-point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets).|Week 64|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment.|||score on a scale||Standard Error|Least Squares Mean
2546912|NCT02915705|Secondary|Percentage of Participants With a Mean RGI-C Global Score ≥ +2.0 (Responders) at Week 64|RGI-C responders are defined as participants with a mean RGI-C global score >= +2.0. The RGI-C is a 7-point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets).|Week 64|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment.|||percentage of participants|||Number
2546913|NCT02915705|Secondary|Percentage of Participants With a Mean RGI-C Global Score ≥ +2.0 (Responders) at Week 40|RGI-C responders are defined as participants with a mean RGI-C global score >= +2.0. The RGI-C is a 7-point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets).|Week 40|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment.|||percentage of participants|||Number
2546962|NCT02915029|Secondary|UACR|change in urinary albumin to creatinine ratio on study.|12 months minus baseline values||||mg/g||Inter-Quartile Range|Median
2546914|NCT02915705|Primary|Radiographic Global Impression of Change (RGI-C) Global Score at Week 40|Changes in the severity of rickets and bowing were assessed using a disease specific qualitative RGI-C scoring system. The RGI-C is a 7-point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets).|Week 40|Full Analysis Set: all randomized participants who received at least one dose of assigned medication and had at least one post-baseline assessment.|||score on a scale||Standard Error|Least Squares Mean
2546915|NCT02915302|Secondary|Percentage of Participants With Seroconversion (Seroconversion Rate [SCR]) to Influenza Vaccine Antigens|Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage. SCR was defined as percentage of participants with either a pre-vaccination titer <10 (1/dil) and a post-final vaccination titer >=40 (1/dil), or a pre-vaccination titer >=10 (1/dil) and at least a four-fold increase in post-final vaccination titer.|28 days post-final vaccination|Analysis was performed using the PP analysis set. Here, ‘Number Analyzed’ = those participants with available data for specified categories.|||percentage of participants||95% Confidence Interval|Number
2546916|NCT02915302|Secondary|Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage, B Yamagata lineage.|28 days post-final vaccination|Analysis was performed using Per-protocol (PP) analysis set which included participants who received at least 1 dose of study vaccine and had a valid post-vaccination serologic result for at least 1 strain without any protocol deviations. Here, ‘Number Analyzed’ = those participants with available data for specified categories.|||Titers (1/dilutions [dil])||95% Confidence Interval|Geometric Mean
2546917|NCT02915302|Primary|Percentage of Participants With Fever (Fever Rate) Following Vaccination With Fluzone Quadrivalent Vaccine|Fever rate was defined as percentage of participants with fever (temperature >=100.4 degrees Fahrenheit [38.0 degrees Celsius]) following vaccination with Fluzone Quadrivalent vaccine.|Within 7 days after any vaccination|Analysis was performed using the safety analysis set. Here, ‘Number of participants analyzed’ = those participants with available data for this endpoint.|||percentage of participants||95% Confidence Interval|Number
2546918|NCT02915159|Secondary|Laboratory Marked Abnormalities: Double Blind Period|Laboratory values meeting the marked abnormality criteria|Day 1 up to first dose of OL abatacept or up to 56 post last dose in double -blind for those not in OL.|As-Treated Analysis Population|||Percentage|||Number
2546919|NCT02915159|Secondary|Summary of Adverse Events: Double Blind Period|Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation|Day 1 up to first dose of Open Label Treatment Period (OLTP) abatacept or up to 56 post last dose in double -blind for those not in OL.|As-Treated Population|||Percentage|||Number
2546920|NCT02915159|Secondary|Percentage of Participants With a Positive Antibody Response|Percentage of participants with at least one positive immunogenicity response up to Day 169 and during 3 months follow up (for participants who discontinue during the 6-months double-blind).|Day 85 db, day 169 db, post treatment day 85|Immunogenicity Analysis Population|||Percentage|||Number
2546921|NCT02915159|Secondary|Geometric Mean of Trough Concentration (Cmin) of Abatacept|Geometric mean of trough concentration (Cmin) of abatacept at all measured time points.|Day 29, 85, 113, 141, 169|Pharmacokinetic (PK) Evaluable Population|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2546922|NCT02915159|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36)|"The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.~Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement"|Day 85, Day 169|Modified ITT Population|||Score on a Scale||95% Confidence Interval|Mean
2546923|NCT02915159|Secondary|Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI)|"For the FSFI, is a 19 item instrument used for assessing key dimensions of female sexual function over the past 4 weeks with 6 domains being analyzed. The specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI are scored on a scale ranging from 0 to 5, with higher scores indicating better performance. Domain scores are calculated by summing the scores of the individual questions that make up the domain and multiplying the sum by the factor in the table below. The full scale score is the sum of the six domain scores.~Full Scale Score range: 2.0(minimum score) - 36.0 (maximum score)~Negative Score = Reduced functioning Positive Score = Improved functioning"|Day 85, Day 169|Modified ITT Population|||Scores on a Scale||95% Confidence Interval|Mean
2546924|NCT02915159|Secondary|Change From Baseline in Patient Fatigue|"The mean change from baseline in patient fatigue using Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue assessment of disease activity at all measured time points up to Day 169.~PROMIS Fatigue instruments 10 Questions ranging from a score 0 to 40. Sum of the values gives you the raw sum. The raw is inputted into this formula to give you the raw score:~Raw Score = (Raw sum*number of items on the short form)/(Number of items that were actually answered)~Raw score is translated to a T-Score using a table. T-Score is used as the final score.~The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. The standardized T-score is reported as the final score for each participant.~A negative T Score = Better Prognosis A positive T Score = Worse prognosis"|Day 29, 57, 85, 113, 141, 169|Modified ITT Population|||T-Score||95% Confidence Interval|Mean
2546950|NCT02915159|Secondary|Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3|"The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm.~DAS28-CRP = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(hsCRP+1) + 0.014 * VAS + 0.96.~(sqrt = Square root, ln = natural log)~Positive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity"|Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|Modified ITT Population with Baseline Tender plus Swollen Joint Count of Less than 3|||Scores on a scale||95% Confidence Interval|Mean
2546925|NCT02915159|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity|"The physician global assessment of disease activity are assessed with visual analog scales. The physician marks a vertical line through a horizontal line, where the beginning of the horizontal line represents the best situation, and the end of the horizontal line represents the very worst situation. The CRF collects the distance in millimeters from the start of the scale that is marked as well as the length of the scale in millimeters.~In cases that the length of the scale is in less or more than 100 millimeters, then the participants measurement will be rescaled to the equivalent of 100 millimeters using the formula below:~Rescale Measurement in mm = (measurement as reported on CRF in mm/length of the line on CRF in mm) * 100mm~A negative score = physician assessment of disease activity has improved~A positive score = physician assessment of disease activity has worsened"|Day 29, 57, 85, 113, 141, 169|Modified ITT Population|||Score on VAS 0-100mm Scale||95% Confidence Interval|Mean
2546926|NCT02915159|Secondary|Change From Baseline in Participant Assessment of Disease Activity|"The participant global assessment of disease activity are assessed with visual analog scales. The participant marks a vertical line through a horizontal line, where the beginning of the horizontal line represents the best situation, and the end of the horizontal line represents the very worst situation. The CRF collects the distance in millimeters from the start of the scale that is marked as well as the length of the scale in millimeters.~In cases that the length of the scale is in less or more than 100 millimeters, then the participants measurement will be rescaled to the equivalent of 100 millimeters using the formula below:~Rescale Measurement in mm = (measurement as reported on CRF in mm/length of the line on CRF in mm) * 100mm~A negative score = participant assessment of disease activity has improved~A positive score = participant assessment of disease activity has worsened"|Day 29, 57, 85, 113, 141, 169|Modified ITT Population|||Score on VAS 0-100mm scale||95% Confidence Interval|Mean
2546927|NCT02915159|Secondary|Change From Baseline in Numeric Rating Scale for Eye Dryness|"The mean change from baseline in patient symptoms using the Numeric Rating Scale (NRS) for eye dryness at all measured time points up to Day 169.~The oral and ocular dryness are each assessed by the patients with numeric rating scales from 0 to 10 with 0 representing no dryness and 10 representing maximal dryness"|Day 1, 29, 57, 85, 113, 141, 169|Modified ITT Population|||Score on a Scale||Full Range|Mean
2546928|NCT02915159|Secondary|Change From Baseline in Numeric Rating Scale for Mouth Dryness|"The mean change from baseline in participant symptoms using the Numeric Rating Scale (NRS) for mouth dryness at all measured time points up to Day 169.~The oral and ocular dryness are each assessed by the patients with numeric rating scales from 0 to 10 with 0 representing no dryness and 10 representing maximal dryness"|Day 1, 29, 57, 85, 113, 141, 169|Modified ITT Population|||Score on a Scale||Full Range|Mean
2546929|NCT02915159|Secondary|Change From Baseline in Stimulated Salivary Flow|The mean change from baseline in Stimulated whole salivary flow at all measured time points up to Day 169.|Day 85, Day 169|Modified ITT Population|||mL/min||95% Confidence Interval|Mean
2546930|NCT02915159|Secondary|Change From Baseline in Unstimulated Salivary Flow|The mean change from baseline in unstimulated whole salivary flow at all measured time points up to Day 169.|Day 85, Day 169|Modified ITT Population|||mL/min||95% Confidence Interval|Mean
2546931|NCT02915159|Secondary|Change From Baseline in Tear Break-up Time|"The Mean change from baseline in Tear Break-up Time at all measured time points up to day 169~The CRF collects the time in seconds to first appearance of a random dry spot on the corneal surface for 3 repetitions in each eye. The average time will calculated for each eye averaging the 3 measurements for each eye separately. In case only 2 measurements are available, the average of the 2 measurements will be calculated. In case there is only 1 measurement, that measurement will be used for the analysis."|Day 85, Day 169|Modified ITT Population|||Seconds||95% Confidence Interval|Mean
2546932|NCT02915159|Secondary|Change From Baseline in the Ocular Staining Score (OSS)|"The Mean change from baseline in OSS at all measured time points up to day 169~Score of 0 = No Staining Score of 12 = diffuse staining~The total score will be calculated as the sum of the score for these parameters for each eye.~Medial Nasal Bulbar Conjunctiva (MNBC) [score scale: 0 - 3], Corneal (CORN) Staining of Punctate Epithelial Erosions (PEE) [score scale: 0 - 3], Lateral Temporal Bulbar Conjunctiva (LTBC) [score scale: 0 - 3], Patches of Confluent Staining (CONF) [score scale: 0 - 1], PEE observed in the pupil region, i.e. central 4mm diameter portion of the cornea (PUPL) [score scale: 0 - 1], one of more filaments seen anywhere on the cornea (FILA) [score scale: 0 - 1]"|Day 85, Day 169|Modified ITT Population|||Score on a Scale||95% Confidence Interval|Mean
2546933|NCT02915159|Secondary|Change From Baseline in Schirmer's Test|"The Mean change from baseline in Schirmer's Test at all measured time points up to day 169~The length in millimeters that the strip wets during the 5 minute test period for each eye. Collection is done separately for each eye."|Day 85, Day 169|Modified ITT Population|||millimeters||95% Confidence Interval|Mean
2546934|NCT02915159|Secondary|Change From Baseline in ESSPRI Components|"The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components.~Total Score Range (0 = Best outcome and 10 = Worst Outcome)~The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains."|Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|Modified ITT Population|||Score on a Scale||95% Confidence Interval|Mean
2546935|NCT02915159|Secondary|Change From Baseline in Components of ESSDAI|"The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain.~The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm.~Domain: (Score for activity level) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2)~(No = No Disease Activity, Low = Low Disease Activity, Moderate = Moderate Disease Activity, High = High Disease Activity)"|Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169|Modified ITT Population|||Score on a Scale||95% Confidence Interval|Mean
2546936|NCT02915159|Secondary|Change From Baseline at All Measured Time Points in the ESSPRI|"The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components.~Total Score Range (0 = Best outcome and 10 = Worst Outcome)~The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains."|Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|Modified intent to treat (ITT) Population|||Score on a Scale||95% Confidence Interval|Mean
2546937|NCT02915159|Secondary|Change From Baseline at All Measured Time Points in the ESSDAI|"The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain.~The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm.~Domain: (Score) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2)~(No = No Disease Activity (DA), Low = Low DA, Moderate = Moderate DA, High = High DA)~Overall score, which can range from 0 to 123, a higher score indicates more disease activity"|Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|Modified intent to treat (ITT) Population|||Percent Change from Baseline||95% Confidence Interval|Mean
2546938|NCT02915159|Secondary|Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point|Proportion of participants who achieve a minimally clinically important change (of at least 1 point) in the ESSPRI at all measured time points up to Day 169.|Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|Modified intent to treat (ITT) Population|||Percentage||95% Confidence Interval|Number
2546939|NCT02915159|Secondary|Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points|Proportion of participants who achieve a minimally clinically important change (of at least 5 points) in the ESSDAI at all measured time points up to Day 169.|Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|Modified intent to treat (ITT) Population|||Percentage||95% Confidence Interval|Number
2546940|NCT02915159|Secondary|Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points|Proportion of participants who achieve a minimally clinically important change (of at least 3 points) in the ESSDAI at all measured time points up to Day 169.|Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|Modified intent to treat (ITT) Population|||Percentage||95% Confidence Interval|Number
2546941|NCT02915159|Secondary|Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3|"The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.~Assesment of Disease Activity: 0-100 scale [100=Most severe]~Positive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity"|Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of Less than 3|||Scores on a Scale||95% Confidence Interval|Mean
2546942|NCT02915159|Secondary|Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3|"The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.~CRP: measured lab value~Positive Number = Increased level of CRP Negative Number = Reduced Level of CRP"|Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of Less than 3|||mg/L||95% Confidence Interval|Mean
2546943|NCT02915159|Secondary|Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3|"The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.~Tender Joint: Count 1-28 Swollen Joint: Count 1-28~Negative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted"|Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of Less than 3|||Joint Count||95% Confidence Interval|Mean
2546944|NCT02915159|Secondary|Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3|"The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.~Assesment of Disease Activity: 0-100 scale [100=Most severe]~Positive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity"|Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of at least 3|||Score on a Scale||95% Confidence Interval|Mean
2546945|NCT02915159|Secondary|Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3|"The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.~CRP: measured lab value~Positive Number = Increased level of CRP Negative Number = Reduced Level of CRP"|Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of at least 3|||mg/L||95% Confidence Interval|Mean
2546946|NCT02915159|Secondary|Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3|"The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.~Tender Joint: Count 1-28 Swollen Joint: Count 1-28~Negative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted"|Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|Modified intent to treat (ITT) Population with Baseline Tender plus Swollen Joint Count of at least 3|||Joint Count||95% Confidence Interval|Mean
2546947|NCT02915159|Secondary|Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population|"The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.~Assesment of Disease Activity: 0-100 scale [100=Most severe]~Positive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity"|Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|Modified intent to treat (ITT)|||Scores on a Scale||95% Confidence Interval|Mean
2546963|NCT02915029|Secondary|eGFR|Changes in estimated (via CKD-EPI) Glomerular Filtration Rate.|12 months minus baseline values||||mL/min/1.73 m2||Standard Deviation|Mean
2546951|NCT02915159|Secondary|Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3|"The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm.~DAS28-CRP = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(hsCRP+1) + 0.014 * VAS + 0.96.~(sqrt = Square root, ln = natural log)~Positive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity"|Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|Modified ITT Population with Baseline Tender plus Swollen Joint Count of at Least 3|||Scores on a scale||95% Confidence Interval|Mean
2546952|NCT02915159|Secondary|Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population|"The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm.~DAS28-CRP = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(hsCRP+1) + 0.014 * VAS + 0.96.~(sqrt = Square root, ln = natural log)~Positive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity"|Day 29, Day 57, Day 85, Day 113, Day 141, Day 169|Modified ITT Population|||Scores on a scale||95% Confidence Interval|Mean
2546953|NCT02915159|Secondary|Change From Baseline in the Stimulated Whole Salivary Flow|The mean change from baseline in the stimulated whole salivary flow at Day 169|Day 169|Modified ITT Population with Stimulated Whole Salivary Flow of at Least 0.1 mL/min at Both Screening and Baseline|||mL/min||95% Confidence Interval|Mean
2546954|NCT02915159|Secondary|Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI)|"The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components.~Total Score Range (0 = Best outcome and 10 = Worst Outcome)~The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains."|Day 169|Modified ITT Population|||Score on a Scale||95% Confidence Interval|Mean
2546955|NCT02915159|Primary|Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)|"The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain.~The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm.~Domain: (Score) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2)~(No = No Disease Activity (DA), Low = Low DA, Moderate = Moderate DA, High = High DA)~Overall score, which can range from 0 to 123, a higher score indicates more disease activity"|Day 169|Modified Intent-to-treat (ITT) analysis population: all randomized participants who receive at least one dose of study medication.|||Score on a Scale||95% Confidence Interval|Mean
2546956|NCT02915029|Secondary|8-Item Morisky Score|"Change in Morisky total score on study.The 8-item Morisky scale is a validated scale designed to estimate the risk of medication non-adherence. The Scale of the total score ranges from 0 to 8. We only report a total score. For a reported scale,~Zero reflects worse medication adherence and~8 reflects better medication adherence We didn't combine the subscales to compute a total score, but the total score does reflect the number of individual items that were endorsed."|12 months minus baseline values||||score on a scale||Standard Deviation|Mean
2546957|NCT02915029|Secondary|KDQOL-SF12 Mental Score|Change on study of SF12 mental quality of life scale from the KDQOL-36 Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.|12 months minus baseline values||||score on a scale||Standard Deviation|Mean
2546958|NCT02915029|Secondary|KDQOL-SF12 Physical Score|Changes on study of SF12 physical quality of life scale from the KDQOL-36. Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.|12 months minus baseline values||||score on a scale||Standard Deviation|Mean
2546959|NCT02915029|Secondary|KDQOL-BKD|Change on study of burden of kidney disease score from KDQOL-36. Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.|12 months minus baseline values||||score on a scale||Standard Deviation|Mean
2546960|NCT02915029|Secondary|KDQOL-EKD|Changes in effects of kidney disease score from quality of life (KDQOL). Changes on study of effect of kidney disease from quality of life (KDQOL-36). Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health (SF-12 Physical), mental health (SF-12 Mental), burden of kidney disease (BKD), disease symptoms problem list (SP), and effects of kidney disease (EKD). For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.|12 months minus baseline values||||score on a scale||Standard Deviation|Mean
2546964|NCT02915029|Secondary|Serum Total Protein|Change in total protein on study|12 months minus baseline values||||g/dl||Standard Deviation|Mean
2546965|NCT02915029|Secondary|High Sensitive C-reactive Protein-hsCRP|Changes in the serum c-reactive protein on study|12 months minus baseline values||||mg/L||Inter-Quartile Range|Mean
2546974|NCT02915029|Primary|Patient Activation Measure (PAM) Level Greater Than 2|"Participants in an Activated category. Patient Activation Measure (PAM) questionnaire gives total score of activation as well as levels (stages) of patient activation.~PAM total score can range form 0-100 with higher score reflecting higher level of activation in Patient health care.~PAM levels (Stages) 1 through 4 with 1 being the lowest activation and 4 being the highest activation level. Level 1 labeled as patient being dis-engaged, Level 2 labeled as patient becoming aware of health condition but still struggling, level 3 labeled as patient is taking action and gaining control of their health care and level 4 labeled as maintaining behaviors and pushing forward - for our analysis purposes we classified participants into levels 3 and 4 (activated) and level 1 and 2 as not activated.~We collected data about Changes in PAM score as well as levels (stages) from baseline to 12 months of intervention and compare it to Usual care group."|12 months follow-up||||Participants|||Count of Participants
2546975|NCT02915029|Primary|Patient Activation Measure (PAM) -13 Item Questionnaire|"Patient Activation Measure (PAM) questionnaire gives total score of activation as well as levels (stages) of patient activation.~PAM total score can range form 0-100 with higher score reflecting higher level of activation in Patient health care.~PAM levels (Stages) 1 through 4 with 1 being the lowest activation and 4 being the highest activation level.~We collected data about Changes in PAM score as well as levels (stages) from baseline to 12 months of intervention and compare it to Usual care group."|12 months follow-up minus baseline values||||points||Standard Deviation|Mean
2546976|NCT02914275|Secondary|Geometric Mean Fold Increase (GMFI) of Each Virus Strain|The humoral immune response will be assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate GMFIs, defined as the geometric mean fold titer change (rise) from Day 1 to Study Exit Visit.|Prevaccination (Day 1) and Postvaccination (28 days after last vaccination)|The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.|||Fold Change||95% Confidence Interval|Geometric Mean
2546977|NCT02914275|Secondary|Seroprotection Rates of Each Virus Strain|The humoral immune response will be assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate the percentage of subjects with a titer ≥40 (seroprotection rates) at Day 1 and at Study Exit Visit.|28 days after last vaccination.|The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.|||Percentage of participants||95% Confidence Interval|Number
2546978|NCT02914275|Secondary|Seroconversion Rates (SCRs) of Each Virus Strain|The humoral immune response will be assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate SCRs defined as the % of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination titer.|28 days after last vaccination|The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.|||Percentage of participants||95% Confidence Interval|Number
2546979|NCT02914275|Secondary|Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain|The humoral immune response will be assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate geometric mean of HI titers prevaccination & postvaccination.|28 days after last vaccination.|The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.|||Titers||95% Confidence Interval|Geometric Mean
2546980|NCT02914275|Secondary|Number of Participants With Serious Adverse Events (SAE)|Frequency of SAEs for 180 days after the last vaccination dose. SAE = serious adverse events, AESI = adverse event of special interest|180 days after the last vaccination dose.|The Overall Safety Population was used for the analysis of overall and unsolicited adverse event safety and comprised all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and have provided any evaluable follow-up safety data.|||Participants|||Count of Participants
2546981|NCT02914275|Secondary|Number of Participants With Unsolicited AEs|Frequency and severity of unsolicited AEs for at least 28 days after each vaccination dose|Postvaccination (up to 28 days after vaccination)|The Overall Safety Population was used for the analysis of overall and unsolicited adverse event safety and comprised all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and have provided any evaluable follow-up safety data.|||Participants|||Count of Participants
2546982|NCT02914275|Secondary|Number of Participants With Cellulitis-like Reactions|Frequency of cellulitis-like reactions for at least 28 days after each vaccination dose|Postvaccination (up to 28 days after each vaccination)|The Solicited Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and had provided any evaluable data on solicited events.|||Participants|||Count of Participants
2546983|NCT02914275|Secondary|Number of Participants With Solicited Local Adverse Reactions and Solicited Systemic Adverse Events (AE)|Frequency and severity of solicited local adverse reactions and systemic AEs for 7 days after each vaccination dose|Postvaccination (up to 7 days after vaccination)|The Solicited Safety Population comprises all subjects in the Full Analysis Set (FAS) who received at least one dose or partial dose of Study Vaccine and had provided any evaluable data on solicited events.|||Participants|||Count of Participants
2546984|NCT02914275|Primary|The Difference in Seroconversion Rate (SCR) for Each Virus Strain.|Noninferiority of Seqirus QIV compared to comparator QIV will be assessed by seroconversion rate (SCR) for each viral strain. SCR is defined as the percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI titer. For the SCR comparison, the difference between the SCR for each vaccine (for each strain) will be determined.|Postvaccination (28 days after last vaccination)|The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.|||Percentage of participants||95% Confidence Interval|Number
2547001|NCT02914210|Secondary|10-meter Gait Speed|Gait speed 6 weeks after surgery|6 weeks|Patients randomized and receiving eligible surgery, completing study through 12 weeks, and having gait speed measured.|||minutes||Standard Deviation|Mean
2546985|NCT02914275|Primary|The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.|"Noninferiority of Seqirus QIV compared to comparator QIV was assessed by hemagglutination inhibition (HI) antibody geometric mean titer (GMT) for each viral strain included in the vaccines. The GMT ratio is defined as the geometric mean of the postvaccination HI titer for the US-licensed comparator QIV over the geometric mean of the postvaccination HI titer for Seqirus QIV.~B/VIC = B/Victoria B/YAM = B/Yamagata"|Postvaccination (28 days after last vaccination)|The Per-Protocol Population (PPS) comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.|||Geometric Mean Titer||95% Confidence Interval|Geometric Mean
2546986|NCT02914236|Other Pre-specified|Subject Satisfaction|"Study-specific survey to assess patient satisfaction with the discomfort of the procedure and recovery period, as well as their perceived results. The survey included 5 questions related to tolerability of the procedure, ease of recovery, change in breathing, satisfaction with treatment, and willingness to recommend treatment. Each question was scored on a 10-point scale, with 1 indicating the most negative response to the question (e.g., very bad, much worse, or very dissatisfied) and 10 indicating the most favorable rating (e.g., hardly noticeable, much better, or very satisfied). Each question was individually scored and reported."|26 weeks|Does not include subject lost-to-follow-up prior to 26-week follow-up visit|||units on a scale||Standard Deviation|Mean
2546987|NCT02914236|Other Pre-specified|Subject-reported Pain Related to the Study Procedure, as Reported on 100mm Visual Analog Scale|"Procedure-related pain as reported by the subject using a 100mm Visual Analog Scale (VAS), immediately post-procedure and at the 4-week follow-up visit. Higher scores indicate more severe pain.~The Pain VAS is presented to the subject as a 100mm line anchored on each end by verbal descriptors: 0 = no pain and 100 = worse pain imaginable. The distance between 0 and the vertical mark made by the subject is measured and the result is expressed in millimeters."|Immediately after study procedure, 4-weeks|All treated subjects were asked to rate the pain level in each of their nostrils immediately following the treatment procedure and at the 4-week follow-up visit.|||units on a scale|Nostrils|Standard Deviation|Mean
2546988|NCT02914236|Secondary|Percentage of Participants With Treatment-Related Adverse Events (Safety)|Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure, throughout the follow-up period.|Baseline through 26 weeks|All treated subjects|||percentage of subjects having an event|||Number
2546989|NCT02914236|Secondary|NOSE Responder Rate|Percent subjects who are responders to therapy; responder is defined as a treated subject who experiences at least a 15-point improvement in NOSE score from baseline to 26 weeks post treatment.|Baseline, 26 weeks|Does not include subject lost-to-follow-up prior to 26-week follow-up|||percentage of treated subjects||95% Confidence Interval|Number
2546990|NCT02914236|Primary|Improvement in NOSE Score|"Mean change in Nasal Obstruction Symptom Evaluation (NOSE) score from baseline to 26 weeks post-study procedure. Improvement (baseline score - 26-week score) is signified by a positive value.~The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increased symptoms/symptom severity."|Baseline, 26 weeks|Does not include subject lost-to-follow-up prior to the 26-week follow-up visit|||units on a scale||Standard Deviation|Mean
2546991|NCT02914210|Other Pre-specified|Satisfaction With Tele-rehab Platform|Satisfaction with tele-rehab platform, on scale of 0 to 10, with 10 being highly satisfied.|12 weeks|Patients randomized and receiving eligible surgery, completing study through 12 weeks, using the virtual platform at least once, and providing response to survey question.|||percentage of participants|||Number
2546992|NCT02914210|Other Pre-specified|Satisfaction With Physical Function|Score on Satisfaction with Physical Function questionnaire through 12 weeks after surgery, on a scale of 0 to 6, with 6 being higher satisfaction.|12 weeks|Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.|||score on a scale||Standard Deviation|Mean
2546993|NCT02914210|Other Pre-specified|Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Health (PH) Score|PROMIS physical health score at 12 weeks, on a scale of 0 to 20, with higher scores indicating better physical health.|12 weeks|Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.|||score on a scale||Standard Deviation|Mean
2546994|NCT02914210|Other Pre-specified|Patient-Reported Outcomes Measurement Information System (PROMIS) - Mental Health (MH) Score|PROMIS mental health score at 12 weeks, on a scale of 0 to 20 with higher scores indicating better mental health.|12 weeks|Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.|||score on a scale||Standard Deviation|Mean
2546995|NCT02914210|Other Pre-specified|Return to Work|Return to work (yes, modified schedule, or no) for those who stopped working prior to surgery|6 weeks and 12 weeks|Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.|||Participants|||Count of Participants
2546996|NCT02914210|Other Pre-specified|Physical Activity|Physical activity (duration of moderate exercise in total minutes per week)|6 weeks and 12 weeks|Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.|||minutes per week||Inter-Quartile Range|Median
2546997|NCT02914210|Other Pre-specified|Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores|Scores in KOOS sub-domains of pain, symptoms, activities of daily living (ADL), sports and recreation, and quality of life (QOL). Each sub-domain score can be normalized to values ranging from 0 to 100. Higher scores denote better outcomes.|6 weeks and 12 weeks|Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.|||score on a scale||Standard Deviation|Mean
2546998|NCT02914210|Secondary|Re-hospitalization|Re-hospitalizations since hospital discharge (total count)|12 weeks|Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions.|||number of rehospitalizations per patient||Standard Deviation|Mean
2546999|NCT02914210|Secondary|Report of Falls|Any fall reported between hospital discharge and 12-week follow-up (yes/no)|12 weeks|Patients randomized and receiving eligible surgery, completing study through 12 weeks, and answering survey question regarding falls.|||percentage of patients|||Number
2547002|NCT02914210|Secondary|Range of Motion|Knee range of motion [lower (extension) and upper range of motion (flexion)] at 6 weeks|6 weeks|Patients randomized and receiving eligible surgery, completing study through 12 weeks, and having range of motion measured at specified time point.|||degrees from parallel to floor||Standard Deviation|Mean
2547003|NCT02914210|Secondary|Knee Injury and Osteoarthritis Outcome Score (KOOS)|Survey regarding health [Knee Injury and Osteoarthritis Outcome Score (KOOS)] for pain, symptoms, activities of daily living, function in sports and recreation, and knee-related quality of life (QOL) at 6 weeks and 12 weeks, scored from 0 to 100. Higher score indicates better outcomes.|6 weeks and 12 weeks|Patients randomized and receiving eligible surgery, completing study through 12 weeks, and providing complete responses to survey questions|||score on a scale||Standard Deviation|Mean
2547004|NCT02914210|Primary|Cost Difference in US Dollars|Difference in total health service use costs at 12-weeks postoperative between patients who receive tele-rehab-supported PT versus traditional home and/or clinic-based PT for TKR.|12 weeks|Patients randomized and receiving eligible surgery, and completing the study through 12 weeks post surgery.|||US Dollars||Inter-Quartile Range|Median
2547005|NCT02914184|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity.|During the entire study period (Day 1 to Month 7-8)|Analysis was performed on the Exposed set (ES). The ES included all subjects with at least one study vaccine administration documented. A safety analysis based on the ES included all vaccinated subjects.|||Participants|||Count of Participants
2547006|NCT02914184|Secondary|Number of Subjects With Any Unsolicited AEs.|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined as the occurrence of any unsolicited AE irrespective of its intensity grade and relationship to vaccination.|During the 31 day (Day 1 to Day 31) follow-up period after HRV vaccination across doses|Analysis was performed on the Exposed set (ES). The ES included all subjects with at least one study vaccine administration documented. A safety analysis based on the ES included all vaccinated subjects.|||Participants|||Count of Participants
2547007|NCT02914184|Secondary|Number of Subjects With Any Solicited General Adverse Events (AEs).|Assessed solicited general AEs were cough/runny nose, diarrhea, fever (defined as temperature ≥ 38.0°C), irritability/fussiness, loss of appetite and vomiting. Any solicited general AE is defined as any occurrence of the specified symptom, irrespective of intensity grade and relationship to vaccination.|During the 8 days (Day 1 to Day 8) follow-up period after each dose of HRV vaccine|Analysis was performed on the Exposed Set (ES). The ES included all subjects with at least one study vaccine administration documented. A safety analysis based on the ES included all vaccinated subjects.|||Participants|||Count of Participants
2547008|NCT02914184|Secondary|Percentage of Subjects With Anti-RV IgA Concentrations (Individual HRV Liquid Groups)|Antibody concentrations ≥90 U/mL were determined and expressed as GMCs, assessed for the individual HRV liquid groups and Control Group. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations. The analysis was performed to assess the immunogenicity of the PCV-free liquid HRV vaccine (pooled HRV liquid groups) and the currently licensed lyophilised HRV vaccine, in terms of percentage of subjects with anti-RV IgA antibody concentrations ≥ 90 U/mL 1-2 months after Dose 2.|At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)|The analysis was performed on the PPS for immunogenicity that included all subjects who received both doses of study vaccine and for whom the liquid HRV vaccine or control vaccine was administered according to protocol and for whom immunogenicity data were available at the post-vaccination sampling time point.|||Percentage of subjects||95% Confidence Interval|Number
2547009|NCT02914184|Secondary|Percentage of Subjects With Anti-RV IgA Concentrations (Pooled HRV Liquid Group)|"Antibody concentrations ≥90 U/mL were determined and expressed as GMCs, assessed for the pooled HRV liquid groups and Control Group. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations.~For this outcome measure, the three groups (Liq_A, Liq_B & Liq_C) were pooled into a single group (Liq_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the protocol, the immunogenicity of the Liq_Pool group was compared to the currently licensed lyophilized HRV vaccine (Lyo_Control group) in terms of percentage of subjects with anti-RV IgA antibody concentrations ≥ 90 U/mL, 1-2 months after Dose 2"|At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)|The analysis was performed on the PPS for immunogenicity that included all subjects who received both doses of study vaccine and for whom the liquid HRV vaccine or control vaccine was administered according to protocol and for whom immunogenicity data were available at the post-vaccination sampling time point.|||Percentage of subjects||95% Confidence Interval|Number
2547010|NCT02914184|Primary|Anti-RV IgA Antibody Concentrations in the PCV-free Liquid HRV Vaccine (Individual HRV Liquid Groups) and Lyophilised Control Group|Antibody concentrations against RV were determined as GMCs and expressed as U/mL. The analysis was assessed to demonstrate the immunogenicity of the PCV-free liquid HRV vaccine (individual HRV liquid groups) to that of the currently licensed lyophilised HRV vaccine in terms of serum anti-RV IgA antibody concentrations 1-2 months after Dose 2.|At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)|The analysis was performed on the PPS for immunogenicity that included all subjects who received both doses of study vaccine and for whom the liquid HRV vaccine or control vaccine was administered according to protocol and for whom immunogenicity data were available at the post-vaccination sampling time point.|||U/mL||95% Confidence Interval|Geometric Mean
2547021|NCT02914119|Secondary|Number of Participants With and Without Administration of Sugammadex in Cases Receiving a Non-depolarizing NMBA (Yes/no)||in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours|Only participants with data on the outcome was analyzed, as per protocol.|||Participants|||Count of Participants
2548999|NCT02862730|Secondary|Number of Carbohydrate Treatments|Assess the number of rescue carbohydrate treatments per day across all four arms.|entire 84 hour study|All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.|||number of carbohydrate treatments/day||Standard Deviation|Mean
2547011|NCT02914184|Primary|Anti-RV IgA Antibody Concentrations in the PCV-free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Lyophilised Control Group|"Antibody concentrations against RV were determined as GMCs and expressed as U/mL.~For this outcome measure, the three groups (Liq_A, Liq_B & Liq_C) were pooled into a single group (Liq_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the protocol, the immunological non-inferiority of the Liq_Pool group was compared to the currently licensed lyophilized HRV vaccine (Lyo_Control group) in terms of antibody concentrations at 1-2 months after Dose 2."|At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)|The analysis was performed on the PPS for immunogenicity that included all subjects who received both doses of study vaccine and for whom the liquid HRV vaccine or control vaccine was administered according to protocol and for whom immunogenicity data were available at the post-vaccination sampling time point.|||U/mL||95% Confidence Interval|Geometric Mean
2547012|NCT02914184|Primary|Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to 20 U/mL in Porcine Circovirus (PCV)-Free Liquid HRV Vaccine (Individual HRV Liquid Groups) and Lyophilised Control Group|"Seroconversion rate (SCR) was defined as the percentage of subjects who were initially seronegative (i.e., with anti-RV IgA antibody concentration less than (<) 20 U/mL before the first dose of HRV vaccine) and developed anti-RV IgA antibody concentration greater than or equal to (≥) 20 U/mL at Month 2-4 (1-2 months after dose 2). SCR was analysed using Enzyme Linked Immunosorbent Assay (ELISA).~The analysis was assessed to demonstrate the immunogenicity of PCV-free liquid HRV vaccine as compared to the currently licensed lyophilised HRV vaccine (individual HRV liquid groups) in terms of seroconversion rates 1-2 months after Dose 2."|At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)|The analysis was performed on the PPS for immunogenicity that included all subjects who received both doses of study vaccine and for whom the liquid HRV vaccine or control vaccine was administered according to protocol and for whom immunogenicity data were available at the post-vaccination sampling time point.|||Percentage of subjects||95% Confidence Interval|Number
2547013|NCT02914184|Primary|Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to Cut-off Value in Porcine Circovirus (PCV) -Free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Control Group|"Seroconversion rate (SCR) was defined as the percentage of subjects who were initially seronegative (i.e., with anti-RV IgA antibody concentration less than (<) 20 U/mL before the first dose of HRV vaccine) and developed anti-RV IgA antibody concentration greater than or equal to (≥) 20 U/mL at Month 2-4 (1-2 months after dose 2). SCR was analysed using Enzyme Linked Immunosorbent Assay (ELISA).~For this outcome measure, the three groups (Liq_A, Liq_B & Liq_C) were pooled into a single group (Liq_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the protocol, the immunological non-inferiority of the Liq_Pool group was compared to the currently licensed lyophilized HRV vaccine (Lyo_Control group) in terms of seroconversion rates of 1-2 months after Dose 2."|At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)|The analysis was performed on the PPS for immunogenicity that included all subjects who received both doses of study vaccine and for whom the liquid HRV vaccine or control vaccine was administered according to protocol and for whom immunogenicity data were available at the post-vaccination sampling time point.|||Percentage of subjects||95% Confidence Interval|Number
2547014|NCT02914184|Primary|Anti-Rota Virus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations in the Human Rotavirus (HRV) Liquid Formulation Groups (Liq_A, Liq_B and Liq_C)|Antibody concentrations against Rota Virus (RV) were determined as Geometric Mean Antibody Concentration (GMC) and expressed as Units per milliliter (U/mL).|At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)|The analysis was performed on the Per-protocol analysis set (PPS) for immunogenicity that included all subjects who received both doses of study vaccine and for whom the liquid HRV vaccine or control vaccine was administered according to protocol and for whom immunogenicity data were available at the post-vaccination sampling time point.|||U/mL||95% Confidence Interval|Geometric Mean
2547015|NCT02914132|Secondary|Reduction of Bacteria in Blood Passed Through the Seraph 100 Filter.|Pathogen reduction of > 40 % as CFU/mL or an increase in time to positivity (TTP) of > 22 minutes in blood passed through the Seraph 100 Filter|4 hours||||Participants|||Count of Participants
2547016|NCT02914132|Primary|Demonstrate Safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a Hemodialysis Circuit Assessed by Rate of Adverse Events.|Demonstrate safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a hemodialysis circuit assessed by rate of adverse events. No adverse events occured|14 days||||Percent participants w adverse event|||Number
2547017|NCT02914119|Secondary|Number of Participants With and Without Severe Oxygen Desaturation (<80%) in Cases Receiving a Non-depolarizing NMBA||in the period between tracheal extubation or removal of supraglottic airway device and discharge from post-anaesthesia care unit, assessed up to 24 hours|Only participants with data on the outcome was analyzed, as per protocol.|||Participants|||Count of Participants
2547018|NCT02914119|Secondary|Number of Participants With and Without Mild Oxygen Desaturation (<90%, But >80%) in Cases Receiving a Non-depolarizing NMBA||in the period between tracheal extubation or removal of supraglottic airway device and discharge from post-anaesthesia care unit, assessed up to 24 hours|Only participants with data on the outcome was analyzed, as per protocol.|||Participants|||Count of Participants
2547019|NCT02914119|Secondary|Time in Minutes From Tracheal Extubation or Removal of Supraglottic Airway Device to Discharge From Post-anaesthesia Care Unit in Cases Involving a Non-depolarizing NMBA With and Without Neuromuscular Monitoring, Respectively||in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes|Only participants with data on the outcome was analyzed, as per protocol.|||Minutes||Inter-Quartile Range|Median
2547020|NCT02914119|Secondary|Number of Participants With and Without Administration of Neostigmine in Cases Receiving a Non-depolarizing NMBA (Yes/no)||in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours|Only participants with data on the outcome was analyzed, as per protocol.|||Participants|||Count of Participants
2547022|NCT02914119|Secondary|Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA|The train-of-four (TOF) ratio is the ratio between the last and first measurements after four stimuli of the ulnar nerve at 2 Hz. The ratio should be at least 0.9 before tracheal extubation.|in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours|Only participants with data on the outcome was analyzed, as per protocol.|||Train-of-four ratio||Inter-Quartile Range|Median
2547023|NCT02914119|Primary|Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing NMBA (Succinylcholine) (Yes/no)||in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours|Patients receiving succinylcholine only|||Participants|||Count of Participants
2547024|NCT02914119|Primary|Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing Neuromuscular Blocking Agent (NMBA) (Yes/no)||in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours|Patients receiving non-depolarizing neuromuscular blocking agent|||Participants|||Count of Participants
2547025|NCT02913326|Secondary|Percentage of Participants With Any Bleeding Event After up to 24 Weeks|Percentage of participants with any bleeding event after up to 24 weeks where any bleeding event is the sum of all major and non-major bleeding events.|From first administration of trial medication until end of treatment visit, up to 24 weeks.|TS|||Percentage of participants||95% Confidence Interval|Number
2547026|NCT02913326|Secondary|Percentage of Participants With Major Bleeding According to ISTH Criteria or CRNMBEs After up to 24 Weeks|Percentage of participants with major bleeding according to ISTH criteria or CRNMBEs after up to 24 weeks.|From first administration of trial medication until end of treatment visit, up to 24 weeks.|TS|||Percentage of participants||95% Confidence Interval|Number
2547027|NCT02913326|Secondary|Percentage of Participants With Clinically Relevant Non-major Bleeding Events in Full Observation Period.|A clinically relevant non-major bleeding event (CRNMBE) was a clinically overt bleed that did not meet the criteria for a major bleed but prompted a clinical response, in that it led to at least 1 of the following: A hospital admission (i.e. overnight stay in the hospital) for bleeding / A physician guided medical or surgical treatment for bleeding / A physician guided change, interruption or discontinuation of trial medication.|From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.|TS|||Percentage of participants||95% Confidence Interval|Number
2547028|NCT02913326|Secondary|Composite Endpoint of Percentage of Participants With New Intracranial Haemorrhage or Worsening of the Haemorrhagic Component of a Previous Lesion After up to 24 Weeks|Intracranial haemorrhage (ICH) comprised the subtypes of intracerebral bleeds, subdural bleeds, epidural bleeds and subarachnoid bleeds that were recorded.|From first administration of trial medication until end of treatment visit, up to 24 weeks.|TS - Patients with missing/not analysable MRI scan at baseline or EOT are excluded from the analysis|||Percentage of participants||95% Confidence Interval|Number
2547029|NCT02913326|Secondary|Percentage of Participants With Major Bleeding According to ISTH Criteria in Full Observation Period|"Major bleeds were defined according to the ISTH definition of a major bleed, as follows:~Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or~Bleeding associated with a reduction in haemoglobin of at least 2 grams/deciLitre (1.24 millimole/Litre) within 24 h, or leading to transfusion of 2 or more units of blood or packed cells and/or~Fatal bleed"|From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.|TS|||Percentage of participants||95% Confidence Interval|Number
2547030|NCT02913326|Secondary|Cerebral Venous Recanalisation as Measured by the Change in Number of Occluded Cerebral Veins and Sinuses at Week 24|"Cerebral venous recanalisation was assessed by imaging and was adjudicated. Occlusion of cerebral veins and sinuses was scored as: 1 = full occlusion; 0 = no occlusion/partial occlusion. This score was applied using the below conventions: Superior sagittal, straight, cavernous sinuses, left and right jugular veins each scored individually as either 0 or 1; Right lateral transverse and sigmoid sinus were scored together, Left lateral transverse and sigmoid sinus were scored together, Superior petrous sinus and inferior petrous sinus were scored together; Deep venous system, Superficial cortical veins, Cerebellar veins were scored as systems.~For each patient a total score was calculated at baseline and at EOT and the recanalisation score was calculated as EOT - baseline total scores with conventions as 0 = no cerebral veins or sinuses fully occluded and 11 = all cerebral veins and sinuses fully occluded; the lower the score, the better."|Baseline and week 24|FAS - Patients with missing/not analysable MRI scan at baseline or end of treatment (EOT) are excluded from the analysis|||Units on scale||Standard Deviation|Mean
2547031|NCT02913326|Secondary|Percentage of Participants With Recurring Cerebral Venous and Dural Sinus Thrombosis; DVT of Any Limb, PE or Splanchnic Vein Thrombosis in Full Observation Period|"VTE criterions:~New neurological signs/symptoms or worsening of previous signs/symptoms with new CVT on neuroimaging.~DVT of any limb was documented by: Abnormal compression ultrasonography; An intraluminal filling defect on venography; At autopsy~Splanchnic vein thrombosis: The presence of endoluminal material/absence of flow in the extrahepatic portal veins/mesenteric veins as shown by duplex-Doppler ultrasound/contrast-enhanced CT scan/MRI.~PE was documented by: An intraluminal filling defect in segmental/more proximal branches on spiral CT scan; An intraluminal filling defect/an extension of an existing defect/a sudden cut-off of vessels>2.5 mm in diameter on the pulmonary angiogram; Perfusion defect of at least 75% of a segment with a local normal ventilation result on ventilation/perfusion lung scan; Inconclusive spiral CT, pulmonary angiography/lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasonography/venography; At autopsy."|From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.|"FAS,~Magnetic resonance imaging (MRI), Computed tomography (CT)"|||Percentage of participants||95% Confidence Interval|Number
2547041|NCT02913105|Secondary|Change From Baseline in Weight|Baseline was defined as the last available measurement prior to the first dose.|Baseline to Days 28, 42, 56, 84 and 112 (EOS)|PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Number analyzed included participants with a value at both Baseline and that time point.|||kilogram (kg)||Standard Deviation|Mean
2547032|NCT02913326|Primary|Percentage of Participants With Composite of Venous Thrombotic Event (VTE) or Major Bleeding Event (MBE) According to International Society on Thrombosis and Haemostasis (ISTH) Criteria in Full Observation Period.|"Composite of the percentage of participants with MBE according to ISTH criteria and VTE (recurring cerebral venous thrombosis (CVT); deep venous thrombosis (DVT) of any limb, pulmonary embolism (PE), splanchnic vein thrombosis) in full observation period. All components were adjudicated in a blinded manner.~Major bleeds were defined according to the ISTH definition of a major bleed, as follows:~Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or~Bleeding associated with a reduction in haemoglobin of at least 2 grams/deciLitre (1.24 millimole/Litre) within 24 h, or leading to transfusion of 2 or more units of blood or packed cells and/or~Fatal bleed"|From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.|Full analysis set (FAS): All patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took study medication. This followed the intent-to-treat principle.|||Percentage of participants||95% Confidence Interval|Number
2547033|NCT02913105|Secondary|Change From Baseline in Visual Analog Scale (VAS) for Itching of Skin|A 10 cm VAS was used to assess the severity of participants itch (ranging from 0 = no itch at all to 10 = the worst imaginable itch). The score (distance from left) on the VAS was recorded by the participant marking with a line and used to test for an effect of LMB763 over placebo. Baseline was defined as the last available measurement prior to the first dose. A positive change from Baseline indicates improvement.|Baseline to Day 84 (Week 12)|PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Number analyzed included participants with a value at both Baseline and that time point.|||score on a scale||Standard Deviation|Mean
2547034|NCT02913105|Secondary|Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) and Low-density Lipoprotein (LDL) Cholesterol|Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain).|Baseline to Days 7, 14, 28, 42, 56, 84 and 112 (EOS)|PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Number analyzed included participants with a value at both Baseline and that time point.|||millimole per liter (mmol/L)||Geometric Coefficient of Variation|Geometric Mean
2547035|NCT02913105|Secondary|Change From Baseline in Fasting Lipid Profile: Cholesterol (Chol) and Triglycerides (TG)|Lipid measurements were collected under fasted conditions. Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain).|Baseline to Days 7, 14, 28, 42, 56, 84 and 112 (EOS)|PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Number analyzed included participants with a value at both Baseline and that time point.|||milligrams per deciliter (mg/dL)||Geometric Coefficient of Variation|Geometric Mean
2547036|NCT02913105|Secondary|Change From Baseline in Fibrosis Biomarker Test|Fibrosis Biomarker test included hyaluronic acid (HA), amino-terminal pro-peptide of procollagen type III (PIIINP), and tissue inhibitor of metalloproteinases (TIMP-1) as markers of liver fibrosis. Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain).|Baseline to Days 42 and 84|PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Number analyzed in the number of participants with all observations non-missing, including censored data.|||micrograms per liter (ug/L)||Geometric Coefficient of Variation|Geometric Mean
2547037|NCT02913105|Secondary|Change From Baseline in Enhanced Liver Fibrosis (ELF) Test Panel|"The ADVIA CentaurR systems' ELF™ test is an in vitro diagnostic multivariate index assay that provides a single score by combining quantitative measurements of hyaluronic acid (HA), amino-terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloproteinase 1 (TIMP-1) in human serum using the ADVIA Centaur XP, ADVIA Centaur XPT, and ADVIA Centaur CP systems in an algorithm. ELF score for the ADVIA Centaur systems is calculated by, first obtaining results for the ADVIA Centaur HA, PIIINP, and TIMP-1 assays and then using the following equation/algorithm:~ADVIA Centaur XP/XPT:~ELF score = 2.278 + 0.851 ln(CHA) + 0.751 ln(CP3NP) + 0.394 ln(CTIMP1)~ADVIA Centaur CP:~ELF score = 2.494 + 0.846 ln(CHA) + 0.735 ln(CP3NP) + 0.391 ln(CTIMP1) Concentrations (C) of each assay are in ng/mL~Interpretation of ELF score is as follows:~< 7.7 None to mild~7.7 to < 9.8 Moderate~9.8 Severe"|Baseline to Days 42 and 84|PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Number analyzed included participants with a value at both Baseline and that time point.|||ELF score||Geometric Coefficient of Variation|Geometric Mean
2547038|NCT02913105|Secondary|Change From to Baseline in Liver Stiffness|Fibroscan® was performed where available to assess liver stiffness. Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain).|Baseline to Day 84 (Week 12)|PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Number analyzed included participants with a value at both Baseline and that time point.|||kilopascal (kPa)||Geometric Coefficient of Variation|Geometric Mean
2547039|NCT02913105|Secondary|Change From Baseline in Waist to Hip Ratio|Baseline was defined as the last available measurement prior to the first dose.|Baseline to Days 28, 42, 56, 84 and 112 (EOS)|PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Number analyzed included participants with a value at both Baseline and that time point.|||ratio||Standard Deviation|Mean
2547040|NCT02913105|Secondary|Change From Baseline in Body Mass Index (BMI)|Baseline was defined as the last available measurement prior to the first dose at specified visit (day).|Baseline to Days 28, 42, 56, 84 and 112 (EOS)|PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Number analyzed included participants with a value at both Baseline and that time point.|||kilograms per meter square (kg/m^2)||Standard Deviation|Mean
2547042|NCT02913105|Secondary|Change From Baseline in Percentage of Liver Fat as Measured by Magnetic Resonance Imaging (MRI)|Participants were to undergo MRI twice (Baseline and End of Treatment) during the course of the study to quantitate liver fat. Baseline was defined as the last available measurement prior to the first dose. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain).|Baseline to Day 84 (Week 12)|PD analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Number analyzed included participants with a value at both Baseline and that time point.|||percentage of liver fat||Geometric Coefficient of Variation|Geometric Mean
2547043|NCT02913105|Secondary|Accumulation Ratio (Racc) of LMB763|"The drug accumulation ratio (Racc) is the ratio of accumulation of drug going from a single dose to steady state with repeated administration.~No statistical analysis was planned for this outcome measure."|Day 42|PK analysis set included all participants with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and with no protocol deviations that impact on PK data.|||ratio||Standard Deviation|Mean
2547044|NCT02913105|Secondary|Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of LMB763|No statistical analysis was planned for this outcome measure.|0 to 96 hours post-dose on Days 1 and 42|PK analysis set included all participants with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and with no protocol deviations that impact on PK data. Number analyzed is the number of participants with data available for analysis at specified time-point.|||h*ng/mL||Standard Deviation|Mean
2547045|NCT02913105|Secondary|Time to Reach Maximum Concentration (Tmax) of LMB763|No statistical analysis was planned for this outcome measure.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 42|PK analysis set included all participants with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and with no protocol deviations that impact on PK data. Number analyzed is the number of participants with data available for analysis at specified time-point.|||hour (h)||Full Range|Median
2547046|NCT02913105|Secondary|Observed Maximum Plasma Concentration (Cmax) of LMB763|No statistical analysis was planned for this outcome measure.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Days 1 and 42|Pharmacokinetic (PK) analysis set included all participants with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and with no protocol deviations that impact on PK data. Number analyzed is the number of participants with data available for analysis at specified time-point.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2547047|NCT02913105|Primary|Change From Baseline in Alanine Aminotransferase (ALT) Levels|ALT level assessment is one of the diagnostic parameters in Liver function test (LFT). Baseline was defined as the mean of ALT levels at baseline and pre-dose visits. Geometric Mean and Geometric Coefficient of Variation for change are based on log-transformed ratio to baseline (i.e., change from baseline in the log domain).|Baseline to Day 84 (Week 12)|Pharmacodynamic (PD) analysis set included all participants with available PD data and no protocol deviations with relevant impact on PD data. Number analyzed included participants with a value at both Baseline and that time point.|||units per liter (U/L)||Geometric Coefficient of Variation|Geometric Mean
2547048|NCT02913105|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation as per Medical or scientific judgment. No statistical analysis was planned for this primary outcome measure.|From date of First Participant First Treatment until Last Patient Last Visit (up to Day 112 (End of Study (EOS))|Safety analysis set included all participants that received at least one dose of study drug.|||Participants|||Count of Participants
2547049|NCT02912650|Other Pre-specified|Participant's Global Evaluation of Study Medication|Participant global evaluation of study medication was performed at the 12-hour time point or immediately before taking the rescue medication. It was scored on a 6-point categorical scale where 0= Very poor, 1= Poor, 2= Fair, 3= Good, 4= Very Good and 5= Excellent.|0 to 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2547050|NCT02912650|Other Pre-specified|Cumulative Percentage of Participants With Meaningful Relief|"Percentage of participants with meaningful relief was reported. Participants evaluated time to meaningful relief by stopping a second stopwatch labeled meaningful relief at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy."|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||percentage of participants|||Number
2547051|NCT02912650|Other Pre-specified|Cumulative Percentage of Participants With Confirmed First Perceptible Relief|Percentage of participants with confirmed first perceptible relief was reported. Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labelled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||percentage of participants|||Number
2547287|NCT02909140|Secondary|Cumulative Energy Dispersed for Each Arm|The amount of energy needed to break up the cataractous lens|During cataract surgery|"Data was only collected for the Intracameral Mydriasis' arm. We analyzed data for 1 participant only because of lack of data for the other participant."|||Percent-seconds|||Number
2547052|NCT02912650|Other Pre-specified|Cumulative Percentage of Participants With Treatment Failure|Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. Percentage of participants who had treatment failure were reported.|1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||percentage of participants|||Number
2547053|NCT02912650|Other Pre-specified|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores on 4-Point Categorical Scale (SPRID4) Over 2, 6, 8, 12 and 6 to 8 Hours Post-dose|SPRID4: Time-weighted sum of PRR and PID based on 4 point categorical pain severity rating scale (PRID) with score range: -2(worst score) to 14 (best score) for SPRID 0-2, -6 (worst score) to 42 (best score) for SPRID 0-6, -8 (worst score) to 56 (best score) for SPRID 0-8, -12 (worst score) to 84 (best score) for SPRID 0-12 and -3 (worst score) to 21 (best score) for SPRID 6-8 hours. PRID: sum of PID and PRR at post-dose time point with score range: -1 (worst score) to 7 (best score). PID calculated by subtracting pain intensity score at post-dose time points (score range: 0 [none] to 3 [severe]) from baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline score of at least moderate were included). PID total possible score range: -1 (worst score) to 3(best score). PRR assessed on 5-point categorical scale with range: 0 =no relief to 4 =complete relief.|0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12, 6 to 8 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2547054|NCT02912650|Other Pre-specified|Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post Dose|TOTPAR: Time-weighted sum of PRR scores over 2, 6 and 12 hours. TOTPAR total score range: 0 (worst score) to 8 (best score) for TOTPAR 0-2, 0 (worst score) to 24 (best score) for TOTPAR 0-6, 0 (worst score) to 32 (best score) for TOTPAR 0-8, 0 (worst score) to 48 (best score) for TOTPAR 0-12. PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.|0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2547055|NCT02912650|Other Pre-specified|Time-weighted Sum of Pain Intensity Difference Scores on 4-Point Categorical Scale (SPID4) From 0 to 2 Hours, 0 to 6 Hours, 0 to 8 Hours, 0 to 12 Hours and 6 to 8 Hours Post-dose|Pain intensity was assessed on a 4-point categorical pain severity rating scale. SPID4: Time-weighted sum of PID over post-dose time points. SPID4 score range was -2 (worst score) to 6 (best score) for SPID 0-2, -6 (worst score) to 18 (best score) for SPID 0-6, -8 (worst score) to 24 (best score) for SPID 0-8, -12 (worst score) to 36 (best score) for SPID 0-12 and -3 (worst score) to 9 (best score) for SPID 6-8. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [none] to 3 [severe]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 = severe pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -1 (worst score) to 3 (best score).|0 to 2 hours, 0 to 6 hours, 0 to 8 hours, 0 to 12, 6 to 8 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2547056|NCT02912650|Other Pre-specified|Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale (SPID11) From 0 to 2 Hours, 0 to 6 Hours and 0 to 12 Hours Post-dose|Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11: Time-weighted sum of PID scores over 12 hours. SPID11 score range was -10 (worst score) to 20 (best score) for SPID 0-2, -30 (worst score) to 60 (best score) for SPID 0-6, -60 (worst score) to 120 (best score) for SPID 0-12. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst) to 10 (best).|0 to 2 hours, 0 to 6 hours, 0 to 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2547057|NCT02912650|Other Pre-specified|Sum of Pain Relief Rating and Pain Intensity Difference on 4-Point Categorical Scale (PRID4)|PRID4: sum of PID and PRR at each post-dose time points up to 12 hours. Score range for PRID: -1(worst score) to 7(best score). PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [no pain] to 3 [worst possible pain]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score). PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2547058|NCT02912650|Other Pre-specified|Pain Intensity Difference on 4-Point Categorical Scale (PID4)|PID4: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on a 4-point categorical pain severity rating scale. PID4 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 [no pain] to 3 [worst possible pain]) from the baseline pain intensity scores (score range: 2 =moderate pain to 3 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID4: -1 (worst score) to 3 (best score).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2547100|NCT02912468|Secondary|Change From Baseline at Week 24 in the University of Pennsylvania Smell Identification Test (UPSIT) Score|The UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia) to 40 (normal sense of smell), lower score indicated severe smell loss. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview.|Baseline, Week 24|The analysis was performed on ITT. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547059|NCT02912650|Other Pre-specified|Pain Intensity Difference on 11-Point Numerical Scale (PID11)|PID11: baseline pain severity score minus pain severity score at a given time point. Pain intensity was assessed on an 11-point numerical pain severity rating scale. PID11 was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID11: -5 (worst score) to 10 (best score).|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2547060|NCT02912650|Other Pre-specified|Pain Relief Rating (PRR) Score|"Participants answered a question: how much relief do you have from your starting pain? on a 5-point categorical pain relief rating scale. Scale ranges from 0= no relief to 4= complete relief."|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2547061|NCT02912650|Other Pre-specified|Time to Confirmed Onset of First Perceptible Relief|Participants evaluated the time to first perceptible relief (confirmed by meaningful relief) by stopping the first stopwatch labeled 'first perceptible relief' at the moment they first began to experience any pain relief, if the participant also achieved meaningful relief by the end of the study. Stopwatch was active up to 12 hours after dosing or until stopped by the participant, or until the participant dropped out due to treatment failure prior to depressing the first stopwatch or until the time of withdrawal (discontinuation). Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy.|0 to 12 hours post-dose|"FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment. Here, number of participants analyzed signifies those participants who had the event (first perceptiblre relief)."|||minutes||95% Confidence Interval|Median
2547062|NCT02912650|Secondary|Time to Onset of Meaningful Pain Relief|"Participants evaluated time to meaningful relief by stopping a second stopwatch labelled as meaningful relief at the moment they first began to experience meaningful relief. Stopwatch was active up to 12 hours after dosing or until stopped by participant, or participant became treatment failure prior to depressing the second stopwatch. Treatment failure was defined as participant taking rescue medication, or discontinuing due to lack of efficacy."|0 to 12 hours post-dose|"FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment. Here, number of participants analyzed signifies those participants who had the event (meaningful pain relief)."|||minutes||95% Confidence Interval|Median
2547063|NCT02912650|Secondary|Cumulative Percentage of Participants With Treatment Failure at 6 and 8 Hours|Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first. Percentage of participants who had treatment failure were reported.|6 hours, 8 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||percentage of participants|||Number
2547064|NCT02912650|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time interval from the study drug administration up to the first documentation of treatment failure. Treatment failure was defined as taking the rescue medication or discontinuation of the participants from the study due to lack of efficacy, whichever came first. Participants were censored at 12 hours or at their final assessment time, whichever came first.|0 to 12 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||minutes||95% Confidence Interval|Median
2547065|NCT02912650|Secondary|Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 8 Hours and 6 to 8 Hours Post-dose|TOTPAR: Time-weighted sum of Pain Relief Rating (PRR) scores over 0 to 8 and 6 to 8 hours. TOTPAR total score range: 0 (worst score) to 32 (best score) for TOTPAR 0-8 and 0 (worst score) to 12 (best score) for TOTPAR 6-8 hours. PRR was assessed on a 5-point categorical pain relief rating scale which ranges from 0 =no relief to 4 =complete relief.|0 to 8 hours, 6 to 8 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2547066|NCT02912650|Secondary|Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 6 to 8 Hours Post-dose (SPID11 [6-8])|Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 (6-8): Time-weighted sum of PID scores over 6 to 8 hours. SPID11 score range was -15 (worst score) to 30 (best score) for SPID 6-8. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).|6 to 8 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2547067|NCT02912650|Primary|Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 8 Hours Post-dose (SPID11 [0-8])|Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 (0-8): Time-weighted sum of pain intensity difference (PID) scores over 8 hours. SPID11 score range was -40 (worst score) to 80 (best score) for SPID 0-8. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).|0 to 8 hours post-dose|FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Deviation|Mean
2547111|NCT02912195|Secondary|Patient Satisfaction|"The proportion of patients saying, Yes to Would you have this pain medication again for similar pain?"|60 minutes|1 patient in the intravenous lidocaine arm did not answer the question.|||Participants|||Count of Participants
2547112|NCT02912195|Secondary|Number of Participants Requiring Rescue Medications|The percentage of patients requiring rescue IV morphine at 20 and 40 minutes|At 20 and 40 minutes||||Participants|||Count of Participants
2547068|NCT02912468|Secondary|Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Prior Nasal Polyp Surgery|The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, and regions as covariates.|Baseline, Week 24|Analysis was performed on a subset of participants, which included all randomized participants with prior NP surgery history and had available data for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547069|NCT02912468|Secondary|Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Asthma|The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates.|Baseline, Week 24|Analysis was performed on a subset of participants, which included all randomized participants with asthma and had available data for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547070|NCT02912468|Secondary|Change From Baseline at Week 24 in Nasal Polyp Score: Subgroup of Participants With Prior Nasal Polyp Surgery|NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model.|Baseline, Week 24|Analysis was performed on a subset of participants, which included all randomized participants with prior NP surgery history and had available data for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547071|NCT02912468|Secondary|Change From Baseline at Week 24 in Nasal Polyp Score: Subgroup of Participants With Asthma|NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model.|Baseline, Week 24|Analysis was performed on a subset of participants, which included all randomized participants with asthma and had available data for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547072|NCT02912468|Secondary|Change From Baseline at Week 24 in Nasal Congestion Symptom Severity Score: Subgroup of Participants With Prior Nasal Polyp Surgery|NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, and regions as covariates.|Baseline, Week 24|Analysis was performed on a subset of participants, which included all randomized participants with prior NP surgery history.|||score on a scale||Standard Error|Least Squares Mean
2547073|NCT02912468|Secondary|Change From Baseline at Week 24 in Nasal Congestion Symptom Severity Score: Subgroup of Participants With Asthma|NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates.|Baseline, Week 24|Analysis was performed on a subset of participants, which included all randomized participants with asthma.|||score on a scale||Standard Error|Least Squares Mean
2547074|NCT02912468|Secondary|Change From Baseline at Week 24 in European Quality of Life 5 Dimension (EQ-5D) Visual Analog Scale Score|The EQ-5D was a standardized HRQoL questionnaire consisting of EQ-5D descriptive system and EQ VAS. EQ-5D descriptive system comprised of 5 dimensions: mobility, selfcare, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. EQ-VAS recorded the participant's self-rated health on a vertical VAS that allowed them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable).|Baseline, Week 24|The analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547075|NCT02912468|Secondary|Total Systemic Corticosteroids Rescue Intake Duration: Average Duration Per Participant|Rescue treatment was defined as usage of SCS or NP surgery (actual or planned) during the treatment period. SCS rescue intake duration was defined as the duration (in days) from start of SCS rescue medication till the end of SCS rescue treatment.|Baseline to Week 24|The analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||days||Standard Deviation|Mean
2547113|NCT02912195|Secondary|Pain Relief at 60 Minutes Compared to Baseline.|Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 60 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.|At 60 minutes||||units on a scale||95% Confidence Interval|Mean
2547288|NCT02909140|Secondary|Percentage of Patients in Each Arm That Required Another Mydriatic Agent||intraoperative|"Data was only collected for the Intracameral Mydriasis' arm"|||percent of participants|||Number
2547076|NCT02912468|Secondary|Mean Total Systemic Corticosteroids Rescue Dose Prescribed During Treatment Period|SCS included: Betamethasone, dexamethasone, dexamethasone sodium phosphate, hydrocortisone sodium succinate, methylprednisolone, prednisolone, prednisolone metasulfobenzoate sodium, prednisone, and triamcinolone. For every participant, total dose was calculated as (prescribed total daily dose*duration of SCS use). Then, mean of the total dose of 25 participants (placebo group) and 9 participants (Dupilumab group) was derived.|Baseline to Week 24|The analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||milligrams||Standard Deviation|Mean
2547077|NCT02912468|Secondary|Number of Participants With Treatment-Emergent And Treatment-Boosted Anti-drug Antibodies (ADA) Response|ADA response were categorized as: treatment emergent and treatment boosted response. 1) Treatment emergent was defined as a positive response in the ADA assay post first dose, when baseline results are negative or missing. 2) Treatment boosted was defined as: An ADA positive response in the assay post first dose that is greater-than or equal to 4-fold over baseline titer levels, when baseline results are positive.|Baseline to End of study (Week 48)|The analysis was performed on ADA population which included participants who received at least 1 dose of IMP with at least one non-missing ADA assay result following the first dose of the study medication.|||Participants|||Count of Participants
2547078|NCT02912468|Secondary|Functional Dupilumab Concentration in Serum||Baseline, Week 4, 8, 16, 24, 36, End of study (Week 48)|Analysis performed on pharmacokinetic population, which included participants who received atleast 1 dose of IMP with atleast 1 evaluable functional IMP concentration. Here, ‘number analyzed’=number of participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for placebo|||nanogram/milliliter||Standard Deviation|Mean
2547079|NCT02912468|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation|An Adverse Event (AE) was defined as any untoward medical occurrence that did not necessarily have to have a causal relationship with the study treatment. TEAEs were defined as AEs that developed or worsened in grade or became serious during TEAE period which was defined as the period from the time of first dose of study drug until 98 days following the last administration of study drug. Serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.|Baseline up to 98 days following the last administration of study drug (up to 36 weeks)|The analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the Investigational Medicinal Product (IMP), analyzed according to the treatment actually received.|||Participants|||Count of Participants
2547080|NCT02912468|Secondary|Change From Baseline at Week 48 in Asthma Control Questionnaire-6 Scores for Participants With Asthma (Assessment Performed 24 Weeks After End of Treatment)|ACQ-6 had 6 questions which assessed the most common asthma symptoms (woken by asthma, symptoms on waking, activity limitation, shortness of breath, wheezing, puffs/inhalations use). Participants were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale ranged from 0 = no impairment to 6 = maximum impairment. The ACQ-6 score was the mean of the scores of all 6 questions and therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), with higher scores indicated lower asthma control. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, prior surgery, and regions as covariates.|Baseline, Week 48 (Post-baseline assessment performed 24 weeks after end of treatment)|Analysis was performed on a subset of participants which included all randomized participants with asthma and had available data for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547081|NCT02912468|Secondary|Change From Baseline at Week 48 in Forced Expiratory Volume in 1 Second for Participants With Asthma (Assessment Performed 24 Weeks After End of Treatment)|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates.|Baseline, Week 48 (Post-baseline assessment performed 24 weeks after end of treatment)|Analysis was performed on a subset of participants which included all randomized participants with asthma.|||liters||Standard Error|Least Squares Mean
2547082|NCT02912468|Secondary|Change From Baseline at Weeks 28, 32, 36, 40, 44 and 48 in Rhinorrhea Daily Symptom Score (Assessments Performed 4-24 Weeks After End of Treatment)|Rhinorrhea was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), where higher scores indicated more severe symptoms. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.|Baseline, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 (Post-baseline assessments performed 4-24 weeks after end of treatment)|The analysis was performed on ITT population.|||score on a scale||Standard Error|Least Squares Mean
2547083|NCT02912468|Secondary|Change From Baseline at Weeks 36 and 48 in Visual Analog Scale for Rhinosinusitis (Assessments Performed 12 and 24 Weeks After End of Treatment)|"The VAS for rhinosinusitis was used to evaluate the total disease severity. The participants were asked to indicate on a 10 cm VAS the answer to the question, How troublesome are your symptoms of your rhinosinusitis? The range of the VAS was from 0 (not troublesome) to 10 (worse thinkable troublesome), where higher score indicated worse thinkable troublesome. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates."|Baseline, Week 36 and Week 48 (Post-baseline assessments performed 12 and 24 weeks after end of treatment)|The analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||centimeters||Standard Error|Least Squares Mean
2547114|NCT02912195|Secondary|Pain Relief at 50 Minutes Compared to Baseline.|Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 50 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.|At 50 minutes||||units on a scale||95% Confidence Interval|Mean
2547084|NCT02912468|Secondary|Rescue Treatment Use: Estimate of Percentage of Participants With >=1 Event by Week 48 Obtained Using Kaplan-Meier Method|"Rescue treatment was defined as usage of SCS or NP surgery (actual or planned) during the study. Rescue treatment included:~SCS: Betamethasone, dexamethasone, dexamethasone sodium phosphate, Hydrocortisone sodium succinate, methylprednisolone, prednisolone, prednisolone metasulfobenzoate sodium, prednisone, and triamcinolone.~Sino-nasal surgery for nasal polyps when there was worsening of signs and/or symptoms during the study.~Estimate of percentage of participants with event by Week 48 was obtained using Kaplan-Meier method."|Baseline up to Week 48|The analysis was performed on ITT population.|||percentage of participants with event||95% Confidence Interval|Number
2547085|NCT02912468|Secondary|Change From Baseline at Weeks 36 and 48 in 22-item Sino-nasal Outcome Test Scores (Assessments Performed 12 and 24 Weeks After End of Treatment)|The SNOT-22 is a validated questionnaire that was used to assess the impact of CRSwNP on HRQoL. It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.|Baseline, Week 36 and Week 48 (Post-baseline assessments performed 12 and 24 weeks after end of treatment)|The analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547086|NCT02912468|Secondary|Change From Baseline at Weeks 28, 32, 36, 40, 44 and 48 in Severity of Decreased/Loss of Smell as Assessed by Participant Daily (Assessments Performed 4-24 Weeks After End of Treatment)|The severity of decreased/loss of sense of smell was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), higher score indicated more severe symptoms. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.|Baseline, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 (Post-baseline assessments performed 4-24 weeks after end of treatment)|The analysis was performed on ITT population.|||score on a scale||Standard Error|Least Squares Mean
2547087|NCT02912468|Secondary|Change From Baseline at Week 48 in University of Pennsylvania Smell Identification Test (Assessment Performed 24 Weeks After End of Treatment)|The UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia) to 40 (normal sense of smell), lower score indicated severe smell loss. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.|Baseline, Week 48 (Post-baseline assessment performed 24 weeks after end of treatment)|The analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547088|NCT02912468|Secondary|Change From Baseline at Weeks 28, 32, 36, 40, 44 and 48 in Total Symptom Score (Assessments Performed 4-24 Weeks After End of Treatment)|The TSS was the sum of participant-assessed nasal symptom scores for NC/obstruction, decreased/loss of sense of smell, and rhinorrhea (anterior/posterior nasal discharge), each accessed on 0-3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms). Total score ranged from 0 (no symptoms) to 9 (severe symptoms). Higher score indicated more severe symptoms. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.|Baseline, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 (Post-baseline assessments performed 4-24 weeks after end of treatment)|The analysis was performed on ITT population.|||score on a scale||Standard Error|Least Squares Mean
2547089|NCT02912468|Secondary|Change From Baseline at Week 48 in Opacification of Sinuses Measured by Lund-Mackay Score (Assessment Performed 24 Weeks After End of Treatment)|The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.|Baseline, Week 48 (Post-baseline assessment performed 24 weeks after end of treatment)|The analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547090|NCT02912468|Secondary|Change From Baseline at Weeks 36 and 48 in Nasal Polyp Score (Assessments Performed 12 and 24 Weeks After End of Treatment)|NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded based on polyp size from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model.|Baseline, Week 36, Week 48 (post-baseline assessments performed 12 and 24 weeks after end of treatment)|The analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547115|NCT02912195|Secondary|Pain Relief at 40 Minutes Compared to Baseline.|Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 40 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.|At 40 minutes||||units on a scale||95% Confidence Interval|Mean
2547116|NCT02912195|Secondary|Pain Relief at 30 Minutes Compared to Baseline.|Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 30 minutes NRS is a scale ranging from 0, no pain, to 10 worst pain.|at 30 minutes||||units on a scale||95% Confidence Interval|Mean
2547091|NCT02912468|Secondary|Change From Baseline at Weeks 28, 32, 36, 40, 44 and 48 in Nasal Congestion Symptom Severity Score (Assessments Performed 4-24 Weeks After End of Treatment)|NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.|Baseline, Week 28, Week 32, Week 36, Week 40, Week 44 and Week 48 (Post-baseline assessments performed 4-24 weeks after end of treatment)|The analysis was performed on ITT population.|||score on a scale||Standard Error|Least Squares Mean
2547092|NCT02912468|Secondary|Change From Baseline at Week 24 in Asthma Control Questionnaire-6 (ACQ-6) Scores for Participants With Asthma|ACQ-6 had 6 questions which assessed the most common asthma symptoms (woken by asthma, symptoms on waking, activity limitation, shortness of breath, wheezing, puffs/inhalations use). Participants were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale ranged from 0 = no impairment to 6 = maximum impairment. The ACQ-6 score was the mean of the scores of all 6 questions and therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), with higher scores indicated lower asthma control. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, prior surgery, and regions as covariates.|Baseline, Week 24|Analysis was performed on a subset of participants which included all randomized participants with asthma and had available data for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547093|NCT02912468|Secondary|Change From Baseline at Week 24 in Forced Expiratory Volume in 1 Second (FEV1) for Participants With Asthma|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates.|Baseline, Week 24|Analysis was performed on a subset of participants which included all randomized participants with asthma.|||liters||Standard Error|Least Squares Mean
2547094|NCT02912468|Secondary|Change From Baseline at Week 24 in Rhinorrhea Daily Symptom Score|Rhinorrhea was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), where higher scores indicated more severe symptoms. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.|Baseline, Week 24|The analysis was performed on ITT population.|||score on a scale||Standard Error|Least Squares Mean
2547095|NCT02912468|Secondary|Change From Baseline at Week 24 in Nasal Peak Inspiratory Flow (NPIF)|NPIF evaluation represented a physiologic measure of the air flow through both nasal cavities during forced inspiration expressed in liters per minute. Higher NPIF values are indicative of better nasal air flow. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.|Baseline, Week 24|The analysis was performed on ITT population.|||liters per minute||Standard Error|Least Squares Mean
2547096|NCT02912468|Secondary|Change From Baseline at Week 24 in Visual Analogue Scale (VAS) for Rhinosinusitis|"The VAS for rhinosinusitis was used to evaluate the total disease severity. The participants were asked to indicate on a 10 centimeters (cm) VAS the answer to the question, How troublesome are your symptoms of your rhinosinusitis? The range of the VAS was from 0 (not troublesome) to 10 (worse thinkable troublesome), where higher score indicated worse thinkable troublesome. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates."|Baseline, Week 24|The analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||centimeters||Standard Error|Least Squares Mean
2547097|NCT02912468|Secondary|Rescue Treatment Use: Estimate of Percentage of Participants With >=1 Event by Week 24 Obtained Using Kaplan-Meier Method|"Rescue treatment was defined as usage of systemic corticosteroids (SCS) or NP surgery (actual or planned) during the treatment period. Rescue treatment included:~SCS: Betamethasone, dexamethasone, dexamethasone sodium phosphate, Hydrocortisone sodium succinate, methylprednisolone, prednisolone, prednisolone metasulfobenzoate sodium, prednisone, and triamcinolone.~Sino-nasal surgery for nasal polyps when there was worsening of signs and/or symptoms during the study.~Estimate of percentage of participants with event by Week 24 was obtained using Kaplan-Meier method."|Baseline up to Week 24|The analysis was performed on ITT population.|||percentage of participants with event||95% Confidence Interval|Number
2547098|NCT02912468|Secondary|Change From Baseline at Week 24 in 22-item Sino-nasal Outcome Test (SNOT-22) Scores|The SNOT-22 is a validated questionnaire that was used to assess the impact of chronic rhinosinusitis phenotype with nasal polyps (CRSwNP) on health-related quality of life (HRQoL). It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview.|Baseline, Week 24|The analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547099|NCT02912468|Secondary|Change From Baseline at Week 24 in Severity of Decreased/Loss of Smell as Assessed by Participant Daily|The severity of decreased/loss of sense of smell was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), higher score indicated more severe symptoms. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview.|Baseline, Week 24|The analysis was performed on ITT population.|||score on a scale||Standard Error|Least Squares Mean
2547117|NCT02912195|Secondary|Pain Relief at 20 Minutes Compared to Baseline.|Pain numeric rating scale (NRS) at 0 minutes minus pain NRS at 20 minutes. NRS is a scale ranging from 0, no pain, to 10 worst pain.|at 20 minutes||||units on a scale||95% Confidence Interval|Mean
2547101|NCT02912468|Secondary|Change From Baseline at Week 24 in Total Symptom Score (TSS)|The TSS was the sum of participant-assessed nasal symptom scores for nasal congestion/obstruction, decreased/loss of sense of smell, and rhinorrhea (anterior/posterior nasal discharge), each accessed on 0-3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms). Total score ranged from 0 (no symptoms) to 9 (severe symptoms). Higher score indicated more severe symptoms. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview.|Baseline, Week 24|The analysis was performed on ITT population.|||score on a scale||Standard Error|Least Squares Mean
2547102|NCT02912468|Secondary|Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund-Mackay (LMK) Score|The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. NOTE: For Japan regulatory submission only, this endpoint is not included as a secondary outcome measure and is instead one of the co-primary outcome measures.|Baseline, Week 24|The analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547103|NCT02912468|Primary|Change From Baseline at Week 24 in Nasal Polyp Score|NPS: sum of right, left nostril scores, evaluated by nasal endoscopy. For each nostril, NPS was graded based on polyp size from 0 = no polyps to 4 = large polyps causing complete obstruction of inferior nasal cavity; lower score = smaller-sized polyps. Total NPS: sum of right and left nostril scores; ranges from 0 (no polyps) to 8 (large polyps), higher score = more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview.|Baseline, Week 24|The analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547104|NCT02912468|Primary|Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score|NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Least squares (LS) means and standard error (SE) were obtained from Analysis of covariance (ANCOVA) model described in Statistical Analysis Overview.|Baseline, Week 24|The analysis was performed on intent-to-treat (ITT) population which included all randomized participants who were analyzed according to the treatment group allocated by randomization.|||score on a scale||Standard Error|Least Squares Mean
2547105|NCT02912364|Secondary|Profile of Mood States (POMS) Score.|"Participants were asked to rate the extent to which they feel a variety of emotions/feelings. The overall score is presented.~Assessments were performed prior to treatment (non-drug condition average) and at the end of each treatment period. Score range: -32 to 200. Lower scores correspond to better mood state."|Prior to treatment (non-drug condition average) and at the end of each six-week treatment period.|Participants who completed the protocol are included in the analysis. That is, participants who completed both treatment arms (Eslicarbazepine and Carbamazepine) are included in the analysis.|||units on a scale||Standard Deviation|Mean
2547106|NCT02912364|Secondary|Dual Task Percent of Time in Box.|"Participants were asked to use their computer mouse to keep the cursor inside a moving box on the computer screen while simultaneously responding with a button press when a number on the screen exceeded a certain value.~Assessments were performed prior to treatment (non-drug condition average) and at the end of each treatment period."|Prior to treatment (non-drug condition average) and at the end of each six-week treatment period.|Participants who completed the protocol are included in the analysis. That is, participants who completed both treatment arms (Eslicarbazepine and Carbamazepine) are included in the analysis.|||percentage of time in box||Standard Deviation|Mean
2547107|NCT02912364|Secondary|MCG Paragraph Recall Scores.|"Participants were read a paragraph and were asked to recall content immediately following and twenty minutes after hearing the reading. MCG = Medical College of Georgia.~Assessments were performed prior to treatment (non-drug condition average) and at the end of each treatment period. Score range: 0 - 60, higher scores indicate better memory function."|Prior to treatment (non-drug condition average) and at the end of each six-week treatment period.|Participants who completed the protocol are included in the analysis. That is, participants who completed both treatment arms (Eslicarbazepine and Carbamazepine) are included in the analysis.|||units on a scale||Standard Deviation|Mean
2547108|NCT02912364|Secondary|Overall Z-score for Executive Function.|Executive function consists of a composite of measures from the computerized cognitive tests. The Z-score indicates the number of standard deviations away from a reference population. A Z-score of 0 is equal to the mean. Negative numbers indicate poor cognitive performance compared to the mean and positive numbers represent higher cognitive performance compared to the mean.|At the end of each 6-week drug treatment period.|Participants who completed the protocol are included in the analysis. That is, participants who completed both treatment arms (Eslicarbazepine and Carbamazepine) are included in the analysis.|||Z-score||Standard Deviation|Mean
2547109|NCT02912364|Primary|Overall Composite Z Score of Neuropsychological Battery as a Measure of Direct Comparison of the 2 Antiepileptic Drugs.|Z score of cognitive tests at end of each 6-week drug treatment period for each intervention (i.e., Eslicarbazepine and Carbamazepine). The Z-score indicates the number of standard deviations away from a reference population. A Z-score of 0 is equal to the mean. Negative numbers indicate poor cognitive performance compared to the mean and positive numbers represent higher cognitive performance compared to the mean.|At the end of each 6-week drug treatment period.|Participants who completed the protocol are included in the analysis. That is, participants who completed both treatment arms (completed treatment 2 in the participant flow) are included in the analysis.|||Z-score||Standard Deviation|Mean
2547110|NCT02912195|Secondary|Number of Participants Reporting Adverse Events|Participants will be observed for the following adverse events and side effects: seizure, bradyarrhythmias, hyper or hypotension, perioral numbness, tinnitus, metallic taste, other, hypotension, hypoxia, nausea, vomiting, itching, or other side effects. Participants have the opportunity to report other side effects during the study|0-60 minutes||||Participants|||Count of Participants
2547125|NCT02911948|Secondary|Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: EuroQol-5D (EQ-5D-5L) Questionnaire|"Overall health state was rated by patients using the EQ-5D-5L visual analogue scale (VAS) and the EQ-5D-5L index score. The EQ-5D-5L VAS is a vertical scale where patients can rank their health from 0 (worst health imaginable) to 100 (best health imaginable).~The EQ-5D-5L index score was calculated based on the 5 dimensions, i.e., mobility, self-care, usual activities (e.g., work, study), pain/discomfort and anxiety/depression with five response levels for each dimension, i.e., no problems, slight problems, moderate problems, severe problems and extreme problems. The scores from 5 dimensions are then converted to the EQ-5D-5L index score scale: 0 - 1 (full health/best-case response = 1; death/worst-case response = 0)."|week 0, week 26|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Score on a scale||Standard Deviation|Mean
2547126|NCT02911948|Secondary|Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: Diabetes Therapy-Related Quality of Life (DTR-QOL)Questionnaire|"For the DTR-QOL questionnaire, change from baseline in the 'Total score' and the following four 'Domain scores' were analysed:~Burden on social activities and daily activities~Anxiety and dissatisfaction with treatment~Hypoglycaemia~Satisfaction with treatment. The scoring range of 'Total score' was converted to 0-100 (best case response = 100; worst case response = 0).~The scoring range for each of four domains was converted to 0-100 (best case response = 100; worst case response = 0)."|week 0, week 26|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Score on a scale||Standard Deviation|Mean
2547127|NCT02911948|Secondary|Change in Pulse|Change in pulse after 26 weeks of treatment.|Week 0, week 26|Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (210 subjects). Missing data were imputed using last observation carried forward (LOCF) method.|||beats per minute||Standard Deviation|Mean
2547128|NCT02911948|Secondary|Change in Clinical Evaluation: Electrocardiogram (ECG)|The result of the ECG was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' ECG results at screening (week -2 to week 0) and week 26.|Screening (week -2 to week 0), week 26|"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (210 subjects). Subjects in the safety set contributed to the evaluation as treated. Missing data were imputed using last observation carried forward (LOCF) method."|||Participants|||Count of Participants
2547129|NCT02911948|Secondary|Change in Clinical Evaluation: Fundoscopy or Fundus Photography|The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at screening (week -2 to week 0) and week 26.|Screening (week -2 to week 0), week 26|"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (210 subjects). Subjects in the safety set contributed to the evaluation as treated. Missing data were imputed using last observation carried forward (LOCF) method."|||Participants|||Count of Participants
2547130|NCT02911948|Secondary|Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes|"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. Nocturnal period: The period between 00:01 and 05:59 a.m. (both inclusive).~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.~Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration."|During 26 weeks of treatment|"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (210 subjects). Subjects in the safety set contributed to the evaluation as treated."|||Number of episodes|||Number
2547131|NCT02911948|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition|"Results represent total number of treatment emergent hypoglycaemic episodes that fall under ADA's definition of hypoglycaemia. ADA's definition of hypoglycaemia includes following categories:~Severe hypoglycaemia~Documented symptomatic hypoglycaemia~Asymptomatic hypoglycaemia~Probable symptomatic hypoglycaemia~Pseudo-hypoglycaemia. Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product."|During 26 weeks of treatment|"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (210 subjects). Subjects in the safety set contributed to the evaluation as treated."|||Number of episodes|||Number
2547166|NCT02911909|Secondary|International Knee Documentation Committee (IKDC) Survey Score|"Compare the mean International Knee Documentation Committee (IKDC) survey score between the delfi and the control group The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Meanwhile, the sports activity subscale focuses on functions like going up and down the stairs, rising from a chair, squatting and jumping. The knee function subscale asks patients one simple question: how is their knee at present versus how was their knee prior to injury?~Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function."|12 months|No patient in the Delfi group complete the 12 months evaluation / No data obtained in the Delfi group|||score on a scale||Standard Deviation|Mean
2547132|NCT02911948|Secondary|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes|"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.~Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration."|During 26 weeks of treatment|"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (210 subjects). Subjects in the safety set contributed to the evaluation as treated."|||Number of episodes|||Number
2547133|NCT02911948|Secondary|Number of Treatment Emergent Adverse Events (TEAE)|Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.|During 26 weeks of treatment|"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (210 subjects). Subjects in the safety set contributed to the evaluation as treated."|||Number of events|||Number
2547134|NCT02911948|Secondary|Fasting Lipid Profile|Lipid profile includes total cholesterol, low density lipoprotein cholesterol (LDL cholesterol), high density lipoprotein cholesterol (HDL cholesterol), very low density lipoprotein cholesterol (VLDL cholesterol), triglycerides and free fatty acids. Lipid profile parameters are represented as ratio to baseline values.|Week 0, week 26|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method. Number analyzed = subjects with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2547135|NCT02911948|Secondary|Change in SMBG 9-point Profile: Mean of Postprandial Plasma Glucose Increments (From Before Meal to 90 Minutes After Breakfast, Lunch and Dinner)|Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. The mean increment over all meals was derived as the mean of all available meal increments.|Week 0, week 26|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||mmol/L||Standard Deviation|Mean
2547136|NCT02911948|Secondary|Change in SMBG 9-point Profile: Mean of the 9-point Profile|Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. Mean of the 9-point profile was defined as the area under the profile (calculated using the trapezoidal method) divided by the measurement time.|Week 0, week 26|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.|||mmol/L||Standard Deviation|Mean
2547137|NCT02911948|Secondary|Self-measured Blood Glucose (SMBG) 9-point Profile (Individual Points in the Profile)|Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day.|After 26 weeks|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.|||mmol/L||Standard Deviation|Mean
2547138|NCT02911948|Secondary|Change in Blood Pressure (Systolic and Diastolic)|Change from baseline in blood pressure (systolic and diastolic) after 26 weeks of treatment.|week 0, week 26|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||mmHg||Standard Deviation|Mean
2547139|NCT02911948|Secondary|Change in Waist Circumference|Change from baseline (week 0) in waist circumference after 26 weeks of treatment.|week 0, week 26|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||cm||Standard Deviation|Mean
2547167|NCT02911909|Secondary|Patient-Reported Outcomes Measurement Information System (PROMIS) Survey Score.|"Compare the mean Patient-Reported Outcomes Measurement Information System Global Physical health row score (PROMIS) between the Delfi and the control group.~PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. The Score is represented in a 0 to 100 scale. Zero is the worst possible outcome and 100 is teh best possible outcome"|12 months|No patient in the Delfi group complete the 12 months evaluation / No data obtained in the Delfi group|||score on a scale||Standard Deviation|Mean
2547289|NCT02909140|Secondary|Pupil Size on Post-operative Day 1||Post-operative Day 1|Data not available because it wasn't collected||||||
2547140|NCT02911948|Secondary|Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment|"Number of subjects with HbA1c less than or equal to 6.5% and no weight gain after 26 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia."|After 26 weeks|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.|||Participants|||Count of Participants
2547141|NCT02911948|Secondary|Responder (Yes/no): HbA1c Less Than or Equal to 6.5% Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment|"Number of subjects with HbA1c less than or equal to 6.5% after 26 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia."|After 26 weeks|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.|||Participants|||Count of Participants
2547142|NCT02911948|Secondary|Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain|Number of subjects with HbA1c less than or equal to 6.5% and without weight gain|After 26 weeks|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Participants|||Count of Participants
2547143|NCT02911948|Secondary|Responder (Yes/no): HbA1c Less Than or Equal to 6.5%|Number of subjects with HbA1c less than or equal to 6.5% after 26 weeks.|After 26 weeks|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Participants|||Count of Participants
2547144|NCT02911948|Secondary|Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment|"Number of subjects with HbA1c less than 7.0% and no weight gain after 26 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia."|After 26 weeks|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.|||Participants|||Count of Participants
2547145|NCT02911948|Secondary|Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment|"Number of subjects with HbA1c less than 7.0% after 26 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia."|After 26 weeks|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.|||Participants|||Count of Participants
2547146|NCT02911948|Secondary|Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain|Number of subjects with HbA1c less than 7.0% and without weight gain after 26 weeks.|After 26 weeks|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Participants|||Count of Participants
2547147|NCT02911948|Secondary|Responder (Yes/no): HbA1c Less Than 7.0%|Number of subjects with HbA1c less than 7.0% after 26 weeks.|After 26 weeks|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Participants|||Count of Participants
2547148|NCT02911948|Secondary|Daily Insulin Dose|Actual daily total insulin dose after 26 weeks.|After 26 weeks|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Units||Standard Deviation|Mean
2547149|NCT02911948|Secondary|Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes|"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.~Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration."|During 26 weeks of treatment|"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (210 subjects). Subjects in the safety set contributed to the evaluation as treated."|||Number of episodes|||Number
2547150|NCT02911948|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline (week 0) in FPG after 26 weeks of treatment.|week 0, week 26|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||mmol/L||Standard Deviation|Mean
2547151|NCT02911948|Secondary|Change in Body Weight|Change from baseline (week 0) in body weight after 26 weeks of treatment.|week 0, week 26|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Kg||Standard Deviation|Mean
2547152|NCT02911948|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline (week 0) in HbA1c after 26 weeks of treatment.|week 0, week 26|Full Analysis Set (FAS) included all randomised subjects (210 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Percentage of HbA1c||Standard Deviation|Mean
2547153|NCT02911922|Other Pre-specified|Comparing Neutrophile:Lymphocyte Ratio (NLR) at Different Time Points to Assess Impact of SBRT in All the Participants|Comparing NLR ratio at different timepoints to assess the impact of radiation therapy on patients. A neutrophil:lymphocyte ratio (NLR) > 4 at time radiotherapy predicts for significantly worse prognosis, when compared to NLR < 4.|1 month, 6 months, 1 year|Data was not collected for the Rectal Spacer – Radiation Therapy arm because the trial was terminated due to lack of accrual.|||ratio|||Number
2547154|NCT02911922|Other Pre-specified|Measuring Number of Participants Changes in the Microbiome That is Associated With Normal Tissue Toxicities Resulting From Radiation From Baseline to End of Treatment|To explore microbiome changes associated with normal tissue toxicities resulting from radiation|baseline, post radiation follow up|Data was not collected for both Endorectal balloon arm and the Rectal Spacer – Radiation Therapy arm.||||||
2547155|NCT02911922|Secondary|Incidence of Patient-reported Toxicity (Late Toxicity) Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4|To compare late toxicity (as defined by CTCAE v4.0). Late toxicities are toxicities that occur greater than 3 months after radiation therapy completion.|post RT to 1 year|Data was not collected for the Rectal Spacer – Radiation Therapy arm because the trial was terminated due to lack of accrual.|||Participants|||Count of Participants
2547156|NCT02911922|Secondary|Comparing Several Parameters That Are Involved in Treatment Planning in Patients Randomized to Two Radiation Therapy Modalities.|"To compare the dose distribution of the 2 techniques, specifically:~coverage of the PTV~DVH of organs at risk (OAR)~prostate motion and shifts required during treatment"|5 years|Data could not be analyzed for the secondary outcome measure as we needed more than one patient to compare two radiation techniques. The trial was terminated due to lack of accrual.||||||
2547157|NCT02911922|Secondary|Number of Participants With Recurrence-free Survival|1 year|1 year|Data was not collected for the Rectal Spacer – Radiation Therapy arm because the trial was terminated due to lack of accrual.|||Participants|||Count of Participants
2547158|NCT02911922|Secondary|Measure the Effect of Treatment on Patients' Using Health Related Quality of Life Based on Expanded Prostate Cancer Index Composite Questionnaire|To compare health-related quality of life (HRQOL) measured using the Expanded Prostate Cancer Index Composite (EPIC) instrument for bowel, urinary and sexual domains. scores are transformed linearly to a 0-100 scale (see following page: EPIC scoring), with higher scores representing better HRQOL. American Urological Association (AUA) scores ranges from 0-30 scores where, score greater than 15 indicate high degree of urinary symptoms and scores less than 15 indicate low degree of urinary symptoms.|1 year|Data was not collected for the Rectal Spacer - Radiation Therapy arm because the trial was terminated due to lack of accrual.|||units on a scale|||Number
2547159|NCT02911922|Primary|Incidence of Patient-reported Acute Toxicity Based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4|To compare acute toxicity (as defined by CTCAE v4.0) and to compare Rectal dose (V35, max rectal dose). Acute radiation toxicities are side effects that occur on treatment or in the immediate post treatment period (within 90 days from the start of radiation treatment).|Baseline to 1 year|Data was not collected for the Rectal Spacer – Radiation Therapy arm because the trial was terminated due to lack of accrual.|||Participants|||Count of Participants
2547160|NCT02911909|Secondary|IGF Level|Compare the mean IGF blood values between delfi and control group|12 months|samples were not processed due to study termination||||||
2547161|NCT02911909|Secondary|HGH Level|Compare mean HGH blood levels between the delfi and the control group|12 months|Samples were not processed due to study termination||||||
2547162|NCT02911909|Secondary|CK Level|Compare CK levels at 12 months between delfi and control group|12 months|Samples were not processed due to study termination||||||
2547163|NCT02911909|Secondary|KT-2000 Anterior Tibial Translation|Compare the mean anterior translation of the tibia between delfi and control groups anterior translation was measured using a KT-2000 device|12 months|No patient in the Delfi group complete the 12 months evaluation / No data obtained in the Delfi group|||milimiters||Standard Deviation|Mean
2547168|NCT02911909|Secondary|Tegner Activity Survey Score|"Compare the Tegner Activity Survey score mean between the Delfi and the control group.~Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. The score varies from 0-10. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports >6 score can only be achieved if the person participates in recreational or competitive sport."|12 months|No patient in the Delfi group complete the 12 months evaluation / No data obtained in the Delfi group|||score on a scale||Standard Deviation|Mean
2547169|NCT02911909|Secondary|Range of Motion|Compare the total Range of motion of the involved leg at 12 months between the Delfi and the control group|12 months|No patient in the Delfi group complete the 12 months evaluation / No data obtained in the Delfi group|||Degrees||Standard Deviation|Mean
2547170|NCT02911909|Primary|Muscle Strength|Compare mean peak muscle strength at 60 degrees of knee flexion (during extension) of the involved leg between the blood restriction and the control groups|12 months|No Subjects in the Deflfi group completed the muscle strength evaluation at 12 months|||FT-LBS||Standard Deviation|Mean
2547171|NCT02911857|Primary|Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths|Participants were monitored for safety throughout the study.|Participants were followed for the duration until approval, an expected average of 3 months.|Safety set: The safety set included all participants who were treated in this extension study.|||Participants|||Count of Participants
2547172|NCT02911844|Primary|Change From Baseline of Plasma NT-proBNP Level|"Plasma NT-proBNP levels are obtained and measured from blood samples collected from each participant.~Difference in change from baseline to 9 weeks in plasma NT-proBNP levels"|Baseline to 9 weeks||||pg/ml||Inter-Quartile Range|Median
2547173|NCT02911844|Primary|Change From Baseline of Six Minute Walk Distance|Measure obtained from six minute walk test completed by participants Difference in change from baseline to 9 weeks in the six minute walk test distance|Baseline to 9 weeks||||meters||Inter-Quartile Range|Median
2547174|NCT02911844|Primary|Change From Baseline of Tricuspid Annular Plane Systolic Excursion (TAPSE)|Measure obtained from echocardiogram completed on participants Difference in change from baseline to 9 weeks in TAPSE|Baseline to 9 weeks||||millimeter||Inter-Quartile Range|Median
2547175|NCT02911844|Primary|Change From Baseline of Plasma Estradiol Levels|"Plasma estradiol levels are obtained and measured from blood samples collected from each participant.~Difference in change from baseline to 9 weeks in plasma estradiol levels"|Baseline to 9 weeks||||pg/ml||Inter-Quartile Range|Median
2547176|NCT02911818|Secondary|Extension Study Secondary Outcome: Patient Health Questionnaire (PHQ-9)|PHQ-9 is scored based on a 0-27 scale in which higher scores indicate more severe depression. Values are summed to compute the total score.|Re-randomization and 12 weeks||||score on a scale||Standard Error|Mean
2547177|NCT02911818|Secondary|Extension Study Secondary Outcome: SF-36 - Mental Health Component|"All sub scales are scored from 0 - 100, with higher scores indicating better health. Each component summary is a normed score with a mean of 50 and standard deviation of 10 in the US general population. Higher scores indicate better health.~Z-scores are computed for each subscale, which are then converted into a component summary z-score using a weighted formula. The component summary z-score is then converted to a t-distribution with a mean of 50 and standard deviation of 10.~Scores are scaled to a T-score with a mean of 50 and standard deviation of 10. Scores above 50 indicate better health."|Re-randomization and 12 weeks||||T scores||Standard Error|Mean
2547178|NCT02911818|Secondary|Extension Study Secondary Outcome: SF-36 - Physical Health Component|"All sub scales are scored from 0 - 100, with higher scores indicating better health. Each component summary is a normed score with a mean of 50 and standard deviation of 10 in the US general population. Higher scores indicate better health.~Z-scores are computed for each subscale, which are then converted into a component summary z-score using a weighted formula. The component summary z-score is then converted to a t-distribution with a mean of 50 and standard deviation of 10.~Scores are scaled to a T-score with a mean of 50 and standard deviation of 10. Scores above 50 indicate better health."|Re-randomization and 12 weeks||||T scores||Standard Error|Mean
2547179|NCT02911818|Secondary|Extension Study Secondary Outcome: Change in HOMA-IR|HOMA-IR is a measurement for insulin resistance and is calculated from: fasting insulin (U/L) x fasting glucose (mg/dL)/405. A decrease from baseline to the end of treatment, a negative value, indicates an improvement|Re-randomization and 12 weeks||||mg/dL*µIU/mL/405||Standard Error|Mean
2547180|NCT02911818|Secondary|Extension Study Secondary Outcome: Change in Fasting Insulin||Re-randomization and 12 weeks||||uIU/mL||Standard Error|Mean
2547181|NCT02911818|Secondary|Extension Study Secondary Outcome: Change in HbA1c||Re-randomization and 12 weeks||||percentage||Standard Error|Mean
2547182|NCT02911818|Secondary|Extension Study Secondary Outcome: Change in Fasting Glucose||Re-randomization and 12 weeks||||mg/dL||Standard Error|Mean
2547183|NCT02911818|Secondary|Extension Study Secondary Outcome: Change in c-Reactive Protein||Re-randomization and 12 weeks||||mg/L||Standard Error|Mean
2547184|NCT02911818|Secondary|Extension Study Secondary Outcome: Change in Triglycerides||Re-randomization and 12 weeks||||mg/dL||Standard Error|Mean
2547185|NCT02911818|Secondary|Extension Study Secondary Outcome: Change in HDL Cholesterol||Re-randomization and 12 weeks||||mg/dL||Standard Error|Mean
2547186|NCT02911818|Secondary|Extension Study Secondary Outcome: Change in LDL Cholesterol||Re-randomization and 12 weeks||||mg/dL||Standard Error|Mean
2547187|NCT02911818|Secondary|Extension Study Secondary Outcome: Change in Total Cholesterol||Re-randomization and 12 weeks||||mg/dL||Standard Error|Mean
2547188|NCT02911818|Secondary|Extension Study Secondary Outcome: Change in Waist Circumference||Re-randomization and 12 weeks||||cm||Standard Error|Mean
2547189|NCT02911818|Secondary|Extension Study Secondary Outcome: Change in Heart Rate||Re-randomization and 12 weeks||||Beats per minute||Standard Error|Mean
2547190|NCT02911818|Secondary|Extension Study Secondary Outcome: Change in Diastolic Blood Pressure||Re-randomization and 12 weeks||||mm Hg||Standard Error|Mean
2547191|NCT02911818|Secondary|Extension Study Secondary Outcome: Change in Systolic Blood Pressure||Re-randomization and 12 weeks||||mm Hg||Standard Error|Mean
2547193|NCT02911818|Secondary|Change 36-Item Short Form Survey (SF-36) - Mental Component Summary|"All sub scales are scored from 0 - 100, with higher scores indicating better health. Each component summary is a normed score with a mean of 50 and standard deviation of 10 in the US general population. Higher scores indicate better health.~Z-scores are computed for each subscale, which are then converted into a component summary z-score using a weighted formula. The component summary z-score is then converted to a t-distribution with a mean of 50 and standard deviation of 10.~Scores are scaled to a T-score with a mean of 50 and standard deviation of 10. Scores above 50 indicate better health."|Randomization and 52 weeks||||T scores||Standard Error|Mean
2547194|NCT02911818|Secondary|Change in 36-Item Short Form Survey (SF-36) - Physical Component Summary|"All sub scales are scored from 0 - 100, with higher scores indicating better health. Each component summary is a normed score with a mean of 50 and standard deviation of 10 in the US general population. Higher scores indicate better health.~Z-scores are computed for each subscale, which are then converted into a component summary z-score using a weighted formula. The component summary z-score is then converted to a t-distribution with a mean of 50 and standard deviation of 10.~Scores are scaled to a T-score with a mean of 50 and standard deviation of 10. Scores above 50 indicate better health."|Randomization and 52 weeks||||T scores||Standard Error|Mean
2547195|NCT02911818|Secondary|Change in HOMA-IR|HOMA-IR is a measurement for insulin resistance and is calculated from: fasting insulin (U/L) x fasting glucose (mg/dL)/405. A decrease from baseline to the end of treatment, a negative value, indicates an improvement|Randomization and 52 weeks||||mg/dL*µIU/mL/405||Standard Error|Mean
2547196|NCT02911818|Secondary|Change in Fasting Insulin||Randomization and 52 weeks||||uIU/mL||Standard Error|Mean
2547197|NCT02911818|Secondary|Change in HbA1c||Randomization and 52 weeks||||percentage||Standard Error|Mean
2547198|NCT02911818|Secondary|Change in Fasting Glucose||Randomization and 52 weeks||||mg/dL||Standard Error|Mean
2547199|NCT02911818|Secondary|Change in C Reactive Protein||Randomization and 52 weeks||||mg/L||Standard Error|Mean
2547200|NCT02911818|Secondary|Change in Triglycerides||Randomization and 52 weeks||||mg/dL||Standard Error|Mean
2547201|NCT02911818|Secondary|Change in HDL Cholesterol||Randomization and 52 weeks||||mg/dL||Standard Error|Mean
2547202|NCT02911818|Secondary|Change in LDL Cholesterol||Randomization and 52 weeks||||mg/dL||Standard Error|Mean
2547203|NCT02911818|Secondary|Change in Total Cholesterol||Randomization and 52 weeks||||mg/dL||Standard Error|Mean
2547204|NCT02911818|Secondary|Change in Waist Circumference||Randomization and 52 weeks||||cm||Standard Error|Mean
2547205|NCT02911818|Secondary|Change in Heart Rate||Randomization and 52 weeks||||Beats per minute||Standard Error|Mean
2547206|NCT02911818|Secondary|Change in Diastolic Blood Pressure||Randomization and 52 weeks||||mm Hg||Standard Error|Mean
2547207|NCT02911818|Secondary|Change in Systolic Blood Pressure||Randomization and 52 weeks||||mm Hg||Standard Error|Mean
2547208|NCT02911818|Primary|Extension Study Primary Outcome: Percent Change in Re-randomization Weight||Re-randomization and 12 weeks||||percent change||Standard Error|Mean
2547209|NCT02911818|Primary|Percent Change in Baseline Weight||Randomization and 52 weeks||||percent change||Standard Error|Mean
2547210|NCT02911753|Secondary|Change in Body Weight (Baseline and Week 6)|Body weight was measured on a digital scale to assess change in body weight over the intervention period.|Baseline and Week 6||||kg||95% Confidence Interval|Mean
2547211|NCT02911753|Secondary|Change in Hemoglobin A1C (Baseline and Week 6)|Fasting blood samples (venipuncture) were collected for the purpose of examining changes in hemoglobin A1C.|Baseline and Week 6||||% of Hemoglobin A1C||95% Confidence Interval|Mean
2547212|NCT02911753|Secondary|Change in Fasting Glucose (Baseline and Week 6)|Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in glucose.|Baseline and Week 6||||mg/dl||95% Confidence Interval|Mean
2547213|NCT02911753|Secondary|Change in Total Cholesterol (Baseline and Week 6)|Fasting blood samples (venipuncture) will be collected for the purpose of examining changes in total cholesterol.|Baseline and Week 6||||mg/dl||95% Confidence Interval|Mean
2547214|NCT02911753|Primary|Treatment Satisfaction|Participants will be asked to rate their overall satisfaction (1- low; 4-high) with the intervention for changing dietary patterns at Week 6 and if they would recommend the program to others.|Week 6||||units on a scale||Standard Deviation|Mean
2547215|NCT02911753|Primary|Retention|Retention will be measured as the number of participants who remain in the study at 6 weeks.|Week 6||||Participants|||Count of Participants
2547216|NCT02911753|Primary|Enrollment|The number of Hispanic adults enrolled in the study.|Baseline||||Participants|||Count of Participants
2547217|NCT02911753|Primary|Study Recruitment: Ineligibility|The number of Hispanic adults ineligible for study inclusion.|Baseline||||Participants|||Count of Participants
2547218|NCT02911753|Primary|Study Recruitment: Eligibility|The number of Hispanic adults eligible for study inclusion.|Baseline||||Participants|||Count of Participants
2547219|NCT02911753|Primary|Study Recruitment: Screened for Eligibility|The number of Hispanic adults screened for eligibility|Baseline||||Participants|||Count of Participants
2547220|NCT02911753|Primary|Study Recruitment: Interest in Participation|The number of Hispanic adults who contact the researchers and express interest in participation.|Baseline||||Participants|||Count of Participants
2547221|NCT02911688|Post-Hoc|Change in Central Lung Clearance of Technetium Sulfur Colloid Particles (0-30 Minutes) From Baseline Following Ozone Exposure|Central lung clearance (0-30 minutes) was measured using gamma scintigraphy and represented as mean average 30 minute clearance of inhaled technetium (99mTc) sulfur colloid particles from the large bronchial airways.|baseline and 1 hour after exiting ozone chamber|This population includes those participants who completed both arms of the study (paired assessments of MCC). One participant could not complete the whole lung clearance scan during one of the study periods and was excluded from the analysis.|||% clearance||Standard Deviation|Mean
2547278|NCT02909153|Primary|Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intravenous Administration of Triferic|The PK will be done by assessing the mean absolute Cmax of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours||||micrograms/ deciliters||Geometric Coefficient of Variation|Geometric Mean
2547222|NCT02911688|Secondary|Change in Whole Lung Clearance of Technetium Sulfur Colloid Particles (0-120 Minutes) From Baseline Following Ozone Exposure|Whole lung clearance was measured using gamma scintigraphy and represented as mean average 120 minute clearance of inhaled technetium (99mTc) sulfur colloid particles in order to estimate the rate of airway mucociliary clearance.|baseline and 1 hour after exiting ozone chamber|This population includes those participants who completed both arms of the study (paired assessments of MCC). One participant could not complete the whole lung clearance scan during one of the study periods and was excluded from the analysis.|||% clearance||Standard Deviation|Mean
2547223|NCT02911688|Secondary|Change in Sputum Mucins From Baseline Following Ozone Exposure|Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of sputum mucins to determine if gamma tocopherol pre-treatment reduces ozone-induced sputum mucins compared to placebo pre-treatment.|baseline and 6 hours post ozone exposure|Due to improper processing of the sputum samples, analysis of mucins could not be performed.||||||
2547224|NCT02911688|Secondary|Change in Sputum Tumor Necrosis Factor (TNF)-Alpha From Baseline Following Ozone Exposure|Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cytokines. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum inflammatory cytokine production compared to placebo pre-treatment.|baseline and 6 hours post ozone exposure|Sufficient paired sputum supernatants from pre and post-ozone were available for analysis from 13 volunteers.|||picograms per milliliter||Standard Deviation|Mean
2547225|NCT02911688|Secondary|Change in Sputum IL-8 From Baseline Following Ozone Exposure|Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cytokines. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum inflammatory cytokine production compared to placebo pre-treatment.|baseline and 6 hours post ozone exposure|Sufficient paired sputum supernatants from pre and post-ozone were available for analysis from 12 volunteers.|||picograms per milliliter||Standard Deviation|Mean
2547226|NCT02911688|Secondary|Change in Sputum IL-6 From Baseline Following Ozone Exposure|Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cytokines. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum inflammatory cytokine production compared to placebo pre-treatment.|baseline and 6 hours post ozone exposure|Sufficient paired sputum supernatants from pre and post-ozone were available for analysis from 15 volunteers.|||picograms per milliliter||Standard Deviation|Mean
2547227|NCT02911688|Secondary|Change in Sputum Interleukin (IL)-1b From Baseline Following Ozone Exposure|Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cytokines. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum inflammatory cytokine production compared to placebo pre-treatment.|baseline and 6 hours post ozone exposure|Sufficient paired sputum supernatants from pre and post-ozone were available for analysis from 15 volunteers.|||picograms per milliliter||Standard Deviation|Mean
2547228|NCT02911688|Secondary|Change in Sputum Percent Eosinophils From Baseline Following Ozone Exposure|The investigators assessed induced sputum cellularity at baseline and 6 hours after ozone exposure to determine if treatment with gamma tocopherol/placebo impacts ozone-induced sputum eosinophilia.|baseline and 6 hours post-ozone exposure|Due to variability in quality of induced sputum samples, paired assessments of pre and post-ozone sputum endpoints were limited to 7 volunteers.|||percent eosinophils||Standard Deviation|Mean
2547229|NCT02911688|Primary|Change From Baseline in Sputum Percent Neutrophils (%PMN) Following Ozone Exposure|Participants provide induced sputum samples before and 6 hours after Ozone exposure for measurements of inflammatory cells. The analysis will determine if gamma tocopherol pre-treatment reduces ozone-induced sputum percent neutrophils compared to placebo pre-treatment.|baseline and 6 hours post-ozone exposure|Due to variability in quality of induced sputum samples, paired assessments of pre and post-ozone sputum endpoints were limited to 7 volunteers.|||percent neutrophils||Standard Deviation|Mean
2547230|NCT02911324|Secondary|Feasibility of Recruitment|Number of eligible participants recruited per month over a 1 year period.|Through study completion, an average of 1 year.|16 total participants were recruited for participation in this study|||participants per month|||Number
2547231|NCT02911324|Primary|Change in Yale-Brown Obsessive Compulsive Scale|"Yale-Brown Obsessive Compulsive Scale (YBOCS) Minimum Value: 0 Maximum Value: 40 Higher scores indicate more severe symptoms~Change in YBOCS is calculated by subtracting the Week 4 score from the baseline score"|Baseline (Week 0) and Week 4||||score on a scale||Standard Deviation|Mean
2547232|NCT02910739|Secondary|Number of Participants Discontinuing Study Due to an Adverse Event|The number of participants discontinuing study due to an AE was assessed. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening of a preexisting condition that is temporally associated with the use of the study treatment is also considered an AE.|Up to 14 days following MK-8931 40 mg administration.|All participants as treated, consisting of all participants receiving the single dose of MK-8931 40 mg.|||Participants|||Count of Participants
2547233|NCT02910739|Secondary|Number of Participants Experiencing an Adverse Event|The number of participants experiencing an adverse event (AE) was assessed. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening of a preexisting condition that is temporally associated with the use of the study treatment is also considered an AE.|Up to 14 days following MK-8931 40 mg administration.|All participants as treated, consisting of all participants receiving the single dose of MK-8931 40 mg.|||Participants|||Count of Participants
2547279|NCT02909153|Primary|Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) 0 - 12 of Serum Total Iron After Intraperitoneal Administration of Triferic|The PK will be done by assessing the AUC from time zero to 12 hours after infusion (AUC0-12) of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours||||hours x micrograms/ deciliters||Geometric Coefficient of Variation|Geometric Mean
2547290|NCT02909140|Secondary|Pupil Size Upon Completion of Surgery||intraoperative|"Data was only collected for the Intracameral Mydriasis' arm. We analyzed data for 1 participant only because of lack of data for the other participant."|||mm|||Number
2547234|NCT02910739|Primary|Apparent Volume of Distribution of MK-8931 During the Terminal Phase After Extravascular Administration (Vz/F)|Geometric mean apparent volume of distribution of MK-8931 during the terminal phase after extravascular administration (Vz/F) was assessed. Blood samples were collected at each pre-specified time point and plasma was isolated for analysis. Plasma MK-8931 concentration was then quantified at each time point to determine Vz/F, defined as the total amount of MK-8931 administered normalized to the bioavailability of MK-8931 in the plasma during the terminal phase following oral MK-8931 administration.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after MK-8931 40 mg dose|All participants who received the single dose of MK-8931 40 mg, complied with trial protocol, and had blood samples available for the evaluation of Vz/F. One participant with moderate HI discontinued study prior to collection of samples at 72, 96, and 120 hours post-dose and was excluded from analysis.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2547235|NCT02910739|Primary|Apparent Terminal Half-Life of MK-8931 (t1/2)|Geometric mean apparent terminal half-life (t1/2) of MK-8931 was assessed. Blood samples were collected at each pre-specified time point and plasma was isolated for analysis. Plasma MK-8931 concentration was then quantified at each time point to determine t1/2, defined as the time required for the plasma MK-8931 concentration to decrease to 50% of maximum.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after MK-8931 40 mg dose|All participants who received the single dose of MK-8931 40 mg, complied with trial protocol, and had blood samples available for the evaluation of t1/2. One participant with moderate HI discontinued study prior to collection of samples at 72, 96, and 120 hours post-dose and was excluded from analysis.|||hr||Geometric Coefficient of Variation|Geometric Mean
2547236|NCT02910739|Primary|Time to Maximum Observed MK-8931 Plasma Drug Concentration (Tmax)|Median time to maximum observed MK-8931 plasma drug concentration (Tmax) was assessed. Blood samples were collected at each pre-specified time point and plasma was isolated for analysis. Plasma MK-8931 concentration was then quantified at each time point to determine Tmax, defined as the amount of time required following MK-8931 administration for the plasma concentration of MK-8931 to reach maximum observed concentration.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours after MK-8931 40 mg dose|All participants who received the single dose of MK-8931 40 mg, complied with trial protocol, and had blood samples available for the evaluation of Tmax.|||hr||Full Range|Median
2547237|NCT02910739|Primary|Apparent Clearance of MK-8931 After Extravascular Administration (CL/F)|Geometric mean apparent clearance of MK-8931 after extravascular administration (CL/F) was assessed. Blood samples were collected at each pre-specified time point and plasma was isolated for analysis. Plasma MK-8931 concentration was then quantified at each time point to determine CL/F, defined as the rate of MK-8931 elimination normalized to the bioavailability of MK-8931 in the plasma following oral MK-8931 administration.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after MK-8931 40 mg dose|All participants who received the single dose of MK-8931 40 mg, complied with trial protocol, and had blood samples available for the evaluation of CL/F. One participant with moderate HI discontinued study prior to collection of samples at 72, 96, and 120 hours post-dose and was excluded from analysis.|||Liters/hr||Geometric Coefficient of Variation|Geometric Mean
2547238|NCT02910739|Primary|Plasma Concentration of MK-8931 at 24 Hours (C24hr)|Blood samples were collected 24 hours following oral dosing of MK-8931 and plasma was isolated for analysis. Plasma MK-8931 concentration was then quantified to determine C24hr, defined as the plasma concentration of MK-8931 at 24 hours after single oral dosing of MK-8931 40 mg. Individual C24hr values were ln-transformed and evaluated with an ANCOVA model containing a categorical factor for participant group (Moderate HI, Healthy Matched Control) and continuous covariates for age and BMI. This ANCOVA model was used to compute a geometric least-squares mean and 95% confidence interval for C24hr in each arm.|24 hours after MK-8931 40 mg dose|All participants who received the single dose of MK-8931 40 mg, complied with trial protocol, and had blood samples available for the evaluation of C24hr.|||nM||95% Confidence Interval|Geometric Least Squares Mean
2547239|NCT02910739|Primary|Area Under the Concentration Versus Time Curve of MK-8931 From 0 to 24 Hours (AUC0-24hr)|Blood samples were collected at each pre-specified time point and plasma was isolated for analysis. Plasma MK-8931 concentration was then quantified at each time point to determine AUC0-24hr, defined as the area under the MK-8931 concentration versus time curve from 0 (predose) until 24 hours after single oral dosing of MK-8931 40 mg. Individual AUC0-24hr values were ln-transformed and evaluated with an ANCOVA model containing a categorical factor for participant group (Moderate HI, Healthy Matched Control) and continuous covariates for age and BMI. This ANCOVA model was used to compute a geometric least-squares mean and 95% confidence interval for AUC0-24hr in each arm.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours after MK-8931 40 mg dose|All participants who received the single dose of MK-8931 40 mg, complied with trial protocol, and had blood samples available for the evaluation of AUC0-24hr.|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2547240|NCT02910739|Primary|Area Under the Concentration Versus Time Curve of MK-8931 From 0 to the Time of the Last Quantifiable (Above LLOQ) Sample (AUC0-last)|Blood samples were collected at each pre-specified time point and plasma was isolated for analysis. Plasma MK-8931 concentration was then quantified at each time point to determine AUC0-last, defined as the area under the MK-8931 concentration versus time curve from 0 (predose) to the time of the last sample with quantifiable MK-8931 (above the lower limit of quantification; LLOQ) after a single oral dose of MK-8931 40 mg. Individual AUC0-last values were ln-transformed and evaluated with an ANCOVA model containing a categorical factor for participant group (Moderate HI, Healthy Matched Control) and continuous covariates for age and BMI. This ANCOVA model was used to compute a geometric least-squares mean and 95% confidence interval for AUC0-last in each arm.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after MK-8931 40 mg dose|All participants who received the single dose of MK-8931 40 mg, complied with trial protocol, and had blood samples available for the evaluation of AUC0-last. One participant with moderate HI discontinued study prior to collection of samples at 72, 96, and 120 hours post-dose and was excluded from analysis.|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2547280|NCT02909153|Primary|Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) Last of Serum Total Iron After Intraperitoneal Administration of Triferic|The PK will be done by assessing the AUC from time zero to the time of the last quantified concentration (AUClast) of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours||||hours x micrograms/ deciliters||Geometric Coefficient of Variation|Geometric Mean
2547241|NCT02910739|Primary|Maximum Observed Plasma Concentration of MK-8931 (Cmax)|Blood samples were collected at each pre-specified time point and plasma was isolated for analysis. Plasma MK-8931 concentration was then quantified at each time point to determine Cmax, defined as the maximum plasma concentration of MK-8931 observed following oral dosing. Individual Cmax values were ln-transformed and evaluated with an ANCOVA model containing a categorical factor for participant group (Moderate HI, Healthy Matched Control) and continuous covariates for age and BMI. This ANCOVA model was used to compute a geometric least-squares mean and 95% confidence interval for Cmax in each arm.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours after MK-8931 40 mg dose|All participants who received the single dose of MK-8931 40 mg, complied with trial protocol, and had blood samples available for the evaluation of Cmax.|||nanomolar (nM)||95% Confidence Interval|Geometric Least Squares Mean
2547242|NCT02910739|Primary|Area Under the Concentration Versus Time Curve of MK-8931 From 0 to Infinity (AUC0-∞)|Blood samples were collected at each pre-specified time point and plasma was isolated for analysis. Plasma MK-8931 concentration was then quantified at each time point to determine AUC0-∞, defined as the area under the MK-8931 concentration versus time curve from 0 (predose) extrapolated to infinity after a single oral dose of MK-8931 40 mg. Individual AUC0-∞ values were natural log (ln) transformed and evaluated with an analysis of covariance (ANCOVA) model containing a categorical factor for participant group (Moderate HI, Healthy Matched Control) and continuous covariates for age and BMI. This ANCOVA model was used to compute a geometric least-squares mean and 95% confidence interval for AUC0-∞ in each arm.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours after MK-8931 40 mg dose|All participants who received the single dose of MK-8931 40 mg, complied with trial protocol, and had blood samples available for the evaluation of AUC0-∞. One participant with moderate HI discontinued study prior to collection of samples at 72, 96, and 120 hours post-dose and was excluded from analysis.|||micromolar(µM)*hour(hr)||95% Confidence Interval|Geometric Least Squares Mean
2547243|NCT02910713|Secondary|Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score|The participant graded their eye discomfort prior to CAE entry, during CAE exposure to threshold, then starting 1 minute after treatment application every 5 minutes in each eye separately using the Ora Calibra ODS where: 0=no discomfort to 4=constant discomfort. Data from the analysis eye was used to determine effectiveness. The analysis eye was defined as the eye that reached the threshold triggering the first application or if both eyes reach the threshold at the same time, the eye with the higher discomfort score or if both eyes are the same, the right eye was used. A negative change from Baseline indicates improvement. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect.|Pre-application to Post-application on Day 0|Participants from the Full Analysis Set (FAS) Population, all randomized participants who initiated a study application, who received both intranasal and extranasal applications.|||score on a scale||Standard Error|Least Squares Mean
2547244|NCT02910713|Primary|Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS)|"The participant rated their eye dryness (both eyes simultaneously) at all visits and every 5 minutes during CAE exposure by placing a vertical mark on the 100 mm horizontal line to indicate the level of eye dryness. 0 corresponds to no dryness and 100 corresponds to maximal dryness. A negative change from Baseline indicates improvement. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect."|Pre-application to Post-application on Day 0|Participants from the Full Analysis Set (FAS) Population, all randomized participants who initiated a study application, who received both intranasal and extranasal applications.|||score on a scale||Standard Error|Least Squares Mean
2547245|NCT02910362|Primary|Number of Eyes With Stable IOP|Determine comparative IOP stability between Abbott and Alcon phacoemulsification equipment.|intraoperative|Eyes with stable IOP|||Eyes|Eyes||Number
2547246|NCT02910167|Secondary|Percentage of Patients With Different Variables Related to the Occurrence of Increase of Transaminases in Patients Under Treatment With Buscapina Compositum N|Percentage of patients with different variables related to the occurrence of increase of transaminases in patients under treatment with Buscapina Compositum N in Metropolitan Lima. No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed.|From the initial dose of study drug until end of the follow up period, up to 113 days|Patients who have received at least one dose of Buscapina Compositum N according to label indications, attended to one of the health centers selected for the study, provided data for the baseline and the follow-up visit.|||Percentage of Patients|||Number
2547247|NCT02910167|Secondary|Percentage of Patients Per Adverse Event Preferred Term in Patients Who Developed Any Adverse Event During Treatment|Percentage of patients per adverse event preferred term in patients who developed any adverse event during treatment with Buscapina Compositum N.|From the initial dose of study drug until end of the follow up period, up to 113 days|Patients who have received at least one dose of Buscapina Compositum N according to label indications, attended to one of the health centers selected for the study, provided data for the baseline and the follow-up visit, and who developed any adverse event during treatment.|||Percentage of Patients|||Number
2547248|NCT02910167|Secondary|Percentage of Patients With Different Drug Utilization Patterns of Buscapina Compositum N in Patients in Metropolitan Lima|Percentage of patients with different drug utilization patterns of Buscapina Compositum N in patients in Metropolitan Lima.|From the initial dose of study drug until end of the follow up period, up to 113 days|Patients who have received at least one dose of Buscapina Compositum N according to label indications, attended to one of the health centers selected for the study, and who provided data for the baseline and the follow-up visit.|||Percentage of Patients|||Number
2547281|NCT02909153|Primary|Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Maximum Concentration (Cmax) of Serum Total Iron After Intraperitoneal Administration of Triferic|The PK will be done by assessing the mean absolute Cmax of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours||||microgram per deciliter||Geometric Coefficient of Variation|Geometric Mean
2547282|NCT02909140|Secondary|Percentage of Patients in Each Arm That Required Use of an Iris Expansion Device During the Procedure||intraoperative|"Data was only collected for the Intracameral Mydriasis' arm"|||percent|||Number
2547249|NCT02910167|Secondary|Percentage of Patients With Different Transaminase Levels Found by the Doctor During the Clinical Evaluation of Patients With Symptoms Related to Potential Liver Damage.|Percentage of patients with different transaminase levels found by the doctor during the clinical evaluation of patients with symptoms related to potential liver damage. No patient with symptoms related to potential liver damage was identified, thus analyses of transaminase levels was not performed.|From the initial dose of study drug until end of the follow up period, up to 113 days|Patients who have received at least one dose of Buscapina Compositum N according to label indications, attended to one of the health centers selected for the study, provided data for the baseline and the follow-up visit, and who reported symptoms related to potential liver damage at the follow-up visit.|||Percentage of Patients|||Number
2547250|NCT02910167|Primary|Percentage of Patients With an Incidence of Adverse Event (AE) Associated to Potential Liver Damage During the Clinical Evaluation of Patients|Percentage of patients with an incidence of Adverse Event (AE) associated to potential liver damage during the clinical evaluation of patients.|From the initial dose of study drug until end of the follow up period, up to 113 days|Patients who have received at least one dose of Buscapina Compositum N according to label indications, attended to one of the health centers selected for the study, and who provided data for the baseline and the follow-up visit.|||Percentage of Patients|||Number
2547251|NCT02910102|Primary|Change in Gait Measurements (cm/Sec) Under Dual Task Condition From Baseline to the End of Each Double-blind Treatment Period Based on Computerized Gait Assessment Tools.|Change from baseline in gait speed (cm/sec) measured on an electronic walkway system under dual task trial condition (meaning walking while performing another task) at the end of each two-week treatment period.|Baseline, 2 weeks|ITT Population|||cm/sec||Standard Error|Least Squares Mean
2547252|NCT02910102|Primary|Change From Baseline in Gait Speed (cm/Sec) Measurements From Baseline to the End of Each Double-blind Treatment Period Based on Computerized Gait Assessment Tools.|Change from baseline in gait speed (cm/sec) measured on an electronic walkway system under single task trial condition (meaning walking only) at the end of each two-week treatment period|Baseline, 2 weeks|ITT Population|||cm/sec||Standard Error|Least Squares Mean
2547253|NCT02910089|Secondary|Patients Achieving HbA1c|Percentage (Proportion x 100) of patients in each study arm achieving optimal HbA1c control in the follow-up period|baseline and at the end of 12 months post index date|Full Analysis Set|||Percentage of Participants|||Number
2547254|NCT02910089|Secondary|Percentage (Proportion x 100) of Patients Achieving Optimal Adherence|Percentage (Proportion x 100) of patients in each study arm achieving optimal adherence (PDC ≥0.80) in the follow-up period|during follow-up period of 12 months post index date|Full Analysis Set|||Percentage of Participants|||Number
2547255|NCT02910089|Secondary|Medication Adherence (PDC Measure)|Mean Adherence (PDC) in each study arm in the follow-up period|during follow-up period of 12 months post index date|Full Analysis Set|||Percentage of Days||Standard Deviation|Mean
2547256|NCT02910089|Primary|Glycosylated Hemoglobin (HbA1c):|Pre- to post-intervention change in mean HbA1c levels|baseline and at the end of 12 months post index date|Full Analysis Set|||Percentage of HbA1c||Standard Deviation|Mean
2547257|NCT02910011|Secondary|Number of Participant With a Change in Investigator's Global Assessment (IGA) in Target Area|1 point reduction of IGA score in Target area pre-treatment compared to post treatment (v3)|4 weeks of topical therapy||||Participants|||Count of Participants
2547258|NCT02910011|Secondary|Number of Participants With Reduction in Growth of Skin Flora Including S.Aureus|(positive or negative), difference in number of growth (0 to 3+++)|up to 4 weeks of study drug use|Number of patients with reduction in growth of skin flora including S.Aureus|||Participants|||Count of Participants
2547259|NCT02910011|Primary|Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0|comparing dermatological scores of treated lesions vs non treated lesions and treated peri-lesional areas with non-treated non-lesional areas|up to 4 weeks of study drug use|0 pts with treatment related adverse events|||Participants|||Count of Participants
2547260|NCT02909907|Secondary|Difference of Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Index Change at Week 12 Compared to Baseline Between Wrist Flexors Versus Wrist Flexors Plus Extensors Group.|QUEST( Quality of Life in Essential Tremor Questionnaire ) is a 30-item, ET-specific quality of life scale . Items contribute to five dimensions. Physical/ADL (9 items ), Psychosocial (9 items), Communication (3 items), Hobbies/Leisure (3 items), and Work/Finances (6 items). The score on each scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. A total or summary index corresponds to the mean of the five domain scores. The total summary index corresponds to the mean of the five domain scores. Maximal score 100: worse quality of life. Minimal Score 0: best quality of life. This outcome represents the median of the differences between baseline and week 6 in QUEST summary index. Positive index change values indicate that the score increased and negative values indicate that the score decreased.|Baseline and 12 weeks.||||score on a scale||Inter-Quartile Range|Median
2547261|NCT02909907|Secondary|12 Week Post Injection Patient Global Impression Scale-Improvement Subscale (PGIS)|"Patient Global Impression Scale-Improvement Subscale (PGIS)~Assessment of improvement graded by patient on a -4 to +4 scale~-4 = severe worsening~0 = no change~+4 = complete abolishment of symptoms~Higher scores represent better outcome."|12 weeks||||score on a scale||Inter-Quartile Range|Median
2547262|NCT02909907|Secondary|12 Week Post Injection in Clinician Global Impression Scale-Improvement Subscale (CGIS)|"12 week post injection in Clinician Global Impression Scale-Improvement Subscale (CGIS)~Assessment of improvement graded by the clinician on a -4 to +4 scale~-4 = severe worsening~0 = no change~+4 = complete abolishment of symptoms~Higher scores represent better outcome."|12 weeks||||score on a scale||Inter-Quartile Range|Median
2547263|NCT02909907|Secondary|12 Weeks Post Injection Tremor Rating Scale for Flexors Group and Flexors Plus Extensors Group.|TRS: Tremor Rating Scale : scale composed of 6 items rated from 0-4. 0=none or normal and 4 = very severe or high level of disability. Total score is the sum of all items. Max score 24 ( maximal severity of tremor) Minimal score 0= no tremor/normal.|12 weeks||||score on a scale||Inter-Quartile Range|Median
2547264|NCT02909907|Secondary|Difference in the Post Injection Grip Strength Change Between Flexor Only Group and Flexor and Extensors Group at 6 Weeks.|the median of the differences in grip strength between baseline and week 6, A negative value indicates a decrease in grip strength in Kg at week 6.|6 weeks||||Kilograms||Inter-Quartile Range|Median
2547265|NCT02909907|Secondary|Difference of the Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Index Change at Week 6 Compared to Baseline Between Wrist Flexors Versus Wrist Flexors Plus Extensors Group.|QUEST( Quality of Life in Essential Tremor Questionnaire ) is a 30-item, ET-specific quality of life scale . Items contribute to five dimensions. Physical/ADL (9 items ), Psychosocial (9 items), Communication (3 items), Hobbies/Leisure (3 items), and Work/Finances (6 items). The score on each scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. A total or summary index corresponds to the mean of the five domain scores. The total summary index corresponds to the mean of the five domain scores. Maximal score 100: worse quality of life. Minimal Score 0: best quality of life. This outcome represents the median of the differences between baseline and week 6 in QUEST summary index.Positive index change values indicate that the score increased and negative values indicate that the score decreased.|Baseline and 6 weeks||||score on a scale||Inter-Quartile Range|Median
2547266|NCT02909907|Secondary|Difference in the 6 Week Post Injection Clinician Global Impression of Improvement Scale (CGIS) Between Flexors Along and Flexors Plus Extensors Groups.|"6 weeks post injection Clinician Global Impression if improvement Scale (CGIS)~Assessment of improvement graded by clinician on a -4 to +4 scale~-4 = severe worsening~0 = no change~+4 = complete abolishment of symptoms~Higher scores represent better outcome."|6 weeks||||score on a scale||Inter-Quartile Range|Median
2547267|NCT02909907|Secondary|Difference in Tremor Rating Scale Score (TSR)Change From Baseline to Week 6 Between Flexors Alone and Flexors Plus Extensors Groups.|TRS: Tremor Rating Scale : scale composed of 6 items rated from 0-4. 0=none/normal and 4 = very severe/high level of disability. Total score is the sum of all items. Max score 24 ( maximal severity of tremor) Minimal score 0= no tremor/normal.|Baseline and 6 weeks||||score on a scale||Inter-Quartile Range|Median
2547268|NCT02909907|Primary|Difference in the 6 Week Post Injection Patient Global Impression of Improvement Scale (PGIS) Between Flexors Along and Flexors Plus Extensors Groups.|"6 weeks post injection Clinician Global Impression if improvement Scale (CGIS)~Assessment of improvement graded by the patient on a -4 to +4 scale~-4 = severe worsening~0 = no change~+4 = complete abolishment of symptoms~Higher scores represent better outcome."|6 weeks||||score on a scale||Inter-Quartile Range|Median
2547269|NCT02909764|Secondary|Blood Pressure|Blood pressure (mmHg) was measured by using an automatic blood pressure machine with pediatric cuff. Blood pressure will be measured at baseline (time 0). There were no a priori hypothesis but were collected as baseline characteristic to ensure no differences between the groups.|Baseline||||mmHg||Standard Error|Mean
2547270|NCT02909764|Secondary|Intake of Cereal During Intervention Period|Mothers recorded the amount of cereal their children ingested during 28 days of the 8-week, at-home intervention period.|28 days||||grams||Standard Error|Mean
2547271|NCT02909764|Secondary|Most Preferred Level of Sucrose|Children were presented with pairs of sucrose solutions of varying concentrations (0.09, 0.18, 0.35, 0.70, 1.05 M). The first pair presented were from the middle range of concentrations. Children tasted each sample and then pointed to the sample they liked better. Each subsequent pair of samples presented contained the concentration selected by the child paired with an adjacent stimulus concentration. This pattern continued until the child either chose the same concentration when paired with both a lower and higher concentration in two consecutive pairs or chose either the highest or the lowest concentration twice consecutively. The entire task was repeated after a 3-minute break, with stimulus pairs presented in reverse order. The geometric mean of the two concentrations chosen in the first and second series was calculated to determine the most preferred levels of sucrose.|At baseline and after 8-week intervention||||mol/L||Standard Error|Geometric Mean
2547272|NCT02909764|Secondary|Salt Taste Detection Thresholds|Detection thresholds (the lowest level of salt detect by taste) were measured via a two-alternative forced-choice procedure|Baseline and after 8-week intervention|Some children did not understand or complete the task.|||mol x 10-3/L||Standard Error|Mean
2547273|NCT02909764|Primary|Relative Preference for Regular vs Low Sodium Cereal|The number of children who preferred the taste of the low salt cereal when compared to the regular sodium cereal|At baseline and after 8-week intervention||||Participants|||Count of Participants
2547274|NCT02909764|Primary|Most Preferred Level of Salt Taste|Children were presented with pairs of broths with varying concentrations of added salt (0.16, 0.24, 0.38, 0.61, 1.05 M) (17) . The first pair of broths (0.24 and 0.61 M salt) presented were from the middle range of concentrations. Children were instructed to taste each sample within a pair for 5 seconds, to rinse between tastings, and then to point to the sample they liked better. Each subsequent pair of samples contained the concentration selected by the participant paired with an adjacent stimulus concentration. This pattern continued until the child either chose the same concentration when paired with both a lower and higher concentration in two consecutive pairs or chose either the highest or the lowest concentration twice consecutively. The entire task was repeated a, with stimulus pairs presented in reverse order. The geometric mean of the two concentrations chosen in the first and second series was calculated to determine most preferred levels of salt.|Baseline (time 0) and after 8-week intervention|Some children did not understand the task and responded at random.|||mol/L||Standard Error|Geometric Mean
2547275|NCT02909153|Secondary|Bioavailability of Triferic Iron Administered Via PD Solution: F(Cmax)|The bioavailability (F) of the maximum serum iron concentration (Cmax) of Triferic iron was quantified for the peritoneal dialysis dose of Triferic for all cohorts.|12 hours||||percent of bioavailability||Geometric Coefficient of Variation|Geometric Mean
2547276|NCT02909153|Primary|Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) 0-12 of Serum Total Iron After Intravenous Administration of Triferic|The PK will be done by assessing the AUC from time zero to 12 hours after the infusion (AUC0-12) of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours||||hours* micrograms/ deciliters||Geometric Coefficient of Variation|Geometric Mean
2547277|NCT02909153|Primary|Pharmacokinetics (PK) of Triferic Iron Administered in Patients on Chronic Peritoneal Dialysis: Area Under the Concentration Curve (AUC) Last of Serum Total Iron After Intravenous Administration of Triferic|The PK will be done by assessing the AUC from time zero to the time of the last quantified concentration (AUClast) of Triferic iron administered intravenously in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours||||hours* micrograms/ deciliters||Geometric Coefficient of Variation|Geometric Mean
2547291|NCT02909140|Secondary|Pupil Size Immediately Prior to Intraocular Lens (IOL) Insertion|Pupil size after insertion of IOL lens|Immediately prior to IOL insertion step of cataract surgery|"Data was only collected for the Intracameral Mydriasis' arm. We analyzed data for 1 participant only because of lack of data for the other participant."|||mm|||Number
2547292|NCT02909140|Secondary|Pupil Size (mm) Immediately After Nuclear Disassembly|Pupil size immediately after breaking up of cataractous lens|Immediately after nuclear disassembly step of cataract surgery|"Data was only collected for the Intracameral Mydriasis' arm. We analyzed data for 1 participant only because of lack of data for the other participant."|||mm|||Number
2547293|NCT02909140|Primary|Pupil Size Immediately Prior to Capsulorrhexis|Pupil size immediately prior to the capsulorrhexis step of cataract surgery. This will be recorded by digital photography and measured by a researcher who is masked to the intervention.|Immediately prior to the capsulorrhexis step of cataract surgery|"Data was only collected for the Intracameral Mydriasis' arm. We analyzed data for 1 participant only because of lack of data for the other participant."|||mm|||Number
2547294|NCT02909101|Secondary|Number of Days of Cocaine Use as Measured by Timeline Followback Interview Methodology|The Timeline Followback Method involves asking subjects to retrospectively estimate their cocaine use 30 days prior to the interview date. Responses therefore range from 0 to 30 days.|Baseline; post-training, approximately 8 weeks||||days||Standard Error|Mean
2547295|NCT02909101|Secondary|Sexual Risk Behavior as Measured by the Risk Assessment Battery (RAB)|The RAB is a standardized survey. Scores range from 0 to 18, with higher scores meaning greater sexual risk.|Baseline; post-training, approximately 8 weeks||||score on a scale||Standard Error|Mean
2547296|NCT02909101|Secondary|Percent Medication Adherence Across All Antiretroviral Medications|0% indicates no doses of medications were taken, and 100% means all doses were taken.|Baseline; post-training, approximately 8 weeks||||percentage of doses||Standard Error|Mean
2547297|NCT02909101|Secondary|Acceptability as Measured by Participant Perception of Benefits and Barriers to Completing Sessions|Participants rated how helpful they found the intervention on a 5 point scale (with 1 being very unhelpful and 5 being very helpful). Acceptability was defined a priori of achieving a mean rating of >3.5 on the 5 point scale for helpfulness.|Post-training, approximately 8 weeks||||score on a scale||Standard Deviation|Mean
2547298|NCT02909101|Secondary|Acceptability as Measured by Participant Ratings|Participants rated how satisfied they found the intervention on a 5 point scale (with 1 being very dissatisfied and 5 being very satisfied). Acceptability was defined a priori of achieving a mean rating of >3.5 on the 5 point scale.|Post-training, approximately 8 weeks||||score on a scale||Standard Deviation|Mean
2547299|NCT02909101|Secondary|Delay Discounting, Measured by the Monetary Choice Questionnaire (MCQ)|The Monetary Choice Questionnaire (MCQ) is a standardized delay discounting task. Because scores are on a logarithmic scale, they were rank ordered for analysis. Ranks range from 1 to 13, with higher ranks meaning higher impulsivity.|Baseline; post-training, approximately 8 weeks|One participant from ACT and two participants from CON were excluded because they did not provide valid responses on the MCQ at the post-training follow-up.|||score on a scale||Standard Error|Mean
2547300|NCT02909101|Primary|Working Memory Assessed by Domain Deficit Score|Measured by domain deficit score, which is a continuous measure of overall impairment on the domain. 0 means no impairment and 5 means highest possible impairment.|Baseline; post-training, approximately 8 weeks||||Score on a scale||Standard Error|Mean
2547301|NCT02908880|Secondary|Number of Patients With Minor Complications, Within 30 Days of Procedure|Incidence of IDE Protocol-defined Minor Complications, analyzed on a per-patient analysis|Up to 30 days after procedure|Primary Analysis Cohort|||Participants|||Count of Participants
2547302|NCT02908880|Secondary|Number of Patients With VARC-2 Major Vascular Complications, Adapted From the VARC-2 Criteria, Within 30 Days of Procedure|Incidence of VARC-2 Major Vascular Complications, analyzed on a per-patient basis|Up to 30 days after procedure|Primary Analysis Cohort|||Participants|||Count of Participants
2547303|NCT02908880|Secondary|Technical Success|Percutaneous vascular closure obtained with the MANTA device without the use of unplanned endovascular or surgical intervention|Within 6 hours after deployment of the MANTA device|Primary Analysis Cohort|||Participants|||Count of Participants
2547304|NCT02908880|Primary|Number of Patients With Major Complications, Within 30 Days of Procedure|IDE Protocol-Defined Major Complications analyzed on a per-patient basis|Up to 30 days after procedure|Primary Analysis Cohort|||Participants|||Count of Participants
2547305|NCT02908880|Primary|Time to Hemostasis|The elapsed time between withdrawal of MANTA sheath/device from artery and first observed and confirmed arterial hemostasis (no or minimal subcutaneous oozing and the absence of expanding or developing hematoma).|During access site closure, usually within an hour of starting the procedure.|Primary Analysis Cohort|||seconds||Standard Deviation|Mean
2547306|NCT02908620|Secondary|Percentage of Responders for QST Heat at Each Time Point|Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that.|Time of application up to one hour post-application|A baseline measure was lost/missing for one treatment so the response could not be calculated.|||Participants|||Count of Participants
2547307|NCT02908620|Secondary|Percentage of Responders for PPT at Each Time Point|Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that.|Time of application up to one hour post-application|Some treatment response data was missing or lost or an invalid value was recorded|||Participants|||Count of Participants
2547308|NCT02908620|Secondary|Onset of Anesthesia for QST Heat|Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that.|Time of application up to one hour post-application|Modified Intent-to-Treat (mITT) population: all randomized subjects who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) either completed the two 60 minute test sessions or returned to baseline values in all evaluation tests.|||Minutes||Standard Deviation|Mean
2547319|NCT02908516|Secondary|Hospital Length of Stay||During hospitalization, likely less than 1 week|Data were not collected post surgery due to study termination.||||||
2547320|NCT02908516|Primary|Number of Transfusion Events||Postoperative day 3|Data were not collected post surgery due to study termination.||||||
2547309|NCT02908620|Secondary|Onset of Anesthesia for PPT|Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that.|Time of application up to one hour post-application|Modified Intent-to-Treat (mITT) population: all randomized subjects who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) either completed the two 60 minute test sessions or returned to baseline values in all evaluation tests.|||Minutes||Standard Deviation|Mean
2547310|NCT02908620|Secondary|Duration of Anesthesia as Measured by QST Heat for One Spray CTY-5339-A Compared to Two Sprays CTY-5339-A|Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that.|Time of application up to one hour post-application||||minutes||Standard Deviation|Mean
2547311|NCT02908620|Secondary|Duration of Anesthesia as Measured by PPT for One Spray CTY-5339-A Compared to Two Sprays CTY-5339-A|Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that.|Time of application up to one hour post-application||||minutes||Standard Deviation|Mean
2547312|NCT02908620|Secondary|Duration of Anesthesia as Measured by QST Heat for Two Sprays CTY-5339-A Compared to One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P (Placebo)|"Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that. Duration of effect was defined as the time (in minutes) from onset to treatment failure (i.e., for PPT, an assessment of Same/More pain, and for QST, the average heat temperature was greater than the average heat temperature at Baseline (non-treated cheek), up to the 60-minute time point (at two consecutive time points)."|Time of application up to one hour post-application|Modified Intent-to-Treat (mITT) population: all randomized subjects who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) either completed the two 60 minute test sessions or returned to baseline values in all evaluation tests.|||minutes||Standard Deviation|Mean
2547313|NCT02908620|Secondary|Duration of Anesthesia as Measured by Pin Prick Test (PPT) for Two Sprays CTY-5339-A Compared to One Spray CTY-5339-CB in Combination With One Spray CTY-5339-P (Placebo)|"Assessments will be made over a period of one hour, with assessments at 1 minute intervals for the first 5 minutes and then every 5 minutes after that. Duration of effect was defined as the time (in minutes) from onset to treatment failure (i.e., for PPT, an assessment of Same/More pain, and for QST, the average heat temperature was greater than the average heat temperature at Baseline (non-treated cheek), up to the 60-minute time point (at two consecutive time points)."|Time of application up to one hour post-application|Modified Intent-to-Treat (mITT) population: all randomized subjects who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) either completed the two 60 minute test sessions or returned to baseline values in all evaluation tests.|||Minutes||Standard Deviation|Mean
2547314|NCT02908620|Primary|Duration of Anesthesia as Measured by Heat Sensation Threshold (QST Heat) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB|"Starting at 5 minutes after drug administration, the QST was done at 5 minute intervals up to the one hour time point. If there was no indication of anesthesia by 10 minutes, the subject was considered a treatment failure and the assessment of PPT was discontinued. In addition, once onset of anesthesia had occurred, if there was no longer any anesthesia at two consecutive evaluation time points from 10 minutes onward, the assessment of QST was discontinued.~The heat stimuli were delivered in 3 repetitions, with inter-stimulus intervals of 30s. The basal thermode temperature was set at a comfortable 35ºC. The rate at which the thermode heated up was set at 0.5ºC/s, while the rate at which it cooled down was set at 8ºC/s. The maximum thermode temperature was set at 51ºC. Heat sensation threshold was defined as the temperature at which the subjects first felt tingling, warmth, heat, or pain."|Change in temperature from baseline (time of application) up to one hour post-application|Modified Intent-to-Treat (mITT) population: all randomized subjects who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) either completed the two 60 minute test sessions or returned to baseline values in all evaluation tests.|||minutes||Standard Deviation|Mean
2547315|NCT02908620|Primary|Duration of Anesthesia as Measured by Pin Prick Test (PPT) for One Spray CTY-5339-A Compared to One Spray CTY-5339-CB|"Evaluations were completed at 1-minute intervals for the first 5 minutes to capture onset of anesthesia. Starting at 5 minutes after drug administration, the PPT was done at 5 minute intervals up to the one hour time point. If there was no indication of anesthesia by 10 minutes, the subject was considered a treatment failure and the assessment of PPT was discontinued. In addition, once onset of anesthesia had occurred, if there was no longer any anesthesia at two consecutive evaluation time points from 10 minutes onward, the assessment of PPT was discontinued.~The PPT was assessed using a 90-mm, 26-gauge pencil-point spinal needle. At screening, 3 pin pricks were performed on each cheek. Pin pricks were assessed using a 0 (no pain) to 10 (severe pain) Numerical Rating Scale (NRS). In order to be eligible for the study, for each cheek, subjects must have had a minimum score of 3 for the last 2 pin pricks, and one of those scores had to be 4 or higher."|Change in pain assessment from baseline (time of application) up to one hour post-application|Modified Intent-to-Treat (mITT) population: all randomized subjects who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) either completed the two 60 minute test sessions or returned to baseline values in all evaluation tests.|||minutes||Standard Deviation|Mean
2547316|NCT02908529|Secondary|Genioglossus Muscle Responsiveness to Increased Ventilatory Drive (Esophageal Pressure Swings)|For genioglossus muscle responsiveness, data will be expressed as change in electromyography of genioglossus (GG EMG) for cmH2O change in esophageal pressure.|1 night|4 patients did not accept to perform intramuscular EMG measurement (genioglossus electromyography) 2 patients were not analyzed because they dropped out after the first arm of the study|||%GG/cmH2O||Inter-Quartile Range|Median
2547317|NCT02908529|Primary|Apnea Hypopnea Index (AHI, Events/Hour of Sleep)|Based on previous studies the investigators anticipate that Atomoxetine and Oxybutynin will reduce AHI more effectively in subjects with moderate sleep apnea, mildly obese (BMI<32), Vpassive > 50% of Veupnea (ventilation during eupneic ventilatory drive), low muscle compensation (Vactive - Vpassive <1 L/min)|1 night|2 participants were not analyzed because they dropped out between the 2 intervention arms|||events/hours of sleep||Inter-Quartile Range|Median
2547318|NCT02908516|Secondary|Complications|Data were not collected post surgery due to study termination.|6 weeks|Data were not collected post surgery due to study termination.||||||
2547323|NCT02908347|Primary|Pharmacokinetics (PK) - Area Under the Curve (AUC) - Subgroups|"AUC (lin-log) - Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose~AUC 2h = area under the plasma concentration-time curve from time zero to 2 hours AUC t = area under the plasma concentration-time curve from time zero to the last quantifiable concentration."|Study Day 1|PK analysis set - Per Protocol Set was divided into 4 Subgroups based on AUC levels for AUC 2h and AUC t, respectively. All patients received test product (100 mg MP1032 (= 2 capsules a 50 mg) provided orally twice daily for 42 days)|||h*ng/mL||Full Range|Median
2547324|NCT02908347|Primary|Pharmacokinetics (PK) - Area Under the Curve (AUC)|"AUC (lin-log) - Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose~AUC 2h = area under the plasma concentration-time curve from time zero to 2 hours AUC t = area under the plasma concentration-time curve from time zero to the last quantifiable concentration."|Study Day 1|PK analysis set - Per Protocol Set|||h*ng/mL||Standard Deviation|Mean
2547325|NCT02908347|Secondary|Modified Nail Psoriasis Severity Index (mNAPSI) - Observed Values and Change From Baseline|"mNAPSI score is a total score computed from answers to 7 questions, 3 of which can be answered with a score ranging from 0 to 3, and 4 of which can be answered with a score ranging from 0 to 1. The total score ranges from 0 to 13, the higher the score the worse the outcome.~No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD) for absolute values and changes from baseline (Study Day 1) at end of Treatment (Study Day 43)."|Study Day 1 and 43|Only patients with psoriatic nail disease were evaluated|||score on a scale||Standard Deviation|Mean
2547326|NCT02908347|Secondary|EQ-5D 5L Visual Analogue Scale (VAS)|"EQ-5D (VAS) is a total score which records the patients' self-rated health status with the scale numbered 0 (worst imaginable) to 100 (best imaginable)~No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD) for absolute values and changes from baseline (Study Day 1) at end of Treatment (Study Day 43)."|Study Day 1 and 43||||score on a scale||Standard Deviation|Mean
2547327|NCT02908347|Secondary|Dermatology Life Quality Index (DLQI) - Observed Values and Change From Baseline.|"DLQI is a total score ranging from 0 (life quality is not affected) to 30 (deep impact on life quality) computed from answers to 10 questions, with each answer scored from 0 (not at all) to 3 (very much).~No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD) for absolute values and changes from baseline (Study Day 1) on end of treatment (Day 43)."|Study Day 1 and 43||||score on a scale||Standard Deviation|Mean
2547328|NCT02908347|Secondary|Physician's Global Assessment (PGA) - Observed Values and Change From Baseline|"PGA is the physician's global assessment of the severity of psoriasis using a 7-point scale from 0 (clear) to 6 (severe).~No formal hypothesis testing, variables will be summarized by descriptive statistics (n, mean, SD) for absolute values and changes from baseline (Study Day 1) at Study Day 43 (End of Treatment)."|Study Day 1 and 43||||score on a scale||Standard Deviation|Mean
2547329|NCT02908347|Secondary|Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Responder Frequency|"PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.~PASI 30 and PASI 50 are related to the number of patients (responder frequency (%)) who had at least 30% (PASI 30) or 50% (PASI 50) reduction in PASI score compared to baseline (Study Day 1).~Variables are summarized by descriptive statistics (n, mean, SD, )."|Study Day 1, 29 and 43|Number of patients may vary between days due to drop outs or missing data points|||percentage of participants|||Number
2547330|NCT02908347|Secondary|Psoriasis Area Severity Index (PASI) - PASI 30 and PASI 50 - Number of Patients|"PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.~PASI 30 and PASI 50 are related to the number of patients who had at least 30% (PASI 30) or 50% (PASI 50) reduction in PASI score compared to baseline (Study Day 1).~Variables are summarized by descriptive statistics (n, mean, SD, ). Difference between groups has been analyzed via Fisher exact test."|Study Day 1, 29 and 43|Number of patients may vary between days due to drop outs or missing data points|||participants|||Number
2547331|NCT02908347|Secondary|Psoriasis Area Severity Index (PASI) - PASI Percentage Change - Including Subgroup Analysis AUCt|"The PASI percentage change in % at Day 29 is calculated as PASI of (Day 29 - Baseline)/Baseline*100).~The PASI percentage change in % at Day 43 is calculated as PASI of (Day 43 - Baseline)/Baseline*100).~Baseline = Study Day 1~PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.~No formal hypothesis testing, variables are summarized by descriptive statistics (n, mean, SD)."|Study Day 1, 29 and 43|"Patients of verum group were grouped into the following AUC subgroups according to AUCt values estimated using the linear-logarithmic trapezoidal method on Day 1:~Group 1: 6 patients with the lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs."|||Percentage - Change from Baseline Score||Standard Deviation|Mean
2547332|NCT02908347|Secondary|Psoriasis Area Severity Index (PASI) - PASI Percentage Change - Including Subgroup Analysis AUC2h|"The PASI percentage change in % at Day 29 is calculated as PASI of (Day 29 - Baseline)/Baseline*100).~The PASI percentage change in % at Day 43 is calculated as PASI of (Day 43 - Baseline)/Baseline*100).~Baseline = Study Day 1~PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.~No formal hypothesis testing, variables are summarized by descriptive statistics (n, mean, SD)."|Study Day 1, 29 and 43|"Patients of verum group were grouped into the following AUC subgroups according to AUC2h values estimated using the linear-logarithmic trapezoidal method on Day 1:~Group 1: 6 patients with the lowest AUCs; Group 2: 5 patients with the next highest AUCs; Group 3: 6 patients with the next highest AUCs; Group 4: 5 patients with the highest AUCs."|||Percentage - Change from Baseline Score||Standard Deviation|Mean
2547333|NCT02908347|Secondary|Psoriasis Area Severity Index (PASI) - Change From Baseline|"Change from Baseline (PASI value Day 43 - PASI value at Day 1) / Treatment difference on Day 43~PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.~Variables will be summarized by descriptive statistics (n, mean, SD), difference between groups is analyzed via non-parametric statistical testing."|Study Day 1 and 43||||score on a scale||Standard Deviation|Mean
2547514|NCT02906813|Secondary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose||Baseline up to Day 11|The safety analysis set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
2547334|NCT02908347|Secondary|Psoriasis Area Severity Index (PASI) - Observed PASI Values|"Observed PASI values. PASI is a total score computed over 4 body regions with 4 assessments ranging from 0 (no symptoms) to 4 (very marked). The total score ranges from 0 to 72.~No formal hypothesis testing, variables are summarized by descriptive statistics (n, mean, SD, )."|Study Day 1, 43, 57 and 71|Number of patients may vary between days due to drop outs or missing data points|||score on a scale||Standard Deviation|Mean
2547335|NCT02908347|Primary|Pharmacokinetics (PK) - Time|"Sampling 15 minutes, 30 minutes, 1 hour, and 2 hours postdose~t max = Time corresponding to occurence of Cmax t last = Time of last quantifiable concentration"|Study Day 1|PK analysis set - Per Protocol Set|||hours||Full Range|Median
2547336|NCT02908347|Primary|Pharmacokinetics (PK) - Maximum Observed Concentration (Cmax)|Maximum observed plasma concentration (Cmax)as observed on Day 1 with sampling times of 15 minutes, 30 minutes, 1 hour, and 2 hours postdose|Study Day 1|PK analysis set - Per Protocol Set|||ng/mL||Standard Deviation|Mean
2547337|NCT02908347|Primary|Pharmacokinetics (PK) - Plasma Concentrations|"Study Day 1 - sampling 15 minutes, 30 minutes, 1 hour and 2 hours postdose Study Days 15, 29 and 43 - only one sample was taken any time postdose (time of the last dose was recorded).~No statistical Evaluation has been performed."|Study Days 1, 15, 29 and 43|Participants who gave plasma for PK data and finished the study. (Data from study day 43 were not calculated since less than one-third of the individual data points were quantifiable at the nominal time point.)|||ng/mL||Standard Deviation|Mean
2547338|NCT02908347|Primary|Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With Related TEAEs by SOC|"Number of patients with related TEAEs (Treatment Emergent Adverse Events) occured by SOC (System Organ class) was determined by treatment group.~Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section Reported Adverse Events.~AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE."|Continuously from Treatment Start until the last follow-up visit on Study Day 71||||Participants|||Count of Participants
2547339|NCT02908347|Primary|Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Patients With TEAEs|"Number of patients with TEAEs (Treatment Emergent Adverse Events) was determined by treatment group.~Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section Reported Adverse Events.~AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE."|Continuously from Treatment Start until the last follow-up visit on Study Day 71||||Participants|||Count of Participants
2547340|NCT02908347|Primary|Safety - Treatment Emergent Adverse Events (TEAEs) - Number of Related TEAEs by SOC|"Number of related TEAEs (Treatment Emergent Adverse Events) occured by SOC (System Organ class) was determined by treatment group.~Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section Reported Adverse Events.~AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE."|Continuously from Treatment Start until the last follow-up visit on Study Day 71||||TEAEs|||Number
2547341|NCT02908347|Primary|Safety - Treatment Emergent Adverse Events (TEAEs) - Number of TEAEs|"Number of TEAEs (Treatment Emergent Adverse Events) occured was determined by treatment group.~Furthermore, the absolute and relative frequencies for patients with a given AE, as well as the number of events of the individual AEs that have occurred throughout the study (inclusive screening), were determined within each treatment group and system organ class. Results thereto are provided in the section Reported Adverse Events.~AEs are collected throughout the study. Abnormal values received from Clinical Laboratory Safety Testing (hematology, biochemistry and urinalysis on Study Days 1, 15, 29, 43, 57 and 71), Vital Signs (Systolic blood pressure, diastolic blood pressure, heart rate, tympanic body temperature and respiration rate on Study Days 1, 15, 29, 43, 57 and 71), ECG (Study Days 1, 43 and 71) and Physical Examination (Study Days 1, 43 and 71) were also handled as AE."|Continuously from Treatment Start until the last follow-up visit on Study Day 71||||TEAEs|||Number
2547342|NCT02908269|Secondary|Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 3: ≥ 65 Years)|Anti-influenza antibodies were measured using HAI assay for 3 strains: H1N1, H3N2, Victoria lineage. Seroprotection was defined as an antibody titer ≥ 40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination.|Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)|Analysis was performed on PPAS.|||Participants|||Count of Participants
2547343|NCT02908269|Secondary|Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 2: 18 to < 65 Years)|Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage. Seroprotection was defined as an antibody titer ≥ 40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination.|Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)|Analysis was performed on PPAS.|||Participants|||Count of Participants
2547431|NCT02907463|Secondary|First Attempt Success Rate|The successful delivery and deployment of the valve and delivery system during the first attempt, and subject leaving the operating room with EDWARDS INTUITY Elite valve in place.|At time of surgery|The outcome is reported for subjects where data is available. Analysis is based on the enrolled cohort.|||Participants|||Count of Participants
2547344|NCT02908269|Secondary|Number of Participants With Seroprotection to Influenza Vaccine Antigens (Group 1: 3 to < 9 Years)|Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage. Seroprotection was defined as an antibody titer ≥40 (1/dilution [dil]) at pre-vaccination and at post-final vaccination.|Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)|Analysis was performed on PPAS.|||Participants|||Count of Participants
2547345|NCT02908269|Secondary|Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 3: ≥ 65 Years)|Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 3 strains: H1N1, H3N2, Victoria lineage.|Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)|Analysis was performed on PPAS.|||Titers (1/dilutions)||95% Confidence Interval|Median
2547346|NCT02908269|Secondary|Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 2: 18 to < 65 Years)|Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage.|Day 0 (pre-vaccination) and 21 days post-final vaccination (post-vaccination)|Analysis was performed on PPAS.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
2547347|NCT02908269|Secondary|Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies (Group 1: 3 to < 9 Years)|Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, Victoria lineage, Yamagata lineage.|Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)|Analysis was performed using the Per-protocol Analysis Set (PPAS), which included all participants who received study vaccine and had a valid post-vaccination serology result for at least 1 strain.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
2547348|NCT02908269|Primary|Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 2 (18 to < 65 Years) and Group 3 (≥ 65 Years)|Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant; prevents daily activity), erythema & swelling (Grade 1: ≥ 25 to ≤ 50 mm; Grade 2: ≥ 51 to ≤ 100 mm; Grade 3: >100 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), headache, malaise & myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any solicited injection-site & systemic reactions are reported; number of participants with Grade 3 solicited injection-site & systemic reactions are also reported.|Within 7 days after any vaccination|Analysis was performed on safety analysis set.|||Participants|||Count of Participants
2547349|NCT02908269|Primary|Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, and Swelling) and Systemic Reactions (Fever, Headache, Malaise, Myalgia): Group 1 (3 to < 9 Years of Age)|Solicited injection site reactions: Pain (Grade 1: easily tolerated, Grade 2: sufficiently discomforting to interfere with normal behavior or activities, Grade 3: incapacitating, unable to perform usual activities), erythema & swelling (Grade 1: >0 to <25 mm;Grade 2: ≥ 25 to < 50 mm; Grade 3: ≥ 50 mm). Solicited systemic reactions: Fever (Grade 1: ≥ 38.0 degrees Celsius to ≤ 38.4 degrees Celsius, Grade 2: ≥ 38.5 degrees Celsius to ≤ 38.9 degrees Celsius, Grade 3: ≥ 39.0 degrees Celsius), headache, malaise & myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any solicited injection-site & systemic reactions are reported; number of participants with Grade 3 solicited injection-site & systemic reactions are also reported.|Within 7 days after any vaccination|Analysis was performed using the Safety Analysis Set, which included all participants who received the study vaccine. Number of participants analyzed corresponds to participants with available data for the listed solicited reaction.|||Participants|||Count of Participants
2547350|NCT02908178|Secondary|Treated Recurrence|Primary outcomes for Aim 2: Treated recurrence was defined by the receipt of mastectomy after 9 months of a DCIS diagnosis in the Aim 2 matched cohort.|From 9 months post-diagnosis to death/end of study period (up to 1.5 years)|Mahalanobis matching was used to adjust for baseline characteristics and account for potential treatment selection bias, where those who receive SLNB might be systematically different from those who do not. Matches were assigned by choosing the two best non-SLNB patient matches for each SLNB patient. The final matched cohort was used for analyses.|||Participants|||Count of Participants
2547351|NCT02908178|Secondary|Ipsilateral Invasive Breast Cancer Occurrence|Primary outcomes for Aim 2: Ipsilateral invasive breast cancer occurrence after 9 months of a DCIS diagnosis, per SEER reports.|From 9 months post-diagnosis to death/end of study period (up to 1.5 years)|Mahalanobis matching was used to adjust for baseline characteristics and account for potential treatment selection bias, where those who receive SLNB might be systematically different from those who do not. Matches were assigned by choosing the two best non-SLNB patient matches for each SLNB patient. The final matched cohort was used for analyses.|||Participants|||Count of Participants
2547352|NCT02908178|Secondary|Breast Cancer Specific Mortality|Primary outcomes for Aim 2: Breast cancer specific mortality from 9 months post-diagnosis to death or the end of the study period (December, 2014).|From 9 months post-diagnosis to death/end of study period (up to 1.5 years)|Mahalanobis matching was used to adjust for baseline characteristics and account for potential treatment selection bias, where those who receive SLNB might be systematically different from those who do not. Matches were assigned by choosing the two best non-SLNB patient matches for each SLNB patient. The final matched cohort was used for analyses.|||Participants|||Count of Participants
2547353|NCT02908178|Secondary|Lasting Side Effects (Claim-based Measure), Including Lymphedema, Seroma, Wound Infection, or Pain|Secondary outcomes for Aim 2: unadjusted side effects (any side effects, lymphedema, any infection, seroma, pain) in the matched sample by use of sentinel lymph node biopsy (SLNB). Any side effects refer to the occurrence of one or more of the following complications since diagnosis of DCIS: lymphedema related complications, any infection, seroma, and any pain.|From 9 months post-diagnosis to death/end of study period (up to 1.5 years)|Mahalanobis matching was used to adjust for baseline characteristics and account for potential treatment selection bias, where those who receive SLNB might be systematically different from those who do not. Matches were assigned by choosing the two best non-SLNB patient matches for each patient. The final matched cohort was used for analyses.|||Participants|||Count of Participants
2549000|NCT02862730|Secondary|Mean Sensed Glucose|Assess the mean sensor glucose using Dexcom sensor downloads across all four arms.|entire 84 hour study|All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.|||mg/dL||Standard Deviation|Mean
2547354|NCT02908178|Secondary|Overall Survival|Secondary outcomes for Aim 2.|From 9 months post-diagnosis to death/end of study period (up to 1.5 years)|Mahalanobis matching was used to adjust for baseline characteristics and account for potential treatment selection bias, where those who receive SLNB might be systematically different from those who do not. Matches were assigned by choosing the two best non-SLNB patient matches for each SLNB patient. The final matched cohort was used for analyses.|||Participants|||Count of Participants
2547355|NCT02908178|Secondary|Receipt of Radiation Therapy|Secondary outcomes for Aim 1: Receipt of radiation therapy within 9 months of DCIS diagnosis.|9 months within DCIS diagnosis|Mahalanobis matching was used to adjust for baseline characteristics and account for potential treatment selection bias, where those who receive SLNB might be systematically different from those who do not. Matches were assigned by choosing the two best non-SLNB patient matches for each SLNB patient. The final matched cohort was used for analyses.|||Participants|||Count of Participants
2547356|NCT02908178|Secondary|Receipt of Mastectomy|Secondary outcomes for Aim 1: receipt of mastectomy with and without SLNB after initial BCS through 6 months after DCIS diagnosis.|6 months within DCIS diagnosis|Mahalanobis matching was used to adjust for baseline characteristics and account for potential treatment selection bias, where those who receive SLNB might be systematically different from those who do not. Matches were assigned by choosing the two best non-SLNB patient matches for each SLNB patient. The final matched sample was used for analyses.|||Participants|||Count of Participants
2547357|NCT02908178|Primary|Side Effects (Claim-based Measure), Including Lymphedema, Seroma, Wound Infection, or Pain|Primary outcomes for Aim 1: Acute and subacute side effects include any complication, lymphedema, seroma, wound infection, and pain.|From the first BCS to 9 months post-diagnosis.|Mahalanobis matching was used to adjust for baseline characteristics to account for potential treatment selection bias, where those who received SLNB might be systematically different from those who did not. Matches were assigned by choosing the two best non-SLNB patient matches for each SLNB patient. The final matched cohort was used for analyses.|||Participants|||Count of Participants
2547358|NCT02907892|Primary|Composite Wound Complication|Occurence of at least one of the following: wound seroma, wound hematoma, wound infection, skin separation of at least 1cm, or other incisional separation or abnormality requiring a bedside procedure to fix|Within 8 weeks following cesarean section|Participants with follow-up data (at least one postpartum visit within 8 weeks of delivery)|||Participants|||Count of Participants
2547359|NCT02907814|Secondary|Change in Cell Density Identified by OCT Scans Over Time|Identification of changes in cell density in OCT scans over time|Baseline and up to 8 weeks.|0 of 6 patients had follow up data, unable to identify change over time.||||||
2547360|NCT02907814|Primary|Number of Participants With Identified Inflammatory Cells on OCT Scan|This measure pertains to the identification of cells in OCT scan of the participants. The inflammatory cells to be identified refer to white blood cells. The anterior segment OCT scan was used to attempt to identify these cells in the anterior chamber of the eyes of the participants.|Through study completion, up to 1 year.|Patients with uveitis identified from clinic.|||Participants|||Count of Participants
2547361|NCT02907619|Secondary|Number of Participants With Anti-drug Antibodies (ADA) Development|The criterion for positive result of ADA samples was ADA titer >=1.88. The criterion for negative result of ADA samples was ADA titer <1.88.|Weeks 1, 25, 49, 73 and Early Termination|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number analyzed refers to the number of participants evaluable for specified rows of time points.|||Participants|||Count of Participants
2547362|NCT02907619|Secondary|Serum PF-06252616 (Domagrozumab) Concentration Versus Time Summary||Weeks 1, 25, 49 and 73|The analysis population included all participants who had received at least 1 dose of study medication and had at least 1 PF-06252616 concentration measured in study B5161004. Participants without contributing to the summary statistics are excluded below. Number analyzed refers to number of participants evaluable for specified rows of time points.|||Nanogram Per Milliliter (ng/mL)||Standard Deviation|Mean
2547363|NCT02907619|Secondary|Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline|"Muscle strength was quantified by means of a handheld dynamometer. The following muscle groups were evaluated: knee extension, elbow flexion, elbow extension, hip abduction and shoulder abduction. 95% Confidence Interval was not calculated when less than or equal to 3 participants' data were available.~Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was start of the study treatment in parent study B5161002."|Baseline,Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Kilograms||95% Confidence Interval|Mean
2547364|NCT02907619|Secondary|Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline|"Muscle strength was quantified by means of a handheld dynamometer. The following muscle groups were evaluated: knee extension, elbow flexion, elbow extension, hip abduction and shoulder abduction. 95% Confidence Interval was not calculated when less than or equal to 3 participants' data were available.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004."|Baseline, Weeks 13, 25, 49, 73.|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Kilograms||95% Confidence Interval|Mean
2547394|NCT02907619|Primary|Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline|"The number of participants pre-dose supine blood pressure and pulse rate meeting categorical summarization criteria are recorded in this table.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004.~(DBP=diastolic blood pressure, SBP=systolic blood pressure; The unit for blood pressure is: mmHg, the unit for pulse rate is: beats per minute [BPM])"|2 Years|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Participants|||Count of Participants
2547365|NCT02907619|Secondary|Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline|"PEFR was one of the Pulmonary Function Tests (PFTs). Three technically adequate peak expiratory flow rate (PEFR) maneuvers were performed and reported in Litres/Minute (L/min), and the highest single PEFR was reported in the database. In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessment of PEFR was completed at approximately the same time of day.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004."|Baseline, Weeks 13, 25, 49 and 73.|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||L/min||95% Confidence Interval|Mean
2547366|NCT02907619|Secondary|Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline|"The FEV1 was recorded as an absolute volume in litres and in terms of predicted values according to age, height, race and gender. The best single FEV1 measurement from a set of 3 was recorded in the database.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004."|Baseline, Weeks 13, 25, 49 and 73.|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Litres||95% Confidence Interval|Mean
2547367|NCT02907619|Secondary|Change From Baseline on the 6MWD - Overall Baseline|"The 6MWD evaluated ambulation ability by measuring the distance walked in 6 minutes. In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessment of 6MWD was completed at approximately the same time of day. This is the overall change from baseline which included the change since enrolling in the parent study B5161002.~Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was start of the study treatment in parent study B5161002."|Baseline,Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Meters||95% Confidence Interval|Mean
2547368|NCT02907619|Secondary|Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline|"The 6MWD evaluated ambulation ability by measuring the distance walked in 6 minutes. In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessment of 6MWD was completed at approximately the same time of day.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004."|Baseline, Weeks 13, 25, 49 and 73.|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Meters||95% Confidence Interval|Mean
2547369|NCT02907619|Secondary|Change From Baseline on the PUL Overall Score - Overall Baseline|"The PUL scale was used to assess motor performance of the upper limb for individuals with DMD. The PUL scale includes 22 items; an entry item defining the starting functional level, and 21 items subdivided into 3 levels; shoulder (4 items), middle (9 items) and distal (8 items). Scoring options per item may not be uniform and may vary from 0-1 to 0-6, according to the performance, with higher values corresponding to better performance. A total maximum score of 74 is achieved by adding the individual level scores; shoulder maximum 16, middle level maximum score 34 and distal level maximum score 24.~This is the overall change from baseline which included the change since enrolling in parent study B5161002. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002."|Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Units on a Scale||95% Confidence Interval|Mean
2547370|NCT02907619|Secondary|Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline|"The PUL scale was used to assess motor performance of the upper limb for individuals with DMD. The PUL scale includes 22 items; an entry item defining the starting functional level, and 21 items subdivided into 3 levels; shoulder (4 items), middle (9 items) and distal (8 items). Scoring options per item may not be uniform and may vary from 0-1 to 0-6, according to the performance, with higher values corresponding to better performance. A total maximum score of 74 is achieved by adding the individual level scores; shoulder maximum 16, middle level maximum score 34 and distal level maximum score 24. In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessment of PUL was completed at approximately the same time of day.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004."|Baseline, Weeks 13, 25, 49 and 73.|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Units on a Scale||95% Confidence Interval|Mean
2547395|NCT02907619|Primary|Summary of Testicular Volume|"Testicular volume was used to monitor pubertal development. Participant's Week 97 visit within Study B5161002 (parent study) was collected as screening data in current study.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004."|Screening, Baseline, Week 49.|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Milliliter||Standard Deviation|Mean
2547371|NCT02907619|Secondary|Change From Baseline on the Ankle ROM - Overall Baseline|"ROM of the ankle was evaluated by goniometry and any occurrences of ankle contractures were recorded. In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessment of ankle ROM was completed at approximately the same time of day. This is the overall change from baseline which included the change since enrolling in the parent study B5161002.~Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002."|Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Degrees of Passive Flexion||95% Confidence Interval|Mean
2547372|NCT02907619|Secondary|Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline|"ROM of the ankle was evaluated by goniometry and any occurrences of ankle contractures were recorded. In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessment of ankle ROM was completed at approximately the same time of day.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004."|Baseline, Weeks 13, 25, 49 and 73.|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Degrees of Passive Flexion||95% Confidence Interval|Mean
2547373|NCT02907619|Secondary|Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline|"A time to event analysis was performed for loss of ambulation. Loss of ambulation was defined as the inability to walk unassisted and without braces for at least 10 m, as assessed and reported by the investigator at each study visit, and confirmed by the inability to walk/run 10 m (as 1 component of the NSAA) evaluated at the next visit at which timed function tests were performed. This is the overall change from baseline which included the change since enrolling in the parent study B5161002.~Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002."|Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Seconds||95% Confidence Interval|Mean
2547374|NCT02907619|Secondary|Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline|"A time to event analysis was performed for loss of ambulation. Loss of ambulation was defined as the inability to walk unassisted and without braces for at least 10 m, as assessed and reported by the investigator at each study visit, and confirmed by the inability to walk/run 10 m (as 1 component of the NSAA) evaluated at the next visit at which timed function tests were performed.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004."|Baseline, Weeks 13, 25, 49, 73.|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Seconds||95% Confidence Interval|Mean
2547375|NCT02907619|Secondary|Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline|"Rise from supine was a timed functional test within NSAA. This test of time-to-stand from supine was analyzed separately for summary tabulation along with the total NSAA score. This is the overall change from baseline which included the change since enrolling in the parent study B5161002.~Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002."|Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Seconds||95% Confidence Interval|Mean
2547376|NCT02907619|Secondary|Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline|"Rise from supine was a timed functional test within NSAA. This test of time-to-stand from supine was analyzed separately for summary tabulation along with the total NSAA score.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004."|Baseline, Weeks 13, 25, 49, 73.|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Seconds||95% Confidence Interval|Mean
2547377|NCT02907619|Secondary|Change From Baseline on the NSAA Score - Overall Baseline|"The NSAA was a 17-item test that measured gross motor function. Each individual item was evaluated with either 0-unable to perform independently, 1-able to perform with assistance, 2-able to perform without assistance. A total score was achieved by summing all the individual items. The total score could range from 0 to 34 (fully-independent function). This is the overall change from baseline which included the change since enrolling in the parent study B5161002.~Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002."|Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Units on a Scale||95% Confidence Interval|Mean
2547515|NCT02906813|Secondary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose.||Baseline up to Day 11|The safety analysis set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
2547378|NCT02907619|Secondary|Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline|"The NSAA was a 17-item test that measured gross motor function. Each individual item was evaluated with either 0-unable to perform independently, 1-able to perform with assistance, 2-able to perform without assistance. A total score was achieved by summing all the individual items. The total score could range from 0 to 34 (fully-independent function).~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004."|Baseline, Weeks 13, 25, 49, 73.|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Units on a Scale||95% Confidence Interval|Mean
2547379|NCT02907619|Secondary|Change From Baseline on the FVC - Overall Baseline|"Forced vital capacity (FVC) was measured using the FVC maneuver by spirometry to evaluate respiratory muscle function. The best (largest) FVC measurement from a set of 3 was captured on the database. This is the overall change from baseline which included the change since enrolling in the parent study B5161002.~Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002."|Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Litres||95% Confidence Interval|Mean
2547380|NCT02907619|Secondary|Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline|"FVC was measured using the FVC maneuver by spirometry to evaluate respiratory muscle function. The best (largest) FVC measurement from a set of 3 was captured on the database.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004."|Baseline, Weeks 13, 25, 49 and 73.|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Litres||95% Confidence Interval|Mean
2547381|NCT02907619|Secondary|Change From Baseline on the 4SC - Overall Baseline|"The 4SC quantified the time required for a participant to ascend 4 standard steps. The functional assessment of 4SC was conducted by a physiotherapist (or exercise physiologist). In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessments were completed at approximately the same time of day.~This is the overall change from baseline which included the change since enrolling in the parent study B5161002.~Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002."|Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Seconds||95% Confidence Interval|Mean
2547382|NCT02907619|Secondary|Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline|"The 4SC quantified the time required for a participant to ascend 4 standard steps. The functional assessment of 4SC was conducted by a physiotherapist (or exercise physiologist). In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessments were completed at approximately the same time of day.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004."|Baseline, Weeks 13, 25, 49, 73.|This analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.|||Seconds||95% Confidence Interval|Mean
2547383|NCT02907619|Primary|Number of Participants With Suicidal Ideation or Suicidal Behavior|The Columbia Suicide Severity Rating Scale (C-SSRS) was performed to identify the risk of suicide ideation or behavior. C-SSRS was conducted with the participant's caregiver/legal guardian on the participant's behalf throughout the study, rather than administering this evaluation directly with the study participants. If at any visit the participant endorsed a 4 or 5 on the C-SSRS ideation section or reported any suicidality behavior, then an evaluation of suicide risk (risk assessment) had to be completed and the participant must have been discontinued. The significant result of C-SSRS was determined by the investigator.|2 Years|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.|||Participants|||Count of Participants
2547384|NCT02907619|Primary|Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time|"Bone mineral density (BMD) was monitored by dual energy x-ray absorptiometry (DXA). DXA scans were obtained to evaluate bone mineral density of the spine and whole body without head.~The height adjusted Z-score presented below is the number of standard deviations which compares the BMD of the participant to the average BMD matched for their age, sex and ethnicity. If the Z-score was -2 standard deviations or lower, the result was below the expected range for age. If the Z-score was above -2 standard deviations, the result was within the expected range for age."|Screening (Week 97 visit within parent study B5161002) and Week 49|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Standard Deviations||Standard Deviation|Mean
2547385|NCT02907619|Primary|Bone Age to Chronological Age Ratio|"Bone age assessment was evaluated by the ratio of the bone age to the chronological age using the X rays of the hand and wrist. Ratio of bone age to chronological age was calculated by bone age/chronological age at scan date. Chronological age at scan date was calculated by (scan date - date of birth + 1)/365.25.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004."|Baseline and Week 49.|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Ratio||Standard Deviation|Mean
2547386|NCT02907619|Primary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline|"The LVEF was the ratio of blood ejected during systole to blood in the ventricle at the end of diastole. LVEF was measured by cardiac magnetic resonance imaging (MRI) or echocardiography. The same method of cardiac imaging was used consistently for each participant. Cardiac MRIs were read by a central imaging vendor, while echocardiograms were read locally (at each site). The table presents the results from echocardiograms.~Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002."|Baseline, Weeks 49, 97, 146.|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Ratio of Ejected Blood||Standard Deviation|Mean
2547387|NCT02907619|Primary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - B5161004 Baseline|"The LVEF was the ratio of blood ejected during systole to blood in the ventricle at the end of diastole. LVEF was measured by cardiac magnetic resonance imaging (MRI) or echocardiography. The same method of cardiac imaging was used consistently for each participant. Cardiac MRIs were read by a central imaging vendor, while echocardiograms were read locally (at each site). The table presents the results from echocardiograms.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004."|Baseline, Week 49.|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Ratio of Ejected Blood||Standard Deviation|Mean
2547388|NCT02907619|Primary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - Overall Baseline|"The LVEF was the ratio of blood ejected during systole to blood in the ventricle at the end of diastole. LVEF was measured by cardiac magnetic resonance imaging (MRI) or echocardiography. The same method of cardiac imaging was used consistently for each participant. Cardiac MRIs were read by a central imaging vendor, while echocardiograms were read locally (at each site). The table presents the results from cardiac MRIs.~Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002."|Baseline, Weeks 49, 97, 146.|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Ratio of Ejected Blood||Standard Deviation|Mean
2547389|NCT02907619|Primary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - B5161004 Baseline|The LVEF was the ratio of blood ejected during systole to blood in the ventricle at the end of diastole. LVEF was measured by cardiac magnetic resonance imaging (MRI) or echocardiography. The same method of cardiac imaging was used consistently for each participant. Cardiac MRIs were read by a central imaging vendor, while echocardiograms were read locally (at each site). The table presents the results from cardiac MRIs. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.|Baseline and Week 49.|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Ratio of Ejected Blood||Standard Deviation|Mean
2547390|NCT02907619|Primary|Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria|"Liver Magnetic Resonance Imaging (MRIs) were sent to an independent central radiology imaging facility for calculation of the average R2* value which was used to monitor for iron accumulation in the liver. Mean R2* values had been used in the calculations.~Normal: R2* <= 75 Hz at 1.5 T or <=139 Hz at 3.0 T; Above Normal: R2* > 75 Hz and <= 190 Hz at 1.5 T or R2* > 139 Hz and <= 369 Hz at 3.0 T Mild overload: R2* > 190 Hz at 1.5 T or R2* > 369 Hz at 3.0 T Data from participant's Week 93 visit in Study B5161002 (parent study) were used for screening in the current study."|Screening and Week 49.|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Participants|||Count of Participants
2547391|NCT02907619|Primary|Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - Overall Baseline|"QT=time between the start of the Q wave and the end of the T wave in the heart's electrical cycle; QTcF=corrected QT (Fridericia correction). All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position.~Overall baseline was defined as the average of the last triplicate pre-dose measurements prior to the first day of dosing in study B5161002."|2 Years|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.|||Participants|||Count of Participants
2547392|NCT02907619|Primary|Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline|"QTcF=QT/(60/Hour)**(1/3). Means of replicates were used in the calculations. QT=time between the start of the Q wave and the end of the T wave in the heart's electrical cycle; QTcF=corrected QT (Fridericia correction). All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position.~Baseline was defined as the average of the last triplicate pre-dose measurements prior to Day 1 in B5161004."|2 Years|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004 and who were evaluable for this outcome measure.|||Participants|||Count of Participants
2547393|NCT02907619|Primary|Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline|"The number of participants with data of pre-dose supine blood pressure meeting categorical summarization were recorded in this table.~Overall Baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002.~(DBP=diastolic blood pressure, SBP=systolic blood pressure; The unit for blood pressure is: mmHg)."|2 Years|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.|||Participants|||Count of Participants
2547396|NCT02907619|Primary|Summary of Pubertal Development by Tanner Stage|"Tanner staging was performed before the first dose of this study to monitor for signs of accelerated sexual development. The physical changes in pubertal development (pubic hair, penis and testes) were assessed using the system described by Marshall and Tanner. Stage 1 is preadolescent, Stages 2, 3, and 4 are initiation of puberty and Stage 5 is mature adult. Details about the system can be referred to Tanner JM. Growth at Adolescence. Blackwell Scientific Publications 1962; 2nd edition.~Participant's Week 97 visit within study B5161002 (parent study) was collected as screening data.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004."|Screening, Baseline, Week 49.|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Participants|||Count of Participants
2547397|NCT02907619|Primary|Number of Participants With Significant Results of Physical Examinations Including Nose and Throat Mucosal Examinations|Physical examinations were conducted by a physician, trained physician's assistant, or nurse practitioner as acceptable according to local regulation. A targeted nose and throat mucosal exam was performed to monitor for any signs of mucosal telangiectasias. The clinically significant physical examination results were determined by the investigator.|2 Years|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.|||Participants|||Count of Participants
2547398|NCT02907619|Primary|Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline|"Participants were asked to fast for at least 8 hours prior to collection of blood to evaluate serum iron, serum ferritin and % transferrin saturation. The unit of iron was mcg/dL; the unit of ferritin was ng/mL; the unit of %transferrin saturation was %.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004."|Baseline, Weeks 13, 25, 37, 49, 61, 73 and 85.|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Participants|||Count of Participants
2547399|NCT02907619|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Fecal Blood|"Number of participants with blood detected in fecal samples is presented. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004.~(ULN=Upper Limit of Normal)."|2 Years|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004 and who were evaluable for this outcome measure.|||Participants|||Count of Participants
2547400|NCT02907619|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis|"Urinalysis Microscopy included: urine red blood cell (RBC), urine white blood cell (WBC), urine uric acid crystals, urine calcium oxalate crystals, urine amorphous crystals, urine bacteria, urine microscopic exam.~Urinalysis Dipstick included: urine pH, urine glucose, urine ketones, urine protein, urine blood/hemoglobin, urine nitrite, urine leukocyte esterase.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004."|2 Years|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Participants|||Count of Participants
2547401|NCT02907619|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry|"Clinical chemistry evaluation included glucose, creatine kinase (CK), troponin I, amylase, iron binding capacity, unsaturated iron binding capacity, transferrin saturation, iron and ferritin. Number of participants with iron abnormalities was reported in different age groups.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004.~(LLN=Lower Limit of Normal, ULN=Upper Limit of Normal)."|2 Years|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Participants|||Count of Participants
2547402|NCT02907619|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones|"Hormone evaluations included free thyroxine (T4), thyroid stimulating hormone (TSH), lutenizing hormone (LH), follicle stimulating hormone (FSH), and androstenedione. Numbers of participants with abnormalities of LH, FSH and androstenedione were reported in different age groups.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004.~(LLN=Lower Limit of Normal, ULN=Upper Limit of Normal)."|2 Years|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Participants|||Count of Participants
2547403|NCT02907619|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes|"Electrolytes evaluation included: sodium, potassium, chloride, calcium, phosphate and bicarbonate.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004.~(LLN=Lower Limit of Normal, ULN=Upper Limit of Normal)."|2 Years|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.|||Participants|||Count of Participants
2547404|NCT02907619|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Renal Function|"Renal function evaluation included: blood urea nitrogen (BUN), creatinine and uric acid.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (ULN=Upper Limit of Normal)."|2 Years|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.|||Participants|||Count of Participants
2547516|NCT02906813|Secondary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose||Baseline up to Day 11|The safety analysis set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
2547405|NCT02907619|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function|"Liver function evaluation included: total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase, total protein, albumin and glutamate dehydrogenase.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004.~(LLN=Lower Limit of Normal; ULN=Upper Limit of Normal)."|2 Years|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.|||Participants|||Count of Participants
2547406|NCT02907619|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Coagulation|"Coagulation evaluation included activated partial thromboplastin time (aPTT) and prothrombin time (PT).~(ULN=Upper Limit of Normal). Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004."|2 Years|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.|||Participants|||Count of Participants
2547407|NCT02907619|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology|"Hematology evaluation included: hemoglobin, hematocrit, red blood cell (RBC) count, platelets, RBC morphology, white blood cell (WBC) count, absolute lymphocytes, absolute atypical lymphocytes, absolute total neutrophils, absolute total neutrophils count, absolute band cells, absolute basophils, absolute eosinophils and absolute monocytes.~Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004.~(ULN=Upper Limit of Normal; LLN=Lower Limit of Normal)."|2 Years|Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Participants|||Count of Participants
2547408|NCT02907619|Primary|Number of Participants Who Discontinued From the Study Due to TEAEs|An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment or usage. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. The number of participants who discontinued from the study due to both all-causality and treatment-related TEAEs are presented below.|2 Years|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.|||Participants|||Count of Participants
2547409|NCT02907619|Primary|Number of Participants With Severe Treatment-Emergent Adverse Events (TEAEs)|An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment or usage. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Severe TEAEs were TEAEs that interfered significantly with participants' usual function. Treatment-related TEAEs were determined by the investigator. The number of participants with severe all-causality and treatment-related TEAEs are presented below.|2 Years|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.|||Participants|||Count of Participants
2547410|NCT02907619|Primary|Number of Participants With Dose Reduced or Temporary Discontinuation Due to AEs|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment or usage. Treatment-related AEs were determined by the investigator. The number of participants with dose reduced or temporary discontinuation due to both all-causality and treatment-related AEs are presented below.|2 Years|The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.|||Participants|||Count of Participants
2547411|NCT02907489|Secondary|Intracanal Bacterial Count|Colony forming units per milliliter of blood agar medium before root canal preparation (S1), after root canal preparation (S2) and after intracanal medication application for 72 hours (S3)|before and after mechanical preparation (at day 0) and after 72 hour from placement of the intracanal medication.||||CFU/ml||Standard Deviation|Mean
2547412|NCT02907489|Primary|Post Operative Pain|"Visual Analogue Scale (VAS) of post operative pain (The VAS consisted of a 100 mm horizontal ruler without numbers except a 0 at its first part and a 10 in the last part. With 0 indicating the best outcome while 10 the worst outcome. The subjects were asked to mark the point that was equivalent to their pain intensity. The pain levels were classified as no pain [0], mild pain [1-3], moderate pain [4-7] or severe pain [8-10] )"|after 24, 48, and 72 hour from the end of the first visit.||||score on a scale||Standard Deviation|Mean
2547413|NCT02907463|Other Pre-specified|Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)|Number of late adverse events divided by the total number of late patient years x 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).|Events occuring >= 31 days and up through 6 months|The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.|||percentage of events/late patient years|||Number
2547414|NCT02907463|Other Pre-specified|Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)|Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100|Events occurring within 30 days of procedure|The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.|||Percentage of events/subjects|||Number
2547415|NCT02907463|Other Pre-specified|Subject's Average Fitness for Hospital Discharge|Considered as the day at which the patient was fit for hospital discharge.|Day of surgical procedure through discharge from the hospital; an average of 7 days|The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.|||days||Standard Deviation|Mean
2547416|NCT02907463|Other Pre-specified|Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time|The EuroQol-5 Dimension (EQ-5D) is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.|Baseline and 6 months|The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.|||units on a scale||Standard Deviation|Mean
2547417|NCT02907463|Other Pre-specified|Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity.~Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.~Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.~Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.~Symptoms of heart failure or the anginal syndrome may be present even at rest."|6 months compared to baseline|The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.|||Participants|||Count of Participants
2547418|NCT02907463|Other Pre-specified|Subject's Average SF-36 Mental Health Summary|The Medical Outcomes Study Short-Form 36 - Mental Health Summary The SF-36 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.|Baseline and 6 months|The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.|||units on a scale||Standard Deviation|Mean
2547419|NCT02907463|Other Pre-specified|Subject's Average SF-36 Physical Health Summary|The Medical Outcomes Study Short-Form 36 - Physical Health Summary The SF-36 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.|Baseline and 6 months|The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.|||units on a scale||Standard Deviation|Mean
2547420|NCT02907463|Secondary|Subject's Amount of Aortic Valvular Regurgitation Over Time.|Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.|Discharge and 6 Months|The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.|||Participants|||Count of Participants
2547421|NCT02907463|Secondary|Subject's Amount of Paravalvular Leak Over Time.|Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.|Discharge and 6 months|The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.|||Participants|||Count of Participants
2547422|NCT02907463|Secondary|Subject's Average Cardiac Index|A measure of cardiac output per square meter of body surface area|Discharge and 6 months|The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.|||L/min/meters squared||Standard Deviation|Mean
2547423|NCT02907463|Secondary|Subject's Average Cardiac Output Over Time|The amount of blood the heart pumps through the circulatory system in a minute.|Baseline, Discharge and 6 months|The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.|||liters per minute||Standard Deviation|Mean
2547424|NCT02907463|Secondary|Subject's Average Performance Index Measurements Over Time.|Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's pre-implant orifice area. Effective orifice area is evaluated by echocardiography over time.|Baseline, Discharge and 6 months|The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.|||cm2/cm2||Standard Deviation|Mean
2547425|NCT02907463|Secondary|Subject's Average Effective Orifice Area Index (EOAI) Measurement Over Time.|Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.|Discharge and 6 months|The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.|||centimeters squared/meters squared||Standard Deviation|Mean
2547426|NCT02907463|Secondary|Subject's Average Effective Orifice Area (EOA) Measurements Over Time|Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.|Baseline, Discharge and 6 months|The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.|||centimeters squared||Standard Deviation|Mean
2547427|NCT02907463|Secondary|Subject's Average Peak Gradients Measurements Over Time.|Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.|Baseline, Discharge and 6 months|The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.|||mmHg||Standard Deviation|Mean
2547428|NCT02907463|Secondary|Subject's Average Mean Gradient Measurements Over Time.|Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.|Baseline, Discharge and 6 months|The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.|||mmHg||Standard Deviation|Mean
2547429|NCT02907463|Secondary|Subject's Average Health Care Utilization|The average amount of time the subjects spent in the intensive care unit and the average total length of hospital stay after their heart valve replacement procedure.|Day of surgical procedure through discharge from the hospital, an average of 3 days and 10 days respectively.|The outcome is reported for subjects where data is available. Analysis is based on the enrolled cohort.|||days||Standard Deviation|Mean
2547430|NCT02907463|Secondary|Procedural Success|Procedural success is defined as device technical success followed by the absence of adverse events requiring device reoperation, requiring implantation of permanent pacemaker (with baseline sinus rhythm and no other conduction issues), or subject death, within discharge or 10 days post index procedure whichever comes first.|Day of procedure and events occurring within 10 days of procedure|The outcome is reported for subjects where data is available. Analysis is based on the enrolled cohort.|||Participants|||Count of Participants
2547432|NCT02907463|Secondary|Device Technical Success Rate|The successful delivery and deployment of the EDWARDS INTUITY Elite valve and delivery system, and the subject leaving the operating room with valve in place.|At time of surgery|The outcome is reported for subjects where data is available. Analysis is based on the enrolled cohort.|||Participants|||Count of Participants
2547433|NCT02907463|Secondary|Subject's Average Time Spent on Cardiopulmonary Bypass.|Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.|At time of surgery; an average of 1.5 hours|The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.|||minutes||Standard Deviation|Mean
2547434|NCT02907463|Primary|Subject's Average Time Spent on Cardiopulmonary Cross Clamp|Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.|At time of surgery; an average of 1 hour|The outcome is reported for subjects where data is available. Analysis is based on the per protocol cohort.|||minutes||Standard Deviation|Mean
2547435|NCT02907268|Primary|Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 16 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs|Blinded assessments of overall change in facial wrinkles from baseline to week 16 based on pre and post treatment photographs. Measured on a 5 point scale which is a static assessment of wrinkle severity. 0=wrinkles absent (minimum), 1=shallow but visible wrinkles, 2=fine lines slight indentation, 3=clear indentation 0-1mm deep, 4=moderate indentation 1-2mm deep, 5=deep indentation >2mm deep (maximum). A higher value = a worse outcome (more severe wrinkles). Includes 9 subscales measured on the same scale described above. Subscales measure wrinkle severity in the left and right forehead region, left and right cheek region, left and right crow's feet region, left and right upper lip region, and glabellar region. All scores were computed by averaging subscale ratings.|Baseline and 16 weeks||||units on a scale||Standard Deviation|Mean
2547436|NCT02907268|Primary|Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 4 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs|Blinded assessments of overall change in facial wrinkles from baseline to week 4 based on pre and post treatment photographs. Measured on a 5 point scale which is a static assessment of wrinkle severity. 0=wrinkles absent (minimum), 1=shallow but visible wrinkles, 2=fine lines slight indentation, 3=clear indentation 0-1mm deep, 4=moderate indentation 1-2mm deep, 5=deep indentation >2mm deep (maximum). A higher value = a worse outcome (more severe wrinkles). Includes 9 subscales measured on the same scale described above. Subscales measure wrinkle severity in the left and right forehead region, left and right cheek region, left and right crow's feet region, left and right upper lip region, and glabellar region. All scores were computed by averaging subscale ratings.|Baseline and 4 weeks||||units on a scale||Standard Deviation|Mean
2547437|NCT02907268|Primary|Blinded Assessment: Overall Change in Facial Wrinkles From Baseline to Week 2 as Assessed by a Numeric Rating Scale Based on Pre- and Post-treatment Photographs|Blinded assessments of overall change in facial wrinkles from baseline to week 2 based on pre and post treatment photographs. Measured on a 5 point scale which is a static assessment of wrinkle severity. 0=wrinkles absent (minimum), 1=shallow but visible wrinkles, 2=fine lines slight indentation, 3=clear indentation 0-1mm deep, 4=moderate indentation 1-2mm deep, 5=deep indentation >2mm deep (maximum). A higher value = a worse outcome (more severe wrinkles). Includes 9 subscales measured on the same scale described above. Subscales measure wrinkle severity in the left and right forehead region, left and right cheek region, left and right crow's feet region, left and right upper lip region, and glabellar region. All scores were computed by averaging subscale ratings.|Baseline and 2 weeks||||units on a scale||Standard Deviation|Mean
2547438|NCT02907216|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|Assessed SAEs included any untoward medical occurrence that resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the entire study period (from Day 0 to Month 5)|Analysis was performed on the TVC which included all subjects with at least one dose of the study vaccines administration documented.|||Participants|||Count of Participants
2547439|NCT02907216|Secondary|Number of Subjects With Any Unsolicited AE After First Dose of DTP-IPV Vaccine|Unsolicited AEs were defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) follow-up period after first dose of DTP-IPV vaccine|Analysis was performed on the TVC which included all subjects with at least one dose of the study vaccines administration documented.|||Participants|||Count of Participants
2547440|NCT02907216|Secondary|Number of Subjects With Any Unsolicited AEs After Each Dose of Liquid HRV Vaccine|Unsolicited AEs were defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) follow-up period after each dose of liquid HRV vaccine|Analysis was performed on the TVC which included all subjects with at least one dose of the study vaccines administration documented.|||Participants|||Count of Participants
2547441|NCT02907216|Secondary|Number of Subjects With Any Solicited General AEs After First Dose of DTP-IPV Vaccine|Assessed solicited general AEs were drowsiness, fever (defined as axillary temperature ≥ 37.5 °C), irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 8-day (Days 0-7) follow-up period after first dose of DTP-IPV vaccine|Analysis was performed on the TVC which included all subjects with at least one dose of the study vaccines administration documented.|||Participants|||Count of Participants
2547442|NCT02907216|Secondary|Number of Subjects With Any Solicited Local AEs After First Dose of DTP-IPV Vaccine|Assessed solicited local AEs were pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 8-day (Days 0-7) follow-up period after first dose of DTP-IPV vaccine|Analysis was performed on the TVC which included all subjects with at least one dose of the study vaccines administration documented.|||Participants|||Count of Participants
2547443|NCT02907216|Secondary|Number of Subjects With Any Solicited General Adverse Events (AEs) After Each Dose of Liquid HRV Vaccine|Assessed solicited general AEs were fever (defined as axillary temperature ≥ 37.5 degrees Celsius [°C]), irritability/fussiness, diarrhoea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥ 1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 8-day (Days 0-7) follow-up period after each dose of liquid HRV vaccine|Analysis was performed on the Total Vaccinated cohort (TVC) which included all subjects with at least one dose of the study vaccines administration documented.|||Participants|||Count of Participants
2547444|NCT02907216|Secondary|Anti-PT and Anti-FHA Antibody Concentrations to Evaluate Immunogenicity|Concentrations of anti-PT and anti-FHA antibodies were assessed by ELISA, presented as GMCs and expressed in IU/mL. The assay cut-offs for anti-PT and anti-FHA antibody concentrations were 2.693 IU/mL and 2.046 IU/mL respectively.|One month post third dose of DTP-IPV vaccine (At Month 5)|Analysis was performed on ATP cohort which included all subjects who complied with vaccination schedules of DPT-IPV and HRV vaccines, complied with the blood sampling schedule and for whom immunogenicity data was available for at least for one antigen of the DPT-IPV vaccine at Visit 7 (Month 5) sampling time point.|||IU/mL||95% Confidence Interval|Geometric Mean
2547445|NCT02907216|Secondary|Anti-polio 1, 2 and 3 Antibodies Titers to Evaluate Immunogenicity|Titers of anti-polio 1, 2 and 3 were assessed by Neutralisation Assay (NEU) and presented as Geometric Mean Titers (GMTs). The assay cut-off was 8 ED50.|One month post third dose of DTP-IPV vaccine (At Month 5)|Analysis was performed on ATP cohort which included all subjects who complied with vaccination schedules of DPT-IPV and HRV vaccines, complied with the blood sampling schedule and for whom immunogenicity data was available for at least for one antigen of the DPT-IPV vaccine at Visit 7 (Month 5) sampling time point.|||Titer||95% Confidence Interval|Geometric Mean
2547446|NCT02907216|Secondary|Anti-D and Anti-T Antibody Concentrations to Evaluate Immunogenicity|Concentrations of anti-D and anti-T antibodies were assessed by ELISA, presented as GMCs and expressed in IU/mL. The assay cut-off for anti-D and anti-T antibody concentrations was 0.1 IU/mL.|One month post third dose of DTP-IPV vaccine (At Month 5)|Analysis was performed on ATP cohort which included all subjects who complied with vaccination schedules of DPT-IPV and HRV vaccines, complied with the blood sampling schedule and for whom immunogenicity data was available for at least for one antigen of the DPT-IPV vaccine at Visit 7 (Month 5) sampling time point.|||IU/mL||95% Confidence Interval|Geometric Mean
2547447|NCT02907216|Secondary|Serum Anti-RV IgA Antibody Concentration to Evaluate Immunogenicity in a Sub-cohort of Subjects|Concentration of serum anti-RV IgA antibody was assessed by Enzyme Linked Immunosorbent Assay (ELISA) and expressed as geometric mean concentration (GMC) in U/mL. The assay cut-off was 20 U/mL. Immunogenicity of the liquid HRV vaccine in terms of serum anti-RV IgA antibody GMC was assessed in a sub-cohort of subjects (HRV immunogenicity sub-cohort) which included the first 73 subjects enrolled into each of the 2 study groups.|One month post second dose of liquid HRV vaccine (At Month 2 for the Co-administration Group and at Month 2.5 for the Staggered Group)|Analysis was performed on HRV immunogenicity sub-cohort of ATP cohort which included all subjects who complied with vaccination schedules of DPT-IPV and HRV vaccines, complied with the blood sampling schedule and for whom immunogenicity data was available for at least for one antigen of the DPT-IPV vaccine at Visit 7 (Month 5) sampling time point.|||U/mL||95% Confidence Interval|Geometric Mean
2547448|NCT02907216|Secondary|Percentage of Seropositive Subjects for Serum Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibodies in a Sub-cohort of Subjects|A seropositive subject for serum anti-RV IgA antibodies was defined as a subject with anti-RV IgA antibody concentration ≥ the seropositivity cut-off value of 20 units per milliliter (U/mL). Immunogenicity of the liquid HRV vaccine in terms of serum anti-RV IgA antibody seropositivity was assessed in a sub-cohort of subjects (HRV immunogenicity sub-cohort) which included the first 73 subjects enrolled into each of the 2 study groups.|One month post second dose of liquid HRV vaccine (At Month 2 for the Co-administration Group and at Month 2.5 for the Staggered Group)|Analysis was performed on HRV immunogenicity sub-cohort of ATP cohort which included all subjects who complied with vaccination schedules of DPT-IPV and HRV vaccines, complied with the blood sampling schedule and for whom immunogenicity data was available for at least for one antigen of the DPT-IPV vaccine at Visit 7 (Month 5) sampling time point.|||Percentage of subjects||95% Confidence Interval|Number
2547449|NCT02907216|Primary|Percentage of Subjects With Anti-poliovirus Serotypes 1, 2 and 3 (Anti-polio 1, 2 and 3) Antibody Titers ≥ the Cut-off Value|Percentage of subjects with anti-polio 1, 2 and 3 antibody titers ≥ 8 estimated doses 50% (ED50).|One month post third dose of DTP-IPV vaccine (At Month 5)|Analysis was performed on ATP cohort which included all subjects who complied with vaccination schedules of DPT-IPV and HRV vaccines, complied with the blood sampling schedule and for whom immunogenicity data was available for at least for one antigen of the DPT-IPV vaccine at Visit 7 (Month 5) sampling time point.|||Percentage of subjects||95% Confidence Interval|Number
2547450|NCT02907216|Primary|Percentage of Subjects With Anti-pertussis Toxoid (Anti-PT) and Anti-filamentous Haemagglutinin (Anti-FHA) Antibody Concentrations ≥ the Cut-off Value|Percentage of subjects with anti-PT and anti-FHA antibody concentrations ≥ 10 IU/mL.|One month post third dose of DTP-IPV vaccine (At Month 5)|Analysis was performed on ATP cohort which included all subjects who complied with vaccination schedules of DPT-IPV and HRV vaccines, complied with the blood sampling schedule and for whom immunogenicity data was available for at least for one antigen of the DPT-IPV vaccine at Visit 7 (Month 5) sampling time point.|||Percentage of subjects||95% Confidence Interval|Number
2547451|NCT02907216|Primary|Percentage of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to (≥) the Cut-off Value|Percentage of subjects with anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|One month post third dose of DTP-IPV vaccine (At Month 5)|Analysis was performed on According-to-Protocol (ATP) cohort which included all subjects who complied with vaccination schedules of DPT-IPV and HRV vaccines, complied with the blood sampling schedule and for whom immunogenicity data was available for at least for one antigen of the DPT-IPV vaccine at Visit 7 (Month 5) sampling time point.|||Percentage of subjects||95% Confidence Interval|Number
2551609|NCT02813577|Secondary|Number of Participants With Clinically Driven Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Month Post Index Procedure||1, 6, 12 and 24 months post index procedure|Study terminated.||||||
2547452|NCT02907073|Secondary|Amount of Imaging Agent in Tumor (Uptake) in Myeloma and Endometrial Cancer Patients|Areas of positive uptake within tumor, relative to background, measured by Standardized Update Value (SUV). PET SUV is tissue concentration/injected dose/body weight in grams.|Baseline, Day 9|Healthy volunteers do not have tumors. The study in myeloma and endometrial cancer was terminated due to pursuing IND.||||||
2547453|NCT02907073|Primary|Evaluation of Tissue Distribution of F-18 BF4 in Healthy Volunteers|F-18 BF4 concentrations in major tissues (e.g., heart, blood pool, lung, liver, thyroid, stomach, kidney, brain, muscle) will be evaluated from the PET images from 0-240 minutes post-administration. Results will be used to compute radiation dosimetry estimates.|0-240 minutes|Outcome measures were performed in study arm of eight healthy volunteers. F or the myeloma and endometrial cancer arms of the study, the study was terminated due to pursuing Investigational New Drug application (IND).|||standardized uptake value (SUV)||Standard Deviation|Mean
2547454|NCT02906930|Secondary|PGI-C Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire)|Patient global impression of change (PGI-C) is a 2-item questionnaire used to assess the participant's impression of change from baseline in physical functioning and mental health status. The PGI-C contains two items evaluated on a 7-point graded response scale. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 26|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2547455|NCT02906930|Secondary|PGI-S Item: Scores of the Two Individual Items (Used for Validation of the IWQOL Questionnaire)|Patient global impression of status (PGI-S) is a 2-item questionnaire used to assess the participant's impression of physical functioning and mental health status during the clinical trial. The PGI-S contains two items evaluated on a 5-point graded response scale. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 26|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2547456|NCT02906930|Secondary|IWQOL-Lite Clinical Trial Version: Total Score of the 22 Items (Used for Validation of the Questionnaire)|The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. IWQOL-Lite-CT is a 22-item questionnaire-based instrument used to assess the impact of body weight changes on participant's overall health-related quality of life (HRQoL). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2547457|NCT02906930|Secondary|Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)|SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the sub-domain scores and component summary (PCS and MCS) scores were evaluated at week 26. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2547458|NCT02906930|Secondary|Semaglutide Plasma Concentrations for Population PK Analysis|This outcome measure is only applicable for the oral semaglutide 3 mg, 7 mg and 14 mg treatment arms. Semaglutide plasma concentrations were measured at weeks 4, 8, 14 and 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Weeks 0 - 26|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Nanomoles per litre (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2547459|NCT02906930|Secondary|SNAC Plasma Concentrations|This outcome measure is only applicable for the oral semaglutide 3 mg, 7 mg and 14 mg treatment arms. Sodium N-[8-(2-hydroxybenzoyl) amino]caprylate (SNAC) plasma concentrations were measured after 25 and 40 minutes post-dose at weeks 4, 14 and 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Weeks 0-26|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2547460|NCT02906930|Secondary|Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product|Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 31 (26-week treatment period + 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Weeks 0-31|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Participants|||Number
2547461|NCT02906930|Secondary|Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes During Exposure to Trial Product|Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during week 0 to week 31 (26-weeks treatment period + 5-weeks follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Weeks 0-31|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Episodes|||Number
2547462|NCT02906930|Secondary|Anti-semaglutide Binding Antibody Levels|This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (week 0 to week 31). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Weeks 0-31|Overall number of participants analysed = participants who were found positive for anti-semaglutide antibodies.|||%B/T||Standard Deviation|Mean
2547463|NCT02906930|Secondary|Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)|This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Weeks 0-31|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2547464|NCT02906930|Secondary|Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)|This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Weeks 0-31|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2547465|NCT02906930|Secondary|Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)|This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Weeks 0-31|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2547466|NCT02906930|Secondary|Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)|This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (week 0 to week 31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Weeks 0-31|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2547467|NCT02906930|Secondary|Change in Eye Examination Category|Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2), and week 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2547468|NCT02906930|Secondary|Change in Physical Examination|Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Nervous system (central and peripheral); 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head (ears, eyes, nose), throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.|Week 0, week 26|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2547490|NCT02906930|Secondary|Change in Body Weight (%)|Change from baseline (week 0) to week 26 in body weight. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Percentage change||Standard Deviation|Mean
2551610|NCT02813577|Secondary|Number of Deaths (All Causes) at 30 Days Post Index Procedure||30 days post index procedure||||Participants|||Number
2547469|NCT02906930|Secondary|Change in Electrocardiogram (ECG) Evaluation|Change from baseline (week 0) in ECG was evaluated at week 26. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2547470|NCT02906930|Secondary|Change in Diastolic Blood Pressure (DBP)|Change from baseline (week 0) in DBP was evaluated at week 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||mmHg||Standard Deviation|Mean
2547471|NCT02906930|Secondary|Change in Systolic Blood Pressure (SBP)|Change from baseline (week 0) in SBP was evaluated at week 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||mmHg||Standard Deviation|Mean
2547472|NCT02906930|Secondary|Change in Pulse Rate|Change from baseline (week 0) in pulse rate was evaluated at week 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||beats/min||Standard Deviation|Mean
2547473|NCT02906930|Secondary|Change in Lipase - Ratio to Baseline|Change from baseline (week 0) to week 26 in lipase (U/L) is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2547474|NCT02906930|Secondary|Change in Amylase - Ratio to Baseline|Change from baseline (week 0) to week 26 in amylase (units/litre (U/L)) is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2547475|NCT02906930|Secondary|Number of Treatment-emergent Adverse Events (TEAEs)|Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 31 (26-week treatment period + 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Approximately upto week 31|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.|||Events|||Number
2547476|NCT02906930|Secondary|Time to Rescue Medication|Presented results are the number of participants who had taken rescue medication anytime during the period from week 0 to week 26. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication or premature trial product discontinuation.|Weeks 0-26|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2547477|NCT02906930|Secondary|Time to Additional Anti-diabetic Medication|Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the period from week 0 to week 26. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 26), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Weeks 0-26|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2547478|NCT02906930|Secondary|Participants Who Achieve HbA1c Reduction ≥ 1.0% (10.9 mmol/Mol) and Weight Loss ≥ 3% (Yes/no)|Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at week 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 26|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2547491|NCT02906930|Secondary|Change in CRP - Ratio to Baseline|Change from baseline (week 0) to week 26 in C-reactive protein (CRP) (mg/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio of CRP||Geometric Coefficient of Variation|Geometric Mean
2547479|NCT02906930|Secondary|Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG-confirmed Symptomatic Hypoglycaemia) and Without Body Weight Gain (Yes/no)|Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at week 26 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product|Week 26|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2547480|NCT02906930|Secondary|Participants Who Achieve Body Weight Loss ≥ 10 % (Yes/no)|Participants who achieved body weight loss more than or equal to 10% of their baseline body weight (yes/no) at week 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 26|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2547481|NCT02906930|Secondary|Participants Who Achieve Body Weight Loss ≥ 5 % (Yes/no)|Participants who achieved body weight loss more than or equal to 5% of their baseline body weight (yes/no) at week 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 26|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2547482|NCT02906930|Secondary|Participants Who Achieve HbA1c ≤ 6.5 % (48 mmol/Mol) AACE Target (Yes/no)|Participants who achieved HbA1c ≤6.5% (48 mmol/mol) (American Association of Clinical Endocrinologists (AACE) target), at week 26 are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 26|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2547483|NCT02906930|Secondary|Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) ADA Target (Yes/no)|Participants who achieved HbA1c <7.0% (53 mmol/mol) (American Diabetes Association (ADA) target), at week 26 are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 26|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2547484|NCT02906930|Secondary|Change in Fasting Triglycerides - Ratio to Baseline|Change from baseline (week 0) to week 26 in triglycerides (mmol/L) is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio of fasting triglycerides||Geometric Coefficient of Variation|Geometric Mean
2547485|NCT02906930|Secondary|Change in Fasting HDL Cholesterol - Ratio to Baseline|Change from baseline (week 0) to week 26 in fasting high-density lipoprotein (HDL) cholesterol (mmol/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio of fasting HDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2547486|NCT02906930|Secondary|Change in Fasting LDL Cholesterol - Ratio to Baseline|Change from baseline (week 0) to week 26 in fasting low-density lipoprotein (LDL) cholesterol (mmol/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio of fasting LDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2547487|NCT02906930|Secondary|Change in Fasting Total Cholesterol - Ratio to Baseline|Change from baseline (week 0) to week 26 in fasting total cholesterol (mmol/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio of fasting total cholesterol||Geometric Coefficient of Variation|Geometric Mean
2547488|NCT02906930|Secondary|Change in Waist Circumference|Change from baseline (week 0) to week 26 in waist circumference. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||cm||Standard Deviation|Mean
2547489|NCT02906930|Secondary|Change in BMI|Change from baseline (week 0) to week 26 in body mass index (BMI). Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||kg/m^2||Standard Deviation|Mean
2551611|NCT02813577|Secondary|Number of Major Vascular Complications at 30 Days Post Index Procedure||30 days||||Complications|||Number
2547492|NCT02906930|Secondary|Change in HOMA-B (Beta-cell Function) - Ratio to Baseline|Change from baseline (week 0) to week 26 in homeostatic model assessment index of beta-cell function (HOMA-B) (%) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio of HOMA-B||Geometric Coefficient of Variation|Geometric Mean
2547493|NCT02906930|Secondary|Change in HOMA-IR (Insulin Resistance) - Ratio to Baseline|Change from baseline (week 0) to week 26 in homeostatic model assessment index of insulin resistance (HOMA-IR) (%) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio of HOMA-IR||Geometric Coefficient of Variation|Geometric Mean
2547494|NCT02906930|Secondary|Change in Fasting Glucagon - Ratio to Baseline|Change from baseline (week 0) to week 26 in fasting glucagon (pg/mL) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio of fasting glucagon||Geometric Coefficient of Variation|Geometric Mean
2547495|NCT02906930|Secondary|Change in Fasting Pro-insulin - Ratio to Baseline|Change from baseline (week 0) to week 26 in fasting pro-insulin (pmol/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio of fasting pro-insulin||Geometric Coefficient of Variation|Geometric Mean
2547496|NCT02906930|Secondary|Change in Fasting Insulin - Ratio to Baseline|Change from baseline (week 0) to week 26 in fasting insulin (pmol/L) is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio of fasting insulin||Geometric Coefficient of Variation|Geometric Mean
2547497|NCT02906930|Secondary|Change in Mean Postprandial Increment Over All Meals in SMPG|Change from baseline (week 0) to week 26 in the average of the post-prandial increments over all meals. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2547498|NCT02906930|Secondary|Change in Mean 7-point SMPG Profile|Change from baseline (week 0) to week 26 in mean 7-point self-measured plasma glucose (SMPG) profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2547499|NCT02906930|Secondary|Change in Fasting Plasma Glucose|Change from baseline (week 0) to week 26 in fasting plasma glucose. The endpoint was evaluated based on data from the in-trial observation period. The in-trial observation period - time period from when a subject was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2547500|NCT02906930|Secondary|Change in Body Weight (kg)|Change from baseline (week 0) to week 26 in body weight. The endpoint was evaluated based on data from the in-trial observation period. The in-trial observation period - time period from when a subject was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. The primary endpoint was also analysed based on data from the on-treatment without rescue medication observation period. The on-treatment without rescue medication observation period - time period when a subject was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||kg||Standard Deviation|Mean
2547501|NCT02906930|Primary|Change in HbA1c|Change from baseline (week 0) to week 26 in glycosylated haemoglobin (HbA1c). The endpoint was evaluated based on data from the in-trial observation period. The in-trial observation period - time period from when a subject was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. The primary endpoint was also analysed based on data from the on-treatment without rescue medication observation period. The on-treatment without rescue medication observation period - time period when a subject was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2547517|NCT02906813|Secondary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)||Baseline up to 30 days after last dose of study drug (Day 39)|The safety analysis set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
2547502|NCT02906917|Secondary|Incidence of TEAEs|Number of treatment emergent adverse events (TEAEs) were analysed during the following periods: weeks 0-26, weeks 26-38 and weeks 0-38. Treatment emergent: An adverse event that had an onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. If an event had an onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period, or if it had an onset date within 7 days after the last drug date, then this event was also to be considered as a TEAE.|Weeks 0-26, weeks 26-38, weeks 0-38|Safety analysis set, which included all subjects receiving at least one dose of the investigational product (IDegAsp) or comparator (IGlar). Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.|||Events|||Number
2547503|NCT02906917|Secondary|Change in Body Weight|Change from baseline (week 0) in body weight was evaluated 26 and 38 weeks after randomisation, respectively.|Week 0, week 26, week 38|Safety analysis set, which included all subjects receiving at least one dose of the investigational product or comparator. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.|||Kg||Standard Deviation|Mean
2547504|NCT02906917|Secondary|Total Insulin Dose|Total insulin dose was evaluated 26 and 38 weeks after randomisation, respectively.|Week 26 and week 38|Safety analysis set, which included all subjects receiving at least one dose of the investigational product or comparator. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.|||Units||Standard Deviation|Mean
2547505|NCT02906917|Secondary|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes|Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were analysed during the following periods: weeks 0-26, weeks 16-26 and weeks 0-38. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product.|Weeks 0-26, weeks 16-26, weeks 0-38|Safety analysis set, which included all subjects receiving at least one dose of the investigational product or comparator. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.|||Episodes|||Number
2547506|NCT02906917|Secondary|Number of Nocturnal, Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes|Number of nocturnal, treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were analysed during the following periods: weeks 0-26, weeks 16-26 and weeks 0-38. Nocturnal hypoglycaemic episodes: episodes occurring between 00:01 and 05:59 both inclusive. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product.|Weeks 0-26, weeks 16-26, weeks 0-38|Safety analysis set, which included all subjects receiving at least one dose of the investigational product (IDegAsp) or comparator (IGlar). Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.|||Episodes|||Number
2547507|NCT02906917|Secondary|Change in Postprandial SMPG Increment (From 9-point Profile)|Change from baseline (week 0) in postprandial SMPG increment (from 9-point profile) was evaluated 26 and 38 weeks after randomisation, respectively. 9-point SMPG profiles were measured starting in the morning 2 days prior to the scheduled visit at the time points described below: 1) Before breakfast (2 days prior to visit) 2) 90 minutes after start of the breakfast 3) Before lunch 4) 90 minutes after start of the lunch 5) Before dinner/main evening meal 6) 90 minutes after start of the dinner/main evening meal 7) At bedtime (2 days or 1 day prior to visit depending on actual clock time) 8) At 4 a.m. (1 day prior to visit) 9) Before breakfast at the following day (1 day prior to the visit).|Week 0, week 26, week 38|FAS, which included all randomised subjects. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.|||mg/dL||Standard Deviation|Mean
2547508|NCT02906917|Secondary|Change in Pre-breakfast SMPG (Used for Titration)|Reported results are observed pre-breakfast self-measured plasma glucose (SMPG; used for titration) values at week 1 (baseline) and 26 and 38 weeks after randomisation.|Week 1, week 26, week 38|FAS, which included all randomised subjects. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.|||mg/dL||Standard Deviation|Mean
2547509|NCT02906917|Secondary|Change in FPG|Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated 26 and 38 weeks after randomisation, respectively.|Week 0, week 26, week 38|FAS, which included all randomised subjects. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.|||mg/dL||Standard Deviation|Mean
2547510|NCT02906917|Secondary|Responder (Yes/No) for HbA1c <7% Without Severe or BG Confirmed Symptomatic Hypoglycaemia|Participants achieving (yes/no) HbA1c <7% without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia, was evaluated 26 and 38 weeks after randomisation, respectively. Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.|Week 26 and week 38|FAS, which included all randomised subjects. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.|||Number of participants|||Number
2547511|NCT02906917|Secondary|Responder (Yes/No) for HbA1c < 7%|Participants achieving (yes/no) HbA1c <7% was evaluated 26 and 38 weeks after randomisation, respectively.|Week 26 and week 38|FAS, which included all randomised subjects. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.|||Number of participants|||Number
2547512|NCT02906917|Secondary|Change in HbA1c (%) - Week 38|Change from baseline (week 0) in HbA1c was evaluated 38 weeks after randomisation.|Week 0, week 38|FAS, which included all randomised subjects. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.|||% of HbA1c||Standard Deviation|Mean
2547513|NCT02906917|Primary|Change in HbA1c (%) - Week 26|Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated 26 weeks after randomisation.|Week 0, week 26|FAS, which included all randomised subjects. Number of subjects analyzed = number of subjects contributed to the analysis at specified time point.|||% of HbA1c||Standard Deviation|Mean
2547518|NCT02906813|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK analysis set where data on Day 1 was available. The PK set included all participants who were enrolled, received study drug and had at least 1 measurable plasma concentration for either TAK-935 or its M-I.|||ng*hr/mL||Standard Deviation|Mean
2547519|NCT02906813|Primary|AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The PK set included all participants who were enrolled, received study drug and had at least 1 measurable plasma concentration for either TAK-935 or its M-I.|||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
2547520|NCT02906813|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-935||Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|The pharmacokinetic (PK) set included all participants who were enrolled, received study drug and had at least 1 measurable plasma concentration for either TAK-935 or its metabolite (M-I).|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2547521|NCT02906709|Secondary|Percentage of Participants Achieving Hemoglobin A1c Goals (<6.5%) at Week 52 (Phase A+B)|HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. For the HbA1c goals of <6.5% at Week 52, the percentage of participants and the 95% confidence intervals were calculated using Wilson score method by treatment groups of the double-blind period.|Week 52|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one measurement (baseline or post randomization). Three participants in the Placebo group did not have data to contribute to the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2547522|NCT02906709|Secondary|Percentage of Participants Achieving Hemoglobin A1c Goals (<7.0%) at Week 52 (Phase A+B)|HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. For the HbA1c goals of <7.0% at Week 52, the percentage of participants and the 95% confidence intervals were calculated using Wilson score method by treatment groups of the double-blind period.|Week 52|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one measurement (baseline or post randomization). Three participants in the Placebo group did not have data to contribute to the analysis.|||Percentage of Participants||95% Confidence Interval|Number
2547523|NCT02906709|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 (Phase A+B)|Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 52 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 52 minus FPG at baseline). Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Negative data values indicated a reduction in FPG levels.|Baseline (Day 1) and Week 52|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one measurement (baseline or post randomization) for the outcome measure. Three participants in the Placebo group did not have data to contribute to the analysis.|||mg/dL||95% Confidence Interval|Mean
2547524|NCT02906709|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52 (Phase A+B)|HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Participant whole blood samples were collected at baseline and Week 52 to determine the mean HbA1c change from baseline (i.e., HbA1c at Week 52 minus HbA1c at baseline). Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Negative data values indicated a reduction in HbA1c levels.|Baseline (Day 1) and Week 52|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one measurement (baseline or post randomization) for the outcome measure. Three participants in the Placebo group did not have data to contribute to the analysis.|||Percent A1C||95% Confidence Interval|Mean
2547525|NCT02906709|Secondary|Constrained Longitudinal Data Analysis of Change From Baseline in 1,5-anhydroglucitol (1,5-AG) at Week 16 Excluding Data After Glycemic Rescue (Phase A)|1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis. Data (1,5-AG at Week 16 minus 1,5-AG at baseline) was analyzed by Constrained Longitudinal Data Analysis. Positive data values indicate an increase in 1,5-AG levels and correlate with an improvement in glycemia.|Baseline (Day 1) and Week 16|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one measurement (baseline or post randomization) for the outcome measure.|||mg/L||95% Confidence Interval|Least Squares Mean
2547526|NCT02906709|Secondary|Percentage of Participants Achieving HbA1c Goals (<6.5%) at Week 16 Constrained Longitudinal Data Analysis Using Multiple Imputation Excluding Data After Glycemic Rescue (Phase A)|HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis. Each of the 10 imputed data sets was summarized to obtain the percentage of responders within each group and were combined using standard multiple imputation techniques to yield an overall estimate of response rate and associated variance for each group. A constrained longitudinal data analysis was used to analyze the data and Wilson score method by treatment groups used for the analysis of percentages of individuals at the HbA1c goals of <6.5% at Week 16 and the 95% confidence intervals (CIs). Miettinen & Nurminen (M&N) method after imputations were used to calculate the treatment differences of the percentages of individuals and the 95% CIs.|Week 16|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one measurement (baseline or post randomization) for the outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
2552115|NCT02799069|Secondary|Local Discomfort During First Photodynamic Therapy (PDT-1)|Local discomfort reported by the patients during Illumination of first PDT (PDT1)|during PDT treatment [3 h - 4 h ]|Safety Population|||percentage of patients|||Number
2547527|NCT02906709|Secondary|Percentage of Participants Achieving Hemoglobin A1c Goals (<7.0%) at Week 16 Constrained Longitudinal Data Analysis Using Multiple Imputation Excluding Data After Glycemic Rescue (Phase A)|HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis. Each of the 10 imputed data sets was summarized to obtain the percentage of responders within each group and were combined using standard multiple imputation techniques to yield an overall estimate of response rate and associated variance for each group. A constrained longitudinal data analysis was used to analyze the data and Wilson score method by treatment groups used for the analysis of percentages of individuals at the HbA1c goals of <7.0% at Week 16 and the 95% confidence intervals (CIs). Miettinen & Nurminen (M&N) method after imputations were used to calculate the treatment differences of the percentages of individuals and the 95% CIs.|Week 16|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one measurement (baseline or post randomization) for the outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
2547528|NCT02906709|Secondary|Constrained Longitudinal Data Analysis of Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16 Excluding Data After Glycemic Rescue (Phase A)|Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 16 weeks of treatment to determine Constrained Longitudinal Data Analysis change in plasma glucose levels (i.e., FPG at Week 16 minus FPG at baseline). Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis. Negative data values indicated a reduction in FPG levels.|Baseline (Day 1) and Week 16|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one measurement (baseline or post randomization) for the outcome measure.|||mg/dL||95% Confidence Interval|Least Squares Mean
2547529|NCT02906709|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE Including Data After Glycemic Rescue (Omarigliptin [Phase A+B]; Placebo→Omarigliptin [Phase B Only])|An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. The results for the Placebo→Omarigliptin group summarized data from the open label period only (36 weeks), which corresponds to the study interval in which those participants were exposed to omarigliptin.|Up to Week 52|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified measurement and timeframe.|||Percentage of Participants|||Number
2547530|NCT02906709|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE Excluding Data After Glycemic Rescue (Phase A)|An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis.|Up to Week 16|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified measurement and timeframe.|||Percentage of Participants|||Number
2547531|NCT02906709|Primary|Percentage of Participants Who Experienced One or More AE (Omarigliptin [Phase A+B]; Placebo→Omarigliptin [Phase B Only])|An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. The results for the Placebo→Omarigliptin group summarized data from the open label period only (36 weeks), which corresponds to the study interval in which those participants were exposed to omarigliptin.|Up to Week 52|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified measurement and timeframe.|||Percentage of Participants|||Number
2547532|NCT02906709|Primary|Percentage of Participants Who Experienced One or More Adverse Events (AE) Excluding Data After Glycemic Rescue (Phase A)|An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis.|Up to Week 16|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had safety data for the specified measurement and timeframe.|||Percentage of participants|||Number
2547589|NCT02906579|Primary|Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Insulin at Discharge Day (Day 19)|Study baseline is defined as the Day -1 assessment.|Baseline, Day 19|Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.|||µIU/mL||Standard Deviation|Mean
2549587|NCT02849990|Secondary|Number of Patients With a Negative Margin After 3 Months of Treatment|The absence of tumor cells at the prostate margin will be assessed using standard pathological practices on prostatectomy specimens (i.e. after 3 months of treatment).|At 3 months||||Participants|||Count of Participants
2547533|NCT02906709|Primary|Constrained Longitudinal Data Analysis of Change From Baseline in Hemoglobin A1c (HbA1c) at Week 16 Excluding Data After Glycemic Rescue (Phase A)|HbA1c is a measure of the percentage of glycated hemoglobin in the blood. Participant whole blood samples were collected at baseline and Week 16 to determine the Constrained Longitudinal Data Analysis least squares mean HbA1c change from baseline (i.e., HbA1c at Week 16 minus HbA1c at baseline). Participants that met rescue criteria had their insulin dose adjusted as determined clinically appropriate by the investigator to manage glycemic control. Data after glycemic rescue were excluded from this analysis. Negative data values indicated a reduction in HbA1c levels.|Baseline (Day 1) and Week 16|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one measurement (baseline or post randomization) for the outcome measure.|||Percent HbA1c||95% Confidence Interval|Least Squares Mean
2547534|NCT02906696|Secondary|Change of ABL Kinase Domain Mutation Status|Will be summarized and its association with survival outcomes will be analyzed through landmark analyses. Cox proportional hazards regression models will be fit to assess the association between patient characteristics including ABL kinase domain mutation status.|Baseline up to 2 years|There were not any at the start of treatment so there were not any mutation status to follow. These were not done.||||||
2547535|NCT02906696|Secondary|Transformation-free Survival|Will be assessed by Kaplan-Meier methods. Transformation-free survival is defined as the time from treatment initiation until either progression to AP/BP or death from any cause.|Up to 2 years||||Months||Full Range|Median
2547536|NCT02906696|Secondary|Event-free Survival|Time from date of treatment start until the date of first objective documentation of disease-relapse.|Up to 2 years||||Months||Full Range|Median
2547537|NCT02906696|Secondary|Overall Survival|Will be assessed by Kaplan-Meier methods. Cox proportional hazards regression models will be fit to assess the association between patient characteristics including survival outcome. Time from date of treatment start until date of death due to any cause or last Follow-up.|Up to 2 years||||Months||Full Range|Median
2547538|NCT02906696|Secondary|Rates of BCR-ABL/ABL < 1%|Will be assessed using the international scale. Will be estimated along with the exact 95% confidence intervals.|At 6 months||||Participants|||Count of Participants
2547539|NCT02906696|Secondary|Rates of BCR-ABL/ABL <10%|Will be assessed using the international scale. Will be estimated along with the exact 95% confidence intervals.|At 3 months||||Participants|||Count of Participants
2547540|NCT02906696|Secondary|Rates of Major Molecular Response (MR), MR4, MR4.5 and Complete Molecular Response|Will be estimated along with the exact 95% confidence intervals. Molecular assessments are based on quantitative reverse transcriptase polymerase chain reaction for Bcr-Abl in peripheral blood. Molecular response is categorized as MMR (Bcr-Abl/Abl ratio of </= 0.1% in the international scale), MR4 (Bcr-Abl/Abl </= 0.01%), and MR4.5 (BCR-ABL/ABL </=0.0032%).|Up to 2 years||||Participants|||Count of Participants
2547541|NCT02906696|Secondary|Frequency of Treatment Interruptions and Dose Reductions|Will be summarized.|Up to 2 years||||Participants|||Count of Participants
2547542|NCT02906696|Primary|Response Rate|Response is defined as follows: 1) For patients who do not currently have a partial cytogenetic response (PCyR), achievement of major cytogenetic response is considered a response. 2) For patients who are currently in PCyR, achievement of CCyR is considered a response. The Simon's optimal two-stage design will be used for interim futility monitoring. Will be estimated along with the 95% credible interval.|Up to 6 months||||Participants|||Count of Participants
2547543|NCT02906644|Secondary|Adherence to Lorcaserin + Nicotine Patch Treatment as Indicator of Tolerability|Tolerability of the lorcaserin + nicotine patch treatment will be assessed by calculating adherence scores based on the percentage of days on which the study drugs were taken between visits as reported by participants on diaries.|Two Weeks pre and 10 weeks post quit day|Two weeks pre-quit day, all study subjects were switched to taking active lorcaserin for the duration of the study. Fourteen subjects either dropped out prior to Visit 3 (the first visit after all subjects were on combined treatment) or had missing or incomplete diaries, so data are only available for 47 subjects during this phase of the study.|||percentage of days using study drugs||Standard Deviation|Mean
2547544|NCT02906644|Secondary|Percentage of Change in Ad Libitum Smoking at End of Week 2|To evaluate the effects of lorcaserin on ad libitum (ad lib) smoking, the percent change in reported number of cigarettes smoked from baseline to the end of week 2 (the day prior to the 2nd study visit) will be calculated.|Week 2 pre quit day|There are insufficient data for 9 participants in the Lorcaserin + Patch group and for 8 participants in the Patch only group (due to participant dropout or incomplete or unreturned diaries) so this analysis excluded those individuals.|||percentage of change||Standard Deviation|Mean
2547545|NCT02906644|Secondary|Number of Participants Reporting 6-month Smoking Abstinence|Number of participants who reported not smoking for the previous seven days when called for 6-month follow-up, confirmed by expired air carbon monoxide (CO).|6 months post Quit Day|Two weeks pre-quit day, all study subjects were switched to taking active lorcaserin for the duration of the study. Nine participants reported continuous 7-day abstinence from smoking 6 months post quit-day, confirmed by expired air carbon monoxide (CO).|||Participants|||Count of Participants
2547546|NCT02906644|Secondary|Weight Gain Following Continuous Four-week Abstinence From Smoking|Among smoking-abstinent participants, weight gain relative to baseline will be assessed.|Week 10 post quit day|Two weeks pre-quit day, all study subjects were switched to taking active lorcaserin for the duration of the study. Nineteen participants reported continuous four-week abstinence from smoking (weeks 7-10 post target quit date), confirmed by expired air carbon monoxide (CO).|||weight gain (in lbs)||Standard Deviation|Mean
2547547|NCT02906644|Secondary|Number of Participants Reporting Tolerability Issues With Lorcaserin + Nicotine Patch Treatment|"Tolerability of the lorcaserin + nicotine patch treatment will be assessed by tabulating the number of participants rating side effects > moderate."|Two Weeks pre and 10 weeks post quit day|Two weeks pre-quit day, all study subjects were switched to taking active lorcaserin for the duration of the study. Twelve participants dropped out of the study prior to the next study visit, therefore side effects data from 2 weeks pre-quit to the end of the study are only available for 49 participants.|||Participants|||Count of Participants
2547548|NCT02906644|Secondary|Number of Participants Reporting Smoking Abstinence|Number of participants who reported continuous four-week abstinence from smoking (weeks 7-10 post target quit date), confirmed by expired air carbon monoxide (CO).|Weeks 7-10 post quit day||||Participants|||Count of Participants
2547549|NCT02906644|Primary|Smoking Withdrawal|At the study visit above (two week post treatment initiation but 2 weeks prior to quit day), withdrawal symptoms will be assessed after 2 hours of smoking abstinence using the Shiffman-Jarvik (short form) questionnaire, which consists of 9 items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 9 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, and Arousal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.|Week 2 pre quit day|Four participants dropped out of the study, 3 more reported having already quit smoking before the Smoking Lapse Task occurred, and 1 did not complete the withdrawal questionnaire; therefore, we have lapse data for only 53 participants rather than 61.|||score on a scale||Standard Deviation|Mean
2547550|NCT02906644|Primary|Time-to-lapse|Two weeks after treatment is initiated, with nicotine patch + lorcaserin or nicotine patch alone, but still two weeks prior to the quit day, subjects will be evaluated in a modified version of the McKee Smoking Lapse Task. In this task smokers, who have been abstinent for 2 hours will be provided with the option to smoke at any time, but paid by the minute for remaining abstinent with progressively decreasing payments over an hour.|Week 2 pre quit day|Four participants dropped out of the study and 3 more reported having already quit smoking before the Smoking Lapse Task occurred; therefore, we have lapse data for only 54 participants rather than 61.|||Minutes||Standard Deviation|Mean
2547551|NCT02906579|Primary|Change From Time-Matched Baseline (Placebo Cycle) in Platelet Function Assessments: Collagen/Epinephrine Time to Aggregation|"Time-matched baseline is defined as the corresponding assessment on Day 1 of the placebo cycle.~Platelet function assessment used the PFA-100® instrument to evaluate collagen/epinephrine time to aggregation.~Baseline is designated per protocol as Day 1 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 1 of each IW-1973 dose at given time point are presented as the second row of data."|Time-Matched Baseline (Placebo Cycle), Cycle Day 1, 0 h, Cycle Day 1, 4 h|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||secs||Standard Deviation|Mean
2547552|NCT02906579|Primary|Change From Pre- to Post-Nitroglycerin Dose Assessment in Endothelial Function: RHI|Endothelial function was assessed by RHI value determined using the noninvasive EndoPAT™ (Itamar Medical; Caesarea, Israel) device. RHI is a validated measure of endothelial function, with a higher RHI indicating better endothelial function compared to a lower value. The full EndoPAT 2000 user manual (software version 3.7.x) recommends using RHI values >1.67 as a cutoff for normal endothelial function, with values ≤1.67 indicating endothelial dysfunction.|Follow-up Visit Day 32 (± 2 days)|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment.|||units on a scale||Standard Deviation|Mean
2547553|NCT02906579|Primary|Change From Time-Matched Baseline (Placebo Cycle) Over Time in Endothelial Function: RHI|"Time-matched baseline for each timepoint is defined as the corresponding assessment during the placebo cycle.~Endothelial function was assessed by RHI value determined using the noninvasive EndoPAT™ (Itamar Medical; Caesarea, Israel) device. RHI is a validated measure of endothelial function, with a higher RHI indicating better endothelial function compared to a lower value. The full EndoPAT 2000 user manual (software version 3.7.x) recommends using RHI values >1.67 as a cutoff for normal endothelial function, with values ≤1.67 indicating endothelial dysfunction.~Baseline is designated per protocol as Day 3 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 3 of each IW-1973 dose at given time point are presented as the second row of data."|Time-matched Baseline (Placebo Cycle); Cycle Day 3: 0 h, 4 h, 12 h|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
2547554|NCT02906579|Primary|Change From Study Baseline Over Time in Endothelial Function: Reactive Hyperemia Index (RHI)|"Study baseline is defined as the Day -1 assessment.~Endothelial function was assessed by RHI value determined using the noninvasive EndoPAT™ (Itamar Medical; Caesarea, Israel) device. RHI is a validated measure of endothelial function, with a higher RHI indicating better endothelial function compared to a lower value. The full EndoPAT 2000 user manual (software version 3.7.x) recommends using RHI values >1.67 as a cutoff for normal endothelial function, with values ≤1.67 indicating endothelial dysfunction."|Study Baseline; Cycle Day 3: 0 h, 4 h, 12 h|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
2547555|NCT02906579|Primary|Change From Pre- to Post-Nitroglycerin Dose Assessment in Supine Diastolic Blood Pressure||Follow-up Visit Day 32 (± 2 days)|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment.|||mmHg||Standard Deviation|Mean
2547556|NCT02906579|Primary|Change From Pre- to Post-Nitroglycerin Dose Assessment in Supine Systolic Blood Pressure||Follow-up Visit Day 32 (± 2 days)|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment.|||mmHg||Standard Deviation|Mean
2547557|NCT02906579|Primary|Change From Pre- to Post-Nitroglycerin Dose Assessment in Supine Pulse||Follow-up Visit Day 32 (± 2 days)|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment.|||bpm||Standard Deviation|Mean
2547558|NCT02906579|Primary|Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Pulse|"Daytime average is the average of ABPM assessments over 12 hours from the time of dosing. Time-matched baseline is the daytime average during the placebo cycle (Day 2).~Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment). To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose are presented as the second row of data."|Time-Matched Baseline (Placebo Cycle); Cycle Day 2|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||mmHg||Standard Deviation|Mean
2547902|NCT02896361|Secondary|Subject Preference|"questionnaire to identify preferred stimulation paradigm. multiple choice questionnaire. Possible answers were~first intervention~second intervention~third intervention~no preference"|assessed 6 weeks after baseline at the last follow up visit||||Participants|||Count of Participants
2547559|NCT02906579|Primary|Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Pulse|"Thirty-minute average is the average of ABPM assessments over 30 minutes intervals from the time of dosing. Time-matched baseline is the 30 minutes average during the placebo cycle (Day 2).~Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data."|Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, 10 hrs, 10.5 hrs, 11 hrs, 11.5 hrs, 12 hrs|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||mmHg||Standard Deviation|Mean
2547560|NCT02906579|Primary|Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Pulse|"Four-hour average is the average of ABPM assessments over 4 hours intervals from the time of dosing. Time-matched baseline is the 4 hours average during the placebo cycle (Day 2).~Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data."|Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0-4 hrs, 4-8 hrs, 8-12 hrs|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||mmHg||Standard Deviation|Mean
2547561|NCT02906579|Primary|Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Mean Arterial Pressure|"Daytime average is the average of ABPM assessments over 12 hours from the time of dosing. Time-matched baseline is the daytime average during the placebo cycle (Day 2).~Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment). To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose are presented as the second row of data."|Time-Matched Baseline (Placebo Cycle); Cycle Day 2|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||mmHg||Standard Deviation|Mean
2547562|NCT02906579|Primary|Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Mean Arterial Pressure|"Thirty-minute average is the average of ABPM assessments over 30 minutes intervals from the time of dosing. Time-matched baseline is the 30 minutes average during the placebo cycle (Day 2).~Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data."|Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, 10 hrs, 10.5 hrs, 11 hrs, 11.5 hrs, 12 hrs|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||mmHg||Standard Deviation|Mean
2547563|NCT02906579|Primary|Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Mean Arterial Pressure|"Four-hour average is the average of ABPM assessments over 4 hours intervals from the time of dosing. Time-matched baseline is the 4 hours average during the placebo cycle (Day 2).~Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data."|Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0-4 hrs, 4-8 hrs, 8-12 hrs|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||mmHg||Standard Deviation|Mean
2547564|NCT02906579|Primary|Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Diastolic Blood Pressure|"Daytime average is the average of ABPM assessments over 12 hours from the time of dosing. Time-matched baseline is the daytime average during the placebo cycle (Day 2).~Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment). To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose are presented as the second row of data."|Time-Matched Baseline (Placebo Cycle); Cycle Day 2|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||mmHg||Standard Deviation|Mean
2547565|NCT02906579|Primary|Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Diastolic Blood Pressure|"Thirty-minute average is the average of ABPM assessments over 30 minutes intervals from the time of dosing. Time-matched baseline is the 30 minutes average during the placebo cycle (Day 2).~Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data."|Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, 10 hrs, 10.5 hrs, 11 hrs, 11.5 hrs, 12 hrs|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||mmHg||Standard Deviation|Mean
2547590|NCT02906579|Primary|Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Hemoglobin A1c at Follow-Up (Day 32)|Study baseline is defined as the Day -1 assessment.|Baseline, Day 32|Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.|||percent||Standard Deviation|Mean
2547903|NCT02896361|Secondary|EQ-5D|European Quality of life questionnaire 5 dimensions. Range goes from 0 to 1. 0 represents low quality of life, 1 represents high quality of life|assessed every 2 weeks after each intervention, for a total of 6 weeks||||score on a scale||Standard Deviation|Mean
2547566|NCT02906579|Primary|Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 4-Hour Averages of Diastolic Blood Pressure|"Four-hour average is the average of ABPM assessments over 4 hours intervals from the time of dosing. Time-matched baseline is the 4 hours average during the placebo cycle (Day 2).~Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data."|Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0-4 hrs, 4-8 hrs, 8-12 hrs|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||mmHg||Standard Deviation|Mean
2547567|NCT02906579|Primary|Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM Daytime (12-Hour) Averages of Systolic Blood Pressure|"Daytime average is the average of ABPM assessments over 12 hours from the time of dosing. Time-matched baseline is the daytime average during the placebo cycle (Day 2).~Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data."|Time-Matched Baseline (Placebo Cycle); Cycle Day 2|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||mmHg||Standard Deviation|Mean
2547568|NCT02906579|Primary|Change From Time-Matched Baseline (Placebo Cycle) Over Time in ABPM 30 Minute Averages of Systolic Blood Pressure|"Thirty-minute average is the average of ABPM assessments over 30 minutes intervals from the time of dosing. Time-matched baseline is the 30 minutes average during the placebo cycle (Day 2).~Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data."|Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, 10 hrs, 10.5 hrs, 11 hrs, 11.5 hrs, 12 hrs|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||mmHg||Standard Deviation|Mean
2547569|NCT02906579|Primary|Change From Time-Matched Baseline (Placebo Cycle) Over Time in Ambulatory Blood Pressure Monitoring (ABPM) 4-Hour Averages of Systolic Blood Pressure|"Four-hour average is the average of ABPM assessments over 4 hours intervals from the time of dosing. Time-matched baseline is the 4 hours average during the placebo cycle (Day 2).~Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose at given time point are presented as the second row of data."|Time-Matched Baseline (Placebo Cycle); Cycle Day 2: 0-4 hrs, 4-8 hrs, 8-12 hrs|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||mmHg||Standard Deviation|Mean
2547570|NCT02906579|Primary|Orthostatic Diastolic Blood Pressure Over Time|An orthostatic measurement is obtained by subtracting the supine measurement from the standing measurement.|Cycle Day 1, Predose; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||mmHg||Standard Deviation|Mean
2547571|NCT02906579|Primary|Orthostatic Systolic Blood Pressure Over Time|An orthostatic measurement is obtained by subtracting the supine measurement from the standing measurement.|Cycle Day 1, Predose; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||mmHg||Standard Deviation|Mean
2547572|NCT02906579|Primary|Orthostatic Pulse Over Time|An orthostatic measurement is obtained by subtracting the supine measurement from the standing measurement.|Cycle Day 1, Predose; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||bpm||Standard Deviation|Mean
2547573|NCT02906579|Primary|Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Diastolic Blood Pressure|"Time-matched baseline for each timepoint is defined as the corresponding assessment during the placebo cycle.~Baseline is designated per protocol as Day 1 or 3 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 1 or 3 of each IW-1973 dose at given time point are presented as the second row of data."|Time-Matched Baseline (Placebo Cycle); Cycle Day 1, 0 h; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h; Cycle Day 3, 0 h; Cycle Day 3, 1 h; Cycle Day 3, 2 h; Cycle Day 3, 8 h|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||mmHg||Standard Deviation|Mean
2547574|NCT02906579|Primary|Change From Study Baseline Over Time in Supine Diastolic Blood Pressure|Study baseline is defined as the Day -1 assessment.|Study Baseline; Cycle Day 1, 0 h; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h; Cycle Day 3, 0 h; Cycle Day 3, 1 h; Cycle Day 3, 2 h; Cycle Day 3, 8 h|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||mmHg||Standard Deviation|Mean
2547587|NCT02906579|Primary|Change From Time-Matched Baseline in Fasting Blood Glucose on Day 2 of Each Dose Cycle|"Time-matched baseline is defined as the corresponding assessment on Day 2 of the placebo cycle.~Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment). To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose are presented as the second row of data."|Time-Matched Baseline (Day 2 Placebo Cycle), Day 2 of Each Dose Cycle (Days 5, 8, 11, 14, 17)|Pharmacodynamic (PD) Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment.|||mg/dL||Standard Deviation|Mean
2547575|NCT02906579|Primary|Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Systolic Blood Pressure|"Time-matched baseline for each timepoint is defined as the corresponding assessment during the placebo cycle.~Baseline is designated per protocol as Day 1 or 3 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 1 or 3 of each IW-1973 dose at given time point are presented as the second row of data."|Time-Matched Baseline (Placebo Cycle); Cycle Day 1, 0 h; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h; Cycle Day 3, 0 h; Cycle Day 3, 1 h; Cycle Day 3, 2 h; Cycle Day 3, 8 h|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||mmHg||Standard Deviation|Mean
2547576|NCT02906579|Primary|Change From Study Baseline Over Time in Supine Systolic Blood Pressure|Study baseline is defined as the Day -1 assessment.|Study Baseline; Cycle Day 1, 0 h; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h; Cycle Day 3, 0 h; Cycle Day 3, 1 h; Cycle Day 3, 2 h; Cycle Day 3, 8 h|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||mmHg||Standard Deviation|Mean
2547577|NCT02906579|Primary|Change From Time-Matched Baseline (Placebo Cycle) Over Time in Supine Pulse|"Time-matched baseline for each timepoint is defined as the corresponding assessment during the placebo cycle.~Baseline is designated per protocol as Day 1 or 3 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment) at given time point. To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 1 or 3 of each IW-1973 dose at given time point are presented as the second row of data."|Time-Matched Baseline (Placebo Cycle); Cycle Day 1, 0 h; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h; Cycle Day 3, 0 h; Cycle Day 3, 1 h; Cycle Day 3, 2 h; Cycle Day 3, 8 h|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||bpm||Standard Deviation|Mean
2547578|NCT02906579|Primary|Change From Study Baseline Over Time in Supine Pulse|Study baseline is defined as the Day -1 assessment.|Study Baseline; Cycle Day 1, 0 h; Cycle Day 1, 1 h; Cycle Day 1, 2 h; Cycle Day 1, 4 h; Cycle Day 1, 8 h; Cycle Day 1, 12 h; Cycle Day 3, 0 h; Cycle Day 3, 1 h; Cycle Day 3, 2 h; Cycle Day 3, 8 h|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment with an assessment at given time point.|||bpm||Standard Deviation|Mean
2547579|NCT02906579|Primary|Number of Participants With Clinically Significant Findings or Shifts in Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF)||Study Baseline, Cycle Day 1: 0 (≤ 15m) predose; 1h, 4h (± 15m) postdose; Day 19|Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.|||Participants|||Count of Participants
2547580|NCT02906579|Primary|Number of Participants With Clinically Significant Findings or Shifts in Baseline in Electrocardiograms (ECGs)||Study Baseline, Cycle Day 1: 0 (≤ 15m) predose; 1h, 4h (± 15m) postdose; Day 19|Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.|||Participants|||Count of Participants
2547581|NCT02906579|Primary|Change From Baseline Over Time in Weight||Baseline, Day 19, Day 32|Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.|||kg||Standard Deviation|Mean
2547582|NCT02906579|Primary|Change From Baseline Over Time in Temperature||Baseline, Day 19, Day 32|Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.|||degrees celcius||Standard Deviation|Mean
2547583|NCT02906579|Primary|Change From Baseline Over Time in Respiratory Rate||Baseline, Day 19, Day 32|Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.|||breaths/min||Standard Deviation|Mean
2547584|NCT02906579|Primary|Number of Participants With Notable Post Baseline Orthostatic Vital Signs Values|Systolic blood pressure (SBP): Decrease of > 20 mmHg from supine to standing Diastolic blood pressure (DBP): Decrease of > 10 mmHg from supine to standing Pulse rate (PR): Increase of > 20 bpm from supine to standing.|Up to Day 32|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment|||Participants|||Count of Participants
2547585|NCT02906579|Primary|Number of Participants With Notable Changes in Post Baseline Vital Signs Values|"Supine systolic blood pressure (SSBP):~≥ 180 mmHg and increase (↑) from baseline (BL) ≥ 30 mmHg; ≤ 90 mmHg and decrease (↓) from BL ≥ 30 mmHg.~Supine Diastolic Blood Pressure (SDBP):~≥ 105 mmHg and ↑ from BL ≥ 20 mmHg; ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg.~Supine pulse rate (SPR):~≥ 110 beats per minute (bpm) and ↑ from BL ≥ 20 bpm; ≤ 50 bpm and ↓ from BL ≥ 20 bpm.~Standing systolic blood pressure (StSBP):~≥ 180 mmHg and increase (↑) from baseline (BL) ≥ 30 mmHg; ≤ 90 mmHg and decrease (↓) from BL ≥ 30 mmHg.~Standing Diastolic Blood Pressure (StDBP):~≥ 105 mmHg and ↑ from BL ≥ 20 mmHg; ≤ 50 mmHg and ↓ from BL ≥ 20 mmHg.~Standing pulse rate (StPR):~≥ 110 beats per minute (bpm) and ↑ from BL ≥ 20 bpm; ≤ 50 bpm and ↓ from BL ≥ 20 bpm."|Up to Day 32|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment|||Participants|||Count of Participants
2547586|NCT02906579|Primary|Change From Time-Matched Baseline in Serum Insulin on Day 2 of Each Dose Cycle|"Time-matched baseline is defined as the corresponding assessment on Day 2 of the placebo cycle.~Baseline is designated per protocol as Day 2 of the placebo cycle (Days 1-3; i.e., the first cycle of treatment). To present 'change from time-matched baseline' endpoints, the values for time-matched baseline are presented as the first row of data, and the changes at Day 2 of each IW-1973 dose are presented as the second row of data."|Time-Matched Baseline (Day 2 Placebo Cycle), Day 2 of Each Dose Cycle (Days 5, 8, 11, 14, 17)|PD Population: all participants who received ≥1 dose of study drug and had ≥1 postdose PD assessment.|||µIU/mL||Standard Deviation|Mean
2547588|NCT02906579|Primary|Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Insulin at Follow-Up (Day 32)|Study baseline is defined as the Day -1 assessment.|Baseline, Day 32|Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.|||µIU/mL||Standard Deviation|Mean
2549588|NCT02849990|Secondary|Apoptotic Index (i.e. Percentage of Tumor Cells Undergoing Apoptosis)|Will be determined by cleaved caspase-3 immunohistochemistry.|At 3 months|Due to limited post-treatment tumor tissue, assessment of apoptotic index is not feasible.||||||
2547591|NCT02906579|Primary|Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Hemoglobin A1c at Discharge Day (Day 19)|Study baseline is defined as the Day -1 assessment.|Baseline, Day 19|Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.|||percent||Standard Deviation|Mean
2547592|NCT02906579|Primary|Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in GGT and Lactate Dehydrogenase at Follow-Up (Day 32)|Study baseline is defined as the Day -1 assessment.|Baseline, Day 32|Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.|||U/L||Standard Deviation|Mean
2547593|NCT02906579|Primary|Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase at Discharge Day (Day 19)|Study baseline is defined as the Day -1 assessment.|Baseline, Day 19|Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.|||U/L||Standard Deviation|Mean
2547594|NCT02906579|Primary|Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Follow-Up (Day 32)|Study baseline is defined as the Day -1 assessment.|Baseline, Day 32|Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.|||mg/dL||Standard Deviation|Mean
2547595|NCT02906579|Primary|Certain Clinical Chemistry Laboratory Parameters: Overall Changes From Study Baseline in Cholesterol, Glucose, HDL-C, LDL-C, and Triglycerides at Discharge Day (Day 19)|Study baseline is defined as the Day -1 assessment.|Baseline, Day 19|Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.|||mg/dL||Standard Deviation|Mean
2547596|NCT02906579|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to TEAEs|An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with study treatment. An SAE is defined as any AE occurring at any dose that results in any of the following outcomes: death; life-threatening; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; important medical events. TEAEs are defined as those AEs that started or worsened in severity after the initiation of study drug administration.|From first dose of study drug through end of trial (Day 46 [±3 days])|Safety Population: all participants who received ≥1 dose of study drug, grouped according to actual study drug taken.|||Participants|||Count of Participants
2547597|NCT02906566|Primary|Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Younger Group Versus Older Group as Baseline)|Differences in transcript levels are reported as the number of genes that were upregulated or downregulated in the Younger Group participant tissue samples, as compared to a baseline provided by tissue samples collected from the Older Group (prior to their treatment).|Week 1|"Only the participants in Younger Group (ages 18-25) are included in the analysis, since a comparison of the baseline data for the Older Group (ages 55-75) against itself is not clinically meaningful."|||genes|genes||Number
2547598|NCT02906566|Secondary|Count of Participants With Skin and Subcutaneous Adverse Events as a Measure of Type and Severity of Adverse Events|Skin and subcutaneous adverse events were assessed for this outcome and documented and scored according to CTCAE version 4.03.|Baseline through week 12|"Participants in the Young Group Ages 18-25 attended a single study visit at week 1 to provide tissue samples for comparison purposes, and are not included in this analysis."|||Participants|||Count of Participants
2547599|NCT02906566|Secondary|Elasticity on Arm Skin|Elasticity was assessed using cutometry (R2 curve) as millimeters per second|Baseline; week 12|"Participants in the Young Group Ages 18-25 attended a single study visit at week 1 to provide tissue samples for comparison purposes, and are not included in this analysis."|||millimeters per second||Standard Deviation|Mean
2547600|NCT02906566|Secondary|Severity of Arm Skin Wrinkling|Wrinkling was assessed by the investigator using a 10-point Likert scale (range 0 to 9, lower scores correspond to less wrinkling).|Baseline; Week 12|"Participants in the Young Group Ages 18-25 attended a single study visit at week 1 to provide tissue samples for comparison purposes, and are not included in this analysis."|||units on a scale||Standard Deviation|Mean
2547601|NCT02906566|Secondary|Transepidermal Water Loss|Transepidermal Water Loss of arm skin was measured in units of grams/hours/meters squared.|Baseline; Week 12|"Participants in the Young Group Ages 18-25 attended a single study visit at week 1 to provide tissue samples for comparison purposes, and are not included in this analysis."|||g/h/m^2||Standard Deviation|Mean
2547602|NCT02906566|Primary|Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Older Group, Retinol Versus Placebo)|Differences in transcript levels are reported as the number that were upregulated or downregulated in the participant's retinol-treated arm versus their placebo-treated arm.|Week 12|"Participants in the Young Group Ages 18-25 attended a single study visit at week 1 to provide tissue samples for comparison purposes, and are not included in this analysis."|||genes|genes||Number
2547603|NCT02906358|Secondary|Tampa Scale for Kinesiophobia (TSK)|This is a 11-item questionnaire, where individuals score items on a scale of 1 to 4 (1=strongly disagree, 4=strongly agree) to measures fear of completing physical activities. The scores are totaled for all items, to give a possible score of 44, which would indicate a greater fear of injuring oneself. A lower score would indicate less fear of injury to oneself.|Change from Baseline TSK at 6 months|We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.|||units on a scale||Standard Deviation|Mean
2547604|NCT02906358|Secondary|Patient Health Questionnaire -9 (PHQ-9)|The PHQ-9 is a brief, self-administered questionnaire that assesses somatic symptom severity. Participants rate the severity of 15 somatic symptoms as 0 (not bothered at all), 1 (bothered a little) or 2 (bothered a lot). The scores are totaled, with a possible total of 30, which would mean the most severe somatic symptoms, and 0 meaning the least somatic symptoms.|Change from Baseline PHQ-9 at 6 months|We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.|||units on a scale||Standard Deviation|Mean
2547605|NCT02906358|Secondary|Medical Outcomes Study 12-Item Short Form Mental Component Summary (SF-12 MCS)|The 12-item Short Form Health Survey created for Medical Outcomes Study measures mental summary scores through a brief survey with limited respondent burden while retaining precision. Mental Health Composite Scores are computed using the scores of 12 questions and range from 0 to 100, where 0 indicates the lowest level of mental health, and 100 indicates the highest level of mental health.|Change from baseline SF-12 MCS at 6 months|We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.|||units on a scale||Standard Deviation|Mean
2547606|NCT02906358|Secondary|Medical Outcomes Study 12-Item Short Form Physical Component Summary (SF-12 PCS)|The 12-item Short Form Health Survey created for Medical Outcomes Study measures physical summary scores through a brief survey with limited respondent burden while retaining precision. Physical Health Composite Scores are computed using the scores of 12 questions and range from 0 to 100, where 0 indicates the lowest level of health, and 100 indicates the highest level of health.|Change from Baseline SF-12 PCS at 6 months|We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.|||units on a scale||Standard Deviation|Mean
2547607|NCT02906358|Secondary|Borg Perceived Effort (Borg)|"Completed in conjunction with the 6-minute walk, this measures intensity and perceived effort after the test using a 0-10 Likert-type scale. Anchor words for the effort scales are no effort and most intense effort imaginable."|Change from Baseline perceived effort at 6 months|We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.|||units on a scale||Standard Deviation|Mean
2547608|NCT02906358|Secondary|6-minute Distance Walk (6MW)|For this test, participants walk as far as they can for six minutes, and the total distance in feet is measured with a surveyor's wheel pushed by a research assistant walking behind the subject. Participants can pause or stop as necessary.|Change from Baseline 6-minute distance walk at 6 months|We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.|||feet||Standard Deviation|Mean
2547609|NCT02906358|Secondary|The Brief Pain Inventory (BPI): Interference|The BPI is brief and uses simple 0-10 rating scales to measure the degree to which pain interferes with common dimensions of feeling and function, where zero is does not interfere and ten is completely interferes.|Change from Baseline BPI at 3 and 6 months|We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.|||units on a scale||Standard Deviation|Mean
2547610|NCT02906358|Secondary|The Brief Pain Inventory (BPI): Severity|The BPI is brief and uses simple 0-10 rating scales to measure pain intensity, where zero is no pain and ten is most intense pain imaginable.|Change from Baseline BPI at 3 and 6 months|We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.|||units on a scale||Standard Deviation|Mean
2547611|NCT02906358|Secondary|Symbol-Digit Modalities Test (SDMT)|Participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes (written and oral versions) with the correct digit assigned to a particular symbol. Total correct responses within 90 seconds were measured. The score of the test is the number of correct substitutions completed within the time limit, with a maximum score of 110. A score under 33 is generally considered to be a clear indicator of the existence of some type of cognitive disorder. The higher the score, the better the cognitive function.|Change from Baseline SDMT at 3 and 6 months|We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.|||units on a scale||Standard Deviation|Mean
2547612|NCT02906358|Secondary|Patient Specific Functional Scale (PSFS)|This is a brief, one-page document that prompts subjects to identify limitations to three activities, rank the importance of these activities, and track progress over time. The activities are scored on a scale of 0 to 10, where 0 indicates that the subject is unable to perform the activity and 10 indicates ability to perform the activity at the same level as before the injury or problem. The total summed score is divided by the number of activities, where a lower score would indicate less ability to perform the task, and the higher score would indicate easier performance of the task.|Change from Baseline PSFS at 3 and 6 months|We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.|||units on a scale||Standard Deviation|Mean
2547613|NCT02906358|Secondary|50-foot Speed Walk (50FtSW)|This test requires participants to walk along a 25-foot walkway turn around and return to the starting point. They are instructed to safely walk as fast as they can and the time taken to complete the test is recorded in seconds.|Change from Baseline 50-foot speed walk at 3 and 6 months|We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.|||seconds||Standard Deviation|Mean
2547614|NCT02906358|Primary|Five Times Sit-to-stand (5XSTS)|Participants are instructed to sit and stand up five times as fast as they can from a standard armless chair while the researcher times how many seconds it takes them to complete the task. After a brief rest, they repeat the test a second time and the average of two tests is calculated.|Change from Baseline sit-to-stand at 3 and 6 months|We report a completers analysis of unadjusted change in outcome measures in community and clinic arms at 3 months (for selected measures) and 6 months (for all measures), that include only completers in the participant flowchart (Community arm=36, Clinic arm 3 months=33, 6 months=31). Completers may differ by outcome if data was missing.|||seconds||Standard Deviation|Mean
2547615|NCT02905825|Secondary|Percentage of Agreement|Percentage of agreement between stool test reference standard and breath bags from urea breath test in assessing presence or absence of Helicobacter pylori infection|1 week||||percentage of pos. or neg. agreeement||95% Confidence Interval|Number
2547616|NCT02905825|Secondary|Percentage of Agreement|Percentage of agreement between stool test reference standard and continuous urea breath test in assessing presence or absence of Helicobacter pylori infection|1 week|Although 42 subjects completed the protocol, there was a device malfunction in this arm, therefore only 41 performed the continuous test.|||percentage of pos. or neg. agreeement||95% Confidence Interval|Number
2547617|NCT02905825|Primary|Number of Participants With Reported Adverse Events|Number of participants with reported adverse events after performing urea breath test|24 hours||||Participants|||Count of Participants
2547618|NCT02905331|Secondary|Percentage of Participants Who Achieved PASI 100 Responses, PASI 90 Responses, PASI 75 Responses, and PASI 50 Responses|PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that can range from 0 (no psoriasis) to 72.Participants with >=50%, >= 75%, >=90% and >= 100% improvement in PASI from baseline were considered PASI 50, 75, 90 and PASI 100 responders, respectively. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16.|Week 4, 8, 12, 16, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval)|FAS included all randomized participants who received at least 1 injection of study drug. Here, n (number analyzed) signifies number of participants who were analyzed at specific timepoint, for each arm, respectively. Non-responder imputation was used to impute missing data.|||Percentage of participants|||Number
2547619|NCT02905331|Secondary|Percentage of Participants Who Achieved an IGA Score of Cleared (0), Cleared (0) or Minimal (1) and Mild or Better (<=2) Through Week 40|The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders while those achieved an IGA score of cleared (0), minimal (1), or mild (2) were considered IGA mild or better responders. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16.|Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended q8w dosing interval)|FAS included all randomized participants who received at least 1 injection of study drug. Here, n (number analyzed) signifies number of participants who were analyzed at specific timepoint, for each arm, respectively. Non-responder imputation was used to impute missing data.|||Percentage of participants|||Number
2547620|NCT02905331|Secondary|Percent Improvement From Baseline in PASI Score Through Week 40|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received. From week 20, participants in placebo group, only included participants who crossed over to receive guselkumab at week 16.|Baseline, Week 4, 8, 12, 20, 24, 28, 32, and Week 40 (4 weeks beyond the recommended every 8 weeks [q8w] dosing interval)|FAS included all randomized participants who received at least 1 injection of study drug. Here, n (number analyzed) signifies number of participants who were analyzed at specific timepoint, for each arm, respectively. Imputation was applied only for participants who met treatment failure and their missing values were counted as zero.|||Percent improvement||Standard Deviation|Mean
2547621|NCT02905331|Secondary|Percent Improvement From Baseline in PASI Score at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.|Baseline and Week 16|FAS included all randomized participants who received at least 1 injection of study drug. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Imputation was applied only for participants who met treatment failure and their missing values were counted as zero.|||Percent improvement||Standard Deviation|Mean
2547629|NCT02905266|Secondary|Geometric Mean Trough Concentration of Ipilimumab|Nivolumab and ipilimumab concentrations are summarized at the end of infusion (EOI) and prior to the next dose (predose)|From Cycle 2, Day 1 to Cycle 4, Day 1|All treated participants|||micrograms per milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2547622|NCT02905331|Secondary|Percentage of Participants Who Achieve a PASI 50 Response and a PASI 75 Response at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with >=50% and >= 75% improvement in PASI from baseline were considered PASI 50 and PASI 75 responders respectively. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.|Week 16|FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.|||Percentage of participants|||Number
2547623|NCT02905331|Secondary|Percentage of Participants Who Achieved an IGA Score of Mild or Better (Less Than or Equal to [<=] 2) at Week 16|The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0), minimal (1), or mild (2) were considered IGA mild or better responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.|Week 16|FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.|||Percentage of participants|||Number
2547624|NCT02905331|Secondary|Percentage of Participants Who Achieve a PASI 100 Response at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. Participants with 100% improvement in PASI from baseline (PASI score=0) were considered PASI 100 responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.|Week 16|FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.|||Percentage of participants|||Number
2547625|NCT02905331|Secondary|Percentage of Participants Who Achieve an IGA Score of Cleared (0) at Week 16|The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) were considered IGA cleared responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.|Week 16|FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.|||Percentage of participants|||Number
2547626|NCT02905331|Primary|Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 90 Response at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent (%) to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure.|Week 16|FAS included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.|||Percentage of participants|||Number
2547627|NCT02905331|Primary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16|The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved an IGA score of cleared (0) or minimal (1) were considered IGA cleared or minimal responders. Non-responder imputation (counted as non-responders) was applied for participants who met treatment failure rules, as well as for remaining missing data after treatment failure. Participants who discontinued study drug due to lack of efficacy, an adverse event (AE) of worsening of psoriasis, or who started a protocol-prohibited medication/therapy during study that could improve psoriasis were considered as treatment failures for the study.|Week 16|Full analysis set (FAS) included all randomized participants who received at least 1 injection of study drug. Participants were analyzed according to the assigned treatment to which they were randomized, regardless of the treatment they actually received.|||Percentage of participants|||Number
2547628|NCT02905266|Secondary|Geometric Mean Trough Concentration of Nivolumab|Nivolumab and ipilimumab concentrations are summarized at the end of infusion (EOI) and prior to the next dose (predose)|From Cycle 2, Day 1 to Cycle 4, Day 1|All treated participants|||micrograms per milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2560605|NCT02662569|Secondary|Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)||Weeks 10 and 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2547630|NCT02905266|Secondary|Geometric Mean Concentration of Nivolumab at End of Infusion|Nivolumab and ipilimumab concentrations are summarized at the end of infusion (EOI) and prior to the next dose (predose)|assessed from Cycle 1, Day 1 to Cycle 4, Day 1, Cycle 1 Day 1, Cycle 2 Day 1, and Cycle 4 Day 1 reported|All treated participants|||micrograms per milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2547631|NCT02905266|Secondary|Geometric Mean Concentration of Ipilimumab at End of Infusion|PK comparisons will be summarized using descriptive summary statistics to compare nivolumab and ipilimumab predose and end of infusion (EOI) concentrations administered as FRC to that of sequentially administered nivolumab and ipilimumab. End of infusion and trough (predose) concentration levels of nivolumab and ipilimumab will be summarized by treatment arm and study day|assessed from Cycle 1, Day 1 to Cycle 4, Day 1, Cycle 1 Day 1, Cycle 2 Day 1, and Cycle 4 Day 1 reported|All treated participants|||micrograms per milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2547632|NCT02905266|Secondary|Percentage of Participants Affected by Drug-related Grade 3 - 5 AEs Defined Using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 Criteria|The drug-related Grade 3 - 5 AE rate is defined as number of subjects who experienced at least 1 AE of Grade 3 or higher, judged to be related to study drug by the investigator, and with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment, divided by number of treated subjects.|From initial dose of study treatment and within 30 days of the last dose of study treatment (assessed up to December 2017, approximately 13 months)|All treated participants|||Percentage||95% Confidence Interval|Number
2547633|NCT02905266|Secondary|Percentage of Participants Affected by All Causality Grade 3 - 5 AEs Defined Using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 Criteria|The all causality Grade 3 - 5 AE rate is defined as number of subjects who experienced at least 1 AE of Grade 3 or higher with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment, divided by number of treated subjects.|From initial dose of study treatment and within 30 days of the last dose of study treatment (assessed up to December 2017, approximately 13 months)|All treated participants|||Percentage||95% Confidence Interval|Number
2547634|NCT02905266|Secondary|Percentage of Participants Affected by AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ and the Select AE Hypersensitivity/ Infusion Reaction Category|The select AEs consist of a list of preferred terms defined by the Sponsor and represent AEs with a potential immune-mediated etiology. At the time of this writing the following 4 MedDRA preferred terms are included in the hypersensitivity/infusion reaction select AE category: Anaphylactic Reaction, Anaphylactic Shock, Hypersensitivity, and Infusion Related Reaction. Changes may be made to this list with each new version of MedDRA prior to database lock. The list that is the most current at the time of analysis will be used. The incidence rate of hypersensitivity/infusion reaction select AEs will be defined similarly to the primary endpoint except that the event rate will be based on terms from the hypersensitivity/infusion reaction select AE category rather than the MedDRA Anaphylactic Reaction broad scope SMQ.|Within 2 days of dose in Part 1 period (assessed up to December 2017, approximately 13 months)|All treated participants|||Percentage||95% Confidence Interval|Number
2547635|NCT02905266|Primary|Percentage of Participants Affected by Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ)|The Anaphylactic Reaction SMQ includes any acute systemic reaction characterized by a large list of terms, pruritus, urticaria, flushing, hypotension, respiratory distress, and vascular insufficiency. It also includes other signs and symptoms such as asthma, choking sensation, coughing, sneezing, and difficulty breathing due to laryngeal spasm and/or bronchospasm. Less frequent clinical presentations are also captured and include hyperventilation, sensation of foreign body, and ocular edema.The number of participants affected by AEs in Broad Scope MedDRA anaphylactic Reaction SMQ was divided by the number of treated participants and expressed as a percentage|Within 2 days of dose in part 1 period (assessed up to December 2017, approximately 13 months)|All treated participants|||Percentage||95% Confidence Interval|Number
2547636|NCT02905149|Secondary|Presence of Opioid Related Complications|presence of nausea/vomit or apnea or urinary retention or ileus is assessed. It is a dicothomic composite (yes or no).|First 24 hours after surgery||||Participants|||Count of Participants
2547637|NCT02905149|Secondary|Time to First Opioid Administration on the Ward|Time to first opioid administration on the ward|First 24 hours after surgery||||hours||95% Confidence Interval|Mean
2547638|NCT02905149|Secondary|Pain at Rest and Coughing|Pain at rest and coughing at 24h postoperative (Visual analogue scale 0-10 with 0 meaning no pain and 10 meaning the worst imaginable pain). High score mean worse outcomes|First 24 hours after surgery||||units on a scale||Inter-Quartile Range|Median
2547639|NCT02905149|Primary|Total Opioid Usage|Total opioid usage in the first 24 hours (intra and postoperative) (in morphine milligrmas, fentanyl/morphine conversion = 10 mcgs/1mg). Opioid used will be fentanyl and morphine. Fentanyl will be converted in morphine milligrams equivlents to caluclate the total first 24H dose.|First 24 hours after surgery|2 participants were lost to follow up because of malfunctioning of the electronic device administering the potoperative opioid|||milligrams||95% Confidence Interval|Median
2547640|NCT02904915|Primary|Pain Score as Assessed by a Visual Analogue Scale|"The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD).~The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine)."|about 30 seconds after insertion of the IUD (IUD inserted about 4 to 5 minutes after insertion of tenaculum)||||units on a scale||Standard Deviation|Mean
2547661|NCT02903394|Secondary|Number of Patients With Automated Classification of Cervical Epithelium|The number of patients for which an interferometric tissue classification was made using optical mLCI data|day 1|Patients from whom epithelial interferometric data were successfully captured and for whom a corresponding colposcope image could be registered. No pilot study patients were included as no colposcopic examination was conducted in the pilot phase.|||patients|||Number
2547641|NCT02904915|Primary|Pain Score as Assessed by a Visual Analogue Scale|"The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD).~The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine)."|about 30 seconds after insertion of the tenaculum (tenaculum inserted about 2 to 3 minutes after insertion of speculum)||||units on a scale||Standard Deviation|Mean
2547642|NCT02904915|Primary|Pain Score as Assessed by a Visual Analogue Scale (VAS)|"The order of overall events are: insertion of speculum, assessment of pain via a visual analogue scale (VAS) (about 30 seconds after insertion of the speculum), injection of 2cc 1% lidocaine at the tenaculum site of the cervix, placement of tenaculum (about 2-3 minutes after insertion of speculum), assessment of pain via VAS (about 30 seconds after insertion of the tenaculum), injection of 3cc 1% lidocaine at the 4 and 8 o'clock position of the cervix, insert IUD (about 4-5 minutes after insertion of tenaculum), and assessment of pain via VAS (about 30 seconds after insertion of the IUD).~The Faces pain VAS was used, which ranges from 0 (very happy, no hurt) to 10 (hurts as much as you can imagine)."|baseline (about 30 seconds after insertion of the speculum)||||units on a scale||Standard Deviation|Mean
2547643|NCT02904902|Secondary|Change From Baseline to Week 12 in Modified Sartorius Scale Score|The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other). For each area, points are awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated buy normal skin (yes-0 point; no-6 points). The total Sartorius Scale score is the sum of the 12 regional scores. Scale scores range from 0 to infinite, with larger scores representing higher severity of HS.|Baseline (last non-missing value on or before the date of first dose of study drug), Week 2, Week 4, Week 8, Week 12|Full Analysis Set: all participants from sites that complied with Good Clinical Practice and received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2547644|NCT02904902|Secondary|Percentage of Participants Achieving at Least 30% Reduction and at Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) - At Worst at Week 2 Among Participants With Baseline Numeric Rating Scale (NRS) >=3|"The participant's Global Assessment of Skin Pain NRS was used to assess the worst skin pain due to HS. Scores range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours."|Week 0 (Baseline), Week 2|Full Analysis Set: all participants from sites that complied with Good Clinical Practice and received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment. Participants with Baseline NRS - at worst >=3.|||percentage of participants||95% Confidence Interval|Number
2547645|NCT02904902|Secondary|Percentage of Participants Achieving AN Count of 0, 1, or 2 at Week 12|The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12.|Week 12|Full Analysis Set: all participants from sites that complied with Good Clinical Practice and received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment. Non responder imputation.|||percentage of participants||95% Confidence Interval|Number
2547646|NCT02904902|Primary|Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12|HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.|Week 12|Full Analysis Set: all participants from sites that complied with Good Clinical Practice and received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment. Non responder imputation.|||percentage of participants||95% Confidence Interval|Number
2547647|NCT02904356|Primary|Change in Functional Magnetic Resonance Imaging (fMRI) BOLD Response|Change in blood-oxygen-level dependent (BOLD) correlates corresponding to task engagement before and after rTMS will be assessed.|Up to 1 month|PI left institution, no data was collected and analyzed in the specified manner.||||||
2547648|NCT02904096|Secondary|Number of Subjects With Any Improvement on GAIS Following 3 Months After Retreatment at Months 9, 15 and 21|The GAIS is a 7-point scale. The 7-point scale are as follow: +3 (very much improved), +2 (much improve), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), and -3 (very much worse).|Months 9, 15, and 21|Data were not collected and analyzed for this outcome measure due to change in planned analysis.||||||
2547649|NCT02904096|Secondary|Number of Subjects With Any Improvement on Global Aesthetic Improvement Scale (GAIS) From Baseline in Both Hands at Month 3 After Initial Treatment|The GAIS is a 7-point scale. The 7-point scale are as follow: +3 (very much improved), +2 (much improve), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), and -3 (very much worse).|Month 3|The SES was the subset of all subjects who were exposed to the study device at enrollment.|||Participants|||Count of Participants
2547650|NCT02904096|Secondary|Number of Subjects With MHGS >=1-point Improvement Following 3 Months After Retreatment at Months 9, 15 and 21|The MHGS was used to measure clinical effectiveness of the Radiesse hand treatments by a masked evaluator performing live, dorsal hand assessments. The MHGS was an ordinal scale; therefore, ratings were made at a single, live rating at a specific study time point. A measure of successful or improved treatment effect was demonstrated by a decrease in MHGS score. MHGS had 5 categories, where: 0 (no loss of fatty tissue); 1 (mild loss of fatty tissue; slight visibility of veins); 2 (moderate loss of fatty tissue; mild visibility of veins and tendons); 3 (severe loss of fatty tissue; moderate visibility of veins and tendons); 4(very severe loss of fatty tissue; marked visibility of veins and tendons).|Months 9, 15, and 21|Data were not collected and analyzed for this outcome measure due to change in planned analysis.||||||
2547662|NCT02903394|Primary|Number of Patients With Interferometric Data Acquired From Cervical Epithelium|measured by: ability to receive interferometric data from at least one portion of the cervical epithelium|day 1||||patients|||Number
2547651|NCT02904096|Secondary|Number of Subjects With MHGS Scores Greater Than or Equal (>=) to 1-point Improvement From Baseline in Both Hands at Month 3 After Initial Treatment|The MHGS was used to measure clinical effectiveness of the Radiesse hand treatments by a masked evaluator performing live, dorsal hand assessments. The MHGS was an ordinal scale; therefore, ratings were made at a single, live rating at a specific study time point. A measure of successful or improved treatment effect was demonstrated by a decrease in MHGS score. MHGS had 5 categories, where: 0 (no loss of fatty tissue); 1 (mild loss of fatty tissue; slight visibility of veins); 2 (moderate loss of fatty tissue; mild visibility of veins and tendons); 3 (severe loss of fatty tissue; moderate visibility of veins and tendons); 4(very severe loss of fatty tissue; marked visibility of veins and tendons).|Month 3|The SES was the subset of all subjects who were exposed to the study device at enrollment.|||Participants|||Count of Participants
2547652|NCT02904096|Secondary|Change From Baseline in Grip Strength, Tip Pinch Strength, Key Pinch Strength, and Palmar Strength in Each Hand at Month 24|Hand strength was assessed in two ways grip and pinch strengths. Grip strength was assessed using a standard, adjustable-handle Jamar hydraulic hand dynamometer. Pinch strength was assessed in three different ways such as tip (two-point) pinch, key (lateral) pinch, and palmar (three-jaw chuck) pinch using the Jamar hydraulic pinch gauge. Lower values (pounds) in hand grip and pinch strength are associated with deterioration in function.|Baseline, Month 24|The SES was the subset of all subjects who were exposed to the study device at enrollment. The SES were evaluable for this measure at a given time period and were included in the assessment.|||pounds||Standard Deviation|Mean
2547653|NCT02904096|Secondary|Change From Baseline in Sensation to Filament Size Between Metacarpals in Each Hand at Month 24|Sensation in the dorsum of each hand was conducted using a Semmes-Weinstein monofilament touch test. This was assessed using an index finger touch protocol, where by study subject was asked to report when a 2 to 3 centimeter (cm) light touch is felt at 3 different areas of the dorsum of each hand. Sensation results were coded for analysis such as response to 2.83 filament = 1, response to 3.61 filament = 2, response to 4.31 filament = 3, response to 4.56 filament = 4, response to 6.65 filament = 5, and no response to either filament = 6. For sensation testing a value of 1 (response to 2.83 filament) is considered normal while a value of 2 (response to 3.61) would show diminished light touch. Score ranges from 1 to 6. A higher value in sensation measurements is associated with a deterioration in hand function.|Baseline, Month 24|The SES was the subset of all subjects who were exposed to the study device at enrollment. The SES were evaluable for this measure at a given time period and were included in the assessment.|||scores on a scale||Standard Deviation|Mean
2547654|NCT02904096|Secondary|Change From Baseline in Functional Dexterity in Each Hand at Month 24|The functional dexterity test (FDT) assessed the fine motor skills (dexterity) that means it assessed the subject's ability to use the hand for daily tasks requiring the 3-jaw chunk prehensions that is buttoning, tying shoelaces, screwing a nut and bolt, and lacing yarn using a 16-hole peg board. Functional Dexterity was measured by noting the time in seconds on stopwatch for a hand to invert pegs on a 16-hole pegboard and this test assessed the ability to use hand for daily tasks. Longer times to complete the functional dexterity test means deterioration in hand function.|Baseline, Month 24|The SES was the subset of all subjects who were exposed to the study device at enrollment. The SES were evaluable for this measure at a given time period and were included in the assessment.|||seconds||Standard Deviation|Mean
2547655|NCT02904096|Secondary|Change From Baseline in Range of Motion (ROM) Flexion and Extension (Angle) for Metacarpophalangeal Joints in Each Hand at Month 24|The ROM was assessed using a Jamar finger goniometer. This test passively and actively measured the angle of motion of all five metacarpophalangeal joints in each hand right and left by determining the flexion and extension angles. The flexion determined how far each finger could be flexed at the metacarpophalangeal joint toward the palm. The extension determined how each finger could be extended at the metacarpophalangeal joint away from the palm. Degree scale ranges from 0 to 180 degree. Lower values in flexion angle and extension angle means more deterioration in hand function.|Baseline, Month 24|The SES was the subset of all subjects who were exposed to the study device at enrollment. The SES were evaluable for this measure at a given time period and were included in the assessment.|||degrees||Standard Deviation|Mean
2547656|NCT02904096|Secondary|Proportion of Subjects With Device-and/Injection-related Severe TEAEs in the Grade 4 Hands Group Versus the Grade 2-3 Hands Group at Month 24|Proportion refers to percentage of subjects with device-and/injection-related severe TEAEs.|Month 24|The SES was the subset of all subjects who were exposed to the study device at enrollment.|||percentage of subjects|||Number
2547657|NCT02904096|Primary|Proportion of Subjects With Device-and/or Injection-related Severe Treatment-emergent Adverse Events (TEAEs) in the Grade 4 Hands Group Versus the Grade 2-3 Hands Group at Month 6|Proportion refers to percentage of subjects with device-and/or injection-related severe TEAEs.|Month 6|The SES was the subset of all subjects who were exposed to the study device at enrollment.|||percentage of subjects|||Number
2547658|NCT02903836|Secondary|Clinical Response in the Micro-ITT Population|Clinical response (response, non-response, or indeterminate) at Day 4 was also tested in the micro-ITT population as a secondary efficacy endpoint. Clinical response was determined programmatically using the investigator's assessment of CABP symptoms entered into the eCRF. The severity of the subject CABP symptoms of dyspnea (shortness of breath), cough, production of purulent sputum, and pleuritic chest pain were evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Symptom Severity Guidance|Day 4 from start of drug administration|The micro-ITT population included all ITT subjects who had at least one baseline Gram-positive or atypical bacterial pathogen known to cause CABP.|||Participants|||Count of Participants
2547659|NCT02903836|Primary|Clinical Response in the ITT Population|The primary efficacy endpoint was clinical response (response, non-response, or indeterminate) at Day 4, tested in the ITT population. Clinical response was determined programmatically using the investigator's assessment of CABP symptoms entered into the eCRF. The severity of the subject CABP symptoms of dyspnea (shortness of breath), cough, production of purulent sputum, and pleuritic chest pain were evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Symptom Severity Guidance|Day 4 from start of drug administration||||Participants|||Count of Participants
2547660|NCT02903394|Secondary|Number and Frequency of Adverse Events|Number of adverse events experienced by patients during the mLCI study.|day 1||||events|||Number
2547663|NCT02903238|Secondary|Overall Brain Neocortical Gray Matter Volume||2 weeks|Data were not collected and the Outcome will never be analyzed||||||
2547664|NCT02903238|Secondary|WOMAC Pain Index|Osteoarthritis (OA) specific pain and quality of life index (the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC). The WOMAC score is from 0 to 96 where 0 represent no pain and quality of life impairment due to OA and 96 represent the worst pain and quality of life impairment due to OA. The outcome is reported as the percent change from baseline to end of treatment (2 weeks).|2 weeks||||Percent Change in WOMAC score||Standard Deviation|Mean
2547665|NCT02903238|Primary|Brain Regional Gray Matter Density|"Gray matter density (GMD) of the prefrontal cortex region identified as placebo biomarker. Placebo responders/non-responders were identified based on the VAS score. A minimum of 20% decrease in VAS score was needed to be qualified as responders.~GMD is a value between 0 and 1 representing the intensity of every brain voxels. The GMD of the prefrontal cortex region represent the average GMD of every voxels in this region."|2 weeks||||Gray Matter Density: 0 to 1||Standard Deviation|Mean
2547666|NCT02903030|Secondary|Change in The Parenting Stress Index Short Form (PSI)|The PSI is used to evaluate the degree of stress in the parent-child relationship. The Short Form has 36 items from the full length PSI, rated on a 5-point scale from 1 = strongly disagree, to 5 = strongly agree. It is completed in 10-15 minutes. The PSI may be used for parents of children up to 12 years. It yields a Total Score and three domain scores. This will detect effect on parental stress and QOL. Higher scores (ranging from 0-180) are worse for PSI, hence a negative estimate means more improvement with the probiotics compared to control.|Baseline and Week 8 of Both the First and Second Intervention||||Units on a scale||Standard Deviation|Mean
2547667|NCT02903030|Secondary|Children's Sleep Habits Questionnaire (CSHQ) at Week 8|It includes 33 items rated retrospectively over the previous week by parents yielding a total score and eight subscales. Eight subscales include: (1) bedtime resistance (2) sleep onset latency, (3) sleep duration, (4) anxiety around sleep, (5) night awakenings, (6) sleep disordered breathing, (7) parasomnias and (8) morning waking/daytime sleepiness.Total score (summed) range of 0-99. A higher score is a better outcome for this measure.|Week 8 of Both the First and Second Intervention||||Units on a scale||Standard Deviation|Mean
2547668|NCT02903030|Secondary|Change in Social Responsiveness Scale (SRS) From Baseline at Week 8|This 65-item rating scale measures the severity of autism spectrum symptoms as they occur in natural social settings. The SRS provides a clear picture of a child's social impairments, assessing social awareness, social information processing, capacity for reciprocal social communication, social anxiety/avoidance, and autistic preoccupations and traits. It is appropriate for use with children from 4 to 18 years of age and will detect changes in core ASD symptoms. A higher score in this scale represents worse symptoms with raw scores summed and generated t-scores ranging from 0-110.|Baseline and Week 8 of Both the First and Second Intervention||||Units on a scale||Standard Deviation|Mean
2547669|NCT02903030|Secondary|Change in The Aberrant Behavior Checklist (ABC) From Baseline at Week 8|"The ABC is a 58-item parent rating on a 0-3 scale with five subscales:~Irritability (includes agitation, aggression, and self-injury, 15 items) with range of scores from 0-45~Social Withdrawal (16 items) with range of scores from 0-48~Stereotypies (7 items) with range of scores from 0-21~Hyperactivity (16 items) with range of scores from 0-48~Inappropriate Speech (4 items) with range of scores from 0-12.~Higher scores are worse for the ABC subscale, hence a negative estimate means more improvement with the probiotics compared to control."|Baseline and Week 8 of Both the First and Second Intervention||||Units on a scale||Standard Deviation|Mean
2547670|NCT02903030|Secondary|Change in Parent Anxiety Checklist--ASD From Baseline at Week 8|A 25-item single-factor scale measure of emotional stability/anxiety. Higher scores are worse for PRAS-ASD subscale, hence a negative estimate means more improvement with the probiotics compared to control. Scores range from 0-75.|Baseline and Week 8 of Both the First and Second Intervention||||Units on a scale||Standard Deviation|Mean
2547671|NCT02903030|Secondary|Change in Target Symptom Rating From Baseline at Week 8|Parents are asked to name the 2 problems of most concern to them at baseline; a clinician helps the parent quantify and describe the problem (frequency, duration, severity, interference with daily life) at baseline. At subsequent visits the clinician reminds the parent of the previous description and helps them again quantify/describe the current state. A panel of blind clinicians reviews the descriptions and rates each on a 9-point scale relative to baseline, from remission (0) to disastrously worse (9), with 5=no change. These ratings are averaged, capturing the issues of most concern to parents across families. For purposes of this study, one of the 2 problems will be required to pertain to GI function, and will be analyzed separately as well as being averaged into the overall symptom rating.|Baseline and Week 8 of Both the First and Second Intervention||||Units on a scale||Standard Deviation|Mean
2547672|NCT02903030|Primary|Change in Gastrointestinal (GI) Module of the Pediatric Quality of Life Inventory (PedsQL) at From Baseline at Week 8|A 74-item survey with 14 scales. Report forms for specific age ranges assess the parent's perception of the child's GI function and/or symptoms during the last month on a 5-point scale from 0 (never a problem) to 4 (almost always a problem). Items are reverse-scored and transformed to a 0-100 scale so lower scores reflect worse GI dysfunction. Response choices are in Likert-scale format ranging from 0 to 4 (0=Never, 1=Almost Never, 2=Sometimes, 3=Often, 4=Almost Always).|Baseline and Week 8 of Both the First and Second Intervention||||Units on a scale||Standard Deviation|Mean
2547673|NCT02902965|Secondary|Safety and Tolerability of Ibrutinib in Combination With Bortezomib and Dexamethasone as Measured by the Number of Participants With Adverse Events.|Safety and tolerability of ibrutinib in combination with bortezomib and dexamethasone as measured by the frequency and type of adverse events graded using the NCI CTCAE v 4.03. Frequency and Type of Adverse Events are reported in the Adverse Events module|From first dose of Ibrutinib to within 30 days of last dose for each participant or until study closure. This is the median treatment duration for Ibrutinib of 5.7 months (range: 0.1 - 23.7 months) +30 days (Adverse Events collection period).|Safety population|||Participants|||Count of Participants
2547674|NCT02902965|Secondary|Time to Progression (TTP)|Time from date of first dose of study treatment to the date of first documented evidence of PD or date of censoring for the participants not progressed. The censoring date is the last adequate tumor assessment date.|The median time on study was 19.6 months (range: 0.16+, 24.64).||||Months||95% Confidence Interval|Median
2547675|NCT02902965|Secondary|Overall Survival (OS) at 24 Months|As the median overall survival has not been reached, the data for the landmark analysis at 24 months are provided.|The median time on study was 19.6 months (0.16+, 24.64), with the 24 month Overall Survival (OS) rate presented based on Kaplan-Meier estimates.||||percentage of participants||95% Confidence Interval|Number
2547676|NCT02902965|Secondary|Duration of Response (DOR)|The time interval between the date of initial documentation of a response (PR or better) and the date of first documented evidence of PD, death, or date of censoring for the participants not progressed/died. The censoring date is the last adequate tumor assessment date.|The median time on study was 19.6 months (range: 0.16+, 24.64).||||Months||95% Confidence Interval|Median
2547677|NCT02902965|Secondary|Progression Free Survival (PFS) at Landmark Points - 20 Months|PFS at landmark points are the percentage of participants without progression (i.e., KM estimates) at the landmark time endpoints.|The median time on study was 19.6 months (range: 0.16+, 24.64), with the 20 month Progression-Free Survival (PFS) rate presented based on Kaplan-Meier estimates.||||percentage of participants||95% Confidence Interval|Number
2547678|NCT02902965|Secondary|Overall Response Rate (ORR)|Overall Response Rate is the percentage of participants who achieve a PR or better over the course of the study but prior to initiation of subsequent anti-cancer therapy|The median time on study was 19.6 months (range: 0.16+, 24.64). Participants were evaluated for Overall Response (OR) during the entire time on the study.||||percentage of participants||95% Confidence Interval|Number
2547679|NCT02902965|Primary|Median Progression-Free Survival (PFS)|The primary efficacy endpoint of this study is mPFS. Progression free survival is defined as the time from the date of first dose of study treatment to confirmed disease progression or death from any cause, whichever occurs first.|The median time on study was 19.6 months (range: 0.16+, 24.64). Participants were evaluated for Progression-Free Survival (PFS) during their entire time on the study.|All participant received: see description on Arm/Group description. Following implementation of Amendment 4, dexamethasone administration was reduced to Days 1, 4, 8 and 11 during each 21-day cycle (Cycles 1-8) and on Days 1, 8, 22 and 29 on each 42-day cycle (Cycles 9-12) and unchanged thereafter.|||Months||95% Confidence Interval|Median
2547680|NCT02902913|Secondary|Activated Platelet Oxylipin Production|"Oxylipins derived from cyclooxygenase, lipoxygenase, and cytochrome P450 dependent metabolism of AA were quantified using liquid chromatography with tandem mass spectrometry (LC-MS/MS) in 100 µL of PRP plasma activated with collagen or ADP as well as 100 µL of unactivated PRP plasma collected before and two hours after treatment with EVOO or ibuprofen.~Data were mean centered and reported as a % change from baseline."|Change from baseline 2 hours post intake|healthy adult males|||percentage of change from baseline|||Number
2547681|NCT02902913|Primary|Optical Platelet Aggregometry|Maximal platelet aggregation in minutes will be measured using optical platelet aggregometry|Change from baseline 2 hours post intake||||percentage of maximal aggregation||Standard Deviation|Mean
2547682|NCT02902809|Primary|Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities|The ECG assessments were performed using an ECG device prior to blood drawing, spirometry, investigational product administration and bronchodilator administration. ECG data and evaluation was planned to be performed by the site Investigator.|At Day -14 and Week 52.|The study was terminated due to discontinuation of tralokinumab asthma program. Study was reported in a synopsis format. Individual listings were evaluated for safety signal. No summary table was developed.||||||
2547683|NCT02902809|Primary|Number of Participants With Vital Signs Abnormalities|Vital signs that were planned to be assessed included parameters such as pulse, systolic blood pressure, diastolic blood pressure, respiration rate and body temperature.|From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).|The study was terminated due to discontinuation of tralokinumab asthma program. Study was reported in a synopsis format. Individual listings were evaluated for safety signal. No summary table was developed.||||||
2547684|NCT02902809|Primary|Number of Participants With Abnormal Physical Examinations|Physical examination included assessment of general appearance, skin, head and neck (including eyes, ears, nose, mouth and throat), lymph nodes, abdomen, musculoskeletal (including spine and extremities), cardiovascular, respiratory, and neurological systems. Criteria for abnormal physical findings were based on investigator's discretion.|From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).|The study was terminated due to discontinuation of tralokinumab asthma program. Study was reported in a synopsis format. Individual listings were evaluated for safety signal. Any new finding(s) or aggravated existing finding(s), judged as clinically significant by the Investigator, were reported as an AE.||||||
2547685|NCT02902809|Primary|Number of Participants With Clinical Laboratory Abnormalities|Blood and urine samples for determination of clinical chemistry, haematology and urinalysis parameters were taken at the times. Changes in haematology and clinical chemistry variables between baseline and each subsequent scheduled assessment were evaluated. Baseline is defined as the last available value measured prior to the first dose of study treatment. The change from baseline is defined as the treatment period value minus the baseline period value. Absolute values were compared to the relevant reference range and classified as low (below range), normal (within range or on limits) or high (above range). The AstraZeneca extended reference ranges were used for laboratory variables (where they exist). All values (absolute and change) falling outside the reference ranges were flagged. Urinalysis data were categorised as negative (0), trace or positive (+) at each time point.|From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).|No participants were analysed as the study was terminated due to discontinuation of tralokinumab asthma program. Study was reported in a synopsis format. Individual listings of clinical laboratory parameters were evaluated for safety signal.||||||
2547686|NCT02902809|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was development of an undesirable medical condition or deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to product. An undesirable medical condition can be symptoms, signs or the abnormal results of an investigation. In clinical studies, an AE can include an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment has been administered. A SAE was an AE occurred during any study phase that fulfils one or more of the following criteria: death; immediately life-threatening, in-patient or prolongation of existing hospitalization; persistent or significant disability/incapacity or substantial disruption of ability to conduct normal life functions; congenital abnormality or birth defect; important medical event that may jeopardise participant or may require medical intervention to prevent one of the outcomes listed above.|From Screening (Day -14) up to 14 weeks after end of treatment (Week 66).|The safety analysis set included all participants enrolled and who received at least 1 dose of investigational product irrespective of their protocol adherence and continued participation in the study.|||Participants|||Count of Participants
2547688|NCT02902172|Secondary|Change in the Mean Diastolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.|To determine if NSAIDS in the postpartum period raise blood pressure in women with a hypertensive disorder. The mean increase and standard deviation of each group (acetaminophen and NSAID/Ibupforen) was calculated when compairing diastolic blood pressures from the first postpartum day to the second postpartum day. Day 1 is the mean of diastolic blood pressures from 0 hours to 23 hours after delivery, and Day 2 is the mean of diastolic blood pressures from 24 hours to 47 hours after delivery.|2 days||||mmHg||Standard Deviation|Mean
2547689|NCT02902172|Primary|Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.|To determine if NSAIDS in the postpartum period raise blood pressure in women with a hypertensive disorder. The mean increase and standard deviation of each group (acetaminophen and NSAID/Ibupforen) was calculated when compairing systolic blood pressures from the first postpartum day to the second postpartum day. Day 1 is the mean of systolic blood pressures from 0 hours to 23 hours after delivery, and Day 2 is the mean of systolic blood pressures from 24 hours to 47 hours after delivery.|2 days|Mean difference day 1 compared to day 2 of systolic blood pressure|||mmHg||Standard Deviation|Mean
2547690|NCT02902146|Secondary|Hypoxemia|Hypoxemia is defined as a pulse oximetry value (SpO2) less than 90% at any point during intubation, or a drop of more than 10% from baseline if starting below 90%. The outcome of hypoxemia will be recorded beginning when the first attempt begins and ending one minute after inflation of the ETT cuff.|5 minutes|The patients not included in these numbers did not have a valid oximetry waveform during intubation.|||Participants|||Count of Participants
2547691|NCT02902146|Secondary|Esophageal Intubation|defined as passage of the ETT into the esophagus, with subsequent ventilation, and then removal. Clinically, esophageal intubation is identified by the absence of end-tidal carbon dioxide, abnormal physical exam, and hypoxia. This does not count passage of the ETT into the esophagus during the attempt if the ETT is removed during the attempt.|5 minutes||||Participants|||Count of Participants
2547692|NCT02902146|Secondary|Time to Intubation (First Attempt)|Time to intubation will be defined as the time elapsed between the beginning of the intubation attempt to inflation of the ETT cuff when the tube is in the trachea.|5 minutes||||seconds||Inter-Quartile Range|Median
2547693|NCT02902146|Secondary|First Pass Success Without Hypoxemia|"First pass success without hypoxemia. Hypoxemia is defined as a pulse oximetry value (SpO2) less than 90% at any point during intubation, or a drop of more than 10% from baseline if starting below 90%. The outcome of hypoxemia will be recorded beginning when the first attempt begins and ending one minute after inflation of the ETT cuff.~A patient will be considered to achieve this outcome if 1) they are intubated successfully on the first attempt, and 2) do not experience hypoxemia on the first attempt."|5 minutes|The patients not included in this number had no oximetry waveform available|||Participants|||Count of Participants
2547694|NCT02902146|Primary|Number of Participants With First Pass Success|"First pass success is defined as placement of the endotracheal tube (ETT) into the trachea on the first attempt. An attempt begins when the laryngoscope enters the mouth, and ends if either of the following occur:~the laryngoscope leaves the mouth, regardless of whether an attempt was made to pass the endotracheal tube or bougie.~if the operator cannot intubate the trachea with the first tube device (ETT or bougie), and switches to any other tube device, even if the laryngoscope blade remains in the mouth.~A patient will be considered to achieve the primary outcome if they are intubated successfully on the first attempt."|5 minutes||||Participants|||Count of Participants
2547695|NCT02902081|Primary|Positivity Ratings of Social Images|Using the International Affective Picture System (IAPS; Lang et al. 1999), participants viewed standardized positive, negative and neutral pictures from the IAPS. The negative and positive images were matched on degree of valence and arousal. An Evaluative Space Grid rating followed each picture to collect subjective reactions. Ratings are on a 9-pt scale. The range of the scale is from 1 to 9 (Min score 1, max score 9). The total score is reported. Higher numbers represent more positive valence or greater arousal. Drug treatment: within-subjects; every participant received all drug doses, counter-balanced.|End of study (time 0 and approximately 4 weeks later), week 4 reported.||||score on a scale||Standard Error|Mean
2547696|NCT02901951|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed included any untoward medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the entire study period (Day 0 to Day 30)|Analysis was performed on the TVC which included all subjects who received the challenge dose.|||Participants|||Count of Participants
2547697|NCT02901951|Secondary|Number of Subjects With Any Unsolicited AEs|An unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) follow-up period after the challenge dose|Analysis was performed on the TVC which included all subjects who received the challenge dose.|||Participants|||Count of Participants
2547698|NCT02901951|Secondary|Number of Subjects With Any Solicited General AEs|Assessed solicited general symptoms were fatigue, fever (defined as axillary temperature ≥ 37.5 degrees Celsius [°C]) , gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain) and headache. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 4-day (Days 0-3) follow-up period after the challenge dose|Analysis was performed on the TVC which included all subjects who received the challenge dose.|||Participants|||Count of Participants
2547699|NCT02901951|Secondary|Number of Subjects With Any Solicited Local Adverse Events (AEs)|Assessed solicited local symptoms were injection site pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 4-day (Days 0-3) follow-up period after the challenge dose|Analysis was performed on the Total Vaccinated cohort (TVC) which included all subjects who received the challenge dose.|||Participants|||Count of Participants
2547712|NCT02900378|Secondary|Change From Baseline in Mean Daily Non-sedentary Daytime Activity in Two-weekly Intervals|Non-sedentary physical activity is defined as >= 178.50 activity counts per minute; Mean daily non-sedentary daytime physical activity were being calculated over two-weekly intervals and compared to before the inclusion.|Baseline, Weeks 0 to 2, Weeks 2 to 4, Weeks 4 to 6, Weeks 6 to 8, Weeks 8 to 10, Weeks 10 to 12|The Full Analysis Set was considered|||minutes||Standard Deviation|Mean
2547700|NCT02901951|Secondary|Anti-HBs Antibody Concentrations|Anti-HBs antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.|At the pre-challenge dose time-point (Day 0), at 7 days post-challenge dose time-point (Day 7) and at 30 days post-challenge dose time-point (Day 30)|Analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects who had received the challenge dose of HRV vaccine and for whom data concerning immunogenicity outcome measures at pre-challenge (Day 0) and one month post-challenge (Day 30) were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2547701|NCT02901951|Secondary|Percentage of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Cut-off Values|Percentage of subjects with anti-HBs antibody concentrations ≥ 6.2 mIU/mL, ≥ 10 mIU/mL and ≥ 100 mIU/mL.|At the pre-challenge dose time-point (Day 0), at 7 days post-challenge time-point (Day 7) and at 30 days post-challenge time-point (Day 30)|Analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects who had received the challenge dose of HRV vaccine and for whom data concerning immunogenicity outcome measures at pre-challenge (Day 0) and one month post-challenge (Day 30) were available.|||Percentage of subjects||95% Confidence Interval|Number
2547702|NCT02901951|Primary|Percentage of Subjects With an Anamnestic Response to the HBV Challenge Dose, Based on the Last Available Time Point Before the Challenge Dose|Anamnestic response to the challenge dose was defined as: At least (i.e. ≥ 4-fold rise in one month post-vaccination anti-HBs antibody concentrations in previously seropositive subjects (Subjects with anti-HBs antibody concentration ≥ 6.2 mIU/mL at the pre-challenge dose time point); In previously seronegative subjects (Subjects with anti-HBs antibody concentration < 6.2 mIU/mL at the pre-challenge dose time point), anti-HBs antibody concentrations ≥10 mIU/mL at one month post-challenge dose time-point.|30 days after the challenge dose (Day 30)|Analysis was performed on the ATP cohort for analysis of immunogenicity which included all evaluable subjects who had received the challenge dose of HRV vaccine and for whom data concerning immunogenicity outcome measures at pre-challenge (Day 0) and one month post-challenge (Day 30) were available.|||Percentage of subjects||95% Confidence Interval|Number
2547703|NCT02901951|Primary|Percentage of Subjects With an Anamnestic Response to the HBV Challenge Dose, Based on the Last Available Time Point Before the Challenge Dose|Anamnestic response to the challenge dose was defined as: At least (i.e. greater than or equal to [≥]) 4-fold rise in one month post-vaccination anti-hepatitis B surface antigen (anti-HBs) antibody concentrations in previously seropositive subjects (Subjects with anti-HBs antibody concentration ≥ 6.2 milli International Unit/Milliliter (mIU/mL) at the pre-challenge dose time point); In previously seronegative subjects (Subjects with anti-HBs antibody concentration < 6.2 mIU/mL at the pre-challenge dose time point), anti-HBs antibody concentrations ≥10 mIU/mL at one month post-challenge dose time-point.|7 days after the challenge dose (Day 7)|Analysis was performed on the According-to-protocol (ATP) cohort for analysis of immunogenicity which included all evaluable subjects who had received the challenge dose of HRV vaccine and for whom data concerning immunogenicity outcome measures at pre-challenge (Day 0) and one month post-challenge (Day 30) were available.|||Percentage of subjects||95% Confidence Interval|Number
2547704|NCT02901054|Primary|CSF to Plasma Concentration Ratio|CSF: plasma ratio of ondansetron at the time of obtaining the CSF sample|0-180 min from the beginning of infusion||||Ratio||Standard Deviation|Mean
2547705|NCT02900781|Primary|Effectiveness of Step Rite Device|Effectiveness of outcomes with the use of the StepRite device|3 months|Study Terminated due to device not working at our site. No data collected||||||
2547706|NCT02900378|Secondary|Change From Baseline in Peak Six Minutes of Daytime Physical Activity|The peak 6 min walk (M6min) is a parameter derived by validated algorithms of the software that are used to preprocess actigraphy data. The parameter reflected the peak 6 minutes of day time physical activity. The mean daily 6-minute walking test was being calculated over 14 day intervals.|Baseline, Week 2, Week 4, Week 6, Week 8 and Week 12|The Full Analysis Set was considered|||minutes||Standard Deviation|Mean
2547707|NCT02900378|Secondary|Total Weekly Time Spent in Moderate-to-Vigorous Non-sedentary Daytime Physical Activity|Moderate-to-vigorous non-sedentary physical activity is defined as > 565.5 counts per minute. The total time spent in moderate-to-vigorous non-sedentary physical activity was being calculated for each patient in weekly intervals and the temporal course for each patient was assessed.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set was considered|||minutes||Standard Deviation|Mean
2547708|NCT02900378|Secondary|Total Weekly Time Spent in Light Non-sedentary Daytime Physical Activity|Light non-sedentary daytime physical activity is defined as between 178.5 - 565.5 counts per minute; The time spent in light non-sedentary physical activity was being calculated for each patient in weekly intervals and the temporal course for each patient was assessed.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set was considered|||minutes||Standard Deviation|Mean
2547709|NCT02900378|Secondary|Total Weekly Time Spent in Non-sedentary Daytime Physical Activity|Non-sedentary physical activity is defined as >= 178.5 activity counts per minute; The total time spent in non-sedentary physical activity was being calculated for each patient in weekly intervals and the temporal course for each patient was assessed.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set was considered|||minutes||Standard Deviation|Mean
2547710|NCT02900378|Secondary|Change From Baseline in Mean Daily Moderate-to-Vigorous Non-sedentary Daytime Physical Activity|The average number of minutes per day spent in moderate to vigorous non-sedentary physical activity was being calculated over 7 day epochs. Non-sedentary physical activity is defined as >= 178.5 activity counts per minute and moderate-to-vigorous activity is defined as > 565.5 counts per minute.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set was considered|||minutes||Standard Deviation|Mean
2547711|NCT02900378|Secondary|Change From Baseline in Mean Daily Light Non-sedentary Daytime Physical Activity|The average number of minutes per day spent in light non-sedentary physical activity was being calculated over 7 day epochs. Non-sedentary physical activity is defined as >= 178.5 activity counts per minute and light physical activity is defined as 178.5 - 565.5 counts per minute.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set was considered|||minutes||Standard Deviation|Mean
2547713|NCT02900378|Secondary|Change From Baseline in Mean Daily Non-sedentary Daytime Activity in Weekly Intervals|Non-sedentary physical activity is defined as >= 178.50 activity counts per minute; Mean daily non-sedentary daytime physical activity were being calculated over weekly and compared to before the inclusion.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set was considered|||minutes||Standard Deviation|Mean
2547714|NCT02900378|Secondary|Number and Percentage of Participants With Improved Symptoms of Heart Failure as Assessed by Patient Global Assessment (PGA)|The Patient Global Assessment (PGA) is a self-reported tool to assess the patients' subjective rating of their disease activity widely used in HF research. The patients are asked to report functioning or response to an intervention by rating their current condition compared to their pre-intervention condition on a numerical scale: 1) much improved 2) moderately improved 3) a little improved 4) unchanged 5) a little worse 6) moderately worse or 7) much worse. Patients with improved symptoms were categorized as: Improvement, Is unchanged, Gets worse or Missing.|Week 4, Week 8, Week 12|The Full Analysis Set was considered|||Participants|||Count of Participants
2547715|NCT02900378|Secondary|Number and Percentage of Participants Achieving PGA Score at Weeks 4, 8 and 12|The Patient Global Assessment (PGA) is a self-reported tool to assess the patients' subjective rating of their disease activity widely used in HF research. The patients are asked to report functioning or response to an intervention by rating their current condition compared to their pre-intervention condition on a numerical scale: 1) much improved 2) moderately improved 3) a little improved 4) unchanged 5) a little worse 6) moderately worse or 7) much worse.|Week 4, Week 8, Week 12|The Full Analysis Set was considered|||Participants|||Count of Participants
2547716|NCT02900378|Secondary|Number and Percentage of Participants Who Show Increased Levels (>= 10% Increase) of Non Sedentary Daytime Physical Activity at Week 12 Compared to Baseline|Non-sedentary physical activity is defined as >= 178.50 activity counts per minute; the average number of minutes per day spent in non-sedentary physical activity will be calculated over 14 days before randomization (baseline) and the last 14 days of treatment (i.e week 10 to week 12)|Baseline, Week 12|The Full Analysis Set was considered|||Participants|||Count of Participants
2547717|NCT02900378|Secondary|Change From Baseline (Week 0) in the Six Minute Walk Test (6MWT) at Weeks 4 and 8|The impact of LCZ696 (Sacubitril/Valsartan) and Enalapril on functional exercise capacity was measured by the Six Minute Walk Test at Weeks 4 and 8. The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway.|Baseline, Week 4 and Week 8|The Full Analysis Set (FAS) and FAS population subset without AE/SAE were considered.|||meters||Standard Deviation|Mean
2547718|NCT02900378|Secondary|Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked 100-450 Meters at Baseline - FAS Subset Without AE/SAE|The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group in a subset of patients with baseline six-minute walk distance from 100 to 450 meters.|Baseline, Week 12|The Full Analysis Set (FAS) population subset without AE/SAE was considered for patients with Baseline 6MWT between 100 or above and less than 450 meters.|||Participants|||Count of Participants
2547719|NCT02900378|Secondary|Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked 100-450 Meters at Baseline - FAS|The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group in a subset of patients with baseline six-minute walk distance from 100 to 450 meters.|Baseline, Week 12|The Full Analysis Set (FAS) was considered for patients with Baseline 6MWT between 100 or above and less than 450 meters.|||Participants|||Count of Participants
2547720|NCT02900378|Secondary|Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked Equal to or Less Than 300 Meters at Baseline - FAS Subset Without AE/SAE|The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group in a subset of patients with baseline six-minute walk distance equal to or less than 300 meters.|Baseline, Week 12|The Full Analysis Set (FAS) population subset without AE/SAE was considered for patients with Baseline 6MWT equal to or less than 300 meters.|||Participants|||Count of Participants
2547721|NCT02900378|Secondary|Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked Equal to or Less Than 300 Meters at Baseline - FAS|The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group in a subset of patients with baseline six-minute walk distance equal to or less than 300 meters.|Baseline, Week 12|The Full Analysis Set (FAS) was considered for patients with Baseline 6MWT equal to or less than 300 meters.|||Participants|||Count of Participants
2547722|NCT02900378|Secondary|Number and Percentage of Participants With Improved Performance (>= 30 m) in the Six Minute Walk Test (6MWT) - FAS Subset Without AE/SAE|The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group.|Baseline, Week 12|The Full Analysis Set (FAS) population subset without AE/SAE was considered.|||Participants|||Count of Participants
2547723|NCT02900378|Secondary|Number and Percentage of Participants With Improved Performance (>= 30 m) in the Six Minute Walk Test (6MWT) - FAS|The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group.|Baseline, Week 12|The Full Analysis Set (FAS) was considered.|||Participants|||Count of Participants
2547724|NCT02900378|Primary|Change From Baseline (Week 0) in Mean Daily Non-sedentary Daytime Activity at End of Study (Week 12)|Non-sedentary physical activity is defined as >= 178.50 activity counts per minute; the average number of minutes per day spent in non-sedentary physical activity is being calculated over 14 days before randomization (baseline i.e. week -2 to week 0) and the last 14 days of treatment (i.e. week 10 to week 12).|Baseline, Week 12|The FAS population with Multiple Imputation (MI), with Last Observation Carried Forward (LOCF) and without MI/LOCF were considered.|||minutes||Standard Deviation|Mean
2547757|NCT02898974|Primary|Muscle Strength|Maximal muscle strength measured with force transducer|Through study completion, an average of 6 months.|Twenty Two participants were enrolled in the study. Analysis was performed on sixteen people with Multiple Sclerosis, eight cannabis users and age/sex matched non-users.|||Newton||Standard Deviation|Mean
2547725|NCT02900378|Primary|Change From Baseline (Week 0) in the Six Minute Walk Test (6MWT) at End of Study (Week 12)|The impact of LCZ696 (Sacubitril/Valsartan) and Enalapril on functional exercise capacity was measured by the Six Minute Walk Test at 12 weeks. The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway.|Baseline, Week 12|The Full Analysis Set (FAS) and FAS population subset without AE/SAE were considered|||meters||Standard Deviation|Mean
2547726|NCT02900092|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS is a diagnostic questionnaire that is used to measure the severity of depressive episodes in patients with mood disorders. The minimum and maximum values are 0 and 60, respectively, (higher scores are more severe).|Week 8|Ten subjects started the study. One subject dropped out (did not complete the 8-week study). Therefore, data from 9 subjects were analyzed.|||units on a scale||Standard Deviation|Mean
2547727|NCT02899884|Secondary|Participant's Performance as Assessed by the Karnofsky Scale Score|Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (participant asymptomatic with no evidence of illness). Higher score means higher ability to perform daily tasks. Participants with missing values in the Karnofsky scale were assigned to the worst score of 0, however, in these cases it is not 'death'.|Month 1|Prevalence Study Population included participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database with data available for this outcome measure.|||percentage of participants|||Number
2547728|NCT02899884|Secondary|Quality of Life Assessment Using the Short Form-12 (SF-12) Questionnaire Score|The SF-12 health questionnaire is a 12 question assessment of functional health and well-being. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 (poor mental and physical quality of life) and 100 (better mental and physical quality of life).|Month 1|Participants from Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database with breakthrough cancer pain who did not take any treatment for it and who administered the scale with data available for this outcome measure.|||score on a scale||Standard Deviation|Mean
2547729|NCT02899884|Secondary|Pain Assessment Using the Numeric Rating Scale||Month 1|Data was not collected for this outcome measure.||||||
2547730|NCT02899884|Secondary|Pain Severity and Pain Interference as Assessed by Brief Pain Inventory (BPI) Questionnaire Score|The BPI questionnaire was used to assess the pain intensity (4 items) and interference with activities of daily living (7 items). Each item was given a score on a numerical scale from 0 (no pain/interference with activities of daily living) to 10 (worst pain imaginable/maximum impact on activities of daily living). The total score for pain intensity is the average of the four pain items. The total score of pain interference is the average score of the seven interference items. The higher score represents high impact.|Month 1|Participants from Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database with breakthrough cancer pain who did not take any treatment for it and who administered the scale. Number analyzed is the participants with data available for the given category.|||score on a scale||Standard Deviation|Mean
2547731|NCT02899884|Secondary|Pain Characterization With the Alberta Breakthrough Pain Assessment|The Alberta Breakthrough Pain Assessment Tool (ABPAT) consisted of a participant's self-reporting section (15 questions) out of which 4 questions of the tool were not included as they were related to the treatment for breakthrough cancer pain. The questions included: Q1-Relationship to baseline pain, Q2a-Last time experienced, Q3b-Frequency, Q4b-Intensity of pain at peak, Q5-Location (most frequent - ≥5%), Q6-Quality (those present in ≥20%), Q7-Time from onset to peak intensity, Q8-Time from onset [take medication] to end of episode, Q9-Cause(s) (triggers) (Those present in ≥20%), Q10-Predictability, Q11-General relief (those present in ≈20% or more participants) and questions completed by nurse/physician (N/P), Q1-Etiology of breakthrough pain, Q2-Inferred pathophysiology of breakthrough pain. Percentage of participants were categorized into the answers for each of these questions.|Month 1|Participants from Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database with breakthrough cancer pain who did not take any treatment for it and who administered the scale. Number analyzed is the participants with data available for the given question.|||percenatge of participants|||Number
2547732|NCT02899884|Secondary|Percentage of New Participants Diagnosed With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation|Participants diagnosed during the study and were not diagnosed previously were reported as new participants with breakthrough cancer pain. Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.|Month 1|Participants with cancer pain from the Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database, with data available for the time of diagnosis of breakthrough cancer pain.|||percentage of participants||95% Confidence Interval|Number
2547733|NCT02899884|Secondary|Number of New Participants Diagnosed With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation|Participants diagnosed during the study and were not diagnosed previously were reported as new participants with breakthrough cancer pain. Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.|Month 1|Prevalence Study Population included participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database. Number analyzed is the total number of participants with data available for the time of diagnosis of breakthrough cancer pain.|||Participants|||Count of Participants
2547734|NCT02899884|Primary|Percentage of Cancer Participants With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation|Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.|Month 1|Participants with cancer pain from the Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database.|||percentage of participants||95% Confidence Interval|Number
2547735|NCT02899884|Primary|Percentage of Cancer Participants With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation|Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.|Month 1|Prevalence Study Population included participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database.|||percentage of participants||95% Confidence Interval|Number
2547736|NCT02899377|Secondary|Correlation Between Static and Dynamic Imaging Metrics in 11C-MET|Blood samples were collected at indicated time points for analysis. Pearson's correlation is presented along with 95% confidence interval.|0.1, 0.4, 0.6, 0.9, 1.1, 1.4, 1.6, 1.9, 2.5, 3.5, 4.5, 6.0, 8, 10, 12, 14, 17.5, 22.5, 27.5, 32.5 and 37.5 minutes post-injection|PK Population|||Grams per milliliter||95% Confidence Interval|Number
2547737|NCT02899377|Secondary|Net Irreversible Influx Rate Constant (Ki) From 11C-MET PET/CT|Blood samples were collected at indicated time points for radio-pharmacokinetic analysis of Ki. Pharmacokinetic (PK) Population included those participants in the 'Safety' population for whom a radio-pharmacokinetic sample was obtained and analyzed. Data for lower value of region (low), higher value of region (high) and right-left combined values (aggregated) is presented.|0.1, 0.4, 0.6, 0.9, 1.1, 1.4, 1.6, 1.9, 2.5, 3.5, 4.5, 6.0, 8, 10, 12, 14, 17.5, 22.5, 27.5, 32.5 and 37.5 minutes post-injection|PK Population|||Milliliter/centimeter cube/minute||Standard Deviation|Mean
2547738|NCT02899377|Primary|Multi-parametric MRI Derived Parameter: Exchange Rate (KTrans)|Quantitative parameters like KTrans assessed use of multi-parametric MRI in the assessment of uptake in selected body areas like lachrymal gland, parotid gland, and submandibular gland. The median and IQR values were used for analysis. Data for lower value of region, higher value of region, and aggregated value which includes left and right region combined value has been reported.|Visit 1: Within 6 weeks after Baseline|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Per minute||Standard Error|Mean
2547739|NCT02899377|Primary|Multi-parametric MRI Derived Parameter: Microvascular Volume Fraction|Quantitative parameters like Microvascular Volume Fraction assessed use of multi-parametric MRI in selected body areas like lachrymal gland, parotid gland, and submandibular gland. The median and IQR values were used for analysis. Data for lower value of region, higher value of region, and aggregated value which includes left and right region combined value has been reported. The IVIM (intra-voxel incoherent motion) model estimates two separate pools of diffusion (for a microvascular component and a tissue component). Pool one describes fraction (f) of the signal. Pool two describes fraction (1-f) of the signal. Microvascular Volume Fraction (f) is the ratio of the signal contribution of the microvascular pool (pool one) over the entire signal.|Visit 1: Within 6 weeks after Baseline|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Ratio||Standard Error|Mean
2547740|NCT02899377|Primary|Multi-parametric MRI Derived Parameter: Pure Diffusion Coefficient (D)|Quantitative parameters like pure D assessed the use of multi-parametric MRI in the assessment of uptake in selected body areas like lachrymal gland, parotid gland, and submandibular gland. The median and IQR values for pure D was used for analysis. Data for lower value of region, higher value of region, and aggregated value which includes left and right region combined value has been reported.|Visit 1: Within 6 weeks after Baseline|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||10^-3 square millimeter per second||Standard Error|Mean
2547741|NCT02899377|Primary|Multi-parametric MRI Derived Parameter: Apparent Diffusion Coefficient (ADC)|Quantitative parameters like ADC assessed use of multi-parametric MRI in the assessment of uptake in selected body areas like lachrymal gland, parotid gland, and submandibular gland. The median and interquartile range (IQR) values for ADC was used for analysis. Data for lower value of region (low), higher value of region (high), and aggregated value which includes left and right region combined value has been reported.|Visit 1: Within 6 weeks after Baseline|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||10^-3 square millimeter per second||Standard Error|Mean
2547742|NCT02899377|Primary|Total Inflammatory Volume 11C- MET at Selected Body Areas|There were no anatomically relevant areas indicative of inflamed tissue and/or focal uptake within the organs that would warrant calculation of TIV.|Visit 1: Within 6 weeks after Baseline|Safety Population. Data was not collected||||||
2547743|NCT02899377|Primary|TR Ratio for 11C- MET of Salivary Glands, Lachrymal Gland, Parotid Gland, and Submandibular Gland|Semi-quantitative parameters used for the assessment of uptake included TR ratio for following selected body areas: lachrymal gland, parotid gland, and submandibular gland. Data from static scan for lower value of region (low), higher value of region (high), and aggregated value which includes left and right region combined value has been reported.|Visit 1: Within 6 weeks after Baseline|Safety Population. Only those participants with data available at the specified data points were analyzed|||Ratio||Standard Deviation|Mean
2547744|NCT02899377|Primary|TR Ratio for 11C- MET|Semi-quantitative parameters used for the assessment of uptake included TR ratio for following selected body areas: aorta, liver, muscle, lumbar vertebra, pancreas, salivary gland, spleen, and thyroid. Data from static scan has been reported.|Visit 1: Within 6 weeks after Baseline|Safety Population. Only those participants with data available at the specified data points were analyzed|||Ratio||Standard Deviation|Mean
2547758|NCT02898974|Primary|Fatigue|Strength decline during fatiguing muscle contraction measured with force transducer|Through study completion, an average of 6 months.|Twenty Two participants were enrolled in the study. Analysis was performed on sixteen people with Multiple Sclerosis, eight cannabis users and age/sex matched non-users. Matching was only possible for 16 subjects. The remaining 6 subjects were not included in the analysis.|||% decline||Standard Deviation|Mean
2547745|NCT02899377|Primary|SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 11C-MET|Semi-quantitative parameters used for the assessment of uptake included Mean, Peak and Max SUV for following selected body areas: lachrymal gland, parotid gland, and submandibular gland. Data from static scan for lower value of region (low), higher value of region (high), and aggregated value which includes left and right region combined value has been reported. SUV is a mathematically derived ratio of tissue radioactivity concentration and the injected dose of radioactivity per kilogram of the participant's body weight at a given point in time.|Visit 1: Within 6 weeks after Baseline|Safety Population. Only those participants with data available at the specified data points were analyzed|||Grams per milliliter||Standard Deviation|Mean
2547746|NCT02899377|Primary|SUV for 11C- MET in Selected Body Areas|Semi-quantitative parameters used for the assessment of uptake included Mean, Peak and Max SUV for following selected body areas: aorta, liver, muscle, lumbar vertebra, pancreas, salivary gland, spleen, and thyroid. Data from static scan is reported.|Visit 1: Within 6 weeks after Baseline|Safety Population. Only those participants with data available at the specified data points were analyzed|||Grams per milliliter||Standard Deviation|Mean
2547747|NCT02899377|Primary|Total Inflammatory Volume for 18F- FDG for pSS Participants at Selected Body Areas|There were no anatomically relevant areas indicative of inflamed tissue and/or focal uptake within the organs that would warrant calculation of TIV|Visit 1: Within 6 weeks after Baseline|Safety Population. Data was not collected||||||
2547748|NCT02899377|Primary|TR Ratio of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants|Semi-quantitative parameters used for the assessment of glucose uptake included TR ratio for following selected body areas: lachrymal gland, parotid gland, and submandibular gland. Data for lower value of region (low), higher value of region (high), and aggregated value which includes left and right region combined value has been reported.|Visit 1: Within 6 weeks after Baseline|Safety Population|||Ratio||Standard Deviation|Mean
2547749|NCT02899377|Primary|Tissue to Reference (TR) Ratio for 18F- FDG for pSS Participants|Semi-quantitative parameters used for the assessment of glucose uptake included TR ratio for the following selected body areas: aorta, liver, lumbar vertebra, muscle, pancreas, salivary gland, spleen, and thyroid.|Visit 1: Within 6 weeks after Baseline|Safety Population|||Ratio||Standard Deviation|Mean
2547750|NCT02899377|Primary|SUV of Lachrymal Gland, Parotid Gland, and Submandibular Gland for 18F-FDG for pSS Participants|Semi-quantitative parameters used for the assessment of glucose uptake included Mean, Peak and Max SUV for following selected body areas: lachrymal gland, parotid gland, and submandibular gland. Data for lower value of region (low), higher value of region (high), and aggregated value which is left and right region combined value has been reported for the regions of interest. SUV is a mathematically derived ratio of tissue radioactivity concentration and the injected dose of radioactivity per kilogram of the participant's body weight at a given point in time.|Visit 1: Within 6 weeks after Baseline|Safety Population|||Grams per milliliter||Standard Deviation|Mean
2547751|NCT02899377|Primary|Standardized Uptake Value (SUV) for 18F-FDG for pSS Participants in Selected Body Areas|Semi-quantitative parameters used for the assessment of glucose uptake included Mean, Peak and Max SUV for following selected body areas: aorta, liver, muscle, pancreas, lumbar vertebra, salivary gland, spleen, and thyroid. Safety Population included all participants who underwent any procedure on or after Visit 1.|Visit 1: Within 6 weeks after Baseline|Safety Population|||Grams per milliliter||Standard Deviation|Mean
2547752|NCT02899338|Secondary|The Percentage of Subjects With Drug-related Treatment-emergent Adverse Events (TEAEs) From Day 1 to Day 70.|A treatment-related TEAE was defined as any TEAE assessed by the Investigator as related to the trial medication. A TEAE was defined as an adverse event (AE) that started or worsened in severity on or after the single dose of trial medication up to 10 weeks (70 days) post-dose.|From Day 1 to Day 70|All treated subjects (i.e. all subjects who received 1 dose of trial medication) were included in the safety analysis set (SAF).|||Percentage of participants|||Number
2547753|NCT02899338|Primary|Area Under the Concentration-time Curve of BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) After Administration Via PFS and AI.|The AUC0-∞ of 40 mg BI 695501 administered via PFS and AI. Plasma concentrations were measured using a validated ELISA. Only concentration values within the validated concentration range of 0.025 to 2.0 µg/mL and actual sampling times were used.|Samples were collected pre-dose and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 216, 336, 504, 672, 840, 1032, and 1368 hours post-dose.|PKS|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2547754|NCT02899338|Primary|The Maximum Measured Concentration of BI 695501 in Plasma (Cmax) After Administration Via PFS and AI|The Cmax of 40 mg BI 695501 administered via PFS and AI. Plasma concentrations were measured using a validated ELISA. Only concentration values within the validated concentration range of 0.025 to 2.0 µg/mL and actual sampling times were used.|From 0 to 1368 hours post-dose. Samples were collected pre-dose and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 216, 336, 504, 672, 840, 1032, and 1368 hours post-dose.|PKS|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2547755|NCT02899338|Primary|Area Under the Concentration-time Curve of BI 695501 in Plasma Over the Time Interval From 0 to 1368 Hours (AUC0-1368) After Administration Via PFS and AI.|The AUC0-1368 of 40 mg BI 695501 administered via PFS and AI was measured. Plasma concentrations were measured using a validated enzyme-linked immunosorbent assay (ELISA). Only concentration values within the validated concentration range of 0.025 to 2.0 micrograms per millilitre (µg/mL) and actual sampling times were used.|From 0 to 1368 hours post-dose. Samples were collected pre-dose and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 216, 336, 504, 672, 840, 1032, and 1368 hours post-dose.|PKS: The pharmacokinetic set (PKS) consisted of all randomized subjects who received the single dose of trial medication (BI 695501 administered via PFS or AI), had at least 1 evaluable primary PK parameter, and were without important protocol deviations or violations thought to significantly affect the PK of BI 695501.|||microgram hour per milliliter (μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2547756|NCT02898974|Primary|Postural Stability|Timed up and go|Through study completion, an average of 6 months.|Twenty Two participants were enrolled in the study. Analysis was performed on sixteen people with Multiple Sclerosis, eight cannabis users and age/sex matched non-users.|||Seconds||Standard Deviation|Mean
2547904|NCT02896361|Primary|Visual Analog Scale (VAS) for Pain|Standard evaluation of pain intensity. Scale goes from 0 to 100 millimiters. 0 means no pain, 100 means strongest imaginable pain|assessed every 2 weeks after each intervention, for a total of 6 weeks||||units on a scale||Standard Deviation|Mean
2547759|NCT02898740|Primary|Change in Hamilton Rating Scale for Depression (HAM-D) From Baseline to 6 Months|The HAM-D is the most widely used and accepted measure for evaluating depression severity. The HAM-D scores range from a minimum of 0 to a maximum of 50. Higher scores indicate more severe depression. Change = (6 month score) - (baseline score).|Baseline and 6 months||||units on a scale||Full Range|Mean
2547760|NCT02898662|Secondary|LS Mean Fractional Exhaled Nitric Oxide (FeNO) (Weekly) Over 52 Weeks|FeNO measurements were taken at home by participants every second day. The weekly average FeNO was based on the average of measurements taken at home for a specific week. Estimates of the LS mean over 52 weeks were analyzed using a repeated measures analysis with treatment, baseline FeNO, week and treatment-by-week with participant as random effects, and age and gender as covariates. Baseline was the average of non-missing daily measures/scores over the last 5 days prior to and including the morning of randomization.|Baseline (Week 0) up to Week 52|The FAS included all randomized participants who received any IP, irrespective of their protocol adherence and continued participation in the study. Only participants with data available for analysis are presented.|||parts per billion||Standard Error|Least Squares Mean
2547761|NCT02898662|Secondary|LS Mean Total PEF (Weekly) Over 52 Weeks|Morning and evening PEF measurements were recorded by the participant on a daily basis and then averaged over the week. The weekly average total PEF was calculated by taking the sum of the average of the weekly morning mean and weekly evening mean. Estimates of the LS mean over 52 weeks were analyzed using a repeated measures analysis with treatment, baseline PEF, week and treatment-by-week with participant as random effects, and age and gender as covariates. Baseline was the average of non-missing daily measures/scores over the last 5 days prior to and including the morning of randomization.|Baseline (Week 0) up to Week 52|The FAS included all randomized participants who received any IP, irrespective of their protocol adherence and continued participation in the study. Only participants with data available for analysis are presented.|||Liters/minute||Standard Error|Least Squares Mean
2547762|NCT02898662|Secondary|LS Mean Pre- and Post-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1) Over 52 Weeks|Lung function was assessed by pre- and post-BD FEV1 which was measured by spirometry. To ensure quality control, all spirometry measurements were reviewed to ensure that they met American Thoracic Society / European Respiratory Society criteria for acceptability. Estimates of the LS mean over 52 weeks were analyzed using a repeated measures analysis with treatment, baseline FEV1 (pre- or post-BD, as applicable), visit and treatment-by-visit with participant as random effects, and age and gender as covariates. Baseline was the last non-missing measurement recorded prior to randomization.|Baseline (Week 0) up to Week 52|The FAS included all randomized participants who received any IP, irrespective of their protocol adherence and continued participation in the study. Only participants with data available for analysis are presented.|||Liters||Standard Error|Least Squares Mean
2547763|NCT02898662|Secondary|Percentage of Participants Using Reliever Medication up to Week 52|The use of SABAs was allowed as rescue medication (reliever bronchodilator) throughout the study. Reliever medication use was captured in the Asthma Daily Diary twice daily (morning and evening), recorded as the number of inhaler puffs. The number of inhalations (puffs) per day was calculated as: number of night inhaler puffs + number of day inhaler puffs. Percentage of participants using reliever medication (SABA) up to Week 52 is presented.|Baseline (Week 0) up to Week 52|The FAS included all randomized participants who received any IP, irrespective of their protocol adherence and continued participation in the study.|||percentage of participants|||Number
2547764|NCT02898662|Secondary|Number of Participants With Events for Time to Moderate Or Severe Exacerbation up to Week 52|"Moderate exacerbation was defined as a temporary increase in maintenance therapy to prevent a severe event supported by sustained (≥ 2 day) worsening in at least 1 key control metric ie, asthma score, reliever medication use, night time awakening or morning PEF.~Severe exacerbation was defined as a worsening in asthma symptoms and:~Use of systemic corticosteroids for at least 3 days and/or~An unscheduled or emergency room visit due to asthma symptoms requiring systemic corticosteroids and/or~An in-patient hospitalization due to asthma requiring systemic corticosteroids. Time to moderate or severe asthma exacerbation was calculated as start date of first moderate or severe exacerbation - date of randomization + 1. Time to moderate or severe asthma exacerbation was displayed using a Kaplan-Meier plot and the outcome measure is presented as number of participants with events."|Baseline (Week 0) up to Week 52|The FAS included all randomized participants who received any IP, irrespective of their protocol adherence and continued participation in the study.|||Participants|||Count of Participants
2547765|NCT02898662|Secondary|LS Mean Asthma Daily Diary Score (Weekly Total) Over 52 Weeks|Asthma symptoms during night-time and daytime were recorded by the participant each morning and evening in the Asthma Daily Diary. Symptoms were recorded using a 4-point response scale, which ranged from 0 to 3, where 0 indicated no asthma symptoms. Asthma symptom daytime score (recorded in the evening), night-time score (recorded in the morning), and total score were calculated separately. The daily asthma symptom total score was calculated by taking the sum of the night-time and daytime asthma symptom scores recorded each day, ranging from 0 to 6. A lower symptom score indicated a better outcome. Estimates of the LS mean over 52 weeks were analyzed using a repeated measures analysis with treatment, baseline asthma daily diary weekly average, week and treatment-by-week with participant as random effects, and age and gender as covariates. Baseline was the average of non-missing daily measures/scores over the last 5 days prior to and including the morning of randomization.|Baseline (Week 0) up to Week 52|The FAS included all randomized participants who received any IP, irrespective of their protocol adherence and continued participation in the study. Only participants with data available for analysis are presented.|||scores on a scale||Standard Error|Least Squares Mean
2547795|NCT02898454|Secondary|Change From Baseline at Week 24 in Nasal Peak Inspiratory Flow (NPIF)|NPIF evaluation represented a physiologic measure of the air flow through both nasal cavities during forced inspiration expressed in liters per minute. Higher NPIF values were indicative of better nasal air flow. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.|Baseline, Week 24|Analysis was performed on ITT population. Data for this outcome measure was planned to be analyzed for the combined population of participants who received dupilumab.|||liters per minute||Standard Error|Least Squares Mean
2547766|NCT02898662|Secondary|Least Squares (LS) Mean ACQ-5 Score Over 52 Weeks|"In the ACQ-5 questionnaire, participants were asked to recall the status of their asthma during the previous week with regards to symptoms. The questionnaire included the items:~Awoken at night by asthma symptoms.~Severity of asthma symptoms in the morning.~Limitation of daily activities due to asthma.~Shortness of breath.~Wheeze. The ACQ-5 score was computed as the un-weighted mean of responses to the 5 items, measured on a 7-point scale from 0 (totally controlled) to 6 (severely uncontrolled). A lower score indicated a better outcome. If ACQ-5 reached a value of 1.5 or more, the participant was reported as having LOAC. Estimates of the LS mean over 52 weeks were analyzed using a repeated measures analysis with treatment, baseline ACQ-5, week and treatment-by-week with participant as random effects, and age and gender as covariates. Baseline was the average of non-missing daily measures/scores over the last 5 days prior to and including the morning of randomization."|Baseline (Week 0) up to Week 52|The FAS included all randomized participants who received any IP, irrespective of their protocol adherence and continued participation in the study. Only participants with data available for analysis are presented.|||scores on a scale||Standard Error|Least Squares Mean
2547767|NCT02898662|Secondary|Number of Participants Experiencing LOAC up to Week 52 - Generalized Estimating Equation Analysis|"LOAC was defined as any of the following:~Increase of ACQ-5 to ≥ 1.5.~≥ 30% reduction in morning PEF from baseline on 2 consecutive days.~≥ 6 additional reliever inhalations of SABA in a 24-hour period relative to baseline on 2 consecutive days.~Exacerbation requiring systemic corticosteroids. Number of participants experiencing LOAC up to Week 52 is presented. A generalized linear model based on a generalized estimating equation was used to compare treatments."|Baseline (Week 0) up to Week 52|The FAS included all randomized participants who received any IP, irrespective of their protocol adherence and continued participation in the study.|||Participants|||Count of Participants
2547768|NCT02898662|Primary|Number of Participants With Events for Time to Loss of Asthma Control (LOAC) up to Week 52 - Cox Regression Analysis|"LOAC was defined as any of the following:~Increase of asthma control questionnaire-5 (ACQ-5) to ≥ 1.5.~≥ 30% reduction in morning peak expiratory flow (PEF) from baseline on 2 consecutive days.~≥ 6 additional reliever inhalations of short-acting β agonist (SABA) in a 24-hour period relative to baseline on 2 consecutive days.~Exacerbation requiring systemic corticosteroids as decided by Investigator. Time to LOAC was calculated as start date of first LOAC - date of randomization + 1. Start date of LOAC was latest date that 1 of the 4 criteria were satisfied immediately prior to the exacerbation start date, provided no more than 7 days between LOAC and exacerbation start date. Time to LOAC was displayed using a Kaplan-Meier plot and the outcome measure is presented as number of participants with events. Cox regression analysis was used to compare treatments."|Baseline (Week 0) up to Week 52|The FAS included all randomized participants who received any IP, irrespective of their protocol adherence and continued participation in the study.|||Participants|||Count of Participants
2547769|NCT02898597|Primary|Number of Participants With Abstinence|Self-reported abstinence since the quit day, which will be verified with a salivary cotinine test at both 3-month and 6-month follow-ups|6-month follow-up|Women living with HIV|||Participants|||Count of Participants
2547770|NCT02898454|Secondary|Number of Participants With Treatment-Emergent And Treatment-Boosted Anti-drug Antibodies Response (ADA)|ADA response were categorized as: treatment emergent and treatment boosted response. 1) Treatment emergent was defined as a positive response in the ADA assay post first dose, when baseline results are negative or missing. 2) Treatment boosted was defined as: an ADA positive response in the assay post first dose that is greater-than or equal to 4-fold over baseline titer levels, when baseline results are positive.|Baseline to Week 52|The analysis was performed on ADA population which included participants who received at least 1 dose of IMP with at least one evaluable ADA serum sample that was assayed successfully in the ADA assay (either ‘ADA negative’ or ‘ADA positive’) following the first dose of the study medication.|||Participants|||Count of Participants
2547771|NCT02898454|Secondary|Functional Dupilumab Concentration in Serum||Baseline, Week 2, Week 4, Week 16, Week 24, Week 40, End of treatment (Week 52), End of study (Week 64)|Analysis performed on pharmacokinetics population (PK) which included all participants who received at least 1 dose of IMP with at least 1 evaluable functional dupilumab concentration result. Here, ‘number analyzed’ = number of participants with available data for each time point. PK data was not collected and assessed for the placebo arm.|||nanogram/milliliter||Standard Deviation|Mean
2547772|NCT02898454|Secondary|Change From Baseline at Week 52 in European Quality of Life 5 Dimension Scale Visual Analog Scale Score|The EQ-5D was a standardized HRQoL questionnaire consisting of EQ-5D descriptive system and EQ VAS. The EQ-5D descriptive system comprised of 5 dimensions: mobility, selfcare, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. EQ VAS recorded the participant's self-rated health on a vertical VAS that allowed them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable).|Baseline, Week 52|Analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547773|NCT02898454|Secondary|Change From Baseline at Week 24 in European Quality of Life 5 Dimension Scale (EQ-5D) Visual Analog Scale Score|The EQ-5D was a standardized HRQoL questionnaire consisting of EQ-5D descriptive system and EQ VAS. The EQ-5D descriptive system comprised of 5 dimensions: mobility, selfcare, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. EQ VAS recorded the participant's self-rated health on a vertical VAS that allowed them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable). All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.|Baseline, Week 24|Analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.|||score on a scale||Standard Error|Least Squares Mean
2547839|NCT02897115|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity|The Patient's Global Assessment of Disease Activity was assessed using an NRS from 0 (no disease activity) to 10 (very severe disease activity).|Baseline, week 32, and week 52|Participants with available data at baseline and each time point|||score on a scale||Standard Deviation|Mean
2547774|NCT02898454|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs Leading to Treatment Discontinuation|An Adverse Event (AE) was defined as any untoward medical occurrence that did not necessarily have to have a causal relationship with the study treatment. TEAEs were defined as AEs that developed or worsened in grade or became serious during TEAE period which was defined as the period from the time of first dose of drug until 84 days following the last administration of drug. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event.|Baseline up to 84 days after last dose of study drug (up to 64 weeks)|Analysis was performed on safety population which included all participants who received at least 1 dose or part of a dose of the investigational medicinal product (IMP), analyzed according to the treatment actually received.|||Participants|||Count of Participants
2547775|NCT02898454|Secondary|Change From Baseline at Week 52 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Prior Nasal Polyp Surgery|The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, and regions as covariates.|Baseline, Week 52|Analysis was performed on a subset of participants which included all randomized participants with prior NP surgery history and had available data for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547776|NCT02898454|Secondary|Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Prior Nasal Polyp Surgery|The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.|Baseline, Week 24|Analysis was performed on a subset of participants which included all randomized participants with prior NP surgery history and had available data for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547777|NCT02898454|Secondary|Change From Baseline at Week 52 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Asthma|The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.|Baseline, Week 52|Analysis was performed on a subset of participants which included all randomized participants with asthma and had available data for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547778|NCT02898454|Secondary|Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay Score: Subgroup of Participants With Asthma|The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.|Baseline, Week 24|Analysis was performed on a subset of participants which included all randomized participants with asthma and had available data for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547779|NCT02898454|Secondary|Change From Baseline at Week 52 in Nasal Polyp Score: Subgroup of Participants With Prior Nasal Polyp Surgery|NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model.|Baseline, Week 52|Analysis was performed on a subset of participants which included all randomized participants with prior NP surgery history and had available data for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547796|NCT02898454|Secondary|Change From Baseline at Week 52 in Visual Analogue Scale for Rhinosinusitis|"The VAS for rhinosinusitis was used to evaluate the total disease severity. The participants were asked to indicate on a 10 centimeters VAS the answer to the question, How troublesome are your symptoms of your rhinosinusitis? The range of the VAS was from 0 (not troublesome) to 10 (worse thinkable troublesome), where higher score indicated worse thinkable troublesome. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates."|Baseline, Week 52|Analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||centimeters||Standard Error|Least Squares Mean
2547780|NCT02898454|Secondary|Change From Baseline at Week 24 in Nasal Polyp Score: Subgroup of Participants With Prior Nasal Polyp Surgery|NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.|Baseline, Week 24|Analysis was performed on a subset of participants which included all randomized participants with prior NP surgery history and had available data for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547781|NCT02898454|Secondary|Change From Baseline at Week 52 in Nasal Polyp Score: Subgroup of Participants With Asthma|NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model.|Baseline, Week 52|Analysis was performed on a subset of participants which included all randomized participants with asthma and had available data for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547782|NCT02898454|Secondary|Change From Baseline at Week 24 in Nasal Polyp Score: Subgroup of Participants With Asthma|NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS mean and SE were obtained from ANCOVA model. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.|Baseline, Week 24|Analysis was performed on a subset of participants which included all randomized participants with asthma and had available data for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547783|NCT02898454|Secondary|Change From Baseline at Week 52 in Nasal Congestion/Obstruction Symptom Severity Score: Subgroup of Participants With Prior Nasal Polyp Surgery|NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline, treatment group, asthma/NSAID-ERD status, and regions as covariates.|Baseline, Week 52|Analysis was performed on a subset of participants which included all randomized participants with prior NP surgery history.|||score on a scale||Standard Error|Least Squares Mean
2547784|NCT02898454|Secondary|Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score: Subgroup of Participants With Prior Nasal Polyp Surgery|NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.|Baseline, Week 24|Analysis was performed on a subset of participants which included all randomized participants with prior NP surgery history.|||score on a scale||Standard Error|Least Squares Mean
2547785|NCT02898454|Secondary|Change From Baseline at Week 52 in Nasal Congestion/Obstruction Symptom Severity Score: Subgroup of Participants With Asthma|NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates.|Baseline, Week 52|Analysis was performed on a subset of participants which included all randomized participants with asthma.|||score on a scale||Standard Error|Least Squares Mean
2547786|NCT02898454|Secondary|Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score: Subgroup of Participants With Asthma|NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting ANCOVA model with corresponding baseline, treatment group, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.|Baseline, Week 24|Analysis was performed on a subset of participants which included all randomized participants with asthma.|||score on a scale||Standard Error|Least Squares Mean
2547834|NCT02897115|Secondary|Change From Baseline in Dactylitis Count|Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as 0 for no dactylitis or 1 for dactylitis present. The dactylitis count, ranging from 0 to 20, is the total number of digits on the hands and feet with dactylitis present.|Baseline, week 32, and week 52|Participants with available data at baseline and each time point|||digits with dactylitis||Standard Deviation|Mean
2547787|NCT02898454|Secondary|Change From Baseline at Week 52 in Asthma Control Questionnaire-6 for Participants With Asthma|ACQ-6 had 6 questions which assessed the most common asthma symptoms (woken by asthma, symptoms on waking, activity limitation, shortness of breath, wheezing, puffs/inhalations use). Participants were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale ranged from 0 = no impairment to 6 = maximum impairment. The ACQ-6 score was the mean of the scores of all 6 questions and therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), with higher scores indicated lower asthma control. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment, asthma status, prior surgery history, and regions as covariates.|Baseline, Week 52|Analysis was performed on a subset of participants which included all randomized participants with Asthma and had available data for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547788|NCT02898454|Secondary|Change From Baseline at Week 24 in Asthma Control Questionnaire-6 (ACQ-6) for Participants With Asthma|ACQ-6 had 6 questions which assessed the most common asthma symptoms (woken by asthma, symptoms on waking, activity limitation, shortness of breath, wheezing, puffs/inhalations use). Participants were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale ranged from 0 = no impairment to 6 = maximum impairment. The ACQ-6 score was the mean of the scores of all 6 questions and therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled), with higher scores indicated lower asthma control. Data were analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment, asthma status, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.|Baseline, Week 24|Analysis was performed on a subset of participants which included all randomized participants with asthma and had available data for this outcome measure. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.|||score on a scale||Standard Error|Least Squares Mean
2547789|NCT02898454|Secondary|Change From Baseline at Week 52 in Forced Expiratory Volume in 1 Second for Participants With Asthma|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, prior surgery history, and regions as covariates.|Baseline, Week 52|Analysis was performed on a subset of participants which included all randomized participants with asthma and had available data for this outcome measure.|||liters||Standard Error|Least Squares Mean
2547790|NCT02898454|Secondary|Changed From Baseline at Week 24 in Forced Expiratory Volume in 1 Second (FEV1) for Participants With Asthma|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.|Baseline, Week 24|Analysis was performed on a subset of participants which included all randomized participants with asthma and had available data for this outcome measure. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.|||liters||Standard Error|Least Squares Mean
2547791|NCT02898454|Secondary|Total Systemic Corticosteroids Rescue Intake Duration: Average Duration Per Participant|Rescue treatment was defined as usage of SCS or NP surgery (actual or planned) during the treatment period. SCS Rescue intake duration was defined as the duration (in days) from start of SCS rescue medication till the end of SCS rescue treatment.|Baseline to Week 52|Analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||days||Standard Deviation|Mean
2547792|NCT02898454|Secondary|Mean Total Systemic Corticosteroids Rescue Dose Prescribed During Treatment Period|SCS included: betamethasone, deflazacort, dexamethasone, dexamethasone sodium phosphate, hydrocortisone, meprednisone, methylprednisolone, methylprednisolone sodium succinate, prednisolone, prednisolone sodium succinate, prednisone, stelamin, triamcinolone, and triamcinolone acetonide. For every participant, the total dose was calculated as (prescribed total daily dose*duration of SCS use). Then, mean of the total dose of 64 participants (placebo group), 17 participants (dupilumab 300 mg q2w then q4w) and 22 participants (dupilumab 300 mg q2w) was derived.|Baseline to Week 52|The analysis was performed on ITT population. Here, “overall number of participants analyzed” signifies participants evaluable for this outcome measure.|||milligrams||Standard Deviation|Mean
2547793|NCT02898454|Secondary|Change From Baseline at Week 52 in Rhinorrhea Daily Symptom Score|Rhinorrhea was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), where higher scores indicated more severe symptoms. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.|Baseline, Week 52|Analysis was performed on ITT population.|||score on a scale||Standard Error|Least Squares Mean
2547794|NCT02898454|Secondary|Change From Baseline at Week 24 in Rhinorrhea Daily Symptom Score|Rhinorrhea was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), where higher scores indicated more severe symptoms. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.|Baseline, Week 24|Analysis was performed on ITT population. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.|||score on a scale||Standard Error|Least Squares Mean
2547840|NCT02897115|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity|The Physician's Global Assessment of Disease Activity was assessed using an NRS from 0 (no disease activity) to 10 (severe disease activity).|Baseline, week 32, and week 52|Participants with available data at baseline and each time point|||score on a scale||Standard Deviation|Mean
2547797|NCT02898454|Secondary|Change From Baseline at Week 24 in Visual Analogue Scale (VAS) for Rhinosinusitis|"The VAS for rhinosinusitis was used to evaluate the total disease severity. The participants were asked to indicate on a 10 centimeters VAS the answer to the question, How troublesome are your symptoms of your rhinosinusitis? The range of the VAS was from 0 (not troublesome) to 10 (worse thinkable troublesome), where higher score indicated worse thinkable troublesome. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments."|Baseline, Week 24|Analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.|||centimeters||Standard Error|Least Squares Mean
2547798|NCT02898454|Secondary|Change From Baseline at Week 52 in Opacification of Sinuses Measured by Lund-Mackay Score|The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.|Baseline, Week 52|Analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547799|NCT02898454|Secondary|Change From Baseline at Week 52 in Severity of Decreased/Loss of Smell|The severity of decreased/loss of sense of smell was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), higher score indicated more severe symptoms. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.|Baseline, Week 52|Analysis was performed on ITT population.|||score on a scale||Standard Error|Least Squares Mean
2547800|NCT02898454|Secondary|Change From Baseline at Week 52 in the University of Pennsylvania Smell Identification Test Score|The UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia) to 40 (normal sense of smell), lower score indicated severe smell loss. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.|Baseline, Week 52|Analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547801|NCT02898454|Secondary|Change From Baseline at Week 52 in Total Symptom Score|The TSS was the sum of participant-assessed nasal symptom scores for NC/obstruction, decreased/loss of sense of smell, and rhinorrhea (anterior/posterior nasal discharge), each accessed on 0-3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms). Total score ranged from 0 (no symptoms) to 9 (severe symptoms). Higher score indicated more severe symptoms. Data was analyzed using a hybrid method of the WOCF and MI. The imputed completed data were analyzed by fitting an ANCOVA model with corresponding baseline value, treatment group, asthma/NSAID-ERD status, prior surgery history, and regions as covariates.|Baseline, Week 52|Analysis was performed on ITT population.|||score on a scale||Standard Error|Least Squares Mean
2547802|NCT02898454|Secondary|Rescue Treatment Use: Estimate of Percentage of Participants With Greater Than or Equal to (>=) 1 Event by Week 52 Obtained Using Kaplan-Meier Method|"Rescue treatment was defined as usage of systemic corticosteroids (SCS) or NP surgery (actual or planned) during the treatment period. Rescue treatment included:~SCS: betamethasone, deflazacort, dexamethasone, dexamethasone sodium phosphate, hydrocortisone, meprednisone, methylprednisolone, methylprednisolone sodium succinate, prednisolone, prednisolone sodium succinate, prednisone, stelamin, triamcinolone, and triamcinolone acetonide.~Sino-nasal surgery for nasal polyps when there was worsening of signs and/or symptoms during the study.~Estimate of percentage of participants with event by Week 52 was obtained using Kaplan-Meier method."|Baseline up to 52 weeks|Analysis was performed on ITT population. Data for this outcome measure was planned to be collected and analyzed for the pooled population of participants receiving Dupilumab.|||percentage of participants with event||95% Confidence Interval|Number
2547803|NCT02898454|Secondary|Change From Baseline at Week 52 in 22-item Sino-nasal Outcome Test Scores|The SNOT-22 is a validated questionnaire that was used to assess the impact of CRSwNP on HRQoL. It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview.|Baseline, Week 52|Analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547804|NCT02898454|Secondary|Change From Baseline at Week 52 in Nasal Congestion/Obstruction Symptom Severity Score|NC symptom severity was assessed by the participants on a daily basis from Visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview.|Baseline, Week 52|Analysis was performed on ITT population.|||score on a scale||Standard Error|Least Squares Mean
2547835|NCT02897115|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES)|The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at 13 entheses (sites where tendons or ligaments insert into the bone). All sites were scored as 0 (absent) or 1 (present). The MASES is the sum of all site scores (from 0 to 13).|Baseline, week 32, and week 52|Participants with available data at baseline and each time point|||score on a scale||Standard Deviation|Mean
2547805|NCT02898454|Secondary|Change From Baseline at Week 52 in Nasal Polyp Score|NPS was the sum of right and left nostril scores, as evaluated by means of nasal endoscopy. For each nostril, NPS was graded based on polyp size from 0 to 4 (0 = no polyps to 4 = large polyps causing complete obstruction of the inferior nasal cavity), with a lower score indicating smaller-sized polyps. Total NPS was the sum of right and left nostril scores and ranges from 0 (no polyp) to 8 (large polyp), with highest score representing more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. Data were analyzed using a hybrid method of the WOCF and MI. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview.|Baseline, Week 52|"Analysis was performed on ITT population. Here, overall number of participants analyzed= participants evaluable for this outcome measure."|||score on a scale||Standard Error|Least Squares Mean
2547806|NCT02898454|Secondary|Change From Baseline at Week 24 in 22-item Sino-nasal Outcome Test (SNOT-22) Scores|The SNOT-22 is a validated questionnaire was used to assess the impact of chronic rhinosinusitis phenotype with nasal polyps (CRSwNP) on health-related quality of life (HRQoL). It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.|Baseline, Week 24|Analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.|||score on a scale||Standard Error|Least Squares Mean
2547807|NCT02898454|Secondary|Change From Baseline at Week 24 in Severity of Decreased/Loss of Smell as Assessed by Participant Daily|The severity of decreased/loss of sense of smell was reported by the participants using a 0 to 3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms), higher score indicated more severe symptoms. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.|Baseline, Week 24|Analysis was performed on ITT population. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.|||score on a scale||Standard Error|Least Squares Mean
2547808|NCT02898454|Secondary|Change From Baseline at Week 24 in the University of Pennsylvania Smell Identification Test (UPSIT) Score|The UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia) to 40 (normal sense of smell), lower score indicated severe smell loss. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.|Baseline, Week 24|Analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.|||score on a scale||Standard Error|Least Squares Mean
2547809|NCT02898454|Secondary|Change From Baseline at Week 24 in Total Symptom Score (TSS)|The TSS was the sum of participant-assessed nasal symptom scores for NC/obstruction, decreased/loss of sense of smell, and rhinorrhea (anterior/posterior nasal discharge), each accessed on 0-3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms). Total score ranged from 0 (no symptoms) to 9 (severe symptoms). Higher score indicated more severe symptoms. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.|Baseline, Week 24|Analysis was performed on ITT population. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.|||score on a scale||Standard Error|Least Squares Mean
2547810|NCT02898454|Secondary|Change From Baseline at Week 24 in Opacification of Sinuses Measured by Lund Mackay (LMK) Score|The LMK scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score was the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. NOTE: For Japan regulatory submission only, this endpoint is not included as a secondary outcome measure and is instead one of the co-primary outcome measures. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.|Baseline, Week 24|Analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2547811|NCT02898454|Primary|Change From Baseline at Week 24 in Nasal Polyp Score|NPS: sum of right, left nostril scores, evaluated by nasal endoscopy. For each nostril, NPS was graded based on polyp size from 0 = no polyps to 4 = large polyps causing complete obstruction of inferior nasal cavity; lower score = smaller sized polyps. Total NPS: sum of right and left nostril scores, ranges from 0 (no polyps) to 8 (large polyps), higher score = more severe disease. NPS was assessed by centralized, blinded, independent review of the nasal endoscopy video recordings. LS means and SE were obtained from ANCOVA model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.|Baseline, Week 24|Analysis was performed on ITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.|||score on a scale||Standard Error|Least Squares Mean
2547836|NCT02897115|Secondary|Change From Baseline in Tender Joint Count|An assessment of 68 joints was performed by physical examination of each joint. The tender joint count is the number of joints assessed as tender (0 to 68).|Baseline, week 32, and week 52|Participants with available data at baseline and each time point|||tender joints||Standard Deviation|Mean
2547812|NCT02898454|Primary|Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score|NC symptom severity was assessed by the participants on a daily basis from visit 1 and throughout the study using an e-diary on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicated more severity. Least squares (LS) means and standard error (SE) were obtained from Analysis of covariance (ANCOVA) model described in Statistical Analysis Overview. All participants randomized to receive Dupilumab had been on 300 mg q2w regimen until Week 24 and analyzed as a pooled population for Week 24 assessments.|Baseline, Week 24|The analysis was performed on intent-to-treat (ITT) population which included all randomized participants who were analyzed according to the treatment group allocated by randomization. Data for this outcome measure was planned to be analyzed for the combined population of participants who received Dupilumab.|||score on a scale||Standard Error|Least Squares Mean
2547813|NCT02898116|Secondary|Number of Subjects With Immune-related Tumor Response at the Last Assessment|Immune-related tumor response was evaluated by computed tomography at Baseline, every 2 cycles, and at the end of the study. Tumor response was designated according to the immune-related Response Criteria (irRC) (Wolchok et al. Clin Cancer Res 2009;15:7412-20) into the following categories: immune-related complete response (irCR) requires disappearance of all lesions in two consecutive observations not less than 4 weeks apart; immune-related partial response (irPR) requires ≥ 50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart; immune-related stable disease (irSD) is assigned when neither a 50% decrease from baseline tumor burden nor a 25% increase in tumor burden from nadir can be established; immune-related progressive disease (irPD) requires a ≥ 25% increase from nadir in tumor burden at any single time point in two consecutive observations at least 4 weeks apart.|up to 3 months|All enrolled subjects|||Participants|||Count of Participants
2547814|NCT02898116|Secondary|Number of Subjects With Best Overall Tumor Response at the Last Assessment|Tumor response was evaluated using computed tomography and categorized according to the Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) at Baseline, every 2 cycles, and at the end of the study. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|up to 3 months|All enrolled subjects|||Participants|||Count of Participants
2547815|NCT02898116|Primary|Number of Subjects With Treatment-emergent Adverse Events|Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the end of the study period. Dose-limiting toxicity (DLT) during the Run-in Period was defined as ≥ Grade 2 rash or other toxicity requiring discontinuation of ensartinib dosing.|up to 3 months|All enrolled subjects|||participants|||Number
2547816|NCT02897349|Secondary|Percentage of Participants With Any Severe Hypoglycaemic AE|Incidence of severe hypoglycaemic events (requiring active assistance by another person, or fatal). Severe hypoglycaemic AE = hypoglycaemic event requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.|24 weeks|TS|||Percentage of Participants|||Number
2547817|NCT02897349|Secondary|Percentage of Participants With Any Investigator-defined Hypoglycaemic Adverse Event (AE) With Plasma Glucose (PG) ≤70 mg/dL|Incidence of investigator-reported hypoglycaemic events confirmed by a measured blood glucose ≤70 mg/dL (≤3.9 Millimoles Per Litre (mmol/L)). Severe hypoglycaemic AE = hypoglycaemic event requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.|24 weeks|Treated set (TS) : The TS consisted of all patients treated with at least one dose of study drug.|||Percentage of Participants|||Number
2547818|NCT02897349|Secondary|Percentage of Participants With HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment|Percentage of participants with HbA1c lowering by at least 0.5% after 24 weeks of treatment.|24 weeks|FAS (NCF)|||Percentage of participants|||Number
2547819|NCT02897349|Secondary|Percentage of Participants With HbA1c on Treatment < 6.5% After 24 Weeks of Treatment|Percentage of participants with HbA1c on treatment < 6.5% after 24 weeks of treatment. Participants with baseline HbA1c <6.5% were excluded from the analysis.|24 weeks|FAS (NCF)|||Percentage of participants|||Number
2547820|NCT02897349|Secondary|Percentage of Participants With HbA1c on Treatment <7.0 Percentage (%) After 24 Weeks of Treatment|Percentage of participants with HbA1c on treatment <7.0 percentage (%) after 24 weeks of treatment. Participants with baseline HbA1c <7.0% were excluded from the analysis.|24 weeks|Full analysis set (FAS) Non-completers considered as failure (NCF)|||Percentage of participants|||Number
2547821|NCT02897349|Secondary|Change From Baseline in 2-hour (2-h) Postprandial Plasma Glucose (PPG) After 24 Weeks of Treatment|Change from baseline in 2-hour (2-h) postprandial plasma glucose (PPG) after 24 weeks of treatment.|Baseline and week 24|Meal tolerance test (MTT) (OC) set: MTT-set consisted all patients of the FAS with a valid MTT at baseline and at the end of the study. An MTT was considered valid if it had a valid FPG and a valid 2-h PPG value.|||mg/dL||Standard Error|Least Squares Mean
2547822|NCT02897349|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment|Change from baseline in Fasting plasma glucose (FPG) after 24 weeks of treatment.|Baseline and week 24|FAS (OC)|||Milligram/Decilitre (mg/dL)||Standard Error|Least Squares Mean
2547823|NCT02897349|Primary|Percentage Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment|Percentage change from baseline, that is, [[(HbA1c after 24 weeks of treatment) - (HbA1c at baseline)] / (HbA1c at baseline)] *100%, where baseline refers to the last observation prior to the start of randomised study drug, including the observation prior to the placebo run-in.|Baseline and week 24|Full analysis set (FAS) observed cases (OC): The FAS consisted of all patients randomised in the TS who had a baseline HbA1c value and at least one on-treatment HbA1c value. The FAS was the basis for the intention-to-treat (ITT) analysis.|||Percentage change||Standard Error|Least Squares Mean
2547837|NCT02897115|Secondary|Change From Baseline in Swollen Joint Count|An assessment of 66 joints was performed by physical examination of each joint. The swollen joint count is the number of joints assessed as swollen (0 to 66).|Baseline, week 32, and week 52|Participants with available data at baseline and each time point|||swollen joints||Standard Deviation|Mean
2547824|NCT02897141|Secondary|Health-IT Usability Evaluation Scale (Health-ITUES)|Health Information Technology Usability Evaluation Scale (Health-ITUES) was used to measure usability. Health-ITUES consists of 20 items rated on a 5-point Likert scale from strongly disagree (score of 1) to strongly agree (score of 5) measuring actual usage, intention to use, satisfaction, perceived usefulness, perceived ease of use, perceived performance speed, learnability, competency, flexibility/customizability, memorability, error prevention, information needs, and other outcomes. A higher score (5) indicates higher usability. Overall score was calculated as the mean score from the score for quality of life, perceived usefulness, perceived ease of use, and user control.|12 weeks||||score on a scale||Standard Deviation|Mean
2547825|NCT02897141|Secondary|Medication Adherence|"Medication adherence was calculated by two scales: the Center for Adherence Support Evaluation (CASE) Adherence Index and the Visual Analogue Scale (VAS). The CASE Adherence Index consists of the composite scores of three questions evaluating self-reported measures of adherence. The minimum score on this scale is 3 while the maximum score on this scale is 16, with higher scores indicating better outcome. Scores greater than 10 indicate good adherence, while scores less than or equal to 10 indicate poor adherence.~The VAS asks subjects to indicate a point on a line that shows their best guess about how much of each drug they have taken from a scale of 0% to 100% in which 0% means they have taken no drug, 50% means they have taken half their drugs, and 100% means they have taken every single dose. Consequently, a higher score (100%) indicates"|12 weeks||||score on a scale||Standard Deviation|Mean
2547826|NCT02897141|Secondary|Engagement With Healthcare Provider|Engagement with Health Care Provide scale is a 13-item scale in which subjects rate their interactions with their health care providers on a four-point scale with 1=always true and 4=never true in which a lower score indicates a better outcome. The scores are then collated to an aggregate score where the minimum value = 13 and the maximum value = 52. A low score indicates greater provider engagement, where as higher scores indicate lower provider engagement (less favorable outcome). The difference in scores at baseline and follow-up at three months was calculated within both the intervention and control groups, and the difference was then taken between the resulting means of those scores.|Baseline and 12 weeks||||score on a scale||Standard Deviation|Mean
2547827|NCT02897141|Secondary|Patient-Reported Outcomes Measurement Information System (PROMIS)-29|The PROMIS-29 includes seven health related quality of life domains on a 5-point scale from a score of 1 to 5 and the pain domain has two subdomains (interference and intensity) where pain intensity is assessed using a single 11-point numeric rating scale anchored between no pain (0) and worse imaginable pain (10). Raw scores are transformed using the T-score metric based on the item response theory calibrations in which scores have a mean of 50 and standard deviation of 10 for the general population in the US. T-scores can be estimated using the scoring tables listed in the PROMIS manuals. A higher PROMIS T-score implies more of the concept being measured; for instance, a higher PROMIS score on physical function indicates better functioning, whereas a higher score on depression indicates a greater severity of depression.|12 weeks||||T-score||Standard Deviation|Mean
2547828|NCT02897141|Secondary|Change in Quality of Life -- RAND-36|36-Item Short Form Survey (RAND-36) is a widely-used 36-item tool to measure health-related quality of life, where each item in the scale is scored as 0, 25, 50, 75, or 100. Scoring is a two-step process. First, precoded numeric values are recoded per the scoring key so that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores, where a lower score may indicate a better outcome for some of the scales, while it may indicate a better outcome for others.|Baseline and 12 weeks||||score on a scale||Standard Deviation|Mean
2547829|NCT02897141|Primary|Change in Symptom Status From Baseline to Week 12|"Change in Symptom Status calculates the difference in symptom scores between the intervention and control groups at baseline versus follow-up after 12 weeks. Symptom scores were determined using the Revised Sign and Symptom Check-List for HIV (SSC-HIVrev), where participants who reported experiencing any one of the 13 symptoms in the past 7 days were asked how much it bothered them (a little bit, somewhat, quite a bit, or very much). Instances where the symptom did not bother the individual were coded as 0 whereas instances where the symptom bothered the individual any amount were recoded as 1. The overall difference between groups at baseline and after 12 weeks (difference of differences) falls within a range of -1 to 1, where lower numbers indicate the symptom bothered the person less, while higher numbers indicate it bothered them more. With the Difference Between Groups, a more negative score (closer to -1) represents a better outcome."|Baseline and 12 weeks||||score on a scale||Standard Error|Mean
2547830|NCT02897115|Secondary|Number of Participants With New Onset Anterior Uveitis|Anterior uveitis is an inflammation of the middle layer of the eye. which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body.|Up to Week 52||||Participants|||Count of Participants
2547831|NCT02897115|Secondary|Change From Baseline in Linear Bath Ankylosing Spondylitis Metrology Index (BASMIlin)|The linear Bath Ankylosing Spondylitis Metrology Index (BASMIlin) is a composite score based on 5 direct measurements of spinal mobility: lateral lumbar flexion, tragus‐to‐wall distance, lumbar flexion, intermalleolar distance, and cervical rotation angle. The total score ranges from 0 to 10, where higher scores indicate more limited mobility.|Baseline, week 32, and week 52|Participants with available data at baseline and each time point|||score on a scale||Standard Deviation|Mean
2547832|NCT02897115|Secondary|Change From Baseline in C-reactive Protein (CRP)|CRP is an acute phase reactant is a blood test marker for inflammation in the body. CRP levels rise in response to inflammation.|Baseline, week 32, and week 52|Participants with available data at baseline and each time point|||mg/L||Standard Deviation|Mean
2547833|NCT02897115|Secondary|Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)|Erythrocyte sedimentation rate measures the rate of fall (sedimentation) of erythrocytes (red blood cells) in a sample of blood that has been placed into a tall, thin, vertical tube as an indirect measure of the degree of inflammation present in the body.|Baseline, week 32, and week 52|Participants with available data at baseline and each time point|||mm/hour||Standard Deviation|Mean
2547838|NCT02897115|Secondary|Change From Baseline in Patient's Global Assessment of Pain|The Patient's Global Assessment of Pain was assessed on a NRS from 0 (no pain) to 10 (pain as bad as it could be).|Baseline, week 32, and week 52|Participants with available data at baseline and each time point|||score on a scale||Standard Deviation|Mean
2547841|NCT02897115|Secondary|Change From Baseline in Active Inflammation of the Sacroiliac Joints and Spine|Active inflammation of the sacroiliac (SI) joints as well as the cervical, thoracic and lumbar regions of the spine was assessed using magnetic resonance imaging (MRI). Images were scored by a central reader according to the Berlin MRI Score on a grading scale from 0 to 3, where Grade 0 indicates no active inflammation and Grade 3 indicates > 66% inflammation of the sacroiliac joints or > 50% active inflammation in the spine.|Baseline and week 52|The study terminated early due to slow enrollment and no data were collected.||||||
2547842|NCT02897115|Secondary|Percentage of Participants Achieving ASAS Partial Remission|"ASAS partial remission is defined as an absolute score of ≤ 2 units on a 0 to 10 scale for each of the four following domains:~Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Week 32 and week 52|Participants with available data at each time point|||percentage of participants|||Number
2547843|NCT02897115|Secondary|Percentage of Participants Achieving an ASAS 40 Response|"ASAS40 response was defined as improvement of ≥ 40% relative to baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline, week 32, and week 52|Participants with available data at baseline and each time point|||percentage of participants|||Number
2547844|NCT02897115|Secondary|Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response|"ASAS20 response was defined as improvement of ≥ 20% relative to baseline and absolute improvement of ≥ 1 unit (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 unit) in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline, week 32, and week 52|Participants with available data at baseline and each time point|||percentage of participants|||Number
2547845|NCT02897115|Secondary|Percentage of Participants With ASDAS Very High Disease Activity|"ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for inactive disease; ≥ 1.3 to < 2.1 for moderate disease activity; ≥ 2.1 to ≤ 3.5 for high disease activity and > 3.5 for very high disease activity. The percentage of participants with very high disease activity (defined as an ASDAS > 3.5) calculated using CRP is reported"|Week 32 and week 52|Participants with available data at each time point|||percentage of participants|||Number
2547846|NCT02897115|Secondary|Percentage of Participants With ASDAS High Disease Activity|"ASDAS high disease activity is defined as an ASDAS ≥ 2.1 to < 3.5. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for inactive disease; ≥ 1.3 to < 2.1 for moderate disease activity; ≥ 2.1 to ≤ 3.5 for high disease activity and > 3.5 for very high disease activity. The percentage of participants with high disease activity (defined as an ASDAS ≥ 2.1 to < 3.5) calculated using CRP is reported."|Week 32 and week 52|Participants with available data at each time point|||percentage of participants|||Number
2547847|NCT02897115|Secondary|Percentage of Participants With ASDAS Moderate Disease Activity|"ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for inactive disease; ≥ 1.3 to < 2.1 for moderate disease activity; ≥ 2.1 to ≤ 3.5 for high disease activity and > 3.5 for very high disease activity. The percentage of participants with ASDAS moderate disease activity (defined as an ASDAS ≥ 1.3 to < 2.1) calculated using CRP is reported."|Week 32 and week 52|Participants with available data at each time point|||percentage of participants|||Number
2547856|NCT02897115|Secondary|Change From Baseline in Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI)|The ASAS HI measures functioning and health across 17 aspects of health in patients with AS, including pain, emotional functions, sleep, sexual function, mobility, self care, and community life. The ASAS HI consists of 17 questions, each answered by the participant as agree (1) or disagree (0). The responses to the 17 dichotomous items are summed up to give a total score ranging from 0 to 17, with a lower score indicating a better and a higher score indicating an inferior health status.|Baseline, week 32, and week 52|Participants with available data at baseline and each time point|||score on a scale||Standard Deviation|Mean
2547848|NCT02897115|Secondary|Percentage of Participants With ASDAS Low Disease Activity|"ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for inactive disease; ≥ 1.3 to < 2.1 for moderate disease activity; ≥ 2.1 to ≤ 3.5 for high disease activity and > 3.5 for very high disease activity. The percentage of participants with ASDAS low disease activity (defined as ASDAS < 2.1) calculated using CRP is reported."|Week 32 and week 52|Participants with available data at each time point|||percentage of participants|||Number
2547849|NCT02897115|Secondary|Percentage of Participants With ASDAS Inactive Disease at Week 52|"ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for inactive disease; ≥ 1.3 to < 2.1 for moderate disease activity; ≥ 2.1 to ≤ 3.5 for high disease activity and > 3.5 for very high disease activity. The percentage of participants with ASDAS inactive disease (defined as ASDAS < 1.3) calculated using CRP is reported."|Week 52|Participants with available data at week 52|||percentage of participants|||Number
2547850|NCT02897115|Secondary|Percentage of Participants Achieving ASDAS(CRP) Clinically Important Improvement|"ASDAS clinically important improvement is defined as a change from baseline ≤ -1.1.~ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for inactive disease; ≥ 1.3 to < 2.1 for moderate disease activity; ≥ 2.1 to ≤ 3.5 for high disease activity and > 3.5 for very high disease activity. The percentage of participants with clinically important improvement in ASDAS calculated using CRP is reported."|Baseline, week 32, and week 52|Participants with available data at baseline and each time point|||percentage of participants|||Number
2547851|NCT02897115|Secondary|Percentage of Participants Achieving ASDAS(CRP) Major Improvement|"ASDAS Major Improvement is defined as a change from baseline ≤ -2.0. ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for inactive disease; ≥ 1.3 to < 2.1 for moderate disease activity; ≥ 2.1 to ≤ 3.5 for high disease activity and > 3.5 for very high disease activity. The percentage of participants with major improvement in ASDAS calculated using CRP is reported."|Baseline, week 32, and week 52|Participants with available data at baseline and each time point|||percentage of participants|||Number
2547852|NCT02897115|Secondary|Change From Baseline in ASDAS(CRP)|"ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (CRP or ESR) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for inactive disease; ≥ 1.3 to < 2.1 for moderate disease activity; ≥ 2.1 to ≤ 3.5 for high disease activity and > 3.5 for very high disease activity. Change from baseline in ASDAS calculated using CRP is reported."|Baseline, week 32, and week 52|Participants with available data at baseline and each time point|||score on a scale||Standard Deviation|Mean
2547853|NCT02897115|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)|The Bath Ankylosing Spondylitis Functional Index (BASFI) is a validated index to determine the degree of functional limitation in patients with AS. BASFI consists of 10 questions assessing participants' ability to perform activities, on a numeric rating scale (NRS) ranging from 0 (easy to perform an activity) to 10 (impossible to perform an activity). The overall score is the mean of the 10 items and ranges from 0 (best) to 10 (worst).|Baseline, week 32, and week 52|Participants with available data at baseline and each time point|||score on a scale||Standard Deviation|Mean
2547854|NCT02897115|Secondary|Percentage of Participants Achieving a BASDAI 50 Response|"The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.~A BASDAI 50 response is defined as improvement of 50% or more from baseline in BASDAI score."|Baseline, week 32, and week 52|Participants with available data at baseline and each time point|||percentage of participants|||Number
2547855|NCT02897115|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index|The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 where lower scores indicate less disease activity.|Baseline, week 32, and week 52|Participants with available data at baseline and each time point|||score on a scale||Standard Deviation|Mean
2547879|NCT02896595|Secondary|Patient Satisfaction|patients will be given an survey by study personnel prior to discharge from the hospital; survey will be conducted in person by study personnel|Up to six months|Not all participant provided survey data|||Participants|||Count of Participants
2547857|NCT02897115|Secondary|Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Total Activity Impairment|The Work Productivity and Activity Impairment (WPAI) axSpA is an axSpA specific questionnaire consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), overall work impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. A negative change from baseline indicates improvement.|Baseline, week 32, and week 52|Participants with available data at baseline and each time point.|||percent impairment||Standard Deviation|Mean
2547858|NCT02897115|Secondary|Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Total Work Productivity Impairment|The Work Productivity and Activity Impairment (WPAI) axSpA is an axSpA specific questionnaire consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), overall work impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. A negative change from baseline indicates improvement.|Baseline, week 32, and week 52|Participants who were employed and with available data at baseline and each time point.|||percent impairment||Standard Deviation|Mean
2547859|NCT02897115|Secondary|Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Absenteeism|The Work Productivity and Activity Impairment (WPAI) axSpA is an axSpA specific questionnaire consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), overall work impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. A negative change from baseline indicates improvement.|Baseline, week 32, and week 52|Participants who were employed and with available data at baseline and each time point.|||percent impairment||Standard Deviation|Mean
2547860|NCT02897115|Secondary|Change From Baseline in Work Productivity and Activity Impairment - Axial Spondyloarthritis (WPAI-axSpA): Presenteeism|The Work Productivity and Activity Impairment (WPAI) axSpA is an axSpA specific questionnaire consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), overall work impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. A negative change from baseline indicates improvement.|Baseline, week 32, and week 52|Participants who were employed and with available data at baseline and each time point.|||percent impairment||Standard Deviation|Mean
2547861|NCT02897115|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire|The EQ-5D-3L is a health state utility instrument that evaluates preference for health status (utility). The 5 items in the EQ-5D-3L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 3 levels of severity (1: indicating no problem, 2: indicating some/moderate problems, 3: indicating extreme problems). A single preference-weighted health utility index score was calculated by applying country-specific weights, with scores ranging from approximately 0 (death) to 1 (full health).|Baseline, week 32, and week 52|Participants with available data at baseline and at each time point|||units on a scale||Standard Deviation|Mean
2547862|NCT02897115|Primary|Percentage of Participants With an Ankylosing Spondylitis Disease Activity Score (ASDAS) of Inactive Disease at Week 32|"ASDAS is a composite disease activity outcome measure which combines patient reported back pain, duration of morning stiffness, patient global assessment of disease activity, patient assessment of peripheral joint pain and swelling and an acute phase reactant (C-reactive protein [CRP] or erythrocyte sedimentation rate [ESR]) as an objective measure of inflammation. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS are: < 1.3 for inactive disease; ≥ 1.3 to < 2.1 for moderate disease activity; ≥ 2.1 to ≤ 3.5 for high disease activity and > 3.5 for very high disease activity. The percentage of participants with ASDAS inactive disease (defined as ASDAS < 1.3) calculated using CRP is reported."|Week 32|Participants with available data at week 32|||percentage of participants|||Number
2547863|NCT02896907|Secondary|Change in Quality of Life as Defined by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30|Change in quality of life over the six measurement times will be modeled using mixed effects linear regression to account for correlation among repeated measurements from the same subjects. Average change in QoL from baseline to follow-up will be computed.|Baseline to up to 28 days after the last treatment||||score on a scale||Standard Deviation|Mean
2547864|NCT02896907|Primary|Number of Participants With Adverse Events as Determined by CTCAE Version 4.03|After 4 patients are enrolled on the study and receive at least one dose of intravenous ascorbic acid, the data will be reviewed. If 2 out of the 4 cannot complete 2 courses of FOLFIRINOX then the study will be halted.|Up to 28 days after the last treatment||||Participants|||Count of Participants
2547880|NCT02896595|Secondary|Aspiration Events|aspiration events as noted in the anesthesia, PACU and post procedure notes would be documented|Up to 7 days||||Events|||Number
2547881|NCT02896595|Secondary|Atrial Fibrillation Recurrence|defined as recurrence of paroxysmal atrial fibrillation recurring at any time after 6 weeks past the day of procedure. As standard of care these patients are followed up with Holter monitoring for a period of 6 months. Holter monitoring will be done for 48 hour time periods immediately post-procedure, 2 weeks, 6 weeks, 4 months and 6 months post procedure as is standard of care|From end of procedure to six month followup holter monitor||||incidents|||Number
2547882|NCT02896595|Secondary|Post-procedure Emesis|Measured by number of times patient has emesis during post-procedure time period|Up to 7 days|Data not collected for this variable||||||
2547883|NCT02896595|Secondary|Post-procedure Nausea|Measured by number of doses of antiemetics given in the post-procedure time period mg of Zofran (ondanesteron) given post-operatively|Up to 7 days||||Milligrams||Standard Error|Mean
2547865|NCT02896855|Secondary|Change From Baseline to Maximum On-Treatment Decrease in LVEF at Any Point During the Study|The baseline left ventricular ejection fraction (LVEF) and change from baseline to the maximum on-treatment decrease in LVEF at any point during the study are reported here. LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction. LVEF was calculated using the modified Simpson method and must have been ≥55% at baseline as determined by the local facility before a participant could be enrolled in the study. The investigator decided which method of LVEF assessment (ECHO [preferred] or MUGA scan) would be used for each participant at baseline, and the same method should have been used throughout the study, to the extent possible. At the primary completion date, the mean (standard deviation) duration of time that participants were on study in Arms A and B were 57.74 (19.14) weeks and 59.46 (16.80) weeks, respectively.|Baseline and every 9 weeks from date of randomization until treatment discontinuation (up to approximately 3 years)|Safety population, which includes participants who received at least one dose of any study drug. Number analyzed indicates participants with a baseline LVEF measurement and at least one post-baseline LVEF measurement, respectively.|||percentage points of LVEF||Standard Deviation|Mean
2547866|NCT02896855|Secondary|Change From Baseline in LVEF Over Time, as Determined Using ECHO or MUGA Scan|Here, we report the change from baseline in LVEF over time. Left ventricular ejection fraction (LVEF) is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction. LVEF was calculated using the modified Simpson method and must have been ≥55% at baseline as determined by the local facility before a participant could be enrolled in the study. The investigator must have decided which method of LVEF assessment (ECHO [preferred] or MUGA scan) would be used for each participant at baseline, and the same method should have been used throughout the study, to the extent possible. At the primary completion date, the mean (standard deviation) duration of time that participants were on study in Arms A and B were 57.74 (19.14) weeks and 59.46 (16.80) weeks, respectively.|Baseline, every 9 weeks from the date of randomization until the treatment discontinuation visit, then every 6 months for the first year and annually thereafter for up to 3 years|Safety population, which includes participants who received at least one dose of any study drug. Number analyzed indicates the number of participants with a post-baseline LVEF measurement at each time point.|||percentage points of LVEF||95% Confidence Interval|Mean
2547867|NCT02896855|Secondary|Number of Participants With an Asymptomatic Left Ventricular Ejection Fraction (LVEF) Event, as Determined Using ECHO or MUGA Scan|"An asymptomatic LVEF event is reported as an adverse event of ejection fraction decreased and is defined as either of the following: an absolute decrease in LVEF of ≥10 percentage points from baseline to an LVEF of <50%; or an asymptomatic decrease in LVEF requiring treatment or leading to discontinuation of pertuzumab (or placebo) and trastuzumab. At the primary completion date, the mean (standard deviation) duration of time that participants were on study in Arms A and B were 57.74 (19.14) weeks and 59.46 (16.80) weeks, respectively."|Baseline, every 9 weeks from the date of randomization until the treatment discontinuation visit, then every 6 months for the first year and annually thereafter for up to 3 years|Safety population, which includes participants who received at least one dose of any study drug.|||Participants|||Count of Participants
2547868|NCT02896855|Secondary|Number of Participants With Symptomatic Left Ventricular Systolic Dysfunction (LVSD), as Determined Using Echocardiography (ECHO) or Multiple-Gated Acquisition (MUGA) Scan|"The number of participants with symptomatic left ventricular systolic dysfunction (LVSD) at any time during the study, as determined using echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan, were summarized by treatment arm. Symptomatic LVSD was evaluated according to NCI CTCAE v4.0 (for heart failure) and the New York Heart Association (NYHA) classification. At the primary completion date, the mean (standard deviation) duration of time that participants were on study in Arms A and B were 57.74 (19.14) weeks and 59.46 (16.80) weeks, respectively."|Baseline, every 9 weeks from the date of randomization until the treatment discontinuation visit, then every 6 months for the first year and annually thereafter for up to 3 years|Safety population, which includes participants who received at least one dose of any study drug.|||Participants|||Count of Participants
2547869|NCT02896855|Secondary|Number of Participants With at Least One Adverse Event Leading to Withdrawal From Any Treatment|At the primary completion date, the mean (standard deviation) duration of time that participants were on study in Arms A and B were 57.74 (19.14) weeks and 59.46 (16.80) weeks, respectively.|From Baseline up to 3 years after treatment discontinuation|Safety population, which includes participants who received at least one dose of any study drug.|||Participants|||Count of Participants
2547870|NCT02896855|Secondary|Number of Participants With at Least One Grade ≥3 Adverse Event|The adverse event severity grading scale for the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0) was used for assessing the severity of adverse events. At the primary completion date, the mean (standard deviation) duration of time that participants were on study in Arms A and B were 57.74 (19.14) weeks and 59.46 (16.80) weeks, respectively.|From Baseline up to 3 years after treatment discontinuation|Safety population, which includes participants who received at least one dose of any study drug.|||Participants|||Count of Participants
2547871|NCT02896855|Secondary|Number of Participants With at Least One Adverse Event|The number of participants experiencing at least one adverse event, including all non-serious and serious adverse events, is reported here. At the primary completion date, the mean (standard deviation) duration of time that participants were on study in Arms A and B were 57.74 (19.14) weeks and 59.46 (16.80) weeks, respectively.|From Baseline up to 3 years after treatment discontinuation|Safety population, which includes participants who received at least one dose of any study drug.|||Participants|||Count of Participants
2547884|NCT02896595|Secondary|Airway Trauma|Any noted trauma in the anesthesia or post-procedure notes, including damage to lips/teeth, laryngospasm, need for reintubation post procedure|Up to 7 days||||Incidents|||Number
2547885|NCT02896595|Secondary|Electrophysiology Parameters|left ventricular ejection fraction|Up to 270 minutes|Data was not collected||||||
2547886|NCT02896595|Secondary|Electrophysiology Parameters|size of left atrium (mm)|Up to 270 minutes|Data was not collected||||||
2547887|NCT02896595|Secondary|Electrophysiology Parameters|duration of paroxysmal atrial fibrillation prior to procedure|Up to 270 minutes|Data was not collected||||||
2547888|NCT02896595|Secondary|Intraprocedure Pressor/Ionotrope/Chronotrope Requirements|total measured amounts of all pressors/ionotropes and chronotropes administered intraoperatively|Up to 270 minutes||||milligrams||Standard Error|Mean
2547872|NCT02896855|Secondary|Duration of Objective Response, as Determined by the Investigator Using RECIST v1.1|Duration of objective response was defined as the time from the first occurrence of a documented objective response (complete response [CR] or partial response [PR]) to the time of disease progression, as determined by the investigator using RECIST v1.1, or death from any cause within 18 weeks after the last tumor assessment, whichever occurred first. As per RECIST v1.1, CR is defined as the disappearance of all target lesions, and PR is defined as at least a 30% decrease in the sum of diameters of target lesions. The Kaplan-Meier approach was used to estimate median duration of objective response. Data for participants who did not have an event were censored at the time of the last tumor assessment (if no tumor assessments were performed after baseline visit, at randomization plus 1 day). At the primary completion date, mean (standard deviation) duration of time on study in Arms A and B were 57.74 (19.14) weeks and 59.46 (16.80) weeks, respectively.|From date of first occurrence of documented objective response to date of progressive disease or date of death from any cause within 18 weeks after the last tumor assessment, whichever occurs first (up to approximately 3 years)|Only participants with measurable disease at baseline who achieved an objective response during the study were included in the analysis.|||months||95% Confidence Interval|Median
2547873|NCT02896855|Secondary|Percentage of Participants With Measurable Disease at Baseline Who Achieved an Objective Response (Complete or Partial Response), as Determined by the Investigator Using RECIST v1.1|An objective response was defined as a complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1. As per RECIST v1.1, CR is defined as the disappearance of all target lesions, and PR is defined as at least a 30% decrease in the sum of diameters of target lesions. Also per RECIST v1.1, stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum on study; PD is defined as a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm, and the appearance of new lesions. The same assessment technique must be used throughout the study for evaluating a particular lesion, and the same investigator should assess all tumor responses for each participant. Participants without a post-baseline tumor assessment were considered non-responders.|At Baseline and every 9 weeks from date of randomization until disease progression or death, whichever occurs first (up to approximately 3 years)|Only participants with measurable disease at baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2547874|NCT02896855|Secondary|Percentage of Participants With 1 Year of Overall Survival|Overall survival (OS) was defined as the time from randomization to death from any cause. The Kaplan-Meier approach was used to estimate the percentage of participants with 1 year of OS. Participants who were alive or lost to follow-up at the time of the analysis were censored at the date they were last known to be alive. Participants with no post-baseline information were censored at the time of randomization plus 1 day. At the primary completion date, mean (standard deviation) duration of time on study in Arms A and B were 57.74 (19.14) weeks and 59.46 (16.80) weeks, respectively.|From date of randomization until the date of death from any cause (up to 1 year)|ITT population|||estimate of percentage of participants||95% Confidence Interval|Number
2547875|NCT02896855|Secondary|Overall Survival|Overall survival (OS) was defined as the time from randomization to death from any cause. The Kaplan-Meier approach was used to estimate median OS for each treatment arm. Participants who were alive or lost to follow-up at the time of the analysis were censored at the date they were last known to be alive. Participants with no post-baseline information were censored at the time of randomization plus 1 day. At the primary completion date, mean (standard deviation) duration of time on study in Arms A and B were 57.74 (19.14) weeks and 59.46 (16.80) weeks, respectively.|From date of randomization until the date of death from any cause (up to approximately 3 years)|ITT population; At the primary completion date, the median duration of OS had not been reached and OS data was not considered mature due to the few number of events reported. Survival follow-up is ongoing, and results will be reported upon study completion.|||months||95% Confidence Interval|Median
2547876|NCT02896855|Primary|Percentage of Participants With 1 Year of Progression-Free Survival, as Determined by the Investigator Using RECIST v1.1|Progression-free survival (PFS) was defined as the time from randomization to first occurrence of progressive disease (PD), as determined by the investigator using RECIST v1.1, or death from any cause within 18 weeks after the last tumor assessment, whichever occurred first. As per RECIST v1.1, PD is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm, and the appearance of new lesions. The Kaplan-Meier approach was used to estimate the percentage of participants with 1 year of PFS for each treatment arm. Data for participants who did not have a PFS event were censored at the time of the last tumor assessment (if no tumor assessments performed after baseline visit, at randomization plus 1 day). At the primary completion date, mean (standard deviation) duration of time on study in Arms A and B were 57.74 (19.14) and 59.46 (16.80) weeks, respectively.|From date of randomization until date of first documented PD or date of death from any cause within 18 weeks after the last tumor assessment, whichever occurs first (up to 1 year)|ITT population|||estimate of percentage of participants||95% Confidence Interval|Number
2547877|NCT02896855|Primary|Progression-Free Survival, as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|Progression-free survival (PFS) was defined as the time from randomization to first occurrence of progressive disease (PD), as determined by the investigator using RECIST v1.1, or death from any cause within 18 weeks after the last tumor assessment, whichever occurred first. As per RECIST v1.1, PD is defined as a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeters (mm), and the appearance of new lesions. The Kaplan-Meier approach was used to estimate median PFS for each treatment arm. Data for participants who did not have a PFS event were censored at the time of the last tumor assessment (if no tumor assessments performed after baseline, at randomization plus 1 day). At the primary completion date, mean (standard deviation) duration of time on study in Arms A and B were 57.74 (19.14) weeks and 59.46 (16.80) weeks, respectively.|From date of randomization until date of first documented PD or date of death from any cause within 18 weeks after the last tumor assessment, whichever occurs first (up to approximately 3 years)|ITT population|||months||95% Confidence Interval|Median
2547878|NCT02896595|Secondary|Cost Analysis|an analysis of cost to patient as well as overall hospital costs will be conducted|Up to six months|Data not collected||||||
2547889|NCT02896595|Secondary|Intraoperative Hemodynamics|diastolic blood pressure|Up to 270 minutes|Data was not collected||||||
2547905|NCT02896296|Primary|Participants With Treatment-emergent Adverse Events (TEAEs) Pertaining to Laboratory Test Values|TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. The number of participants with TEAEs specific to laboratory tests are summarized.|Day 1 up to Week 25|Safety population|||Participants|||Count of Participants
2547906|NCT02896296|Primary|Percentage Change From Baseline to Week 25 in Vital Signs|"Vital signs include:~systolic blood pressure (mmHg)~diastolic blood pressure (mmHg)~respiratory rate (breaths/minute)~pulse oximetry (%)~pulse rate (beats/min)~temperature (C)"|Day 1, Week 25|Safety analysis set. Participants with both baseline and Week 25 data are included.|||percentage change from baseline||Standard Deviation|Mean
2547907|NCT02896296|Primary|Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period|TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical or surgical intervention to prevent one of the outcomes listed in this definition.|Day 1 up to Week 29|Safety analysis set|||Participants|||Count of Participants
2547908|NCT02895347|Primary|Amount of Time to Achieve Proficiency|time, measured in minutes, it took each participant in the intervention group to achieve surgical proficiency on the robotic simulator.|assessed after the orientation and prior to the three week date for the final suturing assessment||||minutes||Full Range|Mean
2547909|NCT02895347|Primary|Amount Time to Suture|time, measured in minutes, it took each participant to perform the suturing activity|Three weeks after orientation||||minutes||Standard Deviation|Mean
2547910|NCT02895347|Primary|Global Evaluative Assessment of Robotic Skills (GEARS) Scale|GEARS is a validated assessment tool for grading overall technical proficiency for robotic surgery. The overall proficiency score is a composite score of five different measures: depth perception, bimanual dexterity, efficiency, force sensitivity, and robotic control. Each of these subscale scores are graded 1-5, with 1 being poor and 5 being excellent. The total score is the summation of the scores from each of the five subscales and ranges from 5 to 25.|Three weeks after orientation||||units on a scale||Standard Deviation|Mean
2547911|NCT02895295|Primary|Change in Estimated Prescription Drug Spending|Change in estimated prescription drug spending is the difference in estimated spending in US dollars, including both premiums and out-of-pocket spending on prescription drugs, between the participant's 2016 and 2017 plans based on their initial drug list.|within 50 days of the end of the open enrollment period|Study participants who responded to questions about their 2017 plan choice in the final survey administered after open enrollment had ended.|||US dollars||Standard Deviation|Mean
2547912|NCT02895295|Primary|Satisfaction With the Choice Process|"Response to the question of, How satisfied are you with the process of choosing a plan? with 4 potential responses: very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied. The count of participants who responded very satisfied is reported."|within 50 days of the end of the open enrollment period|Study participants who responded to question about satisfaction with the choice process on the final survey|||Participants|||Count of Participants
2547913|NCT02895295|Primary|Decisional Conflict|"Low literacy decisional conflict scale (Linder et al., 2011), edited slightly for context of health insurance rather than treatment choice. The scale has 4 subscales (uncertainty, informed, values clarity and support) with 2 to 3 questions per subscale. Respondents can indicate yes, no, or unsure for each item. An answer of yes receives 0, unsure receives 2 and no receives 4 points. The sum of the responses to each question within a subscale is normalized to a scale of 25. The subscales are then summed to a total score ranging from 0 to 100 where 0 represents the lowest level of decisional conflict and 100 represents the highest level of decisional conflict."|within 50 days of the end of the open enrollment period.|Study participants who responded to decisional conflict questions on the final survey.|||units on a scale||Standard Deviation|Mean
2547914|NCT02895295|Primary|Count of Participants Whose 2017 Plan Differed From Their 2016 Plan|Indicator of whether the self-reported plan of the participant differed before and after open enrollment and the participant reported that s/he changed plans during open enrollment.|within 50 days of the end of the open enrollment period.|Set of participants who responded to questions about plan enrollment in the final survey.|||Participants|||Count of Participants
2547915|NCT02895035|Secondary|Number of Eyes With Pupil Diameter Less Than 6 mm During Cortical Clean-up|Number of eyes with a measured pupil diameter less than 6 mm during cortical clean-up|During cataract surgery, cortical clean-up stage, up to 5 mins|Each participant had two eyes included in the study|||Eyes|Eyes||Count of Units
2547916|NCT02895035|Secondary|Number of Eyes With Pupil Diameter Less Than 6 mm at Any Time During Surgery|Number of eyes with a measured pupil diameter less than 6 mm at any time during surgery|During cataract surgery, with maximum end time of 20 minutes|Each participant had two eyes included in the study|||Eyes|Eyes||Count of Units
2547917|NCT02895035|Secondary|Maximum Intraoperative Change in Pupil Diameter|This is the maximum observed change in pupil diameter, as measured compared to baseline.|During cataract surgery, with maximum end time of 20 minutes|Two eyes from each participant were included|||millimeters|Eyes|Standard Deviation|Mean
2547918|NCT02895035|Primary|Mean Area Under the Curve Change From Baseline in Pupil Diameter Over Time to the End of Cataract Surgery|Mean area under the curve was calculated by assessing the pupil diameter at baseline and then again at 1 minute intervals until the surgery was complete (max 20 minutes). Units are in millimeters*seconds|During cataract surgery, with maximum end time of 20 minutes|Two eyes from each participant were included for all outcome measures.|||millimeters * seconds|Eyes|Standard Deviation|Mean
2548138|NCT02890381|Primary|Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titer|Immunogenicity was assessed pre-inoculation, and at approximately 2 months post-inoculation (Study Day 56). Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre and post time points.|Measured at Day 0 and Day 56|One placebo recipient had missing data at the Day 56 evaluation. All other participants were included.|||Participants|||Count of Participants
2547919|NCT02894840|Secondary|Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer|The analysis was performed only as intention-to-treat (ITT). The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0, 21, 60 and 90). Proportion of increased in GMT Titer > 2.5 at each time of assessment compared with baseline (Day 0) was reported both phase I and phase II|90 days|The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0,21, 60 and 90) were assessed in all studied participants both phase I and phase II. The analysis was performed as intention-to-treat (ITT).|||titer||95% Confidence Interval|Geometric Mean
2547920|NCT02894840|Secondary|Geometric Mean of Immune Response at Every Time of Assessment|The analysis was performed only as intention-to-treat (ITT). The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0,21, 60 and 90)|90 days|The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0,21, 60 and 90) were assessed in all studied participants both phase I and phase II. The analysis was performed as intention-to-treat (ITT).|||titer||95% Confidence Interval|Geometric Mean
2547921|NCT02894840|Secondary|Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer.|Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.|90 days|Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in all studied participants both phase I and phase II. The analysis was performed as intention-to-treat (ITT).|||Participants|||Count of Participants
2547922|NCT02894840|Primary|Number of Participants With Adverse Events|All Adverse Events during 90 days will be analysed in terms of percentage and relationship to study vaccine|90 days|All participants who receive at least one vaccination would be included in the safety population. The analysis will be conducted based on intent-to-treat (ITT) analysis. The population for the ITT analysis is defined as all individuals in the trial. The ITT analysis would include individuals who may not complete follow-up.|||Participants|||Count of Participants
2547923|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).|Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547924|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis|Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547925|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)|Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547926|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis|Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547927|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative)|Rash AEs include any rash AEs, generalised rash and rash.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547928|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis|Rash AEs include any rash AEs, generalised rash and rash.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548139|NCT02890381|Primary|Duration of Virus Shedding in Nasal Washes|Determined separately by a) culture and b) reverse transcription polymerase chain reaction (RT-PCR)|Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28. Last day positive is reported.|Only participants who met the definition of infection were included.|||days||Inter-Quartile Range|Median
2547929|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).|Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547930|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis|Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547931|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).|Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547932|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.|Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547933|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).|Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547934|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.|Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547935|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).|AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547936|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.|AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547954|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547937|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).|AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547938|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.|AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547939|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).|AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547940|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.|AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547941|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).|AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547942|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.|AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome).|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547943|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547944|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548059|NCT02892409|Primary|Percentage of Participants Who Discontinue Due to an Adverse Event (AE)||Baseline up to Day 17|The safety analysis set included all participants who received at least one dose of study drug.|||percentage of participants|||Number
2547945|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547946|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547947|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547948|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547949|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547950|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547951|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547952|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Gastrointestinal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547953|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Respiratory/Miscellaneous) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548060|NCT02892409|Primary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)||Baseline up to Day 17|The safety analysis set included all participants who received at least one dose of study drug.|||percentage of participants|||Number
2547955|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547956|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (General Non-specific) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547957|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547958|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547959|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia ) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547960|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547961|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis (Cumulative).|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547962|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Age Strata, on a Weekly Basis.|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547963|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative),|Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548140|NCT02890381|Primary|Peak Titer of Vaccine Virus Shed|This is the highest value per participant of the titer of vaccine virus shed. It was measured by culture. Only participants who met the definition of infection with vaccine virus were included.|Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28|Only participants who met the definition of infection with vaccine virus were included.|||log 10 Plaque Forming Units (PFU)/mL||Inter-Quartile Range|Median
2547964|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.|Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547965|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).|Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547966|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.|Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547967|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative)|Rash AEs include any rash AEs, generalised rash and rash.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547968|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.|Rash AEs include any rash AEs, generalised rash and rash.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547969|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).|Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547970|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.|Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547971|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).|Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547972|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.|Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547973|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).|Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547974|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.|Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547975|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).|AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547976|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.|AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547977|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).|AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547978|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.|AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547979|NCT02893878|Secondary|Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis in a (Cumulative).|AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547980|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.|AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547981|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis (Cumulative).|AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548206|NCT02886624|Secondary|Number of Participants With Undetectable HIV RNA|Number of participants with undetectable HIV RNA at 12 weeks post treatment (in HIV-positive co-infected patients)|12 weeks|Out of 28 HIV-positive individuals, 27 had available data. All 27 participants analyzed had undetectable HIV RNA.|||Participants|||Count of Participants
2547982|NCT02893878|Secondary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System by Vaccine Group, on a Weekly Basis.|AEIs were presented by categories depending of the nature of the event. - Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia, etc.); - All other presentations that were reported following vaccination (e.g., Bell's palsy, Guillain-Barre syndrome).|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547983|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547984|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547985|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547986|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547987|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547988|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547989|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548061|NCT02892344|Secondary|Number of Patients With First Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period|The annual rate of asthma exacerbations were analyzed using a generalized linear model.|Week 12|The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables|||Count of participants|||Number
2547990|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547991|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547992|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547993|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547994|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547995|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547996|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547997|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548207|NCT02886624|Secondary|Treatment Adherence|Number of patients missing study drug within the last four days during treatment|8 weeks||||Participants|||Count of Participants
2548208|NCT02886624|Secondary|Virological Failure|Number of patients harboring HCV (NS5A and NS3/4) resistance mutations 12 weeks post treatment|12 weeks|Intent-to-treat analysis|||Participants|||Count of Participants
2547998|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2547999|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548000|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548001|NCT02893878|Primary|Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548002|NCT02893878|Primary|Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548003|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).|"The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.~The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR."|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548004|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.|"The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.~The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR."|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548005|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).|"The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.~The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR."|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548006|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.|"The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.~The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR."|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548007|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).|"The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.~The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR."|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548008|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.|"The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.~The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR."|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548009|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).|"The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.~The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR."|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548010|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.|"The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.~The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR."|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548011|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).|"The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.~The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR."|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548012|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.|"The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.~The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR."|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548063|NCT02892344|Secondary|Number of Patients With Asthma Exacerbation Over 12 Weeks|The exacerbation categories are: mild, moderate, severe and the combination of moderate or severe. Time to first asthma exacerbation by exacerbation category. Annual rate of asthma exacerbations by exacerbation category.|Week 12|The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables|||Number of patients|||Number
2548013|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).|"The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years.~The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR."|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548014|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548015|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548016|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548017|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).|Local symptoms included local erythema. The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548018|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.|Local symptoms included local erythema. The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548019|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who receive d the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e . cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548090|NCT02891629|Secondary|Safety Assessment - Number of Device Related Adverse Events|number of device related adverse events reported during the use of the device|2 weeks||||events|||Number
2548209|NCT02886624|Primary|Sustained Virological Response 12 Weeks Post-treatment (SVR12)|Undetectable plasma HCV RNA (<12 IU/mL) 12 weeks post-treatment.|12 weeks|Intent-to-treat analysis|||Participants|||Count of Participants
2548020|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548021|NCT02893878|Primary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e . cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548022|NCT02893878|Primary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.|The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and >65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548023|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).|Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548024|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.|Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548025|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).|Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548026|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.|Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548091|NCT02891629|Primary|Feasibility - Successful Performance Rate of Device Features|Ability to successfully perform at least 70% of device features (controlling the application and Free text features)|2 weeks||||seconds||Standard Deviation|Mean
2548092|NCT02891200|Secondary|Mortality Rate|Assessed at 3 months|Measured at 3 months post enrollment|Patients who withdrew from study are excluded from analysis.|||Participants|||Count of Participants
2548093|NCT02891200|Secondary|Mortality Rate|Assessed at 9 months|Measured at 9 months post enrollment|Patients who withdrew from study are excluded from analysis.|||Participants|||Count of Participants
2548027|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).|Rash AEs include any rash AEs, generalised rash and rash. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548028|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.|Rash AEs include any rash AEs, generalised rash and rash. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548029|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).|Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548030|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.|Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548031|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).|Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548032|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.|Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548033|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).|Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548094|NCT02891200|Secondary|Mortality Rate|Assessed at 6 months|Measured at 6 months post enrollment|Patients who withdrew from study are excluded from analysis.|||Participants|||Count of Participants
2548141|NCT02890381|Primary|Number of Participants Infected With RSV Vaccine|Defined as 1) vaccine virus identified in a nasal wash from Study Day 0-28 (a binary outcome based on nasal washes) or 2) greater than or equal to 4-fold rise in serum RSV-neutralizing antibody titer between Study Days 0 and 56.|Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28 for nasal washes, and at Days 0, 56 for serum RSV-neutralizing antibodies|All participants were included.|||Participants|||Count of Participants
2548034|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.|Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548035|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).|General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, irritability and malaise. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548036|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.|General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, irritability and malaise. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548037|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).|Local symptoms include local erythema. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548038|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.|Local symptoms include local erythema. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548039|NCT02893878|Primary|Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548040|NCT02893878|Primary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.|The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548062|NCT02892344|Secondary|The Number of Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period|Annual incidence rate of asthma exacerbation by severity of exacerbation. The number of asthma exacerbation is used to calculate annual incidence rate. A severe asthma exacerbation is SCS (Systemic Corticosteroids) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations|Week 12|The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables|||Number of exacerbation|||Number
2548041|NCT02893878|Primary|Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).|AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|Cumulative weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated at any point from study start up to the week before the week of interest (i.e. cumulatively since the beginning of the study) and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548042|NCT02893878|Primary|Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.|AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.|Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)|The Weekly safety vaccinated cohorts (for each calendar Week 38 to 48) included subjects who were vaccinated the week before the week of interest and were registered during the safety follow-up period (from vaccination up to 7 days post vaccination).|||Participants|||Count of Participants
2548043|NCT02892734|Other Pre-specified|Immune Signature Assessed by Exosome Analysis in Blood Samples||At baseline|||||||
2548044|NCT02892734|Other Pre-specified|ctDNA Assessed by Exosome Analysis in Blood Samples||At baseline|||||||
2548045|NCT02892734|Other Pre-specified|PD-L1 Expression Measured in Tissue Samples||At baseline|||||||
2548046|NCT02892734|Other Pre-specified|iScore|Assess the predictive value of baseline iSCORE using tissue samples.|At baseline|||||||
2548047|NCT02892734|Secondary|Incidence of Adverse Events|Assess the safety and tolerability of nivolumab and ipilimumab in patients with recurrent IBC by measuring the number, frequency, and severity of adverse events according to the National Cancer Institute Common Terminology Criteria Adverse events (CTCAE) v 4.03.|Up to 12 weeks after study treatment|||||||
2548048|NCT02892734|Secondary|Overall Survival|To assess overall survival in patients with recurrent HER2 negative IBC treated with nivolumab and ipilimumab, patients will be followed from the start of treatment until 2 years post-treatment or death, whichever occurs first, and average survival time will be measured.|Up to 2 years|||||||
2548049|NCT02892734|Secondary|Clinical Benefit Rate (CBR)|Evaluate the CBR according to RECIST criteria v1.1 in patients with recurrent IBC treated with nivolumab and ipilimumab. Patients will have imaging scans every 8 weeks for the first 13 months and every 12 weeks thereafter, assessed up to 2 years.|Up to 2 years|||||||
2548050|NCT02892734|Secondary|Overall Response Rate (ORR)|Evaluate the ORR according to RECIST criteria v1.1 in patients with recurrent IBC treated with nivolumab and ipilimumab. Patients will have imaging scans every 8 weeks for the first 13 months and every 12 weeks thereafter, assessed up to 2 years.|Up to 2 years|||||||
2548051|NCT02892734|Primary|Progression Free Survival (PFS)|PFS in patients with newly recurrent HER2 negative IBC treated with nivolumab and ipilimumab as evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 assessed from the date of first study treatment to the date of disease progression or death from any cause, assessed up to 2 years.|Up to 2 years|Data not collected and analyzed as study closed to accrual early due to slow accrual.||||||
2548052|NCT02892513|Primary|Total Narcotic Consumption During Hospital Stay|Total inpatient narcotic use measured in oral morphine equivalents per day (OME)|5 days|1 participant withdrew before device was applied and data not collected for analysis.|||Oral Morphine Equivalents per day (OME)||Standard Deviation|Mean
2548053|NCT02892409|Primary|Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for Bismuth||Day 14 pre-dose and at multiple timepoints (up to 12 hours) post-dose|The PK analysis set included all participants who received study drug, had sufficient plasma/urine concentration data to calculate at least one PK parameter, and had no significant protocol deviations. The PK analysis set where data was available at specified timepoints.|||nanogram (ng)||Standard Deviation|Mean
2548054|NCT02892409|Primary|AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Bismuth||Day 14 pre-dose and at multiple timepoints (up to 12 hours) post-dose|The PK analysis set included all participants who received study drug, had sufficient plasma/urine concentration data to calculate at least one PK parameter, and had no significant protocol deviations.|||hours nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
2548055|NCT02892409|Primary|Cmax: Maximum Observed Plasma Concentration for Bismuth||Day 14 pre-dose and at multiple timepoints (up to 12 hours) post-dose|The pharmacokinetic (PK) analysis set included all participants who received study drug, had sufficient plasma/urine concentration data to calculate at least one PK parameter, and had no significant protocol deviations.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2548056|NCT02892409|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose||Baseline up to Day 15|The safety analysis set included all participants who received at least one dose of study drug.|||percentage of participants|||Number
2548057|NCT02892409|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose||Baseline up to Day 15|The safety analysis set included all participants who received at least one dose of study drug.|||percentage of participants|||Number
2548058|NCT02892409|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose||Baseline up Day 15|The safety analysis set included all participants who received at least one dose of study drug.|||percentage of participants|||Number
2548064|NCT02892344|Secondary|Quality of Life Assessed by Asthma Quality of Life Questionnaire AQLQ-S 12|The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.|week 12|The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables|||Score||Standard Error|Least Squares Mean
2548065|NCT02892344|Secondary|Percentage of Rescue Medication Free Days Over 12 Weeks|Percentage of rescue medication free days over 12 weeks of treatment period|week 12|The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables|||Percentage||Standard Error|Least Squares Mean
2548066|NCT02892344|Secondary|Rescue Medication Use Over 12 Weeks|Rescue salbutamol/albuterol usage (mean daily, nighttime and daytime use) from e-Diary recordings over 12 weeks of treatment|week 12|The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables|||Number of puffs of rescue medication||Standard Error|Least Squares Mean
2548067|NCT02892344|Secondary|ACQ-7 at Week 4|ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control|week 4|The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables|||Units on a scale||Standard Error|Least Squares Mean
2548068|NCT02892344|Secondary|Daily E-diary Over 12 Weeks|Percentage of asthma symptoms free days, the percentage of nights without nighttime awakenings, and the percentage of mornings without symptoms on awakening as recorded by daily electronic Diary (e-Diary) over 12 weeks of treatment|week 12|The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables|||Percentage||Standard Error|Least Squares Mean
2548069|NCT02892344|Secondary|Percentage of Patients With ACQ-7 MID at Week 12|MID is Minimum Important Difference. ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control. Percent of patients achieving the minimal important difference (MID) in ACQ-7 (i.e. at least 0.5 decrease from baseline) will be measured.|week 12|The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables|||Percentage|||Number
2548070|NCT02892344|Secondary|PEF Over 4 and 12 Weeks|Morning and Evening Peak Expiratory Flow Rate (PEF) will be measured. PEF is the peak expiratory flow, the maximum speed of expiration|week 12|The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables|||L/min||Standard Error|Least Squares Mean
2548071|NCT02892344|Secondary|FVC Over 12 Weeks|FVC is the total amount of air exhaled during the FEV test. Forced Vital Capacity (FVC) and Forced Expiratory Flow between 25% and 75% of FVC (FEF25-75) will be measured|week 12|The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables|||Liters||Standard Error|Least Squares Mean
2548072|NCT02892344|Secondary|Pre-dose FEV1 at Week 4|Pre-dose FEV1 is defined as the mean of -45 min and -15 min FEV1 values pre-evening dose|week 4|The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables|||Liters||Standard Error|Least Squares Mean
2548073|NCT02892344|Secondary|Trough FEV1 at Day 2|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing|Day 2|The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables|||Liters||Standard Error|Least Squares Mean
2548104|NCT02891174|Secondary|Mean Pain Score by Nursing Assessment|Pain scores using a 0-10 scale as assessed by nursing during the 48 hours from initial study medication administration will be abstracted from the participant's medical record. Clinical Pain Scale: 0=no pain to 10=worst pain. All pain scores during the first intervention (0-24 hours) and second intervention (24-48) are included according to intention-to-treat principles.|0-24 hours and 24-48 hours after initial study medication administration|Of 37 women in intention-to-treat analyses, 35 were analyzed in ibuprofen treatment; 2 of those women had no recorded nursing pain score in ibuprofen period (n=33). 36 women were analyzed in acetaminophen treatment, but 1 of those women had no recorded nursing pain score in acetaminophen period (n=35).|||score on a scale||Standard Deviation|Mean
2548266|NCT02883244|Secondary|Change in Gingivitis by Probing Pocket Depth at 28 Days|6 sites per tooth: distobuccal, distal, mesiobuccal, and distolingual, lingual and mesiolingual surfaces: (mm) Change = (28 days measurement - Baseline measurement)|Baseline and 28 days||||mm||Standard Deviation|Mean
2548074|NCT02892344|Secondary|ACQ-7|ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control. the ACQ-7 was used to assess improvements in asthma symptom control. The ACQ-7, a seven-item disease-specific instrument developed and validated to assess asthma control in patients in clinical trials as well as in individuals in clinical practice, was provided to the site. All seven items were then scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating no control. The questions were equally weighted and the total score was the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the patient while the last question (question 7) was completed by the study investigator using spirometry data generated by the spirometry equipment.|week 12|The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables.|||Units on a scale||Standard Error|Least Squares Mean
2548075|NCT02892344|Primary|Trough FEV1|demonstrate the superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents. Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured by spirometry.|week 12|The Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. The FAS was used in the analysis of all efficacy variables.|||Liters||Standard Error|Least Squares Mean
2548076|NCT02892110|Secondary|Cannabis Use Quantity|Cannabis use sessions per day measured by Timeline Followback (self-report) at twice weekly visits during Weeks 4, 5 and 6 of the active treatment phase.|3 weeks (Week 4-6 of active treatment period)||||sessions per day||95% Confidence Interval|Mean
2548077|NCT02892110|Secondary|Number of Participants With Cannabis Abstinence|Self reported abstinence from Timeline Followback, verified by urine cannabinoid measures|3 weeks (Week 4-6 of active treatment period)||||Participants|||Count of Participants
2548078|NCT02892110|Primary|Cannabis Withdrawal Symptoms During Active Treatment|"For this outcome, the negative affect subscale items of The Cannabis Withdrawal Scale (items 5 [I felt nervous], 6 [I had some angry outbursts], 7 [I had mood swings], 8 [I felt depressed], 9 [I was easily irritated], 15 [Life seemed an uphill struggle], 18 [I felt physically tense], restlessness (item 11, I felt restless), and/or urge to smoke (items 1 and 10, The only thing I could think about was smoking some cannabis and I had been imagining being stoned) were averaged at Weeks 4, 5, and 6 and for an overall 4-6 week value, with minimum score of the subscale being 0 and maximum score being 100 (higher score indicating worse outcome)."|3 weeks (Week 4-6 of active treatment period)||||score on a scale||Standard Deviation|Mean
2548079|NCT02892019|Secondary|Symptoms as Recorded by Patient E-diary (Percentage of Asthma Symptoms Free Days)|Symptoms as recorded by patient e-diary for indacaterol acetate 75 μg and 150 μg o.d. (mean change)|2 weeks|full analysis set|||percentage||Standard Deviation|Mean
2548080|NCT02892019|Secondary|Symptoms as Recorded by Patient E-diary (Mean Total Daily Symptom Score)|Symptoms as recorded by patient e-diary for indacaterol acetate 75 μg and 150 μg o.d. (mean change) The scale rages from 0 (no problem) - 4 (very severe problems).|2 weeks|full analysis set|||score on a scale||Standard Deviation|Mean
2548081|NCT02892019|Secondary|Forced Expiratoty Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC)|FEV1 and FVC at 30 minutes and 1-hour post dose at week 2 for indacaterol acetate 75 μg and 150 μg o.d.|2 weeks|full analysis set|||L||Standard Deviation|Mean
2548082|NCT02892019|Secondary|Rescue Medication Usage (Percentage of Rescue Medication Free Days)|Rescue medication usage over 2 weeks of treatment as determined by patient diary data for indacaterol acetate 75 μg and 150 μg o.d.|2 weeks|full analysis set|||percentage||Standard Deviation|Mean
2548083|NCT02892019|Secondary|Rescue Medication Usage (Mean Daiily Number of Puffs)|Rescue medication usage over 2 weeks of treatment as determined by patient diary data for indacaterol acetate 75 μg and 150 μg o.d.Results given as mean change of puffs of rescue medication.|2 weeks|full analysis set|||number of puffs||Standard Deviation|Mean
2548084|NCT02892019|Secondary|Pre-dose Morning and Evening Peak Expiratoty Flow (PEF)|Pre-dose morning and evening PEF over 2 weeks of treatment as determined by electronic peak flow meter data (mean change)|2 weeks|full analysis set|||L/min||Standard Deviation|Mean
2548085|NCT02892019|Secondary|Asthma Control as Assessed by Pediatric Interviewer-administered Asthma Control Questionnaire|"Asthma Control as assessed by pediatric interviewer-administered Asthma Control Questionnaire (ACQ-IA) score at week 2 (mean change). A decrease in the score shows an improvement.~The scale ranges from 0 (no symptoms) to 6 (severe symptoms every day). Results are given as a change as compared from baseline"|2 weeks|full analysis set|||score on a scale||Standard Deviation|Mean
2548086|NCT02892019|Secondary|Systemic Exposure to Indacaterol in Plasma|Systemic exposure to indacaterol in plasma following sparse pharmacokinetic (PK) sampling on Day 1 and Day 14 after inhalation of indacaterol acetate 75 μg and 150 μg.|day 1, day 14|safety set|||pg/mL||Standard Deviation|Mean
2548087|NCT02892019|Primary|Trough Forced Expiratoty Volume in 1 Second (FEV1)|"Change from baseline in pre-dose trough FEV1 after 2 weeks of treatment with indacaterol acetate 75 μg o.d and 150 μg o.d.~The primary endpoint is change from baseline in pre-dose trough FEV1 (mL) after 2 weeks of treatment. The pre-dose trough FEV1 (mL) is defined as the mean of the two FEV1 (mL), values measured at -45 min and -15 min pre-dose."|2 weeks|full analysis set|||L||Standard Deviation|Mean
2548088|NCT02891863|Primary|Conversion Efficacy of Low Energy VT Therapies|Effectiveness of LEVER Acute Study System low energy therapies to convert MVTs will be collected and tracked as an aggregate success rate (%) on a per-attempt basis for each therapy tested.|Acute - eg within 5 seconds of test therapy delivery|6 of 9 subjects had at least one inducible VT, a total of 14 attempts to convert VT with multiple pulses were delivered and none converted the VT in any subject.|||percentage of VF conversion success|Attempts at VF Conversion||Number
2548089|NCT02891863|Primary|System and Procedure Related Adverse Events|All system and procedure-related adverse events through 7 days (-1/+3 days) post-procedure will be collected and tracked.|7 days post-procedure||||participants|||Number
2548095|NCT02891200|Secondary|Change in Health-related Quality of Life at 9 Months|Change in health-related quality of life (HRQoL) at 9 months post-enrollment from baseline. The HRQoL is measured using the St. George Respiratory Questionnaire (SGRQ), a validated instrument that will be administered to participant by a trained research team member. SGRQ measures health-related quality of life among patients with respiratory diseases. It is a 40 items questionnaire grouped into three domains (Symptoms, Activity, and Impacts). The overall summary score is calculated by summing the weights of all items with positive response in the questionnaire and dividing that by sum of weights for all items, times 100. Total scores range from 0 to 100. Higher score reflect worse quality of life and a decrease in score indicates improvement HRQoL . Change in score was calculated as the total score at 9 month post-enrollment minus total score at baseline ( i.e at enrollment ). Minimum clinically important difference (MCID) for SGRQ is a 4-point improvement (i.e decrease in score).|enrollment to 9 months|The Number of Participants Analyzed for change in quality of life at 9 months is different from that at 6 months because not all participants were candidates to receive the 9 months quality of life measurement due to end of project period.|||units on a scale||Standard Deviation|Mean
2548096|NCT02891200|Secondary|Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 3 Months|All hospitalizations and ED visits will be counted from time of participant enrollment into study till 3 months afterwards.|Measured at 3 months post enrollment|Patients who have passed away or withdrew before 3 months from enrollment are excluded from the analysis|||visits per participant||95% Confidence Interval|Mean
2548097|NCT02891200|Secondary|Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 9 Months|All hospitalizations and ED visits will be counted from time of participant enrollment into study till 9 months afterwards.|Measured at 9 months post enrollment|Patients who have passed away or withdrew before 9 months from enrollment are excluded from the analysis|||visits per participant||95% Confidence Interval|Mean
2548098|NCT02891200|Secondary|Combined Number of All-cause Hospitalizations and ED Visits Per Participant at 6 Months|All hospitalizations and ED visits will be counted from time of participant enrollment into study till 6 months afterwards.|Measured at 6 months post enrollment|Patients who have passed away or withdrew before 6 months from enrollment are excluded from the analysis|||visits per participant||95% Confidence Interval|Mean
2548099|NCT02891200|Secondary|Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 3 Months|"All hospitalizations and ED visits discharge diagnoses are reviewed and those that are COPD-related are counted from time of participant enrollment into study till 3 months afterwards. A visit is coded as COPD-related if:~The principle discharge diagnosis was any of the following : J41.0 ; J41.1; J41.8; J42; J43.0; J43.1; J43.2; J43.8; J43.9; J44.0; J44.1; J44.9.~Or~The principle discharge diagnosis was respiratory failure AND the visit had a secondary diagnosis of J44.0 or J44.1 . The respiratory failure codes are J96.00; J96.01; J96.02; J96.20; J96.21; J96.22; J96.90; J96.91; J96.92; R06.03; R09.2 ."|Measured at 3 months post enrollment|Patients who have passed away or withdrew before 3 months from enrollment are excluded from the analysis|||COPD-related visits per participant||95% Confidence Interval|Mean
2548100|NCT02891200|Secondary|Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 9 Months|"All hospitalizations and ED visits discharge diagnoses are reviewed and those that are COPD-related are counted from time of participant enrollment into study till 9 months afterwards. A visit is coded as COPD-related if:~The principle discharge diagnosis was any of the following : J41.0 ; J41.1; J41.8; J42; J43.0; J43.1; J43.2; J43.8; J43.9; J44.0; J44.1; J44.9.~Or~The principle discharge diagnosis was respiratory failure AND the visit had a secondary diagnosis of J44.0 or J44.1 . The respiratory failure codes are J96.00; J96.01; J96.02; J96.20; J96.21; J96.22; J96.90; J96.91; J96.92; R06.03; R09.2 ."|Measured at 9 months post enrollment|Patients who have passed away or withdrew before 9 months from enrollment are excluded from the analysis|||COPD-related visits per participant||95% Confidence Interval|Mean
2548101|NCT02891200|Secondary|Combined Number of COPD-related Hospitalizations and ED Visits Per Participant at 6 Months|"All hospitalizations and ED visits discharge diagnoses are reviewed and those that are COPD-related are counted from time of participant enrollment into study till 6 months afterwards. A visit is coded as COPD-related if:~The principle discharge diagnosis was any of the following : J41.0 ; J41.1; J41.8; J42; J43.0; J43.1; J43.2; J43.8; J43.9; J44.0; J44.1; J44.9.~Or~The principle discharge diagnosis was respiratory failure AND the visit had a secondary diagnosis of J44.0 or J44.1 . The respiratory failure codes are J96.00; J96.01; J96.02; J96.20; J96.21; J96.22; J96.90; J96.91; J96.92; R06.03; R09.2 ."|Measured at 6 months post enrollment|Patients who have passed away or withdrew before 6 months from enrollment are excluded from the analysis|||COPD-related visits per participant||95% Confidence Interval|Mean
2548102|NCT02891200|Primary|Change in Health-related Quality of Life at 6 Months|Change in health-related quality of life (HRQoL) at 6 months post-enrollment from baseline. The HRQoL is measured using the St. George Respiratory Questionnaire (SGRQ), a validated instrument that will be administered to participant by a trained research team member. SGRQ measures health-related quality of life among patients with respiratory diseases. It is a 40 items questionnaire grouped into three domains (Symptoms, Activity, and Impacts). The overall summary score is calculated by summing the weights of all items with positive response in the questionnaire and dividing that by sum of weights for all items, times 100. Total scores range from 0 to 100. Higher score reflect worse quality of life and a decrease in score indicates improvement HRQoL . Change in score was calculated as the total score at 6 month post-enrollment minus total score at baseline ( i.e at enrollment ). Minimum clinically important difference (MCID) for SGRQ is a 4-point improvement (i.e decrease in score).|enrollment to 6 months||||units on a scale||Standard Deviation|Mean
2548103|NCT02891174|Secondary|Satisfaction With Pain Control During 24 Hours of Exposure Each to Ibuprofen and Acetaminophen|A brief survey on satisfaction with pain control during the first 24 hours post-partum and the second 24 hours post-partum, as well as overall during post-partum stay will be administered prior to discharge using a 1-5 Likert scale: 1=not satisfied to 5=extremely satisfied.|24 hours and 48 hours after initial study medication administration|11 women in the ibuprofen first group and 6 women in the the acetaminophen first group completed the satisfaction survey prior to discharge.|||units on a scale||Inter-Quartile Range|Median
2548158|NCT02888756|Secondary|Functional Cure|proportion of patients with viral load below detectable level of 50 copies/mL in plasma after ATI, week 18|week 18|One participant from the the iHIVARNA-01 group did not interrupt ART and therefor could not be analysed for time to viral rebound. Therefore the number in this group is 15 in stead of 16 at start of the trial.|||Participants|||Count of Participants
2548105|NCT02891174|Secondary|Change in Self-reported Pain Score 2 Hours After First Intervention|Prior to the first dose of pain medication, participants will take a brief, self-administered survey to assess abdominal and overall pain using a 0-10 scale. Two hours after the first dose of study drug, participants will repeat the self-administered survey to assess abdominal, perineal, and overall pain using a 0-10 scale. Clinical Pain Scale: 0=no pain to 10=worst pain.|At the time of first dose of study drug and 2 hours after|14 women in the ibuprofen first group and 8 women in the the acetaminophen first group completed pain surveys before and 2 hours after 1st dose of study drug.|||score on a scale||Standard Deviation|Mean
2548106|NCT02891174|Primary|Difference in Systolic Blood Pressure (SBP)|The adjusted mean difference in systolic blood pressure after 24 hours of exposure each to ibuprofen and acetaminophen.|24 hours following intervention|37 women who received >=1 dose of study drug were included in intention-to-treat analyses. 35 women had blood pressure recorded in the intended ibuprofen period; 2 excluded due to discharge prior to cross-over. 36 women had blood pressure recorded in the intended acetaminophen period; 1 excluded with no blood pressure measured after cross-over.|||mmHg||Standard Deviation|Mean
2548107|NCT02891070|Post-Hoc|Number of Surgical Site Infections (SSI)|Surgical site infections were evaluated by the surgeon or designated physician according to United States (US) National Healthcare Safety Network (NHSN) criteria as specified in the study protocol.|Day 0 (Intra-operative) to Day 30 (+/-3 days) post-operative|Safety analysis set (SAS): The SAS consisted of all patients who were treated with IP/Control. Patients were analyzed as treated.|||SSI|||Number
2548108|NCT02891070|Secondary|Length of Stay in Hospital (Days).|Days in hospital calculation is Day 0 - Discharge.|Day 0 to Day 60 (Study Completion)|Per-protocol analysis set (PPS): The PPS was defined as a subset of the FAS. Patients with any major deviation that may have impacted the primary efficacy parameter were excluded from the PPS.|||Days||Standard Deviation|Mean
2548109|NCT02891070|Secondary|Time From Dural Closure (Application of IP) Until End of Surgery|Suture closure techniques include continuous simple, continuous locked, interrupted.|Day 0 (Intra-operatively)|Per-protocol analysis set (PPS): The PPS was defined as a subset of the FAS. Patients with any major deviation that may have impacted the primary efficacy parameter were excluded from the PPS.|||Minutes||Standard Deviation|Mean
2548110|NCT02891070|Secondary|Duration in Surgery (Minutes)|Patients undergoing elective cranial surgery for the treatment of a pathological condition (e.g., benign/malignant tumours, vascular malformations, or Chiari type 1 malformations) specifically located in the posterior fossa (PF) or supratentorial (ST) regions.|Day 0 (intra-operatively)|Per-protocol analysis set (PPS): The PPS was defined as a subset of the FAS. Patients with any major deviation that may have impacted the primary efficacy parameter were excluded from the PPS.|||Minutes||Standard Deviation|Mean
2548111|NCT02891070|Secondary|Number of Participants With CSF Leaks Within 30 (+3) Days Post-operatively|Cerebrospinal fluid leak was defined as any overt flow, seepage, weeping, or sweating of CSF through the dura suture line, regardless of volume. All post-operative CSF leaks were primarily diagnosed based on a detailed history and physical examination, including neurological examination. Although not standard of care post-operatively, imaging tests such as computed tomography/magnetic resonance imaging (MRI) were considered if there was a high clinical suspicion of a CSF leak.|Day 0 (Intra-operative) to Day 30 (+/-3 days) post-operative|Per-protocol analysis set (PPS): The PPS was defined as a subset of the FAS. Patients with any major deviation that may have impacted the primary efficacy parameter were excluded from the PPS.|||Participants|||Count of Participants
2548112|NCT02891070|Secondary|Number of Participants With no Intra-operative CSF Leaks Following Final Valsalva Maneuver|Assessment of whether the suture line was not watertight causing CSF leaks after up to two product/control applications and Valsalva maneuvers.|Day 0 (Intra-operative)|Per-protocol analysis set (PPS): The PPS was defined as a subset of the FAS. Patients with any major deviation that may have impacted the primary efficacy parameter were excluded from the PPS.|||Participants|||Count of Participants
2548113|NCT02891070|Primary|Number of Participants With No CSF Leak During and After Surgery|Participants who have no intra-operative CSF leak from dural repair after up to two applications during Valsalva maneuver (25 cm H2O for up to 5 - 10 seconds), or post-operative CSF leak within 30 (+3) days post-operatively. The Valsalva maneuver was performed by the anaesthesiologist to increase the intra-thoracic pressure (e.g., by increasing the positive end-expiratory pressure or by giving a large tidal volume and holding the inflating pressure) to approximately 25 cm H2O, constantly for up to 5 - 10 seconds to transiently elevate the intracranial pressure and test for any CSF leaks. The suture line was to be watertight after up to two product/control applications and Valsalva maneuvers.|Day 0 (Intra-operative) to Day 30 (+/-3 days) post-operative|Per-protocol analysis set (PPS): The PPS was defined as a subset of the FAS. Patients with any major deviation that may have impacted the primary efficacy parameter were excluded from the PPS.|||Participants|||Count of Participants
2548114|NCT02890992|Secondary|Absolute Change From Baseline in Ratio Apolipoprotein B/Apolipoprotein A-1 at Week 8|Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.|Baseline, Week 8|Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||ratio (Apo B/Apo A-1)||Standard Error|Least Squares Mean
2548115|NCT02890992|Secondary|Absolute Change From Baseline in Apolipoprotein A-1 at Week 8|Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.|Baseline, Week 8|Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||mg/dL||Standard Error|Least Squares Mean
2548127|NCT02890992|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein (HDL-C) at Week 8|Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baselines value and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.|Baseline, Week 8|Analysis was performed on mITT population.|||percent change||Standard Error|Least Squares Mean
2548116|NCT02890992|Secondary|Absolute Change From Baseline in Fasting Triglyceride at Week 8|Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.|Baseline, Week 8|Analysis was performed on mITT population.|||mmol/L||Standard Error|Least Squares Mean
2548117|NCT02890992|Secondary|Absolute Change From Baseline in HDL-C at Week 8|Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.|Baseline, Week 8|Analysis was performed on mITT population.|||mg/dL||Standard Error|Least Squares Mean
2548118|NCT02890992|Secondary|Absolute Change From Baseline in Lipoprotein(a) at Week 8|Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.|Baseline, Week 8|Analysis was performed on mITT population.|||gram/Liter (g/L)||Standard Error|Least Squares Mean
2548119|NCT02890992|Secondary|Absolute Change From Baseline in Total Cholesterol (Total-C) at Week 8|Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.|Baseline, Week 8|Analysis was performed on mITT population.|||mg/dL||Standard Error|Least Squares Mean
2548120|NCT02890992|Secondary|Absolute Change From Baseline in Non-High-Density Lipoprotein (Non-HDL-C) at Week 8|Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.|Baseline, Week 8|Analysis was performed on mITT population.|||mg/dL||Standard Error|Least Squares Mean
2548121|NCT02890992|Secondary|Absolute Change From Baseline in Apolipoprotein B at Week 8|Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.|Baseline, Week 8|Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||mg/dL||Standard Error|Least Squares Mean
2548122|NCT02890992|Secondary|Percent Change From Baseline in Apolipoprotein A-1 at Week 8|Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.|Baseline, Week 8|Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||percent change||Standard Error|Least Squares Mean
2548123|NCT02890992|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 8|Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.|Baseline, Week 8|Analysis was performed on mITT population.|||percent change||Standard Error|Least Squares Mean
2548124|NCT02890992|Secondary|Percent Change From Baseline in Fasting Triglyceride at Week 8|Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population (in the two steps respectively; with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.|Baseline, Week 8|Analysis was performed on mITT population.|||percent change||Standard Error|Mean
2548125|NCT02890992|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 8|Combined estimates and SE were obtained by combining adjusted means and SE from robust regression model analyses of the different imputed data sets. The robust regression models included the fixed categorical effect of alirocumab dose/dose regimen. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively (with number of imputations = 1000). In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.|Baseline, Week 8|Analysis was performed on mITT population.|||percent change||Standard Error|Mean
2548126|NCT02890992|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 8|Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline values and post-baseline values in at least one of the analysis windows up to Week 8 were used in the model.|Baseline, Week 8|Analysis was performed on mITT population.|||percent change||Standard Error|Least Squares Mean
2548201|NCT02886702|Secondary|Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI|Proportion of subjects with target site plaque elevation, scaling and erythema scores of less than or equal to 1 (Clear or Almost Clear) on the Psoriasis Area Severity Index (PASI) at the Week 12 visit (Day 85 ± 4 days, End of Study).|Week 12|mITT|||Percentage of Participants|||Number
2548128|NCT02890992|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 8|Adjusted LS means and SE at Week 8 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction. All available baseline value and post-baseline values in at least one of the analysis windows used in the model.|Baseline, Week 8|Analysis was performed on mITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure.|||percent change||Standard Error|Least Squares Mean
2548129|NCT02890992|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12: Cohort 4|Adjusted LS means and standard error at Week 12 were obtained from MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction.|Baseline, Week 12|Analysis was performed on mITT population. Data for this outcome measure was planned to be collected for Cohort 4 only.|||percent change||Standard Error|Least Squares Mean
2548130|NCT02890992|Secondary|Percentage of Participants Achieving Calculated LDL-C <110 mg/dL (2.84 mmol/L) at Week 8|Combined estimate for percentage of participants was obtained by averaging out all the imputed percentage of participants reaching the level of interest. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively; with number of imputations = 1000. In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.|At Week 8|Analysis was performed on mITT population.|||percentage of participants|||Number
2548131|NCT02890992|Secondary|Percentage of Participants Achieving Calculated Low Density Lipoprotein Cholesterol (LDL-C) <130 mg/dL (3.37 mmol/L) at Week 8|Combined estimate for percentage of participants was obtained by averaging out all the imputed percentage of participants reaching the level of interest. A two-step multiple imputation procedure was used to address missing values in the mITT population in the two steps respectively; with number of imputations = 1000. In the first step, the monotone missing pattern was induced in the multiply-imputed data. In the second step, the missing data at subsequent visits were imputed using the regression method for continuous variables.|At Week 8|Analysis was performed on mITT population.|||percentage of participants|||Number
2548132|NCT02890992|Secondary|Absolute Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 8|Absolute change in LDL-C was calculated by subtracting baseline value from Week 8 value. Adjusted LS means and SE were obtained using MMRM analysis, with fixed categorical effects of alirocumab dose/dose regimen, time point and dose/dose regimen-by-time point interaction.|Baseline, Week 8|Analysis was performed on mITT population.|||milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
2548133|NCT02890992|Primary|Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 8|Percent change in calculated LDL-C was defined as 100*(calculated LDL-C value at Week 8 - calculated LDL-C value at baseline)/calculated LDL-C value at baseline. All available baseline and post-baseline calculated LDL-C value during the OLDFI efficacy treatment period & within one of the analysis windows up to Week 8 were used in the model. OLDFI efficacy treatment period was defined as the period from first investigational medicinal product (IMP) injection to last OLDFI IMP injection + 21 days(for Cohorts 1 & 2) or +35 days (for Cohorts 3 & 4). Adjusted Least-squares (LS) mean & standard error (SE) at Week 8 were obtained from mixed-effect model with repeated measures (MMRM) analysis, with fixed categorical effects of alirocumab dose/dose regimen (30 mg Q2W [<50 kg], 40 mg Q2W [<50 kg], 50 mg Q2W [>=50 kg], 75 mg Q2W [>=50 kg], 75 mg Q4W [<50 kg],150 mg Q4W [>=50 kg], 150 mg Q4W [<50 kg] and 300 mg Q4W ([>=50 kg] dose), time point & dose/dose regimen-by-time point interaction.|Baseline, Week 8|Analysis was performed on modified intent-to-treat (mITT) population which included all participants who received at least one dose or partial dose of IMP injection and had an evaluable outcome measure during the open-label dose finding efficacy treatment period.|||percent change||Standard Error|Least Squares Mean
2548134|NCT02890381|Secondary|Number of Participants With B Cell Responses to Vaccine|A B cell response to vaccine is indicated by a greater than or equal to 4-fold change in serum antibody titers to RSV F glycoprotein between the pre- and post-inoculation time points, and between pre- and post-RSV surveillance time points.|Measured through participant's last study visit, up to a total of 6 to 10 months depending on when participants enroll in the study|One placebo recipient had missing data for the Day 56 and the pre-RSV surveillance time points. All other participants were included.|||Participants|||Count of Participants
2548135|NCT02890381|Secondary|Magnitude of Serum RSV-neutralizing Antibody Responses in the Vaccine and Placebo Recipients Who Experience Natural Infection With wt RSV During the Subsequent RSV Season.|Only participants who had RSV detected in nasal washes or a greater than or equal to 4-fold rise in serum antibodies during the subsequent RSV season were included. RSV-neutralizing antibody titers were measured pre- and post-RSV surveillance season.|Measured through participant's last study visit, up to a total of 6 to 10 months depending on when participants enroll in the study|Only participants who had RSV detected in nasal washes or a greater than or equal to 4-fold rise in serum antibodies during the subsequent RSV season were included.|||log 2 titers||Inter-Quartile Range|Median
2548136|NCT02890381|Secondary|Number of Participants Who Had Symptomatic, Medically Attended Respiratory and Febrile Illness, by Grade, Among Those Who Experienced Natural Infection With wt RSV During the Subsequent RSV Season|The number of participants who had symptomatic, medically attended respiratory and febrile illness among those who had RSV detected in nasal washes or >=4 fold rise in serum antibodies during the subsequent RSV season were presented. A participant was only counted once in each solicited AE category, and that was in the line corresponding to the highest grade adverse event they had in that category.|Measured through participant's last study visit, up to a total of 6 to 10 months depending on when participants enroll in the study|Only participants who had RSV detected in nasal washes or >=4 fold rise in serum antibodies during the subsequent RSV season were included.|||Participants|||Count of Participants
2548137|NCT02890381|Primary|Serum Antibody Responses to RSV F Glycoprotein as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)|Immunogenicity was assessed at approximately 2 months post-inoculation (Study Day 56).|Measured at Day 56|One placebo recipient had missing data at Day 56. All other participants were included.|||log 2 titers||Inter-Quartile Range|Median
2548202|NCT02886702|Secondary|Disease Severity None or Minimal on IGA|Proportion of subjects with none or minimal disease, a score of 0 or 1 on the IGA at the Week 12 visit (Day 85 ± 4 days, End of Study).|Week 12|mITT|||Percentage of Participants|||Number
2548142|NCT02890381|Primary|Number of Participants With Serious Adverse Events (SAEs)|"A Serious Adverse Event (SAE) is an AE, whether considered related to the study product or not, that:~Results in death during the period of protocol-defined surveillance~Is life threatening: defined as an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death were it more severe~Requires inpatient hospitalization (or prolongation of existing hospitalization): defined as at least an overnight stay in the hospital or emergency ward for treatment that would have been inappropriate if administered in the outpatient setting~Results in a persistent or significant disability/incapacity~Is a congenital anomaly or birth defect~Is an important medical event that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above."|Measured from Day 0 through Day 56|All participants were included.|||Participants|||Count of Participants
2548143|NCT02890381|Primary|Number of Participants With Unsolicited AEs by Grade|Unsolicited adverse events were other events, not included in the solicited AEs. The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each unsolicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. AE grading (Grade 1- mild to Grade 4-life-threatening) was done by DAIDS AE Grading table v2.0 (see References).|Measured from Day 0 through Day 28|All participants were included.|||Participants|||Count of Participants
2548144|NCT02890381|Primary|Number of Participants With Solicited Adverse Events (AEs) by Grade|Solicited adverse events include fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI). The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 3 and Table 4 in the protocol document.|Measured from Day 0 through Day 28|All study participants were included.|||Participants|||Count of Participants
2548145|NCT02890303|Primary|Complete Capsulotomy|"A successful complete Zepto capsulotomy is defined in this protocol to be one that results in a complete 360 degree capsulotomy without any residual tissue bridges visible to the surgeon. If there are such tissue bridges, the surgeon completes the capsulotomy manually.~The primary effectiveness endpoint was defined as :Complete capsulotomy (target ≥ 95% of cases)."|During surgery||||participants|||Number
2548146|NCT02889289|Other Pre-specified|Time in Therapeutic Heart Rate Range (TTR)|TTR is the amount of time the Veteran spends within a target heart range of moderate to vigorous exercise prescribed as greater than 40% heart rate reserve.|(Intervention) 2 times per week for 8 weeks||||Minutes||Standard Deviation|Mean
2548147|NCT02889289|Other Pre-specified|Total Activity Time (TAT)|TAT is a measure of the total time that the Veteran will be participating in mini-game challenges during the 60 minute intervention session.|(Intervention) 2 times per week for 8 weeks||||Minutes||Standard Deviation|Mean
2548148|NCT02889289|Secondary|Heart Rate at Beginning of Mini-game|Heart rated recorded using heart monitor and chest strap at the beginning of each mini-game.|(Intervention) 2 times per week for 8 weeks||||Heart beats per minute||Standard Deviation|Mean
2548149|NCT02889289|Secondary|Heart Rate at End of Mini-game|Heart rated recorded using heart monitor and chest strap at the end of each mini-game.|(Intervention) 2 times per week for 8 weeks||||Heart beats per minute||Standard Deviation|Mean
2548150|NCT02889289|Secondary|Limits of Stability (LOS) - Directional Control|The LOS is performed on the NeuroCom Balance Manager. The LOS test is a goal-directed weight shifting task. The LOS-directional control measures the accuracy of an individual's movement of center of gravity during the task compared to a straight line. This is reported as a percentage without units.|(Baseline) Weeks 1,2,3,4,6,13,14; (Intervention) Weeks 1, 3, 4, 6, 8; (Retention) Weeks 1, 2, 3, 4, 5||||percentage of accuracy||Standard Deviation|Median
2548151|NCT02889289|Primary|Dynamic Gait Index (DGI)|The DGI is a common clinical measure used to evaluate dynamic balance and coordination during a person's daily activities. This test was developed by Shumway-Cook and features 8-items which assess a person's ability to walk while turning their head, changing speed, and navigating obstacles. The DGI is scored from 0 to 24 where higher scores indicate higher dynamic balance function.|Changes from (Baseline) Weeks 1,2,3,4,6,13,14 to (Intervention) Weeks 1, 3, 4, 6, 8 and to (Retention) Weeks 1, 2, 3, 4, 5||||units on a scale||Standard Deviation|Median
2548152|NCT02888756|Secondary|Cell-associated RNA Viral Reservoir|effect on reservoir as measured by changes in the intracellular viral RNA copy numbers per million cells during and after immunization|day 0-30 (week 4, week 4 + 1 day and week 5) and day 30-80 (week 6), 80-150 days (week 18) and >150 days (week 30)||||delta log copies RNA/ml||95% Confidence Interval|Mean
2548153|NCT02888756|Secondary|Transcriptomics|host protein mRNA expression profiles in whole blood|week 6 and 18|data were not collected||||||
2548154|NCT02888756|Secondary|Viral Immune Escape|viral immune escape: change in % mutated epitopes from pre-cART to post-ATI|week 18|data were not collected||||||
2548155|NCT02888756|Secondary|Proviral DNA Reservoir|effect on reservoir as measured by changes in the proviral DNA copy numbers per million cells during and after immunization|day 0-90 (week 4, week 4 + 1 day and week 5 and week 6) and day 90-130 (week 18) and day >130 (week 30)||||delta log copies DNA /10E6 cel||95% Confidence Interval|Mean
2548156|NCT02888756|Secondary|CD8 T Cell Mediated Viral Suppression|The capacity of CD8 T cells to suppress virus production in HIV infected autologous CD4 T cells, after vaccination. For this purpose PBMC are isolated and separated in CD8 and CD4 T cells. CD4 cells are infected with HIV. Thereafter CD4 cells are co-cultured with pre-stimulated CD8 cells and the capacity to suppress virus production at different effector to target (E:T) ratios is measured, by the change of p24 Gag production. Pannus et al AIDS 2019, PMID: 30702513|week 4||||log(pg/ml)||95% Confidence Interval|Mean
2548157|NCT02888756|Secondary|Primary Immune Response Against Vaccine|Change in frequency of at least 0.7log10 HIV-specific T-cell responses between baseline and week 6|from baseline to week 6||||delta log spot forming units||95% Confidence Interval|Mean
2548308|NCT02881658|Secondary|Change of Low Density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
2548159|NCT02888756|Secondary|Change in Plasma Viral Load|difference in log10 copies/ml plasma viral load in vivo after analytical treatment interruption (ATI, week 6-restart ART), compared to placebo WFI|week 6-18|One participant from the the iHIVARNA-01 group did not interrupt ART and therefor could not be analysed for time to viral rebound. Therefore the number in this group is 15 in stead of 16 at start of the trial.|||log10 copies/ml||95% Confidence Interval|Geometric Mean
2548160|NCT02888756|Secondary|Time to Viral Rebound|time until viral rebound (defined as two consecutive measurements of plasma viral load > 1000 copies/mL separated by at least 15 days) after discontinuation at week 6.|week 6-18|One participant from the the iHIVARNA-01 group did not interrupt ART and therefor could not be analysed for time to viral rebound. Therefore the number in this group is 15 in stead of 16 at start of the trial.|||days||95% Confidence Interval|Median
2548161|NCT02888756|Secondary|Immunogenicity as Measured by Intracellular Cytokine Staining (ICS)|HIV-specific CD4+ and CD8+ T cell responses after immunization by the number of poly-functional T cells as determined by intracellular cytokine staining, (ICS).|week 10, 18 and 30|The data were not collected. In the protocol it was pre-specified, that ICS would not be done if Elispot results did not show immunogenicity of the study product. This analysis was not performed, because the results from the Elispot assay at the same time points showed no increase in the number of spot-forming units, also see primary outcome two.||||||
2548162|NCT02888756|Primary|Immunogenicity as Measured by Elispot|Change from baseline immunogenicity as measured by ELISPOT at week 6 and 18, i.e. two weeks and 14 weeks after the last immunization compared to both control groups|week 6 and week 18||||delta log difference spot forming units||95% Confidence Interval|Mean
2548163|NCT02888756|Primary|Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0|"Grade 3 or above local adverse event (pain, cutaneous reactions including induration).~Grade 3 or above systemic adverse event (temperature, chills, headache, nausea, vomiting, malaise, and myalgia).~Grade 3 or above other clinical or laboratory adverse event confirmed at examination or on repeat testing respectively.~Any event attributable to vaccination leading to discontinuation of the immunisation regimen."|week 6||||Participants|||Count of Participants
2548164|NCT02888171|Secondary|Change in Fibroblast Growth Factor 23 From Baseline to the End of Treatment|The change in fibroblast growth factor 23 concentrations from the baseline visit to the 12-week time point.|Baseline and 12 weeks||||pg/ml||95% Confidence Interval|Mean
2548165|NCT02888171|Secondary|Change in Hepcidin From Baseline to the End of Treatment|The change in hepcidin concentrations from the baseline visit to the 12-week time point.|Baseline and 12 weeks||||percentage of change from baseline||Standard Error|Mean
2548166|NCT02888171|Secondary|Change in Hemoglobin From Baseline to End of Treatment|The change in hemoglobin concentrations from the baseline visit to the 12-week time point.|Baseline and 12 weeks||||percentage of change from baseline||Standard Error|Mean
2548167|NCT02888171|Primary|Change in Transferrin Saturation From Baseline to End of Treatment|The change in serum transferrin saturation from the baseline to the end of treatment|Baseline and 12 weeks||||percentage of change from baseline||Standard Error|Mean
2548168|NCT02888171|Primary|Change in Ferritin From Baseline to End of Treatment|The change in serum ferritin concentrations from the baseline of the study to the 12 week time point.|Baseline and 12 weeks||||percentage of change from baseline||Standard Error|Mean
2548169|NCT02888093|Secondary|Symptomatic Prolapse Outcomes|Positive response to PFDI-20 question #3 regarding the presence of a vaginal bulge (yes) AND the presence of bother (somewhat, moderately or quite a bit).|12 months||||Participants|||Count of Participants
2548170|NCT02888093|Secondary|Suture-related Complications|The presence of apical granulation tissue, apical suture exposure, abnormal vaginal discharge, vaginal spotting, post-coital spotting, dyspareunia or patient being able to feel suture.|6 weeks and 12 months||||Participants|||Count of Participants
2548171|NCT02888093|Primary|Pelvic Organ Prolapse Quantification Exam (POP-Q) Point C|Non-inferiority of POP-Q point C. This measure was obtained as originally described by Bump et al. The hymen is used as a fixed reference point. In other words, this is point zero. Point C is measured in cm relative to the hymen with negative values being proximal to the hymen and positive values distal to the hymen. Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy.|12 months||||cm||Full Range|Median
2548172|NCT02888080|Secondary|Change From Baseline in Other Parameters of Pulmonary Function Testing : Percent Predicted DLco, FEV1/FVC, FEV3/FVC, Percent Predicted Forced Expiratory Flow (FEF) 25-75, RV/TLC (Residual Volume /Total Lung Capacity)|To determine the effect of ACZ885 versus placebo on other parameters of pulmonary function testing in patients with sarcoidosis at 24 weeks compared to baseline. Percent Predicted DLco (Diffusion Capacity of Lung for CO), FEV1/FVC, FEV3/FVC (forced expiratory volume in 1 or 3 seconds /forced vital capacity), percent Predicted FEF25-75, RV/TLC|Baseline, week 24|Pharmacodynamic Analysis Set, with measure|||percentage||Standard Deviation|Mean
2548173|NCT02888080|Secondary|Change From Baseline in Other Parameters of Pulmonary Function Testing : Diffusion Capacity of Lung for CO|To determine the effect of ACZ885 versus placebo on other parameters of pulmonary function testing in patients with sarcoidosis at 24 weeks compared to baseline.|Baseline, week 24|Pharmacodynamic Analysis Set, with measure|||mL/min/mmHg||Standard Deviation|Mean
2548174|NCT02888080|Secondary|Change From Baseline of Additional [F-18]FDG-PET Outcomes|To determine the effect of ACZ885 on additional [F-18]FDG-PET outcomes after 12 weeks of treatment compared to placebo. SUVmean: Mean standard uptake value for activity in the focal region volume SUVpeak: Mean standardized uptake value of a sphere (a diamater of approximately 1.2cm - to produce a 1-cm3-volume spherical Region of Interest (ROI) that has the highest average SUV with the lesion volume|Baseline, Week 12|Pharmacodynamic Analysis Set, with measure|||Percentage of Change In SUVmean||Standard Error|Least Squares Mean
2548175|NCT02888080|Secondary|Change From Baseline Distance Walked as Assessed by the 6-minute Walk Test|To determine the effect of ACZ885 versus placebo on the 6-minute walk test distance of patients with sarcoidosis at 12 and 24 weeks compared to baseline|Baseline, Week 12, and Week 24|Pharmacodynamic Analysis Set, with measure|||meter||Standard Deviation|Mean
2548203|NCT02886702|Primary|Treatment Success Assessed by IGA|"Proportion of subjects with treatment success (defined as none, minimal or mild disease, a score of 0, 1 or 2 within the treatment area) on the Investigator's Global Assessment of Disease Severity (IGA) at the Week 12 visit (Day 85 ± 4 days, End of Study)."|Week 12|mITT for superiority versus placebo, PP for equivalence versus Reference|||Percentage of Participants|||Number
2548176|NCT02888080|Secondary|Change From Baseline in High Resolution Computed Tomography (HRCT) Scoring|To determine the effect of ACZ885 versus placebo on HRCT of patients with sarcoidosis at 24 weeks compared to initial HRCT scan as measured by side-by-side comparison by blinded reviewers and HRCT scoring. HRCT score : sum of total parameters scores, each measured in different lung zones (right upper lobe; left upper lobe; right middle lobe; right lower lobe; left lower lobe). The extent of the disease is assessed for each zone to the nearest 10% of parenchymal surface: 0 (no disease) to 10 (91-100% disease).|Baseline, Week 24|Pharmacodynamic Analysis Set, with measure|||score on a scale||Standard Error|Least Squares Mean
2548177|NCT02888080|Secondary|Change From Baseline in Other Parameters of Pulmonary Function Testing (FEV 1, 3, 6 Seconds and Predicted)|To determine the effect of ACZ885 versus placebo on other parameters of pulmonary function testing in patients with sarcoidosis at 24 weeks compared to baseline. Forced Expiratory Volume (FEV) in 1, 3, 6 seconds, predicted and forced expiratory flow 25-75%. Results expressed in change from baseline|Baseline, week 24|Pharmacodynamic Analysis Set, with measure|||Liter/second||90% Confidence Interval|Median
2548178|NCT02888080|Secondary|Change Between Baseline and Week 12 in in the Extrathoracic Region as Measured by SUVmax[F-18]FDG-PET/CT|To determine the effect of ACZ885 on decreasing the maximum standardized uptake value (SUVmax) [F-18]FDG-PET in in the extrathoracic Region after 12 weeks of treatment, compared to placebo.|Baseline, Week 12|Pharmacodynamic Analysis Set, with measure|||percentage (Mean % Change In SUVmax)||Standard Deviation|Mean
2548179|NCT02888080|Secondary|Change Between Baseline and Week 12 in Nodular Uptake Regions as Measured by SUVmax[F-18]FDG-PET/CT|To determine the effect of ACZ885 on decreasing the maximum standardized uptake value (SUVmax) [F-18]FDG-PET in nodules (nodular uptake regions) after 12 weeks of treatment, compared to placebo.|Baseline, Week 12|Pharmacodynamic Analysis Set, with measure|||percentage (Mean % Change In SUVmax)||Standard Deviation|Mean
2548180|NCT02888080|Secondary|Change Between Baseline and Week 12 in Pulmonary Tissue Inflammation (Lung Parenchyma) as Measured by SUVmax[F-18]FDG-PET/CT|To determine the effect of ACZ885 on the change of pulmonary tissue inflammation as measured by SUVmax[F-18]FDG-PET/CT from baseline after 12 weeks of treatment compared to placebo.|Baseline, Week 12|Pharmacodynamic Analysis Set, with measure|||percentage (Mean % Change In SUVmax)||Standard Deviation|Mean
2548181|NCT02888080|Primary|Change Between Baseline and Week 24 in Pulmonary Function as Measured by Spirometry|To compare the effect of ACZ885 versus placebo in the change between baseline and week 24 in pulmonary function as measured by spirometry (Predicted Forced Vital Capacity).|Baseline, Week 24|Pharmacodynamic Analysis Set, with measure|||Percent Predicted Forced Vital Capacity||Standard Deviation|Mean
2548182|NCT02887989|Secondary|Length of Stay) LOS|defined as the number of days from the date of admission to date of hospital discharge. Hour of admission was not available in these data, so patients admitted late on Day 0 (i.e., before midnight), and discharged the following calendar day (i.e., between 00:00 and 23:59), were counted as a 1-day hospital stay. Patients who were admitted and discharged on the same calendar day were considered to have an LOS of 0.|Count of Days in Hospital Stay up to 20||||days||Standard Deviation|Mean
2548183|NCT02887989|Primary|Morphine Milligram Equivalents (MME)|Opioid usage was defined as mean total milligrams of morphine equivalent (MME), calculated by first multiplying the quantity of each prescribed medication by the strength of that medication (milligrams of given opioid per unit dispensed), and then multiplying this quantity-strength product by conversion factors derived from published sources to estimate the milligrams of morphine equivalent to the opioids dispensed in the prescription. The mean pre-intervention MME for subjects in each arm was calculated by adding the morphine equivalents for each prescription dispensed during the 48 hours before intervention, while the post-intervention MME for subjects in each arm was calculated by adding the morphine equivalents for each prescription dispensed during the 48 hours after intervention.|assessed at 48 hours before intervention and 48 hours after intervention|Not all patients received opioids|||Morphine milligram equivalents (MME)||Standard Deviation|Mean
2548184|NCT02887989|Primary|Pain Intensity Ratings (NRS)|"The primary outcome was pain intensity collected via ecological momentary assessment in the course of usual care by hospital staff. At three-to-four hour intervals during waking hours, subjects were asked by their assigned nurse to rate their pain using a standard 11-point numeric rating scale (NRS), where 0 is no pain and 10 is worst imaginable pain. Data are summarized as pre/post mean and in time-series."|Approximately every 3-4 hours for the period 48 hours pre and post intervention||||score on a scale||Standard Deviation|Mean
2548185|NCT02887183|Secondary|Mean Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Clinical Summary Score From Baseline to Month 12|The KCCQ-23 is a self-administered questionnaire and requires, on average, 4-6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL). A change of 5 points on the scale scores, either as a group mean difference or an intra-individual change appears to be clinically significant, based on comparisons of changes in the scale scores to clinical indicators and subject global reports of change. The analysis will be done for groups of subjects with N-terminal pro-brain natriuretic peptide<1000 pg/mL and N-Terminal pro-brain natriuretic peptide>=1000 pg/mL at Month 12.|Baseline, month 12|Full Analysis Set|||Points on a scale||Standard Deviation|Mean
2548186|NCT02887183|Secondary|Change From Baseline in Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) and Change in Left Ventricular Ejection Fraction (LVEF) by Selected Groups of Interest at Month 6|"Pearson's correlation coefficient to examine the association between change in log-transformed NT-proBNP and LVEF from baseline to 6 months overall in subgroups of interest, these subgroups are:~Subjects with HFrEF and low NT-proBNP (<600 if not hospitalized or <400 if hospitalized) or low BNP (<150 if not hospitalized, <100 if hospitalized) at baseline.~Subjects with new onset HF and/or RAAS naïve.~Subjects who are not receiving the target sacubitril/valsartan dose."|Baseline, Month 6|Full Analysis Set|||Pearson's Correlation Coefficient||95% Confidence Interval|Number
2548204|NCT02886624|Secondary|Incidence of HCV Re-infection|Number of patients with positive HCV RNA 48-weeks post treatment.|48 weeks||||Participants|||Count of Participants
2548205|NCT02886624|Secondary|CD4 Cell Count|CD4+ T cell count at 12 weeks post treatment (in HIV-positive co-infected patients)|12 weeks|Out of 28 HIV-positive individuals, 27 had available data.|||cells/mm^3||Inter-Quartile Range|Median
2552243|NCT02797522|Primary|Pharmacokinetics of ARC-521 Injection: Terminal Elimination Rate Constant (Kel), Healthy Volunteers||Through 48 hours post-dose on Day 1|Analysis was not planned or conducted per SAP due to study termination.||||||
2548187|NCT02887183|Secondary|Change From Baseline in Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) and Change in Left Ventricular End Diastolic Volume Index (LVEDVi) by Selected Groups of Interest at Month 6|"Pearson's correlation coefficient to examine the association between change in log-transformed NT-proBNP and LVEDVi from baseline to 6 months overall in subgroups of interest, these subgroups are:~Subjects with HFrEF and low NT-proBNP (<600 if not hospitalized or <400 if hospitalized) or low BNP (<150 if not hospitalized, <100 if hospitalized) at baseline.~Subjects with new onset HF and/or RAAS naïve.~Subjects who are not receiving the target sacubitril/valsartan dose."|Baseline, Month 6|Full Analysis Set|||Pearson's Correlation Coefficient||95% Confidence Interval|Number
2548188|NCT02887183|Secondary|Change From Baseline in Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) and Change in Left Ventricular End Systolic Volume Index (LVESVi) by Selected Groups of Interest at Month 6|"Pearson's correlation coefficient to examine the association between change in log-transformed NT-proBNP and LVESVi from baseline to 6 months overall in subgroups of interest, these subgroups are:~Subjects with HFrEF and low NT-proBNP (<600 if not hospitalized or <400 if hospitalized) or low BNP (<150 if not hospitalized, <100 if hospitalized) at baseline.~Subjects with new onset HF and/or RAAS naïve.~Subjects who are not receiving the target sacubitril/valsartan dose."|Baseline, Month 6|Full Analysis Set|||Pearson's Correlation Coefficient||95% Confidence Interval|Number
2548189|NCT02887183|Secondary|Change From Baseline in Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) and Change in Change in Left Atrial Volume Index (LAVi) by Selected Groups of Interest at Month 6|"Pearson's correlation coefficient to examine the association between change in log-transformed NT-proBNP and LAVi from baseline to 6 months overall in subgroups of interest, these subgroups are:~Subjects with HFrEF and low NT-proBNP (<600 if not hospitalized or <400 if hospitalized) or low BNP (<150 if not hospitalized, <100 if hospitalized) at baseline.~Subjects with new onset HF and/or RAAS naïve.~Subjects who are not receiving the target sacubitril/valsartan dose."|Baseline, Month 6|Full Analysis Set|||Pearson's Correlation Coefficient||95% Confidence Interval|Number
2548190|NCT02887183|Secondary|Change in Log-transformed NT-proBNP Concentration and Change in Echocardiographic Measurements LVESVi, LVEDVi, LAVi, and LVEF From Baseline to Month 6|Pearson's correlation coefficient was calculated between change in log-transformed NT-proBNP and change in echocardiographic measurements LVESVi, LVEDVi, LAVi, and LVEF from baseline to Month 6|Baseline, Month 6|Full Analysis Set|||Pearson's Correlation||95% Confidence Interval|Number
2548191|NCT02887183|Primary|Change in Log-transformed NT-proBNP and Change in Structural Cardiac Measurements LVESVi, LVEDVi, LAVi, and LVEF From Baseline to One Year|Pearson's correlation coefficient was calculated between change in log-transformed NT-proBNP and change in structural cardiac measurements LVESVi, LVEDVi, LAVi, and LVEF from baseline to one year.|Baseline, one year|Full Analysis Set|||Pearson's Correlation||95% Confidence Interval|Number
2548192|NCT02887183|Primary|Change in Left Ventricular Ejection Fraction (LVEF) From Baseline to One Year|Change in Left ventricular ejection fraction (LVEF) from baseline to one year. LVEF is a measurement expressed as a percentage of how much blood the left ventricle pumps out with each contraction.|Baseline, one year|Full Analysis Set|||Percentage||Standard Deviation|Mean
2548193|NCT02887183|Primary|Change in Left Atrial Volume Index (LAVi), Left Ventricular End Diastolic Volume Index (LVEDVi), Left Ventricular End Systolic Volume Index (LVESVi), and From Baseline to One Year|Change in left atrial volume index (LAVi), left ventricular end diastolic volume index (LVEDVi), left ventricular end systolic volume index (LVESVi), and from baseline to one year|Baseline, one Year|Full Analysis Set|||mL/m^2||Standard Deviation|Mean
2548194|NCT02887183|Primary|Change in Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to One Year|Change in concentration of N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to one year|Baseline, one year|Full Analysis Set|||pg/mL||Full Range|Geometric Mean
2548195|NCT02886923|Secondary|The Binocular Functional Visual Performance Under Intermediate Vision Indoor Conditions (50 cd/m2) for Centrally Presented HC TCVA Targets.|Time Controlled Visual Acuity (TCVA) was assessed at 67 cm using 50 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets.|15 Minutes post lens fitting|All subjects who had successfully completed all required visits without any protocol deviations that the study responsible clinician documented as impacting the assessment of the hypotheses.|||-10 x logMAR||Standard Deviation|Mean
2548196|NCT02886923|Secondary|The Binocular Functional Visual Performance Under Distance Night Time Conditions (2.5 cd/m2) for Centrally Presented HC TCVA Targets.|Time Controlled Visual Acuity (TCVA) was assessed at 4 m using 2.5 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets.|15 Minutes post lens fitting|All subjects who had successfully completed all required visits without any protocol deviations that the study responsible clinician documented as impacting the assessment of the hypotheses.|||-10 x logMAR||Standard Deviation|Mean
2548197|NCT02886923|Primary|The Binocular Functional Visual Performance Under Distance Day Time Conditions (250 cd/m2) for Centrally Presented High Contrasts (HC) Time Controlled Visual Acuity (TCVA) Targets.|"Time Controlled Visual Acuity (TCVA) was assessed at 4 m using 250 cd/m2 luminance. The luminance requirements were same at the target and at the eye.~Binocular functional visual performance was measured for the centrally presented high contrasts targets."|15 minutes post lens fit|All subjects who had successfully completed all required visits without any protocol deviations that the study responsible clinician documented as impacting the assessment of the hypotheses.|||-10 x logMAR||Standard Deviation|Mean
2548198|NCT02886715|Primary|Change in Non-inflammatory Lesion Counts|Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts|Week 12|mITT for superiority versus placebo, PP for equivalence versus Reference|||percent change||Standard Error|Least Squares Mean
2548199|NCT02886715|Secondary|Clinical Response of Success|The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment|Week 12|mITT|||percentage of participants|||Number
2548200|NCT02886715|Primary|Change in Inflammatory Lesion Counts|Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts|Week 12|mITT for superiority versus placebo, PP for equivalence versus Reference|||percent change||Standard Error|Least Squares Mean
2548210|NCT02886338|Primary|Assess the Completeness of Capsule Endoscopy|Evaluate the completeness of capsule endoscopic examination. Visualization of the mucosa of esophagus, stomach and duodenum is analyzed separately during and after the capsule endoscopic examination by real time image and capsule video images. We evaluate the percentage of mucosa that can be clearly examined with a 5-point assessment scale (0%, 25%, 50%, 75% and 100% of the visibility of the mucosa of esophagus, stomach, and duodenum)|The outcome measure was performed within 2 weeks after examination|Subjects had completed the magnetic capsule endoscopic examination|||percentage of mucosa visibility||Full Range|Mean
2548211|NCT02886234|Secondary|Patient Health Questionnaire|Patient Health Questionnaire (9 item version) Construct measured = depression Minimum total scale score = 0 Maximum total scale score = 27 Scoring: sum across all 9 items Higher scores represent a worse outcome|Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline||||score on a scale||Standard Deviation|Mean
2548212|NCT02886234|Secondary|Barratt Impulsiveness Scale|Barratt Impulsiveness Scale (short form, 8 items) Construct = Impulsivity Minimum total scale score = 8 Maximum total scale score = 32 Scoring: reverse score items 1, 4, 5, 6, and then sum across all 8 items Higher scores represent a worse outcome|Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline||||score on a scale||Standard Deviation|Mean
2548213|NCT02886234|Secondary|Perceived Stress Scale|Perceived Stress Scale (4-item version) Construct = perceived stress Minimum total scale score = 0 Maximum total scale score = 16 Scoring: reverse score items 2 and 3, then sum across all 4 items Higher scores represent a worse outcome|Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline||||score on a scale||Standard Deviation|Mean
2548214|NCT02886234|Secondary|Five Facet Mindfulness Questionnaire|Five Facet of Mindfulness Questionnaire (15 items; short form) Construct = Mindfulness Minimum total scale score = 15 Maximum total scale score = 75 Scoring: sum across all 15 items Higher scores represent a better outcome|Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline||||score on a scale||Standard Deviation|Mean
2548215|NCT02886234|Secondary|Self-reported Sexual Risk Behavior|Self-reported risky sexual behavior as indicated by the percentage of episodes of condom protected sexual intercourse Higher values are better outcome|Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline||||percentage of sexual events condom used||Standard Deviation|Mean
2548216|NCT02886234|Secondary|Antiretroviral Medication Adherence|Self-reported number of missed days of medication|Baseline; post-intervention, 9 to 10 weeks after baseline; follow-up, 21 to 22 weeks after baseline||||days||Standard Deviation|Mean
2548217|NCT02886234|Secondary|Acceptability of the Intervention|"Number of patients reporting very satisfied or mostly satisfied with their intervention"|post-intervention, 9 to 10 weeks after baseline|3 participants in the MT arm did not complete the acceptability rating at the post-intervention assessment|||Participants|||Count of Participants
2548218|NCT02886234|Primary|Feasibility of Intervention|Feasibility - as indicated by the number of patients attending at least 50% of sessions|post-intervention, 9 to 10 weeks after baseline||||Participants|||Count of Participants
2548219|NCT02885636|Secondary|Change in Resting Pulmonary Elastance|Pulmonary elastance was calculated by the ratio of pulmonary artery systolic pressure/stroke volume.|Baseline, 10 minutes after intervention||||mm Hg/mL||Standard Deviation|Mean
2548220|NCT02885636|Secondary|Change in Exercise Pulmonary Elastance|Pulmonary elastance was calculated by the ratio of pulmonary artery systolic pressure/stroke volume.|Baseline, 10 minutes after intervention during exercise||||mm Hg/mL||Standard Deviation|Mean
2548221|NCT02885636|Secondary|Change in Resting Cardiac Output|Cardiac output was calculated using the direct Fick method of breath-by-breath oxygen consumption (V02)/arterial-venous oxygen content difference (AVO2 diff).|Baseline, 10 minutes after intervention||||L/min||Standard Deviation|Mean
2548222|NCT02885636|Secondary|Change in Exercise Cardiac Output|Cardiac output was calculated using the direct Fick method of breath-by-breath oxygen consumption (V02)/arterial-venous oxygen content difference (AVO2 diff).|Baseline, 10 minutes after intervention during exercise||||L/min||Standard Deviation|Mean
2548223|NCT02885636|Secondary|Change in Resting Right Atrial Pressure (RA)|RA was measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter.|Baseline, 10 minutes after intervention||||mm Hg||Standard Deviation|Mean
2548224|NCT02885636|Secondary|Change in Exercise Right Atrial Pressure (RA)|RA was measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter.|Baseline, 10 minutes after intervention during exercise||||mm Hg||Standard Deviation|Mean
2548225|NCT02885636|Secondary|Change in Resting Pulmonary Artery Pressure|Pulmonary artery pressure was measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter.|Baseline, 10 minutes after intervention||||mm Hg||Standard Deviation|Mean
2548226|NCT02885636|Secondary|Change in Exercise Pulmonary Artery Pressure|Pulmonary artery pressure was measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter.|Baseline, 10 minutes after intervention during exercise||||mm Hg||Standard Deviation|Mean
2548227|NCT02885636|Secondary|Change in Resting Pulmonary Artery Compliance|Pulmonary artery compliance was calculated as the ratio of stroke volume/pulmonary artery pulse pressure.|Baseline, 10 minutes after intervention||||mL/mm Hg||Standard Deviation|Mean
2548228|NCT02885636|Secondary|Change in Exercise Pulmonary Artery Compliance|Pulmonary artery compliance was calculated as the ratio of stroke volume/pulmonary artery pulse pressure.|Baseline, 10 minutes after intervention during exercise||||mL/mm Hg||Standard Deviation|Mean
2548229|NCT02885636|Secondary|Change in Resting Pulmonary Capillary Wedge Pressure (PCWP)|Pulmonary capillary wedge pressure was measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter. PCWP position was confirmed by appearance on fluoroscopy, characteristic pressure waveforms, and oximetry.|Baseline, 10 minutes after intervention||||mm Hg||Standard Deviation|Mean
2548230|NCT02885636|Secondary|Change in Exercise Pulmonary Capillary Wedge Pressure (PCWP)|Pulmonary capillary wedge pressure was measured using a high-fidelity micromanometer advanced through the lumen of a fluid-filled catheter. PCWP position was confirmed by appearance on fluoroscopy, characteristic pressure waveforms, and oximetry.|Baseline, 10 minutes after intervention during exercise||||mm Hg||Standard Deviation|Mean
2548231|NCT02885636|Secondary|Change in Resting Pulmonary Vascular Resistance|The resting PVR after study drug relative to the resting PVR in the initial assessment prior to study drug. This measurement is made by subtracting pulmonary capillary wedge pressure from the mean pulmonary arterial pressure and dividing by cardiac output in liters per minute and reported as wood units.|Baseline, 10 minutes after intervention||||wood units||Standard Deviation|Mean
2548232|NCT02885636|Primary|Change in 20 Watt Exercise Pulmonary Vascular Resistance (PVR)|The exercise PVR at 20 Watts after study drug relative to the exercise PVR at 20 Watts in the initial assessment prior to study drug. This measurement is made by subtracting pulmonary capillary wedge pressure from the mean pulmonary arterial pressure and dividing by cardiac output in liters per minute and reported as wood units. A decrease in PVR measured by wood units would be considered a favorable response.|Baseline, 10 minutes after intervention during exercise||||wood units||Standard Deviation|Mean
2548233|NCT02885506|Secondary|Apparent Volume of Distribution During Terminal Phase After Oral Administration (Vz/F) (for Parent Only).|Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: Vz/F (for parent only).|During 11 days post administration of a single oral dose of P218 to healthy volunteers|Plasma concentration data were available from all completed cohorts for P218. Hence no data was analysed from the Pooled Placebo cohort.|||L||Standard Deviation|Mean
2548234|NCT02885506|Secondary|Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F) (for Parent Only)|Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: CL/F (for parent only)|During 11 days post administration of a single oral dose of P218 to healthy volunteers|Plasma concentration data were available from all completed cohorts for P218. Hence no data was analysed from the Pooled Placebo cohort.|||L/h||Standard Deviation|Mean
2548235|NCT02885506|Secondary|Elimination Half-life (t1/2)|Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: t1/2|During 11 days post administration of a single oral dose of P218 to healthy volunteers|Plasma concentration data were available from all completed cohorts for P218. Hence no data was analysed from the Pooled Placebo cohort.|||hours||Standard Deviation|Mean
2548236|NCT02885506|Secondary|Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax)|Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: Tmax|During 11 days post administration of a single oral dose of P218 to healthy volunteers|Plasma concentration data were available from all completed cohorts for P218. Hence no data was analysed from the Pooled Placebo cohort.|||hours||Standard Deviation|Mean
2548237|NCT02885506|Secondary|Maximum Plasma Drug Concentration (Cmax)|Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: Cmax|During 11 days post administration of a single oral dose of P218 to healthy volunteers|Plasma concentration data were available from all completed cohorts for P218. Hence no data was analysed from the Pooled Placebo cohort.|||ng/mL||Standard Deviation|Mean
2548238|NCT02885506|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)|Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: AUCinf|During 11 days post administration of a single oral dose of P218 to healthy volunteers|"Plasma concentration data available from all completed cohorts for P218. Hence no data analysed for Pooled Placebo cohort.~Subject 202 in cohort 2 (30 mg) reported a half-life estimate of 19.2 hours, considered outlying with regard to the remainder of the cohort with a geometric mean half-life of 3.13 hrs."|||h*ng/mL||Standard Deviation|Mean
2548239|NCT02885506|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUClast)|Estimation of the following PK parameter (in fasted and fed cohorts) using non-compartmental methods: AUClast|During 11 days post administration of a single oral dose of P218 to healthy volunteers|Plasma concentration data were available from all completed cohorts for P218. Hence no data was analysed from the Pooled Placebo cohort.|||ng.h/mL||Standard Deviation|Mean
2548240|NCT02885506|Primary|Safety and Tolerability of P218: Incidence, Severity and Relationship to the Investigational Product of Observed and Self-reported Adverse Events|Number of participants with adverse events|During 11 days post administration of a single oral dose of P218 to healthy volunteers|"In Part A, forty-two subjects received P218 at single doses of 10, 30, 100, 250, 500, 750 or 1000 mg and 14 subjects received placebo (two each per dose level).~In Part B, four subjects received a single dose of 250 mg when fasted in Period 1 and fed in Period 2, four other subjects received 250 mg when fed in Period 1 and fasted in Period 2."|||Participants|||Count of Participants
2548241|NCT02885246|Secondary|Number of Circulating Influenza B Lineage Positive Specimens Mismatch With the B-strain Vaccine Recommendation, Among the Number of Influenza B Positive Specimens, by Influenza Seasons|"Comparison of characteristics of the influenza B-infection Victoria (V) or Yamagata (Y) as observed in the database and the B-strain included in the trivalent influenza vaccine expressed as the number of cases with B-lineage-level mismatch between trivalent seasonal influenza vaccines and circulating viruses observed during the study period. Categories are defined as follows: e.g. for the first category:V.(B/Brisbane/60/2008)vsVictoria-May-Oct 2011 corresponds to Southern hemisphere influenza season of May-Oct 2011 with vaccine recommendation: Victoria (B/Brisbane/60/2008-like virus) compared to circulating Influenza B lineages Victoria. Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839."|Within the Southern hemisphere influenza seasons (May to October of each year 2011-2017)|The analysis was performed on the specimen samples, among the Total Cohort, diagnosed with seasonal influenza B, reported in the ICGES database of Panama, within the Southern hemisphere influenza seasons (May to October of each year 2011-2017).|||Participants|||Count of Participants
2548242|NCT02885246|Secondary|Number of Influenza Cases Caused by B- Strain and Presented by B-lineage and by Region Among All Influenza Cases A and/or B|The cases were stratified by lineage (Victoria and Yamagata) and region. Regions were classified as follows: West, Central, Panama, Northeast, Unspecified (= region unknown). Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.|From January 2011 to December 2017|The analysis was performed on the Total Cohort which included all specimen samples diagnosed with seasonal influenza A and/or B, reported in the ICGES database of Panama, from January 2011 to December 2017.|||Participants|||Count of Participants
2551612|NCT02813577|Secondary|Number of Participants With Freedom From All-cause Perioperative (≤ 30 Day) Death and Freedom From the Following: Index Limb Amputation, Index Limb Re-intervention, and Index-Limb-Related Death.||30 days post index procedure|Study was terminated.||||||
2548243|NCT02885246|Secondary|Number of Seasonal Influenza A and /or B Cases by Region, Within Study Period From 2011 to 2017|The cases were stratified by region. Regions were classified as follows: West, Central, Panama, Northeast, Unspecified (= region unknown). Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.|From January 2011 to December 2017|The analysis was performed on the Total Cohort which included all specimen samples diagnosed with seasonal influenza A and/or B, reported in the ICGES database of Panama, from January 2011 to December 2017.|||Participants|||Count of Participants
2548244|NCT02885246|Secondary|Number of Seasonal Influenza A and /or B Cases by Southern Hemisphere, Within Different Seasons From 2011 to 2017|The cases were stratified by influenza type and Southern hemisphere Influenza seasonal period (May-October of each year 2011-2017). Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.|Within the Southern hemisphere influenza seasons (May to October of each year 2011-2017)|The analysis was performed on the Total Cohort which included all specimen samples diagnosed with seasonal influenza A and/or B, reported in the ICGES database of Panama, within the Southern hemisphere influenza seasons (May to October of each year 2011-2017).|||Participants|||Count of Participants
2548245|NCT02885246|Secondary|Number of Cases With Laboratory Confirmed Diagnosis Seasonal Influenza A and/or B Who Experienced Outcomes (Complications)|The outcomes were categorized as follows: Outpatient, Hospitalised, Dead or Unspecified (i.e. missing data on the epidemiology surveillance form). Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.|From January 2011 to December 2017|The analysis was performed on the Total Cohort which included specimen samples diagnosed with seasonal influenza A and/or B, reported in the ICGES database of Panama, from January 2011 to December 2017.|||Participants|||Count of Participants
2548246|NCT02885246|Secondary|Number of Cases With Laboratory Confirmed Diagnosis Seasonal Influenza A and/or B Who Experienced Clinical Features (Clinical Symptoms)|The signs and symptoms assessed were: Fever, Cough, Sore throat, Rhinorrhea, Dyspnea, Vomiting, Diarrhea, Myalgias, Nausea, Headache, Wheezing, Apnea, Tachypnea, Polypnea, Arthralgia, Chest Pain, Convulsion, Hyporexia, Weakness, Irritability, Odynophagia, Abdominal pain, Conjunctivitis, Cyanosis and Chills. Each sign and symptom was assessed in four categories: yes = presence of sign/symptom; no = absence of sign/symptom; form not filled = no epi surveillance form available; and unspecified= no data on the Epi surveillance form. Analysis related to duration of the illness was not performed as the data was not collected. Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.|From January 2011 to December 2017|The analysis was performed on the Total Cohort which included all specimen samples diagnosed with seasonal influenza A and/or B, reported in the ICGES database of Panama, from January 2011 to December 2017.|||Participants|||Count of Participants
2548247|NCT02885246|Primary|Number of Seasonal Influenza B Cases by Strain Lineage, in Panama (Using the Data Reported Via National Influenza Surveillance Program) Among All Influenza Cases A and/or B|The case definition of Influenza was any clinical specimen confirmed by a positive laboratory test. Cases were stratified by lineage (Victoria and Yamagata) and the following age categories: less than (<) 2 years; 2-4 years; 5-19 years; 20-39 years; 40-59 years; greater than of equal to (≥) 60 years. Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.|From January 2011 to December 2017|The analysis was performed on the Total Cohort which included all specimen samples diagnosed with seasonal influenza A and/or B, reported in the ICGES database of Panama, from January 2011 to December 2017.|||Participants|||Count of Participants
2548248|NCT02885246|Primary|Number of Seasonal Influenza A Cases by Virus Subtypes, in Panama (Using the Data Reported Via National Influenza Surveillance Program) Among All Influenza Cases A and/or B|The case definition of Influenza was any clinical specimen confirmed by a positive laboratory test. Cases were stratified by virus subtype (H1N1 and H3N2) and the following age categories: less than (<) 2 years; 2-4 years; 5-19 years; 20-39 years; 40-59 years; greater than of equal to (≥) 60 years. Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.|From January 2011 to December 2017|The analysis was performed on the Total Cohort which included all specimen samples diagnosed with seasonal influenza A and/or B, reported in the ICGES database of Panama, from January 2011 to December 2017.|||Participants|||Count of Participants
2548249|NCT02885246|Primary|Number of Seasonal Influenza A and /or B Cases by Age Group, in Panama (Using the Data Reported Via National Influenza Surveillance Program)|The case definition of Influenza was any clinical specimen confirmed by a positive laboratory test. Cases were stratified by the following age categories: less than (<) 2 years; 2-4 years; 5-19 years; 20-39 years; 40-59 years; greater than of equal to (≥) 60 years and Unspecified age, instead of <1, 1-4, 5-9, 10-14, 15-19, 20-24, 25-44, 45-49, 50-59, 60-64 and ≥ 65 years, as initially described in the Protocol. Note that one specimen sample was positive for both influenza A and B so the number started still remains 1839.|From January 2011 to December 2017|The analysis was performed on the Total Cohort which included all specimen samples diagnosed with seasonal influenza A and/or B, reported in the ICGES database of Panama, from January 2011 to December 2017.|||Participants|||Count of Participants
2548250|NCT02885181|Secondary|Change From Baseline in The Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a self-reported tool used to assess the ability to perform tasks in 8 functional categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional category were collected as 0 (without any difficulty) to 3 (unable to do a task in that area). The HAQ-DI score ranges from 0 (no disability) to 3 (completely disabled), when 6 or more categories are non-missing.|Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2548251|NCT02885181|Secondary|Percentage of Participants Who Achieved ACR70 Improvement at Week 12|ACR70 response was defined as having ≥ 70% improvement from baseline in the number of tender and the number of swollen joints, and a 70% improvement in at least 3 of the following 5 criteria: PhGA, PtGA, Participant's pain assessment, HAQ-DI score, and CRP.|Week 12|Full Analysis Set|||percentage of participants|||Number
2548252|NCT02885181|Secondary|Percentage of Participants Who Achieved ACR50 Improvement at Week 12|ACR50 response was defined as having ≥ 50% improvement from baseline in the number of tender and the number of swollen joints, and a 50% improvement in at least 3 of the following 5 criteria: PhGA, PtGA, Participant's pain assessment, HAQ-DI score, and CRP.|Week 12|Full Analysis Set|||percentage of participants|||Number
2548253|NCT02885181|Secondary|Percentage of Participants Who Achieved American College of Rheumatology (ACR)20 Improvement at Week 12|American College of Rheumatology (ACR)20 response was defined as having ≥ 20% improvement from baseline in the number of tender and the number of swollen joints, and a 20% improvement in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity (PhGA), Participant's Global Assessment of Disease Activity (PtGA), Participant's pain assessment, Participant's assessment of physical function (HAQ-DI) score, and C-reactive protein (CRP).|Week 12|Full Analysis Set|||percentage of participants|||Number
2548254|NCT02885181|Primary|Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) at Week 12|Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity) and C-Reactive Protein (CRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|Baseline; Week 12|Participants in the Full Analysis Set (participants who received at least 1 dose of study drug) with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2548255|NCT02885012|Secondary|Disease Status as Measured by Change in Biomarker|NT-proBNP Biomarker: BNP is released from cardiac cells in response to increased pressure. The higher the value the worse the disease status.|Baseline and 12 Weeks|Neither subject in group 2 completed week 24 assessment for this outcome so we are reporting changes at week 12 compared to baseline.|||pg/mL||Standard Deviation|Mean
2548256|NCT02885012|Secondary|Change in EmPHasis-10 Score|Questionnaire-. The questionnaire is designed to determine how pulmonary hypertension affects the patient's life by asking 10 questions which address breathlessness, fatigue, control, and confidence. emPHasis-10 consists of 10 items which address breathlessness, fatigue, control and confidence. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life.|Baseline and 24 Weeks|Second patient in second arm did not complete questionnaire in week 24|||units on a scale||Standard Deviation|Mean
2548257|NCT02885012|Primary|Change in Stroke Volume|Echocardiography is used to estimate the stroke volume, or the amount of blood ejected from the heart with each beat. An average over three beats is used for the estimate and is reported as ml/beat.|Baseline and 24 Weeks||||ml/beat||Standard Deviation|Mean
2548258|NCT02884492|Primary|18F-THK-5351 Standardized Uptake Value Ratio|The standardize uptake value ratio is the concentration of radioactivity measured from the 18F-THK-5351 PET scan in the posterior cingulate gyrus, divided by that in the cerebellar gray matter (the reference region, which is expected to be devoid of tau pathology). This ratio is a relative measure of 18F-THK-5351 binding, and therefore of tau pathology, in brain tissue. PET image data was acquired from 50 min post-injection to 70 min post-injection of 18F-THK-5351.|PET image data collected 50 min post-injection to 70 min post-injection of 18F-THK-5351||||Standardized uptake value ratio||Full Range|Median
2548259|NCT02884427|Secondary|Difference of Maximum Grip Strength for Females|The difference in maximum grip strength for females is that value in kilograms obtained between the best score of the first three gripping attempts made before the intervention compared to the best result obtained from the three attempts after the intervention considering only the women of each group. Maximum force difference will express the force changes before and after the participants are exposed to one of the treatments.|Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.||||Kilograms (Kg)||Standard Deviation|Mean
2548260|NCT02884427|Secondary|Difference of Maximum Grip Strength for Males|The difference in maximum grip strength for males is that value in kilograms obtained between the best score of the first three gripping attempts made before the intervention compared to the best result obtained from the three attempts after the intervention considering only the men of each group. Maximum force difference will express the force changes before and after the participants are exposed to one of the treatments.|Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.||||Kilograms (Kg)||Inter-Quartile Range|Median
2548261|NCT02884427|Primary|Difference of Maximum Grip Strength|The difference in maximum grip strength is that value in kilograms obtained between the best score of the first three gripping attempts made before the intervention compared to the best result obtained from the three attempts after the intervention. The maximum force difference will express the force changes before and after the participants are exposed to one of the treatments.|Baseline and 1 hours later (1 session of treatment), assessed as up to 1 month.||||Kilograms (Kg)||Standard Deviation|Mean
2548262|NCT02884089|Secondary|Pharmacokinetics (PK): Renal Clearance (CLr) of Iohexol|Pharmacokinetics (PK): Renal Clearance (CLr) of Iohexol was evaluated.|Pre infusion, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 hours post infusion|All randomized participants who received at least one dose of study Abemaciclib or placebo along with Iohexol & had evaluable PK data.|||Milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
2548263|NCT02884089|Primary|Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin|Pharmacokinetics (PK): Renal Clearance (CLr) of Metformin was evaluated.|Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose|All randomized participants who received at least one dose of study Abemaciclib or placebo along with Metformin and had evaluable PK data.|||Liters per Hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2548264|NCT02884089|Primary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Metformin was evaluated.|Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose|All randomized participants who received at least one dose of study Abemaciclib or placebo along with Metformin and had evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2548265|NCT02884089|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Metformin|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of Metformin was evaluated.|Pre dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36 hours (h) post dose|All randomized participants who received at least one dose of study Abemaciclib or placebo along with Metformin and had evaluable PK data.|||Nanogram*Hour per Milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2548267|NCT02883244|Secondary|Change in Gingivitis by Bleeding on Probing at 28 Days|Presence or absence of bleeding within 10 seconds after probing shall be scored at 6 sites per tooth: distobuccal, distal, mesiobuccal, and distolingual, lingual and mesiolingual surfaces. The number of sites where bleeding is recorded is divided by the total number of available sites and multiplied by 100 to express the bleeding on probing as a percentage. Change = (28 days percentage - Baseline percentage)|Baseline and 28 days||||percentage of Bleeding on Probing||Standard Deviation|Mean
2548268|NCT02883244|Secondary|Change in Gingivitis by UNC Modified Gingival Index at 28 Days|Gingiva shall be assessed at 6 sites per tooth: distobuccal, direct buccal, mesiobuccal, distolingual, direct lingual and mesiolingual surfaces (Scale is 0-3: 0 =Normal gingiva (pink, firm, stippled), 3 =Severe inflammation: marked redness and edema, ulceration, tendency to spontaneous bleeding). Change = (28 days Score - Baseline Score)|Baseline and 28 days||||units on a scale||Standard Deviation|Mean
2548269|NCT02883244|Secondary|Performance (Easy to Use) of an Assigned Product|Subjects record product performance and experience on a diary. Scale of Easy to Use was scored from 1 to 5 (1= Not easy; 5= Very easy).|28 days||||score on a scale||Standard Deviation|Mean
2548270|NCT02883244|Primary|Change in Interproximal Plaque by Modification of the Quigley-Hein Plaque Index at 28 Days|Plaque scores shall be visually assessed at the four (2) tooth surfaces that make up each of the 12 (6 per side) qualifying interproximal test units: mesiobuccal and distobuccal (scale of 0-5, 0 =No debris or stain present on the clinical crown; 5=Plaque coverage over more than two third of the tooth surface) Change = (28 days Score - Baseline Score)|Baseline and 28 days||||score on a scale||Standard Deviation|Mean
2548271|NCT02883244|Primary|Change in Interproximal Plaque by Modification of the Quigley-Hein Plaque Index at 14 Days|Plaque scores shall be visually assessed at the four (2) tooth surfaces that make up each of the 12 (6 per side) qualifying interproximal test units: mesiobuccal and distobuccal (scale of 0-5, 0 =No debris or stain present on the clinical crown; 5=Plaque coverage over more than two third of the tooth surface). Change = (14 days Score - Baseline Score)|Baseline and 14 days||||score on a scale||Standard Deviation|Mean
2548272|NCT02882854|Secondary|PACU Length of Stay in Minutes||Time frame between arrival and discharge in PACU, approximately 90 minutes||||minutes||Inter-Quartile Range|Median
2548273|NCT02882854|Secondary|Number of Doses of PONV Treatment Administered in PACU||Time frame between arrival and discharge in PACU, approximately 90 minutes|Data missing for1 participants in the placebo group and 1 participant in the Guanfacine group.|||Participants|||Count of Participants
2548274|NCT02882854|Secondary|Total Narcotic Requirement in PACU|Total narcotic requirement in PACU tallied in morphine equivalents during PACU stay|Time frame between arrival and discharge in PACU, approximately 90 minutes|Data was not available for 1 participant in the placebo group.|||morphine equivalents||Inter-Quartile Range|Median
2548275|NCT02882854|Secondary|Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)|Postoperative pain assessment using VAS at 24 hours postop when 0 is no pain and 10 is worst pain|24 hours postop|Based on only 71 participants to post operative questionnaire.|||score on a scale||Inter-Quartile Range|Median
2548276|NCT02882854|Secondary|Maximum Postoperative Pain Assessment Using 11-point Visual/Verbal Analog (VAS)|Maximum postoperative pain assessment assessed in PACU at 15, 30 and 60 minutes after PACU arrival using VAS when 0 is no pain and 10 is worst pain|15, 30, 60 minutes after arriving in PACU|Data unavailable for 2 participants in the placebo group at 15 minute time point, 1 participant in the placebo group at the 30 minute time point,|||Participants|||Count of Participants
2548277|NCT02882854|Primary|Postoperative Nausea Assessment Using 11-point Nausea Scale (nVRS)|PONV assessed using nVRS at 24 hours postop when 0 is no nausea and 10 is worst nausea.|24 hours post op|Only 70 patients (32 in guanfacine arm; 38 in placebo arm) responded to follow-up phone call and provided PONV data at the 24 hour timepoint.|||score on a scale||Inter-Quartile Range|Median
2548278|NCT02882854|Primary|Comparison of PONV Score of Assessments Done at 60 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)|Comparison of PONV Score of assessments done at 60 minutes after arrival in PACU using the nVRS when 0 is no nausea and 10 is worst nausea|60 minutes after arriving in PACU|nVRS data was not available for 1 participant in the Guanfacine group|||Participants|||Count of Participants
2548279|NCT02882854|Primary|Comparison of PONV Score of Assessments Done at 30 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)|Comparison of PONV Score of assessments done at 30 minutes after arrival in PACU using the nVRS when 0 is no nausea and 10 is worst nausea|30 minutes after arriving in PACU||||Participants|||Count of Participants
2548280|NCT02882854|Primary|Comparison of PONV Score of Assessments Done at 15 Minutes After Arrival in PACU Using 11-point Nausea Scale (nVRS)|Comparison of PONV Score of assessments done at 15 minutes after arrival in PACU using the nVRS when 0 is no nausea and 10 is worst nausea|15 minutes after arriving in PACU|15 minute nVRS datapoint was not available for 2 participants in the Placebo group|||Participants|||Count of Participants
2548281|NCT02882633|Secondary|Quality of Recovery|Score of QoR survey to determine recovery status. 0-18 where 0 is the worst and 18 is the best feeling.|Change from baseline through 24 hours||||Score on a scale||Inter-Quartile Range|Mean
2548282|NCT02882633|Primary|Amount of Opiate Consumption|Participants need for pain relief as measured by opiate consumption|While in PACU. An average length of stay for Lumbar Plexus Block group was 165.04 min and 139.72 min for Fascia Iliaca Block group.||||mg||Inter-Quartile Range|Mean
2548283|NCT02882633|Primary|Pain Score Change|Change in pain scores, as measured by the Visual Analog Scale (0-10). 10 is worst imaginable pain and 0 means no pain at all.|Change from baseline through 15 minutes||||change in score on a scale||Inter-Quartile Range|Mean
2548284|NCT02882152|Secondary|Postoperative Bleeding|Postoperative bleeding volume (ml)|baseline (discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours||||mL||Standard Deviation|Mean
2548285|NCT02882152|Primary|Analgesic Efficacy|Pain with verbal numeric rating scale (VNRS). VNRS has 11 points, from zero to 10 (zero= no pain, 1-3 = mild pain, 4-5 = moderate pain, 7-9 = severe pain, 10 = unbearable pain).|baseline (zero hour: discharge of post-anesthesia care unit-PACU), 24hs, 48hs, 72 hours||||units on a scale||Standard Deviation|Mean
2548286|NCT02881840|Primary|Mass Balance|Mean recovery of radioactivity in excreta after a single intravenous (IV) dose of carbon-14-labelled APD421|168 hours||||percent excreted||Full Range|Mean
2548287|NCT02881775|Secondary|Intra Cortical Facilitation (ICF)|Transcranial magnetic stimulation (TMS), using the conditioning-test paired-pulse paradigm with a 15 ms interval, will be used. ICF is the ratio of the conditioning stimulus relative to the test stimulus. A ratio > 1.0 indicates facilitation.|Within 1 hour post intervention|4 subjects withdrew from the study after the baseline measures. This left 16 subjects for the intervention arm of the study. A technical issue in how the TMS unit worked was discovered after collecting the first 4 subjects in the intervention part of the study. This impacted their AMT-MEP, ICF, and SICI data which were excluded from the analyses.|||ratio||Standard Error|Least Squares Mean
2548288|NCT02881775|Secondary|Short Interval Cortical Inhibition (SICI)|Transcranial magnetic stimulation (TMS), using the conditioning-test paired-pulse paradigm with a 3 ms interval, will be used. SICI is the ratio of the conditioning stimulus relative to the test stimulus. A ratio < 1.0 indicates inhibition.|Within 1 hour post intervention|4 subjects withdrew from the study after the baseline measures. This left 16 subjects for the intervention arm of the study. A technical issue in how the TMS unit worked was discovered after collecting the first 4 subjects in the intervention part of the study. This impacted their AMT-MEP, ICF, and SICI data which were excluded from the analyses.|||ratio||Standard Error|Least Squares Mean
2548289|NCT02881775|Secondary|Active Motor Threshold Motor Evoked Potential (AMT-MEP)|The quadriceps active muscle responses (motor evoked potentials) that result from the single-pulse transcranial magnetic stimulation (TMS) pulses over the motor cortex. These AMT-MEP are measured peak-to-peak in microvolts (uV ). 10 AMT-MEP values were collected and averaged.|Within 1 hour post intervention|4 subjects withdrew from the study after the baseline measures. This left 16 subjects for the intervention arm of the study. A technical issue in how the TMS unit worked was discovered after collecting the first 4 subjects in the intervention part of the study. This impacted their AMT-MEP, ICF, and SICI data which were excluded from the analyses.|||uV||Standard Error|Least Squares Mean
2548290|NCT02881775|Secondary|Timed Up & Go (TUG)|Time in seconds to rise from a chair, walk 3 m, return and sit down|Within 1 hour post intervention|4 subjects withdrew from the study after the baseline measures. This left 16 subjects for the intervention arm of the study.|||seconds||Standard Error|Least Squares Mean
2548291|NCT02881775|Secondary|Pressure Pain Threshold (PPT) - Medial Knee|Using the AlgoMed algometer, pressure at a rate of 35 kPA/second is applied to the medial knee to the level that subject indicates is painful. Units of measure are kilopascal (kPa)|Within 1 hour post intervention|4 subjects withdrew from the study after the baseline measures. This left 16 subjects for the intervention arm of the study.|||kPa||Standard Error|Least Squares Mean
2548292|NCT02881775|Secondary|Numeric Pain Rating Scale (NPRS) Score|Pain intensity is rated on a visual analog scale of 0-10 where 0 is no pain and 10 is maximum pain|Within 1 hour post intervention|4 subjects withdrew from the study after the baseline measures. This left 16 subjects for the intervention arm of the study. For two subjects, the research assistant missed obtaining the post-intervention pain rating.|||score on scale||Standard Error|Least Squares Mean
2548293|NCT02881775|Primary|Quadriceps Maximal Voluntary Isometric Contraction (MVIC)|HUMAC NORM electromechanical dynamometer is used to measure isometric torque generation in quadriceps muscle stabilized with 70 degrees of knee flexion. Units of measure are in Newton meters (Nm).|Within 1 hour post intervention|4 subjects withdrew from the study after the baseline measures. This left 16 subjects for the intervention arm of the study.|||Nm||Standard Error|Least Squares Mean
2548294|NCT02881775|Primary|Quadriceps Central Activation Ratio (CAR)|Quadriceps Central Activation Ratio (CAR) is a percentage of the amount of torque produced during the superimposed burst technique using maximal voluntary isometric contraction (MVIC) and superimposed burst torque. It is reported on a scale of 0 (worst) to 100% (best) activation.|Within 1 hour post intervention|4 subjects withdrew from the study after the baseline measures. This left 16 subjects for the intervention arm of the study. Four subjects declined to perform the test after the experience with the electrical stimulus in the baseline session.|||% activation||Standard Error|Least Squares Mean
2548295|NCT02881658|Secondary|Changes of Musculoskeletal-related Traits Via Measuring Centre of Pressure Excursion Index for Left and Right Foot at Baseline and Week 3|centre of pressure excursion index = CPEI|From baseline to week 3||||Percentage of Change||Inter-Quartile Range|Median
2548296|NCT02881658|Secondary|Changes of Musculoskeletal-related Traits Via Measuring 6 Metres Gait Speed at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
2548297|NCT02881658|Secondary|Changes of Musculoskeletal-related Traits Via Measuring Peak Expiratory Flow Rate at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
2548298|NCT02881658|Secondary|Changes of Musculoskeletal-related Traits Via Measuring Bio-Impedance at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
2548299|NCT02881658|Secondary|Changes of Musculoskeletal-related Traits Via Measuring Hand Grip Strength at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
2548300|NCT02881658|Secondary|Changes of Cardiometabolic Risk Factors Via Measuring Body Temperature at Baseline and Week 3||From baseline to week 3||||percentage of body temperature change||Inter-Quartile Range|Median
2548301|NCT02881658|Secondary|Changes of Cardiometabolic Risk Factors Via Measuring Blood Pressure at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
2548302|NCT02881658|Secondary|Changes of Cardiometabolic Risk Factors Via Measuring Anthropometry at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
2548303|NCT02881658|Secondary|Changes of Fasting Blood Glucose Via Blood Test at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
2548304|NCT02881658|Secondary|Change of Serum Creatinine Via Blood Test at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
2548305|NCT02881658|Secondary|Change of Triglycerides (TAG) Via Blood Test at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
2548306|NCT02881658|Secondary|Change of Total Cholesterol Via Blood Test at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
2548307|NCT02881658|Secondary|Change of High-density Lipoprotein Cholesterol (HDL-C) Via Blood Test at Baseline and Week 3||From baseline to week 3||||percentage of change||Inter-Quartile Range|Median
2548309|NCT02881658|Primary|Mean of Serum Low-density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3||From baseline to week 3|All 201 subjects were included in the population, but certain blood test result on LDL-C were not available, thus difference in the overall number of participants analyzed and the actual number of participants included to present the mean value.|||mmol/L||Standard Deviation|Mean
2548310|NCT02881567|Secondary|Number of Participants With Clinically Relevant Shifts in Laboratory Assessments|Clinical Laboratory assessments were tests of Chemistry and Hematology. The investigator determined if any of the laboratory results were clinically relevant shifts from Baseline.|First dose of study drug to within 30 days of last dose (up to 11 months)|Safety Population included all enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2548311|NCT02881567|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death or in the view of the Investigator, places the participant at immediate risk of death or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability or results in a birth defect.|First dose of study drug to within 30 days of last dose (up to 11 months)|Safety Population included all enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2548312|NCT02881567|Secondary|Permanent Discontinuation Rate of Daclizumab at Month 12|Permanent Discontinuation Rate was calculated as the ratio of number of participants who had permanently discontinued daclizumab prior to Month 12 over the total number of participants who received at least 1 dose of daclizumab in the study.|Month 12|The study was terminated. No participants reached the 12-month time point.||||||
2548313|NCT02881567|Secondary|Number of Participants With New and Newly Enlarged T2 Hypointense Lesions at Months 6 and 12|New and newly enlarged T2 Hypointense Lesions were measured by MRI.|Months 6 and 12|FAS included all participants enrolled in the study. Number Analyzed is the number of participants with available assessment. No participants reached the 12-month time point since the study was terminated.|||Participants|||Count of Participants
2548314|NCT02881567|Secondary|Number of Participants With New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions at Months 6 and 12|New Gadolinium-Enhanced (Gd+) and T1 Hypointense Lesions were assessed using magnetic resonance imaging (MRI).|Months 6 and 12|FAS included all participants enrolled in the study. Number Analyzed is the number of participants with available assessment. No data was collected for T1 Hypointense Lesions at Month 6. No participants reached the 12-month time point since the study was terminated.|||Participants|||Count of Participants
2548315|NCT02881567|Secondary|Annualized Relapse Rate (ARR) at Month 12|Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of Month 12, and the ratio then multiplied by 365.|Month 12|The study was terminated. No participants reached the 12-month time point.||||||
2548316|NCT02881567|Secondary|Percentage of Participants Experiencing Relapse Requiring Hospitalization and/or Steroid Treatment at Month 12|Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.|Month 12|The study was terminated. No participants reached the 12-month time point.||||||
2548317|NCT02881567|Secondary|Percentage of Participants Relapse-free at Month 12|Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.|Month 12|The study was terminated. No participants reached the 12-month time point.||||||
2548318|NCT02881567|Primary|Percentage of Participants Relapse-free at Month 6|Relapses were defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The Kaplan-Meier estimate of the percentage of participants relapse-free at Month 6 is reported.|Month 6|FAS included all participants enrolled in the study.|||percentage of participants|||Number
2548319|NCT02881112|Primary|Pain Intensity Assessment|Change in Pain from Baseline/Pre-treatment to End of Treatment/Last Available Observation. Pain captured using NPRS, 0-10 scale were 0 = no pain and 10 = worst pain, given to subjects as part of a daily diary.|Pain scores collected daily, up to 20 weeks.|Subjects recording both a Baseline and End of Study score were included in the NPRS analysis.|||score on a scale||Standard Deviation|Mean
2548320|NCT02881047|Primary|Number of Subjects Who Show Decrease in Skin Thickness and Sclerosis With Collagen Remodeling as Measured by Before and After Skin Biopsies Biopsy|Trichcrome stain, collagen fiber number and thickness, Herovici stain, elastic fiber length, and dermal thickness.|baseline and 3 months after final laser session||||Participants|||Count of Participants
2548321|NCT02881047|Primary|Number of Subjects With Evidence of Collagen Remodeling (Increased Dermal Echogenicity) Compared to Baseline|Measurement of skin echogencity (brightness) in comparison with pre-therapy images of the same areas using high-resolution ultrasound.|3 months after final laser session (5 months after time zero / baseline)||||Participants|||Count of Participants
2548322|NCT02881047|Primary|Number of Subjects Who Show Improvement in Range of Motion, Flexion, and Extension|Range of motion (flexion, extension, supination, pronation) of the target joint (measured in degrees, using a goniometer).|5 months from time point zero / baseline||||Participants|||Count of Participants
2548323|NCT02881008|Secondary|Proportion of Patients With Biochemical Response at 24 Weeks of Therapy|Biochemical response is defined as normalization of ALT level at week 24 compared to baseline.|24 weeks|This variable was assessed in the patients administered 24-week treatment: patients of Arm F who received Myrcludex B 10 mg and patients of Arm D who received Entecavir 0.5 mg. Only patients with abnormal ALT levels at baseline were included in data analysis.|||Participants|||Count of Participants
2552244|NCT02797522|Primary|Pharmacokinetics of ARC-521 Injection: Apparent Volume of Distribution (V), Healthy Volunteers||Through 48 hours post-dose on Day 1|Analysis was not planned or conducted per SAP due to study termination.||||||
2548324|NCT02881008|Secondary|Proportion of Patients With HBV DNA Response at Week 24 of Therapy|HBV DNA response is defined as persistent reduction of HBV DNA by >1 log IU/ml or negativation at week 24 compared to baseline.|24 weeks|This variable was assessed in the patients administered 24-week treatment: patients of Arm F who received Myrcludex B 10 mg and patients of Arm D who received Entecavir 0.5 mg.|||Participants|||Count of Participants
2548325|NCT02881008|Secondary|Proportion of Patients With cccDNA Response at 24 Week of Therapy|Virological cccDNA response is defined as reduction of intrahepatic cccDNA by 0.5 logs in comparison to baseline at week 24.|24 weeks|Virological cccDNA response was to be estimated only for patients of group F administered 24-week therapy with Myrcludex B in the dose of 10 mg and to whom liver biopsy during screening period and at week 24 was performed.|||Participants|||Count of Participants
2548326|NCT02881008|Secondary|Proportion of Patients With Biochemical Response at 12 Weeks of Therapy|Biochemical response is defined as normalization of ALT level at week 12 compared to baseline.|12 weeks|Only patients with abnormal ALT levels at baseline were included in data analysis.|||Participants|||Count of Participants
2548327|NCT02881008|Secondary|Proportion of Patients With HBV DNA Response at Week 12 of Therapy|HBV DNA response is defined as persistent reduction of HBV DNA by >1 log IU/ml or negativation at week 12 compared to baseline.|12 weeks|For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.|||Participants|||Count of Participants
2548328|NCT02881008|Secondary|Proportion of Patients With HBsAg Response at 24 Week of Therapy|HBsAg response is defined as serum HBsAg decline of at least 0.5 logs IU/ml (or HBsAg negativation) at week 24 compared to baseline.|24 weeks|This variable was assessed in the patients administered 24-week treatment: patients of Arm F who received Myrcludex B 10 mg and patients of Arm D who received Entecavir 0.5 mg.|||Participants|||Count of Participants
2548329|NCT02881008|Primary|Proportion of Patients With HBsAg Response at 12 Week of Therapy|HBsAg response is defined as serum HBsAg decline of at least 0.5 logs IU/ml (or HBsAg negativation) at week 12 compared to baseline.|12 week|For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.|||Participants|||Count of Participants
2548330|NCT02880852|Secondary|Percent Change From Baseline to Day 84 in Immunoglobulins B Cell Subset (Normalized [Norm] CD19+/27BRIGHT[Br]/38Br SLE Subset, Norm CD20+/138+Plasmacytoid, Norm CD20+/69+Activated and Norm CD20-/CD138+Plasma Cell) for Pharmacodynamic Assessment|Immunoglobulin B cell subset inlcuded Norm CD19+/27Br/38Br SLE subset, Norm CD20+/138+plasmacytoid, Norm CD20+/69+activated and Norm CD20-/CD138+plasma cell. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. Percent change from Baseline was calculated as 100 multiplied by [(Post-Baseline Visit Value minus Baseline) / Baseline].|Baseline (pre-dose on Day 0) to Day 84|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|||Percent change||Standard Deviation|Mean
2548331|NCT02880852|Secondary|Percent Change From Baseline to Day 84 in B Cell Subsets (CD20+/27+ Memory and CD20+/27-naïve) for the Pharmacodynamic Assessment|Immunoglobulin B cell subset included CD20+/27+ memory and CD20+/27-naïve. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. Percent change from Baseline was calculated as 100 multiplied by [(Post-Baseline Visit Value minus Baseline) / Baseline].|Baseline (pre-dose on Day 0) to Day 84|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|||Percent change||Standard Deviation|Mean
2548332|NCT02880852|Secondary|Percent Change From Baseline to Day 84 in B Cell Subsets (Cluster of Differentiation [CD]19 and CD 20+) for Pharmacodynamic Assessment|Immunoglobulin B cell subsets included CD19 and CD 20+. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value. Percent change from Baseline was calculated as 100 multiplied by [(Post-Baseline Visit Value minus Baseline) / Baseline]. Pharmacodynamic population comprised of participants who received the study medication and for whom pharmacodynamic data was available.|Baseline (pre-dose on Day 0) to Day 84|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|||Percent change||Standard Deviation|Mean
2548333|NCT02880852|Secondary|Number of Participants With Positive Urinalysis Dipstick Results|Urinalysis was done by the dipstick method to detect the presence of protein, glucose, ketones and occult blood in urine. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine occult blood, urine protein and urine ketones can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample; results for urinalysis parameter of urine glucose can be read as negative, Trace, 1+ or 1/4 gram per Liter (g/L), 2+ or 1/2 g/L, 3+ or 1 g/L and 4+ indicating proportional concentrations in the urine sample. *a indicates two participants did not take the urinalysis test at Day 14 on scheduled date but took an unscheduled sample at the next visit (Day 21) and *b indicates one participant did not take the urinalysis test at Day 28 on scheduled date but took an unscheduled sample at the next visit (Day 42). Only those participants with positive results have been presented.|Day 0 (24 hours), Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84|Safety Population.|||Participants|||Count of Participants
2548334|NCT02880852|Secondary|Change From Baseline to Day 84 in Hematology Parameter- Hemoglobin|Hematology parameter included hemoglobin. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.|Baseline (pre-dose on Day 0) to Day 84|Safety Population.|||Grams per Liter (g/L)||Standard Deviation|Mean
2548335|NCT02880852|Secondary|Change From Baseline to Day 84 in Hematology Parameter- Hematocrit|Hematology parameter included hematocrit. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.|Baseline (pre-dose on Day 0) to Day 84|Safety Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
2548336|NCT02880852|Secondary|Change From Baseline to Day 84 in Hematology Parameter- Erythrocytes|Hematology parameter included erythrocytes. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.|Baseline (pre-dose on Day 0) to Day 84|Safety Population.|||10^12 cells/Liter||Standard Deviation|Mean
2548460|NCT02877732|Primary|Reliability of EYE-SYNC Data|The integrity will be analyzed based on the score obtained from EYE-SYNC device.|Immediate post impact, 2 days, 7 days and 14 days post impact.|Study was cancelled by the funder prior to collection of any outcome data; only screening procedures were performed.||||||
2548337|NCT02880852|Secondary|Change From Baseline to Day 84 in Hematology Laboratory Parameters- Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets|Hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.|Baseline (pre-dose on Day 0) to Day 84|Safety Population.|||10^9 cells/Liter||Standard Deviation|Mean
2548338|NCT02880852|Secondary|Change From Baseline to Day 84 in Clinical Chemistry Parameters- Calcium, Calcium Corrected, Carbon Dioxide, Chloride, Magnesium, Phosphate, Potassium, Sodium, Urea and Glucose|Clinical chemistry parameters included calcium, calcium corrected, carbon dioxide, chloride, magnesium, phosphate, potassium, sodium, urea and glucose. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.|Baseline (pre-dose on Day 0) to Day 84|Safety Population.|||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
2548339|NCT02880852|Secondary|Change From Baseline to Day 84 in Clinical Chemistry Parameters- Bilirubin, Creatinine, Direct Bilirubin, Indirect Bilirubin and Urate|Clinical chemistry parameters included bilirubin, creatinine, direct bilirubin, indirect bilirubin and urate. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.|Baseline (pre-dose on Day 0) to Day 84|Safety Population.|||Micromoles per Liter (µmol/L)||Standard Deviation|Mean
2548340|NCT02880852|Secondary|Change From Baseline to Day 84 in Clinical Chemistry Parameters- Albumin and Protein|Clinical chemistry parameters included albumin and protein. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.|Baseline (pre-dose on Day 0) to Day 84|Safety Population.|||Grams per liter (g/L)||Standard Deviation|Mean
2548341|NCT02880852|Secondary|Change From Baseline to Day 84 in Clinical Chemistry Parameters- Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase|Clinical chemistry parameters included ALT, ALP, AST, GGT and lactate dehydrogenase. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.|Baseline (pre-dose on Day 0) to Day 84|Safety Population.|||International units per Liter (IU/L)||Standard Deviation|Mean
2548342|NCT02880852|Secondary|Number of Participants With Abnormal-clinically Significant 12-lead Electrocardiogram (ECG) Findings|ECG parameters included heart rate, PR interval, QRS interval, QT interval and corrected QT (QTc) interval. Number of participants with abnormal-clinically significant 12-lead ECG findings are presented.|Up to Day 84|Safety Population.|||Participants|||Count of Participants
2548343|NCT02880852|Secondary|Change From Baseline to Day 84 in Vital Sign- Temperature|Vital signs included temperature. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.|Baseline (pre-dose on Day 0) to Day 84|Safety Population.|||Celsius||Standard Deviation|Mean
2548344|NCT02880852|Secondary|Change From Baseline to Day 84 in Vital Sign- Pulse Rate|Vital signs included pulse rate. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.|Baseline (pre-dose on Day 0) to Day 84|Safety Population.|||Beats per minute||Standard Deviation|Mean
2548345|NCT02880852|Secondary|Change From Baseline to Day 84 in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital signs included SBP and DBP. SBP and DBP were measured with the participant in the sitting position. Baseline was pre-dose on Day 0. Change from Baseline was defined as the post-Baseline value minus the Baseline value.|Baseline (pre-dose on Day 0) to Day 84|Safety Population|||Millimeters of mercury||Standard Deviation|Mean
2548346|NCT02880852|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant, or associated with liver injury and impaired liver function.|Up to Day 84|Safety Population.|||Participants|||Count of Participants
2548347|NCT02880852|Primary|Volume of Distribution (Vz) of Belimumab|Blood samples were collected at the indicated time points to calculate Vz of belimumab.|Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose|PK Parameter Population|||Milliliters/kilogram||Geometric Coefficient of Variation|Geometric Mean
2548348|NCT02880852|Primary|Systemic Clearance (CL) of Belimumab|Blood samples were collected at the indicated time points to calculate CL of belimumab.|Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose|PK Parameter Population|||(Milliliters/day)/kilogram||Geometric Coefficient of Variation|Geometric Mean
2548349|NCT02880852|Primary|Terminal Phase Rate Constant (Lambda z) of Belimumab|Blood samples were collected at the indicated time points to calculate lambda z of belimumab.|Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose|PK Parameter Population.|||1/day||Geometric Coefficient of Variation|Geometric Mean
2548350|NCT02880852|Primary|Terminal Phase Half-life (t1/2) of Belimumab|Blood samples were collected at the indicated time points to calculate t1/2 of belimumab.|Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose|PK Parameter Population|||Days||Geometric Coefficient of Variation|Geometric Mean
2548351|NCT02880852|Primary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0 to t]) and Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0 to Inf]) of Belimumab|Blood samples were collected at the indicated timepoints to calculate AUC (0 to t) and AUC (0 to inf) of belimumab.|Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose|PK Parameter Population|||Day*micrograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2552245|NCT02797522|Primary|Pharmacokinetics of ARC-521 Injection: Clearance (CL), Healthy Volunteers||Through 48 hrs post-dose on Day 1|Analysis was not planned or conducted per SAP due to study termination.||||||
2548352|NCT02880852|Primary|Maximum Observed Concentration (Cmax) of Belimumab|Blood samples were collected at the indicated timepoints to calculate Cmax of belimumab.|Day 0 (pre-dose, 5 minutes, 1 hour, 6 hours, 24 hours), and on Days 1, 7, 14, 21, 28, 42, 56, and 84 post-dose|Pharmacokinetic (PK) Parameter Population, which comprised of all those participants who received a dose of belimumab and for whom PK parameters could be calculated.|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2548353|NCT02880761|Other Pre-specified|Mean Value of Urea Clearance Index During 24 Months|As a parameter of hemodialysis adequacy, urea clearance index (Kt/V) will be detected very month. The Kt/V should be larger than 1.2 , which were regarded as being adequate in the hemodialysis session. This parameter will be tested every month and the mean value were be calculated according to the records during 24 months. Those who with Kt/V less than 1.2 for 3 times would be defined as the patient with unfunctional AVF. The values of Kt/V in unfunctional AVF patients would not be used in statistic analysis.|2 years||||Kt/V||Standard Deviation|Mean
2548354|NCT02880761|Secondary|Life Time of AVF|The life time of an available AVF since the AVF is functionable. The life time of an AVF is a period time from the AVF used for hemodialysis treatment at first time to the last time when the AVF can not be used for hemodialysis therapy,, whichever came first, assessed up to 48 months. Since the AVF will be punctured in every hemodialysis session, the function of AVF were detected during every treatment session (3 times per week).|Equal to or larger than 2 years||||month||Standard Deviation|Mean
2548355|NCT02880761|Primary|Number of Participants With Fistula Failure|The AVF can not be used for hemodialysis treatment 3 months after surgery, which it is defined as Primary Failure of AVF. The primary failure of AVF is regarded as the primary outcome of the patients who were followed up. The ratio of primary failure will be compared between two groups.|3 months after surgery||||Participants|||Count of Participants
2548356|NCT02880514|Secondary|Inflammation Score|Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)|Day 30|Inflammation score for 7 sinuses (4 treatment, 3 control) were missing as clinical investigators were unable to view the frontal recess/FSO for 3 treatment and 2 control sinuses, and 1 participant with 1 treatment and 1 control sinuses was lost to follow-up.|||mm|Sinuses|Standard Deviation|Mean
2548357|NCT02880514|Primary|Patency Rate|Patency of the frontal recess/frontal sinus ostia (FSO) was evaluated on a 3-point grading scale from 0 to 2, with 0=Patent, 1=Restenosed/partially occluded, and 2=Occluded. The percentage of sinuses with patency grade 0 and 1 was used to calculate the patency rate.|Day 30|Outcome analyzed using the intent-to-treat population, which consisted of all randomized subjects and sinuses. Patency grade for 10 sinuses (6 treatment, 4 control) were missing as clinical investigators were unable to view the frontal recess/FSO, reducing the number of evaluable subjects to 44 in the treatment group and 46 in the control group.|||sinus sides|sinus sides||Count of Units
2548358|NCT02880475|Primary|Tmax of Naloxone Plasma Concentration|Tmax of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr||Full Range|Median
2548359|NCT02880475|Primary|T1/2 of Naloxone Plasma Concentration|T1/2 of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.|If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf < 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda_z) will not be adopted and will not be included in any statistical analysis.||||||
2548360|NCT02880475|Primary|Lambda_z of Naloxone Plasma Concentration|Lambda_z of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.|If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf < 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda_z) will not be adopted and will not be included in any statistical analysis.||||||
2548361|NCT02880475|Primary|Cmax of Naloxone Plasma Concentration|Cmax of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||pg/mL||Standard Deviation|Mean
2548362|NCT02880475|Primary|AUCinf of Naloxone Plasma Concentration|AUCinf of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.|If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf < 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda_z) will not be adopted and will not be included in any statistical analysis.||||||
2548363|NCT02880475|Primary|AUC_%Extrap of Naloxone Plasma Concentration|AUC_%Extrap of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||(%)||Standard Deviation|Mean
2548364|NCT02880475|Primary|AUC0-t of Naloxone Plasma Concentration|AUC0-t of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr*pg/mL||Standard Deviation|Mean
2548365|NCT02880475|Primary|AUC0-48hr of Naloxone Plasma Concentration|AUC0-48hr of Naloxone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr*pg/mL||Standard Deviation|Mean
2548366|NCT02880475|Primary|Tmax of NLXG Plasma Concentration|Tmax of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr||Full Range|Median
2548367|NCT02880475|Primary|T1/2 of NLXG Plasma Concentration|T1/2 of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr||Standard Deviation|Mean
2548368|NCT02880475|Primary|Lambda_z of NLXG Plasma Concentration|Lambda_z of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||1/hr||Standard Deviation|Mean
2548369|NCT02880475|Primary|Cmax of NLXG Plasma Concentration|Cmax of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||pg/mL||Standard Deviation|Mean
2548370|NCT02880475|Primary|AUCinf of NLXG Plasma Concentration|AUCinf of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr*pg/mL||Standard Deviation|Mean
2548371|NCT02880475|Primary|AUC_%Extrap of NLXG Plasma Concentration|AUC_%Extrap of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||(%)||Standard Deviation|Mean
2548372|NCT02880475|Primary|AUC0-t of NLXG Plasma Concentration|AUC0-t of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr*pg/mL||Standard Deviation|Mean
2548373|NCT02880475|Primary|AUC0-48hr of NLXG Plasma Concentration|AUC0-48hr of NLXG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr*pg/mL||Standard Deviation|Mean
2548374|NCT02880475|Primary|Tmax of NLLG Plasma Concentration|Tmax of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr||Full Range|Median
2548375|NCT02880475|Primary|T1/2 of NLLG Plasma Concentration|T1/2 of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.|If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf < 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda_z) will not be adopted and will not be included in any statistical analysis.|||hr||Standard Deviation|Mean
2548376|NCT02880475|Primary|Lambda_z of NLLG Plasma Concentration|Lambda_z of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.|If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf < 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda_z) will not be adopted and will not be included in any statistical analysis.|||1/hr||Standard Deviation|Mean
2548377|NCT02880475|Primary|Cmax of NLLG Plasma Concentration|Cmax of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||pg/mL||Standard Deviation|Mean
2548378|NCT02880475|Primary|AUCinf of NLLG Plasma Concentration|AUCinf of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.|If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf < 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda_z) will not be adopted and will not be included in any statistical analysis.|||hr*pg/mL||Standard Deviation|Mean
2548379|NCT02880475|Primary|AUC_%Extrap of NLLG Plasma Concentration|AUC_%Extrap of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||(%)||Standard Deviation|Mean
2548380|NCT02880475|Primary|AUC0-t of NLLG Plasma Concentration|AUC0-t of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr*pg/mL||Standard Deviation|Mean
2548381|NCT02880475|Primary|AUC0-48hr of NLLG Plasma Concentration|AUC0-48hr of NLLG plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr*pg/mL||Standard Deviation|Mean
2548382|NCT02880475|Primary|Tmax of 6-B-Naloxol Plasma Concentration|Tmax of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr||Full Range|Median
2548383|NCT02880475|Primary|T1/2 of 6-B-Naloxol Plasma Concentration|T1/2 of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.|If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf < 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda_z) will not be adopted and will not be included in any statistical analysis.|||hr||Standard Deviation|Mean
2548384|NCT02880475|Primary|Lambda_z of 6-B-Naloxol Plasma Concentration|Lambda_z of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.|If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf < 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda_z) will not be adopted and will not be included in any statistical analysis.|||1/hr||Standard Deviation|Mean
2548385|NCT02880475|Primary|Cmax of 6-B-Naloxol Plasma Concentration|Cmax of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||pg/mL||Standard Deviation|Mean
2548386|NCT02880475|Primary|AUCinf of 6-B-Naloxol Plasma Concentration|AUCinf of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.|If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf < 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda_z) will not be adopted and will not be included in any statistical analysis.|||hr*pg/mL||Standard Deviation|Mean
2548387|NCT02880475|Primary|AUC_%Extrap of 6-B-Naloxol Plasma Concentration|AUC_%Extrap of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||(%)||Standard Deviation|Mean
2548388|NCT02880475|Primary|AUC0-t of 6-B-Naloxol Plasma Concentration|AUC0-t of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr*pg/mL||Standard Deviation|Mean
2548389|NCT02880475|Primary|AUC0-48hr of 6-B-Naloxol Plasma Concentration|AUC0-48hr of 6-B-Naloxol plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr*pg/mL||Standard Deviation|Mean
2548390|NCT02880475|Primary|Tmax of Oxymorphone Plasma Concentration|Tmax of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr||Full Range|Median
2548391|NCT02880475|Primary|T1/2 of Oxymorphone Plasma Concentration|T1/2 of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.|If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf < 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda_z) will not be adopted and will not be included in any statistical analysis.||||||
2548392|NCT02880475|Primary|Lambda_z of Oxymorphone Plasma Concentration|Lambda_z of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.|If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf < 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda_z) will not be adopted and will not be included in any statistical analysis.||||||
2548393|NCT02880475|Primary|Cmax of Oxymorphone Plasma Concentration|Cmax of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||ng/mL||Standard Deviation|Mean
2548394|NCT02880475|Primary|AUCinf of Oxymorphone Plasma Concentration|AUCinf of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.|If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf < 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda_z) will not be adopted and will not be included in any statistical analysis.||||||
2548395|NCT02880475|Primary|AUC_%Extrap of Oxymorphone Plasma Concentration|AUC_%Extrap of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||(%)||Standard Deviation|Mean
2548396|NCT02880475|Primary|AUC0-t of Oxymorphone Plasma Concentration|AUC0-t of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr*ng/mL||Standard Deviation|Mean
2548397|NCT02880475|Primary|AUC0-48hr of Oxymorphone Plasma Concentration|AUC0-48hr of Oxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr*ng/mL||Standard Deviation|Mean
2548398|NCT02880475|Primary|Tmax of Oxycodone Plasma Concentration|Tmax of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr||Full Range|Median
2548399|NCT02880475|Primary|T1/2 of Oxycodone Plasma Concentration|T1/2 of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr||Standard Deviation|Mean
2548400|NCT02880475|Primary|Lambda_z of Oxycodone Plasma Concentration|Lambda_z of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||1/hr||Standard Deviation|Mean
2548401|NCT02880475|Primary|Cmax of Oxycodone Plasma Concentration|Cmax of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||ng/mL||Standard Deviation|Mean
2548402|NCT02880475|Primary|AUCinf of Oxycodone Plasma Concentration|AUCinf of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr*ng/mL||Standard Deviation|Mean
2548403|NCT02880475|Primary|AUC_%Extrap of Oxycodone Plasma Concentration|AUC_%Extrap of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||(%)||Standard Deviation|Mean
2548404|NCT02880475|Primary|AUC0-t of Oxycodone Plasma Concentration|AUC0-t of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr*ng/mL||Standard Deviation|Mean
2548405|NCT02880475|Primary|AUC0-48hr of Oxycodone Plasma Concentration|AUC0-48hr of Oxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr*ng/mL||Standard Deviation|Mean
2548406|NCT02880475|Primary|Tmax of Noroxymorphone Plasma Concentration|Tmax of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr||Full Range|Median
2548407|NCT02880475|Primary|T1/2 of Noroxymorphone Plasma Concentration|T1/2 of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr||Standard Deviation|Mean
2548408|NCT02880475|Primary|Lambda_z of Noroxymorphone Plasma Concentration|Lambda_z of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||1/hr||Standard Deviation|Mean
2548409|NCT02880475|Primary|Cmax of Noroxymorphone Plasma Concentration|Cmax of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||ng/mL||Standard Deviation|Mean
2548410|NCT02880475|Primary|AUCinf of Noroxymorphone Plasma Concentration|AUCinf of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr*ng/mL||Standard Deviation|Mean
2548411|NCT02880475|Primary|AUC_%Extrap of Noroxymorphone Plasma Concentration|AUC_%Extrap of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||(%)||Standard Deviation|Mean
2548412|NCT02880475|Primary|AUC0-t of Noroxymorphone Plasma Concentration|AUC0-t of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr*ng/mL||Standard Deviation|Mean
2548413|NCT02880475|Primary|AUC0-48hr of Noroxymorphone Plasma Concentration|AUC0-48hr of Noroxymorphone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr*ng/mL||Standard Deviation|Mean
2548414|NCT02880475|Primary|Tmax of Noroxycodone Plasma Concentration|Tmax of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr||Full Range|Median
2548415|NCT02880475|Primary|T1/2 of Noroxycodone Plasma Concentration|T1/2 of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr||Standard Deviation|Mean
2548416|NCT02880475|Primary|Lambda_z of Noroxycodone Plasma Concentration|Lambda_z of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||1/hr||Standard Deviation|Mean
2548417|NCT02880475|Primary|Cmax of Noroxycodone Plasma Concentration|Cmax of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||ng/mL||Standard Deviation|Mean
2548418|NCT02880475|Primary|AUCinf of Noroxycodone Plasma Concentration|AUCinf of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||hr*ng/mL||Standard Deviation|Mean
2548419|NCT02880475|Primary|AUC_%Extrap of Noroxycodone Plasma Concentration|AUC_%Extrap of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg Will be Analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone, naloxone and metabolites in Chinese patients.||||(%)||Standard Deviation|Mean
2548420|NCT02880475|Primary|AUC0-t of Noroxycodone Plasma Concentration|AUC0-t of Noroxycodone plasma concentration.Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg will be analyzed .(If the extrapolated area of AUC is larger than 20% of AUCinf, i.e. AUC0-t/AUCinf < 0.8, then the elimination-related PK parameters (AUCinf, T1/2, Lambda_z) will not be adopted and will not be included in any statistical analysis. )|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone and metabolites in Chinese patients.|12 subjects in OXN PR tablet 5/2.5 mg group,12 subjects in OXN PR tablet 20/10 mg group.|||hr*ng/mL||Standard Deviation|Mean
2548421|NCT02880475|Primary|AUC0-48hr of Noroxycodone Plasma Concentration.|AUC0-48hr of Noroxycodone plasma concentration. Plasma concentrations of OXN 5/2.5 mg and OXN 20/10mg will be analyzed.|Pre-dose, 0.5h, 1.0h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 14h, 24h, 28h, 32h, 36h, and 48h Post Dose blood sampling to determine the PK of oxycodone and metabolites in Chinese patients.|12 subjects in OXN PR tablet 5/2.5 mg group,12 subjects in OXN PR tablet 20/10 mg group.|||hr*ng/mL||Standard Deviation|Mean
2548422|NCT02880254|Secondary|the Effect of the Kurbo App as Well as the Kurbo App and PHC on 3 Month Change in BMI Zscore Among Morbidly Obese Children and Adolescents Undergoing a Weight Management Program.|BMI zscore will be determined from mathematical calculations derived from subject's height and weight. Z score is the number of standard deviations from the mean. A Z score of 0 is the mean. A change in z score in the positive direction reflects an increase in BMI Z score. A change in z score in the negative direction reflects a decrease in BMI Z score. A decrease in BMI z score indicates a change in BMI that favors weight loss.|3 months||||z score||Standard Deviation|Mean
2548423|NCT02880254|Primary|3 Month Compliance With the Kurbo App as Well as the Kurbo App and PHC by a Group of Morbidly Obese Children and Adolescents in a Weight Management Program.|"A questionnaire will be handed out to each subject every month (see below) where applicable.we will utilize one-sample tests with a one-sided alpha of 0.025. One-sided tests will be used as we are only interested in whether the use of this app results in better outcomes than usual care. Compliance will utilize a binomial probability test to assess compliance against our known compliance of 50%.~Questionnaire is noted here:~Confidential Page 1 of 1 Kurbo Survey [baseline_arm_1][name], DOB [baseline_arm_1][dob] Please complete the survey below. Thank you! Group Allocation __________________________________ Who is completing this survey? Child / Patient Parent / Guardian Over the last month, abou"|3 months|Assuming we find improved compliance and BMI-z scores, we will estimate compliance and BMI-z score differences between Kurbo and Kurbo + PHC. Estimates will be generated using direct observation as well as prediction through modeling.|||percent compliant|||Number
2548424|NCT02880228|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|From time of registration to death due to any cause, assessed up to 3 years|All patients that began protocol treatment are included in this analysis.|||months||95% Confidence Interval|Median
2548425|NCT02880228|Secondary|Proportion of Successful Stem Cell Collection|The proportion of successful stem cell collection following initial therapy with the combination of pembrolizumab, lenalidomide and dexamethasone in patients with newly diagnosed MM will be estimated by the number of patients with a successful stem cell collection divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true successful proportion will be calculated.|Up to 112 days|Only patients that completed 4 cycles of treatment were eligible for this endpoint.|||proportion of participants||95% Confidence Interval|Number
2551303|NCT02819804|Secondary|Serum Level of Dasatinib|The serum level of dasatinib will be measured at 24 hours after the start of cycle 1 and on days 8, 15, and 22 prior to treatment during cycle 1.|24 hours after the start of cycle 1 and days 8, 15, and 22 prior to treatment during cycle 1|||||||
2548426|NCT02880228|Secondary|Partial Response (PR)|"The PR response after 4 cycles of induction treatment with pembrolizumab added to lenalidomide and dexamethasone will be estimated by the number of patients who achieve a PR, VGPR, CR, or sCR after 4 cycles divided by the total number of evaluable patients. A PR is defined by the following criteria: >~If present at baseline, ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein or to <200 mg/24hrs >~If the only measurable disease is FLC, a ≥50% reduction in the difference between involved and involved FLC levels >~If the only measurable disease is BM, a ≥50% reduction in BM PC's (provided the baseline PC's was ≥30%) >~If present at baseline, ≥50% reduction in the size of soft tissue plasmacytomas >~Exact binomial 95% confidence intervals for the true success rate will be calculated."|Up to 112 days|Only patients that completed 4 cycles of treatment were included in this endpoint.|||proportion of participants||95% Confidence Interval|Number
2548427|NCT02880228|Secondary|Progression-free Survival|Progression-free survival is defined as the time from registration to the earliest date of documentation of disease progression or death due to any cause. Patients who receive subsequent treatment for myeloma before disease progression will be censored on the date of their last disease assessment prior to initiation of the subsequent treatment. Transplant will not be considered subsequent treatment. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.|From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 3 years|All patients that began protocol treatment were included in this analysis.|||months||95% Confidence Interval|Median
2548428|NCT02880228|Primary|Proportion of Complete Response Plus Very Good Partial Response (VGPR)|"The International Myeloma Working Group response criteria was used to assess response to therapy. The proportion of VGPR response at any time during treatment with pembrolizumab added to lenalidomide and dexamethasone will be estimated by the number of patients achieving a VGPR, CR, or sCR at any time divided by the total number of evaluable patients. A very good partial response (VGPR) is defined as as a demonstration of:~Serum and urine M-component detectable by immunofixation but not on electrophoresis c or~greater than 90% reduction in serum m-component and urine m-component <100 mg/24 h~If the only measurable disease is FLC, a ≥90% reduction in the difference between involved and involved FLC levels~The proportion of successes will be estimated by the number of patients demonstrating a VGPR or better divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner."|Up to 112 days||||proportion of participants||95% Confidence Interval|Number
2548429|NCT02880189|Secondary|Diagnosis of NASH and Early Fibrosis by Endoscopic Ultrasound (EUS) Guided Liver Core Biopsies|Total number of subjects correctly diagnosed with NASH and Early Fibrosis by EUS guided core liver biopsies|Baseline to 6 months post-procedure||||Participants|||Count of Participants
2548430|NCT02880189|Primary|Weight Loss Achieved With Intragastric Balloon (IGB)|Total number of subjects with two points or greater improvement on objective Non-alcoholic Steatohepatitis (NASH) histopathological parameters|Baseline to 6 months post-procedure||||Participants|||Count of Participants
2548431|NCT02880137|Primary|Number of Subjects With a Perfusion Defect|A perfusion defect will first be identified using clinically indicated invasive coronary angiography (ICA). The presence of a perfusion defect will then be identified using non-invasive real time myocardial perfusion echocardiography (RTMPE).|baseline||||Participants|||Count of Participants
2548432|NCT02879747|Other Pre-specified|Changes in Height|Changes in height standard deviation scores (SDS) (calculated as height in cm at start converted to SDS and height in cm after two years in the trial converted to SDS)|start of study to two years after start in the trial||||standard deviation scores||Standard Deviation|Mean
2548433|NCT02879747|Secondary|Height SDS at Start of Puberty|Height at start of puberty measured as cm and expressed as standard deviation score (SDS) to adjust for age and gender|1-7 years in the trial|All 98 Children were measured at start of puberty|||standard deviation scores||Standard Deviation|Mean
2548434|NCT02879747|Secondary|IGF-I|"Delta Insulin-like growth factor-I (24 months after start compared to start of study) expressed as ng/ml and converted to standard deviation scores (SDS) to adjust for gender and age.~A standard deviation score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A mean value within +-0.5 SDS and a range within +-1.0 SDS is a favorable outcome."|start of study to two years after start in the trial|Drop outs due to puberty or adverse events|||standard deviation scores||Standard Deviation|Mean
2548435|NCT02879747|Primary|The Proportion of Children Maintaining Normal Growth Velocity|The proportion of children in the intervention 1 group (=reduced dose) that maintained an individual ΔheightSDS within ±0.3 during the first year of the Maintenance trial, compared to the proportion of children in the intervention 2 group (non-reduced dose)|twelve months||||Participants|||Count of Participants
2548436|NCT02879032|Primary|Exercise Treadmill Scores|Using angiographic evidence of Coronary Artery Disease (CAD) as the reference, area under the curve (AUC) of Receiver operating characteristic (ROC) plots were determined for each treadmill score. The AUC for each treadmill score was compared the AUCs of the other treadmill scores. Maximum value for AUC is 1 where value towards 1 means more accurate treadmill score. Based on the study by Shaw et al. (1998), DTS <+5 is considered abnormal. High risk when DTS is <-10 and low risk when DTS is >+5. The simplified score had a rang from 6 to 95, with <40 designated as low probability, between 40-60 was intermediate probability, and >60 was high probability for CAD. STS calculation for male and female subjects was done by formula provided by Raxwal et al. (2002) and Morise et al. (2002), respectively. Arbitrarity we have assumed CCS will predict significant CAD with high probability if the value is >100 and low probability if it is <80 (Lauer et al. 2007).|12 months||||Probability by AUC||95% Confidence Interval|Number
2548437|NCT02878590|Primary|Change in Apnea-Hypopnea Index (AHI)|Obstructive Sleep Apnea (OSA) severity is divided into three categories based on the Apnea-Hypopnea Index (AHI) as follows: Mild (AHI of 5 to 15), Moderate (AHI of 15 to 30), and Severe (AHI > 30). AHI is calculated by dividing the number of events (i.e. Apneas and hypopneas) by the number of hours of sleep. The primary outcome for the study was change in AHI, defined as the difference in AHI between the diagnostic PSG study (baseline with no device) and the final PSG study with the Bongo device for the subjects that completed the entire study.|At Diagnostic Baseline PSG and at Final Treatment PSG with the device|All subjects that completed the entire study.|||events per hour||Standard Deviation|Mean
2551304|NCT02819804|Secondary|Rate of Molecular Remission|Determine the rate of molecular remission after three cycles of nivolumab and dasatinib.|At 84 days (3 cycles)|||||||
2548438|NCT02878486|Post-Hoc|Change in HOMA-IR (Homeostatic Model Assessment of Insulin Resistance)|HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) is calculated as fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. The average HOMA-IR at week 12 minus the average HOMA-IR at baseline. A lower score means a person is more sensitive to insulin, whereas a higher score indicates greater resistance to insulin. The HOMA-IR is a tool for calculating degree of insulin resistance. Given that this is a product of insulin and glucose values divided by a constant, there is no maximum score for this measure. The minimum score would be zero as neither insulin or glucose would drop below zero.|Change from baseline to week 12|Only three participants had data available for the mixed meal tolerance test|||units on a scale||Standard Deviation|Mean
2548439|NCT02878486|Secondary|Change in Insulin Levels Area Under the Curve Based on a Mixed Meal Tolerance Test|"The average area under the curve at week 12 minus the average area under the curve at baseline. Blood was collected at baseline (pre-mixed meal). Post-mixed meal it was collected at 15, 30, 45, 60, 90, 120 minutes. The Area Under the Curve (AUC) was computed using the trapezoidal rule as we have previously described (Burns et. al. 2012, Morris et al 2014). This results in a single AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome measure (glucose, insulin, etc).~The Area Under the Curve (AUC) for each individual is calculated as a single unitless value that results from calculating the definite integral under a timecourse curve. This method has been widely used and cited in metabolic studies for more than two decades https://doi.org/10.2337/diacare.17.2.152. This results in a single unitless AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome response measure (glucose, insulin, etc)."|Change from Baseline to Week 12|Only three participants had data available for the mixed meal tolerance test|||unitless||Standard Deviation|Mean
2548440|NCT02878486|Secondary|Change in Glucose Levels Area Under the Curve in Response to Mixed Meal Tolerance Test|"The average area under the curve at week 12 minus the average area under the curve at baseline. Blood was collected at baseline (pre-mixed meal). Post-mixed meal it was collected at 15, 30, 45, 60, 90, 120 minutes. The Area Under the Curve (AUC) was computed using the trapezoidal rule as we have previously described (Burns et. al. 2012, Morris et al 2014). This results in a single AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome measure (glucose, insulin, etc).~The Area Under the Curve (AUC) for each individual is calculated as a single unitless value that results from calculating the definite integral under a timecourse curve. This method has been widely used and cited in metabolic studies for more than two decades https://doi.org/10.2337/diacare.17.2.152. This results in a single unitless AUC pre-intervention value, and a single AUC post-intervention value for each metabolic outcome response measure (glucose, insulin, etc)."|Change from Baseline to Week 12|Only three participants had data available for the mixed meal tolerance test|||unitless||Standard Deviation|Mean
2548441|NCT02878486|Secondary|Number of Sitting Bouts Greater Than 30 Min|Change in the number of sitting bouts greater than 30 min measured using the ActivPAL monitor|Week 12||||sitting bouts||Standard Deviation|Mean
2548442|NCT02878486|Secondary|Change in Average Daily Sitting Time|Average daily sitting time (minus sleep) at 12 weeks minus average daily sitting time (minus sleep) at baseline measured using the ActivPAL monitor|Change from Baseline to Week 12||||minutes per day||Standard Deviation|Mean
2548443|NCT02878486|Primary|Change in Average Daily Sitting Time|Average daily sitting time (minus sleep) at 6 weeks minus average daily sitting time (minus sleep) at baseline measured using the activPAL monitor|Change from Baseline to Week 6||||minutes per day||Standard Deviation|Mean
2548444|NCT02878330|Secondary|Number of Participants With Positive Anti-drug Antibodies to MEDI8897|The number of participants with positive serum antibodies to MEDI8897 are reported.|Days 91, 151, and 361|As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.|||Participants|||Count of Participants
2548445|NCT02878330|Secondary|Elimination Half-life (t1/2) of MEDI8897|Terminal elimination half-life (t½) is the time required for half of the drug to be eliminated from the serum.|Day 91 through Day 361|As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received. Participants with sufficient additional pharmacokinetics (PK) samples from unscheduled visits were analysed for this outcome measure.|||Days||Standard Deviation|Mean
2548446|NCT02878330|Secondary|Serum Concentration of MEDI8897||Days 91, 151, and 361|As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.|||mcg/mL||Standard Deviation|Mean
2548447|NCT02878330|Secondary|Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs)|An AESI was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor. An AESI may be serious or non-serious. A NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature. It is observed after receiving study drug and is assessed by investigator as medically significant.|From Day 1 through Day 361|As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.|||Participants|||Count of Participants
2548448|NCT02878330|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.|From Day 1 through Day 361|As-treated population included all randomized participants who received any study drug and analyzed according to the study drug they actually received.|||Participants|||Count of Participants
2548509|NCT02875977|Secondary|PFPT Discharge|The number of patients who discharged from PFPT is compared between those assigned to enhanced counseling versus standard counseling|3 months|This analysis comprises only the participants who were randomized and had follow-up PFPT completion information available|||Participants|||Count of Participants
2548449|NCT02878330|Secondary|Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI)|A RSV hospitalization is defined as either 1) a respiratory hospitalization with a positive RSV test within 2 days of hospitalization (primary) or 2) new onset of respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial).|From Day 1 through Day 151|The ITT population included all participants who were randomized in the study and analyzed according to their randomized treatment group.|||Participants|||Count of Participants
2548450|NCT02878330|Primary|Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI)|The determination of medically attended RSV LRTI is based on objective clinical LRTI criteria and RSV test results obtained from analyzing the respiratory secretions using a validated RSV real time reverse transcriptase-polymerase chain reaction (RT-PCR) assay for the detection of RSV A or RSV B subtypes. Criteria for LRTI included documented physical exam findings of rhonchi, rales, crackles, or wheeze and any of the following: increased respiratory rate at rest (for age less than (<) 2 months: greater than or equal to (>=) 60 breaths/min; 2-6 months: >= 50 breaths/min; and for > 6 months - 2 years, >= 40 breaths/min), or hypoxemia (in room air - oxygen saturation < 95% at altitudes less than or equal to (<=) 1800 meters or < 92% at altitudes > 1800 meters), or clinical signs of severe respiratory disease or dehydration secondary to inadequate oral intake due to respiratory distress (need for intravenous fluid).|From Day 1 through Day 151|The ITT population included all participants who were randomized in the study and analyzed according to their randomized treatment group.|||Participants|||Count of Participants
2548451|NCT02878213|Primary|1-month Patient Analysis|ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy|30 days|All patients were analyzed|||Participants|||Count of Participants
2548452|NCT02878213|Primary|ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy|"ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy. All patients underwent PVI at index procedure. The physicians were blinded to the D700 (KODEX-EPD) ETA function pairwise real-time lesion assessment readings.~All patients were restudied at 1-mont, and ETA reading, which is the number of gaps as predicted by the system, were compared to the actual gaps as validated in the second procedure after one month."|30 days|Analyzed ablation pairs in all participants|||participants|||Number
2548453|NCT02877927|Secondary|Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population|At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; infection was sufficiently resolved such that further antibacterial therapy was not needed. Participants may have had some residual changes related to infection requiring ancillary treatment. Clinical Failure was defined as meeting any of the following criteria: infection required additional treatment with alternative antibacterial therapy; participant received antibacterial therapy between the EOT Visit and the PTE Visit that may have been effective for the infection under study for a different infection from the one under study; unplanned major surgical intervention for the infection under study between the EOT and PTE Visits; participant died before evaluation; other specified reason.|Screening; 7 to 14 days after the last day of therapy|CE-PTE Population: all participants in the mITT Population meeting additional pre-defined criteria|||Participants|||Count of Participants
2548454|NCT02877927|Secondary|Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit|At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; infection was sufficiently resolved such that further antibacterial therapy was not needed. Participants may have had some residual changes related to infection requiring ancillary treatment. Clinical Failure was defined as meeting any of the following criteria: infection required additional treatment with alternative antibacterial therapy; participant received antibacterial therapy between the End-of-Treatment (EOT) Visit and the PTE Visit that may have been effective for the infection under study for a different infection from the one under study; unplanned major surgical intervention for the infection under study between the EOT and PTE Visits; participant died before evaluation; other specified reason. Indeterminate The clinical response to test article could not be adequately inferred.|Screening; 7 to 14 days after the last day of therapy|mITT Population|||Participants|||Count of Participants
2548455|NCT02877927|Primary|Number of Participants With Early Clinical Response|Early clinical response is defined as clinical success, which is categorized as survival with at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to Screening measurements, without receiving any rescue antibacterial therapy. An indeterminate classification is used for a response that could not be adequately inferred because the participant was not assessed because they withdrew consent, were lost to follow-up, or other specified reason.|Screening; 48 to 72 hours after the first dose of test article|Modified Intent-to-Treat (mITT) Population: all randomized participants without a baseline sole Gram-negative ABSSSI pathogen|||Participants|||Count of Participants
2548456|NCT02877732|Secondary|Compare DEM Test and EYE-SYNC Score|The Developmental Eye Movement (DEM) assessment and EYE-SYNC score will be compared.|Immediate post impact, 2 days, 7 days and 14 days post impact.|Study was cancelled by the funder prior to collection of any outcome data; only screening procedures were performed.||||||
2548457|NCT02877732|Secondary|Compare ANAM-SRT Test and EYE-SYNC Score|The Automated Neuropsychological Assessment Metrics-Simple Reaction Time (ANAM-SRT) evaluation and EYE-SYNC score will be compared.|Immediate post impact, 2 days, 7 days and 14 days post impact.|Study was cancelled by the funder prior to collection of any outcome data; only screening procedures were performed.||||||
2548458|NCT02877732|Secondary|Compare Sport Concussion Assessment Tool (SCAT-3) Test and EYE-SYNC Score|The SCAT-3 result and EYE-SYNC score will be compared.|Immediate post impact, 2 days, 7 days and 14 days post impact.|Study was cancelled by the funder prior to collection of any outcome data; only screening procedures were performed.||||||
2548459|NCT02877732|Primary|Integrity of EYE-SYNC Data|The reliability will be analyzed based on the score obtained from EYE-SYNC.|Immediate post impact, 2 days, 7 days and 14 days post impact.|Study was cancelled by the funder prior to collection of any outcome data; only screening procedures were performed.||||||
2551305|NCT02819804|Secondary|Rate of Complete Hematologic Remission (CR)|Determine the rate of complete hematologic remission (CR) after three cycles of nivolumab and dasatinib|At 84 days (3 cycles)|||||||
2548461|NCT02877732|Primary|Changes in the Measurement of EYE-SYNC Data Immediately After Concussive Event, 2 Days, 7 Days and 14 Days Post Concussive Event.|The EYE-SYNC test will be performed immediately after an impact, 2 days, 7 days and 14 days post impact. The movement of eye will be tracked using EYE-SYNC. The data will be recorded in a surface tablet connected to EYE-SYNC.|Immediate post impact, 2 days, 7 days and 14 days post impact.|Study was cancelled by the funder prior to collection of any outcome data; only screening procedures were performed.||||||
2548462|NCT02877095|Primary|Overall Safety of a Strategy Based on Subcutaneous Delivery of Furosemide in Inpatients and Outpatients as Measured by Number of Adverse Events|The analysis of data from the Pilot Phase will be primarily descriptive in nature and there will be no formal hypothesis testing. Number of patients with events will be reported.|14 days||||participants|||Number
2548463|NCT02877082|Secondary|Overall Survival|Will be analyzed with Kaplan Meier method and Logrank test.|At 1 year post-transplant|Data were not collected because trial closed early.||||||
2548464|NCT02877082|Secondary|Incidence of Chronic GVHD|Will be summarized as percentage and 95% confidence level will be also constructed.|Up to 2 years post-transplant|Data were not collected because trial closed early.||||||
2548465|NCT02877082|Secondary|Cumulative Incidence of Grade III-IV aGVHD|Will be summarized as percentage and 95% confidence level will be also constructed.|Up to 2 years post-transplant|Data were not collected because trial closed early.||||||
2548466|NCT02877082|Primary|Number of Patients Alive and Free of Severe Acute GVHD Following HLA Matched Related or Unrelated Donor Hematopoietic Peripheral Blood Transplant|Will use patient counts for the number of patients alive and free of severe acute graft versus host disease (GVHD) following human leukocyte antigen (HLA) matched related or unrelated donor hematopoietic peripheral blood transplant.|At 6 months post-transplant||||Participants|||Count of Participants
2548467|NCT02877082|Primary|Total Number of Serious Adverse Events and Adverse Events Related to This Immunosuppressive Regimen|"An adverse event (AE) is defined as any untoward medical experience or change of an existing condition that occurs during or after treatment. All AEs occurring during this study, whether observed by the physician, nurse, or reported by the patient, will be graded per NCI CTCAE version 4.0 and recorded on protocol-specific case report forms. A serious adverse event (SAE) is defined as any expected or unexpected adverse event (AE, generally equivalent to CTCAE grades 3, 4 or 5) that results in any of the following outcomes:~Death~Life-threatening event~In-patient hospitalization (not required as part of the treatment) or prolongation of existing hospitalization~Persistent or significant disability/incapacity~Congenital anomaly/birth defect~Cancer~Overdose"|Up to 6 months post-transplant||||events|||Number
2548468|NCT02877004|Primary|Change in Waist Circumference|Comparison of waist circumference change from baseline between arms|baseline and 4 weeks||||cm||Standard Deviation|Mean
2548469|NCT02877004|Primary|Change in Weight|Comparison of weight change from baseline between arms|baseline and 4 weeks||||Kg||Standard Deviation|Mean
2548470|NCT02876926|Primary|Number of Participants Who Reported Having Actually Received a Prescription for Pre-exposure Prophylaxis|Count of the number of participants who reported actually having received a prescription for pre-exposure prophylaxis after having been referred by a medical professional.|Up to 28 weeks||||Participants|||Count of Participants
2548471|NCT02876926|Primary|Number of Participants Who Reported Having Been Referred for Pre-exposure Prophylaxis|Count of the number of participants who reported receiving a referral for pre-exposure prophylaxis from a counselor or medical professional.|Up to 28 weeks||||Participants|||Count of Participants
2548472|NCT02876926|Primary|Number of Participants Who Received HIV Testing|Count of the number of participants who reported receiving HIV testing.|Up to 28 weeks||||Participants|||Count of Participants
2548473|NCT02876900|Secondary|Evaluate Efficacy and Safety of Asenapine Maleate Patches Compared With Placebo Patches in Subjects Diagnosed With Schizophrenia as Measured Using the Clinical Global Impression - Severity of Illness Scale: Change From Baseline to Week 6.|"To evaluate efficacy and safety of HP-3070 compared with placebo for the treatment of schizophrenia as evaluated by the Clinical Global Impression - Severity of Illness Scale.~The severity of illness for each participant was rated using the CGI-S. The rater or Investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?. Response choices included: 0 = not assessed; 1 = normal, not at all ill, 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|6 weeks|Results are from the full analysis set (FAS) which includes all randomized participants who had at least 1 patch of double-blind study medication applied and who have a baseline PANSS total score and at least 1 post baseline assessment of the primary efficacy measure (PANSS total score) and completed the study.|||score on a scale||Standard Deviation|Least Squares Mean
2548474|NCT02876900|Primary|Evaluate Efficacy and Safety of Asenapine Maleate Patches Compared With Placebo Patches in Subjects Diagnosed With Schizophrenia as Measured Using the Syndrome Scale (PANSS) Total Score: Change From Baseline to Week 6.|"To evaluate efficacy and safety of HP-3070 compared with placebo for the treatment of schizophrenia as evaluated by Positive and Negative Syndrome Scale (PANSS) total score.~The PANSS total score is the sum of all 30 items (7 positive items, 7 negative items, and 16 general psychopathology items). For each item, severity was rated on an anchored 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. If one or more items are missing at a given assessment, the total score is set to missing. Total score ranges from 30 to 210. Score indicates severity of the disease, i.e. low score = low severity."|6 weeks|Results are from the full analysis set (FAS) which includes all randomized participants who had at least 1 patch of double-blind study medication applied and who have a baseline PANSS total score and at least 1 post baseline assessment of the primary efficacy measure (PANSS total score) and completed the study.|||score on a scale||Standard Error|Least Squares Mean
2548485|NCT02876601|Secondary|Tumor Necrosis Factor (TNF)-Alpha|"Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject.~The respective arbitrary unit therefore is fold*h."|This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements.|"The placebo period (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison"|||fold*h||Inter-Quartile Range|Median
2548475|NCT02876757|Secondary|Depression (Based on Administrative Data Elements From Hospital Discharge Abstract Database, and Ontario Regional Mental Health Database and Ontario Health Insurance Plan)|"Any CIHI-DAD/SDS ICD 10 code, OR~Any OMRHS code Axis1_dsm4code1-19 or Axis2_dsm4code 1-7 OR~Look for any OHIP record billed by Mainspecialty = PSYCHIATRY with a diagnosis of depression OHIP dxcode 311, OR~≥2 GP visits within 2 years AND both with OHIP dxcode 311~i. OHIP dxcode: 311 ii. ICD 10: F32.0, F32.1, F32.2, F32.3, F32.8, F32.9, F33.0, F33.1, F33.2, F33.3, F33.4, F33.8, F34.1 iii. Psychiatry visits defined as any of these OHIP fee codes: A195, A895, A190, A795, A695, A395, A196, A193, A194, A191, A192 iv. OMHRS: 29620-29626, 29630-29636, 31100 (major depressive disorder)"|Through study completition, an average of 18 months.|This population is restricted to those who had no history of depression, thus it is a subgroup of the total study population.|||Participants|||Count of Participants
2548476|NCT02876757|Secondary|Suicide Attempt (Based on Administrative Data Elements From National Ambulatory Care Reporting System, and Ontario Regional Mental Health Database)|"NACRS: presentation to the emergency room: ICD 10 codes X60-X84 (intentional self harm).~OMHRS: admission with suicide ideation.~i. Self injury attempts: D1A or selfinjury_attempt=3, 4, 5, or 6 ii. Self injury intent: D1B or selfinjury_intent=1 iii. Self injury considered: D1C or selfinjury_cons=3, 4, 5 or 6 iv. Self injury plan: D1DB or suicide_plan=1"|Through study completition, an average of 18 months.||||Participants|||Count of Participants
2548477|NCT02876757|Primary|Suicide (Based on Administrative Data Elements From Ontario Registrar General Death Database, National Ambulatory Care Reporting System, Hospital Discharge Abstracts, and Ontario Regional Mental Health Database)|"Ontario Registrar General Death database. Use the COD_primary variable (used from 2003 onwards) to define suicide, based on an ICD10 code of X60-X84.~NACRS: X60-84 (dx10code1-dx10code10) AND dead on arrival or death after arrival (visdisp2002 = 10 or 11). Consider admission date the date of the event.~OMHRS: Discharge reason (dischreason (X90) = 2). Died from suicide. Consider admission date the date of the event.~CIHI-DAD (Consider admission date the date of the event):~i. suicide=1, or ii. dx10code1-25= ICD10 X60-84 AND dischdisp=07."|Through study completition, an average of 18 months.||||Participants|||Count of Participants
2548478|NCT02876601|Secondary|Maximum Lysis in Thromboelastometry|"Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject.~The respective arbitrary unit therefore is fold*h."|This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h and AUC was calculated based on these measurements.|"The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo).~The placebo period (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison."|||fold*h||Inter-Quartile Range|Median
2548479|NCT02876601|Secondary|Clotting Time in Thromboelastometry|"In this analysis, first of all a ratio of the measurement time point to the baseline was calculated. Thereafter deltas (baeline-ratio) were calculated. With the results an AUC was calculated.~The respective arbitrary unit therefore is fold*h."|This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements.|"The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo).~The placebo period (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison."|||fold*h||Inter-Quartile Range|Median
2548480|NCT02876601|Secondary|Von Willebrand Factor Antigen|"Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The quantification of von Willebrand Factor is based on reference values and results are in % of normal.~The respective arbitrary unit therefore is %*h."|This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements.|"The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo).~The placebo period (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison."|||%*h||Inter-Quartile Range|Median
2548481|NCT02876601|Secondary|Plasminogen Activator Inhibitor 1|"Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject.~The respective arbitrary unit therefore is fold*h."|This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements.|"The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo).~The placebo period (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison"|||fold*h||Inter-Quartile Range|Median
2548482|NCT02876601|Secondary|E-Selectin|"Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject.~The respective arbitrary unit therefore is fold*h."|This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements.|"The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo).~The placebo period (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison"|||fold*h||Inter-Quartile Range|Median
2548483|NCT02876601|Secondary|Interleukin-6|Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h.|This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements.|"The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo).~The placebo period (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison"|||fold*h||Inter-Quartile Range|Median
2548484|NCT02876601|Secondary|Tissue-type Plasminogen Activator|"Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject.~The respective arbitrary unit therefore is fold*h."|This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements.|"The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo).~The placebo period (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison"|||fold*h||Inter-Quartile Range|Median
2548486|NCT02876601|Secondary|Plasmin-Antiplasmin Complexes|"Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h.~The placebo period (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison"|This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, and 6h and AUC was calculated based on these measurements.|"The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo).~The placebo period (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison"|||fold*h||Inter-Quartile Range|Median
2548487|NCT02876601|Secondary|Thrombin-Antithrombin Complexes|"Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h.~The placebo period (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison"|This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements.|"The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo).~The placebo period (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison"|||fold*h||Inter-Quartile Range|Median
2548488|NCT02876601|Primary|Prothrombin Fragments f1+2|"Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h.~The placebo period (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison"|The parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h.|"The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo).~The placebo period (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison"|||fold-change*h||Inter-Quartile Range|Median
2548489|NCT02876575|Secondary|Time to Normal Activity Following the Use of the BiZact™ Device in Adult (≥22 Years of Age in United States and ≥18 Years of Age in Europe) Tonsillectomy Procedures|"Ability to return to Normal, subject's baseline, activity. EORTC Quality of Life Questionnaire (EORTC QLQ -H&N35) will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. The module consists of 35 questions assessing symptoms and side effects of treatment, social function, and body image/sexuality. The head and neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact, and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems. This score will be assessed qualitatively by asking if they have experienced symptoms or problems using the below subgroups:~Not at all: 1~A little: 2~Quite a bit: 3~Very much: 4"|Post-operative Day 28||||days||Standard Deviation|Mean
2548490|NCT02876575|Secondary|Time to Normal Diet Following the Use of the BiZact™ Device in Adult (≥22 Years of Age in United States and ≥18 Years of Age in Europe) Tonsillectomy Procedures|"Ability to return to Normal, subject's baseline, diet. EORTC Quality of Life Questionnaire (EORTC QLQ -H&N35) will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. The module consists of 35 questions assessing symptoms and side effects of treatment, social function, and body image/sexuality. The head and neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact, and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems. This score will be assessed qualitatively by asking if they have experienced symptoms or problems using the below subgroups:~Not at all: 1~A little: 2~Quite a bit: 3~Very much: 4"|Post-operative Day 28||||days||Standard Deviation|Mean
2548491|NCT02876575|Primary|Pain Assessment Using a Visual Analog Scale (VAS)|"The severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups:~No Pain: VAS= 0~Mild Pain: VAS > 0 and < 4~Moderate: VAS ≥ 4 and < 7~Severe: VAS ≥ 7"|Post-operative Day 14|46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 14 as directed by the protocol.|||units on a scale||Standard Deviation|Mean
2548492|NCT02876575|Primary|Pain Assessment Using a Visual Analog Scale (VAS)|"The severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups:~No Pain: VAS= 0~Mild Pain: VAS > 0 and < 4~Moderate: VAS ≥ 4 and < 7~Severe: VAS ≥ 7"|Post-operative Day 10|46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 10 as directed by the protocol.|||units on a scale||Standard Deviation|Mean
2548493|NCT02876575|Primary|Pain Assessment Using a Visual Analog Scale (VAS)|"The severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups:~No Pain: VAS= 0~Mild Pain: VAS > 0 and < 4~Moderate: VAS ≥ 4 and < 7~Severe: VAS ≥ 7"|Post-operative Day 7|46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 7 as directed by the protocol.|||units on a scale||Standard Deviation|Mean
2548494|NCT02876575|Primary|Pain Assessment Using a Visual Analog Scale (VAS)|"The severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups:~No Pain: VAS= 0~Mild Pain: VAS > 0 and < 4~Moderate: VAS ≥ 4 and < 7~Severe: VAS ≥ 7"|Post-operative Day 6|46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 6 as directed by the protocol.|||units on a scale||Standard Deviation|Mean
2548495|NCT02876575|Primary|Pain Assessment Using a Visual Analog Scale (VAS)|"The severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups:~No Pain: VAS= 0~Mild Pain: VAS > 0 and < 4~Moderate: VAS ≥ 4 and < 7~Severe: VAS ≥ 7"|Post-operative Day 5|46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 5 as directed by the protocol.|||units on a scale||Standard Deviation|Mean
2548496|NCT02876575|Primary|Pain Assessment Using a Visual Analog Scale (VAS)|"The severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups:~No Pain: VAS= 0~Mild Pain: VAS > 0 and < 4~Moderate: VAS ≥ 4 and < 7~Severe: VAS ≥ 7"|Post-operative Day 4|46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 4 as directed by the protocol.|||units on a scale||Standard Deviation|Mean
2548497|NCT02876575|Primary|Pain Assessment Using a Visual Analog Scale (VAS)|"The severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups:~No Pain: VAS= 0~Mild Pain: VAS > 0 and < 4~Moderate: VAS ≥ 4 and < 7~Severe: VAS ≥ 7"|Post-operative Day 3|45 out of 48 subjects completed the post-operative assessment as directed by the protocol, 3 subjects did not completed the assessment on day 3 as directed by the protocol.|||units on a scale||Standard Deviation|Mean
2548498|NCT02876575|Primary|Pain Assessment Using a Visual Analog Scale (VAS)|"The severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups:~No Pain: VAS= 0~Mild Pain: VAS > 0 and < 4~Moderate: VAS ≥ 4 and < 7~Severe: VAS ≥ 7"|Post-operative Day 2|46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 2 as directed by the protocol.|||units on a scale||Standard Deviation|Mean
2548499|NCT02876575|Primary|Pain Assessment Using a Visual Analog Scale (VAS)|"The severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures will be analyzed at each post-operative assessment: at days 1 through 7, 10 and 14. This pain score will be assessed quantitatively using the VAS scale and qualitatively using the below subgroups:~No Pain: VAS= 0~Mild Pain: VAS > 0 and < 4~Moderate: VAS ≥ 4 and < 7~Severe: VAS ≥ 7"|Post-operative Day 1|46 out of 48 subjects completed the post-operative assessment as directed by the protocol, 2 subjects did not completed the assessment on day 1 as directed by the protocol.|||units on a scale||Standard Deviation|Mean
2548500|NCT02876159|Secondary|Change in Mean Levels of Antigen-specific Cluster of Differentiation 8 (CD8) + T Cells|CD8+T cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.|Up to 29 Days|CD8+T cell assays were not collected since the split virus influenza vaccine was not likely to induce any detectable CD8+ T cell responses.||||||
2548501|NCT02876159|Secondary|Change in Mean Levels of Antigen-specific IL-2 Producing CD4+ T Cells|Antigen-specific Interleukin 2 (IL-2) producing cluster of differentiation 4 (CD4)+ T cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.|Up to 29 Days||||cells/mm^3||Standard Deviation|Mean
2548502|NCT02876159|Secondary|Change in Mean Levels of Memory B Cells From Baseline (Day 1) to Day 29|Memory B cells will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.|Baseline (Day 1) and Day 29|only 9 participant samples were analyzed as 1 sample could not be analyzed|||cells/mm^3||Standard Deviation|Mean
2548503|NCT02876159|Secondary|Change in Mean Levels of Plasmablasts|Plasmablasts will be collected via blood draw. Change is defined as the difference in mean levels from baseline to Day 29.|Up to 29 Days||||cells/mm^3||Standard Deviation|Mean
2548504|NCT02876159|Primary|Change in Mean Level of Circulating Follicular Helper T (TFH) Cells|TFH cells will be collected via blood draw. Change is defined as the difference in the mean levels of cells from baseline, day 8, and day 15.|Up to 15 Days||||cells/mm^3||Standard Deviation|Mean
2548505|NCT02876159|Primary|Change in Geometric Mean Serum Hemagglutination Inhibition (HAI) Antibody Titer|Geometric mean serum HAI antibody titers serum HAI titer will be collected via blood draw. Titer for serum HAI antibodies will be calculated using the geometric mean. Change is defined as the difference in means from Day 1 to Day 29.|Baseline (Day 1), Day 29||||HAI antibody Titers||Standard Deviation|Mean
2548506|NCT02876055|Primary|Comparing Pain Intensity and Opioid-Related Adverse Effects Using Overall Benefit of Analgesia Score (OBAS).|The OBAS score was calculated using the sum of the scores from six questions. OBAS ranges from 0 (best) to 28 (worst), where a low score indicates a high benefit to the subjects.|Post-Operative Day 1||||score on a scale||Inter-Quartile Range|Median
2548507|NCT02875977|Secondary|Change in Urogenital Distress From Baseline to 3 Months|Patients complete the Urinary Distress Inventory 6 (UDI-6) prior to beginning PFPT therapy and following PFPT therapy. The change in UDI-6 from baseline to 3 months following therapy is compared between those assigned to enhanced counseling versus standard counseling. The UDI-6 is an assessment of urogenital distress with a score range from 0 to 100, where higher scores indicate greater disability.|3 months|This analysis comprises only the participants who were randomized and had pre-PFPT and post-PFPT UDI-6 scores available|||units on a scale||Standard Deviation|Mean
2548508|NCT02875977|Secondary|Days to Initiation of PFPT|The number of days from referral to PFPT to the first PFPT visit is compared between those assigned to enhanced counseling versus standard counseling|3 months|This analysis comprises only the participants who were randomized and initiated PFPT|||Days||Inter-Quartile Range|Median
2548511|NCT02875977|Primary|Number of Participants With Completed PT Visits|The number of patients who completed at least half of their recommended PFPT visits is compared between those assigned to enhanced counseling versus standard counseling|3 months|This analysis comprises only the participants who were randomized and had follow-up PFPT completion information available|||Participants|||Count of Participants
2548512|NCT02875613|Primary|Overall Response Rate|Based on Response Evaluation Criteria in Solid Tumors (RECIST)|6 months||||Participants|||Count of Participants
2548513|NCT02875366|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)||Day 1 up to Week 28|The Safety Set was defined as all participants who received at least 1 dose of study drug.|||participants|||Number
2548514|NCT02875366|Secondary|Relative (Percent) Change From Baseline in Time Above Sedentary Duration at Week 24|Participants were provided with a wrist-worn actigraphy device which continuously collected data about daily activities and sleep duration and quality.|Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||percent change||Standard Deviation|Mean
2548515|NCT02875366|Secondary|Absolute Change From Baseline in Time Above Sedentary Duration at Week 24|Participants were provided with a wrist-worn actigraphy device which continuously collected data about daily activities and sleep duration and quality.|Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||hours||Standard Deviation|Mean
2548516|NCT02875366|Secondary|Relative (Percent) Change From Baseline in Duration of Sleep Time at Week 24|Participants were provided with a wrist-worn actigraphy device which continuously collected data about sleep duration and quality.|Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||percent change||Standard Deviation|Mean
2548517|NCT02875366|Secondary|Absolute Change From Baseline in Duration of Sleep Time at Week 24|Participants were provided with a wrist-worn actigraphy device which continuously collected data about sleep duration and quality.|Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||hours||Standard Deviation|Mean
2548518|NCT02875366|Secondary|Relative (Percent) Change From Baseline in Physical Activity as Determined by Actigraphy at Week 24|Participants were provided with a wrist-worn actigraphy device which continuously collected data about daily physical activities.|Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||percent change||Standard Deviation|Mean
2548519|NCT02875366|Secondary|Absolute Change From Baseline in Daily Physical Activity Counts as Determined by Actigraphy at Week 24|Participants were provided with a wrist-worn actigraphy device which continuously collected data about daily physical activity counts.|Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||physical activity counts per day||Standard Deviation|Mean
2548520|NCT02875366|Secondary|Number of Participants in Each Severity Category of Generalized Anxiety Disorder (GAD-7) Scores|The GAD-7 is a seven item, self-reported measurement of GAD severity. Each item is rated on a scale ranging from 0 (not at all) to 3 (nearly every day). Total score is the sum of individual seven items and ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms. Total score of 0 to 5 indicates none to minimal anxiety, 6 to 10 indicates mild anxiety, 11 to 15 indicates moderate anxiety, 16 to 21 indicates severe anxiety.|Baseline, Week 24|"FAS. Here Number Analyzed signifies those participants who were evaluated for this outcome at the specified time point."|||participants|||Number
2548521|NCT02875366|Secondary|Number of Participants in Each Severity Category of Patient Health Questionnaire (PHQ-8)|The PHQ-8 is an eight item self-reported measure of depression. Each item is rated on a scale ranging from 0 (not at all) to 3 (nearly every day). Total score is the sum of individual eight items and ranges from 0 to 24, with higher scores indicating more severe depression symptoms. Total score of 0 to 5 indicates none to minimal depression, 6 to 10 indicates mild depression, 11 to 15 indicates moderate depression, 16 to 20 indicates moderately severe depression and 21 to 24 indicates severe depression.|Baseline, Week 24|"FAS. Here Number Analyzed signifies those participants who were evaluated for this outcome at the specified time point."|||participants|||Number
2548522|NCT02875366|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Week 24|The CFQ-R assessed respiratory symptoms on a scale with scores ranging from 0 to 100; where higher scores indicated fewer symptoms and better health-related quality of life.|Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||units on a scale||95% Confidence Interval|Least Squares Mean
2548523|NCT02875366|Secondary|Relative (Percent) Change From Baseline in BMI at Week 24|BMI was defined as weight in kg divided by height in m^2.|Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||percent change||95% Confidence Interval|Least Squares Mean
2548524|NCT02875366|Secondary|Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilograms (kg) divided by height in square meter (m^2).|Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||kg/m^2||95% Confidence Interval|Least Squares Mean
2548525|NCT02875366|Secondary|Relative (Percent) Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||percent change||95% Confidence Interval|Least Squares Mean
2548526|NCT02875366|Secondary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||percentage of predicted FEV1||95% Confidence Interval|Least Squares Mean
2548527|NCT02875366|Secondary|Relative (Percent) Change From Baseline in Pulmonary Ventilation (VE) Versus Carbon Dioxide Production (VCO2) Slope at Week 24||Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||percent change||95% Confidence Interval|Least Squares Mean
2548528|NCT02875366|Secondary|Absolute Change From Baseline in Pulmonary Ventilation (VE) Versus Carbon Dioxide Production (VCO2) Slope at Week 24||Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||ratio||95% Confidence Interval|Least Squares Mean
2548529|NCT02875366|Secondary|Relative (Percent) Change From Baseline in Functional VO2 Gain at Week 24||Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||percent change||95% Confidence Interval|Least Squares Mean
2548530|NCT02875366|Secondary|Absolute Change From Baseline in Functional VO2 Gain at Week 24||Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||milliliter per minute per watt||95% Confidence Interval|Least Squares Mean
2548531|NCT02875366|Secondary|Relative (Percent) Change From Baseline in VO2 at Anaerobic Threshold at Week 24|Anaerobic threshold was defined as the exercise intensity at which lactate starts to accumulate.|Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||percent change||95% Confidence Interval|Least Squares Mean
2548532|NCT02875366|Secondary|Absolute Change From Baseline in Oxygen Consumption (VO2) at Anaerobic Threshold at Week 24|Anaerobic threshold was defined as the exercise intensity at which lactate starts to accumulate.|Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||milliliter per minute||95% Confidence Interval|Least Squares Mean
2548533|NCT02875366|Secondary|Absolute Change From Baseline in VO2max During CPET at Week 24|CPET was used to assess change in exercise tolerance, as measured by VO2max.|Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||milliliter per kilogram per minute||95% Confidence Interval|Least Squares Mean
2548534|NCT02875366|Secondary|Absolute Change From Baseline in Exercise Duration During CPET at Week 24|Exercise duration is defined as the time at the termination of CPET exercise minus the corresponding time when CPET starts for each CPET exercise.|Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||seconds||95% Confidence Interval|Least Squares Mean
2548535|NCT02875366|Secondary|Relative (Percent) Change From Baseline in Exercise Duration During CPET at Week 24|Exercise duration is defined as the time at the termination of CPET exercise minus the corresponding time when CPET starts for each CPET exercise.|Baseline, Week 24|"FAS. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||percent change||95% Confidence Interval|Least Squares Mean
2548536|NCT02875366|Primary|Relative (Percent) Change From Baseline in Maximal Oxygen Consumption (VO2max) During Cardiopulmonary Exercise Testing (CPET) at Week 24|CPET was used to assess change in exercise tolerance, as measured by VO2max.|Baseline, Week 24|"The Full Analysis Set (FAS) included all randomized participants who received any amount of study drug. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||percent change||95% Confidence Interval|Least Squares Mean
2548537|NCT02875340|Secondary|Overall Survival|Defined as the time from screening to death if the patient dies within the period that the site is open|6 months||||weeks||Full Range|Mean
2548538|NCT02875340|Secondary|Plasma VAL401 Half-life (t 1/2)|Assessment of plasma half-life of VAL401 (t 1/2) in collected blood samples on Day 1 and Day 15 of Cycle 1, collected at time points: pre-dose (0h) then 10, 15, 30 minutes, 1, 2, 4, 8, 10 and 24 hours after administration of VAL401.|1 Day and 2 weeks|"Pharmacokinetic measurements include total of Risperidone plus metabolite 9-hydroxy-Risperidone as total actives.~Note: 3 out of 8 patients completed PK analysis at Day 15, the remaining 5 patients did not undergo Day 15 PK analysis due to protocol deviations or early withdrawal from the trial."|||hours||Full Range|Mean
2548539|NCT02875340|Secondary|Trough Plasma Concentration (Cmin)|Assessment of trough plasma concentration (Cmin) in collected blood samples on Day 1 and Day 15 of Cycle 1, collected at time points: pre-dose (0h) then 10, 15, 30 minutes, 1, 2, 4, 8, 10 and 24 hours after administration of VAL401.|1 Day and 2 weeks|"Pharmacokinetic measurements include total of Risperidone plus metabolite 9-hydroxy-Risperidone as total actives.~Note: 3 out of 8 patients completed PK analysis at Day 15, the remaining 5 patients did not undergo Day 15 PK analysis due to protocol deviations or early withdrawal from the trial."|||ng/mL||Full Range|Mean
2548540|NCT02875340|Secondary|Peak Plasma Concentration (Cmax)|Assessment of Cmax in collected blood samples on Day 1 and Day 15 of Cycle 1, collected at time points: pre-dose (0h) then 10, 15, 30 minutes, 1, 2, 4, 8, 10 and 24 hours after administration of VAL401.|1 Day and 2 weeks|"Pharmacokinetic measurements include total of Risperidone plus metabolite 9-hydroxy-Risperidone as total actives~Note: 3 out of 8 patients completed PK analysis at Day 15, the remaining 5 patients did not undergo Day 15 PK analysis due to protocol deviations or early withdrawal from the trial."|||ng/mL||Full Range|Mean
2548541|NCT02875340|Secondary|Number of Patients With Disease Control|"Objective tumour response rates according to RECIST 1.1 for target lesions and assessed by CT:~Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD."|6 months|Participants scheduled to receive scans at screening, 3 months and 6 months. 2 participants attended CT scans at 3 months, or at their final visit (if earlier).|||Participants|||Count of Participants
2548542|NCT02875340|Secondary|Number of Participants Reporting Adverse Events and Serious Adverse Events|Ongoing evaluation of Adverse Events during treatment with VAL401. Events assessed for number of patients affected, severity of event, likelihood of event being related to the drug treatment and whether the event is an expected/known side effect of Risperidone.|6 months|Total number of patients reporting Adverse Events or Serious Adverse Events (excluding death)|||Participants|||Count of Participants
2548543|NCT02875340|Secondary|Patient Quality of Life During VAL401 Treatment|Changes in patient quality of life measured by EORTC Health-related Quality of Life (HRQoL) assessment questionnaire QLQ-C30 (Cancer specific questionnaire).|6 months|Each question is scored on a scale of 1 to 4, with each patient assessed for improvement or deterioration of Quality of Life for each life category stated. The number of patients, improving, deteriorating or remaining stable for each measure is reported out of the total of 8 patients assessed.|||Participants|||Count of Participants
2548544|NCT02875340|Primary|Progression-free Survival (PFS)|PFS is defined as the time from screening to disease progression (or death if the patient died before progression), with progression date nominally defined as the date the patient was withdrawn from the trial, where the Principal Investigator has determined by their professional discretion the patient has symptomatic disease progression.|6 months||||weeks||Full Range|Mean
2548545|NCT02875028|Secondary|Thrombomodulin|"thrombomodulin concentrations were measured by commercially available ELISA assays, individual maxima were compared between both study periods"|Time points for evaluation were: baseline, 0h, 2h, 4h, 6h, 24h|This was a crossover trial, so all subjects were to complete both study periods (vorapaxar and placebo period). The results of those periods were compared with each other. One subject withdrew during the washout period and was excluded from analysis.|||ng/mL||Inter-Quartile Range|Median
2548546|NCT02875028|Secondary|Platelet Factor 4|"platelet factor 4 concentrations were quantified by ELISA, individual maxima were compared between both study periods"|Time points for evaluation were: baseline, 0h, 2h, 4h, 6h, 24h|This was a crossover trial, so all subjects were to complete both study periods (vorapaxar and placebo period). The results of those periods were compared with each other. One subject withdrew during the washout period and was excluded from analysis.|||pg/mL||Inter-Quartile Range|Median
2548547|NCT02875028|Secondary|C-reactive Protein|C-reactive protein levels were measured in the certified central laboratory of the General Hospital, 24h values were compared with each other|Time points for evaluation were: baseline, and 24h after LPS administration|This was a crossover trial, so all subjects were to complete both study periods (vorapaxar and placebo period). The results of those periods were compared with each other. One subject withdrew during the washout period and was excluded from analysis.|||mg/dL||Inter-Quartile Range|Median
2548548|NCT02875028|Secondary|Tumor Necrosis Factor Alpha|"tumor necrosis factor alpha concentrations were measured using commercially available ELISA assays, individual maxima were compared between both study periods"|Time points for evaluation were: baseline, 0h, 2h, 4h, 6h, 24h|This was a crossover trial, so all subjects were to complete both study periods (vorapaxar and placebo period). The results of those periods were compared with each other. One subject withdrew during the washout period and was excluded from analysis.|||pg/mL||Inter-Quartile Range|Median
2548549|NCT02875028|Secondary|Interleukin 6|"interleukin-6 concentrations were measured by commercially available ELISA assays, individual maxima were compared between both study periods"|Time points for evaluation were baseline, 2h, 4h, 6h 24h after LPS administration|This was a crossover trial, so all subjects were to complete both study periods (vorapaxar and placebo period). The results of those periods were compared with each other. One subject withdrew during the washout period and was excluded from analysis.|||pg/mL||Inter-Quartile Range|Median
2548550|NCT02875028|Secondary|P-Selectin|"P-Selectin is quantified using commercially available ELISA assays, individual maxima were compared between both study periods."|Time points for evaluation were baseline, 2h, 4h, 6h 24h after LPS administration|This was a crossover trial, so all subjects were to complete both study periods (vorapaxar and placebo period). The results of those periods were compared with each other. One subject withdrew during the washout period and was excluded from analysis.|||ng/ml||Inter-Quartile Range|Median
2548551|NCT02875028|Secondary|Von Willebrand Factor|"von Willebrand factor concentrations were measured by commercially available ELISA assays, individual maxima were compared between both study periods. The result of this assay are % of normal (100%) for this specific assay. The unit therefore is %."|Time points for evaluation were baseline, 2h, 4h, 6h, 24h after LPS administration|This was a crossover trial, so all subjects were to complete both study periods (vorapaxar and placebo period). The results of those periods were compared with each other. One subject withdrew during the washout period and was excluded from analysis.|||"% of normal"||Inter-Quartile Range|Median
2548552|NCT02875028|Secondary|E-Selectin|"E-Selectin concentrations were quantified using commercially available ELISA assays, individual maxima were compared between both study periods"|Time points for evaluation were baseline, 2h, 4h, 6h, 24h after LPS administration|This was a crossover trial, so all subjects were to complete both study periods (vorapaxar and placebo period). The results of those periods were compared with each other. One subject withdrew during the washout period and was excluded from analysis.|||ng/mL||Inter-Quartile Range|Median
2548553|NCT02875028|Secondary|Plasmin-Antiplasmin Complexes|"Plasmin-Antiplasmin Complexes were quantified using commercially available ELISA assays. Individual maxima during both study periods were compared."|Time points for evaluation were: baseline, 0h, 2h, 4h, 6h, 24h|This was a crossover trial, so all subjects were to complete both study periods (vorapaxar and placebo period). The results of those periods were compared with each other. One subject withdrew during the washout period and was excluded from analysis.|||µg/L||Inter-Quartile Range|Median
2548554|NCT02875028|Secondary|Thrombin-Antithrombin Complexes|"Thrombin-Antithrombin Complexes were quantified using commercially available ELISA assays.~The individual maxima during the study periods were compared."|Time points for evaluation were: baseline, 0h, 2h, 4h, 6h, 24h|This was a crossover trial, so all subjects were to complete both study periods (vorapaxar and placebo period). The results of those periods were compared with each other. One subject withdrew during the washout period and was excluded from analysis.|||µg/L||Inter-Quartile Range|Median
2548555|NCT02875028|Secondary|Protease Activated Receptor (PAR)-1 Expression on Platelets|"Protease Activated Receptor (PAR)-1 expression on platelets was measured by flow cytometric analysis. The change in protease activated receptor (PAR)-1 expression over time was assessed. The ratio of protease activated receptor (PAR)-1 expression from baseline to 4h was the main parameter of interest and is presented here.~Since the presented data are ratios, the arbitrary unit is fold. Otherwise flow cytometric data is presented as hits during the analysis."|Time points for evaluation were: baseline, 0h, 4h, 24h|This was a crossover trial, so all subjects were to complete both study periods (vorapaxar and placebo period). The results of those periods were compared with each other. One subject withdrew during the washout period and was excluded from analysis.|||fold||Inter-Quartile Range|Median
2548556|NCT02875028|Primary|Changes in Prothrombin Fragments F1+2|prothrombin fragment F1+2 concentrations, individual maxima were compared between both study periods|Time points for evaluation were: baseline, 0h, 2h, 4h, 6h, 24h|This was a crossover trial, so all subjects were to complete both study periods (vorapaxar and placebo period). The results of those periods were compared with each other. One subject withdrew during the washout period and was excluded from analysis.|||pmol/L||Inter-Quartile Range|Median
2548557|NCT02874924|Other Pre-specified|Volume of Diastolic Filling|Diastolic function was assessed using Magnetic Resonance Imaging (MRI) of the heart to measure the diastolic filling of the heart in participants in the open label rapamycin group.|8 weeks|Cardiovascular effects were not measured in the Rapamycin versus placebo group, only open label rapamycin group.|||milliliters||Standard Deviation|Mean
2548558|NCT02874924|Other Pre-specified|Cardiovascular Effect|Pulse Wave Velocity is measured using an Electrocardiogram (ECG)|8 weeks|Due to technical problems with equipment, data were not captured for analysis.||||||
2548559|NCT02874924|Secondary|Cognitive Function|"The Executive Interview (EXIT25) - This test is a brief bedside test that consists of 25 items measuring abilities that include:~Executive functioning, Motor sequencing, Spoken alternate sequencing, Verbal fluency, Design fluency, Persistence, Resistance to interference, Reflexes Scoring directions are listed under each of the 25 portions of this test. For each section, the client is given a score of a 0, 1, or 2. A score 0 indicates no impairment, a score of 1 indicates some impairment, and a score of 2 indicates severe impairment. Directions for what qualifies as each score are listed under each section. The points are totaled and criteria are given for severe, moderate, and no impairment. Minimum score is -0- and maximum is 50. A score of 15 or below indicates normal executive functioning, a score of above 15 indicates moderate to severe impairment."|8 weeks|EXIT25 was not collected or analyzed in cardiovascular group.|||score on a scale||Standard Deviation|Mean
2548560|NCT02874924|Secondary|Physical Performance|walking speed: Timed 40-foot walk: each participant will perform 3 walks (timed with a stopwatch) at their preferred walking speed over a measured 40-foot path. Results will be averaged for analysis. The faster the walking speed the better the performance.|8 weeks|Walking speed was not analyzed in the cardiovascular group.|||Seconds||Standard Deviation|Mean
2548561|NCT02874924|Primary|Immunological Responses|T cell function measured by number of T cells per millimeter cubed.|8 weeks|In the cardiovascular arm, no T cell function was analyzed.|||cells/mm^3||Standard Deviation|Mean
2548562|NCT02874846|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||7 days (day 1/2 to day 8/9)|ITT|||Participants|||Count of Participants
2548563|NCT02874846|Primary|Change in Intraocular Pressure (IOP) Over Nocturnal Time Period|The primary efficacy endpoint was the mean change from baseline in mean nocturnal IOP (defined as the mean of the 4 nocturnal time points: 21:00, 00:00, 03:00, and 06:00 hours) on Day 8/Day 9|Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9|ITT|||mmHg||Standard Deviation|Mean
2548564|NCT02874794|Secondary|Change From Baseline in Echocardiographic Measure: Left Ventricular End Diastolic Volume Index (LVEDVi)|Parameter measured by echocardiography|Baseline, Week 12|Full Analysis Set|||mL/m2||Standard Error|Least Squares Mean
2548565|NCT02874794|Secondary|Change From Baseline in Echocardiographic Measure: Left Ventricular End Systolic Volume Index (LVESVi)|Parameter measured by echocardiography|Baseline, Week 12|Full Analysis Set|||mL/m2||Standard Error|Least Squares Mean
2548566|NCT02874794|Secondary|Change From Baseline in Echocardiographic Measure: Ventricular-vascular Coupling (Ea/Ees)|Parameter measured by echocardiography|Baseline, Week 12|Full Analysis Set|||Ea/Ees Ratio||Standard Error|Least Squares Mean
2548567|NCT02874794|Secondary|Change From Baseline in Echocardiographic Measure: Left Ventricular Ejection Fraction (LVEF)|Parameter measured by echocardiography|Baseline, Week 12|Full Analysis Set|||Percentage||Standard Error|Least Squares Mean
2548568|NCT02874794|Secondary|Change From Basekine in Echocardiographic Measure: Mitral E/E'|Parameter measured by echocardiography|Baseline, Week 12|Full Analysis Set|||Ratio||Standard Error|Least Squares Mean
2548569|NCT02874794|Secondary|Change From Baseline in Echocardiographic Measure: Mitral Annular E' Velocity (Doppler Tissue Imaging)|Parameter measured by echocardiography|Baseline, Week 12|Full Analysis Set|||cm/sec||Standard Error|Least Squares Mean
2548570|NCT02874794|Secondary|Change From Baseline in Echocardiographic Measure: Left Atrial Volume Index (LAVi)|Parameter measured by echocardiography|Baseline, Week 12|Full Analysis Set|||mL/m2||Standard Error|Least Squares Mean
2548571|NCT02874794|Secondary|Change From Baseline in Echocardiographic Measure: Global Longitudinal Strain|Parameter measured by echocardiography.|Baseline, Week 12|Full Analysis Set|||Percentage||Standard Error|Least Squares Mean
2548572|NCT02874794|Secondary|Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)|Change from baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)|Baseline, Week 12|Full Analysis Set|||pg/mL||95% Confidence Interval|Geometric Mean
2548573|NCT02874794|Secondary|Pearson Correlation Coefficient Between Change From Baseline in Aortic Characteristic Impedance and Biomarker Levels: cGMP/U-creatinine During Both Trough and 4 Hours Post-dose at Week 4|Pearson correlation coefficient between changes from baseline in aortic characteristic impedance (dyne x sec/cm5) and biomarker levels such as U-cGMP/U-creatinine ratio (nmol/mmol) during both trough and 4 hours post-dose at Week 4|pre-dose and 4 hours post dose at week 4|Full Analysis Set|||Pearson's correlation coefficient||95% Confidence Interval|Number
2548574|NCT02874794|Secondary|Pearson Correlation Coefficient Between Change From Baseline in Aortic Characteristic Impedance and Biomarker Levels: B-type Natriuretic Peptide (BNP) During Both Trough and 4 Hours Post-dose at Week 4|Pearson correlation coefficients between changes from baseline in aortic characteristic impedance (dyne x sec/cm5) and biomarker levels such as BNP (pg/ML) during both trough and 4 hours post-dose at Week 4|Pre-dose and 4 hours post dose at week 4|Full Analysis Set|||Pearson's Correlation||95% Confidence Interval|Number
2548575|NCT02874794|Primary|Change From Baseline in Aortic Characteristic Impedance at Week 12|Aortic characteristic impedance, Zc, is the ratio of the change in pressure (dP)produced by a given change in flow (dQ) in early systole, i.e., Zc = dP/dQ. Zc is related directly to aortic wall stiffness and inversely to lumen area.|Baseline, Week 12|Full Analysis Set|||dyne x sec/cm5||Standard Error|Least Squares Mean
2548592|NCT02874534|Secondary|Change From Baseline to Week 15 in Snaith-Hamilton Pleasure Scale Score|The Snaith-Hamilton Pleasure Scale (SHAPS), used to assess hedonic capacity. The sum of the 14 items scores ranges from 0 to 56. A higher score represents more anhedonic symptoms. The below means represent change in units on the Snaith-Hamilton Pleasure Scale.|Baseline, 15 weeks|The fMRI data quality for one participant was inadequate and was excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2552246|NCT02797522|Primary|Pharmacokinetics of ARC-521 Injection: Maximum Observed Plasma Concentration (Cmax), Healthy Volunteers||Through 48 hours post-dose on Day 1|Analysis was not planned or conducted per SAP due to study termination.||||||
2548576|NCT02874742|Secondary|Duration of Response|Duration of response is defined as the duration from the date of initial documentation of a response (PR or better) according to the IMWG criteria to the date of first documented evidence of progressive disease according to the IMWG criteria. PD is defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >= 0.5 g/dL and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.|From the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive (up to 2 years and 5 months)|ITT analysis set which included all randomized participants.|||Months||95% Confidence Interval|Median
2548577|NCT02874742|Secondary|Time to Progression (TTP)|TTP is defined as the duration from the date of randomization to the date of first documented evidence of progressive disease according to the IMWG criteria.|From randomization to the date of first documented evidence of progressive disease (up to 2 years and 5 months)|ITT analysis set which included all randomized participants.|||Months||95% Confidence Interval|Median
2548578|NCT02874742|Secondary|Overall Survival (OS)|OS is measured from the date of randomization to the date of the participant's death.|From randomization to the date of initial documentation of participant's death (up to 2 years and 5 months)|ITT analysis set which included all randomized participants.|||Months||95% Confidence Interval|Median
2548579|NCT02874742|Secondary|Progression-free Survival (PFS)|PFS is defined as the duration from the date of randomization to the date of first documented evidence of progressive disease or death, whichever comes first. PD is defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >= 0.5 g/dL and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.|Up to 24 months|ITT analysis set which included all randomized participants.|||Months||95% Confidence Interval|Median
2548580|NCT02874742|Secondary|Time to Partial Response (PR) or Better|Time to PR or better is the duration from the date of randomization to the date of initial documentation of PR or better, which was confirmed by a repeated measurement as required by the IMWG criteria.|From randomization to the date of initial documentation of PR or better (up to 2 years and 5 months)|Response-evaluable analysis set included all participants who had a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 dose of study treatment and had at least 1 post baseline disease assessment.|||Months||95% Confidence Interval|Median
2548581|NCT02874742|Secondary|Time to Very Good Partial Response (VGPR) or Better|Time to VGPR or better is the duration from the date of randomization to the date of initial documentation of VGPR or better, which was confirmed by a repeated measurement as required by the IMWG criteria.|From randomization to the date of initial documentation of VGPR or better (up to 2 years and 5 months)|Response-evaluable analysis set included all participants who had a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 dose of study treatment and had at least 1 post baseline disease assessment.|||Months||95% Confidence Interval|Median
2548582|NCT02874742|Secondary|Time to Complete Response or Better|Time to CR or better is the duration from the date of randomization to the date of initial documentation of CR or better, which was confirmed by a repeated measurement as required by the IMWG criteria.|From randomization to the date of initial documentation of CR (Up to 2 years and 5 months)|Response-evaluable analysis set included all participants who had a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 dose of study treatment and had at least 1 post baseline disease assessment.|||Months||95% Confidence Interval|Median
2548583|NCT02874742|Secondary|Time to Stringent Complete Response (sCR)|Time to sCR is the duration from the date of randomization to the date of initial documentation of sCR, which was confirmed by a repeated measurement as required by the IMWG criteria.|From randomization to the date of initial documentation of sCR (up to 2 years and 5 months)|Response-evaluable analysis set included all participants who had a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 dose of study treatment and had at least 1 post baseline disease assessment.|||Months||95% Confidence Interval|Median
2548584|NCT02874742|Secondary|Duration of Stringent Complete Response (sCR)|Duration of sCR is the duration from the date of initial documentation of a sCR response, according to the IMWG criteria, to the date of first documented evidence of progressive disease, or relapse from sCR. PD is defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M component (absolute increase must be >= 0.5 g/dL and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.|From randomization to the date of first documented evidence of progressive disease or relapse from sCR (up to 2 years and 5 months)|Population analyzed included response evaluable analysis set who achieved response PR or better.|||Months||95% Confidence Interval|Median
2548610|NCT02873754|Primary|Number of Participants Whose Prolonged Abstinence is Bio-verified|Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.|3 month follow up|5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures. No participants reported prolonged abstinence, so bioverification wasn't completed.||||||
2560606|NCT02662569|Secondary|Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at Week 12||Baseline and week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2548585|NCT02874742|Secondary|Duration of Complete Response|Duration of CR is the duration from the date of initial documentation of a CR response, according to the IMWG criteria, to the date of first documented evidence of progressive disease (PR), or relapse from CR. PD is defined as an increase of 25 % from the lowest response value in one of the following: serum and urine M-component (absolute increase must be greater than or equal to [>=] 0.5 gram per deciliter [g/dL] and >=200 milligram [mg]/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to Plasma cell (PC) proliferative disorder.|From randomization to the date of first documented evidence of progressive disease or relapse from CR (up to 2 years and 5 months)|Population analyzed included response evaluable analysis set who achieved response (PR or better).|||Months||95% Confidence Interval|Median
2548586|NCT02874742|Secondary|Percentage of Participants With Negative Minimal Residual Disease (MRD)|Minimal residual disease negative rate is defined as the percentage of participants who achieve MRD negative status by the respective time point. Minimal residual disease was evaluated in participants who achieved CR or sCR (including participants with VGPR or better and suspected daratumumab interference) using next-generation sequencing which utilizes multiple myeloma cell DNA from bone marrow aspirates at a threshold of less than (<) 10^5.|From randomization to end of following: induction treatment, post-ASCT consolidation (after Cycle 6) (up to 4.5 months)|Intent to treat (ITT) analysis set which included all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2548587|NCT02874742|Secondary|Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better|VGPR or better rate is defined as the percentage of participants who achieved VGPR or better, according to the IMWG criteria. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours.|From randomization to end of following: induction treatment, ASCT, post-ASCT consolidation (after Cycle 6) and during maintenance treatment (up to 24 months)|Population analyzed included response evaluable analysis set who achieved response (PR or better).|||Percentage of participants||95% Confidence Interval|Number
2548588|NCT02874742|Secondary|Percentage of Participants With Overall Response Rate (ORR)|ORR -percentage of participants who achieved partial response (PR) or better (PR, Very Good Partial Response [VGPR], CR or sCR) based on computerized algorithm as per IMWG criteria. PR -greater than or equal to (>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg//24 hours. If serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required. A >=50% reduction in the size of soft tissue plasmacytomas is also required; VGPR-serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours; CR-negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. sCR- in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry.|From randomization to end of following: induction treatment, ASCT, post-ASCT consolidation (after Cycle 6) and during maintenance treatment (up to 24 months)|Response-evaluable analysis set included all participants who had a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 dose of study treatment and had at least 1 post baseline disease assessment.|||Percentage of participants||95% Confidence Interval|Number
2548589|NCT02874742|Secondary|Percentage of Participants With Overall Stringent Complete Response (sCR)|Overall sCR rate is defined as the percentage of participants who achieved sCR, according to the IMWG criteria. CR is defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and < 5 % PCs in bone marrow. sCR is defined as in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry.|From randomization to end of following: induction treatment, ASCT, post-ASCT consolidation (after Cycle 6) and during maintenance treatment (up to 24 months)|Response-evaluable analysis set included all participants who had a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 dose of study treatment and had at least 1 post baseline disease assessment.|||Percentage of participants||95% Confidence Interval|Number
2548590|NCT02874742|Secondary|Percentage of Participants With Overall Complete Response (CR)|Overall CR rate is defined as the percentage of participants who achieve CR, according to the IMWG criteria. CR is negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and < 5% PCs in bone marrow.|From randomization to end of following: induction treatment, ASCT, post-ASCT consolidation (after Cycle 6) and during maintenance treatment (up to 24 months)|Response-evaluable analysis set included all participants who had a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 dose of study treatment and had at least 1 post baseline disease assessment.|||Percentage of participants||95% Confidence Interval|Number
2548591|NCT02874742|Primary|Percentage of Participants With Stringent Complete Response (sCR)|Percentage of participants who have achieved sCR as determined by the validated computer algorithm according to the International Myeloma Working Group (IMWG) criteria, by the end of post-autologous stem cell transplantation (post-ASCT) consolidation treatment were reported. Complete response (CR) is defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (<) 5 percent (%) PCs in bone marrow. sCR is defined as in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry.|From randomization to post-ASCT consolidation (after Cycle 6) before maintenance treatment (up to 10 months)|Response-evaluable analysis set included all participants who had a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 dose of study treatment and had at least 1 post baseline disease assessment. The outcome measure was planned to be reported for randomized participants only.|||Percentage of participants||95% Confidence Interval|Number
2549022|NCT02862548|Primary|Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR) at Week 24 Using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Equation||Baseline; Week 24|Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.|||mL/min/1.73 m^2||Standard Deviation|Mean
2548593|NCT02874534|Primary|Change From Baseline to Week 15 in Neural Activation|Change due to BATA, relative to MBCT, from baseline in right caudate nucleus activation during the anticipation phase of the Monetary Incentive Delay (MID) task assessed by Functional Magnetic Resonance Imaging (fMRI). The BOLD (Blood Oxygen Level-Dependent signal change is expressed as a z-score that represents the magnitude of change relative to baseline. A score of 0 would correspond to no change, and a score of 1 would represent 1 standard deviation of change. The difference in z-scores between the BATA and the MBCT groups reflects the difference in change in fMRI responses between the two treated groups. Thus even a score of 0 in the BATA group may reflect greater change than observed in the MBCT group if change in the MBCT group is negative.|Baseline, 15 weeks|The fMRI data quality for one participant was inadequate and was excluded from the analysis.|||Z-score||Standard Deviation|Mean
2548594|NCT02874404|Secondary|Estimated Progression-free Survival (PFS) at 6 Months|PFS is defined as the time between study registration and documented progression or death if no progression was observed.|Time between study registration and documented progression or death if no progression was observed, assessed up to 4 years (6 Month estimate shown)||||percentage of participants||95% Confidence Interval|Number
2548595|NCT02874404|Secondary|Overall Response Rate (ORR)|"ORR is defined as number of patients achieving a best response of complete response or partial response at any disease assessment time point. Response is based on PET/CT (Deauville 3 or less) or CT alone if CR is achieved by PET/CT. Response criteria, modified from the Lugano response criteria. DLBCL is considered FDG avid.~Complete response:~Complete disappearance of all detectable clinical evidence of disease and definitely disease-related symptoms if present before therapy.~Criteria for Partial Response (PR):~Regression of measurable disease and no new sites"|Up to 4 years||||Participants|||Count of Participants
2548596|NCT02874404|Primary|Percentage of Participants With Adverse Events Assessed Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03|Notable serious or recurrent adverse events (SAEs or AEs) of interest occurring across all cycles regardless of attribution|Up to 112 days (course 4)||||percentage of participants|||Number
2548597|NCT02874066|Secondary|Number of Participants With End-of-treatment Virological Response (EOTVR)|Number of participants with undetectable serum HCV RNA at week 12 of treatment|12 weeks||||Participants|||Count of Participants
2548598|NCT02874066|Secondary|Number of Participants With Rapid Virologic Response (RVR)|Number of participants with undetectable serum HCV RNA at week 4 of treatment|4 weeks||||Participants|||Count of Participants
2548599|NCT02874066|Secondary|Number of Participants With Sustained Virologic Response (SVR24)|Number of participants with undetectable serum HCV RNA 24 weeks off therapy (treatment period 12 weeks)|36 weeks||||Participants|||Count of Participants
2548600|NCT02874066|Secondary|Number of Participants With Treatment-emergent Adverse Event (AE)-Related Withdrawal Rate|Number of participants with treatment-emergent adverse event (AE)-related withdrawal rate during the study|12 weeks||||Participants|||Count of Participants
2548601|NCT02874066|Primary|Number of Participants With Sustained Virologic Response (SVR12)|Number of participants with undetectable serum HCV RNA 12 weeks off therapy (treatment period 12 weeks)|24 weeks|Patients who received at least one dose of PTV/r/OBV/DSV|||Participants|||Count of Participants
2548602|NCT02873754|Secondary|Number of Quit Smoking Attempts|Participants will self-report the number of quit attempts they've had since baseline.|3 month follow up|These data were only available for 2 participants.|||quit attempts||Standard Deviation|Mean
2548603|NCT02873754|Secondary|Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit|Self-reported number of cigarettes smoked each day in past 7 days; this will be compared to self-reported amount smoked in week prior to quit date|3 month follow up|Only one participant completed the timeline follow-back procedure at 3 months|||cigarettes|||Number
2548604|NCT02873754|Secondary|Change in the Number of Days in Which Smoked Compared to Pre-quit Use|Participants will self-report number of days smoked in the past 30 days and this will be compared to self-reported number of days smoked in 30 days prior to quit.|3 month follow up|These data were only available for one participant.|||days|||Number
2548605|NCT02873754|Secondary|Change in Physical Activity From Baseline to 3-month Follow-up as Measured by the Stanford 7-day Physical Activity Recall (PAR) Scale.|Participants will be interviewed about the amount of time spent in light, moderate, and hard physical activity during the past 7 days. Total number of days of moderate and hard exercise in last 7 days will be compared to self-reported values at baseline (i.e., # of days of exercise in past 7 days at 3-month follow-up minus # of days of exercise in past 7 days at baseline).|baseline and 3 month follow up|Data are only available for two participants.|||days||Standard Deviation|Mean
2548606|NCT02873754|Secondary|Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking|30-day point prevalence abstinence is defined as no smoking in the prior 30 days.|3 month follow up|5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.|||Participants|||Count of Participants
2548607|NCT02873754|Secondary|Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking|7-day point prevalence abstinence is defined as no smoking in the prior 7 days.|3 month follow up|5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.|||Participants|||Count of Participants
2548608|NCT02873754|Secondary|Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking|30-day point prevalence abstinence is defined as no smoking in the prior 30 days.|6 month follow up|5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.|||Participants|||Count of Participants
2548609|NCT02873754|Secondary|Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking|7-day point prevalence abstinence is defined as no smoking in the prior 7 days.|6 month follow up|5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.|||Participants|||Count of Participants
2548667|NCT02872311|Primary|HI Titers, HD vs. AD, Yr 2 Day 28 Post Vaccination|Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2017-18|Year 2, Day 28 post vaccination|This primary objective evaluated only recipients in the arms receiving high dose and adjuvanted vaccine in year 1.|||Titer||95% Confidence Interval|Geometric Mean
2548611|NCT02873754|Primary|Number of Participants Who Self-report Prolonged Abstinence From Smoking|Participants will be asked to report on smoking since two weeks past quit date. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.|3 month follow up|5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.|||Participants|||Count of Participants
2548612|NCT02873754|Primary|Number of Participants Whose Prolonged Abstinence is Bio-verified|Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.|6 month follow up|5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures. Two participants didn't self-report abstinence, so bioverification was not completed.|||Participants|||Count of Participants
2548613|NCT02873754|Primary|Number of Participants Who Self-report Prolonged Abstinence From Smoking|Participants will be asked to report on smoking since two weeks past quit date. Prolonged abstinence is defined as continued abstinence from smoking beginning at 2 weeks post-quit.|6 month follow up|5 participants were withdrawn from analyses because they were lost to contact before study completion. One was withdrawn by the PI because he couldn't perform study procedures.|||Participants|||Count of Participants
2548614|NCT02873702|Secondary|Maintenance Period: Percentage of Participants Who Maintained Complete Healing of EE at Month 6|Percentage of participants with complete healing of EE was assessed by endoscopy. EE was graded according to the LA classification of esophagitis grading system, based on the extent of visible mucosal breaks seen in the esophagus according to the following: Grade O (no mucosal breaks); Grade A (>=1 mucosal break no longer than 5 mm that does not extend between the tops of 2 mucosal folds); Grade B (>=1 mucosal break >5 mm that does not extend between the tops of 2 mucosal folds); Grade C (>=1 mucosal break that is continuous between the tops of 2 or more mucosal folds, but involves <75% of the circumference); Grade D (>=1 mucosal break which involves >=75% of the circumference). Healing is defined as LA Grade O.|Month 6|The full analysis set for the maintenance period (FAS-M) included all participants with healed EE by week 8 who were randomized and received at least 1 dose of study drug during 6 months of maintenance treatment.|||percentage of participants|||Number
2548615|NCT02873702|Primary|Healing Period: Percentage of Participants With Complete Healing of EE at Week 8|Percentage of participants with complete healing of EE was assessed by endoscopy. EE was graded according to the Los Angeles (LA) classification of esophagitis grading system, based on the extent of visible mucosal breaks seen in the esophagus according to the following: Grade O (no mucosal breaks); Grade A (>=1 mucosal break no longer than 5 millimeter [mm] that does not extend between the tops of 2 mucosal folds); Grade B (>=1 mucosal break greater than [>] 5 mm that does not extend between the tops of 2 mucosal folds); Grade C (>=1 mucosal break that is continuous between the tops of 2 or more mucosal folds, but involves <75 percent (%) of the circumference); Grade D (>=1 mucosal break which involves >=75% of the circumference). Healing is defined as LA Grade O.|Week 8|The FAS-H included all randomized participants who had documented EE at screening and had received at least 1 dose of study drug during the first 8 weeks of treatment.|||percentage of participants|||Number
2548616|NCT02873689|Secondary|Percentage of Days Without Nighttime Heartburn During Treatment|The percentage of days without nighttime heartburn was = (the days that were heartburn-free during the treatment period) / (total number of days for which nighttime result was marked during treatment period)*100%.|Up to Week 4|Full analysis set included all randomized participants who received at least 1 dose of study drug and had post-baseline (post Day-1) data for the appropriate efficacy variables.|||percentage of days||Full Range|Median
2548617|NCT02873689|Primary|Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment|The percentage of days with neither daytime nor nighttime heartburn was equal to (=) (the days that were heartburn-free during the treatment period) / (total number of days for which either a daytime or nighttime result was marked during treatment period)*100 percent (%).|Up to Week 4|Full analysis set included all randomized participants who received at least 1 dose of study drug and had post-baseline (post Day-1) data for the appropriate efficacy variables.|||percentage of days||Full Range|Median
2548618|NCT02873481|Secondary|Recruitment Feasibility|Numbers of women who agreed to participate in the study;|at intervention completion, an average of 20 weeks||||participants|||Number
2548619|NCT02873481|Secondary|Number of Subjects Participating in Focus Group|Women will volunteer to discuss their experiences (acceptability) with the intervention through focus groups conducted following the intervention period|at intervention completion, an average of 20 weeks||||Participants|||Count of Participants
2548620|NCT02873481|Secondary|Stress|Perceived Stress Scale (PSS): The Perceived Stress Scale-10 (PSS-10), a widely used, psychometrically sound instrument, will assess the degree to which a participant perceives stress in her life during the past month. The PSS-10 asks respondents to report about feelings such as unpredictability, uncontrollability, and overloading of stress in their lives; scores range from 0-40; higher scores correspond to a higher perceived stress level.|baseline (early pregnancy), end of pregnancy (approx 10 months)||||units on a scale||Standard Deviation|Mean
2548621|NCT02873481|Secondary|Depressive Symptoms|Patient Health Questionnaire-9 (PHQ9): The PHQ-9 includes self-report items regarding depressive symptoms over the past two weeks. Total scores range from 0-27, where 0-4 indicates minimal depression, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately severe depressive symptoms, and ≥20 severe depressive symptoms.|baseline (early pregnancy), end of pregnancy (approx 10 months)||||units on a scale||Standard Deviation|Mean
2548622|NCT02873481|Secondary|Salivary Biomarkers (α-amylase)|"salivary biomaker measure. This is an exploratory measure related to acute stress, yet it does not currently have known clinical associations with certain numeric levels of this measure (i.e., there is no identified high or low level of alpha-amylase). Only collected in the intervention group."|baseline (early pregnancy), mid-pregnancy (approx 4-5 months), end of pregnancy (approx 10 months)||||U/mL||Standard Deviation|Mean
2548768|NCT02869438|Secondary|Change From Baseline to Post Baseline for Pre-BD FVC|Post baseline visits include Day 3, Day 7, Day 14, Day 28, Day 56, and Day 84.|From first IP dose to Day 84|Full analysis set|||Liter||Standard Deviation|Mean
2548623|NCT02873481|Secondary|Self-efficacy for Physical Activity|Physical Activity Self-Efficacy Scale (PASES): The Physical Activity Self-Efficacy Scale (PASES) is an 8 question scale which contains items about SM of physical activities and social support regarding PA. This psychometrically sound scale was selected because of its specific focus on SM of PA. Originally designed for adolescents, the wording has been slightly adapted for an adult sample. A higher score indicates higher levels of self-efficacy. Lowest possible score is 8; highest possible score is 40. Only participants in the intervention arm receive this particular instrument.|baseline (early pregnancy), end of pregnancy (approx 10 months)||||units on a scale||Standard Deviation|Mean
2548624|NCT02873481|Primary|Feasibility of Retention/ Adherence|Numbers of women who stayed in the study through their pregnancy and attended all intervention sessions|through study completion, an average of 20 weeks||||Participants|||Count of Participants
2548625|NCT02873429|Secondary|Clinical Global Impression of Change (CGI)|Patient's rating of current symptom level compared to baseline assessment using a five-point bipolar scale: Much better(2), Somewhat better(1), No change(0), Somewhat worse(-1), Much worse(-2)|6-8 weeks||||participants|||Number
2548626|NCT02873429|Primary|PROMIS Pain Interference|"Computerized adaptive test measuring interference of pain in everyday functioning using five-point Likert-type scales with two types or response options (i.e., not at all=1, a little bit=2, somewhat=3, quite a bit=4, very much=5, and never=1, rarely=2, sometimes=3, often=4, always=5). Scores on the items are summed to create a raw score. The raw score is converted to a T-score metric in which 50 is the mean of the relevant reference population and 10 is the standard deviation (SD) of that population.(see http://www.healthmeasures.net for details of CAT administration and scoring)."|6-8 weeks||||T-score metric||Standard Deviation|Mean
2548627|NCT02873429|Primary|PROMIS Pain Intensity|PROMIS Pain Intensity is a three item scale measuring the severity of pain at its worst (past week), average (past week), and current level using a five-point Likert-type scale (i.e., no pain=1, mild=2, moderate=3, severe=4, very severe=5). Scores on the 3 items are summed to create a raw score, which can range from 3 to 15. The raw score is converted to a T-score metric in which 50 is the mean of the relevant reference population and 10 is the standard deviation (SD) of that population.(see http://www.healthmeasures.net/promis-scoring-manuals for details ).|6-8 weeks||||T-score metric||Standard Deviation|Mean
2548628|NCT02873377|Secondary|Change in Number of Cigarettes Smoked|For the participants that did not quit, the change in number of cigarettes smoked will be reported as the number of cigarettes smoked per day at the 6 months follow up visit minus the number of cigarettes smoked per day at baseline|Baseline, 6-month||||Cigarettes smoked per day||Standard Deviation|Mean
2548629|NCT02873377|Secondary|Rate of Compliance to Intervention|Rate of compliance to intervention is reported as the percentage of participants who self-reported following intervention components at follow-up.|6-month||||Percentage of participants|||Number
2548630|NCT02873377|Secondary|Questionnaire Response Rate|Questionnaire response rate will be reported by the percentage of participants that completed the initial and follow up questionnaire.|6-month||||Percentage of participants|||Number
2548631|NCT02873377|Secondary|Follow-Up Rate|Follow up rate will be reported as the percentage of participants that completed their follow up visit.|3-month, 6-month||||Percentage of participants|||Number
2548632|NCT02873377|Secondary|Quitline Response Rate|Quitline Response will be reported by the percentage of participants that contacted the Quitline, enrolled in the tobacco Quitline and the participants that completed at least 1 phone call from Tobacco Quitline.|6-month||||Percentage of participants|||Number
2548633|NCT02873377|Secondary|Enrollment Rate|Enrollment rate will be reported as the percentage of participants that were eligible and randomized against the participants screened.|Baseline|Number of workers screened|||Percentage of participants|||Number
2548634|NCT02873377|Secondary|7-day Point- Prevalence Prolonged Abstinence Rate|Point prevalence abstinence rates is defined as self report of not smoking; in the past 7 days not even a puff) confirmed by saliva cotinine level of <15ng/ml.|6-month||||Percentage of participants|||Number
2548635|NCT02873377|Primary|Prolonged Abstinence Rates|Prolonged abstinence is defined as no smoking, not even a puff, after a grace period of two weeks after quit date. This will be assessed in follow up questionnaire and confirmed with saliva cotinine level of <15 ng/ml.|6-month||||Percentage of participants|||Number
2548636|NCT02873221|Secondary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) Using 5-Point Scales|"On the C-SSRS, the 5 types of suicidal ideation are:~Type 1: Wish to be dead Type 2: Non-specific active suicidal thoughts Type 3: Active suicidal ideation with any methods (not plan) without intent to act Type 4: Active suicidal ideation with some intent to act, without specific plan Type 5: Active suicidal ideation with specific plan and intent"|56 Weeks|"The Safety population is defined separately below for the ubrogepant arms and the usual-care arm.~Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm"|||Participants|||Count of Participants
2548637|NCT02873221|Secondary|Number of Participants With Clinically Significant Vital Sign Measurements|Vital sign measurements considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.|56 Weeks|"The Safety population is defined separately below for the ubrogepant arms and the usual-care arm.~Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm"|||Participants|||Count of Participants
2548638|NCT02873221|Secondary|Number of Participants With Clinically Significant Electrocardiograms (ECGs) Findings|ECG findings considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.|56 Weeks|"The Safety population is defined separately below for the ubrogepant arms and the usual-care arm.~Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm"|||Participants|||Count of Participants
2548639|NCT02873221|Secondary|Number of Participants With Clinically Significant Laboratory Values|Hematology, Chemistry and Urinalysis results considered potentially clinically significant (PCS) meeting either the lower-limit or higher-limit PCS criteria.|56 Weeks|"The Safety population is defined separately below for the ubrogepant arms and the usual-care arm.~Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm"|||Participants|||Count of Participants
2548640|NCT02873221|Primary|Percentage of Participants With at Least 1 Treatment Emergent Adverse Event|An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.|56 Weeks|"The Safety population is defined separately below for the ubrogepant arms and the usual-care arm.~Ubrogepant arms: All randomized patients who received ≥ 1 dose of treatment. Usual care arm: All randomized patients in the usual-care arm."|||Percentage of Participants|||Number
2548641|NCT02873195|Secondary|The Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Event Deemed at Least Possibly Related to Treatment (Toxicity)|The number of participants who experienced at least one grade 3 or higher adverse event deemed at least possibly related to treatment (toxicity) is reported below. Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Toxicities will be evaluated via the ordinal CTCAE standard toxicity grading.|Up to 20 months|Participants who started treatment and are evaluable for adverse events are included in this analysis.|||Participants|||Count of Participants
2548642|NCT02873195|Secondary|Objective Response Rate|The objective response rate is defined as the percentage of participants who achieve a partial response or compete response as assessed (partial response [PR] or complete response [CR] per RECIST v1.1) during treatment with study therapy. Rates of response will be compared across arms using a fisher's exact test for proportion. Point estimates will be generated for objective response rates within each arm along with 95% binomial confidence intervals. Complete response (CR): Disappearance of all evidence of disease, Partial response (PR): Regression of measurable disease and no new sites|Up to 20 months|Modified Intent-to-treat (ITT) population|||percentage of participants||95% Confidence Interval|Number
2548643|NCT02873195|Secondary|Overall Survival (OS)|The distribution of survival time will be estimated using the method of Kaplan-Meier. OS will be compared between treatment arms using the unstratified log-rank test. OS medians, survival rates and HR will be estimated along with 95% confidence intervals.|From randomization to death due to any cause, assessed up to 20 months|Modified Intent-to-treat (ITT) population|||months||95% Confidence Interval|Median
2548644|NCT02873195|Primary|Progression Free Survival (PFS)|Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The primary comparisons will be superiority of the active treatment for PFS of atezolizumab versus placebo. PFS will be compared between treatment arms using the un-stratified log-rank test at one-sided level of 0.10 and the p-value will be used for decision making. The hazard ratio (HR) for PFS will be estimated using a Cox proportional hazards model and the 95% confidence interval (CI) for the HR will be provided. Kaplan-Meier methodology will be used to estimate the median PFS for each treatment arm, and Kaplan-Meier curves will be produced. Progression is defined as any new lesion or increase by ≥20% of previously involved sites from nadir based on RECIST criteria.|From randomization to first documentation of disease progression by RECIST v1.1, or death from any cause, assessed up to 20 months|Modified Intent-to-treat (ITT) population|||months||95% Confidence Interval|Median
2548645|NCT02873104|Secondary|Subject Discomfort and Pain Levels During Treatment|"Comparison of the average pain levels during treatment for the sham group and therapeutic group at 12 weeks post-treatment, using a 0 - 10 scale where 0 equals No pain and 10 equals Worst possible pain."|12 weeks||||units on a scale||Standard Deviation|Mean
2548646|NCT02873104|Secondary|Subject Satisfaction Level for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment.|"Comparison of the average subject satisfaction level for the sham group and therapeutic group at 12 weeks post-treatment, using a 1 - 5 scale where 1 equals very dissatisfied and 5 equals very satisfied."|12 weeks||||units on a scale||Standard Deviation|Mean
2548647|NCT02873104|Secondary|Subject Assessment of Improvement for Both Sham Group and Therapeutic Group at 12 Weeks Post-treatment.|"Comparison of the average subject improvement score for the sham group and the therapeutic group at 12 weeks post-treatment using a 0 - 4 improvement scale where 0 equals no change and 4 equals Very Significant Improvement."|12 weeks||||units on a scale||Standard Deviation|Mean
2548648|NCT02873104|Primary|Difference in Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment|Change in Abdominal Circumferential Measurement Related to Sham and Therapeutic Group at 12 Weeks Post-treatment minus Baseline Measurement|12 weeks||||cm||Standard Error|Mean
2548649|NCT02872909|Secondary|Patient Satisfaction|"brief patient questionnaire to evaluate their opinion of the treatment they received. This is assessed as A.efficacy of treatment - 1 = not effective NR; 2 = partIally effective PR; 3 = completely effective CR; B.Side effects of treatment eg. pain and inflammation - 1 = severe; 2 = moderate; 3 = mild; 4 = none/minimal. C.Practicalities of treatment eg. ease of use, travel, time, inconvenience - 1 = very disruptive and difficult; 2 = moderately disruptive and difficult; 3 = minimally disruptive and difficult. The scores of A, B and C will be added to give an overall score with range of overall minimum score option 3 and maximum 10.~Patients will also separately be asked to give overall evaluation on a VAS scale of 0 = treatment very poor and would not have again through to 10 = treatment excellent and I would have again - with a continuous line option from 0 - 10 to mark across, providing a separate score with range options 0 to 10"|one year after treatment - last visit||||score on a scale||Full Range|Median
2548650|NCT02872909|Secondary|Clinical Clearance of Lesion|clinical assessment by study dermatologist to determine by inspection and palpation whether the lesion is clear, partially clear or not clear - assessed at 3, 6 and 12 months after treatment, with 12 months as the final study outcome endpoint analysed|12 months after treatment||||Participants|||Count of Participants
2548651|NCT02872909|Secondary|Phototoxicity|"erythema, oedema, blistering, crusting, ulceration on semi-quantitative scale. Erythema is graded as 0 = absent, 1 = mild, 2 = moderate or 3 = severe erythema as assessed by naked eye examination. Oedema is graded as 0 = absent or 1 = present. Likewise crusting or ulceration are each graded as 0 = absent and 1 = present by naked eye examination. Data will be presented and analysed separately ie. erythema data will be presented and then separately whether oedema, crusting or ulceration are present or absent.~ie. reporting may appear as example: erythema score 3 of range of 0-3 options; oedema score 1 (binary option of 0 or 1); crusting score 0 (binary option of 0 or 1); ulceration score 0 (binary option of 0 or 1)"|one week after treatment||||score on a scale||Full Range|Median
2548652|NCT02872909|Primary|Pain on VAS Score|assess on visual analogue scale (VAS) score of 0 - 10cm, with 0 representing no pain experienced through to 10 representing the worst pain imaginable. The participant marks across a 0-10cm unmarked line where their level of pain experience is and this is measured eg. 2cm if experiencing mild pain or 8.5cm which would represent severe pain|one week after treatment|The ambulatory devices suffered technical failure in the first two participants so no data were available for these subjects. Data were available for 32 participants treated with ambulatory PDT and 18 treated with conventional PDT|||score on a scale||Inter-Quartile Range|Median
2548653|NCT02872311|Secondary|Number of Participants With Vaccine Failure, Year 2|Number of Participants with Vaccine Failure in Year 2 by two-year vaccine history|Year 2, Post season|Results of influenza surveillance after the second year examines individuals by groups based on the vaccine types received in both seasons.|||Participants|||Count of Participants
2548654|NCT02872311|Secondary|Number of Participants With Vaccine Failure, Year 1|Number of Participants with Vaccine Failure in Year 1 by vaccine type|Year 1, Post season|Results of influenza surveillance after the first year examines individuals by the vaccine type received in Year 1.|||Participants|||Count of Participants
2548655|NCT02872311|Secondary|HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 182 Post Vaccination|Hemagglutination inhibition (HI) titers among HD and AD based on prior season vaccination (standard or sequential same vaccination) at 182 days after vaccination, 2017-18|Year 2, Day 182 post vaccination|This secondary objective selects individuals receiving high dose or adjuvanted vaccine in year 2 of the study and compares immune response by vaccine received in the prior season.|||Titer||95% Confidence Interval|Geometric Mean
2548656|NCT02872311|Secondary|HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 28 Post Vaccination|Hemagglutination inhibition (HI) titers among HD and AD based on prior season vaccination (standard or sequential same vaccination) at 28 days after vaccination, 2017-18|Year 2, Day 28 post vaccination|This secondary objective selects individuals receiving high dose or adjuvanted vaccine in year 2 of the study and compares immune response by vaccine received in the prior season.|||Titer||95% Confidence Interval|Geometric Mean
2548657|NCT02872311|Secondary|HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 182 Post Vaccination|Hemagglutination Inhibition (HI) titers to vaccine viruses among adjuvant, high dose and recombinant recipients with prior season standard dose vaccine at 182 days post vaccination 2017-18|Year 2, Day 182 post vaccination|This secondary objective aimed to look at subjects receiving standard dose vaccine in the previous season and one of 3 licensed vaccines in the 2017-18 season.|||Titer||95% Confidence Interval|Geometric Mean
2548658|NCT02872311|Secondary|HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 28 Post Vaccination|Hemagglutination Inhibition (HI) titers to vaccine viruses among adjuvant, high dose and recombinant recipients with prior season standard dose vaccine at 28 days post vaccination 2017-18|Year 2, Day 28 post vaccination|This secondary objective aimed to look at subjects receiving standard dose vaccine in the previous season and one of 3 licensed vaccines in the 2017-18 season.|||Titer||95% Confidence Interval|Geometric Mean
2548659|NCT02872311|Secondary|MN Titers (A/Hong Kong (Siat Cell)), HD vs. AD, Year 2, Day 28 Post Vaccination|Microneutralization antibody titers to vaccine virus (A/Hong Kong (siat cell) among high dose and adjuvanted vaccine recipients 28 days post vaccination, 2017-18|Year 2, Day 28 post vaccination|Secondary objective examines response in adjuvant and high dose recipients to A/Hong Kong (siat cell) virus in year 2, post vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2548660|NCT02872311|Secondary|MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination|Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 365 days post vaccination, 2016-17|Year 1, Day 365 post vaccination|Secondary objective examines response in adjuvant and high dose recipients to vaccine and drifted viruses.|||Titer||95% Confidence Interval|Geometric Mean
2548661|NCT02872311|Secondary|MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination|Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 182 days post vaccination, 2016-17|Year 1, Day 182 post vaccination|Secondary objective examines response in adjuvant and high dose recipients to vaccine and drifted viruses.|||Titer||95% Confidence Interval|Geometric Mean
2548662|NCT02872311|Secondary|MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination|Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 28 days post vaccination, 2016-17|Year 1, Day 28 post vaccination|Secondary objective examines response in adjuvant and high dose recipients to vaccine and drifted viruses.|||Titer||95% Confidence Interval|Geometric Mean
2548663|NCT02872311|Secondary|HI Response by Prior Season Vaccination, Yr 1, Day 365 Post Vaccination|Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 365 days post vaccination, 2016-17|Year 1, Day 365 post vaccination|Secondary objective examines response in adjuvant and high dose recipients by prior season vaccination status.|||Titer||95% Confidence Interval|Geometric Mean
2548664|NCT02872311|Secondary|HI Response by Prior Season Vaccination, Yr 1, Day 182 Post Vaccination|Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 182 days post vaccination, 2016-17|Year 1, Day 182 post vaccination|Secondary objective examines response in adjuvant and high dose recipients by prior season vaccination status.|||Titer||95% Confidence Interval|Geometric Mean
2548665|NCT02872311|Secondary|HI Response by Prior Season Vaccination, Yr 1, Day 28 Post Vaccination|Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 28 days post vaccination, 2016-17|Year 1, Day 28 post vaccination|Secondary objective examines response in adjuvant and high dose recipients by prior season vaccination status.|||Titer||95% Confidence Interval|Geometric Mean
2548666|NCT02872311|Primary|HI Titers, HD vs. AD, Yr 2 Day 182 Post Vaccination|Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2017-18|Year 2, Day 182 post vaccination|This primary objective evaluated only recipients in the arms receiving high dose and adjuvanted vaccine in year 1.|||Titer||95% Confidence Interval|Geometric Mean
2548769|NCT02869438|Secondary|Change From Baseline (Visit 4) to Post Baseline Visits in Pre-BD FEV1|Post baseline visits include Day 3, Day 7, Day 14, Day 28, Day 56, Day 84. [Note: Day 28, 56, 84 are presented in the Primary measure.]|From first IP dose to Day 84|Full analysis set|||Liter||Standard Deviation|Mean
2548668|NCT02872311|Primary|HI Titers, HD vs. AD, Yr 1 Day 365 Post Vaccination|Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 365 days post vaccination 2016-17|Year 1, Day 365 post vaccination|This primary objective evaluated only recipients in the arms receiving high dose and adjuvanted vaccine in year 1.|||Titer||95% Confidence Interval|Geometric Mean
2548669|NCT02872311|Primary|HI Titers, HD vs. AD, Yr 1 Day 182 Post Vaccination|Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2016-17|Year 1, Day 182 post vaccination|This primary objective evaluated only recipients in the arms receiving high dose and adjuvanted vaccine in year 1.|||Titer||95% Confidence Interval|Geometric Mean
2548670|NCT02872311|Primary|HI Titers, HD vs. AD, Yr 1 Day 28 Post Vaccination|Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2016-17|Year 1, Day 28 post vaccination|This primary objective evaluated only recipients in the arms receiving high dose and adjuvanted vaccine in year 1.|||Titer||95% Confidence Interval|Geometric Mean
2548671|NCT02872285|Secondary|The Number of Subjects Who Achieve a 2 Step Reduction on the Static Investigators Global Assessment (IGA) at Week 12.|This endpoint is based on number of subjects who achieved a 2 step reduction in the static IGA at week 12 (ie, a score of 5 at baseline to a score of 3 or less at Week 12). The static IGA is used to measure psoriasis severity. The static IGA used in this study was a 6-point scale: 0 = Cleared [no plaque elevation, erythema or scaling, hyperpigmentation may be present]; 1 = Minimal [minimal plaque elevation (=0.25mm), faint erythema, minimal scaling with occasional fine scale over < 5% of lesion]; 2 = Mild [mild plaque elevation (=0.5mm), light red coloration, fine scale predominates]; 3 = Moderate [moderate plaque elevation (=0.75mm), moderate red coloration, coarse scale predominates]; 4 = Marked (marked plaque elevation (=1mm), bright red coloration, thick non-tenacious scale predominates]; 5 = Severe (severe plaque elevation (≥1.25mm), dusky to deep red coloration, very thick tenacious scale predominates].|12 weeks|The full analysis set included all randomized subjects. Randomized subjects included in this analysis had to have both a baseline and a Week 12 static IGA score.|||Participants|||Count of Participants
2548672|NCT02872285|Secondary|"The Number of Subjects Who Achieve Cleared (Score = 0) or Minimal (Score = 1) on the Static Investigators Global Assessment at Week 12."|This endpoint is number of subjects who achieved a score of 0 or 1 on the static IGA at week 12. The static IGA is used to measure psoriasis severity. The static IGA used in this study was a 6-point scale: 0 = Cleared [no plaque elevation, erythema or scaling, hyperpigmentation may be present]; 1 = Minimal [minimal plaque elevation (=0.25mm), faint erythema, minimal scaling with occasional fine scale over < 5% of lesion]; 2 = Mild [mild plaque elevation (=0.5mm), light red coloration, fine scale predominates]; 3 = Moderate [moderate plaque elevation (=0.75mm), moderate red coloration, coarse scale predominates]; 4 = Marked (marked plaque elevation (=1mm), bright red coloration, thick non-tenacious scale predominates]; 5 = Severe (severe plaque elevation (≥1.25mm), dusky to deep red coloration, very thick tenacious scale predominates].|12 weeks|The full analysis set included all randomized subjects. Randomized subjects included in this analysis had to have both a baseline and a Week 12 static IGA score.|||Participants|||Count of Participants
2548673|NCT02872285|Secondary|The Mean Percent Change From Baseline to Week 12 in Percent Body Surface Area (BSA).|Mean percent change from baseline to Week 12 in %BSA was calculated by taking the Week 12 %BSA and subtracting the baseline %BSA then dividing by the baseline %BSA and multiplying by 100. The mean percent change from baseline to Week 12 in each treatment group were compared using analysis of covariance with treatment as a factor and baseline as a covariate.|Baseline to Week 12|The full analysis set included all randomized subjects. Randomized subjects included in this analysis had to have both a baseline and a Week 12 %BSA score.|||percent change||Standard Deviation|Mean
2548674|NCT02872285|Secondary|The Number of Subjects Who Achieve a ≥ 75% Reduction From Baseline in PASI at Week 12.|"This endpoint calculated the number of subjects achieving a ≥ 75% reduction in their Week 12 PASI score compared to their baseline PASI.~The PASI is a measure of chronic plaque-type psoriasis disease. It combines lesion severity (erythema, thickness, scaling) and skin surface area involvement in 4 defined anatomical body regions (head, upper extremities, trunk, lower extremities). PASI score ranges from 0 to 72 with higher scores indicative of greater disease severity. Lesion severity (erythema, thickness, scaling) is scored on a scale of 0 (none) to 4 (very severe) on each of the 4 body regions. Degree of skin area involvement in each body region is scored on a scale of 0 (no involvement) to 6 (90-100% involvement)."|Baseline to Week 12|The full analysis set included all randomized subjects. Randomized subjects included in this analysis were those with PASI scores at baseline and at Week 12.|||Participants|||Count of Participants
2548675|NCT02872285|Primary|The Mean Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI).|This endpoint was calculated in each treatment group by taking the Week 12 PASI score and subtracting the baseline PASI and dividing by the baseline PASI, then multiplying by 100 to get the percent change from baseline. The PASI is a measure of chronic plaque-type psoriasis disease. It combines lesion severity (erythema, thickness, scaling) and skin surface area involvement in 4 defined anatomical body regions (head, upper extremities, trunk, lower extremities). PASI score ranges from 0 to 72 with higher scores indicative of greater disease severity. Lesion severity (erythema, thickness, scaling) is scored on a scale of 0 (none) to 4 (very severe) on each of the 4 body regions. Degree of skin area involvement in each body region is scored on a scale of 0 (no involvement) to 6 (90-100% involvement).|Baseline to Week 12|The full analysis set included all randomized subjects. Randomized subjects included in this analysis had to have both a baseline and a Week 12 PASI score.|||percent change||Standard Deviation|Mean
2548676|NCT02872103|Secondary|Number of Participants With Use of Antibiotics and Pain Medications|Antibiotics and pain medications use will be recorded for each chemotherapy cycle and overall cycles|4 chemotherapy cycles, about 12 weeks|3 subjects terminated early|||Participants|||Count of Participants
2548677|NCT02872103|Secondary|Number of Participants With Infections for Each Chemotherapy Cycle and Over All Cycles.|The number of subjects with infections for each arm of the study will be recorded for each and all 4 chemotherapy cycles.|4 chemotherapy cycles, about 12 weeks|Some subjects terminated earlier|||Participants|||Count of Participants
2548678|NCT02872103|Secondary|The Depth of the ANC Nadir for Each Chemotherapy Cycle and Over All Cycles.|The depth of ANC nadir for each cycle is the minimal ANC value (× 10^9/L ) for a patient in each chemotherapy cycle|4 chemotherapy cycles, about 12 weeks|3 subjects terminated early.|||cells/10^9/L||Standard Deviation|Mean
2548679|NCT02872103|Secondary|The Time in Days to ANC Recovery Post Nadir for Each Chemotherapy Cycle and Over All Cycles; Recovery Defined as an ANC ≥ 2.0 × 10^9/L After the Expected ANC Nadir.|The time to ANC recovery post nadir for each patient, for each of their chemotherapy cycles will be recorded. Recovery for this protocol is defined as achieving an ANC ≥ 2.0 × 10^9/L after the expected ANC nadir (expected nadir is typically 4-6 days post chemotherapy administration).|4 chemotherapy cycles, about 12 weeks|3 Subjects terminated early (1 in F-627 arm, 2 in the placebo arm). In addition, 1 subject in placebo arm reached her Nadir(1.81) at Day 7 but the rest of ANC values are missing. Because the recovery information is not available, this subject was removed from the Time to ANC recovery analysis.|||days||Standard Deviation|Mean
2548680|NCT02872103|Secondary|Number of Participants With Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy Cycles.|The number of subjects with grade 2, 3 and 4 neutropenia will be recorded for all 4 chemotherapy cycles.|4 chemotherapy cycles, about 12 weeks||||Participants|||Count of Participants
2548681|NCT02872103|Secondary|Number of Participants With Febrile Neutropenia (FN) for Each Chemotherapy Cycle and Over All Cycles|Febrile neutropenia is defined as a single oral temperature of ≥38.3°C (101°F) or a temperature of >38.0°C (100.4°F) sustained for >1 hour and ANC < 0.5 x 10^9/L|4 chemotherapy cycles, about 12 weeks|3 subjects terminated early.|||Participants|||Count of Participants
2548682|NCT02872103|Secondary|The Duration in Days of Grade 2 (Mild), Grade 3 (Moderate) and 4 (Severe) Neutropenia Over All Cycles.|The duration in days of mild, moderate and severe neutropenia will be recorded for 4 chemotherapy cycles. Grade 2 neutropenia is when a patient's ANC<1.5x10^9/L, Grade 3 neutropenia is when a patient's ANC<1.0x10^9/L, and Grade 4 neutropenia is when a patient's ANC <0.5x10^9/L.|4 chemotherapy cycles, about 12 weeks||||days||Standard Deviation|Mean
2548683|NCT02872103|Secondary|The Duration in Days of Grade 4 (Severe) Neutropenia (ANC < 0.5 × 10^9/L) for Chemotherapy Cycles 2, 3, and 4, and Over All Cycles.|The duration of severe neutropenia will be measured for each patient during chemotherapy cycle 2-4 and over all cycles. Each chemotherapy is expected to last 21 days.|Over all 4 cycles, about 12 weeks|Missing ANC data. No multiple imputation|||days||Standard Deviation|Mean
2548684|NCT02872103|Primary|The Duration in Days of Grade 4 (Severe) Neutropenia Observed in Chemotherapy Cycle 1 in Comparison to Placebo|Subjects will be randomized to F-627 or Placebo at 2:1 ratio. About 24 hours after chemotherapy, subjects will either receive 20mg fixed dose F-627 or Placebo. The subject's absolute neutrophil count (ANC) will be monitored each day post chemotherapy administration until the ANC level exceeds 2.0x10^9/L, then the value will be monitored every three days until the next chemotherapy cycle is entered. The duration of grade 4 neutropenia (ANC <0.5x10^9/L) in this cycle is the primary efficacy endpoint.|The first of 4, 21 Day Chemotherapy Cycles, an average of 3 weeks||||days||Standard Deviation|Mean
2548685|NCT02872012|Primary|Subjective Injection Pain|Immediately after receiving the intravitreal injection, patient's will be asked to rate their pain on the Visual Analogue (Pain) Scale. The scale ranges from 0 to 10. 0 meaning no pain and 10 meaning the worst possible pain.|Immediately following the intravitreal injection||||units on a scale||Standard Error|Mean
2548686|NCT02871739|Primary|Change in Braddock's Informed Decision Making Score|Transcripts from standardized patient interactions (SPI) will be scored using Braddock's Informed Decision Making (IDM) framework to assess shared decision making skills. Scores with the Braddock's Informed Decision Making Framework range from 0 to 9; the higher scores are better. We subtracted the scores of the baseline SPI collected before the intervention from the second SPI collected 4-6 weeks later, after the intervention, to determine the change in IDM score for each participant and then compared change scores across study arms.|Baseline (before intervention) and 4-6 weeks (after intervention)||||score on a scale||Standard Deviation|Mean
2548687|NCT02871570|Other Pre-specified|Time for Maximum Observed Concentration (Tmax) of Rivipansel||Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1|The PK parameter analysis population included all participants treated who had at least one of the PK parameters of primary interest.|||hours||Full Range|Median
2548688|NCT02871570|Secondary|Volume of Distribution at Steady State (Vss) of Rivipansel|Vss of rivipansel was calculated as CL*MRT, where MRT was the mean residence time and CL was the clearance from plasma.|Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1|The PK parameter analysis population included all participants treated who had at least one of the PK parameters of primary interest.|||liters||Geometric Coefficient of Variation|Geometric Mean
2548689|NCT02871570|Secondary|Terminal Half-Life of Rivipansel|Terminal half-life of rivipansel was calculated as loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.|Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1|The PK parameter analysis population included all participants treated who had at least one of the PK parameters of primary interest.|||hours||Standard Deviation|Mean
2548690|NCT02871570|Secondary|Maximum Observed Concentration (Cmax) of Rivipansel||Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1|The PK concentration population included all participants treated who had at least 1 PK concentration.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2548691|NCT02871570|Primary|Total Clearance From Plasma (CL) of Rivipansel|CL of rivipansel was calculated as dose/AUCinf, where AUCinf referred to the area under the plasma concentration-time profile from time 0 extrapolated to the infinite time.|Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1|The PK parameter analysis population included all participants treated who had at least one of the PK parameters of primary interest.|||liter/hour||Geometric Coefficient of Variation|Geometric Mean
2548692|NCT02871570|Secondary|Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Rivipansel|Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of rivipansel was determined using a linear/log trapezoidal method.|Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1|The PK parameter analysis population included all participants treated who had at least one of the PK parameters of primary interest.|||hr*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2548770|NCT02869438|Secondary|Percent Change From Baseline to End of Treatment in Eosinophils Counts|Percent change from baseline to Day 84|From first IP dose to Day 84|Full analysis set|||Percent change||Full Range|Mean
2548693|NCT02871570|Primary|Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Rivipansel|AUCinf was calculated as AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log linear regression analysis, kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1|The pharmacokinetic (PK) parameter analysis population included all participants treated who had at least one of the PK parameters of primary interest.|||hour*microgram/milliliter (hr*mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2548694|NCT02871570|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)|Laboratory tests included: hematology (hemoglobin, hematocrit, red and white blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, prothrombin time/international normalized ratio), chemistry (blood urea nitrogen/urea and creatinine, fasting glucose, calcium, sodium, potassium, chloride, total carbon dioxide, aspartate and alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein), urinalysis (pH, qualitative glucose, protein, and blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, and microscopy), and other tests (follicle stimulating hormone, urine drug test and serologic tests on human immunodeficiency virus-1 antibody, Hepatitis B surface antigen and hepatitis C antibody). Abnormality was determined by the investigator using widely accepted criteria in clinical practice.|Day 5|Safety analysis set included all participants who received study medication.|||participants|||Number
2548695|NCT02871570|Primary|Number of Participants With Vital Signs Data Meeting Pre-defined Summarization Criteria|Absolute values and changes from baseline (increase and decrease) were summarized for supine diastolic blood pressure (DBP), supine systolic blood pressure (SBP), and supine pulse rate. Number of participants with vital signs findings meeting the following criteria is presented: (1) supine DBP <50 millimeters of mercury (mm Hg); (2) supine DBP >90 mm Hg; (3) supine SBP <90 mm Hg; (4) supine SBP >140 mm Hg (for normal hepatic function group); (5) supine SBP >160 mm Hg (for moderate hepatic impairment group); (6) supine pulse rate < 40 beats per minute (bpm); (7) supine pulse rate >120 bpm; (8) supine DBP increase from baseline >=20 mm Hg; (9) supine SBP increase from baseline >=30 mmHg; (10) supine DBP decrease from baseline >=20 mm Hg; (11) supine SBP decrease from baseline >=30 mm Hg.|Day 1 to Day 5|Safety analysis set included all participants who received study medication.|||participants|||Number
2548696|NCT02871570|Primary|Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Summarization Criteria|Maximum absolute values and increases from baseline were summarized for PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization), QRS duration (time from Q wave to the end of S wave, corresponding to ventricle depolarization), and QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula). Number of participants with ECG findings meeting the following criteria is presented: (1) PR interval >=300 msec; (2) QRS duration >=200 msec; (3) QTcF interval: 450 to <480 msec; (4) QTcF interval: 480 to <500 msec; (5) QTcF interval >=500 msec; (6) PR interval percent increase from baseline >=25/50 percent; (7) QRS duration percent increase from baseline >=50 percent; (8) QTcF interval increase from baseline: 30 to <60 msec; (9) QTcF interval increase from baseline >=60 msec.|Day 5|Safety analysis set included all participants who received study medication.|||participants|||Number
2548697|NCT02871570|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between administration of study medication and up to follow-up visit (28-31 days after administration) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs.|Day 1 to follow-up visit (28-31 days after administration of study medication on Day 1)|Safety analysis set included all participants who received study medication.|||participants|||Number
2548698|NCT02871570|Primary|Number of Participants With Post-baseline Clinically Significant Findings in Physical Examinations|A full physical examination was performed for each participant, and it included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes and gastrointestinal, musculoskeletal, and neurological systems. Clinical significance of laboratory findings was determined by the investigator.|Day 5|Safety analysis set included all participants who received study medication.|||participants|||Number
2548699|NCT02871479|Secondary|Percentage of Subjects Who Have a ≥ 50% Reduction in the Eczema Area and Severity Index (EASI) Score|Percentage of subjects who have a ≥ 50% reduction in the Eczema Area and Severity Index (EASI) score at any point during the trial. Minimum value is a 0 and a maximum value is 72. Higher score denoting worse than a lower score.|28 days|The FAS group was used for this outcome measure|||Participants|||Count of Participants
2548700|NCT02871479|Primary|Number of Patients With Adverse Events|Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.|28 days|The FAS group was used for this outcome measure|||Participants|||Count of Participants
2548701|NCT02871375|Secondary|Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score|The abbreviated CLDEQ-8 is an 8-item questionnaire used to assess comfort and dryness. Total CLDEQ-8 score ranged from 0 to 37, where a lower score represented less symptomology.|Day 14, each product|Full Analysis Set. Number Analyzed is the number of subjects with non-missing responses.|||units on a scale||Standard Deviation|Mean
2548702|NCT02871375|Primary|Binocular High Contrast/High Illumination (HC/HI) Visual Acuity (VA) at Intermediate Distance (80 cm)|Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HC/HI VA was assessed binocularly (both eyes together) at 80 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR). A lower logMAR value indicates better visual acuity.|Day 14, each product|Full Analysis Set. Number Analyzed is the number of subjects with non-missing responses.|||logMAR||Standard Deviation|Mean
2548703|NCT02871011|Secondary|Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31|"Clinical Symptom Severity Score change in score on Day and Day 31 between all participants with an initial Clinical Symptom severity Score of >20 (0-64 scale) in the two study groups.~Increased improvement is expressed as largest negative change and a lower score."|Day 1 and 31|Intent to treat enrollment was 20 individuals.|||Clinial symptom Severity Score||Standard Deviation|Mean
2548704|NCT02871011|Primary|Incidence of Adverse Events|Number of moderate A/E possibly related to treatment|Duration of the study, 31 days for each participant.|Intent to treat enrollment was 20 individuals.|||Events|||Number
2548705|NCT02871011|Primary|Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8.|Positive fungi colonization via mycological culture OR microscopic evaluation (KOH) AND a post treatment Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 31. Improvement is expressed as a lower score.|Day 31|Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline.|||Participants|||Count of Participants
2548706|NCT02871011|Primary|Number of Participants With Therapeutic Failure: Post Treatment (Day 17)|Positive fungi colonization via mycological culture OR microscopic evaluation (KOH) AND a post treatment Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 17. Improvement is expressed as a lower score.|Day 17|Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline.|||Participants|||Count of Participants
2548707|NCT02871011|Primary|Number of Participants With Complete Cure: Post Treatment (Day 31)|Complete cure will be determined by a minimum of a 12- point reduction on day 17 in the Clinical Symptom Severity Score (from >20 to <8) on a scale of 0-64. Improvement is expressed as a lower score.|Day 31|Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline.|||Participants|||Count of Participants
2548708|NCT02871011|Primary|Number of Participants With Complete Cure: Post Treatment (Day 17)|Complete cure will be determined by negative fungal culture or negative microscopic evaluation via KOH preparation and a Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 17. Improvement is expressed as a lower score.|Day 17|Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline.|||Participants|||Count of Participants
2548709|NCT02870933|Secondary|Left Ventricle End Diastolic Volume|"Left ventricle end-diastolic volume is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricle just before systole.~Normal ranges of LVEDV is 121 - 163 mililiters"|Baseline, 6 months||||milliliters||Standard Deviation|Mean
2548710|NCT02870933|Secondary|Minnesota Living With Heart Failure Questionnaire|"Quality of life assessed using Minnesota Living With Heart Failure Questionnaire consist of 21 questions, to see the changes before and after intervention.~Minimum score = 0, Maximum score = 105 Higher values represent a worse outcome"|Baseline, 6 months||||score on a scale||Inter-Quartile Range|Median
2548711|NCT02870933|Secondary|Left Ventricle End Systolic Volume|"Left ventricle end-systolic volume is the volume of blood in a left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.~Normal LVESV ranges is 37 - 57 mililiters."|Baseline, 6 months||||milliliters||Standard Deviation|Mean
2548712|NCT02870933|Secondary|Vascular Endothelial Growth Factor|Cytokine that has important role for angiogenesis. Normal range for plasma VEGF is 0-115 pg/ml|Baseline, 6 months||||pg/ml||Standard Deviation|Mean
2548713|NCT02870933|Secondary|Myocardial Scar Size|"Percentage of myocardial scar size proportion measured by MRI to quantify and define the extent/transmurality of scar tissue, the following definitions were used~spatial (circumferential) extent, the number of affected segments~nontransmurality, the number of segmments with a segmental scar score of 1 or 2, and transmurality, the number of segments with a segmental scar score of 3 or 4~total score, summed segmental scar scores per patient divided by 17 (which reflects the damage per patient)"|Baseline, 6 months||||Percentage of Scar Area||Standard Deviation|Mean
2548714|NCT02870933|Secondary|Wall Motion Score Index|"Cardiac wall motion abnormality will be measured using Wall Motion Score Index with MRI. Each myocardial segment is assigned a score from 1 to 4. The 16 segment model of myocardial segmentation is recommended.~A WMSI of 1.0 is considered normokinetic. A WMSI of 1.5 is considered mild hypokinesia A WMSI of 2.0 is considered hypokinesia A WMSI of 2.5 is considered severe hypokinesia A WMSI of 3.0 is considered akinetic."|Baseline, 6 months||||score on a scale||Standard Deviation|Mean
2548715|NCT02870933|Secondary|Six Minutes Walking Test|Quality of life will be assessed using Six minutes walking test, to see the changes of six minutes walking test before and after intervention Distances reported for healthy individuals ages 40 yo 85 years range from 400 to 700 m..|Baseline, 6 months||||meters||Inter-Quartile Range|Median
2548716|NCT02870933|Primary|Left Ventricular Ejection Fraction|Left ventricular ejection fraction (LVEF) measured by MRI. Normal range of LVEF ranges from 50% to 70%. Borderline LVEF ranges from 41% to 49% Reduced LVEF ranges < 41%|Baseline, 6 months||||percentage of ejection fraction||Standard Deviation|Mean
2548717|NCT02870933|Primary|Myocardial Defect Perfusion|Number of heart wall segments with perfusion defect measured by MRI.|Baseline, 6 months||||Percentage of Myocardial Perfusion||Standard Deviation|Mean
2548718|NCT02870205|Primary|Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS)|The Reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Symptom scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).|Baseline and day 14|The FAS was defined as all subjects who were randomized and received at least one dose of investigational product and had at least one post-baseline primary efficacy assessment. This was the primary analysis set for efficacy analyses.|||units on a scale||Standard Deviation|Mean
2549023|NCT02862106|Secondary|Change From Baseline by Vsit for HBeAg Titer.|Measuring the change in value of each visit viewpoints HBeAg titers decreased compared with baseline values|week95,108,120,144|intend to treat population|||IU/ML||Standard Deviation|Mean
2548719|NCT02870101|Primary|Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum|NAAT 3 index test results include negative, positive, equivocal, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 2 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.|One day|Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from this outcome.|||Participants|||Count of Participants
2548720|NCT02870101|Primary|Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx|NAAT 3 index test results include negative, positive, equivocal, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 2 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.|One day|Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.|||Participants|||Count of Participants
2548721|NCT02870101|Primary|Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum|NAAT 2 index test results include negative, positive, equivocal, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.|One day|Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from analysis.|||Participants|||Count of Participants
2548722|NCT02870101|Primary|Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx|NAAT 2 index test results include negative, positive, equivocal, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.|One day|Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.|||Participants|||Count of Participants
2548723|NCT02870101|Primary|Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Rectum|NAAT 1 index test results include negative, positive, and no result. ASIS reference results are the combination of the NAAT 2 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.|One day|Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from this outcome.|||Participants|||Count of Participants
2548724|NCT02870101|Primary|Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Chlamydia Trachomatis (CT) in Pharynx|NAAT 1 index test results include negative, positive, and no result. ASIS reference results are the combination of the NAAT 2 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.|One day|Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.|||Participants|||Count of Participants
2548725|NCT02870101|Primary|Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum|NAAT 3 index test results include negative, positive, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 2 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.|One day|Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from this outcome.|||Participants|||Count of Participants
2548726|NCT02870101|Primary|Number of Participants With Nucleic Acid Amplification Test (NAAT) 3 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx|NAAT 3 index test results include negative, positive, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 2 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.|One day|Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.|||Participants|||Count of Participants
2548727|NCT02870101|Primary|Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum|NAAT 2 index test results include negative, positive, equivocal, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.|One day|Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from this outcome.|||Participants|||Count of Participants
2548728|NCT02870101|Primary|Number of Participants With Nucleic Acid Amplification Test (NAAT) 2 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx|NAAT 2 index test results include negative, positive, equivocal, and no result. ASIS reference results are the combination of the NAAT 1 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid|One day|Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.|||Participants|||Count of Participants
2548729|NCT02870101|Primary|Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Rectum|NAAT 1 index test results include negative, positive, and no result. ASIS reference results are the combination of the NAAT 2 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.|One day|Of the 2598 participants who completed the overall study per the Participant Flow module, 13 participants had incomplete test results and were excluded from this outcome.|||Participants|||Count of Participants
2548730|NCT02870101|Primary|Number of Participants With Nucleic Acid Amplification Test (NAAT) 1 Index Test Results Relative to Anatomic Site Infection Status (ASIS) Reference Results for Neisseria Gonorrhoeae (NG) in Pharynx|NAAT 1 index test results include negative, positive, and no result. ASIS reference results are the combination of the NAAT 2 and NAAT 3 index test results. ASIS reference results include negative, positive, indeterminate, and invalid.|One day|Of the 2598 participants who completed the overall study per the Participant Flow module, 8 participants had incomplete test results and were excluded from this outcome.|||Participants|||Count of Participants
2548731|NCT02869451|Secondary|Number of Voluntary Withdrawals From the Project|The number of participants who withdraw from the study will be evaluated as a measure of treatment feasibility and acceptability|Evaluated at 6 month follow-up||||Participants|||Count of Participants
2548732|NCT02869451|Secondary|Number of Missed Behavioral Counseling Sessions|Participants attend telephone counseling sessions. Number of missed sessions for the total group will be assessed as a measure of acceptability of the behavioral counseling|3 month follow up||||missed counseling sessions|||Number
2548733|NCT02869451|Secondary|Percentage of Missing Mobile Contingency Management Video Recordings|Participants upload video recordings of abstinence verification as part of contingency management treatment. Percentage of missed videos (compared to expected videos) will be assessed as a measure of feasibility of the contingency management intervention|3 month follow up||||percent missed video recordings|||Number
2548734|NCT02869451|Secondary|Proportional Change in Days Smoked From Pre-quit to 6-month Follow up (for Entire Group)|Participants will self-report number of days smoked in the past 30 days and this will be compared (for the entire group) to self-reported number of days smoked in 30 days prior to quit. The proportion will be calculated by totaling baseline days used and pretreatment days used, and then dividing baseline days used by pretreatment days used.|30 days prior to quit date, 6 month follow up||||percentage of pre-quit use|||Number
2548735|NCT02869451|Secondary|Change in Number of Cigarettes Smoked Per Week Compared to Pre-quit|Self-reported number of cigarettes smoked each day in past 7 days; this will be compared to self-reported amount smoked in week prior to quit date|7 days prior to quit date, 6 month follow up||||number of cigarettes per wk||Standard Deviation|Mean
2548736|NCT02869451|Secondary|Proportional Change in Days of Cannabis Use From Pre-quit to 6 Month Follow-up (Entire Group)|Participants will self-report number of days marijuana used in the past 30 days and this will be compared for the entire group to self-reported number of days of use in 30 days prior to quit. The proportion will be calculated by totaling baseline days used and pretreatment days used, and then dividing baseline days used by pretreatment days used.|30 days prior to quit date, 6 month follow up||||percentage of pre-quit use|||Number
2548737|NCT02869451|Secondary|Change From Baseline in Number of Days Per Week of Cannabis Use|Participants will self-report amount of marijuana used in past week; this will be compared to self-reported amount smoked per week prior to quit date.|baseline, 6 month follow up||||days per week of marijuana use||Standard Deviation|Mean
2548738|NCT02869451|Secondary|Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Salivary Cotinine|Self-reported abstinence (primary outcome) will be verified by oral fluid (OF) cannabis assessment. Oral fluid samples will be collected from participants who self-report prolonged abstinence.|3 month follow up||||Participants|||Count of Participants
2548739|NCT02869451|Secondary|Number of Participants Who Report Smoking Abstinence and Abstinence is Bioverified by Salivary Cotinine|Self-reported abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.|3 month follow up||||Participants|||Count of Participants
2548740|NCT02869451|Secondary|Number of Participants Who Report 7 Day Point Prevalence Abstinence From Marijuana|7-day point prevalence abstinence is defined as no marijuana use in the prior 7 days.|3 month follow up||||Participants|||Count of Participants
2548741|NCT02869451|Secondary|Number of Participants Who Report 7 Day Point Prevalence Abstinence From Smoking|7-day point prevalence abstinence is defined as no smoking in the prior 7 days.|3 month follow up||||Participants|||Count of Participants
2548742|NCT02869451|Secondary|Number of Participants Who Report 30 Day Point Prevalence Abstinence From Smoking|30-day point prevalence abstinence is defined as no smoking in the prior 30 days.|6 month follow up||||Participants|||Count of Participants
2548743|NCT02869451|Secondary|Number of Participants Who Report 30 Day Point Prevalence Abstinence From Marijuana|30-day point prevalence abstinence is defined as no marijuana use in the prior 30 days.|6 month follow up||||Participants|||Count of Participants
2548744|NCT02869451|Secondary|Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Marijuana|7-day point prevalence abstinence is defined as no marijuana use in the prior 7 days.|6 month follow up||||Participants|||Count of Participants
2548745|NCT02869451|Secondary|Number of Participants Who Self-report 7 Day Point Prevalence Abstinence From Smoking|7-day point prevalence abstinence is defined as no smoking in the prior 7 days.|6 month follow up||||Participants|||Count of Participants
2548746|NCT02869451|Primary|Number of Participants Who Report Marijuana Abstinence and Abstinence is Bioverified by Oral Fluid|Self-reported abstinence (primary outcome) will be verified by oral fluid (OF) cannabis assessment. Oral fluid samples will be collected from participants who self-report prolonged abstinence.|6 month follow up||||Participants|||Count of Participants
2548747|NCT02869451|Primary|Number of Participants Who Self-report Prolonged Abstinence From Marijuana Use|Participants self-report marijuana use since marijuana quit date. Prolonged abstinence is defined as sustained abstinence since two weeks post-initial quit date.|6 month follow up||||Participants|||Count of Participants
2548748|NCT02869451|Primary|Number of Participants Who Report Smoking Abstinence and Abstinence is Bioverified by Salivary Cotinine|Self-reported abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence.|6 month follow up||||Participants|||Count of Participants
2548749|NCT02869451|Primary|Number of Participants Who Self-report Prolonged Abstinence From Smoking|Participants self-report smoking behavior since smoking quit date. Prolonged abstinence is defined as sustained abstinence since two weeks post-initial smoking quit date.|6 month follow up||||Participants|||Count of Participants
2560939|NCT02656836|Secondary|Proportion of Patients Able and Willing to Use the Tonometer|Proportion of patients willing to use the tonometer but are unable to. Patient feedback reported via questionnaire|Two weeks|||||||
2548750|NCT02869438|Other Pre-specified|Change From Baseline to End of Treatment in Airway Resistance (Raw) for Sub-study Patients|Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.|From first IP dose to Day 84|Body plethysmography sub-study analysis set|||kPa/L/sec||Standard Deviation|Mean
2548751|NCT02869438|Other Pre-specified|Change From Baseline to End of Treatment in Specific Airway Resistance (SGaw) for Sub-study Patients|Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.|From first IP dose to Day 84|Body plethysmography sub-study analysis set|||1/(kPa*sec)||Standard Deviation|Mean
2548752|NCT02869438|Other Pre-specified|Change From Baseline to End of Treatment in PGI-C|Patient global impression of change (PGI-C) is used for an overall evaluation of response to treatment. The patient is asked to rate the degree of change in overall asthma status compare to the start of treatment. A 7-point rating scale is used from 1=very much improved to 7=very much worse.|From first IP dose to Day 84|Full analysis set|||Participants|||Count of Participants
2548753|NCT02869438|Other Pre-specified|Change From Baseline to End of Treatment in CGI-C|Clinician global impression of change (CGI-C) is used for an overall evaluation of response to treatment. The investigator is asked to rate the degree of change in overall asthma status compare to the start of treatment. A 7-point rating scale is used from 1=very much improved to 7=very much worse.|From first IP dose to Day 84|Full analysis set|||Participants|||Count of Participants
2548754|NCT02869438|Other Pre-specified|Change From Baseline to End of Treatment in PGI-S|The patient global impression of severity (PGI-S) is a single item designed to capture the patient's perception of overall symptom severity at the time of the completion using a 6-point categorical response scale (no symptom [0] to very severe symptom [5])|From first IP dose to Day 84|Full analysis set|||Score on a scale||Standard Deviation|Mean
2548755|NCT02869438|Other Pre-specified|Anti-drug Antibody Responses|Anti-drug antibody responses at baseline and post baseline, including nAb responses|From first IP dose to end of treatment period (Day 84)|Safety analysis set|||Participants|||Count of Participants
2548756|NCT02869438|Other Pre-specified|PK Parameter of Benralizumab (Cmax)|PK parameters are derived in patients with at least three qualifiable serum PK concentrations post first dose (collected on Day 3, 7, and either 14, or 28)|First IP dose cycle (ie, data collected on Days 3, 7, 14 and 28)|PK analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2548757|NCT02869438|Other Pre-specified|Serum Concentration of Benralizumab|PK sample was collected pre-dose at each visit|From first dose to end of treatment period (Day 84)|PK analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2548758|NCT02869438|Secondary|Duration of IP Administration|Duration of IP administration is last IP dose date - first IP dose +1.|From first IP to last IP|Safety analysis set|||Days||Standard Deviation|Mean
2548759|NCT02869438|Secondary|Change From Baseline to End of Treatment in Vital Capacity (VC) for Sub-study Patients|Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.|From first IP dose to Day 84|Body plethysmography sub-study analysis set|||Liter||Standard Deviation|Mean
2548760|NCT02869438|Secondary|Change From Baseline to End of Treatment in Functional Residual Capacity (FRC) for Sub-study Patients|Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.|From first IP dose to Day 84|Body plethysmography sub-study analysis set|||Liter||Standard Deviation|Mean
2548761|NCT02869438|Secondary|Change From Baseline to End of Treatment in Inspiratory Capacity (IC) for Sub-study Patients|Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.|From first IP dose to Day 84|Body plethysmography sub-study analysis set|||Liter||Standard Deviation|Mean
2548762|NCT02869438|Secondary|Change From Baseline to End of Treatment in Ratio of Residual Volume (RV) and Total Lung Capacity (TLC) for Sub-study Patients|Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.|From first IP dose to Day 84|Body plethysmography sub-study analysis set|||ratio||Standard Deviation|Mean
2548763|NCT02869438|Secondary|Change From Baseline to End of Treatment in Total Lung Capacity (TLC) for Sub-study Patients|Lung volume subdivisions include total lung capacity (TLC), residual volume (RV), vital capacity (VC), functional residual capacity (FRC), and inspiratory capacity (IC), as well as airway resistance (Raw and SGaw) measurements.|From first IP dose to Day 84|Body plethysmography sub-study analysis set|||Liter||Standard Deviation|Mean
2548764|NCT02869438|Secondary|Change From Baseline to End of Treatment in FeNO|Airway inflammation was evaluated via fractional exhaled nitric oxide (FeNO) measurement.|From first IP dose to Day 84|Full analysis set|||ppb||Standard Deviation|Mean
2548765|NCT02869438|Secondary|Change From Baseline in St. George's Respiratory Questionnaire (SGRQ)|The SGRQ is designed to measure health impairment in patients with asthma and COPD. It contains two parts: Part 1 (Questions 1 to 8) covers the patients' recollection of their symptoms over a preceding 4 weeks; Part 2, 42 items, relates to the daily activity and psychosocial impacts of the individual's respiratory condition. Total score is presented as a percentage of overall impairment, in which 100 represents the worst possible health status, while 0 indicates the best.|From first IP dose to Day 84|Full analysis set|||Score on a scale||Standard Deviation|Mean
2548766|NCT02869438|Secondary|Change From Baseline in ACQ-6|ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.|From first IP dose to Day 84|Full analysis set|||Score on a scale||Standard Deviation|Mean
2548767|NCT02869438|Secondary|Percentage of Pre-BD FEV1 Responder|Pre-BD FEV1 responder is defined as change from baseline in FEV1 >=100 ml|From first IP dose to Day 84|Full analysis set|||Percentage of Participants|||Number
2548771|NCT02869438|Primary|Change From Baseline (Visit 4) to End of Treatment Day 84 (Visit 10) in Residual Volume (RV)|Body plethysmography was performed for sub-study patients. Lung volume subdivisions measures were performed by the investigator or qualified designee according to ATS/ERS guidelines.|From first IP dose to Day 84|Body plethysmography sub-study analysis set|||Liter||Standard Deviation|Mean
2548772|NCT02869438|Primary|Change From Baseline (Visit 4) to Day 28 (Visit 8), Day 56 (Visit 9), and Day 84 (Visit 10) in Pre-BD FEV1|The average over the mean differences between benralizumab and placebo for change from baseline in pre-BD FEV1 is used to determine if the study is positive and to determine maintenance of effect. The first post baseline time point where the p-value for the mean difference between benralizumab and placebo is less than or equal to 0.05 is used to determine time to onset of effect.|From first IP dose to Day 84|Full analysis set|||Liter||Standard Deviation|Mean
2548773|NCT02868892|Secondary|Overall Survival|Evaluate Overall survival for recurrent cervical adenocarcinomas treated with pemetrexed.|2 years|Investigator no longer at site. Study was closed with no PI transfer, data collection or statistical analysis.||||||
2548774|NCT02868892|Secondary|Response Rate|Evaluate the response rate for recurrent cervical adenocarcinomas treated with pemetrexed. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension which must have been 20 mm when measured by conventional techniques including palpation, plain X-ray, CT, and MRI or 10 mm when measured by spiral CT.|2 years|Investigator no longer at site. Study was closed with no PI transfer, data collection or statistical analysis.||||||
2548775|NCT02868892|Primary|Progression Free Survival|Evaluate the progression free survival of recurrent cervical adenocarcinoma. Progression-Free Survival is defined as the period of time from the date of first study drug administration to the date that the subject is determined to have progressive disease or death due to any cause.|2 years|Investigator no longer at site. Study was closed with no PI transfer, data collection or statistical analysis.||||||
2548776|NCT02868554|Secondary|Mean Patient Discomfort Score|Research subjects asked to complete questionaire at Week 12 in order to determine what effect vibratory stimulation has on discomfort during orthodontic treatment. The FACES Pain Visual Analog Pain Scale was used to assess pain. Pain was assessed on a 0 (no pain) to 10 (worst pain) grading scale. Lower scores reflect lower pain levels.|Week 12||||score on a scale||Standard Deviation|Mean
2548777|NCT02868554|Secondary|Activity of Bone Turnover Markers (BTMs) During Orthodontic Tooth Movement [Quantitative Polymerase Chain Reaction (qPCR), Cycle Threshold Values (Ct)]|Gingival crevicular fluid will be sampled to determine if vibratory stimulation during orthodontic tooth movement increases the activity of the Receptor Activator of Nuclear Factor-KappaB (RANK), Receptor Activator of Nuclear Factor-KappaB Ligand (RANKL) and Osteoprotegerin (OPG) cell signaling pathway.|12 weeks|Due to loss of key study personnel these data were not collected||||||
2548778|NCT02868554|Primary|Rate of Orthodontic Tooth Movement [Total % Change of Little's Irregularity Index]|The percent change in the irregularity index between the baseline and the final will be evaluated. Little's Irregularity Index is the sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine.|Baseline, 12 weeks||||percent change in LI||Standard Deviation|Mean
2548779|NCT02868554|Primary|Rate of Orthodontic Tooth Movement [Difference in Little's Irregularity Index, mm/Day]|The rate of orthodontic tooth movement (Little's Irregularity Index mm/day) will be evaluated. Little's Irregularity Index is the sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine.|Baseline, 12 weeks||||mm/day||Standard Deviation|Mean
2548780|NCT02868554|Primary|Little's Irregularity Index at Final Stage|Little's Irregularity Index is the sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine.|End of Study (a total of approximately 12 weeks)||||mm||Standard Deviation|Mean
2548781|NCT02868554|Primary|Little's Irregularity Index (LI) at Baseline|Little's Irregularity Index is the sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine.|Baseline (Week 0)||||mm||Standard Deviation|Mean
2548782|NCT02868242|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit"|Baseline to Posttreatment Week 24|Participants in Full Analysis Set were analyzed.|||percentage of participants|||Number
2548783|NCT02868242|Secondary|HCV RNA Change From Baseline/Day 1||Baseline; Weeks 1, 4, 8, and 12|Participants in the Full Analysis Set were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2548784|NCT02868242|Secondary|Percentage of Participants With HCV RNA < LLOQ While on Treatment||Weeks 1, 4, 8, and 12|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2548785|NCT02868242|Secondary|Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)|SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2548786|NCT02868242|Secondary|Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2548787|NCT02868242|Primary|Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event||First dose date up to Week 12|Safety Analysis Set included participants who took at least 1 dose of study drug.|||percentage of participants|||Number
2548788|NCT02868242|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 50 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set included participants who took at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2548789|NCT02868216|Primary|Difference in Flow-mediated Dilation in the Brachial Artery in the Base and After the Treatment.|"Inter group difference in flow-mediated dilation in the brachial artery in the baseline and after the treatment (about Three months after the first).~Vasodilatation of the endothelium-dependent brachial artery was evaluated by ultrasound using a 3-12 MHz linear transducer. Three images of the basal diameter (BD) of the brachial artery at the end of the diastole were acquired, as well as the mean velocity of the baseline arterial flow, with the linear transducer positioned 5 cm above the antecubital fossa. Subsequently, the sphygmomanometer was placed in the arm and inflated 50 mmHg above baseline systolic blood pressure for five minutes. After that, 3 images of the arterial diameter were acquired up to 80 seconds of the deflation of the cuff (post-occlusion diameter- PD), as well as the average of the arterial flow velocity. Flow-dependent vasodilation responses were expressed as a percentage variation from the baseline brachial diameter (PD-BD/ BD x 100)."|three months after the first evaluation|means and standard deviations after treatment|||percent change dilatation||Standard Deviation|Mean
2548790|NCT02867995|Secondary|Intent to Use Eye Drop Aid Long Term|A question on the six week survey asked if the participant intended to use the eye drop aid long term. Response options included: would use the drop aid long term, would not use the drop aid long term, or did not use a drop aid. Results were stratified by the three drop aid types (Fabrication Autodrop Eye Drop Guide, Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator).|6 weeks|Participants include all enrolled patients who completed the study. The drop aid group was stratified into the three types of aids- AutoDrop, Autosqueeze, and Simply Touch.|||Participants|||Count of Participants
2548791|NCT02867995|Secondary|Satisfaction With Eye Drop Aid|A question on the six week survey asked if the participant liked the eye drop aid. Response options included: liked the drop aid long term, did not like the drop aid, or did not use a drop aid. Results were stratified by the three drop aid types (Fabrication Autodrop Eye Drop Guide, Owen Mumford OP 6100 Autosqueeze, or the Simply Touch Eye Drop Applicator).|6 weeks|Participants include all enrolled patients who completed the study. The drop aid group was stratified into the three types of aids- AutoDrop, Autosqueeze, and Simply Touch.|||Participants|||Count of Participants
2548792|NCT02867995|Secondary|Number of Participants Stratified by the Number of Times Eye Was Missed When Inserting Eye Drops|A question on the six week survey asked approximately how often the participant missed their eye when inserting eye drops. Response options included: missed inserting eye drops 0 times, missed inserting eye drops 1 time, missed inserting eye drops 2 times, or missed inserting eye drops 3 or more times.|6 weeks|Participants include those who were compliant with their drop aid device throughout the length of their medication bottle, as well as those who were non-compliant with their device group.|||Participants|||Count of Participants
2548793|NCT02867995|Primary|Number of Participants Assessed for Intraocular Pressure Change|Intraocular pressure (IOP) is measured by Goldman applanation in patients and is expressed in mmHg. The IOP, which is a routine check in the ophthalmic exam, was measured in the eye drop aid group prior to starting drop aid use and at six weeks while using drop aids. IOP was measured at baseline and at 6 weeks in the control group. A significant increase in IOP is defined as an increase of 4 mmHg or more, a significant decreases in IOP is defined as a decrease of 4mmHg or more. No significant change in the IOP is a change between 1-3 mmHg.|baseline and 6 weeks||||Participants|||Count of Participants
2548794|NCT02867709|Secondary|Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose|Nausea was a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of nausea. Number analyzed is the number of participants with non-missing postdose nausea assessment at or before 2 hours after initial dose.|2 hours after initial dose|mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.|||percentage of participants|||Number
2548795|NCT02867709|Secondary|Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose|Phonophobia was defined as sensitivity to sound, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of phonophobia. Number analyzed is the number of participants with non-missing postdose phonophobia assessment at or before 2 hours after initial dose.|2 hours after initial dose|mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.|||percentage of participants|||Number
2548796|NCT02867709|Secondary|Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose|Photophobia was defined as sensitivity to light, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence photophobia. Number analyzed is the number of participants with non-missing postdose photophobia assessment at or before 2 hours after initial dose.|2 hours after initial dose|mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.|||percentage of participants|||Number
2548797|NCT02867709|Secondary|Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose|Sustained pain freedom was defined as a pain freedom at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a mild/moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with assessment of determinable sustained pain freedom from 2 to 24 hours after initial dose.|2 to 24 hours after initial dose|mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, determinable cases.|||percentage of participants|||Number
2548798|NCT02867709|Secondary|Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose|Sustained pain relief was defined as a pain relief at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with assessment of determinable sustained pain relief from 2 to 24 hours after initial dose.|2 to 24 hours after initial dose|mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, determinable cases.|||percentage of participants|||Number
2548799|NCT02867709|Secondary|Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose|Pain relief was defined as a reduction of a moderate/severe migraine headache to a mild headache or to no headache. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing pain severity assessment at or before 2 hours after initial dose.|Baseline (Predose) to 2 hours after initial dose|mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.|||percentage of participants|||Number
2548800|NCT02867709|Primary|Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose|The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'. Participants were provided with an eDiary to record absence or presence of migraine-associated symptoms. Number analyzed is the number of participants with non-missing postdose most bothersome migraine-associated symptoms assessed.|Baseline (Predose) to 2 hours after initial dose|mITT population included all randomized participants who received at least 1 dose of investigational product, recorded baseline migraine headache severity measurement, had ≥1 postdose migraine headache severity/migraine-associated symptom measurement at/before 2-hour timepoint, LOCF. Number analyzed is participants with data available for analysis.|||percentage of participants|||Number
2548801|NCT02867709|Primary|Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose|Pain freedom was defined as a reduction in headache pain severity from moderate/severe at baseline to no pain at 2 hours after the initial dose of investigational product. Participants were provided with electronic diary (eDiary) to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing postdose pain severity assessment at or before 2 hours after initial dose.|Baseline (Predose) to 2 hours after initial dose|Modified Intent-to-Treat (mITT) population included all randomized participants who received at least 1 dose of study drug, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, last observation carried forward (LOCF).|||percentage of participants|||Number
2548802|NCT02867202|Primary|the AFS Score at Second-look Hysteroscopy|The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.|2 or 3 months after the surgery||||Units on a scale||Full Range|Median
2548803|NCT02867163|Primary|Deep Vein Thrombosis|Incidence of deep vein thrombosis diagnosed by ultrasound scan on postoperative day 1|One day||||Participants|||Count of Participants
2548804|NCT02867150|Primary|Fat Reduction in Treatment Zone as Measured in Inches Lost|Circumferential measurement of thighs, hips and waist before and after treatment.|Single 32-minute treatment session||||inch||Full Range|Mean
2548805|NCT02867059|Primary|The Safety and Tolerability of SJ733 in Healthy Subjects (Men and WNCBP) Following Infection With Blood Stage P. Falciparum During the IBSM Challenge Study Will be Evaluated by Observation of Occurrence of Adverse Events|Number of participants with adverse events|for up to 25th day post SJ733 treatment or longer as determind by the principal investigator||||Participants|||Count of Participants
2548806|NCT02867059|Primary|Activity of SJ733 Administered Orally on Clearance of P. Falciparum Blood Stage Parasites From the Blood in Healthy Subjects (Men and WNCBP)|The PRR was estimated using the slope of the optimal fit of the log-linear relationship of the parasitaemia decay.|Until End of Study (Day 28±3)||||Parasite Reduction Rate (PRR)||95% Confidence Interval|Mean
2548807|NCT02866942|Secondary|Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Children Receiving LAIV|"Incidence of a 'significant exacerbation' in asthma, defined as:~i. At least 3 day course of oral steroids following an unscheduled contact with a healthcare professional; OR ii. Unscheduled visit to an Emergency department or admission to hospital for treatment of asthma symptoms, requiring systemic corticosteroids"|Up to 4 weeks post LAIV administration||||Participants|||Count of Participants
2548808|NCT02866942|Primary|Change in Asthma Symptoms and Control Pre and 4 Weeks Post LAIV, as Assessed by Validated Questionnaire|"The validated questionnaire to be used will depend on the age of the enrolled child:~Age 2-4 years: TRACK questionnaire~Age 5-11 years: Children's Asthma Control Test (C-ACT) score~Age 12+ years: Asthma Control Test (ACT) score~The change in score (using the appropriate questionnaire for age) between pre- and 4 weeks post LAIV will be used to assess the primary outcome across all participants. a change in (c-)ACT of at least 3 points, or 10 points for TRACK will be determined a significant change.~For TRACK, the minimum and maximum score possible is 0 and 100 respectively, the higher the score, the better is symptom control.~For c-ACT, the minimum and maximum score possible is 0 and 27 respectively, the higher the score, the better controlled are asthma symptoms.~For ACT, the minimum and maximum score possible is 5 and 25 respectively, the higher the score, the better controlled are asthma symptoms."|4 weeks post LAIV|4 week follow-up data available in 319/478 participants|||Participants|||Count of Participants
2549024|NCT02862106|Secondary|Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales;||week95,108,120,144|intent to treat population|||percentage of participants|||Number
2548809|NCT02866695|Secondary|Participant's Local Skin Response Grading Scale|To investigate the local skin response to ingenol mebutate in organ transplant recipients. Local skin reaction (LSR) will be graded by visual assessment on a 4 point scale where 0=none, 1=mild, 2=moderate, 3=severe. Each of the following four reactions will be graded: erythema, vesiculation/postulation, crusting/scabbing/erosion, and edema/swelling. A composite score will be calculated (range 0-16). A high LSR indicated a worse outcome. LSR assessment will be performed at days 1, 8, 29, and 84.|Day 1, Day 4 (assessed at screening, day 1, day 4, day 29, day 57, and study early termination if applicable, results at day 1 and day 4 reported)||||score on a scale||Standard Deviation|Mean
2548810|NCT02866695|Secondary|Number of Participants With a Reduction of Actinic Keratosis|To evaluate the efficacy of ingenol mebutate for reduction of actinic keratoses on the face in organ transplant recipients.|Day 57 (assessed at screening, day 1, day 29, day 57, and study early termination if applicable, clearance at day 57 reported)||||Participants|||Count of Participants
2548811|NCT02866695|Primary|Number of Participants With Adverse Events|To evaluate the safety of ingenol mebutate gel 0.015% on the face in solid organ transplant recipients|From screening to Day 57 or study early termination if applicable||||Participants|||Count of Participants
2548812|NCT02865720|Primary|Time From Treatment With CINRYZE to Initial Improvement|Time to initial improvement was calculated from the time of study drug administration to initial symptom improvement. Median time from treatment with CINRYZE to initial improvement was reported.|Baseline up to Week 12|FAS included all participants who had at least 1 post-baseline efficacy assessment.|||Hours||95% Confidence Interval|Median
2548813|NCT02865720|Primary|Time From Onset of Attack to Time Treated by CINRYZE|The median time from onset of attack to time treated with CINRYZE was reported.|Baseline up to Week 12|FAS included all participants who had at least 1 postbaseline efficacy assessment.|||Hours||95% Confidence Interval|Median
2548814|NCT02865720|Primary|Time From Attack Onset to Initial Improvement and Complete Resolution|Time to initial improvement (TII) was calculated from the time of study drug administration to initial symptom improvement. Time to complete resolution was defined as the time from the onset of attack to complete resolution of all symptoms. Time to initial improvement and time to complete resolution as assessed by CINRYZE, non-CINRYZE and untreated were reported.|Baseline up to Week 12|FAS included all participants who had at least 1 post-baseline efficacy assessment. Number of participants evaluable for this outcome were reported.|||Hours||95% Confidence Interval|Median
2548815|NCT02865720|Primary|Number of Participants With Breakthrough Angioedema Attacks|A breakthrough attack was defined as an angioedema attack that occurs during long-term prevention therapy with CINRYZE (that is, between first study drug and last study drug dose). Number of participants with 1, 2, 3 or more angioedema attacks and who achieved initial improvement and complete resolution were also reported. Breakthrough angioedema attacks assessed by CINRYZE treatment, non-CINRYZE C1 INH treatment and untreated with C1-INH were reported. Here BAA refers to breakthrough angioedema attacks.|Baseline up to Week 12|FAS included all participants who had at least 1 post-baseline efficacy assessment. Number of participants evaluable for this outcome measure was reported.|||Participants|||Count of Participants
2548816|NCT02865720|Primary|Change From Baseline in Angioedema Quality of Life (AE-QoL) in Treatment Period|Angioedema quality of life (AE-QoL) questionnaire was a self-administered validated angioedema disease-specific quality of life instrument. It consisted of 17 specific questions that were associated with work, physical activity, free time, social relations, and diet. Each of the 17 items had a 5-point response scale ranging from 1 (Never) to 5 (Very Often). The questionnaire was scored according to the developers' guidelines to produce a total score and 4 domain scores (functioning, fatigue/mood, fear/shame, nutrition). Raw domain scores (mean of the item scores within each scale) and the raw total score (mean of all item scores) were rescaled using linear transformations into final percentage scores ranging 0 to 100, based on the maximum possible score, where the higher the score the greater the QoL impairment.|Baseline, Week 12|FAS included all participants who had at least 1 post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2548817|NCT02865720|Primary|Number of Participants Achieving Clinical Responder Rate Relative to Historical Data|Number of participants achieving at least 50 percent (%), 70% or 90% reduction in NNA relative to NNA for historical data was reported.|Baseline up to Week 12|FAS included all participants who had at least 1 post-baseline efficacy assessment.|||Participants|||Count of Participants
2548818|NCT02865720|Primary|Normalized Number of Angioedema Attacks (NNA) Per Month Treated With Rescue Medication|"The normalized number of angioedema attacks was calculated as the overall number of angioedema attacks recorded during the period divided by the number of days in the period and multiplied by 30.4. NNA treated with rescue medications were reported for CINRYZE, non-CINRYZE C1-INH or not treated with C1-INH (including attacks treated with any medications other than C1-INH or untreated attacks). CINRYZE was only considered as a rescue medication when treated for breakthrough attack treatment. For historical data, only medications taken prior to the start of drug study drug administration and had an indication of hereditary angioedema (HAE) management - acute treatment selected on the prior and concomitant medications and therapy were considered as rescue medications. Historical data was obtained from medical or angioedema history eCRF."|Baseline up to Week 12|FAS included all participants who had at least 1 post-baseline efficacy assessment.|||Angioedema attacks per month||Standard Deviation|Mean
2548819|NCT02865720|Primary|Average Duration of Angioedema Attacks|Average duration of attacks was calculated by dividing the cumulative duration of attacks by the total number of attacks during the treatment period. Historical data was based on the typical severity of angioedema attacks in the 3 months prior to study drug administration. Average duration of angioedema attacks in treatment period was compared to the NNA for historical data. Historical data was obtained from medical or angioedema history eCRF.|Baseline up to Week 12|FAS included all participants who had at least 1 post-baseline efficacy assessment.|||Days||Standard Deviation|Mean
2548871|NCT02864069|Primary|Rivermead Behavioral Memory Test|The Rivermead Behavioral Memory Test (RBMT) is an ecologically valid assessment of cognitive functioning that tests some skills specifically trained in the CT condition (e.g., name learning, and story learning) but also additional untrained skills such as prospective memory. Belongings subtest scaled scores: Minimum score = 1, Maximum score = 19; higher values represent better performance.|12 weeks||||units on a scale||Standard Deviation|Mean
2549025|NCT02862106|Secondary|Change From Baseline by Visit for Serum HBV DNA||week95,108,120,144|intention to treat population|||log_10 IU/mL||Standard Deviation|Mean
2548820|NCT02865720|Primary|Average Severity (Intensity) of Angioedema Attacks|All attacks in each therapy period were assigned a value of 1 (mild), 2 (moderate), or 3 (severe). Attack severity was considered the highest value assigned by the participant to any swelling location on any day during the attack. The average severity was derived by dividing the cumulative severity score by the total number of attacks. Average severity was set to 0 if there was no attack in a period. Average severity of angioedema attacks in treatment period compared to the NNA of angioedema attacks for historical data was reported. Historical data was based on the typical severity of angioedema attacks in the 3 months prior to study drug administration. Historical data was obtained from medical or angioedema history electronic case report forms (eCRF).|Baseline up to Week 12|FAS included all participants who had at least 1 postbaseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2548821|NCT02865720|Primary|Number of Participants With Angioedema Attacks in Different Anatomic Locations|Anatomic locations where there was a presence of pain or swelling of any level of severity; mild, moderate or severe at any day during the attack were reported. Mild: the attack symptoms were noticeable but were easily tolerated by the participant and did not interfere with the participant's daily activities. Moderate: the attack symptoms interfered with the participant's ability to attend work/school or participate in family life and social/recreational activities and severe: the attack symptoms significantly limited the participant's ability to attend work/school or participate in family life and social/recreational activities. Number of participants with angioedema attacks in different anatomic locations in treatment period was compared to NNA for historical data. Historical data was based on the typical location of angioedema attacks in the 3 months prior to study drug administration. Here, H refers to historical and T refers to treatment.|Baseline up to Week 12|FAS included all participants who had at least 1 post-baseline efficacy assessment.|||Participants|||Count of Participants
2548822|NCT02865720|Primary|Normalized Number of Angioedema Attacks (NNA) Per Month|Angioedema attack was defined as any participant-reported (or caregiver-reported) indication of swelling or pain at any location following a report of no swelling or pain on the previous day (that is, there must have been a full symptom-free calendar day preceding the onset of symptoms for an attack to be considered a new attack). NNA was calculated as the overall number of angioedema attacks recorded during the period divided by the number of days in the period and multiplied by 30.4.Number of attacks was normalized for the number of days participants participated in a given period and expressed as the monthly frequency as compared to the historical data where, NNA was the number of angioedema attacks during 3 months prior to study drug administration. Historical data was obtained from medical or angioedema history electronic case report forms (eCRF).|Baseline up to Week 12|Full analysis set (FAS) included all participants who had at least 1 post-baseline efficacy assessment.|||Angioedema attacks per month||Standard Deviation|Mean
2548823|NCT02865720|Primary|Concentration of Plasma Complement C1q at Week 1|Concentration of plasma complement C1q was reported.|Baseline (Week 1)|PD set included all participants with evaluable PD profiles.|||International units per milliliter||Standard Deviation|Mean
2548824|NCT02865720|Primary|Concentration of Plasma Complement C4 at Week 12|Concentration of plasma complement C4 was reported.|Week 12: Pre-dose, 0.5, 1, 2, 6, 24, 48, 72 and 96 h post-dose|PD set included all participants with evaluable PD profiles.|||mg/L||Standard Deviation|Mean
2548825|NCT02865720|Primary|Concentration of Plasma Complement C4 at Week 1|Concentration of plasma complement C4 was reported.|Week 1: Pre-dose, 0.5, 1, 2, 6, 24, 48, 72 and 96 h post-dose|Pharmacodynamic (PD) set included all participants with evaluable PD profiles.|||Milligram per liter (mg/L)||Standard Deviation|Mean
2548826|NCT02865720|Primary|Concentration of C1 Esterase Inhibitor (C1 INH) Antigen (Protein Volume) at Week 12|C1 INH antigen concentration in plasma was determined using an automated nephelometric assay.|Week 12: Pre-dose, 0.5, 1, 2, 6, 24, 48, 72 and 96 h post-dose|PK set included all participants with evaluable PK profiles.|||gram per liter (g/L)||Standard Deviation|Mean
2548827|NCT02865720|Primary|Concentration of C1 Esterase Inhibitor (C1 INH) Antigen (Protein Volume) at Week 1|C1 INH antigen concentration in plasma was determined using an automated nephelometric assay.|Week 1: Pre-dose, 0.5, 1, 2, 6, 24, 48, 72 and 96 hours (h) post-dose|Pharmacokinetic (PK) set included all participants with evaluable PK profiles.|||Gram per liter (g/L)||Standard Deviation|Mean
2548828|NCT02865720|Primary|Number of Participants With Potentially Clinically Important (PCI) Clinical Laboratory Assessments Reported as Adverse Events (AEs)|Number of participants with potentially clinically important (PCI) clinical laboratory assessments reported as adverse events were reported.|Baseline up to Week 12|ITT-S set included participants who received any amount of investigational product.|||Participants|||Count of Participants
2548829|NCT02865720|Primary|Number of Participants With Potentially Clinically Important (PCI) Vital Signs Reported as Adverse Events (AEs)|Vital sign assessments included systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate. Investigator used both absolute values and change from baseline values to determine if the vital sign was potentially clinically important. Criteria for the potential clinical importance of both absolute and change from baseline values were pre-specified as: SBP (less than [<] 90 millimeter of mercury [mmHg]; greater than or equal to [>=] 140 mmHg), DBP (< 60 mmHg; >=90 mmHg) and pulse (less than or equal to [<=] 50 beats per minute [bpm]; >= 100 bpm. A participant's vital sign had to meet both the absolute and change from baseline criteria to be considered as potentially clinically important.|Baseline up to Week 12|ITT-S set included participants who received any amount of investigational product.|||Participants|||Count of Participants
2548830|NCT02865720|Primary|Number of Participants With Clinically Significant Abnormalities in Physical Examination Reported as Adverse Events (AEs)|Physical examinations included measurement of body weight and height. Clinically significant abnormalities related to physical examination as determined by investigator were recorded and reported as AE.|From start of study drug administration up to Week 12|ITT-S set included participants who received any amount of investigational product.|||Participants|||Count of Participants
2548872|NCT02863575|Other Pre-specified|Number of Participants Who Used Medications Prior to This Study|In this outcome measure number of participants who were using any type of medications, prior to start of the study were reported.|At Screening|Safety analysis population included all participants who received the study medication.|||Participants|||Count of Participants
2549026|NCT02862106|Secondary|The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit||week95,108,120,144|intention to treat population|||percentage of participants|||Number
2548831|NCT02865720|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational product and that did not necessarily have a causal relationship with the treatment. TEAEs were defined as all AEs that started during the treatment period and up to 7 days after the last dose of investigational product, or AEs that were seen at baseline but worsened in frequency and/or severity during the treatment period and up to 7 days after the last dose of investigational product.|From start of study drug administration up to Week 12|ITT-S set included participants who received any amount of investigational product.|||Participants|||Count of Participants
2548832|NCT02865590|Primary|Histomorphometric Evaluation of New Bone Formation.||6 months|Caucasion patients aged ≥ 25 years with at least one atrophic posterior maxilla (distally from first bicuspid teeth) with a residual crest height ≤4 mm who need sinus lift augmentation for dental implant placement were eligible for the study.|||percentage of millimeters||Standard Deviation|Mean
2548833|NCT02865499|Primary|Change in Microbiome|Changes in bacterial community measurement through DNA extraction from stool samples. Change is measured using operational taxonomic units (OTU). An OTU is the group of organisms being studied through DNA to cluster sequences of microbiomes according to their similarity to one another (the similarity threshold is set to 97%). This outcome measures change in the number of OTUs from baseline to 12 weeks.|Baseline; 8 weeks and 12 weeks||||Operational Taxonomic Unit (OTU)|||Number
2548834|NCT02865395|Secondary|Post-Operative Pain|Patients will be asked to fill out a short questionnaire with the faces scale to grade their pain on a scale of 1-10|24 hours|Data was not collected on these patients.||||||
2548835|NCT02865395|Primary|Post-operative Morphine Equivalent Dose|No results collected on the post-operative morphine equivalent dose|24 hours|Study terminated prior to results.||||||
2548836|NCT02865083|Secondary|Need for Hospital Readmission or Emergency Room Visits|To determine if there is a difference in need for hospital readmission or emergency room visits between the treatment group and the control/standard group.|6 weeks|Data were not collected.||||||
2548837|NCT02865083|Secondary|Other Complication Rate|To determine if there is a difference in other complication rates between the treatment group and the control/standard group.|6 weeks|Data were not collected.||||||
2548838|NCT02865083|Secondary|Postoperative Length of Stay|To determine if there is a difference in postoperative length of stay between the treatment group and the control/standard group.|3-4 days|Data were not collected.||||||
2548839|NCT02865083|Secondary|Estimated Blood Loss|To determine if there is a difference in estimated blood loss between the treatment group and the control/standard group.|At time of surgery|Data were not collected.||||||
2548840|NCT02865083|Secondary|Change in Hemoglobin|To determine if there is a difference in change in hemoglobin between the control/standard group and the treatment group.|24 hours after surgery|Data were not collected||||||
2548841|NCT02865083|Secondary|Duration of Surgery or Length of Time From Skin Incision to Delivery of the Infant|To determine if there is a difference in duration of surgery or length of time from skin incision to delivery of the infant between the treatment group and the control/standard group.|At time of surgery|Data were not collected.||||||
2548842|NCT02865083|Primary|Wound Disruption Rates|To determine if there is a difference in wound disruption rates, in obese patients who have Cesarean sections when the Traxi retractor is used during Cesarean sections, when compared to traditional pannus retractor techniques, montogmery straps.|24 hours from placement of device|Patient data not collected||||||
2548843|NCT02864732|Secondary|Patient Satisfaction Survey|"Satisfaction level with the interventions. Subjects were asked rate their satisfaction with the treatment by choosing one of the following statements:~Very satisfied Satisfied Neutral Unsatisfied Very unsatisfied"|only post-treatment at 6 weeks||||Participants|||Count of Participants
2548844|NCT02864732|Secondary|Paraspinal Muscle Strength|"The paraspinal muscle strength was assessed using the Biodex 3 Pro dynamometer (20 Ramsey Rd, Shirley, NY 11967). Active extension of the trunk was performed with the subject in a semi-standing position; the subject's hips were flexed at 60 degrees with the feet resting on an adjustable footrest. The thighs were secured to the seat with two Velcro straps. The scapulae rested against a roll that is attached to the chair arms. The trunk was secured with two Velcro straps that crossed the front trunk forming the shape of an X. The subject was asked to extend the trunk by exerting maximal isometric contraction for 5 seconds against the scapular roll. The average of three 5-second trials was recorded. All subjects received the same verbal instruction: Push your trunk against the scapular roll as strong as you can. The higher the score the stronger the muscles. The range starts from 0 without a limit to the amount of force that could be exerted."|Baseline - 6 weeks (post-treatment)||||Nm||Standard Deviation|Mean
2548845|NCT02864732|Secondary|Fear-avoidance Behavior Questionnaire|The Fear-avoidance Behavior Questionnaire (FABQ) measure avoidant behavior to physical activity or work due to fear of pain. The has two sub scales: physical activity and work. This FABQ consists of 16 items; 5 items for the physical activity sub scale and 11 items for the work subscale. Each item is scored from 0-6. Higher scores on the FABQ are indicative of greater fear and avoidance beliefs. The total score on the FABQ is 66, however, this score is considered separately. The FABQ-physical activity sub scale ranges from 0 - 24 points and the FABQ-work activity ranges from 0 - 42 points.|Baseline to 6 weeks (post-treatment)||||units on a scale||Standard Deviation|Mean
2548846|NCT02864732|Secondary|Numeric Pain Rating Scale (NPRS)|The NPRS measures pain intensity on an 11-point scale from 0 (no pain) to 10 (maximum pain). The higher the score the worst the pain intensity|Baseline to 6 weeks (post-treatment) to 10 weeks (follow-up)||||units on a scale||Standard Deviation|Mean
2548847|NCT02864732|Primary|Modified Oswestry Disability Questionnaire (MODQ)|The MODQ is a self-reported measure of disability consisting of 10 domains of functional activities related to low back pain. The domains include pain intensity, personal care, lifting, walking, standing, sitting, traveling, social life, employment/homemaking, and sleeping. Each domain is rated from 0 - 5. The total of all the domains range from 0 - 50. The scores can be multiplied by 2 to get a percentage of functional disability. The higher the percentage the higher the disability.|Baseline to 6 weeks (post-treatment) to 10 weeks (follow up).||||percentage of functional disability||Standard Deviation|Mean
2549027|NCT02862106|Secondary|The Proportion of Patients With Both Negative HBsAg and HBsAb.||week95,108,120,144|intent-to-treat population|||percentage of participants|||Number
2548848|NCT02864732|Primary|Tolerability of Electrical Stimulation (NMES)|"NMES tolerability was performed by asking each subject in the stab + NMES group to describe their subjective perception of both the intensity and discomfort of the NMES current using the descriptors listed in a table. The descriptors represent two distinct domains of adjectives: the sensory aspect of the perceived intensity of stimulation and the affective aspect of the perceived discomfort. Each aspect has 15 adjectives. Each subject was asked to describe the current using the descriptors listed for each aspect at baseline and at 6 weeks.~To analyze the the subjects description of the current, the 15 descriptors of each aspect were divided into 3 zones (high, medium, low). The top 5 descriptors in each aspect were considered high, the middle 5 descriptors were considered medium, and the bottom descriptors were considered low.~Descriptive statistics were used to compare the subjects description of each aspect at baseline and at 6 weeks follow-up."|Participants were followed from baseline to 6 weeks|This outcome measure was only used with the Stabilization plus Electrical Stimulation|||Participants|||Count of Participants
2548849|NCT02864706|Secondary|Number of Participants With Beck Depression Inventory (BDI)|Beck Depression Inventory (BDI) Score has the following categories of depression. Normal, Mild, Moderate Severe and Missing.|at the 5-7 year visit|ITT|||Participants|||Count of Participants
2548850|NCT02864706|Secondary|Change From Baseline in Visual Analog Scale (VAS)|"Change in visual analog scale (VAS) from baseline to the 5 to 7 Year follow up visit.~0 is no pain; and 10 is the worst possible pain"|baseline, at the 5-7 year visit|Intent to treat|||mm||Standard Deviation|Mean
2548851|NCT02864706|Secondary|Change From Baseline in the Euro Quality of Life 5D|"Change from baseline in Euro Quality of Life-5D from 3 Year Follow-Up to 5 to 7 Year Follow-Up Baseline Visit 1 (ITT Set)~Euro Quality of Life 5D (EQ-5D): is a descriptive system of healthrelated quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) each of which can be assessed as one of three levels of severity (no problems/some or moderate problems/extreme problems). A Visual Analogue Scale (VAS)-scale is also included in the EQ-5D questionnaire.~The EQ-5D index is calculated based on the United Kingdom Time Trade-Off (TTO) N3 value set which converts the five dimensions scores into a single measure with a possible range from -0.163 (worst possible health state) to +1 (perfect health). A positive change from baseline indicates an improvement in Quality of Life."|Baseline, 5-7 year visit|intent to treat|||scores on the scale||Standard Deviation|Mean
2548852|NCT02864706|Secondary|Quality of Life by SF-36 Change From Pre-transplantation to 5-7 Year Follow-up|This Quality of life Short Form Survey with 36 items (Minnesota Living with Heart Failure Questionnaire)was administered to patients pre-transplantation and after transplantation at the 5-7 year visit. This data represents the change. The survey consist of scores on a scale. Each form is scaled from 0 t 100. 0 = maximum disability and 100 equals no disability.|at the 5-7 year visit|intent to treat|||scores on a scale||Standard Deviation|Mean
2548853|NCT02864706|Secondary|Myocardial Structure and Function|Myocardial structure and function by echocardiography assessment measured by ventricular end systolic diameter.|within 5-7 years|intent to treat|||cm||Standard Deviation|Mean
2548854|NCT02864706|Secondary|Percent of Participants With Incidence of Coronary Allograft Vasculopathy (CAV)|"Cardiac Allograft Vasculopathy (CAV) was defined as mean maximal intimal thickness (MIT)~≥0.5 mm, measured for the entire matched pullback recording by intravascular ultrasound (IVUS). The incidence of CAV at 5-7 years was compared between groups using the Cochran-Mantel-Haenszel test with stratification according to baseline distribution of CAV incidence."|at the 5-7 year follow-up|Intent to Treat|||percent of participants|||Number
2548855|NCT02864706|Secondary|Progression of Cardiac Allograft Vasculopathy (CAV) Recorded by Intravascular Ultrasound (IVUS)|"Cardiac Allograft Vasculopathy (CAV) was defined as mean maximal intimal thickness (MIT)~≥0.5 mm, measured for the entire matched pullback recording by intravascular ultrasound (IVUS). The incidence of CAV at 5-7 years was compared between groups using the Cochran-Mantel-Haenszel test with stratification according to baseline distribution of CAV incidence."|within 5-7 years|Intent to Treat.|||mm||Standard Deviation|Mean
2548856|NCT02864706|Primary|Measured Glomerular Filtration Rate (mGFR)|Renal function as assessed by measured Glomerular Filtration Rate (mGFR) (Cr-EDTA or iohexol clearance). Baseline Visit 1 and Patient 4252 excluded from the intent treat analysis set.|at the 5-7 year follow-up visit|intent to treat. 1 patient was excluded from ITT due to missing mGFR.|||mL/min/1.73m2||Standard Deviation|Least Squares Mean
2548857|NCT02864342|Secondary|Mean Number of Symbicort Prescription Refills at Pharmacy Over the 26-Week Study Period.|The total number of Symbicort prescriptions filled at a pharmacy during the 26-week treatment period was counted per subject. The mean number of Symbicort 30-day prescription refills per subject was then calculated and presented per group.|From baseline to EOT (6 months).|The FAS consisted of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study. Only subjects with data available for analysis are presented.|||Number of Refills||Standard Deviation|Mean
2548858|NCT02864342|Secondary|Mean Number of Adherent Days Over the 26-Week Study Period.|The total number of adherent days was defined as the number of treatment days a subject took 2 sets of 2 puffs of Symbicort and the inhalations in a puff set were within 60 minutes of each other. Subjects who did not take exactly 2 sets of 2 puffs on any given day throughout their device time on study were considered non-adherent for that day. The total number of adherent days for each subject was counted over the 26 week treatment period and the mean number of adherent days per group is presented.|From baseline to EOT (6 months).|The FAS consists of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study.|||Days||Standard Deviation|Mean
2548859|NCT02864342|Secondary|Mean Number of Adherent Sets of Puffs Per Day for Each 2-Month Study Interval.|The mean number of adherent sets of Symbicort puffs per day was calculated for each subject, for each of the 3, 2-month study intervals. Interval 1: from study day 1 to study day 63 (inclusive); Interval 2: study day 64 to study day 126 (inclusive); Interval 3: study day 127 to EOT (inclusive). A set is 2 puffs taken on the same calendar day, with the 2 puffs taken within 60 minutes of each other. The mean number of sets of Symbicort puffs per day was determined only for the days during device time on study for each subject.|From baseline to EOT (6 months).|The FAS consisted of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study. Only subjects with data available for analysis are presented.|||Adherent sets of puffs / day||Standard Deviation|Mean
2548860|NCT02864342|Secondary|Mean Total and Domain Weekly CCQ Scores Over Each 2-Month Study Interval for the Intervention Group.|The CCQ is a 10-item measure of a subject's COPD symptoms, divided into 3 domains (Symptoms: Items 1, 2, 5 and 6; Functional State: Items 7, 8, 9, and 10; and Mental State: Items 3 and 4). Individual items within the CCQ were equally weighted. The total score was calculated by adding the scores of the 10 items and dividing that number by 10 (=number of items). Individual domain scores were also calculated. The total CCQ score and each of the 3 domain scores range from 0 (very good health status) to 6 (extremely poor health status). Subjects in the intervention group took the CCQ weekly throughout the study. The 26-week treatment period was broken down into 3, 2-month intervals: Interval 1: from study day 1 to study day 63 (inclusive), Interval 2: study day 64 to study day 126 (inclusive), Interval 3: study day 127 to EOT (inclusive). The last week of each 2-month interval was used to represent that interval and results are presented for the total CCQ score and the 3 domain scores.|From baseline to EOT (6 months).|The FAS consisted of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study. Only subjects with CCQ results available for analysis are presented.|||Units on the CCQ scale.||Standard Deviation|Mean
2548861|NCT02864342|Secondary|Mean Clinical COPD Questionnaire (CCQ) Scores at Baseline, EOT, and Mean Change in Score Over the 26-Week Study Period.|The CCQ is a 10-item measure of a subject's COPD symptoms, divided into 3 domains (Symptoms: Items 1, 2, 5 and 6; Functional State: Items 7, 8, 9, and 10; and Mental State: Items 3 and 4). Individual items within the CCQ were equally weighted. The total score was calculated by adding the scores of the 10 items and dividing that number by 10 (=number of items). In addition, individual domain scores were calculated. The total CCQ score and each of the 3 domain scores range from 0 (very good health status) to 6 (extremely poor health status). CCQ data was collected for all subjects at baseline and EOT visits. The mean CCQ total and domain scores at both baseline and 26 weeks (EOT) are presented along with the mean change from baseline at EOT or week 26. A positive change indicates worsening symptoms and a higher value is indicative of a poorer health status.|From baseline to EOT (6 months).|The FAS consisted of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study. Only subjects with CCQ results available for analysis are presented.|||Units on the CCQ scale||Standard Deviation|Mean
2548862|NCT02864342|Primary|Mean Number of Adherent Sets of Symbicort Puffs Per Day Over the 26-Week Study Period|The mean number of adherent sets of Symbicort puffs per day for each group, over an average of 26 weeks was calculated. An adherent set of puffs was defined as exactly 2 sets of 2 Symbicort puffs per day. The 2 puffs that constitute a set must have been taken within 60 minutes of each other. A mean of 2.00 sets would be equal to 100% adherence (2 sets of 2 puffs). Subjects who did not take exactly 2 sets of 2 puffs on any given day throughout their device time on study were considered non-adherent for that day.|From baseline to end of treatment (EOT), (6 months).|The FAS consisted of screened subjects who were randomized and took at least 1 inhalation of Symbicort during the treatment phase of the study.|||Adherent sets of puffs / day||Standard Deviation|Mean
2548863|NCT02864316|Secondary|Overall Survival|Overall survival was planned to be measured at 5 years post-intervention as the time from enrollment until death. Instead, due to early termination for low accrual, the number of participants alive at the time of study termination is reported.|Up to 22 months||||Participants|||Count of Participants
2548864|NCT02864316|Secondary|Number of Participants With Treatment-related Adverse Events|Number of participants with treatment-related adverse events as defined by CTCAE 4.0 criteria.|up to 100 days post-intervention||||Participants|||Count of Participants
2548865|NCT02864316|Secondary|Duration of Response|The duration of overall response is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, accessed up to 3 years.|Up to 22 months|Data was not collected to assess this outcome measure since none of the participants experienced a response.||||||
2548866|NCT02864316|Secondary|Progression-free Survival|Number of participants alive without progression.|Up to 22 months|Data was not collected for 1/2 participants from the non-sarcoma arm since the participant was discontinued from therapy (due to adverse event) before disease re-evaluation for response could be performed.|||Participants|||Count of Participants
2548867|NCT02864316|Secondary|Percentage of Patients Progression-free at 24 Weeks From the Time of Enrollment|Disease status at 24 weeks will be compared to disease status at the time of enrollment, and response coded based on RECIST 1.1 criteria.|24 weeks|Data was not collected to assess this outcome measure since no participants remained on the study at 24 weeks.||||||
2548868|NCT02864316|Primary|Best Objective Response Rate|Number of participants with response. Response will be assessed at baseline (within 4 weeks prior to starting nivolumab) and then every 8 weeks while on Nivolumab, up to 24 weeks. The best objective response will be assessed at 24 weeks. Response will be defined based on RECIST 1.1 criteria where complete response (CR)= disappearance of all target lesions, partial response (PR) is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.|Up to 24 weeks|Data was not collected for 1/2 participants from the non-sarcoma arm since the participant was discontinued from therapy (due to adverse event) before disease re-evaluation for response could be performed.|||Participants|||Count of Participants
2548869|NCT02864069|Primary|Older Peoples Quality of Life Questionnaire|Self report assessment of quality of life specific to older adults. Assessment covers life overall, health, social relationships and participation, independence, control over life and freedom, home and neighborhood, psychological and emotional well-being, financial circumstances, leisure/activities, and culture and religion. Total score minimum = 35, max = 175; lower scores indicate better quality of life.|12 weeks||||units on a scale||Standard Deviation|Mean
2548870|NCT02864069|Primary|Everyday Cognition Scale|The Everyday Cognition Scale (ECog) assesses (via informant report) everyday cognitive functioning in memory, language, visuospatial, and executive functioning domains. Average total score was used: Minimum = 1, Maximum = 4, higher scores indicate greater impairment|12 weeks||||units on a scale||Standard Deviation|Mean
2549028|NCT02862106|Secondary|The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144||week95,108,120,144|intention to treat population|||percentage of participants|||Number
2549029|NCT02862106|Secondary|The Proportion of Patients With Both Negative HBeAg and HBeAb.||week95,108,120,144|intention to treat population|||percentage of paricipants|||Number
2548873|NCT02863575|Other Pre-specified|Number of Participants Who Used Concomitant Medications, and Rescue Medications|Rescue medication: participants who did not experience adequate relief after the 1 hour (post study drug dose) evaluation were given tramadol hydrochloride 50 to 100 mg orally or codeine sulfate 15 to 60 mg orally, based on the discretion of the Investigator, as rescue medication. If needed, 2 additional doses of rescue medications based on the discretion of the Investigator at the study center was given. Total maximum dose of tramadol was 300 mg and of codeine sulfate was 180 mg. Concomitant medication: medication received by participant other than study medication and rescue medication.|Day 1|Safety analysis population included all participants who received the study medication.|||Participants|||Count of Participants
2548874|NCT02863575|Other Pre-specified|Number of Participants With Clinically Significant Vital Signs Abnormalities|Vital signs included: heart rate, blood pressure, respiratory rate, and temperature. Normal range for the vital signs were: systolic blood pressure 90 to 140 millimeter of mercury (mmHg), diastolic blood pressure 60 to 90 mmHg, heart rate 50 to 110 beats per minute, respiratory rate 12 to 22 breaths per minute, and oral temperature 97.0 to 99.6 Fahrenheit (F). Value for vital signs outside the normal range was consider as abnormal. Clinical significance of vital signs abnormalities was determined at the investigator's discretion.|Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days)|Safety analysis population included all participants who received the study medication.|||Participants|||Count of Participants
2548875|NCT02863575|Other Pre-specified|Number of Participants With Treatment Emergent Treatment Related Adverse Events (AEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pre-treatment state. Relatedness of an AE to study drug was assessed by investigator.|Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days)|Safety analysis population included all participants who received the study medication. Here, “Overall Number of Participants Analyzed” were those participants who had at least 1 treatment emergent AEs.|||Participants|||Count of Participants
2548876|NCT02863575|Other Pre-specified|Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pre-treatment state. AEs are classified according to severity in 3 categories as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function).|Screening up to Day 17 after the last dose of study drug (approximately maximum of 48 days)|Safety analysis population included all participants who received the study medication. Here, “Overall Number of Participants Analyzed” were those participants who had at least 1 treatment emergent AEs.|||Participants|||Count of Participants
2548877|NCT02863575|Secondary|Time to Treatment Failure|Treatment failure was defined as time to first dose of rescue medication or study discontinuation of the participants due to lack of efficacy.|Up to 8 hours post dose on Day 1|FAS population included all randomized participants who received study medication and provided a baseline assessment.|||minutes||95% Confidence Interval|Median
2548878|NCT02863575|Secondary|Time to Onset of First Perceptible Relief|"When the participants were administered study medication at time 0 hours they were given the 2 stopwatches: 1 stopwatch was labelled as first perceptible relief and another as meaningful relief. Participants were instructed to stop the stopwatch labelled as first perceptible relief at the moment when they first began to feel any pain relieving effect. It was when they first felt a little/noticeable pain relief. It did not mean that they felt completely better (though they might), but when they first felt any difference in pain that they had at present. The stopwatch remained active for 8 hours (until stopped by the participants, or until rescue medication was administered)."|Up to 8 hours post-dose on Day 1|FAS population included all randomized participants who received study medication and provided a baseline assessment.|||minutes||95% Confidence Interval|Median
2548879|NCT02863575|Secondary|Time to Onset of Achieving Meaningful Relief|"When the participants were administered study medication at time 0 hours they were given the 2 stopwatches: 1 stopwatch was labelled as first perceptible relief and another as meaningful relief. Participants were instructed to stop the stopwatch labelled as meaningful relief at the moment when they first experienced meaningful relief, that is, when the relief from the pain was meaningful to them. The stopwatch remained active for 8 hours (until stopped by the participants, or until rescue medication was administered)."|Up to 8 hours post-dose on Day 1|FAS population included all randomized participants who received study medication and provided a baseline assessment.|||minutes||95% Confidence Interval|Median
2548880|NCT02863575|Secondary|Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose|"NPSR scale: at baseline and each post-dose time point participants answered to a question How much pain do you have at this time? on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a single post-dose time point: -10 to 10, higher positive value = greater improvement in pain."|0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1|FAS population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2548881|NCT02863575|Secondary|Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose|"PRR score: at each post-dose time point participants answered to a question How much relief do you have from your starting pain? on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain."|0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1|FAS population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2549030|NCT02862106|Secondary|The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144||week95,108,120,144|Intention to treat population|||percentage of paricipant|||Number
2548882|NCT02863575|Secondary|Sum of Pain Relief Rating and Pain Intensity Difference (PRID) Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose|"PRID: sum of PID and PRR at each post-dose time point. PRR score: at each post-dose time point participants answered to a question How much relief do you have from your starting pain? on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. NPSR scale: at baseline and each post-dose time point participants answered to a question How much pain do you have at this time? on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. At a single post-dose time point overall possible range for PRID score: -10 to 14, higher scores = more improvement in pain."|0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose on Day 1|FAS population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2548883|NCT02863575|Secondary|Time Weighted Sum of Pain Relief Rating Scores From 0 to 2 (TOTPAR 0-2), 0 to 4 (TOTPAR 0-4), 0 to 6 (TOTPAR 0-6) and 0 to 8 Hours Post-dose (TOTPAR 0-8)|"TOTPAR 0-2, TOTPAR 0-4, TOTPAR 0-6, TOTPAR 0-8: time-weighted sum of PRR scores from 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose respectively. PRR score: at each post-dose time point participants answered to the question How much relief do you have from your starting pain? on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. Overall possible range: TOTPAR 0-2 = 0 to 8; TOTPAR 0-4 = 0 to 16; TOTPAR 0-6 = 0 to 24; TOTPAR 0-8 = 0 to 32. Higher TOTPAR scores = more improvement in pain."|From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1|FAS population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2548884|NCT02863575|Secondary|Time Weighted Sum of Pain Intensity Difference Scores From 0 to 2 Hours (SPID 0-2), 0 to 4 (SPID 0-4), 0 to 6 (SPID 0-6) and 0 to 8 Hours Post-dose (SPID 0-8)|"SPID 0-2, SPID 0-4, SPID 0-6, SPID 0-8: time-weighted sum of PID scores from 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose respectively. NPSR scale: at baseline and each post-dose time point participants answered to question How much pain do you have at this time? on an 11-point scale: score range from 0 = no pain to 10 = worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. Overall possible range: SPID 0-2 = -20 to 20; SPID 0-4 = -40 to 40; SPID 0-6 = -60 to 60; SPID 0-8 = -80 to 80. Higher SPID scores = more improvement in pain."|From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1|FAS population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2548885|NCT02863575|Secondary|Time Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 2 (SPRID 0-2), 0 to 4 (SPRID 0-4), 0 to 6 (SPRID 0-6) and 0 to 8 Hours Post-dose (SPRID 0-8)|"SPRID 0-2, SPRID 0-4, SPRID 0-6, SPRID 0-8: time-weighted sum of PRID scores from 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours respectively. PRID at each post-dose time point = PID + PRR. PRR score: at each post-dose time point participants answered to question How much relief do you have from your starting pain? on 5-point scale: 0=none, 1=a little, 2=some, 3=a lot, 4=complete; higher scores=more relief from pain. NPSR scale: at baseline and each post-dose time point participants answered to question How much pain do you have at this time? on 11-point scale: range from 0=no pain to 10=worst possible pain; higher scores=worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value=greater improvement. Score range for: SPRID 0-2= -20 to 28; SPRID 0-4= -40 to 56; SPRID 0-6= -60 to 84; SPRID 0-8= -80 to 112. Higher SPRID scores=more improvement in pain."|From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1|FAS population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2548886|NCT02863575|Primary|Time Weighted Sum of Pain Relief Rating (PRR) and Pain Intensity Difference (PID) Scores From 0 to 8 Hours Post-dose (SPRID 0-8): Ibuprofen + Caffeine Versus Ibuprofen|"SPRID 0-8: time-weighted sum of PRID scores from 0 to 8 hours. PRID: sum of PID and PRR at each post-dose time point. PRR score: at each post-dose time point participants answered to question How much relief do you have from your starting pain? on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. Numerical pain severity rating (NPSR) scale: at baseline and each post-dose time point participants answered to question How much pain do you have at this time? on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. Overall possible SPRID 0-8 score range: -80 to 112, higher scores = more improvement in pain."|From 0 to 8 hours post-dose on Day 1|Full analysis set (FAS) population included all randomized participants who received study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2548887|NCT02863419|Secondary|Change in DTSQs: Individual Items and Total Treatment Satisfaction Score (6 of the 8 Items Summed)|"Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26 (wk 26) and week 52 (wk 52). The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction."|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Scores on a scale||Standard Deviation|Mean
2549031|NCT02862106|Primary|The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period|"Primary endpoint data were summarised under End of Study,using the last available post-baseline observation(Last Observation Carried Forward,LOCF)"|Endpoint (LOCF), up to 144 weeks|Intent-to-treat population|||percentage of participants|||Number
2548888|NCT02863419|Secondary|Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes|Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Weeks 0-57|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Participants|||Count of Participants
2548889|NCT02863419|Secondary|Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes|Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Weeks 0-57|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Episodes|||Number
2548890|NCT02863419|Secondary|Anti-semaglutide Binding Antibody Levels|This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-57). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-57|Overall number of participants analysed = participants who were found positive for anti-semaglutide antibodies.||||||
2548891|NCT02863419|Secondary|Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)|This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-57|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2548892|NCT02863419|Secondary|Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)|This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0-57|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2548893|NCT02863419|Secondary|Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)|This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-57|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2548894|NCT02863419|Secondary|Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)|This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (weeks 0-57) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-57|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2548895|NCT02863419|Secondary|Change in Eye Examination Category|Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week -2, Week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Participants|||Count of Participants
2548905|NCT02863419|Secondary|Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)|Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2548896|NCT02863419|Secondary|Change in Physical Examination|Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2) and weeks 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.|Week -2, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2548897|NCT02863419|Secondary|Change in ECG Evaluation|Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26 and week 52. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26 and week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2548898|NCT02863419|Secondary|Change in SBP and DBP|Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||mmHg||Standard Deviation|Mean
2548899|NCT02863419|Secondary|Change in Pulse Rate|Change from baseline (week 0) in pulse rate was evaluated at weeks 26 and 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Beats/min||Standard Deviation|Mean
2548900|NCT02863419|Secondary|Change in Lipase - Ratio to Baseline|Change from baseline (week 0) in lipase (U/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Ratio of lipase||Geometric Coefficient of Variation|Geometric Mean
2548901|NCT02863419|Secondary|Change in Amylase - Ratio to Baseline|Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Ratio of amylase||Geometric Coefficient of Variation|Geometric Mean
2548902|NCT02863419|Secondary|Number of Treatment-emergent Adverse Events (TEAEs) During Exposure to Trial Product|Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Weeks 0-57|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.|||Events|||Number
2548903|NCT02863419|Secondary|Time to Rescue Medication|Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Weeks 0-52|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2548904|NCT02863419|Secondary|Time to Additional Anti-diabetic Medication|Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-52|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2552323|NCT02796092|Secondary|Cost of Treatment|Cost of the differential devices used in each treatment procedure, assuming the same cost for the rest of the procedure, other material and hospital stay.|Intraoperative||||US Dollars||Standard Deviation|Mean
2548906|NCT02863419|Secondary|Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)|Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26 and 52 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2548907|NCT02863419|Secondary|Participants Who Achieve Weight Loss ≥ 10% (Yes/no)|Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2548908|NCT02863419|Secondary|Participants Who Achieve Weight Loss ≥5% (Yes/no)|Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2548909|NCT02863419|Secondary|Participants Who Achieve HbA1c <6.5% (48 mmol/Mol) AACE Target (Yes/no)|Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at weeks 26 and 52 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2548910|NCT02863419|Secondary|Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)|Participants who achieved HbA1c <7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2548911|NCT02863419|Secondary|Change in SMPG - Mean Postprandial Increment Over All Meals|Change from baseline (week 0) in the average of the post-prandial increments over all meals was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2548912|NCT02863419|Secondary|Change in SMPG - Mean 7-point Profile|Change from baseline (week 0) to week 26 and week 52 in mean 7-point self-measured plasma glucose (SMPG) profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2548913|NCT02863419|Secondary|Change in Free Fatty Acids - Ratio to Baseline|Change from baseline (week 0) in free fatty acids (FFA) (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of FFA||Geometric Coefficient of Variation|Geometric Mean
2548914|NCT02863419|Secondary|Change in Triglycerides - Ratio to Baseline|Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of triglycerides||Geometric Coefficient of Variation|Geometric Mean
2548978|NCT02863289|Primary|Number of Participants With Indicated Status as Assessed by Mail Questionnaire Upper Extremities Functional Index (UEFI)|Mail questionnaires based on the Upper Extremities Functional Index (UEFI) with return postages were sent out to the eligible cohort. UEFI range between 0 to 59, where the higher the UEFI, the better the functional outcomes.|From year 2008 to 2015||||Participants|||Count of Participants
2548915|NCT02863419|Secondary|Change in High-density Lipoprotein (HDL) Cholesterol - Ratio to Baseline|Change from baseline (week 0) in HDL cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of HDL-cholesterol||Geometric Coefficient of Variation|Geometric Mean
2548916|NCT02863419|Secondary|Change in Very Low Density Lipoprotein (VLDL) Cholesterol - Ratio to Baseline|Change from baseline (week 0) in VLDL cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of VLDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2548917|NCT02863419|Secondary|Change in Low-density Lipoprotein (LDL) Cholesterol - Ratio to Baseline|Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of LDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2548918|NCT02863419|Secondary|Change in Total Cholesterol - Ratio to Baseline|Change from baseline (week 0) in total cholesterol (mmol/L) at weeks 26 and 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of total cholesterol||Geometric Coefficient of Variation|Geometric Mean
2548919|NCT02863419|Secondary|Change in Waist Circumference|Change from baseline (week 0) in waist circumference was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||cm||Standard Deviation|Mean
2548920|NCT02863419|Secondary|Change in Body Mass Index|Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||kg/m^2||Standard Deviation|Mean
2548921|NCT02863419|Secondary|Change in Fasting Plasma Glucose|Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2548922|NCT02863419|Secondary|Change in Body Weight (%)|Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26 and 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, Week 26, Week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Percentage change||Standard Deviation|Mean
2548923|NCT02863419|Secondary|Change in Body Weight (Week 52)|Change from baseline (week 0) in body weight was evaluated at 52 weeks. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 52|Overall number of participants analyzed = number of participants with available data.|||Kg||Standard Deviation|Mean
2548924|NCT02863419|Secondary|Change in HbA1c (Week 52)|Change from baseline (week 0) in HbA1c was evaluated at 52 weeks. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 52|Overall number of participants analyzed = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2548925|NCT02863419|Secondary|Change in Body Weight (Week 26)|Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Week 0, week 26|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Kg||Standard Deviation|Mean
2548926|NCT02863419|Primary|Change in HbA1c (Week 26)|Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Week 0, week 26|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2548927|NCT02863328|Secondary|Change in CoEQ: Scores From the 4 Domains and the 19 Items|Change from baseline (week 0) in Control of Eating Questionnaire (CoEQ) was evaluated at weeks 26 and 52. The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control' (items 9-12, 19), 'positive mood' (items 5-8), 'craving for savoury' (items 4, 16-18) and 'craving for sweet' (items 3, 13-15). The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the data from the in-trial observation period.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2548928|NCT02863328|Secondary|Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)|SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26 and 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2548929|NCT02863328|Secondary|SNAC Plasma Concentrations|This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Sodium N-[8-(2-hydroxybenzoyl) amino]caprylate (SNAC) plasma concentrations were measured after 25 and 40 minutes post-dose at week 4, 26 and 52. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Weeks 0-52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2548930|NCT02863328|Secondary|Semaglutide Plasma Concentrations for Population PK Analyses|Semaglutide plasma concentrations were measured after 25 minutes post-dose at week 4, 26 and 52. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Weeks 0-52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Nanomoles per liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2548931|NCT02863328|Secondary|Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)|Number of participants with treatment-emergent severe or BG-confirmed symptomatic hypoglycaemic episodes was recorded during week 0-57. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Weeks 0-57|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Participants|||Count of Participants
2548932|NCT02863328|Secondary|Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes|Treatment-emergent hypoglycaemia is an episode with onset in the on-treatment observation period (the time period where participants are considered treated with trial product) and was assessed up to approximately 57 weeks (52-week treatment period plus the 5-week follow-up period). Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Weeks 0-57|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Episodes|||Number
2548979|NCT02863263|Other Pre-specified|Safety as Evaluated by Number of Local Adverse Events at the Target Pressure Ulcer|Examples of these local events are erythema, edema, itching, flare and rash.|12 weeks||||local adverse events|||Number
2552247|NCT02797522|Primary|Pharmacokinetics of ARC-521 Injection: Area Under the Plasma-Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf), Healthy Volunteers||Through 48 hours post-dose on Day 1|Analysis was not planned or conducted per SAP due to study termination.||||||
2548933|NCT02863328|Secondary|Anti-semaglutide Binding Antibody Levels|This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (week 0 to week 57). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Weeks 0-57|Overall number of participants analysed = participants who were found positive for anti-semaglutide antibodies.|||%B/T||Standard Deviation|Mean
2548934|NCT02863328|Secondary|Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)|This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (week 0 to week 57) are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Weeks 0-57|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2548935|NCT02863328|Secondary|Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)|This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (week 0 to week 57) are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Weeks 0-57|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2548936|NCT02863328|Secondary|Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)|This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (week 0 to week 57) are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Weeks 0-57|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2548937|NCT02863328|Secondary|Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)|This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (week 0 to week 57) are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Weeks 0-57|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2548938|NCT02863328|Secondary|Change in Eye Examination|The eye examination findings (normal, abnormal NCS and abnormal CS) of the participants at baseline (week -2) and week 52 are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week -2, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2548939|NCT02863328|Secondary|Change in Physical Examination|The physical examination findings (normal, abnormal NCS and abnormal CS) of the participants at week -2 and week 52 are presented for the following examinations: Cardiovascular system, Nervous system (central and peripheral); Gastrointestinal system, incl. mouth; General appearance; Head (ears, eyes, nose), throat, neck; Lymph node palpation; Musculoskeletal system; Respiratory system; Skin; Thyroid gland. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week -2, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2548940|NCT02863328|Secondary|Change in ECG|Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at week 26 and week 52. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS), and abnormal and clinically significant (CS)) from week 0 to week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2548941|NCT02863328|Secondary|Change in Blood Pressure (Systolic and Diastolic Blood Pressure)|Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 26 and week 52. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2552324|NCT02796092|Secondary|Number of Devices Used|Number of coils and number of vascular plugs used in each procedure|intraoperative||||devices||Standard Deviation|Mean
2548942|NCT02863328|Secondary|Change in Pulse Rate|Change from baseline (week 0) in pulse rate was evaluated at week 26 and week 52. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Beats/minute||Standard Deviation|Mean
2548943|NCT02863328|Secondary|Change in Lipase (Ratio to Baseline)|Change from baseline (week 0) in lipase (U/L) at week 26 and week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Ratio of lipase||Geometric Coefficient of Variation|Geometric Mean
2548944|NCT02863328|Secondary|Change in Amylase (Ratio to Baseline)|Change from baseline (week 0) in amylase (units per liter [U/L]) at week 26 and week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26, week 52|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Ratio of amylase||Geometric Coefficient of Variation|Geometric Mean
2548945|NCT02863328|Secondary|Number of Treatment-emergent Adverse Events (TEAE)|A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) with onset in the on-treatment observation period (the time period where participants are considered treated with trial product) and was assessed up to approximately 57 weeks (52-week treatment period plus the 5-week follow-up period).|Weeks 0-57|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.|||Events|||Number
2548946|NCT02863328|Secondary|Time to Rescue Medication|Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Rescue medication: use of new antidiabetic medication as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period: the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Weeks 0-52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS.|||Participants|||Count of Participants
2548947|NCT02863328|Secondary|Time to Additional Anti-diabetic Medication|Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26 and week 0 to week 52. Additional anti-diabetic medication: use of new anti-diabetic medication for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 26/week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Weeks 0-52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS.|||Participants|||Count of Participants
2548948|NCT02863328|Secondary|Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)|Participants who achieved HbA1c reduction ≥1%-point and weight loss of ≥3% at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2548949|NCT02863328|Secondary|Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)|Participants who achieved HbA1c <7.0% (53 mmol/mol) without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain at week 26 and week 52. Severe or BG-confirmed symptomatic hypoglycaemia: an episode, that is severe according to the ADA classification or BG-confirmed by a plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2548950|NCT02863328|Secondary|Participants Who Achieve Weight Loss ≥10% (Yes/no)|Participants who achieved weight loss of ≥10% at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2548951|NCT02863328|Secondary|Participants Who Achieve Weight Loss ≥5% (Yes/no)|Participants who achieved weight loss of ≥5% at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2548952|NCT02863328|Secondary|Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol), AACE Target (Yes/no)|Participants who achieved HbA1c ≤6.5% (48 mmol/mol) (American Association of Clinical Endocrinologists (AACE) target) at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2548953|NCT02863328|Secondary|Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) ADA Target (Yes/no)|Participants who achieved HbA1c <7.0% (53 mmol/mol) (American Diabetes Association (ADA) target) at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2548954|NCT02863328|Secondary|Change in Fasting Triglycerides (Ratio to Baseline)|Change from baseline (week 0) in fasting triglycerides (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Ratio of triglycerides||Geometric Coefficient of Variation|Geometric Mean
2548955|NCT02863328|Secondary|Change in Fasting Free Fatty Acids (Ratio to Baseline)|Change from baseline (week 0) in fasting free fatty acids (FFA) (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. Because of an issue with the handling of the blood samples for FFA, all FFA data are considered invalid for this trial; thus, no conclusion with regards to FFA levels can be made based on the FFA data. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Ratio of FFA||Geometric Coefficient of Variation|Geometric Mean
2548956|NCT02863328|Secondary|Change in Fasting VLDL Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in fasting very low density lipoprotein (VLDL) cholesterol (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Ratio of VLDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2548957|NCT02863328|Secondary|Change in Fasting HDL Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in fasting high density lipoprotein (HDL) cholesterol (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Ratio of HDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2548958|NCT02863328|Secondary|Change in Fasting LDL Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in fasting low density lipoprotein (LDL) cholesterol (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Ratio of LDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2548980|NCT02863263|Secondary|Number of Participants With New Infections at the Pressure Ulcer Based on Clinical Signs and Symptoms Checklist (CCSC)|"Patients with at least 1 new infection after the foam dressing application at baseline until Visit 14 will be taken into account.~Infection is defined as presence of purulent exudates or 2 or more symptoms stated in the CCSC. For patients with existing infection at baseline, infection is defined as the development of an additional symptom or recurrence of the baseline symptom after it was completely healed."|12 weeks||||Participants|||Count of Participants
2548959|NCT02863328|Secondary|Change in Fasting Total Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in fasting total cholesterol (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Ratio of total cholesterol||Geometric Coefficient of Variation|Geometric Mean
2548960|NCT02863328|Secondary|Change in Waist Circumference|Change from baseline (week 0) in waist circumference was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Centimetre (cm)||Standard Deviation|Mean
2548961|NCT02863328|Secondary|Change in Body Mass Index|Change from baseline (week 0) in body mass index (BMI) was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Kilograms per square meter (kg/m^2)||Standard Deviation|Mean
2548962|NCT02863328|Secondary|Change in Body Weight (%)|Relative change from baseline (week 0) in body weight (kg) was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Percentage change||Standard Deviation|Mean
2548963|NCT02863328|Secondary|Change in C-reactive Protein (Ratio to Baseline)|Change from baseline (week 0) in C-reactive protein (milligrams per liter [mg/L]) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Ratio of C-reactive protein||Geometric Coefficient of Variation|Geometric Mean
2548964|NCT02863328|Secondary|Change in HOMA-B (Ratio to Baseline)|Change from baseline (week 0) in homeostatic model assessment index of beta-cell function (HOMA-B) (%) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Ratio of HOMA-B||Geometric Coefficient of Variation|Geometric Mean
2548965|NCT02863328|Secondary|Change in HOMA-IR (Ratio to Baseline)|Change from baseline (week 0) in homeostatic model assessment index of insulin resistance (HOMA-IR) (%) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Ratio of HOMA-IR||Geometric Coefficient of Variation|Geometric Mean
2548966|NCT02863328|Secondary|Change in Fasting Glucagon (Ratio to Baseline)|Change from baseline (week 0) in fasting glucagon (picograms per milliliter [pg/mL]) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Ratio of glucagon||Geometric Coefficient of Variation|Geometric Mean
2548967|NCT02863328|Secondary|Change in Fasting Pro-insulin (Ratio to Baseline)|Change from baseline (week 0) in fasting pro-insulin (pmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Ratio of pro-insulin||Geometric Coefficient of Variation|Geometric Mean
2552530|NCT02793154|Primary|Part A: Albumin Level in Urine at Indicated Time Points|Samples were collected to analyze albumin level in urine. Individual Par. data at indicated time point has been collected.|Day 5|All Subjects Population|||Milligrams per liter|||Number
2548968|NCT02863328|Secondary|Change in Fasting Insulin (Ratio to Baseline)|Change from baseline (week 0) in fasting insulin (picomoles per liter [pmol/L]) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Ratio of insulin||Geometric Coefficient of Variation|Geometric Mean
2548969|NCT02863328|Secondary|Change in Fasting C-peptide (Ratio to Baseline)|Change from baseline (week 0) in fasting C-peptide (Nanomoles per liter [nmol/L]) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Ratio of C-peptide||Geometric Coefficient of Variation|Geometric Mean
2548970|NCT02863328|Secondary|Change in SMPG : Mean Postprandial Increment Over All Meals|Change from baseline (week 0) in mean postprandial glucose increment was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2548971|NCT02863328|Secondary|Change in SMPG : Mean of the 7-point Profile|Change from baseline (week 0) in mean of the 7-point self-measured plasma glucose (SMPG) (i.e. before and after breakfast, lunch and dinner, and at bedtime) profile was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26 and week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2548972|NCT02863328|Secondary|Change in Fasting Plasma Glucose|Change from baseline (week 0) in fasting plasma glucose was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 26, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2548973|NCT02863328|Secondary|Change in Body Weight (kg)|Change from baseline (week 0) in body weight was evaluated at week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 52|Overall number of participants analyzed = number of participants with available data.|||Kg||Standard Deviation|Mean
2548974|NCT02863328|Secondary|Change in HbA1c (%)|Change from baseline (week 0) in HbA1c was evaluated at week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product.|Week 0, week 52|Overall number of participants analyzed = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2548975|NCT02863328|Secondary|Change in Body Weight (Kg)|Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26|Overall number of participants analyzed = FAS which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Kilogram (Kg)||Standard Deviation|Mean
2548976|NCT02863328|Primary|Change in HbA1c|Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on data from the in-trial observation period which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication.|Week 0, week 26|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants, however, one participant was randomised twice and thereby included only once in the FAS. Number Analyzed = number of participants with available data.|||Percentage-point of HbA1c||Standard Deviation|Mean
2548977|NCT02863289|Secondary|Number of Participants With Indicated Outcomes as Assessed by Radiological Parameters|All shoulder X-rays performed in patients aged from 10 to 18-year-old and from 2008 to 2015 were reviewed. Radiological parameters, including degree of displacement and angulation; and any radiological residual deformities were recorded.|From year 2008 to 2015||||Participants|||Count of Participants
2548982|NCT02863263|Secondary|Number of Participants With a Dressing Change Frequency Greater Than Twice Per Week||12 weeks|The original Outcome Measure was frequency of additional dressing change. However, statistical analysis for this outcome measure was not performed due to low enrolment and early study termination. Therefore, the number of participants with dressing changes of more than twice weekly is reported instead.|||participants|||Number
2548983|NCT02863263|Secondary|Pressure Ulcer Scale for Healing (PUSH) Score Measured Using PUSH Tool Version 3.0 At Week 12|"The PUSH score is measured at alternate visits (2-week intervals) starting from baseline and will be compared against baseline.~Minimum score= 0 Maximum score: 17 Higher score: worse outcome"|Week 12 (Or Last Observation Carried Forward)|Statistical analysis for this outcome measure was not performed due to low enrolment and early study termination.|||score on a scale||Full Range|Median
2548984|NCT02863263|Primary|Pressure Ulcer Size Measured Using A Ruler at Week 12|The ulcer area (for ulcers without re-epithelization) is measured at each visit after foam dressing application. A photograph of the ulcer is taken and a using a ruler (MediRuleⓇ) is used to measure its length and width to obtain the area in cm2.|Week 12 (Or Last Observation Carried Forward)|Statistical analysis for this outcome measure was not performed due to low enrolment and early study termination.|||cm2||Full Range|Median
2548985|NCT02863263|Primary|Time to Complete Healing of Ulcer Within 12 Weeks as Measured by Number of Days From Baseline|Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration.|12 weeks|There is no analysis and result for this outcome measure as none of the subjects achieved complete healing of ulcer within 12 weeks.||||||
2548986|NCT02863263|Primary|Number of Patients With Complete Healing of Ulcer Within 12 Weeks|Complete healing is defined as epithelial tissue covering 100% of the ulcer, with intact dermis and epidermis and without abrasion or ulceration.|12 weeks||||Participants|||Count of Participants
2548987|NCT02863198|Secondary|Pregnancy Rate Between the Study and the Control Group|detection of serum pregnancy tests for both groups( study and the control group)|3 weeks||||participants|||Number
2548988|NCT02863198|Primary|Spiral Artery Doppler Resistance Indices in All Patients|Spiral artery Doppler resistance indices between study and control groups on the day of human chorionic gonadotropin administration.it is an indicator of resistance of Spiral artery to perfusion . In ultrasonography,it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity.lower values are better than higher values.|one week||||index||Standard Deviation|Mean
2548989|NCT02863198|Primary|Spiral Artery Pulsatility Indices in All Patients|Spiral artery Doppler pulsatility indices between study and control groups on the day of human chorionic gonadotropin administration.Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance|one week||||index||Standard Deviation|Mean
2548990|NCT02863198|Primary|Appearance of Sub Endometrial Blood Flow in All Patients|Appearance of sub endometrial blood flow between patients of study and control groups on the day of human chorionic gonadotropin administration. subendometrial blood flow distribution pattern was determined by demonstrating pulsatile color signals in the sub endometrial area.The number of patients demonstrating subendometrial blood flow distribution pattern are collected .|one week||||participants|||Number
2548991|NCT02863198|Primary|Measurement of Uterine Artery Resistance Index|measurement of uterine artery resistance index at day of human chorionic gonadotropin administration.it is an indicator of resistance of uterine artery to perfusion . In ultrasonography, it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity.lower values are better than higher values.|one week||||index||Standard Deviation|Mean
2548992|NCT02863198|Primary|Measurement of Uterine Artery Pulsatility Index|measurement of uterine artery pulsatility index at day of human chorionic gonadotropin administration.Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance.|one week||||index||Standard Deviation|Mean
2548993|NCT02862730|Secondary|Mean Amount of Glucagon Delivered|Assess the average amount of insulin delivered per day in units/kg as documented through the artificial pancreas controller in dual hormone arm.|24 hours|All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.|||mcg/kg||Standard Deviation|Mean
2548994|NCT02862730|Secondary|Mean Amount of Insulin Delivered|Assess the average amount of insulin delivered per day in units/kg as documented through the artificial pancreas controller across all four arms.|24 hours|All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.|||units/kg||Standard Deviation|Mean
2548995|NCT02862730|Secondary|Number of Events With Capillary Blood Glucose < 3.0 mmol/L|Assess number of events with capillary blood glucose < 3.0 mmol/L using downloads from a Contour Next blood glucose meter across all four arms.|entire 84 hour study|All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.|||number of events||Standard Deviation|Mean
2548996|NCT02862730|Secondary|Number of Events With Capillary Blood Glucose < 3.9 mmol/L|Assess number of events with capillary blood glucose < 3.9 mmol/L using downloads from a Contour Next blood glucose meter across all four arms. .|entire 84 hour study|All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.|||number of events||Standard Deviation|Mean
2548997|NCT02862730|Secondary|Percent of Time With Sensed Glucose > 10 mmol/L|Assess the percent of time that the Dexcom G4 Share reported sensor glucose values greater than 10 mmol/L using Dexcom sensor downloads across all four arms|entire 84 hour study|All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.|||percentage of 84 hours||Standard Deviation|Mean
2548998|NCT02862730|Secondary|Percent of Time With Sensed Glucose < 3.0 mmol/L|Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.0 mmol/L using Dexcom sensor downloads across all four arms.|entire 84 hour study|All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.|||percentage of 84 hours||Standard Deviation|Mean
2549001|NCT02862730|Primary|Percent of Time With Sensed Glucose Between 3.9-10 mmol/L|Assess the percent of time that the Dexcom G4 Share reported sensor glucose values between 3.9-10 mmol/L using Dexcom sensor downloads across all four arms.|From 14:00-18:00 for each 12 hour inpatient visit|All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.|||percentage of 4 hours after exercise||Standard Deviation|Mean
2549002|NCT02862730|Primary|Percent of Time With Sensed Glucose Between 3.9-10 mmol/L|Assess the percent of time that the Dexcom G4 Share reported sensor glucose values between 3.9-10 mmol/L using Dexcom sensor downloads across all four arms.|entire 84 hour study|All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.|||percentage of 84 hours||Standard Deviation|Mean
2549003|NCT02862730|Primary|Percent of Time With Sensed Glucose < 3.9 mmol/L|Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.9 mmol/L using Dexcom sensor downloads across all four arms.|From 14:00-18:00 for each 12 hour inpatient visit|All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.|||percentage of 4 hours after exercise||Standard Deviation|Mean
2549004|NCT02862730|Primary|Percent of Time With Sensed Glucose < 3.9 mmol/L|Assess the percent of time that the Dexcom G4 Share reported sensor glucose values less than 3.9 mmol/L using Dexcom sensor downloads across all four arms.|entire 84 hour study|All subjects analyzed for those who started a PLGS, SH, DH or SAP arm.|||percentage of 84 hours||Standard Deviation|Mean
2549005|NCT02862600|Secondary|Change From Baseline in the Six-minute Walk Test at the End of Period 1|At the conclusion of 8 weeks of perhexiline treatment, 6MWD was measured and compared to 6MWD measured at baseline.|end of Period 1 (Week 8)||||meters||Standard Deviation|Mean
2549006|NCT02862600|Secondary|Change From Baseline in the Six-minute Walk Test at the End of Period 2|At the conclusion of 16 weeks of perhexiline treatment, 6MWD was measured and compared to 6MWD measured at baseline.|end of Period 2 (Week 16)||||meters||Standard Deviation|Mean
2549007|NCT02862600|Secondary|Change From Baseline of VO2MAX at End of Period 1|At the conclusion of 8 weeks of perhexiline treatment, MVO2 was measured using CPEX and compared to MVO2 measured at baseline.|end of Period 1 (Week 8)||||ml/kg/min||Standard Deviation|Mean
2549008|NCT02862600|Primary|Change From Baseline of VO2MAX at 16 Weeks|At the conclusion of 16 weeks of perhexiline treatment, MVO2 was measured using CPEX and compared to MVO2 measured at baseline.|end of Period 2 (Week 16)||||ml/kg/min||Standard Deviation|Mean
2549009|NCT02862574|Secondary|Plasma Concentration of Andecaliximab|The plasma concentrations of andecaliximab were not collected and were not analyzed.|Day 4 or 6 (± 1 day)|||||||
2549010|NCT02862574|Secondary|Percentage of Participants That Achieve DAS28(CRP) < 2.6 at Week 12|The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug|||percentage of participants|||Number
2549011|NCT02862574|Secondary|Percentage of Participants That Achieve DAS28(CRP) ≤ 3.2 at Week 12|The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug|||percentage of participants|||Number
2549012|NCT02862574|Primary|Change From Baseline in DAS28(CRP) at Week 12|The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|Baseline; Week 12|Participants in the Full Analysis Set (all randomized participants who received at least 1 dose of study drug) with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2549013|NCT02862548|Secondary|Change From Baseline in Serum Creatinine at Week 48||Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
2549014|NCT02862548|Secondary|Change From Baseline in Serum Creatinine at Week 24||Baseline; Week 24|Participants in the Safety Analysis Set were analyzed.|||mg/dL||Standard Deviation|Mean
2549015|NCT02862548|Secondary|Percent Change From Baseline in Spine BMD at Week 48||Baseline; Week 48|Participants in the Spine DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2549016|NCT02862548|Secondary|Percent Change From Baseline in Spine BMD at Week 24||Baseline; Week 24|Spine DXA Analysis Set included participants who were randomized and had received at least 1 dose of study drug, and had nonmissing baseline spine BMD values.|||percentage change||Standard Deviation|Mean
2549017|NCT02862548|Secondary|Percent Change From Baseline in Hip BMD at Week 48||Baseline; Week 48|Participants in the Hip DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2549018|NCT02862548|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 24||Baseline; Week 24|Hip dual energy x-ray absorptiometry (DXA) Analysis Set included participants who were randomized and had received at least 1 dose of study drug, and had nonmissing baseline hip BMD values.|||percentage change||Standard Deviation|Mean
2549019|NCT02862548|Secondary|Percentage of Participants With HBV DNA < 20 IU/mL at Week 48||Week 48|Participants in the Full Analysis Set were analyzed. The missing = failure approach was used.|||percentage of participants|||Number
2549020|NCT02862548|Secondary|Change From Baseline in Serum eGFR_CKD-EPI at Week 48||Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Standard Deviation|Mean
2549021|NCT02862548|Primary|Percentage of Participants With HBV DNA < 20 IU/mL at Week 24||Week 24|Full Analysis Set included all randomized participants who have received at least 1 dose of study drug. The missing = failure approach was used.|||percentage of participants|||Number
2549032|NCT02861807|Other Pre-specified|Improvements in Inhibitory Control|"To examine inhibitory control, the investigators will use a Stop Signal Task in which participants make left-right judgments of the directionality of an arrow presented on the screen. For each trial, a circle will appear for 500 ms, followed by a left or right-pointing arrow for up to 1 second and between 500 ms and 2500 ms jittered inter-trial interval to reduce anticipatory responses. Approximately 25% of trials will be stop trials with a tone played to signal participants to inhibit the current response. This timing of the tone is dynamically adjusted to ensure successful inhibition on approximately 50% of trials. There will be 240 trials across 6 blocks (~10 minutes). Inhibitory control is measured by stop signal reaction time."|Post-treatment||||milliseconds||Standard Deviation|Mean
2549033|NCT02861807|Other Pre-specified|Reductions in Self-reported Craving|Self-reported craving will be measured using the Penn Alcohol Craving Scale (scaled from 0 to 5 with higher scores indicate worse outcome = more craving) with higher scores mean a worse outcome.|2 months following treatment||||Score on a scale||Standard Deviation|Mean
2549034|NCT02861807|Other Pre-specified|Cue Reactivity at the Post-Treatment Assessment|To measure cue reactivity to alcohol, the investigators will use a visual cue presentation task. Participants will view pictures of alcohol containing beverages and neutral pictures from the International Affective Pictures Series (IAPS)118 and from the web. Alcohol and neutral pictures will be matched for color and complexity as well as other potentially important confounds (e.g., presence of people). The investigators will examine responses to approximately 100 trials each of alcohol pictures and control pictures in a mixed event design (~15 minutes), in order to reduce predictability of the picture type. After viewing pictures participants reported craving for alcohol on a scale from 1 to 9 (1=no craving, 9=extreme craving) with higher scores indicating worse outcomes.|Post-treatment||||Score on a scale||Standard Deviation|Mean
2549035|NCT02861807|Secondary|Percent Heavy Drinking Days|The Form 90 will be used to derive estimates of the secondary outcome: percent heavy drinking days, where heavy drinking is defined as 4+ drinks per occasion for women and 5+ drinks per occasion for men.|Post-treatment and 2-month follow-up||||percentage of heavy drinking days||Standard Deviation|Mean
2549036|NCT02861807|Primary|Drinks Per Drinking Day|The Form 90 will be used to derive estimates of the primary outcome: drinks (standard drink=14 grams of pure alcohol) per drinking day.|Post-treatment and 2-month follow-up||||drinks per drinking day||Standard Deviation|Mean
2549037|NCT02861664|Secondary|Change From Baseline in Tactile Threshold at Week 4 and 8|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|At Baseline, Week 4 and Week 8|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. Number of participants analyzed is the number of participants from ITT population evaluated at specific time point for each treatment arm respectively.|||g||Standard Deviation|Mean
2549038|NCT02861664|Secondary|Change From Baseline in Schiff Sensitivity Score at Week 4|The examiner assessed the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale as follows: 0 Participant does not respond to air stimulation, 1 Participant responds to air stimulus but does not request discontinuation of stimulus, 2 Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3 Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|At Baseline and Week 4|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. Number of participants analyzed is number of participants from ITT population evaluated at Week 4.|||score on a scale||Standard Deviation|Mean
2549039|NCT02861664|Primary|Change From Baseline in Schiff Sensitivity Score at Week 8|The examiner assessed the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff Sensitivity Scale as follows: 0 Participant does not respond to air stimulation, 1 Participant responds to air stimulus but does not request discontinuation of stimulus, 2 Participant responds to air stimulus and requests discontinuation or moves from stimulus, 3 Participant responds to stimulus, considers stimulus to be painful and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|At Baseline and Week 8|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
2549040|NCT02861131|Other Pre-specified|Number of Participants Diagnosed With a National Surgical Quality Improvement Program (NSQIP) Defined Respiratory Complication|pneumonia, unplanned re-intubation for any reason other than a return trip to the operating room, and ventilator times greater than 48 hours - excluding operating room time|Length of hospitalization, an average of 1 week||||Participants|||Count of Participants
2549041|NCT02861131|Other Pre-specified|Number of Participants With Hospital Readmission Within 30 Days|The proportion of patients that require hospital readmission for any cause within 30 days of hospital discharge|Length of hospitalization plus 30 days post-discharge||||Participants|||Count of Participants
2549042|NCT02861131|Other Pre-specified|Hospital Length of Stay|Defined as the number of days between hospital admission and discharge|Length of hospitalization, an average of 1 week||||days||Standard Deviation|Mean
2549043|NCT02861131|Secondary|PACU Phase 1 Recovery Time|Defined as duration of time required to attain pain control and stable respiratory, haemodynamic, and neurological status|1 day||||minutes||Standard Deviation|Mean
2549044|NCT02861131|Secondary|Number of Participants With Residual Neuromuscular Blockade in the PACU|Residual neuromuscular blockade will be defined as a train-of-four ratio < 0.9 taken within 5 minutes of subject arrival in the PACU|1 day||||Participants|||Count of Participants
2552248|NCT02797522|Primary|Pharmacokinetics of ARC-521 Injection: Area Under the Plasma-Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast), Healthy Volunteers||Through 48 hours post-dose on Day 1|Analysis was not planned or conducted per SAP due to study termination.||||||
2549045|NCT02861131|Primary|Number of Participants With a Postoperative Pulmonary Complication|A composite outcome which includes any of the following: postoperative pneumonia, aspiration pneumonitis, atelectasis, pneumothorax, desaturation/hypoxemia, upper airway obstruction, or acute respiratory insufficiency|Length of hospitalization, an average of 1 week||||Participants|||Count of Participants
2549046|NCT02861118|Secondary|Percentage of UC Participants With Comorbidities According to the Level of IBD Severity|Participants with UC were classified into IBD severe or non-severe at baseline based on the PMS scores according the following criteria:- PMS score includes 3 sub-scores: stool frequency (0=normal to 3=>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score is sum of sub scale scores ranging from 0=normal to 9=severe disease.|Day 1|Analyzed participants included all participants who didn’t had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment. Number analyzed is the number of participants with evaluable data at the given time-point.|||percentage of participants|||Number
2549047|NCT02861118|Secondary|Percentage of CD Participants With Comorbidities According to the Level of IBD Severity|Participants with CD were classified into IBD severe or non-severe at baseline based on the HBI scores according the following criteria:- HBI includes general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools per day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score is sum of sub scores, score <5=remission, 5-7=mild disease, 8-16=moderate disease and >16=severe disease.|Day 1|Analyzed participants included all participants who didn’t had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment. Number analyzed is the number of participants with evaluable data at the given time-point.|||percentage of participants|||Number
2549048|NCT02861118|Secondary|Percentage of IBD Participants With Comorbidities|Participants with CD and UC along with comorbidities were reported. Comorbidity referred to the presence of co-existing or additional diseases with reference to an initial diagnosis or with reference to the index condition.|Day 1|Analyzed participants included all participants who didn’t had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment. Number analyzed is the number of participants with evaluable data at the given time-point.|||percentage of participants|||Number
2549049|NCT02861118|Secondary|Impact of the Extraintestinal Manifestations Profile in IBD Participants on Loss of Treatment Response to Biological Therapy|Correlation between extraintestinal manifestations profile and loss of response, adjusted for sociodemographic and clinical profile, logistic regression models were conducted. Loss of response was deﬁned as loss of drug effect along follow up with initial response i.e. reduction of 2 points from baseline in HBI score for CD or PMS for UC after 6 months of treatment with anti-TNF. HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, <5=remission, 5-7=mild disease, 8-16=moderate disease and >16=severe disease. PMS score included 3 sub-scores: stool frequency (0=normal to 3=>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores ranging from 0=normal to 9=severe disease.|Up to 6 months after start of treatment with biologics|Analyzed participants included all participants who didn’t had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment.|||odds ratio||95% Confidence Interval|Number
2549050|NCT02861118|Secondary|Impact of the Extraintestinal Manifestations Profile in IBD Participants on Lack of Treatment Response to Biological Therapy|Correlation between extraintestinal manifestations profile and lack of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Lack of response was reduction of at least 2 points from baseline in HBI score for CD or PMS for UC after 10 weeks treatment with TNF. HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, where score <5=remission, 5-7=mild disease, 8-16=moderate disease and >16-severe disease. PMS included 3 sub-scores: stool frequency (0=normal to 3=>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores from 0=normal to 9=severe disease.|Up to 10 weeks after start of treatment with biologics|Analyzed participants included all participants who didn’t had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment.|||odds ratio||95% Confidence Interval|Number
2549051|NCT02861118|Primary|Impact of the Comorbidities Profile in IBD Participants on Loss of Treatment Response to Biological Therapy|Correlation between co-morbidities profile and loss of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Loss of response was deﬁned as loss of drug effect along follow up with initial response i.e. reduction of 2 points from baseline in HBI score for CD or PMS for UC after 6 months of treatment with anti-TNF. HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, <5=remission, 5-7=mild disease, 8-16=moderate disease and >16=severe disease. PMS score included 3 sub-scores: stool frequency (0=normal to 3=>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores ranging from 0=normal to 9=severe disease.|Up to 6 months after start of treatment with biologics|Analyzed participants included all participants who didn’t had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment.|||odds ratio||95% Confidence Interval|Number
2549084|NCT02858492|Secondary|Change From Baseline in Maximal Signal Intensity Enhancement (ME)|Maximum enhancement (ME) is a measure of the maximum concentration of contrast agent in the tissue over the duration of the DCE-MRI time series. ME was measured by DCE-MRI in most affected hand/wrist at indicated time points. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimole||Standard Deviation|Mean
2549052|NCT02861118|Primary|Impact of the Comorbidities Profile in Inflammatory Bowel Disease (IBD) Participants on Lack of Treatment Response to Biological Therapy|Correlation between co-morbidities profile and lack of response, adjusted for sociodemographic and clinical profile of participants, logistic regression models were conducted. Lack of response was reduction of 2 points from baseline in Harvey-Bradshaw Indices (HBI) score for CD or Partial Mayo score (PMS) for UC after 10 weeks treatment with anti-tumour necrosis factor (TNF). HBI included general well-being (0=very well to 4=terrible), abdominal pain (0=none to 3=severe), number of liquid stools/day, abdominal mass (0=none to 3=tender), and complications (8 items; 1 score/item). The total score was sum of sub scores, where score <5=remission, 5-7=mild disease, 8-16=moderate disease and >16-severe disease. PMS included 3 sub-scores: stool frequency (0=normal to 3=>4 stools/day more than normal), rectal bleeding (0=none to 3=passing blood alone), and physician's global assessment (0=Normal to 3=severe). The total score was sum of sub scale scores from 0=normal to 9=severe disease.|Up to 10 weeks after start of treatment with biologics|Analyzed participants included all participants who didn’t had screen failure, met all the inclusion criteria and had enough information about response to the biological treatment.|||odds ratio||95% Confidence Interval|Number
2549053|NCT02860845|Secondary|Number of Participants With Recurrent Infections|Descriptive of the proportion of patients with vulvovaginitis recurrence|At 3 months after recruitment||||Participants|||Count of Participants
2549054|NCT02860845|Secondary|Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures.|Lactobacillus spp count. in vaginal discharge at baseline and at visit 1, determined by vaginal cultures.|Baseline and 2 weeks after treatment finalization||||Count of Organism/counting chamber||Standard Deviation|Mean
2549055|NCT02860845|Primary|Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score.|Semi-quantitative scale where itching, erythema, edema, stinging and abnormal vaginal discharge are scored from 0 to 3: absent (0), mild (1), moderate (2), severe (3). Worse result is 3 (severe)|Baseline and at 2 weeks after treatment finalization|Subscore Sobel Score values at baseline and visit 1 (from 0 to 3)|||score on a scale||Standard Deviation|Mean
2549056|NCT02860507|Secondary|Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications||through discharge from hospital, average of 72 hours||||Participants|||Count of Participants
2549057|NCT02860507|Primary|Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate.||through start of next surgery, average of 2 hours||||Minutes||Standard Deviation|Mean
2549058|NCT02860169|Primary|Change in Mood and Motivation Visual Analogue Scale (VAS) Change (Millimeter[mm]) in Participants Suffering From Cold and Flu Versus Healthy Participants|VAS of 100mm line will be used to assess subjective ratings of mood and motivation. For mood participants will be asked to rate their current mood under the headings of alertness, pleasure/displeasure and anxiety. Motivation will be assessed by asking participants to rate their current motivation under six different headings e.g. general motivation, motivation to engage with friends and family and motivation to perform leisure activities (In Part B of the study).|Day 1|No participant data were analysed for the study as it was terminated due to concerns relating to procedures for data collection. Based on these concerns, GSK is not confident that the data collected in this study could support reliable interpretation of the assessments and conclusions on the primary objectives of the study.||||||
2549059|NCT02860169|Primary|Change in Attention Switching Task (AST) Score (Congruency Cost [ms]) in Participants Suffering From Cold and Flu Versus Healthy Participants|"Change in AST score is a measure of executive attention. The test displays an arrow which can appear on either side of the screen (right or left) and can point in either direction (to the right or to the left). Each trial displays a cue at the top of the screen that indicates to the participant whether they have to press the right or left button according to the side on which the arrow appeared or the direction in which the arrow was pointing. AST congruency cost (median; ms) will be measured as the difference between the median latency of response (from stimulus appearance to button press) on the trials that were congruent versus the trials that were incongruent. Calculated by subtracting the median congruent latency (ms) from the median incongruent latency. Close to zero: less variation in latencies across congruent and incongruent trials. A positive score: participant is faster on congruent trials and a negative score: participant is faster on incongruent trials (in Part C)."|Day 1|No participant data were analysed for the study as it was terminated due to concerns relating to procedures for data collection. Based on these concerns, GSK is not confident that the data collected in this study could support reliable interpretation of the assessments and conclusions on the primary objectives of the study.||||||
2549060|NCT02860169|Primary|Change in Rapid Visual Information Processing (RVP) A Prime (RVP A') in Participants Suffering From Cold and Flu Versus Healthy Participants|RVP A Prime will be measured with the help of a white box appears in the centre of computer screen inside which digits, from 2 to 9, appear in a pseudo-random order, at the rate of 100 digits per minute. Participants are requested to detect target sequences of digits (for example, 2-4-6, 3-5-7, 4-6-8) and to register responses using the press pad. RVP A Prime is the signal detection measure of sensitivity to the target, regardless of response tendency (the expected range is 0.00 to 1.00; bad to good). In essence, this metric is a measure of how good the participant is at detecting target sequences (In Part B of the study).|Day 1|No participant data were analysed for the study as it was terminated due to concerns relating to procedures for data collection. Based on these concerns, GSK is not confident that the data collected in this study could support reliable interpretation of the assessments and conclusions on the primary objectives of the study.||||||
2549061|NCT02860169|Primary|Change in Emotional Recognition Task (ERT) Score (Number of Total Hits) in Participants Suffering From Cold and Flu Versus Healthy Participants|Change in ERT will be measured by displaying Morphed images of real participant's facial features, each showing a specific emotion on the screen for 200ms. The participant will need to decide from 6 options which emotion the face is displaying. Change in ERT (total hits) which is calculated from the number of problems during assessment blocks, on which the participant chose the correct emotion (In Part B of the study).|Day 1|No participant data were analysed for the study as it was terminated due to concerns relating to procedures for data collection. Based on these concerns, GSK is not confident that the data collected in this study could support reliable interpretation of the assessments and conclusions on the primary objectives of the study.||||||
2549062|NCT02860169|Primary|Change in Reaction Time (RTI) Milliseconds (ms) From the Reaction Time Task in Participants Suffering From Cold and Flu Versus Healthy Participants|Change in RTI will be measured by the five-choice reaction time task. The participant will hold down a button at the bottom of the screen until a yellow spot appears in one of the five circles at the top of the screen. Median from five-choice reaction time (the median duration between the onset of the stimulus and the release of the button) will be measured (In Part B of the study).|Day 1|No participant data were analysed for the study as it was terminated due to concerns relating to procedures for data collection. Based on these concerns, GSK is not confident that the data collected in this study could support reliable interpretation of the assessments and conclusions on the primary objectives of the study.||||||
2549063|NCT02860169|Primary|Liking Rating on 11 Point Likert Scale (0-10 - 0 = Not at All; 10 = Like Extremely)|"Participants will be asked to rate a selection of images relevant to cold and flu on an 11 point Likert scale of how much do you like this image? from 0 = Not at all to 10 = Extremely like (In Part A of the study)."|At Screening|No participant data were analysed for the study as it was terminated due to concerns relating to procedures for data collection. Based on these concerns, GlaxoSmithKline (GSK) is not confident that the data collected in this study could support reliable interpretation of the assessments and conclusions on the primary objectives of the study.||||||
2549064|NCT02859597|Secondary|Number of Participants Who Need an Increase in Fraction of Inspired Oxygen|Need to increase the FiO2 to maintain adequate oxygenation|During period of sedation, on average up to 1 hour||||Participants|||Count of Participants
2549065|NCT02859597|Secondary|Number of Participants Requiring Airway Adjuncts During Procedure|The use of airway adjuncts such as oral and nasal airways to insure adequate oxygenation during procedure.|During the period of sedation, on average up to 1 hour||||Participants|||Count of Participants
2549066|NCT02859597|Primary|Ability to Maintain Oxygenation|The ease at which the Anesthesiologist is able to maintain adequate oxygenation during the period of sedation required for the procedure. the ability of each oxygen device to maintain oxygenation was based on the number of manipulations; more manipulations, the device is less effective at maintaining saturation for this population.|During the period of sedation, on average up to 1 hour||||manipulations||Standard Deviation|Mean
2549067|NCT02859454|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 28 months and 20 days.||||Participants|||Count of Participants
2549068|NCT02859454|Secondary|Duration of Clinical Responses to Avelumab|The duration of clinical responses to Avelumab is calculated from the protocol end of treatment endoscopic debulking to the next clinically indicated endoscopic debulking procedure.|Disease response was performed at 6 and 12 weeks after the first dose of Avelumab. Patients who experience a complete response will be evaluated every 6 weeks x 3, then every 12 weeks x 3, then every 26 weeks x 2 or until disease progression,up to 3 years||2020-09-30|09/2020||||
2549069|NCT02859454|Secondary|Number of Patients With Pulmonary Recurrent Respiratory Papillomatosis (RPP) Who Achieve a Partial Response With Avelumab as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Calculated From Chest Computed Tomography (CT) Scans|Partial response assessed by imaging using RECIST v1.1. is defined as a ≥ 30% decrease in the sum of the longest diameters of target lesions compared with baseline.|Disease response was performed at 6 and 12 weeks after the first dose of Avelumab. Patients who experience a complete response will be evaluated every 6 weeks x 3, then every 12 weeks x 3, then every 26 weeks x 2 or until disease progression, up to 3 year|Four of twelve patients had evaluable pulmonary disease as assessed by CT scan.|||Participants|||Count of Participants
2549070|NCT02859454|Secondary|Number of Patients With Laryngotracheal Recurrent Respiratory Papillomatosis (RPP) Who Achieve a Partial Response With Avelumab as Measured by Derkay Score Calculated From Clinical Endoscopy|Partial response is assessed by flexible nasopharyngolaryngoscopy and/or tracheoscopy using the Derkay staging system if the patient does not have pulmonary disease. The Derkay is an objective score based on the number of sites and bulkiness of papillomas within the pharynx, larynx and trachea and a subjective score determined by voice and treating symptoms. Partial response is a decrease in Derkay anatomic score of 30% or greater.|Disease response was performed at 6 and 12 weeks after the first dose of Avelumab. Patients who experience a complete response will be evaluated every 6 weeks x 3, then every 12 weeks x 3, then every 26 weeks x 2 or until disease progression,up to 3 years|Nine of twelve patients had evaluable laryngotracheal disease as assessed by clinical endoscopy.|||Participants|||Count of Participants
2549071|NCT02859454|Secondary|Effect of Treatment With Avelumab on Voice Handicap Index-10 Score|The Voice Handicap Index-10 questionnaire (as measured by derkay score) consists of 10 questions and determines whether a participant has a voice handicap. The scoring options for each question range from 0 (for never) to 4 (for always). The total scores (combined value from all 10 questions) range from 0 - 40. Higher scores represent a worse voice handicap. Lower scores represent a less voice handicap.|Baseline, 6 weeks, and 12 weeks after the first dose of Avelumab.|Only one participant in each row contributed data in each row.|||scores on a scale|||Number
2549072|NCT02859454|Primary|Number of Patients With Pulmonary Recurrent Respiratory Papillomatosis (RPP) Who Achieve a Complete Response With Avelumab as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Calculated From Chest Computed Tomography (CT) Scans|Complete response is measured by The Response Criteria in Solid Tumors (RECIST) v1.1 calculated from chest CT scans. Complete response is absence of disease (e.g., lesions) by imaging.|Disease response was performed at 6 and 12 weeks after the first dose of Avelumab. Patients who experience a complete response will be evaluated every 6 weeks x 3, then every 12 weeks x 3, then every 26 weeks x 2 or until disease progression,up to 3 years|Four of twelve patients had evaluable pulmonary disease as assessed by CT scan.|||Participants|||Count of Participants
2553524|NCT02774798|Secondary|Hysteresis|"measured as % - the percentage energy dissipated during opening and closing of the anal canal at rest"|at specific time point of measurement up to 1 hour||||percent||Standard Deviation|Mean
2549073|NCT02859454|Primary|Number of Patients With Laryngotracheal Recurrent Respiratory Papillomatosis (RPP) Who Achieve a Complete Response With Avelumab as Measured by Derkay Score Calculated From Clinical Endoscopy|The Derkay is an objective score based on the number of sites and bulkiness of papillomas within the pharynx, larynx and trachea and a subjective score determined by voice and treating symptoms. Complete response is assessed by The Derkay Staging System which is defined as a physical exam and/or clinic-based flexible nasopharyngolaryngoscopy and/or tracheoscopy, exam under anesthesia with endoscopy and biopsies; no evidence of papillomas on physical exam and/or clinic based flexible nasopharyngolaryngoscopy and/or tracheoscopy; and no evidence of papillomas by exam under anesthesia (sedation or general anesthesia) with endoscopy and biopsies.|Disease response was performed at 6 and 12 weeks after the first dose of Avelumab. Patients who experience a complete response will be evaluated every 6 weeks x 3, then every 12 weeks x 3, then every 26 weeks x 2 or until disease progression,up to 3 years|Nine of twelve patients had evaluable laryngotracheal disease as assessed by clinical endoscopy.|||Participants|||Count of Participants
2549074|NCT02859246|Secondary|Change in OSDI Score|"Change was calculated as the value after receiving treatment with guaifenesin for 4 weeks minus the value at baseline.~Total score ranges from 0-100. Lower OSDI scores means subjects are experiencing low ocular discomfort. High OSDI scores means subjects are experiencing high ocular discomfort."|baseline (day 1) and week 4||||score on a scale||Standard Deviation|Mean
2549075|NCT02859246|Primary|Change in Number of Corneal Filaments|Change was calculated as the value after receiving treatment with guaifenesin for 4 weeks minus the value at baseline.|baseline (day 1) and week 4||||corneal filaments||Standard Deviation|Mean
2549076|NCT02858713|Secondary|Lattice-System Physician's Global Assessment (LS-PGA)|"Change from baseline to week 4, 8 and 26~Lattice System Physican's Gloabal Assessment (LS-PGA) is a measure from 0-8 (0, patients skin clear; 8, patients' skin severely affected by psoriasis). The scale is a summary of three subscales: 1). thickness of psoriasis, 2). extent of scaling and 3). body surface ares (BSA) affected. The minimum score is 0 and the maximum score is 8, a high score represents a worse outcome."|Week 4, 8 and 26|Lost to follow-up|||units on a scale||95% Confidence Interval|Mean
2549077|NCT02858713|Secondary|Dermatology Life Quality Index (DLQI)|"Change from baseline to week 4~Description of Dermatology Life Quality Index (DLQI): A score from 0-30 [0, patients' quality of life not affected; 30, patients' quality of life severely affected by the skin disease]. The DLQI-scale is a summary of 10 questions on subscales, where patients' report how severely their quality of life has been affected for the last week (patient reported outcome measurements (PROM), each subscale have a score from 0 (not affected by skin disease) to 3 (severely affected by skin disease).~The minimum score is 0 and the highest score is 30, a high score means worse outcome."|Baseline, week 4, 8 and 26|Patients lost to follow-up|||units on a scale||95% Confidence Interval|Mean
2549078|NCT02858713|Primary|Percentage of Adherent Participants|Rate of adherent patients, defined as dichotomized adherence rates obtained by number of days with applied medication with a selected cut-off of 80%, with adherence rates above 80% considered adherent|Week 4||||percentage of participants||95% Confidence Interval|Number
2549079|NCT02858492|Other Pre-specified|Change From Baseline in Enhancing Volume|Enhancing volume was planned to be measured by DCE-MRI in most affected hand/wrist at indicated time points.|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. This was an other pre-specified outcome measure. Data will not be analyzed and reported.||||||
2549080|NCT02858492|Other Pre-specified|Change From Baseline in Joint Volume|Joint volume was planned to be measured by DCE-MRI in most affected hand/wrist at indicated time points.|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. This was an other pre-specified outcome measure. Data will not be analyzed and reported.||||||
2549081|NCT02858492|Secondary|Number of Participants Achieving Categorical American College of rheumatology20/50/70 (ACR20/50/70) Response|The ACR score was based on improvement from Baseline in tender joint counts and swollen joint counts. A participant had achieved ACR20 if he experienced >=20 percent improvement from Baseline in Tender Joint count 28 (TJC28) and Swollen Joint Count 28 (SJC28) and a >=20 percent improvement from Baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, C-reactive protein and Health Assessment Questionnaire - Disability Index (HAQ-DI). Similarly, ACR50 and ACR70 are calculated using 50 or 70 percent improvement from baseline respectively. For all visits, if any of the component scores were missing; then those scores were considered as not having met the criteria for improvement.|Day 85|Safety Population|||Participants|||Count of Participants
2549082|NCT02858492|Secondary|Number of Participants Achieving Categorical DAS28-CRP Response Using European League Against Rheumatism [EULAR] Response|DAS28-CRP scores were categorized using EULAR response criteria. Response at a given time point was defined based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to Baseline. The definition of no response, moderate response and good response was as; if current DAS28 <=3.2 and DAS28 decrease from Baseline (>1.2: good response), (>0.6 to <=1.2: moderate response) and (<=0.6: no response); if current DAS28 >3.2 to <=5.1 and DAS28 decrease from Baseline value (>1.2: moderate response), (>0.6 to <=1.2: moderate response) and (<=0.6: no response) and if current DAS28 >5.1 and DAS28 decrease from Baseline value (>1.2: moderate response), (>0.6 to <=1.2: no response) and (<=0.6: no response). If the post-Baseline DAS28-CRP score was missing, then the corresponding EULAR category was set to missing.|Day 85|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Participants|||Count of Participants
2549083|NCT02858492|Secondary|Change From Baseline in Disease Activity Score 28-C-Reactive Protein (DAS28-CRP) Scores|The DAS28-CRP is a composite measure of inflammation in rheumatoid arthritis calculated from the sum of tender joint count 28 (TJC28), swollen joint count (SJC28), CRP and patient global assessment of disease activity (PtGA). The formula used to calculate DAS28 score was 0.56 multiplied by square root of TJC28 plus 0.28 multiplied by square root of SJC28 plus 0.36 log of (CRP plus 1) plus 0.014 multiplied by PtGA plus 0.96. Scores of DAS28-CRP ranged from 0.96 to 9.4 with higher scores indicating greater disease burden. A DAS28-CRP score of <=2.6 suggested remission, <3.2 suggested a low level of disease activity, while a score of >5.1 suggested a high level of disease activity. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose) and Day 85|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2549085|NCT02858492|Secondary|Change From Baseline in Initial Rate of Enhancement (IRE)|Initial Rate of Enhancement (IRE) is a measure of how quickly tissue enhances over 60 seconds following administration of contrast agent. IRE was measured by DCE-MRI in most affected hand/wrist at indicated time points. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimole per second||Standard Deviation|Mean
2549086|NCT02858492|Secondary|Change From Baseline in Fractional Volume of Blood Plasma (Vp)|Fractional volume of blood plasma (Vp) is the fractional volume of blood plasma per unit volume of tissue. Vp was measured by DCE-MRI in most affected hand/wrist at indicated time points. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Ratio of plasma volume to tissue volume||Standard Deviation|Mean
2549087|NCT02858492|Secondary|Change From Baseline in Interstitial Volume (Ve)|Interstitial volume (Ve) is the fractional volume of the extravascular extracellular (EC) space per unit volume tissue within which contrast agent can accumulate. Ve was measured by DCE-MRI in most affected hand/wrist at indicated time points. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Ratio of EC space to tissue volume||Standard Deviation|Mean
2549088|NCT02858492|Secondary|Change From Baseline in Exchange Rate (Ktrans)|Contrast agent volume transfer constant (Ktrans) relates to the exchange of contrast agent between the blood plasma and the tissue extravascular extracellular spaces and reflects blood flow and capillary permeability. Ktrans was measured by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) tracer kinetic modeling in the most affected hand/wrist at indicated time points. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Per minute||Standard Deviation|Mean
2549089|NCT02858492|Secondary|Change From Baseline in Joint Space Narrowing by Modified CARLOS|A total of 20 locations in the hand and wrist were evaluated for CARLOS joint space narrowing/cartilage loss. Individual location scores range from 0 (no cartilage loss or Joint Space Narrowing) to 4 (complete ankylosis) in increments of 0.5 based on the amount of narrowing present in a given joint. The final cartilage loss score was the sum of the individual location scores. The total score from 20 location ranged from 0 to 80, with 0 implying no cartilage loss at any location and 80 implying complete ankylosis. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2549090|NCT02858492|Secondary|Change From Baseline in Joint Space Narrowing by RAMRIQ Scoring System|RAMRIQ joint space narrowing was a quantitative measurement from the bones and synovial capsules of the joints from the most affected (or dominant hand if equally affected). It was calculated as the sum of the individual measurements (in millimeter) for the joints measured. The minimum possible total score is 0 implying complete loss of the joint space. The maximum possible total score will be largest possible joint space. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2549091|NCT02858492|Secondary|Change From Baseline in Joint Space Narrowing by OMERACT-RAMRIS Scoring System|Change from Baseline in joint space narrowing was planned to be assessed by OMERACT-RAMRIS scoring system.|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Data was not collected for this outcome measure, as joint space narrowing is not a part of OMERACT-RAMRIS scoring system. Joint space narrowing was measured by RAMRIQ scoring system and modified CARLOS and is presented in outcome measures 33 and 34, respectively.||||||
2549092|NCT02858492|Secondary|Change From Baseline in Bone Edema by Modified CARLOS|Change from Baseline in bone edema was planned to be assessed by modified CARLOS.|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Data was not collected for this outcome measure, as bone edema is not a part of modified CARLOS. Bone edema was measured by OMERACT-RAMRIS and RAMRIQ scoring system and is presented in outcome measures 29 and 30, respectively.||||||
2549093|NCT02858492|Secondary|Change From Baseline in Bone Edema by RAMRIQ Scoring System|RAMRIQ bone edema (normalised) was a quantitative measurement from the bones and synovial capsules of the joints from the most affected (or dominant hand if equally affected). It was calculated as the sum of the individual measurements of the Volume of bone edema divided by sum of the individual measurements of the bone volume. The total score ranged from 0 to 1, with 0 implying no bone marrow lesions. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2549103|NCT02858492|Secondary|Percent Change From Baseline in Monocyte Chemo Attractant Protein-1 (MCP-1)|MCP-1 is an inflammatory biomarker present in blood. Blood samples were collected at indicated time points for the assessment of MCP-1. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated by 100*[(post-dose value minus Baseline value)/ Baseline value].|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent change||Standard Deviation|Mean
2549094|NCT02858492|Secondary|Change From Baseline in Bone Edema by OMERACT-RAMRIS Scoring System|A total of 25 locations in the hand and wrist were evaluated for RAMRIS bone edema or osteitis. Individual location scores range from 0 (no edema) to 3 (67 to 100 percent involvement of original articular bone) based on the proportion of estimated originally non-eroded bone involved. The final bone edema or osteitis score is the sum of the individual location scores. The total score from the 25 locations ranges from 0 to 75, with 0 implying no bone edema or osteitis and 75 implying 67 to 100 percent involvement of original articular bone. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2549095|NCT02858492|Secondary|Change From Baseline in Synovitis by Modified CARLOS|Change from Baseline in synovitis was planned to be assessed by modified CARLOS.|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Data was not collected for this outcome measure, as synovitis is not a part of modified CARLOS. Synovitis was measured by OMERACT-RAMRIS and RAMRIQ scoring system and is presented in outcome measures 26 and 27, respectively.||||||
2549096|NCT02858492|Secondary|Change From Baseline in Synovitis by RAMRIQ Scoring System|RAMRIQ synovitis (normalised) was a quantitative measurement from the bones and synovial capsules of the joints from the most affected (or dominant hand if equally affected). It was calculated as the sum of the individual measurements of the volume of enhancing pannus (VEP) divided by sum of the individual measurements of the joint volume. The total score ranged from 0 to 1, with 0 implying no synovitis. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2549097|NCT02858492|Secondary|Change From Baseline in Synovitis by OMERACT-RAMRIS Scoring System|A total of 8 joints in the hand and wrist were evaluated for RAMRIS synovitis. Individual joint scores were assessed on a scale of 0 (no synovitis) to 3 (67 to 100 percent volume enhancement). The final synovitis score was the sum of the individual joint scores. The total score from 8 joints ranges from 0 to 24, with 0 implying normal (no synovitis) and 24 implying 67 to 100 percent volume enhancement. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2549098|NCT02858492|Secondary|Change From Baseline in Bone Erosions by Modified Cartilage Loss Scoring System (CARLOS)|Change from Baseline in bone erosions was planned to be assessed by modified CARLOS.|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Data was not collected for this outcome measure, as bone erosion is not a part of modified CARLOS. Bone erosion was measured by OMERACT-RAMRIS and RAMRIQ scoring system and is presented in outcome measures 23 and 24, respectively.||||||
2549099|NCT02858492|Secondary|Change From Baseline in Bone Erosions by the Rheumatoid Arthritis MRI Quantitative (RAMRIQ) Scoring System|RAMRIQ bone erosions (normalized) was a quantitative measurement from the bones and synovial capsules of the joints from the most affected (or dominant hand if equally affected). It was calculated as the sum of the individual measurements of the volume of bone erosions divided by sum of the individual measurements of the bone volume. The total score ranged from 0 to 1, with 0 implying no erosive damage. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2549100|NCT02858492|Secondary|"Change From Baseline in Bone Erosion Total Score by Outcome Measures in Rheumatology, Rheumatoid Arthritis Magnetic Resonance Image Scoring System (OMERACT-RAMRIS) Scoring System"|"A total of 25 locations in the hand and wrist were evaluated for RAMRIS bone erosions. Individual location scores range from 0 (no erosions) to 10 (91 to 100 percent of bone eroded) based on the proportion of eroded bone compared to the assessed bone volume on all available images. The final bone erosion score was the sum of the individual location scores. The total score from the 25 locations ranges from 0 to 250, with 0 implying no bone erosion and 250 implying 91 to 100 percent bone eroded. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value."|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2549101|NCT02858492|Secondary|Percent Change From Baseline in Myeloid-related Protein 8/14 (MRP8/14)|MRP8/14 is an inflammatory biomarker present in blood. Blood samples were collected at indicated time points for the assessment of MRP8/14. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated by 100*[(post-dose value minus Baseline value)/ Baseline value].|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent change||Standard Deviation|Mean
2549102|NCT02858492|Secondary|Percent Change From Baseline in Migration Inhibitory Factor (MIF)|MIF is an inflammatory biomarker present in blood. Blood samples were collected at indicated time points for the assessment of MIF. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated by 100*[(post-dose value minus Baseline value)/ Baseline value].|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent change||Standard Deviation|Mean
2549153|NCT02858401|Secondary|Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 3 on Day 29||PostDose 3 on Day 29|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2549154|NCT02858401|Secondary|Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 2 on Day 15||PostDose 2 on Day 15|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2549104|NCT02858492|Secondary|Percent Change From Baseline in Tissue Inhibitor of Metalloproteinases-1 (TIMP-1)|TIMP-1 is an inflammatory biomarker present in blood. Blood samples were collected at indicated time points for the assessment of TIMP-1. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated by 100*[(post-dose value minus Baseline value)/ Baseline value].|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent change||Standard Deviation|Mean
2549105|NCT02858492|Secondary|Percent Change From Baseline in Matrix Metalloproteinase-1 (MMP-1), MMP-3, and MMP-13|MMP-1, MMP-3, and MMP-13 are an inflammatory biomarkers present in blood. Blood samples were collected at indicated time points for the assessment of MMP-1, MMP-3, and MMP-13. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated by 100*[(post-dose value minus Baseline value)/ Baseline value].|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent change||Standard Deviation|Mean
2549106|NCT02858492|Secondary|Percent Change From Baseline in Interleukin 6 (IL6)|IL6 is an inflammatory biomarker present in blood. Blood samples were collected at indicated time points for the assessment of IL6. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated by 100*[(post-dose value minus Baseline value)/ Baseline value].|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent change||Standard Deviation|Mean
2549107|NCT02858492|Secondary|Percent Change From Baseline in C-Reactive Protein (CRP)|CRP is an inflammatory biomarker present in blood. Blood samples were collected at indicated time points for the assessment of CRP. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated by 100*[(post-dose value minus Baseline value)/ Baseline value].|Baseline (Day 1 pre-dose), Days 43 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent change||Standard Deviation|Mean
2549108|NCT02858492|Secondary|Pre-dose Plasma Concentrations of Methotrexate on Days 1, 8 and 43|Blood samples were collected on Day 1, Day 8 and Day 43 for determining pre-dose plasma concentrations of methotrexate. Pharmacokinetic parameters were determined using standard non-compartmental methods. Only participants who received methotrexate during the study were included.|Pre-dose on Days 1, 8 and 43|Pharmacokinetic Methotrexate Population comprised of participants in the safety population who received an active dose and for whom a methotrexate pharmacokinetic sample was obtained and analyzed. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Nanogram per milliliter||Standard Deviation|Mean
2549109|NCT02858492|Secondary|Trough Plasma Concentration of GSK2982772 on Day 85|Blood samples were collected to evaluate plasma concentration of GSK2982772. Pharmacokinetic parameters including trough plasma concentration was determined using standard non-compartmental methods.|Day 85|Pharmacokinetic GSK298772 Population. Only those participants with data available at the specified data points were analyzed.|||Nanogram per milliliter||Standard Deviation|Mean
2549110|NCT02858492|Secondary|Post-dose Plasma Concentrations of GSK2982772 on Days 1, 8, and 43 at 1, 2, 4 and 6 Hours|Blood samples were collected on Day 1, Day 8 and Day 43 for determining post-dose plasma concentrations of GSK2982772. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Days 1, 8 and 43: 1, 2, 4 and 6 hours post-dose|Pharmacokinetic GSK298772 Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Nanogram per milliliter||Standard Deviation|Mean
2549111|NCT02858492|Secondary|Pre-dose Plasma Concentrations of GSK2982772 on Days 8 and 43|Blood samples were collected on Day 8 and Day 43 for determining pre-dose plasma concentrations of GSK2982772. Pharmacokinetic parameters were determined using standard non-compartmental methods.|Pre-dose on Day 8 and Day 43|Pharmacokinetic GSK298772 Population comprised of participants in the safety population who received an active dose and for whom a GSK2982772 pharmacokinetic sample was obtained and analyzed. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Nanogram per milliliter||Standard Deviation|Mean
2549112|NCT02858492|Primary|Change From Baseline in Vital Sign-heart Rate at Indicated Time Points|Vital sign-heart rate was planned to be assessed as a measure of safety and tolerability.|Baseline (Day 1 pre-dose), Days 8, 15, 29, 43, 57, 71 and 85|The data for assessment of vital sign-heart rate was not collected.||||||
2549113|NCT02858492|Primary|Change From Baseline in Body Temperature at Indicated Time Points|Body temperature was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 8, 15, 29, 43, 57, 71 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Degrees Celsius||Standard Deviation|Mean
2549114|NCT02858492|Primary|Change From Baseline in Respiratory Rate at Indicated Time Points|Respiratory rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 8, 15, 29, 43, 57, 71 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Breaths per minute||Standard Deviation|Mean
2549115|NCT02858492|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points|SBP and DBP were measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 8, 15, 29, 43, 57, 71 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2549116|NCT02858492|Primary|Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points|12- lead ECG was measured on each day using an ECG machine that automatically calculated the heart rate and measured PR interval, QRS duration, QT interval QTcB and QTcF. ECG was measured in semi-supine or supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 8, 15, 29, 43, 57, 71 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millisecond||Standard Deviation|Mean
2549117|NCT02858492|Primary|Change From Baseline in Electrocardiogram (ECG) Heart Rate at Indicated Time Points|12- lead ECG was measured on each day using an ECG machine that automatically calculated the heart rate and measured PR interval, QRS duration, QT interval, QT interval corrected for heart rate according to either Bazett's formula (QTcB) and QT interval corrected for heart rate according to Fridericia's formula (QTcF). ECG was measured in semi-supine or supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.|Baseline (Day 1 pre-dose), Days 8, 15, 29, 43, 57, 71 and 85|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Beats per minute||Standard Deviation|Mean
2549118|NCT02858492|Primary|Number of Participants With Worst Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline by Microscopy Method|Urine samples were collected to assess glucose, ketones, occult blood and protein by dipstick method. Microscopy was performed only on urine samples showing an abnormality on the dipstick. Microscopy was performed for hyaline casts, red blood cells and white blood cells. Results for microscopy parameters hyaline casts, red blood cells and white blood cells were categorized as 'any increase from Baseline', which imply any increase in their count in the urine sample. Only participants with worst case any increase from Baseline values are presented.|Up to Day 112|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2549119|NCT02858492|Primary|Number of Participants With Worst Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method|Urine samples were collected to assess glucose, ketones, occult blood and protein by dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters glucose, ketones, occult blood and protein were categorized as 'any increase from Baseline', which imply any increase in their concentrations in the urine sample. Only participants with worst case any increase from Baseline values are presented.|Up to Day 112|Safety Population|||Participants|||Count of Participants
2549120|NCT02858492|Primary|Number of Participants With Worst Case Hematology Parameters of PCI|Hematology parameters included hematocrit, hemoglobin, lymphocytes, platelet counts, total neutrophils and white blood cells (WBCs). PCI ranges were < 0.075 (decrease from baseline) or >0.54 proportion of red blood cells in blood (high) for hematocrit, <25 (low) or >180 grams per liter (g/L) (high) for hemoglobin, <0.8 x10^9 cells per liter (cells/L) for lymphocytes (low), <100 (low) or >550 x10^9 cells/L(high) for platelets, <1.5 x10^9 cells/L (low) for total neutrophils and < 3 (low) or >20 x10^9 cells/L (high) for WBCs. Participants were counted in the worst case category that their value changes (to low or to high), unless there is no change in their category. Only those hematology parameters with PCI values (to low and to high) have been presented.|Up to Day 112|Safety Population|||Participants|||Count of Participants
2549121|NCT02858492|Primary|Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)|Clinical chemistry parameters included alanine amino transferase (ALT), albumin, alkaline phosphatase, aspartate amino transferase (AST), calcium, creatinine, glucose, potassium, sodium and total bilirubin. PCI ranges were ALT(high): >=2*Upper limit of Normal(ULN) units per liter(U/L), albumin(low): 30 millimoles per liter(mmol/L), alkaline phosphatase(high): >=2*ULN U/L, AST(high): >=2*ULN U/L, calcium: <2(low) or >2.75 mmol/L(high), creatinine (high): increase from Baseline >44.25 mmol/L, glucose: <3(low) or >9 mmol/L(high), potassium: <3(low) or >5.5 mmol/L(high), sodium: <130(low) or >150 mmol/L(high) and total bilirubin(high): >=1.5*ULN micromoles per liter(µmol/L). Participants were counted in the worst case category if their value changes (to low or to high), unless there is no change in their category. Only those clinical chemistry parameters with PCI values (to low and to high) have been presented.|Up to Day 112|Safety Population|||Participants|||Count of Participants
2549122|NCT02858492|Primary|Number of Participants With Non-serious Adverse Events (nSAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability|An AE was any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Number of participants with any nSAE or SAE are presented.|Up to Day 112|Safety Population comprised of all participants who received at least one dose of the study treatment.|||Participants|||Count of Participants
2549123|NCT02858440|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|The SAEs assessed included any untoward medical occurrences that resulted in death, were life threatening, required hospitalisation or prolongation of existing hospitalisation or resulted in disability/incapacity. Any = Occurrence of the AE regardless of the intensity grade.|During the entire study period (i.e. from Day 0 until Month 16)|TVC for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented, and TVC for analysis of safety of the booster epoch: all subjects with the booster vaccine dose administration documented.|||Participants|||Count of Participants
2549124|NCT02858440|Secondary|Number of Subjects With Unsolicited AEs Following Booster Vaccination|An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of the intensity grade.|During the 31-day (Days 0-30) follow-up period after booster vaccination dose (i.e. at Month 15)|Total vaccinated cohort (TVC) for analysis of safety of the booster epoch: all subjects with at least one booster vaccine dose administration documented.|||Participants|||Count of Participants
2549125|NCT02858440|Secondary|Number of Subjects With Unsolicited AEs Following Each Dose of Primary Vaccination|An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of the intensity grade.|During the 31-day (Days 0-30) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)|TVC for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented.|||Participants|||Count of Participants
2549126|NCT02858440|Secondary|Number of Subjects With Any Solicited General AEs Following Booster Vaccination|The solicited general AEs assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any = Occurrence of the AE regardless of the intensity grade. Any fever = Fever (axillary) ≥ 37.5°C.|During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15)|Total vaccinated cohort (TVC) for analysis of safety of the booster epoch: all subjects with at least one booster vaccine dose administration documented.|||Participants|||Count of Participants
2549127|NCT02858440|Secondary|Number of Subjects With Any Solicited General AEs Following Each Dose of Primary Vaccination|The solicited general AEs assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any = Occurrence of the AE regardless of the intensity grade. Any fever = Fever (axillary) ≥ 37.5°C.|During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)|TVC for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented.|||Participants|||Count of Participants
2549128|NCT02858440|Secondary|Number of Subjects With Any Solicited Local AEs Following Booster Vaccination|The solicited local AEs assessed were pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade.|During the 4-day (Days 0-3) follow-up period after booster vaccination dose (i.e. at Month 15)|Total vaccinated cohort (TVC) for analysis of safety of the booster epoch: all subjects with at least one booster vaccine dose administration documented.|||Participants|||Count of Participants
2549129|NCT02858440|Secondary|Number of Subjects With Any Solicited Local Adverse Events (AEs) Following Each Dose of Primary Vaccination|The solicited local AEs assessed were pain, redness and swelling at injection site. Any = Occurrence of the AE regardless of the intensity grade.|During the 4-day (Days 0-3) follow-up period after each primary vaccination dose (i.e. at Day 0, at Month 1.5 and at Month 3)|Total vaccinated cohort (TVC) for analysis of safety of the primary epoch: all subjects with at least one primary vaccine dose administration documented.|||Participants|||Count of Participants
2549130|NCT02858440|Secondary|Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Booster Vaccination|The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL.|At Month 16 (i.e. one month after booster vaccination)|The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.|||IU/mL||95% Confidence Interval|Geometric Mean
2549131|NCT02858440|Secondary|Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN, Post Primary Vaccination|The antibody concentrations for anti-PT, anti-FHA and anti-PRN were presented as GMCs and expressed as IU/mL.|At Month 4 (i.e. one month after 3rd dose of primary vaccination)|The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.|||IU/mL||95% Confidence Interval|Geometric Mean
2549132|NCT02858440|Secondary|Antibody Concentration for Anti-PRP, Post Booster Vaccination|The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL.|At Month 16 (i.e. one month after booster vaccination)|The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.|||µg/mL||95% Confidence Interval|Geometric Mean
2549133|NCT02858440|Secondary|Antibody Concentration for Anti-PRP, Post Primary Vaccination|The antibody concentrations for anti-PRP were presented as geometric mean concentrations (GMCs) and expressed as µg/mL.|At Month 4 (i.e. one month after 3rd dose of primary vaccination)|The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.|||µg/mL||95% Confidence Interval|Geometric Mean
2549134|NCT02858440|Secondary|Antibody Titers for Anti-polio Types 1, 2 and 3, Post Booster Vaccination|The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titres (GMTs).|At Month 16 (i.e. one month after booster vaccination)|The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.|||Titers||95% Confidence Interval|Geometric Mean
2549135|NCT02858440|Secondary|Antibody Titers for Anti-polio Types 1, 2 and 3, Post Primary Vaccination|The antibody titers for anti-polio types 1, 2 and 3 were presented as geometric mean titres (GMTs).|At Month 4 (i.e. one month after 3rd dose of primary vaccination)|The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.|||Titers||95% Confidence Interval|Geometric Mean
2549136|NCT02858440|Secondary|Antibody Concentrations for Anti-D and Anti-T, Post Booster Vaccination|The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL.|At Month 16 (i.e. one month after booster vaccination)|The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.|||IU/mL||95% Confidence Interval|Geometric Mean
2549155|NCT02858401|Secondary|Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at Postdose 1 on Day 1||Postdose 1 on Day 1|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2549137|NCT02858440|Secondary|Antibody Concentrations for Anti-D and Anti-T, Post Primary Vaccination|The antibody concentrations for anti-D and anti-T were presented as geometric mean concentrations (GMCs) and expressed as IU/mL.|At Month 4 (i.e. one month after 3rd dose of primary vaccination)|The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.|||IU/mL||95% Confidence Interval|Geometric Mean
2549138|NCT02858440|Secondary|Number of Seropositive Subjects for Anti- PT, Anti-FHA and Anti-PRN, Post Booster Vaccination|A seropositive subject is a subject whose antibody concentration was ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT.|At Month 16 (i.e. one month after booster vaccination)|The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.|||Participants|||Count of Participants
2549139|NCT02858440|Secondary|Number of Seroprotected Subjects for Anti-PRP, Post Booster Vaccination|A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 µg/mL.|At Month 16 (i.e. one month after booster vaccination)|The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.|||Participants|||Count of Participants
2549140|NCT02858440|Secondary|Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Booster Vaccination|A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was ≥ 8 ED50.|At Month 16 (i.e. one month after booster vaccination)|The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.|||Participants|||Count of Participants
2549141|NCT02858440|Secondary|Number of Seroprotected Subjects for Anti-D and Anti-T, Post Booster Vaccination|A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was ≥ 0.1 IU/mL.|At Month 16 (i.e. one month after booster vaccination)|The ATP cohort for analysis of immunogenicity of the booster epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after the booster dose.|||Participants|||Count of Participants
2549142|NCT02858440|Primary|Number of Seropositive Subjects for Anti-pertussis (Anti- PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN), Post Primary Vaccination|A seropositive subject is a subject whose antibody concentration was ≥ 2.046 IU/mL for anti-FHA, ≥ 2.187 IU/mL for anti-PRN and ≥ 2.693 IU/mL for anti-PT.|At Month 4 (i.e. one month after 3rd dose of primary vaccination)|The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.|||Participants|||Count of Participants
2549143|NCT02858440|Primary|Number of Seroprotected Subjects for Anti-polyribosyl Ribitol Phosphate (Anti-PRP), Post Primary Vaccination|A seroprotected subject is a subject whose anti-PRP antibody concentration was ≥ 0.15 micrograms per milliliter (µg/mL).|At Month 4 (i.e. one month after 3rd dose of primary vaccination)|The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.|||Participants|||Count of Participants
2549144|NCT02858440|Primary|Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3, Post Primary Vaccination|A seroprotected subject is a subject whose anti-poliovirus types 1, 2 and 3 antibody titer was ≥ 8 ED50.|At Month 4 (i.e. one month after 3rd dose of primary vaccination)|The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.|||Participants|||Count of Participants
2549145|NCT02858440|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T), Post Primary Vaccination|A seroprotected subject is a subject whose anti-D and anti-T antibody concentration was greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL).|At Month 4 (i.e. one month after 3rd dose of primary vaccination)|The According-to-protocol (ATP) cohort for analysis of immunogenicity of the primary epoch included all evaluable subjects who complied with protocol and for whom assay results were available for antibodies against at least one study vaccine antigen component one month after Dose 3.|||Participants|||Count of Participants
2549146|NCT02858401|Secondary|Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 10 on Day 127||PostDose 10 on Day 127|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2549147|NCT02858401|Secondary|Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 9 on Day 113||PostDose 9 on Day 113|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2549148|NCT02858401|Secondary|Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 8 on Day 99||PostDose 8 on Day 99|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2549149|NCT02858401|Secondary|Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 7 on Day 85||PostDose 7 on Day 85|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2549150|NCT02858401|Secondary|Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 6 on Day 71||PostDose 6 on Day 71|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2549151|NCT02858401|Secondary|Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 5 on Day 57||PostDose 5 on Day 57|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2549152|NCT02858401|Secondary|Percentage of Participants With Plasma HIV-1 RNA ≥ 50 Copies/mL at PostDose 4 on Day 43||PostDose 4 on Day 43|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2549156|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 157|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 157.|Baseline; Day 157|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549157|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 134|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 134.|Baseline; Day 134|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549158|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 129|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 129.|Baseline; Day 129|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549159|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 128|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 128.|Baseline; Day 128|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549160|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 127|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 127.|Baseline; Day 127|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549161|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 120|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 120.|Baseline; Day 120|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549162|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 115|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 115.|Baseline; Day 115|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549163|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 113|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 113.|Baseline; Day 113|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549164|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 106|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 106.|Baseline; Day 106|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549165|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 101|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 101.|Baseline; Day 101|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549166|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 99|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 99.|Baseline; Day 99|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549167|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 92|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 92.|Baseline; Day 92|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549168|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 87|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 87.|Baseline; Day 87|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549169|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 85|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 85.|Baseline; Day 85|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549170|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 81|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 81.|Baseline; Day 81|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549171|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 78|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 78.|Baseline; Day 78|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549172|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 75|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 75.|Baseline; Day 75|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549173|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 73|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 73.|Baseline; Day 73|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549174|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 71|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 71.|Baseline; Day 71|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549175|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 67|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 67.|Baseline; Day 67|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549176|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 64|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 64.|Baseline; Day 64|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549177|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 61|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 61.|Baseline; Day 61|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549178|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 59|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 59.|Baseline; Day 59|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549179|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 58|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 58.|Baseline; Day 58|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549180|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 57|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 57.|Baseline; Day 57|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549181|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 53|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 53|Baseline; Day 53|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549182|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 50|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 50.|Baseline; Day 50|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549183|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 47|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 47|Baseline; Day 47|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549184|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 45|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit pn Day 45|Baseline; Day 45|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549185|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 43|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 43|Baseline; Day 43|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549186|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 39|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 39|Baseline; Day 39|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549187|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 36|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 36|Baseline; Day 36|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549188|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 33|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 33.|Baseline; Day 33|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549189|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 31|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 31.|Baseline; Day 31|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549190|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 29|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 29.|Baseline; Day 29|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549191|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 25|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 25.|Baseline; Day 25|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549192|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 22|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 22.|Baseline; Day 22|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549193|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 19|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 19.|Baseline; Day 19|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549194|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 17|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 17.|Baseline; Day 17|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549195|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 15|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 15.|Baseline; Day 15|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549196|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 11|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 11.|Baseline; Day 11|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549197|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 8|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 8.|Baseline; Day 8|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549198|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 5|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 5.|Baseline; Day 5|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549199|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 3|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 3.|Baseline; Day 3|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549200|NCT02858401|Secondary|Change From Baseline in Plasma Log10 HIV-1 RNA at Day 2|Change from baseline in plasma log10 HIV-1 RNA refers to change from baseline at a postbaseline visit on Day 2.|Baseline; Day 2|Participants in the Full Analysis Set with available data were analyzed.|||Log10 copies/mL||Standard Deviation|Mean
2549201|NCT02858401|Primary|Maximum Change From Baseline in Plasma Log10 HIV-1 RNA at Any Postdose Timepoint|The maximum change from baseline in plasma Log10 HIV-1 RNA refers to the maximum change at any postdose timepoint up to Day 81 or Day 134 for placebo, Day 81 for Cohorts 1 to 3, and Day 134 for Cohorts 4 to 6.|For Cohorts 1 to 3: Baseline to Day 81; For Cohorts 4 to 6: Baseline to Day 134; For placebo: Baseline to Day 81 or Baseline to Day 134|The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.|||Log10 copies/mL||Standard Error|Mean
2549202|NCT02858401|Primary|Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs) and Any Treatment-Emergent Adverse Events (AEs).||For Cohorts 1 to 3: First dose date up to 71 days plus 30 days; For Cohorts 4 to 6: First dose date up to 127 days plus 30 days; For placebo: First dose date up to 71 days plus 30 days or first dose date up to 127 days plus 30 days|The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2549203|NCT02858362|Secondary|Number of Participants That Experienced a Clinically Significant Coagulation Result (Investigator's Assessment)|Parameters included: activated partial thromboplastin time, prothrombin time and international normalised ratio. Coagulation was only assessed for Cohorts 2 and 3. Results for Cohorts 2 and 3 are pooled as specified in the protocol.|Day 1 to Week 48|All participants who received at least one dose of study medication in Cohorts 2 and 3 only.|||Participants|||Count of Participants
2549204|NCT02858362|Secondary|Number of Participants That Experienced a Clinically Significant Urinalysis Result (Investigator's Assessment)|Parameters included: glucose, bilirubin, ketones, specific gravity, blood, pH, protein, urobilinogen, nitrites and leucocytes. Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol.|Day 1 to Week 48|All participants who received at least one dose of study medication.|||Participants|||Count of Participants
2549205|NCT02858362|Secondary|Number of Participants That Experienced a Potentially Clinically Significant Liver Function Result|Laboratory measurements for alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TB), alkaline phosphatase (ALP), and glutamate dehydrogenase (GLDH). Hy's Law is defined as an increase in ALT, AST and TB, indicating hepatocyte necrosis and functional deficit. Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol.|Baseline to Week 48|All participants who received at least one dose of study medication.|||Participants|||Count of Participants
2549206|NCT02858362|Secondary|Number of Participants Who Experienced a Clinically Significant Biochemistry Result (Investigator's Assessment)|Parameters included: calcium, potassium, sodium, albumin, urea nitrogen, uric acid, creatinine, creatine kinase, fasting glucose, cystatin C, lactate dehydrogenase, amylase, lipase, low density lipoprotein cholesterol, high density lipoprotein (HDL) cholesterol, cholesterol, non-HDL cholesterol, total HDL cholesterol ratio, total bilirubin, direct bilirubin, indirect bilirubin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase and glutamate dehydrogenase. Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol.|Day 1 to Week 48|All participants who received at least one dose of study medication.|||Participants|||Count of Participants
2549207|NCT02858362|Secondary|Number of Participants That Experienced a Clinically Significant Haematology Result (Investigator's Assessment)|Parameters included: haemoglobin, haematocrit, mean corpuscular volume, white blood cells, red blood cells, neutrophils (percentage and absolute), lymphocytes (percentage and absolute), monocytes (percentage and absolute), eosinophils (percentage and absolute), basophils (percentage and absolute) and platelets. Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol.|Day 1 to Week 48|All participants who received at least one dose of study medication.|||Participants|||Count of Participants
2549208|NCT02858362|Secondary|Number of Participants That Experienced a Potentially Clinically Significant Echocardiogram Measurement|Participants were at rest in a supine position for 10 minutes before the measurements were performed. Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol.|Baseline, Week 24 and Week 48|All participants who received at least one dose of study medication. No evaluable data was collected from Cohort 3 participants due to early study termination.|||Participants|||Count of Participants
2549209|NCT02858362|Secondary|Number of Participants That Experienced a Potentially Clinically Significant Electrocardiogram Measurements|PR interval (PRI), heart rate (HR), QTcF and increase from baseline in QTcF (IQTcF) were summarized categorically. Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol.|Baseline to Week 48|All participants who received at least one dose of study medication. No evaluable data was collected from Cohort 3 participants due to early study termination.|||Participants|||Count of Participants
2549210|NCT02858362|Secondary|Number of Participants That Experienced a Clinically Significant in Physical Examination Result|Examinations included: ear, nose and throat, cardiovascular system, pulmonary system, skin, abdomen, neurological system, height and weight. Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol.|Day 1 to Week 48|All participants who received at least one dose of study medication.|||Participants|||Count of Participants
2549211|NCT02858362|Secondary|Number of Participants That Experienced a Clinically Significant Change in Vital Signs Measurements|"Systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse will be disclosed with the following categories:~All values within 20% of change from baseline (< 20% change).~At least one value ≥ 20% reduction from baseline, but no increases ≥ 20% from baseline (≥ 20% reduction and no < 20% increase).~At least one value ≥ 20% increase from baseline, but no reductions ≥ 20% from baseline (≥ 20% Increase and no < 20% reduction).~At least one value ≥ 20% reduction from baseline and at least one value ≥ 20% increase from baseline (≥ 20% reduction and ≥ 20% increase).~Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol."|Baseline to Week 48|All participants who received at least one dose of study medication. No evaluable data was collected from Cohort 3 participants due to early study termination.|||Participants|||Count of Participants
2549212|NCT02858362|Secondary|Change From Baseline in Sniff Nasal Inspiratory Pressure (SNIP)|Analysis of SNIP was planned for Cohort 3 only.|Baseline, Week 12, Week 24, Week 36 and Week 48|No evaluable data was collected from Cohort 3 participants due to early study termination.||||||
2549214|NCT02858362|Secondary|Change From Baseline in Peak Expiratory Flow (PEF)|Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol.|Baseline, Week 12, Week 24, Week 36 and Week 48|All participants who received at least one dose of study medication. No evaluable data was collected from Cohort 3 participants due to early study termination.|||Percentage of PEF||Standard Deviation|Mean
2549215|NCT02858362|Secondary|Change From Baseline in Maximum Expiratory Pressure (MEP)|Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol.|Baseline, Week 12, Week 24, Week 36 and Week 48|All participants who received at least one dose of study medication. No evaluable data was collected from Cohort 3 participants due to early study termination.|||cm H2O||Standard Deviation|Mean
2549216|NCT02858362|Secondary|Change From Baseline in Maximum Inspiratory Pressure (MIP)|Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol.|Baseline, Week 12, Week 24, Week 36 and Week 48|All participants who received at least one dose of study medication. No evaluable data was collected from Cohort 3 participants due to early study termination.|||cm H2O||Standard Deviation|Mean
2549217|NCT02858362|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol.|Baseline, Week 12, Week 24, Week 36 and Week 48|All participants who received at least one dose of study medication. No evaluable data was collected from Cohort 3 participants due to early study termination.|||Percentage of FVC||Standard Deviation|Mean
2549218|NCT02858362|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|Results for Cohorts 1, 2 and 3 are pooled as specified in the protocol.|Baseline, Week 12, Week 24, Week 36 and Week 48|All participants who received at least one dose of study medication. No evaluable data was collected from Cohort 3 participants due to early study termination.|||Percentage of FEV1||Standard Deviation|Mean
2549219|NCT02858362|Secondary|Change From Baseline in Muscle Fibre Diameter|A maximum of two muscle biopsies were taken, one at baseline and the other at Week 24 or Week 48. Muscle fibre diameter was analyzed using a semiautomated quantitative assay on the biopsy samples. The endpoint was measured for Cohorts 1 and 2 only. Results for Cohorts 1 and 2 are pooled as specified in the protocol.|Baseline, Week 24 and Week 48|All participants who received at least one dose of study medication and had at least one assessment of the endpoint (which could be their baseline assessment). For the summaries of changes from baseline only those participants in this population who had measurements at both baseline and the relevant post-baseline visit were included.|||Micrometers (μm)||Standard Deviation|Mean
2549220|NCT02858362|Secondary|Change From Baseline in Developmental Heavy Chain Myosin (MHCd) Expression|A maximum of two muscle biopsies were taken, one at baseline and the other at Week 24 or Week 48. MHCd expression was analyzed using a semiautomated quantitative assay on the biopsy samples. A positive change from baseline represents an increase in MHCd expression, no change from baseline represents maintenance of MHCd expression and a negative change from baseline represents a reduction in MHCd expression. The endpoint was measured for Cohorts 1 and 2 only. Results for Cohorts 1 and 2 are pooled as specified in the protocol.|Baseline, Week 24 and Week 48|All participants who received at least one dose of study medication and had at least one assessment of the endpoint (which could be their baseline assessment). For the summaries of changes from baseline only those participants in this population who had measurements at both baseline and the relevant post-baseline visit were included.|||Percent of muscle fibres expressing MHCd||Standard Deviation|Mean
2549221|NCT02858362|Secondary|Change From Baseline in Utrophin Intensity|A maximum of two muscle biopsies were taken, one at baseline and the other at Week 24 or Week 48. Utrophin intensity was analyzed using a semiautomated quantitative assay on the biopsy samples. A positive change from baseline represents an increase in utrophin expression, no change from baseline represents maintenance of utrophin expression and a negative change from baseline represents a reduction in utrophin expression. The endpoint was measured for Cohorts 1 and 2 only. Results for Cohorts 1 and 2 are pooled as specified in the protocol.|Baseline, Week 24 and Week 48|All participants who received at least one dose of study medication and had at least one assessment of the endpoint (which could be their baseline assessment). For the summaries of changes from baseline only those participants in this population who had measurements at both baseline and the relevant post-baseline visit were included.|||Arbitrary units||Standard Deviation|Mean
2549222|NCT02858362|Primary|Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs)|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A TEAE is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug.|Day 1 to a maximum of Week 96|All participants who received at least one dose of study medication.|||Participants|||Count of Participants
2549223|NCT02858362|Primary|Simulated Average Plasma Concentration (Cav) for SMT C1100, Dihydrodiol 1 (DHD1) and Dihydrodiol III (DHD 3)|Pharmacokinetic analysis is presented by cohort due to the use of different formulations.|Pre-dose and 3 to 10 hours post-dose at Weeks 1, 4, 8, 12, 24, 36 and 48|All participants in Cohorts 1 or 2 who received at least one dose of study medication and had at least one concentration measurement (which could be below the limit of quantification). No evaluable data was collected from Cohort 3 participants due to early study termination.|||ng/mL||Full Range|Geometric Mean
2549224|NCT02858362|Primary|Simulated Maximum Plasma Concentration (Cmax) for SMT C1100, Dihydrodiol 1 (DHD1) and Dihydrodiol III (DHD 3)|Pharmacokinetic analysis is presented by cohort due to the use of different formulations.|Pre-dose and 3 to 10 hours post-dose at Weeks 1, 4, 8, 12, 24, 36 and 48|All participants in Cohorts 1 or 2 who received at least one dose of study medication and had at least one concentration measurement (which could be below the limit of quantification). No evaluable data was collected from Cohort 3 participants due to early study termination.|||ng/mL||Full Range|Geometric Mean
2549225|NCT02858362|Primary|Observed Trough Plasma Concentration (Ctrough) for SMT C1100, Dihydrodiol 1 (DHD1) and Dihydrodiol III (DHD 3)|Pharmacokinetic analysis is presented by cohort due to the use of different formulations. The median pre-dose concentration was derived for each participant and then summarized across participants.|Pre-dose at Weeks 1, 4, 8, 12, 24, 36 and 48|All participants in Cohorts 1 or 2 who received at least one dose of study medication and had at least one concentration measurement (which could be below the limit of quantification). No evaluable data was collected from Cohort 3 participants due to early study termination.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2549226|NCT02858362|Primary|Change From Baseline for Magnetic Resonance Spectroscopy (MRS) Water Transverse Relaxation Time (WTRT) for Leg Muscles|MRS WTRT was analysed for the vastus lateralis and soleus leg muscles. The endpoints were measured for Cohorts 1 and 2 only. Results for Cohorts 1 and 2 are pooled as specified in the protocol.|Baseline, Week 12, Week 24, Week 36 and Week 48|All participants who received at least one dose of study medication and had at least one assessment of the endpoint (which could be their baseline assessment).|||Milliseconds||95% Confidence Interval|Mean
2549227|NCT02858362|Primary|Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Fat Fraction (FF) for Leg Muscles|MRS FF was analysed for vastus lateralis and soleus leg muscles. The endpoints were measured for Cohorts 1 and 2 only. Results for Cohorts 1 and 2 are pooled as specified in the protocol.|Baseline, Week 12, Week 24, Week 36 and Week 48|All participants who received at least one dose of study medication and had at least one assessment of the endpoint (which could be their baseline assessment).|||Percentage of fat in the muscle||95% Confidence Interval|Mean
2549228|NCT02858349|Secondary|Walking Speed|10-meter walk test|baseline, 4 weeks, 8 weeks|||||||
2549229|NCT02858349|Secondary|Daily Walking Activity|activity monitor|baseline, 4 weeks, 8 weeks|||||||
2549230|NCT02858349|Secondary|Walking Capacity|6-minute walk test|baseline, 4 weeks, 8 weeks|||||||
2549231|NCT02858349|Secondary|Brain Locomotor Network Connectivity||baseline, 4 weeks, 8 weeks|||||||
2549232|NCT02858349|Secondary|Brain Locomotor Network Activation||baseline, 4 weeks, 8 weeks|||||||
2549233|NCT02858349|Secondary|Stroke and Aphasia Quality of Life Scale||baseline, 4 weeks, 8 weeks|||||||
2549234|NCT02858349|Secondary|NIH Toolbox Standing Balance Test||baseline, 4 weeks, 8 weeks|||||||
2549235|NCT02858349|Secondary|NIH Toolbox - Cognition Domain||baseline, 4 weeks, 8 weeks|||||||
2549236|NCT02858349|Secondary|Aerobic Capacity|oxygen consumption rate during exercise testing|baseline, 4 weeks, 8 weeks|||||||
2549237|NCT02858349|Secondary|Metabolic Cost of Gait|oxygen consumption rate during comfortable speed gait|baseline, 4 weeks, 8 weeks|||||||
2549238|NCT02858349|Secondary|Gait Symmetry|Paretic step ratio|baseline, 4 weeks, 8 weeks|||||||
2549239|NCT02858349|Primary|Walking Speed|10-meter walk test|Change from 4-weeks to 8-weeks||||meters per second||95% Confidence Interval|Least Squares Mean
2549240|NCT02858180|Other Pre-specified|Discontinuation for Adverse Events and Serious Adverse Events|Assessment for discontinuation due to adverse events and serious adverse events, as addressed by adverse events and laboratory tests. Final study visit is 12 weeks after treatment.|12 weeks after completing treatment||||Participants|||Count of Participants
2549241|NCT02858180|Secondary|Number of Subjects With Sustained Virologic Response (SVR) 4|The secondary outcome of efficacy will be determined by the number of subjects with hepatitis c virus ribonucleic acid (HCV RNA) below a measurable laboratory limit, 4 weeks after completing treatment.|4 weeks after completing treatment||||Participants|||Count of Participants
2549242|NCT02858180|Secondary|Number of Subjects With Sustained Virologic Response (SVR) 12|The secondary outcome of efficacy will be determined by the number of subjects with hepatitis c virus ribonucleic acid (HCV RNA) below a measurable laboratory limit, 12 weeks after completing therapy.|12 weeks after completing treatment||||Participants|||Count of Participants
2549243|NCT02858180|Primary|Number of Subjects Who Completed 24 Weeks of Therapy|The primary safety endpoint is the number of subjects who complete a full course of therapy.|24 weeks||||Participants|||Count of Participants
2549244|NCT02858050|Primary|Use of Portal724-MEMS Service on Medication Adherence in the Treatment of Hepatitis C in Patients, Defined as Compliance to Regimen 95% of the Time.|Number of Participants with Compliance to Regimen 95% of the Time Due to Portal724-MEMS Service|1 year||||Participants|||Count of Participants
2549245|NCT02857816|Secondary|Change in Overactive Bladder Symptom Quality of Life Questionnaire (OABq) After 12th PTNM Therapy Sessions From Baseline|"This objective was to assess the change after12 PTNM therapy sessions from baseline in quality of life as measured by the OABq Questionnaire.~OABq consists of a symptom bother scale and four health related quality of life (HRQL) subscales (Coping, Concern, Sleep and Social interaction). The symptom bother scale and 4 HRQL subscales are measured as 0-100 using a range percentile transformation on the summed value from individual listed items. The HRQL score is a calculated score with a range from 0 to 100 using a range percentile transformation on the summed value from 4 subscales (Coping, Concern, Sleep and Social). A change was calculated as the score after 12th PTNM minus the score at baseline. A positive change in HRQL and its subscales (Coping, Concern, Sleep and Social) indicates improvement in QOL; a negative change in symptom bother score indicates improvement in QOL."|12 Weeks|This objective was assessed in all qualified subjects who received PTNM therapy and had OABq questionnaire data available at both baseline and 12th PTNM session.|||score on a scale||Standard Deviation|Mean
2549246|NCT02857816|Secondary|Change in Number of Voids Per Day After the 12th PTNM Therapy Sessions From Baseline in UF Subjects|Number of voids were collected at baseline and following the 12th PTNM therapy session. For each UF subject in the analysis, a change in number of voids per day was calculated as number of voids per day after 12th PTNM session minus baseline. A negative change indicates improvement in UF symptoms.|12 Weeks|This objective was assessed in qualified subjects with > 8 voids per day at baseline, who had diary data at both baseline and following the 12th PTNM session.|||Number of voids per day||Standard Deviation|Mean
2549247|NCT02857816|Primary|Change in Number of Urinary Urge Incontinence (UUI) Episodes Per Day After the 12th PTNM Therapy Sessions From Baseline|Number of UUI episodes were collected at baseline and following the 12th PTNM therapy session. For each subject in the analysis, change in UUI episodes per day was calculated as UUI episodes per day after 12th PTNM session minus baseline. A negative change indicates the improvement in UUI symptom.|12 Weeks|Subjects with diary data from both baseline and the 12th PTNM therapy session|||UUI episodes per day||Standard Deviation|Mean
2549248|NCT02857283|Secondary|Change in Heart Rate Variability|Measure was not performed as the equipment (ECG leads and monitor recording heart rate and rhythm) belonged to the EPA and was not made available for this study|baseline, immediately post exposure|No participants analyzed as equipment belonging to the EPA was not available||||||
2552249|NCT02797522|Primary|Pharmacokinetics of ARC-521 Injection: Area Under the Plasma-Concentration-Time Curve From Time 0-24 Hours (AUC0-24), Healthy Volunteers||Through 48 hours post-dose on Day 1|Analysis was not planned or conducted per statistical analysis plan (SAP) due to study termination.||||||
2549249|NCT02857283|Secondary|Flow Mediated Dilation (FMD): Change Immediately Post-Exposure From Baseline|Participants will undergo assesment of flow-mediated brachial artery dilation by brachial ultrasound at baseline prior to exposure (within two weeks), and immediately after exposure to either FA or O3 to assess the impact of O3 exposure on endothelial function. Flow mediated dilation of the brachial artery (FMD) is a noninvasive index of vascular endothelial function. FMD is measured using high-frequency ultrasound, and is expressed as the percent change in arterial diameter in response to the reactive hyperemia induced by 5 minutes of forearm ischemia. Impaired endothelial function leads to atherosclerosis and is associated with an increased risk of cardiovascular events.|Baseline and immediately post-exposure|All participants that completed the study|||percent change||Standard Error|Mean
2549250|NCT02857283|Secondary|Nasal Epithelial Cell Inflammatory Cytokine Gene Expression: : Change Immediately Post-Exposure From Screening Visit|RNA isolated from nasal epithelial cell biopsies collected at the screening visit within six weeks prior to the first exposure and immediately after each exposure. RNA will be analyzed via real-time quantitative polymerase chain reaction (qPCR) to determine the impact of O3 on inflammatory gene expression. Gene expression has not yet been analyzed as of March 31, 2020 as it has been delayed by shutdown of the university laboratories due to the pandemic, and will be not be performed until after the reopening of the university.|Screening visit and immediately post-exposure||2020-09-30|09/2020||||
2549251|NCT02857283|Secondary|Left Ventricular Strain (LVS): Change Immediately Post-Exposure From Baseline|Left ventricular strain will be assessed at baseline prior to exposure (within two weeks), and immediately after the exposure by measuring global longitudinal strain (GLS), an echocardiographic measure of myocardial mechanics. GLS is measured using speckle tracking, a technique by which small myocardial footprints, or speckles, are tracked over the cardiac cycle to enable quantification of left ventricular systolic function. GLS is more sensitive than traditional measures of ventricular function, such as ejection fraction, in detecting clinically inapparent but prognostically important decrements in contractility. The change in global longitudinal strain will be calculated to determine the effect of ozone on left ventricular strain.|Baseline and immediately post-exposure|13 of 14 participants who completed the study. Data for one participant has been collected although not analyzed as of 3/31/2020, due to shutdown of university laboratories in response to the pandemic|||percent change||Standard Error|Mean
2549252|NCT02857283|Secondary|Interleukin-8 (IL-8) Concentrations in Nasal Epithelial Lining Fluid (ELF): Change 24 Hours Post-Exposure From Baseline|"Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Nasal epithelial lining (ELF) will be collected from participants at baseline within two weeks prior to first exposure, and at the following time points for each exposure: immediately after exiting the exposure chamber, and at 24 hours after the exposure.~The IL-8 concentration will be determined in each ELF sample by immunoassay. The change in IL-8 concentrations from baseline to 24 hours Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3 to determine the effect of ozone on the production of nasal IL-8."|Baseline, 24 hours post-exposure|All participants that completed the study|||pg/mL||Standard Error|Mean
2549253|NCT02857283|Secondary|Interleukin-8 (IL-8) Concentrations in Nasal Epithelial Lining Fluid (ELF): Change Immediately Post-Exposure From Baseline|"Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Nasal epithelial lining (ELF) will be collected from participants at baseline within two weeks prior to first exposure, and at the following time points for each exposure: immediately after exiting the exposure chamber, and at 24 hours after the exposure.~The IL-8 concentration will be determined in each ELF sample by immunoassay. The change in IL-8 concentrations from baseline to immediately Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3 to determine the effect of ozone on the production of nasal IL-8."|Baseline, immediately post-exposure|All participants that completed the study|||pg/mL||Standard Error|Mean
2549254|NCT02857283|Secondary|Interleukin-6 (IL-6) Concentrations in Nasal Epithelial Lining Fluid (ELF): Change 24 Hours Post-Exposure From Baseline|"Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Nasal epithelial lining (ELF) will be collected from participants at baseline within two weeks prior to first exposure, and at the following time points for each exposure: immediately after exiting the exposure chamber, and at 24 hours after the exposure.~The IL-6 concentration will be determined in each ELF sample by immunoassay. The change in IL-6 concentrations from baseline to 24 hours Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3 to determine the effect of ozone on the production of nasal IL-6."|Baseline, 24 hours post-exposure|All participants that completed the study|||pg/ml||Standard Error|Mean
2549255|NCT02857283|Secondary|The Percentage of Predicted Forced Expiratory Volume in One Second (% Predicted FEV1): Change Immediately Post-Exposure From Baseline|"Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Standard spirometry to obtain FEV1 and forced vital capacity (FVC) measurements will be done at baseline within two weeks prior to first exposure, and immediately after exiting the exposure chamber for each exposure.~The % Predicted FEV1 will be calculated from measured versus expected values. The change in % Predicted FEV1 from baseline to immediately Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3 to determine the effect of ozone on the % Predicted FEV1."|Baseline, immediately post-exposure|All subjects that completed the study|||percent FEV1||Standard Error|Mean
2549256|NCT02857283|Secondary|% Polymorphonuclear Leukocytes (PMN) in Induced Sputum: Change 24 Hours Post-Exposure From Screening Visit|"Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Induced sputum will be collected from participants after inhaled hypertonic saline. Induced sputum will be collected at the screening visit within six weeks prior to the first exposure, and at 24 hours after each exposure.~The % PMN as a percentage of total inflammatory cells (total of monocytes and macrophages, PMN, eosinophils, basophils, lymphocytes, and bronchial epithelial cells) will be determined in each induced sputum collection by differential counts of cells on cytospin slides. The change in the values from baseline to 24 hours Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3."|Screening visit and 24 hours post-exposure|Subjects who produced induced sputum containing at least 60000 inflammatory cells at both the screening visit and at 24 hours after at least one exposure|||percent PMN||Standard Error|Mean
2552277|NCT02797054|Primary|Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Follow-up||2 Months||||Percent of participants|||Number
2549257|NCT02857283|Secondary|Interleukin-6 (IL-6) Concentrations in Nasal Epithelial Lining Fluid (ELF): Change Immediately Post-Exposure From Baseline|"Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Nasal epithelial lining (ELF) will be collected from participants at a baseline visit within two weeks prior to each exposure, and at the following time points for each exposure: immediately after exiting the exposure chamber, and at 24 hours after the exposure.~The IL-6 concentration will be determined in each ELF sample by immunoassay. The change in IL-6 concentrations from baseline to immediately Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3 to determine the effect of ozone on the production of nasal IL-6."|Baseline, immediately post-exposure|All participants that completed the study|||pg/mL||Standard Error|Mean
2549258|NCT02857283|Primary|% Polymorphonuclear Leukocytes (PMN) in Nasal Lavage Fluid: Change 24 Hours Post-Exposure From Baseline|"Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Nasal lavage fluid (NLF) will be collected from participants at a baseline visit within two weeks prior to each exposure, and at the following time points for each exposure: immediately after exiting the exposure chamber, and at 24 hours after the exposure.~The % PMN as a percentage of total inflammatory cells (total of monocytes and macrophages, PMN, eosinophils, basophils, lymphocytes, and bronchial epithelial cells) will be determined in each NLF collection by differential counts of cells on cytospin slides. The change in the values from baseline to 24 hours Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3."|Baseline, 24 hours post-exposure|Subjects who produced NLF containing at least 60000 inflammatory cells at both baseline and at least one treatment|||percent PMN||Standard Error|Mean
2549259|NCT02857283|Primary|% Polymorphonuclear Leukocytes (PMN) in Nasal Lavage Fluid: Change Immediately Post Exposure From Baseline|"Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Nasal lavage fluid (NLF) will be collected from participants at a baseline visit within two weeks prior to each exposure, and at the following time points for each exposure: immediately after exiting the exposure chamber, and at 24 hours after the exposure.~The % PMN as a percentage of total inflammatory cells (total of monocytes and macrophages, PMN, eosinophils, basophils, lymphocytes, and bronchial epithelial cells) will be determined in each NLF collection by differential counts of cells on cytospin slides. The change in the values from baseline to immediately Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3."|Baseline, immediately post-exposure|Subjects who produced NLF containing at least 60000 inflammatory cells at both baseline and at least one treatment|||percent PMN||Standard Error|Mean
2549260|NCT02856880|Secondary|AUClive:Dead(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control|AUClive:dead(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method.|Baseline up to 90 min|PP population defined as those participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violation.|||live:dead stain ratio*min||Standard Error|Least Squares Mean
2549261|NCT02856880|Secondary|AUCregrowth(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control|AUCregrowth(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method.|Baseline up to 90 min|PP population defined as those participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violation.|||regrowth ratio*min||Standard Error|Least Squares Mean
2549262|NCT02856880|Secondary|AUCgly(0-90) for Test Zinc-IPMP, Test Zinc Non-IPMP, Positive Control, Non-SLS Negative Control and SLS Negative Control|AUCgly(0-90) for test zinc-IPMP, test zinc non-IPMP, positive control, non-SLS negative control and SLS negative control was calculated using trapezoidal method.|Baseline up to 90 min|PP population defined as those participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violation.|||plaque incubation pH*min||Standard Error|Least Squares Mean
2549263|NCT02856880|Primary|Area Under the Curve for Glycolysis (AUCgly(0-90)) of Test Zinc-IPMP and Non-SLS Negative Control|AUCgly(0-90) of Test zinc-IPMP and non-SLS negative control was calculated using trapezoidal method.|Baseline up to 90 minutes (min)|The Per Protocol (PP) population defined as those participants in the intent to treat (ITT) population who had at least one assessment of efficacy considered unaffected by protocol violation.|||plaque incubation pH*min||Standard Error|Least Squares Mean
2549264|NCT02856828|Secondary|Operative Time||intraoperatively||||minutes|||Number
2549265|NCT02856828|Secondary|Image Quality and Reproducibility of Desired Images|Measured by questionnaire related to image quality. Quality scale of 1-10, 1 being poor image quality and 10 being excellent image quality.|intraoperatively||||Quality Scale of 1-10, 10 being the best|||Number
2549266|NCT02856828|Primary|Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge||intraoperatively||||mrem|||Number
2549267|NCT02856828|Primary|Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge||intraoperatively||||mrem|||Number
2549268|NCT02856828|Primary|Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge||intraoperatively||||mGy|||Number
2549269|NCT02856282|Secondary|Number of Participants Who Consulted Physician When Test Product Was Used for 1 Month or More Continuously|Participants who answered the question, 'Did you consult with a doctor about continuing to use Pirinase Hayfever Relief for Adults 0.05% Nasal Spray product (if consumer answered no to symptoms improving)?', were evaluated to provide the data for this outcome measure.|2 allergy seasons (up to a maximum of 2 years)|Analysis population included all participants (N=39) who used the test product for atleast 1 month. Here, number of participants analyzed indicates, participants who answered the question for this outcome measure.|||Participants|||Count of Participants
2549270|NCT02856282|Secondary|Number of Participants Who Used the Test Product and Were Not Taking a Medication for Human Immunodeficiency Virus (HIV)|Participants who answered the question, 'Do you take medicine for HIV?', were evaluated to provide the data for this outcome measure.|2 allergy seasons (up to a maximum of 2 years)|Analysis population included all participants who completed the online survey.|||Participants|||Count of Participants
2549271|NCT02856282|Primary|Number of Participants Who Consulted Physician if Symptoms Were Not Improved After Using Test Product for 7 Days|Participants who answered the question, 'Did you consult a doctor about your symptoms not improving after using Pirinase Hayfever Relief for Adults 0.05% Nasal Spray product for 7 days? ', were evaluated to provide the data for this outcome measure.|2 allergy seasons (up to a maximum of 2 years)|Analysis population included all participants who completed the online survey. Here, number of participants analyzed indicates, participants who answered the question for this outcome measure.|||Participants|||Count of Participants
2549272|NCT02856282|Primary|Number of Pregnant/ Breastfeeding Participants Who Consulted Physician Before Product Use|Participants who answered the question, 'Did you talk to your doctor before using Pirinase Hayfever Relief for Adults 0.05% Nasal Spray product (if consumer said yes to pregnant or breastfeeding)? ', were evaluated to provide the data for this outcome measure.|2 allergy seasons (up to a maximum of 2 years)|Analysis population included all participants who completed the online survey. Here, number of participants analyzed indicates, participants who answered the question for this outcome measure.|||Participants|||Count of Participants
2549273|NCT02856282|Primary|Number of Participants With Improved Symptoms Who Reduced the Doses to 1 Spray Per Nostril Per Day|Participants who answered the question, 'Did you reduce the dose to 1 dose per nostril after your symptoms improved?', were evaluated to provide the data for this outcome measure.|2 allergy seasons (up to a maximum of 2 years)|Analysis population included all participants who completed the online survey. Here, number of participants analyzed indicates, participants who answered the question for this outcome measure.|||Participants|||Count of Participants
2549274|NCT02856282|Primary|Number of Participants Who Did Not Exceed the Correct Frequency of Use (2 Sprays Per Nostril Per Day)|Participants who answered the question, 'When using Pirinase Hayfever Relief for Adults 0.05% Nasal Spray product, did you use more than 2 sprays in each nostril per day?,' were evaluated to provide the data for this outcome measure.|2 allergy seasons (up to a maximum of 2 years)|Analysis population included all participants who completed the online survey.|||Participants|||Count of Participants
2549275|NCT02856282|Primary|Number of Participants Who Used the Test Product at Correct Age (18 Years or Older)|Participants who answered the question, 'What is your age?', were evaluated to provide the data for this outcome measure.|2 allergy seasons (up to a maximum of 2 years)|Analysis population included all participants who completed the online survey.|||Participants|||Count of Participants
2549276|NCT02855567|Secondary|Pain Score at Home Post-Operatively|Pain Score from 0-10 with higher score indicating more pain|up to 7 days post operatively||||score on a scale||95% Confidence Interval|Mean
2549277|NCT02855567|Secondary|Pain Score|Pain Score. Patients asked to rate pain score total from 0-10 with higher score indicating more pain|up to 4 hours post operatively||||score on a scale||95% Confidence Interval|Mean
2549278|NCT02855567|Secondary|Number of Patients Readmitted to the Hospital|Effectiveness of intra-operative acupuncture in post-operative pain control as measured by re-admission to the hospital for pain management.|2 weeks post-operatively||||Participants|||Count of Participants
2549279|NCT02855567|Secondary|Number of Pain Medication Tablets Used at Home Post-Operatively|Patients kept a log of pain medication use once they were discharged from the hospital for first 7 days post operatively.|7 days post-operatively||||tablets||Inter-Quartile Range|Median
2549280|NCT02855567|Primary|Morphine Equivalent Usage While in the Hospital|Effectiveness of intra-operative acupuncture in post-operative pain control as measured by narcotic use in the 24 hours post-operatively. Narcotic use monitored either through hospital records if patient is still admitted to the hospital or over the phone if the patient is discharged home prior to 24 hours post-operative.|Intra-operative and 24 hours post-operatively||||mg||Standard Deviation|Mean
2549281|NCT02855541|Secondary|Fat Mass||Measured after 4 weeks||||kg||Standard Deviation|Mean
2549282|NCT02855541|Secondary|Lean Mass||Measured after 4 weeks||||kg||Standard Deviation|Mean
2549283|NCT02855541|Secondary|Triglycerides||Measured after 4 weeks||||mmol/L||Standard Deviation|Mean
2549284|NCT02855541|Secondary|LDL Cholesterol||Measured after 4 weeks||||mmol/L||Standard Deviation|Mean
2549285|NCT02855541|Secondary|HDL Cholesterol||Measured after 4 weeks||||mmol/L||Standard Deviation|Mean
2549286|NCT02855541|Secondary|Systolic Blood Pressure||Measured after 4 weeks||||mmHg||Standard Deviation|Mean
2549287|NCT02855541|Primary|Maximum Oxygen Consumption|Maximum oxygen consumption (VO2max) will be used to determine physical fitness|Measured after 4 weeks||||L/min||Standard Deviation|Mean
2549288|NCT02855541|Primary|Blood Glucose|2-h Post Oral Glucose Tolerance Test Blood Glucose|Measured after 4 weeks||||mmol/L||Standard Deviation|Mean
2549289|NCT02855437|Primary|Feasibility of Using IVR vs. RheumPRO to Report Gout Flares|Feasibility ----Assessed by the percentage of participants completing answer IRV/RheumPRO queries.|6 months||||percentage of weekly response||Standard Deviation|Mean
2549290|NCT02855437|Primary|Preference IVR vs RheumPRO|Percentage of total study population preferring IVR vs. RheumPRO|6 months|Preference of IVR and StudyBuddy for reporting gout flares as reported by participants|||Participants|||Count of Participants
2549291|NCT02855411|Secondary|Number of Participants With Abnormalities in Physical Examination|A full physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination is focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Screening up to Week 12 or early termination|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
2549302|NCT02855411|Secondary|Change From Baseline in MCCB Overall Composite (Including All 7 Domains) to Week 12|The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers' recommended scoring algorithms.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
2549292|NCT02855411|Secondary|Number of Participants With Abnormalities in Neurological Examination|The extended neurological examination includes observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger nose, heel shin, Romberg, tandem walking, positional and gaze-evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination includes an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function is complemented by the Scale for the Assessment and Rating of Ataxia (SARA), a clinical scale based on a semi-quantitative assessment of cerebellar ataxia on an impairment level.|Screening up to Week 12 or early termination|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
2549293|NCT02855411|Secondary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs criteria of potential clinical concern: 1) systolic blood pressure <90 millimeters of mercury (mm Hg); 2) change from baseline of systolic blood pressure >=30 mm Hg; 3) diastolic blood pressure <50 mm Hg; 4) change from baseline of diastolic blood pressure >=20 mm Hg; 5) supine pulse rate <40 or >120 beats per minute (bpm); 6) standing pulse rate <40 or >140 bpm.|Screening up to Week 12 or early termination|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
2549294|NCT02855411|Secondary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG criteria of potential clinical concern: 1) QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): greater than or equal to (>=) 140 milliseconds (msec), >=50% increase from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% increase when baseline is greater than (>) 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec; 3) QTcF interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected using Fridericia's formula): absolute value of 450 to less than (<) 480 msec, 480 to <500 msec, >=500 msec; an increase from baseline of 30 to <60 msec or >=60 msec.|Screening up to Week 12 or early termination|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
2549295|NCT02855411|Secondary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality is assessed. Laboratory test parameters include hematology, clinical chemistry, urinalysis, follicle stimulating hormone, urine drug screen, and pregnancy test.|Screening up to Week 12 or early termination|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
2549296|NCT02855411|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All AEs (serious and non-serious) occurring following start of treatment or increasing in severity in any period were to be considered as a treatment emergent AE.|For AEs, the time frame was from taking first dose through and including last visit (28 days after the last dose), up to 113 days. For SAEs, the time frame was from the time that the participant provided informed consent to last visit, up to 143 days.|Study was terminated before participants were treated. No AE data was collected and there were no SAEs reported during the screening phase.||||||
2549297|NCT02855411|Secondary|CGI-I (Clinical Global Impression-Improvement) at Week 12|"The CGI-I consists of a single 7 point rating score total improvement, regardless of whether or not the change is due entirely to drug treatment. Raters select 1 response based on the following question, Compared to your patient's condition at the beginning of treatment, how much has your patient changed? Scores are: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; or 7=Very much worse. For the CGI-I, the participant's condition at the Day 1 (baseline) visit is the criterion for judging improvement at subsequent visits."|Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
2549298|NCT02855411|Secondary|Change From Baseline in the CGI‑S (Clinical Global Impression-Severity) to Week 12|"The CGI--S consists of a single 7 point rating score of illness severity. Raters select 1 response based on the following question, Considering your total clinical experience with this particular population, how mentally ill is your patient at this time? Scores are: 1=Normal, not ill at all; 2=Borderline mentally ill; 3=Mildly ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; or 7=Among the most severely ill participants."|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
2549299|NCT02855411|Secondary|Change From Baseline in the SCI‑PANSS Positive, Negative and General Psychopathology Subscales to Week 12|The SCI--PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale; 7 items that make up the Negative Scale; and 16 items that make up the General Psychopathology Scale. The Subscale scores are the sum of corresponding individual items.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
2549300|NCT02855411|Secondary|Change From Baseline in the SCI‑PANSS (Structured Clinical Interview Positive and Negative Symptoms Scale) Total to Week 12|The SCI-PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale; 7 items that make up the Negative Scale; and 16 items that make up the General Psychopathology Scale. The sum of the 30 items is defined as the total score.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
2549301|NCT02855411|Secondary|Change From Baseline in Each of the 6 Individual MCCB Domain Scores (Excluding MCCB Working Memory) to Week 12|The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers' recommended scoring algorithms.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
2549303|NCT02855411|Secondary|Change From Baseline in the MCCB Neurocognitive Composite (Excluding Social Cognition Domain) to Week 12|The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers' recommended scoring algorithms. The MCCB neurocognitive score contains all of the tests and domains of the MCCB composite score with the exception of social cognition.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
2549304|NCT02855411|Secondary|Number of Participants With Categorical Results on the Columbia-Suicide Severity Rating Scale (C-SSRS)|"C-SSRS responses are mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA). C-SSRS assesses whether participant experienced following: completed suicide (Category 1); suicide attempt (Category 2) (response of Yes on actual attempt); preparatory acts toward imminent suicidal behavior (Category 3) (Yes on aborted attempt, or interrupted attempt, or preparatory acts or behavior); suicidal ideation (Category 4) (Yes on wish to be dead, or non-specific active suicidal thoughts, or active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent); self-injurious behavior, no suicidal intent (Category 7) (Yes on has participant engaged in non-suicidal self-injurious behavior). Number of participants with Yes response for above mentioned categories was to be assessed."|Baseline, followed by weekly (Weeks 1 throughout 12), and 28 days after last dose|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
2549305|NCT02855411|Secondary|Scale for the Assessment and Rating of Ataxia (SARA)|SARA is a clinical scale that is based on a semi--quantitative assessment of cerebellar ataxia on an impairment level and complements the brief neurological examination. The SARA has 8 items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
2549306|NCT02855411|Primary|Change From Baseline in the UPSA‑VIM (University of California, San Diego [UCSD] Performance Based Skills Assessment - Validation of Intermediate Measures) to Week 12|The UPSA-VIM is a functional capacity measure of 5 general skills that were previously identified as essential to functioning in the community: general organization, finance, social/communications, transportation, and household chores. The UCSD Performance Based Skills Assessment involves role play tasks that are administered as simulations of events that the person might encounter in the community.|Baseline, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
2549307|NCT02855411|Primary|Change From Baseline in the MCCB (MATRICS Consensus Cognitive Battery) Working Memory Domain to Week 12|The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (ie, working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB yields scores for individual tests that assess specific cognitive domains as well as a composite score. Scores for the individual tests and the overall composite score for all tests are calculated according to the developers' recommended scoring algorithms.|Baseline, Week 2, Week 6, Week 12|Study was terminated before participants were treated and no data was collected for the endpoints.||||||
2549308|NCT02855359|Secondary|Duration of Objective Response and of Complete Response (CR) Between Study Arms in Part B|Study did not progress to Part B.|N/A - Endpoint not assessed|Endpoint not assessed; study did not progress to Part B.||||||
2549309|NCT02855359|Secondary|Objective Response Rate (ORR) at End Of Treatment (EOT) Between Study Arms in Part B|Study did not progress to Part B.|N/A - Endpoint not assessed|Endpoint not assessed; study did not progress to Part B.||||||
2549310|NCT02855359|Secondary|Overall Survival (OS) Between Study Arms in Part B|Study did not progress to Part B.|N/A - Endpoint not assessed|Endpoint not assessed; study did not progress to Part B.||||||
2549311|NCT02855359|Secondary|Progression-free Survival (PFS) Between Study Arms in Part B|Study did not progress to Part B.|N/A - Endpoint not assessed|Endpoint not assessed; study did not progress to Part B.||||||
2549312|NCT02855359|Secondary|Event-free Survival (EFS) Between Study Arms in Part B|Study did not progress to Part B|N/A - Endpoint not assessed|Endpoint not assessed; study did not progress to Part B.||||||
2549313|NCT02855359|Primary|Part A and Part B Outcome Measure: Incidence of Laboratory Abnormalities|Part A data reported; study did not progress to Part B. Laboratory abnormalities Grade 1+ are reported.|Up to 183 days||||Participants|||Count of Participants
2549314|NCT02855359|Primary|Part A and Part B Outcome Measure: Incidence of Adverse Events|Part A data only; study did not progress to Part B.|54.7 weeks||||Participants|||Count of Participants
2549315|NCT02855359|Primary|Part B Outcome Measure: Complete Response Rate (CR)|Study did not progress to Part B.|N/A - Endpoint not assessed|Endpoint not assessed; study did not progress to Part B.||||||
2549316|NCT02855086|Secondary|Incidence of Adverse Events|The incidence of serious and non-serious adverse events is reported as the number of adverse events (Grade 2 or higher), as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Data are reported by number of events by treatment level.|Up to 30 days||||Adverse events|||Number
2549317|NCT02855086|Primary|Tumor to Background Ratio (TBR)|Tumor to background ratios (TBR) will be generated from still images by comparing the relative fluorescence of normal and tumor tissue. The average fluorescence will be compared to the average fluorescence of the surrounding tissue using the paired student's T test for each specimen.|1 day||||Fluorescence Tumor to background ratio||Full Range|Mean
2549318|NCT02854631|Secondary|Change From Baseline in Prognostic Index: Maddrey Discriminant Function (DF) Score|Baseline Maddrey DF score is a prognostic tool used to determine the next step of treatment based on the severity of AH. Maddrey DF score of < 32 indicates mild to moderate AH and a lower chance of death in the next few months. Maddrey DF score of ≥ 32 indicates severe AH and a higher chance of death in the next few months. The score has no bounds.|Baseline (Day 1) and up to 24 weeks|Participants in the Full Analysis Set with available baseline and any postbaseline data were analyzed.|||Units on a scale||Standard Deviation|Mean
2549319|NCT02854631|Secondary|Change From Baseline in Prognostic Index: Child-Pugh-Turcotte (CPT) Score|CPT scores are used to assess the severity of cirrhosis. Scores can range from 5 to 15, with higher scores indicating a greater severity of disease|Baseline (Day 1) and up to 24 weeks|Participants in the Full Analysis Set with available baseline and any postbaseline data were analyzed.|||Units on a scale||Standard Deviation|Mean
2549320|NCT02854631|Secondary|Change From Baseline in Prognostic Index: Model for End-Stage Liver Disease (MELD) Score|MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity. Change from Baseline was calculated as the value at endpoint minus the value at Baseline.|Baseline (Day 1) and up to 24 weeks|Participants in the Full Analysis Set with available baseline and any postbaseline data were analyzed.|||Units on a scale||Standard Deviation|Mean
2549321|NCT02854631|Secondary|Percentage of Participants With Estimated Mortality at Month 2 and Month 6: Combined Scoring Including Lille Score at Day 7 and Baseline Model for End-Stage Liver Disease (MELD) Score|The Lille score is a tool used to predict which participants with severe AH were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity. A scoring system combining the Lille score at Day 7 and the baseline MELD score was used to calculate the percentage of participants expected to die by Month 2 and by Month 6.|Baseline and Day 7 Time Points used to calculate Overall Mortality Risk at Months 2 and 6|Participants in the Full Analysis Set with available data were analyzed.|||Percentage of participants||Standard Deviation|Mean
2549322|NCT02854631|Secondary|Lille Score at Day 7 as a Continuous Variable|The Lille score is a tool used to predict which participants with severe AH were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). The Lille score was calculated using baseline factors: age, albumin, total bilirubin, serum creatinine, prothrombin time; and the change in total bilirubin between baseline (Day 1) and Day 7.|Day 7|Participants in the Full Analysis Set with available data were analyzed.|||Lille score||Standard Deviation|Mean
2549323|NCT02854631|Secondary|Percentage of Participants With a Lille Null Response (Score ≥ 0.56) at Day 7|The Lille score is a tool used to predict which participants with severe AH were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). The Lille score was calculated using baseline factors: age, albumin, total bilirubin, serum creatinine, prothrombin time; and the change in total bilirubin between baseline (Day 1) and Day 7. Lille null response was defined as having a Lille score ≥ 0.56.|Day 7|Full Analysis Set|||Percentage of participants|||Number
2549324|NCT02854631|Secondary|Percentage of Participants With Lille Response (Score < 0.45) at Day 7|The Lille score is a tool used to predict which participants with severe alcoholic hepatitis (AH) were not responding to corticosteroid therapy. It ranges between 0 and 1, with low scores (< 0.16) indicating complete response or positive response to steroids (continue therapy) and high scores (≥ 0.56) indicating no response or poor response to steroids (stop therapy). The Lille score was calculated using baseline factors: age, albumin, total bilirubin, serum creatinine, prothrombin time; and the change in total bilirubin between baseline (Day 1) and Day 7. Lille response was defined as having a Lille score < 0.45.|Day 7|Full Analysis Set|||Percentage of participants|||Number
2549325|NCT02854631|Secondary|Change From Baseline in Liver Biochemistry Tests: International Normalized Ratio (INR)|Change from Baseline was calculated as the value at endpoint minus the value at Baseline.|Baseline (Day 1) and up to 24 weeks|Participants in the Full Analysis Set with available baseline and any postbaseline data were analyzed.|||Ratio||Standard Deviation|Mean
2549326|NCT02854631|Secondary|Change From Baseline in Liver Biochemistry Tests: Albumin|Change from Baseline was calculated as the value at endpoint minus the value at Baseline.|Baseline (Day 1) and up to 24 weeks|Participants in the Full Analysis Set with available baseline and any postbaseline data were analyzed.|||g/dL||Standard Deviation|Mean
2549327|NCT02854631|Secondary|Change From Baseline in Liver Biochemistry Tests: Bilirubin|Change from Baseline was calculated as the value at endpoint minus the value at Baseline.|Baseline (Day 1) and up to 24 weeks|Participants in the Full Analysis Set with available baseline and any postbaseline data were analyzed.|||mg/dL||Standard Deviation|Mean
2549328|NCT02854631|Secondary|Change From Baseline in Liver Biochemistry Tests: Alkaline Phosphatase|Change from Baseline was calculated as the value at endpoint minus the value at Baseline.|Baseline (Day 1) and up to 24 weeks|Participants in the Full Analysis Set with available baseline and any postbaseline data were analyzed.|||U/L||Standard Deviation|Mean
2549329|NCT02854631|Secondary|Change From Baseline in Liver Biochemistry Tests: Gamma Glutamyl Transferase (GGT)|Change from Baseline was calculated as the value at endpoint minus the value at Baseline.|Baseline (Day 1) and up to 24 weeks|Participants in the Full Analysis Set with available baseline and any postbaseline data were analyzed.|||U/L||Standard Deviation|Mean
2549330|NCT02854631|Secondary|Change From Baseline in Liver Biochemistry Tests: Aspartate Aminotransferase (AST)|Change from Baseline was calculated as the value at endpoint minus the value at Baseline.|Baseline (Day 1) and up to 24 weeks|Participants in the Full Analysis Set with available baseline and any postbaseline data were analyzed.|||U/L||Standard Deviation|Mean
2549331|NCT02854631|Secondary|Change From Baseline in Liver Biochemistry Tests: Alanine Aminotransferase (ALT)|Change from Baseline was calculated as the value at endpoint minus the value at Baseline.|Baseline (Day 1) and up to 24 weeks|Participants in the Full Analysis Set with available baseline and any postbaseline data were analyzed.|||U/L||Standard Deviation|Mean
2549332|NCT02854631|Secondary|Length of Hospital Stay|Length of initial hospital stay from first dose date of study drug was calculated for participants who were released from initial hospitalization separately from those who died during their initial hospitalization.|Up to 24 weeks|Participants in the Full Analysis Set with available data were analyzed. Participants released from initial hospitalization and those who died during initial hospitalization were analyzed separately, so a total of 41 participants and 45 participants were analyzed for the Selonsertib + Prednisolone and Placebo + Prednisolone arms, respectively.|||Days||Standard Deviation|Mean
2549333|NCT02854631|Secondary|Percentage of Participants With Infection|The occurrence of bacterial, fungal, or viral infections was recorded. An infection was considered definite in participants with clinical evidence of infection and a positive culture from a normally sterile source (with the exception of spontaneous bacterial peritonitis).|Up to 24 weeks|Full Analysis Set|||Percentage of participants|||Number
2549334|NCT02854631|Secondary|Percentage of Participants With Hepatorenal Syndrome (HRS)|The occurrence of HRS was confirmed based on the following diagnostic criteria from the International Ascites Club (IAC): 1) Cirrhosis with ascites, 2) Diagnosis of acute kidney injury (AKI) according to the ICA-AKI criteria, 3) Absence of shock, 4) No current or recent treatment with nephrotoxic drugs, and 5) Absence of parenchymal renal disease as indicated by proteinuria >500 mg/day, microhematuria (> 50 red blood cells per high power field) and/or abnormal renal ultrasonography.|Up to 24 weeks|Full Analysis Set|||Percentage of participants|||Number
2549335|NCT02854631|Secondary|Percentage of Participants Who Received a Liver Transplant|The percentage of participants who received a liver transplant by week 24 was calculated.|Day 28, Week 8, Week 12, and Week 24|Participants in the Full Analysis Set with available data were analyzed.|||Percentage of participants|||Number
2549336|NCT02854631|Secondary|Percentage of Participants With Survival at Week 24 Using Kaplan-Meier|The percentage of participants with survival at Week 24 using Kaplan-Meier was calculated.|Week 24|Full Analysis Set|||Percentage of participants||95% Confidence Interval|Number
2549337|NCT02854631|Secondary|Percentage of Participants With Survival at Week 12 Using Kaplan-Meier|The percentage of participants with survival at Week 12 using Kaplan-Meier was calculated.|Week 12|Full Analysis Set|||Percentage of participants||95% Confidence Interval|Number
2549338|NCT02854631|Secondary|Percentage of Participants With Survival at Week 8 Using Kaplan-Meier|The percentage of participants with survival at Week 8 using Kaplan-Meier was calculated.|Week 8|Full Analysis Set|||Percentage of participants||95% Confidence Interval|Number
2549339|NCT02854631|Secondary|Percentage of Participants With Survival at Day 28 Using Kaplan-Meier|The percentage of participants with survival at Day 28 using Kaplan-Meier was calculated.|Day 28|Full Analysis Set|||Percentage of participants||95% Confidence Interval|Number
2549340|NCT02854631|Secondary|Percentage of Participants Who Died by Week 24|The percentage of participants who died by Week 24 was calculated.|Week 24|Participants in the Full Analysis Set with available data were analyzed.|||Percentage of participants|||Number
2549341|NCT02854631|Secondary|Percentage of Participants Who Died by Week 12|The percentage of participants who died by Week 12 was calculated.|Week 12|Participants in the Full Analysis Set with available data were analyzed.|||Percentage of participants|||Number
2549342|NCT02854631|Secondary|Percentage of Participants Who Died by Week 8|The percentage of participants who died by Week 8 was calculated.|Week 8|Participants in the Full Analysis Set with available data were analyzed.|||Percentage of participants|||Number
2549343|NCT02854631|Secondary|Percentage of Participants Who Died by Day 28|The percentage of participants who died by Day 28 was calculated.|Day 28|Participants in the Full Analysis Set (participants who took at least 1 dose of study drug, and had histologically-confirmed severe alcoholic hepatitis (AH)) with available data were analyzed.|||Percentage of participants|||Number
2549344|NCT02854631|Primary|Percentage of Participants With Treatment-Emergent (TE) Adverse Events (AE), Serious AEs (SAE), AEs Leading to Premature Study Drug Discontinuation, and Grade 3 or 4 Laboratory Abnormalities|An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.|Up to Day 28 plus 30 days|Safety Analysis Set included participants who were randomized and took at least 1 dose of study drug.|||Percentage of participants|||Number
2549345|NCT02854605|Primary|Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities|Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any post-baseline time point, up to and including the date of last dose of study drug plus 30 days for participants who permanently discontinued study.|Up to 24 weeks plus 30 days|Safety Analysis Set|||Percentage of participants|||Number
2549346|NCT02854605|Primary|Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)|TEAEs were defined as 1 or both of the following: 1) Any adverse events (AE) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug, 2) Any AEs leading to premature discontinuation of study drug.|Up to 24 weeks plus 30 days|Safety Analysis Set included all participants who took at least 1 dose of study drug.|||Percentage of participants|||Number
2549347|NCT02854540|Secondary|Modified Minor's Sweat Testing as a Quantitative Measure of Palmar Sweat Production|Modified Minor's starch iodine testing, done with iodine imprints on plain paper, performed in office and at home to quantitatively measure sweat production.|Baseline to week 2|No data were collected for this outcome measure.||||||
2549348|NCT02854540|Secondary|Patient Reported Pain (Visual Analogue Scale)|"Patient-reported pain on the treated hand using an 11-point visual analogue scale. Scale range: 0-10, with zero representing no pain, and 10 representing the worst pain imaginable.~Participants recorded pain scores in a daily diary, and the score reported here is the average of all scores reported over the 2-week treatment period."|Baseline to week 2|Two participants who were not able to tolerate the lower threshold dose were excluded from the analysis. This outcome was prespecified for the treated hand only.|||score on a scale||Standard Deviation|Mean
2549349|NCT02854540|Primary|Change From Baseline in Palmar Sweat Production|Quantification of sweat production measured quantitatively using gravimetry, reported as milligrams of sweat per minute.|Baseline to week 2|Two participants who were not able to tolerate the lower threshold dose were excluded from the analysis.|||mg/min|Hands|Standard Deviation|Mean
2550155|NCT02839876|Secondary|Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)|Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).|36 hours||||score on a scale||Inter-Quartile Range|Median
2549350|NCT02854527|Secondary|Area Under the Curve of Rosuvastatin From 0 Extrapolated to Infinity (AUC 0-∞)|Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration|PKS|||nmol·h/L||Standard Error|Geometric Mean
2549351|NCT02854527|Secondary|Area Under the Curve of Metformin From 0 Extrapolated to Infinity (AUC 0-∞)|Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00 and 48:00 after drug administration|PKS|||nmol·h/L||Standard Error|Geometric Mean
2549352|NCT02854527|Secondary|Area Under the Curve of Furosemide From 0 Extrapolated to Infinity (AUC 0-∞)|Area under the concentration-time curve of furosemide in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00 and 24:00 after drug administration|PKS|||nmol·h/L||Standard Error|Geometric Mean
2549353|NCT02854527|Secondary|Area Under the Curve of Digoxin From 0 Extrapolated to Infinity (AUC 0-∞)|Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration|PKS|||nmol·h/L||Standard Error|Geometric Mean
2549354|NCT02854527|Primary|Maximum Concentration of Rosuvastatin (Cmax)|This outcome measure presents the maximum measured concentration of rosuvastatin in plasma (Cmax). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration|PKS|||nmol/L||Standard Error|Geometric Mean
2549355|NCT02854527|Primary|Area Under the Curve of Rosuvastatin From 0 to Last Quantifiable Data Point (AUC 0-tz)|Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration|PKS|||nmol·h/L||Standard Error|Geometric Mean
2549356|NCT02854527|Primary|Maximum Concentration of Metformin (Cmax)|This outcome measure presents the maximum measured concentration of metformin in plasma (Cmax). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00 and 48:00 after drug administration|PKS|||nmol/L||Standard Error|Geometric Mean
2549357|NCT02854527|Primary|Area Under the Curve of Metformin From 0 to Last Quantifiable Data Point (AUC 0-tz)|Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00 and 48:00 after drug administration|PKS|||nmol·h/L||Standard Error|Geometric Mean
2549358|NCT02854527|Primary|Maximum Concentration of Furosemide (Cmax)|This outcome measure presents the maximum measured concentration of furosemide in plasma (Cmax). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00 and 24:00 after drug administration|PKS|||nmol/L||Standard Error|Geometric Mean
2549359|NCT02854527|Primary|Area Under the Curve of Furosemide From 0 to Last Quantifiable Data Point (AUC 0-tz)|Area under the concentration-time curve of furosemide in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00 and 24:00 after drug administration|PKS|||nmol·h/L||Standard Error|Geometric Mean
2549360|NCT02854527|Primary|Maximum Concentration of Digoxin (Cmax)|This outcome measure presents the maximum measured concentration of digoxin in plasma (Cmax). Standard error presented is actually geometric standard error.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration|PKS|||nanomole per liter (nmol/L)||Standard Error|Geometric Mean
2549361|NCT02854527|Primary|Area Under the Curve of Digoxin From 0 to Last Quantifiable Data Point (AUC 0-tz)|Area under the concentration-time curve of digoxin in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz). Standard error presented is actually geometric standard error. CI - confidence interval, gMean - geometric mean.|Blood sampling at 2:00 (hour: minute) before drug administration, 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00, 72:00 and 96:00 after drug administration|The Pharmacokinetic (PK) analysis set (PKS) included all randomized subjects who were documented to have taken at least 1 dose of study drug and who have provided at least 1 primary or secondary PK endpoint that was not excluded from analysis due to non-evaluability or protocol violation relevant for the evaluation of the pharmacokinetics.|||nanomole hour per liter (nmol·h/L)||Standard Error|Geometric Mean
2549362|NCT02854059|Secondary|Number of Patients With Change From Baseline in Pharmacodynamics as Measured by Level of F(ab')2 Fragments|The efficacy of IdeS can be measured as change from baseline in F(ab')2 fragments (i.e. the antigen binding fragment of IgG).|From day of dosing until end of follow up on day 64|The concentration of F(ab')2 fragments in the patients' serum samples was not analysed because of the premature termination of the study due to the non-favourable risk-benefit profile in the first 2 patients and since the sponsor will no longer pursue the indication.||||||
2552278|NCT02797054|Primary|Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Follow-up||2 Months||||Percent of participants|||Number
2549363|NCT02854059|Secondary|Time-point for Maximum Serum Concentration of IdeS|The concentration of IdeS in serum was measured to identify the pharmacokinetic parameter Tmax of IdeS in TTP patients. Tmax refers to the time-point when the serum concentration of IdeS reaches maximum.|From day of dosing until day 14|Because of the premature termination of the study due to the non-favourable risk-benefit profile in the first 2 patients and since the sponsor will no longer pursue the indication, the analyses as described in the protocol were not performed. Instead, data collected for the 2 enrolled subjects were listed and presented graphically.|||hours||Full Range|Mean
2549364|NCT02854059|Secondary|Maximum Serum Concentration (Cmax) of IdeS|The concentration of IdeS in serum was measured to identify the pharmacokinetic parameter Cmax of IdeS in TTP patients.|From day of dosing until day 14|Because of the premature termination of the study due to the non-favourable risk-benefit profile in the first 2 patients and since the sponsor will no longer pursue the indication, the analyses as described in the protocol were not performed. Instead, data collected for the 2 enrolled subjects were listed and presented graphically.|||µg/mL||Full Range|Mean
2549365|NCT02854059|Secondary|Number of Patients Showing IdeS Immunogenicity as Measured by Anti-drug Antibodies|Most humans have been infected with S. pyogenes which is the origin of IdeS. It was therefore expected that patients in this study might have antibodies against IdeS before being exposed to IdeS in the study. The concentration of ant-IdeS antibodies was measured before dosing and throughout the study.|From day of dosing until end of follow up on day 64|Because of the premature termination of the study due to the non-favourable risk-benefit profile in the first 2 patients and since the sponsor will no longer pursue the indication, the analyses as described in the protocol were not performed. Instead, data collected for the 2 enrolled subjects were listed and/or presented graphically.|||Participants|||Count of Participants
2549366|NCT02854059|Secondary|Number of Patients With Change From Baseline in Pharmacodynamics as Measured by Level of IgG|IdeS cleaves IgG molecules. The concentration of uncleaved IgG in the patient's serum was measured throughout the study to determine change from baseline following IdeS administration.|From day of dosing until end of follow up on day 64|Because of the premature termination of the study due to the non-favourable risk-benefit profile in the first 2 patients and since the sponsor will no longer pursue the indication, the analyses as described in the protocol were not performed. Instead, data collected for the 2 enrolled subjects were listed and/or presented graphically.|||Participants|||Count of Participants
2549367|NCT02854059|Secondary|Number of Patients for Whom a Decreased ADAMTS13 Activity Returned to Normal Levels at Different Time-points in the Study|The ADAMTS13 activity in TTP patients is decreased. The efficacy of IdeS on ADAMTS13 activity was assessed throughout the study to identify the time-point of return to normal levels.|From day of dosing until end of follow up on day 64|Because of the premature termination of the study due to the non-favourable risk-benefit profile in the first 2 patients and since the sponsor will no longer pursue the indication, the analyses as described in the protocol were not performed. Instead, data collected for the 2 enrolled subjects were listed and/or presented graphically.|||Participants|||Count of Participants
2549368|NCT02854059|Secondary|Number of Patients With Change From Baseline in ADAMTS13 Antibody Levels|The efficacy of IdeS on ADAMTS13 antibody cleaving was measured througout the study as change from baseline in ADAMTS13 antibody concentration.|From day of dosing until end of follow up on day 64|Because of the premature termination of the study due to the non-favourable risk-benefit profile in the first 2 patients and since the sponsor will no longer pursue the indication, the analyses as described in the protocol were not performed. Instead, data collected for the 2 enrolled subjects were listed and/or presented graphically.|||Participants|||Count of Participants
2549369|NCT02854059|Secondary|Number of Patients With Change From Baseline in ADAMTS13 Activity|ADAMTS13 is an enzyme which is inhibited in patients with TTP. The efficacy of IdeS on ADAMTS13 activity was measured througout the study as change from baseline.|From day of dosing until end of follow up on day 64|Because of the premature termination of the study due to the non-favourable risk-benefit profile in the first 2 patients and since the sponsor will no longer pursue the indication, the analyses as described in the protocol were not performed. Instead, data collected for the 2 enrolled subjects were listed and/or presented graphically.|||Participants|||Count of Participants
2549370|NCT02854059|Primary|Safety and Tolerability as Measured by Type, Frequency and Intensity of Adverse Events|"Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation.~A treatment emergent AE (TEAE) is defined as any AE occurring after administration of the IMP and within the time of the residual drug effect period (i.e. 30 days after IMP administration).~AEs reported in ClinicalTrials.gov include TEAEs and post-treatment AEs, i.e. all AEs occurring after administration of IdeS until end of study.~Please refer to Adverse Event section for details on reported AEs"|From dosing until end of follow up on day 64|Because of the premature termination of the study due to the non-favourable risk-benefit profile in the first 2 patients and since the sponsor will no longer pursue the indication, the analyses as described in the protocol were not performed. Instead, data collected for the 2 enrolled subjects were listed and/or presented graphically.|||Adverse Events|||Number
2549371|NCT02853929|Secondary|Estimated Proportion of Infants With at Least One of the Indicators of Neurodevelopmental Impairment Using BSID-III (Bayley Scale for Infant Development, Version III)|The estimated proportion (expressed in percentage) of infants with a BSID-III indicator of neurodevelopmental delay was based on ASQ-3 black zone indicator and subsequent BSID-III assessment using the following formula: 100 * (Number of subjects with ASQ-3 below cut off / Number of enrolled subjects with available results) * (Number of subjects with at least one indicator of neurodevelopmental delay using BSID III / Number of subjects referred for BSID III evaluation)|At 9 months of age, 18 months of age, and 9 or 18 months of age|The analysis was performed on Total enrolled cohort, which included enrolled subjects with available results.|||Percentage of Infants||95% Confidence Interval|Number
2549391|NCT02853435|Secondary|Change From Baseline in Vital Sign Parameter Heart Rate for Part 3|Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|Baseline and up to 14 days|Safety population|||beats/minute||Standard Deviation|Mean
2549372|NCT02853929|Secondary|Number of Subjects Referred for Formal Neurodevelopmental Evaluation Using BSID-III (Bayley Scale for Infant Development, Version III)|Any subject who scored below the cut-off i.e., a score more than 2 Standard Deviations (SDs) below the mean score for the U.S. reference group (i.e., black zone in the score chart) in any of the 5 domains of the ASQ-3 was referred to a developmental specialist for a formal neurodevelopmental assessment (using the Bayley Scale for Infant Development, Version III BSID-III)|At 9 months of age, 18 months of age, and 9 or 18 months of age|The analysis was performed on subjects from the Total enrolled cohort, who scored, below the defined cut-off in any of the 5 domains, when using the ASQ-3 score scale.|||Participants|||Count of Participants
2549373|NCT02853929|Secondary|Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone|Neurodevelopmental status was measured by ASQ-3 score scale [ASQ-3, 2016] in the black zone. The ASQ-3 included a series of questions designed to assess 5 areas of development (communication, gross motor, fine motor, problem solving, and personal-social). Any subject who scored below the cut-off i.e., a score more than 2 Standard Deviations (SDs) below the mean score for the U.S. reference group (i.e., black zone in the score chart) in any of the 5 domains of the ASQ-3 was to be referred to a developmental specialist for a formal neurodevelopmental assessment (using the Bayley Scale for Infant Development, Version III [BSID-III])|At 9 months of age, 18 months of age, and 9 or 18 months of age|The analysis was performed on Total enrolled cohort, which included enrolled subjects with available results.|||Participants|||Count of Participants
2549374|NCT02853929|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, resulting in disability/incapacity|From booster dose up to study end (approximately 6 or 7 months, per subject)|The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available|||Participants|||Count of Participants
2549375|NCT02853929|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 31-day (Day 0-Day 30) follow-up period after booster vaccination|The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available|||Participants|||Count of Participants
2549376|NCT02853929|Secondary|Number of Subjects With Solicited General Symptoms|"Assessed solicited general symptoms were Drowsiness, Fever, Irritability/Fussiness and Loss of appetite.~Fever was defined as temperature ≥37.5 degree Celsius (°C) /99.5 degree Fahrenheit (°F) for oral, axillary or tympanic route, or ≥38.0°C/100.4°F on rectal route."|During the 4-day (Day 0-Day 3) follow-up period after booster vaccination|The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and for those with booster vaccine administration documented.|||Participants|||Count of Participants
2549377|NCT02853929|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness, swelling. Any redness, swelling is defined as a symptom with a surface diameter greater than 0 millimeter|During the 4-day (Day 0-Day 3) follow-up period after booster vaccination of two vaccines (Infanrix hexa and Prevenar 13)|The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and for those with booster vaccine administration documented.|||Participants|||Count of Participants
2549378|NCT02853929|Secondary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.|"Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off.~Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti- FHA and 2.187 IU/mL for anti-PRN"|At one month after the booster dose (Day 30)|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, after vaccination.|||Participants|||Count of Participants
2549379|NCT02853929|Secondary|Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations|Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in µg/mL.|Before the booster dose (Day 0) and One month after the booster dose (Day 30)|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before and after vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2549380|NCT02853929|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in mIU/mL.|Before the booster dose (Day 0) and One month after the booster dose (Day 30)|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before and after vaccination.|||mIU/mL||95% Confidence Interval|Geometric Mean
2549381|NCT02853929|Secondary|Anti-poliovirus Type 1, 2, 3 Antibody Titres|Anti-Poliovirus type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMT).|Before the booster dose (Day 0) and One month after the booster dose (Day 30)|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before and after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2549382|NCT02853929|Secondary|Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations|Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in IU/mL.|Before the booster dose (Day 0) and One month after the booster dose (Day 30)|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before and after vaccination.|||IU/ml||95% Confidence Interval|Geometric Mean
2552279|NCT02797054|Primary|Percent of Participants Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Follow-up||2 Months||||percent of participants|||Number
2549383|NCT02853929|Secondary|Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F)|"Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off.~Assay cut-off's for anti-pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) are 0.080 µg/mL, 0.075 µg/mL, 0.061 µg/mL, 0.198 µg/mL, 0.111 µg/mL, 0.102 µg/mL, 0.063 µg/mL, 0.66 µg/mL, 0.160 µg/mL, 0.111 µg/mL, 0.199 µg/mL, 0.163 µg/mL, 0.073 µg/mL respectively."|Before the booster dose (Day 0)|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before vaccination.|||Participants|||Count of Participants
2549384|NCT02853929|Secondary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN|"Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off.~Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN"|Before the booster dose (Day 0)|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before vaccination.|||Participants|||Count of Participants
2549385|NCT02853929|Secondary|Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP.|"Seroprotected subjects were defined as subjects with antibody concentrations/titers above or equal (≥) the assay cut-offs that are accepted immunological correlates of protection.~0.1 IU/mL for anti-D and anti-T, 10 mIU/mL for anti-HB's, 8 ED50 for anti-polio virus (type 1,2,3) and 0.15 µg/mL for anti-PRP were considered as immunological correlates of protection."|Before the booster dose (Day 0)|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before vaccination.|||Participants|||Count of Participants
2549386|NCT02853929|Primary|Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN))|"Booster response to PT, FHA and PRN antigens was defined as:~for subjects with pre-vaccination antibody concentration below the assay cut-off, post-vaccination antibody concentration ≥ 4 times the assay cut-off,~for subjects with pre-vaccination antibody concentration between the assay cut-off and below 4 times the assay cut-off, post-vaccination antibody concentration ≥ 4 times the pre-vaccination antibody concentration, and~for subjects with pre-vaccination antibody concentration ≥ 4 times the assay cut-off, post-vaccination antibody concentration ≥ 2 times the pre-vaccination antibody concentration~Seronegative (S-) subjects are those who have antibody concentration less than (<) assay cut-off.~Seropositive (S+) subjects are those who have antibody concentration ≥ assay cut-off prior to vaccination.~Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti- FHA and 2.187 IU/mL for anti-PRN"|At one month after the booster dose (Day 30)|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, after vaccination.|||Participants|||Count of Participants
2549387|NCT02853929|Primary|Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP)|"Seroprotected subjects were defined as subjects with antibody concentrations/titres above or equal (≥) the assay cut-offs that are accepted immunological correlates of protection.~0.1 International units per milliliter (IU/ml) for anti-D and anti-T, 10 milli-International units per milliliter (mIU/mL) for anti-HB's, 8 Effective Dose 50 (ED50) for anti-polio virus (type 1,2,3) and 0.15 microgram/milliliter (µg/mL) for anti-PRP were considered as immunological correlates of protection."|At one month after the booster dose (Day 30)|Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, after vaccination|||Participants|||Count of Participants
2549388|NCT02853435|Secondary|Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 3|Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (5 to 7 days post last dose) in Part 3. Only categories with significant values have been presented.|Up to 14 days|Safety Population|||Participants|||Count of Participants
2549389|NCT02853435|Secondary|Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 3|A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 3. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|Baseline and up to 14 days|Safety Population|||milliseconds||Standard Deviation|Mean
2549390|NCT02853435|Secondary|Change From Baseline in ECG Parameter Heart Rate for Part 3|A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|Baseline and up to 14 days|Safety Population|||beats/minute||Standard Deviation|Mean
2549392|NCT02853435|Secondary|Change From Baseline in Vital Sign Parameters SBP and DBP for Part 3|Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|Baseline and up to 14 days|Safety population|||millimeters of mercury||Standard Deviation|Mean
2549393|NCT02853435|Secondary|Change From Baseline in Hematology Parameter Blood Hematocrit for Part 3|Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|Baseline and up to 14 days|Safety Population|||Percentage of red blood cells in blood||Standard Deviation|Mean
2549394|NCT02853435|Secondary|Change From Baseline in Hematology Parameter Blood Ery. for Part 3|Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|Baseline and up to 14 days|Safety Population|||10^12 cells/liter||Standard Deviation|Mean
2549395|NCT02853435|Secondary|Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 3|Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|Baseline and up to 14 days|Safety Population|||femtoliters||Standard Deviation|Mean
2549396|NCT02853435|Secondary|Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 3|Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|Baseline and up to 14 days|Safety Population|||picograms||Standard Deviation|Mean
2549397|NCT02853435|Secondary|Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 3|Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|Baseline and up to 14 days|Safety Population|||grams/liter||Standard Deviation|Mean
2549398|NCT02853435|Secondary|Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 3|Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|Baseline and up to 14 days|Safety Population|||10^9 cells/liter||Standard Deviation|Mean
2549399|NCT02853435|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin and Serum Creatinine for Part 3|Blood samples were collected for the assessment of chemistry parameters namely serum bilirubin and serum creatinine for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm|Baseline and up to 14 days|Safety Population|||micromoles/liter||Standard Deviation|Mean
2549400|NCT02853435|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 3|Blood samples were collected for the assessment of chemistry parameters namely serum albumin and serum protein for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|Baseline and up to 14 days|Safety Population|||grams/liter||Standard Deviation|Mean
2549401|NCT02853435|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 3|Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|Baseline and up to 14 days|Safety Population|||International units/liter||Standard Deviation|Mean
2549402|NCT02853435|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 3|Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 3. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles). Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|Baseline and up to 14 days|Safety Population|||millimoles/liter||Standard Deviation|Mean
2549403|NCT02853435|Secondary|Number of Participants With Non-serious AEs and SAEs for Part 3|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to 14 days|Safety Population|||Participants|||Count of Participants
2549404|NCT02853435|Secondary|Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 2|Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 4+ 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (5 to 7 days post last dose) in Part 2. Only categories with significant values have been presented.|Baseline and up to 11 days|Safety Population|||Participants|||Count of Participants
2549405|NCT02853435|Secondary|Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 2|A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 2. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.|Baseline and up to 11 days|Safety Population|||milliseconds||Standard Deviation|Mean
2549406|NCT02853435|Secondary|Change From Baseline in ECG Parameter Heart Rate for Part 2|A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.|Baseline and up to 11 days|Safety Population|||beats/minute||Standard Deviation|Mean
2549407|NCT02853435|Secondary|Change From Baseline in Vital Sign Parameter Heart Rate for Part 2|Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.|Baseline and up to 11 days|Safety population|||beats/minute||Standard Deviation|Mean
2549408|NCT02853435|Secondary|Change From Baseline in Vital Sign Parameters SBP and DBP for Part 2|Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.|Baseline and up to 11 days|Safety population|||millimeters of mercury||Standard Deviation|Mean
2549409|NCT02853435|Secondary|Change From Baseline in Hematology Parameter Blood Hematocrit for Part 2|Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.|Baseline and up to 11 days|Safety Population|||Percentage of red blood cells in blood||Standard Deviation|Mean
2549410|NCT02853435|Secondary|Change From Baseline in Hematology Parameter Blood Ery. for Part 2|Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.|Baseline and up to 11 days|Safety Population|||10^12 cells/liter||Standard Deviation|Mean
2549411|NCT02853435|Secondary|Change From Baseline in Hematology Parameter Blood Ery. MCV for Part 2|Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.|Baseline and up to 11 days|Safety Population|||femtoliters||Standard Deviation|Mean
2549412|NCT02853435|Secondary|Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 2|Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.|Baseline and up to 11 days|Safety Population|||picograms||Standard Deviation|Mean
2549413|NCT02853435|Secondary|Change From Baseline in Hematology Parameters Ery. MCHC and Blood Hemoglobin for Part 2|Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.|Baseline and up to 11 days|Safety Population|||grams/liter||Standard Deviation|Mean
2549414|NCT02853435|Secondary|Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 2|Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.|Baseline and up to 11 days|Safety Population|||10^9 cells/liter||Standard Deviation|Mean
2549415|NCT02853435|Secondary|Change From Baseline in Clinical Chemistry Parameter Serum Estradiol for Part 2|Blood samples were collected for the assessment of chemistry parameter namely serum estradiol for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the indicated time point were analyzed. NA indicates standard deviation was not calculated as a single participant was analyzed.|Baseline and up to 11 days|Safety Population|||picomoles/liter||Standard Deviation|Mean
2549416|NCT02853435|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 2|Blood samples were collected for the assessment of chemistry parameters namely serum bilirubin, serum creatinine and serum direct bilirubin for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.|Baseline and up to 11 days|Safety Population|||micromoles/liter||Standard Deviation|Mean
2549417|NCT02853435|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 2|Blood samples were collected for the assessment of chemistry parameters namely serum albumin and serum protein for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.|Baseline and up to 11 days|Safety Population|||grams/liter||Standard Deviation|Mean
2549418|NCT02853435|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK in Part 2|Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.|Baseline and up to 11 days|Safety Population|||International units/liter||Standard Deviation|Mean
2549419|NCT02853435|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen in Part 2|Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 2. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. NA indicates participants crossed-over as follow-up visit occurred after Period 2.|Baseline and up to 11 days|Safety Population|||millimoles/liter||Standard Deviation|Mean
2549420|NCT02853435|Secondary|Number of Participants With Non-serious AEs and SAEs for Part 2|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to 11 days|Safety Population|||Participants|||Count of Participants
2549421|NCT02853435|Secondary|Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1b|Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Up to 11 days|Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549422|NCT02853435|Secondary|Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, QTcB and QTcF for Part 1b|A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 1b. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Baseline and up to 11 days|Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549423|NCT02853435|Secondary|Change From Baseline in ECG Parameter Heart Rate for Part 1b|A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Baseline and up to 11 days|Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2552280|NCT02797054|Primary|Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Post-intervention||1 day||||Percent of participants|||Number
2549424|NCT02853435|Secondary|Change From Baseline in Vital Sign Parameter Heart Rate for Part 1b|Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Baseline and up to 11 days|Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549425|NCT02853435|Secondary|Change From Baseline in Vital Sign Parameters SBP and DBP for Part 1b|Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Baseline and up to 11 days|Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549426|NCT02853435|Secondary|Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1b|Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Baseline and up to 11 days|Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549427|NCT02853435|Secondary|Change From Baseline in Hematology Parameter Blood Ery. for Part 1b|Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Baseline and up to 11 days|Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549428|NCT02853435|Secondary|Change From Baseline in Hematology Parameter Blood Ery. MCV for Part 1b|Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Baseline and up to 11 days|Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549429|NCT02853435|Secondary|Change From Baseline in Hematology Parameter Blood Ery. MCH for Part 1b|Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Baseline and up to 11 days|Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549430|NCT02853435|Secondary|Change From Baseline in Hematology Parameters Blood Ery. MCHC and Blood Hemoglobin for Part 1b|Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Baseline and up to 11 days|Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549431|NCT02853435|Secondary|Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1b|Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Baseline and up to 11 days|Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549432|NCT02853435|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin in Part 1b|Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Baseline and up to 11 days|Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2552281|NCT02797054|Primary|Percent of Participants Who Agreed They Felt Clear About Which Risks and Benefits of the HPV Vaccine Mattered Most to Them at Post-intervention||1 day||||Percent of participants|||Number
2549433|NCT02853435|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1b|Blood samples were collected for the assessment of chemistry parameters namely serum albuim and serum protein for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Baseline and up to 11 days|Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549434|NCT02853435|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum ALT, Serum AP, Serum AST and Serum CK for Part 1b|Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Baseline and up to 11 days|Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549435|NCT02853435|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1b|Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 1b. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Baseline and up to 11 days|Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549436|NCT02853435|Secondary|Number of Participants With AEs and SAEs for Part 1b|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Up to 11 days|Safety Population. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549437|NCT02853435|Secondary|Number of Participants With Abnormal Values on Urinalysis by Dipstick Analysis Part 1a|Urinalysis parameters assessed were urine ketones, urine glucose, urine occult blood, urine pH, urine specific gravity and urine protein. In this dipstick test, the level of ketones, glucose, occult blood, pH, specific gravity and protein in urine samples was recorded as negative trace, 1+, 3+, 5+, 6+, 7+ and 8+ (the plus sign increases with a higher level of ketones, occult blood, pH or specific gravity in the urine: 1+=slightly positive, 3+ to 5+=positive, 6+ and above=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up-to follow-up (5 to 7 days post last dose) in Part 1a. Only categories with significant values have been presented.|Up to 14 days|Safety Population|||Participants|||Count of Participants
2549438|NCT02853435|Secondary|Change From Baseline in ECG Parameters PR Interval, QRS Duration, QT Interval, Corrected QT Interval Using Bazett's Formula (QTcB) and Corrected QT Interval Using Fridericia's Formula (QTcF) for Part 1a|A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that measured PR interval, QRS duration, QT interval, QTcB and QTcF for Part 1a. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 14 days|Safety Population|||milliseconds||Standard Deviation|Mean
2549439|NCT02853435|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate for Part 1a|A 12 lead ECG was measured in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 14 days|Safety Population|||beats per minute||Standard Deviation|Mean
2549440|NCT02853435|Secondary|Change From Baseline in Vital Sign Parameter Heart Rate for Part 1a|Single vital signs were measured in semi-supine position after 5 minutes rest and included heart rate. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 14 days|Safety population|||beats/minute||Standard Deviation|Mean
2549441|NCT02853435|Secondary|Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part 1a|Single vital signs were measured in semi-supine position after 5 minutes rest and included SBP, DBP. Baseline was defined as assessments performed on Day 1 (pre-dose). Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 14 days|Safety population|||millimeters of mercury||Standard Deviation|Mean
2549527|NCT02852434|Secondary|Anticipated Pain Measured by Visual Analogue Scale|Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.|Preoperative; 30 minutes prior to procedure|Participants who completed the protocol are included in the analysis.|||units on a scale||Standard Deviation|Mean
2549442|NCT02853435|Secondary|Change From Baseline in Hematology Parameter Blood Hematocrit for Part 1a|Blood samples were collected for the assessment of hematology parameter namely blood hematocrit for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 14 days|Safety Population|||Percentage of red blood cells in blood||Standard Deviation|Mean
2549443|NCT02853435|Secondary|Change From Baseline in Hematology Parameter Blood Ery. for Part 1a|Blood samples were collected for the assessment of hematology parameter namely blood Ery. for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 14 days|Safety Population|||10^12 cells/liter||Standard Deviation|Mean
2549444|NCT02853435|Secondary|Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Volume (MCV) for Part 1a|Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCV for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 14 days|Safety Population|||femtoliters||Standard Deviation|Mean
2549445|NCT02853435|Secondary|Change From Baseline in Hematology Parameter Blood Ery. Mean Corpuscular Hemoglobin (MCH) for Part 1a|Blood samples were collected for the assessment of hematology parameter namely blood Ery. MCH for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 14 days|Safety Population|||picograms||Standard Deviation|Mean
2549446|NCT02853435|Secondary|Change From Baseline in Hematology Parameters Blood Erythrocyte (Ery.) Mean Corpuscular Hemoglobin Concentration (MCHC) and Blood Hemoglobin for Part 1a|Blood samples were collected for the assessment of hematology parameters namely blood Ery. MCHC and blood hemoglobin for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 14 days|Safety Population|||grams/liter||Standard Deviation|Mean
2549447|NCT02853435|Secondary|Change From Baseline in Hematology Parameters Blood Basophils, Blood Eosinophils, Blood Leukocytes, Blood Lymphocytes, Blood Monocytes, Blood Neutrophils and Blood Platelets for Part 1a|Blood samples were collected for the assessment of hematology parameters namely blood basophils, blood eosinophils, blood leukocytes, blood lymphocytes, blood monocytes, blood neutrophils and blood platelets for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 14 days|Safety Population|||10^9 cells/liter||Standard Deviation|Mean
2549448|NCT02853435|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum Bilirubin, Serum Creatinine and Serum Direct Bilirubin for Part 1a|Blood samples were collected for the assessment of chemistry parameters namely serum bilirubin, serum creatinine and serum direct bilirubin Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 14 days|Safety Population|||micromoles/liter||Standard Deviation|Mean
2549449|NCT02853435|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum Albumin and Serum Protein for Part 1a|Blood samples were collected for the assessment of chemistry parameters namely serum albumin and serum protein for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 14 days|Safety Population|||grams/liter||Standard Deviation|Mean
2549450|NCT02853435|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum Alanine Aminotransferase (ALT), Serum Alkaline Phosphatase (AP), Serum Aspartate Aminotransferase (AST) and Serum Creatinine Kinase (CK) for Part 1a|Blood samples were collected for the assessment of chemistry parameters namely serum ALT, serum AP, serum AST and serum CK for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose-visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 14 days|Safety Population|||International units/liter||Standard Deviation|Mean
2549451|NCT02853435|Secondary|Change From Baseline in Clinical Chemistry Parameters Serum Glucose, Serum Calcium, Serum Carbon Dioxide, Serum Chloride, Serum Potassium, Serum Sodium and Serum Urea Nitrogen for Part 1a|Blood samples were collected for the assessment of chemistry parameters namely serum glucose, serum calcium, serum carbon dioxide, serum chloride, serum potassium, serum sodium and serum urea nitrogen for Part 1a. Baseline was defined as assessments performed on Day -1. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value. Only those participants with data available at the specified time were analyzed (represented by n=x in the category titles).|Baseline and up to 14 days|Safety Population|||millimoles/liter||Standard Deviation|Mean
2549452|NCT02853435|Secondary|Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) for Part 1a|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Participants with non-serious AEs and SAEs has been reported. Safety Population comprised of all participants who received at least 1 dose of study medication and had at least 1 post dose safety assessment.|Up to 14 days|Safety Population|||Participants|||Count of Participants
2549453|NCT02853435|Primary|CLr for Part 3|PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.|PK Parameter Population|||liters/hour||Geometric Coefficient of Variation|Geometric Mean
2549454|NCT02853435|Primary|fe% for Part 3|PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.|PK Parameter Population|||Percentage dose of drug excreted||Geometric Coefficient of Variation|Geometric Mean
2549455|NCT02853435|Primary|Urine AUC (0-48) for Part 3|PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.|PK Parameter Population|||micrograms*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2549456|NCT02853435|Primary|Urine AUC (0-24) for Part 3|PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.|PK Parameter Population|||micrograms*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2549457|NCT02853435|Primary|Urine AUC (0-12) for Part 3|PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.|PK Parameter Population|||micrograms*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2549458|NCT02853435|Primary|Urine Ae (t1-t2) for Part 3|PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Only those participants available at the specific time points were analyzed (represented by n = X in the category titles).|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.|PK Parameter Population|||milligrams||Geometric Coefficient of Variation|Geometric Mean
2549459|NCT02853435|Primary|Total Unchanged Drug (Ae Total) for Part 3|PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours|PK Parameter Population|||milligrams||Geometric Coefficient of Variation|Geometric Mean
2549460|NCT02853435|Primary|t1/2 of Plasma Gepotidacin for Part 3|Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population|||hours||Geometric Coefficient of Variation|Geometric Mean
2549461|NCT02853435|Primary|Tlag of Plasma Gepotidacin for Part 3|Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population|||hours||Full Range|Median
2549462|NCT02853435|Primary|Tmax of Plasma Gepotidacin for Part 3|Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population|||hours||Full Range|Median
2549463|NCT02853435|Primary|Cmax of Plasma Gepotidacin for Part 3|Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population|||nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2549464|NCT02853435|Primary|AUC (0-t) of Plasma Gepotidacin for Part 3|Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population|||hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2549465|NCT02853435|Primary|AUC (0-infinity) of Plasma Gepotidacin for Part 3|Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 3. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population|||hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2549466|NCT02853435|Primary|CLr for Part 2|PK urine samples were collected at pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.|PK Parameter Population|||liters/hour||Geometric Coefficient of Variation|Geometric Mean
2549467|NCT02853435|Primary|fe% for Part 2|PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.|PK Parameter Population|||Percentage dose of drug excreted||Geometric Coefficient of Variation|Geometric Mean
2549468|NCT02853435|Primary|AUC (0-48) for Part 2|PK urine samples were collected at pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.|PK Parameter Population|||micrograms*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2549469|NCT02853435|Primary|AUC (0-24) for Part 2|PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.|PK Parameter Population|||micrograms*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2549470|NCT02853435|Primary|AUC (0-12) for Part 2|PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.|PK Parameter Population|||micrograms*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2549471|NCT02853435|Primary|Ae (t1-t2) for Part 2|PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.|PK Parameter Population|||milligrams||Geometric Coefficient of Variation|Geometric Mean
2549472|NCT02853435|Primary|Total Unchanged Drug (Ae Total) for Part 2|PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.|PK Parameter Population|||milligrams||Geometric Coefficient of Variation|Geometric Mean
2549473|NCT02853435|Primary|t1/2 of Plasma Gepotidacin for Part 2|Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population|||hours||Geometric Coefficient of Variation|Geometric Mean
2549474|NCT02853435|Primary|Tmax of Plasma Gepotidacin for Part 2|Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population|||hours||Full Range|Median
2552282|NCT02797054|Primary|Percent of Participants Who Agreed They Knew Enough About the Risks and Benefits of the HPV Vaccine at Post-intervention||1 day||||Percent of participants|||Number
2549475|NCT02853435|Primary|Tlag of Plasma Gepotidacin for Part 2|Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population|||hours||Full Range|Median
2549476|NCT02853435|Primary|Cmax of Plasma Gepotidacin for Part 2|Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population|||nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2549477|NCT02853435|Primary|AUC (0-t) of Plasma Gepotidacin for Part 2|Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population|||hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2549478|NCT02853435|Primary|AUC (0-infinity) of Plasma Gepotidacin for Part 2|Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 2. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population|||hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2549479|NCT02853435|Primary|t1/2 of Plasma Gepotidacin for Part 1b|Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population. The relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549480|NCT02853435|Primary|Tlag of Plasma Gepotidacin for Part 1b|Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population. The relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549481|NCT02853435|Primary|Tmax of Plasma Gepotidacin for Part 1b|Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population. The relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549482|NCT02853435|Primary|Cmax of Plasma Gepotidacin for Part 1b|Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population. The relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549483|NCT02853435|Primary|AUC (0-t) of Plasma Gepotidacin for Part 1b|Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population. The relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549529|NCT02852265|Secondary|Post-study Method Plan (Measurement: Participant Interview)|Plan to continue the COC and/or implant after the study based on interview at last visit|6 months|women using or starting a COC and having an etonogestrel implant placed; 1 lost to follow-up in each group from enrollment (n=10 in both groups at enrollment)|||Participants|||Count of Participants
2549484|NCT02853435|Primary|AUC (0-infinity) of Plasma Gepotidacin for Part 1b|Blood samples for PK analysis of gepotidacin was planned to be collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1b. Since the relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population. The relative bio-availability of the RC tablet formulation under fasted and fed conditions had been previously evaluated in Study BTZ117349 (NCT02045849), Part 1b was not conducted.||||||
2549485|NCT02853435|Primary|Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 48 Hours (AUC [0-48]) After Dosing for Part 1a|PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Only those participants with data available at the indicated time point were analyzed.|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours|PK Parameter Population.|||micrograms*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2549486|NCT02853435|Primary|Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 24 Hours (AUC [0-24]) After Dosing for Part 1a|PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours|PK Parameter Population|||micrograms*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2549487|NCT02853435|Primary|Area Under the Urine Concentration-time Curve Over Time 0 (Pre-dose) to 12 Hours (AUC [0-12]) for Part 1a|PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours.|PK Parameter Population|||micrograms*hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2549488|NCT02853435|Primary|Amount of Drug Excreted in Urine in a Time Intervals for Pre-dose, 0 to 2 Hours, 2 to 4 Hours, 4 to 6 Hours, 6 to 8 Hours, 8 to 12 Hours, 12 to 24 Hours, 24 to 36 Hours, and 36 to 48 Hours (Ae [t1-t2]) for Part 1a|PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Only those participants available at the specific time points were analyzed (represented by n = X in the category titles).|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours|PK Parameter Population|||milligrams||Geometric Coefficient of Variation|Geometric Mean
2549489|NCT02853435|Primary|Renal Clearance of Drug in Urine (CLr) for Part 1a|PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours|PK Parameter Population|||liters/hour||Geometric Coefficient of Variation|Geometric Mean
2549490|NCT02853435|Primary|Percentage of the Given Dose of Drug Excreted in Urine (fe%) of Plasma Gepotidacin for Part 1a|PK urine samples were collected at 0 (pre-dose), 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours|PK Parameter Population|||Percentage dose of drug excreted||Geometric Coefficient of Variation|Geometric Mean
2549491|NCT02853435|Primary|Total Unchanged Drug (Total Amount of Drug Excreted in Urine [Ae Total]) for Part 1a|PK urine samples were collected at 0 (predose), 0 to 2, 2 ot 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, 36 to 48 hours. PK parameters were determined from the urine concentration- time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher|Pre-dose, 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12, 12 to 24, 24 to 36, and 36 to 48 hours|PK Parameter Population|||milligrams||Geometric Coefficient of Variation|Geometric Mean
2549492|NCT02853435|Primary|Terminal Phase Half-life (t1/2) of Plasma Gepotidacin for Part 1a|Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population|||hours||Geometric Coefficient of Variation|Geometric Mean
2549493|NCT02853435|Primary|Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) of Plasma Gepotidacin for Part 1a|Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population|||hours||Full Range|Median
2552283|NCT02797054|Primary|Percent of Participants - Who Agreed They Felt Sure About the Best Choice Regarding the HPV Vaccine at Post-intervention||1 day||||Percent of participants|||Number
2549494|NCT02853435|Primary|Time to First Occurrence of Cmax (Tmax) of Plasma Gepotidacin for Part 1a|Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population|||hours||Full Range|Median
2549495|NCT02853435|Primary|Maximum Observed Concentration (Cmax) Determined Directly From the Concentration Time Data of Plasma Gepotidacin for Part 1a|Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Statistics has been presented on geometric LS means.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population|||nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2549496|NCT02853435|Primary|Relative Bioavailability of Drug (Frel) of Plasma Gepotidacin for Part 1a|Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. NA indicates data was not available as this was the reference capsule the Frel of each tablet type was being compared to.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population|||Ratio of AUC (0-infinity)||Geometric Coefficient of Variation|Geometric Mean
2549497|NCT02853435|Primary|Area Under the Concentration-time Curve (AUC) From Time 0 (Pre-dose) to Time of the Last Quantifiable Concentration (AUC [0-t]) of Plasma Gepotidacin for Part 1a|Blood samples for PK analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 mL of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. Statistics has been presented on geometric LS means.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population|||hours*nanograms/milliliters||Geometric Coefficient of Variation|Geometric Mean
2549498|NCT02853435|Primary|Area Under the Concentration-time Curve From Time 0 (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of Plasma Gepotidacin for Part 1a|Blood samples for pharmacokinetic (PK) analysis of gepotidacin were collected at Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in Part 1a. For each sample, 3 milliliters (mL) of blood was drawn via an indwelling catheter and/or direct venipuncture into tubes containing ethylenediaminetetraacetate anticoagulant. PK parameters were determined from the plasma concentration-time data and were calculated by standard non-compartmental analysis according to current working practices and using Phoenix WinNonlin Version 6.2.1 or higher. The PK Parameter Population consisted of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. Statistics has been presented on geometric least square (LS) means.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours (Day 1), 24, 36 hours (Day 2) and 48 hours (Day 3) in each treatment period|PK Parameter Population|||hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2549499|NCT02853331|Post-Hoc|Least Squares (LS) Mean Change From Baseline to Week 30 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score|EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. The first 28 questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). The last 2 questions represented the participant's assessment of overall health and quality of life on a 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100; with a high score indicating improved health status. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. The LS Mean change from baseline to Week 30 is presented.|Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 30|All participants who received at least 1 dose of study medication and had non-missing questionnaire assessments at baseline and Week 30.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2549500|NCT02853331|Other Pre-specified|Mean Baseline EORTC Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Score|EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. The mean baseline EORTC QLQ-C30 score is presented.|Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days])|All participants with non-missing questionnaire assessments at baseline.|||Score on a scale||Standard Deviation|Mean
2553525|NCT02774798|Secondary|Closing Elastance|In cmH20/mm2 - the ability of the anal canal to close after a period of stretch|at specific time point of measurement up to 1 hour||||cmH20/mm2||Standard Deviation|Mean
2549501|NCT02853331|Secondary|Least Squares (LS) Mean Change From Baseline to Week 54 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score|EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status.|Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 54||2021-01-31|01/2021||||
2549502|NCT02853331|Secondary|Time to True Deterioration (TTD) of the Functional Assessment of Cancer Therapy Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) Score|TTD was defined as time (in months) from the first dose of study treatment to the date of deterioration of FKSI-DRS Score. The FKSI-DRS was a questionnaire that asked the participant to rate 9 kidney cancer-related symptoms: lack of energy, fatigue, weight loss, pain, bone pain, shortness of breath, cough, fever, or blood in the urine. Each item was scored on a 5-point scale (0=not at all to 4=very much). FKSI-DRS total score ranged from 0 (most severe symptoms) to 36 (no symptoms) with a higher score indicating a better outcome. Deterioration was defined as a 3-point decrease (i.e. lower score) in symptom score and the time to true deterioration was the time to first onset of 3 or more decreases from baseline with confirmation under right-censoring rule (the last observation). The time to true deterioration as measured in months is presented.|Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)|All randomized participants who received at least 1 dose of study medication and completed at least 1 questionnaire assessment.|||Months||95% Confidence Interval|Median
2549503|NCT02853331|Secondary|Overall Survival (OS) Rate at Month 24 in All Participants|The OS rate was determined for all participants at Month 24 and was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment.|Month 24||2021-01-31|01/2021||||
2549504|NCT02853331|Secondary|Overall Survival (OS) Rate at Month 18 in All Participants|The OS rate was determined for all participants at Month 18 and was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 18 is presented.|Month 18|The analysis population consisted of all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2549505|NCT02853331|Secondary|Overall Survival (OS) Rate at Month 12 in All Participants|The OS rate was determined for all participants at Month 12 and was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 12 is presented.|Month 12|The analysis population consisted of all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2549506|NCT02853331|Secondary|Progression Free Survival Rate (PFS Rate) at Month 24 in All Participants|The PFS rate was determined in all participants at Month 24. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The date of PD was approximated by the date of the first assessment at which PD was documented per RECIST 1.1 by Blinded Independent Central Review (BICR). Death was always considered as confirmed PD. Participants who did not experience PFS were censored at the last disease assessment.|Month 24||2021-01-31|01/2021||||
2549507|NCT02853331|Secondary|Progression Free Survival Rate (PFS Rate) at Month 18 in All Participants|The PFS rate was determined in all participants at Month 18. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The date of PD was approximated by the date of the first assessment at which PD was documented per RECIST 1.1 by Blinded Independent Central Review (BICR). Death was always considered as confirmed PD. Participants who did not experience PFS were censored at the last disease assessment. The PFS rate at Month 18 is presented.|Month 18|The analysis population consisted of all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2549508|NCT02853331|Secondary|Progression Free Survival Rate (PFS Rate) at Month 12 in All Participants|The PFS rate was determined in all participants at Month 12. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The date of PD was approximated by the date of the first assessment at which PD was documented per RECIST 1.1 by Blinded Independent Central Review (BICR). Death was always considered as confirmed PD. Participants who did not experience PFS were censored at the last disease assessment. The PFS rate at Month 12 is presented.|Month 12|The analysis population consisted of all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2549509|NCT02853331|Secondary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented.|Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)|The analysis population consisted of all participants who received ≥1 dose of study treatment.|||Participants|||Count of Participants
2549510|NCT02853331|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.|Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)|The analysis population consisted of all participants who received ≥1 dose of study treatment.|||Participants|||Count of Participants
2549511|NCT02853331|Secondary|Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review|DOR was defined as the time from first documented evidence of a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 until progressive disease (PD) or death due to any cause, whichever occurred first. PD was defined per RECIST 1.1 as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. The DOR for all participants who experienced a CR or PR is presented.|Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)|The analysis population consisted of all randomized participants who experienced a CR or PR.|||Months||Full Range|Median
2549512|NCT02853331|Secondary|Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review|DCR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions), Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), or Stable Disease (SD) per RECIST 1.1 for ≥6 months. The DCR was calculated using the Miettinen & Nurminen method stratified by International Metastatic Renal Cell Carcinoma (RCC) Database Consortium (IMDC) risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World). The percentage of participants who experienced a CR, PR, or SD is presented.|Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)|The analysis population consisted of all randomized participants who experienced a PR, CR or SD for ≥6 months.|||Percentage of participants||95% Confidence Interval|Number
2549513|NCT02853331|Secondary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review|ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The ORR was calculated using the Miettinen & Nurminen method stratified by International Metastatic Renal Cell Carcinoma (RCC) Database Consortium (IMDC) risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World). The percentage of participants who experienced a CR or PR is presented.|Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)|The analysis population consisted of all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2549514|NCT02853331|Primary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. The OS for participants is presented.|Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)|The analysis population consisted of all randomized participants.|||Months||95% Confidence Interval|Median
2549515|NCT02853331|Primary|Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review|PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The PFS for participants is presented.|Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)|The analysis population consisted of all randomized participants.|||Months||95% Confidence Interval|Median
2549516|NCT02853123|Secondary|Change From Baseline After 6 Weeks of Treatment for Chronic Respiratory Questionnaire - Self Administered Standardized (CRQ-SAS) Dyspnoea Domain Score|CRQ-SAS was questionnaire to assess patients' perception of COPD and measures the impact of COPD on their life. This version was derived from the original CRQ tool & therefore, is scored on 7-point Likert-type scale (1: maximum impairment to 7: no impairment) for each 4 domains covering: dyspnea, fatigue, emotional function & mastery. The CRQ-SAS refers to the CRQ-Self-administered standardized format & contains 20 questions. The first part of the questionnaire contains 5 standardized dyspnea questions and the patients must indicate how much shortness of breath they have experienced while performing each of these 5 activities. The scores for each question of each domain were added together and divided by the number of questions answered in each domain. The higher scores indicate better health-related quality of life in the respective domain. Measure type is actually Adjusted Mean Change from Baseline.|Baseline and week 6|FAS including participants with available data for change from baseline for CRQ-SAS questionnaire after 6 weeks of treatment.|||Unit on Scale||Standard Error|Least Squares Mean
2549528|NCT02852434|Primary|Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion|Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.|Intraoperative; Immediately (0-30 seconds) following cervical dilation|Participants who completed the protocol are included in the analysis.|||units on a scale||Standard Deviation|Mean
2549517|NCT02853123|Secondary|Change From Baseline After 6 Weeks of Treatment for Chronic Respiratory Questionnaire - Self Administered Individualized (CRQ-SAI) Dyspnoea Domain Score|CRQ-SAI refers to the CRQ-Self-administered individualized format as it contains a dyspnea domain that is individualized to each patient. This version was derived from the original CRQ tool & therefore, is scored on 7-point Likert-type scale (1: maximum impairment to 7: no impairment) for each 4 domains covering: dyspnea, fatigue, emotional function & mastery. Dyspnea items may be selected from list of 26 suggested items or written in by the patients. The patients are asked to select up to 5 activities associated with breathlessness that they perform frequently and are most important to them. The scores for each question of each domain were added together and divided by the number of questions answered in each domain. The higher scores indicate better health-related quality of life in the respective domain. Measure type is actually Adjusted Mean Change from Baseline.|Baseline and week 6|FAS including participants with available data for change from baseline for CRQ-SAI questionnaire after 6 weeks of treatment.|||Unit on Scale||Standard Error|Least Squares Mean
2549518|NCT02853123|Secondary|Change From Baseline After 6 Weeks of Treatment for Intensity of Breathlessness (MBS-S) at 1, 2 and 2.5 Minute (Min) During the 3 Min Constant Speed Shuttle Test|At 1, 2 and 2.5 min during exercise, patients were asked to estimate the intensity of breathing discomfort that they were experiencing by matching their subjective estimate to descriptive phrases that best described the intensity of each sensation using the Modified Borg Scale (MBS-S). At 3 min or end of exercise (if 3 min not achieved), patients were asked to estimate the intensity of breathing discomfort that they were experiencing by matching their subjective estimate to descriptive phrases that best described the intensity of each sensation using the Modified Borg Scale (MBS-S). The modified Borg scale is 10-point subjective scoring system, in which a patient rates effort of exertion while performing a particular activity. The scale is 0 to 10, the higher the score, the greater the perceived difficulty. Measure type is actually Adjusted Mean Change from Baseline.|Baseline and week 6|FAS including participants with available data for MBS-S after 6 weeks of treatment.|||Unit on Scale||Standard Error|Least Squares Mean
2549519|NCT02853123|Secondary|Change From Baseline After 6 Weeks of Treatment for 1 Hour Post-dose Forced Vital Capacity|Forced Vital Capacity (FVC) is a standard measurement for the assessment of lung function. The best of 3 efforts was defined as the highest FVC, each obtained on any of 3 manoeuvres meeting the American Thoracic Society (ATS) criteria (to a maximum of 5 attempts). Measure type is actually Adjusted Mean Change from Baseline.|Baseline and week 6|FAS including participants with available data for change from baseline for FVC after 6 weeks of treatment.|||Litre (L)||Standard Error|Least Squares Mean
2549520|NCT02853123|Secondary|Change From Baseline After 6 Weeks of Treatment for 1 Hour Post-dose Forced Expiratory Volume|Forced Expiratory Volume in 1st second (FEV1) is a standard measurement for the assessment of lung function. The best of 3 efforts was defined as the highest FEV1, each obtained on any of 3 manoeuvres meeting the American Thoracic Society (ATS) criteria (to a maximum of 5 attempts). Measure type is actually Adjusted Mean Change from Baseline.|Baseline and week 6|FAS including participants with available data for change from baseline for FEV1 after 6 weeks of treatment.|||Litre (L)||Standard Error|Least Squares Mean
2549521|NCT02853123|Secondary|Change From Baseline After 6 Weeks of Treatment for Inspiratory Capacity Measured at the End of Exercise|Inspiratory Capacity (IC) is a standard measurement for the assessment of lung function. IC measurements were performed at the end of the 3min Constant Speed Shuttle Test (CSST). Measure type is actually Adjusted Mean Change from Baseline.|Baseline and week 6|FAS including participants with available data for change from baseline for inspiratory capacity measured end of exercise after 6 weeks of treatment.|||Litre (L)||Standard Error|Least Squares Mean
2549522|NCT02853123|Secondary|Change From Baseline After 6 Weeks of Treatment for Inspiratory Capacity Measured Prior to Exercise|Inspiratory Capacity (IC) is a standard measurement for the assessment of lung function. IC measurements were performed prior to the 3min Constant Speed Shuttle Test (CSST) (at rest). Measure type is actually Adjusted Mean Change from Baseline.|Baseline and week 6|FAS including participants with available data for change from baseline for inspiratory capacity measured prior to exercise after 6 weeks of treatment.|||Litre (L)||Standard Error|Least Squares Mean
2549523|NCT02853123|Primary|Change From Baseline in Intensity of Breathlessness Measured Using the Modified Borg Scale at the End of the 3 Minute (Min) Constant Speed Shuttle Test After 6 Weeks of Treatment.|At 3 min or end of exercise (if 3 min not achieved), patients were asked to estimate the intensity of breathing discomfort that they were experiencing by matching their subjective estimate to descriptive phrases that best described the intensity of each sensation using the Modified Borg Scale (MBS-S). The modified Borg scale is 10-point subjective scoring system, in which a patient rates effort of exertion while performing a particular activity. The scale is 0 to 10, the higher the score, the greater the perceived difficulty. Measure type is actually Adjusted Mean Change from Baseline.|Baseline and week 6|Full analysis set (FAS): This patient set was nested within the treated set (TS) and included patients who had baseline measurement and at least one post-baseline measurement for the primary endpoint. FAS including participants with available data for change from baseline in intensity of breathlessness after 6 weeks of treatment.|||Unit on Scale||Standard Error|Least Squares Mean
2549524|NCT02852434|Secondary|Overall Pain Measured by Visual Analogue Scale|Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.|Postoperative; Assessed once 10 minutes after procedure|Participants who completed the protocol are included in the analysis|||units on a scale||Standard Deviation|Mean
2549525|NCT02852434|Secondary|Speculum Placement Measured by Visual Analogue Scale|Measured by visual analogue scale (VAS), 0-100; Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.|Intraoperative; Immediately following speculum placement|Participants who completed the protocol are included in the analysis|||units on a scale||Standard Deviation|Mean
2549526|NCT02852434|Secondary|Baseline Pain Measured by Visual Analogue Scale|Measured by visual analogue scale (VAS), 0-100, Pain was measured on a 100 mm VAS scale. Lower scores correspond to less pain, higher scores correspond to more pain.|Immediately prior to procedure|Participants who completed the protocol are included in the analysis|||units on a scale||Standard Deviation|Mean
2552284|NCT02796963|Secondary|Number of Men Reporting Received HIV Self-testing Kits in the Last 3 Months Post-intervention||From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
2549530|NCT02852265|Secondary|COC Continuation Rate (Measurement: Participant Interview)|Continuation rate of COC over 6 months of evaluation regardless on whether or not the implant was still present at 6 months|6 months|women using or starting a COC and having an etonogestrel implant placed; 1 lost to follow-up in each group from enrollment (n=10 in both groups at enrollment)|||Participants|||Count of Participants
2549531|NCT02852265|Secondary|Bleeding Patterns (Measurement: Diaries)|Bleeding patterns while using a COC concomitantly with ENG implant|6 months|women using or starting a COC and having an etonogestrel implant placed; 1 lost to follow-up in each group from enrollment (n=10 in both groups at enrollment)|||Participants|||Count of Participants
2549532|NCT02852265|Secondary|Patient Interest (Measurement: Ability to Enroll)|"Demonstrate that women desiring a COC are willing to use ENG implant concomitantly as a continuous back-up contraceptive"|6 months|women using or starting a COC and having an etonogestrel implant placed; 1 lost to follow-up in each group from enrollment (n=10 in both groups at enrollment)|||Participants|||Count of Participants
2549533|NCT02852265|Primary|Number of Participants Evaluating ENG as Tolerable: Tolerability (Measurement: Diaries and Questionnaire)|Evaluate the tolerability (side effects) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception|6 months|All enrolled subjects, new or worsening side effects after 6 months of use in women using both an implant and a COC|||participants|||Number
2549534|NCT02852265|Primary|Number of Participants Evaluating ENG as Acceptable: Acceptability (Measurement: Questionnaire)|Evaluate the acceptability (continuation of the implant throughout the study) of concomitant etonogestrel (ENG) implant use in women choosing a combined oral contraceptive (COC) for contraception|6 months|All women enrolled in study|||Participants|||Count of Participants
2549535|NCT02851823|Primary|Clinical Attachment Level Change for Deep Pockets (7 mm≤PD)|"Change in clinical attachment level for deep pockets (7 mm≤PD) between baseline and 1 month.~Change in clinical attachment level for deep pockets (7 mm≤PD) between baseline and 3 month."|Baseline, 1 and 3 months||||mm||Standard Deviation|Mean
2549536|NCT02851823|Primary|Clinical Attachment Level Change for Moderately Deep Pockets (4 mm≤PD≤6 mm)|Change in clinical attachment level for moderately deep pockets (4 mm≤PD≤6 mm) between baseline and 1 month Change in clinical attachment level for moderately deep pockets (4 mm≤PD≤6 mm) between baseline and 3 month|Baseline, 1 and 3 months||||mm||Standard Deviation|Mean
2549537|NCT02851108|Secondary|Gametocyte Density|measured microscopically at baseline and on day 1, 2, 3, 7, 14, and 28 of follow-up|28 days|||||||
2549538|NCT02851108|Secondary|Mothers/Caretakers Questionnaire on Acceptance|Acceptance of the different treatment regimens by mothers/caretakers|14 days|||||||
2549539|NCT02851108|Secondary|Adverse Events (AE)|Reports of observed or self-reported adverse event|28 days|||||||
2549540|NCT02851108|Secondary|Gametocyte Prevalence|measured microscopically at baseline and on day 1, 2, 3, 7, 14, and 28 of follow-up|28 days|||||||
2549541|NCT02851108|Primary|Change in Haemoglobin Compared to the Baseline|Haemoglobin concentrations will be measured in the field using a HemoCue® (HemoCue® AB, Angelholm, Sweden)|7 days||||g/dl||Standard Deviation|Mean
2549542|NCT02851069|Other Pre-specified|Number of Participants With Concomitant Medications|"This includes all participants that took at least 1 concomitant medication from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose.~Abbreviations: ACE= angiotensin-converting-enzyme; GERD=gastroesophageal reflux."|Day 0 to EoT, maximum 24 weeks|Safety Population: defined as all enrolled participants who received at least one dose of the ABBVIE REGIMEN|||participants|||Number
2549543|NCT02851069|Other Pre-specified|Number of Participants With Co-morbidities at Baseline (Day 0)|Co-morbidities/co-infections were defined as hepatitis C virus (HCV) co-infections (human immunodeficiency virus [HIV] or hepatitis B virus [HBV], tuberculosis, schistosomiasis), liver/chronic hepatitis C (CHC) related co-morbidities (liver transplantation, hepatocellular carcinoma, non-alcoholic steatosis, alcoholic liver disease, primary biliary cirrhosis, auto-immune hepatitis, Wilson disease, cryoglobulinemia, porphyria cutanea tarda, auto-immune skin disease), and other co-morbidities (chronic kidney disease, psychiatric disorders, diabetes mellitus, insulin resistance, metabolic syndrome, lipid disorder, cardiovascular disease, immunologically mediated disease, hyper-/hypothyroidism, hemophilia, Thalassemia, sickle cell anemia, V. Willebrand disease, psychoactive substance dependency, kidney transplant, or other).|Baseline (Day 0)|CP|||participants|||Number
2549544|NCT02851069|Other Pre-specified|EQ-5D-5L Questionnaire VAS: Change From Baseline to 24 Weeks Post EoT|The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.|24 weeks post EoT (up to 24 weeks)|CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points.|||units on a scale||Standard Deviation|Mean
2549545|NCT02851069|Other Pre-specified|EQ-5D-5L Questionnaire VAS: Change From Baseline to 12 Weeks Post EoT|The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.|12 weeks post EoT (up to 24 weeks)|CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points.|||units on a scale||Standard Deviation|Mean
2549546|NCT02851069|Other Pre-specified|EQ-5D-5L Questionnaire VAS: Change From Baseline to EoT|The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. Participants also rated their perception of their overall health on a separate VAS. The scale is numbered from 0 to 100. The higher the score, the better the quality of life.|End of Treatment (up to 24 weeks)|CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points.|||units on a scale||Standard Deviation|Mean
2549583|NCT02849990|Secondary|Number of Patients With Pathologic T3 Disease After 3 Months of Treatment.|The presence of T3 disease (e.g. extraprostatic tumor not invading adjacent structures) will be determine from the prostatectomy specimen after 3 months of treament.|At 3 months||||Participants|||Count of Participants
2553526|NCT02774798|Secondary|Closing Pressure|The pressure (cmH20) at whihc the anal canal just closes|at specific time point of measurement up to 1 hour||||cmH20||Standard Deviation|Mean
2549547|NCT02851069|Other Pre-specified|EQ-5D-5L Questionnaire Index Score: Change From Baseline to 24 Weeks Post EoT|The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health).|24 weeks post EoT (up to 24 weeks)|CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points.|||units on a scale||Standard Deviation|Mean
2549548|NCT02851069|Other Pre-specified|EQ-5D-5L Questionnaire Index Score: Change From Baseline to 12 Weeks Post EoT|The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a HSI. HSI ranges is anchored at 0 (dead) and 1 (full health).|12 weeks post EoT (up to 24 weeks)|CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points.|||units on a scale||Standard Deviation|Mean
2549549|NCT02851069|Other Pre-specified|EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire Index Score: Change From Baseline to EoT|The EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by participants. The 5 items in the questionnaire comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate VAS. The higher the score, the worse the quality of life. For the VAS, the higher the score, the better the quality of life. Participant responses to the EQ-5D-5L were used to generate a health status index (HSI). HSI ranges is anchored at 0 (dead) and 1 (full health).|EoT (up to 24 weeks)|CP participants contributing to summary statistics. Changes were only calculated for participants with non-missing assessments at both time points.|||units on a scale||Standard Deviation|Mean
2549550|NCT02851069|Secondary|Percentage of Participants With Sustained Virologic Response at 24 Weeks (SVR24) After EoT|SVR24 was defined as HCV RNA < 50 IU/mL 24 weeks after EoT. During the course of the study, standard of care was changing and it was no longer common practice to assess SVR24.|24 weeks after EoT (up to 24 weeks)|CP participants with an SVR24 assessment|||percentage of participants||95% Confidence Interval|Number
2549551|NCT02851069|Secondary|Percentage of Participants With Rapid Virologic Response at Week 4 (RVR4)|RVR4 was defined as HCV RNA < 50 IU/mL at Week 4.|Week 4|CP|||percentage of participants||95% Confidence Interval|Number
2549552|NCT02851069|Secondary|Percentage of Participants Meeting On-treatment Virologic Failure|On-treatment virologic failure was defined as breakthrough (at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA≥ 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value ≥50 IU/mL).|Up to EoT, maximum of 24 weeks|CP|||percentage of participants|||Number
2549553|NCT02851069|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.|Up to EoT, maximum of 24 weeks|CP|||percentage of participants||95% Confidence Interval|Number
2549554|NCT02851069|Secondary|Percentage of Participants With Relapse at EoT|Relapse was defined as confirmed HCV RNA <50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL post treatment in participants who completed treatment (actual duration of ABBVIE REGIMEN is not shortened more than 7 days) and had HCV RNA results available in the SVR12 window.|12 weeks (i.e. at least 70 days) after the last dose of study drug|CP of participants with EoT response whose last post-treatment HCV RNA test result did not show virologic response|||percentage of participants||95% Confidence Interval|Number
2549555|NCT02851069|Secondary|Percentage of Participants With Relapse|Relapse was defined as confirmed HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≥50 IU/mL post-treatment in participants who were treated.|12 weeks (i.e. at least 70 days) after the last dose of study drug|CP|||percentage of participants|||Number
2549556|NCT02851069|Secondary|Percentage of Participants Meeting Each and Any SVR12 Non-response Criteria|"For a participant to be include in this analysis, the participant needed to meet each and any of the following SVR12 non-response categories:~On-treatment virologic failure (breakthrough [defined as at least one documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥50 IU/mL]);~Relapse (defined as HCV RNA <50 IU/mL at actual EoT followed by HCV RNA ≥50 IU/mL post-treatment for participants who completed treatment [not more than 7 days shortened]);~Premature study drug discontinuation with no on-treatment virologic failure;~Missing SVR12 data and/or none of the above criteria (including participants with missing SVR12 data).~Abbreviations: EoT=end of treatment."|During treatment and 12 weeks (i.e. at least 70 days) after the last dose of study drug (up to 24 weeks)|CP|||percentage of participants|||Number
2549557|NCT02851069|Secondary|Number of Participants Meeting Premature Study Drug Discontinuation|Premature study drug discontinuation was defined as participants who prematurely discontinued study drug (ABBVIE REGIMEN or RBV) and who experienced no on-treatment virologic failure (defined as breakthrough [at least 1 documented HCV RNA ˂50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥50 IU/mL]).|Up to EoT, maximum of 24 weeks|CP|||participants|||Number
2549558|NCT02851069|Secondary|Percentage of Participants With Virologic Response at End of Treatment (EoT)|Virologic response is defined as HCV RNA level <50 IU/mL.|Up to EoT, maximum of 24 weeks|CP|||percentage of participants||95% Confidence Interval|Number
2549584|NCT02849990|Secondary|Number of Patients With no Nodal Metastases After 3 Months of Treatment.|The presence of tumor cells within surgically excised lymph nodes will be assessed after 3 months of treament.|At 3 months||||Participants|||Count of Participants
2549559|NCT02851069|Primary|Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks (SVR12) Post-treatment|SVR12 was defined as plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level ˂50 IU/mL 12 weeks after end of treatment (EoT) (defined as after last actual dose of the ABBVIE REGIMEN [paritaprevir/ritonavir - ombitasvir ± dasabuvir] or ribavirin [RBV]).|12 weeks (i.e. 70 to 126 days) after the last dose of study drug (up to 24 weeks)|Core Population (CP): defined as all participants of the target population (all participants in the safety population who met inclusion criteria) who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants||95% Confidence Interval|Number
2549560|NCT02850978|Secondary|Change of COPD Assessment Test (CAT) Score From Baseline to Week 12|The COPD Assessment Test™ (CAT) is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health). The CAT questionnaire has the advantage of a reduced number of items and could be used to assess the effects of inhaled therapies. The CAT score was the sum of the values corresponding to the answers to the eight questions.|Baseline and Week 12|Effectiveness set: The effectiveness set included all patients in the safety set except for those patients who had no any values of CAT, Forced Expiratory Volume in one second (FEV1) and Forced Vital Capacity (FVC) after Spiolto® Respimat® administration.|||Unit on a scale||Standard Deviation|Mean
2549561|NCT02850978|Primary|Percentage of Participants With Adverse Drug Reactions|"Percentage of participants with adverse drug reactions (ADR). An adverse drug reaction (ADR) is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Spiolto® Respimat® as Yes."|From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.|Safety set: This patient set includes all patients who were documented to have taken at least one dose of Spiolto® Respimat® excluding no visit after Spiolto® Respimat® administration.|||Percentage of participants (%)|||Number
2549562|NCT02850965|Secondary|The Percentage of Patients With Drug-related Adverse Events (AEs)|The secondary safety endpoint was defined as the percentage of patients with drug-related adverse events (AEs).|From first drug administration until 10 weeks after last drug administration, up to 34 weeks.|Safety Analysis Set (SAF): The SAF contained all patients who provided signed informed consent, who were randomized, and who received at least one dose of trial medication.|||Percentage of patients (%)|||Number
2549563|NCT02850965|Secondary|The Percentage of Patients Achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16|"The DLQI is a subject-administered, 10-question, that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has a 1-week recall period. Every item score ranges from 0 (not relevant/not at all) to 3 (very much). Question 7 is a yes/no question where yes is scored as 3.~The DLQI total score was calculated by summing the scores of each question resulting in a range of 0 to 30 where 0-1 = no effect on subject's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on the subject's life.~The higher the score, the more the quality of life is impaired. If the answer to 1 question in a domain was missing, that domain was treated as missing. If 2 or more questions were left unanswered (missing), DLQI total score was treated as missing. Percentage = least squares means per treatment groups back transformed using inverse logit function."|Week 16|FAS|||Percentage (%)|||Number
2549564|NCT02850965|Secondary|The Percentage of Patients With a Static Physician's Global Assessment (sPGA) ≤1 (Clear or Almost Clear) at Week 16|"The Static Physician's Global Assessment (sPGA) is a 5-point score ranging from 0 to 4, based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions.~The assessment was considered static, which referred to the patient's disease state at the time of the assessment, without comparison to any of the patient's previous disease states (dynamic), whether at Baseline or at a previous visit. A lower score indicated less body coverage, with 0 being clear, 1 being almost clear, and 4 being.~Percentage = least squares means per treatment groups back transformed using inverse logit function."|Week 16|FAS|||Percentage (%)|||Number
2549565|NCT02850965|Secondary|The Mean Percentage Improvement in PASI at Week 16|"The PASI tool provides numeric scoring for a patient's overall psoriasis disease state, ranging from 0 to 72. Head (h), trunk (t), upper extremities (u) and lower extremities (l) areas were assessed; correspond to 10, 30, 20, and 40% of the total body area, respectively. The signs of severity, erythema (E), induration (I) and desquamation (D) of lesions were assessed using a numeric scale of 0 to 4 where 0 was a complete lack of cutaneous involvement and 4 was the severest possible involvement. The area of psoriatic involvement of these areas (Ah, At, Au, and Al) was given a numerical value: 0 = no involvement, 1 =<10%, 2 =10 to <30%, 3 =30 to <50%, 4 =50 to <70%, 5 =70 to <90%, and 6 =90 to 100% involvement.~PASI = 0.1(Eh+Ih+Dh)Ah + 0.3(Et+It+Dt)At + 0.2(Eu+Iu+Du)Au + 0.4(El+Il+Dl)Al.~Results based on PASI mean percentage improvement from Baseline after 16 weeks of treatment = overall mean + treatment group + Baseline PASI + prior exposure to a biological agent + random error."|Week 16|FAS|||Percentage (%)||95% Confidence Interval|Least Squares Mean
2549566|NCT02850965|Secondary|The Percentage of Patients With a PASI 75 Response at Week 24|"The PASI tool provides numeric scoring for a patient's overall psoriasis disease state, ranging from 0 to 72. Head (h), trunk (t), upper extremities (u) and lower extremities (l) areas were assessed; correspond to 10, 30, 20, and 40% of the total body area, respectively. The signs of severity, erythema (E), induration (I) and desquamation (D) of lesions were assessed using a numeric scale of 0 to 4 where 0 was a complete lack of cutaneous involvement and 4 was the severest possible involvement. The area of psoriatic involvement of these areas (Ah, At, Au, and Al) was given a numerical value: 0 = no involvement, 1 = <10%, 2 = 10 to <30%, 3 = 30 to <50%, 4 = 50 to <70%, 5 = 70 to <90%, and 6 = 90 to 100% involvement.~PASI = 0.1(Eh+Ih+Dh)Ah + 0.3(Et+It+Dt)At + 0.2(Eu+Iu+Du)Au + 0.4(El+Il+Dl)Al.~Percentage = least squares means per treatment groups back transformed using inverse logit function."|Week 24|FAS|||Percentage (%)|||Number
2549585|NCT02849990|Secondary|Number of Patients With a Near Pathologic Complete Response After 3 Months of Treatment|The near pathologic complete response will be defined as =< 5 mm of residual tumor as assessed on prostatectomy specimens after 3 months of treatment.|At 3 months||||Participants|||Count of Participants
2549586|NCT02849990|Secondary|Overall Survival (OS)|Will be estimated using Kaplan-Meier methods and 95% CI will be estimated using Greenwood's formula.|At 2 years|||||||
2553527|NCT02774798|Secondary|Opening Elastance|in cmH20/mm2 - the resistance of the anal canal to stretch|at specific time point of measurement up to 1 hour||||cmH20/mm2||Standard Deviation|Mean
2549567|NCT02850965|Primary|The Percentage of Patients With at Least 75% Reduction in Psoriasis Area and Severity Index (PASI 75) Response at Week 16|"The PASI tool provides numeric scoring for a patient's overall psoriasis disease state, ranging from 0 to 72. Head (h), trunk (t), upper extremities (u) and lower extremities (l) areas were assessed; correspond to 10, 30, 20, and 40% of the total body area, respectively. The signs of severity, erythema (E), induration (I) and desquamation (D) of lesions were assessed using a numeric scale of 0 to 4 where 0 was a complete lack of cutaneous involvement and 4 was the severest possible involvement. The area of psoriatic involvement of these areas (Ah, At, Au, and Al) was given a numerical value: 0 = no involvement, 1 = <10%, 2 = 10 to <30%, 3 = 30 to <50%, 4 = 50 to <70%, 5 = 70 to <90%, and 6 = 90 to 100% involvement.~PASI = 0.1(Eh+Ih+Dh)Ah + 0.3(Et+It+Dt)At + 0.2(Eu+Iu+Du)Au + 0.4(El+Il+Dl)Al.~Percentage = least squares means per treatment groups back transformed using inverse logit function."|Week 16|Full Analysis Set (FAS): The FAS contained all randomized patients who received at least one dose of trial medication, and had all efficacy measures relevant for the PASI 75, measured at baseline and at least once post-baseline (prior to or on Week 16).|||Percentage (%)|||Number
2549568|NCT02850276|Secondary|Medical Outcomes Study Questionnaire|Medical Outcomes Study (MOS-HIV) quality of life questionnaire. It is a 35 item questionnaire covering 11 dimensions of health including physical functioning, role functioning, pain, social functioning, emotional well-being, energy/fatigue, cognitive functioning, general health, health distress, overall QOL, and health transition. The total scale ranges from 0-100 with a higher score representing better functioning and well-being.|Baseline and week 8||||score on a scale||Standard Deviation|Mean
2549569|NCT02850276|Secondary|The Composite Autonomic Symptom Score (COMPASS)|The gastrointestinal domain domain score of the COMPASS contains 12 items which reflect gastrointestinal symptoms of autonomic function. It is scored on a total scale of 0-28, with higher numbers reflecting worse symptoms.|Baseline and week 8||||score on a scale||Standard Deviation|Mean
2549570|NCT02850276|Secondary|Change in IL-6 Plasma Level|Change in IL-6 plasma level at week 8 as compared to baseline. Plasma interleukin-6 (IL-6), an important inflammatory mediator which predicts mortality in HIV as well as multiple medical co-morbidities, presumably via inflammatory mechanisms.|Baseline and week 8||||mean florescence intensity||Inter-Quartile Range|Median
2549571|NCT02850276|Secondary|Change in TNFα Level|TNFα is a pro-inflammatory cytokine which is induced by components of translocating bacteria. Change in TNFα level at week 8 compared to baseline|Baseline and week 8||||mean florescence intensity||Full Range|Median
2549572|NCT02850276|Secondary|Change in sCD14 Level|Change in sCD14 level at week 8 as compared to baseline. sCD14 is a marker of macrophage activation commonly used as an indirect measure of translocation|Baseline and week 8||||mean florescence intensity||Inter-Quartile Range|Median
2549573|NCT02850276|Secondary|Mean Percent Retention of Gastric Contents on Gastric Emptying Study|Percent retention of gastric contents on gastric emptying study. GI dysmotility calculated from gastric emptying scintigraphy - measurement of the percent retention of gastric contents at 4 hours.|Baseline and week 8||||percent retention of gastric contents||Inter-Quartile Range|Mean
2549574|NCT02850276|Primary|Number of Participants With Reduction in Small Intestinal Bacterial Overgrowth (SIBO)|"Number of participants with reduction in Small intestinal bacterial overgrowth (SIBO) assessed with breath testing after 8 weeks of treatment.~The hydrogen breath test for the detection of small intestinal bacterial overgrowth (SIBO), obtained by having participants exhale into a plastic bag. the hydrogen content of the samples is measured using a commercially available analyzer."|week 8||||Participants|||Count of Participants
2549575|NCT02850276|Primary|Change in Breath Test|Breath Test at week 8 as compared to baseline. Breath test results is the rise in the combined hydrogen and methane during the breath test.|baseline and week 8||||ppm||Inter-Quartile Range|Median
2549576|NCT02850159|Primary|Change of Freezing of Gait Questionnaire (FOG-Q)|Change of a self-assessment scale for evaluating participant freezing of gait (FOG) symptoms after non-invasive brain stimulation (NIBS) for 5 consecutive days ((freezing of gait questionnaire (FOG-Q) after NIBS) - (FOG-Q before NIBS) Minimum score: -5 Maximum score: 0 Lower values represent a better outcome.|Assessed at T0, pre-NIBS at day 1 and T1, immediately after NIBS at day 5||||score||Standard Deviation|Mean
2549577|NCT02850068|Other Pre-specified|Patient Complications (Number of Participants With Complications at Month 6)|The number and description of complications, adverse events, or poor outcomes that are secondary to the GAE procedure, which will be summarized using counts and simple statistics (number of participants with complications at month 6)|6 months||||Participants|||Count of Participants
2549578|NCT02850068|Secondary|Reduction in Medication (Percentage of Participants With a Reduction in Medication Therapy at Month 6)|Reduction in the number or strength of previously initiated OA medical therapy (e.g. NSAIDs) at 6 months follow-up, which will be summarized using counts and simple statistics (percentage of participants with a reduction in medication therapy at month 6 months).|6 months||||percentage of participants||95% Confidence Interval|Number
2549579|NCT02850068|Primary|Patient Pain (mm)|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain."|6 months||||mm||95% Confidence Interval|Mean
2549580|NCT02850068|Primary|Patient Function (Units on a Scale)|Western Ontario and McMaster University Osteoarthritis Index will be used to measure function. This is a score derived from a questionnaire in which the patient answers questions regarding rheumatic symptoms, stiffness, pain and how it affects the ability to function. Participants are asked to rate each question on a scale from 0 to 4 (0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely) for the level of difficulty to complete each task. The categories are then totaled for an overall score out of 96. Higher values indicate greater levels of pain, stiffness, and functional limitations.|6 months||||units on a scale||95% Confidence Interval|Mean
2549581|NCT02849990|Secondary|The Proportion of Men Who Receive Adjuvant Radiation Therapy|Patients that received radiation following prostatetomy|Up to 1 year post prostatectomy||||Participants|||Count of Participants
2549582|NCT02849990|Secondary|The Biochemical (i.e. Prostate-specific Antigen) Progression-free Survival (PFS) Estimate|Prostate-specific antigen progression (i.e. biochemical failure) will be defined per the American Urological Association guidelines (i.e. confirmed prostate-specific antigen post-radical prostatectomy >= 0.2 ng/mL). Will be estimated using Kaplan-Meier methods and 95% CI will be estimated using Greenwood's formula.|At 2 years|||||||
2549589|NCT02849990|Primary|Pathologic Complete Response Rate as Assessed From Prostatectomy Specimens Following Neoadjuvant Treatment|Pathologic complete response is defined as no evidence of cancer on fully submitted prostatectomy specimens using standard surgical pathology assessments (i.e. H&E assessment will be used for the purpose of defining pathologic complete response per protocol) at 3 months.|At 3 months||||Participants|||Count of Participants
2549590|NCT02849938|Secondary|Parent Survey|Overall satisfaction with device, comfort with Device, satisfaction with clinician interactions and development of plans of care; Questions asked using 4 point Likert scale (4 = Very Satisfied , 1=Very Dissatisfied). Higher score more satisfaction|3 months|Control group participants did not answer questions regarding the tele health device in the satisfaction survey as they did not have access to this.|||units on a scale||Inter-Quartile Range|Median
2549591|NCT02849938|Secondary|Provider Survey|Success of connection for telemedicine visits.|3 months|Control group participants did not have data for telemedicine device use as they did not have access to this.|||Visit Connections|Visit Connections||Count of Units
2549592|NCT02849938|Primary|Frequency of In-person Health Care Encounters|Hospital day length of stay reported as the total number of hospital days in the group.|3 months||||days|||Number
2549593|NCT02849704|Secondary|Coefficient of Fat Absorption: Difference in Mean % Dietary Fat Absorption Between Groups: Subjects With CP Before and After Creon36™|The fat absorption pattern in CP subjects before and after treatment with Creon36™ will be compared. The % of dietary fat absorbed will be calculated for the CP subjects before and after the medication and compared to determine whether there is a difference in the fat absorption in the same subjects between the two time points.|72 hours|Two subjects were excluded from baseline due to inadequate dietary fat intake for a valid test, and one was excluded for inadequate stool provision. Three subjects were excluded at follow up for inadequate dietary information and stool provision. One subject was excluded from follow up due to lab error.|||% of dietary fat intake||Standard Deviation|Mean
2549594|NCT02849704|Secondary|Malabsorption Blood Test: Difference in Mean HA AUC Between Groups: Subjects With CP Before and After Creon36™|The fat absorption pattern in CP subjects before and after treatment with Creon36™ will be compared. Mean HA AUC will be calculated for the CP subjects before and after the medication and compared to determine whether there is a difference in the fat absorption in the same subjects between the two time points.|8 hours|For this paired analysis, twenty subjects had valid tests at both time points. Two subjects were excluded from baseline; one did not complete the study meal for a valid test, and one was a significant outlier calling into question the validity of the test. Two subjects were excluded from follow-up, as they did not complete the study meal or test.|||mg*h/dL||Standard Deviation|Mean
2549595|NCT02849704|Secondary|Bomb Calorimetry: Difference in Mean Energy Loss Between Groups: Subjects With CP Before and After Creon36™|The energy absorption pattern in CP subjects before and after treatment with Creon36™ will be compared. Calories per gram of stool will be calculated for the CP subjects before and after the medication and compared to determine whether there is a difference in the stool energy loss in the same subjects between the two time points.|72 hours|Two subjects were excluded from follow-up due to inadequate stool provision. Two subjects were excluded due to failing the internal validation protocol.|||calories/gram of stool||Standard Deviation|Mean
2549596|NCT02849704|Primary|Bomb Calorimetry: Difference in Mean Stool Energy Loss Between Groups: Subjects With CP Compared to Healthy Subjects|The energy absorption pattern in CP subjects will be compared with healthy controls. Mean calories per gram of stool will be calculated for the CP subjects and the healthy controls and compared to determine whether there is a difference in the stool energy loss between the two groups.|72 hours|Three subjects with CP were excluded; two did not consume enough fat for a valid test, one subject did not have adequate stool for analysis. Of the 24 healthy controls, two were excluded from the analysis due to undisclosed chronic disease, one did not provide adequate stool for analysis, and two results failed internal the validation protocol.|||calories/gram of stool||Standard Deviation|Mean
2549597|NCT02849704|Primary|Coefficient of Fat Absorption: Difference in Mean % Dietary Fat Absorption Between Groups: Subjects With CP Compared to Healthy Subjects|The fat absorption pattern in CP subjects will be compared with healthy controls. Mean coefficient of fat absorption (% dietary fat absorbed) will be calculated for the CP subjects and the healthy controls and compared to determine whether there is a difference in the fat absorption between the two groups.|72 hours|Four subjects with CP were excluded; two did not consume enough fat for a valid test, one subject did not have adequate stool for analysis, and one subject was excluded due to an error in the lab processing stool. Of the 24 healthy controls, two were excluded from the analysis due to undisclosed chronic disease.|||% of dietary fat intake||Standard Deviation|Mean
2549598|NCT02849704|Primary|Malabsorption Blood Test: Difference in Mean HA AUC Between Groups: Subjects With CP Compared to Healthy Subjects|The fat absorption pattern in CP subjects will be compared with healthy controls. Mean HA AUC will be calculated for the CP subjects and the healthy controls and compared to determine whether there is a difference in the fat absorption between the two groups.|8 hours|Two subjects with CP were excluded; one did not complete the study meal for a valid test, and one was a significant outlier calling into question the validity of the test. Of the 24 healthy controls, two were excluded from the study due to undisclosed chronic disease, and two subjects did not complete the study meal for a valid test.|||mg*h/dL||Standard Deviation|Mean
2549599|NCT02849678|Secondary|Consumption of Nerve Block Boluses Will Also be Recorded Daily|During the hospitalization following surgery until discontinuation of the block or discharge. Hospital length of stay ranged from 3 - 22 days following surgery.|During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)|6 participants assigned to Group Lopi, 3 to Group Lido were not included in this analysis for the following reasons: 1 required mechanical ventilation post-op, 1 was excluded due to changes in surgical procedure, 2 patients did not complete PCA regimen, and technical issues with block excluded 5 patients from analysis.|||milliliters||Full Range|Median
2549662|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo / GSK1358820 200 U|CIC was used to drain the bladder and manage urinary incontinence in participants who were not able to spontaneously void. Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.|Up to 48 weeks after 1st treatment|Safety Population 1|||Participants|||Count of Participants
2549600|NCT02849678|Secondary|Postoperative Opioid Consumption (Milligrams of Dilaudid or Equivalent)|During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.|During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)|6 participants assigned to Group Ropi, 3 to Group Lido were not included in this analysis for the following reasons: 1 required mechanical ventilation post-op, 1 was excluded due to changes in surgical procedure, 2 patients did not complete PCA regimen, and technical issues with block excluded 5 patients from analysis.|||Milligrams||Full Range|Mean
2549601|NCT02849678|Secondary|Number of Patients With Complications (Including But Not Limited to Pneumonia, Atelectasis, Hypotension, Motor Weakness, Etc.)|During the hospitalization following surgery until discharge.|During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)||||Participants|||Count of Participants
2549602|NCT02849678|Secondary|Hospital Length of Stay.|During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.|During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)|6 participants assigned to Group Lopi, 3 to Group Lido were not included in this analysis for the following reasons: 1 required mechanical ventilation post-op, 1 was excluded due to changes in surgical procedure, 2 patients did not complete PCA regimen, and technical issues with block excluded 5 patients from analysis.|||days||Full Range|Median
2549603|NCT02849678|Secondary|Time to First Flatus/Defecation|During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.|During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)||||Postoperative days||Full Range|Median
2549604|NCT02849678|Secondary|Time to First Ambulation(Walking Greater Than 15 Feet)|During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.|During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)|6 participants assigned to Group Ropi, 3 to Group Lido were not included in this analysis for the following reasons: 1 required mechanical ventilation post-op, 1 was excluded due to changes in surgical procedure, 2 patients did not complete PCA regimen, technical issues with block excluded 5 patients from analysis (considered protocol violations).|||days||Full Range|Median
2549605|NCT02849678|Primary|11-point Verbal Numerical Rating Scale (NRS) Pain Assessment|The primary outcome of the study is the NRS score for pain at rest at 24 hours. The NRS Pain Assessment requires patients to select a number between 0 - 10 where 0 is no pain and 10 is the worst imaginable pain. Patients pick one whole number on this scale to describe their pain.|24 hours from the end of surgery|Patients undergoing elective laparoscopic bowel surgery with bilateral thoracic paravertebral continuous nerve blocks.|||Scores on a scale||Full Range|Median
2549606|NCT02849626|Secondary|Percentage of Participants With Clinical Global Impression of Change Scores (CGIC)- Core Phase and Extension Phase A of This Study|Assessment of disease severity utilized the CGIC scale at end of treatment to evaluate participant's change in disease status from baseline. The CGIC is a 7-point scale that measures a physician's global impression of a participant's clinical condition. Scale ranged from 1 to 7 with lower score indicated improvement (1=very much improved, 2=much improved, 3=minimally improved), higher score indicated worsening (5=minimally worse, 6= much worse, 7=very much worse), and a score of 4 indicated no change.|Baseline, Week 23, Week 52|FAS included participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement.|||percentage of participants|||Number
2549607|NCT02849626|Secondary|Percentage of Participants Who Were Seizure-free- Core Phase and Extension Phase A of This Study|Participants were considered seizure free if participants completed a 13-week time period and were seizure-free for that entire time period. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with SG. Data for this outcome measure has been reported for 13 week time periods as per age groups.|Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52|FAS included participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement.|||percentage of participants|||Number
2549608|NCT02849626|Secondary|Percentage of Participants Based on 75% Responder Rate- Core Phase and Extension Phase A of This Study|A 75% responder was a participant who experienced a 75% or greater reduction in seizure frequency per 28 days from baseline. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with SG. Data for this outcome measure has been reported for 13 week time periods as per age groups.|Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52|FAS included participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement.|||percentage of participants|||Number
2549609|NCT02849626|Secondary|Percentage of Participants Based on 50% Responder Rate- Core Phase and Extension Phase A of This Study|A 50% responder was a participant who experienced a 50% or greater reduction in seizure frequency per 28 days from baseline. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with SG. Data for this outcome measure has been reported for 13 week time periods as per age groups.|Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52|FAS included participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement.|||percentage of participants|||Number
2549610|NCT02849626|Secondary|Percentage of Participants Based on 25% Responder Rate- Core Phase and Extension Phase A of This Study|A 25% responder was a participant who experienced a 25% or greater reduction in seizure frequency per 28 days from baseline. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with SG. Data for this outcome measure has been reported for 13 week time periods as per age groups.|Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52|FAS included participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement.|||percentage of participants|||Number
2549840|NCT02847858|Secondary|Percentage of Participants Who Report Discussing Birth Control With Health Care Provider at Visit (Aim 2b)|The single yes/no item was self-administered in an online survey|Post-visit Follow-up (48 hours after Baseline)|All participants who completed the item at Post-visit Follow-up (48 hours post-visit)|||Participants|||Count of Participants
2549611|NCT02849626|Secondary|Median Percent Change in Seizure Frequency Per 28 Days During the Treatment Phase Relative to the Pretreatment Phase (Baseline)- Core Phase and Extension Phase A of This Study|Seizure frequency was based on number of seizures per 28 days, calculated as number of seizures over entire time interval divided by number of days in interval and multiplied by 28. Total POS: sum of all POS including simple partial seizures without motor signs, simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with secondary generalization (SG). Data for this measure has been reported for 13 week time periods as per age groups.|Baseline, Weeks 1-13, Weeks 14-26, Weeks 27-39, Weeks 40-52|Full Analysis Set (FAS) included participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement.|||percent change||Full Range|Median
2549612|NCT02849626|Secondary|Percentage of Participants With Shift From Baseline in Suicidal Ideation and Behaviors Assessed Using C-SSRS Scores to Extension Phase A (Week 52) of This Study|"The C-SSRS: interview-based instrument to systematically assess suicidal ideation (SI) and suicidal behavior, to assess whether participant experienced any of the following: completed suicide, suicide attempt (response of yes on actual attempt), preparatory acts toward imminent suicidal behavior (yes on preparatory acts or behavior, aborted attempt or interrupted attempt), suicidal ideation (yes on wish to be dead, non-specific active suicidal thoughts, active SI with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any self-injurious behavior with no suicidal intent (yes on has participant engaged in non-suicidal self-injurious behavior). w/ refers to with, W refers to Week and & refers to and"|Up to 52 weeks|SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here “Overall number of participants analyzed” signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2549613|NCT02849626|Secondary|Percentage of Participants With Any Treatment-emergent Reports of Suicidal Ideation and Behavior Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)- Core Phase and Extension Phase A of This Study|"The C-SSRS: interview-based instrument to systematically assess suicidal ideation (SI) and suicidal behavior, to assess whether participant experienced any of the following: completed suicide, suicide attempt (response of yes on actual attempt), preparatory acts toward imminent suicidal behavior (yes on preparatory acts or behavior, aborted attempt or interrupted attempt), suicidal ideation (yes on wish to be dead, non-specific active suicidal thoughts, active SI with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any self-injurious behavior with no suicidal intent (yes on has participant engaged in non-suicidal self-injurious behavior). Here, percentage of participants with >=1 positive behavior, participants with >=1 positive ideations, and suicidality were reported. An assessment of SI and behavior using the C-SSRS was performed for participants >=6 years at the time of consent."|Up to 52 weeks|SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here “Overall number of participants analyzed” signifies participants who were evaluable for this measure.|||percentage of participants|||Number
2549614|NCT02849626|Secondary|Number of Encephalogram (EEG) Abnormalities During Awake and Sleep State for Total Group of Participant: Core Phase and Extension Phase A of This Study||Baseline up to 52 weeks|SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||EEG abnormality|||Number
2549615|NCT02849626|Secondary|Percentage of Participants With Change From Baseline in Markedly Abnormal Encephalogram (EEG) Parameter Values During Awake and Sleep State for Total Group of Participant: Core Phase and Extension Phase A of This Study||Baseline up to 52 weeks|SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||percentage of participants|||Number
2549616|NCT02849626|Secondary|Change From Baseline in Insulin-like Growth Factor-1 (IGF-1) Values (a Growth and Development Parameter) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study||Baseline, Week 23, Week 52|SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||nanomoles per liter (nmol/L)||Standard Deviation|Mean
2549617|NCT02849626|Secondary|Change From Baseline in Thyroxine, Free and Triiodothyronine, Free Values (Growth and Development Parameters) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study||Baseline, Week 23, Week 52|SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||picomoles per liter (pmol/L)||Standard Deviation|Mean
2549618|NCT02849626|Secondary|Change From Baseline in Thyrotropin Value (a Growth and Development Parameter) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study|Thyrotropin level was measured in milli-international units per liter (mIU/L).|Baseline, Week 23, Week 52|SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||mIU/L||Standard Deviation|Mean
2549619|NCT02849626|Secondary|Change From Baseline in Weight (a Growth and Development Parameter) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study||Baseline, Week 23, Week 52|SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||kilogram (kg)||Standard Deviation|Mean
2549620|NCT02849626|Secondary|Change From Baseline in Height (a Growth and Development Parameter) at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study||Baseline, Week 23, Week 52|SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||centimeter (cm)||Standard Deviation|Mean
2549658|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination|The kidney and bladder ultrasound study was performed according to the study schedule. In order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants were excluded from this study if the screening ultrasound demonstrated the presence of bladder stones. In the case of unclear findings in an ultrasound study, other diagnostic measures (e.g., x-ray) was required in order to confirm the presence of bladder stones. If a stone was detected in participants after the injection of the investigational product, the event was recorded as an adverse event.|Up to Week 48 in Treatment Cycle 1|SPDB Population|||Participants|||Count of Participants
2553528|NCT02774798|Primary|Opening Pressure|The pressure (in cmH20) at which the anal canl just begins to open|at specific time point of measurement up to 1 hour||||cmH20||Standard Deviation|Mean
2549621|NCT02849626|Secondary|Change From Baseline in Time to Complete Lafayette Grooved Pegboard Test (LGPT) Scores Over 8 Years as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study|The LGPT test measured visuomotor skills. This test was a manipulative dexterity test that consisted of a metal matrix of 25 holes with randomly positioned slots. The participant was required to insert 25 grooved pegs into the holes. The task was completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task was timed and the scores were the time taken for the participant to complete all 25 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds were recorded for the time. An increase in score (longer time) indicated worsening of visuomotor skills. The time to complete test is presented as mean seconds +/- SD.|Baseline, Week 23, Week 52|"SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure."|||seconds||Standard Deviation|Mean
2549622|NCT02849626|Secondary|Change From Baseline in Time to Complete Lafayette Grooved Pegboard Test (LGPT) Scores for 8 Years and Under as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study|The LGPT test measured visuomotor skills. This test was a manipulative dexterity test that consisted of a metal matrix of 25 holes with randomly positioned slots. The participant was required to insert 10 grooved pegs into the holes. The task was completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task was timed and the scores were the time taken for the participant to complete all 10 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds were recorded for the time. An increase in score (longer time) indicated worsening of visuomotor skills. The time to complete test is presented as mean seconds plus/minus (+/-) SD.|Baseline, Week 23, Week 52|"SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure."|||seconds||Standard Deviation|Mean
2549623|NCT02849626|Secondary|Change From Baseline in Total Child Behavior Check List (CBCL) Score (Age Group 6 to 18 Years) as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study|The CBCL for participants (age group 6 to 18 years) is a questionnaire to assess behavioral and emotional problems in children as reported by the primary caregiver for the following domains activities: activity, social, school, total competence, anxious/depressed, withdrawn/depressed, somatic complaints, internalizing, rule-breaking behavior, aggressive behavior, externalizing, social problems, thought problems, attention problems. CBCL total score for participants (age group 6 to 18 years) ranged from 0 to 240, was calculated by adding individual score of each domain. Higher scores indicate greater problems in child behavior.|Baseline, Week 23, Week 52|"SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure."|||score on a scale||Standard Deviation|Mean
2549624|NCT02849626|Secondary|Change From Baseline in Total Child Behavior Check List (CBCL) Score (Age Group 1.5 to 5 Years) as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study|The CBCL for participants (age group 1.5 to 5 years) is a questionnaire to assess behavioral and emotional problems in children as reported by the primary caregiver for the following domains activities: emotionally reactive, anxious/depressed, withdrawn, somatic complaints, internalizing, attention problems, aggressive behavior, externalizing, sleep problems. CBCL total score for participants (age group 1.5 to 5 years) ranged from 0 to 200, was calculated by adding individual score of each domain. Higher scores indicate greater problems in child behavior.|Baseline, Week 23, Week 52|"SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure."|||score on a scale||Standard Deviation|Mean
2549625|NCT02849626|Secondary|Change From Baseline in Aldenkamp-Baker Neuropsychological Assessment Schedule (ABNAS) Score as Per Seizure Type at Week 23 (Core Phase) and at Week 52 (Extension Phase A) of This Study|The ABNAS assessment measured 5 aspects of cognitive function such as fatigue, memory, concentration, motor speed, and reading. The assessment was a measure of participant-perceived cognitive effects of AEDs. This instrument was aimed at assessing participant perceived drug-related cognitive impairment. Total score ranged from 0-72. Higher scores indicate a worsening of these cognitive functions.|Baseline, Week 23, Week 52|SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||score on a scale||Standard Deviation|Mean
2549626|NCT02849626|Secondary|Percentage of Participants With Most Frequent Treatment Emergent Adverse Events (AEs) for Total Group of Participants That Were Considered Related to Perampanel- Core Phase of This Study||Baseline up to 23 weeks|SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||percentage of participants|||Number
2549627|NCT02849626|Secondary|Model Predicted Change From Baseline in Total Time to Complete LGPT Score for Non-dominant Hand in Core Phase of This Study for All Participants Aged 4 to <12 Years: Assessment Based on Relationship With Plasma Levels of Perampanel|The Lafayette Grooved Pegboard Test (LGPT) measures visuomotor skills. This test is a manipulative dexterity test that consist of a metal matrix of 25 holes with randomly positioned slots. Participants require to insert 10 grooved pegs into the holes. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task is timed and the scores are the time taken for the participant to complete all 10 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds are recorded for the time. An increase in score (longer time) indicate worsening of visuomotor skills. Analysis for this outcome measure was planned to be performed via PK/PD modelling only if a graphical relationship between perampanel exposure and change from baseline in Total Time to Complete LGPT Score for Non-dominant Hand could be discerned.|Baseline up to Week 23|All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Here “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure.|||seconds||Standard Deviation|Mean
2549932|NCT02846792|Secondary|Progression Free Survival|Assessed using Response Evaluation Criteria in Solid Tumors version 1.1.|Time between receipt of first study drug until disease progression date, unacceptable toxicity or withdrawal of patient consent, assessed up to 16 months|Study terminated (stopped prematurely). Immunotherapy approved for NSCLC in the first line setting.||||||
2549628|NCT02849626|Secondary|Model Predicted Change From Baseline in Total Time to Complete LGPT Score for Dominant Hand in Core Phase of This Study for All Participants Aged 4 to <12 Years: Assessment Based on Relationship With Plasma Levels of Perampanel|The Lafayette Grooved Pegboard Test (LGPT) measures visuomotor skills. This test is a manipulative dexterity test that consist of a metal matrix of 25 holes with randomly positioned slots. Participants require to insert 10 grooved pegs into the holes. The task needs to be completed once for each hand; firstly, using the dominant hand followed by the non-dominant hand. The task is timed and the scores are the time taken for the participant to complete all 10 pegs for each hand. If the test cannot be completed within 300 seconds, 300 seconds are recorded for the time. An increase in score (longer time) indicate worsening of visuomotor skills. Analysis for this outcome measure was planned to be performed via PK/PD modelling only if a graphical relationship between perampanel exposure and change from baseline in Total Time to Complete LGPT Score for Dominant Hand could be discerned.|Baseline up to Week 23|All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Here “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure.|||seconds||Standard Deviation|Mean
2549629|NCT02849626|Secondary|Model Predicted Change From Baseline in Total Child Behavior Check List (CBCL) Score (Participants Aged Greater Than [>] 5 to <12 Years) During Core Phase of This Study: Assessment Based on Relationship With Plasma Levels of Perampanel|The CBCL for participants with age >5 to <12 years is a questionnaire to assess behavioral and emotional problems in children as reported by the primary caregiver for the following domains activities: activity, social, school, total competence, anxious/depressed, withdrawn/depressed, somatic complaints, internalizing, rule-breaking behavior, aggressive behavior, externalizing, social problems, thought problems, attention problems. CBCL total score for participants with age >5 to <12 years ranged from 0 to 240, was calculated by adding individual score of each domain. Higher scores indicate greater problems in child behavior. Analysis for this outcome measure was planned to be performed via PK/PD modelling only if a graphical relationship between perampanel exposure and change from baseline in CBCL score (participants aged >5 to <12 years) could be discerned.|Baseline up to Week 23|All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Here “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure.|||score on a scale||Standard Deviation|Mean
2549630|NCT02849626|Secondary|Model Predicted Change From Baseline in Total Child Behavior Check List (CBCL) Score (Participants Aged 4 to 5 Years) During Core Phase of This Study: Assessment Based on Relationship With Plasma Levels of Perampanel|The CBCL for participants with age 4 to 5 years is a questionnaire to assess behavioral and emotional problems in children as reported by the primary caregiver for the following domains activities: emotionally reactive, anxious/depressed, withdrawn, somatic complaints, internalizing, attention problems, aggressive behavior, externalizing, sleep problems. CBCL total score for participants with age 4 to 5 years ranged from 0 to 200, was calculated by adding individual score of each domain. Higher scores indicate greater problems in child behavior. Analysis for this outcome measure was planned to be performed via PK/PD modelling only if a graphical relationship between perampanel exposure and change from baseline in CBCL score (participants aged 4 to 5 years) could be discerned.|Baseline up to Week 23|All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Here “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure.|||score on a scale||Standard Deviation|Mean
2549631|NCT02849626|Secondary|Model Predicted Change From Baseline in Total Aldenkamp-Baker Neuropsychological Assessment Schedule (ABNAS) Score During Core Phase of This Study: Assessment Based on Relationship With Plasma Levels of Perampanel|The ABNAS assessment measured 5 aspects of cognitive function such as fatigue, memory, concentration, motor speed, and reading. The assessment was a measure of participant-perceived cognitive effects of AEDs. This instrument was aimed at assessing participant perceived drug-related cognitive impairment. Total score ranged from 0-72. Higher scores indicate a worsening of these cognitive functions. Analysis for this outcome measure was planned to be performed via Pharmacokinetic/Pharmacodynamic (PK/PD) modelling only if a graphical relationship between perampanel exposure and change from baseline in ABNAS could be discerned.|Baseline up to Week 23|All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Here “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure.|||score on a scale||Standard Deviation|Mean
2549632|NCT02849626|Secondary|Number of Seizure Free Observations During Core Phase of This Study: Assessment Based on Relationship With Average Steady State Plasma Concentration (Cav, ss) of Perampanel|"Due to the sparse PK sampling in this study, the data of this outcome measure were analyzed by pooling data from other Phase II and III studies of perampanel along with this current study, including participants with POS or PGTC. Data for this outcome measure have been reported in relationship with different ranges of Cav, ss of Perampanel as number of observations those were seizure free for up to 3 visits. The reason for using number of observations for analysis of this outcome measure was because data were available as up to 3 visits per participant and not necessarily that the participant was seizure-free on all three visits."|Baseline up to Week 23|All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Population for this measure included participants from other studies as well participants from this current study. Here “Overall number of participants analyzed” signifies participants who were evaluable for this measure.|||Seizure free observations|Seizure free observations||Count of Units
2549659|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 200 U / GSK1358820 200 U|CIC was used to drain the bladder and manage urinary incontinence in participants who were not able to spontaneously void. Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.|Up to 48 weeks after 1st treatment|Safety Population 3|||Participants|||Count of Participants
2549660|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo / GSK1358820 200 U|CIC was used to drain the bladder and manage urinary incontinence in participants who were not able to spontaneously void. Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.|Up to 48 weeks after 1st treatment|Safety Population 2|||Participants|||Count of Participants
2549633|NCT02849626|Secondary|Overall Responder Probability For Participants With PGTC Seizures During Core Phase of This Study: Assessment Based on Relationship With Average Steady State Plasma Concentration (Cav, ss) of Perampanel|For this outcome measure, responders were those who experienced a 50% or greater reduction in seizure frequency per 28 days from baseline. Due to the sparse PK sampling in this study, the data of this outcome measure were analyzed by pooling the data from other Phase II and III studies of perampanel along with data of this current study, including participants with PGTC seizures. In this outcome measure, responder probability at different concentration values of perampanel when given with or without topiramate (an antiepileptic) has been reported.|Baseline up to 23 weeks|"All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Population for this measure included participants from other studies as well participants from this current study. Here Overall number of participants analyzed” signifies participants who were evaluable for this measure."|||Responder probability|||Number
2549634|NCT02849626|Secondary|Overall Responder Probability For Non-Asian Participants With POS During Core Phase of This Study: Assessment Based on Relationship With Average Steady State Plasma Concentration (Cav, ss) of Perampanel|"For this outcome measure, responders were those who experienced a 50 percent (%) or greater reduction in seizure frequency per 28 days from baseline. Due to the sparse PK sampling in this study, the data of this outcome measure were pooled with data from other Phase III studies of perampanel conducted in participants with POS. AEDs not affecting PK refers to AEDs not affecting PK of perampanel. Data for this outcome measure has been reported for only non-Asian participants with POS per age groups. Responder probability has been reported for Cav,ss of perampanel when given along with different antiepileptic drugs (AEDs)."|Baseline up to 23 weeks|"All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Population for this measure included participants from other studies as well participants from this current study. Here overall number of participants analyzed” signifies participants who were evaluable for this measure."|||Responder probability|||Number
2549635|NCT02849626|Secondary|Model Predicted Percent Change in Average Seizure Frequency Over 28 Days During Maintenance Period in Core Phase of This Study From Baseline- Assessed as Relationship With Average Steady State Plasma Concentration (Cav, ss) of Perampanel (518 ng/mL)|"Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. Due to the sparse pharmacokinetic (PK) sampling in this study, the data of this outcome measure was analyzed by pooling the data from other Phase II and III studies of perampanel along with the data of this current study, including participants with POS or PGTC. Only data for participants taking perampanel 8 mg/day (corresponding to Cav, ss of 518 ng/mL) were reported. Participants taking perampanel 12 mg/day in the studies from which data were pooled, were not included in analysis for this measure. Here, ng/mL refers to nanogram per milliliter. Data for this measure was calculated through model prediction and reported as percent change with measure type as number and measure dispersion as Not applicable, NA."|Baseline, Week 23|All participants who received perampanel who have seizure frequency, cognition, or AE data with documented dosing history. Population for this measure included participants from other studies as well participants from this current study. Here “overall number of participants analyzed” signifies participants who were evaluable for this measure.|||percent change|||Number
2549636|NCT02849626|Primary|Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Parameters for Total Group of Participants- Core Phase and Extension Phase A of This Study||Baseline up to 52 weeks|"SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2549637|NCT02849626|Primary|Percentage of Participants With Abnormal Vital Sign Values for Total Group of Participants- Core Phase and Extension Phase A of This Study|Pre-defined criteria of vital signs abnormalities: maximum (max.) increase or decrease from baseline in sitting/supine systolic blood pressure (SBP) of greater than or equal to (>=) 20 or 40 millimeter of mercury (mmHg); maximum increase or decrease from baseline in sitting/supine diastolic blood pressure (DBP) >=10 or 20 mmHg; increase or decrease from baseline in pulse rate (number of heart beats per minute [bpm]) of >=15 or 30 bpm. Data for this outcome measure has been assessed and reported till Week 52.|Baseline up to 52 weeks|"SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2549638|NCT02849626|Primary|Percentage of Participants With Treatment Emergent Markedly Abnormal Laboratory Values for Total Group of Participants- Core Phase and Extension Phase A of This Study||Baseline up to 52 weeks|SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||percentage of participants|||Number
2549639|NCT02849626|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) for Total Group of Participants- Core Phase and Extension Phase A of This Study||Baseline up to 4 weeks (follow up in Extension Phase A) after last dose of study drug in Extension Phase A at Week 52 (up to 56 weeks)|SAS included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||percentage of participants|||Number
2549640|NCT02849509|Secondary|Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B|"For Cohort B, scores of PACT-Q1 at baseline were summarised descriptively.~The PACT-Q1 is composed of a single dimension (7 items) covering the expectations of patients regarding their anticoagulant treatment and is to be administered before treatment initiation.~The PACT-Q1 scores ranged from 1 (Not at all) to 5 (Extremely/Completely/ Very much)."|Baseline (Visit1)|The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries. PACT-Q1 data which were collected after the first dose or using incorrect procedure were excluded from the summary.|||Unit on scale||Standard Deviation|Mean
2550156|NCT02839876|Secondary|Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)|Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).|24 hours||||score on a scale||Inter-Quartile Range|Median
2549641|NCT02849509|Secondary|Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment|"Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to second assessment.~The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items).~The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3)were compared with the second assessment (Visit 2). Within the PACT-Q2, items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction score."|Second assessment - Visit 2 (7-124 days after initiation on Pradaxa or VKA) and last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA)|The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.|||Unit on scale||Standard Deviation|Mean
2549642|NCT02849509|Primary|Patient Characteristics at Baseline - Duration of Previous VKA Treatment for Cohort A|Duration of continuous VKA treatment for stroke prevention prior to baseline assessment (Cohort A)|Baseline (Visit1)|Eligible patients who took the prescribed treatment and without an important protocol violation|||Years||Standard Deviation|Mean
2549643|NCT02849509|Secondary|Patient Characteristics at Baseline - Creatinine Clearance|Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.|Baseline (Visit1)|Eligible patients who took the prescribed treatment and without an important protocol violation|||mL/min||Standard Deviation|Mean
2549644|NCT02849509|Secondary|Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score|"HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol.~HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome."|Baseline (Visit1)|Eligible patients who took the prescribed treatment and without an important protocol violation|||unit on scale||Standard Deviation|Mean
2549645|NCT02849509|Secondary|Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score|"CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category.~CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome."|Baseline (Visit1)|Eligible patients who took the prescribed treatment and without an important protocol violation|||unit on scale||Standard Deviation|Mean
2549646|NCT02849509|Primary|Patient Characterization at Baseline - Categorical Parameters|Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP).|Baseline (Visit1)|Eligible patients who took the prescribed treatment and without an important protocol violation|||Percentage of participant|||Number
2549647|NCT02849509|Primary|Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups|"Mean PACT-Q2 scores, for patients in cohort B, at last assessment compared between treatment groups.~Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome.~Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the last assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement."|Last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA)|The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries and propensity score matched patients.|||Unit on scale||Standard Deviation|Mean
2549648|NCT02849509|Primary|Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups|"Mean PACT-Q2 scores, for patients in cohort B, at second assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome.~Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement.~PACT−Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis."|Second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)|The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries and propensity score matched patients.|||Unit on scale||Standard Deviation|Mean
2549649|NCT02849509|Primary|Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment|"Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to baseline assessment. The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). Within the PACT-Q2, items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction score. High scores are more favorable.~PACT−Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis."|Visit 1 (Baseline) and last assessment Visit 3 (125-365 days after initiation on Pradaxa or VKA)|The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.|||Unit on scale||Standard Deviation|Mean
2550157|NCT02839876|Secondary|Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)|Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).|8 hours||||score on a scale||Inter-Quartile Range|Median
2549650|NCT02849509|Primary|Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment|"Mean Perception of Anticoagulant treatment Questionnaire, part 2 (PACT-Q2) scores, for patients in cohort A, at second assessment compared to baseline assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease & treatment (2 items), & anticoagulant treatment satisfaction (7 items). In this outcome the mean convenience & satisfaction dimension scores of PACT-Q2 at second assessment (Visit 2) were compared with baseline assessment (Visit 1). Within the PACT-Q2, items for convenience & for burden of disease and treatment were reversed (reversed score = 6 - item score), added together & rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed & rescaled on 0-100 scale to determine satisfaction score. High scores are more favorable.~PACT−Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from analysis."|Visit 1 (Baseline) and second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)|The main analysis population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.|||Unit on scale||Standard Deviation|Mean
2549651|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With A-NCS and A-CS ECG Findings|Single 12-lead ECGs were obtained at each timepoint during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT. The findings from ECG were classified as A-NCS and A-CS. Number of participants with A-NCS and A-CS findings have been reported.|Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3|Safety Population 1. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2549652|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With A-NCS and A-CS ECG Findings|Single 12-lead ECGs were obtained at each timepoint during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT. The findings from ECG were classified as A-NCS and A-CS. Number of participants with A-NCS and A-CS findings have been reported.|Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2|Safety Population 1. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2549653|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Abnormal Not Clinically Significant (A-NCS) and Abnormal Clinically Significant (A-CS) Electrocardiogram (ECG) Findings|Single 12-lead ECGs were obtained at each timepoint during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals. The findings from ECG were classified as A-NCS and A-CS. Number of participants with A-NCS and A-CS findings have been reported.|Baseline (Pre-dose on Day 1), Week 12 and Week 48 in Treatment Cycle 1|SPDB Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2549654|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: GSK1358820 200 U / GSK1358820 200 U|CIC was used to drain the bladder and manage urinary incontinence in participants who were not able to spontaneously void. Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.|Up to 48 weeks after 1st treatment|Safety Population 3|||Participants|||Count of Participants
2549655|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: Placebo / GSK1358820 200 U|The kidney and bladder ultrasound study was performed according to the study schedule. In order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants were excluded from this study if the screening ultrasound demonstrated the presence of bladder stones. In the case of unclear findings in an ultrasound study, other diagnostic measures (e.g., x-ray) was required in order to confirm the presence of bladder stones. If a stone was detected in participants after the injection of the investigational product, the event was recorded as an adverse event.|Up to 48 weeks after 1st treatment|Safety Population 2|||Participants|||Count of Participants
2549656|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: GSK1358820 200 U / GSK1358820 200 U|The kidney and bladder ultrasound study was performed according to the study schedule. In order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants were excluded from this study if the screening ultrasound demonstrated the presence of bladder stones. In the case of unclear findings in an ultrasound study, other diagnostic measures (e.g., x-ray) was required in order to confirm the presence of bladder stones. If a stone was detected in participants after the injection of the investigational product, the event was recorded as an adverse event.|Up to 48 weeks after 1st treatment|Safety Population 2|||Participants|||Count of Participants
2549657|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings in Kidney and Bladder Ultrasound Examination: Placebo / GSK1358820 200 U|The kidney and bladder ultrasound study was performed according to the study schedule. In order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants were excluded from this study if the screening ultrasound demonstrated the presence of bladder stones. In the case of unclear findings in an ultrasound study, other diagnostic measures (e.g., x-ray) was required in order to confirm the presence of bladder stones. If a stone was detected in participants after the injection of the investigational product, the event was recorded as an adverse event.|Up to 48 weeks after 1st treatment|Safety Population 1|||Participants|||Count of Participants
2549661|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 200 U / GSK1358820 200 U|CIC was used to drain the bladder and manage urinary incontinence in participants who were not able to spontaneously void. Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.|Up to 48 weeks after 1st treatment|Safety Population 2|||Participants|||Count of Participants
2567179|NCT02570074|Secondary|Urinary Bactericidal (UBT) Titers for E. Coli ATCC BAA-2323|UBT for E. Coli ATCC BAA-2323|24 hours on Day 1 and Day 5||||Reciprocal Titers||Inter-Quartile Range|Median
2549663|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Number of Participants Using CIC for Urinary Retention or Elevated PVR|CIC was used to drain the bladder and manage urinary incontinence in participants who were not able to spontaneously void. Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.|Up to Week 48 in Treatment Cycle 1|SPDB Population|||Participants|||Count of Participants
2549664|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U|PVR was measured in non-catheterizing participants, or those with mixed patterns (ie, they do both CIC and spontaneous voiding). PVR urine volume was assessed by ultrasound, bladder scan or catheterization after participants performed a voluntary void according to the study schedule. PVR urine volume could be assessed at any other time depending on clinical need. In case PVR urine volume indicated a clinically meaningful elevation, participants were asked to void once again (allowing the participants sufficient time to void) and the PVR urine volume was then reassessed. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Individual participant data has been presented.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 3|Safety Population 3. Only those participants with data available at the specified data points were analyzed.|||Milliliter|||Number
2549665|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U|PVR was measured in non-catheterizing participants, or those with mixed patterns (ie, they do both CIC and spontaneous voiding). PVR urine volume was assessed by ultrasound, bladder scan or catheterization after participants performed a voluntary void according to the study schedule. PVR urine volume could be assessed at any other time depending on clinical need. In case PVR urine volume indicated a clinically meaningful elevation, participants were asked to void once again (allowing the participants sufficient time to void) and the PVR urine volume was then reassessed. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Individual participant data has been presented.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 3|Safety Population 2. Only those participants with data available at the specified data points were analyzed.|||Milliliter|||Number
2549666|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 200 U / GSK1358820 200 U|PVR was measured in non-catheterizing participants, or those with mixed patterns (ie, they do both CIC and spontaneous voiding). PVR urine volume was assessed by ultrasound, bladder scan or catheterization after participants performed a voluntary void according to the study schedule. PVR urine volume could be assessed at any other time depending on clinical need. In case PVR urine volume indicated a clinically meaningful elevation, participants were asked to void once again (allowing the participants sufficient time to void) and the PVR urine volume was then reassessed. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Individual participant data has been presented.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 2, Week 6 and Week 12 (Study exit, Week 48 of Treatment Cycle 1) in Treatment Cycle 2|Safety Population 2. Only those participants with data available at the specified data points were analyzed.|||Milliliter|||Number
2549667|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo / GSK1358820 200 U|PVR was measured in non-catheterizing participants, or those with mixed patterns (ie, they do both CIC and spontaneous voiding). PVR urine volume was assessed by ultrasound, bladder scan or catheterization after participants performed a voluntary void according to the study schedule. PVR urine volume could be assessed at any other time depending on clinical need. In case PVR urine volume indicated a clinically meaningful elevation, participants were asked to void once again (allowing the participants sufficient time to void) and the PVR urine volume was then reassessed. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 2, Week 6 and Week 12 (Study exit, Week 48 of Treatment Cycle 1) in Treatment Cycle 2|Safety Population 1. Only those participants with data available at the specified data points were analyzed.|||Milliliter||Full Range|Median
2549668|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in PVR Urine Volume|PVR was measured in non-catheterizing participants, or those with mixed patterns (ie, they do both clean intermittent catheterization [CIC] and spontaneous voiding). PVR urine volume was assessed by ultrasound, bladder scan or catheterization after participants performed a voluntary void according to the study schedule. PVR urine volume could be assessed at any other time depending on clinical need. In case PVR urine volume indicated a clinically meaningful elevation, participants were asked to void once again (allowing the participants sufficient time to void) and the PVR urine volume was then reassessed. For participants who had a PVR urine volume measurement repeated, only the repeat value was recorded. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 24, Week 36 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1|SPDB Population. Only those participants with data available at the specified time points were analyzed.|||Milliliter||Standard Deviation|Mean
2549669|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: GSK1358820 200 U/GSK1358820 200 U|A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with >=10^5 CFU/mL and leukocyturia with >5 per high power field was noted. Number of participants with UTI undergoing urine culture and sensitivity analysis have been presented.|Up to 48 weeks after 1st treatment|Safety Population 3|||Participants|||Count of Participants
2549670|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: Placebo/GSK1358820 200 U|A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with >=10^5 CFU/mL and leukocyturia with >5 per high power field was noted. Number of participants with UTI undergoing urine culture and sensitivity analysis have been presented.|Up to 48 weeks after 1st treatment|Safety Population 2|||Participants|||Count of Participants
2567180|NCT02570074|Secondary|Urine Fosfomycin Concentrations [mg/L]|Urine Fosfomycin concentrations [mg/L]|Day 5: 24 hours||||mg/L||Standard Deviation|Mean
2549671|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: GSK1358820 200 U/GSK1358820 200 U|A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with >=10^5 CFU/mL and leukocyturia with >5 per high power field was noted. Number of participants with UTI undergoing urine culture and sensitivity analysis have been presented.|Up to 48 weeks after 1st treatment|Safety Population 2|||Participants|||Count of Participants
2549672|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: Placebo/GSK1358820 200 U|A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with >=10^5 CFU/mL and leukocyturia with >5 per high power field was noted. Number of participants with UTI undergoing urine culture and sensitivity analysis have been presented.|Up to Week 48 after 1st treatment|Safety Population 1|||Participants|||Count of Participants
2549673|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Urinary Tract Infection (UTI)|A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with >=10^5 Colony Forming Unit per milliliter (CFU/mL) and leukocyturia with >5 per high power field was noted. Number of participants with UTI undergoing urine culture and sensitivity analysis have been presented.|Up to Week 48 in Treatment Cycle 1|SPDB Population|||Participants|||Count of Participants
2549674|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis|Urinalysis parameters assessed were urine occult blood, urine protein. In this dipstick test, the level of occult blood and protein in urine samples was recorded as negative, trace, 1+, 2+, 3+ and 4+ (the plus sign increases with a higher level of occult blood or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive etc). Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst-case urinalysis results post-Baseline relative to Baseline by dipstick analysis have been presented.|Baseline (Day 1, pre-dose of Treatment Cycle 1) and up to 48 weeks after 1st treatment|Safety Population 1|||Participants|||Count of Participants
2549675|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis|Urinalysis parameters assessed were urine occult blood, urine protein. In this dipstick test, the level of occult blood and protein in urine samples was recorded as negative, trace, 1+, 2+, 3+ and 4+ (the plus sign increases with a higher level of occult blood or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive etc). Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst-case urinalysis results post-Baseline relative to Baseline by dipstick analysis have been presented.|Baseline (Day 1, pre-dose of Treatment Cycle 1) and up to 48 weeks after 1st treatment|Safety Population 1|||Participants|||Count of Participants
2549676|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Analysis|Urinalysis parameters assessed were urine occult blood, urine protein. In this dipstick test, the level of occult blood and protein in urine samples was recorded as negative, trace, 1+, 2+, 3+ and 4+ (the plus sign increases with a higher level of occult blood or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive etc). Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with worst-case urinalysis results post-Baseline relative to Baseline by dipstick analysis have been presented.|Baseline (Pre-dose on Day 1) and up to Week 48 in Treatment Cycle 1|SPDB Population|||Participants|||Count of Participants
2549677|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters|Blood samples were collected for analysis of following clinical chemistry parameters; Albumin, Alk Phosp, ALT, AST, Direct Bil, Total Bil, Calcium, Chloride, Creatinine, Glucose, Potassium, Sodium, T Protein, Urea/BUN and Uric acid. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only categories with non-zero values have been presented.|Week 12 and Week 48 (48 Weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3|Safety Population 1. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2549678|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters|Blood samples were collected for analysis of following clinical chemistry parameters; Albumin, Alk Phosp, ALT, AST, Direct Bil, Total Bil, Calcium, Chloride, Creatinine, Glucose, Potassium, Sodium, T Protein, Urea/BUN and Uric acid. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only categories with non-zero values have been presented.|Week 12 and Week 48 (48 Weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2|Safety Population 1. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2550122|NCT02839902|Secondary|Percent Changes From Baseline in Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio in Total Lipids|The reported data are percent of change from baseline in EPA/AA ratio in total lipids at Week 4 and Week 8.|Baseline, Week 4 and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||Percent of Change||Standard Deviation|Mean
2549679|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Clinical Chemistry Parameters|Blood samples were collected for analysis of following clinical chemistry parameters; Albumin, Alkaline Phosphatase (Alk Phosp), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Direct Bilirubin (Bil), Total Bil, Calcium, Chloride, Creatinine, Glucose, Potassium, Sodium, Total Protein (T Protein), Urea/blood urea nitrogen (BUN) and Uric acid. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only categories with non-zero values have been presented.|Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1|SPDB Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2549680|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline in Hematology Parameters|Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosinophils, Hb, Hct, Lympho, Monocytes, N bands, T neutro, PC, RBC count, and WBC. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only categories with non-zero values have been presented.|Week 12 and Week 48 (48 Weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3|Safety Population 1. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2549681|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline in Hematology Parameters|Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosinophils, Hb, Hct, Lympho, Monocytes, N bands, T neutro, PC, RBC count, and WBC. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only categories with non-zero values have been presented.|Week 12 and Week 48 (48 Weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2|Safety Population 1. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2549682|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Shift From Baseline in Hematology Parameters|Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosinophils, Hemoglobin (Hb), Hematocrit (Hct), Lymphocytes (Lympho), Monocytes, Neutrophil bands (N bands), Total Neutrophils (T neutro), Platelet count (PC), Red Blood Cell (RBC) count, and White Blood Cell count (WBC). Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Only categories with non-zero values have been presented.|Week 12, and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1|SPDB Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2549683|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Body Temperature|Vital sign parameter temperature was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3|Safety Population 1. Only those participants with data available at the specified time points were analyzed.|||Degree Celsius||Standard Deviation|Mean
2549684|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Body Temperature|Vital sign parameter temperature was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 24 and Week 48 (48 Weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2|Safety Population 1. Only those participants with data available at the specified time points were analyzed.|||Degree Celsius||Standard Deviation|Mean
2549685|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Body Temperature|Vital sign parameter temperature was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1|SPDB Population. Only those participants with data available at the specified time points were analyzed.|||Degree Celsius||Standard Deviation|Mean
2549753|NCT02849080|Secondary|Change in Waist Circumference- Sustainability|Change from baseline (week 0) in waist circumference was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 104|Overall number of participants analyzed = number of participants with available data.|||cm||Standard Deviation|Mean
2549686|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate|Vital sign parameter heart rate was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3|Safety Population 1. Only those participants with data available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2549687|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate|Vital sign parameter heart rate was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 24 and Week 48 (48 Weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2|Safety Population 1. Only those participants with data available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2549688|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Heart Rate|Vital sign parameter heart rate was measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1|SPDB Population. Only those participants with data available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2549689|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP|Vital sign parameter SBP and DBP were measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3|Safety Population 1. Only those participants with data available at the specified time points were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
2549690|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP|Vital sign parameter SBP and DBP were measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2|Safety Population 1. Only those participants with data available at the specified time points were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
2549691|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital sign parameter SBP and DBP were measured in seated position after 5 minutes rest. Baseline was defined as latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1|SPDB Population. Only those participants with data available at the specified time points were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
2549692|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: GSK1358820 200 U / GSK1358820 200 U|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Safety Population 3 comprised of all participants who received three doses of GSK1358820.|Up to 48 weeks after 1st treatment|Safety Population 3|||Participants|||Count of Participants
2549693|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: Placebo / GSK1358820 200 U|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to 48 weeks after 1st treatment|Safety Population 2|||Participants|||Count of Participants
2549694|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: GSK1358820 200 U / GSK1358820 200 U|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Safety Population 2 comprised of all participants who received at least two doses of GSK1358820.|Up to 48 weeks after 1st treatment|Safety Population 2|||Participants|||Count of Participants
2549695|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 200 U|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Safety population 1 comprised of all participants who received at least one dose of GSK1358820.|Up to 48 weeks after 1st treatment|Safety Population 1|||Participants|||Count of Participants
2549696|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Number of Participants With Serious Adverse Events (SAEs) and Non-SAE|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Safety for double blind phase (SPDB) Population comprised of all participants who received at least one dose of study treatment.|Up to Week 48 in Treatment Cycle 1|SPDB Population|||Participants|||Count of Participants
2549697|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants With Positive Response on TBS|TBS consisted of 4 answers to 1 question, to which participants had to answer considering their current condition (urinary problems, urinary incontinence) compared to their condition before receiving any study treatment in the trial. Responses for questions were coded as 1 to 4 where 1 - Greatly improved, 2 - Improved, 3 - Not changed and 4 - Worsened. The answers of 1 - Greatly improved or 2 - Improved were regarded as positive response. Other answers including missing data were regarded as NO positive response.|Week 0, Week 2, Week 6, Week 12, and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at the specified time points were analyzed.|||Percentage of participants|||Number
2549698|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants With Positive Response on TBS|TBS consisted of 4 answers to 1 question, to which participants had to answer considering their current condition (urinary problems, urinary incontinence) compared to their condition before receiving any study treatment in the trial. Responses for questions were coded as 1 to 4 where 1 - Greatly improved, 2 - Improved, 3 - Not changed and 4 - Worsened. The answers of 1 - Greatly improved or 2 - Improved were regarded as positive response. Other answers including missing data were regarded as NO positive response.|Week 0, Week 2, Week 6, Week 12, Week 24, and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at the specified time points were analyzed.|||Percentage of participants|||Number
2549699|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants With Positive Response on Treatment Benefit Scale (TBS)|TBS consisted of 4 answers to 1 question, to which participants had to answer considering their current condition (urinary problems, urinary incontinence) compared to their condition before receiving any study treatment in the trial. Responses for questions were coded as 1 to 4 where 1 - Greatly improved, 2 - Improved, 3 - Not changed and 4 - Worsened. The answers of 1 - Greatly improved or 2 - Improved were regarded as positive response. Other answers including missing data were regarded as NO positive response.|Week 2, Week 6 , Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1|FAS1 Population. Only those participants with data available at the specified time points were analyzed.|||Percentage of participants|||Number
2549700|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in KHQ Domain Score|KHQ is a 21 item questionnaire, consisting of 9 domains: GH (1[Very good] to 5[Very poor]), Int Imp (1[Not at all] to 4[A lot]), RL (1[Not at all] to 4[A lot]), PL (1[Not at all] to 4[A lot]), SL (0[not applicable] to 4[A lot]), PR (0[Not applicable] to 4[A lot]), Emotions (1[Not at all] to 4[Very much]), S or E (1[Never] to 4[All the time]) and S or C (1[Never] to 4[All the time]). Domain score for GH was calculated as score of one item minus 1/4x100; Int Imp: score of one item minus 1/3x100; RL, PL, PR, S or E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S or C: summed scores of 5 items minus 5/15x100. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was any visit value minus Baseline value.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 6, Week 12 and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2549701|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in KHQ Domain Score|KHQ is a 21 item questionnaire, consisting of 9 domains: GH (1[Very good] to 5[Very poor]), Int Imp (1[Not at all] to 4[A lot]), RL (1[Not at all] to 4[A lot]), PL (1[Not at all] to 4[A lot]), SL (0[not applicable] to 4[A lot]), PR (0[Not applicable] to 4[A lot]), Emotions (1[Not at all] to 4[Very much]), S or E (1[Never] to 4[All the time]) and S or C (1[Never] to 4[All the time]). Domain score for GH was calculated as score of one item minus 1/4x100; Int Imp: score of one item minus 1/3x100; RL, PL, PR, S or E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S or C: summed scores of 5 items minus 5/15x100. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was any visit value minus Baseline value.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 6, Week 12, Week 24, and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2549702|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in King's Health Questionnaire (KHQ) Domain Score|KHQ is a 21 item questionnaire, consisting of 9 domains:General health (GH) (1[Very good] to 5[Very poor]), Incontinence impact (Int Imp) (1[Not at all] to 4[A lot]), Role Limitations (RL) (1[Not at all] to 4[A lot]), Physical limitations (PL) (1[Not at all] to 4[A lot]), Social limitations (SL) (0[not applicable] to 4[A lot]), Personal relationships (PR) (0[Not applicable] to 4[A lot]), Emotions (1[Not at all] to 4[Very much]), Sleep or energy (S or E) (1[Never] to 4[All the time]) and Severity or Coping (S or C) (1[Never] to 4[All the time]). Domain score for GH was calculated as score of one item minus 1/4x100; Int Imp: score of one item minus 1/3x100; RL, PL, PR, S or E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S or C: summed scores of 5 items minus 5/15x100. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was any visit value minus Baseline value.|Baseline (Pre-dose on Day 1), Week 6, Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1|FAS1 Population. Only those participants with data available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2549703|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Time to Request for Retreatment After First Treatment|"The time taken by the participants to request re-treatment was reported. Time to the participant's first request for 2nd treatment from the day of 1st treatment was calculated as the earliest date when participants provided Yes response to the question of participants request for retreatment minus the day of first treatment plus 1."|Up to 36 Weeks in Treatment Cycle 1|FAS1 Population|||Days||95% Confidence Interval|Median
2549704|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Time to Qualification for Retreatment After First Treatment|"Participants can be considered for re-treatment beginning at the week 12 visit following the initial treatment or the week 12 visit following any re-treatment. Qualification criteria was; participants must have initiated request for re-treatment, participants experienced at least 4 episodes of urinary incontinence, with no more than one incontinence-free day, post-void residual (PVR) urine volume must have been <200 mL for participants who micturated or had a mixed catheterization / spontaneous micturition pattern, body weight >=40 kilogram; investigator deemed re-treatment appropriate. Time to the participant's first qualification for 2nd treatment from the day of 1st treatment was calculated as the earliest date when participants gave Yes response to the question of participants qualification for retreatment minus the day of first treatment plus 1."|Up to 36 Weeks in Treatment Cycle 1|FAS1 Population|||Days||95% Confidence Interval|Median
2549705|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes|Participants were instructed to enter data on the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Percentage of participants attaining 100%, >=75% and >=50% reduction from Baseline in the daily average of urinary incontinence episodes in Treatment Cycle 3 have been presented.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at the specified time points were analyzed.|||Percentage of participants|||Number
2549706|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes|Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Percentage of participants attaining 100%, >=75% and >=50% reduction from Baseline in the daily average of urinary incontinence episodes in Treatment Cycle 2 have been presented.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at the specified time points were analyzed.|||Percentage of participants|||Number
2549707|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes|Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Percentage of participants attaining 100%, >=75% and >=50% reduction from Baseline in the daily average of urinary incontinence episodes in Treatment Cycle 1 have been presented.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. Only those participants with data available at the specified time points were analyzed.|||Percentage of participants|||Number
2549708|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in Average Volume Voided Per Micturition|The total volume voided was measured and recorded by participants over one 24-hour period during the 3-day bladder diary collection period. To perform this measurement, urine collection containers provided by the sponsor were used. The volume voided per void was determined by the sponsor from the total urine volume measured by the participants divided by the number of voids (excluding urinary incontinence episode). Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2549709|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in Average Volume Voided Per Micturition|The total volume voided was measured and recorded by participants over one 24-hour period during the 3-day bladder diary collection period. To perform this measurement, urine collection containers provided by the sponsor were used. The volume voided per void was determined by the sponsor from the total urine volume measured by the participants divided by the number of voids (excluding urinary incontinence episode). Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2549841|NCT02847858|Secondary|Number of Correct Answers to 7-item Contraception Knowledge Measure (Aim 1a)|The same measure was self-administered in an online survey immediately prior to using the Health-E You app (the intervention) and then immediately after app use. The Health-E You Knowledge Scale is a 7-item true/false format with a range of 0-7, a higher score indicates a better outcome.|Immediate pre-app (Baseline), Immediate post-app (< 1 hour)|Intervention participants who used app|||Scores on a scale||Standard Deviation|Mean
2549710|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in Average Volume Voided Per Micturition|The total volume voided was measured and recorded by participants over one 24-hour period during the 3-day bladder diary collection period. To perform this measurement, urine collection containers provided by the sponsor were used. The volume voided per void was determined by the sponsor from the total urine volume measured by the participants divided by the number of voids (excluding urinary incontinence episode). Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. Only those participants with data available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2549711|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Average Volume Voided Per Micturition|The total volume voided was measured and recorded by participants over one 24-hour period during the 3-day bladder diary collection period. To perform this measurement, urine collection containers provided by the sponsor were used. The volume voided per void was determined by the sponsor from the total urine volume measured by the participants divided by the number of voids (excluding urinary incontinence episode). Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at the specified time points were analyzed.|||Milliliter||Standard Deviation|Mean
2549712|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Average Volume Voided Per Micturition|The total volume voided was measured and recorded by participants over one 24-hour period during the 3-day bladder diary collection period. To perform this measurement, urine collection containers provided by the sponsor were used. The volume voided per void was determined by the sponsor from the total urine volume measured by the participants divided by the number of voids (excluding urinary incontinence episode). Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at the specified time points were analyzed.|||Milliliter||Standard Deviation|Mean
2549713|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Average Volume Voided Per Micturition|The total volume voided was measured and recorded by participants over one 24-hour period during the 3-day bladder diary collection period. To perform this measurement, urine collection containers provided by the sponsor were used. The volume voided per void was determined by the sponsor from the total urine volume measured by the participants divided by the number of voids (excluding urinary incontinence episode). Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. Only those participants with data available at the specified time points were analyzed.|||Milliliter||Standard Deviation|Mean
2549714|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Voids|Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2549715|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Voids|Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2549752|NCT02849080|Secondary|Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Sustainability|Participants who achieved HbA1c <7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 104. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 104|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2550150|NCT02839876|Other Pre-specified|Pharmacy-related Costs|difference in pharmacy-related cost between groups|0-72 hours||||US dollars||Inter-Quartile Range|Median
2549716|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Voids|Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. Only those participants with data available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2549717|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Voids|Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at the specified time points were analyzed.|||Voids||Standard Deviation|Mean
2549718|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Voids|Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at the specified time points were analyzed.|||Voids||Standard Deviation|Mean
2549719|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Voids|Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of void episodes. Data collected from a 24-hour period with less than 2 void episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which had at least one valid diary day assessment. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. Only those participants with data available at the specified time points were analyzed.|||Voids||Standard Deviation|Mean
2549720|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes|Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2549721|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes|Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2549722|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Percent Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes|Participants were instructed to enter data on the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. Only those participants with data available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2549723|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes|Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. FAS3 comprised all randomized participants who had at least 1 post-third treatment efficacy assessment after the third treatment.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12 and Week 18 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at the specified time points were analyzed.|||Episodes||Standard Deviation|Mean
2549724|NCT02849418|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes|Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. FAS2 comprised all randomized participants who had at least 1 post-second treatment efficacy assessment after the second treatment.|Baseline (Day 1, pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at the specified time points were analyzed.|||Episodes||Standard Deviation|Mean
2549725|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes|Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. Only those participants with data available at the specified time points were analyzed.|||Episodes||Standard Deviation|Mean
2549726|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Detrusor Pressure During the Storage Phase (PdetMax) by Urodynamic Assessment at Week 6|PdetMax was calculated by urodynamic assessment according to ICS standard guidelines. Baseline was the latest pre-dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Pre-dose on Day 1) and Week 6 in Treatment Cycle 1|FAS1 Population|||cmH2O||Standard Deviation|Mean
2549727|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Volume at First IDC (VPmaxIDC) by Urodynamic Assessment at Week 6|VPmaxIDC was calculated by urodynamic assessment according to ICS standard guidelines. Baseline was the latest pre-dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Pre-dose on Day 1) and Week 6 in Treatment Cycle 1|FAS1 Population|||Milliliter||Standard Deviation|Mean
2549728|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC) (PmaxIDC) by Urodynamic Assessment at Week 6|PmaxIDC was calculated by urodynamic assessment according to ICS standard guidelines. Baseline was the latest pre-dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Pre-dose on Day 1) and Week 6 in Treatment Cycle 1|FAS1 Population. Only those participants with data available at the indicated time point were analyzed.|||Centimeter of water (cmH2O)||Standard Deviation|Mean
2549729|NCT02849418|Secondary|Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in Maximum Cystometric Capacity (MCC) by Urodynamic Assessment at Week 6|MCC was calculated by urodynamic assessment according to International Continence Society (ICS) standard guidelines. Baseline was the latest pre-dose assessment with a non-missing value. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Pre-dose on Day 1) and Week 6 in Treatment Cycle 1|FAS1 Population|||Milliliter||Standard Deviation|Mean
2549730|NCT02849418|Primary|Treatment Phase 1 (Treatment Cycle 1)- Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes at Week 6|Participants were instructed to enter data in the bladder diary over 3 consecutive days. For Baseline and post-treatment visits, analysis was based on the diary data collected during a 3-day interval for each visit. Each 3-day interval consisted of 3 consecutive 24-hour periods, with the first period starting from the time of the first urinary episode on the first of the 3 days. A valid diary day was defined as any of the three 24-hour periods with 2 or more any type of urinary incontinence episodes. Data collected from a 24-hour period with less than 2 urinary incontinence episodes (i.e., an invalid diary day) were set to missing. Baseline was defined as the latest pre-dose 3-day diary which has at least one valid diary day. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. Adjusted mean and standard error of adjusted mean has been reported.|Baseline (Pre-dose on Day 1) and Week 6 in Treatment Cycle 1|FAS1 Population|||Episodes||Standard Error|Mean
2549731|NCT02849184|Secondary|Change in NT-proBNP|Percentage change in NT-proBNP from baseline to 2 weeks|2 weeks||||percentage change||95% Confidence Interval|Median
2549732|NCT02849184|Secondary|Change in Nighttime SBP in Patients Achieved Low Sleep Satisfaction|"nighttime BPs are measured by ambulatory blood pressure monitoring. Sleep quality is measured by self-reported sleep diary (satisfaction level of sleep) at 2weeks.~Patients are divided by sleep satisfaction and compared nighttime SBP change (value at 2 weeks minus value at baseline)."|2 weeks|Patients who were not satisfied with sleep as of 2 weeks|||mmHg||Standard Error|Mean
2549733|NCT02849184|Secondary|Change in Urinary Albumin-to-creatinine Ratio (UACR)|Percentage change in UACR from baseline to 2 weeks|2 weeks||||percentage change||95% Confidence Interval|Median
2549734|NCT02849184|Secondary|Change in Nighttime SBP in Patients Achieved High Sleep Satisfaction|"nighttime BPs are measured by ambulatory blood pressure monitoring. Sleep quality is measured by self-reported sleep diary (satisfaction level of sleep) at 2 weeks.~Patients are divided by sleep satisfaction and compared nighttime SBP change (value at 2 weeks minus value at baseline)."|2 weeks|Patients who were satisfied with sleep as of 2 weeks|||mmHg||Standard Error|Mean
2549735|NCT02849184|Secondary|Changes in the Time to Sleep Onset|Time to sleep onset was assessed using a sleep diary. Value at week 2 - Value at week 0|2 weeks||||hours||Standard Error|Mean
2549736|NCT02849184|Secondary|Changes in the Total Sleep Time|Total sleep time was assessed using a sleep diary. Value at week 2 - Value at week 0|2 weeks||||hours||Standard Error|Mean
2549737|NCT02849184|Secondary|Change in Morning Systolic Blood Pressure Variability|To compare the efficacy of suvorexant versus placebo on morning SBP variability by ABPM Variability: SD Change: value at 2 weeks minus value at baseline|2 weeks||||mmHg||Standard Error|Mean
2549738|NCT02849184|Primary|Change in Sleep Systolic Blood Pressure|"To compare the efficacy of suvorexant versus placebo on sleep systolic blood pressure (SBP) by ambulatory blood pressure monitoring (ABPM).~Change: sleep SBP value at 2 weeks minus value at baseline"|2 weeks||||mmHg||Standard Error|Mean
2549739|NCT02849080|Secondary|Change in DTSQ- Sustainability|"Change from week 0 in diabetes treatment satisfaction questionnaire - status (DTSQs) was evaluated at week 104. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the data from the in-trial observation period."|Week 0, week 104|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2549740|NCT02849080|Secondary|Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Sustainability|Short form (SF)-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at week 104. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.|Week 0, week 104|Overall number of participants analyzed = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2549741|NCT02849080|Secondary|Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)- Sustainability|Number of participants with treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-109 ((104-week treatment period for participants who continued in the extension phase or 52-week treatment period for participants who did not continue in the extension phase) plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Week 0-109|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Participants|||Count of Participants
2549842|NCT02847858|Primary|Percentage of Participants Who Report Using a Non-barrier Method of Birth Control in the Prior 3 Months (Aim 3b)|Recorded via self-administered online survey|Baseline, 3 months, 6 months|All participants who reported what they used to prevent pregnancy in the prior 3 months at Baseline or at 3 months or at 6 months|||Participants|||Count of Participants
2549742|NCT02849080|Secondary|Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes)- Sustainability|Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-109 ((104-week treatment period for participants who continued in the extension phase or 52-week treatment period for participants who did not continue in the extension phase) plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Week 0-109|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Episodes|||Number
2549743|NCT02849080|Secondary|Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Sustainability|Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 104. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 104|Overall number of participants analyzed = number of participants with available data.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2549744|NCT02849080|Secondary|Change in Pulse Rate- Sustainability|Change from baseline (week 0) in pulse rate was evaluated at week 104. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 104|Overall number of participants analyzed = number of participants with available data.|||Beats per minute||Standard Deviation|Mean
2549745|NCT02849080|Secondary|Change in Lipase (Ratio to Baseline)- Sustainability|Change from baseline (week 0) in lipase (U/L) to week 104 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, Week 104|Overall number of participants analyzed = number of participants with available data.|||Ratio of lipase||Geometric Coefficient of Variation|Geometric Mean
2549746|NCT02849080|Secondary|Change in Amylase (Ratio to Baseline)- Sustainability|Change from baseline (week 0) in biochemical parameter- amylase (units per liter [U/L]) to week 104 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 104|Overall number of participants analyzed = number of participants with available data.|||Ratio of amylase||Geometric Coefficient of Variation|Geometric Mean
2549747|NCT02849080|Secondary|Number of TEAEs During Exposure to Trial Product- Sustainability|Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 109 ((104-week treatment period for participants who continued in the extension phase or 52-week treatment period for participants who did not continue in the extension phase) plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0-109|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Events|||Number
2549748|NCT02849080|Secondary|Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target or HbA1c Reduction ≥ 1%-Point (10.9 mmol/Mol) (Yes/no)- Sustainability|Participants who achieved HbA1c <7.0% ADA target or HbA1c reduction ≥ 1%-point (10.9 mmol/mol) (yes/no), was evaluated at week 104. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 104|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2549749|NCT02849080|Secondary|Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Sustainability|Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at week 104 is presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 104|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2549750|NCT02849080|Secondary|Participants Who Achieve Weight Loss ≥5% (Yes/no)- Sustainability|Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 104|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2549751|NCT02849080|Secondary|Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Sustainability|Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at week 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 104|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2550151|NCT02839876|Other Pre-specified|Overall Hospital Admission Costs|difference in total hospital admission cost between groups|0-72 hours||||US dollars||Inter-Quartile Range|Median
2549754|NCT02849080|Secondary|Change in BMI- Sustainability|Change from baseline (week 0) in body mass index (BMI) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, Week 104|Overall number of participants analyzed = number of participants with available data.|||kg/m^2||Standard Deviation|Mean
2549755|NCT02849080|Secondary|Change in FPG- Sustainability|Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 104|Overall number of participants analyzed = number of participants with available data.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2549756|NCT02849080|Secondary|Change in Body Weight (%)- Sustainability|Relative change from baseline (week 0) in body weight (kg) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 104|Overall number of participants analyzed = number of participants with available data.|||Percentage change||Standard Deviation|Mean
2549757|NCT02849080|Secondary|Change in Body Weight (kg)- Sustainability|Change from baseline (week 0) in body weight was evaluated at week 104. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 104|Overall number of participants analyzed = number of participants with available data.|||Kg||Standard Deviation|Mean
2549758|NCT02849080|Secondary|Change in HbA1c- Sustainability|Change from baseline (week 0) in HbA1c was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 104|Overall number of participants analyzed = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2549759|NCT02849080|Secondary|Change in DTSQ- Switch|"Change from week 52 in diabetes treatment satisfaction questionnaire - status (DTSQs) was evaluated at week 104. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the data from the in-trial observation period."|Week 52, week 104|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2549760|NCT02849080|Secondary|Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)- Switch|SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from week 52 in the domain scores and component summary (PCS and MCS) scores were evaluated at week 104. A positive change score indicates an improvement since week 52. Results are based on the data from the in-trial observation period.|Week 52, week 104|Overall number of participants analyzed = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2549761|NCT02849080|Secondary|Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)- Switch|Number of participants with treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 53 to 109. Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Week 53-109|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Participants|||Count of Participants
2549762|NCT02849080|Secondary|Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes- Switch|Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 53 to 109. Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Week 53-109|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Episodes|||Number
2550152|NCT02839876|Other Pre-specified|Hospital Length of Stay|Time to both discharge readiness and to actual discharge|0-72 hours|Only completed participants are included.|||days||Inter-Quartile Range|Median
2549763|NCT02849080|Secondary|Change in Blood Pressure (Systolic and Diastolic Blood Pressure)- Switch|Change from week 52 in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 104. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 52, week 104|Overall number of participants analyzed = number of participants with available data.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2549764|NCT02849080|Secondary|Change in Pulse Rate- Switch|Change from week 52 in pulse rate was evaluated at week 104. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 52, week 104|Overall number of participants analyzed = number of participants with available data.|||Beats per minute||Standard Deviation|Mean
2549765|NCT02849080|Secondary|Change in Lipase (Ratio to Baseline)- Switch|Change from week 52 in lipase (U/L) to week 104 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 52, Week 104|Overall number of participants analyzed = number of participants with available data.|||Ratio of lipase||Geometric Coefficient of Variation|Geometric Mean
2549766|NCT02849080|Secondary|Change in Amylase (Ratio to Baseline)- Switch|Change from week 52 in biochemical parameter- amylase (U/L) to week 104 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 52, Week 104|Overall number of participants analyzed = number of participants with available data.|||Ratio of amylase||Geometric Coefficient of Variation|Geometric Mean
2549767|NCT02849080|Secondary|Number of TEAEs During Exposure to Trial Product- Switch|Treatment emergent adverse events (TEAEs) were recorded from week 53 to week 109. Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 53-109|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.|||Events|||Number
2549768|NCT02849080|Secondary|Time to Rescue Medication- Switch|Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 53 to week 104. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after re-randomisation (week 52) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Weeks 53-104|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2549769|NCT02849080|Secondary|Time to Additional Anti-diabetic Medication- Switch|Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the period from week 53 to week 104. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after re-randomisation (week 52) and before (planned) end-of-treatment (week 104), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 53-104|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2549770|NCT02849080|Secondary|Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target and no Need for Rescue Medication (Yes/no)- Switch|Participants who achieved HbA1c <7.0% (American Diabetes Association (ADA) target) and no need for rescue medication (yes/no), was evaluated at week 104. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Week 104 (i.e., after 52 weeks of treatment in the extension phase)|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2549771|NCT02849080|Secondary|Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)- Switch|Participants who achieved HbA1c less than 7.0% without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at week 104 is presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 104 (i.e., after 52 weeks of treatment in the extension phase)|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2549772|NCT02849080|Secondary|Participants Who Achieve Weight Loss ≥5% (Yes/no)- Switch|Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 104 (i.e., after 52 weeks of treatment in the extension phase)|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2549773|NCT02849080|Secondary|Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)- Switch|Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at week 104 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 104 (i.e., after 52 weeks of treatment in the extension phase)|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2549774|NCT02849080|Secondary|Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)- Switch|Participants who achieved HbA1c <7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 104. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 104 (i.e., after 52 weeks of treatment in the extension phase)|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2549775|NCT02849080|Secondary|Change in Waist Circumference- Switch|Change from week 52 in waist circumference was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 52, week 104|Overall number of participants analyzed = number of participants with available data.|||Centimeters (cm)||Standard Deviation|Mean
2549776|NCT02849080|Secondary|Change in BMI- Switch|Change from week 52 in body mass index (BMI) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 52, Week 104|Overall number of participants analyzed = number of participants with available data.|||kg/m^2||Standard Deviation|Mean
2549777|NCT02849080|Secondary|Change in FPG- Switch|Change from week 52 in fasting plasma glucose (FPG) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 52, week 104|Overall number of participants analyzed = number of participants with available data.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2549778|NCT02849080|Secondary|Change in Body Weight (%)- Switch|Relative change from week 52 in body weight (kg) was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 52, week 104|Overall number of participants analyzed = number of participants with available data.|||Percentage change||Standard Deviation|Mean
2549779|NCT02849080|Secondary|Change in Body Weight- Switch|Change from week 52 in body weight was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 52, week 104|Overall number of participants analyzed = number of participants with available data.|||Kg||Standard Deviation|Mean
2549780|NCT02849080|Secondary|Change in HbA1c- Switch|Change from week 52 in HbA1c was evaluated at week 104. Results are based on the data from the in-trial observation period, which was the time period from when a participant was re-randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 52, week 104|Overall number of participants analyzed = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2549781|NCT02849080|Secondary|Change in Blood Pressure (Systolic and Diastolic Blood Pressure)|Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 52|Overall number of participants analyzed = number of participants with available data.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2549782|NCT02849080|Secondary|Change in Pulse Rate|Change from baseline (week 0) in pulse rate was evaluated at week 52. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 52|Overall number of participants analyzed = number of participants with available data.|||Beats per minute||Standard Deviation|Mean
2549783|NCT02849080|Secondary|Change in Lipase (Ratio to Baseline)|Change from baseline (week 0) in lipase (U/L) to week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, Week 52|Overall number of participants analyzed = number of participants with available data.|||Ratio of lipase||Geometric Coefficient of Variation|Geometric Mean
2549784|NCT02849080|Secondary|Change in Amylase (Ratio to Baseline)|Change from baseline (week 0) in biochemical parameter- amylase (units per liter [U/L]) to week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, Week 52|Overall number of participants analyzed = number of participants with available data.|||Ratio of amylase||Geometric Coefficient of Variation|Geometric Mean
2549793|NCT02849080|Secondary|Participants Who Achieve Weight Loss ≥5% (Yes/no)|Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 52|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2549785|NCT02849080|Secondary|Paticipants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)|Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period for participants who continued in the extension phase; 52-week treatment period plus the 5-week follow-up period for participants who did not continue in the extension phase). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Week 0-57|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Participants|||Count of Participants
2549786|NCT02849080|Secondary|Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes|Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-57 (52-week treatment period for participants who continued in the extension phase; 52-week treatment period plus the 5-week follow-up period for participants who did not continue in the extension phase). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Week 0-57|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Episodes|||Number
2549787|NCT02849080|Secondary|Number of TEAEs During Exposure to Trial Product|Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 57 (52-week treatment period for participants who continued in the extension phase; 52-week treatment period plus the 5-week follow-up period for participants who did not continue in the extension phase). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0-57|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.|||Events|||Number
2549788|NCT02849080|Secondary|Time to Additional Anti-diabetic Medication|Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the period from week 0 to week 52. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 52), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-52|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2549789|NCT02849080|Secondary|Time to Rescue Medication|Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 52. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Weeks 0-52|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2549790|NCT02849080|Secondary|Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)|Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at week 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 52|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2549791|NCT02849080|Secondary|Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)|Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at week 52 is presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 52|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2549792|NCT02849080|Secondary|Participants Who Achieve Weight Loss ≥10% (Yes/no)|Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at week 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 52|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2549794|NCT02849080|Secondary|Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)|Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at week 52 is presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 52|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2549795|NCT02849080|Secondary|Change in DTSQ|"Change from baseline (week 0) in diabetes treatment satisfaction questionnaire - status (DTSQs) was evaluated at week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the data from the in-trial observation period."|Week 0, Week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2549796|NCT02849080|Secondary|Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)|SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at week 52. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.|Week 0, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2549797|NCT02849080|Secondary|Change in Triglycerides (Ratio to Baseline)|Change from baseline (week 0) in triglycerides (mmol/L) at week 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 52|Overall number of participants analyzed = number of participants with available data.|||Ratio of triglycerides||Geometric Coefficient of Variation|Geometric Mean
2549798|NCT02849080|Secondary|Change in HDL Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 52|Overall number of participants analyzed = number of participants with available data.|||Ratio of HDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2549799|NCT02849080|Secondary|Change in LDL Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at week 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 52|Overall number of participants analyzed = number of participants with available data.|||Ratio of LDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2549800|NCT02849080|Secondary|Change in Total Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in total cholesterol (mmol/L) at week 52 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, Week 52|Overall number of participants analyzed = number of participants with available data.|||Ratio of total cholesterol||Geometric Coefficient of Variation|Geometric Mean
2549801|NCT02849080|Secondary|Change in Waist Circumference|Change from baseline (week 0) in waist circumference was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 52|Overall number of participants analyzed = number of participants with available data.|||Centimeters (cm)||Standard Deviation|Mean
2549802|NCT02849080|Secondary|Change in BMI|Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, Week 52|Overall number of participants analyzed = number of participants with available data.|||Kilograms per square meter (kg/m^2)||Standard Deviation|Mean
2549803|NCT02849080|Secondary|Change in Body Weight (%)|Relative change from baseline (week 0) in body weight (kg) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 52|Overall number of participants analyzed = number of participants with available data.|||Percentage change||Standard Deviation|Mean
2569320|NCT02544451|Secondary|Observational Cohort: Safety as Assessed by Serious Adverse Events (SAEs)||Day 1 up to Week 100|All participants included in the observational cohort.|||participants|||Number
2549804|NCT02849080|Secondary|Change in FPG|Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 52|Overall number of participants analyzed = number of participants with available data.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2549805|NCT02849080|Secondary|Change in HbA1c|Change from baseline (week 0) in HbA1c was evaluated at week 52. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 52|Overall number of participants analyzed = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2549806|NCT02849080|Secondary|Change in Body Weight|Change from baseline (week 0) in body weight was evaluated at week 52. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Week 0, week 52|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Kilogram (Kg)||Standard Deviation|Mean
2549807|NCT02849080|Primary|Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)|Participants who achieved HbA1c <7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 52. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Week 52|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2549808|NCT02848729|Primary|Time to Maximum Concentration (Tmax) of Acetaminophen|Following the administration of drugs, the time at which the plasma concentration reaches Cmax is called Tmax. Tmax is reported for the 6-hour dosing periods before (hours -6 to 0), during (hours 0-6 and 6-12) and after (hours 12-18) morphine co-administration for each route of acetaminophen administration.|hours -6 to 0, 0-6, 6-12 and 12-18 during treatment with each mode of acetaminophen administration|Per-protocol population|||hours||Full Range|Mean
2549809|NCT02848729|Primary|Maximum Concentration (Cmax) of Acetaminophen|Following the administration of drugs, the plasma concentration generally reaches a single, well-defined peak which is the most drug that is available for the body to use (Cmax). Cmax is reported for the 6-hour dosing periods before (hours -6 to 0), during (hours 0-6 and 6-12), and after (hours 12-18) morphine co-administration for each route of acetaminophen administration.|hours -6 to 0, 0-6, 6-12, and 12-18 during treatment with each mode of acetaminophen administration|Per-protocol population|||mcg/mL||Standard Deviation|Mean
2549810|NCT02848729|Primary|Area Under the Plasma Concentration-time Curve Over 18 Hours (AUC18) for Acetaminophen After First Morphine Co-administration|AUC18 is reported for the 18-hour treatment period after first morphine co-administration, for each route of acetaminophen administration|hours 0-18 during treatment with each mode of acetaminophen administration|Per-protocol population, which is defined as the participants who received all study medication, provided all 33 blood samples within required time points and completed the study with no major protocol deviations.|||hour*microgram per milliliter (h*mcg/mL)||Standard Deviation|Mean
2549811|NCT02848729|Primary|Area Under the Plasma Concentration-time Curve Over 6 Hours (AUC6) for Acetaminophen|The area under the plasma drug concentration-time curve (AUC) is an estimate of how much drug remains available for the body to use, within a certain amount of time after the drug is administered. AUC6 is reported for each of the 6-hour dosing periods of acetaminophen before (hours -6 to 0), during (hours 0-6 and 6-12) and after (hours 12-18) morphine co-administration for each route of acetaminophen administration|hours -6 to 0, 0-6, 6-12, and 12-18 during treatment with each mode of acetaminophen administration|Per-protocol population, which is defined as the participants who received all study medication, provided all 33 blood samples within required time points and completed the study with no major protocol deviations.|||hour*microgram per milliliter (h*mcg/mL)||Standard Deviation|Mean
2549812|NCT02848664|Secondary|Cortical Activation for Swallowing|The level of cortical activation for swallowing was measured using near infra-red spectroscopy. Overall blood oxygenation level during swallowing was compared with the level during a non activation period prior to swallowing. To compute Z scores, the change in overall level between swallowing and prior to swallowing was divided by the standard deviation of the level prior to swallowing. The Z scores measured prior to and post device use for 3 months were compared.|From before onset of device use to return 3 months later|Same patients before and after device use|||Z score||Standard Error|Mean
2549813|NCT02848664|Secondary|Laryngeal Elevation Relative to Hyoid Elevation for Vestibule Closure|Calibrated kinematic measures from videofluoroscopic imaging during a modified barium swallow study. Computed the change in peak elevation in millimeters during swallowing from the rest position before swallowing for two structures: the larynx and the hyoid bone. The peak elevation of the two structures were compared by subtracting the hyoid peak elevation from the laryngeal peak elevation. If the measure was positive the larynx was elevated to a greater degree than the hyoid bone resulting in vestibule closure and airway protection during the swallow.|From before onset of device use to return 3 months later|Only 5 patients were able to undergo a repeated modified barium swallow study after device use.|||millimeters||Standard Deviation|Mean
2549814|NCT02848664|Primary|Dysphagia Handicap Index (DHI)|Total handicap Score from 0 (no Handicap) to 100 (Severe Handicap)|From before onset of device use to return 3 months later||||units on a scale||Standard Deviation|Mean
2549815|NCT02848664|Primary|Change in Dysphagia Outcome and Severity Scale (DOSS) Rating|"An ordinal scale of 7 levels of severity of swallowing disorder with 1 being the lowest level and 7 being the highest level.~Level 1 is Severe dysphagia Nothing per oral and unable to tolerate any per oral liquid/substance safely.~Level 2 is Moderately severe dysphagia, requires maximum assistance or use of strategies with partial per oral only, tolerates at least one consistency safely with total use of strategies.~Level 3 is Moderate Dysphagia, requires total assist, supervision, or strategies with two or more consistencies restricted.~Level 4 is Mild-moderate Dysphagia, Requires intermittent supervision/cueing, one or two consistencies restricted level 5 is Mild dysphagia: requires distant supervision may need one diet consistency restricted Level 6 Within functional limits, modified independence Level 7 Normal in all situations"|From before onset of device use to return 3 months later|Patients with Severe/Moderate to Severe dysphagia, chronic for more than 6 months, nutrition is by enteric means, may be able to ingest one consistencies with supervision|||Participants|||Count of Participants
2549816|NCT02848651|Secondary|Percentage of Participants With Objective Response (Per RECIST v1.1) by Various bTMB Quantiles|Objective response rate was defined as the proportion of participants who had a confirmed best overall response of either PR or CR per RECIST v1.1.|Baseline up to 32 months|Biomarker analysis population included all participants who received at least one dose of study drug and whose tumor samples had a maximum somatic allele frequency (MSAF) >=1%.|||Percentage of Participants||95% Confidence Interval|Number
2549817|NCT02848651|Secondary|OS by Various bTMB Cutoff Points 16 and 20|OS was defined as the time from the first dose of study drug to the time of death from any cause during the study.|From baseline until death (up to 32 months)|Biomarker analysis population included all participants who received at least one dose of study drug and whose tumor samples had a maximum somatic allele frequency (MSAF) >= 1%.|||Months||95% Confidence Interval|Median
2549818|NCT02848651|Secondary|Percentage of Participants Who Are Alive and Progression-Free (Per RECIST v1.1) at 6, 9, 12, and 18 Months by Various bTMB Quantiles|A summary of the number of patients at risk and survival rate for the time points of 6, 9, 12, and 18 months.|Months 6, 9, 12, and 18|Biomarker analysis population included all participants who received at least one dose of study drug and whose tumor samples had a maximum somatic allele frequency (MSAF) >=1%.|||Percentage of Participants||95% Confidence Interval|Number
2549819|NCT02848651|Secondary|Percentage of Participants With Adverse Events|Adverse events were defined as any untoward medical occurrence in a subject administered atezolizumab, regardless of causal attribution.|Baseline up to 32 months|Safety analyses population included all participants who received at least one dose of study drug.|||Percentage of Participants|||Number
2549820|NCT02848651|Secondary|Overall Survival (OS)|OS was defined as the time from the first dose of study drug to the time of death from any cause during the study.|From baseline until death (up to 32 months)|Efficacy Evaluable Population included all participants who received at least one dose of atezolizumab.|||Months||95% Confidence Interval|Median
2549821|NCT02848651|Secondary|Disease Control Rate (DCR) Per RECIST v1.1 as Determined by Investigator|Confirmed disease control rate (cDCR) was defined as the rate of patients with CR or PR as the best response, or SD maintained for 24 weeks, per RECIST v1.1.|Baseline up to 32 months|Efficacy Evaluable Population included all participants who received at least one dose of atezolizumab.|||Percentage||95% Confidence Interval|Number
2549822|NCT02848651|Secondary|Duration of Response (DOR) Per RECIST v1.1 as Determined by Investigator|Investigator-assessed DOR by RECIST v1.1 was defined as the time from initial occurrence of documented CR or PR until documented disease progression as determined by the investigator, or death, whichever occurred first.|Baseline up to 32 months|Duration of response included a subset of participants who achieved an objective response in the efficacy evaluable population.|||Months||95% Confidence Interval|Number
2549823|NCT02848651|Secondary|Progression-Free Survival (PFS) Per RECIST v1.1 as Determined by Investigator|Investigator-assessed PFS by RECIST v1.1 was defined as the time from the first dose of study drug to the time of PD or death from any cause during the study, whichever occurred first.|Baseline up to 32 months|Efficacy Evaluable Population included all participants who received at least one dose of atezolizumab.|||Months||95% Confidence Interval|Median
2549824|NCT02848651|Primary|Progression-Free Survival (PFS) Per RECIST v1.1 as Determined by Investigator, by Positive Versus Negative bTMB Groups|Investigator-assessed PFS by RECIST v1.1 was defined as the time from the first dose of study drug to the time of PD or death from any cause during the study, whichever occurred first.|Baseline up to 32 months|Biomarker analysis population included all participants who received at least one dose of study drug and whose tumor samples had a maximum somatic allele frequency (MSAF) >= 1%.|||Months||95% Confidence Interval|Median
2549825|NCT02848651|Primary|Percentage of Participants With Objective Response Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Determined by Investigator|Investigator-assessed objective response rate was defined as the proportion of participants who had a confirmed best overall response of either PR or CR per RECIST v1.1.|Baseline up to 32 months|Efficacy and Safety analysis Population included participants who received at least one dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
2549826|NCT02848326|Secondary|Change From Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period|Participants recorded allowed medication(s) to treat an acute migraine in the daily diary. The 4-week (monthly) acute medication use days was defined as the total number of reported acute medication use days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. A negative change from Baseline indicates improvement.|Baseline (First 28 Days of Screening/Baseline Period) to Week 12|MITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data.|||acute medication use days per month||Standard Error|Least Squares Mean
2549839|NCT02847858|Secondary|Percentage of Participants Who Receive or Make an Appointment to Receive or Receive a Prescription for a Non-barrier Method (Aim 3a)|Recorded via self-administered online survey|Post-visit Follow-up|All participants who answered the appropriate items at Post-visit Follow-up|||Participants|||Count of Participants
2552286|NCT02796963|Secondary|Number of Men Reporting Using Tencent QQ (QQ) in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing||From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
2549827|NCT02848326|Secondary|Percentage of Participants With at Least a 50% Reduction in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period|Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration and acute symptomatic medication use. The 4-week migraine days=total number of reported migraine days in diary divided by total number of days with diary records in each 4-week period multiplied by 28. Each 4-week period was averaged.|Baseline (First 28 Days of Screening/Baseline Period) to Week 12|MITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data.|||percentage of participants|||Number
2549828|NCT02848326|Secondary|Change From Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period|Participants recorded daily total duration of a headache in a diary. A headache day is any calendar day on which the participant experienced a headache qualified by duration and acute symptomatic medication use. The 4-week (monthly) headache days was defined as the total number of reported headache days in the diary divided by the total number of days with diary records during each 4-week period and multiplied by 28. Each 4-week period was averaged. Negative change from Baseline indicates improvement.|Baseline (First 28 Days of Screening/Baseline Period) to Week 12|MITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data.|||headache days per month||Standard Error|Least Squares Mean
2549829|NCT02848326|Primary|Change From Baseline in Mean Monthly Migraine Days (Migraine/Probable Migraine Headache Days) Across the 12-Week Treatment Period|Participants recorded daily duration of migraine in a diary. A migraine day was any calendar day on which the participant experienced a migraine headache qualified by duration and acute symptomatic medication use. The 4-week migraine days was defined as the total number of reported migraine days in diary divided by total number of days with diary records during each 4- week period and multiplied by 28. Each 4-week period was averaged. Negative change from Baseline indicates improvement.|Baseline (First 28 Days of Screening/Baseline Period) to Week 12|MITT Population included all randomized participants who received at least 1 dose of study treatment, had an evaluable baseline period of diary data, and had at least 1 evaluable post-baseline 4-week (Weeks 1-4, 5-8, and 9-12) of diary data.|||migraine days per month||Standard Error|Least Squares Mean
2549830|NCT02848222|Primary|Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day)||Baseline through 1 month|In Gr1, 25 subjects were randomized, 18 subjects completed, 7 discontinued early and 1 subject's data was not used due to poor compliance resulting in 17 subjects analyzed. In Gr2, 18 subjects were randomized and 17 completed. In Gr3, 17 subjects were randomized and completed.|||hours per day||Standard Deviation|Mean
2549831|NCT02847858|Secondary|Adolescent Assessment of Health-E You App Benefits: Improved the Quality of my Visit With my Health Care Provider (Aim 2a8)|Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree|Immediate Follow-up|Intervention group adolescents|||Participants|||Count of Participants
2549832|NCT02847858|Secondary|Adolescent Assessment of Health-E You App Benefits: Helped me Talk With my Health Care Provider About Birth Control (Aim 2a7)|Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree|Immediate Follow-up|Intervention group adolescents|||Participants|||Count of Participants
2549833|NCT02847858|Secondary|Adolescent Assessment of Health-E You App Benefits: Gave me Useful Information About Birth Control (Aim 2a6)|Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree|Immediate Follow-up|Intervention group adolescents|||Participants|||Count of Participants
2549834|NCT02847858|Secondary|Adolescent Assessment of Health-E You App Benefits: Helped me Choose a Birth Control Method (Aim 2a5)|Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree|Immediate Follow-up|Intervention group adolescents|||Participants|||Count of Participants
2549835|NCT02847858|Secondary|Post-study Assessment of Provider Ratings of Whether the Health-E You APP Makes Clinic Schedule Run Behind (Aim 2a4)|Provider ratings of whether the App makes clinic schedules run behind, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees.|Post-study completion|Clinical providers in Health-E You Intervention Clinics|||Participants|||Count of Participants
2549836|NCT02847858|Secondary|Post-study Assessment of Provider Ratings of Whether the Health-E You APP Improves the Effectiveness of the Clinical Encounter by Integrating Reproductive Health Into All Visits (Aim 2a3)|Provider ratings of whether the App improves effectiveness of the clinical encounter by integrating reproductive health into all visits, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees.|Post-study completion|Clinical providers in Health-E You Intervention Clinics|||Participants|||Count of Participants
2549837|NCT02847858|Secondary|Post-study Assessment of Provider Ratings of Whether the Health-E You APP Helps Clinicians Provide Individually Tailored Discussion of Contraception Options (Aim 2a2)|Provider ratings of whether the App helps clinicians provide more individually tailored discussion of contraception options, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees.|Post-study completion|Clinical providers in Health-E You Intervention Clinics|||Participants|||Count of Participants
2549838|NCT02847858|Secondary|Post-study Assessment of Providers' Rating of How the Health-E You APP Improves the Effectiveness of the Clinical Encounter for Patients: App Helps Patients Engage in Contraception Decision Making (Aim 2a1)|Provider ratings of whether the App improves the effectiveness of the clinical encounter for patients, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees.|Post-study completion|Providers seeing patients for care in Health-E You Intervention Clinics|||Participants|||Count of Participants
2552287|NCT02796963|Secondary|Number of Men Reporting Using Wechat in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing||From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
2549843|NCT02847858|Primary|Contraception Use Self-efficacy Scale Score (Aim 1c)|The 3-item attitude scale assessing perceived ability to choose and use contraception was self-administered in an online survey; each item scored on a 0=not at all confident to 10=completely confident scale ; scale score is the sum of the 3 items scores (range 0-30); higher score=greater self-efficacy|Baseline, 3 months, 6 months|All participants for whom a self-efficacy score was recorded at Baseline or at 3 months or at 6 months|||Score on a scale||Standard Deviation|Mean
2549844|NCT02847858|Primary|Contraception Use Self-efficacy Scale Score (Aim 1b)|The 3-item attitude scale assessing perceived ability to choose and use contraception was self-administered in an online survey; each item scored on a 0=not at all confident to 10=completely confident scale; scale score is the sum of the 3 items scores, range 0 - 30 (higher score=greater self-efficacy)|Pre-visit Baseline, Post-visit Follow-up (48 hours after Baseline)|All participants for whom a self-efficacy score was recorded either at Baseline or at Post-visit Follow-up|||Scores on a scale||Standard Deviation|Mean
2549845|NCT02847650|Secondary|Total Physician Withdrawal Checklist (PWC‑20) Score|The PWC-20 is a 20-item reliable and sensitive instrument for the assessment of benzodiazepine-like discontinuation symptoms. The total PWC-20 score is the sum of 20 item scores and ranges between 0 and 60. The higher score indicates more frequent/severe symptoms.|Day 119|All participants who received at least 1 dose of study treatment (PF-06649751 or placebo) and had PWC-20 evaluation.|||units on a scale||Full Range|Median
2549846|NCT02847650|Secondary|Change From Baseline in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS) Total Score at Days 35, 63, and 105|The QUIP-RS has 4 primary questions pertaining to commonly reported thoughts, urges/desires, and behaviors associated with impulsive-compulsive disorder , each applied to the 4 impulsive-compulsive disorders (compulsive gambling, buying, eating, and sexual behavior) and 3 related disorders (medication use, punding, and hobbyism). Each question is anchored with the following 5 responses: Never (0), Rarely (1), Sometimes (2), Often (3), and Very Often (4). The scoring range for each item (ie, disorder) is 0-16. The QUIP-RS total score range is 0-64. Higher score indicates a greater level of the impulsive compulsive disorder.|Baseline (Day -1 or randomization); Days 35, 63, 105|"All participants who received at least 1 dose of study treatment (PF-06649751 or placebo). Number Analyzed = Participants evaluable for this outcome measure at specified time points."|||units on a scale||Standard Deviation|Mean
2549847|NCT02847650|Secondary|Number of Participants With Worsening and New Onset Suicidality as Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)|The C-SSRS is an interview based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS responses were mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA). Participants with new onset suicidality were those without suicidal ideation and behavior at baseline and reported any suicidal behavior or ideation post-baseline as assessed by C-CASA code mapped from C-SSRS data. Participants with worsening suicidality were those who moved to a lower numbered C-CASA category than was reported at baseline.|Baseline (Day -1/randomization) up to Day 119 follow-up visit|All participants who received at least 1 dose of study treatment (PF-06649751 or placebo).|||Participants|||Count of Participants
2549848|NCT02847650|Secondary|Number of Participants Meeting the Categorical Summarization Criteria for Electrocardiogram (ECG) Parameters|ECG categorical summarization criteria: 1) QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): >=140 milliseconds (msec), >=50% increase from baseline; 2) PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): >=300 msec, >=25% increase when baseline is > 200 msec or >=50% increase when baseline is less than or equal to (<=) 200 msec; 3) QT interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole): absolute value of >=500 msec; 4) QTcF interval (QT corrected for heart rate using Fridericia's formula): absolute value of 450 to <480 msec, 480 to <500 msec, >=500 msec; an increase from baseline of 30 to <60 msec or >=60 msec.|Baseline (Day -1/randomization) up to Day 119 follow-up visit|"All participants who received at least 1 dose of study treatment (PF-06649751 or placebo). Number Analyzed represents the number of participants evaluable for each specified category."|||Participants|||Count of Participants
2549849|NCT02847650|Secondary|Number of Participants With Vital Signs Data Meeting Categorical Summarization and Orthostatic Hypotension Criteria|Vital signs categorical summarization criteria: 1) supine and standing systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); 2) supine and standing diastolic blood pressure (DBP) <50 mmHg; 3) supine pulse rate <40 or >120 beats per minute (bpm); 4) standing pulse rate <40 or >140 bpm; 5) maximum change from baseline (increase or decrease) in supine and standing DBP greater than or equal to (>=) 20 mmHg; 6) maximum change from baseline (increase or decrease) in supine and standing SBP >=30 mmHg. Orthostatic hypotension criterion was defined as a decrease of >=20 mmHg for SBP or >=10 mmHg for DBP 2 minutes after standing from a supine position.|Baseline (Day -1/randomization) up to Day 119 follow-up visit|All participants who received at least 1 dose of study treatment (PF-06649751 or placebo).|||Participants|||Count of Participants
2549850|NCT02847650|Secondary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)|Following safety laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute total neutrophils, absolute eosinophils, absolute basophils, absolute monocytes, and absolute lymphocytes); chemistry (blood urea nitrogen/urea and creatinine, glucose , calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, total protein); urinalysis (pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, urine bilirubin, urobilinogen, urine creatinine, microscopy, and specific gravity).|Baseline (Day -1/randomization) up to Day 119 follow-up visit|All participants who received at least 1 dose of study treatment (PF-06649751 or placebo) and had at least 1 observation of the given laboratory test.|||Participants|||Count of Participants
2549891|NCT02847260|Primary|Number of Participants With Successful Completion of the 16 Week Treatment Period.|Successful completion was defined as completion of the 16 week treatment period of the study without experiencing any serious adverse events considered by the investigator to be possibly related to Remodulin.|Baseline to week 16||||participants|||Number
2549851|NCT02847650|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment.|From first dose of study treatment up to 28 days after last dose (up to Day 133)|All participants who received at least 1 dose of study treatment (PF-06649751 or placebo).|||Participants|||Count of Participants
2549852|NCT02847650|Primary|Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total Score at Week 15|MDS-UPDRS Part III was used to assess the motor signs of Parkinson's disease. It was comprised of 33 sub-scores based on 18 items, several with right, left or other body distribution scores. Each question was anchored with 5 responses that were linked to commonly accepted clinical terms: 0=normal, 1=slight, 2=mild, 3=moderate, and 4=severe. The MDS-UPDRS Part III total score range is 0-132. Higher score indicates more severe motor signs of Parkinson's disease. A negative change from baseline represents an improvement in motor function.|Baseline (Day -1/randomization), Week 15|All participants who received at least 1 dose of study treatment (PF-06649751 or placebo) and had a baseline and Week 15 MDS-UPDRS score Part III.|||units on a scale||Standard Error|Least Squares Mean
2549853|NCT02847637|Secondary|Trough Plasma Concentration (Ctrough) of Emicizumab|Plasma concentrations of emicizumab were analyzed using a validated Enzyme Linked Immunosorbent Assay (ELISA). The lower limit of quantitation was 0.1 micrograms per milliliter (μg/mL). At the clinical cut-off date for primary analysis (15 Sep 2017), data was collected over a period of approximately 1 year.|Predose (Hour 0) on every week during Weeks 1-4, every 2 weeks during Weeks 5-8, every 4 weeks during Weeks 9-24, every 8 weeks during Weeks 25-48, every 12 weeks thereafter up to the end of the study (up to 2 years)|The All Emicizumab Population includes participants in Arms A, B, Cemi, and D treated with emicizumab; 2 participants who had not switched to emicizumab prophylaxis at time of analysis were excluded from Arm Cemi. Number analyzed represents participants per study arm with available samples at each specified timepoint.|||micrograms per milliliter (μg/mL)||Standard Deviation|Mean
2549854|NCT02847637|Secondary|Percentage of Participants With De Novo Development of Factor VIII (FVIII) Inhibitors|Levels of anti-FVIII antibodies (inhibitors) were analyzed using a validated FVIII activity assay. A participant was considered to have developed de novo FVIII inhibitors if the inhibitor levels detected in a post-baseline sample reached or exceeded a pre-determined threshold. At the clinical cut-off date for primary analysis (15 Sep 2017), data was collected over a period of approximately 1 year.|From Baseline up to 24 weeks after last dose of study drug (up to 2.5 years)|The All Emicizumab Population includes participants in Arms A, B, Cemi, and D treated with emicizumab; 2 were excluded from Arm Cemi (1 lost to follow-up before Week 24; 1 had not switched to emicizumab prophylaxis at time of analysis).|||percentage of participants|||Number
2549855|NCT02847637|Secondary|Percentage of Participants With Anti-Emicizumab Antibodies|A validated ELISA method was used to analyze the levels of anti-emicizumab antibodies in plasma. A sample was considered positive for anti-emicizumab antibodies if the test result reached or exceeded a pre-determined threshold. At the clinical cut-off date for primary analysis (15 Sep 2017), data was collected over a period of approximately 1 year.|From Baseline up to 24 weeks after last dose of study drug (up to 2.5 years)|The All Emicizumab Population includes 150 participants in Arms A, B, Cemi, and D treated with emicizumab; 2 were excluded from Arm Cemi (1 lost to follow-up before Week 24; 1 had not switched to emicizumab prophylaxis at time of analysis).|||percentage of participants|||Number
2549856|NCT02847637|Secondary|Percentage of Participants With Systemic Hypersensitivity, Anaphylaxis, or Anaphylactoid Reactions|At the clinical cut-off date for primary analysis (15 Sep 2017), data was collected over a period of approximately 1 year.|From Baseline up to 24 weeks after last dose of study drug (up to 2.5 years)|All participants in Arms A, B, and D who received at least one dose of emicizumab and all participants in Arm C who started the no prophylaxis study period. Participants in Arm Cemi are those from Arm C who switched after 24 weeks no prophylaxis to receive emicizumab prophylaxis (2 were excluded who did not switch at the time of analysis).|||percentage of participants|||Number
2549857|NCT02847637|Secondary|Percentage of Participants With Thrombotic Microangiopathy|At the clinical cut-off date for primary analysis (15 Sep 2017), data was collected over a period of approximately 1 year.|From Baseline up to 24 weeks after last dose of study drug (up to 2.5 years)|All participants in Arms A, B, and D who received at least one dose of emicizumab and all participants in Arm C who started the no prophylaxis study period. Participants in Arm Cemi are those from Arm C who switched after 24 weeks no prophylaxis to receive emicizumab prophylaxis (2 were excluded who did not switch at the time of analysis).|||percentage of participants|||Number
2549858|NCT02847637|Secondary|Percentage of Participants With Thromboembolic Events|At the clinical cut-off date for primary analysis (15 Sep 2017), data was collected over a period of approximately 1 year.|From Baseline up to 24 weeks after last dose of study drug (up to 2.5 years)|All participants in Arms A, B, and D who received at least one dose of emicizumab and all participants in Arm C who started the no prophylaxis study period. Participants in Arm Cemi are those from Arm C who switched after 24 weeks no prophylaxis to receive emicizumab prophylaxis (2 were excluded who did not switch at the time of analysis).|||percentage of participants|||Number
2549859|NCT02847637|Secondary|Percentage of Participants With Local Injection-Site Reactions|"Local adverse events that occurred within 24 hours after study drug administration and, in the investigator's opinion, were judged to be related to study drug injection, were captured as an injection-site reaction on the Adverse Event electronic Case Report Form (eCRF). An injection-related reaction that was localized was marked as a local injection-site reaction. At the clinical cut-off date for primary analysis (15 Sep 2017), data was collected over a period of approximately 1 year."|From Baseline up to 24 weeks after last dose of study drug (up to 2.5 years)|All participants in Arms A, B, and D who received at least one dose of emicizumab and all participants in Arm C who started the no prophylaxis study period. Participants in Arm Cemi are those from Arm C who switched after 24 weeks no prophylaxis to receive emicizumab prophylaxis (2 were excluded who did not switch at the time of analysis).|||percentage of participants|||Number
2549860|NCT02847637|Secondary|Percentage of Participants With Adverse Events of Abnormal Laboratory Values|The percentage of participants with adverse events of abnormal laboratory values is reported here. An abnormal laboratory value is defined as a laboratory test result outside of the normal range for hematology or serum chemistries. It is reported as an adverse event if it meets any of the following criteria: is accompanied by clinical symptoms; results in a change in study treatment (e.g., dosage modification, treatment interruption or discontinuation); results in a medical intervention or a change in concomitant therapy; or is clinically significant in the investigator's judgment. At the clinical cut-off date for primary analysis (15 Sep 2017), data was collected over a period of approximately 1 year.|From Baseline up to 24 weeks after last dose of study drug (up to 2.5 years)|All participants in Arms A, B, and D who received at least one dose of emicizumab and all participants in Arm C who started the no prophylaxis study period. Participants in Arm Cemi are those from Arm C who switched after 24 weeks no prophylaxis to receive emicizumab prophylaxis (2 were excluded who did not switch at the time of analysis).|||percentage of participants|||Number
2549861|NCT02847637|Secondary|Percentage of Participants With Adverse Events of Changes From Baseline in Physical Examination Findings|Post-baseline physical examination abnormalities that were not present at baseline or worsened were reported as adverse events. At the clinical cut-off date for primary analysis (15 Sep 2017), data was collected over a period of approximately 1 year.|From Baseline up to 24 weeks after last dose of study drug (up to 2.5 years)|All participants in Arms A, B, and D who received at least one dose of emicizumab and all participants in Arm C who started the no prophylaxis study period. Participants in Arm Cemi are those from Arm C who switched after 24 weeks no prophylaxis to receive emicizumab prophylaxis (2 were excluded who did not switch at the time of analysis).|||percentage of participants|||Number
2549862|NCT02847637|Secondary|Percentage of Participants With Adverse Events of Changes From Baseline in Vital Signs|The percentage of participants with adverse events of changes from baseline in vital signs is reported here. Vital signs measurements consisted of heart and respiratory rate, temperature, and systolic and diastolic blood pressures, with an abnormal vital sign value being outside of the normal range. An abnormal vital sign result is reported as an adverse event if it meets any of the following criteria: is accompanied by clinical symptoms; results in a change in study treatment (e.g., dosage modification, treatment interruption or discontinuation); results in a medical intervention or a change in concomitant therapy; or is clinically significant in the investigator's judgment. At the clinical cut-off date for primary analysis (15 Sep 2017), data was collected over a period of approximately 1 year.|From Baseline up to 24 weeks after last dose of study drug (up to 2.5 years)|All participants in Arms A, B, and D who received at least one dose of emicizumab and all participants in Arm C who started the no prophylaxis study period. Participants in Arm Cemi are those from Arm C who switched after 24 weeks no prophylaxis to receive emicizumab prophylaxis (2 were excluded who did not switch at the time of analysis).|||percentage of participants|||Number
2549863|NCT02847637|Secondary|Percentage of Participants With Adverse Events Leading to Withdrawal From Treatment|At the clinical cut-off date for primary analysis (15 Sep 2017), data was collected over a period of approximately 1 year.|From Baseline up to 24 weeks after last dose of study drug (up to 2.5 years)|All participants in Arms A, B, and D who received at least one dose of emicizumab and all participants in Arm C who started the no prophylaxis study period. Participants in Arm Cemi are those from Arm C who switched after 24 weeks no prophylaxis to receive emicizumab prophylaxis (2 were excluded who did not switch at the time of analysis).|||percentage of participants|||Number
2549864|NCT02847637|Secondary|Percentage of Participants With Grade ≥3 Adverse Events|The World Health Organization (WHO) toxicity grading scale will be used for assessing adverse event severity. For adverse events that are not specifically listed in the WHO toxicity grading scale, a grade 3 adverse event is defined as: severe, marked limitation in activity, some assistance usually required, medical intervention or therapy required, hospitalization possible; and a grade 4 adverse event is defined as: life-threatening, extreme limitation in activity, significant assistance required, significant medical intervention or therapy required, hospitalization or hospice care probable. At the clinical cut-off date for primary analysis (15 Sep 2017), data was collected over a period of approximately 1 year.|From Baseline up to 24 weeks after last dose of study drug (up to 2.5 years)|All participants in Arms A, B, and D who received at least one dose of emicizumab and all participants in Arm C who started the no prophylaxis study period. Participants in Arm Cemi are those from Arm C who switched after 24 weeks no prophylaxis to receive emicizumab prophylaxis (2 were excluded who did not switch at the time of analysis).|||percentage of participants|||Number
2549865|NCT02847637|Secondary|Percentage of Participants With at Least One Adverse Event|The percentage of participants experiencing at least one adverse event, including all non-serious and serious adverse events, is reported here. At the clinical cut-off date for primary analysis (15 Sep 2017), data was collected over a period of approximately 1 year.|From Baseline up to 24 weeks after last dose of study drug (up to 2.5 years)|All participants in Arms A, B, and D who received at least one dose of emicizumab and all participants in Arm C who started the no prophylaxis study period. Participants in Arm Cemi are those from Arm C who switched after 24 weeks no prophylaxis to receive emicizumab prophylaxis (2 were excluded who did not switch at the time of analysis).|||percentage of participants|||Number
2549866|NCT02847637|Secondary|Hemophilia-Specific Quality of Life - Short Form (Haemo-QoL-SF) Questionnaire Score in Adolescent Participants (12 to 17 Years of Age) in the Randomized Population at Week 25|The Haemo-QoL-SF contains 35 items, which cover nine domains considered relevant for the children's health-related quality of life (physical health, feelings, view of yourself, family, friends, other people, sports and school, dealing with hemophilia and treatment). Items are rated with five respective response options: never, seldom, sometimes, often, and always. Haemo-QoL-SF total score range from 0 to 100, where lower scores reflect better health-related quality of life.|Week 25|The pre-specified efficacy objective was the comparison of Haemo-QoL-SF scores at Week 25 in adolescents who were previously on episodic treatment (i.e., randomized to Arms A, B, or C). Because there was a total of just one adolescent randomized to this study (in Arm C), statistical analyses could not be performed and no data is reported.||||||
2549892|NCT02847182|Secondary|Severity of Unexpected Adverse Events, by Relation to Study Product|Grade/severity will be assessed according to CTCAE v4.0 guidelines|12 months|||||||
2549893|NCT02847182|Secondary|Incidence of Unexpected Adverse Events, by Relation to Study Product||12 months|||||||
2549894|NCT02847182|Secondary|Severity of Graft vs. Host Disease|Grade/severity will be assessed according to CTCAE v4.0 guidelines|12 months|||||||
2549867|NCT02847637|Secondary|EQ-5D-5L Questionnaire Index Utility Score in the Randomized Population at Week 25|EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L VAS. The EQ-5D-5L health state profile is designed to record the participant's current health state in 5 domains: mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Responses from the five domains are used to calculate a single index utility score on a scale of 0 to 1, with higher scores reflective of better quality of life. The means were derived via an analysis of covariance (ANCOVA) model and have been adjusted for the following co-variates: baseline score, treatment group, and treatment by baseline interaction term.|Baseline, Week 25|Participants randomized to Arms A, B, and C. The number analyzed represents participants who provided responses at Baseline and Week 25.|||units on a scale||Standard Deviation|Mean
2549868|NCT02847637|Secondary|European Quality of Life 5-Dimensions-5 Levels (EQ-5D-5L) Questionnaire Visual Analogue Scale (VAS) Score in the Randomized Population at Week 25|EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L VAS. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. The means were derived via an analysis of covariance (ANCOVA) model and have been adjusted for the following co-variates: baseline score, treatment group, and treatment by baseline interaction term.|Baseline, Week 25|Participants randomized to Arms A, B, and C. The number analyzed represents participants who provided responses at Baseline and Week 25.|||units on a scale||Standard Deviation|Mean
2549869|NCT02847637|Secondary|Haem-A-QoL Questionnaire Total Score for Adult Participants (≥18 Years of Age) in the Randomized Population at Week 25|The Haem-A-QoL questionnaire has been developed and used in hemophilia A participants, assessing very specific aspects of dealing with hemophilia. The questionnaire consists of items pertaining to 10 domains: physical health, sports and leisure, school and work, dealing with hemophilia, family planning, feeling, relationships, treatment, view of yourself, and outlook for the future. The total score for each domain ranges from 0 to 100 with lower scores reflective of better quality of life. Haem-A-QoL Total Score is the average of all domain scores and it ranges from 0 to 100, with lower scores reflective of better quality of life. The means were derived via an analysis of covariance (ANCOVA) model and have been adjusted for the following co-variates: baseline score, treatment group, and treatment by baseline interaction term.|Baseline, Week 25|Adult participants randomized to Arms A, B, and C. The number analyzed represents participants who provided responses at Baseline and Week 25.|||units on a scale||Standard Deviation|Mean
2549870|NCT02847637|Secondary|Hemophilia A Quality of Life (Haem-A-QoL) Questionnaire Physical Health Subscore for Adult Participants (≥18 Years of Age) in the Randomized Population at Week 25|The Haem-A-QoL questionnaire has been developed and used in hemophilia A participants, assessing very specific aspects of dealing with hemophilia. The questionnaire consists of items pertaining to 10 domains: physical health, sports and leisure, school and work, dealing with hemophilia, family planning, feeling, relationships, treatment, view of yourself, and outlook for the future. The total score for each domain ranges from 0 to 100 with lower scores reflective of better quality of life. Physical Health domain score is reported (range 0 to 100, with lower scores reflective of better physical health). The means were derived via an analysis of covariance (ANCOVA) model and have been adjusted for the following co-variates: baseline score, treatment group, and treatment by baseline interaction term.|Baseline, Week 25|Adult participants randomized to Arms A, B, and C. The number analyzed represents participants who provided responses at Baseline and Week 25.|||units on a scale||Standard Deviation|Mean
2549871|NCT02847637|Secondary|Intra-Participant Comparison of ABR for All Bleeds on Study Versus Pre-Study in Participants From the NIS Population Previously Treated With Episodic FVIII (NISE)|"This is an intra-participant comparison of the annualized bleeding rate (ABR) for all bleeds on study versus pre-study in the NIS population previously treated with episodic FVIII in NIS BH29768. The number of all bleeds over the efficacy period is presented as an ABR that was assessed using a NB regression model, which accounts for different follow-up times, with the participant's number of bleeds as a function of treatment and the time that each participant stays in the study (i.e., length of the efficacy period) included as an offset in the model. The model also includes a repeated statement to account for intra-participant comparison. All bleeds comprises both treated and non-treated bleeds. In this definition, all bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded."|24 weeks prior to study entry, Baseline, through at least 24 weeks|Intra-participant comparison in the NIS population previously treated with episodic FVIII (NISE), which includes all participants who had received episodic FVIII in NIS BH29768 prior to study entry in Arms A and B (pooled data).|||all bleed rate per year||95% Confidence Interval|Number
2549872|NCT02847637|Secondary|Intra-Participant Comparison of ABR for Treated Bleeds on Study Versus Pre-Study in Participants From the NIS Population Previously Treated With Episodic FVIII (NISE)|"This is an intra-participant comparison of the annualized bleeding rate (ABR) for treated bleeds on study versus pre-study in the NIS population previously treated with episodic FVIII in NIS BH29768. The number of treated bleeds over the efficacy period is presented as an ABR that was assessed using a NB regression model, which accounts for different follow-up times, with the number of bleeds as a function of treatment and the time that each participant stays in the study (i.e., length of the efficacy period) included as an offset in the model. The model also includes a repeated statement to account for intra-participant comparison. A bleed is considered a treated bleed if it is directly followed (i.e., no intervening bleed) by a hemophilia medication reported to be a treatment for bleed, irrespective of the time between treatment and the preceding bleed. Bleeds due to surgery/procedure are excluded."|24 weeks prior to study entry, Baseline, through at least 24 weeks|Intra-participant comparison in the NIS population previously treated with episodic FVIII (NISE), which includes all participants who had received episodic FVIII in NIS BH29768 prior to study entry in Arms A and B (pooled data).|||treated bleed rate per year||95% Confidence Interval|Number
2549895|NCT02847182|Secondary|Incidence of Graft vs. Host Disease||12 months|||||||
2549896|NCT02847182|Secondary|Evidence of Alloimmunization Via Anti-HLA (Human Leukocyte Antigen) and Anti-RBC (Red Blood Cell) Antibodies and Nonspecific Markers of Systemic Inflammation (ESR, CRP)||12 months|||||||
2549873|NCT02847637|Secondary|Intra-Participant Comparison of ABR for All Bleeds on Study Versus Pre-Study in Participants From the Non-Interventional Study Population Previously Treated With FVIII Prophylaxis (NISP)|"This is an intra-participant comparison of the annualized bleeding rate (ABR) for all bleeds on study versus pre-study in the NIS population previously treated with FVIII prophylaxis in NIS BH29768. The number of all bleeds over the efficacy period is presented as an ABR that was assessed using a NB regression model, which accounts for different follow-up times, with the participant's number of bleeds as a function of treatment and the time that each participant stays in the study (i.e., length of the efficacy period) included as an offset in the model. The model also includes a repeated statement to account for intra-participant comparison. All bleeds comprises both treated and non-treated bleeds. In this definition, all bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded."|24 weeks prior to study entry, Baseline, through at least 24 weeks|Intra-participant comparison in the NIS population previously treated with FVIII prophylaxis (NISP), which includes all participants who had received FVIII prophylaxis in NIS BH29768 prior to study entry in Arm D.|||all bleed rate per year||95% Confidence Interval|Number
2549874|NCT02847637|Secondary|Intra-Participant Comparison of ABR for Treated Bleeds on Study Versus Pre-Study in Participants From the Non-Interventional Study Population Previously Treated With Factor VIII (FVIII) Prophylaxis (NISP)|"This is an intra-participant comparison of the annualized bleeding rate (ABR) for treated bleeds on study versus pre-study in the NIS population previously treated with FVIII prophylaxis in NIS BH29768. The number of treated bleeds over the efficacy period is presented as an ABR that was assessed using a NB regression model, which accounts for different follow-up times, with the number of bleeds as a function of treatment and the time that each participant stays in the study (i.e., length of the efficacy period) included as an offset in the model. The model also includes a repeated statement to account for intra-participant comparison. A bleed is considered a treated bleed if it is directly followed (i.e., no intervening bleed) by a hemophilia medication reported to be a treatment for bleed, irrespective of the time between treatment and the preceding bleed. Bleeds due to surgery/procedure are excluded."|24 weeks prior to study entry, Baseline, through at least 24 weeks|Intra-participant comparison in the NIS population previously treated with FVIII prophylaxis (NISP), which includes all participants who had received FVIII prophylaxis in NIS BH29768 prior to study entry in Arm D.|||treated bleed rate per year||95% Confidence Interval|Number
2549875|NCT02847637|Secondary|Annualized Bleeding Rate (ABR) for Treated Target Joint Bleeds|"The number of treated target joint bleeds over the efficacy period is presented as an annualized bleeding rate (ABR) that was assessed using a NB regression model, which accounts for different follow-up times, with the patient's number of bleeds as a function of randomization and the time that each patient stays in the study (i.e., length of the efficacy period) included as an offset in the model. The model also includes the number of bleeds (<9 or ≥9) in the last 24 weeks prior to study entry as a stratification factor. A target joint bleed is defined as a bleed reported as a joint bleed into a target joint, defined as at least 3 bleeds into the same joint during the last 24 weeks prior to study entry. It is considered a treated target joint bleed if it is directly followed (i.e., no intervening bleed) by a hemophilia medication reported to be a treatment for bleed. Bleeds due to surgery/procedure are excluded."|From Baseline to at least 24 weeks|All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.|||treated target joint bleed rate per year||95% Confidence Interval|Number
2549876|NCT02847637|Secondary|Annualized Bleeding Rate (ABR) for Treated Spontaneous Bleeds|"The number of treated spontaneous bleeds over the efficacy period is presented as an annualized bleeding rate (ABR) that was assessed using a NB regression model, which accounts for different follow-up times, with the patient's number of bleeds as a function of randomization and the time that each patient stays in the study (i.e., length of the efficacy period) included as an offset in the model. The model also includes the number of bleeds (<9 or ≥9) in the last 24 weeks prior to study entry as a stratification factor. A bleed is classified as spontaneous if there is no other known contributing factor such as trauma or procedure/surgery. A treated spontaneous bleed is a spontaneous bleed that is directly followed (i.e., no intervening bleed) by a hemophilia medication reported to be a treatment for bleed. Bleeds due to surgery/procedure are excluded."|From baseline to at least 24 weeks|All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.|||treated spontaneous bleed rate per year||95% Confidence Interval|Number
2549877|NCT02847637|Secondary|Annualized Bleeding Rate (ABR) for Treated Joint Bleeds|"The number of treated joint bleeds over the efficacy period is presented as an annualized bleeding rate (ABR) that was assessed using a NB regression model, which accounts for different follow-up times, with the patient's number of bleeds as a function of randomization and the time that each patient stays in the study (i.e., length of the efficacy period) included as an offset in the model. The model also includes the number of bleeds (<9 or ≥9) in the last 24 weeks prior to study entry as a stratification factor. A joint bleed is defined as a bleed reported as joint and with at least one of the following symptoms: increasing swelling or warmth of the skin over the joint; and/or increasing pain, decreased range of motion, or difficulty using the joint compared with baseline. It is considered a treated joint bleed if it is directly followed (i.e., no intervening bleed) by a hemophilia medication reported to be a treatment for bleed. Bleeds due to surgery/procedure are excluded."|From Baseline to at least 24 weeks|All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.|||treated joint bleed rate per year||95% Confidence Interval|Number
2549878|NCT02847637|Secondary|Annualized Bleeding Rate (ABR) for All Bleeds|"The number of all bleeds over the efficacy period is presented as an annualized bleeding rate (ABR) that was assessed using a NB regression model, which accounts for different follow-up times, with the patient's number of bleeds as a function of randomization and the time that each patient stays in the study (i.e., length of the efficacy period) included as an offset in the model. The model also includes the number of bleeds (<9 or ≥9) in the last 24 weeks prior to study entry as a stratification factor. All bleeds comprises both treated and non-treated bleeds. In this definition, all bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded."|From Baseline to at least 24 weeks|All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.|||all bleed rate per year||95% Confidence Interval|Number
2549897|NCT02847182|Secondary|Severity of Product-related Infections|Grade/severity will be assessed according to CTCAE v4.0 guidelines|12 months|||||||
2549879|NCT02847637|Primary|Annualized Bleeding Rate (ABR) for Treated Bleeds|"The number of treated bleeds over the efficacy period is presented as an annualized bleeding rate (ABR) that was assessed using a negative binomial (NB) regression model, which accounts for different follow-up times, with the number of bleeds as a function of randomization and the time that each participant stays in the study (i.e., length of the efficacy period) included as an offset in the model. The model also includes the number of bleeds (<9 or ≥9) in the last 24 weeks prior to study entry as a stratification factor. A bleed is considered a treated bleed if it is directly followed (i.e., no intervening bleed) by a hemophilia medication reported to be a treatment for bleed, irrespective of the time between treatment and the preceding bleed. Bleeds due to surgery/procedure are excluded."|From Baseline to at least 24 weeks|All participants, which includes those randomized to Arms A, B, and C, and those enrolled in Arm D of the study.|||treated bleed rate per year||95% Confidence Interval|Number
2549880|NCT02847494|Secondary|Medication Preference as Assessed by Self-report|"Participants will be asked, by phone, if they would want the same medication during a subsequent visit to the emergency department. Reported values indicate participants who responded yes."|7 days after discharge from emergency department||||Participants|||Count of Participants
2549881|NCT02847494|Secondary|Number of Participants With Sustained Headache Freedom|Sustained headache freedom is defined as achieving a headache intensity = none within two hours of treatment and maintaining this level, without requiring additional headache medication, for 7 days following discharge from the Emergency Department. Participants will be asked by phone how number of days they experienced headaches during the week after discharge from the emergency department. Reported values are participants who experienced no headaches at all during the 7 days immediately following discharge.|7 days after discharge from emergency department||||Participants|||Count of Participants
2549882|NCT02847494|Primary|Headache Days as Self-reported by Participants|At the seven day follow-up, participants will be asked by phone how many days they experienced headaches since being discharged.|7 days after discharge from emergency department||||days||95% Confidence Interval|Mean
2549883|NCT02847260|Secondary|Change From Baseline to Week 16 in HemodynamicParameters: Pulmonary Vascular Resistance Index (PVRI) (mmHg*Min*m^2/L)|Pulmonary Vascular Resistance Index (PVRI) is calculated using Mean Pulmonary Arterial Pressure(PAPm), Pulmonary Capillary Wedge Pressure (PCWP) and Cardiac Index (CI ), to provide information about right ventricular load. The PVRI values and their respective changes from Baseline to Week 16 were measured by SwanGanz right heart catheterization.|Baseline to week 16|Only 29 of the 32 subjects that completed the 16 week treatment period completed these hemodynamic assessments.|||mmHg*min*m^2/L||Standard Deviation|Mean
2549884|NCT02847260|Secondary|Change From Baseline to Week 16 in Hemodynamic Parameters: Cardiac Index (CI) (L/Min/m^2)|Cardiac Index (CI) relates the cardiac output (CO) to body surface area (BSA), thus relating heart performance to the size of the individual. The CI values and their respective changes from Baseline to Week 16 were measured by SwanGanz right heart catheterization and summarized.|Baseline to week 16|Only 29 of the 32 subjects that completed the 16 week treatment period completed these hemodynamic assessments.|||L/min/m^2||Standard Deviation|Mean
2549885|NCT02847260|Secondary|Change From Baseline to Week 16 in Hemodynamic Parameters: Mean Pulmonary Artery Pressure (PAPm), Mean Right Atrial Pressure (RAPm) and Mean Pulmonary Capillary Wedge Pressure (PCWPm).|Pulmonary hypertension, an increase in pressure in the pulmonary vasculature defined as a mean pulmonary artery pressure (PAPm) greater than 25 mmHg at rest or greater than 30 mmHg with exercise, as measured by Swan-Ganz right heart catheterization. The PAPm, RAPm and PCWPm values and their respective changes from Baseline to Week 16 were measured by SwanGanz right heart catheterization and summarized.|Baseline to week 16|Only 29 of the 32 subjects that completed the 16 week treatment period completed these hemodynamic assessments.|||mmHG||Standard Deviation|Mean
2549886|NCT02847260|Secondary|Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 16.|The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning) and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, negative change scores indicate improvements.|Baseline to week 16|Scores could not be tabulated for one subject due to missing responses to individual questions|||units on a scale||Full Range|Median
2549887|NCT02847260|Secondary|Number of Participants With a Change From Baseline World Health Organization (WHO) Functional Classification at Week 16.|The WHO Functional Class of pulmonary hypertension is a physical activity rating scale as follows: Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.|Baseline to week 16||||Participants|||Count of Participants
2549888|NCT02847260|Secondary|Change in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations From Baseline to Week 16.|The level of this biomarker of the (NT-proBNP) serum concentration was assessed to compare the severity of heart failure at Baseline and Week 16.|Baseline to week 16||||pg/mL||Full Range|Median
2549889|NCT02847260|Secondary|Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 16|The Borg dyspnea score is a 10 point scale rating the maximum level of dyspnea (difficulty in breathing) experienced during the 6MWT. The Borg dyspnea score was assessed immediately following the 6MWT. Scores range from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced).|Baseline to week 16|Two subjects that completed the treatment period did not complete the six minute walk test at week 16. As such, the evaluable data for the six minute walk test at Week 16 was summarized using an N of 30 subjects.|||units on a scale||Full Range|Median
2549890|NCT02847260|Secondary|Change From Baseline in Six Minute Walk Distance at Week 16.|The purpose of the six minute walk test (6MWT) was to evaluate exercise capacity associated with carrying out activities of daily living. Patients were instructed to walk down a corridor at a comfortable speed as far as they could manage for six minutes, resting whenever they needed. Distance <500 meters suggests considerable exercise limitation; Distance 500 - 800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.|Baseline to week 16|Two subjects that completed the treatment period did not complete the six minute walk test at week 16. As such, the evaluable data for the six minute walk test at Week 16 was summarized using an N of 30 subjects.|||meters||Full Range|Median
2549901|NCT02847182|Secondary|Change in PDD-BI Learning, Memory, and Receptive Language T-Score|The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Learning, Memory, and Receptive Language T-Score (mean=50, standard deviation=10) assesses two areas of variable competence in children with autism: (a) memory and (b) receptive language. The score ranges from 22 to 88 for participants aged 2-8 years. Higher values indicate increasing levels of competence. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect improvement, decreases indicate worsening, and zero indicates no change.|Baseline, Month 6|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||T score||Standard Deviation|Mean
2549902|NCT02847182|Secondary|Change in PDD-BI Expressive Language T-Score|The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Expressive Language T-Score (mean=50, standard deviation=10) assesses the ability of the child to speak the sounds associated with the English language and to use words and sentences that indicate his or her competence with grammar, tone of voice, and the pragmatic aspects of communicating with others. The score ranges from 28 to 100 for participants aged 2-8 years. Higher values indicate increasing levels of competence. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect improvement, decreases indicate worsening, and zero indicates no change.|Baseline, Month 6|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||T score||Standard Deviation|Mean
2549903|NCT02847182|Secondary|Change in PDD-BI Social Approach Behaviors T-Score|The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Social Approach Behaviors T-Score (mean=50, standard deviation=10) assesses those social communication skills that are notoriously difficult for children with autism (e.g., eye contact, joint attention, effective use of gesture, imaginative skills). The score ranges from 14 to 93 for participants aged 2-8 years. Higher values indicate increasing levels of competence. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect improvement, decreases indicate worsening, and zero indicates no change.|Baseline, Month 6|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||T score||Standard Deviation|Mean
2549904|NCT02847182|Secondary|Change in PDD-BI Receptive/Expressive Social Communication Ability T-Score|The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Receptive/Expressive Social Communication Ability T-Score (mean=50, standard deviation=10) measures a broad range of social communication skills affected by autism. The score ranges from 20 to 100 for participants aged 2-8 years. Higher values indicate increasing levels of competence. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect improvement, decreases indicate worsening, and zero indicates no change.|Baseline, Month 6|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||T score||Standard Deviation|Mean
2549905|NCT02847182|Secondary|Change in PDD-BI Expressive Social Communication Abilities T-Score|The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Expressive Social Communication Abilities T-Score (mean=50, standard deviation=10) measures a broad range of social communication skills affected by autism. The score ranges from 20 to 100 for participants aged 2-8 years. Higher values indicate increasing levels of competence. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect improvement, decreases indicate worsening, and zero indicates no change.|Baseline, Month 6|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||T score||Standard Deviation|Mean
2549906|NCT02847182|Secondary|Change in PDD-BI Aggressiveness T-Score|The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Aggressiveness T-Score (mean=50, standard deviation=10) assesses the aggressive approach toward self or others, as well as the negative mood changes that are often associated with such behaviors. The score ranges from 36 to 100 for participants aged 2-8 years. Higher values indicate increasing levels of severity. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect worsening of problem behaviors, decreases indicate improvement, and zero indicates no change.|Baseline, Month 6|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||T score||Standard Deviation|Mean
2549907|NCT02847182|Secondary|Change in PDD-BI Specific Fears T-Score|The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Specific Fears T-Score (mean=50, standard deviation=10) measures behaviors that communicate the fears and anxieties associated with withdrawal from social or asocial stimuli. The score ranges from 36 to 100 for participants aged 2-8 years. Higher values indicate increasing levels of severity. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect worsening of problem behaviors, decreases indicate improvement, and zero indicates no change.|Baseline, Month 6|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||T score||Standard Deviation|Mean
2549933|NCT02846792|Secondary|Toxicity Rates|Overall Percentage and number of patients experiencing grade 3 or higher severity of adverse events, graded using the National Cancer Institute Common Toxicity Criteria version 4.0.|Adverse events collected from the time patient received the first dose of study therapy through 28 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 28 days post therapy.||||Participants|||Count of Participants
2549908|NCT02847182|Secondary|Change in PDD-BI Arousal Regulation Problems T-Score|The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Arousal Regulation Problems T-Score (mean=50, standard deviation=10) measures behaviors that are largely non-communicative or unresponsive and reflect emotional constriction, the apparent seeking of kinesthetic sensation, and, in the parent version, difficulty with sleep regulation. The score ranges from 26 to 77 for participants aged 2-8 years. Higher values indicate increasing levels of severity. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect worsening of problem behaviors, decreases indicate improvement, and zero indicates no change.|Baseline, Month 6|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||T score||Standard Deviation|Mean
2549909|NCT02847182|Secondary|Change in PDD-BI Semantic/Pragmatic Problems T-Score|The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Semantic/Pragmatic Problems T-Score (mean=50, standard deviation=10) assesses the difficulties children with autism have in using spoken language to indicate comprehension, communicate meaning, respond to the interests of others, and sustain a conversation. The score ranges from 34 to 100 for participants aged 2-8 years. Higher values indicate increasing levels of severity. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect worsening of problem behaviors, decreases indicate improvement, and zero indicates no change.|Baseline, Month 6|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||T score||Standard Deviation|Mean
2549910|NCT02847182|Secondary|Change in PDD-BI Social Pragmatic Problems T-Score|The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Social Pragmatic Problems T-Score (mean=50, standard deviation=10) measures the difficulties children with autism have in either reacting to the approaches of others, understanding social conventions, or initiating social interactions with others. The score ranges from 29 to 100 for participants aged 2-8 years. Higher values indicate increasing levels of severity. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect worsening of problem behaviors, decreases indicate improvement, and zero indicates no change.|Baseline, Month 6|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||T score||Standard Deviation|Mean
2549911|NCT02847182|Secondary|Change in PDD-BI Ritualisms/Resistance to Change T-Score|The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Ritualisms/Resistance to Change T-Score (mean=50, standard deviation=10) describes behaviors that communicate the child's desires to carry out rituals or to communicate dissatisfaction with a change in the environment or routine. The score ranges from 34 to 100 for participants aged 2-8 years. Higher values indicate increasing levels of severity. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect worsening of problem behaviors, decreases indicate improvement, and zero indicates no change.|Baseline, Month 6|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||T score||Standard Deviation|Mean
2549912|NCT02847182|Secondary|Change in PDD-BI Sensory/Perceptual Approach Behaviors T-Score|The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Sensory/Perceptual Approach Behaviors T-score (mean=50, standard deviation=10) includes behaviors that are largely non-communicative and involve approach toward asocial stimuli. The score ranges from 31 to 86 in patients aged 2-8 years. Higher values indicate increasing levels of severity. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect worsening of problem behaviors, decreases indicate improvement, and zero indicates no change.|Baseline, Month 6|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||T score||Standard Deviation|Mean
2549913|NCT02847182|Secondary|Change in PDD-BI Approach/Withdrawal Problems T-Score|The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Approach/Withdrawal Problems T-Score (mean=50, standard deviation=10) measures a broad range of behavioral problems associated with autism. The score ranges from 27-100 in patients aged 2-8 years. Higher values indicate increasing levels of severity. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect worsening of problem behaviors, decreases indicate improvement, and zero indicates no change.|Baseline, Month 6|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||T score||Standard Deviation|Mean
2549914|NCT02847182|Secondary|Change in Pervasive Developmental Disorder Behavior Inventory (PDD-BI) Repetitive, Ritualistic and Pragmatic Problems T-Score|The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The Repetitive, Ritualistic and Pragmatic Problems T-Score (mean=50, standard deviation=10) measures a broad range of behavioral problems associated with autism. The score ranges from 26-100 in patients aged 2-8 years. Higher values indicate increasing levels of severity. The change in this score from Baseline to Month 6 was calculated for each participant. Increases in the change score reflect worsening of problem behaviors, decreases indicate improvement, and zero indicates no change.|Baseline, Month 6|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||T score||Standard Deviation|Mean
2549934|NCT02846792|Secondary|Overall Survival|Will be summarized using descriptive statistics (mean, standard deviation, median, minimum and maximum values).|Time between receipt of first study drug until death date or last known alive date, assessed up to 16 months|Study terminated (stopped prematurely). Immunotherapy approved for NSCLC in the first line setting.||||||
2549915|NCT02847182|Secondary|Change in Vineland Adaptive Behavior Scales II (VABS-II) Composite Score|The Vineland Adaptive Behavior Scales II (VABS-II) measures adaptive functioning in socialization, communication, daily living, and motor skills. The Adaptive Behavior Composite provides an overall summary of adaptive behavior across all of the domains. Each participant's score is standardized to a normal distribution with mean=100 and standard deviation=15. Positive scores indicate an increase in the Adaptive Behavior Composite Score over time whereas negative scores indicate decrease in the Adaptive Behavior Composite Score, and zero indicates no change in the Adaptive Behavior Composite Score.|Baseline, 6 months|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||score on a scale||Standard Deviation|Mean
2549916|NCT02847182|Secondary|Change in Vineland Adaptive Behavior Scales II (VABS-II) Daily Living Subscale Standard Score|The VABS-II measures adaptive functioning in socialization, communication, daily living, and motor skills. The Daily Living standard score is derived by summing norm-referenced (by age group and sex) v-scale scores (mean=15, standard deviation=3) from the Personal, Domestic and Community subdomains and standardizing this sum to a normal distribution with mean=100 and standard deviation=15. Changes in the Daily Living standard score are indicative of skill acquisition relative to chronologically aged peers of the same sex. Thus, a zero (no change) represents change consistent with what is expected. An increase represents acquisition of more skills over time than would be expected. Participants who experience a decrease in Daily Living standard score may still have acquired skills although not at the rate expected based on their age and sex.|Baseline, 6 months|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||score on a scale||Standard Deviation|Mean
2549917|NCT02847182|Secondary|Change in Vineland Adaptive Behavior Scales II (VABS-II) Communication Subscale Standard Score|The VABS-II measures adaptive functioning in socialization, communication, daily living, and motor skills. The Communication subscale standard score is derived by summing norm-referenced (by age group and sex) v-scale scores (mean=15, standard deviation=3) from the Receptive, Expressive, and Written communication subdomains and standardizing this sum to a normal distribution with mean=100 and standard deviation=15. Changes in the Communication standard score are indicative of skill acquisition relative to chronologically aged peers of the same sex. Thus, a zero (no change) represents change consistent with what is expected. An increase represents acquisition of more skills over time than would be expected. Participants who experience a decrease in Communication standard score may still have acquired skills although not at the rate expected based on their age and sex.|Baseline, 6 months|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||score on a scale||Standard Deviation|Mean
2549918|NCT02847182|Secondary|Change in Expressive One-Word Picture Vocabulary Test (Clinician Assessment)|This Expressive One-Word Picture Vocabulary Test is a standardized evaluation of the child's expressive one-word vocabulary by a trained clinician. It tests an individual's ability to name, with one word, objects, actions, and concepts when presented with color illustrations. Higher EOWPVT standard scores reflect a better vocabulary. The minimum score is age-dependent (years:months) as follows. For a child age 2:0 to 2:1 the minimum is 65; age 2:2-2:3 (min=62); age 2:4-2:5 (min=60); age 2:6-2:7 (min=58); age 2:8-2:9 (min=57); age 2:10-2:11 (min=56); age 3:0 and older (min=55). The maximum possible score across all ages is 145. The change in score from Baseline to Month 6 was the outcome measure. Increases reflect increases in vocabulary skills, decreasing reflect decreases in vocabulary skills, and zero reflects no change.|Baseline, 6 months|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment. Three additional subjects were excluded from the Cord Blood group because they were missing assessments.|||score on a scale||Standard Deviation|Mean
2549919|NCT02847182|Secondary|Clinical Global Impressions - Global Improvement (CGI-I) Score, Clinician Assessment|The CGI-I is a 7 point scale that requires the clinician to assess how much the participant's autism symptoms have improved or worsened relative to a baseline assessment. The symptoms are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. There are three separate CGI-I ratings: social communicative functioning, restricted/repetitive interests and behaviors, and overall improvement.|Baseline, 6 months|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment. Two additional subjects were excluded from the Cord Blood group because they were missing assessments.|||Participants|||Count of Participants
2549920|NCT02847182|Secondary|Change in Clinical Global Impressions - Severity of Illness (CGI-S) Score, Clinician Assessment|The CGI-S is a 7 point scale completed at the baseline and 6-month visits that requires the clinician to rate the severity of the participant's symptoms of autism at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. There are 3 CGI-S scores: the Social Communication Score, the Restricted and Repetitive Behaviors Score, and the Overall Score. The clinician's rates the severity of autism symptoms - 1, normal, no symptoms; 2, borderline level of symptoms; 3, mild symptoms; 4, moderate symptoms; 5, marked symptoms; 6, severe symptoms; or 7, extremely severe symptoms. Increases in the change score represent increases in symptom severity, decreases in the change score indicate improvement, and zero indicates no change.|Baseline, 6 months|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment. Two additional subjects were excluded from the Cord Blood group because they were missing assessments.|||score on a scale||Standard Deviation|Mean
2549935|NCT02846792|Secondary|Duration of Response|Will be summarized using descriptive statistics (mean, standard deviation, median, minimum and maximum values).|Time between receipt of first study drug until disease progression date, unacceptable toxicity or withdrawal of patient consent, assessed up to 16 months|Study terminated (stopped prematurely). Immunotherapy approved for NSCLC in the first line setting.||||||
2550153|NCT02839876|Secondary|Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)|Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).|48 hours||||score on a scale||Inter-Quartile Range|Median
2549921|NCT02847182|Secondary|Change in Pervasive Developmental Disorder Behavior Inventory (PDD-BI) Composite Standard Score (Parent Questionnaire)|The PDD-BI is an informant-based rating scale that assesses problem behaviors as well as appropriate social, language, and learning/memory skills. The PDD-BI assesses both social impairments and development of pro-social skills that are integral to improved reciprocal social behavior. The PDD-BI renders T scores (mean=50, standard deviation=10) based on comparisons to a standardized ASD population. The Autism Composite T score ranges from 10-100. The typical child with autism scores between 40-60.Higher scores indicate more severe autism symptoms and lower scores reflect milder symptoms. Change in this score from Baseline to Month 6 was calculated for each participant. Negative change scores indicate improvement in autism symptoms over time whereas positive scores indicate worsening of symptoms, and zero indicates no change in symptoms.|Baseline, 6 months|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||score on a scale||Standard Deviation|Mean
2549922|NCT02847182|Secondary|Change in Vineland Socialization Domain Age Equivalent|There are 3 age equivalent scores within the Socialization domain of the VABS-3: the Interpersonal Relationships Age Equivalent, the Play and Leisure Age Equivalent, and the Coping Sills Age Equivalent. An individual participant's age equivalent represents the chronological age (in years:months) at which their score would be considered normative. The age equivalent ranges are 0:0-22:0, 0:0-20:0, and 2:0-22:0 for the Interpersonal Relationships, Play and Leisure and Coping Skills age equivalents, respectively. The change in this age equivalent was calculated for each participant from Baseline to Month 6 and expressed as a number of months. Positive scores indicate increases in the age equivalent of the participant's social communication skills over time and are considered an improvement. Negative scores indicate decreases in the age equivalent of the participant's social communication skills and are considered worsening, and zero indicates no change.|Baseline, 6 months|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||months||Standard Deviation|Mean
2549923|NCT02847182|Secondary|Change in Vineland Socialization Domain Raw Score|There are 3 raw scores within the Socialization domain of the VABS-3. These are the Interpersonal Relationships Raw Score (range: 0-86), the Play and Leisure Raw Score (range: 0-72), and the Coping Skills Raw Score (range: 0-66). Higher numbers on all three scores reflect better functioning in each area. Each raw score is the sum of the item scores in the respective subdomain of Socialization skills. The items are scored as follows: 2=usually present, 1=sometimes present, 0= never present. The item scores are assigned by a trained interviewer who interviews the parent of the child participating in the study. The change in raw score was calculated for each participant from Baseline to Month 6. Positive scores indicate improvement over time whereas negative scores indicate worsening, and zero indicates no change. The scores are not norm-referenced.|Baseline, 6 months|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||score on a scale||Standard Deviation|Mean
2549924|NCT02847182|Primary|Change in Social Communication as Measured by the Vineland Adaptive Behavior Scales, Third Edition (VABS-3)|The Vineland Adaptive Behavior Scales, Third Edition (VABS-3) Socialization domain standard score has mean=100 and standard deviation=15 (range: 20-140). Higher scores indicate better developed adaptive social behavior. The change in the Socialization domain standard score was calculated for each participant from Baseline to Month 6. Changes in the Socialization standard score are indicative of skill acquisition relative to chronologically aged peers of the same sex. Thus, a zero (no change) represents change consistent with what is expected. An increase represents acquisition of more skills over time than would be expected. Participants who experience a decrease in Socialization standard score may still have acquired skills although not at the rate expected based on their age and sex.|Baseline, 6 months|Four subjects randomized to placebo were not included in the efficacy analyses. Two were pre-specified exclusions (defined as pilot subjects in the protocol) and two were found ineligible after enrollment.|||score on a scale||Standard Deviation|Mean
2549925|NCT02847169|Primary|Rotational Recovery in Degrees After 60 Seconds|Rotational recovery measured in degrees after 60 seconds for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and at 1 week by slit lamp.|Baseline and 1 week||||degrees||Standard Deviation|Mean
2549926|NCT02847169|Primary|Lens Orientation in Primary Position of Gaze|Lens rotation for habitual toric lens assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week with slit lamp by measuring within 10 degrees of the axis mark on the lens relative to the desired 6' o'clock position while the subject looked straight ahead.|Baseline and 1 week||||percentage of participants|||Number
2549927|NCT02847169|Primary|Corneal Coverage|Corneal coverage for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (yes=full corneal coverage or no=not full coverage)|Baseline and 1 week||||participants|||Number
2549928|NCT02847169|Primary|Overall Stability|Overall lens stability for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=very poor stability, 4=excellent stability.|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2549929|NCT02847169|Primary|Post-blink Movement|Post-blink movement for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=insufficient, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement.|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2549930|NCT02847169|Primary|Lens Centration|Lens centration for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. (Centered - optimal, decentered slightly, or substantially decentered).|Baseline and 1 week||||percentage of participants|||Number
2549931|NCT02847169|Primary|Overall Fit Acceptance|Investigator's preference for lens fit acceptance for habitual lenses assessed at baseline and filcon IV1 and ocufilcon D toric lenses assessed at baseline and 1 week. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2= minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2549936|NCT02846792|Secondary|Disease Control Rate|Defined as the proportion of patients with complete response, partial response, and stable disease for more than 8 weeks according to Response Evaluation Criteria in Solid Tumors version 1.1.|Time between receipt of first study drug until disease progression date, unacceptable toxicity or withdrawal of patient consent, assessed up to 16 months|Study terminated (stopped prematurely). Immunotherapy approved for NSCLC in the first line setting.||||||
2549937|NCT02846792|Primary|Overall Response Rate (Phase II)|Defined as the sum of complete and partial responses for more than 8 weeks according to Response Evaluation Criteria in Solid Tumors version 1.1.|Time between receipt of first study drug until disease progression date, unacceptable toxicity or withdrawal of patient consent, assessed up to 16 months|Study terminated (stopped prematurely). Immunotherapy approved for NSCLC in the first line setting.||||||
2549938|NCT02846792|Primary|Maximum Tolerated Dose of Plinabulin and Nivolumab (Phase I)|Defined as no more than 1 of 6 patients experiencing a dose limiting toxicity, graded according to the National Cancer Institute Common Toxicity Criteria version 4.0.|Up to 28 days|Study terminated (stopped prematurely). Immunotherapy approved for NSCLC in the first line setting.||||||
2549939|NCT02846779|Secondary|Number of Hospitalizations|Number of All-cause hospitalizations over the entire follow-up period|From 1 month (30 days) after randomization through 12 months (365 days) after randomization||||Hospitalizations||Standard Deviation|Mean
2549940|NCT02846779|Secondary|Number of Emergency Room Visits|Number of all-cause emergency room visits over the entire follow-up period|From 1 month (30 days) after randomization through 12 months (365 days) after randomization||||ER visits||Standard Deviation|Mean
2549941|NCT02846779|Secondary|Number of Physician Office Visits|Number of all-cause physician office visits over the entire follow-up period|From 1 month (30 days) after randomization through 12 months (365 days) after randomization||||Physician office visits||Standard Deviation|Mean
2549942|NCT02846779|Secondary|Health Care Spending|Health care spending includes prescription medications, nondrug medical services, and the combination of these two factors over the entire follow-up period|From 1 month (30 days) after randomization through 12 months (365 days) after randomization||||Dollars||Standard Deviation|Mean
2549943|NCT02846779|Secondary|Change in Glycated Hemoglobin Level (HbA1c)|The percent change in HbA1c level between the latest baseline value to the latest follow up value, among those with at least 1 baseline HbA1c available.|From 1 month (30 days) after randomization through 12 months (365 days) after randomization||||Percent change||Standard Deviation|Mean
2549944|NCT02846779|Primary|Insulin Persistence|Percentage of participants who were non-persistent if they did not refill insulin before a set threshold of time over the entire follow-up period|From 1 month (30 days) after randomization through 12 months (365 days) after randomization||||Percentage of participants|||Number
2549945|NCT02846740|Secondary|Length of Stay||Baseline, 22 months,|This was a difficult analysis considering patients had different motives for staying versus discharge|||Days||Standard Deviation|Mean
2549946|NCT02846740|Primary|Adverse Effects and Safety|Safety of adjunctive cranial electric stimulation (CES), specifically Alpha-Stim®, to reduce suicide risk in psychiatric inpatients through a randomized, double-blind, sham-controlled, clinical trial. The primary safety outcome measure will be responses to an adverse effect assessment questionnaire (GASE questionnaire).|Baseline, 22 months,||||Participants|||Count of Participants
2549947|NCT02846740|Primary|Change From Baseline in the Modifiable Suicide Risk Factors (MSRF's) Global Score|Efficacy of adjunctive cranial electric stimulation (CES), specifically Alpha-Stim®, to reduce suicide risk in psychiatric inpatients through a randomized, double-blind, sham-controlled, clinical trial. The primary efficacy outcome measure will be change in the modifiable suicide risk factors (MSRF's) as indicated by a summed global score from rating scales measuring the MSRFs that include Montgomery-Åsberg Depression Rating Scale (range very severe = 44; severe = 31; moderate = 25; mild = 15; & recovered = 7), Hamilton Anxiety Rating Scale (range of 0-56, <17 indicates mild severity, 18-24, moderate severity & 25-30 severe). Both scales were summed, the full theoretical scale range is 0-116, with higher scores indicating a worse outcome. Due to short hospital stays, we were not able to use Agitated Behavior Scale and Pittsburgh Sleep Quality Index scale in a meaningful manner to include in our analysis, so we did not include that scale.|Baseline, 22 months,|Many patients were discharged within a few days of admission, some left in two days, which left us with just baseline and several missing scales.|||score on a scale||Standard Deviation|Mean
2549948|NCT02846714|Secondary|Acceptability of Intervention Assessed Via Questionnaire|"In these next 15 questions, we want to learn more about your thoughts about what you learned through the FLARE sessions you've had with us in-person and via WebEx or phone. Please indicate how much you agree with each statement. 15 total constructs summed, each was on the same 5 point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree).~Minimum value = 1; Maximum Value = 75; higher score means a better outcome (better acceptability)"|Week 9|Outcomes for parents (n=21) are from parent self-report of acceptability; outcomes for children (n=21) are from child self-report of acceptability|||units on a scale||Standard Deviation|Mean
2549949|NCT02846714|Secondary|Skin Self-exam Behavior Changes|"Mean difference for frequency of skin self-exam and thoroughness of skin self-exam (measured by number of body parts examined) from Week 1 (pre-intervention) to Week 9 (post-intervention) and from Week 9 to Week 13 (1 month follow-up). (SSE = skin self-exam)~Change in frequency of SSE: In the past month, how often did you check your skin for any new or changed moles or growths? 1 = SSE less than once a month, 2 = SSE once a month, 3 = SSE more than once a month; higher mean difference indicates a better outcome.~Change in thoroughness of SSE: In the past month, which of the body parts listed below were checked for any new or changed moles or growths Minimum value = 0 (checked 0 body parts during SSE); Maximum value = 15 (checked 15 body parts during SSE); higher mean difference indicates a better outcome"|Weeks 1,9,13|Outcomes for parents (n=21) are from parent self-report skin self-exam behavior changes; outcomes for children (n=21) are from parent report on child's skin self-exam behavior changes|||units on a scale||Standard Deviation|Mean
2549978|NCT02844998|Primary|Premature Ejaculation Diagnostic Tool (Total Score)|Premature Ejaculation Diagnostic Tool (PEDT) includes five items; control, frequency, minimal stimulation, distress, and interpersonal difficulty. In this classification tool, equal to or less than scores 8 indicates no PE, scores 9 and 10 indicate possible PE, and scores equal or higher than 11 indicates PE. Total score is between 2 and 22.|Baseline and 30 Days||||scores on a scale||Standard Deviation|Mean
2549950|NCT02846714|Secondary|Photoprotection Behavior Changes Assessed Via Questionnaire|"Mean difference for each photoprotection behavior from Week 1 (pre-intervention) to Week 9 (post-intervention) and from Week 9 to Week 13 (1 month follow-up).~These next questions ask about what you have done in the past month if you were outdoors in the sun for 15 minutes or more. How often did you... Minimum value = 1; Maximum value = 5; A higher mean difference indicates a better outcome"|Weeks 1,9,13|Outcomes for parents (n=21) are from parent self-report of behavior; outcomes for children (n=21) are from parent report on child's behavior|||score on a scale||Standard Deviation|Mean
2549951|NCT02846714|Secondary|Degree of Tan on Skin Assessed Via Reflectance Spectroscopy|Mean degree of tan on skin assessed via reflectance spectroscopy of 4 different body parts (exposed wrist, outer arm, chin, and face) at each time frame. Measurements were taken using a spectrophotometer to quantify skin color. Melanin index values were recorded, with a higher value representing more melanin in the skin (i.e., darker skin).|Weeks 1 (baseline),9,13|Outcomes for parents (n=21) are from parent's reflectance spectroscopy of skin; outcomes for children (n=21) are from child's reflectance spectroscopy of skin|||Melanin Index Values||Standard Deviation|Mean
2549952|NCT02846714|Secondary|Ultraviolet Radiation (UVR) Exposure Assessed Via PALE Questionnaire|Protection-Adjusted Length of Exposure Index (PALE) Assesses UVR exposure during reported activities to yield daily minutes of unprotected sun exposure during each time frame|Weeks 1 (baseline), 3,5,7,9,13|Outcomes for parents (n=21) are from parent self-report of daily minutes of unprotected sun exposure; outcomes for children (n=21) are from parent report on child's daily minutes of unprotected sun exposure|||minutes||Standard Deviation|Mean
2549953|NCT02846714|Secondary|Ultraviolet Radiation (UVR) Exposure Assessed Via Dosimeter Device|Change of weekly average UV intake from Week 1 (baseline) to Week 9 (post-intervention) and from Week 9 to Week 13 (1-month follow up)|Weeks 1 (baseline),9,13||||Joules/meter^2||Standard Error|Mean
2549954|NCT02846714|Secondary|Sunburn Occurrence Assessed Via Questionnaire|Number of participants who received a sunburn during each time frame.|Weeks 1 (baseline), 3,5,7,9,13|Outcomes for parents (n=21) are from parent self-report of sunburns; outcomes for children (n=21) are from parent report on child's sunburns|||Participants|||Count of Participants
2549955|NCT02846714|Secondary|Sunburn Occurrence Assessed Via Diary|Number of participants who got a sunburn during each time frame interval|Weeks 1 (baseline), 3,5,7,9,13|Outcomes for parents (n=21) are from parent self-report of sunburn occurrence; outcomes for children (n=21) are from child self-report of sunburn occurrence|||Participants|||Count of Participants
2549956|NCT02846714|Secondary|Skin Self-exam Occurrence Assessed Via Diary|Number of participants who received a skin self-exam during each time frame interval|Weeks 1 (baseline), 3,5,7,9,13|Outcomes for parents (n=21) are from parent self-report of skin self-exam; outcomes for children (n=21) are from child self-report of skin self-exam|||Participants|||Count of Participants
2549957|NCT02846714|Secondary|Skin Self-exam Occurrence Assessed Via Questionnaire|Number of participants who received a skin self-exam during each time frame|Weeks 1 (baseline), 3,5,7,9,13|Outcomes for parents (n=21) are from parent self-report of skin self-exam; outcomes for children (n=21) are from parent report on child's skin self-exam|||Participants|||Count of Participants
2549958|NCT02846714|Secondary|Photoprotective Behaviors Assessed With the PALE Questionnaire|Protection-Adjusted Length of Exposure Index (PALE) Assesses photoprotective behavior during reported activities to yield daily minutes of unprotected sun exposure during each time frame|Weeks 1 (baseline), 3,5,7,9,13|Outcomes for parents (n=21) are from parent self-report of daily minutes of unprotected sun exposure; outcomes for children (n=21) are from parent report on child's daily minutes of unprotected sun exposure|||minutes||Standard Deviation|Mean
2549959|NCT02846714|Secondary|Photoprotective Behaviors Assessed With the Sun Habits Survey|"These next questions ask about what you have done in the past month if you were outdoors in the sun for 15 minutes or more. How often did you... Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome"|Weeks 1 (baseline), 3,5,7,9,13|Outcomes for parents (n=21) are from parent self-report of behavior; outcomes for children (n=21) are from parent report on child's behavior|||units on a scale||Standard Deviation|Mean
2549960|NCT02846714|Primary|Percent of Participants Retained Throughout Intervention as Assessed by Session Attendance Recorded by Interventionist|Session attendance will be recorded by the interventionist at each scheduled session. The percent of participants who are retained throughout the 3 session intervention will be calculated.|Week 9 (post-intervention)||||Participants|||Count of Participants
2549961|NCT02846558|Secondary|Self-esteem|The Rosenberg Self-Esteem Scale (RSES) is a 10-item scale that measures global self-worth using a 4-point Likert scale to ask about negative and positive feelings about the self. Individual items are summed to calculate the total score. Minimum score is 0 and maximum score is 30. Scores between 15 and 25 are considered within the normal range, while scores below 15 indicates poor self-esteem. An increase in RSES score over 6 months indicates a better outcome, or improved self-esteem, among participants.|Baseline and 6 months|5 out of the initial 43 participants dropped out of the study voluntarily|||scores on a scale||Standard Deviation|Mean
2549962|NCT02846558|Secondary|Sleep Quality|"The Pittsburgh Sleep Quality Index (PSQI) is an instrument used to measure the quality and sleeping pattern of adults. It differentiates poor from good sleep quality, and the total score is calculated from the sum of seven components, each scored from 0 to 3. The minimum total score is 0 and the maximum total score is 21. A total score equal to or greater than 5 units indicates poor quality sleep, while a score of 0-4 indicates good quality sleep; lower scores indicate better sleep quality. Decrease in PSQI score indicates a better outcome, or improved sleep quality, among study participants."|Baseline and 6 months|5 out of the initial 43 participants dropped out of the study voluntarily|||scores on a scale||Standard Deviation|Mean
2549963|NCT02846558|Secondary|Fatigue|The Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue is a question bank of 95 items validated to evaluated fatigue in a variety of chronic conditions. The PROMIS-FatigueMS is a subset of 8 questions from the question bank, which have been validated to measure fatigue in people with multiple sclerosis. Individual items are scored on a 5-point Likert scale, and the total score is the sum of individual items, with a minimum score of 8 and maximum score of 40. Lower scores indicate less fatigue, while higher scores indicate more fatigue. Reduction in score over 6 months indicates a better outcome, or improved fatigue among participants.|Baseline and 6 months|Discrepancy in numbers is due to non-completers|||scores on a scale||Standard Deviation|Mean
2549964|NCT02846558|Secondary|Functional Assessment in MS Score|The Functional Assessment in Multiple Sclerosis (FAMS) is an instrument that measures quality of life among people with MS. The instrument contains 44 questions scored on a 5-point Likert scale in 6 areas: mobility, symptoms, emotional wellbeing, general contentment, thanking/fatigue, and family/social wellbeing. Subscores for each area is calculated as the sum of responses in that section, and the total FAMS score is the sum of all subscores. Minimum total score is 0 and maximum total score is 176, where a higher score indicates better quality of life. Increase in the FAMS score over the study period indicates a better outcome, or improved quality of life, among participants.|Baseline and 6 months|5 out of the initial 43 participants dropped out of the study voluntarily|||scores on a scale||Standard Deviation|Mean
2549965|NCT02846558|Secondary|Weight Change Among Adherent Participants|The change in weight over 6 months among participants were remained adherence to the calorie restriction diet versus those who admitted to non-compliance by the end of the study period.|Baseline and 6 months|Discrepancy in numbers is due to non-completers. 5 out of the initial 43 participants dropped out of the study voluntarily|||kg||Standard Deviation|Mean
2549966|NCT02846558|Secondary|Weight Change|Change in participant weight over the 6-month study period|Baseline and 6 months|5 out of the initial 43 participants dropped out of the study voluntarily|||KG||Standard Deviation|Mean
2549967|NCT02846558|Secondary|Body Mass Index (BMI)|Change in body mass index from baseline to 6 months.|Baseline and 6 months|5 out of the initial 43 participants dropped out of the study voluntarily|||kg/m^2||Standard Deviation|Mean
2549968|NCT02846558|Primary|Adherence|Number of participants adhering to the prescribed dietary intervention at the end of the 6-month study period.|Baseline and 6 months||||Participants|||Count of Participants
2549969|NCT02845700|Secondary|Change in the Beck Anxiety Inventory-II From Baseline to 1 Month|The Beck Anxiety Inventory-II (BAI) was administered at the baseline appointment and 1-month follow-up appointment to assess symptom severity associated with anxious arousal. The BAI comprises 21 items rated on a 0-3 scale, which can be sum scored to calculate total scores ranging from 0 - 63. Higher scores on the BAI are indicative of greater anxious arousal. A difference scores was calculated by subtracting the BAI score at 1 month from BAI scores at baseline; thus, higher (positive) change scores are indicative of increases in anxious arousal, whereas lower (negative) change scores are indicative of decreases in anxious arousal.|Baseline, month 1||||Scores on the BAI||Standard Deviation|Mean
2549970|NCT02845700|Secondary|Change in Beck Suicide Scale Scores From Baseline to 1 Month|The Beck Suicide Scale (BSS) was administered at the baseline appointment and 1-month follow-up appointment to assess thoughts and behaviors related to suicidal ideation, desire, and attempts. The BSS comprises 21 items rated on a 0-3 scale. The first 19 items are sum scored with total possible scores ranging from 0 - 38, with higher scores indicating greater severity of suicide risk. A difference scores was calculated by subtracting the BSS score at 1 month from BSS scores at baseline. Mean change scores of 0 reflect no change in BSS scores from baseline to 1 month.|Baseline, month 1||||Scores on the BSS||Standard Deviation|Mean
2549971|NCT02845700|Secondary|Change in Suicidal Ideation Assessed Using the Depressive Symptom Inventory - Suicidality Subscale|The Depressive Symptom Inventory - Suicidality Subscale (DSI-SS) was administered at the baseline appointment and 1 month follow-up appointment to assess the severity of thoughts related suicidal ideation. All four items of the DSI-SS are scored on a 0-3 scale, with total possible sum scores ranging from 0-12; higher scores indicate greater severity of suicidal ideation. For the outcome measure reported, a difference score was calculated by subtracting DSI-SS scores at 1 month from DSI-SS scores at baseline, and averaged across conditions. DSI-SS change scores of zero reflect no change from baseline to 1 month.|Baseline, month 1||||Scores on the DSI-SS||Standard Deviation|Mean
2549972|NCT02845700|Secondary|Change From Baseline in Mean Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at 1 Month|The Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5) was administered at the baseline appointment and 1-month follow-up appointment to assess PTSD symptom severity. All 20 of the CAPS-5 items are scored 0-4 and summed to calculate a total score, which ranges from 0-80. Higher scores indicate greater PTSD symptom severity. A difference score was calculated by subtracting the CAPS-5 score at 1-month from baseline, and averaged across each condition; thus, higher (positive) change scores are indicative of increases in PTSD symptom severity, whereas lower (negative) change scores are indicative of decreases in PTSD symptom severity.|Baseline, month 1||||Score on the CAPS-5||Standard Deviation|Mean
2549973|NCT02845700|Primary|Percent Change in Olfactory Perceptual Bias|A participant's ability to detect an array of threatening malodor in neutral dilution gradients will be tested at baseline and after the second and final intervention session (one week after baseline). Perceptual bias is calculated as the percentage of correct responses (i.e., yes or no to detecting the malodor) on an odor over 6 trials for each of the 8 odors, at 25% and 33% dilution (i.e., over 96 trials). Larger positive percentages indicate greater habituation to the malodor, and therefore a training effect toward reducing threat bias (i.e., a positive effect on intervention outcomes).|Baseline, Week 1||||Percent of correctly identified odors||Standard Deviation|Mean
2549974|NCT02845674|Primary|Adverse Events|Number of subjects reporting any AEs|40 weeks|Safety population: Group 1 and Group 2 consisted of subsets of subjects who received masked treatment with OTX-101 0.09% or with Vehicle, respectively, in OTX-101-2016-001. All subjects received open-label treatment with OTX-101 0.09% in OTX-101-2016-002.|||Count of participants|||Number
2549975|NCT02845375|Primary|Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response)|The ventilatory response to a decrease in oxygen saturaytion of 80%|0-10 minutes following reversal|The ventilation-saturation data were analyzed using linear regreassion analysis. The slope is the acute hypoxic ventilatory response.|||L/min/%||Standard Deviation|Mean
2549976|NCT02845375|Primary|Breathing Increase Due to a Reduction in Inspired Oxygen Saturation (Hypoxic Ventilatory Response)|The change in breathing response to a decrease in inspired oxygen concentration, which equals the isocapnic ventilatory response to hypoxia.|during the 1-2 hours following reversal|Healthy male volunteers|||L/min/% desaturation||Standard Deviation|Mean
2549977|NCT02844998|Primary|Intravaginal Ejaculatory Latency Time|Duration determined by the sexual partner with stopwatch method, and <1 minute was considered as PE. (minimum/maximum scores were not possible)|Baseline and 30 Days||||seconds||Standard Deviation|Mean
2549979|NCT02844946|Secondary|Acceptance and Action Questionnaire-II (AAQ-II)|"The AAQ-II is an ACT-specific self-report measure of psychological inflexibility. Seven items are rated on a 7-point scale, ranging from 1 (never true) to 7 (always true), with higher scores reflecting greater inflexibility. Scores range from 1-49. Example items include, Emotions cause problems in my life, and My painful memories prevent me from having a fulfilling life. It has been shown to have good internal consistency and validity and also to mediate behavioral outcomes in ACT interventions."|Through study completion, an average of 3 months following workshop attendance|27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop.|||units on a scale||Standard Error|Mean
2549980|NCT02844946|Secondary|PTSD Checklist-Civilian Version (PCL-C)|PCL-C is a 17-item self-report questionnaire assessing the presence and severity of DSM-IV symptoms of PTSD during the past month. All items are added for a total severity score. Higher scores represent greater severity of PTSD symptoms. Scores range from 1-85.|Through study completion, an average of 3 months following workshop attendance|27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop.|||units on a scale||Standard Error|Mean
2549981|NCT02844946|Secondary|Military to Civilian Questionnaire (M2C-Q)|This 16-item self-report measure assesses post-deployment difficulties with reintegration during the previous month. Respondents rate the level of difficulty on a 5-point scale from No Difficulty to Extreme Difficulty (0-4). The following domains are covered by the M2C-Q: Social relations, community engagement, perceived meaning in life, self-care and leisure, and parenting. The total score is the average of the 16 items. Higher scores reflecting greater difficulty with reintegration.|Through study completion, an average of 3 months following workshop attendance|27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop.|||units on a scale||Standard Error|Mean
2549982|NCT02844946|Primary|World Health Organization Disability Assessment Schedule II (WHODAS-II)|Assesses functioning and disability due to health conditions. Six domains are covered: understanding and communicating, getting around, self-care, getting along with people, life act. This is a self-report measure that assesses behavioral and functional impairments as a separate domain from disease symptoms. Higher scores indicate higher disability (from 0-100).|Through study completion, an average of 3 months following workshop attendance|27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop.|||units on a scale||Standard Error|Mean
2549983|NCT02844946|Primary|Brief Pain Inventory (BPI)|"Assesses the severity of pain and the impact of pain on daily functions. The BPI severity scale assesses pain at its worst, least, average, and now (current pain). A composite of the four pain items (a mean severity score) is used here as recommended for assessing pain in clinical trials. Higher scores represent greater severity (0-10)."|Through study completion, an average of 3 months following workshop attendance|27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop.|||units on a scale||Standard Deviation|Mean
2549984|NCT02844946|Primary|Depression Anxiety and Stress Scale (DASS-21)|Consists of three self-report scales that measure current depression, anxiety, and stress. This 21-item measure consists of three self-report scales that measure current symptoms of depression, anxiety, and stress and a total score. It has been used extensively in clinical trials, including those with military populations. Higher scores represent greater distress and scores range from 0-126.|Through study completion, an average of 3 months following workshop attendance|27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop.|||units on a scale||Standard Error|Mean
2549985|NCT02844946|Primary|World Health Organization-Quality of Life (WHO-QOL)|Quality of Life. The general Quality of Life scale includes 2 items that measure overall QOL and general health. Items scored are scored from 1-5 so the range for the this scale is 2-10 with higher scores representing higher quality of life.|Through study completion, an average of 3 months following workshop attendance|27 participants were assigned to the ACT on Life Condition. Only 19 were eligible, with valid data, and actually began the workshop.|||units on a scale||Standard Error|Mean
2549986|NCT02844920|Secondary|Umber of Participants With Absence of Newly Formed Adhesions Following RF Ablation of Fibroids in Participants With Apposing Fibroids Treated|As the risk of adhesion formation is higher when apposing fibroids are treated, this outcome measure assesses adhesiogenesis in the subgroup of the population who completed the follow-up assessment, had evaluable hysteroscopy videos, and had apposing fibroids treated.|6 weeks|Participants who completed the follow-up assessment, had evaluable hysteroscopy videos, and had apposing fibroids treated.|||Participants|||Count of Participants
2549987|NCT02844920|Primary|Number of Participants With Absence of Newly Formed Intrauterine Adhesions Following RF Ablation of Fibroids|Hysteroscopic evaluation by independent readers to determine the presence or absence of adhesions following transcervical RF ablation of fibroids with the Sonata system in participants who completed the follow-up assessment AND evaluable hysteroscopy videos.|6 weeks|Participants with completed follow-up assessment and had evaluable hysteroscopy videos.|||Participants|||Count of Participants
2549988|NCT02844569|Primary|Change in Buccal Bone Volume Between Baseline and 6 Months|The buccal bone volume change between baseline and 6 months will be calculated from cone-beam computed tomography data.|6 months||||mm^3||Standard Deviation|Mean
2549989|NCT02844569|Primary|Change in Buccal Soft Tissue Volume Between Baseline and 6 Months|The soft tissue volume change between baseline and 6 months based on 3D images captured with intra-oral digital scanner.|6 months||||mm^3||Standard Deviation|Mean
2549990|NCT02844569|Primary|Change in Buccal Plate Thickness From Baseline to Month 6|The thickness difference between baseline and 6 months will be measured by the difference in mm using cone-beam computed tomography.|6 months||||mm||Standard Deviation|Mean
2549991|NCT02844543|Primary|Changes in the Eye-tracking Score Before and After Practice or Game: Vertical and Horizontal Gain|"The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC.~Vertical and horizontal gain are defined as the ratio of velocity (velocity of the eye:velocity of the target). Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target."|Up to 6 hours|Participants with evaluable data at the respective time point were included in the analysis.|||Ratio of velocity (degrees per second)||Standard Deviation|Mean
2549992|NCT02844543|Primary|Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error|"The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC.~Tangential and radial error are defined as degrees of variation in eye tracking along a circular path (tangential) and at 90 degrees to the tangential path (radial). Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target."|Up to 6 hours|Participants with evaluable data at the respective time point were included in the analysis.|||Degrees of variation||Standard Deviation|Mean
2549993|NCT02844543|Secondary|Changes in Sport Concussion Assessment Tool (SCAT-3) Standardized Assessment of Concussion (SAC) Score|Change in SCAT-3 SAC score before and after practice or game is reported. The SAC score is based on the following assessments: number of symptoms (22 points), symptom severity (132 points), orientation (5 points), immediate memory (15 points), concentration (5 points), and delayed recall (5 points). Scores are summed for a possible range of 0 to 184, with lower scores corresponding to fewer concussion symptoms, and higher scores corresponding to more concussion symptoms.|Day of study/event (up to 6 hours)|Participants who completed the protocol were included in the analysis.|||units on a scale||Standard Deviation|Mean
2549994|NCT02844543|Primary|Changes in the Eye-tracking Score Before and After Practice or Game: Phase Error|"The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC.~Phase error is defined as the difference in degrees between movement of the target and the movement of the eye. Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target."|Up to 6 hours|Participants with evaluable data at the respective time point were included in the analysis.|||Degrees||Standard Deviation|Mean
2549995|NCT02843659|Secondary|Mean Change From Baseline in Work Participation and Activity Impairment Questionnaire (WPAI)|Affords calculation of 4 scales to measure the impact of IBD on different domains of impairment in work or other activities: absenteeism, presenteeism (impairment at work), productivity loss (overall work impairment), activity impairment|At baseline, week 4, week 8, week 12, and week 18|The study was terminated and data is not reported for privacy reasons||||||
2549996|NCT02843659|Secondary|Mean Change From Baseline in Female Sexual Function Index (FSFI)|The Female Sexual Function Index (FSFI), a 19-item questionnaire, has been developed as a brief, multidimensional self-report instrument for assessing the key dimensions of sexual function in women|At baseline, week 4, week 8, week 12, and week 18|The study was terminated and data is not reported for privacy reasons||||||
2549997|NCT02843659|Secondary|Mean Change From Baseline in Short Form-36 (SF-36)|First, precoded numeric values are recoded per the scoring key given in Table 1. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Table 2 lists the items averaged together to create each scale. Items that are left blank(missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered|At baseline, week 4, week 8, week 12, and week 18|The study was terminated and data is not reported for privacy reasons||||||
2549998|NCT02843659|Secondary|Mean Change Form Baseline in Physician Global Assessment of Disease Activity (phyGDA)|The investigator's or physician's overall assessment of disease activity from 0-10 cm VAS scale with 0 being no disease and 10 cm being most severe disease.|At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18|The study was terminated and data is not reported for privacy reasons||||||
2549999|NCT02843659|Secondary|Mean Change From Baseline in Subject Global Assessment of Disease Activity (SubGDA)|The subjects overall assessment of disease activity from 0-10 cm VAS scale with 0 being no disease and 10 cm being most severe disease|At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18|The study was terminated and data is not reported for privacy reasons||||||
2550000|NCT02843659|Secondary|Mean Change From Baseline in Numeric Rating Scale (NRS) for Mouth, Eye and Vaginal Dryness|The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. 0 = No Pain, 1-3 = Mild Pain(nagging, annoying, interfering little with ADLs), 4-6 = Moderate Pain (interferes significantly with ADLs), 7-10 = Severe Pain (disabling; unable to perform ADLs)|At baseline, at week 2, week 4, week 6, week 8, week 10, week 12, and week 18|The study was terminated and data is not reported for privacy reasons||||||
2550001|NCT02843659|Secondary|Mean Change From Baseline in the Tear Break-up Time Test|Determined by instilling fluorescein dye and evaluating the stability of the pre-corneal tear film. After several blinks, the tear film is examined using a broad beam of the slit-lamp (biomicroscope) with a cobalt blue filter. The TBUT, defined as the time in seconds between the subjects's last blink and the first appearance of a random dry spot on the corneal surface, is measured 3 times and the mean value is recorded.|At baseline, week 4, week 8, and week 12|The study was terminated and data is not reported for privacy reasons||||||
2550002|NCT02843659|Secondary|Mean Change From Baseline in Schrimer's Test|The test (without anaesthesia) was performed by placing a narrow calibrated filter-paper strip in the inferior cul-de-sac of each eye. Aqueous tear production was measured by the length in millimeters that the strip wets during the 5 minute test period|At baseline, week 4, week 8, and week 12|The study was terminated and data is not reported for privacy reasons||||||
2550003|NCT02843659|Secondary|Mean Change From Baseline in Ocular Surface Staining|The test was performed by instillation of fluorescein dye and either lissamine green or Rose bengal dye to stain the cornea and conjunctiva, respectively. After instilling the dye, the ocular surface was examined through a slit lamp (biomicroscope).|At baseline, week 4, week 8, and week 12|The study was terminated and data is not reported for privacy reasons||||||
2550004|NCT02843659|Secondary|Mean Change From Baseline in Stimulated Salivary Flow Rate|Serum and saliva biomarkers (collected from samples obtained during unstimulated and stimulated salivary flow assessments) were measured to determine the potential PD effect of BMS-931699 and BMS-986142 on disease-related protein analytes. These assessments included, but were not limited to, the detection of cytokines and other protein analytes by immunoassays and/or mass spectrometry proteomic profiling.|At baseline, week 4, week 8, and week 12|The study was terminated and data is not reported for privacy reasons||||||
2550005|NCT02843659|Secondary|Mean Change From Baseline in Unstimulated Salivary Flow Rate|Serum and saliva biomarkers (collected from samples obtained during unstimulated and stimulated salivary flow assessments) were measured to determine the potential PD effect of BMS-931699 and BMS-986142 on disease-related protein analytes. These assessments included, but were not limited to, the detection of cytokines and other protein analytes by immunoassays and/or mass spectrometry proteomic profiling.|At baseline, week 4, week 8, and week 12|The study was terminated and data is not reported for privacy reasons||||||
2550006|NCT02843659|Secondary|Mean Change in Baseline in ESSPRI Individual Component of Pain|ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains|At baseline, week 4, week 8, and week 12|The study was terminated and data is not reported for privacy reasons||||||
2550007|NCT02843659|Secondary|Mean Change in Baseline in ESSPRI Individual Component of Fatigue|ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains|At baseline, week 4, week 8, and week 12|The study was terminated and data is not reported for privacy reasons||||||
2550008|NCT02843659|Secondary|Mean Change in Baseline in ESSPRI Individual Component of Dryness|ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains|At baseline, week 4, week 8, and week 12|The study was terminated and data is not reported for privacy reasons||||||
2550009|NCT02843659|Secondary|Proportions of Subjects With >=1 Point of Improvement From Baseline in ESSPRI|ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains|At week 12|The study was terminated and data is not reported for privacy reasons||||||
2550010|NCT02843659|Secondary|Proportion of Subjects With Both >= 3 Points Improvement in ESSDAI and >= 1 Point Improvement in ESSPRI From Baseline at Week 12|The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening|At week 12|The study was terminated and data is not reported for privacy reasons||||||
2550011|NCT02843659|Secondary|Proportion of Subjects With a > = 3 Point Improvement From Baseline in ESSDAI at Week 12|The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening|At week 12|The study was terminated and data is not reported for privacy reasons||||||
2550012|NCT02843659|Secondary|Mean Change From Baseline in ESSPRI Score at Week 4, Week 8, and Week 12.|ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains.|At baseline, week 4, week 8, and week 12|The study was terminated and data is not reported for privacy reasons||||||
2550013|NCT02843659|Secondary|Mean Change From Baseline in ESSDAI Scores at Week 4 and Week 8|The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening|At baseline, week 4 and week 8|The study was terminated and data is not reported for privacy reasons||||||
2550014|NCT02843659|Primary|Mean Change From Baseline in ESSDAI|The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening|At baseline and week 12|The study was terminated and data is not reported for privacy reasons||||||
2550015|NCT02843178|Other Pre-specified|Self-reported Weight Survey|Self-reported weight by phone survey.|Month 6||||pounds||95% Confidence Interval|Mean
2550061|NCT02842086|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 in the Blinded Phase|Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.|Baseline, Week 48|Hip DXA Analysis Set included all DXA substudy participants who were randomized and received at least one dose of study drug, and had nonmissing hip BMD value for the baseline visit. Participants were grouped according to the treatment they actually received. Participants with available data were analyzed.|||Percent Change||Standard Deviation|Mean
2550016|NCT02843178|Other Pre-specified|Food Security Survey|"This is the 6-item United States Department of Agriculture food security scale; the survey questions are in the appendix under Main Survey. Each of the responses to the 6 questions were scored as a 1 or 0, depending of the particular question. The individual scores were then totaled, and individuals could receive a score anywhere from 0 indicating the most food security to 6 indicating the least food security. Then, the totaled individual 0 to 6 scores (fs_total) were broken into two categories, 0-1 being food secure, and 2-6 being food insecure. The number of participants below reflects the total number of participants who were food secure (that is, scored fs_total = 0-1) at Baseline, Month 6, and Month 12, respectively."|Baseline, Month 6, and Month 12||||Participants|||Count of Participants
2550017|NCT02843178|Other Pre-specified|Self-reported Height Survey|Self-reported height by phone survey.|Month 6||||inches||95% Confidence Interval|Mean
2550018|NCT02843178|Other Pre-specified|Voucher Ease of Use Survey|Survey of how easy participants found it to use vouchers. This is a composite score ranging from 0 (hard) to 3 (easy) based on individual scores of 0 (hard) or 1 (easy) in response to three questions at month 6 (the questions are in the appendix), which assessed participants' understanding of how to use the vouchers, ability to determine which foods were redeemable, and ease of redeeming the voucher with a cashier.|Month 6||||score on a scale||95% Confidence Interval|Mean
2550019|NCT02843178|Secondary|Voucher Utilization Rate|Percent of vouchers utilized by participants in each study arm|Months 1-6 of intervention||||Percent of vouchers utilized||95% Confidence Interval|Number
2550020|NCT02843178|Secondary|Change in Healthy Eating Index From Baseline to Month 6|Healthy Eating Index (a composite metric of nutrition quality) estimated from 24-hour dietary recall. The scores range from 0 to 100. An ideal overall Healthy Eating Index score of 100 reflects that the set of foods aligns with key dietary recommendations from the Dietary Guidelines for Americans (DGA).|Baseline and Month 6||||change in Index from mo 0 to mo 6||95% Confidence Interval|Mean
2550021|NCT02843178|Secondary|Change in Cup-equivalents of Fruit and Vegetable Intake From Baseline to Month 12|Fruit and vegetable intake (measured in Cup-equivalents) at the end of month 12 of the trial (6 months after voucher program has ended), assessed by 24-hour dietary recall.|Baseline and Month 12||||Change in Cup-equivalents, mo 0 to mo 12||95% Confidence Interval|Mean
2550022|NCT02843178|Primary|Change in Cup-equivalents of Fruit and Vegetable Intake From Baseline to Month 6|Fruit and vegetable intake (measured in Cup-equivalents) at the end of month 6 of the trial, assessed by 24-hour dietary recall|Baseline and Month 6||||Change in Cup-equivalents, mo 0 to mo 6||95% Confidence Interval|Mean
2550023|NCT02842866|Secondary|Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine|GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA method.|Day 30 (Post-vaccination)|Analysis was performed on per-protocol analysis set.|||titers (1/dilutions)||95% Confidence Interval|Geometric Mean
2550024|NCT02842866|Primary|Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menomune® Vaccine|Vaccine seroresponse for serogroups A, C, Y, and W was measured by serum bactericidal assay using human complement (hSBA). It was defined as post-vaccination hSBA titers ≥1:16 for participants with pre-vaccination hSBA titers less than (<) 1:8, or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers ≥1:8.|Day 30 (Post-vaccination)|Analysis was performed on per protocol analysis set which included all participants who received at least one dose of the study vaccine, had a valid post-vaccination serology result and had no protocol deviations.|||percentage of participants||95% Confidence Interval|Number
2550025|NCT02842853|Secondary|Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra®|Antibody titers of meningococcal serogroups A, C, Y, and W were measured by hSBA.|Day 30 (post-vaccination)|Analysis performed on PPAS. Here, “Overall number of participants analyzed” = participants evaluable for this outcome measure; and “Number analyzed”= number of participants with available data for specified category. Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine reporting groups.|||Titer (1/dilution)||95% Confidence Interval|Geometric Mean
2550026|NCT02842853|Secondary|Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine|Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers >= 1:16 for participants with pre-vaccination hSBA titers < 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers >= 1:8.|Day 30 (post-vaccination)|"Analysis was performed on PPAS. Here, Number analyzed = participants with available data for specified category. Data for this outcome measure were not planned to be collected and analyzed for the Menactra® reporting group."|||percentage of participants||95% Confidence Interval|Number
2550027|NCT02842853|Secondary|Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adolescents|Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers >= 1:16 for participants with pre-vaccination hSBA titers < 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers >= 1:8. Only adolescents aged 10-17 years who received a single dose of Menactra® (Group 4a) or MenACYW Conjugate vaccine (Group 1a-3a) from any of the lots 1, 2 or 3, were included in this outcome measure.|Day 30 (post-vaccination)|Analysis performed on PPAS. Here, “Overall number of participants analyzed” = participants evaluable for this outcome measure; and “Number analyzed” = participants with available data for specified category. Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine reporting groups.|||percentage of participants||95% Confidence Interval|Number
2550077|NCT02841709|Primary|Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2|WASO is the time in minutes spent awake after onset of persistent sleep until lights on as determined by polysomnography (PSG)|Baseline to Day 1 and Day 2 of each treatment period||||minutes||Standard Error|Least Squares Mean
2550028|NCT02842853|Secondary|Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adults|Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers >= 1:16 for participants with pre-vaccination hSBA titers < 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers >= 1:8. Only adults aged 18-55 years who received a single dose of Menactra® (Group 4b) or MenACYW Conjugate vaccine (Group 1b-3b) from any of the lots 1, 2 or 3, were included in this outcome measure.|Day 30 (post-vaccination)|"Analysis was performed on PPAS. Here, “Overall number of participants analyzed” = participants evaluable for this outcome measure; and Number analyzed”= participants with available data for specified category. Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine reporting groups."|||percentage of participants||95% Confidence Interval|Number
2550029|NCT02842853|Primary|Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine|Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers >= 1:16 for participants with pre-vaccination hSBA titers < 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers >= 1:8.|Day 30 (post-vaccination)|"Analysis was performed on PPAS. Here, Number analyzed=participants with available data for specified category. Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine reporting groups."|||percentage of participants||95% Confidence Interval|Number
2550030|NCT02842853|Primary|Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine|Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Data for this outcome measure were not planned to be collected and analyzed for the Menactra® reporting group.|Day 30 (post-vaccination)|"Per-Protocol Analysis Set (PPAS) defined for accessing ACYW immune response data for participants who received at least one dose of study vaccine & had a valid post-vaccination serology result. Participants who presented pre-defined protocol deviations were excluded. Here, Number analyzed = participants with available data for specified category."|||Titer (1/dilution)||95% Confidence Interval|Geometric Mean
2550031|NCT02842736|Primary|Primary Effectiveness Endpoint: Number of Subjects With Reduction in Menstrual Bleeding to PBLAC Score of ≤75|"Success for the primary effectiveness endpoint was defined as reduction in menstrual bleeding to a PBLAC (Pictorial Blood Loss Assessment Chart) score of ≤75.~Scale information for PBLAC (Pictorial Blood Loss Assessment Chart):~The scale minimum is 0, which indicates amenorrhea, i.e. no bleeding. There is no scale maximum. A score of 100 indicates eumenorrhea, i.e. normal menstrual bleeding. A lower PBLAC score indicates less bleeding; a higher PBLAC score indicates more bleeding."|12 months|The Intent-to-Treat (ITT) population comprised all patients who successfully completed screening and presented on the day of treatment.|||Participants|||Count of Participants
2550032|NCT02842736|Primary|Primary Safety Endpoint: Number of Serious Adverse Events and Serious Device-related Adverse Events||12 months|The Intent-to-Treat (ITT) population is comprised of all patients who successfully completed screening and presented on the day of treatment.|||Reports of events|||Number
2550033|NCT02842242|Other Pre-specified|Number of Subjects Achieving an LVOT Gradient Response of Post-exercise Peak Gradient < 10 mmHg at Week 12|Post-exercise peak LVOT gradients are assessed after a treadmill stress test by echocardiography.|Baseline and Week 12|||||||
2550034|NCT02842242|Other Pre-specified|Change in NT-proBNP From Baseline to Week 12||12 weeks|||||||
2550035|NCT02842242|Other Pre-specified|Change in KCCQ OSS From Baseline to Week 12||Baseline and Week 12|||||||
2550036|NCT02842242|Other Pre-specified|Change in NYHA Functional Class From Baseline to Week 12||Baseline and Week 12|||||||
2550037|NCT02842242|Secondary|Change in Post-exercise Peak LVOT Gradient From Week 12 to Week 16|Post-exercise peak LVOT gradients are assessed after a treadmill stress test by echocardiography.|Weeks 12 and 16||||mm Hg||Standard Deviation|Mean
2550038|NCT02842242|Secondary|Change in Global Longitudinal Strain (GLS) From Baseline to Week 12|GLS is assessed using echocardiography measures.|Baseline and Week 12||||Percent||Standard Deviation|Mean
2550039|NCT02842242|Secondary|Change in LV Fractional Shortening (LVFS) From Baseline to Week 12|LVFS is assessed using echocardiography measures.|Baseline and Week 12||||Percent||Standard Deviation|Mean
2550040|NCT02842242|Secondary|Change in Resting LVEF From Baseline to Week 12|LVEF is assessed by echocardiography.|Baseline and Week 12||||Percent change||95% Confidence Interval|Mean
2550041|NCT02842242|Secondary|Change in VE/VCO2 From Baseline to Week 12|VE/VCO2 is assessed from cardiopulmonary exercise testing results.|Baseline and Week 12||||Ratio||95% Confidence Interval|Mean
2550042|NCT02842242|Secondary|Change in Peak VO2 From Baseline to Week 12|Peak VO2 is assessed using a cardiopulmonary exercise test.|Baseline and Week 12||||mL/kg/min||95% Confidence Interval|Mean
2550043|NCT02842242|Secondary|Change in Dyspnea Symptom Score From Baseline to Week 12|The scale name is Dyspnea Numeric Rating Scale (NRS). It is intended to measure how much shortness of breath you have had in the past week. 0 = no shortness of breath and 10 = shortness of breath as the worst possible.|Baseline and Week 12||||units on a scale||95% Confidence Interval|Mean
2550044|NCT02842242|Secondary|Number of Participants Achieving a Post-exercise Peak LVOT Gradient Response of < 30 mmHg. Gradient < 30 mmHg|LVOT gradients are assessed after a treadmill stress test by echocardiography.|Baseline and Week 12||||Participants|||Count of Participants
2550045|NCT02842242|Primary|Change in Post-exercise Peak LVOT Gradient From Baseline to Week 12|Post-exercise peak LVOT gradients are assessed after a treadmill stress test by echocardiography.|Baseline and Week 12||||mm Hg||95% Confidence Interval|Mean
2550121|NCT02839902|Secondary|Percent Changes From Baseline in Eicosapentaenoic Acid Plus Docosahexaenoic Acid to Arachidonic Acid (EPA+DHA/AA) Ratio in Total Lipids|The reported data are percent of change from baseline in EPA+DHA/AA ratio in total lipids at Week 4 and Week 8.|Baseline, Week 4 and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||Percent of Change||Standard Deviation|Mean
2550046|NCT02842151|Primary|IOL A-constant at 3 Months at Each Site|The A-constant, is a type of IOL constant, that accounts for clinical variables that may affect the refractive outcome (e.g. patient factors, biometry method). It relates the power of the IOL to axial length and corneal measurements. It is specific to the design of the IOL, style, and placement within the eye. The optimization of the A-constant is fundamental to achieving the targeted refractive outcomes, offset any observed error and for ensuring high patient satisfaction following cataract surgery. Since errors/noise from refraction plays a significant role in A-constant optimization, it is important to determine if an automated method has any advantages over conventional manifest refraction. A-constants based on autorefraction and manifest refraction for the study eye are compared for each subject. The mean difference between the two methods cannot be greater than 0.15 D at each of the three study centers for the methods to be considered equivalent.|Month 3 (Day 80-100) Post Study Eye Implantation|All-Implanted Analysis Set with non-missing data|||unitless|Eyes|Standard Deviation|Mean
2550047|NCT02842086|Secondary|Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality||First dose date up to the data cut for primary endpoint assessment plus 30 days (maximum: 125 weeks + 30 days)|Participants in Safety Analysis Set with available data were analyzed.|||percentage of participants|||Number
2550048|NCT02842086|Secondary|Percentage of Participants Experiencing Treatment-Emergent Adverse Events||First dose date up to the data cut for primary endpoint assessment plus 30 days (maximum: 125 weeks + 30 days)|Participants in Safety Analysis Set were analyzed.|||percentage of participants|||Number
2550049|NCT02842086|Secondary|Change From Baseline in Serum Creatinine at Week 96 in the Blinded Phase||Baseline, Week 96|Participants in Safety Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
2550050|NCT02842086|Secondary|Number of Participants by UP and UPCR Categories at Week 96 in the Blinded Phase|"The UPCR was only calculated when corresponding UP ≥ 4.0 mg/dL. The UPCR ≤ 200 mg/g category includes both participants with UP < 4.0 mg/dL and participants with UPCR ≤ 200 mg/g."|Baseline, Week 96|Participants in Safety Analysis Set with available data were analyzed.|||Participants|||Count of Participants
2550051|NCT02842086|Secondary|Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96 in the Blinded Phase|"Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.~For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios."|Baseline, Week 96|Participants in Safety Analysis Set with available data were analyzed.|||Percent Change||Inter-Quartile Range|Median
2550052|NCT02842086|Secondary|Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 96 in the Blinded Phase|"Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.~For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios."|Baseline, Week 96|Participants in Safety Analysis Set with available data were analyzed.|||Percent Change||Inter-Quartile Range|Median
2550053|NCT02842086|Secondary|Percent Change From Baseline in Spine BMD at Week 96 in the Blinded Phase|Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.|Baseline, Week 96|Participants in Spine DXA Analysis Set with available data were analyzed.|||Percent Change||Standard Deviation|Mean
2550054|NCT02842086|Secondary|Percent Change From Baseline in Hip BMD at Week 96 in the Blinded Phase|Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.|Baseline, Week 96|Participants in Hip DXA Analysis Set with available data were analyzed.|||Percent Change||Standard Deviation|Mean
2550055|NCT02842086|Secondary|Incidence of HIV-1 Infection Per 100 PY|"The incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study.~HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab:~Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or~Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or~Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results)"|When all participants have 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 31 months)|||||||
2550056|NCT02842086|Secondary|Change From Baseline in Serum Creatinine at Week 48 in the Blinded Phase||Baseline, Week 48|Participants in Safety Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
2550057|NCT02842086|Secondary|Number of Participants by Urine Protein (UP) and Urine Protein to Creatinine Ratio (UPCR) Categories at Week 48 in the Blinded Phase|"The UPCR was only calculated when corresponding UP ≥ 4.0 mg/dL. The UPCR ≤ 200 mg/g category includes both participants with UP < 4.0 mg/dL and participants with UPCR ≤ 200 mg/g."|Baseline, Week 48|Participants in Safety Analysis Set with available data were analyzed.|||Participants|||Count of Participants
2550058|NCT02842086|Secondary|Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 in the Blinded Phase|"Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.~For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios."|Baseline, Week 48|Participants in Safety Analysis Set with available data were analyzed.|||Percent Change||Inter-Quartile Range|Median
2550059|NCT02842086|Secondary|Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 48 in the Blinded Phase|"Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.~For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios."|Baseline, Week 48|The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. Participants were grouped according to the treatment they actually received. Participants with available data were analyzed.|||Percent Change||Inter-Quartile Range|Median
2550060|NCT02842086|Secondary|Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase|Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.|Baseline, Week 48|Spine DXA Analysis Set included all DXA substudy participants who were randomized and received at least one dose of study drug, and had nonmissing spine BMD value for the baseline visit. Participants were grouped according to the treatment they actually received. Participants with available data were analyzed.|||Percent Change||Standard Deviation|Mean
2550062|NCT02842086|Primary|Incidence of HIV-1 Infection Per 100 Person Years (PY)|"The incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study.~HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab:~Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or~Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or~Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results)"|When all participants completed minimum follow-up of 48 weeks and at least 50% of the participants completed 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 29 months)|The Full Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, were not HIV positive on Day 1, and had at least 1 postbaseline HIV laboratory assessment.|||HIV-1 infections per 100 PY||95% Confidence Interval|Number
2550063|NCT02842073|Secondary|Mean Number of Drinks/Binge Drinking Day During Treatment||12 weeks||||drinks/binge drinking day||Standard Deviation|Mean
2550064|NCT02842073|Secondary|Final Penn Alcohol Craving Scale (PACS) Score|Craving for alcohol will be assessed using the Penn Alcohol Craving Scale (PACS) The PACS is a five-item self-administered instrument for assessing craving. Frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking. The final item asks the responder to provide an average rating of his/her craving over the course of the past week. The questions on the PACS use descriptors coupled with numerical ratings ranging from 0 to 6 with the highest possible total score of 30. Higher scores reflect a higher level of craving. This outcome measure is the final PACS total score obtained in the trial.|12 weeks||||units on a scale||Standard Deviation|Mean
2550065|NCT02842073|Primary|Number of Binge Drinking Days During Treatment|The number of binge drinking days during treatment with bupropion + naltrexone|12 weeks||||days||Standard Deviation|Mean
2550066|NCT02842073|Primary|Number of Participants Discontinuing Subsequent to Defined Intolerance|Retention was evaluated indirectly by accounting for those participants who discontinued either naltrexone or bupropion or study participation itself due to intolerance.|Throughout study, a total of approximately 12 weeks||||Participants|||Count of Participants
2550067|NCT02842073|Primary|Number of Participants With Treatment-Associated Adverse Events|Tolerability assessed by specifically probing for intervention-associated adverse effects.|12 weeks||||Participants|||Count of Participants
2550068|NCT02842060|Secondary|Changes in Psychological Well-being|The investigators will measure symptoms of depression and anxiety using the Brief Symptom Inventory by Derogatis & Spencer (1982). Higher mean scores (scale 1-4) indicate greater symptoms of psychological distress.|Baseline to 90-day follow-up period||||score on a scale||Standard Deviation|Mean
2550069|NCT02842060|Secondary|Change in Self-efficacy Motivations to Engage in HIV Prevention Behaviors|The investigators will measure the change in safer sex self-efficacy over time using the HIV Risk Behavior Self-Efficacy Scale by Fisher, Fisher, Misovich, Kimble & Malloy (1996). The scale is measured on a 4-point scale (range 1-4), where higher scores mean less self-efficacy to negotiate safer sex with partners met online.|Baseline to 90-day follow-up period||||score on a scale||Standard Deviation|Mean
2550070|NCT02842060|Primary|Number of Participants With Change in HIV Testing Behavior|The investigators estimated the number of participants who reported testing for HIV from baseline to 90-day follow-up.|Count of participants from baseline to 90-day follow-up reported||||Participants|||Count of Participants
2550071|NCT02842060|Primary|Number of Participants With Change in Number of Risky Sexual Partnerships|The investigators estimated the change in the total number of participants who reported engaging in condomless anal intercourse from baseline to 90-day follow-up.|Count of participants from baseline to 90-day follow-up reported||||Participants|||Count of Participants
2550072|NCT02841787|Primary|Average Coaching Time Per Participant by Group|The average time spent on messages and calls and on group moderation.|8 weeks|Participants were included in outcome analyses if they completed assessments at both baseline and week 8; for the Individual Internet Intervention (III) arm, 9 participants met this criterion, and for Internet Intervention with Peer Support (II+PS), 19 participants met this criterion.|||Minutes||Standard Deviation|Mean
2550073|NCT02841787|Primary|System Usability Scale (SUS)|The System Usability Scale (SUS) is a usability scale that can be used for global assessments of systems usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Originally created by John Brooke in 1986, it allows you to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. A SUS score above a 68 would be considered above average and anything below 68 is below average.|Week 8|Participants were included in outcome analyses if they completed assessments at both baseline and week 8; for the Individual Internet Intervention (III) arm, 9 participants met this criterion, and for Internet Intervention with Peer Support (II+PS), 21 participants met this criterion.|||units on a scale||Standard Deviation|Mean
2550074|NCT02841787|Primary|Mean Number of Sessions Across the 8-week Trial||8 weeks|Out of the 12 participants who started Individual Internet Intervention, one participant was administratively dropped (no longer eligible for the study) before treatment started; only 11 participants were analyzed.|||number of sessions||Standard Deviation|Mean
2550075|NCT02841787|Primary|Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module|"The PHQ-9 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-27. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-27 is severe.~The data table below shows PHQ-9 pre- and post- intervention score differences by group."|Baseline and Week 8 - Difference in PHQ-9 score||||units on a scale||Standard Deviation|Mean
2550076|NCT02841709|Secondary|Change in Mean Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2|LPS is the duration of time in minutes from lights off to persistent sleep onset as determined by PSG|Baseline to Day 1 and Day 2 of each treatment period||||Minutes||Standard Deviation|Mean
2550078|NCT02841241|Other Pre-specified|Number of Participants With Intolerance to Esmolol Infusion at Any Given Rate|"Patients who met a prespecified stop event for esmolol titration, suggesting intolerance to a given infusion rate.~Per protocol, study drug titration: The target heart rate is 85 bpm. Start study drug infusion at 20 mcg/kg/min, without bolus, if HR (heart rate) ≥ 100 bpm. If HR >90 bpm and <100 bpm, start study drug infusion at 10 mcg/kg/min, without bolus. Increase by 20 mcg/kg/min every 20 minutes as long as HR > 90 bpm, to a maximum dose of 100 mcg/kg/min. If HR < 80 bpm and > 70 bpm, decrease infusion rate by 10 mcg/kg/min; if HR ≤ 70 bpm and > 60 bpm, decrease infusion rate by 20 mcg/kg/min."|duration of esmolol infusion (~2 days)||||Participants|||Count of Participants
2550079|NCT02841241|Other Pre-specified|Percentage Hourly Checks During Which Protocol Compliance Was Observed|"For the esmolol titration protocol, each hour (the closest value of heart rate to the hour) during the esmolol infusion will be determined to be in range or out of range, with 3bpm margin for compliance (i.e., heart rate 77 to 93bpm). The initiation and cessation of esmolol will also be included as a timepoint for evaluation of compliance. Protocol compliance is considered adequate where overall compliance on hourly checks is >80%."|for duration of esmolol infusion, an expected average of 2 days||||Percentage of hourly checks||Standard Deviation|Mean
2550080|NCT02841241|Other Pre-specified|Proportion of Compliance With Final Safety Check||Day 0||||Participants|||Count of Participants
2550081|NCT02841241|Secondary|Development of Heart Block||for duration of esmolol infusion, an expected average of 2 days||||Participants|||Count of Participants
2550082|NCT02841241|Secondary|Left Ventricular Global Longitudinal Strain at 24 Hours||Day 1||||Percentage of myocardial shortening (%)||Inter-Quartile Range|Median
2550083|NCT02841241|Secondary|Peak Serum High-sensitivity Troponin|Measured after enrollment.|Troponin is measured on day 0 and day 1 (first day of esmolol infusion is day 0)||||ng/ml||Inter-Quartile Range|Median
2550084|NCT02841241|Secondary|All-cause Mortality||90 days||||Participants|||Count of Participants
2550085|NCT02841241|Primary|Organ-failure-free Days|"As of day 28, the number of calendar days on which the patient receives none of (a) vasopressor therapy, (b) mechanical ventilation, or (c) renal replacement therapy. If the patients dies on or before day 28, they have -1 organ-failure-free days.~The resulting point-based score combines the probability of death and the number of days without organ failure.~Score of -1 = Death before day 28 (Lowest Score). Score of 28 = Patient has been successful at going 28 without any vasopressor therapy/mechanical ventilation/renal replacement therapy (Highest Score)"|Day 28||||units on a scale||Inter-Quartile Range|Median
2550086|NCT02841046|Other Pre-specified|Complication After Surgery|From the end of surgery to the time of discharge from hospital.including ileus,abdominal infection,infection of incisional wound,pulmonary infection|up to 8 weeks|||||||
2550087|NCT02841046|Other Pre-specified|The Volume of Colloid Infusion|Volume of colloid infusion in milliliter.|during the surgery|||||||
2550088|NCT02841046|Other Pre-specified|The Volume of Crystalloid Infusion|Volume of crystalloid infusion in milliliter.|during the surgery|||||||
2550089|NCT02841046|Secondary|Number of Days in Hospital|The number of days from the admission to hospital until the discharge from hospital|up to 10 weeks|||||||
2550090|NCT02841046|Secondary|Oxygen Extraction Rate（ERO2）|oxygen extraction rate(ERO2) in percentage.Record the data of ERO2 at the moment after anaesthetized immediately and at the moment when abdomen was closed.|during the surgery|||||||
2550091|NCT02841046|Secondary|Oxygen Consumption（VO2）|oxygen delivery（VO2) in ml•min-1•m-2.Record the data of VO2 at the moment after anaesthetized immediately and at the moment when abdomen was closed.|during the surgery|||||||
2550092|NCT02841046|Secondary|Oxygen Delivery（DO2）|oxygen delivery（DO2) in ml•min-1•m-2.Record the data of DO2 at the moment after anaesthetized immediately and at the moment when abdomen was closed.|during the surgery|||||||
2550093|NCT02841046|Secondary|the Incidence of Adverse Cardiovascular Events|including hypertension,hypotension,tachycardia,bradycardia|during the surgery|||||||
2550094|NCT02841046|Primary|Number of Days Needed for Anal Exsufflation After Surgery|record the number of days needed for anal exsufflation in non-severe patients after gastrointestinal tumor surgery|up to 8 weeks||||days||Standard Deviation|Mean
2550095|NCT02840916|Secondary|Body Fat Percentage (BFP)|The BFP was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks.|up to 3 weeks||||% of body weight||Standard Deviation|Mean
2550096|NCT02840916|Secondary|Waist-to-buttock Ratio (WBR)|The WBR was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks.|up to 3 weeks||||ratio||Standard Deviation|Mean
2550097|NCT02840916|Primary|Body Mass Index (BMI)|The BMI was assessed by an evaluator who was blinded to the intervention details from the beginning through study completion, up to 3 weeks, and 3 months after study completion.|up to 3 weeks, 3 months after study completion||||kg/m^2||Standard Deviation|Mean
2550098|NCT02840721|Secondary|Change From Baseline in Serum Total Soluable Tumor Necrosis Factor-like Ligand 1A (sTL1A)|TL1A is a member of the tumor necrosis factor (TNF) family of cytokines. The investigational product of this study PF-06480605 is a fully human neutralizing antibody against TL1A.|Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, and 26|The analysis population included all participants who received at least 1 dose of PF 06480605 with 1 sTL1A measurement.|||picograms/mL||Standard Deviation|Mean
2550099|NCT02840721|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (HsCRP)|HsCRP is used mainly as a marker of inflammation.|Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, and 26|The analysis population included all participants who received at least 1 dose of PF 06480605 with 1 hsCRP measurement.|||micrograms/deciliter||Standard Deviation|Mean
2550100|NCT02840721|Secondary|Change From Baseline in Fecal Calprotectin|Fecal calprotectin has been used to detect intestinal inflammation (colitis or enteritis) and can serve as a biomarker for inflammatory bowel diseases. Elevated fecal calprotectin levels indicate migration of neutrophils into the intestinal mucosa, which occurs during intestinal inflammation.|Baseline, Weeks 2, 8, 12 and 26|The analysis population included all participants who received at least 1 dose of PF 06480605 with at least 1 fecal calprotectin measurement.|||micrograms/grams||Standard Deviation|Mean
2553725|NCT02770612|Primary|Pain Management and Opioid Usage Measured by Telephone Questionnaire|Outpatient opioid selection and use after discharge|Within 2 weeks postpartum||||number of oxycodone 5mg tablets||Inter-Quartile Range|Median
2550101|NCT02840721|Secondary|Percentage of Participants Who Developed Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)|Serum samples were analyzed using a new ADA assay with acid pre-treatment followed by a more drug-tolerant cell-based NAb assay. For ADA assay with acid pre-treatment, the sample was deemed positive if log titer >=1.30; for cell-based NAb assay, the sample was deemed positive if log titer >=0.699.|Day 1 up to final onsite visit (Week 26)|The analysis population included all enrolled participants who received at least 1 dose of PF 06480605 with at least 1 post-treatment ADA determination.|||percentage of participants|||Number
2550102|NCT02840721|Secondary|Area Under the Concentration-time Profile From Time Zero to Time Tau (AUCtau) of PF-06480605|AUCtau of PF-06480605 was calculated using linear/log trapezoidal method; tau was the dosing interval (=14 days).|30 minutes pre-dose and 1 hour post-dose on Day 85|The analysis population included all enrolled participants who received at least 1 dose of PF-06480605 and had at least 1 derived value of a specific pharmacokinetic (PK) parameter.|||ng.hr/mL||Geometric Coefficient of Variation|Geometric Mean
2550103|NCT02840721|Secondary|Lowest Serum Concentration (Cmin) of PF-06480605|Lowest serum concentration (Cmin) of PF-06480605 was observed directly from data.|30 minutes pre-dose and 1 hour post-dose on Day 85|The analysis population included all enrolled participants who received at least 1 dose of PF-06480605 and in whom at least 1 concentration value was reported.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2550104|NCT02840721|Secondary|Average Serum Concentration (Cav) of PF-06480605|Average serum concentration (Cav) of PF-06480605 was calculated as AUCtau/tau, where tau was the dosing interval (tau=14 days), and AUCtau was the area under the concentration-time profile from time 0 to time tau.|30 minutes pre-dose and 1 hour post-dose on Day 85|The analysis population included all enrolled participants who received at least 1 dose of PF-06480605 and had at least 1 derived value of a specific pharmacokinetic (PK) parameter.|||nanograms (ng)/milliliters (mL)||Geometric Coefficient of Variation|Geometric Mean
2550105|NCT02840721|Secondary|Maximum Serum Concentration (Cmax) of PF-06480605|Maximum serum concentration (Cmax) of PF-06480605 was observed directly from data.|30 minutes pre-dose and 1 hour post-dose on Day 85|The analysis population included all enrolled participants who received at least 1 dose of PF-06480605 and in whom at least 1 concentration value was reported.|||nanograms (ng)/milliliters (mL)||Geometric Coefficient of Variation|Geometric Mean
2550106|NCT02840721|Secondary|Percentage of Participants Achieving Endoscopic Remission at Week 14 - Full Analysis Set|Endoscopic remission at Week 14 was defined as Mayo endoscopic sub-score of 0. The Mayo scoring system was used to assess ulcerative colitis activity, and it ranges from 0 to 12, calculated as sum of 4 sub-scores, with higher scores indicating more severe disease. The 4 sub-scores are stool frequency (0=normal number of stools; 1=1 to 2 stools more than normal; 2= 3 to 4 stools more than normal; 3= 5 or more stools more than normal); rectal bleeding (0=no blood seen; 1=streaks of blood with stools less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes); findings on endoscopy (0=normal or inactive disease; 1=mild disease [erythema, decreased vascular pattern, mild friability]; 2=moderate disease [marked erythema, lack of vascular pattern, friability, erosions]; 3=severe disease [spontaneous bleeding, ulceration]); and physician's global assessment (0=normal; 1=mild disease; 2=moderate disease; 3=severe disease).|Week 14|The analysis population included all participants who received at least 1 dose of PF-06480605.|||percentage of participants||95% Confidence Interval|Number
2550107|NCT02840721|Secondary|Percentage of Participants Achieving Remission at Week 14 - Per Protocol Analysis Set|Remission: total Mayo score <=2 with no individual subscore >1. Mayo scoring system was used to assess ulcerative colitis activity (range: 0 to 12, calculated as sum of 4 subscores, higher scores indicating more severe disease). The 4 subscores are stool frequency (0=normal number of stools; 1=1 to 2 stools more than normal; 2= 3 to 4 stools more than normal; 3= 5 or more stools more than normal); rectal bleeding (0=no blood seen; 1=streaks of blood with stools less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes); findings on modified endoscopy (0=normal or inactive disease; 1=mild disease [erythema, decreased vascular pattern, no friability]; 2=moderate disease [marked erythema, lack of vascular pattern, friability, erosions]; 3=severe disease [spontaneous bleeding, ulceration]); and physician's global assessment (0=normal; 1=mild disease; 2=moderate disease; 3=severe disease).|Week 14|The analysis population included all participants who were eligible for enrollment, not a major protocol violator, with at least 6 out of 7 planned doses received and a final colonoscopy at Week 14.|||percentage of participants||95% Confidence Interval|Number
2550108|NCT02840721|Secondary|Percentage of Participants Achieving Remission at Week 14 - Full Analysis Set|Remission: total Mayo score <=2 with no individual subscore >1. Mayo scoring system was used to assess ulcerative colitis activity (range: 0 to 12, calculated as sum of 4 subscores, higher scores indicating more severe disease). The 4 subscores are stool frequency (0=normal number of stools; 1=1 to 2 stools more than normal; 2= 3 to 4 stools more than normal; 3= 5 or more stools more than normal); rectal bleeding (0=no blood seen; 1=streaks of blood with stools less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes); findings on modified endoscopy (0=normal or inactive disease; 1=mild disease [erythema, decreased vascular pattern, no friability]; 2=moderate disease [marked erythema, lack of vascular pattern, friability, erosions]; 3=severe disease [spontaneous bleeding, ulceration]); and physician's global assessment (0=normal; 1=mild disease; 2=moderate disease; 3=severe disease).|Week 14|The analysis population included all participants who received at least 1 dose of PF-06480605.|||percentage of participants||95% Confidence Interval|Number
2550119|NCT02839902|Secondary|Change From Baseline in Mean Concentration of sd LDL-C in Total Lipids|There were no reporting data for this outcome measure because the data of change in mean concentration of sdLDL-C in total lipids were not collected and analyzed in this study finally. So here the data input for this outcome measure are NA for each arm.|Baseline, Week 4 and Week 8|There were no reporting data for this outcome measure because the data of change in mean concentration of sdLDL-C in total lipids were not collected and analyzed in this study finally.||||||
2550120|NCT02839902|Secondary|Percent Changes From Baseline in Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio in Total Lipids|The reported data are percent of change from baseline in DHA/AA ratio in total lipids at Week 4 and Week 8.|Baseline, Week 4 and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||Percent of Change||Standard Deviation|Mean
2572003|NCT02512393|Primary|Pressure Pain Threshold|Quantitative Sensory Testing (QST) by using pressure pain delivered by a hand-held algometer.|baseline||||kilopascal (kPa)||Standard Deviation|Mean
2550109|NCT02840721|Primary|Percentage of Participants Achieving Endoscopic Improvement at Week 14, Based on Uniformly Minimum-Variance Unbiased Estimator (UMVUE) - Per Protocol Analysis Set|Endoscopic improvement at Week 14 was defined as Mayo endoscopic sub-score of 0 or 1, and without friability. The Mayo scoring system was used to assess ulcerative colitis activity, and it ranges from 0 to 12, calculated as sum of 4 sub-scores, with higher scores indicating more severe disease. The 4 sub-scores are stool frequency (0=normal number of stools; 1=1 to 2 stools more than normal; 2=3 to 4 stools more than normal; 3= 5 or more stools more than normal); rectal bleeding (0=no blood seen; 1=streaks of blood with stools less than half the time; 2=obvious blood with stool most of the time; 3=blood alone passes); findings on endoscopy (0=normal or inactive disease; 1=mild disease [erythema, decreased vascular pattern, mild friability]; 2=moderate disease [marked erythema, lack of vascular pattern, friability, erosions]; 3=severe disease [spontaneous bleeding, ulceration]); and physician's global assessment (0=normal; 1=mild disease; 2=moderate disease; 3=severe disease).|Week 14|The analysis population included all participants who were eligible for enrollment, not a major protocol violator, with at least 6 out of 7 planned doses received and a final colonoscopy at Week 14.|||percentage of participants||95% Confidence Interval|Number
2550110|NCT02840721|Primary|Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria|All scheduled 12-lead ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Number of participants with ECG data meeting pre-specified criteria is presented.|Baseline up to final onsite visit (Week 26)|The analysis population included all participants who received at least 1 dose of PF-06480605 and had both baseline and at least 1 post-baseline ECG evaluation performed.|||Participants|||Count of Participants
2550111|NCT02840721|Primary|Number of Participants With Vital Signs Data Meeting Pre-specified Criteria|Vital signs evaluation included sitting diastolic blood pressure (DBP), systolic blood pressure (SBP), and pulse rate. Sitting blood pressure was measured with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mm Hg). The same size BP cuff which had been properly sized and calibrated was used to measure BP each time. Number of participants with vital signs data meeting pre-specified criteria is presented.|Baseline up to final onsite visit (Week 26)|The analysis population included all participants who received at least 1 dose of PF-06480605.|||Participants|||Count of Participants
2550112|NCT02840721|Primary|Number of Participants With Laboratory Abnormalities|The following parameters were evaluated: hematology (hemoglobin, hematocrit, erythrocytes, erythrocyte mean corpuscular volume, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, and prothrombin time), clinical chemistry (bilirubin, direct bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, urate, sodium, potassium, chloride, calcium, glucose, and creatine kinase), and urinalysis (urine glucose, ketones, urine protein, urine hemoglobin, nitrite, leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, and bacteria).|Day 1 up to final onsite visit (Week 26)|The analysis population included all participants who received at least 1 dose of PF-06480605.|||Participants|||Count of Participants
2550113|NCT02840721|Primary|Number of Participants With Treatment-Emergent Adverse Events, Serious Adverse Events, and Who Withdrew Due to Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious AE (SAE) was any untoward medical occurrence at any dose that (1) resulted in death; (2) was life-threatening (immediate risk of death); (3) required inpatient hospitalization or prolongation of existing hospitalization; (4) resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); (5) resulted in congenital anomaly/birth defect. A treatment-emergent AE (TEAE) was defined as an event that emerged during treatment having been absent pre-treatment, or worsened relative to the pre-treatment state. Causality to study treatment was determined by the investigator.|Day 1 up to final onsite visit (Week 26)|The analysis population included all participants who received at least 1 dose of PF-06480605.|||Participants|||Count of Participants
2550114|NCT02840253|Primary|Tissue Non-invasive Near Infrared Spectroscopy (NIRS)|Change in tissue oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block).|Intraoperative measure||||percentage change per minute||95% Confidence Interval|Number
2550115|NCT02840253|Primary|Cerebral Non-invasive Near Infrared Spectroscopy (NIRS)|Change in cerebral oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block).|Intraoperative measure||||percentage change per minute||95% Confidence Interval|Number
2550116|NCT02839902|Secondary|Percent Change From Baseline in Lipoprotein Particle Numbers in the Blood|"Reported data were percent of changes from baseline in lipoprotein particle numbers in the blood for 4 fractions (CM, VLDL, LDL, and HDL fractions). Data for this outcome measure was reported instead of the outcome measure title of Change from Baseline in particle number of lipids, apoprotein and lipoprotein on registration module (see History of Change of registration)."|Baseline, Week 4 and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||Percent of Change||Standard Deviation|Mean
2550117|NCT02839902|Secondary|Percent Change From Baseline in Concentration of Apolipoproteins in the Blood|Apolipoproteins on this outcome measure include Apolipoprotein AI, AII, B, B-48, B-100, CII, CIII, CII/III, and E. Reported data are percent of change in concentration of these apolipoproteins in the blood at Week 4 and Week 8.|Baseline, Week 4 and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||Percent of Change||Standard Deviation|Mean
2550118|NCT02839902|Secondary|Percent Change From Baseline in Concentration of Lipids in the Blood|Lipids on this outcome measure include Total cholesterol, Triacylglycerol (TG), HDL-C, non-HDL, and Remnant lipoprotein cholesterol (RemL-C). Reported data are percent of change in concentration of these lipids in the blood at Week 4 and Week 8.|Baseline, Week 4 and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||Percent of Change||Standard Deviation|Mean
2550154|NCT02839876|Secondary|Subject Satisfaction at 48 Hours|Overall subject satisfaction with hospital experience at the 48 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied.|48 hours|Only completed participants are included.|||score on a scale||Inter-Quartile Range|Median
2550123|NCT02839902|Secondary|Percent Changes From Baseline in Eicosatrienoic Acid to Arachidonic Acid (T/T) Ratio in Total Lipids|The reported data are percent of change from baseline in T/T ratio in total lipids at Week 4 and Week 8.|Baseline, Week 4 and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||Percent of Change||Standard Deviation|Mean
2550124|NCT02839902|Secondary|Percent Changes From Baseline in Concentration of Fatty Acids in Total Lipids|Fatty acids refer to the following 24 acids; Lauric acid, Myristic acid, Myristoleic acid, Palmitic acid, Palmitoleic acid, Stearic acid, Oleic acid, Linoleic acid, Gamma-linolenic acid, Linolenic acid, Arachic acid, Eicosenoic acid, Eicosadienoic acid, 5-8-11 Eicosatrienoic acid, Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Behenic acid, Erucic acid, Docosatetraenoic acid, Docosapentaenoic acid, Lignoceric acid, Docosahexaenoic acid, and Nervonic acid. The reported data are percent of change from baseline in concentration of these fatty acids in total lipids at Week 4 and Week 8.|Baseline, Week 4 and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||Percent of Change||Standard Deviation|Mean
2550125|NCT02839902|Secondary|Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in High-density Lipoprotein (HDL) Fraction|Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in HDL Fraction at Week 4 and Week 8.|Baseline, Week 4 and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||Percent of Change||Standard Deviation|Mean
2550126|NCT02839902|Secondary|Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Low-density Lipoprotein (LDL) Fraction|Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in LDL Fraction at Week 4 and Week 8.|Baseline, Week 4 and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||Percent of Change||Standard Deviation|Mean
2550127|NCT02839902|Secondary|Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Very Low-density Lipoprotein (VLDL) Fraction|Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in VLDL Fraction at Week 4 and Week 8.|Baseline, Week 4 and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||Percent of Change||Standard Deviation|Mean
2550128|NCT02839902|Secondary|Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Chylomicron (CM) Fraction|Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in CM fraction at Week 4 and Week 8.|Baseline, Week 4 and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||Percent of Change||Standard Deviation|Mean
2550129|NCT02839902|Primary|Percent Change From Baseline in Mean Particle Sizes of Small Dense Low Density Lipoprotein-cholesterol (sdLDL-C) and Low Density Lipoprotein-cholesterol (LDL-C) Monitored by Major 4 Lipid Constituents|"Reported data are percent of change from baseline in mean particle sizes of sdLDL-C and LDL-C monitored by major 4 lipid constituents (cholesterol, triglycerides, free cholesterol, and phospholipid) at Week 4 and Week 8. Here the data were consolidated from results of the two outcome measures (Change in mean particle sizes of sdLDL-C and Change in mean particle sizes of LDL-C) on initial registration information (see History of Change of registration) because sdLDL-C refers to LDL-C which is smaller particle size and heavier density."|Baseline, Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||Percent of Change||Standard Deviation|Mean
2550130|NCT02839902|Primary|Percent Changes From Baseline in Triglycerides (TG) to Cholesterol Ratio in sdLDL Fraction|Reported data are percent of change from baseline in in TG to cholesterol ratio in sdLDL fraction at Week 4 and Week 8.|Baseline, Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||Percent of Change||Standard Deviation|Mean
2550131|NCT02839902|Primary|Percent Changes From Baseline in Concentration of Major 4 Lipid Constituents in Small Dense Low Density Lipoprotein (sdLDL) Fraction|Major 4 lipid constituents refer to cholesterol, triglycerides, free cholesterol, and phospholipid. The reported data are percent of change from baseline in concentration of the each lipid constituents in sdLDL fraction at Week 4 and Week 8.|Baseline, Week 4 and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||Percent of Change||Standard Deviation|Mean
2550132|NCT02839889|Secondary|Complete Evacuation Question With Each Bowel Movement|Change from Baseline in mean values calculated as the post baseline value minus the baseline. The post baseline value is the percentage of days from baseline to study completion with at least one complete bowel evacuation.|Assessed at baseline through Study Completion with each bowel movement, approximately 6 weeks.||||% of days with complete evacuation||Full Range|Mean
2550133|NCT02839889|Secondary|Degree of Straining Question With Each Bowel Movement|"Degree of straining scale is 1 to 5 with 1 being not at all and 5 being an extreme amount. Lower scores are better and higher scores are worse.~Change from baseline in mean values calculated as the post baseline value minus the baseline. Degree of Straining scale change from baseline mean scores calculated from baseline to study completion."|Assessed at baseline through Study Completion with each bowel movement, approximately 6 weeks.||||score on a scale||Full Range|Mean
2550134|NCT02839889|Secondary|Patient Assessment of Constipation Quality of Life (PAC-QOL)|"The PAC-QOL is a 28-item questionnaire divided into 4 subscales. Items 1-4 measure physical discomfort (subscale range 0-16), 5-12 measure psychosocial discomfort (range 0-32), 13-23 measure worries/concerns (range 0-44), and 24-28 measure satisfaction (range 0-20). For each subscale, lower scores are better and higher scores are worse.~The total score is generated by summing the scores of the subscales. This total score ranges from 0-112, with lower scores corresponding to better outcomes, and higher scores corresponding to worse outcomes.~Change from baseline in mean values calculated as post-baseline value minus baseline value for each subscale, and for total. Post-baseline values defined as the mean of day 15 and day 29."|day 1, day 15, day 29||||score on a scale||Full Range|Mean
2550135|NCT02839889|Secondary|Patient Assessment of Constipation Symptoms (PAC-SYM)|"The PAC-SYM is divided into three subscales. Each item is scored 0-4. Items 1-4 measure abdominal symptoms (total subscale range 0-16), items 5-7 measure rectal symptoms (total subscale score 0-12), and items 8-12 measure stool symptoms (total subscale range 0-20). For each subscale, lower scores are better and higher scores are worse.~The total construct score is generated by summing the scores of the subscales. This total score ranges from 0-48, with lower scores corresponding to better outcomes, and higher scores corresponding to worse outcomes.~Change from baseline in mean values calculated as post-baseline value minus baseline value for each scale, and for total. Post-baseline values defined as the mean of day 15 and day 29."|day 1, day 15, day 29||||score on a scale||Full Range|Mean
2550136|NCT02839889|Secondary|Bristol Stool Scale (BSS) Score|"The Bristol Stool Scale classifies the type of bowel movement on a scale from 1-7, based on the appearance of stool. 1 indicates severe constipation, 2 indicates mild constipation, 3-4 indicate a normal bowel movement, 5 indicates that the patient is lacking dietary fiber, 6 indicates mild diarrhea, and 7 indicates severe diarrhea. A better score would trend toward the middle of the scale (ranges 3-4), while scores at either end of the scale correspond to worse outcomes.~Bristol Stool Scale (BSS) Score calculated by the sum of daily BSS scores divided by the number of bowel movements that occurred from baseline to study completion. Change from Baseline calculated as the Baseline value minus the post-baseline value."|Assessed from baseline through Study Completion, approximately 6 weeks.||||score on a scale||Full Range|Mean
2550137|NCT02839889|Secondary|Time to First Post-dose Rescue Free Laxation|Time (in hours) to first post-dose rescue free bowel movement minus first dose date and time.|First dose date to first post-dose rescue free bowel movement||||Hours||Full Range|Mean
2550138|NCT02839889|Secondary|Rescue Free Bowel Movements (RFBM) Responder Rate|Daily diary data will be used to identify RFBMs. The weekly RFBM frequency within each time period will be calculated as: (Total number of RFBMs during the time period of interest/number of days) x 7. RFBM rate calculated from post baseline period.|Assessed from Baseline through Study Completion, approximately 6 weeks.||||RFBMs/days *7||Full Range|Mean
2550139|NCT02839889|Primary|Change From Baseline in Pulse Rate|Change from Baseline in pulse rate at post baseline (visits 2, 3, 4) will be derived as the value at the visit minus the baseline value for the same assessment. The post-baseline values were calculated as a mean of values from visits 2 through 4.|Change from Baseline in pulse rate through study completion, approximately 6 weeks.||||beats per minute||Full Range|Mean
2550140|NCT02839889|Primary|Change From Baseline in Respiratory Rate|Change from Baseline in respiratory rate at post baseline (visits 2, 3, 4) will be derived as the value at the visit minus the baseline value for the same assessment. The post-baseline values were calculated as a mean of values from visits 2 through 4.|Change from Baseline in respiratory rate through study completion, approximately 6 weeks.||||breaths per minute||Full Range|Mean
2550141|NCT02839889|Primary|Change From Baseline in Diastolic Blood Pressure|Change from Baseline in diastolic blood pressure at post baseline (visits 2, 3, 4) will be derived as the value at the visit minus the baseline value for the same assessment. The post-baseline values were calculated as a mean of values from visits 2 through 4.|Change from Baseline in diastolic blood pressure through study completion, approximately 6 weeks.||||mmHg||Full Range|Mean
2550142|NCT02839889|Primary|Change From Baseline in Systolic Blood Pressure|Change from Baseline in systolic blood pressure at post baseline (visits 2, 3, 4) will be derived as the value at the visit minus the baseline value for the same assessment. The post-baseline values were calculated as a mean of values from visits 2 through 4.|Change from Baseline in systolic blood pressure through study completion, approximately 6 weeks.||||mmHg||Full Range|Mean
2550143|NCT02839889|Primary|Electrocardiogram Heart Rate|Changes from Baseline to Visit 3 (approximately Day 15) for Electrocardiogram (ECG) heart rate data will be derived by subtracting the baseline value from the final assessment data.|Change from Baseline at End of Double Blind Phase (Visit 3, approximately day 15)||||beats per minute||Full Range|Mean
2550144|NCT02839889|Primary|Electrocardiogram QTC Interval|Changes from Baseline to Visit 3 (approximately Day 15) for Electrocardiogram (ECG) QTC interval data will be derived by subtracting the baseline value from the final assessment data.|Change from Baseline at End of Double Blind Phase (Visit 3, approximately day 15)||||milliseconds||Full Range|Mean
2550145|NCT02839889|Primary|Adverse Events Associated With Blood Laboratory Result Changes From Baseline|Changes from Baseline to Visit 3 (approximately Day 15) for all patients will be calculated as the post-baseline test value minus the baseline test value.|Change from Baseline at End of Double Blind Phase (Visit 3, approximately day 15)|All abnormal lab values were deemed not clinically significant by Investigators. Therefore, changes did not meet the criteria for an adverse event and changes were not collected.||||||
2550146|NCT02839889|Primary|Daily Opioid Use Change From Baseline|Change from baseline in mean daily opioid dose will be calculated as the post-baseline value minus the baseline value. Positive changes from baseline indicate there was a need to increase the opioid dose. Baseline daily opioid dose is the mean daily opioid dose recorded during the Opioid Induced Constipation (OIC) Confirmation period.|Assessed from screening through study completion, approximately 6 weeks.||||morphine milligram equivalents per day||Full Range|Mean
2550147|NCT02839889|Primary|Numerical Rating Scale (NRS) for Pain Change From Baseline|Change from baseline in mean daily NRS (Numerical Rating Scale) values will be calculated as the post-baseline value minus the baseline. Baseline NRS is the mean daily NRS values recorded during the Opioid Induced Constipation (OIC) Confirmation period. Numeric Rating Scale is 0-10. 0 is no pain and 10 is worst possible pain. Lower values are a better outcome and higher values are a worse outcome. Post-baseline values were calculated as the mean of NRS scores during visits 2-4.|Assessed from screening/Opioid Induced Constipation (OIC) Confirmation period through study completion, approximately 6 weeks.||||score on a scale||Full Range|Mean
2550148|NCT02839876|Other Pre-specified|Cost Associated With Nursing Interventions and Drugs to Treat Opioid-related Adverse Events|mean cost (per patient) related to nursing care of opioid-related adverse events (nausea, vomiting, pruritis, constipation, respiratory depression, dizziness) in $USD|0-72 hours||||US dollars||Standard Deviation|Mean
2550149|NCT02839876|Other Pre-specified|Costs Related to Opioid-related Adverse Events|difference in cost related to treatment of opioid-related adverse events (nausea, vomiting, pruritis, constipation, respiratory depression, dizziness) between groups|0-72 hours||||US dollars||Standard Deviation|Mean
2550158|NCT02839876|Secondary|Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)|Pain scores (using NRS-11 scale) at with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).|1 hour after arrival to PACU||||score on a scale||Inter-Quartile Range|Median
2550159|NCT02839876|Secondary|Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)|Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).|preoperatively||||score on a scale||Inter-Quartile Range|Median
2550160|NCT02839876|Secondary|Worst Pain (Day 30)|Participants are asked to rate their WORST pain on POSTOPERATIVE DAY 30 on an 11-point scale (0=no pain at all, 10=worst imaginable pain).|day 30||||score on a scale||Inter-Quartile Range|Median
2550161|NCT02839876|Secondary|Analgesic Consumption as Measured by Patient Diary|morphine equivalent units of oral opioids and other non-opioids|day 30||||mg||Inter-Quartile Range|Median
2550162|NCT02839876|Secondary|Number of Participants With Opioid-related Adverse Events|Incidence of respiratory desaturation events, nausea, vomiting, pruritis, ileus, and constipation|0-72 hours|Only completed participants are included.|||participants|||Number
2550163|NCT02839876|Secondary|Self-paced Walk Test|Time taken to walk down a hallway 20 m at a safe and quick pace, turn around and return to starting point.|Postoperative day 1|Only completed participants are included.|||seconds||Inter-Quartile Range|Mean
2550164|NCT02839876|Secondary|Number of Participants Able to Complete the Supine to Sit Test|Number of participants able to go from supine to a sitting position independently.|Postoperative day 1|Only completed participants are included.|||Participants|||Count of Participants
2550165|NCT02839876|Secondary|Heel Slide Test|Number of participants who are able to complete the heel-slide test. The subject rests supine and is asked to place the heel of his/her operative side on the contralateral knee, then slide the heel down to the ankle and back in one continuous motion. If the subject can do this, the test is positive. If the subject cannot do this in one motion, or if pain or other factors prevent the test from being performed, the test is negative.|Postoperative day 1|Only completed participants are included.|||Participants|||Count of Participants
2550166|NCT02839876|Secondary|Straight Leg Raise|Number of participants who are able to complete the active straight leg test. The subject rests supine and is asked to lift his/her operative lower limb (with knee extended) until the ankle is 20 cm from level. If the subject can do this, the test is positive.|Postoperative day 1|Only completed participants are included.|||Participants|||Count of Participants
2550167|NCT02839876|Secondary|Subject Satisfaction at 48 Hours (48 Hours)|Overall subject satisfaction with hospital experience at the 48 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied.|48 hours|Only completed participants are included.|||score on a scale||Inter-Quartile Range|Median
2550168|NCT02839876|Secondary|Subject Satisfaction at 24 Hours|Overall subject satisfaction with hospital experience at the 24 hour time point using a simple 11-point Likert scale to quantify global satisfaction. 0=completely unsatisfied, 10=completely satisfied.|24 hours|Only completed participants are included.|||score on a scale||Inter-Quartile Range|Median
2550169|NCT02839876|Secondary|Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (48 Hours)|Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).|48 hours||||score on a scale||Inter-Quartile Range|Median
2550170|NCT02839876|Secondary|Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (36 Hours)|Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).|36 hours||||score on a scale||Inter-Quartile Range|Median
2550171|NCT02839876|Secondary|Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (24 Hours)|Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).|24 hours||||score on a scale||Inter-Quartile Range|Median
2550172|NCT02839876|Secondary|Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (8 Hours)|Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).|8 hours||||score on a scale||Inter-Quartile Range|Median
2550173|NCT02839876|Secondary|Pain Scores, as Measured by the 11-point Numeric Rating Scale (NRS-11) (1 Hour After Arrival to PACU)|Pain scores (using NRS-11 scale) at rest. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).|1 hour after arrival to PACU||||score on a scale||Inter-Quartile Range|Median
2550174|NCT02839876|Secondary|Pain Score, as Measured by the 11-point Numeric Rating Scale (NRS-11) (Preoperatively)|Pain scores (using NRS-11 scale) with active range of motion of the hip. Participants rate their pain on an 11-point scale (0=no pain at all, 10=worst imaginable pain).|preoperatively||||score on a scale||Inter-Quartile Range|Median
2550175|NCT02839876|Secondary|Opioid Consumption (Other)|morphine equivalent units of intravenous and oral opioids|0-48 hours||||morphine milliequivalent||Inter-Quartile Range|Median
2550176|NCT02839876|Primary|24 Hour Opioid Consumption|Cumulative dose of hydromorphone consumed in the first 24 hours postoperatively|24 hours|Only completed participants are included.|||morphine milliequivalent||Inter-Quartile Range|Median
2550177|NCT02839798|Secondary|Mean IDS-SR Score Change (Last Observation Carried Forward)|The Inventory of Depressive Symptomatology (IDS-SR) will be performed as a baseline and after every 5 treatments. It's a standardized self-rating scale for depressive symptom severity used in many clinical trials. IDS-SR total score ranges from 0 to 84; a score of 0-13 is generally accepted to be within the normal range (or reflect clinical remission), while a score of 26 or higher indicates at least moderate severity. Single value was average mean IDS-SR score change.|Baseline through week 6|signed consent and completed at least 1 treatment session|||score on a scale||Standard Deviation|Mean
2550178|NCT02839798|Secondary|Mean HDRS-17 Total Score Change (Last Observation Carried Forward)|The Hamilton Rating Scale for Depression (HRSD-28) will be done at baseline and endpoint assessments. The HRSD-17 score, derived from the HRSD-28, will be analyzed. The HRSD-17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.|Baseline and week 6|signed consent and completed at least 1 treatment session|||score on a scale||Standard Deviation|Mean
2550179|NCT02839798|Primary|Mean MADRS Total Score Change (Last Observation Carried Forward)|The Montgomery-Asberg Depression Rating Scale (MADRS) will be performed as a baseline and endpoint assessments and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The MADRS score ranges from 0 to 60; a score of 0-6 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity.|Baseline to week 6 reported|Signed consent and got at least one treatment session|||score on a scale||Standard Deviation|Mean
2550180|NCT02839772|Secondary|Amharic Dermatology Life Quality Index (DLQI)|The Amharic version of the DLQI has been validated for use in Ethiopia where Amharic is the official working language. The index is divided into 4 sections covering leisure, work and school, personal relationships and treatment. The maximum score of 30 indicates a high impact on quality of life. The lowest score zero. A reduction in the number indicates an improvement in quality of life. Participants were verbally questioned by the clinic nurse or social worker as most participants were illiterate.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.|||units on a scale||Standard Deviation|Mean
2550181|NCT02839772|Secondary|Change in Largest Foot Circumference|Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.|||Centimetres|Foot circumference|Standard Deviation|Mean
2550182|NCT02839772|Secondary|Change in Largest Lower Leg Circumference|Measured by clinic nurse in centimetres with a disposable tape measure at the point of largest circumference on the foot.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.|||Centimetres|Legs|Standard Deviation|Mean
2550183|NCT02839772|Secondary|Correlation Between Number of Work Days Lost Due to Adenolymphangitis and Number of Wounds|Statistical calculation of the correlation between the number of work days lost in the previous month due to leg pain (adenolymphangitis) and the number of wounds present on the lower leg/foot. Wounds on the lower legs/feet may produce a bad odour.|From baseline monthly for 3 months|3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis.Data were pre-specified to be collected and analysed for all participants in a single group.|||Spearman's correlation coefficient|||Number
2550184|NCT02839772|Secondary|Change in Number of Work Days Lost in Previous Month Due to Adenolymphangitis (ADL)|Verbal questioning of participants by clinic nurse or social worker as to number of work days lost due to severe leg pain (adenolymphangitis). Questioning was used as most participants were illiterate.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One leg in the control group and two legs in experimental group were not affected by podoconiosis.Data were pre-specified to be analysed for all participants as a single group.|||Number of work days lost.|||Number
2550185|NCT02839772|Secondary|Number of Wounds on Lower Legs/Feet of Participants.|"Observation and count of number of wounds (all breaches of the stratum corneum including areas of fungal infection) on lower legs/feet by clinic nurse.~Breaches in the skin and areas of fungal infection are more likely to occur in those with an impaired skin barrier function.A reduction in the number of wounds indicates an improvement in SBF."|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data was pre-specified to be analysed for all participants as a single group.|||Wounds|Feet/legs||Number
2550186|NCT02839772|Secondary|Total Number of All Participants With the Presence of a Bad Odour Emanating From Their Lower Limbs.|Change in the presence of bad odour emanating from wounds on participant's lower legs/feet as determined by clinic nurse. Bad odour results in social stigma and impacts of quality of life.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data were pre-specified to be collected and analysed for all participants in a single group.|||Participants|||Number
2550187|NCT02839772|Secondary|Total Number of Trophic Skin Changes (Mossy Changes) All Participants at Baseline and 4th Visit|Total number of observed trophic changes (mossy eruptions on the skin of the lower legs/feet characteristic of podoconiosis) in all participants by clinic nurse at baseline and at 4th visit. Trophic changes were either present or not present.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data were pre-specified to be collected and analysed for all participants in a single group.|||Trophic skin changes|||Number
2550188|NCT02839772|Secondary|Stage of Podoconiosis in Each Leg of All Participants at Baseline and 4th Visit|Podoconiosis Staging System (1-5) used with 5 the most severe stage. This staging system was specifically designed for those with podoconiosis. Legs with stages 1, 2 or 3 were categorised with mild/moderate disease and those with stages 4,5 with severe disease.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One leg in the control group and two legs in experimental group were not affected by podoconiosis. Data were pre-specified to be collected and analysed for all participants as a single group.|||Legs/feet|Legs||Number
2550189|NCT02839772|Primary|Change in Stratum Corneum Hydration at Top of Feet|Stratum corneum hydration measured at a specific point on the middle top of the foot with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One left foot in the control group and one left and one right foot in the experimental group were not affected by podoconiosis so they were not included in the study.|||Arbitrary units|Feet|Standard Deviation|Mean
2550190|NCT02839772|Primary|Change in Stratum Corneum Hydration at Base of Outer Lower Leg|Stratum corneum hydration was measured at the base of the outer lower leg 8 cms above the external malleolus. It was measured with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.|Change from baseline following 3 months of intervention|3 month data missing from one male participant in control group.One left leg in the control group and one right and one left leg in the experimental group were not affected by podoconiosis so they were not included in the study.|||Arbitrary units|Legs|Standard Deviation|Mean
2550191|NCT02839772|Primary|Change in Stratum Corneum Hydration (SCH) at Mid-point Outer Lower Leg.|SCH was measured mid-way between the measurement site at the top of the outer leg and the site at the base of the outer lower leg. It was measured with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group.One left leg in the control group and one right and one left leg in the experimental group were not affected by podoconiosis so they were not included in the study.|||Arbitrary units|Legs|Standard Deviation|Mean
2550192|NCT02839772|Primary|Change in Stratum Corneum Hydration (SCH) at the Top of Outer Lower Legs|Stratum corneum hydration was measured at a specific point at top of outer lower leg (8cms below the head of the fibula) with a MoistureMeter (non-invasive probe).This measures skin capacitance in arbitrary units. It is generally recommended that differences or percentage changes are reported rather than absolute values. Increases in stratum corneum hydration indicate a positive effect on skin barrier function.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.|||Arbitrary units|Legs|Standard Deviation|Mean
2550193|NCT02839772|Primary|Change in TEWL at Top of Feet|"Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the top of the foot. A reduction in TEWL indicates a positive effect on skin barrier function.It is generally recommended that differences or percentage changes are reported rather than absolute values.~TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values."|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in control group. One left foot leg in the control group and one right and one left foot in the experimental group was not affected by podoconiosis so they were not included in the study.|||g/m2/h|Feet|Standard Deviation|Mean
2550194|NCT02839772|Primary|Change in TEWL at Base of Outer Lower Legs|"Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the outer lower leg 8cms above the external malleolus. A reduction in TEWL indicates a positive effect on skin barrier function.It is generally recommended that differences or percentage changes are reported rather than absolute values.~TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values."|Change from baseline following 3 months of intervention|3 month post-intervention data was missing from one male participant in control group.One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.|||g/m2/h|Legs|Standard Deviation|Mean
2550195|NCT02839772|Primary|Change in TEWL at Mid-point Outer Lower Legs|Trans-epidermal water loss (TEWL) was measured with a Vapometer (non- invasive probe) at a specific point on the outer lower leg. This was mid-way between the measurement site at the top of the outer leg and the site at the base of the outer lower leg. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.|Change from baseline following 3 months of intervention|3 month post intervention data missing from one male participant in the control group. One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.|||g/m2/h|Legs|Standard Deviation|Mean
2550196|NCT02839772|Primary|Change in TEWL at Top of Outer Lower Legs|Trans-epidermal water loss (TEWL) was measured with a Vapometer (non-invasive probe) on the outer lower leg 8 cms below the head of the fibula. TEWL is the water lost through the skin under non-sweating conditions. It is the major indicator of healthy skin. A reduction in TEWL indicates a positive effect on skin barrier function. It is generally recommended that differences or percentage changes are reported rather than absolute values.|Change from baseline following 3 months of intervention|3 month post intervention data was missing from one male participant in the control group. One left leg in the control group and one right and one left leg in the experimental group was not affected by podoconiosis so they were not included in the study.|||g/m2/h|Legs|Standard Deviation|Mean
2550197|NCT02839746|Secondary|Reasons for no Longer Receiving Pradaxa® Treatment|"Reasons for no longer receiving Pradaxa® treatment categorized as below:~Treatment change (Change of treatment (by patient or by investigator)~Adverse event (Diarrhea, gastrointestinal discomfort, rectorrhagia, dyspepsia)~Exitus~Others"|7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)|Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria.|||Participants|||Count of Participants
2550198|NCT02839746|Secondary|Reason for Changing the Dose of Pradaxa®: 110 mg/Bid to 150 mg/Bid|"Reasons for for changing the dose of Pradaxa®: 110 mg/bid to 150 mg/bid are categorized as below:~1] High risk of bleeding 2] Moderate renal failure 3] >80 years 4] Other reason"|7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)|Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria.|||Participants|||Count of Participants
2550199|NCT02839746|Secondary|Reason for Changing the Dose of Pradaxa®: 150 mg/ Twice Daily (Bid) to 110 mg/Bid|"Reasons for for changing the dose of Pradaxa®: 150 mg/bid to 110 mg/bid are categorized as below:~1] High risk of bleeding 2] Moderate renal failure 3] >80 years 4] Other reason"|7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)|Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria.|||Participants|||Count of Participants
2550200|NCT02839746|Secondary|Patient Characteristics at Baseline - Reasons for Switching From VKAs to Pradaxa®|"Categories of reasons for switching from VKAs to Pradaxa® are as below:~Hypersensitivity (Hypersensitivity to the drug)~Intracranial haemorrhage (Patients with a history of intracranial haemorrhage (ICH) (except during the acute phase) in whom the benefits of anticoagulation were deemed to outweigh the risk of haemorrhage)~Ischaemic stroke (Patients with ischaemic stroke who present clinical and neuroimaging criteria indicating a high risk of ICH)~Arterial thromboembolic episodes (Patients undergoing treatment with VKAs, suffering from severe arterial thromboembolic episodes despite good INR control)~INR not in range (Patients who have started treatment with VKAs in whom it is not possible to keep the INR in range (2-3) despite good therapeutic compliance)~INR management (Lack of access to conventional INR management)~Pts decision (Patient's decision)~Others.~A single patient may have specified more than one reason"|Baseline|Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria.|||Participants|||Count of Participants
2550201|NCT02839746|Secondary|Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration|Vitamin K Antagonist (VKA) treatment duration is one of the baseline patient characteristics.|Baseline|Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria.|||Months||Standard Deviation|Mean
2550202|NCT02839746|Secondary|Patient Characteristics at Baseline - Creatinine Clearance|Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.|Baseline|Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria.|||millilitre/ minute [mL/min]||Standard Deviation|Mean
2550203|NCT02839746|Secondary|Patient Characteristics at Baseline - Categorical Parameters|"Categorical parameters of the patient characteristics at baseline included age, Risk factors associated with stroke and/or haemorrhage in the medical history (MH), co-morbidities (CoMo), concomitant medication (CM) and dosing of Pradaxa® (DoP).~Haemorrhagic risk (HAS-BLED) is categorized as Low risk (score 0), Moderate risk (score 1-2) and High Risk (score ≥3). Thromboembolic risk (CHA2DS2-VASc) is categorized as Low risk (score 0 in male and 1 in female), Moderate risk (score 1 in male and 2 in female) and High Risk (score ≥2 in male and ≥3 in female).~Stages of kidney disease are categorized based on Cockcroft-Gault review as below:~No kidney failure (> 80 ml/min), Mild kidney failure (50-80 ml/min), Moderate kidney failure (30-49 ml/min), Severe kidney failure (15-29 ml/min) and End-stage kidney failure/dialysis (< 15 ml/min)."|Baseline|Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria.|||Participants|||Count of Participants
2550204|NCT02839746|Secondary|Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score|CHA2DS2-VASc stroke risk score is calculated based on following conditions: Congestive heart failure/left ventricular dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus,Stroke/Transient Ischaemic Attack (TIA)/thromboembolism,Vascular disease (history of myocardial infarction, peripheral artery disease or aortic plaque) ,Age 65-74, Sex category. HAS-BLED bleeding risk score is calculated based on following conditions: Uncontrolled hypertension with Systolic Blood pressure (SBP) ≥ 160 mmHg,Kidney failure,liver failure,History of stroke,History of bleeding, anaemia or predisposition to bleeding,Unstable/high or poor international normalized ratio (INR) (<60% of time within therapeutic range),Elderly (>65 years),Medications that affect haemostasis,Consumptions of ≥8 alcoholic drinks per week.CHA2DS2-VASc stroke risk score & HAS-BLED bleeding risk score range from 0 to 9 with 0 being outcome with low stroke risk for CHA2DS2-VASc and being with low bleeding risk for HAS-BLED.|Baseline|Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria.|||unit on scale||Standard Deviation|Mean
2550205|NCT02839746|Primary|Mean of Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) Score at Last Assessment Compared to Second Assessment|"The PACT-Q is self-administered quest. which was developed as means to investigate patients satisfaction with anticoagulant treatment & treatment convenience in patients with DVT, PE or AF. The PACT-Q2 quest. is made up of two domains: 1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question, &converting to a scale from 0 to 100. 2) Satisfaction with the anticoagulant treatment (7 items):This domain is calculated by adding scores for each of the 7 items in question, & converting to a scale from 0 to 100. The missing items have been replaced by the mean of non-missing items of dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction.~The two domain scores are presented for Visit 2( second assessment), Visit 3 (last assessment) as mean and standard deviation (SD)."|7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)|Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria. The analyses were performed based on actual anticoagulant treatment (AT) received by pts (i.e. “as-treated” analysis),so that pts who discontinued the initial AT during time of an assessment were excluded from all analyses where data from that assessment was included|||unit on scale||Standard Deviation|Mean
2550214|NCT02839330|Secondary|Secondary Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Haemagglutination Inhibition (HI) Titer: Day 22/Day 1, Day 43/Day 1 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)|The GMR of HI titers (Day 22/Day 1, Day 43/Day 1) is presented for the vaccine groups and age cohort. CHMP criterion for subjects aged 18 to <60 years: GMR is >2.5. CHMP criterion for subjects aged ≥60 years: GMR is >2.0.|Day 1, Day 22, Day 43|PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.|||ratio||95% Confidence Interval|Number
2550252|NCT02838420|Secondary|Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by Investigator Using RECIST v1.1||Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)||2020-12-31|12/2020||||
2550206|NCT02839746|Primary|Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Last Assessment Compared to Baseline Assessment|"The PACT-Q is self-administered quest. which was developed as means to investigate patients satisfaction with anticoagulant treatment & treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 quest. is made up of two domains: 1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question, &converting to a scale from 0 to 100. 2) Satisfaction with the anticoagulant treatment (7 items):This domain is calculated by adding scores for each of the 7 items in question, & converting to a scale from 0 to 100.~The missing items have been replaced by the mean of non-missing items of the dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction.~The two domain scores are presented for Baseline, Visit 3 (last assessment) as mean and standard deviation (SD)."|When planned to be switched from VKA to Pradaxa® (At baseline, Visit 1), 125 to 365 days after starting treatment with Pradaxa® (continuation period, Visit 3)|Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria.The analyses were performed based on actual anticoagulant treatment (AT) received by pts (i.e. “as-treated” analysis),so that pts who discontinued the initial AT during time of an assessment were excluded from all analyses where data from that assessment was included|||Units on Scale||Standard Deviation|Mean
2550207|NCT02839746|Primary|Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Second Assessment Compared to Baseline Assessment|The PACT-Q is self-administered quest. which was developed as means to investigate patients' satisfaction with anticoagulant treatment & treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). PACT-Q2 quest. is made up of two domains: (1) Convenience (13 items): This domain is calculated by adding inverted scores (6-item score) for each of the 13 items in question & converting to a scale from 0 to 100. (2) Satisfaction with the anticoagulant treatment (7 items): This domain is calculated by adding scores for each of the 7 items in question & converting to a scale from 0 to 100. The missing items have been replaced by the mean of non-missing items of the dimension (if 50% of items were completed, non-missing), in order to calculate domains score. The higher the score, the higher the convenience/satisfaction. The two domain scores are presented for Baseline, Visit 2 (second assessment) as mean & standard deviation (SD).|When planned to be switched from VKA to Pradaxa® (At baseline, Visit 1), 7 to 124 days after starting treatment with Pradaxa® (initiation period, Visit 2)|Eligible pts: All pts fulfilling all inclusion criteria and no exclusion criteria. The analyses were performed based on actual anticoagulant treatment (AT) received by pts (i.e. “as-treated” analysis),so that pts who discontinued the initial AT during time of an assessment were excluded from all analyses where data from that assessment was included|||Units on Scale||Standard Deviation|Mean
2550208|NCT02839681|Secondary|Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Participants on the Safety run-in phase was assessed for approximately two months and 5 days.||||Participants|||Count of Participants
2550209|NCT02839681|Secondary|Overall Survival|Length of time from start of treatment to death from any cause.|At Death, an average of 7.5 weeks after start of first cycle for both patients.||||Weeks||95% Confidence Interval|Median
2550210|NCT02839681|Secondary|Duration of Response|Duration of Response is from the time measurement criteria are met for Complete Response (CR) or Partial Response (PR). Length of time criteria are met for partial response or complete response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). A complete response is disappearance of all target lesions. A partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|At Disease Progression, approximately 6 weeks from start of treatment|No participant met the criteria for a complete response or partial response.||||||
2550211|NCT02839681|Secondary|Progression Free Survival|Length of time from start of treatment to time of progression or death, whichever occurs first. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).|At Disease Progression, approximately 6 weeks.||||Weeks||95% Confidence Interval|Median
2550212|NCT02839681|Primary|Proportion of Subjects Who Experienced a Partial or Complete Response|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). A complete response is disappearance of all target lesions. A partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|6 weeks||||proportion of participants|||Number
2550213|NCT02839681|Primary|Recommended Phase 2 Dose (RP2D)|The highest dose tested at which no more than 1 dose limiting toxicity occurs. A dose limiting toxicity is defined as any treatment emergent adverse event (TEAE) (i.e., absolute neutrophil count <500/mm^3 for ≥7 days) occurring during Cycle 1 and regarded to be at least possibly related to anetumab ravtansine.|21 days after initiation of study therapy|This outcome measure was not done because the study was terminated due to slow, insufficient accrual.||||||
2550309|NCT02838134|Secondary|Length of Pneumoperitoneum|Intraoperative parameter of duration of pneumoperitoneum|Day 0: once, up to 240 minutes||||minutes||Standard Deviation|Mean
2550215|NCT02839330|Secondary|Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)|Percentage of subjects achieving seroconversion (defined as: HI titer ≥1:40 for subjects negative at baseline [HI titer <1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI titer ≥1:10]) on Day 22, and Day 43 by vaccine group (aH5N1c or placebo) and by age cohort (18 to <60 years of age and ≥60 years of age)|Day 22, and Day 43|PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.|||percentage of subjects||95% Confidence Interval|Number
2550216|NCT02839330|Secondary|Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)|The percentage of subjects with HI titer ≥1:40 data over time by vaccine group and age cohort. Committee for Medicinal Products for Human Use (CHMP) criterion for subjects aged 18 to <60 years: The percentage of subjects achieving an HI titer ≥1:40 is >70%. CHMP criterion for subjects aged ≥60 years: The percentage of subjects achieving an HI titer ≥1:40 is >60%.|Day 1, Day 22, Day 43, and Day 183|PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.|||percentage of subjects||95% Confidence Interval|Number
2550217|NCT02839330|Secondary|Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and By Age Cohort (18 to <60 Years of Age and ≥60 Years of Age)|Hemagglutination inhibition (HI) GMTs were assessed over time for the vaccine group and age cohort. Adjusted estimates of GMTs, and their associated 95% CIs at Day 1, Day 22, Day 43 and Day 183 were computed using ANCOVA with factors for treatment (active treatment groups or placebo), center and a covariate for the effect defined by the log-transformed prevaccination antibody titer (Day 1).|Day 1, Day 22, Day 43 and Day 183|PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.|||titer||95% Confidence Interval|Number
2550218|NCT02839330|Secondary|Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).|Percentage of subjects achieving seroconversion (defined as: HI titer ≥1:40 for subjects negative at baseline [HI titer <1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI titer ≥1:10]) on Day 22, and Day 43 by vaccine group (aH5N1c or placebo) and by age cohort (18 to <65 years of age and ≥65 years of age).|Day 22, and Day 43|PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.|||percentage of subjects||95% Confidence Interval|Number
2550219|NCT02839330|Secondary|Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).|"The percentage of subjects with HI titer ≥1:40 data over time by vaccine group and age cohort are presented. CBER criterion for subjects aged 18 to <65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%.~CBER criterion for subjects aged ≥65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 60%."|Day 1, Day 22, Day 43 and Day 183|PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.|||percentage of subjects||95% Confidence Interval|Number
2550220|NCT02839330|Secondary|Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age).|Estimates of hemagglutination inhibition (HI) GMTs, and their associated 95% CIs at Day 1, Day 22, Day 43 and Day 183 were computed using ANCOVA with factors for treatment (active treatment groups or placebo), center and a covariate for the effect defined by the log-transformed prevaccination antibody titer (Day 1).|Day 1, Day 22, Day 43, and Day 183|PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.|||titer||95% Confidence Interval|Geometric Mean
2550221|NCT02839330|Primary|Percentages of Subjects Reporting SAEs, AESIs, NOCD, AEs Leading to Vaccine/Study Withdrawal, and Medically Attended AEs, and Concomitant Medications Associated With These Events as Collected From Day 1 to Day 387, by Vaccine Group.|Percentages of subjects with any adverse events (AE), adverse events of special interest (AESI), new onset of chronic disease (NOCD), and serious adverse event (SAE) through study termination by treatment group.|Day 1 to Day 387|The unsolicited safety set consisting of all subjects who received a study vaccination and who underwent any AEs assessment (ie, a subject did not have to have any AEs) was used for analysis.|||percentage of subjects|||Number
2550222|NCT02839330|Primary|Percentages of Subjects With Any Unsolicited AEs Reported Through 21 Day After Vaccination|Percentages of subjects with any unsolicited AEs reported through 21 days after each (first and second) and any (first or second) vaccination by treatment group.|Day 1 to Day 43|The unsolicited safety set consisting of all subjects who received a study vaccination and who underwent any AEs assessment (ie, a subject did not have to have any AEs) was used for analysis.|||percentage of subjects|||Number
2550236|NCT02838901|Secondary|Cerebral Perfusion Imaging|Participants from each group who had an MRI at baseline will be randomly selected to have a repeat MRI perfusion scan at 30 days. Cerebral blood flow will be measured by MRI perfusion scanning (arterial spin labeling) in the region of the stroke.|30 days|MRI cerebral perfusion data could not be analyzed because of a change in the measurement of perfusion after the first participant was enrolled.||||||
2550223|NCT02839330|Primary|Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination|Percentages of subjects with solicited local, solicited systemic, and other AEs as measured for 7 days (inclusive) following each vaccination (first and second) and any (first or second) vaccination, by treatment group and calculated for several time intervals after vaccination : 30 minutes, 1 to 3 days (without 30 minutes), 4 to 7 days, and 1 to 7 days (without 30 minutes), and 1 to 3 days (including 30 minutes) and 1 to 7 days (including 30 minutes). Analysis for intervals of the first 30 minutes, days 1 to 3, and days 4 to 7 was not performed.|Day 1 to Day 7|The overall safety set consisting of all subjects who received a study vaccination who underwent any assessment of local and systemic site reaction and/or assessment of any use of analgesics/antipyretics was used for analysis.|||percentage of subjects|||Number
2550224|NCT02839330|Primary|Primary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 at Day 43 by Age Cohort|Percentage of subjects with HI titer ≥ 1:40 at Day 43 was assessed by age cohort (18 to <65 years of age and ≥65 years of age) for the pooled lots. Center for Biologics Evaluation and Research (CBER) criterion for subjects aged 18 to <65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%. CBER criterion for subjects aged ≥65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 60%.|Day 1, Day 43|The PPS consisting of all subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons was used for analysis.|||percentage of subjects||95% Confidence Interval|Number
2550225|NCT02839330|Primary|Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot|Hemagglutination Inhibition (HI) GMT was assessed at Day 1 and Day 43 for 3 consecutively produced lots.|Day 1, Day 43|Per Protocol Set (PPS) - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample (lot-to-lot consistency) at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons.|||geometric mean titer||95% Confidence Interval|Geometric Mean
2550226|NCT02839200|Secondary|Change in Subjective Wake After Sleep Onset (sWASO) From Baseline to Week 4|sWASO is the self-reported time spent awake after sleep onset as reported in the sleep diary.|Baseline and Week 4||||Minutes||Standard Deviation|Mean
2550227|NCT02839200|Secondary|Change in Subjective Latency to Sleep Onset (sLSO) From Baseline to Week 4|sLSO is the self-reported time to fall asleep, as reported in the sleep diary|Baseline and Week 4||||Minutes||Standard Deviation|Mean
2550228|NCT02839200|Secondary|Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2|LPS is the duration of time in minutes from lights off to persistent sleep onset as determined by PSG|Baseline and Days 1&2||||Minutes||Standard Deviation|Mean
2550229|NCT02839200|Primary|Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2|WASO is the time in minutes spent awake after onset of persistent sleep until lights on as determined by polysomnography (PSG)|Baseline and Days 1&2||||minutes||Standard Error|Least Squares Mean
2550230|NCT02838901|Secondary|Modified Rankin Score|Modified Rankin Scale is a measure of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scores range from 0 (no symptoms) to 5 (bedridden in a nursing home). Lower scores denotes better outcomes.|90 days|Only 6 participants in the active and 8 in the placebo returned for the 90 day visit and therefore modified Rankin could not be ascertained.|||units on a scale||Inter-Quartile Range|Mean
2550231|NCT02838901|Secondary|Modified Rankin Score|Modified Rankin Scale is a measure of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scores range from 0 (no symptoms) to 5 (bedridden in a nursing home). Lower scores denotes better outcomes.|30 days|Only 8 participants in the active and 8 in the placebo returned for the 30 day visit in order to measure the modified Rankin score.|||units on a scale||Inter-Quartile Range|Mean
2550232|NCT02838901|Secondary|Montreal Cognitive Assessment (MoCA) Score|Cognition is measured with the Montreal Cognitive Assessment. Cognition is measured with the Montreal Cognitive Assessment. MoCA is a 30 question test that assesses different types of cognitive abilities, including orientation, short-term memory, executive function, language abilities, attention and visuospatial ability. Scores on the MoCA range from zero to 30, higher scores denotes better outcomes.|90 days|Only 5 participants in the active and 8 in the placebo were able to complete the MoCA at 90 days.|||units on a scale||Inter-Quartile Range|Mean
2550233|NCT02838901|Secondary|Montreal Cognitive Assessment (MoCA) Score|Cognition is measured with the Montreal Cognitive Assessment. MoCA is a 30 question test that assesses different types of cognitive abilities, including orientation, short-term memory, executive function, language abilities, attention and visuospatial ability. Scores on the MoCA range from zero to 30, higher scores denotes better outcomes.|30 days|Only 5 participants in the active and 8 in the placebo were able to complete the MoCA at 30 days.|||units on a scale||Inter-Quartile Range|Mean
2550234|NCT02838901|Secondary|Upper Extremity Grip Strength|The hand grip strength test is designed to replicate the grip strength required to undertake officer survival and firearms training. The test is completed using a dynamometer which measures grip strength in kilograms. The score ranges from 0-90kg, higher score denotes better outcomes.|90 days|Only 6 in the active and 7 in the placebo had grip strength measured at 90 days. Affected refers to the upper extremity that was affected by the stroke, and unaffected refers to the upper extremity not affected by the stroke.|||kg||Inter-Quartile Range|Mean
2550235|NCT02838901|Secondary|Upper Extremity Grip Strength|The hand grip strength test is designed to replicate the grip strength required to undertake officer survival and firearms training. The test is completed using a dynamometer which measures grip strength in kilograms (kg). The score ranges from 0-90kg, higher score denotes better outcomes.|30 days|Only 6 participants in each group had grip strength measured at 30 days. Affected refers to the upper extremity that was affected by the stroke, and unaffected refers to the upper extremity not affected by the stroke.|||kg||Inter-Quartile Range|Mean
2550655|NCT02829918|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from first treatment to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1), or death due to any cause.|Up to 36 months|46 participants evaluable|||months||95% Confidence Interval|Median
2550237|NCT02838901|Secondary|Gait Speed Change From Baseline|Gait speed is measured by the time it takes to walk 10 meters. Baseline was reported.Change in gait speed from baseline was assessed at 30 and 90 days. Non-ambulatory at baseline is defined as gait speed less than 0.1 m/s.|baseline, 30, and 90 days|There were 8 participants in the Active and 8 in the placebo because they did not follow-up at 30 days. BL ambulatory refers to only those participants were able to walk at baseline immediately after enrollment. For this analysis, there were only 6 participants in the active and 7 in the placebo at 30 days and 4 and 5 at 90 days, respectively.|||m/s||Inter-Quartile Range|Median
2550238|NCT02838901|Primary|Change in Plasma Nitrite Levels, Micromoles/Liter|This is the proof-of-concept to see if plasma levels change in those randomized to the active beet juice compared to placebo. Comparing baseline values against values at 30 days.|after 30 days of treatment|The median treatment-specific changes in nitrate were analyzed using comparison of pre to post-dosing plasma on day 1. Beetroot It Beetroot juice (Active) was associated with an increase in plasma nitrate and a trend towards increased nitrite levels. The analysis included 8 participants in active and 7 in placebo based on follow-up at 30 d.|||micromoles/L||Inter-Quartile Range|Median
2550239|NCT02838901|Primary|Change in Plasma Nitrate Levels, Micromoles/Liter|This is the proof-of-concept to see if plasma levels change in those randomized to the active beet juice compared to placebo. Comparing baseline values against values at 30 days.|after 30 days of treatment|The median treatment-specific changes in nitrate were analyzed using comparison of pre to post-dosing plasma on day 1. Beetroot It Beetroot juice (Active) was associated with an increase in plasma nitrate and a trend towards increased nitrite levels. The analysis included 8 participants per group since 2 did not come back for follow-up at 30 days.|||micromoles/L||Inter-Quartile Range|Median
2550240|NCT02838901|Primary|Number of Participants With Adverse Treatment-altering Events|Adverse events that lead to treatment discontinuation|30 days||||participants|||Number
2550241|NCT02838901|Primary|Adherence With Intervention|The primary outcome for this trial is feasibility, which will be measured by how well the participants followed instructions on taking Beet It organic beetroot juice or placebo once a day for 30 days.|30 days|Two participants were lost to follow-up by 30 days, therefore the analysis included 8 participants in each group.|||percentage of participants||Inter-Quartile Range|Mean
2550242|NCT02838420|Secondary|Time to Cmax (Tmax) of Alectinib and Its Metabolite|Tmax was collected for both alectinib and its major metabolite, M4, and was based on their concentrations in plasma over time.|Baseline and Week 4 predose (within 2 hours before administration of study drug)|The PK evaluable population for this outcome measure was a subset of frequent-sampling Chinese participants who received any dose of alectinib, and who had at least one quantifiable post-baseline PK sample available. This outcome measure was specific to the alectinib arm, and no data was collected from participants in the crizotinib arm.|||Hour (hr)||Standard Deviation|Mean
2550243|NCT02838420|Secondary|Maximum Plasma Concentration Observed (Cmax) of Alectinib and Its Metabolite|Cmax was collected for both alectinib and its major metabolite, M4, and was based on their concentrations in plasma over time.|Baseline and Week 4 predose (within 2 hours before administration of study drug)|The PK evaluable population for this outcome measure was a subset of frequent-sampling Chinese participants who received any dose of alectinib, and who had at least one quantifiable post-baseline PK sample available. This outcome measure was specific to the alectinib arm, and no data was collected from participants in the crizotinib arm.|||Nanograms/milliliter (ng/mL)||Standard Deviation|Mean
2550244|NCT02838420|Secondary|Area Under the Plasma Concentration-time Curve (AUC) of Alectinib and Its Metabolite|AUC was collected for both alectinib and its major metabolite, M4, and was based on their concentrations in plasma over time.|Baseline and Week 4 predose (within 2 hours before administration of study drug)|The PK evaluable population for this outcome measure was a subset of frequent-sampling Chinese participants who received any dose of alectinib, and who had at least one quantifiable post-baseline PK sample available. This outcome measure was specific to the alectinib arm, and no data was collected from participants in the crizotinib arm.|||Hours*nanogram/milliliter (hr*ng/mL)||Standard Deviation|Mean
2550245|NCT02838420|Secondary|Time to Deterioration Assessed Using EORTC Quality of Life Questionnaire-Lung Cancer Module (QLQ-LC13) Score||Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)||2020-12-31|12/2020||||
2550246|NCT02838420|Secondary|Time to Deterioration Assessed Using EORTC Quality of Life Questionnaire-Core (QLQ-C30) Score||Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)||2020-12-31|12/2020||||
2550247|NCT02838420|Secondary|Percentage of Participants With Non-serious Adverse Events and Serious Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to overall period of approximately 40 months|The safety population was defined as all participants who received at least one dose of study drug.|||Percentage of Participants|||Number
2550248|NCT02838420|Secondary|Overall Survival Time||Baseline, until death (up to overall period of approximately 40 months)||2020-12-31|12/2020||||
2550249|NCT02838420|Secondary|Duration of Response (DOR) Assessed by Investigator Using RECIST v1.1||Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)||2020-12-31|12/2020||||
2550250|NCT02838420|Secondary|Time to Progression of Disease in the CNS as Determined by IRC Using Response Assessment in Neuro-Oncology (RANO)||Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)||2020-12-31|12/2020||||
2550251|NCT02838420|Secondary|Time to Progression of Disease in the CNS as Determined by IRC Using RECIST v1.1||Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)||2020-12-31|12/2020||||
2550253|NCT02838420|Secondary|PFS as Determined by Independent Review Committee (IRC) Using RECIST v1.1|PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as determined by an independent review committee, or to death from any cause, whichever occurred first.|Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 40 months)||2020-12-31|12/2020||||
2550254|NCT02838420|Primary|Progression-Free Survival (PFS) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1|PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as determined by the investigators, or to death from any cause, whichever occurred first.|From the date of randomization to the date of the first documented disease progression or death, whichever occurred first (up to overall period of approximately 40 months)|The primary analysis population for efficacy was the intent-to-treat (ITT) population, defined as all randomized participants.|||Months||95% Confidence Interval|Median
2550255|NCT02838407|Secondary|Number of Subjects With Radiological Results|Radiological results included x-ray, result normality, relationship of abnormality to BAL sampling.|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.|||Participants|||Count of Participants
2550256|NCT02838407|Secondary|Erythrocyte Sedimentation Rate (ESR) Laboratory Results|Laboratory results for ESR were expressed in millimeters per hour (mm/hr).|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.|||mm/hr||Standard Deviation|Mean
2550257|NCT02838407|Secondary|C-reactive Protein (CRP) Laboratory Results|Laboratory results for CRP were expressed in milligrams per litre (mg/L).|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.|||mg/L||Standard Deviation|Mean
2550258|NCT02838407|Secondary|White Blood Cells (WBC) Laboratory Results|Laboratory results for WBC were expressed in 10^9 cells per liter (10^9 cells/L).|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.|||10^9 cells/L||Standard Deviation|Mean
2550259|NCT02838407|Secondary|Number of Subjects With Laboratory Results|Laboratory results included blood sample results available, white blood Cell (WBC) count analysed, WBC reference range, Clinically relevant to the suspected chronic lower respiratory tract infection (LRTI) in the child if out of the range of WBC [LRTI-WBC], CRP (C-reactive protein) reference range, CRP groups, Clinically relevant to the suspected chronic LRTI in the child if out of the range of CRP [LRTI-CRP], ESR (Erythrocyte sedimentation rate) analysed, ESR reference range and Clinically relevant to the suspected chronic LRTI in the child if out of the range of ESR [LRTI-ESR].|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.|||Participants|||Count of Participants
2550260|NCT02838407|Secondary|Number of Subjects With Clinical Characteristics|Clinical characteristics included affections/pre-conditions, affection episodes, number of children living in a household, children in day-care centres, exposure to cigarette smoke.|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.|||Participants|||Count of Participants
2550261|NCT02838407|Secondary|Number of Subjects With Antibiotics and Other Medications Administered|Medication history referred to antibiotics administered in the past 6 months, drug names, antibiotic information source, other medications administered during the past 6 months, information source.|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.|||Participants|||Count of Participants
2550262|NCT02838407|Secondary|Number of Subjects With Haemophilus Influenzae Type b Vaccination History Characteristics|Haemophilus influenzae type b vaccination history included vaccination, Haemophilus influenzae type b vaccine doses (1-4), medical history source validated or not.|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.|||Participants|||Count of Participants
2550263|NCT02838407|Secondary|Number of Subjects With Flu Vaccination History Characteristics|Flu vaccination history included vaccination, Flu vaccine doses (1-5), medical history source validated or not.|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.|||Participants|||Count of Participants
2550264|NCT02838407|Secondary|Number of Subjects With Pneumococcal Vaccination History Characteristics|Pneumococcal vaccination history characteristics included vaccination, pneumococcal vaccines received (Prevnar only, Prevnar 13 only, Synflorix only, Mix of vaccines), Prevnar only doses (1-4), Prevnar 13 only doses (1-4), Synflorix only doses (4), medical history source validated or not.|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.|||Participants|||Count of Participants
2550265|NCT02838407|Secondary|Mean Gestational Age of Subjects|General medical history included mean gestational age.|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.|||Weeks||Standard Deviation|Mean
2550656|NCT02829918|Secondary|Overall Survival (OS)|OS is defined as the time from enrollment to the date of death.|Up to 36 months|||||||
2572004|NCT02512393|Primary|Heat Pain Tolerance|Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.|day 5||||Celsius||Standard Deviation|Mean
2550266|NCT02838407|Secondary|Number of Subjects Presenting General Medical History Characteristics|General medical history characteristics included: any pre-existing conditions, congenital chromosomal abnormality, prematurity (less than 37 weeks) neonatal problems, chronic renal failure, immune system disorder (including auto-immune), atopic dermatitis, clinician-confirmed eczema, asthma and other.|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.|||Participants|||Count of Participants
2550267|NCT02838407|Secondary|Number of Subjects With Body Mass Index (BMI) Characteristics|Demographic characteristics included body mass index (BMI) whose z-scores were measures of relative weight adjusted for child age and sex.|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.|||Participants|||Count of Participants
2550268|NCT02838407|Secondary|Mean Height of Subjects|Demographic characteristics included height which was expressed in centimeters (cm).|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.|||Centimeters||Standard Deviation|Mean
2550269|NCT02838407|Secondary|Mean Weight of Subjects|Demographic characteristics included weight which was expressed in kilograms (kg).|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.|||Kilograms||Standard Deviation|Mean
2550270|NCT02838407|Secondary|Subject Gender|Demographic characteristics included gender: female and male.|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.|||Participants|||Count of Participants
2550271|NCT02838407|Secondary|Mean Age of Subjects|Demographic characteristics included age, which was expressed in months.|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling and/ or nasopharyngeal swab sampling results available.|||Months||Standard Deviation|Mean
2550272|NCT02838407|Secondary|Number of H. Influenzae and M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response From Quantitative Positive Subjects, for Beta-lactamase|"Antimicrobial response of H. influenzae and M. catarrhalis was tested for Beta-lactamase (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).~Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.~Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different (unique) pathogen. Isolates were considered unique based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered unique, and both isolates were retained in the analyses.~Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses."|From Day 0 to Year 2|The analysis was performed on the H. influenzae or M. catarrhalis unique isolates from quantitative positive subjects who were included in the ATP cohort.|||Unique isolates of subjects|||Number
2550273|NCT02838407|Secondary|Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Quantitative Positive Subjects, for Penicilin|"Antibiotic response of M. catarrhalis was tested against antibiotics which included: Penicilin (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).~Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.~Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different (unique) pathogen. Isolates were considered unique based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered unique, and both isolates were retained in the analyses.~Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses."|From Day 0 to Year 2|The analysis was performed on the M. catarrhalis unique isolates from quantitative positive subjects who were included in the ATP cohort.|||Unique isolates of subjects||Full Range|Median
2550274|NCT02838407|Secondary|Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects|"Antibiotic response of M. catarrhalis was susceptible (Sus.), or intermediate (Int.), or resistant (Res.)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.~Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.~For the Unique isolate definition, please refer to the previous outcome description.~Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses."|From Day 0 to Year 2|The analysis was performed on the M. catarrhalis unique isolates from quantitative positive subjects who were included in the ATP cohort.|||Unique isolates of subjects|||Number
2550310|NCT02838134|Secondary|Surgical Conditions|"Surgical rating score, concerning the quality of the surgical field, scored with the surgical rating scale (SRS) A likert scale from 1 to 5. Higher scores represent better outcomes.~= extremely poor conditions~= poor conditions~= acceptable conditions~=good conditions~= optimal conditions"|Day 0: Intraoperative, average of scores up to 240 minutes (assessed each 15 minutes)||||score on a scale||Standard Deviation|Mean
2550333|NCT02836613|Secondary|Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration of CGRP (AUC[0-tlast, CGRP])|Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve from Time Zero to Time T, Where T is the Last Time Point with a Measurable Concentration of CGRP (AUC[0-tlast, CGRP])|Pre dose, 24,48,96,120,168,264,336,504,672,1008,1244,1680,2016,2688, and 3360 hours post dose|All participants who received at least 1 dose of study drug and had evaluable AUC[0-tlast, CGRP] PD data.|||day*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2550275|NCT02838407|Secondary|Descriptive Statistics of the Antimicrobial Susceptibility Response of H.Influenzae for Unique Isolates Among Quantitative Positive Subjects, for Penicilin and Erythromycin|"Antibiotic response of H.ifluenzae was tested against antibiotics which included: Penicilin and Erythromycin (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).~Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.~Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different (unique) pathogen. Isolates were considered unique based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered unique, and both isolates were retained in the analyses.~Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses."|From Day 0 to Year 2|The analysis was performed on the H. influenzae unique isolates from quantitative positive subjects who were included in the ATP cohort.|||Unique isolates of subjects||Full Range|Median
2550276|NCT02838407|Secondary|Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects|"Antibiotic response of H.ifluenzae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015])towards the tested antibiotics which included: Amoxicillin/Clavulanate, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.~Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.~For the Unique isolate definition, please refer to the previous outcomes description.~Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses."|From Day 0 to Year 2|The analysis was performed on the H. influenzae unique isolates from quantitative positive subjects who were included in the ATP cohort.|||Unique isolates of subjects|||Number
2550277|NCT02838407|Secondary|Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response From Quantitative Positive Subjects|"Antibiotic response of S.pneumoniae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Penicilin, Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.~Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.~For the Unique isolate definition, please refer to the previous outcome description.~Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses."|From Day 0 to Year 2|The analysis was performed on the S. pneumoniae unique isolates from quantitative positive subjects who were included in the ATP cohort.|||Unique isolates of subjects|||Number
2550278|NCT02838407|Secondary|Number of H. Influenzae or M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Positive Response Among Qualitative Positive Siubjects for Beta-lactamase|"Antimicrobial response of H. influenzae and M. catarrhalis was tested for Beta-lactamase (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).~Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.~Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different (unique) pathogen. Isolates were considered unique based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered unique, and both isolates were retained in the analyses.~Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses."|From Day 0 to Year 2|The analysis was performed on the H. influenzae and M. catarrhalis unique isolates from qualitative positive subjects who were included in the ATP cohort.|||unique isolates of subjects|||Number
2550279|NCT02838407|Secondary|Descriptive Statistics of the Antimicrobial Susceptibility Response of M. Catarrhalis for Unique Isolates Among Qualitative Positive Subjects, for Penicilin|"Antibiotic response of M. catarrhalis was tested against antibiotics which included: Penicilin.~Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.~Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different (unique) pathogen. Isolates were considered unique based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered unique, and both isolates were retained in the analyses.~Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses."|From Day 0 to Year 2|The analysis was performed on the M. catarrhalis unique isolates from qualitative positive subjects who were included in the ATP cohort.|||unique isolates of subjects||Full Range|Median
2550280|NCT02838407|Secondary|Number of M. Catarrhalis Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects|"Antibiotic response of M. catarrhalis was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.~Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.~For the Unique isolate definition, please refer to the previous outcome description.~Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses."|From Day 0 to Year 2|The analysis was performed on the M. catarrhalis unique isolates from qualitative positive subjects who were included in the ATP cohort.|||unique isolates of subjects|||Number
2550311|NCT02838134|Primary|Total Score of the Quality of Recovery-40 Questionnaire (QoR-40)|The QoR-40 is a validated assessment tool for measuring a patient's self-assessed quality of recovery after surgery. It consists of 40 questions measuring 5 dimensions: patient support, comfort, emotions, physical independence and pain. Each item is rated on a scale of 1 to 5, giving a minimal score of 40 and a maximum score of 200. Higher values represent a better outcome|Day 1: 24 hours after detubation|"Explanation of missing data:~One patient from group A missed one page of the QOR-40 questionnaire on postoperative day 1.~One patient from group B did not complete the questionnaires on postoperative days 1 and 2 because of personal circumstances"|||score on a scale||Standard Deviation|Mean
2550281|NCT02838407|Secondary|Descriptive Statistics of the Antimicrobial Susceptibility Response of H. Influenzae for Unique Isolates Among Qualitative Positive Subjects, for Penicilin and Erythromycin|"Antibiotic response of H. influenzae was tested against antibiotics which included: Penicilin and Erythromycin (following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]).~Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.~Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different (unique) pathogen. Isolates were considered unique based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered unique, and both isolates were retained in the analyses.~Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses."|From Day 0 to Year 2|The analysis was performed on the H. influenzae unique isolates from qualitative positive subjects who were included in the ATP cohort.|||unique isolates of subjects||Full Range|Median
2550282|NCT02838407|Secondary|Number of H. Influenzae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects|"Antibiotic response of H.ifluenzae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Amoxicillin/Clavulanate, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.~Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.~For the Unique isolate definition, please refer to the previous outcomes description.~Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses."|From Day 0 to Year 2|The analysis was performed on the H. influenzae unique isolates from qualitative positive subjects who were included in the ATP cohort.|||unique isolates of subjects|||Number
2550283|NCT02838407|Secondary|Number of S. Pneumoniae Unique Isolates With Antimicrobial Susceptibility Response, Among Qualitative Positive Subjects|"Antibiotic response of S.pneumoniae was susceptible (Sus), or intermediate (Int), or resistant (Res)(following Clinical and Laboratory Standards Institute [CLSI] guidelines [CLSI, 2015]) towards the tested antibiotics which included: Penicilin, Amoxicillin/Clavulanate, Erythromycin, Azithromycin, Tetracycline, Levofloxacin, Trimethoprim/Sulfamethoxazole.~Samples assessed were BAL fluid (BALF) samples and Nasopharyngeal swab (NPS) samples.~For the Unique isolate definition, please refer to the previous outcome description.~Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses."|From Day 0 to Year 2|The analysis was performed on the S. pneumoniae unique isolates from qualitative positive subjects who were included in the ATP cohort.|||unique isolates of subjects|||Number
2550284|NCT02838407|Secondary|Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From Nasopharyngeal Swab Samples|"The H. influenzae typing results include f  and NT (not typeable). Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different (unique) pathogen. Isolates were considered unique based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered unique, and both isolates were retained in the analyses."|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable unique isolates of subjects for H. influenzae, who complied with the protocol and with nasopharyngeal swab sampling results available.|||unique isolates of subjects|||Number
2550285|NCT02838407|Secondary|Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes From Nasopharyngeal Swab Samples|"S. pneumoniae serogoups and serotypes included: 3, 6A, 6B, 7C, 9N, 10A, 11A, 11D, 12B, 12F, 14, 16F, 18C, 18F, 19A, 19C, 19F, 21, 23A, 23B, 31, 35A, 35F, 42, 48, NT (not typeable), Synflorix serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Pneumococcal conjugate vaccine (PCV) 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F).~Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different (unique) pathogen. Isolates were considered unique based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered unique, and both isolates were retained in the analyses."|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable unique isolates of subjects for S. pneumoniae, who complied with the protocol and with nasopharyngeal swab sampling results available.|||unique isolates of subjects|||Number
2550286|NCT02838407|Secondary|Number of Qualitative Positive Unique Isolates of Subjects With H. Influenzae Typing Results From BAL Fluid Samples|"The H. influenzae typing results included f and NT (not typeable). Unique isolate definition: 2 isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different (unique) pathogen. Isolates were considered unique based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered unique, and both isolates were retained in the analyses.~Note: For one subject who underwent BAL procedure, no BALF was available for study analyses."|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable unique isolates of subjects for H. influenzae, who complied with the protocol and with BAL fluid sampling results available.|||unique isolates of subjects|||Number
2550312|NCT02838017|Secondary|Number of Participants Requiring Antibiotic Treatment for Wound Complication|The investigators will review medical records to assess for antibiotic prescriptions for wound complications|Within 8 weeks of delivery||||Participants|||Count of Participants
2550313|NCT02838017|Secondary|Operative Time|The investigators will review operative records to assess operative time|At time of delivery||||min||Inter-Quartile Range|Median
2550314|NCT02838017|Secondary|Number of Participants Who Required an Office or Emergency Department Visit for Wound Complication|The investigators will review medical records to assess for ambulatory visits for wound complaints|Within 8 weeks of delivery||||Participants|||Count of Participants
2550287|NCT02838407|Secondary|Number of Qualitative Positive Unique Isolates of Subjects With S. Pneumoniae Serogroups and Serotypes in BAL Fluid Samples|"Two isolates of S.p., H.i. and M.c. were selected per specimen type per subjects. For analyses, the 2 isolates were compared to determine if they were clones vs. different (unique) pathogen. Isolates were considered unique based on the comparison of serotype and antibiotic susceptibility (AS) profile for S.p. and H.i. and on the AS profile alone for M.c.. If the 2 isolates had different serotypes, or the same serotype but a different AS profile, then the 2 isolates were considered unique, and both isolates were retained in the analyses. S.p. serogoups and serotypes isolates included: 3, 6B, 7C, 10A, 11A, 11D, 12F, 14, 15B, 16F, 18C, 18F, 19A, 19F, 21, 22F, 23A, 23B, 31, 35F, 42, 48, NT (not typeable), Synflorix serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Pneumococcal conjugate vaccine (PCV) 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F). Note: For one subject who underwent BAL procedure, no BALF was available for study analyses."|From Day 0 to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable unique isolates of subjects for S. pneumoniae, who complied with the protocol and with BAL fluid sampling results available.|||unique isolates of subjects|||Number
2550288|NCT02838407|Secondary|Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture From Nasopharyngeal Swab Samples|Bacterial pathogens were detected by qualitative culture from nasopharyngeal swab samples and included: Staphylococcus aureus and Stenotrophomonas maltophilia|From Day 0 and up to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with nasopharyngeal swab sampling results available.|||Participants|||Count of Participants
2550289|NCT02838407|Secondary|Bacterial Load Detected (log10 Transformation) by Molecular Techniques (PCR) From Nasopharyngeal Swab Samples|Bacterial load was detected by quantitative molecular techniques from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load >10^4 cfu/mL if present alone or > 10^5 cfu/mL if present as co-infection.|From Day 0 and up to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with nasopharyngeal swab sampling results available for the outcome measure.|||cfu/mL||Standard Deviation|Mean
2550290|NCT02838407|Secondary|Bacterial Load Detected (log10 Transformation) by Quantitative Culture From Nasopharyngeal Swab Samples|Bacterial load was detected by quantitative culture from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/ milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load >10^4 cfu/mL if present alone or > 10^5 cfu/mL if present as co-infection.|From Day 0 up to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with nasopharyngeal swab sampling results available for the outcome measure.|||cfu/mL||Standard Deviation|Mean
2550291|NCT02838407|Secondary|Number of Subjects With Other Bacterial Pathogens Detected by Qualitative Culture, From BAL Fluid Samples|"Bacterial pathogens were detected by qualitative culture from BAL fluid samples and included:~Staphylococcus aureus, Pseudomonas aeruginosa, Stenotrophomonas maltophilia and Pseudomonas putida.~Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses."|From Day 0 up to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling results available.|||Participants|||Count of Participants
2550292|NCT02838407|Secondary|Bacterial Load Detected (log10 Transformation) by Quantitative Molecular Techniques (Polymerase Chain Reaction) From BAL Fluid Samples|"Bacterial load was detected by quantitative molecular techniques (PCR) from BAL fluid samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load >10^4 cfu/mL if present alone or > 10^5 cfu/mL if present as co-infection.~Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses."|From Day 0 up to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling results available for the outcome measure.|||cfu/mL||Standard Deviation|Mean
2550293|NCT02838407|Secondary|Bacterial Load Detected (log10 Transformation) by Quantitative Culture Growth, From BAL Fluid Samples|Bacterial load was detected by quantitative culture growth from BAL fluid samples for S. pneumoniae, H. influenzae and M. catarrhalis and expressed in colony-forming unit/ milliliter (cfu/mL). Quantitative bacterial identification was used to indicate the presence of bacterial pathogen load >10^4 cfu/mL if present alone or > 10^5 cfu/mL if present as co-infection. Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses.|From Day 0 up to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling results available for the outcome measure.|||cfu/mL||Standard Deviation|Mean
2550294|NCT02838407|Secondary|Number of Subjects With Bacterial Colonization, Assessed by Culture Growth, From Nasopharyngeal Swab Samples|Bacterial colonization was assessed by culture growth from nasopharyngeal swab samples for S. pneumoniae, H. influenzae and M. catarrhalis, through either qualitative or quantitative bacterial identification (B.I.). The categories assessed were: positive (Pos.) and negative (Neg.).|From Day 0 up to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with nasopharyngeal swab sampling results available.|||Participants|||Count of Participants
2550315|NCT02838017|Secondary|Satisfaction With Cesarean Scar|"The investigators will be using a modified validated Patient Scar Assessment Scale (PSAS) which assessed scar-related pain, itchiness, color, stiffness, irregularity and overall satisfaction with the scar. Each item on the PSAS has a 10-point scale, with 10 indicating the highest symptom severity or lowest satisfaction. The median score for each item was compared between groups.~Please see website in links section for more details on this assessment tool."|6-8 weeks from cesarean delivery|Completion of the modified Patient Scar Assessment Scale was accomplished in 203/252 (80.6%) of women in the tissue adhesive group and 203/252 (80.6%) of women in the sterile strips group.|||score on a scale||Inter-Quartile Range|Median
2550316|NCT02838017|Secondary|Number of Participants With Readmission for Wound Complication||Within 8 weeks from cesarean delivery||||Participants|||Count of Participants
2550295|NCT02838407|Primary|"Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the Positive M. Catarrhalis BAL Fluid Samples Results Category)"|"S. pneumoniae, H. influenzae and M. catarrhalis were confirmed by bacterial identification load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone and by bacterial load >10^5 cfu/mL if presented as co-infection.~Categories referred to Positive M. catarrhalis -Negative S. pneumoniae - Negative H. influenzae (P.M.c.-N.S.p.-N.H.i.), Positive M. catarrhalis -Negative S. pneumoniae - Positive H. influenzae (P.M.c.-N.S.p.-P.H.i.), Positive M. catarrhalis - Positive S. pneumoniae - Negative H. influenzae (P.M.c.-P.S.p.-N.H.i.), Positive M. catarrhalis - Positive S. pneumoniae - Positive H. influenzae (P.M.c.-P.S.p.-P.H.i.). Notes: bacterial identification for the P.M.c.-N.S.p.-P.H.i., P.M.c.-P.S.p.-N.H.i. and P.M.c.-P.S.p.-P.H.i. categories was confirmed by a bacterial identification >10^5 cfu/mL. For one subject who underwent BAL procedure, no BAL fluid was available for study analyses"|From Day 0 up to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with positive M.catarrhalis BAL Fluid samples results available.|||Participants|||Count of Participants
2550296|NCT02838407|Primary|"Number of Subjects With Bacterial Identification >10^4 Cfu/mL in BAL Fluid Samples (S. Pneumoniae and H. Influenzae Results for the Negative M. Catarrhalis BAL Fluid Samples Results Category)"|"S. pneumoniae, H. influenzae and M. catarrhalis were confirmed by bacterial identification load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone. Bacterial load referred to Negative M. catarrhalis - Negative S. pneumoniae - Negative H. influenzae (N.M.c.-N.S.p.-N.H.i.), Negative M. catarrhalis - Negative S. pneumoniae - Positive H. influenzae (N.M.c.-N.S.p.-P.H.i.), Negative M. catarrhalis - Positive S. pneumoniae - Negative H. influenzae (N.M.c.-P.S.p.-N.H.i.), Negative M. catarrhalis - Positive S. pneumoniae - Positive H. influenzae (N.M.c.-P.S.p.-P..H.i.).~Notes: bacterial identification for the N.M.c.-P.S.p.-P.H.i. category was confirmed as a co-infection with a bacterial load >10^5 cfu/mL. For one subject who underwent BAL procedure, no BAL fluid was available for study analyses."|From Day 0 up to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with negative M.catarrhalis BAL Fluid samples results available.|||Participants|||Count of Participants
2550297|NCT02838407|Primary|Number of Subjects With Bacterial Aetiology Characteristics in BAL Fluid Samples|"S. pneumoniae (S.p.), H. influenzae (H.i.) and M. catarrhalis (M.c.) were confirmed by bacterial identification (B.I.) load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone, or >10^5 cfu/mL if presented as co-infection. Analysis was also performed for other bacterial pathogens alone or as co-infection.~Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses"|From Day 0 up to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling results available.|||Participants|||Count of Participants
2550298|NCT02838407|Primary|Number of Subjects With Bacterial Aetiology, Assessed by Culture Growth, From Bronchoalveolar Lavage (BAL) Fluid Samples|"Bacterial aetiology was assessed by culture growth from BAL fluid sample for Steptococcus pneumoniae (S.p.), Haemophilus influenzae (H.i.) and Moraxella catarrhalis (M.c.) , through either qualitative or quantitative bacterial identification (B.I.). The categories assessed were: positive (Pos.), negative (Neg.) and Missing (Mis.). For quantitative bacterial identification, S.p., H.i. and M.c. were confirmed by bacterial identification load higher than (>) 10^4 colony forming units per milliliter (cfu/mL), if bacterial species were present alone, or >10^5 cfu/mL if present as co-infection.~Note: For one subject who underwent BAL procedure, no BAL fluid was available for study analyses."|From Day 0 up to Year 2|The analysis was performed on the According to protocol (ATP) cohort, which included all evaluable subjects, who complied with the protocol and with BAL fluid sampling results available.|||Participants|||Count of Participants
2550299|NCT02838134|Secondary|Pain Scores|Total amount of pain 4 weeks after surgery Likert scale from 0 to 10. Higher scores represent more pain (worse outcome).|once, 4 weeks after surgery||||score on a scale||Standard Deviation|Mean
2550300|NCT02838134|Secondary|Discharge Criteria|Scoring the following criteria: adequate pain control with oral medication, passage of flatus or defecation, intake of solid food tolerated, patient is mobilized and independent and patient accepts discharge.|24 and 48 hours after detubation||||Participants|||Count of Participants
2550301|NCT02838134|Secondary|Postoperative Complications|Number of participants with postoperative complications that occurred up to 8 weeks after surgery|24 and 48 hours (and if still admitted 72h) after detubation and 4 and 8 weeks after surgery||||Participants|||Count of Participants
2550302|NCT02838134|Secondary|Postoperative Pain|"components of pain scores after 1 hour, 6 hours, on postoperative day 1 (POD1) and postoperative day 2 (POD2).~Likert scale from 0 to 10. Higher scores represent more pain."|Day 0: 1h, 6h, day 1: 24h and day 2: 48 hours (and if still admitted 72h) after detubation|1 patient from the moderate NMB group was not able to complete the questionnaires on day 1 and day 2 because of personal circumstances.|||score on a scale||Standard Deviation|Mean
2550303|NCT02838134|Secondary|Total Score of the Quality of Recovery-40 Questionnaire|The QoR-40 is a validated assessment tool for measuring a patient's self-assessed quality of recovery after surgery. It consists of 40 questions measuring 5 dimensions: patient support, comfort, emotions, physical independence and pain. Each item is rated on a scale of 1 to 5, giving a minimal score of 40 and a maximum score of 200. Higher values represent a better outcome.|Day 2: 48 hours after detubation||||score on a scale||Standard Deviation|Mean
2550304|NCT02838134|Secondary|Cumulative Use of Rocuronium|Total amount of rocuronium administered during surgery|Day 0: once, up to 240 minutes||||mg||Standard Deviation|Mean
2550305|NCT02838134|Secondary|Intra-operative Complications|Number of Participants with Complications which occurred during surgery|Day 0: once, up to 240 minutes||||Participants|||Count of Participants
2550306|NCT02838134|Secondary|Conversion|Number of Participants with conversion to open or hand-assisted donor nephrectomy|Day 0: once, up to 240 minutes||||Participants|||Count of Participants
2550307|NCT02838134|Secondary|Estimated Blood Loss|Intraoperative parameter|Day 0: once, up to 240 minutes||||ml||Standard Deviation|Mean
2550308|NCT02838134|Secondary|Warm Ischemia Time|Intraoperative parameter measuring the time (in minutes) between dissection of the renal artery and flushing of the kidney after retrieval|Day 0: once, up to 240 minutes||||minutes||Standard Deviation|Mean
2550318|NCT02837952|Secondary|"Time to Onset of Meaningful Pain Relief After First Dose"|"Using the double stopwatch method, participants started two stopwatches soon after dosing. Participants evaluated time to meaningful relief after first dose by stopping the second stopwatch labelled as meaningful relief at the moment they first began to experience meaningful relief after the administration of first dose and prior to the administration of second dose of study drug. The stopwatch was active for up to 8 hours after dosing or until stopped by the participant, or until second dose or a rescue medication whichever is administered first."|Up to 8 hours after first dose|The FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||minutes||95% Confidence Interval|Median
2550319|NCT02837952|Secondary|Duration of Relief After First Dose|Duration of relief (in minutes) was defined as the time interval from the administration of first dose of study drug up to the administration of a rescue medication or discontinuation of the participant from the study due to lack of efficacy or administration of second dose of study drug, whichever occurred first. If prior to taking rescue medication or secondary dose, a participant discontinued early from the study due to other reasons, the time was censored at time when the participant last performed a study evaluation prior to the discontinuation.|Up to 8 hours after first dose|The FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||minutes||95% Confidence Interval|Median
2550320|NCT02837952|Secondary|Time-weighted Sum of Pain Intensity Difference Score on 11-Point Numerical Scale (SPID11) From 0 to 8, 6 to 8, 0 to 16, 8 to 16 and 0 to 48 Hours Post-dose|Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 for various time intervals: Time-weighted sum of PID scores over time intervals of 0-8 hours, 6-8 hours, 0-16 hours, 8-16 hours and 0-48 hours. SPID11 score range was -40 (worst score) to 80 (best score) for (SPID11 [0-8]), -15 (worst score) to 30 (best score) for (SPID11 [6-8]), -80 (worst score) to 160 (best score) for (SPID11 [0-16]), -45 (worst score) to 90 (best score) for (SPID11 [8-16]), -240 (worst score) to 480 (best score) for (SPID11 [0-48]). PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).|0 to 8 hours, 6 to 8 hours, 0 to 16 hours, 8 to 16 hours and 0 to 48 hours post dose|The FAS included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2550321|NCT02837952|Primary|Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 24 Hours Post-dose (SPID11 [0-24])|Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 [0-24]: Time-weighted sum of Pain Intensity Difference (PID) scores over 24 hours. SPID11 score range was -120 (worst score) to 240 (best score) for SPID 0-24. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).|0 to 24 hours post dose|The full analysis set (FAS) included all randomized participants who were dosed with the study medication and provided a baseline assessment.|||units on a Scale||Standard Error|Least Squares Mean
2550322|NCT02837913|Secondary|Vitals: Blood Pressure|Vitals: blood pressure as mean arterial pressure|Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals|healthy women undergoing cesarean|||mmHg||Standard Deviation|Mean
2550323|NCT02837913|Secondary|Vitals: Oxygen Saturation|Vitals: Oxygen Saturation from preoperative through end post anesthesia recovery unit|Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals|healthy women undergoing cesarean|||oxygen saturation, %||Standard Deviation|Mean
2550324|NCT02837913|Secondary|Thermal Comfort Visual Analog Scale|Thermal comfort visual analog scale with scores 0-100 with 50 being temperature comfort/neutral, 100 being hottest, 0 being cold|Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals|health women undergoing cesarean|||units on a scale||Standard Deviation|Mean
2550325|NCT02837913|Secondary|Time to Neonatal Bonding|time to neonatal bonding as skin to skin|time from delivery to first maternal contact during the 2 hour surgical procedure|healthy women undergoing cesarean|||minutes||Standard Deviation|Mean
2550326|NCT02837913|Secondary|Blood Loss|Estimated blood loss with and without warming|Documented at the end of 2 hour surgical procedure|healthy pregnant women undergoing cesarean|||milliliter||Standard Deviation|Mean
2550327|NCT02837913|Secondary|Vitals: Heart Rate|Vitals: Heart Rate from preoperative through end of post anesthesia recovery unit|Preop up to 45 minutes after admission Post Anesthesia Care Unit, 15 min intervals|healthy women undergoing cesarean|||beats per minutes||Standard Deviation|Mean
2550328|NCT02837913|Secondary|Number of Participants With Shivering|Shivering at time of post anesthesia care unit admission|15 minute intervals until no shivering, up to 45 minutes after admission Post Anesthesia Care Unit||||Participants|||Count of Participants
2550329|NCT02837913|Primary|Temperature|Temperature at time of post anesthesia care unit admission|15 minute intervals until normothermic, up to 45 minutes after admission Post Anesthesia Care Unit||||Degrees Fahrenheit||Standard Deviation|Mean
2550330|NCT02837328|Secondary|Change in Magnesium Concentration|The secondary endpoint will be the change in circulating magnesium between baseline and a follow-up visit 10 weeks later.|Baseline and week 10||||mEq/L||Standard Deviation|Mean
2550331|NCT02837328|Primary|Change in Premature Atrial Contractions (PACs)|The primary endpoint will be the change in burden of PACs|Change from Baseline at 10 weeks||||Episodes/hour||Standard Deviation|Mean
2550332|NCT02837237|Primary|Number of Participants With Treatment-related Adverse Events|Physical exam, vital signs, EKG, clinical laboratory tests, adverse events|312 hours||||Participants|||Count of Participants
2550334|NCT02836613|Secondary|Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax)|Pharmacodynamics (PD): Maximum Observed CGRP Concentration (Cmax)|Pre dose, 24,48,96,120,168,264,336,504,672,1008,1244,1680,2016,2688, and 3360 hours post dose|All participants who received at least 1 dose of study drug and had evaluable Cmax CGRP PD data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2550335|NCT02836613|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf] of Galcanezumab|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf] of Galcanezumab|8, 24, 48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688 and 3360 hours post dose|All participants who received at least 1 dose of study drug and had evaluable PK data.|||day*ug/mL||Geometric Coefficient of Variation|Geometric Mean
2550336|NCT02836613|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galcanezumab|8, 24, 48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688 and 3360 hours post dose|All participants who received at least 1 dose of study drug and had evaluable PK data.|||micrograms per milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2550337|NCT02836496|Secondary|Number of Participants With Change From Baseline in Fatigue Severity Based on Brief Fatigue Inventory (BFI) in Item 3 (Worst Level of Fatigue During Past 24 Hours) at Week 32 by Category|"The change from Baseline in fatigue severity (worst level of fatigue during past 24 hours) at Week 32 was calculated using the mean of the 7 daily assessments of BFI item 3 up to and including the date of the Week 32 visit as the Week 32 assessment, and the mean of the 7 daily assessments of BFI item 3 up to but not including the date of first dose of study treatment as the Baseline assessment. Wilcoxon Rank Sum test stratified by Baseline fatigue severity (severe defined as BFI item 3>=7 and not severe defined as BFI item 3<7), Baseline OCS (0-<=20mg/day and >20mg/day prednisone or equivalent) and region. Participants with missing change from Baseline at Week 32 were included in the worst category (>=4 point increase)."|Baseline (Week 0) and at Week 32|ITT Population.|||Participants|||Count of Participants
2550338|NCT02836496|Secondary|Number of HES Flares Per Participant Per Year|The rate of HES flares for each participant was calculated as the number of observed HES flares divided by the time (expressed in years) between randomization and either the week 32 visit date if available, or the study withdrawal date. Negative binomial generalized linear model including Baseline OCS dose, region, treatment and observed time (offset variable). Wilcoxon test stratified by Baseline OCS (0-<=20mg/day, >20mg/day prednisone or equivalent) and region. Adjusted mean and 95% CI rate/year has been presented.|Up to Week 32|ITT Population.|||Flares per participant per year||95% Confidence Interval|Mean
2550339|NCT02836496|Secondary|Time to First HES Flare|The time to first HES flare was calculated as (onset date of first HES flare minus date of first dose of study treatment) plus 1. Probability of first flare (by week 4, 8, 12, 16, 20, 24, 28, and 32) and corresponding 95% CI have been presented, calculated using the Kaplan-Meier method.|Weeks 4, 8, 12, 16, 20, 24, 28 and 32|ITT Population.|||Probability expressed as percentage||95% Confidence Interval|Number
2550340|NCT02836496|Secondary|Percentage of Participants Who Experienced a HES Flare or Who Withdrew From the Study During Week 20 Through Week 32|HES flare during Week 20 through Week 32 was defined as a HES flare starting or ongoing on or after the date of the Week 20 visit up to and including the date of the Week 32 visit. Percentage of participants who experienced >=1 HES flare during Week 20 through Week 32 or who withdrew from the study has been presented.|Week 20 to Week 32|ITT Population.|||Percentage of participants|||Number
2550341|NCT02836496|Primary|Percentage of Participants Who Experienced an HES Flare or Who Withdrew From the Study During the 32-Week Study Treatment Period|Percentage of participants who experienced >=1 HES flare during the 32-Week treatment period or who withdrew from the study has been presented. A HES flare is defined as a HES related clinical manifestation based on a physician-documented change in clinical signs or symptoms which resulted in need for an increase in the maintenance Oral Corticosteroid (OCS) dose by at least 10 mg per day for 5 days or an increase in or addition of any cytotoxic or immunosuppressive HES therapy. HES flare is also defined as receipt of two or more courses of blinded active OCS during the treatment period. Intent-to-treat (ITT) Population comprises of all randomized participants. This population was based on the treatment to which the participants were randomized. Any participant who received a treatment randomization number were considered to be randomized.|Up to Week 32|ITT Population.|||Percentage of participants|||Number
2550342|NCT02836249|Other Pre-specified|Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method.|Up to 48 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.|||percentage of participants|||Number
2550343|NCT02836249|Secondary|Change From Baseline at Week 48 in Serum Creatinine||Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.|||mg/dL||Standard Deviation|Mean
2550344|NCT02836249|Secondary|Percent Change From Baseline in Spine BMD at Week 48||Baseline; Week 48|Participants in the Spine DXA Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline spine BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.|||percent change||Standard Deviation|Mean
2550345|NCT02836249|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48||Baseline; Week 48|Participants in the Hip Dual-Energy X-ray Absorptiometry (DXA) Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline hip BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.|||percent change||Standard Deviation|Mean
2550346|NCT02836249|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48||Week 48|Serologically Evaluable Full Analysis Set: participants who were randomized, had received at least 1 dose of study drug, and were HBeAg positive and anti-HBe negative or had a value missing value at baseline. Participants were analyzed according to their randomized treatment group. All missing data were treated as no HBeAg seroconversion.|||percentage of participants|||Number
2550347|NCT02836249|Primary|Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48||Week 48|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drugs. Participants were analyzed according to the treatment to which they were randomized.|||percentage of participants|||Number
2550348|NCT02836236|Other Pre-specified|Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method.|Up to 48 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.|||percentage of participants|||Number
2550349|NCT02836236|Secondary|Change From Baseline in Serum Creatinine at Week 48||Baseline; Week 48|"Participants in the Safety Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received.~Missing data were excluded from analysis."|||mg/dL||Standard Deviation|Mean
2550350|NCT02836236|Secondary|Percent Change From Baseline in Spine BMD at Week 48||Baseline; Week 48|Participants in the Spine DXA Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline spine BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.|||percent change||Standard Deviation|Mean
2550351|NCT02836236|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48||Baseline; Week 48|Participants in the Hip Dual-Energy X-ray Absorptiometry (DXA) Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline hip BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.|||percent change||Standard Deviation|Mean
2550352|NCT02836236|Primary|Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48||Week 48|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drugs. Participants were analyzed according to the treatment to which they were randomized.|||percentage of participants|||Number
2550353|NCT02835820|Secondary|Neural Activity: Presence or Absence of Impaired Bloodflow in the Brain at 12 Weeks Post Baseline as Determined by a Functional MRI|Functional MRI is used to determine blood flow in the brain. Absence of blood flow impairment will be recorded as '0' and impairment will be recorded as '1'|Baseline to 12 weeks|Intervention group as randomized.|||Participants|||Count of Participants
2550354|NCT02835820|Secondary|Neural Activity: Presence or Absence of Impaired Bloodflow in the Brain at Baseline as Determined by a Functional MRI|Functional MRI is used to determine blood flow in the brain. Absence of blood flow impairment will be recorded as '0' and impairment will be recorded as '1'|baseline|Those randomized to intervention group at baseline without MRI contraindications|||Participants|||Count of Participants
2550355|NCT02835820|Primary|Tumor Necrosis Factor (TNF or TNF-α)|Tumor Necrosis Factor Alpha (TNF or TNF-α) is a major pro-inflammatory cytokine involved in inflammatory events. Being one of the most important pro-inflammatory cytokines, TNF-α participates in vasodilatation and edema formation, and leukocyte adhesion to epithelium through expression of adhesion molecules; it regulates blood coagulation, and also contributes to oxidative stress in sites of inflammation.|baseline to week 12||||pg/mL||Standard Deviation|Mean
2550356|NCT02835820|Primary|Tumor Necrosis Factor Alpha (TNF or TNF-α)|Tumor Necrosis Factor Alpha (TNF or TNF-α) is a major pro-inflammatory cytokine involved in inflammatory events. Being one of the most important pro-inflammatory cytokines, TNF-α participates in vasodilatation and edema formation, and leukocyte adhesion to epithelium through expression of adhesion molecules; it regulates blood coagulation, and also contributes to oxidative stress in sites of inflammation.|baseline|Three PCD participants were ineligible due to baseline screen fail.|||pg/mL||Standard Deviation|Mean
2550357|NCT02835820|Primary|Cardiometabolic Markers: Mean Markers of Inflammation (C-reactive Protein) Measures at 12 Weeks Post Baseline|C-reactive protein (CRP) , a protein in the blood, indicates inflammation, specifically in the heart.. CRP levels rise with inflammation. A CRP concentration of below 1.0 mg/L indicates low risk; 1.0 to 3.0 mg/L suggests an average risk. Greater than 3.0 mg/L suggests a high risk.|baseline to 12 weeks|Three PCD participants were ineligible due to baseline screen fail.|||mg/L||Standard Deviation|Mean
2550358|NCT02835820|Primary|Cardiometabolic Markers: Mean Markers of Inflammation (C-reactive Protein) Measures at Baseline|C-reactive protein (CRP) , a protein in the blood, indicates inflammation, specifically in the heart.. CRP levels rise with inflammation. A CRP concentration of below 1.0 mg/L indicates low risk; 1.0 to 3.0 mg/L suggests an average risk. Greater than 3.0 mg/L suggests a high risk.|baseline|Three PCD participants were ineligible due to baseline screen fail.|||mg/L||Standard Deviation|Mean
2550359|NCT02835820|Primary|Cardiometabolic Markers: Mean Fasting Glucose Measures at 12 Weeks Post Baseline|A fasting blood sugar level less than 100mg/dl is normal. A fasting blood sugar level of 100- 126mg/dl is considered prediabetic. 126mg/dl or greater suggests diabetes|baseline to 12 weeks|Three PCD participants were ineligible due to baseline screen fail.|||mg/dL||Standard Deviation|Mean
2550360|NCT02835820|Primary|Cardiometabolic Markers: Mean Fasting Glucose Measures at Baseline|A fasting blood sugar level less than 100mg/dl is normal. A fasting blood sugar level of 100- 126mg/dl is considered prediabetic. 126mg/dl or greater suggests diabetes|baseline|Three PCD participants were ineligible due to baseline screen fail.|||mg/dL||Standard Deviation|Mean
2550361|NCT02835820|Primary|Neurocognition: Mean Score of Stroop Test at 18 Weeks Post Baseline|"The STROOP measures brain damage. The score of greater than is considered normal; a score of 40 or less is considered low whereas a score greater than 40 is considered normal.~Stroop test is named after the instrument developer, John Stroop. The instrument title is not an acronym."|baseline to 18 weeks|Three PCD participants ineligible due to baseline screen fail.|||Number of correctly identified items||Standard Deviation|Mean
2550362|NCT02835820|Primary|Neurocognition: Mean Score of Stroop Test at 12 Weeks Post Baseline|"The score of greater than is considered normal; a score of 40 or less is considered low whereas a score greater than 40 is considered normal.~Stroop test is named after the instrument developer, John Stroop. The instrument title is not an acronym."|Baseline to 12 weeks|Three PCD participants ineligible due to baseline screen fail.|||Number of correctly identified items||Standard Deviation|Mean
2550363|NCT02835820|Primary|Neurocognition: Mean Score of Stroop Test at Baseline|"The score of greater than is considered normal; a score of 40 or less is considered low whereas a score greater than 40 is considered normal.~Stroop test is named after the instrument developer, John Stroop. The instrument title is not an acronym."|baseline|Three PCD participants ineligible due to baseline screen fail.|||Number of correctly identified items||Standard Deviation|Mean
2550364|NCT02835820|Primary|Neurocognition: Mean Score of Trail Making A and B at 18 Weeks Post Baseline|Trails A (simple) and Trails B (alternative) neuropsychological assessments provide information on cognitive processes such as visual search, scanning, speed of processing, mental flexibility, and executive functions (i.e., memory, problem solving, verbal reasoning). It is sensitive to cognitive impairment associated with dementia. The average score for trail making is 29 seconds. Scores over 78 seconds suggest a deficit.|baseline to 18 weeks|Three PCD participants ineligible due to baseline screen fail.|||Seconds to complete||Standard Deviation|Mean
2550365|NCT02835820|Primary|Neurocognition: Mean Score of Trail Making A and B at 12 Weeks Post Baseline|Trails A (simple) and Trails B (alternative) neuropsychological assessments provide information on cognitive processes such as visual search, scanning, speed of processing, mental flexibility, and executive functions (i.e., memory, problem solving, verbal reasoning).It is sensitive to cognitive impairment associated with dementia. The average score for trail making is 29 seconds. Scores over 78 seconds suggest a deficit.|baseline to 12 weeks|Three PCD participants ineligible due to baseline screen fail.|||Seconds to complete||Standard Deviation|Mean
2550366|NCT02835820|Primary|Neurocognition: Mean Score of Trail Making A and B at Baseline|Trails A (simple) and Trails B (alternative) neuropsychological assessments provide information on cognitive processes such as visual search, scanning, speed of processing, mental flexibility, and executive functions (i.e., memory, problem solving, verbal reasoning). It is sensitive to cognitive impairment associated with dementia. The average score for trail making is 29 seconds. Scores over 78 seconds suggest a deficit.|baseline|Three PCD participants ineligible due to baseline screen fail.|||Seconds to complete||Standard Deviation|Mean
2550367|NCT02835820|Primary|Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at 18 Weeks Post Baseline|The Wechsler Adult Intelligence Scale is an I! test to measure intelligence and cognitive ability. The Full Scale scores are: beyond 130 place an individual in the superior or gifted range; scores between 120-129 suggest very bright; scores between 110-119 are bright normal; scores as 90-109 are average; scores of 85-89 suggest average intelligence; score of 70-84 suggests low average intelligence; score of 50 - 69 suggests borderline mental functioning; score of 50 - 69 suggests mild mental retardation; score of 35-49 suggests moderate retardation; 20 - 34 suggests severe retardation; below 20 - 25 suggests profound retardation|baseline to 18 weeks|Three PCD participants ineligible due to baseline screen fail.|||score on a scale||Standard Deviation|Mean
2550368|NCT02835820|Primary|Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at 12 Weeks Post Baseline|The Wechsler Adult Intelligence Scale is an I! test to measure intelligence and cognitive ability. The Full Scale scores are: beyond 130 place an individual in the superior or gifted range; scores between 120-129 suggest very bright; scores between 110-119 are bright normal; scores as 90-109 are average; scores of 85-89 suggest average intelligence; score of 70-84 suggests low average intelligence; score of 50 - 69 suggests borderline mental functioning; score of 50 - 69 suggests mild mental retardation; score of 35-49 suggests moderate retardation; 20 - 34 suggests severe retardation; below 20 - 25 suggests profound retardation|baseline to 12 weeks|Three PCD participants ineligible due to baseline screen fail.|||score on a scale||Standard Deviation|Mean
2550369|NCT02835820|Primary|Neurocognition: Mean Score of Wechsler Adult Intelligence Scale at Baseline|The Wechsler Adult Intelligence Scale is an II test to measure intelligence and cognitive ability. The Full Scale scores are: beyond 130 place an individual in the superior or gifted range; scores between 120-129 suggest very bright; scores between 110-119 are bright normal; scores as 90-109 are average; scores of 85-89 suggest average intelligence; score of 70-84 suggests low average intelligence; score of 50 - 69 suggests borderline mental functioning; score of 50 - 69 suggests mild mental retardation; score of 35-49 suggests moderate retardation; 20 - 34 suggests severe retardation; below 20 - 25 suggests profound retardation|baseline|Three PCD participants ineligible due to baseline screen fail.|||score on a scale||Standard Deviation|Mean
2550370|NCT02835820|Primary|Neurocognition: Mean Score of Hopkins Verbal Learning Test at 18 Weeks Post Baseline|The Hopkins Verbal Learning Test is used to measure episodic verbal learning and memory. The range of the score for the Hopkins Verbal Learning score is as follows: > 130 superior; 120-129 high; 110-119 bright, normal; 90-109 average; 85-89 low average; 70-84 borderline mental deficit; 35-49 moderate mental deficit; 20-34 severe mental deficit; 20-25 profound mental deficit.|baseline to week 18|Three PCD participants ineligible due to baseline screen fail.|||score on a scale||Standard Deviation|Mean
2550371|NCT02835820|Primary|Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at 12 Weeks Post Baseline|The Hopkins Verbal Learning Test is used to measure episodic verbal learning and memory. The range of the score for the Hopkins Verbal Learning score is as follows: > 130 superior; 120-129 high; 110-119 bright, normal; 90-109 average; 85-89 low average; 70-84 borderline mental deficit; 35-49 moderate mental deficit; 20-34 severe mental deficit; 20-25 profound mental deficit.|baseline to week 12|Three PCD participants ineligible due to baseline screen fail.|||score on a scale||Standard Deviation|Mean
2550372|NCT02835820|Primary|Neurocognition: Mean Score of Hopkins Verbal Learning Test (Total) at Baseline|The Hopkins Verbal Learning Test is used to measure episodic verbal learning and memory. The range of the score for the Hopkins Verbal Learning score is as follows: > 130 superior; 120-129 high; 110-119 bright, normal; 90-109 average; 85-89 low average; 70-84 borderline mental deficit; 35-49 moderate mental deficit; 20-34 severe mental deficit; 20-25 profound mental deficit.|baseline|Three participants from the PCD ineligible due to baseline screen fail.|||score on a scale||Standard Deviation|Mean
2550373|NCT02835690|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was reported for each arm using a 19-Sept-2017 data cut-off date.|Up to ~13 months (through database cut-off date of 19-Sept-2017)|All randomized participants that received at least one dose of study treatment.|||Months||95% Confidence Interval|Median
2550374|NCT02835690|Secondary|PFS Per irRECIST as Assessed by Central Radiologists' Review|PFS was defined as the time from randomization to the first documented immune-based confirmed progressive disease (iCPD) or death due to any cause, whichever occurred first. Per iRECIST, iCPD is defined as worsening of any existing cause of progression, or the appearance of any other cause of progression, relative to the initial appearance of progressive disease by RECIST 1.1. PFS per irRECIST as assessed by central radiologists' review is reported for each arm.|Up to ~13 months (through database cut-off date of 19-Sept-2017)|All randomized participants that received at least one dose of study treatment.|||Months||95% Confidence Interval|Median
2550375|NCT02835690|Secondary|Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by Central Radiologists' Review|PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as either a 20% increase from nadir in target lesions, unequivocal progression of nontarget lesions, or the appearance of new lesions. PFS per RECIST 1.1 as assessed by central radiologists' review was reported for each arm.|Up to ~13 months (through database cut-off date of 19-Sept-2017)|All randomized participants that received at least one dose of study treatment.|||Months||95% Confidence Interval|Median
2550376|NCT02835690|Secondary|DOR Per irRECIST as Assessed by Central Radiologists' Review|For participants who demonstrated a confirmed CR (disappearance of all target lesions and non-target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 or CR or PR after a single PD, DOR was defined as the time from the first documented CR or PR, or irCR or irPR, until an immune-related progressive disease (irPD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per irRECIST, irPD was defined as after a single PD, ≥20% increase in the sum of diameters of target lesions, or unequivocal worsening of non-target lesions or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The DOR per irRECIST as assessed by central radiologists' review for all participants who experienced a confirmed CR or PR or irCR or irPR was reported for each arm.|Up to ~13 months (through database cut-off date of 19-Sept-2017)|All randomized participants that received at least one dose of study treatment, had measurable disease at baseline as assessed by central radiology review, and who demonstrated a confirmed response (iCR or iPR). No participants in the Pembrolizumab 2 mg/kg group had a CR or PR and thus were not included in this analysis.|||Months||Full Range|Median
2550377|NCT02835690|Secondary|Duration of Response (DOR) Per RECIST 1.1 as Assessed by Central Radiologists' Review|For participants who demonstrated a confirmed CR (disappearance of all lesions) or confirmed PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by central radiologists' review, DOR was defined as the time from first documented evidence of a CR or PR until disease progression or death. RECIST 1.1 has been modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The DOR per RECIST 1.1 as assessed by central radiologists' review for all participants who experienced a confirmed CR or PR was reported for each arm.|Up to ~13 months (through database cut-off date of 19-Sept-2017)|All randomized participants that received at least one dose of study treatment, had measurable disease at baseline as assessed by central radiology review, and who demonstrated a confirmed response (CR or PR). No participants in the Pembrolizumab 2 mg/kg group had a CR or PR and thus were not included in this analysis.|||Months||Full Range|Median
2550378|NCT02835690|Secondary|ORR Per Immune-related RECIST (irRECIST) as Assessed by Central Radiologists' Review|ORR was defined as the percentage of participants who had confirmed responses assessed using RECIST 1.1 before PD or an immune-related Complete Response (irCR: Disappearance of all target lesions and non-target) or an immune-related Partial Response (irPR: At least a 30% decrease in the sum of diameters of target lesions, stability of non-target lesions no new lesions) after a single PD per irRECIST as assessed by central radiologists' review. Per RECIST 1.1, CR or PR was confirmed by repeated radiographic assessment no less than 4 weeks from the first documented response. If site-assessed PD was verified by the central imaging vendor, the site could elect to continue treatment, repeat imaging ≥4 weeks later and assess tumor response or confirmed progression per irRECIST. The percentage of participants who experienced a CR or PR per RECIST 1.1 or irCR or irPR per irRECIST as assessed by central radiologists' review was reported for each arm.|Up to ~13 months (through database cut-off date of 19-Sept-2017)|All randomized participants that received at least one dose of study treatment and with measurable disease at baseline as assessed by central radiology review.|||Percentage of participants||95% Confidence Interval|Number
2550379|NCT02835690|Secondary|Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Central Radiologists' Review|ORR was defined as the percentage of participants who had a Complete Response (CR: disappearance of all lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions, without evidence of progression based on non-target or new lesions) as assessed by central radiologists' review per RECIST 1.1 which is modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a confirmed CR or PR per RECIST 1.1 as assessed by central radiologists' review was reported for each arm.|Up to ~13 months (through database cut-off date of 19-Sept-2017)|All randomized participants that received at least one dose of study treatment and with measurable disease at baseline as assessed by central radiology review.|||Percentage of participants||95% Confidence Interval|Number
2550380|NCT02835690|Primary|Multiple Dose PK: Cmax of Pembrolizumab at Steady State|Cmax was defined as the maximum concentration of pembrolizumab observed in plasma at steady state following multiple doses. Blood samples were collected pre-dose and post-dose at multiple time points up to 21 days during cycle 8 for Cmax assessment at steady state.|Cycle 8 Day 1: pre-dose [-1 to 0 hour] and post-dose at 0 [up to 0.5], 6 [up to 0.5], 24, 48, 168, 336, and 504 [±2 for 24 to 504] hours after completion of pembrolizumab infusion. Cycle 8 up to 175 days (Cycle 1 = 28 days, Cycles 2-8 = 21 days).|All randomized participants who received a pembrolizumab dose, had available Cmax data, and who did not have any protocol deviation interfering with PK.|||g/mL||95% Confidence Interval|Geometric Mean
2550381|NCT02835690|Primary|Multiple Dose PK: AUC(0-21 Days) of Pembrolizumab at Steady State|AUC was defined as a measure of pembrolizumab exposure that was calculated as the product of plasma drug concentration and time at steady state following multiple doses. Blood samples were collected pre-dose and post-dose at multiple time points up to 21 days during cycle 8 for AUC(0-21 days) assessment at steady state.|Cycle 8 Day 1: pre-dose [-1 to 0 hour] and post-dose at 0 [up to 0.5], 6 [up to 0.5], 24, 48, 168, 336, and 504 [±2 for 24 to 504] hours after completion of pembrolizumab infusion. Cycle 8 up to 175 days (Cycle 1 = 28 days, Cycles 2-8 = 21 days).|All randomized participants who received a pembrolizumab dose, had available AUC(0-21 days) data, and who did not have any protocol deviation interfering with PK.|||μg•day/mL||95% Confidence Interval|Geometric Mean
2550466|NCT02833857|Primary|Change From Baseline in Blood Pressure at End of Study||Baseline and day 30 (end of study)|Treated participants|||mmHg||Standard Deviation|Mean
2550467|NCT02833857|Primary|Change From Baseline in Temperature at End of Study||Baseline and day 30 (end of study)|Treated participants|||degrees celsius||Standard Deviation|Mean
2550382|NCT02835690|Primary|Multiple Dose PK: Trough Plasma Concentration (Ctrough) of Pembrolizumab|Ctrough was defined as the minimum concentration that occurred immediately prior to the administration of pembrolizumab in Cycle 8. Blood samples were collected pre-dose at Cycle 8 to estimate Ctrough following multiple dose administrations of pembrolizumab.|Cycle 8 Day 1: pre-dose [-1 to 0 hour]. Cycle 8 up to 175 days (Cycle 1 = 28 days, Cycles 2-8 = 21 days).|All randomized participants who received a pembrolizumab dose, had available Ctrough data, and who did not have any protocol deviation interfering with PK.|||μg/mL||95% Confidence Interval|Geometric Mean
2550383|NCT02835690|Primary|Single Dose PK: Apparent Terminal Half-Life (t1/2) of Pembrolizumab|t½ was defined as the time required to divide the pembrolizumab plasma concentration by two after reaching pseudo-equilibrium, following a single dose of pembrolizumab. Blood samples were collected pre-dose and post-dose at multiple time points up to 28 days at cycle 1 to estimate t½ following single dose administration.|Cycle 1 Day 1: pre-dose [-1 to 0 hour] and post-dose at 0 [up to 0.5], 6 [±0.5], 24, 48, 168, 336, and 504 [±2 for 24 to 504] hours after completion of pembrolizumab infusion. Cycle 1= 28 days|All randomized participants who received a pembrolizumab dose, with available PK data, and who did not have any protocol deviation interfering with PK.|||Day||Full Range|Median
2550384|NCT02835690|Primary|Single Dose PK: Time to Cmax (Tmax) of Pembrolizumab|Tmax was defined as the time required post dosing to reach a maximum plasma concentration of pembrolizumab. Blood samples were collected pre-dose and post-dose at multiple time points up to 28 days at cycle 1 to estimate Tmax following single dose administration.|Cycle 1 Day 1: pre-dose [-1 to 0 hour] and post-dose at 0 [up to 0.5], 6 [±0.5], 24, 48, 168, 336, and 504 [±2 for 24 to 504] hours after completion of pembrolizumab infusion. Cycle 1= 28 days|All randomized participants who received a pembrolizumab dose, with available PK data, and who did not have any protocol deviation interfering with PK.|||day||Full Range|Median
2550385|NCT02835690|Primary|Single-Dose PK: Maximum Plasma Concentration (Cmax) of Pembrolizumab|Cmax was defined as the maximum concentration of pembrolizumab observed in plasma following a single dose. Blood samples were collected pre-dose and post-dose at multiple time points up to 28 days during cycle 1 to estimate Cmax following single dose administration.|Cycle 1 Day 1: pre-dose [-1 to 0 hour] and post-dose at 0 [up to 0.5], 6 [±0.5], 24, 48, 168, 336, and 504 [±2 for 24 to 504] hours after completion of pembrolizumab infusion. Cycle 1= 28 days|All randomized participants who received a pembrolizumab dose, with available PK data, and who did not have any protocol deviation interfering with PK.|||μg/mL||95% Confidence Interval|Geometric Mean
2550386|NCT02835690|Primary|Single Dose PK: Area Under the Plasma Concentration Curve From 0-28 Days (AUC[0-28 Days]) of Pembrolizumab|AUC was defined as a measure of pembrolizumab exposure that was calculated as the product of plasma drug concentration and time. Blood samples were collected pre-dose and post-dose at multiple time points up to 28 days during cycle 1 to estimate AUC(0-28 days) following single dose administration.|Cycle 1 Day 1: pre-dose [-1 to 0 hour] and post-dose at 0 [up to 0.5], 6 [±0.5], 24, 48, 168, 336, and 504 [±2 for 24 to 504] hours after completion of pembrolizumab infusion. Cycle 1= 28 days|All randomized participants who received a pembrolizumab dose, with available pharmacokinetic (PK) data, and who did not have any protocol deviation interfering with PK.|||μg•day/mL||95% Confidence Interval|Geometric Mean
2550387|NCT02835690|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to be a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who discontinued study treatment due to an AE was reported.|Up to ~13 months (through database cut-off date of 19-Sept-2017)|All randomized participants that received at least one dose of study treatment.|||Participants|||Count of Participants
2550388|NCT02835690|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to be a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who experienced at least one AE was reported.|Up to ~13 months (through database cut-off date of 19-Sept-2017)|All randomized participants that received at least one dose of study treatment.|||Participants|||Count of Participants
2550389|NCT02835677|Primary|Bother With Patient MS Problems|Number of troubling patient problems or concerns that bother the caregiver, range 0-27, lower better|Baseline, 6 months||||units on a scale||Standard Error|Mean
2550390|NCT02835677|Primary|Number of Patient MS Problems|Caregiver primary outcome - number of possible troubling patient problems and concerns, range 0-27, lower better|baseline, 6 months||||units on a scale||Standard Error|Mean
2550391|NCT02835677|Primary|Anxiety Measured With the Generalized Anxiety Disorders 7 Scale|Caregiver primary outcome. General Anxiety Disorders Scale - GAD-7, range 0-21, lower better|baseline, 6 months||||units on a scale||Standard Error|Mean
2550392|NCT02835677|Primary|Burden Measured With the Zarit Burden Inventory|Caregiver primary outcome. Zarit Burden Inventory, 12 item, 0-48, lower better|baseline, 6 months||||units on a scale||Standard Error|Mean
2550393|NCT02835677|Primary|Depression Measured With the Patient Health Questionnaire 9 (PHQ-9) Scale|Caregiver primary outcome. PHQ-9, range 0-27, lower better|baseline, 6 months||||units on a scale||Standard Error|Mean
2550394|NCT02835274|Primary|Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase|"Mean change in Unified Parkinson's Disease Rating Scale (UPDRS) scores - motor section (Part III) at end of randomized phase in meds ON condition~Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state"|Up to 12 months post-implant||||units on a scale||Standard Deviation|Mean
2550468|NCT02833857|Primary|Change From Baseline in Heart Rate at End of Study||Baseline and day 30 (end of study)|Treated participants|||beats/minute||Standard Deviation|Mean
2550395|NCT02835092|Primary|Body Weight Change|Body weight (in gown, without shoes) was measured at each clinic visit on a medical quality digital scale (Health-o-meter 349KLX, Pelstar, McCook, IL) following a 10-14-hr fast. The relevant time points to determine body weight change were baseline and 16 weeks. The value for body weight at 16 weeks minus the value at baseline was the calculation used to determine body weight change.|16 weeks|Intent-to-Treat population, includes all participants randomized into the study.|||kg||Standard Error|Mean
2550396|NCT02834819|Secondary|Hospital Admission After Discharge|Admission to any hospital institution within 7 days following enrollment visit|Within 7 days following discharge from enrollment visit|5 patients did not complete the 7 day phone call and were not able to be analyzed for this outcome measure.|||Participants|||Count of Participants
2550397|NCT02834819|Secondary|Adverse Outcomes|Respiratory distress, increased oxygen requirement, advanced airway interventions (NIPPV or intubation).|During enrollment visit or within 7 days following enrollment visit||||Participants|||Count of Participants
2550398|NCT02834819|Secondary|Unscheduled Return ED Visits|"Unscheduled visit to ED within 3 days of enrollment visit.~Patients in each group will be contacted 7 days after the enrollment visit to see if they had any unscheduled return ED visit within 3 days of the enrollment visit."|Called at 7 days post enrollment visit to assess any visit within 3 days of enrollment visit||||Participants|||Count of Participants
2550399|NCT02834819|Secondary|Post-intervention Clinical Severity Score|Clinical severity score taken at time 90 minutes in both arms to assess any change in clinical severity score from baseline. The Scale utilized was the Clinical Severity Score from Wang et al, which measures respiratory distress in young children. The system assigns scores ranging from 0 to3 for the following categories: respiratory rate, wheezing, retraction, and general condition. These category scores are then summed to come up with the final Clinical Severity Score. Total scores range from 0 to 12, with higher scores indicating greater severity/worse outcomes.|During enrollment visit - 90 minutes after randomization||||score on a scale||Standard Deviation|Mean
2550400|NCT02834819|Secondary|Pre- Intervention Clinical Severity Score|Clinical severity score taken immediately following randomization, and prior to any intervention to assess change in baseline after intervention and compare change in scores, if any, between the two groups. The Scale utilized was the Clinical Severity Score from Wang et al, which measures respiratory distress in young children. The system assigns scores ranging from 0 to 3 for the following categories: respiratory rate, wheezing, retraction, and general condition. These category scores are then summed to come up with the final Clinical Severity Score. Total scores range from 0 to 12, with higher scores indicating greater severity/worse outcomes.|During Enrollment visit following randomization.||||score on a scale||Standard Deviation|Mean
2550401|NCT02834819|Primary|Need for Supplemental Oxygen After Discharge|To assess the effect of nebulized hypertonic saline on supplemental home oxygen requirement in children with bronchiolitis compared to those who receive the current standard of care.|At time of discharge from the hospital through 7 days.||||Participants|||Count of Participants
2550402|NCT02834819|Primary|Number of Patients With Persistent Hypoxia|To assess the effect of nebulized hypertonic saline on hypoxia in children with bronchiolitis compared to those who receive current standard of care.|At baseline and 90 minutes post-intervention||||Participants|||Count of Participants
2550403|NCT02834819|Primary|Hospitalization Rate|Effect of nebulized 3% hypertonic saline on hospitalization rate in children with bronchiolitis compared to those who receive the current standard of care|At any point during enrollment visit or up to 7 days after enrollment visit.||||Participants|||Count of Participants
2550404|NCT02834663|Secondary|Safety Parameters|Systemic adverse events (MI, CVA, etc), Ocular adverse events (retinal detachment, RPE tear, endophthalmitis, uveitis, vitreous hemorrhage, subretinal hemorrhage, cataract , IOP elevation, etc)|6 months|Totally, 25 eyes of 25 patients (13 males, 12 females, mean age 63.80±11.45 years; range: 41–80 years) were included in the study.|||Participants|||Count of Participants
2550405|NCT02834663|Secondary|Perifoveal Non-perfusion Area in FAG (mm²)|Using ImageJ software (version 1.52a) by FAG image|6 months|Totally, 25 eyes of 25 patients (13 males, 12 females, mean age 63.80±11.45 years; range: 41–80 years) were included in the study.|||mm2||Standard Deviation|Mean
2550406|NCT02834663|Secondary|The Microaneurysm Turnover|The microaneurysm formation rate + The microaneurysm disappearance rate The MAs in individual retinas were evaluated at 6 months using fundus photography. The Retmarker (version 1.0.2 by Retmarker Ltd, Coimbra, Portugal) software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs. MA turnover was calculated by adding the MA formation rate (number of new MAs detected/month) to the MA disappearance rate (number of MAs that resolved/month)|6 months|Totally, 25 eyes of 25 patients (13 males, 12 females, mean age 63.80±11.45 years; range: 41–80 years) were included in the study.|||count||Standard Deviation|Mean
2550407|NCT02834663|Secondary|The Microaneurysm Disappearance Rate|Number of MAs that resolved/month The MAs in individual retinas were evaluated at 6 months using fundus photography. The Retmarker (version 1.0.2 by Retmarker Ltd, Coimbra, Portugal) software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs. MA turnover was calculated by adding the MA formation rate (number of new MAs detected/month) to the MA disappearance rate (number of MAs that resolved/month)|6 months|Totally, 25 eyes of 25 patients (13 males, 12 females, mean age 63.80±11.45 years; range: 41–80 years) were included in the study.|||count||Standard Deviation|Mean
2550408|NCT02834663|Secondary|The Microaneurysm Formation Rate|number of new MAs detected/month The MAs in individual retinas were evaluated at 6 months using fundus photography. The Retmarker (version 1.0.2 by Retmarker Ltd, Coimbra, Portugal) software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs. MA turnover was calculated by adding the MA formation rate (number of new MAs detected/month) to the MA disappearance rate (number of MAs that resolved/month)|6 months|Totally, 25 eyes of 25 patients (13 males, 12 females, mean age 63.80±11.45 years; range: 41–80 years) were included in the study.|||count||Standard Deviation|Mean
2550469|NCT02833857|Primary|Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time||Baseline and day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)|Treated participants with available data at each time point.|||pmol/L||Standard Deviation|Mean
2550409|NCT02834663|Secondary|The Total Number of Microaneurysm|The number of MAs in individual retinas were evaluated during 6 months using fundus photography and FA imaging. The Retmarker software was used for automatic measurement and analysis of changes in number and extent of MAs on fundus photographs and to calculate the total number and turnover of MAs. Changes in MAs were analyzed statistically.|6 months|Totally, 25 eyes of 25 patients (13 males, 12 females, mean age 63.80±11.45 years; range: 41–80 years) were included in the study.|||count||Standard Deviation|Mean
2550410|NCT02834663|Primary|Central Macular Thickness(CMT)|CRT was performed using OCT at each visit. The OCT measured at each visit was analyzed statistically.|6 months|Totally, 25 eyes of 25 patients (13 males, 12 females, mean age 63.80±11.45 years; range: 41–80 years) were included in the study.|||um||Standard Deviation|Mean
2550411|NCT02834663|Primary|The Best Corrected Visual Acuity (BCVA)|BCVA was performed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at each visit. The BCVA measured at each visit was analyzed statistically.|6 months|Totally, 25 eyes of 25 patients (13 males, 12 females, mean age 63.80±11.45 years; range: 41–80 years) were included in the study.|||letters||Standard Deviation|Mean
2550412|NCT02834624|Secondary|Change in Number of Tracheal Macrophages|measurement of lipid peroxidation in tracheal aspirate samples and cytology of tracheal aspirates.in tracheal aspirate|baseline, 48 hours||||white cells/high-powered field||Standard Deviation|Mean
2550413|NCT02834624|Secondary|Presence of Pulmonary Hemorrhage|Significant and Persistent Blood present in the trachea during endotracheal tube suctioning.|intraoperative|This data is unavailable from the research department as it was not collected.||||||
2550414|NCT02834624|Primary|Change From Baseline in Blood C-reactive (CRP) Protein|Difference between measurement of CRP at baseline and 48 hours after administration of surfactant|baseline, 48 hours||||mg/dL||Standard Deviation|Mean
2550415|NCT02834247|Secondary|Part 1, Dose Escalation Phase, AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for Area Under the Plasma Concentration for TAK-659||Cycle 1, Days 1 and 15: pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)|The PK-evaluable population was defined as participants with sufficient concentration-time and dosing data to reliably estimate PK parameters. PK-evaluable population where data at specified time points was available.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2550416|NCT02834247|Secondary|Part 1, Dose Escalation Phase, Tmax: Time to Reach the Cmax for TAK-659||Cycle 1, Days 1 and 15: pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)|The PK-Evaluable population was defined as participants with sufficient concentration-time and dosing data to reliably estimate PK parameters. PK-evaluable population where data at specified time points was available.|||hour||Full Range|Median
2550417|NCT02834247|Secondary|Part 1, Dose Escalation Phase, Cmax: Maximum Observed Plasma Concentration for TAK-659||Cycle 1, Days 1 and 15: pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)|The pharmacokinetic (PK)-evaluable population was defined as participants with sufficient concentration-time and dosing data to reliably estimate PK parameters. PK-evaluable population where data at specified time points was available.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2550418|NCT02834247|Secondary|Part 2, Dose Expansion Phase: Overall Survival (OS)|OS was calculated from date of participant enrollment to the date of participant's death due to any cause. OS was assessed based on RECIST v 1.1. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier. OS was calculated using Kaplan-Meier estimate. Enrollment was defined as the time of the initiation of the first dose of study drug.|Baseline up to the date of death due to any cause (up to 28 months)|The safety population was defined as all the participants who received at least 1 dose of study drug.|||months||95% Confidence Interval|Median
2550419|NCT02834247|Secondary|Part 2, Dose Expansion Phase: Progression Free Survival (PFS)|PFS was defined as the time from date of first study drug administration to the date of first documented PD or death due to any cause, whichever occurred first. The PFS assessment was based on RECIST v1.1. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was calculated using Kaplan-Meier estimate.|From the date of first study drug administration up to date of first documented PD or death due to any cause, whichever occurred first (up to 28 months)|The safety population was defined as all the participants who received at least 1 dose of study drug.|||months||95% Confidence Interval|Median
2550420|NCT02834247|Secondary|Part 2, Dose Expansion Phase: Percentage of Participants With PD at Month 6|PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. The PD assessment was based on RECIST v1.1.|Month 6|The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at Baseline, and had at least 1 post-baseline disease assessment.|||percentage of participants|||Number
2550421|NCT02834247|Secondary|Part 2, Dose Expansion Phase: Duration of Response (DOR)|DOR was defined as the time from the date of first documentation of a response to the date of first documented progressive disease. DOR assessment was based on RECIST v1.1. CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to <10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. DOR was calculated using Kaplan-Meier analysis.|From the date of first documentation of a response to the date of first documented PD (up to 28 months)|The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at Baseline, and had at least 1 post-baseline disease assessment.|||months||95% Confidence Interval|Median
2550470|NCT02833857|Primary|Change From Baseline in Serum Potassium Concentration at End of Study||Baseline and day 30 (end of study)|Treated participants|||mmol/L||Standard Deviation|Mean
2550471|NCT02833857|Primary|Change From Baseline in Serum Phosphorus Concentration at End of Study||Baseline and day 30 (end of study)|Treated participants|||mmol/L||Standard Deviation|Mean
2550422|NCT02834247|Secondary|Part 2, Dose Expansion Phase: Disease Control Rate (DCR)|DCR was the percentage of participants who had BOR with either CR, PR, or stable disease (SD). The DCR assessment was based on RECIST version 1.1. The BOR was defined as the best response recorded from the start of the study treatment until the start of subsequent anticancer therapy. CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to <10 mm. PR: was at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD.|From the start of study treatment until the start of subsequent anticancer therapy (up to 28 months)|The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at Baseline, and had at least 1 post-baseline disease assessment.|||percentage of participants|||Number
2550423|NCT02834247|Secondary|Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Events (TEAEs), Grade 3 or 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation|AEs Grades were evaluated as per NCI CTCAE version 4.03.|From the first dose of the study drug up to 28 days after the last dose of the study drug or the start of subsequent anticancer therapy (up to 28 months)|The safety population was defined as all the participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2550424|NCT02834247|Primary|Part 2, Dose Expansion Phase: Overall Response Rate (ORR)|ORR was defined as the percentage of participants who's best overall response (BOR) was either complete response (CR) or partial response (PR). The ORR assessment was based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The BOR was defined as the best response recorded from the start of the study treatment until the start of subsequent anticancer therapy. CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (<) 10 millimeter (mm). PR: was at least a 30 percent (%) decrease in sum of diameter (SOD) of target lesions, taking as reference the baseline SOD.|From the start of study treatment until the start of subsequent anticancer therapy (up to 28 months)|The response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at Baseline, and had at least 1 post-baseline disease assessment.|||percentage of participants|||Number
2550425|NCT02834247|Primary|Part 1, Dose Escalation Phase: Recommendation Phase 2 Dose (RP2D)|RP2D was evaluated from cumulative toxicities in Cycle 1 and beyond. Toxicities were evaluated according to NCI CTCAE version 4.03.|Up to Cycle 12 (each Cycle length is equal to [=] 28 days)|The DLT-evaluable population was defined as participants who had met the minimum treatment and safety evaluation requirements of the study and/or who experienced a DLT during Cycle 1.|||mg|||Number
2550426|NCT02834247|Primary|Part 1, Dose Escalation Phase: Maximum Tolerated Dose (MTD)|The MTD was defined as the dose range at which less than or equal to (<=) 1 of 6 evaluable participants experience dose limiting toxicities (DLT) within the first 28 days of treatment (end of Cycle 1). Toxicities were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.|At end of Cycle 1 Day 28|The DLT-evaluable population was defined as participants who had met the minimum treatment and safety evaluation requirements of the study and/or who experienced a DLT during Cycle 1.|||mg|||Number
2550427|NCT02833974|Secondary|Number of Participants With Abnormal Urine Analysis Findings|Urine samples were collected for analysis of specific gravity, potential of hydrogen ions, glucose, protein, blood and ketones by dipstick method. Microscopic examination were performed if blood or protein values were abnormal.|Up to Week 8|All Subjects Population.|||Participants|||Count of Participants
2550428|NCT02833974|Secondary|Number of Participants With Clinical Chemistry Values of Potential Clinical Concern|Blood samples were collected for analysis of clinical chemistry parameters. Clinical chemistry parameters included blood urea nitrogen, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein, total and direct bilirubin, albumin, calcium, creatinine, glucose, potassium and sodium.|Up to Week 8|All Subjects Population.|||Participants|||Count of Participants
2550429|NCT02833974|Secondary|Number of Participants With Hematology Values of Potential Clinical Concern|Blood samples were collected for analysis of hematology parameters. Hematology parameters included hematocrit, hemoglobin, platelet count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, mean corpuscular volume, mean corpuscular hemoglobin, and red blood cells (RBC).|Up to Week 20|All Subjects Population.|||Participants|||Count of Participants
2550430|NCT02833974|Secondary|Number of Participants Receiving Rescue Medication|Salbutamol was administered as rescue medication only to participants who experienced serious discomfort. The data below exclude any Salbutamol administered as part of the planned study procedures (for example the Salbutamol administered after the Bronchial Allergen Challenge [BAC] is not counted as a rescue medication).|Up to Week 20|All Subjects Population|||Participants|||Count of Participants
2550431|NCT02833974|Secondary|Number of Participants With Abnormal Peak Expiratory Flow (PEF)|The PEF is defined as the greatest rate of airflow that can be achieved during forced exhalation beginning with the lungs fully inflated. Participants were instructed to record their PEF readings each morning and evening into the diary card that was provided by the investigator. The minimum and maximum range ranges for PEF were <=205 and >=980 liters per minute.|Up to Week 12|All Subjects Population|||Participants|||Count of Participants
2550432|NCT02833974|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported.|Up to Week 20|All Subjects Population comprise of all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2550472|NCT02833857|Primary|Change From Baseline in Serum Corrected Calcium Concentration Over Time|When albumin was less than 4.0 mg/dL, the calcium concentration was corrected according to the formula: cCa (mmol/L) = measured total serum calcium (mmol/L) + 0.02 (40 - serum albumin [g/L]).|Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)|Treated participants with available data at each time point.|||mmol/L||Standard Deviation|Mean
2550433|NCT02833974|Secondary|EAR: Absolute Change From Saline in Weighted Mean FEV1 Between 0-2 Hours Following Allergen Challenge One Week After Treatment.|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to BAC at the one-week follow-up visit (one week after the eighth dose of the study treatment). Weighted mean FEV1 over 0-2 hours post-allergen challenge includes all post-saline time points between 0-2 hours post-allergen challenge, inclusive of 0 and 2 hours timepoints. The weighted mean FEV1 was derived by calculating the area under the curve, and dividing the value by the relevant time interval. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value.|Week 9|Per-Protocol Population. Only those participants with data available at specified time points were analyzed|||Liters||Standard Deviation|Mean
2550434|NCT02833974|Secondary|Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 Between 0-2 Hours Following Allergen Challenge One Week After Treatment|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to BAC at the one-week follow-up visit (one week after the eighth dose of the study treatment). Minimum FEV1 over 0-2 hours post-allergen challenge (minimum LAR) is the minimum value of all of the post-saline time points between 0 and 2 hours post-allergen challenge, inclusive of the 0 and 2 hours timepoints. Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value.|Week 9|Per-Protocol Population. Only those participants with data available at specified time points were analyzed|||Liters||Standard Deviation|Mean
2550435|NCT02833974|Primary|LAR: Absolute Change From Saline in Weighted Mean FEV1 Between 4-10 Hours Following Allergen Challenge One Week After Treatment|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to BAC at the one-week follow-up visit (one week after the eighth dose of the study treatment). Weighted mean FEV1 over 4-10 hours post-allergen challenge includes all post-saline time points between 4 and 10 hours post-allergen challenge, inclusive of the 4 and 10 hours timepoints. The weighted mean FEV1 was derived by calculating the area under the curve, and dividing the value by the relevant time interval. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value.|Week 9|Per-Protocol Population. Only those participants with data available at specified time points were analyzed|||Liters||Standard Deviation|Mean
2550436|NCT02833974|Primary|Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum Forced Expiratory Volume in 1 Second (FEV1) Between 4-10 Hours Following Allergen Challenge One Week After Treatment|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to bronchial allergen challenge (BAC) at the one-week follow-up visit (one week after the eighth dose of the study treatment). Minimum FEV1 over 4-10 hours post-allergen challenge (minimum LAR) is the minimum value of all of the post-saline time points between 4 and 10 hours post-allergen challenge, inclusive of the 4 and 10 hours timepoints. Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. Per-Protocol Population comprises of all randomized participants who received at least one dose of study treatment and commence a BAC at follow-up and comply with the protocol.|Week 9|Per-Protocol Population. Only those participants with data available at specified time points were analyzed|||Liters||Standard Deviation|Mean
2550437|NCT02833948|Secondary|Thromboembolic Event Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (RLM) - as Exploratory Analysis.|Thromboembolic event, Dichotomization by RLM|3 months|Intention-to-treat (ITT) study population, subgroup of patients with analysable scans|||Participants|||Count of Participants
2550438|NCT02833948|Secondary|Thromboembolic Event Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (HALT)- as Exploratory Analysis.|Thromboembolic event, Dichotomization by HALT|3 months|Intention-to-treat (ITT) study population, subgroup of patients with analysable scans|||Participants|||Count of Participants
2550439|NCT02833948|Secondary|Death Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (RLM)- as Exploratory Analysis.|Death, Dichotomization by RLM|3 months|Intention-to-treat (ITT) study population, subgroup of patients with analysable scans|||Participants|||Count of Participants
2550440|NCT02833948|Secondary|Death Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (HALT) - as Exploratory Analysis.|Death, Dichotomization by HALT|3 months|Intention-to-treat (ITT) study population, subgroup of patients with analysable scans|||Participants|||Count of Participants
2550441|NCT02833948|Secondary|Effective Orifice Area (cm^2) as Determined by Transthoracic Echocardiography.|"Effective orifice area (cm2) as determined by transthoracic echocardiography at three months after randomization.~scale [0.1-4.0]"|3 months|Intention-to-treat (ITT) study population|||cm2||Standard Deviation|Mean
2550442|NCT02833948|Secondary|Aortic Transvalvular Mean Pressure Gradient (mmHg) as Determined by Transthoracic Echocardiography.|"Transprosthetic mean pressure gradiënt as determined by transthoracic echocardiography at three months after randomization.~scale [0-100]"|3 months|Intention-to-treat (ITT) study population|||mm Hg||Standard Deviation|Mean
2550443|NCT02833948|Secondary|The Rate of Prosthetic Leaflets With Thickening as Assessed by Cardiac 4DCT-scan|The rate of prosthetic leaflet with HALT as assessed by cardiac 4DCT-scan|3 months|Intention-to-treat (ITT) study population|||Leaflets|Leaflets||Number
2550444|NCT02833948|Secondary|The Rate of Patients With at Least One Prosthetic Leaflet With Thickening as Assessed by Cardiac 4DCT-scan|The rate of patients with at least one prosthetic leaflet with hypoattenuated leaflet thickening (HALT) as assessed by cardiac 4DCT.|3 months|Intention-to-treat (ITT) study population|||Participants|||Count of Participants
2550445|NCT02833948|Secondary|The Rate of Prosthetic Leaflets With > 50% Motion Reduction as Assessed by Cardiac 4DCT-scan|The rate of prosthetic leaflets with RLM> grade 3 as assessed by cardiac 4DCT|3 months|Intention-to-treat (ITT) study population|||leaflets|leaflets||Number
2550516|NCT02832284|Secondary|Visualization|Lesions visualized during iNod Maneuvers|Intraprocedural|Lesions visualized per attempt to visualize lesion|||Lesions visualization attempts|Lesions visualization attempts||Count of Units
2550446|NCT02833948|Primary|Rate of Patients With at Least One Prosthetic Leaflet With >50% Motion Reduction as Assessed by Cardiac 4DCT-scan|Reduced systolic leaflet excursion is classified as: (I) normal, (II) mildly reduced (<50%), (III) moderate to severely reduced (>50%), and (IV) immobile. Reduced systolic leaflet excursion is considered significant when it is > 50% or immobile. Quantitative assessment of leaflet motion is performed with a blood pool inversion volume rendered cine reconstruction throughout the cardiac cycle evaluating the bioprosthetic leaflets.|3 months|Intention-to-treat (ITT) study population|||Participants|||Count of Participants
2550447|NCT02833922|Secondary|User Perceived Impact of the Dot App|The Dot app has increased my awareness of the importance of knowing my fertile window, in order to prevent pregnancy|1 year|Users who took the 10-month follow-up survey|||Participants|||Count of Participants
2550448|NCT02833922|Secondary|User Acceptability of App-based, Self-reported Data Collection||1 year||||Participants|||Count of Participants
2550449|NCT02833922|Secondary|Perceived Partner Support|687 out of 718 women completed the survey where we asked about perceived partner support. The survey was not mandatory and some women did not complete the study or exited the study prior to its administration.|1 year||||Participants|||Count of Participants
2550450|NCT02833922|Secondary|Intent to Continue Using the Method at Study Completion|46.8% of women reported on their 13th cycle that they intend to keep using Dot to prevent pregnancy.|1 year||||Participants|||Count of Participants
2550451|NCT02833922|Primary|Pregnancy Rates|Pregnancy rates during perfect and typical use of the Dynamic Optimal Timing method to avoid pregnancy in a way directly comparable to the approach used in recent family planning effectiveness studies|1 year||||Participants|||Count of Participants
2550452|NCT02833857|Secondary|Number of Participants With Treatment-emergent Adverse Events|A treatment-emergent adverse event is any adverse event that begins or worsens after the initial dose of study drug (etelcalcetide) and up to 30 days after the last dose. The severity of each adverse event was graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = Mild (asymptomatic or mild symptoms), Grade 2 = Moderate (minimal, local or noninvasive intervention indicated), Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated, Grade 4 = Life-threatening consequences; urgent intervention indicated, and Grade 5 = Death related to AE.|30 days|All Treated participants|||Participants|||Count of Participants
2550453|NCT02833857|Secondary|Number of Participants Who Developed Anti-etelcalcetide Binding Antibodies|"Samples were collected predose and at end of study (day 30) and tested for anti etelcalcetide binding antibodies using a validated immunoassay.~Developing antibody binding was defined as participants who were binding antibody positive postbaseline with a negative result at baseline."|Baseline and day 30|Treated participants|||Participants|||Count of Participants
2550454|NCT02833857|Secondary|Terminal Half-life (T1/2,z) of Etelcalcetide|"Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.~Terminal half life of plasma etelcalcetide (t1/2,z) was calculated as t1/2,z = ln(2)/λz, where λz is the first-order terminal rate constant estimated by linear regression of the terminal log-linear phase."|10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose|Pharmacokinetic analysis set with available T1/2,z data|||days||Standard Deviation|Mean
2550455|NCT02833857|Secondary|Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero Infinity (AUCinf)|"Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.~Area under the concentration-time curve from time zero to infinite time (AUCinf) was estimated using the linear trapezoidal method."|10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose|Pharmacokinetic analysis set with available AUCinf data|||hr*ng/mL||Standard Deviation|Mean
2550456|NCT02833857|Secondary|Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)|"Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.~Area under the curve for plasma etelcalcetide from time zero to the last quantifiable concentration (AUClast) was estimated using the linear trapezoidal method."|10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose|Pharmacokinetic analysis set|||hr*ng/mL||Standard Deviation|Mean
2550457|NCT02833857|Secondary|Time to Maximum Concentration (Tmax) of Etelcalcetide|Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.|10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose|The pharmacokinetic concentration analysis set was composed of all participants who received etelcalcetide and had at least 1 pharmacokinetic sample collected.|||hours||Full Range|Median
2550458|NCT02833857|Secondary|Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide|Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.|10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose|The pharmacokinetic analysis set|||ng/mL||Standard Deviation|Mean
2550459|NCT02833857|Secondary|Change From Baseline in Serum Ionized Calcium Concentration||Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)|Treated participants with available data at each time point.|||mmol/L||Standard Deviation|Mean
2550460|NCT02833857|Secondary|Change From Baseline in Serum Total Calcium Concentration||Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)|Treated participants with available data at each time point.|||mmol/L||Standard Deviation|Mean
2550461|NCT02833857|Primary|Change From Baseline in Corrected (Fridericia) QT Interval at End of Study||Baseline and day 30 (end of study)|Treated participants|||ms||Standard Deviation|Mean
2550462|NCT02833857|Primary|Change From Baseline in Corrected (Bazett) QT Interval at End of Study||Baseline and day 30 (end of study)|Treated participants|||ms||Standard Deviation|Mean
2550463|NCT02833857|Primary|Change From Baseline in QT Interval at End of Study||Baseline and day 30 (end of study)|Treated participants|||ms||Standard Deviation|Mean
2550464|NCT02833857|Primary|Change From Baseline in QRS Interval at End of Study||Baseline and day 30 (end of study)|Treated participants|||ms||Standard Deviation|Mean
2550465|NCT02833857|Primary|Change From Baseline in PR Interval at End of Study||Baseline and day 30 (end of study)|Treated participants|||ms||Standard Deviation|Mean
2550473|NCT02833857|Primary|Common Treatment-emergent Adverse Events|"A treatment-emergent adverse event is any adverse event (AE) that begins or worsens after the initial dose of study drug (etelcalcetide) and up to 30 days after the last dose.~Common adverse events were defined as adverse events occurring in at least 2 participants.~The Medical Dictionary for Regulatory Activities (MedDRA) version 21.0 was used for coding all adverse events."|30 days|Participants who received at least 1 dose of etelcalcetide (safety analysis set)|||Participants|||Count of Participants
2550474|NCT02833415|Primary|Change in Glycerol Enrichment|[U-13C3] glycerol enrichment in plasma blood glucose over time will be measured by nuclear magnetic resonance spectroscopy. This is a percentage change from baseline to follow up in the percent enrichment of exogenous glycerol in blood glucose. We are unable to report a measure of central tendency and dispersion as the outcome is a percent change in the area under the enrichment curve for each group between baseline and follow-up. There is no measure of central tendency for these measurements without bootstrapping, which was not performed.|3 months||||Percentage change|||Number
2550475|NCT02833350|Secondary|Minimum Observed Plasma Concentration of GDC-0853 at Steady State (Cmin,ss)|Cmin is the minimum concentration over the dosing interval at steady state (ss)|Pre-dose (0 hours) up to 10 hours post-dose on Day 28|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point. Data were presented only for arms in which GDC-0853 was administered.|||Nanogram per Milliliter (ng/mL)||Standard Deviation|Mean
2550476|NCT02833350|Secondary|Maximum Observed Plasma Concentration of GDC-0853 at Steady State (Cmax,ss)|Cmax is the maximum (peak) plasma concentration over the dosing interval at steady state (ss)|Pre-dose (0 hours) up to 10 hours post-dose on Day 28|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point. Data were presented only for arms in which GDC-0853 was administered.|||Nanogram per Milliliter (ng/mL)||Standard Deviation|Mean
2550477|NCT02833350|Secondary|Area Under the Concentration Time Curve From Time 0 to Time 24 of GDC-0853 at Steady State (AUC0-24,ss)|The Pharmacokinetics (PK) evaluation may include, but will not be limited to, plasma GDC-0853 concentrations and population PK model estimated PK exposures (area under the plasma concentration-time curve [AUC]. AUC was measured in Nanograms(ng) per millilitre(mL)*hour (hr)|Pre-dose (0 hours) up to 10 hours post-dose on Day 28|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point. Data were presented only for arms in which GDC-0853 was administered.|||Ng/mL*(hr)||Standard Deviation|Mean
2550478|NCT02833350|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|"The Stanford Health Assessment Questionnaire disability index is a patient-reported outcome used to assess difficulty in performing activities of daily living. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.~To respond to each question, a four-level response with higher scores showing larger functional limitations, was chosen. Scoring is as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. The composite HAQ-DI score is the mean of the eight domain scores and the score ranges from 0 (no functional impairment) to 3 (maximum functional impairment). A negative change from baseline indicates improvement."|Days 7, 14, 28, 56, and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Score on a scale||Standard Deviation|Mean
2550479|NCT02833350|Secondary|Change From Baseline in C-Reactive Protein (CRP) Levels|C-reactive protein is a biological marker of inflammation and is measured in nanograms per milliliter (ng/mL)|Days 7, 14, 28, 56, and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||(ng/mL) nanograms per milliliter||Standard Deviation|Mean
2550480|NCT02833350|Secondary|Change From Baseline in Physician's Global Assessment Score of Arthritis|Physician's assessment of participant's disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's assessment of the participant's disease activity (0 mm=very good; 100 mm=very poor). Change from baseline at a particular time point was calculated among patients with data available at both baseline and the time point of interest, where negative change from baseline indicated an improvement in physician-assessed disease activity.|Days 7, 14, 28, 56, and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Score on a scale||Standard Deviation|Mean
2550481|NCT02833350|Secondary|Change From Baseline in Patient Global Assessment Score of Arthritis Pain|Participant-assessed arthritis pain was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of arthritis pain (0 mm=none; 100 mm=very severe). Change from baseline at a particular time point was calculated among patients with data available at both baseline and the time point of interest, where negative change indicated a decrease in participant-assessed arthritis pain.|Days 7, 14, 28, 56, and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Score on a scale||Standard Deviation|Mean
2550482|NCT02833350|Secondary|Change From Baseline in Patient Assessment Score of Arthritis Pain|Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain|Days 7, 14, 28, 56, and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Score on a scale||Standard Deviation|Mean
2550517|NCT02832284|Secondary|Device/Procedure-Related Safety Events|Occurrence and severity of Adverse Events related to the iNod System biopsy procedures, as well as Adverse Events related to any subsequent Radial EBUS-guided salvage procedures.|Procedure through Post-procedure call; 6-8 days post-procedure.||||Participants|||Count of Participants
2550483|NCT02833350|Secondary|Change From Baseline in Swollen Joint Count (66 Joint Count)|Swollen Joint Count: a total of 66 joints will be assessed for swelling. Each joint is assessed for the presence/absence of swelling. 66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from Baseline indicated improvement.|Days 7, 14, 28, 56, and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Score on a scale||Standard Deviation|Mean
2550484|NCT02833350|Secondary|Change From Baseline in Tender/Painful Joint Count (68 Joint Count)|Tender Joint Count: a total of 68 joints will be assessed for tenderness. Each joint is assessed for the presence/absence of tenderness. 68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from Baseline indicated improvement.|Days 7, 14, 28, 56, and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Score on a scale||Standard Deviation|Mean
2550485|NCT02833350|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score|"The FACIT-Fatigue Scale consists of 13 items designed to measure the degree of fatigue experienced by the patient in the previous 7 days. For each question, there are five possible responses: 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), 4 (very much).~A total fatigue score is calculated by summing all items, and possible total scores range from 0 (maximum fatigue) to 52 (no fatigue). A positive change from baseline indicates an improvement in the patient's fatigue (less fatigue)."|Day 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Score on a scale||Standard Deviation|Mean
2550486|NCT02833350|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components|"The 36-Item Short Form Health Survey (SF-36v2) is a questionnaire used to assess functional health and well-being and consists of eight domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health.~The SF-36v2 is summarized into Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. The PCS and MCS scores range from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement."|Day 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Number on a scale||Standard Deviation|Mean
2550487|NCT02833350|Secondary|Percentage of Participants Meeting the SDAI-based Remission Criteria|The SDAI was the numerical sum of five outcome parameter: SJC and TJC (based on a 28-joint assessment), PGA and MDG (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. The SDAI =< 3.3 indicates disease remission|Days 7, 14, 28, 56, and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Percentage of participants||95% Confidence Interval|Number
2550488|NCT02833350|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI)|Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity|Baseline, Days 7, 14, 28, 56 and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Score on a scale||Standard Deviation|Mean
2550489|NCT02833350|Secondary|Percentage of Participants Meeting the CDAI-based Remission Criteria|Clinical Disease Activity Index is defined as CDAI= : SJC(28) + TJC(28) + PGA + MDG where TJC and SJC are the tender and swollen joint counts from 28 joints, PGA is the patient's global assessment of disease activity (on a 0-10 scale) and MDG is physician global assessment of disease activity (on a 0-10 scale). The cutoff value for CDAI remission is <=2.8.|Days 7, 14, 28, 56, and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Percentage of participants||95% Confidence Interval|Number
2550490|NCT02833350|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI)|CDAI was derived as the sum of the following: tender joint count (TJC), swollen joint count (SJC), participant global assessment (PGA) of disease activity, and physician assessment of disease activity. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 millimeters (mm) and rounded to the nearest centimeter (cm) on a visual analog scale (VAS), where higher scores indicate greater perceived disease activity. The total CDAI score range was 0-76, where higher scores indicate increased disease activity. Change from baseline at a particular time point was calculated among patients with data available at both baseline and the time point of interest. Negative values indicate improvement/reduction in RA disease activity.|Baseline, Days 7, 14, 28, 56 and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Score on a scale||Standard Deviation|Mean
2550491|NCT02833350|Secondary|Percentage of Participants Meeting the Boolean-based Remission Criteria|Boolean Remission is defined as Tender joint count less than 1, Swollen joint count less than 1, CRP less than 1 mg/dL, patient global assessment less than 1 (on 0 to 10 VAS scale).|Days 7, 14, 28, 56, and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Percentage of participants||95% Confidence Interval|Number
2550492|NCT02833350|Secondary|Percentage of Participants With DAS Remission|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6|Days 7, 14, 28, 56, and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Percentage of participants||95% Confidence Interval|Number
2550493|NCT02833350|Secondary|Percentage of Participants With DAS Low Disease Activity|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. LDAS is defined as DAS28 ≤ 3.2|Days 7, 14, 28, 56, and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point|||Percentage of participants||95% Confidence Interval|Number
2550494|NCT02833350|Secondary|Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.|Days 7, 14, 28, 56, and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Score on a scale||Standard Deviation|Mean
2550495|NCT02833350|Secondary|Change in Disease Activity Score From Baseline Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.|Days 7, 14, 28, 56, and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Score on a scale||Standard Deviation|Mean
2550496|NCT02833350|Secondary|Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.|Days 7, 14, 28, 56, and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Score on a scale||Standard Deviation|Mean
2550497|NCT02833350|Secondary|Change in Disease Activity Score From Baseline Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6.|Days 7, 14, 28, 56, and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Score on a scale||Standard Deviation|Mean
2550498|NCT02833350|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Days 7, 14, 28, 56, and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Percentage||95% Confidence Interval|Number
2550518|NCT02832284|Primary|Acquisition of Adequate Specimens of Targeted Lung Lesions|The primary endpoint for the iNod Feasibility Study was clinical success, defined as the iNod System's ability to acquire adequate specimens of cellular matter suitable for the cytologic evaluation of targeted lung lesions, under real-time visualization.|Intraprocedural||||Participants|||Count of Participants
2572005|NCT02512393|Primary|Heat Pain Tolerance|Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.|baseline||||Celsius||Standard Deviation|Mean
2550499|NCT02833350|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Days 7, 14, 28, 56, and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Percentage||95% Confidence Interval|Number
2550500|NCT02833350|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate]|Days 7, 14, 28, 56, and 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Percentage||95% Confidence Interval|Number
2550501|NCT02833350|Secondary|Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 2)|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Day 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Percentage||95% Confidence Interval|Number
2550502|NCT02833350|Secondary|Percentage of Participants Achieving ACR50 Response at Day 84, Comparison Between GDC-0853 and Adalimumab (Cohort 1)|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Day 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Percentage||95% Confidence Interval|Number
2550503|NCT02833350|Primary|Percentage of Participants With Adverse Events|An Adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE was any experience that suggested a significant hazard, contraindication, side effect or precaution that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|Day 1 up to 8 weeks after last dose (up to Week 20)|Safety population included all participants according to treatment administered.|||Percentage|||Number
2550504|NCT02833350|Primary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 84, Comparison Between GDC-0853 and Placebo (Cohort 1)|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Day 84|Intent-to-Treat (ITT) All randomized participants who received any part of an infusion of study medication were included in the ITT analysis. Number of participants for whom data were collected is indicated for each time point.|||Percentage||95% Confidence Interval|Number
2572006|NCT02512393|Primary|Heat Pain Threshold|Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.|day 5||||Celsius||Standard Deviation|Mean
2550505|NCT02832674|Secondary|Subject Global Satisfaction Questionnaire (S-GSQ)|A subjective assessment of global satisfaction as measured by the participant using the S-GSQ where the participant rates his/her level of satisfaction of the treatment and treated area based on 4 satisfaction questions respective to 1. changes to the treated area, 2. skin texture of the treated area, 3. satisfaction with treatment results and 4. likelihood to recommend the treatment as a treatment option.|Change from baseline at Days 90 and 180|Of the 72 enrolled and treated subjects, 69 completed the day 90 visit and 67 completed the day 180 visit (4 subjects were lost to follow up and one subject withdrew consent)|||percentage of participants||95% Confidence Interval|Mean
2550506|NCT02832674|Secondary|Physician Global Satisfaction Questionnaire (P-GSQ)|A subjective assessment of global satisfaction as measured by the physician using the P-GSQ where the physician rates his/her level of satisfaction of the treatment and treated area based on 4 satisfaction questions respective to 1. changes to the treated area, 2. skin texture of the treated area, 3. satisfaction with treatment results and 4. likelihood to recommend the treatment as a treatment option.|Change from baseline at Days 90 and 180|Of the 72 enrolled and treated subjects, 69 completed the Day 90 visit and 67 the Day 180 (4 subjects were lost to follow up and one withdrew consent).|||percentage of participants||95% Confidence Interval|Mean
2550507|NCT02832674|Secondary|Subject Global Aesthetic Improvement Scale (S-GAIS)|"A subjective assessment of overall improvement measured by the participant using the SGAIS where the participant rates the appearance of the treated area (submental area) with respect to liftis measured from. the 5-point scale measures from Very much improved to worse."|Change from baseline at Days 90 and 180|of the 72 enrolled and treated subjects, 69 completed the Day 90 visit and 67 completed day 180 (4 subjects were lost to follow up and 1 subject withdrew consent)|||percentage of participants||95% Confidence Interval|Mean
2550508|NCT02832674|Secondary|Physician Global Aesthetic Improvement Scale (P-GAIS)|"A subjective assessment of overall improvement measured by the physician using the PGAIS where the physician rates the appearance of the treated area (submental area) with respect to lift compared to baseline photography at the defined time points. The 5-point scale measures from Very much improved to worse."|Change from baseline at Days 90 and 180|of the 72 enrolled and treated subjects, 69 completed Day 90 and 67 completed the Day 180 visit (4 subjects were lost to follow up and 1 withdrew consent)|||percentage of participants||95% Confidence Interval|Mean
2550509|NCT02832674|Secondary|Percent of Participants Rated as Improved or Not Improved as Scored by the Blinded Rater/Reviewer|Overall improvement of submental lift was determined by a blinded rater panel using before and after photos|Change from baseline to Days 90 and 180|sixty-nine of the 72 enrolled and treated subjects completed visit 5 (Day 90) and 67 completed Visit 6 (Day 180). subjects with non-evaluable images were excluded from the analysis for Day 90 and 180 as applicable|||percentage of participants||95% Confidence Interval|Median
2550510|NCT02832674|Primary|Tissue Lift at the Submental Area Measuring >/= 20 mm2|A >/= 20 mm^2 change from baseline at Day 90 as measured quantitatively using 3D photo images (a calculation).|Change from baseline at Day 90||||percentage of participants||90% Confidence Interval|Mean
2550511|NCT02832375|Secondary|Change From Baseline in Tactile Threshold Immediately After Single Use and on Day 3|Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.|Baseline, after single use (after 5 minutes) and on Day 3|Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n=number of participants evaluated at specific time points for each treatment arms respectively.|||g||Standard Deviation|Mean
2550512|NCT02832375|Secondary|Change From Baseline in Schiff Sensitivity Score After Single Use|Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.|Baseline, after single use (after 5 minutes)|Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is the ITT Population evaluated post treatment single usage for each treatment arms.|||score on a scale||Standard Deviation|Mean
2550513|NCT02832375|Primary|Change From Baseline in Schiff Sensitivity Score on Day 3|Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.|Baseline, Day 3|Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is number of participants from ITT population evaluated on Day 3.|||score on a scale||Standard Deviation|Mean
2550514|NCT02832284|Secondary|Acquisition|iNod maneuvers that acquired specimens of cellular matter for cytology|Intraprocedural|Specimens of cellular matter for cytology per attempt, to acquire cellular matter.|||Specimens of cellular matter for cytolog|Specimens of cellular matter for cytolog||Count of Units
2550515|NCT02832284|Secondary|Access|Lesions accessed where iNod Biopsy Needles were deployed in the target lesion during study maneuvers|Intraprocedural|Lesions accessed per attempt to access lesion|||Lesions access attempts|Lesions access attempts||Count of Units
2550519|NCT02831855|Other Pre-specified|Number of Participants With Abnormal Laboratory Parameters|Abnormality criteria: Hemoglobin (Hb),Hematocrit,Erythrocytes(Ery): <0.8*LLN;Ery. Mean corpuscular volume <0.9*lower limit of normal (LLN), >1.1*upper limit of normal (ULN); Platelets:<0.5*LLN,>1.75*ULN;WBCs:<0.6*LLN,>1.5*ULN; Lymphocytes/WBCs, Neutrophils/WBCs:<0.8*LLN,>1.2* ULN;Basophils,Basophils/WBCs,Eosinophils,Eosinophils/WBCs,Monocytes, Monocytes/WBCs: >1.2*ULN;Prothrombin Time, Prothrombin Intl. Normalized Ratio:>1.1*ULN; ESR:>1.5*ULN; Bilirubin,Direct Bilirubin,Indirect Bilirubin: >1.5*ULN; Aspartate Aminotransferase (AT),Alanine AT,Gamma Glutamyl Transferase,Alkaline Phosphatase:>3.0*ULN; Protein, Albumin: <0.8*LLN, >1.2x ULN; Blood Urea Nitrogen, Creatinine, Triglycerides: >1.3*ULN;HDL Cholesterol:<0.8*LLN;Sodium <0.95*LLN, >1.05*ULN;Potassium, Chloride, Calcium, Bicarbonate: <0.9*LLN, >1.1*ULN; Glucose: <0.6*LLN, >1.5*ULN; Creatine Kinase: >2.0*ULN; Cholesterol:>1.3*ULN;Specific Gravity:<1.003;pH:<4.5; urine glucose,Ketones,urine protein,urine Hb,WBCs Esterase: >=1.|For OL Phase: Baseline up to Week 24; For DB Phase: Week 24 up to Week 48|Overall study safety analysis Set included all participants who received at least one dose of study drug during the study. Overall number of participants analyzed=participants evaluable for this outcome measure.|||Participants|||Count of Participants
2550520|NCT02831855|Other Pre-specified|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 52 (up to 28 days after last dose) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.|For OL Phase: Baseline up to Week 24; For DB Phase: Week 24 up to Week 52 (up to 28 days after last dose)|Overall study safety analysis set included all participants who received at least one dose of study drug during the study.|||Participants|||Count of Participants
2550521|NCT02831855|Secondary|Double Blind Phase: Percentage of Participants Achieving an Improvement of at Least 0.22 Units in HAQ-DI at Weeks 36 and 48|HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities.. There were total of 30 items distributed in these 8 domains. Each item was scored on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities. Percentage of participants with an improvement of at least 0.22 units in HAQ scores from baseline (Day 1) to Weeks 36 and 48 were reported in this outcome measure.|Baseline (Day 1), Weeks 36 and 48|FAS-DB population was analyzed. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points. NRI method was used to impute missing data.|||percentage of participants|||Number
2550522|NCT02831855|Secondary|Double Blind Phase: Change From Randomization in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Scores at Weeks 36 and 48|The FACIT-Fatigue scale was a participant completed questionnaire consisted of 13 items that assessed fatigue. Each item was scored on a scale of 0 (maximum fatigue) to 4 (no fatigue), higher scores indicate less fatigue. Total FACIT-fatigue score was obtained by addition of scores from 13 items, giving a possible overall range from 0 (maximum fatigue) to 52 (no fatigue). Higher FACIT-fatigue scores indicated lower level of fatigue, better participant status.|Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Weeks 36 and 48|FAS-DB population was analyzed. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified time points.|||units on a scale||Standard Error|Least Squares Mean
2550523|NCT02831855|Secondary|Double Blind Phase: Change From Randomization in the European Quality of Life - 5 Dimensions Questionnaire (EQ-5D) Scores at Weeks 36 and 48|EQ-5D was a participant completed instrument designed to assess impact on quality of life in terms of a single utility score in 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. 3 possible answers for mobility: 1=no problem in walking, 2=moderate problems in walking, 3= confined to bed; self-care: 1=no problem, 2=moderate problems, 3= unable to wash/dress; usual activities: 1=no problem, 2=moderate problems, 3= unable to do usual activities; pain and discomfort: 1=no pain or discomfort, 2=moderate pain or discomfort, 3= extreme pain or discomfort; anxiety and depression: 1=not anxious or depressed, 2=moderately anxious or depressed, 3= extremely anxious or depressed. The 5-dimensional systems are converted into a single index utility score between 0 and 1, where higher score indicated a better health state.|Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Weeks 36 and 48|FAS-DB population was analyzed. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified time points.|||units on a scale||Standard Error|Least Squares Mean
2550524|NCT02831855|Secondary|Double Blind Phase: Change From Randomization in the Work Productivity and Activity Impairment (WPAI) Scores at Week 36 and 48|WPAI is 6-question participant rated questionnaire to determine the impact of rheumatoid arthritis and yields 4 types of outcomes: absenteeism (work time missed), presenteeism (impairment while working), work productivity loss (overall work impairment), and daily activity impairment (activity impairment) for a period of 7 days prior to a visit. These 4 outcomes are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Week 36 and 48|FAS-DB was analyzed. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time point.|||percentage impairment||Standard Error|Least Squares Mean
2550657|NCT02829918|Primary|Overall Response Rate (ORR) After 4 Cycles of Treatment|Response in participants with advanced biliary tract cancers receiving nivolumab as a single agent. ORR is defined as complete responses (CR) plus partial responses (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.|16 weeks|46 participants were evaluable for response|||percent|||Number
2550661|NCT02829320|Secondary|Duration of Treatment Interruption Due to Hgb >13 g/dL|Hgb values were used for making decision of treatment interruption. On-therapy Hgb values observed in both scheduled and unscheduled visits were counted. Participants who have no treatment interruption due to Hgb >13.0 g/dL are not included|Up to Week 24|All Treated Subjects Population|||Days||Full Range|Median
2550525|NCT02831855|Secondary|Double Blind Phase: Change From Randomization in the SF-36 Health Survey Component Scores at Weeks 36 and 48|SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: physical functioning, role physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health perception. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of 8 health aspects were summarized aggregated to derive the two 2 component scores PCS and MCS ranging from 0 (worst) to 100 (best), where higher PCS/MCS indicated good health condition.|Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Weeks 36 and 48|FAS-DB was analyzed. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||units on a scale||Standard Error|Least Squares Mean
2550526|NCT02831855|Secondary|Double Blind Phase: Change From Randomization in the Short Form 36 (SF-36) Health Survey 8 Domain Scores at Weeks 36 and 48|SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: physical functioning, role physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health perception. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of 8 health aspects were summarized to derive the 2 component scores (physical component scores [PCS], mental component scores [MCS]) ranging from 0 (worst) to 100 (best), where higher PCS/MCS indicated good health condition.|Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Weeks 36 and 48|FAS-DB was analyzed. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||units on a scale||Standard Error|Least Squares Mean
2550527|NCT02831855|Secondary|Double Blind Phase: Change From Randomization in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 36 and 48|HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities.. There were total of 30 items distributed in these 8 domains. Each item was scored on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.|Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Weeks 36 and 48|FAS-DB was analyzed. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||units on a scale||Standard Error|Least Squares Mean
2550528|NCT02831855|Secondary|Double Blind Phase: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Weeks 36 and 48|Participants with 70% improvement in tender and swollen joint counts and 70% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher scores = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher scores = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability. The improvement was relative to baseline (Day 1).|Baseline (Day 1), Weeks 36 and 48|FAS-DB included all participants who received at least 1 dose of investigational drug during the OL phase, were randomized and received at least 1 dose of the randomized investigational drug regimen during DB phase. NRI method was used to impute missing data.|||percentage of participants|||Number
2550529|NCT02831855|Secondary|Double Blind Phase: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Weeks 36 and 48|Participants with 50% improvement in tender and swollen joint counts and 50% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher scores = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher scores = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability. The improvement was relative to baseline (Day 1).|Baseline (Day 1), Weeks 36 and 48|FAS-DB included all participants who received at least 1 dose of investigational drug during the OL phase, were randomized and received at least 1 dose of the randomized investigational drug regimen during DB phase. NRI method was used to impute missing data.|||percentage of participants|||Number
2550530|NCT02831855|Secondary|Double Blind Phase: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response at Weeks 36 and 48|Participants with 20% improvement in tender and swollen joint counts and 20% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, Health Assessment Questionnaire-Disability Index (HAQ-DI) and CRP. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher scores = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher scores = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability. The improvement was relative to baseline (Day 1).|Baseline (Day 1), Weeks 36 and 48|FAS-DB included all participants who received at least 1 dose of investigational drug during the OL phase, were randomized and received at least 1 dose of the randomized investigational drug regimen during DB phase. NRI method was used to impute missing data.|||percentage of participants|||Number
2550658|NCT02829775|Secondary|Number of Participants With Overall Tumor Response|Tumor response was assessed every 6 months using hematological evaluation or any other appropriate diagnostic techniques, as per standard of care practice. The complete response (CR) and partial response (PR) status were recorded from case report form.|Baseline until disease progression, withdrawal or death, whichever occurred earlier (assessed every 6 months up to approximately 3 years)|All participants who were recruited in the study.|||participants|||Number
2550531|NCT02831855|Secondary|Double Blind Phase: Percentage of Participants With Remission Assessed by SDAI <=3.3 at Weeks 36 and 48|SDAI was calculated from tender and swollen joints using 28 joint count, PtGA, PhyGA and CRP (in mg/dL). PtGA and PhyGA both were assessed on 0-10 cm VAS scale (VAS: scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=11 indicates low disease activity and a score of <=3.3 indicates remission. SDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm) + (CRP in mg/dL).|Weeks 36 and 48|FAS-DB included all participants who received at least 1 dose of investigational drug during the OL phase, were randomized and received at least 1 dose of the randomized investigational drug regimen during DB phase. NRI method was used to impute missing data.|||percentage of participants|||Number
2550532|NCT02831855|Secondary|Double Blind Phase: Percentage of Participants With Remission Assessed by CDAI <=2.8 at Weeks 36 and 48|CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and PhyGA. PtGA and PhyGA both were assessed on 0-10 cm VAS scale (VAS: scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=10 indicated low disease activity and a score of <= 2.8 indicated remission. CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm).|Weeks 36 and 48|FAS-DB included all participants who received at least 1 dose of investigational drug during the OL phase, were randomized and received at least 1 dose of the randomized investigational drug regimen during DB phase. NRI method was used to impute missing data.|||percentage of participants|||Number
2550533|NCT02831855|Secondary|Double Blind Phase: Percentage of Participants With Remission Assessed by DAS28-4 (CRP) <2.6 at Weeks 36 and 48|DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (mg/L) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (CRP) <2.6 implied remission. DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP in mg/l +1) + 0.014*PtGA in mm+ 0.96. Percentage of participants with DAS remission (DAS28-4-CRP<2.6) were reported in this outcome measure.|Weeks 36 and 48|FAS-DB included all participants who received at least 1 dose of investigational drug during the OL phase, were randomized and received at least 1 dose of the randomized investigational drug regimen during DB phase. NRI method was used to impute missing data.|||percentage of participants|||Number
2550534|NCT02831855|Secondary|Double Blind Phase: Percentage of Participants With Remission Assessed by DAS28-4 (ESR) Less Than [<] 2.6 at Weeks 36 and 48|DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (ESR) <2.6 implied remission. DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*In(ESR in mm/hour) + 0.014*PtGA in mm. Percentage of participants with DAS remission (DAS28-4-ESR<2.6) were reported in this outcome measure.|Weeks 36 and 48|FAS-DB included all participants who received at least 1 dose of investigational drug during the OL phase, were randomized and received at least 1 dose of the randomized investigational drug regimen during DB phase. NRI method was used to impute missing data.|||percentage of participants|||Number
2550535|NCT02831855|Secondary|Double Blind Phase: Percentage of Participants With Remission Assessed by American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean at Weeks 36 and 48|ACR-EULAR Boolean remission was when a participant satisfied all of the following: tender joint count, swollen joint count (both based on a 28-joint assessment), CRP (in mg/dL), and PtGA (VAS: 0 cm [very well] to 10 cm [worst], higher scores indicated worse health condition) and all scores were <=1.|Weeks 36 and 48|FAS-DB included all participants who received at least 1 dose of investigational drug during the OL phase, were randomized and received at least 1 dose of the randomized investigational drug regimen during DB phase. NRI method was used to impute missing data.|||percentage of participants|||Number
2550536|NCT02831855|Secondary|Double Blind Phase: Percentage of Participants With LDA Assessed by SDAI <=11 at Weeks 36 and 48|SDAI was calculated from tender and swollen joints using 28 joint count, PtGA, PhyGA and CRP (in mg/dL). PtGA and PhyGA both were assessed on 0-10 cm VAS scale (VAS: scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=11 indicated low disease activity and a score of <=3.3 indicated remission. SDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm) + (CRP in mg/dL).|Weeks 36 and 48|FAS-DB included all participants who received at least 1 dose of investigational drug during the OL phase, were randomized and received at least 1 dose of the randomized investigational drug regimen during DB phase. NRI method was used to impute missing data.|||percentage of participants|||Number
2550537|NCT02831855|Secondary|Double Blind Phase: Percentage of Participants With LDA Assessed by CDAI <=10 at Weeks 36 and 48|CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and PhyGA. PtGA and PhyGA both were assessed on 0-10 cm VAS scale (VAS: scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=10 indicated low disease activity and a score of <= 2.8 indicated remission. Percentage of participants with CDAI <=10 were reported. CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm).|Weeks 36 and 48|FAS-DB included all participants who received at least 1 dose of investigational drug during the OL phase, were randomized and received at least 1 dose of the randomized investigational drug regimen during DB phase. NRI method was used to impute missing data.|||percentage of participants|||Number
2550662|NCT02829320|Secondary|Number of Participants With Frequency of Dose Adjustments|Dose adjustment algorithm was used which was based on Hgb values at scheduled visits. Hgb values measured at unscheduled visits were not included. For dose adjustments frequency, the number of participants were provided by the number of dose adjustments (i.e. zero, one, two, three, four, and five or more).|Up to Week 24|All Treated Subjects Population|||Participants|||Count of Participants
2550538|NCT02831855|Secondary|Double Blind Phase: Percentage of Participants With LDA Assessed by DAS28-4 (CRP) <=3.2 at Weeks 36 and 48|DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (mg/L) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (CRP) <2.6 implied remission. DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP in mg/L +1) + 0.014*PtGA in mm+ 0.96; ln = natural logarithm, sqrt = square root of.|Weeks 36 and 48|FAS-DB included all participants who received at least 1 dose of investigational drug during the OL phase, were randomized and received at least 1 dose of the randomized investigational drug regimen during DB phase. NRI method was used to impute missing data.|||percentage of participants|||Number
2550539|NCT02831855|Secondary|Double Blind Phase: Percentage of Participants With Low Disease Activity (LDA) Assessed by DAS28-4 (ESR) Less Than or Equal to (<=) 3.2 at Weeks 36 and 48|DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicated worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (ESR) <2.6 implied remission. DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*In(ESR in mm/hour) + 0.014*PtGA in mm; ln = natural logarithm, sqrt = square root of.|Weeks 36 and 48|FAS-DB included all participants who received at least 1 dose of investigational drug during the OL phase, were randomized and received at least 1 dose of the randomized investigational drug regimen during DB phase. Non-responder imputation (NRI) method was used to impute missing data.|||percentage of participants|||Number
2550540|NCT02831855|Secondary|Double Blind Phase: Change From Randomization in Simplified Disease Activity Index (SDAI) at Weeks 36 and 48|SDAI was calculated from tender and swollen joints using 28 joint count, PtGA, PhyGA and CRP (in mg/dL). PtGA and PhyGA both were assessed on 0-10 cm VAS scale (VAS: scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=11 indicates low disease activity and a score of <=3.3 indicates remission. SDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm) + (CRP in mg/dL).|Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Weeks 36 and 48|FAS-DB was analyzed. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||units on a scale||Standard Error|Least Squares Mean
2550541|NCT02831855|Secondary|Double Blind Phase: Change From Randomization in Clinical Disease Activity Index (CDAI) at Weeks 36 and 48|CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and physician global assessment of arthritis (PhyGA). PtGA and PhyGA both were assessed on 0-10 centimeter (cm) VAS scale (VAS: scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=10 indicated low disease activity and a score of <= 2.8 indicated remission. CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm).|Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Weeks 36 and 48|FAS-DB was analyzed. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||units on a scale||Standard Error|Least Squares Mean
2550542|NCT02831855|Secondary|Double Blind Phase: Change From Randomization in DAS28-4 (C-reactive Protein [CRP]) at Weeks 36 and 48|DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (milligrams per liter [mg/L]) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) <= 3.2 implied low disease activity and > 3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (CRP) < 2.6 implied remission. DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP in mg/L +1) + 0.014*PtGA in mm+ 0.96; ln = natural logarithm, sqrt = square root of.|Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Weeks 36 and 48|FAS-DB was analyzed. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||units on a scale||Standard Error|Least Squares Mean
2550543|NCT02831855|Secondary|Double Blind Phase: Change From Randomization in DAS28-4 ESR at Week 36|DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA on a 100 millimeter (mm) VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (ESR) less than (<) 2.6 implied remission. DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*In(ESR in mm/hour) + 0.014*PtGA in mm; ln = natural logarithm, sqrt = square root of.|Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Week 36|FAS-DB included all participants who received at least 1 dose of investigational drug during the OL phase, were randomized and received at least 1 dose of the randomized investigational drug regimen during DB phase. Overall number of participants analyzed=participants evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2550659|NCT02829775|Primary|Number of Participants With Serious Adverse Events (SAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; Life-threatening experience (immediate risk of dying); Persistent or significant disability or incapacity; and congenital anomaly.|Baseline up to approximately 3 years|All participants who were recruited in the study.|||participants|||Number
2550544|NCT02831855|Primary|Double Blind Phase: Change From Randomization in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (Erythrocyte Sedimentation Rate [ESR]) at Week 48|DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, ESR (millimeters per hour [mm/hr]) and participant global assessment of arthritis (PtGA) on a 100 millimeter (mm) visual analog scale (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (ESR) less than (<) 2.6 implied remission. DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*In(ESR in mm/hour) + 0.014*PtGA in mm; ln = natural logarithm, sqrt = square root of.|Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Week 48|Double-Blind Period Full Analysis Set (FAS-DB) included all participants who received at least 1 dose of investigational drug during the OL phase, were randomized and received at least 1 dose of the randomized investigational drug regimen during DB phase. Overall number of participants analyzed=participants evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2550545|NCT02831764|Secondary|Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48|EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value and change from Baseline=post-dose value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|Baseline (Day 1) and Weeks 4, 24, 48|ITT-E Population.|||Scores on a scale||Standard Error|Least Squares Mean
2550546|NCT02831764|Secondary|Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24 48|EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment and change from Baseline=post-dose value minus Baseline value. Only those participants available at the specified time points were analyzed.|Baseline (Day 1) and Weeks 4, 24, 48|ITT-E Population. (represented by n=x in the category titles).|||Scores on a scale||Standard Error|Least Squares Mean
2550547|NCT02831764|Secondary|Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups|CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only.|Baseline (Day 1) and Week 24|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Cells/mm^3||Standard Error|Mean
2550548|NCT02831764|Secondary|Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups|CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the inidicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from Analysis of Covariance (ANCOVA) model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only.|Baseline (Day 1) and Week 48|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Cells/mm^3||Standard Error|Least Squares Mean
2550549|NCT02831764|Secondary|Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48|Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3 for group-1), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian and other).|Week 48|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Percentage of participants|||Number
2550660|NCT02829463|Primary|Infrapatellar Fat Pad Volume in MRI||collect the data within 24 hours after the subjects did the MRI||||mm^3||Standard Deviation|Mean
2550550|NCT02831764|Secondary|Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24|Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200 cells/mm^3, >200 cells/mm^3 for group-1), Baseline HIV-1 RNA (<=100000, >100000 c/mL) and Race (White, African American/African heritage, Asian other).|Week 24|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Percentage of participants|||Number
2550551|NCT02831764|Secondary|Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48|Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Weeks 24 and 48 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 48 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values.|Weeks 24 and 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|||Percentage of participants|||Number
2550552|NCT02831764|Secondary|Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48|Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value). Lipid last observation carried forwardd (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Participants on lipid-lowering agents at Baseline were excluded.|Baseline (Day 1) and at Weeks 24, 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Percentage change||Standard Deviation|Mean
2550553|NCT02831764|Secondary|Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48|Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value is defined as the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value).|Baseline and at Weeks 24, 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Percentage change||Standard Deviation|Mean
2550554|NCT02831764|Secondary|Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48|Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value.|Baseline and at Weeks 24, 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Nanomoles per Liter (nmol/L)||Standard Error|Least Squares Mean
2550555|NCT02831764|Secondary|Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48|Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value.|Baseline (Day 1) and at Weeks 24, 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Micrograms per Liter (ug/L)||Standard Error|Mean
2550564|NCT02831764|Secondary|Number of Participants With AEs by Maximum Severity Grades|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. Analyses presented herein used a data cut-off date of 22 May 2018 (for Week 48 database freeze), i.e. may include data collected after a participant's Week 48 visit.|Up to Week 48|Safety Population|||Participants|||Count of Participants
2552288|NCT02796963|Secondary|Number of Men Reporting Using Weibo in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing||From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
2550556|NCT02831764|Secondary|Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48|Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Geometric mean ratio and 95% CI of geometric mean ratio have been presented. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor.|Baseline and Weeks 24, 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Ratio||95% Confidence Interval|Geometric Mean
2550557|NCT02831764|Secondary|Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48|Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|Baseline and at Weeks 24, 48|Safety Population.|||Micromoles per Liter (umol/L)||Standard Deviation|Mean
2550558|NCT02831764|Secondary|Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48|Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI (GFR-cystatin C adjusted) and Serum or Plasma GFR from creatinine adjusted using CKD-EPI. Baseline value is the latest pre-dose Assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor.|Baseline and at Weeks 24, 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Milliliter/minute/1.73 meter^2||Standard Error|Mean
2550559|NCT02831764|Secondary|Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48|Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C and Serum RBP. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor.|Baseline and at Weeks 24, 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Milligrams per Liter (mg/L)||Standard Error|Least Squares Mean
2550560|NCT02831764|Secondary|Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants who discontinued treatment due to AEs have been reported. Analyses presented herein used a data cut-off date of 19 January 2018 and 22 May 2018, respectively, for the Week 24 database freeze and Week 48 database freeze), i.e. may include data collected after a participant's Week 24 or 48 visit, respectively.|Weeks 24 and 48|Safety Population|||Participants|||Count of Participants
2550561|NCT02831764|Secondary|Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities|Blood samples were collected up to Week 48 for assessment of Alanine Aminotransferase (ALT), Aspartate aminotransferase (AST), Albumin, Alkaline Phosphatase (ALP), Bilirubin, Carbon dioxide (CO2), Cholesterol, Creatine kinase (CPK), Creatinine, Direct Bilirubin, Glomerular filtration rate (GFR), Hypercalcemia, Hyperglycemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycemia, Hypokalemia and Hyponatremia, Low density lipid (LDL) Cholesterol, Lactate Dehydrogenase, Lipase and Phosphate. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Only those participants with maximum post-Baseline emergent chemistry toxicities in any of the chemistry parameters have been presented.|Up to Week 48|Safety Population|||Participants|||Count of Participants
2550562|NCT02831764|Secondary|Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities|Blood samples were collected up to Week 48 for assessment of platelet count, neutrophils, hemoglobin, and Leukocytes. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Only those participants with maximum post-Baseline emergent hematology toxicities in any of the listed hematology parameters have been presented.|Up to Week 48|Safety Population|||Participants|||Count of Participants
2550563|NCT02831764|Secondary|Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5. (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with drug related AEs and drug related AEs by by maximum grade have been presented. Analyses presented herein used a data cut-off date of 22 May 2018 (for Week 48 database freeze), i.e. may include data collected after a participant's Week 48 visit.|Up to Week 48|Safety Population|||Participants|||Count of Participants
2572007|NCT02512393|Primary|Heat Pain Threshold|Quantitative Sensory Testing (QST) by using heat pain delivered by using thermal probe on the skin.|baseline||||Celsius||Standard Deviation|Mean
2550565|NCT02831764|Secondary|Number of Participants With Any Adverse Event (AE) and Serious AE (SAE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Safety Population was used which comprised of all participants who received at least one dose of study treatment. Analyses presented herein used a data cut-off date of 22 May 2018 (for Week 48 database freeze), i.e. may include data collected after a participant's Week 48 visit.|Up to Week 48|Safety Population|||Participants|||Count of Participants
2550566|NCT02831764|Secondary|Number of Participants With Treatment-emergent Phenotypic Resistance|Number of participants, who meet CVW criteria, with treatment emergent phenotypic resistance to INSTI and/or NRTI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results were interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drugs (Abacavir [ABC], elvitegravir [EGV], raltegravir [RAL], zidovudine [AZT], stavudine [D4T], didanosine [DDI]), emtricitabine [FTC], tenofovir disiproxil fumarate [TDF]). Partially sensitive and resistant cells were considered resistant in this analysis. Number of participants with phenotype at time of CVW by phenotypic cut-off at or prior to Week 48 have been presented. The Viral Phenotypic Population comprised of all participants in the ITT-E population who have available on-treatment phenotypic resistance data. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|Up to Week 48|Viral Phenotypic Population|||Participants|||Count of Participants
2550567|NCT02831764|Secondary|Number of Participants With Treatment-emergent Genotypic Resistance|Number of participants, who meet confirmed virologic withdrawal (CVW) criteria, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI) and/or Nucleoside reverse transcriptase inhibitor (NRTI) was summarized. The Viral Genotypic Population comprised of all participants in the ITT-E population who have available on-treatment genotypic resistance data.|Up to Week 48|Viral Genotypic Population|||Participants|||Count of Participants
2550568|NCT02831764|Secondary|Number of Participants With HIV-1 Disease Progression|HIV-associated conditions were recorded during the study and was assessed according to the 2014 Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. Disease progressions summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrolment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrolment to Death.|Up to Week 48|ITT-E Population|||Participants|||Count of Participants
2550569|NCT02831764|Secondary|Changes From Baseline in CD4+ Cell Counts at Week 24 and 48|CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted least mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor.|Baseline and Weeks 24, 48|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Cells/mm^3||Standard Error|Least Squares Mean
2550570|NCT02831764|Secondary|CD4+ Cell Counts at Weeks 24 and 48|CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry.|Weeks 24 and 48|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Cells/mm^3||Standard Deviation|Mean
2550571|NCT02831764|Secondary|Time to Viral Suppression (HIV-1 RNA <50 c/mL)|Time of viral suppression is defined as the first viral load value <50 c/mL. Nonparametric Kaplan-Meier method was performed. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Confidence Interval (CI) was estimated using the Brookmeyer-Crowley method. Median along with first Quartile and third Quartile have been presented.|Up to Week 48|ITT-E Population|||Days||Inter-Quartile Range|Median
2550572|NCT02831764|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 24|Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights.|Week 24|ITT-E Population|||Percentage of participants||95% Confidence Interval|Number
2550573|NCT02831764|Primary|Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48|Percentage of participants with HIV-1 RNA<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights. Intent-To-Treat Exposed (ITT-E) Population was used which comprised of all randomized participants who received at least one dose of study treatment.|Week 48|ITT-E Population|||Percentage of participants||95% Confidence Interval|Number
2573797|NCT02491359|Secondary|Use of Additional Systemic Immune-suppressive Therapies|Addition of therapy after carfilzomib constitutes failure, could occur at any time from baseline to 12mo.|1 year||||participants|||Number
2550574|NCT02831673|Secondary|Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24 48|EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value and change from Baseline=post-dose value minus Baseline value.|Baseline (Day 1) and Weeks 4, 24, 48|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Scores on a scale||Standard Error|Mean
2550575|NCT02831673|Secondary|Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48|EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. Baseline was the latest pre-dose assessment and change from Baseline=post-dose value minus Baseline value.|Baseline and Weeks 4, 24, 48|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Scores on a scale||Standard Error|Mean
2550576|NCT02831673|Secondary|Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups|CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age, Gender, and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only.|Baseline (Day 1) and Week 24|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Cells per cubic millimeter||Standard Error|Mean
2550577|NCT02831673|Secondary|Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups|CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from Analysis of Covariance (ANCOVA) model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only.|Baseline (Day 1) and Week 48|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Cells per cubic millimeter||Standard Error|Mean
2550578|NCT02831673|Secondary|Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48|Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200, >200), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian, Other).|Week 48|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Percentage of participants|||Number
2550579|NCT02831673|Secondary|Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24|Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (<35, 35 to <50, >=50 years); gender (males and females), Baseline CD4+ cell count (<=200, >200), Baseline HIV-1 RNA (<=100000, >100000) and Race (White, African American/African H., Asian, Other).|Week 24|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Percentage of participants|||Number
2550634|NCT02829944|Secondary|Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale|Patients contacted over the phone completed screening with the EPDS, on a scale of 0-30. A score of over 13 indicate risk for postpartum depression|8 weeks|Unable to make contact with 9 participants in the Placebo group and 13 participants in the Ropivacaine group.|||units on a scale||Inter-Quartile Range|Median
2550635|NCT02829944|Secondary|Number of Subjects With Chronic Pain|Phone interview asking patient about presence of pain at incision site|6 months|28 participants in each group (Placebo and Ropivacaine) did not complete the interview.|||Participants|||Count of Participants
2550580|NCT02831673|Secondary|Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48|Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Weeks 24 and 48 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 48 or those who had Baseline lipids-lowering agents are not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values.|Up to Week 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Percentage of participants|||Number
2550581|NCT02831673|Secondary|Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48|Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value).|Baseline (Day 1) and at Weeks 24, 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Percentage change||Standard Deviation|Mean
2550582|NCT02831673|Secondary|Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48|Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value is defined as the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by ([post-dose visit value minus Baseline value] divided by Baseline value).|Baseline (Day 1) and at Weeks 24, 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Percentage change||Standard Deviation|Mean
2550583|NCT02831673|Secondary|Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48|Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor.|Baseline and at Weeks 24, 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Nanomoles per Liter (nmol/L)||Standard Error|Mean
2550584|NCT02831673|Secondary|Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48|Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor.|Baseline and at Weeks 24, 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Micrograms per Liter (ug/L)||Standard Error|Mean
2550585|NCT02831673|Secondary|Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48|Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value is defined as the latest pre-dose assessment. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Statistical analysis of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios. Estimated ratio of geometric means (each visit over Baseline) and 95% confidence interval (CI) have been presented.|Baseline and at Weeks 24, 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Ratio||95% Confidence Interval|Geometric Mean
2550586|NCT02831673|Secondary|Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48|Blood and/or urine were collected to perform evaluation of renal inflammation biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor.|Baseline and at Weeks 24, 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Micromoles per Liter (umol/L)||Standard Error|Mean
2552289|NCT02796963|Secondary|Number of Men Reporting Being Tested for Syphilis in the Last 3 Months Post-intervention||From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
2550587|NCT02831673|Secondary|Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48|Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI (GFR-cystatin C adjusted)and Serum or Plasma GFR from creatinine adjusted using CKD-EPI. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor.|Baseline and at Weeks 24, 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Milliliter/minute/1.73*meter^2||Standard Error|Mean
2550588|NCT02831673|Secondary|Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48|Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers which included Serum Cystatin C and Serum Retinol Binding Protein (RBP). Baseline value is the latest pre-dose assessment. Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, baseline plasma HIV-1 RNA (factor), baseline CD4+ cell count (factor), age, sex (factor), race (factor), presence of diabetes mellitus (factor), presence of hypertension (factor), baseline biomarker value, treatment and visit interaction, and baseline biomarker value and visit interaction; with visit as the repeated factor.|Baseline and at Weeks 24, 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Milligrams per Liter (mg/L)||Standard Error|Mean
2550589|NCT02831673|Secondary|Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Data cut-off dates for analysis at Week 24 and Week 48 were 19-Jan-2018 and 22-May-2018 respectively. Number of participants who discontinued treatment due to AEs have been reported.|Up to Week 48|Safety Population|||Participants|||Count of Participants
2550590|NCT02831673|Secondary|Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities|Blood samples were collected up to Week 48 for assessment of Alanine Aminotransferase (ALT), Aspartate aminotransferase (AST), Creatinine, Glucose, Potassium, Sodium, Chloride, Calcium, Total carbon dioxide (CO2), Alkaline phosphatase (ALP), Phosphate, Total bilirubin, Total protein, Albumin, Creatine phosphokinase (CPK), Creatinine clearance,Glomerular filtration rate (GFR), Total cholesterol, High density lipoprotein (HDL), Low density lipoprotein (LDL), Triglyceride and Lipase. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent chemistry toxicities in any of the chemistry parameters have been presented.|Up to Week 48|Safety Population|||Participants|||Count of Participants
2550591|NCT02831673|Secondary|Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities|Blood samples were collected up to Week 48 for assessment of hematology parameters to assess any abnormality per toxicity scales for platelet count, neutrophils, hemoglobin. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented.|Up to Week 48|Safety Population|||Participants|||Count of Participants
2550592|NCT02831673|Secondary|Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with drug related AEs and drug related AEs by maximum grade have been presented.|Up to Week 48|Safety Population|||Participants|||Count of Participants
2550593|NCT02831673|Secondary|Number of Participants With AEs by Their Severity Grades|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.|Up to Week 48|Safety Population|||Participants|||Count of Participants
2550594|NCT02831673|Secondary|Number of Participants With Any Adverse Event (AE) and Serious AE (SAE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Safety Population was used which comprised of all participants who received at least one dose of study treatment.|Up to Week 48|Safety Population|||Participants|||Count of Participants
2550636|NCT02829944|Secondary|Number of Subjects With Chronic Pain|Phone interview asking patient about presence of pain at incision site|8 weeks|Unable to make contact with 9 participants in the Placebo group and 13 participants in the Ropivacaine group.|||Participants|||Count of Participants
2550595|NCT02831673|Secondary|Number of Participants With Treatment-emergent Phenotypic Resistance|Number of participants, who meet CVW criteria, with treatment emergent phenotypic resistance to INSTI and/or NRTI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. Number of participants with phenotype at time of CVW by phenotypic cut-off at or prior to Week 48 have been presented. The Viral Phenotypic Population comprised of all participants in the ITT-E population who have available on-treatment phenotypic resistance data.|Up to Week 48|Viral Phenotypic Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Participants|||Count of Participants
2550596|NCT02831673|Secondary|Number of Participants With Treatment-emergent Genotypic Resistance|Number of participants, who meet confirmed virologic withdrawal (CVW) criteria, with treatment emergent phenotypic resistance to Integrase strand transfer inhibitor (INSTI) and/or Nucleoside reverse transcriptase inhibitor (NRTI) was summarized. The Viral Genotypic Population comprised of all participants in the ITT-E population who have available on-treatment genotypic resistance data.|Up to Week 48|Viral Genotypic Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2550597|NCT02831673|Secondary|Number of Participants With HIV-1 Disease Progression|HIV-associated conditions were recorded during the study and was assessed according to the 2014 Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. Disease progression summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrolment to Stage 3 event; CDC Category Stage 2 at enrolment to Stage 3 event; CDC Category Stage 3 at enrolment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrolment to Death.|Up to Week 48|ITT-E Population|||Participants|||Count of Participants
2550598|NCT02831673|Secondary|Changes From Baseline in CD4+ Cell Counts at Week 24 and 48|CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the the latest pre-dose assessment (Day 1). Change from Baseline was defined as post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor.|Baseline (Day 1) and Weeks 24, 48|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Cells per cubic millimeter||Standard Error|Mean
2550599|NCT02831673|Secondary|CD4+ Cell Counts at Weeks 24 and 48|CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry.|Weeks 24 and 48|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Cells per cubic millimeter (cells/mm^3)||Standard Deviation|Mean
2550600|NCT02831673|Secondary|Time to Viral Suppression (HIV-1 RNA <50 c/mL)|Time of viral suppression is defined as the first viral load value <50 c/mL. Nonparametric Kaplan-Meier method was performed. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Confidence Interval (CI) was estimated using the Brookmeyer-Crowley method. Median along with interquartile range (first Quartile and third Quartile) have been presented.|Up to Week 48|ITT-E Population|||Days||Inter-Quartile Range|Median
2550601|NCT02831673|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24|Percentage of participants with HIV-1 RNA<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel weights.|Week 24|ITT-E Population|||Percentage of participants||95% Confidence Interval|Number
2550602|NCT02831673|Primary|Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48|Percentage of participants with HIV-1 RNA<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights. Intent-To-Treat Exposed (ITT-E) Population was used which comprised of all randomized participants who receive at least one dose of study treatment.|Week 48|ITT-E Population|||Percentage of participants||95% Confidence Interval|Number
2550603|NCT02831660|Primary|Percentage of Subjects With Drug-related Adverse Events|Percentage of subjects with drug-related adverse events is presented|from first drug administration until 5 days after last drug administration, up to 6 days.|Treated Set|||Percentage of participants|||Number
2550604|NCT02831569|Secondary|Assessment of Pain Due to Low Back Pain, Scapulohumeral Periarthritis or Cervico-omo-brachial Syndrome After 2 Weeks of Treatment|"The outcome measure presents percentage of patients who showed marked improvement or moderate improvement in low back pain and/or scapulohumeral periarthritis and/or cervico-omo-brachial syndrome after 2 weeks of treatment."|Post 2 weeks.|Full Analysis Set [FAS]: The analysis set included patients who received at least one dose of the trial medication during the trial period and have efficacy data at baseline and after the start of treatment. Efficacy analysis was performed on FAS.|||Percentage of participants|||Number
2550605|NCT02831569|Primary|Percentage of Patients With Drug-related Adverse Events [AEs]|The outcome measure presents percentage of patients with drug-related AEs.|Up to 3 weeks.|Treated Set [TS]: The analysis set included patients who received at least one dose of the trial medication during the trial period. Safety analysis was performed on TS.|||Percentage of participants|||Number
2550606|NCT02831387|Secondary|Change From Baseline (Visit 2) to Day 15 (Visit 3) in the Subject-reported Dry Eye Symptom Score.|Dry Eye symptoms were obtained using the Symptom Assessment in Dry Eye (SANDE) questionnaire. The questionnaire utilizes separate Visual Analog Scales (VAS) for the frequency and the Severity of symptoms. The scores range from 0 to 100 where 0 = Rarely or Very Mild, and 100 = All the Time or Very Severe for the Frequency and Severity of the symptoms, respectively. The Global Score as reported in the Primary Outcome is obtained by taking the square root of the product of the frequency score multiplied by the severity score. A negative change from baseline indicates improvement.|Baseline to Day 15|The modified Intent-to-Treat Population (mITT) include all randomized subjects who have at least a baseline and one post-baseline symptom questionnaire part 1 assessment. This is the primary population for efficacy analyses and subjects are analyzed based on their randomized treatment.|||units on a scale||Standard Deviation|Mean
2550607|NCT02831387|Secondary|Number of Participants With at Least 20% Improvement in Symptoms From Baseline to Day 29|Improvement in symptoms was evaluated using the Symptom Assessment in Dry Eye (SANDE) questionnaire. The questionnaire utilizes separate Visual Analog Scales (VAS) for the frequency and the Severity of symptoms. The scores range from 0 to 100 where 0 = Rarely or Very Mild, and 100 = All the Time or Very Severe for the Frequency and Severity of the symptoms, respectively. The Global Score is obtained by taking the square root of the product of the frequency score multiplied by the severity score. Lower scores indicate improvement in symptoms.|Baseline to Day 29|The modified Intent-to-Treat Population (mITT) include all randomized subjects who have at least a baseline and one post-baseline symptom questionnaire part 1 assessment. For this outcome, only participants that completed the treatment were analyzed|||Participants|||Count of Participants
2550608|NCT02831387|Secondary|Change From Baseline to Day 29 in Lissamine Green Staining of the Conjunctiva.|Conjunctival staining was performed to grade the conjunctival epithelial cell injury as measured by Lissamine Green using slit-lamp examination. The staining was graded with the NEI scale. The bulbar conjunctival surface is divided into 6 regions (1, Temporal; 2 Temporal Superior; 3, Temporal Inferior; 4, Nasal Superior; 5, Nasal Inferior; 6, Nasal). The scores for each of these 6 regions ranged from 0 to 3 (0=no staining; 1=staining with low density; 2=staining with moderate density; 3=staining with severe density). The total staining score (sum of all regions, maximal score =18) is reported. A negative change from baseline indicates improvement.|Baseline to Day 29|The modified Intent-to-Treat Population (mITT) include all randomized subjects who have at least a baseline and one post-baseline symptom questionnaire part 1 assessment. This is the primary population for efficacy analyses and subjects are analyzed based on their randomized treatment.|||units on a scale||Standard Deviation|Mean
2550609|NCT02831387|Secondary|Change From Baseline to Day 29 in Fluorescein Staining of the Cornea.|Corneal staining was performed to grade the corneal epithelial cell injury as measured by fluorescence using slit lamp examination. The staining was graded with the NEI scale. The corneal surface is divided into 5 corneal regions (1, Central; 2, Inferior; 3, Nasal; 4, Temporal; 5, Superior). The scores for each of these 5 regions ranged from 0 to 3 (0=no staining; 1=staining with low density; 2=staining with moderate density; 3=staining with severe density). The total staining score (sum of all regions, maximal score =15) is reported. A negative change from baseline indicates improvement.|Baseline to Day 29|The modified Intent-to-Treat Population (mITT) include all randomized subjects who have at least a baseline and one post-baseline symptom questionnaire part 1 assessment. This is the primary population for efficacy analyses and subjects are analyzed based on their randomized treatment.|||units on a scale||Standard Deviation|Mean
2550610|NCT02831387|Secondary|Change From Baseline (Visit 2) to Day 29 in Symptom Severity Scores|Dry Eye symptom severity was obtained using the Symptom Assessment in Dry Eye (SANDE) questionnaire. The questionnaire utilizes a 100 mm horizontal Visual Analog Scales (VAS). The scores range from 0 to 100 where 0 = Very Mild and 100 = Very Severe. A negative change from baseline indicates improvement.|Baseline to Day 29|The modified Intent-to-Treat Population (mITT) include all randomized subjects who have at least a baseline and one post-baseline symptom questionnaire part 1 assessment. This is the primary population for efficacy analyses and subjects are analyzed based on their randomized treatment.|||units on a scale||Standard Deviation|Mean
2550611|NCT02831387|Secondary|Change From Baseline (Visit 2) to Day 29 in Symptom Frequency Scores|Dry Eye symptom frequency was obtained using the Symptom Assessment in Dry Eye (SANDE) questionnaire. The questionnaire utilizes a 100 mm horizontal Visual Analog Scale (VAS). The scores range from 0 to 100 where 0 = Rarely and 100 = All the Time. A negative change from baseline indicates improvement.|Baseline to Day 29|The modified Intent-to-Treat Population (mITT) include all randomized subjects who have at least a baseline and one post-baseline symptom questionnaire part 1 assessment. This is the primary population for efficacy analyses and subjects are analyzed based on their randomized treatment.|||units on a scale||Standard Deviation|Mean
2550612|NCT02831387|Primary|Change From Baseline (Visit 2) to Day 29 (Visit 4) in the Subject-reported Dry Eye Symptom Questionnaire.|Dry Eye symptoms were obtained using the Symptom Assessment in Dry Eye (SANDE) questionnaire. The questionnaire utilizes separate Visual Analog Scales (VAS) for the frequency and the Severity of symptoms. The scores range from 0 to 100 where 0 = Rarely or Very Mild, and 100 = All the Time or Very Severe for the Frequency and Severity of the symptoms, respectively. The Global Score as reported in the Primary Outcome is obtained by taking the square root of the product of the frequency score multiplied by the severity score. Negative change from baseline indicates improvement.|Baseline to Day 29|The modified Intent-to-Treat Population (mITT) include all randomized subjects who have at least a baseline and one post-baseline symptom questionnaire part 1 assessment. This is the primary population for efficacy analyses and subjects are analyzed based on their randomized treatment.|||units on a scale||Standard Deviation|Mean
2550613|NCT02830880|Secondary|Number of Deaths|The number of deaths that have occurred was assessed at the end of study.|End of Study (up to 1 year)||||Participants|||Count of Participants
2550614|NCT02830880|Primary|Number of Participants With a Clinical Response Assessed by Bone Scan|Each patient underwent 99mTc MDP whole body bone scanning at baseline, and after the 6th cycle. Bone scans findings were interpreted based on recommendations from Prostate Cancer Clinical Trial Working Group 3 (PCCTWG3) using a specialized Bone Scan Assessment Tool. The change in disease response after cycle 6 compared to the baseline assessment is presented here.|Baseline, After Cycle 6 (Week 17)|This analysis includes participants who completed the study.|||Participants|||Count of Participants
2550615|NCT02830880|Primary|Number of Participants Responding to Treatment Assessed by CT Scan|"A CT will be used to assess response to treatment. Treatment response will be reported as follows:~Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.~Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.~Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm."|After Cycle 6 (Week 17)|This analysis includes participants completing the study.|||Participants|||Count of Participants
2550616|NCT02830880|Primary|Number of Participants Responding to Treatment Assessed by MRI|"Participants will have an MRI or a CT scan to assess response to treatment. Treatment response will be reported as follows:~Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Complete Response Unknown (CRU)~Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.~Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.~Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm."|Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)|Data were not collected for this outcome measure as all participants had a CT scan rather than an MRI to assess response to treatment.||||||
2550617|NCT02830880|Primary|Prostate Specific Antigen Level|Prostate Specific Antigen (PSA) serum biomarker will be used to assess response to treatment. PSA level will be collected via blood draw. While a formal cutpoint signifying prostate cancer is not generally used as PSA levels vary between men, in general, higher PSA levels indicate prostate cancer.|Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)|This analysis includes participants completing the study visits.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2550618|NCT02830880|Primary|Percent Change Assessed by FACBC PET Scan|Clinical response will be assessed with FACBC PET imaging. The same measurements of the lesions and background structures will be undertaken at baseline and post-therapy scan. The researchers utilized the following parameters to follow response to therapy: maximum standardized uptake value (SUVmax) of most intense lesion each of bone and node, sum and mean SUVmax of up to 5 index lesions for each of bone and node of most intense lesion each of bone and node of the 5 index lesions for each of bone and node. SUVmax measures uptake of the radiotracer by malignant cells. Percent change after therapy, compared to baseline, was calculated and a positive percent increase indicates greater uptake of FACBC by cancer cells.|Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)|This analysis includes participants completing the study visits used in each change from baseline determination.|||percent change of SUVmax||Standard Deviation|Mean
2550619|NCT02830087|Secondary|Need for Manipulation Under Anesthesia|Number of participants that needed a manipulation under anesthesia was necessary within 12 weeks|6-week follow-up through 12-week follow-up|No data collected||||||
2550620|NCT02830087|Secondary|Quadriceps Strength|"Six Point Strength Scale 0 - No muscle movement~-Muscle movement, without movement at the joint~-Movement at the joint, but not against gravity~-Movement against gravity, but not against resistance~-Movement against resistance, but less than full strength~-Full Strength~Higher scores denotes better outcome"|2-week follow-up through 12-week follow-up|data not collected for all participants|||score on a scale|||Number
2550621|NCT02830087|Secondary|Ability to Ambulate|Distance Walked in Feet|Postoperative Day 1 through Postoperative Day 2|data not collected for all participants|||Feet|||Number
2550622|NCT02830087|Secondary|Need for Revision of Total Knee Arthroplasty|Number of participants that needed a revision was necessary within one year|One Year Follow-up|No data collected||||||
2550623|NCT02830087|Secondary|Number of Participants With Wound Healing Issues|Any wound issues including blisters, wound drainage, thigh bruising, significant erythema, decreased peripheral pulse, evidence of decreased distal perfusion, or decreased distal sensation|Postoperative Day 1 through 12 week follow-up||||Participants|||Count of Participants
2550624|NCT02830087|Secondary|Intra-operative Bloodlessness|"four-point scale:~1 = bloodless~2 = nearly bloodless, some bleeding~3 = bloody, tourniquet no better than not using~4 = venous tourniquet, tourniquet making things worse~Higher scores denotes worse outcome"|Intraoperative|data not collected for all participants|||score on a scale||Standard Deviation|Mean
2550625|NCT02830087|Secondary|Range of Motion|Measure degrees of knee flexion|2-week follow-up|data not collected for all participants|||Degrees|||Number
2550626|NCT02830087|Secondary|Estimated Blood Loss|Meunier's formula will be used to calculate estimated blood loss, comparing preoperative blood draw to postoperative day 2 blood draw.|Postoperative Day 2|No data collected||||||
2550627|NCT02830087|Primary|Postoperative Pain|Pain on a 11-point pain scale (0-10), with higher scores denoting worse outcomes|Postoperative Day 1 through two weeks|data not collected for all participants|||score on a scale|||Number
2550628|NCT02829996|Other Pre-specified|Safety Parameters, Including Treatment Emergent Adverse Events, to Assess Tolerability and Safety.|Collection of safety parameters, including treatment emergent adverse events, laboratory assessments, to assess tolerability and safety.|Through Study Completion, up to 9 weeks.|||||||
2550629|NCT02829996|Primary|Mean Intraocular Pressure (IOP)|Daily change from diurnal baseline in IOP|Two Months|Intent to treat|||mm of mercury||Standard Error|Mean
2550630|NCT02829983|Secondary|Probing Depth|Distance from the bottom of sulcus/pocket to gingival margin|6 months||||milimeter||Standard Deviation|Mean
2550631|NCT02829983|Primary|Clinical Attachment Level|Distance from bottom of pocket to the cement-enamel junction (CEJ).|6 months||||milimeter||Standard Deviation|Mean
2550632|NCT02829944|Secondary|Pain Score on Movement|Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable|48 hours after surgery||||score on a scale||Inter-Quartile Range|Median
2550633|NCT02829944|Secondary|Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale|Patients contacted over the phone completed screening with the EPDS, on a scale of 0-30. A score of over 13 indicate risk for postpartum depression|6 months|Unable to make contact with 19 participants in the Placebo group and 22 participants in the Ropivacaine group.|||Participants|||Count of Participants
2550663|NCT02829320|Secondary|Dose Level of GSK1278863 at Indicated Time Points|Dose adjustment algorithm was used which was based on Hgb values at scheduled visits. Hgb values measured at unscheduled visits were not included. Mean dose during Week 12 to 24 is the average of dose at Weeks 12, 16, and 20.|Up to Week 24|All Treated Subjects Population|||mg||Full Range|Median
2550664|NCT02829320|Secondary|Change From Baseline in Total Iron Binding Capacity (TIBC)|Blood samples were collected from participants for measurement of TIBC at indicated time points. The Baseline value was the latest pre-dose assessment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline and up to Week 24|All Treated Subjects Population|||umol/L||Standard Deviation|Mean
2550665|NCT02829320|Secondary|Change From Baseline in Serum Iron|Blood samples were collected from participants for measurement of serum iron at indicated time points. The Baseline value was the latest pre-dose assessment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline and up to Week 24|All Treated Subjects Population|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2550666|NCT02829320|Secondary|Percent Change From Baseline in Hepcidin|Blood samples were collected from participants for measurement of hepcidin at indicated time points. The Baseline value was the latest pre-dose assessment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Percent change from Baseline was calculated as 100*(exponential [mean change on log scale]-1). If a laboratory value had a non-detectable level reported in the database, where the numeric value was missing, the value was not included in a summary. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to Week 24|All Treated Subjects Population|||Percentage of hepcidin||95% Confidence Interval|Geometric Mean
2550667|NCT02829320|Secondary|Percent Change From Baseline in TSAT|Blood samples were collected from participants for measurement of TSAT at indicated time points. The Baseline value was the latest pre-dose assessment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Percent change from Baseline was calculated as 100*(exponential [mean change on log scale]-1).|Baseline and up to Week 24|All Treated Subjects Population|||Percentage of transferrin||95% Confidence Interval|Geometric Mean
2550668|NCT02829320|Secondary|Change From Baseline in Ferritin|Blood samples were collected from participants for measurement of serum ferritin at indicated time points. The Baseline value was the latest pre-dose assessment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.|Baseline and up to Week 24|All Treated Subjects Population|||Microgram per liter (µg/L)||Standard Deviation|Mean
2550669|NCT02829320|Secondary|Number of Participants Who Used Iron During the Treatment Period|The number of participants who used iron (both IV and oral iron) during the treatment period were summarized.|Up to Week 24|All Treated Subjects Population|||Participants|||Count of Participants
2550670|NCT02829320|Secondary|Monthly Average Dose of Intravenous (IV) Iron During the Treatment Period|Records of on-therapy iron medication were used to calculate average quarterly IV iron dose. Quarter 1 = (Randomization Date - Treatment Start Date at Week 12 - 1 [day]). Quarter 2 = (Treatment Start Date at Week 12 - Study Treatment Stop Date). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 24|All Treated Subjects Population|||Mg||Standard Deviation|Mean
2550671|NCT02829320|Secondary|Maximum Observed Concentration (Cmax) of GSK1278863|Blood samples were collected to evaluate Cmax at 1, 2, 3 and 4 hours post dose at Weeks 12 and 24. PK parameters were calculated by standard non-compartmental analysis. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indiates data was not available. Geometric coefficient of variation could not be calculated when number of participant was equal to 1.|1, 2, 3 and 4 hours post dose at Weeks 12 and 24|PK Population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2550672|NCT02829320|Secondary|Area Under the Concentration-time Curve (AUC) From Time Zero to 4 Hours (AUC [0-4]) of GSK1278863|Blood samples were collected to evaluate AUC (0-4) at 1, 2, 3 and 4 hours post dose at Weeks 12 and 24. Pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis. PK Population consisted of all participants who received GSK1278863 with the PK samples collected and analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indiates data was not available. Geometric coefficient of variation could not be calculated when number of participant was equal to 1.|1, 2, 3 and 4 hours post dose at Weeks 12 and 24|PK Population|||Hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2550673|NCT02829320|Secondary|Number of Episodes of Achieving Hgb Level of More Than 13.0 g/dL|Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of episodes in participants who had Hgb level of more than 13.0 g/dL were summarized. On-therapy Hgb values observed in both scheduled and unscheduled visits were included.|Up to Week 24|All Treated Subjects Population|||Episodes|||Number
2550674|NCT02829320|Secondary|Number of Participants Who Had Hgb Level of More Than 13.0 g/dL|Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of participants who had Hgb level of more than 13.0 g/dL were summarized. On-therapy Hgb values observed in both scheduled and unscheduled visits were included.|Up to Week 24|All Treated Subjects Population|||Participants|||Count of Participants
2550675|NCT02829320|Secondary|Number of Participants Who Had Hgb Increase of More Than 2 g/dL Over Any 4 Weeks|Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of participants who had Hgb increase of more than 2.0 g/dL over any 4 weeks were summarized. On-therapy Hgb values observed in both scheduled and unscheduled visits were included.|Up to Week 24|All Treated Subjects Population|||Participants|||Count of Participants
2550676|NCT02829320|Secondary|Number of Participants Who Had Hgb Level of Less Than 7.5 g/dL|Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of participants who had Hgb level of less than 7.5 g/dL were summarized. On-therapy Hgb values observed in both scheduled and unscheduled visits were included.|Up to Week 24|All Treated Subjects Population|||Participants|||Count of Participants
2550677|NCT02829320|Secondary|Time to Reach the Lower Target Hgb Level (10.0 g/dL)|Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. Participants who could not reach lower target were regarded as censored. The time (in days) to reach the lower target Hgb level (10.0 g/dL) was summarized using 25th percentile (P25), median, and 75th percentile (P75) by Kaplan-Meier method.|Up to Week 24|All Treated Subjects Population|||Days||Inter-Quartile Range|Median
2550678|NCT02829320|Secondary|Number of Participants Who Had Hgb Level Within the Target Range (10.0-12.0 g/dL)|Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The number of participants with Hgb withinthe target range (10.0 to 12.0 g/dL) at each assessment visit was summarized.|Up to Week 24|All Treated Subjects Population|||Participants|||Count of Participants
2550679|NCT02829320|Secondary|Change From Baseline in Hgb at the Indicated Time Points|Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer. The Baseline value was the latest pre-dose assessment. Change from Baseline at indicated time-points was calculated by subtracting Baseline value from the post-dose visit value.|Baseline and up to Week 24|All Treated Subjects Population|||G/dL||Standard Deviation|Mean
2550680|NCT02829320|Secondary|Hgb Values at the Indicated Time Points|Blood samples were collected from participants for measurement of Hgb values at indicated time points. Hgb was evaluated using Hgb analyzer.|Up to Week 24|All Treated Subjects Population|||G/dL||Standard Deviation|Mean
2550681|NCT02829320|Primary|Number of Participants by Hgb Change From Baseline Category at Week 4|Blood samples were collected from participants for measurement of Hgb values. The Baseline value was the latest pre-dose assessment. Change from Baseline at Week 4 was calculated by subtracting Baseline value from the post-dose visit value. The change in Hgb at Week 4 was classified into different categories (i.e., <=-2.0, >-2.0 to -1.0, >-1.0 to 0, >0 to 1.0, >1.0 to 2.0, and >2 g/dL), and the number of participants in each category were summarized.|Baseline and Week 4|All Treated Subjects Population|||Participants|||Count of Participants
2550682|NCT02829320|Primary|Change From Baseline in Hgb at Week 4|Blood samples were collected from participants for measurement of Hgb values. The Baseline value was the latest pre-dose assessment. Change from Baseline at Week 4 was calculated by subtracting Baseline value from the post-dose visit value. The analysis was performed on All Treated Subjects Population which comprised of all participants who received at least one dose of GSK1278863.|Baseline and Week 4|All Treated Subjects Population|||G/dL||95% Confidence Interval|Mean
2550683|NCT02829307|Secondary|Serum Titers of Anti-GSK3128349 Antibodies|Blood samples for testing antibodies against GSK3128349 will be collected on Day 1 (pre-dose) and on Day 43. The actual date and time of each blood sample collection was recorded. The first blood sample was taken pre-dose on Day 1 to determine the presence, if any, of pre-existing ADAs. The presence of such antibodies and serum titers of anti-GSK3128349 antibodies was assessed using an ECL immuno-assay. If sera contain anti-GSK3128349 antibodies, they were further analyzed for the antibody specificity and titers.|Pre-dose on Day 1 and Day 43|Safety Population. Only those participants with positive anti-GSK3128349 antibody assay were analyzed.|||Titers||Standard Deviation|Mean
2550684|NCT02829307|Secondary|Number of Participants With Positive Anti-GSK3128349 Antibody Assay|Blood samples for testing antibodies against GSK3128349 will be collected on Day 1 (pre-dose) and on Day 43. The actual date and time of each blood sample collection was recorded. The first blood sample was taken pre-dose on Day 1 to determine the presence, if any, of pre-existing Anti Drug Antibodies (ADAs). The presence of such antibodies was assessed using an electrochemiluminescent (ECL) immuno assay. If sera contain anti-GSK3128349 antibodies, they were further analyzed for the antibody specificity and titres. Number of participants who were found to have anti-GSK3128349 antibodies are presented.|Pre-dose on Day 1 and Day 43|Safety Population.|||Participants|||Number
2550685|NCT02829307|Secondary|Number of Participants With Vital Signs of Potential Clinical Concern|Vital signs included pulse rate, systolic and diastolic blood pressure and body temperature. All vital sign measurements were made with the participant in a supine position and rested in this position for at least 5 minutes before each reading. The potential clinical concern range for systolic blood pressure: <85 and >160 millimeters of mercury (mmHg), for diastolic: <45 and >100 mmHg and heart rate: <40 and >110 beats per minute. Number of participants with vital signs of potential clinical concern are presented.|Up to 45 days|Safety Population.|||Participants|||Count of Participants
2550686|NCT02829307|Secondary|Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern|ECG measurements were made with the participant in a supine position having rested in this position for at least 5 minutes before each reading. Triplicate 12-lead ECGS were obtained pre dose at Day 1 and single 12-lead ECGs will be obtained at other time points during the study. The potential clinical concern range for ECG parameters was as follows: Absolute corrected QT (QTc) interval (lower: >450 milliseconds [msec], >450 msec, >=480 msec and >=500 msec) and (higher: <=479 msec and <=499 msec); absolute PR interval (lower: <110 and higher >220 msec) and absolute QRS interval (lower: <75 msec and >110 msec). Number of participants with ECG values of potential clinical concern are presented.|Pre-dose on Day 1, 1 h and 24 h post-dose on Day 1 and Day 45|Safety Population.|||Participants|||Number
2550687|NCT02829307|Secondary|Number of Participants With Hematology Data of Potential Clinical Concern|The potential clinical concern range for hematology parameters were: Hemoglobin (low: > 25 gram per Liter change from Baseline/Day 1 and high: > 180 gram per Liter), lymphocytes (low: < 0.8 gigacells/L), hematocrit (low: > 0.075 ratio change from Baseline and high: > 0.54 ratio), neutrophil count (low: < 1.5*10^9/Liter), platelet count (low: < 100 gigacells/L and high: > 550 gigacells/L), white blood cell (WBC) count (low: < 3 gigacells/L and high: > 20 gigacells/L). Number of participants with hematology abnormalities of potential clinical importance are presented.|Up to 45 days|Safety Population.|||Participants|||Number
2550699|NCT02829307|Secondary|Percent Area Under the Curve Obtained by Extrapolation (AUCex) and Percent Area Under the First Moment Curve Obtained by Extrapolation (AUMCex) of 89Zr-GSK3128349 and GSK3128349|PK parameters included AUCex and AUMCex. AUCex and AUMCex for 89Zr-GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by scintillation counting. AUCex and AUMCex for GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by mass spectrometry.|Pre-dose, 1 h, 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45|PK Population. Only those participants available at the specified time points were analyzed.|||Percentage area under the curve||Geometric Coefficient of Variation|Geometric Mean
2550688|NCT02829307|Secondary|Number of Participants With Clinical Chemistry Data of Potential Clinical Concern|The potential clinical concern range for clinical chemistry parameters were: glucose (low: < 3 millimole [mmol]/L and high: > 9 mmol/L), creatinine (high: Change from Baseline or Day 1 should be positive and > 44.2 mmol/L), phosphorous (low: < 0.8 mmol/L and high: > 1.6 mmol/L), magnesium (low: < 0.5 mmol/L and high: > 1.23 mmol/L), calcium (low: <2 mmoL/L and high: > 2.75 mmol/L), carbon dioxide content (low: < 18 mmol/L and high: > 32 mmol/L), albumin (low: < 30 mmol/L), potassium (low: < 3.0 mmol/L and high: > 5.5 mmol/L) and sodium (low: < 130 mmol/L and high: > 130 mmol/L). Number of participants with clinical chemistry abnormalities of potential clinical importance are presented|Up to 45 days|Safety Population.|||Participants|||Number
2550689|NCT02829307|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or is associated with liver injury or impaired liver function.|Up to 45 days|Safety Population which comprised of all participants who received a dose of 89Zr-GSK3128349.|||Participants|||Number
2550690|NCT02829307|Secondary|Mean Organ and Effective Dose|Organ dose was defined as the amount of radiation delivered to a particular organ. Effective dose was defined as the tissue-weighted sum of the organ doses in all specified tissues and organs of the human body. The organ and effective dose is a fraction of milliSievert (mSv) and MegaBecquerel (MBq). The mean relative uptake of 89Zr-GSK3128349 in different organs for all participants across all PET scans is presented.|Up to Day 7|PK Population. Only those participants available at the specified time points were analyzed.|||mSv/MBq||Standard Deviation|Mean
2550691|NCT02829307|Secondary|Clearance of 89Zr-GSK3128349 and GSK3128349|PK parameters included clearance. Clearance for 89Zr-GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by scintillation counting. Clearance for GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by mass spectrometry.|Pre-dose, 1 h, 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45|PK Population. Only those participants available at the specified time points were analyzed.|||mL/h||Geometric Coefficient of Variation|Geometric Mean
2550692|NCT02829307|Secondary|AUMC (0-inf) and AUMC (0-t) of GSK3128349|PK parameters included AUMC (0-inf) and AUMC (0-t). AUMC (0-inf) and AUMC (0-t) for GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by mass spectrometry.|Pre-dose, 1 h, 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45|PK Population. Only those participants available at the specified time points were analyzed.|||(ng/mL)*h^2||Geometric Coefficient of Variation|Geometric Mean
2550693|NCT02829307|Secondary|Area Under the First Moment Curve From Pre-dose Extrapolated to Infinite Time (AUMC [0-inf]) and Area Under the First Moment Curve From Pre-dose Extrapolated to Last Time of Quantifiable Concentration (AUMC [0-t]) of 89Zr-GSK3128349|PK parameters included AUMC (0-inf) and AUMC (0-t). AUMC (0-inf) and AUMC (0-t) for 89Zr-GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by scintillation counting.|Pre-dose, 1 h, 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45|PK Population. Only those participants available at the specified time points were analyzed.|||(Bq/mL)*h^2)||Geometric Coefficient of Variation|Geometric Mean
2550694|NCT02829307|Secondary|Volume of Distribution at a Steady State (Vss) and Volume of Distribution in the Terminal Phase (Vz) of 89Zr-GSK3128349 and GSK3128349|PK parameters included Vss and Vz. Vss and Vz for 89Zr-GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by scintillation counting. Vss and Vz for GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by mass spectrometry.|Pre-dose, 1 h, 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45|PK Population. Only those participants available at the specified time points were analyzed.|||mL||Geometric Coefficient of Variation|Geometric Mean
2550695|NCT02829307|Secondary|Elimination Rate Constant (Lambda-z) of 89Zr-GSK3128349|PK parameters included lambda-z. Cmax for 89Zr-GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by scintillation counting.|Pre-dose, 1 h, 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45|PK Population. Only those participants available at the specified time points were analyzed.|||1 per h||Geometric Coefficient of Variation|Geometric Mean
2550696|NCT02829307|Secondary|Apparent Terminal Phase Half-life (t1/2) and Mean Residence Time (MRT) of 89Zr-GSK3128349 and GSK3128349|PK parameters included t1/2 and MRT. t1/2 and MRT for 89Zr-GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by scintillation counting. t1/2 and MRT for GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by mass spectrometry.|Pre-dose, 1 h, 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45|PK Population. Only those participants available at the specified time points were analyzed.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2550697|NCT02829307|Secondary|Cmax of GSK3128349|PK parameters included Cmax. Cmax for GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by mass spectrometry.|Pre-dose, 1 h, 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45|PK Population. Only those participants available at the specified time points were analyzed.|||Nanogram (ng) per mL||Geometric Coefficient of Variation|Geometric Mean
2550698|NCT02829307|Secondary|Maximum Observed Plasma Concentration (Cmax) of 89Zr-GSK3128349|PK parameters included Cmax. Cmax for 89Zr-GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by scintillation counting.|Pre-dose, 1 h, 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45|PK Population. Only those participants available at the specified time points were analyzed.|||Bq per mL||Geometric Coefficient of Variation|Geometric Mean
2551042|NCT02822612|Secondary|Number of Participants That Presented Gradable Data, by Examination Type|To identify potential user errors, particularly those with a likelihood of generating erroneous examination findings (e.g., failure to comply with device instructions or errors in voice recognition).|4 months||||Participants|||Count of Participants
2550700|NCT02829307|Secondary|Area Under Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) and Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC [0-inf]) of 89Zr-GSK3128349 and GSK3128349|PK parameters included AUC (0-t) and AUC (0-inf). AUC (0-t) and AUC (0-inf) for 89Zr-GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by scintillation counting. AUC (0-t) and AUC (0-inf) for GSK3128349 was calculated from the whole blood and plasma concentration-time data, measured by mass spectrometry.|Pre-dose, 1 hour (h), 3 h, 6 h, 8h, 24 h post-dose, Day 4, Day 6, Day 14, Day 22, Day 33 and Day 45|PK Population. Only those participants available at the specified time points were analyzed.|||(Becquerel [Bq] per mL)*h||Geometric Coefficient of Variation|Geometric Mean
2550701|NCT02829307|Primary|Mean Volume of ROI for Each Organ at All Time Points|Volume of ROI is the volume specified in organs as measured in PET or CT images. Mean volume of ROI for each organ has been presented.|Up to Day 7|PK Population. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|||Milliliter (mL)||Standard Deviation|Mean
2550702|NCT02829307|Primary|Mean Standardized Uptake Values (SUVs) Derived From Positron Emission Tomography-Computer Tomography (PET-CT) Data|SUV is a mathematically derived ratio of tissue radioactivity concentration and the injected dose of radioactivity per kilogram of the participant's body weight at a given point in time. SUV was analyzed for each region of interest (ROI) such as liver, kidney, muscle, spleen, heart, lung, bladder, thymus, and if feasible blood and bone. A maximum of 4 PET scans were conducted in each participant. Mean SUV derived from PET-CT has been presented.|Up to Day 7|Pharmacokinetic (PK) Population comprised of participants in the Safety Population for whom a PK sample was obtained and analyzed, and/or for which a PET scan was completed. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|||Ratio||Standard Deviation|Mean
2550703|NCT02829294|Secondary|Improvements in Ear Specific Clinical Symptoms After 1 or 2, 15 Minute Applications of E002|Collect symptom information prior to and post treatment with the novel test solution designed to help clean and clear the ear canal of debris including cerumen|Immediately following 1 or 2 treatments|There were 19 participants and of these 19 participants there were 30 ears that met the inclusion criteria.|||% of participants reporting change|||Number
2550704|NCT02829294|Primary|Safety Measured by the Collection of Unsolicited Adverse Events Reported by Patients|Ear canal specific safety evaluation, measured by physician, during the course of treatment up to 48 hours post treatment and collection of adverse events (related and non-related)|After treatment|64.8 years +/- 12.3|||number of ears with reported pruritus|ears||Number
2550705|NCT02829294|Primary|Percentage of Ears That Showed Change in Visualization of the Tympanic Membrane (Ear Drum) Following 15 or 30 Minutes of Using the Test Product|Cerumen impaction will be graded following 15 and 30 minutes after using the test product in the external ear canal. Cerumen impaction is graded by the % of the ear drum is visible using an otoscope. Grade 5 (severe) = 76-100% of the ear drum is obstructed from view. Grade 4 (moderate) = 51-75% of the ear drum is obstructed from view. Grade 3 (mild) = 26-50% of the ear drum is obstructed from view. Grade 2 = 3-25% of the ear drum is obstructed from view. Grade 1 (normal) = less than 3% of the ear drum is obstructed from view.|15 and 30 minutes|Individual ears that met all inclusion/exclusion criteria|||percentage of ears|ears||Number
2550706|NCT02829138|Secondary|Change in Omega-3 Index in Blood (Physiological Parameter)|Blood fatty acids measured by gas chromatography. Data is reported as a percentage of all detected fatty acids. The omega-3 index is calculated by summing data for 3 omega-3 fats in serum: ALA, EPA, and DHA.|baseline and 12 weeks||||percentage of total fatty acids in serum||Standard Error|Mean
2550707|NCT02829138|Secondary|Change in Blood Triglycerides (Physiological Parameter)|Triglycerides were measured in fasted serum. Data is reported as mmol/L|baseline and 12 weeks||||mmol/L||Standard Error|Mean
2550708|NCT02829138|Primary|Omega-3 Dietary Intake|Omega-3 fat intake was assessed using food frequency questionnaires. The Canadian Nutrient File (version 2015) was used to assess the amount of EPA and DHA in whole foods (e.g., fish, eggs, poultry). Data corresponds to EPA + DHA (mg /day).|Baseline and 12 weeks||||mg/day||Standard Error|Mean
2550709|NCT02829034|Secondary|Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)|NT-proBNP measured at 6-months compared to baseline|6 months|completers|||pg/mL||Standard Error|Least Squares Mean
2550710|NCT02829034|Secondary|Percent Change in 6min-walk-test Distance|6-minute walk test|6 months|complete and recorded data|||percentage of distance walked||Standard Error|Least Squares Mean
2550711|NCT02829034|Primary|Absolute Change From Baseline Right Ventricular Ejection Fraction (the Unit is Percentage)|Change in right ventricle ejection fraction as assessed by MRI|26 weeks|participants who completed follow up study at 6 months.|||percentage||Standard Error|Least Squares Mean
2550712|NCT02828644|Secondary|Sustained Effects in Attention From End-of-treatment (Follow-Up Day 0) to Follow-Up Day 28 Across Groups That Were Previously Randomized to Receive 4 Weeks of Digital Therapy|"TOVA API is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. The API is calculated from variability, response time, and d' (D Prime) using the following formula:~API = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80~where Response Time is the average time it takes to respond correctly to a target, d' score is a response discriminability score reflecting the ratio of hits to false alarms, and Variability is a measure of consistency of speed of responding based on the standard deviation of the mean correct response times. API tells how similar the score is to the ADHD profile. A score of less than 0 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile.~The calculation for difference in TOVA API was API at Day 28 minus API at Day 0 of this study."|Day 0 to Day 28|All subjects who were enrolled in 001R/NCT02674633, completed 4 weeks of at-home play, and completed the Day 0 and Day 28 visits of this study.|||z-score||Standard Deviation|Mean
2550727|NCT02828124|Secondary|Total Body Clearance (CLT)|to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by CLT|First dose to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550713|NCT02828644|Primary|Sustained Effects in Attention From End-of-treatment (Follow-Up Day 0) to Follow-Up Day 28 Within Groups That Were Previously Randomized to Receive 4 Weeks of Digital Therapy|"TOVA API is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. The API is calculated from variability, response time, and d' (D Prime) using the following formula:~API = Response Time Z score (Half 1) + d' Z score (Half 2) + Variability Z score (Total) + 1.80~where Response Time is the average time it takes to respond correctly to a target, d' score is a response discriminability score reflecting the ratio of hits to false alarms, and Variability is a measure of consistency of speed of responding based on the standard deviation of the mean correct response times. API tells how similar the score is to the ADHD profile. A score of less than 0 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile.~The calculation for difference in TOVA API was API at Day 28 minus API at Day 0 of this study."|Day 0 to Day 28|All subjects who were randomized to the AKL-T01 arm in 001R/NCT02674633, completed 4 weeks of at-home play, and completed the Day 0 and Day 28 visits of this study.|||z-score||Standard Deviation|Mean
2550714|NCT02828241|Primary|Number of Subjects With Treatment Success by Clinician's Erythema Assessment (CEA) Scale|Number of subjects with Treatment Success defined as a score of 0 or 1 and a 2 grade improvement on the CEA scale from Baseline to 12 weeks.|At end of study (12 weeks)|ITT population|||participants|||Number
2550715|NCT02828241|Primary|Number of Subjects With Investigator's Global Assessment (IGA) Success|Number of subjects with treatment success based on Investigator's Global Assessment (IGA) score at the End of Treatment, defined as an IGA score of 0 (clear) or 1 (almost clear) with composite grade change from Baseline of at least 2 points.|At the end of study (12 weeks)|Intent to Treat (ITT) population|||participants|||Number
2550716|NCT02828241|Primary|Change in Inflammatory Lesion Counts|Mean change from Baseline in the inflammatory lesion count at the End of Treatment. A lower score at the end of the study compared to Baseline is considered a better outcome.|At the end of study (12 weeks)|Intent to Treat (ITT)|||Number of lesions||Standard Deviation|Mean
2550717|NCT02828137|Primary|Index of Microcirculatory Resistance|IMR in low NLR group : 21.94 ± 12.87 IMR in intermediate NLR group : 23.22 ± 12.73 IMR in high NLR group : 32.95 ± 20.60|3 months||||IMR||Standard Deviation|Mean
2550718|NCT02828124|Secondary|Incidence of Positive Anti-drug Antibody (ADA)|The immunogenicity of BMS-986183 (as monotherapy and in combination with nivolumab) will be measured by assessment of the presence or absence of specific ADA to BMS-986183. The incidence of positive ADA will be calculated.|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550719|NCT02828124|Secondary|Changes in QTcF (ΔQTcF) From Baseline|To assess the effect of dosage regimen and exposure [active ADC and unconjugated tubulysin] of BMS-986183 as monotherapy on the QT interval.|Baseline up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550720|NCT02828124|Secondary|Terminal Half-life (T-HALF)|to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by T-HALF.|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550721|NCT02828124|Secondary|Average Concentration Over a Dosing Interval Calculated by Dividing AUC(TAU) at Steady State by Tau (Css,Ave)|To characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Css,avg.|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550722|NCT02828124|Secondary|Accumulation Index; Ratio of AUC(TAU) at Steady-state to AUC(TAU) After the First Dose [AI_AUC(TAU)]|To characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AI_AUC(TAU).|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550723|NCT02828124|Secondary|Accumulation Index; Ratio of Ctau at Steady-state to Ctau After the First Dose (AI_Ctau)|to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AI_Ctau.|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550724|NCT02828124|Secondary|Accumulation Index; Ratio of Cmax at Steady-state to Cmax After the First Dose (AI_Cmax)|to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AI_Cmax.|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550725|NCT02828124|Secondary|Volume of Distribution of Terminal Phase (Vz)|(to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Vz.|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550726|NCT02828124|Secondary|Apparent Volume of Distribution at Steady-state (Vss)|to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Vss|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2552314|NCT02796300|Primary|Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.|A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups|1 month||||catheter thrombosis per month||Standard Error|Mean
2550728|NCT02828124|Secondary|Trough Observed Concentration, Including Predose Concentrations and Ctau (Ctrough)|to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by (Ctrough)|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550729|NCT02828124|Secondary|Concentration at the End of a Dosing Interval (Ctau)|To characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550730|NCT02828124|Secondary|Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)]|To characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AUC(TAU).|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550731|NCT02828124|Secondary|Area Under the Concentration-time Curve From Time 0 to T of the Last Quantifiable Concentration [AUC(0-T)]|to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AUC(0-T)]|First does up to appromimately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550732|NCT02828124|Secondary|Time of Maximum Observed Concentration (Tmax)|to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Tmax.|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550733|NCT02828124|Secondary|Maximum Observed Concentration (Cmax)|To characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Cmax|From first does up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550734|NCT02828124|Secondary|PFS Rate at Week 't'|Defined as the proportion of subjects who remain progression free and surviving at 't' weeks (t=12, 24, 36, etc). The proportion will be calculated by the product-limit method (Kaplan-Meier [K-M] estimate) which takes into account censored data|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550735|NCT02828124|Secondary|Progression Free Survival (PFS)|Defined as the time from the first dose of study drug to the date of the first objective documentation of tumor progression or death due to any cause. Subjects who did not progress nor died will be censored on the date of their last tumor assessment. Subjects who did not have any on-study tumor assessments will be censored on the date of the first dose of study drug.|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550736|NCT02828124|Secondary|Duration of Response (DoR)|Defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first. For those subjects who remain alive and have not progressed or received subsequent therapy, DoR will be censored on the date of last tumor assessment|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550737|NCT02828124|Secondary|Overall Response Rate (ORR)|Defined as the total number of subjects whose BOR is either a CR or PR divided by the total number of subjects in the population of interest|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550738|NCT02828124|Secondary|Best Overall Response (BOR)|Defined as BOR designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. CR or PR determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met.|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550739|NCT02828124|Primary|Incidence of Laboratory Test Toxicity Grade Shifting From Baseline||First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550740|NCT02828124|Primary|Incidence of Adverse Events Leading to Death|Evaluated by comparing the incidence of Adverse Events leading to death among subjects using their assigned treatment for at least one day.|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550741|NCT02828124|Primary|Incidence of Adverse Events Leading to Discontinuation|Evaluated by comparing the incidence of Adverse Events leading to discontinuation among subjects using their assigned treatment for at least one day.|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550742|NCT02828124|Primary|Incidence of Serious Adverse Events at Its Worst Grade|Evaluated by comparing the incidence of Serious Adverse Events (SAEs) among subjects using their assigned treatment for at least one day.|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550743|NCT02828124|Primary|Incidence of Adverse Events at Its Worst Grade|Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day.|First dose up to approximately 24 months|The study was terminated and data is not reported for privacy reasons.||||||
2550799|NCT02827500|Secondary|Changes in Symptoms and Quality of Life as Measured by Patient Global Assessment (PGA)|Change from baseline is calculated as 180 day - baseline results. Scores range 0-100, where a higher score indicates a worse outcome.|baseline, 180 days|Participants who completed the PGA at both timepoints.|||score on a scale||Standard Deviation|Mean
2550744|NCT02828111|Post-Hoc|Percentage of Treatment-targeted SEBs Achieving Clear on the ISGTA Scale and BCC Not Present at Week 12|The ISGTA is a scale with scores ranging from 0 (clear), 1 (almost clear), 2 (minimal residual tumor), to 3 (clearly visible tumor). The Investigator assessed each Baseline treatment-targeted SEB at Week 12. SEBs were defined as clinically diagnosed BCC 5 to 20 mm in diameter on the face, excluding the nose and periorbital skin, and 9 to 20 mm at sites other than the face. The percentage of Baseline treatment-targeted SEBs evaluated as being clear at Week 12 based on the ISGTA scale and BCC not present was calculated as follows: (Number of baseline treatment-targeted SEBs with ISGTA score of 0 and BCC not present at Week 12) / (Number of Baseline treatment-targeted SEBs) * 100.|Week 12|Participants who received at least 1 dose of study drug.|||percentage of SEBs|||Number
2550745|NCT02828111|Other Pre-specified|Percent Change in Treatment-targeted SEBs Tumor Size From Baseline as Determined by Blinded Photographic Review|SEBs were defined as clinically diagnosed BCC 5 to 20 mm in diameter on the face, excluding the nose and periorbital skin, and 9 to 20 mm at sites other than the face. The percent change in greatest diameters of Baseline treatment-targeted SEBs from Baseline to Week 12 was calculated as follows: (sum [Baseline] - sum [Week 12] / sum [Baseline]) * 100), where sum = the greatest diameters of treatment-targeted SEBs.|Baseline, Week 12|Participants who received at least 1 dose of study drug.|||percentage change from Baseline||Standard Deviation|Mean
2550746|NCT02828111|Other Pre-specified|Percentage of Treatment-targeted SEBs Achieving Clear or Almost Clear on the Investigator Static Global Tumor Assessment (ISGTA) Scale|The ISGTA is a scale with scores ranging from 0 (clear), 1 (almost clear), 2 (minimal residual tumor), to 3 (clearly visible tumor). The Investigator assessed each Baseline treatment-targeted SEB at Weeks 2, 6, 8, 10, and 12. SEBs were defined as clinically diagnosed BCC 5 to 20 mm in diameter on the face, excluding the nose and periorbital skin, and 9 to 20 mm at sites other than the face. The percentage of Baseline treatment-targeted SEBs evaluated as being clear or almost clear at Week x (Week x = 2, 6, 8, 10, or 12) based on the ISGTA scale was calculated as follows: (Number of baseline treatment-targeted SEBs with ISGTA score of 0 or 1 at Week x) / (Number of Baseline treatment-targeted SEBs) * 100. Missing data were imputed using LOCF. The percentage of responders achieving clear (0) or almost clear (1) on the ISGTA scale are presented by Week.|Baseline and Weeks 2, 6, 8, 10, and 12|Participants who received at least 1 dose of study drug.|||percentage of SEBs|||Number
2550747|NCT02828111|Secondary|Clinical Efficacy: Percentage of SEBs Showing Complete or Partial Response at Week 12 as Determined by Blinded Photographic Review|SEBs were defined as clinically diagnosed BCC 5 to 20 mm in diameter on the face, excluding the nose and periorbital skin, and 9 to 20 mm at sites other than the face. The percentage of tumors showing a complete or partial response at Week 12 was calculated as follows: (Number of baseline treatment-targeted SEBs showing complete or partial response at Week 12) / (Number of Baseline treatment-targeted SEBs) * 100. Missing values were not imputed.Complete Response is determined when there is no longer any visible evidence of a lesion consistent with BCC at the site, and Partial Response is determined when although a BCC still remains at this site, it has demonstrated a visible decrease in size compared with baseline.|Baseline, Week 12|Participants who received at least 1 dose of study drug.|||percentage of SEBs|||Number
2550748|NCT02828111|Secondary|Clinical Efficacy: Percent Change From Baseline in Tumor Size of Treatment-targeted SEBs at Week 12|SEBs were defined as clinically diagnosed BCC 5 to 20 mm in diameter on the face, excluding the nose and periorbital skin, and 9 to 20 mm at sites other than the face. The percent change in greatest diameters of treatment-targeted surgically eligible basal cell carcinomas (SEBs) from Baseline to Week 12 was calculated as follows: (sum [Baseline] - sum [Week 12] / sum [Baseline] * 100), where sum = the greatest diameters of treatment-targeted SEBs and positive numbers to represent increases and negative numbers to represent decreases. Missing values were imputed using Last-Observation Carried Forward (LOCF).|Baseline, Week 12|Participants who received at least 1 dose of study drug.|||percent change in tumor size||Standard Deviation|Mean
2550749|NCT02828111|Primary|Molecular Efficacy: Percent Change From Baseline in the Hedgehog (HH) Signaling Pathway Target Gene Glioma-associated Oncogene Homolog 1 (GLI1) Messenger Ribonucleic Acid (mRNA) Levels at Week 12|GLI1 change is a biomarker of the HH signaling pathway. A change in GLI1 mRNA levels reflect a change in the HH pathway. Surgically eligible basal cell carcinomas (SEBs) were defined as clinically diagnosed basal cell carcinoma (BCC) 5 to 20 millimeters (mm) in diameter on the face, excluding the nose and periorbital skin, and 9 to 20 mm at sites other than the face. A single baseline BCC designated as a treatment-targeted tumor at Baseline was biopsied first at Baseline and again following 12 weeks of treatment. This was used to assess percent change in GLI1 mRNA levels as follows: (Baseline - Week 12) / Baseline * 100, with positive numbers to represent increases and negative numbers to represent decreases. Any missing values were not imputed; all available data is summarized.|Baseline, Week 12|Participants who received at least 1 dose of study drug who had evaluable GLI1 mRNA data at Baseline and Week 12.|||percent change in GLI1 mRNA levels||Standard Deviation|Mean
2550750|NCT02828111|Primary|Number of Treatment-emergent Adverse Events (Including Both Serious and Non-Serious) Causally Related to Study Drug|All serious adverse events (SAEs) and all other non-serious adverse events (AEs) regardless of causality are located in the Reported AE Module. The number of AEs (including both serious and non-serious) considered related to study drug by the Investigator are presented below. Treatment-emergent AEs are those with an onset after use of study drug.|Baseline through Week 12|All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.|||number of events|||Number
2550751|NCT02828020|Secondary|Percentage of Participants With Absence of Nausea at 2 Hours After the Initial Dose|Nausea was a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of nausea. Number analyzed is the number of participants with non-missing postdose nausea assessment at or before 2 hours after initial dose.|2 hours after initial dose|mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.|||percentage of participants|||Number
2550800|NCT02827500|Secondary|Changes in Symptoms and Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score|Change from baseline is calculated as 180 day - baseline results. Scores range 0-100, where a higher score indicates a better outcome.|baseline, 180 days|Participants who completed the KCCQ at both timepoints.|||score on a scale||Standard Deviation|Mean
2550752|NCT02828020|Secondary|Percentage of Participants With the Absence of Phonophobia at 2 Hours After the Initial Dose|Phonophobia was defined as sensitivity to sound, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence of phonophobia. Number analyzed is the number of participants with non-missing postdose phonophobia assessment at or before 2 hours after initial dose.|2 hours after initial dose|mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.|||percentage of participants|||Number
2550753|NCT02828020|Secondary|Percentage of Participants With the Absence of Photophobia at 2 Hours After the Initial Dose|Photophobia was defined as sensitivity to light, a migraine-associated symptom. Participants were provided with an eDiary to record absence or presence photophobia. Number analyzed is the number of participants with non-missing postdose photophobia assessment at or before 2 hours after initial dose.|2 hours after initial dose|mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.|||percentage of participants|||Number
2550754|NCT02828020|Secondary|Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours After Initial Dose|Sustained pain freedom was defined as a pain freedom at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a mild/moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with determinable sustained pain freedom from 2 to 24 hours after initial dose.|2 to 24 hours after initial dose|mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, determinable cases.|||percentage of participants|||Number
2550755|NCT02828020|Secondary|Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours After Initial Dose|Sustained pain relief was defined as a pain relief at 2 hours with no administration of either rescue medication or the second dose of study drug, and with no occurrence thereafter of a moderate/severe headache up to 24 hours after dosing with study drug. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Determinable cases: participants for whom sustained pain relief from 2 to 24 hours status can be determined based on the observed headache severity at scheduled time points, use of rescue medication or optional second dose between 2 and 24 hours, and the answer to the headache recurrence question at 24 hours. Number analyzed is the number of participants with determinable sustained pain relief from 2 to 24 hours after initial dose.|2 to 24 hours after initial dose|mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, determinable cases.|||percentage of participants|||Number
2550756|NCT02828020|Secondary|Percentage of Participants With Pain Relief at 2 Hours After the Initial Dose|Pain relief was defined as a reduction of a moderate/severe migraine headache to a mild headache or to no headache. Participants were provided with an eDiary to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing pain severity assessment at or before 2 hours after initial dose.|Baseline (Predose) to 2 hours after initial dose|mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.|||percentage of participants|||Number
2550757|NCT02828020|Primary|Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose|The most bothersome migraine-associated symptom was the symptom (photophobia, phonophobia or nausea) present at pre-dose baseline identified by the participant to be 'most bothersome'. Participants were provided with an eDiary to record absence or presence of migraine-associated symptoms. Number analyzed is the number of participants with non-missing postdose most bothersome migraine-associated symptoms.|Baseline (Predose) to 2 hours after initial dose|mITT population included all randomized participants who received at least 1 dose of investigational product, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, LOCF.|||percentage of participants|||Number
2550758|NCT02828020|Primary|Percentage of Participants With Pain Freedom at 2 Hours After Initial Dose|Pain freedom was defined as a reduction in headache severity from moderate/severe at baseline to no pain at 2 hours after the initial dose. Participants were provided with an electronic diary (eDiary) to rate headache severity on a scale from no pain to severe pain. Number analyzed is the number of participants with non-missing postdose pain severity assessment at or before 2 hours after initial dose.|Baseline (Predose) to 2 hours after initial dose|Modified Intent-to-Treat (mITT) population included all randomized participants who received at least 1 dose of study drug, recorded a baseline migraine headache severity measurement, and had ≥ 1 postdose migraine headache severity or migraine-associated symptom measurement at or before the 2-hour timepoint, last observation carried forward (LOCF).|||percentage of participants|||Number
2550759|NCT02827708|Secondary|Change in Urinalysis|"Participants with urinalysis, leukocytes and erythrocytes findings, negative, trace, small, moderate or large at baseline (week [wk] 0) and wk 26 are presented. Participants with urinalysis, nitrit findings, negative or positive at baseline (wk 0) and wk 26 are presented. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication."|Week -2, week 26|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2550760|NCT02827708|Secondary|Change in DTSQs: Individual Items and Treatment Satisfaction Score (6 of the 8 Items Summed)|"Change from baseline (week 0) in Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) was evaluated at week 26. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of hyperglycaemia and hypoglycaemia, respectively. Thus, lower scores indicate a perception of blood glucose levels being none of the time unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score has a minimum of 0 and a maximum of 36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction."|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Score||Standard Deviation|Mean
2550761|NCT02827708|Secondary|Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)|SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at week 26. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.|Week 0, week 26|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Score||Standard Deviation|Mean
2550762|NCT02827708|Secondary|SNAC Plasma Concentrations|This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Sodium N-[8-(2-hydroxybenzoyl) amino]caprylate (SNAC) plasma concentrations were measured after 25 and 40 minutes post-dose at weeks 4, 14 and 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Weeks 0-26|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2550763|NCT02827708|Secondary|Semaglutide Plasma Concentrations for Population PK Analyses|This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Semaglutide plasma concentrations were measured at weeks 4, 8, 14 and 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Weeks 0-26|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Nanomoles per litre (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2550764|NCT02827708|Secondary|Anti-semaglutide Binding Antibody Levels|This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-31). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-31|Overall number of participants analysed = participants who were found positive for anti-semaglutide antibodies. As only one subject was analyzed, standard deviation could not be calculated.|||%B/T||Standard Deviation|Mean
2550765|NCT02827708|Secondary|Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)|This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (weeks 0-31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-31|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2550766|NCT02827708|Secondary|Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)|This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (weeks 0-31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-31|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2550767|NCT02827708|Secondary|Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)|This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (weeks 0-31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-31|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2550801|NCT02827500|Secondary|Number of Patients With Heart Rate <70 Bpm at 180 Days||180 days||||Participants|||Count of Participants
2550802|NCT02827500|Secondary|Heart Rate at 180 Days|Heart rate results are obtained from vital sign assessment when available otherwise results from ECG assessment are used from day 180.|180 days||||beats per minute||Standard Deviation|Mean
2550768|NCT02827708|Secondary|Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)|This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (weeks 0-31) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-31|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2550769|NCT02827708|Secondary|Change in Eye Examination|Participants with eye examination findings, normal, abnormal NCS and abnormal CS at baseline (week -2) and week 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week -2, week 26|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2550770|NCT02827708|Secondary|Change in Physical Examination|Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (week [wk] -2) and wk 26 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Nervous system (central and peripheral); 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head (ears, eyes, nose), throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.|Week -2, week 26|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2550771|NCT02827708|Secondary|Change in ECG|Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at week 26. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2550772|NCT02827708|Secondary|Change in Urinary Albumin to Creatinine Ratio (Ratio to Baseline)|Change from baseline (week 0) in urinary albumin to creatinine ratio (mg/mmol) at week 26 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2550773|NCT02827708|Secondary|Change in Blood Pressure (Systolic and Diastolic Blood Pressure)|Change from baseline (week 0) in systolic and diastolic blood pressure was evaluated at week 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||mmHg||Standard Deviation|Mean
2550774|NCT02827708|Secondary|Change in Pulse Rate|Change from baseline (week 0) in pulse rate was evaluated at week 26. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Beats/minute||Standard Deviation|Mean
2550775|NCT02827708|Secondary|Change in Lipase (Ratio to Baseline)|Change from baseline (week 0) in lipase (U/L) at week 26 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio of lipase||Geometric Coefficient of Variation|Geometric Mean
2550776|NCT02827708|Secondary|Change in Amylase (Ratio to Baseline)|Change from baseline (week 0) in amylase (units/litre (U/L)) at week 26 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio of amylase||Geometric Coefficient of Variation|Geometric Mean
2550777|NCT02827708|Secondary|Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no)|Number of participants with treatment emergent severe or BG-confirmed symptomatic hypoglycaemic episodes was recorded from week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Hypoglycaemic episodes with onset during the first dose of trial product until last dose of trial product were considered treatment -emergent. Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode, that is severe according to the ADA classification or BG-confirmed by a plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Weeks 0-31|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Participants|||Count of Participants
2550803|NCT02827500|Secondary|Change in Heart Rate|Change from baseline is calculated as 180 days - baseline results. Heart rate results are obtained from vital sign assessment when available otherwise results from ECG assessment are used.|baseline,180 days||||beats per minute||Standard Deviation|Mean
2550804|NCT02827500|Primary|Number of Participants Taking Ivabradine at 180 Days||180 days|Intent to treat population|||Participants|||Count of Participants
2550778|NCT02827708|Secondary|Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes|Treatment emergent severe or BG-confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Hypoglycaemic episodes with onset during the first dose of trial product until last dose of trial product were considered treatment -emergent. Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode, that is severe according to the ADA classification or BG-confirmed by a plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Weeks 0-31|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Episodes|||Number
2550779|NCT02827708|Secondary|Number of TEAEs|Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 31 (26 weeks treatment period + 5 weeks follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Weeks 0-31|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.|||Events|||Number
2550780|NCT02827708|Secondary|Time to Rescue Medication|Presented results are the number of participants who had taken rescue medication anytime during the period, from week 0 to week 26. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Weeks 0-26|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2550781|NCT02827708|Secondary|Time to Additional Anti-diabetic Medication|Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the period, from week 0 to week 26. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 26), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-26|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2550782|NCT02827708|Secondary|Change in CRP (Ratio to Baseline)|Change from baseline (week 0) in C-reactive protein (CRP) (mg/L) at week 26 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio of CRP||Geometric Coefficient of Variation|Geometric Mean
2550783|NCT02827708|Secondary|Change in Triglycerides (Ratio to Baseline)|Change from baseline (week 0) in triglycerides (mmol/L) at week 26 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio of triglycerides||Geometric Coefficient of Variation|Geometric Mean
2550784|NCT02827708|Secondary|Change in HDL Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol (mmol/L) at week 26 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio of HDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2550785|NCT02827708|Secondary|Change in LDL Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at week 26 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio of LDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2550786|NCT02827708|Secondary|Change in Total Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in total cholesterol (mmol/L) at week 26 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Ratio of total cholesterol||Geometric Coefficient of Variation|Geometric Mean
2550787|NCT02827708|Secondary|Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)|Participants who achieved HbA1c reduction ≥1% and weight loss of ≥3% (yes/no) was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2550788|NCT02827708|Secondary|Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)|Participants who achieved HbA1c <7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) was evaluated at week 26. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2550789|NCT02827708|Secondary|Participants Who Achieve Weight Loss ≥10% (Yes/no)|Participants who achieved weight loss of ≥10% of their baseline body weight (yes/no) was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2550790|NCT02827708|Secondary|Participants Who Achieve Weight Loss ≥5% (Yes/no)|Participants who achieved weight loss ≥5% of their baseline body weight (yes/no) was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2550791|NCT02827708|Secondary|Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol), AACE Target (Yes/no)|Participants who achieved HbA1c ≤6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no), was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2550792|NCT02827708|Secondary|Participants Who Achieve HbA1c <7.0% (53 mmol/Mol), ADA Target (Yes/no)|Participants who achieved HbA1c <7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2550793|NCT02827708|Secondary|Change in Waist Circumference|Change from baseline (week 0) in waist circumference was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Centimetre (cm)||Standard Deviation|Mean
2550794|NCT02827708|Secondary|Change in BMI|Change from baseline (week 0) in body mass index (BMI) was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||kg/m^2||Standard Deviation|Mean
2550795|NCT02827708|Secondary|Change in Body Weight (%)|Relative change from baseline (week 0) in body weight (kg) was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Percentage change||Standard Deviation|Mean
2550796|NCT02827708|Secondary|Change in FPG|Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 26. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2550797|NCT02827708|Secondary|Change in Body Weight (kg)|Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Week 0, week 26|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||kg||Standard Deviation|Mean
2550798|NCT02827708|Primary|Change in HbA1c|Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Week 0, week 26|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2550805|NCT02826798|Secondary|Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells||Through Day 336 or early withdrawal|Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. The group means and standard deviations of positive samples are shown, except where no samples tested positive (neither mean nor standard deviation could be calculated) or only one sample tested positive (standard deviation could not be calculated).|||Titer||Standard Deviation|Geometric Mean
2550806|NCT02826798|Secondary|Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells||Through Day 196 or early withdrawal|Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. Samples with antibody titers below the assay cut point were not included in the calculation of geometric mean or standard deviation.|||Titer||Standard Deviation|Geometric Mean
2550807|NCT02826798|Secondary|Geometric Mean Titer of Antibody Avidity Index Value Against gB|To measure the avidity of responses against CMV gB protein, a standard ELISA assay using recombinant gB protein which did or did not include treatment with 5M urea for 30 minutes of samples after sera had been incubated with recombinant protein. The reported value, or Avidity Index, represents the percent of signal measured in ELISA after treatment with urea relative to samples not exposed to urea.|Through Day 336 or early withdrawal|Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects.|||Avidity index||Standard Deviation|Geometric Mean
2550808|NCT02826798|Secondary|Geometric Mean Titer of Antibody Binding to CMV gB||Through Day 336 or early withdrawal|Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects. The group means and standard deviations of positive samples are shown, except where no samples tested positive (neither mean nor standard deviation could be calculated) or only one sample tested positive (standard deviation could not be calculated).|||Titer||Standard Deviation|Geometric Mean
2550809|NCT02826798|Primary|Number of Participants With Any Hematological or Biochemical Laboratory Abnormality|Blood and urine samples were collected at screening for all evaluations with additional blood samples obtained on Days 28, 56, 84, 168, 196, 280, and 336. The following clinical laboratory evaluations were performed: Biochemistry: alanine aminotransferase; aspartate aminotransferase; creatinine; blood urea nitrogen; Hematology: neutrophils, lymphocytes, eosinophils, hemoglobin, platelet count, white blood cell count; Infection status: HIV, hepatitis B, hepatitis C, and cytomegalovirus; and Urinalysis: blood, glucose, protein.|Through Day 336 or early withdrawal|Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects.|||Participants|||Count of Participants
2550810|NCT02826798|Primary|Number of Participants With Any Serious Adverse Event||Through Day 336 or early withdrawal|Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects.|||Participants|||Count of Participants
2550811|NCT02826798|Primary|Number of Participants With Any Adverse Event||Following each of the 3 injections of study vaccine, the occurrence of adverse events was captured during a 28-day follow-up period as well as through Day 336 or early withdrawal.|Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects.|||Participants|||Count of Participants
2550812|NCT02826798|Primary|Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period||Day of vaccine administration (days 0, 56, 168) and six subsequent days|Analyses were performed on the total vaccinated cohort (TVC), which includes all immunized subjects.|||Participants|||Count of Participants
2550813|NCT02826603|Secondary|Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 52|Number of participants who achieved ≥ 90% reduction in PASI at Week 52 compared to baseline.|Week 52|FAS|||Participants|||Count of Participants
2550814|NCT02826603|Secondary|Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 16|Number of participants who achieved ≥ 90% reduction in PASI at Week 16 compared to baseline.|Week 16|FAS|||Participants|||Count of Participants
2550815|NCT02826603|Secondary|Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16|Number of participants who achieved ≥ 75% reduction in PASI at Week 16 compared to baseline.|Week 16|FAS|||Participants|||Count of Participants
2550816|NCT02826603|Secondary|Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 12|Number of participants who achieved 100% reduction in PASI at Week 12 compared to baseline.|Week 12|FAS|||Participants|||Count of Participants
2550817|NCT02826603|Secondary|Participants With IGA Mod 2011 0 or 1 at 16 Weeks|Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)|Week 16|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.|||Participants|||Count of Participants
2550818|NCT02826603|Secondary|Participants Who Achieved Psoriasis Area and Severity Index (PASI) 100 Response at Week 16|Number of participants who achieved 100% reduction in PASI at Week 16 compared to baseline.|Week 16|FAS|||Participants|||Count of Participants
2550819|NCT02826603|Secondary|Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 4|Number of participants who achieved ≥ 75% reduction in PASI at Week 4 compared to baseline.|Week 4|FAS|||Participants|||Count of Participants
2550820|NCT02826603|Secondary|Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 12|Number of participants who achieved ≥ 75% reduction in PASI at Week 12 compared to baseline.|Week 12|FAS|||Participants|||Count of Participants
2550821|NCT02826603|Primary|Participants With IGA Mod 2011 0 or 1 at Week 12|Investigator's Global Assessment uses a scale (IGA mod 2011) that rates disease from a score of 0 (clear skin) to 4 (severe disease)|Week 12|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.|||Participants|||Count of Participants
2550835|NCT02825251|Secondary|Change From Baseline in Urinalysis: Protein|Reported results are urine protein-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
2550822|NCT02826603|Primary|Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response at Week 12|"Number of participants who achieved ≥ 90% reduction in PASI compared to baseline.~Logistic regression analysis of PASI 90 response at Week 12~PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, upper limbs, trunk, lower limbs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of body region(head: 0.1, upper limbs: 0.2, trunk: 0.3, lower limbs: 0.4)."|Week 12|The Full analysis set (FAS) is all patients from the randomized set assigned to study treatment. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned at randomization. If the actual randomization stratum was different to the assigned stratum in IRT, the actual stratum was used in the analyses.|||Participants|||Count of Participants
2550823|NCT02826551|Secondary|Pain Pill Count|Patients will log the number of pills they take the first four days after surgery.|Day 0-4 post-operatively|data was not collected.||||||
2550824|NCT02826551|Primary|VAS Scores|VAS Scales recorded in AM and PM|Day 0-4 post-operatively|data were not collected.||||||
2550825|NCT02826421|Secondary|Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D)|Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert preloaded delivery system and the Monarch III D delivery system. Only one eye (study eye) contributed to the analysis.|Day 0, operative day|Full Analysis Set|||mm||Standard Error|Mean
2550826|NCT02826421|Primary|Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)|Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert, iTec, and iSert preloaded delivery systems. Only one eye (study eye) contributed to the analysis.|Day 0, operative day|Full Analysis Set|||mm||Standard Error|Mean
2550827|NCT02825550|Secondary|Serum Level of AFP|Serum Level of AFP [Time Frame: Baseline serum AFP levels (168±383) compared with one or three months of serum levels of AFP (144±256) after Taiwan ACE Beads procedure]|Baseline serum AFP levels compared with one or three months of serum levels of AFP after Taiwan ACE Beads procedure||||ng/mL||Standard Deviation|Mean
2550828|NCT02825550|Primary|Tumor Response (Efficacy)|mRECIST criteria was used to evaluate tumor response in patients with hepatoma who received Taiwan ACE beads (T-ACE) microspheres embolization.|Before treatment, one month and three month after T-ACE using CT scan and MRI||||Participants|||Count of Participants
2550829|NCT02825550|Primary|Patients Survival (Safety)|Survival rate was evaluated since treatment day until the date of death or final observation.|An average of 12 weeks.||||Participants|||Count of Participants
2550830|NCT02825251|Secondary|Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets|"Number of subjects with at least one non-routine change-of-infusion-sets categorised by reasons for change-of-infusion-sets was evaluated from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.~Reasons for change-of-infusion-sets are categorised as follows:~Category-1: A perceived occlusion by the subject Category-2: Any problems related to the infusion set Category-3: Any technical issues with the pump Category-4: Changes in the insulin solution in the infusion set or reservoir Category-5: High BG with no other explanation which made the subject change the infusion set Category-6: Infusion site reaction Category-7: Missing"|Week 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
2550831|NCT02825251|Secondary|Number of Change-of-infusion-sets Per Week|Number of change-of-infusion-sets per week was evaluated from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of infusion-sets||Standard Deviation|Mean
2550832|NCT02825251|Secondary|Change From Baseline in Body Mass Index (BMI)|Change from baseline (week 0) in BMI was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||kg/m^2||Standard Deviation|Mean
2550833|NCT02825251|Secondary|Change From Baseline in Body Weight|Change from baseline (week 0) in body weight was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Kg||Standard Deviation|Mean
2550834|NCT02825251|Secondary|Change From Baseline in Urinalysis: Ketones|Reported results are urine ketone-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
2550850|NCT02825251|Secondary|Change From Baseline in Haematology: Haematocrit|Change from baseline (week 0) in haematocrit was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||% of haematocrit||Standard Deviation|Mean
2550836|NCT02825251|Secondary|Change From Baseline in Urinalysis: Erythrocytes|Reported results are urine erythrocytes-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ and e) 3+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
2550837|NCT02825251|Secondary|Change From Baseline in Urinalysis: Albumin/Creatine Ratio|Change from baseline (week 0) in albumin/creatine ratio was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||mg/mmol||Standard Deviation|Mean
2550838|NCT02825251|Secondary|Change From Baseline in Biochemistry: Total Bilirubin|Change from baseline (week 0) in bilirubin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||umol/L||Standard Deviation|Mean
2550839|NCT02825251|Secondary|Change From Baseline in Biochemistry: Albumin|Change from baseline (week 0) in albumin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||g/dL||Standard Deviation|Mean
2550840|NCT02825251|Secondary|Change From Baseline in Biochemistry: Potassium|Change from baseline (week 0) in potassium was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550841|NCT02825251|Secondary|Change From Baseline in Biochemistry: Sodium|Change from baseline (week 0) in sodium was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550842|NCT02825251|Secondary|Change From Baseline in Biochemistry: Alkaline Phosphatase (ALP)|Change from baseline (week 0) in ALP was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||U/L||Standard Deviation|Mean
2550843|NCT02825251|Secondary|Change From Baseline in Biochemistry: Aspartate Aminotransferase (AST)|Change from baseline (week 0) in AST was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||U/L||Standard Deviation|Mean
2550844|NCT02825251|Secondary|Change From Baseline in Biochemistry: Alanine Aminotransferase (ALT)|Change from baseline (week 0) in ALT was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||U/L||Standard Deviation|Mean
2550845|NCT02825251|Secondary|Change From Baseline in Biochemistry: Creatinine|Change from baseline (week 0) in creatinine was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||umol/L||Standard Deviation|Mean
2550846|NCT02825251|Secondary|Change From Baseline in Biochemistry: Total Protein|Change from baseline (week 0) in total protein was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||g/dL||Standard Deviation|Mean
2550847|NCT02825251|Secondary|Change From Baseline in Haematology: Leucocytes|Change from baseline (week 0) in leucocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||10^9/L||Standard Deviation|Mean
2550848|NCT02825251|Secondary|Change From Baseline in Haematology: Thrombocytes|Change from baseline (week 0) in thrombocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||10^9/L||Standard Deviation|Mean
2550849|NCT02825251|Secondary|Change From Baseline in Haematology: Erythrocytes|Change from baseline (week 0) in erythrocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||10^12/L||Standard Deviation|Mean
2550851|NCT02825251|Secondary|Change From Baseline in Haematology: Haemoglobin|Change from baseline (week 0) in haemoglobin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550852|NCT02825251|Secondary|Change From Screening in Fundus Photography/Fundoscopy|Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) AAbnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
2550853|NCT02825251|Secondary|Change From Screening in Electrocardiogram (ECG)|Reported results are ECG findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
2550854|NCT02825251|Secondary|Change From Baseline in Vital Sign: Pulse|Change from baseline (week 0) in pulse was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Beats/minute||Standard Deviation|Mean
2550855|NCT02825251|Secondary|Change From Baseline in Vital Sign: Blood Pressure|Change from baseline (week 0) in blood pressure (both systolic and diastolic) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||mmHg||Standard Deviation|Mean
2550856|NCT02825251|Secondary|Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck|Reported results are head, ears, eyes, nose, throat and neck-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
2550857|NCT02825251|Secondary|Change From Baseline in Physical Examination: Skin|Reported results are skin-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
2550858|NCT02825251|Secondary|Change From Baseline in Physical Examination: Musculoskeletal System|Reported results are musculoskeletal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
2550859|NCT02825251|Secondary|Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth|Reported results are gastrointestinal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
2550860|NCT02825251|Secondary|Change From Baseline in Physical Examination: Central and Peripheral Nervous System|Reported results are central and peripheral nervous system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
2550861|NCT02825251|Secondary|Change From Baseline in Physical Examination: Cardiovascular System|Reported results are cardiovascular system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
2551032|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 6||Week 6|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2550862|NCT02825251|Secondary|Change From Baseline in Physical Examination: Respiratory System|Reported results are respiratory system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of subjects|||Number
2550863|NCT02825251|Secondary|Number of Unexplained Episodes of Hyperglycaemia (Confirmed by SMPG)|Unexplained hyperglycaemia was defined as a confirmed PG value ≥16.7 mmol/L (300 mg/dL) and was unexplained (i.e. no apparent medical, dietary, insulin dosage or pump failure reason). The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
2550864|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal|Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 3 to 4 hours after start of the meal. The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
2550865|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal|Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 3 hours after start of the meal. The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
2550866|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal|Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 1 hour to 2 hours after start of the meal. The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
2550867|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal|Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 4 hours after start of the meal. The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
2550868|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal|Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 4 hours after start of the meal. The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
2550869|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal|Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 2 hours after start of the meal. The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
2550870|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal|Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 1 hour after start of the meal. The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
2550871|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)|Number of treatment emergent nocturnal hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 00:01 and 05:59 (both included). The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
2550872|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)|Number of treatment emergent day time hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 06:00 and 00:00 (both included). The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of hypoglycaemic episodes|||Number
2551033|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 5||Week 5|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2550873|NCT02825251|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall|"ADA classification of hypo:~Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.~Documented symptomatic: PG ≤3.9 mmol/L with symptoms.~Asymptomatic: PG ≤3.9 mmol/L without symptoms.~Probable symptomatic: No measurement with symptoms.~Pseudo: PG >3.9 mmol/L with symptoms.~Unclassifiable.~NN classification of hypo:~BG confirmed: PG <3.1 mmol/L with/without symptoms.~Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms.~Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms.~Unclassifiable.~Not able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypo."|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis. The results are based on the on-treatment period.|||Number of hypoglycaemic episodes|||Number
2550874|NCT02825251|Secondary|Number of Treatment Emergent Infusion Site Reactions|Number of treatment emergent infusion site reactions were recorded from week 0 to week 16. The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of infusion site reaction events|||Number
2550875|NCT02825251|Secondary|Number of Treatment Emergent Adverse Events (AEs)|Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 16. A TEAE was defined as an event that has an onset date on or after the first day of exposure to randomised treatment (in week 0), and no later than seven days after the last day of randomised treatment (i.e., maximum week 16 + 7 days). The results are based on the on-treatment period.|Weeks 0-16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Number of adverse events|||Number
2550876|NCT02825251|Secondary|Change From Baseline in IG Peak After Start of Meal|Change from baseline (week 0) in IG peak after start of meal-test meal was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550877|NCT02825251|Secondary|Change From Baseline in Time to the IG Peak After Start of Meal|Change from baseline (week 0) in time to the IG peak after start of meal-test meal was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||Minute||Standard Deviation|Mean
2550878|NCT02825251|Secondary|Change From Baseline in AUCIG,0-4h|Change from baseline (week 0) in AUCIG,0-24hours during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550879|NCT02825251|Secondary|Change From Baseline in AUCIG,0-2h|Change from baseline (week 0) in AUCIG,0-2 hours during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550880|NCT02825251|Secondary|Change From Baseline in AUCIG,0-1h|Change from baseline (week 0) in AUCIG,0-1 hour during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550881|NCT02825251|Secondary|Change From Baseline in AUCIG,0-30min|Change from baseline (week 0) in AUCIG,0-30 minutes during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550882|NCT02825251|Secondary|Change From Baseline in AUCIG,0-15min|Change from baseline (week 0) in area under the curve for interstitial glucose (AUCIG),0-15 minutes during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550883|NCT02825251|Secondary|Area Under the Curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL]|Area under the curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL] was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550884|NCT02825251|Secondary|Variation in the IG Profile|Variation in IG profile was the average absolute difference from the mean of the IG profile. Variation in the IG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Full Range|Median
2550885|NCT02825251|Secondary|Percentage of Time Spent Within IG Target Range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL)|Percentage of time spent within IG target range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||% of time||Standard Deviation|Mean
2551034|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2550886|NCT02825251|Secondary|Change From Baseline in Mean of the IG Profile|Change from baseline (week 0) in mean of the IG profile was evaluated after 16 weeks of randomisation. The mean of an IG profile is defined as the time integral of the profile over the profile's length, divided by the profile's length. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550887|NCT02825251|Secondary|Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])|Incidence of episodes with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||Number of Events|||Number
2550888|NCT02825251|Secondary|Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])|Percentage of time spent with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||% of time||Standard Deviation|Mean
2550889|NCT02825251|Secondary|Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)|Change from baseline (week 0) in mean IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550890|NCT02825251|Secondary|Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)|Change from baseline (week 0) in mean time to the IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||Minutes||Standard Deviation|Mean
2550891|NCT02825251|Secondary|Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal)|Change from baseline (week 0) in mean interstitial glucose (IG) increment (0-30 minutes (min), 0-1 hour (h) and 0-2 h after start of meal) (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550892|NCT02825251|Secondary|Insulin Delivery Pump Parameter: Active Insulin Time|Active insulin time was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Hour (h)||Standard Deviation|Mean
2550893|NCT02825251|Secondary|Insulin Delivery Pump Parameter: Glucose Sensitivity Factor|Glucose sensitivity factor was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L/U||Standard Deviation|Mean
2550894|NCT02825251|Secondary|Insulin Delivery Pump Parameter: Insulin Carbohydrate Ratio|Insulin carbohydrate ratio was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||Gram (g)/U||Standard Deviation|Mean
2550895|NCT02825251|Secondary|Insulin Dose in Units/kg/Day: Individual Meal Insulin Dose|No data was collected for individual meal insulin dose.|Week 16|No subjects were analysed, as no data was collected for individual meal insulin dose.||||||
2550896|NCT02825251|Secondary|Insulin Dose in Units/kg/Day: Total Daily Insulin Dose|Total insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||U/Kg||Standard Deviation|Mean
2550897|NCT02825251|Secondary|Insulin Dose in Units/kg/Day: Total Bolus|Total bolus insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||U/Kg||Standard Deviation|Mean
2550898|NCT02825251|Secondary|Insulin Dose in Units/kg/Day: Total Basal|Total basal insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||U/Kg||Standard Deviation|Mean
2550899|NCT02825251|Secondary|Insulin Dose in Units/Day: Individual Meal Insulin Dose|No data was collected for individual meal insulin dose.|Week 16|No subjects were analysed, as no data was collected for individual meal insulin dose.||||||
2551035|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 3||Week 3|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2550900|NCT02825251|Secondary|Insulin Dose in Units/Day: Total Daily Insulin Dose|Total insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||U||Standard Deviation|Mean
2550901|NCT02825251|Secondary|Insulin Dose in Units/Day: Total Bolus|Total bolus insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 16|The safety analysis set included all subjects receiving at least one dose of the IMP or its comparator. Number analyzed = Number of subjects contributed to the analysis.|||U||Standard Deviation|Mean
2550902|NCT02825251|Secondary|Insulin Dose in Units/Day: Total Basal|Total basal insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period: the observation period from date of first dose of randomised trial products (faster aspart and NovoRapid®) to no later than 7 days after the day of last dose of randomised trial products.|Week 16|The safety analysis set included all subjects receiving at least one dose of the investigational medicinal product (IMP, faster aspart) or its comparator (NovoRapid®/NovoLog®). Number analyzed = Number of subjects contributed to the analysis.|||Unit (U)||Standard Deviation|Mean
2550903|NCT02825251|Secondary|Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins)|Reported results are lipids-lipoproteins (total cholesterol, high density lipoproteins, low density lipoproteins) values at baseline (week 0) and after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Full Range|Median
2550904|NCT02825251|Secondary|Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] Without Severe Hypoglycaemia|Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] without treatment emergent severe hypoglycaemia was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. The results are based on the in-trial period.|Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||% of subjects|||Number
2550905|NCT02825251|Secondary|Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL]|Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period.|Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||% of subjects|||Number
2550906|NCT02825251|Secondary|Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements|Change from baseline (week 0) in nocturnal SMPG measurements was assessed by considering the differences between PG values available at bedtime, at 4 AM and the before breakfast value the following day: (4 AM PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 4 AM PG value). Change from baseline in nocturnal increments in SMPG measurements of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation and presented during three different time intervals as follows: 1) 04:00 to breakfast, 2) bedtime to 04:00, and 3) bedtime to breakfast. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550907|NCT02825251|Secondary|Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 Point Profile|Fluctuation in 7-point SMPG profile was the average absolute difference from the mean of the SMPG profile. Reported results are fluctuation in the 7-7-9 point SMPG profile at baseline (week 0) and after 16 weeks of randomisation (i.e., week 16). The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Full Range|Median
2550908|NCT02825251|Secondary|Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal)|Change from baseline (week 0) in pre-prandial PG (pre-breakfast, pre-lunch, pre-main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550909|NCT02825251|Secondary|Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)|Change from baseline (week 0) in PPG increment (breakfast, lunch, main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550910|NCT02825251|Secondary|Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)|Change from baseline (week 0) in PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2551036|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2550911|NCT02825251|Secondary|Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile|Change from baseline (week 0) in mean of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. 7-7-9 point SMPG was measured at the following mentioned time points: 1) Before breakfast, 2) 60 mins after the start of Breakfast, 3) Before lunch, 4) 60 mins after the start of lunch, 5) Before main evening meal, 6) 60 mins after the start of main evening meal, 7) At bedtime, 8) At 4 AM, 9) Before breakfast.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550912|NCT02825251|Secondary|Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)|Change from baseline (week 0) in 30-min, 2-hour, 3-hour and 4-hour PPG increment (meal test) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid®) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and PPG was evaluated after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550913|NCT02825251|Secondary|Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test)|Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour postprandial glucose (PPG [meal test]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid®) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550914|NCT02825251|Secondary|Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) Without Severe Hypoglycaemic Episodes|Percentage of subjects reaching HbA1c <7.0% (53 mmol/mol) without treatment emergent severe hypoglycaemic episodes was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of IMP administration after randomisation (in week 0) and no later than one day after the last day on IMP (i.e., maximum week 16 + 1 day). The results are based on the in-trial period.|Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||% of subjects|||Number
2550915|NCT02825251|Secondary|Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol)|Percentage of subjects reaching HbA1c <7.0% (53 mmol/mol) was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period.|Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||% of subjects|||Number
2550916|NCT02825251|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline (week 0) in FPG was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550917|NCT02825251|Secondary|Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM|Change from baseline (week 0) in low interstitial glucose (IG) (≤3.9 mmol/L [70 mg/dL]) during continuous glucose monitoring (CGM) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||min/day||Standard Deviation|Mean
2550918|NCT02825251|Secondary|Change From Baseline in 1,5-anhydroglucitol|Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||ug/mL||Standard Deviation|Mean
2550919|NCT02825251|Secondary|Change From Baseline in 1-hour PPG Increment|Change from baseline (week 0) in 1-hour postprandial glucose (PPG) increment was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, Week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2550920|NCT02825251|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline (week 0) in HbA1c was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.|Week 0, week 16|The FAS included all randomised subjects. Number analyzed = Number of subjects contributed to the analysis.|||Percentage (%) of HbA1c||Standard Deviation|Mean
2550921|NCT02824913|Secondary|Adverse Events|Number of patients experiencing adverse events comparing P-321 to placebo|2 or 7 hours|One subject enrolled in the study. Subject received both study treatments (a single instillation of 0.017% P-321 Ophthalmic Solution in both eyes and a single instillation of Placebo in both eyes).|||Participants|||Count of Participants
2551037|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 1||Week 1|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2555010|NCT02750267|Secondary|Mean BG (as Measured by CGM)|All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.|68 hours||||mg/dL||Standard Deviation|Mean
2550922|NCT02824913|Secondary|Comparison of Lower Tear Meniscus Height Measurements Between UHR-OCT and Keratograph 5M|Tear meniscus height of the inferior eyelid was measured by UHR-OCT and Keratograph 5M over time (0 to 6 hours) following the administration of placebo or P-321 Ophthalmic Solution|Pre-dose and up to six hours after dose|"One subject enrolled in the study. Subject received both study treatments (a single instillation of 0.017% P-321 Ophthalmic Solution in both eyes and a single instillation of Placebo in both eyes).~Study was terminated, raw data obtained. Processing of data was not conducted to obtain primary and secondary outcomes, therefore none reported."||||||
2550923|NCT02824913|Secondary|Lower Tear Meniscus Height as Measured by the Keratograph 5M|Tear meniscus height of the inferior eyelid was measured with the Keratograph 5M over time (0 to 6 hours) following the administration of placebo or P-321 Ophthalmic Solution|Pre-dose and up to six hours after dose|"One subject enrolled in the study. Subject received both study treatments (a single instillation of 0.017% P-321 Ophthalmic Solution in both eyes and a single instillation of Placebo in both eyes).~Study was terminated, raw data obtained. Processing of data was not conducted to obtain primary and secondary outcomes, therefore none reported."||||||
2550924|NCT02824913|Primary|Change in Total Tear Meniscus Volume Following the Administration of P-321 Ophthalmic Solution or Placebo|Tear meniscus volume, from measurements of tear meniscus area by UHR-OCT and the length of the eyelid was estimated over time (0 to 6 hours) following administration of placebo or P-321 Ophthalmic Solution.|Pre-dose and up to six hours after dose|"One subject enrolled in the study. Subject received both study treatments (a single instillation of 0.017% P-321 Ophthalmic Solution in both eyes and a single instillation of Placebo in both eyes).~Study was terminated, raw data obtained. Processing of data was not conducted to obtain primary and secondary outcomes, therefore none reported."||||||
2550925|NCT02824562|Secondary|Outcome Assessment Feasibility: Number (Percentage) of Participants Who Complete Outcome Assessments Within One Month|Outcome assessments are administered to participants by study staff.|From the conclusion of the intervention through 30 days (Intervention Group). From the last group session through 30 days (Control Group).|All 22 participants in each arm were analyzed.|||Participants|||Count of Participants
2550926|NCT02824562|Primary|Intervention Feasibility: Median Number of Study Intervention Sessions Attended by Participants|Participants are expected to attend 6 one-on-one sessions and 6 group sessions. Maximum sessions if all attended per participant would be 12 sessions.|From baseline throughout the entire 16 week intervention period|All 22 participants were assessed.|||Study Sessions||Inter-Quartile Range|Median
2550927|NCT02824432|Secondary|Number of Participants Reporting One or More AEs Related to Laboratory Tests of Fasting Plasma Glucose||Up to Week 8|Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.|||Participants|||Count of Participants
2550928|NCT02824432|Secondary|Number of Participants Reporting One or More AEs Related to Pulse in the Sitting Position||Up to Week 8|Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.|||Participants|||Count of Participants
2550929|NCT02824432|Secondary|Number of Participants Reporting One or More AEs Related to Blood Pressure in the Sitting Position||Up to Week 8|Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.|||Participants|||Count of Participants
2550930|NCT02824432|Secondary|Number of Participants Reporting One or More AEs Related to Body Weight||Up to Week 8|Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.|||Participants|||Count of Participants
2550931|NCT02824432|Secondary|Number of Participants Reporting One or More Adverse Events (AEs)||Up to Week 8|Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.|||Participants|||Count of Participants
2550932|NCT02824432|Secondary|Percent Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8|Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in DHA/AA ratio at each time point.|Prior to meal at Baseline and Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percent of Change||Standard Deviation|Mean
2550933|NCT02824432|Secondary|Change From Baseline in DHA/AA Ratio With Fasting State at Week 4 and Week 8|Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in DHA/AA ratio at each time point.|Prior to meal at Baseline and Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Ratio||Standard Deviation|Mean
2550934|NCT02824432|Secondary|Docosahexaenoic Acid to Arachidonic Acid (DHA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8|Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition.|Prior to meal at Baseline, Week 4 and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Ratio||Standard Deviation|Mean
2550935|NCT02824432|Secondary|Percent Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8|Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in EPA/AA Ratio at each time point.|Prior to meal at Baseline and Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percent of Change||Standard Deviation|Mean
2550936|NCT02824432|Secondary|Change From Baseline in EPA/AA Ratio With Fasting State at Week 4 and Week 8|Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in EPA/AA Ratio at each time point.|Prior to meal at Baseline and Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Ratio||Standard Deviation|Mean
2550937|NCT02824432|Secondary|Eicosapentaenoic Acid to Arachidonic Acid (EPA/AA) Ratio With Fasting State at Baseline, Week 4 and Week 8|Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition.|Prior to meal at Baseline, Week 4 and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Ratio||Standard Deviation|Mean
2550938|NCT02824432|Secondary|Percent Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8|Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Docosahexaenoic acid at each time point.|Prior to meal at Baseline and Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percent of Change||Standard Deviation|Mean
2550939|NCT02824432|Secondary|Change From Baseline in Docosahexaenoic Acid Concentration With Fasting State at Week 4 and Week 8|Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Docosahexaenoic acid at each time point.|Prior to meal at Baseline and Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||μg/mL||Standard Deviation|Mean
2550940|NCT02824432|Secondary|Docosahexaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8|Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.|Prior to meal at Baseline, Week 4 and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||μg/mL||Standard Deviation|Mean
2550941|NCT02824432|Secondary|Percent Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8|Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Eicosapentaenoic acid at each time point.|Prior to meal at Baseline and Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percent of Change||Standard Deviation|Mean
2550942|NCT02824432|Secondary|Change From Baseline in Eicosapentaenoic Acid Concentration With Fasting State at Week 4 and Week 8|Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Eicosapentaenoic acid at each time point.|Prior to meal at Baseline and Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||μg/mL||Standard Deviation|Mean
2550943|NCT02824432|Secondary|Eicosapentaenoic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8|Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.|Prior to meal at Baseline, Week 4 and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||μg/mL||Standard Deviation|Mean
2550944|NCT02824432|Secondary|Percent Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8|Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Arachidonic acid at each time point.|Prior to meal at Baseline and Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percent of Change||Standard Deviation|Mean
2550945|NCT02824432|Secondary|Change From Baseline in Arachidonic Acid Concentration With Fasting State at Week 4 and Week 8|Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Arachidonic acid at each time point.|Prior to meal at Baseline and Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||μg/mL||Standard Deviation|Mean
2551038|NCT02822794|Secondary|Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)|SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2550946|NCT02824432|Secondary|Arachidonic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8|Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.|Prior to meal at Baseline, Week 4 and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||μg/mL||Standard Deviation|Mean
2550947|NCT02824432|Secondary|Percent Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8|Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the percent change from baseline in Dihomo-gamma-linolenic acid at each time point.|Prior to meal at Baseline and Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percent of Change||Standard Deviation|Mean
2550948|NCT02824432|Secondary|Change From Baseline in Dihomo-gamma-linolenic Acid Concentration With Fasting State at Week 4 and Week 8|Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the change from baseline in Dihomo-gamma-linolenic acid at each time point.|Prior to meal at Baseline and Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||μg/mL||Standard Deviation|Mean
2550949|NCT02824432|Secondary|Dihomo-gamma-linolenic Acid Concentration With Fasting State at Baseline, Week 4 and Week 8|Samples for plasma fatty acid fractions (Dihomo-gamma-linolenic acid, Arachidonic acid, Eicosapentaenoic acid, Docosahexaenoic acid, EPA/AAratio, and DHA/AAratio) were taken under the fasting condition. Reported data was the observation value at each point.|Prior to meal at Baseline, Week 4 and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||microgram (μg)/milliliter (mL)||Standard Deviation|Mean
2550950|NCT02824432|Secondary|Percent Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8||4-hours after meal at Baseline and Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percent of Change||Standard Deviation|Mean
2550951|NCT02824432|Secondary|Change From Baseline in TG Level With 4-Hours Postprandial State at Week 4 and Week 8||4-hours after meal at Baseline and Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||mg/dL||Standard Deviation|Mean
2550952|NCT02824432|Secondary|TG Level With 4-Hours Postprandial State at Baseline, Week 4 and Week 8||4-hours after meal at Baseline, Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||mg/dL||Standard Deviation|Mean
2550953|NCT02824432|Secondary|Percent Change From Baseline in TG Level With Fasting State at Week 4 and Week 8||Prior to meal at Baseline and Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percent of Change||Standard Deviation|Mean
2550954|NCT02824432|Secondary|Change From Baseline in TG Level With Fasting State at Week 4 and Week 8||Prior to meal at Baseline and Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||mg/dL||Standard Deviation|Mean
2550955|NCT02824432|Secondary|Triglyceride (TG) Level With Fasting State at Baseline, Week 4, and Week 8||Prior to meal at Baseline, Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||mg/dL||Standard Deviation|Mean
2550956|NCT02824432|Secondary|Percent Change From Baseline in FMD With 4-Hours Postprandial State at Week 8|FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.|4-hours after meal at Baseline and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percent of Change||Standard Deviation|Mean
2550957|NCT02824432|Secondary|Change From Baseline in FMD With 4-Hours Postprandial State at Week 8|FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.|4-hours after meal at Baseline and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percentage of dilation||Standard Deviation|Mean
2551039|NCT02822794|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2551040|NCT02822794|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set|||percentage of participants|||Number
2550958|NCT02824432|Secondary|FMD With 4-Hours Postprandial State at Baseline and Week 8|FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.|4-hours after meal at Baseline and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percentage of dilation||Standard Deviation|Mean
2550959|NCT02824432|Primary|Percent Change From Baseline in FMD With Fasting State at Baseline, Week 4 and Week 8|FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.|Prior to meal at Baseline and Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percent of Change||Standard Deviation|Mean
2550960|NCT02824432|Primary|Change From Baseline in FMD With Fasting State at Week 4 and Week 8|FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.|Prior to meal at Baseline and Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percentage of dilation||Standard Deviation|Mean
2550961|NCT02824432|Primary|Flow-mediated Dilation (FMD) With Fasting State at Baseline, Week 4 and Week 8|FMD refers to dilation (widening) of an artery when blood flow increases in that artery. To determine FMD, brachial artery dilation following a transient period of forearm ischemia is measured using ultrasound. FMD was calculated by the value of Maximum diastolic vessel size minus vessel size at rest, divided by vessel size at rest, described with percentage.|Prior to meal at Baseline, Week 4, and Week 8|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percentage of dilation||Standard Deviation|Mean
2550962|NCT02824224|Other Pre-specified|Longest Bleed-free Interval||60 days after initiation of study drug|Study ended up only collecting 30-day follow up data||||||
2550963|NCT02824224|Other Pre-specified|Number of Prolonged Bleeding Episodes (>8 Days)||60 days after initiation of study drug|Study ended up only collecting 30-day follow up data||||||
2550964|NCT02824224|Other Pre-specified|Total Number of Bleeding/Spotting Episodes||60 days after initiation of study drug|Study ended up only collecting 30-day follow up data||||||
2550965|NCT02824224|Secondary|Adverse Events|Descriptive reporting of adverse events for each arm|30 days after initiation of study drug|"Adverse event information is reported in Adverse Event section of record summary."|||Events|||Number
2550966|NCT02824224|Secondary|IUD Satisfaction|0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with IUD (intrauterine device). 0 mm = not at all satisfied, 100 mm = very satisfied.|30 days after initiation of study drug|Only 30 women completed the side effect, satisfaction and acceptability survey (n=15 placebo and n=15 tamoxifen).|||units on a scale||Standard Deviation|Mean
2550967|NCT02824224|Secondary|Bleeding Pattern Satisfaction|0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with bleeding pattern. 0 mm = not at all satisfied, 100 mm = very satisfied.|30 days after initiation of study drug|Only 30 women completed the side effect, satisfaction and acceptability survey (n=15 placebo and n=15 tamoxifen).|||units on a scale||Standard Deviation|Mean
2550968|NCT02824224|Primary|Number of Bleeding and Spotting Days|Mean number of bleeding and spotting days in the tamoxifen group compared to the mean number of bleeding and spotting days in the placebo group|30 days after initiation of study drug||||days||Standard Deviation|Mean
2550969|NCT02824198|Secondary|Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo|Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: >=39 degree Celsius; Headache, Malaise, Myalgia, and Asthenia: significant, prevents daily activity.|Within 14 days after booster injection|Analysis was performed on Safety Analysis Set. Here, ‘number analyzed’ = participants with available data for specified category.|||Participants|||Count of Participants
2550970|NCT02824198|Secondary|Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo|Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 injection site reactions: Pain: significant; prevents daily activity; Erythema and Swelling: >100 millimeter.|Within 7 days after booster injection|Analysis was performed on Safety Analysis Set which included all participants who received either CYD dengue vaccine or placebo. Here, ‘number analyzed’ = participants with available data for specified category.|||Participants|||Count of Participants
2550971|NCT02824198|Secondary|Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo|Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers >=10 (1/dilution).|6 months, 12 months, and 24 months post-booster injection|Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.|||percentage of participants|||Number
2551041|NCT02822794|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2550972|NCT02824198|Secondary|GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo|GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT. GMTRs were calculated as the ratio of GMTs post-booster injection and pre-booster injection.|Pre-booster injection (Day 0) and 6 months, 12 months, 24 months post-booster injection|Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.|||ratio||95% Confidence Interval|Geometric Mean
2550973|NCT02824198|Secondary|GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo|GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT.|6 months, 12 months, and 24 months post-booster injection|Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.|||titers (1/dilution)||95% Confidence Interval|Geometric Mean
2550974|NCT02824198|Secondary|Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo|Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers >=10 (1/dilution).|28 days post-dose 3 in CYD28 and 28 days post-booster injection in CYD63|Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.|||percentage of participants|||Number
2550975|NCT02824198|Secondary|GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD28 And Before Booster Injection With Either CYD Dengue Vaccine or Placebo|GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the PRNT. GMTRs were calculated as the ratio of GMTs post-dose 3 in CYD28 and pre-booster injection in CYD63.|28 days post-dose 3 in CYD28 and pre-booster injection (Day 0) in CYD63|Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed'=participants with available data for each specified category.|||ratio||95% Confidence Interval|Geometric Mean
2550976|NCT02824198|Secondary|GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received In Study CYD28 and Before Booster Injection With Either CYD Dengue Vaccine or Placebo in CYD63|GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the PRNT.|28 days post-dose 3 in CYD28 and pre-booster injection (Day 0) in CYD 63|Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.|||titers (1/dilution)||95% Confidence Interval|Geometric Mean
2550977|NCT02824198|Secondary|Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo|Seroconversion rates for each serotypes were defined as the percentages of participants with either a pre-booster titer < 10 (1/dilution) and a post-booster titer >= 40 (1/dilution), or a pre-booster titer >=10 (1/dilution) and a >= 4-fold increase in post-booster titer as determined by PRNT.|28 days post-booster injection|Analysis was performed on Per-Protocol Analysis Set.|||percentage of participants|||Number
2550978|NCT02824198|Secondary|Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo|Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers >=10 (1/dilution).|Pre-booster injection (Day 0) and 28 days post-booster injection|Analysis was performed on Per-Protocol Analysis Set.|||percentage of participants|||Number
2550979|NCT02824198|Secondary|GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo|GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT. GMTRs were calculated as the ratio of GMTs post-booster injection and pre-booster injection.|Pre-booster injection (Day 0) and 28 days post-booster injection|Analysis was performed on Per-Protocol Analysis Set.|||ratio||95% Confidence Interval|Geometric Mean
2550980|NCT02824198|Secondary|GMTs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo|GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT.|Pre-booster injection (Day 0) and 28 days post-booster injection|Analysis was performed on Per-Protocol Analysis Set.|||titers (1/dilution)||95% Confidence Interval|Geometric Mean
2550981|NCT02824198|Primary|Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD63 Compared to the Third CYD Dengue Vaccine Injection Received in Study CYD28: CYD Dengue Vaccine Booster Group|GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the plaque reduction neutralization test (PRNT).|28 days post-dose 3 in CYD28 and 28 days post-booster injection in CYD63|Analysis was performed on Per-Protocol Analysis Set which included all participants who had no protocol deviations from the present study (CYD63). Here, ‘number analyzed’ = participants with available data for each specified category.|||titers (1/dilution)||95% Confidence Interval|Geometric Mean
2550982|NCT02823964|Primary|Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities|Descriptive analysis|12 months||||Participants|||Count of Participants
2550983|NCT02823600|Post-Hoc|Number of Diabetic Dialysis Subjects Undergoing Retinal Exam During Study Using the RetinaVue 100 Camera||Up to as much as one year after study enrollment|Diabetic dialysis participants|||Participants|||Count of Participants
2550984|NCT02823600|Secondary|Pre-and Post-eye Exam Rates in the Diabetic Dialysis Population|Changes in eye exam rates of the diabetic subset of total population from baseline (i.e. study entry) and post-enrollment in study. Baseline data were to be obtained from the UNC electronic medical record (EMR) as the number of participants with eye exams within the past year and post data would consist of the number of participants completing a study exam.|Baseline and post retinal eye exam|Baseline retinal examination data were not present within the EMR; therefore, this analysis could not be performed.||||||
2556674|NCT02721147|Primary|Feasibility of the Treatment as Measured Through Study Attrition|Feasibility of treatment is measured through the number of randomized participants who completed the study.|Up to 8 weeks||||Participants|||Count of Participants
2550985|NCT02823600|Secondary|Participant Satisfaction|Participant satisfaction survey data to be collected following the completion of retinal eye exam. Participants will be assessed on participant satisfaction measures such as comfort of experience, recovery time, and time invested in undergoing procedure vs. traditional retinal exam methods. The survey utilized a five-point Likert scale with the following responses: (1) strongly agree, (2) agree, (3) neutral, (4) disagree, (5) strongly disagree. The outcome measure is reported percentages for each of the six survey components.|Post retinal eye exam|This analysis is based on responses from the 39 that completed the survey.|||Percentage of participants|||Number
2550986|NCT02823600|Secondary|Overall Retinopathy in a Dialysis Population|Number of participants found to have retinopathy in a dialysis population|Post retinal eye exam||||Participants|||Count of Participants
2550987|NCT02823600|Primary|Usability of the RetinaVue Hand-Held 100 Camera|Usability of RetinaVue camera assessed by determining the number and percentage of inadequate images and the number and percentage of adequate images.|baseline visit||||Retinal Images|Retinal Images||Count of Units
2550988|NCT02823470|Secondary|Number of Participants With Greater Than or Equal to (>=) 90 Percent (%) Adherence|Number of participants with >=90% adherence to LUM/IVA treatment over 12 weeks were reported.|Up to Week 12|"FAS included randomized participants who received at least 1 dose of study drug. Overall Number of Participants Analyzed signifies those participants who had at least 12 weeks of eligible smart pill bottle data."|||Participants|||Count of Participants
2550989|NCT02823470|Secondary|Number of Participants With Greater Than or Equal to (>=) 80 Percent (%) Adherence|Number of participants with >=80% adherence to LUM/IVA treatment over 12 weeks were reported.|Up to Week 12|"FAS included randomized participants who received at least 1 dose of study drug. Overall Number of Participants Analyzed signifies those participants who had at least 12 weeks of eligible smart pill bottle data."|||Participants|||Count of Participants
2550990|NCT02823470|Secondary|Percentage Adherence to Lumacaftor/Ivacaftor (LUM/IVA) Treatment Through 12 Weeks|Percentage adherence was reported in terms of median and full range due to small sample size.|Up to Week 12|"FAS included randomized participants who received at least 1 dose of study drug. Overall Number of Participants Analyzed signifies those participants who had at least 12 weeks of eligible smart pill bottle data."|||percentage of adherence||Full Range|Median
2550991|NCT02823470|Primary|Percentage Adherence to Lumacaftor/Ivacaftor (LUM/IVA) Treatment|Percentage adherence was reported in terms of median and full range due to small sample size.|Up to 35 weeks|Full analysis set (FAS) included randomized participants who received at least 1 dose of study drug.|||percentage of adherence||Full Range|Median
2550992|NCT02823431|Secondary|Visual Analog Scale Scores (Measure of Discomfort) After Catheterization|visual analog scales were performed to evaluate discomfort at specified time points during the urodynamic studies. The scale is 1-100mm, with higher numbers indicating greater discomfort.|duration of urodynamic study, 2 hours||||mm||Standard Deviation|Mean
2550993|NCT02823431|Secondary|Number of Participants With Interrupted Urinary Flow Pattern During Micturition|presence of interrupted flow during micturition|duration of urodynamic study, 2 hours||||Participants|||Count of Participants
2550994|NCT02823431|Secondary|Detrusor Pressure at Maximum Flow|bladder pressure reading (mmHg) during maximum flow during micturition|duration of urodynamic study, 2 hours||||cmH2O||Standard Deviation|Mean
2550995|NCT02823431|Primary|Voiding Efficiency|voided volume/{voided volume + residual volume} during micturition study during urodynamic studies|duration of urodynamic study, 2 hours||||Percent voiding efficiency||Standard Deviation|Mean
2550996|NCT02823080|Other Pre-specified|Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy|-severity grades of gastrointestinal manifestations determined at Day -0,Day -3 and Day -6.|0-6 days||||GI manifestations|||Number
2550997|NCT02823080|Secondary|Daily Total Leucocytic Count|TLC(x 1ooo cells/ml)|0 -8days.||||1000 cells/ml||Standard Deviation|Mean
2550998|NCT02823080|Secondary|Ultrasound Detected Severity Grades of Ascites From Days 0-8|-US detected severity grades of ascites determined at Day -0, Day -3 and Day -8.|0-8 days||||US detected ascitis|||Number
2550999|NCT02823080|Secondary|Daily Hematocrits Value|Blood samples were obtained under complete aseptic condition for determination of hematocrits value (Ht%)|0-8 days.||||percentge||Standard Deviation|Mean
2551000|NCT02823080|Secondary|Daily Numerical Pain Visual Analogue Scale Score|-All patients were clinically evaluated for the presence of abdominal pain and if present was graduated using a numerical pain visual analogue scale (VAS) with 0 means no pain and 10 means severe intolerable pain .|8 days.||||units on a scale||Standard Deviation|Mean
2551001|NCT02823080|Primary|Daily Maximal Ovarian Diameter|MOD (maximal ovarian diameter in mm) were evaluated daily.|8 days||||mm||Standard Deviation|Mean
2551002|NCT02823080|Primary|Daily Serum E2 Levels|Serum E2 levels (Serum E2 level in picograms/ml) were evaluated daily.|8 days||||picograms/ml||Standard Deviation|Mean
2551003|NCT02822950|Primary|Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Maximum Serum Concentration in Intensive Care Patients||2,4,6, 8 hours after receiving the drug||||mg/liter||Standard Deviation|Mean
2551004|NCT02822950|Primary|Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Area Under Serum Curve (mg*h/L) Parameter in Intensive Care Patients||2,4,6, 8 hours after receiving the drug||||mg*hour/liters||Standard Deviation|Mean
2551005|NCT02822950|Primary|Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Clearance of Drug Parameter in Intensive Care Patients||2,4,6, 8 hours after receiving the drug||||Liters/hour||Standard Deviation|Mean
2551006|NCT02822950|Primary|Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Half Life Parameter in Intensive Care Patients||2,4,6, 8 hours after receiving the drug||||Hours||Standard Deviation|Mean
2551007|NCT02822950|Primary|Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Volume of Distribution Parameter in Intensive Care Patients||2,4,6, 8 hours after receiving the drug||||Liter||Standard Deviation|Mean
2551008|NCT02822885|Primary|Endometrial Thickness According to Histological Diagnosis|Endometrial Thickness was assessed by measuring the trilaminar halo of the Endometrial Thickness by trans vaginal sonography|2 weeks|"All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)~Endometrial polyp(N=17)~Hyperplasia(N=28)~Non-specific(N=15) B-Malignant lesion(N=10)"|||millimeter||Standard Deviation|Mean
2551009|NCT02822885|Primary|Uterine Artery Pulsatility Index According to Histological Diagnosis|Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance|2 weeks|"All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)~Endometrial polyp(N=17)~Hyperplasia(N=28)~Non-specific(N=15) B-Malignant lesion(N=10)"|||index||Standard Deviation|Mean
2551010|NCT02822885|Primary|Uterine Artery Resistive Index According to Histological Diagnosis|The primary outcome measures is uterine artery resistive index (RI) .In ultrasonography,it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity.lower values are better than higher values.|two weeks|"All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)~Endometrial polyp(N=17)~Hyperplasia(N=28)~Non-specific(N=15) B-Malignant lesion(N=10)"|||index||Standard Deviation|Mean
2551011|NCT02822885|Primary|Resistive Indices (PI) of Spiral Artery According to Histological Diagnosis|The primary outcome measure is spiral artery resistive index (RI) .In ultrasonography,it can be calculated from the peak systolic velocity and end diastolic velocity of blood flow and is calculated with the following formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity.lower values are better than higher values.|two weeks|"All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)~Endometrial polyp(N=17)~Hyperplasia(N=28)~Non-specific(N=15) B-Malignant lesion(N=10)"|||index||Standard Deviation|Mean
2551012|NCT02822885|Primary|Pulsatility Indices (PI) of Spiral Artery According to Histological Diagnosis|Pulsatility index is a measure of the variability of blood velocity in a vessel, and was calculated as the difference between the peak systolic and end diastolic velocities divided by the mean velocity during the cardiac cycle. Higher values are indicative of increased vascular resistance|two weeks|"All patients(N=70) were subdivided according to histological diagnosis to A-Benign lesion (N=60)~Endometrial polyp(N=17)~Hyperplasia(N=28)~Non-specific(N=15) B-Malignant lesion(N=10)"|||index||Standard Deviation|Mean
2551013|NCT02822794|Secondary|Percentage of Participants With Overall Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2551014|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 24||Baseline; Week 24|Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2551015|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 20||Baseline; Week 20|Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2551016|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 16||Baseline; Week 16|Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2551017|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 12||Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2551018|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 10||Baseline; Week 10|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2551019|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2551020|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2551021|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 5||Baseline; Week 5|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2551022|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2551023|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 3||Baseline; Week 3|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2551024|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2551025|NCT02822794|Secondary|Change From Baseline in HCV RNA at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2551026|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 24||Week 24|Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2551027|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 20||Week 20|Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2551028|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 16||Week 16|Participants in the Full Analysis Set from the SOF/VEL+RBV 24 Weeks Group with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2551029|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2551030|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 10||Week 10|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2551031|NCT02822794|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2551043|NCT02822612|Secondary|Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire|Participants rated ease of use, duration, and appeal on a 5-point Likert scale in a post-test questionnaire.|6 months|Results based on a post-test questionnaire. Participants rated ease of use (from 1 to 5: 1 = very difficult, 5 = very easy), duration (from 1 to 5: 1 = very long, 5 = very short), and appeal (from 1 to 5: 1 = very unappealing, 5 = very appealing) on a 5-point Likert scale.|||Participants|||Count of Participants
2551044|NCT02822612|Primary|Total Examination Time|Total time for each participant to complete the binocular optical coherence tomography (OCT) examination was calculated.|6 months||||seconds||Inter-Quartile Range|Median
2551045|NCT02822287|Secondary|Local Oral Tolerability|Local oral tolerability was assessed by performing oropharyngeal examination as follows: Results of oropharyngeal examination (Normal and abnormal); If abnormal, any signs of lesion on oral mucosa or irritation of oral mucosa.|Day 1 (at screening and end of study)|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.|||Participants|||Number
2551046|NCT02822287|Secondary|Number of Participants With Overall Opinion of Oral Solution|Overall opinion of oral solution was measured by scale: 4 = Excellent; 3 = Good; 2 = Fair; 1 = Poor; 0 = Unacceptable.|1 hour post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.|||Number of Participants|||Number
2551047|NCT02822287|Secondary|Number of Participants With Overall Opinion of Warming Sensation|Overall opinion of warming sensation was measured by scale: 9= Like extremely; 8= Like very much; 7= Like moderately; 6= Like slightly; 5= Neither like nor dislike; 4= Dislike slightly; 3= Dislike moderately; 2= Dislike very much; 1= Dislike extremely|10 minutes post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.|||Number of Participants|||Number
2551048|NCT02822287|Secondary|Number of Participants With Acceptability of Warming Sensation|Acceptability of strength of warming sensation was measured by a scale: 5= Much too strong; 4=Too strong (too warming); 3= Just about right (pleasant warming); 2= Too weak (not warming enough); 1= Much too weak|10 minutes post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.|||Number of Participants|||Number
2551049|NCT02822287|Primary|Warming Sensation Intensity at Pre-Dose and 60 Sec (Seconds) Post-Dose|"Warming Sensation Intensity was measured on 100 mm visual analogue scale (VAS), marked as no warming sensation on the left hand side (= 0 mm) and strongest possible warming sensation at the right hand side (=100 mm) at pre-dose."|Pre-dose and 60 sec post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.|||Millimeters (mm)||Standard Deviation|Mean
2551050|NCT02822287|Primary|Duration of Warming Sensation|Duration of action of warming sensation was measured by two stop watches started when the participants took the oral solution. First watch was stopped at the start of warming sensation and the second watch was stopped at the end. If onset of warming sensation occurred within 10 minutes of dosing but had not ended by the end of 10 minutes following dosing, then the duration was censored at 10 minutes minus the time to onset|10 minutes post-dose|The safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint and safety analysis. Of the 57 subjects in the Safety Population, 53 reported an onset of a warming sensation within10 minutes after dosing.|||Minutes||Full Range|Median
2551051|NCT02822287|Primary|Onset of Warming Sensation|Onset and duration of action of warming sensation was measured by two stop watches started when the participants took the oral solution. First watch was stopped at the start of warming sensation and the second watch was stopped at the end. If onset had not occurred by 10 minutes then time to onset was censored at 10 minutes. 53 of the 57 participants had onset within 10 minutes after dosing.|10 minutes post-dose|The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.|||Minutes||Full Range|Median
2551052|NCT02822235|Secondary|Percentage of Participants Who Used Healthcare Resources|Healthcare resources used in the previous 3 years included imaging and laboratory testing, surgeries, hospitalizations, and consultations.|Day 1|Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).|||percentage of participants|||Number
2551053|NCT02822235|Secondary|Mean of Percentage of Total Activity Impairment Due to CD as Assessed by WPAI|Mean total activity impairment due to IBD from WPAI questionnaire was reported. The 'overall work impairment due to IBD' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days; (Q4) the number of actual work hours in the past seven days; and (Q5) to what degree did the disease impair the productivity while working past seven days. The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Day 1|Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).|||percentage of total activity impairment||Standard Deviation|Mean
2551054|NCT02822235|Secondary|Mean of Percentage of Impairment While Working Due to CD as Assessed by WPAI at Day 1|Mean impairment while working due to IBD from WPAI questionnaire was reported. The 'impairment while working due to IBD' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. ata are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Day 1|Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).|||percentage of impairment while working||Standard Deviation|Mean
2551055|NCT02822235|Secondary|Mean of Percentage of Work Time Missed Due to CD as Assessed by WPAI at Day 1|Mean total activity impairment due to IBD from WPAI questionnaire was reported. The 'overall work impairment due to IBD' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days; (Q4) the number of actual work hours in the past seven days; and (Q5) to what degree did the disease impair the productivity while working past seven days. The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Day 1|Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).|||percentage of work time missed||Standard Deviation|Mean
2551056|NCT02822235|Secondary|Mean of Percentage of Total Work Impairment Due to CD as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire at Day 1|The Work Productivity and Activity Impairment questionnaire (WPAI) assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The 'impairment while working due to IBD' was calculated based on one question: to what degree did the disease impair the productivity while working in the past seven days from visit and the 'activity impairment' was calculated based on Question: how much did the disease affect ability to perform regular daily activities, other than work at a job? Percentage of overall work impairment due to IBD is calculated as: Absenteeism+(1-Absenteeism)*Presenteeism. The total score ranges from 0 (no impairment) to 100% (total loss of work productivity).|Day 1|Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment). Number analyzed is the number of participants with evaluable data at the given time-point.|||percentage of total work impairment||Standard Deviation|Mean
2551057|NCT02822235|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1|The Inflammatory Bowel Disease Questionnaire (IBDQ) was a 32-item questionnaire that measures 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question presented seven possible answers/points. Each domain score was the average of 8 responses each ranging from 1 to 7, where 1 indicated worst function and 7 the best function. The IBDQ was not validated for participants with colostomies and therefore was not be applied for these participants.|Day 1|Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment). Number analyzed is the number of participants with evaluable data at the given time-point.|||score on a scale||Standard Deviation|Mean
2551058|NCT02822235|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Day 1|The Inflammatory Bowel Disease Questionnaire (IBDQ) was a 32-item questionnaire that measures 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question presented seven possible answers/points. Each domain score was the sum of 8 responses each ranging from 1 to 7, where 1 indicated worst function and 7 the best. The total score ranged from 32 to 224, with higher scores representing better quality of life. The IBDQ was not validated for participants with colostomies and therefore was not be applied for these participants.|Day 1|Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment). Number analyzed is the number of participants with evaluable data at the given time-point.|||score on a scale||Standard Deviation|Mean
2551059|NCT02822235|Secondary|Quality of Life as Assessed by 36-Item Short Form Health Survey (SF-36) Component Score at Day 1|The Short Form-36 (SF-36) is a questionnaire that evaluates a participant's health related quality of life. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life.|Day 1|Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).|||score on a scale||Standard Deviation|Mean
2551060|NCT02822235|Secondary|Quality of Life as Assessed by European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Day 1|EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants.|Day 1|Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).|||score on a scale||Standard Deviation|Mean
2551061|NCT02822235|Secondary|Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason|One participant could have more than one reason for discontinuation.|Month 12|Longitudinal population included all participants who were eligible for the prospective period (participants with active IBD at Day 1).|||percentage of participants|||Number
2551062|NCT02822235|Secondary|Partial Mayo Score in Participants Who Had Moderate to Severe Active UC at Day 1 and Month 12|The mayo score without endoscopy measured severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician's global assessment were each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores were then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease).|Day 1 and Month 12|Longitudinal population included all participants who were eligible for the prospective period. Participants with active UC with data available for analysis at Day 1 and Month 12 were observed for this outcome measure.|||score on a scale||Standard Deviation|Mean
2551074|NCT02822235|Secondary|Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years|Therapies for IBD included aminosalicylates, steroids, immunossupressors, biologics, antibiotics, surgeries and others. One participant could use more than one therapy.|Within the previous 3 years including Day 1|Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).|||percentage of participants|||Number
2551063|NCT02822235|Secondary|Crohn´s Disease Activity Index (CDAI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12|CDAI evaluated the severity of signs and symptoms of CD. Collected data included information on the number of liquid stools, intensity of abdominal pain, general well-being, presence of comorbid conditions, use of medications for diarrhea, physical examination, and laboratory findings (abdominal mass, hematocrit, body weight), yielding 8 items that were combined with data from a 7-day diary to obtain the total CDAI score which ranges from 0 to approximately 600 points, where higher score indicates higher disease activity.|Day 1 and Month 12|Longitudinal population included all participants who were eligible for the prospective period. Participants with active CD with data available for analysis at Day 1 and Month 12 were observed for this outcome measure.|||score on a scale||Standard Deviation|Mean
2551064|NCT02822235|Secondary|Harvey Bradshaw Index (HBI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12|HBI scale assessed the severity of CD. HBI scale assessed five dimensions (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). These dimensions were scored from the previous day. The total score ranges from 0 to 25. Higher score indicates higher disease activity.|Day 1 and Month 12|Longitudinal population included all participants who were eligible for the prospective period. Participants with active CD with data available for analysis at Day 1 and Month 12 were observed for this outcome measure.|||score on a scale||Standard Deviation|Mean
2551065|NCT02822235|Secondary|Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables|Treatment variables include previous treatments or regimens (aminosalicylates, steroids, immunomodulators, immunossupressors, biologics, antibiotics); and previous surgeries for IBD. One participant could use more than one treatment regimens.|Day 1|Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).|||percentage of participants|||Number
2551066|NCT02822235|Secondary|Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables|Clinical variables included IBD type:CD/UC; Family history; Smoking habits; Medical History/Comorbidities; Extension of inflammation as E1=distal UC: proctitis or E1=distal UC: proctosigmoiditis extension of inflammation E2/E3=left-sided: mucosa inflammation extending up to splenic flexure or E3=pancolitis: mucosa inflammation up to proximal transverse colon and beyond extension of inflammation and severity of UC as S0=Clinical remission, S1=Mild UC, S2=Moderate UC, S3=Severe UC. Steroid behavior; Colonoscopy, Calprotectin levels >200ug/g.|Day 1|Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).|||Participants|||Count of Participants
2551067|NCT02822235|Secondary|Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables|Socio-demographic variables included gender and professional status.|Day 1|Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).|||Participants|||Count of Participants
2551068|NCT02822235|Secondary|Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables|Treatment variables included previous treatments or regimens (aminosalicylates, steroids, immunossupressors, biologics, antibiotics); and previous surgeries for IBD. One participant could use more than one treatment regimens.|Day 1|Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).|||Participants|||Count of Participants
2551069|NCT02822235|Secondary|Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables|Clinical variables included IBD type:CD/UC; Family history; Smoking habits; Medical History/Comorbidities; Disease location -L1=ileal, L2=colonic disease, L3=ileocolic, L4=isolated upper GI tract disease location. Behavior as B1/B1+P=Non stenosing/non penetrating or B1+P=Non stenosing/non penetrating+perianal disease, B2/B2+P=Stenosing/B2+P=Stenosing+perianal disease B3/B3+P=Penetrating, B3+P=Penetrating+perianal disease, P=Penetrating disease. Steroid behavior; Colonoscopy, Calprotectin levels >200ug/g.|Day 1|Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).|||Participants|||Count of Participants
2551070|NCT02822235|Secondary|Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables|Socio-demographic variables included gender and professional status.|Day 1|Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).|||Participants|||Count of Participants
2551071|NCT02822235|Secondary|Percentage of Participants With Moderate to Severe CD or UC Who Were Ongoing IBD Treatment at Day 1|Participants with moderate to severe CD or UC ongoing IBD treatment at Day 1 were reported.|Day 1|Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).|||percentage of participants|||Number
2551072|NCT02822235|Secondary|Percentage of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies|IBD types included CD and UC. Biologic therapies included treatment with infliximab, adalimumab, vedolizumab, certolizumab, golimumab and ustekimumab.|Day 1|Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).|||percentage of participants|||Number
2551073|NCT02822235|Secondary|Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years|IBD types included CD and UC. Biologic therapies included treatment with infliximab, adalimumab, vedolizumab, certolizumab, golimumab and ustekimumab. One participant could use more than one biologic therapy.|Within the previous 3 years including Day 1|Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).|||percentage of participants|||Number
2551091|NCT02821962|Other Pre-specified|Changes in Clinical Body Mass Index|Changes in body mass index (kg/m^2)|baseline and 8 weeks|Includes participants with complete data on body mass index from baseline and 8 weeks.|||kilograms per meter squared||Standard Deviation|Mean
2551075|NCT02822235|Secondary|Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables|Clinical variables included IBD type:CD/UC; anthropometric (Height, Weight and BMI); Family history; Smoking habits; Medical History/Comorbidities; Disease location -L1=ileal, L2=colonic disease, L3=ileocolic, L4=isolated upper GI tract disease location. Behavior as B1/B1+P=Non stenosing/non penetrating or B1+P=Non stenosing/non penetrating+perianal disease, B2/B2+P=Stenosing/B2+P=Stenosing+perianal disease B3/B3+P=Penetrating, B3+P=Penetrating+perianal disease, P=Penetrating disease. Extension of inflammation as E1=distal UC: proctitis or E1=distal UC: proctosigmoiditis extension of inflammation E2/E3=left-sided: mucosa inflammation extending up to splenic flexure or E3=pancolitis: mucosa inflammation up to proximal transverse colon and beyond extension of inflammation and severity of UC as S0=Clinical remission, S1=Mild UC, S2=Moderate UC, S3=Severe UC. Steroid behavior; Colonoscopy, Calprotectin levels >200ug/g, Eligibility for 12-month follow-up.|Day 1|Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).|||Participants|||Count of Participants
2551076|NCT02822235|Secondary|Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1||Day 1|Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).|||Participants|||Count of Participants
2551077|NCT02822235|Primary|Number of Participants With Active Ulcerative Colitis (UC) at Day 1|Participants with ≥5 points in Partial Mayo Score were classified as active UC disease. The mayo score without endoscopy measured severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician's global assessment were each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores were then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease).|Day 1|Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment). Participants with UC from cross-sectional population were analyzed for this outcome measure.|||participants|||Number
2551078|NCT02822235|Primary|Percentage of Participants With Active Crohn's Disease (CD) at Day 1|Participants with Harvey Bradshaw Index (HBI) score of ≥8 or Crohn´s Disease Activity Index (CDAI) ≥220 points at Day 1 were classified as participants with active disease. HBI scale assessed five dimensions (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). These dimensions were scored from the previous day. The total score ranges from 0 to 25. The CDAI evaluated the severity of signs and symptoms of CD. Collected data included information on the number of liquid stools, intensity of abdominal pain, general well-being, presence of comorbid conditions, use of medications for diarrhea, physical examination, and laboratory findings (abdominal mass, hematocrit, body weight), yielding 8 items that were combined with data from a 7-day diary to obtain the total CDAI score which ranges from 0 to approximately 600 points, where higher score indicates higher disease activity.|Day 1|Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment). Participants with CD from cross-sectional population were analyzed for this outcome measure.|||percentage of participants|||Number
2551079|NCT02821962|Other Pre-specified|Changes in Depression Symptoms as Measured by the Hospital Anxiety and Depression Scale.|Changes in depression symptom score. Lower scores mean a better outcome. Score ranges from 0 to 21.|baseline and 8 weeks|Includes participants with complete data on depression scores from baseline and 8 weeks.|||score on a scale||Standard Deviation|Mean
2551080|NCT02821962|Other Pre-specified|Changes in HDL|Changes in HDL|baseline and 8 weeks|Includes participants with complete data on HDL from baseline and 8 weeks.|||mmol/L||Standard Deviation|Mean
2551081|NCT02821962|Other Pre-specified|Change in Health-related Quality of Life (Mental Component Scale)|Change in health-related quality of life (Mental Component Scale) from the SF-36. Higher scores represent better mental health. Range 0 to 100.|baseline and 8 weeks|Includes participants with complete data on health-related quality of life from baseline and 8 weeks.|||score on a scale||Standard Deviation|Mean
2551082|NCT02821962|Other Pre-specified|Changes in Maximal Aerobic Power (VO2peak)|Changes in maximal aerobic power as assessed using a Modified Bruce Ramp Treadmill Test|baseline and 8 weeks|Includes participants with complete data on VO2 peak from baseline and 8 weeks.|||mL/kg/min||Standard Deviation|Mean
2551083|NCT02821962|Other Pre-specified|Changes in Pulse Wave Velocity|Changes in pulse wave velocity|baseline and 8 weeks|Includes participants with complete data on pulse wave velocity from baseline and 8 weeks.|||m/s||Standard Deviation|Mean
2551084|NCT02821962|Other Pre-specified|Changes in Health-related Quality of Life (Physical Component Scale)|Changes in health-related quality of life (Physical Component Scale) as measured by the Short Form-36. Higher scores represent better physical health. Range 0 -100|baseline and 8 weeks|Includes participants with complete data on quality of life from baseline and 8 weeks.|||score on a scale||Standard Deviation|Mean
2551085|NCT02821962|Other Pre-specified|Changes in Anxiety|Changes in measures of anxiety as assessed using the Hospital Anxiety and Depression Scale. Lower scores mean a better outcome. Score ranges from 0 to 21.|baseline and 8 weeks|Includes participants with complete data on anxiety from the HADS from baseline and 8 weeks.|||score on a scale||Standard Deviation|Mean
2551086|NCT02821962|Other Pre-specified|Changes in HbA1c Percentage|Changes in HbA1c percentage|baseline and 8 weeks|Includes participants with complete data on HbA1c % from baseline and 8 weeks.|||percentage||Standard Deviation|Mean
2551087|NCT02821962|Other Pre-specified|Changes in Total Cholesterol|Changes in total cholesterol (mmol/L)|baseline and 8 weeks|Includes those with complete data on total cholesterol at baseline and 8 weeks|||mmol/L||Standard Deviation|Mean
2551088|NCT02821962|Other Pre-specified|Changes in Resting Heart Rate|Changes in resting heart rate (bpm)|baseline and 8 weeks|Includes those with complete data on resting heart rate at baseline and 8 weeks|||beats per minute||Standard Deviation|Mean
2551089|NCT02821962|Other Pre-specified|Changes in Systolic Blood Pressure|Changes in systolic blood pressure (mmHg)|baseline and 8 weeks|Includes participants with complete data on systolic blood pressure from baseline and 8 weeks.|||mmHg||Standard Deviation|Mean
2551090|NCT02821962|Other Pre-specified|Changes in Waist Circumference|Changes in waist circumference (cm)|baseline and 8 weeks|Includes participants with complete data on waist circumference from baseline and 8 weeks.|||centimeters||Standard Deviation|Mean
2551093|NCT02821962|Other Pre-specified|Changes in Moderate-to-vigorous Intensity Physical Activity|Changes in moderate-to-vigorous intensity physical activity (measured by activPAL3)|baseline and 8 weeks|Includes participants with complete data on moderate-to-vigorous intensity physical activity from baseline and 8 weeks.|||minutes/day||Standard Deviation|Mean
2551094|NCT02821962|Secondary|Changes in Sedentary Time|Changes in sedentary time measured by the activPAL3 over 8-week intervention period. Reported as proportion of day spent sedentary.|baseline and 8 weeks|Those with complete baseline and post-intervention sedentary time (sitting + lying) measured via activPAL3|||Percentage of day||Standard Deviation|Mean
2551095|NCT02821962|Primary|Feasibility and Usability of activPAL3 and VTAP Devices|"Primary objective is to assess the feasibility and usability of the activPAL3 and VTAP devices in a CR setting. Assessed by examining acceptability of intervention using evaluation surveys (scores). Reporting on number who reported willingness to wear the monitor again (3+). The scale is a 5-point Likert scale that asks On a scale from 1 to 5, would you be willing to wear the monitor again?. Response options include: 1(never), 2, 3 (maybe), 4, and 5 (yes, please)."|9 weeks|Those who completed and returned the satisfaction surveys.|||Participants|||Count of Participants
2551096|NCT02821910|Secondary|Area Under the Concentration-time Curve of the Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)|Area under the concentration-time curve of the Linagliptin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration|PKS|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2551097|NCT02821910|Secondary|Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)|Area under the concentration-time curve of the Metformin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2551098|NCT02821910|Secondary|Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)|Area under the concentration-time curve of the Empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration|PKS|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2551099|NCT02821910|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)|Area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 to 72 hours (AUC0-72) is presented|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration|PKS|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2551100|NCT02821910|Primary|Maximum Measured Concentration of Linagliptin in Plasma (Cmax)|Maximum measured concentration of Linagliptin in plasma (Cmax) is presented|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration|PKS|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2551101|NCT02821910|Primary|Maximum Measured Concentration of Metformin in Plasma (Cmax)|Maximum measured concentration of Metformin in plasma (Cmax) is presented|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2551102|NCT02821910|Primary|Maximum Measured Concentration of Empagliflozin in Plasma (Cmax)|Maximum measured concentration of Empagliflozin in plasma (Cmax) is presented|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration|PKS|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2551103|NCT02821910|Primary|Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)|Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz) is presented|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration|PKS|||nanograms (ng)*h/ milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
2551104|NCT02821910|Primary|Area Under the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)|"Area under the concentration-time curve of Empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz) is presented.~Plasma concentrations and/or parameters of a subject were considered as non-evaluable, if for example~The subject experienced emesis that occurred at or before 2 times median tmax of the respective treatment (median tmax was to be determined excluding the subject's experiencing emesis)~A pre-dose concentration was >5% of the Cmax value measured in that subject~Missing samples or concentration data at important phases of PK disposition curve"|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h,10h, 12h, 24h, 34h, 48h, and 72h after drug administration|Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects in the TS who provided at least 1 primary or secondary PK parameter that was not excluded according to the criterion's for non-evaluable above.|||nanomoles (nmol)*hours (h)/litres (L)||Geometric Coefficient of Variation|Geometric Mean
2551105|NCT02821819|Secondary|Fertilization Rate|Percentage of properly fertilized eggs after microinjection (ICSI) method|24 hours after day of oocyte collection||||Percentage of properly fertilized eggs||Standard Deviation|Median
2551106|NCT02821819|Primary|Percentage of Mature Eggs|When collected, eggs retain numerous cells (granulosa or cumulus cells) surrounding the oocyte; this structure is termed as the cumulus oocyte complex (COC). Few hours later (2-4 hs), the oocyte is denuded from these cumulus cells, allowing for a clearer observation of the maturity status (presence or absence of a metaphase II) of the oocyte. The percentage of mature eggs represents the proportion resulting from dividing the total number of COCs collected by the number of metaphase II oocytes and multiplied by 100.|Up to 24 hours from the oocyte collection||||Percentage of mature eggs||Standard Deviation|Mean
2551107|NCT02821455|Secondary|Correlation Between Bispectral Index (BIS) and End-tidal Isoflurane or Sevoflurane Concentration During One-lung Ventilation.|The significance of the correlation between BIS and end-tidal isoflurane or sevoflurane concentration during one-lung ventilation.|10 minutes after start of one-lung ventilation|Data not collected due to insufficient use of Bispectral Index Monitors and temperature monitors by anaesthetists responsible for the study participants at the study site.||||||
2551108|NCT02821455|Primary|Correlation Between Blood and End-tidal Isoflurane or Sevoflurane Concentration During One-lung Ventilation|The significance of the correlation between blood and end-tidal isoflurane or sevoflurane concentration during one-lung ventilation|10 minutes after start of one-lung ventilation||||Correlation coefficient|||Number
2551109|NCT02821403|Secondary|Self-assessment of Lens Performance Through Questionnaire|"After each monthly wearing period (visits 3-5), the participants' lens performance, night vision quality and sleep quality (total 13 questions) were assessed subjectively using a questionnaire (scoring from 1 [very unsatisfactory] to 5 [very satisfactory]).~At the end of the study, the participants were asked to choose their preferred lens type among the three pairs of lenses based on their subjective feeling of the best lens type (i.e., either clear lens, yellow tinted lens or blue-filtering coated lens).~To make it clear and simple, here we only present the data on the participants choice of their preferred lens type (i.e., simply choosing the best lens among clear lens, yellow tinted lens or blue-filtering coated lens)."|Every 1-month interval from the date of randomization, up to 3 months||||Participants|||Count of Participants
2551110|NCT02821403|Primary|Color Vision as Assessed by the Farnsworth Munsell 100 Hue Test|"The Farnsworth Munsell 100 hue test (X-Rite, USA) was used to evaluate colour vision. Each of the four trays consisted of 21 movable caps. Participants were asked to sort the randomly arranged caps following the hue order from the first to the last fixed caps. The total error score was calculated, as documented in the instruction manual, to quantify the accuracy of color discrimination.~There are no defined endpoints to the total error score range.~A lower score indicates improved color discrimination ability."|Every 1-month interval from the date of randomization, up to 3 months||||units on a scale||Standard Error|Mean
2551111|NCT02821403|Primary|Contrast Sensitivity as Assessed by Mars Contrast Sensitivity Chart|"Contrast sensitivity was measured using the Mars contrast sensitivity letter chart (Mars Perceptrix, Chappaqua, NY). One out of three charts differing in the letter combinations was selected randomly in order to avoid memorization of the charts. The chart was placed at 50 cm with each letter subtended 2° visual angle. We followed the recording procedures as specified by the manufacturer: participants were instructed to read the letters from high to low contrasts and the test ended when two consecutive errors were made. The contrast sensitivity was scored as the log contrast sensitivity of the last correct letter minus 0.04 log unit for every prior error. The test was administered under normal (room illumination, 400 lux) and glare conditions. A brightness acuity tester set at its medium light intensity level (100 foot lamberts) simulated the glaring condition.~A higher mean indicates improved contrast sensitivity."|Every 1-month interval from the date of randomization, up to 3 months||||log contrast sensitivity score||Standard Error|Mean
2551112|NCT02821000|Secondary|Observed Serum Concentration of Pembrolizumab 14 Days After The End of Infusion During Cycle 1 (21-day Cycle)|Blood samples were obtained for PK analysis of the serum concentration of pembrolizumab 14 days after the end of infusion during Cycle 1 (21-day cycle). The serum concentration of pembrolizumab is presented. These PK results are based on a 20-Jul-2017 data cutoff date.|Day 15: 14 days after the end of infusion during Cycle 1 (21-day cycle)|The analysis population consisted of participants who received 1 dose of study treatment in Cycle 1 (21-day cycle) and had blood samples drawn for serum concentration of pembrolizumab.|||μg/mL||Standard Deviation|Mean
2551113|NCT02821000|Secondary|Observed Serum Concentration of Pembrolizumab 5 Days After The End of Infusion During Cycle 1 (21-day Cycle)|Blood samples were obtained for PK analysis of the serum concentration of pembrolizumab 5 days after the end of infusion during Cycle 1 (21-day cycle). The serum concentration of pembrolizumab is presented. These PK results are based on a 20-Jul-2017 data cutoff date.|Day 6: 5 days after the end of infusion during Cycle 1 (21-day cycle)|The analysis population consisted of participants who received 1 dose of study treatment in Cycle 1 (21-day cycle) and had blood samples drawn for serum concentration of pembrolizumab.|||μg/mL||Standard Deviation|Mean
2551114|NCT02821000|Secondary|Observed Serum Concentration of Pembrolizumab 1 Day After The End of Infusion During Cycle 1 (21-day Cycle)|Blood samples were obtained for PK analysis of the serum concentration of pembrolizumab 1 day after the end of infusion during Cycle 1 (21-day cycle). The serum concentration of pembrolizumab is presented. These PK results are based on a 20-Jul-2017 data cutoff date.|Day 2: 1 day after the end of infusion during Cycle 1 (21-day cycle)|The analysis population consisted of participants who received 1 dose of study treatment in Cycle 1 (21-day cycle) and had blood samples drawn for serum concentration of pembrolizumab.|||μg/mL||Standard Deviation|Mean
2551115|NCT02821000|Secondary|Observed Maximum Serum Concentration (Cmax) of Pembrolizumab 30 Minutes After The End of Infusion During Cycle 8 (21-day Cycle)|Blood samples were obtained for PK analysis of the Cmax of pembrolizumab 30 minutes after the end of infusion during Cycle 8 (21-day cycle). The Cmax of pembrolizumab is presented. These PK results are based on a 20-Jul-2017 data cutoff date.|Day 147: 30 minutes after the end of infusion during Cycle 8 (21-day cycle)|The analysis population consisted of participants who received 8 doses of study treatment and had blood samples drawn for Cmax analysis.|||μg/mL||Standard Deviation|Mean
2551116|NCT02821000|Secondary|Observed Maximum Serum Concentration (Cmax) of Pembrolizumab 30 Minutes After The End of Infusion During Cycle 1 (21-day Cycle)|Blood samples were obtained for PK analysis of the Cmax of pembrolizumab 30 minutes after the end of infusion during Cycle 1 (21-day cycle). The Cmax of pembrolizumab is presented. These PK results are based on a 20-Jul-2017 data cutoff date.|Day 0: 30 minutes after the end of infusion during Cycle 1 (21-day cycle)|The analysis population consisted of participants who received 1 dose of study treatment in Cycle 1 (21-day cycle) and had blood samples drawn for Cmax analysis.|||μg/mL||Standard Deviation|Mean
2551146|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 100 U/GSK1358820 100 U|Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.|Up to 48 weeks after 1st treatment|Safety Population 2.|||Participants|||Count of Participants
2551117|NCT02821000|Secondary|Trough Serum Concentration (Ctrough) of Pembrolizumab Prior to Cycle 16 (21-day Cycle)|Blood samples were obtained for PK analysis of the lowest (trough) concentration of pembrolizumab prior to the next dose of pembrolizumab administered during Cycle 16 (21-day cycle). The mean Ctrough of pembrolizumab prior to Cycle 16 is presented. These PK results are based on a 20-Jul-2017 data cutoff date.|Day 315: Prior to the Cycle 16 (21-day cycle) Dose|The analysis population consisted of participants who received 15 doses of study treatment, completed Cycle 15 (21-day cycle), and had blood samples drawn for Ctrough analysis.|||μg/mL||Standard Deviation|Mean
2551118|NCT02821000|Secondary|Trough Serum Concentration (Ctrough) of Pembrolizumab Prior to Cycle 12 (21-day Cycle)|Blood samples were obtained for PK analysis of the lowest (trough) concentration of pembrolizumab prior to the next dose of pembrolizumab administered during Cycle 12 (21-day cycle). The mean Ctrough of pembrolizumab prior to Cycle 12 is presented. These PK results are based on a 20-Jul-2017 data cutoff date.|Day 231: Prior to the Cycle 12 (21-day cycle) Dose|The analysis population consisted of participants who received 11 doses of study treatment, completed Cycle 11 (21-day cycle), and had blood samples drawn for Ctrough analysis.|||μg/mL||Standard Deviation|Mean
2551119|NCT02821000|Secondary|Trough Serum Concentration (Ctrough) of Pembrolizumab Prior to Cycle 8 (21-day Cycle)|Blood samples were obtained for PK analysis of the lowest (trough) concentration of pembrolizumab prior to the next dose of pembrolizumab administered during Cycle 8 (21-day cycle). The mean Ctrough of pembrolizumab prior to Cycle 8 is presented. These PK results are based on a 20-Jul-2017 data cutoff date.|Day 147: Prior to the Cycle 8 (21-day cycle) Dose|The analysis population consisted of participants who received 7 doses of study treatment, completed Cycle 7 (21-day cycle), and had blood samples drawn for Ctrough analysis.|||μg/mL||Standard Deviation|Mean
2551120|NCT02821000|Secondary|Trough Serum Concentration (Ctrough) of Pembrolizumab Prior to Cycle 6 (21-day Cycle)|Blood samples were obtained for PK analysis of the lowest (trough) concentration of pembrolizumab prior to the next dose of pembrolizumab administered during Cycle 6 (21-day cycle). The mean Ctrough of pembrolizumab prior to Cycle 6 is presented. These PK results are based on a 20-Jul-2017 data cutoff date.|Day 105: Prior to the Cycle 6 (21-day cycle) Dose|The analysis population consisted of participants who received 5 doses of study treatment, completed Cycle 5 (21-day cycle), and had blood samples drawn for Ctrough analysis.|||μg/mL||Standard Deviation|Mean
2551121|NCT02821000|Secondary|Trough Serum Concentration (Ctrough) of Pembrolizumab Prior to Cycle 4 (21-day Cycle)|Blood samples were obtained for PK analysis of the lowest (trough) concentration of pembrolizumab prior to the next dose of pembrolizumab administered during Cycle 4 (21-day cycle). The mean Ctrough of pembrolizumab prior to Cycle 4 is presented. These PK results are based on a 20-Jul-2017 data cutoff date.|Day 63: Prior to the Cycle 4 (21-day cycle) Dose|The analysis population consisted of participants who received 3 doses of study treatment, completed Cycle 3 (21-day cycle), and had blood samples drawn for Ctrough analysis.|||μg/mL||Standard Deviation|Mean
2551122|NCT02821000|Secondary|Trough Serum Concentration (Ctrough) of Pembrolizumab Prior to Cycle 2 (21-day Cycle)|Blood samples were obtained for PK analysis of the lowest (trough) concentration of pembrolizumab prior to the next dose of pembrolizumab administered during Cycle 2 (21-day cycle). The mean Ctrough of pembrolizumab prior to Cycle 2 is presented. These PK results are based on a 20-Jul-2017 data cutoff date.|Day 21: Prior to the Cycle 2 (21-day cycle) Dose|The analysis population consisted of participants who received 1 dose of study treatment, completed Cycle 1 (21-day cycle), and had blood samples drawn for Ctrough analysis.|||μg/mL||Standard Deviation|Mean
2551123|NCT02821000|Secondary|Duration of Response (DOR) by Immune-related Response Evaluation Criteria in Solid Tumors Version (irRECIST)|DOR was defined as the time from first documented evidence of Complete Response (CR: disappearance of all lesions and no new lesions confirmed by a consecutive assessment at least 4 weeks after first documentation) or Partial Response (PR: at least a 50% decrease in tumor burden relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation) per irRECIST until disease progression or death due to any cause, whichever occurred first. Using irRECIST, progressive disease was defined as at least a 25% increase in tumor burden relative the minimum recorded tumor burden confirmed by a consecutive assessment at least 4 weeks after first documentation. DOR assessments were based on blinded independent central review (BICR). DOR was analyzed using the Kaplan-Meier method and is reported in months. DOR for participants who experienced a confirmed CR or PR is presented. These efficacy results are based on a 27-Dec-2017 data cutoff date.|Up to approximately 24 months|The analysis population consisted of all participants who received at least one dose of study treatment, had measurable disease at baseline, and had confirmed CR or PR.|||Months||Full Range|Median
2551124|NCT02821000|Secondary|Progression-free Survival (PFS) Per Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)|PFS was defined as the time from the first day of study treatment to the first documented disease progression per irRECIST based on blinded independent central review (BICR) or death due to any cause, whichever occurred first. Using irRECIST, progressive disease was defined as at least a 25% increase in tumor burden relative the minimum recorded tumor burden confirmed by a consecutive assessment at least 4 weeks after first documentation. PFS was analyzed using the Kaplan-Meier method and is reported in months. The PFS per irRECIST for participants is presented. These efficacy results are based on a 27-Dec-2017 data cutoff date.|Up to approximately 24 months|The analysis population consisted of all participants who received at least one dose of study treatment and had measurable disease at baseline.|||Months||95% Confidence Interval|Median
2551125|NCT02821000|Secondary|Objective Response Rate (ORR) Per Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)|ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: disappearance of all lesions and no new lesions confirmed by a consecutive assessment at least 4 weeks after first documentation) or a Partial Response (PR: at least a 50% decrease in tumor burden relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation) per irRECIST assessed by blinded independent central review (BICR). The ORR per irRECIST for participants is presented. Participants without response data were treated as non-responders. ORR was analyzed using an exact method based on binomial distribution (Clopper-Pearson method) and is reported as percentage of participants. These efficacy results are based on a 27-Dec-2017 data cutoff date.|Up to approximately 24 months|The analysis population consisted of all participants who received at least one dose of study treatment and had measurable disease at baseline.|||Percentage of Participants||95% Confidence Interval|Number
2551126|NCT02821000|Secondary|Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|DOR was defined as the time from first documented evidence of Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until disease progression or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must have demonstrated an absolute increase of at least 5 mm. DOR assessments were based on blinded independent central review (BICR). DOR was analyzed using the Kaplan-Meier method and is reported in months. DOR for participants who experienced a confirmed CR or PR is presented. These efficacy results are based on a 27-Dec-2017 data cutoff date.|Up to approximately 24 months|The analysis population consisted of all participants who received at least one dose of study treatment, had measurable disease at baseline, and had confirmed CR or PR.|||Months||Full Range|Median
2551127|NCT02821000|Secondary|Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central review (BICR) or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. PFS was analyzed using the Kaplan-Meier method and is reported in months. The PFS per RECIST 1.1 for participants is presented. These efficacy results are based on a 27-Dec-2017 data cutoff date.|Up to approximately 24 months|The analysis population consisted of all participants who received at least one dose of study treatment and had measurable disease at baseline.|||Months||95% Confidence Interval|Median
2551128|NCT02821000|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. OS was analyzed using the Kaplan-Meier method and is reported in months. The OS for participants is presented. These efficacy results are based on a 27-Dec-2017 data cutoff date.|Up to approximately 24 months|The analysis population consisted of all participants who received at least one dose of study treatment.|||Months||95% Confidence Interval|Median
2551129|NCT02821000|Primary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 assessed by blinded independent central review (BICR). The ORR per RECIST 1.1 for participants is presented. Participants without response data were treated as non-responders. ORR was analyzed using an exact method based on binomial distribution (Clopper-Pearson method) and is reported as percentage of participants. These efficacy results are based on a 27- Dec-2017 data cutoff date.|Up to approximately 24 months|The analysis population consisted of all participants who received at least one dose of study treatment and had measurable disease at baseline.|||Percentage of Participants||95% Confidence Interval|Number
2551130|NCT02821000|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|The number of all participants who discontinued study treatment due to an AE is presented. These results are based on a 27- Dec-2017 data cutoff date.|Up to approximately 24 months|The safety population consisted of all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2551131|NCT02821000|Primary|Number of Participants Who Experienced At Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of all participants who experienced at least one AE is presented. These safety results are based on a 27- Dec-2017 data cutoff date.|Up to approximately 27 months|The safety population consisted of all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2551132|NCT02820870|Secondary|Responses on Provider Response Forms|As a fidelity evaluation, the investigators will assess the reasons providers give for making or not making a clinical change during an intervention visit. We provided forms with check boxes for each of the outcomes listed.|3 months|Data represents the responses on the forms returned. The survey asked respondents if they made changes to their statins and to provide reasoning behind their decisions. Some selected more than one answer and some returned the survey that denoted yes/no but did not answer follow-up question elaborating on their decision.|||Response forms|Response forms||Count of Units
2551133|NCT02820870|Secondary|Percent of Provider Response Forms Returned|As a fidelity evaluation, the investigators will assess the rates at which providers return the provider response forms, which are given to understand why intervention providers did or did not alter care.|3 months|Whenever an intervention arm provider received a decision support reminder, they were also given a provider response form.|||Response forms|Response forms||Count of Units
2551134|NCT02820870|Secondary|Percent of Visits in the Post-intervention 3 Months Where Moderate-to-high Strength Statins Are Appropriately Initiated|To test the continued impact of the intervention, after the intervention was complete and both arms were receiving usual care we measured if a statin was started in the 30 days from the time of the visit among patients who are recommended moderate-to-high strength statins by the VA/DoD clinical practice guidelines, but were not on them at the time of their visit. This secondary outcome looks at the stability of the results after the intervention was stopped, not during the intervention. It is a different set of visits and has a different set of numbers from the intervention. During this period both groups received usual care.|3 months|Patient visits in the 3 months following the intervention with the same inclusion criteria used for the intervention. The analysis was based on visits, not patients. It is possible that patients were included in more than one visit, as long as they were still guideline discordant.|||Visits|Visits||Count of Units
2551135|NCT02820870|Primary|Percent of Visits Where Moderate-to-high-strength Statins Are Appropriately Initiated|For a given visit during the study period for a patient who is guideline-appropriate for a moderate-to-high-strength statin but is not on one, the primary outcome is met if that patient is started on a moderate-or-high-strength statin within 30 days from the time of the visit, according to EHR medication data. The analysis was based on visits, not patients. It is possible that patients were included in more than one visit, as long as they were still guideline discordant.|30 days|Five care teams were randomized. Two with 15 total providers received the intervention. Three, with 28 providers, were the control arm. During the QI period, the intervention arm had 573 eligible visits and the control arm had 673. Our outcome was the chance an appropriate statin would be started at a visit.|||Visits|Visits||Count of Units
2551136|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal ECG Findings|Single 12-lead ECGs were obtained at indicated time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS and QT interval. QTc value is machine-read or manually over-read. CS and NCS abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.|Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3|Safety Population 1. All the participants in this population were analyzed (108, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2551137|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal ECG Findings|Single 12-lead ECGs were obtained at indicated time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS and QT interval. QTc value is machine-read or manually over-read. CS and NCS abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.|Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2|Safety Population 1. All the participants in this population were analyzed (108, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2551138|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Single 12-lead ECGs were obtained at indicated time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS and QT interval. QT interval corrected for heart rate (QTc) value is machine-read or manually over-read. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Clinically significant (CS) and not clinically significant (NCS) abnormal ECG findings have been presented. CS abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.|Baseline (Pre-dose on Day 1), Week 12 and Week 48 in Treatment Cycle 1|SPDB Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.|||Participants|||Count of Participants
2551139|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: GSK1358820 100 U/GSK1358820 100 U|The kidney and bladder ultrasound was performed in order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants with abnormal findings after kidney and bladder ultrasound have been presented.|Up to 48 weeks after 1st treatment|Safety Population 3.|||Participants|||Count of Participants
2551140|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: Placebo/GSK1358820 100 U|The kidney and bladder ultrasound was performed in order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants with abnormal findings after kidney and bladder ultrasound have been presented.|Up to 48 weeks after 1st treatment|Safety Population 2.|||Participants|||Count of Participants
2551141|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: GSK1358820 100 U/GSK1358820 100 U|The kidney and bladder ultrasound was performed in order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants with abnormal findings after kidney and bladder ultrasound have been presented.|Up to 48 weeks after 1st treatment|Safety Population 2.|||Participants|||Count of Participants
2551142|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound: Placebo/GSK1358820 100 U|The kidney and bladder ultrasound was performed in order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants with abnormal findings after kidney and bladder ultrasound have been presented.|Up to 48 weeks after 1st treatment|Safety Population 1.|||Participants|||Count of Participants
2551143|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Abnormal Findings Undergoing Kidney and Bladder Ultrasound|The kidney and bladder ultrasound was performed in order to assess the presence of stones in the kidneys and bladder, an ultrasound of these structures (with the bladder at least half full) was performed. Participants with abnormal findings after kidney and bladder ultrasound have been presented.|Up to 48 weeks in Treatment Cycle 1|SPDB Population.|||Participants|||Count of Participants
2551144|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: GSK1358820 100 U/GSK1358820 100 U|Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.|Up to 48 weeks after 1st treatment|Safety Population 3.|||Participants|||Count of Participants
2551145|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo/GSK1358820 100 U|Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.|Up to 48 weeks after 1st treatment|Safety Population 2.|||Participants|||Count of Participants
2551147|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants Using CIC for Urinary Retention or Elevated PVR: Placebo/GSK1358820 100 U|Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.|Up to 48 weeks after 1st treatment|Safety Population 1.|||Participants|||Count of Participants
2551148|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Number of Participants Using Clean Intermittent Catheterization (CIC) for Urinary Retention or Elevated PVR|Participants who had used CIC at least once after the first treatment with the reason for urinary retention or elevated PVR have been presented.|Up to 48 weeks in Treatment Cycle 1|SPDB Population.|||Participants|||Count of Participants
2551149|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U|PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3|Safety Population 1. All the participants in this population were analyzed (124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Milliliter||Standard Deviation|Mean
2551150|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U|PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3|Safety Population 1. All the participants in this population were analyzed (108 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Milliliter||Standard Deviation|Mean
2551151|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: GSK1358820 100 U/GSK1358820 100 U|PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2|Safety Population 1. All the participants in this population were analyzed (124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Milliliter||Standard Deviation|Mean
2551152|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in PVR Urine Volume: Placebo/GSK1358820 100 U|PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2|Safety Population 1. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.|||Milliliter||Standard Deviation|Mean
2551153|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in PVR Urine Volume|PVR urine volume was assessed by ultrasound or bladder scan after participants perform a voluntary void according to the study schedule. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1|SPDB Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Milliliter||Standard Deviation|Mean
2551154|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: GSK1358820 100 U/GSK1358820 100 U|A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with >=10^5 CFU/mL and leukocyturia with >5 per high power field was noted.|Up to 48 weeks after 1st treatment|Safety Population 3.|||Participants|||Count of Participants
2551155|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With UTI: Placebo/GSK1358820 100 U|A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with >=10^5 CFU/mL and leukocyturia with >5 per high power field was noted.|Up to 48 weeks after 1st treatment|Safety Population 2.|||Participants|||Count of Participants
2551156|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: GSK1358820 100 U/GSK1358820 100 U|A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with >=10^5 CFU/mL and leukocyturia with >5 per high power field was noted.|Up to 48 weeks after 1st treatment|Safety Population 2.|||Participants|||Count of Participants
2551157|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With UTI: Placebo/GSK1358820 100 U|A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with >=10^5 CFU/mL and leukocyturia with >5 per high power field was noted.|Up to 48 weeks after 1st treatment|Safety Population 1.|||Participants|||Count of Participants
2551158|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Urinary Tract Infection (UTI)|A urine culture and sensitivity test were performed when urinalysis results with a urine reagent strip are suggestive of a UTI (positive nitrites or leukocyte esterase). UTI was recorded as an AE, irrespective of symptoms when the result of urine culture was positive (with the presence of bacteriuria with >=10^5 Colony Forming Unit per milliliter (CFU/mL) and leukocyturia with >5 per high power field was noted.|Up to 48 weeks in Treatment Cycle 1|SPDB Population.|||Participants|||Count of Participants
2551159|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline|Urine samples were collected for analysis of presence of occult blood and protein in urine using dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of occult blood and protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Pre-dose of Treatment Cycle 1) and up to 48 weeks after 1st treatment|Safety Population 1. All the participants in this population were analyzed (108, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2551160|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline|Urine samples were collected for analysis of presence of occult blood and protein in urine using dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of occult blood and protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Pre-dose of Treatment Cycle 1) and up to 48 weeks after 1st treatment|Safety Population 1. All the participants in this population were analyzed (108, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2551161|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Worst Case Post-Baseline Urinalysis Results Relative to Baseline|Urine samples were collected for analysis of presence of occult blood and protein in urine using dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of occult blood and protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Pre-dose on Day 1) and up to 48 weeks in Treatment Cycle 1|SPDB Population.|||Participants|||Count of Participants
2551162|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters|Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosino, Hb, Hct, Lympho, Monocytes, N bands, T neutro, PC, RBC count, and WBC. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3|Safety Population 1. All the participants in this population were analyzed (108, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2551163|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters|Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosino, Hb, Hct, Lympho, Monocytes, N bands, T neutro, PC, RBC count, and WBC. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2|Safety Population 1. All the participants in this population were analyzed (108, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2551164|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Hematology Parameters|Blood samples were collected from participants for analysis of following hematology parameters; Basophils, Eosinophils (Eosino), Hemoglobin (Hb), Hematocrit (Hct), Lymphocytes (Lympho), Monocytes, Neutrophil Bands (N bands), Total Neutrophils (T neutro), Platelet count (PC), Red Blood Cell (RBC) count, and White Blood Cell count (WBC). Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, were recorded in the 'To Normal or No Change' category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Pre-dose on Day 1), Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1|SPDB Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2551306|NCT02819804|Secondary|Incidence of Adverse Events|To evaluate the toxicity and safety of nivolumab and dasatinib in patients with relapsed/refractory Ph+ ALL. Adverse events will be assessed by number, frequency, and severity and will be graded according to the NCI's common terminology criteria, version 4.03.|Up to 28-days after the last dose|||||||
2551165|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results|Blood samples were collected for analysis of following clinical chemistry parameters; Albumin, Alk Phosp, ALT, AST, Direct Bil, Total Bil, Calcium, Chloride, Creatinine, Glucose, Potassium, Sodium, T Protein, Urea/BUN and Uric acid. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3|Safety Population 1. All the participants in this population were analyzed (108, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2551166|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results|Blood samples were collected for analysis of following clinical chemistry parameters; Albumin, Alk Phosp, ALT, AST, Direct Bil, Total Bil, Calcium, Chloride, Creatinine, Glucose, Potassium, Sodium, T Protein, Urea/BUN and Uric acid. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Pre-dose of Treatment Cycle 1), Week 12 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2|Safety Population 1. All the participants in this population were analyzed (108, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2551167|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Shift From Baseline Relative to Normal Range in Chemistry Results|Blood samples were collected for analysis of following clinical chemistry parameters; Albumin, Alkaline Phosphatase (Alk Phosp), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Direct Bilirubin (Bil), Total Bil, Calcium, Chloride, Creatinine, Glucose, Potassium, Sodium, Total Protein (T Protein), Urea/blood urea nitrogen (BUN) and Uric acid. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g. High to High) or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100 percent. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.|Baseline (Pre-dose on Day 1), Week 12 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1|SPDB Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2551168|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U|Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3|Safety Population 1. All the participants in this population were analyzed (124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Degree Celsius||Standard Deviation|Mean
2551169|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U|Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3|Safety Population 1. All the participants in this population were analyzed (108 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Degree Celsius||Standard Deviation|Mean
2551170|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: GSK1358820 100 U/GSK1358820 100 U|Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2|Safety Population 1. All the participants in this population were analyzed (124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Degree Celsius||Standard Deviation|Mean
2551171|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Temperature: Placebo/GSK1358820 100 U|Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2|Safety Population 1. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.|||Degree Celsius||Standard Deviation|Mean
2551172|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Temperature|Temperature was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1|SPDB Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.|||Degree Celsius||Standard Deviation|Mean
2551173|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U|Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3|Safety Population 1. All the participants in this population were analyzed (124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Beats per minute||Standard Deviation|Mean
2551174|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U|Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3|Safety Population 1. All the participants in this population were analyzed (108 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Beats per minute||Standard Deviation|Mean
2551175|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: GSK1358820 100 U/GSK1358820 100 U|Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2|Safety Population 1. All the participants in this population were analyzed (124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Beats per minute||Standard Deviation|Mean
2551176|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in Heart Rate: Placebo/GSK1358820 100 U|Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 Week 30, Week 36 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2|Safety Population 1. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.|||Beats per minute||Standard Deviation|Mean
2551177|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Heart Rate|Heart rate was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose on Day 1) and Week 2, Week 6, Week 12, Week 18, Week 24 Week 30, Week 36, Week 42 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1|SPDB Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.|||Beats per minute||Standard Deviation|Mean
2551178|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U|Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3|Safety Population 1. All the participants in this population were analyzed (124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Millimeter of mercury||Standard Deviation|Mean
2551179|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U|Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 3|Safety Population 1. All the participants in this population were analyzed (108 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Millimeter of mercury||Standard Deviation|Mean
2551180|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: GSK1358820 100 U/GSK1358820 100 U|Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2|Safety Population 1. All the participants in this population were analyzed (124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Millimeter of mercury||Standard Deviation|Mean
2551181|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Change From Baseline in SBP and DBP: Placebo/GSK1358820 100 U|Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36 and Week 48 (48 weeks after 1st treatment or withdrawal visit) in Treatment Cycle 2|Safety Population 1. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.|||Millimeter of mercury||Standard Deviation|Mean
2551182|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure was measured in seated position after 5 minutes rest for participants at indicated time points. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 (study exit or withdrawal visit) in Treatment Cycle 1|SPDB Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.|||Millimeter of mercury||Standard Deviation|Mean
2551183|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: GSK1358820 100 U/GSK1358820 100 U|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment. Safety Population 3 comprised of all participants who received at least three doses of GSK1358820.|Up to 48 weeks after 1st treatment|Safety Population 3.|||Participants|||Count of Participants
2551184|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 100 U|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment.|Up to 48 weeks after 1st treatment|Safety Population 2.|||Participants|||Count of Participants
2551185|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: GSK1358820 100 U/GSK1358820 100 U|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment. Safety Population 2 comprised of all participants who received at least two doses of GSK1358820.|Up to 48 weeks after 1st treatment|Safety Population 2.|||Participants|||Count of Participants
2551186|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2)- Number of Participants With SAEs and Non-SAEs: Placebo/GSK1358820 100 U|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment. Safety Population 1 comprised of all participants who received at least one dose of GSK1358820.|Up to 48 weeks after 1st treatment|Safety Population 1.|||Participants|||Count of Participants
2551187|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or other situations as per medical or scientific judgment.|Up to 48 weeks in Treatment Cycle 1|Safety for double blind phase (SPDB) Population comprised of all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2551188|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in OABSS Total Score|Symptoms of frequency, nocturia, urinary urgency, and urge incontinence were assessed. OABSS questionnaire consisted of 4 questions: number of times participants urinate from waking in the morning until sleeping at night, ranging from 0 (<=7 times) to 1 (>=15 times); number of times participants wake up to urinate from sleeping at night until waking in the morning, ranging from 0 (0 times) to 3 (>=3 times); number of times for sudden desire to urinate, ranging from 0 (Not at all) to 5 (5 times a day or more); number of times of urine leakage, ranging from 0 (Not at all) to 5 (5 times a day or more). OABSS total score was calculated as the sum of scores for above 4 questions. The range of total score of OABSS was 0 to 15 with higher score indicating, more severity of symptoms. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 12 and Week 24 in Treatment Cycle 3|FAS3 Population. All the participants in this population were analyzed (56, 43 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Scores on a scale||Standard Deviation|Mean
2551189|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in OABSS Total Score|Symptoms of frequency, nocturia, urinary urgency, and urge incontinence were assessed. OABSS questionnaire consisted of 4 questions: number of times participants urinate from waking in the morning until sleeping at night, ranging from 0 (<=7 times) to 1 (>=15 times); number of times participants wake up to urinate from sleeping at night until waking in the morning, ranging from 0 (0 times) to 3 (>=3 times); number of times for sudden desire to urinate, ranging from 0 (Not at all) to 5 (5 times a day or more); number of times of urine leakage, ranging from 0 (Not at all) to 5 (5 times a day or more). OABSS total score was calculated as the sum of scores for above 4 questions. The range of total score of OABSS was 0 to 15 with higher score indicating, more severity of symptoms. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 12, Week 24 and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Scores on a scale||Standard Deviation|Mean
2551190|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score|Symptoms of frequency, nocturia, urinary urgency, and urge incontinence were assessed. OABSS questionnaire consisted of 4 questions: number of times participants urinate from waking in the morning until sleeping at night, ranging from 0 (<=7 times) to 1 (>=15 times); number of times participants wake up to urinate from sleeping at night until waking in the morning, ranging from 0 (0 times) to 3 (>=3 times); number of times for sudden desire to urinate, ranging from 0 (Not at all) to 5 (5 times a day or more); number of times of urine leakage, ranging from 0 (Not at all) to 5 (5 times a day or more). OABSS total score was calculated as the sum of scores for above 4 questions. The range of total score of OABSS was 0 to 15 with higher score indicating, more severity of symptoms. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose on Day 1), Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1|FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Scores on a scale||Standard Deviation|Mean
2551191|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants With Positive Response on the TBS|Treatment benefit of GSK1358820 was assessed with TBS ranging from 1(Greatly improved) to 4 (Worsened). This questionnaire consists of 4 answers to 1 question by considering current condition of participants (urinary problems, urinary incontinence) compared to condition before participants received any study treatment in this trial. Positive treatment response was defined as score of either 1 or 2 (representing 'greatly improved' or 'improved').|Week 0, Week 2, Week 6, Week 12 and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percentage of participants|||Number
2551192|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants With Positive Response on the TBS|Treatment benefit of GSK1358820 was assessed with TBS ranging from 1(Greatly improved) to 4 (Worsened). This questionnaire consists of 4 answers to 1 question by considering current condition of participants (urinary problems, urinary incontinence) compared to condition before participants received any study treatment in this trial. Positive treatment response was defined as score of either 1 or 2 (representing 'greatly improved' or 'improved').|Week 0, Week 2, Week 6, Week 12, Week 24 and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percentage of participants|||Number
2551193|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants With Positive Response on the Treatment Benefit Scale (TBS)|Treatment benefit of GSK1358820 was assessed with TBS ranging from 1(Greatly improved) to 4 (Worsened). This questionnaire consists of 4 answers to 1 question by considering current condition of participants (urinary problems, urinary incontinence) compared to condition before participants received any study treatment in this trial. Positive treatment response was defined as score of either 1 or 2 (representing 'greatly improved' or 'improved').|Week 2, Week 6, Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1|FAS1 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percentage of participants|||Number
2551194|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in KHQ Domain Scores|KHQ is a 21 item questionnaire, consisting of 9 domains: GH (1[Very good] to 5[Very poor]), Int Imp (1[Not at all] to 4[A lot]), RL (1[Not at all] to 4[A lot]), PL (1[Not at all] to 4[A lot]), SL (0[not applicable] to 4[A lot]), PR (0[Not applicable] to 4[A lot]), Emotions (1[Not at all] to 4[Very much]), S/ E (1[Never] to 4[All the time]) and S/ C (1[Never] to 4[All the time]). Domain score for GH was calculated as score of one item minus 1/4x100; Int Imp: score of one item minus 1/3x100; RL, PL, PR, S/ E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S/ C: summed scores of 5 items minus 5/15x100. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 12 and Week 24 in Treatment Cycle 3|FAS3 Population. All the participants in this population were analyzed (56, 43 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Scores on a scale||Standard Deviation|Mean
2551202|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes|"Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated using formula; number of Yes response to the diary question of Did you have accidental urinary leakage? divided by number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day."|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percentage of participants|||Number
2551195|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in KHQ Domain Scores|KHQ is a 21 item questionnaire, consisting of 9 domains: GH (1[Very good] to 5[Very poor]), Int Imp (1[Not at all] to 4[A lot]), RL (1[Not at all] to 4[A lot]), PL (1[Not at all] to 4[A lot]), SL (0[not applicable] to 4[A lot]), PR (0[Not applicable] to 4[A lot]), Emotions (1[Not at all] to 4[Very much]), S/ E (1[Never] to 4[All the time]) and S/ C (1[Never] to 4[All the time]). Domain score for GH was calculated as score of one item minus 1/4x100; Int Imp: score of one item minus 1/3x100; RL, PL, PR, S/ E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S/ C: summed scores of 5 items minus 5/15x100. Baseline is the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 12, Week 24 and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Scores on a scale||Standard Deviation|Mean
2551196|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores|KHQ is a 21 item questionnaire, consisting of 9 domains: General health (GH) (1[Very good] to 5[Very poor]), Incontinence impact (Int Imp) (1[Not at all] to 4[A lot]), Role Limitations (RL) (1[Not at all] to 4[A lot]), Physical limitations (PL) (1[Not at all] to 4[A lot]), Social limitations (SL) (0[not applicable] to 4[A lot]), Personal relationships (PR) (0[Not applicable] to 4[A lot]), Emotions (1[Not at all] to 4[Very much]), Sleep/ energy (S/ E) (1[Never] to 4[All the time]) and Severity/Coping (S/ C) (1[Never] to 4[All the time]). Domain score for GH was calculated as score of one item minus 1/4x100; Int Imp: score of one item minus 1/3x100; RL, PL, PR, S/ E: summed scores of 2 items minus 2/6x100; SL, Emotions: summed scores of 3 items minus 3/9x100; S/ C: summed scores of 5 items minus 5/15x100. Baseline is the latest pre-dose assessment with a non-missing value,including those from unscheduled visits. Change from Baseline was any visit value minus Baseline value.|Baseline (Pre-dose on Day 1), Week 12, Week 24, Week 36 and Week 48 in Treatment Cycle 1|FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Scores on a scale||Standard Deviation|Mean
2551197|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Time to Request for Retreatment|The time taken by the participants to request re-treatment was reported. Time to the participant's first request for 2nd treatment from the day of 1st treatment was calculated as the earliest date when participants requested retreatment minus the day of first treatment plus 1.|Up to 36 weeks in Treatment Cycle 1|FAS1 Population.|||Days||95% Confidence Interval|Median
2551198|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Time to Qualification for Retreatment|Participants were considered for re-treatment beginning at the Week 12 visit following the initial treatment or the Week 12 visit following any re-treatment. Qualification criteria was; participants must have initiated request for re-treatment, participants experienced >=2 episodes of urinary urgency incontinence, with no more than one urgency incontinence-free day, post-void residual (PVR) urine volume must have been <200 milliliter; investigator deemed re-treatment appropriate. Time to the participant's first qualification for 2nd treatment from the day of 1st treatment was calculated as the earliest date when participants fulfilled the qualification for retreatment criteria minus the day of first treatment plus 1.|Up to 36 weeks in Treatment Cycle 1|FAS1 Population.|||Days||95% Confidence Interval|Median
2551199|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes|"Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day."|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percentage of participants|||Number
2551200|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes|"Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day."|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percentage of participants|||Number
2551201|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Urgency Incontinence Episodes|"Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day."|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percentage of participants|||Number
2551203|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Percentage of Participants Attaining 100%, >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes|"Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated using formula; number of Yes response to the diary question of Did you have accidental urinary leakage? divided by number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day."|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percentage of participants|||Number
2551204|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Percentage of Participants Attaining 100 Percent (%), >=75% and >=50% Reduction From Baseline in the Daily Average of Urinary Incontinence Episodes|"Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated using formula; number of Yes response to the diary question of Did you have accidental urinary leakage? divided by number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day."|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percentage of participants|||Number
2551205|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline|"Urgency intensity was determined using a 4-point scale ranging from 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe) as part of the bladder diary, during the 3-day diary collection period. Maximum was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit. Results have been presented for improvement (3 point, 2 point, 1 point improvement and no change) as well as for worsening (1 point, 2 point, 3 point worsening) of urgency intensity. Maximum possible scale range is 0 to 3. 3 point improvement means change in intensity from severe to none. 3 point worsening means change in intensity from none to severe. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day."|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2551206|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline|"Urgency intensity was determined using a 4-point scale ranging from 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe) as part of the bladder diary, during the 3-day diary collection period. Maximum was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit. Results have been presented for improvement (3 point, 2 point, 1 point improvement and no change) as well as for worsening (1 point, 2 point, 3 point worsening) of urgency intensity. Maximum possible scale range is 0 to 3. 3 point improvement means change in intensity from severe to none. 3 point worsening means change in intensity from none to severe. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day."|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2551207|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Improvement and Worsening in Maximum Urgency Intensity From Baseline|"Urgency intensity was determined using a 4-point scale ranging from 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe) as part of the bladder diary, during the 3-day diary collection period. Maximum was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit. Results have been presented for improvement (3 point, 2 point, 1 point improvement and no change) as well as for worsening (1 point, 2 point, 3 point worsening) of urgency intensity. Maximum possible scale range is 0 to 3. 3 point improvement means change in intensity from severe to none. 3 point worsening means change in intensity from none to severe. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day."|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2551208|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Number of Participants With Maximum Urgency Intensity|"The daily average number of urgency episodes categorized by each urgency intensity as no urgency (None), mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Maximum was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit."|Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2551209|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Number of Participants With Maximum Urgency Intensity|"The daily average number of urgency episodes categorized by each urgency intensity as no urgency (None), mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Maximum was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit."|Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2551210|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Number of Participants With Maximum Urgency Intensity|"The daily average number of urgency episodes categorized by each urgency intensity as no urgency (None), mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Maximum was defined as the maximum urgency intensity within 3-day period (but only for valid diary day) in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day."|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2551211|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes|The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency), '1' (mild urgency), '2' (moderate urgency), '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe or moderate urgency episodes was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Episodes||Standard Deviation|Mean
2551212|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes|The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency), '1' (mild urgency), '2' (moderate urgency), '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe or moderate urgency episodes was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Episodes||Standard Deviation|Mean
2551213|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe or Moderate Urgency Episodes|The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency), '1' (mild urgency), '2' (moderate urgency), '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe or moderate urgency episodes was calculated as any visit value minus Baseline value.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Episodes||Standard Deviation|Mean
2551214|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Severe Urgency Episodes|The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe urgency episodes was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Episodes||Standard Deviation|Mean
2551215|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Severe Urgency Episodes|The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe urgency episodes was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Episodes||Standard Deviation|Mean
2551216|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Severe Urgency Episodes|The daily average number of urgency episodes categorized by each urgency intensity as no urgency, mild urgency, moderate urgency and severe urgency. Urgency episodes were calculated by a 4-point scale ranging from '0' (No urgency) to '3' (Severe urgency), as part of the bladder diary, during the 3-day diary collection period. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline in daily average number of severe urgency episodes was calculated as any visit value minus Baseline value.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Episodes||Standard Deviation|Mean
2551426|NCT02817841|Secondary|Number of Unscheduled Bleeding Days Per Cycle|Unscheduled bleeding is defined as any bleeding that occurs while taking active hormones that does not meet the criteria for scheduled bleeding and/or spotting.|Up to 11 months (12 cycles with 1 cycle = 28 days)|Participants aged 16 to 50 years, inclusive, at screening, with evaluable cycle data for the bleeding analysis.|||Days||Standard Deviation|Mean
2551217|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes|Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3|FAS3 Population. All the participants in this population were analyzed (56, 43 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2551218|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes|Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2|FAS2 Population. All the participants in this population were analyzed (108, 88 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2551219|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Percentage Changes From Baseline in Daily Average Number of Nocturia Episodes|Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2551220|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Nocturia Episodes|Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Episodes||Standard Deviation|Mean
2551221|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Nocturia Episodes|Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Episodes||Standard Deviation|Mean
2551222|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Nocturia Episodes|Nocturia episodes are voids (micturition episodes) that interrupt night sleep. The daily average number of nocturia episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of episodes that awake participants from night sleep with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Episodes||Standard Deviation|Mean
2551223|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urgency Episodes|"The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of Yes response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100."|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2551224|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urgency Episodes|"The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of Yes response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100."|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2551225|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urgency Episodes|"The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of Yes response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100."|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2551226|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urgency Episodes|"The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of Yes response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value."|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Episodes||Standard Deviation|Mean
2551227|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urgency Episodes|"The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of Yes response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value."|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Episodes||Standard Deviation|Mean
2551228|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urgency Episodes|"The daily average number of urgency episodes were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of Yes response to the diary question of episode associated with a sudden and urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value."|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Episodes||Standard Deviation|Mean
2551229|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Average Volume Voided Per Micturition|The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2551230|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Average Volume Voided Per Micturition|The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2551307|NCT02819804|Primary|Incidence of Dose-Limiting Toxicity (DLT)|Determine the maximum tolerated dose (MTD) of nivolumab when given in combination with dasatinib, the MTD will be defined as the highest dose level at which ≤ 1 DLT occurs and will be assessed by the Common Terminology Criteria for Adverse Events version 4.03.|Up to 28 days|Only one patient was treated on study and this patient did not complete the DLT period and was not evaluable for this outcome measure or any of the outcome measures. Sample size too small for analysis.||||||
2551231|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Average Volume Voided Per Micturition|The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2551232|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Average Volume Voided Per Micturition|The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Milliliter||Standard Deviation|Mean
2551233|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Average Volume Voided Per Micturition|The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Milliliter||Standard Deviation|Mean
2551234|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Average Volume Voided Per Micturition|The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Milliliter||Standard Deviation|Mean
2551235|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Voids|The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2551236|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Voids|The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2551237|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Voids|The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2551308|NCT02819726|Other Pre-specified|Pharmacodynamic Endpoint: Change From Baseline in C-reactive Protein (CRP) Levels at Weeks 8, 16, 24, 36 and 52|Pharmacodynamic endpoint: Change from baseline (Day 1) in C-reactive protein (CRP) levels (mg/dL) at weeks 8, 16, 24, 36 and 52 (EOS)|Baseline (Day 1) and Weeks 8, 16, 24, 26 & 52 (EOS)|Pharmacodynamic Analysis Set|||Mg/dL||Standard Deviation|Mean
2557468|NCT02709330|Secondary|Frequency of ALS Reversals|The percentage of enrolled participants experiencing an ALSFRS-R improvement of at least 4 points lasting at least 12 months.|Screening/baseline - Month 12||||percentage of participants|||Number
2551238|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Voids|The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Voids||Standard Deviation|Mean
2551239|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Voids|The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Voids||Standard Deviation|Mean
2551240|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Voids|The daily average number of micturition episodes (voids) were calculated from bladder diary data recorded by the participant during the 3-day diary collection period, by dividing the number of 'Yes response to the diary question of urination into the toilet with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Voids||Standard Deviation|Mean
2551241|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes|The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2551242|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes|The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2551243|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes|The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2551244|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes|The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Episodes||Standard Deviation|Mean
2551269|NCT02820038|Secondary|Mean Fatigue at 6-Month Follow-up Adjusted for Baseline|Fatigue will be assessed using the Neuro-QOL (Quality of Life in Neurological Disorders) Version 1 item bank. Raw scores are rescaled to a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. The United States general population is used as the reference group. A higher T-score represents greater fatigue.Thus, a person who has a T-score of 70 is two SDs above the average level of fatigue observed in the referenced population.|Month 6 Follow-up|Includes 206 participants with non-missing data at baseline and at the 6-month follow-up. (Excludes 80 people with missing data.)|||score on a scale||Standard Error|Least Squares Mean
2551245|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes|The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Episodes||Standard Deviation|Mean
2551246|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in Daily Average Number of Urinary Urgency Incontinence Episodes|The daily average number of urge incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage and sudden/ urgent need to urinate with the number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Episodes||Standard Deviation|Mean
2551247|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes|Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes was calculated from bladder diary data recorded by the participants during the 3-day diary collection period by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2551248|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes|Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes was calculated from bladder diary data recorded by the participants during the 3-day diary collection period by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30 and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2551249|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Percentage Change From Baseline in Daily Average Number of Urinary Incontinence Episodes|Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes was calculated from bladder diary data recorded by the participants during the 3-day diary collection period by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Percentage change from Baseline was calculated as post-dose visit value minus Baseline, divided by Baseline and multiplied by 100.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2551250|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 3): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes|Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. FAS3 Population comprised of all randomized participants who had at least 1 post-3rd treatment efficacy assessment after 3rd treatment.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18 and Week 24 in Treatment Cycle 3|FAS3 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Episodes||Standard Deviation|Mean
2551290|NCT02819908|Secondary|Slit Lamp (Cornea Exam)||To end of study (1 month postop)|Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report||||||
2551291|NCT02819908|Secondary|Change in Corneal Thickness|Based on corneal pachymetry|To end of study (1 month postop)|Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report||||||
2551251|NCT02820844|Secondary|Treatment Phase 2 (Treatment Cycle 2): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes|Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. FAS2 Population comprised all randomized participants who had at least 1 post-2nd treatment efficacy assessment after 2nd treatment.|Baseline (Pre-dose of Treatment Cycle 1), Week 0, Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, and Week 36 in Treatment Cycle 2|FAS2 Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Episodes||Standard Deviation|Mean
2551252|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Changes From Baseline in Daily Average Number of Urinary Incontinence Episodes|Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated from bladder diary data recorded by the participants during the 3-day diary collection period, by dividing the number of 'Yes' response to the diary question of accidental urinary leakage with number of valid diary days in the visit. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value.|Baseline (Pre-dose on Day 1), Week 2, Week 6, Week 12, Week 18, Week 24, Week 30, Week 36, Week 42 and Week 48 in Treatment Cycle 1|FAS1 Population. All the participants in this population were analyzed (124, 124 participants) but only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Episodes||Standard Deviation|Mean
2551253|NCT02820844|Secondary|Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Average Volume Voided Per Micturition at Week 12 After the First Treatment|The total volume voided was measured and recorded by participants in the bladder diary, over a 24-hour period during the 3-day diary collection period. Volume voided per micturition was determined by dividing the total urine volume collected in 24-hour period by the participants with the number of the urinary volume records which are not missing. Baseline is the latest pre-dose 3-day diary assessment which has at least one valid diary day. Change from Baseline was calculated as any visit value minus Baseline value. Adjusted mean and standard error of adjusted mean has been reported.|Baseline (Pre-dose on Day 1) and Week 12 in Treatment Cycle 1|FAS1 Population. Only those participants with data available at specified time point were analyzed.|||Milliliter||Standard Error|Mean
2551254|NCT02820844|Primary|Treatment Phase 1 (Treatment Cycle 1): Change From Baseline in the Daily Average Number of Urinary Incontinence Episodes at Week 12 After the First Treatment|"Participants were instructed to enter data in a bladder diary over 3 consecutive days within a week prior to each scheduled visit (or within 28 days prior to Day 1), excluding the day of visit (this period was called the '3-day diary collection period'). The daily average of the number of incontinence episodes were calculated using formula; number of Yes response to the diary question of accidental urinary leakage divided by number of valid diary days in the visit. Baseline is the latest pre-dose 3- day diary assessment which has at least one valid diary day. Change from Baseline is any visit value minus Baseline value. Adjusted mean and standard error of adjusted mean has been reported."|Baseline (Pre-dose on Day 1) and Week 12 in Treatment Cycle 1|Full Analysis Set 1(FAS1) Population comprised of all randomized participants who had at least 1 post-Baseline efficacy assessment. Only those participants with data available at specified time point were analyzed.|||Episodes||Standard Error|Mean
2551255|NCT02820597|Secondary|Device- and/or Procedure-related Adverse Events|All adverse events evaluated as possibly, probably, or definitely related to the ClariFix device and/or procedure.|Baseline through 90 days post treatment|All treated participants.|||Participants|||Count of Participants
2551256|NCT02820597|Secondary|Ease of Use|Physician evaluation of ClariFix ease of use. After each participant's treatment, the physician was asked to rate the ClariFix on ease of use. Options were easy, moderately easy, moderately difficult, or difficult.|Immediately post treatment|Physician evaluation of ease of use after each ClariFix procedure.|||Procedures|Procedures||Count of Units
2551257|NCT02820597|Primary|Change in Rhinitis Symptoms (VAS)|Change from baseline in rhinitis symptoms measured on a participant-reported visual analog scale (VAS). Symptoms of rhinorrhea, nasal breathing, facial pain/pressure, and sense of smell were rated from 0 (no symptoms) to 10 (severe/extremely bothersome symptoms) assessed over the 12 hours preceding the visit. An average of the 4 individual scores was used as the total VAS score with a range of 0 to 10.|Baseline through 365 days post treatment|All treated participants with follow-up at the indicated visits.|||score on a scale||Standard Deviation|Mean
2551258|NCT02820597|Primary|Change in Rhinitis Symptom Severity (rTNSS)|Change from baseline in participant-reported symptom severity based on the rTNSS (Reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. The rTNSS has a possible score range of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 12 hours.|Baseline through 365 days post treatment|All participants with follow-up at the indicated visits.|||score on a scale||Standard Deviation|Mean
2551259|NCT02820597|Primary|Device- and/or Procedure-related Serious Adverse Events|Number of participants with device- and/or procedure-related serious adverse events reported over the initial study follow-up period.|Baseline through 365 days post treatment|A total of 27 subjects were enrolled and received bilateral cryosurgery with the ClariFix device (n=54 treatments).|||participants|||Number
2551292|NCT02819908|Primary|The Change in Intraocular Pressure (IOP) From Baseline|Based on Goldmann tonometry|To end of study (1 month postop)|Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report||||||
2551293|NCT02819804|Other Pre-specified|Presence of Resistance Mutations in Bone Marrow at the Time of Disease Progression||Up to 28-days after the last dose|||||||
2551260|NCT02820038|Other Pre-specified|Percentage of Participants Using a DMARD (Disease-Modifying Antirheumatic Drug) at 6-Month Follow-up|"DMARD usage will be assessed via online questionnaires. Participants will be shown a checklist of 19 medications used to treat RA (abatacept, adalimumab, azathioprine, certolizumab pegol, cyclosporine, etanercept, golimumab, gold, hydroxychloroquine, infliximab, leflunomide, methotrexate pill, methotrexate shot, minocycline, rituximab, sulfasalazine, tocilizumab infusion, tocilizumab shot, and tofacitinib) and asked to check all of those that they are currently using. Participants will also be to check an option labeled None of the above. DMARD Usage will be scored as 0 if the participant reports using no DMARDS and 1 if the participant reports using one or more DMARDS."|Month 6 Follow-up|Includes 220 participants who completed the measure assessing medication use at the 6-month follow-up. (Excludes 66 people who had missing data at the 6-month follow-up.)|||percentage of participants|||Number
2551261|NCT02820038|Other Pre-specified|Patient Interest in Information About Treatment Options: Number of Pages Viewed|After participants complete the baseline questionnaire, they were directed to a website that provides written prescription drug information for medications used to treat RA. From baseline to the 6-month follow-up, the investigators electronically tracked the number of webpages viewed and whether participants viewed any of the webpages.|6 months||||pages viewed||Standard Deviation|Mean
2551262|NCT02820038|Other Pre-specified|Patient Interest in Information About Treatment Options: Viewed at Least One Webpage|After participants complete the baseline questionnaire, they were directed to a website that provides written prescription drug information for medications used to treat RA. From baseline to the 6-month follow-up, the investigators electronically tracked the number of webpages viewed and whether participants viewed any of the webpages.|6 months|This was an intent to treat analysis. Includes all 286 individuals who were given access to the written prescription drug information.|||Participants|||Count of Participants
2551263|NCT02820038|Secondary|Mean Verbatim Recall of Information Concerning Medication Benefits and Risks|Verbatim recall of information concerning potential medication benefits and harms will be assessed by medication-specific items developed specifically for this study. For each medication, the investigators will identify one potential benefit and one potential harm listed in the Drug Facts Box. Each question will ask participants about the probability of benefit/harm using a multiple-choice response format. To minimize response burden, participants will be asked these questions in relation to only one of their current RA medications. Correct responses will be summed across the benefit and harm items to yield a score ranging from 0 to 2. Higher numbers reflect greater verbatim recall.|6 weeks|Includes 190 participants who completed the Verbatim Recall measure at the 6-month follow-up. (Excludes 96 people who had missing data at the 6-month follow-up.)|||score on a scale||Standard Error|Mean
2551264|NCT02820038|Secondary|Mean Medication Self-Management Knowledge|Medication Self-Management Knowledge will be assessed using a 45-item medication-specific measure tailored to the medications each participant reports using and developed specifically for this study. The questions will draw on information found in the medication information provided to participants. Correct answers will be summed across the 45 items. Scores transformed to a 100-point scale (ranging from 0-100) with higher values reflecting greater knowledge.|6 months|Includes 189 participants who had responded to the Medication Self-Management Knowledge items at the 6-month follow-up. (Excludes 97 people who had missing data at the 6-month follow-up.)|||score on a scale||Standard Error|Mean
2551265|NCT02820038|Secondary|Mean Visual Selective Learning at 6-Month Follow-up Adjusted for Baseline|The Visual Selective Learning (VSL) task will be administered as part of telephone interviews by showing participants 3 lists of 16 words via a PowerPoint presentation embedded in a YouTube video. Each word will appear on a separate screen for 1 second. Half of the words will be in uppercase and half will be in lowercase. In some trials, participants will be instructed that uppercase words are valued at 10 points and lowercase words at 1 point; in other trials, the point value was the opposite. Participants will be told to remember as many words as they could, but that their goal is to earn as many points as possible. Different word lists will be used at each time point and the lists will be balanced across participants over the course of the study using procedures parallel to those for the TOSL. At each time point, scores will be summed across the three lists, yielding a composite score with a possible range from 0 to 264, with higher numbers reflect greater VSL.|Month 6 Follow-up|Includes 224 participants who completed the Visual Selective Learning measure at the 6-month follow-up. (Excludes 62 people who had missing data at the 6-month follow-up.)|||score on a scale||Standard Error|Mean
2551266|NCT02820038|Secondary|Information Seeking: Use of RA Self-Management Website|The investigators created a website that provided easy access to information about RA, treatment options, and self-management strategies. Participants were emailed a link to this website immediately after completion of 6-week follow-up data collection. The investigators used Google analytics to track whether participants accessed the website.|6 months|This was an intent to treat analysis. Includes all 265 participants who were given access to the RA Self-Management Website. (Excludes 21 people who withdrew from the study before being given access to this website.)|||Participants|||Count of Participants
2551267|NCT02820038|Secondary|Information Seeking: Participating in BetterChoices, BetterHealth|After the 6 week follow-up interview, all participants were given an opportunity to take part in the BetterChoices, BetterHealth program. To assess information seeking, the investigators tracked whether or not participants enrolled in the class and attended at least one class session. This variable was coded such that: 0=Either did not enroll or did not attend any class sessions, 1=Enrolled and attended at least one class session.|6 months|Includes 277 participants with non-missing data at baseline and at the 6-month follow-up. (Excludes 9 people with missing data.)|||Participants|||Count of Participants
2551268|NCT02820038|Secondary|Mean Health Literacy at 6-Month Follow-up Adjusted for Baseline|Health literacy will be assessed via the Newest Vital Sign (NVS). This instrument, which tests literacy skills for both numbers and words, has been validated against a previously validated measure of health literacy (the TOFHLA). Participants are given a specially designed ice cream nutrition label to review and are asked a series of questions about the label. 1-point is given for each correct answer (maximum of 6 points). Scores transformed to a 100-point scale (ranging from 0-100) with higher values reflecting greater health literacy.|Month 6 Follow-up|Includes 203 participants with non-missing data at baseline and at the 6-month follow-up. (Excludes 83 people with missing data.)|||score on a scale||Standard Error|Least Squares Mean
2557469|NCT02709330|Secondary|Retention Rate|Percentage of surviving participants who completed the month 12 visit.|Month 12||||percentage of participants|||Number
2551270|NCT02820038|Secondary|Mean Depression at 6-Month Follow-up Adjusted for Baseline|Depression will be assessed using the Neuro-QOL (Quality of Life in Neurological Disorders) Version 1 item bank. Raw scores are rescaled to a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. The United States general population is used as the reference group. A higher T-score represents greater depression.Thus, a person who has a T-score of 70 is two SDs above the average level of depression observed in the referenced population.|Month 6 Follow-up|Includes 207 participants with non-missing data at baseline and at the 6-month follow-up. (Excludes 79 people with missing data.)|||score on a scale||Standard Error|Least Squares Mean
2551271|NCT02820038|Secondary|Mean Disease Activity at 6-Month Follow-up Adjusted for Baseline|Disease Activity will be assess using the Routine Assessment of Patient Index Data 3 (RAPID3). This instrument is based on the Multi-Dimensional Health Assessment Questionnaire (MDHAQ), which is adapted from the standard HAQ. The RAPID3 includes the 3 Core Data Set measures of physical function, pain, and patient global estimate. The score for physical function ranges from 0 to 10 and is calculated by adding the ten activities of daily living, each scored from 0 to 3 by the patient and dividing the total raw score by 3. Pain and global estimate of health are measured on a likert scale from 0 to 10. The three 0-10 scores for physical function, pain, and global assessment of health are added together and divided by 3 to create a composite score, ranging from 0 to 10. Higher values reflect greater disease activity.|Month 6 Follow-up|Includes 209 participants with non-missing data at baseline and at the 6-month follow-up. (Excludes 77 people with missing data.)|||score on a scale||Standard Error|Least Squares Mean
2551272|NCT02820038|Secondary|Mean Global Health Status at 6-Month Follow-up Adjusted for Baseline|This outcome will be assessed by a single-item asking participants to rate their current health on a 5-point scare where 1=Poor, 2=Fair, 3= Good, 4= Very Good, and 5= Excellent. This item is part of the Medical Outcomes Study Core Survey Instrument and responses have been shown to predict mortality and health care utilization as well as multi-item health status measures.|Month 6 Follow-up|Includes 210 participants with non-missing data at baseline and at the 6-month follow-up. (Excludes 76 people with missing data.)|||score on a scale||Standard Error|Least Squares Mean
2551273|NCT02820038|Secondary|Mean Health Distress at 6-Month Follow-up Adjusted for Baseline|Health Distress will be assessed by the 4-item measure developed by Lorig and colleagues. This measure was adapted from the Medical Outcomes Study health distress scare for use in arthritis populations. The adapted measure has demonstrated high internal consistency (Cronbach's alpha= .87) and responsiveness to change following completion of an arthritis self-management course. Participants will respond to each question on a 6-point scale, ranging from None of the Time (0) to All of the Time (5). Thus, the total score will range from 0 to 5, with higher scores reflecting greater Health Distress.|Month 6 Follow-up|Includes 208 participants with non-missing data at baseline and at the 6-month follow-up. (Excludes 78 people with missing data.)|||score on a scale||Standard Error|Least Squares Mean
2551274|NCT02820038|Secondary|Mean Illness Intrusiveness at 6-Month Follow-up Adjusted for Baseline|"Illness Intrusiveness will be assessed by the 13-item Illness Intrusiveness Ratings Scale. Items ask respondents to rate the degree to which their illness and/or its treatment interferes with aspects of life that are essential for quality of life. Responses will be recorded on a visual analog scale, with endpoints labeled Not Very Much (0) and Very Much (100). The instrument will be scored by summing across all items and dividing by the number of items answered to yield a total score ranging from 0 to 100 where higher values reflect greater illness intrusiveness."|Month 6 Follow-up|Includes 205 participants with non-missing data at baseline and at the 6-month follow-up. (Excludes 81 people with missing data.)|||score on a scale||Standard Error|Least Squares Mean
2551275|NCT02820038|Secondary|Mean Medication Adherence at 6-Month Follow-up Adjusted for Baseline|"Medication Adherence was assessed by a single question that asked: All things considered, how much of the time do you use your RA medications EXACTLY as directed? Responses were recorded on a 100-point visual analog scale with endpoints labeled None of the Time and All of the time. Higher values reflect greater medication adherence."|Month 6 Follow-up|Includes 181 participants with non-missing data at baseline and at the 6-month follow-up. (Excludes 105 people with missing data.)|||score on a scale||Standard Error|Least Squares Mean
2551276|NCT02820038|Secondary|Mean Arthritis Self-Efficacy at 6-Month Follow-up Adjusted for Baseline|"The investigators will assess confidence in one's ability to manage arthritis symptoms in different situations via the 8-item Arthritis Self-Efficacy Scale (e.g., keep pain from interfering with things participants want to do). Responses are recorded on a 100-point scale with endpoints labeled Very Uncertain and Very Certain. This measure has been widely used in arthritis patient populations for over two decades and has been shown to have excellent psychometric properties, including high internal consistency (Cronbach's alpha generally exceeds 0.90) and sensitivity to change following participation in illness self-management programs. To create a total scale score, the investigators summed participant responses across the items in the scale and divided by the number of items answered. Thus, the scale has a possible range of 0 to 100. Higher scores indicate greater self-efficacy."|Month 6 Follow-up|Includes 202 participants with non-missing data at baseline and at the 6-month follow-up. (Excludes 84 people with missing data.)|||score on a scale||Standard Error|Least Squares Mean
2551277|NCT02820038|Secondary|Mean Overall Treatment Satisfaction at 6-Month Follow-up Adjusted for Baseline|The Treatment Satisfaction Questionnaire for Medication (TSQM-9) will be used to assess treatment satisfaction. TSQM-9 has 3 subscales: effectiveness, convenience and overall satisfaction. Items ask participants to rate their satisfaction with difference aspect of their treatment regimen on a 7-point scale with endpoints labeled, Extremely Dissatisfied (1) and Extremely Satisfied (7). Internal consistency of each subscale has been demonstrated with Cronbach's alpha exceeding 0.80 for each sub-scale. Each subscale has been shown to discriminate between individuals classified as exhibiting Low vs. Medium medication adherence. The investigators combined items across all three subscales to yield a measure of overall treatment satisfaction (range: 0 to 100, with higher scores reflecting greater satisfaction).|Month 6 Follow-up|Includes 210 participants with non-missing data at baseline and at the 6-month follow-up. (Excludes 76 people with missing data.)|||score on a scale||Standard Error|Least Squares Mean
2551294|NCT02819804|Other Pre-specified|Compare the OS Between Patients Who Receive a Hematopoietic Stem Cell Transplant and Those Who Receive no Further Therapy Following Remission||Up to 1 year|||||||
2551295|NCT02819804|Other Pre-specified|Duration of Remission (DOR)|Duration of remission is defined as the time from achieving complete response until the time of disease relapse.|Up to 1 year|||||||
2551278|NCT02820038|Secondary|Mean Satisfaction With Medication Information at 6-Month Follow-up Adjusted for Baseline|This outcome will be assessed by the 17-item Satisfaction with Information about Medicines Scale (SIMS). Items ask participants to rate the amount of information they have received about different aspects of their medications. Responses are summed across items to yield a total score with a possible range of 0 to 17, with higher scores reflecting greater satisfaction with the amount of information received.|Month 6 Follow-up|Includes 206 participants with non-missing data at baseline and at the 6-month follow-up. (Excludes 80 people with missing data.)|||score on a scale||Standard Error|Mean
2551279|NCT02820038|Secondary|Mean Gist Reasoning Ability, Complex Abstraction at 6-Month Follow-up Adjusted for Baseline|"The investigators used the Test of Strategic Learning (TOSL) to quantify participants' ability to abstract gist meanings from complex text. The TOSL consists of 4 text passages varying in length (from 291 to 575 words) and complexity. Each participant responded to one passage at each time point. Participants were asked to provide a summary of the original text, focused on bottom-line-meaning rather than specific details. Responses were scored to assess the number of abstracted ideas (Complex Abstraction, range 0 to 8) using an objective scoring system by a trained and experienced rater, blinded to participants' group assignment and time point of testing. Higher scores indicate more ideas abstracted.~The investigators will assess change in the total score over time from baseline to 6 month follow-up."|Month 6 Follow-up|Includes 177 participants with non-missing data at baseline and at the 6-month follow-up. (Excludes 109 people with missing data.)|||score on a scale||Standard Error|Least Squares Mean
2551280|NCT02820038|Secondary|Mean Gist Reasoning Ability, Lesson Quality at 6 Month Follow-up Adjusted for Baseline|The investigators used the Test of Strategic Learning (TOSL) to quantify participants' ability to abstract gist meanings from complex text. The TOSL consists of 4 text passages varying in length (from 291 to 575 words) and complexity. Each participant responded to one passage at each time point. Participants were asked to provide a summary of the original text, focused on bottom-line-meaning rather than specific details. Responses were scored to assess the quality of high-level interpretations (Lesson Quality, range 0 to 5) using an objective scoring system by a trained and experienced rater, blinded to participants' group assignment and time point of testing. Higher scores reflect better lesson quality.|Month 6 Follow-up|Includes 177 participants with non-missing data at baseline and at the 6-month follow-up. (Excludes 109 people with missing data.)|||score on a scale||Standard Error|Least Squares Mean
2551281|NCT02820038|Secondary|Mean Values at 6-Months Adjusted for Baseline|Values. Questions included in the self-administered questionnaires asked participants to indicate the extent to which they agreed or disagreed with 10 simple values statements (e.g., It is OK to ignore the risk of a serious side effect if it is extremely rare; It is better to continue with the pain I know than to change my medications) developed by Fraenkel and colleagues. Responses were recorded on a 4-point scale ranging from 1=Strongly Agree to 4=Strongly Disagree. Responses were then summed and rescored to yield a composite scale that ranged from -15 to +15, where positive numbers reflected values favoring the use of medications to control rheumatoid arthritis (RA) disease activity.|Month 6 Follow-up|Includes 218 participants with non-missing data at baseline and at the 6-month follow-up. (Excludes 68 people with missing data.)|||score on a scale||Standard Error|Least Squares Mean
2551282|NCT02820038|Secondary|Mean Knowledge of the Risks and Benefits Associated With DMARD Therapy at 6 Months Adjusted for Baseline|Knowledge of DMARD risks and benefits will be assessed by measures developed by Fraenkel et al., Barton et al., and Fayet et al. The combined measure will have a total of 36 items. Most items are answered on a true/false scale (with a don't know option provided). Each correct response will receive 1-point (maximum of 36 points). Scores transformed to a 100-point scale (ranging from 0-100) with higher values reflecting greater knowledge.|Month 6 Follow-up|Includes 223 participants who had sufficient data to classify as either meeting or not meeting the criteria for informed decision-making at the 6-month follow-up. (Excludes 63 people who had missing data at the 6-month follow-up.)|||score on a scale||Standard Error|Least Squares Mean
2551283|NCT02820038|Primary|Percentage of Participants Classified as Having Made an Informed Decision at 6 Months|Informed decision making is characterized by making a value-consistent decision based on accurate knowledge. Knowledge will be assessed as described under Outcome 2. Values will be assessed using a 10-item scale developed by Fraenkel et al. Scores on this scale can range from 0 to 10, with lower scores reflecting a reluctance to use medications to control disease activity. Participants will be classified as having made an informed choice if they: (1) answered at least 85% of the knowledge items correctly, scored 6 or more on the values scale, and are currently taking one or more DMARDS OR (2) answered 85% of the knowledge items correctly, scored 5 or less on the values measure, and are not currently taking a DMARD. Otherwise, individuals will be classified as not having made an informed choice.|Month 6 Follow-up|Includes 221 participants who had sufficient data to classify as either meeting or not meeting the criteria for informed decision-making at the 6-month follow-up. (Excludes 65 people who had missing data at the 6-month follow-up.)|||percentage of participants|||Number
2551284|NCT02819908|Other Pre-specified|The Change From Baseline in Macular Thickness Measurements|based on optical coherence tomography (OCT) measurement|To end of study (1 month postop)|Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report||||||
2551285|NCT02819908|Other Pre-specified|The Change From Baseline in Central Corneal Thickness Measurements|corneal pachymetry|To end of study (1 month postop)|Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report||||||
2551286|NCT02819908|Other Pre-specified|The Change From Baseline in Visual Symptoms|visual symptom scale|To end of study (1 month postop)|Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report||||||
2551287|NCT02819908|Other Pre-specified|"The Proportion of Subjects Reporting no Visual Symptoms (0 )"|visual symptom scale|To end of study (1 month postop)|Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report||||||
2551288|NCT02819908|Other Pre-specified|Change From Baseline Eye Pain/Discomfort|eye pain/discomfort scale|To end of study (1 month postop)|Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report||||||
2551289|NCT02819908|Other Pre-specified|Subject Reporting no Eye Pain|"0( on the eye pain/discomfort scale)"|To end of study (1 month postop)|Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report||||||
2551309|NCT02819726|Other Pre-specified|Pharmacodynamic Endpoint: Change From Baseline in CD19+ B-cell Count During the Study Period|Pharmacodynamic endpoint: Descriptive statistics (mean [SD]) of the change from baseline in CD19+ B-cell count during the study period (Day 15 [AUEC(0-d15] and Week 24 [AUEC(0-w24])|Samples for pharmacodynamic evaluation (CD19+ B-cell) were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.|Pharmacodynamic Analysis Set. participants in the SAIT101 arm, Twenty three participants in the MabThera arm, 20 participants in the MabThera and 20 participants in the Rituxan arm were excluded from the analysis either as they had a depleted C-cell count at baseline and / or the Week 24 assessment was missing.|||Cells*day/µL||Standard Deviation|Mean
2551310|NCT02819726|Other Pre-specified|Pharmaco Endpoint: Area Under the Concentration Time Curve of CD19 B-cell Count Change at Day 15 and Week 24|Area under the concentration time curve of CD19 B-cell count change at Day 15 (AUEC0-d15) and week 24 (AUEC0-w24) based on change from baseline and percent of baseline values|Samples for pharmacodynamic evaluation (CD19+ B-cell) were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20, 24, 36 and 52. Unscheduled visit samples were taken at the discretion of the investigator.|Pharmacodynamic Analysis Set. AUC0-d15 could not be determined for 23 participants in the SAIT101 arm, 20 participants in the MabThera arm and 20 participants in the Rituxan arm as either the baseline data was missing and /or there was a missing b-cell could at the last timepoint.|||cells*day/µL)||95% Confidence Interval|Least Squares Mean
2551311|NCT02819726|Other Pre-specified|Pharmacodynamic Endpoint: Number of Participants With CD19+ B-cell Count Recover Versus Baseline|Number of participants with CD19+ B-cell count recover versus baseline. Incidence of B-Cell recovery was defined as either CD19+ B-cell counts retuned to baseline or the lower limit or normal of 110 cells/µL at week 24).|Samples for pharmacodynamic evaluation (CD19+ B-cell) were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20, 24, 36 and 52. Unscheduled visit samples were taken at the discretion of the investigator.|Pharmacodynamic Analysis Set|||Participants|||Count of Participants
2551312|NCT02819726|Other Pre-specified|Pharmacodynamic Endpoint: Duration of CD19+ B-cell Depletion|Duration of CD19+ B-cell depletion (only participants that returned to non-depletion at or before week 24 were included)|Samples for pharmacodynamic evaluation (CD19+ B-cell) were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20, 24, 36 and 52. Unscheduled visit samples were taken at the discretion of the investigator.|Pharmacodynamic Analysis Set.Pharmacodynamic Analysis Set. Fifty seven participants in the SAIT101 arm, 70 participants in the MabThera arm and 72 participants in the Rituxan arm were excluded from the analysis either as they had a depleted C-cell count at baseline or if the Week 24 assessment was missing.|||Days||Standard Deviation|Mean
2551313|NCT02819726|Other Pre-specified|Pharmacodynamic Endpoint: Time Needed to CD19+ B-cell Depletion|Time needed to CD19+ B-cell depletion in Part A (calculated as the first time CD19+ B-cell count below 20/µL minus time of first dosing in days).|Samples for pharmacodynamic evaluation (CD19+ B-cell) were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20, 24, 36 and 52. Unscheduled visit samples were taken at the discretion of the investigator.|Pharmacodynamic Analysis Set. Two participants in the SAIT101 arm, 3 participants in the MabThera arm and 3 participants in the Rituxan arm were excluded from the analysis either as they had a depleted C-cell count at baseline and / or if the Week 24 assessment was missing.|||Days||Standard Deviation|Mean
2551314|NCT02819726|Other Pre-specified|Pharmacodynamic Endpoint: Depletion of B-lymphocyte Antigen CD19 (CD19+) B-cell Count up to Week 24|Pharmacodynamic endpoint: proportion of participants (n) with depletion of CD19+ B-cell count up to week 24 (Pharmacodynamic analysis set).|Samples for pharmacodynamic evaluation (CD19+ B-cell) were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.|Pharmacokinetic data set|||participants|||Number
2551315|NCT02819726|Secondary|Pharmacodynamic Endpoint: Change From Baseline in Immunoglobulin (IgG, IgM and IgA Levels)|Change from baseline (Day 1) in immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) levels (mg/dL) at Week 8, 16, 24 36 and 52 (End of study)|Baseline (Day 1) and Weeks 8, 16, 24, 36 and 52 (EOS)|Pharmacodynamic Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).|||Mg/dL||Standard Deviation|Mean
2551316|NCT02819726|Secondary|Proportion of Participants With European League Against Rheumatism (EULAR) Response at Weeks 8, 16, 24 36 and 52|Efficacy endpoint: Proportion of participants with European League Against Rheumatism (EULAR) response (defined as good response, moderate response or no response) at weeks 8, 16, 24 36 and 52 (EOS). EULAR (European League Against Rheumatism) response was classified using the individual amount of change in the DAS28-CRP score. The DAS28-CRP was classified into 3 categories: low disease activity (<= 3.2), moderate disease activity (> 3.2 and <= 5.1) and high disease activity (> 5.1). Good response was defined as >1.2 improvement in the DAS28-CRP from baseline with low disease activity.|Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)|Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).|||participants||95% Confidence Interval|Number
2551317|NCT02819726|Secondary|Number of Participants With a Clinical Remission Response (CRR) at Weeks 8, 16, 24, 36 and 52|Number if Participants with a Clinical Remission Response (CRR) defined by the Simplified Disease Activity Index (SDAI) <3.3 at weeks 8, 16, 24, 36 and 52 (EOS).|Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)|Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).|||participants||95% Confidence Interval|Number
2551333|NCT02819726|Secondary|Time to Maximum Plasma Concentration (Tmax) (Dose 2)|Time of maximum concentration postinfusion over the second dosing interval, obtained directly from the observed concentration versus time data.|Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.|Pharmacokinetic Analysis Set|||Hours||Inter-Quartile Range|Median
2551318|NCT02819726|Secondary|Number of Participants With a Major Clinical Response (Continuous ACR70) for at Least 24 Weeks|"Efficacy endpoint: number of participants with a major clinical response defined as a continuous ACR70 from Baseline (Day 1) for at least 24 weeks.~ACR70 is a measure based on American College of Rheumatology criteria of at least a 70% improvement in the number of tender and swollen joints, and a 70% improvement in at least 3 of the following: the patient's global assessment of disease status; the patient's assessment of pain; the patient's assessment of function measured using the Stanford Health Assessment Questionnaire the physician's global assessment of disease status; serum C-reactive protein levels."|Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)|Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).|||participants||95% Confidence Interval|Number
2551319|NCT02819726|Secondary|Change From Baseline DAS28-erythrocyte Sedimentation Rate (ESR) at Weeks 8, 16, 24, 36 and 52|"Disease Activity Score 28- Erythrocyte Sedimentation Rate (DAS28-ESR) consisted of tender joint counts (TJC), swollen joint counts (SJC) & erythrocyte sedimentation rate (ESR). The formula is: [0.56*SQRT(tender 28 joint count)+0.28*SQRT(swollen 28 joint count)+0.7*ln(ESR)]+0.014*patient global health assessment.~Total DAS28-ESR scores are presented. Total scores range from 2 (minimum) to 10 (maximum). A lower score represents a better patient outcome. A DAS28-ESR of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission."|Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)|Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).|||score on a scale||Standard Deviation|Mean
2551320|NCT02819726|Secondary|Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: C-reactive Protein (CRP) Level|"C-reactive protein (CRP) level (Mg/L). CRP is a marker for inflammation. a normal reading is <3 Mg/L. Higher values indicate disease related inflammation and increased cardiovascular risk.~CRP levels between 3 Mg/L and 10 Mg/L are mildly elevated. Levels between 10 Mg/L and 100 Mg/L are moderately elevated and CRP levels above 100 Mg/L are severely elevated."|Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)|Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).|||Mg/L||Standard Deviation|Least Squares Mean
2551321|NCT02819726|Secondary|Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Assessment of Disability (Health Assessment Questionnaire-Disability Index [HAQ-DI])|"the Health Assessment Questionnaire-Disability Index (HAQ-DI) contains 20 questions split into 8 categories (dressing & grooming, arising, eating, walking, hygiene, reach, grip & activities). Scores were: 0 = Without ANY Difficulty; 1 = With SOME Difficulty; 2 = With MUCH Difficulty; 3 = UNABLE to Do. Total scores were calculated as the summed category scores divided by the number of categories.~Total HAQ-DI scores are presented which range from 0 to 3. Higher scores represent a worse outcome. Scores of 0 to 1 represent mild to moderate difficulty, 1 to 2 moderate disability, and 2 to 3 severe to very severe disability."|Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)|Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).|||score on a scale||Standard Deviation|Least Squares Mean
2551322|NCT02819726|Secondary|Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Global Assessment of Disease Activity (Assessed on 1 to 100 mm VAS)|Efficacy endpoint: Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants global assessment of disease activity (assessed on 1 to 100 mm visual analogue scale [VAS]). Patients rate how their Rheumatoid Arthritis has affected them, where 0 = very well and 100 = very poor.|Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)|Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).|||score on a scale||Standard Deviation|Least Squares Mean
2551323|NCT02819726|Secondary|Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Participants Assessment of Pain (Assessed on 1 to 100 mm Visual Analog Scale [VAS])|Participants assessment of pain (assessed on 1 to 100 mm Visual Analog Scale [VAS]). Participants assessment of pain (assessed on 1 to 100 mm Visual Analog Scale [VAS]) where 0 = no pain and 100 = severe pain.|Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)|Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).|||score on a scale||Standard Deviation|Least Squares Mean
2551324|NCT02819726|Secondary|Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Physicians Global Assessment of Disease Activity (Assessed on 1 to 100 mm Visual Analog Scale [VAS])|Efficacy endpoint: Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Physicians global assessment of disease activity (assessed on 1 to 100 mm Visual Analog Scale [VAS]). Where 0 = no disease activity and 100 = maximum disease activity.|Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)|Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).|||score on a scale||Standard Error|Least Squares Mean
2551345|NCT02819011|Secondary|Stride Velocity|stride velocity measured in single-task walking with normal speed|baseline, 6 months|Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data|||m/sec||Standard Deviation|Mean
2557470|NCT02709330|Secondary|Enrollment Rate|Rate of enrollment in reaching the 50 participants required to fill the trial.|Screening/baseline - Month 12||||participants per month|||Number
2551325|NCT02819726|Secondary|Individual Components of the ACR Improvement Criteria on Day 1 and at Weeks 8, 16, 24, 36 and 52: Swollen Joint Count (SJC) and Tender Joint Count (TJC) (the 66/68 Joint Count System)|Efficacy endpoint: Individual components of the ACR improvement criteria on Day 1 and at weeks 8, 16, 24, 36 and 52: Swollen Joint Count (SJC) and tender joint count (TJC) (the 66/68 joint count system). SJC and TJC assess the level of skeletal disease involvement. The 66/68 Joint Count evaluates 66 joints for swelling and 68 joints for tenderness.|Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)|Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).|||Joints||Standard Deviation|Least Squares Mean
2551326|NCT02819726|Secondary|American Collage of Rheumatology 50% Response Criteria (ACR50) Response Rates and American Collage of Rheumatology 70% Response Criteria (ACR70) at Weeks 8, 16, 24, 36 and 52|"Efficacy endpoint: American Collage of Rheumatology 50% response criteria (ACR50) response rates and American Collage of Rheumatology 70% response criteria (ACR70) at weeks 8, 16, 24, 36 and 52.~An ACR50 response is defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [Health Assessment Questionnaire (HAQ)], visual analogue pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).~An ACR70 response is defined as both improvement of 70% in the number of tender and number of swollen joints, and a 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [Health Assessment Questionnaire (HAQ)], visual analogue pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP)."|Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)|Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).|||participants||95% Confidence Interval|Number
2551327|NCT02819726|Secondary|American Collage of Rheumatology 20% Response Criteria (ACR20) Response Rates at Weeks 8, 16, 24, 36 and 52|"American Collage of Rheumatology (ACR) 20% response criteria (ACR20) response rates were assessed at Baseline and Weeks 8, 16, 24, 36 and 52.~An ACR20 response is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [Health Assessment Questionnaire (HAQ)], visual analogue pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP)."|Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)|Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).|||participants||95% Confidence Interval|Number
2551328|NCT02819726|Secondary|Change From Baseline in DAS28-CRP at Weeks 8, 16, 36 and 52|"Disease Activity Score 28-C-Reactive Protein (DAS28-CRP) samples taken at Baseline and Weeks 8, 16, 24, 36 and 52. DAS28-CRP was calculated using the following equation: [0.56*Square Root (SQRT) (tender 28 joint count)+0.28*SQRT(swollen 28 joint count)+0.36*ln(CRP+1)]*1.10+1.15.~Total DAS28-CRP scores are presented and range from 2.0 (minimum) to 10 (maximum). Lower scores represent a better patient outcome. Disease remission is considered achieved if the score is between 0 and <2.6. Low disease activity corresponds to 2.6 to <3.2. Moderate activity is between 3.2 & ≤5.1, while high activity is above 5.1."|Baseline and Weeks 8, 16, 24, 36 and 52 (EOS)|Full Analysis Set (analyses are reported in terms of the arm that the patient was initially randomised into. In the Rituxan arm only, patients eligible for treatment in Part B underwent a second randomisation to receive either Rituxan or SAIT101 and are reported in the Rituxan arm according to their initial randomisation).|||score on a scale||Standard Deviation|Mean
2551329|NCT02819726|Secondary|Terminal Half-life (T1/2)|Pharmacokinetic endpoint: Terminal half-life determined as ln2/λz.|Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.|Pharmacokinetic Analysis Set. T1/2 could not be determined for 1 participant in the SAIT101 arm, 2 participants in the MabThera arm and 1 participant in the Rituxan arm as either the terminal was undetermined or the Regulatory Scientific Quality was <0.800.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2551330|NCT02819726|Secondary|Volume of Distribution (VD)|Pharmacokinetic endpoint: Volume of distribution (VD) over the first dosing period calculated as dose (first + second dose) divided by [λz AUC(0-∞)]|Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.|Pharmacokinetic Analysis Set. VD could not be determined for 1 participant in the SAIT101 arm, 2 participants in the MabThera arm and 2 participants in the Rituxan arm as either the terminal phase was undetermined or the Regulatory Scientific Quality was <0.800.|||Litres (L)||Geometric Coefficient of Variation|Geometric Mean
2551331|NCT02819726|Secondary|Systemic Clearance (CL)|Pharmacokinetic endpoint: Systemic clearance (CL) over the first dosing period calculated as dose (first + second dose) divided by AUC(0-∞).|Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.|Pharmacokinetic Analysis Set. CL could not be determined for 1 participant in the SAIT101 arm, 2 participants in the MabThera arm and 2 participants in the Rituxan arm as either the terminal phase was undetermined or the Regulatory Scientific Quality (RSQ) was <0.800.|||L/day||Geometric Coefficient of Variation|Geometric Mean
2551332|NCT02819726|Secondary|Apparent Terminal Rate Constant (λz)|Pharmacokinetic endpoint: Apparent terminal rate constant (λz) determined by linear regression of the terminal points of the log-linear concentration-time curve. Best fit method followed by visual assessment was used to identify the terminal linear phase of the concentration-time profile. A minimum of 3 data points was used for determination.|Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.|Pharmacokinetic Analysis Set. λz could not be determined for 1 participant in the SAIT101 arm, 2 participants in the MabThera arm and 1 participant in the Rituxan arm as either the terminal phase was undetermined or the Regulatory Scientific Quality (RSQ) was <0.800.|||1/hr||Standard Deviation|Mean
2551334|NCT02819726|Secondary|Time to Maximum Plasma Concentration (Tmax) (Dose 1)|Pharmacokinetic endpoint: Maximum plasma concentration over the first dosing interval obtained directly from the observed concentration versus time data.|Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.|Pharmacokinetic Analysis Set. Tmax (dose 1) could not be determined for 1 participant in the SAIT101 arm, 1 patient in the MabThera arm and 2 participants in the Rituxan arm as samples were missing or set to missing due to initial or embedded Below the Limit of Quantification (BLQ)..|||Hours||Inter-Quartile Range|Median
2551335|NCT02819726|Secondary|Area Under the Concentration Time Curve Day 0 to Week 12 (AUC(0-w12))|Pharmacokinetic endpoint: Area under the concentration time curve Day 0 to Week 12 calculated by linear up/log down trapezoidal summation.|Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8 and 12. Unscheduled visit samples were taken at the discretion of the investigator.|Pharmacokinetic Analysis Set. AUC0-w12 could not be determined for 1 participant in the SAIT101 arm, 4 participants in the MabThera arm and 1 participant in the Rituxan arm because samples were missing|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2551336|NCT02819726|Secondary|Area Under the Concentration Time Curve Week 2 to Week 24 (AUC(w2-24)|Pharmacokinetic endpoint: Area under the concentration time curve week 2 to week 24 (AUC(w2-24) calculated by linear up/log down trapezoidal summation.|Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.|Pharmacokinetic Analysis Set. AUC0-w24 could not be determined for 30 participants in the SAIT101 arm, 32 participants in the MabThera arm and 28 participants either in the Rituxan arm as either there was no concentration at the start and/or end time, the Week 24 sample was out of window or samples were missing.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2551337|NCT02819726|Primary|Change From Baseline in DAS28-CRP at Week 24|"Disease Activity Score 28 C-reactive protein score (DAS28-CRP) at Week 24 (Full Analysis Set). CRP samples were collected at Baseline and Weeks 8, 16 and 24. DAS28-CRP was calculated using the following equation: [0.56*Square Root (SQRT) (tender 28 joint count)+0.28*SQRT(swollen 28 joint count)+0.36*ln(CRP+1)]*1.10+1.15.~Total DAS28-CRP scores were calculates and range from 2.0 (minimum) to 10 (maximum). Lower scores represent a better patient outcome. Disease remission is considered achieved if the score is between 0 and <2.6. Low disease activity corresponds to 2.6 to <3.2. Moderate activity is between 3.2 & ≤5.1, while high activity is above 5.1."|Baseline and Week 24|Full Analysis Set|||Score on a scale||Standard Deviation|Mean
2551338|NCT02819726|Primary|Trough Concentration (Ctrough) Before the Second Infusion on Day 15|Pharmacokinetic endpoint: Trough concentration (Ctrough) before the second infusion on Day 15 (Dose 2). Trough (pre-dose) concentration prior to second infusion on Day 15 obtained directly from the observed concentration versus time data.|Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1 and 2 (Pre-dose 2). Unscheduled visit samples were taken at the discretion of the investigator.|Pharmacokinetic Analysis Set. Ctrough could not be determined for 11 participants in the SAIT101 arm, 12 participants in the MabThera arm and 16 participants in the Rituxan arm as samples were collected outside of a 312 to 360 hour window.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2551339|NCT02819726|Primary|Peak Plasma Concentration (Cmax) After Day 15 Infusion|Pharmacokinetic endpoint: Maximum Plasma Concentration (Cmax) after Day 15 infusion (Dose 2)|Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1 and 2 (Pre-dose 2). Unscheduled visit samples were taken at the discretion of the investigator.|Pharmacokinetic Analysis Set.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2551340|NCT02819726|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC0-D15)|Pharmacokinetic endpoint: Area Under the Concentration verses time from time 0 to Day 15 prior to infusion (AUC0-D15) calculated by linear up/log down trapezoidal summation. Actual time/concentration on Day 15 was used for the calculation of this parameter unless the parameter was derived by interpolation.|Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.|Pharmacokinetic Analysis Set. AUC0-D15 could not be determined for 3 participants in the SAIT101 arm, 5 participants in the MabThera arm and 10 participants in the Rituxan arm as either the 336-hours blood sample was collected <312 hours or samples were missing.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2551341|NCT02819726|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC0-∞)|Pharmacokinetic endpoint: Area Under the Plasma Concentration from time 0 to infinity (AUC0-∞ (infinity). Calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the elimination rate constant: AUC(0-last) + C(last)/λz.|Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.|Pharmacokinetic Analysis Set. AUC0-∞ could not be calculated for 1 participant in the SAIT101 arm, 2 participants in the MabThera arm and 2 participants in the Rituxan arm as either the terminal phase was undetermined, the samples were missing or the Regulatory Scientific Quality (RSQ) was <0.800.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2551342|NCT02819726|Primary|Area Under the Concentration Time Cure From Time 0 to Last Quantifiable Concentration (AUC0-t)|Pharmacokinetic endpoint: Area under the concentration-time curve from time 0 (immediately predose on Day 1) to last quantifiable concentration (AUC0-t). Geometric means by treatment (Pharmacokinetic Analysis Set).|Samples for pharmacokinetic evaluation were taken at Baseline and Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24. Unscheduled visit samples were taken at the discretion of the investigator.|Pharmacokinetic Analysis Set. (AUC(0-t) could not be determined for 15 participants in the SAIT101 arm, 23 participants in the MabThera arm and 17 in the Rituxan arm as the Week 24 sample was either collected post-dose (i.e. not evaluable), was out of the collection window or was missing.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2551343|NCT02819011|Secondary|Stride Length|stride length measured in single-task walking with normal speed|baseline, 6 months|Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data|||meters||Standard Deviation|Mean
2551344|NCT02819011|Secondary|Stride Time|stride time measured in single task walking with normal speed|baseline, 6 months|Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data|||seconds||Standard Deviation|Mean
2551346|NCT02819011|Secondary|Percentage of Participants Who Found the Device Useful and Easy to Use|"The participants perceived usefulness of ease of use of wearing Moore Balance Brace (MBB) Ankle-Foot Orthosis (AFO) based on questionnaires of A technology acceptance model (TAM). Perceived usefulness was assessed using two questions (i.e., I feel more stable when standing, and I feel more stable when walking). Perceived ease of use was assessed using two questions (i.e., Was easy to take on and off, and Was comfortable to wear). The Likert scale (6-point scale from 0-5) was used to quantify how much they disagreed with each statement, including strongly disagree, disagree, somewhat disagree, somewhat agree, agree, and strongly agree, respectively. In this paper, responses were only categorized as positive (3-5 points) or negative (0-2 points) attitudes towards the use of AFO plus walking shoes."|6 months||||percentage of participants|||Number
2551347|NCT02819011|Secondary|Number of Participants With Adverse Events|Number of participants with adverse events reported during the study. Adverse events was inquired at 1 months, 3 months, 6 months, 12 months after the baseline, and summed at 12 months. If the participant has at least one adverse event reported in any assessed time frame, the participant will be categorized as the participant with adverse event.|assessed at 1, 3, 6, and 12 months, month 12 reported||||Participants|||Count of Participants
2551348|NCT02819011|Secondary|Physical Activity Level|Physical activity level for 24 hours while wearing their own shoes compared to the walking shoes and compared to walking shoes plus Ankle-Foot Orthosis (AFO). To quantify physical activity, number of taken steps per day was monitored using a pendant wearable sensor called, PAMSys (Biosensics, MA, USA).|baseline to 6 months|Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data|||number of steps per day||Standard Deviation|Mean
2551349|NCT02819011|Secondary|Concern for Falling Change Form Baseline to 6 Months|Concern for falling is quantified by Falls Efficacy Scale - International (FES-I) questionnaire. Scores range from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling). Higher score indicate worse performance.|Baseline, 6 months|Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data|||score on a scale||Standard Deviation|Mean
2551350|NCT02819011|Secondary|Fall Incidents|Fall incidents during the study|Baseline, 12 months|Some participants in AFO and No AFO groups withdrew from study in 6 and 12 months. Generalized Estimating Equation Analysis can handle such missing data|||falls per year precedent||Standard Deviation|Mean
2551351|NCT02819011|Secondary|Adherence (Hours Per Day to Wear Ankle-Foot Orthosis (AFO))|"The adherence of participants to the prescribed Ankle-Foot Orthosis (AFO) plus walking shoes was quantified using the response to a self-reported question (How many hours per day did you wear the prescribed footwear?)."|6 months||||hours per day||Standard Deviation|Mean
2551352|NCT02819011|Primary|Center of Mass (COM) Sway Change Baseline to 6 Months|Center of Mass (COM) sway measured by wearable inertial sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO)|baseline to 6 months|Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data|||cm^2||Standard Deviation|Mean
2551353|NCT02819011|Primary|Ankle Sway Change From Baseline to 6 Months|Ankle sway (motion of ankle joint in three dimensions) measured by wearable inertial sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO)|baseline to 6 months|Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data|||degree^2||Standard Deviation|Mean
2551354|NCT02819011|Primary|Hip Sway Change From Baseline to 6 Months|Hip sway (motion of hip joints in three dimensions) measured by wearable sensors while wearing their own shoes compared to the orthopedic shoes and compared to orthopedic shoes plus Ankle-Foot Orthosis (AFO)|baseline to 6 months|Some participants in AFO and No AFO groups withdrew from study in 6 months. Mixed Model Analysis can handle such missing data|||degree^2||Standard Deviation|Mean
2551355|NCT02818998|Secondary|Mean Change From Baseline in Vital Signs|Vital signs include body temperature, systolic and diastolic blood pressure, and heart rate.|Up to Week 100||2020-09-30|09/2020||||
2551356|NCT02818998|Secondary|Number of Participants With Treatment-emergent Adverse Event (TEAE)||Up to Week 100||2020-09-30|09/2020||||
2551357|NCT02818998|Secondary|Number of Participants With Categorized Changes From Baseline in Best Corrected Visual Acuity (BCVA)|Best Corrected Visual Acuity (BCVA) was measured in the study eye by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity. Number of participants with a ≥ 15 letter gain, a ≥ 10 letter gain, or a ≥ 30 letter loss in BCVA (ETDRS letters) at Week 52 were calculated.|From baseline to Week 100||2020-09-30|09/2020||||
2551358|NCT02818998|Secondary|Mean Change From Baseline in Central Retinal Thickness (CRT)|Central Retinal Thickness (CRT) was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).|From baseline to Week 100||2020-09-30|09/2020||||
2551359|NCT02818998|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)|Best Corrected Visual Acuity (BCVA) was measured in the study eye by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity.|From baseline to Week 100||2020-09-30|09/2020||||
2551360|NCT02818998|Secondary|Number of Participants With Categorized Changes From Baseline in Best Corrected Visual Acuity (BCVA)|Best Corrected Visual Acuity (BCVA) was measured in the study eye by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity. Number of participants with a ≥ 15 letter gain, a ≥ 10 letter gain, or a ≥ 30 letter loss in BCVA (ETDRS letters) at Week 52 were calculated.|From baseline to week 52|Full Analysis Set (FAS)|||Participants|||Count of Participants
2551361|NCT02818998|Secondary|Mean Change From Baseline in Central Retinal Thickness (CRT)|Central Retinal Thickness (CRT) was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).|From baseline to week 52|Participants in FAS taken into account for this analysis|||Microns||Standard Deviation|Mean
2551362|NCT02818998|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)|Best Corrected Visual Acuity (BCVA) was measured in the study eye by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score starting at 4 meters. The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity.|From baseline to Week 52|Full Analysis Set (FAS): included all randomized participants who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.|||Scores on a scale||Standard Deviation|Mean
2551363|NCT02818946|Primary|Negative Predictive Value|Negative Predictive Value of MRI in detecting breast cancer in women with pathologic nipple discharge. [Number of patients with negative MRIs / (Number of patients with negative MRIs + Number of patients with negative MRIs who present within 1 year with breast cancer)]|Day 1|Data not collected.||||||
2551364|NCT02818946|Primary|Positive Predictive Value|Positive Predictive Value of MRI in detecting breast cancer in women with pathologic nipple discharge. [Number of patients with positive MRIs confirmed with biopsy / (Number of patients with positive MRIs confirmed with biopsy + Number of patients with positive MRIs but with benign biopsy)]|Day 1|Data not collected.||||||
2551365|NCT02818946|Primary|Specificity|Specificity of MRI in detecting breast cancer in women with pathologic nipple discharge. [Number of patients with negative MRIs / (Number of patients with negative MRIs + Number of patients with positive MRIs but with benign biopsy)]|Day 1|Data not collected.||||||
2551366|NCT02818946|Primary|Sensitivity|Sensitivity of MRI in detecting breast cancer in women with pathologic nipple discharge. [Number of patients with positive MRIs confirmed with biopsy / (Number of patients with positive MRIs confirmed with biopsy + Number of patients with negative MRIs who present within 1 year with breast cancer)]|Day 1|Data not collected.||||||
2551367|NCT02818920|Other Pre-specified|Patterns of Metastases as Measured by Frequency at Site.|The Kaplan-Meier estimator will be used to estimate median DFS and its confidence interval. The frequencies of metastases by site will be tabulated|Until disease recurrence or death (up to 5 years)]|||||||
2551368|NCT02818920|Other Pre-specified|Correlation of Pathologic Response to the Quantity of TILs|A Wilcoxon rank sum test will be used to test the association of the quantity of TILs and pathologic response to neoadjuvant therapy.|At surgery (days 29-56)|||||||
2551369|NCT02818920|Other Pre-specified|Correlation of Pathologic Response to the Quality of TILs|A Fisher exact test will be used to evaluate the association of the quality of TILs with pathologic tumor response to neoadjuvant therapy.|At surgery (day 29-56)|||||||
2551370|NCT02818920|Other Pre-specified|Correlation of Pathologic Response to the Presence of TILs|A Fisher exact test will be used to evaluate the association of the presence of TILs with pathologic tumor response to neoadjuvant therapy.|At surgery (day 29-56)|||||||
2551371|NCT02818920|Other Pre-specified|Gene Expression of the PD-1/PD-L1 Axis|Elucidate genes associated with function and modulation of the PD-1/PD-L1 axis.|End of protocol treatment ((Estimated at 10.5 months from start depending on treatment components received by patient)|||||||
2551372|NCT02818920|Other Pre-specified|Detectability of Circulating T Cells Meeting New Definition of Detectability|Percentage of patients with circulating T cells meeting the new definition of detectable.|End of protocol treatment ((Estimated at 10.5 months from start depending on treatment components received by patient)|||||||
2551373|NCT02818920|Other Pre-specified|Change in Immunomodulatory Effects|Determine if the immunomodulatory effects of neoadjuvant pembrolizumab have an impact on the suppressive mechanisms, restoring functional reactivity to important anti-tumor effects cell populations. Functional TAA-specific T cell reactivities will measured at 4 time points.|Baseline (day 0), before surgery (days 29-56), 3-6 weeks after surgery, and after completion of adjuvant pembrolizumab (estimated at 10.5 months from start depending on treatment components received by patient)|||||||
2551374|NCT02818920|Other Pre-specified|Pathologic Response Rate|Pathologic response rate for neoadjuvant pembrolizumab|At surgery (day 29-56)|||||||
2551375|NCT02818920|Other Pre-specified|Detectability of Circulating T Cells Specific Against TAA|Proportion of patients with detectable circulating T cells specific against TAA after protocol treatment.|End of protocol treatment (estimated at 10.5 months from start depending on treatment components received by patient)|||||||
2551376|NCT02818920|Other Pre-specified|Adverse Events|Safety will be evaluated for all treated patients using CTCAE V 4.0.|End of protocol treatment (estimated at 10.5 months from start depending on treatment components received by patient)|||||||
2551377|NCT02818920|Other Pre-specified|Detectability of Tumor Infiltrating Lymphocytes (TILs)|Percentage of patients with detectable TILs, defined as greater than or equal to 0.05% (with each value also being at least twice that of the background unstimulated control value TIL)|End of protocol treatment (Estimated at 10.5 months from start depending on treatment components received by patient)|||||||
2551378|NCT02818920|Other Pre-specified|Change in Blood-based Biomarker Values|Changes in levels of blood-based biomarkers before and after protocol treatment and correlated with clinical outcomes, such as objective response, overall survival, and disease-free survival.|Baseline (day 0), before surgery (days 29-56), 3-6 weeks after surgery, and after completion of adjuvant pembrolizumab (estimated at 10.5 months from start depending on treatment components received by patient)|||||||
2551379|NCT02818920|Other Pre-specified|Disease-free Survival (DFS)|DFS is defined as the time from surgical resection to disease recurrence (first disease recurrence or death, whichever comes first) after surgery.The Kaplan-Meier estimator will be used to estimate median DFS and its confidence interval.|Until disease recurrence or death (up to 5 years)|||||||
2551380|NCT02818920|Other Pre-specified|Objective Response Rate|The percentage of patients having a complete response or a partial response to protocol treatment. Objective response will be measured by RECIST 1.1.|At the end of 2 cycles of neoadjuvant pembrolizumab (29-55 days after initiation)|||||||
2551381|NCT02818920|Primary|Surgical Feasibility Rate as Measured by the Number of Subjects Who Undergo Surgery Following Neoadjuvant Pembrozulimab|A patient who meets the eligibility criteria, has received at least 1 dose of pembrolizumab, and undergone surgery in the window of 29-56 days after initiation of pembrolizumab is considered surgically feasible. All other situations are considered infeasible.|29-56 days after initiation of pembrolizumab|Subjects who completed surgery.|||Participants|||Count of Participants
2551382|NCT02818777|Secondary|Change in MDS-UPDRS Tremor Score (Total of Items 3.17 and 3.18) in the ON State|Sum of items 3.17 and 3.18 of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) evaluates the rest tremor amplitude (3.17, score range 0-20) and constancy of rest tremor (3.18 score range 0-4). The sum scores of 3.17 and 3.18 range 0-24. Higher values represent a worse outcome.|Baseline and 5 weeks|10 Participants completed the study drug treatment and were included in the efficacy analysis group.|||score on a scale||Standard Deviation|Mean
2551383|NCT02818777|Primary|Change in Unified Dyskinesia Rating Scale (UDysRS)|To evaluate involuntary movements often associated with treated Parkinson's disease. Total UDysRS scores is the sum of historical sub-scores (0-60) and objective sub-score (0-44). Total scores range 0-104. Higher values represent a worse outcome.|Baseline and 5 weeks|10 Participants completed the study drug treatment and were included in the efficacy analysis group.|||score on a scale||Standard Deviation|Mean
2551384|NCT02818777|Primary|Change in International Restless Legs Syndrome Study Group Rating Scale for Restless|This encompasses a ten-question instrument for measuring severity of restless legs syndrome (RLS). Score range 0-40. Higher values represent a worse outcome.|Baseline and 5 weeks|10 Participants completed the study drug treatment and were included in the efficacy analysis group.|||score on a scale||Standard Deviation|Mean
2551385|NCT02818777|Primary|Change in Fatigue Severity Scale|A self-report 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity. Scores range 9-63. Higher values represent a worse outcome.|Baseline and 5 weeks|10 Participants completed the study drug treatment and were included in the efficacy analysis group.|||score on a scale||Standard Deviation|Mean
2551386|NCT02818777|Primary|Change in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS)|To measure severity of symptoms and support a diagnosis of impulse control disorders and related disorders in PD. Total QUIP-RS scores were summed by 6 subscores (gambling 0-16, Sex 0-16, Buying 0-16, Eating 0-16, Hobbyism-punding 0-32, and PD Medication use 0-16), range 0-112. Higher scores represent a worse outcome.|Baseline and 5 weeks|10 Participants completed the study drug treatment and were included in the efficacy analysis group.|||score on a scale||Standard Deviation|Mean
2551387|NCT02818777|Primary|Change in Pain Severity Form|This will assess severity of pain. Scores range 3-15. Higher scores represent a worse outcome.|Baseline and 5 weeks|10 Participants completed the study drug treatment and were included in the efficacy analysis group.|||score on a scale||Standard Deviation|Mean
2551388|NCT02818777|Primary|Change in Emotional and Behavioral Dyscontrol Short Form|8 items that assess severity of emotional and behavioral dyscontrol. Scores range 8-40. Higher values represent a worse outcome.|Baseline and 5 weeks|10 Participants completed the study drug treatment and were included in the efficacy analysis group.|||score on a scale||Standard Deviation|Mean
2551389|NCT02818777|Primary|Change From Baseline of REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)|"10-item, patient self-rating instrument assessing the subject's sleep behavior with short questions that have to be answered by either yes or no. Scores range 0-13. Higher values represent a worse outcome."|Baseline and 5 weeks|10 Participants completed the study drug treatment and were included in the efficacy analysis group.|||score on a scale||Standard Deviation|Mean
2551390|NCT02818777|Primary|Change in Scales for Outcomes in Parkinson's Disease (SCOPA)-Sleep-night Time Sleep|A valid, reliable, short scale that is used to evaluate night time sleep problems in PD. Scores range 0-18. Higher values represent a worse outcome.|Baseline and 5 weeks|10 Participants completed the study drug treatment and were included in the efficacy analysis group.|||score on a scale||Standard Deviation|Mean
2551391|NCT02818777|Primary|Change in Depression Short Form|This includes 8 items that assess severity of depression. Score range 8-40. Higher values represent a worse outcome.|Baseline and 5 weeks|10 Participants completed the study drug treatment and were included in the efficacy analysis group.|||score on a scale||Standard Deviation|Mean
2551392|NCT02818777|Primary|Change in Neuropsychiatric Inventory (NPI)|Assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer's disease and other neurodegenerative disorders. It has proven to be sensitive to change and has been employed to capture treatment related behavioral.Total NPI scores range 0-120. Higher values represent a worse outcome.|Baseline and 5 weeks||||score on a scale||Standard Deviation|Mean
2551393|NCT02818777|Primary|Change in Anxiety Short Form|This includes 8 items that assess severity of anxiety. Scores range 8-40. Higher values represent a worse outcome.|Baseline and 5 weeks|10 participants completed the study drug treatment and were included in efficacy analysis group.|||score on a scale||Standard Deviation|Mean
2551394|NCT02818777|Primary|Change in Montreal Cognitive Assessment (MoCA)|MoCA - is designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visual -constructional skills, conceptual thinking, calculation. Scores range 0-30. Higher values represent a better outcome.|Baseline and 5 weeks|10 Participants completed the study drug treatment and were included in efficacy analysis group.|||score on a scale||Standard Deviation|Mean
2551395|NCT02818777|Primary|Change in Movement Disorder Society-Unified Parkinsons Disease Rating Scale Total Score|There are four parts: Part I (Non-motor experiences of daily living, scores range 0-52), Part II (motor experiences of daily living, scores range 0-52), Part III (motor examination, scores range 0-132) and Part IV (motor complications scores range 0-24). Subscales are summed to a total score, ranging 0-260. Higher scores mean a worse outcome.|Baseline and 5 weeks|10 Participants completed the study drug treatment and were included in the efficacy analysis group.|||score on a scale||Standard Deviation|Mean
2551396|NCT02818777|Primary|Proportion of Subjects That Drop Out of the Study Due to Study Drug Intolerance|Assessing the proportion of subjects that drop out of the study due to study drug intolerance.|Baseline and 5 weeks||||Participants|||Count of Participants
2551397|NCT02818777|Primary|Number of Participants Had Changes in Laboratory Values|Laboratory tests (hematology, serum chemistry, and urinalysis) will be evaluated at each study visit.|Baseline and 5 weeks||||Participants|||Count of Participants
2551398|NCT02818777|Primary|Number of Participants Had Changes in EKG|EKG will be performed at each study visit.|Baseline and 5 weeks||||Participants|||Count of Participants
2551399|NCT02818777|Primary|Number of Participants Had Changes in Physical Exam|A physical exam will be performed at each study visit.|Baseline and 5 weeks||||Participants|||Count of Participants
2551401|NCT02818777|Primary|Severity of Participants Reporting Study-related Adverse Events at Each Dose Level|Severity of each specific adverse event was scored as 0=no adverse event, 1=mild adverse event, 2=moderate adverse event, and 3=sever adverse event. The range of severity is 0-3. Higher scores mean a worse outcome. The severity was expressed as mean (standard deviation).|Every 3rd day on each dose level, assessed up to 5 weeks|13 PD patients were included in safety analysis group because they were all treated with study drug.|||units on a scale||Standard Deviation|Mean
2551402|NCT02818569|Secondary|Subjective Sleep Quality (Phase II)|Self-reported sleep latency.|Active study night, visit 3 or 4||||minutes||Standard Deviation|Mean
2551403|NCT02818569|Secondary|Performance on the Motor Sequence Task (Phase II)|Number of participants with improved MST score after sleeping.|Active study night, visit 3 or 4||||Participants|||Count of Participants
2551404|NCT02818569|Secondary|Performance on the Psychomotor Vigilance Task (Phase II)|The number of responses that were longer than 400 milliseconds (lapse 400).|Active study night, visit 3 or 4||||lapses||Standard Deviation|Mean
2551405|NCT02818569|Primary|Polysomnography Sleep Quality (Phase II).|Number of participants who had EEG features of natural sleep. Relative quantities of spindles and k-complexes were used to assess approximation to natural sleep.|Active study night, visit 3 or 4|All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.|||participants|||Number
2551406|NCT02818569|Primary|Hemodynamic Stability (Phase I)|Number of participants with (1) systolic blood pressure (SBP) < 60 mmHg, diastolic blood pressure (DBP) < 40 mmHg or decrease of SBP by ≥ 50 % from the baseline which is sustained over two consecutive minutes, (2) hypertension: SBP > 180 mmHg, DBP > 100 mmHg, or increase of SBP by ≥ 50 % from the baseline which is sustained over two minutes and, (3) bradycardia: heart rate (HR) < 40 bpm or decrease by ≥ 50 % from the baseline sustained over two consecutive minutes.|Active study night, visit 3 or 4||||Participants|||Count of Participants
2551407|NCT02818244|Primary|Primary Outcome Measure: Heart Rate Monitor Accuracy Compared to ECG Expressed as Correlation Coefficient.|The primary outcome measure is the accuracy of each heart rate monitor compared to ECG. This will be expressed by the correlation coefficient and will also be depicted by Bland-Altman plots.|24 minutes||||Concordance Correlation Coefficient wECG||95% Confidence Interval|Mean
2551408|NCT02818114|Primary|Posttraumatic Stress Disorder (PTSD) Checklist-5|Self-report measure of PTSD symptoms; score range is 0-80, with higher scores indicating more PTSD symptoms.|10 weeks||||score on a scale||Standard Deviation|Mean
2551409|NCT02818114|Primary|PE Sessions Attended|Number of PE Sessions attended during 10 weeks of participation in study. 10 is the maximum, 0 is the minimum. Higher numbers of sessions attended are an indication of better engagement in treatment.|10 weeks||||number of PE sessions attended||Standard Deviation|Mean
2551410|NCT02818036|Primary|Self-reported Feelings of Connection in Response to the Scanner Tasks|"feelings of social connection in response to reading sentences from known people (i.e. average of how connected, touched, warm did you feel). Feelings were reported on a scale of 1 (not at all) to 7 (very) such that higher numbers reflect greater feelings of social connection.~time frame was mistakenly entered as the start of the fMRI scan, but participants reported on their feelings of social connection after the scan. Thus, the outcome measure time frame is reported as two, rather than one, hour after taking the study drug."|approximately two hours after taking study drug|All participants. Ratings from 1 participant in the naltrexone group were misplaced. 1 participant from the sugar pill group did not follow instructions and so ratings were not included in final analyses.|||scores on a scale||Standard Deviation|Mean
2551411|NCT02818036|Primary|Bold Oxygen-level Dependent (BOLD) Activations in Prespecified ROIs|In the MRI scanner, participants read sentences written by people they knew and people they did not know in a block design. Brain activity was measured as BOLD activity in response to reading sentences from known (vs. unknown) people using functional magnetic resonance imaging (FMRI). Based on a priori hypotheses, brain activity was masked to activity in structural regions-of-interest (ROIs) of the ventral striatum (VS) and middle-insula (MI).|approximately one hour after taking study drug|all participants, 3 excluded from sugar pill group (1 for poor registration during preprocessing, 1 for technical error with task presentation, 1 for signal dropout in primary regions of interest)|||BOLD signal||Standard Error|Mean
2551412|NCT02817841|Secondary|Change From Baseline to End of Treatment in the Score of the Menstrual Distress Questionnaire (MDQ)|The MDQ is a standard method for measuring cyclical perimenstrual symptoms. The participants rated common symptoms and feelings associated with menstruation using the following scale: 0 (no experience of symptom), 1 (present, mild), 2 (present, moderate), 3 (present, strong),and 4 (present, severe) observed during pre-menstrual (4 days before menstruation), menstrual (most recent flow) and intermenstrual (remainder of the cycle) phases. Reported values are values at Cycle 13 minus values at Baseline. An overall positive change from baseline represents an increase in symptom or feeling severity.|Baseline and end of treatment (Cycle 13 with 1 cycle = 28 days)|Participants aged 16 to 50 years, inclusive, at screening with both baseline and end of treatment (EOT) MDQ results|||units on a scale||Standard Deviation|Mean
2551413|NCT02817841|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Results at Baseline and End of Treatment - Satisfaction With Medicine and Overall Life Satisfaction and Contentment Over the Past Week|"The Q-LES-Q-SF is a self-report measure designed to assess the degree of enjoyment and satisfaction in daily functioning. Participants were asked to rate 16 different items on a 5-point scale where score 1 = very poor and score 5 = very good. The last two items - item 15 rating satisfaction with medicine and item 16 rating overall life satisfaction over the past week are two global items that are scored individually. For both items, a higher score is associated with a better outcome."|Baseline and end of treatment (Cycle 13 with 1 cycle = 28 days)|Participants aged 16 to 50 years, inclusive, at screening with baseline and end of treatment (EOT) Q-LES-Q-SF results.|||Units on a scale||Standard Deviation|Mean
2551427|NCT02817841|Secondary|Number of Subjects With Unscheduled Bleeding/Spotting Episodes|Unscheduled bleeding/spotting is defined as any bleeding/spotting that occurs while taking active hormones that does not meet the criteria for scheduled bleeding.|Up to 11 months (12 cycles with 1 cycle = 28 days)|Participants aged 16 to 50 years, inclusive, at screening, with evaluable cycle data for the bleeding analysis.|||Participants|||Count of Participants
2551414|NCT02817841|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Results at Baseline and End of Treatment - Percentage Maximum (Sum of First 14 Items)|The Q-LES-Q-SF is a self-report measure designed to assess the degree of enjoyment and satisfaction in daily functioning. Participants were asked to rate 16 different items on a 5-point scale where score 1 = very poor and score 5 = very good. A raw total score is calculated by summing the first 14 items and ranges from 14 to 70. The raw total score is then transformed into a percentage maximum score using the following formula: (raw total score-minimum score)/(maximum possible raw score-minimum score). The minimum raw is 14 and maximum raw score is 70. Thus the formula for % maximum score can be written as (raw score -14)/56. A higher percentage maximum score indicates a higher life enjoyment and satisfaction.|Baseline and end of treatment (Cycle 13 with 1 cycle = 28 days)|Participants aged 16 to 50 years, inclusive, at screening with baseline and end of treatment (EOT) Q-LES-Q-SF results.|||Percentage maximum score on a scale||Standard Deviation|Mean
2551415|NCT02817841|Secondary|Number of Participants With Clinically Abnormal Gynecological Examination Results|"Gynecological examinations included breast examination (performed by palpation) and assessment of the adnexa, cervix, uterus, vagina, and external genitalia.~When reporting the results, the use of the Abnormal category was reserved for findings that were considered clinically significant, in the opinion of the Investigator; the Normal category included Abnormal results that were not clinically significant, as well as no findings."|Baseline and end of treatment (Cycle 13 with 1 cycle = 28 days)|Participants aged 16 to 50 years, inclusive, at screening, who received at least one dose of investigational product with baseline and end of treatment (EOT) data.|||Participants|||Count of Participants
2551416|NCT02817841|Secondary|Number of Participants With Clinically Abnormal Physical Examination Results|"Physical examinations included an evaluation of body as a whole, skin, head, eyes, ears, nose, and throat, neck, cardiovascular, respiratory, musculoskeletal, neurologic, lymphatic/thyroid, abdomen. When reporting the results of the physical examination, the use of the Abnormal category was reserved for findings that were considered clinically significant, in the opinion of the Investigator; the Normal category included Abnormal results that were not clinically significant, as well as no findings."|Baseline and end of treatment (Cycle 13 with 1 cycle = 28 days)|Participants aged 16 to 50 years, inclusive, at screening, who received at least one dose of investigational product with baseline and end of treatment (EOT) data.|||Participants|||Count of Participants
2551417|NCT02817841|Secondary|Number of Subjects With Clinically Abnormal Vital Signs|Vital signs included sitting systolic and diastolic blood pressures, and heart rate. All abnormal findings in vital signs that were considered by the Investigator to be clinically significant were recorded as adverse events.|Up to 12 months (13 cycles with 1 cycle = 28 days)|Participants aged 16 to 50 years, inclusive, at screening, who received at least one dose of investigational product.|||Participants|||Count of Participants
2551418|NCT02817841|Secondary|Number of Participants With Clinically Significant out-of Range Serum Chemistry and Lipid Profile Results||Up to 12 months (13 cycles with 1 cycle = 28 days)|Participants aged 16 to 50 years, inclusive, at screening, who received at least one dose of investigational product.|||Participants|||Count of Participants
2551419|NCT02817841|Secondary|Number of Participants With Clinically Significant out-of Range Hematology Results||Up to 12 months (13 cycles with 1 cycle = 28 days)|Participants aged 16 to 50 years, inclusive, at screening, who received at least one dose of investigational product.|||Participants|||Count of Participants
2551420|NCT02817841|Secondary|Number of Subjects With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability.|A treatment-emergent adverse event (TEAE) was defined as any AE not present prior to the initiation of the treatment or any event already present that worsened in either intensity or frequency following exposure to the treatment. Since the starting point for adverse event (AE) collection was the signing of the informed consent, not the start of the investigational product, the AEs recorded prior to first investigational product administration were designated as AEs while those that occurred or worsened after the initiation of the investigational product were designated as TEAEs.|Up to 12 months (13 cycles with 1 cycle = 28 days)|Participants aged 16 to 50 years, inclusive, at screening who received at least one dose of investigational product.|||Participants|||Count of Participants
2551421|NCT02817841|Secondary|Mean Number of Bleeding and Spotting Days by Reference Period|Bleeding data were analysed by 91-day reference period (RP). There were 4 RPs: Reference Period 1 = Day 1 to Day 91; Reference Period 2 = Day 92 to Day 182; Reference Period 3 = Day 183 to Day 273; and Reference Period 4 = Day 274 to Day 364.|up to 12 months (13 cycles)|Participants aged 16 to 50 years, inclusive, at screening, with evaluable cycle data for the bleeding analysis.|||Days||Standard Deviation|Mean
2551422|NCT02817841|Secondary|Number of Subjects With Bleeding and/or Spotting Episodes by Reference Period|Bleeding data were analysed by 91-day reference period. There were 4 RPs: Reference Period 1 = Day 1 to Day 91; Reference Period 2 = Day 92 to Day 182; Reference Period 3 = Day 183 to Day 273; and Reference Period 4 = Day 274 to Day 364.|Up to 12 months (13 cycles with 1 cycle = 28 days)|Participants aged 16 to 50 years, inclusive, at screening, with evaluable reference period for the bleeding analysis.|||Participants|||Count of Participants
2551423|NCT02817841|Secondary|Number of Scheduled Bleeding and/or Spotting Days Per Cycle|Scheduled bleeding/spotting is defined as any bleeding/spotting that occurs during the hormone-free interval (i.e. Days 25 - 28) and continues through Days 1-3 of the subsequent active cycle.|Up to 11 months (12 cycles with 1 cycle = 28 days)|Participants aged 16 to 50 years, inclusive, at screening, with evaluable cycle data for the bleeding analysis.|||Days||Standard Deviation|Mean
2551424|NCT02817841|Secondary|Number of Subjects With Absence of Scheduled Bleeding and/or Spotting|Scheduled bleeding/spotting is defined as any bleeding/spotting that occurs during the hormone-free interval (i.e. Days 25 - 28) and continues through Days 1-3 of the subsequent active cycle.|Up to 11 months (12 cycles with 1 cycle = 28 days)|Participants aged 16 to 50 years, inclusive, at screening, with evaluable cycle data for the bleeding analysis|||Participants|||Count of Participants
2551425|NCT02817841|Secondary|Number of Unscheduled Spotting Days Per Cycle|Unscheduled spotting is defined as any spotting that occurs while taking active hormones that does not meet the criteria for scheduled bleeding and/or spotting.|Up to 11 months (12 cycles with 1 cycle = 28 days)|Participants aged 16 to 50 years, inclusive, at screening, with evaluable cycle data for the bleeding analysis.|||Days||Standard Deviation|Mean
2551470|NCT02817555|Secondary|Hemoglobin|median hemoglobin (g/L) over 12 months|12 months||||g/L||Inter-Quartile Range|Median
2551428|NCT02817841|Secondary|Rate of Pregnancy (Life-table Analysis) in Participants Aged 16 to 50 Years|"The life-table analysis evaluates the cumulative probability of pregnancy over 13 cycles. Cumulative Rate and 95% confidence interval (CI) are from Kaplan-Meier estimation. Only on-treatment pregnancies are included.~On-treatment pregnancy is a pregnancy with an estimated date of conception after the date of the first dose of study medication to 7 days after the last dose of study medication (regardless of whether the last dose is an active or inactive tablet) inclusive."|Up to 12 months (13 cycles with 1 cycle = 28 days)|Participants aged 16 to 50 years, inclusive, at screening, who received at least one dose of investigational product|||percentage of participants||95% Confidence Interval|Number
2551429|NCT02817841|Secondary|Rate of Pregnancy (Life-table Analysis) in Participants Aged 16 to 35 Years|"The life-table analysis evaluates the cumulative probability of pregnancy over 13 cycles. Cumulative Rate and 95% CI are from Kaplan-Meier estimation. Only on-treatment pregnancies are included.~On-treatment pregnancy is a pregnancy with an estimated date of conception after the date of the first dose of study medication to 7 days after the last dose of study medication (regardless of whether the last dose is an active or inactive tablet) inclusive."|Up to 12 months (13 cycles with 1 cycle = 28 days)|Participants aged 16 to 35 years, inclusive, at screening, who received at least one dose of investigational product|||percentage of participants||95% Confidence Interval|Number
2551430|NCT02817841|Secondary|The Number of On-treatment Pregnancies as Assessed by the Method Failure Pearl Index in the Overall Study Population (16-50 Years)|"On-treatment pregnancies are pregnancies with an estimated date of conception within the in-treatment period i.e. Day 1 to 7 days after the last intake of investigational product (whether active or inactive tablet). The method failure Pearl Index, defined as the number of pregnancies as a result of method failure per 100 women-years of treatment, was calculated as follow: (1300*number of on-treatment pregnancies as a result of method failure)/number of women 28-day equivalent cycles of treatment. Pregnancies due to user failure were excluded from the numerator. User failure pregnancies were pregnancies that occurred when the subject did not take the investigational product correctly.~At-risk-cycle was defined as cycle in which no other methods of birth control (including condoms and emergency contraception) were used by the subject and during which the subject confirmed that sexual intercourse had occurred."|Up to 12 months (13 cycles with 1 cycle = 28 days)|Participants aged 18 to 50 years, inclusive, at screening with at least 1 cycle included in the denominator.|||Method failure Pearl Index||95% Confidence Interval|Number
2551431|NCT02817841|Secondary|The Number of On-treatment Pregnancies (With + 7-day Window) Per 100 Woman-years of Exposure (Pearl Index) in the Overall Study Population (16-50 Years)|"On-treatment pregnancies are pregnancies with an estimated date of conception within the in-treatment period i.e. Day 1 to 7 days after the last intake of investigational product (whether active or inactive tablet). The Pearl Index, defined as the number of pregnancies per 100 women-years of treatment was calculated as: Pearl Index = (1300*number of on-treatment pregnancies)/number of women 28-day equivalent cycles of treatment. Only at-risk cycles were included in the denominator of the Pearl Index calculation, unless a conception occurred during a cycle.~At-risk-cycle was defined as cycle in which no other methods of birth control (including condoms and emergency contraception) were used by the subject as confirmed in the subject diary and during which the subject confirmed that sexual intercourse had occurred."|Up to 12 months (13 cycles with 1 cycle = 28 days)|Participants aged 16 to 50 years, inclusive, at screening with at least 1 cycle included in the denominator.|||Pearl Index||95% Confidence Interval|Number
2551432|NCT02817841|Secondary|The Number of On-treatment Pregnancies (With +7-day Window) as Assessed by the Method Failure Pearl Index in Subjects Aged 16 to 35 Years, Inclusive, at the Time of Screening|"On-treatment pregnancies are pregnancies with an estimated date of conception within the in-treatment period i.e. Day 1 to 7 days after the last intake of investigational product (whether active or inactive tablet). The method failure Pearl Index, defined as the number of pregnancies as a result of method failure per 100 women-years of treatment, was calculated as follow: (1300*number of on-treatment pregnancies as a result of method failure)/number of women 28-day equivalent cycles of treatment. Pregnancies due to user failure were excluded from the numerator. User failure pregnancies were pregnancies that occurred when the subject did not take the investigational product correctly.~At-risk-cycle was defined as cycle in which no other methods of birth control (including condoms and emergency contraception) were used by the subject and during which the subject confirmed that sexual intercourse had occurred."|Up to 12 months (13 cycles with 1 cycle = 28 days)|Participants aged 16 to 35 years, inclusive, at screening with at least 1 cycle included in the denominator.|||Method failure Pearl Index||95% Confidence Interval|Number
2551433|NCT02817841|Primary|The Number of On-treatment Pregnancies (With + 7-day Window) Per 100 Woman-years of Exposure (Pearl Index) in Subjects Aged 16 to 35 Years, Inclusive, at the Time of Screening|"On-treatment pregnancies are pregnancies with an estimated date of conception within the in-treatment period i.e. Day 1 to 7 days after the last intake of investigational product (whether active or inactive tablet). The Pearl Index, defined as the number of pregnancies per 100 women-years of treatment was calculated as: Pearl Index = (1300*number of on-treatment pregnancies)/number of women 28-day equivalent cycles of treatment. Only at-risk cycles were included in the denominator of the Pearl Index calculation, unless a conception occurred during a cycle.~At-risk-cycle was defined as cycle in which no other methods of birth control (including condoms and emergency contraception) were used by the subject as confirmed in the subject diary and during which the subject confirmed that sexual intercourse had occurred."|Up to 12 months (13 cycles with 1 cycle = 28 days)|Participants aged 16 to 35 years, inclusive, at screening with at least 1 cycle included in the denominator.|||Pearl Index||95% Confidence Interval|Number
2551434|NCT02817828|Secondary|Change From Baseline to End of Treatment in the Score of the Menstrual Distress Questionnaire (MDQ)|"The MDQ is a standard method for measuring cyclical perimenstrual symptoms. The participants rated common symptoms and feelings associated with menstruation using the following scale: 0 (no experience of symptom), 1 (present, mild), 2 (present, moderate), 3 (present, strong),and 4 (present, severe) observed during pre-menstrual (4 days before menstruation), menstrual (most recent flow) and intermenstrual (remainder of the cycle) phases.~Reported values are values at Cycle 13 minus values at Baseline. An overall positive change from baseline represents an increase in symptom or feeling severity."|Baseline and Cycle 13 (1 cycle = 28 days)|Participants aged 18 to 50 years, inclusive, at screening with both baseline and end of treatment MDQ results.|||units on a scale||Standard Deviation|Mean
2551471|NCT02817555|Primary|Cost of Erythropoiesis Stimulating Agent|total cost over 12 months in Canadian dollars|12 months||||dollars Canadian||Inter-Quartile Range|Median
2551435|NCT02817828|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Results at Baseline and End of Treatment - Satisfaction With Medicine and Overall Life Satisfaction Over the Past Week|"The Q-LES-Q-SF is a self-report measure designed to assess the degree of enjoyment and satisfaction in daily functioning. Participants were asked to rate 16 different items on a 5-point scale where score 1 = very poor and score 5 = very good.~A raw total score is calculated by summing the first 14 items and ranges from 14 to 70 with a higher scores indicating higher life enjoyment and satisfaction. The raw total score is then transformed into a percentage maximum score using the following formula: (raw total score-minimum score)/(maximum possible raw score-minimum score).~In addition, the last two items (15 and 16) are two global items that are scored individually. These items rate satisfaction with medicine and overall life satisfaction over the past week."|Baseline and Cycle 13 (1 cycle = 28 days)|Participants aged 18 to 50 years, inclusive, at screening with baseline and end of treatment Q-LES-Q-SF results.|||Units on a scale||Standard Deviation|Mean
2551436|NCT02817828|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Results at Baseline and End of Treatment - Percentage Maximum (Sum of First 14 Items)|"The Q-LES-Q-SF is a self-report measure designed to assess the degree of enjoyment and satisfaction in daily functioning. Participants were asked to rate 16 different items on a 5-point scale where score 1 = very poor and score 5 = very good.~A raw total score is calculated by summing the first 14 items and ranges from 14 to 70 with a higher scores indicating higher life enjoyment and satisfaction. The raw total score is then transformed into a percentage maximum score using the following formula: (raw total score-minimum score)/(maximum possible raw score-minimum score).~In addition, the last two items (15 and 16) are two global items that are scored individually. These items rate satisfaction with medicine and overall life satisfaction over the past week."|Baseline and Cycle 13 (1 cycle = 28 days)|Participants aged 18 to 50 years, inclusive, at screening with baseline and end of treatment Q-LES-Q-SF results.|||Percentage maximum score on a scale||Standard Deviation|Mean
2551437|NCT02817828|Secondary|Endometrial Biopsy Histology at Screening and End of Treatment|Endometrial biopsies was obtained from a subset of subjects included in the endometrial safety substudy at the screening visit and at the end of treatment visit if the subject has completed at least 10 cycles.|Baseline and end of treatment (up to 13 cycles with 1 cycle = 28 days)|Participants aged 18 to 50 years, inclusive, at screening with an evaluable endometrial biopsies both at screening and end of treatment.|||Participants|||Count of Participants
2551438|NCT02817828|Secondary|Number of Subjects With Abnormal Gynecological Examination Results|"Gynecological examinations included breast examination (performed by palpation) and assessment of the adnexa, cervix, uterus, vagina, and external genitalia.~When reporting the results, the use of the Abnormal category was reserved for findings that were considered clinically significant, in the opinion of the Investigator; the Normal category included Abnormal results that were not clinically significant, as well as no findings."|From screening to end of treatment (12 months)|Participants aged 18 to 50 years, inclusive, at screening, who received at least one dose of investigational product with baseline and end of treatment (EOT) gynecological results.|||Participants|||Count of Participants
2551439|NCT02817828|Secondary|Number of Subjects With Abnormal Physical Examination Results|"Physical examinations included an evaluation of body as a whole, skin, head, eyes, ears, nose, and throat, neck, cardiovascular, respiratory, musculoskeletal, neurologic, lymphatic/thyroid, abdomen.~When reporting the results of the physical examination, the use of the Abnormal category was reserved for findings that were considered clinically significant, in the opinion of the Investigator; the Normal category included Abnormal results that were not clinically significant, as well as no findings."|From screening to end of treatment (12 months)|Participants aged 18 to 50 years, inclusive, at screening, who received at least one dose of investigational product with baseline and end of treatment (EOT) results.|||Participants|||Count of Participants
2551440|NCT02817828|Secondary|Number of Subjects With Abnormal Laboratory Assessment Results|Laboratory assessment included blood hematology, biochemistry, and lipids|From screening to end of treatment (12 months)|Participants aged 18 to 50 years, inclusive, at screening, who received at least one dose of investigational product.|||Participants|||Count of Participants
2551441|NCT02817828|Secondary|Number of Subjects With Abnormal Vital Signs|Vital signs included sitting systolic and diastolic blood pressures, and heart rate.|From screening to end of treatment (12 months)|Participants aged 18 to 50 years, inclusive, at screening, who received at least one dose of investigational product.|||Participants|||Count of Participants
2551442|NCT02817828|Secondary|Number of Scheduled Bleeding and/or Spotting Days Per Cycle|Scheduled bleeding and /or spotting is defined as any bleeding and/or spotting that occurs during the hormone-free interval (i.e. Days 25 - 28) and continues through Days 1-3 of the subsequent active cycle.|Up to 11 months (12 cycles with 1 cycle = 28 days)|Participants aged 18 to 50 years, inclusive, at screening, with evaluable cycle data for the bleeding analysis.|||Days||Standard Deviation|Mean
2551443|NCT02817828|Secondary|Number of Subjects With Absence of Scheduled Bleeding and/or Spotting|Scheduled bleeding/spotting is defined as any bleeding/spotting that occurs during the hormone-free interval (i.e. Days 25 - 28) and continues through Days 1-3 of the subsequent active cycle.|Up to 11 months (12 cycles with 1 cycle = 28 days)|Participants aged 18 to 50 years, inclusive, at screening, with evaluable cycle data for the bleeding analysis.|||Participants|||Count of Participants
2551444|NCT02817828|Secondary|Number of Unscheduled Spotting Days Per Cycle|Unscheduled spotting is defined as any spotting that occurs while taking active hormones that does not meet the criteria for scheduled bleeding and/or spotting.|Up to 11 months (12 cycles with 1 cycle = 28 days)|Participants aged 18 to 50 years, inclusive, at screening, with evaluable cycle data for the bleeding analysis.|||Days||Standard Deviation|Mean
2551445|NCT02817828|Secondary|Number of Unscheduled Bleeding Days Per Cycle|Unscheduled bleeding is defined as any bleeding that occurs while taking active hormones that does not meet the criteria for scheduled bleeding and/or spotting.|Up to 11 months (12 cycles with 1 cycle = 28 days)|Participants aged 18 to 50 years, inclusive, at screening, with evaluable cycle data for the bleeding analysis.|||Days||Standard Deviation|Mean
2551446|NCT02817828|Secondary|Number of Subjects With Unscheduled Bleeding/Spotting|Unscheduled bleeding/spotting is defined as any bleeding/spotting that occurs while taking active hormones that does not meet the criteria for scheduled bleeding.|Up to 11 months (12 cycles with 1 cycle = 28 days)|Participants aged 18 to 50 years, inclusive, at screening, with evaluable cycle data for the bleeding analysis.|||Participants|||Count of Participants
2551447|NCT02817828|Secondary|The Number of On-Treatment Pregnancies as Assessed by the Method Failure Pearl Index in the Overall Study Population (18-50 Years)|On-treatment pregnancies are defined as pregnancies with an estimated date of conception within the in-treatment period i.e. Day 1 to 2 days after the last intake of investigational product (whether active or inactive tablet). The Pearl Index, defined as the number of pregnancies per 100 women-years of treatment was calculated as: Pearl Index = (1300*number of on-treatment pregnancies)/number of women 28-day equivalent cycles of treatment. The method failure Pearl Index includes only those pregnancies that were classified as method failure and not the pregnancies due to user failure, i.e. incorrect intake of the contraceptive method. Only at-risk cycles were included in the denominator of the Pearl Index calculation. At-risk-cycles were defined as cycles in which no other methods of birth control (including condoms) were used by the subject as confirmed in the subject diary and during which the subject confirmed that sexual intercourse had occurred.|Up to 12 months (13 cycles with 1 cycle = 28 days)|Participants aged 18 to 50 years, inclusive, at screening with at least 1 cycle included in the denominator.|||Method Failure Pearl Index||95% Confidence Interval|Number
2551448|NCT02817828|Secondary|The Number of On-treatment Pregnancies (With + 2-day Window) Per 100 Woman-years of Exposure (Pearl Index) in the Overall Study Population (18-50 Years)|"On-treatment pregnancies are defined as pregnancies with an estimated date of conception within the in-treatment period i.e. Day 1 to 2 days after the last intake of investigational product (whether active or inactive tablet). The Pearl Index, defined as the number of pregnancies per 100 women-years of treatment was calculated as: Pearl Index = (1300*number of on-treatment pregnancies)/number of women 28-day equivalent cycles of treatment.Only at-risk cycles were included in the denominator of the Pearl Index calculation.~At-risk-cycles were defined as cycles in which no other methods of birth control (including condoms) were used by the subject as confirmed in the subject diary and during which the subject confirmed that sexual intercourse had occurred."|Up to 12 months (13 cycles with 1 cycle = 28 days)|Participants aged 18 to 50 years, inclusive, at screening with at least 1 cycle included in the denominator.|||Pearl Index||95% Confidence Interval|Number
2551449|NCT02817828|Secondary|The Number of On-treatment Pregnancies (With 2-day Window) as Assessed by the Method Failure Pearl Index in Subjects Aged 18 to 35 Years, Inclusive, at the Time of Screening|On-treatment pregnancies are defined as pregnancies with an estimated date of conception within the in-treatment period i.e. Day 1 to 2 days after the last intake of investigational product (whether active or inactive tablet). The Pearl Index, defined as the number of pregnancies per 100 women-years of treatment was calculated as: Pearl Index = (1300*number of on-treatment pregnancies)/number of women 28-day equivalent cycles of treatment. The method failure Pearl Index includes only those pregnancies that were classified as method failure and not the pregnancies due to user failure, i.e. incorrect intake of the contraceptive method. Only at-risk cycles were included in the denominator of the Pearl Index calculation. At-risk-cycles were defined as cycles in which no other methods of birth control (including condoms) were used by the subject as confirmed in the subject diary and during which the subject confirmed that sexual intercourse had occurred.|Up to 12 months (13 cycles with 1 cycle = 28 days)|Participants aged 18 to 35 years, inclusive, at screening with at least 1 cycle included in the denominator.|||Method failure Pearl Index||95% Confidence Interval|Number
2551450|NCT02817828|Primary|The Number of On-treatment Pregnancies (With + 2-day Window) Per 100 Woman-years of Exposure (Pearl Index) in Subjects Aged 18 to 35 Years, Inclusive, at the Time of Screening|"On-treatment pregnancies are defined as pregnancies with an estimated date of conception within the in-treatment period i.e. Day 1 to 2 days after the last intake of investigational product (whether active or inactive tablet). The Pearl Index, defined as the number of pregnancies per 100 women-years of treatment was calculated as: Pearl Index = (1300*number of on-treatment pregnancies)/number of women 28-day equivalent cycles of treatment.Only at-risk cycles were included in the denominator of the Pearl Index calculation.~At-risk-cycles were defined as cycles in which no other methods of birth control (including condoms) were used by the subject as confirmed in the subject diary and during which the subject confirmed that sexual intercourse had occurred."|Up to 12 months (13 cycles with 1 cycle = 28 days)|Participants aged 18 to 35 years, inclusive, at screening with at least 1 cycle included in the denominator.|||Pearl Index||95% Confidence Interval|Number
2551451|NCT02817763|Secondary|Modified Root Coverage Esthetic Score (MRES)|The MRES evaluated six variables: gingival margin (GM): 0 or 3 points; marginal tissue contour (MTC): 0 or 1 point; soft tissue texture (STT): 0 or 1 point; mucogingival junction alignment (MGJ): 0 or 1 point; gingival color (GC): 0 or 1 point; restoration/cervical lesion color (R/CLC): 0 points = color of restoration or uncovered cervical lesion does not match with tooth's color; 3 points = good color integration. Thus, 10 points was a perfect score.|6 months||||units on a scale|photographs|Standard Deviation|Mean
2551452|NCT02817763|Primary|Percentage of Defect Coverage|Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.|6 months||||Gingival recessions|Gingival recessions||Count of Units
2551453|NCT02817594|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism|"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Absenteeism indicates the percentage of work time missed due to health problems."|Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|The Core Population who were employed and with available data at baseline and each time point.|||percent impairment||Inter-Quartile Range|Median
2551454|NCT02817594|Secondary|Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score|"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status with a separate visual analog scale (VAS).~The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable)."|Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|The Core Population with available data at baseline and each time point.|||units on a scale||Inter-Quartile Range|Median
2551488|NCT02816710|Secondary|Reabsorption Time of Blood|To monitor the reabsorption time of preretinal blood.|follow up period, up to an average of 6 months after the operation||||days||Standard Deviation|Mean
2551455|NCT02817594|Secondary|Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score|"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS).~Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status."|Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|The Core Population with available data at baseline and each time point.|||units on a scale||Inter-Quartile Range|Median
2551456|NCT02817594|Secondary|Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies||From first dose of study drug through 30 days after last dose (16 weeks).|The Safety Population, defined as all enrolled participants who received at least one dose of the ABBVIE regimen.|||Participants|||Count of Participants
2551457|NCT02817594|Secondary|Percentage of Ribavirin (RBV) Treatment Days in Relation to the Target Number of Ribavirin Treatment Days||From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.|The Core Population who were prescribed ribavirin.|||percentage of days||Standard Deviation|Mean
2551458|NCT02817594|Secondary|Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin|"Adherence to study treatment was calculated as:~Cumulative dose taken / (initial prescribed dose * planned duration)"|From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen|The Core Population who were prescribed ribavirin.|||Participants|||Count of Participants
2551459|NCT02817594|Secondary|Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA|"Adherence to study treatment was calculated as:~Cumulative dose taken / (initial prescribed dose * planned duration)"|From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.|The Core Population|||Participants|||Count of Participants
2551460|NCT02817594|Secondary|Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment|"SVR12 non-response was categorized according to the following:~On-treatment virologic failure (breakthrough [at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥ 50 IU/mL]);~Relapse, defined as HCV RNA < 50 IU/mL at EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened);~Premature treatment discontinuation with no on-treatment virologic failure;~Missing SVR12 data and/or none of the above criteria."|12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)|The Core Population|||Participants|||Count of Participants
2551461|NCT02817594|Secondary|Percentage of Participants With Breakthrough|Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.|12 or 24 weeks (depending on the treatment regimen)|The Core Population with virological response on-treatment and with at least one on-treatment measurement thereafter (including EOT).|||percentage of participants||95% Confidence Interval|Number
2551462|NCT02817594|Secondary|Percentage of Participants With Relapse|Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.|End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.|The Core Population with VR at EOT and who completed treatment, and had ≥ 1 HCV RNA measurement ≥ 70 days post-treatment or were a treatment failure between EOT and day 70.|||percentage of participants||95% Confidence Interval|Number
2551463|NCT02817594|Secondary|Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment|"Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.~The Core Population with sufficient follow-up data regarding SVR12 included all core population participants who~had evaluable HCV RNA data ≥ 70 days after the last actual dose of the ABBVIE REGIMEN~or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline~or had HCV RNA < 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure."|12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)|The Core Population with sufficient follow-up data regarding SVR12|||percentage of participants||95% Confidence Interval|Number
2551464|NCT02817594|Secondary|Percentage of Participants Achieving Virological Response at End of Treatment|Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.|End of treatment (week 12 or 24 depending on the treatment regimen)|The Core Population defined as enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants||95% Confidence Interval|Number
2551465|NCT02817594|Primary|Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)|Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure.|12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)|The Core Population, defined as enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants||95% Confidence Interval|Number
2551466|NCT02817555|Secondary|Iron Cost|total iron cost over 12 months in Canadian dollars|12 months||||canadian dollars||Inter-Quartile Range|Median
2551467|NCT02817555|Secondary|Iron Dose|median weekly iron dose (mg) over 12 months|12 months||||mg/week||Inter-Quartile Range|Median
2551468|NCT02817555|Secondary|Transferrin Saturation (TSAT)|median TSAT (%) over 12 months|12 months||||percentage saturation||Inter-Quartile Range|Median
2551469|NCT02817555|Secondary|Ferritin|mean ferritin (ug/L) over 12 months|12 months||||ug/L||Standard Deviation|Mean
2551472|NCT02817516|Secondary|AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-828F||Cohorts 1 and 2: Days 1 and 7 pre-dose and at multiple time points (up to 24 hours) post-dose and Day 14 pre-dose and at multiple time points (up to 72 hours) post-dose; Cohort 3: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|PK set included all participants who received at least 1 dose of study drug, had at least 1 measurable plasma/urine concentration of TAK-828F. PK set where data at specified time points was available. PK data was not collected for Day 7 and 14 Part 1 Cohort 3, as participants received last dose on Day 6 due to study termination.|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Geometric Mean
2551473|NCT02817516|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-828F||Days 1 and 7 pre-dose and at multiple time points (up to 24 hours) post-dose and Day 14 pre-dose and at multiple time points (up to 72 hours) post-dose|PK set included all participants who received at least 1 dose of study drug, had at least 1 measurable plasma/urine concentration of TAK-828F. PK set where data at specified time points was available. PK data was not collected for Day 7 and 14 Part 1 Cohort 3, as participants received last dose on Day 6 due to study termination.|||hours||Full Range|Median
2551474|NCT02817516|Secondary|Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-828 (TAK-828F)||Days 1 and 7 pre-dose and at multiple time points (up to 24 hours) post-dose and Day 14 pre-dose and at multiple time points (up to 72 hours) post-dose|Pharmacokinetic (PK) set included all participants who received at least 1 dose of study drug, had at least 1 measurable plasma/urine concentration of TAK-828F. PK set where data at specified time points was available. PK data was not collected for Day 7 and 14 Part 1 Cohort 3, as participants received last dose on Day 6 due to study termination.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2551475|NCT02817516|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) at Least Once Post-dose||Baseline up to 10 days after last dose of study drug (Day 24)|The safety set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2551476|NCT02817516|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose||Baseline up to 10 days after last dose of study drug (Day 24)|The safety set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2551477|NCT02817516|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose||Baseline up to 10 days after last dose of study drug (Day 24)|The safety set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2551478|NCT02817516|Primary|Percentage of Participants Who Discontinued the Treatment Due to an Adverse Event (AE)||Baseline up to 10 days after last dose of study drug (Day 24)|The safety set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2551479|NCT02817516|Primary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)||Baseline up to 10 days after last dose of study drug (Day 24)|The safety set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2551480|NCT02816723|Secondary|Repeatable Battery for Neuropsychological Status (RBANS) Total Scaled Change Score|Participants' scores on the Repeatable Battery for Neuropsychological Status (RBANS) were collected within 2 weeks before the intervention and again within 2 weeks after the intervention. The maximum total scaled score is 160, and the minimum score is 40, where higher scores are better. This outcome measure represents the change in total scaled score on the RBANS: post-intervention score minus pre-intervention score. A higher change score for a particular arm indicates a greater degree of improvement.|Baseline (within two weeks pre-intervention) and Outcome at 2 months (within 2 weeks post-intervention)||||units on a scale||Standard Deviation|Mean
2551481|NCT02816723|Primary|State-Trait Anxiety Inventory (STAI) Change Score|Participants' scores on the State-Trait Anxiety Inventory (STAI) were collected within 2 weeks before the intervention and again within 2 weeks after the intervention. This outcome measure represents the change in score in State-Trait Anxiety Inventory: pre-intervention score minus post-intervention score. The maximum STAI score is 80, and the minimum score is 20. Higher scores on the STAI indicate more anxiety symptoms, so worse outcome. However, since we are analyzing a change in the STAI score of pre- minus post-intervention, a larger change score for a particular arm indicates a greater degree of improvement.|Baseline (within two weeks pre-intervention) and Outcome at 2 months (within 2 weeks post-intervention)||||units on a scale||Standard Deviation|Mean
2551482|NCT02816723|Primary|Geriatric Depression Scale Change Score|Participants' scores on the Geriatric Depression Scale were collected within 2 weeks before the intervention and again within 2 weeks after the intervention. This outcome measure represents the change in score in Geriatric Depression Scale: pre-intervention score minus post-intervention score. The maximum Geriatric Depression Scale score is 30, and the minimum score is 0. Higher scores on the Geriatric Depression Scale indicate more depressive symptoms, so worse outcome. However, since we are analyzing a change in the Geriatric Depression Scale score of pre- minus post-intervention, a larger change score for a particular arm indicates a greater degree of improvement.|Baseline (within two weeks pre-intervention) and Outcome at 2 months (within 2 weeks post-intervention)||||score on a scale||Standard Deviation|Mean
2551483|NCT02816710|Secondary|Need for Reoperation|due to recurrent retinal detachment or unclear vitreous hemorrhage|follow up period, up to an average of 6 months after the operation||||Participants|||Count of Participants
2551484|NCT02816710|Secondary|Recurrent Retinal Detachment||follow up period, up to an average of 6 months after the operation||||Participants|||Count of Participants
2551485|NCT02816710|Secondary|Number of Participants With Neovascular Glaucoma (NVG)||follow up period, up to an average of 6 months after the operation||||Participants|||Count of Participants
2551486|NCT02816710|Secondary|Frequency of Intraoperative Electrocoagulation|The number of times electrocoagulation, which was used to stop bleeding, was carefully counted.|during the operation time||||events||Standard Deviation|Mean
2551487|NCT02816710|Secondary|Recurrent Vitreous Hemorrhage|Recurrent vitreous hemorrhage(VH) was referred to any new episode of VH occurring after one week postoperatively, dividing into early stage (≤ 4 weeks) and late stage (> 4 weeks).|follow up period, up to an average of 6 months after the operation||||Participants|||Count of Participants
2551489|NCT02816710|Secondary|Postoperative Preretinal Blood|The grading criteria for postoperative preretinal blood: Grade 1, isolated blood clots within 10 disk area but without covering the posterior pole; Grade 2, broad blood clots exceeding 10 disk area regardless of involvement of the posterior pole; Grade 3, broad blood clots exceeding 10 disk area as well as involving the posterior pole. Maximal extent of preretinal blood within 1 week postoperatively was used for grading the extent of hemorrhage.|postoperatively, up to 1 week||||Participants|||Count of Participants
2551490|NCT02816710|Primary|Intraoperative Bleeding|The grading criteria for intraoperative bleeding: Grade 1, spontaneous cessation of minor bleeding or bleeding that stopped by transient elevation of perfusion pressure; Grade 2, moderate bleeding requiring endodiathermy or broad blood clots formed far away from the bleeding site; Grade 3, thick blood clots exceeding half of the posterior pole or affecting the operation field.|Time between the insertion and extraction of three 23-gauge vitrectomy ports||||Participants|||Count of Participants
2551491|NCT02816710|Primary|Duration of Surgery|To evaluate the influence of these three methods to the final duration of surgery. We carefully estimated the time of the vitrectomy from insertion to extraction of the 23-gauge three-port trocars.|during the operation time||||minutes||Standard Deviation|Mean
2551492|NCT02816710|Primary|Best-corrected Visual Acuity||6 months||||LogMAR||Standard Deviation|Mean
2551493|NCT02816346|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Invaplex Antigen|Blood (10 mL) was collected on days -1, 7, 14, 28 and 56 for Immunoglobulin A (IgA), Immunoglobulin M (IgM), and Immunoglobulin G (IgG) assay by Enzyme linked immunosorbent assay (ELISA).|57 days|No sample was available for one subject in Cohort 3 on Day 56.|||titer||Standard Deviation|Geometric Mean
2551494|NCT02816346|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Invaplex Antigen|Blood (10 mL) was collected on days -1, 7, 14, 28 and 56 for Immunoglobulin A (IgA), Immunoglobulin M (IgM), and Immunoglobulin G (IgG) assay by Enzyme linked immunosorbent assay (ELISA).|57 days|No sample was available for one subject in Cohort 3 on Day 56.|||titer||Standard Deviation|Geometric Mean
2551495|NCT02816346|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen|Blood (10 mL) was collected on days -1, 7, 14, 28 and 56 for Immunoglobulin A (IgA), Immunoglobulin M (IgM), and Immunoglobulin G (IgG) assay by Enzyme linked immunosorbent assay (ELISA).|57 days||||titer||Standard Deviation|Geometric Mean
2551496|NCT02816346|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin G (IgG) Antibodies in Serum: Lipopolysaccharide (LPS) Antigen|Blood (10 mL) was collected on days -1, 7, 14, 28 and 56 for Immunoglobulin A (IgA), Immunoglobulin M (IgM), and Immunoglobulin G (IgG) assay by Enzyme linked immunosorbent assay (ELISA).|57 days||||titer||Standard Deviation|Geometric Mean
2551497|NCT02816346|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Invaplex Antigen|IgA (total and S. sonnei specific) will be determined in fecal extracts using standard ELISA. IgA was recovered from stool samples using a soybean trypsin inhibitor-EDTA procedure. The shigella-antigen specific activity was calculated by dividing the endpoint titer by the IgA concentration in matched samples.|Baseline (days -5,-1), Day 3, Day 7, and Day 14|Stool samples were not collected from all subjects at all time points. Samples containing less than 2 ug/mL of total IgA were excluded from analysis. If both baseline samples were below 2 ug/mL, the subject was excluded from analysis.|||titer||Standard Deviation|Geometric Mean
2551498|NCT02816346|Secondary|Geometric Mean Titer (GMT) of Immunoglobulin A (IgA) Antibodies in Stool: Lipopolysaccharide (LPS) Antigen|IgA (total and S. sonnei specific) will be determined in fecal extracts using standard ELISA. IgA was recovered from stool samples using a soybean trypsin inhibitor ethylenediaminetetraacetic acid (EDTA) procedure. The shigella-antigen specific activity was calculated by dividing the endpoint titer by the IgA concentration in matched samples.|Baseline (days -5,-1), Day 3, Day 7, and Day 14|Stool samples were not collected from all subjects at all time points. Samples containing less than 2 ug/mL of total IgA were excluded from analysis. If both baseline samples were below 2 ug/mL, the subject was excluded from analysis.|||titer||Standard Deviation|Geometric Mean
2551499|NCT02816346|Primary|Number of Participants With Shigellosis|"Per protocol definition: shedding of S. sonnei in the stool accompanied by moderate-severe diarrhea (4 or more loose/watery Grade 3-5 stools or 400+ gram stools per 24 hours, or requires medical intervention) and/or dysentery (a Grade 3, 4, or 5 stool with gross blood on at least 2 occasions and reportable constitutional symptoms) along with moderate fever (Oral temperature of ≥101.2°F) or one or more severe intestinal symptoms.~Alternative endpoint 1 definition: severe diarrhea, or moderate diarrhea plus fever, or moderate diarrhea plus 1 moderate constitutional/enteric symptom, or dysentery.~Alternative endpoint 2 definition: severe diarrhea, or moderate diarrhea plus fever, or moderate diarrhea plus 1 severe constitutional/enteric symptom, or dysentery plus 1 severe constitutional/enteric symptom"|11 days after administration of S. sonnei||||Participants|||Count of Participants
2551500|NCT02816138|Secondary|Change in NYU (New York University) Paragraph Recall Performance|Secondary cognitive outcome of a neuropsychological test examining episodic memory performance using the NYU Paragraph Recall test. No absolute range. Higher scores indicate better performance.|Baseline to week 12|Subject who withdrew early not included due to no 12-week data.|||Items correct||Standard Error|Mean
2551501|NCT02816138|Secondary|Change in One-back Test Performance|"Secondary cognitive outcome examining change in speed of responses ton the one-back test, no absolute range. In this variant of the N-back task, participants view a series of cards, and indicate whether the card they are currently viewing is identical to the previously viewed card. Lower scores indicate better performance."|Baseline to week 12|Subject who withdrew early not included due to no 12-week data.|||milliseconds||Standard Deviation|Mean
2551502|NCT02816138|Secondary|Change in Choice Reaction Time (CRT) Performance|Secondary cognitive outcome, a neuropsychological test measure of attention. We examined the total response time for the CRT. Lower scores indicate better performance.|Baseline to week 12|Subject who withdrew early not included due to no 12-week data.|||milliseconds||Standard Error|Mean
2551503|NCT02816138|Secondary|Change in MFQ (Memory Frequency Questionnaire) Score|Secondary cognitive outcome: Change in subjective cognitive performance as measured by MFQ, a self-report scale ranging from 64-448. Higher scores indicate better subjective memory function, while lower scores indicate poorer subjective memory function.|Baseline to week 12|Subject who withdrew early not included due to no 12-week data.|||units on a scale||Standard Deviation|Mean
2551504|NCT02816138|Secondary|Change in Apathy Evaluation Scale (AES)|Secondary Mood Outcomes: Change in apathy as measured by the self-report AES, a questionnaire with a range of 0-54, where lower scores indicate greater apathy.|Baseline to 12 weeks|Subject who withdrew early not included due to no 12-week data.|||units on a scale||Standard Deviation|Mean
2551505|NCT02816138|Secondary|Change in Ruminative Response Scale Total Score|Secondary mood outcome: Change in rumination measured by the Ruminative Response Scale total score measured at baseline and week 12. This is a self-report scale with a range of 0-66, where higher scores indicate higher levels of rumination.|Baseline to week 12|Subject who withdrew early not included due to no 12-week data.|||units on a scale||Standard Deviation|Mean
2551506|NCT02816138|Secondary|Change in Penn State Worry Questionnaire (PSWQ)|Secondary mood outcome: Change in anxiety and worry measured by PSWQ, a self-report questionnaire with a range of 16-80, where higher scores indicate greater anxiety and worry.|Baseline to week 12|One participant not included due to early withdrawal.|||units on a scale||Standard Deviation|Mean
2551507|NCT02816138|Secondary|Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score|Secondary mood outcome: Change in anhedonia measured by SHAPS, a self-report questionnaire that ranges from 0-42, where higher scores indicate greater anhedonia.|Baseline to week 12|One subject not included due to early withdrawal|||units on a scale||Standard Deviation|Mean
2551508|NCT02816138|Primary|Change in Continuous Performance Task (CPT) Performance|"Primary cognitive outcome, the CPT is a neuropsychological test that measures attention. In this 14-minute test, participants are asked to respond when any letter appears, except the non-target letter X. This test is conducted at baseline and at week 12. The specific primary outcome metric is standard error of change in the inter-stimulus hit reaction time, or variability between different trials. There is no absolute range, but lower scores indicate decreased variability across trials and overall better performance."|Baseline to week 12|Subject who withdrew early not included due to no 12-week data.|||milliseconds||Standard Deviation|Mean
2551509|NCT02816138|Primary|Change in Total MADRS (Montgomery Asberg Depression Rating Scale) Score|Primary mood outcome measured by the total score of the clinician-rated MADRS. MADRS was measured every 3 weeks (baseline, week 3, week 6, week 9, and week 12). MADRS total score range is 0-60, where higher scores indicate greater depression severity.|Baseline to week 12|Analyses included all participants, including the one subject who withdrew early. Missing values were imputed using the mean value of the sample at that time point.|||units on a scale||Standard Deviation|Mean
2551510|NCT02815982|Secondary|Number of Daily Steps Averaged Over a Week for Caregivers -- CAREGIVER MEASURE|PCS and caregivers were trained to wear a piezoelectric, computer downloadable pedometer consecutively for 7 days prior to the pre- and post- intervention and 4 months post-intervention assessments to assess frequency of daily steps. The scale was measured as the continuous number of daily steps averaged over a week.|Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)||||Average number of steps per day||Standard Deviation|Mean
2551511|NCT02815982|Secondary|Parent Waist to Hip Ratio -- CAREGIVER MEASURE|Measured at the clinic via standardized equipment|Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)||||ratio||Standard Deviation|Mean
2551512|NCT02815982|Secondary|Parent BMI Score -- CAREGIVER MEASURE|Measured at the clinic via standardized equipment.|Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)||||kg/m^2||Standard Deviation|Mean
2551513|NCT02815982|Secondary|Child Waist to Hip Ratio -- ONLY Pediatric Cancer Survivors (PCS) ASSESSED|Measured at the clinic via standardized equipment.|Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)||||ratio||Standard Deviation|Mean
2551514|NCT02815982|Secondary|Number of Daily Steps Averaged Over a Week -- ONLY Pediatric Cancer Survivors (PCS) Assessed|PCS and caregivers were trained to wear a piezoelectric, computer downloadable pedometer consecutively for 7 days prior to the pre- and post- intervention and 4 months post-intervention assessments to assess frequency of daily steps. The scale was measured as the continuous number of daily steps averaged over a week.|Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)||||Average number of steps per day||Standard Deviation|Mean
2551515|NCT02815982|Secondary|Child Feeding Questionnaire Sum Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE|This 31-item questionnaire assesses parental approaches to and attitudes about feeding their children. Sub-scales include concerns about child weight, monitoring, restriction, and pressure to eat. The sum score of the Likert items ranged from 31 to 155 with higher scores indicating greater perceived concern, monitoring, restriction and pressure to eat.|Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)||||units on a scale||Standard Deviation|Mean
2551516|NCT02815982|Secondary|Child Sugar Sweet Beverage and Fast Food Intake Scale Sum Score -- ONLY Pediatric Cancer Survivors (PCS) Assessed on This Measure|This 8-item questionnaire was completed by the pediatric cancer survivor and assessed child intake of sugar sweetened beverages, breakfast and dinner habits, as well as frequency of fast food intake. The sum score represents the total number of sugary beverages consumed and the number of times consuming fast food in the prior week. Higher scores indicate greater consumption of sugary beverages and fast food in the prior week. The sum score could range from 0 and has no upper limit.|Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)||||units on a scale||Standard Deviation|Mean
2551517|NCT02815982|Secondary|Child BMI Percentile -- ONLY Pediatric Cancer Survivors (PCS)|Continuous child BMI percentile as a function of gender and age. This measure was obtained via the PCS medical chart.|Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)||||percentile||Standard Deviation|Mean
2551518|NCT02815982|Secondary|Automated Self-administered 24-Hour Dietary Recall (ASA 24) -- CAREGIVERS ONLY MEASURE|A 24-hour recall was completed by caregivers using the Automated Self-administered 24-Hour Dietary Recall-2011 (adult version) at pre-intervention, post-intervention (6-weeks) and at 4 months follow-up. The outcome was measured as the number of calories consumed over 1-day. Caregivers reported detailed information on the foods consumed and quantity including the method used for preparation, portion sizes, and where the food was purchased using visual cues in the previous day through the ASA24 website (https://asa24.nci.nih.gov/). The website reported the total number of calories consumed based on the data input.|Pre-Intervention, Post-Intervention (6-weeks), Follow-up (4 Months)||||calories||Standard Deviation|Mean
2551773|NCT02809183|Secondary|Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between Each TRC101 Dose Group Versus Placebo|Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for each TRC101 dose group versus that for Placebo|Baseline and Day 15|Full Analysis Set|||mEq/L||Standard Error|Least Squares Mean
2551519|NCT02815982|Primary|Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE|At the end of the final session (6-sessions), caregivers completed a likert-type survey assessing what they liked/disliked about the intervention, as well as what was/was not useful or helpful in reaching health goals. Eleven items were summed to obtain a total continuous composite satisfaction/liking score. Each item was measured on a likert scale ranging from strongly disagree (=1) to strongly agree (=5). The scale sum score ranged from 11 to 55 with higher scores indicating greater satisfaction with the intervention. More specifically, the higher the score, the more useful the caregiver thought the intervention and the more they liked participating in the intervention. Lower scores indicate that the caregiver thought the program was not useful and they did not like participating.|6 weeks|Independent Samples T-Test|||units on a scale||Standard Deviation|Mean
2551520|NCT02815735|Primary|Comfort During the Day|Comfort during the day for comfilcon A and lotrafilcon B lenses assessed via via SMS (short message service) text message at days 3,12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale 0-10, 0=painful, 10=can't feel the lenses.|Days 3, 12, 26|Missing data from one participant.|||units on a scale||Standard Deviation|Mean
2551521|NCT02815735|Primary|Comfort|Comfort (insertion, end of the day, and overall) for habitual lenses assessed at baseline and comfilcon A and lotrafilcon B lenses assessed at 2 weeks and 4 weeks. Scale 0-10, 0=painful, 10=can't feel the lenses.|Baseline, 2 weeks, 4 weeks||||units on a scale||Standard Deviation|Mean
2551522|NCT02815670|Secondary|Number of Participants Developing Treatment-emergent Antidrug Antibodies (ADA) With Cross Reactivity to Idarucizumab||At day 25 post vial 2 of Idarucizumab administration, up to 1 day|Treated set (TS): including all patients who received any dose of Idarucizumab. The TS was used to assess safety, clinical endpoints, demographics and baseline characteristics, concomitant diagnosis/therapy and medical history, as well as ADA.|||Participants|||Count of Participants
2551523|NCT02815670|Secondary|Number of Participants With Clinical Conditions Contributing to Bleeding During the Trial|Number of participants with clinical conditions (trauma, surgery and use of antiplatelet) contributing to bleeding during the trial were characterized.|From vial 1 of Idarucizumab until prematurely discontinued of the trial, up to 25 days|Treated set (TS): including all patients who received any dose of Idarucizumab. The TS was used to assess safety, clinical endpoints, demographics and baseline characteristics, concomitant diagnosis/therapy and medical history, as well as ADA.|||Participants|||Count of Participants
2551524|NCT02815670|Secondary|Number of Participants Per Bleeding Status During the Trial|Numbers of participants whose bleeding had stopped, reduced, unchanged, worsened or not applicable during the trial were characterized.|From vial 1 of Idarucizumab until prematurely discontinued of the trial, up to 25 days|Treated set (TS): including all patients who received any dose of Idarucizumab. The TS was used to assess safety, clinical endpoints, demographics and baseline characteristics, concomitant diagnosis/therapy and medical history, as well as ADA.|||Participants|||Count of Participants
2551525|NCT02815670|Secondary|Number of Participants With Cessation of Bleeding||From vial 1 of Idarucizumab through vial 2 of Idarucizumab, up to 24h 30min.|Treated set (TS): including all patients who received any dose of Idarucizumab. The TS was used to assess safety, clinical endpoints, demographics and baseline characteristics, concomitant diagnosis/therapy and medical history, as well as ADA.|||Participants|||Count of Participants
2551526|NCT02815670|Secondary|Duration of Reversal of the Dabigatran Effect Sustained up to 24 Hours Post-dose (Based on the Coagulation Time for dTT and ECT)|Duration of reversal, defined as the time period a patient remained completely reversed based on dTT and ECT, up to 24 hours post-dose or restarting the treatment of anticoagulation. Central blood sampling for dTT, ECT were to occur immediately prior to administration of each vial of idarucizumab and post-dose at 30min, 4h, 12h and 24h.|From end of vial 2 of Idarucizumab up to 24h.|Pharmacodynamic (PD) set (PDS): comprising all patients in the TS who provided at least 1 evaluable pre-dose and at least 1 post-dose observation for PD endpoints or biomarker measures. The PDS was used for the PD endpoint analyses. Note that for different PD endpoints or biomarkers, the number of evaluable patients could differ between endpoints.|||Hours|||Number
2551527|NCT02815670|Secondary|Time to Achieve Reversal of the Dabigatran Effect (Based on the Coagulation Time for dTT and ECT)|"Idarucizumab administration resulted in normalisation of dTT and ECT. Time to achieve reversal of anticoagulant effect of dabigatran based on the coagulation time for dTT and ECT, at any time point from the end of the second injection (vial 2) up to 24 hours (h). Reversal of the dabigatran effect at time t was defined as the 100 percent (%) *(pre-dose coagulation time - post-dose coagulation time at time t)/(pre-dose coagulation test - upper limit of normal).~Values equal to or higher than 100% were interpreted as reversal. Central blood sampling for dTT, ECT were to occur immediately prior to administration of each vial of Idarucizumab and post-dose at 30min, 4h, 12h and 24h."|From end of vial 2 of Idarucizumab up to 24h.|Pharmacodynamic (PD) set (PDS): comprising all patients in the TS who provided at least 1 evaluable pre-dose and at least 1 post-dose observation for PD endpoints or biomarker measures. The PDS was used for the PD endpoint analyses. Note that for different PD endpoints or biomarkers, the number of evaluable patients could differ between endpoints.|||Minutes|||Number
2551528|NCT02815670|Secondary|Percent Change of Coagulation Time for Diluted Thrombin Time (dTT) and Ecarin Clotting Time (ECT) at 30 Minutes Post-dose Compared With Pre-dose|Percent change of coagulation time for diluted thrombin time (dTT) and ecarin clotting time (ECT) at 30 minutes (min) post-dose compared with pre-dose. Central blood sampling for dTT, ECT were to occur immediately prior to administration of each vial of Idarucizumab and post-dose at 30min, 4h, 12h and 24h.|At immediately prior to administration of vial 1 of Idarucizumab and 30 minutes (min) post vial 2 administration.|Pharmacodynamic (PD) set (PDS): comprising all patients in the TS who provided at least 1 evaluable pre-dose and at least 1 post-dose observation for PD endpoints or biomarker measures. The PDS was used for the PD endpoint analyses. Note that for different PD endpoints or biomarkers, the number of evaluable patients could differ between endpoints.|||Percentage of time in seconds|||Number
2551529|NCT02815670|Primary|Number of Participants With Drug-related Adverse Events (AEs)|Number of participants with drug-related adverse events (AEs) including immune reactions and all cause mortality during the trial.|From vial 1 of Idarucizumab until prematurely discontinued of the trial, up to 25 days|Treated set (TS): including all patients who received any dose of Idarucizumab. The TS was used to assess safety, clinical endpoints, demographics and baseline characteristics, concomitant diagnosis/therapy and medical history, and antidrug antibodies (ADA).|||Participants|||Count of Participants
2551530|NCT02815644|Secondary|AUC0-72 for Linagliptin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours (AUC0-72) for linagliptin|2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.|PKS|||nmol∙h/L||Geometric Coefficient of Variation|Geometric Mean
2551531|NCT02815644|Secondary|AUC0-infinity for Empagliflozin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) for empagliflozin.|2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.|PKS|||nmol∙h/L||Geometric Coefficient of Variation|Geometric Mean
2551532|NCT02815644|Secondary|AUC0-infinity for Linagliptin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) for linagliptin|2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.|PKS|||nmol∙h/L||Geometric Coefficient of Variation|Geometric Mean
2551533|NCT02815644|Primary|AUC 0-tz for Empagliflozin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration (AUC 0-tz) for empagliflozin|2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.|PKS|||nmol∙h/L||Geometric Coefficient of Variation|Geometric Mean
2551534|NCT02815644|Primary|AUC 0-tz for Linagliptin|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration (AUC 0-tz) for linagliptin|2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.|PKS|||nmol∙h/L||Geometric Coefficient of Variation|Geometric Mean
2551535|NCT02815644|Primary|Cmax for Empagliflozin|Maximum measured concentration of the analyte in plasma (Cmax) for empagliflozin|2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.|PKS|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2551536|NCT02815644|Primary|Cmax for Linagliptin|Maximum measured concentration of the analyte in plasma (Cmax) for linagliptin|2 hours (h) before the administration in first subject and 0:20 h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h after drug administration.|Pharmacokinetic Set (PKS): The PKS included all 22 randomised subjects who were documented to have taken at least 1 dose of trial medication under fed or fasted condition without having protocol deviation relevant to the evaluation of relative bioavailability and without experiencing emesis at or before 2 times median tmax.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2551537|NCT02815397|Secondary|Safety Profile With Addition of Metformin Evaluated by Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v.4.0|Describe the safety profile observed by measuring fasting glucose and anion gap weekly through cycle 6.|18 months|will not have this data as study closed prematurely.||||||
2551538|NCT02815397|Secondary|Effect of Metformin Overall Survival|Evaluation of the addition of metformin to standard induction therapy on 18 month overall survival|18 months|will not have this data as study closed prematurely.||||||
2551539|NCT02815397|Secondary|Effect of Metformin Overall Response Rate|Evaluation of the effect of the addition of metformin to induction chemotherapy on overall response rates|3 years|no data available as study closed before response could be determined||||||
2551540|NCT02815397|Primary|Evaluation of Impact of Metformin on 18 Month Progression-free Survival|Progression-free survival determined by CT scans at 18 months|18 month|will not have this data as study closed prematurely.||||||
2551541|NCT02815293|Secondary|Change From Baseline in Tearfilm Break Up Time (TBUT)|For TBUT, the mean of 3 measurements of time in seconds will be computed at each visit for each eye. The mean value of the study eye will be used for analysis|Baseline (day 1) to 6 month visit|Efficacy analyses including the change from baseline in Tearfilm Break Up Time (TBUT) were planned. Ultimately, these analyses were not fully performed due to the early termination of the study and only six patients reaching the 6 month visit.|||Seconds||Standard Deviation|Mean
2551542|NCT02815293|Primary|Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe)|The overall ocular discomfort will be assessed on a questionnaire using a 0 to 4 scale on which 0=none, 1=mild, 2=moderate, 3=severe and 4=very severe.|6 month visit|Efficacy analyses including the overall ocular discomfort score were planned for the intent-to-treat (ITT) population who are defined as all randomized patients. Ultimately, these analyses were not fully performed due to the early termination of the study and only six patients reaching the 6 month visit.|||Score on a scale||Standard Deviation|Mean
2551543|NCT02814656|Secondary|Accumulation Ratio for AUC0-24 (Rac[AUC0-24]) for AZD8871 and Its Metabolites (Day 16).|Accumulation ratio for AUC0-24 (Rac[AUC0-24]) for AZD8871 and its metabolites (LAS191861 and LAS34850) estimated as (AUC(0-24) pg.h/mL on Day 16/ AUC(0-24) pg.h/mL on Day 1).|Days 1 and 16, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.|||Ratio||Full Range|Mean
2551544|NCT02814656|Secondary|Accumulation Ratio for Cmax (Rac[Cmax]) for AZD8871 and Its Metabolites (Day 16).|Accumulation ratio for Cmax estimated as (Cmax pg/mL on Day 16/ Cmax pg/mL on Day 1) of AZD8871 and its metabolites (LAS191861 and LAS34850).|Days 1 and 16, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.|||Ratio||Full Range|Mean
2551774|NCT02809183|Primary|Change From Baseline to the End of Treatment (Day 15) in Serum Bicarbonate Within Each Individual TRC101 Dose Group|Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline|Baseline and Day 15|Full Analysis Set|||mEq/L||Standard Error|Least Squares Mean
2551545|NCT02814656|Primary|Number of Participants With Clinically Relevant Abnormalities in 12-lead dECG (Including High Precision QTc Analysis) Findings.|The AZ ECG Centre performed the digital ECG (dECG) analysis in this study, using the EClysis© system, version 3.3, or higher. At protocol-indicated time points, 12-lead continuous dECG was recorded over at least 5 minutes with the Schiller Cardiovit CS-200 recorder (Schiller AG, Baar, Switzerland) and transmitted to the AZ central dECG repository, according to AZ ECG Centre´s standard procedures for settings, recording and transmission of dECGs|Changes from baseline up to Day 20|Safety analysis population: defined as all participants who received at least one dose of the investigational product and for whom any post-dose safety data were available.|||Participants|||Count of Participants
2551546|NCT02814656|Primary|Number of Participants With Clinically Relevant New Findings or Worsening of Pre-existing Findings as Assessed by Urinalysis Report.|Dipstick analysis was performed at the centre and included: pH, blood, leucocytes, protein, glucose, bilirubin, urobilinogen, ketones and nitrites. If clinically relevant abnormalities were detected (positive result in dipstick), microscopy (RBC, WBC and casts [Hyaline, Granular and Cellular]) were performed.|Changes from baseline up to Days 25-27|Safety analysis population: defined as all participants who received at least one dose of the investigational product and for whom any post-dose safety data were available.|||Participants|||Count of Participants
2551547|NCT02814656|Primary|Number of Participants With Clinically Relevant New Findings or Worsening of a Pre-existing Findings as Assessed by Clinical Chemistry.|Electrolytes: Sodium, potassium, calcium, chloride and inorganic phosphorus Enzymes: AST, ALT, ALP, GGT, LDH, creatine-kinase Substrates: Glucose (fasting), total cholesterol, triglycerides, creatinine, TBL, total protein, albumin, uric acid, urea and BUN Endocrinology: T4, TSH Viral Serology: HIV I and II antibodies, Hepatitis C antibodies, Hepatitis B surface antigen, Hepatitis B core (HBc) immunoglobulin antibodies Coagulation parameters: INR, PT, aPTT|Changes from baseline up to Days 25-27|Safety analysis population: defined as all participants who received at least one dose of the investigational product and for whom any post-dose safety data were available.|||Participants|||Count of Participants
2551548|NCT02814656|Primary|Number of Participants With Clinically Relevant Abnormalities in Telemetry ECG.|Recording of telemetry findings. A 2-lead real-time telemetry ECG was performed for at least 4 hours on Day -1 and then on Days 1, 10 and 16 from 30 minutes pre-dose until 24 hours post-dose. The telemetry monitoring system was reviewed by the Investigator or research nurse and paper printouts of any clinically important events were stored as source data.|Changes from baseline up to Day 20 (discharge from study unit)|Safety analysis population: defined as all participants who received at least one dose of the investigational product and for whom any post-dose safety data were available.|||Participants|||Count of Participants
2551549|NCT02814656|Primary|Number of Participants With Clinically Relevant Abnormalities in 12-lead Safety ECG.|A 12-lead ECG was obtained after the subject rested in the supine position for at least 10 minutes (could be reduced to 5 minutes at collection time points within the first hour after dosing) (using the sites own ECG machines when not performing dECGs and using the same machine as the dECGs when time points coincided).|Changes from baseline up to Days 25-27|Safety analysis population: defined as all participants who received at least one dose of the investigational product and for whom any post-dose safety data were available.|||Participants|||Count of Participants
2551550|NCT02814656|Primary|Number of Participants With Clinically Relevant New Findings or Worsening of Pre-existing Findings as Assessed by Haematology.|Haematocrit, haemoglobin, erythrocytes (red blood cells), mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, leucocytes (white blood cells), differential blood count (neutrophils, lymphocytes, monocytes, eosinophils and basophils), and thrombocytes (platelets).|Changes from baseline up to Days 25-27|Safety analysis population: defined as all participants who received at least one dose of the investigational product and for whom any post-dose safety data were available.|||Participants|||Count of Participants
2551551|NCT02814656|Primary|Number of Participants With Clinically Relevant Abnormalities in Vital Signs (Pulse, Blood Pressure and Body Temperature).|"Systolic and diastolic BP (SBP/DBP) (in mmHg) measured after at least 10 minutes (could be reduced to 5 minutes at collection time points within the 1st hour after dosing) resting, and also before taking any blood sample and conducting any spirometry. Measurements were carried out with subject in the supine position and preferably always on the same arm.~Subject's oral body temperature was measured at each vital signs collection."|Change from baseline up to Days 25-27|Safety analysis population: defined as all participants who received at least one dose of the investigational product and for whom any post-dose safety data were available.|||Participants|||Count of Participants
2551552|NCT02814656|Primary|Number of Participants With Clinically Relevant Abnormalities in Recording of Physical Examination.|"A full physical examination included the examination of the following: general appearance, eyes, ears, nose, throat, chest/respiratory, heart/cardiovascular, gastrointestinal/liver, musculoskeletal/extremities, dermatological/skin, thyroid/neck, lymph nodes, neurological/psychiatric.~A brief physical examination included assessment of the following: skin, lungs, cardiovascular system and abdomen (liver and spleen).~A complete physical examination was performed at the Screening Visit. Any abnormal finding assessed as the investigator as clinically relevant was reported as an adverse event."|Change from baseline up to Days 25-27|Safety analysis population: defined as all participants who received at least one dose of the investigational product and for whom any post-dose safety data were available.|||Participants|||Count of Participants
2551553|NCT02814656|Secondary|Apparent Volume of Distribution for Parent Drug at Terminal Phase (Vz/F) (Single Dose).|Apparent volume of distribution for parent drug at terminal phase (Vz/F) (extravascular administration), estimated by dividing the apparent clearance (CL/F) by λz of AZD8871.|Day 1, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.|||L||Standard Deviation|Mean
2551585|NCT02814448|Secondary|Mean Pain During Treatment Reported by Patients Treated With Double and Single Freeze CO2 Cryotherapy, Double and Single Freeze CryoPen and Thermoablation|Scale Title: Pain scale during treatment Minimal value = 0 (no pain) Maximum value = 10 (most pain) This is a one item 11-point scale to measure self-reported pain during each of the treatments which lasted between 40 seconds (thermoablation) and 13 minutes (double freeze cryotherapy and double freeze CryoPen).|40 seconds to 13 minutes||||units on a scale||Standard Deviation|Mean
2551554|NCT02814656|Secondary|Apparent Clearance for Parent Drug (CL/F) (Day 16).|Apparent clearance for parent drug (CL/F) estimated as dose divided by AUC(0-24) of AZD8871.|Day 16, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.|||L/h||Standard Deviation|Mean
2551555|NCT02814656|Secondary|Apparent Clearance for Parent Drug (CL/F) (Single Dose).|Apparent clearance for parent drug (CL/F) estimated as dose divided by AUC of AZD8871.|Day 1, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.|||L/h||Standard Deviation|Mean
2551556|NCT02814656|Secondary|AUC of AZD8871 and Its Metabolites (Single Dose).|"Area under the concentration-time curve of AZD8871 and its metabolites (LAS191861 and LAS34850) from time zero extrapolated to infinity.~AUC is estimated by AUC0-last + Clast/λz where Clast is the last observed quantifiable concentration."|Day 1, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.|||pg.h/mL||Geometric Coefficient of Variation|Geometric Mean
2551557|NCT02814656|Secondary|AUC(0-24) of AZD8871 and Its Metabolites (Day 16).|Area under the plasma concentration-curve from time zero to 24 hours post-dose (AUC[0-24]) of AZD8871 and its metabolites (LAS191861 and LAS34850).|Day 16, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.|||pg.h/mL||Geometric Coefficient of Variation|Geometric Mean
2551558|NCT02814656|Secondary|AUC(0-24) of AZD8871 and Its Metabolites (Single Dose).|Area under the plasma concentration-curve from time zero to 24 hours post-dose (AUC[0-24]) of AZD8871 and its metabolites (LAS191861 and LAS34850).|Day 1, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.|||pg.h/mL||Geometric Coefficient of Variation|Geometric Mean
2551559|NCT02814656|Secondary|Terminal Half-life (t½λz) of AZD8871 and Its Metabolites (Day 16).|Terminal elimination half-life (t½λz) of AZD8871 and its metabolites (LAS191861 and LAS34850), estimated as (ln2)/ λz.|Day 16, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.|||h||Standard Deviation|Mean
2551560|NCT02814656|Secondary|Terminal Half-life (t½λz) of AZD8871 and Its Metabolites (Single Dose).|Terminal elimination half-life (t½λz) of AZD8871 and its metabolites (LAS191861 and LAS34850), estimated as (ln2)/ λz.|Day 1, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.|||h||Standard Deviation|Mean
2551561|NCT02814656|Secondary|Time to Reach Maximum Concentration (Tmax) of AZD8871 and Its Metabolites (Day 16).|Time to reach maximum concentration, taken directly from the individual concentration-time curve (tmax) of AZD8871 and its metabolites (LAS191861 and LAS34850).|Day 16, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.|||h||Full Range|Median
2551562|NCT02814656|Secondary|Time to Reach Maximum Concentration (Tmax) of AZD8871 and Its Metabolites (Single Dose).|Time to reach maximum concentration, taken directly from the individual concentration-time curve (tmax) of AZD8871 and its metabolites (LAS191861 and LAS34850).|Day 1, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.|||h||Full Range|Median
2551563|NCT02814656|Secondary|Observed Maximum Concentration (Cmax) of AZD8871 and Its Metabolites (Day 16).|Observed maximum concentration, taken directly from the individual concentration-time curve (Cmax) of AZD8871 and its metabolites (LAS191861 and LAS34850).|Day 16, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2551564|NCT02814656|Secondary|Observed Maximum Concentration (Cmax) of AZD8871 and Its Metabolites (Single Dose).|Observed maximum concentration, taken directly from the individual concentration-time curve (Cmax) of AZD8871 and its metabolites (LAS191861 and LAS34850).|Day 1, pre-dose and at 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic analysis population: defined as all participants in the safety analysis population who received at least 1 dose of AZD8871 and had at least 1 of the parameters Cmax, AUC or AUClast evaluable for AZD8871 and were assumed not to be affected by factors such as protocol deviations.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2551565|NCT02814656|Primary|Number of Participants With ≥1 Treatment Emergent Adverse Event in Any Category.|"Recording treatment emergent adverse events (TEAE).~A TEAE was defined as an AE with onset (start date/time) after the first dose of investigational medicinal product. An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition can be symptoms (e.g., nausea, chest pain), signs (e.g., tachycardia, enlarged liver) or the abnormal results of an investigation (e.g., laboratory findings, ECG)."|Change from baseline up to Days 25-27|Safety analysis population: defined as all participants who received at least one dose of the investigational product and for whom any post-dose safety data were available.|||Participants|||Count of Participants
2551566|NCT02814643|Secondary|Change From Baseline in Mean Asthma Control Questionnaire 6 (ACQ-6) Score at Week 12|To compare the change from baseline at Week 12 in mean ACQ-6 score between patients receiving benralizumab 30mg and patients receiving placebo. The ACQ-6 assesses asthma symptoms (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and short-acting β2 agonist use). Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score is the mean of the responses to each question. Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and ≤1.5 indicate partly controlled asthma, and a score >1.5 indicates not well controlled asthma|12 weeks|The full analysis set included all patients who were randomized and received any investigational product.|||Score on a scale||Full Range|Mean
2551567|NCT02814643|Secondary|Proportion of Patients Who Experience a Strain-specific Postdose Antibody Response at Week 12 With Antibody Response Defined as a ≥4-fold Rise in Microneutralization Antibody Titer From Week 8 to Week 12|To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥4-fold rises in microneutralization antibody titer from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.|4 weeks|The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.|||Proportion of Participants||90% Confidence Interval|Number
2551568|NCT02814643|Secondary|Postdose Strain-specific Serum Microneutralization Antibody Geometric Mean Titers Obtained at Week 12|To compare the geometric mean titers of microneutralization antibody as a measure of influenza strain-specific response at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.|12 weeks|The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.|||Antibody titer||Geometric Coefficient of Variation|Geometric Mean
2551569|NCT02814643|Secondary|Postdose Strain-specific Microneutralization Antibody Geometric Mean Fold Rise From Week 8 to Week 12|"To compare the geometric mean fold rises in influenza strain-specific microneutralization antibody responses from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo. Geometric mean fold rise was defined as antilog(z) (mean [log(z) x]), where x is the postdose microneutralization antibody titer fold rise from Week 8 and z is the natural logarithm."|4 weeks|The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.|||Fold change||Geometric Coefficient of Variation|Geometric Mean
2551570|NCT02814643|Secondary|Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination Inhibition Antibody Titre ≥320 at Week 12|To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥320-fold rises in hemagglutination-inhibition antibody titer at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.|12 weeks|The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.|||Proportion of Participants||90% Confidence Interval|Number
2551571|NCT02814643|Primary|Proportion of Patients Who Achieved a Strain-specific Postdose Hemagglutination-inhibition Antibody Titer ≥40 at Week 12|To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥40-fold rises in hemagglutination-inhibition antibody titer at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.|12 weeks|The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.|||Proportion of Participants||90% Confidence Interval|Number
2551572|NCT02814643|Primary|Proportion of Patients Who Experienced a Strain-specific Postdose Antibody Response at Week 12 With Antibody Response Defined as a ≥4-fold Rise in Hemagglutination-inhibition Antibody Titer From Week 8 to Week 12|To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥4-fold rises in hemagglutination-inhibition antibody titer from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.|4 weeks|The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.|||Proportion of Participants||90% Confidence Interval|Number
2551573|NCT02814643|Primary|Postdose Strain-specific Hemagglutination-inhibition Antibody Geometric Mean Titers Obtained at Week 12|To compare the geometric mean titers of hemagglutination-inhibition antibody as a measure of influenza strain-specific response at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.|12 weeks|The vaccine immunogenicity analysis set included all randomized patients who received at least 1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or MN antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.|||Antibody titer||Standard Error|Geometric Least Squares Mean
2551574|NCT02814643|Primary|Postdose Strain-specific Hemagglutination-inhibition (HAI) Antibody Geometric Mean Fold Rise From Week 8 to Week 12|"To compare the geometric mean fold rises in influenza strain-specific hemagglutination-inhibition responses from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo. Geometric mean fold rise was defined as antilog(z) (mean [log(z) x]), where x is the postdose HAI antibody titer fold rise from Week 8 and z is the natural logarithm."|4 weeks|The vaccine immunogenicity analysis set included all randomized patients who received ≥1 dose of planned study drugs, had pre- (Week 8) and postdose (Week 12) HAI or microneutralization antibody measurements, and had no protocol deviations judged to have the potential to interfere with the generation or interpretation of an antibody response.|||Fold change||Standard Error|Geometric Least Squares Mean
2551575|NCT02814565|Secondary|Percentage of Participants With Physician Rated Assessment of Limitation of Activities of Daily Living on Days 3, 7, and 15 of Treatment|"The investigator assessed limitation of activities based on evaluation of the patient's reported functional assessment. The following 5-point rating scale was used: 1 = none, 2 = mild, 3 = moderate, 4 = moderately severe, 5 = severe."|Days 3, 7, and 15|FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.|||percentage of percentage|||Number
2551576|NCT02814565|Secondary|Percentage of Participants With Physician Rated Assessment of Limitation of Range of Motion on Days 3, 7, and 15 of Treatment|"The investigator assessed limitation of range of motion. The following 5-point rating scale was used: 1 = none, 2 = mild, 3 = moderate, 4 = moderately severe, 5 = severe."|Days 3, 7, and 15|FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.|||percentage of participants|||Number
2551577|NCT02814565|Secondary|Percentage of Participants With Physician Rated Assessment of Presence of Local Pain on Days 3, 7, and 15 of Treatment|"The investigator assessed local pain based on physical examination, reaction to palpation (presence of local pain assessment). The following 5-point rating scale was used: 1 = none, 2 = mild, 3 = moderate, 4 = moderately severe, 5 = severe."|Days 3, 7, and 15|FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.|||percentage of participants|||Number
2551578|NCT02814565|Secondary|Percentage of Participants With Physician Rated Assessment of Presence of Muscle Spasm on Days 3, 7, and 15 of Treatment|"The investigator assessment based on physical examination, presence of muscle spasm (presence of muscle spasm assessment). The following 5-point rating scale was used: 1 = none, 2 = mild, 3 = moderate, 4 = moderately severe, 5 = severe."|Days 3, 7, and 15|FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.|||percentage of participants|||Number
2551579|NCT02814565|Secondary|Percentage of Responders on Days 3, 7, and 14 of Treatment|"A responder was defined as a participant who had both a rating of either very good or excellent for the participant's rating of medication helpfulness."|Days 3, 7, and 14|FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.|||percentage of participants|||Number
2551580|NCT02814565|Secondary|Percentage of Participants With Subject-Rated Global Impression on Days 3, 7, and 14 of Treatment|"Participants assessed their clinical global impression based on relief from local pain, restriction in activities of daily living, restriction of movement and intensity of local pain on a daily basis. The following 5-point rating scale was used: 1 = worse, 2 = no change, 3 = slight improvement, 4 = moderate improvement, 5 = marked improvement."|Days 3, 7, and 14|FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.|||percentage of participants|||Number
2551581|NCT02814565|Secondary|Percentage of Participants With Physician's Clinical Global Assessment on Days 7 and 15 of Treatment|"The investigator assessed their clinical global impression of change compared to Baseline, based on physical examination, degree of muscle spasm (presence of muscle spasm assessment), reaction to palpation (presence of local pain assessment), limitation of range of motion, and evaluation of the patient's reported functional assessment (limitation of activities of daily living assessment). The following 5-point rating scale was used: 1 = worse, 2 = no change, 3 = slight improvement, 4 = moderate improvement, 5 = marked improvement."|Days 7 and 15|FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.|||percentage of participants|||Number
2551582|NCT02814565|Secondary|Percentage of Participants With Physician's Clinical Global Assessment on Day 3 of Treatment|"The investigator assessed their clinical global impression of change compared to Baseline, based on physical examination, degree of muscle spasm (presence of muscle spasm assessment), reaction to palpation (presence of local pain assessment), limitation of range of motion, and evaluation of the patient's reported functional assessment (limitation of activities of daily living assessment). The following 5-point rating scale was used: 1 = worse, 2 = no change, 3 = slight improvement, 4 = moderate improvement, 5 = marked improvement."|Day 3|FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.|||percentage of participants|||Number
2551583|NCT02814565|Secondary|Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Days 7 and 14 of Treatment|"Participants assessed the study medication helpfulness on a daily basis (in the daily diary), using the following 5-point rating scale: How would you rate this study medication in improving your condition? 0 = poor, 1 = fair, 2 = good, 3 = very good, 4 = excellent."|Days 7 and 14|FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.|||percentage of participants|||Number
2551584|NCT02814565|Primary|Percentage of Participants With Subject's Rating of Medication Helpfulness Impression on Day 3 of Treatment|"Participants assessed the study medication helpfulness on a daily basis (in the daily diary), using the following 5-point rating scale: How would you rate this study medication in improving your condition? 0 = poor, 1 = fair, 2 = good, 3 = very good, 4 = excellent."|Day 3|FAS included participants who received at least one dose of investigation product, analyzed according to original treatment assignment.|||percentage of participants|||Number
2551586|NCT02814448|Primary|Mean Depth of Necrosis Achieved With the LMIC-adapted CryoPen and the Thermocoagulator Compared to Mean Depth of Necrosis Achieved With CO2-based Cryotherapy||24-48 hours after treatment||||millimeters||Standard Deviation|Mean
2551587|NCT02814279|Secondary|Root Coverage Esthetic Score|The Root Coverage Esthetic Scale (RES; Cairo et al. 2009) was performed by two blinded and independent examiners (CFA and IFM) at the 6-month post-operative assessment. This score evaluates five variables: level of the gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color. Because complete root coverage was the primary treatment goal, and the other variables were considered secondary, the value assigned for root coverage was 60% of the total score, whereas 40% was assigned to the other four variables. With regard to assessment of the final position of the gingival margin, 3 points were given for partial root coverage, and 6 points were given for complete root coverage; 0 points were assigned when the final position of the gingival margin was equal or apical to the previous recession. One point was assigned for each of the other four variables. Thus, 10 points was a perfect score.|6 months||||units on a scale|photographs|Standard Deviation|Mean
2551588|NCT02814279|Primary|Percentage of Defect Coverage|Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.|6 months||||percentage of root coverage||Standard Deviation|Mean
2551589|NCT02814227|Secondary|Negative Predictive Value (NPV)|NPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals|8 hours||||negative predictive value|||Number
2551590|NCT02814227|Secondary|Positive Predictive Value (PPV)|PPV of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals|8 hours||||positive predictive value|||Number
2551591|NCT02814227|Secondary|Sensitivity|Sensitivity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals|8 hours||||percentage of true positives|||Number
2551592|NCT02814227|Primary|Specificity|Specificity of Zansors' device to detect apnea events compared to gold-standard polysomnography over an 8-hour period of sleep at 30-second intervals|8 hours||||percentage of true negatives|||Number
2551593|NCT02813694|Secondary|Investigator's Assessment of Clinical Response (IACR)|IACR was defined as resolution or improvement of a subject's clinical signs and symptoms such that no additional antibacterial therapy was administered for the treatment of the current episode of CABP|IACR was assessed at the Test-of-Cure Visit; 5 to 10 days after last dose of study drug|Clinically Evaluable population: Subset of ITT population having met additional pre-defined criteria.|||Participants|||Count of Participants
2551594|NCT02813694|Secondary|Investigator's Assessment of Clinical Response (IACR)|IACR was defined as resolution or improvement of a subject's clinical signs and symptoms such that no additional antibacterial therapy was administered for the treatment of the current episode of CABP|IACR was assessed at the Test-of-Cure Visit; 5 to 10 days after last dose of study drug|Modified ITT population: All randomized subjects who received any amount of study drug|||Participants|||Count of Participants
2551595|NCT02813694|Primary|Early Clinical Response (ECR)|ECR was defined as survival with improvement in at least 2 signs and symptoms of CABP (relative to baseline), no worsening of any CABP sign or symptom, and no use of concomitant antibiotics for the treatment of CABP through the ECR assessment|96 hours +/- 24 hours after first dose of study drug|Intent to Treat Analysis Set: All randomized subjects|||Participants|||Count of Participants
2551596|NCT02813681|Secondary|Number of Needle Insertions|The investigator will count the number epidural needle insertions during the epidural placement (whole number)|The number of needle insertions will be counted during epidural placement.||||number of needle insertions||Standard Error|Mean
2551597|NCT02813681|Secondary|Number of Needle Repositions|The investigator will count the number epidural needle repositions during the epidural placement (whole number)|The number of needle reposition will be counted during epidural placement.|The SVD without an epidural is not included in this analysis because this group did not get an epidural and therefore will not have needle repositions.|||number of needle repositions||Standard Error|Mean
2551598|NCT02813681|Secondary|Short-term Back Pain|The investigator will ask the participant if they have had back pain lasting longer than one week during pregnancy? (yes answer will be recorded)|Participants will be asked if they have had back pain for longer than a week immediately prior to epidural placement||||Participants|||Count of Participants
2551599|NCT02813681|Secondary|Opioid Use During Labor|The investigator will review the chart to see if the participant required opioids during labor (yes will be recorded)|A chart review of systemic opioids given to participant when the epidural is removed||||Participants|||Count of Participants
2551600|NCT02813681|Secondary|Induction Medication|The investigator will review the chart to see if the participant used of induction medication (answer yes will be recorded)|The chart review will determine the use of induction medication immediately prior to the epidural placement||||Participants|||Count of Participants
2551601|NCT02813681|Primary|Epidural Pressure Sensitivity at Level of Epidural Insertion|pressure sensitivity at level of epidural insertion will be measured with an algometer (Newtons)|Epidural pressure sensitivity was monitored 10 minutes prior to epidural insertion and then for 10 minutes on each day after epidural removal for 3 days.|pressure sensitivity at level of epidural insertion will be measured at epidural insertion site level.|||force (newtons/cm^2)||Standard Error|Mean
2551602|NCT02813577|Secondary|Change of Resting Ankle Brachial Index (ABI) Scores at 1, 6, 12, and 24 Months Post Index Procedure Compared to Baseline||1, 6, 12 and 24 months post index procedure|Study was terminated.||||||
2551603|NCT02813577|Secondary|Number of Participants With Sustained Clinical Benefit at 1, 6, 12, and 24 Months Post Index Procedure||1, 6, 12 and 24 months post index procedure|Study was terminated.||||||
2551604|NCT02813577|Secondary|Change in Rutherford Classification Scores at 1, 6, 12, and 24 Months Post Index Procedure Compared to Baseline||1, 6, 12 and 24 months post index procedure|Study was terminated.||||||
2551605|NCT02813577|Secondary|Number of Participants With Amputation (Above the Ankle)-Free Survival (AFS) at 1, 6, 12, and 24 Months Post Index Procedure.||1, 6, 12 and 24 months|Study was terminated.||||||
2551606|NCT02813577|Secondary|Number of Participants With Unanticipated and Anticipated Device Related Serious Adverse Events at 1, 6, 12, and 24 Months Post Index Procedure||1, 6, 12 and 24 months post index procedure|Study was terminated.||||||
2551607|NCT02813577|Secondary|Number of Participants With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 1, 6, 12, and 24 Months Post Index Procedure||1, 6, 12 and 24 months post index procedure|Study was terminated.||||||
2551613|NCT02813577|Primary|Effectiveness: Number of Participants With Primary Patency of the Target Lesion at 12 Month Post Index Procedure.|Primary patency is defined as freedom from target lesion restenosis (TLR) and from binary restenosis. Binary restenosis is adjudicated by the independent Core Laboratory based on Peak Systolic Velocity Ratio (PSVR) ≥ 2.5 and / or abnormal waveforms, or based on angiographic ≥ 50% diameter stenosis.|12 months post index procedure|Study was terminated.||||||
2551614|NCT02813577|Primary|Number of Participants With Freedom From the Following: All-cause Peri-operative Death at 30 Days, Index Limb Amputation Within 1 Year, Index Limb Re-intervention Within 1 Year, and Index-limb-Related Death Within 1 Year Post Index Procedure|Index limb amputation includes above or below the ankle amputations.|12 months post index procedure|Study was terminated.||||||
2551615|NCT02813551|Other Pre-specified|Electrolyte Profile in Maternal Serum|Concentrations of: Sodium, Potassium, Calcium|0-5 days after delivery|||||||
2551616|NCT02813551|Other Pre-specified|Torsemide Concentrations in Breast Milk|Ancillary study|0-5 days after delivery|||||||
2551617|NCT02813551|Secondary|Number of Participants With Severe Composite Maternal Morbidity|Severe composite maternal morbidity is defined as having any of the following: ICU admission, HELLP syndrome, eclampsia, stroke, renal failure, pulmonary edema, cardiomyopathy, or maternal death.|0-6 weeks after delivery|Intention-to-treat|||Participants|||Count of Participants
2551618|NCT02813551|Secondary|Number of Participants With Side Effects of Therapy - Decreased Breast Milk||0-5 days after delivery|Intention-to-treat|||Participants|||Count of Participants
2551619|NCT02813551|Secondary|Number of Participants With Side Effects of Therapy - Hypokalemia (Low Blood Potassium Levels)||0-5 days after delivery|Blood potassium levels were only collected for 22 in the torsemide group and 31 in the placebo group.|||Participants|||Count of Participants
2551620|NCT02813551|Secondary|Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)||6 weeks after delivery|36 women in the torsemide group and 28 women in the placebo group did not show to their clinic appointment 6 weeks after delivery, resulting in 23 in the torsemide group and 31 in the placebo group being analyzed.|||Participants|||Count of Participants
2551621|NCT02813551|Secondary|Number of Participants With Persistent Postpartum Hypertension (Systolic Blood Pressure ≥140 and/or Diastolic Blood Pressure ≥ 90 mmHg)||7-10 days after delivery|38 (42%) women in the torsemide group and 31 (53%) women in the placebo missed their outpatient clinic visit at 7-10 days after delivery, resulting in only 21 in the torsemide group and 28 in the placebo group being analyzed.|||Participants|||Count of Participants
2551622|NCT02813551|Secondary|Change in Lower Extremity Edema|Lower extremity edema was assessed by measuring right ankle circumference at 5 centimeters above the medial malleolus.|at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery)|Intention-to-treat|||millimeters||Standard Deviation|Mean
2551623|NCT02813551|Secondary|Weight Change||at the time of randomization (within 24 hours of delivery); at discharge (about 1-5 days after delivery)|Intention-to-treat|||pounds||Standard Deviation|Mean
2551624|NCT02813551|Secondary|Length of Hospital Stay After Delivery||0-5 days after delivery|Intention-to-treat|||hours||Inter-Quartile Range|Median
2551625|NCT02813551|Secondary|Number of Participants Requiring Postpartum Readmission||0-6 weeks after delivery|Intention-to-treat|||Participants|||Count of Participants
2551626|NCT02813551|Secondary|Number of Participants With Severe Postpartum Hypertension Requiring Acute Antihypertensives (Systolic Blood Pressure ≥160 and/or Diastolic Blood Pressure ≥ 110 mmHg)||0-6 weeks after delivery|Intention-to-treat|||Participants|||Count of Participants
2551627|NCT02813551|Primary|Number of Participants With Persistent Postpartum Hypertension Defined as Systolic Blood Pressure ≥ 150 and/or Diastolic Blood Pressure ≥ 100 mmHg|Persistent postpartum hypertension was defined as sustained systolic blood pressure ≥ 150 or diastolic blood pressure ≥ 100 mmHg by postpartum day 5 or at hospital discharge, whichever occurred first.|0-5 days after delivery|Intention-to-treat|||Participants|||Count of Participants
2551628|NCT02813473|Secondary|Agreement in Coronary Stenosis Segments to be Revascularized Between and Within Strategies at Screening|Analysis has not been done.|Nov 2017|||||||
2551629|NCT02813473|Secondary|Concordance in SYNTAX Score(s) Between and Within Strategies at Screening|Analysis has not been done.|Nov 2017|||||||
2551630|NCT02813473|Secondary|CT Based Functional Anatomy (FFRCT as Assessed by Heartflow) at Screening|Analysis has not been done.|Nov 2017|||||||
2551631|NCT02813473|Secondary|Anatomical SYNTAX Score Calculation Based on Invasive Angiography (Visual by Core Lab) and the Resulting SYNTAX Score II at Screening|Analysis has not been done.|Nov 2017|||||||
2551632|NCT02813473|Secondary|Anatomical SYNTAX Score Calculation Based Invasive Angiography (Visual by Heart Team) and the Resulting SYNTAX Score II at Screening|Analysis has not been done.|Nov 2017|||||||
2551633|NCT02813473|Secondary|Anatomical SYNTAX Score Calculation Based on Non-invasive GE Revolution CT (Visual by Core Lab) and the Resulting SYNTAX Score II at Screening|Analysis has not been done.|Nov 2017|||||||
2551634|NCT02813473|Secondary|Anatomical SYNTAX Score Calculation Based on Non-invasive GE Revolution CT (Visual by Heart Team Involving an Experienced Coronary CT Reader) and the Resulting SYNTAX Score II at Screening|Analysis has not been done.|Nov 2017|||||||
2551635|NCT02813473|Secondary|"Inter-rater Agreement on Revascularization Strategy (Based on Conventional Angiography and CT With Functional Assessment) of Two Heart Teams Using an Angio-first Algorithm or a CT-first Algorithm at Screening"|Analysis has not been done.|Nov 2017|||||||
2551636|NCT02813473|Secondary|"Level of Agreement in the Decision Making Strategy Based on Conventional Angiography Only and the Decision Making Strategy Based on CT With Functional Assessment and Conventional Angiography (Angio First Algorithm Group) at Screening"|Analysis has not been done.|Nov 2017|||||||
2551637|NCT02813473|Secondary|"Level of Agreement in the Decision Making Strategy Based on CT Only (With Functional Assessment) and the Decision Making Strategy Based on CT With Functional Assessment and Conventional Angiography (CT First Algorithm Group) at Screening"|Analysis has not been done.|Nov 2017|||||||
2551638|NCT02813473|Secondary|"Level of Agreement in the Decision Making Strategy Based on CT Only Without Functional Assessment and the Decision Making Strategy Based on CT With Functional Assessment (CT First Algorithm Group) at Screening."|Analysis has not been done.|Nov 2017|||||||
2551639|NCT02813473|Primary|"Inter-rater Agreement on Revascularization Strategy of Two Heart Teams Using an Angio-first Algorithm or a CT First Algorithm."|"Inter-rater agreement, as assessed by Cohen's Kappa Kappa, on revascularization strategy of two Heart Teams using an Angio-first algorithm (based on invasive SYNTAX Score II) or a CT-first algorithm (based on non-invasive SYNTAX Score II, without FFRCT) and 95% confidence intervals (CI)."|Heart Team meetings took place in average 1 to 2 weeks afer patient enrollment||||proportion of agreement||95% Confidence Interval|Number
2551640|NCT02813070|Primary|Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Japanese Readers|The performance of Flutemetanol F 18 injection in participants was determined by evaluation of the level of association between the blinded visual assessment of a participant's brain image and the participant's clinical diagnosis by 5 Japanese readers, who classified each participant's images as either normal or abnormal (raised) Flutemetanol F 18 uptake.|Up to 90 minutes after IMP administration|Efficacy population consisted of all participants who had evaluable images following Flutemetamol F 18 injection and evaluable anatomic MRI images. As prospectively planned in the protocol, only participants enrolled with a clinical diagnosis of HV or pAD were included in the analysis of the primary endpoint.|||Participants|||Count of Participants
2551641|NCT02813070|Primary|Blinded Visual Assessment of Positron Emission Tomography (PET) Imaging and Clinical Diagnosis by Non-Japanese Readers|The performance of Flutemetanol F 18 injection in participants was determined by evaluation of the level of association between the blinded visual assessment of a participant's brain image and the participant's clinical diagnosis by 5 non-Japanese readers, who classified each participant's images as either normal or abnormal (raised) Flutemetanol F 18 uptake.|Up to 90 minutes after investigational medicinal product (IMP) administration|Efficacy population consisted of all participants who had evaluable images following Flutemetamol F 18 injection and evaluable anatomic MRI images. As prospectively planned in the protocol, only participants enrolled with a clinical diagnosis of HV or pAD were included in the analysis of the primary endpoint.|||Participants|||Count of Participants
2551642|NCT02812342|Secondary|Treatment Response Assessed as the Number of Participants With Hair Regrowth|Clinical photographs will be used to demonstrate presence or absence of hair regrowth. Presented is a count of people that did respond to treatment.|6 Months||||Participants|||Count of Participants
2551643|NCT02812342|Primary|Percent Change in Severity of Alopecia Tool (SALT) Score|SALT score range is from 0 (no hair loss) to 100 (100% hair loss). A positive percent change from baseline corresponds to a reduction in SALT score, and in this study study will be measured between baseline and 6 months.|6 Months||||percent change||Full Range|Mean
2551644|NCT02812238|Primary|Mean IL-1 Beta Release From Peripheral Blood Mononuclear Cells During Refeeding After 24 Hour Fast|The IL- 1beta secretion is measured in response to fasting, refeeding and administration of Nicotinamide Riboside (or placebo). Nicotinamide riboside acts as a fasting mimetic, and is supposed to maintain the reduction of IL-1 beta secretion (indicating NLRP3 inflammasome activation) induced by fasting. 1000 mg of Nicotinamide riboside on a daily basis is given to the subjects for a period of 7-10 days.|4 weeks||||mg/dL||Standard Deviation|Mean
2551645|NCT02812186|Secondary|Surgical Rating Scale|"To compare surgical operating condition by Surgical Rating Scale (SRS) in patients undergoing laparoscopic procedures using deep NMB versus moderate NMB~Surgical Rating Score scores are on a 1-5 scale with 1 = extremely poor conditions, 2 = poor conditions, 3 = adequate conditions, 4 = good conditions, 5= excellent conditions. Higher scores mean a better outcome."|Intra-operative, from intubation time to extubation time||||units on a scale||Inter-Quartile Range|Median
2551646|NCT02812186|Secondary|Abdominal Insufflation Pressure|To compare surgical operating condition by Abdominal Insufflation Pressure in patients undergoing laparoscopic procedures using deep NMB versus moderate NMB|Intra-operative, from intubation time to extubation time||||mmHg||Inter-Quartile Range|Median
2551647|NCT02812186|Primary|Peak Airway Pressures|To determine if a deep NMB can lead to lower peak airway pressures in patients undergoing laparoscopic procedures when compared to a moderate NMB|Intra-operative, from intubation time to extubation time||||cm H2O||Inter-Quartile Range|Median
2551648|NCT02811965|Primary|Peak Pressure Index on the Heel|Peak pressure index calculated by centering a 3 X 3 region of interest (14.52 cm^2) over maximum pressure sensor reading within the region of interest encompassing the heel.|5 minutes of pressure mapping||||mmHg||Standard Deviation|Mean
2551649|NCT02811965|Primary|Average Contact Force Exerted on the Heel|Average contact force calculated from an area of 40.32 cm^2 that encompassed the entire posterior heel. Pressure readings obtained by pressure mapping|5 minutes of pressure mapping||||mmHg||Standard Deviation|Mean
2551650|NCT02811419|Secondary|Number of Participants With Conventional Adenoma Detected||12 months||||Participants|||Count of Participants
2551651|NCT02811419|Primary|Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected||12 months||||Participants|||Count of Participants
2551652|NCT02811302|Primary|To Derive and Validate a Risk Assessment Tool to Identify Subjects at Risk of Having RD While Undergoing Opioid Therapy on the Hospital Ward|A risk assessment tool will be derived and validated using the incidence of RD episodes captured by continuous capnography and pulse oximetry measurements recorded on the Capnostream device memory data in conjunction with the clinical data as reported by the investigator.|48 hours|A modified dataset (mFAS) was used to derive and validate the risk assessment tool. Subjects excluded from the mFAS had major deviations or consent withdrawals or had no continuous monitoring data.|||Participants|||Count of Participants
2551653|NCT02811302|Primary|Determine Number of Subjects With RD While on Opioid Therapy|"Continuous respiratory monitoring using a Capnostream monitor will be included for collecting data for end tidal carbon dioxide (etCO2) and Oxygen saturation (SpO2). Positive RD determination was provided by an independent Clinical Event Committee, by assessing the following parameters:~etCO2 ≤ 15 or ≥ 60 mmHg for ≥ 3 minutes, or~RR ≤ 5 breaths for ≥ 3 minutes, or~SpO2 ≤ 85% for ≥ 3 minutes, or~Apnea episode lasting > 30 seconds, or~Any respiratory Opioid-Related Adverse Event (rORADE)."|48 hours|A modified dataset (mFAS) was used to derive and validate the risk assessment tool. Subjects with major deviations or consent withdrawals; subjects which had no continuous monitoring data were also excluded. A total of 1336 patients were included in the derivation and validation of the tool.|||Participants|||Count of Participants
2551654|NCT02811159|Primary|Percentage Change From Baseline in Total Uterine Fibroid Volume|The total uterine fibroid volume was measured by Magnetic Resonance Imaging (MRI). A negative percentage change from Baseline indicates improvement.|Baseline to the end of 18-weeks Treatment Course 1|ITT population Included all participants who received study drug. MRI data was only available for 3 participants.|||percent change||Standard Deviation|Mean
2551655|NCT02811159|Primary|Change From Baseline in Pictorial Blood Loss Assessment Chart (PBAC) Score|Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss. Participants recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Pictorial scores range from score 1 for slightly stained tampon/towel, 5 for a partially stained tampon/towel, 10 for a completely saturated tampon, 20 for a completely saturated towel, and 5 for each episode of flooding and for each blood clot larger than a quarter in size. Total score can range from 0 (no bleeding) to >500. Higher scores indicate more bleeding. Lower scores indicate less bleeding. A negative change from Baseline indicates improvement (reduction in bleeding).|Baseline to the end of 18-weeks Treatment Course 1|ITT population Included all participants who received study drug.|||score on a scale||Standard Deviation|Mean
2551656|NCT02811159|Primary|Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 8|"UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 8: During the previous 3 months how distressed were you by feeling fatigued? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline to the end of 18-weeks Treatment Course 1|ITT population included all participants who received study drug.|||percent change||Standard Deviation|Mean
2551657|NCT02811159|Primary|Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 7|"UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 7: During the previous 3 months how distressed were you by frequent night time urination? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline to the end of 18-weeks Treatment Course 1|ITT population included all participants who received study drug.|||percent change||Standard Deviation|Mean
2551658|NCT02811159|Primary|Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 6|"UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 6: During the previous 3 months how distressed were you by frequent urination during the daytime hours? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline to the end of 18-weeks Treatment Course 1|ITT population included all participants who received study drug.|||percent change||Standard Deviation|Mean
2551659|NCT02811159|Primary|Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 5|"UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 5: During the previous 3 months how distressed were you by feeling tightness or pressure in your pelvic area? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline to the end of 18-weeks Treatment Course 1|ITT population included all participants who received study drug.|||percent change||Standard Deviation|Mean
2551660|NCT02811159|Primary|Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 4|"UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 4: During the previous 3 months how distressed were you by fluctuation in the length of your monthly cycle compared to your previous cycles? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline to the end of 18-weeks Treatment Course 1|ITT population included all participants who received study drug.|||percent change||Standard Deviation|Mean
2551661|NCT02811159|Primary|Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 3|"UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 3: During the previous 3 months how distressed were you by fluctuation in the duration of your menstrual period compared to your previous cycle? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline to the end of 18-weeks Treatment Course 1|ITT population included all participants who received study drug.|||percent change||Standard Deviation|Mean
2551662|NCT02811159|Primary|Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 2|"UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 2: During the previous 3 months how distressed were you by passing blood clots during your menstrual period? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline to the end of 18-weeks Treatment Course 1|ITT population included all participants who received study drug.|||percent change||Standard Deviation|Mean
2551663|NCT02811159|Primary|Percentage Change From Baseline in the Individual UFS-SSS Subscale Score Question 1|"UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 1: During the previous 3 months how distressed were you by heavy bleeding during your menstrual period? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline to the end of 18-weeks Treatment Course 1|ITT population included all participants who received study drug.|||percent change||Standard Deviation|Mean
2551729|NCT02809833|Primary|SJC at Baseline|A total of 28 joints were assessed for swollenness. The number of swollen joints at Baseline was reported and could range from 0 to 28, where higher values represented more swollen joints.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||swollen joints||Standard Deviation|Mean
2551664|NCT02811159|Primary|Percentage Change From Baseline in Total Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score|UFS-SSS is an 8-question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. Each question was answered on a 5-point scale where 1=Not at all to 5=A very great deal. The sum of the total scores was transformed to a range of 0=no symptoms (best) to 100=most severe symptoms (worst). A negative percentage change from Baseline indicates improvement.|Baseline to the end of 18-weeks Treatment Course 1|ITT population included all participants who received study drug.|||percent change||Standard Deviation|Mean
2551665|NCT02811159|Primary|Percentage of Participants in Amenorrhea|Amenorrhea was defined as no bleeding intensity score greater than 1 using the Daily Diary Card during the 28 days leading up to the last day of dosing at Week 18. Bleeding intensity was graded on a 5-point scale where: 0=no bleeding to 4=heavy bleeding.|At the end of 18 weeks Treatment Course 1|Intent-to-treat (ITT) population included all participants who received study drug.|||percentage of participants|||Number
2551666|NCT02810873|Secondary|Ability of Copper Cu 64 TP3805 to Detect Primary Breast Lesions as Determined by Histology (Sensitivity)|Optimal imaging time is the one (of the three) which will have least background activity in the surrounding tissue and image the maximum number of lesions with clarity. 95% confidence intervals will be used. To account for the multiplicity of lesions per patient, the GEE approach will be used, with the robust variance. Any adverse events will be summarized descriptively.|4 hours after Cu 64 TP3805 administered|No data were collected or reported as tumors were not extracted and histology could not be performed||||||
2551667|NCT02810873|Primary|Number of F-18-FDG Positive Lesions That Are Detected by the Copper Cu 64 TP3805 Analog|Cu-64 results will be compared with those of F-18-FDG for: The unit of analysis will be the lesion (with potentially multiple lesions available per patient).|4 hours after Cu 64 TP3805 administered||||Number of Lesions|||Number
2551668|NCT02810509|Secondary|Percentage of INR Values in the Therapeutic Range of 2.0-3.0: Numbers of INR Values Within the Therapeutic Range by the Total Numbers of INR Measured.|The secondary outcome is the percentage of INR values in the therapeutic range of 2.0-3.0: numbers of INR values within the therapeutic range divided by the total numbers of INR measured.|We will analyze INR data of patients who had AF-related ischemic stroke and were treated with warfarin therapy at least for more than 7 days of warfarin adjustment period. (The INR follow up duration: 1 ~ maximum 3 years)||||Number of INR measured|Number of INR measured||Count of Units
2551669|NCT02810509|Primary|Time in TTR, the Percentage of Time in the Therapeutic Range of INR Between 2.0-3.0.|The primary outcome is TTR as measured by the percentage of time in the therapeutic range of INR between 2.0-3.0, using the Rosendaal linear interpolation method.|We will analyze INR data of patients who had AF-related ischemic stroke and were treated with warfarin therapy at least for more than 7 days of warfarin adjustment period. (The INR follow up duration: 1 ~ maximum 3 years)||||percentage of time in therapeutic range||Standard Deviation|Mean
2551670|NCT02810457|Other Pre-specified|Physical Examination||Up to approximately 30 days after last dose of study treatment.|||||||
2551671|NCT02810457|Other Pre-specified|Eastern Collaborative Oncology Group Performance Status||Up to approximately 30 days after last dose of study treatment.|||||||
2551672|NCT02810457|Other Pre-specified|Electrocardiogram||Up to approximately 30 days after last dose of study treatment.|||||||
2551673|NCT02810457|Other Pre-specified|Urinalysis||Up to approximately 30 days after last dose of study treatment.|||||||
2551674|NCT02810457|Other Pre-specified|Clinical Chemistry||Up to approximately 30 days after last dose of study treatment.|||||||
2551675|NCT02810457|Other Pre-specified|Hematology||Up to approximately 30 days after last dose of study treatment.|||||||
2551676|NCT02810457|Other Pre-specified|Vital Signs||Up to approximately 30 days after last dose of study treatment.|||||||
2551677|NCT02810457|Other Pre-specified|Adverse Events (AEs)||From the time of signature of informed consent, throughout the treatment period and up to and including the 30-days after the last dose of study treatment, for a total estimated period of time of up to approximately 30 months.|||||||
2551678|NCT02810457|Other Pre-specified|Proportion of Patients Developing Anti-drug Antibodies (ADAs)|The ADA levels were summarized at baseline and post-baseline time points using descriptive statistics.|Pre-dose at Cycles 1, 2, 4 and 6, discontinuation visit, and every 12 weeks (up to 1 year [±14 days] after randomisation) until death, or the patient was lost to follow-up, whichever occurred first.|Includes all patients randomized to treatment who received at least 1 dose of investigational product with no important protocol deviations, and who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result (ADA evaluable population).|||percentage of participants|||Number
2551679|NCT02810457|Other Pre-specified|Serum Trough Concentration (Ctrough)|Ctrough (pre-infusion) and serum maximum concentration (Cmax; at completion of infusion) were compared between treatment arms and time points, and descriptive statistics provided. Ctrough and Cmax concentrations were summarized using the pharmacokinetics (PK) population for each visit at which samples were taken. The pre-dose serum concentrations at Cycles 2, 4, and 6 were considered as Ctrough values and the post-dose serum concentrations at Cycles 1 and 4 were considered as Cmax values. PK data at Cycle 1 Day 1 pre-infusion were not calculable and are therefore not presented in the outcome measure data table. Data are only provided for the time points at which the serum trough concentration was measured.|Cycle 1 Day 1 (pre- and post-infusion), Cycle 2 Day 1 (pre), Cycle 4 Day 1 (pre and post), Cycle 6 Day 1 (pre), discontinuation visit, and every 12 weeks (up to 1 year [±14 days] after randomisation) until death, or the patient was lost to follow-up.|All patients randomized to treatment who received at least 1 dose of investigational product with no important protocol deviations, and at least 1 serum drug concentration data after investigational product administration (PK population).|||ug/ml||Geometric Coefficient of Variation|Geometric Mean
2551715|NCT02809833|Primary|Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 52|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 52 was reported, where negative changes indicated a decrease in physician-assessed disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
2551680|NCT02810457|Secondary|Disease Control Rate (DCR) Assessed as the Proportion of Patients With a BOR of Either CR, PR, SD or NED|The DCR was defined as the proportion of patients defined as responders. The number and percentage of responders and non-responders and the 95% Pearson-Clopper CI of DCR for each treatment arm was provided. The odds ratio for treatment (FKB238 arm versus Avastin arm) and the corresponding 95% Wald CI were produced based on a logistic regression analysis of DCR. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. DCR=CR+PR+SD (≥ 6 weeks).|Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.|This assessment of DCR was based on patients in the ITT population (patients included in each treatment arm as randomized), and the BICR radiological assessments.|||percentage of participants with response||95% Confidence Interval|Number
2551681|NCT02810457|Secondary|Duration Of Response (DOR)|DOR was evaluated in this study as a secondary efficacy endpoint. Only the patients defined as responders in the primary analysis of ORR were taken into account for the analysis of DOR. The event of interest was defined as first documented disease progression or death due to any reason, whichever occurred first. DOR was defined as the interval from the first documented response (as defined per RECIST v1.1) until the earlier date of the first documented disease progression or death due to any reason. The date of first documented response was taken as the date of the first tumor assessment with an overall visit response of CR or PR. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions. DOR was calculated in units of months.|Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.|This assessment of DOR was based on patients with events in the ITT population (patients included in each treatment arm as randomized), and the BICR radiological assessments.|||months||95% Confidence Interval|Median
2551682|NCT02810457|Secondary|Overall Survival (OS)|The event of interest was defined as death from any cause. OS was defined as the interval from date of randomization until the date of death due to any cause. OS was summarized using Kaplan-Meier estimates of the quartiles for each treatment arm, and 95% CIs for the medians were calculated.|Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.|This assessment was performed using the ITT population (patients included in each treatment arm as randomized).|||Months||95% Confidence Interval|Median
2551683|NCT02810457|Secondary|Progression-free Survival (PFS)|The event of interest for PFS was defined as the interval from the date of randomization until first documented disease progression or death from any cause, whichever occurs first. Disease progression was based on tumor assessments according to RECIST v1.1 criteria. The items of the overall response CR, PR, SD and NED were taken as progression-free whereas PD denoted disease progression. PFS was summarized using Kaplan-Meier estimates of the quartiles for each treatment arm, and 95% CIs for the medians were calculated. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: PD=at least a 20% increase in the sum of the longest diameter of target lesions, unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.|Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.|This assessment was performed using the ITT population (patients included in each treatment arm as randomized) and the BICR radiological assessments.|||Months||95% Confidence Interval|Median
2551684|NCT02810457|Secondary|ORR at Week 19|ORR (by RECIST v1.1) at Week 19 was defined as the proportion of patients with a BOR of CR or PR assessed at Week 19. Only tumor assessments performed up until 19 weeks (i.e. Week 18 assessment + 7 day assessment window) from randomization were considered in this analysis. Per RECIST v1.1 for target lesions and assessed by CT or, if contraindicated, MRI: CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions. Overall Response=CR+PR.|From the date of randomization up to Week 19.|In order to meet the FDA requirement, the secondary efficacy analysis of ORR was performed using the ITT population (patients included in each treatment arm as randomized), and the BICR radiological assessments.|||percentage of participants||95% Confidence Interval|Number
2551685|NCT02810457|Primary|Overall Response Rate (ORR) Assessed as the Proportion of Patients With a Best Overall Response (BOR) of Either Complete Response (CR) or Partial Response (PR)|The primary variable in this study was ORR, defined as the proportion of patients with a BOR of CR or PR (by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)). A BOR was defined as the best response (in the order of CR, PR, stable disease (SD), no evidence of disease (NED), progressive disease (PD), and not evaluable (NE)) among all post-baseline disease assessments that occurred until progression, or last evaluable assessment in the absence of progression prior to the initiation of subsequent anti-cancer therapy, irrespective of whether or not patients discontinued the study treatment. The 95% Pearson-Clopper confidence interval (CI) of ORR for each treatment arm was provided. Per RECIST v1.1 for target lesions and assessed by computed tomography (CT) or, if contraindicated, magnetic resonance imaging (MRI): CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions. Overall Response=CR+PR.|Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.|In order to meet the Food and Drug Administration (FDA) requirement, the primary efficacy analysis of ORR was performed using the Intent-to-Treat (ITT) population (patients included in each treatment arm as randomized), and the blinded independent central review (BICR) radiological assessments.|||percentage of participants||95% Confidence Interval|Number
2551686|NCT02810327|Primary|Number of Participants With Abnormal Sequences in SERPINA1 Genes|Additional SERPINA1 variant of known or possible significance detected by next generation sequencing.|End of study NGS Result||||participants|samples||Number
2551768|NCT02809183|Secondary|Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus Placebo|Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the TRC101 6g dose group versus that for Placebo|Baseline and Day 15|Full Analysis Set|||mEq/L||Standard Error|Least Squares Mean
2551687|NCT02809911|Primary|Lower Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli|Response data by induced pain stimuli after the initial treatment with the study device in the upper extremity. The stimuli / test was determined to either favor sham or favor Provant Therapy. This included a total of 20 stimuli/tests (comparing pre-treatment to post initial treatment results) as follows: Cuff Pain Threshold (greater decrease favored), Cuff Pain Tolerance (smaller increase favored), Cuff Pressure Threshold (greater decrease favored), Pressure Tolerance (greater increase favored), Mechanical Pain Threshold (greater decrease favored), Biothesiomety (greater decrease favored) on the forearm, palm, thumb, index finger, middle finger, ring finger and pinky finger, Heat Tolerance (greater decrease favored), Cold Tolerance (greater decrease favored), Pain (greater increase favored), Time to Pain (greater increase favored), Pain Tolerance Grip Strength (greater increase favored) and Final Pain (greater decrease favored). .|4 weeks|Includes subjects in the Initial Treatment Group (Those subjects treated with either Provant or Sham at the Enrollment Visit)|||Number of tests favoring arm/group|||Number
2551688|NCT02809911|Primary|Upper Extremity - Pain Sensitivity to Various Experimentally Induced Pain Stimuli|Response data by induced pain stimuli after the initial treatment with the study device in the upper extremity. The stimuli / test was determined to either favor sham or favor Provant Therapy. This included a total of 20 stimuli/tests (comparing pre-treatment to post initial treatment results) as follows: Cuff Pain Threshold (greater decrease favored), Cuff Pain Tolerance (smaller increase favored), Cuff Pressure Threshold (greater decrease favored), Pressure Tolerance (greater increase favored), Mechanical Pain Threshold (greater decrease favored), Biothesiomety (greater decrease favored) on the forearm, palm, thumb, index finger, middle finger, ring finger and pinky finger, Heat Tolerance (greater decrease favored), Cold Tolerance (greater decrease favored), Pain (greater increase favored), Time to Pain (greater increase favored), Pain Tolerance Grip Strength (greater increase favored) and Final Pain (greater decrease favored).|4 weeks|Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment.|||Number of tests favoring arm/group|||Number
2551689|NCT02809859|Secondary|How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device||6 months||||participants|||Number
2551690|NCT02809859|Primary|Participant Reported Faults, Measured as Number of Participant Complaints||6 months||||complaints|||Number
2551691|NCT02809859|Primary|Machine Reported Faults, Measured as Number of Patients With Machine Faults||6 months||||participants|||Number
2551692|NCT02809859|Primary|Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults||6 months||||participants|||Number
2551693|NCT02809859|Primary|Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour.||6 months||||events/hr||Standard Deviation|Mean
2551694|NCT02809846|Primary|Change in Daily Opioid Use Assessed as Recorded by the Subject in Their Analgesia Diary.|The primary end point of this study was the difference in the change in daily opioid use between the active device group and the sham device group, assessed at weeks 2, 4, 6, 8, and 10 of the study as recorded by the subject in their analgesia diary. Participants documented which medication was taken, how much, and at what time. Dose and type of opioid pain medication was converted to morphine milliequivalents (MME) using conversion factors published by the Centers for Medicare and Medicaid Services (CMS)and combined as a daily dose for each day in a subject's analgesia journal.|Weeks: 2,4,6,8,10||||MME||Standard Deviation|Mean
2551695|NCT02809833|Secondary|Percentage of Participants With AEs Considered Causally Related to Tocilizumab|"An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of tocilizumab. Worsened pre-existing conditions and laboratory or clinical tests that resulted in change or discontinuation of treatment were reported as AEs. The percentage of participants with treatment-related AEs (also known as adverse drug reactions) was reported as a separate endpoint and included both serious and non-serious AEs. Those AEs with a causal relationship reported as definite, probably, possible, or unlikely were considered to be related to tocilizumab. If the causal relationship was reported as unrelated, the AE was considered not related to tocilizumab treatment. Terms were reported verbatim as coded using Medical Dictionary for Regulatory Activities (MedDRA) Version 12.0. The most common treatment-related AEs were reported, using those from the 10 highest incidence rate levels."|Baseline to end of treatment (up to 12 months)|All Enrolled Population|||percentage of participants|||Number
2551696|NCT02809833|Primary|Percentage of Participants With MCII According to DAS28 at Week 52|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 52.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551697|NCT02809833|Primary|Percentage of Participants With MCII According to DAS28 at Week 36|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 36.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551727|NCT02809833|Primary|Change in SJC From Baseline to Week 24|A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||swollen joints||Standard Deviation|Mean
2551698|NCT02809833|Primary|Percentage of Participants With MCII According to DAS28 at Week 24|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 24.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551699|NCT02809833|Primary|Percentage of Participants With Minimum Clinically Important Improvement (MCII) According to DAS28 at Week 12|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. MCII was defined as DAS28 reduction of ≥1.2 points from Baseline to Week 12.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551700|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Week 52|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 52.|Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551701|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Week 36|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 36.|Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551702|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Week 24|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 24.|Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551703|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Week 12|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Week 12.|Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551704|NCT02809833|Primary|Percentage of Participants With Remission According to DAS28 at Baseline|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. Remission was defined as a DAS28 score <2.6 at Baseline.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551705|NCT02809833|Primary|Percentage of Participants With LDAS According to DAS28 at Week 52|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 52.|Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551706|NCT02809833|Primary|Percentage of Participants With LDAS According to DAS28 at Week 36|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 36.|Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551707|NCT02809833|Primary|Percentage of Participants With LDAS According to DAS28 at Week 24|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 24.|Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551708|NCT02809833|Primary|Percentage of Participants With LDAS According to DAS28 at Week 12|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Week 12.|Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551709|NCT02809833|Primary|Percentage of Participants With Low Disease Activity Score (LDAS) According to DAS28 at Baseline|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. LDAS was defined as a DAS28 score ≤3.2 at Baseline.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551710|NCT02809833|Primary|Percentage of Participants With EULAR Response at Week 52|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 52 visit and the DAS28 change from Baseline to Week 52. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551711|NCT02809833|Primary|Percentage of Participants With EULAR Response at Week 36|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 36 visit and the DAS28 change from Baseline to Week 36. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551712|NCT02809833|Primary|Percentage of Participants With EULAR Response at Week 24|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 24 visit and the DAS28 change from Baseline to Week 24. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551713|NCT02809833|Primary|Percentage of Participants With EULAR Response at Week 12|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 12 visit and the DAS28 change from Baseline to Week 12. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551714|NCT02809833|Primary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 4|"Response was determined using EULAR criteria based upon DAS28 absolute scores at the Week 4 visit and the DAS28 change from Baseline to Week 4. Participants with a score less than or equal to (≤) 3.2 and reduction of >1.2 points were assessed as having a Good response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a Moderate response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as non-responders with response recorded as No Improvement."|Baseline to Week 4|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551728|NCT02809833|Primary|Change in SJC From Baseline to Week 12|A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||swollen joints||Standard Deviation|Mean
2551716|NCT02809833|Primary|Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 36|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 36 was reported, where negative changes indicated a decrease in physician-assessed disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
2551717|NCT02809833|Primary|Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 24|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 24 was reported, where negative changes indicated a decrease in physician-assessed disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
2551718|NCT02809833|Primary|Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 12|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 12 was reported, where negative changes indicated a decrease in physician-assessed disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
2551719|NCT02809833|Primary|VAS Score of Physician-Assessed Disease Activity at Baseline|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The VAS score at Baseline was reported.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
2551720|NCT02809833|Primary|Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 52|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 52 was reported, where negative changes indicated a decrease in participant-assessed disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
2551721|NCT02809833|Primary|Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 36|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 36 was reported, where negative changes indicated a decrease in participant-assessed disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
2551722|NCT02809833|Primary|Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 24|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 24 was reported, where negative changes indicated a decrease in participant-assessed disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
2551723|NCT02809833|Primary|Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 12|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The change from Baseline to Week 12 was reported, where negative changes indicated a decrease in participant-assessed disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
2551724|NCT02809833|Primary|VAS Score of Participant-Assessed Disease Activity at Baseline|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity. Higher scores corresponded to increased disease activity (0 mm = no disease activity and 100 mm = maximum disease activity). The VAS score at Baseline was reported.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||mm||Standard Deviation|Mean
2551725|NCT02809833|Primary|Change in SJC From Baseline to Week 52|A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||swollen joints||Standard Deviation|Mean
2551726|NCT02809833|Primary|Change in SJC From Baseline to Week 36|A total of 28 joints were assessed for swollenness. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||swollen joints||Standard Deviation|Mean
2551730|NCT02809833|Primary|Change in TJC From Baseline to Week 52|A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||tender joints||Standard Deviation|Mean
2551731|NCT02809833|Primary|Change in TJC From Baseline to Week 36|A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||tender joints||Standard Deviation|Mean
2551732|NCT02809833|Primary|Change in TJC From Baseline to Week 24|A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||tender joints||Standard Deviation|Mean
2551733|NCT02809833|Primary|Change in TJC From Baseline to Week 12|A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||tender joints||Standard Deviation|Mean
2551734|NCT02809833|Primary|TJC at Baseline|A total of 28 joints were assessed for tenderness. The number of tender joints at Baseline was reported and could range from 0 to 28, where higher values represented more tender joints.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||tender joints||Standard Deviation|Mean
2551735|NCT02809833|Primary|Change in DAS28 From Baseline to Week 52|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 52 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
2551736|NCT02809833|Primary|Change in DAS28 From Baseline to Week 48|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 48 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 48|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
2551737|NCT02809833|Primary|Change in DAS28 From Baseline to Week 44|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 44 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 44|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
2551738|NCT02809833|Primary|Change in DAS28 From Baseline to Week 40|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 40 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 40|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
2551739|NCT02809833|Primary|Change in DAS28 From Baseline to Week 36|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 36 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
2551769|NCT02809183|Secondary|Change From Baseline in Serum Bicarbonate at Day 15 Within the TRC101 6g QD Dose Group|Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline|Baseline and Day 15|Full Analysis Set|||mEq/L||Standard Error|Least Squares Mean
2559652|NCT02674204|Secondary|Change in Peak Left Ventricular Torsion as Measured by CMRI||Baseline to 12 months of follow-up|As accrual fell well below target, change in peak left ventricular torsion as measured by CMRI was not calculated.||||||
2551740|NCT02809833|Primary|Change in DAS28 From Baseline to Week 32|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 32 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 32|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
2551741|NCT02809833|Primary|Change in DAS28 From Baseline to Week 28|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 28 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 28|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
2551742|NCT02809833|Primary|Change in DAS28 From Baseline to Week 24|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 24 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
2551743|NCT02809833|Primary|Change in DAS28 From Baseline to Week 20|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 20 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 20|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
2551744|NCT02809833|Primary|Change in DAS28 From Baseline to Week 16|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 16 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 16|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
2551745|NCT02809833|Primary|Change in DAS28 From Baseline to Week 12|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 12 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
2551746|NCT02809833|Primary|Change in DAS28 From Baseline to Week 8|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 8 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 8|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
2551747|NCT02809833|Primary|Change in DAS28 From Baseline to Week 4|The DAS28 was derived from assessments of ESR, TJC, SJC, and general health according to 100-mm VAS. DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 4 was reported, where negative changes indicated an improvement in disease activity.|Baseline to Week 4|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
2551770|NCT02809183|Secondary|Comparison of the Proportion of Subjects Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Between Each TRC101 Dose Group Versus Placebo|Comparison of the proportion of subjects whose serum bicarbonate values increased from Baseline to Day 15 by greater than or equal to 2, 3, or 4 mEq/L between each TRC101 BID Dose Group versus Placebo|Baseline and Day 15|Full Analysis Set|||Participants|||Count of Participants
2551748|NCT02809833|Primary|28-Joint Disease Activity Score (DAS28) at Baseline|The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR), tender joint count (TJC), swollen joint count (SJC), and general health according to 100-millimeter (mm) Visual Analog Scale (VAS). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of tender joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in millimeters per hour (mm/h). DAS28 scores could range from 0 to 10, where higher scores represented higher disease activity. The score at Baseline was reported.|Baseline|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||units on a scale||Standard Deviation|Mean
2551749|NCT02809833|Primary|Percentage of Participants With Tocilizumab Dose Adjustments by Reason|"The percentage of participants with any tocilizumab dose adjustment during the study was reported among all reasons given for tocilizumab dose adjustments, as provided in the CRF. The sum of all reasons may add up to >100 percent (%) because more than one reason could be given for each dose change. In the table presented, Other Reasons refers to any reason other than those specified in categories. Similarly, Other Laboratory Change refers to a change in any laboratory parameter other than those specified in categories."|Baseline to end of treatment (up to 12 months)|"All Enrolled Population. The Number of Participants Analyzed reflects the number of participants who had at least one tocilizumab dose adjustment during the study."|||percentage of participants|||Number
2551750|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 52."|Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
2551751|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 48."|Week 48|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
2551752|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 44."|Week 44|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
2551753|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 40."|Week 40|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
2551771|NCT02809183|Secondary|Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between the Combined TRC101 Treatment Group Versus Placebo|Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the Combined TRC101 Treatment Group versus that for Placebo|Baseline and Day 15|Full Analysis Set|||mEq/L||Standard Error|Least Squares Mean
2551772|NCT02809183|Secondary|Change From Baseline in Serum Bicarbonate at Day 15 Within the Combined TRC101 Treatment Group|Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline|Baseline and Day 15|Full Analysis Set|||mEq/L||Standard Error|Least Squares Mean
2551754|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 36."|Week 36|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
2551755|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 32."|Week 32|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
2551756|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 28."|Week 28|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
2551757|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 24."|Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
2551758|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 20."|Week 20|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
2551759|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 16."|Week 16|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
2551760|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 12."|Week 12|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
2551761|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values >1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC <0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 8."|Week 8|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
2551762|NCT02809833|Primary|Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4|"SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and platelet count to guide dose decisions. Dose adjustment was recommended in response to ALAT/ASAT values greater than (>) 1 to 3 × ULN. Dose interruption was recommended in response to ALAT/ASAT values >3 to 5 × ULN, ANC of 0.5 to 1 × 10^9 cells/L, or platelet count of 50 to 100 × 10^3 cells/μL, until the values returned to acceptable ranges as per the SmPC. Discontinuation of tocilizumab was recommended for any ALAT/ASAT values >5 × ULN, ANC less than (<) 0.5 × 10^9 cells/L, or platelet count <50 × 10^3 cells/μL. The percentage of participants from each laboratory value category with (Yes) or without (No) tocilizumab dose adjustment or interruption was reported at Week 4."|Week 4|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who had available data for both the specific laboratory parameter and for the possible dose change at the corresponding visit (n) is shown in the table."|||percentage of participants|||Number
2551763|NCT02809833|Primary|Percentage of Participants With Categorized Laboratory Data Available at Week 52|SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific ULN. Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10^9 cells/L for ANC and 50 to 100 × 10^3 cells/μL for platelet count. The percentage of participants with ≥1 documented/evaluable laboratory value at Week 52 was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.|Week 52|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551764|NCT02809833|Primary|Percentage of Participants With Categorized Laboratory Data Available at Week 24|SmPC recommendations were specified in the collection of routine laboratory samples for ALAT, ASAT, ANC, and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific ULN. Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10^9 cells/L for ANC and 50 to 100 × 10^3 cells/μL for platelet count. The percentage of participants with ≥1 documented/evaluable laboratory value at Week 24 was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.|Week 24|"All Enrolled Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percentage of participants|||Number
2551765|NCT02809833|Primary|Percentage of Participants With Categorized Laboratory Data Available at Baseline|SmPC recommendations were specified in the collection of routine laboratory samples for alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), absolute neutrophil count (ANC), and low platelet count to guide dose decisions. Laboratory values for ALAT and ASAT were to be categorized in reference to the institution-specific upper limit of normal (ULN). Laboratory values for ANC and platelet count were to be categorized in reference to a normal range outlined in the SmPC. This range was 0.5 to 1 × 10^9 cells per liter (cells/L) for ANC and 50 to 100 × 10^3 cells per microliter (cells/μL) for platelet count. The percentage of participants with greater than or equal to (≥) 1 documented/evaluable laboratory value at Baseline was reported, along with the percentage of participants with categorized laboratory data available for each individual parameter.|Baseline|All Enrolled Population.|||percentage of participants|||Number
2551766|NCT02809183|Secondary|Comparison of the Proportion of Subjects in the TRC101 6g QD Dose Group Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Versus Placebo|Comparison of the proportion of subjects whose serum bicarbonate values increased from Baseline to Day 15 by greater than or equal to 2, 3, or 4 mEq/L between the 6g TRC101 QD Dose Group versus Placebo|Baseline and Day 15|Full Analysis Set|||Participants|||Count of Participants
2551767|NCT02809183|Secondary|Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus the TRC101 3g BID Dose Group|Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the TRC101 6g QD dose group versus that for the TRC101 3g BID dose group|Baseline and Day 15|Full Analysis Set|||mEq/L||Standard Error|Least Squares Mean
2551775|NCT02809183|Primary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE|The number and percentage of subjects who reported treatment-emergent adverse events (TEAEs) summarized by system organ class and preferred term (see Reported Adverse Events) as well as by severity, causality, seriousness, and action taken with regard to study drug. All analyses were descriptive.|Through treatment period completion (Day 15)|Safety Analysis Set|||Participants|||Count of Participants
2551776|NCT02808390|Primary|Efficacy on Ulcerative Colitis Disease Activity Index|After 17 months, only 19 patients out of the target 207 patients, were enrolled in the study. Therefore neither descriptive nor comparative analyses were performed on outcome measures and the project in mild to moderate ulcerative colitis has been terminated.|up to 8 Weeks|After 17 months, only 19 patients out of the target 207 patients, were enrolled in the study. Therefore neither descriptive nor comparative analyses were performed on outcome measures and the project in mild to moderate ulcerative colitis has been terminated||||||
2551777|NCT02808338|Primary|Average Apnea Hypopnea Index Among Different Polysomnography Devices.|The Apnea Hypopnea Index is the number of the apneas and hypopneas during one hour of sleep. The average of these events over one night were compared during each overnight device use.|4 nights|1 participant was excluded because he did not meet the criteria to receive ASV.|||events per hour||Standard Deviation|Mean
2551778|NCT02808130|Primary|Total Antioxidant Capacity Levels in Gingival Crevicular Fluid as a Marker of Antioxidant Status|Contrary to oxidant mediators, TAOC provides an extensive overview of the antioxidant status of the individuals and how well these antioxidants are able to protect host cells during periods of oxidative stress. Due to the potential synergistic effects of different antioxidant molecules, the measurement of TAOC can provide a more accurate and extensive assessment of antioxidant status rather than the separate measurement of individual antioxidant molecules|8-10 am on the day following periodontal status assessment.||||pg/ml||Standard Error|Mean
2551779|NCT02808130|Primary|Protein Carbonyl Level in Gingival Crevicular Fluid as a Marker of Protein Oxidation|Protein carbonylation is another nonenzymatic oxidative post-translational modification and assesed by protein carbonyl tissue content that is often used as a biomarker of oxidative stress.|8-10 am on the day following periodontal status assessment.||||pg/ml||Standard Error|Mean
2551780|NCT02808130|Primary|Gingival Crevicular Fluid Level of Malondialdehyde (MDA) as a Marker of Lipid Oxidation.|Malondialdehyde levels in gingival crevicular fluid as measured an oxidative stress marker in lipid. Malondialdehyde (MDA) is the most specific and the most often used molecule in the measurement of biological lipid oxidation|8-10 am on the day following periodontal status assessment.||||pg/ml||Standard Error|Mean
2551781|NCT02808052|Primary|Safety and Tolerability of Intravenous Dose(s) of Minocin (Minocycline) for Injection Assessed by Number of Subjects With Adverse Events|Safety and Tolerability: Subjects with mild, moderate, or severe renal insufficiency with any adverse events, any serious adverse events, any study related adverse events, and any adverse events with a fatal outcome.|Approximately 24 weeks|All subjects (9) subjects who received at least one dose of study drug were included in the safety population used for safety analyses.|||Participants|||Count of Participants
2551782|NCT02807948|Primary|The Proportion of MRI Scans From ICDs or CRT-Ds Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.|Based on the ability of the radiologist to read and provide a diagnosis/report.|1 month|Proportion of MRI scans from ICDs or CRT-Ds providing sufficient image quality for diagnostic interpretation|||MRI Scans|MRI Scans||Count of Units
2551783|NCT02807948|Primary|The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.|Based on the ability of the radiologist to read and provide a diagnosis/report.|1 month|Proportion of MRI scans from CRT-Ps or Pacemakers providing sufficient image quality for diagnostic interpretation|||MRI Scans|MRI Scans||Count of Units
2551784|NCT02807402|Secondary|Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies||From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen). The over all median (minimum, maximum) duration of treatment was 84 (28, 175) days.|All enrolled participants who received at least one dose of paritaprevir/ritonavir and ombitasvir with or without dasabuvir.|||Participants|||Count of Participants
2551785|NCT02807402|Secondary|Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)|The BMQ consists of 2 sections and 18 questions to screen for patients' beliefs, attitudes and concerns about their medication. The BMQ-Specific section comprises two 5-item subscales assessing the necessity of and concerns about the prescribed medication (Specific-Necessity and Specific-Concerns). The BMQ-General section comprises two 4-item subscales assessing beliefs that medicines are harmful and overused by doctors in general (General-Harm and General-Overuse). The 18 items are rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Each subscale score ranges from 1 to 5. High scores in the Specific-Concerns scale represent the notion that adverse reactions are potentially harmful when taking medication on a regular basis, and high scores in the Specific-Necessity scale indicate the patient's need to adhere to medication to maintain health. High scores in the General-Harm and General-Overuse scales represent an overall negative perception of medication.|Baseline and end of treatment (week 12 or 24 depending on the treatment regimen)|Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) with available data at baseline and end of treatment.|||units on a scale||95% Confidence Interval|Least Squares Mean
2551786|NCT02807402|Secondary|Change From Baseline in Patient Activation Measure 13 (PAM-13)|"PAM 13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. Each of the 13 items can be answered with one of four possible response options, which are disagree strongly (1), disagree (2), agree (3), agree strongly (4). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating higher patient activation"|Baseline and end of treatment (week 12 or 24 depending on the treatment regimen)|Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) with available data at baseline and end of treatment.|||units on a scale||95% Confidence Interval|Least Squares Mean
2551787|NCT02807402|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment|"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems."|Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) with available data at baseline and each time point.|||percent impairment||Standard Deviation|Mean
2551788|NCT02807402|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)|"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total work productivity impairment (TWP) indicates the percentage of overall work impairment due to health problems."|Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). Participants who were employed with available data at baseline and each time point are included.|||percent impairment||Standard Deviation|Mean
2551789|NCT02807402|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism|"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Presenteeism indicates the percentage of impairment while working due to health problems."|Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). Participants who were employed with available data at baseline and each time point are included.|||percent impairment||Standard Deviation|Mean
2551790|NCT02807402|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism|"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Absenteeism indicates the percentage of work time missed due to health problems."|Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). Participants who were employed with available data at baseline and each time point are included.|||percent impairment||Standard Deviation|Mean
2551791|NCT02807402|Secondary|Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score|"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. with a separate visual analog scale (VAS).~The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable)."|Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) and with available data at baseline and each time point.|||units on a scale||95% Confidence Interval|Least Squares Mean
2551792|NCT02807402|Secondary|Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score|"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS).~Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status."|Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) and with available data at baseline and each time point.|||units on a scale||95% Confidence Interval|Least Squares Mean
2551793|NCT02807402|Secondary|Number of Participants Who Received Concomitant Medications|Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir until after the last dose.|From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen|Enrolled patients who received at least one dose of paritaprevir/ritonavir and ombitasvir with or without dasabuvir.|||Participants|||Count of Participants
2551794|NCT02807402|Secondary|Number of Participants With Comorbidities||Baseline|Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||Participants|||Count of Participants
2559653|NCT02674204|Secondary|Change in Peak Left Ventricular Twist as Measured by CMRI||Baseline to 12 months of follow-up|As accrual fell well below target, change in peak left ventricular twist as measured by CMRI was not calculated.||||||
2551795|NCT02807402|Secondary|Percentage of Ribavirin (RBV) Treatment Days in Relation to the Target Number of Ribavirin Treatment Days||From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.|Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype), who were prescribed ribavirin.|||percentage of days||Standard Deviation|Mean
2551796|NCT02807402|Secondary|Percentage of the Ribavirin Dose Taken in Relation to the Target Dose of Ribavirin|"Adherence to study treatment was calculated as:~Cumulative dose taken / (initial prescribed dose * planned duration)"|From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen|Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype), who were prescribed ribavirin, and with available data.|||Participants|||Count of Participants
2551797|NCT02807402|Secondary|Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA|"Adherence to study treatment was calculated as:~Cumulative dose taken / (initial prescribed dose * planned duration)"|From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.|Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||Participants|||Count of Participants
2551798|NCT02807402|Secondary|Assigned Treatment Regimen|Treatment regimen was assigned by the physician according to local practice and label. Participants could receive three direct-acting antiviral (DAA) drugs (paritaprevir/ritonavir, ombitasvir, and dasabuvir) with or without RBV for 12 or 24 weeks.|Baseline|Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||Participants|||Count of Participants
2551799|NCT02807402|Secondary|Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment|"SVR12 non-response was categorized according to the following:~On-treatment virologic failure (breakthrough [at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥ 50 IU/mL]);~Relapse, defined as HCV RNA < 50 IU/mL at EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened);~Death;~Premature treatment discontinuation with no on-treatment virological failure;~Missing SVR12 data and/or none of the above criteria."|12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)|Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants|||Number
2551800|NCT02807402|Secondary|Percentage of Participants With Breakthrough|Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.|12 or 24 weeks (depending on the treatment regimen)|Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) with virological response on-treatment and with at least one on-treatment measurement (including EOT) thereafter.|||percentage of participants||95% Confidence Interval|Number
2551801|NCT02807402|Secondary|Percentage of Participants With Relapse|Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.|End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.|Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics, and with VR at EOT and who completed treatment, and had ≥ 1 HCV RNA measurement ≥ 70 days post-treatment and were a treatment failure between EOT and post-treatment day 70.|||percentage of participants||95% Confidence Interval|Number
2551802|NCT02807402|Secondary|Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment|"Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.~The core population with sufficient follow-up data regarding SVR12 included all core population participants who~had evaluable HCV RNA data ≥ 70 days after the last actual dose of paritaprevir/ritonavir, ombitasvir and dasabuvir~or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline~or had HCV RNA < 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 70 days after the last actual dose of paritaprevir/ritonavir, ombitasvir with dasabuvir due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure."|12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)|Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype), and with sufficient follow-up data regarding SVR12.|||percentage of participants||95% Confidence Interval|Number
2551803|NCT02807402|Secondary|Percentage of Participants Achieving Virological Response at End of Treatment|Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.|End of treatment (week 12 or 24 depending on the treatment regimen)|Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants||95% Confidence Interval|Number
2551804|NCT02807402|Primary|Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)|Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.|12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)|Enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). Three participants with genotype 1 prescribed paritaprevir/r and ombitasvir instead of paritaprevir/r, ombitasvir and dasabuvir (3DAA) were excluded.|||percentage of participants||95% Confidence Interval|Number
2551824|NCT02806960|Primary|PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon||Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment|Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose.||||||
2551805|NCT02807376|Secondary|Proportion of Participants Requiring Post-operative Interventions or Procedures Related to Renal Artery or Renal Vein Bleeding|"Proportion of participants with hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the Renal Artery and Renal Vein during laparoscopic nephrectomy or nephroureterectomy with the use of SOC or PVS:~Hemostasis intervention: bleeding that occurs post-operatively requiring blood or blood product transfusion or an additional surgical procedure (related to Renal Artery and Renal Vein transection).~No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection)."|Post-Op through 4 Week Follow-up|All randomized subjects in whom the Standard of Care or Powered Vascular Stapler was used for vessel transection.|||proportion of participants||95% Confidence Interval|Number
2551806|NCT02807376|Primary|Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions|Proportion of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Reanl Artery and Renal Vein during laparoscopic nephrectomy or nephroureterectomy with the use of standard of care stapler (SOC) or powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open).|Intra-Operative, an average of 2.6 hours, ranging from 42 minutes to 6.4 hours|All randomized subjects in whom the Standard of Care or Powered Vascular Stapler was used for vessel transection.|||proportion of transected vessels|Vessels Transected|95% Confidence Interval|Number
2551807|NCT02807259|Secondary|Changes in Solidarity Among FSWs Around Violence|Change in proportion of FSWs who support their peers to reduce incidences of violence among FSWs|27 months after implementing the intervention||||Participants|||Count of Participants
2551808|NCT02807259|Secondary|Changes in Self-efficacy|Proportion of FSWs who report ability to negotiate condom use and HIV/STI testing by their IP|27 months after implementing the intervention||||Participants|||Count of Participants
2551809|NCT02807259|Secondary|Change in Disclosure of Violence From Intimate Partners|Change in proportion of FSWs who are willing to disclose incidences of violence by their intimate partner|27 months after implementing the intervention||||Participants|||Count of Participants
2551810|NCT02807259|Secondary|Changes in Acceptance of Violence|Change in the proportion of FSWs who report violent actions from intimate partners to be unacceptable|27 months after implementing the intervention||||Participants|||Count of Participants
2551811|NCT02807259|Primary|Condom Use|Proportion of sex workers who report consistent condom use in their intimate relationship in the last 30 days|27 months after implementing the intervention||||Participants|||Count of Participants
2551812|NCT02807259|Primary|Severe Intimate Partner Violence|Proportion of sex workers experienced severe physical and/or sexual violence from intimate partners in the past 6 months|27 months after implementing the intervention||||Participants|||Count of Participants
2551813|NCT02807259|Primary|Intimate Partner Violence|Proportion of FSWs who report experiencing any intimate partner violence in the last 6 months|27 months after implementing the intervention||||Participants|||Count of Participants
2551814|NCT02806973|Other Pre-specified|PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Glucagon||-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration|All enrolled participants with evaluable PK data.|||pg*hr/mL||Standard Deviation|Mean
2551815|NCT02806973|Primary|PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax)||-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration|All enrolled participants with evaluable PD data.|||mmol/L||Standard Deviation|Mean
2551816|NCT02806973|Primary|PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose||-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration|All enrolled participants with evaluable PD data.|||Hour (hr)||Full Range|Median
2551817|NCT02806973|Primary|Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC0-3) of Baseline-Adjusted Glucose From Time Zero up to 3 Hours||-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration|All enrolled participants with evaluable PD data.|||Hour*millimoles per liter(hr*mmol/L)||Standard Deviation|Mean
2551818|NCT02806973|Primary|PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon||-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration|All enrolled participants with evaluable PK data.|||picograms per millilitre (pg/mL)||Standard Deviation|Mean
2551819|NCT02806973|Primary|PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon||-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration|All enrolled participants with evaluable PK data.|||Hour (hr)||Full Range|Median
2551820|NCT02806973|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T(AUC[0-tlast]) of Baseline-Adjusted Glucagon||-0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration|All enrolled participants with evaluable PK data.|||picogram*hour per millilitre (pg*hr/mL)||Standard Deviation|Mean
2551821|NCT02806960|Primary|PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax)||Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment|Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose.||||||
2551822|NCT02806960|Primary|PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose||Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment|Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose.||||||
2551823|NCT02806960|Primary|Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC₀₋₁.₅) of Blood Glucose (BG)||Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, and 1.5 hours post dose for each treatment|Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose.||||||
2552653|NCT02791763|Secondary|Number of ND Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks|Number of ND participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented.|Up to week 52|ITT Population|||Participants|||Count of Participants
2551825|NCT02806960|Primary|PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon||Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment|Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose.||||||
2551826|NCT02806960|Primary|PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon||Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment|Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose.||||||
2551827|NCT02806960|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon||Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment|Zero participants analyzed due to the limited number of samples and the delivery of a potential sub-target dosing dose.||||||
2551828|NCT02806947|Secondary|Percentage of Participants With Serious Infections|The cumulative incidence of serious infections (Grade 2 or 3 per BMT CTN MOP) is described, with death treated as a competing risk.|6 and 12 Months Post-randomization||||percentage of participants||95% Confidence Interval|Number
2551829|NCT02806947|Secondary|Percentage of Participants With GVHD-free Survival|GVHD-free survival is defined as freedom from acute GVHD, chronic GVHD, and death. The proportion of participants alive and free of both acute and chronic GVHD are described at 6 and 12 months post-randomization.|6 and 12 Months Post-randomization|GVHD-free survival was evaluated only in participants that remained on study until the assessment time point. One participant on the prednisone arm and five on the sirolimus arm were excluded from the analysis at 6 and 12 months due to prior study withdrawal.|||percentage of participants||95% Confidence Interval|Number
2551830|NCT02806947|Secondary|Percentage of Participants With Chronic GVHD|Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification. The cumulative incidence of chronic GVHD is described, with death and malignancy relapse treated as competing risks.|6 and 12 Months Post-randomization||||percentage of participants||95% Confidence Interval|Number
2551831|NCT02806947|Secondary|Percentage of Participants With Malignancy Relapse|The cumulative incidence of relapse of the primary malignancy is described, with death treated as a competing risk.|6 and 12 Months Post-randomization||||percentage of participants||95% Confidence Interval|Number
2551832|NCT02806947|Secondary|Percentage of Participants With Non-relapse Mortality|Non-relapse mortality is defined as death due to any cause other than relapse of the underlying malignancy. The cumulative incidence of non-relapse mortality is described, with malignancy relapse treated as a competing risk.|6 and 12 Months Post-randomization||||percentage of participants||95% Confidence Interval|Number
2551833|NCT02806947|Secondary|Proportion of Participants With Event-free Survival|Event-free survival is defined as freedom from acute GVHD progression, chronic GVHD, malignancy relapse, and death.|6 and 12 Months Post-randomization||||percentage of participants||95% Confidence Interval|Number
2551834|NCT02806947|Secondary|Percentage of Participants With Disease-free Survival|Disease-free survival is defined as freedom from death and relapse of the underlying malignancy.|6 and 12 Months Post-randomization||||percentage of participants||95% Confidence Interval|Number
2551835|NCT02806947|Secondary|Percentage of Participants With Overall Survival|Overall survival is defined as survival of death from any cause.|6 and 12 Months Post-randomization||||percentage of participants||95% Confidence Interval|Number
2551836|NCT02806947|Secondary|Percentage of Participants With Treatment Failure|"Treatment failure is defined as either no response (NR) or progression and scored by comparison to acute GVHD status at randomization. Progression is defined as worsening in some target organ(s) without improvement in others and NR is defined as absence of any improvement or worsening in target organs. Death and initiation of systemic acute GVHD treatment beyond randomized treatment are classified as NR. Organ staging is defined as:~Skin stage:~0: No rash~Rash <25% of body surface area (BSA)~Rash 25-50% of BSA~Rash >50% of BSA~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level in mg/dL):~0: <2~2-3~3.01-6~6.01-15.0~>15~GI stage:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus"|Days 28 and 56 Post-randomization|Treatment failure was evaluated in participants remaining on study until the assessment day. At Day 28, one prednisone and four sirolimus arm participants were excluded from the analysis due to prior study withdrawal. At Day 56, one prednisone and five sirolimus arm participants were excluded from the analysis due to prior study withdrawal.|||Participants|||Count of Participants
2551837|NCT02806947|Secondary|Acute GVHD Response|"Acute GVHD response is classified as CR, PR, mixed response (MR), no response (NR), and progression and scored by comparison to acute GVHD status at randomization. MR is defined as improvement in some organ(s) with worsening in another, progression as worsening in some organ(s) without improvement in others, and NR as absence of any improvement or worsening. Death and initiation of systemic acute GVHD treatment beyond randomized treatment are classified as NR. Organ staging is defined as:~Skin stage:~0: No rash~Rash <25% of body surface area (BSA)~Rash 25-50% of BSA~Rash >50% of BSA~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level in mg/dL):~0: <2~2-3~3.01-6~6.01-15.0~>15~GI stage:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus"|Days 28 and 56 Post-randomization|Acute GVHD response was evaluated in participants remaining on study until the assessment day. At Day 28, one prednisone and four sirolimus arm participants were excluded from the analysis due to prior study withdrawal. At Day 56, one prednisone and five sirolimus arm participants were excluded from the analysis due to prior study withdrawal.|||Participants|||Count of Participants
2551848|NCT02806544|Secondary|Pathologic Complete Response|Pathologic complete response was defined as no residual tumor at the primary site or the axillary lymph nodes at the time of surgery.|4-6 months|This Outcome Measure was only assessed among patients who had undergone surgery.|||participants|||Number
2552654|NCT02791763|Secondary|Percentage of PD Participants Who Had an Hgb Level of Less Than 7.5 g/dL|Percentage of PD participants who had an Hgb level of less than 7.5 g/dL is presented.|Up to week 52|Efficacy PD Population|||Percentage of participants|||Number
2551838|NCT02806947|Secondary|Percentage of Participants With Complete or Partial Response (CR/PR) and Steroid Dose Less Than 0.25 mg/kg Per Day|"The proportion of patients with CR/PR and on a prednisone-equivalent steroid dose of 0.25 mg/kg/day or less is evaluated. CR/PR scoring is in comparison to acute GVHD status at randomization. CR is defined as staging of 0 in all target organs. PR is defined as improvement in some organ(s) without worsening in others. Death and initiation of steroid-free, systemic acute GVHD treatment beyond randomized therapy are considered failures for this endpoint. Organ staging is defined as:~Skin stage:~0: No rash~Rash <25% of body surface area (BSA)~Rash 25-50% of BSA~Rash >50% of BSA~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level in mg/dL):~0: <2~2-3~3.01-6~6.01-15.0~>15 mg/dL~GI stage:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus"|Day 28 Post-randomization|The endpoint was evaluated only in participants that remained on study until Day 28. One participant on the prednisone arm and four on the sirolimus arm were deemed unevaluable at Day 28 due to prior study withdrawal.|||Participants|||Count of Participants
2551839|NCT02806947|Primary|Percentage of Participants With Complete or Partial Response (CR/PR) to Acute GVHD Treatment|"Scoring of CR/PR is in comparison to the participant's acute GVHD status at randomization. Complete response (CR) is defined as staging of 0 for in all target organs for GVHD - skin, GI tract, and liver. Partial response (PR) is defined as improvement in some target organ(s) without worsening in others. Death and initiation of systemic acute GVHD treatment beyond randomized treatment are considered failures for this endpoint. Organ staging is defined below:~Skin stage:~0: No rash~Rash <25% of body surface area (BSA)~Rash on 25-50% of BSA~Rash on >50% of BSA~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level):~0: <2 mg/dL~2-3 mg/dL~3.01-6 mg/dL~6.01-15.0 mg/dL~>15 mg/dL~GI stage:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus"|Days 28 and 56 Post-randomization|CR/PR was evaluated in participants remaining on study until the assessment time point. At Day 28, one prednisone and four sirolimus arm participants were excluded from the analysis due to prior study withdrawal. At Day 56, one prednisone and five sirolimus arm participants were excluded from the analysis due to prior study withdrawal.|||Participants|||Count of Participants
2551840|NCT02806869|Secondary|Average Area Under the Plasma Concentration-time Curve (AUC) in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen|The plasma concentration of ibuprofen was measured at multiple timepoints over a 24 hour period. The reported value represents the mean and standard deviation of AUC over this time frame.|from time 0 to 24 hours|Overall Number of Participants Analyzed equals the number of participants who completed the First intervention plus the number of participants who completed the Second Intervention. For Arm #1: Overall Number of Participants Analyzed=13+7=20. For Arm #2: Overall Number of Participants Analyzed=12+5=17.|||h*mg/L||Standard Deviation|Mean
2551841|NCT02806869|Secondary|Maximum Duodenal Fluid Concentration of Ibuprofen in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen|The concentration of duodenal fluid was measured at multiple timepoints over a 7 hour period. The reported value represents the mean and standard deviation maximum concentration measured in duodenal fluid.|from time 0 to 7 hours|Overall Number of Participants Analyzed equals the number of participants who completed the First intervention plus the number of participants who completed the Second Intervention. For Arm #1: Overall Number of Participants Analyzed=13+7=20. For Arm #2: Overall Number of Participants Analyzed=12+5=17.|||mg/L||Standard Deviation|Mean
2551842|NCT02806869|Primary|Average Duodenal Fluid pH in Fasted Compared to Fed Participants Administered a Single Dose of Ibuprofen|The pH of duodenal fluid was measured at multiple timepoints over a 7 hour period. The reported value represents the mean and standard deviation of duodenal fluid pH.|from time 0 to 7 hours|Overall Number of Participants Analyzed equals the number of participants who completed the First intervention plus the number of participants who completed the Second Intervention. For Arm #1: Overall Number of Participants Analyzed=13+7=20. For Arm #2: Overall Number of Participants Analyzed=12+5=17.|||pH||Standard Deviation|Mean
2551843|NCT02806726|Secondary|Monocular Distance Corrected Near Visual Acuity (DCNVA) AT 40 cm|Mean distance corrected near visual acuity (DCNVA) for PresbyT-LASIK treatments (test) was compared to iDesign CustomVue treatments (control).|6 months|Due to the small sample size, descriptive results for all endpoints are provided along with confidence intervals, and no statistical conclusions are made.|||LogMar|Eyes|95% Confidence Interval|Mean
2551844|NCT02806726|Primary|Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm|Mean distance corrected intermediate visual acuity (DCIVA) for presbyT-LASIK treatments (test) was compared to iDesign CustomVue treatments (control).|6 months|Due to the small sample size, descriptive results for all endpoints are provided along with confidence intervals, and no statistical conclusions are made.|||LogMAR|Eyes|95% Confidence Interval|Mean
2551845|NCT02806713|Secondary|Change in Participant-reported Pain From Pre to Post Procedure Using the Visual Analog Scale (VAS)|"To determine if the phenazopyridine has an analgesic effect after the retropubic midurethral slings, participants will be asked to self-report pain intensity preoperatively and then postoperatively (2 to 3 hours post procedure) using the Visual Analog Scale (VAS). The scale of the VAS is from 0 meaning no pain to 10 indicating the worst pain. The resulting change is measured as the difference between the self-reported preoperative pain score and the postoperative pain score."|Preoperatively and then 2 to 3 hours after surgery||||score on a scale||Standard Deviation|Mean
2551846|NCT02806713|Primary|Percentage of Participants With a Failed Voiding Trial|Number of participants with a failed postoperative voiding trial. A failed voiding trial is defined as not voiding all urine in 20 minutes or voiding less than 1/3 of total volume (voided volume + post void residual). Patients will undergo voiding trial at same day surgery per the following protocol. Participants who do not pass the voiding trial the same day of their surgical procedure return to the clinic in 3 days to repeat it, following the same protocol described above.|Postoperatively, up to 3 days after surgery||||Participants|||Count of Participants
2551847|NCT02806544|Secondary|Breast Conserving Therapy|"The rate of breast conservation surgery (as opposed to mastectomy) after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be responders to neoadjuvant tamoxifen (Ki67 < or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy)."|4-6 months|This outcome measure was analyzed in patients who were treated with 4 months of neoadjuvant tamoxifen|||participants|||Number
2551849|NCT02806544|Secondary|Overall Clinical Response Rate|Clinical response rate was assessed by palpation after 4 months of tamoxifen. Complete response was defined as no palpable primary tumor on clinical examination and lymph nodes < 10 mm. Partial response was defined as at least 30% decrease in the sum of the diameters compared to baseline sum of diameters. The overall clinical response was the sum of the complete clinical response and partial clinical response.|4-6 months|This Outcome Measure was only assessed among patients undergoing surgery and is a unique outcome measure.|||participants|||Number
2551850|NCT02806544|Secondary|Ki67 Suppression Rate at 4-6 Weeks in Patients Who Underwent an On-treatment Biopsy|Result is the number of participants who had Ki67 suppression (< or = 10%) after 4-6 weeks of neoadjuvant tamoxifen out of patients who underwent an on-treatment biopsy.|4-6 weeks|32 of the 35 patients underwent an on-treatment biopsy; 3 patients did not follow-up and were not included in the number of participants analyzed for this measure.|||participants|||Number
2551851|NCT02806544|Secondary|Number of Participants With Definitive Surgery in Responders to Neoadjuvant Tamoxifen|"Rate of definitive surgery after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be responders to neoadjuvant tamoxifen (Ki67 < or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy)"|4-6 months||||participants|||Number
2551852|NCT02806544|Primary|Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility|Feasibility is defined as the ability to recruit the stated number of patients and fifty percent of participants completing the trial. Completing the trial is defined as reaching surgery if they are a responder to tamoxifen or obtaining the six week biopsy specimen if they are a non-responder.|4-6 months|The number of patients analyzed was the accrual goal for number of participants and the outcome measure was the actual number of participants accrued. The outcome measure time frame is the maximum time each participant would be on study.|||participants|||Number
2551853|NCT02806505|Secondary|Percentage of Participants With Virological Response (at Least a 2-log 10 Decrease in HCV RNA as Compared With Baseline or Unquantifiable [Less Than {<} 600 International Unit/Milliliter {IU/mL}] or Undetectable HCV RNA [< 50 IU/mL]) at Week 12 and 24|Virological response at Weeks 12 and 24 was computed as the percentage of participants with at least a 2-log 10 decrease in HCV RNA at Weeks 12 and 24 as compared with baseline or with an unquantifiable (< 600 IU/mL) or an undetectable HCV RNA test result (< 50 IU/mL) at Week 12 and at Week 24, calculated as the number of participants meeting this criterion divided by the number of participants of the respective participant population.|Weeks 12 and 24|The ITT analysis population included all the randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2551854|NCT02806505|Secondary|Percentage of Participants With Virological Response (Non-detectable Hepatitis C Virus-ribonucleic Acid [HCV RNA]) at End of Treatment (EOT)|Virological response at the end of study treatment was defined as the percentage of participants with undetectable HCV RNA. This response rate at end of treatment was calculated as the number of participants with undetectable HCV RNA divided by the number of participants of the respective participant population.|EOT (Week 48)|The ITT analysis population included all the randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2551855|NCT02806505|Primary|Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment|SVR was defined as the percentage of patients with undetectable HCV RNA. SVR rate was calculated as the number of participants with an undetectable HCV RNA divided by the number of participants of the respective participant population. The last single HCV RNA less than (<) 50 international units per millilitre (IU/mL) measured >=140 days after treatment end (i.e., >= 20 weeks after treatment end) was used to determine SVR. Participants without measurements in this time window were considered to be nonresponders.|24 weeks after end of treatment (Week 72)|The ITT analysis population included all the randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2551856|NCT02806232|Secondary|Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test|Clinical Cure defined as no parasite eggs in the stools as assessed by the commercially available POC-CCA assay for S. mansoni. Number of participants with clinical cure were reported.|Day 2, Day 8 and 14-21 days post treatment|mITT analysis set included all participants who had a baseline measurement for the efficacy variable and did not use anti-malaria treatment after study treatment.|||Participants|||Count of Participants
2551857|NCT02806232|Secondary|Egg Reduction Rate (Percent)|Percent reduction in egg count was calculated as geometric mean egg count at post-treatment minus geometric mean egg count at baseline (before treatment) divided by geometric mean egg count at baseline.|Baseline, 14-21 days post treatment|mITT analysis set included all participants who had a baseline measurement for the efficacy variable and did not use anti-malaria treatment after study treatment.|||percent reduction in egg count||95% Confidence Interval|Geometric Mean
2551858|NCT02806232|Primary|Number of Participants With Clinical Cure Determined by Kato-Katz Method|Clinical cure was defined as zero egg counts at 14-21 days post treatment as determined by the Kato-Katz method. Number of participants with clinical cure were reported.|14-21 days post treatment|Modified intention-to-treat (mITT) analysis set included all participants who had a baseline measurement for the efficacy variable and did not use anti-malaria treatment after study treatment.|||Participants|||Count of Participants
2551859|NCT02806024|Secondary|Blood Transfusion (Number of Units Transfused) Intraoperatively|Total number of units of blood transfused (whole blood, platelets, cryoprecipitate, and fresh frozen plasma) intra-operatively is a secondary outcome.|Pulled from operative note, completed by the time of discharge.|The mean pRBCs units given intraoperatively is presented in the table below.|||units||Standard Deviation|Mean
2551860|NCT02806024|Primary|Estimated Blood Loss (EBL)|EBL is estimated by the surgeon and anesthesia team at the completion of the surgery (cesarean delivery &/or cesarean hysterectomy).|1-3 hours (will be determined at the completion of the surgery).|Mean estimated blood loss (EBL) was calculated as below.|||cc||Standard Deviation|Mean
2551861|NCT02805907|Secondary|Quality of Life Measured With Mini-AQLQ (Asthma Quality of Life Questionnaire)|Mini-AQLQ (Asthma Quality of Life Questionnaire): The response options for each item are placed on an equidistant 7-point scale, where 1 = maximum limitation and 7 = no limitation. The questionnaire Global score, which is the mean for all 15 items that make up the scale, and a score for each dimension, which is the average of the corresponding items for that dimension.|6 months||||units on a scale||Standard Deviation|Mean
2551862|NCT02805907|Secondary|Dose Inhaled Corticosteroids as the Scale of the Spanish Guide for Asthma Management (GEMA 4.0)|"Dose inhaled corticosteroids as the scale of the Spanish guide for asthma management (GEMA 4.0): Depends on the type of steroids:~Beclomethasone dipropionate (Low dose: 200-500 mcg/day, Half dose: 501-1000 mcg/day, High dose: 1001-2000 mcg/day), Beclomethasone extrafine (Low dose: 100-200 mcg/day, Half dose: 201-400 mcg/day, High dose: > 400 mcg/day), Budesonide (Low dose: 200-400 mcg/day, Half dose: 401-800 mcg/day, High dose: 801-1600 mcg/day), Ciclesonide (Low dose: 80-160 mcg/day, Half dose: 161-320 mcg/day, High dose: 321-1280 mcg/day), Fluticasone furoate (Half dose: 92 mcg/day, High dose: 184 mcg/day), Fluticasone propionate (Low dose: 100-250 mcg/day, Half dose: 251-500 mcg/day, High dose: 501-1000 mcg/day), Mometasone furoate (Low dose: 100-200 mcg/day, Half dose: 201-400 mcg/day, High dose: 401-800 mcg/day),"|6 months||||Participants|||Count of Participants
2551863|NCT02805907|Secondary|Number of Asthma Exacerbations|Number of asthma exacerbations during the study period|6 months||||Asthma exacerbations||Standard Deviation|Mean
2551864|NCT02805907|Primary|Asthma Control Measured With Asthma Control Test (ACT)|Asthma Control Test (ACT): Interpretation of the ACT questionnaire: Score less than or equal to 15 points: poor control; Between 16 and 19 points: partially controlled; Greater or equal to 20 points: good control.|6 months||||units on a scale||Standard Deviation|Mean
2551865|NCT02805647|Primary|Vitamin D Status; VDR Status|Serum concentrations of total vitamin D; VDR polymorphism test|We measured Vitamin D status at the time of admission - at the time of fracture|Children from Poland Podlasie region|||ng/ml||Inter-Quartile Range|Mean
2551866|NCT02804750|Post-Hoc|Percentage of Participants With IGT / T2DM Who Experienced Improvement in Glucose Control Following Treatment With CORT125134: Responder Definition Based on Response Criteria for Phase 3 Study NCT03697109|Improvement in glucose control was defined based on response criteria for Phase 3 study NCT03697109: a participant who experiences 1) a hemoglobin A1c (HbA1c) that is decreased by ≥ 0.5% from baseline, 2) a 2-hour oGTT plasma glucose that is normalized (< 7.8 mmol/L) or decreased by ≥ 2.8 mmol/L from baseline, or 3) a total daily insulin dose that has decreased by ≥ 25% or total daily sulfonylurea dose that has decreased by ≥ 50% and an HbA1c that is unchanged or decreased from baseline.|Before and 0.5, 1, 1.5, and 2 hours after a glucose drink at Week 12 or last observation (Group 1) or Week 16 or last observation (Group 2)|All enrolled participants with IGT / T2DM at Baseline who received at least one dose of study drug and had non-missing post-baseline data collected, with exclusions based on clinical judgment and/or important protocol deviations applied on a visit and outcome level rather than a participant level.|||Percentage of participants||95% Confidence Interval|Number
2551867|NCT02804750|Secondary|Percentage of Participants With IGT / T2DM Who Experienced a ≥25% Reduction in AUCglucose Following Treatment With CORT125134|Improvement in glucose control was defined as a participant who experiences at least a 25% decrease from baseline in area under the concentration-time curve for blood glucose (AUCglucose) who has not taken an additional diabetes medication during the treatment period or increased the dosage of a concurrent diabetes medication.|Before and 0.5, 1, 1.5, and 2 hours after a glucose drink at Week 12 or last observation (Group 1) or Week 16 or last observation (Group 2)|All enrolled participants with IGT / T2DM at Baseline who received at least one dose of study drug and had at least one post-baseline assessment.|||Percentage of participants||95% Confidence Interval|Number
2551868|NCT02804750|Secondary|Percentage of Participants With Hypertension Who Experience Improvement in Blood Pressure Following Treatment With CORT125134|Improvement in blood pressure was defined as a participant who experiences at least a 5 mmHg decrease in mean diastolic or systolic BP from baseline who has not taken an additional antihypertensive medication during the treatment period or increased the dosage of a concurrent antihypertensive medication.|Group 1: Week 12 or last observation; Group 2: Week 16 or last observation|All enrolled participants with hypertension at Baseline who received at least one dose of study drug and had at least one post-baseline assessment.|||Percentage of participants||95% Confidence Interval|Number
2551869|NCT02804750|Primary|Percentage of Participants With One or More Severe (≥Grade 3) Adverse Events|All treatment-emergent adverse events with Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (severe) were recorded and summarized.|Group 1: up to Week 16; Group 2: up to Week 20|All enrolled participants who received at least 1 dose of study drug|||Participants|||Count of Participants
2551870|NCT02804750|Primary|Percentage of Participants With One or More Adverse Events|All treatment-emergent adverse events were recorded and summarized.|Group 1: up to Week 16; Group 2: up to Week 20|All enrolled participants who received at least 1 dose of study drug|||Participants|||Count of Participants
2551871|NCT02804594|Other Pre-specified|Changes in Metabolite Levels in Deep Grey Matter, and Surrounding White Matter on the Magnetic Resonance Images (MRI) From Baseline.|Conventional T2/ T1-weighted images will be obtained at baseline for all subjects enrolled in the treatment phase of the study. We will perform brain MRI on 7T machine, and the sequences will be collected at baseline, and week-4 visit.|4 weeks||2020-05-31|05/2020||||
2551872|NCT02804594|Secondary|Change in Level of Blood Markers From Baseline|Baseline to week 4 change in blood GSH/GSSG ratio (wherein GSH is glutathione in reduced state and GSSG is glutathione in oxidized state) and grey matter GSH concentration on 7T MR spectroscopy (MRS) between groups. We hypothesize that fatigue is associated with the GSH/GSSG ratio.|4 weeks|Study participants enrolled in the treatment period are included in the analysis.|||mean absolute change in GSH/GSSG ratio||Standard Deviation|Mean
2551873|NCT02804594|Secondary|Change in Fatigue Score on Questionnaires From Baseline|Change in fatigue score on questionnaires from baseline visit to week-4 is calculated for the Modified Fatigue Impact Scale (MFIS) questionnaire. The MFIS is a self-report measure to rate fatigue in Multiple Sclerosis. The total score, ranging from 0 to 84 is the sum of three subscales (physical, cognitive, and psychosocial functioning). Higher numbers indicate greater fatigue. Modified fatigue Impact scale of more than 38 is one of the inclusion criteria for the study. Study participants who scored higher value on the questionnaire at week-4 are considered to have worsened fatigue from the baseline visit.|4 weeks|Study participants enrolled in the treatment period are included in the analysis.|||scores on a scale||Standard Deviation|Mean
2551874|NCT02804594|Primary|Number of Adverse Events Reported Since Baseline Visit That Are Related to N-acetyl Cysteine.|Number of adverse events reported since baseline visit that are related to N-acetyl cysteine will be compared to the number of adverse events reported by participants in the placebo group.|4 weeks|Study participants enrolled in the treatment period are included in the analysis.|||adverse events|||Number
2551875|NCT02804399|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (All Causalities and Treatment-Related)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a casual relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: 1) resulted in death; 2) was life threatening (immediate risk of death); 3) required inpatient hospitalization or prolongation of existing hospitalization; 4) resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); 5) resulted in congenital anomaly/birth defect. TEAE included both non-serious adverse events and serious adverse events.|Baseline to about 18 days after the first PF-06463922 dose.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained.|||Participants|||Count of Participants
2551876|NCT02804399|Other Pre-specified|Number of Participants With Concomitant Treatments Meeting the Criteria of Potentially Significant Clinical Concerns|Participants abstained from all concomitant treatments, except for the treatment of adverse events. Limited use of non-prescription medications that were not believed to affect participant safety or the overall results of the study might be permitted on a case by case basis following approval by the sponsor. All participants were questioned about concomitant treatment at each clinic visit. Treatments taken within 28 days before the first dose of study investigational product were documented as a prior treatment. Treatment taken after the first dose of study investigational product were documented as concomitant treatments. Females taking hormone replacement therapy might be eligible to participate in this study if they were willing to discontinue therapy at least 28 days prior to the first dose of study treatment and remained off hormonal therapy for duration of the study. Clinical significance was judged by the investigator.|Baseline to about 18 days after the first PF-06463922 dose.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained.|||Participants|||Count of Participants
2551877|NCT02804399|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Findings Meeting the Criteria of Potentially Significant Clinical Concerns|PR interval was the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization. Criteria for potentially clinically important changes (chg) in ECG were defined as: absolute values of PR interval >=200 to <220 msec, >=220 to <240 msec, >=240 to <260 msec and >=260 msec. Increase from baseline >=40, <60, >=60 and <80, >=80, and relative change from baseline >25%. The beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formular (QTCF) of 450 to <480 msec, 480 to <500 msec and >=500 msec, or an increase of 30 to <60 msec of >=60 msec. Maximum is abbreviated as Max.|Baseline to about 18 days after the first PF-06463922 dose.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained.|||Participants|||Count of Participants
2551878|NCT02804399|Other Pre-specified|Number of Participants With Changes From Baseline and Absolute Values in Vital Signs Meeting the Criteria of Potentially Significant Clinical Concerns|"Criteria for potentially clinically important changes in vital signs were defined as: supine and standing systolic blood pressure (SBP) of less than (<90) millimeters of mercury (mm Hg) or change in supine and standing SBP more than or equal to (>=) 30 mm Hg; supine and standing diastolic blood pressure (DBP) of < 50 mm Hg or change in supine and standing DBP of >= 20 mm Hg; supine and standing pulse rate of < 40 or >120 beats per minute (bpm). Figure 99999 signifies data not measurable/applicable. Maximum Decrease is abbreviated as Max.Dec., and Maximum Increase is abbreviated as Max.Inc. n is the number of participants contributing to the parameter, not applicable is abbreviated as N/A."|Baseline to about 18 days after the first PF-06463922 dose.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained.|||Participants|||Count of Participants
2551879|NCT02804399|Other Pre-specified|Number of Participants With Physical Examination Findings Meeting the Criteria of Potentially Significant Clinical Concern|A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The limited or abbreviated physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Clinical significance was judged by the investigator.|Baseline to about 18 days after the first PF-06463922 dose.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained.|||Participants|||Count of Participants
2551880|NCT02804399|Other Pre-specified|Number of Participants With End of Study Abnormal Laboratory Findings Meeting the Criteria of Potentially Significant Clinical Concern|The total number of participants with laboratory test abnormalities was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis and some other tests (including follicle-simulating hormone[FSH], urine drug screening, hepatitis B surface antigen [HBsAg], hepatitis B core antibody [HBcAb], hepatitis C virus antibody [HCVAb] and human immunodeficiency virus [HIV]. Clinical significance was judged by the investigator.|Baseline to about 18 days after the first PF-06463922 dose|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained.|||Participants|||Count of Participants
2551888|NCT02804399|Secondary|Plasma AUClast for PF-06895751 When PF-06463922 Given Alone and With Rifampin|AUClast was the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period. PF-06895751 was the metabolite of PF-06463922.|Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2551881|NCT02804399|Secondary|Plasma Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for AUCinf (MRAUCinf) of PF-06463922 and Its Metabolite: When PF-06463922 Given Alone and With Rifampin|AUCinf was the plasma area under the plasma concentration-time profile from time 0 extrapolated to infinite time of PF-06463922 and PF-06895751 ( metabolite of PF-06463922). The molecular weight adjusted metabolite/parent ratio (PF-06895751/PF-06463922) for AUCinf was presented. The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.|Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained. Here, “Number of Participants analyzed” signifies number of participants evaluable for this outcome measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2551882|NCT02804399|Secondary|Plasma Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for AUClast (MRAUClast) of PF-06463922 and Its Metabolite: When PF-06463922 Given Alone and With Rifampin|AUClast was the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration of PF-06463922 and PF-06895751 ( metabolite of PF-06463922). The molecular weight adjusted metabolite/parent ratio (PF-06895751/PF-06463922) for AUClast was presented. The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period. PF-06895751 was the metabolite of PF-06463922.|Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2551883|NCT02804399|Secondary|Plasma Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for Cmax (MRCmax) of PF-06463922 and Its Metabolite: When PF-06463922 Given Alone and With Rifampin|Cmax was the maximum observed plasma concentration of PF-06463922 and PF-06895751 ( metabolite of PF-06463922). The molecular weight adjusted metabolite/parent ratio (PF-06895751/PF-06463922) for Cmax was presented. The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.|Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2551884|NCT02804399|Secondary|Plasma Cmax for PF-06895751 When PF-06463922 Given Alone and With Rifampin|Cmax was the maximum observed plasma concentration. The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period. PF-06895751 was the metabolite of PF-06463922.|Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2551885|NCT02804399|Secondary|Plasma t1/2 for PF-06895751 When PF-06463922 Given Alone and With Rifampin|T1/2 was the terminal plasma half-life. The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period. PF-06895751 was the metabolite of PF-06463922.|Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained. Here, “Number of Participants analyzed” signifies number of participants evaluable for this outcome measure.|||hr||Standard Deviation|Mean
2551886|NCT02804399|Secondary|Plasma Tmax for PF-06895751 When PF-06463922 Given Alone and With Rifampin.|Tmax was the time for maximum observed plasma concentration (Cmax). The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period. PF-06895751 was the metabolite of PF-06463922.|Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained.|||hr||Full Range|Median
2551887|NCT02804399|Secondary|Plasma AUCinf for PF-06895751 When PF-06463922 Given Alone and With Rifampin|AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period. PF-06895751 was the metabolite of PF-06463922.|Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained. Here, “Number of Participants analyzed” signifies number of participants evaluable for this outcome measure.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2552655|NCT02791763|Secondary|Number of PD Participants Who Had an Hgb Level of Less Than 7.5 g/dL|Number of PD participants who had an Hgb level of less than 7.5 g/dL is presented.|Up to week 52|Efficacy PD Population|||Participants|||Count of Participants
2551889|NCT02804399|Secondary|Plasma Vz/F for PF-06463922 Given Alone and With Rifampin|Vz/F is the apparent volume of distribution (only after single dose).The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.|Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg administration with rifampin in Period 2.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained. Here, “Number of Participants analyzed” signifies number of participants evaluable for this outcome measure.|||liter||Geometric Coefficient of Variation|Geometric Mean
2551890|NCT02804399|Secondary|Plasma CL/F for PF-06463922 Given Alone and With Rifampin|CL/F is the apparent oral clearance. The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.|Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained. Here, “Number of Participants analyzed” signifies number of participants evaluable for this outcome measure.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2551891|NCT02804399|Secondary|Plasma t1/2 for PF-06463922 Given Alone and With Rifampin|Terminal plasma half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half. The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.|Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained. Here, “Number of Participants analyzed” signifies number of participants evaluable for this outcome measure.|||hr||Standard Deviation|Mean
2551892|NCT02804399|Secondary|Plasma Tmax for PF-06463922 Given Alone and With Rifampin|Tmax is the time for maximum observed plasma concentration (Cmax). The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.|Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained.|||hr||Full Range|Median
2551893|NCT02804399|Secondary|Plasma AUClast for PF-06463922 Given Alone and With Rifampin|AUClast is the plasma area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration. The PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.|Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2551894|NCT02804399|Primary|Plasma Cmax for PF-06463922 Given Alone and With Rifampin|Cmax is the maximum observed plasma concentration. PK parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.|Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2551895|NCT02804399|Primary|Plasma AUCinf for PF-06463922 Given Alone and With Rifampin|AUCinf is the plasma area under the plasma concentration-time profile from time 0 extrapolated to infinite time. The pharmacokinetics (PK) parameter analysis population was defined as all participants enrolled and treated who have at least 1 of the PF-06463922 PK parameters of primary interest in at least 1 treatment period.|Predose, 0.5, 1, 1.5, 2, 4, 6, 12, 24, 36, 48, 60, 72, 96, 120 hours postdose on Day 1 after PF-06463922 100 mg administration in Period 1, and at the same time points on Day 8 after PF-06463922 100 mg with rifampin administration in Period 2.|All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained. Here, “Number of Participants analyzed” signifies number of participants evaluable for this outcome measure.|||nanogram (ng)*hr/ millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
2551896|NCT02803749|Secondary|Mean Change in Hospital Anxiety and Depression Scale (HADS) - Depression From Baseline to 12 Weeks|The HADS assesses anxiety on a scale of 0-21 and depression on a scale of 0-21 with higher scores indicating higher levels of anxiety and depression respectively.|12 weeks||||units on a scale||Standard Error|Mean
2551897|NCT02803749|Secondary|"Number of Much Improved or Very Much Improved on Clinical Global Impressions-Improvement (CGI-I) at 12 Weeks"|"The CGI-I assesses clinician global impression of improvement on a 7-point scale where 1 = very much improved and 7 = very much worse."|12 weeks||||Participants|||Count of Participants
2551898|NCT02803749|Secondary|Mean Change in Unified Dyskinesia Rating Scale (UDysRS) From Baseline to 12 Weeks|The UDysRS assesses dyskinesias on a scale of 0-104 where a higher score represents more severe dyskinesias.|12 weeks||||score on a scale||Standard Error|Mean
2552656|NCT02791763|Secondary|Percentage of ND Participants Who Had an Hgb Level of Less Than 7.5 g/dL|Percentage of ND participants who had an Hgb level of less than 7.5 g/dL is presented.|Up to week 52|ITT Population|||Percentage of participants|||Number
2551899|NCT02803749|Secondary|Mean Change in Anxiety Using the Hospital Anxiety and Depression Scale (HADS)|The HADS assesses anxiety on a scale of 0-21 and depression on a scale of 0-21 with higher scores indicating higher levels of anxiety and depression respectively.|baseline to 12 weeks||||score on a scale||Standard Error|Mean
2551900|NCT02803749|Secondary|"Number of Much Improved or Very Much Improved on Patient Global Impressions-Improvement (PGI-I) at 12 Weeks"|"The PGI-I assesses patient global impression of improvement on a 7-point scale where 1 = very much improved and 7 = very much worse."|12 weeks||||Participants|||Count of Participants
2551901|NCT02803749|Secondary|Number of Responders (>50% Reduction From Baseline or Reduction to ≤7 on HAM-A) at 12 Weeks|The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety.|12 weeks||||Participants|||Count of Participants
2551902|NCT02803749|Secondary|Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 12 Weeks|The HAM-A assess anxiety on 0-56 scale where a higher score represents a higher level of anxiety.|12 weeks||||score on a scale||Standard Error|Mean
2551903|NCT02803749|Primary|The Number of Participants Who Fail to Complete the 12-week Study on Study Drug.||12 weeks||||Participants|||Count of Participants
2551904|NCT02803580|Secondary|Health Care Resource Consumption From Diagnosis up to End of 12 Months Follow-up According to the Italian National Health Service (INHS)|"The health care sector-related costs at diagnosis and from diagnosis up to the end of 12-month follow-up according to the INHS point of view, was carried out in a two-step approach:~(i)First of all the resource consumption exclusively related to both IPF, IPF exacerbations and IPF-related adverse events since diagnosis was collected or estimated and then (ii) A monetary value was assigned to the collected or estimated resource consumption.~Health care resource consumption was computed during observational period in terms of number of (inward and day-hospital) hospitalizations and number of Intensive Care Unit (ICU) admissions."|Up to 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||Days||Standard Deviation|Mean
2551905|NCT02803580|Secondary|HRQoL Measured With EQ VAS|"The quality of life was evaluated by the EQ-5D-5L a standardized measure of health status developed by EuroQol Group to provide a simple generic measure of health status for clinical and economic evaluation. EQ-5D-5L consists of 2 sections: EQ-5D descriptive system and EQ VAS. The EQ VAS indicate the health status self-assessed by the participants on a visual analogue scale from 0 to 100, where 100 is the best imaginable health state and 0 the worst imaginable health state. It can be used as a quantitative measure of health as judged by participants."|Baseline, 6 months and 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||Unit on scale||Standard Deviation|Mean
2551906|NCT02803580|Secondary|HRQoL Variation Measured With EuroQol Descriptive System|"The quality of life was evaluated by the EuroQol 5-dimension 5-level (EQ-5D-5L) a standardized measure of health status developed by EuroQol Group to provide a simple generic measure of health status for clinical and economic evaluation. EQ-5D-5L was filled in by participants, it was easy from a cognitive point of view, since it took only few minutes for filling. EQ-5D-5L consists of 2 sections: EQ-5D descriptive system and EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression."|Baseline, 6 months and 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||Percentage (%) of participants|||Number
2551907|NCT02803580|Secondary|Health Related Quality of Life Variation Measured With Saint George's Respiratory Questionnaire|Health Related Quality of Life (HRQoL) variation measured with Saint George's Respiratory Questionnaire (SGRQ), developed to measure health in chronic airflow limitation. It is a disease-specific instrument designed to measure health impairment in terms of impact on overall health, daily life, and perceived well-being in participants with obstructive airways disease. Three component scores (symptoms, activity and impacts on daily life) and a total score were calculated, with lower scores corresponding to better health. The Total score is calculated by summing all positive responses in the questionnaire and expressing the result as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.|Baseline, 6 months and 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||Unit on scale||Inter-Quartile Range|Median
2551908|NCT02803580|Secondary|Number of Exacerbations During 12 Months of Observation|Number of participants with mild, moderate and severe exacerbations during the observation period are presented. An exacerbation was considered occurred during observation period if onset date ≥ date of first IPF diagnosis and onset date ≤ last available visit date (for participants who completed the study) or date of drop out or date of death (for participants who did not complete the study).|Up to 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.|||Participants|||Number
2551909|NCT02803580|Secondary|IPF Treatment Modalities: Prescribed Drugs and Dose|IPF Patients with ≥1 pharmacological therapy for IPF ongoing at baseline, 3-month, 6-month and 12-month follow up visits are presented. The pharmacological therapies used for IPF treatment are Nintedanib and Pirfenidone.|Baseline, 3 months, 6 months and 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||Participants|||Number
2551910|NCT02803580|Secondary|IPF Treatment Modalities: Lung Transplantation|Number of participants who had lung transplantation at baseline, 3-month, 6-month and 12-month follow up visits are presented.|Baseline, 3 months, 6 months and 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||Participants|||Number
2552531|NCT02793154|Primary|Part A: Total Protein, Albumin Levels at Indicated Time Points|Blood samples were collected for analysis of clinical chemistry parameters including total protein and albumin levels. Individual Par. data at indicated time point has been presented.|Day 5|All Subjects Population|||Grams per liter|||Number
2551911|NCT02803580|Secondary|IPF Treatment Modalities: Non-pharmacological Treatment|Number of participants with ≥1 non-pharmacological therapy for IPF ongoing at baseline (visit 1), 3-month (visit 2), 6-month (visit 3) and 12-month (visit 5) follow up visits are presented.|Baseline, 3 months, 6 months and 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||Participants|||Number
2551912|NCT02803580|Secondary|Number of Participants With Different Methods Used for IPF Diagnosis|Several diagnostic approaches were used to detect IPF, the main ones being High Resolution chest Computer Tomography (HRCT), surgical lung biopsy, Bronchoalveolar lavage (BAL), transbronchial biopsy and spirometry.|Baseline|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.|||Participants|||Number
2551913|NCT02803580|Secondary|IPF Disease Severity and Manifestation|IPF disease severity and manifestation (including lung function, cardiopulmonary exercise testing and/or exercise capacity if available, laboratory values) is measured by the FVC. Percentages are calculated out of the total number of evaluable participants with available FVC of the predicted at baseline.|Baseline|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.|||Percentage of participants|||Number
2551914|NCT02803580|Secondary|Number of Participants With Comorbidity|Number of participants with ongoing comorbidities (such as gastroesophageal reflux disease, pulmonary hypertension, emphysema, lung cancer, coronary heart disease, depression) are provided. Some participants reported more than one comorbidity at enrollment.|Baseline|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.|||Participants|||Number
2551915|NCT02803580|Secondary|IPF Risk Factors: Family History|IPF enrolled participants were described in terms of potential IPF risk factors; number of participants as per their family history for IPF are presented.|Baseline|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.|||Participants|||Number
2551916|NCT02803580|Secondary|IPF Risk Factors: Exposure to Drugs Associated With IPF|IPF enrolled participants were described in terms of potential IPF risk factors; number of participants as per their exposure to drugs associated with IPF are presented.|Baseline|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.|||Participants|||Number
2551917|NCT02803580|Secondary|IPF Risk Factors: Environmental Exposure|IPF enrolled participants were described in terms of potential IPF risk factors; number of participants as per their environmental exposure (such as bricklayer, building material dust, cement dust, chemical gas, coal dust, factory food, marble dust, masonry dust, mold, paint, powdered detergent and textile material) are presented.|Baseline|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.|||Participants|||Number
2551918|NCT02803580|Secondary|IPF Risk Factors: Smoking Habit|IPF enrolled participants were described in terms of potential IPF risk factors; number of participants as per their smoking habits are presented.|Baseline|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.|||Participants|||Number
2551919|NCT02803580|Secondary|Characteristic of Participants at Enrollment: Key Demographic Data: Marital Status|IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their marital status are presented.|Baseline|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.|||Participants|||Number
2551920|NCT02803580|Secondary|Characteristic of Participants at Enrollment: Key Demographic Data: Housing Situation|IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their housing situation are presented.|Baseline|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.|||Participants|||Number
2551921|NCT02803580|Secondary|Characteristic of IPF Patients at Enrollment: Key Demographic Data: Body Mass Index|IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their Body mass index are presented.|Baseline|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.|||Participants|||Number
2551922|NCT02803580|Secondary|Characteristic of Participants at Enrollment: Key Demographic Data: Employment Status|IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their employment status are presented.|Baseline|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.|||Participants|||Number
2551923|NCT02803580|Secondary|Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level|IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their highest education level.|Baseline|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.|||Participants|||Number
2551924|NCT02803580|Secondary|Characteristic of Participants at Enrollment: Key Demographic Data: Race|IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their race are presented. The data is provided in baseline section.|Baseline|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.|||Participants|||Number
2551925|NCT02803580|Secondary|Characteristic of Participants at Enrollment: Key Demographic Data: Gender|IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their gender are presented. The data is provided in baseline section.|Baseline|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.|||Participants|||Number
2551926|NCT02803580|Secondary|Characteristic of Participants at Enrollment: Key Socio-demographic Data: Age|IPF enrolled participants were described in terms of socio-demographic variables (e.g. age, gender, race, body mass index, educational degree, and employment status) at baseline.|Baseline|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.|||Years||Standard Deviation|Mean
2552657|NCT02791763|Secondary|Number of ND Participants Who Had an Hgb Level of Less Than 7.5 g/dL|Number of ND participants who had an Hgb level of less than 7.5 g/dL is presented.|Up to week 52|ITT Population|||Participants|||Count of Participants
2551927|NCT02803580|Primary|Change From Baseline to Follow-up Visits in Exercise Tolerance|"Change from baseline to follow-up visits in exercise tolerance was evaluated by means of change in 6 minute walked distance test.~Change versus baseline was calculated as parameter at follow up - parameter at baseline.~A positive value of change indicates a better outcome. The 6-minute walked distance test was carried out using two parameters start of peripheral capillary oxygen saturation (SpO2) and SpO2 at the end of the test. Only participants with values available at baseline and at follow up were considered"|Baseline, 3 months, 6 months, 9 months and 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||Percentage (%) of SpO2||Standard Deviation|Mean
2551928|NCT02803580|Primary|Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide in Arterial Blood at Rest|"In calculating the change from baseline to follow-up visits in lung function: Partial Pressure of Carbon dioxide in arterial blood at rest (PaCO2), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:~Change in parameter PaCO2 = value of parameter PaCO2 at follow up visit - value of parameter PaCO2 at baseline visit.~A positive value of change indicates a better outcome."|Baseline, 3 months, 6 months, 9 months and 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||mmHg||Standard Deviation|Mean
2551929|NCT02803580|Primary|Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen in Arterial Blood at Rest|"In calculating the change from baseline to follow-up visits in lung function: Partial Pressure of Oxygen in arterial blood at rest (PaO2), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:~Change in parameter PaO2 = value of parameter PaO2 at follow up visit - value of parameter PaO2 at baseline visit.~A positive value of change indicates a better outcome."|Baseline, 3 months, 6 months, 9 months and 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||mmHg||Standard Deviation|Mean
2551930|NCT02803580|Primary|Change From Baseline to Follow-up Visits in Lung Function: Oxygen Saturation|"In calculating the change from baseline to follow-up visits in lung function: Oxygen Saturation (SaO2), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:~Change in parameter SaO2 = value of parameter SaO2 at follow up visit - value of parameter SaO2 at baseline visit.~A positive value of change indicates a better outcome."|Baseline, 3 months, 6 months, 9 months and 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||Percentage (%) of SaO2||Standard Deviation|Mean
2551931|NCT02803580|Primary|Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide|"In calculating the change from baseline to follow-up visits in lung function: Partial Pressure of Carbon dioxide (PCO2), only patients with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:~Change in parameter PCO2 = value of parameter PCO2 at follow up visit - value of parameter PCO2 at baseline visit.~A positive value of change indicates a better outcome."|Baseline, 3 months, 6 months, 9 months and 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||mmHg||Standard Deviation|Mean
2551932|NCT02803580|Primary|Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen|"In calculating the change from baseline to follow-up visits in lung function: Partial Pressure of Oxygen (PO2), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:~Change in parameter PO2 = value of parameter PO2 at follow up visit - value of parameter PO2 at baseline visit.~A positive value of change indicates a better outcome."|Baseline, 3 months, 6 months, 9 months and 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||Millimeter mercury (mmHg)||Standard Deviation|Mean
2551933|NCT02803580|Primary|Change From Baseline to Follow-up Visits in Lung Function: Diffusion Capacity for Carbon Monoxide|"In calculating the change from baseline to follow-up visits in lung function: Diffusion capacity for carbon monoxide (DLCO), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:~Change in parameter DLCO = value of parameter DLCO at follow up visit - value of parameter DLCO at baseline visit.~A positive value of change indicates a better outcome.~Values of DLCO with unit = milliliter/minute/millimeter mercury (ml/min/mmHg) were converted to micromole/minute/kilopascal (mmol/min/kPa) according to the following formula:~DLCO (mmol/min/kPa) = DLCO (ml/min/mmHg)/2.986 [46]."|Baseline, 3 months, 6 months, 9 months and 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||mmol/min/kPa||Standard Deviation|Mean
2551934|NCT02803580|Primary|Change From Baseline to Follow-up Visits in Lung Function: Total Lung Capacity|"In calculating the change from baseline to follow-up visits in lung function: Total Lung Capacity (TLC), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:~Change in parameter TLC = value of parameter TLC at follow up visit - value of parameter TLC at baseline visit.~A positive value of change indicates a better outcome."|Baseline, 3 months, 6 months, 9 months and 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||L||Standard Deviation|Mean
2552909|NCT02785900|Secondary|Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate|Number of patients who achieve both remission (CR or CRi) and MRD-negative status|Up to 1.5 years|Intent-to-treat analysis set|||participants||95% Confidence Interval|Number
2551935|NCT02803580|Primary|Change From Baseline to Follow-up Visits in Lung Function: Forced Expiratory Volume in the 1st Second|"In calculating the change from baseline to follow-up visits in lung function: Forced Expiratory Volume in the 1st second (FEV1), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:~Change in parameter FEV1 = value of parameter FEV1 at follow up visit - value of parameter FEV1 at baseline visit.~A positive value of change indicates a better outcome."|Baseline, 3 months, 6 months, 9 months and 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||L||Standard Deviation|Mean
2551936|NCT02803580|Primary|Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Predicted)|"In calculating the change from baseline to follow-up visits in lung function: Forced Vital Capacity (FVC), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:~Change in parameter FVC = value of parameter FVC at follow up visit - value of parameter FVC at baseline visit.~A positive value of change indicates a better outcome.~The value of FVC % of predicted is a relevant parameter to understand and classify the severity of the disease at the diagnosis and to follow up patients during the treatment (i.e. annual rate decline of FVC >10% is a predictor of high rate of mortality)."|Baseline, 3 months, 6 months, 9 months and 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||Percent Predicted||Standard Deviation|Mean
2551937|NCT02803580|Primary|Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Actual)|"In calculating the change from baseline to follow-up visits in lung function: Forced Vital Capacity (FVC), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:~Change in parameter FVC = value of parameter FVC at follow up visit - value of parameter FVC at baseline visit.~A positive value of change indicates a better outcome."|Baseline, 3 months, 6 months, 9 months and 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||L||Standard Deviation|Mean
2551938|NCT02803580|Primary|Change From Baseline to Follow-up Visits in Lung Function: Vital Capacity|"In calculating the change from baseline to all follow-up visits (3 months, 6 months, 9 months and 12 months) in lung function: Vital Capacity (VC), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as:~Change in parameter VC = value of parameter VC at follow up visit - value of parameter VC at baseline visit.~A positive value of change indicates a better outcome."|Baseline, 3 months, 6 months, 9 months and 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||Liters (L)||Standard Deviation|Mean
2551939|NCT02803580|Primary|Percentage of Participants With IPF Symptoms|"Percentage of participants with IPF symptoms such as cough, fatigue, dizziness, chest pain or any other symptom at 12-month follow up visit. The symptoms in the class 'other' reported upon specific visits were dyspnea, hemoptysis, post-nasal drip, sputum, weight loss, worsening of fatigue and lack of appetite.~Baseline (V1), 3 months (V2), 6 months (V3), 9 months (V4) and 12 months (V5)."|Baseline, 3 months, 6 months, 9 months and 12 months|All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered.|||Percentage of participants|||Number
2551940|NCT02803138|Secondary|Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria|The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented.|12 weeks after the last actual dose of study drug|Core population (CP): all participants of the target population (all participants in the safety population who met all inclusion criteria) who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants|||Number
2551941|NCT02803138|Secondary|Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria|Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure.|12 weeks after the last actual dose of study drug|Core population (CP): all participants of the target population (all participants in the safety population who met all inclusion criteria) who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants|||Number
2551942|NCT02803138|Secondary|Percentage of Participants Meeting Relapse Criteria|Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment.|12 weeks after the last actual dose of study drug|Core population (CP): all participants of the target population (all participants in the safety population who met all inclusion criteria) who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants|||Number
2551943|NCT02803138|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL).|12 weeks after the last actual dose of study drug|Core population (CP): all participants of the target population (all participants in the safety population who met all inclusion criteria) who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants|||Number
2551944|NCT02803138|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment.|Up to 24 weeks|Core population (those meeting inclusion criteria and treated according to the standard of care and w/in local label guidelines for specific disease characteristics [cirrhotic status, genotype]) who had at least 1 undetectable or unquantifiable, on-treatment HCV RNA measurement and at least 1 on-treatment or end of treatment measurement thereafter|||percentage of participants||95% Confidence Interval|Number
2551945|NCT02803138|Secondary|Percentage of Participants With Relapse|Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL.|Up to 48 weeks after the last actual dose of study drug|Core population (CP): all participants of the target population (all participants in the safety population who met all inclusion criteria) who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants||95% Confidence Interval|Number
2551946|NCT02803138|Secondary|Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Posttreatment|"Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.~The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all participants who fulfilled one of the following criteria:~evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN~an HCV RNA value ≥50 IU/mL at the last measurement post-baseline~HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure"|12 weeks (at least 70 days) after the last actual dose of study drug|Core population with sufficient follow-up data regarding SVR12|||percentage of participants||95% Confidence Interval|Number
2551947|NCT02803138|Secondary|Percentage of Participants With Virologic Response at End of Treatment (EoT)|Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment.|Up to 24 weeks|Core population (CP): all participants of the target population (all participants in the safety population who met all inclusion criteria) who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants||95% Confidence Interval|Number
2551948|NCT02803138|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug.|12 weeks after the last actual dose of study drug|Core population (CP): all participants of the target population (all participants in the safety population who met all inclusion criteria) who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants||95% Confidence Interval|Number
2551949|NCT02802878|Secondary|Change in 5-chair Stand Time|The chair stand test is a validated measure of physical performance in adults with knee osteoarthritis. Participants were instructed to stand from a chair (seat height 44.45 cm) 5 times as quickly as they could without using their arms. Two trials were timed and averaged.|Baseline and 12-week follow-up|4 participants in the hybrid training group discontinued the intervention due to unrelated pain, knee injections, car issues, and unrelated hospitalization. 3 participants in the low intensity exercise group discontinued the intervention due to unrelated pain, fatigue and the inability to gain strength due to radiation overdose (unrelated).|||seconds||Standard Deviation|Mean
2551950|NCT02802878|Secondary|Change in 20-meter Walk Time|A timed 20-meter walk was completed as a measure of lower limb physical performance. Participants were instructed to walk along a 20-meters straight, uninterrupted course as quickly as they could. Timing started when the participant initiated foot movement and stopped when both feet crossed the 20-meter mark. Times for two trials were recorded and the averaged.|Baseline and 12-week follow-up|4 participants in the hybrid training group discontinued the intervention due to unrelated pain, knee injections, car issues, and unrelated hospitalization. 3 participants in the low intensity exercise group discontinued the intervention due to unrelated pain, fatigue and the inability to gain strength due to radiation overdose (unrelated).|||seconds||Standard Deviation|Mean
2551951|NCT02802878|Secondary|Change in Knee Pain Assessed by a Knee Injury and Osteoarthritis Outcome Score|The Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale was used at baseline and follow-up to assess participant outcomes. The pain subscale is made up of 9 questions and was scored from zero to 100, with zero corresponding to extreme knee problems and 100 corresponding to no knee problems.|Baseline and 12-week follow-up|4 participants in the hybrid training group discontinued the intervention due to unrelated pain, knee injections, car issues, and unrelated hospitalization. 3 participants in the low intensity exercise group discontinued the intervention due to unrelated pain, fatigue and the inability to gain strength due to radiation overdose (unrelated).|||units on a scale||Standard Deviation|Mean
2551952|NCT02802878|Secondary|Change in Maximal Isokinetic Knee Flexor Torque by Body Mass Assessed by Isokinetic Dynamometer.|Participants will be familiarized with strength testing equipment and counseled on proper lifting technique. They will undergo testing to determine their peak isokinetic knee flexor torque, using an isokinetic dynamometer.|Baseline and 12-week follow-up|4 participants in the hybrid training group discontinued the intervention due to unrelated pain, knee injections, car issues, and unrelated hospitalization. 3 participants in the low intensity exercise group discontinued the intervention due to unrelated pain, fatigue and the inability to gain strength due to radiation overdose (unrelated).|||Newton-meters/kilogram||Standard Error|Least Squares Mean
2551976|NCT02802345|Secondary|Change From Baseline in Dyspnoea Using the University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) at Week 12|The UCSD SOBQ is a 24-item questionnaire developed to measure breathlessness on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. The mean and standard error presented for descriptive statistics are actually adjusted mean for change from baseline and its standard error.|Baseline and week 12|Treated Set (TS): TS included all patients who were randomised to a treatment group and received at least one dose of randomised study medication.|||Unit on scale||Standard Deviation|Mean
2551953|NCT02802878|Primary|Change in Maximal Isokinetic Knee Extensor Torque by Body Mass Assessed by Isokinetic Dynamometer.|Participants will be familiarized with strength testing equipment and counseled on proper lifting technique. They will undergo testing to determine their peak isokinetic knee extensor torque at 60°/sec, using an isokinetic dynamometer. These testing procedures will then be repeated for the other side.|Baseline and 12-week follow-up|4 participants in the hybrid training group discontinued the intervention due to unrelated pain, knee injections, car issues, and unrelated hospitalization. 3 participants in the low intensity exercise group discontinued the intervention due to unrelated pain, fatigue and the inability to gain strength due to radiation overdose (unrelated).|||Newton-meters/kilogram||Standard Error|Least Squares Mean
2551954|NCT02802865|Secondary|Pregnancy Loss|Pregnancy Loss: any pregnancy loss including biochemical pregnancy, ectopic pregnancy, and miscarriage; No Pregnancy Loss: no pregnancy loss including biochemical pregnancy, ectopic pregnancy, or miscarriage.|9-10 months after treatment|Participants who conceived|||Participants|||Count of Participants
2551955|NCT02802865|Secondary|Live Birth|Live Birth: delivery of a live infant; No Live Birth: no delivery of a live infant|9-10 months after treatment||||Participants|||Count of Participants
2551956|NCT02802865|Secondary|Multiple Gestation|Multiple Gestation: an intrauterine pregnancy with multiple fetal heart rates determined by ultrasonography; No Multiple Gestation: either no intrauterine pregnancy, or an intrauterine pregnancy with a single fetal heart rate determined by ultrasonography|9-10 months after treatment||||Participants|||Count of Participants
2551957|NCT02802865|Secondary|Clinical Pregnancy|Clinical Pregnancy: an intrauterine pregnancy with fetal heart motion determined by ultrasonography; No Clinical Pregnancy: no intrauterine pregnancy with fetal heart motion determined by ultrasonography|6-7 weeks after treatment||||Participants|||Count of Participants
2551958|NCT02802865|Secondary|Conception|Conception: a positive serum or urinary test of hCG; No conception: Neither a positive serum or urinary test of hCG|5 weeks after treatment||||Participants|||Count of Participants
2551959|NCT02802865|Secondary|Endometrial Thickness|Thickness of endometrial lining assessed by ultrasound|Cycle day 12-14||||mm||Standard Deviation|Mean
2551960|NCT02802865|Secondary|Size of Largest Developing Follicle|Size of largest follicle on ultrasound|Cycle day 12-14||||mm||Inter-Quartile Range|Median
2551961|NCT02802865|Secondary|Number of Developing Follicles|Number of follicles measuring > 10mm on ultrasound|Cycle day 12-14||||follicles||Inter-Quartile Range|Median
2551962|NCT02802865|Primary|Number of Participants Achieving Ovulation Measured by Mid-luteal Progesterone Level|Ovulation: mid-luteal progesterone > /=3 ng/mL. No ovulation: mid-luteal progesterone <3ng/mL.|7 days following LH surge or at cycle day 21 if no LH surge was detected||||Participants|||Count of Participants
2551963|NCT02802592|Secondary|Change in Quality of Life as Assessed by Short Form-36 Quality of Life Survey||assessed at 1-week, 1-month, and 3-months from date of surgery|This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure.||||||
2551964|NCT02802592|Secondary|Overall Hospitalization Cost||up to one year from date of surgery|This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure.||||||
2551965|NCT02802592|Secondary|Length of Stay (# of Total Days Hospitalized)||up to one year from date of surgery|This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure.||||||
2551966|NCT02802592|Primary|Total Number of Packed Red Blood Cells Transfused During the Intraoperative and Immediate Postoperative Period||Start of surgery to 96 hours post op|This study was terminated prematurely due to a loss of funding. There is no data available for this outcome measure.||||||
2551967|NCT02802449|Secondary|Oxidative Stress Markers: Isoprostane||Baseline and Week 6||||pg/ml||Standard Deviation|Mean
2551968|NCT02802449|Secondary|Oxidative Stress Markers: GSH||Baseline and Week 6||||umol/L||Standard Deviation|Mean
2551969|NCT02802449|Secondary|Oxidative Stress Markers: Homocysteine||Baseline and Week 6||||umol/L||Standard Deviation|Mean
2551970|NCT02802449|Secondary|Oxidative Stress Markers: Cysteine||Baseline and Week 6||||umol/L||Standard Deviation|Mean
2551971|NCT02802449|Primary|Vitamin D3 Level||Baseline and Week 6||||ng/ml||Standard Deviation|Mean
2551972|NCT02802449|Primary|Plasma PTH Level|Building upon our hypothesis above, this aim exploits the fact that the nuclear Vit-D Receptor (VDR) regulates parathyroid hormone (PTH) gene transcription. Therefore the plasma PTH level serves as a sensitive biomarker of the Vit-D nutri-genomic response. This aim will define the multivariate determinants (covariates such as age, BMI, baseline Vit-D level and dietary calcium) of the Vit-D-PTH level relationship (the primary outcome variable) in African-Americans. It is anticipated that the Vit-D supplementation trial will document a wide variance of Vit-D-PTH level relationships that will identify patients at the upper and lower quartiles of the distribution that are either 'nutrient-responsive' or 'nutrient-resistant'. These studies should help identify the 'clinical' characteristics of the sub-set of African-Americans that exhibit the poorest response to Vit-D supplementation.|Baseline and Week 6||||pg/ml||Standard Deviation|Mean
2551973|NCT02802345|Secondary|Percentage of Patients With On-treatment Serious Adverse Events (SAE) From Baseline to Week 24|Percentage of patients with on-treatment serious adverse events (SAE) from baseline to Week 24 is presented.|Baseline and week 24|TS|||Percentage of participants (%)|||Number
2551974|NCT02802345|Secondary|Change From Baseline in Dyspnoea Using UCSD SOBQ at Week 24|The UCSD SOBQ is a 24-item questionnaire developed to to measure breathlessness on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. The mean and standard error presented for descriptive statistics are actually adjusted mean for change from baseline and its standard error.|Baseline and week 24|TS|||Unit on scale||Standard Deviation|Mean
2551975|NCT02802345|Secondary|Change From Baseline in SGRQ Total Score at Week 24|The SGRQ is a 50-item questionnaire developed to measure health status (quality of life). Scores are calculated for three domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. The mean and standard error presented for descriptive statistics are actually adjusted mean for change from baseline and its standard error.|Baseline and week 24|TS|||Unit on scale||Standard Deviation|Mean
2551977|NCT02802345|Primary|Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score at Week 12|The SGRQ is a 50-item questionnaire developed to measure health status (quality of life). Scores are calculated for three domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. Scores range from 0 to 100, with higher scores indicating more limitations. The mean and standard error presented are actually adjusted mean for change from baseline and its standard error.|Baseline and week 12|TS|||Unit on scale||Standard Error|Mean
2551978|NCT02802319|Secondary|% Residual Graft Material (Histological)|histologic determination of % residual bone graft material|18-20 weeks after ridge preservation||||% residual graft material||Standard Deviation|Mean
2551979|NCT02802319|Primary|% Vital Bone Formation (Histological)|histologic determination of % vital bone formation|18-20 weeks after ridge preservation||||% vital bone||Standard Deviation|Mean
2551980|NCT02801942|Secondary|Number of Participants Who Appreciated Receiving Study Feedback|Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. Participants who appreciated receiving study feedback have been presented.|Up to Day 4|Safety Population|||Participants|||Count of Participants
2551981|NCT02801942|Secondary|Number of Participants Who Were Encouraged to be Included in Study for iLN Biopsy|Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. Participants who were encouraged in study for iLN biopsy have been presented.|Up to Day 4|Safety Population|||Participants|||Count of Participants
2551982|NCT02801942|Secondary|Number of Participants Who Considered to Undergo Lymph Node Biopsy Procedure Another Time|Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who considered to undergo procedure another time have been presented.|Up to Day 4|Safety Population|||Participants|||Count of Participants
2551983|NCT02801942|Secondary|Number of Participants With Aspects Better Explained About the Lymph Node Biopsy Procedure|"Participants were asked to complete Post-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The aspects better explained were as follows; itself, anesthetic procedure, after-care, none and any other procedure not listed above was categorized as other."|Up to Day 4|Safety Population|||Participants|||Count of Participants
2551984|NCT02801942|Secondary|Number of Participants Looking Forward to Undergo the Procedure|Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants looking forward to undergo the procedure have been presented.|Up to Day 4|Safety Population|||Participants|||Count of Participants
2551985|NCT02801942|Secondary|Number of Participants With Extreme Anxiety Towards the Lymph Node Biopsy|Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants with extreme anxiety towards the procedure have been presented.|Up to Day 4|Safety Population|||Participants|||Count of Participants
2551986|NCT02801942|Secondary|Number of Participants With Different Reasons for Participating in the Study|"Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The different reasons have been listed as follows; have friend with diabetes mellitus (DM)/ to progress knowledge, to improve medicines development, participating in the study because of the honorarium, any other reason not listed above was categorized as other and participants having all three reasons as listed above to participate in the study were included in All reasons category"|Up to Day 4|Safety Population|||Participants|||Count of Participants
2551987|NCT02801942|Secondary|Number of Participants Undergoing iLN Biopsy Under Local Anesthetics|Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who underwent iLN biopsy under local anesthetics have been presented.|Up to Day 4|Safety Population|||Participants|||Count of Participants
2551988|NCT02801942|Secondary|Number of Participants Undergoing Procedure Under Local Anesthetics|Participants were asked to complete Pre-Biopsy Lymph Node Questionnaire about their expectations/experiences of undergoing the procedure of FNA biopsy followed by core needle biopsy. The number of participants who underwent procedure under local anesthetics have been presented.|Up to Day 4|Safety Population|||Participants|||Count of Participants
2551989|NCT02801942|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect or other situations.|Up to Day 14|Safety Population|||Participants|||Count of Participants
2551990|NCT02801942|Secondary|Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN Core Biopsies and iLN FNA|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|Biopsy session on Day 1|Safety Population|||Percentage of total memory Conv cells||Standard Error|Least Squares Mean
2553096|NCT02783170|Primary|Feasibility Reported as Percentage of Timely Collected Biospecimens|Timeliness is defined as collected within the visit window|Approximately 1 year|Safety Population - subjects randomized and received study intervention|||percentage of samples|||Number
2551991|NCT02801942|Secondary|Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN Core Biopsies and iLN FNA|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|Biopsy session on Day 1|Safety Population|||Percentage of total Conv T cells||Standard Error|Least Squares Mean
2551992|NCT02801942|Secondary|Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN Core Biopsies and iLN FNA|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|Biopsy session on Day 1|Safety Population|||Percentage of T Reg cells||Standard Error|Least Squares Mean
2551993|NCT02801942|Secondary|Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN Core Biopsies and iLN FNA|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|Biopsy session on Day 1|Safety Population|||Percentage of CD8 T cells||Standard Error|Least Squares Mean
2551994|NCT02801942|Secondary|Percentage of Leukocyte Subsets Including Reg T Cells in iLN Core Biopsies and iLN FNA|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|Biopsy session on Day 1|Safety Population|||Percentage of CD4 T cells||Standard Error|Least Squares Mean
2551995|NCT02801942|Secondary|Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN Core Biopsies and iLN FNA|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.|Biopsy session on Day 1|Safety Population|||Percentage of total memory Reg T cells||Standard Error|Least Squares Mean
2551996|NCT02801942|Secondary|Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH17 Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN Core Biopsies and iLN FNA|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|Biopsy session on Day 1|Safety Population|||Percenatge of total memory Conv T cells||Standard Error|Least Squares Mean
2551997|NCT02801942|Secondary|Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN Core Biopsies and iLN FNA|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|Biopsy session on Day 1|Safety Population|||Percentage of total Conv T cell||Standard Error|Least Squares Mean
2551998|NCT02801942|Secondary|Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in iLN Core Biopsies and iLN FNA|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|Biopsy session on Day 1|Safety Population|||Percentage of TFH cells||Standard Error|Least Squares Mean
2551999|NCT02801942|Secondary|Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cell-like Reg T Cells in iLN Core Biopsies and iLN FNA|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.|Biopsy session on Day 1|Safety Population|||Percentage of TFH cell-like Reg T Cells||Standard Error|Least Squares Mean
2552000|NCT02801942|Secondary|Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 in iLN Core Biopsies and iLN FNA|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|Biopsy session on Day 1|Safety Population|||Percentage of CD8 T cells||Standard Error|Least Squares Mean
2552001|NCT02801942|Secondary|Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN Core Biopsies and iLN FNA|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates data was not available.|Biopsy session on Day 1|Safety Population|||Percentage of monocytes||Standard Error|Least Squares Mean
2552002|NCT02801942|Secondary|Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN Core Biopsies and iLN FNA|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|Biopsy session on Day 1|Safety Population|||Percentage of total dendritic cells||Standard Error|Least Squares Mean
2552003|NCT02801942|Secondary|Percentage of Leukocyte Subsets Including CD56+CD16+, CD56br NK Cells CD56lo CD16+ and CD56lo CD16- in iLN Core Biopsies and iLN FNA|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.|Biopsy session on Day 1|Safety Population|||Percentage of NK cells||Standard Error|Least Squares Mean
2552004|NCT02801942|Secondary|Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16, Dendritic Cells, NK Cells in iLN Core Biopsies and iLN FNA|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.|Biopsy session on Day 1|Safety Population|||Percentage of mononuclear cells||Standard Error|Least Squares Mean
2552046|NCT02801617|Primary|Number of Adverse Events.|"the two periods of PRO-067 of each sequence were grouped as well as those of GAAP to form two comparative groups of adverse events in each intervention. (PRO-067 vs. GAAP ofteno).~The number of adverse events presented throughout the study was evaluated with each study drug to make the comparison between groups."|it is evaluated from the baseline visit (day 1) to the security call (day 75)|intention-to-treat (ITT), all those subjects who received at least one dose of the investigational drugs were considered for the statistical analysis, having a total of 107 cases by intention to treat.|||adverse events|||Number
2552005|NCT02801942|Secondary|Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN Core Biopsies and iLN FNA|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.|Biopsy session on Day 1|Safety Population|||Percentage of B lymphocytes||Standard Error|Least Squares Mean
2552006|NCT02801942|Primary|Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in iLN|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|Biopsy session on Day 1|Safety Population|||Percentage of total memory Conv T cells||Standard Error|Least Squares Mean
2552007|NCT02801942|Primary|Percentage of Leukocyte Subsets Including CD15s+ Memory Conv T Cells, CD69+ Memory Conv T Cells, Helios+ Memory Conv T Cells and Ki67+ Memory Conv T Cells in Blood|Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.|Pre Biopsy session on Day 1|Safety Population|||Percentage of total memory Conv T cells||Standard Error|Least Squares Mean
2552008|NCT02801942|Primary|Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in iLN|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|Biopsy session on Day 1|Safety Population|||Percentage of total Conv T cells||Standard Error|Least Squares Mean
2552009|NCT02801942|Primary|Percentage of Leukocyte Subsets Including CD15s+ Conv T Cells, CD69+ Conv T Cells, Helios+ Conv T Cells and Ki67+ Conv T Cells in Blood|Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.|Pre Biopsy session on Day 1|Safety Population|||Percentage of total Conv T cells||Standard Error|Least Squares Mean
2552010|NCT02801942|Primary|Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in iLN|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|Biopsy session on Day 1|Safety Population|||Percentage of T Reg cells||Standard Error|Least Squares Mean
2552011|NCT02801942|Primary|Percentage of Leukocyte Subsets Including CD15s+ Reg T Cells, CD69+ Reg T Cells, Helios+ Reg T Cells, Ki67+ T Reg Cells, Memory Reg T Cells and Resting Reg T Cells in Blood|Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|Pre Biopsy session on Day 1|Safety Population|||Percentage of T Reg cells||Standard Error|Least Squares Mean
2552610|NCT02792062|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) or Serious TEAEs.||Day 1 up to 12 days after the last dose of study drug (Day 41)|The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.|||participants|||Number
2552012|NCT02801942|Primary|Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in iLN|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|Biopsy session on Day 1|Safety Population|||Percentage of CD8 T cells||Standard Error|Least Squares Mean
2552013|NCT02801942|Primary|Percentage of Leukocyte Subsets Including CD69+ CD8 and Antigen Ki67 (Ki67)+ CD8 in Blood|Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.|Pre Biopsy session on Day 1|Safety Population|||Percentage of CD8 T cells||Standard Error|Least Squares Mean
2552014|NCT02801942|Primary|Percentage of Leukocyte Subsets Including Reg T Cells in iLN|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.|Biopsy session on Day 1|Safety Population. Only those participants with data available at specified time point were analyzed.|||Percentage of CD4 T cells||Standard Error|Least Squares Mean
2552015|NCT02801942|Primary|Percentage of Leukocyte Subsets Including Reg T Cells in Blood|Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T Reg cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.|Pre Biopsy session on Day 1|Safety Population|||Percentage of CD4 T cells||Standard Error|Least Squares Mean
2552016|NCT02801942|Primary|Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in iLN|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.|Biopsy session on Day 1|Safety Population|||Percentage of total memory Reg T cells||Standard Error|Least Squares Mean
2552017|NCT02801942|Primary|Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 Cells, TH1 TH2 Cells, TH17 Cells, TH2 Cells and TH22 Cells-like Reg T Cells in Blood|Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not availble. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|Pre Biopsy session on Day 1|Safety Population|||Percentage of total memory Reg T cells||Standard Error|Least Squares Mean
2552018|NCT02801942|Primary|Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in iLN|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|Biopsy session on Day 1|Safety Population|||Percenatge of total memory Conv T cells||Standard Error|Least Squares Mean
2552047|NCT02801617|Primary|Target Intraocular Pressure (TIOP)|Target Intraocular Pressure (TIOP): Efficacy of experimental drug or active comparator to maintain the IOP in a range at which a patient is likely to remain stable or at which worsening of glaucoma will be slow enough that the risk of additional intervention is not justified.The upper limit of intraocular pressure is: TIOP + 2 mmHg. The measurement of the TIOP in each treatment period.|the baseline visit (day 0), Cross Over Visit (day 30) and the final visit (day 60) for both sequences|by Protocol|||mmHg||Standard Deviation|Mean
2552019|NCT02801942|Primary|Percentage of Leukocyte Subsets Including TFH Cells, PD-1+ ICOS+ TFH Cells, Type 17 T Helper (TH17) Cells, TH1 Cells, TH1 TH17 Cells, TH1 TH17 TH2 T Cells, TH1 TH2 Cells, TH2 Cells, and TH22 Cells in Blood|Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|Pre Biopsy session on Day 1|Safety Population|||Percentage of total memory Conv T cells||Standard Error|Least Squares Mean
2552020|NCT02801942|Primary|Percentage of Leukocyte Subsets Including Central Memory Conv T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in iLN|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.|Biopsy session on Day 1|Safety Population|||Percentage of total Conv T cells||Standard Error|Least Squares Mean
2552021|NCT02801942|Primary|Percentage of Leukocyte Subsets Including Central Memory Conventional (Conv) T Cells, Effector Memory Conv T Cells, Naive Conv T Cells and Stem Cell Memory-like Conv T Cells in Blood|Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.|Pre Biopsy session on Day 1|Safety Population|||Percentage of total Conv T cells||Standard Error|Least Squares Mean
2552022|NCT02801942|Primary|Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in iLN|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.|Biopsy session on Day 1|Safety Population. Only those participants with data available at specified time point were analyzed.|||Percentage of TFH cells||Standard Error|Least Squares Mean
2552023|NCT02801942|Primary|Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cells in Blood|Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.|Pre Biopsy session on Day 1|Safety Population. Only those participants with data available at specified time point were analyzed.|||Percentage of TFH cells||Standard Error|Least Squares Mean
2552024|NCT02801942|Primary|Percentage of Leukocyte Subsets Including PD-1+ ICOS+ TFH Cell-like Reg T Cells in iLN|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. NA indicates that data was not available.|Biopsy session on Day 1|Safety Population. Only those participants with data available at specified time point were analyzed.|||Percentage of TFH cell-like Reg T cells||Standard Error|Least Squares Mean
2552025|NCT02801942|Primary|Percentage of Leukocyte Subsets Including Programmed Death 1 (PD-1)+ Inducible Costimulator (ICOS)+ Follicular Helper T (TFH) Cell-like Regulatory (Reg) T Cells in Blood|Peripheral blood samples were planned to be collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Results could not be presented as data were not collected for this analysis due to lack of model convergence or model reliability|Pre Biopsy session on Day 1|Safety Population. Data were not collected due to lack of model convergence or model reliability.||||||
2552026|NCT02801942|Primary|Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in iLN|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.|Biopsy session on Day 1|Safety Population|||Percentage of CD8 T cells||Standard Error|Least Squares Mean
2552048|NCT02801578|Primary|Participants With >/= 95 % Bruton's Tyrosine Kinase (BTK) Occupancy|BTK occupancy level measured by fluorescent affinity probe just before dosing and at 4 and 24 hours post-dosing on days 1, 8, and 28 (but before the first dose of the next cycle) of each cycle.|3 cycles, up to 90 days||||Participants|||Count of Participants
2552027|NCT02801942|Primary|Percentage of Leukocyte Subsets Including CD45RA+ Effector Memory CD8, Central Memory CD8, Effector Memory CD8, Naive CD8 and Stem Cell Memory-like CD8 Cells in Blood|Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from T cell Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.|Pre Biopsy session on Day 1|Safety Population|||Percentage of CD8 T cells||Standard Error|Least Squares Mean
2552028|NCT02801942|Primary|Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes and CD16+ Monocytes in iLN|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.|Biopsy session on Day 1|Safety Population|||Percentage of monocytes||Standard Error|Least Squares Mean
2552029|NCT02801942|Primary|Percentage of Leukocyte Subsets Including CD14+ CD16+ Monocytes, CD14+ Monocytes, and CD16+ Monocytes in Blood|Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. NA indicates that data was not available.|Pre Biopsy session on Day 1|Safety Population|||Percentage of monocytes||Standard Error|Least Squares Mean
2552030|NCT02801942|Primary|Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in iLN|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|Biopsy session on Day 1|Safety Population|||Percentage of total dendritic cells||Standard Error|Least Squares Mean
2552031|NCT02801942|Primary|Percentage of Leukocyte Subsets Including Myeloid Dendritic Cells and Plasmacytoid Dendritic Cells in Blood|Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA.|Pre Biopsy session on Day 1|Safety Population|||Percentage of total dendritic cells||Standard Error|Least Squares Mean
2552032|NCT02801942|Primary|Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells CD56lo CD16+ and CD56lo CD16- in iLN|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.|Biopsy session on Day 1|Safety Population|||Percentage of NK cells||Standard Error|Least Squares Mean
2552033|NCT02801942|Primary|Percentage of Leukocyte Subsets Including CD56+CD16+, CD56bright NK Cells, CD56lo CD16+ and CD56lo CD16- in Blood|Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not available.|Pre Biopsy session on Day 1|Safety Population|||Percentage of NK cells||Standard Error|Least Squares Mean
2552034|NCT02801942|Primary|Percentage of Leukocyte Subsets Including B-cells, CD56+ CD16+, CD56bright NK Cells, CD56lo CD16+, CD56lo CD16-, Dendritic Cells, NK Cells in iLN|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.|Biopsy session on Day 1|Safety Population|||Percentage of mononuclear cells||Standard Error|Least Squares Mean
2552116|NCT02799069|Secondary|Local Skin Reactions During Second Photodynamic Therapy (PDT-2) for Retreated Subjects|Local skin reactions in the treatment area as assessed by the investigator during PDT-2; only applicable for subjects who were retreated with a second PDT due to remaining lesions 12 weeks after the first PDT (subjects with data).|during PDT treatment [3 h - 4 h ]|Safety Population - retreated subjects only|||percentage of patients|||Number
2552035|NCT02801942|Primary|Percentage of Leukocyte Subsets Including B-cells, Clusters of Differentiation 56 Positive (CD56+) CD16+ , CD56bright Natural Killer (NK) Cells, CD56lo CD16+, CD56lo CD16 Negative (CD56lo CD16-), Dendritic Cells, NK Cells in Blood|Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. NA indicates that data was not available.|Pre Biopsy session on Day 1|Safety Population|||Percentage of mononuclear cells||Standard Error|Least Squares Mean
2552036|NCT02801942|Primary|Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in iLN|Samples were collected including up to two FNA passages of iLN and up to five core biopsies of iLN at the indicated time point from both healthy and NOT1D participants for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.|Biopsy session on Day 1|Safety Population|||Percentage of B lymphocytes||Standard Error|Least Squares Mean
2552037|NCT02801942|Primary|Percentage of Leukocyte Subsets Including B Lymphocytes, Classical B Lymphocytes, Double Negative B Lymphocytes, Naive B Lymphocytes, Plasmablast and Transitional B Lymphocytes in Blood|Peripheral blood samples were collected from both healthy and NOT1D participants at the indicated time points for the analysis of leukocyte subsets from Monocyte Panel. Candidate biomarkers associated with either location of cells and/or disease-status were identified using flow cytometry technique. Generalized linear mixed models were used to analyze data separately for each flow cytometry cell type to provide estimates for comparisons. Fixed categorical were group, sample type, and the interaction of group with sample type, where Group was HV or NOT1D, and sample type was peripheral blood, core biopsy or FNA. The analysis was based upon Safety Population which comprised of all participants who complete any study assessment. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles). NA indicates that data was not available.|Pre Biopsy session on Day 1|Safety Population|||Percentage of B lymphocytes||Standard Error|Least Squares Mean
2552038|NCT02801877|Primary|GAD-7 (Generalized Anxiety Disorder Scale-7) - Anxiety Severity|The GAD-7 is a self-administered 7 item instrument that uses some of the DSM-V criteria for GAD (General Anxiety Disorder) to identify probable cases of GAD along with measuring anxiety symptom severity. GAD-7 total score for the seven items ranges from 0 to 21. Higher values represent a worse outcome. Specifically, scores of 1-4 indicate minimal anxiety symptoms; 5-9 is mild anxiety symptoms; 10-14 is moderate anxiety symptoms; and 15-21 is severe anxiety symptoms.|Measured at start of treatment (baseline), week 4, week 8, month 3, and month 6.|Participants with at least one follow-up measure of self-reported anxiety|||score on a scale||Standard Error|Least Squares Mean
2552039|NCT02801877|Primary|Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity|The PHQ-9 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-27. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-27 is severe.|Measured at start of treatment (baseline), week 4, week 8, month 3, and month 6.|Participants with at least one follow-up measure of self-reported depression|||score on a scale||Standard Error|Least Squares Mean
2552040|NCT02801877|Primary|Adherence to the Mobile Application Intervention|Defined as the median time to last engagement with the mobile application suite within 8 weeks of trial|Participants will be followed for the duration of the 8 week trial||||days||Inter-Quartile Range|Median
2552041|NCT02801617|Secondary|Percentage of Participants With Hyperemia|the hyperemia of the study subjects was evaluated, during the baseline, crossover and final visit, the variable was described as a scale of: absent, very mild, mild, moderate and severe, according to the case, in both groups. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences.|basal visit (day 1), Crossover visit (day 30) and final visit (day 60)|Analysis by protocol|||percentage of patients with hyperemia|||Number
2552042|NCT02801617|Secondary|Percentage of Participants With Chemosis|The chemosis will be measured as present / absent according to each case. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences.|basal visit (day 1), Crossover visit (day 30) and final visit (day 60)|Analysis by protocol|||percentage of patients with chemosis|||Number
2552043|NCT02801617|Secondary|Percentage of Participants With Tearing|The tearing will be measured as present / absent according to each case. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences.|basal visit (day 1), Crossover visit (day 30) and final visit (day 60)|Analysis by protocol|||percentage of patients with tearing|||Number
2552044|NCT02801617|Secondary|Percentage of Participants With Foreign Body Sensation|The foreign body sensation will be measured as present / absent according to each case. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences.|basal visit (day 1), Crossover visit (day 30) and final visit (day 60)|Analysis by protocol|||percentage of patients with Foreign body|||Number
2552045|NCT02801617|Secondary|Percentage of Ocular Burning|the ocular burning of the study subjects was evaluated, during the baseline, crossover and final visit, the variable was described as present or absent, according to the case, in both groups. A Pearson´s chi-square test is performed in the crossover and final visit to compare the end of periods 1 and 2 between both study sequences.|at the basal visit (day 1) crossover visit (day 30) and final visit (day 60)|analysis by protocol|||percentage of Ocular burning|||Number
2552049|NCT02801396|Primary|Percentage of Eyes With Acceptable Cosmetic Lens Fit|Cosmetic lens fitting is assessed for each subject eye in the primary gaze position without a slit lamp. Cosmetic lens fit is a binary response and is reported as acceptable or unacceptable. The Percentage of subject eyes with acceptable cosmetic lens fitting is reported.|30 Minutes Post Insertion|Subjects that completed all study visits without a major protocol deviation.|||Percentage of eyes|Eyes||Number
2552050|NCT02801396|Primary|Percentage of Eyes With Acceptable Mechanical Lens Fit|Mechanical lens fit will be assessed for each subject and eye using a slit lamp. Lens fit is a binary response and 'Yes' = Acceptable Fit and 'No' = Unacceptable Fit. Lens fit is assessed using Lens centration, limbal exposure, primary gaze movement, up-gaze movement, edge lift, lens tightness. Unacceptable fit will be declared if there is any of the following present: limbal exposure, edge lift, excessive movement in primary or up-gaze or insufficient movement in primary gaze and up-gaze. The Percentage of subject eyes with acceptable lens fit will be reported.|30 Minutes Post Insertion|Subjects that completed all study visits without a major protocol deviation.|||Percentage of eyes|Eyes||Number
2552051|NCT02801396|Primary|Visual Performance (LogMar)|Distance time controlled Visual Performance (LogMAR) was assessed for each subject eye under bright-illumination high-contrast lighting conditions at 4m using an ETDRS chart. The average visual performance (LogMAR) was reported for each study lens.|30 Minutes Post Insertion|Subjects that completed all study visits without a major protocol deviation.|||LogMAR|Eyes|Standard Deviation|Mean
2552052|NCT02801396|Primary|CLUE Handling|CLUE Handling is assessed using the Contact Lens User Experience (CLUE™) Questionnaire. CLUE™ is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable / positive response. 97% of the scores fall within 0 and 120 (mean +/- 3XSD).|30 Minutes Post Insertion|Subjects that completed all study visits without a major protocol deviation.|||Units on a scale||Standard Deviation|Mean
2552053|NCT02801006|Primary|Overall Satisfaction|Overall satisfaction for stenfilcon A and etafilcon A toric lens pair is assessed. scale 0-10, 0=extremely un-satisfy, 10=very satisfy|2 weeks||||units on a scale|eyes|Standard Deviation|Mean
2552054|NCT02801006|Primary|Lens Handling|Lens handling for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=cannot handle at all, 10=no problem at all|2 weeks||||units on a scale|eyes|Standard Deviation|Mean
2552055|NCT02801006|Primary|Stability of Vision|Stability of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=unstable vision and cannot see at all, 10=always stable vision|2 weeks||||units on a scale|eyes|Standard Deviation|Mean
2552056|NCT02801006|Primary|Clarity of Vision|Clarity of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=blur vision and cannot see at all, 10=very clear with no blur vision at all|2 weeks||||units on a scale|eyes|Standard Deviation|Mean
2552057|NCT02801006|Primary|Dryness|Dryness (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=extremely dried and cannot wear lens, 10=feel no dryness at all|2 weeks||||units on a scale|eyes|Standard Deviation|Mean
2552058|NCT02801006|Primary|Comfort|Wearing comfort (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0= extremely uncomfortable cannot wear at all, 10=very comfortable and feel no lens at all|2 weeks||||units on a scale|eyes|Standard Deviation|Mean
2552059|NCT02800928|Primary|Number of Cigarettes Smoked|Number of cigarettes smoked during the self administration period|60 min||||number of cigarettes||Standard Error|Mean
2552060|NCT02800928|Primary|Latency|Latency (in minutes and seconds) to time of first cigarette smoking during the delay period|50 min|13 subjects completed study (i.e., completed both CERC-501 and Placebo periods in this cross over design).|||minutes||Standard Error|Mean
2552061|NCT02800356|Secondary|Intraocular Pressure|Intraocular pressure was recorded.|4 weeks and 12 weeks||||mmHg||Standard Deviation|Mean
2552062|NCT02800356|Secondary|Presence of Haemorrhage, Photocoagulation Spots, Ischemic Areas|Fundus examination by using slit-lamp was performed in order to assess the presence of hemorrhage, photocoagulation spots, ischemic areas|4 weeks and 12 weeks||||Participants|||Count of Participants
2552063|NCT02800356|Secondary|Adverse and Serious Adverse Events|Adverse and Serious Adverse Events were recorded|4 weeks and 12 weeks||||Participants|||Count of Participants
2552064|NCT02800356|Secondary|The Thickness of the Outer Nuclear Layer in the Treated Area|The thickness of the outer nuclear layer in the treated area was measured using structural OCT|Baseline, 4 weeks and 12 weeks||||µm||Standard Deviation|Mean
2552065|NCT02800356|Secondary|Visual Acuity|Change in mean Visual Acuity|Baseline, 4 weeks and 12 weeks||||LogMAR||Standard Deviation|Mean
2552066|NCT02800356|Primary|Retinal Sensitivity|Change in retinal sensitivity on customized microperimetry (treated area).|Baseline, 4 weeks and 12 weeks||||dB||Standard Deviation|Mean
2552067|NCT02800213|Primary|Received Tidal Volume|Mean received tidal volume for 30 breaths delivered by the subjects over three minutes as measured via the RespiTrainer Advance manikin model monitor output.|3 minutes||||milliliters||95% Confidence Interval|Mean
2552068|NCT02799784|Primary|Trough Forced Expiratory Volume in One Second (FEV1) at Week 8|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 was defined as 23 and 24 hour post-dose FEV1 measurements. All par. in the Intent To Treat (ITT) Population who were not identified as full protocol deviators were included in Per-Protocol (PP) Population. ITT Population, comprised of all randomized subjects, who received at least one dose of study medication.|Week 8|Per Protocol Population|||Liters||Standard Error|Least Squares Mean
2552075|NCT02799472|Secondary|Number of Participants Who Tested Positive for Anti-GSK3196165 Binding Antibody Detection at Any Time Post-Baseline|Immunogenicity samples for determination of anti-drug-antibody (ADA) were collected. The presence of treatment emergent ADA was determined using a GSK3196165 bridging style ADA assay with a bio-analytically determined cut point determined during assay validation. Samples taken after dosing with GSK3196165 that had a value at or above the cut-point was considered potentially treatment-emergent ADA-positive. The immunogenicity population consisted of all participants in the ITT population, who had at least one valid immunogenicity assessment.|Up to 12-Week FU (Week 22)|Immunogenicity Population|||Participants|||Count of Participants
2552069|NCT02799472|Secondary|Change From Baseline in Erosion as Assessed by RAMRIQ Assessment in the Most Affected Hand/Wrist|RAMRIQ is an automated volume quantification assessment for erosion volume. RAMRIQ assessed the same pathologies and joints (except MCP1) as RAMRIS, allowing for direct comparison of results obtained using the two methods. Bones were automatically identified in pre-contrast, coronal T1 images using AAMs. Joint capsules and soft tissues were also segmented with AAMs, providing consistent 3D ROI for synovial enhancement across all time points. Erosion volume was identified inside the bone surfaces using voxel-based classification. The volume of BME and erosions was normalised to total bone volume for statistical analysis. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 4, 12 and 12-Week FU (Week 22)|ITT Population.|||Milliliters||Standard Error|Least Squares Mean
2552070|NCT02799472|Secondary|Change From Baseline in Osteitis as Assessed by RAMRIQ Assessment in the Most Affected Hand/Wrist|RAMRIQ is an automated volume quantification assessment for edema volume. RAMRIQ assessed the same pathologies and joints (except MCP1) as RAMRIS, allowing for direct comparison of results obtained using the two methods. Bones were automatically identified in pre-contrast, coronal T1 images using AAMs. Joint capsules and soft tissues were also segmented with AAMs, providing consistent 3D ROI for synovial enhancement across all time points. Edema volume was defined as non-erosion contrast-enhancing voxels inside the bone. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 4, 12 and 12-Week FU (Week 22)|ITT Population.|||Milliliters||Standard Error|Least Squares Mean
2552071|NCT02799472|Secondary|Change From Baseline in Synovitis as Assessed by Rheumatoid Arthritis MRI Quantitative (RAMRIQ) Assessment in the Most Affected Hand/Wrist|RAMRIQ is an automated volume quantification assessment. RAMRIQ assessed same pathologies and joints (except metacarpophalangeal joint [MCP1]) as RAMRIS allowing for direct comparison of results obtained using the two methods. Bones were automatically identified in pre-contrast, coronal T1 images using active appearance modelling (AAMs). Joint capsules and soft tissues were also segmented with AAMs, providing consistent 3D regions of interest (ROI) for synovial enhancement across all time points. Synovial volume was calculated as voxels that enhance within each ROI. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. Repeated measures analysis adjusted for Synovitis baseline value, treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 4, 12 and 12-Week FU (Week 22)|ITT Population.|||Milliliters||Standard Error|Least Squares Mean
2552072|NCT02799472|Secondary|Change From Baseline in Erosion as Assessed by OMERACT RAMRI Scoring System in the Most Affected Hand/Wrist|For bone erosion a total of 25 locations were evaluated. Individual location scores range from 0-10, where, 0: no erosion; 1: 1-10% of bone eroded and 10: 91-100% of bone eroded. The final bone erosion score is the sum of the individual location scores. The total score ranged from 0 (best) to 250 (worst). If an individual location was scored either 'Not Visible' or 'Surgically Modified' or 'Not Assessable' then the score for that location was set to be missing. Missing joint scores was imputed as the mean of the non-missing location scores. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. Analysis was performed using repeated measures analysis adjusted for Bone Erosion Score baseline value, treatment group, disease duration (<=2 or >2 years), visit and treatment group. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles.|Baseline and Weeks 4, 12, 12-Week FU (Week 22)|ITT Population.|||Scores on a scale||Standard Error|Least Squares Mean
2552073|NCT02799472|Secondary|Change From Baseline in Osteitis as Assessed by OMERACT RAMRI Scoring System in the Most Affected Hand/Wrist|For bone edema/osteitis a total of 25 locations was evaluated. Individual location scores ranged from 0-3, where, 0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100% of bone edematous. Final bone edema/osteitis score is sum of individual location scores. Total score ranged from 0 (best) to 75 (worst). Baseline was defined at Day 1. Change from Baseline was calculated by subtracting post-dose value from Baseline value. If an individual location was scored either 'Not Visible' or 'Surgically Modified' or 'Not Assessable' then the score for that location was set to be missing. Missing joint scores was imputed as mean of non-missing location scores. Repeated measures analysis adjusted for Bone Edema/Osteitis Score baseline value, treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 4, 12, 12-Week FU (Week 22)|ITT Population.|||Scores on a scale||Standard Error|Least Squares Mean
2552074|NCT02799472|Secondary|Change From Baseline in Synovitis as Assessed by Outcome Measures in Rheumatology (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) in the Most Affected Hand/Wrist|For synovitis a total of 8 joints were evaluated. Individual joint scores range from 0-3, where 0= normal, 1=mild, 2=moderate and 3=severe. The final synovitis score is the sum of the individual joint scores. Total score range from 0 (best) to 24 (worst). If an individual location is scored either 'Not Visible' or 'Surgically Modified' then the score for that location was set to missing. Missing joint scores was imputed as the mean of the non-missing joint scores. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. Repeated measures analysis adjusted for synovitis score baseline value, treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Data has been presented for Median and 95% credible interval. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 4, 12, 12-Week FU (Week 22)|ITT Population.|||Scores on a scale||95% Confidence Interval|Median
2552117|NCT02799069|Secondary|Local Skin Reactions During First Photodynamic Therapy (PDT-1)|Local skin reactions in the treatment area as assessed by the investigator during the first PDT (PDT-1)|during PDT treatment [3 h - 4 h ]|Safety Population|||percentage of patients|||Number
2552649|NCT02791763|Secondary|Number of ND Participants Who Had an Hgb Level of More Than 13.0 g/dL|Number of ND participants who had an Hgb level of more than 13.0 g/dL is presented.|Up to week 52|ITT Population|||Participants|||Count of Participants
2552076|NCT02799472|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect and associated with liver injury and impaired liver function. An AESI include serious infections, opportunistic infections, neutropenia, respiratory events, pulmonary alveolar proteinosis, hypersensitivity reactions, injection site reactions, persistent cough or dyspnea.|Up to 12-Week FU (Week 22)|ITT Population|||Participants|||Count of Participants
2552077|NCT02799472|Primary|Change From Baseline in Safety Biomarkers: KL-6 Antigen|Blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Safety biomarker included analysis of KL-6 Antigen. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Week 12, 12-Week FU (Week 22)|ITT Population.|||Ratio of safety biomarker||Geometric Coefficient of Variation|Geometric Mean
2552078|NCT02799472|Primary|Change From Baseline in Safety Biomarkers: 3B-Cholestenoic Acid, Surfactant Protein D|Blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Safety biomarkers included analysis of 3B-Cholestenoic Acid and Surfactant Protein D. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Week 12, 12-Week FU (Week 22)|ITT Population.|||Ratio of safety biomarker||Geometric Coefficient of Variation|Geometric Mean
2552079|NCT02799472|Primary|Change From Baseline in Mechanistic Biomarkers|Blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Mechanistic biomarkers included analysis of Interleukin 1 Beta, Interleukin 10, Interleukin 15, Interleukin 17 Alpha, Interleukin 17F, Interleukin 8 and Tumor Necrosis Factor. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. NA indicates that data is not available since 100% of the data was below limit of quantification at all time points. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 1, 2, 4, 6, 8, 12, 12-Week FU (Week 22)|ITT Population.|||Ratio of mechanistic biomarker||Geometric Coefficient of Variation|Geometric Mean
2552080|NCT02799472|Primary|Change From Baseline in Complement Biomarkers: Complement Component 4a (C4a), Complement Component 5a (C5a), Complement Split Factor SC5b-9, Soluble Cluster of Differentiation 163 (sCD163)|Blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Complement biomarkers included analysis of Complement C4a, Complement C5a, Complement Split Factor SC5b-9 and Soluble CD163. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 1, 2, 4, 6, 8, 12, 12-Week FU (Week 22)|ITT Population.|||Ratio of complement biomarker||Geometric Coefficient of Variation|Geometric Mean
2552081|NCT02799472|Primary|Change From Baseline in Complement Biomarkers: Complement Component 3 (C3), Complement Component 4 (C4)|Blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Complement biomarkers included analysis of Complement C3 and Complement C4. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 1, 2, 4, 6, 8, 12, 12-Week FU (Week 22)|ITT Population.|||Ratio of complement biomarker||Geometric Coefficient of Variation|Geometric Mean
2552082|NCT02799472|Primary|Change From Baseline in Flow Cytometry: CD16+ Monocyte Panel: CD14-CD16+CD66b+|Whole blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Flow cytometry assessment included assessment of CD14-CD16+CD66b+ cell. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. Analysis was performed using repeated measures analysis adjusted for CD14-CD16+CD66b+ (10^6/Liter) baseline value, treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 1, 4, 12, 12-Week FU (Week 22)|ITT Population.|||10^6 cells/Liter||Standard Error|Least Squares Mean
2552083|NCT02799472|Primary|Change From Baseline in Flow Cytometry: CD16+ Monocyte Panel: CD14-HLA-DR+CD11cbr+CD123-, CD14br+CD16+, CD14br+CD16-, CD14lo+CD16br+|Whole blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Flow cytometry assessment included assessment of CD14-HLA-DR+CD11cbr+CD123-, CD14br+CD16+, CD14br+CD16- and CD14lo+CD16br+. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. Analysis was performed using repeated measures analysis adjusted for CD14-HLA-DR+CD11cbr+CD123-, CD14br+CD16+, CD14br+CD16- and CD14lo+CD16br+ (10^3/Liter) baseline value, treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 1, 4, 12, 12-Week FU (Week 22)|ITT Population.|||10^3 cells/Liter||Standard Error|Least Squares Mean
2552091|NCT02799472|Primary|Change From Baseline in Predictive Biomarkers: Chitinase 3 Like 1, Matrix Metalloproteinase 3 (MMP-3)|Blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Predictive biomarkers included analysis of Chitinase 3 Like 1 and MMP-3. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for Chitinase 3 Like 1 and MMP-3 log(Baseline value), treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 1, 2, 4, 6, 8, 12, 12-Week FU (Week 22)|ITT Population.|||Ratio of predictive biomarker||Geometric Coefficient of Variation|Geometric Least Squares Mean
2552084|NCT02799472|Primary|Change From Baseline in T Helper Cell Panel Events|Blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. T Helper Cell Panel included analysis of CD45+3+8-4+CCR6+CXCR3+38+DR+, CD45+3+8-4+CCR6+CXCR3-38+DR+, CD45+3+8-4+CCR6-CXCR3+38+DR+, CD45+3+8-4+CCR6-CXCR3-38+DR+, CD45+CD3+CD8-CD4+, CD45+CD3+CD8-CD4+CCR6+CXCR3+, CD45+CD3+CD8-CD4+CCR6+CXCR3-, CD45+CD3+CD8-CD4+CCR6-CXCR3+ and CD45+CD3+CD8-CD4+CCR6-CXCR3-. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. Analysis was performed using repeated measures analysis adjusted for T Helper Cell Panel Events (EVENTS) Baseline value, treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 1, 4, 12, 12-Week FU (Week 22)|ITT Population.|||Events||Standard Error|Least Squares Mean
2552085|NCT02799472|Primary|Change From Baseline in Flow Cytometry: T Reg Cell Foxp3: CD3+CD4+CD25+CD127-, CD3+CD4+foxP3+CD25+CD127-|Whole blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Flow cytometry assessment included assessment of CD3+CD4+CD25+CD127- and CD3+CD4+foxP3+CD25+CD127-. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. Analysis was performed using repeated measures analysis adjusted for CD3+CD4+CD25+CD127- and CD3+CD4+foxP3+CD25+CD127-Number of Cells (10^6 cells/L) log(Baseline value), treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 1, 4, 12, 12-Week FU (Week 22)|ITT Population.|||10^6 cells/Liter||Standard Error|Least Squares Mean
2552086|NCT02799472|Primary|Change From Baseline in Flow Cytometry: T Regulatory (Reg) Cell Foxp3- CD3+ CD4+, CD3+ CD8+ and CD3+|Whole blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Flow cytometry assessment included assessment of CD3+ CD4+, CD3+ CD8+ and CD3+. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for CD3+ CD4+, CD3+ CD8+ and CD3+ Number of Cells (10^6/L) log(Baseline value), treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 1, 4, 12, 12-Week FU (Week 22)|ITT Population.|||Ratio of T Reg cell||Geometric Coefficient of Variation|Geometric Least Squares Mean
2552087|NCT02799472|Primary|Change From Baseline in Flow Cytometry: 6 Colour TBNK Panel- CD3+CD8+ and T Cell B Cell Natural Killer Lymphocytes (NKL)|Whole blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Flow cytometry assessment included assessment of CD3+CD8+ and T Cell B Cell NKL. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-dose value from the Baseline value. Analysis was performed using repeated measures analysis adjusted for CD3+CD8+ and T Cell B Cell NKL log(Baseline value), treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 1, 4, 12, 12-Week FU (Week 22)|ITT Population.|||10^9 cells/Liter||Standard Error|Least Squares Mean
2552088|NCT02799472|Primary|Change From Baseline in Flow Cytometry: 6 Colour TB Natural Killer (NK) Panel- CD16+CD56+, CD19, CD3, CD3+CD4+|Whole blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Flow cytometry assessment included assessment of cluster of differentiation (CD)16+CD56+, CD19, CD3, CD3+CD4+. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Repeated measures analysis adjusted for CD16+CD56+, CD19, CD3, CD3+CD4+, CD3+CD8+ and T Cell B Cell NKL log(Baseline value), treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 1, 4, 12, 12-Week FU (Week 22)|ITT Population.|||Ratio of biomarker||Geometric Coefficient of Variation|Geometric Least Squares Mean
2552089|NCT02799472|Primary|Change From Baseline in Flow Cytometry: Helper/Suppressor Cells|Whole blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Flow cytometry assessment included assessment of Helper/Suppressor. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for Helper/Suppressor log(Baseline value), treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 1, 4, 12, 12-Week FU (Week 22)|ITT Population.|||Ratio of Helper/Suppressor cells||Geometric Coefficient of Variation|Geometric Least Squares Mean
2552090|NCT02799472|Primary|Change From Baseline in Cartilage Biomarkers|Blood samples were collected and analyzed for markers that may be predictive of rheumatoid arthritis disease activity. Cartilage biomarkers included analysis of ARGS Neo-Epitope, Citrullinated MMP-Degraded Vimentin (CMDV), MMP-Degraded C Reactive Protein (CRP), MMP-Degraded Type I Collagen (MD1C), MMP-Degraded Type II Collagen (MD2C), MMP-Degraded Type III Collagen (MD3C). Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for ARGS Neo-Epitope, Citrullinated MMP-Degraded Vimentin, MMP-Degraded CRP, MMP-Degraded Type I Collagen, MMP-Degraded Type II Collagen and MMP-Degraded Type III Collagen log(Baseline value), treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 1, 2, 4, 6, 8, 12, 12-Week FU (Week 22)|ITT Population.|||Ratio of cartilage biomarker||Geometric Coefficient of Variation|Geometric Least Squares Mean
2552113|NCT02799069|Secondary|Local Discomfort - Pain During First Photodynamic Therapy (PDT-1)|Pain (11-point numeric rating scale) by PDT Session; Overall (If both areas have been treated, maximum intensity over both areas is used for analysis.) Patients assessed the pain experienced during PDT using an 11-point numeric rating pain scale (NRPS) ranging from 0 (no pain at all) to 10 (worst possible pain). This score reflects the patient's maximum pain during PDT. This outcome measure shows pain score after the first PDT.|during PDT treatment [3 h - 4 h ]|Safety Population|||units on a scale||Standard Deviation|Mean
2552092|NCT02799472|Primary|Change From Baseline in Predictive Biomarkers: Amyloid A, Chemokine (C-C Motif) Ligand 17, Chemokine (C-X-C Motif) Ligand 13, Interleukin 6, Macrophage-Derived Chemokine|Blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Predictive biomarkers included analysis of Chemokine (C-C Motif) Ligand 17 (CL17), Chemokine (C-X-C Motif) Ligand 13 (CL13), Interleukin 6, Macrophage-Derived Chemokine (MDC). Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for CL17, CL13, Interleukin 6, MDC log(Baseline value), treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data has been presented for only those time points at which the samples were collected.|Baseline and Weeks 1, 2, 4, 6, 8, 12, 12-Week FU (Week 22)|ITT Population.|||Ratio of predictive biomarker||Geometric Coefficient of Variation|Geometric Least Squares Mean
2552093|NCT02799472|Primary|Change From Baseline in Predictive Biomarkers: Amyloid A|Blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Predictive biomarkers included analysis of Amyloid A. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for Amyloid A log(Baseline value), treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data has been presented for only those time points at which the samples were collected.|Baseline and Week 12, 12-Week FU (Week 22)|ITT Population.|||Ratio of predictive biomarker||Geometric Coefficient of Variation|Geometric Least Squares Mean
2552094|NCT02799472|Primary|Change From Baseline in Predictive Biomarkers: 14-3-3 ETA Protein, S100 Calcium Binding Protein (CBP) A8 and A9|Blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Predictive biomarkers included analysis of 14-3-3 ETA Protein, S100 CBP A8 and A9. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for 14-3-3 ETA Protein (mg/L) and S100 CBP A8 and A9 log(Baseline value), treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 1, 2, 4, 6, 8, 12, 12-Week FU (Week 22)|ITT Population.|||Ratio of predictive biomarker||Geometric Coefficient of Variation|Geometric Least Squares Mean
2552095|NCT02799472|Primary|Change From Baseline in Target Engagement Biomarkers- Soluble Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) Complexed to GSK3196165|Blood samples were collected for markers which may influence rheumatoid arthritis. Target engagement biomarkers included soluble GM-CSF complexed to GSK3196165. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for GM-CSF - Complex log(Baseline value), treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Analysis was performed on Intent-to-Treat (ITT) Population which consisted of all participants who were randomized to treatment and who received at least one dose of study treatment. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Weeks 1, 2, 4, 6, 8, 12, 12-Week follow-up (FU) (Week 22)|ITT Population.|||Ratio of GM-CSF complex||Geometric Coefficient of Variation|Geometric Least Squares Mean
2552096|NCT02799082|Secondary|Related Adverse Events /AEs)|Related treatment-emerged-adverse events (TEAEs) until 12 weeks after the last PDT (>=5%) TEAEs were reported from the day of the 1st PDT until the end-of-study (clinical part), i.e. 12 weeks after the last PDT (until 12 weeks after the 1st PDT or up to 24 weeks in case a 2nd PDT was applied).|up to 24 weeks after the 1st PDT|safety population|||Participants|||Count of Participants
2552097|NCT02799082|Secondary|Discomfort During and After PDT|Local discomfort experienced by the patient after illumination were documented in three categories: itching, burning, pain.|during and after PDT [3h - 4 h]|Safety Population (Overall reactions after first and/or second PDT)|||Participants|||Count of Participants
2552098|NCT02799082|Secondary|Local Skin Reactions|Local skin reactions observed immediately after illumination by the investigator were documented using different categories (erythema, edema, induration, vesicles, erosion, ulceration, scaling/flanking, scabbing/crusting,weeping/exudates).|during and after PDT [3h - 4 h]|Safety Population, Overall reactions after first and/or second PDT|||Participants|||Count of Participants
2552099|NCT02799082|Secondary|Overall Cosmetic Outcome 12 Weeks After the Last PDT|Overall Cosmetic Outcome (CO) 12 weeks after PDT (12 weeks after 1st PDT or 12 weeks after 2nd PDT). The cosmetic outcome at the end-of-study visit was calculated on the basis of skin quality assessment: skin surface, hyperpigmentation, hypopigmentation, mottled/irregular pigmentation, degree of scarring, and atrophy. The CO was rated as very good if the sum score of the previously mentioned ratings (all ratings for each sign added up) has improved by at least 2 points as compared to baseline; the CO was rated as good if the sum score at a given visit has improved by at least 1 point as compared to baseline; the cosmetic outcome is rated as satisfactory if the sum score at a given visit is identical to the one at baseline; the cosmetic outcome is rated as unsatisfactory if the sum score at a given visit has worsened by 1 point compared to baseline, the cosmetic outcome is rated as impaired if the sum score at a given visit has worsened by at least 2 points compared to baseline.|12 weeks after the last PDT, up to 24 weeks|FAS|||Participants|||Count of Participants
2552100|NCT02799082|Secondary|Subjects With Partial Clearance 12 Weeks After the Last PDT|Percentage of subjects with clearance of at least 75% of lesions 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).|12 weeks after the last PDT, up to 24 weeks|FAS|||percentage of patients||95% Confidence Interval|Number
2552101|NCT02799082|Secondary|Subjects With Complete Clearance 12 Weeks After the First PDT|AK clearance rate, defined as the number of subjects with complete remission of all AK lesions assessed at 12 weeks after the first PDT|12 weeks after the first PDT|FAS|||percentage of patients||95% Confidence Interval|Number
2552131|NCT02799069|Secondary|Complete Lesion Response Rate 3-4 Weeks After First Photodynamic Therapy (PDT)|Completely cleared individual lesions as defined at 3-4 weeks after first photodynamic therapy (PDT)|3-4 weeks after the first PDT|ITT|||percentage of lesions|number of individual lesions|95% Confidence Interval|Number
2552102|NCT02799082|Secondary|Change in Total Lesion Area 12 Weeks After the Last PDT (Treated Area Scalp)|"Change in mean total lesion area within the target treatment area per subject 12 weeks after the last PDT compared to baseline (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). The outcome measure describes the mean difference between total lesion size at baseline and 12 weeks after the last PDT. Negative values indicate a reduction in the total lesion area size compared to baseline.~Subgroup Analysis for patients with lesions located in the scalp only."|12 weeks after the last PDT, up to 24 weeks|FAS|||mm²||Standard Deviation|Mean
2552103|NCT02799082|Secondary|Change in Total Lesion Area 12 Weeks After the Last PDT (Treated Area Face)|"Change in mean total lesion area within the target treatment area per subject 12 weeks after the last PDT compared to baseline (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). The outcome measure describes the mean difference between total lesion size at baseline and 12 weeks after the last PDT. Negative values indicate a reduction in the total lesion area size compared to baseline.~Subgroup Analysis for patients with lesions located in the face only."|12 weeks after the last PDT, up to 24 weeks|FAS|||mm²||Standard Deviation|Mean
2552104|NCT02799082|Secondary|Change in Total Lesion Size 12 Weeks After the Last PDT|"Change in the mean total lesion area 12 weeks per subject after the last PDT compared to baseline (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).~The outcome measure describes the mean difference between total lesion size at baseline and 12 weeks after the last PDT. Negative values indicate a reduction in the total lesion area size compared to baseline."|12 weeks after the last PDT, up to 24 weeks|FAS (Overall)|||mm²||Standard Deviation|Mean
2552105|NCT02799082|Secondary|Percentage of AK Lesions Showing Complete Remission Treated With Narrow Spectrum Lamp 12 Weeks After the Last PDT|"Percentage of individual lesions completely cleared and with no adherent scaling plaques of AK that were visible any longer 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).~for subgroup analysis: patients treated with narrow spectrum lamp only."|12 weeks after the last PDT, up to 24 weeks|FAS, subgroup: lesions treated with narrow spectrum lamp only|||percentage of lesions|lesions -PDT with narrow spectrum lamp|95% Confidence Interval|Number
2552106|NCT02799082|Secondary|Percentage of AK Lesions Showing Complete Remission 12 Weeks After the Last PDT|Percentage of individual lesions completely cleared and with no adherent scaling plaques of AK that were visible any longer 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment); Overall population|12 weeks after the last PDT, up to 24 weeks|FAS (Overall)|||percentage of lesions|individual lesions|95% Confidence Interval|Number
2552107|NCT02799082|Primary|Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)|"AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).~Analysis was for the subgroup: treated by narrow spectrum lamps only [n=13 (vehicle), n= 28 (BF-200 ALA)]"|12 weeks after the last PDT, up to 24 weeks|PPP; subgroup analysis for patients only treated with narrow spectrum lamps|||percentage of patients||95% Confidence Interval|Number
2552108|NCT02799082|Primary|Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)|"AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).~Analysis was for the subgroup: treated by narrow spectrum lamps only [n=15 (vehicle), n= 31 (BF-200 ALA)]"|12 weeks after the last PDT, up to 24 weeks|FAS; subgroup analysis for patients only treated with narrow spectrum lamps|||percentage of participants||95% Confidence Interval|Number
2552109|NCT02799082|Primary|Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)|AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).|12 weeks after the last PDT, up to 24 weeks|per protocol population (PPP), (Overall)|||percentage of participants||95% Confidence Interval|Number
2552110|NCT02799082|Primary|Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)|AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).|12 weeks after the last photodynamic therapy (PDT), up to 24 weeks|Full analysis set (FAS), Overall|||percentage of participants||95% Confidence Interval|Number
2552111|NCT02799069|Secondary|Adverse Reactions|"Adverse reactions are Treatment-Emergent Adverse Events considered at least possibly related to the treatment with the randomized investigational medicinal products; Adverse reactions are shown with a frequency cut off of >=5%.~TEAEs are considered from subjects who received only one PDT or subjects who received 2 PDTs (initial Treatment (PDT-1) and retreatment (PDT-2) due to remaining lesions 12 weeks after first photodynamic therapy.~The safety set consists of all patients treated at least once with investigational product. Treatment with investigational product consists of application of study drug followed by illumination. This excludes one patient from the safety set; for this patient the investigational product was applied on the skin but it was not illuminated. Patients are treated according to actual treatment."|up to 12 weeks after the last PDT, up to 24 weeks after first treatment|safety population|||Participants|||Count of Participants
2552112|NCT02799069|Secondary|Local Discomfort - Pain During Second Photodynamic Therapy (PDT-2) for Retreated Subjects|"Pain (11-point numeric rating scale) by PDT Session; Overall (If both areas have been treated, maximum intensity over both areas is used for analysis.) Patients assessed the pain experienced during PDT using an 11-point numeric rating pain scale (NRPS) ranging from 0 (no pain at all) to 10 (worst possible pain). This score reflects the patient's maximum pain during PDT.~Only applicable for subjects who received a retreatment (PDT-2) due to remaining lesions 12 weeks after the first treatment (PDT-1) (subjects with data)"|during PDT treatment [3 h - 4 h ]|Safety Population|||units on a scale||Standard Deviation|Mean
2552114|NCT02799069|Secondary|Local Discomfort During Second Photodynamic Therapy (PDT-2) for Retreated Subjects|Local discomfort reported by the patients during Illumination phase of retreatment (PDT-2); only applicable for subjects who received a retreatment (PDT-2) due to remaining lesions 12 weeks after the first treatment (PDT-1) (subjects with data)|during PDT treatment [3 h - 4 h ]|Safety Population - retreated subjects only|||percentage of patients|||Number
2552118|NCT02799069|Secondary|Overall Cosmetic Outcome of the Treated Skin 12 Weeks After Last Photodynamic Therapy (PDT) Compared to Baseline|The cosmetic outcome 12 weeks after the last PDT (12 weeks after 1st PDT for subjects who are completely cleared at this time point, 12 weeks after 2nd PDT for subjects retreated due to remaining lesions 12 weeks after 1st PDT) will be calculated on the basis of the skin quality assessment (skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring, and atrophy) upon visual examination (scale: 0= none, 1= mild, 2= moderate, 3=severe). The cosmetic outcome is rated as very good if the sum score of the previously mentioned ratings (all ratings for each sign added up) has improved by at least 2 points as compared to baseline; as good if the sum score has improved by at least 1 point as compared to baseline; as satisfactory if the sum score is identical to the one at baseline; as unsatisfactory if the sum score has worsened by 1 point compared to baseline and as impaired if the sum score has worsened by at least 2 points compared to baseline.|12 weeks after the last PDT, up to 24 weeks after first treatment|ITT|||percentage of patients||95% Confidence Interval|Number
2552119|NCT02799069|Secondary|Change From Baseline in Total Lesion Area 12 Weeks After Last Photodynamic Therapy (PDT)|the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 12 weeks after last PDT, combining the changes from baseline in total lesion area at 12 weeks after the first PDT and at 12 weeks after the second PDT (a second PDT was applied to subjects with non- or partially responding lesions 12 weeks after the first PDT).|12 weeks after the last PDT, up to 24 weeks after the first treatment|ITT|||percentage of change from baseline||Standard Deviation|Mean
2552120|NCT02799069|Secondary|Change From Baseline in Total Lesion Area 3-4 Weeks After Last Photodynamic Therapy (PDT)|the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 3-4 weeks after last PDT, combining the changes from baseline in total lesion area of subjects 3-4 weeks after first PDT and second PDT (a second PDT was applied for subjects who showed non- or partially responding lesions 12 weeks after the first PDT).|3-4 weeks after the last PDT, up to 16 weeks after the first treatment|ITT|||percentage of change from baseline||Standard Deviation|Mean
2552121|NCT02799069|Secondary|Change From Baseline in Total Lesion Area 12 Weeks After Second Photodynamic Therapy (PDT)|the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 12 weeks after the second PDT. A second PDT was applied in case of non- or partially responding lesions 12 weeks after first PDT.|12 weeks after the second PDT, 24 after first treatment|ITT|||percentage of change from baseline||Standard Deviation|Mean
2552122|NCT02799069|Secondary|Change From Baseline in Total Lesion Area 3-4 Weeks After the Second Photodynamic Therapy (PDT)|the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 3-4 weeks after the second PDT. A second PDT was applied in case of non or partially responding lesions 12 weeks after first PDT.|3-4 weeks after the second PDT, 15-16 weeks after first treatment|ITT|||percentage of change from baseline||Standard Deviation|Mean
2552123|NCT02799069|Secondary|Change From Baseline in Total Lesion Area 12 Weeks After the First Photodynamic Therapy (PDT)|the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 12 weeks after the first PDT.|12 weeks after the first PDT|ITT|||percentage of change from baseline||Standard Deviation|Mean
2552124|NCT02799069|Secondary|Change From Baseline in Total Lesion Area 3-4 Weeks After the First Photodynamic Therapy (PDT)|Percentage of change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 3-4 weeks after the first PDT.|3-4 weeks after the first PDT|ITT|||percentage of change from baseline||Standard Deviation|Mean
2552125|NCT02799069|Secondary|Complete Lesion Response Rates 12 Weeks After Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only|"Completely cleared individual lesions 12 weeks after last PDT comprising of individual cleared lesions 12 weeks after the first or second PDT. A second PDT was applied in case individual lesion showed no or partial response 12 weeks after the first PDT.~Lesions were illuminated during photodynamic therapy with narrow spectrum devices only (~630 nm)."|up to 12 weeks after the last PDT, up to 24 weeks after first treatment|ITT|||percentage of lesions|lesions treated with narrow spectrum|95% Confidence Interval|Number
2552126|NCT02799069|Secondary|Complete Lesion Response Rate 12 Weeks After Last Photodynamic Therapy (PDT)|Completely cleared individual lesions 12 weeks after last PDT comprising of completely cleared individual lesions 12 weeks after the first or second PDT (a second PDT was applied in case individual lesions show no or partial response 12 weeks after first PDT).|12 weeks after the last PDT, up to 24 weeks after first treatment|ITT|||percentage of lesions|num,ber of individual lesions|95% Confidence Interval|Number
2552127|NCT02799069|Secondary|Complete Lesion Response Rate 3-4 Weeks After Last Photodynamic Therapy (PDT)|Completely cleared individual lesions defined at 3-4 weeks after the last PDT comprising of completely cleared individual lesions 3-4 weeks after the first and after the second PDT (a second PDT was applied in case lesions show no or partial response 12 weeks after the first PDT).|3-4 weeks after the last PDT, up to 16 weeks after first treatment|ITT|||percentage of lesions|number of individual lesions|95% Confidence Interval|Number
2552128|NCT02799069|Secondary|Complete Lesion Response Rate 12 Weeks After Second PDT|Completely cleared individual lesions as defined at 12 weeks after second PDT. A second PDT was applied in case the individual lesion showed no or partial response 12 weeks after first PDT.|12 weeks after the second PDT, 24 weeks after first treatment|ITT|||percentage of lesions|number of individual lesions|95% Confidence Interval|Number
2552129|NCT02799069|Secondary|Complete Lesion Response Rate 3-4 Weeks After the Second Photodynamic Therapy (PDT)|Completely cleared individual lesions as defined at 3-4 weeks after the second PDT. A second PDT was applied in case the individual lesion showed no or partial response12 weeks after first PDT.|3-4 weeks after the second PDT, 15-16 weeks after first treatment|ITT|||percentage of lesions|number of individiual lesions|95% Confidence Interval|Number
2552130|NCT02799069|Secondary|Complete Lesion Response Rate 12 Weeks After First Photodynamic Therapy (PDT)|Completely cleared individual lesions as defined at 12 weeks after the first photodynamic therapy (PDT).|12 weeks after the first PDT|ITT|||percentage of lesions|number of individual lesions|95% Confidence Interval|Number
2553265|NCT02780622|Secondary|Oral Plasma Clearance (CL/F) for Oseltamivir||Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.|||liters per hour (L/h)||Standard Deviation|Mean
2552132|NCT02799069|Secondary|Percentage of Participants With Partial Response at 12 Weeks After Last Photodynamic Therapy (PDT)|"A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after last PDT.~The outcome measure combined partial responders with at least 75% of lesions cleared at 12 weeks after the first PDT and after the second PDT (a second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT) ."|12 weeks after the last PDT, up to 24 weeks after first treatment|ITT|||percentage of patients||95% Confidence Interval|Number
2552133|NCT02799069|Secondary|Percentage of Participants With Partial Response at 3-4 Weeks After Last Photodynamic Therapy (PDT)|"A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after last PDT.~The outcome measure combined partial responders with at least 75% of lesions cleared at 3-4 weeks after the first PDT or after the second PDT (a second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT)."|3-4 weeks after the last PDT, up to 16 weeks after the first treatment|ITT|||percentage of patients||95% Confidence Interval|Number
2552134|NCT02799069|Secondary|Percentage of Participants With Partial Response at 12 Weeks After the Second Photodynamic Therapy (PDT)|"A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after the second PDT.~A second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT."|12 weeks after the second PDT, 24 weeks after first treatment|ITT|||percentage of patients||95% Confidence Interval|Number
2552135|NCT02799069|Secondary|Percentage of Participants With Partial Response at 3-4 Weeks After the Second Photodynamic Therapy (PDT)|"A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after the second PDT.~A second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT."|3-4 weeks after the second PDT, 15-16 weeks after first treatment|ITT|||percentage of patients||95% Confidence Interval|Number
2552136|NCT02799069|Secondary|Percentage of Participants With Partial Response at 12 Weeks After the First Photodynamic Therapy (PDT)|A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after the first PDT.|12 weeks after the first PDT|ITT|||percentage of patients||95% Confidence Interval|Number
2552137|NCT02799069|Secondary|Percentage of Participants With Partial Response at 3-4 Weeks After First Photodynamic Therapy (PDT)|A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after the first PDT.|3-4 weeks after the first PDT|ITT|||percentage of patients||95% Confidence Interval|Number
2552138|NCT02799069|Secondary|Percentage of Participants With Complete Response 3-4 Weeks After Last Photodynamic Therapy (PDT)|A complete responder at week 3-4 after treatment was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission). This outcome measure considered patients who were completely cleared at 3-4 weeks after the last PDT which included complete responders 3-4 weeks after the first and complete responders 3-4 weeks after the second PDT ( a second PDT was applied in case of remaining lesions 12 weeks after the first PDT).|3-4 weeks after the last PDT, up to 16 weeks after the first treatment|ITT|||percentage of patients||95% Confidence Interval|Number
2552139|NCT02799069|Secondary|Percentage of Participants With Complete Response 12 Weeks After Second Photodynamic Therapy (PDT)|A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 12 weeks after the second PDT. A second PDT was applied in case partial- or non-responding lesions remained 12 weeks after the first PDT.|12 weeks after the second PDT, 24 weeks after first treatment|ITT|||percentage of patients||95% Confidence Interval|Number
2552140|NCT02799069|Secondary|Percentage of Participants With Complete Response 3-4 Weeks After the Second Photodynamic Therapy (PDT)|A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 3-4 weeks after the second PDT. A second PDT was applied in case partial- or non-responding lesions remained 12 weeks after the first PDT.|3-4 weeks after the second PDT, 15-16 weeks after first treatment|ITT|||percentage of patients||95% Confidence Interval|Number
2552141|NCT02799069|Secondary|Percentage of Participants With Complete Response 12 Weeks After First Photodynamic Therapy (PDT)|A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 12 weeks after the first PDT.|12 weeks after the first PDT|ITT|||percentage of patients||95% Confidence Interval|Number
2552142|NCT02799069|Secondary|Percentage of Participants With Complete Response 3-4 Weeks After First Photodynamic Therapy (PDT)|A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 3-4 weeks after the first PDT.|3-4 weeks after the first PDT|ITT|||percentage of patients||95% Confidence Interval|Number
2552143|NCT02799069|Primary|Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only|"Subgroup analysis of patients treated with a narrow spectrum device for PDT Illumination (~630 nm).~An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT.~The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)"|12 weeks after the last PDT, up to 24 weeks after the first treatment|ITT|||percentage of patients||95% Confidence Interval|Number
2552144|NCT02799069|Primary|Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), PP|"An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT.~The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)"|12 weeks after the last PDT, up to 24 weeks after the first treatment|per protocol set (PP)|||percentage of patients||95% Confidence Interval|Number
2552145|NCT02799069|Primary|Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), ITT|"An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT.~The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)"|12 weeks after the last PDT, up to 24 weeks after the first treatment|Intent-to-treat (ITT)|||percentage of patients||95% Confidence Interval|Number
2552146|NCT02798978|Secondary|Change From Baseline in Pulse Rate for Part 2|Pulse rate was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Baseline and up to Day 7|All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552147|NCT02798978|Secondary|Change From Baseline in Respiratory Rate for Part 2|Respiratory rate was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Baseline and up to Day 7|All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552148|NCT02798978|Secondary|Change From Baseline in SBP and DBP for Part 2|SBP and DBP was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Baseline and up to Day 7|All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552149|NCT02798978|Secondary|Change From Baseline in Body Temperature for Part 2|Body temperature was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Baseline and up to Day 7|All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552150|NCT02798978|Secondary|Change From Baseline in CRP for Part 2|CRP assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Baseline and Pre-dose, 1, 2, 4, 8, 12, 16, 24, and 48 hours post dose|All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552151|NCT02798978|Secondary|Number of Participants With Clinical Chemistry Parameters Outside Reference Range in Part 2|Clinical chemistry as part of safety assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Up to Day 7|All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552152|NCT02798978|Secondary|Number of Participants With Hematology Parameters Outside Reference Range in Part 2|Hematology as part of safety assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Up to Day 7|All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552153|NCT02798978|Secondary|Number of Participants With Urinalysis Parameters Outside Reference Range for Part 2|Urinalysis as part of safety assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Up to Day 7|All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552154|NCT02798978|Secondary|Change From Baseline in WBC Differential for Part 2|WBC differential assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Baseline, 2, 24 and 144 hours|All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552155|NCT02798978|Secondary|Percentage Fold Change of Concentration of IL-10 From Baseline for Part 2|IL-10 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours|PD Population. The data was not collected for Part 2 because no Par. were enrolled into this part of the study.||||||
2552156|NCT02798978|Secondary|Percentage Fold Change of Concentration of IL-1Ra From Baseline for Part 2|IL-1Ra assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours|PD Population. The data was not collected for Part 2 because no Par. were enrolled into this part of the study.||||||
2552157|NCT02798978|Secondary|Percentage Fold Change of Concentration of GCSF From Baseline for Part 2|GCSF assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours|PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552158|NCT02798978|Secondary|Percentage Fold Change of Concentration of MCP-1 From Baseline for Part 2|MCP-1 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours|PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552159|NCT02798978|Secondary|Percentage Fold Change of Concentration of IP-10 From Baseline for Part 2|IP-10 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours|PD Population. The data was not collected for Part 2 because no Par. were enrolled into this part of the study.||||||
2552160|NCT02798978|Secondary|Percentage Fold Change of Concentration of IFN-gamma From Baseline for Part 2|IFN-gamma assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours|PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552161|NCT02798978|Secondary|Percentage Fold Change of Concentration of TNF-alpha From Baseline for Part 2|TNF-alpha assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours|PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552162|NCT02798978|Secondary|Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 2|IL-6 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours|PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552163|NCT02798978|Secondary|Time Invariance of GSK1795091 for Part 2|Time invariance assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose|PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552164|NCT02798978|Secondary|Accumulation Ratio of GSK1795091 for Part 2|Accumulation ratio assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose|PK Parameter Population. Data were not collected for part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552165|NCT02798978|Secondary|Volume of Distribution of GSK1795091 for Part 2|Volume of distribution assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose|PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552166|NCT02798978|Secondary|Clearance (CL) of GSK1795091 for Part 2|CL assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose|PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552167|NCT02798978|Secondary|Area Under the Concentration-time Curve (AUC) Time Curve for a Dosing Interval (AUC[0-tau]), AUC (0-last) of GSK1795091 for Part 2|AUC (0-tau) and AUC (0-last) assessments were planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose|PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552204|NCT02798952|Secondary|Number of Subjects With Anti-HBs Concentrations Above the Cut-off.|The cut-off of the assay was ≥ 100 mIU/mL.|At Day 0 and Day 30|The analysis was based on the According-to-Protocol cohort for analyses of immunogenicity, which included all subjects who met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom post-vaccination immunogenicity results were available.|||Participants|||Count of Participants
2552168|NCT02798978|Secondary|Partial Area Under the Concentration-time Curve to Time = t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 2|AUC (0-t) and AUC (0-inf) assessments were planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose|PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552169|NCT02798978|Secondary|Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 2|Tmax and t1/2 assessments were planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.|Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose|PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552170|NCT02798978|Secondary|Maximum Observed Drug Concentration (Cmax) of GSK1795091 for Part 2|Cmax assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of Adverse events (AEs) of unknown etiology.|Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose|PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.||||||
2552171|NCT02798978|Secondary|Change From Baseline in CRP for Part 1|Blood samples were collected at indicated time points for the assessment of CRP. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value.|Baseline, Days 2, 4 and 7|All Subjects Population|||mg/L||Standard Deviation|Mean
2552172|NCT02798978|Secondary|Change From Baseline in WBC Differential for Part 1|WBC differential included Lymphocytes Count, Monocytes Count, Granulocytes Count including neutrophils and eosinophil. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).|Baseline, 4, 24 and 144 hours|All Subjects Population|||10^9 cells per liter||Standard Deviation|Mean
2552173|NCT02798978|Secondary|Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1|Blood samples were collected at indicated time points for the assessment of IL-10. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100*change from Baseline divided by Baseline.|Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours|PD Population|||Percent fold change||Standard Deviation|Mean
2552174|NCT02798978|Secondary|Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1|Blood samples were collected at indicated time points for the assessment of IL-1Ra. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100*change from Baseline divided by Baseline.|Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours|PD Population|||Percent fold change||Standard Deviation|Mean
2552175|NCT02798978|Secondary|Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1|Blood samples were collected at indicated time points for the assessment of GCSF. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100*change from Baseline divided by Baseline.|Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours|PD Population|||Percent fold change||Standard Deviation|Mean
2552176|NCT02798978|Secondary|Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1|Blood samples were collected at indicated time points for the assessment of MCP-1. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100*change from Baseline divided by Baseline.|Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours|PD Population|||Percent fold change||Standard Deviation|Mean
2552177|NCT02798978|Secondary|Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1|Blood samples were collected at indicated time points for the assessment of IP-10. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100*change from Baseline divided by Baseline.|Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours|PD Population|||Percent fold change||Standard Deviation|Mean
2552178|NCT02798978|Secondary|Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1|Blood samples were collected at indicated time points for the assessment of IFN-gamma. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100*change from Baseline divided by Baseline. Data from multiplex immunoassay has been reported. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).|Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours|PD Population|||Percent fold change||Standard Deviation|Mean
2552179|NCT02798978|Secondary|Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1|Blood samples were collected at indicated time points for the assessment of TNF-alpha. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100*change from Baseline divided by Baseline. Data from multiplex immunoassay has been reported. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).|Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours|PD Population.|||Percent fold change||Standard Deviation|Mean
2552180|NCT02798978|Secondary|Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1|"Blood samples were collected at indicated time points for the assessment of IL-6. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100*change from Baseline divided by Baseline. All participants in the All Subjects Population for whom valid and evaluable pharmacodynamic parameters were derived are included in Pharmacodynamic (PD) Population. Data from multiplex immunoassay has been reported."|Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours|PD Population.|||Percent fold change||Standard Deviation|Mean
2552181|NCT02798978|Secondary|Volume of Distribution of GSK1795091 for Part 1|Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. Only those participants with data available at the specified data points were analyzed.|Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose|PK Parameter Population. NA indicates data was not available as all concentration outcomes at 7ng were not quantifiable because all results were below the limit of quantification.|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
2552182|NCT02798978|Secondary|Clearance (CL) of GSK1795091 for Part 1|Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. Only those participants with data available at the specified data points were analyzed.|Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose|PK Parameter Population. NA indicates data was not available as all concentration outcomes at 7ng were not quantifiable because all results were below the limit of quantification.|||Liters per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2552183|NCT02798978|Secondary|Partial Area Under the Concentration-time Curve to Time t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 1|Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. AUC (0-t) was used interchangeably with AUC to last time of quantifiable concentration (AUC[0-last]) .Only those participants with data available at the specified data points were analyzed.|Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose|PK Parameter Population. NA indicates data was not available as all concentration outcomes at 7ng were not quantifiable because all results were below the limit of quantification.|||Hours*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2552184|NCT02798978|Secondary|Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 1|Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. Only those participants with data available at the specified data points were analyzed.|Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose|PK Parameter Population. NA indicates data was not available for 7 ng Arm as all concentration outcomes at 7 ng were not quantifiable because all results were below the limit of quantification.|||Hours||Standard Deviation|Mean
2552185|NCT02798978|Secondary|Maximum Observed Drug Concentration (Cmax) of GSK1795091 for Part 1|Blood samples were collected at indicated time points. The Pharmacokinetic (PK) parameters were calculated for each participant using a non-compartmental method. All participants for whom, at least, one valid and evaluable pharmacokinetic parameter (AUC or Cmax) was derived were included in PK Parameter Population. Only those participants with data available at the specified data points were analyzed.|Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose|PK Parameter Population. NA indicates data was not available for 7 ng Arm as all concentration outcomes at 7 ng were not quantifiable because all results were below the limit of quantification.|||Picogram/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2552186|NCT02798978|Primary|Number of Participants With Abnormal Electrocardiograms (ECG) Findings Worst Case Post-Baseline|Single measurements of 12-lead ECGs were obtained after 10 minutes of rest in a semi-supine position for the participant. Participants with abnormal ECG findings that are clinically not significant (NCS) and clinically significant (CS) data has been presented here. The data of worst case post-Baseline is presented here.|Up to Day 32|All Subjects Population.|||Participants|||Count of Participants
2552187|NCT02798978|Primary|Urine Potential of Hydrogen (pH) at Indicated Time Points|Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7|All Subject Population|||pH||Standard Deviation|Mean
2552188|NCT02798978|Primary|Specific Gravity at Indicated Time Points|Urinalysis included parameter like specific gravity. Urinary specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine.|Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7|All Subjects Population|||Ratio||Standard Deviation|Mean
2552189|NCT02798978|Primary|Urine Protein at Indicated Time Points|Urinalysis included parameter like Urine protein. Data at indicated time points were reported.|Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7|All Subjects Population|||Gram per liter||Standard Deviation|Mean
2552190|NCT02798978|Primary|Occult Blood at Indicated Time Points|Urinalysis included parameter like Occult blood. Data at indicated time points were reported.|Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7|All Subjects Population|||10^9 cells per liter||Standard Deviation|Mean
2552191|NCT02798978|Primary|Ketones and Urine Glucose at Indicated Time Points|Urinalysis included parameters like ketones and urine glucose. Data at indicated time points were reported.|Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7|All Subjects Population|||Millimoles per liter||Standard Deviation|Mean
2552192|NCT02798978|Primary|Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points|Urinalysis included microscopic examination parameters like Casts, REC, SEC, Urine erythrocytes and Urine leukocytes. Data at indicated time points were reported. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point.|Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7|All Subjects Population|||Cells per high power field||Standard Deviation|Mean
2552193|NCT02798978|Primary|Number of Participants With Clinical Chemistry Parameters Outside Reference Range|Clinical chemistry parameters with reference range were albumin 35-52*g/L, Alkaline phosphatase (ALP) 30-120*International units/L (IU/L), Alanine aminotransferase (ALT) 0-50 * IU/L, Aspartate aminotransferase (AST) 0-50*IU/L, direct bilirubin 0-3.4* micromoles/L (µmol/L), bilirubin 5-21*µmol/L, calcium 2.2-2.65* millimoles/L (mmol/L), cholesterol 0-5.19* mmol/L, creatinine 59-104* µmol/L, C-reactive protein (CRP) 0-5*milligram (mg)/L,Gamma Glutamyl Transferase (GGT) 4.1-5.9*mmol/L, high density lipoproteins (HDL) cholesterol 0.99-2.32*mmol/L, potassium 3.5-5.1*mmol/L, low density lipoproteins (LDL) cholesterol 0-3.3*mmol/L, protein 66-83*g/L, sodium 136-146 * mmol/L, triglycerides 0-2.25 * mmol/L, glucose 4.1-5.9*mmol/L, and urea 2.8-7.2*mmol/L. Values below these ranges were considered as low and above these ranges were considered as high. Data for participants from any visit post-screening with values > reference range high and < reference range low are reported.|Up to Day 7|All Subjects Population.|||Participants|||Count of Participants
2552194|NCT02798978|Primary|Number of Participants With Hematology Parameters Outside Reference Range Part 1|Hematology parameters included hemoglobin (HGB), hematocrit (HCT), Red Blood Cell (RBC) count, White Blood Cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), platelet count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). Reference range for basophil was 0.01 - 0.07*10^9/Liters (L), eosinophils 0.03 - 0.5*10^9/L, HCT 0.38 - 0.48 proportion of RBC in blood, HGB 126 - 165*gram (g)/L, lymphocytes 1.08 - 3*10^9/L, MCH 26.3 - 32.8*picogram (pg), MCHC 324 - 359*g/L, MCV 77 - 94.9*femtoliter (fL), monocytes 0.3 - 0.92*10^9/L, neutrophils 1.46 - 5.85*10^9/L, platelets 155 - 342*10^9/L, erythrocytes 4.12 - 5.74*10^12/L, leukocytes 3.19 - 8.71*10^9/L. Values below these ranges were considered as low and above these ranges were considered as high (H). Data for participants from any visit post-screening with values > reference range high and < reference range low are report.|Up to Day 7|All Subjects Population.|||Participants|||Count of Participants
2552195|NCT02798978|Primary|Change From Baseline in Respiratory Rate Part 1|Respiratory rate was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value.|Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7.|All Subjects Population.|||Breaths per minute||Standard Deviation|Mean
2552196|NCT02798978|Primary|Change From Baseline in Pulse Rate Part 1|Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value.|Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7.|All Subjects Population.|||Beats per minute||Standard Deviation|Mean
2552197|NCT02798978|Primary|Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1|Systolic and diastolic BP was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value.|Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7.|All Subjects Population.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2552198|NCT02798978|Primary|Change From Baseline in Body Temperature Part 1|Body temperature was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value.|Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7.|All Subjects Population.|||Celsius||Standard Deviation|Mean
2552199|NCT02798978|Primary|Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or events associated with liver injury and impaired liver function were categorized as SAE. All participants enrolled into the study who have received a dose of study medication (GSK1795091 or placebo) were included in the All Subjects Population. Participants with non-serious AEs (5 percentage threshold) and SAEs has been reported.|Up to Day 32|All Subjects Population.|||Participants|||Count of Participants
2552200|NCT02798952|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|An SAE was defined as any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to Day 30|The analysis was based on the Total Vaccinated cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
2552201|NCT02798952|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Within 31 days (Day 0 - Day 30) after the vaccination.|The analysis was based on the Total Vaccinated cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
2552202|NCT02798952|Secondary|Number of Subjects With Any Solicited Local and General Symptoms.|Solicited local symptoms assessed were pain, redness and swelling at injection site. Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (defined as axillary temperature ≥ 37.5°C).|Within 4 days (Day 0 - Day 3) after the vaccination|The analysis was based on the Total Vaccinated cohort, which included all subjects who received the study vaccine and had their symptoms sheet completed .|||Participants|||Count of Participants
2552203|NCT02798952|Secondary|Number of Subjects With an Anamnestic Response to the Hepatitis B Challenge Dose.|"Anamnestic response was defined as:~For initially seronegative subjects: antibody concentration ≥10mIU/mL. For initially seropositive subjects: antibody concentration at least four times the pre-challenge antibody concentration."|At Day 30|The analysis was based on the According-to-Protocol cohort for analyses of immunogenicity, which included all subjects who met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom post-vaccination immunogenicity results were available.|||Participants|||Count of Participants
2552205|NCT02798952|Secondary|Number of Seroprotected Subjects for Anti-HBs.|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations equal to or above 10 milli-International units per milliliter (mIU/ml).|At Day 0 and day 30|The analysis was based on the According-to-Protocol cohort for analyses of immunogenicity, which included all subjects who met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom post-vaccination immunogenicity results were available.|||Participants|||Count of Participants
2552206|NCT02798952|Secondary|Number of Seropositive Subjects for Anti-HBs.|A seropositve subject was defined as a subject with anti-HBs antibody concentrations above the assay cut-off (≥ 6.2 mIU/ml).|At Day 0 and Day 30|The analysis was based on the According-to-Protocol cohort for analyses of immunogenicity, which included all subjects who met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom post-vaccination immunogenicity results were available.|||Participants|||Count of Participants
2552207|NCT02798952|Secondary|Anti-HBs Antibody Concentrations|Concentrations were expressed in geometric mean concentrations (GMCs).|At Day 0|The analysis was based on the According-to-Protocol cohort for analyses of immunogenicity, which included all subjects who met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom post-vaccination immunogenicity results were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2552208|NCT02798952|Primary|Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations|Concentrations were expressed in geometric mean concentrations (GMCs).|At Day 30.|The analysis was based on the According-to-Protocol cohort for analyses of immunogenicity, which included all subjects who met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom post-vaccination immunogenicity results were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2552209|NCT02798380|Primary|Treatment Related Adverse Events|Frequency and severity of Treatment Related Adverse Events|Up to 48 weeks|Safety Population: All Enrolled|||Participants|||Count of Participants
2552210|NCT02798354|Other Pre-specified|Percent of Clinics Reaching Predetermined Threshold for Adolescents Screened for Depression With Patient Health Questionnaire-9 Modified (PHQ-9M) During Well Child Visits|Clinics reported percent of adolescent well child visit charts with depression screening done each month. They reported whether this percentage was equal to or greater than 90%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months.|Collected monthly for 8 months when practice is intervening on this topic||||Clinics|Clinics||Count of Units
2552211|NCT02798354|Other Pre-specified|Percent of Clinics Reaching Pre-determined Threshold for Children Greater Than or Equal to 3 Yrs Old Receiving Blood Pressure Measurements at Triage for Well Child Visits|Clinics reported percent of well child visit charts with blood pressure measurements at triage done each month. They reported whether this percentage was equal to or greater than 90%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months.|Collected until 2 months||||Clinics|Clinics||Count of Units
2552212|NCT02798354|Other Pre-specified|Percent of Clinics Reaching Pre-Determined Threshold for Providers With Laboratory Results Unread/Unacknowledged in Their Electronic Health Record (EHR) Inbox for More Than 72 Hrs|Clinics reported percent of EHR inboxes with laboratory results unread/unacknowledged in their electronic health record (EHR) inbox for more than 72 hrs each month. They reported whether this percentage was equal to or less than 10%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months.|Collected at 4 months||||Clinics|Clinics||Count of Units
2552213|NCT02798354|Secondary|Number of Patients With Abnormal Laboratory Results Received and Recognized by Provider|Provider documentation of abnormal laboratory value, of appropriate diagnosis (e.g. iron deficiency anemia) or appropriate action taken without delay as defined above.|Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)||||Participants|||Count of Participants
2552214|NCT02798354|Secondary|Number of Patients With Elevated Blood Pressures Measured and Recognized by Provider|Systolic or Diastolic Blood Pressure >= 90th percentile for age, gender and height or >=120/80 in >=3 years old patients at well child visits with provider documentation of abnormal blood pressure or appropriate action taken|Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)||||Participants|||Count of Participants
2552215|NCT02798354|Secondary|Number of Patients With Elevated Blood Pressures Measured and Blood Pressure Percentiles Documented in the Chart|Systolic or Diastolic Blood Pressure >= 90th percentile for age, gender and height or >=120/80 in >=3 years old patients at well child visits with blood pressure percentiles documented per the 4th Report.|Collected Monthly (5-0 baseline months and 8-9 intervention months depending on the enrolled cohort)||||Participants|||Count of Participants
2552216|NCT02798354|Secondary|Number of Adolescents With Mental Health Addressed During Their Well Child Visit|Provider screened for mental health concerns either with standard screening tool or clinical judgement and documented mental health concerns or no mental health concerns.|Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)||||Participants|||Count of Participants
2552217|NCT02798354|Primary|Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay|"Documented action step for first positive within 30 days:~Hemoglobin (Hgb) less than 11 and mean corpuscular volume (MCV) less than 75 in 1 or 2 year old without documentation of beginning iron, sending iron studies or family conversation~Lead greater than 5 without documentation of family conversation on lead remediation or plan to retest~Documented action step for first positive within 7 days:~Positive Gonorrhea, Chlamydia, Syphilis or Human immunodeficiency virus (HIV) test without documentation of antibiotics begun or referral to HIV specialist~Positive group A streptococcal throat culture with negative rapid group A streptococcal test without documentation of antibiotics begun or family conversation~Thyroid stimulating hormone (TSH) less than 0.5 or greater than 4.5 in greater than 1 year old without plan to repeat lab values or referral to endocrinologist"|Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)||||Participants|||Count of Participants
2552242|NCT02797522|Primary|Pharmacokinetics of ARC-521 Injection: Terminal Elimination Half-Life (t1/2), Healthy Volunteers||Through 48 hours post-dose on Day 1|Analysis was not planned or conducted per SAP due to study termination.||||||
2552218|NCT02798354|Primary|Number of Patients With Elevated Blood Pressure Measured and Appropriately Acted on by Providers|Systolic or Diastolic Blood Pressure >= 90th percentile for age, gender and height or >=120/80 in >=3 years old patients at well child visits and at least one of: 1) provider repeated blood pressure, 2) clinic note mentions elevated blood pressure/hypertension 3) plan included recheck or evaluation of blood pressure, or 4) ordering laboratory or other studies to evaluate elevated blood pressure|Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)||||Participants|||Count of Participants
2552219|NCT02798354|Primary|Number of Adolescents Diagnosed With Depression Seen in Well Child Visits|Patients >=11 years old with documentation of major depression or subsyndromal depression diagnoses in the medical record|Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)||||Participants|||Count of Participants
2552220|NCT02798315|Secondary|Patient Support Program (PSP) Questionnaire: Utilization of PSP Components|Percentage of participants using each component of the PSP, including personal support, educational and information material (printed, online) and additional digital and mobile resources (web-portal, app, and reminders).|Up to EoT, maximum of 24 weeks|Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) and who participated int he PSP.|||Participants|||Count of Participants
2552221|NCT02798315|Secondary|Change From Baseline in the PAM-13 Questionnaire|"The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Each of the 13 items can be answered with one of four possible response options, which are disagree strongly (1), disagree (2), agree (3), agree strongly (4). Based on responses to the 13-item measure, the score is calculated by adding up the raw scores (range of the sum: 13 - 52) and mapping up the value onto a scale of 0-100 indicating strength of agreement with the 13 items. A higher score indicates that the patient is likely to participate more actively in health care processes and takes more responsibility for his or her health."|Up to 48 weeks|Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) and contributed to the PAM-13.|||units on a scale||Inter-Quartile Range|Median
2552222|NCT02798315|Secondary|Adherence: Percentage of Planned Duration of RBV Taken by Participant||Up to 48 weeks|Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) and were prescribed RBV.|||percentage of planned duration of RBV||Standard Deviation|Mean
2552223|NCT02798315|Secondary|Adherence to RBV: Percentage of RBV Dose Taken in Relation to the Target Dose of RBV|Percentage of the RBV dose taken in relation to the target dose of RBV (cumulative dose taken divided by target dose in percent), presented as the number of participants taking > 95% to ≤ 105% of the target dose and those taking > 80% to ≤ 95% of the target dose.|Up to 48 weeks|Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype) and were prescribed RBV.|||Participants|||Count of Participants
2552224|NCT02798315|Secondary|Adherence to ABBVIE Regimen: Percentage of the Direct-acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA|Percentage of the DAA dose taken in relation to the target dose of DAA (cumulative dose taken divided by target dose in percent), presented as the number of participants taking > 95% to ≤ 105% of the target dose and those taking > 80% to ≤ 95% of the target dose.|Up to 48 weeks|Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||Participants|||Count of Participants
2552225|NCT02798315|Secondary|Percentage of Participants Meeting the SVR Non-response Categories of Premature Study Drug Discontinuation or Missing SVR12 Data and/or None of the Above Criteria|Premature study drug discontinuation category is defined as participants who prematurely discontinued study drug and who experienced no on-treatment virologic failure. The final SVR non-response category was defined as missing SVR12 data and/or none of the above criteria.|12 weeks (i.e. at least 70 days) after the last dose of study drug|Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants|||Number
2552226|NCT02798315|Secondary|Percentage of Participants Meeting the SVR Non-response Categories of On-treatment Virologic Failure or Relapse|On-treatment virologic failure defined as breakthrough (at least 1 documented HCV RNA less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL). Relapse (defined as HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≥50 IU/mL post-treatment).|12 weeks (i.e. at least 70 days) after the last dose of study drug|Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants|||Number
2552227|NCT02798315|Secondary|Percentage of Participants With Breakthrough.|Breakthrough defined as at least 1 documented HCV RNA less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment.|Up to EoT, maximum of 24 weeks|Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants|||Number
2552228|NCT02798315|Secondary|Percentage of Participants With Relapse at EoT|Relapse defined as HCV RNA less than 50 IU/mL at EoT followed by HCV RNA greater than or equal to 50 IU/mL.|Up to EoT, maximum of 24 weeks|Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants|||Number
2552229|NCT02798315|Secondary|Percentage of Participants With Virological Response at End of Treatment (EoT)|Virological response defined as HCV RNA level less than 50 IU/mL.|Up to EoT, maximum of 24 weeks|Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants||95% Confidence Interval|Number
2552230|NCT02798315|Primary|Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)|SVR12 defined as the HCV ribonucleic acid (RNA) level less than 50 IU/mL 12 weeks after the last dose of study drug|12 weeks (i.e. at least 70 days) after the last dose of study drug|Core population: all participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants||95% Confidence Interval|Number
2552231|NCT02798289|Primary|Tear Meniscus Height Captured by Optical Coherence Tomography|Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography.|Day 1|Safety population included all subjects who received device intervention.|||µm||Standard Deviation|Mean
2552232|NCT02797821|Secondary|Change In Plasma PLP From Baseline To Pre-3rd Dose At Week 9|Plasma PLP was quantified using liquid chromatography/mass spectrometry. Baseline plasma PLP values were calculated by averaging the pre-dose PLP values from blood samples collected during the Run-in Period at -168, -156, -24, -12, and 0 hours before Baseline. Week 9 PLP values were calculated using blood samples collected before the administration of the 3rd dose. The analysis was a REML-based repeated measures mixed model with treatment, visit, sex, Baseline PPi, Baseline weight group (≥ median versus < median) and study drug lot assignment as factors, and an unstructured covariance structure for within-participant correlation.|Baseline to Week 9|FAS: randomized participants who received ≥1 dose of study drug and had ≥1 pretreatment and ≥1 on-treatment PPi result.|||ng/mL||Standard Error|Least Squares Mean
2552233|NCT02797821|Primary|Change In Plasma PPi From Baseline To Pre-3rd Dose At Week 9|"Plasma PPi concentrations were determined using a specific enzyme-catalyzed reaction with a radiolabelled marker in a 3-step process. Baseline plasma PPi values were calculated by averaging pre-dose values from samples collected during the Run-in Period at -168, -156, -24, -12, and 0 hours before Baseline. Week 9 plasma PPi values were calculated using blood samples collected before administration of the 3rd dose. The analysis was a restricted maximum likelihood (REML)-based repeated measures mixed model with treatment, visit, sex, Baseline PPi, Baseline weight group (≥ median versus < median), and study drug lot assignment as factors, and an unstructured covariance structure for within-participant correlation.~Per inclusion criteria, participants had to have had a Screening PPi concentration of ≥3.9 micromolar (μM). Three participants (1 in each group) had Screening PPi concentrations of ≥3.9 μM, but Baseline PPi values ranged between 3.5 to 3.8 μM."|Baseline to Week 9|FAS: randomized participants who received ≥1 dose of study drug and had ≥1 pretreatment and ≥1 on-treatment PPi result.|||μM||Standard Error|Least Squares Mean
2552234|NCT02797678|Primary|Amount of Cumulative Slow Wave Activity Detected by the Powersleep Device With and Without Stimulation|"For the analysis of SWA, six-second-long NREM epochs were considered. Every 30 s-long window was subdivided into five epochs and the sleep stage of the window was assigned to every epoch.~In our research, both SWA and CSWA are evaluated as relative values having as reference the average SWA and CSWA over sham sleep sessions. CSWA is the integral of SWA which is why the unit of CSWA is microvolt^2×minute."|10 nights|"7 completed participants were excluded from the final analysis for the following reasons: 3 - non-scorable data - signal interference 3 - did not cross over~1 - did not meet inclusion/exclusion criteria"|||microvolts^2x minute||Standard Deviation|Mean
2552235|NCT02797678|Secondary|Changes in Memory Scores as Measured by the Paired-Associate-Learning (PAL)|Participants performed a learning activity of an 80 word pair list the night of the in-lab visit and then completed a recall in the morning following the overnight in the sleep lab. The results listed below are the mean and standard deviation of the PowerSleep treatment week compared to the Sham treatment week.|2 nights|Only 22 participants completed the PAL the morning after the overnight in the sleep lab. 6 participants did not complete the PAL on both nights.|||words||Standard Deviation|Mean
2552236|NCT02797678|Secondary|Changes in Vigilance Scores as Measured by the Psychomotor Vigilance Task (PVT)|"To measure trends of vigilance of one work week (4 nights of home use and one night in the sleep lab) with active PowerSleep (delivering audio tones) as compared to a one work week (4 nights of home use and one night in the sleep lab) of sham (delivering no audio tones).~The measure of vigilance scored was average reaction time in milliseconds."|10 nights|"7 completed participants were excluded from the final analysis for the following reasons: 3 - non-scorable data - signal interference 3 - did not cross over~1 - did not meet inclusion/exclusion criteria"|||milliseconds||Standard Deviation|Mean
2552237|NCT02797678|Primary|Amount of Slow Wave Activity Detected by the Powersleep Device With and Without Stimulation|"Slow wave activity levels will be compared analyzed by using the PowerSleep Device with stimulation and without stimulation (sham).~For the analysis of SWA, six-second-long NREM epochs were considered. Every 30 s-long window was subdivided into five epochs and the sleep stage of the window was assigned to every epoch.~The SWA of each epoch was estimated from the epoch's power spectrum density (PSD) by integrating over the frequency range spanning from 0.5 to 4 Hz.~The PSD per epoch was estimated according to the Welch method with a four- second long Hanning window (ensuring 0.25 Hz frequency resolution), a two-second-long overlap, and 1024 points to calculate the Fourier transform.~Since μ-arousal events have spike-like temporal characteristics that manifest as high values in the spectral domain, epochs containing annotated-arousals were discarded from SWA analysis. The average SWA was calculated by taking the average slow-wave activity over all considered NREM epochs"|10 nights|"7 completed participants were excluded from the final analysis for the following reasons: 3 - non-scorable data - signal interference 3 - did not cross over~1 - did not meet inclusion/exclusion criteria"|||microvolts^2||Standard Deviation|Mean
2552238|NCT02797613|Primary|The Number of Patients Receiving Appropriate Treatment|Sum of urinary tract infection treated and asymptomatic bacteriuria not treated|72 hours from positive culture|Intention to treat|||Participants|||Count of Participants
2552239|NCT02797522|Secondary|Change Over Time in Complement Levels After Single and Multiple Doses of ARC-521 Injection||Through 24 hours post-dose (Day 1 for NHVs, and Days 1, 29 & 57 for CHB participants)|Analysis was not planned or conducted per SAP due to study termination.||||||
2552240|NCT02797522|Secondary|Change Over Time in Cytokine Levels After Single and Multiple Doses of ARC-521 Injection||Through 24 hours post-dose (Day 1 for NHVs, and Days 1, 29 & 57 for CHB participants)|Analysis was not planned or conducted per SAP due to study termination.||||||
2552241|NCT02797522|Primary|Change Over Time in Viral Antigens and DNA in CHB Participants as a Measure of Activity of ARC-521 Injection||Baseline to Day 142|Analysis was not planned or conducted per SAP due to study termination.||||||
2552250|NCT02797522|Primary|Number of Participants With TEAEs: CHB Participants|An AE is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious AE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.Events were categorized as mild, moderate or severe. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product. A treatment-related TEAE was one whose relationship to treatment was noted as unlikely, possibly, or probably related.|From first dose of study drug through Day 142 (± 3 days)||||Participants|||Count of Participants
2552251|NCT02797522|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs): Healthy Volunteers|An adverse event (AE) is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious AE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.Events were categorized as mild, moderate or severe. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product. A treatment-related TEAE was one whose relationship to treatment was noted as unlikely, possibly, or probably related.|From first dose of study drug through Day 29 (± 1 day)||||Participants|||Count of Participants
2552252|NCT02797132|Secondary|Part B: Pre-dose Concentration (Ctrough) of LUM and IVA and Its Metabolites||Week 24|"The PK set for Part B included all participants who received at least 1 dose of LUM/IVA in Part B. Here Number Analyzed signifies those participants who were evaluable for the specified category."|||ng/mL||Standard Deviation|Mean
2552253|NCT02797132|Secondary|Part B: Absolute Change From Baseline in Lung Clearance Index (LCI) 5.0 at Week 24|LCI is a measure of ventilation inhomogeneity that is derived from a multiple breath washout test using Nitrogen (N2). LCI 5.0 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/20th of its starting value.|Baseline, Week 24|"The LCI Substudy Set included all subjects who had signed informed consent (and assent, if applicable) to the optional LCI Substudy in Part B and enrolled and dosed in Part B. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||ratio||Standard Deviation|Mean
2552254|NCT02797132|Secondary|Part B: Absolute Change From Baseline in Lung Clearance Index (LCI) 2.5 at Week 24|Lung clearance index (LCI) is a measure of ventilation inhomogeneity that is derived from a multiple breath washout test using Nitrogen (N2). LCI 2.5 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting value.|Baseline, Week 24|"The LCI Substudy Set included all participants who had signed informed consent (and assent, if applicable) to the optional LCI Substudy in Part B and enrolled and dosed in Part B. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||ratio||Standard Deviation|Mean
2552255|NCT02797132|Secondary|Part B: Acceptability/Palatability of LUM/IVA Granules Measured Using Hedonic Scale|The acceptability and palatability of LUM/IVA granules was assessed by a visual analog scale that incorporates a 5 point facial hedonic scale (Liked it Very Much, Liked it a Little, Not sure, Disliked it a Little, Disliked it Very Much). The assessment was conducted in 2 steps: assessment of approved food/liquid (Evaluation 1), and assessment of approved food/liquid with LUM/IVA granules (Evaluation 2).|Day 1|"The FAS included all enrolled subjects in Part B who were exposed to any amount of LUM/IVA in Part B. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||Participants|||Count of Participants
2552256|NCT02797132|Secondary|Part B: Absolute Change in Sweat Chloride From Week 24 at Week 26|Sweat samples were collected using an approved collection device.|Week 24, Week 26|"The FAS included all enrolled subjects in Part B who were exposed to any amount of LUM/IVA in Part B. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||mmol/L||Standard Deviation|Mean
2552257|NCT02797132|Secondary|Part B: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Week 24|"Analysis population: participants >=3 years of age with data available for Baseline and Week 24. Only participants from Part B (>=14 Kg Weight) arm met the eligibility criteria for the specified time point and were included in the analysis."|||percentage of predicted FEV1||Standard Deviation|Mean
2552258|NCT02797132|Secondary|Part B: Number of Participants With Microbiology Culture Status (Positive or Negative) at Week 24|Following microbial tests were performed: Burkholderia, Methicillin Resistant Staphylococcus Aureus (MRSA), Methicillin Susceptible Staphylococcus Aureus (MSSA), Pseudomonas Aeruginosa Mucoid (P. Aeruginosa Mucoid), P. Aeruginosa Non-Mucoid, P. Aeruginosa Small Colony Variant and Stenotrophomonas Maltophilia.|Baseline and Week 24|"The FAS analysis set was used. Here Number Analyzed signifies those participants who were evaluated for this outcome at the specified time point.."|||Participants|||Count of Participants
2552259|NCT02797132|Secondary|Part B: Absolute Change From Baseline in Serum Levels of Immunoreactive Trypsinogen (IRT) Through Week 24||Baseline, Through Week 24|"The FAS included all enrolled participants in Part B who were exposed to any amount of LUM/IVA in Part B. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||ng/mL||Standard Deviation|Mean
2552260|NCT02797132|Secondary|Part B: Absolute Change From Baseline in Fecal Elastase-1 (FE-1) Levels at Week 24||Baseline, Week 24|"The FAS included all enrolled subjects in Part B who were exposed to any amount of LUM/IVA in Part B. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||microgram per gram||Standard Deviation|Mean
2552261|NCT02797132|Secondary|Part B: Number of Cystic Fibrosis (CF)-Related Hospitalizations||Through Week 24|The FAS included all enrolled participants in Part B who were exposed to any amount of LUM/IVA in Part B.|||hospitalizations|||Number
2552285|NCT02796963|Secondary|Number of Men Reporting Using Mobile Apps in the Past Three Months Post-intervention to Give or Receive Information About HIV Testing|Frequency of men, defined as the number of men who reported using mobile apps in the past three months to give or receive information about HIV testing comparing their pre-intervention and post-intervention engagement|From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
2552262|NCT02797132|Secondary|Part B: Number of Participants With at Least One Pulmonary Exacerbation Pulmonary Exacerbation Through Week 24|Pulmonary exacerbation was defined as new or changed treatment with oral, inhaled, or intravenous antibiotics and fulfillment of pre-specified protocol defined criteria. Time to event data was not collected and instead, number of participants with first event were collected and are reported. Time-to-first pulmonary exacerbation was planned to be estimated using Kaplan-Meier (KM) estimates. However, due to less than 50% of events, time-to-first event data was not estimated. Instead, number of participants with at least one pulmonary exacerbation event were collected and are reported.|Through Week 24|The FAS included all enrolled participants in Part B who were exposed to any amount of LUM/IVA in Part B.|||Participants|||Count of Participants
2552263|NCT02797132|Secondary|Part B: Number of Pulmonary Exacerbations|Pulmonary exacerbation was defined as new or changed treatment with oral, inhaled, or intravenous antibiotics and fulfillment of pre-specified protocol defined criteria.|Through Week 24|"The FAS included all enrolled participants in Part B who were exposed to any amount of LUM/IVA in Part B. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||pulmonary exacerbations|||Number
2552264|NCT02797132|Secondary|Part B: Absolute Change From Baseline in Stature-for-Age Z-Score|z-score is a statistical measure to describe whether a mean was above or below the standard. Stature (height), adjusted for age and sex, was analyzed as Stature-for-age z-score (Stature z-score).|Baseline, Week 24|"The FAS included all enrolled participants in Part B who were exposed to any amount of LUM/IVA in Part B. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||Z-score||Standard Deviation|Mean
2552265|NCT02797132|Secondary|Part B: Absolute Change From Baseline in Stature (Height) at Week 24||Baseline, Week 24|"The FAS included all enrolled participants in Part B who were exposed to any amount of LUM/IVA in Part B. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||Centimeter (cm)||Standard Deviation|Mean
2552266|NCT02797132|Secondary|Part B: Absolute Change From Baseline in Weight-for-age Z-Score at Week 24|z-score is a statistical measure to describe whether a mean was above or below the standard. Weight, adjusted for age and sex, was analyzed as weight-for-age z-score (Weight z-score).|Baseline, Week 24|"The FAS included all enrolled subjects in Part B who were exposed to any amount of LUM/IVA in Part B. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||Z-score||Standard Deviation|Mean
2552267|NCT02797132|Secondary|Part B: Absolute Change From Baseline in Weight at Week 24||Baseline, Week 24|"The FAS included all enrolled participants in Part B who were exposed to any amount of LUM/IVA in Part B. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||Kilogram (kg)||Standard Deviation|Mean
2552268|NCT02797132|Secondary|Part B: Absolute Change From Baseline in Body Mass Index (BMI) For-Age Z-Score at Week 24|BMI was defined as weight in kg divided by height in m^2. z-score is a statistical measure to describe whether a mean was above or below the standard. BMI, adjusted for age and sex, was analyzed as BMI-for-age z-score (BMI z-score).|Baseline, Week 24|"The FAS included all enrolled participants in Part B who were exposed to any amount of LUM/IVA in Part B. Here Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome."|||Z-score||Standard Deviation|Mean
2552269|NCT02797132|Secondary|Part B: Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilograms (kg) divided by height in square meter (m^2).|Baseline, Week 24|"The FAS included all enrolled participants in Part B who were exposed to any amount of LUM/IVA in Part B. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||Kilogram per meter square (kg/m^2)||Standard Deviation|Mean
2552270|NCT02797132|Secondary|Part B: Absolute Change From Baseline in Sweat Chloride at Week 24|Sweat samples were collected using an approved collection device.|Baseline, Week 24|"The Full Analysis Set (FAS) included all enrolled participants in Part B who were exposed to any amount of LUM/IVA in Part B. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome."|||millimole per liter (mmol/L)||Standard Deviation|Mean
2552271|NCT02797132|Secondary|Part A: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)||Day 1 up to Day 25|The Safety Set included all participants who received at least 1 dose of LUM/IVA in Part A.|||Participants|||Count of Participants
2552272|NCT02797132|Secondary|Part A: Pre-dose Concentration (Ctrough) of LUM and IVA Metabolites||Day 15|The PK set for Part A included all participants who received at least 1 dose of LUM/IVA in Part A.|||ng/mL||Standard Deviation|Mean
2552273|NCT02797132|Primary|Part B: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)||Day 1 up to Week 26|The Safety Set included all participants who received at least 1 dose of LUM/IVA in Part B.|||Participants|||Count of Participants
2552274|NCT02797132|Primary|Part A: Pre-dose Concentration (Ctrough) of LUM and IVA||Day 15|The pharmacokinetic (PK) set for Part A included all participants who received at least 1 dose of LUM/IVA in Part A.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2552275|NCT02797080|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs|An adverse event (AE) is any untoward medical occurrence, whether or not the event is considered related to the investigational product. A TEAE is any adverse change from the subject's baseline condition, including any laboratory test value abnormality judged as clinically significant by the investigator, that occurs on or after the date of the first dose of study drug administered at home and throughout the duration of the clinical study, whether the adverse event is considered related to the treatment or not. A serious AE (SAE) is an AE that results in death, is life-threatening, results in persistent or significant disability or incapacity, inpatient hospitalization or prolongation of an existing hospitalization, is a congenital anomaly or birth defect, or other medically important event.|Baseline/Day 1 (Week 28 Follow-Up Visit for Study HZNP-ACT-302 ([NCT02593773]) through end of study; mean (SD) duration of treatment was 99.2 (58.48) days.|Safety Population, defined as all participants who received at least 1 dose of study drug after the Baseline Visit for Study HZNP-ACT-303.|||participants|||Number
2552276|NCT02797054|Primary|Percent of Participants Who Agreed They Felt They Had Enough Support to Make a Decision About Getting the HPV Vaccine at Follow-up||2 Months||||Percent of participants|||Number
2552290|NCT02796963|Secondary|Mean Score of Anticipated HIV Stigma|Measured by a 7-item version of the anticipated HIV stigma scale, designed to measure the extent to which participants anticipated negative intrapersonal and interpersonal consequences were they to contract HIV in the future. All seven items were rated on a Likert-type scale (1=Strongly Disagree; 4=Strongly Agree). The mean score is reported, ranged from 1 to 4. Higher values indicate greater anticipated stigma.|From implementation roll-out to three months after implementation of crowdsourced intervention||||Scores on a scale||Standard Deviation|Mean
2552291|NCT02796963|Secondary|Number of Men Reporting Being Self-tested for HIV in the Last 3 Months Post-intervention||From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
2552292|NCT02796963|Secondary|Number of Men Reporting Engaged in HIV Testing Community Campaign in the Past 3 Months||From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
2552293|NCT02796963|Secondary|Community Engagement/ MSM Community Affiliation|Number of men, defined as an increase in closer affiliation with the MSM community (i.e., tongzhi circle, gay online networks or groups) when comparing their pre-intervention and post-intervention periods.|From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
2552294|NCT02796963|Secondary|Change in HIV Testing Self-efficacy|Number of men who report higher levels of self-efficacy when comparing their pre-intervention and post-intervention HIV testing norms|From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
2552295|NCT02796963|Secondary|HIV Testing Social Norms|HIV testing social norms will be measured using six survey items that are each on a five-point Likert scale. Increased HIV testing social norms will be defined as having an increase from baseline in any two of these six survey items and dichotomized accordingly. Number of men who report higher score of social norms when comparing their pre-intervention and post-intervention values|From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
2552296|NCT02796963|Secondary|Number of Men Reporting Condomless Sex at 3 Months Post-intervention||From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
2552297|NCT02796963|Primary|Number of Men Who Have Sex With Men (MSM) Reporting HIV Testing in the Past Three Months|This will be assessed by self-report during a follow-up survey|From implementation roll-out to three months after implementation of crowdsourced intervention||||Participants|||Count of Participants
2552298|NCT02796677|Secondary|Responder (Number of Participants) Analysis of St. George's Respiratory Questionnaire (SGRQ) Total Score With AB/FF 400/12 μg Versus AB 400 μg and FF 12 μg.|"SGRQ was a A standardized self-completed tool used to measure impaired health and perceived well-being (quality of life) in respiratory diseases. The questionnaire contained 50 items divided into 3 (symptoms, activity and impacts) dimensions. Each of the three dimensions of the questionnaire is scored separately in the range from 0 to 100%, zero score indicating no impairment of life quality. A summary score utilizing responses to all items is the total SGRQ score which also ranges from 0 to 100%. The SGRQ scores are calculated using weights attached to each item of the questionnaire which provides an estimate of the distress associated with the symptoms or state described in each item. Higher scores indicate poorer health. A decrease of at least 4 units in the SGRQ total score has been established as the criterion for minimal meaningful improvement. SGRQ responders will be those with a decrease in SGRQ total score of at least 4 units from baseline."|At baseline and Week 24|ITT population: All randomized participants who took at least one dose of IP and had at least a baseline FEV1, under the ITT principle and regardless the adherence to the randomized treatment.|||Participants|||Count of Participants
2552299|NCT02796677|Secondary|Change From Baseline in Normalized Area Under Curve 3hours Post-dose (nAUC0-3/3h) FEV1 of AB/FF 400/12 μg Compared to AB 400 μg and and FF 12 μg at Week 24|To assess the bronchodilatory effect by evaluating the mean changes from baseline in nAUC0-3/3h FEV1 of AB/FF 400/12 µg compared to AB 400 μg and and FF 12 μg after administration of oral inhalation powder BID via DPI to participants with COPD.|At Day 1 and Day 169|ITT population: All randomized participants who took at least one dose of IP and had at least a baseline FEV1, under the ITT principle and regardless the adherence to the randomized treatment.|||Litres||Standard Error|Least Squares Mean
2552300|NCT02796677|Primary|Change From Baseline in Morning Predose (Trough) FEV1 at Week 24 Comparing AB 400 μg Versus TIO 18 μg to Demonstrate Non-inferiority|To assess the non-inferior bronchodilatory effect by evaluating the mean changes from baseline in FEV1 in morning pre-dose (trough)of AB 400 µg compared to TIO 18 μg after administration of oral inhalation powder BID via DPI to participants with COPD.|At baseline morning predose and Week 24|Per-Protocol (PP) population: A subset of the ITT population, consisted of participants who met all inclusion/exclusion criteria liable to affect the efficacy assessment, had sufficient treatment compliance, and did not present serious deviations of the protocol that might affect efficacy.|||Litres||Standard Error|Least Squares Mean
2552301|NCT02796677|Primary|Change From Baseline in Morning Predose (Trough) FEV1 of AB/FF 400/12 μg Compared to FF 12 μg at Week 24|"To assess the bronchodilatory effect by evaluating the mean changes from baseline in FEV1 in morning pre-dose (trough) of AB/FF 400/12 µg compared to FF 12 μg after administration of oral inhalation powder BID via DPI to participants with COPD.~Morning pre-dose (trough) FEV1 was defined as the average of the corresponding -30 minute and 0 minute before the morning study medication at Week 24. If one time-point was missing then the available one would be used as morning pre-dose."|At baseline morning predose and Week 24|ITT population: All randomized participants who took at least one dose of IP and had at least a baseline FEV1, under the ITT principle and regardless the adherence to the randomized treatment.|||Litres||Standard Error|Least Squares Mean
2552315|NCT02796274|Primary|In Eyes With VA Assessment Made ≤1 Year After Onset of Symptoms: Proportion of Eyes With Clinically Relevant Recovery (CRR) of VA (Measured by Change in ETDRS Letters) From Baseline (BL) or in Which BL VA Better Than 1.0 logMAR Was Maintained at 12 Months|Clinically Relevant Recovery (CRR) is defined as a VA improvement from off-chart (ETDRS) to 5 letters on-chart, or an on-chart improvement of 10 letters.|12 months|Data from a total of 219 LHON patients and 438 eyes were obtained from this study, out of which 96 eyes had a VA assessment made ≤1 year after the onset of symptoms (primary outcome measure).|||ETDRS letters|eyes|Inter-Quartile Range|Median
2552302|NCT02796677|Primary|Change From Baseline in 1-hour Morning Post-dose Dose Forced Expiratory Volume in 1 Second (FEV1) of AB/FF 400/12 μg Compared to AB 400 μg at Week 24|"To assess the bronchodilatory effect by evaluating the mean changes from baseline in FEV1 at 1 hour post-dose of AB/FF 400/12 µg compared to AB 400 μg after administration of oral inhalation powder BID via DIP to participants with COPD.~Baseline was defined as the average of the two FEV1 values measured just prior to the administration of the first dose of investigational product (IP) at randomization Visit. If one of the two was missing, then the available one would be used as baseline value."|At baseline 1-hour postdose and Week 24|Intention-to Treat (ITT) population: All randomized participants who took at least one dose of IP and had at least a baseline FEV1, under the ITT principle and regardless the adherence to the randomized treatment.|||Litres||Standard Error|Least Squares Mean
2552303|NCT02796651|Secondary|Change From Baseline in Morning Pre-dose (Trough) FEV1 at Day 7 on Treatment|"To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg). Trough value was defined as the mean of the 2 pre-dose measurements on Day 7. If 1 of the 2 measurements was missing, the non-missing measurement was used as the trough value.~Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation."|At baseline and Day 7|The ITT analysis set consisted of all randomized participants who received at least 1 dose of investigational product (IP) and had a baseline FEV1 value and at least 1 post-baseline FEV1 measurement, regardless of a participant’s adherence to the randomized treatment.|||Litre||95% Confidence Interval|Least Squares Mean
2552304|NCT02796651|Secondary|Change From Baseline in FEV1 AUC0-6/6h at Day 7 on Treatment|To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg). 6-hour serial spirometry was performed at Day 7 of each treatment period: spirometry was performed post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 6 hours post-dose Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation|Day 7: zero time to 6 hours post-dose|The ITT analysis set consisted of all randomized participants who received at least 1 dose of investigational product (IP) and had a baseline FEV1 value and at least 1 post-baseline FEV1 measurement, regardless of a participant’s adherence to the randomized treatment.|||Litre/Hour||95% Confidence Interval|Least Squares Mean
2552305|NCT02796651|Secondary|Change From Baseline in FEV1 AUC0-6/6h at Day 1 on Treatment|To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate (20 μg and 40 μg). 6-hour serial spirometry was performed at Day 1 of each treatment period: spirometry was performed post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 6 hours post-dose.|Day 1: zero time to 6 hours post-dose|The ITT analysis set consisted of all randomized participants who received at least 1 dose of investigational product (IP) and had a baseline FEV1 value and at least 1 post-baseline FEV1 measurement, regardless of a participant’s adherence to the randomized treatment.|||Litre/Hour||95% Confidence Interval|Least Squares Mean
2552306|NCT02796651|Primary|Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Over the 12 h Period Immediately After Morning Study Drug Administration, AUC0-12/12h at Day 7 on Treatment|"To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate(20 μg).~Pre-dose spirometry was performed before the morning daily dose at Day 1 and Day 7 of each treatment period. Two sets of measurements were performed during the hour preceding the scheduled morning study drug administration, allowing approximately 30 minutes between them.~Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation."|Day 7: 30 min, 1 to 4 hours, 6 hours, 9 hours and 12 hours post-dose|The ITT analysis set consisted of all randomized participants who received at least 1 dose of investigational product (IP) and had a baseline FEV1 value and at least 1 post-baseline FEV1 measurement, regardless of a participant’s adherence to the randomized treatment.|||Litre/Hour||95% Confidence Interval|Least Squares Mean
2552307|NCT02796352|Secondary|HD IL2 Levels|Levels of HD IL2 biomarker in the blood of patients that received at least course 1 of therapy, and have had their disease re-evaluated will be considered evaluable for response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) version 1.1|Up to 21 months|No data displayed because data were not collected for this Outcome Measure, thus zero total participants analyzed.||||||
2552308|NCT02796352|Secondary|Overall Survival (OS)|Number of months from start of protocol therapy until death from any cause.|Up to 15 months for accrual, plus 6 months of intervention for last subject enrolled, plus 5 years of follow-up (6 years, 9 months)||||months|||Number
2552309|NCT02796352|Secondary|Progression Free Survival (PFS)|Number of months of survival without disease progression from start of protocol therapy until objective tumor progression or death, per RECIST v1.1|Up to 15 months for accrual, plus 6 months of intervention for last subject enrolled, plus 5 years of follow-up (6 years, 9 months)||||months|||Number
2552310|NCT02796352|Primary|Response Rate|Percentage of complete responses (CR) plus partial responses (PR), based upon Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1|Up to 15 months for accrual, plus 6 months of intervention for last subject enrolled (21 months)||||Participants|||Count of Participants
2552311|NCT02796300|Secondary|Cost Analysis|To perform a cost-analysis and economic burden of using Bioflo catheters compared to Palindrome catheters due to catheter thrombosis and exchange.|3 months|Two patients in the Palindrome group were not included in this outcome measure analysis. One patient received the kidney transplant during the 3 month follow-up and the second patient died during the 3 month follow-up|||US Dollar||Standard Error|Mean
2552312|NCT02796300|Secondary|Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.|If necessary, we will monitor the catheter thrombosis rate of Bioflo catheters vs. Palindrome catheters.|6 months|||||||
2552313|NCT02796300|Secondary|Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.|A comparison of the number of tPA used as an indicator of thrombosed catheter per month between two groups in three month follow-up|3 months|Two patients in the Palindrome group were not included in this outcome measure analysis. One patient received the kidney transplant during the 3 month follow-up and the second patient died during the 3 month follow-up|||catheter thrombosis per 3 months||Standard Error|Mean
2552325|NCT02796092|Secondary|Satisfaction With the Procedure|"Overall satisfaction with the procedure via telephone survey (scaled from 0 to 9).~Patients answered just one question. Are you satisfied with the procedure? Being 0 = Completely unsatisfied, I regret having undergone a embolization procedure 9=Totally satisfied with the procedure, everything was perfect, I would recommend it to anyone with the same problem."|12 months||||units on a scale||Standard Deviation|Mean
2552326|NCT02796092|Secondary|Improvement of Dysmenorrhea|Disappearance or improvement of dysmenorrhea assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)|12 months|Population presenting pre-treatment dysmenorrhea|||participants|||Number
2552327|NCT02796092|Secondary|Improvement of Urinary Urgency|Disappearance or improvement of urinary urgency assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)|12 months|Population presenting pre-treatment urinary urgency|||participants|||Number
2552328|NCT02796092|Secondary|Improvement of Dyspareunia|Disappearance or improvement of dyspareunia assessed by direct questioning before the procedure and 12 months after the procedure (YES/NO)|12 months|Population presenting pre-treatment dyspareunia|||participants|||Number
2552329|NCT02796092|Primary|Change in Pain Scale|"Reduction of 4 points or more between subjective pain assessed by VAS prior to procedure (-4, -5,- 6, -7,-8,-9).~VAS= visual analogue scale: it is a subjective pain scale, scored from 1 to 10 (1 no pain; 10 worst pain possible)"|12 months|Population presenting pre-treatment pain (more than 1 in VAS)|||participants|||Number
2552330|NCT02795832|Other Pre-specified|ZPL-5212372 Trough Plasma Concentrations in Cohort 3|PK parameters for patients who had ointment applied over 40% BSA.|Day 5, Day 8, Day 10, Day 15|Pharmacokinetic analysis set|||pg/mL||Full Range|Median
2552331|NCT02795832|Other Pre-specified|ZPL-5212372 AUCt for Patients in Cohort 2|PK parameters for patients who had ointment applied over 40% BSA.|Day 1, Day 7|Pharmacokinetic analysis set|||h*pg/mL||Full Range|Median
2552332|NCT02795832|Other Pre-specified|ZPL-5212372 Cmax for Patients in Cohort 2|PK parameters for patients who had ointment applied over 40% BSA.|Day 1, Day 7|Pharmacokinetic analysis set|||pg/mL||Full Range|Median
2552333|NCT02795832|Secondary|Change From Baseline in Body Surface Area at Week 2 - Observed Case in Cohort 3|Body Surface Area (BSA). The percentage BSA affected was summarised at each visit, including change from baseline, by treatment group, using the Full Analysis Set.|Day 1 to day 14|Full analysis set|||score on a scale||Standard Error|Least Squares Mean
2552334|NCT02795832|Secondary|Summary of Patient Global Impression of Change and Logistic Regression of Patient Global Impression of Change in Cohort 3|"Patient Global Impression of Change (PGIC) The PGIC scores were summarised for the FAS with counts and percentages in each treatment group. All data collected were included.~The PGIC was dichotomized into responders, defined as responses of 'Very Much Improved', 'Much Improved' or 'Minimally improved' and non-responders (all other responses plus missing data)."|End of treatment (day 15)|Full analysis set|||Participants|||Count of Participants
2552335|NCT02795832|Secondary|Change From Baseline in NRS for Pruritus at Week 2 - Observed Case in Cohort 3|"Numerical Rating Scale (NRS) for Pruritus (worst itch). The Pruritus NRS is an assessment tool that will be used to assess the subject's worst itch as a result of AD in the previous 24 hours.~They will be asked the following question:~On a scale of 0 (No Itching) to 10 (Itching as bad as you can imagine), please rate the WORST itching that you felt over the last 24 hours."|Day 1 to day 14|Full analysis set|||score on a scale||Standard Error|Least Squares Mean
2552336|NCT02795832|Secondary|Percentage of Responders on Investigators Global Assessment in Cohort 3|"The following secondary endpoints were assessed for IGA:~A subject was considered as having IGA success if they achieved a score of 'Clear' or 'Almost clear'; note, as subjects required a score of ≥3 to enter the study they must have had a reduction of ≥2 from baseline to achieve success A subject was considered as having an IGA response if they achieved a score of 'Clear' or 'Almost clear', or a reduction of ≥2 from baseline IGA was summarized for the FAS with counts and percentages by treatment at each visit."|Day 14|Full analysis set|||Percentage of responders||95% Confidence Interval|Number
2552337|NCT02795832|Secondary|Summary of EASI-50 and EASI-75 Responders at Week 2 - Cohort 3|"The proportion of subjects who achieved EASI-50 and EASI-75 responses at Week 2 were compared between treatment groups.~EASI-50 was defined as a ≥50% reduction from baseline in EASI score at Week 2. EASI-75 was defined as a ≥75% reduction from baseline in EASI score at Week 2."|Day 14|Full analysis set|||participants|||Number
2552338|NCT02795832|Primary|Percent Change From Baseline in EASI Score Over Time in Cohort 3 - Observed Case|The EASI is a validated tool used to measure the severity and extent of atopic eczema (Eczema Area and Severity Index). The body is divided into 4 sections of total skin area: head including neck (10%); arms including extremities (20%); trunk (30%) and legs including extremities (40%). Each area is scored and the 4 scores are combined into the final EASI. The severity parameters are measured on a scale of 0 to 3 (from none to severe). For each section, the percentage area of skin involved with eczema is estimated and transformed into an extent grade from 0 to 6, from 0% of involved skin area with eczema to 90-100% of involved skin area with eczema. The sum of all four severity parameters is calculated for each section of skin and then multiplied by the weight of the respective section. This value is then multiplied by the extent score for that body area. The EASI value can range from 0-72, a higher score indicates more severe disease.|Days 1, 5, 8, 10, and 15|Full Analysis set|||percent change from baseline in EASI||Standard Error|Mean
2552339|NCT02795832|Primary|Percent Change From Baseline in EASI Score in Cohort 3|The EASI is a validated tool used to measure the severity and extent of atopic eczema (Eczema Area and Severity Index). The body is divided into 4 sections of total skin area: head including neck (10%); arms including extremities (20%); trunk (30%) and legs including extremities (40%). Each area is scored and the 4 scores are combined into the final EASI. The severity parameters are measured on a scale of 0 to 3 (from none to severe). For each section, the percentage area of skin involved with eczema is estimated and transformed into an extent grade from 0 to 6, from 0% of involved skin area with eczema to 90-100% of involved skin area with eczema. The sum of all four severity parameters is calculated for each section of skin and then multiplied by the weight of the respective section. This value is then multiplied by the extent score for that body area. The EASI value can range from 0-72, a higher score indicates more severe disease.|Day 1 and Day 14|Full Analysis set|||percent change from baseline in EASI||Standard Error|Mean
2553266|NCT02780622|Secondary|Terminal Half-life (t½) for R- and S- Warfarin||Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.|||hours||Standard Deviation|Mean
2552340|NCT02795819|Secondary|The Antitumor Effects of the AR-42 and Pazopanib Treatment Regimen in Patients With Advanced Renal Cell Carcinoma (RCC) or Soft Tissue Sarcoma (STS).|"Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI:~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|5 months|Of 6 patients treated at dose level 1, 4 were evaluable for response.|||Participants|||Count of Participants
2552341|NCT02795819|Secondary|Number of Participants With Adverse Events That Were Related to Treatment, AR-42 and Pazopanib Combination.|The safety and toxicity of AR-42 and pazopanib when given in combination. Adverse Events (AEs) were characterized and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0) to determine the safety and toxicity of the combination of AR-42 and pazopanib. All AEs regardless of grade were recorded from the beginning of the study procedures through 30 days following the end of study treatment.|5 months||||Participants|||Count of Participants
2552342|NCT02795819|Primary|The Recommended Phase 2 Doses (RP2Ds) of AR-42 and Pazopanib When Given in Combination.|To determine the recommended phase 2 doses (RP2Ds) for AR-42 and pazopanib that are the same as or less than the maximum tolerated doses (MTDs). The dose-limiting toxicity (DLT) evaluation period will be the first treatment cycle. Patients must have taken a minimum of 6 AR-42 doses and a minimum of 21 pazopanib doses during cycle 1 to be considered evaluable for DLT, if DLT has not been observed at the delivered dose. Patients' treatment dose level, dose modification, evaluability for DLT, and DLTs will be listed and summarized by basic descriptive statistics such as frequency and proportion. The maximum tolerated dose(MTDs)/recommended phase 2 doses (RP2Ds) will be found based on the criteria in the protocol.|1 month|Incomplete objective. No maximum tolerated dose (MTD) nor recommended phase two dose (RP2D) identified. Two dose limiting toxicities observed in 6 patients treated at the first dose level. Study terminated prior to exploration of additional dose levels.|||Dose Limiting Toxicities|Dose Limiting Toxicities||Count of Units
2552343|NCT02795767|Secondary|Plasma Trough Concentration (Ctrough) of Emicizumab|Pre-dose (trough) plasma concentrations of emicizumab were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantitation was 0.1 micrograms per milliliter (μg/mL).|Predose (0 hour) at Weeks 1, 2, 3, 4, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 49, and 57; then every 12 weeks until end of study or 24 weeks after treatment discontinuation (up to approximately 152 weeks)|Participants who received at least one dose of emicizumab and had at least one post-dose emicizumab plasma concentration result available|||micrograms per milliliter (μg/mL)||Standard Deviation|Mean
2552344|NCT02795767|Secondary|Number of Participants Testing Negative or Positive for the Presence of Anti-Drug Antibodies (ADA), Including Non-Neutralizing ADA and ADA With Neutralizing Potential|'Total ADA Negative' is the sum of all participants who tested negative for ADA in the 2 following categories: 'ADA Negative', those who are pre-dose ADA negative or are missing pre-dose ADA data and who have all negative post-dose ADA results; and 'ADA Negative (Treatment Unaffected)', a subset who are pre-dose ADA positive but do not have a ≥4-fold increase in post-dose ADA levels compared to baseline measurement. 'Total ADA Positive' is the sum of all participants who tested positive for ADA in the 2 following categories: 'ADA Positive (Treatment Boosted)', those who are pre-dose ADA positive and have a ≥4-fold increase in post-dose ADA levels compared to baseline measurement; and 'ADA Positive (Treatment Induced)', those who are pre-dose ADA negative or missing data and who have at least one post-dose ADA positive sample. ADAs associated with consistent decline of emicizumab exposure (corroborated by associated loss of effect) were considered as having a neutralizing potential.|Predose (0 hour) at Weeks 1, 5, 17, 33, 49, 57; then every 12 weeks until end of study or 24 weeks after treatment discontinuation (up to approximately 152 weeks)|All participants who received at least one dose of emicizumab|||Participants|||Count of Participants
2552345|NCT02795767|Secondary|Number of Participants With at Least One Adverse Event of Thrombotic Microangiopathy||From Baseline up to 24 weeks after study drug discontinuation; At the primary completion date, the median (min-max) duration of observation in Cohorts A, B, and C were 57.36 (17.9-92.6), 21.29 (18.6-24.1), and 20.71 (18.0-24.1) weeks, respectively.|All participants who received at least one dose of emicizumab|||Participants|||Count of Participants
2552346|NCT02795767|Secondary|Number of Participants With at Least One Adverse Event of Thromboembolic Event||From Baseline up to 24 weeks after study drug discontinuation; At the primary completion date, the median (min-max) duration of observation in Cohorts A, B, and C were 57.36 (17.9-92.6), 21.29 (18.6-24.1), and 20.71 (18.0-24.1) weeks, respectively.|All participants who received at least one dose of emicizumab|||Participants|||Count of Participants
2552347|NCT02795767|Secondary|Number of Participants With at Least One Adverse Event of Systemic Hypersensitivity, Anaphylaxis, or Anaphylactoid Reaction|Systemic hypersensitivity, anaphylaxis, or anaphylactoid reactions were identified by the investigator using Sampson's criteria, as defined in the protocol. At the primary completion date, one participant had reported two non-serious adverse events (cough and abdominal pain) that were identified as a potential case based on a Standardised MedDRA Queries (SMQ) search for Sampson's criteria. However, after medical review of the case, it was confirmed that this case was not indicative of a systemic hypersensitivity, anaphylaxis, or anaphylactoid reaction.|From Baseline up to 24 weeks after study drug discontinuation; At the primary completion date, the median (min-max) duration of observation in Cohorts A, B, and C were 57.36 (17.9-92.6), 21.29 (18.6-24.1), and 20.71 (18.0-24.1) weeks, respectively.|All participants who received at least one dose of emicizumab|||Participants|||Count of Participants
2552532|NCT02793154|Primary|Part A: Estimated Glomerular Filtration Rate at Indicated Time Points|"Estimated glomerular filtration rate was calculated using the modification of diet in renal disease (MDRD) formula by multiplying 175 with serum creatinine^-1.154 multiplied by age^-0.203 multiplied by 0.742 (if female) multiplied by 1.212 (if African American Par.). Individual Par. data at indicated time point has been presented."|Day 5|All Subjects Population|||Milliliter per second per 1.73 meter ^2|||Number
2552348|NCT02795767|Secondary|Number of Participants With at Least One Adverse Event of Local Injection Site Reaction|"Local adverse events that occurred within 24 hours after study drug administration and, in the investigator's opinion, were judged to be related to study drug injection, were captured as an injection-site reaction on the Adverse Event electronic Case Report Form (eCRF). An injection-related reaction that was localized was marked as a local injection-site reaction."|From Baseline up to 24 weeks after study drug discontinuation; At the primary completion date, the median (min-max) duration of observation in Cohorts A, B, and C were 57.36 (17.9-92.6), 21.29 (18.6-24.1), and 20.71 (18.0-24.1) weeks, respectively.|All participants who received at least one dose of emicizumab|||Participants|||Count of Participants
2552349|NCT02795767|Secondary|Number of Participants With at Least One Adverse Event Leading to Withdrawal From Treatment||From Baseline up to 24 weeks after study drug discontinuation; At the primary completion date, the median (min-max) duration of observation in Cohorts A, B, and C were 57.36 (17.9-92.6), 21.29 (18.6-24.1), and 20.71 (18.0-24.1) weeks, respectively.|All participants who received at least one dose of emicizumab|||Participants|||Count of Participants
2552350|NCT02795767|Secondary|Number of Participants With at Least One Grade ≥3 Adverse Event|The World Health Organization (WHO) toxicity grading scale was used for assessing adverse event severity. For adverse events that are not specifically listed in the WHO toxicity grading scale, a grade 3 adverse event is defined as: severe, marked limitation in activity, some assistance usually required, medical intervention or therapy required, hospitalization possible; and a grade 4 adverse event is defined as: life-threatening, extreme limitation in activity, significant assistance required, significant medical intervention or therapy required, hospitalization or hospice care probable.|From Baseline up to 24 weeks after study drug discontinuation; At the primary completion date, the median (min-max) duration of observation in Cohorts A, B, and C were 57.36 (17.9-92.6), 21.29 (18.6-24.1), and 20.71 (18.0-24.1) weeks, respectively.|All participants who received at least one dose of emicizumab|||Participants|||Count of Participants
2552351|NCT02795767|Secondary|Number of Participants With at Least One Adverse Event|The number of participants experiencing at least one adverse event, including all non-serious and serious adverse events, are reported.|From Baseline up to 24 weeks after study drug discontinuation; At the primary completion date, the median (min-max) duration of observation in Cohorts A, B, and C were 57.36 (17.9-92.6), 21.29 (18.6-24.1), and 20.71 (18.0-24.1) weeks, respectively.|All participants who received at least one dose of emicizumab|||Participants|||Count of Participants
2552352|NCT02795767|Secondary|Change From Baseline Over Time in the Caregiver-Reported Adapted Inhib-QoL Questionnaire Physical Health Domain Score, Treated Participants <12 Years of Age|Proxy assessment of health-related quality of life (HRQoL) and aspects of caregiver burden were assessed using the Adapted Inhib-QoL questionnaire, which comprises two parts with a total of 30 questions. The first part asks the caregiver for his/her opinion on the child's HRQoL (proxy HRQoL) and consists of two scales: Physical Health and Treatment. The second part asks the caregiver to rate how the child's situation is for them (i.e., the impact of the child's disease and treatment on the caregiver) and consists of 6 scales (5 if the child does not have siblings): General Condition, Dealing with the Inhibitor, Perceive Treatment, Family Life, Siblings, Contact with Others. Items are rated with five respective response options: never, seldom, sometimes, often, and all the time. A total score is calculated as the sum of all of the items in the scale. The Physical Health domain score ranges from 0 to 100, with lower scores reflective of better physical health.|Baseline (Week 1), Weeks 13, 25, 37, 49, and 57, and then every 24 weeks until end of study (up to approximately 152 weeks)|All treated participants <12 years of age, as completed by their caregivers; at each timepoint, the number analyzed is the number of participants who completed a sufficient number of questionnaire items.|||units on a scale||95% Confidence Interval|Mean
2552353|NCT02795767|Secondary|Change From Baseline Over Time in Caregiver-Reported Adapted Health-Related Quality of Life for Hemophilia Patients With Inhibitors Including Aspects of Caregiver Burden (Adapted Inhib-QoL) Questionnaire Total Score, Treated Participants <12 Years of Age|Proxy assessment of health-related quality of life (HRQoL) and aspects of caregiver burden were assessed using the Adapted Inhib-QoL questionnaire, which comprises two parts with a total of 30 questions. The first part asks the caregiver for his/her opinion on the child's HRQoL and consists of two scales: Physical Health and Treatment. The second part asks the caregiver to rate how the child's situation is for them (i.e., the impact of the child's disease and treatment on the caregiver) and consists of 6 scales (5 if the child does not have siblings): General Condition, Dealing with the Inhibitor, Perceive Treatment, Family life, Siblings, Contact with Others. Items are rated with five respective response options: never, seldom, sometimes, often, and all the time. The Total Score is derived from the individual scores of all of the domains and it ranges from 0 to 100, with lower scores reflective of better HRQoL.|Baseline (Week 1), Weeks 13, 25, 37, 49, and 57, and then every 24 weeks until end of study (up to approximately 152 weeks)|All treated participants <12 years of age, as completed by their caregivers; at each timepoint, the number analyzed is the number of participants who completed a sufficient number of questionnaire items.|||units on a scale||95% Confidence Interval|Mean
2552354|NCT02795767|Secondary|Change From Baseline Over Time in the Haemo-QoL-SF Questionnaire Physical Health Domain Score, as Completed by Treated Participants ≥8 to <12 Years of Age|The Haemo-QoL-SF is a self-reported questionnaire for children ≥8 years of age. It contains 35 items, which cover nine domains considered relevant for the children's health-related quality of life: Physical Health, Feelings, View of Yourself, Family, Friends, Other People, Sports and School, Dealing with Hemophilia, and Treatment. The Physical Health domain assesses hemophilia-related symptoms (painful swellings and presence of joint pain) and physical functioning (pain with movement). Items are rated with five respective response options: never, seldom, sometimes, often, and always. The Physical Health domain score ranges from 0 to 100, with a lower score reflective of better physical health.|Baseline (Week 1), Weeks 13, 25, 37, 49, and 57, and then every 24 weeks until end of study (up to approximately 152 weeks)|All treated participants ≥8 to <12 years of age; at each timepoint, the number analyzed is the number of participants who completed a sufficient number of questionnaire items.|||units on a scale||95% Confidence Interval|Mean
2552533|NCT02793154|Primary|Part A: Creatinine, Direct Bilirubin, Total Bilirubin, Indirect Bilirubin Levels at Indicated Time Points|Blood samples were collected for analysis of clinical chemistry parameters including creatinine, direct bilirubin, total bilirubin, indirect bilirubin levels. Individual Par. data at indicated time points has been presented.|Day 5|All Subjects Population|||Micromoles per liter|||Number
2552355|NCT02795767|Secondary|Change From Baseline Over Time in the Hemophilia-Specific Quality of Life Short Form (Haemo-QoL-SF) Questionnaire Total Score, as Completed by Treated Participants ≥8 to <12 Years of Age|The Haemo-QoL-SF is a self-reported questionnaire for children ≥8 years of age. It contains 35 items, which cover nine domains considered relevant for the children's health-related quality of life: Physical Health, Feelings, View of Yourself, Family, Friends, Other People, Sports and School, Dealing with Hemophilia, and Treatment. Items are rated with five respective response options: never, seldom, sometimes, often, and always. The Total Score is derived from the scores for all domains and ranges from 0 to 100, with a lower score reflective of better health-related quality of life.|Baseline (Week 1), Weeks 13, 25, 37, 49, and 57, and then every 24 weeks until end of study (up to approximately 152 weeks)|All treated participants ≥8 to <12 years of age; at each timepoint, the number analyzed is the number of participants who completed a sufficient number of questionnaire items.|||units on a scale||95% Confidence Interval|Mean
2552356|NCT02795767|Secondary|Number of All Bleeds Over Time in Participants With Dose Up-Titration|"The number of all bleeds over time was to be analyzed in participants whose emicizumab maintenance dose was up-titrated to 3 mg/kg QW if they had experienced suboptimal bleeding control on emicizumab at steady-state, per protocol criteria. In this outcome measure, all bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded. As all bleeds comprises both treated and non-treated bleeds, the 72-hour rule was implemented separately for treated and non-treated bleeds. For treated bleeds, the 72-hour rule was implemented exactly as defined for the treated bleeds outcome measure. For non-treated bleeds, the 72-hour rule was implemented by calculating a treatment-free period of 72 hours from the bleed itself."|From Baseline to 52 weeks|All participants with emicizumab dose up-titration; At the primary completion date, 0 participants in Cohorts A and B, and 2 participants in Cohort C had their dose up-titrated. Due to the smalll sample size, data could not be analyzed on a population level. Data collection is ongoing, and results will be reported upon completion of the study.||||||
2552357|NCT02795767|Secondary|Number of Treated Bleeds Over Time in Participants With Dose Up-Titration|"The number of treated bleeds over time was to be analyzed in participants whose emicizumab maintenance dose was up-titrated to 3 mg/kg QW if they had experienced suboptimal bleeding control on emicizumab at steady-state, per protocol criteria. A bleed is considered a treated bleed if it is directly followed (i.e., no intervening bleed) by a hemophilia medication reported to be a treatment for bleed, irrespective of time between treatment and the preceding bleed. A bleed and the first treatment thereafter and before a new bleed starts, are considered to be pairs, with the following exception: if multiple bleeds occur on the same calendar day, the subsequent treatment is considered to apply for each of these multiple bleeds. The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location are counted as one bleed if the second bleed occurs within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks|All participants with emicizumab dose up-titration; At the primary completion date, 0 participants in Cohorts A and B, and 2 participants in Cohort C had their dose up-titrated. Due to the smalll sample size, data could not be analyzed on a population level. Data collection is ongoing, and results will be reported upon completion of the study.||||||
2552358|NCT02795767|Secondary|Calculated Annualized Bleeding Rate (ABR) for All Bleeds in Treated Participants ≥12 Years of Age and <40 kg Body Weight|"The number of all bleeds over the efficacy period is presented here as a calculated ABR that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. In this outcome measure, all bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded. As all bleeds comprises both treated and non-treated bleeds, the 72-hour rule was implemented separately for treated and non-treated bleeds. For treated bleeds, the 72-hour rule was implemented exactly as defined for the treated bleeds outcome measure. For non-treated bleeds, the 72-hour rule was implemented by calculating a treatment-free period of 72 hours from the bleed itself."|From Baseline to 52 weeks|All participants who received at least one dose of emicizumab and were ≥12 years old and weighed <40 kg at the time of informed consent; none of the participants enrolled in Cohorts B and C fit these criteria.|||all bleed rate per year||Inter-Quartile Range|Median
2552359|NCT02795767|Secondary|Calculated Annualized Bleeding Rate (ABR) for Treated Bleeds in Treated Participants ≥12 Years of Age and <40 kg Body Weight|"The number of treated bleeds over the efficacy period is presented here as a calculated ABR that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. A bleed is considered a treated bleed if it is directly followed (i.e., no intervening bleed) by a hemophilia medication reported to be a treatment for bleed, irrespective of time between treatment and the preceding bleed. A bleed and the first treatment thereafter and before a new bleed starts, are considered to be pairs, with the following exception: if multiple bleeds occur on the same calendar day, the subsequent treatment is considered to apply for each of these multiple bleeds. The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location are counted as one bleed if the second bleed occurs within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks|All participants who received at least one dose of emicizumab and were ≥12 years old and weighed <40 kg at the time of informed consent; none of the participants enrolled in Cohorts B and C fit these criteria.|||treated bleed rate per year||Inter-Quartile Range|Median
2552370|NCT02795767|Secondary|Cohorts B and C: Percentage of Participants by Categorized Number of Treated Spontaneous Bleeds Over the Efficacy Period in Treated Participants <12 Years of Age|"The percentage of participants by categorized number of treated spontaneous bleeds over the efficacy period is presented here. A bleed is classified as spontaneous if there is no other known contributing factor such as trauma or procedure/surgery. A treated spontaneous bleed is a spontaneous bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Treated bleeds that fulfilled the 72-hour rule were included in the analysis of spontaneous bleeds. Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy periods in Cohorts B and C were 21.29 (18.6-24.1) weeks and 19.86 (8.9-24.1) weeks, respectively.|All treated participants in Cohorts B and C who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||percentage of participants||95% Confidence Interval|Number
2552360|NCT02795767|Secondary|Model-Based Annualized Bleeding Rate (ABR) for All Bleeds in Treated Participants ≥12 Years of Age and <40 kg Body Weight|"The number of all bleeds over the efficacy period is presented as a model-based ABR that was analyzed using a negative binomial regression model with efficacy period as an offset to account for the difference in followup times (i.e., the time that each participant stays in the study). In this outcome measure, all bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded. As all bleeds comprises both treated and non-treated bleeds, the 72-hour rule was implemented separately for treated and non-treated bleeds. For treated bleeds, the 72-hour rule was implemented exactly as defined for the treated bleeds outcome measure. For non-treated bleeds, the 72-hour rule was implemented by calculating a treatment-free period of 72 hours from the bleed itself."|From Baseline to 52 weeks|All participants who received at least one dose of emicizumab and were ≥12 years old and weighed <40 kg at the time of informed consent; none of the participants enrolled in Cohorts B and C fit these criteria.|||all bleed rate per year||95% Confidence Interval|Number
2552361|NCT02795767|Secondary|Model-Based Annualized Bleeding Rate (ABR) for Treated Bleeds in Treated Participants ≥12 Years of Age and <40 kg Body Weight|"The number of treated bleeds over the efficacy period is presented here as a model-based ABR that was analyzed using a negative binomial regression model with efficacy period as an offset to account for the difference in follow-up times. A bleed is considered a treated bleed if it is directly followed (i.e., no intervening bleed) by a hemophilia medication reported to be a treatment for bleed, irrespective of time between treatment and the preceding bleed. A bleed and the first treatment thereafter and before a new bleed starts, are considered to be pairs, with the following exception: if multiple bleeds occur on the same calendar day, the subsequent treatment is considered to apply for each of these multiple bleeds. The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location are counted as one bleed if the second bleed occurs within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks|All participants who received at least one dose of emicizumab and were ≥12 years old and weighed <40 kg at the time of informed consent; none of the participants enrolled in Cohorts B and C fit these criteria.|||treated bleed rate per year||95% Confidence Interval|Number
2552362|NCT02795767|Secondary|Cohort A: Intra-Participant Comparison of Percentage of Participants by Categorized Number of All Bleeds on Study Versus Pre-Study in Treated Participants <12 Years of Age From the NIS Population|"This is an intra-participant comparison of the percentage of participants by categorized number of all bleeds over the efficacy period on study versus pre-study in the NIS population who had previously participated in study BH29768 (NCT02476942). In this outcome measure, all bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded. As all bleeds comprises both treated and non-treated bleeds, the 72-hour rule was implemented separately for treated and non-treated bleeds. For treated bleeds, the 72-hour rule was implemented exactly as defined for the treated bleeds outcome measure. For non-treated bleeds, the 72-hour rule was implemented by calculating a treatment-free period of 72 hours from the bleed itself."|Up to 24 weeks in NIS BH29768 (NCT02476942) prior to study entry and from Baseline to 52 weeks on this study; At primary completion date, the median (min-max) duration of the efficacy period in the NIS population was 88.57 (55.9-92.6) weeks.|Treated participants <12 years of age who had participated in NIS BH29768 (NCT02476942) prior to enrollment in this study and were on the same dose of emicizumab for at least 12 weeks in this study|||percentage of participants||95% Confidence Interval|Number
2552363|NCT02795767|Secondary|Cohort A: Intra-Participant Comparison of Percentage of Participants by Categorized Number of Treated Bleeds on Study Versus Pre-Study in Treated Participants <12 Years of Age From the NIS Population|"This is an intra-participant comparison of the percentage of participants by categorized number of treated bleeds over the efficacy period on study versus pre-study in the NIS population who had previously participated in study BH29768 (NCT02476942). A treated bleed is a bleed directly followed by a hemophilia medication reported to be a treatment for bleed, irrespective of time between treatment and the preceding bleed. A bleed and first treatment thereafter are considered to be pairs, with the following exception: if multiple bleeds occur on the same calendar day, the subsequent treatment is considered to apply for each of these multiple bleeds. The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location are counted as one bleed if the second bleed occurs within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure are excluded."|Up to 24 weeks in NIS BH29768 (NCT02476942) prior to study entry and from Baseline to 52 weeks on this study; At primary completion date, the median (min-max) duration of the efficacy period in the NIS population was 88.57 (55.9-92.6) weeks.|Treated participants <12 years of age who had participated in NIS BH29768 (NCT02476942) prior to enrollment in this study and were on the same dose of emicizumab for at least 12 weeks in this study|||percentage of participants||95% Confidence Interval|Number
2552364|NCT02795767|Secondary|Cohort A: Intra-Participant Comparison of the Calculated ABR for All Bleeds on Study Versus Pre-Study in Treated Participants <12 Years of Age From the NIS Population|"This is an intra-participant comparison of the calculated annualized bleeding rate (ABR) for all bleeds (annualized for each participant using the following formula: ABR = [number of bleeds/number of days during the efficacy period] x 365.25) on study versus pre-study in the NIS population who had previously participated in study BH29768 (NCT02476942). In this outcome measure, all bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded. As all bleeds comprises both treated and non-treated bleeds, the 72-hour rule was implemented separately for treated and non-treated bleeds. For treated bleeds, the 72-hour rule was implemented exactly as defined for the treated bleeds outcome measure. For non-treated bleeds, the 72-hour rule was implemented by calculating a treatment-free period of 72 hours from the bleed itself."|Up to 24 weeks in NIS BH29768 (NCT02476942) prior to study entry and from Baseline to 52 weeks on this study; At primary completion date, the median (min-max) duration of the efficacy period in the NIS population was 88.57 (55.9-92.6) weeks.|Treated participants <12 years of age who had participated in NIS BH29768 (NCT02476942) prior to enrollment in this study and were on the same dose of emicizumab for at least 12 weeks in this study|||all bleed rate per year||Inter-Quartile Range|Median
2552650|NCT02791763|Secondary|Percentage of PD Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks|Percentage of PD participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented.|Up to week 52|Efficacy PD Population|||Percentage of participants|||Number
2552365|NCT02795767|Secondary|Cohort A: Intra-Participant Comparison of the Calculated ABR for Treated Bleeds on Study Versus Pre-Study in Treated Participants <12 Years of Age From the NIS Population|"This is an intra-participant comparison of the calculated ABR for treated bleeds (annualized per participant using the following formula: ABR = [number of bleeds/number of days during the efficacy period] x 365.25) on study versus pre-study in the NIS population who had previously participated in study BH29768 (NCT02476942). A treated bleed is a bleed directly followed by a hemophilia medication reported to be a treatment for bleed, irrespective of time between treatment and the preceding bleed. A bleed and first treatment thereafter are considered to be pairs, with the following exception: if multiple bleeds occur on the same calendar day, the subsequent treatment is considered to apply for each of these multiple bleeds. The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location are counted as one bleed if the second bleed occurs within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure are excluded."|Up to 24 weeks in NIS BH29768 (NCT02476942) prior to study entry and from Baseline to 52 weeks on this study; At primary completion date, the median (min-max) duration of the efficacy period in the NIS population was 88.57 (55.9-92.6) weeks.|Treated participants <12 years of age who had participated in NIS BH29768 (NCT02476942) prior to enrollment in this study and were on the same dose of emicizumab for at least 12 weeks in this study|||treated bleed rate per year||Inter-Quartile Range|Median
2552366|NCT02795767|Secondary|Cohort A: Intra-Participant Comparison of the Model-Based ABR for All Bleeds on Study Versus Pre-Study in Treated Participants <12 Years of Age From the NIS Population|"This is an intra-participant comparison of the model-based annualized bleeding rate (ABR) for all bleeds (i.e., number of all bleeds over efficacy period using negative binomial regression model) on study versus pre-study in the NIS population who had previously participated in study BH29768 (NCT02476942). In this outcome measure, all bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded. As all bleeds comprises both treated and non-treated bleeds, the 72-hour rule was implemented separately for treated and non-treated bleeds. For treated bleeds, the 72-hour rule was implemented exactly as defined for the treated bleeds outcome measure. For non-treated bleeds, the 72-hour rule was implemented by calculating a treatment-free period of 72 hours from the bleed itself."|Up to 24 weeks in NIS BH29768 (NCT02476942) prior to study entry and from Baseline to 52 weeks on this study; At primary completion date, the median (min-max) duration of the efficacy period in the NIS population was 88.57 (55.9-92.6) weeks.|Treated participants <12 years of age who had participated in NIS BH29768 (NCT02476942) prior to enrollment in this study and were on the same dose of emicizumab for at least 12 weeks in this study|||all bleed rate per year||95% Confidence Interval|Number
2552367|NCT02795767|Secondary|Cohort A: Intra-Participant Comparison of the Model-Based ABR for Treated Bleeds on Study Versus Pre-Study in Treated Participants <12 Years of Age From the Non-Interventional Study (NIS) Population|"This is an intra-participant comparison of the model-based annualized bleeding rate (ABR) for treated bleeds (i.e., number of treated bleeds over efficacy period using negative binomial regression model) on study versus pre-study in the NIS population who had previously participated in study BH29768 (NCT02476942). A treated bleed is a bleed directly followed by a hemophilia medication reported to be a treatment for bleed, irrespective of time between treatment and the preceding bleed. A bleed and first treatment thereafter are considered to be pairs, with the following exception: if multiple bleeds occur on the same calendar day, the subsequent treatment is considered to apply for each of these multiple bleeds. The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location are counted as one bleed if the second bleed occurs within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure are excluded."|Up to 24 weeks in NIS BH29768 (NCT02476942) prior to study entry and from Baseline to 52 weeks on this study; At primary completion date, the median (min-max) duration of the efficacy period in the NIS population was 88.57 (55.9-92.6) weeks.|Treated participants <12 years of age who had participated in NIS BH29768 (NCT02476942) prior to enrollment in this study and were on the same dose of emicizumab for at least 12 weeks in this study|||treated bleed rate per year||95% Confidence Interval|Number
2552368|NCT02795767|Secondary|Cohorts B and C: Percentage of Participants by Categorized Number of Treated Target Joint Bleeds Over the Efficacy Period in Treated Participants <12 Years of Age|"The percentage of participants by categorized number of treated target joint bleeds over the efficacy period is presented here. A target joint bleed is defined as a joint bleed in a target joint, which is a joint location where at least 3 bleeds have occurred over the last 24 weeks prior to study entry. A treated target joint bleed is a target joint bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy periods in Cohorts B and C were 21.29 (18.6-24.1) weeks and 19.86 (8.9-24.1) weeks, respectively.|All treated participants in Cohorts B and C who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||percentage of participants||95% Confidence Interval|Number
2552369|NCT02795767|Secondary|Cohorts B and C: Percentage of Participants by Categorized Number of Treated Joint Bleeds Over the Efficacy Period in Treated Participants <12 Years of Age|"The percentage of participants by categorized number of treated joint bleeds over the efficacy period is presented here. A joint bleed is defined as a bleed with type reported as joint and with at least one of the following symptoms: increasing swelling or warmth of the skin over the joint and/or increasing pain, decreased range of motion, or difficulty using the joint compared with baseline. A treated joint bleed is a joint bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Only treated bleeds that fulfilled the 72-hour rule were included in the analysis of treated joint bleeds, excluding bleeds due to surgery/procedure."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy periods in Cohorts B and C were 21.29 (18.6-24.1) weeks and 19.86 (8.9-24.1) weeks, respectively.|All treated participants in Cohorts B and C who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||percentage of participants||95% Confidence Interval|Number
2552534|NCT02793154|Primary|Part A: Glucose, Calcium, Magnesium, Potassium, Sodium, Phosphorus Inorganic, Chloride, Urea/Blood Urea Nitrogen (BUN) Levels|Blood samples were collected for analysis of glucose, calcium, magnesium, potassium, sodium, phosphorus inorganic, chloride, and urea/BUN levels. Individual Par. data at indicated time point has been presented.|Day 5|All Subjects Population|||Millimoles per liter|||Number
2552371|NCT02795767|Secondary|Cohorts B and C: Percentage of Participants by Categorized Number of All Bleeds Over the Efficacy Period in Treated Participants <12 Years of Age|"The percentage of participants by categorized number of all bleeds over the efficacy period is presented here. In this outcome measure, all bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded. As all bleeds comprises both treated and non-treated bleeds, the 72-hour rule was implemented separately for treated and non-treated bleeds. For treated bleeds, the 72-hour rule was implemented exactly as defined for the treated bleeds outcome measure. For non-treated bleeds, the 72-hour rule was implemented by calculating a treatment-free period of 72 hours from the bleed itself."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy periods in Cohorts B and C were 21.29 (18.6-24.1) weeks and 19.86 (8.9-24.1) weeks, respectively.|All treated participants in Cohorts B and C who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||percentage of participants||95% Confidence Interval|Number
2552372|NCT02795767|Secondary|Cohorts B and C: Percentage of Participants by Categorized Number of Treated Bleeds Over the Efficacy Period in Treated Participants <12 Years of Age|"The percentage of participants by categorized number of treated bleeds over the efficacy period is presented here. A bleed is considered a treated bleed if it is directly followed (i.e., no intervening bleed) by a hemophilia medication reported to be a treatment for bleed, irrespective of time between treatment and the preceding bleed. A bleed and the first treatment thereafter and before a new bleed starts, are considered to be pairs, with the following exception: if multiple bleeds occur on the same calendar day, the subsequent treatment is considered to apply for each of these multiple bleeds. The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location are counted as one bleed if the second bleed occurs within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy periods in Cohorts B and C were 21.29 (18.6-24.1) weeks and 19.86 (8.9-24.1) weeks, respectively.|All treated participants in Cohorts B and C who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||percentage of participants||95% Confidence Interval|Number
2552373|NCT02795767|Secondary|Cohorts B and C: Calculated Annualized Bleeding Rate (ABR) for Treated Target Joint Bleeds in Treated Participants <12 Years of Age|"The number of treated target joint bleeds over the efficacy period is presented here as a calculated ABR that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. A target joint bleed is defined as a joint bleed in a target joint, which is a joint location where at least 3 bleeds have occurred over the last 24 weeks prior to study entry. A treated target joint bleed is a target joint bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy periods in Cohorts B and C were 21.29 (18.6-24.1) weeks and 19.86 (8.9-24.1) weeks, respectively.|All treated participants in Cohorts B and C who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||treated target joint bleed rate per year||Inter-Quartile Range|Median
2552374|NCT02795767|Secondary|Cohorts B and C: Calculated Annualized Bleeding Rate (ABR) for Treated Joint Bleeds in Treated Participants <12 Years of Age|"The number of treated joint bleeds over the efficacy period is presented here as a calculated ABR that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. A joint bleed is defined as a bleed with type reported as joint and with at least one of the following symptoms: increasing swelling or warmth of the skin over the joint and/or increasing pain, decreased range of motion, or difficulty using the joint compared with baseline. A treated joint bleed is a joint bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Only treated bleeds that fulfilled the 72-hour rule were included in the analysis of treated joint bleeds, excluding bleeds due to surgery/procedure."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy periods in Cohorts B and C were 21.29 (18.6-24.1) weeks and 19.86 (8.9-24.1) weeks, respectively.|All treated participants in Cohorts B and C who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||treated joint bleed rate per year||Inter-Quartile Range|Median
2552375|NCT02795767|Secondary|Cohorts B and C: Calculated Annualized Bleeding Rate (ABR) for Treated Spontaneous Bleeds in Treated Participants <12 Years of Age|"The number of treated spontaneous bleeds over the efficacy period is presented here as a calculated ABR that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. A bleed is classified as spontaneous if there is no other known contributing factor such as trauma or procedure/surgery. A treated spontaneous bleed is a spontaneous bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Treated bleeds that fulfilled the 72-hour rule were included in the analysis of spontaneous bleeds. Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy periods in Cohorts B and C were 21.29 (18.6-24.1) weeks and 19.86 (8.9-24.1) weeks, respectively.|All treated participants in Cohorts B and C who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||treated spontaneous bleed rate per year||Inter-Quartile Range|Median
2552376|NCT02795767|Secondary|Cohorts B and C: Calculated Annualized Bleeding Rate (ABR) for All Bleeds in Treated Participants <12 Years of Age|"The number of all bleeds over the efficacy period is presented here as a calculated ABR that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. In this outcome measure, all bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded. As all bleeds comprises both treated and non-treated bleeds, the 72-hour rule was implemented separately for treated and non-treated bleeds. For treated bleeds, the 72-hour rule was implemented exactly as defined for the treated bleeds outcome measure. For non-treated bleeds, the 72-hour rule was implemented by calculating a treatment-free period of 72 hours from the bleed itself."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy periods in Cohorts B and C were 21.29 (18.6-24.1) weeks and 19.86 (8.9-24.1) weeks, respectively.|All treated participants in Cohorts B and C who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||all bleed rate per year||Inter-Quartile Range|Median
2552377|NCT02795767|Secondary|Cohorts B and C: Calculated Annualized Bleeding Rate (ABR) for Treated Bleeds in Treated Participants <12 Years of Age|"The number of treated bleeds over the efficacy period is presented here as a calculated ABR that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. A bleed is considered a treated bleed if it is directly followed (i.e., no intervening bleed) by a hemophilia medication reported to be a treatment for bleed, irrespective of time between treatment and the preceding bleed. A bleed and the first treatment thereafter and before a new bleed starts, are considered to be pairs, with the following exception: if multiple bleeds occur on the same calendar day, the subsequent treatment is considered to apply for each of these multiple bleeds. The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location are counted as one bleed if the second bleed occurs within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy periods in Cohorts B and C were 21.29 (18.6-24.1) weeks and 19.86 (8.9-24.1) weeks, respectively.|All treated participants in Cohorts B and C who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||treated bleed rate per year||Inter-Quartile Range|Median
2552378|NCT02795767|Secondary|Cohorts B and C: Model-Based Annualized Bleeding Rate (ABR) for Treated Target Joint Bleeds in Treated Participants <12 Years of Age|"The number of treated target joint bleeds over the efficacy period is presented as a model-based ABR that was analyzed using a negative binomial regression model with efficacy period as an offset to account for the difference in follow-up times (i.e., the time that each participant stays in the study). A target joint bleed is defined as a joint bleed in a target joint, which is a joint location where at least 3 bleeds have occurred over the last 24 weeks prior to study entry. A treated target joint bleed is a target joint bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy periods in Cohorts B and C were 21.29 (18.6-24.1) weeks and 19.86 (8.9-24.1) weeks, respectively.|All treated participants in Cohorts B and C who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||treated target joint bleed rate per year||95% Confidence Interval|Number
2552379|NCT02795767|Secondary|Cohorts B and C: Model-Based Annualized Bleeding Rate (ABR) for Treated Joint Bleeds in Treated Participants <12 Years of Age|"The number of treated joint bleeds over the efficacy period is presented as a model-based ABR that was analyzed using a negative binomial regression model with efficacy period as an offset to account for the difference in follow-up times (i.e., the time that each participant stays in the study). A joint bleed is defined as a bleed with type reported as joint and with at least one of the following symptoms: increasing swelling or warmth of the skin over the joint and/or increasing pain, decreased range of motion, or difficulty using the joint compared with baseline. A treated joint bleed is a joint bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Only treated bleeds that fulfilled the 72-hour rule were included in the analysis of treated joint bleeds, excluding bleeds due to surgery/procedure."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy periods in Cohorts B and C were 21.29 (18.6-24.1) weeks and 19.86 (8.9-24.1) weeks, respectively.|All treated participants in Cohorts B and C who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||treated joint bleed rate per year||95% Confidence Interval|Number
2552380|NCT02795767|Secondary|Cohorts B and C: Model-Based Annualized Bleeding Rate (ABR) for Treated Spontaneous Bleeds in Treated Participants <12 Years of Age|"The number of treated spontaneous bleeds over the efficacy period is presented as a model-based ABR that was analyzed using a negative binomial regression model with efficacy period as an offset to account for the difference in follow-up times (i.e., the time that each participant stays in the study). A bleed is classified as spontaneous if there is no other known contributing factor such as trauma or procedure/surgery. A treated spontaneous bleed is a spontaneous bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Treated bleeds that fulfilled the 72-hour rule were included in the analysis of spontaneous bleeds. Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy periods in Cohorts B and C were 21.29 (18.6-24.1) weeks and 19.86 (8.9-24.1) weeks, respectively.|All treated participants in Cohorts B and C who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||treated spontaneous bleed rate per year||95% Confidence Interval|Number
2552381|NCT02795767|Secondary|Cohorts B and C: Model-Based Annualized Bleeding Rate (ABR) for All Bleeds in Treated Participants <12 Years of Age|"The number of all bleeds over the efficacy period is presented as a model-based ABR that was analyzed using a negative binomial regression model with efficacy period as an offset to account for the difference in follow-up times (i.e., the time that each participant stays in the study). In this outcome measure, all bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded. As all bleeds comprises both treated and non-treated bleeds, the 72-hour rule was implemented separately for treated and non-treated bleeds. For treated bleeds, the 72-hour rule was implemented exactly as defined for the treated bleeds outcome measure. For non-treated bleeds, the 72-hour rule was implemented by calculating a treatment-free period of 72 hours from the bleed itself."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy periods in Cohorts B and C were 21.29 (18.6-24.1) weeks and 19.86 (8.9-24.1) weeks, respectively.|All treated participants in Cohorts B and C who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||all bleed rate per year||95% Confidence Interval|Number
2552404|NCT02794870|Secondary|Magnitude of Serum RSV-neutralizing Antibody Responses in the Vaccine and Placebo Recipients Who Experienced Natural Infection With wt RSV During the Subsequent RSV Season.|Only participants who had RSV detected in nasal washes or a greater than or equal to 4-fold rise in serum antibodies during the subsequent RSV season were included. RSV-neutralizing antibody titers were measured pre- and post-RSV surveillance season subsequent to the time of the inoculation.|Measured through participant's last study visit, up to a total of 6 to 10 months depending on when participants enrolled in the study|Only participants who had RSV detected in nasal washes or a greater than or equal to 4-fold rise in serum antibodies during the subsequent RSV season were included.|||log 2 titers||Inter-Quartile Range|Median
2552382|NCT02795767|Secondary|Cohorts B and C: Model-Based Annualized Bleeding Rate (ABR) for Treated Bleeds in Treated Participants <12 Years of Age|"The number of treated bleeds over the efficacy period is presented as a model-based ABR that was analyzed using a negative binomial regression model with efficacy period as an offset to account for the difference in follow-up times. A bleed is considered a treated bleed if it is directly followed (i.e., no intervening bleed) by a hemophilia medication reported to be a treatment for bleed, irrespective of time between treatment and the preceding bleed. A bleed and the first treatment thereafter and before a new bleed starts, are considered to be pairs, with the following exception: if multiple bleeds occur on the same calendar day, the subsequent treatment is considered to apply for each of these multiple bleeds. The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location are counted as one bleed if the second bleed occurs within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy periods in Cohorts B and C were 21.29 (18.6-24.1) weeks and 19.86 (8.9-24.1) weeks, respectively.|All treated participants in Cohorts B and C who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||treated bleed rate per year||95% Confidence Interval|Number
2552383|NCT02795767|Primary|Cohort A: Percentage of Participants by Categorized Number of Treated Target Joint Bleeds Over the Efficacy Period in Treated Participants <12 Years of Age|"The percentage of participants by categorized number of treated target joint bleeds over the efficacy period is presented here. A target joint bleed is defined as a joint bleed in a target joint, which is a joint location where at least 3 bleeds have occurred over the last 24 weeks prior to study entry. A treated target joint bleed is a target joint bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy period in Cohort A was 57.57 (17.9-92.6) weeks.|All treated participants in Cohort A who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||percentage of participants||95% Confidence Interval|Number
2552384|NCT02795767|Primary|Cohort A: Percentage of Participants by Categorized Number of Treated Joint Bleeds Over the Efficacy Period in Treated Participants <12 Years of Age|"The percentage of participants by categorized number of treated joint bleeds over the efficacy period is presented here. A joint bleed is defined as a bleed with type reported as joint and with at least one of the following symptoms: increasing swelling or warmth of the skin over the joint and/or increasing pain, decreased range of motion, or difficulty using the joint compared with baseline. A treated joint bleed is a joint bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Only treated bleeds that fulfilled the 72-hour rule were included in the analysis of treated joint bleeds, excluding bleeds due to surgery/procedure."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy period in Cohort A was 57.57 (17.9-92.6) weeks.|All treated participants in Cohort A who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||percentage of participants||95% Confidence Interval|Number
2552385|NCT02795767|Primary|Cohort A: Percentage of Participants by Categorized Number of Treated Spontaneous Bleeds Over the Efficacy Period in Treated Participants <12 Years of Age|"The percentage of participants by categorized number of treated spontaneous bleeds over the efficacy period is presented here. A bleed is classified as spontaneous if there is no other known contributing factor such as trauma or procedure/surgery. A treated spontaneous bleed is a spontaneous bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Treated bleeds that fulfilled the 72-hour rule were included in the analysis of spontaneous bleeds. Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy period in Cohort A was 57.57 (17.9-92.6) weeks.|All treated participants in Cohort A who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||percentage of participants||95% Confidence Interval|Number
2552386|NCT02795767|Primary|Cohort A: Percentage of Participants by Categorized Number of All Bleeds Over the Efficacy Period in Treated Participants <12 Years of Age|"The percentage of participants by categorized number of all bleeds over the efficacy period is presented here. In this outcome measure, all bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded. As all bleeds comprises both treated and non-treated bleeds, the 72-hour rule was implemented separately for treated and non-treated bleeds. For treated bleeds, the 72-hour rule was implemented exactly as defined for the treated bleeds outcome measure. For non-treated bleeds, the 72-hour rule was implemented by calculating a treatment-free period of 72 hours from the bleed itself."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy period in Cohort A was 57.57 (17.9-92.6) weeks.|All treated participants in Cohort A who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||percentage of participants||95% Confidence Interval|Number
2552387|NCT02795767|Primary|Cohort A: Percentage of Participants by Categorized Number of Treated Bleeds Over the Efficacy Period in Treated Participants <12 Years of Age|"The percentage of participants by categorized number of treated bleeds over the efficacy period is presented here. A bleed is considered a treated bleed if it is directly followed (i.e., no intervening bleed) by a hemophilia medication reported to be a treatment for bleed, irrespective of time between treatment and the preceding bleed. A bleed and the first treatment thereafter and before a new bleed starts, are considered to be pairs, with the following exception: if multiple bleeds occur on the same calendar day, the subsequent treatment is considered to apply for each of these multiple bleeds. The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location are counted as one bleed if the second bleed occurs within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy period in Cohort A was 57.57 (17.9-92.6) weeks.|All treated participants in Cohort A who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||percentage of participants||95% Confidence Interval|Number
2552535|NCT02793154|Primary|Part A: Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT) Levels at Indicated Time Points|Blood samples were collected for analysis of clinical chemistry parameters including ALT, AST and GGT. Individual Par. data at indicated time point has been presented.|Day 5|All Subjects Population|||International unit per liter|||Number
2552388|NCT02795767|Primary|Cohort A: Calculated Annualized Bleeding Rate (ABR) for Treated Target Joint Bleeds in Treated Participants <12 Years of Age|"The number of treated target joint bleeds over the efficacy period is presented here as a calculated ABR that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. A target joint bleed is defined as a joint bleed in a target joint, which is a joint location where at least 3 bleeds have occurred over the last 24 weeks prior to study entry. A treated target joint bleed is a target joint bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy period in Cohort A was 57.57 (17.9-92.6) weeks.|All treated participants in Cohort A who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||treated target joint bleed rate per year||Inter-Quartile Range|Median
2552389|NCT02795767|Primary|Cohort A: Calculated Annualized Bleeding Rate (ABR) for Treated Joint Bleeds in Treated Participants <12 Years of Age|"The number of treated joint bleeds over the efficacy period is presented here as a calculated ABR that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. A joint bleed is defined as a bleed with type reported as joint and with at least one of the following symptoms: increasing swelling or warmth of the skin over the joint and/or increasing pain, decreased range of motion, or difficulty using the joint compared with baseline. A treated joint bleed is a joint bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Only treated bleeds that fulfilled the 72-hour rule were included in the analysis of treated joint bleeds, excluding bleeds due to surgery/procedure."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy period in Cohort A was 57.57 (17.9-92.6) weeks.|All treated participants in Cohort A who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||treated joint bleed rate per year||Inter-Quartile Range|Median
2552390|NCT02795767|Primary|Cohort A: Calculated Annualized Bleeding Rate (ABR) for Treated Spontaneous Bleeds in Treated Participants <12 Years of Age|"The number of treated spontaneous bleeds over the efficacy period is presented here as a calculated ABR that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. A bleed is classified as spontaneous if there is no other known contributing factor such as trauma or procedure/surgery. A treated spontaneous bleed is a spontaneous bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Treated bleeds that fulfilled the 72-hour rule were included in the analysis of spontaneous bleeds. Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy period in Cohort A was 57.57 (17.9-92.6) weeks.|All treated participants in Cohort A who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||treated spontaneous bleed rate per year||Inter-Quartile Range|Median
2552391|NCT02795767|Primary|Cohort A: Calculated Annualized Bleeding Rate (ABR) for All Bleeds in Treated Participants <12 Years of Age|"The number of all bleeds over the efficacy period is presented here as a calculated ABR that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. In this outcome measure, all bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded. As all bleeds comprises both treated and non-treated bleeds, the 72-hour rule was implemented separately for treated and non-treated bleeds. For treated bleeds, the 72-hour rule was implemented exactly as defined for the treated bleeds outcome measure. For non-treated bleeds, the 72-hour rule was implemented by calculating a treatment-free period of 72 hours from the bleed itself."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy period in Cohort A was 57.57 (17.9-92.6) weeks.|All treated participants in Cohort A who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||all bleed rate per year||Inter-Quartile Range|Median
2552392|NCT02795767|Primary|Cohort A: Calculated Annualized Bleeding Rate (ABR) for Treated Bleeds in Treated Participants <12 Years of Age|"The number of treated bleeds over the efficacy period is presented here as a calculated ABR that was annualized for each participant using the following formula: ABR = (number of bleeds/number of days during the efficacy period) x 365.25. A bleed is considered a treated bleed if it is directly followed (i.e., no intervening bleed) by a hemophilia medication reported to be a treatment for bleed, irrespective of time between treatment and the preceding bleed. A bleed and the first treatment thereafter and before a new bleed starts, are considered to be pairs, with the following exception: if multiple bleeds occur on the same calendar day, the subsequent treatment is considered to apply for each of these multiple bleeds. The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location are counted as one bleed if the second bleed occurs within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy period in Cohort A was 57.57 (17.9-92.6) weeks.|All treated participants in Cohort A who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||treated bleed rate per year||Inter-Quartile Range|Median
2552393|NCT02795767|Primary|Cohort A: Model-Based Annualized Bleeding Rate (ABR) for Treated Target Joint Bleeds in Treated Participants <12 Years of Age|"The number of treated target joint bleeds over the efficacy period is presented here as a model-based ABR that was analyzed using a negative binomial regression model with efficacy period as an offset to account for the difference in follow-up times (i.e., the time that each participant stays in the study). A target joint bleed is defined as a joint bleed in a target joint, which is a joint location where at least 3 bleeds have occurred over the last 24 weeks prior to study entry. A treated target joint bleed is a target joint bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy period in Cohort A was 57.57 (17.9-92.6) weeks.|All treated participants in Cohort A who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||treated target joint bleed rate per year||95% Confidence Interval|Number
2552536|NCT02793154|Primary|Part A: Hematocrit Level at Indicated Time Points|Blood samples were collected for analysis of hematocrit level. Individual Par. data at indicated time points has been presented.|Day 5|All Subjects Population|||Proportion of RBC in blood|||Number
2552394|NCT02795767|Primary|Cohort A: Model-Based Annualized Bleeding Rate (ABR) for Treated Joint Bleeds in Treated Participants <12 Years of Age|"The number of treated joint bleeds over the efficacy period is presented here as a model-based ABR that was analyzed using a negative binomial regression model with efficacy period as an offset to account for the difference in follow-up times (i.e., the time that each participant stays in the study). A joint bleed is defined as a bleed with type reported as joint and with at least one of the following symptoms: increasing swelling or warmth of the skin over the joint and/or increasing pain, decreased range of motion, or difficulty using the joint compared with baseline. A treated joint bleed is a joint bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Only treated bleeds that fulfilled the 72-hour rule were included in the analysis of treated joint bleeds, excluding bleeds due to surgery/procedure."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy period in Cohort A was 57.57 (17.9-92.6) weeks.|All treated participants in Cohort A who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||treated joint bleed rate per year||95% Confidence Interval|Number
2552395|NCT02795767|Primary|Cohort A: Model-Based Annualized Bleeding Rate (ABR) for Treated Spontaneous Bleeds in Treated Participants <12 Years of Age|"The number of treated spontaneous bleeds over the efficacy period is presented here as a model-based ABR that was analyzed using a negative binomial regression model with efficacy period as an offset to account for the difference in follow-up times (i.e., the time that each participant stays in the study). A bleed is classified as spontaneous if there is no other known contributing factor such as trauma or procedure/surgery. A treated spontaneous bleed is a spontaneous bleed that also fulfills the conditions of a treated bleed (see ABR for Treated Bleeds for the definition). Treated bleeds that fulfilled the 72-hour rule were included in the analysis of spontaneous bleeds. Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy period in Cohort A was 57.57 (17.9-92.6) weeks.|All treated participants in Cohort A who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||treated spontaneous bleed rate per year||95% Confidence Interval|Number
2552396|NCT02795767|Primary|Cohort A: Model-Based Annualized Bleeding Rate (ABR) for All Bleeds in Treated Participants <12 Years of Age|"The number of all bleeds over the efficacy period is presented here as a model-based ABR that was analyzed using a negative binomial regression model with efficacy period as an offset to account for the difference in followup times (i.e., the time that each participant stays in the study). In this outcome measure, all bleeds are included, irrespective of treatment with coagulation factors, with the following exception: bleeds due to surgery/procedure are excluded. As all bleeds comprises both treated and non-treated bleeds, the 72-hour rule was implemented separately for treated and non-treated bleeds. For treated bleeds, the 72-hour rule was implemented exactly as defined for the treated bleeds outcome measure. For non-treated bleeds, the 72-hour rule was implemented by calculating a treatment-free period of 72 hours from the bleed itself."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy period in Cohort A was 57.57 (17.9-92.6) weeks.|All treated participants in Cohort A who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||all bleed rate per year||95% Confidence Interval|Number
2552397|NCT02795767|Primary|Cohort A: Model-Based Annualized Bleeding Rate (ABR) for Treated Bleeds in Treated Participants <12 Years of Age|"The number of treated bleeds over the efficacy period is presented here as a model-based ABR that was analyzed using a negative binomial regression model with efficacy period as an offset to account for the difference in follow-up times. A bleed is considered a treated bleed if it is directly followed (i.e., no intervening bleed) by a hemophilia medication reported to be a treatment for bleed, irrespective of time between treatment and the preceding bleed. A bleed and the first treatment thereafter and before a new bleed starts, are considered to be pairs, with the following exception: if multiple bleeds occur on the same calendar day, the subsequent treatment is considered to apply for each of these multiple bleeds. The 72-hour rule was implemented: two bleeds of the same type and at the same anatomical location are counted as one bleed if the second bleed occurs within 72 hours from the last treatment for the first bleed. Bleeds due to surgery/procedure are excluded."|From Baseline to 52 weeks; At the primary completion date, the median (min-max) duration of the efficacy period in Cohort A was 57.57 (17.9-92.6) weeks.|All treated participants in Cohort A who were on the same dose of emicizumab for at least 12 weeks and were <12 years of age|||treated bleed rate per year||95% Confidence Interval|Number
2552398|NCT02794974|Secondary|Dysphagia|number of participants who experienced side effects: dysphagia|intraoperatively||||participants|||Number
2552399|NCT02794974|Secondary|Cough|number of participants who experienced side effects: cough|intraoperatively||||participants|||Number
2552400|NCT02794974|Secondary|Hoarseness|number of participants who experienced side effects: hoarseness|intraoperatively||||participants|||Number
2552401|NCT02794974|Primary|Local Anesthetic Supplementation (Volume)|volume of prilocaine 1% supplemented by the surgeon (ml)|intraoperatively||||ml||Standard Deviation|Mean
2552402|NCT02794974|Primary|Local Anesthetic Supplementation (Frequency)|number of participants who need supplementation of prilocaine 1% by the surgeon (%)|intraoperatively||||participants|||Number
2552403|NCT02794870|Secondary|Number of Participants With B Cell Responses to Vaccine|A B cell response to vaccine is indicated by a greater than or equal to 4-fold change in serum antibody titers to RSV F glycoprotein between the pre- and post-inoculation time points, and between pre- and post-RSV surveillance time points.|Measured through participant's last study visit, up to a total of 6 to 10 months depending on when participants enrolled in the study|One vaccine recipient had missing data for the post-RSV surveillance time point, and one placebo recipient had missing data for the pre- and post-RSV surveillance time points. All other participants who received inoculation and were followed on study past Day 0 were included.|||Participants|||Count of Participants
2552432|NCT02794441|Secondary|Persistent Pain Freedom|Persistent pain freedom, defined as the proportion of patients in each group who achieved pain freedom at 2 hours (or at the time of ED discharge if prior to 2 hours) and were free of pain without the use of rescue medication at 48 hours, will be assessed|2 hours post-intervention (or at the time of ED discharge if prior to 2 hours) and 48 hours||||Participants|||Count of Participants
2559654|NCT02674204|Secondary|Change in Global Longitudinal Strain as Measured by CMRI||Baseline to 12 months of follow-up|As accrual fell well below target, change in global longitudinal strain as measured by CMRI was not calculated.||||||
2552405|NCT02794870|Secondary|Number of Participants Who Had Symptomatic, Medically Attended Respiratory and Febrile Illness, by Grade, Among Those Who Experienced Natural Infection With wt RSV During the Subsequent RSV Season|The number of participants who had symptomatic, medically attended respiratory and febrile illness among those who had RSV detected in nasal washes or greater than or equal to 4 fold rise in serum antibodies during the subsequent RSV season were presented. A participant was only counted once in each solicited AE category, and that was in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 4 and Table 5 in the protocol document.|Measured through participant's last study visit, up to a total of 6 to 10 months depending on when participants enroll in the study|Only participants who had RSV detected in nasal washes or greater than or equal to 4 fold rise in serum antibodies during the subsequent RSV season were included.|||Participants|||Count of Participants
2552406|NCT02794870|Primary|Serum Antibody Responses to RSV F Glycoprotein as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)|Immunogenicity was assessed at approximately 2 months post-inoculation (Study Day 56).|Measured at Day 56|Study participants who received inoculation and were followed on study past Day 0 were included.|||log 2 titers||Inter-Quartile Range|Median
2552407|NCT02794870|Primary|Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titer|Immunogenicity was assessed pre-inoculation, and at approximately 2 months post-inoculation (Study Day 56). Antibody responses were defined as a greater than or equal to 4-fold increase in titer in paired specimens, between pre-inoculation and post-inoculation time points.|Measured at Day 0 and Day 56|Study participants who received inoculation and were followed on study past Day 0 were included.|||Participants|||Count of Participants
2552408|NCT02794870|Primary|Duration of Virus Shedding in Nasal Washes|Determined separately by a) culture and b) reverse transcription polymerase chain reaction (RT-PCR)|Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28. Last day positive is reported.|Only participants who met the definition of infection with vaccine virus were included.|||days||Inter-Quartile Range|Median
2552409|NCT02794870|Primary|Peak Titer of Vaccine Virus Shed|This is the highest value per participant of the titer of vaccine virus shed. It was measured by culture. Only participants who met the definition of infection with vaccine virus were included.|Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28|Only participants who met the definition of infection with vaccine virus were included.|||log10 PFU/mL||Inter-Quartile Range|Median
2552410|NCT02794870|Primary|Number of Participants Infected With RSV Vaccine|Defined as 1) vaccine virus identified in a nasal wash from Study Day 0-28 (a binary outcome based on nasal washes) or 2) greater than or equal to 4-fold rise in serum RSV-neutralizing antibody titer between Study Days 0 and 56.|Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28 for nasal washes, and at Days 0, 56 for serum RSV-neutralizing antibodies|Study participants who received inoculation and were followed on study past Day 0 were included.|||Participants|||Count of Participants
2552411|NCT02794870|Primary|Number of Participants With Serious Adverse Events (SAEs)|"A Serious Adverse Event (SAE) is an AE, whether considered related to the study product or not, that:~Results in death during the period of protocol-defined surveillance~Is life threatening: defined as an event in which the patient was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death were it more severe~Requires inpatient hospitalization (or prolongation of existing hospitalization): defined as at least an overnight stay in the hospital or emergency ward for treatment that would have been inappropriate if administered in the outpatient setting~Results in a persistent or significant disability/incapacity~Is a congenital anomaly or birth defect~Is an important medical event that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed above."|Measured from Day 0 through Day 56|Study participants who received inoculation and were followed on study past Day 0 were included.|||Participants|||Count of Participants
2552412|NCT02794870|Primary|Number of Participants With Unsolicited AEs by Grade|Unsolicited adverse events were other events, not included in the solicited AEs. The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each unsolicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. AE grading (Grade 1- mild to Grade 4-life-threatening) was done by DAIDS AE Grading table v2.0 (see References).|Measured from Day 0 through Day 28|Study participants who received inoculation and were followed on study past Day 0 were included.|||Participants|||Count of Participants
2552413|NCT02794870|Primary|Number of Participants With Solicited Adverse Events (AEs) by Grade|Solicited adverse events included fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and cough (without LRI). The number of participants who experienced solicited adverse events was presented. A participant was only counted once in each solicited AE category, and that is in the line corresponding to the highest grade adverse event they had in that category. These events were graded (Grade 1-mild to Grade 4-life-threatening) following protocol-defined grading system outlined in Table 4 and Table 5 in the protocol document.|Measured from Day 0 through Day 28|Study participants who received inoculation and were followed on study past Day 0 were included.|||Participants|||Count of Participants
2552414|NCT02794844|Primary|Adverse Effects After Genotype-guided PPI Therapy|Count of participants reporting adverse effects after genotype-guided PPI therapy.|Throughout 12 month study||||Participants|||Count of Participants
2552415|NCT02794844|Primary|Count of Participants Agreeing to Future Use of DNA|Outcomes for evaluating the success of PGX implementation|Throughout 12 month study||||Participants|||Count of Participants
2552416|NCT02794844|Primary|Count of Providers Agreeing to Participate in Study|Outcomes for evaluating the success of PGX implementation|Throughout 12 month study|6 providers participated in the study|||Participants|||Count of Participants
2552417|NCT02794844|Primary|Count of Patients Reporting Efficacy and Toxicity Data|Outcomes for evaluating the success of PGX implementation|Throughout 12 month study||||Participants|||Count of Participants
2552418|NCT02794844|Primary|Count of Patients Agreeing to Volunteer for the Study|Outcomes for evaluating the success of PGX implementation|Through 12 months study||||Participants|||Count of Participants
2552419|NCT02794727|Primary|Change in Fitbit Step Count Per Day|change in number of daily steps as measured by the fitbit monitor|Baseline through Week 16||||steps||Standard Error|Least Squares Mean
2552420|NCT02794480|Post-Hoc|Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase|A supportive post-hoc analysis on the primary endpoint was performed to address possible concerns due to the exclusion of data from a large number of participants who made no errors or at least one error on either inhaler tested in the primary analysis (only discordant cases involved in the analysis). For each ELLIPTA versus MDI comparison separately (Sub-study 1: Ellipta vs GSK MDI and Sub-study 2: Ellipta vs AZ MDI), the percentage of par having zero errors in inhaler use at Day 28 was analyzed using a Conditional Logistic Regression adjusting for treatment (inhaler) and treatment period. NA indicates that the par did not receive the inhaler in that particular sub-study.|Up to Day 56|MITT|||Percentage of Participants|||Number
2552421|NCT02794480|Secondary|Number of Errors Per Participant for Each After 28 Days of Use (Par With at Least One Error)|The number of errors for each inhaler (ELLIPTA and GSK MDI or AZ MDI) in par with one or more errors were evaluated based on the information collected in the Correct Use Checklists. The number of errors per par was summarised as continuous data by inhaler for each of the ELLIPTA versus MDI comparisons. NA indicates that the par. did not receive the inhaler in that particular sub-study. Only those par who made at least one error were included in the summary (represented by n=X, X in the category titles).|Up to Day 56|MITT Population|||Errors||Standard Deviation|Mean
2552422|NCT02794480|Secondary|Number of Errors Per Participant for Each Inhaler After 28 Days of Use (All Evaluable Par)|The number of errors per par for each inhaler (ELLIPTA and GSK MDI or AZ MDI) was evaluated based on the information collected in the Correct Use Checklists. The number of errors per par was summarised as continuous data by inhaler for each of the ELLIPTA versus MDI comparisons. NA indicates that the par did not receive the inhaler in that particular sub-study.|Up to Day 56|MITT Population|||Errors||Standard Deviation|Mean
2552423|NCT02794480|Secondary|Frequency of Errors by Type for MDI After 28 Days of Use in Each Treatment Phase|The occurrence of each type of error while using GSK MDI in Sub-Study 1 and AZ MDI in Sub-Study 2 was evaluated based on the information collected in the Correct Use Checklists. The number of errors for each type of inhaler was assessed at Visit 2 and Visit 3. The par were counted more than once depending on the reasons for incorrect use. The number of errors is reported as NA for the type of error which was not applicable to the particular inhaler type. Only par who made at least one error are included in the summary (represented by the number of Participants).|Up to Day 56|MITT Population|||Participants|||Number
2552424|NCT02794480|Secondary|Frequency of Errors by Type for ELLIPTA After 28 Days of Use in Each Treatment Phase|The occurrence of each type of error while using ELLIPTA inhaler was evaluated based on the information collected in the Correct Use Checklists. The number of errors for each type of inhaler was assessed at Visit 2 and Visit 3. The par were counted more than once depending on the reasons for incorrect use. Only par who made at least one error was included in the summary (represented by the number of Participants).|Up to Day 56|MITT Population|||Participants|||Number
2552425|NCT02794480|Primary|Percentage of Participants With Zero Errors in ELLIPTA DPI Versus GSK MDI and AZ MDI After 28 Days of Use in Each Treatment Phase|A checklist for correct use of each inhaler was developed based on the steps identified in the package insert. Baseline assessment was conducted when the par were dispensed the inhaler and were guided by a trained healthcare provider (HCP) to demonstrate correct use of the assigned inhaler. A second assessment was conducted after each 28 day dosing period without instruction by HCP. The Correct Use Check list was completed by HCP at each visit. Percentage of par with zero errors in inhaler use at Day 28, was analyzed using a Mainland-Gart test for each ELLIPTA versus MDI comparison separately (Sub-study 1: ELLIPTA vs GSK MDI and Sub-study 2: ELLIPTA vs AZ MDI). For each ELLIPTA vs MDI analyses, only par who made no error in any of the inhalers and at least one error on the other inhaler (discordant cases) were included in the analysis. NA indicates that par did not receive the inhaler in that particular sub-study.|Up to Day 56|Modified ITT Population (MITT) comprises of all par in the ITT Population who provided Day 28 inhaler use data for both of their randomized inhalers.|||Percentage of Participants|||Number
2552426|NCT02794441|Secondary|Adverse Events at 7 Days Post-discharge|Adverse events will be queried at 2 hours (or at the time of ED discharge if prior to 2 hours), at discharge and in the follow-up questionnaires at 48 hours and 7 days. Reported here are the adverse events at the 7 day follow-up post-discharge.|2 hours post-intervention (or at the time of ED discharge if prior to 2 hours), at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours), 48 hours and 7 days||||Participants|||Count of Participants
2552427|NCT02794441|Secondary|Adverse Events at 48 Hours Post-discharge|Adverse events will be queried at 2 hours (or at the time of ED discharge if prior to 2 hours), at discharge and in the follow-up questionnaires at 48 hours and 7 days. Reported here are the adverse events at the 48 hour follow-up post-discharge.|2 hours post-intervention (or at the time of ED discharge if prior to 2 hours), at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours), 48 hours and 7 days||||Participants|||Count of Participants
2552428|NCT02794441|Secondary|Adverse Events at Discharge|Adverse events will be queried at 2 hours (or at the time of ED discharge if prior to 2 hours), at discharge and in the follow-up questionnaires at 48 hours and 7 days. Reported here are the adverse events at the time of ED discharge. All patients were discharged prior to the 2 hour time point. Adverse events reported at follow-up are reported elsewhere (see below).|2 hours post-intervention (or at the time of ED discharge if prior to 2 hours), at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours), 48 hours and 7 days||||Participants|||Count of Participants
2552429|NCT02794441|Secondary|Revisits Within 7 Days of Discharge From the ED|The number of patients with return ED visits within 7 days of ED discharge will be assessed through chart review.|7 days||||Participants|||Count of Participants
2552430|NCT02794441|Secondary|Headache Recurrence at 7 Day Follow-up|The proportion of patients in each group with recurrence within the 7 days following ED discharge will be assessed.|7 days||||Participants|||Count of Participants
2552431|NCT02794441|Secondary|Patient Satisfaction|Patient satisfaction will be assessed at the time of discharge from the ED and again at follow-up with the following 5-point Likert scale: 5=very satisfied, 4=satisfied, 3=neutral, 2=unsatisfied, 1=very unsatisfied. Here we report patient satisfaction rates at discharge.|At the time of discharge from the ED (expected median duration in the ED post-treatment = 3 hours), at 48 hours and at 7 day follow-up||||Participants|||Count of Participants
2552433|NCT02794441|Secondary|Pain Intensity|Pain intensity will be measured on a 4 point rating scale as recommended by the International Headache Society guidelines: a) 0=none, b) 1=mild, c) 2= moderate, d) 4=severe. It will be assessed at 2 hours post-baseline, or at the time of ED discharge if prior to 2 hours and at the time of ED discharge where this exceeds 2 hours post-intervention. Because all participants were discharged prior to 2 hours, we report the pain intensity at the time of ED discharge.|Baseline, 2 hours post-intervention (or at the time of ED discharge if prior to 2 hours) and at the time of discharge from the Emergency Department (ED) if post-treatment ED duration extends beyond 2 hours (expected median duration = 3 hours)||||Participants|||Count of Participants
2552434|NCT02794441|Primary|Headache Recurrence at 48 Hours|The primary outcome will be headache recurrence 48 hours after discharge from the ED. Headache recurrence will be defined as: for patients who were pain-free at ED discharge (ie. pain intensity of 0), any return of head pain (ie. pain intensity of 1 or greater) will be coded as a recurrence, and for patients who had persistent head pain at discharge, an increase in head pain since ED discharge will be coded as recurrence as well (ie. an increase in their score on the 4-point scale as compared to their score at ED discharge).|48 hours||||Participants|||Count of Participants
2552435|NCT02794246|Primary|Evaluate Progression Free Survival|Progression free survival as defined by Partial Response (PR); Stable Disease (SD); Very Good Partial Response (VGPR), and Stringent Complete Response (sCR) to treatment. The outcome measures range from Stable disease to Stringent Complete Response (SD worst outcome; sCR best outcome|Follow progression-free survival (PFS) for 2-3 years post CART-19 infusion||||participants|||Number
2552436|NCT02794207|Primary|Issues Related to Type of Neutropenia Management That Are Most Important to Children and Their Caregivers.|Issues related to type of neutropenia management are not quantifiable. All interviewees gave unique responses to issues related to neutropenia management, and themes were identified after all interviews were conducted and analyzed.|One qualitative semi-structured interview was conducted post-neutropenia management. The interview lasted about 30-45 minutes.|All participants (patients and caregivers) who participated in the semi-structured interviews. 3 key, novel themes were identified across these interviews.|||key themes identified|||Number
2552437|NCT02794103|Secondary|Sedation Level|Ramsay sedation scale - ranging from 1 (anxious or restless or both) to 6 (no response to stimulus)|T2, before the procedure, upon arrival in the hydrotherapy room, T3, during the procedure (10 min after the beginning of the hydrotherapy session), T4, immediately after the procedure before leaving the hydrotherapy room||||units on the RSS||Inter-Quartile Range|Median
2552438|NCT02794103|Secondary|Number of Participants With Additional Analgesic Requirement|Number of Participants who needed additional (rescue dose) medication administration|T3, during the procedure (10 min after the beginning of the hydrotherapy session)||||Participants|||Count of Participants
2552439|NCT02794103|Secondary|Comfort Level|Behavioural observation scale of comfort level for child burn victims (OCCEB- BECCO) - an observational scale that assesses comfort during hydrotherapy procedure with scores ranging from 0 to 10: 0 = most comfortable, 10 = least comfortable.|T3, during the procedure (10 min after the beginning of the hydrotherapy session)||||units on a scale from 0-10||Standard Deviation|Mean
2552440|NCT02794103|Secondary|Anxiety Level|Procedure Behaviour Check List (PBCL)- a behavioral scale that assesses anxiety based on 8 behaviors: muscular tension, screaming, crying, use of restraints, verbalization of pain, verbalization of anxiety, verbal stalling, and physical resistance. Each behavior is evaluated on a scale ranging from 1 (very slightly) to 5 (extremely intense) for a possible final score between 8 and 40, with a value of 8 meaning least anxious and 40 = most anxious.|T2, upon arrival at the hydrotherapy room; T3, 10 min after the beginning of the hydrotherapy session; T4, immediately after the session before leaving hydrotherapy room; T5, 30 min. after the session|Missing data due to either high sedation level after the procedure or to the inability to verbalize anxiety which is required for measurement|||units on a scale from 8-40||Standard Deviation|Mean
2552441|NCT02794103|Secondary|Pain Intensity|"Face, Legs, Activity, Cry and Consolability (FLACC)- Behavioral pain assessment scale for children from 0 to 18 years old that includes five separate items with each item scored on a range from 0 to 2 to provide a total score of pain from 0 to 10.~Interpretation: 0= relaxed and comfortable, 1-3= Mild discomfort, 4-6= Moderate pain, and 7-10 = severe discomfort/pain."|T1, 30 minutes before the procedure (patient`s room); T2, upon arrival at the hydrotherapy room; T3, 10 min after the beginning of the hydrotherapy session; T4, immediately after the session before leaving hydrotherapy room; T5, 30 min. after the session|Missing data due to high sedation levels before or after the procedure|||units on a scale from 0-10||Standard Deviation|Mean
2552442|NCT02794103|Primary|Acceptability|To assess the acceptability including the satisfaction of healthcare professionals regarding the use of the VR prototype during the hydrotherapy session. Pre-tested tailored questionnaire including satisfaction and acceptability outcomes (tolerance, positive and negative aspects, secondary effects).|T4, immediately after the procedure before leaving the hydrotherapy room|Questionnaires for healthcare professionals present during the hydrotherapy session|||percentage of healthcare responses|questionnaires||Number
2552443|NCT02793947|Other Pre-specified|Number of Participants With Medication-related Side Effects|Patients will be monitored every 15 minutes in the recovery room and every 4 hours for the first two post-operative days by nursing personnel for medication side effects related to ropivacaine toxicity including blurred vision, hearing problems, transient peripheral paralysis, dizziness, convulsion, uncontrolled muscle contraction, hypotension, bradycardia, and new onset arrhythmia.|48 hours following surgery||||Participants|||Count of Participants
2552444|NCT02793947|Secondary|Total Narcotic Consumption|Parenteral and oral narcotic agents will be utilized by patients for post-operative pain control per the standard of care. No alterations in narcotic prescription behavior will be observed for this study.|Narcotic consumption will be recorded every 8 hours for the first two post-operative days.||||mg of morphine||Inter-Quartile Range|Mean
2552445|NCT02793947|Primary|Visual Analog Scale Pain Assessment|"Patients will describe their current level of comfort on a 10 point scale while at rest. Zero corresponds to no pain and ten corresponds to the most extreme possible pain. Visual analog scores will be collected by nursing staff who are blinded to the treatment allocation."|Pain assessment will be collected immediately prior to surgery (pre-op), immediately following surgery in the post-anesthesia care unit (PACU), and every 4 hours following surgery for the first two post-operative days (48 hours total; 4H-48H)||||units on a scale||Inter-Quartile Range|Median
2552446|NCT02793817|Post-Hoc|Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 15|"The difference in mean changes from BL in AC cell count grade at Day 15 for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID.~Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better.~Anterior Chamber Cells 0 = No cells seen~= 1 - 5 cells~= 6 - 15 cells~= 16 - 30 cells~= greater than 30 cells"|Visit 1 (Baseline) and Visit 6 (Day 15)|Intent to Treat - All subjects randomized|||score on a scale||Standard Deviation|Mean
2552447|NCT02793817|Post-Hoc|Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 8|"The difference in mean changes from BL in AC cell count grade at Day 8 for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID.~Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better.~Anterior Chamber Cells 0 = No cells seen~= 1 - 5 cells~= 6 - 15 cells~= 16 - 30 cells~= greater than 30 cells"|Visit 1 (Baseline) and Visit 5 (Day 8)|Intent to Treat - All subjects randomized|||score on a scale||Standard Deviation|Mean
2552448|NCT02793817|Secondary|Change From Baseline (BL) Anterior Chamber (AC) Cells at Day 4|"The difference in mean changes from BL in AC cell count grade at Day 4 for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID.~Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better.~Anterior Chamber Cells 0 = No cells seen~= 1 - 5 cells~= 6 - 15 cells~= 16 - 30 cells~= greater than 30 cells"|Visit 1 (Baseline) and Visit 4 (Day 4)|Intent to Treat - All subjects randomized|||score on a scale||Standard Deviation|Mean
2552449|NCT02793817|Secondary|Complete Resolution of Anterior Chamber (AC) Flare at Day 4|"Number and percentage of subjects with complete resolution of AC flare in the surgical eye (study eye) at Day 4 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID.~Investigators were asked to grade AC flare based on the following scale wherein higher scores indicate a higher degree of flare present and a decrease across time indicates the condition is getting better.~Anterior Chamber Flare 0 = None~= Mild (trace to clearly noticeable, visible)~= Moderate (without plastic aqueous humor)~= Marked (with plastic aqueous humor)~= Severe (with fibrin deposits and/or clots)"|Visit 4 (Day 4) maintained through Visit 6 (Day 15)|Intent to Treat - All subjects randomized|||Participants|||Count of Participants
2552450|NCT02793817|Secondary|Complete Resolution of Ocular Pain at Day 4|"Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 4 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID.~Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain at Days 1, 4, 8, 15, and the follow-up visit between Days 17 and 19. Higher scores were worse outcomes.~The following scoring scale was used for ocular pain:~0 = None~= Minimal~= Mild~= Moderate~= Moderately Severe~= Severe"|Visit 4 (Day 4) maintained through Visit 6 (Day 15)|Intent to Treat - All subjects randomized|||Participants|||Count of Participants
2552451|NCT02793817|Primary|Complete Resolution of Ocular Pain at Day 8|"Number and percentage of subjects with complete resolution of ocular pain in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID.~Subjects were given the Subject-Rated Ocular Pain Assessment to subjectively rate their pain at Days 1, 4, 8, 15, and the follow-up visit between Days 17 and 19. Higher scores were worse outcomes.~The following scoring scale was used for ocular pain:~0 = None~= Minimal~= Mild~= Moderate~= Moderately Severe~= Severe"|Visit 5 (Day 8) maintained through Visit 6 (Day 15)|Intent to Treat - All subjects randomized|||Participants|||Count of Participants
2552452|NCT02793817|Primary|Complete Resolution of Anterior Chamber (AC) Cells at Day 8|"Number and percentage of subjects with complete resolution of AC cells in the surgical eye (study eye) at Day 8 maintained through Day 15, without receiving rescue medication prior to Day 15, for KPI-121 1% dosed twice daily (BID) compared with vehicle dosed BID.~Investigators were asked to grade AC cell based on the following scale wherein higher scores indicate a higher degree of cells present and a decrease across time indicates the condition is getting better.~Anterior Chamber Cells 0 = No cells seen~= 1 - 5 cells~= 6 - 15 cells~= 16 - 30 cells~= greater than 30 cells"|Visit 5 (Day 8) maintained through Visit 6 (Day 15)|Intent to Treat - All subjects randomized|||Participants|||Count of Participants
2552453|NCT02793674|Secondary|Maximum Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Weight-Stratified Subgroups on Both Types of HFNC Delivery System (FP and VT)|"Exploratory analysis of patients by further stratified weight groupings (<5 kg, 5-8 kg, and >8 kg) was performed to determine the greatest observed benefit of HFNC flow titration in patients of different sizes. For this outcome, the maximum percent change in PRP was obtained for all titrations on both types of HFNC delivery system (FP and VT).~It was not pre-specified to compare the two different HFNC delivery systems."|median of the maximum percent change in PRP over a 5 minute period|For this outcome measure, the arms/groups were combined to include all patients enrolled in the study. This included the patients studied on FP only (n=9) and those studied on VT and FP both (n=12) for a total n=21.|||percent||Inter-Quartile Range|Median
2552454|NCT02793674|Secondary|Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Weight-Stratified Subgroups on Both Types of HFNC Delivery System (FP and VT)|"To assess the relationship between patient size and dose-response of HFNC flow rate, we compared subgroups stratified by weight (patients <8 kg and >8 kg). For this outcome, the median percent change in PRP was obtained for all titrations on both types of HFNC delivery system (FP and VT).~It was not pre-specified to compare the two different HFNC delivery systems."|medain percent change in PRP over a 5 minute period|For this outcome measure, the arms/groups were combined to include all patients enrolled in the study. This included the patients studied on FP only (n=9) and those studied on VT and FP both (n=12) for a total n=21.|||percent change in PRP from baseline||Inter-Quartile Range|Median
2552527|NCT02793154|Primary|Part A: Presence RBC and WBC in Urine Assessed by Microscopy|"Samples were collected to analyze the presence of RBC and WBC in urine by microscopy. Individual Par. data at indicated time point has been presented. NA indicates data was not available as RBC and WBC count would only available if blood or protein were abnormal. The RBC and WBC values of 1 for participant 1 actually reflect 0-1."|Day 5|All Subjects Population|||High Power field|||Number
2552455|NCT02793674|Secondary|Percent Change in Pressure-rate Product (PRP) From Baseline as a Function of Increasing HFNC Flow Rate, Comparing Different HFNC Delivery Systems|For this outcome, a subgroup of patients (N=12) were examined who had PRP measurements obtained on two different HFNC delivery systems (Fisher & Paykel (FP) and Vapotherm (VT)) in back-to-back flow titration periods. With one exception, patients were first studied on the FP and then transitioned to the VT HFNC delivery system.|median PRP over a 5 minute period|Percent change in PRP from baseline (of 0.5 L/kg/min) was measured at different flow rates (1.0, 1.5, and 2.0 L/kg/min) for patients who had flow titrations done on the two different HFNC delivery systems (Fisher & Paykel (FP) and Vapotherm (VT)).|||percent change in PRP||Inter-Quartile Range|Median
2552456|NCT02793674|Secondary|Phase Angle as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)|"Phase angle is a measure of asynchrony between thoracic and abdominal breathing compartments that has correlated with increased effort of breathing. It is derived by measuring the relative expansion of these two breathing compartments and describing the synchrony between them as an angle (theta). For this outcome, the phase angle was obtained for all titrations on both types of HFNC delivery system (FP and VT).~It was not pre-specified to compare the two different HFNC delivery systems."|median phase angle over a 5 minute period|For this outcome measure, the arms/groups were combined to include all patients enrolled in the study. This included the patients studied on FP only (n=9) and those studied on VT and FP both (n=12) for a total n=21.|||degrees||Inter-Quartile Range|Median
2552457|NCT02793674|Secondary|Pressure-rate Product (PRP) as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)|"PRP is a validated objective metric of effort of breathing which is derived from the product of the peak-to-trough change in esophageal pressure (in cmH20) and the respiratory rate (breaths per minute). These values were obtained from 5 minute flow titration periods. For this outcome, the PRP was obtained for all titrations on both types of HFNC delivery system (FP and VT).~It was not pre-specified to compare the two different HFNC delivery systems."|median PRP over a 5 minute period|For this outcome measure, the arms/groups were combined to include all patients enrolled in the study. This included the patients studied on FP only (n=9) and those studied on VT and FP both (n=12) for a total n=21.|||cmH20 * breaths/minute||Inter-Quartile Range|Median
2552458|NCT02793674|Primary|Percent Change in Pressure-rate Product (PRP) as a Function of Increasing HFNC Flow Rate on Both Types of HFNC Delivery System (FP and VT)|"PRP is a validated objective metric of effort of breathing which is derived from the product of the peak-to-trough change in esophageal pressure (in cmH20) and the respiratory rate (breaths per minute).~The percent change in PRP is derived from the quotient of the absolute PRP at increased HFNC flow rates (1.0, 1.5, and 2.0 L/kg/min) divided by the absolute PRP at a baseline HFNC flow rate (0.5 L/kg/min). Percent change in PRP was used because a) there was a large degree of heterogeneity in baseline absolute PRP values in our study population based upon patient size, disease severity, and time point of illness, and b) we allowed for repeated measures on the same patient which would bias absolute PRP values in favor of those who were measured more frequently.~It was not pre-specified to compare the two different HFNC delivery systems."|median percent change in PRP over 5 minute measurement period|For this outcome measure, the arms/groups were combined to include all patients enrolled in the study. This included the patients studied on FP only (n=9) and those studied on VT and FP both (n=12) for a total n=21.|||percent change in PRP||Inter-Quartile Range|Median
2552459|NCT02793232|Secondary|Part B: Percent Change From Baseline in Cerebrospinal Spinal Fluid (CSF) Amyloid Beta (ABeta) Fragments|ABeta is the peptide fragment of the amyloid precursor protein. Percent change from baseline in CSF concentration of ABeta fragments (ABeta 1-38, ABeta 1-40, ABeta 1-42, ABeta total, ABeta x-38, ABeta x-40, ABeta x-42, soluble amyloid precursor protein alpha (sAPP-alpha), soluble amyloid precursor protein beta (sAPP-beta) at Day 14 was reported in this outcome measure.|Baseline, Day 14|Pharmacodynamic CSF concentration population: all enrolled and treated participants who had at least 1 measureable CSF ABeta concentration. Number of participants analyzed= participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be analyzed for Part A and C, as pre specified in protocol.|||percent change||Standard Error|Mean
2552460|NCT02793232|Secondary|Part B: Renal Clearance of PF-06751979|Renal clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated in urine. It was calculated as amount of drug excreted unchanged in urine during the dosing interval tau (Aetau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours.|0-24 hours on Day 14|PK parameter analysis set =all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.Here, number of participants analyzed =participants who were evaluable for this outcome measure.Data for this outcome measure was not planned to be analyzed for Part A and C,as pre specified in protocol.|||milliliter per minute||Geometric Coefficient of Variation|Geometric Mean
2552461|NCT02793232|Secondary|Part B: Percentage of Dose of PF-06751979 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%)|Aetau% was calculated as: 100*Aetau/dose. Aetau was the amount of drug excreted unchanged in urine during the dosing interval tau, where tau was 24 hours.|0-24 hours on Day 14|PK parameter analysis set =all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.Here, number of participants analyzed =participants who were evaluable for this outcome measure.Data for this outcome measure was not planned to be analyzed for Part A and C,as pre specified in protocol.|||percentage of dose excreated||Geometric Coefficient of Variation|Geometric Mean
2552462|NCT02793232|Secondary|Part B: Amount of PF-06751979 Excreted Unchanged in Urine Over the Dosing Interval Tau (Aetau)|Aetau was the amount of drug excreted unchanged in urine during the dosing interval tau, where tau was 24 hours.|0-24 hours on Day 14|PK parameter analysis set =all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.Here, number of participants analyzed =participants who were evaluable for this outcome measure.Data for this outcome measure was not planned to be analyzed for Part A and C,as pre specified in protocol.|||milligram||Geometric Coefficient of Variation|Geometric Mean
2552537|NCT02793154|Primary|Part A: Hemoglobin Level at Indicated Time Points|Blood samples were collected for analysis of hemoglobin level. Individual Par. data at indicated time point has been presented.|Day 5|All Subjects Population|||Grams per liter|||Number
2552538|NCT02793154|Primary|Part A: Red Blood Cell (RBC) Count at Indicated Time Points|Blood samples were collected for analysis of RBC count. Individual Par. data at indicated time point has been presented.|Day 5|All Subjects Population|||Tetra unit per liter|||Number
2552463|NCT02793232|Secondary|Part C: Apparent Volume of Distribution (Vz/F) of PF-06751979|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2552464|NCT02793232|Secondary|Part C: Plasma Decay Half-Life (t1/2) of PF-06751979|Plasma decay half-life was the time duration for the plasma concentration to decrease by one-half of its original concentration.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.|||hours||Standard Deviation|Mean
2552465|NCT02793232|Secondary|Part C: Observed Accumulation Ratio for Maximum Observed Plasma Concentration (Rac Cmax) of PF-06751979|Rac for Cmax on Day 14 was calculated as: Cmax on Day 14 divided by Cmax on Day 1, where Cmax was the maximum observed plasma concentration.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2552466|NCT02793232|Secondary|Part C: Observed Accumulation Ratio (Rac) for AUCtau of PF-06751979|Rac for AUCtau at Day 14 was calculated as: AUCtau on Day 14 divided by AUCtau on Day 1.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2552467|NCT02793232|Secondary|Part C: Peak-to-Trough Ratio of PF-06751979|Peak-to-trough ratio was calculated by dividing Cmax with Cmin of PF-06751979. Cmax was maximum plasma concentration during the dosing interval and Cmin was minimum observed plasma concentration during the dosing interval.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2552468|NCT02793232|Secondary|Part C: Minimum Observed Plasma Concentration (Cmin) of PF-06751979|Minimum observed concentration during the dosing interval.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2552469|NCT02793232|Secondary|Part C: Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.|||milliliter per minute||Geometric Coefficient of Variation|Geometric Mean
2552470|NCT02793232|Secondary|Part C: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval Tau (AUCtau[dn]) of PF-06751979|Area under the concentration curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours. AUCtau (dn) was calculated by dividing AUCtau by the exact dose of PF-06751979 (in mg) administered to a participant.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||(nanogram*hour/milliliter)/milligram||Geometric Coefficient of Variation|Geometric Mean
2552471|NCT02793232|Secondary|Part C: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06751979|Cmax(dn) was obtained calculated by dividing Cmax by the exact dose of PF-06751979 (in mg) administered to a participant.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.|||(nanogram per milliliter) per milligram||Geometric Coefficient of Variation|Geometric Mean
2552472|NCT02793232|Secondary|Part C: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979||pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.|||hours||Full Range|Median
2552473|NCT02793232|Secondary|Part C: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06751979|Area under the plasma concentration versus time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2552474|NCT02793232|Secondary|Part C: Maximum Observed Plasma Concentration (Cmax) of PF-06751979||pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2552475|NCT02793232|Secondary|Part B: Apparent Volume of Distribution (Vz/F) of PF-06751979|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2552476|NCT02793232|Secondary|Part B: Plasma Decay Half-Life (t1/2) of PF-06751979|Plasma decay half-life is the time duration for the plasma concentration of PF-06751979 to decrease by one-half of its original concentration.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||hour||Standard Deviation|Mean
2552477|NCT02793232|Secondary|Part B: Observed Accumulation Ratio for Maximum Observed Plasma Concentration (Rac Cmax) of PF-06751979|Rac for Cmax on Day 7 was calculated as: Cmax on Day 7 divided by Cmax on Day 1 and Rac for Cmax on Day 14 was calculated as: Cmax on Day 14 divided by Cmax on Day 1, where Cmax was the maximum observed plasma concentration.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2552478|NCT02793232|Secondary|Part B: Observed Accumulation Ratio (Rac) for AUCtau of PF-06751979|Rac for AUCtau for Day 7 was calculated as: AUCtau on Day 7 divided by AUCtau on Day 1. Rac for AUCtau for Day 14 was calculated as: AUCtau on Day 14 divided by AUCtau on Day 1.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14|Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2552479|NCT02793232|Secondary|Part B: Peak-to-Trough Ratio of PF-06751979|Peak-to-trough ratio was calculated by dividing Cmax with Cmin of PF-06751979. Cmax was maximum plasma concentration during the dosing interval and Cmin was minimum observed plasma concentration during the dosing interval.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2552480|NCT02793232|Secondary|Part B: Minimum Observed Plasma Concentration (Cmin) of PF-06751979||pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2552481|NCT02793232|Secondary|Part B: Apparent Clearance (CL/F) of PF-06751979|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time point for each arm.|||milliliter per minute||Geometric Coefficient of Variation|Geometric Mean
2552482|NCT02793232|Secondary|Part B: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval Tau (AUCtau[dn]) of PF-06751979|Area under the concentration curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours. AUCtau (dn) was calculated by dividing AUCtau by the exact dose of PF-06751979 (in mg) administered to a participant.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14|Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||(nanogram*hour/milliliter)/milligram||Geometric Coefficient of Variation|Geometric Mean
2552483|NCT02793232|Secondary|Part B: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06751979|Cmax(dn) was obtained calculated by dividing Cmax by the exact dose of PF-06751979 (in mg) administered to a participant.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time point for each arm.|||(nanogram per milliliter) per milligram||Geometric Coefficient of Variation|Geometric Mean
2552484|NCT02793232|Secondary|Part B: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979||pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time point for each arm.|||hours||Full Range|Median
2554045|NCT02764190|Primary|Sleep|Adolescent self-reported hours of sleep on a typical night in the past 3 months. The sleep scale includes 13 values: 0 (min) to 12+ (max) hours of sleep per night. Higher scores mean a better outcome.|3 month||||score on a scale||Standard Deviation|Mean
2552485|NCT02793232|Secondary|Part B: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06751979|Area under the plasma concentration versus time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14|Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2552486|NCT02793232|Secondary|Part B: Maximum Observed Plasma Concentration (Cmax) of PF-06751979||pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time points for each arm.|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2552487|NCT02793232|Secondary|Part A: Apparent Volume of Distribution (Vz/F) of PF-06751979|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2552488|NCT02793232|Secondary|Part A: Apparent Clearance (CL/F) of PF-06751979|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.|||milliliter per minute||Geometric Coefficient of Variation|Geometric Mean
2552489|NCT02793232|Secondary|Part A: Plasma Decay Half-Life (t1/2) of PF-06751979|Plasma decay half-life is the time duration for the plasma concentration of PF-06751979 to decrease by one-half of its original concentration.|pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.|||hours||Standard Deviation|Mean
2552490|NCT02793232|Secondary|Part A: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979||pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.|||hours||Full Range|Median
2552491|NCT02793232|Secondary|Part A: Dose Normalized Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf [dn]) of PF-06751979|AUCinf (dn) was calculated by dividing AUCinf by the exact dose of PF-06751979 (in mg) administered to a participant. AUCinf was area under the plasma concentration-time profile from time zero extrapolated to infinite time (0-inf).|pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.|||(nanogram*hour/milliliter) per milligram||Geometric Coefficient of Variation|Geometric Mean
2552492|NCT02793232|Secondary|Part A: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of PF-06751979|AUClast(dn) was calculated by dividing AUClast by the exact dose of PF-06751979 (in mg) administered to a participant. AUClast was area under the plasma concentration-time profile from time zero to the time of last measured concentration.|pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.|||(nanogram*hour/milliliter) per milligram||Geometric Coefficient of Variation|Geometric Mean
2552493|NCT02793232|Secondary|Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06751979|Cmax(dn) was obtained calculated by dividing Cmax by the exact dose of PF-06751979 (in milligram) administered to a participant.|pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.|||(nanogram per milliliter) per milligram||Geometric Coefficient of Variation|Geometric Mean
2552494|NCT02793232|Secondary|Part A: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06751979|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).|pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2552495|NCT02793232|Secondary|Part A: Area Under the Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of PF-06751979|Area under the plasma concentration-time profile from time zero to the time of last measured concentration (AUClast).|pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1|PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2552496|NCT02793232|Secondary|Part A: Maximum Observed Plasma Concentration (Cmax) of PF-06751979||pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1|Pharmacokinetic (PK) parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2552497|NCT02793232|Primary|Number of Participants With Laboratory Abnormalities|Abnormalities criteria:hematology(hemoglobin; hematocrit; RBC<0.8*lower limit of normal [LLN]; platelets<0.5*LLN,>1.75*upper limit of normal [ULN]; WBC<0.6*LLN,>1.5*ULN; lymphocytes; neutrophils; basophils; eosinophils; monocytes<0.8*LLN,>1.2*ULN; coagulation(prothrombin ratio>1.1*ULN), liver(bilirubin>1.5*ULN; aspartate aminotransferase; alanine aminotransferase; alkaline phosphatase; gamma GT>0.3*ULN; protein; albumin<0.8*LLN,>1.2*ULN); renal(blood urea nitrogen, creatinine>1.3*ULN; uric acid>1.2*ULN); electrolytes(sodium<0.95*LLN,>1.05*ULN; potassium; chloride; calcium; bicarbonate<0.9*LLN,>1.1*ULN), chemistry(glucose<0.6*LLN,>1.5* ULN); urinalysis(pH <4.5,>8; glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte, esterase>1; WBC; bacteria>=20, epithelial cells>=6; granular casts, hyaline casts, red cell casts, white cell casts>1; lipids(cholesterol[C], LDL-C>1.3*ULN; HDL-C<0.8*LLN, triglycerides>1.3*ULN); hormones(T4, T3, T4, TSH<0.8*LLN,>1.2*ULN).|Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2552498|NCT02793232|Primary|Number of Participants With Vital Sign Abnormalities|Criteria for vital signs abnormalities: systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), diastolic blood pressure (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm). Maximum IFB in Supine SBP >=30 mmHg, Maximum decrease from baseline (DFB) in Supine SBP >=30 mmHg, maximum DFB in Supine DBP >=20 mmHg.|Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2552499|NCT02793232|Primary|Part A: Number of Participants With Cardiac Rhythms of Potential Clinical Concern Assessed By Telemetry|In all Periods of Part A, continuous cardiac monitoring was maintained for 8 hours (or longer if considered clinically necessary by the investigator) following dose administration on Day 1. All abnormal cardiac rhythms were recorded and reviewed by the study physician for the presence of rhythms of potential clinical concern.|Day 1|Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.|||participants|||Number
2552500|NCT02793232|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Criteria for abnormal values of ECG parameters: maximum pulse rate (PR) interval greater than or equal to (>=)300 milliseconds (msec); maximum PR interval increase from baseline (IFB): >=25 percent (%) when baseline was greater than (>)200 msec; or >=50 % when baseline was greater than (>)200 msec, maximum QRS interval >=140 msec and QRS interval IFB: >=50%. QT interval using Fridericia's correction (QTcF) ranges from 450 msec to maximum less than (<)480 msec, less than or equal to (<=) 480 msec to maximum <500 msec and maximum >=500 msec, maximum QTcF interval IFB range from <=30 to <60 msec and maximum >=60 msec. Only categories which included at least 1 participant with abnormality are reported in this outcome measure.|Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2552501|NCT02793232|Primary|Part B and C: Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) at Day 19|"C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of Yes on actual attempt); preparatory acts toward imminent suicidal behavior (Yes on preparatory acts or behavior, aborted attempt or interrupted attempt), suicidal ideation (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent). In this outcome measure, number of participants with positive response (response of yes) to suicidal behavior, ideation or any non-suicidal self-injurious behavior, at Day 19 were reported."|Day 19|Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre-specified in protocol.|||participants|||Number
2552502|NCT02793232|Primary|Part B and C: Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) at Day 14|"C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of Yes on actual attempt); preparatory acts toward imminent suicidal behavior (Yes on preparatory acts or behavior, aborted attempt or interrupted attempt), suicidal ideation (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent). In this outcome measure, number of participants with positive response (response of yes) to suicidal behavior, ideation or any non-suicidal self-injurious behavior, at Day 14 were reported."|Day 14|Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre-specified in protocol.|||participants|||Number
2552503|NCT02793232|Primary|Part B and C: Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) at Day 7|"C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of Yes on actual attempt); preparatory acts toward imminent suicidal behavior (Yes on preparatory acts or behavior, aborted attempt or interrupted attempt), suicidal ideation (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent). In this outcome measure, number of participants with positive response (response of yes) to suicidal behavior, ideation or any non-suicidal self-injurious behavior, at Day 7 were reported."|Day 7|Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre-specified in protocol.|||participants|||Number
2552528|NCT02793154|Primary|Part A: Number of Par. With Presence of Ketones, Occult Blood, Glucose, Nitrates and Leukocyte Esterase in Urine at Indicated Time Points|Urine samples were collected to analyze presence of ketones, occult blood, glucose, nitrates and leukocyte esterase in urine. The dipstick test gives results in a semi-quantitative manner. NA represents data was not available due to lab data transfer error. Individual Par. data at indicated time point has been presented.|Day 5|All Subjects Population|||Participants|||Number
2552504|NCT02793232|Primary|Part B and C: Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline|"C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of Yes on actual attempt); preparatory acts toward imminent suicidal behavior (Yes on preparatory acts or behavior, aborted attempt or interrupted attempt), suicidal ideation (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent). In this outcome measure, number of participants with positive response (response of yes) to suicidal behavior, ideation or any non-suicidal self-injurious behavior, at baseline were reported."|Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre-specified in protocol.|||participants|||Number
2552505|NCT02793232|Primary|Number of Participants With Abnormal Neurological Examinations Findings|The neurological examination included the assessment of higher cortical function, the cranial nerves, motor function, deep tendon reflexes, sensory exam, and coordination and gait. Abnormality in neurological examinations was based on investigator's discretion.|Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2552506|NCT02793232|Primary|Number of Participants With Abnormal Physical Examinations Findings|Full physical examination included head, ears, eyes, nose, mouth, skin, heart, lung, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Abnormality in physical examinations was based on investigator's discretion.|Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2552507|NCT02793232|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent were events between first dose of study drug and up to the follow up visit (up to 36 days in Part A, 49 days in Part B and C), that were absent before treatment or that worsened relative to pretreatment state.|Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2552508|NCT02793154|Secondary|Part B: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD|GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: nausea/vomiting, fullness/early satiety, and bloating. The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 12 weeks|All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
2552509|NCT02793154|Secondary|Part B: Assessment of GCSI-DD Score|GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: nausea/vomiting, fullness/early satiety, and bloating. GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Par. rate each symptom on a 6-point scale from 0 (none), 1 (very mild), 2 (mild), 3 (moderate), 4 (severe) to 5 (very severe). This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
2552510|NCT02793154|Secondary|Part B: Number of Par. With AEs and SAEs|An AE is any untoward medical occurrence in a clinical investigation Par., temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 12 weeks|All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
2552511|NCT02793154|Secondary|Part B: Number of Par. With Abnormal Values for Urinalysis|Urinalysis included analysis of concentration of creatinine, presence of ketones and occult blood in urine (using dipstick test), presence RBC and WBC in urine (using microscopy), specific gravity and pH of urine. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
2552512|NCT02793154|Secondary|Part B: Number of Par. With Abnormal Values for Clinical Chemistry Parameters|Clinical chemistry parameters included ALT, AST, GGT, glucose, calcium, magnesium, potassium, sodium, phosphorus inorganic, chloride, BUN, creatinine, direct bilirubin, total bilirubin, indirect bilirubin, glomerular filtration rate (MDRD Enzymatic level), total protein, and albumin level. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
2552513|NCT02793154|Secondary|Part B: Number of Par. With Abnormal Values for Hematology Parameters|Hematology parameters included basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils, WBC, RBC, hemoglobin and hematocrit levels. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
2552514|NCT02793154|Secondary|Part B: Number of Par. With Abnormal Values for Vital Signs|Vital signs included SBP, DBP and heart rate. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 12 weeks|All Subjects Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
2552515|NCT02793154|Secondary|Part B: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score|EGG with WLT is a standardized test to induce gastric distention and collect VAS of upper gastrointestinal symptoms ranging from stomach empty (0) to stomach full (100), hunger (0) to satiety (100) and no bloating (0) to severe bloating (100). The gastric distention produced by the WL induces upper gastrointestinal symptoms including stomach fullness, hunger, bloating and abdominal pain in Par. allowing the assessment of gastric myoelectrical activity. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
2552516|NCT02793154|Secondary|Part B: The Volume of Water Ingested During EGG|EGG with WLT is a standardized test to induce gastric distention. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
2552517|NCT02793154|Secondary|Part B: Rate of [13]C Dose Excreted in Breath|The rate of [13]C dose excreted in breath was assessed to study gastric empting using GEBT. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
2552518|NCT02793154|Secondary|Part B: Time to Half-gastric Emptying|The GEBT containing 13C-Spirulina was used to measure the time to half-gastric emptying. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
2552519|NCT02793154|Primary|Part B: Assessment of Nausea by VAS Score|The VAS was used to measure the intensity of nausea analyzed on the basis of scores ranging from 0 (no nausea) to 100 (severe nausea). This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
2552520|NCT02793154|Primary|Part B: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal|EGG is a technique used to assess gastric myoelectrical activity using WLT. An EGG with An WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
2552521|NCT02793154|Primary|Part B: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region|EGG is a technique used to assess gastric myoelectrical activity using WLT. An EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
2552522|NCT02793154|Primary|Part B: Distribution of Average Power by Frequency Region|EGG is a technique used to assess gastric myoelectrical activity using WLT. An EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. This analysis was planned but not performed for Part B as the study was terminated during Part A.|Up to 8 weeks|Pharmacodynamic Population. The data were not collected for Part B because no Par. were enrolled into this part of the study.||||||
2552523|NCT02793154|Primary|Part A: Number of Par. With Nausea AEs Presenting Outside the Timing of the WLT and GCSI-DD|GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: nausea/vomiting, fullness/early satiety, and bloating. The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT.|Up to 12 days|All Subjects Population.|||Participants|||Number
2552524|NCT02793154|Primary|Part A: Number of Par. With Adverse Events (AEs) and Serious AEs (SAEs)|An AE is any untoward medical occurrence in a clinical investigation Par. temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. Number of Par. with AEs and SAEs have been presented.|Up to 12 days|All Subjects Population|||Participants|||Number
2552525|NCT02793154|Primary|Part A: Potential of Hydrogen (pH) of Urine at Indicated Time Points|Urine Samples were collected to analyze pH. pH is a measure of hydrogen ion concentration and used to determine the acidity or alkalinity of urine. pH scale ranges from 0 to 14. A neutral pH is 7.0. The higher number indicates the more basic (alkaline) nature of urine and lower the number indicates the more acidic urine.Individual Par. data at indicated time point has been presented.|Day 5|All Subjects Population|||Points on a scale|||Number
2552526|NCT02793154|Primary|Part A: Specific Gravity of Urine at Indicated Time Points|Urine samples were collected to analyze specific gravity of urine. Specific gravity, is a measure of urine concentration and is measured using a chemical test. Specific gravity measurements provide a comparison of the amount of substances dissolved in urine as compared to pure water. If there were no solutes present, the specific gravity of urine would be 1.000 the same as pure water. Specific gravity between 1.002 and 1.035 could be considered as normal. Individual Par. data at indicated time point has been presented.|Day 5|All Subjects Population|||Kilograms per meter^3|||Number
2552529|NCT02793154|Primary|Part A: Concentration of Creatinine in Urine at Indicated Time Points|Samples were collected to analyze concentration of creatinine in urine. Individual Par. at indicated time point has been presented at indicated time points.|Day 5|All Subjects Population|||Micromoles per liter|||Number
2552539|NCT02793154|Primary|Part A: Basophils, Eosinophil, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, White Blood Cell (WBC) Level at Indicated Time Points|Blood samples were collected for analysis of hematology parameters including basophils, eosinophil, lymphocytes, monocytes, platelet count, total neutrophils, and WBC. Individual Par. data at indicated time point has been presented.|Day 5|All Subjects Population|||Giga unit per liter|||Number
2552540|NCT02793154|Primary|Part A: Assessment of Heart Rate (HR) as a Measure of Safety|HR was measured either in a semi-recumbent or seated position after at least a 5-minute rest period. Individual Par. data for HR up to follow-up (up to 12 days) has been presented.|Up to 12 days|All Subjects Population|||Beats per minute|||Number
2552541|NCT02793154|Primary|Part A: Assessment of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) as a Measure of Safety|SBP and DBP was measured either in a semi-recumbent or seated position after at least a 5-minute rest period. Individual Par. data for SBP and DBP up to follow-up (up to 12 days) has been presented.|Up to 12 days|All Subjects Population|||Millimeter of mercury|||Number
2552542|NCT02793154|Primary|Part A: Assessment of Stomach Fullness, Hunger, Bloating and Abdominal Pain by VAS Score|The effect of exenatide on gastric myoelectrical activity was evaluated using EGG with WLT. An EGG with WLT is a standardized test to induce gastric distention and collect VAS of upper gastrointestinal symptoms. The gastric distention produced by the WL induces upper gastrointestinal symptoms including stomach fullness, hunger, bloating and abdominal pain in Par. allowing the assessment of gastric myoelectrical activity. The intensity of upper gastrointestinal symptoms was measured using VAS scores ranging from stomach empty (0) to stomach full (100), hunger (0) to satiety (100) and no bloating (0) to severe bloating (100). Individual Par. responses to VAS has been presented.|Day 4|Pharmacodynamic Population|||Scores on VAS scale|||Number
2552543|NCT02793154|Primary|Part A: The Volume of Water Ingested During EGG|The volume of water consumed by Par. at indicated time points after treatment with exenatide during EGG with WLT was determined. An EGG with WLT is a standardized test to induce gastric distention. Individual Par. data has been presented.|Up to Day 4|Pharmacodynamic Population|||Milliliter|||Number
2552544|NCT02793154|Primary|Part A: Gastroparesis Cardinal Symptom Index -Daily Diary (GCSI-DD) Score|GCSI-DD is a questionnaire of gastroparesis symptom severity covering the following domains: episodes (epi) of vomiting, epi of retching, nausea/vomiting, fullness/early satiety, and bloating. GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Par. rate each symptom on a 6-point scale from 0 (none), 1 (very mild), 2 (mild), 3 (moderate), 4 (severe),to 5 (very severe). Individual Par. data has been presented. All Subjects Population was used which consisted of all Par. who received at least one dose of study medication.|Up to Day 5|All Subjects Population|||Scores on GCSI-DD scale|||Number
2552545|NCT02793154|Primary|Part A: Rate of [13]C Dose Excreted in Breath|The effect of exenatide on gastric emptying was be assessed by calculating the percent dose excreted of 13C in breath multiplied by 1000 (kPCD). Breath samples were collected at the indicated time points. Individual Par. data at pre-meal and 45, 90, 120, 150, 180 and 240 minutes post-meal has been presented.|Day 5|Pharmacodynamic Population|||kPCD per minute|||Number
2552546|NCT02793154|Primary|Part A: Time to Half-gastric Emptying|Breath samples were collected to assess the time to half gastric emptying using gastric emptying breath test (GEBT) containing 13 Carbon (13C)-Spirulina pre-meal and post GEBT meal. The GEBT method was used to measure GE of solid food. The time to half gastric emptying for individual Par. has been presented.|Up to Day 5|Pharmacodynamic Population|||Minutes|||Number
2552547|NCT02793154|Primary|Part A: Assessment of Nausea by Visual Analogue Scale (VAS) Score|The effect of exenatide on gastric myoelectrical activity was evaluated using EGG with WLT. An EGG with WLT is a standardized test to induce gastric distention and collect VAS of upper gastrointestinal symptoms. The gastric distention produced by the WL induces nausea in Par. allowing the assessment of gastric myoelectrical activity during the episodes of nausea. The intensity of upper gastrointestinal symptom of nausea was measured using VAS ranging from 0 (no nausea) to 100 (severe nausea) immediately before (pre-WL) and 10, 20, 30 minutes post-WL. Individual Par. responses to VAS score scale has been presented.|Day 4|Pharmacodynamic Population|||Scores on a scale|||Number
2552548|NCT02793154|Primary|Part A: Average Dominant Frequency|The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. An EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for average dominant frequency in the bradygastria, normal, tachygastria and duodenal range after treatment with exenatide at Pre-WL and 10, 20, 30 minutes post-WL has been presented.|Up to Day 4|Pharmacodynamic Population|||Cycles per minute|||Number
2552549|NCT02793154|Primary|Part A: Number Par. by Gastric Rhythm Status|EGG is a technique used to assess gastric myoelectrical activity and thereby gastric rhythm. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.|Up to 12 days|Pharmacodynamic Population. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.||||||
2552550|NCT02793154|Primary|Part A: Number of Par. With Shifts in Gastric Rhythm Status|EGG is a technique used to assess gastric myoelectrical activity and thereby gastric rhythm. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.|Up to 12 days|Pharmacodynamic Population. This analysis was planned as data dependent and not performed as the study was terminated early which resulted in few Par.||||||
2552551|NCT02793154|Primary|Part A: Percentage of Time With the Dominant EGG Frequencies in the Four Frequency Ranges of Bradygastria, Normal, Tachygastria and Duodenal|The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for dominant EGG frequencies including bradygastria, normal, tachygastria and duodenal at pre-WL and after treatment with exenatide at pre-WL and 10, 20, 30 minutes post-WL has been presented.|Up to Day 4|Pharmacodynamic Population|||Percentage of time|||Number
2552552|NCT02793154|Primary|Part A: Ratios of Average Power Post- WLT/Pre-WLT by Frequency Region|The effect of exenatide on gastric myoelectrical activity was assessed by EGG using WLT. EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for ratios of average power post- WLT/pre-WLT in the bradygastria, normal, tachygastria and duodenal range after treatment with exenatide at 10, 20, and 30 minutes post-WL has been presented.|Up to Day 4|Pharmacodynamic Population|||Ratio|||Number
2552553|NCT02793154|Primary|Part A: Distribution of Average Power by Frequency Region|The effect of exenatide on gastric myoelectrical activity was assessed by electrogastrogram (EGG) using water load test (WLT). EGG with WLT is a standardized test to induce gastric distention and measure myoelectrical responses. The gastric myoelectrical activity is generated by the pacemaker interstitial cells at a normal frequency of 3 cycles per minute. The shift of frequency from normal gastric myoelectrical activity to a slower rhythm is bradygastria or faster rhythm is tachygastria. Individual Par. data for distribution of average power in the bradygastria, normal, tachygastria and duodenal range during pre-WL and 10, 20 and 30 minutes post-WL after treatment with exenatide has been presented. The analysis was performed on Pharmacodynamic Population, which included all Par. who received at least one dose of study medication and had valid data.|Up to Day 4|Pharmacodynamic Population|||Percentage of power|||Number
2552554|NCT02792829|Secondary|Summary Scores for Palatability of Lenvatinib|"A hedonic Visual Analog Scale (VAS) was used to assess taste likability or palatability between a) lenvatinib suspension formulated with water versus the capsule formulation, b) a lenvatinib suspension formulated with with apple juice versus one formulated with water, and c) a lenvatinib suspension formulated with water administered 23 hours versus 2 hours after preparation. All participants selected one face based on flavor, smell, sweetness, acidity, saltiness, bitterness, and texture or mouth feel for each formulation they consumed. Each face had an associated score (1: Very Bad (angry face), 2: Bad (sad face), 3: Maybe Good or Maybe Bad (neutral face), 4: Good (smiling face), 5: Very Good (laughing face)). The VAS hedonic scale scores were summarized using descriptive statistics separately for each arm by formulation (Arm 1), number of capsules (2 vs 5 capsules) and preparation type (water vs apple juice) (Arm 2), and time of administration relative to preparation (Arm 3)."|Treatment Period 1, Day 1 (Visit 2); Treatment Period 2, Day 8 (Visit 8)|The Palatability Analysis Set was the group of subjects who received at least 1 dose of study drug and completed the visual analog scale (VAS) in at least one treatment period.|||Score on a scale||Full Range|Median
2552555|NCT02792829|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Lenvatinib|Safety assessment consisted on monitoring and recording all treatment-emergent adverse events (TEAEs) and SAEs; as well as laboratory evaluations for hematology, blood chemistry, and urine values; periodic measurement of vital signs, electrocardiograms (ECGs); and physical examinations. A TEAE was defined as an adverse events that: 1) emerged during treatment and up to 7 days from the last treatment, having been absent before treatment or at baseline, 2) reemerged during treatment, having been present at Baseline but stopped before treatment, or 3) worsened in severity during treatment relative to the state before treatment, when continuous.|From date of first dose of study treatment to date of last dose of study treatment, up to approximately 2 months 10 days|Safety Analysis Set was the group of subjects who received at least 1 dose of study drug and had at least 1 postdose safety assessment|||Participants|||Number
2552556|NCT02792829|Primary|Terminal Elimination Phase Half-life (t1/2)|Blood samples were collected during each Treatment Period at predose and at 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose. Plasma concentrations of lenvatinib were quantified by a high-performance LC-MS/MS method using a previously validated assay. The LLOQ was 0.25 ng/mL. Plasma PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of t1/2, which were then summarized as the median and full range for all participants and expressed in hours.|Treatment Period 1: Day 1 (Visit 2), Day 2 (Visit 3), Days 3 to 6 (Visits 4 to 7); Treatment Period 2: Day 8 (Visit 8), Day 9 (Visit 9), Days 10 to 13 (Visits 10 to 13)|PK analysis set|||Hours||Standard Deviation|Mean
2552557|NCT02792829|Primary|Time to Maximum Plasma Concentration (Tmax)|Blood samples were collected during each Treatment Period at predose and at 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose. Plasma concentrations of lenvatinib were quantified by a high-performance LC-MS/MS method using a previously validated assay. The LLOQ was 0.25 ng/mL. Plasma PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of tmax, which were then summarized as the median and full range for all participants and expressed in hours.|Treatment Period 1: Day 1 (Visit 2), Day 2 (Visit 3), Days 3 to 6 (Visits 4 to 7); Treatment Period 2: Day 8 (Visit 8), Day 9 (Visit 9), Days 10 to 13 (Visits 10 to 13)|PK analysis set|||Hours||Full Range|Median
2552558|NCT02792829|Primary|Time Prior to the First Measureable Concentration of Lenvatinib (Tlag)|Tlag was defined as the time delay between drug administration and the onset of drug absorption. Blood samples were collected during each Treatment Period at predose and at 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose. Plasma concentrations of lenvatinib were quantified by a high-performance LC-MS/MS method using a previously validated assay. The LLOQ was 0.25 ng/mL. Plasma PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of tlag, which were then summarized as the median and full range for all participants and expressed in hours.|Treatment Period 1: Day 1 (Visit 2), Day 2 (Visit 3), Days 3 to 6 (Visits 4 to 7); Treatment Period 2: Day 8 (Visit 8), Day 9 (Visit 9), Days 10 to 13 (Visits 10 to 13)|PK analysis set|||Hours||Full Range|Median
2552559|NCT02792829|Primary|Maximum Concentration (Cmax) of Lenvatinib in Plasma|Blood samples were collected during each Treatment Period at predose and at 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose. Plasma concentrations of lenvatinib were quantified by a high-performance LC-MS/MS method using a previously validated assay. The LLOQ was 0.25 ng/mL. Plasma PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Cmax, which were then summarized as the mean and standard deviation for all participants and expressed as nanograms/milliliter (ng/mL).|Treatment Period 1: Day 1 (Visit 2), Day 2 (Visit 3), Days 3 to 6 (Visits 4 to 7); Treatment Period 2: Day 8 (Visit 8), Day 9 (Visit 9), Days 10 to 13 (Visits 10 to 13)|Pharmacokinetic (PK) analysis set|||ng/mL||Standard Deviation|Mean
2552560|NCT02792829|Primary|Apparent Volume of Distribution (Vz/F)|Blood samples were collected during each Treatment Period at predose and at 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose. Plasma concentrations of lenvatinib were quantified by a high-performance LC-MS/MS method using a previously validated assay. The LLOQ was 0.25 ng/mL. Plasma PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates for the Vz/F, which were then summarized as the mean and standard deviation for all participants and expressed in liters (L).|Treatment Period 1: Day 1 (Visit 2), Day 2 (Visit 3), Days 3 to 6 (Visits 4 to 7); Treatment Period 2: Day 8 (Visit 8), Day 9 (Visit 9), Days 10 to 13 (Visits 10 to 13)|PK analysis set|||Liters||Standard Deviation|Mean
2552561|NCT02792829|Primary|Apparent Clearance (CL/F)|Blood samples were collected during each Treatment Period at predose and at 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose. Plasma concentrations of lenvatinib were quantified by a high-performance LC-MS/MS method using a previously validated assay. The LLOQ was 0.25 ng/mL. Plasma PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates for the CL/F, which were then summarized as the mean and standard deviation for all participants and expressed as liters/hour.|Treatment Period 1: Day 1 (Visit 2), Day 2 (Visit 3), Days 3 to 6 (Visits 4 to 7); Treatment Period 2: Day 8 (Visit 8), Day 9 (Visit 9), Days 10 to 13 (Visits 10 to 13)|PK analysis set|||L/hour||Standard Deviation|Mean
2552562|NCT02792829|Primary|Area Under the Plasma Concentration-Time Curve From Zero to 72 Hours (AUC(0-72))|Blood samples were collected during each Treatment Period at predose up to 72 hours postdose. Plasma concentrations of lenvatinib were quantified by a high-performance LC-MS/MS method using a previously validated assay. The LLOQ was 0.25 ng/mL. Plasma PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates for the AUC(0-72), which were then summarized as the mean and standard deviation for all participants and expressed as hr·ng/mL.|Treatment Period 1: Predose up to 72 hours postdose|PK analysis set|||hr·ng/mL||Standard Deviation|Mean
2552563|NCT02792829|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC(0-24))|Blood samples were collected during each Treatment Period at predose up to 24 hours post dose. Plasma concentrations of lenvatinib were quantified by a high-performance LC-MS/MS method using a previously validated assay. The LLOQ was 0.25 ng/mL. Plasma PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates for the AUC(0-24), which were then summarized as the mean and standard deviation for all participants and expressed as hr·ng/mL.|Treatment Period 1: Predose up to 24 hours post dose|PK analysis set|||h·ng/mL||Standard Deviation|Mean
2552564|NCT02792829|Primary|Area Under the Plasma Concentration-Time Curve From Zero to Infinity (AUC(0-inf))|Blood samples were collected during each Treatment Period at predose and at 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose. Plasma concentrations of lenvatinib were quantified by a high-performance LC-MS/MS method using a previously validated assay. The LLOQ was 0.25 ng/mL. Plasma PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates for the AUC(0-inf), which were then summarized as the mean and standard deviation for all participants and expressed as hr·ng/mL.|Treatment Period 1: Day 1 (Visit 2), Day 2 (Visit 3), Days 3 to 6 (Visits 4 to 7); Treatment Period 2: Day 8 (Visit 8), Day 9 (Visit 9), Days 10 to 13 (Visits 10 to 13)|PK analysis set|||hr·ng/mL||Standard Deviation|Mean
2552565|NCT02792829|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC(0-t))|Blood samples were collected during each Treatment Period at predose and at 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96, and 120 hours postdose. Plasma concentrations of lenvatinib were quantified by a high-performance liquid chromatography/tandem mass spectrometry (LC-MS/MS) method using a previously validated assay. The lower limit of quantitation (LLOQ) was 0.25 ng/mL. Plasma pharmacokinetics (PK) data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of AUC(0-t), which were then summarized as the mean and standard deviation for all participants and expressed as hours·nanogram/milliliter (hr·ng/mL).|Treatment Period 1: Day 1 (Visit 2), Day 2 (Visit 3), Days 3 to 6 (Visits 4 to 7); Treatment Period 2: Day 8 (Visit 8), Day 9 (Visit 9), Days 10 to 13 (Visits 10 to 13)|The PK Analysis Set was the group of subjects who had sufficient PK data for at least 1 PK parameter to be derived. Subjects with predose lenvatinib concentration >5% of their own Cmax, and subjects who experienced emesis at or before 2x median tmax were excluded from data analysis for bioavailability.|||hr·ng/mL||Standard Deviation|Mean
2552566|NCT02792777|Secondary|Comparison of Method Efficiency in Terms of Cost|The investigators will assess the efficiency of implementation of the two methods, with efficiency assessed by cost to complete a single concept mapping iteration (24 participants) and cost to complete one set of interviews performed to saturation (30 interviews). This efficiency analysis is structured for what would need to be budgeted in a grant application, and will provide useful information for general planning needs for method implementation.|Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days||||Dollars|||Number
2552567|NCT02792777|Secondary|Comparison of Method Efficiency in Terms of Time|The investigators will assess the efficiency of implementation of the two methods, with efficiency including time required by researchers (team of 3) and patient-participants to complete each method. The investigators will compare the efficiency of conducting one concept mapping iteration (24 participants) to the efficiency of performing one set of interviews done to theme saturation (30 interviews). This efficiency analysis is structured for what would need to be budgeted in a grant application, and will provide useful information for general planning needs for method implementation.|Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days||||Hours|||Number
2552568|NCT02792777|Primary|Comprehensiveness of Concept Mapping|"The investigators will measure the comprehensiveness of outcomes elicited in one concept mapping group compared to multiple groups. The investigators will assess concept mapping saturation, wherein we compare the patient-important outcomes that emerge from each CM group. The investigators will use the outcomes from our first group as the baseline data, and will determine the amount of new data added from including a second/third group. This assessment will allow us to draw a basic concept mapping saturation curve."|3 days for one concept mapping group|This analysis is of the number of patient-important outcomes per concept mapping group.|||Reported patient-important outcomes|||Number
2552651|NCT02791763|Secondary|Number of PD Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks|Number of PD participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented.|Up to week 52|Efficacy PD Population|||Participants|||Count of Participants
2552569|NCT02792777|Primary|Comprehensiveness of Interviews Compared to Three Concept Mapping Groups|"The investigators will use a qualitative content analysis approach to analyze interview transcripts, with one of the codes being goals. All ideas coded to goals that are in any way relevant to patients' diabetes care will be extracted to create a list of patient-important outcomes. The investigators will then determine the proportion of patient-important outcomes identified in interviews that are present in an aggregate list of patient-important outcomes generated from the brainstorming session of all three concept mapping groups. The investigators will also identify the presence of additional patient-important outcomes in three concept mapping groups that were not identified in interviews."|Interviewed patients participated for 1 day; One group of concept mapping patients participated for 3 days||||Reported patient-important outcomes|||Number
2552570|NCT02792777|Primary|Comprehensiveness of Interviews as Compared to One Concept Mapping Group|"The investigators will use a qualitative content analysis approach to analyze interview transcripts from one healthcare setting, with one of the codes being goals. All ideas coded to goals that are in any way relevant to patients' diabetes care will be extracted to create a list of patient-important outcomes. The investigators will then determine the proportion of patient-important outcomes identified in the interviews from one healthcare setting that are present in the list of patient-important outcomes generated from the initial concept mapping group during the brainstorming session. The investigators will also identify the presence of unique outcomes found in each method."|Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days||||Reported patient-important outcomes|||Number
2552571|NCT02792699|Secondary|Number of Participants With Clinically Significant Laboratory Findings|Clinically significant clinical laboratory findings were defined as laboratory results that were ≥ Grade 3, based on the CTCAE version 4.03.|Day 1 through the end of study (48 weeks).|All randomized participants who received at least 1 infusion of study drug (safety analysis set)|||Participants|||Count of Participants
2552572|NCT02792699|Secondary|Number of Participants Who Developed Anti-drug Antibodies|"Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect antibodies capable of binding to ABP 798/rituximab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based assay to determine neutralizing activity against ABP 798/rituximab (Neutralizing Antibody Assay).~Developing antibody incidence was defined as participants with a negative or no binding antibody result at baseline and a positive antibody result at any post-baseline time point."|Day 1 through the end of study (48 weeks).|Participants with a binding negative or no result at baseline and an available postbaseline result|||Participants|||Count of Participants
2552573|NCT02792699|Secondary|Number of Participants With Adverse Events After the First Dose|"Adverse events (AEs) were graded by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening AE, and Grade 5 = death due to AE.~A serious AE (SAE) was defined as an AE that met at least 1 of the following serious criteria:~fatal~life-threatening~required inpatient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event. The adverse events of interest prespecified for this study included infusion reactions including hypersensitivity, cardiac disorders, serious infections, progressive multifocal leukoencephalopathy, hematological reactions, hepatitis B reactivation, opportunistic infections, hypogammaglobulinemia, severe mucocutaneous reactions, and gastrointestinal perforation."|From day 1 until the first infusion of the second dose (week 24)|All randomized participants who received at least 1 infusion of study drug (safety analysis set)|||Participants|||Count of Participants
2552574|NCT02792699|Secondary|Duration of Complete Depletion in CD19+ Cell Count|Duration of CD19+ B-cell complete depletion was defined as the time from the first incidence of complete depletion of CD19+ cell count (CD19+ cell count < 20 cells/μL) to when the CD19+ cell count first increased to ≥ 20 cells/μL. Participants whose CD19+ cell count did not increase to ≥ 20 cells/μL were censored at the last CD19+ assessment date.|CD19+ cell count was assessed at baseline, days 2, 3, weeks 4, 24, and 48|Full analysis set participants who had a CD19+ complete depletion for at least one postdose time point.|||days||90% Confidence Interval|Median
2552575|NCT02792699|Secondary|Percentage of Participants With Complete Depletion in CD19+ Cell Count on Day 3|Complete depletion of cluster of differentiation (CD) 19 positive cells was defined as a CD19+ cell count < 20 cell/μL (0.02 x 10⁹ cell/L).|Day 3|Full analysis set participants with a day 3 CD19+ cell count; participants with missing CD19+ cell counts at baseline or with CD19+ cell count < 20 cell/μL at baseline were excluded from the analysis.|||percentage of participants|||Number
2552576|NCT02792699|Secondary|Hybrid ACR|The hybrid ACR combines the ACR 20/50/70 response with the mean percent change in all 7 ACR core components, thus providing a percent improvement from baseline on a continuous scale. For each participant, the mean percent improvement from baseline across the 7 ACR core set measures (tender joint count, swollen joint count, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, disability index of the HAQ, and CRP) was calculated (a positive change indicates improvement, and the maximum worst change is limited to -100%) and the ACR20, ACR50, and ACR70 response is determined. The hybrid ACR is determined from a reference table taking into account both ACR response and mean percent improvement in the core set measures. Scores can range from -100% (maximal worsening) to 100% (maximal improvement).|Baseline and weeks 8, 12, 24, 40, and 48|Full analysis set with observed data|||percent improvement||Standard Error|Least Squares Mean
2552577|NCT02792699|Secondary|Percentage of Participants With an ACR70 Response|"A positive ACR70 response is defined if the following 3 criteria for improvement from baseline were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global health assessment (measured on a 100 mm VAS);~Investigator's global health assessment (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein concentration."|Baseline and Weeks 8, 12, 24, 40, and 48|Full analysis set with observed data|||percentage of participants|||Number
2552652|NCT02791763|Secondary|Percentage of ND Participants Who Had an Hgb Increase of More Than 2 g/dL Over Any 4 Weeks|Percentage of ND participants who had an Hgb increase of more than 2 g/dL over any 4 weeks is presented.|Up to week 52|ITT Population|||Percentage of participants|||Number
2552578|NCT02792699|Secondary|Percentage of Participants With an ACR50 Response|"A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global health assessment (measured on a 100 mm VAS);~Investigator's global health assessment (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein concentration."|Baseline and Weeks 8, 12, 24, 40, and 48|Full analysis set with observed data|||percentage of participants|||Number
2552579|NCT02792699|Secondary|Percentage of Participants With an ACR20 Response|"A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global health assessment (measured on a 100 mm VAS);~Investigator's global health assessment (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein concentration."|Baseline and Weeks 8, 12, 24, 40, and 48|Full analysis set with observed data|||percentage of participants|||Number
2552580|NCT02792699|Secondary|Change From Baseline in Disease Activity Score 28-CRP at Weeks 8, 12, 40, and 48|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count~C-reactive protein (CRP)~Patient's global health assessment measured on a 100 mm VAS, where 0 mm = no RA activity and 100 mm = worst RA activity imaginable.~DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and weeks 8, 12, 40, and 48|Full analysis set with observed data|||units on a scale||Standard Error|Least Squares Mean
2552581|NCT02792699|Secondary|Change From Baseline in Disease Activity Score 28-CRP at Week 24|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count~C-reactive protein (CRP)~Patient's global health assessment measured on a 100 mm VAS, where 0 mm = no RA activity and 100 mm = worst RA activity imaginable.~DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and Week 24|Full analysis set with observed data conducted using a repeated measures analysis in which data from all assessed postbaseline time points were included.|||units on a scale||Standard Error|Least Squares Mean
2552582|NCT02792699|Secondary|AUC0-12 wk/AUCinf|Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.|Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).|The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2552583|NCT02792699|Secondary|Percent of AUC Extrapolation (AUC%Extrap)|Percent of AUC extrapolated to infinity in AUCinf. Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.|Day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).|The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available AUC%extrap data.|||percent extrapolation||Geometric Coefficient of Variation|Geometric Mean
2552584|NCT02792699|Secondary|Mean Residence Time (MRT)|Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.|Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).|The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available MRT data.|||hours||Geometric Coefficient of Variation|Geometric Mean
2552585|NCT02792699|Secondary|Clearance (CL)|Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.|Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).|The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available CL data.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2552586|NCT02792699|Secondary|Terminal Elimination Rate Constant (λz)|Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.|Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57 and 85 (week 12).|The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available λz data.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2552587|NCT02792699|Secondary|Terminal Elimination Half-life (t1/2)|Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.|Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).|The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available T1/2 data.|||hours||Geometric Coefficient of Variation|Geometric Mean
2552608|NCT02792062|Secondary|Number of Participants With TEAEs Related to Body Weight||Day 1 up to 12 days after last dose of study drug (Day 41)|The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.|||participants|||Number
2552588|NCT02792699|Secondary|Last Measurable Serum Concentration After the Second Infusion up to Week 12 (Clast)|Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.|Day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).|The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available Clast data.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2552589|NCT02792699|Secondary|Time of Maximum Observed Drug Concentration (Tmax) After the First and Second Infusions of the First Dose|Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.|Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).|The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available Tmax data at each time point.|||hours||Inter-Quartile Range|Median
2552590|NCT02792699|Secondary|Maximum Observed Drug Concentration (Cmax) After the First Infusion of the First Dose|Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.|Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose and day 15, predose.|The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available Cmax data.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2552591|NCT02792699|Secondary|Area Under the Serum Concentration-time Curve From Predose on Day 1 to Week 12 (AUC0-12wk)|Area under the serum concentration-time curve from time 0 on day 1 prior to the first infusion of the first dose to week 12. Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. AUC0-12wk was estimated using the linear trapezoidal rule.|Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hour postdose, and at days 29, 57, and 85 (week 12).|The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available AUC0-12wk data.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2552592|NCT02792699|Secondary|Area Under the Serum Concentration-time Curve From Predose on Day 1 to 14 Days Postdose (AUC0-14day)|Area under the serum concentration-time curve from time 0 on day 1 prior to the first infusion of the first dose to 14 days postdose. Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. AUC0-14day was estimated using the linear trapezoidal rule.|Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose and day 15, predose.|The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available AUC0-14day data.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2552593|NCT02792699|Primary|Maximum Observed Drug Concentration (Cmax) After the Second Infusion of the First Dose|Maximum observed concentration following the second infusion of the first dose (day 15). Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.|Day 15, pre-dose, end of infusion, and 3, 6, 24, and 48 hours, and 2, 6, and 10 weeks postdose.|The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available Cmax data on day 15.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2552594|NCT02792699|Primary|Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) After the Second Infusion of the First Dose|Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) following the second infusion of the first dose (day 15). Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. AUCinf was estimated using the linear trapezoidal rule.|Day 15, pre-dose, end of infusion, and 3, 6, 24, and 48 hours, and 2, 6, and 10 weeks postdose.|The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available AUCinf data. Participants with unreliable terminal elimination rate constant values were excluded.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2552595|NCT02792517|Secondary|Number of Participants Who Developed Anti-erenumab Binding Antibodies|Blood samples were assessed for anti-erenumab binding antibodies. Samples testing positive for binding antibodies were also tested for neutralizing antibodies.|Baseline and day 150|The safety analysis set consisted of all participants who received at least one dose of study drug (erenumab).|||Participants|||Count of Participants
2552596|NCT02792517|Secondary|Number of Participants With Treatment-emergent Adverse Events|"A treatment-related adverse event (AE) is any treatment-emergent AE that per investigator review has a reasonable possibility of being caused by the study drug.~A device-related AE is any treatment-emergent AE that per investigator review has a reasonable possibility of being caused by the device (prefilled syringe) used to administer study drug."|From administration of erenumab on study day 66 through the end of the follow-up period on study day 150 (up to 84 days).|The safety analysis set consisted of all participants who received at least one dose of study drug (erenumab).|||Participants|||Count of Participants
2552597|NCT02792517|Secondary|Time to Reach the Maximum Concentration (Tmax) of Norelgestromin|The pharmacokinetics of norelgestromin (NGMN), an active metabolite of norgestimate, were characterized during cycle 2 following the last active dose of oral contraceptive in the cycle (cycle day 21) without erenumab, and during cycle 3 following the last active dose of oral contraceptive in the cycle (cycle day 21), 11 days after a single dose of erenumab.|Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.|The pharmacokinetic (PK) analysis set included all participants for whom at least 1 EE, NGMN, and NG PK parameter or endpoint could be adequately estimated. Data are reported for participants with observations at each time point.|||hours||Full Range|Median
2552609|NCT02792062|Secondary|Number of Participants With TEAEs Related to Vital Signs (Presyncope)||Day 1 up to 12 days after last dose of study drug (Day 41)|The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.|||participants|||Number
2552598|NCT02792517|Secondary|Time to Reach the Maximum Concentration (Tmax) of Norgestrel|The pharmacokinetics of norgestrel (NG), an active metabolite of norgestimate, were characterized during cycle 2 following the last active dose of oral contraceptive in the cycle (cycle day 21) without erenumab, and during cycle 3 following the last active dose of oral contraceptive in the cycle (cycle day 21), 11 days after a single dose of erenumab.|Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.|The pharmacokinetic (PK) analysis set included all participants for whom at least 1 EE, NGMN, and NG PK parameter or endpoint could be adequately estimated. Data are reported for participants with observations at each time point.|||hours||Full Range|Median
2552599|NCT02792517|Secondary|Time to Reach the Maximum Concentration (Tmax) of Ethinyl Estradiol|The pharmacokinetics of ethinyl estradiol (EE) were characterized during cycle 2 following the last active dose of oral contraceptive in the cycle (cycle day 21) without erenumab, and during cycle 3 following the last active dose of oral contraceptive in the cycle (cycle day 21), 11 days after a single dose of erenumab.|Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.|The pharmacokinetic (PK) analysis set included all participants for whom at least 1 EE, NGMN, and NG PK parameter or endpoint could be adequately estimated. Data are reported for participants with observations at each time point.|||hours||Full Range|Median
2552600|NCT02792517|Primary|Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours Postdose (AUCtau) for Norelgestromin|The pharmacokinetics of norelgestromin (NGMN), an active metabolite of norgestimate, were characterized during cycle 2 following the last active dose of oral contraceptive in the cycle (cycle day 21) without erenumab, and during cycle 3 following the last active dose of oral contraceptive in the cycle (cycle day 21), 11 days after a single dose of erenumab.|Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.|The pharmacokinetic (PK) analysis set included all participants for whom at least 1 EE, NGMN, and NG PK parameter or endpoint could be adequately estimated. Data are reported for participants with observations at each time point.|||pg/mL*hr||Standard Deviation|Mean
2552601|NCT02792517|Primary|Maximum Observed Plasma Concentration (Cmax) of Norelgestromin|The pharmacokinetics of norelgestromin (NGMN), an active metabolite of norgestimate, were characterized during cycle 2 following the last active dose of oral contraceptive in the cycle (cycle day 21) without erenumab, and during cycle 3 following the last active dose of oral contraceptive in the cycle (cycle day 21), 11 days after a single dose of erenumab.|Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.|The pharmacokinetic (PK) analysis set included all participants for whom at least 1 EE, NGMN, and NG PK parameter or endpoint could be adequately estimated. Data are reported for participants with observations at each time point.|||pg/mL||Standard Deviation|Mean
2552602|NCT02792517|Primary|Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours Postdose (AUCtau) for Norgestrel|The pharmacokinetics of norgestrel (NG), an active metabolite of norgestimate, were characterized during cycle 2 following the last active dose of oral contraceptive in the cycle (cycle day 21) without erenumab, and during cycle 3 following the last active dose of oral contraceptive in the cycle (cycle day 21), 11 days after a single dose of erenumab.|Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.|The pharmacokinetic (PK) analysis set included all participants for whom at least 1 EE, NGMN, and NG PK parameter or endpoint could be adequately estimated. Data are reported for participants with observations at each time point.|||pg/mL*hr||Standard Deviation|Mean
2552603|NCT02792517|Primary|Maximum Observed Plasma Concentration (Cmax) of Norgestrel|The pharmacokinetics of norgestrel (NG), an active metabolite of norgestimate, were characterized during cycle 2 following the last active dose of oral contraceptive in the cycle (cycle day 21) without erenumab, and during cycle 3 following the last active dose of oral contraceptive in the cycle (cycle day 21), 11 days after a single dose of erenumab.|Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.|The pharmacokinetic (PK) analysis set included all participants for whom at least 1 EE, NGMN, and NG PK parameter or endpoint could be adequately estimated. Data are reported for participants with observations at each time point.|||pg/mL||Standard Deviation|Mean
2552604|NCT02792517|Primary|Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours Postdose (AUCtau) for Ethinyl Estradiol|The pharmacokinetics of ethinyl estradiol (EE) were characterized during cycle 2 following the last active dose of oral contraceptive in the cycle (cycle day 21) without erenumab, and during cycle 3 following the last active dose of oral contraceptive in the cycle (cycle day 21), 11 days after a single dose of erenumab.|Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.|The pharmacokinetic (PK) analysis set included all participants for whom at least 1 EE, NGMN, and NG PK parameter or endpoint could be adequately estimated. Data are reported for participants with observations at each time point.|||pg/mL*hr||Standard Deviation|Mean
2552605|NCT02792517|Primary|Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol|The pharmacokinetics of ethinyl estradiol (EE) were characterized during cycle 2 following the last active dose of oral contraceptive in the cycle (cycle day 21) without erenumab, and during cycle 3 following the last active dose of oral contraceptive in the cycle (cycle day 21), 11 days after a single dose of erenumab.|Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.|The pharmacokinetic (PK) analysis set included all participants for whom at least 1 EE, NGMN, and NG PK parameter or endpoint could be adequately estimated. Data are reported for participants with observations at each time point.|||pg/mL||Standard Deviation|Mean
2552606|NCT02792062|Secondary|Number of Participants With TEAEs Related to Clinical Laboratory Tests|Clinical laboratory tests included hematology, serum chemistry, and urinalysis.|Day 1 up to 12 days after last dose of study drug (Day 41)|The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.|||participants|||Number
2552607|NCT02792062|Secondary|Number of Participants With TEAEs Related to Electrocardiograms (ECG)||Day 1 up to 12 days after last dose of study drug (Day 41)|The safety analysis set included all participants who received at least one dose of the study drug. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.|||participants|||Number
2552611|NCT02792062|Primary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-385||Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose|The PK analysis set included all participants who received the study drug, had no major protocol violation, fulfilled the minimum protocol specifications, and had data available for the PK analysis. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.|||ng*hr/mL||Standard Deviation|Mean
2552612|NCT02792062|Primary|AUC(0-120): Area Under the Plasma Concentration-time Curve From Time 0 to 120 Hours Postdose for TAK-385||Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose|The PK analysis set included all participants who received the study drug, had no major protocol violation, fulfilled the minimum protocol specifications, and had data available for the PK analysis. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.|||ng*hr/mL||Standard Deviation|Mean
2552613|NCT02792062|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385||Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 120hrs; up to 120 hrs) post-dose|The PK analysis set included all participants who received the study drug, had no major protocol violation, fulfilled the minimum protocol specifications, and had data available for the PK analysis. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
2552614|NCT02792062|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-385||Day 1: Pre-dose and at multiple time points (up to 120 hrs) post-dose|The PK analysis set included all participants who received the study drug, had no major protocol violation, fulfilled the minimum protocol specifications, and had data available for the PK analysis. One participant discontinued study without receiving TAK-385 after breakfast in intervention period 3.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2552615|NCT02792049|Secondary|Number of Participants Who Preferred the Modified Bag Valve Mask (BVM)|Each subject provides a binary response as to whether he/she overall prefers using the modified BVM instead of the conventional BVM.|Within 10 minutes of study completion||||participants|||Number
2552616|NCT02792049|Secondary|Modified Bag Valve Mask (BVM) Willingness to Use in Emergency Situation|Subject reported willingness to use the modified BVM in a real life emergency situation as measured on a Likert scale ranging 1 (not at all willing to use) to 5 (very willing to use).|Within 10 minutes of study completion||||Units on a scale||Inter-Quartile Range|Median
2552617|NCT02792049|Secondary|Modified Bag Valve Mask (BVM) Better Seal Formation|Subjects response using a Likert scale (1-5) regarding their perceptions of whether the modified BVM forms a better seal compared to a standard BVM: 1 (much worse seal formation) to 5 (much better seal formation).|Within 10 minutes of study completion||||Units on a scale||Inter-Quartile Range|Median
2552618|NCT02792049|Secondary|Modified Bag Valve Mask (BVM) Ease of Use|Likert scale measuring subject's perceived ease of use of the modified BVM device from not at all easy to use (1) to very easy to use (5).|Within 10 minutes of study completion||||Units on a scale||Inter-Quartile Range|Median
2552619|NCT02792049|Primary|Mean Received Tidal Volume|Each participant was asked to provide BVM ventilation using the assigned devices at a rate of 10 breaths per minute for 3 minutes for a total of 30 breaths. Tidal volume of each delivered breath was recorded in milliliters|3 minutes||||milliliters||Standard Deviation|Mean
2552620|NCT02791763|Secondary|Maximum Observed Concentration (Cmax) of Daprodustat for All Dose Levels in ND and PD Participants|Blood samples were collected at indicated timepoints. PK parameters of Daprodustat were calculated using non-compartmental method. Cmax is presented for combined Week 12 and 24. Geometric mean and geometric coefficient of variation is presented. NA indicates that the data is not available since geometric coefficient of variation could not be calculated for a single participant.|1, 2, 3 and 4 hours post dose at Weeks 12 and 24|PK Population. Only those participants with data available at the specified data points were analyzed.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2552621|NCT02791763|Secondary|Area Under the Concentration-time Curve From Time Zero Extrapolated to 4 Hours (AUC[0-4]) of Daprodustat for All Dose Levels in ND and PD Participants|Blood samples were collected at indicated timepoints. Pharmacokinetic (PK) parameters of Daprodustat were calculated using non-compartmental method. AUC (0-4) is presented for combined Week 12 and 24. Geometric mean and geometric coefficient of variation is presented. NA indicates that the data is not available since geometric coefficient of variation could not be calculated for a single participant.|1, 2, 3 and 4 hours post dose at Weeks 12 and 24|PK Population comprised of all Daprodustat-treated participants from whom PK samples were collected and analyzed. Only those participants with data available at the specified data points were analyzed.|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2552622|NCT02791763|Secondary|Change From Baseline in TIBC in PD Participants|Change from Baseline in TIBC in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in TIBC is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.|Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52|Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||µmol/L||95% Confidence Interval|Mean
2552623|NCT02791763|Secondary|Change From Baseline in Total Iron Binding Capacity (TIBC) in ND Participants|Change from Baseline in TIBC in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in TIBC is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.|Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||µmol/L||95% Confidence Interval|Mean
2552624|NCT02791763|Secondary|Change From Baseline in Serum Iron in PD Participants|Change from Baseline in serum iron in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Serum iron is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.|Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52|Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||µmol/L||95% Confidence Interval|Mean
2552625|NCT02791763|Secondary|Change From Baseline in Serum Iron in ND Participants|Change from Baseline in serum iron in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Serum iron is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.|Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Micromoles per liter (µmol/L)||95% Confidence Interval|Mean
2552626|NCT02791763|Secondary|Percent Change From Baseline in Hepcidin in PD Participants|Percent change from Baseline in Hepcidin in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100*(exponential [mean change on log scale]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in Hepcidin is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.|Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52|Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Percent change||95% Confidence Interval|Geometric Mean
2552627|NCT02791763|Secondary|Percent Change From Baseline in Hepcidin in ND Participants|Percent change from Baseline in Hepcidin in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100*(exponential [mean change on log scale]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in Hepcidin is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.|Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Percent change||95% Confidence Interval|Geometric Mean
2552628|NCT02791763|Secondary|Percent Change From Baseline in TSAT in PD Participants|Percent change from Baseline in TSAT in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100*(exponential [mean change on log scale]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in TSAT is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.|Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52|Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Percent change||95% Confidence Interval|Geometric Mean
2552629|NCT02791763|Secondary|Percent Change From Baseline in Transferrin Saturation (TSAT) in ND Participants|Percent change from Baseline in TSAT in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated as 100*(exponential [mean change on log scale]-1). Adjusted geometric mean and 95% confidence interval for percent change from Baseline in TSAT is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.|Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Percent change||95% Confidence Interval|Geometric Mean
2552630|NCT02791763|Secondary|Change From Baseline in Ferritin in PD Participants|Change from Baseline in Ferritin in PD participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Ferritin is presented. For adjusted values, analysis was performed by MMRM with covariates of Baseline, visit and Baseline-by-visit interaction.|Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52|Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||µg/L||95% Confidence Interval|Mean
2552631|NCT02791763|Secondary|Change From Baseline in Ferritin in ND Participants|Change from Baseline in Ferritin in ND participants was summarized at each assessment visit. The Baseline value was the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Adjusted mean and 95% confidence interval for change from Baseline in Ferritin is presented. For adjusted values, analysis was performed by MMRM with covariates of treatment, Baseline, visit, treatment-by-visit interaction and Baseline-by-visit interaction.|Baseline (Day 1 pre-dose) and Weeks 4, 16, 28, 40 and 52|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Micrograms per liter (µg/L)||95% Confidence Interval|Mean
2552632|NCT02791763|Secondary|Percentage of PD Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period|Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of PD participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized.|Weeks 40 to 52|Efficacy PD Population. Only those participants with data available at the specified data points were analyzed.|||Percentage of participants|||Number
2560607|NCT02662569|Secondary|Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2552633|NCT02791763|Secondary|Percentage of ND Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period|Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of ND participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized.|Weeks 40 to 52|ITT Population. Only those participants with data available at the specified data points were analyzed.|||Percentage of participants|||Number
2552634|NCT02791763|Secondary|Number of PD Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period|Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of PD participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized.|Weeks 40 to 52|Efficacy PD Population. Only those participants with data available at the specified data points were analyzed.|||Participants|||Count of Participants
2552635|NCT02791763|Secondary|Number of ND Participants Who Used Oral Iron During the Primary Efficacy Evaluation Period|Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of ND participants who used oral iron during the primary efficacy evaluation period (Weeks 40 to 52) were summarized.|Weeks 40 to 52|ITT Population. Only those participants with data available at the specified data points were analyzed.|||Participants|||Count of Participants
2552636|NCT02791763|Secondary|Percentage of PD Participants Who Used Oral Iron During the Treatment Period|Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of PD participants who used oral iron during the treatment period were summarized.|Up to week 52|Efficacy PD Population|||Percentage of participants|||Number
2552637|NCT02791763|Secondary|Percentage of ND Participants Who Used Oral Iron During the Treatment Period|Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The percentage of ND participants who used oral iron during the treatment period were summarized.|Up to week 52|ITT Population|||Percentage of participants|||Number
2552638|NCT02791763|Secondary|Number of PD Participants Who Used Oral Iron During the Treatment Period|Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of PD participants who used oral iron during the treatment period were summarized.|Up to week 52|Efficacy PD Population|||Participants|||Count of Participants
2552639|NCT02791763|Secondary|Number of ND Participants Who Used Oral Iron During the Treatment Period|Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. The number of ND participants who used oral iron during the treatment period were summarized.|Up to week 52|ITT Population|||Participants|||Count of Participants
2552640|NCT02791763|Secondary|Monthly Average Dose of Oral Iron During the Primary Efficacy Evaluation Period in PD Participants|Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron dose during the primary efficacy evaluation period (Weeks 40 to 52) = Total oral iron dose (mg) during the primary efficacy evaluation period / (duration in the period in days / 30.4375 days). Monthly average dose of oral iron during the primary efficacy evaluation period in PD participants is presented.|Weeks 40 to 52|Efficacy PD Population. Only those participants with data available at the specified data points were analyzed.|||Milligrams||Standard Deviation|Mean
2552641|NCT02791763|Secondary|Monthly Average Dose of Oral Iron During the Primary Efficacy Evaluation Period in ND Participants|Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron dose during the primary efficacy evaluation period (Weeks 40 to 52) = Total oral iron dose (mg) during the primary efficacy evaluation period / (duration in the period in days / 30.4375 days). Monthly average dose of oral iron during the primary efficacy evaluation period in ND participants is presented.|Weeks 40 to 52|ITT Population. Only those participants with data available at the specified data points were analyzed.|||Milligrams||Standard Deviation|Mean
2552642|NCT02791763|Secondary|Monthly Average Dose of Oral Iron During the Treatment Period in PD Participants|Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron = Total oral iron dose (mg) / (duration in days / 30.4375 days). Monthly average dose of oral iron during the treatment period in PD participants is presented.|Up to Week 52|Efficacy PD Population|||Milligrams||Standard Deviation|Mean
2552643|NCT02791763|Secondary|Monthly Average Dose of Oral Iron During the Treatment Period in ND Participants|Supplemental iron therapy were received by participants if required during treatment period. Participants who used ferric citrate were counted as oral iron use. Monthly average oral iron = Total oral iron dose (mg) / (duration in days / 30.4375 days). Monthly average dose of oral iron during the treatment period in ND participants is presented.|Up to Week 52|ITT Population|||Milligrams||Standard Deviation|Mean
2552644|NCT02791763|Secondary|Number of Episodes With Hgb Level of More Than 13.0 g/dL in PD Participants|Number of episodes with Hgb level of more than 13.0 g/dL in PD participants is presented.|Up to week 52|Efficacy PD Population|||Episodes|||Number
2552645|NCT02791763|Secondary|Number of Episodes With Hgb Level of More Than 13.0 g/dL in ND Participants|Number of episodes with Hgb level of more than 13.0 g/dL in ND participants is presented.|Up to week 52|ITT Population|||Episodes|||Number
2552646|NCT02791763|Secondary|Percentage of PD Participants Who Had an Hgb Level of More Than 13.0 g/dL|Percentage of PD participants who had an Hgb level of more than 13.0 g/dL is presented.|Up to week 52|Efficacy PD Population|||Percentage of participants|||Number
2552647|NCT02791763|Secondary|Number of PD Participants Who Had an Hgb Level of More Than 13.0 g/dL|Number of PD participants who had an Hgb level of more than 13.0 g/dL is presented.|Up to week 52|Efficacy PD Population|||Participants|||Count of Participants
2552648|NCT02791763|Secondary|Percentage of ND Participants Who Had an Hgb Level of More Than 13.0 g/dL|Percentage of ND participants who had an Hgb level of more than 13.0 g/dL is presented.|Up to week 52|ITT Population|||Percentage of participants|||Number
2552658|NCT02791763|Secondary|Time to Reach the Lower Target Hgb Level (11.0 g/dL) in PD Participants|The time (in days) to reach the lower target Hgb level (11.0 g/dL) was summarized using 25th percentile (P25), median, and 75th percentile (P75) by Kaplan-Meier method. Participants who did not reach the lower Hgb target were considered as censored cases. Participants who were randomized as Hgb >= 11.0 g/dL were excluded in this summary.|Up to week 52|Efficacy PD Population. Only those participants who experienced this event were included in analysis.|||Days||Inter-Quartile Range|Median
2552659|NCT02791763|Secondary|Time to Reach the Lower Target Hgb Level (11.0 g/dL) in ND Participants|The time (in days) to reach the lower target Hgb level (11.0 g/dL) was summarized using 25th percentile (P25), median, and 75th percentile (P75) by Kaplan-Meier method. Participants who did not reach the lower Hgb target were considered as censored cases. Participants who were randomized as Hgb >= 11.0 g/dL were excluded in this summary.|Up to week 52|ITT Population. Only those participants who experienced this event were included in analysis.|||Days||Inter-Quartile Range|Median
2552660|NCT02791763|Secondary|Percentage of Time With Hgb Within the Target Range (11.0 to 13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in PD Participants|Mean percentage of time with Hgb within the target range (11.0 to 13.0 g/dL) is summarized during the primary efficacy evaluation period (Weeks 40 to 52).|Weeks 40 to 52|Efficacy PD Population. Only those participants with data available at the specified data points were analyzed.|||Percentage of time||Standard Deviation|Mean
2552661|NCT02791763|Secondary|Percentage of Time With Hgb Within the Target Range (11.0 to 13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants|Mean percentage of time with Hgb within the target range (11.0 to 13.0 g/dL) is summarized during the primary efficacy evaluation period (Weeks 40 to 52).|Weeks 40 to 52|ITT Population. Only those participants with data available at the specified data points were analyzed.|||Percentage of time||Standard Deviation|Mean
2552662|NCT02791763|Secondary|Percentage of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit|Percentage of PD participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit.|Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52|Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Percentage of Participants|||Number
2552663|NCT02791763|Secondary|Number of PD Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit|Number of PD participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit.|Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52|Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2552664|NCT02791763|Secondary|Percentage of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit|Percentage of ND participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit.|Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Percentage of Participants|||Number
2552665|NCT02791763|Secondary|Number of ND Participants Who Had Hgb Level Within the Target Range (11.0-13.0 g/dL) at Each Assessment Visit|Number of ND participants with Hgb level within the target range (11.0 to 13.0 g/dL) are summarized at each assessment visit.|Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2552666|NCT02791763|Secondary|Change From Baseline in Hgb Values at Each Assessment Visit in PD Participants|Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb values at each assessment visit in PD participants is presented.|Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52|Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||g/dL||Standard Deviation|Mean
2552667|NCT02791763|Secondary|Change From Baseline in Hgb Values at Each Assessment Visit in ND Participants|Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb values at each assessment visit in ND participants is presented.|Baseline (Day 1), Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||g/dL||Standard Deviation|Mean
2552668|NCT02791763|Secondary|Hgb Values at Each Assessment Visit in PD Participants|Hgb values at each assessment visit for PD participants is presented.|Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52|Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||g/dL||Standard Deviation|Mean
2552669|NCT02791763|Secondary|Hgb Values at Each Assessment Visit in ND Participants|Hgb values at each assessment visit for ND participants is presented.|Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44,48 and Week 52|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||g/dL||Standard Deviation|Mean
2552670|NCT02791763|Secondary|Number of Dose Adjustments in PD Participants|Number of dose adjustments in PD participants is presented.|Up to Week 52|Efficacy PD Population|||Number of dose adjustments||Full Range|Median
2552671|NCT02791763|Secondary|Number of Dose Adjustments in ND Participants|Number of dose adjustments in ND participants is presented.|Up to Week 52|ITT Population|||Number of dose adjustments||Full Range|Median
2552672|NCT02791763|Secondary|Duration of Treatment Interruption Due to Hgb >13 g/dL in PD Participants|The duration (in days) of treatment interruption due to Hgb >13 g/dL per participant was summarized descriptively on participants with a period of treatment interruption due to Hgb >13 g/dL.|Up to Week 52|Efficacy PD Population. Only those participants who had Hgb > 13.0 g/dL of Hemocue were included in analysis.|||Days||Full Range|Median
2553097|NCT02783170|Primary|Feasibility Reported as Percentage of Adequate Biospecimens Collected|Percentage of samples collected (sample timepoints collected / total possible sample timepoints)|Approximately 1 year|Safety Population - subjects randomized and received study intervention|||percentage of samples|||Number
2552673|NCT02791763|Secondary|Duration of Treatment Interruption Due to Hgb >13 g/dL in ND Participants|The duration (in days) of treatment interruption due to Hgb >13 g/dL per participant was summarized descriptively on participants with a period of treatment interruption due to Hgb >13 g/dL.|Up to Week 52|ITT Population. Only those participants who had Hgb > 13.0 g/dL of Hemocue were included in analysis.|||Days||Full Range|Median
2552674|NCT02791763|Secondary|Daprodustat Dose Level by Visit in PD Participants|Daprodustat dose level at each assessment visit for PD participants is presented using 25th percentile (P25), median, and 75th percentile (P75).|Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48|Efficacy PD Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||mg/day||Inter-Quartile Range|Median
2552675|NCT02791763|Secondary|Epoetin Beta Pegol Dose Level by Visit in ND Participants|Dose of epoetin beta pegol at a scheduled visit was converted to dose per 4 weeks when the dose frequency was every 2 weeks. Epoetin beta pegol dose level at each assessment visit for ND participants is presented using 25th percentile (P25), median, and 75th percentile (P75).|Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Micrograms per 4 weeks||Inter-Quartile Range|Median
2552676|NCT02791763|Secondary|Daprodustat Dose Level by Visit in ND Participants|Daprodustat dose level at each assessment visit for ND participants is presented using 25th percentile (P25), median, and 75th percentile (P75).|Day 1, Weeks 4,8,12,16,20,24,28,32,36,40,44 and 48|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Milligrams per day (mg/day)||Inter-Quartile Range|Median
2552677|NCT02791763|Secondary|Percentage of PD Participants by Hgb Change From Baseline Category at Week 4|Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to <=-2.0, >-2.0 and <=-1.0, >-1.0 and <=0, >0 and <=1.0, >1.0 and <=2.0, >2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4.|Baseline (Day 1) and Week 4|Efficacy PD Population|||Percentage of Participants|||Number
2552678|NCT02791763|Secondary|Number of PD Participants by Hgb Change From Baseline Category at Week 4|Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to <=-2.0, >-2.0 and <=-1.0, >-1.0 and <=0, >0 and <=1.0, >1.0 and <=2.0, >2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4.|Baseline (Day 1) and Week 4|Efficacy PD Population|||Participants|||Count of Participants
2552679|NCT02791763|Secondary|Percentage of ND Participants by Hgb Change From Baseline Category at Week 4|Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to <=-2.0, >-2.0 and <=-1.0, >-1.0 and <=0, >0 and <=1.0, >1.0 and <=2.0, >2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4.|Baseline (Day 1) and Week 4|ITT Population. Only those participants with data available at the specified data points were analyzed.|||Percentage of participants|||Number
2552680|NCT02791763|Secondary|Number of ND Participants by Hgb Change From Baseline Category at Week 4|Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Number of participants by Hgb change from Baseline is categorized to <=-2.0, >-2.0 and <=-1.0, >-1.0 and <=0, >0 and <=1.0, >1.0 and <=2.0, >2.0 g/dL, then is additionally categorized to within +/- 1.0 g/dL and over +/- 2.0 g/dL. Number of participants have been included in more than one category at Week 4.|Baseline (Day 1) and Week 4|ITT Population. Only those participants with data available at the specified data points were analyzed.|||Participants|||Count of Participants
2552681|NCT02791763|Secondary|Change From Baseline in Hgb at Week 4 in PD Participants|Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb at week 4 in PD participants is presented.|Baseline (Day 1) and Week 4|Efficacy peritoneal dialysis (PD) Population comprised of PD participants who were given randomization number with Hgb measurement at both Baseline and at least one scheduled visits following the Baseline.|||g/dL||Standard Deviation|Mean
2552682|NCT02791763|Secondary|Change From Baseline in Hgb at Week 4 in ND Participants|Baseline Hgb value was the value from the Day 1 visit. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in Hgb at Week 4 in ND participants is presented.|Baseline (Day 1) and Week 4|ITT Population. Only those participants with data available at the specified data points were analyzed.|||g/dL||Standard Deviation|Mean
2552683|NCT02791763|Secondary|Percentage of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)|The percentage of ND participants with observed mean Hgb within the target range during the primary efficacy evaluation period was summarized. Responders were defined as the participants with the mean Hgb within target range during the primary efficacy evaluation period.|Weeks 40 to 52|mITT Population|||Percentage of participants|||Number
2552684|NCT02791763|Secondary|Number of ND Participants With Mean Hgb in the Target Range (11.0-13.0 g/dL) During the Primary Efficacy Evaluation Period (Weeks 40 to 52)|ND participants with observed mean Hgb within the target range during the primary efficacy evaluation period were summarized. Responders were defined as the participants with the mean Hgb within target range during the primary efficacy evaluation period.|Weeks 40 to 52|Modified intent to treat (mITT) comprised of all ITT participants who had at least one Hgb measurement during the efficacy evaluation period.|||Participants|||Count of Participants
2552699|NCT02791438|Secondary|Observed Plasma Concentration for Azilsartan|Reported data were observed plasma concentration for Azilsartan for each arm. Dosage of the study drug after Week 2 (postdose) is different among participants.|Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16|Full analysis set included all the randomized participants. Number analyzed is the number of participants with data available at the given timepoint for this outcome measure.|||ug/L||Standard Deviation|Mean
2552685|NCT02791763|Primary|Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants|The mean hemoglobin during the primary efficacy evaluation period in ND participants was estimated by a statistical model using Mixed Model Repeated Measures (MMRM).|Weeks 40 to 52|Intent to treat (ITT) Population comprised of cohort 1 participants (only erythropoiesis stimulating agent [ESA] users) and cohort 3 participants (both ESA users and ESA non-users) who were given randomization number with Hgb measurement at both Baseline and at least one scheduled visits following the Baseline.|||Grams per deciliter (g/dL)||Standard Error|Mean
2552686|NCT02791659|Primary|Effective Radiation Dose|The effective radiation which represents equivalent dose to eye lens of each personnel were compared between 2 groups.|Immediate after procedure||||mSv||Inter-Quartile Range|Median
2552687|NCT02791516|Secondary|Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck|Bone mineral density (BMD) at the femoral neck was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.|Baseline and month 6|Randomized participants who had a baseline DXA BMD measurement and at least 1 postbaseline DXA BMD measurement at the femoral neck.|||percent change||Standard Error|Least Squares Mean
2552688|NCT02791516|Secondary|Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip|Bone mineral density (BMD) at the total hip was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.|Baseline and month 6|Randomized participants who had a baseline DXA BMD measurement and at least 1 postbaseline DXA BMD measurement at the total hip.|||percent change||Standard Error|Least Squares Mean
2552689|NCT02791516|Primary|Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine|Bone mineral density (BMD) at the lumbar spine was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.|Baseline and month 6|Randomized participants who had a baseline DXA BMD measurement and at least 1 postbaseline DXA BMD measurement at the lumbar spine.|||percent change||Standard Error|Least Squares Mean
2552690|NCT02791490|Secondary|Percentage of Participants Receiving Glycemic Rescue Therapy|Participants who met pre-specified criteria for glycemic rescue received appropriate rescue therapy. The choice of anti-hyperglycemic rescue agent, dose, and regimen was directed by the investigator, as clinically appropriate.|Up to 20 weeks|All randomized participants who received at least 1 dose of study treatment|||Percentage of participants|||Number
2552691|NCT02791490|Secondary|Percentage of Participants With Hemoglobin A1C ≥8.5% at Baseline That Attained A1C Goal of <7% at Week 20|Hemoglobin A1C is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.|Baseline and Week 20|The subgroup of randomized participants who had a baseline hemoglobin A1C ≥8.5%, received at least 1 dose of study medication, and had at least 1 observation for the analysis endpoint|||Percentage of participants|||Number
2552692|NCT02791490|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 20|Plasma glucose was measured on a fasting basis and is expressed as mg/dL. Blood was drawn predose on Day 1 and after 20 weeks of treatment to determine change in FPG levels. The change from baseline represents the Week 20 FPG value minus the Week 0 (baseline) FPG value.|Baseline and Week 20|All randomized participants who received at least 1 dose of study treatment and had at least 1 observation for the analysis endpoint|||mg/dL||95% Confidence Interval|Least Squares Mean
2552693|NCT02791490|Secondary|Percentage of Participants With Hemoglobin A1C <7% at Week 20|Hemoglobin A1C is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.|Week 20|All randomized participants who received at least 1 dose of study treatment and had at least 1 observation for the analysis endpoint|||Percentage of participants|||Number
2552694|NCT02791490|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Up to 20 weeks|All randomized participants who received at least 1 dose of study medication|||Percentage of participants|||Number
2552695|NCT02791490|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Up to 22 weeks|All randomized participants who received at least 1 dose of study medication|||Percentage of participants|||Number
2552696|NCT02791490|Primary|Change From Baseline in Hemoglobin A1C at Week 20|Hemoglobin A1C is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. The change from baseline represents the Week 20 A1C value minus the Week 0 (baseline) A1C value.|Baseline and Week 20|All randomized participants who received at least 1 dose of study medication and had at least 1 observation for the analysis endpoint|||A1C (%)||95% Confidence Interval|Least Squares Mean
2552697|NCT02791438|Secondary|Observed Plasma Concentration for Azilsartan Metabolites (M-II)|Reported data were observed plasma concentration for Azilsartan Metabolites (M-II) for each arm. Dosage of the study drug after Week 2 (postdose) is different among participants.|Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16|Full analysis set included all the randomized participants. Number analyzed is the number of participants with data available at the given timepoint for this outcome measure.|||ug/L||Standard Deviation|Mean
2552698|NCT02791438|Secondary|Observed Plasma Concentration for Azilsartan Metabolites (M-I)|Reported data were observed plasma concentration for Azilsartan Metabolites (M-I) for each arm. Dosage of the study drug after Week 2 (postdose) is different among participants.|Predose and 2 hours postdose Weeks 2, 4, 8, 12 and 2 hours postdose Week 16|Full analysis set included all the randomized participants. Number analyzed is the number of participants with data available at the given timepoint for this outcome measure.|||ug/L||Standard Deviation|Mean
2560608|NCT02662569|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12||Baseline and week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2552700|NCT02791438|Secondary|Percentage Of Participants Who Achieve The Target Blood Pressure|Target blood pressure is defined as the normal reference range for blood pressure by age according to Guidelines for Drug Therapy in Pediatric Patients with Cardiovascular Diseases by the Japanese Circulation Society JCS 2012 (JCS 2012). The data of change from baseline to EOT 1 and EOT 2 were calculated with the evaluable data within the acceptable time points (EOT1 was for up to Week 12 and EOT2 was for up to Week 52) with the largest Study Day was used. Meanwhile, change from baseline to Week 12 and 52 were calculated with the data of Week 12 and 52 respectively. Target blood pressure were described on Guidelines for Drug Therapy in Pediatric Patients with Cardiovascular Diseases by the Japanese Circulation Society JCS 2012 (JCS 2012) (see Links on Registration Section).|Weeks 2, 4, 8, 12,16, 20, 24, 32, 40, 52, Week 54 (Follow-up), EOT 1 (Up to Week 12), EOT 2 (Up to Week 52)|Full analysis set included all the randomized participants. Number analyzed is the number of participants with data available at the given timepoint for this outcome measure.|||percentage of participants|||Number
2552701|NCT02791438|Secondary|Change From Baseline in Office Trough Sitting Diastolic Blood Pressure|Office trough sitting blood pressure is defined as the blood pressure collected in the office while the participant was sitting at a time point immediately before the next dosing, when the blood drug concentration is assumed to be the lowest. A negative change from Baseline indicates improvement. The data of change from baseline to the End of Treatment Period I (EOT 1) and the End of the Treatment Period 2 (EOT 2) were calculated with the evaluable data within the acceptable time points (EOT1 was for up to Week 12 and EOT2 was for up to Week 52) with the largest Study Day was used. Meanwhile, change from baseline to Week 12 and 52 were calculated with the data of Week 12 and 52 respectively.|Baseline (Day 0), Weeks 2, 4, 8, 12,16, 20, 24, 32, 40, 52, Week 54 (Follow-up), EOT 1 (Up to Week 12), EOT 2 (Up to Week 52)|Full analysis set included all the randomized participants. Number analyzed is the number participants with data available at the given timepoint for this outcome measure.|||mmHg||Standard Deviation|Mean
2552702|NCT02791438|Secondary|Change From Baseline in Office Trough Sitting Systolic Blood Pressure|Office trough sitting blood pressure is defined as the blood pressure collected in the office while the participant was sitting at a time point immediately before the next dosing, when the blood drug concentration is assumed to be the lowest. A negative change from Baseline indicates improvement. The data of change from baseline to the End of Treatment Period I (EOT 1) and the End of the Treatment Period 2 (EOT 2) were calculated with the evaluable data within the acceptable time points (EOT1 was for up to Week 12 and EOT2 was for up to Week 52) with the largest Study Day was used. Meanwhile, change from baseline to Week 12 and 52 were calculated with the data of Week 12 and 52 respectively.|Baseline (Day 0), Weeks 2, 4, 8, 12,16, 20, 24, 32, 40, 52, Week 54 (Follow-up), End-of-treatment (EOT) 1 (Up to Week 12), EOT 2 (Up to Week 52)|Full analysis set included all the randomized participants. Number analyzed is the number of participants with data available at the given timepoint for this outcome measure.|||mmHg||Standard Deviation|Mean
2552703|NCT02791438|Primary|Number Of Participants With TEAEs Related To Vital Signs (Hypotension)|A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Vital signs included office standing blood pressure, office sitting pulse rate, office standing pulse rate, and home sitting blood pressure. Any abnormal vital signs findings determined by the investigator to be clinically significant were reported as adverse events.|Up to Week 54|Safety analysis set included all randomized participants who received at least 1 dose of the study drug for the Treatment Period.|||Participants|||Count of Participants
2552704|NCT02791438|Primary|Number Of Participants With TEAEs Related To Resting 12-Lead Electrocardiogram (ECG)|A standard 12-lead ECG was performed while the participant was at rest. Any abnormal ECG findings determined by the investigator to be clinically significant were reported as adverse events.|Up to Week 54|Safety analysis set included all randomized participants who received at least 1 dose of the study drug for the Treatment Period.|||Participants|||Count of Participants
2552705|NCT02791438|Primary|Number Of Participants With Markedly Abnormal Values of Laboratory Parameters|The laboratory values outside the range (Blood Urea Nitrogen (BUN) (mg/dL) >30, Creatinine (mg/dL) >2.0, eGFR (mL/min/1.73m^2) <30, Creatine Kinase (U/L) >5×ULN) are considered markedly abnormal.|Up to Week 54|Safety analysis set included all randomized participants who received at least 1 dose of the study drug for the Treatment Period.|||Participants|||Count of Participants
2552706|NCT02791438|Primary|Number of Participants With TEAEs Related to Anthropometric Measurement (Weight, Height and Body Mass Index (BMI))|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug.|Up to Week 54|Safety analysis set included all randomized participants who received at least 1 dose of the study drug for the Treatment Period.|||Participants|||Count of Participants
2552707|NCT02791438|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs or worsens after receiving study drug.|Up to Week 54|Safety analysis set included all randomized participants who received at least 1 dose of the study drug for the Treatment Period.|||Participants|||Count of Participants
2552708|NCT02791308|Primary|Proportion of Subjects With Treatment Success at Visit 4/Day 15|Proportion of subjects in each treatment group with treatment success, defined as a grade of clear or almost clear (a score of 0 or 1 on the IGA) within all treatment areas at the end of treatment on Visit 4/Day 15|15 days||||Participants|||Count of Participants
2552772|NCT02788747|Secondary|Change in Left Atrial Volume (mL)|Change in Left Atrial Volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.|Baseline to Week 4|All participants for whom Left Atrial Volume was measured at baseline and Week 4|||mL||Standard Deviation|Mean
2552709|NCT02791269|Secondary|Number of Participants With HBeAg Seroconversion|HBeAg seroconversion for HBeAg positive participants was defined as the loss of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe).|Week 48 (end of treatment) and Week 72 (end of follow-up)|"ITT population. Only HBeAg positive participants was planned to be reported. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point."|||participants|||Number
2552710|NCT02791269|Secondary|Number of Participants With Normalization of Alanine Aminotransferase (ALT) Level|ALT is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT level increases. Normal ALT level = less than upper limit of normal (40 units per liter).|Week 48 (end of treatment) and Week 72 (end of follow-up)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point."|||participants|||Number
2552711|NCT02791269|Secondary|Number of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion|HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs). Both HBeAg positive and negative participants were HBsAg positive at baseline and absence of HBsAg (seroconversion) was analyzed.|Week 48 (end of treatment) and Week 72 (end of follow-up)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point."|||participants|||Number
2552712|NCT02791269|Secondary|Number of Participants With HBV-DNA <400 Copies/mL|HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.|Week 48 (end of treatment) and Week 72 (end of follow-up)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified participants with evaluable data for a specified time point."|||participants|||Number
2552713|NCT02791269|Primary|Number of Participants With HBV-DNA <20,000 Copies/mL|HBV-DNA was assessed in plasma samples using quantitative Roche PCR or Taqman tests.|End of 24-weeks follow-up (Week 72)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome."|||participants|||Number
2552714|NCT02791269|Primary|Number of HBeAg Positive Participants With Hepatitis B Virus-deoxy Ribonucleic Acid (HBV-DNA) Less Than (<) 100,000 Copies Per Milliliter (Copies/mL)|HBV-DNA was assessed in plasma samples using quantitative Roche polymerase chain reaction (PCR) or Taqman tests.|End of 24-weeks follow-up (Week 72)|"Intent-to-treat (ITT) population included all participants who received at least one dose of study medication and had one subsequent post baseline assessment. Here, number of participants analyzed signified those participants who were evaluable for this outcome."|||participants|||Number
2552715|NCT02790788|Secondary|Steroid-associated Complications.|Episodes of 1) Hyperglycemia (defined as Blood Glucose >200 mg/dL), 2) Hypernatremia (defined as blood gas analysis-derived sodium ion concentration >150 mEq/L), and 3) Infections (defined as any microbiologically documented, intensive care unit-acquired, or hospital-acquired infection).|Up to 180 days postrandomization.||||Number of Episodes per Patient||Inter-Quartile Range|Median
2552716|NCT02790788|Secondary|Survival to Hospital Discharge With Favorable Functional Outcome.|Survival to hospital discharge with a Cerebral Performance Category (CPC) Score of 1 or 2. The CPC Score ranges can have the following values: 1, 2, 3, 4, and 5; lower Scores correspond to better outcomes, whereas higher Scores reflect worsening outcomes, e.g. a Score of 4 means Coma or Vegetative state, and a Score of 5 means Brain Death.|Up to 180 days postrandomization.||||Participants|||Count of Participants
2552717|NCT02790788|Secondary|Early Postresuscitation Inflammatory Response as Assessed by Serum Cytokine Levels (pg/mL).|Logarithm (base 10)-transformed serum levels of tumor necrosis factor alpha (TNFa), interleukin (IL)-1 beta, IL-6, IL-8, and IL-10; blood samples were obtained by venipuncture.|Time points of measurement: 4, 24, 48, and 72 hours postresuscitation.|At 4 hours after ROSC, reasons for missing data relative to total study population were 1) patient death within 4 hours after ROSC; and 2) non-adherence to protocol. Regarding the subsequent time points (i.e. 24, 48, and 72 hours), data was collected for <72 patients (Control, n=41), as additional patients died or some samples were not collected.|||Log(10) transformed values of pg/mL||Standard Error|Mean
2552718|NCT02790788|Secondary|Organ Failure-free Days.|Number of organ failure-free days during days 1 through 60 postrandomization. Organ failure free=corresponding Sequential Organ Failure Assessment Subscore <3; each subscore can have the following values: 0, 1, 2, 3, and 4; increasing values indicate worsening organ failure.|Days 1 to 60 postrandomization.||||Number of Days without Organ Failure||Inter-Quartile Range|Median
2552719|NCT02790788|Secondary|Cerebral Blood Flow Index by Near Infrared Spectroscopy With Indocyanine Green.|Results are reported for 2 pairs of cerebral blood flow index (CBFI) measurements performed each time at a lower and a higher level of mean arterial pressure (MAP) at the following time points: 1) at 4 hours after ROSC and 2) at 72 hours after ROSC|Time points of measurement: 4 and 72 hours postresuscitation.|Data were collected from 29 patients (Control, n=15). Reasons for missing data were 1) patient death within less than 72 hours after ROSC; 2) severe postresuscitation shock precluding changes in vasopressor infusion rates to achieve the desired MAP levels; and 3) technical issues with the near infrared spectroscopy equipment.|||nM/s||Standard Deviation|Mean
2552720|NCT02790788|Secondary|Core Body Temperature in Degrees Celcius.|Results are provided for core body temperature averaged over the following time intervals after ROSC: 1) 0-6 hours; 2) 6-12 hours; 3) 12-18 hours; 4) 18-24 hours; 5) 24-30 hours; 6) 30-36 hours; 7) 36-42 hours; and 42-48 hours.|Time points of measurement: Hourly from intensive care admission to 48 hours postresuscitation.|"For the first 6 hours after ROSC, data was collected from 74 patients (Controls, n=40); data was not collected from 26 patients (Controls, n=14), because of early death, or no temperature measurement. For the subsequent time intervals after ROSC, data could not be collected from all the aforementioned 74 patients, because some of them died."|||Degrees Celcius||Standard Deviation|Mean
2552814|NCT02787863|Secondary|Specific IgG Levels in Vaccinated Patients With COPD to S. Pneumoniae Serotypes|Mean specific IgG levels in vaccinated patients with COPD to S. pneumoniae serotypes at baseline, 6 and 12 months after vaccination|Baseline, 1 and 12 months after vaccination||||U/ml||Inter-Quartile Range|Median
2552721|NCT02790788|Secondary|Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.|Results are provided for CO at 72 hours after ROSC.|Time points of measurement: 72 hours after ROSC.|REASONS FOR MISSING DATA RELATIVE TO TOTAL STUDY POPULATION OF 100: 1) PATIENT DEATH WITHIN 72 HOURS AFTER ROSC; AND 3) ATTENDING PHYSICIAN OPINION THAT HE/SHE COULD EFFECTIVELY MANAGE THE PATIENT WITHOUT MONITORING OF CO.|||L/min||Standard Deviation|Mean
2552722|NCT02790788|Secondary|Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.|Results are provided for CO at 48 hours after ROSC|Time points of measurement: 48 hours after ROSC.|REASONS FOR MISSING DATA RELATIVE TO TOTAL STUDY POPULATION OF 100: 1) PATIENT DEATH WITHIN 48 HOURS AFTER ROSC; 2) PATIENT STILL NOT IN THE ICU; AND 3) ATTENDING PHYSICIAN OPINION THAT HE/SHE COULD EFFECTIVELY MANAGE THE PATIENT WITHOUT MONITORING OF CO.|||L/min||Standard Deviation|Mean
2552723|NCT02790788|Secondary|Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.|Results are provided for CO at 24 hours after ROSC.|Time points of measurement: 24 hours after ROSC.|REASONS FOR MISSING DATA RELATIVE TO TOTAL STUDY POPULATION OF 100: 1) PATIENT DEATH WITHIN 24 HOURS AFTER ROSC; 2) PATIENT STILL NOT IN THE ICU; AND 3) ATTENDING PHYSICIAN OPINION THAT HE/SHE COULD EFFECTIVELY MANAGE THE PATIENT WITHOUT MONITORING OF CO.|||L/min||Standard Deviation|Mean
2552724|NCT02790788|Secondary|Early Postresuscitation Cardiac Output (L/Min) Measured by Either Pulse Index Continuous Cardiac Output (PiCCO) or a Continuous Cardiac Output (CCO) Thermodilution Pulmonary Artery Catheter.|RESULTS ARE PROVIDED FOR CARDIAC OUTPUT (CO) AT 4 HOURS AFTER ROSC.|Time points of measurement: 4 hours after ROSC.|REASONS FOR MISSING DATA RELATIVE TO TOTAL STUDY POPULATION OF 100: 1) PATIENT DEATH WITHIN 4 HOURS AFTER ROSC; 2) PATIENT STILL NOT IN THE ICU; AND 3) ATTENDING PHYSICIAN OPINION THAT HE/SHE COULD EFFECTIVELY MANAGE THE PATIENT WITHOUT MONITORING OF CO.|||L/min||Standard Deviation|Mean
2552725|NCT02790788|Secondary|Eccentricity Index by Echocardiography.|"Eccentricity index (ECCI) is defined as the ratio of the left ventricular (LV) longitudinal (or anteroposterior) diameter to the LV transverse (or septo-lateral) diameter, measured at end diastole and end systole in a short-axis view. Pertinent results are provided for a first determination within 12 hours after ROSC and a second determination at 72 hours after ROSC."|Time points of measurement: Within the first 12 hours and at 72 hours postresuscitation.|Reasons for missing data relative to the total study population were 1) patient death within 72 hours after ROSC; and 2) non-adherence to protocol. Within 12 hours after ROSC, data were obtained from 43 patients (control, n=22). At 72 hours after ROSC, data could not be obtained from all the aforementioned patients, because some of them had died.|||ECCENTRICITY INDEX||Standard Deviation|Mean
2552726|NCT02790788|Secondary|Left and Right Ventricular Ejection Fraction (%) by Echocardiography.|Results are provided on left ventricular ejection fraction (LVEF) and right ventricular ejection fraction (RVEF) within 12 hours and 72 hours after ROSC.|Time points of measurement: Within the first 12 hours and at 72 hours postresuscitation.|Reasons for missing data relative to total population: 1) patient death within 72 hours after ROSC; and 2) non-adherence to protocol. At 72 hours after ROSC, data was not collected from some of the aforementioned patients due to death or because transesophageal echo for the measurement of RVEF was not repeated.|||Percentage||Standard Deviation|Mean
2552727|NCT02790788|Secondary|Left and Right Ventricular Diastolic Area (cm^2) by Echocardiography.|Results are provided on left ventricular end-diastolic area (LVEDA) and right ventricular diastolic area (RVEDA) by echocardiography within 12 hours and 72 hours after ROSC.|Time points of measurement: Within the first 12 hours and at 72 hours postresuscitation.|REASONS FOR MISSING DATA RELATIVE TO TOTAL POPULATION: 1) PATIENT DEATH; 2) NON-ADHERENCE TO PROTOCOL. RVEDA / LVEDA WAS MEASURED AT LEAST ONCE AT 12 / 72 HOURS POST-ROSC IN 42 PATIENTS (20 CONTROL, N=20). FOR EACH ONE OF THE 2 VARIABLES AND TIME POINTS, THE NUMBER OF PATIENTS STUDIED IS =< 22 FOR THE STEROIDS GROUP AND =< 20 FOR THE CONTROL GROUP.|||cm^2||Standard Deviation|Mean
2552728|NCT02790788|Primary|Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.|Results on postresuscitation central venous oxygen saturation (%) are provided for the fifth, pre-specified time point of measurement, i.e., at 72 hours after ROSC.|Time points of measurement: 72 hours after ROSC.|DATA COULD NOT BE COLLECTED FROM 19 PATIENTS OF THE STEROIDS GROUP AND FROM 24 PATIENTS OF THE CONTROL GROUP, EITHER BECAUSE OF PATIENT DEATH WITHIN LESS THAN 24 HOURS AFTER ROSC, OR BECAUSE THE ATTENDING INVESTIGATOR DID NOT COLLECT THE REQUIRED CENTRAL VENOUS BLOOD SAMPLE.|||Percent Hemoglobin Saturation||Standard Deviation|Mean
2552729|NCT02790788|Primary|Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.|Results on postresuscitation, mean arterial blood pressure (mmHg) are provided for the fifth, pre-specified time point of measurement, i.e. at 72 hours after ROSC.|Time points of measurement: 72 hours after ROSC.|DATA COULD NOT BE COLLECTED FROM 19 PATIENTS OF THE STEROIDS GROUP AND FROM 20 PATIENTS OF THE CONTROL GROUP, BECAUSE OF PATIENT DEATH WITHIN LESS THAN 72 HOURS AFTER ROSC.|||mmHg||Standard Deviation|Mean
2552730|NCT02790788|Primary|Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.|Results on postresuscitation central venous oxygen saturation (%) are provided for the fourth, pre-specified time point of measurement, i.e., at 48 hours after ROSC.|Time points of measurement: 48 hours after ROSC.|DATA COULD NOT BE COLLECTED FROM 18 PATIENTS OF THE STEROIDS GROUP AND FROM 22 PATIENTS OF THE CONTROL GROUP, EITHER BECAUSE OF PATIENT DEATH WITHIN LESS THAN 24 HOURS AFTER ROSC, OR BECAUSE THE ATTENDING INVESTIGATOR DID NOT COLLECT THE REQUIRED CENTRAL VENOUS BLOOD SAMPLE.|||Percent Hemoglobin Concentration||Standard Deviation|Mean
2552731|NCT02790788|Primary|Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.|Results on postresuscitation, mean arterial blood pressure (mmHg) are provided for the fourth, pre-specified time point of measurement, i.e. at 48 hours after ROSC.|Time points of measurement: 48 hours after ROSC.|DATA COULD NOT BE COLLECTED FROM 17 PATIENTS OF THE STEROIDS GROUP AND FROM 19 PATIENTS OF THE CONTROL GROUP, BECAUSE OF PATIENT DEATH WITHIN LESS THAN 48 HOURS AFTER ROSC.|||mmHg||Standard Deviation|Mean
2560609|NCT02662569|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2552732|NCT02790788|Primary|Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port.|Results on postresuscitation central venous oxygen saturation (%) are provided for the third, pre-specified time point of measurement, i.e., at 24 hours after ROSC.|Time points of measurement: 24 hours after ROSC.|DATA COULD NOT BE COLLECTED FROM 12 PATIENTS OF THE STEROIDS GROUP AND FROM 20 PATIENTS OF THE CONTROL GROUP, EITHER BECAUSE OF PATIENT DEATH WITHIN LESS THAN 24 HOURS AFTER ROSC, OR BECAUSE THE ATTENDING INVESTIGATOR DID NOT COLLECT THE REQUIRED CENTRAL VENOUS BLOOD SAMPLE.|||Percent Hemoglobin Concentration||Standard Deviation|Mean
2552733|NCT02790788|Primary|Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring.|Results on postresuscitation, mean arterial blood pressure (mmHg) are provided for the third, pre-specified time point of measurement, i.e. at 24 hours after ROSC.|Time points of measurement: 24 hours after ROSC.|DATA COULD NOT BE COLLECTED FROM 11 PATIENTS OF THE STEROIDS GROUP AND FROM 16 PATIENTS OF THE CONTROL GROUP, BECAUSE OF PATIENT DEATH WITHIN LESS THAN 24 HOURS AFTER ROSC.|||mmHg||Standard Deviation|Mean
2552734|NCT02790788|Primary|Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port (as Feasible).|Results on postresuscitation central venous oxygen saturation (%) are provided for the second, pre-specified time point of measurement, i.e., at 4 hours after ROSC.|Time points of measurement: 4 hours after ROSC.|DATA COULD NOT BE COLLECTED FROM 17 PATIENTS OF THE STEROIDS GROUP AND FROM 32 PATIENTS OF THE CONTROL GROUP, EITHER BECAUSE PATIENTS DIED WITHIN LESS THAN 4 HOURS AFTER ROSC, OR BECAUSE THEY STILL DID NOT HAVE A CENTRALVENOUS CATHETER IN-PLACE, OR BECAUSE THE ATTENDING INVESTIGATOR DID NOT COLLECT THE REQUIRED CENTRAL VENOUS BLOOD SAMPLE.|||Percent Hemoglobin Concentration||Standard Deviation|Mean
2552735|NCT02790788|Primary|Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).|Results on early postresuscitation, mean arterial blood pressure (mmHg) are provided for the second, pre-specified time point of measurement, i.e. at 4 hours after ROSC.|Time points of measurement: 4 hours after ROSC.|DATA COULD NOT BE COLLECTED FROM 7 PATIENTS OF THE STEROIDS GROUP AND FROM 7 PATIENTS OF THE CONTROL GROUP, BECAUSE THESE PATIENTS DIED WITHIN LESS THAN 4 HOURS AFTER ROSC.|||mmHg||Standard Deviation|Mean
2552736|NCT02790788|Primary|Early Postresuscitation Central Venous Oxygen Saturation (%) Measured in Blood Samples Obtained Through a Central Venous Catheter Port (as Feasible).|Results on early postresuscitation central venous oxygen saturation (%) are provided for the first, pre-specified time point of measurement, I.e., 20 min after the return of spontaneous circulation (ROSC). Actually, and exclusively for this particular measurement, reasons for the failure of consistent data collection are given below.|Time points of measurement: 20 min after ROSC.|DATA COULD NOT BE COLLECTED; REASON: A CENTRAL VENOUS BLOOD SAMPLE COULD NOT BE CONSISTENTLY OBTAINED AT 20 MIN AFTER RETURN OF SPONTANEOUS CIRCULATION, BECAUSE A CENTRAL VENOUS CATHETER WAS NOT IN PLACE ON MOST OCCASIONS; THE DATA MONITORING COMMITTEE RECOMMENDED THAT THIS SPECIFIC TIME POINT BE EXCLUDED FROM THE ANALYSIS.||||||
2552737|NCT02790788|Primary|Early Postresuscitation Arterial Blood Pressure (mmHg) Measured Through Institution of Invasive Intra-arterial Pressure Monitoring (as Feasible).|Results on early postresuscitation, mean arterial blood pressure (mmHg) are provided for the first, pre-specified time point of measurement, i.e. at 20 min after the return of spontaneous circulation (ROSC).|Time point of measurement: 20 min after the return of spontaneous circulation (ROSC).||||mmHg||Standard Deviation|Mean
2552738|NCT02790736|Secondary|Behavioral Avoidance Task|Up to 5 sequential public speaking challenges, specifically designed for each step to be of increasing difficulty for the individual. Each step is considered completed if subject agrees to try speaking, and speaks for 1 minute. Score is total number of completed steps (0-5) on this 5-step task, with 5 being best|2 weeks||||steps||Full Range|Mean
2552739|NCT02790736|Primary|Personal Report of Confidence as a Speaker|total score on this self report measure of fear of public speaking. Scored from 0-30, with higher scores indicating better outcome|2 weeks||||score on a scale||Full Range|Mean
2552740|NCT02790606|Secondary|Endpoint Without Hypothesis Testing: Number of Participants With Procedure Success|Procedure Success is defined as anatomic success and resolution of the pre-procedural clinical indicator(s) (clinical success) of a hemodynamically significant stenosis.|At time of index procedure|Procedure Success (All Treated Subjects)|||Participants|||Count of Participants
2552741|NCT02790606|Secondary|Endpoint Without Hypothesis Testing: Number of Participants With Technical Success (for Stent Graft Placement)|Technical Success is defined as successful deployment, based on the operator's opinion, of the implant to the intended location assessed at the time of the index procedure.|At time of index procedure|Number of Participants with Acute Technical Success (All Treated Subjects)|||Participants|||Count of Participants
2552742|NCT02790606|Secondary|Endpoint Without Hypothesis Testing: Number of Participants With Post-intervention Secondary Patency|"Secondary Patency is defined as the interval after the index intervention until the access is abandoned. Multiple repetitive treatments can be included in post-intervention secondary patency.~The 1, 3, 6, 12, 18 and 24 months final results are reported below."|1, 3, 6, 12, 18 and 24 months post index procedure|"Post-Intervention Secondary Patency by Follow-Up Period (All Treated Subjects).~(n) varies in relation to the number of failures (access abandonment) recorded at 30 days, 90 days and 6 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section."|||Participants|||Count of Participants
2552750|NCT02790606|Primary|Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency|"Target Lesion Primary Patency (TLPP) is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site or until the extremity is abandoned for permanent access.~Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV access graft due to inability to treat the original treatment area.~The primary effectiveness endpoint is evaluated against a performance goal (PG) of 40%."|6 months post index procedure|"Number of participants with Target Lesion Primary Patency.~In total, nine (9) subjects were excluded from the denominator (110) due to discontinuation or abandonment of their index AV access circuit for non effectiveness reasons prior to Day 150 of their follow-up. Therefore, the Overall Number of Participants analyzed is 101 for this measure."|||Participants|||Count of Participants
2552743|NCT02790606|Secondary|Endpoint Without Hypothesis Testing: Index of Patency Function - Target Lesion (IPF-T)|"IPF-T (Index of Patency Function - Target Lesion) is defined as the time from the index study procedure to study completion or complete access abandonment divided by the number of visits for a reintervention performed at the target lesion in order to maintain vascular access for hemodialysis.~The 1, 3, 6, 12, 18 and 24 months final results are reported below.~The IPF for target lesion patency is representative of the approximate (mean) number of days between interventions to maintain target lesion patency. The minimum and maximum ranges for the Index of Patency Function are as follows: 1 month (6.3 - 30.0); 3 months (6.3 - 90.0); 6 months (6.3 - 180.0); 12 months (6.3 - 365.0); 18 months (6.3 - 545.0); and 24 months (6.3 - 730.0). Higher values represent a better outcome, that is, more time elapsed between the Index study procedure and reinterventions."|1, 3, 6, 12, 18 and 24 months post index procedure|Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 3 months and 6 months follow-up or did not meet endpoint inclusion criteria.|||Index||Standard Deviation|Mean
2552744|NCT02790606|Secondary|Endpoint Without Hypothesis Testing: Index of Patency Function (IPF)|"IPF is defined as the time from the index study procedure to study completion or access abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis.~The 1, 3, 6, 12, 18 and 24 months final results are reported below.~The IPF is representative of the number of days between interventions to maintain access circuit patency. The minimum and maximum ranges for the Index of Patency Function are as follows: 1 month (6.3 - 30.0); 3 months (6.3 - 90.0); 6 months (6.3 - 180.0); 12 months (6.3 - 365.0); 18 months (6.3 - 545.0); and 24 months (6.3 - 730.0). Higher values represent a better outcome, that is, more time elapsed between the Index study procedure and reinterventions."|1, 3, 6, 12, 18 and 24 months post index procedure|Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 3 months and 6 months follow-up or did not meet endpoint inclusion criteria.|||Index||Standard Deviation|Mean
2552745|NCT02790606|Secondary|Endpoint Without Hypothesis Testing: Total Number of Target Lesion Reinterventions|"Total Number of Target Lesion Reinterventions defined as the number of reinterventions to maintain target lesion patency.~The 1, 3, 6, 12, 18 and 24 months final results are reported below."|1, 3, 6, 12, 18 and 24 months post index procedure|"The (n) in each follow-up periods vary from overall enrollment (N) as some subjects discontinued participation before each follow-up or did not meet endpoint inclusion criteria.~The total number of Reinterventions by Follow-Up Period was analyzed as opposed to the number of subjects with at least one AV Target Lesion Reintervention."|||Target Lesion Reinterventions|||Number
2552746|NCT02790606|Secondary|Endpoint Without Hypothesis Testing: Total Number of Arteriovenous (AV) Access Circuit Reinterventions|"Total Number of AV Access Circuit Reinterventions defined as the number of reinterventions to the AV access circuit until access abandonment or through study completion.~The 1, 3, 6, 12, 18 and 24 months final results are reported below."|1, 3, 6, 12, 18 and 24 months post index procedure.|Total number of AV Access Circuit Reinterventions by Follow-Up Period. The number for a specific period may be higher than the number of subjects with at least one AV access reintervention in that period. Number of participants (n) varies from overall enrollment (N) due to discontinued participation or not meeting endpoint inclusion criteria.|||AV Access Reinterventions|||Number
2552747|NCT02790606|Secondary|Endpoint Without Hypothesis Testing: Number of Participants With Device and Procedure Related AEs Involving the AV Access Circuit|"Number of Participants with device and procedure related Adverse Events involving the AV access circuit.~The access circuit is the area from the arterial inflow to the SVC-right atrial junction.~The 1, 3, 6, 12, 18 and 24 months final results are reported below."|1, 3, 6, 12, 18 and 24 months post index procedure,|"Number of Participants Free from Device/Procedure-Related Adverse Events.~Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 3 months and 6 months follow-up or did not meet endpoint inclusion criteria."|||Participants|||Count of Participants
2552748|NCT02790606|Secondary|Endpoint With Hypothesis Testing: Number of Participants With Access Circuit Primary Patency (ACPP)|"ACPP is defined as the interval following the index intervention until the next access thrombosis or repeated intervention.~ACPP ends with a reintervention anywhere within the access circuit. Vessel rupture caused by PTA is not an ACPP failure unless achieving hemostasis also causes thrombosis.~The 1, 3, 6, 12, 18 and 24 months final results are reported below."|1, 3, 6, 12, 18 and 24 months post index procedure|"Number of Participants with Access Circuit Primary Patency (ACPP).~Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 3 months and 6 months follow-up or did not meet endpoint inclusion criteria."|||Participants|||Count of Participants
2552749|NCT02790606|Secondary|Endpoint Without Hypothesis Testing: Number of Participants With Target Lesion Primary Patency (TLPP)|"TLPP is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site or until the extremity is abandoned for permanent access.~Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV access graft due to inability to treat the original treatment area.~The 1, 3, 6, 12, 18 and 24 months final results are reported below."|1, 3, 6, 12, 18 and 24 months post index procedure|"Number of Participants with Target Lesion Primary Patency.~Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 3 months and 6 months follow-up or did not meet endpoint inclusion criteria."|||Participants|||Count of Participants
2552751|NCT02790606|Primary|Number of Participants With Freedom From AV Access Circuit Localized or Systemic Serious Adverse Events|Safety is defined as freedom from any adverse event(s) (AEs), localized or systemic, that reasonably suggests the involvement of the AV access circuit (not including stenosis or thrombosis) that require or result in any of the following alone or in combination: additional interventions (including surgery); in-patient hospitalization or prolongation of an existing hospitalization; or death.|30 days post index procedure|Number of Participants Free from Primary Safety Events (All Treated Subjects)|||Participants|||Count of Participants
2552752|NCT02790463|Primary|Adherence to Medication|Adherence to prescribed medication|12 months||||Participants|||Count of Participants
2552757|NCT02790073|Secondary|Wound-QoL Global Score|"Absolute change from baseline (Week 1) and Week 12 in the Wound-QoL global score.~The Wound-QoL questionnaire measures the disease-specific, health related QoL of patients with chronic wounds. It consists of 17 items on impairments that are assessed in retrospect to the preceding 7 days and rated on a 0 (best) to 4 (worse) scale with possible responses from not at all to very much. The total score is the average of the 17 responses."|12 weeks|Subjects who received at least 1 dose of SNF472 and had at least 1 postbaseline efficacy measurement|||units on a scale||Standard Deviation|Mean
2552758|NCT02790073|Secondary|Wound Pain|"Absolute change from baseline (Week 1) and Week 12 in the Pain Visual Analogue Scale (VAS) Score.~The Pain Visual Analogue Scale (VAS) Score is a horizontal line, 100 mm in length, anchored by word descriptors at each end. The subject marked the point on the line that represented his/her perception of his/her current pain status. The Pain Visual Analogue Scale (VAS) Score was determined by measuring in millimeters from the left hand end of the line (no pain) to the point that the subject marked. The Pain Visual Analogue Scale (VAS) Score range 0 (best) to 100 (Worst)."|12 weeks|Subjects who received at least 1 dose of SNF472 and had at least 1 postbaseline efficacy measurement|||units on a scale||Standard Deviation|Mean
2552759|NCT02790073|Primary|Wound Healing|"Absolute change in Bates-Jensen Wound Assessment (BWAT) total score between baseline (Week 1) and Week 12 for the primary lesion (the largest one).~The Bates-Jensen Wound Assessment (BWAT) is a standardized tool for quantitative assessment of wound healing that includes the 13 items listed below.~Size~Depth~Edges~Undermining or pockets~Necrotic tissue type~Necrotic tissue amount~Exudate type~Exudate amount~Surrounding skin color~Peripheral tissue edema~Peripheral tissue induration~Granulation tissue~Epithelialization~Each item was rated on a scale of 1 (best) to 5 (worst). The Bates-Jensen Wound Assessment (BWAT) total score is the sum of the individual items with a possible range of 13 (best) to 65 (worst)."|12 weeks|Subjects who received at least 1 dose of SNF472 and had at least 1 postbaseline efficacy measurement|||units on a scale||Standard Deviation|Mean
2552760|NCT02789410|Secondary|Pruritus|The number of subjects who experienced and self-reported pruritus within the first 24 hours after administration of spinal anesthesia.|24 hours after administration of spinal anesthesia||||Participants|||Count of Participants
2552761|NCT02789410|Secondary|Nausea|The number of subjects who experienced and self-reported nausea within the first 24 hours after administration of spinal anesthesia.|24 hours after administration of spinal anesthesia||||Participants|||Count of Participants
2552762|NCT02789410|Primary|NRS Score for Pain (0-10) With Movement 24 Hours After Spinal Administration|Each patient will be interviewed by a member of the study team 24 hours after receiving their spinal anesthetic. Patients will be asked to rate their current level of pain on a Numeric Rating Scale (NRS) of 0 (no pain) to 10 (worst pain imaginable).|24 hours after administration of spinal anesthesia||||score on a scale||Inter-Quartile Range|Median
2552763|NCT02788747|Secondary|Change in Mitral Regurgitation Severity (cm2)|Change in Mitral Regurgitation Severity as measured by cm2 from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.|Baseline to Week 4|All participants for whom Mitral Regurgitation Severity was measured at baseline and Week 4|||cm2||Standard Deviation|Mean
2552764|NCT02788747|Secondary|Change in Right Ventricular Systolic Pressure (mmHg)|Change in Change in Right Ventricular Systolic Pressure as measured by mmHg from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.|Baseline to Week 4|All participants for whom Right Ventricular Systolic Pressure was measured at baseline and Week 4|||mmHg||Standard Deviation|Mean
2552765|NCT02788747|Secondary|Change in Right Ventricular Fractional Area (%)|Change Right Ventricular Fractional Area in as measured by percentage from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.|Baseline to Week 4|All participants for whom Right Ventricular Fractional Area was measured at baseline and Week 4|||percentage of area||Standard Deviation|Mean
2552766|NCT02788747|Secondary|Change in Tricuspid Regurgitation Severity Assessment (cm2)|Change in Tricuspid Regurgitation Severity Assessment as measured by cm2 from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.|Baseline to Week 4|All participants for whom Tricuspid Regurgitation Severity Assessment was measured at baseline and Week 4|||cm2||Standard Deviation|Mean
2552767|NCT02788747|Secondary|Left Ventricular Mass Assessment (g)|Change in Left Ventricular Mass Assessment as measured by grams from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.|Baseline to Week 4|All participants for whom Left Ventricular Mass was measured at baseline and Week 4|||grams||Standard Deviation|Mean
2552768|NCT02788747|Secondary|Change in Biplane Ejection Fraction (mL)|Change in Biplane Ejection Fraction as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.|Baseline to Week 4|All participants for whom Biplane Ejection Fraction was measured at baseline and Week 4|||mL||Standard Deviation|Mean
2552769|NCT02788747|Secondary|Change in Left Ventricular End Systolic Volume (mL) as Measured by Echocardiography|Change in Left Ventricular End Systolic Volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.|Baseline to Week 4|All participants for whom Left Ventricular End Systolic Volume was measured at baseline and Week 4|||mL||Standard Deviation|Mean
2552770|NCT02788747|Secondary|Change in Left Ventricular End Diastolic Volume (mL) as Measured by Echocardiography|Change in Left Ventricular End Diastolic Volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.|Baseline to Week 4|All participants for whom Left Ventricular End Diastolic Volume was measured at baseline and Week 4|||mL||Standard Deviation|Mean
2552771|NCT02788747|Secondary|Change in Left Ventricular Global Longitudinal Strain Assessment (%)|Change in Left Ventricular Global Longitudinal Strain Assessment as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.|Baseline to Week 4|All participants for whom Left Ventricular Global Longitudinal Strain Assessment was measured at baseline and Week 4|||percentage||Standard Deviation|Mean
2552815|NCT02787863|Secondary|CD45RO|CD45RO expression on lymphocytes in serum at baseline, 1 and 4 years after vaccination. These patients were selected from patients of the main groups.|Baseline, 1 and 4 years after vaccination||||U||Standard Deviation|Mean
2552773|NCT02788747|Secondary|Change in Early Mitral Inflow Velocity and Mitral Annular Early Diastolic Velocity Ratio (E/e')|Change in Early Mitral Inflow Velocity and Mitral Annular Early Diastolic Velocity Ratio as measured by E/e' from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.|Baseline to Week 4|All participants for whom Early Mitral Inflow Velocity and Mitral Annular Early Diastolic Velocity Ratio was measured at baseline and Week 4|||ratio||Standard Deviation|Mean
2552774|NCT02788747|Secondary|Change in Early and Late Mitral Inflow Velocity Ratio|Change in Early and Late Mitral Inflow Velocity Ratio from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by echocardiography.|Baseline to Week 4|All participants for whom Early and Late Mitral Inflow Velocity Ratio was measured at baseline and Week 4|||ratio||Standard Deviation|Mean
2552775|NCT02788747|Secondary|Change in Right Ventricular Ejection Fraction (% Blood Volume)|Change in Right Ventricular Ejection Fraction as measured by percentage of blood volume from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.|Baseline to Week 4|All participants for whom Right Ventricular Ejection Fraction was measured at baseline and Week 4|||percentage of blood volume||Standard Deviation|Mean
2552776|NCT02788747|Secondary|Change in Right Ventricular End Diastolic Volume (mL)|Change in Right Ventricular End Diastolic Volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.|Baseline to Week 4|All participants for whom Right Ventricular End Diastolic Volume was measured at baseline and Week 4|||mL||Standard Deviation|Mean
2552777|NCT02788747|Secondary|Change in Right Ventricular End Systolic Volume (mL)|Change in Right Ventricular End Systolic Volume as measured by mL from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.|Baseline to Week 4|All participants for whom Right Ventricular End Systolic Volume was measured at baseline and Week 4|||mL||Standard Deviation|Mean
2552778|NCT02788747|Secondary|Change in Left Ventricular Myocardial Mass (g)|Change in Left Ventricular Myocardial Mass as measured by grams from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.|Baseline to Week 4|All participants for whom Left Ventricular Myocardial Mass was measured at baseline and Week 4|||grams||Standard Deviation|Mean
2552779|NCT02788747|Secondary|Change in Left Ventricular Cardiac Output (L/Min)|Change in Left Ventricular Cardiac Output as measured by L/min from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.|Baseline to Week 4|All participants for whom Left Ventricular Cardiac Output was measured at baseline and Week 4|||L/min||Standard Deviation|Mean
2552780|NCT02788747|Secondary|Change in Left Ventricular Stroke Volume (ml)|Change in Left Ventricular Stroke Volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.|Baseline to Week 4|All participants for whom Left Ventricular Stroke Volume was measured at baseline and Week 4|||mL||Standard Deviation|Mean
2552781|NCT02788747|Secondary|Change in Left Ventricular End Diastolic Volume (ml) as Measured by MRI|Change from baseline in Left Ventricular End Diastolic Volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.|Baseline to Week 4|All participants for whom Left Ventricular End Diastolic Volume was measured at baseline and Week 4|||mL||Standard Deviation|Mean
2552782|NCT02788747|Secondary|Change in Left Ventricular Ejection Fraction (% of Blood Volume)|Change in Left Ventricular Ejection Fraction as measured by percentage of blood volume from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.|Baseline to Week 4|All participants for Left Ventricular Ejection Fraction was measured at baseline and Week 4|||percentage of blood volume||Standard Deviation|Mean
2552783|NCT02788747|Primary|Change in Left Ventricular End Systolic Volume (ml)|Change in left ventricular end systolic volume as measured by ml from baseline (last assessment prior to start of study) to Week 4 (end of treatment visit) as assessed by MRI.|Baseline to Week 4|All participants for whom left ventricular end systolic volume was measured at baseline and Week 4|||mL||Standard Deviation|Mean
2552784|NCT02788656|Other Pre-specified|Mean Change in Total Daily Diuretic Dose While on Sacubitril/Valsartan|Mean change in total daily diuretic dose while on sacubitril/valsartan (32 weeks)|Baseline, 32 weeks (testing performed at intervals during study)|** Data not reported as too few participants were enrolled for meaningful analysis (n=4)||||||
2552785|NCT02788656|Other Pre-specified|The Relationship of Change in PAPm to Change in the Questions in the Kansas City Cardiomypathy Questionnaire (KCCQ) 3,7,8,9|Correlation between change in PAPm and change in KCCQ at 32 weeks|Baseline, 32 weeks (testing performed at intervals during study)|Not reported due to lack of adequate data (too few participants enrolled)||||||
2552786|NCT02788656|Secondary|Change in NT-proBNP|Change in NT-proBNP from baseline to 6 weeks|Baseline||||pg/mL||Full Range|Mean
2552787|NCT02788656|Secondary|Determine the Change in Distance Walked During a Standard 6 Minute Walk Test From Baseline|Change in 6 minute walk distance in Group A vs. Group B at 6 weeks|Baseline, 6 weeks||||m||Full Range|Mean
2552788|NCT02788656|Secondary|The Difference Between Mean Change in PAPm From Baseline on Sacubitril/Valsartan Compared to ACEI/ARB|Change in PAPm on sacubitril/valsartan: Measured from baseline to week 6 (group A) and week 7-week 12 (Group B)|6 weeks (week 1-6 of the study for group A, weeks 7-12 for group B)||||mm Hg||Full Range|Mean
2552789|NCT02788656|Secondary|Mean Change in PAPm in Both Groups on Sacubitril/Valsartan|Change in PAPm from week 12-32|20 weeks (weeks 12 to 32 of the study)||||mm Hg||Full Range|Mean
2552790|NCT02788656|Primary|The Acute Change in PAPm After the First Administration of Sacubitril/Valsartan|Change in PAPm at 3 hours|Baseline, 3 hours (after first dose of sacubitril/valsartan)||||mm Hg||Full Range|Mean
2552791|NCT02788656|Primary|Difference Between Mean Change in Mean Pulmonary Artery Pressure (PAPm) With Sacubitril/Valsartan Compared to the Mean Change in PAPm With Continued ACEi/ARB|Change in mean PAP in group A versus group B|Baseline, 6 weeks||||mm Hg||Full Range|Mean
2552833|NCT02787551|Secondary|Change From Baseline in Body Weight at Week 26: Core Period|Change in body weight was calculated by subtracting baseline value from Week 26 value.|Baseline, Week 26|"Analysis was performed using mITT population. Here, overall number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment."|||kilogram (kg)||Standard Error|Least Squares Mean
2552792|NCT02788474|Secondary|The Rate of Change in Blood Collagen 3 Degraded by Matrix Metalloproteinase-9 (C3M) From Baseline to Week 12|"The rate of change in blood Collagen 3 degraded by matrix metalloproteinase-9 (C3M) from baseline to week 12 is presented.~The mean presented is the adjusted rate based on a random coefficient regression (C3M- log 10 transformation) with fixed effects for gender, age, height and random effect of patient specific intercept and time."|baseline and 12 weeks|Treated set (TS) including participants with available data for this endpoint.|||ng/ml/mth||Standard Error|Mean
2552793|NCT02788474|Secondary|The Rate of Change in Blood Collagen 1 Degraded by Matrix Metalloproteinase-2/9/13 (C1M) From Baseline to Week 12|"The rate of change in blood Collagen 1 degraded by matrix metalloproteinase-2/9/13 (C1M) from baseline to week 12 is presented.~The mean presented is the adjusted rate based on a random coefficient regression (C1M (negative reciprocal root transformation)) with fixed effects for gender, age, height and random effect of patient specific intercept and time."|baseline and 12 weeks|Treated set (TS) including participants with available data for this endpoint.|||ng/ml/mth||Standard Error|Mean
2552794|NCT02788474|Secondary|Percentage of Patients With Disease Progression as Defined by Absolute Forced Vital Capacity (FVC) Decline >=10% or Death Until Week 52|"For this endpoint, disease progression was defined by absolute FVC (percentage of predicted) decline ≥10% or death up to Week 52 based on in-clinic supervised spirometry.~This is a key secondary endpoint of the trial. This outcome measure is percentage of patients with disease progression and CRPM is included in the various models as a factor/covariate, and that this outcome measure, the percentage of progressors are displayed under Measured values"|52 weeks|Treated set|||Percentage of participants||95% Confidence Interval|Number
2552795|NCT02788474|Primary|The Rate of Change (Slope) in Blood C-reactive Protein Degraded by Matrix Metalloproteinase-1/8 (CRPM) From Baseline to Week 12.|The rate of change (slope) in blood C-reactive protein degraded by matrix metalloproteinase-1/8 (CRPM) from baseline to week 12 is presented. The mean presented is the adjusted rate based on a random coefficient regression (CRPM log 10 transformed) with fixed effects for gender, age, height and random effect of patient specific intercept and time.|baseline and 12 weeks|Treated set (TS) including participants with available data for this endpoint.|||nanogram/ millitre/ month (ng/ mL/ mth)||Standard Error|Mean
2552796|NCT02788357|Secondary|Transcranial Magnetic Stimulation||Score change after 10 days of intervention compared to baseline; Score change after 1-month after the intervention compared to baseline|This data is not available at this time, as a relocation occurred during the project. Data collected at the previous institution used different software and stored the data in a different format than is currently used. Therefore, reconciliation of this data is being attempted at this time.||||||
2552797|NCT02788357|Secondary|Change in Wolf Motor Function Test (WMFT)|Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. Each task is scored as amount of time taken to complete a task, which may range from just over 0 to 120 seconds. If the subject is unable to complete the task within 120 seconds, a score of 121 seconds is given. The scores from the 15 individual tasks are averaged, then the log is taken, resulting in the overall score. Therefore, the larger the score, the longer required to perform the tasks. Negative changes in score indicate that a subject, on average, was able to complete the tasks faster at post-intervention or at 1-month follow-up than at baseline.|baseline, post-intervention, 1-month follow-up|3 subjects in the Atomoxetine group were lost to follow-up.|||log(seconds)||95% Confidence Interval|Mean
2552798|NCT02788357|Secondary|Change in Action Arm Research Test (ARAT)|Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. The score is calculated by summing the scores for 19 individual tasks. The possible scores range from 0 to 57, with higher scores indicating better performance.|baseline, post-intervention, 1-month follow-up|3 subjects in the Atomoxetine group were lost to follow-up.|||units on a scale||95% Confidence Interval|Mean
2552799|NCT02788357|Primary|Change in Fugl Meyer Assessment|Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.|baseline, post-intervention, 1-month follow-up|3 subjects in Atomoxetine group were lost to follow-up.|||units on a scale||95% Confidence Interval|Mean
2552800|NCT02788279|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab||Pre-infusion (0 hours) on Day 1 of Cycles 1 to 4, 8, and every 8 cycles thereafter; at treatment discontinuation; 120 days after treatment discontinuation (up to approximately 2.5 years) (1 cycle = 28 days)|Analysis was performed on the SAF population and included participants with at least one predose and one postdose ATA assessment.|||percentage of participants|||Number
2552801|NCT02788279|Secondary|Serum Concentration of Atezolizumab|Pre-infusion (0 hours) on Day 1 of Cycles 1 to 4; 30 minutes post-infusion on Day 1 of Cycles 1 and 4; pre-infusion (0 hours) on Day 1 of Cycle 8 and every 8 cycles thereafter; at treatment discontinuation; 120 days after treatment discontinuation (up to approximately 2.5 years) (1 cycle = 28 days)|Pre-infusion (0 hours) on Day 1 of Cycle 1 up to approximately 2.5 years. Detailed time frame is explained in the outcome measure description field.|The pharmacokinetic (PK) evaluable population included all participants who received any dose of study medication and who had at least one post-baseline PK sample available. Also, only included participants to whom Atezolizumab was administered.|||microgram/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2552802|NCT02788279|Secondary|Plasma Concentration of Cobimetinib||Predose (0 hours) and 3 to 6 hours after dose on Day 15 of Cycles 1 and 4 (1 cycle = 28 days) (up to approximately 2.5 years).|The pharmacokinetic (PK) evaluable population included all participants who received any dose of study medication and who had at least one post-baseline PK sample available. Only included participants in the Cobimetnib arm|||Nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2552803|NCT02788279|Secondary|Percentage of Participants With Adverse Events (AEs)||Baseline, end of the study (up to approximately 2.5 years)|Analysis was performed on the SAF population.|||percentage of participants|||Number
2552831|NCT02787551|Secondary|Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Core Period|Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of <3.0 mmol/L (54 mg/dL) were also analyzed.|From Baseline to Week 26|Analysis was performed on safety population which included all randomized participants who received at least one dose of open-label IMP, regardless of the amount of treatment administered. Participants were analyzed according to the treatment actually received (as treated).|||events per participant-year|||Number
2552804|NCT02788279|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life-C30 Questionnaire (EORTC QLQ-C30) Global Quality of Life Sub-scale Score at the End of the Study|The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.|Baseline, end of the study (up to approximately 2.5 years)|Analysis was performed on PRO-evaluable population. Here, 'Overall Number of Participants Analyzed’ signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time point.|||units of a scale||Standard Deviation|Mean
2552805|NCT02788279|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life-C30 Questionnaire (EORTC QLQ-C30) Physical Functioning Sub-scale Score|The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.|Baseline, end of the study (up to approximately 2.5 years)|Analysis was performed on PRO-evaluable population. Here, 'Overall Number of Participants Analyzed’ signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time point.|||units of a scale||Standard Deviation|Mean
2552806|NCT02788279|Secondary|Duration of Response (DOR) According to RECIST Version 1.1|DOR is defined as the period measured from the date of the first occurrence of a CR or PR (whichever status is recorded first) until the first date that progressive disease or death is documented. Disease progression was determined on the basis of investigator assessment with use of RECIST v1.1. Median DOR was estimated using the Kaplan-Meier method, and the 95% CI was calculated using the method of Brookmeyer and Crowley.|From first occurrence of CR or PR up to disease progression or death due to any cause (up to approximately 20 months)|DOR was assessed in participants who had an objective response during the study.|||months||95% Confidence Interval|Median
2552807|NCT02788279|Secondary|Percentage of Participants With Investigator-Assessed Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST Version 1.1|PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). Objective response and its 95% CI were calculated using the Clopper-Pearson method.|From randomization up to death due to any cause (up to approximately 20 months)|Analysis was performed on evaluable participants in the ITT population with measurable disease at baseline, as determined by the investigator.|||percentage of participants||95% Confidence Interval|Number
2552808|NCT02788279|Secondary|Progression-Free Survival (PFS) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|From randomization up to disease progression or death due to any cause (up to approximately 20 months)|Analysis was performed on the ITT population.|||months||95% Confidence Interval|Median
2552809|NCT02788279|Primary|Overall Survival (OS)|Overall survival is defined as the time (in months) between the date of randomization and the date of death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|From randomization up to death due to any cause (up to approximately 20 months)|Analysis was performed on the ITT population.|||months||95% Confidence Interval|Median
2552810|NCT02788188|Primary|Number of Participants Having Adverse Events|Number of participants who experienced an adverse event|90 days|Number of participants who completed both treatment and placebo|||Participants|||Count of Participants
2552811|NCT02788175|Secondary|Number of Subjects Who Met Criteria to Restart Antiretroviral Therapy Before Week 48|The secondary endpoint was defined as number of subjects who experienced plasma viremia following ATI and met criteria to restart cART before week 48 [a confirmed >30% decline in baseline CD4+ T Cell count or an absolute CD4+ T Cell count in the setting of detectable HIV viremia (>40 copies/mL); a sustained (>4weeks) HIV RNA level of > 1000 copies/mL, or any HIV related symptoms or pregnancy.]|From Week 22 until up to 48 weeks.|The analyses includes all subjects who entered into the analytical treatment interruption at Week 22|||Participants|||Count of Participants
2552812|NCT02788175|Primary|Number of Grade 2 or Higher Related Adverse Events|The primary endpoint was the number of grade 2 or higher adverse events, including serious adverse events, that were probably or definitely related to vedolizumab.|From the start of the initial infusion until up to 72 weeks.|The analyses included all subjects who received at least one infusion of vedolizumab|||Events|||Number
2552813|NCT02788097|Primary|Biochemical Pregnancy|>30IU/L of serum βhCG on day 14 of cycle|1 year||||percentage of participants|||Number
2560610|NCT02662569|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12||Baseline and week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2552816|NCT02787863|Secondary|IgA, IgM, IgG, IgE, Circulating Immune Complexes (CIC)|"IgA, IgM, IgG, IgE, circulating immune complexes (CIC) in serum at baseline, 1, 2 and 6 weeks after vaccination. It was pre-specified to report data from only the COPD - Prevenar-13 and the COPD - Pneumo-23 Arms/Groups for this Outcome Measure. This is due to the fact that we tried to study the effect of PCV13 and PPV23 on immunity values. The study of the immunological effects of vaccination in the early post-vaccination period was carried out in 2 groups of patients: 20 patients with COPD vaccinated with PCV13; 20 patients with COPD vaccinated with PPV23. These patients were selected from patients of the main groups (COPD - Prevenar-13 (1), COPD - Pneumo-23 (3))."|Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination in COPD||||g/l||Standard Deviation|Mean
2552817|NCT02787863|Secondary|Immunophenotype of Blood Lymphocytes in Patients With COPD|"Immunophenotype of blood lymphocytes in patients with COPD at baseline, 1, 2 and 6 weeks after PCV13 and PPV23 vaccination. It was pre-specified to report data from only the COPD - Prevenar-13 and the COPD - Pneumo-23 Arms/Groups for this Outcome Measure. This is due to the fact that we tried to study the effect of PCV13 and PPV23 on immunity values. The study of the immunological effects of vaccination in the early post-vaccination period was carried out in 2 groups of patients: 20 patients with COPD vaccinated with PCV13; 20 patients with COPD vaccinated with PPV23. These patients were selected from patients of the main groups (COPD - Prevenar-13 (1), COPD - Pneumo-23 (3))."|Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination|CD3+, CD3+CD4+, CD3+CD8+, CD19+, CD3-CD16+CD56+, CD3+CD16+CD56+, CD3-HLA DR+, CD3+HLA DR+|||% of cells||Standard Deviation|Mean
2552818|NCT02787863|Secondary|Phagocytic Activity in Patients With COPD at Baseline, 1, 2, and 6 Weeks After PCV13 and PPV13 Vaccination|"Phagocytic index (granulocytes), phagocytic index (monocytes), activity of a spontaneous HCT test (neutrophils), activity of an induced HCT test (neutrophils), percentage of HCT-positive white blood cells in a spontaneous test. The phagocytic index was calculated according to the following formula: phagocytic index = (total number of engulfed cells/total number of counted macrophages) × (number of macrophages containing engulfed cells/total number of counted macrophages) × 100 (phagocytic index)~The phagocytic index was calculated by counting at least 100 bacteria phagocytized by certain number of phagocytic cells/macrophages and expressed following formula (Mamnur Rashid 1997):~Phagocytic index = Total no. of phagocytized bacteria /No of phagocytic cells phagocytizing bacteria.~Activation index = % formazan positive cells (FPC) in NBT stimulated / % formazan positive cells (FPC) in NBT Spontaneous."|Baseline, 1, 2, 6 weeks after PCV13 and PPV13 vaccination|Phagocytic index (granulocytes) — %, phagocytic index (monocytes) — %, activity of a spontaneous HCT test (neutrophils) — %, activity of an induced HCT test (neutrophils) — %, percentage of HCT-positive white blood cells in a spontaneous test — %.|||score on a scale||Standard Deviation|Mean
2552819|NCT02787863|Secondary|Average CAT (COPD) and ACQ-5 (Asthma) Score|"CAT — COPD Assessment Test, min. = 0, max. = 40, higher scores mean a worse outcome.~ACQ-5 — Asthma control questionnaire, min. = 0, max. = 6, higher scores mean a worse outcome."|Baseline, after 1 and 4 years after vaccination||||score on a scale||Inter-Quartile Range|Median
2552820|NCT02787863|Secondary|Seeding Frequency S. Pneumoniae From Sputum in Patients With COPD|Seeding frequency S. pneumoniae from sputum in patients with COPD|Baseline, after 1 and 4 years after vaccination||||Number of Participants with S. Pneumonia|||Number
2552821|NCT02787863|Primary|The Number of Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation|The number of exacerbations of the underlying disease, antibiotic use and hospitalisation. The average number of exacerbations per 1 patient = total exacerbations in the group / number of patients in the group. This is not a mean value.|Baseline (1 year prior to vaccination), 1 year after vaccination, 4 years after vaccination||||Events per 1 patient|||Number
2552822|NCT02787863|Primary|Number of Patients Without Exacerbations of the Underlying Disease, Antibiotic Use and Hospitalisation.|Number of patients without exacerbations of the underlying disease, antibiotic use and hospitalisation.|Baseline (1 year prior to vaccination), 1 year after vaccination, 4 years after vaccination||||Participants|||Count of Participants
2552823|NCT02787694|Primary|10 m Walk Test|Overground 10 meter walk test consisting of three trials administered at baseline (pre-intervention) and at 10 weeks (post-intervention).|Baseline (pre-intervention) and 10 weeks (post-intervention)||||m/s||Standard Deviation|Mean
2552824|NCT02787564|Secondary|Amount of Fruits and Vegetables Among Non-Food Bank Users|Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks among non-Food Bank Users.|baseline and 4 weeks||||portions/day||Standard Deviation|Mean
2552825|NCT02787564|Secondary|Variety of Fruits and Vegetables Among Non-Food Bank Users|Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks among non-Ffood Bank Users|baseline and 4 weeks||||types/day||Standard Deviation|Mean
2552826|NCT02787564|Secondary|Amount of Fruits and Vegetables Among Food Bank Users|Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks among food bank users|baseline and 4 weeks||||portions/day||Standard Deviation|Mean
2552827|NCT02787564|Secondary|Variety of Fruits and Vegetables Among Food Bank Users|Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks among food bank users.|baseline and 4 weeks||||types/day||Standard Deviation|Mean
2552828|NCT02787564|Primary|Amount of Fruits and Vegetables|Change from Baseline in the Amount of Fruit and Vegetables Consumed per Day at 4 weeks|baseline and 4 weeks||||portions/day||Standard Deviation|Mean
2552829|NCT02787564|Primary|Variety of Fruits and Vegetables|Change from Baseline in the Types of Fruit and Vegetables Consumed per Day at 4 weeks|baseline and 4 weeks||||types/day||Standard Deviation|Mean
2552830|NCT02787551|Secondary|Number of Documented Symptomatic Hypoglycemia Events Per Participant-Year: Single Arm Extension Period|Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (70 mg/dL). Hypoglycemic episodes with plasma glucose of <3.0 mmol/L (54 mg/dL) were also analyzed.|From Baseline to Week 52|Analysis was performed on safety population who entered the extension period and their data for whole study duration was analyzed and reported.|||events per participant-year|||Number
2552832|NCT02787551|Secondary|Change From Baseline in Body Weight to Week 52: Single Arm Extension Period|Change in body weight was calculated by subtracting baseline value from Week 52 value.|Baseline, Week 52|"Analysis was performed using mITT population who entered the extension period. Here, overall number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment."|||kg||Standard Error|Mean
2552834|NCT02787551|Secondary|Percentage of Participants Requiring Rescue Therapy During the 52 Week Treatment Period: Single Arm Extension Period|Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c >8%.|From Week 26 to Week 52|Analysis was performed on mITT population who entered the extension period.|||percentage of participants|||Number
2552835|NCT02787551|Secondary|Percentage of Participants Requiring Rescue Therapy During the 26 Week Treatment Period: Core Period|Routine HbA1c value was used to determine the requirement of rescue medication. Threshold values at Week 12 or later on Week 12: HbA1c >8%.|From Baseline to Week 26|Analysis was performed using mITT population.|||percentage of participants|||Number
2552836|NCT02787551|Secondary|Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 52: Single Arm Extension Period|2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before IMP administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF.|Baseline, Week 52|"Analysis was performed on mITT population who entered the extension period. Here, overall number of participants analyzed = participants with baseline and Week 52 assessments."|||mmol/L||Standard Error|Mean
2552837|NCT02787551|Secondary|Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test to Week 26: Core Period|2-hour plasma glucose excursion = 2-hour PPG value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF.|Baseline, Week 26|"Analysis was performed using mITT population. Here, overall number of participants analyzed = participants with baseline and Week 26 assessments."|||mmol/L||Standard Error|Least Squares Mean
2552838|NCT02787551|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 52: Single Arm Extension Period|The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 52 value. Missing data was imputed using LOCF.|Baseline, Week 52|"Analysis was performed on mITT population who entered the extension period. Here, overall number of participants analyzed = participants with baseline and at least one post-baseline plasma glucose assessment."|||mmol/L||Standard Error|Mean
2552839|NCT02787551|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) During Standardized Meal Test to Week 26: Core Period|The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last observation carried forward (LOCF).|Baseline, Week 26|"Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with baseline and at least one post-baseline plasma glucose assessment."|||mmol/L||Standard Error|Least Squares Mean
2552840|NCT02787551|Secondary|Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 52: Single Arm Extension Period|The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal.|Baseline, Week 52|"Analysis was performed on mITT population who entered the extension period. Here, overall number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment."|||mmol/L||Standard Error|Mean
2552841|NCT02787551|Secondary|Change From Baseline in the Daily Average of the 7-point Self-monitored Plasma Glucose (SMPG) to Week 26: Core Period|The 7-point SMPG profile was measured at the following 7 points: pre-prandial and 2 hours postprandial for breakfast, lunch, dinner and at bedtime. Two hours postprandial (breakfast, lunch and dinner) was defined as 2 hours after the start of the meal. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period.|Baseline, Week 26|"Analysis was performed using mITT population. Here, overall number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment."|||mmol/L||Standard Error|Least Squares Mean
2552842|NCT02787551|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52: Single Arm Extension Period|Change in FPG was calculated by subtracting baseline value from Week 52 value.|Baseline, Week 52|"Analysis was performed on mITT population who entered the extension period. Here, overall number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment."|||mmol/L||Standard Error|Mean
2552843|NCT02787551|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) to Week 26: Core Period|Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted LS means and SE were obtained from MMRM to account for missing data using all available post baseline data during the 26 week treatment period.|Baseline, Week 26|"Analysis was performed using mITT population. Here, overall number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment."|||millimoles per litre (mmol/L)||Standard Error|Least Squares Mean
2552844|NCT02787551|Secondary|Percentage of Participants Reaching HbA1c <7 % or <=6.5% at Week 52: Single Arm Extension Period|Participants without any available HbA1c assessment at Week 52 were considered as non-responders.|Week 52|Analysis was performed on mITT population who entered the extension period.|||percentage of participants|||Number
2552845|NCT02787551|Secondary|Percentage of Participants Reaching HbA1c <7% or <=6.5% at Week 26: Core Period|Participants without any available HbA1c assessment at Week 26 were considered as non-responders.|Week 26|Analysis was performed on mITT population.|||percentage of participants|||Number
2552846|NCT02787551|Primary|Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 52: Single Arm Extension Period|Change in HbA1c was calculated by subtracting baseline value from Week 52 value.|Baseline, Week 52|Analysis was performed on mITT population who entered the extension period. Here, “Overall number of participants analyzed” = participants with baseline and at least 1 post-baseline HbA1c assessment.|||percentage of HbA1c||Standard Error|Mean
2552864|NCT02787057|Secondary|Secondary Treatment Failure Rate|Secondary treatment failure was defined as treatment failure despite adjustment of antibiotics or changing to second line antibiotics for 3 to 5 days in patients with primary treatment failure|after 6 to 8 days of treatment||||Participants|||Count of Participants
2552847|NCT02787551|Primary|Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period|Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least squares (LS) mean and standard error (SE) were obtained from Mixed-effect model with repeated measures (MMRM) to account for missing data using all available post baseline data during the 26 week treatment period.|Baseline, Week 26|Modified Intent-To-Treat (mITT) population:all randomized participants who had a baseline and at least 1 post-baseline assessment of any primary/secondary outcome measures, irrespective of compliance with study protocol and procedures.“Overall number of participants analyzed”=participants with baseline and at least 1 post-baseline HbA1c assessment.|||percentage of HbA1c||Standard Error|Least Squares Mean
2552848|NCT02787304|Secondary|Change From Baseline to Week 48 on Serum Lipids|Serum lipids level will be measured by calculating fasting total cholesterol, high-density lipoprotein-cholesterol (HDL-C), low-density lipoprotein-cholesterol (LDL-C), and triglycerides.|Baseline, Week 48|Safety Analysis Set (post hoc analysis) - for subjects with Week 48 data at the time of interim analysis|||mg/dL||Standard Deviation|Mean
2552849|NCT02787304|Secondary|Change From Baseline to Week 48 on Metabolic Indicators|Metabolic indicators will be assessed by measuring hemoglobin A1c (HbA1c).|Baseline, Week 48|Safety Analysis Set (post hoc analysis) - for subjects with Week 48 data at the time of interim analysis.|||percentage of glycated hemoglobin||Standard Deviation|Mean
2552850|NCT02787304|Secondary|Change From Baseline to Week 48 on Metabolic Indicators|Metabolic indicators will be assessed by measuring fasting serum glucose levels and insulin levels.|Baseline, Week 48|Safety Analysis Set (post hoc analysis) - for subjects with Week 48 data at the time of interim analysis. For insulin levels, samples were collected but due to study termination for futility after the interim analysis, an analysis of this outcome measure was not performed.|||mg/dL||Standard Deviation|Mean
2552851|NCT02787304|Secondary|Change From Baseline to Week 48 on Serum Liver-related Biochemistry|Serum liver-related biochemistry will be analysed by measuring total bilirubin (TB).|Baseline, Week 48|Safety Analysis Set (post hoc analysis) - for subjects with Week 48 data at the time of interim analysis|||mg/dL||Standard Deviation|Mean
2552852|NCT02787304|Secondary|Change From Baseline to Week 48 on Serum Liver-related Biochemistry|Serum liver-related biochemistry will be analysed by measuring alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and gamma glutamyl transferase (GGT).|Baseline, Week 48|Safety Analysis Set (post hoc analysis) - for subjects with Week 48 data at the time of interim analysis|||U/L||Standard Deviation|Mean
2552853|NCT02787304|Secondary|Number of Participants With Resolution of NASH at Week 48|Resolution of NASH is defined as total absence of ballooning [score = 0], absent or mild inflammation [score 0-1], steatosis can be present [score 0-3]) without worsening of fibrosis as assessed by liver histology at Week 48.|Week 48|Safety Analysis Set for subjects with liver biopsy at both Baseline and Week 48 (post hoc analysis) at the time of the interim analysis|||Participants|||Count of Participants
2552854|NCT02787304|Secondary|Change From Baseline to Week 48 on Liver Histology|Change in liver histology will be measured by fibrosis stage. Fibrosis stage is assessed on a scale of 0-4 with higher scores indicating more severe disease and lower scores indicating less severe disease (F0 = no fibrosis, F4 = cirrhosis).|Baseline, Week 48|Full Analysis Set for subjects with liver biopsy at both Baseline and Week 48 (post hoc analysis) at the time of the interim analysis|||units on a scale||Standard Deviation|Mean
2552855|NCT02787304|Secondary|Change From Baseline to Week 48 on Hepatic Steatosis|Change in hepatic steatosis will be evaluated by measuring the reduction of liver fat with magnetic resonance imaging-proton density fat-fraction (MRI-PDFF) and stratified by treatment group.|Baseline, Week 48|Safety Analysis Set (post hoc analysis) - for subjects with Week 48 data at the time of interim analysis|||absolute percentage||Standard Deviation|Mean
2552856|NCT02787304|Secondary|Change From Baseline to Week 48 on Liver Histology|Change in liver histology will be measured by the individual NAS components (ballooning, inflammation, steatosis). The NAS grades NAFLD on liver biopsy based on the individual scoring of steatosis, inflammation and ballooning. The NAS is assessed on a scale of 0 to 8 with higher scores indicating more severe disease and lower scores indicating less severe disease. NAS is obtained by adding steatosis (assessed on a scale of 0 to 3), inflammation (assessed on a scale of 0 to 3) and ballooning (assessed on a scale of 0 to 2).|Baseline, Week 48|Safety Analysis Set for subjects with liver biopsy at both Baseline and Week 48 (post hoc analysis) at the time of the interim analysis|||score on a scale||Standard Deviation|Mean
2552857|NCT02787304|Primary|Number of Subjects Achieving Binary Response on Liver Histology Between Volixibat (SHP626) and Placebo at Week 48|Binary response indicating (yes/no) whether a subject responded at week 48 with a reduction of at least 2 points, without worsening of fibrosis, from baseline nonalcoholic fatty liver disease (NAFLD) activity score (NAS). The NAS grades NAFLD on liver biopsy based on the individual scoring of steatosis, inflammation and ballooning. The NAS is assessed on a scale of 0 to 8 with higher scores indicating more severe disease and lower scores indicating less severe disease. NAS is obtained by adding steatosis(assessed on a scale of 0 to 3), inflammation (assessed on a scale of 0 to 3) and ballooning (assessed on a scale of 0 to 2).|Baseline, Week 48|Full Analysis Set for subjects with liver biopsy at both Baseline and Week 48 (post hoc analysis) at the time of the interim analysis|||Participants|||Count of Participants
2552858|NCT02787083|Secondary|Side Effects of Medication|Will assess if participants have side effects of medication via office visits|12 weeks|||||||
2552859|NCT02787083|Secondary|Sexual Function|Evaluate changes in sexual function via FSFI questionnaire|12 weeks|||||||
2552860|NCT02787083|Secondary|Patient Satisfaction|evaluate participant satisfaction with treatment/placebo via Global response assessment form|12 weeks|||||||
2552861|NCT02787083|Secondary|Impact on Quality of Life|Evaluate impact on quality of life from bladder, bowel and vaginal/pelvic symptoms via PFIQ-7 questionnaire|12 weeks|||||||
2552862|NCT02787083|Secondary|Number of Participants With Improvement in Incontinence Episodes|Evaluate incontinence episodes via bladder diary and UDI-6 questionnaire|12 weeks||||Participants|||Count of Participants
2552863|NCT02787083|Primary|Number of Participants With Interstitial Cystitis Symptom Improvement|Evaluate urinary urgency, frequency and pain via validated O'Leary Sant questionnaire|12 weeks||||Participants|||Count of Participants
2560611|NCT02662569|Secondary|Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2552865|NCT02787057|Secondary|Primary Treatment Failure Rate|Primary treatment failure was defined as the presence of fever, abdominal pain, and turbid peritoneal dialysate, and if the total peritoneal WBC counts is >50% of the pretreatment values after 3 days of treatment by the assigned antibiotics|after 3 days of treatment by the assigned antibiotics||||Participants|||Count of Participants
2552866|NCT02787057|Secondary|Primary Response Rate|Primary response was defined as resolution of peritonitis (normalization of body temperature, resolution of abdominal pain, clearing of dialysate, and PD effluent neutrophil count less than 100 cells/mL and proportion of polynuclear cell less than 50%) on day 10 by using antibiotics alone|on day 10 by using antibiotics alone||||Participants|||Count of Participants
2552867|NCT02787057|Primary|Complete Cure Rate|complete cure was defined as complete resolution of peritonitis (normalization of body temperature, resolution of abdominal pain, clearing of dialysate, and PD effluent neutrophil count less than 100 cells/mL and proportion of polynuclear cell less than 50%) by using antibiotics alone without relapse within 4 weeks of completion of therapy|within 4 weeks of completion of therapy||||Participants|||Count of Participants
2552868|NCT02786953|Secondary|Adherence (Self Care Inventory) Teen|The teen versions of the Self Care Inventory will be used to measure adherence to the diabetes treatment regimen. Mean scores are calculated, ranging from 1-5, with higher scores indicating better adherence.|Baseline and 3 months||||score on a scale||Standard Deviation|Mean
2552869|NCT02786953|Secondary|Adherence (Self Care Inventory) Parent|The parent versions of the Self Care Inventory will be used to measure adherence to the diabetes treatment regimen. Mean scores are calculated, ranging from 1-5, with higher scores indicating better adherence.|Baseline and 3 months||||score on a scale||Standard Deviation|Mean
2552870|NCT02786953|Secondary|Quality of Life (PedsQL)|The PedsQL, Type 1 Diabetes module, a self-report measure of quality of life will be used. Scaled scores range from 0-100, and higher scores indicate better quality of life.|Baseline and 3 months|only participants with both baseline and 3 month data|||score on a scale||Standard Deviation|Mean
2552871|NCT02786953|Primary|Sleep Duration: 3 Months|Sleep duration will be measured with actigraphy (total sleep time)|3 months|only participants with usable actigraph data|||hours||Standard Deviation|Mean
2552872|NCT02786953|Primary|Sleep Duration: Baseline|Sleep duration will be measured with actigraphy (total sleep time)|baseline|only participants with usable actigraph data|||hours||Standard Deviation|Mean
2552873|NCT02786953|Primary|Glycemic Control (HbA1c) 3 or 6 Months|HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits.|3 months or 6 months|Some participants missed the 3 month appointment, so the final result is a combination of 3 month and 6 month values|||percentage of glycosylated Hemoglobin||Standard Deviation|Mean
2552874|NCT02786953|Primary|Glycemic Control (HbA1c) Baseline|HbA1C is a measure of average blood glucose levels. It is measured quarterly at regular clinic visits.|Baseline||||percentage of glycosylated Hgb||Standard Deviation|Mean
2552875|NCT02786953|Primary|Sleep Quality 3 Months|Sleep quality will be measured with the Pittsburgh Sleep Quality Index total score. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.|3 months|includes only participants with baseline and 3 month data|||score on a scale||Standard Deviation|Mean
2552876|NCT02786953|Primary|Sleep Quality: Baseline|Sleep quality will be measured with the Pittsburgh Sleep Quality Index total score. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.|baseline||||score on a scale||Standard Deviation|Mean
2552877|NCT02786927|Secondary|Percentage of Participants Preferring the Inhaler Based on the Size of the Inhaler|Preference between ELLIPTA inhaler and HandiHaler based on the size of the inhaler was assessed by the inhaler preference questionnaire at Visit 3 or EW visit. The responses were analyzed using a Cochran-Mantel-Haenszel test, adjusted for study inhaler use sequence and preference questionnaire version.|Up to 18 days|Modified ITT Population|||Percentage of participants|||Number
2552878|NCT02786927|Secondary|Percentage of Participants Preferring the Inhaler Based on How Easy it Was to Tell How Many Doses Were Left|Preference between ELLIPTA inhaler and Handihaler based on how easy it was to tell how many doses were left was assessed by the inhaler preference questionnaire at Visit 3 or EW visit. The responses were analyzed using a Cochran-Mantel-Haenszel test, adjusted for study inhaler use sequence and preference questionnaire version.|Up to 18 days|Modified ITT Population|||Percentage of participants|||Number
2552879|NCT02786927|Primary|Percentage of Participants Preferring the Inhaler Based on the Number of Steps Needed to Take the COPD Medication|Preference between ELLIPTA inhaler and Handihaler based on the number of steps needed to take the medication was assessed by the inhaler preference questionnaire at Visit 3 or Early Withdrawal (EW) visit. The responses were analyzed using a Cochran-Mantel-Haenszel test, adjusted for study inhaler use sequence and preference questionnaire version. The analysis was performed on the Modified Intent-to-treat (ITT) Population comprised of all participants in the ITT Population (comprised all randomized participants who received 1 dose of at least 1 study inhaler) who completed at least one question from the 5 preference questions.|Up to 18 days|Modified ITT Population|||Percentage of participants|||Number
2552880|NCT02786901|Secondary|Number of Participants With Treatment Failure at Visit 5 (Postoperative Day 8)|A participant was considered a treatment failure at Visit 5 if they started any rescue medication prior to, or on the day of, Visit 5. If a subject did not have a Visit 5, due either to early discontinuation or to a missed visit, then treatment failure at Visit 5 was defined as starting rescue medication prior to, or on, Postoperative Day 8.|8 days||||Participants|||Count of Participants
2552907|NCT02785900|Secondary|Event-free Survival|Event-free survival is calculated from the time of randomization to the first documentation of progression, relapse, or death, whichever comes first. Patients who do not have event (progression, relapse, or death) prior to analysis cutoff date are censored at the date of last response assessment. Patients who started another anticancer therapy before progression, relapse, or death are censored at the date of last response assessment prior to the start of new therapy. Patients who do not have response assessment post-baseline are censored at the date of randomization.|Up to approximately 11.24 months|Intent-to-treat analysis set|||months||95% Confidence Interval|Median
2552881|NCT02786901|Secondary|Change From Baseline in Summed Anterior Chamber (AC) Cell and Flare Scores at Final On-Treatment Visit|Slit lamp examination was performed. White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on a 5-point scale: 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Very Severe). The combined endpoint was defined as the sum of the scores for AC cells and AC flare. Summed Anterior Chamber (AC) Cell and Flare Scores could range from 0 to 8.|14 days|Missing values and post-rescue values imputed using last observation carried forward.|||score on a scale||Standard Deviation|Mean
2552882|NCT02786901|Secondary|Number of Participants With Complete Resolution of Both Anterior Chamber (AC) Cells and AC Flare in the Study Eye at Final On-Treatment Visit|Slit lamp examination was performed. White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Complete resolution of AC cells was defined as Cell score = 0 in the study eye. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on a 5-point scale: 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Very Severe). An AC flare score of 0 in the study eye was considered complete resolution.|14 days|Missing values and post rescue values imputed as failures.|||Participants|||Count of Participants
2552883|NCT02786901|Secondary|Number of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye at Final On-Treatment Visit|Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on a 5-point scale: 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Very Severe). An AC flare score of 0 in the study eye was considered complete resolution.|14 days|Missing values and post rescue values imputed as failures.|||Participants|||Count of Participants
2552884|NCT02786901|Secondary|Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Final On-Treatment Visit|Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on a 6-point scale: 0 (None), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Moderately Severe), and 5 (Severe). Complete Resolution of Ocular Pain was defined as Pain Score = 0.|14 days|Missing values and post rescue values imputed as failures.|||Participants|||Count of Participants
2552885|NCT02786901|Secondary|Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells in the Study Eye at Final On-treatment Visit.|Slit lamp examination was performed. White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Complete resolution of AC cells was defined as Cell score = 0 in the study eye.|14 days|Missing values and post rescue values imputed as failures.|||Participants|||Count of Participants
2552886|NCT02786901|Primary|Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Visit 5 (Postoperative Day 8)|Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on a 6-point scale: 0 (None), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Moderately Severe), and 5 (Severe). Complete Resolution of Ocular Pain was defined as Pain Score = 0.|8 days|Missing values and post rescue values imputed as failures.|||Participants|||Count of Participants
2552887|NCT02786901|Primary|Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells at Visit 5 (Postoperative Day 8)|Slit lamp examination was performed. White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Complete resolution of AC cells was defined as Cell score = 0 in the study eye.|8 days|Missing values and post rescue values imputed as failures.|||Participants|||Count of Participants
2552888|NCT02786810|Secondary|Number of Participants With Adverse Events Related to the Study Drug.|The study will evaluate how many people experience adverse events, specifically the two most common effects (headache and nausea), during the study or during the week following the study.|1 week||||participants|||Number
2552889|NCT02786810|Primary|Visualization of Renal Scars Compared to Previous Imaging|The study will evaluate the contrast agent's ability to enable the ultrasound to produce adequate images of the kidneys as compared to the subject's previous renal imaging. This outcome will be measured in percentage of scars visualized by other imaging methods that were detected by using the contrast agent.|1 hour|In addition to the 7 patients analyzed, 3 participants were excluded from this analysis because they did not have previous scars to analyze.|||Percentage of previous scars visualized|||Number
2552890|NCT02786771|Primary|Difference in Perceived Stress and Stress Resilience From Enrollment to Closeout|"The change of perceived stress and stress resilience within and between Group 1 and 2 from enrollment to closeout.~The change of perceived stress is measured by the Perceived Stress Scale-14 (a validated psychological instrument of 14 items), each each rated on a 5 point scale(0-4) for measuring the respondent's perception of stress in the past month.The PSS-14 ranges from 0 to a high score of 56, with a higher score indicating more stress (worse outcome).~The change of stress resilience is measured by the Connor-Davidson Stress Resilience Scale (25 items). It evaluates different aspects of stress coping ability that seeks to understand how well respondents would be able to buffer adverse conditions and cope with stress, each rated on a 5 point scale (0-4). The CD-RISC ranges from 0 to 100, with a higher score representing better stress resilience (a better outcome)."|total of 8 weeks (2 weeks of baseline + 6 weeks of intervention)|Adults over 18 who responded to a online advertisement|||units on a scale||Standard Deviation|Mean
2552908|NCT02785900|Secondary|Duration of Remission|Duration of remission is calculated from the first documentation of CR or CRi to the first documentation of disease relapse or death, whichever comes first. Patients who are in remission at the time of analysis cutoff are censored at the date of last response assessment. Patients who started another anticancer therapy before relapse or death are censored at the date of last response assessment prior to start of new therapy.|Up to approximately 9.5 months|Patients who achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi).|||months||Full Range|Median
2552891|NCT02786719|Secondary|the Response Rate Following Induction Chemotherapy Without Prophylactic Granulocyte Colony Stimulating Factor (G-CSF)|"Response rate in the participants that completed all 6 cycles of induction chemotherapy on study. Response rate as categorize by International neuroblastoma response criteria.~Complete response (CR): No evidence of primary tumor; no evidence of metastases (chest, abdomen, liver, bone, bone marrow, nodes, etc.), and urine catecholamines homovanillic acid (HVA)/ vanillylmandelic acid (VMA) normal. MIBG scan must be negative to qualify for CR.~Very good partial response (VGPR): Greater than 90% reduction in primary tumor; no metastatic tumor (as above except bone); no new bone lesions, all pre-existing lesions improved, HVA/VMA normal~Partial Response (PR): 50-90% reduction of primary tumor; 50% or greater reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by 50%"|through study completion, approximately 5 months|Completed all 6 cycles of induction chemotherapy on study|||Participants|||Count of Participants
2552892|NCT02786719|Secondary|Delay in Chemotherapy Administration Due to Prolonged Neutrophil Recovery|incidence of delay in chemotherapy administration due to prolonged neutrophil recovery|through study completion, approximately 5 months|58 cycles of chemotherapy administered to 12 participants|||chemotherapy cycles|Chemotherapy cycles||Number
2552893|NCT02786719|Primary|Incidence of Infection|Incidence of infections in chemotherapy cycles NOT followed by hematopoietic growth factors|through study completion, approximately 5 months|Includes all patients evaluable for endpoint|||infections|||Number
2552894|NCT02786355|Primary|Tidal Volume (ml)|volume of air delivered via Frova bougie (milliliters)|15 minutes||||tidal volume (ml)||Standard Deviation|Mean
2552895|NCT02786004|Secondary|Number of Subjects Experiencing a Device Related Adverse Events, Serious Adverse Event, Unanticipated Device Effect, and Device Defects by Overall Occurrence.|Safety-related endpoint data (adverse events, serious adverse event, unanticipated device effect, and device defects) were monitored from all subjects for the duration of their participation. Results were summarized by cohort.|Through study completion, approximately 3 months|Twenty-four subjects were enrolled into the study, of which 14 were enrolled into the FFDM cohort and 10 into the DBT cohort. One (1) subject was withdrawn from the DBT cohort but was followed for AE, SAE, and UADE for the duration of her participation.|||participants|||Number
2552896|NCT02786004|Primary|Number of Participants With Acceptable Overall Clinical Image Quality|"Overall clinical image quality was assessed by Mammography Quality Standards Act (MQSA) qualified radiologists (readers). Readers documented acceptability of FFDM and DBT image quality and image characteristics, as set for in the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System (2012)."|At enrollment completion approximately 3 months post initiation||||Participants|||Count of Participants
2552897|NCT02785913|Secondary|Frequency and Severity of Toxicities Associated With GDC-0032. (Phase II)|Frequency and severity of toxicities greater than Grade 2 associated with GDC-0032.|From date of registration to maximum of 3 years.|Number of Subjects with Greater than Grade 2 Toxicity.|||participants|||Number
2552898|NCT02785913|Secondary|Duration of Response (DoR) Both in the Entire S1400B PI3K FMI Positive Study Population and in GNE Positive Patients Treated With GDC-0032 Who Achieve a CR or PR (Confirmed and Unconfirmed) by RECIST 1.1.|Among patients who had a response, duration is calculated from registration to response date.|From time of registration to maximum of 3 years.|This study only had one responder.|||months|||Number
2552899|NCT02785913|Secondary|ORR in the Entire S1400B (PI3K FMI Positive) Study Population Treated With GDC-0032.|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).|From time of registration to maximum of 3 years.||||Participants|||Count of Participants
2552900|NCT02785913|Secondary|Investigator-assessed Progression Free Survival (IA-PFS) and Overall Survival (OS) in Both the Subset of Patients Defined to be PI3K GNE-positive and in the Entire S1400B (PI3K FMI Positive) Study Population Treated With GDC-0032.||From time of registration to maximum of 3 years.||2020-06-30|06/2020||||
2552901|NCT02785913|Primary|Objective Response Rate (ORR) for PI3K GNE-positive Patients Registered to S1400B Treated With GDC-0032.|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).|From date of registration to maximum of 3 years.|PI3K GNE-positive patients only.|||Participants|||Count of Participants
2552902|NCT02785900|Secondary|Mortality Rates at Day 30 and Day 60|30- and 60-day survival from date of randomization. Estimated using Kaplan-Meier method.|Up to 60 days|Intent-to-Treat Analysis Set|||percentage of participants||95% Confidence Interval|Number
2552903|NCT02785900|Secondary|Time to Complete Remission|Time to CR or CRi is the time from randomization to the first documentation of CR/CRi|Up to 1.5 years|Intent-to-Treat Analysis Set - Patients who Achieved CR/CRi.|||weeks||Full Range|Median
2552904|NCT02785900|Secondary|Incidence of Grade 3 or Higher Laboratory Abnormalities|Participants who experienced a laboratory grade increase to Grade 3 or higher (per National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI CTCAE], v4.03)|Up to 1.5 years|Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.|||Participants|||Count of Participants
2552905|NCT02785900|Secondary|Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events|"Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. SAE = serious adverse event. Study treatment in this data set refers to blinded study treatment."|Up to 1.5 years|Safety analysis set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.|||Participants|||Count of Participants
2552906|NCT02785900|Secondary|Leukemia-free Survival|Leukemia-free survival is calculated from the first documentation of blast clearance (CR, CRi, mLFS) to the first documentation of disease relapse or death, whichever comes first. Patients who are in remission at the time of analysis cutoff are censored at the date of last response assessment. Patients who started another anticancer therapy before relapse or death are censored at the date of last response assessment prior to start of new therapy.|Up to approximately 9.49 months|Patients who achieved CR/CRi|||months||Full Range|Median
2560612|NCT02662569|Secondary|Percent Change From Baseline in Apolipoprotein B100 at Week 12||Baseline and week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2552910|NCT02785900|Primary|Composite Complete Remission (CRc) Rate|Number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) according to the modified response criteria for acute myeloid leukemia (AML) per Cheson 2003.|Up to 1.5 years|Intent-to-treat analysis set|||participants||95% Confidence Interval|Number
2552911|NCT02785900|Primary|Overall Survival|Time from randomization to death due to any cause|Up to 1.5 years|Intent-to-treat analysis set|||months||Inter-Quartile Range|Median
2552912|NCT02785770|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUClast) of PF-04447943|Area under the plasma concentration-time from time zero to time of last measurable concentration. Observed using the linear/log trapezoidal method.|Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose|PK parameter analysis population included all enrolled participants treated with PF-04447943 and who had at least 1 of the PK parameters of interest.|||Nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2552913|NCT02785770|Secondary|Time of Observed Maximum Plasma Concentration (Tmax) of PF-04447943||Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose|PK parameter analysis population included all enrolled participants treated with PF-04447943 and who had at least 1 of the PK parameters of interest.|||Hours||Full Range|Median
2552914|NCT02785770|Secondary|Maximum Plasma Concentration (Cmax) of PF-04447943||Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose|Pharmacokinetic (PK) parameter analysis population included all enrolled participants treated with PF-04447943 and who had at least 1 of the PK parameters of interest.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2552915|NCT02785770|Secondary|Number of Participants With Laboratory Test Abnormalities|Hemoglobin(Hgb), hematocrit, red blood cell(RBC)<0.8*lower limit of normal(LLN), mean corpuscular(MC) Hgb, MC volume <0.9*LLN, >1.1*upper limit of normal(ULN), platelet<0.5*LLN,>1.75*ULN, lymphocyte, neutrophil<0.8*LLN, >1.2*ULN, basophil, eosinophil, monocyte>1.2*ULN, white blood cell(WBC)<0.6*LLN,>1.5*ULN, reticulocytes<0.5*LLN,>1.5*ULN; bilirubin>1.5*ULN, aspartate aminotransferase(AT), alanine AT, alkaline phosphatase>3.0*ULN, protein, albumin<0.8*LLN,>1.2*ULN; blood urea nitrogen, creatinine>1.3*ULN, uric acid>1.2*ULN; sodium<0.95*LLN,>1.05*ULN, potassium, chloride, calcium, bicarbonate<0.9*LLN,>1.1*ULN; glucose<0.6*LLN, >1.5*ULN, HbA1c>1.3*ULN, creatinine kinase>2*ULN; urine-specific gravity<1.003,>1.030, pH<4.5,>8, WBC, RBC>=20, bacteria>20, urobilinogen, glucose, ketone, protein, Hgb, nitrite, leukocyte esterase, bilirubin>=1; thyroid stimulating hormone<0.8*LLN,>1.2*ULN; cholesterol, triglycerides>1.3*ULN, high density lipoprotein cholesterol(DL-C) <0.8*LLN, low DL-C>1.2*ULN.|Baseline (Pre-dose) up to 24 hours post-dose|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2552916|NCT02785770|Secondary|Number of Participants With Vital Sign Abnormalities|Criteria for vital sign abnormalities: supine and standing pulse rate <40 bpm or greater than (>) 120 bpm, supine and standing systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine and standing diastolic blood pressure (DBP) <50 mmHg, maximum (max.) increase from baseline (IFB) and decrease from baseline (DFB) in supine and standing SBP of >=30 mmHg, maximum IFB and DFB in supine and Standing DBP of >=20 mmHg.|Baseline (Pre-dose) up to 24 hours post-dose|Safety analysis set included all participants who received at least one dose of study medication.|||Participants|||Count of Participants
2552917|NCT02785770|Secondary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for ECG abnormalities: maximum QTc corrected for heart rate using Bazett's formula (QTcB) and QTcF interval (450 to less than [<] 480 msec, 480 to <500 msec, greater than or equal to [>=] 500 msec; increase from baseline [IFB] >=30 msec and <60 msec, IFB >=60 msec). Baseline was defined as the average of the means obtained from the 3 sets of triplicate measurements taken at -1, -0.5 and 0 hours pre-dose on Day 1 within each intervention period.|Baseline up to 24 hours post-dose|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2552918|NCT02785770|Secondary|Number of Participants With Physical Examination Abnormalities|Full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Physical examination abnormalities were judged by the investigator.|Baseline (Pre-dose)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2552919|NCT02785770|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state.|Baseline (Pre-dose) up to 28 days after last dose of study drug (56 days)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2552920|NCT02785770|Secondary|Time-Matched Mean Difference in QRS Interval for PF-04447943 and Placebo|Least square mean of QRS interval measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.|0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose|ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period. The outcome measure was planned not to be analyzed for reporting group: Moxifloxacin 400 mg.|||Msec||Standard Error|Least Squares Mean
2552921|NCT02785770|Secondary|Time-Matched Mean Difference in PR Interval for PF-04447943 and Placebo|Least square mean of PR interval measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.|0.5, 1, 2, 3, 4, 8, 12 and 24 hours post-dose|ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period. This outcome measure was planned not to be analyzed for reporting group: Moxifloxacin 400 mg.|||Msec||Standard Error|Least Squares Mean
2560613|NCT02662569|Secondary|Percent Change From Baseline in Apolipoprotein B100 at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2552922|NCT02785770|Secondary|Time-Matched Mean Difference in Heart Rate for PF-04447943 and Placebo|Least square mean of heart rate measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.|0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose|ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period. This outcome measure was planned not to be analyzed for reporting group: Moxifloxacin 400 mg.|||Beats per minute (bpm)||Standard Error|Least Squares Mean
2552923|NCT02785770|Primary|Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 24 Hours Post-Dose|Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.|24 hours post-dose|ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.|||Msec||Standard Error|Least Squares Mean
2552924|NCT02785770|Primary|Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 12 Hours Post-Dose|Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.|12 hours post-dose|ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.|||Msec||Standard Error|Least Squares Mean
2552925|NCT02785770|Primary|Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 8 Hours Post-Dose|Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.|8 hours post-dose|ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.|||Msec||Standard Error|Least Squares Mean
2552926|NCT02785770|Primary|Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 4 Hours Post-Dose|Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.|4 hours post-dose|ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.|||Msec||Standard Error|Least Squares Mean
2552927|NCT02785770|Primary|Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 3 Hours Post-Dose|Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.|3 hours post-dose|ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.|||Msec||Standard Error|Least Squares Mean
2552928|NCT02785770|Primary|Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 2 Hours Post-Dose|Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.|2 hours post-dose|ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.|||Msec||Standard Error|Least Squares Mean
2552929|NCT02785770|Primary|Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 1 Hour Post-Dose|Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.|1 hour post-dose|ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.|||Msec||Standard Error|Least Squares Mean
2552930|NCT02785770|Primary|Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 0.5 Hour Post-Dose|Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across PF-04447943 25 mg and placebo; PF-04447943 100 mg and placebo is reported in statistical analysis.|0.5 hour post-dose|Electrocardiogram (ECG) analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.|||Millisecond (Msec)||Standard Error|Least Squares Mean
2552931|NCT02785770|Secondary|Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for Moxifloxacin and Placebo|Least square mean of QTcF measure for each reporting arm has been reported in summary or descriptive statistics. Least square mean difference across Moxifloxacin and placebo is reported in statistical analysis.|0.5, 1 , 2, 3, 4, 8, 12 and 24 hours post-dose|ECG analysis population included all participants randomized and treated who had at least 1 post-dose ECG measurement in at least 1 period.|||Msec||Standard Error|Least Squares Mean
2552932|NCT02785588|Secondary|Subject Change in Temperature||1 Day|There were 54 enrolled subjects, with 2 withdrawn, resulting in 52 completed subjects for Phases 1 and 2 together. Additionally, the data from these 2 withdrawn subjects were not included in any statistical analysis.|||Degrees Celsius||Standard Deviation|Mean
2552933|NCT02785588|Secondary|Technical Issues and Malfunctions|Number and type of technical issues and device malfunctions|1 Day|There were 54 enrolled subjects, with 2 withdrawn, resulting in 52 completed subjects for Phases 1 and 2 together. Additionally, the data from these 2 withdrawn subjects were not included in any statistical analysis.|||number of occurrences|||Number
2552934|NCT02785588|Secondary|Bi-polar Product Description Scale|A measure of bi-polar items (opposite items), rated on a scale from 1 to 7. Closer to 1 indicates a measure closer to the first item and closer to 7 indicates a measure closer to the second item.|1 Day|There were 54 enrolled subjects, with 2 withdrawn, resulting in 52 completed subjects for Phases 1 and 2 together. Additionally, the data from these 2 withdrawn subjects were not included in any statistical analysis.|||score on a scale||Standard Deviation|Mean
2552935|NCT02785588|Secondary|Overall Experience With the Neonatal MR Scanner Device Summary|"User survey results on a scale from 1 to 5, where 1 = strongly disagree and 5 = strongly agree.~Question 1. I think that I would like to use this system frequently Question 2. I found the system unnecessarily complex Question 3. I thought the system was easy to use Question 4. I think that I would need support from a technician to be able to use this system Question 5. I found the various functions in this system were well integrated Question 6. I thought there was too much inconsistency in this system Question 7. I think that most people would learn to use this system very quickly Question 8. I found the system very cumbersome to use Question 9. I felt very confident using the system Question 10. I needed to learn a lot of things before I could get going with this system Question 11. I feel confident this system will meet my patient's needs Question 12. How likely is it that you would recommend this system to other professionals in your field?"|1 Day|There were 54 enrolled subjects, with 2 withdrawn, resulting in 52 completed subjects for Phases 1 and 2 together. Additionally, the data from these 2 withdrawn subjects were not included in any statistical analysis.|||score on a scale||Standard Deviation|Mean
2552936|NCT02785588|Secondary|Per Subject Workflow and Transport Information|Summary of means and standard deviations.|1 Day|There were 54 enrolled subjects, with 2 withdrawn, resulting in 52 completed subjects for Phases 1 and 2 together. Additionally, the data from these 2 withdrawn subjects were not included in any statistical analysis.|||minutes||Standard Deviation|Mean
2552937|NCT02785588|Secondary|Summary of Image Quality and Assessments for Phase 2|Scores range from 1-Very Poor image quality to 5-Excellent image quality.|1 Day||||score on a scale||Standard Deviation|Mean
2552938|NCT02785588|Secondary|Summary of Image Quality and Assessment for Phase 1|Scores range from 1-Very Poor image quality to 5-Excellent image quality.|1 Day||||score on a scale||Standard Deviation|Mean
2552939|NCT02785588|Primary|Number of Participants Who Experienced an Adverse Event in Phase 2|Safety will be assessed based on the number of Adverse Events in Phase 2.|1 Day||||Participants|||Count of Participants
2552940|NCT02785588|Primary|Image Diagnostic Quality for Phase 2|Number of subject whose images were rated as Evaluable.|1 Day||||Participants|||Count of Participants
2552941|NCT02785588|Primary|Number of Participants Who Experienced an Adverse Event in Phase 1|Safety will be assessed based on the number of Adverse Events in Phase 1.|1 Day||||Participants|||Count of Participants
2552942|NCT02785588|Primary|Image Diagnostic Quality for Phase 1|Number of subject whose images were rated as Evaluable.|1 Day||||Participants|||Count of Participants
2552943|NCT02785406|Secondary|Percent Medication Compliance as Assessed by Text Reminders and Replies|"Text-based reminders to take the medication will be enabled via using a HIPAA secure texting service (Talksoft ©), used broadly in medical settings. Participants will be prompted each night at 10 PM to take their medication, and instructed to text back yes when they have taken their medication."|day 2, day 4, day 7, day 9, day 11, and day 14||||percent medication compliance||Standard Deviation|Mean
2552944|NCT02785406|Secondary|Percent Medication Compliance as Assessed by Analysis of Riboflavin Markers in Urine Samples||day 2, day 4, day 7, day 9, day 11, and day 14||||percent medication compliance||Standard Deviation|Mean
2552945|NCT02785406|Secondary|Percent Medication Compliance as Assessed by Pill Counts||day 2, day 4, day 7, day 9, day 11, and day 14||||percent medication compliance||Standard Deviation|Mean
2552946|NCT02785406|Secondary|Percent Medication Compliance as Assessed by the Medical Event Monitoring System (MEMS, Aprex Corporation) Bottles||day 2, day 4, day 7, day 9, day 11, and day 14||||percent medication compliance||Standard Deviation|Mean
2552947|NCT02785406|Secondary|Stress as Assessed by a Visual Analog Scale (VAS) for Stress|Score provided is the total score (0 to 300) across three items that are each on a 0-100 scale. A higher score indicates greater stress.|day 0, day 2, day 4, day 7, day 9, day 11, and day 14||||units on a scale||Standard Deviation|Mean
2552948|NCT02785406|Secondary|Stress/Anxiety as Assessed by Cortisol Level During the Cold Pressor Test (CPT)|Cold Pressor Test (CPT) reliably increases activity of the sympathetic nervous system and the HPA axis, and produces reliable increases in heart rate and cortisol. Subjects are requested to submerge the dominant arm up to the wrist or elbow in ice-cold water (0° to 4° C) for as long as possible with a maximum of 90 seconds. The procedure activates afferent nerves and elicits a CNS stress response. This procedure produces no lasting biological or psychological distress beyond the acute challenge period, and physiological effects return to baseline within 90 min. In fact, the CPT is used to study pain in children, and is considered a noninvasive, exempt educational experimental activity by the IRB of the University of Texas-Austin. It has been used extensively in cardiology, endocrinology, psychiatry, and psychology since 1940 as a challenge to the peripheral and central stress axis.|day 0, day 7, and day 14|Where number analyzed is less than 10, data were not collected for the number that are not reported.|||pg/mL||Standard Deviation|Mean
2552949|NCT02785406|Secondary|Stress/Anxiety as Assessed by Blood Pressure During the Cold Pressor Test (CPT) - Diastolic Blood Pressure|Cold Pressor Test (CPT) reliably increases activity of the sympathetic nervous system and the HPA axis, and produces reliable increases in heart rate and cortisol. Subjects are requested to submerge the dominant arm up to the wrist or elbow in ice-cold water (0° to 4° C) for as long as possible with a maximum of 90 seconds. The procedure activates afferent nerves and elicits a CNS stress response. This procedure produces no lasting biological or psychological distress beyond the acute challenge period, and physiological effects return to baseline within 90 min. In fact, the CPT is used to study pain in children, and is considered a noninvasive, exempt educational experimental activity by the IRB of the University of Texas-Austin. It has been used extensively in cardiology, endocrinology, psychiatry, and psychology since 1940 as a challenge to the peripheral and central stress axis.|day 0, day 7, and day 14||||millimeters of mercury (mmHg)||Standard Deviation|Mean
2552963|NCT02785406|Primary|Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale|DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome.|day 7||||score on a scale||Standard Deviation|Mean
2553094|NCT02783170|Secondary|Number of Participants With Adverse Infant Outcomes Based on Medical Record Review|Number of participants with adverse infant outcomes. Missing data is data not collected or unavailable.|approximately 2 months|Safety Population - subjects randomized and received study intervention|||Participants|||Count of Participants
2552950|NCT02785406|Secondary|Stress/Anxiety as Assessed by Blood Pressure During the Cold Pressor Test (CPT) - Systolic Blood Pressure|Cold Pressor Test (CPT) reliably increases activity of the sympathetic nervous system and the HPA axis, and produces reliable increases in heart rate and cortisol. Subjects are requested to submerge the dominant arm up to the wrist or elbow in ice-cold water (0° to 4° C) for as long as possible with a maximum of 90 seconds. The procedure activates afferent nerves and elicits a CNS stress response. This procedure produces no lasting biological or psychological distress beyond the acute challenge period, and physiological effects return to baseline within 90 min. In fact, the CPT is used to study pain in children, and is considered a noninvasive, exempt educational experimental activity by the IRB of the University of Texas-Austin. It has been used extensively in cardiology, endocrinology, psychiatry, and psychology since 1940 as a challenge to the peripheral and central stress axis|day 0, day 7, and day 14||||millimeters of mercury (mmHg)||Standard Deviation|Mean
2552951|NCT02785406|Secondary|Sleep Quality as by the Pittsburg Sleep Quality Index (PSQI)|The Pittsburg Sleep Quality Index (PSQI) is an 18-item self-report measure of sleep, providing a well-validated and reliable measure of sleep quality, latency, duration, duration efficiency, and disturbance, and an overall summary. The overall summary score will be reported for this measure. The PSQI has been used in several studies of individuals with SUD, including cocaine. Total score ranges from 0-21, with a higher score indicating worse outcome.|day 0, day 2, day 4, day 7, day 9, day 11, and day 14|Data were not collected for days 2, 4, 9, and 11. For days 0, 7, and 14, where number analyzed is less than 10, data were not collected for the number that are not reported.|||score on a scale||Standard Deviation|Mean
2552952|NCT02785406|Secondary|Cue Reactivity as Assessed by the Cocaine Craving Questionnaire (CCQ) Brief|The Cocaine Craving Questionnaire (CCQ) Brief is a self-report, 14-item measure with five conceptual domains: Desire to Use, Intention to Use, Anticipation of Positive Outcome, Anticipation of Relief from Dysphoria, and Lack of Control over use. The measure is well validated and has been used in multiple studies of CUD. Total score ranges from 1 to 7. A higher score indicates a worse outcome.|day 0, day 7, and day 14||||score on a scale||Standard Deviation|Mean
2552953|NCT02785406|Primary|Anxiety as Assessed by the DASS21 Self-report Questionnaire|DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome.|day 14||||score on a scale||Standard Deviation|Mean
2552954|NCT02785406|Primary|Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale|DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome.|day 11||||score on a scale||Standard Deviation|Mean
2552955|NCT02785406|Primary|Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale|DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome.|day 9||||score on a scale||Standard Deviation|Mean
2552956|NCT02785406|Primary|Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale|DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome.|day 7||||score on a scale||Standard Deviation|Mean
2552957|NCT02785406|Primary|Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale|DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome.|day 4||||score on a scale||Standard Deviation|Mean
2552958|NCT02785406|Primary|Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale|DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome.|day 2||||score on a scale||Standard Deviation|Mean
2552959|NCT02785406|Primary|Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale.|DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome.|day 0||||score on a scale||Standard Deviation|Mean
2552960|NCT02785406|Primary|Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale|DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome.|day 14||||score on a scale||Standard Deviation|Mean
2552961|NCT02785406|Primary|Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale|DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome.|day 11||||score on a scale||Standard Deviation|Mean
2552962|NCT02785406|Primary|Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale|DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome.|day 9||||score on a scale||Standard Deviation|Mean
2552964|NCT02785406|Primary|Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale|DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome.|day 4||||score on a scale||Standard Deviation|Mean
2552965|NCT02785406|Primary|Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale|DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome.|day 2||||score on a scale||Standard Deviation|Mean
2552966|NCT02785406|Primary|Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale|DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome.|day 0||||score on a scale||Standard Deviation|Mean
2552967|NCT02785406|Primary|Total Sleep as Assessed by the Misfit Shine Device|Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth.|day 14|Data were not collected for 3 in the suvorexant arm and 5 in the placebo arm.|||hours||Standard Deviation|Mean
2552968|NCT02785406|Primary|Total Sleep as Assessed by the Misfit Shine Device|Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth.|day 11|Data were not collected for 4 in the suvorexant arm and 4 in the placebo arm.|||hours||Standard Deviation|Mean
2552969|NCT02785406|Primary|Total Sleep as Assessed by the Misfit Shine Device|Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth.|day 9|Data were not collected for 2 in the suvorexant arm and 4 in the placebo arm.|||hours||Standard Deviation|Mean
2552970|NCT02785406|Primary|Total Sleep as Assessed by the Misfit Shine Device|Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth.|day 7|Data were not collected for one in the suvorexant arm and 4 in the placebo arm.|||hours||Standard Deviation|Mean
2552971|NCT02785406|Primary|Total Sleep as Assessed by the Misfit Shine Device|Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth.|day 4|Data were not collected for 4 in the suvorexant arm and 4 in the placebo arm.|||hours||Standard Deviation|Mean
2552972|NCT02785406|Primary|Total Sleep as Assessed by the Misfit Shine Device|Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth.|day 2|Data were not collected for 2 in the suvorexant arm and 4 in the placebo arm.|||hours||Standard Deviation|Mean
2552973|NCT02785406|Primary|Total Sleep as Assessed by the Misfit Shine Device|Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth.|day 0|Data were not collected for one in the suvorexant arm and 5 in the placebo arm.|||hours||Standard Deviation|Mean
2552974|NCT02785406|Primary|Cue Reactivity as Assessed by the Attention Bias (AB) Task|The attention bias (AB) task is a saccade-based eye-tracking measurement, developed by the PI to assess attentional bias to drug cues. AB measures utilizing eye movements have produced moderate to robust effects for a broad class abused substances, including cocaine. The score ranges from 0 to 1. Higher scores indicate a worse outcome.|day 14|Data were not collected for one in the placebo arm.|||score on a scale||Standard Deviation|Mean
2552975|NCT02785406|Primary|Cue Reactivity as Assessed by the Attention Bias (AB) Task|The attention bias (AB) task is a saccade-based eye-tracking measurement, developed by the PI to assess attentional bias to drug cues. AB measures utilizing eye movements have produced moderate to robust effects for a broad class abused substances, including cocaine. The score ranges from 0 to 1. Higher scores indicate a worse outcome.|day 7|Data were not collected for one in the suvorexant arm and one in the placebo arm.|||score on a scale||Standard Deviation|Mean
2552976|NCT02785406|Primary|Cue Reactivity as Assessed by the Attention Bias (AB) Task|The attention bias (AB) task is a saccade-based eye-tracking measurement, developed by the PI to assess attentional bias to drug cues. AB measures utilizing eye movements have produced moderate to robust effects for a broad class abused substances, including cocaine. The score ranges from 0 to 1. Higher scores indicate a worse outcome.|day 0|Data were not collected for 1 in the placebo arm.|||score on a scale||Standard Deviation|Mean
2552977|NCT02785354|Primary|Composite Criterion (Clinically Relevant Bleeding, Arterial Thrombotic Events, Acute Coronary Syndrome, Death)|First event among clinically relevant bleeding, arterial thrombotic event, acute coronary syndrome, or death defined above.|One year|Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05).|||participants with events|||Number
2552978|NCT02785354|Primary|Death (All-cause)|All-cause death (cause of death not available in the database).|1 year|Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05).|||participants with events|||Number
2552979|NCT02785354|Primary|Acute Coronary Syndrome|"First hospitalization with primary diagnosis (ICD-10 codes) of:~Myocardial infarction (ST-segment elevation Myocardial infarction (STEMI) and non-ST-segment elevation Myocardial infarction(NSTEMI)),~Unstable angina."|One year|Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05).|||participants with events|||Number
2552980|NCT02785354|Primary|Arterial Thrombotic Event|"First hospitalization with primary diagnosis (ICD-10 codes) of:~Ischemic or undefined stroke,~Systemic arterial embolism."|1 year|Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05).|||participants with events|||Number
2552981|NCT02785354|Primary|Major Bleeding|"First hospitalization with primary diagnosis (ICD-10 codes) of:~Hemorrhagic stroke,~Other critical organ or site bleeding,~Other bleeding with transfusion, or acute post-hemorrhagic anemia or death during hospital stay."|1 year|Patients with a first dispensing of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks), gender, age at index date (± 1 year) and high-dimensional propensity score (hdPS, ± 0.05).|||participants with events|||Number
2552982|NCT02785354|Primary|Clinically Relevant Bleeding|"First hospitalization with primary diagnosis (Tenth Revision codes of the International Classification of Diseases (ICD-10 codes)) of:~Hemorrhagic stroke,~Other critical organ or site bleeding,~Other bleeding (gastro-intestinal bleeding, urogenital bleeding and other bleeding subtype)."|One year|Patients (pts) with a first dispensing (dispen.) of DOAC or VKA in 2013 for NVAF. For each comparison (dabigatran versus VKA and rivaroxaban versus VKA), patients were matched 1:1 on the date of the first drug (DOAC or VKA) dispensing (± 2 weeks (wks.)), gender, age at index date (± 1 year (yr)) and high-dimensional propensity score (hdPS, ± 0.05).|||participants with event|||Number
2552983|NCT02784925|Primary|Subcutaneous Fat in Steatosis Patients||up to 6 months|fatty liver patients|||cm^3||95% Confidence Interval|Mean
2552984|NCT02784834|Primary|Incidence of Dose Limiting Toxicity|The incidence of dose limiting toxicities (DLTs) will be used to define the maximum tolerated dose or biologically active dose for potential phase 2 studies.|2 months||||Participants|||Count of Participants
2552985|NCT02784704|Secondary|Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population|"Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required.~Clinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI."|TOC visit: 25-31 days after first dose of study drug|Clinically Evaluable: all randomized subjects who meet key inclusion/exclusion criteria and follow other important components of the trial|||Participants|||Count of Participants
2552986|NCT02784704|Secondary|Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the All-Treated (MITT) Population|"Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required.~Clinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI.~Indeterminate/missing was defined as an outcome that was neither a clinical cure nor clinical failure, if the investigator did not complete an assessment, if a study visit was not conducted, or if the subject died for a cause unrelated to cIAI."|TOC visit: 25-31 days after first dose of study drug|Modified Intent-to-Treat Population: all randomized subjects who receive any amount of study drug.|||Participants|||Count of Participants
2552987|NCT02784704|Primary|Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population|"Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required.~Clinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI.~Indeterminate/missing was defined as an outcome that was neither a clinical cure nor clinical failure, if the investigator did not complete an assessment, if a study visit was not conducted, or if the subject died for a cause unrelated to cIAI."|TOC visit: 25-31 days after first dose of study drug|Microbiological Intent-to-Treat Population: all randomized subjects who have at least one baseline bacterial pathogen that causes cIAI and against which the investigational drug has in vitro antibacterial activity.|||Participants|||Count of Participants
2552988|NCT02784613|Secondary|Percentage of Sexual Encounters in Which Pain Was Experienced|"For each sexual encounter, patients were required to record a ''yes or no response to the following question: Did you experience pain during intercourse? The percentage of sexual encounters in which the woman answered yes to this question at baseline (first month of the study) and at week 20 (last month of the study) was compared. The worst score possible was experiencing pain during 100% of sexual encounters and the best possible score was experiencing pain during 0% of sexual encounters at any given assessment period."|Baseline and 20 weeks|completers|||percentage of sexual encounters||Inter-Quartile Range|Median
2552989|NCT02784613|Secondary|Changes in Pain Scale|Changes in pain as noted on the pain scale (0-3) by q-tip testing of the vestibule by the clinician, with 0 representing no pain at the location and 3 being severe in each location, 1 o'clock, 3 o'clock, 5 o'clock, 6 o'clock, 7 o'clock, 9 o'clock and 11 o'clock circling the vestibule. The maximum total pain score range is 0 (no pain) to the worst score possible of 21 indicating severe pain at all locations.|Baseline and 20 weeks|Completers|||points improvement||Inter-Quartile Range|Median
2552990|NCT02784613|Primary|Visible Changes to the Vulva, Vestibule and Vaginal Region on Photography|Change in score on the Vulvoscopic Genital Tissue Appearance (VGTA) scale from baseline to 20 weeks was measured using ten parameters: 1) loss of labia majora, 2) loss of labia minora, 3) decreased glans clitoris, 4) prominence of the urethral meatus, 5) stenosis of the introitus, 6) vestibular pallor, 7) vestibular erythema, 8) loss of vestibular moisture, 9) loss of vaginal rugae, and 10) loss of prominence of the anterior vaginal wall to determine health of the vulva, vestibule and vaginal region using vulvoscopic photographs. VGTA scoring ranges from 0 (normal) to 3 (most severe) for each parameter, for a total score ranging from 0 (normal) to 30 (most severe). Each region assessed is reflected as worse for a higher score and better for a lower score in the 0-3 range, and the same for the total score, with 0 being the best possible score and 30 the worse.|Baseline and 20 weeks||||points improvement on VGTA scale||Inter-Quartile Range|Median
2552991|NCT02784587|Secondary|Rate of Atrial Fibrillation|The current rate of atrial fibrillation is measured by the Northern New England Cardiac Database, this existing database will track a-fib rates until the patients are discharged from the hospital after surgery.|Through study completion, approximately 1 year|||||||
2552992|NCT02784587|Primary|Success of Stellate Ganglion Block|Correct placement of stellate ganglion block as measured by a temperature rise of at least 1 degree Celsius in the ipsilateral hand|day of surgery||||Participants|||Count of Participants
2552993|NCT02784548|Primary|Phantom Limb Pain Questionnaire (PLPQ)|The PLPQ assesses the severity of PLP, stump pain and phantom limb sensation. Severity is assessed on a standard 11-point Likert scale pain measure, range 0-10 with higher scores indicating greater PLP.|PLPQ scores before versus after initial use of the VR treatment in the laboratory|Veterans with PLP. The mirror therapy group was a pre-specified control group that was not completed due to recruitment challenges.|||units on a scale||Standard Deviation|Mean
2552994|NCT02784275|Secondary|Change of Score in Audit of Diabetes-Dependent Quality of Life Questionnaire From Baseline|Individual 19 domains were calculated as a weighted score (WS) for each domain. Average weighted impact score = summing of WS for each domain/19 domains. Total range possible is -9 to 3, and higher number means improvement in quality of life.|12 weeks|Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 51 subjects had Week 12 ADDQoL results (9, 15, 14, and 13, respectively).|||Score on a scale||Standard Deviation|Mean
2552995|NCT02784275|Secondary|Change of Oral Glucose Tolerance Test From Baseline|Change in oral glucose tolerance test results from Day 1 to Week 12|12 weeks|Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 53 subjects had Week 12 oral glucose tolerance test results (12, 15, 14, and 12, respectively).|||mg/dL||Standard Deviation|Mean
2552996|NCT02784275|Secondary|Change of Postprandial (2 Hours After Dinner) Blood Glucose Level From Baseline|Change in postprandial (2 hours after dinner) blood glucose levels from Day 1 to Week 12|12 weeks|Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 51 subjects had Week 12 postprandial glucose values (11, 14, 14, and 12, respectively).|||mg/dL||Standard Deviation|Mean
2552997|NCT02784275|Secondary|Change in Waist Circumference From Baseline|Change in waist circumference from Day 1 to Week 12|12 weeks|Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 53 subjects had Week 12 values (12, 14, 14, and 13 respectively).|||cm||Standard Deviation|Mean
2552998|NCT02784275|Secondary|Proportion of Subjects Achieving HbA1c Goal of <6.5%|Percent of subjects who achieved HbA1c of <6% at Week 12|12 weeks|Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 54 subjects had Week 12 values (12, 15, 14, and 13, respectively).|||Participants|||Count of Participants
2552999|NCT02784275|Secondary|Proportion of Subjects Achieving HbA1c Goal of <7.0%|Percent of subjects who achieved HbA1c of <7% at Week 12|12 weeks|Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 54 subjects had Week 12 values (12, 15, 14, and 13 respectively).|||Participants|||Count of Participants
2553000|NCT02784275|Secondary|Change of Fasting Plasma Glucose Level From Baseline|Change in fasting plasma glucose from Day 1 to Week 12|12 weeks|Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 54 subjects had Week 12 values (12, 15, 14, and 13, respectively).|||mg/dL||Standard Deviation|Mean
2553001|NCT02784275|Primary|Change of Body Weight From Baseline|Change in body weight from Day 1 to Week 12|12 weeks|Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 54 subjects had Week 12 values for weight (12, 15, 14, and 13, respectively).|||kg||Standard Deviation|Mean
2553002|NCT02784275|Primary|Change of HbA1c Level From Baseline|Change in HbA1c from Day 1 to Week 12|12 weeks|Efficacy Analysis Set (N=61) was used for the efficacy analysis. However only 54 subjects had Week 12 values (12, 15, 14, and 13 subjects, respectively).|||(%)||Standard Deviation|Mean
2553003|NCT02784106|Secondary|Absolute Change From Baseline in B-cell Levels at Day 85||Baseline, Day 85|"PD Analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 measured PD endpoint, not including BTK occupancy, at a scheduled PD time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||cells per micro-liter||Standard Deviation|Mean
2553004|NCT02784106|Secondary|Absolute B-Cell Levels at Day 85||Day 85|"PD Analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 measured PD endpoint, not including BTK occupancy, at a scheduled PD time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||cells per micro-liter||Standard Deviation|Mean
2553005|NCT02784106|Secondary|Absolute Change From Baseline in Immunoglobulin Levels at Day 85|Following immunoglobulin levels were measured: Immunoglobulin A , Immunoglobulin G, Immunoglobulin G Subclass 1, Immunoglobulin G Subclass 2, Immunoglobulin G Subclass 3, Immunoglobulin G Subclass 4, Immunoglobulin M.|Baseline, Day 85|"PD Analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 measured PD endpoint, not including BTK occupancy, at a scheduled PD time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||gram/Liter||Standard Deviation|Mean
2553041|NCT02783898|Secondary|Number of Participants With Symptomatic Cardiac Rhythm Detection up to 90 Days|Symptomatic rhythm detection rate of a smart phone based event recorder for cardiac arrhythmia detection versus standard care|90 days||||Participants|||Count of Participants
2553006|NCT02784106|Secondary|Absolute Immunoglobulin Levels at Day 85|Following immunoglobulin levels were measured: Immunoglobulin A , Immunoglobulin G, Immunoglobulin G Subclass 1, Immunoglobulin G Subclass 2, Immunoglobulin G Subclass 3, Immunoglobulin G Subclass 4, Immunoglobulin M.|Baseline, Day 85|"PD Analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 measured PD endpoint, not including BTK occupancy, at a scheduled PD time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||gram/Liter||Standard Deviation|Mean
2553007|NCT02784106|Secondary|Accumulation Ratio for Observed Maximum Plasma Concentration (Racc [Cmax]) of M2951|Accumulation ratio for Cmax , was calculated as Cmax, Day 29 divided by Cmax, Day1|Pre-dose, 0.25, 0.5, 1.0, 2.0, 4.0, 6.0 hours post-dose at Day 1 and Day 29|"PK Analysis Set included all participants who receive at least 1 dose of M2951 and have at least 1 quantifiable M2951 plasma concentration at a scheduled PK time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||ratio||Standard Deviation|Mean
2553008|NCT02784106|Secondary|Accumulation Ratio for Area Under the Concentration-Time Curve From Time Zero to 6 Hours (Racc [AUC0-6h]) of M2951|Accumulation ratio for AUC was calculated as AUC 0-6h, Day 29 divided by AUC 0-6h, Day 1|Pre-dose, 0.25, 0.5, 1.0, 2.0, 4.0, 6.0 hours post-dose at Day 1 and Day 29|"PK Analysis Set included all participants who receive at least 1 dose of M2951 and have at least 1 quantifiable M2951 plasma concentration at a scheduled PK time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||ratio||Standard Deviation|Mean
2553009|NCT02784106|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of M2951||Pre-dose, 0.25, 0.5, 1.0, 2.0, 4.0, 6.0 hours post-dose at Day 1 and Day 29|"PK Analysis Set included all participants who receive at least 1 dose of M2951 and have at least 1 quantifiable M2951 plasma concentration at a scheduled PK time point post-dose. Here “Number Analyzed signified those participants who were evaluable for this endpoint at the specified time point."|||hour||Full Range|Median
2553010|NCT02784106|Secondary|Plasma Concentration Observed Immediately Before Dosing on Day 29 (Cpre) of M2951||Pre-dose on Day 29|"PK Analysis Set included all participants who receive at least 1 dose of M2951 and have at least 1 quantifiable M2951 plasma concentration at a scheduled PK time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||ng/mL||Standard Deviation|Mean
2553011|NCT02784106|Secondary|Maximum Observed Plasma Concentration (Cmax) of M2951||Pre-dose, 0.25, 0.5, 1.0, 2.0, 4.0, 6.0 hours post-dose at Day 1 and Day 29|"PK Analysis Set included all participants who receive at least 1 dose of M2951 and have at least 1 quantifiable M2951 plasma concentration at a scheduled PK time point post-dose. Here “Number Analyzed signified those participants who were evaluable for this endpoint at the specified time point."|||ng/mL||Standard Deviation|Mean
2553012|NCT02784106|Secondary|Area Under the Concentration-Time Curve From Time Zero to 6 Hours (AUC 0-6h) of M2951||Pre-dose, 0.25, 0.5, 1.0, 2.0, 4.0, 6.0 hours post-dose at Day 1 and Day 29|"PK Analysis Set included all participants who receive at least 1 dose of M2951 and have at least 1 quantifiable M2951 plasma concentration at a scheduled PK time point post-dose. Here “Number Analyzed signified those participants who were evaluable for this endpoint at the specified time point."|||hours*nanogram/milliliter||Standard Deviation|Mean
2553013|NCT02784106|Secondary|Plasma Concentration of M2951||Pre-dose at Day 1; 0.25, 0.5, 1.0, 2.0, 4.0, 6.0 hours post-dose at Day 1 and Day 29|"The Pharmacokinetic (PK) Analysis Set included all participants who receive at least 1 dose of M2951 and have at least 1 quantifiable M2951 plasma concentration at a scheduled PK time point post-dose. Here “Number Analyzed signified those participants who were evaluable for this endpoint at the specified time point."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2553014|NCT02784106|Secondary|Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings|The 12-lead ECG recordings were obtained after 10 minutes of rest in a semi-supine position. The ECG parameters obtained directly from the computerized 12-lead ECG recordings included rhythm, ventricular rate, PR interval, QRS duration, and QT interval. Clinical significance was determined by the investigator.|Baseline up to 16 Weeks|The Safety Analysis Set included all participants who received at least 1 dose of M2951 or placebo.|||Participants|||Count of Participants
2553015|NCT02784106|Secondary|Number of Participants With Clinically Significant Vital Signs Abnormalities|Vital sign assessment included blood pressure, pulse rate, respiratory rate and temperature. Clinical significance was determined by the investigator.|Baseline up to 16 Weeks|The Safety Analysis Set included all participants who received at least 1 dose of M2951 or placebo.|||Participants|||Count of Participants
2553016|NCT02784106|Secondary|Number of Participants With Grade 3 or Higher Clinically Significant Abnormality for Hematology, Biochemistry, Urinalysis or Coagulation|Clinically significant abnormalities for hematology, biochemistry or coagulation were graded with National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 toxicity grades, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening and Grade 5 = death. Participants with grade 3 or higher were reported.|Baseline up to 16 Weeks|The Safety Analysis Set included all participants who received at least 1 dose of M2951 or placebo.|||Participants|||Count of Participants
2553017|NCT02784106|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity|Grade 3 and 4 TEAES as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03) were presented. Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL).Grade 4 refers to Life-threatening consequences; where urgent intervention indicated.|Baseline up to 16 Weeks|The Safety Analysis Set included all participants who received at least 1 dose of M2951 or placebo.|||Participants|||Count of Participants
2553042|NCT02783898|Primary|Number of Participants With Symptomatic Rhythm Detection up to 90 Days|Symptomatic rhythm detection rate of a smart phone based event recorder for symptomatic rhythm detection versus standard care.|90 days||||Participants|||Count of Participants
2553095|NCT02783170|Secondary|Number of Participants With Adverse Maternal Outcomes|The number of participants with adverse maternal outcomes at delivery. Missing data is data not collected or unavailable.|Up to the 6-week postpartum visit|Safety Population - subjects randomized and received study intervention|||Participants|||Count of Participants
2553018|NCT02784106|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. TEAEs included both Serious TEAEs and non-serious TEAEs.|Baseline up to 16 Weeks|The Safety Analysis Set included all participants who received at least 1 dose of M2951 or placebo.|||Participants|||Count of Participants
2553019|NCT02784106|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on Visual Analog Scale (VAS) Score at Day 84|The Physician's Global Assessment of Disease Activity was recorded using the 100 mm horizontal VAS. Physician rated participant's arthritis disease activity on a scale ranged from 0-100 mm, where 0 indicated no disease activity (no arthritis) and 100 represented maximum disease activity (maximum arthritis).|Baseline, Day 84|"mITT analysis set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||millimeter||Standard Deviation|Mean
2553020|NCT02784106|Secondary|Change From Baseline in Self-assessment of Disability Using Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Day 84|The HAQ-DI questionnaire assessed the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, Day 84|"mITT analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
2553021|NCT02784106|Secondary|Change From Baseline in Self-assessment of Pain Based on Visual Analog Scale (VAS) Score at Day 84|The participants were asked to assess their level of pain by marking a vertical tick on a 100 mm horizontal VAS scale. The scale ranged from 0-100 mm, where 0 indicated no pain and 100 indicated worst possible pain.|Baseline, Day 84|"mITT analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||millimeter||Standard Deviation|Mean
2553022|NCT02784106|Secondary|Change From Baseline in Global Assessment of Disease Activity Based on Visual Analog Scale (VAS) Score at Day 84|The participant's overall assessment of disease activity was recorded using the 100 millimeter (mm) horizontal visual analog scale (VAS). The scale ranged from 0-100 mm, where 0 indicated no disease activity (symptom free and no arthritis symptoms) and 100 represented maximum disease activity (maximum arthritis disease activity).|Baseline, Day 84|"mITT analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose. Here, Overall Number of Participants Analyzed signified those participants who were evaluable for this outcome measure."|||millimeter||Standard Deviation|Mean
2553023|NCT02784106|Secondary|Change From Baseline in Rheumatoid Factor (RF) at Day 28 and 84|Rheumatoid Factor is an anti-body present in the blood.|Baseline, Day 28 and Day 84|"mITT analysis set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose. Here “Number Analyzed signified those participants who were evaluable for this endpoint at the specified time point."|||kiloUnit/Liter (kU/L)||Standard Deviation|Mean
2553024|NCT02784106|Secondary|Change From Baseline in Anti-cyclic Citrullinated Peptide (Anti-CCP) Antibody Levels at Day 28 and 84|Anti-cyclic citrullinated peptide (anti-CCP) is an antibody present in most rheumatoid arthritis participants.|Baseline, Day 28 and Day 84|"mITT analysis set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose. Here “Number Analyzed signified those participants who were evaluable for this endpoint at the specified time point."|||units/milliliter||Standard Deviation|Mean
2553025|NCT02784106|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 28 and 84|Erythrocyte sedimentation rate (ESR) is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. Higher values indicate inflammation in the body.|Baseline, Day 28 and Day 84|"mITT analysis set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose. Here “Number Analyzed signified those participants who were evaluable for this endpoint at the specified time point."|||millimeter/hour (mm/hour)||Standard Deviation|Mean
2553026|NCT02784106|Secondary|Proportion of Participants With Disease Activity Score- High Sensitivity C-Reactive Protein (DAS28-hsCRP) Value Less Than (<) 2.6|DAS28 consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and participant's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP =0.56* sqrt (TJC28) + 0.28*sqrt (SJC28)+ 0.014* participant's global assessment of disease activity + 0.36*natural log(hsCRP+1) +0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity. Proportion of participants with DAS28-hsCRP value <2.6 were reported.|Day 84|mITT analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose.|||proportion of participants|||Number
2553071|NCT02783573|Secondary|Population PK: Central Volume of Distribution of Lanabecestat|The central volume of distribution for lanabecestat was estimated using a population approach. No covariate effects were assessed as part of this analysis.|Predose, Week 4, 7, 19, 39, 45 and week 71 post dose|All randomized participants who received at least 1 dose of study drug with evaluable PK data.|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
2553027|NCT02784106|Secondary|Proportion of Participants With Disease Activity Score- High Sensitivity C-Reactive Protein (DAS28-hsCRP) Value Less Than (<) 3.2|DAS28-hsCRP consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and participant's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP =0.56* sqrt(TJC28) + 0.28*sqrt(SJC28)+ 0.014* participant's global assessment of disease activity + 0.36*natural log(hsCRP+1) +0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity. Proportion of participants with DAS28-hsCRP value <3.2 were reported.|Day 84|mITT analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose.|||proportion of participants|||Number
2553028|NCT02784106|Secondary|Mean Change From Baseline in Disease Activity Score Based on a 28 Joint Count High-Sensitivity C-Reactive Protein (DAS28-hsCRP) at Day 28 and 84|Disease Activity Score (DAS) based on a 28 joint count hsCRP consisted of composite numerical score of following variables: tender joint count (TJC28), swollen joint count (SJC28), hsCRP (mg/mL), and participant's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP equals to (=) 0.56*square root (sqrt) (TJC28) plus (+) 0.28*sqrt (SJC28)+ 0.014* participant's global assessment of disease activity + 0.36*natural log(hsCRP+1) +0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Day 28 and Day 84|mITT analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose.|||units on a scale||Standard Error|Mean
2553029|NCT02784106|Secondary|Mean Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Day 84|Mean change in the hsCRP concentration from baseline at Day 84 was reported.|Baseline, Day 84|mITT analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose.|||mg/mL||Standard Error|Mean
2553030|NCT02784106|Secondary|Proportion of Participants Achieving American College of Rheumatology-70 (ACR70) Response|ACR 70 response: >=70% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=70% improvement in at least 3 of the following: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function measured by HAQ-DI; and 5) acute phase reactant as measured by hsCRP. Proportion of ACR70 responders = Number of participants with ACR70 response divided by total participants.|Day 28, Day 56 and Day 84|mITT analysis set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose.|||proportion of participants|||Number
2553031|NCT02784106|Secondary|Proportion of Participants Achieving American College of Rheumatology-50 (ACR50) Response|ACR 50 response: >=50% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=50% improvement in at least 3 of the following: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function measured by HAQ-DI; and 5) acute phase reactant as measured by hsCRP. Proportion of ACR50 responders = Number of participants with ACR50 response divided by total participants.|Day 28, Day 56 and Day 84|mITT analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose.|||proportion of participants|||Number
2553032|NCT02784106|Secondary|Mean Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Day 28|Mean change in the hsCRP concentration from baseline at Day 28 was reported.|Baseline, Day 28|mITT analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose.|||milligram/milliliter (mg/mL)||Standard Error|Mean
2553033|NCT02784106|Primary|Proportion of Participants Who Achieved American College of Rheumatology-20 (ACR20) Response|ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=20% improvement in at least 3 of the following: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI); and 5) acute phase reactant as measured by high-sensitivity C-reactive protein (hsCRP). Proportion of ACR20 responders = Number of participants with ACR20 response divided by total participants.|Day 84|The Modified Intent-to-Treat (mITT) Analysis Set included all participants who received at least 1 dose of M2951 or placebo and have at least 1 available ACR20 evaluation at a time point post-dose.|||proportion of participants|||Number
2553034|NCT02783898|Secondary|Number of Participants Completing Questionnaire|Measure of questionnaire compliance - Number of participants completing questionnaire|90 days||||Participants|||Count of Participants
2553035|NCT02783898|Secondary|Number of Participants With Serious Outcome up to 90 Days|Number of patients with all cause death and/or major adverse cardiac events (MACE; myocardial infarction, life threatening arrhythmia, insertion of pacemaker or internal cardiac defibrillator, insertion of pacing wire).|90 days||||Participants|||Count of Participants
2553036|NCT02783898|Secondary|Financial Cost Per Diagnosis of Symptomatic Rhythm|Financial cost per diagnosis of symptomatic rhythm using smart phone based event recorder versus standard care.|90 days||||British pounds||Full Range|Median
2553037|NCT02783898|Secondary|Number of Participants Finding the AliveCor Heart Monitor Easy to Use|Number of Participants answering the participant questionnaire and finding the AliveCor heart monitor easy to use|90 days||||Participants|||Count of Participants
2553038|NCT02783898|Secondary|Number of Participants Treated or (Planned for Treatment) for Cardiac Arrhythmia|Number of participants treated or (planned for treatment) for cardiac arrhythmia in participants using a smart phone based event recorder versus standard care|90 days||||Participants|||Count of Participants
2553039|NCT02783898|Secondary|Time to Detection of Cardiac Arrhythmia Rhythm|Time to detection of cardiac arrhythmia rhythm using a smart phone based event recorder versus standard care|90 days||||days||Standard Deviation|Mean
2553040|NCT02783898|Secondary|Time to Detection of Symptomatic Rhythm|Time to detection of symptomatic rhythm using a smart phone based event recorder versus standard care|90 days||||days||Standard Deviation|Mean
2553043|NCT02783729|Other Pre-specified|Change From Baseline in Mean Quality of Memory (QOM) and Continuity of Attention (COA) on Days 2/3|QOM represents the ability to store information in memory and subsequently retrieve it. It is a composite score created by combining accuracy measures from 2 sets of working memory and 4 sets of episodic memory. Two sets of working memory were included: numerical and spatial working memory, and ranges from -2 to 2. Four sets of episodic memory were included: immediate and delayed word recall, and word and picture recognition, and ranges from -200 to 400. COA is the ability to sustain attention. Number of correct responses (out of 50) for choice reaction time was added to total number of targets correctly identified (out of 45) digit vigilance minus number of false alarms (total score of -45 to 95). Higher values were better. Change from baseline to average QOM and COA on Days 2 and 3 was reported.|Baseline, Days 2/3|FAS was group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose efficacy measurement at given time points.|||units on scale||Standard Deviation|Mean
2553044|NCT02783729|Other Pre-specified|Change From Baseline in Mean Power of Attention (POA) and Speed of Memory Retrieval (SOMT) on Days 2/3|POA reflects the ability to focus attention and process information. POA is calculated from the sum of simple reaction time, choice reaction time and digit vigilance. SOMT reflects time taken to retrieve information from working and episodic memory. SOMT is a composite score created by combining numerical working memory and spatial working memory and word recognition and picture recognition. Cognitive performance assessment was done by a computerized performance assessment battery (PAB) which was administered on a laptop computer. A positive change from baseline reflects impairment and a lower value of decrease from baseline indicates better performance. Change from baseline to average POA and SOMT on Days 2 and 3 was reported.|Baseline, Days 2/3|FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points.|||millisecond||Standard Deviation|Mean
2553045|NCT02783729|Other Pre-specified|Change From Baseline in Fatigue Severity Scale (FSS) Score of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER and Placebo on Day 31|"The FSS is a self-report scale on which participants are instructed to choose a number from 1 to 7 that indicates their degree of agreement with each of 9 statements about their fatigue where 1 indicates strongly disagree, and 7 indicates strongly agree. The FSS total score was the sum of all responses to the 9 questions. The FSS average item score was the average of the score for each item. Higher total scores and higher average item scores indicated greater fatigue."|Baseline and Day 31|FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points.|||score on scale||Standard Deviation|Mean
2553046|NCT02783729|Other Pre-specified|Change From Baseline in Score From Items 4 to 7 on the Insomnia Severity Index (ISI) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER and Placebo on Day 31|The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated were: severity of sleep onset; sleep maintenance; early morning awakening problems; sleep dissatisfaction; interference of sleep difficulties with daytime functioning; noticeability of the sleep problems by others; and distress caused by the sleep difficulties. A 5-point Likert scale was used to rate each item (from 0 = no problem to 4 = very severe problem) yielding a total score from 0 to 28.|Baseline and Day 31|FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points.|||score on scale||Standard Deviation|Mean
2553047|NCT02783729|Other Pre-specified|Percentage of Responders With Objective and Subjective Sleep Onset Response, and Objective and Subjective Sleep Maintenance Response|Objective sleep onset response: LPS less than or equal to (<=) 20 minutes (mins) provided baseline LPS was greater than (>) 30 mins. Subjective sleep onset response: sSOL <=20 mins provided mean baseline sSOL was >30 mins. Objective sleep maintenance response: WASO <=60 minutes provided baseline WASO was >60 mins and was reduced by >10 mins compared to baseline. Subjective sleep maintenance response: sWASO <=60 mins provided mean WASO was >60 mins and was reduced by >10 mins compared to baseline. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals. Average data for Days 1 and 2, Days 29 and 30, and first and last 7 nights of treatment period was reported.|Days 1/2, Days 29/30, first 7 night (approximately Week 1), and Last seven nights (approximately Week 4)|FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points.|||percentage of participants|||Number
2553048|NCT02783729|Other Pre-specified|Change From Baseline in Mean sSE of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo|sSE: percentage of sTST per subjective time spent in bed asleep, calculated as the interval from the time attempted to sleep to time stopped trying to sleep for the night, and time spent asleep derived from subjective time spent in bed minus sWASO. sWASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. sSE was analyzed with DHR on an electronic sleep diary. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals.|First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4)|FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points.|||% of subjective time in bed asleep||Standard Deviation|Mean
2553049|NCT02783729|Other Pre-specified|Change From Baseline in Mean sSOL, sWASO, and sTST of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo|sSOL: estimated minutes from time attempted to sleep to sleep onset. sWASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. sSOL, sWASO, sTST were analyzed with DHR on an electronic sleep diary. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals.|First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4)|FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points.|||minutes||Standard Deviation|Mean
2553072|NCT02783573|Secondary|Population Pharmacokinetics (PK): Apparent Oral Clearance of Lanabecestat|The apparent oral clearance of lanabecestat was estimated using a population approach. No covariate effects were assessed as part of this analysis.|Predose, Week 4, 7, 19, 39, 45 and Week 71 post dose|All randomized participants who received at least 1 dose of study drug with evaluable PK data.|||Liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2553050|NCT02783729|Other Pre-specified|Change From Baseline in Mean WASO2H and TST of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30|WASO2H is defined as the time in minutes of wake during the interval from 240 minutes after lights off until lights on. TST is defined as the amount of sleep in minutes from sleep onset until terminal awakening. WASO and TST were measured by PSG. Change from baseline to average WASO and TST on Day 29 and 30 were reported.|Baseline, Days 29/30|FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points.|||minutes||Standard Deviation|Mean
2553051|NCT02783729|Other Pre-specified|Change From Baseline in Mean SE of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 1/2|SE is defined as percentage of time spent in bed asleep, calculated as TST divided by interval from lights off until lights on as measured by PSG, multiplied by 100. Change from baseline to average SE on Day 1 and 2 were reported.|Baseline, Days 1/2|FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement.|||Percentage of time in bed asleep||Standard Deviation|Mean
2553052|NCT02783729|Other Pre-specified|Change From Baseline in Mean LPS, WASO, WASO2H, and TST of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 1/2|LPS: amount of time in minutes from lights off to first epoch of 20 consecutive epochs of non-wakefulness. WASO: amount of time in minutes of wake from the onset of persistent sleep until lights. WASO2H: amount of time in minutes of wake during the interval from 240 minutes after lights off until lights on. TST: amount of time in minutes of sleep from sleep onset until terminal awakening. LPS, WASO, WASO2H, and TST were measured by PSG. Change from baseline to average LPS, WASO, WASO2H, and TST on Day 1 and 2 were reported.|Baseline, Days 1/2|FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement.|||minutes||Standard Deviation|Mean
2553053|NCT02783729|Other Pre-specified|Change From Baseline in Subjective Sleep Efficiency (sSE) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER|sSE: percentage of sTST per subjective time spent in bed asleep, calculated as the interval from the time attempted to sleep to time stopped trying to sleep for the night, and time spent asleep derived from subjective time spent in bed minus sWASO. sWASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. sSE was analyzed with DHR on an electronic sleep diary. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals.|First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4)|FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points.|||% of subjective time in bed asleep||Standard Deviation|Mean
2553054|NCT02783729|Other Pre-specified|Change From Baseline in Subjective Sleep Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO) and Subjective Total Sleep Time (sTST) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER|sSOL: estimated minutes from time attempted to sleep to sleep onset. sWASO: estimated minutes of wake at night after initial sleep onset to time stopped trying to sleep for the night. sTST: minutes of sleep from sleep onset to time stopped trying to sleep for the night. sSOL, sWASO, sTST were analyzed with diary handling rules (DHR) on an electronic sleep diary. Subjective measures were derived from sleep diaries entries, collected daily and analyzed at appropriate intervals.|First 7 nights (approximately Week 1) and Last 7 nights (approximately Week 4)|FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points.|||minutes||Standard Deviation|Mean
2553055|NCT02783729|Other Pre-specified|Change From Baseline in Mean LPS, WASO, and TST of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER on Days 1/2 and Days 29/30|LPS is defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non-wakefulness as measured by the PSG. WASO is defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG. TST is defined as the amount of sleep in minutes from LPS until terminal awakening as measured by PSG. Change from baseline to average LPS, WASO, and TST on Days 1 and 2, and Days 29 and 30 were reported.|Baseline, Days 1/2, and Days 29/30|FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points.|||minutes||Standard Deviation|Mean
2553056|NCT02783729|Other Pre-specified|Change From Baseline in Mean Body Sway Upon Awakening in the Morning for Lemborexant 5 mg and Lemborexant 10 mg Compared to Zolpidem ER on Days 2/3|Body sway is detected through a cable around the participant's waist by the ataxia meter. Body sway is measured in units of one-third degree of the angle of arc. For ease in reporting, these are called arbitrary units, with a higher number indicating more body sway (less postural stability). Change from baseline in mean body sway on Days 2 and 3 was reported.|Baseline, Days 2/3|The FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points.|||one-third degree of angle of arc||Standard Deviation|Mean
2553057|NCT02783729|Secondary|Change From Baseline in WASO in the Second Half of the Night (WASO2H) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Zolpidem ER on Days 29/30|WASO2H is defined as time in minutes of wake during the interval from 240 minutes after lights off until lights on as measured by PSG. Change from baseline to average WASO2H on Days 29 and 30 was reported.|Baseline, Days 29/30|FAS was the group of randomized Participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points.|||minutes||Standard Deviation|Mean
2553058|NCT02783729|Secondary|Change From Baseline in Mean Wake After Sleep Onset (WASO) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30|WASO is defined as minutes of wake from the onset of persistent sleep until lights on as measured by PSG. Change from baseline to average WASO on Days 29 and 30 was reported.|Baseline, Days 29/30|FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points.|||minutes||Standard Deviation|Mean
2553092|NCT02783170|Secondary|Percentage of Participants With Histologic Chorioamnionitis on Surgical Pathology Examination of Placental Tissue|Percentage of participants with histologic chorioamnionitis on surgical pathology examination of placental tissue|after delivery, approximately up to 2 weeks|Safety Population - subjects randomized and received study intervention|||percentage of participants|||Number
2553059|NCT02783729|Secondary|Change From Baseline in Mean Sleep Efficiency (SE) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30|SE is defined as percentage of time spent in bed asleep, calculated as total sleep time (TST) divided by interval from lights off until lights on as measured by PSG, multiplied by 100. Change from baseline to average SE on Day 29 and 30 was reported.|Baseline, Days 29/30|The FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points.|||Percentage of time in bed asleep||Standard Deviation|Mean
2553060|NCT02783729|Primary|Change From Baseline in Mean Latency to Persistent Sleep (LPS) of Lemborexant 10 mg and Lemborexant 5 mg Compared to Placebo on Days 29/30|LPS is defined as the time in minutes from lights off to the first epoch of 20 consecutive epochs of non- wakefulness as measured by PSG. Change from baseline to average LPS on Day 29 and 30 was reported.|Baseline, Days 29/30|FAS was the group of randomized participants who received at least 1 dose of randomized study drug and had at least 1 postdose primary efficacy measurement at given time points.|||minutes||Standard Deviation|Mean
2553061|NCT02783599|Secondary|Number of Participants With Anti-Olaratumab Antibodies|A participant is counted as positive if they had at least one anti-olaratumab antibody positive result during the study.|Predose Cycle 1 Day 1 through Follow-Up (Up to 8 Months)|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2553062|NCT02783599|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab|Cmax of olaratumab Cycles 2 and 3 Day 1 and 8 of a 21-day cycle.|Cycle 2 Day 1: Predose, 5 minutes(m) post-infusion, 24 hours(h), 96h; Day 8:Predose, 5 m, and 24h, 48h, 96h, and 240h postdose; Cycle 3 Day 1 and Day 8: Predose and 5m post-infusion|All participants who received at least one dose of study drug and had evaluable PK data.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2553063|NCT02783599|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Olaratumab Monotherapy|Summary of Cmax of olaratumab monotherapy on Cycle 1 Day 1 and Day 8|Cycle 1 Days 1 and 8: Predose; 5 minutes(m) post-infusion|All participants who received at least one dose of study drug and had evaluable PK data.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2553064|NCT02783599|Secondary|Percentage of Participants With Resectable Tumors (Resectability Rate)|Resectability rate is obtained when the total number of participants with resectable tumors is divided by the total number of participants. Resectability of a tumor is determined by the surgeon and multi-disciplinary team and dependent on tumor stage and the participants coexisting medical conditions.|Cycle 1 through Cycle 7 (Up to 6 Months)|All participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2553065|NCT02783599|Secondary|Disease Control Rate (DCR): Percent of Participants Who Exhibit Stable Disease (SD), CR or PR|"Disease control rate (DCR) is defined as the percentage of participants achieving a best overall response of CR, PR, or SD as determined by RECIST 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters; SD is defined as neither sufficient shrinking to qualify as PR nor sufficient increase to qualify for PD.~Participants who do not have any post-baseline tumor response assessments for any reason are considered non-responders and are included in the denominator when calculating the response rate."|Baseline to Measured Progressive Disease (Up to 18 Months)|All participants who received at least one dose of study drug.|||percentage of participants|||Number
2553066|NCT02783599|Secondary|Objective Response Rate (ORR): Percent of Participants With Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR)|Overall Response Rate (ORR) is defined as the percentage of participants achieving a best overall response of either Complete Response (CR) or Partial Response (PR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. The best overall response is the best response from the start of the treatment until progressive disease (PD)/recurrence.|Baseline to Measured Progressive Disease (Up to 18 Months)|All participants who received at least one dose of study drug.|||percentage of participants|||Number
2553067|NCT02783599|Secondary|Progression Free Survival (PFS)|Progression-free survival (PFS) is defined as the time from the date of first study dose to the first date of radiologic disease progression or death due to any cause. Progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions is also considered progression.|Baseline to Objective Progression or Death from Any Cause (Up to 18 Months)|All participants who received at least one dose of study drug.|||months||95% Confidence Interval|Median
2553068|NCT02783599|Primary|Percent Change From Baseline in Gene Expression of PDGF A, PDGF B, PDGF C, and PDGF-D Canonical Ligands in Tumor Tissue|PDGF A, PDGF B, PDGF C, and PDGF D are platelet-derived growth factor canonical ligands associated with activation of PDGFR α and β.|Baseline, End of Cycle 1 (21 days)|All participants who received at least one dose of study drug and had evaluable baseline tissue samples at baseline and post-olaratumab monotherapy.|||percent change in gene expression||Standard Deviation|Mean
2553069|NCT02783599|Primary|Percent Change From Baseline in Gene Expression of Platelet-Derived Growth Factor Receptor Alpha (PGDFRα) and PGDFR Beta (β) in Tumor Tissue|Over-activity of PDGF signaling is associated with the development of certain malignant diseases. Olaratumab is an IgG1 antagonist of PDGFRα.|Baseline, End of Cycle 1 (21 days)|All participants who received at least one dose of study drug and had evaluable tissue samples at baseline and post-olaratumab monotherapy.|||percent change in gene expression||Standard Deviation|Mean
2553070|NCT02783599|Primary|Percent Change From Baseline in Enumeration of Circulating Tumor Cells (CTCs) in Whole Blood|Enumeration of CTCs pre- and post- treatment with olaratumab may be a useful biomarker given the predilection for sarcomas to spread hematogenously.|Baseline, End of Cycle 1 (21 days)|All participants who received one cycle of study drug and had evaluable blood samples for CTCs at baseline and post-olaratumab monotherapy.|||percent change||Standard Deviation|Mean
2553073|NCT02783573|Secondary|Change From Baseline in Whole Brain Volume|Magnetic resonance imaging (MRI) was used to evaluate the effect of lanabecestat on brain atrophy/whole brain volumes. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, baseline volumetric magnetic resonance imaging (vMRI), intracranial volume and age at baseline.|Baseline, Week 78|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for Whole Brain Volume.|||cm^3 (cubic centimeter)||Standard Error|Least Squares Mean
2553074|NCT02783573|Secondary|Change From Baseline in Regional Cerebral Blood Flow (rCBF) Using Florbetapir Perfusion Scan|Florbetapir perfusion evaluated the regional cerebral blood flow (rCBF) as a biomarker of brain function and was performed at the same time as the amyloid florbetapir PET. Cerebral perfusion, especially in temporal and parietal areas, is reduced in AD and this pattern of hypoperfusion closely mirrors the hypometabolism pattern observed using FDG PET. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA with LOCF (last observation carried forward) and with factors for treatment, baseline biomarker and age at baseline.|Baseline, Week 78|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for rCBF.|||Standard Uptake Value ratio (SUVr)||Standard Error|Least Squares Mean
2553075|NCT02783573|Secondary|Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan|Amyloid deposition in the brain is one of the defining neuropathologic findings of Alzheimer's disease. Florbetapir exhibits high affinity specific binding to amyloid plaques. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by florbetapir amyloid PET imaging in a subset of participants. The Centiloid scale standardizes quantitative brain amyloid PET results to allow cross-tracer and cross-methodology comparisons. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scans. Florbetapir SUVr was converted to the Centiloid scale using the following conversion: Florbetapir Centiloids = 183 x SUVr - 177. LS Mean was determined by using ANCOVA methodology with terms for treatment, baseline biomarker and age at baseline.|Baseline, Week 78|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for brain amyloid burden.|||Units on a scale||Standard Error|Least Squares Mean
2553076|NCT02783573|Secondary|Change From Baseline in CSF Biomarker Phosphorylated Tau|Cerebrospinal fluid samples are collected for analysis of concentration of phosphorylated tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, baseline biomarker and age at baseline.|Baseline, Week 71|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for CSF Phosphorylated Tau.|||Picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
2553077|NCT02783573|Secondary|Change From Baseline in CSF Biomarker Total Tau|Cerebrospinal fluid samples were collected for analysis of concentration total tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, baseline biomarker and age at baseline.|Baseline, Week 71|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for CSF Total Tau.|||Picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
2553078|NCT02783573|Secondary|Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40|Concentration of the peptide Aβ 1-40 in plasma measured by immunoassay. LS Mean was determined by ANCOVA with LOCF (last observation carried forward), terms for treatment, baseline biomarker and age at baseline.|Baseline, Week 71|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for Aβ1-40.|||Percent change in Aβ1-40||Standard Error|Least Squares Mean
2553079|NCT02783573|Secondary|Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42|Concentration of the peptide Aβ 1-42 in plasma measured by validated immunoassay. LS Mean was determined by Analysis of covariance (ANCOVA) with last observation carried forward (LOCF), terms for treatment, baseline biomarker and age at baseline.|Baseline, Week 71|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for Aβ1-42.|||Percent change in Aβ1-42||Standard Error|Least Squares Mean
2553080|NCT02783573|Secondary|Change From Baseline on the Mini-Mental State Examination (MMSE)|The MMSE is an instrument used to assess a participant's global cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline MMSE total score, age at baseline, and baseline MMSE total score-by-visit interaction.|Baseline, Week 78|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for MMSE.|||Units on a scale||Standard Error|Least Squares Mean
2553081|NCT02783573|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Score|The NPI is a questionnaire administered to caregivers that quantifies behavioral changes. Each of the 12 behavioral domains the caregiver reports as present are scored for Frequency, scale: 1 (Occasionally) to 4 (Very Frequently), and Severity, scale: 1 (Mild) to 3 (Severe). If the domain is reported by the caregiver as 'Not Affected,' that domain is scored as 0. The individual domain scores are calculated by multiplying the frequency times the severity for each domain. NPI Total Score is calculated by adding the individual domain scores together for all 12 domains, with a scores range from 0 to 144, with higher scores indicating a greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline NPI score, age at baseline, and baseline NPI score-by-visit interaction.|Baseline, Week 78|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for NPI.|||Units on a scale||Standard Error|Least Squares Mean
2553093|NCT02783170|Secondary|Percentage of Participants With Clinical Chorioamnionitis|Percentage of participants with clinical chorioamnionitis|at the time of delivery|Safety Population - subjects randomized and receiving study intervention|||percentage of participants|||Number
2553082|NCT02783573|Secondary|Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage|The CDR global score is a composite score calculated using the Washington University CDR-assignment algorithm applied to the 6 individual domain box scores (Morris 1993). The memory domain is considered the primary category that drives the CDR global outcome, and all other domains are secondary. The CDR global score ranges from 0 to 3 (0 = no dementia, 0.5 = questionable dementia, 1 = mild dementia, 2 = moderate dementia, 3 = severe dementia).|From Loss of 1 Global Stage through Week 78|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for CDR global score.|||Days||95% Confidence Interval|Median
2553083|NCT02783573|Secondary|Change From Baseline in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score|"The CDR-SB is a rater administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which no dementia = 0, questionable dementia = 0.5, mild dementia = 1, moderate dementia = 2 and severe dementia = 3. The 6 individual category ratings, or box scores, were added together to give the CDR-Sum of Boxes which ranges from 0-18, with higher scores indicating greater impairment. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline CDR-SB score, age at baseline, and baseline CDR-SB score-by-visit interaction."|Baseline, Week 78|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for CDR-SB.|||Units on a scale||Standard Error|Least Squares Mean
2553084|NCT02783573|Secondary|Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score|The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline iADRS13 total score, age at baseline, and baseline iADRS13 total score-by-visit interaction.|Baseline, Week 78|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for iADRS.|||Units on a scale||Standard Error|Least Squares Mean
2553085|NCT02783573|Secondary|Change From Baseline in Functional Activities Questionnaire (FAQ) Score|FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from writing checks, assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now=1; never did [the activity] but could do now=0; normal=0; has difficulty but does by self=1; requires assistance=2; Dependent =3). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean determined by MMRM model with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline FAQ total score, by-visit interaction and age at baseline.|Baseline, Week 78|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for FAQ score.|||Units on a scale||Standard Error|Least Squares Mean
2553086|NCT02783573|Secondary|Change From Baseline in Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items Score (ADCS-iADL)|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM model with factors for treatment, visit, treatment-by-visit interaction, AChEI use at baseline, pooled site, and covariates for baseline iADL score, age at baseline, and baseline iADL score-by-visit interaction.|Baseline, Week 78|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADCS-iADL measure.|||Units on a scale||Standard Error|Least Squares Mean
2553087|NCT02783573|Primary|Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog13) Score|ADAS-Cog13 (13-item version of ADAS Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment-by-visit interaction, acetylcholinesterase Inhibitor (AChEI) use at baseline, pooled site, and covariates for baseline ADAS-Cog13 total score, age at baseline, and baseline ADAS-Cog13 total score-by-visit interaction.|Baseline, Week 78|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADAS-Cog13 measure.|||Units on a scale||Standard Error|Least Squares Mean
2553088|NCT02783443|Primary|Change in Perfused Boundary Region (PBR)|PBR is an indirect measure of glycocalyx thickness|Change from baseline PBR at 24 hours after surgery||||micrometer||Standard Deviation|Mean
2553089|NCT02783170|Secondary|Feasibility as Measured by Percentage of Testable Blood Samples Completed|Percentage of testable (sufficient volume and quality) blood samples completed|Approximately 1 year|Safety Population - subjects randomized and received study intervention|||percentage of samples|||Number
2553090|NCT02783170|Secondary|Feasibility as Measured by Percentage of Blood Samples in With Sufficient Volume for Testing|Percentage of blood samples received with sufficient volume for testing|Approximately 1 year|Safety Population - subjects randomized and received study intervention|||percentage of samples|||Number
2553091|NCT02783170|Secondary|Feasibility as Measured by Percentage of Blood Samples in Testable Condition|Percentage of blood samples received in testable condition (sufficient volume and quality)|Approximately 1 year|Safety Population - subjects randomized and received study intervention|||percentage of samples|||Number
2560614|NCT02662569|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2553098|NCT02783170|Primary|Feasibility Reported as Percentage of Reactogenicity Data Collected|Percentage of reactogenicity data days reported (days reported / total possible days)|Approximately 1 year|Safety Population - subjects randomized and received study intervention|||percentage of days|||Number
2553099|NCT02783170|Primary|Feasibility as Measured by Participant Retention (Percentage of Participants Who Complete All Visits)|Percentage of participants that completed all in-person and delivery visits|Approximately 1 year|Safety Population - subjects randomized and received study intervention|||percentage of participants|||Number
2553100|NCT02783170|Primary|Percentage of Subjects Recruited Enrollment Period|Percentage of subjects recruited during 4 month enrollment period|Approximately 1 year|All subjects recruited and enrolled in the study|||percentage of participants|||Number
2553101|NCT02783170|Primary|Percentage of Subjects With Seroprotection as Determined by Influenza Serum Antibody Levels (≥1:40) (Pre- and Post-immunization) and Seroconversion (4-fold Rise From Baseline or a Change From <1:10 to ≥1:40) )|Measurement of serum antibody levels to influenza antigens in maternal blood and infant cord blood obtained at delivery|Pre and 21 days post vaccination and at Delivery|Safety Population - subjects receiving the study intervention. Participants analyzed include those that provided data.|||percentage of participants||95% Confidence Interval|Number
2553102|NCT02783170|Primary|Percentage of Subjects With Seroprotection as Determined by Tetanus Serum Antibody Levels (Defined as ≥ 0.1 IU/mL)|Measurement of serum antibody levels to tetanus toxoids, in maternal blood pre- and post-vaccination, maternal blood at delivery and infant cord blood obtained at delivery|21 days post vaccination|Safety Population - all subjects receiving the study intervention. Participants analyzed include those that provided data.|||percentage of participants||95% Confidence Interval|Number
2553103|NCT02783170|Primary|Percentage of Subjects With Seroprotection as Determined by Diphtheria Serum Antibody Levels (Defined as ≥ 0.1 IU/mL)|Measurement of serum antibody levels to diphtheria toxoids, in maternal blood pre- and post-vaccination, maternal blood at delivery and infant cord blood obtained at delivery|Pre vaccination and approximately 21 days post vaccination and at Delivery|Safety Population - subjects that were randomized and received the study intervention. Participants analyzed include those that provided data.|||percentage of participants||95% Confidence Interval|Number
2553104|NCT02783170|Primary|Pertussis Serum Antibody Levels, as Measured by Geometric Mean Titers|Measurement of serum antibody levels to pertussis antigens, in maternal blood pre- and post-vaccination, maternal blood at delivery and infant cord blood obtained at delivery|Pre-vaccination and approximately 21 days post vaccination and at Delivery|Safety Population - subjects that were randomized and received the study intervention. Participants analyzed include those that provided data.|||Concentration (IU/mL)||95% Confidence Interval|Geometric Mean
2553105|NCT02783170|Primary|Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 4|Percentage of systemic reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid|8 days post vaccine administration|Safety Population - subjects that were randomized and received the study intervention. Participants analyzed include those that provided data.|||percentage of participants||95% Confidence Interval|Number
2553106|NCT02783170|Primary|Percentage of Participants With Systemic Reactions Post Tdap and IIV4 Administration - Visit 1|Percentage of systemic reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid|8 days post vaccine administration|Safety Population - subjects that were randomized and received the study intervention. Participants analyzed include those that provided data.|||percentage of participants||95% Confidence Interval|Number
2553107|NCT02783170|Primary|Percentage of Participants With Injection-site Reactions Post Tdap and IIV4 Administration|Percentage of injection-site reactions will be compared in simultaneous and sequential groups as determined by self-assessment via memory aid|8 days post vaccine administration|Safety Population - subjects that were randomized and received the study intervention|||percentage of participants||95% Confidence Interval|Number
2553108|NCT02783027|Secondary|Inter-Shift Recovery|The Occupational Fatigue Exhaustion Recovery Scale Inter-shift Recovery Subscale. Scores range from 0 to 100. Scores 50-100 imply moderate to high recovery.|4 months|Participants with survey data at 4 months.|||score on a scale||Standard Deviation|Mean
2553109|NCT02783027|Secondary|Difficulty With Concentration During Shiftwork|Single item measure of difficulty with concentration taken at beginning, every 4-hours, and at the end of shifts. Scores range from 0 (Not at all) to 5 (Very much). Higher scores indicate more difficulty with concentration.|Every 4 hours up to 12 hours at end of work shift|Number with shift data at 30 days|||score on a scale||95% Confidence Interval|Least Squares Mean
2553110|NCT02783027|Secondary|Sleepiness During Shiftwork|Single item measure of sleepiness taken at beginning, every 4-hours, and at the end of shifts. Scores range from 0 (Not at all) to 5 (Very much). Higher scores indicate more sleepiness.|Every 4 hours up to 12 hours within a work shift|Individuals with shift data up to 30 days|||score on a scale||95% Confidence Interval|Least Squares Mean
2553111|NCT02783027|Secondary|Fatigue During Shiftwork|Single item measure of fatigue taken at beginning, every 4-hours, and at the end of shifts. Scores range from 0 (Not at all) to 5 (Very much); higher scores indicate more fatigue.|Every 4 hours up to 12 hours within work shifts|Participants with at least some intra-shift data on fatigue.|||score on a scale||95% Confidence Interval|Least Squares Mean
2553112|NCT02783027|Primary|Sleep Quality|Measured by the Pittsburgh Sleep Quality Index (PSQI); Scores range from 0 to 21. Higher scores indicate poorer sleep quality. Scores >6 indicate poor sleep quality.|4 months|Individuals with outcome measured at 4 months.|||score on a scale||Standard Deviation|Mean
2553113|NCT02782923|Primary|Change in Number of Off-road Excursions (ORE)|"Number of off-road excursions was measured by the number of times the patient's vehicle traversed the lateral road edge and traveled off onto the grass"|Baseline, 3 months||||off-road excursions||Full Range|Median
2553114|NCT02782923|Primary|Change in Number of Centerline Crossings (CC)|"Change from baseline in the number of unsafe lane changes. Measured by the number of times the patient failed to check blind spots when changing lanes or changed lanes when another vehicle was in the patient's blind spot."|Baseline, 3 months||||centerline crossings||Full Range|Median
2553115|NCT02782923|Primary|Change in Number of Total Collisions (TC)|"Change from Baseline in Overall collisions (BL-3mo). Includes both off-road and on-road collisions."|Baseline, 3 months||||collisions/crashes||Full Range|Median
2553116|NCT02782676|Secondary|Grade of Inflammation: Fibrin Presence|The grades of inflammation for Fibrin Presence was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.|Upto 3 Months|"The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis~Number of eyes analyzed for Control OVD at 1 month and 3 months were less than the overall number analyzed because one subject was lost to follow up."|||eyes|eyes||Count of Units
2553117|NCT02782676|Secondary|Grade of Inflammation: Posterior Synechiae|The grades of inflammation for Posterior Synechiae was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.|Upto 3 Months|"The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis~Number of eyes analyzed for Control OVD at 1 month and 3 months were less than the overall number analyzed because one subject was lost to follow up."|||eyes|eyes||Count of Units
2553118|NCT02782676|Secondary|Grade of Inflammation: Anterior Synechiae|The grades of inflammation for Anterior Synechiae was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.|Upto 3 months|"The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis~Number of eyes analyzed for Control OVD at 1 month and 3 months were less than the overall number analyzed because one subject was lost to follow up."|||eyes|eyes||Count of Units
2553119|NCT02782676|Secondary|Grade of Inflammation: Flare|The grades of inflammation for flare was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.|Upto 3 months|"The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis~Number of eyes analyzed for Control OVD at 1 month and 3 months were less than the overall number analyzed because one subject was lost to follow up."|||eyes|eyes||Count of Units
2553120|NCT02782676|Secondary|Grade of Inflammation: Cells|The grades of inflammation for cells was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.|Upto 3 months|"The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis~Number of eyes analyzed for Control OVD at 1 month and 3 months were less than the overall number analyzed because one subject was lost to follow up."|||eyes|eyes||Count of Units
2553121|NCT02782676|Secondary|Grade of Inflammation: Stromal Edema|The grades of inflammation for stromal edema was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.|Upto 3 months|"The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis~Number of eyes analyzed for Control OVD at 1 month and 3 months were less than overall number analyzed because one subject was lost to follow up."|||eyes|eyes||Count of Units
2553122|NCT02782676|Secondary|Grade of Inflammation: Epithelial Edema|The grades of inflammation for epithelial edema was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.|Upto 3 months|"The safety population consists of all subjects who had any study OVD used and with data available at the time of analysis~Number of eyes analyzed for Control OVD at 1 month and 3 months were less than the overall number analyzed because one subject was lost to follow up."|||eyes|eyes||Count of Units
2553123|NCT02782676|Secondary|Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively|The rate of IOP spike 30 mmHg or greater at 6 hour, 1 day, 1 week, 1 month and 3 months postoperatively was tabulated with frequency and proportion by OVD group.|3 months|Results are based on paired-eye subjects included in the safety population.|||eyes|eyes||Count of Units
2553124|NCT02782676|Secondary|Mean Change in IOP From Baseline|The mean change in IOP from baseline for both OVD groups over time at the 6 hour, 1 day, 1 week, 1 month, and 3 month postoperative time points are presented.|3 months|Results are based on paired-eye subjects included in the safety population.|||mmHg|eyes|Standard Deviation|Mean
2553125|NCT02782676|Secondary|Ocular Serious Adverse Events (SAE)|"Ocular serious and/or device related adverse event rates was be tabulated with the frequency and proportion of eyes with these events reported over time and cumulatively by OVD group.~* in the results table denotes SAEs determined to be device-related"|3 months|The results are consist of all subjects who had any study OVD used and with data available at the time of analysis.|||Eyes|Eyes||Count of Units
2553126|NCT02782676|Primary|Mean Percent Endothelial Cell Count (ECC) Change Preoperatively vs. Postoperatively|The mean percent ECC change with the bacterially-derived Healon5 will be statistically non-inferior to that with the animal-derived Healon5 control using a non-inferiority margin of 5%.|3 months|Results are based on paired-eye subjects included in the safety population, which differs from the total number of participant (paired + non-paired eyes) safety population used in the Participant Flow. ECC photos were taken outside of the 3-month visit window for two subjects; therefore, the data was excluded from the analysis.|||percent change||95% Confidence Interval|Mean
2553127|NCT02782676|Primary|Cumulative Rates of Intraocular Pressure (IOP) Spikes 30mm of Mercury (mmHg) or Greater Measured Postoperatively|The cumulative rate of IOP spikes with the bacterially-derived Healon5 will be statistically non-inferior to that with the animal-derived Healon5 control using a non-inferiority margin of 10%.|3 months|Results are based on paired-eye subjects included in the safety population, which differs from the total number of participant (paired + non-paired eyes)safety population used in the Participant Flow.|||Participants|||Count of Participants
2553128|NCT02782377|Primary|Hysteresis|"Measurements of differences in Hysteresis (%) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).~Hysteresis is the extent of energy expenditure during opening and closing of the anal canal and represents the difference between opening and closing pressure and is expressed as a percentage"|during single study visit- measurement taken prior to balloon inflation and post balloon inflation||||percent||Full Range|Median
2553129|NCT02782377|Primary|Closing Elastance|Measurements of differences in Closing Elastance (Ce - cm H2O/mm2) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).|during single study visit- measurement taken prior to balloon inflation and post balloon inflation||||cmH2O/mm2||Full Range|Median
2553147|NCT02781844|Primary|Total Urinary Excretion of Calcium Over 24 Hours by Day -1|Total urinary excretion of calcium over 24 Hours by Day -1 was reported.|Day -1|PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||mmol||Standard Deviation|Mean
2553130|NCT02782377|Primary|Closing Pressure|Measurements of differences in Closing Pressure (Cp - cm H2O) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).|during single study visit- measurement taken prior to balloon inflation and post balloon inflation||||cmH2O||Full Range|Median
2553131|NCT02782377|Primary|Opening Elastance|Measurements of differences in Opening Elastance (Oe - cm H2O/mm2) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).|during single study visit- measurement taken prior to balloon inflation and post balloon inflation||||cmH2O/mm2||Full Range|Median
2553132|NCT02782377|Primary|Opening Pressure|"Measurements of differences in Opening pressure (Op - cm H2O) as measured by the AAR catheter.~These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR)."|during single study visit- measurement taken prior to balloon inflation and post balloon inflation||||cmH2O||Full Range|Median
2553133|NCT02782325|Secondary|Number of Patients With Clinical Response i at Week 16 and Active Pouchitis at Baseline|This outcome measure is for patients with active pouchitis symptoms entering the trial. Response as defined by a composite assessment of which both criteria has to be met: Decrease from baseline mPDAI clinical subscore > 2 points and no need for antibiotic therapy at week 16.|16 weeks|None of the patients in the trial entered the study with symptoms of active pouchitis||||||
2553134|NCT02782325|Secondary|Number of Patients With Clinical Response Week 8 and Active Pouchitis at Baseline|Response as defined by a composite assessment of which both criteria has to be met: Decrease from baseline mPDAI clinical subscore > 2 points and no need for antibiotic therapy at week 8 of the randomized phase.|8 weeks|Only 1 patient in the open label FMT completed the week 8 visit, but entered the trial in remission and thus did n to meet the criterion of a decrease of the clinical PDA sub core decrease|||Participants|||Count of Participants
2553135|NCT02782325|Secondary|Number of Patients With Clinical Response at Week 4 in Patients Entering the Trial With Active Pouchitis Symptoms|"This outcome measure is for patients with active pouchitis symptoms entering the trial. Since all patients entered with inactive pouchitis no patient could be evaluated for this outcome.~Response as defined by a composite assessment of which both criteria has to be met: Decrease from baseline mPDAI clinical subscore > 2 points and no need for antibiotic therapy at week 4."|4 weeks|Since all patients entered with inactive pouchitis no patient could be evaluated for this outcome.||||||
2553136|NCT02782325|Secondary|Number of Patients With Endoscopic Improvement Week 4 After Endoscopic and Oral FMT|Endoscopic improvement of active pouchitis (decrease from baseline in modified pouch disease activity index endoscopic subscore > 2 points) at week 4.|4 weeks|None of the patients in the randomized phase underwent an endoscopy at week 4 since they all relapsed before week 4. In the open label extension only 1 patient underwent endoscopy at week 4 and the pouch was endoscopically unchanged.|||Participants|||Count of Participants
2553137|NCT02782325|Secondary|Number of Patients in Clinical Remission Week 16|Clinical remission as defined by a composite assessment, of which all criteria need to be met: Clinical mPDAI score ≤4 points and no need for antibiotic therapy at week 16.|16 weeks||||Participants|||Count of Participants
2553138|NCT02782325|Secondary|Number of Patients in Clinical Remission Week 4 After Endoscopic and Oral FMT|Clinical remission as defined by a composite assessment, of which all criteria need to be met: Clinical modified pouch diseases activity index (mPDAI) score ≤4 points and no need for antibiotic therapy at week 4.|4 weeks||||Participants|||Count of Participants
2553139|NCT02782325|Primary|Number of Patients With FMT Related Adverse Event|Number of patients with FMT related adverse event (classified according to MedDRA; lowest level term) and categorized according to CTCAE Version 4.0. The safety was assessed in the randomized placebo controlled segment of the study over 24 weeks after initial endoscopic FMT weeks and if the patient should enter the open label extension part of the study also for 24 weeks after initial open label FMT. 6 patients participated in the randomized arm and 5 patients in the open label extension arm.|24 weeks||||Participants|||Count of Participants
2553140|NCT02782169|Secondary|Satisfaction With Analgesia|5-point Likert scale (1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied)|Asked at time point of 24 hours||||Participants|||Count of Participants
2553141|NCT02782169|Secondary|Number of Participants Ever Experiencing Different Symptoms During Abortion|A participant was included once if they ever reported a symptom during the 72 hour study period, not reflective of how long the symptom lasted. These were all commonly reported side effects during previous research on medication abortions and commonly reported side effects of pregabalin, so they were not included as adverse events.|Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)||||participants|||Number
2553142|NCT02782169|Secondary|Number of Oxycodone/Acetominophen Tablets (5/325mg) Used|summed number of tablets used by each participant over the 72 hour study period|Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)||||tablets||Inter-Quartile Range|Median
2553143|NCT02782169|Secondary|Number of Ibuprofen 800mg Tablets Used|summed number of tablets used by each participant over the 72 hour study period|Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)||||tablets||Inter-Quartile Range|Median
2553144|NCT02782169|Primary|Maximum Pain Score Over Study Period|reported on an 11-point numerical rating scale (NRS 0-10) where 0 indicates no pain and 10 indicates the most severe pain|Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)||||units on a scale||Standard Deviation|Mean
2553145|NCT02781844|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE's)|An AE that occured during the study was considered a TEAE if it had a start date/time on or after the first dose of investigational product or if it had a start date before the date of the first dose of investigational product, but increased in severity on or after the date/time of the first dose of investigational product. Number of participants with TEAE's were reported.|From signing of informed consent up to follow up (up to Day 182)|Safety analysis set included enrolled participants who received at least 1 dose of rhPTH(1 84).|||Participants|||Count of Participants
2553146|NCT02781844|Primary|Total Urinary Excretion of Calcium Over 24 Hours by Day 1/ Day 2|Total urinary excretion of calcium over 24 hours by Day1/Day 2 was reported.|Day 1- QD: Pre-dose up to 24 hours post dose, Day 2- BID: Pre-dose up to 24 hours post dose|PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||mmol||Standard Deviation|Mean
2553148|NCT02781844|Primary|Total Amount of Urinary Calcium Excretion to Total Relative Amount of Creatinine Over 24 Hours by Day 1/ Day 2|Total amount of urinary calcium excretion to total relative amount of creatinine over 24 hours by Day 1/ Day 2 was reported.|Day 1- QD: Pre-dose up to 24 hours post dose, Day 2- BID: Pre-dose up to 24 hours post dose|PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||millimoles Per millimoles (mmol/mmol)||Standard Deviation|Mean
2553149|NCT02781844|Primary|Total Amount of Urinary Calcium Excretion to Total Relative Amount of Creatinine Over 24 Hours by Day -1|Total amount of urinary calcium excretion to total relative amount of creatinine over 24 hours by Day -1 was reported.|Day -1|PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||mmol/mmol||Standard Deviation|Mean
2553150|NCT02781844|Primary|Maximum Effect (Emax) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2|Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. Emax of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day 1/Day 2 were reported.|Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose|PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||mmol/L||Standard Deviation|Mean
2553151|NCT02781844|Primary|Time to Maximum Effect (TEmax) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2|Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. TEmax of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day 1/Day 2 were reported.|Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose|PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||hours||Full Range|Median
2553152|NCT02781844|Primary|Area Under the Concentration-Time Curve That is Below the Baseline, From Time 0 to 24 Hours (AUCbelow) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2|Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. AUCbelow of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day 1/Day 2 was reported.|Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose|PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||h*mmol/L||Standard Deviation|Mean
2553153|NCT02781844|Primary|Area Under the Concentration-Time Curve That is Above the Baseline, From Time 0 to 24 Hours (AUCabove) of Baseline-Adjusted Serum Calcium Concentrations on Day 1/Day 2|Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. AUCabove of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day 1/Day 2 were reported.|Day1- QD: Pre-dose up to 24 hours post dose, Day2- BID: Pre-dose up to 36 hours post dose|PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||h*mmol/L||Standard Deviation|Mean
2553154|NCT02781844|Primary|Maximum Effect (Emax) of Baseline-Adjusted Serum Calcium Concentrations on Day -1|Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. Emax of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day -1 were reported.|Day -1|PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||millimoles/Liter (mmol/L)||Standard Deviation|Mean
2553155|NCT02781844|Primary|Time to Maximum Effect (TEmax) of Baseline-Adjusted Serum Calcium Concentrations on Day -1|Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. TEmax of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day -1 were reported.|Day -1|PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||hours||Full Range|Median
2553156|NCT02781844|Primary|Area Under the Concentration-Time Curve That is Below the Baseline, From Time 0 to 24 Hours (AUCbelow) of Baseline-Adjusted Serum Calcium Concentrations on Day -1|Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. AUCbelow of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day -1 was reported.|Day -1|PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||h*mmol/L||Standard Deviation|Mean
2553157|NCT02781844|Primary|Area Under the Concentration-Time Curve That is Above the Baseline, From Time 0 to 24 Hours (AUCabove) of Baseline-Adjusted Serum Calcium Concentrations on Day -1|Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. AUCabove of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium [uncorrected]) concentrations on Day -1 was reported. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|Day -1|Pharmacodynamic (PD) analysis set consisted of all enrolled participants who did not have major protocol violations that affected the validity of the PD results, received at least 1 dose of rhPTH(1 84) and had at least 1 evaluable post-dose PD value available for 1 dose regimen.|||hour*millimoles per Liter (h*mmol/L)||Standard Deviation|Mean
2553158|NCT02781844|Primary|Terminal Half-Life (t1/2) of Baseline Adjusted rhPTH(1-84)|Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. T1/2 of baseline adjusted rhPTH(1-84) was reported.|QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose|PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure and at specific category.|||hours||Geometric Coefficient of Variation|Geometric Mean
2553190|NCT02781571|Primary|Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who took at least 1 dose if the study drug.|||percentage of participants|||Number
2553159|NCT02781844|Primary|Area Under the Concentration Curve From Time of the Second Dose to 12 Hours Post the Second Dose (AUC12-24) of Baseline Adjusted rhPTH(1-84)|Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUC12-24 of baseline adjusted rhPTH(1-84) was reported. AUC(12-24) was planned, analyzed and reported only in participants who received BID treatment ( Treatment A, Treatment C, Treatment D, Treatment F).|BID: 12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24 hours post-dose|PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2553160|NCT02781844|Primary|Area Under the Concentration Curve From Time Zero to 12 Hours Post the First Dose (AUC0-12) of Baseline Adjusted rhPTH(1-84)|Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUC0-12 of baseline adjusted rhPTH(1-84) was reported. AUC(0-12) was planned, analyzed and reported only in participants who received BID treatment ( Treatment A, Treatment C, Treatment D, Treatment F).|BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours post-dose|PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2553161|NCT02781844|Primary|Area Under the Concentration Curve From Time Zero to 24 Hours Post the First Dose (AUC0-24) of Baseline Adjusted rhPTH(1-84)|Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUC0-24 of baseline adjusted rhPTH(1-84) was reported.|QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24 hours post-dose|PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2553162|NCT02781844|Primary|Area Under the Curve Extrapolated to Infinity (AUCinf) of Baseline Adjusted rhPTH(1-84)|Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUCinf of baseline adjusted rhPTH(1-84) was reported.|QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose|PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure and at specific category.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2553163|NCT02781844|Primary|Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Baseline Adjusted rhPTH(1-84)|Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUClast of baseline adjsuted plasma rhPTH(1-84) was reported.|QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose|PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure and at specific category.|||hour*picogram per milliliter (h*pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2553164|NCT02781844|Primary|Maximum Plasma Concentration (Cmax) of Baseline Adjusted rhPTH(1-84)|Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. Cmax of baseline adjusted rhPTH(1-84) was reported.|QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose|PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||picogram per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2553165|NCT02781844|Primary|Time of Maximum Observed Concentration (Cmax) During a Dosing Interval (Tmax) of Baseline Adjusted rhPTH(1-84)|Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. Tmax of baseline adjusted rhPTH(1-84) was reported. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose ; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose|Pharmacokinetic (PK) analysis set consisted of all enrolled participants who did not have major protocol violations that affected the validity of the PK results, received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable postdose PK concentration value available for 1 dose regimen.|||hours||Full Range|Median
2553166|NCT02781818|Secondary|Patient Rating of Impression of Treatment at Day 14|"Patients will rate their impression of the treatment for each site as follows:~0. Made it worse;~Not helpful;~A little bit helpful;~Moderately helpful;~Very helpful~Comparison of rating of impression of treatment between the combined treatment groups and placebo will be performed. Similar comparison will be performed between the triamcinolone 10mg/ml and triamcinolone 40mg/ml treatment arms."|14 days||||units on a scale|Lesions|95% Confidence Interval|Mean
2553167|NCT02781818|Secondary|Change in Pain From Baseline to Day 5|Patients will rate pain on a scale of 1-10 (1 being no pain, 10 being the worst possible pain) at the baseline visit and on day 5. A secondary outcome will compare reduction in pain on day 5 in the combined treatment groups compared to the placebo group, and between the two treatment arms.|Baseline, Day 5||||units on a scale|Lesions|95% Confidence Interval|Mean
2553168|NCT02781818|Primary|Number of Days to Lesion Resolution in Combined Treatment Arms Compared to the Placebo Arm.|Mean number of days that patient reports it takes for a lesion to resolve. This is defined as a return of the skin to baseline in the treated area and an absence of pain.|1-14 days||||Days|Lesions|95% Confidence Interval|Mean
2553169|NCT02781649|Secondary|Kidney Function at 12 Months|Serum creatinine mg/dL at 12 months following transplantation|12 months following transplantation|There were no participants who received a kidney from a donor with genotype 1a infection and resistance. Therefore this population is zero.|||mg/dL||Full Range|Median
2553170|NCT02781649|Secondary|Kidney Function at 6 Months|Serum creatinine mg/dL at 6 months following transplantation|6 months following transplantation|There were no participants who received a kidney from a donor with genotype 1a infection and resistance. Therefore this population is zero.|||mg/dL||Full Range|Median
2553171|NCT02781649|Secondary|IP-10 Elevations|Measurement of interferon (IFN)-gamma inducible protein 10 (IP-10) a marker of acute hepatitis C infection.|12 weeks|Data were not collected||||||
2553172|NCT02781649|Secondary|Number of Participants With Nonstructural Protein 5A (NS5A) Resistance Mutations in the HCV Population From the Deceased Donors|"Number of participants with NS5A resistance mutations in the HCV population from the deceased donors.~Number of donors with NS5A resistance mutations"|Baseline|There were no participants who received a kidney from a donor with genotype 1a infection and resistance. Therefore this population is zero.|||Participants|||Count of Participants
2553173|NCT02781649|Secondary|Antibody Development|Number of kidney transplant recipients who become reactive for HCV antibody|12 weeks|There were no participants who received a kidney from a donor with genotype 1a infection and resistance. Therefore this population is zero.|||Participants|||Count of Participants
2553174|NCT02781649|Secondary|Viral Response|This is the number of participants with undetectable hepatitis C RNA in the blood at 12 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA < Lower Limit Of Quantification (LLOQ) at week 12|12 weeks after completing treatment|There were no participants who received a kidney from a donor with genotype 1a infection and resistance. Therefore this population is zero.|||Participants|||Count of Participants
2553175|NCT02781649|Primary|Number of Participants With Grade 3 or Higher Treatment-related Adverse Events as US Department of Health and Human Services Common Terminology of Adverse Events (CTCAE) Version 4|Proportion of participants with grade 3 or higher treatment-related adverse events (AE) as assessed by US Department of Health and Human Services Common Terminology of AEs version 4. An AE is an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5. Grade 3 Severe or medically significant but not life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. The investigator will determine if the AE is related to the treatment.|12 weeks after transplant|There were no participants who received donors found to have hepatitis C genotype 1a with resistance enrolled.|||Participants|||Count of Participants
2553176|NCT02781571|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 12 weeks of treatment)~Virologic relapse:~HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement"|Up to Posttreatment Week 12|Full Analysis Set|||percentage of participants|||Number
2553177|NCT02781571|Secondary|Change From Baseline in HCV RNA at Week 12||Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2553178|NCT02781571|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2553179|NCT02781571|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2553180|NCT02781571|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2553181|NCT02781571|Secondary|HCV RNA at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2553182|NCT02781571|Secondary|HCV RNA at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2553183|NCT02781571|Secondary|HCV RNA at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2553184|NCT02781571|Secondary|HCV RNA at Week 2||Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2553185|NCT02781571|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2553186|NCT02781571|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2553187|NCT02781571|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2553188|NCT02781571|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2553189|NCT02781571|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||Percentage of participants||95% Confidence Interval|Number
2553191|NCT02781571|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: all enrolled participants who took at least 1 dose of the study drug|||percentage of participants||95% Confidence Interval|Number
2553192|NCT02781558|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement"|Up to Posttreatment Week 12|Full Analysis Set|||percentage of participants|||Number
2553193|NCT02781558|Secondary|Change From Baseline in HCV RNA at Week 12||Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2553194|NCT02781558|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2553195|NCT02781558|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2553196|NCT02781558|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2553197|NCT02781558|Secondary|HCV RNA at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2553198|NCT02781558|Secondary|HCV RNA at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2553199|NCT02781558|Secondary|HCV RNA at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2553200|NCT02781558|Secondary|HCV RNA at Week 2||Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2553201|NCT02781558|Secondary|Percentage of Participants Who Have HCV RNA < LLOQ at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2553202|NCT02781558|Secondary|Percentage of Participants Who Have HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2553203|NCT02781558|Secondary|Percentage of Participants Who Have HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2553204|NCT02781558|Secondary|Percentage of Participants Who Have HCV RNA < LLOQ at Week 2||Week 2|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2553205|NCT02781558|Secondary|Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4)|SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2553206|NCT02781558|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug (Which Included SOF/VEL and RBV) Due to Any Adverse Event||Posttreatment Week 12|Safety Analysis Set|||percentage of participants|||Number
2553207|NCT02781558|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: all randomized participants who took at least 1 dose of any study drug|||percentage of participants||95% Confidence Interval|Number
2553208|NCT02781454|Other Pre-specified|Change in Slow Vital Capacity|Measure of decline in respiratory muscle strength|Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported||||maximum percent predicted||95% Confidence Interval|Least Squares Mean
2553209|NCT02781454|Other Pre-specified|Change in the Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised|The Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) is an instrument for evaluating the functional status of patients with ALS that includes functions related to speech, swallowing, salivation, fine motor control, gross motor function, and respiration. The score is the sum of 12 items (range 0 to 48) with higher scores reflecting better function.|Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported||||score on a scale||95% Confidence Interval|Least Squares Mean
2553210|NCT02781454|Secondary|Effect on Frequency of Fasciculations (Muscle Twitching)|Will be assessed using a daily fasciculations diary tabulated as a percentage of days from weeks 3-4.|Accessed at Screening, Baseline, Week 4, and Week 8; comparisons of treatments at Weeks 3-4 reported||||percentage of days with fasciculations||Inter-Quartile Range|Median
2553211|NCT02781454|Secondary|Effect on Frequency of Muscle Cramps|Will be assessed using a daily muscle cramps diary tabulated weekly beginning at Baseline.|Accessed at Screening, Baseline, Week 4, and Week 8; comparisons of treatments at Weeks 3-4 reported||||muscle cramps/week||95% Confidence Interval|Geometric Least Squares Mean
2553212|NCT02781454|Secondary|Effect on Subexcitability|Subexcitability is a component of recovery cycle analysis assessing motor axonal excitability, employing threshold tracking nerve conduction study. It is a late hyperpolarizing after potential measured following a single supramaximal stimulus followed by a second smaller stimulus of variable intensity and is related to the very slow turn-off of slow potassium channels.|Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported||||percentage of threshold change||95% Confidence Interval|Least Squares Mean
2553261|NCT02780622|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 24 Hours (AUC0-24h) for Oseltamivir and Oseltamivir Carboxylate||Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 18 and 24 hours post-dose on Day 5|All enrolled participants.|||h*ng/mL||Standard Deviation|Mean
2553213|NCT02781454|Secondary|Effect on Superexcitability|Superexcitability is a component of recovery cycle analysis assessing motor axonal excitability, employing threshold tracking nerve conduction study. It is a depolarizing afterpotential measured following a single supramaximal stimulus followed by a second smaller stimulus of variable intensity and reflects passive depolarization of the internodal axon.|Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported||||percentage of threshold change||95% Confidence Interval|Least Squares Mean
2553214|NCT02781454|Secondary|Effect on Hyperpolarizing Threshold Electrotonus (90-100 ms)|Hyperpolarizing threshold electrotonus (90-100 ms) (TEh 90-100 ms) is used in threshold tracking nerve axonal excitability studies in which long-lasting subthreshold hyperpolarizing currents are generated, measured at 90-100 ms following the stimulus. This measure is associated with an increase in the membrane excitability threshold due to closure of potassium channels causing increased resistance of the internodal axonal membrane. Intrinsic changes in axonal excitability properties, such as thought to occur in ALS, could possibly alter this measure.|Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported||||percentage threshold hyperpolarization||95% Confidence Interval|Least Squares Mean
2553215|NCT02781454|Secondary|Effect on Depolarizing Threshold Electrotonus (90-100 ms)|Depolarizing threshold electrotonus (90-100 ms) (TEd 90-100 ms) is used in threshold tracking nerve axonal excitability studies in which long-lasting subthreshold depolarizing currents are generated, measured at 90-100 ms following the stimulus. This measure is associated with a decrease in the membrane excitability threshold due to opening of potassium channels on the axonal membrane. Intrinsic changes in axonal excitability properties, such as thought to occur in ALS, could possibly alter this measure, presumably by decreasing TEd 90-100 ms more substantially than normal.|Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported||||percentage of threshold depolarization||95% Confidence Interval|Least Squares Mean
2553216|NCT02781454|Secondary|Effect on Strength Duration Time Constant|The strength duration time constant (SDTC) is used in threshold tracking nerve axonal excitability studies and is interpreted as a measure of axonal excitability that is dependent upon the biophysical properties of the axonal membrane at the node of Ranvier, especially persistent sodium current. It is derived from the relationship between stimulus duration and intensity. A higher SDTC would reflect greater excitability of motor nerve axons.|Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported|strength duration time constant|||milliseconds||95% Confidence Interval|Geometric Least Squares Mean
2553217|NCT02781454|Secondary|Effect on Cortical Silent Period|The cortical silent period (CSP) is recorded with single pulse TMS as a duration from the onset of the MEP response to resumption of voluntary electromyography activity with the patient performing a voluntary contraction, set to 30% of maximal voluntary contraction. A shorter CSP compared to controls would reflect greater excitability.|Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported||||milliseconds||95% Confidence Interval|Least Squares Mean
2553218|NCT02781454|Secondary|Change in Motor Evoked Potential Amplitude|The motor evoked potential (MEP) amplitude is taken from single pulse transcranial magnetic stimulation (TMS) and reflects the density of corticomotoneuronal projections onto motor neurons and is affected by cortical hyperexcitability early in ALS where it is thought to be larger than age-matched controls and axonal degeneration later in the disease when it decreases in amplitude. The MEP is most reliable in assessing cortical motor neuronal preservation and excitability when normalized to the peak compound nerve action potential (CMAP) amplitude which reflects the integrity of peripheral motor nerve axons. It is also normalized here to 120% of the RMT to derive a ratio of MEP at 120% RMT/peak CMAP.|Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported|MEP at 120% RMT/peak CMAP|||unitless ratio of ms/ms||95% Confidence Interval|Geometric Least Squares Mean
2553219|NCT02781454|Secondary|Effect on Short-interval Intracortical Inhibition|Short-interval intracortical inhibition (SICI) is a measure of neuronal excitability measured by dual pulse TMS with a conditioned (80% of RMT) and test pulses (120% of RMT) to generate a stable MEP amplitude of 0.2 mV, averaged over interstimulus intervals of 1-7 ms. It is thought to reflect refractory cortical axons and subsequent resynchronization of cortico-cortical and corticomotoneuronal volleys or activation of non-GABAergic cortical inhibitory circuits (initial phase) and synaptic neurotransmission through GABAA receptors (second phase). The value for SICI thought to be maximally sensitive for detecting in changes in ALS subjects compared to controls is is derived by measuring the motor evoked potential amplitude (MEP) at an interstimulus interval of 3 ms (ISI 3 ms) and normalizing to the MEP amplitude at 120% of the resting motor threshold (MEP 120% RMT). A reduction in SICI reflecting greater excitability would generate a larger ratio of MEP ISI 3 ms/MEP 120% RMT.|Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 reported||||unitless ratio MEP ISI 3 ms/MEP 120% RMT||95% Confidence Interval|Geometric Least Squares Mean
2553220|NCT02781454|Primary|Change in Resting Motor Threshold|The resting motor threshold (RMT) assessed from single pulse transcranial magnetic stimulation (TMS) measurements made before treatment, after 4 weeks of treatment, and then again after a 4 week washout, was used as the primary pharmacodynamic marker of cortical hyperexcitability. RMT is the stimulus intensity required to produce and maintain a 0.2 mV peak-to-peak motor evoked potential of the abductor pollicis brevis muscle by TMS. A smaller RMT is thought to suggest greater neuronal excitability.|Accessed at Screening, Baseline, Week 4, and Week 8; change from Baseline to Week 4 and from Week 4 to Week 8 reported||||percentage of maximum stimulus output||Standard Error|Least Squares Mean
2553221|NCT02781324|Other Pre-specified|Intraoperative Use of Antifibrinolytic||Intraoperative||||Participants|||Count of Participants
2553222|NCT02781324|Other Pre-specified|Postoperative Hematocrit||Short Term Postoperative (12-18 hours after procedure)|deviation in numbers due to some postop labs not being drawn and therefore no postop hematocrit values were collected|||grams/deciliter||Standard Deviation|Mean
2553223|NCT02781324|Other Pre-specified|Preoperative Hematocrit||Preoperative (prior to first incision)|one less standard of care participant analyzed because labs were not drawn in designated window.|||grams/deciliter||Standard Deviation|Mean
2553262|NCT02780622|Secondary|Maximum Plasma Concentration (Cmax) for R- and S- Warfarin|R- and S-warfarin are two molecular versions of warfarin with slightly different structures. The reported concentrations were normalized by dividing the Cmax values (nanograms per milliliter) by the individual average dose (milligrams).|Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.|||Nanogram/milliliter/milligram (ng/mL/mg)||Standard Deviation|Mean
2553224|NCT02781324|Other Pre-specified|Percent of Participants With Lenke 1 Curve Pattern|Lenke Type 1 is a main thoracic curve pattern, and is the most common pattern observed in cases of adolescent idiopathic scoliosis (AIS). The Lenke Classification System provides surgeons with a simple, accurate, and reproducible way to communicate about scoliosis. It relies on measurements taken from standard x-rays. The surgeon evaluates the x-ray from the front, side, and in bending positions. Each scoliosis curve is then classified in three ways: by the curve type based on the three regions of the spine, a lumbar spine modifier, and a sagittal thoracic modifier. The classification system combines the curve type (1-6) with the lumbar modifier (A, B, C) and the sagittal thoracic modifier (-. N, +) to form the complete classification.|Preoperative (up to 1 month before scheduled date of surgery)||||percentage of participants|||Number
2553225|NCT02781324|Other Pre-specified|Weight (kg) at Surgery||Preoperative (on day of surgery)||||kilograms||Standard Deviation|Mean
2553226|NCT02781324|Other Pre-specified|BMI Percentile at Surgery||Preoperative (on day of surgery)||||percentile||Standard Deviation|Mean
2553227|NCT02781324|Other Pre-specified|Number of Vertebral Levels Fused||Intraoperative||||vertebral levels||Standard Deviation|Mean
2553228|NCT02781324|Other Pre-specified|Postoperative Major Cobb Angle (Degrees)|Cobb angle is a measurement of the degree of side-to-side spinal curvature used to define Scoliosis. A Cobb angle of 10 degrees is the minimum angle to define scoliosis. Angles of 40-50 degrees or more may require corrective surgery. Cobb angle will be measured from postoperative radiographs|Short Term Postoperative (3 month), Long Term Postoperative (1 year)||2020-01-31|01/2020||||
2553229|NCT02781324|Other Pre-specified|Preoperative Major Cobb Angle (Degrees)|measured from preoperative radiographs|Preoperative (up to 1 month before scheduled date of surgery)||||degrees||Standard Deviation|Mean
2553230|NCT02781324|Secondary|Procedure Time (Minutes)||Intraoperative (for duration of the procedure)||||minutes||Standard Deviation|Mean
2553231|NCT02781324|Secondary|Number of Patients With Intraoperative and Postoperative Blood Transfusions in the Ultrasonic Bone Scalpel Group and Standard of Care Group|This outcome measure measures the number of patients with intraoperative and postoperative blood transfusions placed in the Ultrasonic Bone Scalpel Group and the Standard of Care Group.|Intraoperative, Short Term Postoperative (end of procedure until hospital discharge, up to 7 days after surgery)||||Participants|||Count of Participants
2553232|NCT02781324|Primary|Estimated Blood Loss/Level|Estimated blood loss is being obtained from the report generated by the cell saver.|Intraoperative|The above 65 patients were analyzed as part of a treated cohort and an intention-to-treat cohort. The discrepancy between the 65 patients with data evaluated and the 66 patients initially consented is explained by 1 patient who withdrew consent from the study. The study team therefore did not feel it was ethical to collect this patient's data.|||mL||Standard Deviation|Mean
2553233|NCT02781311|Primary|Subject Self-Assessment (SSA) Score in Hair Growth at Week 24|The SSA consisted of a single-item measure that assesses each participant's perception of change in scalp hair growth. The participant used a standardized global photograph of his scalp taken at the Screening visit presented side by side with a standardized global photograph taken at the postbaseline visit to give a comparative score. The photographs were presented in a blinded and randomized manner to avoid influencing the participant, and response options were on a 7-point ordinal scale (where, ‐3=Greatly decreased, ‐2=Moderately decreased, ‐1=Slightly decreased, 0=No change, +1=Slightly increased, +2=Moderately increased and +3=Greatly increased). The higher the mean SSA value, the more the perception of hair growth from baseline. Missing data are imputed up to Week 24 using LOCF method.|Week 24|mITT population included all randomized participants who received study intervention and had a baseline and at least 1 postbaseline measurement for 1 of the coprimary efficacy measures. As per protocol Amendment 1, Finasteride arm group was not included in the analysis model. Number analyzed is participants with data available for analysis.|||score on a scale||Standard Error|Least Squares Mean
2553234|NCT02781311|Primary|Change From Baseline in Target Area Hair Count (TAHC) at Week 24|TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters square (cm^2). TAHC is a standardized objective quantification of the number of hairs within a prespecified target area of the scalp at different timepoints, using macrophotography digital images. The total number of terminal hairs (hair width ≥ 30 μm) was calculated from macrophotographs. The target area used to count TAHC was a 1 cm^2 circular area of clipped hair (length approximately 1 mm) located at the anterior leading edge of the vertex thinning area of the scalp and centered with a semi-permanent microdot tattoo to ensure the same target area was reproduced at each visit. A positive change from Baseline indicated improvement (increase in the number of terminal hairs). Missing data are imputed up to Week 24 using last observation carried forward (LOCF) method.|Baseline (Day 1) to Week 24|mITT population included all randomized participants who received study intervention and had a baseline and at least 1 postbaseline measurement for 1 of the coprimary efficacy measures. As per protocol Amendment 1, Finasteride arm group was not included in the analysis model. Number analyzed is participants with data available for analysis.|||terminal hairs/cm^2||Standard Error|Least Squares Mean
2553235|NCT02781051|Secondary|Depressive Symptoms Measured by the Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR)|"Assess changes in depressive symptoms at 6 months following physical activity intervention.~Title: Quick Inventory of Depressive Symptomatology - Self Report(QIDS-SR) Scoring: ranges from 0-27, higher scores indicate more severe symptomatology"|6 months|14 participants provided follow-up data|||units on a scale||Standard Deviation|Mean
2553236|NCT02781051|Primary|Moderate-to-vigorous Physical Activity Measured by Actigraph Accelerometer|Assess changes in physical activity at 6 months following physical activity intervention.|6 months|12 participants provided valid baseline and follow-up data.|||minutes per week||Standard Deviation|Mean
2553237|NCT02780869|Secondary|Proportion of Subjects Achieving Hemostasis|The proportion of subjects achieving hemostasis at 3 minutes post-hemostat application was calculated|Intraoperative, 3 Minutes Post-Application|The efficacy analysis population was defined as the Time-To-Hemostasis (TTH) population and included all subjects who were randomized, received study intervention, and had a TTH assessment recorded.|||Participants|||Count of Participants
2553238|NCT02780869|Secondary|Product Preparation Time|The average time from the opening of the package to the product being ready to use, measured in minutes and seconds.|Intraoperative|The efficacy analysis population was defined as the Time-To-Hemostasis (TTH) population and included all subjects who were randomized, received study intervention, and had a TTH assessment recorded.|||Minutes||Standard Deviation|Mean
2553239|NCT02780869|Primary|Proportion of Subjects Achieving Hemostasis|The proportion of subjects achieving hemostasis at 6 minutes post-hemostat application was calculated. Hemostasis was defined as a grade of 0 (None/Dry) on the Surface Bleeding Severity Scale, with additional grades, ranging from 1 (Minimal/Oozing) to 5 (Extreme/Gushing), considered a failure of hemostasis.|Intraoperative, 6 Minutes Post-Application|The efficacy analysis population was defined as the Time-To-Hemostasis (TTH) population and included all subjects who were randomized, received study intervention, and had a TTH assessment recorded.|||Participants|||Count of Participants
2553240|NCT02780856|Secondary|User Experience|Completion of User Questionnaires after imaging with the Calcivis system|Day 0|User Questionnaires were completed by the dentist and nurse at the end of every imaging session about their experiences using the Calcivis System. Imaging sessions could include one or several participants, therefore multiple participants could be accounted for in a single User Questionnaire providing 61 questionnaires covering 110 participants.|||User Questionnaires|User Questionnaires||Count of Units
2553241|NCT02780856|Secondary|Patient Experience|Completion of Patient Questionnaires after imaging with the Calcivis System|Day 0|Patient Questionnaires were completed for all 110 patients imaged at Visit 1 and comprised two questions and the patient was asked to tick the most appropriate response on a three-point scale e.g. good, neither good nor bad, bad etc|||patient questionnaires|patient questionnaires||Count of Units
2553242|NCT02780856|Primary|Number of Non-patient Related Adverse Events of the Calcivis System|Collection of all Adverse Events throughout the duration of the study|Day 0 and Day 7|All patients on whom the Calcivis System has been used|||adverse events|||Number
2553243|NCT02780856|Primary|Number of Teeth Identified as Sound or Unsound by the Calcivis System That Were in Agreement With the Dentist's Assessment|Agreement between the dentist's assessment (ICDAS staging) of sound (inactive) and unsound (active) teeth and the visible presence of elevated bioluminescence on the tooth surface using the Calcivis System|Day 0|From the 110 patients recruited and imaged with the Calcivis System, 90 provided a sound tooth (ICDAS 0) and 86 provided an unsound tooth (ICDAS 2 or 3) with interpretable images were included in the Primary Agreement Analysis|||teeth|teeth||Count of Units
2553244|NCT02780765|Primary|Assess the Increase in Nurses Work Load|Investigators will assess nursing workload by frequency of filling of humidifier chamber.|At baseline just before intubation and 24 hours from time of ICU admission|The bevel end & Murphy's eye of the Endotracheal tube was sealed using sterile insulating tape so that it becomes water tight. The tube was gradually filled with measured amount of sterile fluid using small volume syringe to increase the accuracy of measurement. The amount of fluid it can hold was measured & noted|||time of refilling of nebuliser chamber||Standard Deviation|Mean
2553245|NCT02780765|Primary|Extent of Blockade of Endotracheal Tube Assessed by Change in the Endotracheal Tube Volume|The bevel end & Murphy's eye of the Endotracheal tube was sealed using sterile insulating tape so that it becomes water tight. The tube was gradually filled with measured amount of sterile fluid using small volume syringe to increase the accuracy of measurement. The amount of fluid it can hold was measured & noted|At baseline just before intubation and 24 hours from time of ICU admission||||percentage change of ET tube volume||Standard Deviation|Mean
2553246|NCT02780700|Secondary|Percentage of Patients With Grade 3 or Worse Adverse Events|Percentage of patients with grade 3 or worse adverse events.|Data collected up to cut-off date 09 Sep 2016, Up to 02 months|RS|||Percentage of participants|||Number
2553247|NCT02780700|Secondary|Disease Control (DC)|"Disease control is defined as CR or PR or Stable disease (SD) per RECIST version 1.1.~Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out."|Data collected up to cut-off date 09 Sep 2016, Up to 02 months|RS|||Percentage of participants|||Number
2553248|NCT02780700|Secondary|Objective Response Rate (ORR)|"ORR is defined as complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.~Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out."|tumor response was to be assessed by imaging according to RECIST (version 1.1) every 6 weeks.|RS|||Percentage of participants|||Number
2553249|NCT02780700|Secondary|Overall Survival (OS)|"Overall survival is defined as the time from randomization until death from any cause.~Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out."|Data collected up to cut-off date 09 Sep 2016, Up to 02 months|RS|||months||Full Range|Median
2553250|NCT02780700|Primary|Progression Free Survival (PFS)|"PFS is defined as the time from randomization until objective tumor progression or death.~Since only one patient was enrolled prior to termination of the trial, no data summarization or analysis was carried out."|Data collected up to cut-off date 09 Sep 2016, Up to 02 months|Randomized set (RS): Comprising all patients who have a randomization date recorded in the electronic Case record form (eCRF).|||months||Full Range|Median
2553251|NCT02780661|Secondary|Change From Baseline in Candidal Microbial Count on Day 3|Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10 mm filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated aerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 3.|Baseline (Day 0 pre-treatment), Day 3 (post-treatment)|ITT Population defined as all participants who are randomized, received at least one dose of study treatment and have at least one post-baseline assessment of microbial count from disc sampling.|||log10(CFU/disc+1)||Standard Deviation|Mean
2553260|NCT02780622|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 24 Hours (AUC0-24h) for R- and S- Warfarin|R- and S-warfarin are two molecular versions of warfarin with slightly different structures. The reported concentrations were normalized by dividing the AUC values (hours multiplied by nanograms, per milliliter) by the individual average dose (milligrams).|Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.|||h*ng/mL/mg||Standard Deviation|Mean
2560615|NCT02662569|Secondary|Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2553252|NCT02780661|Secondary|Change From Baseline in Anaerobic Bacteria Microbial Count on Day 3|Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10 mm filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated anaerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 3.|Baseline (Day 0 pre-treatment), Day 3 (post-treatment)|ITT Population defined as all participants who are randomized, received at least one dose of study treatment and have at least one post-baseline assessment of microbial count from disc sampling.|||log10(CFU/disc+1)||Standard Deviation|Mean
2553253|NCT02780661|Secondary|Change From Baseline in Aerobic Bacteria Microbial Count on Day 3|Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10 mm filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated aerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 3.|Baseline (Day 0 pre-treatment), Day 3 (post-treatment)|ITT Population defined as all participants who are randomized, received at least one dose of study treatment and have at least one post-baseline assessment of microbial count from disc sampling.|||log10(CFU/disc+1)||Standard Deviation|Mean
2553254|NCT02780661|Primary|Change From Baseline in Candidal Microbial Count on Day 7|Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10 mm filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated aerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 7.|Baseline (Day 0 pre-treatment), Day 7 (post-treatment)|ITT Population defined as all participants who are randomized, received at least one dose of study treatment and have at least one post-baseline assessment of microbial count from disc sampling.|||log10(CFU/disc+1)||Standard Deviation|Mean
2553255|NCT02780661|Primary|Change From Baseline in Anaerobic Bacteria Microbial Count on Day 7|Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10 mm filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated anaerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 7.|Baseline (Day 0 pre-treatment), Day 7 (post-treatment)|ITT Population defined as all participants who are randomized, received at least one dose of study treatment and have at least one post-baseline assessment of microbial count from disc sampling.|||log10(CFU/disc+1)||Standard Deviation|Mean
2553256|NCT02780661|Primary|Change From Baseline in Aerobic Bacteria Microbial Count on Day 7|Microbial count samples were collected using a paper disc (disc sampling). A pre-sterilised 10-millimeter (mm) filter paper disc was lightly pressed against the selected quadrant of maxillary denture, leaving enough space to place two discs without overlap. The selected areas were lateral to the midline and corresponding to the palatal rugae. Microbiological sampling was carried out from one standardised site on the fitting surface of the denture for standard culture. The discs were left for 20 secs prior to aseptic removal using sterile tweezers, and were serially diluted and plated into appropriate agar plates and incubated aerobically. Pre-treatment samples were taken from the left rough and left smooth denture surface. Post-treatment samples were taken from the right rough and right smooth denture surface at Day 7.|Baseline (Day 0 pre-treatment), Day 7 (post-treatment)|Analysis for this outcome was performed on intent-to-treat (ITT) population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of microbial count from disc sampling.|||log10(CFU[colony forming unit]/disc+1)||Standard Deviation|Mean
2553257|NCT02780622|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to Day 26|All enrolled participants.|||percentage of participants|||Number
2553258|NCT02780622|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 12 Hours (AUC0-12h) for R- and S- Warfarin|R- and S-warfarin are two molecular versions of warfarin with slightly different structures. The reported concentrations were normalized by dividing the AUC values (hours multiplied by nanograms, per milliliter) by the individual average dose (milligrams).|Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.|||h*ng/mL/mg||Standard Deviation|Mean
2553259|NCT02780622|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to 12 Hours (AUC0-12h) for Oseltamivir and Oseltamivir Carboxylate||Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.|||h*ng/mL||Standard Deviation|Mean
2553263|NCT02780622|Secondary|Maximum Plasma Concentration (Cmax) for Oseltamivir and Oseltamivir Carboxylate||Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2553267|NCT02780622|Secondary|Terminal Half-life (t½) for Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is an active metabolite of oseltamivir.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.|||hours||Standard Deviation|Mean
2553268|NCT02780622|Secondary|Time to Maximum Plasma Concentration (Tmax) for R- and S- Warfarin||Pre-dose; 1, 2, 4, 8, 12, 24 hours post-dose on Day 5|All enrolled participants.|||hours||Full Range|Median
2553269|NCT02780622|Secondary|Time to Maximum Plasma Concentration (Tmax) for Oseltamivir and Oseltamivir Carboxylate|Oseltamivir carboxylate is an active metabolite of oseltamivir.|Pre-dose; 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post-dose on Day 1 and 5; 18 and 24 hours post-dose on Day 5|All enrolled participants.|||hours||Full Range|Median
2553270|NCT02780622|Primary|Change From Baseline in Plasma Concentration of Vitamin K1|Vitamin K1 is required by proteins involved in blood clotting. Food interaction with warfarin can lead to decreases in Vitamin K1 in plasma. An increase in vitamin K1 signifies enhancement of warfarin's anticoagulant effect.|Pre-dose on Day 1 and 24 hours post-dose on Day 5|All enrolled participants.|||nanogram per liter (ng/L)||Full Range|Mean
2553271|NCT02780622|Primary|Time to Reach Maximum Change From Baseline in Factor VII Activity (Tmax)|Factor VIIa is a protein that causes blood to clot. A decrease in factor VIIa activity signifies enhancement of warfarin's anticoagulant effect.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants with available data.|||hours||Full Range|Median
2553272|NCT02780622|Primary|Change From Baseline in Maximum Observed Effect (Emax) in Factor VII Activity|Factor VIIa is a protein that causes blood to clot. A decrease in factor VIIa activity signifies enhancement of warfarin's anticoagulant effect. kIU/L = 1000 * international units per liter.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants with available data.|||kIU/L||Full Range|Mean
2553273|NCT02780622|Primary|Area Under the Plasma Effect-time Curve Over 96 Hours (AUEC[0-96 h]) for Factor VII Activity|Factor VIIa is a protein that causes blood to clot, and low levels in the blood can cause excessive or prolonged bleeding after an injury or surgery. The net AUEC(0-96 h) was calculated using the linear trapezoidal rule; this was the area under the effect-time curve and above the baseline minus the area above the curve and below the baseline during the 5-day period. A decrease in factor VIIa activity signifies enhancement of warfarin's anticoagulant effect. kIU/L = 1000 * international units per liter.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants with available data.|||hours*kIU/L||Full Range|Mean
2553274|NCT02780622|Primary|Time to Reach Maximum Change From Baseline in International Normalized Ratio (INR) (Tmax)|INR is calculated based on results of a prothrombin time (PT) test (which measures how long it takes blood to clot) and is used to monitor individuals who are being treated with the blood-thinning medication (anticoagulant) warfarin. An increase in INR signifies enhancement of warfarin's anticoagulant effect.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants.|||hours||Full Range|Median
2553275|NCT02780622|Primary|Change From Baseline in Maximum Observed Effect (Emax) of International Normalized Ratio (INR)|INR is calculated based on results of a prothrombin time (PT) test (which measures how long it takes blood to clot) and is used to monitor individuals who are being treated with the blood-thinning medication (anticoagulant) warfarin. An increase in INR signifies enhancement of warfarin's anticoagulant effect.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants.|||ratio||Full Range|Mean
2553276|NCT02780622|Primary|Area Under the Plasma Effect-time Curve Over 96 Hours (AUEC[0-96 h]) for International Normalized Ratio (INR)|INR is calculated based on results of a prothrombin time (PT) test (which measures how long it takes blood to clot) and is used to monitor individuals who are being treated with the blood-thinning medication (anticoagulant) warfarin. The net AUEC(0-96 h) was calculated using the linear trapezoidal rule; this was the area under the effect-time curve and above the baseline minus the area above the curve and below the baseline during the 5-day period. An increase in INR signifies enhancement of warfarin's anticoagulant effect.|Pre-dose on Day 1, 24 hours (Day 2), 48 hours (Day 3), 72 hours (Day 4), and 96 hours (Day 5)|All enrolled participants.|||hours*ratio||Full Range|Mean
2553277|NCT02780388|Secondary|Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to VIB4920|The number of participants with positive antibodies to VIB4920 are reported.|Pre-dose on Days 1, 29, 57, and 85; and on Days 141, and 169|Intent-to treat population included all randomized and treated participants, grouped according to assigned treatment. Participants with available ADA sample were analyzed.|||Participants|||Count of Participants
2553278|NCT02780388|Secondary|Accumulation Ratio (AR) of VIB4920|Accumulation ratio of VIB4920 is reported. Accumulation ratio was determined using AUCtau, Dose 7/AUCtau, Dose 1.|Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169|Pharmacokinetics (PK) population included all treated participants with at least one PK sample with detectable VIB4920. Participants with available PK sample at specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2553279|NCT02780388|Secondary|Volume of Distribution at Steady State (Vss) of VIB4920|Volume of distribution at steady state (Vss) of VIB4920 is reported.|Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169|Pharmacokinetics (PK) population included all treated participants with at least one PK sample with detectable VIB4920. Participants with available PK sample at specified time points were analyzed.|||mL||Standard Deviation|Mean
2553280|NCT02780388|Secondary|Terminal Elimination Half-life (t½) of VIB4920|Terminal elimination half-life (t½) is the time required for half of the drug to be eliminated from the plasma.|Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169|Pharmacokinetics (PK) population included all treated participants with at least one PK sample with detectable VIB4920. Participants with available PK sample at specified time points were analyzed.|||Days||Standard Deviation|Mean
2553529|NCT02774681|Other Pre-specified|Cyclin D1 Aberrations Assessed by Circulating Tumor DNA|Analyze circulating tumor DNA to assess cyclin D1 aberrations and if this is predictive of response to treatment. Circulating tumor DNA will be collected from whole blood at baseline, 2 and 4 months through commercial next generation sequencing assays.|At baseline, 2 months and 4 months|||||||
2553281|NCT02780388|Secondary|Systemic Clearance (CL) of VIB4920|Systemic clearance is a quantitative measure of the rate at which a drug substance is removed from the body.|Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169|Pharmacokinetics (PK) population included all treated participants with at least one PK sample with detectable VIB4920. Participants with available PK sample at specified time points were analyzed.|||mL/day||Standard Deviation|Mean
2553282|NCT02780388|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of VIB4920|Area under the plasma concentration time curve from time zero to extrapolated infinite time (AUC0-inf) of VIB4920 is reported.|Post-dose (end of infusion) on Day 1, pre-dose on Day 15; pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169|Pharmacokinetics (PK) population included all treated participants with at least one PK sample with detectable VIB4920. Participants with available PK sample at specified time points were analyzed.|||µg*day/mL||Standard Deviation|Mean
2553283|NCT02780388|Secondary|Dose Normalized AUCtau of VIB4920|Dose normalized AUCtau of VIB4920 is reported. Dose normalized AUCtau is calculated by dividing AUCtau by the dose of administered VIB4920 (in mg).|Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169|Pharmacokinetics (PK) population included all treated participants with at least one PK sample with detectable VIB4920. Participants with available PK sample at specified time points were analysed.|||µg*day/mL/mg||Standard Deviation|Mean
2553284|NCT02780388|Secondary|Area Under the Plasma Concentration Time Curve of the Dosing Interval (AUCtau) of VIB4920|Area under the plasma concentration time curve of the dosing interval (AUCtau) of VIB4920 is reported.|Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169|Pharmacokinetics (PK) population included all treated participants with at least one PK sample with detectable VIB4920. Participants with available PK sample at specified time points were analyzed.|||µg*day/mL||Standard Deviation|Mean
2553285|NCT02780388|Secondary|Time to Maximum Plasma Concentration (Tmax) of VIB4920|Time to maximum plasma concentration (Tmax) of VIB4920 is reported.|Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169|Pharmacokinetics (PK) population included all treated participants with at least one PK sample with detectable VIB4920. Participants with available PK sample at specified time points were analyzed.|||Days||Full Range|Median
2553286|NCT02780388|Secondary|Maximum Observed Plasma Concentration (Cmax) of VIB4920|Maximum observed plasma concentration (Cmax) of VIB4920 is reported.|Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169|Pharmacokinetics (PK) population included all treated participants with at least one PK sample with detectable VIB4920. Participants with available PK sample at specified time points were analyzed.|||µg/mL||Standard Deviation|Mean
2553287|NCT02780388|Primary|Number of Participants With Treatment-emergent AEs of Special Interests (AESIs)|An AESI (serious or non-serious) is one of scientific and medical interest specific to understanding of study drug and may have required close monitoring, collection of additional information by investigator and rapid communication by investigator to the sponsor.|Day 1 through Day 169|As-treated population included all treated participants, grouped according to actual treatment received.|||Participants|||Count of Participants
2553288|NCT02780388|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.|Day 1 through Day 169|As-treated population included all treated participants, grouped according to actual treatment received.|||Participants|||Count of Participants
2553289|NCT02780349|Primary|Freedom From Major Adverse Events (MAE) to 30 Days Post Procedure.|MAE defined as a serious adverse event that results in death, acute myocardial infarction, thrombosis, pseudo-aneurysm, dissection (grade C or greater) or clinical perforation at the filter location, distal embolism (clinically relevant), unplanned amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC)|30 days||||Participants|||Count of Participants
2553290|NCT02780167|Secondary|Change From Baseline in the Hospital and Anxiety Depression Scale (HADS) at All Scheduled Time Points|The HADS is a 14-item PRO measure used to detect states of anxiety and depression over the past week. The HADS was completed as per schedule of activities. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||units on a scale||Standard Deviation|Mean
2553291|NCT02780167|Secondary|Change From Baseline in Patient Oriented Eczema Measure (POEM) at All Scheduled Time Points|"The POEM is a 7-item patient reported outcome (PRO) measure used to assess the impact of AD over the past week. Each item is scored as no days (0), 1-2 days (1), 3-4 days (2), 5-6 days (3) and every day (4). The score ranges from 0 to 28. The higher values represent more severe AD."|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||units on a scale||Standard Deviation|Mean
2553530|NCT02774681|Other Pre-specified|Change in Quality of Life in Patients Receiving Palbociclib|Quality of life measures will be assessed at baseline, 2 months and 4 and will be collected using patient reported outcome questionnaires: Functional Assessment of Cancer Therapy-Brain (FACT-Br) Version 4.0|At baseline, 2 months and 4 months|||||||
2553292|NCT02780167|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at All Scheduled Time Points|"The DLQI is a general dermatology questionnaire that consists of 10 items that assess participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). It has been extensively used in clinical trials for AD. The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 2-5 point change from baseline. Each item is scored as very much (3), a lot (2), a little (1) and not at all (0). The score can range from 0 to 30. The higher values represent the worse dermatology life quality."|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||units on a scale||Standard Deviation|Mean
2553293|NCT02780167|Secondary|Percentage of Participants With Patient Global Assessment (PtGA) of AD of Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points|"The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the Physician's Global Assessment was used for the PtGA, ie, severe (4), moderate (3), mild (2),almost clear (1), and clear (0). The PtGA was completed as per schedule of activities."|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
2553294|NCT02780167|Secondary|Number of Participants With Specific Clinical Laboratory Abnormalities (Anemia, Neutropenia, Thrombocytopenia, Lymphopenia, Lipid Profile, Liver Function Tests (LFTs)||Baseline up to Week 16|Safety Analysis Set: All participants who received at least 1 dose of study treatment.|||participants|||Number
2553295|NCT02780167|Secondary|Number of Participants With Treatment-emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Treatment-emergent AEs were events that occurred between the first dose of study drug and the subject's last visit (Week 16) that were absent before treatment or that worsened relative to pretreatment state.|Baseline till Week 16|Safety Analysis Set: All participants who received at least 1 dose of study treatment.|||participants|||Number
2553296|NCT02780167|Secondary|Percentage of Participants Achieving a >=75% Improvement in SCORAD (SCORAD75) From Baseline at All Scheduled Time Points|"SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome."|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
2553297|NCT02780167|Secondary|Percentage of Participants Achieving a >=50% Improvement in SCORAD (SCORAD50) From Baseline at All Scheduled Time Points|"SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome."|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
2553298|NCT02780167|Secondary|Percent Change From Baseline in SCORAD at All Scheduled Time Points|"SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome."|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percent change||Standard Deviation|Mean
2553332|NCT02778113|Secondary|PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon||Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment|All randomized participants with evaluable PK data. In the NG 0.5 mg arm, all participants had serum glucagon levels that were below the lower limit of quantification (100 pg/mL) except for one participant at one time point.|||hour (h)||Full Range|Median
2553299|NCT02780167|Secondary|Change From Baseline in Scoring Atopic Dermatitis (SCORAD) at All Scheduled Time Points|"SCORAD is a validated scoring index for AD, which combines extent (0-100), severity (0-18), and subjective symptoms (0-20) based on pruritus and sleep loss, each scored (0-10). Extent, denoted as A, is measured by BSA affected by AD as a percentage of the whole BSA. The score for each body region is added up to determine A (maximum of 100%). Severity, denoted as B, consists of the severity of several signs. Each is assessed as none(0), mild(1), moderate(2) or severe(3). The severity scores are added together to give B (maximum of 18). Subjective symptoms, denoted as C, are each scored by the subject or caregiver using a numeric rating scale (NRS) where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum of 20). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Higher values of SCORAD represent worse outcome."|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||units on a scale||Standard Deviation|Mean
2553300|NCT02780167|Secondary|Change From Baseline in Affected BSA at All Scheduled Time Points|BSA Efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA Efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. Since the scalp, palms, and soles are excluded from the BSA (Efficacy) assessment, the maximum possible value is less than 100%.|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of BSA||Standard Deviation|Mean
2553301|NCT02780167|Secondary|Percentage of Participants Achieving a >=90% Improvement in the EASI Total Score (EASI90) at All Scheduled Time Points|The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.|All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
2553302|NCT02780167|Secondary|Percentage of Participants Achieving a >=75% Improvement in the EASI Total Score (EASI75) at All Scheduled Time Points|The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.|All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
2553303|NCT02780167|Secondary|Percentage of Participants Achieving a >=50% Improvement in the EASI Total Score (EASI50) at All Scheduled Time Points|The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.|All scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
2553304|NCT02780167|Secondary|Change From Baseline in Pruritus NRS Score at All Scheduled Time Points|"The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on a NRS anchored by the terms no itching (0) and worst possible itching (10).~The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their frequency of itching due to AD over the past 24 hours on a NRS anchored by the terms never/no itching (0) and always/constant itching (10)."|Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||units on a scale||Standard Deviation|Mean
2553305|NCT02780167|Secondary|Percent Change From Baseline in the Pruritus NRS From Baseline at All Scheduled Time Points|"The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on a NRS anchored by the terms no itching (0) and worst possible itching (10).~The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their frequency of itching due to AD over the past 24 hours on a NRS anchored by the terms never/no itching (0) and always/constant itching (10)."|Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percent change||Standard Deviation|Mean
2553378|NCT02777827|Secondary|Time to Peak FEV1 at Day 1|The peak is the highest forced expiratory volume in one second (FEV1) value observed during the 6 hour-period immediately after the IP dose in the morning on Day 1.|5 mins, 15 mins, 30 mins, 1 h, 2 h, 4 h and 6 h post-dose on Day 1|All randomised participants who received investigational product, irrespective of protocol adherence and continued participation in the study|||Hours||Standard Deviation|Mean
2553306|NCT02780167|Secondary|Time to Achieving >=4 Points Improvement in NRS|"The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on a NRS anchored by the terms no itching (0) and worst possible itching (10).~The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their frequency of itching due to AD over the past 24 hours on a NRS anchored by the terms never/no itching (0) and always/constant itching (10)."|Baseline till Week 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||day||90% Confidence Interval|Median
2553307|NCT02780167|Secondary|Time to Achieving >=3 Points Improvement in NRS|"The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on a NRS anchored by the terms no itching (0) and worst possible itching (10).~The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their frequency of itching due to AD over the past 24 hours on a NRS anchored by the terms never/no itching (0) and always/constant itching (10)."|Baseline till Week 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||day||90% Confidence Interval|Median
2553308|NCT02780167|Secondary|Percentage of Participants Achieving >=4 Points Improvement in the Pruritus NRS From Baseline at All Scheduled Time Points|"The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on a NRS anchored by the terms no itching (0) and worst possible itching (10).~The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their frequency of itching due to AD over the past 24 hours on a NRS anchored by the terms never/no itching (0) and always/constant itching (10)."|Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
2553309|NCT02780167|Secondary|Percentage of Participants Achieving >=3 Points Improvement in the Pruritus Numerical Rating Scale (NRS) From Baseline at All Scheduled Time Points|"The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their worst itching due to AD over the past 24 hours on a NRS anchored by the terms no itching (0) and worst possible itching (10).~The frequency of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants were asked to assess their frequency of itching due to AD over the past 24 hours on a NRS anchored by the terms never/no itching (0) and always/constant itching (10)."|Baseline and all scheduled time points, including Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 29, 43, 57, 85, 99, 113|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
2553310|NCT02780167|Secondary|Percent Change From Baseline in the EASI Total Score at All Scheduled Time Points Except Week 12.|The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of BSA affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.|Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||Percent change||Standard Deviation|Mean
2553311|NCT02780167|Secondary|Percentage of Participants Achieving >=2 Points Improvement in the IGA From Baseline at All Scheduled Time Points|The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).|Baseline and all scheduled time points, including Weeks 1, 2, 4, 6, 8, 12, 13, 14, 16|"Number of Participants Analyzed represents the number of participants in the FAS population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
2553312|NCT02780167|Secondary|Percentage of Participants Achieving the IGA for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12|The IGA score quantifies the severity of participants' AD. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).|Baseline and all scheduled time points except Week 12, including Weeks 1, 2, 4, 6, 8, 13, 14, 16.|"Number of Participants Analyzed represents the number of participants in the full analysis set (FAS) population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants|||Number
2553313|NCT02780167|Secondary|Percent Change From Baseline in the Eczema Area and Severity Index (EASI) at Week 12|The EASI quantifies the severity of participants' AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. EASI is a composite scoring by the AD clinical evaluator of the degree of erythema, induration/population, excoriation, and lichenification (each scored separately) for each of 4 regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD.|Baseline and Week 12|"Number of Participants Analyzed represents the number of participants in the full analysis set (FAS) population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percent change||Standard Error|Least Squares Mean
2553333|NCT02778113|Secondary|PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon||Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment|All randomized participants with evaluable PK data. AUC(0-inf) could not be calculated for the NG 0.5 mg arm, because all participants had serum glucagon levels below the lower limit of quantification (100 pg/mL) except for one participant at one time point.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2553314|NCT02780167|Primary|Percentage of Participants Achieving the Investigator's Global Assessment (IGA) for Clear (0) or Almost Clear (1) and >=2 Points Improvement From Baseline at Week 12|The IGA score quantifies the severity of participants' atopic dermatitis (AD). Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate and severe, respectively).|Baseline and Week 12|"Number of Participants Analyzed represents the number of participants in the full analysis set (FAS) population. Number Analyzed at each visit represents the number of evaluable subjects for that visit."|||percentage of participants||Standard Error|Least Squares Mean
2553315|NCT02779543|Secondary|Sleep Efficiency as Measured by Fitbit Charge2 or Microsoft Band2.|Statistical analysis will examine agreement levels of sleep metrics such as Sleep Efficiency (SE)|1 night, approximately 9 hours.||||percentage of sleep efficiency||Standard Deviation|Mean
2553316|NCT02779543|Secondary|Wake Time After Sleep Onset as Measured by Fitbit Charge2 or Microsoft Band2.|Statistical analysis will examine agreement levels of sleep metrics such as Wake After Sleep Onset (WASO)|1 night, approximately 9 hours.||||minutes||Standard Deviation|Mean
2553317|NCT02779543|Secondary|Sleep Onset Latency as Measured by Fitbit Charge2 or Microsoft Band2.|Statistical analysis will examine agreement levels of sleep metrics such as Sleep Onset Latency (SOL).|1 night, approximately 9 hours.||||minutes||Standard Deviation|Mean
2553318|NCT02779543|Primary|Total Sleep Time as Measured by Fitbit Charge2 or Microsoft Band2.|Statistical analysis will examine agreement levels of sleep metrics such as Total Sleep Time (TST).|1 night, approximately 9 hours.||||minutes||Standard Deviation|Mean
2553319|NCT02779491|Secondary|App Usage|Number of days on which users interacted with the app.|Intervention end|Control participants did not receive the app, so no app data is available|||days used||Standard Deviation|Mean
2553320|NCT02779491|Secondary|Fruit and Vegetable Knowledge (Questionnaire Assessment)|FV knowledge will be assessed by the FV knowledge questionnaire published in Appleton et al. J Hum Nutr Diet, 2018;31:121-130. The questionnaire assessed four aspects of FV knowledge in relation to the UK 5-a-day recommendations. The portion sizes subscale is provided, where positive scores are given for correct responses, and negative scores for incorrect responses. Min. max scores are -27, 27. Higher scores show greater knowledge.|Intervention end|Intention-to-Treat|||scores on a scale||Standard Deviation|Mean
2553321|NCT02779491|Primary|Fruit and Vegetable Intakes (Self-report, Questionnaire Assessment)|Self-report, questionnaire assessment|Intervention end|Intention-to-Treat|||FV portions per day||Standard Deviation|Mean
2553322|NCT02779166|Primary|Time to Discharge Following Surgery|Total time to discharge from OR close following surgery, measured in minutes|time from OR to discharge, up to a maximum of 6 hours postoperatively||||minutes||Standard Deviation|Mean
2553323|NCT02779166|Primary|Total Narcotic Consumption in the Post Anesthesia Care Unit (PACU)|Monitored consumption of narcotic medications following surgery, measured in morphine equivalents|duration of PACU stay,immediate post op period up to a maximum of 4 hours postoperatively||||morphine milligram equivalents||Standard Deviation|Mean
2553324|NCT02779166|Primary|Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period|The pain VAS is a uni dimensional measure of pain intensity. It is a continuous scale comprised of a 0-10 pain rating. A score of 0 indicates no pain while a score of 10 would indicate extreme pain.|Pre operative on day of surgery, immediately following OR close, 1 hr post operatively, 2 hrs post operatively||||score on a scale||Standard Error|Mean
2553325|NCT02778555|Primary|Factor Analysis & PROMIS Correlation for Samples 2 & 3|"The validation process involves identifying, of the original 14 PCS items, which items show the largest factor loadings to the underlying factor structure that fits the data best, using model fit indices that will determine appropriate fit of the statistical model to the data, as well as convergent validity with other relevant measures (pain intensity, depression, anxiety, anger), which is tested through the use of Pearson correlations.~Metrics used to test the hypothesis: Intraclass correlations were used to establish variability. RMSEA, CFI, TLI, and WRMR as our goodness of fit indices for arriving at 3- and 5-item measures, and to compare the measures. Reliability was tested using α. Correlations between daily pain, mood, activity, sleep, and energy were tested using pearson coefficients.~Intent was to measure correlations between the brief PCS and the PROMIS for validation sample 2, and correlations between the brief PCS and the PROMIS for validation sample 3."|14 days||||Pearson Coefficients|||Number
2553326|NCT02778152|Secondary|Number of Participants Experiencing Second Degree Burns Post-Treatment|Incidence of skin burn within the first 48 hours after each of the 5 treatments|five months||||Participants|||Count of Participants
2553327|NCT02778152|Primary|Tolerability of Laser Treatment|Median of pain scores immediately post-laser treatment after each of the 5 treatments. Pain was assessed on a scale of 1 to 10, 10 being the greatest amount of pain.|five months||||score on a scale||Inter-Quartile Range|Median
2553328|NCT02778113|Secondary|PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax)||Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment|All randomized participants with evaluable PD data.|||millimole per liter (mmol/L)||Standard Error|Mean
2553329|NCT02778113|Secondary|PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose||Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment|All randomized participants with evaluable PD data.|||hour (h)||Full Range|Median
2553330|NCT02778113|Secondary|Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC₀₋₄) of Glucose||Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment|All randomized participants with evaluable PD data.|||millimole*hour per liter (mmol*h/L)||Standard Error|Mean
2553331|NCT02778113|Secondary|PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon||Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment|All randomized participants with evaluable PK data. In the NG 0.5 mg arm, all participants had serum glucagon levels that were below the lower limit of quantification (100 pg/mL) except for one participant at one time point.|||picogram per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2553351|NCT02777918|Secondary|Egg Intake|Egg intake over the follow-up period, assessed using an adapted FFQ.|6 months|ITT|||eggs||Standard Deviation|Mean
2553352|NCT02777918|Secondary|Lean Body Mass|Lean body mass over the intervention and follow-up period, assessed using bioimpedance|Change from baseline to 12 weeks|ITT|||g||Standard Deviation|Mean
2553334|NCT02778113|Secondary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon||Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment|All randomized participants with evaluable PK data. In the NG 0.5 mg arm, all participants had serum glucagon levels that were below the lower limit of quantification (100 picogram per milliliter [pg/mL]) except for one participant at one time point.|||picogram*hour per milliliter (pg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2553335|NCT02778113|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs)|"Safety and tolerability evaluated through the assessment of adverse events. A SAE (serious adverse event) was defined as any untoward medical occurrence in a clinical investigation, which did not necessarily have a causal relationship with this treatment.~A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section."|Baseline through Study Completion (Day 23)|All randomized participants who entered study period four.|||Participants|||Count of Participants
2553336|NCT02778100|Secondary|PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax) of Baseline-Adjusted Glucose||Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration|All enrolled participants with evaluable PD data.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2553337|NCT02778100|Secondary|PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose||Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration|All enrolled participants with evaluable PD data.|||Millimoles per liter (mmol/L)||Full Range|Median
2553338|NCT02778100|Secondary|Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC0-3) of Baseline-Adjusted Glucose From Time Zero up to 3 Hours||Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration|All enrolled participants with evaluable PD data.|||Hour*millimoles per liter(hr*mmol/L)||Standard Deviation|Mean
2553339|NCT02778100|Secondary|PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon||Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration|All enrolled participants with evaluable PK data.|||picograms per millilitre (pg/mL)||Standard Deviation|Mean
2553340|NCT02778100|Secondary|PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon||Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration|All enrolled participants with evaluable PK data.|||Hour (hr)||Full Range|Median
2553341|NCT02778100|Secondary|PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon||Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration|All enrolled participants with evaluable PK data.|||pg*hr/mL||Standard Deviation|Mean
2553342|NCT02778100|Secondary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon||Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration|All enrolled participants with evaluable PK data.|||picogram*hour per millilitre (pg*hr/mL)||Standard Deviation|Mean
2553343|NCT02778100|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs)|"Safety and tolerability evaluated through the assessment of adverse events.~A SAE (serious adverse event) was defined as any untoward medical occurrence in a clinical investigation participant administered the investigational product and which did not necessarily have a causal relationship with this treatment.~A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section."|Baseline up to Study Completion (Day 30)|All enrolled participants.|||Participants|||Count of Participants
2553344|NCT02778074|Primary|Depressive Symptoms Collected With the Patient Health Questionnaire-9 (PHQ-9)|The PHQ-9 is a nine-item instrument for measurement of depressive symptoms during the last two weeks. Each item is answered on a four graded scale where zero represents that the item do not affect the person and numbers one to three represents that the item affects the person several days to almost every day. The answers are summed to a total sum score, range 0-27, with higher numbers representing higher level of depressive symptoms. A cut off >5 represents minor depression and a cut off >10 represents major depression|Score at 9 weeks follow-up||||score on a scale||Standard Deviation|Mean
2553345|NCT02777944|Secondary|Number of Participants Who Volunteered to Provide Qualitative Feedback on the Motivate Program|Number of participants who volunteered to provide qualitative feedback on the Motivate Program|3 months|Qualitative feedback on the intervention program|||Participants|||Count of Participants
2553346|NCT02777944|Secondary|Number of Participants Who Accessed the Intervention Program|Number of participants who accessed the intervention program|3 months|Number of participants who accessed the intervention program|||Participants|||Count of Participants
2553347|NCT02777944|Primary|Number of Participants Who Attended Initial Assessment Appointment|Attendance at initial assessment appointment|3 months|Number of participants who attended initial assessment appointment|||Participants|||Count of Participants
2553348|NCT02777931|Primary|Clinical Global Impression - Global Improvement (CGI -I) Response|"The CGI-I item is rated on a 7-point scale from 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse.~Response is defined as achieving a CGI-I score of 1 or 2, scores of 3 to 7 or missing are defined as Non Response"|Visit 3 to Visit 8 (Week 6)|Modified Intent to Treat Population = all randomized subjects who took at least one dose of randomized study drug and have a valid baseline assessment and at least 1 valid post baseline assessment.|||Participants|||Count of Participants
2553349|NCT02777931|Primary|Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale, Version 5 (ADHD-RS-5) Total Score|"The ADHD-RS-5 is comprised of 18 frequency items and 12 impairment items. Each frequency item was scored on a scale from 0 = Never or rarely to 3 = Very often.~The ADHD-RS-5 total score was calculated as the sum of the 18 frequency item scores. The total score ranges from 0 to 54. Higher scores indicate greater symptom severity. Change from baseline value were calculated as the assessment value minus the baseline value."|Baseline to Visit 8 (Week 6)|Modified Intent to Treat Population = all randomized subjects who took at least one dose of randomized study drug and have a valid baseline assessment and at least 1 valid post baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2553350|NCT02777918|Secondary|Number of Adverse Events Reported|Self-declared adverse events over the follow-up period, assessed by questionnaire|6 months|ITT|||Number of adverse events reported||Standard Deviation|Mean
2553353|NCT02777918|Secondary|Muscle Function|Muscle function over the intervention and follow-up period, assessed using the Short Physical Performance Battery (Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. (1994) A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol 49:M85-M94). Higher scores denote better ability - range - 5.0 to +5.0.|Change from baseline to 12 weeks|ITT|||scores on a scale||Standard Deviation|Mean
2553354|NCT02777918|Secondary|Change in Dietary Protein Intake|Change in dietary protein intake over the intervention and follow-up period, assessed using an adapted FFQ|Change from baseline to 12 weeks|ITT|||g/day||Standard Deviation|Mean
2553355|NCT02777918|Primary|Adverse Events|Self-declared adverse events over the intervention period, assessed by questionnaire|Change from baseline to 12 weeks|ITT|||Adverse events||Standard Deviation|Mean
2553356|NCT02777918|Primary|Egg Intake|Egg intake at the end of the intervention period, assessed using an adapted Food Frequency Questionnaire (FFQ)|Change from baseline to 12 weeks|ITT|||eggs||Standard Deviation|Mean
2553357|NCT02777827|Secondary|Change From Baseline in Normalised FVC AUC0-24.|"Change from baseline in normalised FVC area under the concentration curve for Abediterol from time zero to 24 hours post-dose.~Baseline for FVC was defined as the mean of the 2 measured values for the corresponding variable (2 measurements 30 min apart, at -45 min and -15 min before the morning IP administration). If both values were missing, the screening value (pre-bronchodilator FVC from Visit 2) was used instead."|45 mins and 15 mins predose, and 5 mins, 15 mins, 30 mins, 1 h, 2 h, 4 h, 6 h, 12 h, 16 h, 22 h, and 23.00-24.00 h post-dose on Day 1|All randomised participants who received investigational product, irrespective of protocol adherence and continued participation in the study|||Liters||Standard Error|Least Squares Mean
2553358|NCT02777827|Secondary|Change From Baseline in Trough FVC.|"Baseline for FVC was defined as the mean of the two measured values for the corresponding variable (2 measurements 30 min apart, at -45 min and -15 min), prior to the morning investigational product (IP)administration on Day 1 of each treatment period. If both were missing the screening value was used instead.~Trough was defined as the mean of the FEV1 values obtained at 23 h and 24 h after the morning IP administration. If one of the values was missing, the other one was used as trough."|45 mins and 15 mins pre-dose, and 23.00-24.00 h post-dose on Day 1|All randomised participants who received investigational product, irrespective of protocol adherence and continued participation in the study|||Liters||Standard Error|Least Squares Mean
2553359|NCT02777827|Secondary|Change From Baseline in Peak FVC.|"Baseline for FVC was defined as the mean of the 2 measured values for the corresponding variable (2 measurements 30 min apart, at -45 min and -15 min before the morning IP administration). If both values were missing, the screening value (pre-bronchodilator FEV1 from Visit 2) was used instead.~The peak is the highest forced vital capacity (FVC) value observed during the 6 hour-period immediately after the IP dose in the morning on Day 1."|Predose and 5 mins, 15 mins, 30 mins, 1 h, 2 h, 4 h and 6 h post-dose on Day 1|All randomised participants who received investigational product, irrespective of protocol adherence and continued participation in the study|||Liters||Standard Error|Least Squares Mean
2553360|NCT02777827|Secondary|Change From Baseline in Normalised FEV1 AUC12-24.|"Change from baseline in normalised FEV1 area under the concentration-curve for Abediterol from time 12 hours post-dose to 24 hours post-dose.~Baseline for FEV1 was defined as the mean of the 2 measured values for the corresponding variable (2 measurements 30 min apart, at -45 min and -15 min before the morning IP administration). If both values were missing, the screening value (pre-bronchodilator FEV1 from Visit 2) was used instead."|45 mins and 15 mins predose, and 12 h, 16 h, 22 h, and 23.00-24.00 h post-dose on Day 1|All randomised participants who received investigational product, irrespective of protocol adherence and continued participation in the study|||Liters||Standard Error|Least Squares Mean
2553361|NCT02777827|Secondary|Change From Baseline in Normalised FEV1 AUC0-6.|"Change from baseline in normalised FEV1 area under the concentration-curve for Abediterol from time zero to 6 hours post-dose.~Baseline for FEV1 was defined as the mean of the 2 measured values for the corresponding variable (2 measurements 30 min apart, at -45 min and -15 min before the morning IP administration). If both values were missing, the screening value (pre-bronchodilator FEV1 from Visit 2) was used instead."|45 mins and 15 mins predose, and 5 mins, 15 mins, 30 mins, 1 h, 2 h, 4 h, and 6 h post dose on Day 1|All randomised participants who received investigational product, irrespective of protocol adherence and continued participation in the study|||Liters||Standard Error|Least Squares Mean
2553362|NCT02777827|Secondary|Change From Baseline in Normalised FEV1 AUC0-12.|"Change from baseline in normalised FEV1 area under the concentration time curve for Abediterol from time zero to 12 hours post-dose.~Baseline for FEV1 was defined as the mean of the 2 measured values for the corresponding variable (2 measurements 30 min apart, at -45 min and -15 min before the morning IP administration). If both values were missing, the screening value (pre-bronchodilator FEV1 from Visit 2) was used instead."|45 mins and 15 mins predose, and 5 mins, 15 mins, 30 mins, 1 h, 2 h, 4 h, 6 h, and 12 h post-dose on Day 1|All randomised participants who received investigational product, irrespective of protocol adherence and continued participation in the study|||Liters||Standard Error|Least Squares Mean
2553363|NCT02777827|Secondary|Change From Baseline in Normalised FEV1 AUC0-24.|"Change from baseline in normalised FEV1 area under the concentration-curve of Abediterol from time zero to 24 hours post-dose.~Baseline for FEV1 was defined as the mean of the 2 measured values for the corresponding variable (2 measurements 30 min apart, at -45 min and -15 min before the morning IP administration). If both values were missing, the screening value (pre-bronchodilator FEV1 from Visit 2) was used instead."|45 mins and 15 mins predose, and 5 mins, 15 mins, 30 mins, 1 h, 2 h, 4 h, 6 h, 12 h, 16 h, 22 h, and 23.00-24.00 h post-dose on Day 1|All randomised participants who received investigational product, irrespective of protocol adherence and continued participation in the study|||Liters||Standard Error|Least Squares Mean
2553364|NCT02777827|Secondary|Change From Baseline in Peak FEV1.|The peak is the highest forced expiratory volume in one second (FEV1) value observed during the 6 hour-period immediately after the IP dose in the morning on Day 1.|Predose and 5 mins, 15 mins, 30 mins, 1 h, 2 h, 4 h and 6 h post-dose on Day 1|All randomised participants who received investigational product, irrespective of protocol adherence and continued participation in the study|||Liters||Standard Error|Least Squares Mean
2560616|NCT02662569|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and week 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
2553365|NCT02777827|Secondary|Percentage of Participants Achieving a ≥ 200 mL and ≥12% Increase From Baseline in Trough FEV1.|The percentage of patients achieving at least 200 mL and 12% increase from baseline in trough forced expiratory volume in one second (FEV1). Trough was defined as the mean of the FEV1 values obtained at 23 hours and 24 hours after the morning IP administration.|Predose and 5 mins, 15 mins, 30 mins, 1 h, 2 h, 4 h and 6 h post-dose on Day 1|All randomised participants who received investigational product, irrespective of protocol adherence and continued participation in the study|||Percentage of patients|||Number
2553366|NCT02777827|Secondary|Time to Peak FVC at Day 1|The peak is the highest forced vital capacity (FVC) value observed during the 6 hour-period immediately after the IP dose in the morning on Day 1.|5 mins, 15 mins, 30 mins, 1 h, 2 h, 4 h and 6 h post-dose on Day 1|All randomised participants who received investigational product, irrespective of protocol adherence and continued participation in the study|||Hours||Standard Deviation|Mean
2553367|NCT02777827|Secondary|Number of Participants With Post-baseline Potentially Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters|"Standard 12-lead ECG evaluations were performed prior to IP administration and 1, 4 and 24 h post IP administration at randomisation and after each IP administration. ECGs were recorded after approximately 5 minutes resting in supine position before any blood sampling and spirometry test, preferably always by the same technician for each patient.~Clinically significant abnormalities were defined as listed in the table below for QT interval, QTcB, QTcF, QRS interval, PR interval and heart rate (HR).~BL incr. = increase from baseline."|Up to last treatment visit (Day 112)|All randomised participants who received at least one dose of investigational product|||Participants|||Number
2553368|NCT02777827|Secondary|Number of Participants With Any Treatment-emergent Adverse Event|All treatment emergent adverse events (TEAEs), including serious AEs. An AE is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An AE was considered a TEAE if it was not present prior to the date of the first dose of IP or was present prior to the date of the first dose of IP, but increased in severity after IP administration.|From screening (Day -14) up to follow-up phone call (14 days after last IP administration).|All randomised participants who received at least one dose of investigational product|||Number of participants|||Number
2553369|NCT02777827|Secondary|Mean Residence Time (MRT) of Abediterol.|Mean residence time (h), calculated by AUMC/AUC, where AUMC is the area under the first moment-time curve (MRT).|Pre-dose, 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1.|The PK analysis set, defined as all randomised subjects who took at least one dose of IP and had at least one evaluable relevant PK parameter|||Hours||Geometric Coefficient of Variation|Geometric Mean
2553370|NCT02777827|Secondary|Apparent Volume of Distribution for Abediterol at Terminal Phase (Vz/F).|Apparent volume of distribution for parent drug at terminal phase, estimated by dividing the apparent clearance (CL/F) by λz (Vz/F).|Pre-dose, 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1.|The PK analysis set, defined as all randomised subjects who took at least one dose of IP and had at least one evaluable relevant PK parameter|||Liters||Geometric Coefficient of Variation|Geometric Mean
2553371|NCT02777827|Secondary|Apparent Plasma Clearance for Abediterol (CL/F).|Apparent plasma clearance for parent drug estimated as dose divided by AUC (CL/F).|Pre-dose, 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1.|The PK analysis set, defined as all randomised subjects who took at least one dose of IP and had at least one evaluable relevant PK parameter|||L/h||Geometric Coefficient of Variation|Geometric Mean
2553372|NCT02777827|Secondary|AUC of Abediterol.|"Area under the Abediterol concentration-time curve from time zero extrapolated to infinity (AUC). AUC is estimated by AUClast + Clast/λz where Clast is the last observed quantifiable concentration (AUC).~PK blood samples were collected 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1 (Note that 24 h and 36 h time-points post-dose correspond to Day 2)."|Pre-dose, 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1.|The PK analysis set, defined as all randomised subjects who took at least one dose of IP and had at least one evaluable relevant PK parameter.|||pg.h/mL||Geometric Coefficient of Variation|Geometric Mean
2553373|NCT02777827|Secondary|AUClast of Abediterol|Area under the plasma concentration-curve of Abediterol from time zero to the time of last quantifiable analyte concentration.|Pre-dose, 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1.|The PK analysis set, defined as all randomised subjects who took at least one dose of IP and had at least one evaluable relevant PK parameter.|||pg.h/mL||Geometric Coefficient of Variation|Geometric Mean
2553374|NCT02777827|Secondary|Terminal Half-life (h) of Abediterol (t½λz)|Terminal half-life (h), estimated as (ln2)/λz (t1/2λz).|Pre-dose, 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1.|The PK analysis set, defined as all randomised subjects who took at least one dose of IP and had at least one evaluable relevant PK parameter.|||Hours||Standard Deviation|Mean
2553375|NCT02777827|Secondary|Terminal Rate Constant of Abediterol (λz)|Terminal rate constant (λz) of Abediterol, estimated by log-linear least square regression of the terminal part of the concentration-time curve.|Pre-dose, 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1.|The PK analysis set, defined as all randomised subjects who took at least one dose of IP and had at least one evaluable relevant PK parameter.|||l/hour||Standard Deviation|Mean
2553376|NCT02777827|Secondary|Time (h) to Maximum Concentration of Abediterol (Tmax).|Time to maximum concentration (Tmax) of Abediterol (h), taken directly from the individual concentration-time curve.|Pre-dose, 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1.|The PK analysis set, defined as all randomised subjects who took at least one dose of IP and had at least one evaluable relevant PK parameter.|||Hours||Full Range|Median
2553377|NCT02777827|Secondary|Observed Maximum Concentration of Abediterol (Cmax)|Observed maximum concentration (Cmax) of Abediterol, taken directly from the individual concentration-time curve.|Pre-dose, 5, 15, 30, and 45 minutes, at 1, 2.5, 4, 6, 8, 12, 24 and 36 hours after IP administration on Day 1.|The PK analysis set, defined as all randomised subjects who took at least one dose of IP and had at least one evaluable relevant PK parameter.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2553379|NCT02777827|Secondary|Percentage of Participants Achieving a ≥ 200 mL and ≥12% Increase From Baseline in Peak FEV1 on Day 1.|The percentage of patients achieving at least 200 mL and 12% increase from baseline in peak FEV1 on Day 1 of each treatment. The peak was the highest value observed during the 6 hour-period immediately after the IP dose in the morning on Day 1.|Predose and 5 mins, 15 mins, 30 mins, 1 h, 2 h, 4 h and 6 h post-dose on Day 1|All randomised participants who received investigational product, irrespective of protocol adherence and continued participation in the study|||Percentage of participants|||Number
2553380|NCT02777827|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1).|"Baseline for FEV1 was defined as the mean of the two measured values for the corresponding variable (2 measurements 30 min apart, at -45 min and -15 min), prior to the morning investigational product (IP) administration on Day 1 of each treatment period. If both were missing the screening value was used instead.~Trough is defined as the mean of the FEV1 values obtained at 23 h and 24 h after the morning IP administration. If one of the values was missing, the other one was used as trough."|45 mins and 15 mins pre-dose, and 23.00-24.00 h post-dose on Day 1|All randomised participants who received investigational product, irrespective of protocol adherence and continued participation in the study|||Liters||Standard Deviation|Mean
2553381|NCT02777749|Secondary|Length of Hospital Stay|Total length of hospital stay from time of surgery through time of discharge will be recorded. The shorter the length of stay (days) the better. Range 0 days to 5 days.|Up to Day 5||||days||Standard Deviation|Mean
2553382|NCT02777749|Secondary|Range of Knee Flexion|Range of knee flexion for active motion will be recorded at 3 week follow-up for all groups. The greater range of motion the better, with a good outcome considered at least 115 degrees of motion.|Postoperative day 21||||degrees||Standard Deviation|Mean
2553383|NCT02777749|Secondary|Opioid Consumption|Total amount of opioid consumption post-operatively will be recorded. The less opioids consumed (mg) postoperatively the better. A morphine equivalence metric will be used for equianalgesic comparison. Minimum is 0 mg, maximum is unlimited.|Day 0 through Day 3||||morphine equivalents||Standard Deviation|Mean
2553384|NCT02777749|Secondary|Change in Activity Level|Daily steps taken will be recorded. The more steps taken daily the better. Minimum is 0 steps, maximum is unlimited.|Day 0 and Day 1||||steps||Standard Deviation|Mean
2553385|NCT02777749|Primary|Change in VAS Pain Scores|"Post-operatively, visual analog scale (VAS) pain scores will be recorded two times/day from Post-Operative Day (POD) 0 through POD3. VAS Scores range from 0 to 10, with 0 being No Pain and 10 being the Worst Pain"|Day 0 through Day 3||||scores on a scale||Standard Deviation|Mean
2553386|NCT02777268|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as Assessed by Medical Dictionary for Regulatory Activities (MedDRA) Dictionary, Version 16.0.|To assess the safety and tolerability of Infacort® throughout the study. For a full list of TEAEs per arm, please refer to the Adverse Events section.|1 day||||TEAEs|||Number
2553387|NCT02777268|Secondary|Area Under the Curve (AUC0-t) of Infacort at Doses of 0.5, 2, 5 and 10 mg|To determine the dose proportionality for Infacort® at doses of 0.5 mg, 2 mg, 5 mg and 10 mg.|1 day||||H*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2553388|NCT02777268|Secondary|Time to Maximum Plasma Concentration (Tmax) of Infacort at Doses of 0.5, 2, 5 and 10 mg|To determine the dose proportionality for Infacort® at doses of 0.5 mg, 2 mg, 5 mg and 10 mg.|-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h||||Hours||Standard Deviation|Median
2553389|NCT02777268|Secondary|Maximum Plasma Concentration (Cmax) of Infacort at Doses of 0.5, 2, 5 and 10 mg|To determine the dose proportionality for Infacort® at doses of 0.5 mg, 2 mg, 5 mg and 10 mg.|-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h||||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2553390|NCT02777268|Primary|Area Under the Curve (AUC0-t) of Infacort vs Hydrocortisone|To compare the AUC0-t of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg. AUC0-t represents the total exposure to drug over time, hence the reporting of a single value below.|-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h|Two subjects were excluded from the Infacort 10mg analysis population due to inadequate endogenous cortisol suppression prior to dosing.|||hr*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2553391|NCT02777268|Primary|Time to Reach the Maximum Plasma Concentration (Tmax) of Infacort vs Hydrocortisone|To compare the Tmax of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg.|-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h|Two subjects were excluded from the Infacort 10mg analysis population due to inadequate endogenous cortisol suppression prior to dosing.|||Hour||Standard Deviation|Median
2553392|NCT02777268|Primary|Maximum Plasma Concentration (Cmax) of Infacort vs Hydrocortisone|To compare the Cmax of Infacort® versus immediate-release hydrocortisone in a single dose of 10 mg.|-1h, -0.5h, 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h|Two subjects were excluded from the Infacort 10mg analysis population due to inadequate endogenous cortisol suppression prior to dosing.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2553393|NCT02777242|Primary|Number of Patients With Adverse Events Receiving Testosterone Enanthate Via QST Auto-injector.|Intended users were patients experiencing an adverse event that was considered to be a TEAE if the adverse event started on or after randomization, or existed prior to randomization and worsened in severity or relatedness to QST (QuickShot® Testosterone auto-injector) after randomization.|3 weeks||||Participants|||Count of Participants
2553394|NCT02777125|Secondary|Number of Participants Requiring Repeat Visits|Defined as a repeat visit to the Emergency Department for a complaint related to their wheezing, within 7 days of initial enrollment in the study.|Within 7 days of initial presentation||||Participants|||Count of Participants
2553395|NCT02777125|Secondary|Number of Patients Requiring Ondansetron Dosing|Defined as a patient needing ondansetron for symptomatic relief of their nausea after initiating therapy in the Emergency Department.|6 hours||||Participants|||Count of Participants
2553531|NCT02774681|Other Pre-specified|Change in Genomic Landscape of Available CNS and Non-CNS Tumors|To evaluate genomic landscape of available CNS and non-CNS tumors, and describe any discordance. Genotyping of CNS and non-CNS tumors will be performed from archival tissue that will be obtained at baseline. Genotyping will be performed through commercial next generation sequencing assays.|At baseline|||||||
2553396|NCT02777125|Secondary|Number of Patients With Tachycardia After Treatment|Defined as anytime after initiation of therapy when the patient's heart rate exceeded age adjusted normal sinus rhythm heart rates for their age. Not uncommonly, patient's experience tachycardia as an unintended side effect of receiving albuterol. Tachycardia can result in a patient requiring further observation in the Emergency department and therefore increasing Emergency Department length of stay. We want to determine if indeed tachycardia is unavoidable, or if its presence suggests that patients are receiving too much albuterol or if albuterol is being given by the wrong appliance.|6 hours||||Participants|||Count of Participants
2553397|NCT02777125|Secondary|Emergency Department Length of Stay|Emergency department length of stay is defined as the point of time when the patient checked into the Emergency Department to the time of final disposition.|6 hours||||minutes||Standard Deviation|Mean
2553398|NCT02777125|Primary|Number of Participant's Admitted to the Hospital for Further Treatment|Patient disposition is measured as subjects requiring further treatment and being admitted to hospital. We record the number of patients in each cohort that required admission to the hospital after being evaluated and treated in the Emergency Department.|6 hours||||Participants admitted to the Hospital|||Number
2553399|NCT02777021|Secondary|Responses From Structured Patient-centered Outcome Surveys|Information from semi-structured patient outcome surveys completed by patients and caregivers will be collected to evaluate the relationship between neutropenia management strategy (inpatient versus outpatient) and outcomes reported by patients and caregivers.|1 Course of Chemotherapy (Approximately 30-40 days)|||||||
2553400|NCT02777021|Primary|Compare Differences in HRQOL Scores Between Outpatient Versus Inpatient Management|1 Course of Chemotherapy (Approximately 30-40 days). The primary outcome of interest was patient health-related quality of life (HRQOL) measured using the acute PedsQL™ 4.0 Generic Core Scales.31 These scales use a 7-day time frame. The multidimensional assessment includes items in four domains: physical functioning, emotional functioning, social functioning, and school functioning. Respondents document responses to each question using a 5-point Likert scale anchored by never a problem (0) to almost always a problem (4). PedsQL™ items were reverse scored and linearly transformed to a scale of 0 to 100 such that higher scores reflect better HRQOL.|PedsQL assessments were administered at two points - at the start of the study-contributed chemotherapy course prior to the patient becoming neutropenic (baseline) and again within the period between neutropenia resolution (follow-up); follow-up reported.|Participants who completed evaluable PedsQL follow-up surveys.|||score on a scale||Standard Deviation|Mean
2553401|NCT02776904|Primary|Psychomotor Vigilance Task (PVT)|The PVT is a reliable and valid measurement of simple reaction time to an auditory cue. The outcome measure will be the mean reaction time.|cross-sectional baseline|Subset of healthy athletes. The Concussed athlete data for the PVT (as was the ImPACT concussed data) was used clinically to assess individual auditory reaction time and for clinical decision making by the medical team. The concussed PVT data will not be used as aggregate data.|||ms||Standard Deviation|Mean
2553402|NCT02776904|Primary|Y Balance Assessment- Postero-medial Reach Direction|subset from healthy athlete group and concussed group Measured on YBT in postero-medial direction.|Cross sectional baseline|Data are not mutually exclusive. Reported for Y balance test divided into male and female groups and healthy and concussed athletes. Data for concussed subjects is reported in the acute phase and divided into male and female groups.|||Index||Standard Deviation|Mean
2553403|NCT02776904|Primary|Y Balance Assessment- Posterolateral Reach Direction|subset from healthy athlete group and concussed group Measured on YBT in postero-lateral direction.|Cross sectional baseline|Data are not mutually exclusive. Reported for Y balance test divided into male and female groups and healthy and concussed athletes. Data for concussed subjects is reported in the acute phase and divided into male and female groups.|||Index||Standard Deviation|Mean
2553404|NCT02776904|Primary|Y Balance Assessment- Anterior Reach Direction|subset from healthy athlete group and concussed group Measured on YBT in anterior direction|Cross sectional baseline|Data are not mutually exclusive. Reported for Y balance test divided into male and female groups. Data for concussed subjects is reported in the acute phase and divided into male and female groups.|||Index||Standard Deviation|Mean
2553405|NCT02776904|Primary|Gait Parameters- % of Gait Cycle in SLS|For the purposes of this study, parameters that were captured by the GAITRite® include: SLS, defined as the %GC weight bearing through a single limb.|cross-sectional baseline|Data are not mutually exclusive. Reported for single task and dual task and divided into male and female groups as well as healthy and concussed athletes.|||percentage of gait cycle spent on 1 limb||Standard Deviation|Mean
2553406|NCT02776904|Primary|Gait Parameters- Percent of DLS|DLS, defined as the percent of the gait cycle (%GC) when both feet are on the ground measured in healthy males and female athletes and concussed males and female athletes|cross-sectional baseline|Data are not mutually exclusive. Reported for single task and dual task and divided into male and female groups and healthy and concussed athletes.|||percentage of GC spent on 2 limbs||Standard Deviation|Mean
2553407|NCT02776904|Primary|Gait Parameters: Step Length (Cm)|For the purposes of this study, parameters that were captured by the GAITRite® include:step length (cm);|cross-sectional baseline|Data are not mutually exclusive. Reported for single task and dual task and divided into male and female groups and healthy and concussed athletes|||cm||Standard Deviation|Mean
2553408|NCT02776904|Primary|Spatiotemporal Gait Parameters- Gait Velocity|For the purposes of this study, parameters that were captured by the GAITRite® include: gait velocity (cm/s); Subjects walk on pathway during single task and dual task is walking while performing a visual memory task on a tablet|Cross-sectional baseline|Data are not mutually exclusive. Reported for single task and dual task and divided into male and female groups.|||cm/sec||Standard Deviation|Mean
2553409|NCT02776904|Primary|Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete|Reaction time Composite is the average correct reaction time of 3 skills Scores range from 0.5 to 0.7 Lower scores are better.|preseason, postseason and end of the school year and preseason the following year|subset from healthy athlete group Measured on Reaction time composite score (Immediate Post Concussion Assessment)|||seconds||Standard Error|Mean
2553532|NCT02774681|Other Pre-specified|Change in Cognitive Function in Patients Receiving Palbociclib|Change in cognitive function will be assessed at baseline, 2 months and 4 months and will be collected using patient reported outcome questionnaires: Functional assessment of Cancer Therapy-Cognitive function Version 3.0 (Fact -Cog)|At baseline, 2 months and 4 months|||||||
2553410|NCT02776904|Primary|Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete|"Verbal memory (total % correct from design memory, total correct from memory score from X's and O's) and visual memory (total number correct/4 during module 3) Scores on verbal memory and visual memory range from 70-99 (high scores are better than low scores).~Visual motor speed is comprised correct responses/4 for specific modules and the average counted correctly x3 for a specific module.~Scores range from 27-39.8 (high scores are better than low scores)"|preseason, postseason, end of the school year, pre-season year 2|subset from healthy athlete group|||score on Immediate post concussion scale||Standard Error|Mean
2553411|NCT02776774|Secondary|Describe Surgeon Practices for Using Intra-wound Antibiotics for Spine Surgery|The investigators will survey surgeons about their current use of intra-wound antibiotics for spine surgery|Baseline|Spine surgeons|||Participants|||Count of Participants
2553412|NCT02776774|Primary|Surgeon Attitudes About Using Intra-wound Antibiotics for Spine Surgery|The investigators will compare answers to survey questions about knowledge of IWA among a diverse surgeon population to assess the feasibility of a future RCT and need for additional evidence.|Baseline|"Spine surgeon opinion regarding if intra-wound antibotic use for spine procedures is the standard of care?"|||Participants|||Count of Participants
2553413|NCT02776683|Secondary|Progression-Free Survival (PFS) Time as Assessed by Central Imaging Review|"PFS was defined as the time from first administration of trial medication until disease progression as assessed by central imaging review or death due to any cause. Disease progression was assessed according to RECIST 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize) or worsen (progress) during treatment. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. PFS was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method."|Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks).|TS: The TS contained all patients who signed informed consent and who received at least one dose of trial medication.|||Months||95% Confidence Interval|Median
2553414|NCT02776683|Secondary|Overall Survival (OS) Time|OS was defined as the time from first administration of trial medication until death from any cause. OS was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method.|From date of first dose of trial medication until last date of trial medication + 18 weeks (REP), up to a maximum of 32 treatment cycles + safety follow up (up to 82 weeks overall).|TS: The TS contained all patients who signed informed consent and who received at least one dose of trial medication.|||Months||95% Confidence Interval|Median
2553415|NCT02776683|Secondary|Objective Response (OR) Rate as Assessed by Central Imaging Review|"OR rate was defined as the percentage of patients who achieved at least one visit response of CR (CR is disappearance of all target lesions) or PR (PR is at least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters) after the start of treatment. The response criteria evaluation was carried out according to RECIST 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize) or worsen (progress) during treatment. Confidence interval was calculated using Wilson score method. The definition for OR (CR/PR) extends until disease progression/ death/ unacceptable toxicity/ end of the trial, whichever occurred earlier. However for Duration of response this censoring does not apply. Hence the apparent discrepancy.~OR = CR + PR."|Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks).|TS: The TS contained all patients who signed informed consent and who received at least one dose of trial medication.|||Percentage of participants||95% Confidence Interval|Number
2553416|NCT02776683|Secondary|Time to Progression (TTP) as Assessed by Central Imaging Review|"TTP was defined as the time from first administration of trial medication to the date of tumor progression as assessed by central imaging review per RECIST 1.1 (RECIST is a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize) or worsen (progress) during treatment.). TTP was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method."|Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks).|TS: The TS contained all patients who signed informed consent and who received at least one dose of trial medication.|||Months||95% Confidence Interval|Median
2553417|NCT02776683|Secondary|Duration of Response (DOR) as Assessed by Central Imaging Review|"DOR was the time from first documented Complete Response (CR) (CR is disappearance of all target lesions) or Partial Response (PR) (PR is at least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters) until time of progression as assessed by central imaging review per Response evaluation criteria in solid tumors (RECIST) 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize) or worsen (progress) during treatment. DOR was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method."|Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks).|TS: The TS contained all patients who signed informed consent and who received at least one dose of trial medication. Only patients with complete or partial objective response were included in the analysis.|||Months||95% Confidence Interval|Median
2553452|NCT02776033|Primary|Change From Baseline in Heart Rate|Heart rate was measured at indicated time points in supine or semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment. Change from Baseline is defined as any post-dose visit value minus Baseline value.|Baseline (Pre-dose on Day 1), Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85 and Follow-up (Day 116)|Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).|||Beats per minute||Standard Deviation|Mean
2553418|NCT02776683|Primary|Percentage of Patients With Treatment-Emergent Adverse Events (TEAEs) in the Specified Categories Selected for Primary Endpoint Assessment|"The primary safety endpoint of the trial was patients with any of the following selected adverse events (AEs):~Infusion reactions (anaphylactic/hypersensitivity/infusion-related reactions),~Thromboembolic events (arterial or venous),~Gastrointestinal perforations,~Hypertension,~Proteinuria,~Pulmonary hemorrhage~All hemorrhages (including pulmonary hemorrhages)~Wound-healing complications/abscess/fistulas~Posterior reversible encephalopathy syndrome~Ovarian failure. All AEs with an onset between start of treatment and end of the residual effect period (REP), a period of 18 weeks after the last dose of trial medication were considered for the primary safety analysis. Confidence interval was calculated using Wilson score method."|From baseline up to 18 weeks after the last dose of trial medication prior to the Switch Visit. Maximum duration of up to 32 treatment cycles + safety follow up (up to 82 weeks overall).|Treated set (TS): The TS contained all patients who signed informed consent and who received at least one dose of trial medication.|||Percentage of participants (%)||95% Confidence Interval|Number
2553419|NCT02776670|Secondary|Mean Change From Baseline in Global Ocular Discomfort Visual Analog Scale (VAS) Score at Day 35|Ocular discomfort frequency and severity (each graded on a separate 100-units scale) were assessed using a visual analog scale (VAS). Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past week' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past week' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for the given visit, as the square root of the product of the ocular discomfort frequency score multiplied by the ocular discomfort severity score. Improvement results in a reduction of the ocular discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline. A negative change from baseline indicates improvement.|Baseline (Day 0), Day 35|Full Analysis Set. At each time point, only subjects with a value at both Baseline and that time point are included.|||units on a scale||Standard Deviation|Mean
2553420|NCT02776670|Secondary|Lipid Layer Thickness (LLT) Area Under the Curve (AUC120) at Day 35|LLT was measured using the LipiView® Ocular Surface Interferometer, an ophthalmic imaging device intended for use in adult patients to capture, archive, manipulate and store digital images of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented. Using these images, the LipiView® Interferometer measures the absolute thickness of the tear film lipid layer.|Day 35|Area under the curve (AUC) lipid layer thickness (LLT) was removed from formal analysis as a secondary endpoint via amendment of the standalone Statistical Analysis Plan (SAP) due to a large proportion of data that were above the limit of detection.||||||
2553421|NCT02776670|Secondary|Change From Baseline in TFBUT at Day 35|TFBUT (the time required for dry spots to appear on the surface of the eye after blinking) was assessed with a fluorescein strip and measured in seconds. Using a stopwatch, the investigator measured the time from the last blink until one or more black (dry) spots appeared in the precorneal tear film. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. Only one eye (analysis eye) contributed to the analysis.|Baseline (Day 0), Day 35|Full Analysis Set. At each time point, only subjects with a value at both Baseline and that time point are included.|||seconds||Standard Error|Least Squares Mean
2553422|NCT02776670|Primary|Mean Change From Baseline in Tear Film Break-Up Time (TFBUT) at Day 35|TFBUT (the time required for dry spots to appear on the surface of the eye after blinking) was assessed with a fluorescein strip and measured in seconds. Using a stopwatch, the investigator measured the time from the last blink until one or more black (dry) spots appeared in the precorneal tear film. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. Only one eye (analysis eye) contributed to the analysis.|Baseline (Day 0), Day 35|Per Protocol Analysis Set. At each time point, only subjects with a value at both Baseline and that time point are included.|||seconds||Standard Deviation|Mean
2553423|NCT02776644|Primary|Number of Participants Who Received Antihypertensive Medication From Month 6 to Month 12|To calculate number of patient receiving antihypertensive prescriptions from Month 6 to Month 12 for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.|Month 6 up to Month 12 since Sunitinib or Pazopanib initiation (during the observation period of 11 years)|All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2553424|NCT02776644|Primary|Number of Participants Who Received Antihypertensive Medication From Month 3 to Month 6|To calculate number of patient receiving antihypertensive prescriptions from Month 3 to Month 6 for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.|Month 3 up to Month 6 since Sunitinib or Pazopanib initiation (during the observation period of 11 years)|All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2553425|NCT02776644|Primary|Number of Participants Who Received Antihypertensive Medication From Month 1 to Month 3|To calculate number of patient receiving antihypertensive prescriptions from Month 1 to Month 3 for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.|Month 1 up to Month 3 since Sunitinib or Pazopanib initiation (during the observation period of 11 years)|All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2553926|NCT02766608|Primary|Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI Versus FF MDI)|Change from baseline in morning pre-dose trough FEV1 (Forced expiratory volume in 1 second) at Week 24 (BFF MDI versus FF MDI)|at Week 24|mITT|||Liter||95% Confidence Interval|Least Squares Mean
2553426|NCT02776644|Primary|Number of Participants Who Received Antihypertensive Medication From Baseline to Month 1|To calculate number of patient receiving antihypertensive prescriptions at Month 1 for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.|Baseline (at the beginning of 11 year observation period) up to Month 1|All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2553427|NCT02776644|Primary|Number of Participants Who Received Antihypertensive Medication at Baseline|To calculate number of patient receiving antihypertensive prescriptions at baseline for each TKI users and classify the patterns of changes into unchanged, switched, increased and decreased. Shifting to other class(es) of antihypertensive agents without changes in counts of antihypertensive medication is defined as being switched.|Baseline (at the beginning of 11 year observation period)|All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2553428|NCT02776644|Primary|Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 12|Changes in the prescription patterns of antihypertensive medication were categorized as: 1) Unchanged: no change in the count/number of capsules or class(es) of the antihypertensive medication at Month 12 as compared to the time of first dose, 2) Increased: increase in counts/number of capsules of the ongoing class(es) of the antihypertensive medication at Month 12 as compared to the time of first dose, 3) Decreased: Decrease in the counts/number of capsules of ongoing class(es) of antihypertensive medication at Month 12 as compared to the time of first dose, 4) Switched: shifted to other class(es) of antihypertensive medication without changes in counts of antihypertensive medication at Month 12 as compared to the time of first dose. The number of participants with change in prescription patterns based on the specified categories is reported.|the first dose of the medication, Month 12|All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2553429|NCT02776644|Primary|Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 6|Changes in the prescription patterns of antihypertensive medication were categorized as: 1) Unchanged: no change in the count/number of capsules or class(es) of the antihypertensive medication at Month 6 as compared to the time of first dose, 2) Increased: increase in counts/number of capsules of the ongoing class(es) of the antihypertensive medication at Month 6 as compared to the time of first dose, 3) Decreased: Decrease in the counts/number of capsules of ongoing class(es) of antihypertensive medication at Month 6 as compared to the time of first dose, 4) Switched: shifted to other class(es) of antihypertensive medication without changes in counts of antihypertensive medication at Month 6 as compared to the time of first dose. The number of participants with change in prescription patterns based on the specified categories is reported.|the first dose of the drug, Month 6|All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2553430|NCT02776644|Primary|Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 3|Changes in the prescription patterns of antihypertensive medication were categorized as: 1) Unchanged: no change in the count/number of capsules or class(es) of the antihypertensive medication at Month 3 as compared to the time of first dose, 2) Increased: increase in counts/number of capsules of the ongoing class(es) of the antihypertensive medication at Month 3 as compared to the time of first dose, 3) Decreased: Decrease in the counts/number of capsules of ongoing class(es) of antihypertensive medication at Month 3 as compared to the time of first dose, 4) Switched: shifted to other class(es) of antihypertensive medication without changes in counts of antihypertensive medication at Month 3 as compared to the time of first dose. The number of participants with change in prescription patterns based on the specified categories is reported.|time of first dose of the drug, Month 3|All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2553431|NCT02776644|Primary|Number of Participants With Changes in Prescription Patterns of Antihypertensive Medication From the Time of First Dose of Drug at Month 1|Changes in the prescription patterns of antihypertensive medication were categorized as: 1) Unchanged: no change in the count/number of capsules or class(es) of the antihypertensive medication at Month 1 as compared to the time of first dose, 2) Increased: increase in counts/number of capsules of the ongoing class(es) of the antihypertensive medication at Month 1 as compared to the time of first dose, 3) Decreased: Decrease in the counts/number of capsules of ongoing class(es) of antihypertensive medication at Month 1 as compared to the time of first dose, 4) Switched: shifted to other class(es) of antihypertensive medication without changes in counts of antihypertensive medication at Month 1 as compared to the time of first dose. The number of participants with change in prescription patterns based on the specified categories is reported.|time of first dose of the drug, Month 1|All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Here, Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2553432|NCT02776644|Primary|Overall Survival|Overall survival of participants was defined as time (in days) between date of prescribing treatment (Sunitinib or Pazopanib) till date of death.|from the time of first prescription of Sunitinib or Pazopanib till date of death (during the observation period of 11 years)|All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib).|||days||95% Confidence Interval|Median
2553433|NCT02776644|Primary|Overall Renal Cell Carcinoma (RCC) Related Direct Medical Cost From the First Dose of the Sunitinib and Pazopanib to the End of Observation Period|Direct medical costs include the cost of the Sunitinib or Pazopanib and all follow-up costs for other medication and health care interventions in ambulatory, inpatient, and nursing care. All specialist and general practitioner care, including emergency care, as well as rehabilitation and physiotherapy.|From first dose of drug to the end of observation period (up to 11 years)|All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.|||new Taiwan dollars|||Number
2553434|NCT02776644|Primary|Overall Renal Cell Carcinoma (RCC) Related Direct Medical Cost From the Diagnosis Date to the First Dose of Sunitinib and Pazopanib|Direct medical costs include the cost of the Sunitinib or Pazopanib and all follow-up costs for other medication and health care interventions in ambulatory, inpatient, and nursing care. All specialist and general practitioner care, including emergency care, as well as rehabilitation and physiotherapy.|from the time of disease diagnosis till the first dose of Sunitinib and Pazopanib|All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib). Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.|||new Taiwan dollars|||Number
2553435|NCT02776644|Primary|Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From the Time of Start of Treatment Up to Month 12|The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from the time of start of treatment to Month 12 were reported here.|from the time of start of treatment up to Month 12|All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib).|||capsules||Standard Deviation|Mean
2553436|NCT02776644|Primary|Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 9 to Month 12|The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from Month 9 (after the start of treatment) to Month 12 were reported here.|Month 9 up to Month 12|All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib).|||capsules||Standard Deviation|Mean
2553437|NCT02776644|Primary|Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 6 to Month 9|The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from Month 6 (after the start of treatment) to Month 9 were reported here.|Month 6 up to Month 9|All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib).|||capsules||Standard Deviation|Mean
2553438|NCT02776644|Primary|Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From Month 3 to Month 6|The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from Month 3 (after the start of treatment) to Month 6 were reported here.|Month 3 up to Month 6|All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib).|||capsules||Standard Deviation|Mean
2553439|NCT02776644|Primary|Cumulative Number of Capsules of Sunitinib and Pazopanib Administered From the Time of Start of Treatment Up to Month 3|The cumulative number of Sunitinib and Pazopanib capsules which were given to the participants from the time of start of treatment up to Month 3 were reported here.|from the time of start of treatment up to Month 3|All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib).|||capsules||Standard Deviation|Mean
2553440|NCT02776644|Primary|Duration of Sunitinib and Pazopanib Treatment in Participants|Treatment durations (in days) of Sunitinib and Pazopanib were calculated from the date of the first prescription to the last dose of Sunitinib and Pazopanib during the 11 year observation period.|during the observation period of 11 years|All Taiwanese participants diagnosed with metastatic RCC during the time period of January 2004 to December 2015 and received treatment (Sunitinib or Pazopanib).|||days||Full Range|Median
2553441|NCT02776033|Secondary|Actual PLSS Scores in the Index Psoriatic Lesion Following Administration of GSK2982772|Two plaques were selected one for clinical assessment (index plaque) and one for biopsy. Each lesion was evaluated for 3 components: erythema, induration, and scaling. Each component was given a score using a scale ranging from 0 (no symptom) to 4 (very marked) with increasing score reflecting increased lesion severity. The PLSS is the sum of the erythema, scaling and plaque thickness scores. The total PLSS score ranged from 0 (no symptom) to 12 (very marked). Each lesion must have a PLSS score of >=5. Due to major Baseline imbalances in psoriasis Baseline characteristics between the BID and TID groups, placebo BID and placebo TID arms were reported separately for all efficacy analyses.|Days 1, 15, 29, 43, 57, 71 and 85|Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).|||Scores on a scale||Standard Deviation|Mean
2553442|NCT02776033|Secondary|Percentage Change From Baseline Psoriatic Lesion Severity Sum (PLSS) Scores in the Index Lesion Following Administration of GSK2982772|Two plaques were selected, one for clinical assessment (index plaque) and one for biopsy. Each lesion was evaluated for 3 components: erythema, induration, and scaling. Each component was given a score using a scale ranging from 0 (no symptom) to 4 (very marked) with increasing score reflecting increased lesion severity. The PLSS is the sum of the erythema, scaling and plaque thickness scores. The total PLSS score ranged from 0 (no symptom) to 12 (very marked). Each lesion must have a PLSS score of >=5. Baseline is defined as the latest pre-dose assessment. Percentage change from Baseline was determined from the back-calculation of the log ratio to Baseline. Due to major Baseline imbalances in psoriasis Baseline characteristics between the BID and TID groups, placebo BID and placebo TID arms were reported separately for all efficacy analyses.|Baseline (Pre-dose on Day 1) and Days 15, 29, 43, 57, 71, 85|Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).|||Percentage change||Standard Deviation|Mean
2553533|NCT02774681|Secondary|Time to CNS Progression|Time to CNS progression will be defined as the time from treatment initiation to documented disease progression (modified RANO-BM criteria) in the CNS.|Up to 3 years|Data not collected. Not sufficient patients enrolled for statistical analysis due to study closing to accrual before the accrual goal was met.||||||
2553443|NCT02776033|Secondary|Messenger Ribonucleic Acid (mRNA) Expression of Inflammatory Gene Transcripts in Psoriatic Lesional Biopsies Following Administration of GSK2982772|A target lesion for biopsy was identified on the trunk or extremities at indicated time points. mRNA expression of inflammatory markers and tissue healing were assessed. Data has been presented for inflammatory gene transcripts including interferon gamma, interleukin 10, interleukin 17A, interleukin 21, interleukin 22, interleukin 23 subunit alpha, interleukin 4 and tumor necrosis factor. Due to major Baseline imbalances in psoriasis Baseline characteristics between the BID and TID groups, placebo BID and placebo TID arms were reported separately for all biomarker analyses.|Day 1 and Day 43|Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).|||Copies per 25 nanogram RNA||Geometric Coefficient of Variation|Geometric Mean
2553444|NCT02776033|Secondary|Number of Participants With Changes in Keratin 16 (K16) Histopathological Scoring in Psoriatic Lesional Biopsies|A target lesion for biopsy was identified on the trunk or extremities at indicated time points. The manual cell counting performed on stained tissue section was referred as histopathological scoring of psoriatic lesions. Histologic assessment included measurement of K16 as keratin expression. Baseline is defined as the latest pre-dose assessment. Results for K16 were categorized as, negative to positive, no change and positive to negative at Day 43. Due to major Baseline imbalances in psoriasis Baseline characteristics between the BID and TID groups, placebo BID and placebo TID arms were reported separately for all biomarker analyses.|Baseline (Pre-dose on Day 1) and Day 43|Safety Population|||Participants|||Count of Participants
2553445|NCT02776033|Secondary|Adjusted Mean Percentage Change in Histopathological Scoring of Psoriatic Lesional Biopsy: Epidermis Thickness|A target lesion for biopsy was identified on the trunk or extremities at indicated time points. The manual cell counting performed on stained tissue section was referred as histopathological scoring of psoriatic lesions. Histologic assessment included measurement of epidermis thickness. Baseline is defined as the latest pre-dose assessment. Percentage change from Baseline was determined from the back-calculation of the log ratio to Baseline. Due to major Baseline imbalances in psoriasis Baseline characteristics between the BID and TID groups, placebo BID and placebo TID arms were reported separately for all biomarker analyses.|Baseline (Pre-dose on Day 1) and Day 43|Safety Population. Only those participants with data available at specified time point were analyzed.|||Percent change||Geometric Coefficient of Variation|Geometric Mean
2553446|NCT02776033|Secondary|Adjusted Mean Percentage Change in Histopathological Scoring of Psoriatic Lesional Biopsy Following Administration of GSK2982772|A target lesion for biopsy was identified on the trunk or extremities at indicated time points. The manual cell counting performed on stained tissue section was referred as histopathological scoring of psoriatic lesions. Histologic assessment included measurement of Cluster of differentiation 11 (CD11+), CD161+, CD3+ and Elastase. Baseline is defined as the latest pre-dose assessment. Percentage change from Baseline was determined from the back-calculation of the log ratio to Baseline. Data for all the listed biomarkers from skin biopsy has been presented for two skin types; dermis and epidermis at Day 43. Due to major Baseline imbalances in psoriasis Baseline characteristics between the BID and TID groups, placebo BID and placebo TID arms were reported separately for all biomarker analyses. NA indicates that data was not available as geometric coefficient of variation could not be calculated for single participant.|Baseline (Pre-dose on Day 1) and Day 43|Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).|||Percent change||Geometric Coefficient of Variation|Geometric Mean
2553447|NCT02776033|Secondary|Post-dose Plasma Concentrations of GSK2982772 on Days 1 and 43|Blood samples were collected for pharmacokinetic analysis of GSK2982772 following 60 mg BID and 60 mg TID dose at indicated time points. The pharmacokinetic analysis was performed using non-compartmental methods.|1, 2, 4 and 6 Hours Post-dose on Days 1 and 43|Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).|||Nanograms per milliliter||Standard Deviation|Mean
2553448|NCT02776033|Secondary|Plasma Concentrations of GSK2982772 at Days 43 and 85|Blood samples were collected for pharmacokinetic analysis of GSK2982772 following 60 mg BID and 60 mg TID dose at indicated time points. The pharmacokinetic analysis was performed using non-compartmental methods. The analysis was based on Pharmacokinetic Population which comprised of participants in the 'Safety' Population for whom a pharmacokinetic sample was obtained and analyzed.|Day 43 (Pre-dose) and Day 85|Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).|||Nanograms per milliliter||Standard Deviation|Mean
2553449|NCT02776033|Primary|Number of Participants With Any Time Post-Baseline Results for Electrocardiogram Findings|Single 12-lead electrocardiograms were obtained at indicated time points during the study using an electrocardiogram machine that automatically calculates the heart rate and measures PR, QRS, QT, QT interval corrected for heart rate (QTc) using Bazett's formula (QTcB) intervals and QTc using Fridericia's formula (QTcF). The abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Baseline is defined as the latest pre-dose assessment. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. The number of participants with normal and abnormal electrocardiogram findings at any time post-Baseline visit has been presented.|Up to Day 116|Safety Population|||Participants|||Count of Participants
2553450|NCT02776033|Primary|Change From Baseline in Body Temperature|Body temperature was measured at indicated time points in supine or semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment. Change from Baseline is defined as any post-dose visit value minus Baseline value.|Baseline (Pre-dose on Day 1), Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85 and Follow-up (Day 116)|Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).|||Celsius||Standard Deviation|Mean
2553451|NCT02776033|Primary|Change From Baseline in Respiratory Rate|Respiratory rate was measured at indicated time points in supine or semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment. Change from Baseline is defined as any post-dose visit value minus Baseline value.|Baseline (Pre-dose on Day 1), Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85 and Follow-up (Day 116)|Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).|||Breaths per minute||Standard Deviation|Mean
2553453|NCT02776033|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure was measured at indicated time points in supine or semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment. Change from Baseline is defined as any post-dose visit value minus Baseline value.|Baseline (Pre-dose on Day 1), Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85 and Follow-up (Day 116)|Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).|||Millimeter of mercury||Standard Deviation|Mean
2553454|NCT02776033|Primary|Change From Baseline in Urine Specific Gravity|Urine samples were collected to analyze specific gravity of urine. Specific gravity, is a measure of urine concentration and is measured using a chemical test. Specific gravity measurements provide a comparison of the amount of substances dissolved in urine as compared to pure water. If there were no solutes present, the specific gravity of urine would be 1.000 the same as pure water. Specific gravity between 1.002 and 1.035 could be considered as normal. Baseline is defined as the latest pre-dose assessment. Change from Baseline is defined as any post-dose visit value minus Baseline value.|Baseline (Pre-dose on Day 1), Day 8, Day 15, Day 43, Day 85 and Follow-up (Day 116)|Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).|||Ratio||Standard Deviation|Mean
2553455|NCT02776033|Primary|Change From Baseline in Urine Potential of Hydrogen (pH)|Urine samples were collected for measurement of urine pH at indicated time points. pH is a measure of hydrogen ion concentration and used to determine the acidity or alkalinity of urine. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Baseline is defined as the latest pre-dose assessment. Change from Baseline is defined as any post-dose visit value minus Baseline value.|Baseline (Pre-dose on Day 1), Day 8, Day 15, Day 43, Day 85 and Follow-up (Day 116)|Safety Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).|||Potential of hydrogen (pH)||Standard Deviation|Mean
2553456|NCT02776033|Primary|Number of Participants With Worst-case Post-Baseline Hematology Results by PCI Criteria|"Blood samples were collected for analysis of hematology parameters. Clinical concern ranges were >0.54 calculated as proportion of red blood cells in blood for Hematocrit, >180 grams per liter for Hemoglobin, <0.8 x10^9 cells per liter for Lymphocytes, <1.5 x10^9 cells per liter for Neutrophil count, <100 or >550 x10^9 cells per liter for Platelet count and <3 or >20 x10^9 cells per liter White Blood Cell count. Participants were counted in the worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became normal, are recorded in the To Normal or No Change category. Participants were counted twice if they had values that changed 'To Low' and 'To High'. Baseline is defined as the latest pre-dose assessment."|Up to Day 116|Safety Population. Only those hematology parameters with data available per PCI criteria have been presented.|||Participants|||Count of Participants
2553457|NCT02776033|Primary|Number of Participants With Worst-case Post-Baseline Clinical Chemistry Results by Potential Clinical Importance (PCI) Criteria|"Blood samples were collected for analysis of clinical chemistry parameters. Clinical concern ranges were >=2x Upper Limit of Normal (ULN) units per liter (U/L) for alanine aminotransferase (ALT), <30 millimoles per liter (mmol/L) for albumin, >=2x ULN U/L for alkaline phosphatase, >=2x ULN U/L for aspartate aminotransferase (AST), <2 or >2.75 mmol/L for Calcium, >44.2 mmol/L for Creatinine, <3 or >9 mmol/L for Glucose, <3 or>5.5 mmol/L for Potassium, <130 or >150 mmol/L for Sodium, and >=1.5xULN micromoles per liter for total bilirubin. Participants were counted in worst case category that their value changes to (Low, Normal or High), unless there is no change in their category. Participants whose value category was unchanged (example given [e.g.], High to High), or whose value became normal, were recorded in To Normal or No Change category. Participants were counted twice if they had values that changed 'To Low' and 'To High', Baseline is defined as the latest pre-dose assessment."|Up to Day 116|Safety Population. Only those clinical chemistry parameters with data available per PCI criteria have been presented.|||Participants|||Count of Participants
2553458|NCT02776033|Primary|Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment. Safety Population comprised of all participants who received at least one dose of study treatment.|Up to Day 116|Safety Population|||Participants|||Count of Participants
2553459|NCT02775916|Secondary|Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS) After 12 Weeks of Treatment Day 85|"A reduction from baseline (or, a negative change from baseline) in patient global VAS assessment score indicates improvement in patients.~The visual analogue scale used is a 100 mm VAS ranging from no disease (0 mm) to maximal disease activity (100 mm)."|Baseline and 12 weeks|PD analysis set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the PD analysis set|||total score on a scale||Standard Error|Least Squares Mean
2553460|NCT02775916|Secondary|Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (Physician VAS) After 12 Weeks of Treatment Day 85|"A reduction from baseline (i.e., a negative change from baseline) in physician global VAS assessment score indicates improvement in patients. The visual analogue scale used is a 100 mm VAS ranging from no disease (0 mm) to maximal disease activity (100 mm)."|Baseline and 12 weeks (Day 85)|PD analysis set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the PD analysis set|||total score on a scale||Standard Error|Least Squares Mean
2553497|NCT02775240|Primary|Terminal Half-life (t1/2) of Digoxin|Terminal half-life (t1/2) is the time in hours required for the concentration of the drug to reach half of its original value.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Hour (h)||95% Confidence Interval|Geometric Mean
2553461|NCT02775916|Secondary|Change in Baseline in Multidimensional Fatigue Inventory (MFI) After 12 Weeks of Treatment (Day 85)|"The Multidimensional Fatigue Inventory (MFI) is a patient self-reported outcome measure (questionnaires) to assess fatigue covering the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Each dimension has a possible range from 4-20. The reported total score has a range from 20-100.~The reported total score has a range from 20-100, higher scores are associated with greater fatigue."|Baseline and 12 weeks (Day 85)|PD analysis set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the PD analysis set|||total score on scale||Standard Error|Least Squares Mean
2553462|NCT02775916|Secondary|Change From Baseline in the Short Form (36) Health Survey (SF-36) After 12 Weeks of Treatment Day 85|The SF-36 is a 36-item, patient self-reported outcome measure (questionnaires) of patient health. The outcome of the questionnaires in eight scales results in two summary scores, physical component and mental component, both ranging from 0 - 100. An increase from baseline in either component summary score indicates reduced disease burden.|Baseline and 12 weeks (Day 85)|PD analysis set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the PD analysis set|||total score on a scale||Standard Error|Least Squares Mean
2553463|NCT02775916|Secondary|Change From Baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) After 12 Weeks of Treatment Day 85|The ESSDAI is an established disease outcome measure for Sjögren's syndrome. The instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score. A reduction from baseline (i.e., a negative change from baseline) in the ESSDAI score is indicative of improvement in a patient.). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. An overall score is then calculated as the sum of all individual weighted domain scores. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity).|Baseline and 12 weeks (Day 85)|PD analysis set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the PD analysis set|||total score on scale||Standard Error|Least Squares Mean
2553464|NCT02775916|Primary|Change From Baseline in the EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI) After 12 Weeks of Treatment Day 85|The ESSPRI is an established disease outcome measure for Sjögren's syndrome. The ESSPRI is a patient-reported, subjective symptom index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10.|Baseline and 12 weeks (Day 85)|PD analysis set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the PD analysis set|||total score on scale||Standard Deviation|Mean
2553465|NCT02775916|Primary|Number of Participants With Primary Sjögren's Syndrome With Adverse Events and Death up to Day 85|Safety and tolerability of CDZ173 in patients with primary Sjögren's syndrome up to End of Treatment Day 85|up to Day 85|Safety Analysis Set - All randomized patients in the CDZ173 group (20 patients) and placebo group (10 patients) were included in the safety analysis set|||count of participants|||Number
2553466|NCT02775864|Secondary|Death|Participants who died|One year||||Participants|||Count of Participants
2553467|NCT02775864|Secondary|Emergency Department Visit for Mental Health Reason|Number of Participants with an Emergency Department visit for mental health reason|One year||||Participants|||Count of Participants
2553468|NCT02775864|Primary|Psychiatric Hospitalization|Number of participants hospitalized for a mental health reason|One year||||Participants|||Count of Participants
2553469|NCT02775617|Secondary|Antimicrobial Resistance in Culture Isolates|The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms|12 Months|This analysis was restricted to the subset of patients in whom S.pyogenes was isolated on a swab|||Number of swabs|||Number
2553470|NCT02775617|Secondary|Group A Streptococcus at 12 Months|Change in the percentage of swab samples from which S. pyogenes is cultured between baseline and 12 month follow-up in the two arms|12 Months|"Samples were collected at twelve months from individuals with clinical impetigo and cultured for both pyogenic streptococci and S.aureus.~This analysis is therefore restricted to the subset of patients who had impetigo from which a swab was collected"|||Change in number swabs with S.pyogenes|||Number
2553471|NCT02775617|Primary|Impetigo Prevalence at 12 Months|Change in prevalence of impetigo between baseline and 12-months|Baseline and 12 months|"At the baseline survey 653 individuals were seen in the Parallel arm and 638 in the sequential treatment arm.~At the 12 month survey 605 individuals were seen in the Parallel arm and 478 in the sequential treatment arm"|||Cases of impetigo|||Number
2553472|NCT02775435|Secondary|Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)|The number of participants who discontinued study treatment due to an AE is presented.|Up to approximately 19 months (Database cutoff date of 03-Apr-2018)|The Safety population consisted of all participants who received ≥1 dose of study treatment.|||Participants|||Count of Participants
2553473|NCT02775435|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE is presented.|Up to approximately 19 months (Database cutoff date of 03-Apr-2018)|The Safety population consisted of all participants who received ≥1 dose of study treatment.|||Participants|||Count of Participants
2553508|NCT02775240|Primary|Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Dextromethorphan|AUC0-infinity is the area under the plasma concentration versus time curve extrapolated to infinity, calculated using the observed value of the last non-zero concentration.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Nanogram*hour per milliliter (ng*h/mL)|||Number
2553474|NCT02775435|Secondary|Duration of Response (DOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|For participants who demonstrated a confirmed response (Complete Response [CR]: Disappearance of all target lesions or Partial Response [PR]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression as assessed by RECIST 1.1 or death. DOR as assessed by blinded independent central review per RECIST 1.1 is presented.|Up to approximately 19 months (Database cutoff date of 03-Apr-2018)|The Intent-To-Treat population consisted of all randomized participants, regardless of whether or not they received study treatment, who demonstrated a confirmed response (CR or PR). Participants were included in the treatment arm to which they were randomized.|||Months||Full Range|Median
2553475|NCT02775435|Secondary|Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by RECIST 1.1. ORR as assessed by blinded independent central review per RECIST 1.1 is presented.|Up to approximately 19 months (Database cutoff date of 03-Apr-2018)|The Intent-To-Treat population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment arm to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
2553476|NCT02775435|Primary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. OS is presented.|Up to approximately 19 months (Database cutoff date of 03-Apr-2018)|The Intent-To-Treat population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment arm to which they were randomized.|||Months||95% Confidence Interval|Median
2553477|NCT02775435|Primary|Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of ≥1 new lesions was also considered PD. PFS as assessed by blinded independent central review per RECIST 1.1 is presented.|Up to approximately 19 months (Database cutoff date of 03-Apr-2018)|The Intent-To-Treat population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment arm to which they were randomized.|||Months||95% Confidence Interval|Median
2553478|NCT02775344|Secondary|Duration of Hospital Stay|The total duration of hospital stay was recorded.|Postoperative up to 6 weeks|Chief surgeons of the operation were required to find in a questionnaire immediate postoperatively which include GOALS score assessment, any side effects experienced and their preferences for 2D/ 3D laparoscopy for the particular operation. As the assessment is on case to case basis, thus individual surgeons not recruited.|||Days||Standard Deviation|Mean
2553479|NCT02775344|Secondary|Total Blood Loss During Operation|The total amount of blood loss during operation was recorded.|during the operation, up to 120 minutes|Chief surgeons of the operation were required to find in a questionnaire immediate postoperatively which include GOALS score assessment, any side effects experienced and their preferences for 2D/ 3D laparoscopy for the particular operation. As the assessment is on case to case basis, thus individual surgeons not recruited.|||ml||Standard Deviation|Mean
2553480|NCT02775344|Secondary|Need for Change of Instrument|The surgeons are allowed to switch from 3D laparoscopy to tranditional 2D laparoscopy if deemed necessary by the surgeons. The reason for switch of instrument will be recorded as well.|during the operation, up to 120 minutes||||Participants|||Count of Participants
2553481|NCT02775344|Secondary|Preference of Surgeons|Surgeons need to indicate their preference of 3D or 2D laparoscopy after the surgery.|during the operation, up to 120 minutes|Chief surgeons of the operation were required to find in a questionnaire immediate postoperatively which include GOALS score assessment, any side effects experienced and their preferences for 2D/ 3D laparoscopy for the particular operation. As the assessment is on case to case basis, thus individual surgeons not recruited.|||Participants|||Count of Participants
2553482|NCT02775344|Secondary|Number of Surgeons Encountered Side Effects|Dizziness, nausea and ocular fatique are common side effects of 3D laparoscopy. The number of surgeons experienced discomfort will be reported and any additional discomfort will be recorded.|during the operation, up to 120 minutes|Chief surgeons of the operation were required to find in a questionnaire immediate postoperatively which include GOALS score assessment, any side effects experienced and their preferences for 2D/ 3D laparoscopy for the particular operation. As the assessment is on case to case basis, thus individual surgeons not recruited.|||Participants|||Count of Participants
2553483|NCT02775344|Primary|Global Rating Scale Component of the Intraoperative Assessment Tool (GOALS) Score|Surgeons are required to fill in a questionnaire using GOALS. It involved seven aspects - depth perception, bimanual dexterity, efficiency, tissue handling, autonomy, sharpness and image resolution. Each aspects scored 0 to 5 with higher the value, better the performance. The sum of the 7 aspects were used in comparison between groups with a maximum score of 35.|During the operation, up to 120 minutes|Chief surgeons of the operation were required to find in a questionnaire immediate postoperatively which include GOALS score assessment, any side effects experienced and their preferences for 2D/ 3D laparoscopy for the particular operation. As the assessment is on case to case basis, thus individual surgeons not recruited.|||score on a scale||Standard Deviation|Mean
2553484|NCT02775344|Primary|The Duration of Laparoscopic Ovarian Cystectomy|The duration of laparoscopic ovarian cystectomy will be recorded. It is defined as from insertion of primary port insertion till completion of performance of ovarian cystectomy. The time required for specimen retrieval will not be included.|duration of operation, up to 120 minutes||||minutes||Standard Deviation|Mean
2553485|NCT02775240|Secondary|Number of Participants With Clinically Significant Changes Reported as TEAE in Physical Examination, Vital Signs, 12-lead ECGs, Hematology, Blood Chemistry and Urinalysis|Clinical significance of the changes observed in the safety parameters to be reported as TEAE was interpreted by the investigator.|Baseline up to Day 16|Safety set consisted of all participants who were administered at least 1 dose of investigational product (maribavir, digoxin, or dextromethorphan) and had at least 1 post-dose safety assessment.|||Participants|||Count of Participants
2553486|NCT02775240|Secondary|Number of Participants With Study-related Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs)|An AE was any untoward medical occurrence in a participant administered an investigational product (IP) and that did not necessarily have a causal relationship with this treatment. AE was considered to be study-related if there was any valid reason, even if undetermined or untested, for suspecting a possible cause-and-effect relationship between the IP and the occurrence of the AE. An AE was considered a TEAE if it had a start date on or after the first dose of IP or if it had a start date before the date of the first dose of IP, but increased in intensity on or after the date of the first dose of IP. A serious adverse event (SAE) was any untoward medical occurrence (related either to the test product or to the other IP or not) that at any dose resulted in death; was life-threatening; required or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; was a congenital abnormality/birth defect; was an important medical event.|From start of study drug administration up to follow-up (up to 25 days)|Safety set consisted of all participants who were administered at least 1 dose of the test product (maribavir) or to the other investigational products (digoxin and dextrometorphan) and had at least 1 post-dose safety assessment.|||Participants|||Count of Participants
2553487|NCT02775240|Primary|Pre-dose Concentration (C0) of Maribavir|C0 is the lowest concentration reached by a drug before the next dose is administered.|Pre-dose on Day 13|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
2553488|NCT02775240|Primary|Volume of Distribution Divided by the Fraction of Dose Absorbed (Vz/F) of Dextromethorphan|Vz/F is the volume of distribution associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Liter (L)|||Number
2553489|NCT02775240|Primary|Volume of Distribution Divided by the Fraction of Dose Absorbed (Vz/F) of Digoxin|Vz/F is the volume of distribution associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Liter (L)||95% Confidence Interval|Geometric Mean
2553490|NCT02775240|Primary|Concentration at the End of Dosing Interval (Ctau) of Maribavir|Ctau is the concentration of maribavir at the end of the dosing interval.|Pre-dose, 0.25,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose on Day 13|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
2553491|NCT02775240|Primary|Apparent Oral Clearance (CL/F) of Maribavir|CL/F is equal to dose/AUCtau (dose divided by area under the curve from time 0 to the end of the dosing interval at steady state [AUCtau])|Pre-dose, 0.25,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose on Day 13|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Liter per hour (L/h)||95% Confidence Interval|Geometric Mean
2553492|NCT02775240|Primary|Apparent Oral Clearance (CL/F) of Dextromethorphan|CL/F is equal to dose/AUC0-infinity (dose divided by area under the plasma concentration versus time curve extrapolated to infinity [AUC0-infinity])|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Liter per hour (L/h)|||Number
2553493|NCT02775240|Primary|Apparent Oral Clearance (CL/F) of Digoxin|CL/F is equal to dose/AUC0-infinity (dose divided by area under the plasma concentration versus time curve extrapolated to infinity [AUC0-infinity]).|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Liter per hour (L/h)||95% Confidence Interval|Geometric Mean
2553494|NCT02775240|Primary|Terminal Half-life (t1/2) of Maribavir|Terminal half-life (t1/2) is the time in hours required for the concentration of the drug to reach half of its original value.|Pre-dose, 0.25,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose on Day 13|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Hour (h)||95% Confidence Interval|Geometric Mean
2553495|NCT02775240|Primary|Terminal Half-life (t1/2) of Dextrorphan|Terminal half-life (t1/2) is the time in hours required for the concentration of the drug to reach half of its original value.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Hour (h)||95% Confidence Interval|Geometric Mean
2553496|NCT02775240|Primary|Terminal Half-life (t1/2) of Dextromethorphan|Terminal half-life (t1/2) is the time in hours required for the concentration of the drug to reach half of its original value.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Hour (h)|||Number
2553522|NCT02774798|Secondary|Squeeze Opening Elastance|the resistance of the anal canal to stretch during voluntary contraction|at specific time point of measurement up to 1 hour||||cmH20/mm2||Standard Deviation|Mean
2553498|NCT02775240|Primary|First-order Rate Constant (Lambda z) Associated With the Terminal (Log-linear) Portion of the Curve of Dextrorphan|Lambda z is the first-order rate constant associated with the terminal (log-linear) portion of the plasma concentration versus time curve, determined as the negative slope of the terminal log-linear phase of the curve.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Per hour (/h)||95% Confidence Interval|Geometric Mean
2553499|NCT02775240|Primary|First-order Rate Constant (Lambda z) Associated With the Terminal (Log-linear) Portion of the Curve of Dextromethorphan|Lambda z is the first-order rate constant associated with the terminal (log-linear) portion of the plasma concentration versus time curve, determined as the negative slope of the terminal log-linear phase of the curve.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Per hour (/h)|||Number
2553500|NCT02775240|Primary|First-order Rate Constant (Lambda z) Associated With the Terminal (Log-linear) Portion of the Curve of Digoxin|Lambda z is the first-order rate constant associated with the terminal (log-linear) portion of the plasma concentration versus time curve, determined as the negative slope of the terminal log-linear phase of the curve.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Per hour (/h)||95% Confidence Interval|Geometric Mean
2553501|NCT02775240|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the End of the Dosing Interval at Steady-State (AUCtau) of Maribavir|AUCtau is the area under the plasma concentration versus time curve from the time zero to the end of the dosing interval at steady-state.|Pre-dose, 0.25,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose on Day 13|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Microgram*hour per milliliter (mcg*h/mL)||95% Confidence Interval|Geometric Mean
2553502|NCT02775240|Primary|Parent/Metabolite Ratio of Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) for Dextromethorphan Over AUC0-infinity for Dextrorphan (AUC0-infinity Parent/Metabolite Ratio)|AUC0-infinity parent/metabolite ratio is the ratio of AUC0-infinity for dextromethorphan over AUC0-infinity for dextrorphan.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Ratio of AUC0-infinity|||Number
2553503|NCT02775240|Primary|Parent/Metabolite Ratio of Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) for Dextromethorphan Over AUClast for Dextrorphan (AUClast Parent/Metabolite Ratio)|AUClast parent/metabolite ratio is the ratio of AUClast for dextromethorphan over AUClast for dextrorphan.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Ratio of AUClast||95% Confidence Interval|Geometric Mean
2553504|NCT02775240|Primary|Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Dextrorphan|AUClast is the area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Nanogram*hour per milliliter (ng*h/mL)||95% Confidence Interval|Geometric Mean
2553505|NCT02775240|Primary|Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Dextromethorphan|AUClast is the area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Nanogram*hour per milliliter (ng*h/mL)||95% Confidence Interval|Geometric Mean
2553506|NCT02775240|Primary|Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Digoxin|AUClast is the area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Nanogram*hour per milliliter (ng*h/mL)||95% Confidence Interval|Geometric Mean
2553507|NCT02775240|Primary|Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Dextrorphan|AUC0-infinity is the area under the plasma concentration versus time curve extrapolated to infinity, calculated using the observed value of the last non-zero concentration.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Nanogram*hour per milliliter (ng*h/mL)||95% Confidence Interval|Geometric Mean
2553509|NCT02775240|Primary|Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Digoxin|AUC0-infinity is the area under the plasma concentration versus time curve extrapolated to infinity, calculated using the observed value of the last non-zero concentration.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Nanogram*hour per milliliter (ng*h/mL)||95% Confidence Interval|Geometric Mean
2553510|NCT02775240|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Maribavir|Tmax is the time to reach the maximum observed drug concentration in plasma during a dosing interval.|Pre-dose, 0.25,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose on Day 13|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Hour (h)||Full Range|Median
2553511|NCT02775240|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Dextrorphan|Tmax is the time to reach the maximum observed drug concentration in plasma during a dosing interval.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Hour (h)||Full Range|Median
2553512|NCT02775240|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Dextromethorphan|Tmax is the time to reach the maximum observed drug concentration in plasma during a dosing interval.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Hour (h)||Full Range|Median
2553513|NCT02775240|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Digoxin|Tmax is the time to reach the maximum observed drug concentration in plasma during a dosing interval.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Hour (h)||Full Range|Median
2553514|NCT02775240|Primary|Maximum Observed Plasma Concentration (Cmax) of Maribavir|Cmax is the maximum observed plasma concentration of maribavir.|Pre-dose, 0.25,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose on Day 13|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
2553515|NCT02775240|Primary|Maximum Observed Plasma Concentration (Cmax) of Dextrorphan|Cmax is the maximum observed plasma concentration of dextrorphan, the metabolite of dextromethorphan.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Nanogram per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
2553516|NCT02775240|Primary|Maximum Observed Plasma Concentration (Cmax) of Dextromethorphan|Cmax is the maximum observed plasma concentration of dextromethorphan.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|PK set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Nanogram per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
2553517|NCT02775240|Primary|Maximum Observed Plasma Concentration (Cmax) of Digoxin|Cmax is the maximum observed plasma concentration of digoxin.|Pre-dose,0.25,0.5,1,1.5,2,3,4,5,6,8,12,24,48,72 hours post-dose on Day 1 for Treatment A and Day 13 for Treatment B|Pharmacokinetic (PK) set consisted of all participants who received at least 1 dose of investigational product and had evaluable PK data (defined as complete concentration-time profile to obtain meaningful estimates of PK parameters) available for 1 dose regimen.|||Nanogram per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
2553518|NCT02774941|Secondary|Number of Treatments Required to Achieve Mild Asthma Score - Discharge Criteria||Within emergency department visit time frame (no more than 12 hours)||||number of treatments||Inter-Quartile Range|Median
2553519|NCT02774941|Primary|Number of Subjects Hospitalized|The primary outcome measure is rate of hospitalization between the two treatment groups overall|Within emergency department visit time frame (no more than 12 hours)||||Participants|||Count of Participants
2553520|NCT02774850|Secondary|Time to the Initiation of the Next Chemotherapy Course|Time to next course of chemotherapy will be measured as the number of days from the three days after the completion chemotherapy in a given course until the first day of the next course.|The number of days from the three days after the completion chemotherapy in a given course until the first day of the next course|Patients in Induction II who were analyzed for the amount of time (in days) it took for them to start their next chemotherapy course.|||days||Standard Deviation|Mean
2553521|NCT02774850|Primary|Occurrence of Post-chemotherapy Bacteremia|Identification of bacteremia will begin three days after completion of a chemotherapy course and will continue until recovery of absolute neutrophil count (ANC > 200 uL), or until the start of the next course (for a very small number of patients who begin the next course of chemotherapy prior to count recovery). Bacteremia will be defined as a single positive blood culture for a bacterial pathogen (including Viridans group Streptococci). If the bacterium is an organism considered as a common commensal organism by the National Healthcare Safety Network, two separate positive blood cultures will be required for classification as bacteremia.|Identification of bacteremia will begin three days after completion of a chemotherapy course and will continue until recovery of absolute neutrophil count (ANC > 200 uL), or until the start of the next course.|Patients in study course Induction II analyzed for bacteremia for this course.|||Participants|||Count of Participants
2553534|NCT02774681|Secondary|Overall Response Rate (ORR)|"Evaluate systemic ORR defined as partial response or complete response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 where:~Complete Response = complete disappearance of all lesions Partial Response = At least 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters."|Up to 3 years|All patient data is shown. Patients that did not complete 2 cycles of treatment required for response are also included as there was no analysis of the data.|||participants|||Number
2553535|NCT02774681|Secondary|Progression Free Survival (PFS)|Determine the PFS in patients with HER2-positive breast cancer who have brain metastasis treated with palbociclib where PFS is defined as the time from treatment initiation to documented disease progression or death for any reason. Below shows the number of patient who discontinued treatment due to progression of disease.|Up to 3 years|Not sufficient patients enrolled for statistical analysis due to study closing to accrual before the accrual goal was met. Number of patients shown below is the number of patients that discontinued treatment due to progression.|||patients|||Number
2553536|NCT02774681|Secondary|Overall Survival (OS)|Evaluate OS in patients with HER2-positive breast cancer who have brain metastasis treated with palbociclib. OS is defined as the time from treatment initiation until death due to any cause. Number of patients remaining alive as of the last follow up date, is reported below.|Up to 3 years|one patient withdrew consent to be followed for survival|||participants alive|||Number
2553537|NCT02774681|Secondary|Incidence of Adverse Events|Determine the safety and tolerability of palbociclib in patients with HER2-positive breast cancer by evaluating number, frequency, and severity of adverse events using Common Terminology Criteria for Adverse Events version 4.03. The number of patients that experienced SAEs that were determined to be at least possibly related to study drug are reported below.|Up to 3 years|Data not collected for analysis|||participants|||Number
2553538|NCT02774681|Primary|Radiographic Response Rate (RRR) in the CNS in Patients With HER2-positive Breast Cancer Who Have Brain Metastasis Treated With Palbociclib|"Assess the Radiographic Response Rate (RRR) in the CNS by modified Response Assessment in Neuro-Oncology Criteria Brain Metastasis (modifiedRANO-BM). Maximum response prior to disease progression will be used. In General:~Complete Response : Disappearance of all lesions Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.~Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)"|Up to 3 years|Below table shows best response (Clinical and radiological) of all patients treated on study. Patients that did not complete 2 cycles of treatment required for evaluability for response rate objective are shown. No RRR was not calculated as the study did not met statistical analysis criteria due to study closing before total accrual was met.|||Participants|||Count of Participants
2553539|NCT02774616|Secondary|Rate of Appropriate Right Ventricular Pacing at the 3 Months Follow-up|The investigator is asked whether the pacing function of the Pleaxa lead in the right ventricle is appropriate|3 months|Patients in whom this endpoint was not evaluated did not attend the 3-months follow-up or the data were not recorded|||Participants|||Count of Participants
2553540|NCT02774616|Secondary|Rate of Appropriate Right Ventricular Sensing at 3-month Follow-up|The investigator is asked whether the sensing function of the Pleaxa lead in the right ventricle is appropriate|3 months|Patients in whom this endpoint was not evaluated did not attend the 3-months follow-up or the data were not recorded|||Participants|||Count of Participants
2553541|NCT02774616|Secondary|Percentage of Patients With Successful Fast Ventricular Arrhythmia Conversion by ATP One-shot at 6-month Follow-up|"Of all patients with spontaneous ventricular arrhythmia detected in the VF zone, and treated by ATP-one-shot, the percentage of patients with at least one successful termination will be determined"|6 months|Only 5 patients had spontaneous ventricular arrhythmia detected in the VF zone.|||Participants|||Count of Participants
2553542|NCT02774616|Primary|Plexa Related SADE-free Rate Through 6 Months|"This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the Plexa lead"|6 months|These are all patients who either had an endpoint or who reached 6 months of follow-up.|||Participants|||Count of Participants
2553543|NCT02774616|Primary|Ilivia Family Related SADE-free Rate Through 3 Months|This endpoint measures the percentage of patients without serious adverse device effect (SADE) related to the ICD device|3 months|These are all patients who either had a primary endpoint or who had reached 3 months of follow-up, or both.|||Participants|||Count of Participants
2553544|NCT02774343|Secondary|Cocaine Use as Assessed by Percentage of Self-reports That Indicate Cocaine Use|A modified Timeline Followback (TLFB) procedure was used to assess cocaine use. The mean percentage over all time points is reported in this outcome measure. Self-reports were collected once weekly.|Weeks 1-12||||percentage of self-reports||Standard Deviation|Mean
2553545|NCT02774343|Secondary|Cocaine Use as Assessed by Percentage of Urine Samples That Were Cocaine-positive|The mean percentage over all time points is reported in this outcome measure. Urine samples were collected once weekly.|Weeks 1-12||||percentage of urine samples||Standard Deviation|Mean
2553546|NCT02774343|Secondary|Feasibility - Tolerability as Assessed by Number of Participants With Serious Adverse Events||week 12||||Participants|||Count of Participants
2553547|NCT02774343|Secondary|Feasibility - Tolerability as Assessed by Number of Participants Reporting Side Effects||week 12||||Participants|||Count of Participants
2553548|NCT02774343|Secondary|Feasibility - Medication Compliance as Assessed by Percentage of Self-reports That Indicate Capsules Were Taken|A modified Timeline Followback (TLFB) procedure was used for self-reports. The percentage over all time points is reported in this outcome measure. Self-reports were collected once weekly.|weeks 1 - 12||||percentage of self-reports||Standard Error|Mean
2553549|NCT02774343|Secondary|Feasibility - Medication Compliance as Assessed by Percentage of Urine Samples That Were Riboflavin-Positive|Riboflavin was added to pill capsules as a marker of medication compliance. The percentage over all time points is reported in this outcome measure. Urine samples were collected once weekly.|weeks 1 - 12||||percentage of urine samples||Standard Error|Mean
2553551|NCT02774343|Primary|Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Cingulum)|DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index.|Baseline and Week 12|Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance.|||DTI Fractional Anisotropy (FA) value||Standard Deviation|Mean
2553552|NCT02774343|Primary|Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - External Capsule)|DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index.|Baseline and Week 12|Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance.|||DTI Fractional Anisotropy (FA) value||Standard Deviation|Mean
2553553|NCT02774343|Primary|Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Genu of Corpus Callosum)|DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index.|Baseline and Week 12|Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance.|||DTI Fractional Anisotropy (FA) value||Standard Deviation|Mean
2553554|NCT02774343|Primary|Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Splenium of Corpus Callosum)|DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index.|Baseline and Week 12|Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance.|||DTI Fractional Anisotropy (FA) value||Standard Deviation|Mean
2553555|NCT02774343|Primary|Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Anterior Thalamic Radiation)|DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index.|Baseline and Week 12|Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance.|||DTI Fractional Anisotropy (FA) value||Standard Deviation|Mean
2553556|NCT02774343|Primary|Brain White Matter (WM) Integrity as Assessed by Diffusion Tensor Imaging (DTI) Fractional Anisotropy (FA) Value (Region - Posterior Thalamic Radiation)|DTI scans were acquired on a Philips Integra 3T magnet. Fractional anisotropy (FA) is a summary measure of the integrity of white matter neurons that provides a dimensionless index of the expected movement of water molecules inside and across the neuron. Higher values of FA indicate better neuronal integrity (that is, less movement of water across the neuron). There is no range of values, as this is a dimensionless index.|Baseline and Week 12|Although 21 completed the study, only 18 were analyzed for this measure. This is because DTI FA data was collected for only 18 subjects. Reasons for not completing DTI: 1 subject had a brain abnormality; 1 subject refused to do the scan; and 1 scan was not completed due to scanner shutdown for maintenance.|||DTI Fractional Anisotropy (FA) value||Standard Deviation|Mean
2553557|NCT02774343|Primary|Cue Reactivity as Assessed by a Visual Analogue Scale (VAS) of Cocaine Craving|"Every two weeks, visual analog scale ratings of craving (VAS craving) consisting of 100 mm line, anchored by 0 not at all and 100 extremely, were used to assess cocaine craving right now, craving on average in the past week, and the worst craving in the past week. Data were analyzed as a total score, which is the sum of the scores for the three questions."|Baseline, week 2, week 4, week 6, week 8, week 10, week 12||||units on a scale||Standard Deviation|Mean
2553558|NCT02774343|Primary|Craving as Assessed by the Obsessive Compulsive Drug Use Scale (OCDUS)|The obsessive compulsive drug use scale (OCDUS) measures the level of craving for cocaine during the past week. The mean score over all time points is reported in this outcome measure (i.e., a summary score is reported). The scale was administered once weekly. It consists of 12 items. The score range is 0 to 60, and higher scores indicates greater craving.|Weeks 1-12||||units on a scale||Standard Deviation|Mean
2553559|NCT02774343|Primary|Craving as Assessed by the Brief Substance Craving Scale (BSCS)|The brief substance craving scale (BSCS) is a 16-item, self-report instrument assesses craving for cocaine and other substances of abuse over a 24 hour period. The domains of intensity, frequency, and duration are recorded on a five-point Likert scale. The range of scores for each domain is 0 to 4, and the total score is the sum of all three domains. The total score range is 0 to 12, and higher scores indicate higher craving (worse outcome.)|Baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12||||units on a scale||Standard Deviation|Mean
2553560|NCT02774278|Secondary|Percentage of Participants With Clinical Benefit (CR, PR, or Stable Disease [SD] for at Least 12 Weeks After Study Entry) Using RECIST|Clinical benefit was defined as either a CR, PR, or SD prior to failure (disease progression, death from any cause, or a second malignancy). CR: complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. PR: greater than or equal to 50% reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non-target lesions. PD: unequivocal progression of existing non-target lesions.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|Analysis population included all enrolled participants.|||percentage of participants||95% Confidence Interval|Number
2553561|NCT02774278|Secondary|Percentage of Participants With Overall Response of Complete Response (CR) or Partial Response (PR) Using Response Evaluation Criteria in Solid Tumors (RECIST)|Tumor response was defined as either a CR or a PR prior to failure (disease progression, death from any cause, or a second malignancy). CR was defined as the complete disappearance on magnetic response imaging of all enhancing tumor and mass effect on a stable or decreasing dose of dexamethasone (or only receiving adrenal replacement doses) accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks. PR was defined as a greater than or equal to 50 percent (%) reduction in tumor size by bi-dimensional measurement on a stable or decreasing dose of dexamethasone accompanied by a stable or improving neurologic examination that was maintained for at least 12 weeks.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|Analysis population included all enrolled participants.|||percentage of participants||95% Confidence Interval|Number
2553562|NCT02774278|Primary|Number of KRAS Mutation Participants Who Achieved Clinical Benefit|Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with KRAS gene mutation and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|PAS participants who had KRAS mutation at baseline were included in this analysis.|||participants|||Number
2553563|NCT02774278|Primary|Number of Epidermal Growth Factor Receptor (EGFR) Mutation Participants Who Achieved Clinical Benefit|Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Number of participants with EGFR mutation (L858R/ exon 19 deletion) and who achieved clinical benefit status was reported. Clinical benefit is defined in the Outcome Measure 5.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|PAS participants who had EGFR mutation at baseline were included in this analysis.|||participants|||Number
2553564|NCT02774278|Primary|Number of Differentially Expressed Genes Associated With Clinical Benefit|Affymetrix gene expression profiles were primarily analyzed to identify differentially expressed genes between the participants who derived clinical benefit status and those who did not. Analysis was performed using a multivariate linear model (with clinical benefit status, histology, ethnicity, sex, RNA integrity number (RIN), smoking status and stage as predictors), and a False Discovery Rate criteria of below 0.3 as cut-off. Clinical benefit is defined in the Outcome Measure 5.|Baseline until disease progression, unacceptable toxicity or death, evaluated up to 4 years|Primary analysis set (PAS) included all participants who provided evaluable tissue samples and were included in the primary Affymetrix efficacy analysis.|||genes|||Number
2553565|NCT02774265|Secondary|Number of Participants With Pulmonary Embolism Events|Bases on imaging obtained for symptoms.|90 days|As per flow sheet|||Participants|||Count of Participants
2553566|NCT02774265|Secondary|Number of Participants With Deep Venous Thromboembolism|DVT and how the diagnosis was made will be recorded. The number of events in participants in each arm will be compared to evaluate efficacy.|90 days|same as flow chart|||Participants|||Count of Participants
2553567|NCT02774265|Primary|Number of Participants With Treatment-related Bleeding Events as Assessed by the Need for Blood Transfusions and Procedures for Bleeding Complications After Initiation of the Study Medication.|Includes a greater than 2g/dL drop in hemoglobin, blood transfusion, hematoma evacuation, re-operation for a deep surgical site infection or minor procedure for bleeding and GI bleed|90 days|As described in Participant Flow|||Participants|||Count of Participants
2553568|NCT02774213|Secondary|Patient's Change From Baseline of Pain Interference as Measured by the Brief Pain Inventory (BPI)|"The pain interference score of BPI is an arithmetic average of the 7 interference scores reported on an 11-point NRS going from 0 (does not interfere) to 10 (completely interferes)~The BPI interference questions are:~9. Pain has interfered in the last 24 hours with~General Activity?~Mood?~Walking Abililty?~Work?~Relations with other people?~Sleep?~Enjoyment of life?"|Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)||||score on a scale||Standard Deviation|Mean
2553569|NCT02774213|Secondary|Patient's Change From Baseline of Quality-of-Life Questionnaire in 30 Questions (QLQ-C30).|Pain scale of the Quality-of-Life Questionnaire in 30 questions (QLQ-C30); 2 items in the Pain scale ranging each from 1 to 4 (high score for a symptom scale / item represents a high level of symptomatology / problems); Pain score is sum of of the 2 items|Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)||||score on a scale||Standard Deviation|Mean
2553570|NCT02774213|Secondary|Patient's Change From Baseline of Pain Intensity Measured After Clinical Pain Assessments (CPAs)|Number of symptoms measured after Clinical Pain Assessments (CPAs), 0 no symptom to 3 all the three symptoms : Hyperalgesia, Hypoesthesia, and Sensory loss.|Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)||||Number of symptoms||Standard Deviation|Mean
2553571|NCT02774213|Secondary|Patient's Change From Baseline of Patient Global Assessment of Changes (PGAC)|Patient subjective evaluation of patient condition using an 11-point NRS with 0 meaning best and 10 worst|Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)|Only the patients completing the study per protocol were analyzed. PGAC was available for 50 patients amongst the per protocol completers.|||units on a scale||Standard Deviation|Mean
2553572|NCT02774213|Secondary|Patient's Change From Baseline of Investigator Global Assessment of Changes (IGAC)|Investigator subjective evaluation of patient condition using an 11-point NRS with 0 meaning best and 10 worst|Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)|Only the patients completing the study per protocol were analyzed. IGAC was available for 48 patients amongst the per protocol completers.|||units on a scale||Standard Deviation|Mean
2553573|NCT02774213|Secondary|Patient's Change From Baseline of Pain Severity as Measured by the Brief Pain Inventory (BPI)|"The pain severity score of BPI is an arithmetic average of the 4 severity scores reported on an 11- point NRS going from 0 (no pain) to 10 (pain as bad as you can imagine).~The BPI severity questions are:~3. Your pain at its worst in the last 24 hours? 4. Your pain at its least in the last 24 hours? 5. Your pain on the average? 6. How much pain you have right now?"|Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)|Only the patients completing the study per protocol were analyzed. APS was available for 51 patients amongst the per protocol completers.|||score on a scale||Standard Deviation|Mean
2553574|NCT02774213|Secondary|Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Worst Pain Score (WPS)|11-point Numeric Rating Scale from 0 to 10 with 0 meaning no pain and 10 pain as bad as you can imagine; baseline measure was was the mean of the WPS of the first 7 days after first visit (Visit 1); end of study measure was the mean of the WPS of the last 7 days prior to last visit (Visit 2)|Time zero equals baseline up to after at least 4 weeks of treatment (Visit 2)|Only the patients completing the study per protocol were analyzed. WPS was available for 46 patients amongst the per protocol completers.|||units on a scale||Standard Deviation|Mean
2553575|NCT02774213|Primary|Patient's Change From Baseline of Pain Severity, as Measured by the Weekly Means of the Daily Average Pain Scores (APS)|11-point Numeric Rating Scale from 0 to 10 with 0 meaning no pain and 10 pain as bad as you can imagine; baseline measure was the Weekly Average Pain Score (WAPS), over the week first visit (the last 7 days); end of study measure was the mean of the APS of the last 7 days prior to last visit (Visit 2)|Time zero equals baseline up to after at least 4 weeks of observation (Visit 2)|Only the patients completing the study per protocol were analyzed. APS was available for 47 patients amongst the per protocol completers.|||units on a scale||Standard Deviation|Mean
2553576|NCT02774148|Secondary|Hospital Stay|Length of hospital stay will be compared between the two groups.|2 weeks|No analyses complete due to early termination.||||||
2553577|NCT02774148|Secondary|Distance Ambulated|The distance ambulated will be compared between the two groups.|6 days|No analyses complete due to early termination.||||||
2553578|NCT02774148|Secondary|Timing of First Day of Ambulation.|The timing of the first day of ambulation will be compared between the two groups.|6 days|No analyses complete due to early termination.||||||
2553579|NCT02774148|Secondary|The Amount of Morphine Equivalents, as Determined by an Opioid Dose Calculator, Received by the Patient.|The amount of opioid pain medication a patient receives will be recorded and the Morphine equivalents will be determined by an opioid dose calculator. The morphine equivalents will be compared between the two groups.|6 days|No analyses complete due to early termination.||||||
2553580|NCT02774148|Primary|Pain Score|Pain scores will be compared between the two groups.|6 days|No analyses complete due to early termination.||||||
2553581|NCT02773836|Secondary|Number of Participants Who Think About the Harm Their Smoking Might be Doing to Other People|"The following question ask you about how often you've had certain thoughts in the last 30 days. In the last 30 days, how often did you Think about the harm your smoking might be doing to other people?~Never~Rarely~Sometimes~Often~Very often~8 Refused 9 Don't know"|Post-TPD||||Participants|||Count of Participants
2553582|NCT02773836|Secondary|Number of Participants Who Think About The Money They Spend on Smoking|"The following question ask you about how often you've had certain thoughts in the last 30 days. In the last 30 days, how often did you Think about the money you spend on smoking?~Never~Rarely~Sometimes~Often~Very often~8 Refused 9 Don't know"|Post-TPD||||Participants|||Count of Participants
2553583|NCT02773836|Secondary|Number of Participants Who Think About the Harm Their Smoking Might be Doing to Other People|"The following question ask you about how often you've had certain thoughts in the last 30 days. In the last 30 days, how often did you Think about the harm your smoking might be doing to other people?~Never~Rarely~Sometimes~Often~Very often~8 Refused 9 Don't know"|Baseline Pre-TPD||||Participants|||Count of Participants
2553584|NCT02773836|Secondary|Number of Participants Who Think About The Money They Spend on Smoking|"The following question ask you about how often you've had certain thoughts in the last 30 days. In the last 30 days, how often did you Think about the money you spend on smoking?~Never~Rarely~Sometimes~Often~Very often~8 Refused 9 Don't know"|Baseline Pre-TPD||||Participants|||Count of Participants
2553585|NCT02773836|Primary|Number of Participants Who Plan to Quit Smoking|"Are you planning to quit smoking . . .~Within the next month~Within the next 6 months~Sometime in the future, beyond 6 months~Or are you not planning to quit?~8 Refused 9 Don't know"|Post-TPD||||Participants|||Count of Participants
2553586|NCT02773836|Primary|Number of Participants Who Have Ever Tried to Quit Smoking|"Have you ever tried to quit smoking?~Yes~No~8 Refused 9 Don't know"|Post-TPD||||Participants|||Count of Participants
2553587|NCT02773836|Primary|Number of Participants Whose First Cigarette After Waking is 30 Mins or Less|"How soon after waking do you usually have your first smoke? responses:~5 min or less~6-30 min~31-60 min~More than 60 min"|Post-TPD||||Participants|||Count of Participants
2553588|NCT02773836|Primary|Number of Participants Who Think About the Harm of Smoking|"In the last 30 days, how often did you think about the harm your smoking might be doing to you? responses:~Never~Rarely~Sometimes~Often~Very often~8 Refused 9 Don't know"|Post-TPD||||Participants|||Count of Participants
2553589|NCT02773836|Primary|Number of Participants Who Plan to Quit Smoking|"Are you planning to quit smoking . . .~Within the next month~Within the next 6 months~Sometime in the future, beyond 6 months~Or are you not planning to quit?~8 Refused 9 Don't know"|Baseline Pre-TPD||||Participants|||Count of Participants
2553591|NCT02773836|Primary|Number of Participants Who Think About How Much They Enjoy Smoking by Frequency|"The following question ask you about how often you've had certain thoughts in the last 30 days. In the last 30 days, how often did you . . .~Think about how much you enjoy smoking?~Never~Rarely~Sometimes~Often~Very often~Refused~Don't know"|Baseline Pre-TPD||||Participants|||Count of Participants
2553592|NCT02773836|Primary|Number of Participants Whose First Cigarette After Waking is 30 Mins or Less|"How soon after waking do you usually have your first smoke? responses:~5 min or less~6-30 min~31-60 min~More than 60 min"|Baseline Pre-TPD||||Participants|||Count of Participants
2553593|NCT02773836|Primary|Number of Participants Who Think About the Harm of Smoking|"In the last 30 days, how often did you think about the harm your smoking might be doing to you? responses:~Never~Rarely~Sometimes~Often~Very often~8 Refused 9 Don't know"|Baseline Pre-TPD||||Participants|||Count of Participants
2553594|NCT02773758|Secondary|Change From Baseline in Tactile Threshold at Day 7 and Day 14|A tactile stimulus was administered using a constant pressure probe (Yeaple Probe). Response to this stimulus was evaluated as tactile threshold. The constant pressure probe allowed the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80 g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant's reporting pain or discomfort. The greater the tactile threshold, the less sensitive the tooth.|Baseline, Day 7 and Day 14|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.|||gram (g)||Standard Deviation|Mean
2553595|NCT02773758|Secondary|Change From Baseline in Schiff Sensitivity Score at Day 7|Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.|Baseline, Day 7|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
2553596|NCT02773758|Primary|Change From Baseline in Schiff Sensitivity Score at Day 14|Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.|Baseline, Day 14|Analysis for this outcome was conducted on Intent-to-treat (ITT) population which included all participants who were randomized, received at least one dose of the study treatment and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
2553597|NCT02773576|Other Pre-specified|Change of Sleep Quality From Baseline to Month 12 Measured on the Pittsburgh Sleep Quality Index (PSQI)|The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.|Baseline and 12 months|The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.||||||
2553598|NCT02773576|Secondary|Incidence of Psychotic Symptom Exacerbation/Impending Relapse|The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.|12 months|The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.||||||
2553599|NCT02773576|Primary|Number of Participants With Treatment-related Adverse Events as Assessed|The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.|12 months|The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.||||||
2553600|NCT02773537|Secondary|Patient Reported Pain and Function Outcomes|"Short Form Health Survey (SF-12): 12 item abbreviated form of SF-36 survey that provides information about how participants feel, and how well they have been able to perform their usual activities. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning.~Patient Reported Outcome Measurement Information System (PROMIS): evaluates and monitors physical, mental, and social health. The minimum possible score is 20, the maximum is 100.~Knee injury and Osteoarthritis Outcome Score (KOOS)-Specifically Pain and Symptom Score: A Likert scale is used. All items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale (0=extreme; 100= none)."|3 Months after Procedure||||score on a scale||Standard Deviation|Mean
2553623|NCT02773368|Secondary|Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments|Mean prandial plasma glucose increments for each meal (from before meal to 90 min after breakfast, lunch and dinner) was evaluated after 26 weeks of randomised treatment. The mean increment over all meals was derived as the mean of all available meal increments are presented here.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.|||mmol/L||Standard Deviation|Mean
2553601|NCT02773537|Secondary|Patient Reported Pain and Function Outcomes|"Short Form Health Survey (SF-12): 12 item abbreviated form of SF-36 survey that provides information about how participants feel, and how well they have been able to perform their usual activities. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning.~Patient Reported Outcome Measurement Information System (PROMIS): evaluates and monitors physical, mental, and social health. The minimum possible score is 20 and the max is 100.~Knee injury and Osteoarthritis Outcome Score (KOOS)-Specifically Pain and Symptom Score: A Likert scale is used. All items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale (0=extreme; 100= none)."|6 Weeks after procedure||||score on a scale||Standard Deviation|Mean
2553602|NCT02773537|Secondary|Functional Outcome Measures- TUG (Timed Up and Go)- Time in Seconds|Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #2, the therapist will document a timed up-and-go test (TUG).|Morning of post-op day 1 - 2 days after procedure||||seconds||Standard Deviation|Mean
2553603|NCT02773537|Secondary|Functional Outcome Measures- TUG (Timed Up and Go)- Distance Walked|Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #2, the therapist will document distance walked by the patient.|Morning of post-op day 1 - 2 days after procedure||||Feet||Standard Deviation|Mean
2553604|NCT02773537|Secondary|Functional Outcome Measures- AMPAC (Activity Measure for Post-Acute Care)|Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #1, the therapist will calculate the Activity Measure for Post-Acute Care (AM-PAC) score. The Activity Measure for Post Acute Care (AM-PAC) measures function in three domains: basic mobility, daily activities,and applied cognitive function. AM-PAC scores in each functional domain have a mean of 50 with a standard deviation of 10 and scores are distributed along a continuum of function. The AM-PAC tracks outcomes as a participant progresses across an episode of care with higher scores indicating an improved level of functioning.|Morning of post-op day 1 - 2 days after procedure||||score on a scale||Standard Deviation|Mean
2553605|NCT02773537|Secondary|Functional Outcome Measures- Exstension/Knee Buckling|Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. They will document the patient's ability to perform independent terminal knee extension and grade knee buckling with ambulation on a scale of 0-2 during each encounter. A grade of 0 indicates no knee buckling, 1 indicates slight buckling, and a grade of 2 represents knee buckling significant enough in the opinion of the physical therapist to require a knee immobilizer while ambulating. I higher score corresponds to a worse outcome. The numbers below in the outcome measure table are the number of patients who achieved terminal knee extension for had ANY knee buckling respectively.|1-2 days after procedure||||number of participants|||Number
2553606|NCT02773537|Secondary|Narcotic Requirements|Narcotic dosages will be measured and reported as oral morphine milligram equivalents.|48 hours after procedure||||milligrams of morphine equivalents||Inter-Quartile Range|Mean
2553607|NCT02773537|Primary|Pain Measurement Via VAS (Visual Analog Scale)|The primary outcome measure will be postoperative visual analog pain scale (VAS) score area under the curve (AUC) for 48 hours, recorded every six hours. Score Scale is 0 (no pain)- 10(most pain). A higher score corresponds to a worse outcome.|48 hours after procedure||||score on a scale||Standard Deviation|Mean
2553608|NCT02773446|Secondary|Immune Response to Challenge|Antibody in Lymphocyte Supernatant (ALS) Immunoglobin G (IgG) (CS6) coli surface antigen 6 Immunoglobin G (IgG) heat labile Toxin (LT) Immunoglobin G (IgG) (LPS) Lipopolysaccharide Immunoglobin A (IgA) (CS6) coli surface antigen 6 Immunoglobin A (IgA) heat labile Toxin (LT) Immunoglobin A (IgG) (LPS) Lipopolysaccharide|6 days post challenge|samples for ALS IgG and IgA were unavailable for 1 participant in cohort 2 group A Samples for ALS IgG CS6, LT and IgA CS6 were unavailable for 1 participant in cohort 2 group B|||participants|||Number
2553609|NCT02773446|Secondary|Immune Response to Challenge (Serology)||28 days post challenge||||Participants|||Count of Participants
2553610|NCT02773446|Primary|Number of Participants With Safety -Solicited Symptoms Unrelated to Challenge Administration|Safety solicited symptoms unrelated to challenge administration (vomiting, abdominal pain, bloating, lightheadedness, anorexia, generalized myalgia, arthralgias, abdominal cramping, constipation, nausea, malaise, headache, flatulence)|6 days post-challenge||||Participants|||Count of Participants
2553611|NCT02773446|Primary|Moderate-severe Diarrhea in Subjects Receiving Homologous Rechallenge|"Moderate-severe diarrhea post-challenge defined as~Moderate diarrhea: 4 to 5 loose/liquid stools or 401-800g of loose/liquid stool in any 24- hour period~Severe diarrhea: greater than or equal to 6 loose/liquid stools or greater than 800 g of loose/liquid stool in any 24-hour period"|7 days post-challenge||||Participants|||Count of Participants
2553612|NCT02773446|Primary|Moderate-severe Diarrhea|"Moderate-severe diarrhea post challenge defined as~moderate diarrhea: 4 to 5 loose/liquid stools or 401-800 of loose/liquid stool in any 24-hour period~Severe diarrhea greater than or equal to 6 loose/liquid stools or greater than 800 g of loose/liquid stools in any 24-hour period"|5 days post challenge (Cohort 1 and Cohort 2 group B) 7 days post challenge (Cohort 2 Group A)||||Participants|||Count of Participants
2553613|NCT02773446|Primary|Number of Participants With Safety- Solicited Symptoms Related to Challenge Administration|Solicited symptoms (vomiting, abdominal pain, bloating, lightheadedness, anorexia, generalized myalgia, arthralgias, abdominal cramping, constipation, nausea, malaise, headache, flatulence)|6 days post-challenge||||Participants|||Count of Participants
2553658|NCT02771522|Secondary|Number of Non-patient Related Adverse Events With the Calcivis System|All adverse events and device deficiencies were collected throughout the study on Adverse Event Forms|0 days, 2, 4, 8 and 12 weeks|All patients imaged with the Calcivis System|||Non-patient-related Adverse Events|||Number
2553614|NCT02773368|Secondary|Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D)|The patient reported outcomes are calculated based on TRIM-D questionnaire. The TRIM-D questionnaire consists of 5 sub-domains (treatment burden, daily life, diabetes management, compliance and psychological health), where each question is scored to a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D domain scores and the total scores are later transformed to a 0-100 scale for analysis. Summary scores from baseline and week 26 for total/overall scores are presented here.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline and week 26.|||Scores on a scale||Full Range|Median
2553615|NCT02773368|Secondary|Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2)|The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL). PRO questionnaire (SF-36v2™) measured the HRQoL which contains 36 items covering 8 domains of physical and mental health status. The raw scale scores from the SF-36 were transformed to a 0-100 scale scores (where higher scores indicated a better health status) which is further converted to norm-based scores using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 2009 reference population . The total/overall (SF-36v2™) scores for physical and mental health from baseline to week 26 are presented here.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline and week 26 for overall physical and mental scores.|||Scores on a scale||Full Range|Median
2553616|NCT02773368|Secondary|Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate|Change from baseline (week 0) in pulse rate was evaluated after 26 weeks of randomised treatment.|After 26 weeks|The safety analysis set included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation “as treated”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.|||Beats/minute||Standard Deviation|Mean
2553617|NCT02773368|Secondary|Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography|Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is <= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 4) Missing.|After 26 weeks|The safety analysis set included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation “as treated”. Number analysed = Number of subjects contributed to the analysis at screening and week 26.|||Number of subjects|||Number
2553618|NCT02773368|Secondary|Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG)|Reported results are ECG findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is <= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 4) Missing.|After 26 weeks|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation “as treated”. Number analysed = Number of subjects contributed to the analysis at screening and week 26.|||Number of subjects|||Number
2553619|NCT02773368|Secondary|Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks|American Diabetes Association (ADA) classification of hypoglycaemic episodes: 1)Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo: PG >3.9 mmol/L with symptoms. 6) Unclassifiable.|Week 0-26|The safety analysis set included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation “as treated”.|||Number of episodes|||Number
2553620|NCT02773368|Secondary|Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks|Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes (00:01-05:59 - inclusive) during 26 weeks of randomised treatment.|Week 0-26|The safety analysis set included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation “as treated”.|||Number of episodes|||Number
2553621|NCT02773368|Secondary|Change From Baseline in Diastolic Blood Pressure|Change from baseline (week 0) in diastolic blood pressure was evaluated after 26 weeks of randomised treatment.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.|||mmHg||Standard Deviation|Mean
2553622|NCT02773368|Secondary|Change From Baseline in Systolic Blood Pressure|Change from baseline (week 0) in systolic blood pressure (BP) was evaluated after 26 weeks of randomised treatment.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.|||mmHg||Standard Deviation|Mean
2553659|NCT02771522|Primary|Presence or Absence of Elevated Luminescence|Percentage of active teeth showing luminescence (as measured by Calcivis System imaging) over time, per Investigator|0, 2, 4, 8 and 12 weeks post de-bond|From a total of 30 participants (28 patients from Investigator 1, and 2 patients from Investigator 2) a total of 119 teeth were imaged at baseline then different numbers of patients attended different follow-up visits|||% active teeth with luminescence|Teeth||Number
2553624|NCT02773368|Secondary|Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile|Change in mean of the 9-point profile SMPG was evaluated after 26 weeks of randomised treatment. 9-point profile SMPG was measured at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.|||mmol/L||Standard Deviation|Mean
2553625|NCT02773368|Secondary|Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile|Change in 9-point SMPG profile was evaluated after 26 weeks of randomised treatment. SMPG measurements at baseline and week 26 are presented here at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline and week 26 for mentioned time points.|||mmol/L||Standard Deviation|Mean
2553626|NCT02773368|Secondary|Change From Baseline in Fasting Lipid Profile: Free Fatty Acids|The values of free fatty acids from fasting lipid profile after 26 weeks of randomised treatment.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.|||mmol/L||Full Range|Median
2553627|NCT02773368|Secondary|Change From Baseline in Fasting Lipid Profile: Triglycerides|The values of triglycerides from fasting lipid profile after 26 weeks of randomised treatment.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.|||mmol/L||Full Range|Median
2553628|NCT02773368|Secondary|Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol)|The values of VLDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.|||mmol/L||Full Range|Median
2553629|NCT02773368|Secondary|Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol)|The values of HDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.|||mmol/L||Full Range|Median
2553630|NCT02773368|Secondary|Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol)|The values of LDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.|||mmol/L||Full Range|Median
2553631|NCT02773368|Secondary|Change From Baseline in Fasting Lipid Profile: Cholesterol|The values of total cholesterol from fasting lipid profile after 26 weeks of randomised treatment.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.|||mmol/L||Full Range|Median
2553632|NCT02773368|Secondary|Change From Baseline After 26 Weeks in Waist Circumference|Mean change from baseline in waist circumference after 26 weeks of randomised treatment.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.|||cm||Standard Deviation|Mean
2553633|NCT02773368|Secondary|Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain|The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.|||Partcipants|||Number
2553634|NCT02773368|Secondary|Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment|The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.|||Particpants|||Number
2553660|NCT02771522|Primary|Presence or Absence of Elevated Luminescence|Percentage of active teeth showing luminescence (as measured by Calcivis System imaging) over time|0, 2, 4, 8 and 12 weeks|From 30 participants a total of 119 teeth were imaged at baseline then different numbers of patients attended different follow-up visits|||% active teeth with luminescence|Teeth||Number
2553635|NCT02773368|Secondary|Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain|The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% without weight gain after 26 weeks of randomised treatment. The results are based on retrieved data at week 26 for subjects who prematurely discontinued the trial product.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.|||Participants|||Number
2553636|NCT02773368|Secondary|Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5%|The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.|||Participants|||Number
2553637|NCT02773368|Secondary|Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain|The proportion of subjects achieving pre-defined HbA1c targets <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.|||Participants|||Number
2553638|NCT02773368|Secondary|Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment|The proportion of subjects achieving pre-defined HbA1c targets <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.|||Participants|||Number
2553639|NCT02773368|Secondary|Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain|The proportion of subjects achieving pre-defined HbA1c targets <7.0% without weight gain after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.|||Participants|||Number
2553640|NCT02773368|Secondary|Responder (Yes/No) for HbA1c Below 7.0%|The proportion of subjects achieving pre-defined HbA1c targets <7.0% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.|||Participants|||Number
2553641|NCT02773368|Secondary|Number of Treatment-emergent Adverse Events|Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 26. TEAE was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.|Week 0-26|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation “as treated”.|||Number of events|||Number
2553642|NCT02773368|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline (week 0) in FPG was evaluated after 26 weeks of randomised treatment.|Week 0, Week 26|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.|||mmol/ L||Standard Deviation|Mean
2553643|NCT02773368|Secondary|Insulin Dose, Total Daily Dose (U)|Actual daily total insulin dose (Units) was evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.|After 26 weeks|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at week 26.|||Units (U)||Standard Deviation|Mean
2553644|NCT02773368|Secondary|Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes|Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe (subjects who were not able to self-treat) and/or BG confirmed by a plasma glucose values <3.1 mmol/L (56 mg/dL) with accompanied symptoms consistent with hypoglycaemia.|Week 0-26|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation “as treated”.|||Number of episodes|||Number
2553645|NCT02773368|Secondary|Change in Body Weight|The mean change from baseline (week 0) in body weight evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.|Week 0, Week 26|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline and week 26.|||kg||Standard Deviation|Mean
2553714|NCT02770625|Other Pre-specified|Assessment of AEs, Vital Signs, Physical Examination, and Electrocardiogram (ECG)||Screening to Visit14 (Week 26)|||||||
2553715|NCT02770625|Secondary|Change in Bone Mineral Density||from baseline to Week 24||||g/cm^2||Standard Deviation|Mean
2553646|NCT02773368|Primary|Change in HbA1c (Glycosylated Haemoglobin)|The mean change from baseline (week 0) in HbA1c values evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.|Week 0, Week 26|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Number analysed = Number of subjects contributed to the analysis at baseline and week 26.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
2553647|NCT02772757|Secondary|Satisfaction With Amplification in Daily Life (SADL)|The SADL questionnaire has 15 items that examine self-reported hearing-aid satisfaction. The following four subscales are included: (1) positive effect, (2) negative features, (3) personal image, and (4) service and cost. Item 14 is omitted in populations who do not pay for hearing aids. Responses are on a 1 to 7 scale with higher numbers reflecting higher outcomes. The item responses are averaged to determine the total satisfaction score that can range from 1-7. The minimum and maximum total scores for the three groups were: standard of care group (5.1-7.0); average RECD group (4.2-6.9), and measured RECD group (4.9-7.0).|1 month post-fitting|Two participants in the Measured RECD group did not wear the replacement hearing aids due to comfort and thus did not complete self-report measures related to the field trial.|||units on a scale||Standard Deviation|Mean
2553648|NCT02772757|Secondary|Device Oriented Subjective Outcome (DOSO) Scale|The questionnaire is comprised of 28 items making up the following six subscales related to listening performance with hearing aids: (1) speech cues, (2) listening effort, (3) pleasantness, (4) quietness, (5) convenience, and (6) use. Responses from 'not at all' (1 point) to tremendously (7 points) are recorded for each item and are averaged across all items to obtain a total scale score. Higher scores reflect higher outcomes. The minimum and maximum total scores can range from 1-7 and for the three groups were: standard of care group (3.8-6.8), Average RECD group (3.3-6.7), and measured RCD group (3.8-6.5).|1 month post-fitting|Two participants in the Measured RECD group did not wear the replacement hearing aids due to comfort and thus did not complete self-report measures related to the field trial.|||units on a scale||Standard Deviation|Mean
2553649|NCT02772757|Secondary|Client-Oriented Scale of Improvement (COSI)|The listener nominates up to five listening goals. After hearing-aid use, the listener assesses two outcomes for each goal. One outcome is the degree of change relative to the patient's unaided experience. Responses are recorded on a 5 unit categorical scale from 'worse' to 'much better'. The second outcome is the final satisfactory 'aided' ability for each goal as measured on a 5 unit categorical scale from hardy ever (10%) to almost always (95%). Higher scores reflect better outcomes for nominated goals. We calculated the percent of better and much better responses over the nominated goals and the average satisfactory aided ability over the nominated goals.|1 month post-fitting|One participant in the Average RECD group and one participant in the Measured RECD group declined to nominate listening goals and complete the measure. Two additional participants in the Measured RECD group did not wear the replacement hearing aids due to comfort and thus did not complete self-report measures related to the field trial.|||percentage of change or ability||Standard Deviation|Mean
2553650|NCT02772757|Primary|in Situ Real-ear Aided Response (REAR)|Deviation from prescriptive target (re: in situ REAR) from both ears of each participant for each group. This measure reflects the accuracy of the hearing aid fittings from 250 Hz through 3000 Hz (the average bandwidth of audibility).|at the visit where in-situ real ear measurements are made (immediate post-fitting)||||dB||Standard Deviation|Mean
2553651|NCT02772666|Primary|Number of Participants With Detected Relative Afferent Pupillary Defect (RAPD)|"The instrument illuminated the eyes alternatively and took images and recorded pupillary reflex to this light stimulation.~All of 44 patients were examined with two methods, SFT and O Glass. SFT method: The well known manual method to diagnose RAPD. O glass method:The device consists of camera and light sources.The red light was on and off for a 5 second interval. Then the white light was on for right eye and 3 seconds later the system captured an image. After 0.5 second the right light was off and the left light turned on, 3 seconds later the image was captured. The images were processed and analyzed using computerized software."|up to 6 months||||participants|||Number
2553652|NCT02772432|Secondary|Stress Reactivity|The Measure of Current Status Part A (MOCS-A) is a 13-item self-report measure developed to assess participants' current self-perceived status on several skills: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. Scores can range from 0 to 52, and higher scores are correlated with greater self- perceived proficiency with these skills.|change between baseline (week 0) to 12 weeks post intervention||||score on a scale||Standard Deviation|Mean
2553653|NCT02772432|Primary|Current Experiences Scale|The CES is a 25-item measure of resilience adapted from the Post-Traumatic Growth Inventory (PTGI) to reflect current functioning in the domains of appreciation for life (AL), adaptive perspectives (AP), personal strength (PS), spiritual connectedness (SC), relating to others (RO), and an additional four items to assess current adaptive health behaviors (HB) that are not part of the PTGI. The CES is scored on a scale from 0-125 with higher scores indicating greater resilience.|Change between baseline and 12-weeks||||score on a scale||Standard Deviation|Mean
2553654|NCT02772432|Primary|Distress|The Visual Analog Scale (VAS)-Distress is a 1-item scale which asks responders to rate their level of distress on a scale of 0 to 10. A higher score indicates more distress.|change between baseline (week 0) to 12 weeks post intervention||||score on a scale||Standard Deviation|Mean
2553655|NCT02771522|Secondary|User Questionnaires|Completion of User Questionnaires after imaging with the Calcivis System|Baseline visit|User Questionnaires were completed by the dentist and nurse at the end of every imaging session about their experiences using the Calcivis System. They were asked to tick the most appropriate response on a three-point scale e.g. easy, neither easy nor difficult , difficult.|||User Questionniares|Questionnaires||Number
2553656|NCT02771522|Secondary|Patient Experience|Completion of Patient Questionnaires after imaging with the Calcivis System at patient's final visit|Final Visit - either 8 or 12 weeks post debond|Patient Questionnaires comprised two questions and patients asked to tick the most appropriate response on a three-point scale|||Participants|||Number
2553657|NCT02771522|Secondary|Patient Experience|Completion of Patient Questionnaires after imaging with the Calcivis System|Baseline|Patient Questionnaires comprised of two questions and patients were asked to tick the most appropriate response on a three-point scale|||participants|||Number
2553661|NCT02771366|Primary|Magnetic Resonance Spectroscopy (MRS) Will Measure a Change in Cerebral Energy Function in Brain Tissue|"Cerebral energy metabolism will be defined by phosphorus magnetic resonance spectroscopy markers of ATP/mitochondrial function in brain tissue (α-ATP, β-ATP, and γ-ATP).~Within-subject crossover design; difference between drug and placebo arms. Treatment duration: weeks 0-8 followed by washout then weeks 14 to 22.~Data reported in the outcome measures data table represents difference between pre and post measurement values (post-pre) for each arm."|Participants received MRS at weeks 0, 8, 14, and 22. Data reported in the outcome measures data table represents difference between pre and post measurement values (post-pre) for each arm.|26 completed subjects eligible for analysis. Data acquisition errors in 6 subjects reduced the complete sample to 20 (data from 20 subjects with complete data presented in outcome measures table).|||Difference in metabolite amplitude||Standard Deviation|Mean
2553662|NCT02771275|Secondary|Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days|Subject's freedom from Serious Adverse Events at >30 days post-implant. Time to events were estimated by Kaplan-Meier method.|6 months, 12 months, 18 months, 24 months, and 30 months|This outcome is reported for subjects who received the Harpoon Medical Device where data is available.|||percentage of subjects|||Number
2553663|NCT02771275|Secondary|Subject's Severity of Mitral Regurgitation Over Time|"Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. The numbers on the scale are reflected as follows: 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak.~Higher numbers on the scale show a worsening outcome."|6 months, 12 months, 18 months, 24 months, and 30 months|This outcome is reported for subjects who received the Harpoon Medical Device where data is available.|||Participants|||Count of Participants
2553664|NCT02771275|Primary|Subject's Serious Adverse Events (SAE) Through Discharge|Number of Participants experiencing a Serious Adverse Event (SAE) through time of Discharge.|Discharge, an average of 8 days post implantation|This outcome is reported for subjects who received the Harpoon Medical Device where data is available.|||Participants|||Count of Participants
2553665|NCT02771275|Primary|Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 30 Days|Subject's freedom from Serious Adverse Events during the ePTFE implantation procedure and at 30 days follow-up. Time to events were estimated by Kaplan-Meier method.|Procedure and 30 days|This outcome is reported for subjects who received the Harpoon Medical Device where data is available.|||percentage of subjects|||Number
2553666|NCT02771275|Primary|Number of Subjects With Procedural Success During the First 30 Days|Procedural success was defined as the patient leaving the operating room with a successful implant of one or more ePTFE cords on the mitral valve and reduced mitral regurgitation from severe to </=moderate at the conclusion of the procedure and at 30 days post-procedure.|30 days|This outcome is reported for enrolled subjects where data is available.|||Participants|||Count of Participants
2553667|NCT02771145|Primary|"Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling."|Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects. Habitual lenses and habitual lens care solution were used at the Day 0 time point.|Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180|Full Analysis Set with non-missing response|||percentage of subjects|||Number
2553668|NCT02771145|Primary|"Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."|Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects. Habitual lenses and habitual lens care solution were used at the Day 0 time point.|Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180|Full Analysis Set with non-missing response|||percentage of subjects|||Number
2553669|NCT02771145|Primary|"Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day."|Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects. Habitual lenses and habitual lens care solution were used at the Day 0 time point.|Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180|Full Analysis Set|||percentage of subjects|||Number
2553670|NCT02771145|Primary|Number of Unscheduled Lens Replacements by Reason|Subjects were dispensed enough contact lenses to follow a 2-week replacement schedule during the study. Lenses replaced at other times were considered unscheduled. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject. All lenses which were replaced are counted. Habitual lenses were used at the Day 0 time point.|Up to Day 180|Full Analysis Set, with specified reason for replacement.|||lenses|||Number
2553671|NCT02771145|Primary|Average Rewetting Drop Frequency at Each Visit|"Subject recorded a response to the question, Averaging over the last 3 days, how many times per day did you use rewetting drops? Habitual lenses were used at the Day 0 time point."|Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180|Full Analysis Set, with non-missing response|||times per day||Standard Deviation|Mean
2553672|NCT02771145|Primary|Lens Wear Time at Each Visit Day|"Subject recorded a response to the question, How many hours have you worn your contact lenses today? Lens wear was measured in hours. Habitual lenses were used at the Day 0 time point."|Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180|Full Analysis Set, with non-missing response|||hours||Standard Deviation|Mean
2553673|NCT02771145|Primary|Average Lens Wear Time (Averaged Over the Last 3 Days) at Each Visit|"Subject recorded a response to the question, Averaging over the last 3 days, how many hours per day did you wear your contact lenses? Lens wear time was summarized as an estimate of the subject's daily wear, averaged over the course of 3 days prior to each scheduled visit, and measured in hours. Habitual lenses were used at the Day 0 time point."|Day 0, Day 7, Day 30, Day 60, Day 90, Day 135, Day 180|Full Analysis Set, with non-missing response|||hours||Standard Deviation|Mean
2560617|NCT02662569|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
2553674|NCT02771145|Primary|Percentage of Eyes With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change at Each Visit|Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using Decimal acuity, where 1.0 (equivalent to 20/20) is considered normal distance-eyesight. A line increase indicates an improvement in VA. Both eyes contributed to the analysis|Day 7, Day 30, Day 60, Day 90, Day 135, Day 180|Full Analysis Set, with non-missing response|||percentage of eyes|Eyes||Number
2553675|NCT02771145|Primary|Percentage of Lens Area Covered by Crystalline Deposits at Each Visit|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. For each visit, the number analyzed represents the number of eyes with film deposits on lens, respectively.|Day 7, Day 30, Day 60, Day 90, Day 135, Day 180|Full Analysis Set|||percentage of lens area|Eyes|Standard Deviation|Mean
2553676|NCT02771145|Primary|Percentage of Lens Area Covered by Film Deposits at Each Visit|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. For each visit, the number analyzed represents the number of eyes with film deposits on lens, respectively.|Day 7, Day 30, Day 60, Day 90, Day 135, Day 180|Full Analysis Set|||percentage of lens area|eyes|Standard Deviation|Mean
2553677|NCT02771145|Primary|Number of Eyes With Crystalline Deposits on Lens by Type at Each Visit|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Both eyes contributed to the analysis.|Day 7, Day 30, Day 60, Day 90, Day 135, Day 180|Full Analysis Set|||eyes|Eyes||Number
2553678|NCT02771145|Primary|Number of Eyes With Film Deposits on Lens by Type at Each Visit|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Both eyes contributed to the analysis.|Day 7, Day 30, Day 60, Day 90, Day 135, Day 180|Full Analysis Set|||eyes|Eyes||Number
2553679|NCT02771145|Primary|Percentage of Eyes With Visibly Clean Lenses at Each Visit|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. Both eyes contributed to the analysis.|Day 7, Day 30, Day 60, Day 90, Day 135, Day 180|Full Analysis Set, with non-missing response|||percentage of eyes|Eyes||Number
2553680|NCT02771093|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events||Up to 29 days|Safety Analysis Set (SAS), SAS was defined as participants who received at least one dose of the study drug.|||Participants|||Count of Participants
2553681|NCT02771093|Secondary|Changes From Baseline in the SD of Nocturnal Blood Glucose Values|Change from baseline in SD of nocturnal blood glucose values at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||mg/dL||95% Confidence Interval|Mean
2553682|NCT02771093|Secondary|Changes From Baseline in the SD of Daytime Blood Glucose Values|Change from baseline in SD of daytime blood glucose values at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||mg/dL||95% Confidence Interval|Mean
2553683|NCT02771093|Secondary|Standard Deviation (SD) of 24-hour Blood Glucose Values||Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||mg/dL||95% Confidence Interval|Mean
2553684|NCT02771093|Secondary|Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia)|Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 110 mg/dL at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||mg·min/dL||95% Confidence Interval|Mean
2553685|NCT02771093|Secondary|Change From Baseline in AUC for Blood Glucose|Change from baseline in AUC for blood glucose levels at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||mg·min/dL||95% Confidence Interval|Mean
2553686|NCT02771093|Secondary|Change From Baseline in Mean Nocturnal Blood Glucose Levels|Change from baseline in mean nocturnal blood glucose levels at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||mg/dL||95% Confidence Interval|Mean
2553687|NCT02771093|Secondary|Change From Baseline in Mean Daytime Blood Glucose Levels|Change from baseline in mean daytime blood glucose levels at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||mg/dL||95% Confidence Interval|Mean
2553688|NCT02771093|Secondary|Change From Baseline in Mean 24-hour Blood Glucose Levels|Change from baseline in mean 24-hour blood glucose levels at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||mg/dL||95% Confidence Interval|Mean
2553689|NCT02771093|Secondary|Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE)|Change from baseline in MAGE at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||mg/dL||95% Confidence Interval|Mean
2553690|NCT02771093|Secondary|Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal|Change from baseline in maximum variation of glucose levels between before and after breakfast, lunch and evening meal at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||mg/dL||95% Confidence Interval|Mean
2553691|NCT02771093|Secondary|Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal|Change from baseline in peak postprandial glucose levels during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||mg/dL||95% Confidence Interval|Mean
2553692|NCT02771093|Secondary|Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia)|Change from baseline in AUC for blood glucose during periods when blood glucose levels was less than 70 mg/dL at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||mg·min/dL||95% Confidence Interval|Mean
2553693|NCT02771093|Secondary|Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)|Change from baseline in cumulative time during periods when blood glucose levels reached 180 mg/dL at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||min||95% Confidence Interval|Mean
2553694|NCT02771093|Secondary|Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)|Change from baseline in cumulative time during periods when blood glucose levels reached 160 mg/dL at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||min||95% Confidence Interval|Mean
2553695|NCT02771093|Secondary|Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)|Change from baseline in cumulative time during periods when blood glucose levels reached 140 mg/dL at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||min||95% Confidence Interval|Mean
2553696|NCT02771093|Secondary|Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)|Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 180 mg/dL at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||mg·min/dL||95% Confidence Interval|Mean
2553697|NCT02771093|Secondary|Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)|Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 160 mg/dL at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||mg·min/dL||95% Confidence Interval|Mean
2553698|NCT02771093|Secondary|Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)|Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 140 mg/dL at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||mg·min/dL||95% Confidence Interval|Mean
2553699|NCT02771093|Secondary|Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal|Change from baseline in AUC for blood glucose when specific blood glucose levels (160 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||mg·min/dL||95% Confidence Interval|Mean
2553700|NCT02771093|Secondary|Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal|Change from baseline in AUC for blood glucose when specific blood glucose levels (140 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||mg·min/dL||95% Confidence Interval|Mean
2553701|NCT02771093|Secondary|Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal|Change from baseline in AUC for blood glucose when specific blood glucose levels (110 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||mg·min/dL||95% Confidence Interval|Mean
2553702|NCT02771093|Secondary|Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal|Change from baseline in AUC for blood glucose when specific blood glucose levels (180 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug. The number analyzed is the number of participants with data available for analysis at the given time-point.|||mg·min/dL||95% Confidence Interval|Mean
2553703|NCT02771093|Primary|Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values|Changes in the SD of 24-hour blood glucose values (mg/dL) for each 7-day period between Week 3 and Week 4 (between Day 2 on Week 3 [Day 22] and Day 8 on Week 3 [Day 28]) of the treatment period, calculated from the value at the start of the observation period.|Baseline, up to 28 days|Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.|||mg/dL||95% Confidence Interval|Mean
2553716|NCT02770625|Secondary|Skeletal Status Improvement|The number of participant who have the skeletal status diagnosed as Osteosclerosis|from baseline to Week 24||||Participants|||Count of Participants
2553704|NCT02770846|Primary|White Esthetic Score|"The White esthetic score (WES) measures the aesthetic appearance of the implant crown.~Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the white esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the implant crown is rated.~The scale consists of 5 variables that are scored 0,1 or 2, the 5 variables scores are combined.~Scale range 0-10, 0 minimum and 10 maximum. A higher score represent a better aesthetic outcome."|5 years|"In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.~1 patient was lost to follow-up in the immediate loading group and 1 in the delayed loading group."|||Score on a scale||Standard Deviation|Mean
2553705|NCT02770846|Primary|Pink Esthetic Score|"The Pink esthetic score (PES) measures the aesthetic appearance of mucosa tissue at the implant site.~Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the pink esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the soft tissue is rated.~The scale consists of 7 variables that are scored 0,1 or 2, the 7 variables scores are combined.~Scale range 0-14, 0 minimum and 14 maximum. A higher score represent a better aesthetic outcome."|After 5 year|"In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.~1 patient was lost to follow-up in the immediate loading group and 1 in the delayed loading group."|||Score on a scale||Standard Deviation|Mean
2553706|NCT02770846|Primary|Change in Level of Marginal Bone|Digital intra-oral periapical radiographs at different time points. The marginal bone level is measured after calibration. Measurements are taken from the implant-abutment junction to the marginal bone level (millimetres). Change in marginal bone level is calculated by comparing bone-to-implant contact level of all appointments to radiographic baseline.|Baseline to 5 years|"In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.~1 patient was lost to follow-up in the immediate loading group and 1 in the delayed loading group."|||mm||Standard Deviation|Mean
2553707|NCT02770846|Primary|White Esthetic Score|"The White esthetic score (WES) measures the aesthetic appearance of the implant crown.~Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the white esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the implant crown is rated.~The scale consists of 5 variables that are scored 0,1 or 2, the 5 variables scores are combined.~Scale range 0-10, 0 minimum and 10 maximum. A higher score represent a better aesthetic outcome."|After 12 months|In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.|||Score on a scale||Standard Deviation|Mean
2553708|NCT02770846|Primary|Oral Health Impact Profile 14 (OHIP-14)|"The Oral Health Impact Profile 14 (OHIP-14) measure oral health related quality of life.~The oral health-related quality of life is calculated using the Swedish validated version of the Oral Health Impact Profile (OHIP-14) questionnaire. The questionnaires are completed at the beginning of the treatment and 12 months after the definitive crown placement.~The scale consists of 14 variables that are scored 1,2,3,4 or 5, the 14 variables scores are combined.~Scale range 14-70, 14 minimum and 70 maximum. A low score represent a better oral health related quality of life."|After 12 months|In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.|||units on a scale||Standard Deviation|Mean
2553709|NCT02770846|Primary|Pink Esthetic Score|"The Pink esthetic score (PES) measures the aesthetic appearance of mucosa tissue at the implant site.~Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the pink esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the soft tissue is rated.~The scale consists of 7 variables that are scored 0,1 or 2, the 7 variables scores are combined.~Scale range 0-14, 0 minimum and 14 maximum. A higher score represent a better aesthetic outcome."|Baseline|In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.|||score on a scale||Standard Deviation|Mean
2553710|NCT02770846|Primary|White Esthetic Score|"The White esthetic score (WES) measures the aesthetic appearance of the implant crown.~Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the white esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the implant crown is rated.~The scale consists of 5 variables that are scored 0,1 or 2, the 5 variables scores are combined.~Scale range 0-10, 0 minimum and 10 maximum. A higher score represent a better aesthetic outcome."|Baseline|In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.|||units on a scale||Standard Deviation|Mean
2553711|NCT02770846|Primary|Oral Health Impact Profile 14|"The Oral Health Impact Profile 14 (OHIP-14) measure oral health related quality of life.~The oral health-related quality of life is calculated using the Swedish validated version of the Oral Health Impact Profile (OHIP-14) questionnaire. The questionnaires are completed at the beginning of the treatment and 12 months after the definitive crown placement.~The scale consists of 14 variables that are scored 1,2,3,4 or 5, the 14 variables scores are combined.~Scale range 14-70, 14 minimum and 70 maximum. A low score represent a better oral health related quality of life."|Pre-surgery||||units on a scale||Standard Deviation|Mean
2553712|NCT02770846|Primary|Pink Esthetic Score|"The Pink esthetic score (PES) measures the aesthetic appearance of mucosa tissue at the implant site.~Intraoral photographs from the aesthetic baseline and follow-up appointments are used to register the pink esthetic score, an objective aesthetic scale were the shape,size,colour and structure of the soft tissue is rated.~The scale consists of 7 variables that are scored 0,1 or 2, the 7 variables scores are combined.~Scale range 0-14, 0 minimum and 14 maximum. A higher score represent a better aesthetic outcome."|After 12 months|In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.|||units on a scale||Standard Deviation|Mean
2553713|NCT02770846|Primary|Change in Level of Marginal Bone|Digital intra-oral periapical radiographs at different time points. The marginal bone level is measured after calibration. Measurements are taken from the implant-abutment junction to the marginal bone level (millimetres). Change in marginal bone level is calculated by comparing bone-to-implant contact level of all appointments to radiographic baseline.|Baseline to 12 months|In the delayed group 1 implant was lost prior to evaluation and therefore not possible to include in this evaluation. Reported as a serious event.|||mm||Standard Deviation|Mean
2553726|NCT02770547|Secondary|Patient Reported Functional Health and Well-being Using 36-item Short Form Health Survey|36-item Short Form Health Survey. All scales are scored 1-100, with 1 being the poorest rating and 100 being the most optimal.|SF-36 questionnaires were administered at weeks 3/6 and 6/6 of the study and compared to baseline values.|Includes all participants that completed the study.|||units on a scale||Standard Deviation|Mean
2553727|NCT02770547|Secondary|Vascular Function Measuring Leg Cutaneous Vascular Conductance - Measured by Laser-doppler Flowmetry of the Skin|Laser-Doppler flowmetry of skin included placement of two heating probes on the anterior portion of the lower leg. The participant sat in a semi-recumbent position for 70 minutes while the temperature of the probe progressed from 33C to 39C at minute 10 and then to 43C at minute 50. Cutaneous vascular conductance was calculated at the average red blood cell flux during the final 2 minutes of the 39C heating portion divided by the mean arterial pressure taken at that time.|Maximal cutaneous vascular conductance values after 40 minutes of localized heating were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.|Includes all participants that completed the study.|||percentage of maximum conductance||Standard Deviation|Mean
2553728|NCT02770547|Secondary|Vascular Function Measured by Ankle-brachial Index - Calculated by Dividing Higher of Posterior Tibial or Dorsalis Pedis Blood Pressure (mmHg) by Higher of Right or Left Arm Systolic Blood Pressure (mmHg)|Ankle-brachial Index|Ankle-brachial index measures were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.|Includes all participants that completed the study.|||ratio||Standard Deviation|Mean
2553729|NCT02770547|Secondary|Vascular Function Assessed by Leg MRI to Measure Peak Blood Flow in Popliteal Artery (ml/s)|Phase contrast magnetic resonance imaging was performed on the leg that the patient indicated to have the most severe claudication. An inflation cuff was placed around the thigh and inflated to 75 mmHg above resting brachial systolic pressure for 5 minutes. After 5 minutes of inflation, the cuff was release and an additional 10 minutes of imaging took place.|Peak flows after post-occlusive reactive hyperemia were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.||||ml/s||Standard Deviation|Mean
2553730|NCT02770547|Primary|Circulating Total Nitrate Levels (mmol)|Blood Draw|Serum total nitrate levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.|One participant was excluded as an outlier from the low heat group. One participant in the high heat group did not have blood draws|||mmol||Standard Deviation|Mean
2553731|NCT02770547|Primary|Circulating Levels of Endothelin-1 (pg/mL)|Blood draw|Serum endothelin-1 levels were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.|One participant was excluded as an outlier from the low heat group. One participant in the high heat group did not have blood draws|||pg/mL||Standard Deviation|Mean
2553732|NCT02770547|Primary|Blood Pressure|Participants have systolic, diastolic and mean blood pressure recording 14 times during baseline, week 3 and week 6 experimental sessions.|Average blood pressure taken every 5 minutes for 70 minutes was obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.|Includes all participants that completed the study.|||mmHg||Standard Deviation|Mean
2553733|NCT02770547|Primary|Exercise Tolerance Assessed by Measuring Distance (m) Walked in 6-minutes|6-minutes walk test|Maximal walking distances on a 6mwt were obtained at weeks 3/6 and 6/6 of the study and compared to baseline values.|Included all participants that completed the study.|||meters||Standard Deviation|Mean
2553734|NCT02770287|Secondary|Vaginal pH|Vaginal pH was obtained at each study visit. The pH is a numeric value from 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 is neutral, lower values are more acidic (value of 0) and higher values more alkaline (value of 14). A healthly vaginal pH has a value of 3.8 to 4.5.|Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57, Follow-up visit - Day 85|Vaginal pH was obtained for 11 subjects at the treatment 1 visit, 9 subjects for the treatment 2 visit, 8 subjects for the treatment 3 visit and only 5 subjects at the follow up visit. No baseline vaginal pH's were obtained.|||score on a scale||Full Range|Mean
2553735|NCT02770287|Secondary|Visual Analog Scale (VAS)|"The subject records their measure of discomfort and pain associated with all treatments of the mons pubis as a vertical line drawn on a 100 mm horizontal line on which the discomfort and pain intensity is represented by a point between the extremes of no pain at all (a value of 0 mm) and worst pain imaginable (a value of 100 mm)."|Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57|Subjects reported 26 VAS scores for treatment 1, treatment 2 and treatment 3 of the mons pubis|||score on a scale||Full Range|Mean
2553736|NCT02770287|Secondary|Visual Analogue Scale (VAS)|"The subject records their measure of discomfort and pain associated with all treatments of the labia as a vertical line drawn on a 100 mm horizontal line on which the discomfort and pain intensity is represented by a point between the extremes of no pain at all (a value of 0 mm) and worst pain imaginable (a value of 100 mm)."|Treatment 1 - Day 1, Treatment 2 - Day 29, Treatment 3 - Day 57|Subjects reported 26 VAS scores for treatment 1, treatment 2 and treatment 3 of the labia|||score on a scale||Full Range|Mean
2553737|NCT02770287|Primary|General Skin Appearance of Mons Pubis and Labia|Improvement in general skin appearance at follow-up visit 3 as compared to baseline as assessed by independent blinded evaluator by photographic assessment, utilizing the Global Aesthetic Improvement Scale (GAIS) where 3 = very much improved, 2 = much improved, 1 = improved, 0 = no change, -1 = worse, -2 = much worse and -3 = very much worse where higher scores indicate a better outcome.|Baseline - Day 1, Follow-up visit - Day 85||||Participants|||Count of Participants
2553738|NCT02770248|Secondary|Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4|IOP (fluid pressure inside the eye) was measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4|Full Analysis Set|||mmHg||95% Confidence Interval|Least Squares Mean
2553739|NCT02770248|Secondary|Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4|IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (10 PM through 6 AM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4|Full Analysis Set|||mmHg||95% Confidence Interval|Least Squares Mean
2553740|NCT02770248|Secondary|Least Squares Mean Change From Baseline in Daytime IOP at Week 4|IOP (fluid pressure inside the eye) was measured in mmHg. Change was calculated by taking the change from baseline at each time point (8 AM through 8 PM) and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4|Full Analysis Set|||mmHg||95% Confidence Interval|Least Squares Mean
2553741|NCT02770248|Primary|Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4|IOP (fluid pressure inside the eye) was measured in millimeters of mercury (mmHg). Change was calculated by taking the change from baseline at each time point and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4|Full Analysis Set|||mmHg||95% Confidence Interval|Least Squares Mean
2553742|NCT02770014|Secondary|Positive Predictive Value (PPV) And False Negative Rate Of Plasma Genotyping|Concordance between results of plasma genotyping and tumor genotyping, among patients with tissue available for standard genotyping|PPV and False Negative Rate can be assessed when plasma and tissue results are available for each patient; average plasma result turnaround time was 4 days, versus average of 20 days for tissue result turnaround time.|35 of the 42 participants with plasma genotyping results also had tumor genotyping results available, so PPV and false negative rate could be assessed in these 35 participants.|||percentage|||Number
2553743|NCT02770014|Secondary|Turnaround Time|The turnaround time from study registration to treatment initiation was recorded for the plasma genotyping strategy versus standard tumor genotyping. For rapid plasma genotyping, turnaround time is the time between ordering plasma genotyping and obtaining results; this time period was compared to the turnaround time of obtaining the tumor genotyping results.|Maximum 38 days|A total of 42 participants had plasma genotyping results available (1 of the 43 enrolled participants did not have plasma genotyping).|||days||Full Range|Median
2553744|NCT02770014|Primary|Overall Response Rate|Number of participants who were alive with evidence of complete or partial response, evaluated using RECIST 1.1 criteria. Patients that underwent rapid plasma genotyping and had an EGFR mutation and who were treated with erlotinib were included in this calculation.|From date of erlotinib initiation until the date of first documented disease progression or date of death from any cause, whichever came first. ORR was assessed up to 21 months after erlotinib initiation.|A total of 6 participants were treated with erlotinib on study.|||Participants|||Count of Participants
2553745|NCT02769858|Primary|Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 5 Weeks|Onset of melatonin in dim light conditions as measured in saliva (also called DLMO) Time of DLMO is measured in clock time, so a positive number in change would represent a later onset of melatonin and a negative number represents an earlier onset of melatonin|After five weeks of light therapy||||minutes||Standard Deviation|Mean
2553746|NCT02769858|Primary|Change From Baseline Score of the Edinburgh Postnatal Depression Scale (EPDS) at 5 Weeks|Self-report of depression symptoms. The Edinburgh Postnatal Depression scale is scored from 0 to 30 where 0 is no depression and 30 is most severe depression.|After five weeks of light therapy||||EPDS score||Standard Deviation|Mean
2553747|NCT02769858|Primary|Change From Baseline Score of the Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) at 5 Weeks|Clinician-rated depression symptom severity measure; Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) (29 item version) measures depressive symptoms on a continuous scale. Higher scores indicate worse outcomes. Scores can range from 0 -73, where 0 means no depression, and 73 is the greatest possible depression. Generally scores of 20 or higher represent clinical depression|After five weeks of light therapy||||SIGH-SAD score||Standard Deviation|Mean
2553748|NCT02769702|Secondary|Change in Baseline in Eye With Uveitis of Anterior Chamber Protein Graded 0-4 on a Likert Scale Determined by Slit Lamp Evaluation|standard assessment of uveitis activity. Scores were assessed using a Likert scale using 0 to 4, higher score reflects more protein.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2553749|NCT02769702|Primary|Change From Baseline in Eye With Uveitis of Anterior Chamber Cellularity Graded From 0-4 on a Likert Scale Determined by Slit Lamp Examination|standard assessment of uveitis activity. Scores were assessed using a Likert scale using 0 to 4, higher score reflects more cellularity.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2553750|NCT02769442|Secondary|Number of Participants With Blood Visible at Site of Insertion|Compare the frequency of bleeding near the insertion site|Within first minute of IV access||||participants|||Number
2553751|NCT02769442|Primary|Number of Participants With First-skin Puncture Success|"First attempt success, defined as one skin puncture (redirection permitted) which allows for completion of a blood draw and/or flush without extravasation.~Gauge size~Patient prior history of difficult IV access~Operator type (ED Technician/Registered Nurse/Physician Assistant/Nurse Practitioner/Resident/Attending)~Operator years of experience with IV access~Type of catheter used"|Within first minute of IV access||||Participants|||Count of Participants
2553752|NCT02769312|Secondary|Change in Social/Occupational Functioning (QOL/SOF) Due to TBS Treatment|"Change measured using the social/occupational functioning assessment scale (SOFAS).~Clinician rating of social & occupational functioning. Scale of 0-100 with higher scores indicating higher functioning."|Baseline and end of double-blind period (2 weeks)|Included all subjects who were randomized. Primary outcomes were measured using analysis of variance to compare groups at the end of the 2-week double blind phase. Missing data was addressed using multiple imputation, with 20 imputations or maximum likelihood parameter estimation in mixed model analyses.|||score on a scale||Standard Deviation|Mean
2553753|NCT02769312|Secondary|Change in PTSD Symptom Severity|"Change in PTSD symptoms measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).~The CAPS-5 is a structured interview to measure for PTSD symptom change and presence/absence of PTSD, items rated 0 = 'absent' to 4 = 'extreme/incapacitating,' total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Higher scores indicate more severe PTSD symptoms."|Baseline and end of double-blind period (2 weeks)|Included all subjects who were randomized. Primary outcomes were measured using analysis of variance to compare groups at the end of the 2-week double blind phase. Missing data was addressed using multiple imputation, with 20 imputations or maximum likelihood parameter estimation in mixed model analyses.|||score on a scale||Standard Deviation|Mean
2553754|NCT02769312|Secondary|Change in Quality of Life Due to TBS Treatment|"Change in the quality of life, using the quality of life questionnaire QLESQ - Quality of Life Enjoyment and Satisfaction Questionnaire (General Quality of Life Index).~A self-report scale covering multiple domains (physical health, subjective feelings, leisure time activities, social relationships, treatment satisfaction) The General Quality of Life Index took the mean of all domains. Scores range from 0-5, with higher scores indicating higher quality of life."|Baseline and end of double-blind period (2 weeks)|Data was analyzed in an intent-to-treat fashion. Primary outcomes were measured using analysis of variance to compare groups at the end of the 2-week double blind phase. Missing data was addressed using multiple imputation, with 20 imputations or maximum likelihood parameter estimation in mixed model analyses.|||score on a scale||Standard Deviation|Mean
2553755|NCT02769312|Primary|Number of Participants Retained, a Measure of Acceptability of TBS Procedures|Measurement of TBS acceptability, measured using participant retention rates (all-cause discontinuation)|2 weeks|Data was analyzed in an intent-to-treat fashion, defined as participants that were randomized and received at least one iTBS session.|||Participants|||Count of Participants
2553756|NCT02769247|Post-Hoc|Assessment of Analgesic Use in Mirena IUD Patients Within 24 Hrs When Queried at Day 30|Assessment at day 30 if patients used analgesics within 24 hrs post Mirena IUD insertion|30 days|These participants reflect the number of patients that were able to be successfully contacted approximately 30 days after their IUD insertion.|||Participants|||Count of Participants
2553757|NCT02769247|Post-Hoc|Paragard IUD Medication Use 30 Day Assessment|Assessment of whether patient had used analgesics in first 24 hrs after Paragard IUD insertion. Quantified yes or no.|30 days|These participants reflect the number of patients that were able to be successfully contacted approximately 30 days after their IUD insertion.|||Participants|||Count of Participants
2553758|NCT02769247|Post-Hoc|Paragard vs Mirena IUD Pain Medication Use|"Patient's recall of self administered pain medication within 24 hours after IUD insertion as reported 30 days post insertion. Denoted as yes  or no. This measure was to assess whether any difference in pain perception between patients receiving different types of IUD."|30 days post insertion|These participants reflect the number of patients that were able to be successfully contacted approximately 30 days after their IUD insertion.|||Participants|||Count of Participants
2553759|NCT02769247|Post-Hoc|Paragard vs Mirena IUD|difference in pain ratings during IUD insertion as assessed by visual analog scale by both patient (0-10 with 10 being the most pain, 0 no pain) within 30 minutes post insertion classified by IUD type. This measure is made to address whether type of IUD affected pain perception.|visual analog scale as assessed by patient and physician both within 30 minutes post insertion||||units on a scale||Standard Error|Mean
2553760|NCT02769247|Secondary|Perceived Pain 30 Days Post Insertion|survey patient 30 days later to determine her recollection of pain during insertion (0-10); 10 being the most pain. One patient had no IUD initially inserted and was not included; each arm had patients lost to follow up (3 in placebo arm, 2 in naproxen arm, 4 in placebo/oral medication arm).|30 days post IUD insertion||||units on a scale||Standard Error|Mean
2553761|NCT02769247|Secondary|Difficulty IUD Insertion|"as rated by the physician. Very easy/easy were rated as easy whereas difficult/very difficult is difficult."|within 30 minutes of IUD insertion|Overall number of participants analyzed for placebo arm is different due to 1 of the subjects not able to have their IUD inserted due to difficulty of procedure. They were included in this analysis as an attempt had been made to insert device.|||Participants|||Count of Participants
2553762|NCT02769247|Secondary|Patient Satisfaction With IUD|Patient satisfaction as rated on a 1-5 scale 30 days post insertion. Scale of 5 means highly satisfied, 1 means unsatisfied.|30 days post insertion||||units on a scale||Standard Error|Mean
2553763|NCT02769247|Secondary|Physician Perceived Pain Control During IUD Insertion|visual analog scale (0-3) as assessed by physician within 30 minutes after IUD insertion Scale is from a minimum of 0, with maximum of 3 with higher scores denoting more pain|within 30 minutes after IUD insertion|There was one patient in placebo arm unable to have her IUD placed due to difficulty with insertion. She was removed from the analysis.|||units on a scale||Standard Deviation|Mean
2553764|NCT02769247|Primary|Pain Control With IUD Insertion|visual analog scale (0-10) as assessed by patient within 30 minutes after IUD insertion. Scale is from a minimum of 0, with maximum of 10 with higher scores denoting more pain|within 30 minutes after IUD insertion|There is one patient in placebo arm that did not receive IUD due to difficulty with insertion.|||units on a scale||Standard Error|Mean
2553765|NCT02769065|Secondary|Ratio of Geometric Mean of AUC(0-24) for Donepezil After 21 Daily Doses of TAK-071|A linear mixed effect model on the natural log-transformed parameters was performed with day as a fixed effect and participant as a random effect. Ratio is the exponentiated geometric mean value Day 21/Day -1 on the original scale.|Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.|||Ratio||90% Confidence Interval|Number
2553766|NCT02769065|Secondary|Ratio of Geometric Mean of Cmax for Donepezil After 21 Daily Doses of TAK-071|A linear mixed effect model on the natural log-transformed parameters was performed with day as a fixed effect and participant as a random effect. Ratio is the exponentiated geometric mean value Day 21/Day -1 on the original scale.|Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.|||Ratio||90% Confidence Interval|Number
2553767|NCT02769065|Secondary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Donepezil||Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553768|NCT02769065|Secondary|Cmax: Maximum Observed Plasma Concentration for Donepezil MRD Non-Japanese Participants||Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||ng/mL||Standard Error|Mean
2553769|NCT02769065|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Donepezil MRD Non-Japanese Participants||Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||hours||Full Range|Median
2553770|NCT02769065|Secondary|Ratio of CSF AUC(0-36) to the Plasma AUC(0-36) for TAK-071||Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose Cohort 9|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.|||Ratio||Standard Deviation|Mean
2553771|NCT02769065|Secondary|Ratio of CSF AUC(0-12) to the Plasma AUC(0-12) for TAK-071||Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.|||Ratio||Standard Deviation|Mean
2553772|NCT02769065|Secondary|CSF AUC(0-36): Area Under the CSF Concentration-time Curve From Time 0 to 36 Hours for TAK-071||Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.|||h*ng/mL||Standard Deviation|Mean
2553773|NCT02769065|Secondary|CSF AUC(0-12): Area Under the CSF Concentration-time Curve From Time 0 to 12 Hours for TAK-071||Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.|||h*ng/mL||Standard Deviation|Mean
2553774|NCT02769065|Secondary|CSF Cmax: Maximum Observed Concentration in Cerebrospinal Fluid (CSF) for TAK-071||Pre-dose on Day 28 and at multiple time points (up to 36 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.|||ng/mL||Standard Deviation|Mean
2553775|NCT02769065|Secondary|CSF Cmax: Maximum Observed Concentration in Cerebrospinal Fluid (CSF) for TAK-071||Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||ng/mL||Standard Deviation|Mean
2553776|NCT02769065|Secondary|CLR: Renal Clearance for TAK-071 MRD Japanese Participants||Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose and pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||L/h||Standard Deviation|Mean
2553777|NCT02769065|Secondary|CLR: Renal Clearance for TAK-071 MRD Non-Japanese Participants||Pre-dose on Days 1 and 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8 and Pre-dose on Days 1 and 28 multiple time points (up to 96 hours) post-dose for Cohort 9|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.|||L/h||Standard Deviation|Mean
2553778|NCT02769065|Secondary|CLR: Renal Clearance for TAK-071 SRD Non-Japanese Participants||Pre-dose on Day 1 and at multiple time points [up to 96 hours] post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Measurable TAK-071 was not detected in urine for Cohort 1 (TAK-071 1 mg). Here, number analyzed is the number of participants with data available for analysis at the given time-point.|||L/h||Standard Deviation|Mean
2553779|NCT02769065|Secondary|Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants||Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose and pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||fraction of drug excreted||Standard Deviation|Mean
2553780|NCT02769065|Secondary|Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants||Pre-dose on Days 1 and 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8 and Pre-dose on Days 1 and 28 and multiple time points (up to 96 hours) post-dose for Cohort 9|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.|||fraction of drug excreted||Standard Deviation|Mean
2553781|NCT02769065|Secondary|Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants||Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Measurable TAK-071 was not detected in urine for Cohort 1 (TAK-071 1 mg). Here, number analyzed is the number of participants with data available for analysis at the given time-point.|||fraction of drug excreted||Standard Deviation|Mean
2553782|NCT02769065|Secondary|AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants||Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose and pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||mg||Standard Deviation|Mean
2553783|NCT02769065|Secondary|AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants||Pre-dose on Day 1 and 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8, and pre-dose on Day 1 and 28 and multiple time points (up to 96 hours) post-dose for Cohort 9|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.|||mg||Standard Deviation|Mean
2553784|NCT02769065|Secondary|AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants||Pre-dose on Day 1 and at multiple time points [up to 96 hours] post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Measurable TAK-071 was not detected in urine for Cohort 1 (TAK-071 1 mg). Here, number analyzed is the number of participants with data available for analysis at the given time-point.|||mg||Standard Deviation|Mean
2553785|NCT02769065|Secondary|Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Non-Japanese Participants||Pre-dose on Day 21 and at multiple time points [up to 24 hours] post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||Ratio||Standard Deviation|Mean
2553786|NCT02769065|Secondary|Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Japanese Participants||Pre-dose on Day 28 and at multiple time points [up to 24 hours] post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||Ratio||Standard Deviation|Mean
2553787|NCT02769065|Secondary|Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Non-Japanese Participants||Pre-dose on Day 21 and at multiple time points [up to 24 hours] post-dose for Cohorts 7 and 8 and Pre-dose on Day 28 and at multiple time points (up to 36 hours) post-dose for Cohort 9|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||Ratio||Standard Deviation|Mean
2553788|NCT02769065|Secondary|Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Non-Japanese Participants||Pre-dose on Day 21 and at multiple time points [up to 24 hours] post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||Ratio||Standard Deviation|Mean
2553789|NCT02769065|Secondary|Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Japanese Participants||Pre-dose on Day 28 and at multiple time points [up to 24 hours] post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||Ratio||Standard Deviation|Mean
2553790|NCT02769065|Secondary|Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Non-Japanese Participants||Pre-dose on Day 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8 and Pre-dose on Day 28 and at multiple time points (up to 36 hours) post-dose for Cohort 9|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||Ratio||Standard Deviation|Mean
2553791|NCT02769065|Secondary|Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants TAK-071 + Donepezil||Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||L||Standard Deviation|Mean
2553792|NCT02769065|Secondary|Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect||Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||L||Standard Deviation|Mean
2553793|NCT02769065|Secondary|Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants||Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||L||Standard Deviation|Mean
2553794|NCT02769065|Secondary|CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil||Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||L/h||Standard Deviation|Mean
2553795|NCT02769065|Secondary|CL/F: Apparent Clearance After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect||Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||L/h||Standard Deviation|Mean
2553796|NCT02769065|Secondary|CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants||Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||L/h||Standard Deviation|Mean
2553797|NCT02769065|Secondary|Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil||Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||hours||Full Range|Median
2553798|NCT02769065|Secondary|Terminal Disposition Phase Half-life (t1/2z) for TAK-071 Relative Bioavailability and Food Effect||Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||hours||Full Range|Median
2553799|NCT02769065|Secondary|Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants||Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||hours||Full Range|Median
2553800|NCT02769065|Secondary|AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil||Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553801|NCT02769065|Secondary|AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 Relative Bioavailability and Food Effect||Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553802|NCT02769065|Secondary|AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese||Pre-dose on Day 1 and at multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553803|NCT02769065|Secondary|AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Japanese Participants||Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose and Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553804|NCT02769065|Secondary|AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants||Pre-dose on Day 1 and multiple timepoints (up to 24 hrs) post-dose for Cohorts 7 and 8 and Pre-dose on Day 1 and multiple timepoints (up to 96 hrs) post-dose for Cohort 9|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553805|NCT02769065|Secondary|AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants||Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553806|NCT02769065|Primary|AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants TAK-071 + Donepezil||Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553807|NCT02769065|Primary|AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants||Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553808|NCT02769065|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil||Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553809|NCT02769065|Primary|AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071 Relative Bioavailability and Food Effect||Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553810|NCT02769065|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 21]||Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553811|NCT02769065|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 1]||Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553812|NCT02769065|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 28]||Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553813|NCT02769065|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 8]||Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553814|NCT02769065|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 1]||Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553815|NCT02769065|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 28]||Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553816|NCT02769065|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 8]||Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553817|NCT02769065|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 1]||Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553818|NCT02769065|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 21]||Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553819|NCT02769065|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1]||Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553820|NCT02769065|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants||Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||h*ng/mL||Standard Deviation|Mean
2553821|NCT02769065|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil||Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||ng/mL||Standard Deviation|Mean
2553822|NCT02769065|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-071 Relative Bioavailability and Food Effect||Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||ng/mL||Standard Deviation|Mean
2553823|NCT02769065|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 21]||Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||ng/mL||Standard Deviation|Mean
2553824|NCT02769065|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 1]||Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||ng/mL||Standard Deviation|Mean
2553825|NCT02769065|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 28]||Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||ng/mL||Standard Deviation|Mean
2553826|NCT02769065|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 8]||Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||ng/mL||Standard Deviation|Mean
2553827|NCT02769065|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 1]||Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||ng/mL||Standard Deviation|Mean
2553828|NCT02769065|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 28]||Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||ng/mL||Standard Deviation|Mean
2553829|NCT02769065|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 8]||Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||ng/mL||Standard Deviation|Mean
2553830|NCT02769065|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 1]||Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||ng/mL||Standard Deviation|Mean
2553831|NCT02769065|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 21]||Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||ng/mL||Standard Deviation|Mean
2553832|NCT02769065|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1]||Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||ng/mL||Standard Deviation|Mean
2553833|NCT02769065|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants||Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||ng/mL||Standard Deviation|Mean
2553834|NCT02769065|Primary|Tmax: Time of First Occurrence of Cmax for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil||Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||hours||Full Range|Median
2553835|NCT02769065|Primary|Tmax: Time of First Occurrence of Cmax for TAK-071 Relative Bioavailability and Food Effect||Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||hours||Full Range|Median
2553836|NCT02769065|Primary|Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 21]||Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||hours||Full Range|Median
2553837|NCT02769065|Primary|Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 1]||Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||hours||Full Range|Median
2560618|NCT02662569|Primary|Percent Change From Baseline in LDL-C at Week 12||Baseline and week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2553838|NCT02769065|Primary|Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 28]||Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||hours||Full Range|Median
2553839|NCT02769065|Primary|Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 8]||Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||hours||Full Range|Median
2553840|NCT02769065|Primary|Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 1]||Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||hours||Full Range|Median
2553841|NCT02769065|Primary|Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 28]||Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||hours||Full Range|Mean
2553842|NCT02769065|Primary|Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 8]||Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||hours||Full Range|Median
2553843|NCT02769065|Primary|Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 1]||Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||hours||Full Range|Mean
2553844|NCT02769065|Primary|Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 21]||Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||hours||Full Range|Median
2553845|NCT02769065|Primary|Tmax: Time of First Occurrence of Cmax for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1]||Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose|PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||hours||Full Range|Median
2553846|NCT02769065|Primary|Tmax: Time of First Occurrence of Cmax for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants||Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose|Pharmacokinetic (PK) set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.|||hours||Full Range|Median
2553847|NCT02769065|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose|A standard 12-lead electrocardiogram (ECG) was performed. The percentage of participants with markedly abnormal ECG findings during the study.|Day 1 up to Day 41|SAS included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2553848|NCT02769065|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose|Vital Sign measurements included systolic blood pressure (SBP), diastolic blood presssure (DBP), pulse, temperature, orthostatic SBP, orthostatic DBP and orthostatic pulse.|Day 1 up to Day 41|SAS included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2553849|NCT02769065|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose|Clinical laboratory tests included serum chemistry, hematology, coagulation and urinalysis. ULN=upper limit of normal range.|Day 1 up to Day 41|SAS included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2553850|NCT02769065|Primary|Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs or gets worse after receiving study drug.|Day 1 up to Day 41|Safety Analysis Set (SAS) included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2553851|NCT02768870|Secondary|Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days|Subject's freedom from Serious Adverse Events at >30 days post-implant. Time to events were estimated by Kaplan-Meier method.|6 months, 12 months, 18 months, and 24 months|This outcome is reported for subjects who received the Harpoon Medical Device where data is available.|||percentage of subjects|||Number
2553852|NCT02768870|Secondary|Subject's Severity of Mitral Regurgitation Over Time|"Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. The numbers on the scale are reflected as follows: 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak.~Higher numbers on the scale show a worsening outcome."|6 months, 12 months, 18 months, and 24 months|This outcome is reported for subjects who received the Harpoon Medical Device where data is available.|||Participants|||Count of Participants
2553853|NCT02768870|Primary|Subject's Serious Adverse Events (SAE) Through Discharge|Number of Participants experiencing a Serious Adverse Event (SAE) through time of Discharge.|Discharge, an average of 5 days post implant|This outcome is reported for subjects who received the Harpoon Medical Device where data is available.|||Participants|||Count of Participants
2553854|NCT02768870|Primary|Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 30 Days|Subject's freedom from Serious Adverse Events during the ePTFE implantation procedure and at 30 days follow-up. Time to events were estimated by Kaplan-Meier method.|Procedure and 30 days|This outcome is reported for subjects who received the Harpoon Medical Device where data is available.|||percentage of subjects|||Number
2560619|NCT02662569|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2553855|NCT02768870|Primary|Subject's Procedural Success During the First 30 Days|Procedural success was defined as the patient leaving the operating room with a successful implant of one or more ePTFE cords on the mitral valve and reduced mitral regurgitation from severe to </=moderate at the conclusion of the procedure and at 30 days post-procedure.|Procedure and 30 days|This outcome is reported for enrolled subjects where data is available.|||Participants|||Count of Participants
2553856|NCT02768753|Secondary|Swallowing Evaluation|"The patient sat upright and drank 30 ml warm boiled water to observe the time required and the cough.~score (excellent) can swallow water smoothly once~score (good) more than 2 times, can swallow without coughing~score (middle) can swallow once, but have a choking cough~score (may) more than 2 times swallowing, but with choking cough~score (difference) frequent cough, not all swallowing Calculate the average value for statistical analysis"|8 a.m. on the 3rd day after operation||||score||Standard Deviation|Mean
2553857|NCT02768753|Secondary|Subjective Voice|We have developed a questionnaire with a total of 30 questions, each with a score of 4, and the patients scored according to their own situation. The highest score of the questionnaire is 120, the lowest score is 0, the best, the score is 0-30, 30-60 is good, 60-90 is normal, 90-120 is poor.|After operation 8 a.m. on the 7th day||||score||Standard Deviation|Mean
2553858|NCT02768753|Primary|Cosmetic Outcomes|The satisfaction with cosmetic outcomes was analyzed quantitatively using a scoring system that ranged from 1 to 4(1, extremely; 2, fairly; 3, normal; 4: not at all) that was rated by patients at the outpatient clinic 3 months after the operation.|3 months after surgery||||score||Standard Deviation|Mean
2553859|NCT02768753|Primary|Change of VAS Pain Scores for the First 24 Hours|"The visual analogue scale is utilized to assess the postoperative pain change for the first 24 hours.Using a 10cm straight line, one end is marked 0 for pain free and the other end is marked 10 for unbearable pain. The pain intensity of the patient's own feelings was marked on a straight line, and the length from 0 to the marked point represented the pain level of the patient. The evaluation criteria of VAS were as follows: 0 for pain, 3 for mild pain, 4 to 6 for moderate pain and 7 to 10 for severe pain.Lower values represent better outcomes, higher values represent worse outcomes."|The pain scores of 2pm, 10pm and 6am on the first day after operation were evaluated.The mean values were calculated and recorded.||||score||Standard Deviation|Mean
2553860|NCT02768558|Secondary|Progression-Free Survival by PD-L1 Status||From registration to study termination. Maximum follow-up was 14.9 months.|Data is not reported because the primary endpoints were not determined to have positive results. [Per the protocol, this subgroup analysis was to occur only if either of the primary endpoints were determined to have positive results.]||||||
2553861|NCT02768558|Secondary|Overall Survival by PD-L1 Status||From registration to study termination. Maximum follow-up was 14.9 months.|Data is not reported because the primary endpoints were not determined to have positive results. [Per the protocol, this subgroup analysis was to occur only if either of the primary endpoints were determined to have positive results.]||||||
2553862|NCT02768558|Secondary|Percentage of Participants With Deterioration in Functional Assessment of Cancer Therapy - Trial Outcome Index for Lung Cancer (FACT-TOI) at 15 Months|FACT-TOI is a measure of 21 items that sum the functional well being (FWB), physical well being (PWB), and the lung cancer subscale (LCS) of the Functional Assessment of Cancer Therapy - Lung (FACT-L) QOL instrument, used for measuring QOL in patients with lung cancer. All items are rated on a 5 item (point) Likert Scale, from 0 (not at all) to 4 (very much). FACT-TOI is scored by summing the individual scale scores, with higher scores indicating better quality of life. Deterioration was defined as a decrease of 5 points or more from baseline.|Baseline and 15 months|No participants had a 15-month FACT-TOI assessment||||||
2553863|NCT02768558|Secondary|Number of Participants With Grade 3+ Adverse Events|Adverse events (AE) are graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From registration to study termination. Maximum follow-up was 14.9 months.|Eligible participants|||Participants|||Count of Participants
2553864|NCT02768558|Primary|Progression-Free Survival (PFS)|"Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions at any location. Progression was to be determined by an independent radiology review committee using scans submitted to a central location.~Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored) and was to be estimated by the Kaplan-Meier method."|From registration to study termination. Maximum follow-up was 14.9 months.|Central review of imaging to determine progression was not performed due to early study closure therefore progression (and hence progression-free survival) could not be determined.||||||
2553865|NCT02768558|Primary|Overall Survival (OS)|Survival time is defined as time from registration to date of death from any cause and was to be estimated by the Kaplan-Meier method. Given the limited follow-up due to early closure and termination of data collection, only the number of patients last reported to be alive at time of study termination is reported and no statistical testing was done.|From registration to study termination. Maximum follow-up was 14.9 months.|Eligible participants|||Participants|||Count of Participants
2553866|NCT02768194|Secondary|Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application|Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded|Baseline, Day 1, 4, and 10|PP Population was the primary analysis population, defined as those participants in the ITT (Intent to treat) population for whom all post baseline scanning electron microscopy (SEM) image scores were not deemed to be affected by protocol violations.|||Score on a scale||Standard Deviation|Mean
2553883|NCT02767765|Primary|Percentage of Participants With Response to Treatment|Response to treatment was defined as an increase of greater than (>) 1 gram per deciliter (g/dL) in hemoglobin level (irrespective of the need of transfusion) from Baseline value at Week 4.|Week 4|The intent-to-treat (ITT) analysis population included all enrolled participants who received study medication for at least 2 weeks.|||percentage of participants|||Number
2553867|NCT02768194|Primary|Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application|Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded|Baseline and Day 8|Per protocol (PP) Population was the primary analysis population, defined as those participants in the ITT (Intent to treat) population for whom all post baseline scanning electron microscopy (SEM) image scores were not deemed to be affected by protocol violations.|||Score on a scale||Standard Deviation|Mean
2553868|NCT02768129|Primary|Pain Anxiety Symptom Scale Rating|The Pain Anxiety Symptom Scale (PASS-20) is a validated measure of pain-related avoidance and fear. Total score ranges 0-100. Higher scores indicate greater pain anxiety.|8 weeks total||||score on a scale||Standard Deviation|Mean
2553869|NCT02768129|Primary|West Haven-Yale Multidimensional Pain Inventory (General Activity Subscale) Rating|Subscale C of the West Haven-Yale Multidimensional Pain Inventory (WHY-MPI) is a validated measure of chronic pain's effects on functioning. Ranging from 0-108, higher scores indicate more activity (better outcome).|8 weeks total||||score on a scale||Standard Deviation|Mean
2553870|NCT02768103|Secondary|Fine-wire Electromyography of Transferred Brachioradialis Muscle (to Paralyzed Thumb Flexor)|EMG signal recorded from fine-wire (intramuscular) electrodes normalized to a maximum voluntary contraction|after 10 week home exercise program with task-based training||||percentage of Max Br Contraction||Standard Deviation|Mean
2553871|NCT02768103|Primary|Functional MRI BOLD Signal From Motor Cortex|A block design with 10 seconds of rest alternating with 10 seconds of functional movement for 6 minutes will be followed. Participants have visual cues to instruct them in the timing and sequence of the tasks to be performed. Scan time to include a session of elbow flexion and a session for pinch is about 20 minutes. The main outcome measures for the fMRI data will be brain activation defined by intensity and cluster size in response to performing elbow flexion and pinch. Second level analyses will be mixed models effects derived using FSL FLAME for within subjects (pre to post intervention) as well as cross-sectional (non impaired vs. SCI-ns; SCI-ns vs. SCI+TT) individual models (with outlier deweighting and standard settings).|after 10 week home exercise program with task-based training||2020-06-30|06/2020||||
2553872|NCT02768103|Primary|Pinch Force|Pinch force recorded in newtons from force sensor mounted to a custom grip|after 10 weeks home exercise program with task-based training||||newtons||Standard Deviation|Mean
2553873|NCT02767947|Primary|Circulating Plasma Concentration of Luliconazole at Day 7 (6 Hours Post-Dose)|Plasma levels of luliconazole were obtained at steady-state (within 15 minutes prior to the final dose of the study drug on Day 7) and approximately the tmax (6 hours after the final dose of study drug on Day 7).|6 hours after the final dose of the drug on Day 7|PK population included all randomized participants who received at least 1 application of study drug, and from whom blood samples were obtained for plasma level analysis both prior to (within 15 minutes) and 6 hours after the final dose (on Day 7).|||ng/mL||Standard Deviation|Mean
2553874|NCT02767947|Primary|Circulating Plasma Concentration of Luliconazole at Day 7 (Pre-Dose)|Plasma levels of luliconazole were obtained at steady-state (within 15 minutes prior to the final dose of the study drug on Day 7) and approximately the time of maximum concentration (tmax) (6 hours after the final dose of study drug on Day 7).|Pre-dose (within 15 minutes prior to the final dose of the drug) on Day 7|PK population included all randomized participants who received at least 1 application of study drug, and from whom blood samples were obtained for plasma level analysis both prior to (within 15 minutes) and 6 hours after the final dose (on Day 7).|||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
2553875|NCT02767843|Secondary|Complete Response|snoring for < 5% of total sleep tim|one night|||||||
2553876|NCT02767843|Primary|Adverse Events|all adverse events|one night|All four participants were analyzed for adverse events. No participants could be analyzed for efficacy outcomes because of technical difficulties with the measurement instruments.|||Participants|||Count of Participants
2553877|NCT02767843|Primary|Response|snoring decreased by <50% from baseline|one night|Technical problems with the measurement instruments meant that no analyzable data were collected.||||||
2553878|NCT02767765|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Score at Week 4|FACT-An comprises of 4 subscales of 27-item (FACT-General scale [FACT-G]): physical well-being, social/family well-being, emotion well-being, functional well-being, and an additional concerns anemia subscale. All questions are rated on a scale from 0 to 4, where higher scores indicate more impact on quality of life. The physical well-being subscale consists of 7 questions with score range from 0-28; social/family well-being subscale consists of 7 questions with score range from 0-28; emotion well-being subscale consists of 6 questions with score range from 0-24; functional well-being subscale consists of 7 questions with score range from 0-28; anemia subscale consist of 20 questions with score range from 0-80. Total FACT-An score ranges from 0-188.|Baseline, Week 4|"All enrolled participants who completed the questionnaire at baseline were included in the analysis. Here, n represents number of participants evaluable for the specified category."|||units on a scale||Standard Deviation|Mean
2553879|NCT02767765|Secondary|Percentage of Participants Who Required Transfusion||Baseline, Week 2, Week 4|ITT analysis population|||percentage of participants|||Number
2553880|NCT02767765|Secondary|Percentage of Participants With No Response to Treatment After 4 Weeks of Study Treatment|"No Response to treatment after 4 weeks was defined as meeting any of the following criteria: <1 g/dL increase in hemoglobin level or hemoglobin level <8.5 g/dL or need of transfusion. If a participant had an increase in hemoglobin level of >1 g/dL but required transfusion then the participant is considered as Non- Responder."|Week 4|ITT analysis population|||percentage of participants|||Number
2553881|NCT02767765|Secondary|Percentage of Participants With Response to Treatment After 2 Weeks of Study Treatment|Response to treatment after 2 weeks of treatment was defined as presence of any of the following criteria: reticulocytes >40000 per microliter or >25% increase in soluble transferrin receptor or >0.5 g/dL increase in hemoglobin level.|Week 2|ITT analysis population|||percentage of participants|||Number
2553882|NCT02767765|Secondary|Time to Response|Time to response was defined as the time between the start of treatment and the increase in hemoglobin level >1 g/dL compared to baseline hemoglobin level. Time to response was estimated using Kaplan Meier method.|Baseline up to Week 4|ITT analysis population|||days||95% Confidence Interval|Median
2553884|NCT02767609|Primary|Regional Cerebral Blood Flow Values of the Brain Measured Using Pseudo-continuous Arterial Spin Labeling (pCASL) MRI.|The relative cerebral blood flow (CBF) in frontal, parietal, occipital gray matter and white matter regions, basal ganglia, thalami, and cerebellum will be measured using region of interest analysis to determine institutional normative values for healthy subjects.|single encounter|control|||ml/100g/min||Standard Deviation|Mean
2553885|NCT02767531|Primary|Fasting Serum Triglycerides|Fasting blood samples were collected on three consequetive days at the end of each three month period. Mean values of the three days were calculated.|3 days|The patients were randomized to receive 3 months of orlistat or no therapy (off), then crossed over to the other arm, and this sequence was then repeated. Because only 2 patients participated, the results are provided per sequence and not per intervention.|||mg/dL||Full Range|Mean
2553886|NCT02767427|Primary|Number of Patients With Cutaneous Bacterial Load After Surgery|All specimens were taken by a sterile BD E-Swab. All samples will be sent immediately after acquisition to the microbiology lab for analysis within four hours.|Pre-Surgery and Post Surgery, up to 4 hours||||Participants|||Count of Participants
2553887|NCT02767388|Primary|Change From Baseline CDA Amplitude at 1- and 3- Months|Electrophysiological component that measures online storage load|Collected at Study Induction, 1 month after Study Induction, 3 months after Study Induction|The number analyzed differed between rows due to participant dropout from Month-1 to Month-3. Differences in number analyzed and numbers in the Participant Flow module were due to patient dropout and either: (1) a minority of patients requesting not to complete testing; or (2) difficulties with electrophysiology or stimulus presentation equipment.|||microvolts||Standard Deviation|Mean
2553888|NCT02767388|Primary|Change From Baseline Filter Task Performance at 1- and 3- Months|Response accuracy - measured as the proportion of correct trials - is the primary outcome measure of the filter task. Changes in response accuracy were calculated by subtracting response accuracy at 1-month and 3-months from baseline response accuracy. Positive values correspond to an increase in accuracy and negative values correspond to a decline in accuracy.|Collected at Study Induction, 1 month after Study Induction, 3 months after Study Induction|The number analyzed differed between rows due to participant dropout from Month-1 to Month-3. Differences in number analyzed and numbers in the Participant Flow module were due to patient dropout and either: (1) a minority of patients requesting not to complete testing; or (2) difficulties with electrophysiology or stimulus presentation equipment.|||change in proportion of correct trials||Standard Deviation|Mean
2553889|NCT02767388|Primary|Change From Baseline N2pc Amplitude at 1- and 3- Months|Electrophysiological component that measures allocation of attentional resources|Collected at Study Induction, 1 month after Study Induction, 3 months after Study Induction|Differences in number analyzed and numbers in the Participant Flow module were due to patient dropout and either: (1) a minority of patients requesting not to complete testing; or (2) difficulties with electrophysiology or stimulus presentation equipment.|||microvolts||Standard Deviation|Mean
2553890|NCT02767388|Primary|Change From Baseline Capture Task Performance at 1- and 3- Months|Response time - measured as the time required to respond to a target hidden among distractor items - is the primary outcome measure of the capture task. Proportional response time was calculated by subtracting mean response time in the neutral condition from response time in the capture condition, and dividing that number by the standard deviation of response time across conditions. Changes in proportional response time across study visits is reported. Positive values correspond to an increase in response time and negative values correspond to a decrease in response time.|Collected at Study Induction, 1 month after Study Induction, 3 months after Study Induction|The number analyzed differed between rows due to participant dropout from Month-1 to Month-3. Differences in number analyzed and numbers in the Participant Flow module were due to patient dropout and either: (1) a minority of patients requesting not to complete testing; or (2) difficulties with electrophysiology or stimulus presentation equipment.|||change in proportional response time||Standard Deviation|Mean
2553891|NCT02767271|Primary|Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: t1/2 of Luliconazole|Plasma concentration of luliconazole was determined using validated LC/MS method.|Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8|PKC population included all participants with tinea cruris who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||hours||Standard Deviation|Mean
2553892|NCT02767271|Primary|Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: AUC0-24 of Luliconazole|Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method.|Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8|PKC population included all participants with tinea cruris who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment.|||ng*hr/mL||Standard Deviation|Mean
2553893|NCT02767271|Primary|Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Cruris: Cmax of Luliconazole|Plasma concentration of luliconazole was determined using validated LC/MS method.|Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 8|PKC population included all participants with tinea cruris who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment.|||ng/mL||Standard Deviation|Mean
2553894|NCT02767271|Primary|Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Elimination Half-Life (t1/2) of Luliconazole|Plasma concentration of luliconazole was determined using validated LC/MS method.|Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15|PKP population included all participants with tinea pedis who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment. None of the participants in this population was evaluable for this outcome measure at specified timepoint.||||||
2553895|NCT02767271|Primary|Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) of Luliconazole|Plasma concentration of luliconazole was determined using validated LC/MS method. AUC0-24 was calculated by linear trapezoidal method.|Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15|PKP population included all participants with tinea pedis who were enrolled, received at least 1 application of study drug, and had at least 1 PK assessment.|||nanograms*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
2553896|NCT02767271|Primary|Measurement of Circulating Plasma Levels of Luliconazole in Participants Who Had Tinea Pedis: Maximum Observed Plasma Concentration (Cmax) of Luliconazole|Plasma concentration of luliconazole was determined using validated liquid chromatography-mass spectrometry (LC/MS) method.|Pre-dose (15 minutes) and at 1, 3, 6, 9, 12, and 24 hours post-dose on Day 15|PKP population included all participants with tinea pedis who were enrolled, received at least 1 application of study drug, and had at least 1 pharmacokinetic (PK) assessment.|||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
2553897|NCT02767128|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)|The number of participants in each treatment group who experienced treatment emergent serious adverse events will be quantified.|13 days|Safety Population: all enrolled subjects who received at least one dose of study drug.|||Participants|||Count of Participants
2553898|NCT02767128|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|The number of participants in each treatment group who experienced treatment emergent adverse events will be quantified.|13 days|Safety Population: all enrolled subjects who received at least one dose of study drug.|||Participants|||Count of Participants
2553899|NCT02767128|Primary|Pharmacokinetics (PK) of Total Iron From Triferic Administered Orally in Adult Healthy Patients: Cmax|The outcome will be measured by assessing the Cmax of total iron with multiple different oral iron treatment. The following oral iron dosing treatments will be measured: Treatment A (Fer-in-Sol 3 mg iron/kg), Treatment B (Shohl's solution followed after 10 minutes by Fer-In-Sol, 3 mg/kg), Treatment C (Triferic 3 mg iron/kg), Treatment D (Shohl's solution followed after 10 minutes by Triferic 3 mg/kg), Treatment E (Shohl's solution followed immediately by Triferic 3 mg/kg), Treatment F (Triferic 6.6 mg IV over 4 hours)|0, 1, 2, 4, 6, 8, 12, 16, and 24 hours|14 patients completed all six treatments. While all participants had adequate blood samples collected to be included in pharmacokinetic analysis, some samples were below the quantifiable limit (BLQ) of the bioanalytical assay, which was 50 micrograms/deciliter. Therefore, number of participants analyzed for each treatment does not equal 14.|||microgram/deciliter||Geometric Coefficient of Variation|Geometric Mean
2553900|NCT02767011|Secondary|Death|Yes/No Did patient die? Patients for monitored for 30 days for death.|30-day||||Participants|||Count of Participants
2553901|NCT02767011|Secondary|Myocardial Infarction|Yes/No did patient have myocardial infarction. Patients were monitored for 30 days for myocardial infarction.|30-day||||Participants|||Count of Participants
2553902|NCT02767011|Secondary|Stroke|Yes/No did patient have a stroke. Patients were monitored for 30 days for stroke.|30-day||||Participants|||Count of Participants
2553903|NCT02767011|Secondary|Number of Participants With Home Nursing Visits|Yes/No did the patient have (any) home nursing visits during the 30-day follow-up period.|30-day||||Participants|||Count of Participants
2553904|NCT02767011|Secondary|Patient Satisfaction as Measured by the General Satisfaction Sub-scale of the Short-Form Patient Satisfaction Questionnaire (PSQ18)|"Patients' satisfaction was compared using the General Satisfaction sub-scale of the Short-Form Patient Satisfaction Questionnaire (PSQ18). The PSQ-18 contains 18 items (questions) that can measure seven dimensions of satisfaction: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. Responses to the PSQ-18 require a selection on a Likert scale from 1 Strongly Agree to 5 Strongly Disagree with some of the questions worded in such a manner that agreement reflects greater satisfaction (1, 2, 3, 5, 6, 8, 11, 15 & 18). These responses were re-coded in order for a larger number to reflect greater satisfaction. Next, two individual items (3 and 17) are summed and averaged to produce the general satisfaction sub-scale. A larger number reflects greater satisfaction, with a range of 1 to 5."|30-day||||units on a scale||Inter-Quartile Range|Median
2553905|NCT02767011|Secondary|The Difference Between Baseline and 30-day Quality of Life (Short-Form 8) Physical Summary Score|The Difference between baseline and 30-day quality of life (Short-Form 8) Physical summary T-scores. The short-form (SF-8) Health Survey is an 8-item survey designed to measure quality of life. The SF-8 has 8 questions that first measures eight ordinal items (i.e., 1-5 Likert scale): general health, physical health functioning, role physical, bodily pain, vitality, social functioning, mental health and emotional roles. Summing the responses of the 8 items can be used to report an overall measure of physical and mental functioning. The raw Likert scale scores are converted to normalized standard T scores with a mean of 50 and standard deviation of 10. Measuring physical and mental health both before and after an intervention, as continuous summary scores can indicate better self-reported quality of life with higher scores. A difference score of 0 would indicate no change, while a larger positive difference score would indicate an increase in self-reported quality of life.|30-day||||T-scores||Standard Deviation|Mean
2553906|NCT02767011|Primary|Access Site/Wound Infections.|Yes/No did patient any access site or would infections? Access site wounds for the patients were monitored for 30 days for any wound infections.|30-day|Percentage of patients with access site infections.|||Participants|||Count of Participants
2553907|NCT02767011|Primary|30-day Wound Readmission|Yes/No was patient readmitted for wound infection? Patients were monitored for 30 days to see if they were re-admitted to the hospital for wound infection. Percentage of patients with 30-day readmission for wound infection.|30-day||||Participants|||Count of Participants
2553908|NCT02767011|Primary|30-Day Readmission (Any)|Yes/No was patient readmitted? Patients were monitored for 30 days to see if they were re-admitted to the hospital for any reason. Percentage of patients with 30-day readmission.|30-day||||Participants|||Count of Participants
2553909|NCT02766907|Primary|Change in Intraocular Lens Power Calculation|Assessed using biometry and calculated using Holladay I formula|Change from Baseline to 1 month||||D||Standard Deviation|Mean
2553910|NCT02766907|Primary|Change in Intraocular Lens Calculation|Assessed by corneal topography|Change from Baseline to 1 month||||D||Standard Deviation|Mean
2553911|NCT02766673|Secondary|Percent Change in Heart Rate (Beats/Min) Between Pre and Post-medication Dosing|Heart rate will be measured before beginning each treatment and again 15-30 min after the conclusion of each treatment phase (4 hours). Therefore there will be 6 pairs of heart rates (12 measures), to determine the change in HR for each treatment group.|every 4 hours in each treatment group, up to 24 hours|There was a potential for up to 6 paired observations (12 measures) per treatment group. 2 patients did not complete all 3 treatment groups resulting is lower number of observations for the potential total.|||% change|Heart Rate measurements beats/min|Standard Deviation|Mean
2553912|NCT02766673|Primary|Change in Expiratory Flow Between Pre and Post-medication Dosing|Expiratory flow at 75% of vital capacity (EF75) will be measured before beginning each treatment and again 15-30 min after each treatment phase. Therefore there will be 6 pairs (12) of EF values to determine the change in EF for each treatment. this measure is done by measuring the expiratory flow at 75% of exhalation on as measure on the flow volume loop of the ventilator. a single mechanical breath is chosen and the flow volume loop is frozen on the ventilator screen. the clinician can then scroll to measure total tidal volume for the breath, then multiple this volume by 0.25 (to ascertain the volume that the time point of 75% of exhalation), then scroll along the expiratory side of the flow volume loop until the calculated volume is reached and then the flow at that time point is recorded.|every 4 hours in each treatment group, up to 24 hours|Each subject had the potential for 6 paired observations (12 measures) per treatment group (comparison of measure before and after each dose of the study drug). 2 subjects did not complete all 3 treatment groups. Some measurements were missed leaving less than the total potential number of observations.|||L/min|EF 75% Observatrions|Standard Deviation|Mean
2553913|NCT02766608|Other Pre-specified|Substudy: 12-hour PFT Endpoint FEV1 AUC0-12|Substudy: 12-hour PFT (Pulmonary Function Test) endpoint FEV1 (Forced Expiratory Volume) AUC0-12 (Area under the Curve 0-12). Changes from baseline in FEV1 AUC0-12 were normalized by taking the area under the curve value and dividing by the length of time under consideration. This normalization represents a weighted average of the change from baseline in FEV1 over the 12-hour period.|at Week 12|mITT|||Liter||95% Confidence Interval|Least Squares Mean
2553914|NCT02766608|Secondary|FEV1 on Day 1, 4 Hours, Time to Onset of Action Determination|Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.|Day 1 - 4 Hours|mITT|||Liter||95% Confidence Interval|Least Squares Mean
2553915|NCT02766608|Secondary|FEV1 on Day 1, 2 Hours, Time to Onset of Action Determination|Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.|Day 1 - 2 Hours|mITT|||Liter||95% Confidence Interval|Least Squares Mean
2553916|NCT02766608|Secondary|FEV1 on Day 1, 1 Hour, Time to Onset of Action Determination|Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.|Day 1 - 1 Hour|mITT|||Liter||95% Confidence Interval|Least Squares Mean
2553917|NCT02766608|Secondary|FEV1 on Day 1, 30 Minutes, Time to Onset of Action Determination|Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.|Day 1 - 30 Minutes|mITT|||Liter||95% Confidence Interval|Least Squares Mean
2553918|NCT02766608|Secondary|FEV1 on Day 1, 15 Minutes, Time to Onset of Action Determination|Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.|Day 1 - 15 Minutes|mITT|||Liter||95% Confidence Interval|Least Squares Mean
2553919|NCT02766608|Secondary|FEV1 on Day 1, 5 Minutes, Time to Onset of Action Determination|Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.|Day 1 - 5 Minutes|mITT|||Liter||95% Confidence Interval|Least Squares Mean
2553920|NCT02766608|Secondary|Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks (BFF MDI vs BD MDI)|Change from baseline in average daily rescue Ventolin HFA use over 24 weeks (BFF MDI vs BD MDI)|over 24 Weeks|mITT|||Puffs per day||95% Confidence Interval|Least Squares Mean
2553921|NCT02766608|Secondary|Peak Change From Baseline in FEV1 at Week 24 (BFF MDI vs BD MDI)|Peak change from baseline in FEV1 (Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)|at Week 24|mITT|||Liter||95% Confidence Interval|Least Squares Mean
2553922|NCT02766608|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI vs BD MDI)|Change from baseline in morning pre-dose trough FEV1(Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)|at Week 24|mITT|||Liter||95% Confidence Interval|Least Squares Mean
2553923|NCT02766608|Secondary|Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in SGRQ at Week 24|The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI, FF MDI, BD MDI, & Symbicort TBH on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.|at Week 24|mITT|||Percentage of Subjects|||Number
2553924|NCT02766608|Secondary|Time to First Moderate or Severe COPD Exacerbation (BFF MDI vs FF MDI).|Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation (BFF MDI vs FF MDI).|over 24 Weeks (timepoints of 4, 12 & 20 weeks)|mITT|||Percentage of Participants||95% Confidence Interval|Number
2553925|NCT02766608|Primary|Change From Baseline in FEV1 AUC0-4 (BFF MDI vs BD MDI)|Changes from baseline in FEV1 AUC0-4 were normalized by taking the area under the curve value and dividing by the length of time under consideration (usually 4 hours). This normalization represents a weighted average of the change from baseline in FEV1 over the 4-hour period.|at Week 24|mITT|||Liter||95% Confidence Interval|Least Squares Mean
2553927|NCT02766517|Primary|Plasma Calcitonin Gene-Related Peptide (CGRP) Levels|The mean Plasma Calcitonin Gene-Related Peptide levels were reported.|On assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993|All enrolled participants who have evaluable pharmacodynamics data.|||picogram per milliliter (pg/mL)||Standard Deviation|Mean
2553928|NCT02766517|Primary|The Capsaicin-Induced Dermal Blood Flow (DBF)|Change from pre-capsaicin DBF adjusting for vehicle at 30 minutes is reported. The capsaicin induced dermal blood flow (DBF) was measured by laser Doppler imaging (LDI).|Baseline (pre-capsaicin) and on assessment day over approximately one hour, after at least a 4 month wash out from treatment in study NCT02163993|All enrolled participants who have evaluable pharmacodynamics data.|||Flux mean||Standard Deviation|Mean
2553929|NCT02766400|Primary|Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time|"Differences between groups in mean independence scores (computed from Functional Independence Measure total scores) over time.~The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated for each participant at baseline, discharge, month 3, month 6, and month 12, and mean total scores for each group were calculated at each time point. Differences in mean scores were examined between groups over time with mixed model analyses."|Baseline, rehab discharge, month 3, month 6, month 12||||units on a scale||Standard Error|Mean
2553930|NCT02766374|Primary|Magnitude Change of Airway Reactivity Measured by Methacholine PC20FEV1|Change in PEC20FEV1 measured after biofeedback from the PC20FEV1 measured at baseline|4-weeks||||mg/ml||95% Confidence Interval|Mean
2553931|NCT02766283|Secondary|"The Duration of Hypothyroidism Episode in the Probable Iodine Induced Category"|Based on the information collected from the database, the probable shortest duration of Hypothyroidism was ascertained for the cases below.|Up to one year after ICM exposure (828 person years)|Probable iodine-induced hypothyroidism: (N=8) included all potential cases of hypothyroidism with no other cause than the previous ICM exposure could be identified.|||Days|||Number
2553932|NCT02766283|Secondary|"The Duration of Hypothyroidism Episode in the Probable Iodine Induced Category"|Based on the information collected from the database, the probable shortest duration of Hypothyroidism was ascertained for the cases below.|Up to one year after ICM exposure (828 person years)|Probable iodine-induced hypothyroidism: (N=8) included all potential cases of hypothyroidism with no other cause than the previous ICM exposure could be identified.|||Months|||Number
2553933|NCT02766283|Secondary|"The Duration of Hypothyroidism Episode in the Probable Iodine Induced Category"|Based on the information collected from the database, the probable longest duration of Hypothyroidism was ascertained for the cases below.|Up to one year after ICM exposure (828 person years)|Probable iodine-induced hypothyroidism: (N=8) included all potential cases of hypothyroidism with no other cause than the previous ICM exposure could be identified.|||Months|||Number
2553934|NCT02766283|Secondary|Time-relation Between Iodine Contrast Exposure and Diagnosis of Hypothyroidism||Up to one year after ICM exposure (828 person years)|Final Cohort|||Days||Standard Deviation|Mean
2553935|NCT02766283|Secondary|Baseline Characteristics (Time Between Examinations) in Cases With an Indication of Hypothyroidism and Cases Without||Up to one year after ICM exposure (828 person years)|Final Cohort|||Days||Standard Deviation|Mean
2553936|NCT02766283|Secondary|Baseline Characteristics (Type of 2nd Examination) in Cases With an Indication of Hypothyroidism and Cases Without||Up to one year after ICM exposure (828 person years)|Final Cohort|||Participants|||Count of Participants
2553937|NCT02766283|Secondary|Baseline Characteristics (Type of 1st Examination) in Cases With an Indication of Hypothyroidism and Cases Without||Up to one year after ICM exposure (828 person years)|Final Cohort|||Participants|||Count of Participants
2553938|NCT02766283|Secondary|Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without||Up to one year after ICM exposure (828 person years)|Final Cohort|||Participants|||Count of Participants
2553939|NCT02766283|Secondary|Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort||Prior to first examination|Final Cohort|||Participants|||Count of Participants
2553940|NCT02766283|Secondary|Baseline Characteristics (Weight) of the Cases With Hypothyroidism and of the Rest of the Cohort||Within a range of ±360 days of the first examination|Final Cohort|||Kilograms||Standard Deviation|Mean
2553941|NCT02766283|Secondary|Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort||At first examination|Final Cohort|||Years||Standard Deviation|Mean
2553942|NCT02766283|Secondary|Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort||Up to one year after ICM exposure (828 person years)|Final Cohort|||Participants|||Count of Participants
2553943|NCT02766283|Primary|Number of Pediatric Patients With Detected Hypothyroidism After Iodinated Contrast Exposure in a Routine Clinical Practice Setting||Up to one year after iodinated contrast material (ICM) exposure (828 person years)|Final Cohort|||Participants|||Count of Participants
2553944|NCT02766244|Primary|Perfusion of Burned Area|Perfusion as measured by ICG Fluorescence|5 days||||% perfusion compared to normal skin|||Number
2553945|NCT02766088|Secondary|Number of Subjects With Serious Adverse Events (SAEs) Related to a Study Procedure|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject..|From Day 0 to Month 24 (study end)|Analysis was performed on the Total cohort that included all subjects enrolled in the study.|||Participants|||Count of Participants
2553970|NCT02766023|Secondary|Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction as Influence|Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including if their current partner's reaction to the product influenced their use of the product.|Day 84|The analysis population includes all treated participants who completed the questionnaire and had a current partner.|||Participants|||Count of Participants
2553946|NCT02766088|Secondary|Number of Suspected Dengue Cases With Severity Criteria Characteristics|The clinical classification of the suspected dengue cases were distributed among following categories: Subject hospitalized during suspected dengue episode; OR At least 1 WHO 2009 warning signs: i.e. Abdominal pain or tenderness, Persistent vomiting, Clinical fluid accumulation, Mucosal bleed, Liver enlargement, Increase in HCT concurrent with rapid decrease in platelet count, Lethargy and restlessness; OR At least 1 WHO 2009 criteria for severe dengue: i.e. Severe Plasma Leakage leading to Shock, Fluid accumulation with respiratory distress, Severe Bleeding, Severe organ involvement; Liver: Aspartate transaminase or Alanine transferase ≥ 1000 International Unit/Liter, Central nervous system: impaired consciousness, Failure of heart and other organs; OR Most likely diagnosis for an episode of defined illnesses [investigator opinion]. The following characteristics were summarized for Virologically confirmed cases (VDC) and other SDC (oSDC), no probable cases being reported.|From Day 0 to Month 24 (study end)|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol, for whom data of at least one follow-up contact were available and who were defined as suspected dengue cases.|||Participants|||Count of Participants
2553947|NCT02766088|Secondary|Number of Suspected Dengue Cases With Temperature and Any Symptom From First and Returned Visits|The following characteristics were summarized for each category of dengue cases (Virologically confirmed, probable, other SDC): Temperature at first visit: <37.5, ≥37.5, >38, >38.5, >39 °C and Clinical symptoms at onset, from first and returned visits. The results are presented for the virologically confirmed cases (VDC) and the other SDC (oSDC), no probable cases being reported in the study.|From Day 0 to Month 24 (study end)|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol, for whom data of at least one follow-up contact were available and who were defined as suspected dengue cases.|||Participants|||Count of Participants
2553948|NCT02766088|Secondary|Percentage of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category.|"The percentage of subjects with Dengue Virus antibody IgG positive result (ELISA) was expressed as percentage of subjects = (n [number of subjects with at least one event reported during the study period]/N [number of subjects in the population]) X 100. The 95% Wald CI was calculated. Clustering effect was not retained because equal or less than 1. Ages categories were defined as follows: 6 months -<12 Months = from the 6 Months birthday up to and including the day before the 1st year birthday, and the next n-p Years categories = from the nth Year birthday up to and including the day before the (p+1)th Year birthday. Analysis was not summarized for confirmed and probable dengue cases, separately as there were no probable cases reported in the study."|At Day 0|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects from Mexico (1-4 years age) and the Philippines (6-12 months), i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol and for whom data of at least one follow-up contact were available.|||Percentage of subjects||95% Confidence Interval|Number
2553949|NCT02766088|Secondary|Proportion of Subjects With Dengue Virus Antibody IgG Positive Result (ELISA) at First Visit (Indicative of Past DENV Infection), by Study Site and Age Category.|"The proportion of subjects with Dengue Virus antibody IgG positive result (ELISA) was estimated from GEE model with clustering effect. The 95% CI was based on the robust variance estimate from the GEE model. Clusters were households for analysis by study site. Ages categories were defined as follows: 6 months -<12 Months = from the 6 Months birthday up to and including the day before the 1st year birthday, and the next n-p Years categories = from the nth Year birthday up to and including the day before the (p+1)th Year birthday. Analysis was not summarized for confirmed and probable dengue cases, separately, as there were no probable cases reported in the study."|At Day 0|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol and for whom data of at least one follow-up contact were available.|||Proportion of subjects||95% Confidence Interval|Number
2553950|NCT02766088|Secondary|Incidence Proportion of Probable Symptomatic Dengue Infection During the Study Period.|Incidence proportion of probable confirmed symptomatic dengue infection was estimated from GEE model with clustering effect. Clusters were households for analysis by study site and study sites for analysis on overall study sites. A probable confirmed dengue infection is an SDC with DENV RT-qPCR negative or not performed (late presenter), and DENV NS1 negative or undetermined (early or late presenter), and Anti-DENV Immunoglobulin type M (IgM) positive with a rapid immunochromatographic (ICT) assay or an Enzyme-linked Immunosorbent Assay (ELISA) assay, or Anti-DENV IgG positive (rapid ICT assay or 'capture ELISA' assay). SDC defined as acute febrile illness measured as greater or equal to 38.0°C or recent history of febrile illness (onset in the past 8 days) reported for at least 2 consecutive days (duration of approximately 36-48 hours) and < 7 days duration, which might be accompanied by other dengue symptoms or signs with no defined focus or obvious reason unrelated to dengue.|From Day 0 to Month 24 (study end)|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol and for whom data of at least one follow-up contact were available.|||Proportion of subjects||95% Confidence Interval|Number
2553951|NCT02766088|Secondary|Incidence Percentage of Virologically Confirmed Symptomatic Dengue Infection During the Study Period in the Philippines.|Incidence percentage of virologically confirmed symptomatic dengue infection was expressed as percentage of subjects = (n [number of subjects with at least one event reported during the study period]/N [number of subjects in the population]) X 100. The 95% Wald CI was calculated. Clustering effect was not retained because equal or less than 1. RT-qPCR confirmed symptomatic case = suspected dengue case (SDC) confirmed by RT-qPCR. See SDC definition in outcome 5.|From Day 0 to Month 24 (study end)|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects from the Philippines, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol and for whom data of at least one follow-up contact were available.|||Percentage of subjects||95% Confidence Interval|Number
2553985|NCT02765269|Secondary|Pain Management|"Numerical rating scale allows a person to describe the intensity of his/her pain as a number usually ranging from 0 to 10, where 0 means no pain and 10 means pain as bad as it could be. Higher values means worse outcomes. The investigators will compare average pain score assessed by numerical rating scale at the end of the trial period."|2 weeks||||scores on a scale||Standard Deviation|Mean
2553952|NCT02766088|Secondary|Incidence Proportion of Virologically Confirmed Symptomatic Dengue Infection During the Study Period in Mexico|Incidence proportion of virologically confirmed symptomatic dengue infection was estimated from GEE logistic regression model taking the clustering effect into account. The 95% confidence interval was based on the robust variance estimate from the GEE model. Clusters were households for analysis by study site. Virologically confirmed symptomatic case = suspected dengue case (SDC) confirmed by RT-qPCR or non-structural protein 1 (NS1). See SDC definition in outcome 5.|From Day 0 to Month 24 (study end)|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol and for whom data of at least one follow-up contact were available.|||Proportion of subjects||95% Confidence Interval|Number
2553953|NCT02766088|Secondary|Number of Subjects With DENV-type Specific Confirmed Symptomatic DENV Infection|Dengue Virus (DENV)-Type 1, 2 3 or 4 Ribonucleid acid would have been considered for this analysis but it was not performed due to the low number of cases reported.|From Day 0 to Month 24 (study end)|No data was collected by DENV-type due to the low number of cases reported, therefore no analysis could be performed.||||||
2553954|NCT02766088|Primary|Incidence Percentage of Reverse Transcriptase Quantitative Polymerase Chain Reaction (RT-qPCR) Confirmed Symptomatic Dengue Infection During the Study Period by Study Site|Incidence percentage of RT-qPCR confirmed symptomatic dengue infection was expressed as percentage of subjects = (n [number of subjects with at least one event reported during the study period ]/N [number of subjects in the population]) X 100. The 95% Wald CI was calculated. Clustering effect was not retained because equal or less than 1. RT-qPCR confirmed symptomatic case = suspected dengue case (SDC) confirmed by RT-qPCR. See SDC definition in outcome 5.|From Day 0 to Month 24 (study end)|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects, i.e. subjects who met all eligibility criteria, complying with the procedures defined in the protocol and for whom data of at least one follow-up contact were available.|||Percentage of subjects||95% Confidence Interval|Number
2553955|NCT02766023|Secondary|The Number of Participants Who Discontinued Study Product Early in Each Study Arm Due to Adverse Events.|Tolerability of LACTIN-V and the applicator was measured by the proportion of participants who discontinued the study product prior to completing the dose schedule due to an adverse event.|Day 1 to Day 84|The analysis population included all treated participants. One participant randomized to LACTIN-V was not treated.|||Participants|||Count of Participants
2553956|NCT02766023|Secondary|The Proportion of Participants With a Positive BV Diagnosis in Each Study Arm.|A positive BV diagnosis was defined by at least 3 of the 4 Amsel criteria and a Nugent score of 4-10. Amsel criteria are: homogeneous, thin, grayish-white discharge that smoothly coats the vaginal walls; vaginal pH >4.5; positive whiff-amine test, defined as the presence of a fishy odor when a drop of 10% potassium hydroxide is added to a sample of vaginal discharge; and presence of clue cells (>20%) on microscopy. The Nugent score is calculated by assessing for the presence of large Gram-positive rods scored as 0 to 4, small Gram-variable rods scored as 0 to 4, and curved Gram-variable rods scored as 0 to 2. All BV diagnoses following 15 days after enrollment (22 days after commencement of MetroGel treatment) were considered a recurrent episode.|Day 1 to Day 168|The analysis population was the intent-to-treat population (all randomized participants).|||percentage of participants||95% Confidence Interval|Number
2553957|NCT02766023|Secondary|The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product Overall.|Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL|Day 1 to Day 168|The analysis population was the intent-to-treat population (all randomized participants).|||percentage of participants||95% Confidence Interval|Number
2553958|NCT02766023|Secondary|The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses.|Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL|Day 84|The analysis population includes participants with results at the visit.|||Participants|||Count of Participants
2553959|NCT02766023|Secondary|The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses.|Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL|Day 56|The analysis population includes participants with results at the visit.|||Participants|||Count of Participants
2553960|NCT02766023|Secondary|The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Menses.|Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL|Day 28|The analysis population includes participants with results at the visit.|||Participants|||Count of Participants
2553986|NCT02765269|Primary|Feasibility of Mobile Application Assessed by Observing the Number of Daily Pain Assessments Recorded Among Patients|The primary objective is to demonstrate that this mobile application is feasible by observing the numbers of daily pain assessment among patients.|2 weeks||||pain assessments per day||Standard Deviation|Mean
2553961|NCT02766023|Secondary|The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse.|Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL|Day 84|The analysis population includes participants with results at the visit.|||Participants|||Count of Participants
2553962|NCT02766023|Secondary|The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse.|Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL|Day 56|The analysis population includes participants with results at the visit.|||Participants|||Count of Participants
2553963|NCT02766023|Secondary|The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse.|Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL|Day 28|The analysis population includes participants with results at the visit.|||Participants|||Count of Participants
2553964|NCT02766023|Secondary|The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product by Occurrence of Intercourse.|Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL|Day 1|The analysis population includes participants with results at the visit.|||Participants|||Count of Participants
2553965|NCT02766023|Secondary|The Proportion of Participants Experiencing Successful Colonization With L. Crispatus CTV-05 Following Dose of Study Product in the LACTIN-V Arm Overall.|Colonization of L. crispatus was determined from the concentrations of L. crispatus species and L. crispatus CTV-05 obtained from qPCR. Successful colonization was defined as: If CTV-05 concentration was above the lower limit of detection (LLOD) and the L. crispatus was above the LLOD, then successful colonization had occurred. If either CTV-05 or L. crispatus concentration was below LLOD or indeterminate, then successful colonization had not occurred. The LLOD for CTV-05 was 660 copies/mL and the LLOD for L. crispatus was 953 copies/mL|Day 1 to Day 84|The analysis population is intent to treat.|||percentage of participants||95% Confidence Interval|Number
2553966|NCT02766023|Secondary|Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product Use|"Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including by rating factors on use of the product on a 0-10 scale, with 0 being not at all and 10 being extremely so."|Day 84|The analysis population includes all treated participants who completed the questionnaire.|||units on a scale||Standard Deviation|Mean
2553967|NCT02766023|Secondary|Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Continuous/Discrete Response Regarding Product|"Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including by rating factors on a 0-10 scale, with 0 being not at all and 10 being extremely."|Day 84|The analysis population includes all treated participants who completed the questionnaire.|||units on a scale||Standard Deviation|Mean
2553968|NCT02766023|Secondary|Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience of Side Effects Make Less Likely to Use|"Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including a Yes/No question about experiencing side effects. For those participants who answered Yes to experiencing side effects, a follow-up question asked would these side effects make you less likely to use the product again?"|Day 84|"The analysis population is limited to those participants who answered Yes to the question Did you experience any side effects using the product?"|||Participants|||Count of Participants
2553969|NCT02766023|Secondary|Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Experience Side Effects|Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including a Yes/No question about experiencing side effects.|Day 84|The analysis population includes all treated participants who completed the questionnaire.|||Participants|||Count of Participants
2553982|NCT02765490|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)|The SVR 12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 12 weeks after actual EOT.|Week 12 (Follow-Up Phase)|Intent-To-Treat (ITT) population included all randomized participants who took at least 1 dose of the study drug [that is AL-335, Odalasvir (ODV) or Simeprevir (SMV)].|||Percentage of Participants||95% Confidence Interval|Number
2553971|NCT02766023|Secondary|Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Current Partner's Reaction to the Product|"Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including My current partner's reaction to the product was... with the options as listed below."|Day 84|The analysis population includes all treated participants who completed the questionnaire.|||Participants|||Count of Participants
2553972|NCT02766023|Secondary|Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Likelihood to Use|"Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by various measures, including the question, If a non-antibiotic, clinically proven lactobacillus product were available for treatment and prevention of BV, what are the chances that you would use it?"|Day 84|The analysis population includes all treated participants who completed the questionnaire.|||Participants|||Count of Participants
2553973|NCT02766023|Secondary|Acceptability of LACTIN-V and the Applicator Measured by Self-administered Questionnaires About Acceptability - Categorical Variables on Likert Scale|Participants answered a detailed self-administered questionnaire at Week 12 assessing the acceptability of the study product and the applicator. Questionnaire items included rating aspects of the product and applicator by Likert-scale responses of strongly agree, agree, neutral, disagree and strongly disagree.|Day 84|The analysis population includes all treated participants who completed the questionnaire.|||Participants|||Count of Participants
2553974|NCT02766023|Secondary|The Proportion of Participants Who Are Compliant With the Complete Dose Regimen as Assessed by Participant Reporting and Applicator Staining.|A subject was considered compliant with the assigned study product if she took 4 of the first 5 daily doses and at least 75% of the scheduled doses overall prior to the first diagnosis of BV or through Week 12, whichever occurred first. Compliance was assessed by subject report via the memory aid and, separately, applicator staining of the returned kit. Compliance was assessed on a weekly basis and the time (week) at which the subject became non-compliant was determined by blinded PI review.|Day 1 to Day 84|The analysis population was the intent-to-treat population (all randomized participants).|||proportion of participants||95% Confidence Interval|Number
2553975|NCT02766023|Primary|The Proportion of Participants With a Positive BV Diagnosis in Each Study Arm.|A positive BV diagnosis was defined by meeting at least 3 of the 4 Amsel criteria and a Nugent score of 4-10. Amsel criteria are: homogeneous, thin, grayish-white discharge that smoothly coats the vaginal walls; vaginal pH >4.5; positive whiff-amine test, defined as the presence of a fishy odor when a drop of 10% potassium hydroxide is added to a sample of vaginal discharge; and presence of clue cells (>20%) on microscopy. The Amsel score ranges from 0-4, where higher scores mean a worse outcome. The Nugent score is calculated by assessing for the presence of large Gram-positive rods scored as 0 to 4, small Gram-variable rods scored as 0 to 4, and curved Gram-variable rods scored as 0 to 2, and adding all component scores. The Nugent score ranges from 0-10, where higher scores mean a worse outcome. All BV diagnoses following 15 days after enrollment (22 days after commencement of MetroGel treatment) were considered a recurrent episode.|Day 1 to Day 84|The analysis population was the intent-to-treat population (all randomized participants). Missing BV recurrence data was imputed using Last Observation Carried Forward|||proportion of participants||95% Confidence Interval|Number
2553976|NCT02766023|Primary|The Proportion of Participants Reporting Product-related Adverse Events (AEs) and Serious Adverse Events (SAEs) in Each Study Arm.|"Adverse events and serious adverse events were collected during the entire study period. Relatedness to study product was assessed by the site investigator according to the protocol definition of related as There is a reasonable possibility that the study product caused the AE. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the AE."|Day 1 to Day 168|The safety population included all participants receiving study product. One participant randomized to LACTIN-V was not treated.|||proportion of participants||95% Confidence Interval|Number
2553977|NCT02765490|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Treatment (EOT)|The SVR 4 was defined as participants were considered to have reached SVR4, if 4 weeks after the actual EOT, HCV RNA was <LLOQ (detectable or undetectable).|Week 4 (Follow-Up Phase)|ITT population included all randomized participants who took at least 1 dose of the study drug (i.e, AL-335, ODV or SMV).|||Percentage of Participants||95% Confidence Interval|Number
2553978|NCT02765490|Secondary|Percentage of Participants With On-treatment Failure|On-treatment failure: Participants who did not achieve SVR12 and with confirmed HCV RNA>=LLOQ at the End of Treatment (EOT).|EOT up to Week 12 (Follow up Phase)|ITT population included all randomized participants who took at least 1 dose of the study drug (i.e, AL-335, ODV or SMV).|||Percentage of Participants|||Number
2553979|NCT02765490|Secondary|Number of Participants With Late Viral Relapse|Late Viral Relapse: Participants who achieved SVR12 but had confirmed HCV RNA>=LLOQ afterwards during follow-up.|Up to Week 24 (Follow-up Phase)|ITT population included all randomized participants who took at least 1 dose of the study drug (i.e, AL-335, ODV or SMV).|||Participants|||Number
2553980|NCT02765490|Secondary|Number of Participants With Viral Relapse|Viral Relapse: Participants who did not achieve SVR12, with HCV RNA <LLOQ at the EOT and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up.|End of Treatment up to Week 24 (Follow up phase)|ITT population included all randomized participants who took at least 1 dose of the study drug (i.e, AL-335, ODV or SMV).|||Participants|||Number
2553981|NCT02765490|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Treatment (SVR24)|The SVR24 was defined as HCV RNA <LLOQ (detectable or undetectable) 24 weeks after End of Treatment (EOT).|Week 24 (Follow-Up Phase)|ITT population included all randomized participants who took at least 1 dose of the study drug (i.e., AL-335, ODV or SMV). Last Observation Carried Forward (LOCF) method was used to impute the missing values.|||Percentage of Participants||95% Confidence Interval|Number
2553983|NCT02765269|Secondary|Karnofsky Performance Score Evaluation|"The Karnofsky performance score runs from 100 to 0, where 100 is perfect health and 0 is death. Higher values represent better outcomes.The investigators will compare average score between trial group and control group."|2 weeks||||scores on a scale||Standard Deviation|Mean
2553992|NCT02764697|Primary|Number of Participants With Clinically Significant Improvement of Macular Edema|Clinically Significant Uveitic Macular Edema: Clinical Improvement of Macular Edema with OCT Documentation of central foveal thickness < 300 microns|12 weeks|0|||Participants|||Count of Participants
2553993|NCT02764697|Primary|Number of Participants With Photographic Haze Reduced to Grade 0 or Down 2 Steps Documented With Fundus Photography|Subjects will have fundus photography at baseline and 12 weeks. Intermediate uveitis is graded by haze; it is done using the photographic scale: grades 0-4 (lower values are a better outcome), utilized by the SUN criteria, based on the Nussenblatt photographic vitreous haze scale|12 Weeks||||Participants|||Count of Participants
2553994|NCT02764229|Primary|Number of Subjects With Types of Adverse Events (AEs), Serious Adverse Events and AEs That Led to Discontinuation of Treatment|Adverse events (AEs) were collected from the time a subject signed the informed consent and completed participation in the preceding double-blind trial LYC-30937-2001. Treatment-emergent adverse events (TEAEs) are AEs occurring or worsening after the first dose of study drug (LYC-30937-EC 25 mg). Adverse event severity was assessed by the Investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.03, with grading as follows: Grade 1 = mild (asymptomatic or mild symptoms), Grade 2 = moderate (minimal, local intervention, or noninvasive intervention indicated); Grade 3 = severe (or medically significant but not life-threatening); Grade 4 = life-threatening; Grade 5 = death.|46 weeks|Safety Set, consisting of all subjects who took at least 1 dose of study drug. 112 subjects signed consent to participate in the study and 111 of these were confirmed to have taken at least 1 dose of study drug. (One subject was lost to follow-up after enrolling and it was not confirmed that they took study drug.)|||Participants|||Count of Participants
2553995|NCT02764190|Secondary|Tobacco Use|Adolescent self-reported tobacco use in past 3 months|12 month|||||||
2553996|NCT02764190|Secondary|Tobacco Use|Adolescent self-reported tobacco use in past 3 months|6 month|||||||
2553997|NCT02764190|Secondary|Readiness to Change Ruler Questionnaire|Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.|12 month|||||||
2553998|NCT02764190|Secondary|Readiness to Change Ruler Questionnaire|Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.|6 month|||||||
2553999|NCT02764190|Secondary|Readiness to Change Ruler Questionnaire|Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.|3 month|||||||
2554000|NCT02764190|Secondary|Readiness to Change Ruler Questionnaire|Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.|1 day|||||||
2554001|NCT02764190|Secondary|Interval Receipt of Care Questionnaire|Dichotomous variable indicating receipt of any follow-up care to address risk|12 month|||||||
2554002|NCT02764190|Secondary|Interval Receipt of Care Questionnaire|Dichotomous variable indicating receipt of any follow-up care to address risk|6 month|||||||
2554003|NCT02764190|Secondary|Interval Receipt of Care Questionnaire|Dichotomous variable indicating receipt of any follow-up care to address risk behaviors identified at baseline adjusted for baseline number of health risk behaviors.|3 month|||||||
2554004|NCT02764190|Secondary|Driving With Alcohol Impairment|Adolescent self-reported driving under the influence of a substance|12 month|||||||
2554005|NCT02764190|Secondary|Driving With Alcohol Impairment|Adolescent self-reported driving under the influence of a substance|6 month|||||||
2554006|NCT02764190|Secondary|Condom Use and/or Birth Control Use|Adolescent self-reported condom use with sexual intercourse in the past 3 months and/or use of birth control at last sexual intercourse|12 month|||||||
2554007|NCT02764190|Secondary|Condom Use and/or Birth Control Use|Adolescent self-reported condom use with sexual intercourse in the past 3 months and/or use of birth control at last sexual intercourse|6 month|||||||
2554008|NCT02764190|Secondary|Texting While Driving|Adolescent self-reported endorsement of texting while driving in past 3 months|12 month|||||||
2554009|NCT02764190|Secondary|Texting While Driving|Adolescent self-reported endorsement of texting while driving in past 3 months|6 month|||||||
2554010|NCT02764190|Secondary|Helmet Use|Adolescent self-reported frequency of helmet use while bicycling in past 3 months|12 month|||||||
2554011|NCT02764190|Secondary|Helmet Use|Adolescent self-reported frequency of helmet use while bicycling in past 3 months|6 month|||||||
2554012|NCT02764190|Secondary|Seatbelt Use|Adolescent self-reported frequency of seatbelt use in a car in past 3 months|12 month|||||||
2554013|NCT02764190|Secondary|Seatbelt Use|Adolescent self-reported frequency of seatbelt use in a car in past 3 months|6 month|||||||
2554014|NCT02764190|Secondary|Depression|Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks|12 month|||||||
2554015|NCT02764190|Secondary|Depression|Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire in past 2 weeks|6 month|||||||
2554016|NCT02764190|Secondary|Marijuana and/or Other Consumption|Adolescent self-reported number of days using marijuana in the past month and/or other drugs used in past 3 months|12 month|||||||
2554017|NCT02764190|Secondary|Marijuana and/or Other Drug Consumption|Adolescent self-reported number of days using marijuana in the past month and/or other drugs used in past 3 months|6 month|||||||
2554018|NCT02764190|Secondary|Alcohol Consumption|Adolescent self-reported number of days of alcohol consumption and drinks during typical drinking episode in the prior month|12 month|||||||
2554019|NCT02764190|Secondary|Alcohol Consumption|Adolescent self-reported number of days of alcohol consumption and drinks during typical drinking episode in the prior month|6 month|||||||
2554020|NCT02764190|Secondary|Sleep|Adolescent self-reported hours of sleep on a typical night in past 3 months|12 month|||||||
2554021|NCT02764190|Secondary|Sleep|Adolescent self-reported hours of sleep on a typical night in past 3 months|6 month|||||||
2554022|NCT02764190|Secondary|Physical Activity|Adolescent self-reported days with >60 minutes of physical activity in an average week in past 3 months|12 month|||||||
2554023|NCT02764190|Secondary|Physical Activity|Adolescent self-reported days with >60 minutes of physical activity in an average week in past 3 months|6 month|||||||
2554028|NCT02764190|Secondary|Number of Health Risk Behaviors|"Adolescent total count health-risk behaviors at 12 month follow-up including: During typical day: ≥2 sugar-sweetened beverages consumed and ≤3 servings fruits/vegetables consumed; ≤3 days with 60+ minutes exercise during typical week; having texted while driving in past 3 months; ≤7 hours of sleep during typical night; not always using seatbelt; not always using helmet when bicycling; having driven under the influence of substances; tobacco use; days of alcohol consumption in last 30 days (risk based on age: ≥1 day/30 days (ages 13-15), ≥2 days/30 days (ages 16-17), or ≥3 days/30 days (age 18))and/or number of drinks per drinking episode (risk based on age and sex: ≥3 (Girls 13-17; Boys 13), ≥4 (Girls 18; Boys 14-15), or ≥5 (Boys 16-18)); days marijuana consumption in 30 day (risk based on age) and/or other drugs use in past 3 months; not using birth control during last sexual intercourse and/or not always using a condom; and score of ≥10 on PHQ-9."|12 month|||||||
2554029|NCT02764190|Secondary|Number of Health Risk Behaviors|"Adolescent total count health-risk behaviors at 6 month follow-up including: During typical day: ≥2 sugar-sweetened beverages consumed and ≤3 servings fruits/vegetables consumed; ≤3 days with 60+ minutes exercise during typical week; having texted while driving in past 3 months; ≤7 hours of sleep during typical night; not always using seatbelt; not always using helmet when bicycling; having driven under the influence of substances; tobacco use; days of alcohol consumption in last 30 days (risk based on age: ≥1 day/30 days (ages 13-15), ≥2 days/30 days (ages 16-17), or ≥3 days/30 days (age 18))and/or number of drinks per drinking episode (risk based on age and sex: ≥3 (Girls 13-17; Boys 13), ≥4 (Girls 18; Boys 14-15), or ≥5 (Boys 16-18)); days marijuana consumption in 30 day (risk based on age) and/or other drugs use in past 3 months; not using birth control during last sexual intercourse and/or not always using a condom; and score of ≥10 on PHQ-9."|6 month|||||||
2554030|NCT02764190|Secondary|Percent of Risk Behaviors Counseled on During Primary Care Appointment|Percent of adolescent-reported health risk behaviors discussed with the healthcare provider during the primary care visit adjusted for the total number of health risk behaviors reported at baseline.|1 day||||percentage of risk behaviors counselled|||Number
2554031|NCT02764190|Primary|Tobacco Use|Adolescent self-reported tobacco use in the past 3 months. The tobacco use scale includes 2 values: 0=no (min) or 1=yes (max). Higher scores mean a worse outcome.|3 months||||score on a scale||Standard Deviation|Mean
2554032|NCT02764190|Primary|Adolescent Perception of Patient-Centeredness|The total score on the Consultation and Relational Empathy measure (CARE) is used to assess adolescent self-report of perceived patient-centeredness from their primary care provider. Scores on the scale range from 10 (min) to 50 (max) with higher scores indicating a better outcome.|1 day||||score on a scale||Standard Deviation|Mean
2554033|NCT02764190|Primary|Caregiver Satisfaction With Care|Caregiver satisfaction with care is assessed using the four items adapted from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) measure at 1-day follow-up. Scores on this scale range from 3 (min) to 22 (max) with higher scores indicating higher satisfaction with care.|1-day||||score on a scale||Standard Deviation|Mean
2554034|NCT02764190|Primary|Adolescent Satisfaction With Care|Adolescent satisfaction with care is assessed using one item adapted from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) measure at 1-day follow-up. The CAHPS scale includes 10 values: 1 (min) to 10 (max). Higher scores mean a better outcome.|1-day||||score on a scale||Standard Deviation|Mean
2554035|NCT02764190|Primary|Driving With Impairment|Adolescent self-reported driving under the influence of a substance in the past 3 months. This question was asked only of adolescents who drive a car. The driving with impairment scale includes 2 values: 0=no (min) and 1=yes (max). Higher scores mean a worse outcome.|3 month||||score on a scale||Standard Deviation|Mean
2554036|NCT02764190|Primary|Condom and/or Birth Control Use|Adolescent self-reported condom use with sexual intercourse in the past 3 months and/or use of birth control at last sexual intercourse. Two questions were used for this category. These questions were asked only to sexually active youth. The condom use scale includes 4 values: 1=always (min), 2=often, 3=sometimes, 4=never (max). Higher scores mean a worse outcome. The birth control scale includes 2 values: 0=no (min), 1=yes (max). Higher scores mean a better outcome.|3 months||||score on a scale||Standard Deviation|Mean
2554037|NCT02764190|Primary|Texting While Driving|Adolescent self-reported endorsement of texting while driving in the past 3 months. This question is only asked among adolescents who drive a car. The texting while driving scale includes 4 values: 1=never (min), 2=sometimes, 3=usually, or 4=always (max). Higher scores mean a worse outcome.|3 months||||score on a scale||Standard Deviation|Mean
2554038|NCT02764190|Primary|Helmet Use|Adolescent self-reported frequency of helmet use while bicycling in the past 3 months. The helmet use scale includes 4 values: 1=never (min), 2=sometimes, 3=usually, or 4=always (max). Higher scores mean a better outcome.|3 months||||score on a scale||Standard Deviation|Mean
2554039|NCT02764190|Primary|Seatbelt Use|Adolescent self-reported frequency of seatbelt use in a car in the past 3 months. The seatbelt use scale includes 4 values: 1=never (min), 2=sometimes, 3=usually, or 4=always (max). Higher scores mean a better outcome.|3 month||||score on a scale||Standard Deviation|Mean
2554040|NCT02764190|Primary|Depression|Adolescent self-reported depression as measured on the nine item Patient Health Questionnaire (PHQ-9) in the past 2 weeks. The PHQ-9 depression scale includes 28 values: 0 (min) to 27 (max). Higher scores mean a worse outcome.|3 month||||score on a scale||Standard Deviation|Mean
2554041|NCT02764190|Primary|Other Drug Consumption|Adolescent self-reported use of other drugs in the past 3 months. The other drug score includes 2 values: 0=no (min) and 1=yes (max). Higher scores mean a worse outcome.|3 months||||score on a scale||Standard Deviation|Mean
2554042|NCT02764190|Primary|Marijuana Consumption|Adolescent self-reported number of days using marijuana in the past month. The marijuana frequency scale includes 31 values: 0 (min) to 30 (max) days in the past month. Higher scores mean a worse outcome.|3 months||||score on a scale||Standard Deviation|Mean
2554043|NCT02764190|Primary|Alcohol Consumption (Quantity)|Adolescent self-reported number of drinks during a typical drinking episode in the prior month. The alcohol quantity scale includes 16 values from 0 (min) to 15+ (max). Higher score means a worse outcome.|3 months||||score on a scale||Standard Deviation|Mean
2554044|NCT02764190|Primary|Alcohol Consumption (Frequency)|Adolescent self-reported number of days of alcohol consumption in the past month. Alcohol frequency scale includes 31 values: 0 (min) to 30 (max) days in the past month. Higher scores mean a worse outcome.|3 months||||score on a scale||Standard Deviation|Mean
2554046|NCT02764190|Primary|Physical Activity|Adolescent self-reported number of days with >60 minutes of physical activity in an average week in the past 3 months. The physical activity scale includes 8 values: 0 (min) to 7 (max). Higher scores mean a better outcome.|3 month||||score on a scale||Standard Deviation|Mean
2554047|NCT02764190|Primary|Fruit and Vegetable Consumption|Adolescent self-reported number of fruits and vegetables consumed in a typical day in the past 3 months. The fruits and vegetables scale includes 6 values: 0 (min), 1, 2, 3, 4, or 5+ (max). Higher scores mean a better outcome.|3 month||||score on a scale||Standard Deviation|Mean
2554048|NCT02764190|Primary|Sweetened Beverage Consumption|Adolescent self-reported number of sweetened beverages consumed in a typical day in the past 3 months. The sweetened beverages scale includes 4 values: 0 (min), 1, 2, or 3+ (max) sweetened beverages per day. Higher scores mean a worse outcome.|3 month||||score on a scale||Standard Deviation|Mean
2554049|NCT02764190|Primary|Number of Health Risk Behaviors|"The risk behavior scale includes 22 values: 0 (min) to 21 (max). Higher scores indicate a worse outcome. Endorsement of any of the following counts as 1 (moderate risk) or 2 (high risk) on the scale depending on response and participant: ≥2 sugar-sweetened beverages consumed during typical day; ≤3 servings fruits/vegetables consumed during typical day; ≤3 days with 60+ minutes exercise during typical week; texting while driving in past 3 months; ≤7 hrs of sleep during typical night; not always using seatbelt; not always using helmet when bicycling; having driven under the influence of substances; tobacco use; days alcohol consumption in last 30 days (risk based on age) and/or number of drinks per drinking episode (risk based on age & sex); days marijuana consumption in last 30 days (risk based on age) and/or other drug use in past 3 months; not using birth control during last sexual intercourse and/or not always using a condom; & score of ≥10 on PHQ-9 depression."|3 month||||score on a scale||Standard Deviation|Mean
2554050|NCT02764151|Secondary|Plasma Endogenous Kynurenine/Tryptophan Ratio [Part 1]|The Kynurenine/Tryptophan ratio was determined by 1000*Kynurenine/Tryptophan.|Cycle 1 Day 1 pre-dose, and 1, 2, 4, 6, 8, 24 hours post-dose; Cycle 1 Day 4 and Day 8 pre-dose; Cycle 1 Day 15 pre-dose, and 1, 2, 4, 6, 8, 24 hours post-dose|The “Number of Participants Analyzed” represents the total number of participants in the treatment group in the indicated population on Cycle 1 Day. The “Number Analyzed” represents the number of participants contributing to the summary statistics at the end of treatment.|||ratio||Standard Deviation|Mean
2554051|NCT02764151|Secondary|Plasma Kynurenine and Tryptophan [Part 1]|The levels of Kynurenine and Tryptophan in blood samples were determined using the qualified analytical method.|Cycle 1 Day 1 pre-dose, and 1, 2, 4, 6, 8, 24 hours post-dose; Cycle 1 Day 4 and Day 8 pre-dose; Cycle 1 Day 15 pre-dose, and 1, 2, 4, 6, 8, 24 hours post-dose|The analysis population was the total number of participants in the treatment group in the indicated population.|||micromolar||Standard Deviation|Mean
2554052|NCT02764151|Secondary|Steady-State Trough Level Ratio [Part 1]|Steady-State trough level ratio was determined by cerebrospinal fluid (CSF)/Plasma. CSF/Plasma ratio was calculated based on the unbound concentration of each analyte. The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|Baseline and Day 15|The “Overall Number of Participants Analyzed” represents the total number of participants in the treatment group in the indicated population. The “Number Analyzed” represents the number of participants contributing to the summary statistics, i.e. number of participants where CSF/Plasma ratio was determined.|||ratio||Standard Deviation|Mean
2554053|NCT02764151|Secondary|Multiple Dose: Steady State Accumulation Ratio (Rss) of PF-06840002 and PF-06840001 [Part 1]|Rss of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by AUCtau (steady state) / AUCinf (single dose). The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post|The “Overall Number of Participants Analyzed” represents the total number of participants in the treatment group in the indicated population. The “Number Analyzed” represents the number of participants contributing to the summary statistics, i.e. number of participants where Rss was determined.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2554054|NCT02764151|Secondary|Multiple Dose: Observed Accumulation Ratio (Rac) of PF-06840002 and PF-06840001 [Part 1]|Rac of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by AUCtau (steady state) / AUCtau (single dose).|Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post|The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2554055|NCT02764151|Secondary|Multiple Dose: Apparent Volume of Distribution (Vz/F) of PF-06840002 and PF-06840001 [Part 1]|Vz/F of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by Dose/(AUC*kel). AUC is the area under concentration curve and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve. The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post|The “Overall Number of Participants Analyzed” represents the total number of participants in the treatment group in the indicated population. The “Number Analyzed” represents the number of participants contributing to the summary statistics, i.e. number of participants where Vz/F was determined.|||Liter||Full Range|Median
2554056|NCT02764151|Secondary|Multiple Dose: Apparent Clearance (CL/F) of PF-06840002 and PF-06840001 [Part 1]|CL/F of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by Dose/Area under the concentration-time profile from time 0 extrapolated to infinite time (AUCinf).|Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post|The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2554057|NCT02764151|Secondary|Multiple Dose: Average Concentration for the Dosing Interval (Cav) of PF-06840002 and PF-06840001 [Part 1]|Cav of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was observed directly from data.|Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post|The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2554058|NCT02764151|Secondary|Multiple Dose: Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06840002 and PF-06840001 [Part 1]|Cmin of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was observed directly from data.|Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post|The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|||ng/mL||Standard Deviation|Mean
2554059|NCT02764151|Secondary|Multiple Dose: Terminal Half-Life (t1/2) of PF-06840002 and PF-06840001 [Part 1]|t1/2 of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log linear decline were used in the regression. The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post|The “Overall Number of Participants Analyzed” represents the total number of participants in the treatment group in the indicated population. The “Number Analyzed” represents the number of participants contributing to the summary statistics, i.e. number of participants where t1/2 was determined.|||hr||Full Range|Median
2554060|NCT02764151|Secondary|Multiple Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06840002 and PF-06840001 [Part 1]|AUCtau of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by linear/log trapezoidal method.|Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post|The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2554061|NCT02764151|Secondary|Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06840002 and PF-06840001 [Part 1]|Tmax of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) were observed directly from data as time of first occurence.|Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post|The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|||hr||Full Range|Median
2554062|NCT02764151|Secondary|Multiple Dose: Maximum Observed Plasma Concentration (Cmax) of PF-06840002 and PF-06840001 [Part 1]|Cmax of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) were observed directly from data.|Cycle 1 Day 15 pre-dose, 1, 2, 4, 6, 8, 24 hrs post|The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2554063|NCT02764151|Secondary|Single Dose: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06840002 and PF-06840001 [Part 1]|AUCinf of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by AUClast + (Clast/kel), where AUClast is the area under the concentration-time profile from time zero to the time of the last quantifiable concentration, Clast is the predicted serum concentration at the last quantifiable time point estimated from the log linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve. The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose|The “Overall Number of Participants Analyzed” represents the total number of participants in the treatment group in the indicated population. The “Number Analyzed” represents the number of participants contributing to the summary statistics, i.e. number of participants where AUCinf was determined.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2554064|NCT02764151|Secondary|Single Dose: Terminal Half-Life (t1/2) of PF-06840002 and PF-06840001 [Part 1]|t1/2 of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log linear decline were used in the regression. The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose|The “Overall Number of Participants Analyzed” represents the total number of participants in the treatment group in the indicated population. The “Number Analyzed” represents the number of participants contributing to the summary statistics, i.e. number of participants where t1/2 was determined.|||hr||Standard Deviation|Mean
2554065|NCT02764151|Secondary|Single Dose: Apparent Volume of Distribution (Vz/F) of PF-06840002 and PF-06840001 [Part 1]|Vz/F of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by Dose/(AUC*kel). AUC is the area under concentration curve and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve. The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose|The “Overall Number of Participants Analyzed” represents the total number of participants in the treatment group in the indicated population. The “Number Analyzed” represents the number of participants contributing to the summary statistics, i.e. number of participants where Vz/F was determined.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2554066|NCT02764151|Secondary|Single Dose: Apparent Clearance (CL/F) of PF-06840002 and PF-06840001 [Part 1]|CL/F of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by Dose/Area under the concentration-time profile from time 0 extrapolated to infinite time (AUCinf). The analysis population included all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose|The “Overall Number of Participants Analyzed” represents the total number of participants in the treatment group in the indicated population. The “Number Analyzed” represents the number of participants contributing to the summary statistics, i.e. number of participants where CL/F was determined.|||Milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
2554289|NCT02760602|Secondary|Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT)|The FCSRT is a neuropsychological test of memory under conditions that control attention and cognitive processing in order to obtain an assessment of memory unconfounded by normal age-related changes in cognition.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
2554067|NCT02764151|Secondary|Single Dose: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06840002 and PF-06840001 [Part 1]|AUCtau of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by linear/log trapezoidal method.|Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose|The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2554068|NCT02764151|Secondary|Single Dose: Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-06840002 and PF-06840001 [Part 1]|AUClast of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) was determined by linear/log trapezoidal method.|Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose|The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2554069|NCT02764151|Secondary|Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06840002 and PF-06840001 [Part 1]|Tmax of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) were observed directly from data as time of first occurence.|Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose|The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|||hour (hr)||Full Range|Median
2554070|NCT02764151|Secondary|Single Dose: Maximum Observed Plasma Concentration (Cmax) of PF-06840002 and PF-06840001 [Part 1]|Cmax of PF-06840002 (Active Enantiomer) and PF-06840001 (Inactive Enantiomer) were observed directly from data.|Cycle 1 Day 1 pre-dose, 1, 2, 4, 6, 8, 24 and 72 hours post Cycle 1 Day 1 dose|The analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2554071|NCT02764151|Secondary|Number of Participants With Clinically Significant Findings in Vital Signs [Part 1]|Vital signs included measurements of blood pressure and temperature (oral, tympanic, temporal or axillary). The investigator judged any clinically significant vital signs findings.|Baseline up to 1 year|All Part 1 enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2554072|NCT02764151|Secondary|Number of Participants With Chemistries Laboratory Abnormalities by Severity (as Graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Event [CTCAE] Version 4.03) [Part 1]|Following parameters were analyzed for chemistry laboratory test: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose (non-fasted), albumin, and phosphorous or phosphate. Laboratory abnormalities were graded per NCI CTCAE version 4.03 and those with at least 1 participant are presented here.|Baseline up to 1 year|All Part 1 enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2554073|NCT02764151|Secondary|Number of Participants With Hematology Laboratory Abnormalities by Severity (as Graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Event [CTCAE] Version 4.03) [Part 1]|Following parameters were analyzed for hematology laboratory test: hemoglobin, platelets, white blood cell (WBC), absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, and absolute basophils. Laboratory abnormalities were graded per NCI CTCAE version 4.03 and those with at least 1 participant are presented here.|Baseline up to 1 year|All Part 1 enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2554074|NCT02764151|Secondary|Disease Control Rate (DCR) Based on the Immunotherapy Response Assessment for Neuro-Oncology (iRANO) Criteria [Part 1]|Disease control rate (DCR) was defined as the percentage of patients achieving CR, PR, or stable disease (SD). Overall DCR was based on iRANO criteria: CR: complete disappearance of all enhancing measurable and non-measurable disease on consecutive MRI at least 4 weeks apart, off steroid, sustained for at least 4 weeks; PR: >=50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; SD: does not qualify for CR, PR, or progression disease, and stable clinically.|Weeks 8, 16, and 24|The analysis population included all the participants enrolled.|||percentage of participants||95% Confidence Interval|Number
2554075|NCT02764151|Secondary|Objective Response Rate (ORR) [Part 1]|Objective response rate (ORR), defined as the percentage of patients achieving complete response (CR) or partial response (PR) as assessed by Macdonald criteria: CR: complete disappearance of all enhancing measurable and non-measurable disease on consecutive MRI at least 4 weeks apart, off steroid, sustained for at least 4 weeks; PR: >=50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks.|Weeks 8, 16, and 24|The analysis population included all the participants enrolled.|||Percentage of Participants||95% Confidence Interval|Number
2554076|NCT02764151|Primary|Number of Participants With TEAEs by Severity (as Graded by National Cancer Institute [NCI] Common Terminology Criteria for Adverse Event [CTCAE] Version 4.03) [Part 1]|Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.|Baseline up to 1 year|All Part 1 enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2554077|NCT02764151|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Part 1]|An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were those with initial onset or increasing in severity after the first dose of study treatment.|Baseline up to 1 year|All Part 1 enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2554290|NCT02760602|Secondary|Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)|RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial/constructional skills.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
2554078|NCT02764151|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) [Part 1]|DLTs: Any of the following adverse events (AE) occurring in the first cycle of treatment, unless there is a clear alternative explanation. Hematologic: Grade (Gr) 4 neutropenia lasting >=5 days; febrile neutropenia; Gr>=3 neutropenic with infection; Gr>=3 thrombocytopenia with bleeding; Gr 4 thrombocytopenia. Non-Hematologic: Any toxicity attributable to PF-06840003 that resulted in administration of less than 80% of the planned doses during Cycle 1; Gr 4 non-hematologic AE; Gr 3 AE lasting >7 days despite optimal supportive care; Gr 3 central nervous system (CNS) AE regardless of duration; Gr 3 QTc prolongation (QTc >500 milliseconds) (a DLT only if persisting after correction of any reversible causes); Concurrent aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3*upper limit of normal (ULN) and total bilirubin >2*ULN.|Baseline to Day 28|All Part 1 enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2554079|NCT02763865|Primary|Mean TRS (Tremor Rating Score) at 12 Week Followup|Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)|12-week followup(visit 20)||||units on a scale||Standard Deviation|Mean
2554080|NCT02763865|Primary|Mean TRS (Tremor Rating Score) at 8 Week Followup|Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)|8 week followup (visit 19)||||units on a scale||Standard Deviation|Mean
2554081|NCT02763865|Primary|Mean TRS (Tremor Rating Score) at 4 Week Followup|Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)|4 week followup(visit 18)||||units on a scale||Standard Deviation|Mean
2554082|NCT02763865|Primary|Mean TRS (Tremor Rating Score)|Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)|Baseline (Visit 2) post intervention||||units on a scale||Standard Deviation|Mean
2554083|NCT02763644|Secondary|Non-relapse Mortality|Time to non-relapse-related mortality up to 17 weeks was not assessed due to the paucity of data. Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference.|52 weeks|Only 7 adult patients were enrolled prior to the early study termination. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference and no data was reported.||||||
2554084|NCT02763644|Secondary|Complete Response Rate at 17 Weeks|Complete response rate was planned to be assessed at 17 weeks. However, due to early termination and low sample size the comparison between the two treatment arms LFG316 and SoC was not performed. Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference.|17 weeks|Only 7 adult patients were enrolled prior to the early study termination. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference and no data was reported.||||||
2554085|NCT02763644|Secondary|Time to Reach the Maximal Concentration (Tmax)|Time to reach the maximal concentration (Tmax)Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference therefore only summary statistics of serum PK values at Day 1|Day 1|Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference.|||hours||Full Range|Median
2554086|NCT02763644|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC Last)|Area under the plasma concentration versus time curve (AUC last) AUC up to the last measurable concentration. Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference therefore only summary statistics of serum PK values at Day 1|Day 1|Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference.|||h*μg/mL||Standard Deviation|Mean
2554087|NCT02763644|Secondary|Peak Plasma Concentration (Cmax)|Peak plasma concentration (Cmax) Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference therefore only summary statistics of serum PK values at Day 1 and not at 52 Weeks|Day 1|Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference.|||ng/mL||Standard Deviation|Mean
2554088|NCT02763644|Primary|Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks|Hematological response rate was to be assessed at 17 weeks. However, due to early termination and with too few patients for statistical inference, the comparison between the two treatment arms LFG316 and SoC was not performed, and only descriptive statistics at different visits are provided for schistocytes Schistocytes <2/microscopic high power field (HPF) showed a hematological response|17 weeks|Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference.|||Number of Schistocytes per 1,000 RBCs||Standard Deviation|Mean
2554089|NCT02763579|Secondary|Plasma Concentration of Etoposide||Predose (0 H) and 5-10 minutes before end/1 H and 4H after end of etoposide infusion (infusion duration = 1 H) on D1 of C1 and C3 (cycle = 21 days)(up to approximately 46 months)||2021-03-31|03/2021||||
2554090|NCT02763579|Secondary|Plasma Concentration of Carboplatin||Predose (0 H) and 5-10 minutes before end/1 H after end of carboplatin infusion (infusion duration = 1 H) on D1 of C1 and C3 (cycle = 21 days)(up to approximately 46 months)||2021-03-31|03/2021||||
2554091|NCT02763579|Secondary|Minimum Observed Serum Concentration (Cmin) of Atezolizumab|Atezolizumab infusion duration is 60 minutes for the first infusion and 30 minutes for subsequent infusions.|Predose (0 H) on D1 of C1, 2, 3, 4, 8, 16, and Q8C thereafter (cycle = 21 days) until treatment discontinuation (up to 46 months) and 120 days after last dose (up to approximately 46 months overall)||2021-03-31|03/2021||||
2554092|NCT02763579|Secondary|Maximum Observed Serum Concentration (Cmax) of Atezolizumab|Atezolizumab infusion duration is 60 minutes for the first infusion and 30 minutes for subsequent infusions.|Predose (0 H) and postdose (0.5 H) on D1 of C1; predose (0 H) on D1 of C2, 3, 4, 8, 16, and Q8C thereafter (cycle = 21 days) until treatment discontinuation (up to 46 months) and 120 days after last dose (up to approximately 46 months overall)||2021-03-31|03/2021||||
2554093|NCT02763579|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATAs)||Predose (0 hours [H]) on Day (D) 1 of Cycles (C) 1, 2, 3, 4, 8, 16, and every 8 cycles (Q8C) thereafter (cycle = 21 days) until treatment discontinuation (up to 46 months) and 120 days after last dose (up to approximately 46 months overall)||2021-03-31|03/2021||||
2554094|NCT02763579|Secondary|Percentage of Participants With Adverse Events||Baseline until up to 90 days after end of treatment (up to approximately 46 months)||2021-03-31|03/2021||||
2554095|NCT02763579|Secondary|TTD Per EORTC QLQ Lung Cancer Module (LC13) Score||Baseline until deterioration per symptom subscale (up to approximately 46 months)||2021-03-31|03/2021||||
2554096|NCT02763579|Secondary|Time to Deterioration (TTD) Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30) Score||Baseline until deterioration per symptom subscale (up to approximately 46 months)||2021-03-31|03/2021||||
2554097|NCT02763579|Secondary|Percentage of Participants Alive at 1 Year and 2 Years||1 year, 2 years (up to approximately 46 months)||2021-03-31|03/2021||||
2554098|NCT02763579|Secondary|Percentage of Participants Alive and Without PD, as Assessed by the Investigator Using RECIST v1.1, at 6 Months and 1 Year||6 months, 1 year (up to approximately 46 months)||2021-03-31|03/2021||||
2554099|NCT02763579|Secondary|Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1||First occurrence of PR or CR until PD or death, whichever occurs first (up to approximately 46 months)||2021-03-31|03/2021||||
2554100|NCT02763579|Secondary|Percentage of Participants With Objective Response (OR) as Assessed by the Investigator Using RECIST v1.1||Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 46 months)||2021-03-31|03/2021||||
2554101|NCT02763579|Primary|Duration of Overall Survival (OS)||Baseline until death from any cause (up to approximately 23 months)||||Months||95% Confidence Interval|Median
2554102|NCT02763579|Primary|Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least 20% increase in the sum of the longest diameter of target lesions compared to baseline, or unequivocal progression in non-target lesion(s), or the appearance of new lesion(s).|Baseline until PD or death, whichever occurs first (up to approximately 23 months)||||Months||95% Confidence Interval|Median
2554103|NCT02763566|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve of Abemaciclib, Its Metabolites (M2 & M20)|"Pharmacokinetics (PK): Area Under the Concentration Curve of Abemaciclib and its Metabolites LSN2839567 (M2) & LSN3106726 (M20) was reported.~C=Cycle, D=day;"|C1D1 post dose, C2D1 post dose, C3D1 predose, C4D1 predose|All randomized participants who received at least one dose of Abemaciclib and had evaluable PK data.|||Nanogram*hour per Millilitre (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2554104|NCT02763566|Secondary|Change From Randomization in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)|"consists of 30 items covered by 1 of 3 dimensions:~Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent).~Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much)~Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much).~Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function/QOL or higher levels of symptom burden."|Baseline through 19 Months|All randomized participants who received at least one dose of study drug and had baseline EORTC-QLQ-C30 measurement.|||score on a scale||Standard Error|Least Squares Mean
2554105|NCT02763566|Secondary|Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months [Clinical Benefit Rate (CBR)]|Clinical benefit rate (CBR) is the percentage of participants with a BOR of CR or PR, or SD for at least 6 months. CR is defined as the disappearance of all target and non-target lesions & no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.|Randomization to Measured Progressive Disease (up to 26 Months)|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2554106|NCT02763566|Secondary|Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)]|Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.|Randomization to Measured Progressive Disease (up to 26 Months)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2554107|NCT02763566|Secondary|Duration of Response (DoR)||Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 38 Months)|||||||
2554410|NCT02758132|Secondary|Measure Time (Months) to Skeletal Related Event (SRE) of Patients on Therapy||Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment|Patient expired before completing study||||||
2554108|NCT02763566|Secondary|Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|Objective response rate is the percentage of participants with a BOR of CR or PR as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.|Randomization to Measured Progressive Disease (up to 26 Months)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2554109|NCT02763566|Secondary|Overall Survival (OS)||Randomization to Date of Death from Any Cause (Estimated up to 38 Months)|||||||
2554110|NCT02763566|Secondary|Progression Free Survival (PFS) (Abemaciclib + Fulvestrant and Placebo + Fulvestrant Arms)|Progression-free survival time was measured from randomization until the date of objective progression as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), or death from any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Patients who have neither progressed nor died were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available.|Randomization to Measured Progressive Disease or Death (up to 26 Months)|"All randomized participants in Abemaciclib + Fulvestrant and Placebo + Fulvestrant arms.~Censored participants: 58 in Abemaciclib + Fulvestrant, 17 in Placebo + Fulvestrant."|||Months||95% Confidence Interval|Median
2554111|NCT02763566|Primary|Progression Free Survival (PFS) (Abemaciclib + NSAI & Placebo NSAI)|Progression-free survival time was measured from randomization until the date of objective progression as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), or death from any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Patients who have neither progressed nor died were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available.|Randomization to Measured Progressive Disease or Death (up to 26 Months)|All randomized participants in Abemaciclib + NSAI & Placebo NSAI arms. Censored participants: 141 in Abemaciclib + NSAI, 46 in Placebo + NSAI.|||Months||95% Confidence Interval|Median
2554112|NCT02763254|Secondary|Adverse Events|Adverse events will be recorded from the time of the first investigational cell product dose is administered until 30 days after the last administration. Serious events recorded for up to 1 year after administration.|1 year||||Participants|||Count of Participants
2554113|NCT02763254|Primary|Best Overall Response|Best single observed response, complete response (CR) or partial response (PR) per Lugano 2014 Disease Response Criteria, during 12 month follow-up.|1 year|Subject was withdrawn early before first disease assessment timepoint.||||||
2554114|NCT02763189|Secondary|Performance Score|The performance score is obtained form the performance Score Sheet that includes 15 actions, 1 point is given for each completed action. The minimum score is 0, the maximum score is 15. Higher scores relate to better performance.|immediately after the procedure||||units on a scale||Full Range|Mean
2554115|NCT02763189|Primary|Apnea Time|Apnea time was measured in seconds from the time the ventilator was disconnected from the original endotracheal tube to the time the ventilator was connected to the new endotracheal tube immediately after procedure.|immediately after the procedure||||seconds||Full Range|Mean
2554116|NCT02763124|Secondary|Spectacle Independence at Distance|Percentage of subjects that do not rely on spectacles for distance vision|60 days (+/- 10 days) after laser treatment|There were 28 eyes of 18 subjects treated in the study. Spectacle independence is evaluated by subject, not eye.|||Participants|||Count of Participants
2554117|NCT02763124|Secondary|Change in Refractive Cylinder|The vector change in refractive cylinder in diopters|60 days (+/- 10 days) after laser treatment||||diopters|Eyes|Standard Deviation|Mean
2554118|NCT02763124|Secondary|Change in Corneal Astigmatism|Vector change in the astigmatism measured on the cornea, in diopters|60 days (+/- 10 days) after laser treatment||||diopters|Eyes|Standard Deviation|Mean
2554119|NCT02763124|Primary|Uncorrected Monocular Distance Visual Acuity|Uncorrected monocular distance visual acuity, measured on a logMAR scale, (logarithm of the Minimum Angle of Resolution) which is a measure of visual acuity in which the smaller values indicate better visual acuity.|60 days (+/- 10 days) after laser treatment||||logMAR|Eyes|Standard Deviation|Mean
2554120|NCT02762877|Secondary|Characterize the Detection of EGFR T790M Alterations in Plasma in Patients Progressing on EGFR Targeting Therapy (Erlotinib, Gefitinib, Afatinib).||At time of plasma testing|T790M EGFR SNVs were detected in 6 out of 19 total cohort B patients (non-squamous NSCLC who are progressing on erlotinib, gefitinib, or afatinib).|||percentage of participants|||Number
2554121|NCT02762877|Secondary|Assess Concordance of Genomic Alterations in ALK (EML4-ALK Fusions) Detected in Plasma Versus Tumor Tissue.||Tumor tissue testing to plasma testing|Ten patients had ALK translocations detected in tissue, five of whom had ALK alterations detected in liquid|||Overall percent agreement (OPA)||95% Confidence Interval|Number
2554122|NCT02762877|Primary|EGFR Detected in Plasma Versus Tumor Tissue in Stage IV Non Squamous NSCLC Patients Who Are Newly Diagnosed or Progressing on Treatment|Assess concordance of genomic alterations in EGFR detected in plasma versus tumor tissue in stage IV non squamous NSCLC patients who are newly diagnosed or progressing on treatment.|Tumor tissue testing to plasma testing||||Overall percent agreement (OPA)||95% Confidence Interval|Number
2554123|NCT02762799|Secondary|Proportion of Patients With Binding or Neutralizing Antibodies to Filgrastim|Proportion of patients who had developed binding or neutralizing antibodies to filgrastim after single injection.|0 to 336 hours post-dose||||Participants|||Count of Participants
2554124|NCT02762799|Secondary|Frequency of Preliminary Withdrawal Due to AE/SAE||0 to 336 hours post-dose||||Participants|||Count of Participants
2554411|NCT02758132|Primary|Measure Change in Serum-based Metabolites Associated With Bone Deposition, Growth and Turnover in Patients Who Have CRPC With Clinical Evidence of Metastatic Disease to the Bone, All Using Gas Chromatography-time-of-flight Mass Spectrometry (GC-TOFMS).||Prior to Registration, Registration, Day 1 of cycle 4 and 13|Patient expired before completing study||||||
2554125|NCT02762799|Secondary|Frequency of AE/SAE 3-4 Grade CTCAE 4.03|"Grading scale of CTCAE 4.03~Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE:~Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.~Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL (activities of daily living).~Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.~Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE."|0 to 336 hours post-dose||||Participants|||Count of Participants
2554126|NCT02762799|Secondary|Frequency of Local Reactions||0 to 336 hours post-dose||||Participants|||Count of Participants
2554127|NCT02762799|Secondary|Overall Frequency of Adverse Events (AE)||0 to 336 hours post-dose||||Participants|||Count of Participants
2554128|NCT02762799|Secondary|Overall Frequency of Serious Adverse Events (SAE)||0 to 336 hours post-dose||||Participants|||Count of Participants
2554129|NCT02762799|Secondary|CD34-Emax|Maximal absolute count of CD34-cells after single filgrastim injection|0 to 336 hours post-dose||||cell per microliter||Standard Deviation|Mean
2554130|NCT02762799|Secondary|CD34-AUEC (0-336 Hours)|"Area Under Effect Curve (AUEC) effect - time from the moment of filgrastim injection to 336 hours based on CD-34 cells count (CD34)"|0 to 336 hours post-dose||||cell per microliter / hour||Standard Deviation|Mean
2554131|NCT02762799|Secondary|ANC-Emax|Maximal absolute neutrophil count after single filgrastim injection|0 to 336 hours post-dose||||cells х10^9 per liter||Standard Deviation|Geometric Mean
2554132|NCT02762799|Secondary|ANC-AUEC (0-336 Hours)|"Area Under Effect Curve (AUEC) effect - time from the moment of filgrastim injection to 336 hours based on absolute neutrophil count (ANC)"|0 to 336 hours post-dose||||cells х10^9 per liter/hour||Standard Deviation|Geometric Mean
2554133|NCT02762799|Secondary|Clearance|Clearance of filgrastim after single injection|0 to 48 hours post-dose||||ml per hour||Inter-Quartile Range|Median
2554134|NCT02762799|Secondary|Kel|The elimination rate constant after single injection of filgrastim|0 to 48 hours post-dose||||hour-1||Inter-Quartile Range|Mean
2554135|NCT02762799|Secondary|Т½|Half-life of filgrastim after single injection of filgrastim|0 to 48 hours post-dose||||hours||Inter-Quartile Range|Median
2554136|NCT02762799|Secondary|Tmax After Injection|Time after single injection to reach maximal concentration of filgrastim|0 to 48 hours post-dose||||hours||Inter-Quartile Range|Median
2554137|NCT02762799|Secondary|Cmax After Intravenous Injection|Maximal concentration of filgrastim after intravenous injection of filgrastim|0 to 48 hours post-dose||||picogram per ml||Standard Deviation|Geometric Mean
2554138|NCT02762799|Primary|Cmax After Subcutaneous Injection|Maximal concentration of filgrastim after subcutaneous injection of filgrastim|0 to 48 hours post-dose||||picogram per ml||Standard Deviation|Geometric Mean
2554139|NCT02762799|Primary|AUC (0-48 Hours)|"Area Under Curve (AUC) concentration - time from the moment of filgrastim injection to 48 hours"|0 to 48 hours post-dose||||picogram per ml / hour||Standard Deviation|Geometric Mean
2554140|NCT02762578|Secondary|Device Specific Questionnaires II (Would You Recommend the Pen?)|"Participants were asked the question would you recommend the pen? Number of participants reporting yes and no are presented. Missing data was imputed using last observed value."|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 2.|||Participants|||Count of Participants
2554141|NCT02762578|Secondary|Device Specific Questionnaires II (How Confident Are You That the Full Dose Has Been Delivered?)|Device Specific Questionnaires II (How confident are you that the full dose has been delivered?) was measured on following categories: Very confident, Fairly confident, Fairly easy, Rather confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 2.|||Participants|||Count of Participants
2554142|NCT02762578|Secondary|Device Specific Questionnaires II (How Easy or Difficult is it to Inject Yourself in Different Places of the Body Using This Pen?)|Device Specific Questionnaires II (How easy or difficult is it to inject yourself in different places of the body using this pen?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult, Very difficult and Not applicable. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 2.|||Participants|||Count of Participants
2554143|NCT02762578|Secondary|Device Specific Questionnaires II (How Easy/Difficult is it to Reach the Dose Button When Inject Your Insulin Dose?)|Device Specific Questionnaires II (How easy/difficult is it to reach the dose button when inject your insulin dose?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 2.|||Participants|||Count of Participants
2554144|NCT02762578|Secondary|Device Specific Questionnaires II (How Easy or Difficult is it to Inject Your Usual Insulin Dose?)|Device Specific Questionnaires II (How easy or difficult is it to inject your usual insulin dose?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 2.|||Participants|||Count of Participants
2554187|NCT02762578|Primary|Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)|Change from baseline in HbA1c after 26 weeks of treatment. The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate. Missing values imputed using last observed value.|At 26 weeks|Full analysis set. Number of subject analysed=subjects with available data for HbA1c|||percentage of HbA1c||Standard Error|Least Squares Mean
2554145|NCT02762578|Secondary|Device Specific Questionnaires II (How Easy or Difficult is it to Distinguish Between Dialling up and Down?)|Device Specific Questionnaires II (How easy or difficult is it to distinguish between dialling up and down?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 2.|||Participants|||Count of Participants
2554146|NCT02762578|Secondary|Device Specific Questionnaires II (How Easy or Difficult Was it to Learn How to Use This Pen?)|Device Specific Questionnaires II (How easy or difficult was it to learn how to use this pen?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 2.|||Participants|||Count of Participants
2554147|NCT02762578|Secondary|Device Specific Questionnaires I (Did You Have Any Problems Using the Pen?)|"Participants were asked to report whether they had any problems using the pen. Number of participants reporting yes and no are presented. Missing data was imputed using last observed value."|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.|||Participants|||Count of Participants
2554148|NCT02762578|Secondary|Device Specific Questionnaires I (How Comfortable do You Find the Handling of the Pen?)|Device Specific Questionnaires I (How comfortable do you find the handling of the pen?) was measured on following categories: Very comfortable, Fairly comfortable, Rather comfortable, Not very comfortable and Not at all comfortable. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.|||Participants|||Count of Participants
2554149|NCT02762578|Secondary|Device Specific Questionnaires I (How Convenient do You Find the Size of the Pen?)|Device Specific Questionnaires I (How convenient do you find the size of the pen?) was measured on following categories: Very convenient, Fairly convenient, Rather convenient, Not very convenient and Not at all convenient. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.|||Participants|||Count of Participants
2554150|NCT02762578|Secondary|Device Specific Questionnaires I (How Confident Are You That the Air Shot Has Been Done Correctly?)|Device Specific Questionnaires I (How confident are you that the air shot has been done correctly?) was measured on following categories: Very confident, Fairly confident, Rather confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.|||Participants|||Count of Participants
2554151|NCT02762578|Secondary|Device Specific Questionnaires I (How Suitable is the Pen to Use in Public?)|Device Specific Questionnaires I (How suitable is the pen to use in public?) was measured on following scale: Very suitable, Fairly suitable, Rather suitable, Not very suitable and Not at all suitable. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.|||Participants|||Count of Participants
2554152|NCT02762578|Secondary|Device Specific Questionnaires I (Overall, How Confident Are You in Controlling Your Blood Sugar Level Using This Pen?)|Device Specific Questionnaires I (Overall, how confident are you in controlling your blood sugar level using this pen?) was measured on following categories: Very confident, Fairly confident, Rather confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.|||Participants|||Count of Participants
2554153|NCT02762578|Secondary|Device Specific Questionnaires I (Overall, How Confident Are You in Your Management of Your Daily Insulin Injections Using This Pen?)|Device Specific Questionnaires I (Overall, how confident are you in your management of your daily insulin injections using this pen?) was measured on following categories: Very confident, Fairly confident, Rather confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.|||Participants|||Count of Participants
2554154|NCT02762578|Secondary|Device Specific Questionnaires I (How Confident Are You That You Inject the Correct Amount of Insulin Every Time?)|Device Specific Questionnaires I (How confident are you that you inject the correct amount of insulin every time?) was measured on following categories: Very confident, Rather confident, Fairly confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.|||Participants|||Count of Participants
2554155|NCT02762578|Secondary|Device Specific Questionnaires I (How Confident Are You That You Set the Insulin Dose Correctly Every Time?)|Device Specific Questionnaires I (How confident are you that you set the insulin dose correctly every time?) was measured on following categories: Very confident, Rather confident, Fairly confident, Not very confident and Not at all confident. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.|||Participants|||Count of Participants
2554223|NCT02762071|Secondary|Length of Hospital Stay|Duration of stay in hospital (hours) after shoulder replacement surgery.|At the time of discharge from hospital, Up to 4 days||||hours||Standard Deviation|Mean
2554156|NCT02762578|Secondary|Device Specific Questionnaires I (How Easy or Difficult is it to See the Dose Scale When Injecting?)|Device Specific Questionnaires I (How easy or difficult is it to see the dose scale when injecting?) was measured on following categories: Very confident, Very easy, Fairly easy, Neither easy nor difficult, Rather difficult, and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.|||Participants|||Count of Participants
2554157|NCT02762578|Secondary|Device Specific Questionnaires I (How Easy/Difficult is it to Know if the Push Button Has Been Pushed Completely Down?)|Device Specific Questionnaires I (How easy/difficult is it to know if the push button has been pushed completely down?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult or Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.|||Participants|||Count of Participants
2554158|NCT02762578|Secondary|Device Specific Questionnaires I (How Easy/Difficult is it to Turn the Dose Selector When Choosing the Right Dose?)|Device Specific Questionnaires I (How easy/difficult is it to turn the dose selector when choosing the right dose?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.|||Participants|||Count of Participants
2554159|NCT02762578|Secondary|Device Specific Questionnaires I (How Easy or Difficult is it to Push Down the Injection Button?)|Device Specific Questionnaires I (How easy or difficult is it to push down the injection button?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.|||Participants|||Count of Participants
2554160|NCT02762578|Secondary|Device Specific Questionnaires I (How Easy or Difficult is it to Feel the Clicks for Each Unit Increment?)|Device Specific Questionnaires I (How easy or difficult is it to feel the clicks for each unit increment?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.|||Participants|||Count of Participants
2554161|NCT02762578|Secondary|Device Specific Questionnaires I (How Easy or Difficult is it to Hear the Clicks for Each Unit Increment?)|Device Specific Questionnaires I (How easy or difficult is it to hear the clicks for each unit increment?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.|||Participants|||Count of Participants
2554162|NCT02762578|Secondary|Device Specific Questionnaires I (How Easy or Difficult do You Find it to Hold the Pen Stable When Injecting?)|Device Specific Questionnaires I (How easy or difficult do you find it to hold the pen stable when injecting?) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.|||Participants|||Count of Participants
2554163|NCT02762578|Secondary|Device Specific Questionnaires I (How Easy or Difficult is it to Read the Dose Scale)|Device Specific Questionnaires I (How easy or difficult is it to read the dose scale) was measured on following categories: Very easy, Fairly easy, Neither easy nor difficult, Rather difficult and Very difficult. Reported results are number of participants reporting the individual category of the question at week 26. Missing data was imputed using last observed value.|week 26|Full analysis set. Number of participants analysed=subjects with data available for Device specific questionnaire 1.|||Participants|||Count of Participants
2554164|NCT02762578|Secondary|Treatment Satisfaction Questionnaire (Treatment Related Impact Measures - Diabetes Device [TRIM-D Device])|TRIM-D device is an eight item measure with two domains assessing Device Bother and Device Function. This captures information on the ease of use, convenience, and handling of the device(s) used to take diabetes medication. The measure has acceptable reliability, validity and ability to detect change. The scores were transformed to a 0−100 scale with higher scores indicating less treatment related impact. Missing data was imputed using last observed value.|At week 26|Full analysis set. Number of subjects analysed=subjects with data available for TRIM-D device total score.|||units on a scale||Standard Deviation|Mean
2554165|NCT02762578|Secondary|Change in Treatment Satisfaction Questionnaire (Treatment Related Impact Measure-diabetes [TRIM-D])|Change from baseline in TRIM-D scores at week 26. TRIM-D score measured treatment satisfaction which included an overall score as well the subscale scores (daily life, diabetes management, compliance and psychological health). The scores were transformed to a 0−100 scale with higher scores indicating less treatment related impact. Missing data was imputed using last observed value.|Week 0, week 26|Full analysis set. Number of subjects analysed=subjects with data available for TRIM-D total score.|||units on a scale||Standard Deviation|Mean
2554166|NCT02762578|Secondary|Change in Health Related Quality of Life Questionnaire (SF -36)|Change from baseline in SF-36 at week 26. The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score). Missing data was imputed using last observed value.|Week 0, week 26|Full analysis set. Number of subjects analysed=subjects with data available for individual component of SF-36 questionnaire.|||units on a scale||Standard Deviation|Mean
2554167|NCT02762578|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes in the Maintenance Period|"Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose < 3.1 mmol/L (56 mg/dL) with or without symptoms. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. The nocturnal period was defined as the period between 00:01 and 05:59 a.m. (both inclusive). Maintenance period was defined as the period from week 16 to end of treatment, including 1 week follow-up.~Number of treatment emergent hypoglycaemic episodes were reported in terms of rate, defined as number of events divided by PYE multiplied by 100 (1 PYE=365.25 days)."|From week 16 to end of treatment (week 26) + 1 week follow-up|Safety analysis set|||hypoglycaemic episodes per 100 PYE|||Number
2554168|NCT02762578|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period|"Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose < 3.1 mmol/L (56 mg/dL) with or without symptoms. Severe: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Maintenance period was defined as the period from week 16 to end of treatment, including 1 week follow-up.~Number of treatment emergent hypoglycaemic episodes were reported in terms of rate, defined as number of events divided by PYE multiplied by 100 (1 PYE=365.25 days)."|From week 16 to end of treatment (week 26) + 1 week follow-up|Safety analysis set|||hypoglycaemic episodes per 100 PYE|||Number
2554169|NCT02762578|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition During 26 Weeks of Treatment|"ADA classification of hypoglycaemia:~Severe: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.~Asymptomatic: An episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG level ≤3.9 mmol/L.~Documented symptomatic: An episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG level ≤3.9 mmol/L.~Relative: An episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia, and interprets those as indicative of hypoglycaemia, but with a measured PG level >3.9 mmol/L.~Probable symptomatic: An episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG level ≤3.9 mmol/L.~Number of treatment emergent hypoglycaemic episodes were reported in terms of rate, defined as number of events divided by PYE multiplied by 100 (1 PYE=365.25 days)."|Week 0-26|Safety analysis set.|||hypoglycaemic episodes per 100 PYE|||Number
2554170|NCT02762578|Secondary|2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Within-subject Variability as Measured by Coefficient of Variance (CV)% After 26 Weeks of Treatment|The logarithm transformed SMPG values available before breakfast and main evening meal were analysed separately as repeated measures in a linear mixed model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age as covariate and subject as random factor. The model assumed independent within- and between-subject errors with variances depending on treatment. Within-subject variability as measured by CoV% for a treatment could be calculated from the corresponding residual variance.|At week 26|Full analysis set. Number of subjects analysed=subjects who contributed to this analysis.|||Coefficient of variation|||Number
2554171|NCT02762578|Secondary|2-point Profile (SMPG) Measurements Obtained Throughout the Trial for Dose Adjustment - Time From Randomisation (Measured in Weeks) to Achieve Titration Targets|2-point profiles (SMPG): pre-breakfast and pre-dinner (main evening meal) SMPGs were to be taken for titration/dose adjustments. The pre-specified titration targets were to achieve SMPG level <5 mmol/L (90 mg/dL) both before breakfast and before main evening meal. For each target, the time from randomisation to the date a subject achieves the titration target for the first time was derived (Kaplan-Meier method). Reported results are time to all titration target (pre-breakfast and pre-dinner) was met for the first time.|From randomization till achievement of titration target (up to week 26)|Full analysis set|||week||Inter-Quartile Range|Median
2554172|NCT02762578|Secondary|9-point Profile (SMPG) - Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment|SMPG values were recorded at 9 time-points: before and after (90 min after the start of the meal) breakfast, lunch, main evening meal, before bedtime, at 4 am and before breakfast on the next day. Missing values were imputed using last observed value. Prandial PG increment for each meal was derived from the 9-point profile (SMPG) as the difference between PG values after meal (90 min) and before meal. The reported results are mean prandial PG increment overall meals (the mean of all available meal increments).|At week 26|Full analysis set. Number of subjects analysed=subjects with SMPG values available before and after (90 min after the start of the meal) breakfast, lunch, main evening meal.|||mmol/L||Standard Deviation|Mean
2554173|NCT02762578|Secondary|Fluctuation in the 9-point Profile (SMPG) After 26 Weeks of Treatment|SMPG values were recorded at 9 time-points: before and after (90 min after the start of the meal) breakfast, lunch, main evening meal, before bedtime, at 4 am and before breakfast on the next day. Missing values were imputed using last observed value. Fluctuation in 9-point SMPG profile is the average absolute difference to the mean of the profile of the 9-point SMPG measurements accumulated over the profile.|At week 26|Full analysis set. Number of subjects analysed=subjects with available data for SMPG.|||mmol/L||Full Range|Median
2554174|NCT02762578|Secondary|Mean of the 9-point Profile (SMPG) After 26 Weeks of Treatment|SMPG values were recorded at 9 time-points: before and after (90 min after the start of the meal) breakfast, lunch, main evening meal, before bedtime, at 4 am and before breakfast on the next day. Missing values were imputed using last observed value. The mean of 9-point profile (SMPG) was defined as the area under the profile divided by the measurement time and was calculated using the trapezoidal method.|At week 26|Full analysis set. Number of subjects analysed=subjects with available data for SMPG.|||mmol/L||Standard Deviation|Mean
2554175|NCT02762578|Secondary|9-point Profile (SMPG) After 26 Weeks of Treatment|SMPG values were recorded at 9 time-points: before and after (90 min after the start of the meal) breakfast, lunch, main evening meal, before bedtime, at 4 am and before breakfast on the next day. Missing values were imputed using last observed value.|At week 26|Full analysis set. Number of subjects analysed=subjects with SMPG values available at individual timepoints.|||mmol/L||Standard Deviation|Mean
2554224|NCT02762071|Secondary|Opioid Medication Consumption in Morphine Milligram Equivalents|We analyzed intraoperative opioid consumption; postoperative opioid consumption at days 1, 2, 3, and 4; total opioid consumption at day 1 (intraoperative + postoperative day 1). This was measured in morphine milligram equivalents.|Up to 4 days postoperatively||||morphine milligram equivalents||Standard Deviation|Mean
2554176|NCT02762578|Secondary|Responder for HbA1c (HbA1c ≤6.5%) Without Severe Hypoglycaemic Episodes|A responder for HbA1c without severe hypoglycaemia was defined as a subject who meets the HbA1c target (≤6.5%) at end of trial without severe treatment emergent hypoglycaemia during the last 12 weeks of treatment or within 7 days after the last randomised treatment. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Missing HbA1c data was imputed using last observed value.|At week 26|Full analysis set. Number of subjects analysed=subjects who have been exposed for at least 12 treatment weeks.|||Participants|||Count of Participants
2554177|NCT02762578|Secondary|Responder for HbA1c (HbA1c ≤6.5%) Without Confirmed Hypoglycaemic Episodes|A responder for HbA1c without confirmed hypoglycaemia was defined as a subject who meets the HbA1c target (≤6.5%) at end of trial without treatment emergent confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days after the last randomised treatment. Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose < 3.1 mmol/L (56 mg/dL) with or without symptoms. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Missing data is imputed using last observed value.|At 26 weeks|Full analysis set. Number of subjects analysed=subjects who have been exposed for at least 12 treatment weeks.|||Participants|||Count of Participants
2554178|NCT02762578|Secondary|Responder for HbA1c (HbA1c <7%) Without Severe Hypoglycaemic Episodes|A responder for HbA1c without severe hypoglycaemia was defined as a subject who meets the HbA1c target (<7%) at end of trial without severe treatment emergent hypoglycaemia during the last 12 weeks of treatment or within 7 days after the last randomised treatment. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Missing HbA1c data was imputed using last observed value.|At week 26|Full analysis set. Number of subjects analysed=subjects who have been exposed for at least 12 treatment weeks.|||Participants|||Count of Participants
2554179|NCT02762578|Secondary|Responder for HbA1c (HbA1c <=6.5%) After 26 Weeks of Treatment|Number of subjects with HbA1c <=6.5% after 26 weeks of treatment. Missing HbA1c data was imputed using last observed value.|Week 26|Full analysis set.|||Participants|||Count of Participants
2554180|NCT02762578|Secondary|Responder for HbA1c (HbA1c <7%) After 26 Weeks of Treatment|Number of subjects with HbA1c <7% after 26 weeks of treatment. Missing HbA1c data was imputed using last observed value.|Week 26|Full analysis set.|||Participants|||Count of Participants
2554181|NCT02762578|Secondary|Incidence of Treatment Emergent Adverse Events (TEAEs)|A treatment emergent adverse event was defined as an episode that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Incidence of AEs was reported in terms of rate, defined as number of adverse events divided by patient years of exposure (PYE) multiplied by 100 (1 PYE=365.25 days).|Weeks 0-26|Safety analysis set included all subjects receiving at least one dose of IDegAsp or BIAsp.|||events per 100 PYE|||Number
2554182|NCT02762578|Secondary|Responder Without Confirmed Hypoglycaemic Episodes HbA1c Below 7.0%|A responder for HbA1c without confirmed hypoglycaemia was defined as a subject who meets the HbA1c target (<7.0%) at end of trial without treatment emergent confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days after the last randomised treatment. Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose < 3.1 mmol/L (56 mg/dL) with or without symptoms. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Missing data is imputed using last observed value.|At 26 weeks|Full analysis set. Number of subjects analysed=subjects who have been exposed for at least 12 treatment weeks.|||Participants|||Count of Participants
2554183|NCT02762578|Secondary|Change From Baseline in Body Weight|Change from baseline in body week at week 26. The response and change from baseline in response after 26 weeks are analysed using an ANCOVA model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate. Missing values imputed using last observed value.|Week 0, Week 26|Full analysis set. Number of subject analysed=subjects with data available for body weight.|||kg||Standard Error|Least Squares Mean
2554184|NCT02762578|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes|The number of events was analysed using a negative binomial model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate. Confirmed hypoglycaemia was defined as either severe episodes or episodes with plasma glucose < 3.1 mmol/L (56 mg/dL) with or without symptoms. A treatment emergent hypoglycaemic episode was defined as an episode that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.|Weeks 0-26|Full analysis set. Number of subjects analysed=subjects with data available for confirmed hypoglycaemic episodes.|||events per 100 patient years of exposure|||Number
2554185|NCT02762578|Secondary|Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes|The number of events was analysed using a negative binomial model with a log-link function and the logarithm of the exposure time (100 years) for which a hypoglycaemic episode is considered treatment emergent as offset. The model included treatment, anti-diabetic therapy at screening and sex as fixed factors, and age as covariate. Confirmed hypoglycaemia is defined as either severe episodes or episodes with plasma glucose < 3.1 mmol/L (56 mg/dL) with or without symptoms. The nocturnal period was defined as the period between 00:01 and 05:59 a.m. (both inclusive). A treatment emergent hypoglycaemic episode was defined as an episode that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.|Weeks 0-26|Full analysis set. Number of subjects analysed=subjects with data available for nocturnal confirmed hypoglycaemic episodes.|||events per 100 patient years of exposure|||Number
2554186|NCT02762578|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose)|Change from baseline in FPG at week 26. The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate. Missing values imputed using last observed value.|At 26 weeks|Full analysis set. Number of subject analysed=subjects with available data for FPG.|||mmol/L||Standard Error|Least Squares Mean
2554188|NCT02762500|Other Pre-specified|Number of Subjects With Type of Adverse Events (AEs) Serious Adverse Events (SAEs) and AEs That Led to Discontinuation of Treatment.|Adverse events (AEs) were collected from the time a subject signed the informed consent. Treatment-emergent adverse events (TEAEs) are AEs occurring or worsening after the first dose of study drug (LYC-30937-EC 25 mg or placebo). Adverse event severity was assessed by the Investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.03, with grading as follows: Grade 1 = mild (asymptomatic or mild symptoms), Grade 2 = moderate (minimal, local intervention, or noninvasive intervention indicated); Grade 3 = severe (or medically significant but not life-threatening); Grade 4 = life-threatening; Grade 5 = death.|10 weeks|Safety Set, consisting of all randomized subjects who took at least one dose of study drug.|||Participants|||Count of Participants
2554189|NCT02762500|Secondary|Percent Change From Baseline in Total Mayo Score at Week 8.|"Analyzes the change in total Mayo score score between baseline and Week 8 for all randomized subjects who had total Mayo score scores at both baseline and Week 8.~The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, endoscopy, physicians global assessment), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy scoring was performed centrally."|Baseline to Week 8|All randomized subjects randomized who had TMS scores at baseline and Week 8.|||Percent Change from baseline||Standard Error|Least Squares Mean
2554190|NCT02762500|Secondary|Percent Change From Baseline to Week 8 in Fecal Calprotectin in Subjects With Baseline Fecal Calprotectin ≥ 250 µg/g|Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.|Baseline to Week 8|All randomized subjects who had an elevated baseline fecal calprotectin level of ≥ 250 µg/g and who had both a baseline and Week 8 value.|||percent change from baseline||Standard Error|Least Squares Mean
2554191|NCT02762500|Secondary|Number of Subjects With a Clinical Response on the Total Mayo Score at Week 8.|"The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, endoscopy, physicians global assessment), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy scoring was performed centrally.~Clinical response on the total Mayo score at Week 8 was defined as a reduction from baseline total Mayo score of ≥ 3 points and ≥ 30%, and a decrease from baseline in rectal bleeding score of ≥ 1 point or absolute rectal bleeding score of ≤ 1 point."|8 weeks|The analysis population consisted of all randomized subjects (Full Analysis Set).|||Participants|||Count of Participants
2554192|NCT02762500|Secondary|Number of Subjects With a Clinical Response on the Modified Mayo Score at Week 8.|"The modified Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 9 points and consists of 3 subscores (stool frequency, rectal bleeding, endoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy scoring was performed centrally.~Clinical response on the modified Mayo score at Week 8 was defined as a reduction from the baseline modified Mayo score of ≥ 2 points and ≥ 25%, and a decrease from baseline in rectal bleeding score of ≥ 1 point or absolute rectal bleeding score of ≤ 1 point."|8 weeks|The analysis population consisted of all randomized subjects (Full Analysis Set).|||Participants|||Count of Participants
2554193|NCT02762500|Secondary|Number of Subjects Who Achieve Clinical Remission at Week 8 Using the Total Mayo Score.|"The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, endoscopy, physicians global assessment), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy scoring was performed centrally.~Clinical remission on the total Mayo Score is defined as a total Mayo score of ≤ 2, with no individual subscore > 1."|8 weeks|The analysis population consisted of all randomized subjects (Full Analysis Set).|||Participants|||Count of Participants
2554194|NCT02762500|Primary|Number of Subjects Who Achieve Clinical Remission at Week 8 Using Modified Mayo Score.|"The modified Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 9 points and consists of 3 subscores (stool frequency, rectal bleeding, endoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopy scoring was performed centrally.~Clinical remission on the modified Mayo score was defined as a Mayo stool frequency subscore of ≤ 1, Mayo rectal bleeding subscore of 0 and a Mayo endoscopy subscore of ≤ 1."|8 weeks|The analysis population consisted of all randomized subjects (Full Analysis Set).|||Participants|||Count of Participants
2554195|NCT02762370|Other Pre-specified|Change in Average Blood Glucose From Baseline (Hour -48 to Hour -1) to Hour 1 to Hour 48 for FX006 32 mg Relative to TCA IR 40 mg.||Baseline (Hour -48 to Hour -1) to Hour 1 to Hour 48||||mg/dL||Standard Error|Least Squares Mean
2554196|NCT02762370|Other Pre-specified|Change From Baseline for Maximum Blood Glucose: Baseline Average Blood Glucose (Hour −72 to Hour −1) to Maximum Blood Glucose (Hour 1 to Hour 72) for FX006 32 mg Relative to TCA IR 40 mg||Baseline (Hour -72 to Hour -1) to Hour 1 to Hour 72||||mg/dL||Standard Error|Least Squares Mean
2554197|NCT02762370|Other Pre-specified|Percent Time Blood Glucose Less Than 70 mg/dl, 70 - 180 mg/dl, 180.1 - 250.0 mg/dl, 250.1 - 350.0 mg/dl, and Greater Than 350.0 mg/dl||Baseline to Days 1-2||||Percentage of time|||Number
2554198|NCT02762370|Secondary|Area Under the Effect (AUE) Curves for Average Blood Glucose - FX006 Versus TCA IR||Baseline to 72 hours post injection (-72 hr, 0 hr, and 1, 2, 3, 7, and 15 days post-dose)||||hr*mg/dL||Standard Error|Least Squares Mean
2554199|NCT02762370|Secondary|Glycemic Variability Coeffecient of Variation (CV)|The glycemic variability was calculated as the coefficient of variation (CV) of the hourly averages in each of these time periods: Hour 1-24, Hour 1-48, Hour 1-72, Hour 1-168, and Hour 1-360. The % CV for each patient was derived using the formula: (SD/mean)*100, using the values for each hourly average glucose measurement over the time period. Average % CV in the FX006 40 mg group was compared to the TCA IR 40 mg group using a linear model (ANCOVA) with fixed effects for treatment group. Model covariates were study center and baseline (72-hour) blood glucose average.|Baseline to 72 hours post injection (hourly average blood glucose measurement over the time period)||||mg/dL||Standard Error|Least Squares Mean
2554225|NCT02762071|Primary|Visual Analog Scale Pain Score at 24 Hours Postoperatively|The primary outcome was pain score on a visual analog scale (VAS) at 24 hours postoperatively. VAS pain scores range from 0 (no pain) to 10 (unbearable pain).|At 24 hours after surgery||||score on a scale||Standard Deviation|Mean
2554200|NCT02762370|Secondary|Percent Time Blood Glucose Less Than 70 mg/dl, 70 - 180 mg/dl, 180.1 - 250.0 mg/dl, 250.1 - 350.0 mg/dl, and Greater Than 350.0 mg/dl|The glycemic variability was calculated as the coefficient of variation (CV) of the hourly averages in each of these time periods: Hour 1-24, Hour 1-48, Hour 1-72, Hour 1-168, and Hour 1-360. The % CV for each patient was derived using the formula: (SD/mean)*100, using the values for each hourly average glucose measurement over the time period. Average % CV in the FX006 40 mg group was compared to the TCA IR 40 mg group using a linear model (ANCOVA) with fixed effects for treatment group. Model covariates were study center and baseline (72-hour) blood glucose average.|Baseline to Days 1-3||||Percentage of time|||Number
2554201|NCT02762370|Primary|Change From Baseline for Average Blood Glucose (mg/dL)|Average blood glucose was analyzed with a mixed model for repeated measures (MMRM)|Baseline and 72 Hours post intra-articular (IA) injection||||mg/dL||Standard Error|Least Squares Mean
2554202|NCT02762331|Secondary|Development of Renal Calculi|We will assess for develop of renal calculi as a safety measure.|48 hours||||Participants|||Count of Participants
2554203|NCT02762331|Secondary|Lipidomic Biomarkers|Change in baseline lipidomic biomarkers including free fatty acids, eicosanoids, 3-polyunsaturated fatty acid-derived lipid mediators, phospholipid substrates of cytosolic PLA2α, and isoprostanes will be measured at 6- and 24 hours following administration of the study drug.|24 hours|Samples were collected but not analyzed due to study termination. This study was terminated because the therapy was proven effective by larger studies.||||||
2554204|NCT02762331|Secondary|Coagulation Biomarkers|Change in baseline coagulation biomarkers including thrombomodulin, fibrinogen, platelets and clotting parameters from thromboelastography will be measured at 6, 24, and 48 hours following the first administration of the study drug.|48 hours|Samples were collected but not analyzed due to study termination. This study was terminated because the therapy was proven effective by larger studies.||||||
2554205|NCT02762331|Secondary|Occurence of Atrial Fibrillation|Atrial fibrillation is a common complication of CABG surgery. We will monitor EKG status for development of atrial fibrillation for 48 hours post-op.|48 hours||||Participants|||Count of Participants
2554206|NCT02762331|Primary|Urinary Inflammatory Biomarker|Change in baseline urine concentrations for neutrophil gelatinase-associated lipocalin (NGAL) will be measured at 6 and 24 hours.|24 hours|Samples were collected but not analyzed due to study termination. This study was terminated because the therapy was proven effective by larger studies.||||||
2554207|NCT02762331|Primary|Plasma Inflammatory Biomarkers|Change in baseline inflammatory biomarkers including TNF-alpha, C-reactive protein, and interleukin-6 will be measured at 6, 24, and 48 hours following first administration of study drug.|48 hours|Samples were collected but not analyzed due to study termination. This study was terminated because the therapy was proven effective by larger studies.||||||
2554208|NCT02762084|Other Pre-specified|Percentage of Treatment-targeted SEBs Achieving Clear or Almost Clear on the 5-point Investigator Static Global Tumor Assessment (ISGTA) Scale|The ISGTA is a scale with scores ranging from 0 (clear), 1 (almost clear), 2 (minimal residual tumor), to 3 (clearly visible tumor). The Investigator assessed each Baseline treatment-targeted SEB at Weeks 6, 10, 14, 18, 22, and 26. SEBs were defined as clinically diagnosed BCC 5 mm or greater in diameter on the face, excluding the nose and periorbital skin, and 9 mm or greater at sites other than the face. The percentage of Baseline treatment-targeted SEBs evaluated as being clear or almost clear at Week x (Week x = Week 6, 10, 14, 18, 22 or 26) based on the ISGTA scale was calculated as follows: (Number of baseline treatment-targeted SEBs with ISGTA score of 0 or 1 at Week x) / (Number of Baseline treatment-targeted SEBs) * 100. Missing data were imputed using LOCF. The percentage of responders achieving clear (0) or almost clear (1) on the ISGTA scale are presented by Week.|Baseline and Weeks 6, 10, 14, 18, 22, and 26|Participants who received at least 1 dose of study drug.|||percentage of SEBs|||Number
2554209|NCT02762084|Secondary|Proportion of Treatment-Targeted SEBs No Longer Classified as SEBs After 26 Weeks|"SEBs were defined as clinically diagnosed BCC 5 mm or greater in diameter on the face, excluding the nose and periorbital skin, and 9 mm or greater at sites other than the face. The proportion of Baseline treatment-targeted SEBs that at the end of 26 weeks of treatment were no longer large enough to be classified as SEBs (that is, the proportion of Baseline treatment targeted SEBs on the face that became < 5 mm in greatest diameter and non-facial Baseline treatment targeted SEBs that became < 9 mm in greatest diameter) were calculated for each participant as follows:~(Number of Baseline treatment-targeted facial SEBs with greatest diameter < 5 mm) + (Baseline treatment targeted non-facial SEBs with greatest diameter < 9 mm) / Number of baseline treatment targeted SEBs.~Missing values were imputed using LOCF."|Baseline and Weeks 6, 10, 14, 18, 22, and 26|Participants who received at least 1 dose of study drug.|||proportion of SEBs||Standard Deviation|Mean
2554210|NCT02762084|Secondary|Proportion of Non-central Facial BCCs Increasing to ≥ 5 mm From Baseline|The proportion of non-central facial BCCs that at Baseline measured a greatest diameter of < 5 mm and increased to a diameter of ≥ 5 mm by Week x (Week x = Weeks 6, 10, 14, 18, 22, or 26) were calculated for each participant as follows: (Number of non−central facial BCCs with greatest diameter ≥ 5 mm at Week x) / (Number of non−central facial BCCs with greatest diameter < 5 mm at Baseline). Missing values were imputed using LOCF.|Baseline and Weeks 6, 10, 14, 18, 22, and 26|Participants who received at least 1 dose of study drug with non-central facial BCCs < 5 mm at Baseline.|||proportion of BCCs||Standard Deviation|Mean
2554211|NCT02762084|Secondary|Percent Change in Central Facial SEBs From Baseline|Central facial SEBs were defined as those located on the nose or periorbital area (eyelids) which were 3 mm or greater at Baseline. The percent change from Baseline to Week x (Week x = Weeks 6, 10, 14, 18, 22, or 26) in central facial SEBs was calculated as follows: [sum (Baseline) - sum (Week x)] / [sum (Baseline)] * 100 where sum = the greatest diameters of Baseline treatment-targeted SEBs where positive numbers to represent decrease in tumor size and negative numbers to represent increase in tumor size. Missing values were imputed using LOCF.|Baseline and Weeks 6, 10, 14, 18, 22, and 26|Participants who received at least 1 dose of study drug and who had a central facial SEB at Baseline.|||percent change||Standard Deviation|Mean
2554320|NCT02760264|Secondary|Serum Pharmacodynamic Biomarkers (Bone Turnover)-Type I Collagen C-Telopeptides|Pharmacodynamic biomarkers were measured to investigate the effects of single and multiple oral doses of vamorolone on serum PD biomarkers in ambulant boys ages 4-< 7 years with DMD.|Baseline, Day 1, Week 4|Safety Population: All subjects who receive at least one dose of vamorolone study medication will be included in the Safety Population.|||% change from Baseline||Standard Deviation|Mean
2554212|NCT02762084|Secondary|Percent Change in Baseline Treatment-targeted SEBs Tumor Size From Baseline|SEBs were defined as clinically diagnosed BCC 5 mm or greater in diameter on the face, excluding the nose and periorbital skin, and 9 mm or greater at sites other than the face. The percent change in greatest diameters of Baseline treatment-targeted SEBs from Baseline to Week x (Week 6, 10, 14, 18, or 22) was calculated as follows: (sum [Baseline] - sum [Week x] / sum [Baseline] * 100), where sum = the greatest diameters of Baseline treatment-targeted SEBs, and positive numbers to represent decrease in tumor size and negative numbers to represent increase in tumor size. Missing values were imputed using LOCF.|Baseline and Weeks 6, 10, 14, 18, and 22|Participants who received at least 1 dose of study drug.|||percentage change||Standard Deviation|Mean
2554213|NCT02762084|Secondary|The Mean Number of New SEBs on the Face for the Combined Patidegib Treatment Groups by Tumor Population|Facial SEBs were defined as clinically diagnosed BCC 5 mm or greater in diameter on the face, excluding the nose and periorbital skin. New facial SEBs are defined as those located at a site where there was no visible BCC of any size at Baseline. New facial SEBs were investigated for participants on vehicle gel versus participants on patidegib 2% and 4% gel. Missing values were imputed using LOCF. The mean number of new SEBs (number per participant) are presented. No measure of dispersion/precision was calculated.|Baseline, Week 26|By tumor per protocol population includes all treatment-targeted tumors except tumors that were biopsied and excludes tumors that did not meet protocol criteria.|||new SEBs||Standard Deviation|Mean
2554214|NCT02762084|Secondary|The Mean Number of New SEBs on the Face for the Combined Patidegib Treatment Groups|Facial SEBs were defined as clinically diagnosed BCC 5 mm or greater in diameter on the face, excluding the nose and periorbital skin. New facial SEBs are defined as those located at a site where there was no visible BCC of any size at Baseline. New facial SEBs were investigated for participants on vehicle gel versus participants on patidegib 2% and 4% gel. Missing values were imputed using LOCF. The mean number of new SEBs (number per participant) are presented. No measure of dispersion/precision was calculated.|Baseline, Week 26|Participants who received at least 1 dose of study drug.|||new SEBs||Standard Deviation|Mean
2554215|NCT02762084|Secondary|The Number of Participants Reporting New SEBs on the Face From Baseline for the Combined Patidegib Treatment Groups|Facial SEBs were defined as clinically diagnosed BCC 5 mm or greater in diameter on the face, excluding the nose and periorbital skin. New facial SEBs are defined as those located at a site where there was no visible BCC of any size at Baseline. New facial SEBs were investigated for participants on vehicle gel versus participants on patidegib 2% and 4% gel. Missing values were imputed using LOCF.|Baseline, Week 26|Participants who received at least 1 dose of study drug.|||participants|||Number
2554216|NCT02762084|Primary|Safety and Tolerability Assessment of Treatment With Patidegib Gel: Number of Participants With Treatment-emergent Administrative Site Skin Condition AEs Causally Related to Study Drug.|All SAEs and all other non-serious AEs, regardless of causality, are located in the Reported AE Module. The number of participants reporting administrative-site, skin condition treatment-emergent AEs considered related to study drug by the Investigator are presented below. Treatment-emergent AEs are those with an onset after use of study drug.|Baseline through Week 26|All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.|||participants|||Number
2554217|NCT02762084|Primary|Safety and Tolerability Assessment of Treatment With Patidegib Gel: Number of Treatment-emergent Adverse Events Causally Related to Study Drug.|All serious adverse events (SAEs) and all other non-serious adverse events (AEs) regardless of causality are located in the Reported AE Module. The number of AEs considered related to study drug by the Investigator are presented below. Treatment-emergent AEs are those with an onset after use of study drug.|Baseline through Week 26|All enrolled participants who were randomized, received at least 1 confirmed dose of study drug, and had at least 1 post-baseline safety assessment.|||events|||Number
2554218|NCT02762084|Primary|Molecular Efficacy: Percent Change in the Hedgehog (HH) Signaling Pathway Target Gene Glioma-associated Oncogene Homolog 1 (GLI1) Messenger Ribonucleic Acid (mRNA) Levels From Baseline|SEBs were defined as clinically diagnosed BCC 5 mm or greater in diameter on the face, excluding the nose and periorbital skin, and 9-mm or greater at sites other than the face. A single baseline SEB designated as a treatment targeted tumor at Baseline was biopsied first at Baseline and again following 6 weeks of treatment. This was used to assess percent change in GLI1 mRNA levels as follows: (Baseline - Week 6) / Baseline * 100, where positive numbers to represent decrease in GL1 mRNA level and negative numbers to represent increase in GL1 mRNA level. Any missing values were not imputed; all available data is summarized.|Baseline, Week 6|Participants who received at least 1 dose of study drug who had evaluable GLI1 mRNA data at Baseline and Week 6.|||percentage change||Standard Deviation|Mean
2554219|NCT02762084|Primary|Clinical Efficacy: Percent Change in Tumor Size of Treatment-targeted Surgically Eligible Basal Cell Carcinomas (SEBs) From Baseline|SEBs were defined as clinically diagnosed basal cell carcinoma (BCC) 5 millimeters (mm) or greater in diameter on the face, excluding the nose and periorbital skin, and 9 mm or greater at sites other than the face. The percent change in greatest diameters of treatment-targeted surgically eligible basal cell carcinomas (SEBs) from Baseline to Week 26 was calculated as follows: (sum [Baseline] - sum [Week 26] / sum [Baseline] * 100), where sum = the greatest diameters of Baseline treatment-targeted SEBs and positive numbers represent decrease in tumor size and negative numbers to represent increase in tumor size. Missing values were imputed using Last-Observation Carried Forward (LOCF).|Baseline, Week 26|By tumor per protocol population includes all treatment-targeted tumors except tumors that were biopsied and excludes tumors that did not meet protocol criteria.|||percentage change|Number of tumors|Standard Deviation|Mean
2554220|NCT02762071|Secondary|Length of Stay in the Post-anesthesia Care Unit (PACU)|Duration of stay in the post-anesthesia care unit (minutes) after shoulder replacement surgery.|At the time of discharge from PACU, Up to 1 day||||minutes||Standard Deviation|Mean
2554221|NCT02762071|Secondary|Patient Satisfaction With Pain Management|Visual Analog Scale (VAS) score for satisfaction with pain control in the hospital and at home. This was assessed at subjects' first postoperative visit.VAS satisfaction scores range from 0 (not satisfied) to 10 (completely satisfied).|At first postoperative visit, up to 30 days||||score on a scale||Standard Deviation|Mean
2554222|NCT02762071|Secondary|Postoperative Visual Analog Scale (VAS) Pain Scores|We analyzed postoperative VAS pain scores at 6, 12, 18, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 hours and at the first postoperative visit. VAS pain scores range from 0 (no pain) to 10 (unbearable pain).|Up to first postoperative visit, maximum 30 days||||score on a scale||Standard Deviation|Mean
2554226|NCT02761980|Other Pre-specified|Number of Participants With Treatment Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 24 hours after discharge (up to 32 hours) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline up to 24 hours after discharge (up to 32 hours)|Safety analysis set included all participants who received study medication.|||Participants|||Count of Participants
2554227|NCT02761980|Secondary|Time Weighted Sum of Temperature Difference From 6 to 8 Hours|WSTD 6-8 was defined as time-weighted sum of temperature differences between 6 to 8 hours post-dose, weighted by time elapsed between each 2 consecutive time points within 6 to 8 hours (6.5, 7, 7.5 and 8 hours). Temperature difference was defined as temperature at 6 hours minus the temperature at specified time points (6.5, 7, 7.5 and 8 hours).|6 to 8 hours postdose|"mITT population included all randomized participants who were dosed with the study medication and RSE per procedures specified in protocol post amendment 4 and had a baseline assessment. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||degrees fahrenheit||Standard Deviation|Mean
2554228|NCT02761980|Secondary|Time to Rescue Medication|Time to rescue medication (other than study treatment) (in minutes) was defined as time from first dosing of study medication to the time a participant first takes a rescue medication, or to the end of the study time for participants that do not take any rescue medication prior to the end of the study. The rescue medication was defined as medication received for the treatment of fever during the time period from the administration of study medication to the time of end of the study.|0 to 8 hours post dose|"mITT population included all randomized participants who were dosed with the study medication and RSE per procedures specified in protocol post amendment 4 and had a baseline assessment. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||minutes||95% Confidence Interval|Median
2554229|NCT02761980|Secondary|Time to Return to Normal Body Temperature|Time to return to normal body temperature was defined as time from initial measurement of normal body temperature (at baseline; before administration of first test dose of RSE to induce pyrexia) till the time at which normal temperature was achieved again after pyrexia. Normal body temperature was defined as the last non-missing body temperature value, assessed prior to or at the time of first RSE test dose.|Baseline (pre-dose) up to 8 hours post dose|"mITT population included all randomized participants who were dosed with the study medication and RSE per procedures specified in protocol post amendment 4 and had a baseline assessment. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||minutes||95% Confidence Interval|Median
2554230|NCT02761980|Secondary|Time Weighted Sum of Temperature Differences (WSTD) From Baseline Through Hours 2, 4 and 6|WSTD 0-2, 0-4 and 0-6 was defined as time-weighted sum of temperature differences over each specified time interval (0-2 hour, 0-4 hour and 0-6 hour), weighted by time elapsed between each 2 consecutive time points post treatment (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour), within each time interval. Temperature difference was defined as baseline temperature (at 0 hour) minus the post-baseline temperature at each time point within each specified time interval: 1) 0-2 hour (20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes) , 2) 0-4 hour (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4 hour), 3) 0-6 hour (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6 hour).|0 to 2 hours postdose, 0 to 4 hours postdose, 0 to 6 hours postdose|"mITT population included all randomized participants who were dosed with the study medication and RSE per procedures specified in protocol post amendment 4 and had a baseline assessment. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||degrees fahrenheit||Standard Deviation|Mean
2554231|NCT02761980|Primary|Time Weighted Sum of Temperature Difference (WSTD) From 0 to 8 Hours|WSTD 0-8 was defined as time-weighted sum of temperature differences over 8 hours, weighted by time elapsed between each 2 consecutive time points post treatment (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours). Temperature difference was defined as baseline temperature (at 0 hour) minus the post-baseline temperature at each time point up to 8 hours (10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110 minutes, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5 and 8 hours).|0 to 8 hours post-dose|"Modified intent to treat (mITT) population included all randomized participants who were dosed with the study medication and RSE per procedures specified in protocol post amendment 4 and had a baseline assessment. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||degrees fahrenheit||Standard Deviation|Mean
2554232|NCT02761967|Secondary|Sleep Quality in Pregnant; Pittsburgh Sleep Quality Index (PSQI)|"Assess the quality of sleep of pregnant women with moderate activity in water, with respect to who do not practice.~Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.The order of the PSQI items has been modified from the original order in order to fit the first 9 items (which are the only items that contribute to the total score) on a single page. Item 10, which is the second page of the scale, does not contribute to the PSQI score.~In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality."|Twelve month|During the data collection, 3 women from the control group were lost because they did not complete the PSQI questionnaire during the follow-up phase. The analysis excluded 3 women from the intervention group due to errors at the time of completing the PSQI questionnaire.|||units on a scale||Standard Deviation|Mean
2554251|NCT02761629|Secondary|Change From Baseline in Cluster of Differentiation (CD) 4 (CD4) Cell Counts at Weeks 4, 12, 24, 48, 72, and 96|Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).|"For Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks arm: Baseline, Weeks 4, 12, 24, 48, and 72; for Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96"|"ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable at specified time-point; for each arm, respectively."|||Cells per cubic millimeter (cells/mm^3)||Standard Deviation|Mean
2554233|NCT02761967|Primary|Edinburgh Postnatal Depression Scale|"Determine the rate of postpartum depression in both groups. The scale consists of ten short questions, all of which must be answered. The subject is asked to choose, of the four possible answers, the one that most closely describes how she felt during the week prior to the test. The response options range from 0 (for example, no, not at all or no, never again) to 3 (for example, yes, most of the time or yes, very often). The total score is recorded in a table ranging from 0 to 30, where higher values indicate more severe symptoms of depression.~For this study, total scores below 10 were classed as no risk and scores of 10 or more indicated the presence of risk. Scores above 16 indicated a more severe risk of depression, and suggested that additional evaluations should be conducted immediately."|Six month||||units on a scale||Standard Deviation|Mean
2554234|NCT02761967|Primary|Delivery Times Measured in Partogram|This result is to measure the difference in time between births to women who have made physical exercise during pregnancy, SWEP method, compared to women who have not exercised .|Twenty four month|The total duration of delivery times between women in the control group and women in the exercise group will be compared.|||minutes||Standard Deviation|Mean
2554235|NCT02761733|Primary|Communication Satisfaction Questionnaire|"Communication satisfaction was measured utilizing a modified version of a 19-item measure of communication patterns between physicians and their clients (Campbell et al., 2007). Thirteen items focusing on the client's satisfaction with communication with their provider and their engagement in treatment were measured on a 7-point scale (strongly agree, agree, agree somewhat, undecided, disagree somewhat, disagree, strongly disagree). Example items included My provider checks to be sure that I understand everything or My provider involves me in decisions as much as I want. Total average scores range from 1 to 7 with higher scores indicating better communication satisfaction. Analyses will examine change in Satisfaction Questionnaire scores from pre- to post-intervention."|Change in scores on the Communication Satisfaction Questionnaire from Baseline to 24 month follow-up|Several factors influenced variability in the number of participants analyzed across time points. First, patients may have responded to some items but opted out of others because of questionnaire length or comprehension considerations. Second, some patients were available at baseline but were unavailable at subsequent time points, or vice versa.|||units on a scale||Standard Deviation|Mean
2554236|NCT02761733|Primary|Working Alliance Inventory|"The Working Alliance Inventory measures the perception of therapeutic alliance in a clinical dyad during the process of developing a relationship required for effective psychotherapy. The current study utilized the client version of the Working Alliance Inventory included 7 items measured on a 7-point scale (never, rarely, occasionally, sometimes, often, very often, always). Example items included I am confident in my provider's ability to help me and My provider and I trust one another. The Working Alliance Inventory total average score ranges from 1 to 7, with high scores indicating a more positive outcome. Analyses will examine change in patient-reported Working Alliance Inventory scores from pre- to post-intervention."|Change in scores on the Working Alliance Inventory from Baseline to 24 month follow-up|Several factors influenced variability in the number of participants analyzed across time points. First, patients may have responded to some items but opted out of others because of questionnaire length or comprehension considerations. Second, some patients were available at baseline but were unavailable at subsequent time points, or vice versa.|||units on a scale||Standard Deviation|Mean
2554237|NCT02761733|Primary|Shared Decision Making Questionnaire|"A 6-item modified version of the Shared Decision Making Questionnaire (SDM-Q-9) 46 was utilized to assess client reports about the degree to which their provider involved them in understanding and making a treatment decision. Examples items included My provider discussed the advantages and disadvantages of options and strategies or My provider helped me understand all the information measured on a 6-point scale (completely disagree, strongly disagree, somewhat disagree, somewhat agree, strongly agree, and completely agree). The total average score ranges from 1 to 6 with higher scores indicating a better outcome of greater shared decision making. Analyses will examine change in Shared Decision Making Questionnaire scores from pre- to post-intervention."|Change in scores on the Shared Decision Making Questionnaire from Baseline to 24 month follow-up|Several factors influenced variability in the number of participants analyzed across time points. First, patients may have responded to some items but opted out of others because of questionnaire length or comprehension considerations. Second, some patients were available at baseline but were unavailable at subsequent time points, or vice versa.|||units on a scale||Standard Deviation|Mean
2554238|NCT02761733|Primary|Outcome Rating Scale (ORS)|The Outcome Rating Scale (ORS) was utilized as a repeated measure of general therapy outcomes and quality of life changes during the course of therapy. The Outcome Rating Scale includes a visual analog scale (a horizontal line on which the participants marks how well they are doing within the last week from low to high) that records four questions about general well-being, personal well-being, close relationships, and work/school/friend relationships. Physical marks for each of four domains on the visual analog scale are measured by research team members with a ruler and converted to a score from 1 to 100. The four items are then averaged for an overall therapy outcome score. The total averaged ORS score ranges from 1 to 100, with higher scores indicating a better outcome. Analyses will examine treatment progress via change in ORS scores from pre- to post-intervention.|Change in scores on the Outcome Rating Scale from Baseline to 24 month follow-up|Several factors influenced variability in the number of participants analyzed across time points. First, patients may have responded to some items but opted out of others because of questionnaire length or comprehension considerations. Second, some patients were available at baseline but were unavailable at subsequent time points, or vice versa.|||units on a scale||Standard Deviation|Mean
2554249|NCT02761629|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Level Categories|ALT levels were classified as: Normal Limit (NL) (as per laboratory standard), >1-2 Upper Normal Limit (ULN), >2-5 ULN, >5-10 ULN, and >10 ULN. Percentage of participants in each of these ALT level categories was reported. Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).|"For Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks arm: Weeks 4, 12, 24, 48, and 72; for Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks arm: Weeks 4, 12, 24, 48, 72, and 96"|Safety analysis population: all randomized participants who receive >/=1 dose of any study medication and had >/=1 post-baseline safety assessment. Number of participants analyzed= overall participants who were evaluable for this outcome at any time-point and “n” = participants who were evaluable at specified time-point; for each arm, respectively.|||percentage of participants|||Number
2554239|NCT02761733|Primary|Short Form Health Survey-12 (SF-12) Mental Symptoms|The mental health subscale (MCS-12; Mental Component Summary) of the SF-12 (Health Survey Short Form-12) was utilized in the current study to assess mental aspects of health and well-being48. The measure includes twelve questions asking about overall health, limitations from health conditions, physical health, emotional well-being and daily activities, and feelings over the past four weeks, utilizing variable Likert scale response choice options. The physical health subscale of the SF-12 was utilized as a key client functioning outcome in the current study. The aggregate MCS subscale score of the SF-12 is calculated utilizing norm-based scoring with a weighted sum (Ware, Kosinski, & Keller, 1995). MCS scores in the present study ranged from 9.6 to 72.0, with higher values indicating better physical health.|Change in scores on the SF-12 from Baseline to 24 month follow-up Description: The Health Survey Short Form-12 (SF-12) includes 12 items that assess for physical and mental aspects of health and well-being.|Several factors influenced variability in the number of participants analyzed across time points. First, patients may have responded to some items but opted out of others because of questionnaire length or comprehension considerations. Second, some patients were available at baseline but were unavailable at subsequent time points, or vice versa.|||units on a scale||Standard Deviation|Mean
2554240|NCT02761733|Primary|Short Form Health Survey-12 (SF-12), Physical Symptoms Subscale|The physical health subscale (PCS-12; Physical Component Summary) of the SF-12 (Health Survey Short Form-12) was utilized in the current study to assess physical aspects of health and well-being48. The measure includes twelve questions asking about overall health, limitations from health conditions, physical health, emotional well-being and daily activities, and feelings over the past four weeks, utilizing variable Likert scale response choice options. The aggregate PCS subscale score of the SF-12 is calculated utilizing norm-based scoring with a weighted sum (Ware, Kosinski, & Keller, 1995). PCS scores in the present study ranged from 13.2 to 65.6, with higher values indicating better physical health.|Change in scores on the SF-12 from Baseline to 24 month follow-up|Several factors influenced variability in the number of participants analyzed across time points. First, patients may have responded to some items but opted out of others because of questionnaire length or comprehension considerations. Second, some patients were available at baseline but were unavailable at subsequent time points, or vice versa.|||units on a scale||Standard Deviation|Mean
2554241|NCT02761642|Secondary|Quality of Life Assessment Using Functional Assessment of Cancer Therapy-Anemia (FACT-An) Questionnaire Scores|FACT-An comprised of 2 subscales ('Fatigue' and 'Non-fatigue') of 20-items. All questions were rated on a scale from 0 to 4, where higher scores indicate improved quality of life. The 'Fatigue' subscale consists of 13 questions with score range from 0-52; 'Non-fatigue' subscale consists of 7 questions with score range from 0-28. Total FACT-An score was transformed to a 0-100 scale (instead of 0-80 scale) to get better perception of the participant's quality of life indicator.|Baseline, Week 12|"Safety population. Here, “Number of Participants Analyzed” represents number of participants evaluable for this outcome measure and Number Analyzed represents number of participants evaluable at specified time points."|||units on a scale||95% Confidence Interval|Mean
2554242|NCT02761642|Secondary|Mean Time Needed to Increase Hemoglobin Level by At Least 1 g/dL|Time to increase in hemoglobin level by at least 1 g/dL was defined as the time between the start of treatment and an increase in hemoglobin level by at least 1 g/dL compared to baseline hemoglobin level. Time to response was estimated using Kaplan Meier method.|Baseline up to Week 12|Safety population|||days||95% Confidence Interval|Mean
2554243|NCT02761642|Secondary|Percentage of Participants With an Increase From Baseline in Hemoglobin Levels of At Least 1 g/dL After 4 Weeks||Baseline, Week 4|Safety population|||percentage of participants||95% Confidence Interval|Number
2554244|NCT02761642|Secondary|Overall Mean Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment||Baseline, Week 12|Safety population|||g/dL||95% Confidence Interval|Mean
2554245|NCT02761642|Secondary|Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Time Spent on Chemotherapy at Baseline|Participants were distributed into 2 subgroups. One subgroup contained participants who had spent <6 months on chemotherapy and other subgroup contained participants who had spent 6 months or more on chemotherapy.|Baseline, Week 12|"Safety population. Here, Number Analyzed represents number of participants evaluable for the specified category."|||g/dL||95% Confidence Interval|Mean
2554246|NCT02761642|Secondary|Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to Chemotherapy at Baseline|Participants were distributed into 3 subgroups. First subgroup contained participants who received adjuvant chemotherapy. Second subgroup contained participants who received metastatic 1st or 2nd line chemotherapy. Third subgroup contained participants who received metastatic 3rd line chemotherapy.|Baseline, Week 12|"Safety population. Here, Number Analyzed represents number of participants evaluable for the specified category."|||g/dL||95% Confidence Interval|Mean
2554247|NCT02761642|Secondary|Change From Baseline in Hemoglobin Levels After 12 Weeks of Study Treatment in Participants According to the Hemoglobin Level at Baseline|Participants were distributed into 2 subgroups. One subgroup contained participants who had hemoglobin (Hb) level less than (<) 10 g/dL and other subgroup contained participants who had hemoglobin level greater than or equal to (≥) 10 g/dL but <11 g/dL (10≤ Hb <11 g/dL).|Baseline, Week 12|"Safety population. Here, Number Analyzed represents number of participants evaluable for the specified category."|||g/dL||95% Confidence Interval|Mean
2554248|NCT02761642|Primary|Percentage of Participants With Response to Treatment Based on Hemoglobin Levels|Response was defined as increase of hemoglobin levels by at least 2 grams per deciliter (g/dL) as compared to baseline or the achievement of hemoglobin level of 12 g/dL after 12 weeks of treatment in the absence of red blood cells transfusion.|Week 12|Safety population|||percentage of participants||95% Confidence Interval|Number
2554250|NCT02761629|Secondary|Change From Baseline in CD4/CD8 Ratio at Weeks 4, 12, 24, 48, 72, and 96|Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).|"For Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks arm: Baseline, Weeks 4, 12, 24, 48, and 72; for Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks arm: Baseline, Weeks 4, 12, 24, 48, 72, and 96"|"ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable at specified time-point; for each arm, respectively."|||Ratio||Standard Deviation|Mean
2554252|NCT02761629|Secondary|Serum Human Immunodeficiency Virus (HIV) RNA Levels|HIV RNA levels were measured using Roche AMPLICOR MONITOR HIV-1 Test (limit of detection: 400 HIV-1 RNA copies/mL). Data for this outcome measure was to be reported up to 24 weeks after end of treatment visit (Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 96 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).|"For Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks arm: Weeks 4, 12, 24, 48, and 72; for Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks arm: Weeks 4, 12, 24, 48, 72, and 96"|"ITT analysis population. Here, number of participants analyzed = participants with detectable HIV RNA levels and n = participants with detectable HIV RNA levels at specified time-point; for each arm, respectively."|||Log10 copies per milliliter||Standard Deviation|Mean
2554253|NCT02761629|Secondary|Percentage of Participants Without SVR Among Participants With Undetectable HCV RNA at the End of Treatment|"SVR was defined as having undetectable HCV RNA levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Percentage of participants without SVR among participants with undetectable HCV RNA at the end of treatment was reported (end of treatment = Week 48 for Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks arm and Week 72 for Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks arm)."|"24 weeks after completion of study treatment (up to Week 72 for Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks arm and up to Week 96 for Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks arm)"|ITT analysis population. Here, number of participants analyzed signifies participants with undetectable HCV RNA at the end of treatment.|||percentage of participants|||Number
2554254|NCT02761629|Secondary|Percentage of Participants With Undetectable HCV RNA 12 Weeks After the Last Dose of Peg-IFN-Alpha-2A|HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Participants with detectable HCV RNA or without measurement at the end of 12 weeks after the last dose of Peg-IFN-Alpha-2A were considered as non-responders.|"12 weeks after the last dose of Peg-IFN-Alpha-2A (up to Week 60 for Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks arm and up to Week 84 for Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks arm)"|ITT analysis population|||percentage of participants||95% Confidence Interval|Number
2554255|NCT02761629|Secondary|Percentage of Participants With Undetectable HCV RNA|HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 IU/mL). Data for this outcome measure was to be reported up to end of treatment visit (Week 48 for 'Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks' arm and Week 72 for 'Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks' arm).|"For Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks arm: Weeks 4, 12, 24, and 48; for Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks arm: Weeks 4, 12, 24, 48, and 72"|"ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for this outcome at specified time-point; for each arm, respectively."|||percentage of participants||95% Confidence Interval|Number
2554256|NCT02761629|Primary|Percentage of Participants With Sustained Virologic Response (SVR)|SVR was defined as having un-detectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 24 weeks after completion of study treatment. HCV RNA levels were measured using Roche COBAS AMPLICOR HCV Test (limit of detection: 50 International Units per milliliter [IU/mL]). Participants with detectable HCV RNA or without measurement at the end of the 24 week after completion of study treatment were considered as non-responders.|"24 weeks after completion of study treatment (up to Week 72 for Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks arm and up to Week 96 for Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks arm)"|Intent-to-treat (ITT) analysis population|||percentage of participants||95% Confidence Interval|Number
2554257|NCT02761252|Secondary|Usage of Relief Medication for Asthma|Number of days without any relief medication for Asthma.|From baseline to 4 weeks of treatment|"The Intention To Treat population (used for statistical analysis) was 419 patients because 1 patient in Montekukast Monotherapy arm was a drop-out.~The drop-out patient was, instead, included in a Safety Population (420 patients)."|||Days||Standard Error|Least Squares Mean
2554258|NCT02761252|Secondary|Usage of Relief Medication for SARC|Number of days without any relief medication for SARC|From baseline to 4 weeks of treatment|"The Intention To Treat population (used for statistical analysis) was 419 patients because 1 patient in Montekukast Monotherapy arm was a drop-out.~The drop-out patient was, instead, included in a Safety Population (420 patients)."|||Days||Standard Error|Least Squares Mean
2554259|NCT02761252|Secondary|Change From Baseline With Montelukast + Bilastine Compared With Montelukast and Bilastine Monotherapies in SARC Symptoms (DNNSS)|"To evaluate the efficacy of concomitant montelukast and bilastine compared with montelukast and bilastine monotherapies in daytime symptoms of SARC, as assessed by Daytime Non Nasal Symptom Score (DNNSS) after 4 weeks of treatment.~Daytime Non Nasal Symptom Score (DNSS) is the average of individual scores of ocular redness, ocular itching and tearing of rhinoconjuctivits.~Each of the 3 symptoms is scored from 0 (absent) to 3 (severe) as follows:~0 (absent) Symptom not present~1 (mild) Symptom is clearly present but easily tolerated, a nuisance, minimal awareness~2 (moderate) Symptom is bothersome but tolerable, does not interfere with daily activities or sleep~3 (severe) Symptom is hard to tolerate and interferes with daily activities or sleep.~DNNSS assessment comprises of scoring (0-3) of all 3 above mentioned symptoms. Final DNNSS scores is in a range from 0-9."|After 4 weeks of treatment (from baseline)|"The Intention To Treat population (used for statistical analysis) was 419 patients because 1 patient in Montekukast Monotherapy arm was a drop-out.~The drop-out patient was, instead, included in a Safety Population (420 patients)."|||score on a scale||95% Confidence Interval|Mean
2554260|NCT02761252|Secondary|Change From Baseline With Montelukast+Bilastine Compared With Montelukast and Bilastine Monotherapies in SARC Symptoms (DNSS)|"To evaluate the efficacy of concomitant montelukast and bilastine compared with montelukast and bilastine monotherapies in daytime symptoms of SARC, as assessed by Daytime Nasal Symptom Score (DNSS) after 4 weeks of treatment.~Daytime Nasal Symptom Score (DNSS) is the average of individual scores of nasal congestion, rhinorrhea, nasal itching, sneezing of rhinoconjuctivits.~Each of the 4 symptoms is scored from 0 (absent) to 3 (severe) as follows:~0 (absent) Symptom not present~1 (mild) Symptom is clearly present but easily tolerated, a nuisance, minimal awareness~2 (moderate) Symptom is bothersome but tolerable, does not interfere with daily activities or sleep~3 (severe) Symptom is hard to tolerate and interferes with daily activities or sleep.~DNSS assessment comprises of scoring (0-3) of all 4 above mentioned symptoms. Final DNSS scores is in a range from 0-12."|After 4 weeks of treatment (from baseline)|"The Intention To Treat population (used for statistical analysis) was 419 patients because 1 patient in Montekukast Monotherapy arm was a drop-out.~The drop-out patient was, instead, included in a Safety Population (420 patients)."|||score on a scale||95% Confidence Interval|Mean
2554261|NCT02761252|Secondary|Change From Baseline With Montelukast+Bilastine Compared With Montelukast and Bilastine Monotherapies in Asthma Control|"To evaluate the efficacy of concomitant montelukast and bilastine compared with montelukast and bilastine monotherapies in asthma control, as assessed by Asthma Quality of Life Questionnaire (AQLQ) after 4 weeks.~The AQLQ was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma.~Each of the 32 questionnaire's items will be scored on a 7-point scale (where 7 means not impaired at all and 1 means severely impaired). The overall AQLQ score is the mean of all 32 responses (https://www.qoltech.co.uk/aqlq.html).~The change in AQLQ score from baseline to 4 weeks after treatment - AQLQ score at baseline for patients with both available values has been the secondary endpoint."|After 4 weeks of treatments|"The Intention To Treat population (used for statistical analysis) was 419 patients because 1 patient in Montekukast Monotherapy arm was a drop-out.~The drop-out patient was, instead, included in a Safety Population (420 patients)."|||score on a scale||95% Confidence Interval|Mean
2554262|NCT02761252|Primary|Change From Baseline With Montelukast+Bilastine Compared With Bilastine Monotherapy in SARC Symptoms|"To demonstrate that concomitant administration of montelukast and bilastine is superior to bilastine monotherapy in SARC symptoms, as assessed by Total Symptoms Scores (TSS) after 4 weeks of treatment.~Total Symptoms Scores (TSS) assesses nasal (nasal congestion, rhinorrhea, nasal itching, sneezing) and non nasal symptoms (ocular redness, ocular itching, tearing) of rhinoconjuctivits.~Each of the 7 symptoms is scored from 0 (absent) to 3 (severe) as follows:~0 (absent) Symptom not present~1 (mild) Symptom is clearly present but easily tolerated, a nuisance, minimal awareness~2 (moderate) Symptom is bothersome but tolerable, does not interfere with daily activities or sleep~3 (severe) Symptom is hard to tolerate and interferes with daily activities or sleep.~TSS assessment comprises of scoring (0-3) of all 7 above mentioned symptoms. Final TSS scores is in a range from 0-21."|4 weeks of treatment (from baseline to 4 weeks of treatment)||||score on a scale||95% Confidence Interval|Mean
2554263|NCT02760927|Primary|Proportion of Participants on Which the Test Product Allowed for Effective Subglottic Suctioning|Assessed by the proportion of yes/no researcher responses|Typical wear time of endotracheal tube fastener up to one week|Intent-to-Treat|||Participants|||Count of Participants
2554264|NCT02760927|Primary|Proportion of Participants on Which the Test Product Protected the Subglottic Suction Lumen|Assessed by the proportion of yes/no researcher responses|Typical wear time of endotracheal tube fastener up to one week|Intent-to-Treat|||Participants|||Count of Participants
2554265|NCT02760927|Primary|Proportion of Participants on Which the Test Product Allowed the Subglottic Suction Lumen to Remain Within the Subglottic Suction Lumen Tract|Assessed by the proportion of yes/no researcher responses|Typical wear time of endotracheal tube fastener up to one week|Intent-to-Treat|||Participants|||Count of Participants
2554266|NCT02760927|Primary|Proportion of Participants on Which the Subglottic Suction Lumen Was Easy to Place Into the Tract With the Tube Protection Sleeve|Assessed by the proportion of researcher responses that equal agree (4) plus strongly agree (5) on a five point scale that includes strongly disagree (1) disagree (2) and no opinion (3)|Typical wear time of endotracheal tube fastener up to one week|Intent-to-Treat|||Participants|||Count of Participants
2554267|NCT02760927|Primary|Proportion of Participants on Which Test Product Allowed for Proper Placement of the Subglottic Suction Lumen|Assessed by the proportion of yes/no researcher responses|Typical wear time of endotracheal tube fastener up to one week|Intent-to-Treat|||Participants|||Count of Participants
2554268|NCT02760810|Secondary|Tear Film PH|Tear Film PH was measured using a 1mm Microglass electrode (Thermo Scientific Orion 9810BN) placed gently in lower temporal tear meniscus of non-Schirmer eye without simulating reflex tearing.|1-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||PH value||Standard Deviation|Mean
2554269|NCT02760810|Secondary|Tear Film Osmolarity|Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing.|1-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||mOsm/L|Eyes|Standard Deviation|Mean
2554270|NCT02760810|Primary|Tear Film Osmolarity|Tear film osmolarity was measured in each subject eye using the TearLab Osmolarity system. The instrument was placed gently into the lower lid temporal tear minuscus without simulating reflex tearing|2-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||mOsm/L|Eyes|Standard Deviation|Mean
2554271|NCT02760654|Secondary|Change in PROMIS Pain Interference 4a Scores at 8 Weeks|The PROMIS Pain Interference 4a is scored on a scale of 41.6 to 75.6, with a score of 41.6 meaning little or no interference with daily activities due to pain severity, and a score of 75.6 meaning a high degree of interference with daily activities due to pain severity.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.|||units on a scale||Standard Deviation|Mean
2554272|NCT02760654|Secondary|Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale Scores at 8 Weeks|The European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy contains three subscales: Sensory, Motor, and Autonomic. Each subscale is scored on a scale of 0 - 100, with a score of 0 representing no neuropathy symptoms and functional impairment due to neuropathy, and a score of 100 represents severe neuropathy symptoms and functional impairment due to neuropathy. Only the Sensory and Motor subscales were used in this current study.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.|||units on a scale||Standard Deviation|Mean
2554288|NCT02760602|Secondary|Change From Baseline on the Resource Utilization in Dementia-Lite (RUD-Lite)|RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD). Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
2554273|NCT02760654|Secondary|Adapted Acceptability E-Scale|The Adapted Acceptability E- Scale contains 7 items that are scored on a 1 - 5 scale, with a score of 1 representing low ratings of acceptability and satisfaction with the online self management program, and a score of 5 representing high ratings of acceptability and satisfaction with the online self management program. This measure was only administered to individuals participating in the online self management program.|8 week|Only 19 in the people in the online self-management group of the 23 that completed the study actually completed the information for this measure. Thus only 19 are analyzed. No participants in the control group were administered this measure because the questions pertained to the acceptability and satisfaction of the online self management program.|||units on a scale||Standard Deviation|Mean
2554274|NCT02760654|Secondary|Change in 0 - 10 Average Pain Intensity Numerical Rating Scale Scores at 8 Weeks|The 0 - 10 Average Pain Intensity Numerical Rating Scale was scored on a scale of 0 - 10, with a score of 0 meaning no pain, and a score of 10 meaning worst pain imaginable.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.|||units on a scale||Standard Deviation|Mean
2554275|NCT02760654|Secondary|Patient Global Impression of Change|The Patient Global Impression of Change is scored on a scale of 1 - 7, with a score of 1 representing that the patient was very much worse following the trial, and a score of 7 representing that the patient was very much improved following the course of the trial.|8 week|Only 19 in the people in the online self-management group and 22 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 22 respectively are analyzed.|||Participants|||Count of Participants
2554276|NCT02760654|Secondary|Change in PROMIS Short Form Sleep-Related Impairment 8a Scores at 8 Weeks|The PROMIS Short Form Sleep-Related Impairment 8a is scored on a scale of 30.0 to 80.1 with a score of 30.0 meaning no sleep-related impairment and a score of 80.1 meaning a high degree of impairment in daily activities due to poor sleep.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.|||units on a scale||Standard Deviation|Mean
2554277|NCT02760654|Secondary|Change in PROMIS Short Form Fatigue 4a Scores at 8 Weeks|The PROMIS Short Form Fatigue 4a is scored on a scale of 33.7 to 75.8, with a score of 33.7 meaning no fatigue and a score of 75.8 meaning high fatigue.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.|||units on a scale||Standard Deviation|Mean
2554278|NCT02760654|Secondary|PROMIS Short Form Anxiety 4a|The PROMIS Short Form Anxiety 4a is scored on a scale of 40.3 - 81.6, with a score of 40.3 meaning no anxiety and a score of 81.6 meaning high anxiety.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.|||units on a scale||Standard Deviation|Mean
2554279|NCT02760654|Secondary|Change in PROMIS Short Form Emotional Distress - Depression 4a Scores at 8 Weeks|The PROMIS short form emotional distress depression 4a Scores are measured on a scale whose lowest possible score is 41.0 and highest is 79.4 where 41 is no emotional distress and 79.4 is extreme distress.|Baseline to 8 weeks|Only 19 in the people in the online self-management group and 23 in the Control group of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 and 23 respectively are analyzed.|||units on a scale||Standard Deviation|Mean
2554280|NCT02760654|Primary|Change in 0 - 10 Numerical Rating Scale of Worst Pain Intensity Scores at 8 Weeks|Pain is measured on the numerical rating scale of 0 - 10 where 0 is no pain and 10 is worst imaginable pain.|Baseline to 8 weeks|Only 19 people in each arm out of the 23 and 24 that completed the study actually completed the information for this measure. Thus only 19 are analyzed.|||units on a scale||Standard Deviation|Mean
2554281|NCT02760602|Secondary|Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET|Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
2554282|NCT02760602|Secondary|Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Aβ and CSF Tau Proteins|Changes in CSF parameters, including total and free Aβ1-40 and Aβ1-42 species and total tau and P-tau181 peptides, will be assessed.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
2554283|NCT02760602|Secondary|Change From Baseline in Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr)|Florbetapir F18 PET used to assess the treatment effect in brain amyloid plaque deposition from baseline through 18 months as measured by florbetapir F18 PET Standardized Uptake Uptake Value ratio.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
2554284|NCT02760602|Secondary|Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)|MRI will be used to assess the effect of treatment on rate of whole brain volume.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
2554285|NCT02760602|Secondary|Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab|Concentration of amino acid peptide known as Aβ 1-42 in plasma.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
2554286|NCT02760602|Secondary|Change From Baseline on the Quality of Life in Alzheimer's Disease Scale (QoL-AD)|QoL for AD assess participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items rated on a 4-point scale. Sum of items=total score (range: 13-52). Higher scores=greater QoL.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
2554287|NCT02760602|Secondary|Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D)|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Visual analogue scale (VAS) assesses caregiver's impression of participant's overall health state; scores range: 0 to 100. Lower scores indicate greater disease severity.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
2554291|NCT02760602|Secondary|Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)|CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
2554292|NCT02760602|Secondary|Change From Baseline on the Neuropsychiatric Inventory (NPI)|The NPI is a tool for assessing psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. The score ranges from 12 to 144, with higher scores indicating greater disease severity.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
2554293|NCT02760602|Secondary|Change From Baseline on the Functional Activities Questionnaire (FAQ)|FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from Writing checks, Assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, Traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3). The maximum FAQ total score is 30, with higher scores indicating greater impairment.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
2554294|NCT02760602|Secondary|Change From Baseline on the Montreal Cognitive Assessment (MoCA)|The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
2554295|NCT02760602|Secondary|Change From Baseline on the Mini Mental Status Examination (MMSE)|MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants.Total score ranges from 0 to 30; lower score indicates greater disease severity.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
2554296|NCT02760602|Secondary|Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)|The ADCS-MCI-ADL is a functional evaluation scale for MCI patients, based on information provided by an informant that describes the performance of participants in several ADLs. Total score ranges from 0 to 69; lower score indicates greater disease severity.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
2554297|NCT02760602|Primary|Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score|ADAS-Cog14 is ADAS-Cog11 augmented with orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity.|Baseline, 24 Months|Zero participants were analyzed as no data collected.||||||
2554298|NCT02760277|Secondary|Muscle Strength, Mobility, and Functional Exercise Capacity vs. Historical Controls as Measured by 6-minute Walk Test (6MWT) Meters|To investigate the effects of vamorolone, administered orally at daily doses up to 6.0 mg/kg over a 24-week Treatment Period, on muscle strength, mobility and functional exercise capacity vs. historical controls as measured by 6-minute Walk Test (6MWT) in boys ages 4-7 years with DMD.|002 Baseline, 003 Baseline, 003 Week 12, 003 Week 24 (Note: 002 Baseline is from VBP15-002 4 week study (NCT02760264), previous to VBP15-003)|All subjects who receive at least one dose of vamorolone study medication in the extension study will be included in the Safety Population. The Safety Population is the primary analysis population for safety assessments.|||Meters||Standard Deviation|Mean
2554299|NCT02760277|Secondary|Muscle Strength, Mobility, and Functional Exercise Capacity as Measured by North Star Ambulatory Assessment (NSAA)|To investigate the effects of vamorolone, administered orally at daily doses up to 6.0 mg/kg over a 24-week Treatment Period, on muscle strength, mobility and functional exercise capacity vs. historical controls as measured by North Star Ambulatory Assessment (NSAA) in boys ages 4-7 years with DMD. ***Total NSAA score is being reported. The score can range from 0 to 32. Higher scores (approaching 32) indicate a better outcome assessing functional mobility.|002 Baseline, 003 Baseline, 003 Week 12, 003 Week 24 (Note: 002 Baseline is from VBP15-002 4 week study (NCT02760264), previous to VBP15-003)|All subjects who receive at least one dose of vamorolone study medication in the extension study will be included in the Safety Population. The Safety Population is the primary analysis population for safety assessments.|||scores on a scale||Standard Deviation|Mean
2554300|NCT02760277|Secondary|Muscle Strength, Mobility, and Functional Exercise Capacity as Measured by Time to Run/Walk 10 Meters Test (TTRW)- Velocity|To investigate the effects of vamorolone, administered orally at daily doses up to 6.0 mg/kg over a 24-week Treatment Period, on muscle strength, mobility and functional exercise capacity vs. historical controls as measured by Time to Run/Walk Test (TTRW) in boys ages 4-7 years with DMD.|002 Baseline, 003 Baseline, 003 Week 12, 003 Week 24 (Note: 002 Baseline is from VBP15-002 4 week study (NCT02760264), previous to VBP15-003)|All subjects who receive at least one dose of vamorolone study medication in the extension study will be included in the Safety Population. The Safety Population is the primary analysis population for safety assessments.|||meters/ second||Standard Deviation|Mean
2554301|NCT02760277|Secondary|Muscle Strength, Mobility, and Functional Exercise Capacity as Measured by Time to Climb Test (TTCLIMB)- Velocity|To investigate the effects of vamorolone, administered orally at daily doses up to 6.0 mg/kg over a 24-week Treatment Period, on muscle strength, mobility and functional exercise capacity vs. historical controls as measured by Time to Climb Test (TTCLIMB) in boys ages 4-7 years with DMD.|002 Baseline, 003 Baseline, 003 Week 12, 003 Week 24 (Note: 002 Baseline is from VBP15-002 4 week study (NCT02760264), previous to VBP15-003)|All subjects who receive at least one dose of vamorolone study medication in the extension study will be included in the Safety Population. The Safety Population is the primary analysis population for safety assessments.|||tasks/ second||Standard Deviation|Mean
2554302|NCT02760277|Secondary|Serum Pharmacodynamics Biomarkers Measured by Levels of CTX|To investigate the effects of vamorolone, administered orally at daily doses up to 6.0 mg/kg over a 24-week Treatment Period vs. prednisone-treated historical controls, on serum pharmacodynamic (PD) biomarkers of safety (insulin resistance, adrenal axis suppression, and bone turnover). SomaScan aptamer panels testing 1,200 serum proteins were used to discover a candidate set of prednisone-responsive biomarkers, with a subset of these validating in a longitudinal sample set (individual DMD patients pre/post steroid treatment). These PD biomarkers were assigned to a safety panel or efficacy panel based on comparison to normal controls and information concerning the function of each protein.|002 Baseline, 003 Baseline, 003 Week 8, 003 Week 16, Week 24, 003 Week 26-29 (Note: 002 Baseline is from VBP15-002 4 week study (NCT02760264), previous to VBP15-003)|All subjects who receive at least one dose of vamorolone study medication in the extension study will be included in the Safety Population. The Safety Population is the primary analysis population for safety assessments.|||pg/mL||Standard Deviation|Mean
2554303|NCT02760277|Secondary|Serum Pharmacodynamics Biomarkers Measured by Levels of P1NP|To investigate the effects of vamorolone, administered orally at daily doses up to 6.0 mg/kg over a 24-week Treatment Period vs. prednisone-treated historical controls, on serum pharmacodynamic (PD) biomarkers of safety (insulin resistance, adrenal axis suppression, and bone turnover). SomaScan aptamer panels testing 1,200 serum proteins were used to discover a candidate set of prednisone-responsive biomarkers, with a subset of these validating in a longitudinal sample set (individual DMD patients pre/post steroid treatment). These PD biomarkers were assigned to a safety panel or efficacy panel based on comparison to normal controls and information concerning the function of each protein.|002 Baseline, 003 Baseline, 003 Week 8, 003 Week 16, 003 Week 24, 003 Week 26-29 (Note: 002 Baseline is from VBP15-002 4 week study (NCT02760264), previous to VBP15-003)|All subjects who receive at least one dose of vamorolone study medication in the extension study will be included in the Safety Population. The Safety Population is the primary analysis population for safety assessments.|||ng/mL||Standard Deviation|Mean
2554304|NCT02760277|Secondary|Serum Pharmacodynamics Biomarkers Measured by Levels of Osteocalcin|To investigate the effects of vamorolone, administered orally at daily doses up to 6.0 mg/kg over a 24-week Treatment Period vs. prednisone-treated historical controls, on serum pharmacodynamic (PD) biomarkers of safety (insulin resistance, adrenal axis suppression, and bone turnover). SomaScan aptamer panels testing 1,200 serum proteins were used to discover a candidate set of prednisone-responsive biomarkers, with a subset of these validating in a longitudinal sample set (individual DMD patients pre/post steroid treatment). These PD biomarkers were assigned to a safety panel or efficacy panel based on comparison to normal controls and information concerning the function of each protein.|002 Baseline, 003 Baseline, 003 Week 8, 003 Week 16, 003 Week 24, 003 Week 26-29 (Note: 002 Baseline is from VBP15-002 4 week study (NCT02760264), previous to VBP15-003)|All subjects who receive at least one dose of vamorolone study medication in the extension study will be included in the Safety Population. The Safety Population is the primary analysis population for safety assessments.|||ng/mL||Standard Deviation|Mean
2554305|NCT02760277|Secondary|Serum Pharmacodynamics Biomarkers Measured by Levels of Fasting Insulin|To investigate the effects of vamorolone, administered orally at daily doses up to 6.0 mg/kg over a 24-week Treatment Period vs. prednisone-treated historical controls, on serum pharmacodynamic (PD) biomarkers of safety (insulin resistance, adrenal axis suppression, and bone turnover). SomaScan aptamer panels testing 1,200 serum proteins were used to discover a candidate set of prednisone-responsive biomarkers, with a subset of these validating in a longitudinal sample set (individual DMD patients pre/post steroid treatment). These PD biomarkers were assigned to a safety panel or efficacy panel based on comparison to normal controls and information concerning the function of each protein.|002 Baseline, 003 Week 12, 003 Week 24|All subjects who receive at least one dose of vamorolone study medication in the extension study will be included in the Safety Population. The Safety Population is the primary analysis population for safety assessments.|||uIU/mL||Standard Deviation|Mean
2554306|NCT02760277|Secondary|Serum Pharmacodynamics Biomarkers Measured by Levels of Fasting Glucose|To investigate the effects of vamorolone, administered orally at daily doses up to 6.0 mg/kg over a 24-week Treatment Period vs. prednisone-treated historical controls, on serum pharmacodynamic (PD) biomarkers of safety (insulin resistance, adrenal axis suppression, and bone turnover). SomaScan aptamer panels testing 1,200 serum proteins were used to discover a candidate set of prednisone-responsive biomarkers, with a subset of these validating in a longitudinal sample set (individual DMD patients pre/post steroid treatment). These PD biomarkers were assigned to a safety panel or efficacy panel based on comparison to normal controls and information concerning the function of each protein.|002 Baseline, 003 Week 12, 003 Week 24|All subjects who receive at least one dose of vamorolone study medication in the extension study will be included in the Safety Population. The Safety Population is the primary analysis population for safety assessments.|||mg/dL||Standard Deviation|Mean
2554307|NCT02760277|Secondary|Serum Pharmacodynamics Biomarkers Measured by Levels of ACTH|To investigate the effects of vamorolone, administered orally at daily doses up to 6.0 mg/kg over a 24-week Treatment Period vs. prednisone-treated historical controls, on serum pharmacodynamic (PD) biomarkers of safety (insulin resistance, adrenal axis suppression, and bone turnover). SomaScan aptamer panels testing 1,200 serum proteins were used to discover a candidate set of prednisone-responsive biomarkers, with a subset of these validating in a longitudinal sample set (individual DMD patients pre/post steroid treatment). These PD biomarkers were assigned to a safety panel or efficacy panel based on comparison to normal controls and information concerning the function of each protein.|002 Baseline, 003 Baseline, 003 Week 8, 003 Week 16, 003 Week 24, 003 Week 26-29 (Note: 002 Baseline is from VBP15-002 4 week study (NCT02760264), previous to VBP15-003)|All subjects who receive at least one dose of vamorolone study medication in the extension study will be included in the Safety Population. The Safety Population is the primary analysis population for safety assessments.|||pg/mL||Standard Deviation|Mean
2554319|NCT02760264|Secondary|Pharmacokinetic (PK) Assessments (Tmax)|Plasma concentrations of vamorolone were measured using a specific and validated liquid chromatography tandem mass spectrometry (LC-MS) assay. tmax= time when plasma concentration is at maximum.|Day 1, Week 2|All subjects who receive at least one dose of vamorolone study medication and have sufficient quantifiable plasma concentration data for PK analysis will be included in the PK population. [Note that the PK population will be determined by the study pharmacokineticist upon review of the concentration information for each subject in each cohort.|||hour||Standard Deviation|Mean
2554308|NCT02760277|Secondary|Serum Pharmacodynamics Biomarkers Measured by Levels of HbA1c|To investigate the effects of vamorolone, administered orally at daily doses up to 6.0 mg/kg over a 24-week Treatment Period vs. prednisone-treated historical controls, on serum pharmacodynamic (PD) biomarkers of safety (insulin resistance, adrenal axis suppression, and bone turnover). SomaScan aptamer panels testing 1,200 serum proteins were used to discover a candidate set of prednisone-responsive biomarkers, with a subset of these validating in a longitudinal sample set (individual DMD patients pre/post steroid treatment). These PD biomarkers were assigned to a safety panel or efficacy panel based on comparison to normal controls and information concerning the function of each protein.|002 Baseline, 003 Week 8, 003 Week 16, 003 Week 24, 003 Week 26-29|All subjects who receive at least one dose of vamorolone study medication in the extension study will be included in the Safety Population. The Safety Population is the primary analysis population for safety assessments.|||% change||Standard Deviation|Mean
2554309|NCT02760277|Secondary|Serum Pharmacodynamics Biomarkers Measured by Levels of HbA1c|To investigate the effects of vamorolone, administered orally at daily doses up to 6.0 mg/kg over a 24-week Treatment Period vs. prednisone-treated historical controls, on serum pharmacodynamic (PD) biomarkers of safety (insulin resistance, adrenal axis suppression, and bone turnover). SomaScan aptamer panels testing 1,200 serum proteins were used to discover a candidate set of prednisone-responsive biomarkers, with a subset of these validating in a longitudinal sample set (individual DMD patients pre/post steroid treatment). These PD biomarkers were assigned to a safety panel or efficacy panel based on comparison to normal controls and information concerning the function of each protein.|002 Baseline, 003 Week 8, 003 Week 16, 003 Week 24, 003 Week 26-29|All subjects who receive at least one dose of vamorolone study medication in the extension study will be included in the Safety Population. The Safety Population is the primary analysis population for safety assessments.|||% of HbA1c||Standard Deviation|Mean
2554310|NCT02760277|Primary|BMI Z-score|"Summary of BMI Z-score of Safety Population.~Please note 0 is the mean. A negative result indicates a response that is many standard deviations below the mean, and a positive result indicates a response that is many standard deviations above the mean. In this case, the closer the group mean BMI Z-score is to 0 is more favorable."|002 Baseline, 003 Week 12, Week 24|All subjects who receive at least one dose of vamorolone study medication in the extension study will be included in the Safety Population. The Safety Population is the primary analysis population for safety assessments.|||z score||Standard Deviation|Mean
2554311|NCT02760277|Primary|Muscle Function Measured by Time to Stand Test (TTSTAND)- Velocity|To compare the efficacy, as measured by the Time to Stand Test (TTSTAND), of vamorolone administered orally at daily doses up to 6.0 mg/kg over a 24-week Treatment Period vs. untreated DMD historical controls in boys ages 4-7 years with DMD|002 Baseline, 003 Baseline, 003 Week 12, Week 24 (Note: 002 Baseline is from VBP15-002 4 week study (NCT02760264), previous to VBP15-003)|All subjects who receive at least one dose of vamorolone study medication in the extension study will be included in the Safety Population. The Safety Population is the primary analysis population for safety assessments.|||Rises/Second||Standard Deviation|Mean
2554312|NCT02760277|Primary|Total Number of Adverse Events as Assessed by CTCAE Version 4.03|Treatment-emergent adverse events (TEAEs) are defined as any adverse event or worsening of an existing conditions after initiation of the investigational product and through the subject's last study visit (study completion or early termination). Serious adverse events were recorded for up to 30 days after the final administration of study drug; To evaluate the long-term safety and tolerability of vamorolone, administered orally at daily doses up to 6.0 mg/kg/day over a 24- week Treatment Period, in boys ages 4-7 years with DMD.|24 weeks|All subjects who receive at least one dose of vamorolone study medication in the extension study will be included in the Safety Population. The Safety Population is the primary analysis population for safety assessments.|||Events|||Number
2554313|NCT02760277|Primary|Number of Participants With Adverse Events as Assessed by CTCAE Version 4.03|Treatment-emergent adverse events (TEAEs) are defined as any adverse event or worsening of an existing conditions after initiation of the investigational product and through the subject's last study visit (study completion or early termination). Serious adverse events were recorded for up to 30 days after the final administration of study drug; To evaluate the long-term safety and tolerability of vamorolone, administered orally at daily doses up to 6.0 mg/kg/day over a 24- week Treatment Period, in boys ages 4-7 years with DMD.|24 weeks|All subjects who receive at least one dose of vamorolone study medication in the extension study will be included in the Safety Population. The Safety Population is the primary analysis population for safety assessments.|||participants|||Number
2554314|NCT02760264|Secondary|Metabolites in Safety Testing (MIST) Assessment|A portion of each blood sample of the Week 2 (Day 14) pharmacokinetic assessment time points for the subjects receiving vamorolone 2 mg/kg/day was used for analysis of vamorolone metabolites.|Week 2 (Day 14)||||% of total drug related exposure||Standard Deviation|Mean
2554315|NCT02760264|Secondary|Pharmacokinetic (PK) Assessments (Cmax)|Plasma concentrations of vamorolone were measured using a specific and validated liquid chromatography tandem mass spectrometry (LC-MS) assay|Day 1, Week 2||||ng/mL||Standard Deviation|Mean
2554316|NCT02760264|Secondary|Pharmacokinetic (PK) Assessments t(1/2)|Plasma concentrations of vamorolone were measured using a specific and validated liquid chromatography tandem mass spectrometry (LC-MS) assay. t1/2= elimination half life.|Day 1, Week 2|All subjects who receive at least one dose of vamorolone study medication and have sufficient quantifiable plasma concentration data for PK analysis will be included in the PK population. [Note that the PK population will be determined by the study pharmacokineticist upon review of the concentration information for each subject in each cohort.|||hour||Standard Deviation|Mean
2554317|NCT02760264|Secondary|Pharmacokinetic (PK) Assessments CL (ml/hr/kg)|Plasma concentrations of vamorolone were measured using a specific and validated liquid chromatography tandem mass spectrometry (LC-MS) assay|Day 1, Week 2||||ml/hr/kg||Standard Deviation|Mean
2554318|NCT02760264|Secondary|Pharmacokinetic (PK) Assessments (AUC Inf)|Plasma concentrations of vamorolone were measured using a specific and validated liquid chromatography tandem mass spectrometry (LC-MS) assay. AUC inf= Area under the concentration vs. time curve to time infinity.|Day 1, Week 2|All subjects who receive at least one dose of vamorolone study medication and have sufficient quantifiable plasma concentration data for PK analysis will be included in the PK population. [Note that the PK population will be determined by the study pharmacokineticist upon review of the concentration information for each subject in each cohort.|||[(hr)(ng)/mL]||Standard Deviation|Mean
2554321|NCT02760264|Secondary|Serum Pharmacodynamic Biomarkers (Bone Turnover)-Type I Collagen C-Telopeptides|Pharmacodynamic biomarkers were measured to investigate the effects of single and multiple oral doses of vamorolone on serum PD biomarkers in ambulant boys ages 4-< 7 years with DMD.|Baseline, Day 1, Week 4|Safety Population: All subjects who receive at least one dose of vamorolone study medication will be included in the Safety Population.|||pg/mL||Standard Deviation|Mean
2554322|NCT02760264|Secondary|Serum Pharmacodynamic Biomarkers (Bone Turnover)- Procollagen 1 N-Terminal Propeptide|Pharmacodynamic biomarkers were measured to investigate the effects of single and multiple oral doses of vamorolone on serum PD biomarkers in ambulant boys ages 4-< 7 years with DMD.|Baseline, Day 1, Week 2, Week 4|Safety Population: All subjects who receive at least one dose of vamorolone study medication will be included in the Safety Population.|||% change from Baseline||Standard Deviation|Mean
2554323|NCT02760264|Secondary|Serum Pharmacodynamic Biomarkers (Bone Turnover)- Procollagen 1 N-Terminal Propeptide|Pharmacodynamic biomarkers were measured to investigate the effects of single and multiple oral doses of vamorolone on serum PD biomarkers in ambulant boys ages 4-< 7 years with DMD.|Baseline Day 1 Week 2 Week 4|Safety Population: All subjects who receive at least one dose of vamorolone study medication will be included in the Safety Population.|||ng/mL||Standard Deviation|Mean
2554324|NCT02760264|Secondary|Serum Pharmacodynamics Biomarkers (Bone Turnover) -Osteocalcin|Pharmacodynamic biomarkers were measured to investigate the effects of single and multiple oral doses of vamorolone on serum PD biomarkers in ambulant boys ages 4-< 7 years with DMD.|Baseline, Day 1, Week 2, Week 4|Safety Population: All subjects who receive at least one dose of vamorolone study medication will be included in the Safety Population.|||% change from Baseline||Standard Deviation|Mean
2554325|NCT02760264|Secondary|Serum Pharmacodynamics Biomarkers (Bone Turnover) -Osteocalcin|Pharmacodynamic biomarkers were measured to investigate the effects of single and multiple oral doses of vamorolone on serum PD biomarkers in ambulant boys ages 4-< 7 years with DMD.|Baseline, Day 1, Week 2, Week 4|Safety Population: All subjects who receive at least one dose of vamorolone study medication will be included in the Safety Population.|||ng/mL||Standard Deviation|Mean
2554326|NCT02760264|Secondary|Serum Pharmacodynamic Biomarkers (Adrenal Axis Suppression)- First in Morning Cortisol|Pharmacodynamic biomarkers were measured to investigate the effects of single and multiple oral doses of vamorolone on serum PD biomarkers in ambulant boys ages 4-< 7 years with DMD.|Week 2 (pre-dose)||||mcg/dL||Standard Deviation|Mean
2554327|NCT02760264|Secondary|Serum Pharmacodynamic Biomarkers (Insulin Resistance)- Insulin|Pharmacodynamic biomarkers were measured to investigate the effects of single and multiple oral doses of vamorolone on serum PD biomarkers in ambulant boys ages 4-< 7 years with DMD.|Baseline, Week 2|Safety Population All subjects who receive at least one dose of vamorolone study medication will be included in the Safety Population.|||Week 2 % change from Baseline||Standard Deviation|Mean
2554328|NCT02760264|Secondary|Serum Pharmacodynamic Biomarkers (Insulin Resistance)- Insulin|Pharmacodynamic biomarkers were measured to investigate the effects of single and multiple oral doses of vamorolone on serum PD biomarkers in ambulant boys ages 4-< 7 years with DMD.|Baseline , Week 2|Safety Population All subjects who receive at least one dose of vamorolone study medication will be included in the Safety Population.|||µIU/mL||Standard Deviation|Mean
2554329|NCT02760264|Secondary|Serum Pharmacodynamic Biomarkers (Insulin Resistance) -Fasting Glucose|Pharmacodynamic biomarkers were measured to investigate the effects of single and multiple oral doses of vamorolone on serum PD biomarkers in ambulant boys ages 4-< 7 years with DMD.|Baseline, Week 2|Safety Population: All subject who receive at least dose of vamorolone study medication will be included in the safety population.|||Week 2 % change from Baseline||Standard Deviation|Mean
2554330|NCT02760264|Secondary|Serum Pharmacodynamic Biomarkers (Insulin Resistance)- Fasting Glucose|Pharmacodynamic biomarkers were measured to investigate the effects of single and multiple oral doses of vamorolone on serum PD biomarkers in ambulant boys ages 4-< 7 years with DMD.|Baseline, Week 2|Safety Population: All subject who receive at least dose of vamorolone study medication will be included in the safety population.|||mg/ dL||Standard Deviation|Mean
2554331|NCT02760264|Primary|Overall Summary of Adverse Events as Assessed by CTCAE Version 4.03|"Treatment-emergent adverse events (TEAEs) are defined as any adverse event or worsening of an existing conditions after initiation of the investigational product and through the subject's last study visit (study completion or early termination). Serious adverse events were recorded for up to 30 days after the final administration of study drug.~Note: Total Number of Treatment Emergent Adverse Events: The total incidences of TEAEs experienced in study; Any Treatment Emergent Adverse Event: TEAEs reported at least once per dose group"|Adverse events will be recorded from the date of informed consent and through the time of the subject's last study visit. Serious adverse events will be recorded from the date of informed consent and for up to 30 days after final drug administration.|Safety Population: All subjects who receive at least one dose of vamorolone study medication will be included in safety population.|||Number of Events|||Number
2554332|NCT02760056|Secondary|Reliability of Visual Evoked Potential (VEP) Testing (ICC)|P100 latency will be compared before and after treatment with L-T3 in subjects receiving the active treatment to assess reliability of the test for future assessment of treatment effect.|1 week|Participants with MS taking L-T3 or placebo|||Intraclass Coefficient (ICC)|||Number
2554333|NCT02760056|Primary|Determine the Maximum Tolerated Dose (MTD) of Oral L-T3 in Subjects With MS|MTD per protocol (dose level one category below dose at which study was stopped due to intolerance or meeting criteria for cessation)|1 week|Participants with MS taking L-T3 (10) excluding those taking placebo (5)|||mcg daily with BID dosing|||Number
2554334|NCT02759939|Other Pre-specified|Acceptability of Decision Aid(s)|The acceptability of the decision aid(s) to participants, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]|||||||
2554367|NCT02759471|Primary|Lens Fit - Corneal Coverage|Lens fit evaluation of corneal coverage for comfilcon A sphere and comfilcon A asphere lens. ('yes' - full coverage, or 'no' - incomplete corneal coverage).|baseline, 2 weeks, 1 month|One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.|||participants|||Number
2554335|NCT02759939|Other Pre-specified|Acceptability of Video|The acceptability of the video to participants, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]|||||||
2554336|NCT02759939|Other Pre-specified|Exposure to Decision Aid(s)|Participants' exposure to one or more of the decision aids and timing of exposure, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]|||||||
2554337|NCT02759939|Other Pre-specified|Use of Three Questions|Participants' use of each of the three patient questions in the health care visit, measured using three adapted items (Shepherd et al., 2015). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]|||||||
2554338|NCT02759939|Other Pre-specified|Exposure to Prompt Card|Participants' exposure to the prompt card and timing of exposure, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]|||||||
2554339|NCT02759939|Other Pre-specified|Exposure to Video|Participants' exposure to the video and timing of exposure, measured using an adapted item (Shepherd et al., 2015). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]|||||||
2554340|NCT02759939|Secondary|Unwelcome Pregnancy|Participants' experience of one or more unwelcome pregnancies since the health care visit, measured using an adapted item (Centers for Disease Control and Prevention, 2012). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]|||||||
2554341|NCT02759939|Secondary|Unintended Pregnancy (Pregnancy Seeking)|Participants' experience of one or more unintended pregnancies since the health care visit (as defined by their pregnancy seeking), measured using an adapted item (Kavanaugh & Schwarz, 2009). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]|||||||
2554342|NCT02759939|Secondary|Unintended Pregnancy (Pregnancy Timing Preferences)|Participants' experience of one or more unintended pregnancies since the health care visit (as defined by their pregnancy timing preferences), measured using an adapted item (Centers for Disease Control and Prevention, 2012). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]|||||||
2554343|NCT02759939|Secondary|Satisfaction With Contraceptive Method(s) Used|Participants' satisfaction with the contraceptive method(s) they used in the last four weeks, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]|||||||
2554344|NCT02759939|Secondary|Adherence to Contraceptive Method(s) Used|Participants' adherence to the contraceptive method(s) they used in the last four weeks, measured using a self-developed, 21-item measure. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]|||||||
2554345|NCT02759939|Secondary|Use of Intended Contraceptive Method(s)|Whether participants used their intended contraceptive method(s) in the last four weeks, derived from data on intended contraceptive method(s) and contraceptive method(s) used. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]|||||||
2554346|NCT02759939|Secondary|Use of a Highly Effective Contraceptive Method|Whether participants used at least one highly effective contraceptive method in the last four weeks, derived from data on contraceptive method(s) used. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]|||||||
2554347|NCT02759939|Secondary|Contraceptive Method(s) Used|What, if any, contraceptive method(s) participants used in the last four weeks, measured using a self-developed checklist. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]|||||||
2554348|NCT02759939|Secondary|Decision Regret About Intended Contraceptive Method(s)|Participants' feelings of decision regret about the contraceptive method(s) they intended to use, measured using an adaptation of the five-item Decision Regret Scale (Brehaut et al., 2003; O'Connor, 1996). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|4 weeks after the index health care visit (T2); 6 months after the index health care visit (T3) [for both pre-implementation and post-implementation participants]|||||||
2554349|NCT02759939|Secondary|Values Concordance of Intended Contraceptive Method(s)|Participants' perceptions of the degree of concordance between the contraceptive method(s) they intend(ed) to use and their individual values, needs, and preferences, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|Immediately after the index health care visit (T1); 4 weeks after the index health care visit (Time 2 (T2)); 6 months after the index health care visit (Time 3 (T3)) [for both pre-implementation and post-implementation participants]|||||||
2554350|NCT02759939|Secondary|Intention to Use a Highly Effective Contraceptive Method|Whether participants intend to use at least one highly effective contraceptive method in the next four weeks, derived from data on intended contraceptive method(s). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]|||||||
2554351|NCT02759939|Secondary|Intended Contraceptive Method(s)|What, if any, contraceptive method(s) participants intend to use in the next four weeks, measured using a self-developed checklist. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]|||||||
2554352|NCT02759939|Secondary|Satisfaction With Conversation About Contraception|Participants' satisfaction with the conversation about contraception in the health care visit, measured using an adapted item (Weisman et al., 2002). Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]|||||||
2554353|NCT02759939|Secondary|Conversation About Contraception|Whether participants experienced a conversation about contraception in the health care visit, measured using a self-developed item. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|Immediately after the index health care visit (T1) [for both pre-implementation and post-implementation participants]|||||||
2554354|NCT02759939|Primary|Shared Decision-making About Contraceptive Methods|Shared decision-making about contraceptive methods in the health care visit, measured using the three-item CollaboRATE measure (Barr et al., 2014; Elwyn et al., 2013). We used the version of CollaboRATE with a five-point response scale and adopted the binary scoring approach, which yields a score of 0 (no shared decision-making) and 1 (shared decision-making) for each participant. Note: 'pre-implementation participants' comprise those enrolled in the trial before clinics began implementing interventions and 'post-implementation participants' comprise those enrolled in the trial after clinics began implementing interventions (if relevant).|Immediately after the index health care visit (Time 1 (T1)) [for both pre-implementation and post-implementation participants]|Participants with valid data on the primary outcome of shared decision-making about contraceptive methods and all covariates included in the adjusted analytic model. Data were collected at three time points from samples receiving care before (pre-implementation) and after (post-implementation) introduction of any intervention(s).|||Participants|||Count of Participants
2554355|NCT02759692|Secondary|Individual Patient Reported Outcomes (Items 15-17)|"Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space). 15.Clarity of vision during daily activities 16.Clarity of vision in dim or low lighting conditions 17. Clarity of visions when driving at night."|7-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Responses|Observations||Number
2554368|NCT02759471|Primary|Lens Fit - Centration|Lens fit evaluation of centration for comfilcon A sphere and comfilcon A asphere lens. (Scale: optimum, decentration acceptable and decentration unacceptable).|baseline, 2 weeks, 1 month|One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.|||participants|||Number
2554496|NCT02757430|Primary|Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With TurboMap Module Mapping|mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: TurboMap module|during procedure|13 total TurboMap Module maps were created.|||min|TurboMap Module Maps|Standard Deviation|Mean
2554356|NCT02759692|Secondary|Individual Patient Reported Outcomes (Items 11-14)|"Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space). 11.I was very satisfied with my distance vision when i first put these lenses in my eyes. 12.I was very satisfied by the clarity of my vision at the end of the day 13.I was satisfied with the quality of my vision at night 14.With these lenses, I felt very confident to drive at night"|7-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Responses|Observations||Number
2554357|NCT02759692|Secondary|Individual Patient Reported Outcomes (Items 6-10)|"Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space)6. Comfort at the end of the day 7. They remained comfortable from the moment I put them in until the moment I took them out 8.Comfort from activity to activity 9. Comfort across different environments 10.Comfort while working on a computer"|7-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Responses|Observations||Number
2554358|NCT02759692|Secondary|Individual Patient Reported Outcomes (Items 1-5)|"Individual patient reported outcomes questions were used to assess patient-experience attributes of soft contact lenses (e.g. comfort and vision). Items were assessed at the 7-Day follow-up using a 5-point scale of either (1) Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree or (2) Poor, Fair, Good, Very Well, Excellent. Subject's responses for each item were dichotomoized into top-two-box (T2B) response where T2B=1 if a subject responded positively to the question which is dependent on the response set) and T2B=0 otherwise. The percentage of T2B for each item and lens was reported. The following items were asked: ([] indicate the question was abbreviated due to space)1.These Lenses Were Very Comfortable At The End Of The Day 2.The Comfort of these lenses decreased throughout the day 3. The lenses were very comfortable from the time I got up to the time I went to bed 4. Overall Comfort 5. Comfort throughout the Day"|7-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Responses|Observations||Number
2554359|NCT02759692|Primary|Overall Quality of Vision|Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.|7-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Units on a Scale|Observations|Standard Deviation|Mean
2554360|NCT02759692|Primary|Overall Comfort|Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 132+136+132=400 (Observations- 1 per subject per period) from period 1, 2 and 3 respectively. For the stenfilcon A lens 136+132+136=404 (observations) from period 1, 2 and 3 respectively.|7-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Units on a Scale|Observations|Standard Deviation|Mean
2554361|NCT02759562|Secondary|Relative Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8||Baseline; Week 8|Full Analysis Set|||percent change||Standard Deviation|Mean
2554362|NCT02759562|Secondary|Relative Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8||Baseline; Week 8|Full Analysis Set|||percent change||Standard Deviation|Mean
2554363|NCT02759562|Secondary|Absolute Change in Post-bronchodilator FEV1 Percent Predicted From Baseline to Week 8||Baseline; Week 8|Full Analysis Set|||percent||Standard Deviation|Mean
2554364|NCT02759562|Primary|Absolute Change in Pre-bronchodilator FEV1 Percent Predicted From Baseline to Week 8||Baseline; Week 8|Full Analysis Set: all randomized participants who took at least 1 dose of study drug.|||percent||Standard Deviation|Mean
2554365|NCT02759471|Primary|Lens Preference/Acceptability|Investigators preference/acceptability for comfilcon A sphere and comfilcon A asphere lenses. (Choices: strongly prefer study lenses, slightly prefer study lenses, slightly prefer habitual lenses, strongly prefer habitual lenses).|baseline, 2 weeks, 1 month||||participants|||Number
2554366|NCT02759471|Primary|Lens Fit - Post-blink Movement|Lens fit evaluation of post-blink movement for comfilcon A sphere and comfilcon A asphere lens. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).|baseline, 2 weeks, 1 month|One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.|||units on a scale||Standard Deviation|Mean
2554369|NCT02759354|Other Pre-specified|Percentage of Participants With One or More Serious Adverse Events Related to Study Procedure|An SAE is any untoward medical occurrence or effect that at any dose results in death or is life threatening. Life-threatening in this context refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it was more severe.|Up to 4 days following blood sample on Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule)|All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated (with a complete 3+1 or 2+1 schedule, as part of studies V419-007 or V419-008) with available immunogenicity data for the respective endpoint.|||Percentage of Participants|||Number
2554370|NCT02759354|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.|Day 1 (approximately 4 years after completion of the 2+1 schedule)|The analysis population was the Persistence Analysis Set, all participants previously vaccinated with complete 2+1 schedule (V419-008) with available immunogenicity data for the respective endpoint. Due to pre-school enrollment and booster administration, assessment of pertussis antibody persistence was not possible for the 3+1 schedule (V419-007).|||EU/mL||95% Confidence Interval|Geometric Mean
2554371|NCT02759354|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.|Day 1 (approximately 4 years after completion of the 2+1 schedule)|The analysis population was the Persistence Analysis Set, all participants previously vaccinated with complete 2+1 schedule (V419-008) with available immunogenicity data for the respective endpoint. Due to pre-school enrollment and booster administration, assessment of pertussis antibody persistence was not possible for the 3+1 schedule (V419-007).|||EU/mL||95% Confidence Interval|Geometric Mean
2554372|NCT02759354|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.|Day 1 (approximately 4 years after completion of the 2+1 schedule)|The analysis population was the Persistence Analysis Set, all participants previously vaccinated with complete 2+1 schedule (V419-008) with available immunogenicity data for the respective endpoint. Due to pre-school enrollment and booster administration, assessment of pertussis antibody persistence was not possible for the 3+1 schedule (V419-007).|||EU/mL||95% Confidence Interval|Geometric Mean
2554373|NCT02759354|Primary|Percentage of Participants Responding to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. LLOQ=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.|Day 1 (approximately 4 years after completion of the 2+1 schedule)|The analysis population was the Persistence Analysis Set, all participants previously vaccinated with complete 2+1 schedule (V419-008) with available immunogenicity data for the respective endpoint. Due to pre-school enrollment and booster administration, assessment of pertussis antibody persistence was not possible for the 3+1 schedule (V419-007).|||Percentage of participants||95% Confidence Interval|Number
2554374|NCT02759354|Primary|Percentage of Participants Responding to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. LLOQ=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.|Day 1 (approximately 4 years after completion of the 2+1 schedule)|The analysis population was the Persistence Analysis Set, all participants previously vaccinated with complete 2+1 schedule (V419-008) with available immunogenicity data for the respective endpoint. Due to pre-school enrollment and booster administration, assessment of pertussis antibody persistence was not possible for the 3+1 schedule (V419-007).|||Percentage of participants||95% Confidence Interval|Number
2554375|NCT02759354|Primary|Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. LLOQ=3 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.|Day 1 (approximately 4 years after completion of the 2+1 schedule)|The analysis population was the Persistence Analysis Set, all participants previously vaccinated with complete 2+1 schedule (V419-008) with available immunogenicity data for the respective endpoint. Due to pre-school enrollment and booster administration, assessment of pertussis antibody persistence was not possible for the 3+1 schedule (V419-007).|||Percentage of participants||95% Confidence Interval|Number
2554376|NCT02759354|Primary|Percentage of Participants Responding to Pertussis Toxin|Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for antibodies to pertussis toxin. The unit of measure is ELISA units/mL. The lower limit of quantification (LLOQ)=4 EU/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.|Day 1 (approximately 4 years after completion of the 2+1 schedule)|The analysis population was the Persistence Analysis Set, all participants previously vaccinated with complete 2+1 schedule (V419-008) with available immunogenicity data for the respective endpoint. Due to pre-school enrollment and booster administration, assessment of pertussis antibody persistence was not possible for the 3+1 schedule (V419-007).|||Percentage of participants||95% Confidence Interval|Number
2554377|NCT02759354|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL). Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.|Day 1 (approximately 4 years after completion of the 2+1 schedule)|The analysis population was the Persistence Analysis Set, all participants previously vaccinated with complete 2+1 schedule (V419-008) with available immunogenicity data for the respective endpoint. Due to pre-school enrollment and booster administration, assessment of pertussis antibody persistence was not possible for the 3+1 schedule (V419-007).|||EU/mL||95% Confidence Interval|Geometric Mean
2554407|NCT02758132|Other Pre-specified|Measure Change in Technetium Bone Scintigraphy on Therapy Via Technetium Bone Scintigraphy or Sodium Fluoride (NaF) PET/CT Imaging||Prior to Registration, Day 1 of cycle 4 and 13, Post-Treatment Follow-up (up to 5 years post treatment)|one subject enrolled and they discontinued early from trial, no analysis conducted||||||
2554378|NCT02759354|Secondary|Geometric Mean Concentration of Antibodies to HBsAg|Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to HBsAg. The unit of measure is milli International Units/mL (mIU/mL). Confidence Intervals were calculated based on the t-distribution of the log-transformed antibody concentration.|Day 1 (approximately 4 years after completion of the 3+1 or 2+1 schedule)|All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated (with a complete 3+1 or 2+1 schedule, as part of studies V419-007 or V419-008) with available immunogenicity data for the respective endpoint.|||mIU/mL||95% Confidence Interval|Geometric Mean
2554379|NCT02759354|Primary|Percentage of Participants Responding to Hepatitis B Surface Antigen (HBsAg)|Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to HBsAg. Response was defined as a titer >=10 milli International units (mIU)/mL. Confidence Intervals were calculated based on the exact binomial method of D. Collett.|Day 1 (approximately 4 years after completion of the 3+1/2+1 schedule)|All analyses were performed on the Persistence Analysis Set, defined as all participants previously vaccinated (with a complete 3+1 or 2+1 schedule, as part of studies V419-007 or V419-008) with available immunogenicity data for the respective endpoint.|||Percentage of Participants||95% Confidence Interval|Number
2554380|NCT02759315|Primary|Percentage of Participants With ≥1 Events of Clinical Interest (ECIs)|The percentage of participants with ECIs was determined. ECIs were defined as the following: 1) an overdose of study drug; 2) first instance of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >500 IU/L; 3) first instance of ALT or AST >3x nadir and >3x upper limit of normal (ULN); 4) first instance of estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2; or 4) first instance of serum creatinine >1.3x ULN and elevated from baseline.|Up to Week 14 (up to 2 weeks after completing study therapy)|All participants who received ≥1 dose of study drug are included.|||Percentage of Participants|||Number
2554381|NCT02759315|Secondary|Percentage of Participants With Baseline Resistance-Associated Substitutions (RAS) Achieving SVR12|The percentage of participants in each arm with baseline RAS achieving SVR12 was determined. Analysis of RAS in NS5A or NS5B at baseline was determined. SVR12 was defined as HCV RNA levels in plasma < LLOQ 24 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.|12 weeks after the end of all study therapy (24 weeks)|All participants who received ≥1 dose of study treatment, and who do not have protocol deviations that could substantially affect the results of the endpoint, and who did not discontinue from the study for non-treatment-related reasons, and who had baseline sequencing data available, are included.|||Percentage of Participants|||Number
2554382|NCT02759315|Secondary|Percentage of Participants With Virologic Failure (VF)|The percentage of participants in each arm experiencing VF was determined. VF was defined as: 1) non-response (HCV RNA detected at end of treatment without HCV RNA < LLOQ while on treatment); 2) rebound (>1 log 10 IU/mL increase in HCV RNA from nadir while on treatment); 3) virologic breakthrough (HCV RNA ≥LLOQ after being <LLOQ on treatment); or 4) relapse (HCV RNA ≥LLOQ after end of all study therapy after being undetectable at end of treatment); virologic failure could occur either on-treatment or relapse post-treatment. For VF, participants with GT1 infection were separated into GT1a or GT1b infection|12 weeks after the end of all study therapy (24 weeks)|All participants who received ≥1 dose of study treatment, have data available, who do not have protocol deviations that could substantially affect the results of the endpoint, and who did not discontinue from the study for non-treatment-related reasons, are included.|||Percentage of Participants|||Number
2554383|NCT02759315|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)|The percentage of participants in each arm achieving SVR24 was determined. SVR24 was defined as HCV RNA levels in plasma < LLOQ 24 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. For SVR24, participants with GT1 infection were separated into GT1a or GT1b infection.|Week 36 (24 weeks after completing study therapy)|All participants who received ≥1 dose of study treatment, have data available, who do not have protocol deviations that could substantially affect the results of the endpoint, and who did not discontinue from the study for non-treatment-related reasons, are included.|||Percentage of Participants|||Number
2554384|NCT02759315|Primary|Percentage of Participants Withdrawing From Study Therapy Due to an AE|The percentage of participants discontinuing from study therapy during the treatment period was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.|Up to Week 12|All participants who received ≥1 dose of study drug are included.|||Percentage of Participants|||Number
2554385|NCT02759315|Primary|Percentage of Participants With ≥1 Adverse Events (AEs)|The percentage of participants experiencing an AE during the treatment period and first 2 weeks of follow-up was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.|Up to Week 14 (up to 2 weeks after completing study therapy)|All participants who received ≥1 dose of study drug are included.|||Percentage of Participants|||Number
2554386|NCT02759315|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)|The percentage of participants in each arm achieving SVR12 was determined. SVR12 was defined as HCV ribonucleic acid (RNA) levels in plasma < lower limit of quantification (LLOQ) 12 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.|Week 24 (12 weeks after completing study therapy)|All participants who received ≥1 dose of study treatment, have data available, who do not have protocol deviations that could substantially affect the results of the endpoint, and who did not discontinue from the study for non-treatment-related reasons, are included.|||Percentage of Participants||95% Confidence Interval|Number
2554408|NCT02758132|Secondary|Measure Time (Months) to Duration of Response of Patients on Therapy.||Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment|Patient expired before completing study||||||
2554387|NCT02758613|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Baricitinib|Area under the concentration versus time curve from zero to infinity (AUC0-inf) during single dose and area under the concentration versus time curve (AUCtau,ss) during multiple dose of baricitinib at steady state.|Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose; Day 5: Predose; Day 6: Predose; Day 7: Predose; Day 8: Predose; Day 9: Predose; Day 10: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose|All randomized participants who received at least 1 dose of baricitinib and had evaluable PK data.|||nanogram * hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2554388|NCT02758613|Secondary|Pharmacokinetics(PK): Maximum Concentration (Cmax) of Baricitinib|Maximum observed drug concentration for single dose and Cmax as steady date for multiple dosing.|Day 1: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose; Day 5: Predose; Day 6: Predose; Day 7: Predose; Day 8: Predose; Day 9: Predose; Day 10: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours Postdose|All randomized participants who received at least one dose of baricitinib and had evaluable PK data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2554389|NCT02758613|Primary|Number of Participants With One or More Clinically Significant Event(s)|Clinically significant events were defined as a moderate to severe adverse event, abnormal clinical sign, or clinical laboratory finding that may pose risk to the well-being of the participant. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.|Baseline through Study Completion (up to Day 20)|All randomized participants who received at least one dose of study drug and experienced clinically significant event.|||Participants|||Count of Participants
2554390|NCT02758301|Primary|Number of Participants With a LINQ Device Experiencing a Second Acute Decompensated Heart Failure (ADHF) Events|"A heart failure (HF) event is defined as any cardiovascular-related Health Care Utilizations (HCUs) for any one of the following events.~Admission with primary diagnosis of HF~Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings:~Admission with secondary/tertiary diagnosis of HF~Emergency Department~Ambulance~Observation Unit~Urgent Care~HF/Cardiology Clinic~Up to two ADHF events per subject were intended to be evaluated. The first must be at least 30 days post-Reveal LINQ insertion, and the second, summarized in this section, must be greater than 90 days following the first ADHF event.~Only subjects with a LINQ device were included in the analysis, as the goal was to acquire LINQ-collected data leading up to the ADHF event."|> 90 days following first Acute Decompensated Heart Failure event to 3 years post-implant|Subjects who experienced an ADHF event at least 30 days post-Reveal LINQ insertion|||participants|||Number
2554391|NCT02758301|Primary|Number of Participants With Reveal Device Experiencing an Initial Acute Decompensated Heart Failure (ADHF) Event|"A heart failure (HF) event is defined as any cardiovascular-related Health Care Utilizations (HCUs) for any one of the following events.~Admission with primary diagnosis of HF~Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings:~Admission with secondary/tertiary diagnosis of HF~Emergency Department~Ambulance~Observation Unit~Urgent Care~HF/Cardiology Clinic~Up to 2 ADHF events were intended to be allowed per subject:~One had to be at least 30 days post-Reveal LINQ insertion and is summarized in this section, and~A possible second ADHF event must be greater than 90 days after the first ADHF event~Only subjects with a LINQ device were included in the analysis, as the goal was to acquire LINQ-collected data leading up to the ADHF event."|30 days post-Reveal LINQ insertion to 3 years post-implant|Subjects inserted with a Reveal LINQ device|||participants|||Number
2554392|NCT02758210|Secondary|Number of Participants Reporting Clinical Symptoms While Using a Tablet|Participants were asked to report any clinical symptoms that they experienced when using the tablet.|Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)||||Participants|||Count of Participants
2554393|NCT02758210|Secondary|Number of Participants Reporting Clinical Symptoms While Using a Smart Phone|Participants were asked to report any clinical symptoms that they experienced when using the smart phone.|Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)||||Participants|||Count of Participants
2554394|NCT02758210|Primary|Device Response While Using a Tablet, Assessed by Ventricular Pacing|Ventricular pacing before and during use of a tablet was monitored to assess if there's inhibition of ventricular pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the tablet usage. The assessment of this outcome measure takes an average of 5 minutes.|Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)||||millivolts (mV)||Standard Deviation|Mean
2554395|NCT02758210|Primary|Number of Participants Experiencing Inhibition of Ventricular Pacing While Using a Smart Phone|Ventricular pacing before and during use of a smart phone was monitored to assess the presence of inhibition of ventricular pacing due to electromagnetic field exposure. The programmed pacing of the MICRA device is specific for each participant. The individualized, initial programmed pacing settings of the MICRA device are compared to any changes during the smart phone usage.|Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)||||Participants|||Count of Participants
2554396|NCT02758210|Primary|Number of Participants Experiencing Asynchronous Pacing While Using a Tablet|Cardiac pacing before and during use of a tablet were monitored to assess if there is asynchronous pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the tablet usage.|Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)||||Participants|||Count of Participants
2554397|NCT02758210|Primary|Device Response Assessed by Asynchronous Pacing When Using a Smart Phone|Cardiac pacing before and during use of a smart phone was monitored to assess asynchronous pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the smart phone usage.|Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)||||ohms||Standard Deviation|Mean
2554409|NCT02758132|Secondary|Measure Time (Months) to Progression-free Survival of Patients on Therapy||Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment|Patient expired before completing study||||||
2554398|NCT02758171|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"This outcome measure presents area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 extrapolated to infinity.~Time frame description: The time -1:00h was approximate; the procedure was to be performed and completed within 2h before drug administration. PKS including participants with available data for (area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 extrapolated to infinity)."|1:00 [hour (h): minute] before drug administration and 0:20h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, and 72:00h after drug administration.|PharmacoKinetic parameter analysis Set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2554399|NCT02758171|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"This outcome measure presents area under the concentration-time curve of Empagliflozin in plasma over the time interval from 0 extrapolated to infinity.~Time frame description: The time -1:00h was approximate; the procedure was to be performed and completed within 2h before drug administration. PKS including participants with available data for AUC0-infinity (area under the concentration-time curve of Empagliflozin in plasma over the time interval from 0 extrapolated to infinity)."|1:00 [hour (h): minute] before drug administration and 0:20h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, and 72:00h after drug administration.|PharmacoKinetic parameter analysis Set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2554400|NCT02758171|Primary|Cmax (Maximum Measured Concentration of Linagliptin Analyte in Plasma)|"This outcome measure presents maximum measured concentration of Linagliptin analyte in plasma.~Time frame description: The time -1:00h was approximate; the procedure was to be performed and completed within 2h before drug administration. PKS including participants with available data for Cmax (maximum measured concentration of Linagliptin analyte in plasma)."|1:00 [hour (h): minute] before drug administration and 0:20h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, and 72:00h after drug administration.|PharmacoKinetic parameter analysis Set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2554401|NCT02758171|Primary|Cmax (Maximum Measured Concentration of Empagliflozin Analyte in Plasma)|"This outcome measure presents maximum measured concentration of Empagliflozin analyte in plasma.~Time frame description: The time -1:00h was approximate; the procedure was to be performed and completed within 2h before drug administration. PKS including participants with available data for Cmax (maximum measured concentration of Empagliflozin analyte in plasma)."|1:00 [hour (h): minute] before drug administration and 0:20h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, and 72:00h after drug administration.|PharmacoKinetic parameter analysis Set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2554402|NCT02758171|Primary|AUC0-72 (Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours)|"This outcome measure presents area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 to 72 hours.~Time frame description: The time -1:00h was approximate; the procedure was to be performed and completed within 2h before drug administration. PKS including participants with available data for AUC0-72 (area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 to 72 hours)."|1:00 [hour (h): minute] before drug administration and 0:20h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, and 72:00h after drug administration.|PharmacoKinetic parameter analysis Set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2554403|NCT02758171|Primary|AUC0-tz (Area Under the Concentration-time Curve of Empagliflozin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)|"This outcome measure presents area under the concentration-time curve of Empagliflozin in plasma over the time interval from 0 to the last quantifiable data point.~Time frame description: The time -1:00 hour (h) was approximate; the procedure was to be performed and completed within 2h before drug administration. PKS including participants with available data for AUC0-tz (area under the concentration-time curve of Empagliflozin in plasma over the time interval from 0 to the last quantifiable data point)."|1:00 [hour (h): minute] before drug administration and 0:20h, 0:40h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, and 72:00h after drug administration.|PharmacoKinetic parameter analysis Set (PKS): This subject set included all subjects from the TS who provided at least 1 primary or secondary PK parameter that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2554404|NCT02758132|Other Pre-specified|Evaluate the Effect of Therapy on Narcotic Use in Patients on Therapy Via Case Report Forms.||Prior to Registration, Registration, Day 1 of cycle 4 and 13|one subject enrolled and they discontinued early from trial, no analysis conducted||||||
2554405|NCT02758132|Other Pre-specified|Evaluate the Effect of Therapy on Quality of Life (QoL) in Patients Via QoL Questionnaire.||Prior to Registration, Registration, Day 1 of cycle 4 and 13|one subject enrolled and they discontinued early from trial, no analysis conducted||||||
2554406|NCT02758132|Other Pre-specified|Measure Change in Treatment Response Via RECIST Criteria||Day 1 of each S.O.C cycle (28 days), and until confirmed radiographic disease progression AND initiation of other standard OR investigational agents for prostate cancer, up to 5 years post treatment|one subject enrolled and they discontinued early from trial, no analysis conducted||||||
2554412|NCT02758119|Secondary|Score (on the Checklist) on the First Attempt During the hands-on Session|"Name: Checklist for performance score of SCA management This checklist was adapted from the 2015 resuscitation guidelines. Points were given for the actions performed correctly in sequence and in time(sequence score, 0 to 4),and for the quality of the chest compressions (compression score,0 to 8). The minimum passing score on this checklist was 11 out of 12 (min 0-max 12), with the absolute requirement to score the maximum 4 points on the sequence score.~Higher scores mean a better outcome."|4 months after the hands-on session.||||units on a scale||Inter-Quartile Range|Median
2554413|NCT02758119|Secondary|Score (on the Checklist) on the First Attempt During the hands-on Session|"Name: Checklist for performance score of SCA management This checklist was adapted from the 2015 resuscitation guidelines. Points were given for the actions performed correctly in sequence and in time(sequence score, 0 to 4),and for the quality of the chest compressions (compression score,0 to 8). The minimum passing score on this checklist was 11 out of 12 (min 0-max 12), with the absolute requirement to score the maximum 4 points on the sequence score.~Higher scores mean a better outcome."|The hands-on session takes place 8 days after the first pre-training when the serious game or the online course are played/watched twice, and one day after the second pre-training when they are played/watched once more||||units on a scale||Inter-Quartile Range|Median
2554414|NCT02758119|Secondary|Median Training Time Needed to Reach the Minimal Passing Score for a Simulated Out-of-hospital Cardiac Arrest Scenario Using a High-fidelity Simulator|Evaluation of skill retention.|4 months after the hands-on session.||||Minutes||Inter-Quartile Range|Median
2554415|NCT02758119|Primary|Median Training Time Needed to Reach the Minimal Passing Score for a Simulated Out-of-hospital Cardiac Arrest Scenario Using a High-fidelity Simulator at Day 8.|"Following the 2015 European Resuscitation Council guidelines, a checklist was developed for this study. This checklist allows the assessors to evaluate the participant's compliance with guidelines, and to determine if he/she needs to practice again on the scenario or if he/she reached the minimum passing score and can stop the training.~The quality of the chest compressions provided is recorded automatically through the ResusciAnne Skill Reporter Software (Laerdal, Norways), and is integrated in the checklist."|The hands-on session takes place 8 days after the first pre-training when the serious game or the online course are played/watched twice, and one day after the second pre-training when they are played/watched once more||||minutes||Inter-Quartile Range|Median
2554416|NCT02757963|Secondary|Summary of Agreement Between BPE/BPO and IPSS Screening Tools|Agreement between the IPSS and BPE/BPO tools had to utilize the screened population, as the evaluable population did not include any participants with IPSS <8 and BPE/BPO<3. All screened participants with IPSS and BPE/BPO results were utilized (2327 of the 2343 participants had IPSS and BPE/PO results). There were 16 participants (2343 minus 2327) in the screened population without IPSS and BPE/BPO results, and hence were not included in the calculation of the Kappa statistic. Kappa statistic values of <0 were characterized as no agreement, 0 to 0.20 as slight, 0.21 to 0.40 as fair, 0.41 to 0.60 as moderate, 0.61 to 0.80 as substantial, and 0.81 to 1.00 as almost perfect agreement. The 95% confidence interval for the Kappa statistic is based on the asymptotic standard error.|Day 1|All Screened Subjects Population comprised of all participants who were screened for eligibility. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2554417|NCT02757963|Secondary|Number of Men That Are Diagnosed With Probable BPH as Assessed by the GP Among Men With a Positive Result on the BPE/BPO, IPSS, BPE/BPO and IPSS, and BPE/BPO or IPSS Screening Tools|Diagnosis of probable BPH was based on GP assessment among men with a positive result on the BPE/BPO and/or IPSS screening tool. The BPE/BPO questionnaire consists of 3 questions each with a score from 0= never experienced to 5= almost always experienced. IPSS tool is used to assess the severity of LUTS symptoms with a score from 0= never experienced to 5= almost always experienced. Probable BPH is the presumptive diagnosis of urinary tract obstruction from an enlarged prostate based on clinical symptoms and findings where urinary symptoms are not apparently related to any other cause. Participants underwent GP assessment and lab result review by GP. Participants with PSA >=2 ng/mL were assessed for probable BPH. Proportion of participants was calculated by dividing number of participants with a positive result on the screening tool and diagnosis of probable BPH (Numerator) by number of participants with a positive result on the screening tool and a BPH assessment by GP (Denominator).|Up to 6 weeks|All Evaluable Subjects Population|||Participants|||Count of Participants
2554418|NCT02757963|Secondary|Number of Men That Are Confirmed to be at Risk for BPH Progression Based Upon Full Urologist Assessment Among Men With a Positive Result on the BPE/BPO, IPSS, BPE/BPO and IPSS, and BPE/BPO or IPSS Screening Tools and Serum PSA >=2 ng/mL|Confirmed risk for BPH was based on full urologist diagnostic testing with a positive result on the BPE/BPO and/or IPSS screening tool and probable GP BPH diagnosis. The BPE/BPO questionnaire consists of 3 questions each with a score from 0= never experienced to 5= almost always experienced. IPSS tool is used to assess the severity of LUTS symptoms with a score from 0= never experienced to 5= almost always experienced. Participants with probable BPH underwent full urologist diagnostic testing, which included review of medical history, symptoms and previous tests, physical examination, DRE. Participants with PSA >=2.0 ng/mL and other tests were considered as at risk for BPH. Proportion of participants was calculated by dividing number of participants with a positive result on the screening tool and diagnosis of BPH progression risk (Numerator) by number of participants with a positive result on the screening tool and a BPH progression risk assessment by the urologist (Denominator).|Up to 6 weeks|All Evaluable Subjects Population|||Participants|||Count of Participants
2554429|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and EoT in Treatment Satisfaction Visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale that asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) to 100 (Yes, completely).|Baseline and Weeks 4, 8, and 12|The analysis population consisted of the FAS. LOCF was used for EOT.|||units on a scale||Standard Error|Least Squares Mean
2554448|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, and Week 12 in Mean Number of Micturitions Per Day|Participants recorded micturitions in the e-diary during three days. The mean number of micturitions was calculated as the average number of times a participant recorded a micturition per day during the 3-day period. Only voluntary micturitions were counted and the episodes of incontinence were not included.|Baseline and Weeks 4, 8, and 12|The analysis population was the FAS.|||micturitions per day||Standard Error|Least Squares Mean
2554419|NCT02757963|Secondary|Number of Men That Are Confirmed to Have BPH Based on Full Urologist Assessment of Diagnostic Test Results Among Men With a Positive Result on the IPSS, BPE/BPO and IPSS, and BPE/BPO or IPSS Screening Tools and Serum PSA >=2 ng/mL|Confirmed diagnosis of BPH was based on full urologist diagnostic testing with a positive result on the IPSS, BPE/BPO and IPSS, BPE/BPO or IPSS screening tools and serum PSA >=2 ng/mL. The BPE/BPO questionnaire consists of three questions each with a score ranging from 0= never experienced to 5= almost always experienced. IPSS tool is used to assess the severity of LUTS symptoms with a score ranging from 0= never experienced to 5= almost always experienced. Participants with probable BPH underwent full urologist diagnostic testing, which included review of medical history, symptoms and previous tests, brief physical examination, DRE. Proportion of participants was calculated by dividing number of participants with a positive result on the screening tool and a diagnosis of BPH by the urologist (Numerator) by number of participants with a positive result on the screening tool and a BPH assessment by the urologist(Denominator).|Up to 6 weeks|All Evaluable Subjects Population|||Participants|||Count of Participants
2554420|NCT02757963|Primary|Number of Men With Confirmed Diagnosis of BPH|Confirmed diagnosis of BPH was based on full urologist diagnostic testing with a positive result on the BPE/BPO screening tool (score >=3) and serum PSA >=2 ng/mL. The BPE/BPO questionnaire consists of three questions each with a score ranging from 0= never experienced to 5= almost always experienced. Participants with probable BPH underwent full urologist diagnostic testing, which included review of medical history, symptoms and previous tests, brief physical examination, Digital rectal examination (DRE). Proportion of participants was calculated by dividing number of participants with a positive result on the BPE/BPO screening tool (Score >= 3) and a diagnosis of BPH by the urologist (Numerator) by number of participants with a positive result on the BPE/BPO screening tool (Score >= 3) and a BPH assessment by the urologist (Denominator). 95% confidence interval on the proportion was calculated by using the exact (Clopper-Pearson) method.|Up to 6 weeks|All Evaluable Subject Population comprised of all participants who meet the entry criteria, including a positive IPSS screening result (score >=8) and/or a positive BPE/BPO screening result (score >=3).|||Participants|||Count of Participants
2554421|NCT02757950|Secondary|Number of Subjects With Pregnancy-related AEs and Birth Outcomes Per Calendar Year|Pregnancy related AEs include: gestational diabetes, pregnancy-related hypertension, pre-eclampsia, eclampsia, HELLP Syndrome and pregnancy hemorrhage. Birth outcomes include: preterm birth and small for gestational age.|After week 27 of pregnancy|Analysis was performed on the Unexposed Cohort which included women pregnant before implementation of the maternal immunization program, who didn’t receive Refortrix, the study vaccine.|||Participants|||Count of Participants
2554422|NCT02757950|Secondary|Number of Subjects Reporting Cases of Congenital Anomalies in the Neonates|Congenital anomalies include morphological, functional, chromosomal or genetic anomalies, regardless of whether detected at birth or not, the foetus is delivered dead or alive, or defects are identified by prenatal ultrasound, amniocentesis or examination of the products of conception.|From week 27 of pregnancy up to birth|Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in.|||Participants|||Count of Participants
2554423|NCT02757950|Secondary|Number of Subjects Reporting Pregnancy-related Adverse Events (AEs) of Interest/Neonate-related Events up to Delivery|Pregnancy-related AEs of interest and neonate-related events are defined as: premature rupture of membranes, preterm premature rupture of membranes, premature uterine contraction, neonatal death, maternal death, still birth, neonatal hypoxic ischaemic encephalopathy.|After week 27 of pregnancy|Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in.|||Participants|||Count of Participants
2554424|NCT02757950|Primary|Number of Subjects With Pre-specified Neonate-related Outcomes, Resulting in Neonates Small for Their Gestational Age|Small for gestational age is defined as: Birth weight less than (<) 10% for infants of same gestational age and gender in same population.|After week 27 of pregnancy|Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in.|||Participants|||Count of Participants
2554425|NCT02757950|Primary|Number of Subjects With Pre-specified Neonate-related Outcomes Resulting in Preterm Birth|Preterm birth is defined as: Birth before 37 weeks of gestation.|From week 27 up to week 37 of pregnancy|Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in.|||Participants|||Count of Participants
2554426|NCT02757950|Primary|Number of Subjects Reporting Pregnancy Hemorrhage|"Pregnancy vaginal hemorrhage is defined as: excessive blood loss after delivery i.e. estimated blood loss in excess of 500 milliliters (ml) after vaginal delivery and estimated blood loss in excess of 1000 ml after Caesarean delivery. The other symptoms are higher than or equal to (≥) 10 percent (%) drop in hematocrit, need for blood transfusion, symptomatic hypotension, dizziness, pallor and oliguria.~Vaginal or intrauterine hemorrhage that encompasses antepartum (i.e. bleeding from the genital tract after 24 weeks of gestation), intrapartum, and postpartum bleeding (i.e. within 24 hours post-delivery).~A major obstetric hemorrhage is defined as blood loss from uterus or genital tract >1500 ml or a decrease."|After week 27 of pregnancy|Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in.|||Participants|||Count of Participants
2554427|NCT02757950|Primary|Number of Subjects Reporting Pregnancy-related Hypertension, Pre-eclampsia, Eclampsia, and HELLP Syndrome|"Pregnancy-related hypertension is defined as:~Blood pressure systolic higher than (>) 140 and/or diastolic > 90 millimetre of mercury (mmHg), documented in at least two separate measurements after 20 weeks of gestation, without proteinuria or other stigmata of pre-eclampsia, and returning to normal post-partum. Hypertension usually resolves by 12 weeks post-partum, included pre-eclampsia, eclampsia and haemolysis elevated liver enzymes low platelet (HELLP) Syndrome for this study."|After week 27 of pregnancy|Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in.|||Participants|||Count of Participants
2554428|NCT02757950|Primary|Number of Subjects Reporting Gestational Diabetes|Gestational diabetes was defined as: Onset or first recognition of abnormal glucose tolerance during pregnancy (the diagnosis is based on administration of glucose challenge test at 24-28 weeks of gestation). Includes Class A1: Euglycaemia achieved with diet and/or exercise and Class A2: Euglycaemia achieved with medication.|After week 27 of pregnancy|Analysis was performed on the Total Cohort (TC), which included all the subjects enrolled in the study with symptom sheets filled-in.|||Participants|||Count of Participants
2554430|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours|A nocturia episode was defined as waking at night one or more time to void (i.e., any voiding associated with sleep disturbance between the date/time the participant goes to bed with the intention to sleep until the date/time the participant gets up in the morning with the intention to stay awake). A night time episode of incontinence is not considered a nocturia episode. The mean number of nocturia episodes per day (24 hours) was calculated as the average number of times a participant recorded a nocturia episode per day during the 3-day micturition diary period.|Baseline and Weeks 4, 8, and 12|The analysis population was the full analysis set - nocturia (FAS-N), which consisted of all randomized participants who took at least 1 dose of double-blind study drug and reported 1 micturition at baseline and postbaseline in the 3-day e-diary.|||nocturia episodes per 24 hours||Standard Error|Least Squares Mean
2554431|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and EoT in Total Urgency and Frequency Score (TUFS)|The TUFS was calculated by adding the PPIUS scores of every void in a participant's 3-day diary, and dividing this by the number of days recorded in the diary. Due to a programming failure in the e-diary data for the number of pads used was not collected.|Baseline and Weeks 4, 8 and 12|The analysis population was the FAS.|||units on a scale||Standard Error|Least Squares Mean
2554432|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and EoT in Patient Perception of Bladder Condition (PPBC)|The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition.|Baseline and Weeks 4, 8, and 12|The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2554433|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and EoT in European Quality of Life in 5 Dimensions and 5 Levels (EQ-5D-5L Questionnaire) Utilities|The EQ-5D-5L is an international standardized non-disease specific generic instrument for describing and valuing health status. It has a multidimensional measure of health-related QoL, capable of being expressed as a single index value and specifically designed to complement other health status measures. The EQ-5D-5L has five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels (e.g., 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems/unable to perform the activity). In addition, it has a visual analog scale that elicits a self-rating by the respondent of his health status. Missing EoT values were imputed using LOCF method.|Baseline and Weeks 4, 8, and 12|The analysis population was the FAS.|||units on a scale||Standard Error|Mean
2554434|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Social Interaction Score|The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Social Interaction subscale ranges from 5 to 30. The Social Interaction score was calculated by adding the 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and Weeks 4, 8, and 12|The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2554435|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Sleep Score|The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Sleep subscale ranges from 5 to 30. The Sleep score was calculated by adding the 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and Weeks 4, 8 and 12|The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2554436|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Concern Score|The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Concern subscale ranges from 7 to 42. The Concern score was calculated by adding the 7 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and Weeks 4, 8, and 12|The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2554437|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and EoT in HRQL Subscale Coping Score|The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQL). The HRQL portion consists of 25 HRQL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. A higher score on OAB-q HRQL indicated a better response. The lowest and highest possible scores for the Coping subscale ranges from 8 to 48. The Coping score was calculated by adding the 8 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and Weeks 4, 8, and 12|The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2554447|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Volume Voided Per Micturition|The mean volume voided per micturition during 3 days of the 3-day micturition diary period.|Baseline and Weeks 4, 8, and 12|The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.|||mL per micturition||Standard Error|Least Squares Mean
2554438|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and EoT in Total Health Related Quality of Life (HRQL) Score|The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A higher score on OAB-q HRQL indicated a better response.|Baseline and Weeks 4, 8, and 12|The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2554439|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and EoT in Symptom Bother Score|Overactive bladder symptoms were assessed using the Symptom Bother Scale of the Overactive Bladder questionnaire (OAB-q). The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 questions, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). Lower scores on OAB-q symptom bother indicate a better response.|Baseline and Weeks 4, 8, and 12|The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2554440|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Incontinence Episodes Per Day|Urgency Incontinence was defined as the complaint of involuntary leakage accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes was calculated as the average number of times a participant recorded an urgency incontinence episode per day during the 3-day micturition diary period.|Baseline and Weeks 4, 8 and 12|The analysis population was the FAS-I. Missing values in the EoT were imputed using the LOCF method.|||urgency incontinence episodes per day||Standard Error|Least Squares Mean
2554441|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Quality of Life (QoL) Score|The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The lowest and highest possible score ranges from 0 to 6 (very pleased to terrible). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement.|Baseline and Weeks 4, 8, and 12|The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2554442|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, Week 12, and EoT in IPSS Subscale Storage Score|The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The subscale storage score is the sum of the responses to 3 storage symptoms questions (frequency, urgency, and nocturia). The lowest and highest possible scores range from 0 to 15 (mildly symptomatic to severely symptomatic). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement.|Baseline and Weeks 4, 8, and 12|The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2554443|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and EoT in IPSS Subscale Voiding Score|The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The subscale voiding score is the sum of the responses to 4 voiding symptoms questions (incomplete emptying, intermittency, weak stream, and straining). The lowest and highest possible scores range from 0 to 20 (mildly symptomatic to severely symptomatic). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement.|Baseline and Weeks 4, 8, and 12|The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2554444|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and EoT in International Prostate Symptom Score (IPSS) Total Score|The International Prostate Symptom Score (IPSS) consists of 7 questions concerning urinary symptoms and 1 question concerning quality of life (QoL) with total score and subscores (voiding, storage and QoL). The IPSS total score classification ranges from mild (0 to 7) to moderate (8 to 19) or severe (20 to 35). Higher IPSS scored indicated more severe symptoms.|Baseline and Weeks 4, 8, and 12|The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2554445|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per Day|Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per day was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period.|Baseline and Weeks 4, 8, and 12|The analysis population was the FAS. Missing values in the EoT were imputed using the LOCF method.|||urgency episodes per day||Standard Error|Least Squares Mean
2554446|NCT02757768|Secondary|Change From Baseline to Week 4, Week 8, Week 12 and EoT in Mean Number of Incontinence Episodes Per Day|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated as the average number of times a participant recorded an incontinence episode per day during the 3-day micturition diary period.|Baseline and Weeks 4, 8, and 12|The analysis population was the full analysis set - incontinence (FAS-I), which consisted of all randomized participants who took at least 1 dose of double-blind study drug and reported 1 micturition at baseline and postbaseline in the 3-day e-diary. Missing values in the EoT were imputed using the LOCF method.|||incontinence episodes per day||Standard Error|Least Squares Mean
2554449|NCT02757768|Primary|Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per Day|Participants recorded micturitions in the e-diary during three days. The mean number of micturitions was calculated as the average number of times a participant recorded a micturition per day during the 3-day period. Only voluntary micturitions were counted and the episodes of incontinence were not included.|Baseline and Week 12|The analysis population was the full analysis set (FAS), which consisted of all randomized participants who took at least 1 dose of double-blind study drug, reported at least 1 baseline micturition recorded in the 3-day e-diary and at least 1 postbaseline micturition. Last observation carried forward (LOCF) was used for missing values in the EoT.|||micturitions per day||Standard Error|Least Squares Mean
2554450|NCT02757625|Other Pre-specified|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities|Criteria for clinically significant electrocardiogram abnormalities was based on Investigators decision.|Baseline up to 28 days after end of study drug dosing (Day 56)|Safety analysis set included all participants who received at least one dose of the investigational product. Here “N” signifies number of participants who were evaluable for this specified outcome measure.|||Participants|||Count of Participants
2554451|NCT02757625|Other Pre-specified|Incidence of Potential Withdrawal Symptoms|The potential withdrawal symptoms were defined as AEs that occurred or worsened after end of administration of dexmedetomidine. It included bradycardia, abdominal discomfort, abdominal pain, dry mouth, nausea, vomiting, injection site pain, pyrexia, body temperature increased, electrocardiogram QT prolonged, neuralgia, agitation, atelectasis, oropharyngeal pain and hypotension. Incidence of potential withdrawal symptoms was reported in terms of number of participants who had any of the mentioned withdrawal symptoms.|Baseline up to 28 days after end of study drug dosing (Day 56)|Safety analysis set included all participants who received at least one dose of the investigational product.|||Participants|||Count of Participants
2554452|NCT02757625|Other Pre-specified|Total Input/Output Fluid Volume|Total input fluid volume was defined as the quantity of total fluids administered and total output fluid volume was defined as the quantity of total fluids excreted or lost during the specified evaluation period.|Baseline up to 28 days after end of study drug dosing (Day 56)|Safety analysis set included all participants who received at least one dose of the investigational product. Here “N” signifies number of participants who were evaluable for this specified outcome measure.|||milliliters (mL)||Standard Deviation|Mean
2554453|NCT02757625|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities|Criteria for abnormality: hemoglobin, hematocrit and red blood cell count <0.8*lower limit of normal(LLN); platelet <0.5*LLN; >1.75*upper limit of normal(ULN); white blood cell count <0.6*LLN; >1.5*ULN; lymphocytes, neutrophils and stab cells <0.8*LLN; >1.2*ULN; eosinophils, basophils and monocytes >1.2*ULN; total bilirubin >1.5*ULN; aspartate aminotransferase, alanine aminotransferase and gamma guanosine triphosphate and alkaline phosphatase >3*ULN; total protein and albumin <0.8*LLN; >1.2*ULN; glucose <0.6*LLN; >1.5*ULN; blood urea nitrogen and creatinine >1.3*ULN; uric acid >1.2*ULN; sodium <0.95*LLN; >1.05*ULN, potassium, calcium and magnesium <0.9*LLN; >1.1*ULN; phosphate <0.8*LLN; >1.2*ULN.|Baseline up to 28 days after end of study drug dosing (Day 56)|Safety analysis set included all participants who received at least one dose of the investigational product. Here “N” signifies number of participants who were evaluable for this specified outcome measure.|||Participants|||Count of Participants
2554454|NCT02757625|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included: systolic and diastolic blood pressure, heart rate, respiratory rate, percutaneous oxygen saturation, end-tidal carbon dioxide, core body temperature and body weight. Criteria for clinically significant vital signs abnormalities was based on Investigators decision.|Baseline up to 28 days after end of study drug dosing (Day 56)|Safety analysis set included all participants who received at least one dose of the investigational product.|||Participants|||Count of Participants
2554455|NCT02757625|Other Pre-specified|Number of Participants With Treatment- Emergent Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to up to 28 days after end of study drug dosing (up to 56 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both non-serious adverse events (AEs) and SAEs.|Baseline up to 28 days after end of study drug dosing (up to 56 days)|Safety analysis set included all participants who received at least one dose of the investigational product.|||Participants|||Count of Participants
2554456|NCT02757625|Secondary|Median Time to Conclusion of Mechanical Ventilation|Time to conclusion of mechanical ventilation was defined as time duration from start of study drug administration until the end of mechanical ventilation.|Baseline (start of study drug dosing) until end of mechanical ventilation (up to 28 days)|FAS: all participants who received at least one dose of the investigational product.|||hours||Full Range|Median
2554457|NCT02757625|Secondary|Body Weight Adjusted Total Amount of Rescue Analgesic Taken After Extubation|Total amount of rescue analgesic (fentanyl) administered by the participants after extubation. Dose was adjusted for body weight (mcg divided by kg).|From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)|Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here “N” signifies number of participants who were evaluable for this specified outcome measure.|||mcg/kg||Standard Deviation|Mean
2554458|NCT02757625|Secondary|Total Amount of Rescue Analgesic Taken After Extubation|Total amount of rescue analgesic (fentanyl) administered by the participants after extubation.|From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)|Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here “N” signifies number of participants who were evaluable for this specified outcome measure.|||mcg||Standard Deviation|Mean
2554583|NCT02756689|Secondary|Number of Neonates With a 5-minute Apgar Score Less Than 7|Apgar scores are assigned to all births. These are universally performed and assigned in the United States. The scoring system is between 0-10. 0 is the minimum score and 10 is the maximum. Lower scores are worse than higher scores.|Assessed at time of delivery up to 5-minutes post-delivery.||||Neonates|||Number
2554459|NCT02757625|Secondary|Body Weight Adjusted Total Amount of Rescue Sedative Taken After Extubation|Total amount of rescue sedative (midazolam) administered by the participants after extubation. Dose was adjusted for body weight (mg divided by kg).|From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)|Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here “N” signifies number of participants who were evaluable for this specified outcome measure.|||mg/kg||Standard Deviation|Mean
2554460|NCT02757625|Secondary|Total Amount of Rescue Sedative Taken After Extubation|Total amount of rescue sedative (Midazolam) administered by the participants after extubation.|From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)|Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period). Here “N” signifies number of participants who were evaluable for this specified outcome measure.|||mg||Standard Deviation|Mean
2554461|NCT02757625|Secondary|Percentage of Maintenance Duration of Target Sedation Level After Extubation|Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was −1 to 0, where higher score indicated more responsive.|From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)|FAS included all participants who received at least one dose of the study drug. Here “N” signifies number of participants who were evaluable for this specified outcome measure.|||Percentage of time||Standard Deviation|Mean
2554462|NCT02757625|Secondary|Duration of Maintenance of Target Sedation Level After Extubation|Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation (removal of endotracheal tube), the target sedation depth was −1 to 0, where higher score indicated more responsive.|From extubation till end of treatment (6 hours after start of study drug dosing up to 28 days)|FAS included all participants who received at least one dose of the study drug. Here “N” signifies number of participants who were evaluable for this specified outcome measure.|||hours||Standard Deviation|Mean
2554463|NCT02757625|Secondary|Percentage of Maintenance Duration of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation|Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was −1 to 0, where higher score indicated more responsive.|After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)|Participants from FAS population whose period of dosing of investigational product exceeded 24 hours.|||percentage of time||Standard Deviation|Mean
2554464|NCT02757625|Secondary|Duration of Maintenance of Target Sedation Level After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation|Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more stability and after extubation (removal of endotracheal tube), the target sedation depth was −1 to 0, where higher score indicated more stability.|After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)|Participants from FAS population whose period of dosing of investigational product exceeded 24 hours.|||hours||Standard Deviation|Mean
2554465|NCT02757625|Secondary|Body Weight Adjusted Total Amount of Rescue Analgesic Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation|Total amount of rescue analgesic (fentanyl) after 24 hours of dosing of study drug. Dose was adjusted for body weight (mcg divided by kg).|After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)|Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).||||||
2554466|NCT02757625|Secondary|Total Amount of Rescue Analgesic Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation|Total amount of rescue analgesic (Fentanyl) administered by the participants after 24 hours of dosing of study drug.|After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)|Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).||||||
2554467|NCT02757625|Secondary|Body Weight Adjusted Total Amount of Rescue Sedative Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation|Total amount of rescue sedative (midazolam) required after 24 hours of dosing of study drug. Dose was adjusted for body weight (mg divided by kg).|After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)|Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue sedative in the specified evaluation period).||||||
2554468|NCT02757625|Secondary|Total Amount of Rescue Sedative Taken After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation|Total amount of rescue sedative (midazolam) administered after 24 hours of dosing of study drug.|After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)|Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).||||||
2554469|NCT02757625|Secondary|Percentage of Participants Who Did Not Require Dosing of a Rescue Analgesic After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation|Percentage of participants whose period of dosing of the investigational product exceeded 24 hours and who did not received rescue analgesic (Fentanyl) based on the investigator's judgement were reported.|After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)|Participants from FAS population whose period of dosing of investigational product exceeded 24 hours.|||percentage of participants||95% Confidence Interval|Number
2554470|NCT02757625|Secondary|Percentage of Participants Who Did Not Use a Rescue Sedative After 24 Hours of Dosing of Study Drug Till End of Mechanical Ventilation|Percentage of participants whose period of dosing of the investigational product exceeded 24 hours and who did not received rescue medication for Sedation (Midazolam) based on the data of investigator's judgement and SBS (which was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation [placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs], the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation [removal of endotracheal tube], the target sedation depth was −1 to 0, where higher score indicated more responsive) were reported.|After 24 hours of study drug dosing till end of mechanical ventilation (up to 28 days)|Participants from FAS population whose period of dosing of investigational product exceeded 24 hours.|||percentage of participants||95% Confidence Interval|Number
2554471|NCT02757625|Secondary|Percentage of Maintenance Duration of Target Sedation Level Within 24 Hours of Dosing of Study Drug|Percentage of time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the state behavioral scale (SBS). SBS is a sedation assessment instrument and it's score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= non-responsive. During intubation the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation, the target sedation depth was −1 to 0, where higher score indicated more responsive.|From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)|FAS included all participants who received at least one dose of the study drug. Here “N” signifies number of participants who were evaluable for this specified outcome measure.|||percentage of time||Standard Deviation|Mean
2554472|NCT02757625|Secondary|Duration of Maintenance of Target Sedation Level Within 24 Hours of Dosing of Study Drug|Time duration for which the target sedation level was maintained during the specified evaluation period within participants was reported. Target sedation level was analyzed by target sedation scores by using the SBS. SBS was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation (placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs), the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation (removal of endotracheal tube), the target sedation depth was −1 to 0, where higher score indicated more responsive.|From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)|FAS included all participants who received at least one dose of the study drug. Here “N” signifies number of participants who were evaluable for this specified outcome measure.|||hours||Standard Deviation|Mean
2554473|NCT02757625|Secondary|Body Weight Adjusted Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug|Total amount of rescue analgesic (fentanyl) within 24 Hours of dosing of study drug. Dose was adjusted for body weight (mcg divided by kg).|From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)|Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period). Here “N” signifies number of participants who were evaluable for this specified outcome measure.|||mcg/kg||Standard Deviation|Mean
2554474|NCT02757625|Secondary|Total Amount of Rescue Analgesic Taken Within 24 Hours of Dosing of Study Drug|Total amount of rescue sedative (fentanyl) required Within 24 Hours of dosing of study drug.|From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)|Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period). Here “N” signifies number of participants who were evaluable for this specified outcome measure.|||micrograms||Standard Deviation|Mean
2554475|NCT02757625|Secondary|Body Weight Adjusted Total Amount (Per Kg) of Rescue Sedative Taken Within 24 Hours of Dosing of Study Drug|Total amount of rescue sedative (midazolam) required within 24 hours of dosing of study drug. Dose was adjusted for body weight (mg divided by kg).|From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)|Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).|||mg/kg||Standard Deviation|Mean
2554584|NCT02756689|Secondary|Number of Participants With Readmission Within 30 Days||Assessed from time of discharge until 30 days post-discharge.||||Participants|||Count of Participants
2554476|NCT02757625|Secondary|Total Amount of Rescue Sedative Administered Within 24 Hours of Dosing of Study Drug|Total amount of rescue sedative (midazolam) administered Within 24 Hours of dosing of study drug.|From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)|Analysis was performed on only rescued participants (defined as all participants who received any amount of rescue medication in the specified evaluation period).|||milligrams (mg)||Standard Deviation|Mean
2554477|NCT02757625|Secondary|Percentage of Participants Who Did Not Require Administration of a Rescue Analgesic Within 24 Hours of Dosing of Study Drug|Percentage of participants who did not require administration of a rescue analgesic (Fentanyl) in addition to administration of the study drug based on investigator's judgement were reported.|From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)|FAS included all participants who received at least one dose of the study drug.|||percentage of participants||95% Confidence Interval|Number
2554478|NCT02757625|Primary|Percentage of Participants Who Did Not Require a Rescue Sedative Within 24 Hours of Dosing of Study Drug|Percentage of participants who did not require rescue medication for Sedation (Midazolam) based on the data of investigator's judgement and State Behavioral Scale (SBS) (which was a sedation assessment instrument for intubated participants and its score ranges from 2 to -3, where 2= agitated, 1= restless and difficult to calm, 0= awake and able to calm, -1= responsive to gentle touch or voice, -2= responsive to noxious stimuli and -3= unresponsive. During intubation [placement of a flexible plastic tube into the trachea to maintain an open airway or to serve as a conduit through which to administer certain drugs], the target sedation depth by SBS was -2 to 0, where higher score indicated more responsive and after extubation [removal of endotracheal tube], the target sedation depth was −1 to 0, where higher score indicated more responsive) were reported.|From start of study drug administration on Day 1 up to 24 hours of study drug dosing or at the conclusion of mechanical ventilation or the end of study drug administration, whichever is earliest (up to maximum of 28 days)|FAS included all participants who received at least one dose of the study drug.|||percentage of participants||95% Confidence Interval|Number
2554479|NCT02757547|Primary|Suppression of Seizure Frequency|The primary outcome was determined to be measured by the reduction in seizure frequency compared to baseline.|Placebo compared to Active|The study was initiated by Electrical Geodesics, Inc. which was acquired by Philips in July of 2017. At the time of the acquisition it was decided not to pursue Magnetic Stimulation as a product and as such the study was terminated.||||||
2554480|NCT02757521|Other Pre-specified|Scale for Suicidal Ideation (SSI) to Assesses for Emergence of Suicidal Thinking||up to 1 week|||||||
2554481|NCT02757521|Other Pre-specified|Brief Psychiatric Rating Scale (BPRS) to Assess Psychotic or Hallucinogenic Behavior||up to 1 week|||||||
2554482|NCT02757521|Other Pre-specified|Clinician Administered Dissociative States Scale (CADSS) for Emergence of Disassociation||up to 1week|||||||
2554483|NCT02757521|Other Pre-specified|Quick Inventory of Depressive Symptomatology- Self Report (QIDS -SR) Patient-rated Depression Measure||up to 1 week|||||||
2554484|NCT02757521|Other Pre-specified|Profile of Mood States (POMS) Short Form to Assess for Rapid/Instantaneous Changes in Mood/Affect||up to 1 week|||||||
2554485|NCT02757521|Secondary|Young Mania Rating Scale (YMRS) to Assess Emergence of Mania/Hypomania|Young Mania Rating Scale (YMRS) to assess emergence of mania/hypomania (patients with YMRS scores > 12 will be removed from the trial and recommended for follow up treatment per Psychiatry P.I., i.e., nitrous oxide treatments discontinued)|up to 1 week|||||||
2554486|NCT02757521|Secondary|Hamilton Depression Rating Scale-17 Item (Ham-D17)||up to1week|||||||
2554487|NCT02757521|Primary|Change in MADRS (Montgomery Asberg Depression Rating Scale)|Change in depressive symptoms on MADRS scale between baseline and day 7 follow up|up to 1 week|Difficulty with recruitment caused study sponsor to end trial after designated award length; no analysis done||||||
2554488|NCT02757430|Secondary|Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement|Count and percentage of subjects where the AutoMark feature was easy to use|during procedure|373 procedures used AutoMark|||Participants|||Count of Participants
2554489|NCT02757430|Secondary|Clinical Utility and Ease of Use of the Automated Radiofrequency Marker Placement|Count and percentage of subjects where the AutoMark feature assisted in identifying gaps in lesion lines|during procedure|117 subjects had gaps identified in the lesion line|||Participants|||Count of Participants
2554490|NCT02757430|Secondary|EnSite Precision™ Cardiac Mapping System Assessment|Overall procedure time summarized using mean and standard deviation|during procedure|501 subjects had procedure time available|||mins||Standard Deviation|Mean
2554491|NCT02757430|Secondary|EnSite Precision™ Cardiac Mapping System Assessment|Count and percentage of subjects in whom the mapping system was reported to be excellent, very good, good, poor and N/A|during procedure||||Participants|||Count of Participants
2554492|NCT02757430|Primary|Assessment of the EnSite Precision™ Software V2.0 in Terms of Unrecoverable Shifts|summarizing the count and percentage of patients with unrecoverable shifts|during procedure|46 procedures with system not stable throughout the procedure|||Participants|||Count of Participants
2554493|NCT02757430|Primary|Assessment of the EnSite Precision™ Software V2.0 in Terms of System Stability|summarizing the count and percentage of patients with overall system stability|during procedure||||Participants|||Count of Participants
2554494|NCT02757430|Primary|Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters|mapping points collected and used will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate)|during procedure|606 total maps with mapping points used available were created in 421 subjects.|||mapping points used|maps|Standard Deviation|Mean
2554495|NCT02757430|Primary|Point Density Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters|mapping points collected and used will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate)|during procedure|606 total maps with mapping points collected available were created in 421 subjects.|||mapping points collected|maps|Standard Deviation|Mean
2554497|NCT02757430|Primary|Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With AutoMap Module Mapping|mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: AutoMap module|during procedure|526 total AutoMap Module maps were created.|||min|AutoMap Module Maps|Standard Deviation|Mean
2554498|NCT02757430|Primary|Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters With Manual Mapping|mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: Manual|during procedure|62 total Manual maps were created.|||min|manual maps|Standard Deviation|Mean
2554499|NCT02757430|Primary|Mapping Time Associated With (re-)Mapping One or Multiple Arrhythmias in a Single Subject With a Variety of Catheters|mapping time will be summarized (using mean and standard deviation across arrhythmia types, and for each type of arrhythmia as appropriate) for the following modules: Manual AutoMap™ TurboMap™|during procedure|603 total maps were created in 421 subjects.|||min|maps|Standard Deviation|Mean
2554500|NCT02757430|Primary|Assessment of the EnSite Precision™ Software V2.0 in Terms of Geometry Accuracy|summarizing the count and percentage of patients with accurate geometry|during procedure||||Participants|||Count of Participants
2554501|NCT02757352|Secondary|Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss)|PK trough serum concentration samples were collected at steady state (Ctrough ss)|Week 52|All randomized participants who had evaluable PK data.|||microgram/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2554502|NCT02757352|Secondary|Number of Participants With Treatment Emergent (TE) Anti-Ixekizumab Antibodies|A treatment-emergent positive anti-drug antibody (TE-ADA+) participant will be defined as a 4-fold increase over a positive baseline antibody titer (Tier 3); or for a negative baseline titer, a participant with an increase from the baseline to a level of ≥ 1:10.|Week 52|All randomized participant who received at least one dose of ixekizumab during the study and had an evaluable baseline sample and at least 1 evaluable post baseline sample.|||Participants|||Count of Participants
2554503|NCT02757352|Secondary|Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score|ASAS-NSAID score is used to present the NSAID intake by considering the type of NSAID, the total dose, & the number of days taking NSAID during a period of interest (PI). For NSAID equivalent scoring system, range is from 0 to 100, the higher the score, the greater the NSAID intake. ASAS-NSAID score= (equivalent NSAID score) x (days of intake during PI) x (days per week)/(PI in days).|Baseline, Week 52|All randomized participants who had NSAID (including COX-2 Inhibitor) intake at Baseline. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||score on a scale||Standard Deviation|Mean
2554504|NCT02757352|Secondary|Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores|The WPAI-SpA consists of 6 questions to determine employment status, hours missed from work because of SpA, hours missed from work for other reasons, hours actually worked, the degree to which SpA affected work productivity while at work, and the degree to which SpA affected activities outside of work. The WPAI-SpA has been validated in the rad-axSpA patient population. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. The computed percentage range for each sub-scale was from 0-100, with higher scores indicating greater impairment and less productivity. LS Mean was derived from ANCOVA with treatment, geographic region, screening MRI/CRP status and baseline value.|Baseline, Week 52|All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included. Missing data were imputed using the modified baseline observation carried forward (mBOCF).|||score on a scale||Standard Error|Least Squares Mean
2554505|NCT02757352|Secondary|Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)|"Jenkins Sleep Evaluation Questionnaire (JSEQ) is a 4 item scale designed to estimate sleep problems in clinical research. The JSEQ assesses the frequency of sleep disturbance in 4 categories: 1) trouble falling asleep, 2) waking up several times during the night, 3) having trouble staying asleep (including waking up far too early), and 4) waking up after the usual amount of sleep feeling tired and worn out. Patients report the numbers of days they experience each of these problems in the past month on a 6 point Likert Scale ranging from 0 = no days to 5 = 22-30 days. The total JSEQ score ranges from 0 to 20, with higher scores indicating greater sleep disturbance. LS Mean was derived from using MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 52|All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||units on a scale||Standard Error|Least Squares Mean
2554506|NCT02757352|Secondary|Change From Baseline in ASAS Health Index (ASAS HI)|"ASAS-HI is a disease-specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17-item instrument has scores ranging from 0 (good health) to 17 (poor health). Each item consists of one question that the participant needs to respond to with either I agree (score of 1) or I do not agree (score of 0). A score of 1 is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index. LS Mean was derived MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 52|All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||score on a scale||Standard Error|Least Squares Mean
2554585|NCT02756689|Secondary|Number of Participants With Endometritis||Assessed from delivery until 30 days post-discharge.||||Participants|||Count of Participants
2554586|NCT02756689|Secondary|Postpartum Hemorrhage||Assessed at delivery.||||Participants|||Count of Participants
2554587|NCT02756689|Secondary|Number of Participants With an Operative Vaginal Delivery||Assessed at delivery.||||Participants|||Count of Participants
2554588|NCT02756689|Secondary|Number of Participants Who Had a Cesarean Delivery||Assessed from baseline to delivery.||||Participants|||Count of Participants
2554507|NCT02757352|Secondary|Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score|"The Fatigue Severity NRS is a participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing no fatigue and 10 representing as bad as you can imagine. Participants rate their fatigue (feeling tired or worn out) by circling the one number that describes their worst level of fatigue during the previous 24 hours. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 52|All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||score on a scale||Standard Error|Least Squares Mean
2554508|NCT02757352|Secondary|Number of Participants With Anterior Uveitis|Number of participants with anterior uveitis. Anterior uveitis is an inflammation of the middle layer of the eye which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body.|Baseline through Week 52|All randomized participants regardless of history of anterior uveitis. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||Participants|||Count of Participants
2554509|NCT02757352|Secondary|Change From Baseline in Severity of Peripheral Arthritis by Tender (TJC) and Swollen Joint Count (SJC) Scores of 44 Joints|The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the participants body). The 46 joints are assessed and classified as tender or not tender. Sum of all joints checked to be tender/painful divided by number of evaluable joints which is multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). Swollen joint count SJC was determined by examination of 44 joints (22 joints on each side of the participants body). The joints are classified as swollen or not swollen. Sum of all joints checked to be swollen divided by number of evaluable joints which is multiplied by 44 to obtain SJC score. Score ranges from 0 (not swollen) to 44 (all joints swollen). LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status and baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.|Baseline, Week 52|All randomized participants with baseline TJC>0 for the TJC analysis. All randomized participants with baseline SJC>0 for the SJC analysis. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||joint counts||Standard Error|Least Squares Mean
2554510|NCT02757352|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)|"Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) is an index used to measure the severity of enthesitis. The MASES assesses 13 sites for enthesitis using a score of 0 for no activity or 1 for activity. Sites assessed included costochondral 1 (right/left [R/L]), costochondral 7 (R/L), spinal iliaca anterior superior (R/L), crista iliaca (R/L), spina iliaca posterior (R/L), processus spinosus L5, and achilles tendon proximal insertion (R/L). The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis. LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 52|All randomized participants with baseline Mases score > 0. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||score on a scale||Standard Error|Least Squares Mean
2554511|NCT02757352|Secondary|Change From Baseline in Occiput to Wall Distance|The participant is to make a maximum effort to touch the head against the wall when standing with heels and back against the wall (occiput). Then the distance from occiput to wall is measured. Two tries will be recorded. The better (smaller) measurement of 2 tries (in centimeters) will be used for analyses. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.|Baseline, Week 52|All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||cm||Standard Error|Least Squares Mean
2554512|NCT02757352|Secondary|Change From Baseline in Chest Expansion|While participants have their hands resting on or behind the head, the assessor has measured the chest's encircled length by centimeter at the fourth intercostal level anteriorly. The difference between maximal inspiration and expiration in centimeters was recorded. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.|Baseline, Week 52|All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||centimeter (cm)||Standard Error|Least Squares Mean
2554513|NCT02757352|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)|Bath Ankylosing Spondylitis Metrology Index (BASMI) is a combined index comprising the following 5 clinical measurements of spinal mobility in participants with axSpA: 1) Lateral spinal flexion 2) Tragus-to-wall distance 3) Lumbar flexion (modified Schrober) 4) Maximal intermalleolar distance, and 5) Cervical rotation. The BASMI includes these 5 measurements that were each scaled to a score of 0 to 10 depending on the result of the assessment (BASMI linear function). The average score of the 5 assessments gives the BASMI linear result. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.|Baseline, Week 52|All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||score on a scale||Standard Error|Least Squares Mean
2554549|NCT02756832|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time|The change in the value of fasting plasma glucose value collected at Months 3 and 6 relative to baseline. Target FPG depended on the defined individual targets of glycemic control by HbA1c level ≤6.5 to 8.0 mmol/l. A negative change from Baseline indicates improvement.|Baseline, Months 3 and 6|All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.|||mmol/l||Standard Deviation|Mean
2554514|NCT02757352|Secondary|Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)|High-sensitivity C-reactive protein (hs-CRP) was the measure of acute phase reactant and was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.|Baseline, Week 52|All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||milligram/liter (mg/L)||Standard Error|Least Squares Mean
2554515|NCT02757352|Secondary|Percentage of Participants Achieving ASDAS Inactive Disease|ASDAS is a composite index to assess disease activity in axSpA. ASDAS Inactive Disease is defined as a score of less than (<)1.3. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.|Week 52|All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included. Missing data was imputed using the NRI method.|||percentage of participants|||Number
2554516|NCT02757352|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)|BASFI is a participant-reported assessment that establishes a participant's functional baseline and subsequent response to treatment. Participants were asked to rate the difficulty associated with 10 individual basic functional activities. Participant responded to each question using a NRS scale (range 0 to 10), with a higher score indicating worse functioning. The participant's final BASFI score is the mean of the 10 item scores with the minimum value of 0 and a possible maximum value of 10, with a higher score indicating worse function. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.|Baseline, Week 52|All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||score on a scale||Standard Error|Least Squares Mean
2554517|NCT02757352|Secondary|Change From Baseline in SPARCC Enthesitis Score|"The SPARCC enthesitis is an index used to measure the severity of enthesitis. The SPARCC assesses 16 sites for enthesitis using a score of 0 for no activity or 1 for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors."|Baseline, Week 52|All randomized participants with a baseline SPARCC score >0. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||score on a scale||Standard Error|Least Squares Mean
2554518|NCT02757352|Secondary|Change From Baseline in Magnetic Resonance Imaging (MRI) of the Sacroiliac Joint (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score|Both left and right SIJ are scored for bone marrow edema. Each side has 6 slices and each slice has 6 scoring units, and each scoring unit has a score of 0 or 1. Total SIJ SPARCC scores can range from 0 to 72 with higher scores reflecting worse disease. LS Mean was derived from ANCOVA model with treatment, geographic region, screening MRI/CRP status and baseline value as fixed factors.|Baseline, Week 16|All randomized participants with baseline and Week 16 SPARCC score. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||score on a scale||Standard Error|Least Squares Mean
2554519|NCT02757352|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to axial spondyloarthritis (axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.|Baseline, Week 52|All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||score on a scale||Standard Error|Least Squares Mean
2554520|NCT02757352|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to axial spondyloarthritis (axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.|Baseline, Week 16|All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||score on a scale||Standard Error|Least Squares Mean
2554589|NCT02756689|Secondary|Number of Participants With Neonates With Shoulder Dystocia||Assessed at delivery.||||Participants|||Count of Participants
2554590|NCT02756689|Secondary|Number of Participants With Meconium-stained Fluid||Assessed from baseline to delivery.||||Participants|||Count of Participants
2554521|NCT02757352|Secondary|Percentage of Participants Achieving ASDAS Low Disease Activity|ASDAS is a composite index to assess disease activity in axSpA. ASDAS low disease activity is defined as a score of <2.1. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.|Week 52|All randomized participants with baseline ASDAS <2.1. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included. Missing data was imputed using the NRI method.|||percentage of participants|||Number
2554522|NCT02757352|Secondary|Percentage of Participants Achieving ASDAS Low Disease Activity|ASDAS is a composite index to assess disease activity in axSpA. ASDAS low disease activity is defined as a score of <2.1. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.|Week 16|All randomized participants with baseline ASDAS <2.1. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included. Missing data was imputed using the NRI method.|||percentage of participants|||Number
2554523|NCT02757352|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score|The medical outcomes study 36-item short-form health survey (SF-36) SF-36 PCS are summarized using the t-scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.|Baseline, Week 52|All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||score on a scale||Standard Error|Least Squares Mean
2554524|NCT02757352|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score|The SF-36 is a 36-item patient-administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The Physical Component Summary score ranges from 0 to 100; higher scores indicate better levels of function and/or better health. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.|Baseline, Week 16|All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||score on a scale||Standard Error|Least Squares Mean
2554525|NCT02757352|Secondary|Number of Participants Without Clinically Meaningful Changes in Background Therapy|Number of participants without changes in background therapy while on originally randomized treatment.|Baseline through Week 52|All randomized participants. Additional analysis not performed due to small number of participants with changes in background therapy and complete overlap with switch to open-label ixekizumab.|||Participants|||Count of Participants
2554526|NCT02757352|Secondary|Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)|ASDAS is a composite index to assess disease activity in axSpA. ASDAS parameters used (with CRP as acute phase reactant) are: 1 )Total back pain 2) Patient global 3) Peripheral pain/swelling 4) Duration of morning stiffness 5) CRP in mg/L: ASDAScrp is calculated with the following equation: 0.121 × total back pain + 0.110 × patient global + 0.073 × peripheral pain/swelling + 0.058 × duration of morning stiffness + 0.579 × Ln(CRP+1). CRP is in milligram/liter (mg/L), the range of other variables is from 0 to 10. Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.|Baseline, Week 52|All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||score on a scale||Standard Error|Least Squares Mean
2554527|NCT02757352|Secondary|Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)|ASDAS is a composite index to assess disease activity in axial spondyloarthritis (axSpA). ASDAS parameters used with (C-reactive protein [CRP] as acute phase reactant) are: 1) Total back pain 2) Patient global 3) Peripheral pain/swelling, duration of morning stiffness 4) CRP in mg/L: ASDAScrp is calculated with the equation: 0.121 × total back pain + 0.110×patient global + 0.073 × peripheral pain/swelling + 0.058 × duration of morning stiffness + 0.579 × Ln(CRP+1). CRP is in milligram/liter (mg/L), the range of other variables is from 0 to 10. Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. Least squares mean (LS Mean) was derived from mixed models repeated measure analysis (MMRM) with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.|Baseline, Week 16|All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.|||score on a scale||Standard Error|Least Squares Mean
2554550|NCT02756832|Secondary|Percentage of Participants With Marked Hyperglycemia at Month 3|Marked hyperglycemia is defined as fasting plasma glucose (FPG) higher than or equal to 11 mmol/L.|Month 3|All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study.|||percentage of participants||95% Confidence Interval|Number
2554528|NCT02757352|Primary|Percentage of Participants Achieving an ASAS40 Response|ASAS40 is defined as a greater than or equal to (≥)40% improvement and an absolute improvement from baseline of ≥2 units (ranges 0 to 10) in at least 3 of the 4 domains (Patient Global, Spinal Pain, Function, and Inflammation), without any worsening in the remaining domain. 1) Patient Global: How active was your spondylitis during the last week? score ranges 0 (not active) to 10 (very active). 2) Spinal Pain: How much spinal pain due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3) Bath Ankylosing Spondylitis Functional Index: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Responses were captured using numeric rating scale (NRS) (ranges 0 to 10) with a higher score of worse function. 4) Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) question 5 and 6 (mean of intensity, duration of stiffness). Score ranges (0 (non) to 10 (very severe).|Week 52|All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included. Missing data was imputed using the nonresponder imputation (NRI) method.|||percentage of participants|||Number
2554529|NCT02757352|Primary|Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response|ASAS40 is defined as a greater than or equal to (≥)40% improvement and an absolute improvement from baseline of ≥2 units (ranges 0 to 10) in at least 3 of the 4 domains (Patient Global, Spinal Pain, Function, and Inflammation), without any worsening in the remaining domain. 1) Patient Global: How active was your spondylitis during the last week? score ranges 0 (not active) to 10 (very active). 2) Spinal Pain: How much spinal pain due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3) Bath Ankylosing Spondylitis Functional Index: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Responses were captured using numeric rating scale (NRS) (ranges 0 to 10) with a higher score of worse function. 4) Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) question 5 and 6 (mean of intensity, duration of stiffness). Score ranges (0 (non) to 10 (very severe).|Week 16|All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included. Missing data was imputed using the nonresponder imputation (NRI) method.|||percentage of participants|||Number
2554530|NCT02757105|Secondary|Summary and Analysis of Overall Study Response Rate - mITT Population|A patient was characterized as an overall weekly responder if the patient met both the stool consistency and pain response definitions for a given week. A patient was characterized as a composite study responder if the patient met the criteria for both weekly stool consistency and pain response for at least 50% of the planned weeks of treatment.|8 weeks||||Participants|||Count of Participants
2554531|NCT02757105|Secondary|Summary and Analysis of Overall Worst Abdominal Pain Response Rate - mITT Population|A weekly pain responder was defined as a patient who experienced a decrease in the weekly average of worst abdominal pain in the past 24 hours score ≥30% compared with baseline and no increase in the number of days per week with Type 6 or 7 stool consistency. An overall pain responder was defined as a patient who was a weekly pain responder for at least 50% of the planned weeks of treatment.|8 weeks||||Participants|||Count of Participants
2554532|NCT02757105|Primary|Summary and Analysis of Overall Stool Consistency Response Rate by Baseline CRP ≤ Median - mITT Population|A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.|8 weeks|Patients with Baseline CRP ≤ Median|||Participants|||Count of Participants
2554533|NCT02757105|Primary|Summary and Analysis of Overall Stool Consistency Response Rate by Baseline CRP > Median - mITT Population|A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.|8 weeks|Patients with Baseline CRP > Median|||Participants|||Count of Participants
2554534|NCT02757105|Primary|Summary and Analysis of Overall Stool Consistency Response Rate: Sensitivity Analysis Without Imputation for Use of Rescue Medication - mITT Population|A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.|8 weeks||||Participants|||Count of Participants
2554535|NCT02757105|Primary|Summary and Analysis of Overall Stool Consistency Response Rate Females - mITT Population|A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.|8 weeks||||Participants|||Count of Participants
2554578|NCT02756689|Secondary|Patient Satisfaction Six Simple Questions, Q1|"Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7.~1=strongly agree, 4 = neutral, 7=strongly agree.~Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction.~Ranges: 1-7 Best score: 7 Worst score: 1"|At discharge.|"Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction.~Ranges: 1-7 Best score: 7 Worst score: 1"|||units on a scale||Inter-Quartile Range|Median
2554536|NCT02757105|Primary|Summary and Analysis of Overall Stool Consistency Response Rate Males - mITT Population|A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.|8 weeks||||Participants|||Count of Participants
2554537|NCT02757105|Primary|Summary and Analysis of Overall Stool Consistency Response Rate - mITT Population|A weekly stool consistency responder was defined in the FDA guidance on IBS-D as a patient who experienced (during a week) a ≥50% reduction in the number of days with at least one stool that has a consistency of Type 6 or 7 on the Bristol stool scale compared with baseline. In addition, to be considered a responder for the week, the patient could not have had an increase in average abdominal pain >10% over baseline during that week. A patient was characterized as an overall stool consistency responder if the patient was a weekly responder for at least 50% of the planned weeks of treatment.|8 weeks|Modified intent-to-treat (mITT) population analyzed included all patients who took at least one dose of double blinded study drug after randomization. In the mITT population, patients were analyzed by the treatment to which they were randomized. The population was used for a statistical analysis of efficacy endpoints.|||Participants|||Count of Participants
2554538|NCT02757053|Secondary|Number of MRI Brain SWI and FLAIR Lesions in Postseason High School Football Players|Establish the incidence of MRI Brain SWI and FLAIR lesions in postseason high school football players|within two months of the end of high school football season|Study was prematurely terminated due to the PI leaving the area. A few participants did enroll with baseline data only being collected prior to termination. No outcome data collected.||||||
2554539|NCT02757053|Secondary|Number of MRI Brain SWI and FLAIR Lesions in Preseason High School Football Players|Establish the expected range of MRI Brain SWI and FLAIR lesions in the general high school population at the beginning of a high school football season|within two months of the start of high school football season|Study was prematurely terminated due to the PI leaving the area. A few participants did enroll with baseline data only being collected prior to termination. No outcome data collected.||||||
2554540|NCT02757053|Secondary|ImPact Concussion Scores Pre and Post High School Football Season With and Without the Guardian Cap|Establish the expected range of ImPact concussion scores pre and post football season with and without the Guardian Cap|within the first two months after the high school football season ends|Study was prematurely terminated due to the PI leaving the area. A few participants did enroll with baseline data only being collected prior to termination. No outcome data collected.||||||
2554541|NCT02757053|Primary|MRI Brain SWI and FLAIR Lesions Pre and Post High School Football Season With and Without the Guardian Cap|MRI Brain SWI Lesions pre and post football season with and without the Guardian Cap|within the first two months after the high school football season ends|Study was prematurely terminated due to the PI leaving the area. A few participants did enroll with baseline data only being collected prior to termination. No outcome data collected.||||||
2554542|NCT02756949|Secondary|Linkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)|To test whether among individuals aged 18-30 years linkage to HIV care is improved by providing new HIV clients with access to a smartphone-enabled application (app) when compared to standard of care around 6 months post-diagnosis.|Recruitment +8 months||||Participants|||Count of Participants
2554543|NCT02756949|Primary|Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)|To test whether linkage to HIV care is improved by providing new HIV clients with access to a smartphone-enabled application (app) when compared to standard of care around 6 months post-diagnosis.|Recruitment +8 months|Eight standard of care participants removed from analysis due to contamination of the intervention.|||Participants|||Count of Participants
2554544|NCT02756832|Secondary|Percentage of Participants Who Used Healthcare Resources|Healthcare resources included rate of hospitalization, emergency, emergency room visits, physician office visits, and other type of usage.|Baseline up to Month 6|All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study.|||percentage of participants||95% Confidence Interval|Number
2554545|NCT02756832|Secondary|Percentage of Participants With a Decrease in HbA1c Level by ≥0.3% at Month 6|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Percentage of participants with a decrease of ≥0.3% from baseline in HbA1c were reported.|Baseline and Month 6|All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study.|||percentage of participants||95% Confidence Interval|Number
2554546|NCT02756832|Secondary|Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time|The change between the total cholesterol triglycerides, low density lipoproteins and high density lipoproteins values were collected at Months 3 and 6 relative to baseline.|Baseline, Months 3 and 6|All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.|||mmol/l||Standard Deviation|Mean
2554547|NCT02756832|Secondary|Change From Baseline in Postprandial Glycemia Over Time|The change between the baseline (pre-prandial (before meal)) and postprandial (after meal) glucose values were collected at Months 3 and 6 relative to baseline.|Baseline, Months 3 and 6|All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.|||mmol/l||Standard Deviation|Mean
2554548|NCT02756832|Secondary|Change From Baseline in Weight Over Time|Change in the participant's weight was collected at Months 3 and 6 relative to baseline.|Baseline, Months 3 and 6|All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.|||kg||Standard Deviation|Mean
2554551|NCT02756832|Secondary|Change From Baseline in HbA1c Level Over Time|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Months 3 and 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.|Baseline, Months 3 and 6|All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2554552|NCT02756832|Secondary|Percentage of Participants With a Decrease in HbA1c Level by <7.0% at Month 6|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Percentage of participants with a decrease of <7.0% from baseline in HbA1c were reported.|Baseline and Month 6|All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study.|||percentage of participants||95% Confidence Interval|Number
2554553|NCT02756832|Secondary|Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. Subgroups included participants with different baseline clinical characteristics with predictors such as prior therapy of diabetes mellitus, sex, age group, cardiovascular risk group, therapy type (monotherapy or combined therapy), baseline body mass index (BMI) and initial glycemic control and T2DM duration. A negative change from Baseline indicates improvement.|Baseline and Month 6|All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2554554|NCT02756832|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.|Baseline and Month 6|All participants with a diagnosis of diabetes mellitus type 2 (T2DM), newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2554555|NCT02756819|Secondary|Percentage of Participants Who Achieved Target Blood Pressure (BP) in Subgroups of Participants at Month 6|Target BP was SBP<140 mm Hg and DBP<90 mm Hg. Subgroups included BMI, overweight, Obesity I (BMI 30-34.9), class II (BMI 35-39.9) and class III (BMI ≥ 40), impaired glucose tolerance (Yes/No), metabolic syndrome (Yes/No) and diabetes mellitus (Yes/No).|Month 6|FAS included all participants who were enrolled and received azilsartan medoxomil (Edarbi®) therapy. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2554556|NCT02756819|Secondary|Change From Baseline in Clinic Diastolic Blood Pressure (DBP) in Subgroups of Participants at Month 6|The change in clinic sitting DBP measured at Month 6 relative to baseline. Subgroups included overweight, obesity I (basic metabolic rate [BMI] 30-34.9), class II (BMI 35-39.9) and class III (BMI ≥ 40), impaired glucose tolerance, normal glucose metabolism, diabetes mellitus (Yes/No), metabolic syndrome, neither diabetes mellitus nor metabolic syndrome.|Baseline and Month 6|FAS included all participants who were enrolled and received azilsartan medoxomil (Edarbi®) therapy. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||percentage of participants||Standard Deviation|Mean
2554557|NCT02756819|Secondary|Change From Baseline in Clinic Systolic Blood Pressure (SBP) in Subgroups of Participants at Month 6|The change in clinic sitting SBP measured at Month 6 relative to baseline. Subgroups included overweight, obesity I (basic metabolic rate [BMI] 30-34.9), class II (BMI 35-39.9) and class III (BMI ≥ 40), impaired glucose tolerance, normal glucose metabolism, diabetes mellitus (Yes/No), metabolic syndrome, neither diabetes mellitus (DM) nor metabolic syndrome.|Baseline and Month 6|FAS included all participants who were enrolled and received azilsartan medoxomil (Edarbi®) therapy. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||mmHg||Standard Deviation|Mean
2554558|NCT02756819|Secondary|Percentage of Participants Who Achieved Target Blood Pressure (BP) SBP<140 mm Hg and DBP<90 mm Hg||Month 6|Participants from FAS, all participants who were enrolled and received azilsartan medoxomil (Edarbi®) therapy with data available for analysis at the given time point.|||percentage of participants||95% Confidence Interval|Number
2554559|NCT02756819|Secondary|Percentage of Participants With Response at Month 6|Response was defined as a decrease of SBP ≥20 mm Hg or a decrease of DBP ≥10 mm Hg.|Month 6|Participants from FAS, all participants who were enrolled and received azilsartan medoxomil (Edarbi®) therapy with data available for analysis at the given time point.|||percentage of participants||95% Confidence Interval|Number
2554560|NCT02756819|Secondary|Change From Baseline in Clinic Diastolic Blood Pressure (DBP) at Month 6|The change in clinic sitting DBP measured at Month 6 relative to baseline.|Baseline and Month 6|FAS included all participants who were enrolled and received azilsartan medoxomil (Edarbi®) therapy. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||mmHg||Standard Deviation|Mean
2554561|NCT02756819|Primary|Change From Baseline in Clinic Systolic Blood Pressure (SBP) at Month 6|The change in clinic sitting SBP measured at Month 6 relative to baseline.|Baseline and Month 6|Full analysis set (FAS) included all participants who were enrolled and received azilsartan medoxomil (Edarbi®) therapy. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||mmHg||Standard Deviation|Mean
2554579|NCT02756689|Secondary|Number of Neonates Admitted to the Neonatal Intensive Care Unit Admissions|The rates of neonatal intensive care unit admissions will be calculated.|Assessed at time of delivery up to time of neonatal discharge, up to 30-days||||neonates|||Number
2554562|NCT02756689|Secondary|Patient Satisfaction (Labor Pain Scale, Question 4)|"Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of Foley balloon, and likeliness of recommending method of induction to a friend.~Questions 4: How likely are you to recommend your method of induction to a friend or family member. Scale 0-100. 0= very unlikely, 100= very likely.~Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction.~Ranges: 0-100 Best score: 100 Worst score: 0"|At discharge|"Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction.~Ranges: 0-100 Best score: 100 Worst score: 0"|||units on a scale||Inter-Quartile Range|Median
2554563|NCT02756689|Secondary|Patient Satisfaction (Labor Pain Scale, Question 3)|"Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of Foley balloon, and likeliness of recommending method of induction to a friend.~Questions 3: Worse amount of pain experienced during the placement of the Foley balloon. Scale 0-100. 1 = no pain, 100 = pain as bad as it could possibly be.~Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction.~Ranges: 0-100 Best score: 100 Worst score: 0"|At discharge|"Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction.~Ranges: 0-100 Best score: 100 Worst score: 0"|||units on a scale||Inter-Quartile Range|Median
2554564|NCT02756689|Secondary|Patient Satisfaction (Labor Pain Scale, Question 2)|"Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of Foley balloon, and likeliness of recommending method of induction to a friend.~Questions 2: Overall pain experienced during labor. Scale 0-100. 1 = no pain, 100 = pain as bad as it could possibly be.~Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction.~Ranges: 0-100 Best score: 100 Worst score: 0"|At discharge|"Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction.~Ranges: 0-100 Best score: 100 Worst score: 0"|||units on a scale||Inter-Quartile Range|Median
2554565|NCT02756689|Secondary|Patient Satisfaction (Labor Pain Scale, Question 1)|"Assessed through a survey (Labor pain scale). Survey assesses worst amount of pain during labor, overall amount of pain, pain associated with placement of Foley balloon, and likeliness of recommending method of induction to a friend.~Questions 1: Worst amount of pain experienced during labor. Scale 0-100. 1 = no pain, 100 = pain as bad as it could possibly be.~Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction.~Ranges: 0-100 Best score: 100 Worst score: 0"|At discharge|"Title: Likert scale for patient satisfaction. Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction using a Likert scale. This is a way to assess from 0 to 100 patient satisfaction.~Ranges: 0-100 Best score: 100"|||units on a scale||Inter-Quartile Range|Median
2554566|NCT02756689|Secondary|Patient Satisfaction (Lady-X, Question 7)|"Assessed through a validated survey, Lady-X. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864.~Question 7: Time until first contact with your child. Scale 1-3. 1 = Did not take long, 2 = Took quite a long time, 3 = Took a very long time.~Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction.~Ranges: 1-3 Best score: 1 Worst score: 3"|At discharge|"Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction.~Ranges: 1-3 Best score: 1 Worst score: 3"|||units on a scale||Inter-Quartile Range|Median
2554567|NCT02756689|Secondary|Patient Satisfaction (Lady-X Survey, Question 6)|"Assessed through a validated survey, Lady-X. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864.~Question 6: Worries about the health of your child during childbirth. Scale 1-3; 1 = not worried, 2 = somewhat worried, 3 = very worried.~Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction.~Ranges: 1-3 Best score: 1 Worst score: 3"|At discharge|"Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction.~Ranges: 1-3 Best score: 1 Worst score: 3"|||units on a scale||Inter-Quartile Range|Median
2554568|NCT02756689|Secondary|Patient Satisfaction (Lady-X Survey, Question 5)|"Assessed through a validated survey, Lady-X. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864.~Question 5: Feeling of security during childbirth: Scale 1-3. 1 = very safe, 2 = sufficiently safe, 3 = insufficiently safe.~Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction.~Ranges: 1-3 Best score: 1 Worst score: 3"|At discharge|"Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction.~Ranges: 1-3 Best score: 1 Worst score: 3"|||units on a scale||Inter-Quartile Range|Median
2554580|NCT02756689|Secondary|Number of Neonates With Birth Injuries|Cephalohematomas, subgaleal hematomas, fracture of the clavicle, and scalp lacerations|Assessed at time of delivery up to time of neonatal discharge, up to 30 days.||||neonates|||Number
2554581|NCT02756689|Secondary|Number of Neonates With an Umbilical Cord Artery Base Deficit Less Than Negative 12|Base deficit is a lab value.|Assessed at time of delivery up to 5-minutes post-delivery.||||neonates|||Number
2554582|NCT02756689|Secondary|Number of Neonates With Umbilical Artery Cord pH < 7.1||Assessed at time of delivery up to 5-minutes post-delivery.||||neonates|||Number
2554569|NCT02756689|Secondary|Patient Satisfaction (Lady-X Survey, Question 4)|"Assessed through a validated survey, Lady-X Survey. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864.~Question 4: Emotional support by healthcare professionals during childbirth. Scale 1-3. 1 = Very well supported, 2 = adequately supported, 3 = inadequately supported.~Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction.~Ranges: 1-3 Best score: 1 Worst score: 3"|At discharge|"Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction.~Ranges: 1-3 Best score: 1 Worst score: 3"|||units on a scale||Inter-Quartile Range|Median
2554570|NCT02756689|Secondary|Patient Satisfaction (Lady-X Survey, Question 3)|"Assessed through a validated survey, Lady-X Survey. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864.~Question 3: Taking your wishes seriously during childbirth. Scale 1-3. 1 = Very seriously, 2 = sufficiently, 3 = insufficiently~Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction.~Ranges: 1-3 Best score: 1 Worst score: 3"|At discharge|"Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction.~Ranges: 1-3 Best score: 1 Worst score: 3"|||units on a scale||Inter-Quartile Range|Median
2554571|NCT02756689|Secondary|Patient Satisfaction (Lady-X Survey, Question 2)|"Assessed through a validated survey, Lady-X Survey. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864.~Question 2: Information given by the healthcare professionals during childbirth. Scale 1-3. 1 = I felt very well informed by the healthcare professionals, 2 = I felt adequately informed by the healthcare professionals, 3 = I felt inadequately informed by the healthcare professionals.~Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction.~Ranges: 1-3 Best score: 1 Worst score: 3"|At discharge|"Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction.~Ranges: 1-3 Best score: 1 Worst score: 3"|||units on a scale||Inter-Quartile Range|Median
2554572|NCT02756689|Secondary|Patient Satisfaction (Lady-X Survey, Question 1)|"Assessed through a validated survey, Lady-X. Adapted from Gartner FR, de Bekker-Grob EW et al. Calculating preference weights for the labor and delivery index: A discrete choice experiment on women's birth experiences. Value Health. 2015 Sep; 856-864.~Question 1: Presence of healthcare professionals during my birth. Scale 1-3. 1 = At all times, 2 = Most of the time, 3 = rarely~Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction.~Ranges: 1-3 Best score: 1 Worst score: 3"|At discharge|"Title: Lady-X Survey Definition: A survey to assess patient satisfaction and experience during their cervical ripening and induction.~Ranges: 1-3 Best score: 1 Worst score: 3"|||units on a scale||Inter-Quartile Range|Median
2554573|NCT02756689|Secondary|Patient Satisfaction (Six Simple Questions, Question 6)|"Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7.~Question 6: I would choose the same type of care for my next pregnancy. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree.~Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction.~Ranges: 1-7 Best score: 7 Worst score: 1"|At discharge|"Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction.~Ranges: 1-7 Best score: 7 Worst score: 1"|||units on a scale||Inter-Quartile Range|Median
2554574|NCT02756689|Secondary|Patient Satisfaction (Six Simple Questions, Question 5)|"Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7.~Question 5: The overall organization of my ca re has not been appropiate. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree.~Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction.~Ranges: 1-7 Best score: 7 Worst score: 1"|At discharge|"Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction.~Ranges: 1-7 Best score: 7 Worst score: 1"|||units on a scale||Inter-Quartile Range|Median
2554575|NCT02756689|Secondary|Patient Satisfaction (Six Simple Questions, Question 4)|"Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7.~Question 4: My needs have been addressed with appropriate consideration for my time. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree.~Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction.~Ranges: 1-7 Best score: 7 Worst score: 1"|At discharge|"Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction.~Ranges: 1-7 Best score: 7 Worst score: 1"|||units on a scale||Inter-Quartile Range|Median
2554576|NCT02756689|Secondary|Patient Satisfaction (Six Simple Questions, Question 3)|"Assessed through validated survey, Six Simple Questions. Adapted from Harvey S, Rach D, et al. Evaluation of satisfaction with midwifery care. 2002 Dec; 18(4):260-7.~Question 3: Problems that have arisen up to now have not been dealt with effectively. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree.~Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction.~Ranges: 1-7 Best score: 7 Worst score: 1"|At discharge|"Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction.~Ranges: 1-7 Best score: 7 Worst score: 1"|||units on a scale||Inter-Quartile Range|Median
2554577|NCT02756689|Secondary|Patient Satisfaction (Six Simple Questions, Question 2)|"Assessed through validated survey (Six simple questions, Q-2). Question 2: The person(s) responsible for my care are/were caring and compassionate. Scale 1-7. 1=strongly agree, 4 = neutral, 7=strongly agree.~Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction.~Ranges: 1-7 Best score: 7 Worst score: 1"|At discharge|"Title: Six simple questions Definition: A survey to assess patient satisfaction during their cervical ripening and induction.~Ranges: 1-7 Best score: 7 Worst score: 1"|||units on a scale||Inter-Quartile Range|Median
2554591|NCT02756689|Secondary|Number of Participants With Chorioamnionitis||Assessed from baseline to delivery.||||Participants|||Count of Participants
2554605|NCT02756624|Primary|Tolerability of AC 170 0.24% at Visit 3 (Day 22)|Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2554606|NCT02756624|Primary|Tolerability of AC 170 0.24% at Visit 2 (Day 8)|Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2554607|NCT02756624|Primary|Tolerability of AC 170 0.24% at Visit 1 (Day 1)|Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2554608|NCT02756351|Secondary|Any Adverse Events Such as Skin Reactions, Allergic Reactions, Abrasions, Shears or Wounds Due to Contact or Pressure of the Device on the Nose of Subjects Occurring During the Study.||18 hours||||Adverse Events|||Number
2554609|NCT02756351|Primary|Mean Difference in Bacterial Colonization of the Nasal Prong After 18 Hours of Device Usage When Comparing the CytaCoat Nasal Prong to the Reference Device.||18 hours||||fold change in log value||Standard Deviation|Mean
2554610|NCT02756338|Secondary|Characterization of Device Functionality Post-insertion: R-wave Amplitudes|This includes average R-wave amplitudes collected at insertion, wound check, and 90-day study visits. Long-term trends available through Home Monitoring from insertion through the 90-day study period was also collected and presented as a separate average.|Insertion, Wound Check (5 to 14 days post-insertion), 90-day (75 to 120 days post-insertion)|Five subjects did not complete their 90-day visits as reported in Participant Flow and therefore data was not collected for those visits. Only one subject did not transmit to Home Monitoring due to poor reception and therefore there was no data for this patient in Home Monitoring.|||millivolts (mV)||Standard Deviation|Mean
2554611|NCT02756338|Secondary|Characterization of Insertion Procedure: Procedure Duration||At insertion||||minutes||Standard Deviation|Mean
2554612|NCT02756338|Secondary|Characterization of Insertion Procedure: Incision Size||At insertion|Number of participants analyzed included all subjects with a reported incision size. Incision size was not collected or reported for 3 participants.|||millimeters||Standard Deviation|Mean
2554613|NCT02756338|Secondary|Characterization of Insertion Procedure: Device Orientation|Position A includes orientations at 45 degrees relative to the sternum over the fourth intercostal space, position B includes orientations parallel to the sternum over the fourth intercostal space, and position C includes orientations perpendicular to the sternum and sub-mammary.|At insertion|All subjects who underwent insertion|||Participants|||Count of Participants
2554614|NCT02756338|Secondary|Number of Participants With Insertion Procedure-related Adverse Event Not Included in Primary Objective|All insertion procedure-related adverse events not included in the Primary Objective|Insertion through 90 days|The evaluable subject population is the sum of total unique subjects who completed the 90-day follow-up and/or who experienced a secondary objective adverse event.|||Participants|||Count of Participants
2554615|NCT02756338|Primary|Number of Participants With Insertion Procedure-related Adverse Event That Requires Additional Invasive Intervention to Resolve|In order to be included in the primary objective analysis, insertion procedure-related adverse events must also include resolution by invasive action such as device removal, device replacement, surgical repositioning of the device, or another surgery preformed related to the device or primary insertion procedure.|Insertion through 90 days|The evaluable subject population is the sum of total unique subjects who completed the 90-day follow-up and/or who experienced a primary objective adverse event.|||participants with a Primary Objective AE|||Number
2554616|NCT02756182|Secondary|Maximum Detrusor Pressure During Coughs|Maximum detrusor pressure during coughs was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.|Measured during a single urodynamic evaluation||||cmH2O||Standard Deviation|Mean
2554617|NCT02756182|Secondary|Maximum Abdominal Pressure During Coughs|Maximum abdominal pressure during coughs was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.|Measured during a single urodynamic evaluation||||cmH2O||Standard Deviation|Mean
2554618|NCT02756182|Secondary|Maximum Vesical Pressure During Coughs|Maximum vesical pressure during coughs was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.|Measured during a single urodynamic evaluation||||cmH2O||Standard Deviation|Mean
2554619|NCT02756182|Primary|Maximum Detrusor Pressure at Valsalva Manoeuvres|Maximum detrusor pressure during Valsalva manoeuvres was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.|Measured during a single urodynamic evaluation||||cmH2O||Standard Deviation|Mean
2554620|NCT02756182|Primary|Maximum Abdominal Pressure During Valsalva Manoeuvres|Maximum abdominal pressure during Valsalva manoeuvres was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.|Measured during a single urodynamic evaluation||||cmH2O||Standard Deviation|Mean
2554621|NCT02756182|Primary|Maximum Vesical Pressure During Valsalva Manoeuvres|Maximum vesical pressure during Valsalva manoeuvres was measured with an air-filled catheter and the water pressure was measured from the fill port. Air-filled catheter and water pressure measurements were compared.|Measured during a single urodynamic evaluation||||cmH2O||Standard Deviation|Mean
2554622|NCT02756078|Secondary|Comfort at the End of the Day|Subjects graded the comfort level at the end of the day using 5- point scale (1=excellence, 2=very good, 3=good, 4=fair and 5=poor). The average end of day comfort grade was reported for each lens type.|Up to 4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||units on a scale||Standard Deviation|Mean
2554623|NCT02756078|Secondary|Difference in Total Device Use Time and Comfortable Wear Time During Device Use|Subjects reported the total duration of their digital device use and comfortable lens wear time during digital device use.|Up to 4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||Hours||Standard Deviation|Mean
2554624|NCT02756078|Secondary|Average Comfortable Wear Time|Average comfortable lens wear time with the study lenses were recorded in hour at each follow-up visit.|Up to 4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||Hours||Standard Deviation|Mean
2554625|NCT02756078|Secondary|Average Wear Time|Average lens wear time with the study lenses were recorded in hour at each follow-up visit.|Up to 4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||Hours||Standard Deviation|Mean
2554626|NCT02756078|Secondary|Time to Haze|Time to haze measure the maximum time a contact lens wearers can keep their eye open without their vision becoming hazy. It was a measure of how the drying of the contact lens surface with open eyes affects vision.|Up to 4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||seconds||Standard Deviation|Mean
2554627|NCT02756078|Secondary|Overall CLUE Handling|Overall Handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|Up to 4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||Units on a Scale||Standard Deviation|Mean
2554628|NCT02756078|Primary|Overall CLUE Comfort|Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|Up to 4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||Units on a Scale||Standard Deviation|Mean
2554629|NCT02755935|Primary|Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear|unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in noise|3 months post-activation|implanted and enrolled|||percent correct||Standard Deviation|Mean
2554630|NCT02755935|Primary|Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear|Unilateral listening performance at 3 months post activation with the CI532 compared to the best aided unilateral preoperative condition for sentence perception in quiet.|3 months postactivation of the sound processor|implanted and enrolled|||percent correct||Standard Deviation|Mean
2554631|NCT02755831|Secondary|Hospital Costs at Time of Delivery|Hospital costs at time of delivery in treatment and control group.|Hospital costs at time of delivery||||dollars||95% Confidence Interval|Mean
2554632|NCT02755831|Secondary|Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group|Incidence and severity of OSA at 8 to 12 weeks postpartum in treatment and control group.|8-12 weeks postpartum|Incidence and Severity of OSA at 8-12 weeks postpartum. This is the only time point in which both groups completed sleep studies.|||Participants|||Count of Participants
2554633|NCT02755831|Secondary|Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks)|Incidence and severity of OSA in late pregnancy- treatment group only (27-33 weeks). Data were not collected for Control group at this time point|27-33 weeks|Incidence and Severity of OSA in Late Pregnancy. Outcome data was only collected in the treatment group. Data were not collected for Control group at this time point|||Participants|||Count of Participants
2554634|NCT02755831|Secondary|Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks)|Incidence of OSA severity in early pregnancy (6-16 weeks) in treatment group only. Data were not collected for Control group at this time point.|early pregnancy (6-16 weeks)|Friedman’s test was used to analyze differences in sleep study results at the three time points in experimental group. If significant differences are found in sleep study results a post hoc Wilcoxon Ranked Sign test will be used to compare differences at individual time points. Data were not collected for Control group at this time point.|||Participants|||Count of Participants
2554635|NCT02755831|Primary|Number of Participants With Adverse Pregnancy Outcomes|Number of participants with adverse pregnancy outcomes (composite outcome includes: gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm delivery, low birth weight, or stillbirth)|time of delivery||||Participants|||Count of Participants
2554636|NCT02755818|Primary|CETP Activity (Lecithin-Cholesterol Acyltransferase) in Control and Chronic Kidney Disease Groups, Mainly to CKD3b, CKD4|"CETP activity measures the transfers of neutral lipids from high density lipoproteins (HDL) to very low density lipoprotein (VLDL) and low density lipoprotein (LDL). CETP may give us the other clue to lipoprotein metabolism and reverse cholesterol transport pathway~No data collected- no standard deviation calculated"|"This is a cross sectional study; only one measurement collected, termed baseline"|Data not generated - due to insufficient number of patient recruited in CKD4 and CKD3b for comparison and analysis||||||
2554637|NCT02755818|Primary|LCAT Activity (Lecithin-Cholesterol Acyltransferase) in Control and Chronic Kidney Disease Groups, Mainly to CKD3b, CKD4|"LCAT measures phospholipase activity in plasma. Measuring LCAT activity may be useful in clarifying the aspects of lipid metabolism in relation to reverse cholesterol transport~No data collected- no standard deviation calculated"|"This is a cross sectional study; only one measurement collected, termed baseline"|Data not generated - due to insufficient number of patient recruited in CKD4 and CKD3b for comparison and analysis||||||
2554638|NCT02755818|Primary|Insulin Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups|Insulin is a hormone made by the pancreas that allows the body to use or store sugar (glucose) from the food eaten. Insulin regulates blood sugar level.|"This is a cross sectional study; only one measurement collected, termed baseline"|Data missing (1) for CKD4 and CKD5 group|||uU/mL||Standard Deviation|Mean
2554639|NCT02755818|Primary|Body Mass Index (BMI) in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups|Body Mass Index (BMI) is calculated from subject's weight (kilogram) and height (meter)|"This is a cross sectional study; only one measurement collected, termed baseline"||||kg/m2||Standard Deviation|Mean
2554640|NCT02755818|Primary|C Reactive Protein (CRP) Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups|C-reactive protein (CRP) is an inflammation marker produced by the liver. An increase in CRP value may means inflammation in the body.|"This is a cross sectional study; only one measurement collected, termed baseline"|Data missing (1) for CKD4 group|||mg/dL||Standard Deviation|Mean
2554641|NCT02755818|Primary|LDL Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups|LDL (low-density lipoprotein), is a type of cholesterol (fat) circulating in the blood vessels, and can form plaques. High levels of LDL cholesterol may raise your risk for heart disease and stroke.|"This is a cross sectional study; only one measurement collected, termed baseline"|Data missing (1) for CKD4 group|||mg/dL||Standard Deviation|Mean
2554642|NCT02755818|Primary|HDL (High Density Lipoprotein) Level in Control and Chronic Kidney Disease (CKD 3b, 4, 5) Groups|"HDL (high-density lipoprotein), is called good cholesterol. It binds to cholesterols marked for disposal back to the liver to be digested and disposed by the body. High HDL level may lower your risk for heart disease and stroke."|"HDL (high density lipoprotein) (mg/dL) -- this is a cross sectional study; only one measurement collected, termed baseline"|Data missing (1) for CKD4 group|||mg/dL||Standard Deviation|Mean
2554643|NCT02755805|Secondary|Differences in Apathy Symptoms Between Groups Over Time|"Difference in mean Apathy Evaluation Scale total scores were examined between groups over time using repeated measures fixed effects models.~The Apathy Evaluation Scale measures lack of motivation or interest in goal-directed activities. The scale has 18 items yielding a total score of 18 (indicating absence of apathy) to 72 (indicating severe apathy). Total scores were generated for each participant at each time, and mean scores were computed for each group at each time point."|Baseline, 3 months, 6 months||||units on a scale||Standard Error|Mean
2554644|NCT02755805|Secondary|Difference in Executive Function - Cognitive Flexibility, CWI (Color Word Interference Switching Scale)|"Difference between groups in mean scaled scores (Color Word Interference Switching Scale) over time using mixed effects models.~The Cognitive Flexibility Scale raw scores were converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point."|Baseline, 3 months, 6 months||||units on a scale||Standard Error|Mean
2554645|NCT02755805|Secondary|Difference in Executive Function- Inhibition, CWI (Color Word Interference Inhibition Scale)|"Difference mean scaled scores (Color Word Interference Inhibition Scale) between groups over time using mixed effects models.~The Color Word Interference Inhibition Scale raw scores are converted to norm-referenced scaled scores adjusted for age and education. These scores are aligned with a population mean of 10, and standard deviation of 3. Higher scores indicate better executive function. Scaled scores were generated at baseline, month 3, and month 6 for each participant, and mean scaled scores were computed for each group at each time point."|Baseline, 3 months, 6 months||||units on a scale||Standard Error|Mean
2554646|NCT02755805|Primary|Difference in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time|"Difference between groups in mean scores (computed from Functional Independence Measure total scores) over time were examined with mixed effects models.~The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated at baseline, rehabilitation discharge, month 3, and month 6 for each participant, and mean total scores were calculated fro each group at each time point."|Baseline, rehabilitation discharge, month 3, month 6||||units on a scale||Standard Error|Mean
2554647|NCT02755129|Primary|Correlation of Gait Speed Between Reveal LINQ Accelerometer, Validation Accelerometer and/or Computer Assisted Rehabilitation System by Walking Exercises|"The gait speed will be calculated from the Reveal LINQ accelerometer signals, from the validation accelerometer and / or from the computer assisted rehabilitation system during the walking exercises.~We will calculate the average correlation coefficient over all patients and exercises.~It is reported as score on a scale, with minimum value= -1 and maximum value = 1.~Higher absolute values mean higher correlation."|During walking exercises visit, 1 Day|"15 subjects were enrolled and completed the study. All subjects met the inclusion and exclusion criteria.~One subject did not have readable device data and as such was excluded from the analysis."|||Correlation Coefficient|||Number
2554648|NCT02755090|Primary|Satisfaction With Anesthesia (Iowa Satisfaction With Anesthesia Scale [ISAS])|The Iowa Satisfaction with Anesthesia Scale (ISAS) was given to women following a surgical abortion. The ISAS score is the mean of 11 responses to questions regarding satisfaction with anesthesia and has a score range of -3 (disagree strongly) to 3 (agree strongly).|Assessed 30 minutes after procedure completion.||||units on a scale||Standard Deviation|Mean
2554649|NCT02755090|Primary|Visual Analog Scale (VAS) Score for Maximum Procedural Pain|To compare women's maximum procedural pain measured on a visual analog scale (VAS) during a surgical abortion between 12 weeks 0 days to 16 weeks 0 days gestational age between women randomized to nitrous oxide versus intravenous sedation. A score of 0 represents no pain and a score of 100 represents pain as bad as it could be.|Assessed immediately following completion of the procedure (as defined as removal of the speculum)||||units on a scale||Full Range|Mean
2554650|NCT02754674|Secondary|Graft Maturity (SNQ)||1 yr after surgery||||SNQ||Standard Deviation|Mean
2554651|NCT02754674|Secondary|Instability|The side-to-side difference was measured using a KT-200- arthrometer (MEDmetric) at 30 lb in 30° of knee flexion.|2 yr after surgery||||mm||Standard Deviation|Mean
2554652|NCT02754674|Secondary|Clinical Knee Scoring|"Lysholm score (ragne 0-100), HSS (hospital for special surgery) score (0-100) , IKDC (international knee doucomentation commitee) subjective score (0-100), Tegner activity scale (0-10).~All of scores demonstrated that higher score means a better outcomes."|2 yr after surgery||||score||Standard Deviation|Mean
2554803|NCT02752074|Secondary|Apparent Oral Clearance (CL/F) of Epacadostat|Defined as oral dose clearance.|Through up to 30 days after the end of treatment, up to 25 months|All randomized participants enrolled in the Epacadostat arm currently with melanoma.|||Liter/hour (L/h)||Standard Deviation|Mean
2554653|NCT02754674|Secondary|Arthroscopy Grading|"Graft continuity was graded as no tears, superficial tear (fibrillation or tear of superficial fibers), or substantial tear (rupture of 1 or more strands).~Graft tension was graded as taut, mild lax, and lax by probing at knee flexion and extension.~Synovial coverage of the grafts was graded as excellent (synovial coverage > 80% around graft), fair (coverage > 50%), or poor (coverage < 50%) On the second-look arthroscopic examination, graft continuity, graft tension, graft synovialization, and the presence of cyclops lesions were assessed by a senior surgeon."|1yr after surgery||||Participants|||Count of Participants
2554654|NCT02754674|Primary|Vascularity of Graft Tendon|For evaluation of graft vascularity, quantitative parameter of area under the curve (AUC) was measured from DCE-MRI by using an image-processing software (IntelliSpace Portal, version 5.0; Philips Healthcare). A musculoskeletal radiologist manually drew the ROIs for intra-articular portion of the ACL graft including synovial membrane at the proximal, middle and distal zones. The software automatically generated time to signal intensity curves and then calculated the quantitative parameter, area under the time to signal intensity curve values, which were acquired by integrating the area under the time to signal intensity curve. To normalize the AUC (nAUC), we divided the AUC of medial gastrocnemius muscle into that of the ACL graft.|1yr after surgery||||ratio of AUC||Standard Deviation|Mean
2554655|NCT02754661|Secondary|Predictive Value of a Negative (NPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm|"Predictive value of a negative test (NPV) is the percentage of patients with negative tests who do not have disease, assessed in relation to the confirmatory OC results on a per subject basis."|5-6 weeks from randomized procedure|Per protocol Analysis set (PPAS) is comprised of randomized subjects without major protocol deviations (violations with significant impact on subject outcomes) and who don't meet any of the following criteria: Subject withdraws, Capsules remained in the stomach/SB during the entire procedure, colonoscopy could not be done, technical failure|||Participants|||Count of Participants
2554656|NCT02754661|Secondary|Predictive Value of a Positive Test (PPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm|"Predictive value of a positive test (PPV) is the percentage of patients with positive tests who have disease assessed in relation to the confirmatory OC results on a per subject basis"|5-6 weeks from randomized procedure|Per protocol Analysis set is comprised of all randomized subjects without major protocol deviations (violations that may have a significant impact on subject outcomes) and who don't meet any of the following criteria: Subject withdraws, Capsules remained in the stomach/SB during the entire procedure, colonoscopy could not be done, technical failure|||Participants|||Count of Participants
2554657|NCT02754661|Secondary|Specificity of CCE Versus CTC in the Detection of Polyps ≥6 mm|"Specificity (the percentage of patients without disease who test negative) assessed in relation to the confirmatory optical colonoscopy (OC) results on a per subject basis"|5-6 weeks from randomized procedure|Per protocol Analysis (PPAS) set is comprised of randomized subjects without major protocol deviations (violations with significant impact on subject outcomes) and who don't meet any of the following criteria: Subject withdraws, Capsules remained in the stomach/SB during the entire procedure, colonoscopy could not be done, technical failure|||Participants|||Count of Participants
2554658|NCT02754661|Secondary|Sensitivity of CCE Versus CTC in the Detection of Polyps ≥6 mm|"Sensitivity (the percentage of patients with disease who test positive) assessed in relation to the confirmatory optical colonoscopy (OC) results on a per subject basis"|5-6 weeks from randomized procedure|Per protocol Analysis (PPAS) set is comprised of randomized subjects without major protocol deviations (violations with significant impact on subject outcomes) and who don't meet any of the following criteria: Subject withdraws, Capsules remained in the stomach/SB during the entire procedure, colonoscopy could not be done, technical failure|||Participants|||Count of Participants
2554659|NCT02754661|Primary|Number of Participants With an Actionable Lesion on CCE vs. CTC Confirmed by Optical Colonoscopy|"Proportion of subjects shown to have an actionable lesion, defined as any polyp or mass lesion ≥6 mm.~Diagnostic yield of CCE/CTC will be calculated in relation to the confirmatory Optical colonoscopy results"|5-6 weeks from randomized procedure|Per protocol Analysis set (PPAS) is comprised of randomized subjects without major protocol deviations (violations with significant impact on subject outcomes) and who don’t meet any of the following criteria: Subject withdraws, Capsules remained in the stomach/SB during the entire procedure, colonoscopy could not be done, technical failure|||Participants|||Count of Participants
2554660|NCT02754570|Secondary|Change in Ocular Perfusion Pressure|Ocular perfusion pressure will calculated from the intraocular pressure and blood pressure measurements. At Baseline/Visit 2, intraocular pressure and blood pressure will be measured every 2 hours for a 24-hour period. At any point over the next 4 weeks, another 24-hour visit (Visit 3) will be performed. This time, a dose of pilocarpine 2% will be administered at 4 different times in addition to the latanoprost (PGA monotherapy). As before, intraocular pressure and blood pressure will be measured every 2 hours. 8 diurnal readings and 4 nocturnal readings were averaged separately during both Visit 2 for the PGA Monotherapy and Visit 3 for Pilocarpine+PGA|Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3|Patients who are using a prostaglandin analog (PGA) will be monitored at visit two. At visit 3, pilocarpine will be added four times per day to the PGA therapy.|||mmHg||Standard Deviation|Mean
2554661|NCT02754570|Primary|Change in Intraocular Pressure From Baseline at Visit 3|Subjects will be enrolled at the first visit. Patients already on latanoprost may proceed immediately with the second visit. Patients on a different prostaglandin analog medication will be switched to latanoprost for at least 6 weeks. At second visit, intraocular pressure and blood pressure will be measured every 2 hours for a 24-hour period. At any point over the next 4 weeks, another 24-hour visit will be performed. This time, a dose of pilocarpine 2% will be administered at 4 different times in addition to the latanoprost . As before, intraocular pressure and blood pressure will be measured every 2 hours. After visit 3, subjects will return to their prior treatment regimen. Change in the intraocular pressure from the second and the third visit will be determined. 8 diurnal readings and 4 nocturnal readings were averaged separately during both Visit 2 for the PGA Monotherapy and Visit 3 for Pilocarpine+PGA|Two 24-hour visits: Baseline/Visit 2; Up to week 4/Visit 3|Patients who are using a prostaglandin analog (PGA) will be monitored at visit two. At visit 3, pilocarpine will be added four times per day to the PGA therapy.|||mmHg||Standard Error|Mean
2554975|NCT02750501|Secondary|Erythrocyte Composition (%) of EPA|Changes over time in erythrocyte composition (%) for EPA in ITT population|RELiZORB Treatment Period (Day 0-Day 90): 90 days||||percentage of RBC composition||95% Confidence Interval|Least Squares Mean
2554662|NCT02754492|Secondary|Number of Participants With Platelet Units Containing an Acceptable Platelet Yield|The number of participants with platelet units containing an acceptable platelet yield. Acceptable platelet yield for single, double and triple platelet products are: platelet yield ≥ 3.0 × 10^11 for singles, platelet yield ≥ 6.2 × 10^11 for doubles, and platelet yield ≥ 9.3 × 10^11 for triples.|Within 48 hours of end of donation|The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.|||Participants|||Count of Participants
2554663|NCT02754492|Primary|Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level|The number of participants with platelet units containing an acceptable residual WBC level. Acceptable residual WBC counts are: singles = residual WBC level < 5.0 × 10^6; doubles = residual WBC level < 8.0 × 10^6 or < 5.0 × 10^6 for each transfusable unit; and triples = residual WBC level < 12.0 × 10^6 or < 5.0 × 10^6 for each transfusable unit.|Within 48 hours of end of donation|The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.|||Participants|||Count of Participants
2554664|NCT02754440|Secondary|Number of Participants With Platelet Units Containing an Acceptable Platelet Yield|The number of participants with platelet units containing an acceptable platelet yield. Acceptable platelet yield for single, double and triple platelet products are: platelet yield ≥ 3.0 × 10^11 for singles, platelet yield ≥ 6.2 × 10^11 for doubles, and platelet yield ≥ 9.3 × 10^11 for triples.|Within 48 hours of end of donation|The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.|||Participants|||Count of Participants
2554665|NCT02754440|Primary|Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level|The number of participants with platelet units containing an acceptable residual WBC level. Acceptable residual WBC counts are: singles = residual WBC level < 5.0 × 10^6; doubles = residual WBC level < 8.0 × 10^6 or < 5.0 × 10^6 for each transfusable unit; and triples = residual WBC level < 12.0 × 10^6 or < 5.0 × 10^6 for each transfusable unit.|Within 48 hours of end of donation|The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.|||Participants|||Count of Participants
2554666|NCT02754427|Primary|Number of Participants With Arm Morbidity at 12 Months Post-surgery - Arm Volume|Arm morbidity due to increase in arm volume was defined as a ≥200 mL increase from pre-surgery. Arm volume was measured using a perometer.|12 months||||Participants|||Count of Participants
2554667|NCT02754427|Primary|Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Function|Arm morbidity due to decreased upper body function was defined as ≥10 points decrease in function from pre-surgery. This was measured using the Upper Extremity Functional Index that scores 0 to 80, with higher scores indicating greater level of function.|12 months||||Participants|||Count of Participants
2554668|NCT02754427|Primary|Number of Participants With Arm Morbidity at 12 Months Post-surgery - Upper Body Muscle Strength|Arm morbidity due to decreased upper body muscle strength was defined as ≥25% decrease in muscle strength from pre-surgery. This was measured using a hand-held dynamometer and evaluated in kilograms.|12 months||||Participants|||Count of Participants
2554669|NCT02754427|Primary|Number of Participants With Arm Morbidity at 12 Months Post-surgery - Shoulder Mobility|Arm morbidity due to decreased shoulder mobility was defined as ≥10% decrease in mobility from pre-surgery. This was measured using a goniometer and evaluated the degrees of shoulder mobility in flexion, abduction and external rotation.|12 months||||Participants|||Count of Participants
2554670|NCT02754310|Secondary|Management Score on Evaluation Scenario n°2|"The evaluation scenario n°2 is a scenario of a mild asthma exacerbation not responding to treatment, used during the learning phase of the variation group.~The scale mild asthma exacerbation includes different items related to the sequence, the dose, and the administration technique of the treatments. The score ranges between 0 and 16,16 meaning perfect management of the medical condition. The detailed scale can be found in the supplementary material of the article published here: https://link.springer.com/article/10.1007/s00431-017-3054-1."|4 months||||units on a scale||Inter-Quartile Range|Median
2554671|NCT02754310|Secondary|Management Score on Evaluation Scenario n°1|"The evaluation scenario n°1 is a scenario of a moderate asthma exacerbation not responding to treatment, used during the learning phase of both groups (3 times for the group repetition and just once for the group variation) The scale moderate asthma exacerbation includes different items related to the sequence, the dose, and the administration technique of the treatments. The score ranges between 0 and 16,16 meaning perfect management of the medical condition. The detailed scale can be found in the supplementary material of the article published here: https://link.springer.com/article/10.1007/s00431-017-3054-1."|4 months||||units on a scale||Inter-Quartile Range|Median
2554672|NCT02754310|Secondary|Management Score on Transfer Scenario n°4|"The transfer scenario n°4 is a new scenario that learners face for the first time. It is a pediatric laryngitis. Students are expected to realize that the child's presentation differs from an asthma exacerbation and should not start short-acting beta agonists.~The scale Pediatric laryngitis includes different items related to the sequence and the dose of the treatments provided. The score ranges between 0 and 3, 3 meaning perfect management of the medical condition. The detailed scale can be found in the supplementary material of the article published here: https://link.springer.com/article/10.1007/s00431-017-3054-1."|4 months||||units on a scale||Inter-Quartile Range|Median
2554673|NCT02754310|Secondary|Management Score on Transfer Scenario n°3|"The transfer scenario n°3 is a new scenario that learners face for the first time. It is a severe asthma exacerbation improving before relapsing.The scale Asthma exacerbation improving then relapsing includes different items related to the sequence, the dose, and the administration technique of the treatments. The score ranges between 0 and 16, 16 meaning perfect management of the medical condition. The detailed scale can be found in the supplementary material of the article published here: https://link.springer.com/article/10.1007/s00431-017-3054-1."|4 months||||units on a scale||Inter-Quartile Range|Median
2554674|NCT02754310|Secondary|Management Score on Evaluation Scenario n°2|"The evaluation scenario n°2 is a scenario of a mild asthma exacerbation not responding to treatment, used during the learning phase of the variation group.The scale mild asthma exacerbation includes different items related to the sequence, the dose, and the administration technique of the treatments. The score ranges between 0 and 9, 9 meaning perfect management of the medical condition. The detailed scale can be found in the supplementary material of the article published here: https://link.springer.com/article/10.1007/s00431-017-3054-1."|One week||||units on a scale||Inter-Quartile Range|Median
2554675|NCT02754310|Secondary|Management Score on Evaluation Scenario n°1|"The evaluation scenario n°1 is a scenario of a moderate asthma exacerbation not responding to treatment, used during the learning phase of both groups (3 times for the group repetition and just once for the group variation).~The scale moderate asthma exacerbation includes different items related to the sequence, the dose, and the administration technique of the treatments. The score ranges between 0 and 16, 16 meaning perfect management of the medical condition. The detailed scale can be found in the supplementary material of the article published here: https://link.springer.com/article/10.1007/s00431-017-3054-1."|One week||||units on a scale||Inter-Quartile Range|Median
2554676|NCT02754310|Secondary|Management Score on Transfer Scenario n°2|"The transfer scenario n°2 is a new scenario that learners face for the first time. It is a pediatric pneumonia. Students are expected to realize that the child's presentation differs from an asthma exacerbation and should not start short-acting beta agonists nor steroids.~The scale Pediatric Pneumonia includes different items related to the sequence of the treatments administered. The score ranges between 0 and 4, 4 meaning perfect management of the medical condition. The detailed scale can be found in the supplementary material of the article published here: https://link.springer.com/article/10.1007/s00431-017-3054-1."|One week||||units on a scale||Inter-Quartile Range|Median
2554677|NCT02754310|Primary|Management Score on Transfer Scenario n°1|"The transfer scenario n°1 is a new scenario that learners face for the first time. It is a pediatric asthma exacerbation rapidly worsening.~The scale Asthma exacerbation rapidly worsening includes different items related to the sequence, the dose, and the administration technique of the treatments. The score ranges between 0 and 10, 10 meaning perfect management of the medical condition. The detailed scale can be found in the supplementary material of the article published here: https://link.springer.com/article/10.1007/s00431-017-3054-1."|One week||||units on a scale||Inter-Quartile Range|Median
2554678|NCT02753946|Secondary|Number of Patients With a Response of Microbiologic Eradication|mMITT|TOC Visit (Day 19)|Microbiologic Modified Intent-to-Treat (m-MITT) population was used to assess microbiologic eradication.|||Participants|||Count of Participants
2554679|NCT02753946|Secondary|Number of Patients With a Response of Clinical Cure in Various Protocol Populations|mMITT|TOC Visit (Day 19)|Microbiologic Modified Intent-to-Treat (m-MITT) population was used to assess clinical cure.|||Participants|||Count of Participants
2554680|NCT02753946|Primary|Number of Patients With an Overall Success|Clinical cure (resolution or significant improvement in signs and symptoms) and microbiologic eradication (baseline pathogen) in m-MITT population|TOC Visit (Day 19)|Microbiologic Modified Intent-to-Treat (m-MITT) population was used to assess overall success.|||Participants|||Count of Participants
2554681|NCT02753920|Secondary|Proportion of Patients With Unexpected Visits to the Clinic, Within the Six-week Post-operative Period.||6 weeks||||Participants|||Count of Participants
2554682|NCT02753920|Secondary|Number of Subjects Discharged With a Catheter (This is Essentially the Proportion of Patients Who Failed the Voiding Trial)||6 weeks||||Participants|||Count of Participants
2554683|NCT02753920|Primary|Number of Subjects Catheterized Within the Six-week Post-operative Period Following Surgical Repair of Prolapse, Among Those Discharged Without a Urinary Catheter.||6 weeks||||Participants|||Count of Participants
2554684|NCT02753699|Secondary|Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48.|Note that the 24-week period between end of feeder study (SVR24) and first visit in this follow-up study is not counted in the 48 weeks, so this timepoint corresponds to 96 weeks (=24+24+48) after the last dose of alisporivir.|at Week 48|Full analysis set. In the categories, n is the number of subjects in FAS in the appropriate study group with normal ALT at visit; for Overall - at all available visits.|||percentage of participants|||Number
2554685|NCT02753699|Primary|Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48||up to 120 Weeks|Full analysis set (FAS), defined as all participants who enrolled into this study and had at least one HCV RNA assessment, unless excluded due to protocol deviations.|||percentage of participants|||Number
2554686|NCT02753413|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From vaccination (Day 0) up to study end (Day 30)|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2554687|NCT02753413|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During a 30-day follow-up period (from Day 0 to Day 29) after vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2554700|NCT02753075|Secondary|Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8|"Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (No Pain) to 10 (Intense Pain). A reduction in the score is indicative of an improvement in sensitivity."|Baseline, Week 8|ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
2554688|NCT02753413|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, temperature (defined as oral temperature equal to or above [≥] 37.5 degrees Celsius [°C] for oral, axillary or tympanic route), gastrointestinal symptoms (gastro) including nausea, vomiting, diarrhoea and/or abdominal pain; and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During a 7-day follow-up period (from Day 0 to Day 6) after vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2554689|NCT02753413|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimetres (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.|During a 7-day follow-up period (from Day 0 to Day 6) after vaccination|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2554690|NCT02753413|Primary|Number of Subjects With Haematology Change From Baseline by Maximum Grade|Assessed laboratory parameter changed from baseline was haemoglobin (Hgb). FDA grading for Hgb (change from baseline) was not applicable a baseline.|From Day 7 up to Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2554691|NCT02753413|Primary|Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading|Among haematological parameters tested were NEU, PLT, decreased WBC and increased WBC/I, graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.|From Day 7 up to Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2554692|NCT02753413|Primary|Number of Subjects With Abnormal Haematological Laboratory Parameter Values by Maximum Grading|Among haematological parameters tested were EOS, decreased Hgb and LYM graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.|From Day 7 up to Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented|||Participants|||Count of Participants
2554693|NCT02753413|Primary|Number of Subjects With Abnormal Biochemical Laboratory Parameter Values by Maximum Grading|Among biochemical parameters tested were ALT, AST and CRE, graded by FDA toxicity grading for biochemistry parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.|From Day 7 up to Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC), which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2554694|NCT02753413|Primary|Number of Subjects With Abnormal Haematological Laboratory Values.|Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for LYM, NEU and PLT.|At Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2554695|NCT02753413|Primary|Number of Subjects With Abnormal Haematological Laboratory Values.|Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for LYM, NEU and PLT|At Day 7|The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2554696|NCT02753413|Primary|Number of Subjects With Abnormal Haematological Laboratory Values.|Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC.|At Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2554697|NCT02753413|Primary|Number of Subjects With Abnormal Haematological Laboratory Values.|Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC.|At Day 7|The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2554698|NCT02753413|Primary|Number of Subjects With Abnormal Biochemical Laboratory Values.|Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CRE]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0.|At Day 30|The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2554699|NCT02753413|Primary|Number of Subjects With Abnormal Biochemical Laboratory Values.|Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CRE]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0.|At Day 7|The analysis was performed on the Total Vaccinated Cohort (TVC) which included all subjects with study vaccine administration documented.|||Participants|||Count of Participants
2554701|NCT02753075|Secondary|Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4|Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (No Pain) to 10 (intense Pain). A reduction in the score is indicative of an improvement in sensitivity.|Baseline, Week 4|ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
2554702|NCT02753075|Secondary|Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 8|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.|Baseline, Week 8|ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||g||Full Range|Median
2554703|NCT02753075|Secondary|Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1, 2 and a Placebo Oral Rinse at Week 4|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.|Baseline, Week 4|ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||g||Full Range|Median
2554704|NCT02753075|Secondary|Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4|The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, Week 4|ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
2554705|NCT02753075|Secondary|Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8|The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, Week 8|ITT population included all participants who are randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
2554706|NCT02753075|Primary|Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8|The examiner assessed the participant's response to an evaporative air stimulus for each selected two teeth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, Week 8|Intent-to-treat (ITT) population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
2554707|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 24|All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554708|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 20|All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554976|NCT02750501|Secondary|Erythrocyte Composition (%) of DHA|Changes over time in erythrocyte composition (%) for total DHA in ITT population (n=39)|RELiZORB Treatment Period (Day 0-Day 90): 90 days|ITTT|||percentage of RBC composition||95% Confidence Interval|Least Squares Mean
2554709|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 16|All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554710|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 12|All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554711|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 at Week 8|All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554712|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 9 At Week 4|All the participants scored question No. 9 (Q9: on a scale of 1 to 10 how well can you tolerate sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =can easily tolerate and 10= cannot tolerate at all. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554713|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 24|All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
2554714|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week20|All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554715|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 16|All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554716|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 12|All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and impact they had on participant's everyday life.|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpa and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554717|NCT02752958|Primary|Change From Baseline in Mean Score DHEQ Section1 - Question (Q) No. 8 At Week 8|All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554718|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 8 At Week 4|All the participants scored question No. 8 (Q8: on a scale of 1 to 10 how bothered are you by any sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all bothered and 10= extremely bothered. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2555011|NCT02750267|Secondary|Distribution of Sensor and Meter Glucose Values (Median/Interquartile Range)|All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
2554719|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 24|All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554720|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 20|All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554721|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 16|All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554722|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 12|All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554723|NCT02752958|Primary|Change From Baseline in Mean Score of DHEQ Section1 - Question (Q) No. 7 At Week 8|All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554724|NCT02752958|Primary|Change From Baseline in Mean Score of Dentine Hyersensitivity Experience Questionnaire (DHEQ) Section1 - Question (Q) No. 7 At Week 4|All the participants scored question No. 7 (Q7: on a scale of 1 to 10 how intense are the sensations?) of section 1 of DHEQ on a scale of 1 to 10, where 1 =not at all intense and 10= worst imaginable. Section 1 of DHEQ consisted questions about participant's sensitive teeth and the impact they had on participant's everyday life.|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554725|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 24|All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554726|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 20|All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554727|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 16|All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2555012|NCT02750267|Secondary|Distribution of Sensor and Meter Glucose Values (Minimum)|All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
2554728|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 12|: All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554729|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 8|All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554730|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Effect on Life Overall (4 Item Total From Section 2 Questions 36 to 39) at Week 4|All participants scored first 4 questions present in Domain Effect on Life Overall of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not al all. Effect on Life Overall domain consisted of following questions Q36: Overall how much do the sensations in your teeth bother you? Q37: Overall, how much do the things you do to manage the sensations bother you? Q38: Overall, how much do the sensations in your teeth affect your quality of life? Q39: Overall, how much do the things you do to manage the sensations in your teeth affect your quality of life?|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554731|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 24|All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554732|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 20|All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554733|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 16|All participants scored one question present in Domain Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554734|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 12|All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554735|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 8|All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554775|NCT02752802|Secondary|Assessment of Incidence of Serious Adverse Device Effect for Subjects Treated With the DyeVert System During the Procedure.|To assess the incidence of Serious Adverse Device Effect for subjects treated with the DyeVert System during the procedure for treatment subjects only.|All data will be collected on the day of the procedure, over an average of 12 hours.|Only treatments subjects were analyzed for this endpoint.|||Number of Events|||Number
2554736|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Global Oral Health Rating (Response to Section 2 Question 35) at Week 4|All participants scored one question present in Domain Global oral health rating Global oral health rating of section 2 of the DHEQ using a 6-point scale, where, 6=Very poor, 5= poor, 4= Fair, 3= Good, 2=Very good, and 1= excellent. Global oral health rating domain consisted of following questionsQ35: overall how would you rate the health of your mouth, teeth and gums?|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessme|||Score on a scale||Standard Deviation|Mean
2554737|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 24|All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessme|||Score on a scale||Standard Deviation|Mean
2554738|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 20|All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554739|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questi 30 to 34) at Week 16|All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3 disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me fee damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpa and had at least one post - baseline DHEQ/clinical assessment.|||Score ona scale||Standard Deviation|Mean
2554740|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 12|All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554741|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 8|All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554742|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Identity (5 Item Total From Section 2 Questions 30 to 34) at Week 4|All participants scored first 4 questions present in Domain Identity of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of following questions Q30: I find it difficult to accept that I am a person who has these sensations in my teeth, Q31: Having these sensations in my teeth makes me feel different from others, Q32:Having these sensations in my teeth makes me feel old, Q33:Having these sensations in my teeth makes me feel damaged, Q34: Having these sensations in my teeth makes me feel as though I am unhealthy.|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2555013|NCT02750267|Secondary|Distribution of Sensor and Meter Glucose Values (Maximum)|All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
2554743|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 24|All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment|||Score on a scale||Standard Deviation|Mean
2554744|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 20|All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessme|||Score on a scale||Standard Deviation|Mean
2554745|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 16|All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessm|||Score on a scale||Standard Deviation|Mean
2554746|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 12|All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment|||Score on a Scale||Standard Deviation|Mean
2554747|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 8|All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment|||Score on a scale||Standard Deviation|Mean
2554776|NCT02752802|Secondary|Assessment of the Quality of Angiographic Images Between Groups|To assess the adequacy of the image quality. The proportion of images in which contrast opacification is deemed sufficient to evaluate the desired anatomical structures adequately will be compared between the DyeVert and control groups.|AlAll data will be collected on the day of the procedure, over an average of 12 hours.||||Images|Images||Count of Units
2554777|NCT02752802|Primary|Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group.|DyeVert is intended to reduce the total amount of contrast media (CM) administered during procedures requiring the injection of contrast media. Clinical evidence has demonstrated that CM can be toxic to the kidneys, leading to contrast induced nephropathy (CIN)|All data will be collected on the day of the procedure, over an average of 12 hours.||||ml||Standard Deviation|Mean
2554748|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Emotional Impact (8 Item Total From Section 2 Questions 22 to 29) at Week 4|All participants scored first 5 questions present in Domain Emotional Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of following questions Q22: I've been frustrated because I can't find anything that deals with the sensations I have in my teeth. Q23: I have been anxious that something I eat or drink might cause sensations in my teeth, Q24: The sensations in my teeth have been irritating, Q25: I have been annoyed with myself because I did something that I knew caused these sensation, Q26: I felt guilty because I might have contributed to the sensations I am having with my teeth, Q27: the sensations in my teeth have been annoying, Q28: The sensations in my teeth have been embarrassing, Q29: I have been anxious because of the sensations in my teeth.|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
2554749|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 24|All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554750|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 20|All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554751|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 16|All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score ona Scale||Standard Deviation|Mean
2554752|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 12|All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554753|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 8|All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554798|NCT02752256|Primary|Percentage of Participants With a rtPA Protocol Violation|Protocol violations can include any of the following recorded outcomes: inaccurate dosing or preparation at the outside hospital, uncontrolled blood pressure before and during the flight, unnecessary medication administration before and during the flight, intracranial bleeding, and angioedema|24 hours||||Participants|||Count of Participants
2554754|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Social Impact (5 Item Total From Section 2 Questions 17 to 21) at Week 4|All participants scored first 5 questions present in Domain Social Impact of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of following questions Q17: Because of sensations I take longer than others to finish meal, Q18: I have to be careful what I eat when I am with others because of sensation in my teeth, Q19: I hide the way I am eating with others because of sensations in my teeth, Q20: I am unable to fully take part in conversations because of sensations in my teeth., Q21: Going to dentist is hard for me because I know it is going to be painful as a result of sensations in my teeth.|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
2554755|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 24|All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554756|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 20|All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score ona scale||Standard Deviation|Mean
2554757|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 16|All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
2554758|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 12|All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554765|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 8|All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score ona scale||Standard Deviation|Mean
2554759|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 8|All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.|At Baseline and Week 8|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554760|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Adaptation (12 Item Total From Section 2 Questions 5 to 16) at Week 4|All participants scored first 4 questions present in Domain Adaptation of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of following questions Q5: I have to change the way I eat or drink certain things, Q6: I have to be careful how I breathe on a cold day, Q7: I have leave some cold foods/drinks to warm up before having them, Q8: I have to cool some foods/drinks down before I can have them, Q9: I have to cut up some fruits before eating, Q10: I have to wear scarf over my mouth on cold days, Q11: I have avoided very cold drinks/foods, Q12: I have avoided very hot drinks/foods, Q13: when eating some foods I have made sure they don't touch certain teeth, Q14: I have changed the way I brush, Q15: I bite some foods in small pieces, and Q16: there are other foods I have avoided.|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554761|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 24|All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.|At Baseline and Week 24|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
2554762|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 20|All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.|At Baseline and Week 20|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
2554763|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 16|All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.|At Baseline and Week 16|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
2554764|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 12|All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554774|NCT02752880|Primary|The Percentage Change in HbA1c Level From Baseline to 12 Weeks|The primary efﬁcacy endpoint was the percentage change in HbA1c levels from baseline to 12 weeks. The HbA1c level was measured by HPLC in the Department of Laboratory Medicine at Chang Gung Memorial Hospital.|12 weeks||||percentage change||Full Range|Median
2555014|NCT02750267|Secondary|Distribution of Sensor and Meter Glucose Values (Maximum, Minimum, Median, Interquartile Range, Mean, Standard Deviation)|All subjects have CGM and handheld glucose meter output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
2554766|NCT02752958|Primary|Change From Baseline in Mean DHEQ Score of Domain - Restrictions (4 Item Total From Section 2 Questions 1 to 4) at Week 4|All participants scored first 4 questions present in Domain Restriction of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of following questions Q1: Having sensation in my teeth takes a lot of the pleasure out of eating and drinking, Q2: there have been times when I can't finish my meal because of the sensations, Q3: It takes a long time to finish some foods and drinks because of sensations, and Q4: there have been times when I have had problems eating ice cream because if these sensations.|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a scale||Standard Deviation|Mean
2554767|NCT02752958|Primary|Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 24|All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).|At Baseline and Week 24|ITT population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment|||Score on a Scale||Standard Deviation|Mean
2554768|NCT02752958|Primary|Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 20|All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affect participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).|At Baseline and Week 20|ITT population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
2554769|NCT02752958|Primary|Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 16|All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affect participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).|At Baseline and Week 16|ITT population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score ona Scale||Standard Deviation|Mean
2554770|NCT02752958|Primary|Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 12|All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).|At Baseline and Week 12|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score ona Scale||Standard Deviation|Mean
2554771|NCT02752958|Primary|Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 8|All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).|At Baseline and Week 8|ITT population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
2554772|NCT02752958|Primary|Change From Baseline in Mean Total Score (34 Item Total From Section 2) of Dentine Hyersensitivity Experience Questionnaire (DHEQ) at Week 4|All participants scored first 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 had questions about the ways in which the sensations in the teeth affected participants in daily life. It was grouped into domains as follows: Restrictions (Section 2, Q1-4), Adaptation (Section 2, Q5-16), Social Impact (Section 2, Q17 to 21), Emotional Impact (Section 2, Q22 to 29), and Identity (Section 2, Q30 to 34).|At Baseline and Week 4|The intention to treat (ITT) population was the primary population of analysis, defined as all participants who received the study toothpaste and had at least one post - baseline DHEQ/clinical assessment.|||Score on a Scale||Standard Deviation|Mean
2554773|NCT02752880|Secondary|The Percentage Change in 2hPG From Baseline to Week 12|The secondary efﬁcacy endpoint was the percentage change in 2hPG level from baseline to 12 weeks by using enzymatic method in the Department of Laboratory Medicine at Chang Gung Memorial Hospital.|12 weeks||||percentage change||Full Range|Median
2555015|NCT02750267|Secondary|Percent of Time Sensor Glucose Readings Are >400 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
2554778|NCT02752776|Secondary|Patient Benefit Index (PBI) at Week 16 and Week 52|The questionnaire includes 23 items on patient-relevant therapy needs & benefits. The first part of the instrument, the 'Patient Needs Questionnaire' (PNQ), is filled in by the patient before therapy. A 5-step Likert scale (0='not important at all' to 4='very important') records the individual relevance of the different items to the patients. The second part, the PBQ, is filled in by the patient during or after therapy. It comprises the same items as the PNQ, but in contrast, the patients evaluate the extent to which the treatment needs have been fulfilled by therapy (scaled from 0='treatment did not help at all' to 4='treatment helped a lot'). In addition, the Likert scale contains the option 'does not apply to me' in the PNQ & the option 'did not apply to me' in the PBQ. The needs prior to treatment (PNQ) & the benefits achieved by treatment (PBQ) are converted to a weighted index value, the PBI in the narrower sense. PBI can have a value from 0='no benefit' to 4='maximal benefit'.|Week 16 and Week 52|Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2554779|NCT02752776|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) Scale Scores at Week 16 and Week 52|Treatment Satisfaction Questionnaire for Medication (TSQM) is general measure for treatment satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0—100 scale. Higher summary scores indicate better satisfaction with study drug.|16 and 52 weeks|Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2554780|NCT02752776|Secondary|Absolute Change From Baseline in Numeric Rating Scale (NRS) at Week 16 and Week 52|Selfadministered 11-point numeric rating scales (NRS, 0-10) were used to evaluate the patients' assessment of their current pain, itching & scaling. Respondents answered the following questions for the assessment: Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours?; Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours?; & Scaling: Overall, how severe was your psoriasis related scaling over the past 24 hours? Patients had to rate their pain, itching, & scaling from 0 to 10 (11-point scale), with the understanding that the 0 represents the absence or null end of the pain, itching, or scale intensity (i.e. no pain, itching or scaling) & the 10 represents the other extreme of pain, itching, or scaling intensity (i.e. pain, itching or scaling as bad as it could be). The number that the patient selected represents his or her intensity score in the respective category.|16 and 52 weeks|Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2554781|NCT02752776|Secondary|Absolute Change From Baseline in HAQ-DI at Week 16 and Week 52|"The HAQ-DI (Health Assessment Questionnaire - Disability Index) assesses a patient's level of functional ability & includes questions on fine movements of the upper extremity, locomotor activities of the lower extremity & activities that involve both upper & lower extremities. There are 20 items in 8 categories of functioning including dressing & grooming, arising, eating, walking, hygiene, reach, grip & usual activities. The stem of each item asks over the past week, Are you able to... perform a particular task. Each item is scored on a 4-point scale from 0 to 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) & unable to do (3). The HAQ-DI also includes questions about the use of 'aids or devices' & aid from other people to supplement the answers given to the 20 items. Total scores were calculated by averaging all scores and ranging from 0 (best) to 3 (worst). Subtracting the baseline value from the week 16 or 52 values results in the change."|Week 16 and Week 52|Full Analysis set - subset of patients with psoriatic arthritis at baseline: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2554782|NCT02752776|Secondary|Absolute Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) at Week 16 and Week 52|"A visual analogue scale (VAS) was used within the EQ-5D. This scale recorded the respondent's self-rated health on a vertical 20-cm VAS where the endpoints were labeled best imaginable health state and worst imaginable health state. This resulted in a numeric value set ranging from 0 (=worst imaginable health state) up to 100 (=best imaginable health state)."|Week 16, Week 52|Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2554783|NCT02752776|Secondary|Absolute Change From Baseline in EQ-5D-5L Crosswalk Index at Week 16 and Week 52|The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort & anxiety/depression. The 5 dimensions have 5 response levels scored from 1 (best) to 5 (worst). The first 3 dimensions have the response levels lasting from no problems, slight problems, moderate problems, severe problems to unable; the last 2 dimensions have the 5 response levels lasting from no, slight, moderate, severe to extreme. From these 5 dimensions the Crosswalk-index is calculated by concatenating the responses & choosing the corresponding country specific index value from the EQ-5D-5L_Crosswalk_Index_Value_Calculator.v2 excel file (https://euroqol.org/eq-5d-instruments/eq-5d-5labout/valuation-standard-value-sets/crosswalk-index-value-calculator/). This calculated participant-level index scores from -0.654 (worst health) to 1.0 (best health).|Week 16, Week 52|Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.|||scores on a scale||Standard Deviation|Mean
2554799|NCT02752074|Secondary|Formation of Anti-pembrolizumab Antibodies|Evaluate the measurement of anti-drug antibodies (ADA).|Through up to 30 days after the end of treatment, up to 25 months|Data was not available nor the analysis completed for the incidence of ADA to pembrolizumab, because all participants were unblinded; sample collections and the planned analysis for ADA were discontinued after the interim analysis.||||||
2554800|NCT02752074|Secondary|Volume of Distribution (V) of Pembrolizumab||Through up to 30 days after the end of treatment, up to 25 months|The data was not available nor was the analysis completed for pembrolizumab V, because participants were unblinded and sample collections and the planned analysis for pembrolizumab V were discontinued after the interim analysis.||||||
2554801|NCT02752074|Secondary|Clearance (CL) of Pembrolizumab||Through up to 30 days after the end of treatment, up to 25 months|The data was not available nor was the analysis completed for pembrolizumab CL, because participants were unblinded and sample collections and the planned analysis for pembrolizumab CL were discontinued after the interim analysis.||||||
2554784|NCT02752776|Secondary|Percentage of Participants With PASI 50, PASI 75, PASI 90, PASI 100 or IGA Mod 2011 0/1 Response at Week 16 and 52|PASI is a combined assessment of lesion severity & affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself & scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), & severity is estimated by clinical signs, erythema, induration & desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 & 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 16, Week 52|Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.|||Percentage of participants||95% Confidence Interval|Number
2554785|NCT02752776|Secondary|Percentage of Participants in Each DLQI Score Category at Week 16 and Week 52|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment."|52 weeks|Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.|||Percentage of participants||95% Confidence Interval|Number
2554786|NCT02752776|Secondary|Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 52|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment."|52 weeks|Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.|||Percentage of participants||95% Confidence Interval|Number
2554787|NCT02752776|Primary|Percentage of Participants With a Dermatology Life Quality Index 0/1 (DLQI 0/1) Response at Week 16|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment."|16 weeks|Full Analysis set: The Full Analysis set included all patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment.|||Percentage of participants||95% Confidence Interval|Number
2554788|NCT02752633|Primary|Urinary 2,8-dihydroxyadenine Excretion||0, 14 and 28 days||||mg/24-h||Full Range|Median
2554789|NCT02752490|Secondary|Number of Participants With Clinical Chorioamnionitis||during labor||||Participants|||Count of Participants
2554790|NCT02752490|Secondary|Number of Participants Who Received Intrauterine Resuscitation Other Than Administration of Maternal Oxygen|"Intrauterine resuscitation includes administration of terbutaline, amnioinfusion, cessation of oxytocin, and intravenous (IV) fluid boluses. In this measure, the number of participants who received any of these 5 procedures will be reported in aggregate as the number of participants who received intrauterine resuscitation other than administration of maternal oxygen."|during labor||||Participants|||Count of Participants
2554791|NCT02752490|Secondary|Total Duration of Maternal Oxygen Use||during labor|For this outcome measure, the number of participants analyzed is not equal to the number of participants who started or completed the study because not all participants received oxygen. All who received oxygen were analyzed for this measure.|||minutes||Inter-Quartile Range|Median
2554792|NCT02752490|Secondary|Number of Participants Whose Infants Were Admitted to the Neonatal Intensive Care Unit (NICU)||from time of birth to discharge from hospital (an average of 2-4 days)||||Participants|||Count of Participants
2554793|NCT02752490|Secondary|Number of Participants Whose Infants Had an Apgar Score < 7 at 5 Minutes|The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. A score of 10 is very unusual, since almost all newborns lose 1 point for blue hands and feet, which is normal for after birth.|5 minutes after birth||||Participants|||Count of Participants
2554794|NCT02752490|Secondary|Number of Participants Who Delivered by Cesarean for Non-reassuring Fetal Status||at time of birth||||Participants|||Count of Participants
2554795|NCT02752490|Secondary|Number of Participants With Umbilical Artery pH (Potential Hydrogen) < 7.10 at Birth||at time of birth|For this outcome measure, the number of participants analyzed is not equal to the number of participants who started or completed the study because each participant's provider determines whether umbilical artery pH is analyzed, and thus, umbilical artery pH is not collected for every participant in the study.|||Participants|||Count of Participants
2554796|NCT02752490|Primary|Number of Participants Who Delivered by Cesarean||at time of birth||||Participants|||Count of Participants
2554797|NCT02752256|Secondary|Average Time to rtPA||24 hours||||Minutes||Standard Deviation|Mean
2554802|NCT02752074|Secondary|Apparent Volume of Distribution (Vd/F) of Epacadostat|Apparent volume of distribution after administration.|Through up to 30 days after the end of treatment, up to 25 months|All randomized participants enrolled in the Epacadostat arm currently with melanoma.|||Liter||Standard Deviation|Mean
2554804|NCT02752074|Secondary|Duration of Response (DOR)|Defined as the time from the earliest date of qualifying response until earliest date of disease progression, per RECIST v1.1, or death from any cause, whichever comes first. Includes participants with complete response or partial response.|Assessed every 9 weeks for duration of study participation which is estimated to be 24 months|Intent to Treat (ITT) population: consists of all randomized participants.|||months||Full Range|Median
2554805|NCT02752074|Secondary|Safety and Tolerability, as Assessed by Percentage of Participants With Adverse Events|Safety and tolerability, as assessed by percentage of participants with adverse events and changes in laboratory parameters.|Through up to 90 days after end of treatment, up to 27 months|All Subjects as Treated (ASaT): All participants who were enrolled and took at least 1 dose of study medication.|||Participants|||Count of Participants
2554806|NCT02752074|Secondary|Objective Response Rate (ORR)|Objective response rate (ORR) is defined as the percentage of the participants in the analysis population who have a confirmed complete response (CR) or partial response (PR) based on RECIST 1.1 by independent central review.|Assessed every 9 weeks for duration of study participation which is estimated to be 24 months|Intent to Treat (ITT) population: consists of all randomized participants.|||Participants|||Count of Participants
2554807|NCT02752074|Primary|Overall Survival (OS) Rate at 6 Months|Defined as time from date of randomization to date of death due to any cause. OS was calculated using product-limit (Kaplan-Meier) method for censored data.|Assessed every 9 weeks of study participation which is estimated to be 24 months. The OS rate at Month 6 was calculated.|Intent to Treat (ITT) population: consists of all randomized participants. OS was analyzed at the time of primary analysis at 6 months. An overall OS was not conducted after the primary analysis since all participants were unblinded, transitioned to monotherapy pembrolizumab and survival follow-up was discontinued.|||percent probability||95% Confidence Interval|Median
2554808|NCT02752074|Primary|Progression-free Survival|Progression-free survival, defined as the time from date of randomization until the earliest date of disease progression, as determined by independent central review of objective radiographic disease assessments per RECIST 1.1, or death from any cause, whichever comes first.|Assessed every 9 weeks for duration of study participation which is estimated to be 24 months or data cut-off 08Jan2018|Intent to Treat (ITT) population: consists of all randomized participants.|||months||95% Confidence Interval|Median
2554809|NCT02752048|Secondary|Mean Change From Baseline in Time to up and go (TUG)|This test will assess the extent of the subject's composite mobility, including standing up, walking, repositioning the body, and balancing.|baseline, and 24 weeks||||second||Standard Deviation|Mean
2554810|NCT02752048|Secondary|Mean Change From Baseline in Time to Walk/Run for 10meters|The time required for the subject to run or walk as quickly as possible a 10 m-wide passage with marks affixed on the floor will be evaluated.|baseline, and 24 weeks||||second||Standard Deviation|Mean
2554811|NCT02752048|Secondary|Mean Change From Baseline in Time to Rise From the Floor|The time required for the subject to rise from a supine position on the floor as quickly as possible will be evaluated.|baseline, and 24 weeks||||second||Standard Deviation|Mean
2554812|NCT02752048|Primary|Mean Change From Baseline to 24 Weeks in the 6-minute Walk Distance (6MWD)|The distance the subject can walk as fast as possible in 6 minutes will be evaluated.|baseline, 24 weeks||||meter||Standard Deviation|Mean
2554813|NCT02751983|Secondary|Columbia Suicide-Severity Rating Scale (Used to Assess Change)|Clinician-administered interview that assesses suicidal ideation and behavior. Will be examined as a candidate outcome measure for a future efficacy trial. Suicidal ideation intensity scores can range from 0 to 25 with higher scores indicating a greater intensity of suicidal ideation. Suicidal ideation intensity scale scores are reported.|Pre-treatment, and one- and three-month follow-ups|The number of participants analyzed in row two and three differ from row one because the results are from different time points and some participants were lost to follow up.|||units on a scale||95% Confidence Interval|Mean
2554814|NCT02751983|Secondary|PROMIS Short Form v2.0- Satisfaction With Social Roles and Activities 8a (Used to Assess Change)|Self-report measure that assesses satisfaction with respondents' ability to perform various social activities. Will be examined as a candidate outcome measure for a future efficacy trial. Scale scores range from 8 to 40 with higher scores indicating greater satisfaction with ability to perform social activities.|Pre-treatment, and one- and three-month follow-ups|The number of participants analyzed in row two and three differ from row one because the results are from different time points and some participants were lost to follow up.|||units on a scale||95% Confidence Interval|Mean
2554815|NCT02751983|Secondary|PROMIS Global Short Form v1.1 (Used to Assess Change)|Self-report measure assessing multiple domains of health. The scale yields two subscales: Global Physical Health and Global Mental Health. Global Mental Health will be examined as a candidate outcome measure for a future efficacy trial. The Global Mental Health sum score can range from 4 to 20, with higher scores indicating greater mental health.|Pre-treatment, and one- and three-month follow-ups|The number of participants analyzed in row two and three differ from row one because the results are from different time points and some participants were lost to follow up.|||score on a scale||95% Confidence Interval|Mean
2554816|NCT02751983|Secondary|Inventory of Psychosocial Functioning (Used to Assess Change)|Self-report measure that assesses impairment within the last 30 days across a spectrum of psychosocial domains. Will be examined as a candidate outcome measure for a future efficacy trial. Response options range from 0 = never to 6 = always. The measure yields a mean score for the total scale. Higher scores indicate less functional impairment. The total scale score is reported.|Pre-treatment, and one- and three-month follow-ups|The number of participants analyzed in row two and three differ from row one because the results are from different time points and some participants were lost to follow up.|||units on a scale||95% Confidence Interval|Mean
2554836|NCT02751424|Secondary|Part 2- Ae of GSK3342830 in Urine|Ae defines as the amount of drug GSK3342830, excreted in urine. These were collected in opaque bottles on Day 1 and Day 15 at (Pre-dose, 0 to 8 and 8 to 24 hrs post-dose). The untransformed values for Ae have been presented.|Day 1 and Day 15 at (Pre-dose, 0 to 8 and 8 to 24 hrs post-dose)|PK Parameter Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||milligram||Standard Deviation|Mean
2555016|NCT02750267|Secondary|Percent of Time Sensor Glucose Readings Are >250 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|68 hours||||percentage of time above 250 mg/dL||Standard Deviation|Mean
2554817|NCT02751983|Secondary|Valued Living Questionnaire (Used to Assess Change)|"Self-report measure that assesses participants' life values as well as the perceived consistency with which they have been living according to their values. Will be examined as a candidate outcome measure for a future efficacy trial. The reported composite score accounts for both importance and consistency (mean of the products of importance and consistency scores within each domain) to quantify the extent to which one is contacting values in everyday life. Scores can range from 1 to 100 with higher scores indicating greater contact with values in everyday life, which is generally considered desirable and a sign of good functioning."|Pre-treatment, and one- and three-month follow-ups|The number of participants analyzed in row two and three differ from row one because the results are from different time points and some participants were lost to follow up.|||score on a scale||95% Confidence Interval|Mean
2554818|NCT02751983|Secondary|Outcome Questionnaire 45.2 (OQ-45)|"The Outcome Questionnaire 45.2 is a 45-item self-report scale that assesses symptom distress, interpersonal relationships, and social role (functioning in the workplace, school, and home) for the past week. The OQ-45 total score ranges from 0-180 with higher scores indicating greater distress and impairment. Scores of 63 or more generally indicate symptoms of clinical significance and changes of 14 points or more are typically considered a reliable change."|Pre-treatment, One-Month Follow-Up, Three-Month Follow-Up|The number of participants analyzed in row two and three differ from row one because the results are from different time points and some participants were lost to follow up.|||score on a scale||95% Confidence Interval|Mean
2554819|NCT02751983|Primary|Reasons for Termination (Client and Therapist Versions)|Self-report scale which assesses the impact of 19 common reasons why patients terminate therapy. Will be used to assess treatment acceptability. These participants reported reasons for termination of ACT, but this did not produce quantitative data.|Post-treatment (0-7 days after treatment termination)|Data reflects those who terminated the intervention.|||Participants|||Count of Participants
2554820|NCT02751983|Primary|Narrative Evaluation of Intervention Interview|Semi-structured interview assessing each participants' perspective of the impact of the intervention, helpful and unhelpful components, and comparison to other interventions. Will be used to assess acceptability and inform revisions to the treatment manual. Qualitative Thematic Analysis was conducted. There are no objective data to report from this interview. Please contact the PI for reference to a manuscript with the qualitative results.|Post-treatment (0-7 days after treatment completion)|Post-treatment data were collected from participants who engaged in at least one ACT for Life session. 2 of the 35 ACT participants discharged from the hospital prior to receiving any treatment. 3 participants discharged prior to post-treatment assessment and were lost to follow-up.|||participants analyzed|||Number
2554821|NCT02751983|Primary|Client Satisfaction Questionnaire - 8|Self-report measure that will be used to assess participants' satisfaction with ACT for Life. Scale scores range from 8 to 32 with higher scores indicating greater satisfaction. For the purposes of the current study scores greater than or equal to 24 were considered acceptable. The number of participants scoring ≥ 24 is reported below.|Post-treatment (0-7 days after treatment completion)|Post-treatment data were collected from participants who engaged in at least one ACT for Life session. 2 of the 35 ACT participants discharged from the hospital prior to receiving any treatment. 3 participants discharged prior to post-treatment assessment and were lost to follow-up.|||Participants|||Count of Participants
2554822|NCT02751879|Secondary|Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif®|Different reasons for starting dose with modified dose that is dose other than recommended 40 mg once daily.|From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.|FAS|||Percentage of patients (%)|||Number
2554823|NCT02751879|Secondary|Percentage of Patients With a Modified Starting Dose of Gi(l)Otrif®|Percentage of patients with a modified starting dose that is dose other than the recommended 40 mg daily of Gi(l)otrif® has been calculated to assess this outcome measure.|From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.|FAS|||Percentage of patients (%)|||Number
2554824|NCT02751879|Primary|Time to Progression With Gi(l)Otrif®|Time to progression was calculated from the date of first dose of Gi(l)otrif® treatment to the earliest date of documented progression (clinical, radiographic or both clinical/radiographic progression) or tumour-related death, whatever occurred first.|From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.|FAS|||Months||95% Confidence Interval|Median
2554825|NCT02751879|Primary|Time on Treatment With Gi(l)Otrif®|Time on treatment with Gi(l)otrif® in real-world setting has been calculated in this assessment. Time on treatment refers to time to treatment failure with Gi(l)otrif®|From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.|FAS|||Months||95% Confidence Interval|Median
2554826|NCT02751879|Primary|Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class.|An adverse drug reaction (ADR) is defined as a response to a medicinal product which is noxious and unintended. Grade 1, Grade 2, Grade 3 and Grade 4 ADR severity classes were considered for assessment of this outcome.|From signing the informed consent onwards until the end of the study, up to 104 weeks.|Full Analysis set (FAS): All registered patients with informed consent (as applicable with local regulations) and at least one administration of Gi(l)otrif®.|||Percentage of patients (%)|||Number
2554827|NCT02751450|Secondary|Change From Baseline in Tactile Threshold on Day 3|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline to Day 3|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||g||Standard Deviation|Mean
2554977|NCT02750501|Secondary|Changes in Plasma Concentration Total DHA+EPA|Changes in plasma concentration total DHA+EPA from baseline (Day 0 to Day 90).|RELiZORB Treatment Period (Day 0-Day 90): 90 days|All subjects who entered the RELiZORB Treatment period, received at least one treatment with the study device and completed the study.|||percentage of total plasma concentration||95% Confidence Interval|Least Squares Mean
2554828|NCT02751450|Secondary|Change From Baseline in Tactile Threshold Post First Treatment by Direct Application|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline to 60 seconds post first treatment|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||g||Standard Deviation|Mean
2554829|NCT02751450|Secondary|Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline to 60 seconds post first treatment|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||Score on a Scale||Standard Deviation|Mean
2554830|NCT02751450|Primary|Change From Baseline in Schiff Sensitivity Score on Day 3|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline to Day 3|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||Score on a scale||Standard Deviation|Mean
2554831|NCT02751424|Secondary|Part 2: Trough Plasma Concentrations at the End of the Dosing Interval (Ctau) to Assess the Achievement of Steady-state of GSK3342830 After Administration of Repeat IV Doses, as Data Permit|Sampling was done at Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 h post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 h post-dose at Day 15. The untransformed values for Ctau have been presented.|Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 h post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 h post-dose at Day 15|PK Parameter Population|||microgram per milliliter||Standard Deviation|Mean
2554832|NCT02751424|Secondary|Part 2: Steady-state Ratio (Rss) of GSK3342830 to Assess Time Invariance, as Data Permit|Sampling was done at Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 h post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 h post-dose at Day 15. Since the study was terminated early, data is only available for one dose level for Part 2. Some subjects have only partial data and were not dosed on Day 15.|Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 h post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 h post-dose at Day 15|PK Parameter Population|||Ratio||Standard Deviation|Mean
2554833|NCT02751424|Secondary|Part 2: Observed Accumulation Ratio (Ro) Based on AUC and Cmax of GSK3342830 After Administration of Repeat IV Doses, as Data Permit|The accumulation ratio has been reported. Sampling was done at Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 h post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 h post-dose at Day 15. Data cannot be summarized because only 1 dose level studied so dose proportionality analysis cannot be performed as no comparison can be conducted.|Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 h post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 h post-dose at Day 15|PK Parameter Population.|||Ratio||Standard Deviation|Mean
2554834|NCT02751424|Secondary|Part 2: Dose Proportionality: AUC (0-tau)|Blood samples were collected at Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hr post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hr post-dose at Day 15. Data cannot be summarized because only 1 dose level studied so dose proportionality analysis cannot be performed as no comparison can be conducted.|Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hr, post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hr post-dose at Day 15|PK Parameter Population||||||
2554835|NCT02751424|Secondary|Part 2: AUC From Time Zero to Last Measurable Concentration AUC (0- Tau)|It was defined as Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the time of the last measureable concentration. Blood samples were collected on Day 1 at indicated timepoints pre-dose, 0.5 hr, 1hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr,3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr 24 hr, 36 hr and 48 hr post-dose. Log untransformed values for AUC (0 to tau) have been presented.|Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose|PK Parameter Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||hour*microgram per milliliter||Standard Deviation|Mean
2555017|NCT02750267|Secondary|Percent of Time Sensor Glucose Readings Are >180 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|68 hours||||percentage of time above 180 mg/dL||Standard Deviation|Mean
2554837|NCT02751424|Secondary|Part 2-CLr of GSK3342830 in Urine|The renal CLr is a PK measure of volume of plasma from which the drug is removed per unit time.These were collected in opaque bottles on Day 1 and Day 15 at (Pre-dose, 0 to 8 and 8 to 24 hrs post-dose). The untransformed values for CLr have been presented.|Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 h post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 h post-dose at Day 15|PK Parameter Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Liter per hour||Standard Deviation|Mean
2554838|NCT02751424|Secondary|Part 2- Trough Concentration (Ctau)|Blood samples were collected on Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 h post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 h post-dose at Day 15. The untransformed values for Ctau have been presented.|Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 h post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 h post-dose at Day 15|PK Parameter Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||microgram per milliliter||Standard Deviation|Mean
2554839|NCT02751424|Secondary|Part 2-Urinary Excretion Ratio Relative to Dose Feu (t1-t2) of GSK3342830|The Feu has been reported from 0 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 48 hrs. These were collected in opaque bottles at pre-dose (within a 24-hr period before dosing, may begin on Day -1) and 0 to 4, 4 to 8, 8 to 12, 12 to 24, and 24 to 48 hrs post-dose.|Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hr post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hr post-dose at Day 15|PK Parameter Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|||Percentage of excretion ratio||Standard Deviation|Mean
2554840|NCT02751424|Secondary|Part 2- Vss of Distribution of GSK3342830 in Plasma|Vss reflects the actual blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces. The blood samples of 3 mL were collected at Day 1 at pre-dose (15 minutes) and 0.5 hr, 1 hr (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hrs after start of infusion. Single pre-dose samples on mornings of Days 3, 6, 9, 12, and 13. Serial samples (Day 15) time points: pre-dose (15 minutes) and 0.5 hr, 1 (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hrs after start of infusion.|Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 h post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 h post-dose at Day 15|PK Parameter Population|||Liter||Standard Deviation|Mean
2554841|NCT02751424|Secondary|Part 2-Total CL of GSK3342830 in Plasma|The systemic CL is a PK measure of volume of plasma from which the drug is removed per unit time. The blood samples of 3 mL were collected at Day 1 at pre-dose (15 minutes) and 0.5 hr, 1 hr (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hrs after start of infusion. Single pre-dose samples on mornings of Days 3, 6, 9, 12, and 13. Serial samples (Day 15) time points: pre-dose (15 minutes) and 0.5 hr, 1 (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hrs after start of infusion.|Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hr post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hr post-dose at Day 15|PK Parameter Population|||Liter per hour||Standard Deviation|Mean
2554842|NCT02751424|Secondary|Part 2-Terminal t1/2 of GSK3342830 in Plasma|t ½ is defined as the time required by the drug to reduce to half its quantity. Blood samples were collected at Day 1 at pre-dose (15 minutes) and 0.5 hr, 1 hr (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hrs after start of infusion. Single pre-dose samples on mornings of Days 3, 6, 9, 12, and 13. Serial samples (Day 15) time points: pre-dose (15 minutes) and 0.5 hr, 1 (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hrs after start of infusion.|Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 h post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 h post-dose at Day 15|PK Parameter Population|||hour||Standard Deviation|Mean
2554843|NCT02751424|Secondary|Part 2-Tmax of GSK3342830|Tmax was defined as time required to achieve Cmax for drug GSK3342830, in plasma. It was collected at Day 1 at pre-dose (15 minutes) and 0.5 hr, 1 hr (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hrs after start of infusion. Single pre-dose samples on mornings of Days 3, 6, 9, 12, and 13. Serial samples (Day 15) time points: pre-dose (15 minutes) and 0.5 hr, 1 (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hrs after start of infusion.|Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 h post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 h post-dose at Day 15|PK Parameter Population|||hour||Standard Deviation|Mean
2554844|NCT02751424|Secondary|Part 2-Cmax of GSK3342830|Cmax was defined as the maximum concentration of drug GSK3342830, in plasma. It was collected at Day 1 at pre-dose (15 minutes) and 0.5 hr, 1 hr (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hrs after start of infusion. Single pre-dose samples on mornings of Days 3, 6, 9, 12, and 13. Serial samples (Day 15) time points: pre-dose (15 minutes) and 0.5 hr, 1 (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hrs after start of infusion.|Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hr, post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hr post-dose at Day 15|PK Parameter Population.|||microgram per milliliter||Standard Deviation|Mean
2554845|NCT02751424|Secondary|Part 2-AUC (0-inf) of GSK3342830|AUC (0-inf), was defined as AUC extrapolated from time zero to infinity Day 1 at pre-dose (15 minutes) and 0.5 hr, 1 hr (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hrs after start of infusion. Single pre-dose samples on mornings of Days 3, 6, 9, 12, and 13. Serial samples (Day 15) time points: pre-dose (15 minutes) and 0.5 hr, 1 (end of infusion), 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hrs after start of infusion. The untransformed values for AUC(0-inf) have been presented.|Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hr post-dose at Day 1. Pre-dose on Day 3, 6, 9, 12, and 13. Pre-dose, and 0.5, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, and 8 hr post-dose at Day 15|PK Parameter Population|||hour *microgram per milliliter||Standard Deviation|Mean
2554846|NCT02751424|Secondary|Part 1:Dose Proportionality: Cmax|Blood samples were collected at Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose. The data for estimate slope for log dose, has been reported.|Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose|PK Parameter Population|||microgram per milliliter||Standard Error|Mean
2554847|NCT02751424|Secondary|Part 1:Dose Proportionality: AUC (0-inf)|Blood samples were collected at Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48 hr post-dose. The data for estimate slope for log dose, has been reported.|Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose|PK Parameter Population|||hour*microgram per milliliter||Standard Error|Mean
2554848|NCT02751424|Secondary|Part 1:Dose Proportionality: AUC (0-t)|Blood samples were collected at Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose. Dose proportionality was assessed for AUC(0-inf) and Cmax after single dose administration. AUC(0-inf) was selected as the AUC exposure measure as it is the default AUC parameter for single dose administration and the observed data permitted its calculation.|Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose|PK Parameter Population||||||
2554849|NCT02751424|Secondary|Part 1-Amount Excreted in Urine (Ae) of GSK3342830 in Urine|Ae is defined as amount of drug GSK3342830, excreted in urine. Urine samples were collected pre-dose (within a 24-hr period before dosing, may begin on Day -1) and 0 to 4, 4 to 8, 8 to 12, 12 to 24, and 24 to 48 hrs post-dose. Log untransformed values for Ae have been presented.|Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose|PK Parameter Population|||Milligram||Standard Deviation|Mean
2554850|NCT02751424|Secondary|Part 1-Renal Clearance (CLr) of GSK3342830 in Urine|The renal clearance (CLr) is a PK measure of volume of drug is removed per unit time. Urine samples were collected at indicated timepoints pre-dose and post dose. This part 1 phase of the study comprised of single dosing of the participants. Log untransformed values for CLr have been presented.|Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose|PK Parameter Population|||Liter per hour||Standard Deviation|Mean
2554851|NCT02751424|Secondary|Part 1-Urinary Excretion Ratio Relative to Dose (Feu [t1-t2]) of GSK3342830|Urine samples were collected at indicated timepoints pre-dose and post dose. The Feu has been reported from 0 to 4, 4 to 8, 8 to 12, 12 to 24 and 24 to 48 hrs. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data is not available. The standard deviation could not be calculated as only single participant was present. Log untransformed values for Feu (t1-t2) have been presented.|Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48 hr post-dose|PK parameter population|||Percentage of excretion ratio||Standard Deviation|Mean
2554852|NCT02751424|Secondary|Part 1-Steady-state Volume (Vss) of Distribution of GSK3342830 in Plasma|Vss reflects the actual blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces. Blood samples were collected on Day 1 at indicated timepoints pre-dose, 0.5 hr, 1hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr,3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr 24 hr, 36 hr and 48 hr post-dose. This part 1 phase of the study comprised of single dosing of the participants. Log untransformed values for Vss have been presented.|Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48 hr post-dose|PK Parameter Population|||Liter||Standard Deviation|Mean
2554853|NCT02751424|Secondary|Part 1-Total Systemic Clearance (CL) of GSK3342830 in Plasma|The systemic CL is a PK measure of volume of plasma from which the drug is removed per unit time. Blood samples were collected on Day 1 at indicated timepoints pre-dose, 0.5 hr, 1hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr,3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr 24 hr, 36 hr and 48 hr post-dose. This part 1 phase of the study comprised of single dosing of the participants. Log untransformed values for CL have been presented.|Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48 hr post-dose|PK Parameter Population|||Liter per hour||Standard Deviation|Mean
2554854|NCT02751424|Secondary|Part 1-Terminal Elimination Half-life (t1/2) of GSK3342830 in Plasma|t ½ is defined as the time required by the drug to reduce to half its quantity. Blood samples were collected on Day 1 at indicated timepoints pre-dose, 0.5 hr, 1hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr,3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr 24 hr, 36 hr and 48 hr post-dose. This part 1 phase of the study comprised of single dosing of the participants. Log untransformed values for t1/2 have been presented.|Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48 hr post-dose|PK Parameter Population|||hour||Standard Deviation|Mean
2554855|NCT02751424|Secondary|Part 1-Time to Maximum Plasma Concentration (Tmax) of GSK3342830|Tmax was defined as time required to achieve Cmax for drug GSK3342830, in plasma. Blood samples were collected on Day 1 at indicated timepoints pre-dose, 0.5 hr, 1hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr,3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr 24 hr, 36 hr and 48 hr post-dose. This part 1 phase of the study comprised of single dosing of the participants. Log untransformed values for tmax have been presented.|Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose|PK Parameter Population.|||hour||Standard Deviation|Mean
2554856|NCT02751424|Secondary|Part 1-Maximum Plasma Concentration (Cmax) of GSK3342830|Cmax was defined as the maximum concentration of drug GSK3342830, in plasma. Blood samples were collected on Day 1 at indicated timepoints pre-dose, 0.5 hr, 1hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr,3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr 24 hr, 36 hr and 48 hr post-dose. This part 1 phase of the study comprised of single dosing of the participants. Log untransformed values for Cmax have been presented.|Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48 hr post-dose|PK Parameter Population|||Microgram per milliliter||Standard Deviation|Mean
2554857|NCT02751424|Secondary|Part 1-AUC Pre Dose to Infinite (Inf) Time (AUC [0-inf]) of GSK3342830|AUC (0-inf) is defined as AUC extrapolated from time zero to infinity. Blood samples were collected on Day 1 at indicated timepoints pre-dose, 0.5 hr, 1hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr,3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr 24 hr, 36 hr and 48 hr post-dose. This part 1 phase of the study comprised of single dosing of the participants. Log untransformed values for AUC (0-inf) have been presented.|Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48hr post-dose|PK Parameter Population|||hour *microgram per milliliter||Standard Deviation|Mean
2554858|NCT02751424|Secondary|Part 1-Area Under the Plasma Concentration (AUC) From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Across All Treatments AUC(0-t) for GSK3342830|AUC (0-t) is defined as AUC from time zero to the last quantifiable concentration after dosing. Blood samples were collected on Day 1 at indicated timepoints (pre-dose, 0.5 hr, 1hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr,3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr 24 hr, 36 hr and 48 hr post-dose. The Part 1 phase of the study comprised of single dosing of participants. Log untransformed values for AUC (0-t) have been presented.|Day 1 (pre-dose, 0.5 hr, 1 hr, 1.25 hr, 1.5 hr, 2 hr, 3 hr, 3.5 hr, 4 hr, 4.5 hr, 5 hr, 6 hr, 8 hr, 10 hr, 12 hr, 16 hr, 24 hr, 36 hr, 48 hr post-dose|The Pharmacokinetic (PK) Parameter Population included all participants in the PK population for whom valid and evaluable PK parameters were derived. PK Population is defined as all participants who received at least 1 dose of GSK3342830 and have evaluable PK data for GSK3342830.|||hour *microgram per milliliter||Standard Deviation|Mean
2554859|NCT02751424|Primary|Part 2: Number of Participants With Vital Signs of PCI|The vitals for systolic, diastolic blood pressure, heart rate, respiratory rate and temperature were taken in a semi-supine position, where the participant had rested in the same position for atleast 5 minutes. The number of participants with vital values, of PCI were reported. These were collected from Day 1 to Day 16. Assessments were done within 1 hr before the start of infusion (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, and 12 hrs after the start of infusion on Days 1 and 15, within 1 hr before the start of the morning infusion and on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and in the morning on Day 16.|Up to Day 16|Safety population|||Participants|||Number
2554860|NCT02751424|Primary|Part 1: Number of Participants With Vital Signs of Potential Clinical Importance (PCI)|The vital sign includes systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and temperature which were measured in a semi-supine position, where the participant had rested in the same position for at least 5 minutes. The number of participants with vital values, of PCI were reported. These were collected on Day 1 at pre-dose, 0.5 hr, 1 hr, 1.5 hr, 2, 3, 4, 6, 12 and 24 hr, Day 2 (36 hr) and Day 3 (48 hr) during Part 1 (single dose escalation phase) of the study.|Up to Day 3|Safety population|||Participants|||Number
2554861|NCT02751424|Primary|Part 2: Number of Participants With ECG Parameters of PCI|Triplicate 12-lead ECGs were obtained at least 5 minutes apart within 1 hr before the start of infusion (pre-dose) on Day 1. Single ECGs were obtained at 0.5, 1, 1.5, 2, 3, 4, 6, and 12 hrs after the start of infusion on Day 1 and Day 15, within 1 hr before the start of the morning infusion on Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, and in the morning on Day 16. All the 12-lead ECGs were measured using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals.|Up to Day 16|Safety population|||Participants|||Number
2554862|NCT02751424|Primary|Part 1: Number of Participants With Electrocardiogram (ECG) Parameters of Potential Clinical Importance (PCI)|Triplicate 12-lead ECGs were obtained at least 5 minutes apart within 1 hr before dosing. Single ECGs were obtained at all other time points on Day 1 at 0.5 hr, 1 hr, 1.5 hr, 2, 3, 4, 6, 12 and 24 hr, Day 2 (36 hr) and Day 3 (48 hr) during Part 1 (single dose escalation phase) of the study. All the 12-lead ECGs were measured using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals.|Up to Day 3|Safety population|||Participants|||Number
2554863|NCT02751424|Primary|Part 2: Number of Participants Having Abnormal Urine Parameters (Using Dipstick Test) as a Measure of Safety|An aliquot of the urine samples from first morning void urine samples was collected to analyze specific gravity, pH, glucose, protein, blood and ketone bodies by dipstick method, microscopic examination (if blood or protein is abnormal), ACR, NGAL and KIM-1. These urine samples were analyzed after the end of the study to verify if a clinical signal is detected. The samples were collected on Day 2, 5, 10, and Day 15 of Part 2 (Repeat dose escalation) of the study.|Day 2, 5, 10 and Day 15|Safety population|||Participants|||Number
2554864|NCT02751424|Primary|Part 1: Number of Participants Having Abnormal Urine Parameters (Using Dipstick Test) as a Measure of Safety|An aliquot of the urine samples from first morning void urine samples was collected to analyze specific gravity, pH, glucose, protein, blood and ketone bodies by dipstick method, microscopic examination (if blood or protein is abnormal), albumin to creatinine ration (ACR), neutrophil gelatinase associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1). Urine samples were analyzed after the end of the study to verify if a clinical signal is detected. Urine samples were collected on Day 1 of Part 1 (Single-dose escalation) of the study.|Up to Day 2|Safety population.|||Participants|||Number
2554865|NCT02751424|Primary|Part 2: Number of Participants With Abnormal Clinical Chemistry Parameters as a Measure of Safety-Grade 3 or Higher|Blood samples were collected and processed to measure the number of participants with abnormal BUN, creat, glucose, bicarbonate, sodium, potassium, chloride, calcium, AST/SGOT, ALT/SGPT, ALP levels, uric acid, total and direct bilirubin, total protein and albumin. These were collected on Day 2, 5, 10 and Day 15 during Part 2 (repeat dose escalation), of the study. Participants with abnormalities Grade 3 or higher were reported.|Up to Day 15|Safety population|||Participants|||Number
2554866|NCT02751424|Primary|Part 1: Number of Participants With Abnormal Clinical Chemistry Parameters as a Measure of Safety-Grade 3 or Higher|Blood samples were collected and processed to measure the number of participants with abnormal blood urea nitrogen (BUN), creatinine, glucose, bicarbonate, sodium, potassium, chloride, calcium, aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), alkaline phosphatase (ALP) levels, uric acid, total and direct bilirubin, total protein and albumin. These were collected on Day 1, during Part 1(single dose escalation) of the study. Participants with abnormalities Grade 3 or higher were reported.|Day 2|Safety population|||Participants|||Number
2555018|NCT02750267|Secondary|Percent of Time Sensor Glucose Readings Are >150 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
2554867|NCT02751424|Primary|Part 2: Number of Participants With Abnormal Hematology Parameters as a Measure of Safety-Grade 3 or Higher|Blood samples were collected and processed to measure the number of participants with abnormal platelet counts, RBC count, WBC count (absolute), hemoglobin, hematocrit, reticulocytes, total iron, TIBC, ferritin, RBC indices MCV, MCH and MCHC and differential WBC count (neutrophils, lymphocytes, monocytes, eosinophils, and basophils). These were collected on Day 2, 5, 10 and Day 15, during Part 2 of the study. Part 2 is repeat dose escalation. Participants with abnormalities of Grade 3 or higher have been reported.|Up to Day 15|Safety population.|||Participants|||Number
2554868|NCT02751424|Primary|Part 1: Number of Participants With Abnormal Hematology Parameters as a Measure of Safety-Grade 3 or Higher|Blood samples were collected and processed to measure the number of participants with abnormal platelet counts, red blood cells (RBC) count, white blood cells (WBC) count (absolute), hemoglobin, hematocrit, reticulocytes, total iron, total iron binding capacity (TIBC), ferritin, RBC indices (mean corpuscle volume [MCV], mean corpuscle hemoglobin [MCH] and mean corpuscle hemoglobin concentration [MCHC]) and differential WBC count (neutrophils, lymphocytes, monocytes, eosinophil's, and basophils). Participants with abnormalities of Grade 3 or higher have been reported.|Up to Day 2|Safety population|||Participants|||Number
2554869|NCT02751424|Primary|Part 2: Number of Participants With AE and SAE|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, Is a congenital anomaly/birth defect, medical judgement and is associated with liver injury or liver impartment. The number of participants with AEs and SAEs assessed in Part 2 (Repeat dose) of the study were reported.|Up to Day 56|Safety population.|||Participants|||Number
2554870|NCT02751424|Primary|Part 1: Number of Participants With Adverse Event (AE) and Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, Is a congenital anomaly/birth defect, medical judgement and is associated with liver injury or liver impartment. The number of participants with AEs and SAEs assessed in Part 1 (Single dose) of the study were reported.|Up to Day 43|Safety population comprised of all participants who received at least 1 dose of study drug and had at least one post-dose safety assessment.|||Participants|||Number
2554871|NCT02751385|Secondary|Area Under the Concentration-time Curve of the Ethinylestradiol and Levonorgestrel in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity).|"Area under curve from zero to infinity (AUC0-∞) for ethinylestradiol and for levonorgestrel after intake of a single dose of the combination of ethinylestradiol and levonorgestrel. In Period 1, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h and 72h after drug administration of Microgynon®. Nintedanib in Period 2 was started at least 7 days before Microgynon® administration.~In Period 2, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 11.55h, 23.55h, 47.55h and 71.55h after drug administration of Microgynon®."|Please refer to description section for the details about the actual sampling time points|Pharmacokinetic Set (PKS): This analysis set includes all patients in the TS who contributes only one PK parameter value for one period to the statistical assessment.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2554872|NCT02751385|Primary|Maximum Measured Concentration (Cmax) of Ethinylestradiol and Levonorgestrel|"Maximum blood concentrations (Cmax) for ethinylestradiol and levonorgestrel after a single dose of the combination of ethinylestradiol and levonorgestrel. In Period 1, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h and 72h after drug administration of Microgynon®. Nintedanib in Period 2 was started at least 7 days before Microgynon® administration.~In Period 2, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 11.55h, 23.55h, 47.55h and 71.55h after drug administration of Microgynon®."|Please refer to description section for the details about the actual sampling time points|Pharmacokinetic Set (PKS): This analysis set includes all patients in the TS who contributes only one PK parameter value for one period to the statistical assessment.|||picogram/milliliter[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
2554873|NCT02751385|Primary|Area Under the Concentration-time Curve of the the Ethinylestradiol and Levonorgestrel in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC 0-tz) for ethinylestradiol and levonorgestrel after a single dose of the combination of ethinylestradiol and levonorgestrel. In Period 1, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 48h and 72h after drug administration of Microgynon®. Nintedanib in Period 2 was started at least 7 days before Microgynon® administration.~In Period 2, blood samples were collected at pre-dose at 0.35 hour (h) and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 11.55h, 23.55h, 47.55h and 71.55h after drug administration of Microgynon®."|Please refer to description section for the details about the actual sampling time points|Pharmacokinetic Set (PKS): This analysis set includes all patients in the Treated Set (TS) who contributes only one PK parameter value for one period to the statistical assessment.|||picogram*hour/mililiter||Geometric Coefficient of Variation|Geometric Mean
2554874|NCT02751320|Secondary|Enamel Fluoride Uptake (EFU) of All Study Formulation Variables|The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 μm through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as μg/cm^2.|At Week 4|ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product1-[1], Test product2-[2], Test product3-[3], Reference Product1-[1], Reference Product2-[1] and Reference Product3-[1].|||μg/cm^2||Standard Deviation|Mean
2554875|NCT02751320|Secondary|Enamel Fluoride Uptake (EFU) of All Study Formulation Variables|The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 μm through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as μg/cm^2.|At Week 2|ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product1-[1], Test product2-[1], Test product3-[2], Reference Product1-[1], Reference Product2-[1] and Reference Product3-[1].|||μg/cm^2||Standard Deviation|Mean
2554876|NCT02751320|Secondary|TMR Δm Value of 0.85% Phytate Compared to 0% Phytate, in the Presence of 1150ppm F and 0.3% ZnCl2, 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm F and 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm F and 0.85% Phytate|TMR was used to assess changes in the mineral status of partially demineralized enamel specimens. Lesions were analyzed at baseline and Integrated Mineral Loss (∆Z): (∆Z =(lesion depth x 87) - area under the curve [Area under the curve which relates volume % mineral at distances from the specimen surface with respect to section thickness]). After treatment a further section was taken from each lesion specimen for radiography assessment; ∆Z was calculated. The change which occurred in mineral content (∆M) of the lesions as a result of treatment was calculated by: ∆M= (baseline ∆Z - Post-treatment ∆Z).|Baseline upto 4 weeks|ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 2 - [1], Test product 3 - [2], Reference Product 2 - [1] and Reference Product 3 [1].|||[%vol mineral x µm||Standard Deviation|Mean
2554877|NCT02751320|Secondary|Transverse Microradiography (TMR) Net Remineralization Change (ΔM) Value of Phytate (0% 0.452% and 0.85%) at 4 Weeks|TMR was used to assess changes in the mineral status of partially demineralized enamel specimens. Lesions were analyzed at baseline and Integrated Mineral Loss (∆Z): (∆Z =(lesion depth x 87) - area under the curve [Area under the curve which relates volume % mineral at distances from the specimen surface with respect to section thickness]). After treatment a further section was taken from each lesion specimen for radiography assessment; ∆Z was calculated. The change which occurred in mineral content (∆M) of the lesions as a result of treatment was calculated by: ∆M= (baseline ∆Z - Post-treatment ∆Z).|Baseline upto 4 weeks|ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 1- [1], Test product 2- [1], and Reference Product 2- [1].|||[%vol mineral x µm||Standard Deviation|Mean
2554878|NCT02751320|Secondary|% SMHR of 0.85% Phytate Compared to 0% Phytate, in Presence of 1150ppm Fluoride and 0.3% ZnCl2, 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm Fluoride and 0.3% ZnCl2 Compared to 0% ZnCl2 in the Presence of 1150ppm Fluoride and 0.85% Phytate|SMHR test was used to assess the changes in mineralization status of partially demineralized enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. % SMHR was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization(D), indentation length (μm) after intra-oral exposure (R): [D-R/D-B]*100.|Baseline upto 2 weeks|ITT population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 2- [1], Test product 3- [2], Reference Product 2- [1], and Reference Product 3- [1].|||% SMHR||Standard Deviation|Mean
2554879|NCT02751320|Primary|Percentage Surface Microhardness Recovery (SMHR) of Phyte (0% 0.425% and 0.85%) at 2 Weeks|SMHR test was used to assess the changes in mineralization status of partially demineralized enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. % SMHR was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization(D), indentation length (μm) after intra-oral exposure (R): [D-R/D-B]*100.|Baseline upto 2 weeks|Intent-to-treat (ITT) population, all participants who were randomized, received the study products at least once and provided at least one post-baseline assessment of efficacy. Number of participants who missed enamel specimens were: Test product 1- [1], Test product 2- [1], Reference Product 1- [1], and Reference Product 2- [1].|||% SMHR||Standard Deviation|Mean
2554880|NCT02750943|Secondary|Number of Participants With Visible Blood in Expectorate (Presence [Trace, Substantial]/Absence) at Week4 and Week 12|Visible blood in expectorate for each participant was classified as (i) Present (Trace or Substantial) (ii) Absent. The number of participants with blood 'Present' (Trace or Substantial) or 'absent' in expectorate was analyzed.|Week 4, Week 12|Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at specific time points for respective treatment arm.|||number of participants|||Number
2554881|NCT02750943|Secondary|Modified Gingival Index (MGI) at Week 4 and Week 12|MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration.|Week 4, Week 12|Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at specific time points for respective treatment arm.|||score on a scale||Standard Error|Least Squares Mean
2554882|NCT02750943|Secondary|Bleeding Index (BI) at Week 4 and Week 12|BI was assessed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|Week 4, Week 12|Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at specific time points for respective treatment arm.|||score on a scale||Standard Error|Least Squares Mean
2554883|NCT02750943|Secondary|Number of Bleeding Sites at Week 4|Number of bleeding sites was measured as BI via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2.|Week 4|Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at Week 4 for respective treatment arm.|||number of bleeding sites||Standard Error|Least Squares Mean
2554884|NCT02750943|Primary|Number of Bleeding Sites at Week 12|Number of bleeding sites was measured as bleeding index (BI) via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth (7-7 in each arch). The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. Bleeding sites were assessed as the number of bleeding sites with a BI score of 1 or 2.|Week 12|Intent to treat (ITT) population which included all participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement. Number of participants analyzed is the number of participants from ITT population evaluated for this outcome at Week 12 for respective treatment arm.|||number of bleeding sites||Standard Error|Least Squares Mean
2554885|NCT02750930|Primary|Number of Participant With Positive Results of Anti-albiglutide Antibody Production Over Time|Anti-albiglutide antibodies were planned to be assessed using a validated enzyme-linked immunosorbent assay, which utilized a tiered testing approach. It was to be collected at specified timepoints at Week 0, Week 4, Week 10, Week 26 and Week 34 (follow-up). Confirmed positive samples were to be titrated to obtain the titer of anti-albiglutide antibodies. The number of participants with positive results of anti-albiglutide antibody production was to be reported. However, due to early termination only limited number of key safety data was analyzed. This study 204682 was planned as an extension of the main study, 200952 and was supposed to end well after the main study. However, the 204682 extension study was terminated prior to completion of the main study 200952, which is a double-blind study. To preserve the integrity of the main study 200952, results of anti-albiglutide antibody were not completed after the termination.|Up to Week 34|Safety population.||||||
2554886|NCT02750930|Primary|Number of Participants With Clinically Significant Findings for 12-lead ECG|A single 12-lead ECG was performed at the specified timepoints (Weeks 0, 26 and 34) during the study where the participant was instructed to be in semi-recumbent position for 10 to 15 minutes before obtaining the ECG. An ECG machine that automatically calculated the heart rate and measures like the PR, QRS, QT, and corrected QT intervals. Number of participants with clinically significant findings in ECG results has been reported.|Up to Week 34|Safety population.|||Participants|||Number
2554887|NCT02750930|Primary|Number of Participants With Systolic and Diastolic Blood Pressure of PCI|The systolic and diastolic blood pressure, were measured after completion of the ECG sampling at specified timepoints (Week 0, 4, 10, 22, 26 and Week 34). The participants were asked to be either in semi-recumbent or sitting position. During blood withdraws the vitals were performed prior to blood collection. Number of participants with systolic and diastolic blood pressure values of PCI has been reported.|Up to Week 34|Safety population|||Participants|||Number
2554888|NCT02750930|Primary|Number of Participants With Pulse Rate Values of PCI|The pulse rate, was measured after completion of the electrocardiogram (ECG) sampling at specified timepoints (Week 0, 4, 10, 22, 26 and Week 34). The participants were asked to be either in semi-recumbent or sitting position. During blood withdraws the vitals were performed prior to blood collection. Number of participants with pulse rate values of PCI has been reported.|Up to Week 34|Safety population|||Participants|||Number
2554889|NCT02750930|Primary|Number of Participants With Clinically Significant Urinalysis Abnormalities by Dipstick Method|Urine samples were collected early morning from the participants at specified timepoints (Weeks 26 to 52). The following urinalysis parameters were measured: specific gravity, power of hydrogen (pH), glucose, protein, blood and ketones by dipstick; microscopic examination (if blood or protein was abnormal). Number of participants with no clinically significant abnormalities in urinalysis dipstick results were reported.|Up to 26 weeks|Safety Population|||Participants|||Number
2554890|NCT02750930|Primary|Number of Participants With Clinical Chemistry Parameters of PCI|The following clinical chemistry parameters were measured: blood urea nitrogen (BUN), creatinine, calcium, bicarbonate, potassium, sodium, chloride, uric acid, aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase, gamma glutamyl transferase (GGT), total and direct bilirubin, total protein, and albumin at the specified timepoints (Week 0, 4, 10, 22, 26 and Week 34). Number of participants with clinical chemistry paramaters with PCI values has been reported.|Up to Week 34|Safety population|||Participants|||Number
2554992|NCT02750345|Primary|Maximum Observed Plasma Concentration (Cmax)||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least two treatment periods (where one of which is the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical pk analysis for the study.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2554891|NCT02750930|Primary|Number of Participants With Hematology Values of Potential Clinical Importance (PCI)|Blood samples were collected from the participants to evaluate the hematology paramaters. The following hematology parameters were measured: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), white blood cell (WBC) count, neutrophils, lymphocytes, monocytes, eosinophils, and basophils, at the specified timepoints (Week 0, 4, 10, 22, 26 and Week 34). Number of participants with hematology paramaters with PCI values has been reported.|Up to Week 34|Safety Population.|||Participants|||Number
2554892|NCT02750930|Primary|Number of Participants With Physical Examination Abnormalities|A full physical examination was planned to be done, at a minimum, assessment of the skin (including injection site), head, eyes, ears, nose, throat, thyroid, respiratory system cardiovascular system, abdomen (liver and spleen), lymph nodes, central nervous system and extremities was planned. The evaluation of skin (including injection site), respiratory system, cardiovascular system, abdomen (liver, spleen), and central nervous system was planned; however, it was not performed due to early termination of the study.|Up to Week 34|Safety Population.||||||
2554893|NCT02750930|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product whether or not it is considered drug related. This would include any side effect, injury, toxicity, sensitivity reaction, abnormal or worsening of a laboratory value, concurrent illness or sudden death. Pre-existing conditions that worsen during a study will be reported as AEs. SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect, or is associated with liver injury or impaired liver function. Number of participants who reported any AE or SAE during this extension study or who had ongoing AE or SAE from study 200952 have been presented.|Up to Week 34|Safety Population comprised of all enrolled participants who received at least 1 dose of study medication.|||Participants|||Number
2554894|NCT02750813|Secondary|Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14|The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity.|Day 14, each product|Full Analysis Set. Number Analyzed is the number of eyes with non-missing responses, including only subjects from one site.|||unitless|Eyes|Standard Deviation|Mean
2554895|NCT02750813|Primary|Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14|"Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as centered or slight decentration is reported. Lenses from both eyes contributed to the percentage."|Day 14, each product|Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.|||percentage of lenses|Eyes||Number
2554896|NCT02750800|Secondary|Correlation Between the Length of AbbVie Care 2.0 Duration and Participant Outcomes|The effectiveness of the AbbVie Care 2.0 patient care support program (PSP) on participant outcomes was to be analyzed by applying mixed linear models on outcomes including PSP utilization (continuous vs terminated) as fixed variables. Baseline participant outcome values were also to be included in the model.|From Baseline (Month 0) to 12 months|Assessment of the effectiveness of the length of PSP exposure on participant outcomes was not possible because of the low number of participants in the non-PSP group.||||||
2554897|NCT02750800|Secondary|Correlation Between Disease Activity Scores and Disease-specific Quality of Life Scores|"To define possible correlations between disease activity scores and disease specific quality of life scores, correlation analyses were performed. Correlation between patient socio-demographics, patient type and indication was not completed because these were uninterpretable per protocol.~ASQoL= Ankylosing Spondylitis Quality of Life questionnaire~ASDAS(ESR) = Ankylosing Spondylitis Disease Activity Score; laboratory parameter is a measurement of erythrocyte sedimentation rate (mm/hour; ESR)~DAS28(ESR)= Disease Activity Score 28; laboratory parameter is a measurement of erythrocyte sedimentation rate (mm/hour; ESR)~SIBDQ= Short Quality of Life in Inflammatory Bowel Disease Questionnaire~CDAI= Clinical Disease Activity Index~DLQI= Dermatology Life Quality Index~PASI= Psoriasis Area and Severity Index~pMayo= Partial Mayo score (Mayo score without endoscopy)"|Baseline (Month 0) and 12 months|All participants in the Full Analysis Set with evaluable data|||correlation coefficient|||Number
2554898|NCT02750800|Secondary|Participants' Rating of the AbbVie Care 2.0 Program at 12 Months|"All participants enrolled in the study were enrolled in the AbbVie Care 2.0 patient support (PSP) program. Participants rated the PSP program as either Very good, good, less satisfying or I do not use the services at the last study visit."|12 months|All participants in the Full Analysis Set with evaluable data|||Participants|||Count of Participants
2554899|NCT02750800|Secondary|Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 12 Months|The Psoriasis Area and Severity Index (PASI) is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Negative values indicate improvement from baseline.|Baseline (Month 0) and 12 months|All participants in the Full Analysis Set with psoriasis and evaluable data|||units on a scale||Standard Deviation|Mean
2554900|NCT02750800|Secondary|Mean Change From Baseline in Partial Mayo (pMayo) Score at 12 Months|The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). Negative values indicate improvement from baseline.|Baseline (Month 0) and 12 months|All participants in the Full Analysis Set with ulcerative colitis and evaluable data|||units on a scale||Standard Deviation|Mean
2554901|NCT02750800|Secondary|Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Score at 12 Months|The Crohn's Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn's disease. Participants were asked to record the frequency of stools, abdominal pain and general well-being on a daily basis. In addition to the diary data, the investigator assessed the following for the calculation of CDAI: presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. The CDAI is the sum of the products of each item multiplied by a weighting factor and generally ranges from 0 up to 600, where remission of Crohn's disease is defined as CDAI < 150, and severe disease is defined as CDAI > 450. Negative values indicate improvement from baseline.|Baseline (Month 0) and 12 months|All participants in the Full Analysis Set with Crohn’s disease and evaluable data|||units on a scale||Standard Deviation|Mean
2554902|NCT02750800|Secondary|Mean Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS ESR) at 12 Months|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of erythrocyte sedimentation rate (mm/hour; ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and ESR) are combined to yield a score (0 to no defined upper limit). Negative values indicate improvement from baseline.|Baseline (Month 0) and 12 months|All participants in the Full Analysis Set with either ankylosing spondylitis or psoriatic arthritis with axial symptoms and evaluable data|||units on a scale||Standard Deviation|Mean
2554903|NCT02750800|Secondary|Mean Change From Baseline in Disease Activity Score 28 (DAS28) at 12 Months|The Disease Activity Score 28 (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. Negative values indicate improvement from baseline.|Baseline (Month 0) and 12 months|All participants in the Full Analysis Set with either psoriatic arthritis with peripheral symptoms or rheumatoid arthritis and evaluable data|||units on a scale||Standard Deviation|Mean
2554904|NCT02750800|Secondary|Mean Change From the 12 Months Prior to Treatment With Adalimumab to the 12 Months After Beginning Treatment With Adalimumab in Health Resource Utilization: Number of Outpatient Visits|The number of outpatient visits to general practitioners, immune-mediated inflammatory disease specialists, ophthalmologists, gastroenterologists, dermatologists, rheumatologists, physiatrists, physiotherapists, and nurses over the 3 months preceding the first adalimumab administration was documented and multiplied by 4 to obtain an estimate of 12-month data. The 12-month total outpatient visits were obtained by adding the values obtained at months 3, 6, 9, and 12. Negative numbers indicate improvement from the prior 12 months.|12 months prior to treatment start (Month 0 [baseline]) and 12 months after treatment start (total 24 months)|All participants in the Full Analysis Set with evaluable data. Data were not collected for visits to physiatrists and physiotherapists in the Psoriasis Arm/Group, and for visits to physiatrists in the Rheumatoid Arthritis Arm/Group.|||occurrences||Standard Deviation|Mean
2554905|NCT02750800|Secondary|Mean Change From the 12 Months Prior to Treatment With Adalimumab to the 12 Months After Beginning Treatment With Adalimumab in Health Resource Utilization: Number of Hospitalizations and Number of Sick Leaves|The number of hospitalizations over the 3 months preceding the first adalimumab administration was documented and multiplied by 4 to obtain an estimate of 12-month data. The 12-month total hospitalizations were obtained by adding the values obtained at months 3, 6, 9, and 12. The number of sick leaves (in employed participants) over the 3 months preceding the first adalimumab administration was documented and multiplied by 4 to obtain an estimate of 12-month data. The 12-month total sick leaves were obtained by adding the values obtained at months 3, 6, 9, and 12. Negative numbers indicate improvement from the prior 12 months.|12 months prior to treatment start (Month 0 [baseline]) and 12 months after treatment start (total 24 months)|All participants in the Full Analysis Set with evaluable data; participants who were employed with available data at baseline and 12 months are included|||occurrences||Standard Deviation|Mean
2554906|NCT02750800|Secondary|Mean Change From the 12 Months Prior to Treatment With Adalimumab to the 12 Months After Beginning Treatment With Adalimumab in Health Resource Utilization: Number of Hospital Inpatient Days and Number of Sick Leave Days|The number of hospital inpatient days over the 3 months preceding the first adalimumab administration was documented and multiplied by 4 to obtain an estimate of 12-month data. The 12-month total post-treatment hospital inpatient days was obtained by adding the values obtained at months 3, 6, 9, and 12. The number of sick leave days (in employed participants) over the 3 months preceding the first adalimumab administration was documented and multiplied by 4 to obtain an estimate of 12-month data. The 12-month total post-treatment sick leave days was obtained by adding the values obtained at months 3, 6, 9, and 12. Negative numbers indicate improvement from the prior 12 months.|12 months prior to treatment start (Month 0 [baseline]) and 12 months after treatment start (total 24 months)|All participants in the Full Analysis Set with evaluable data; participants who were employed with available data at baseline and 12 months are included|||days||Standard Deviation|Mean
2554915|NCT02750800|Secondary|Mean Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score at 12 Months|The EQ-5D-5L measures quality of life in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on five levels of severity (1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems), and a separate visual analog scale (VAS). Responses to the five dimension scores were combined and converted into a single preference-weighted health utility index score. The range for the EQ-5D-5L index score is 0 to 1 with '0' defined as a health state equivalent to being dead and '1' is full health. The higher the score the better the health status. Positive numbers indicate improvement from baseline.|Baseline (Month 0) and 12 months|All participants in the Full Analysis Set with evaluable data|||units on a scale||Standard Deviation|Mean
2554907|NCT02750800|Secondary|Mean Change From Baseline in in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Score at 12 Months|The WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. Presenteeism indicates the percentage of impairment while working due to health problems. Absenteeism indicates the percentage of work time missed due to health problems. Total activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems. Total work productivity impairment (TWPI) indicates the percentage of overall work impairment due to health problems. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.|Baseline (Month 0) and 12 months|All participants in the Full Analysis Set with evaluable data; participants who were employed with available data at baseline and 12 months are included|||units on a scale||Standard Deviation|Mean
2554908|NCT02750800|Secondary|Mean Change From Baseline in Total Morisky Medication Adherence Scale, 4 Questions (MMAS-4) Score at 12 Months|The Morisky Medication Adherence Scale-4 (MMAS-4 ) is a 4-item self-reported measure of medication-taking behavior. It measures intentional and non-intentional non-adherence. The MMAS-4 score is the sum of four questions and ranges from 0 to 4: The coding is 0, 1 (low adherence), 2, 3 (moderate adherence) and 4 (high adherence). Positive numbers indicate improvement from baseline.|Baseline (Month 0) and 12 months|All participants in the Full Analysis Set with evaluable data|||units on a scale||Standard Deviation|Mean
2554909|NCT02750800|Secondary|Mean Change From Baseline in Total Satisfaction With Information About Medicines Scale (SIMS) Score at 12 Months|"The Satisfaction with Information about Medicines Scale (SIMS) assesses whether an individual has received enough information about a range of topics relating to prescribed medication. Participants are asked to rate the amount of information they have received using the following response scale: too much, about right, too little, none received, none needed. Total satisfaction rating is obtained by summing the scores for each item. If the participant is satisfied that he/she has received a particular aspect of medication information (with a rating of about right or none needed), this is given a score of 1. If the participant is dissatisfied with the amount of information received (with a rating of too much, too little, or none received), this is scored 0. Total scores range from 0 to 17 with high scores indicating a high degree of overall satisfaction with the amount of medication information received. Positive numbers indicate improvement from baseline."|Baseline (Month 0) and 12 months|All participants in the Full Analysis Set with evaluable data|||units on a scale||Standard Deviation|Mean
2554910|NCT02750800|Secondary|Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medicine (TSQM) Version 1.4 Score at 12 Months|The 14-item Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 is an instrument to show that adherence is expected to be related with participants' satisfaction with therapy and that such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction). Positive numbers indicate improvement from baseline.|Baseline (Month 0) and 12 months|All participants in the Full Analysis Set with evaluable data|||units on a scale||Standard Deviation|Mean
2554911|NCT02750800|Secondary|Mean Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at 12 Months in Participants With Ankylosing Spondylitis and Participants With Psoriatic Arthritis With Axial Symptoms|The Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire is a disease-specific instrument designed to measure health related quality of life (HRQOL) in participants with AS. Participants answer yes/no to 18 items assessing the current impact of AS on their quality of life status. The total score ranges from 0 to 18, with lower scores representing better AS-specific quality of life. Negative numbers indicate improvement from baseline.|Baseline (Month 0) and 12 months|All participants in the Full Analysis Set with either ankylosing spondylitis and or psoriatic arthritis with axial symptoms and evaluable data|||units on a scale||Standard Deviation|Mean
2554912|NCT02750800|Secondary|Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at 12 Months in Participants With Psoriasis and Psoriatic Arthritis|The Dermatology Life Quality Index (DLQI) is a self-reported questionnaire for capturing psychosocial effects of chronic skin disease on different areas of life within the previous seven days. The ten questions cover six areas: symptoms/feelings, daily activities, leisure, work/school, personal relationship, effects of treatment on daily life. Total DLQI scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst. Negative numbers indicate improvement from baseline.|Baseline (Month 0) and 12 months|All participants in the Full Analysis Set with either psoriasis or psoriatic arthritis and evaluable data|||units on a scale||Standard Deviation|Mean
2554913|NCT02750800|Secondary|Mean Change From Baseline in Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) Score at 12 Months in Participants With Crohn's Disease and Ulcerative Colitis|The SIBDQ is a disease-specific health-related quality of life (HRQOL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions; each question is scored on a scale from 1 (poor QOL) to 7 (optimum QOL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL). Positive numbers indicate improvement from baseline.|Baseline (Month 0) and 12 months|All participants in the Full Analysis Set with either Crohn’s disease or ulcerative colitis and evaluable data|||units on a scale||Standard Deviation|Mean
2554914|NCT02750800|Secondary|Mean Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale Score at 12 Months|"The EQ-5D-5L measures quality of life in five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on five levels of severity (1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems), and a separate visual analog scale (VAS). Participants rated their health on a vertical visual analogue scale, where the endpoints were labelled 100, The best health you can imagineand 0, The worst health you can imagine. Positive numbers indicate improvement from baseline."|Baseline (Month 0) and 12 months|All participants in the Full Analysis Set with evaluable data|||units on a scale||Standard Deviation|Mean
2554916|NCT02750800|Secondary|Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Mental Component Summary (MCS) Score at 12 Months|"The health assessment questionnaire Short Form 36 Version 2.0 (SF-36 V2 ) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst-100 best). Positive numbers indicate improvement from baseline."|Baseline (Month 0) and 12 months|All participants in the Full Analysis Set with evaluable data|||units on a scale||Standard Deviation|Mean
2554917|NCT02750800|Primary|Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at 12 Months|"The health assessment questionnaire Short Form 36 Version 2.0 (SF-36 V2 ) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst-100 best). Positive numbers indicate improvement from baseline."|Baseline (Month 0) and 12 months|All participants in the Full Analysis Set with evaluable data|||units on a scale||Standard Deviation|Mean
2554918|NCT02750761|Secondary|Palatability of Oral Tedizolid Phosphate Suspension in Participants Who Received Oral Tedizolid Phosphate|Palatability of oral tedizolid phosphate suspension in participants ages 6 to <12 years (Group 3) and 2 to <6 years (Group 4). Palatability was assessed using a 5-point hedonic scale and spontaneous verbal judgment. This hedonic scale consists of 5 pictures of line drawn faces corresponding to very bad, bad, neither good nor bad, good and very good. The participant was asked to mark or point to the face to show how they felt about the taste of the study drug. For preverbal children, the score was assessed by the parent/caregiver, or study staff administering or witnessing administration of the study drug.|Following single oral dose on Day 1|All participants who received an oral dose of tedizolid phosphate suspension.|||Participants|||Count of Participants
2554919|NCT02750761|Secondary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|1 day|All participants who received any study drug.|||Participants|||Count of Participants
2554920|NCT02750761|Secondary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 9 days|All participants who received any study drug.|||Participants|||Count of Participants
2554921|NCT02750761|Primary|Dose Normalized Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity|The area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to infinity following administration of IV or oral dose, normalized to dosage, was calculated. Per protocol, this outcome used pooled groups as follows: The IV Group pooled Groups 1 and 2, who received tedizolid phosphate via intravenous (IV) administration; the Oral Group pooled groups 3 and 4, who received tedizolid phosphate via oral administration. Pharmacokinetic sampling occurred at the following time points: Group 1 (part of the IV Group): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (part of the IV Group): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (part of the Oral Group): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (part of the Oral Group): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.|IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.|All participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid necessary to calculate the AUC. Per protocol, participant arms were pooled based on route of administration (IV or Oral) and outcome was normalized to the dose received.|||hr*ng/mL/mg/kg||95% Confidence Interval|Geometric Least Squares Mean
2554922|NCT02750761|Primary|Clearance (CL/F) of Tedizolid (Active Metabolite) in Participants Who Received Oral Tedizolid Phosphate|CL/F of tedizolid, in participants ages 6 to <12 years (Group 3) and 2 to <6 years (Groups 4).|Group 3 (6 to <12 years): at 1, 2, 3, 4, 6, 8, 12, and 24 hours after the dose; Group 4 (2 to <6 years): at 3, 6, 9, 12, 24 and 48 hours after the dose|All participants who received an oral dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid of tedizolid necessary to calculate the CL/F.|||mL/hr/kg||Geometric Coefficient of Variation|Geometric Mean
2554923|NCT02750761|Primary|Clearance (CL) of Tedizolid (Active Metabolite) in Participants Who Received Tedizolid Phosphate Intravenously (IV)|CL of IV tedizolid phosphate and its active metabolite, tedizolid, in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2).|Group 1 (6 to <12 years): Day 1 immediately after infusion and at 1.5, 2, 3, 4, 6, 12, and 24 hours. Group 2 (2 to <6 years): Day 1 immediately after infusion and at 3, 6, 12, 24 and 48 hours.|All participants who received an IV infusion of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid of tedizolid necessary to calculate the CL.|||mL/hr||Geometric Coefficient of Variation|Geometric Mean
2554939|NCT02750709|Secondary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2554924|NCT02750761|Primary|Terminal Elimination Half-life (T1/2) of Tedizolid (Active Metabolite)|Terminal elimination half-life (T1/2) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.|IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.|All participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid necessary to calculate the T1/2.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2554925|NCT02750761|Primary|Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Infinity|Area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to infinity following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.|IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.|All participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid necessary to calculate the AUC.|||hr*ng/mL||95% Confidence Interval|Geometric Least Squares Mean
2554926|NCT02750761|Primary|Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid (Active Metabolite) From Time Zero to Last Detectable Measurement|Area under the plasma concentration time curve (AUC) of tedizolid (active metabolite) from time zero to last detectable measurement following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.|IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.|All participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid necessary to calculate the AUC.|||hr*ng/mL||95% Confidence Interval|Geometric Least Squares Mean
2554927|NCT02750761|Primary|Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid (the Active Metabolite)|Time to reach peak plasma concentration (Tmax) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.|IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.|All participants who received a dose of tedizolid phosphate and had at least one quantifiable (above the lower limit of quantification) post-administration concentration of tedizolid.|||Hours||Full Range|Median
2554928|NCT02750761|Primary|Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid (the Active Metabolite)|Maximum observed drug concentration in plasma (Cmax) of tedizolid (active metabolite) following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.|IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.|All participants who received a dose of tedizolid phosphate and had at least one quantifiable (above the lower limit of quantification) post-administration concentration of tedizolid.|||ng/mL||95% Confidence Interval|Geometric Least Squares Mean
2554929|NCT02750761|Primary|Clearance (CL/F) of Tedizolid Phosphate in Participants Who Received Oral Tedizolid Phosphate (Prodrug)|CL/F of oral suspension tedizolid phosphate and its active metabolite, tedizolid, in participants ages 6 to <12 years (Group 3) and 2 to <6 years (Groups 4).|Group 3 (6 to <12 years): at 1, 2, 3, 4, 6, 8, 12, and 24 hours after the dose; Group 4 (2 to <6 years): at 3, 6, 9, 12, 24 and 48 hours after the dose|All participants who received an oral dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the CL/F. All orally dosed participants' data were below the lower limit of quantification, resulting in no reportable data.|||mL/hr/kg||Geometric Coefficient of Variation|Geometric Mean
2554930|NCT02750761|Primary|Clearance (CL) of Tedizolid Phosphate (Prodrug) in Participants Who Received Tedizolid Phosphate Intravenously (IV)|CL of IV tedizolid phosphate in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2).|Group 1 (6 to <12 years): Day 1 immediately after infusion and at 1.5, 2, 3, 4, 6, 12, and 24 hours. Group 2 (2 to <6 years): Day 1 immediately after infusion and at 3, 6, 12, 24 and 48 hours.|All participants who received an IV infusion of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the CL. Only 1 participant, from Group 2 Cohort 2, had analyzable data for this outcome measure.|||mL/hr||Geometric Coefficient of Variation|Geometric Mean
2554972|NCT02750501|Other Pre-specified|GI Symptoms|GI symptoms recorded in GI diaries by subject and/or caregiver.|Observation, Baseline and RELiZORB Treatment periods (Day -14 to Day 90): 104 days with additional 30 days of follow up.|All subjects who entered the RELiZORB Treatment Period and received at least one treatment with RELiZORB.|||Participants|||Count of Participants
2554931|NCT02750761|Primary|Terminal Elimination Half-life (T1/2) of Tedizolid Phosphate (Prodrug)|Terminal elimination half-life (T1/2) of tedizolid phosphate following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.|IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.|All participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the T1/2. Only 1 participant, from Group 2 Cohort 2, had analyzable data for this outcome measure.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2554932|NCT02750761|Primary|Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Infinity|Area under the plasma concentration time curve (AUC) of tedizolid phosphate from time zero to infinity following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.|IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.|All participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the AUC. Only 1 participant, from Group 2 Cohort 2, had analyzable data for this outcome measure.|||hr*ng/mL||Full Range|Median
2554933|NCT02750761|Primary|Area Under the Plasma Concentration Time Curve (AUC) of Tedizolid Phosphate (Prodrug) From Time Zero to Last Detectable Measurement|Area under the plasma concentration time curve (AUC) of tedizolid phosphate from time zero to last detectable measurement following administration of IV or oral dose. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.|IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.|All participants who received a dose of tedizolid phosphate and had adequate quantifiable (above the lower limit of quantification) post-administration concentrations of tedizolid phosphate necessary to calculate the AUC.|||hr*ng/mL||95% Confidence Interval|Geometric Least Squares Mean
2554934|NCT02750761|Primary|Time to Reach Peak Plasma Concentration (Tmax) of Tedizolid Phosphate (Prodrug)|Time to reach peak plasma concentration (Tmax) of tedizolid phosphate in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2). Tedizolid phosphate concentrations were below the lower limit of quantification in Group 3 and Group 4. Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.|IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.|All participants who received a dose of tedizolid phosphate and had at least one quantifiable (above the lower limit of quantification) post-administration concentration of tedizolid phosphate.|||Hours||Full Range|Median
2554935|NCT02750761|Primary|Maximum Observed Drug Concentration in Plasma (Cmax) of Tedizolid Phosphate (Prodrug)|Cmax of tedizolid phosphate in participants ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2). Pharmacokinetic sampling occurred at the following time points: Group 1 (6 to <12 years): Day 1 immediately after infusion and 1.5, 2, 3, 4, 6, 12, and 24 hours; Group 2 (IV): Day 1 immediately after infusion and 3, 6, 12, 24 and 48 hours; Group 3 (6 to <12 years): Day 1 at 1, 2, 3, 4, 6, 8, 12, and 24 hours after oral dose; Group 4 (2 to <6 years): Day 1 at 3, 6, 9, 12, 24 and 48 hours after oral dose.|IV: immediately after the end of the infusion, and various time points up to 48 hours after the start of infusion as described above. Oral: at various time points up to 48 hours after the dose as described above.|All participants who received a dose of tedizolid phosphate and had at least one quantifiable (above the lower limit of quantification) post-administration concentration of tedizolid phosphate.|||ng/mL||95% Confidence Interval|Geometric Least Squares Mean
2554936|NCT02750709|Secondary|Apparent Terminal Half-life (t1/2)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr||Geometric Coefficient of Variation|Geometric Mean
2554937|NCT02750709|Secondary|Terminal Elimination Rate Constant (λz)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||1/hr||Geometric Coefficient of Variation|Geometric Mean
2554938|NCT02750709|Secondary|Time to Maximum Observed Plasma Concentration (Tmax)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr||Full Range|Median
2554940|NCT02750709|Secondary|Area Under the Plasma Concentration Versus Time Curve, From Time Zero to 72 Hours Post-dose (AUC(0-72))||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2554941|NCT02750709|Primary|Area Under the Plasma Concentration Versus Time Curve, From Time Zero to 120 Hours Post-dose (AUC(0-120))||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2554942|NCT02750709|Primary|Maximum Observed Plasma Concentration (Cmax)||0, 0.25, 0.50, 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2554943|NCT02750618|Secondary|Percent Change From Baseline Over Time in Serum ALP||Baseline, Weeks 4, 12, 20, 40, 48, 56, 64, 76, 88, 100, 112, 124, 136, 148, 160|PK/PD Analysis Set: all participants who received at least one dose of study drug and had evaluable blood samples at given time point.|||percent change||Standard Deviation|Mean
2554944|NCT02750618|Secondary|Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP)|The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with exchangeable covariance structure.|Baseline, Weeks 4, 12, 20, 40, 48, 56, 64, 76, 88, 100, 112, 124, 136, 148, 160|PK/PD Analysis Set: all participants who received at least one dose of study drug and had evaluable blood samples at given time point.|||U/L||Standard Error|Least Squares Mean
2554945|NCT02750618|Secondary|Change From Baseline Over Time in Recumbent Length/Standing Height as Assessed by Percentiles||Baseline, Weeks 12, 24, 40, 64, 88, 112, 136, 160|Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement at given time point.|||percentiles||Standard Deviation|Mean
2554946|NCT02750618|Secondary|Change From Baseline Over Time in Recumbent Length/Standing Height as Assessed by Height-for-Age Z-Scores|Recumbent length/Standing height z scores are measures of height adjusted for a child's age and sex. The Z-score indicates the number of standard deviations away from a reference population (from the CDC growth charts) in the same age range and with the same sex. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome.|Baseline, Weeks 12, 24, 40, 64, 88, 112, 136, 160|Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement at given time point.|||Z score||Standard Deviation|Mean
2554947|NCT02750618|Secondary|Change From Baseline Over Time in Recumbent Length/Standing Height||Baseline, Weeks 12, 24, 40, 64, 88, 112, 136, 160|Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement at given time point.|||cm||Standard Deviation|Mean
2554948|NCT02750618|Secondary|RGI-C Lower Limb Deformity Score at Week 64|Changes in the severity of lower extremity skeletal abnormalities were assessed centrally by three independent pediatric radiologists contracted by a central imaging facility using a disease specific qualitative RGI-C scoring system. The RGI-C is a seven point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets). The GEE model includes the RGI-C score as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure.|Week 64|Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement.|||units on a scale||Standard Error|Least Squares Mean
2554949|NCT02750618|Secondary|RGI-C Lower Limb Deformity Score at Week 40|Changes in the severity of lower extremity skeletal abnormalities were assessed centrally by three independent pediatric radiologists contracted by a central imaging facility using a disease specific qualitative RGI-C scoring system. The RGI-C is a seven point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets). The ANCOVA model includes the RGI-C score as the dependent variable, age and RSS at baseline as covariates.|Week 40|Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement.|||units on a scale||Standard Error|Least Squares Mean
2554950|NCT02750618|Secondary|Change From Baseline in Rickets at Week 64 as Assessed by the RSS Total Score|The RSS system is a 10-point radiographic scoring method that was developed to assess the severity of nutritional rickets in the wrists and knees based on the degree of metaphyseal fraying, cupping, and the proportion of the growth plate affected. Scores are assigned for the unilateral wrist and knee X-rays deemed by the rater to be the more severe of the bilateral images. The maximum total score on the RSS is 10 points, with a total possible score of 4 points for the wrists and 6 points for the knees. Higher scores indicate greater rickets severity. The GEE model includes the change from baseline in RSS as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure.|Baseline, Week 64|Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement.|||units on a scale||Standard Error|Least Squares Mean
2554973|NCT02750501|Secondary|Plasma Composition (%) Ratio of n6/n3 Fatty Acids.|Change over time in n6/n3 ratio in plasma in the ITT population|RELiZORB Treatment Period (Day 0-Day 90): 90 days||||percentage of total plasma concentration||95% Confidence Interval|Least Squares Mean
2554951|NCT02750618|Secondary|Change From Baseline in Rickets at Week 40 as Assessed by the RSS Total Score|The RSS system is a 10-point radiographic scoring method that was developed to assess the severity of nutritional rickets in the wrists and knees based on the degree of metaphyseal fraying, cupping, and the proportion of the growth plate affected. Scores are assigned for the unilateral wrist and knee X-rays deemed by the rater to be the more severe of the bilateral images. The maximum total score on the RSS is 10 points and the minimum score is 0, with a total possible score of 4 points for the wrists and 6 points for the knees. Higher scores indicate greater rickets severity.The ANCOVA model includes the RGI-C score as the dependent variable, age and RSS at baseline as covariates.|Baseline, Week 40|Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement.|||units on a scale||Standard Error|Least Squares Mean
2554952|NCT02750618|Secondary|RGI-C Score at Week 64|Changes in the severity of rickets and bowing were assessed centrally by three independent pediatric radiologists contracted by a central imaging facility using a disease specific qualitative RGI-C scoring system. The RGI-C is a seven point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets). The GEE model includes the RGI-C score as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure.|Week 64|Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement.|||units on a scale||Standard Error|Least Squares Mean
2554953|NCT02750618|Secondary|Radiographic Global Impression of Change (RGI-C) Score at Week 40|Changes in the severity of rickets and bowing were assessed centrally by three independent pediatric radiologists contracted by a central imaging facility using a disease specific qualitative RGI-C scoring system. The RGI-C is a seven point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets). The Analysis of Covariance (ANCOVA) model includes the RGI-C score as the dependent variable, age and RSS at baseline as covariates.|Week 40|Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement.|||units on a scale||Standard Error|Least Squares Mean
2554954|NCT02750618|Primary|Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation|An AE was defined as any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. A serious AE was defined as an AE that at any dose, in the view of either the Investigator or Sponsor, results in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or disability, a congenital anomaly/birth defect, or other important medical events (according to the investigator). An AE was considered a TEAE if it occurred on or after the first dose and was not present prior to the first dose, or it was present prior to the first dose but increased in severity during the study. Events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), grade 5 (death).|From first dose of study drug through the end of the study (Week 160). Maximum duration of exposure to study drug was 160 weeks.|Safety Analysis Set: all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2554955|NCT02750618|Primary|Change From Baseline at Week 40 in Serum Phosphorus|The Generalized Estimation Equation (GEE) model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with exchangeable covariance structure.|Baseline, Week 40|Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: all participants who received at least one dose of study drug and had evaluable blood samples.|||mg/dL||Standard Error|Least Squares Mean
2554956|NCT02750592|Secondary|Participants With Newly Occurring Notable Abnormalities in Vital Signs|"Sitting Pulse (bpm) High only (> 100 bpm) Low only (< 60 bpm) Low and High (< 60 bpm and > 100 bpm)~Sitting Diastolic Blood Pressure (BP) (mmHg) High only (≥ 90 mmHg) Low only (< 60 mmHg) Low and High (< 60 mmHg and ≥ 90 mmHg)~Sitting Systolic Blood Pressure (mmHg) High only (≥ 140 mmHg) Low only (< 90 mmHg) Low and High (< 90 mmHg and ≥ 140 mmHg)"|week 60|safety set|||participants|||Number
2554957|NCT02750592|Secondary|Number of Participants With Newly Occurring or Worsening Lipid Parameters Abnormalities|During the entire safety reporting period, mean values of each lipid parameter stayed within the normal range and were comparable to the baseline values|week 60|safety set|||participants|||Number
2554958|NCT02750592|Secondary|Participants With Newly Occurring or Worsening Liver Enzyme Abnormalities|"During the entire safety reporting period, mean values of each liver enzyme parameter stayed within the normal range and were comparable to the baseline values~ALP=Alkaline phosphatase ALT=Alanine aminotransferase AST=Aspartate aminotransferase TBL=Total bilirubin ULN=Upper Limit Normal"|week 60|safety set|||participants|||Number
2554959|NCT02750592|Secondary|Number of Participants With Newly Occurring or Worsening Chemistry Abnormalities Based on CTCAE Grade|"Common Terminology Criteria for Adverse Events (CTCAE) Grades 1-5 refer to severity of the AE:~Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.~Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL)*.~Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL**.~Grade 4 Life-threatening consequences; urgent intervention indicated.~Grade 5 Death related to AE.~*Instrumental ADL include preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.~**Self care ADL include bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden."|week 60|safety set|||participants|||Number
2554974|NCT02750501|Secondary|Erythrocyte Composition (%) Ratio of n6/n3 Fatty Acids|Change from baseline to Day 90 in n6/n3 ratio in erythrocytes|RELiZORB Treatment Period (Day 0-Day 90): 90 days||||percentage of RBC composition||95% Confidence Interval|Least Squares Mean
2554960|NCT02750592|Secondary|Number of Participants With Newly Occurring or Worsening Hematology Abnormalities Based on CTCAE Grade, Blood|"Common Terminology Criteria for Adverse Events (CTCAE) Grades 1-5 refer to severity of the AE:~Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.~Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL)*.~Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL**.~Grade 4 Life-threatening consequences; urgent intervention indicated.~Grade 5 Death related to AE.~*Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.~**Self care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden."|week 60|The safety set included all patients who took at least one dose of study treatment during the treatment periods.|||participants|||Number
2554961|NCT02750592|Secondary|Number of Participants With Immunogenicity Against Secukinumab|"Concentration of anti-secukinumab antibodies~Assessment of immunogenicity against secukinumab by concentration of anti-secukinumab antibodies at pre-dose.~An electrochemiluminescence method was used for the detection of potential anti-secukinumab antibody formation."|week 60|The safety set included all patients who took at least one dose of study treatment during the treatment periods.|||participants|||Number
2554962|NCT02750592|Secondary|Change in Serum Concentration of Secukinumab|"The assessment of pre dose concentration of secukinumab in Japanese AS patients~An enzyme-linked immunosorbent assay (ELISA) method will be used for bioanalytical analysis of secukinumab in serum, with an anticipated lower limit of quantification (LLOQ) of 80 ng/mL."|Baseline, weeks 4, 16, 24, 52, 60|FAS|||μg/mL||Standard Deviation|Mean
2554963|NCT02750592|Secondary|Proportion of Participants Achieving ASAS Partial Remission|"The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients achieving an ASAS partial remission~The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 10"|week 16|FAS|||participants|||Number
2554964|NCT02750592|Secondary|Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score|"The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL)~The ASQoL is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each yes response and no points for each no response resulting in overall scores that range from 0 (least severity) to 18 (highest severity)"|Baseline, week 16|FAS|||scores on a scale||Standard Deviation|Mean
2554965|NCT02750592|Secondary|Change From Baseline in Short Form Health Survey Physical Component Summary (SF-36 PCS) Score|"SF-36 PCS, mean change from baseline:~The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline in Short Form Health Survey Physical Component Summary (SF-36 PCS)~The SF-36 is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions~Score range is from 0 (no problems) to 100 (unable to perform the activity)~SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline. There is no total overall score; scoring is computed for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score."|Baseline, week 16|FAS|||scores on a scale||Standard Deviation|Mean
2554966|NCT02750592|Secondary|Mean Change From Baseline in BASDAI From Baseline|"The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline in total BASDAI~The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions asked of the patient pertaining to the five major symptoms of AS~Each question (question 1 to 6) is scored from 0 to 10 (0 being no problem and 10 being the worst problem). To give each symptom equal weighting, the mean (average) of the two scores relating to morning stiffness (questions 5 and 6) is taken. The mean of questions 5 and 6 is added to the scores from questions 1-4. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score."|Baseline, week 16|FAS|||scores on a scale||Standard Deviation|Mean
2554967|NCT02750592|Secondary|Number of Participants With ASAS 5/6 Response Criteria|"The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients meeting the ASAS 5/6 response criteria~The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains"|Week 16|FAS|||participants|||Number
2554968|NCT02750592|Secondary|Change in High Sensitivity C-Reactive Protein (hsCRP)|"hsCRP (mg/L) change from baseline using observed data with log e transformation~The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the change from baseline of high sensitivity C-Reactive Protein (hsCRP)~hsCRP is measured as a marker of inflammation from blood samples during the study"|baseline, Week 16|FAS|||mg/L||95% Confidence Interval|Geometric Mean
2554969|NCT02750592|Secondary|Bath Ankylosing Spondylitis Disease Activity (BASDAI) 50 Response Rate|"The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients achieving Bath Ankylosing Spondylitis Disease Activity (BASDAI) 50 response~The BASDAI 50 is defined as an improvement of at least 50% in the BASDAI compared to baseline"|Week 16|FAS|||participants|||Number
2554970|NCT02750592|Secondary|ASAS 40 Response Rate With Non-responder Imputation (NRI)|"The efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline based on the proportion of patients achieving an ASAS 40 response~ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain"|Week 16|FAS|||participants|||Number
2554971|NCT02750592|Primary|Assessment of SpondyloArthritis International Society 20 Response (ASAS20)|"This table is ASAS20 response using non-responder imputation for FAS~It assesses the efficacy of secukinumab 150 mg s.c. at Week 16 relative to baseline in Japanese patients with active AS based on the proportion of patients achieving an ASAS (Assessment of SpondyloArthritis International Society criteria) 20 response.~The ASAS Response Criteria (ASAS 20) is defined as an improvement of ≥ 20% and ≥ 1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥ 20% and ≥ 1 unit on a scale of 10 in the remaining domain"|week 16|Full analysis set (FAS): The FAS comprised of all patients who entered into the treatment periods.|||participants|||Number
2554978|NCT02750501|Secondary|Unanticipated Adverse Device Effects (UADE)|A UADE is analogous to a serious adverse event (SAE), defined as an AE, occurring at any exposure to the therapeutic agent, that results in any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolonged existing hospitalization, a persistent or significant disability or incapacity or a congenital anomaly/birth defect.|RELiZORB Treatment Period (Day 0-Day 90): 90 days with additional 30 days of follow up.|Total ITT population (n=39)|||participants|||Number
2554979|NCT02750501|Primary|Change From Baseline of Erythrocyte Omega-3 Index % (DHA+EPA)|Change from baseline Day 0 to Day 90 of erythrocyte tissue composition % of the omega-3 index|Day 0 to Day 90|Intent to treat population = 39 subjects who received at least one exposure to RELiZORB. Analysis group is 38 due to one subject discontinuing prior to Visit 3.|||percentage of omega-3 composition||Standard Error|Least Squares Mean
2554980|NCT02750410|Secondary|Change From Baseline in Daily Total Insulin Dose|Mean change from baseline in total insulin dose was measured in each treatment groups.|Baseline, Week 16|All randomized participants who received at least one dose of study drug.|||International Units (IU)/Day||Standard Deviation|Mean
2554981|NCT02750410|Secondary|Change From Baseline in Body Weight|LS mean change from baseline in body weight was calculated using a REML based MMRM and was adjusted by, baseline value, treatment, visit, treatment-by-visit, baseline HbA1c group (<8.5%, >=8.5%), insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.|Baseline, Week 16|All randomized participants who received at least one dose of study drug and had evaluable post baseline data.|||kilogram (kg)||Standard Error|Least Squares Mean
2554982|NCT02750410|Secondary|Change From Baseline in Plasma Glucose From 7-Point Self-Monitored Blood Glucose Profiles (SMBG)|The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: prebreakfast blood glucose (BG), breakfast 2-hour postprandial blood glucose (PPBG), prelunch BG, lunch 2-hour PPBG, predinner BG, dinner 2-hour PPBG, and bedtime BG. LS mean was calculated with fixed effect test of analysis of covariance (ANCOVA) model and adjusted by, baseline value, treatment, baseline HbA1c Group (<8.5%, ≥8.5%), insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin).|Baseline, Week 16|All randomized participants who received at least one dose of study drug and had evaluable post baseline data.|||mg/dL||Standard Error|Least Squares Mean
2554983|NCT02750410|Secondary|Change From Baseline in Fasting Serum Glucose (FSG)|The LS mean change from baseline in FSG was calculated using a REML based MMRM and adjusted by, baseline value, treatment, visit, treatment-by-visit, baseline HbA1c Group (<8.5%, >=8.5%) + insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.|Baseline, Week 16|All randomized participants who received at least one dose of study drug and had evaluable post baseline data.|||milligram/deciliter (mg/dL)||Standard Error|Least Squares Mean
2554984|NCT02750410|Secondary|Percentage of Participants With HbA1c <7.0% or ≤6.5%|Percentage of participants whose HbA1c was <7.0% or ≤6.5%. HbA1c <7.0% is presented.|Week 16|All randomized participants who received at least one dose of study drug had evaluable post-baseline HbA1c data. HbA1c ≤6.5% had no results since model did not converge.|||percentage of participants|||Number
2554985|NCT02750410|Primary|Change From Baseline in Hemoglobin A1c (HbA1c)|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline HbA1c, treatment, visit, and treatment-by-visit insulin regimen (basal insulin, premixed insulin, or basal/mealtime insulin), where participant treated as a random effect.|Baseline, Week 16|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c.|||percentage of HbA1c||Standard Error|Least Squares Mean
2554986|NCT02750345|Secondary|Apparent Terminal Elimination Half-life (t1/2)||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of which must be the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical pk analysis for the study.|||hr||Geometric Coefficient of Variation|Geometric Mean
2554987|NCT02750345|Secondary|Terminal Elimination Rate Constant (λz)||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of which must be the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical pk analysis for the study|||1/hr||Geometric Coefficient of Variation|Geometric Mean
2554988|NCT02750345|Secondary|Time to Maximum Observed Plasma Concentration (Tmax)||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of which must be the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical analysis for the study.|||hr||Full Range|Median
2554989|NCT02750345|Secondary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞))||0 - 120 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of which is the reference product), and who had no major protocol deviations thought to impact on the analysis of pk data were included in the statistical pk analysis for the study|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2554990|NCT02750345|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-72))||0 - 72 hours post-dose|All subjects for whom the primary pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods must be the reference product), and who had no major protocol deviations thought to impact on the analysis of the pk data were included in the statistical pk analysis for the study.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2554991|NCT02750345|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-120))||0 - 120 hours post-dose|All subjects for whom the primary Pk parameters Cmax and AUC (0-120) could be calculated for at least 2 treatment periods (where one of the treatment includes the reference product), and who had no major protocol deviations thought to impact the analysis of the pk data were included for the statistical pk analysis for the study.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2555075|NCT02748356|Primary|Lactobacillus Safety|Total Adverse Events (AE + Serious AE) per participants|months 1-18 of study||||Adverse Events||Standard Deviation|Mean
2554993|NCT02750332|Secondary|Apparent Terminal Elimination Half-life (t1/2)||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr||Geometric Coefficient of Variation|Geometric Mean
2554994|NCT02750332|Secondary|Terminal Elimination Rate Constant (λz)||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||1/hr||Geometric Coefficient of Variation|Geometric Mean
2554995|NCT02750332|Secondary|Time to Maximum Observed Plasma Concentration (Tmax)||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr||Full Range|Median
2554996|NCT02750332|Secondary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC(0-∞))||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2554997|NCT02750332|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-72))||0 - 72 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2554998|NCT02750332|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-120))||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2554999|NCT02750332|Primary|Maximum Observed Plasma Concentration (Cmax)||0 - 120 hours post-dose|All subjects for whom the primary PK parameters Cmax and AUC(0-120) could be calculated for at least 2 treatment periods (where one of the treatment periods is the Reference product), and who had no major protocol deviations thought to impact on the analysis of the PK data were included in the statistical PK analysis for the study.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2555000|NCT02750306|Secondary|Change From Baseline in Polysomnography-derived Wakefulness After Persistent Sleep Onset (WASO) at Week 4|WASO was measured at Baseline and at Week 4 in a sleep laboratory by polysomnography during an 8-hour recording period beginning at participants' habitual bedtime.|Baseline and Week 4|All randomized participants who received at least 1 dose of study medication, had a baseline value for change from baseline analyses, and at least 1 post-randomization observation for the analysis endpoint subsequent to at least 1 dose of study medication|||Minutes||95% Confidence Interval|Least Squares Mean
2555001|NCT02750306|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Up to 4 weeks|All randomized participants who received at least 1 dose of study medication|||Percentage of participants|||Number
2555002|NCT02750306|Primary|Percentage of Participants Who Experienced One or More Adverse Events|An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Up to 6 weeks|All randomized participants who received at least 1 dose of study medication|||Percentage of participants|||Number
2555003|NCT02750306|Primary|Change From Baseline in Polysomnography-derived Total Sleep Time (TST) at Week 4|TST was measured at Baseline and at Week 4 in a sleep laboratory by polysomnography, during an 8-hour recording period beginning at participants' habitual bedtime.|Baseline and Week 4|All randomized participants who received at least 1 dose of study medication, had a baseline value for change from baseline analyses, and at least 1 post-randomization observation for the analysis endpoint subsequent to at least 1 dose of study medication|||Minutes||95% Confidence Interval|Least Squares Mean
2555004|NCT02750267|Secondary|End of Night Blood Glucose|All subjects have blood glucose evaluated upon rising (approximately 7 am) and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
2555005|NCT02750267|Secondary|Incidence of Hypoglycemia Per Subject, Defined by Handheld Meter Glucose <70 mg/dL|All subjects have hypoglycemia monitored by meter analysis and compared between time on closed-loop system and time on usual care period.|68 hours||||events per subject, glucometer <70mg/dL||Standard Deviation|Mean
2555006|NCT02750267|Secondary|Hyperglycemia Area Under the Curve >250 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
2555007|NCT02750267|Secondary|Hyperglycemia Area Under the Curve >180|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
2555008|NCT02750267|Secondary|Hypoglycemia Area Under the Curve <70 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
2555009|NCT02750267|Secondary|Hypoglycemia Area Under the Curve <60|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|72 hours|||||||
2555019|NCT02750267|Secondary|Percent of Time Sensor Glucose Readings Are <70 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|68 hours||||percentage of time below 70 mg/dL||Standard Deviation|Mean
2555020|NCT02750267|Primary|Percent of Sensor Glucose Readings Between 70-180 mg/dL|All subjects have CGM output analyzed and compared between time on closed-loop system and time on usual care period.|68 hours||||percentage of time in range||Standard Deviation|Mean
2555021|NCT02749903|Secondary|Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0|The number of patients experiencing at least one grade 3+ adverse event using CTCAE version 4.0 is summarized below.|30 days post-treatment, up to 32 months||||Participants|||Count of Participants
2555022|NCT02749903|Secondary|Progression-free Survival|Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 32 months post study enrollment||||months||95% Confidence Interval|Median
2555023|NCT02749903|Primary|Best Overall Response Rate|The best overall response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.|Up to 32 weeks||||percentage of patients||95% Confidence Interval|Number
2555024|NCT02749370|Secondary|Number of Participants With Adverse Events||From first dose of etanercept to 30 days after last dose, up to 28 weeks.|Participants who received at least 1 dose of etanercept during the study.|||Participants|||Count of Participants
2555025|NCT02749370|Secondary|Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 12 and 24|The dermatology life quality index (DLQI) is a skin disease-specific instrument to evaluate health-related quality of life. The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answered 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is from 0 (best possible score) to 30 (worst possible score). Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and weeks 12 and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
2555026|NCT02749370|Secondary|Patient Assessment of Treatment Satisfaction at Week 24|"Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from very dissatisfied to very satisfied."|Week 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||percentage of participants||95% Confidence Interval|Number
2555027|NCT02749370|Secondary|Patient Assessment of Treatment Satisfaction at Week 12|"Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from very dissatisfied to very satisfied."|Week 12|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||percentage of participants||95% Confidence Interval|Number
2555028|NCT02749370|Secondary|"PSI Pain From Skin Lesions Component Score at Each Visit"|Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).|Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2555029|NCT02749370|Secondary|"PSI Flaking of Skin Lesions Component Score at Each Visit"|Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).|Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2555030|NCT02749370|Secondary|"PSI Cracking of Skin Lesions Component Score at Each Visit"|Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).|Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2555031|NCT02749370|Secondary|"PSI Stinging of Skin Lesions Component Score at Each Visit"|Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).|Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2555032|NCT02749370|Secondary|"PSI Burning of Skin Lesions Component Score at Each Visit"|Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).|Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2555033|NCT02749370|Secondary|"PSI Scaling of Skin Lesions Component Score at Each Visit"|Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).|Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2555034|NCT02749370|Secondary|"PSI Redness of Skin Lesions Component Score at Each Visit"|Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).|Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2555035|NCT02749370|Secondary|"PSI Itch From Psoriasis Component Score at Each Visit"|Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).|Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2555036|NCT02749370|Secondary|Psoriasis Symptom Inventory (PSI) Total Score at Each Visit|Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). The total score is the sum of the 8 responses, and ranges from 0 to 32. Higher scores indicate more severe psoriasis.|Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2555037|NCT02749370|Secondary|Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit|A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline value. Last observation carried forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
2555038|NCT02749370|Secondary|Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.|Baseline and weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least I post-baseline sPGA value. Last observation carried forward (LOCF) imputation was used.|||percentage of participants||95% Confidence Interval|Number
2555039|NCT02749370|Secondary|Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.|Baseline and weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline sPGA value. Last observation carried forward (LOCF) imputation was used.|||percentage of participants||95% Confidence Interval|Number
2555040|NCT02749370|Secondary|Static Physician Global Assessment (sPGA) at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).|Weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline sPGA value. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2555041|NCT02749370|Secondary|Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.|Weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline sPGA value. Last observation carried forward (LOCF) imputation was used.|||percentage of participants||95% Confidence Interval|Number
2555042|NCT02749370|Secondary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline sPGA value. Last observation carried forward (LOCF) imputation was used.|||percentage of participants||95% Confidence Interval|Number
2555043|NCT02749370|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)|"The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.~Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement."|Baseline and weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
2555044|NCT02749370|Secondary|Percentage of Participants With a PASI 90 Response at Each Visit|A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (LOCF) imputation was used.|||percentage of participants||95% Confidence Interval|Number
2555045|NCT02749370|Secondary|Percentage of Participants With a PASI 50 Response at Each Visit|A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (LOCF) imputation was used.|||percentage of participants||95% Confidence Interval|Number
2555046|NCT02749370|Secondary|Percentage of Participants With a PASI 75 Response at Each Visit|A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and weeks 4, 8, 12, 16, 20, and 24|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (LOCF) imputation was used.|||percentage of participants||95% Confidence Interval|Number
2555047|NCT02749370|Primary|Percentage of Participants With a PASI 75 Response at Week 12|A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and week 12|Participants who received at least 1 dose of etanercept during the study and with at least 1 post-baseline PASI value. Last observation carried forward (LOCF) imputation was used for participants with missing data at week 12.|||percentage of participants||95% Confidence Interval|Number
2555048|NCT02748928|Secondary|Pain Scale for Rating Discomfort Associated With Treatment|Comfort assessment will be performed independently by the subjects using a numerical scale (0-no discomfort to 10-Worst possible discomfort). The subjects will answer this questionnaire after each of the three treatments.|Day 0 (1st treatment), at 2 weeks (2nd treatment) and at 4 weeks (3rd treatment)||||score on a scale||Standard Deviation|Mean
2555049|NCT02748928|Secondary|Number of Participants Reporting Satisfaction With Treatment Outcome|"Satisfaction assessment will be performed independently by the subjects using a 4-point Likert scale questionnaire from 0 = dissatisfied to 3= very satisfied.~The values in the data table reflect the number of participants who were satisfied or very satisfied (i.e., reported a 2 or 3) with Treatment Outcome, as assessed by the questionnaire."|8, 12 and 16 weeks (from baseline visit)|One participant did not attend the 4 week FU (8 weeks from baseline visit) and three participants did not attend the 8 weeks FU (12 weeks from baseline)|||Participants|||Count of Participants
2555050|NCT02748928|Secondary|Number of Investigators Reporting Satisfaction With Participants' Treatment Outcome|"Satisfaction assessment will be performed independently by the investigator using a 4-point Likert scale questionnaire from 0 = dissatisfied to 3= very satisfied.~The values in the data table reflect the number of Investigators who were satisfied or very satisfied (i.e., reported a 2 or 3) with Participant Treatment Outcome, as assessed by the questionnaire."|8, 12 and 16 weeks (from baseline visit)|One participant did not attend the 4 week FU (8 weeks from baseline visit) and three participants did not attend the 8 weeks FU (12 weeks from baseline)|||Participants|||Count of Participants
2555051|NCT02748928|Secondary|Change in Abdominal Circumference Compared to Baseline|Abdominal circumference change post UltraShape Power treatments|Baseline and at 4, 8, 12 and 16 weeks (from baseline visit)|One participant did not attend the 4 week FU (8 weeks from baseline visit) and three participants did not attend the 8 weeks FU (12 weeks from baseline)|||centimeter||Standard Deviation|Mean
2555052|NCT02748928|Secondary|Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound|Abdominal fat thickness change as measured by ultrasound post UltraShape Power treatments at 4-week, 8-week and 12-week (from baseline visit) versus baseline|Baseline and at 4, 8, and 12 weeks (from baseline visit)|One participant did not attend the 4 week FU (8 weeks from baseline visit) and three participants did not attend the 8 weeks FU (12 weeks from baseline)|||percentage change||Standard Deviation|Mean
2555053|NCT02748928|Primary|Change in Abdominal Fat Thickness Compared to Baseline as Measured by Ultrasound|Abdominal fat thickness change post UltraShape treatments at 12 weeks follow-up (12wk FU) after final treatment versus baseline|Baseline and 16 weeks (4 weeks treatment + 12 week follow up)||||percentage change||Standard Deviation|Mean
2555054|NCT02748889|Primary|Progression Free Survival (PFS) With Carboplatin, Etoposide and MPDL3280A Compared to Chemotherapy Alone According to RECIST v1.1|Disease progression will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and bone scans.|From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years.||||months||Standard Deviation|Mean
2555100|NCT02747004|Secondary|PK: Mean Single Dose Concentration of Tamoxifen and Endoxifen|Mean single dose concentrations of Tamoxifen and its metabolite (Endoxifen) were reported.|Cycle 1 Day 1 post dose|All randomized participants who received at least one dose of study drug along with Tamoxifen and had evaluable PK samples.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2555055|NCT02748863|Primary|Participants With IGA Mod 2011 0 or 1 After 12 Weeks of Treatment|"The Investigator's Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.~Number of participants who achieved IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline"|12 weeks|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.|||participants|||Number
2555056|NCT02748863|Secondary|Number of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response|PASI response over time up to week 52: Number of participants who achieved ≥ 50%, 75%, 90% and 100% reduction in PASI and achieve IGA mod 2011 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline|up to week 52|FAS|||participants|||Number
2555057|NCT02748863|Secondary|Number of Participants With PASI 100 Response After 12 Weeks of Treatment|Participants who achieved 100% reduction in PASI compared to baseline|12 weeks|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.|||participants|||Number
2555058|NCT02748863|Secondary|Participants With PASI 90 After 12 Weeks of Treatment|Number of participants who achieved ≥ 90% and 100% reduction in PASI compared to baseline|12 weeks|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.|||participants|||Number
2555059|NCT02748863|Primary|Participants With Psoriasis Area and Severity Index (PASI) 75 Response After 12 Weeks of Treatment|"Number of participants who achieved ≥ 75% reduction in PASI compared to baseline~PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)."|12 weeks|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.|||participants|||Number
2555060|NCT02748785|Primary|Satisfactory Vaccination Responses Against > 1/3 Antigens|Seroresponse is defined as serconversion or ≥4-fold increase in antibody titers|8 weeks|Per Protocol|||percentage of responders|||Number
2555061|NCT02748785|Primary|Satisfactory Vaccination Responses Against > 2/3 Antigens|Seroresponse is defined as serconversion or ≥4-fold increase in antibody titers|8 weeks|Per Protocol|||percentage of responders|||Number
2555062|NCT02748785|Secondary|DAS28 Flare Rate at Visit 4|DAS28 flare rate at visit 4 as compared to visit 1. RA flare was defined as an increase in DAS28 of >1.2 (or >0.6 if the baseline DAS28 was ≥3.2).|20 weeks from enrollment.||||percentage of flare patients|||Number
2555063|NCT02748785|Secondary|Change From Baseline in Antibody Titer Against B-Yamagata|Fold change = post-vaccination titer/pre-vaccination titer|Day of and 4 weeks after vaccination||||Fold change||95% Confidence Interval|Geometric Mean
2555064|NCT02748785|Secondary|Change From Baseline in Antibody Titer Against H3N2|Fold change = post-vaccination titer/pre-vaccination titer|Day of and 4 weeks after vaccination||||Fold change||95% Confidence Interval|Geometric Mean
2555065|NCT02748785|Secondary|Change From Baseline in Antibody Titer Against H1N1|Fold change = post-vaccination titer/pre-vaccination titer|Day of and 4 weeks after vaccination||||Fold change||95% Confidence Interval|Geometric Mean
2555066|NCT02748785|Secondary|Proportion of Seroprotection Against B-Yamagata|Seroprotection is defined as antibody titers of ≥40|8 weeks||||percentage of patients w/ seroprotection|||Number
2555067|NCT02748785|Secondary|Proportion of Seroprotection Against H3N2|Seroprotection is defined as antibody titers of ≥40|8 weeks||||percentage of patients w/ seroprotection|||Number
2555068|NCT02748785|Secondary|Proportion of Seroprotection Against H1N1|Seroprotection is defined as antibody titers of ≥40|8 weeks||||percentage of patients|||Number
2555069|NCT02748785|Primary|Satisfactory Vaccination Responses Against 3 Antigens|Seroresponse is defined as serconversion or ≥4-fold increase in antibody titers|8 weeks|Per Protocol|||percentage of responders|||Number
2555070|NCT02748525|Secondary|Number of Participants Who Received Cholecystectomy||6 months||||Participants|||Count of Participants
2555071|NCT02748525|Secondary|Number of Participants Who Reported Abdominal Pain at 6 Months|Significant pain scale at follow up was defined as 5 or greater on a scale of 0-10, with 10 being the most severe pain.|6 months||||Participants|||Count of Participants
2555072|NCT02748525|Primary|Gallbladder Ejection Fraction|Patient will receive CCK, be scanned, and the ejection fraction will be measured. Then milk will be administered, repeat scan and ejection fraction will be measured.|45 minutes after milk administration||||percentage of ejection of tracer||Full Range|Mean
2555073|NCT02748525|Primary|Gallbladder Ejection Fraction|Patient will receive CCK, be scanned, and the ejection fraction will be measured.|30 minutes after CCK administration||||percentage of ejection of tracer||Full Range|Mean
2555074|NCT02748356|Secondary|Lactobacillus Tolerability|"This is a one-item satisfaction rating. While thinking only about the preceding 6-month time period: can you estimate, using a scale from 0 to 100%, whether or not you would seek out this intervention and pay for it yourself if insurance did not pay for it? Participants indicated their answer by moving a slider with three anchors: 0%=Would absolutely never do this; 50%=Might do this; 100%= Would absolutely do this. If a participant is less satisfied, their rating will be lower, and if they are more satisfied, the rating would be higher, but the item did not have options for better or worse. This is not a published scale, we included this item in our general data collection.~Ratings averaged over final 12 months of study (Satisfaction question was answered by study participants at 3 time points; 6 months, 12 months and 18 months)"|months 7-18|5 out of 7 children instilled Lactobacillus at least once|||units on a scale||Standard Deviation|Mean
2555076|NCT02748213|Secondary|Duration of Response (DOR) According to RECIST|Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. DOR was defined as the time from first assessment of CR or PR until the first occurrence of documented PD, death, or withdrawal. The median DOR was reported and expressed in months.|Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)|"FAS Population. The Number of Participants Analyzed reflects the number of participants with a best overall response of CR or PR who provided evaluable data for the analysis."|||months||Full Range|Median
2555077|NCT02748213|Secondary|Overall Survival (OS)|OS was defined as the time from start of treatment to date of death for any reason. Participants who were alive at the time of analysis were censored at the latest date of last tumor assessment, last drug intake, or last follow-up information. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.|Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)|FAS Population.|||months||95% Confidence Interval|Median
2555078|NCT02748213|Secondary|Percentage of Participants Who Died|The percentage of participants who died from any cause was reported.|Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)|FAS Population.|||percentage of participants|||Number
2555079|NCT02748213|Secondary|Progression-Free Survival (PFS) According to RECIST|Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. Participants without event at the time of analysis were censored at the latest date of last tumor assessment or last date in drug log. The median duration of PFS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.|Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)|FAS Population.|||months||95% Confidence Interval|Median
2555080|NCT02748213|Secondary|Percentage of Participants With Death or Disease Progression According to RECIST|Tumor response was assessed by RECIST during the study. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants who died or experienced PD was reported.|Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)|FAS Population.|||percentage of participants|||Number
2555081|NCT02748213|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST)|Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a best overall response for CR or PR was reported. The exact 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper method.|Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)|Full Analysis Set (FAS) Population.|||percentage of participants||95% Confidence Interval|Number
2555082|NCT02748057|Secondary|Percentage Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)|Blood was collected at baseline (predose) and after 52 weeks of treatment to determine LDL-C levels. LDL-C was calculated using the Friedewald equation. If triglycerides (TG) exceeded 400 mg/dL (4.6 mmol/L), LDL-C was determined by beta quantification ultracentrifugation. The percentage change from baseline at Week 52 was summarized.|Baseline (predose) and Week 52|All participants that received at least 1 dose of study drug, had baseline data for those analyses that required baseline data and had post-baseline data for endpoint.|||Percentage change||95% Confidence Interval|Mean
2555083|NCT02748057|Primary|Percentage of Participants Who Had Study Drug Discontinued Due to an AE|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who had study drug discontinued due to an AE was summarized.|up to 52 weeks|All participants who received at least 1 dose of study drug during treatment period.|||Percentage of Participants|||Number
2555084|NCT02748057|Primary|Percentage of Participants Who Experience at Least 1 Adverse Event (AE)|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who reported at least 1 AE was summarized.|Up to 2 weeks post last dose of study drug (up to 54 weeks)|All participants who received at least 1 dose of study drug during treatment period.|||Percentage of Participants|||Number
2555101|NCT02747004|Secondary|Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites|"Mean steady state concentrations of Abemaciclib and its metabolites (M2 & M20) are reported.~C=Cycle D= Day"|Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1 post dose|All randomized participants who received at least one dose of study drug and had evaluable PK samples.|||Nanogram per Millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2555102|NCT02747004|Secondary|Pharmacokinetics (PK): Mean Single Dose Concentration of Abemaciclib and Its Metabolites|Mean single dose concentrations of Abemaciclib and its metabolites (M2 & M20) are reported.|Cycle (C) 1 Day (D) 1 post dose|All randomized participants who received at least one dose of study drug and had evaluable PK samples.|||Nanogram per Millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2555085|NCT02747433|Secondary|Change From Baseline in Log Dimensionless Jerk During Reach-to-Target Task|Participants were asked to reach forward from a designated starting position toward a panel with 12 numbered targets positioned in a clockwise-fashion 20 cm from from its center. The center of the target was aligned with the acromion of the paretic arm and reflective markers were attached to locations on the trunk and paretic arm to allow recording of kinematic data via 3-D motion capture (Vicon Motion Systems Ltd. UK) for off-line analysis. Data from reaching movements to all targets were combined for analysis. We report the median values for Log Normalized Jerk, a measure of movement smoothness during reach, for the entire sample at the time of a discharge assessment immediately following the 6-week intervention.|Baseline and immediately after 6-week intervention|Because the primary aim of this pilot was to explore the combined effects of the Active Learning Program for Stroke (ALPS ) and robot-assisted therapy/task oriented training, a decision was made a priori that this data would be collected and analyzed in a pooled manner for this exploratory endpoint.|||dimensionless||Inter-Quartile Range|Median
2555086|NCT02747433|Secondary|Change From Baseline in Movement Time During Reach-to-Target Task|Participants were asked to reach forward from a designated starting position toward a panel with 12 numbered targets positioned in a clockwise-fashion 20 cm from from its center. The center of the target was aligned with the acromion of the paretic arm and reflective markers were attached to locations on the trunk and paretic arm to allow recording of kinematic data via 3-D motion capture (Vicon Motion Systems Ltd. UK) for off-line analysis. Data from reaching movements to all targets were combined for analysis. We report the median values for Movement Time (sec) for the entire sample at the time of a discharge assessment immediately following the 6-week intervention.|Baseline and immediately after 6-week intervention|Because the primary aim of this pilot was to explore the combined effects of the Active Learning Program for Stroke (ALPS ) and robot-assisted therapy/task oriented training, a decision was made a priori that this data would be collected and analyzed in a pooled manner for this exploratory endpoint.|||seconds||Inter-Quartile Range|Median
2555087|NCT02747433|Secondary|Change From Baseline on Stroke Impact Scale (SIS) - Percent Recovery|The SIS measures changes in activity and participation due to stroke. The SIS assesses eight domains including strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory & thinking, and participation/role function. A transformed score for each domain is calculated from its raw score and represented by a 100 point scale, with higher scores representing better performance. We report the participants' rating of stroke recovery (how much the participant feels that he/she has recovered from stroke with 0=no recovery, 100=full recovery), between admission and 1 month follow up assessments to reflect retention of motor function following intervention.|Baseline and 1-month follow-up|Primary aims were to examine the feasibility and effects of the Active Learning Program for Stroke (ALPS) on paretic upper extremity function when combined with either robot-assisted therapy or robot-assisted therapy plus task-oriented training. In the 3rd Arm, data from both groups were combined to examine effects of ALPS + intensive UE training.|||score on a scale||Full Range|Median
2555088|NCT02747433|Secondary|Change From Baseline on Stroke Impact Scale (SIS) - Hand Domain|The SIS measured changes in activity and participation due to stroke. The SIS assesses eight domains including strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory & thinking, and participation/role function. A transformed score for each domain is calculated from its raw score and represented by a 100 point scale, with higher scores representing better performance. We report the change in transformed scores for the hand function domain, between admission and 1 month follow up assessments to reflect retention of motor function following intervention.|Baseline and 1-month follow-up|Primary aims were to examine the feasibility and effects of the Active Learning Program for Stroke (ALPS) on paretic upper extremity function when combined with either robot-assisted therapy or robot-assisted therapy plus task-oriented training. In the 3rd Arm, data from both groups were combined to examine effects of ALPS + intensive UE training.|||score on a scale||Full Range|Median
2555089|NCT02747433|Secondary|Change From Baseline on Modified Ashworth Scale (MAS)|The MAS examined changes in muscle tone in the paretic UE . Scores range from 0=no increase in muscle tone to 4=affected part(s) rigid in flexion or extension. Tested muscle groups include shoulder internal rotators, elbow flexors/extensors, supinators, pronators, wrist flexors/extensors, finger flexors/extensors. Lower scores indicate better motor function. We present the change scores between admission and 1 month follow up assessments to reflect retention of motor function following intervention. .|Baseline and 1-month follow-up|Primary aims were to examine the feasibility and effects of the Active Learning Program for Stroke (ALPS) on paretic upper extremity function when combined with either robot-assisted therapy or robot-assisted therapy plus task-oriented training. In the 3rd Arm, data from both groups were combined to examine effects of ALPS + intensive UE training.|||units on a scale||Full Range|Median
2555090|NCT02747433|Secondary|Change From Baseline on Motor Activity Log (MAL) - How Well (HW) Scale|"The MAL has been widely used in stroke rehabilitation studies to measure self-reported amount and quality of paretic arm use during daily activities. Participant's self-reported amount of use (AOU) and how well the task was performed (HW) are rated on a scale from 0=not used at all to 5=as much or as well as before the stroke. Higher scores indicate greater perceived motor function in the paretic arm & hand.~We report change scores in how well the function was performed between admission and 1 month follow up assessments to reflect retention of motor function following intervention.."|Baseline and 1-month follow-up|Primary aims were to examine the feasibility and effects of the Active Learning Program for Stroke (ALPS) on paretic upper extremity function when combined with either robot-assisted therapy or robot-assisted therapy plus task-oriented training. In the 3rd Arm, data from both groups were combined to examine effects of ALPS + intensive UE training.|||units on a scale||Full Range|Median
2555103|NCT02747004|Secondary|Overall Survival (OS)||Baseline to Death from Any Cause (Approximately 36 Months)|||||||
2555119|NCT02746809|Primary|Device Success Rate|"Device Success defined as:~Absence of procedural mortality, AND~Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND~Intended performance of the prosthetic heart valve, defined as the absence of patient prosthesis-mismatch and mean gradient < 20 mmHg (or peak velocity < 3 m/sec), AND~Absence of moderate or severe prosthetic valve regurgitation"|24 hours to 7 days post implantation||||percentage of participants||95% Confidence Interval|Number
2555120|NCT02746809|Primary|Percentage of Participants With Stroke (Disabling)|Percentage of participants with disabling stroke (VARC-II definitions) at 30 days|30 Days||||percentage of participants||95% Confidence Interval|Number
2555091|NCT02747433|Secondary|Change From Baseline on Motor Activity Log (MAL) - Amount of Use (AOU) Scale|"The MAL has been widely used in stroke rehabilitation studies to measure self-reported amount and quality of paretic arm use during daily activities. Participant's self-reported amount of use (AOU) and how well the task was performed (HW) are rated on a scale from 0=not used at all to 5=as much or as well as before the stroke. Higher scores indicate greater perceived motor function in the paretic arm & hand.~We report change scores in amount of use (AOU) between admission and 1 month follow up assessments to reflect retention of motor function following intervention.."|Baseline and 1-month follow-up|Primary aims were to examine the feasibility and effects of the Active Learning Program for Stroke (ALPS) on paretic upper extremity function when combined with either robot-assisted therapy or robot-assisted therapy plus task-oriented training. In the 3rd Arm, data from both groups were combined to examine effects of ALPS + intensive UE training.|||units on a scale||Full Range|Median
2555092|NCT02747433|Primary|Change From Baseline on Confidence in Arm and Hand Movement (CAHM) Scale|The CAHM is a self-report assessment in which participants are asked to rate their confidence (0-100%) in successfully using their paretic UE for a variety of everyday activities. Change in confidence ratings between baseline, post-intervention and 1-month follow up assessments were examined. A higher score indicates greater confidence. We report change scores between admission and 1 month follow up assessments to reflect retention of scores following intervention.|Baseline and 1-month follow-up|Primary aims were to examine the feasibility and effects of the Active Learning Program for Stroke (ALPS) on paretic upper extremity function when combined with either robot-assisted therapy or robot-assisted therapy plus task-oriented training. In the 3rd Arm, data from both groups were combined to examine effects of ALPS + intensive UE training.|||score on a scale||Full Range|Median
2555093|NCT02747433|Primary|Change From Baseline in Wolf Motor Function Test (WMFT)|The WMFT examined changes in ability to complete timed, functionally-based activities with the paretic UE between baseline, post-intervention and 1-month follow-up assessments. The task rate was calculated as the average # of times that each test item could be completed within 1 minute. Here we report the change in task rate scores between admission and 1 month follow-up assessments to reflect retention of motor function following intervention. A higher number indicates improved task completion.|Baseline and 1-month follow-up|Primary aims were to examine the feasibility and effects of the Active Learning Program for Stroke (ALPS) on paretic upper extremity function when combined with either robot-assisted therapy or robot-assisted therapy plus task-oriented training. In the 3rd Arm, data from both groups were combined to examine effects of ALPS + intensive UE training.|||units on a scale||Full Range|Median
2555094|NCT02747433|Primary|Change From Baseline in Fugl-Meyer Assessment (FMA) - Upper Extremity Subtest|The FMA will examine changes in motor function, pain and sensation in the paretic UE between baseline, post-intervention and 1-month follow-up assessments. The FMA upper extremity subtest contains 33 items, scored as 0= unable, 1=partial ability, 2= faultless with a total possible score of 66 points. Change was calculated as the value at the 1 month follow-up assessment minus the value at baseline to reflect retention of motor function following intervention.|Baseline and 1-month follow-up|Primary aims were to examine the feasibility and effects of the Active Learning Program for Stroke (ALPS) on paretic upper extremity function when combined with either robot-assisted therapy or robot-assisted therapy plus task-oriented training. In the 3rd Arm, data from both groups were combined to examine effects of ALPS + intensive UE training.|||score on a scale||Full Range|Median
2555095|NCT02747186|Primary|Mean Time to Pulpal Response After Maxillary Canine Anesthesia|Subjects' maxillary molar teeth will be tested before anesthetic and every 30 minutes with cold and electronic pulp test for presence of anesthesia as reported by subjects yes or no.|Every 30 minute up to 120 minutes total||||minutes||Standard Deviation|Mean
2555096|NCT02747186|Primary|Mean Time to Pulpal Response After Maxillary Molar Anesthesia|Subjects' maxillary molar teeth will be tested before anesthetic and every 30 minutes with cold and electronic pulp test for presence of anesthesia as reported by subjects yes or no.|Every 30 minutes up to 120 minutes Total||||minutes||Standard Deviation|Mean
2555097|NCT02747004|Secondary|Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)|mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity. In addition to pain intensity (4 items), the mBPI-sf is designed for participants to record the presence of pain in general, pain relief, and pain interference with function (general activity, mood, ability to walk, ability to perform normal work, relations with others, sleep, enjoyment of life). Responses for the mBPI-sf items are captured through the use of 11-point numeric rating scales anchored at 0 (no pain or does not interfere) and 10 (pain as bad as you can imagine or completely interferes). The mBPI-sf recall period is 24 hours and typical completion time for this instrument is less than 5 minutes.|Baseline, 21 Months|All randomized participants who received at least one dose of study drug and had baselines and post baseline mBPI-sf measurement.|||score on a scale||Standard Deviation|Least Squares Mean
2555098|NCT02747004|Secondary|Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)|"The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 items covered by 1 of 3 dimensions:~Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent).~Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much)~Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much).~Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function/QOL or higher levels of symptom burden."|Baseline, 21 Months|All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 score.|||score on a scale||Standard Deviation|Least Squares Mean
2555099|NCT02747004|Secondary|PK: Multiple Dose Concentration of Tamoxifen and Endoxifen|Mean multiple dose concentrations of Tamoxifen and its metabolite (Endoxifen) were reported.|Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1 post dose|All randomized participants who received at least one dose of study drug along with Tamoxifen and had evaluable PK samples.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2555121|NCT02746809|Primary|Percentage of Participants With All-cause Mortality|Percentage of participants with all-cause mortality at 30 days|30 Days||||percentage of participants||95% Confidence Interval|Number
2555104|NCT02747004|Secondary|Duration of Response (DoR)|DoR is defined as the time from the date of first evidence of a CR or PR to the date of objective progression or death from any cause, whichever is earlier as defined by Recist v1.1. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.|Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 21 Months)|"All randomized participants who received at least one dose of study drug and achieved CR or PR.~Censored participants: 9 in Abemaciclib 150 mg + Tamoxifen 20mg; 9 in Abemaciclib 150 mg; 11 in Abemaciclib 200mg."|||Months||95% Confidence Interval|Median
2555105|NCT02747004|Secondary|Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)|Objective response rate was defined as the percentage of participants with CR or PR according to RECIST v1.1. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the LD (longest diameter) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.|Baseline to Objective Disease Progression (Up to 21 Months)|All randomized participants who received at least one dose of study drug and had PR/CR data.|||Percentage of participants||95% Confidence Interval|Number
2555106|NCT02747004|Primary|Progression Free Survival (PFS)|Progression-free survival time was measured from the date of randomization to the date of investigator-determined objective progression as defined by RECIST v1.1, or death from any cause, whichever occurred first. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available.|Baseline to Objective Disease Progression or Death from Any Cause (Up to 21 Months)|All randomized participants who received at least one dose of study drug. Censored participants: 21 in Abemaciclib 150 mg + Tamoxifen 20mg; 25 in Abemaciclib 150 mg; 22 in Abemaciclib 200mg.|||Months||95% Confidence Interval|Median
2555107|NCT02746809|Secondary|Hemodynamic Performance Metrics - Total Prosthetic Regurgitation Graded as None/Trace|Total prosthetic regurgitation (none/trace) as measured by transthoracic echocardiogram and assessed by echo core laboratory|30 days and 6 months|Only participants with echo could be analyzed.|||percentage of participants|||Number
2555108|NCT02746809|Secondary|Hemodynamic Performance Metrics- Aortic Valve Area|Aortic valve area as measured by transthoracic echocardiogram and assessed by echo core laboratory|Baseline, 30 Days, and 6 Months|Only participants with echo could be analyzed.|||cm2||Standard Deviation|Mean
2555109|NCT02746809|Secondary|Hemodynamic Performance Metrics - Mean Gradient|Mean gradient (mmHg) as measured by transthoracic echocardiogram and assessed by echo core laboratory|Baseline, 30 days, and 6 months|Only participants with echo could be analyzed.|||mmHg||Standard Deviation|Mean
2555110|NCT02746809|Secondary|Percentage of Resheath and Recapture Success|"Successful resheathing is defined as Evolut R TAV (including frame) was resheathed into the capsule of the delivery cathether to the desired amount intended, as verified by fluoroscopy.~Successful recapture is defined as the entire Evolut R TAV (including frame) is resheathed into the capsule of the delivery catheter until there is no gap between the capsule and the tip, as verified by fluoroscopy."|Implant procedure|Success could only be analyzed in subjects where the resheath/recapture feature was used.|||percentage of participants|||Number
2555111|NCT02746809|Secondary|Percentage of Subjects With Permanent Pacemaker Implant at 30 Days|Percentage of subjects with new permanent pacemaker implant at 30 days.|30 days|Subjects with pre-existing pacemaker or internal cardiac defibrillator were excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
2555112|NCT02746809|Secondary|Percentage of Subjects With Valve-related Dysfunction Requiring Repeat Procedure|Percentage of subjects with valve-related dysfunction requiring repeat procedure - see VARC-2 definitions for additional details|30 days||||percentage of participants||95% Confidence Interval|Number
2555113|NCT02746809|Secondary|Percentage of Participants With Coronary Artery Obstruction|Percentage of participants with coronary artery obstruction - see VARC-2 definitions for additional details|30 days||||percentage of participants||95% Confidence Interval|Number
2555114|NCT02746809|Secondary|Percentage of Participants With Acute Kidney Injury: Stage 2 or 3|Percentage of participants with Acute Kidney Injury: Stage 2 or 3 - see VARC-2 definitions for additional details|30 days||||percentage of participants||95% Confidence Interval|Number
2555115|NCT02746809|Secondary|Percentage of Participants With Major Vascular Complication|Percentage of participants with Major vascular complication - see VARC-2 definitions for additional details|30 days||||percentage of participants||95% Confidence Interval|Number
2555116|NCT02746809|Secondary|Percentage of Participants With Life Threatening or Disabling Bleeding|Percentage of participants with life threatening or disabling bleeding - see VARC-2 definitions for classification details|30 days post-implantation||||percentage of participants||95% Confidence Interval|Number
2555117|NCT02746809|Secondary|Percentage of Participants With VARC II Combined Safety Endpoint Event at 30 Days|"VARC II composite safety endpoint includes the following components:~All-cause mortality~All stroke (disabling and non-disabling)~Life-threatening bleeding~Acute kidney injury: stage 2 or 3 (including renal replacement therapy).~Coronary artery obstruction requiring intervention.~Major vascular complication.~Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)"|30 days post-implantation||||percentage of participants||95% Confidence Interval|Number
2555118|NCT02746809|Primary|The Percentage of Subjects With no More Than Mild Prosthetic Regurgitation at Early Post Procedure Echocardiogram|The percentage of subjects with no more than mild prosthetic regurgitation at early post procedure echocardiogram as assessed by echo core laboratory|24 hours to 7 days post implantation||||percentage of participants||95% Confidence Interval|Number
2555131|NCT02746679|Secondary|Numbers of Participants With Reformation of Intrauterine Adhesions Were Counted by the Follow-up Hysteroscopy Was Performed in the Third Month After the Surgery||3 months||||participants|||Number
2555122|NCT02746679|Secondary|The Scores of General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks||||units on a scale(t scores)||Standard Deviation|Mean
2555123|NCT02746679|Secondary|The Scores of Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks||||units on a scale(t scores)||Standard Deviation|Mean
2555124|NCT02746679|Secondary|The Scores of Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks||||units on a scale(t scores)||Standard Deviation|Mean
2555125|NCT02746679|Secondary|The Scores of Mental Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks||||units on a scale(t scores)||Standard Deviation|Mean
2555126|NCT02746679|Secondary|The Scores of Vitality Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks||||units on a scale(t scores)||Standard Deviation|Mean
2555127|NCT02746679|Secondary|The Scores of Role-emotional Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks||||units on a scale(t scores)||Standard Deviation|Mean
2555128|NCT02746679|Secondary|The Scores of Role-physical Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks||||units on a scale(t scores)||Standard Deviation|Mean
2555129|NCT02746679|Secondary|The Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)|The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.|Baseline and 8 weeks||||units on a scale(t scores)||Standard Deviation|Mean
2555130|NCT02746679|Secondary|The Zung Self-Rating Depression Scale Scores Before and After the Intervention|The full name of the scale called Zung Self-Rating Depression Scale.The ZSDS includes 10 positively worded items and 10 negatively worded items that assess symptoms of depression. Item responses are ranked from 1 to 4, and higher scores correspond to more frequent symptoms. For each item,patients give a score according to whether the item has occurred: 1 = never/very rarely; 2 = once in a while/some of the time/occasionally; 3 = relatively often/very often/often; 4 = most of the time/always. Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The ZSDS standard scores were used to define four categories of depression severity: within normal range or no significant psychopathology (below 51points); presence of minimal to mild depression (51-60points); presence of moderate to marked depression (61-70points).|Baseline and 8 weeks||||units on a scale(raw scores)||Standard Deviation|Mean
2555132|NCT02746679|Secondary|Menstruation Was Evaluated With Visual Analogue Scale (VAS) in Which the Menstruation Was Assessed by the Patients Themselves With 0 as Amenorrhea and 100 as Normal Menstruation||3 months||||units on a scale||Standard Deviation|Mean
2555133|NCT02746679|Secondary|Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients.||3 months||||mm||Standard Deviation|Mean
2555134|NCT02746679|Primary|The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention|The full name of the scale called Zung Self-Rating Anxiety Scale.The ZSAS contains 20 questions. Each question is scored on a scale of 1-4 (never, some of the time, relatively often, most of the time). Fifteen questions involve the assessment of increasing anxiety levels, and five questions involve decreasing anxiety levels.Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The ZSAS standard scores were used to define four categories of anxiety severity: within normal rangeor no significant psychopathology (25-49points);presence of mild to moderate anxiety levels (50-59points); severe anxiety levels (60-69points); and presence of extreme depression (70-100points).|Baseline and 8 weeks||||units on a scale(raw scores)||Standard Deviation|Mean
2555135|NCT02746627|Secondary|Coping|Responses to Stress Questionnaire measures coping strategies used in response to diabetes-related stress. Scores range from 57-228, and higher scores indicate more responses to stress.|6 months||||score on a scale||Inter-Quartile Range|Median
2555136|NCT02746627|Secondary|Positive Affect|Positive affect measured using the Positive and Negative Affect Scale for children (PANAS-C). The positive affect scale consists of 15 items. Scores range from 15-75, and higher scores indicate higher levels of positive affect.|6 months||||score on a scale||Inter-Quartile Range|Median
2555137|NCT02746627|Secondary|Family Conflict|Diabetes-specific family conflict was measured with the Revised Diabetes Family Conflict Scale, which consists of 19 items regarding how much adolescents and parents argue about diabetes management tasks. Scores range from 19-57, and higher scores indicate greater conflict.|6 months||||score on a scale||Inter-Quartile Range|Median
2555138|NCT02746627|Secondary|Diabetes-Related Quality of Life|The Pediatric Quality of Life (PedsQL) Diabetes-Specific Module assesses adolescents' self-reported quality of life. Scaled scores range from 0-100, with higher scores indicating better quality of life.|6 months||||score on a scale||Inter-Quartile Range|Median
2555139|NCT02746627|Secondary|Frequency of Blood Glucose Monitoring|Glucometer download to determine blood glucose checks per day.|6 months||||blood glucose checks per day||Inter-Quartile Range|Median
2555140|NCT02746627|Primary|Glycemic Control (HbA1c)|HbA1c measured as part of diabetes clinic visit. The target for children and adolescents is <7.5%.|6 months||||percentage of glycated hemoglobin||Inter-Quartile Range|Median
2555141|NCT02746575|Primary|Difference in hscTnI Values|Difference in hscTnI concentrations between preoperative clinic visit and day of surgery|Before surgery and Immediately after surgery (on the day of surgery)|Only patients with complete hscTnI data were inlcuded|||ng/L||Inter-Quartile Range|Median
2555142|NCT02746406|Primary|Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary.|Each participant could score between 0 and 39 and the total score range for group is 0 to 195. All questionnaires and patient diary questions were summed across the board for patients to derive a total score for the Arm/Group|Through study completion, an average of 4 days||||participants|||Number
2555143|NCT02746263|Primary|Pain Intensity on a Numerical Pain Scale (NPS) for 18 Hours|Participants rate intensity of their pain on a Numerical Pain Scale (NPS) from 0-10, wherein 0=no pain (better) and 10=most intense pain (worse). The highest possible score is 10.|18 hours|Per Protocol Analysis Set - The single participant enrolled was in violation of the protocol, leading to unreliable or uninterpretable data.||||||
2555144|NCT02746107|Other Pre-specified|Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the CHA2D2s-VASC Risk Score|The proportion of OAC prescription for the range 1-5 of CHA2D2s-VASC scores. CHA2D2S-VASC risk score ranges from 1-5, with higher scores indicating a greater risk of stroke.|5 min||||participants|||Number
2555145|NCT02746107|Other Pre-specified|Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Target of Prescription (Patient vs. Physician Himself)|the participant physicians were randomized to prescribe to virtual patients or to imagine that the risk seen in the diagram was that of themselves|5 min||||participants|||Number
2555146|NCT02746107|Other Pre-specified|Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Timeframe for Risk Presentation (1 vs 5 Years)|the proportion of physicians deciding to prescribe OAC after seeing risk estimation on 1 vs 5 years|5 minutes||||participants|||Number
2555147|NCT02746107|Primary|Number of Participants Who Prescribed Oral Anticoagulants (OAC) According to the Number of Decision Aid Diagrams|after regarding the risk diagram, the physician will decide to prescribe/take or not the treatment|after seeing the decision aid (5 min)||||participants|||Number
2555148|NCT02745626|Secondary|Amount of Root Resorption Observed for Maxillary Second Premolar = Length of Root at T0-Length of Root at T2 (in mm)|Root resorption was analyzed by comparing the root length before (T0) treatment and after 18 months of treatment( T2)|T0-T2: 18 months of treatment||||millimeter (mm)||Standard Deviation|Mean
2555149|NCT02745626|Secondary|Amount of Root Resorption Observed for Maxillary Lateral Incisor = Length of Root at T0-Length of Root at T2 (in mm)|Root resorption was analyzed by comparing the root length before (T0) treatment and after 18 months of treatment( T2). Therefore the data values indicate the difference in the root length ( in mm).|T0-T2: 18 months of treatment||||millimeter (mm)||Standard Deviation|Mean
2555150|NCT02745626|Secondary|S.Mutans Count|To calculate the bacterial counts from the diluted plates back to baseline undiluted values, the measurement obtained from the diluted plate was multiplied by 10n (n = number of the serial dilution)|T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment||||CFU/ml||Standard Deviation|Mean
2555151|NCT02745626|Secondary|Total Bacterial Count|To calculate the bacterial counts from the diluted plates back to baseline undiluted values, the measurement obtained from the diluted plate was multiplied by 10n (n = number of the serial dilution).|T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment||||CFU/ml||Standard Deviation|Mean
2555152|NCT02745626|Secondary|Bleeding Index|"An evaluation of the amount of inflammation.~The following scores were used:~0 no bleeding~singular bleeding point~several bleeding points or a thin bleeding line along the marginal gingiva~bleeding in the entire interdental gingival triangle immediately after probing~profuse bleeding during probing, bleeding extending over the marginal gingiva eventually with development of blood drops"|T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment||||Bleeding index (BI)||Standard Deviation|Mean
2555153|NCT02745626|Secondary|Gingival Index|"An evaluation of the gingival architecture . The following scores were used :~0 Physiologic gingiva~Mild inflammation (slight color change and little change in texture)~Moderate inflammation (moderate glazing, redness, edema and hypertrophy, bleeding on probing)~Severe inflammation (marked redness and hypertrophy, ulceration. tendency to bleed spontaneously)"|T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment||||Gingival Index (GI)||Standard Deviation|Mean
2555154|NCT02745626|Primary|Plaque Index|"A measure of the plaque levels on the desired tooth surface. The following scores were used:~0 no plaque/debris on inspection and probing~thin film of plaque only visible after probing~ribbon-like layer of plaque covering the sulcus & gingival crown areas but not filling interdental space~thick layer of plaque already visible at inspection and filling interdental space"|T0: Before treatment; T1: 9 months of treatment; T2: 18 months of treatment||||Plaque Index (PI)||Standard Deviation|Mean
2555155|NCT02745535|Secondary|Number of Participants Who Achieve Sustained Virologic Response (SVR) 24 Weeks After Completion of Therapy.|Per protocol analysis. Sustained Virologic Response as measure by an undetectable HCV RNA level 24 weeks after completion of therapy.|Post-treatment week 24||||Participants|||Count of Participants
2555156|NCT02745535|Secondary|Number of Participants Who Achieve Sustained Virologic Response (SVR) 4 Weeks After Completion of Therapy.|Per protocol analysis. Sustained Virologic Response as measure by an undetectable HCV RNA level 4 weeks after completion of therapy.|Post-treatment week 4||||Participants|||Count of Participants
2555157|NCT02745535|Secondary|Number of Participants Who Achieve End of Treatment Virologic Response (ETR) at Completion of Therapy.|Per protocol analysis. End of Treatment Virologic Response as measure by an undetectable HCV RNA level completion of therapy.|Week 12||||Participants|||Count of Participants
2555158|NCT02745535|Primary|Number of Participants Who Achieve Sustained Virologic Response (SVR) 12 Weeks After Completion of Therapy (SVR12)|Intention to treat (ITT) analysis. Sustained Virologic Response as measure by an undetectable HCV RNA level 12 weeks after completion of therapy.|Post-treatment week 12|All participants who took at least one dose of study medication.|||Participants|||Count of Participants
2555159|NCT02745535|Primary|Number of Participants With Grade 3 and 4 Adverse Events|Number of participants with grade 3 and 4 adverse events during treatment with and/or within 30 of completion of SOF/VEL/VOX in HCV infected|up to 16 weeks|All participants who received at least one dose of treatment.|||Participants|||Count of Participants
2555160|NCT02745392|Primary|Proportion of Subjects With Freedom From Most Bothersome Pre-specified Other Symptom (Nausea, Photophobia, or Phonophobia Pre-specified by Subject)|The proportion of subjects with freedom from the subject's pre-specified most bothersome symptom at 2 hours is one of two parts of the co-primary efficacy endpoint. This endpoint will be evaluated separately but both endpoints have to be met statistically for the study to be considered a success.|2 hours|mITT|||Participants|||Count of Participants
2555161|NCT02745392|Primary|Proportion of Subjects With Pain Freedom|Pain Freedom at 2 hours post study drug administration is one of the co-primary endpoints. Subjects were queried via their eDiary about their level of migraine pain (none, mild, moderate, or severe) at various intervals post-dose. Subjects who answered none at 2 hours post study drug were considered pain free at 2 hours.|2 hours|mITT population includes all subjects who were randomized, received any amount of study drug (applied the patch(es) to treat a qualifying migraine, and had at least 1 post-treatment efficacy assessment|||Participants|||Count of Participants
2555162|NCT02745353|Primary|Number of Participants That Completed Naloxegol 25mg and the Number of Participants That Completed Standard of Care|completion of treatment defined as participants receiving all single daily doses for 2 weeks|4 weeks||||Participants|||Count of Participants
2555163|NCT02745145|Secondary|Number of Participants With Absolute Decrease From Baseline of FVC Percentage (%) Predicted Greater Than or Equal to (>=) 10% on 2 or More Consecutive Occasions at Least 4 Weeks Apart|FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. The FVC assessments were done using spirometry.|upto Week 52|mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo).|||Participants|||Count of Participants
2555164|NCT02745145|Secondary|Number of Participants With Clinically Meaningful Progression|Participants meeting one or both of the below criteria was considered as having clinically meaningful disease progression. Clinically Meaningful SSc-ILD defined as one of the following (in the absence of causative intercurrent illness) on at least 2 occasions within approximately 4 weeks (per Outcome Measures in Rheumatology criteria): Relative decrease from baseline in forced vital capacity (FVC) % predicted greater than or equal to (>=)10%; Relative decrease from baseline in FVC % predicted of >=5% to less than (<) 10% and relative decrease from baseline in Diffusion capacity of the lung for carbon monoxide % predicted >=15%. Clinically Meaningful SSc progression other than ILD defined as new onset of one or more of the following: Scleroderma renal crisis; Left ventricular failure (defined as ejection fraction <=45%); Pulmonary arterial hypertension requiring treatment.|upto Week 52|mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo).|||Participants|||Count of Participants
2555165|NCT02745145|Secondary|Number of Participants With Clinically Meaningful Progression of Systemic Sclerosis (SSc) by Meeting Criterion 2 (SSc Progression Other Than ILD)|Clinically Meaningful Progression SSc other than ILD was defined as new onset of one or more of the following: Scleroderma renal crisis; Left ventricular failure (defined as ejection fraction <=45%); Pulmonary arterial hypertension requiring treatment.|upto Week 52|mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo).|||Participants|||Count of Participants
2555249|NCT02743780|Secondary|Part 1: Area Under the Concentration-time Curve From 0 to Infinity [AUCinf (ng*h/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was to be collected at each time point.|Pre-dose to 120 hours post-dose|Due to the low exposure and the limit of LLOQ (0.05 ng/mL), none of the observed individual profiles could generate valid AUCinf.||||||
2555166|NCT02745145|Secondary|Number of Participants With Clinically Meaningful Progression of Systemic Sclerosis (SSc) by Meeting Criterion 1 (Interstitial Lung Disease [ILD])|Clinically Meaningful Progression SSc-ILD was defined as one of the following (in the absence of causative intercurrent illness) on at least 2 occasions within approximately 4 weeks (per Outcome Measures in Rheumatology criteria): Relative decrease from baseline in forced vital capacity (FVC) % predicted greater than or equal to (>=)10%; Relative decrease from baseline in FVC % predicted of >=5% to less than (<) 10% and relative decrease from baseline in Diffusion capacity of the lung for carbon monoxide % predicted >=15%.|upto Week 52|mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo).|||Participants|||Count of Participants
2555167|NCT02745145|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number participants who died and number of censored participants.|Time from date of randomization until death, assessed up to 2 years|mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo).|||Participants|||Count of Participants
2555168|NCT02745145|Secondary|Absolute Change From Baseline in Quantitative Lung Fibrosis (QLF) in the Region of Highest Baseline Severity at Week 52|Absolute change from baseline in QLF score at week 52 was calculated as the difference of the QLF score at week 52 minus the QLF score at baseline divided in the region of highest baseline severity at Week 52 .The QLF score itself ranges from 0 to 100, where greater values represent a greater amount of lung fibrosis and are considered a worse health status.|Baseline, Week 52|"mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo). Here, Overall Number of Participants Analyzed signified number of participants evaluable for the outcome measure. All participants for abituzumab 500 mg arm dropped out before the analysis was conducted."|||Scores on a scale||Standard Deviation|Mean
2555169|NCT02745145|Secondary|Absolute Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 52 in Participants With Diffuse Cutaneous Skin Involvement at Baseline|The Modified Rodnan Skin Score (mRSS) measures dermal skin thickness through the examination of 17 body areas: fingers, hands, forearms, arms, feet, legs, and thighs (in pairs), and face, chest, and abdomen. The skin score is evaluated by manual palpation in each of these areas. The skin score is 0 for uninvolved skin, 1 for mild thickening, 2 for moderate thickening, and 3 for severe thickening (hidebound skin). The total skin score is the sum of the skin scores of the individual areas where the minimum score is 0 and the maximum score is 51. A higher score indicates greater severity of disease.|Baseline, Week 52|"mITT diffuse cutaneous systemic sclerosis population from mITT analysis set who had diffuse cutaneous skin involvement at baseline. Here, Overall Number of Participants Analyzed signified participants evaluable for the outcome measure. All participants for abituzumab 500 mg and abituzumab 1500 mg arm dropped out before the analysis was conducted."|||Scores on a scale||Standard Deviation|Mean
2555170|NCT02745145|Secondary|Absolute Change From Baseline in St. George Respiratory Questionnaire (SGRQ) Total Score at Week 52|The SGRQ assesses health-related quality of life in participants with chronic pulmonary disease by evaluating 3 health domains: symptoms (distress caused by respiratory symptoms); activity (effects of disturbances on mobility and physical activity); and impacts (the effect of disease on factors such as employment, personal control of one's health, and need for medication). A composite total score is derived as the weighted sum of domain scores for symptoms, activity, and impact (0=the best possible score and 100=the worst possible score). A reduction in score of 4 units is generally recognized as a clinically meaningful improvement in quality of life.|Baseline, Week 52|"mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo). Here, Overall Number of Participants Analyzed signified number of participants evaluable for the outcome measure. All participants for abituzumab 500 mg arm dropped out before the analysis was conducted."|||Scores on a scale||Standard Deviation|Mean
2555171|NCT02745145|Secondary|Change From Baseline in Dyspnea as Measured by the Mahler's Transition Dyspnea Index (TDI) at Week 52|Mahler's TDI was an interview-administered instrument that allows participants to assess their level of dyspnea which was assessed by functional impairment, magnitude of task and magnitude of effort. Scores for each subscale range from -3 to +3 so that the TDI focal score ranges from -9 (major deterioration) to +9 (major improvement). For all subscale scores and the TDI focal score a higher value indicates a better outcome.|Baseline, Week 52|"mITT population was defined as all randomized participants who receive at least 1 dose of study drug (including placebo). Here, Overall Number of Participants Analyzed signified number of participants evaluable for the outcome measure. All participants for abituzumab 500 mg arm dropped out before the analysis was conducted."|||Score on a scale||Standard Deviation|Mean
2555172|NCT02745145|Primary|Change From Baseline in Absolute Forced Vital Capacity (FVC) at Week 52|FVC was the maximum amount of air exhaled from the lungs after taking the deepest breath possible. The FVC assessments were done using spirometry. Change from baseline in fvc at week 52 was reported.|Baseline, Week 52|"Modified intent-to-treat (mITT) population was defined as all randomized participants who received at least 1 dose of study drug (including placebo). Here, Overall Number of Participants Analyzed signified participants evaluable for the outcome measure. All participants for abituzumab 500 mg arm dropped out before the analysis was conducted."|||milliliters||Standard Deviation|Mean
2555173|NCT02745119|Primary|Percentage of Participants With Anti-Lampalizumab Antibodies|The immunogenicity analysis included participants with at least one predose and one postdose anti-lampalizumab antibodies assessment. Predose was defined as prior to the first dose in the extension study for the prior sham participants, and prior to the first dose in the parent study for the prior lampalizumab participants.|Week 48|The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study. Data is reported for evaluable participants.|||percentage of participants|||Number
2555174|NCT02745119|Primary|Percentage of Participants With Systemic (Non-Ocular) AEs by Severity|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test.|Up to approximately one year|The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.|||percentage of participants|||Number
2555175|NCT02745119|Primary|Percentage of Participants With Ocular Adverse Events (AEs) by Severity|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.|Up to approximately one year|The safety-evaluable population included all participants who enrolled in the extension study and received at least one lampalizumab injection in the extension study.|||percentage of participants|||Number
2555176|NCT02744898|Secondary|Percent Progression Free Survival|This will be measured by the Kaplan-Meier curve and progression free survival rates.|60 months|||||||
2555177|NCT02744898|Secondary|Survival|This will be measured by the Kaplan-Meier curve and progression free survival rates|60 months|||||||
2555178|NCT02744898|Primary|Tolerability Measured Completion of Dose Regimen|Tolerability for an individual patient will be defined as remaining on the study for 6 cycles with two or fewer dose reductions.|24 months||||Participants|||Count of Participants
2555179|NCT02744846|Primary|Body Mass Index Z-score Difference at 10 Years, Exposed vs. No Antibiotics Less Than 24 Months|BMI measured at 10 years Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Positive values below indicate a higher BMI z-score in children who received antibiotics versus those who did not.|10 years||||BMI z-score units||95% Confidence Interval|Mean
2555180|NCT02744846|Primary|Body Mass Index Z-score Difference at 48-72 Months, Exposed vs. No Antibiotics Less Than 24 Months|BMI z-score measured between 48-72 months Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Positive values below indicate a higher BMI z-score in children who received antibiotics versus those who did not.|48-72 Months||||BMI z-score units||95% Confidence Interval|Mean
2555181|NCT02744755|Secondary|Study Period 2: Incidence of Injection Site Reactions in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira|Incidence of injection site reactions|up to 48 weeks|Safety Set|||Participants|||Count of Participants
2555182|NCT02744755|Secondary|Study Period 2: Changes From Week 24 at Week 48 in DAS28-CRP and DAS28-ESR Scores in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira|"DAS28-CRP is a disease activity score and defined in primary outcome measure. DAS28-ESR is the DAS28 erythrocyte sedimentation rate score.~DAS28-CRP and DAS28-ESR:~best is 0,~< 2.6 - remission,~≥ 2.6 to ≤ 3.2 - low disease activity~> 3.2 to ≤ 5.1 - moderate disease activity~> 5.1 - high disease activity~DAS28-ESR = 0.56 * sqrt(tender28) + 0.28* sqrt(swollen28) + 0.7 * ln(ESR) + 0.014 * GDA where • tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count • CRP is C-reactive protein (mg/l) • ESR is erythrocyte sedimentation rate (mm/h) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm.Values range from 0 to 10. Higher values mean a higher disease activity."|week 48|Treatment period 2 per protocol set. Patients with data available|||score on a scale||Standard Deviation|Mean
2555183|NCT02744755|Secondary|Study Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT©) Fatigue Scale Changes From Week 24 at Week 48 in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira|FACIT©: from 0 (worst) to 52 (best), a score of less than 30 indicates severe fatigue|week 48|Treatment period 2 per protocol set. Patients with data available|||score on a scale||Standard Deviation|Mean
2555184|NCT02744755|Secondary|Study Period 2 :Proportion of Patients Treated Continuously With GP2017 and Patients Treated With GP2017 After Switch From Humira Achieving HAQ-DI© Score in Normal Range ≤0.5 at Week 48||week 48|Treatment period 2 per protocol set. Patients with data available|||Participants|||Count of Participants
2555185|NCT02744755|Secondary|Study Period 2 - Health Assessment Questionnaire-Disability Index (HAQ-DI©) Changes From Week 24 at Week 48 in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira|Health assessment questionnaire (HAQ-DI) disability index ranges from 0 (best) to 3 (worst)|Weeks 48|Treatment period 1 per protocol set. Patients with data available|||score on a scale||Standard Deviation|Mean
2555186|NCT02744755|Secondary|Study Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Week 48, in Patients Treated With GP2017 Who Continued GP2017 or Switched to GP2017 From Humira||week 48|Treatment period 2 per protocol set. Patients with data available|||Participants|||Count of Participants
2555187|NCT02744755|Secondary|Study Period 2 - Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Formation Against Adalimumab in Patients Treated With GP2017 Who Continued GP2017 or Switched to GP2017 From Humira (Positive Patients)|Frequency of patients having anti-drug antibody (ADA) during 24 weeks|week 24, week 36, week 48|Safety Set|||Participants|||Count of Participants
2555188|NCT02744755|Secondary|Study Period 1 - Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Formation Against Adalimumab in Patients Treated With GP2017 or Humira (Positive Patients)|Frequency of patients having anti-drug antibody (ADA) during 24 weeks|baseline, week 2, week 4, week 12, week 24|Safety Set|||Participants|||Count of Participants
2555189|NCT02744755|Secondary|Study Period 1: Incidence and Severity of Injection Site Reactions in GP2017 and Humira|Incidence of injection site reactions in GP2017 and Humira|Treatment Period 1, 24 weeks|Safety Set|||Participants|||Count of Participants
2555190|NCT02744755|Secondary|Study Period 1 -ESR (Erythrocyte Sedimentation Rate) Changes From Baseline in GP2017 and US-licensed Humira Treated at Weeks 4, 12 and 24|Outcome measure 13 presents changes in ESR measures in blood while outcome measure 7 presents changes in DAS28-ESR scores (calculated composite score to measure the disease activity)|Week 4, week 12, week 24|Treatment period 1 per protocol set. Patients with data available|||mm/h||Standard Deviation|Mean
2555191|NCT02744755|Secondary|Study Period 1 - CRP (C-reactive Protein) Changes From Baseline in GP2017 and US-licensed Humira Treated at Weeks 4, 12 and 24|Outcome measure 13 presents changes in CRP measures in blood while Outome measure 7 presents changes in DAS28-CRP scores (calculated composite score to measure the disease activity)|Week 4, week 12, week 24|Treatment period 1 per protocol set. Patients with data available|||mg/L||Standard Deviation|Mean
2555192|NCT02744755|Secondary|Study Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT©) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24 (Change From Baseline)|FACIT© fatigue scale is a 13- item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function, ranging from 0 (worst) to 52 (best).|Weeks 4, 12 and 24;|Treatment period 1 per protocol set. Patients with data available|||score on a scale||Standard Deviation|Mean
2555193|NCT02744755|Secondary|Study Period 1- Proportion of Patients Achieving HAQ-DI© Score Improvement >0.3 at Weeks 4, 12 and 24|Health assessment questionnaire (HAQ-DI©) disability index ranges from 0 (best) to 3 (worst)|Weeks 4, 12 and 24;|Treatment period 1 per protocol set. Patients with data available|||Participants|||Count of Participants
2555194|NCT02744755|Secondary|Study Period 1- Proportion of Patients Achieving HAQ-DI© in Normal Range (≤ 0.5) at Weeks 4, 12 and 24;|Health assessment questionnaire disability index (HAQ-DI©) ranges from 0 (best) to 3 (worst)|Weeks 4, 12 and 24;|Treatment period 1 per protocol set. Patients with data available|||Participants|||Count of Participants
2555195|NCT02744755|Secondary|Study Period 1 - Changes From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI©) at Weeks 4, 12 and 24;|"Health assessment questionnaire (HAQ-DI) disability index ranges from 0 (best) to 3 (worst).The HAQ© was scored in accordance with the recommendation from the developers outlined in the HAQ PACK from Stanford University, California.~Ramey Dr, Fries JF, Singh G. in B. Spilker Quality of Life and Pharmacoleconomics in Clinical Trials, 2nd ed, The Health Assessment Questionnaire 1995 -- Status and Review. Philadelphia: Lippincott-Raven Pub., 1996, p 227 - 237.~Fries JF, Spitz P, Kraines G, Holman H. Measurement of Patient Outcome in Arthritis, Arthritis and Rheumatism, 1980, 23:137-145."|Weeks 4, 12 and 24;|Treatment period 1 per protocol set. Patients with data available|||score on a scale||Standard Deviation|Mean
2555196|NCT02744755|Secondary|Study Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24|"ACR20 response was defined if a patient fulfilled all 3 criteria below: -at least 20% improvement in tender 68 joint count~-at least 20% improvement in swollen 66 joint-count; And at least 20% improvement in at least 3 of the following 5 measures: - Patient's assessment of RA pain (visual analogue scale (VAS) 100 mm), -Patient's global assessment of disease activity (VAS 100 mm), -Physician's global assessment of disease activity (VAS 100 mm), -Patient self-assessed disability index(HAQ-DI© score), -Acute phase reactant (CRP or ESR). ACR50 and ACR70 responses were defined as ACR20 response replacing 20% improvement by 50% improvement and 70% improvement, respectively."|Week 4, week 12 and week 24|Treatment period 1 per protocol set. Patients with data available|||Participants|||Count of Participants
2555197|NCT02744755|Secondary|Study Period 1: Change in DAS28-CRP and DAS28-ESR Scores From Baseline to Week 24 in Patients Treated With GP2017 and Patients Treated With Humira|"DAS28-CRP is a disease activity score and defined in primary outcome measure. DAS28-ESR is the DAS28 erythrocyte sedimentation rate score.~DAS28-CRP and DAS28-ESR:~best is 0,~< 2.6 - remission,~≥ 2.6 to ≤ 3.2 - low disease activity~> 3.2 to ≤ 5.1 - moderate disease activity~> 5.1 - high disease activity~DAS28-ESR = 0.56 * sqrt(tender28) + 0.28*sqrt(swollen28) + 0.7 * ln(ESR) + 0.014 * GDA where • tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count • CRP is C-reactive protein (mg/l) • ESR is erythrocyte sedimentation rate (mm/h) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm.Values range from 0 to 10. Higher values mean a higher disease activity."|study period 1: week 2, 4, 24|Treatment Period 1 Per-Protocol set|||scores on a scale||Standard Error|Least Squares Mean
2555198|NCT02744755|Secondary|Study Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria|Proportion of patients achieving EULAR/American College of Rheumatology (EULAR/ACR) Boolean remission criteria (defined as number of tender joint count 28 <=1 and swollen joint count 28 <=1, CRP level (mg/dL) <=1 and patient's global assessment <=1 on a scale of 1-10 (corresponding to <=10 on a scale of 1-100).|week 4, week 12, week 24|Treatment period 1 per protocol set. Patients with data available|||Participants|||Count of Participants
2555199|NCT02744755|Secondary|Study Period 1- Proportion of Patients Achieving EULAR Criterion for Moderate Response|Proportion of patients achieving European League against Rheumatism (EULAR) moderate response (defined as DAS28<=3.2 at post-baseline assessment timepoint(s) with an improvement of >0.6 to <=1.2 from baseline or DAS28 >3.2 to <=5.1 with an improvement of >0.6 to <=1.2 or of >1.2 from baseline or DAS28 >5.1 with an improvement of >1.2 from baseline) ;|week 4, week 12 and week 24|Treatment period 1 per protocol set. Patients with data available|||Participants|||Count of Participants
2555200|NCT02744755|Secondary|Study Period 1- Proportion of Patients Achieving EULAR Criterion for Good Response|Proportion of patients achieving European League against Rheumatism (EULAR) good response (defined as DAS28<=3.2 at post-baseline assessment timepoint(s) with an improvement of >1.2 in DAS28 from baseline.)|week 4, week 12 and week 24|Treatment period 1 per protocol set. Patients with data available|||Participants|||Count of Participants
2555201|NCT02744755|Secondary|Study Period 1- Proportion of Patients Achieving EULAR Criterion for Remission|Proportion of patients achieving European League against Rheumatism (EULAR) remission (defined as DAS28 CRP < 2.6 )|week 4, week 12 and week 24|Treatment period 1 per protocol set. Patients with data available|||Participants|||Count of Participants
2555202|NCT02744755|Secondary|Study Period 1: Time-weighted Averaged Change From Baseline in DAS28-CRP Until Week 24 in Patients Treated With GP2017 and With Humira|Disease activity score (DAS) 28-CRP is based on 28-joint count (tender and swollen joints), C-reactive protein and patient's assessment of global disease activity (GDA) or general health (GH), values range from 0.96 to 10.0 while higher values mean a higher disease activity. • A DAS28-CRP value >5.1 corresponds to a high disease activity • A DAS28-CRP value between 3.2 and 5.1 corresponds to a moderate disease activity • A DAS28-CRP value between 2.6 and 3.2 corresponds to a low disease activity • A DAS28-CRP value < 2.6 corresponds to remission DAS28-CRP = 0.56 * sqrt(tender28) + 0.28* sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * GDA or GH + 0.96 where • tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count • CRP is C-reactive protein (mg/l) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm|Study period 1: week 24|Treatment Period 1 Per-Protocol set|||scores on a scale||Standard Error|Least Squares Mean
2555324|NCT02742766|Primary|Part 3: Number of Participants With Abnormal Findings in Physical Examination|Part 3 was planned as a 28-day, repeat dose study in obese participants; however, since a tolerable dose with sufficient pharmacodynamic effects was not identified, this portion of the study was not conducted.|Up to Day 36|Safety Population.||||||
2555203|NCT02744755|Primary|Study Period 1: Change in DAS28-CRP Score From Baseline at Week 12 in Patients Treated With GP2017 and Patients Treated With Humira|Disease activity score (DAS) 28-CRP is based on 28-joint count (tender and swollen joints), C-reactive protein and patient's assessment of global disease activity (GDA) or general health (GH), values range from 0.96 to 10.0 while higher values mean a higher disease activity. • A DAS28-CRP value >5.1 corresponds to a high disease activity • A DAS28-CRP value between 3.2 and 5.1 corresponds to a moderate disease activity • A DAS28-CRP value between 2.6 and 3.2 corresponds to a low disease activity • A DAS28-CRP value < 2.6 corresponds to remission DAS28-CRP = 0.56 * sqrt(tender28) + 0.28* sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * GDA or GH + 0.96 where • tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count • CRP is C-reactive protein (mg/l) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm|Study period 1: week 12|Treatment Period 1 Per-Protocol set|||scores on a scale||Standard Error|Least Squares Mean
2555204|NCT02744534|Primary|Percentage of Cores Positive for Cancer|The cancer detection rate per core was compared between the targeted prostate biopsy and standard of care prostate biopsy.|Two weeks|All 21 participants are included in the analysis, and all participants had both types of biopsies performed. The total number of core samples taken during biopsy are given as the overall number of participants analyzed and the percentage of these core samples that tested positive for prostate cancer are given as the outcome measure data.|||percentage of positive core samples|Prostate biopsy core samples||Number
2555205|NCT02744391|Secondary|Post-Treatment [11C]-Raclopride Binding Potential: Associative Striatum|Subjects received 2 [11C]-raclopride positron emission tomography (PET) scans: baseline and post-L-DOPA treatment. High resolution anatomical T1-weighted MRI scans were acquired for each subject and PET data were co-registered to the MRIs using maximization of mutual information (SPM12, Wellcome Centre for Human Neuroimaging). Regions of interest (ROIs) were applied to the MRIs and transferred to the PET data and included the sensorimotor striatum (post-commissural putamen, SMST), associative striatum (whole caudate and pre-commissural putamen, AST) and the limbic striatum (nucleus accumbens and the most ventral aspects of the pre-commissural caudate and putamen, LST). Additionally, an ROI was drawn on cerebellum as a reference tissue. ROI time activity curves were derived as the average activity in each ROI in each frame. The primary outcome measure was BPND, the binding potential with respect to the non-displaceable compartment, derived by the simplified reference tissue model.|Week 3|47 patients were enrolled and 36 patients were analyzed according to the intent to treat analysis. Only 10 subjects were scanned in this study.|||mCi/ ml||Standard Deviation|Mean
2555206|NCT02744391|Secondary|Pre-Treatment [11C]-Raclopride Binding Potential: Associative Striatum|Subjects received 2 [11C]-raclopride positron emission tomography (PET) scans: baseline and post-L-DOPA treatment. High resolution anatomical T1-weighted MRI scans were acquired for each subject and PET data were co-registered to the MRIs using maximization of mutual information (SPM12, Wellcome Centre for Human Neuroimaging). Regions of interest (ROIs) were applied to the MRIs and transferred to the PET data and included the sensorimotor striatum (post-commissural putamen, SMST), associative striatum (whole caudate and pre-commissural putamen, AST) and the limbic striatum (nucleus accumbens and the most ventral aspects of the pre-commissural caudate and putamen, LST). Additionally, an ROI was drawn on cerebellum as a reference tissue. ROI time activity curves were derived as the average activity in each ROI in each frame. The primary outcome measure was BPND, the binding potential with respect to the non-displaceable compartment, derived by the simplified reference tissue model.|Baseline|47 patients were enrolled and 36 patients were analyzed according to the intent to treat analysis. Only 10 subjects were scanned in this study.|||mCi/ ml||Standard Deviation|Mean
2555207|NCT02744391|Secondary|Post-Treatment [11C]-Raclopride Binding Potential: Limbic Striatum|Subjects received 2 [11C]-raclopride positron emission tomography (PET) scans: baseline and post-L-DOPA treatment. High resolution anatomical T1-weighted MRI scans were acquired for each subject and PET data were co-registered to the MRIs using maximization of mutual information (SPM12, Wellcome Centre for Human Neuroimaging). Regions of interest (ROIs) were applied to the MRIs and transferred to the PET data and included the sensorimotor striatum (post-commissural putamen, SMST), associative striatum (whole caudate and pre-commissural putamen, AST) and the limbic striatum (nucleus accumbens and the most ventral aspects of the pre-commissural caudate and putamen, LST). Additionally, an ROI was drawn on cerebellum as a reference tissue. ROI time activity curves were derived as the average activity in each ROI in each frame. The primary outcome measure was BPND, the binding potential with respect to the non-displaceable compartment, derived by the simplified reference tissue model.|Week 3|47 patients were enrolled and 36 patients were analyzed according to the intent to treat analysis. Only 10 subjects were scanned in this study.|||mCi/ ml||Standard Deviation|Mean
2555208|NCT02744391|Secondary|Pre-Treatment [11C]-Raclopride Binding Potential: Limbic Striatum|Subjects received 2 [11C]-raclopride positron emission tomography (PET) scans: baseline and post-L-DOPA treatment. High resolution anatomical T1-weighted MRI scans were acquired for each subject and PET data were co-registered to the MRIs using maximization of mutual information (SPM12, Wellcome Centre for Human Neuroimaging). Regions of interest (ROIs) were applied to the MRIs and transferred to the PET data and included the sensorimotor striatum (post-commissural putamen, SMST), associative striatum (whole caudate and pre-commissural putamen, AST) and the limbic striatum (nucleus accumbens and the most ventral aspects of the pre-commissural caudate and putamen, LST). Additionally, an ROI was drawn on cerebellum as a reference tissue. ROI time activity curves were derived as the average activity in each ROI in each frame. The primary outcome measure was BPND, the binding potential with respect to the non-displaceable compartment, derived by the simplified reference tissue model.|Baseline|47 patients were enrolled and 36 patients were analyzed according to the intent to treat analysis. Only 10 subjects were scanned in this study.|||mCi/ ml||Standard Deviation|Mean
2555219|NCT02744391|Secondary|Pattern Comparison|"This test required participants to identify whether two visual patterns are the same or not the same (responses were made by pressing a yes or no button). Patterns were either identical or varied on one of three dimensions: color (all ages), adding/taking something away (all ages), or one versus many. Scores reflected the number of correct items (of a possible 130) completed in 90 s; items were designed to minimize the number of errors that were made."|Week 3|47 patients were enrolled and 36 patients were analyzed according to the intent to treat analysis.|||total score||Standard Deviation|Mean
2555209|NCT02744391|Secondary|Post-Treatment [11C]-Raclopride Binding Potential: Sensorimotor Striatum|Subjects received 2 [11C]-raclopride positron emission tomography (PET) scans: baseline and post-L-DOPA treatment. High resolution anatomical T1-weighted MRI scans were acquired for each subject and PET data were co-registered to the MRIs using maximization of mutual information (SPM12, Wellcome Centre for Human Neuroimaging). Regions of interest (ROIs) were applied to the MRIs and transferred to the PET data and included the sensorimotor striatum (post-commissural putamen, SMST), associative striatum (whole caudate and pre-commissural putamen, AST) and the limbic striatum (nucleus accumbens and the most ventral aspects of the pre-commissural caudate and putamen, LST). Additionally, an ROI was drawn on cerebellum as a reference tissue. ROI time activity curves were derived as the average activity in each ROI in each frame. The primary outcome measure was BPND, the binding potential with respect to the non-displaceable compartment, derived by the simplified reference tissue model.|Week 3|47 patients were enrolled and 36 patients were analyzed according to the intent to treat analysis. Only 10 subjects were scanned in this study.|||mCi/ ml||Standard Deviation|Mean
2555210|NCT02744391|Secondary|Pre-Treatment [11C]-Raclopride Binding Potential: Sensorimotor Striatum|Subjects received 2 [11C]-raclopride positron emission tomography (PET) scans: baseline and post-L-DOPA treatment. High resolution anatomical T1-weighted MRI scans were acquired for each subject and PET data were co-registered to the MRIs using maximization of mutual information (SPM12, Wellcome Centre for Human Neuroimaging). Regions of interest (ROIs) were applied to the MRIs and transferred to the PET data and included the sensorimotor striatum (post-commissural putamen, SMST), associative striatum (whole caudate and pre-commissural putamen, AST) and the limbic striatum (nucleus accumbens and the most ventral aspects of the pre-commissural caudate and putamen, LST). Additionally, an ROI was drawn on cerebellum as a reference tissue. ROI time activity curves were derived as the average activity in each ROI in each frame. The primary outcome measure was BPND, the binding potential with respect to the non-displaceable compartment, derived by the simplified reference tissue model.|Baseline|47 patients were enrolled and 36 patients were analyzed according to the intent to treat analysis.|||mCi/ ml||Standard Deviation|Mean
2555211|NCT02744391|Secondary|Inventory of Depressive Symptomatology—Self Report|Rating scale for depressive symptoms based on Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria that has been increasingly used in antidepressant studies due to its equivalent weightings for each item, understandable anchor points, and inclusion of all Diagnostic and Statistical Manual of Mental Disorders criteria. Patients will be asked to circle the one response to each item that best describes them for the past seven days. The answers range 0-84. The higher the score the greater the depressive symptoms.|Week 3|47 patients were enrolled and 36 patients were analyzed according to the intent to treat analysis.|||total score||Standard Deviation|Mean
2555212|NCT02744391|Secondary|Inventory of Depressive Symptomatology—Self Report|Rating scale for depressive symptoms based on Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria that has been increasingly used in antidepressant studies due to its equivalent weightings for each item, understandable anchor points, and inclusion of all Diagnostic and Statistical Manual of Mental Disorders criteria. Patients will be asked to circle the one response to each item that best describes them for the past seven days. The answers range 0-84. The higher the score the greater the depressive symptoms.|Screening|47 patients were enrolled and 36 patients were analyzed according to the intent to treat analysis.|||total score||Standard Deviation|Mean
2555213|NCT02744391|Secondary|Dual Task Gait Speed|For the Dual Task, patients are instructed to walk at their usual pace while simultaneously verbally listing as many animals as possible. In addition, a counting Dual Task will be used in which patients are instructed to walk at their usual pace while simultaneously performing serial subtractions by three starting at 100. Patients will start and end at a point 2 meters from the Gaitrite mat to eliminate acceleration and deceleration effects. Dual Task will be assessed two times with the average used in the analyse.|Week 3|47 patients were enrolled and 36 patients were analyzed according to the intent to treat analysis.|||m/s||Standard Deviation|Mean
2555214|NCT02744391|Secondary|Dual Task Gait Speed|For the Dual Task, patients are instructed to walk at their usual pace while simultaneously verbally listing as many animals as possible. In addition, a counting Dual Task will be used in which patients are instructed to walk at their usual pace while simultaneously performing serial subtractions by three starting at 100. Patients will start and end at a point 2 meters from the Gaitrite mat to eliminate acceleration and deceleration effects. Dual Task will be assessed two times with the average used in the analyses|Screening|47 patients were enrolled and 36 patients were analyzed according to the intent to treat analysis.|||m/s||Standard Deviation|Mean
2555215|NCT02744391|Secondary|Single Task Gait Speed|Patients' gait will be assessed as walking speed in m/s on a 15' walking course. Patients are instructed to walk at their usual or normal speed for a total of 27' (starting and ending at a point 6 feet prior to and after the 15' course to eliminate acceleration and deceleration effects). Two trials will be completed, and gait speed will be based on the average of 2 trials.|Week 3|47 patients were enrolled and 36 patients were analyzed according to the intent to treat analysis.|||m/s||Standard Deviation|Mean
2555216|NCT02744391|Secondary|Single Task Gait Speed|Patients' gait will be assessed as walking speed in m/s on a 15' walking course. Patients are instructed to walk at their usual or normal speed for a total of 27' (starting and ending at a point 6 feet prior to and after the 15' course to eliminate acceleration and deceleration effects). Two trials will be completed, and gait speed will be based on the average of 2 trials.|Screening|47 patients were enrolled and 36 patients were analyzed according to the intent to treat analysis.|||m/s||Standard Deviation|Mean
2555217|NCT02744391|Secondary|Letter Comparison|Subjects will be asked to determine whether two strings of letters are the same or different. There are 3 pages and the subject is given 30 seconds per page. Scoring is based on the number answered correctly. The higher the number, the better the score.|Week 3|47 patients were enrolled and 36 patients were analyzed according to the intent to treat analysis.|||Total Correct||Standard Deviation|Mean
2555218|NCT02744391|Secondary|Letter Comparison|Subjects will be asked to determine whether two strings of letters are the same or different. There are 3 pages and the subject is given 30 seconds per page. Scoring is based on the number answered correctly. The higher the number, the better the score.|Screening|47 patients were enrolled and 36 patients were analyzed according to the intent to treat analysis.|||Total Correct||Standard Deviation|Mean
2555220|NCT02744391|Secondary|Pattern Comparison|"This test required participants to identify whether two visual patterns are the same or not the same (responses were made by pressing a yes or no button). Patterns were either identical or varied on one of three dimensions: color (all ages), adding/taking something away (all ages), or one versus many. Scores reflected the number of correct items (of a possible 130) completed in 90 s; items were designed to minimize the number of errors that were made."|Screening|47 patients were enrolled and 36 patients were analyzed according to the intent to treat analysis.|||total score||Standard Deviation|Mean
2555221|NCT02744391|Secondary|Digit Symbol Substitution Test|Digit symbol substitution test (DSST) is a neuropsychological test sensitive to brain damage, dementia, age and depression. The test is not sensitive to the location of brain-damage (except for damage comprising part of the visual field). It consists of (e.g. nine) digit-symbol pairs (e.g. 1/-,2/┴ ... 7/Λ,8/X,9/=) followed by a list of digits. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time (e.g. 90 or 120 sec) is measured. The higher the number, the better the score.|Week 3|47 patients were enrolled and 36 patients were analyzed according to the intent to treat analysis.|||total score||Standard Deviation|Mean
2555222|NCT02744391|Secondary|Digit Symbol Substitution Test|Digit symbol substitution test (DSST) is a neuropsychological test sensitive to brain damage, dementia, age and depression. The test is not sensitive to the location of brain-damage (except for damage comprising part of the visual field). It consists of (e.g. nine) digit-symbol pairs (e.g. 1/-,2/┴ ... 7/Λ,8/X,9/=) followed by a list of digits. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time (e.g. 90 or 120 sec) is measured. The higher the number, the better the score.|Screening|47 patients were enrolled and 36 patients were analyzed according to the intent to treat analysis.|||total score||Standard Deviation|Mean
2555223|NCT02744391|Primary|Hamilton Rating Scale for Depression (24 Item)|Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluate recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score of 16 or above is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.|Week 3|47 patients were enrolled and 36 patients were analyzed according to the intent to treat analysis.|||Units on a Scale||Standard Deviation|Mean
2555224|NCT02744352|Secondary|Range of Motion as Measured by the Disability Assessment of Shoulder and Hand Questionnaire|Dash questionnaire to measure range of motion of the wrist and fingers 3 months after surgery|3 months|Analysis not done because study terminated prior to treatment.||||||
2555225|NCT02744352|Secondary|Number of Subjects With Insomnia as Measured by Sleep Questionnaire|Quality of sleep first 2 nights post surgery|48 hours|Analysis not done because study terminated prior to treatment.||||||
2555226|NCT02744352|Secondary|Quality of Recovery Score|Score of QoR survey to determine recovery status|72 hours|Study was terminated before patient analysis and follow ups were completed.||||||
2555227|NCT02744352|Primary|Participants Need for Pain Relief as Measured by Opiate Consumption|Amount of opiate consumption|72 hours|Analysis not done because study terminated prior to treatment.||||||
2555228|NCT02744352|Primary|Pain Scores as Measured by the Visual Analog Scale|Pain scores at rest and with movement.|72 hours|Analysis not done because study terminated prior to treatment.||||||
2555229|NCT02744066|Secondary|Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff.|A >80% positive response to a multi-question Ease-of-Use Questionnaire completed by the participating NICU staff. Ease-of-Use Questionnaire constructed on a 5 point Likert Scale: 1 = Strongly Disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, 5 = Strongly Agree that the device was easy-to-use. Phase #1 consists of 25 data points. Phase #2 consists of 25 data points. Evaluations were obtained after device removal in both phases.|After 1 hour in phase #1 / After 3 x 8 hours in phase #2||||Participants|||Count of Participants
2555230|NCT02744066|Primary|Number of Participants With Skin Erythema After Device Application|Skin will be assessed for adverse effects such as any device-related adverse events, including evidence of skin redness, rash and/or bruising or discomfort at the site of device application. Skin erythema was described as none, mild, moderate or severe as evaluated by the NICU nursing staff.|Skin erythema was evaluated at the time of device removal after 1 hour of application in phase #1 and after 3 daily 8 hour periods of application in phase #2.|Phase #2 data reports the number of participants experiencing erythema at any time after device removal after 3 daily 8 hour periods of device application.|||Participants|||Count of Participants
2555231|NCT02743962|Other Pre-specified|Subjective Reports of Adverse Events|Participant reports of adverse events will be recorded to inform development of the method|0 to 12 weeks||||Number of adverse events|||Number
2555232|NCT02743962|Secondary|Perceived Ease of Therapeutic Wand Use|"This outcome measure is a single 10 centimetre visual analogue scale rating the participant's perceived ease of using a therapeutic wand. The total achievable in this outcome measure is a score of 100 millimeters and the least achievable is a score of 0. A higher score describes a greater perceived ease of therapeutic wand use. Patients mark along the score line to indicate their perceived ease of therapeutic wand use. The number of millimeters from the 0 point was recorded as their score, for example 57mm. This outcome was recorded at baseline and at 12 weeks for each participant, averaged, and the change in average score was recorded."|0 to 12 weeks||||units on a scale||Standard Deviation|Mean
2555233|NCT02743962|Secondary|Change in Perceived Overall Pain|"This outcome measure is a single 10 centimetre visual analogue scale rating the participant's perceived overall pain. The total achievable in this outcome measure is a score of 100 millimeters and the least achievable is a score of 0. A higher score describes a greater perceived overall pain. Patients mark along the score line to indicate their perceived overall pain. The number of millimeters from the 0 point was recorded as their score, for example 57mm. This outcome was recorded at baseline and at 12 weeks for each participant, averaged, and the change in average score was recorded."|Baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
2555248|NCT02743780|Secondary|Part 1: Terminal Elimination Half-life [t1/2 (h)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was to be collected at each time point.|Pre-dose to 120 hours post-dose|Due to the low exposure and the limit of LLOQ (0.05 ng/mL), none of the observed individual profiles could generate valid t1/2.||||||
2555234|NCT02743962|Secondary|Change in Perceived Urinary Urgency|"This outcome measure is a single 10 centimetre visual analogue scale rating the participant's perceived urinary urgency. The total achievable in this outcome measure is a score of 100 millimeters and the least achievable is a score of 0. A higher score describes a greater perceived urinary urgency. Patients mark along the score line to indicate their perceived urinary urgency. The number of millimeters from the 0 point was recorded as their score, for example 57mm. This outcome was recorded at baseline and at 12 weeks for each participant, averaged, and the change in average score was recorded."|Baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
2555235|NCT02743962|Secondary|Pelvic Pain and Urinary Urgency Frequency Patient Symptom Scale|Single page questionnaire of urinary symptoms, sexual symptoms and perceived bother. This outcome measure has 12 questions, each has between 2 and 4 potential responses which are weighted between 0 and 4 units. The total achievable in this outcome measure is a score of 35 and the least achievable is a score of 0. A higher score describes a worse urinary symptoms, sexual symptoms and a greater burden of the symptoms on the individual. Total scores were collected for analysis at baseline and 12 weeks.|0 to 12 weeks||||units on a scale||Standard Deviation|Mean
2555236|NCT02743962|Secondary|Change in Genitourinary Pain Index|Single page questionnaire of genital pain and rating of perceived bother. This outcome measure has 9 questions, each has between 4 and 10 potential responses which are weighted differently, between 0 and 10 units. The total achievable in this outcome measure is a score of 45 and the least achievable is a score of 0. A higher score describes a higher perceived genital pain level and greater burden of symptoms on the individual. Total scores were collected for analysis.|0 to 12 weeks||||units on a scale||Standard Deviation|Mean
2555237|NCT02743962|Primary|Change in O'Leary-Sant Interstitial Cystitis Problem Index Score|"Single page questionnaire of bladder symptoms and rating of bother. This outcome measure has 4 questions and scores for each question range from 0 to 4. The total achievable in this outcome measure is a score of between 0 to 16. A higher score describes greater burden of Interstitial Cystitis symptoms on the individual.~Total scores were collected for analysis."|Baseline to 6 weeks and 6 to 12 weeks||||units on a scale||Standard Deviation|Mean
2555238|NCT02743962|Primary|Change in O'Leary-Sant Interstitial Cystitis Symptom Index Score|Single page questionnaire of bladder symptoms and rating of bother. This outcome measure has 4 questions and scores for each question range from 0 to 4 or 5. The total achievable in this outcome measure is a score of between 0 to 19. A higher score describes greater symptoms of Interstitial Cystitis. Total scores were collected for analysis.|Baseline to 6 weeks and 6 to 12 weeks||||units on a scale||Standard Deviation|Mean
2555239|NCT02743949|Secondary|Percentage of Participants With ≥1 Sustained Resolution of Heartburn During the 4-Week Treatment Period|≥1 sustained resolution of heartburn is defined as ≥7 consecutive days without both daytime and nighttime heartburn anytime during the 4-week treatment period. Daytime and nighttime heartburn were documented by all participants using the Reflux Symptom Questionnaire Electronic Diary (RESQ-eD).|4 Weeks|The full analysis set (FAS) included all participants randomized to a double-blind study medication.|||percentage of participants|||Number
2555240|NCT02743949|Primary|Percentage of Heartburn-Free 24-Hour Periods (Day and Night) During 4 Weeks of Treatment|Participants used the Reflux Symptom Questionnaire Electronic Diary (RESQ-eD) every morning upon waking and every evening before going to sleep to document the presence of daytime and nighttime heartburn and regurgitation. The percentage of heartburn-free (HBF) 24-hour periods was calculated for each participant using the following formula: (total 24-hour periods that are heartburn free / total 24-hour periods for which both a daytime and nighttime result is marked) x 100%.|4 Weeks|The full analysis set (FAS) included all participants randomized to a double-blind study medication. Data are reported for evaluable participants.|||percentage of HBF 24-hour periods||Standard Deviation|Mean
2555241|NCT02743936|Secondary|Patient Discomfort (Verbal Numerical Rating Scale)|Discomfort scored on a 0-10 verbal numerical rating scale (0 = no discomfort, 10 = most discomfort imaginable)|After study completion (approximately 2 minutes after study start)||||Scores on verbal numerical rating scale||Inter-Quartile Range|Median
2555242|NCT02743936|Primary|Face Mask Leak Measured in Liters Per Minute by the Noninvasive Positive Pressure Ventilation Machine|Face mask leak as measured in liters per minute by the noninvasive positive pressure ventilation machine|2 minutes after mask placement||||Liters per minute||Inter-Quartile Range|Median
2555243|NCT02743780|Secondary|Part 3: Observed Concentration at 12 Hours Following Drug Administration [C12 (ng/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. C12 is reported as mass/volume.|Up to Day 8|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.|||ng/mL||Standard Deviation|Mean
2555244|NCT02743780|Secondary|Part 2: Accumulation Ratio (Racc)|Accumulation Ratio was derived using Cmax on Day 7 versus Cmax on Day 1. Approximately 2 mL of venous blood was collected at each time point.|Day 7|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.|||ng/mL||Standard Deviation|Mean
2555245|NCT02743780|Secondary|Part 2: Area Under the Concentration-time Curve From 0 to the End of the Dosing Interval Tau [AUCtau (ng*h/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. AUCtau is reported as mass*time/volume.|Up to Day 7|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.|||ng*h/mL||Standard Deviation|Mean
2555246|NCT02743780|Secondary|Part 2: Time to Reach Maximum Concentration [Tmax (h)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point.|Up to Day 7|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.|||hours||Full Range|Median
2555247|NCT02743780|Secondary|Part 2: Maximum Observed Concentration [Cmax (ng/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. Cmax is reported as mass/volume.|Up to Day 7|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.|||ng/mL||Standard Deviation|Mean
2555376|NCT02741687|Secondary|Number of Patients Transferred to the ICU Immediately After Surgery or During Hospitalization|The number of patients who were transferred to the ICU immediately following surgery or anytime while hospitalized after surgery.|Up to time of discharge from hospital, an average of 10 days||||Participants|||Count of Participants
2555250|NCT02743780|Secondary|Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to 120 Hours Post Dose [AUC0-120 (ng*h/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was to be collected at each time point.|Pre-dose to 120 hours post-dose|Due to the low exposure and the limit of the lower limit of quantitation (LLOQ) (0.05 ng/mL), none of the observed individual profiles could generate valid AUC0-120.||||||
2555251|NCT02743780|Secondary|Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUClast (ng*h/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. AUClast is reported as mass*time/volume.|Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dose|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.|||ng*h/mL||Standard Deviation|Mean
2555252|NCT02743780|Secondary|Part 1: Time to Reach Maximum Concentration [Tmax (h)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point.|Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dose|PK Analysis Set. Number Analyzed is the number of subjects with data at visit.|||hours||Full Range|Median
2555253|NCT02743780|Secondary|Part 1: Maximum Observed Concentration [Cmax (ng/mL)]|Based on plasma samples collected at pre-determined nominal time points, dependent on observed concentrations. Approximately 2 mL of venous blood was collected at each time point. Cmax is reported as mass/volume.|Pre-dose, .5, 2, 4, 6, 12, 24, 48, 72, 96, 120 hours post-dose, and Day 7 post-dose|This analysis population includes all subjects who received IP, had at least 1 plasma sample following exposure to non-placebo IP and had no known specimen collection or analytical deviations which would affect the integrity of the data (Pharmacokinetic (PK) Analysis Set). Number Analyzed is the number of subjects with data at visit.|||ng/mL||Standard Deviation|Mean
2555254|NCT02743780|Secondary|Part 3: Change From Baseline in IOP at 36 Hours and 48 Hours Post Day 7 Administration|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Baseline IOP was the average of IOP measurements obtained at the 2 eligibility visits. Change from baseline was calculated by taking the change at each time point from baseline to Day 8 and averaging the available changes. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) contributed to the analysis.|Baseline, up to Day 9|Full Analysis Set|||mmHg||Standard Deviation|Mean
2555255|NCT02743780|Primary|Part 3: Change in IOP From Baseline to Day 8 at 8 AM, 10 AM, Noon, 4 PM, and 8 PM|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Baseline IOP was the average of IOP measurements obtained at the 2 eligibility visits. Change from baseline was calculated by taking the change at each time point from baseline to Day 8. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) contributed to the analysis.|Baseline, Day 8|Full Analysis Set|||mmHg||Standard Error|Least Squares Mean
2555256|NCT02743780|Primary|Part 3: Change in Diurnal IOP (Averaged Over 8 AM, 10 AM, Noon, 4 PM, and 8 PM) From Baseline to Day 8|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Diurnal IOP was defined as the average of the five time points measured (8 AM, 10 AM, noon, 4 PM, and 8 PM). Baseline diurnal IOP was the average of IOP measurements obtained at the 2 eligibility visits. Change from baseline was calculated by taking the change at each time point from baseline to Day 8 and averaging the available changes. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) contributed to the analysis.|Baseline, Day 8|Full Analysis Set|||mmHg||Standard Error|Least Squares Mean
2555257|NCT02743702|Primary|Change From Baseline Vital Capacity at One Year.|Change from Baseline vital capacity at one year evaluated by spirometer.|At baseline and at 1 year||||percentage of Change of vital capacity||Inter-Quartile Range|Median
2555258|NCT02743312|Secondary|Number of Falls Recorded in 2 Weeks of Wear Time.|Daily log manually recorded by participant for the 2 weeks of wear time. This is a descriptive measure recording the total count (number) of falls per arm.|count of number of falls recorded at the end of two weeks of wearing TW or SW|total falls in each arm|||falls|||Number
2555259|NCT02743312|Secondary|Electromyography to Assess Muscle Activation|Recording of muscle activation during quiet and perturbed standing before and after intervention at weeks 4, 6, and 8. Average values with and without weighting during each visit.|Week 4, Week 6, Week 8|timing and marker difficulties along with equipment malfunction at some visits resulted in data that could not be analyzed.||||||
2555260|NCT02743312|Secondary|Step Width|As measured using instrumented gait mat.|change from initiation to 2-weeks after initiation of daily wearing of TW or SW||||meters||Standard Deviation|Mean
2555261|NCT02743312|Secondary|Percent of Gait Cycle in Single Limb Support|As measured in percent (e.g., 0.35) of gait cycle spent on one limb using instrumented gait mat.|change from initiation to 2-weeks after initiation of daily wearing of TW or SW||||percentage of gait cycle on one limb||Standard Deviation|Mean
2555262|NCT02743312|Secondary|Stride Length|As measured using instrumented gait mat.|change from initiation to 2-weeks after initiation of daily wearing of TW or SW||||meters||Standard Deviation|Mean
2555263|NCT02743312|Secondary|Six-Minute Walk Test|distance participant walks in 6 minutes. Larger numbers indicate more distance covered. Data reported are the change in distance walked from initiation of TW or SW to after 2 weeks of daily wear.|change from initiation to 2-weeks after initiation of daily wearing of TW or SW||||meters walked||Standard Deviation|Mean
2555264|NCT02743312|Secondary|Multiple Sclerosis Walking Scale 12|Self-report measure of the effect of MS on walking ability. Larger numbers out of 100 mean that MS limits walking much more. Data are reported as change in score from initiation of TW or SW to the visit after 2 weeks of daily wear of TW or SW.|change from initiation to 2-weeks after initiation of daily wearing of TW or SW||||units on a scale||Standard Deviation|Mean
2555265|NCT02743312|Secondary|Multiple Sclerosis Impact Scale 29|Self-report measure of the impact of MS on activities and participation. The scale is reported in a physical and psychological subscale, with higher numbers (out of 100) indicating worse impact of multiple sclerosis (MS) on function. Data are reported as change from initiation of TW or SW to end of 2 weeks of daily wear.|change from initiation to 2-weeks after initiation of daily wearing of TW or SW||||units on a scale||Standard Deviation|Mean
2555266|NCT02743312|Secondary|Activities-Specific Balance Confidence Scale|Self-report measure of perception of confidence under various balance challenges on a scale of 0-100 with 100 being fully confident that the individual can perform the listed balance challenge without falling. Data reported reflect the difference in scores from initiation to the 2-week point after initiation of TW or SW.|change from initiation to 2-weeks after initiation of daily wearing of TW or SW||||units on a scale||Standard Deviation|Mean
2555267|NCT02743312|Secondary|Movement Ability Measure, Computer Adaptive Test Version (MAM-CAT)|Online self-report of perceived current movement ability and preferred movement ability. The scores are reported in standardized logits, 0-6, where 6 is competitive level athletic movement. The reported values are the average change in current movement ability from initiation of daily wear to after 2 weeks of daily wear of TW or SW.|change from initiation to 2-weeks after initiation of daily wearing of TW or SW||||units on a scale||Standard Deviation|Mean
2555268|NCT02743312|Secondary|Gait Velocity|As measured using instrumented gait mat.|change from initiation to 2-weeks after initiation of daily wearing of TW or SW||||meters/second||Standard Deviation|Mean
2555269|NCT02743312|Secondary|Sensory Organization Test|balance tested during 6 conditions on Neuro-com forceplate and surround and reported as a composite score (across the six conditions), 0-100, with higher scores indicating better balance; measure reported reflects change in the composite score from the visit that initiates Torso-weighting (TW) or sham weights (SW) to the visit that concludes daily wearing of TW or SW|change from initiation to 2-weeks after initiation of daily wearing of TW or SW||||scores on a scale||Standard Deviation|Mean
2555270|NCT02743312|Primary|Steps Per Day|Continuous activity data collection via commercially-available remote monitoring device and stored on server.|up to 8 weeks|Server where data were stored failed. No data analyzed for any participant.||||||
2555271|NCT02743221|Secondary|Overall Survival (OS)|The OS was defined as the time from the date of randomisation to the date of death. If death was not confirmed, or patient was alive at study cut-off date, survival time was censored at the date of last follow-up or at the study cut-off date, whichever was earlier.|Baseline up to death or study cut-off (maximum follow-up duration: 19.9 months)|FAS|||months||80% Confidence Interval|Median
2555272|NCT02743221|Secondary|Disease Control Rate (DCR)|DCR was the proportion of patients with confirmed CR, PR or stable disease (SD) as best overall response. SD defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD.|Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)|FAS|||Participants|||Count of Participants
2555273|NCT02743221|Secondary|Duration of Response (DR)|The DR was calculated among patients with CR or PR as the time (months) from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurred first.|Baseline and every 8 weeks (maximum follow-up duration: 16.6 months)|Tumour Response population: patients with measurable disease at baseline and with at least one tumour evaluation while on treatment.|||months||80% Confidence Interval|Median
2555274|NCT02743221|Secondary|Overall Response Rate (ORR)|As per RECIST v1.1, Complete Response (CR) was disappearance of all target lesions; Partial Response (PR) was at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The ORR was the proportion of patients who presented CR or PR with confirmation at subsequent time point or at least 4 weeks later.|Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)|FAS|||Participants|||Count of Participants
2555275|NCT02743221|Primary|Progression Free Survival (PFS)|The progression free survival (PFS), defined as the time from the date of randomisation until the date of the investigator-assessed radiological disease progression or death due to any cause according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive disease (PD) was defined at least a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) and an absolute increase of at least 5 mm in the sum of lesions or the appearance of new lesions.|Baseline and every 8 weeks (maximum follow-up duration: 17.9 months)|Full Analysis Set (FAS): all randomised patients who have taken at least one dose of study treatment.|||months||95% Confidence Interval|Median
2555276|NCT02743117|Secondary|Percentage of Participants Who Require Antipyretic and/or Analgesic Medication|Percentage of participants who require antipyretic and/or analgesic medication were reported.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.|||Percentage of participants|||Number
2555277|NCT02743117|Secondary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs were serious events between administration of study drug and up to 181 days after the dose that are absent before treatment or that worsen relative to pretreatment state. An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. Results were given for TESAEs and NOCDs reported up to 29 days and 181 days after vaccination.|Baseline (Day 1) up to Day 29 and Day 181|The ITT population included all participants that were randomized and treated with investigational product.|||Participants|||Number
2555278|NCT02743117|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were events between administration of study drug and up to 15 days after vaccination that are absent before treatment or that worsened relative to pre-treatment state. Results were given for AEs reported up to 8 days and 15 days after vaccination.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.|||Participants|||Number
2555298|NCT02742766|Secondary|Part 3: Tmax of GSK3008356 on Day 1 and Day 28|Part 3 was planned as a 28-day, repeat dose study in obese participants; however, since a tolerable dose with sufficient pharmacodynamic effects was not identified, this portion of the study was not conducted.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8 (only in cohort 1), 12, 14 (only in cohorts 2 and 3), 18, and 24 hours post-dose on Day 1 and Day 28 and additionally 36, 48, and 72 hours post-dose on Day 28|PK Parameter Population.||||||
2555279|NCT02743117|Secondary|Percentage of Participants With Solicited Symptoms|Solicited symptoms are predefined symptoms or events specifically inquired about and assessed daily after vaccine administration up to 15 days after vaccination. The solicited symptoms include fever greater than (>) 100.0 degrees F (37.8 degrees Celsius), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity and headache. Results were reported for all solicited symptoms except fever >=101 degrees F (reported as primary outcome) up to 8 days after vaccination and all solicited symptoms up to 15 days after vaccination.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.|||Percentage of participants|||Number
2555280|NCT02743117|Primary|Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)|Percentage of participants with fever defined as oral temperature >=101 degrees F were reported.|Baseline (Day 1) up to Day 8|The intent-to-treat (ITT) population included all participants that were randomized and treated with investigational product.|||Percentage of participants|||Number
2555281|NCT02742987|Secondary|Number of Patients With Platelet Reactivity >256 P2Y12 Reaction Units||4 weeks|||||||
2555282|NCT02742987|Secondary|Platelet Reactivity|Platelet reactivity assessed with the VerifyNow P2Y12 Assay|4 weeks|||||||
2555283|NCT02742987|Secondary|Endothelium-independent Dilation of the Brachial Artery|Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-administration of 0.5 mg sublingual nitroglycerin|4 weeks|||||||
2555284|NCT02742987|Secondary|Number of Patients With Flow-mediated Dilation of the Brachial Artery <7%||4 weeks|||||||
2555285|NCT02742987|Primary|Flow-mediated Dilation of the Brachial Artery|Percent dilation of the brachial artery, as assessed with vascular ultrasound, from baseline to post-occlusion|4 weeks||||FMD (%)||Standard Deviation|Mean
2555286|NCT02742818|Secondary|Duration of Surgery ( in Minutes)|The investigators will observe the duration of surgery (in minutes) in the two groups studied.|Across duration of surgery ( in minutes)|Models of generalized estimation equations will be used to evaluate the evolution of body temperature across duration of surgery (in minutes)|||minutes||Inter-Quartile Range|Median
2555287|NCT02742818|Secondary|Type of Surgery ( LEA and EVAR )|The investigators will observe the type of surgery distribution profile in the two groups studied.|At time of surgery ( in minutes)||||Participants|||Count of Participants
2555288|NCT02742818|Secondary|Gender|The investigators will observe gender distribution in the two groups studied.|At time of surgery ( in minutes)||||Participants|||Count of Participants
2555289|NCT02742818|Secondary|Age ( in Years)|The investigators will observe the profile of the patients and the mean of age in two groups.|At time of surgery ( in minutes)||||years||Inter-Quartile Range|Median
2555290|NCT02742818|Primary|Values of Body Temperature ( in Celsius Degree ) in Two Groups of Patients Undergoing EVAR and LEA That Will Use Two Different Types of Bair Hugger 3M Body Warming Blankets, Namely: 522 Upper Body Blanket and 635 Full Access Underbody Blanket.|After tracheal intubation, upper body or underbody blanket will be turned on at the highest temperature of the warming unit ( 43 celsius degree) and the body temperatures will be measured and registered with an esophageal thermometer every 15 minutes until tracheal extubation. Temperatures will be compared with the purposes of determining which one of the two models tested are more effective in keeping patient warm. Values of body temperature across duration of surgery will be compared by models of variance analysis with repeated measurements. Duration of surgery will be used as a control variable.|Across duration of surgery (up to 210 minutes)|In the Underbody blanket group 2 patients were excluded from analysis. One of the patients due to anaphylactic reaction and the other framed exclusion criteria (Surgery time lesser than 45 minutes)|||Celsius degrees||Full Range|Median
2555291|NCT02742766|Secondary|Part 3: Postprandial Triglyceride Levels Following 28-day Repeat Dosing of GSK3008356 in Obese Participants|Part 3 was planned as a 28-day, repeat dose study in obese participants; however, since a tolerable dose with sufficient pharmacodynamic effects was not identified, this portion of the study was not conducted.|Day -1, Day 1, and Day 28 in cohort 1, and Day 1, Day 2, and Day 28 in cohorts 2 and 3|PD Population.||||||
2555292|NCT02742766|Secondary|Part 3: Ctrough to Assess Steady State of GSK3008356 Following 28-day Repeat Dosing|Part 3 was planned as a 28-day, repeat dose study in obese participants; however, since a tolerable dose with sufficient pharmacodynamic effects was not identified, this portion of the study was not conducted.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8 (only in cohort 1), 12, 14 (only in cohorts 2 and 3), 18, and 24 hours post-dose on Days 1 and 28 and additionally 36, 48, and 72 hours post-dose on Day 28|PK Parameter Population.||||||
2555293|NCT02742766|Secondary|Part 3: Observed Accumulation Ratio of GSK3008356|Part 3 was planned as a 28-day, repeat dose study in obese participants; however, since a tolerable dose with sufficient pharmacodynamic effects was not identified, this portion of the study was not conducted.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8 (only in cohort 1), 12, 14 (only in cohorts 2 and 3), 18, and 24 hours post-dose on Days 1 and 28 and additionally 36, 48, and 72 hours post-dose on Day 28|PK Parameter Population.||||||
2555294|NCT02742766|Secondary|Part 3: Dose Proportionality of GSK3008356|Part 3 was planned as a 28-day, repeat dose study in obese participants; however, since a tolerable dose with sufficient pharmacodynamic effects was not identified, this portion of the study was not conducted.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8 (only in cohort 1), 12, 14 (only in cohorts 2 and 3), 18, and 24 hours post-dose on Days 1 and 28 and additionally 36, 48, and 72 hours post-dose on Day 28|PK Parameter Population.||||||
2555295|NCT02742766|Secondary|Part 3: CLr of GSK3008356 on Day 28|Part 3 was planned as a 28-day, repeat dose study in obese participants; however, since a tolerable dose with sufficient pharmacodynamic effects was not identified, this portion of the study was not conducted.|Day 28 in each cohort|PK Parameter Population.||||||
2555296|NCT02742766|Secondary|Part 3: Ae of GSK3008356 on Day 28|Part 3 was planned as a 28-day, repeat dose study in obese participants; however, since a tolerable dose with sufficient pharmacodynamic effects was not identified, this portion of the study was not conducted.|Day 28 in each cohort|PK Parameter Population.||||||
2555297|NCT02742766|Secondary|Part 3: t1/2 of GSK3008356 on Day 28|Part 3 was planned as a 28-day, repeat dose study in obese participants; however, since a tolerable dose with sufficient pharmacodynamic effects was not identified, this portion of the study was not conducted.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8 (only in cohort 1), 12, 14 (only in cohorts 2 and 3), 18, 24, 36, 48, and 72 hours post-dose on Day 28|PK Parameter Population.||||||
2555299|NCT02742766|Secondary|Part 3: Cmax of GSK3008356 on Day 1 and Day 28|Part 3 was planned as a 28-day, repeat dose study in obese participants; however, since a tolerable dose with sufficient pharmacodynamic effects was not identified, this portion of the study was not conducted.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8 (only in cohort 1), 12, 14 (only in cohorts 2 and 3), 18, and 24 hours post-dose on Day 1 and Day 28 and additionally 36, 48, and 72 hours post-dose on Day 28|PK Parameter Population.||||||
2555300|NCT02742766|Secondary|Part 3: AUC (0-tau) of GSK3008356 on Day 1 and Day 28|Part 3 was planned as a 28-day, repeat dose study in obese participants; however, since a tolerable dose with sufficient pharmacodynamic effects was not identified, this portion of the study was not conducted.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8 (only in cohort 1), 12, 14 (only in cohorts 2 and 3), 18, and 24 hours post-dose on Day 1 and Day 28 and additionally 36, 48, and 72 hours post-dose on Day 28|PK Parameter Population.||||||
2555301|NCT02742766|Secondary|Part 2: Postprandial Triglyceride Levels Following 14-day Repeat Dosing of GSK3008356|Preliminary pharmacodynamics of GSK3008356 was evaluated by assessing the postprandial triglyceride levels at the indicated time points. Corrected TG value (Day 1 and Day 14) at each nominal sampling time point defined as the corresponding post dose value by adding the following value: Part 2 Day 1 Correction: (Day -1 (1 hour + 2 hour)/2) - (Day 1 (1 hour + 2 hour)/2); Part 2 Day 14 Correction: (Day -1 (1 hour + 2 hour)/2) - (Day 14 (1 hour + 2 hour)/2). Mean triglyceride levels are presented.|Day 1 (1, 2, 3, 4, 5, 6, 7, 8, 9 and 12 hours post-dose) and Day 14 (1, 2, 3, 4, 5, 6, 7, 8, 9 and 12 hours post-dose)|PD Population. Only those participants available at the specified time points were analyzed.|||Millimoles/Liter||Standard Deviation|Mean
2555302|NCT02742766|Secondary|Part 2: Trough Plasma Concentrations (Ctrough) to Assess Steady State of GSK3008356 Following 14-day Repeat Dosing|Ctrough is the observed concentration at the end of a dosing interval, immediately before next administration. Due to the cancellation of Part 2, Cohort B1, there are no PK parameters available on Day 14 for that dose.|Pre-dose on Days 2, 4, 5, 6, 12, 13, 14 and the 24 hours post-dose on Day 14|PK Parameter Population. Only those participants available at the specified time points were analyzed.|||Nanograms/Milliliters||Standard Deviation|Mean
2555303|NCT02742766|Secondary|Part 2: Observed Accumulation Ratio of GSK3008356|Observed accumulation ratio based on AUC(0- tau) is (Ro), and based on Cmax is (RCmax). Ro was calculated as the ratio [AUC0-tau on the final day (Day 14)]/[ AUC0-tau on Day 1] and Rcmax was calculated as the ratio [Cmax on the final day (Day 14)]/[Cmax on Day 1]. Blood samples for PK analysis of GSK3008356 were collected at the indicated time points.|Day 1 pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18 and 24 hours post-dose, pre-dose Day 4, 5, 6, 12 and 13 and Day 14 pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18 and 24, 36, 48 and 72 hours post dose|PK Parameter Population. Only those participants available at the specified time points were analyzed.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2555304|NCT02742766|Secondary|Part 2: Dose Proportionality of GSK3008356 for Dose 1 mg BID vs 10 mg BID and 3 mg BID After Repeat Dose Administration Based on Cmax|The dose proportionality was assessed using a power model on logarithmic transformation of Cmax, with the logarithmic transformation of dose as the single covariate in the linear regression. Due to the cancellation of Part 2, Cohort B1, there are no PK parameters available on Day 14 for that dose. Point estimates and 90% confidence interval are presented for Day 1 and Day 14 of Part 2.|Day 1 pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18 and 24 hours post-dose, pre-dose Day 4, 5, 6, 12 and 13 and Day 14 pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18 and 24, 36, 48 and 72 hours post-dose|PK Parameter Population.|||Slope of log dose||90% Confidence Interval|Number
2555305|NCT02742766|Secondary|Part 2: Dose Proportionality of GSK3008356 for Dose 1 mg BID vs 10 mg BID and 3 mg BID After Repeat Dose Administration Based on AUC|Dose proportionality was assessed from Day 1 and Day 14 AUC (0 to tau) obtained from multiple cohorts in Part 2. The dose proportionality was assessed using a power model on logarithmic transformation of AUC, with the logarithmic transformation of dose as the single covariate in the linear regression. Due to the cancellation of Part 2, Cohort B1, there are no PK parameters available on Day 14 for that dose. Point estimates and 90% confidence interval are presented.|Day 1 pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18 and 24 hours post-dose, pre-dose Day 4, 5, 6, 12 and 13 and Day 14 pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18 and 24, 36, 48 and 72 hours post dose|PK Parameter Population. Only those parameters available at the specified time points were analyzed.|||Slope of log dose||90% Confidence Interval|Number
2555306|NCT02742766|Secondary|Part 2: CLr of GSK3008356 on Day 14|Urine samples (urine concentrations or volumes) were not collected for the Part 2 of the study.|Pre-dose and 24 hours post-dose on Day 14|PK Parameter Population.||||||
2555307|NCT02742766|Secondary|Part 2: Ae of GSK3008356 on Day 14|Urine samples (urine concentrations or volumes) were not collected for the Part 2 of the study.|Pre-dose and 24 hours post-dose on Day 14|PK Parameter Population.||||||
2555308|NCT02742766|Secondary|Part 2: t1/2 and Tmax of GSK3008356 on Day 1 and Day 14|Blood samples for PK analysis of GSK3008356 were collected at the indicated time points. Due to the cancellation of Part 2, Cohort B1, there are no PK parameters available on Day 14 for that dose.|Day 1 pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18 and 24 hours post-dose, pre-dose Day 4, 5, 6, 12 and 13 and Day 14 pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18 and 24, 36, 48 and 72 hours post dose|PK Parameter Population. Only those participants available at the specified time points were analyzed.|||Hours||Standard Deviation|Mean
2555309|NCT02742766|Secondary|Part 2: Cmax of GSK3008356 on Day 1 and Day 14|Blood samples for PK analysis of GSK3008356 were collected at the indicated time points. Due to the cancellation of Part 2, Cohort B1, there are no PK parameters available on Day 14 for that dose.|Day 1 pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18 and 24 hours post-dose, pre-dose Day 4, 5, 6, 12 and 13 and Day 14 pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18 and 24, 36, 48 and 72 hours post dose|PK Parameter Population. Only those participants available at the specified time points were analyzed.|||Nanograms/milliliters||Geometric Coefficient of Variation|Geometric Mean
2555323|NCT02742766|Primary|Part 3: Number of Participants With Vital Signs of Potential Clinical Concern|Part 3 was planned as a 28-day, repeat dose study in obese participants; however, since a tolerable dose with sufficient pharmacodynamic effects was not identified, this portion of the study was not conducted.|Up to Day 36|Safety Population.||||||
2555380|NCT02741687|Secondary|Number of Patients Requiring Supplemental, Subcutaneous Insulin|Number of patients requiring subcutaneous insulin, either sliding scale insulin or basal insulin|Up to time of discharge from hospital, an average of 10 days||||Participants|||Count of Participants
2555310|NCT02742766|Secondary|Part 2: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the End of Dosing Interval (AUC[0 to Tau]) of GSK3008356 on Day 1 and Day 14|Blood samples for PK analysis of GSK3008356 were collected at the indicated time points. Due to the cancellation of Part 2, Cohort B1, there are no PK parameters available on Day 14 for that dose.|Day 1 pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18 and 24 hours post-dose, pre-dose Day 4, 5, 6, 12 and 13 and Day 14 pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18 and 24, 36, 48 and 72 hours post dose|PK Parameter Population. Only those participants available at the specified time points were analyzed.|||Hours*nanograms/milliliters||Geometric Coefficient of Variation|Geometric Mean
2555311|NCT02742766|Secondary|Part 1: Postprandial Triglyceride Levels Following a Single Dose and Multiple Doses of GSK3008356|Preliminary pharmacodynamics of GSK3008356 was evaluated by assessing the postprandial triglyceride levels at the indicated time points. Corrected triglyceride value (Day 1) at each nominal sampling time point was defined as the corresponding post dose value by adding the following value: Part 1 Day 1 Correction: (Day -1 (1 hour + 2 hour)/2) - (Day 1 (1 hour + 2 hour)/2). Mean triglyceride levels are presented.|Day 1 at 1,2,3,4,5,6,7,8,9,12 hours post-dose|Pharmacodynamic (PD) Population comprised of participants in the Safety population for whom at least one postprandial triglyceride sample was obtained and analyzed at Baseline and post Baseline. Only those participants available at the specified time points were analyzed.|||Millimoles/Liters||Standard Deviation|Mean
2555312|NCT02742766|Secondary|Part 1: Dose Proportionality of GSK3008356 for Dose 5 mg vs. 200 mg After Single Dose Administration Based on Cmax|Dose proportionality was assessed from the Cmax obtained from multiple cohorts in Part 1. The dose proportionality was assessed using a power model on logarithmic transformation of Cmax, with the logarithmic transformation of dose as the single covariate in the linear regression. For Cmax, only a single dose group from Cohort 1 to Cohort 6 was considered since other cohorts are multiple dosing where Cmax is so different from that of single dose group. Data for Cohort A5 vs. Cohort A1 is presented, Point estimates and 90% confidence interval are presented.|Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18, 24 hours post-dose on Day 1 and 36, 48, and 72 hours post-dose|PK Parameter Population. Only those participants available at the specified time points were analyzed.|||Slope of log dose||90% Confidence Interval|Number
2555313|NCT02742766|Secondary|Part 1: Dose Proportionality of GSK3008356 for Dose 5 mg Versus (vs.) 200 mg After Single Dose Administration and Multiple Dose Administration (100 mg t0, t4 and 100 mg t0, t16) Based on AUC|Dose proportionality was assessed from the AUC (0 to t) and AUC (0 to inf) obtained from multiple cohorts in Part 1. The dose proportionality was assessed using a power model on logarithmic transformation of AUC with the logarithmic transformation of dose as the single covariate in the linear regression. Point estimates and 90% confidence interval are presented.|Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18, 24 hours post-dose on Day 1 and 36, 48, and 72 hours post-dose|PK Parameter Population.|||Slope of log dose||90% Confidence Interval|Number
2555314|NCT02742766|Secondary|Part 1: Renal Clearance of Drug From Plasma (CLr) of GSK3008356|Urine samples for PK analysis of GSK3008356 were collected at the indicated time points.|Pre-dose and over the post-dose intervals 0 to 12 hours and 12 to 24 hours|PK Parameter Population. Only those participants available at the specified time points were analyzed.|||Milliliters per hour||Standard Deviation|Mean
2555315|NCT02742766|Secondary|Part 1: Cumulative Amount of Unchanged Drug Excreted Into the Urine (Ae) of GSK3008356|Urine samples for PK analysis of GSK3008356 were collected at the indicated time points.|Pre-dose and over the post-dose intervals 0 to 12 hours and 12 to 24 hours|PK Parameter Population.|||Nanograms*10^5||Standard Deviation|Mean
2555316|NCT02742766|Secondary|Part 1: Time to Maximum Observed Plasma Concentration (Tmax) of GSK3008356 and Apparent Terminal Half-life (t1/2) of GSK3008356|Blood samples for PK analysis of GSK3008356 were collected at the indicated time points.|Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18, 24 hours post dose on Day 1 and 36, 48, and 72 hours post-dose|PK Parameter Population.|||Hours||Standard Deviation|Mean
2555317|NCT02742766|Secondary|Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK3008356|Blood samples for PK analysis of GSK3008356 were collected at the indicated time points.|Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18, 24 hours post dose on Day 1 and 36, 48, and 72 hours post-dose|PK Parameter Population.|||Nanograms per milliliters||Geometric Coefficient of Variation|Geometric Mean
2555318|NCT02742766|Secondary|Part 1: Area Under the Concentration-time Curve (AUC) Extrapolated to Infinity (AUC[0 to Inf]), AUC From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0 to t]) and AUC From Time Zero to 24 Hour (AUC[0 to 24])|Blood samples for pharmacokinetic (PK) analysis of GSK3008356 were collected at the indicated time points.|Pre-dose, and 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 18, 24 hours post-dose on Day 1 and 36, 48, and 72 hours post-dose|PK Parameter Population comprised of all participants in the PK Concentration Population (participants for whom a PK sample was obtained and analyzed) who received at least one active dose of GSK3008356 and provided PK parameters. Only those participants available at the specified time points were analyzed.|||Hours*nanograms/milliliters||Geometric Coefficient of Variation|Geometric Mean
2555319|NCT02742766|Primary|Part 3: Number of Participants With AE and SAE|Part 3 was planned as a 28-day, repeat dose study in obese participants; however, since a tolerable dose with sufficient pharmacodynamic effects was not identified, this portion of the study was not conducted.|Up to Day 36|Safety Population.||||||
2555320|NCT02742766|Primary|Part 3: Number of Participants With Laboratory Values of Potential Clinical Concern|Part 3 was planned as a 28-day, repeat dose study in obese participants; however, since a tolerable dose with sufficient pharmacodynamic effects was not identified, this portion of the study was not conducted.|Up to Day 36|Safety Population.||||||
2555321|NCT02742766|Primary|Part 3: Number of Participants With Clinically Significant Findings During Cardiac Monitoring|Part 3 was planned as a 28-day, repeat dose study in obese participants; however, since a tolerable dose with sufficient pharmacodynamic effects was not identified, this portion of the study was not conducted.|Day 1 (Pre-dose to 4 hours post-dose)|Safety Population.||||||
2555322|NCT02742766|Primary|Part 3: Number of Participants With 12-lead ECG Values of Potential Clinical Concern|Part 3 was planned as a 28-day, repeat dose study in obese participants; however, since a tolerable dose with sufficient pharmacodynamic effects was not identified, this portion of the study was not conducted.|Up to Day 31|Safety Population.||||||
2555492|NCT02739984|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
2555325|NCT02742766|Primary|Part 2: Number of Participants With AE and SAE|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or is associated with liver injury and impaired liver function.|Up to Day 22|Safety Population.|||Participants|||Number
2555326|NCT02742766|Primary|Part 2: Number of Participants With Laboratory Values of Potential Clinical Concern|Hematology parameters included hematocrit, hemoglobin, platelets, white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells and reticulocytes. Clinical chemistry parameters included blood urea nitrogen, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, uric acid, total protein, total and direct bilirubin, albumin, calcium, bile acids, chloride, creatinine, glucose (fasting/non-fasting), potassium, sodium and total carbon dioxide/bicarbonate. Urinalysis included specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick and microscopic examination (within 120 minutes of collection).|Up to Day 22|Safety Population.|||Participants|||Number
2555327|NCT02742766|Primary|Part 2: Number of Participants With Clinically Significant Findings During Cardiac Monitoring|Continuous lead II cardiac telemetry or cardiac monitoring was performed on Day 1. Number of participants with clinically significant findings during cardiac monitoring in Part 2 are presented.|Day 1 (Pre-dose to 4 hours post dose)|Safety Population.|||Participants|||Number
2555328|NCT02742766|Primary|Part 2: Number of Participants With 12-lead ECG Values of Potential Clinical Concern|Single 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals, and QTcF. Number of participants with 12-lead ECG values of potential clinical concern in Part 2 are presented.|Up to Day 17|Safety Population.|||Participants|||Number
2555329|NCT02742766|Primary|Part 2: Number of Participants With Vital Signs of Potential Clinical Concern|Vital signs included systolic and diastolic blood pressure and pulse and was measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring.|Up to Day 22|Safety Population.|||Participants|||Number
2555330|NCT02742766|Primary|Part 2: Number of Participants With Abnormal Findings in Physical Examination|A complete physical examination included assessment of the cardiovascular, respiratory, gastrointestinal, dermatologic and neurological systems, height, and weight. Height was measured and recorded only at screening. A brief physical examination included assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). Weight was recorded with the brief physical exam, but was not part of the brief physical exam. Number of participants with abnormal findings in physical examinations in Part 2 are presented.|Up to Day 22|Safety Population.|||Participants|||Number
2555331|NCT02742766|Primary|Part 1: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or is associated with liver injury and impaired liver function.|Up to Day 8|Safety Population.|||Participants|||Number
2555332|NCT02742766|Primary|Part 1: Number of Participants With Laboratory Values of Potential Clinical Concern|Hematology parameters included hematocrit, hemoglobin, platelets, white blood cells (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells (RBC) and reticulocytes. Clinical chemistry parameters included blood urea nitrogen, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, uric acid, total protein, total and direct bilirubin, albumin, calcium, bile acids, chloride, creatinine, glucose (fasting/non-fasting), potassium, sodium and total carbon dioxide/bicarbonate. Urinalysis included specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick and microscopic examination of urine (WBC, RBC and casts) within 120 minutes of collection.|Up to Day 8|Safety Population.|||Participants|||Number
2555333|NCT02742766|Primary|Part 1: Number of Participants With Clinically Significant Findings During Cardiac Monitoring|Continuous lead II cardiac telemetry or cardiac monitoring was performed on Day 1. Number of participants with clinically significant findings during cardiac monitoring in Part 1 are presented.|Day 1|Safety Population.|||Participants|||Number
2555334|NCT02742766|Primary|Part 1: Number of Participants With 12-lead Electrocardiogram (ECG) Values of Potential Clinical Concern|Single 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, and QT intervals, and QT interval corrected by Fridericia's formula (QTcF). Number of participants with 12-lead ECG values of potential clinical concern in Part 1 are presented.|Up to Day 4|Safety Population.|||Participants|||Number
2555335|NCT02742766|Primary|Part 1: Number of Participants With Vital Signs of Potential Clinical Concern|Vital signs included systolic and diastolic blood pressure and pulse rate and were measured with the participant in semi-supine position after 5 minutes rest. Temperature was also measured as a vital sign but did not require positioning or rest prior to measuring.|Up to Day 8|Safety Population.|||Participants|||Number
2555377|NCT02741687|Secondary|Number of Participants With Hypoglycemic Events|Number of participants experiencing at least one episode of mild hypoglycemia (blood glucose < 70 mg/dL) or clinically significant hypoglycemia (blood glucose < 54 mg/dL)|Up to time of discharge from hospital, an average of 10 days||||Participants|||Count of Participants
2555336|NCT02742766|Primary|Part 1: Number of Participants With Abnormal Findings in Physical Examinations|A complete physical examination included assessment of the cardiovascular, respiratory, gastrointestinal, dermatologic and neurological systems, height, and weight. Height was measured and recorded only at screening. A brief physical examination included assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). Weight was recorded with the brief physical exam, but was not part of the brief physical exam. Number of participants with abnormal findings in physical examinations in Part 1 are presented.|Up to Day 8|Safety Population comprised of all participants who received at least one dose of study medication.|||Participants|||Number
2555337|NCT02742649|Secondary|IOP During Open Label Period|IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour) at the start (Day 98) and end (Day 112) of the Open Label Period during which participants were treated with timolol 0.5% ophthalmic solution twice daily. The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.|Day 98, Day 112|FAS included all participants who were randomized, treated and returned for at least one (1) regularly scheduled post-treatment visit. Participants were analyzed in the treatment group to which they were randomized (Double Blind Treatment Period). Number analyzed is the number of participants with data at the given time-point.|||mm Hg||Standard Deviation|Mean
2555338|NCT02742649|Secondary|Number of Participants With Ocular and Non-Ocular Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Reported here is the number of participants with adverse events related to the eye as well as number of participants with all other adverse events.|From Randomization (Day 0) to Day 70|Safety population set included all randomized participants who had an ocular insert placed at the Randomization Visit. In this analysis set, participants were analyzed according to the treatment received during each study treatment period.|||Participants|||Count of Participants
2555339|NCT02742649|Primary|IOP on Day 70|IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.|Day 70|FAS included all participants who were randomized, treated and returned for at least one (1) regularly scheduled post-treatment visit. Participants were analyzed in the treatment group to which they were randomized (Double Blind Treatment Period). Number analyzed is the number of participants with data at the given time-point.|||mm Hg||Standard Deviation|Mean
2555340|NCT02742649|Primary|IOP on Day 49|IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.|Day 49|FAS included all participants who were randomized, treated and returned for at least one (1) regularly scheduled post-treatment visit. Participants were analyzed in the treatment group to which they were randomized (Double Blind Treatment Period). Number analyzed is the number of participants with data at the given time-point.|||mm Hg||Standard Deviation|Mean
2555341|NCT02742649|Primary|IOP on Day 28|IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.|Day 28|FAS included all participants who were randomized, treated and returned for at least one (1) regularly scheduled post-treatment visit. Participants were analyzed in the treatment group to which they were randomized (Double Blind Treatment Period). Number analyzed is the number of participants with data at the given time-point.|||mm Hg||Standard Deviation|Mean
2555342|NCT02742649|Primary|IOP on Day 16|IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.|Day 16|FAS included all participants who were randomized, treated and returned for at least one (1) regularly scheduled post-treatment visit. Participants were analyzed in the treatment group to which they were randomized (Double Blind Treatment Period). Number analyzed is the number of participants with data at the given time-point.|||mm Hg||Standard Deviation|Mean
2555343|NCT02742649|Primary|Intraocular Pressure (IOP) on Day 8|IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.|Day 8|FAS included all participants who were randomized, treated and returned for at least one (1) regularly scheduled post-treatment visit. Participants were analyzed in the treatment group to which they were randomized (Double Blind Treatment Period).|||mm Hg||Standard Deviation|Mean
2555344|NCT02742519|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)||Baseline up to Month 15|The Safety Set was used which included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2555345|NCT02742519|Secondary|Absolute Change From Baseline in Body Mass Index (BMI) at Week 8|BMI was defined as weight in kilogram (kg) divided by height in square meter (m^2).|Baseline and Week 8 of each treatment period, Up to 24 Weeks|FAS was used which included all randomized participants who had mutation on at least 1 allele, received at least 1 dose of study drug (Ivacaftor or placebo) and had at least 1 post-baseline assessment.|||Kilogram per meter square (kg/m^2)||Standard Deviation|Mean
2555346|NCT02742519|Secondary|Absolute Change From Baseline in Weight at Week 8||Baseline and Week 8 of each treatment period, Up to 24 Weeks|FAS was used which included all randomized participants who had mutation on at least 1 allele, received at least 1 dose of study drug (Ivacaftor or placebo) and had at least 1 post-baseline assessment.|||Kilogram (kg)||Standard Deviation|Mean
2555378|NCT02741687|Secondary|Length of Hospital Stay|Total length of hospital stay|Up to time of discharge from hospital, an average of 10 days||||days||Inter-Quartile Range|Median
2555347|NCT02742519|Secondary|Absolute Change From Baseline in Fecal Elastase-1 Levels at Week 8|Fecal elastase-1 was used clinically to diagnose pancreatic exocrine insufficiency in participants with cystic fibrosis.|Baseline and Week 8 of each treatment period, Up to 24 Weeks|"FAS was used which included all randomized participants who had mutation on at least 1 allele, received at least 1 dose of study drug (Ivacaftor or placebo) and had at least 1 post-baseline assessment. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome measure."|||microgram per gram (mcg/g)||Standard Deviation|Mean
2555348|NCT02742519|Secondary|Absolute Change From Baseline in Immunoreactive Trypsinogen Levels at Week 8|Serum samples were collected for evaluation of change in immunoreactive trypsinogen levels at Week 8.|Baseline and Week 8 of each treatment period, Up to 24 Weeks|"FAS was used which included all randomized participants who had mutation on at least 1 allele, received at least 1 dose of study drug (Ivacaftor or placebo) and had at least 1 post-baseline assessment. Here Overall Number of Participants Analyzed signifies those participants who were evaluated for this outcome measure."|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2555349|NCT02742519|Primary|Absolute Change From Baseline in Lung Clearance Index (LCI2.5) Through 8 Weeks of Treatment (Average of Week 4 and Week 8 LCI2.5)|LCI2.5 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting value.|Baseline Through Week 8 for each treatment period, Up to 24 Weeks|Full Analysis Set (FAS) was used which included all randomized participants who had mutation on at least 1 allele, received at least 1 dose of study drug (Ivacaftor or placebo) and had at least 1 post-baseline assessment.|||Lung clearance index||Standard Deviation|Mean
2555350|NCT02742441|Other Pre-specified|Changes in Percent BSA With Active Psoriasis in the Treatment Area|The percent (%) Body Surface Area (BSA) with active psoriasis in the Treatment Area will be determined at the Baseline Visit and Week 2 (Day 15) and documented. At Baseline, the percent BSA with active psoriasis in the Treatment Area must be 2% to 12%, inclusive.|Day 15|Analysis shown is based on the ITT population. Only participants with observed values are reported. The mean percent BSA with active psoriasis at Baseline was 5.4% and 5.1% for the active and vehicle groups, respectively.|||Change in percent BSA||Standard Deviation|Mean
2555351|NCT02742441|Other Pre-specified|Change From Baseline in Pruritus Score|At the Baseline Visit, prior to the first application of the test article, the subject's overall experience of pruritus within the previous two (2) weeks will be assessed and scored (range 1-5) using a questionnaire that assesses the degree, duration, direction, disability, and distribution of the subject's pruritus. Possible total scores range from 5 (no pruritus) to 25 (most severe pruritus). At Day 15, the overall experience of pruritus, in the previous two weeks, will be scored using the same questionnaire.|Day 15|Analysis shown is based on the ITT population. Only participants with observed values are reported. Pruritus scores were based on the patient’s assessment of pruritus ranging from a score of 5 (no pruritus) to 25 (most severe pruritus).|||scores on a scale||Standard Deviation|Mean
2555352|NCT02742441|Other Pre-specified|"Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)"||Day 8|Analysis shown is based on the ITT population. Only participants with observed values are reported.|||percentage of participants|||Number
2555353|NCT02742441|Other Pre-specified|"Percentage of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA)"||Day 8|Analysis shown is based on the ITT population. Only participants with observed values are reported.|||percentage of participants|||Number
2555354|NCT02742441|Secondary|"Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)"|"Scaling, erythema and plaque elevation will each be scored on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. These evaluations are an assessment of the overall or average degree of each of three key characteristics present within all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee."|Day 15|Analysis shown is based on the Intent-to-Treat (ITT) population.|||percentage of participants|||Number
2555355|NCT02742441|Primary|"Percentage of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA)"|"The IGA score is a static evaluation of the overall or average degree of severity taking into account all of the subject's psoriatic lesions in the Treatment Area by the investigator or designee. This evaluation takes into consideration the three individual characteristics of psoriasis (scaling, erythema and plaque elevation) with the IGA score at each visit representing the average of scaling, erythema or plaque elevation that is present amongst all of the lesions eligible for treatment. IGA will be assessed on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe."|Day 15|Analysis shown is based on the intent-to-treat population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.|||percentage of participants|||Number
2555356|NCT02742129|Secondary|VO2 at Ventilatory Threshold (Submaximal Exercise Capacity) as Provided by Cardiopulmonary Exercise Testing Core Lab|To evaluate whether ARI001 in comparison to placebo improves submaximal exercise capacity as measured by VO2 (rate of oxygen consumption measured during incremental exercise) at ventilatory threshold during study drug administration.|End of Phase 1 & End of Phase 2|All patients randomized.|||ml/min||Standard Deviation|Mean
2555357|NCT02742129|Secondary|VE/VCO2 Slope (Ventilatory Efficiency) as Provided by Cardiopulmonary Exercise Testing Core Lab|To evaluate whether ARI001 in comparison to placebo improves ventilator efficiency as measured by Slope of Ve/VCO2 during study drug administration. The Ve/VCO2 slope is defined as the slope of the linear relationship between ventilation and carbon dioxide output and is a measure of the velocity.|End of Phase 1 & End of Phase 2|All patients randomized.|||unitless||Standard Deviation|Mean
2555358|NCT02742129|Secondary|Patient Preference for AIR001 Treatment at the End of Study|Self-reported participant preference for study period 1 (Phase 1) vs. study period 2 (Phase 2)|End of Phase 2|All randomized patients with available data.|||Participants|||Count of Participants
2555379|NCT02741687|Secondary|Total Daily Dose of Insulin for Patients Requiring Supplemental Insulin|Total daily dose of insulin for patients requiring supplemental insulin during surgery and recovery in participants receiving sitagliptin and those receiving the placebo|Up to time of discharge from hospital, an average of 10 days|The population for this analysis is limited to participants who received insulin during their hospital stay following surgery.|||international units of insulin|||Number
2555359|NCT02742129|Secondary|NYHA (New York Heart Association) Class|To evaluate whether AR001 improves NYHA Class in comparison to placebo. NYHA class was measured at the end of each phase. The site physician evaluated the patient based upon the criteria for NYHA class I-IV used by the American Heart Association. NYHA functional classification provides a way of classifying the extent of heart failure. Class I (least severe): No limitation of physical activity; Class II: Slight limitation of physical activity; Class III: Marked limitation of physical activity; Class IV (most severe): Unable to carry on any physical activity without discomfort.|End of Phase 1 & End of Phase 2|All patients randomized.|||Participants|||Count of Participants
2555360|NCT02742129|Secondary|N-terminal Pro-B-type Natriuretic Peptide Level (NT-proBNP)|Evaluate whether AIR001 improves natriuretic peptide levels in comparison to placebo|End of Phase 1 & End of Phase 2|All patients randomized.|||pg/mL||Standard Deviation|Mean
2555361|NCT02742129|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Score|To evaluate whether AR001 improves quality of life in comparison to placebo. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Higher values of the overall KCCQ score are considered to be better than lower values.|End of Phase 1 & End of Phase 2|All patients randomized.|||units on a scale||Standard Deviation|Mean
2555362|NCT02742129|Secondary|Pulmonary Artery Systolic Pressure as Measured by Echocardiography|To evaluate whether AIR001 improves pulmonary artery systolic pressure in comparison to placebo.|End of Phase 1 & End of Phase 2|All patients randomized.|||mmHg||Standard Deviation|Mean
2555363|NCT02742129|Secondary|Left Atrial Volume Index as Measured by Echocardiography|To evaluate whether AIR001 improves Left atrial volume index in comparison to placebo.|End of Phase 1 & End of Phase 2|All patients randomized.|||ml/m^2||Standard Deviation|Mean
2555364|NCT02742129|Secondary|Medial E/e' Ratio as Measured by Echocardiography Core Lab|To evaluate whether AIR001 improves Medial E/e' ratio (the ratio between early mitral inflow velocity and mitral annular early diastolic velocity for diastolic evaluation) in comparison to placebo.|End of Phase 1 & End of Phase 2|All patients randomized.|||ratio||Standard Deviation|Mean
2555365|NCT02742129|Secondary|Average Arbitrary Accelerometer Units (AAU)|Average arbitrary accelerometer units (AAU) during at least 14 days and up to 21 days of the maximally tolerated dose of study drug (from 28 days post Study Visit 1 until Study Visit 2 and from 28 days post Study Visit 2 until Study Visit 3). An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based upon patient movement. Higher values indicate more movement. Zero indicates no movement.|End of Phase 1 & End of Phase 2|All patients randomized.|||accelerometry units||Standard Deviation|Mean
2555366|NCT02742129|Primary|Peak VO2|The primary endpoint will be the peak VO2 after 4 weeks treatment with inorganic nitrite as compared to the peak VO2 after 4 weeks treatment with placebo as assessed by cardiopulmonary exercise testing (CPET) performed at peak drug levels.|End of Phase 1 & End of Phase 2|All patients randomized.|||ml/kg/min||Standard Deviation|Mean
2555367|NCT02741713|Secondary|Time From Block Placement to Onset of Axillary Pain|Time self-reported by patients in the Interscalene Plus PECS Blocks group during data collection phone call at 24 hours post-block.|Assessed 24hrs post-block in hours|This Outcome Measure was assessed only in the Interscalene Plus PECS Blocks group|||Hours||95% Confidence Interval|Mean
2555368|NCT02741713|Secondary|Total Opioid Usage|Recorded in oxycodone equivalents in the first 24 hours post-discharge from the PACU.|Assessed 24hrs post-block in mg||||mg||95% Confidence Interval|Mean
2555369|NCT02741713|Secondary|Percentage of Participants With Episodes of Nausea or Vomiting|Any episodes during the first 24 hours will be recorded as a yes.|Assessed 24hrs post-block (yes/no)||||percentage of participants|||Number
2555370|NCT02741713|Secondary|Numerical Rating Scale Pain Scores (0-10) at Rest|Subjects were asked about their overall shoulder pain during the followup phone call at 24hrs post-block. Numerical Rating Scale scores (0-10) will be recorded with 0= no pain, 10=most pain possible. Higher scores denotes worse outcome.|Assessed 24hrs post-block on a scale from 0-10.||||units on a scale||Inter-Quartile Range|Median
2555371|NCT02741713|Primary|Post-operative Axillary Pain|Post-operative ambulatory surgery subjects will be asked 6 hours after block placement about the presence of axillary pain at rest. Numerical Rating Scale scores (0-10) will be recorded with 0= no pain, 10=most pain possible. Higher scores denotes worse outcome.|6 hours post-block.||||units on a scale||Inter-Quartile Range|Median
2555372|NCT02741687|Secondary|Number of Participants Experiencing Complications|The number of subjects who experience complications including: wound infection, respiratory failure, pneumonia, acute kidney injury with a rise in creatinine by 38 micromoles/Liter from baseline, major adverse cardiac events, bacterial septic infection, and death. Participants will be followed for 30 days following hospital discharge and all complications will be documented.|Up to 40 days (average time of discharge from the hospital plus 30 days)||||Participants|||Count of Participants
2555373|NCT02741687|Secondary|Number of Participants With Emergency Room Visits After Discharge|Emergency room visits to the study hospital occurring within 30 days of hospital discharge were documented. There were no follow up phone calls or appointments with participants so any emergency room visits to hospitals other than the one where the surgery occurred are not known.|Up to 40 days (average time of discharge from the hospital plus 30 days)||||Participants|||Count of Participants
2555374|NCT02741687|Secondary|Number of Participants With Hospital Readmissions After Discharge|Readmissions to the study hospital occurring within 30 days of hospital discharge were documented. There were no follow up phone calls or appointments with participants so any hospital readmissions to hospitals other than the one where the surgery occurred are not known.|Up to 40 days (average time of discharge from the hospital plus 30 days)||||Participants|||Count of Participants
2555375|NCT02741687|Secondary|Number of Days in the ICU|The number of days a participant spent in the ICU following surgery, when transfer to the ICU was required.|Up to time of discharge from hospital, an average of 10 days|This analysis includes participants who were transferred to the ICU following surgery.|||days||Inter-Quartile Range|Median
2555381|NCT02741687|Primary|Number of Participants Experiencing Stress Hyperglycemia|The number of participants with at least one episode of stress hyperglycemia. Stress hyperglycemia is defined as a blood glucose > 180 mg/dL.|Up to time of discharge from hospital, an average of 10 days||||Participants|||Count of Participants
2555382|NCT02741518|Secondary|Assess Change of AUC of GLP-1 as a Therapeutic Biomarker for Clinical Response to Fecal Microbiota Transplantation From Baseline to Week 12|Fecal Microbiota Transplantation will lead to an increase in short chain fatty acids which will lead to an increase in the metabolic regulator GLP-1|12 weeks|Population analyzed includes all subjects except for the two subjects who withdrew mid study|||pg/ml x minutes||Standard Error|Mean
2555383|NCT02741518|Primary|Adverse Event Frequency|Number of patients reporting adverse events|6 months||||Participants|||Count of Participants
2555384|NCT02741310|Secondary|Number of Participants Who Developed Anti-erenumab Antibodies|"Two validated assays were used to detect the presence of anti-erenumab antibodies. All samples were first tested in an electrochemiluminescence-based bridging assay to detect antibodies capable of binding to erenumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based assay to determine neutralizing activity against erenumab (Neutralizing Antibody Assay). If a post-dose sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.~Binding/neutralizing antibody positive is defined as participants with an antibody positive postbaseline results and with a negative or no result at baseline."|Baseline and day 89|Participants who received at least 1 dose of study drug (placebo, sumatriptan, or erenumab) with a postbaseline antibody result.|||Participants|||Count of Participants
2555385|NCT02741310|Secondary|Maximum Observed Plasma Concentration (Cmax) of Sumatriptan|"Plasma concentrations of sumatriptan were quantified using a validated high performance liquid chromatographic method with tandem mass spectrometry detection. Sumatriptan plasma concentrations below the lower limit of quantification (LLOQ) (0.100 ng/mL) were set to 0 before data analysis.~Log-transformed maximum observed plasma concentration (Cmax) was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect. Sumatriptan Alone data include participants from both Groups A (Parts 1 and 2) and B (Part 1 only)."|Day 2 and day 5 at predose, 1 hour (prior to 2nd sumatriptan injection), 1 hour 10 minutes, 1.25, 1.5, 2, 3, 4.5, and 7 hours relative to the first 6 mg dose of sumatriptan.|All participants who received at least 1 dose of study drug (placebo, sumatriptan, or erenumab) and have at least one pharmacokinetic (PK) sample collected or one PK parameter.|||ng/mL||Standard Error|Geometric Least Squares Mean
2555386|NCT02741310|Secondary|Area Under the Concentration-time Curve From Time 0 to Infinity for Sumatriptan|"Plasma concentrations of sumatriptan were quantified using a validated high performance liquid chromatographic method with tandem mass spectrometry detection. The area under the plasma concentration-time curve from time 0 to infinity (AUCinf) after the 2nd 6 mg dose of sumatriptan was estimated as the sum of AUClast and Clast/λz where Clast is the last observed concentration and λz is the first-order terminal rate constant estimated via linear regression of the terminal log-linear decay phase. Sumatriptan plasma concentrations below the lower limit of quantification (LLOQ) (0.100 ng/mL) were set to 0 before data analysis.~Log-transformed AUCinf was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect. Sumatriptan Alone data include participants from both Groups A (Parts 1 and 2) and B (Part 1 only)."|Day 2 and day 5 at 1 hour (prior to 2nd sumatriptan injection), 1 hour 10 minutes, 1.25, 1.5, 2, 3, 4.5, and 7 hours relative to the first 6 mg dose of sumatriptan.|All participants who received at least 1 dose of study drug (placebo, sumatriptan, or erenumab) and have at least one pharmacokinetic (PK) sample collected or one PK parameter.|||hr*ng/mL||Standard Error|Geometric Least Squares Mean
2555387|NCT02741310|Secondary|Area Under the Concentration-time Curve From Time 0 to 6 Hours for Sumatriptan|"Plasma concentrations of sumatriptan were quantified using a validated high performance liquid chromatographic method with tandem mass spectrometry detection.~Area under the plasma concentration-time curve from time 0 to 6 hours post dose (AUC6hr) after the 2nd 6 mg dose of sumatriptan was estimated using the linear trapezoidal method. Sumatriptan plasma concentrations below the lower limit of quantification (LLOQ; 0.100 ng/mL) were set to 0 before data analysis.~Log-transformed AUC6hr was analyzed using a linear mixed effects model with treatment as a fixed effect and subject as a random effect.~Sumatriptan Alone data include participants from both Groups A (Parts 1 and 2) and B (Part 1 only)."|Day 2 and day 5 at 1 hour (prior to 2nd sumatriptan injection), 1 hour 10 minutes, 1.25, 1.5, 2, 3, 4.5, and 7 hours relative to the first 6 mg dose of sumatriptan.|All participants who received at least 1 dose of study drug (placebo, sumatriptan, or erenumab) and have at least one pharmacokinetic (PK) sample collected or one PK parameter.|||hr*ng/mL||Standard Error|Geometric Least Squares Mean
2555388|NCT02741310|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and according to the following:~Grade 1 = Mild AE, asymptomatic or mild symptoms; Grade 2 = Moderate, minimal, local or noninvasive intervention indicated; Grade 3 = Severe or medically significant but not immediately life-threatening; Grade 4 = Life-threatening consequences, urgent intervention indicated; Grade 5 = Death related to AE."|From the first dose of study drug (sumatriptan, placebo or erenumab) until 84 days after the last dose (89 days). Part 1 includes AEs from day 1 to predose on day 4 and Part 2 includes AEs from day 4 through day 89.|All participants who received at least 1 dose of study drug (placebo, sumatriptan, or erenumab).|||Participants|||Count of Participants
2555389|NCT02741310|Primary|Time-weighted Averages of Mean Arterial Pressure|"Mean arterial pressure (MAP) is the average arterial pressure during a single cardiac cycle. MAP was calculated as diastolic blood pressure (DBP) + 0.33 * (systolic blood pressure [SBP]-DBP). Individual time-weighted average in MAP were calculated as area under the measurement-time curve from predose through 2.5 hours of MAP divided by the time period over which the measurements were made (ie, AUCmap0-2.5 hr /2.5 hours).~Data were analyzed using a linear mixed effects regression model with fixed effects for treatment and period and random effect for subject; Sumatriptan Alone data include participants from both Groups A (Parts 1 and 2) and B (Part 1 only)."|Days 2 and 5 from predose to 2.5 hours after sumatriptan dosing.|All participants who received at least 1 dose of study drug (placebo, sumatriptan, or erenumab) and with available data.|||mmHg||Standard Error|Least Squares Mean
2560838|NCT02658877|Secondary|Change in Measures of Small Airway Dysfunction Using Impulse Oscillometry||16 Weeks of Treatment of omalizumab or placebo|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2555390|NCT02741297|Primary|Percentage of Low Back Pain Responders|Percentage of low back pain responders at 3 months post-activation with no increase in opioids from Baseline to 3 months post-activation|3 months|"For  All subjects without outlier sites, data for those sites with outlier subjects were removed."|||Participants|||Count of Participants
2555391|NCT02741284|Other Pre-specified|Umbilical Artery Malondialdehyde Concentration||At delivery||2020-04-30|04/2020||||
2555392|NCT02741284|Other Pre-specified|Resolution of Recurrent Decelerations||60 minutes after randomization||2020-03-31|03/2020||||
2555393|NCT02741284|Secondary|Umbilical Artery Base Deficit|As determined by cord gas collection at time of delivery|At time of delivery||||meq/L||95% Confidence Interval|Mean
2555394|NCT02741284|Secondary|Umbilical Artery pO2|Partial pressure of oxygen as collected on cord gases at time of delivery|Time of delivery||||mm Hg||95% Confidence Interval|Mean
2555395|NCT02741284|Secondary|Umbilical Artery pCO2|Partial pressure of carbon dioxide as collected on cord gases at time of delivery|At time of delivery||||mmHg||95% Confidence Interval|Mean
2555396|NCT02741284|Secondary|Mode of Delivery|Delivery via Cesarean section, operative vaginal delivery (forceps or vacuum), or spontaneous vaginal delivery|At delivery||||Participants|||Count of Participants
2555397|NCT02741284|Secondary|Umbilical Artery pH|Determined by umbilical artery cord gas collected at time of delivery and only in patients with paired (umbilical artery and umbilical vein) cord gases.|At time of delivery||||pH units||95% Confidence Interval|Mean
2555398|NCT02741284|Primary|Mean Umbilical Artery Lactate at Delivery|Determined by umbilical artery cord gas collected at time of delivery and only in patients with paired (umbilical artery and umbilical vein) cord gases.|At delivery||||mmol/L||95% Confidence Interval|Mean
2555399|NCT02741271|Secondary|Time to Maximum Plasma Concentration (Tmax) of Mometsone Furoate|Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial. Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment.|Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12|Participants who consented to take part in the PK sub-trial and had evaluable data for Tmax.|||hr||Full Range|Median
2555400|NCT02741271|Secondary|Maximum Plasma Concentration (Cmax) of Mometsone Furoate|Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial. Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment.|Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12|Participants who consented to take part in the PK sub-trial and had evaluable data for Cmax.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2555401|NCT02741271|Secondary|Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to Time of Last Measurable Concentration (AUC0-last)|Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial. Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment.|Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12|Participants who consented to take part in the PK sub-trial and had evaluable data for AUC(0-last).|||hr*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2555402|NCT02741271|Secondary|Area Under the Plasma Concentration-Time Curve of Mometasone Furoate From Time 0 to 12 Hours (AUC0-12)|Blood samples were collected predose, and 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12 in a subset of participants who consented to take part in a PK sub-trial. Per protocol, descriptive MF pharmacokinetics were summarized without regard to treatment assignment.|Predose, 0.75, 1.5, 3, 8, and 12 hours postdose at Week 12|Participants who consented to take part in the PK sub-trial and had evaluable data for AUC(0-12).|||hr*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2555403|NCT02741271|Secondary|Participants Whose SABA Rescue Medication Use Increased Across Weeks 1-12 of the Treatment Period|To evaluate the efficacy of MF/F MDI 100/10 mcg BID compared with MF MDI 100 mcg BID, the number of participants whose use of SABA rescue medication increased in Weeks 1-12 (individually) of the double-blind treatment period was assessed. All participants received SABA MDIs (albuterol 90 mcg or salbutamol 100 mcg) for relief of asthma symptoms.|Weeks 1-12 (Averaged)|Data were provided for all participants who received at least one dose of randomized trial medication and had at least one efficacy evaluation.|||Participants|||Number
2555404|NCT02741271|Secondary|Participants Using SABA Rescue Medication Across Weeks 1-12 of the Treatment Period|To evaluate the efficacy of MF/F MDI 100/10 mcg BID compared with MF MDI 100 mcg BID, the number of participants using SABA rescue medication in Weeks 1-12 (individually) of the double-blind treatment period was assessed. All participants received SABA MDIs (albuterol 90 mcg or salbutamol 100 mcg) for as-needed relief of asthma symptoms.|Baseline and Weeks 1-12 (Averaged)|Data were provided for all participants who received at least one dose of randomized trial medication and had at least one efficacy evaluation.|||Participants|||Number
2555405|NCT02741271|Secondary|Mean Change From Baseline in Total Daily Use of Short-Acting Beta-Agonist (SABA) Rescue Medication With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment|To evaluate the efficacy of MF/F MDI 100/10 mcg BID compared with MF MDI 100 mcg BID, the change from baseline in total daily short-acting beta-agonist (SABA) use (puffs per day) was averaged and assessed. All participants received SABA MDIs (albuterol 90 mcg or salbutamol 100 mcg) for as-needed relief of asthma symptoms. This secondary analysis of the change from baseline used the cLDA method without multiple imputation.A model-based MAR approach was used for missing data.|Baseline and Weeks 1-12 (Averaged)|All participants who received at least one dose of randomized trial medication with at least one efficacy evaluation|||Puffs per day||Standard Deviation|Mean
2555406|NCT02741271|Secondary|Change From Baseline in AM Pre-Dose % Predicted FEV1 With MF/F MDI 100/10 mcg BID or MF MDI 100 mcg BID Over the First 12 Weeks of Treatment|The change from baseline in AM pre-dose % predicted FEV1 with MF/F MDI 100/10 mcg BID vs MF MDI 100 mcg BID averaged over 12 weeks treatment was assessed. This secondary analysis of the change from baseline used the cLDA method without multiple imputation. A model-based MAR approach was used for missing data.|Baseline and Weeks 4, 8, and 12 (Averaged)|All participants who received at least one dose of randomized trial medication with at least one efficacy evaluation across the treatment period.|||Percent predicted FEV1||Standard Deviation|Mean
2560839|NCT02658877|Secondary|Change in Lung Function Measure by Spirometry Test||16 Weeks of Treatment of omalizumab or placebo|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2555407|NCT02741271|Secondary|Change From Baseline AM Post-Dose % Predicted FEV1 AUC 0-4 Hours on Day 1 and Week 12 of Treatment|This endpoint reflects changes in lung function data (forced expiratory volume in 1 second) measured across 0 to 4 hours post-dose on Day 1 and Week 12 compared to Baseline. Baseline was the average of 30 and 0 minutes pre-dose % predicted FEV1 values. The AUC was calculated over the scheduled timepoints of 0 min, 5 min, 15 min, 30 min, 60 min, 2 hr and 4 hr post-dose. Units are standardized to percent predicted FEV1 by dividing the AUC calculation by the duration of the observed AUC.|Baseline, Day 1 and Week 12|All participants who received at least one dose of randomized trial medication with at least one efficacy evaluation.|||Percent predicted FEV1||Standard Deviation|Mean
2555408|NCT02741271|Secondary|Change From Baseline AM Post-Dose Percent Predicted FEV1 on Day 1 of Treatment|The key secondary objective was to determine the onset of action for the efficacy of MF/F MDI 100/10 mcg BID, compared with MF MDI 100 mcg BID. The post-dose AM % predicted FEV1 was averaged sequentially, and the change from baseline on Day 1 was assessed. This key secondary endpoint was controlled for multiplicity in a step-down fashion, based on trial success defined as a statistically significant improvement in the primary endpoint for MF/F vs MF. Missing data were imputed using control-based multiple imputations with the cLDA model.|Baseline and Day 1, measured at 4 hr, 2 hr and 60, 30, 15, and 5 min, post-dose time points|All participants who received at least one dose of randomized trial medication with at least one efficacy evaluation|||Percent predicted FEV1||Standard Deviation|Mean
2555409|NCT02741271|Primary|Count (Percentage) of Participants Discontinuing From Study Medication Due to An AE|An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition temporally associated with the use of the Sponsor's product, is also an AE.|Up to 24 weeks|All randomized participants who received at least one dose of trial medication|||Participants|||Count of Participants
2555410|NCT02741271|Primary|Count (Percentage) of Participants Experiencing At Least One Adverse Event (AE)|An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition temporally associated with the use of the Sponsor's product, is also an AE.|Up to 26 weeks|All randomized participants who received at least one dose of trial medication.|||Participants|||Count of Participants
2555411|NCT02741271|Primary|Change From Baseline in Morning (AM) Post-Dose % Predicted Forced Expiratory Volume in One Second (FEV1) in the Area Under the Curve (AUC)0-60|This endpoint reflects changes in lung function data (forced expiratory volume in 1 second) measured across 0 to 60 minutes post-dose (at 0, 5, 15, 30 and 60 minutes) and averaged across study visits in the Treatment Period (Day 1, Week 1, Week 4, Week 8 and Week 12) compared to Baseline. Baseline was the average of % predicted FEV1 values at 30 min and 0 min pre-dose. At each visit, the area under the curve is calculated over the post-dose timepoints. Units are standardized to percent predicted FEV1 by dividing the AUC calculation by the duration of the observed AUC.|Baseline, and average of Day 1, Weeks 1, 4, 8, and 12|All participants who received at least one dose of randomized trial medication with at least one primary efficacy evaluation.|||Percent predicted FEV1||Standard Deviation|Mean
2555412|NCT02741245|Primary|Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN and Drug-Related Muscle Symptoms|Participants had CK levels assessed throughout the 52 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly-related to study drug were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
2555413|NCT02741245|Primary|Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN With Muscle Symptoms|Participants had CK levels assessed throughout the 52 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
2555414|NCT02741245|Primary|Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN|Participants had creatine phosphokinase (CK) levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
2555415|NCT02741245|Primary|Percentage of Participants With Potential Hy's Law Condition|Percentage of Participants with Potential Hy's Law Condition (defined as serum ALT or serum AST elevations >3xULN, with serum alkalinephosphatase <2xULN and total bilirubin (TBL) ≥2xULN) was summarized. The ALT and AST ULNs were 40 U/L. The ULN for alkaline phosphatase was 359 IU/L and the ULN for total bilirubin was 1.2 mg/dL.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
2555416|NCT02741245|Primary|Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) ≥10 Times Upper Normal Limit (ULN)|Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 10x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
2555493|NCT02739984|Secondary|Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
2555417|NCT02741245|Primary|Percentage of Participants Who Experience Elevation in Aspartate Aminotransferase (AST) ≥10 Times Upper Normal Limit (ULN)|Participants had AST levels assessed throughout the 12 week treatment period. Participants who had an assessments of AST that was 10x ULN or greater were recorded. The AST ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
2555418|NCT02741245|Primary|Percentage of Participants Who Experience Elevation in Alanine Aminotransferase (ALT) ≥10 Times Upper Normal Limit (ULN)|Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessments of ALT that was 10x ULN or greater were recorded. The ALT ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
2555419|NCT02741245|Primary|Percentage of Participants Who Experience Elevation in Aspartate Aminotransferase (AST) ≥5 Times Upper Normal Limit (ULN)|Participants had AST levels assessed throughout the 12 week treatment period. Participants who had an assessments of AST that was 5x ULN or greater were recorded. The AST ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
2555420|NCT02741245|Primary|Percentage of Participants Who Experience Elevation in Alanine Aminotransferase (ALT) ≥5 Times Upper Normal Limit (ULN)|Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessments of ALT that was 5x ULN or greater were recorded. The ALT ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
2555421|NCT02741245|Primary|Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) ≥3 Times Upper Normal Limit (ULN)|Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 3 x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
2555422|NCT02741245|Primary|Percentage of Participants Who Experience Consecutive Elevations in Aspartate Aminotransferase (AST) ≥3 Times Upper Normal Limit (ULN)|Participants had AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of AST that were 3 x ULN or greater were recorded. The AST ULN was 40 U/L..|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
2555423|NCT02741245|Primary|Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) ≥3 Times Upper Normal Limit (ULN)|Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT that were 3 x ULN or greater were recorded. The ALT ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
2555424|NCT02741245|Primary|Percentage of Participants Who Experience 1 or More Hepatitis-related AEs|Hepatitis-related AEs included Cholestasis, Cytolytic Hepatitis, Hepatic Cyst, Hepatic Failure, Hepatic Lesion, Hepatic Necrosis, Hepatitis, Hepatitis Cholestatic, Hepatitis Fulminant, Hepatitis Infectious, Hepatocellular Injury, Hepatomegaly, Jaundice, Jaundice Cholestatic.|up to 14 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
2555425|NCT02741245|Primary|Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs|Allergic Reaction or Rash AEs included Allergy to Arthropod Sting, Anaphylactoid Reaction, Anaphylactic Reaction, Anaphylatic Shock, Anaphylactoid Shock, Angioedema, Conjunctivitis Allergic, Contrast Media Reaction, Dermatitis, Dermatitis Allergic, Dermatitis Atopic, Dermatitis Bullous, Dermatitis Contact, Dermatitis Psoriasiform, Drug Hypersensitivity, Eczema, Eosinophila, Erythema, Eye Allergy, Face Oedema, Hypersensitivity, Mechanical Urticaria, Palmar Erythema, Periorbital Oedema, Photodermatosis, Photosensitivity Allergic reaction, Photosensitivity Reaction, Pigmentation Disorder, Pruritus, Pruritus Generalised, Rash, Rash Erythematous, Rash Follicular, Rash Generalised, Rash Maculo-Papular, Rash Papulosquamous, Rash Pruritic, Rash Pustular, Rash Vesicular, Rhinitis, Rhinitis Allergic, Rosacea, Skin Exfoliation, Skin Disorder, Skin Hyperpigmentation, Skin Lesion, Skin Mass, Skin Ulcer, Subcutaneous Nodule, Swelling Face, Systemic Lupus Erythematosus Rash, Urticaria.|up to 14 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
2555426|NCT02741245|Primary|Percentage of Participants Who Experience 1 or More Gallbladder-related AEs|Gallbladder-related AEs included Bile Duct Obstruction, Bile Duct Stone, Bile Duct Stenosis, Biliary Colic, Cholangitis, Cholecystectomy, Cholecystitis, Cholelithiasis, Gallbladder Disorder, Gallbladder Perforation, Hepatic Pain, and Hydrocholecystis.|up to 14 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
2555427|NCT02741245|Primary|Percentage of Participants Who Experience 1 or More Gastrointestinal-related AEs|Gastrointestinal-related AEs included all preferred terms within system organ class of Gastrointestinal Disorders except Chapped Lips and Toothache.|up to 14 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
2555428|NCT02741245|Primary|Percentage of Participants Who Had Study Drug Discontinued Due to Adverse Event|An AE was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants that had study drug discontinued due to an AE was summarized.|up to 12 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of participants|||Number
2555494|NCT02739984|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
2555429|NCT02741245|Primary|Percentage of Participants Who Experience at Least 1 Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized|up to 14 weeks|All randomized participants who received at least 1 dose of doubleblind study treatment and had available data for endpoint.|||Percentage of Participants|||Number
2555430|NCT02741245|Primary|Percentage Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C)|Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated. Results were reported as a M-estimate.|Baseline and Week 12|All randomized participants who received at least 1 dose of study drug, had baseline or post-baseline data and had baseline data for those analyses that required baseline data.|||Percentage Change||95% Confidence Interval|Mean
2555431|NCT02741076|Secondary|Sexual Function Measured Using the International Index of Erectile Function (IIEF) for Men and the Female Sexual Function Index (FSFI) for Women|For the International Index of Erectile Function (IIEF)(15-items) each question is scored on a scale of 0 or 1 to 5, with 0 as no sexual attempts, 1 as the highest frequency, and 5 as the lowest, except where 1=1-2, 2=3-4, 3=5-6, 4=7-10 attempts, and 5=11 or more attempts. Missing responses are scored as 0. For the Female Sexual Function Index (FSFI)(19 items) each question is scored on a scale of 0-5 or 1-5. The FSFI examines the following 6 domains with minimum and maximum scores as indicated: desire(1.2-6.0), arousal(0-6.0), lubrication(0-6.0), orgasm(0-6.0), satisfaction(0.8-6.0), and pain(0-6.0). A computational formula sums the scores within each domain and multiplies that sum by a prescribed weighting factor: desire 0.6, arousal 0.3, lubrication 0.3, orgasm 0.4, satisfaction 0.4, pain 0.4. Higher scores indicate greater functionality. The single final score range is 2.0 to 36, which is reported as an average for each group of female study participants as change from baseline.|Change from Baseline to 12 and 24 week visit|Intent to Treat Population|||Score on a scale||Standard Deviation|Mean
2555432|NCT02741076|Secondary|Patient Global Impression of Change (PGIC)|The Patient Global Impression of Change (PGIC) is a self-administered questionnaire that assesses the participant's level of improvement/worsening from the beginning to the end of treatment. Participants are asked to select the category of change that most closely describes any change experienced in the pain of their painful areas from the beginning of the Blinded Structured Opioid Discontinuation Period to Week 12 and to Week 24. The scale has levels describing change as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.|Baseline to 12 and 24 week visit|Intent to Treat Population|||Participants|||Count of Participants
2555433|NCT02741076|Secondary|Digit Symbol Substitution Test|Overall neuropsychological function is assessed using the DSST, a test that is sensitive to brain damage, dementia, age, and depression, and is a widely used instrument for measuring the neuropsychological effects of opioid therapy. The digits (1-9) are paired with symbols, and the test consists of matching the symbol for a series of digits as fast as possible. Score is number of correct symbols in 90 seconds. A decrease from baseline detects deterioration in processing speed. An increase from baseline detects improvement in processing speed.|Change from Baseline to 12 and 24 week visit|Intent to Treat Population|||Score on a test||Standard Deviation|Mean
2555434|NCT02741076|Secondary|Participant Reported Quality of Life Assessment Using Visual Analog Scale (EQ-5D-5L Standardized Instrument)|The EQ-5D-5L is a self-administered general measure of health outcome applicable to a wide range of health conditions and treatments. The visual analog scale (VAS) rates the subject's health on a 0-100 scale from the worst imaginable health state to the best imaginable health state.|Baseline to 12 and 24 week visit|Intent to Treat Population|||Score on a scale||Standard Deviation|Mean
2555435|NCT02741076|Secondary|Participant Reported Quality of Life Assessment Using EQ-5D-5L Standardized Instrument|The EQ-5D-5L is a self-administered general measure of health outcome applicable to a wide range of health conditions and treatments.The EQ-5D-5L measures quality of life in 5 dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression. Each is rated in 5 levels from no problems/pain/anxiety to being unable/extreme pain/extreme anxiety. The responses for each category are summarized by treatment and visit with frequencies and percentages reporting each level.|Baseline and weeks 12, 24|Intent to Treat Population|||Participants|||Count of Participants
2555436|NCT02741076|Secondary|Number of Participants Reporting Major or Severe Major Depression Using Patient Health Questionnaire Depression Scale (PHQ-8)|"The PHQ-8 is an 8-item questionnaire that aims at assessing the level of depression of a subject. Each item is scored from 0 = not at all to 3= nearly every day; the total score, which is the sum of the scores for each item, can be from 0 to 24. A score >= 10 is considered major depression and >= 20 is severe major depression."|Baseline, 12 and 24 week visit|Intent to Treat Population|||Participants|||Count of Participants
2555437|NCT02741076|Secondary|Change From Baseline in the Patient Health Questionnaire Depression Scale (PHQ-8)|"The PHQ-8 is an 8-item questionnaire that aims at assessing the level of mood of a subject. Each item is scored from 0 = not at all to 3= nearly every day; the total score, which is the sum of the score for each item, can be from 0 to 24. A score ≥10 is considered major depression and ≥20 is severe major depression."|Weeks 12 and 24|Intent to Treat Population|||Score on a scale||Standard Deviation|Mean
2555438|NCT02741076|Secondary|Participants Sleep Quantity Measured by Medical Outcomes Study (MOS)|Optimal Sleep Index is based on the average number of hours of sleep each night during the past 4 weeks. Index=1 represents 7-8 hours and Index=0 represents < 7 hours or > 8 hours.|4 weeks prior to baseline and prior to 12 and 24 week visits|Intent to Treat Population|||Participants|||Count of Participants
2555439|NCT02741076|Secondary|Change From Baseline on Sleep Quality Measured by Medical Outcomes Study (MOS)|"The MOS Sleep Scale is a 12-item questionnaire which measures sleep quality in 7 scales over the past 4 weeks: sleep disturbance, snoring, sleep short of breath or headache, sleep adequacy, sleep somnolence, and 2 sleep problems indexes. In addition, the average hours of sleep over the past 4 weeks is recorded as a raw measure and also coded as an optimal sleep index.~The MOS is scored and the sleep scales calculated according to the MOS Sleep Scale User's Manual v1.0 (Spritzer and Hays, 2003). The scores on the dimensions and the sleep indices were converted to a 0-100 scale, with higher scores reflecting more of the attribute implied by the name (e.g. greater sleep disturbance, greater sleep adequacy of sleep)."|Weeks 12 and 24|Intent to Treat Population|||Score on a scale||Standard Deviation|Mean
2555440|NCT02741076|Secondary|Number of Suboptimal Responders With Pain Intensity (PI) Score Worsening Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)|"Percent pain intensity difference (PID) relative to baseline is defined as 100* ((baseline Average PI - mean Average PI at visit)/baseline Average PI). The percentages are based on number of subjects in the Intent-to-Treat set per treatment group. PI is measured on the Numerical Ratings Scale (NRS). Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10.~This outcome measure applies only to Optimal Responders."|Weeks 12 and 24|Intent to Treat Population|||Participants|||Count of Participants
2555441|NCT02741076|Secondary|Number of Suboptimal Responders With Pain Intensity (PI) Score Improvement Relative to Baseline PI Measured on the 0-10 Numerical Ratings Scale (NRS)|"Percent pain intensity difference (PID) relative to baseline is defined as 100* ((baseline Average PI - mean Average PI at visit)/baseline Average PI). The percentages are based on number of subjects in the Intent-to-Treat set per treatment group. PI is measured on the Numerical Ratings Scale (NRS). Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10.~This outcome measure applies only to Suboptimal Responders."|Weeks 12 and 24|Intent to Treat Population|||Participants|||Count of Participants
2555442|NCT02741076|Secondary|Change in Mean Average Pain Intensity Score (PI) Score on the 0-10 Numerical Ratings Scale (NRS)|"Baseline is defined as the mean of the available Average PI scores on the 0-10 Numerical Ratings Scale (NRS) over the 7-day Baseline Period. For the scheduled post-randomization visits, mean Average Pain Intensity is defined as the means of the respective PI scores over the 7 days preceding the visit. If there is only one daily PI score available, the mean is not calculated, and the data point is considered missing.~PI = Pain Intensity. Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10."|From baseline to weeks 4, 8, 16, 20, and 24|Intent to Treat Population|||Score on a scale||Standard Deviation|Mean
2555443|NCT02741076|Primary|Change in the Mean Average Pain Intensity (PI) Score on the 0-10 Numerical Ratings Scale (NRS)|"Baseline is defined as the mean of the available Average PI scores on the 0-10 Numerical Ratings Scale (NRS) over the 7-day Baseline Period. For the scheduled post-randomization visits, mean Average Pain Intensity is defined as the means of the respective PI scores over the 7 days preceding the visit. If there is only one daily PI score available, the mean is not calculated, and the data point is considered missing.~PI = Pain Intensity. Higher scores indicate more pain intensity; lower scores less pain intensity. Scale range 0-10."|From baseline to the 1 week period prior to the Week 12 visit|Intent to Treat Population|||Score on a scale||Standard Deviation|Mean
2555444|NCT02740920|Secondary|Overall Response Rate Assessed by CT Scan|"To determine the overall response rate (complete + partial response)/total number of patients.~Response and progression will be evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee as well as the modified iRECIST guidelines. Response were assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|24 months|All patients who received the protocol treatment.|||Participants|||Count of Participants
2555445|NCT02740920|Primary|Measurement of Tumor Texture by CT Scan|To assess whether tumour texture parameters from a CT scan can differentiate patients who do and who do not respond to treatment with pembrolizumab. Trial closed due to slow accrual, analysis was no done for the primary outcome because data were not collected.|12 months|Trial closed due to slow accrual, analysis was no done for the primary outcome because data were not collected.||||||
2555446|NCT02740660|Secondary|Number of Participants With Adverse Events||Week 2, Week 4, Week 6, Week 8||||Participants|||Count of Participants
2555447|NCT02740660|Primary|Change in Weight With Caffeine/Albuterol||Baseline, Week 8||||kg||Standard Deviation|Mean
2555448|NCT02740660|Primary|Change in Lean Mass With Caffeine/Albuterol|DXA Scan of obese adolescents|Baseline, Week 8||||kg||Standard Deviation|Mean
2555449|NCT02740660|Primary|Change in Fat Mass With Caffeine/Albuterol|DXA Scan of obese adolescents|Baseline, Week 8||||kg||Standard Deviation|Mean
2555450|NCT02740413|Other Pre-specified|Average Cost for Replacement Treatment Related to Invasive Procedures|The average cost for replacement treatment related to invasive procedures was derived from the percentage of total costs for dispensed replacement therapy and calculated as: cost of factor concentrate used for invasive procedures/ total cost of factor concentrate.|Data analyzed on study start Day 1 for Year 1 (2005) and Year 7 (2011)|"MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product. Here, n= number of participants with available data for each category."|||percentage of cost||Standard Deviation|Mean
2555451|NCT02740413|Other Pre-specified|Average Annual Cost of Replacement Treatment Related to Invasive Procedures||Data analyzed on study start Day 1 for Year 1 (2005) and Year 7 (2011)|"MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product. Here, n= number of participants with available data for each category."|||SEK||Standard Deviation|Mean
2555452|NCT02740413|Secondary|Average Cost of Replacement Treatment Related to Invasive Procedures||For the duration of 11 years before the study start date (Day 1)|"MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product. Here, N= number of participants evaluable for this outcome measure."|||SEK||Standard Deviation|Mean
2555453|NCT02740413|Primary|Average Cost of Replacement Treatment (Benefix or Refacto/Refacto AF) Related to Bleed Event||For the duration of 11 years before the study start date (Day 1)|"MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product. Here, N= number of participants evaluable for this outcome measure."|||Swedish Krona (SEK)||Standard Deviation|Mean
2555495|NCT02739984|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
2555454|NCT02740413|Secondary|Average Annual Cost of Prescribed Factor Concentrate and Dispensed Replacement Treatment||For the duration of 11 years before the study start date (Day 1)|"MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product. Here, n= number of participants with available data for each category."|||SEK||Standard Deviation|Mean
2555455|NCT02740413|Primary|Average Relative Dose Intensity of Factor Concentrate Dispensed for Haemophilia A or B Participants on Prophylaxis Based on Dispensed Volume of Units|Relative dose intensity based on dispensed volume of units was calculated using annual dispensed volume of factor concentrate per participant divided by annual prescribed dose per participant. Data was analysed for 2 categories separately: children/adolescents and adults.|For the duration of 11 years before the study start date (Day 1)|"MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product. Here, n= number of participants with available data for each category."|||percentage of factor concentrate||Standard Deviation|Mean
2555456|NCT02740413|Primary|Percentage of Participants With Surgeries|Percentage of participants who had any type of surgery (arthrodesis, surgery on foot, nose, elbow, hand or shoulder, surgery on hip, surgery on knee, tooth extraction, venous port or any other) during the data observation period were reported.|For the duration of 11 years before the study start date (Day 1)|MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product.|||percentage of participants|||Number
2555457|NCT02740413|Primary|Haemophilia Joint Health Score|Haemophilia Joint Health Score (HJHS) was used to assess joint damage in participants with haemophilia. Total score ranges from 0 to 124, where, 0 indicates normal function, and 124 indicates worst joint function, higher values indicated more damage in joints.|Data analyzed on study start Day 1 for the duration of 6 years (2009 to 2015)|"MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product. Here, N= number of participants evaluable for this outcome measure."|||scores on a scale||Standard Deviation|Mean
2555458|NCT02740413|Primary|Gilbert Joint Score|"Gilbert joint score was an instrument to measure joint health in the domain of body structure and function (i.e. impairment), of the joints most commonly affected by bleeding in haemophilia - knees, ankles, elbows. Total score ranged from 0-100, evaluating ankle, knee and elbow, where 0 indicated normal joint function, 100 indicated worst joint function, where higher values indicated more impairment in joints."|Data analyzed on study start Day 1 for the duration of 4 years (2005 to 2009)|"MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product. Here, N= number of participants evaluable for this outcome measure."|||scores on a scale||Standard Deviation|Mean
2555459|NCT02740413|Primary|Number of Joint Bleed, Muscle Bleeds and Other Bleed Events in Participants|Joint bleeds included traumatic and spontaneous joint bleeds, muscle bleeds included traumatic and spontaneous soft tissue bleeds and other bleed events included intracranial bleed, gastrointestinal bleed and urinary tract bleed.|For the duration of 11 years before the study start date (Day 1)|MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product.|||bleeds|bleeds||Number
2555460|NCT02740413|Primary|Total Number of Bleeds||For the duration of 11 years before the study start date (Day 1)|"MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product. Here, N= number of participants evaluable for this outcome measure."|||bleeds||Standard Deviation|Mean
2555461|NCT02740413|Primary|Average Number of Units of Benefix or Refacto|Data from the National Board of Health and Welfare (NBHW) had information on all filled prescriptions from July 1, 2005-last date of observation (August 31, 2015). Derived variable calculated as total number of units of filled prescriptions of Refacto/Refacto AF and Benefix over the total units of all factor VIII concentrates and factor IX concentrates, respectively. Total number of units were derived from the date of start of NBHW to last available observation or date of death, whichever was earliest.|For the duration of 11 years before the study start date (Day 1)|"MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product. Here, n= number of participants with available data for each category."|||units||Standard Deviation|Mean
2555462|NCT02740413|Primary|Average Annual Number of Dispensed Units of Factor Concentrate|To assess annual consumption of factor concentrates, calculations were based on prescription date as start of use and the day before the next prescription as the last date of use of the factor concentrates retrieved. The annual number of dispensed units of factor concentrate were then summed up of all dispensed units of factor concentrate with periods within the calendar year plus estimates of average daily use periods extending over two years. Data at end of every year was based on the number of dispensed units of factor concentrate during the last 3 years.|For a duration of 3 years (for up to 11 years before the study start Day 1)|"MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product. Here, n= number of participants with available data for each category."|||dispensed units||Standard Deviation|Mean
2555496|NCT02739984|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12||Baseline and week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
2560840|NCT02658877|Secondary|Change in Score on Asthma Control Test||16 Weeks of Treatment of omalizumab or placebo|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2555463|NCT02740413|Primary|Average Annual Number of Filled Prescriptions of Factor Concentrate|Data at end of every year was based on the number of filled prescriptions during the last 3 years.|For a duration of 3 years (for up to 11 years before the study start Day 1)|"MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product. Here, n= number of participants with available data for each category."|||prescriptions||Standard Deviation|Mean
2555464|NCT02740413|Primary|Average Factor Concentrate Use at Hospital for Invasive Procedures|Average factor concentrate use was calculated as percentage of total annual use of factor concentrates (in IU) at hospital for invasive procedures.|For the duration of 11 years before the study start date (Day 1)|MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product.|||percentage of factor concentrate||Standard Deviation|Mean
2555465|NCT02740413|Primary|Average Use of Factor Concentrate Per Surgery Event at Hospital for Invasive Procedures||For the duration of 11 years before the study start date (Day 1)|MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product.|||IU per surgery event||Standard Deviation|Mean
2555466|NCT02740413|Primary|Percentage of Time on Refacto or Benefix|Percentage of time (in days) on Refacto/Refacto AF or Benefix was calculated as total number of days when participant was prescribed Refacto/Refacto AF or Benefix over the total number of days on any replacement treatment. Total number of days on any replacement treatment was derived from date of start of replacement treatment according to MHR and August 31, 2015 or date of death, whichever was earliest.|For the duration of 11 years before the study start date (Day 1)|"MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product. Here, N= number of participants evaluable for this outcome measure."|||days||Full Range|Median
2555467|NCT02740413|Primary|Number of Participants With Consumption of Factor VIII, Factor IX, Factor rVIIa and/or aPCC Concentrate|Participants who develop inhibitors to factor VIII or IX concentrates were treated with bypassing agents in the form of activated prothrombin complex concentrate (aPCC) which was measured in units (U) and/or recombinant factor VIIa (rFVIIa) measured in micrograms (mcg).|For the duration of 11 years before the study start date (Day 1)|MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product.|||Participants|||Count of Participants
2555468|NCT02740413|Primary|Average Annual Registered Consumption of Factor VIII and IX Concentrates|Participants diagnosed with coagulation disorders received intravenous replacement treatment of the missing coagulation factor (Factor VIII or IX). Average annual registered consumption of factor VIII and IX concentrates was defined as MHR registered participant's reports on factor concentrate consumption during calendar year.|For the duration of 11 years before the study start date (Day 1)|"MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product. Here, N= number of participants evaluable for this outcome measure."|||IU/year||Standard Deviation|Mean
2555469|NCT02740413|Primary|Average Prescribed Annual Dose of Factor VIII and IX Concentrates Per Kilogram Bodyweight for Participants on Prophylaxis|Participants diagnosed with coagulation disorders received intravenous replacement treatment of the missing coagulation factor (Factor VIII or IX). Prescribed annual dose of factor concentrate per kilogram body weight was derived from the MHR registration of prescribed annual dose of factor concentrate and the registered body weight.|For the duration of 11 years before the study start date (Day 1)|Analysis was performed on MHR Benefix or Refacto/Refacto AF analysis set. Here, “overall number of participants analysed” signifies participants who were evaluable for this outcome measure and “number analysed” signifies number of participants with available data for each category.|||IU/kg/year||Standard Deviation|Mean
2555470|NCT02740413|Primary|Average Prescribed Annual Dose of Factor VIII and IX Concentrates for Participants on Prophylaxis|Participants diagnosed with coagulation disorders received intravenous replacement treatment of the missing coagulation factor (Factor VIII or IX). Prescribed annual dose of factor concentrate was derived from the MHR registration of prescribed annual dose of factor concentrate.|For the duration of 11 years before the study start date (Day 1)|Analysis was performed on MHR Benefix or Refacto/Refacto AF analysis set. Here, “overall number of participants analysed” signifies participants who were evaluable for this outcome measure and “number analysed” signifies number of participants with available data for each category.|||IU/year||Standard Deviation|Mean
2555471|NCT02740413|Primary|Average Prescribed Frequency of Infusions Per Week Dispensed for Haemophilia A or B Participants With Prophylaxis||For the duration of 11 years before the study start date (Day 1)|"MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product. Here, N= number of participants with prophylaxis."|||infusions per week||Standard Deviation|Mean
2555472|NCT02740413|Primary|Percentage of Participants on Prophylactic Treatment|Prophylactic treatment was defined as administration of drug regularly to reduce the insufficiency of coagulation factor to prevent bleeding to occur.|For the duration of 11 years before the study start date (Day 1)|MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product.|||percentage of participants|||Number
2555497|NCT02739984|Secondary|Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
2555473|NCT02740413|Primary|Average Prescribed Dose Per Kilogram Bodyweight for Factor VIII and Factor IX Concentrates|The average dose per kilogram body weight of factor VIII and IX was defined as a set of two derived variables from the MHR based on information on prescribed replacement treatment (Benefix or Refacto/Refacto AF): prescribed dose per infusion divided by registered body weight (all participants) and prescribed dose per week (prescribed dose per infusion multiplied by registered number of infusions per week) divided by registered body weight (only participants on prophylaxis).|For the duration of 11 years before the study start date (Day 1)|"MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product. Here, n= number of participants with available data for each category."|||IU per kilogram||Standard Deviation|Mean
2555474|NCT02740413|Primary|Average Prescribed Dose Per Infusion for Factor VIII and Factor IX Concentrates|Participants diagnosed with coagulation disorders received intravenous replacement treatment of the missing coagulation factor (Factor VIII or IX). Data was measured in international units (IU) for factor VIII and factor IX concentrates.|For the duration of 11 years before the study start date (Day 1)|"MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product. Here, n= number of participants with available data for each category."|||IU||Standard Deviation|Mean
2555475|NCT02740413|Primary|Age of Participants at Start of Replacement Treatment|Participants diagnosed with coagulation disorders received intravenous replacement treatment of the missing coagulation factor. Replacement treatment could be given prophylactically or to stop the bleed and/or to stop it from becoming more severe.|At start of replacement treatment within 11 years before the study start date (Day 1)|MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product.|||years||Standard Deviation|Mean
2555476|NCT02740413|Primary|Age of Participants at Start of Treatment With Benefix or Refacto||At start of treatment with Benefix/Refacto within 11 years before the study start date (Day 1)|"MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product. Here, N= number of participants evaluable for this outcome measure."|||years||Standard Deviation|Mean
2555477|NCT02740413|Primary|Age of Participants at Disease Diagnosis||At disease diagnosis within 11 years before the study start date (Day 1)|"MHR Benefix or Refacto/Refacto AF analysis set: all participants diagnosed with haemophilia A or B in ICD-10, registered in MHR since 1977, had at least 1 registered prescription of Benefix or Refacto/Refacto AF in MHR since market authorization of respective product. Here, N= number of participants evaluable for this outcome measure."|||years||Standard Deviation|Mean
2555478|NCT02740049|Primary|Relative Fluorescence Units of STAT1 Protein Phosphorylation After Stimulation (IFN/TNF or IL13) and Treatment (VR588, FP or CP) Conditions in ALI Cultured Epithelial Cells.|Measurement of activation of phospho-STAT1 member of the JAK/STAT signaltransduction pathway in cell lysates. For this study epithelial cells from severe asthma patients (n = 9) were cultured and stimulated with either IFN/TNF or IL-13 to induce inflammation. Cells are then treated with VR588 (2 concentration) or with Fluticasone Propionate (FP) or with CP690553 (CP; Tofacitinib). The concentrations of drugs are listed in the title (e.g. 10-9M).|21 days|1 participant`s cell did not grow|||Relative Fluorescence Units||Standard Deviation|Mean
2555479|NCT02740049|Primary|Percentage of Viable Cells Compared to Baseline After Stimulation (IFN/TNF or IL13) and Treatment (VR588, FP or CP) Conditions in ALI Cultured Epithelial Cells.|Measurement of cell viability after stimulation of isolated epithelial cells. For this study epithelial cells from severe asthma patients (n = 9) were cultured and stimulated with either IFN/TNF or IL-13 to induce inflammation. Cells are then treated with VR588 (2 concentration) or with Fluticasone Propionate (FP) or with CP690553 (CP; Tofacitinib). The concentrations of drugs are listed in the title (e.g. 10-9M).|21 days|1 participant`s cell did not grow|||percentage against baseline||Standard Deviation|Mean
2555480|NCT02740049|Primary|Concentration (pg/ml) of CXCL8 Cytokine in Cell Supernatant After Stimulation (IFN/TNF or IL13) and Treatment (VR588, FP or CP) Conditions in ALI Cultured Epithelial Cells.|Measurement of cytokine levels in cell supernatant after stimulation of isolated epithelial cells. For this study epithelial cells from severe asthma patients (n = 9) were cultured and stimulated with either IFN/TNF or IL-13 to induce inflammation. Cells are then treated with VR588 (2 concentration) or with Fluticasone Propionate (FP) or with CP690553 (CP; Tofacitinib). The concentrations of drugs are listed in the title (e.g. 10-9M).|21 days|1 participant`s cell did not grow|||pg/ml||Standard Deviation|Mean
2555481|NCT02739997|Secondary|Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) by Pathogen at TOC|The percentage of participants with per-pathogen microbiological responses at TOC was determined. Individual pathogens were identified at baseline, and the overall percentage of participants with eradication or presumed eradication within each pathogen category are shown.|Day 28 (28 days after initiating study therapy)|Expanded microbiologically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, had a microbiological response at the TOC visit within the specified visit window, and have ≥1 identified intra-abdominal pathogen are included.|||Percentage of Participants||95% Confidence Interval|Number
2555482|NCT02739997|Secondary|Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) by Pathogen at EOT|The percentage of participants with per-pathogen microbiological responses at EOT was determined. Individual pathogens were identified at baseline, and the overall percentage of participants with eradication or presumed eradication within each pathogen category are shown.|Up to Day 14|Expanded microbiologically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, had a microbiological response at the EOT visit within the specified visit window, and have ≥1 identified intra-abdominal pathogen are included.|||Percentage of Participants||95% Confidence Interval|Number
2555483|NCT02739997|Secondary|Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) at TOC|"The percentage of participants with microbiological response (eradication, persistence, or indeterminate) at TOC was determined. Eradication was defined as absence of the baseline pathogen in a specimen. Persistence was defined as presence of the baseline pathogen in a specimen. Indeterminate was defined as Baseline culture either not obtained or has an assessment of no growth, or any other circumstance that makes it impossible to define the microbiological response."|Day 28 (28 days after initiating study therapy)|Expanded microbiologically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, had a microbiological response at the TOC visit within the specified visit window, and have ≥1 identified intra-abdominal pathogen are included.|||Percentage of Participants|||Number
2555484|NCT02739997|Secondary|Percentage of Participants With Microbiological Response (Eradication, Persistence, or Indeterminate) at EOT|"The percentage of participants with microbiological responses (eradication, persistence, or indeterminate) at EOT was determined. Eradication was defined as absence of the baseline pathogen in a specimen. Persistence was defined as presence of the baseline pathogen in a specimen. Indeterminate was defined as Baseline culture either not obtained or has an assessment of no growth, or any other circumstance that makes it impossible to define the microbiological response."|Up to Day 14|Expanded microbiologically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, had a microbiological response at the EOT visit within the specified visit window, and have ≥1 identified intra-abdominal pathogen are included.|||Percentage of Participants|||Number
2555485|NCT02739997|Secondary|Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at Late Follow-Up (LFU)|"The percentage of participants with clinical responses (cure, failure, or indeterminate) at LFU was determined. Clinical cure was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required. Clinical failure was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. Indeterminate was defined as study data are not available for evaluation for any reason, including death during the study period unrelated to the index infection; or extenuating circumstances that preclude classification as cure or failure."|Up to Day 42 (28 days after completing study therapy)|Clinically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, and had a clinical response at LFU visit within the specified visit window are included.|||Percentage of Participants|||Number
2555486|NCT02739997|Secondary|Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at End Of Therapy (EOT)|"The percentage of participants with clinical responses (cure, failure, or indeterminate) at EOT was determined. Clinical cure was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required. Clinical failure was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. Indeterminate was defined as study data are not available for evaluation for any reason, including death during the study period unrelated to the index infection; or extenuating circumstances that preclude classification as cure or failure."|Up to Day 14|Clinically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, and had a clinical response at EOT visit within the specified visit window are included.|||Percentage of Participants|||Number
2555487|NCT02739997|Primary|Percentage of Participants Discontinuing Study Drug Due to AEs|The percentage of participants withdrawing from study therapy due to an AE was determined.|Up to Day 14|All participants who received ≥1 dose of study therapy are included.|||Percentage of Participants||95% Confidence Interval|Number
2555488|NCT02739997|Primary|Percentage of Participants With Adverse Events (AEs)|The percentage of participants with ≥1 AEs was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.|Up to Day 42 (up to 28 days after completing study therapy)|All participants who received ≥1 dose of study therapy are included.|||Percentage of Participants||95% Confidence Interval|Number
2555489|NCT02739997|Primary|Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at Test of Cure (TOC)|"The percentage of participants with clinical responses (cure, failure, or indeterminate) at TOC was determined. Clinical cure was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required. Clinical failure was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. Indeterminate was defined as study data are not available for evaluation for any reason, including death during the study period unrelated to the index infection; or extenuating circumstances that preclude classification as cure or failure."|Day 28 (28 days after initiating study therapy)|Clinically evaluable participants were defined as those who received study therapy for ≥3 days, had 80-120% study therapy compliance, met criteria for cIAI, adhered to study procedures, and had a clinical response at the TOC visit within the specified visit window are included.|||Percentage of Participants|||Number
2555490|NCT02739984|Secondary|Percent Change From Baseline in VLDL-C at Week 12||Baseline and week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
2555491|NCT02739984|Secondary|Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
2555498|NCT02739984|Secondary|Percentage of Participants With at Least a 50% Reduction From Baseline in LDL-C at Week 12||Baseline and Week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percentage of participants||95% Confidence Interval|Number
2555499|NCT02739984|Secondary|Percentage of Participants With at Least a 50% Reduction From Baseline in Mean LDL-C at Weeks 10 and 12||Baseline and weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percentage of participants||95% Confidence Interval|Number
2555500|NCT02739984|Secondary|Percentage of Participants With LDL-C at Week 12 Less Than 70 mg/dL (1.8 mmol/L)||Week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percentage of participants||95% Confidence Interval|Number
2555501|NCT02739984|Secondary|Percentage of Participants With Mean LDL-C at Weeks 10 and 12 Less Than 70 mg/dL (1.8 mmol/L)||Weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percentage of participants||95% Confidence Interval|Number
2555502|NCT02739984|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12||Baseline and week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
2555503|NCT02739984|Secondary|Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
2555504|NCT02739984|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
2555505|NCT02739984|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
2555506|NCT02739984|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
2555507|NCT02739984|Secondary|Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
2555508|NCT02739984|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||mg/dL||Standard Error|Least Squares Mean
2555509|NCT02739984|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||mg/dL||Standard Error|Least Squares Mean
2555510|NCT02739984|Primary|Percent Change From Baseline in LDL-C at Week 12||Baseline and week 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
2555511|NCT02739984|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Randomized participants who received at least 1 dose of the study drug (placebo or evolocumab).|||percent change||Standard Error|Least Squares Mean
2555512|NCT02739828|Secondary|Percentage of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR) Over Time|"HiSCR is a clinical endpoint focusing on assessment of HS inflammatory signs and symptoms to determine the clinical effectiveness of adalimumab.~HiSCR requires:~At least a 50% reduction in the total abscess and inflammatory nodule count (AN count) relative to baseline, and~No increase in abscess count, and~No increase in draining fistula count. In first bullet AN count is defined as sum of abscess count and inflammatory nodules count."|Week 4, 12 and 24|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Observed cases with an assessment at given time point.|||percentage of participants||95% Confidence Interval|Number
2555513|NCT02739828|Secondary|Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 24: Participants Not Employed at Baseline|The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline, Week 24|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants not employed at Baseline with an assessment at Week 24.|||percent of impairment of activity||Standard Deviation|Mean
2555514|NCT02739828|Secondary|Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 12: Participants Not Employed at Baseline|The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline, Week 12|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants not employed at Baseline with an assessment at Week 12.|||percent of impairment of activity||Standard Deviation|Mean
2555515|NCT02739828|Secondary|Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 4: Participants Not Employed at Baseline|The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline, Week 4|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants not employed at Baseline with an assessment at Week 4.|||percent of impairment of activity||Standard Deviation|Mean
2555516|NCT02739828|Secondary|Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 24|The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline, Week 24|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline assessed at Week 24.|||percent of impairment of activity||Standard Deviation|Mean
2555517|NCT02739828|Secondary|Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 12|The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline, Week 12|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 12.|||percent of impairment of activity||Standard Deviation|Mean
2555518|NCT02739828|Secondary|Mean Change From Baseline in Overall Activity Impairment Due to Health Problem at Week 4|The 'overall activity impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall activity impairment due to health problem' was calculated based on 1 item: (Q6) to what degree did the disease impair the ability to do regular activities in the past 7 days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q6/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline, Week 4|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline at Week 4.|||percent of impairment of activity||Standard Deviation|Mean
2555519|NCT02739828|Secondary|Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 24|The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline, Week 24|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 24.|||percent of overall work impairment||Standard Deviation|Mean
2555520|NCT02739828|Secondary|Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 12|The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline, Week 12|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 12.|||percent of overall work impairment||Standard Deviation|Mean
2555521|NCT02739828|Secondary|Mean Change From Baseline in Overall Work Impairment Due to Health Problem at Week 4|The 'overall work impairment due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'overall work impairment due to health problem' was calculated based on 3 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit; (Q4) the number of actual work hours in the past 7 days from visit; and (Q5) to what degree did the disease impair the productivity while working past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline, Week 4|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 4.|||percent of overall work impairment||Standard Deviation|Mean
2555522|NCT02739828|Secondary|Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 24|The 'impairment while working due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'impairment while working due to health problem' was calculated based on 1 item: (Q5) to what degree did the disease impair the productivity while working in the past 7 days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline, Week 24|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 24.|||percent of impairment while working||Standard Deviation|Mean
2555523|NCT02739828|Secondary|Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 12|The 'impairment while working due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'impairment while working due to health problem' was calculated based on 1 item: (Q5) to what degree did the disease impair the productivity while working in the past 7 days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline, Week 12|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 12.|||percent of impairment while working||Standard Deviation|Mean
2555524|NCT02739828|Secondary|WPAI-SHP: Mean Change From Baseline in Impairment While Working Due to Health Problem at Week 4|The 'impairment while working due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'impairment while working due to health problem' was calculated based on 1 item: (Q5) to what degree did the disease impair the productivity while working in the past 7 days from visit. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/working). The data was calculated using the formula Q5/10 and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline, Week 4|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with an assessment at Week 4.|||percent of impairment while working||Standard Deviation|Mean
2555525|NCT02739828|Secondary|WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 24|The 'work time missed due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'work time missed due to health problem' was calculated based on 2 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit and (Q4) the number of actual work hours in the past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline, Week 24|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline and an assessment at Week 24.|||percent of work time missed||Standard Deviation|Mean
2555526|NCT02739828|Secondary|WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 12|The 'work time missed due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'work time missed due to health problem' was calculated based on 2 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit and (Q4) the number of actual work hours in the past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline, Week 12|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline and an assessment at Week 12.|||percent of work time missed||Standard Deviation|Mean
2555573|NCT02739321|Secondary|Total Time to Fall Asleep (Sleep Latency) Recorded by Actigraphy Watch|Within subjects comparison of sleep latency (minutes) recorded by actigraphy watch in the on and off conditions|Average of daily measure, across up to 2 weeks||||Minutes||Standard Error|Mean
2555527|NCT02739828|Secondary|WPAI-SHP: Mean Change From Baseline in Work Time Missed Due to Health Problem at Week 4|The 'work time missed due to health problem' was assessed using the WPAI-SHP questionnaire. WPAI-SHP is a 6-item participant-assessed questionnaire used to assess work and activity impairment due to symptoms of HS. The 'work time missed due to health problem' was calculated based on 2 items: (Q2) the number of hours missed from work due to health problems in the past 7 days from visit and (Q4) the number of actual work hours in the past 7 days from visit. The data was calculated using the formula Q2/(Q2+Q4) and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.|Baseline, Week 4|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants employed at Baseline with a Week 4 assessment.|||percent of work time missed||Standard Deviation|Mean
2555528|NCT02739828|Secondary|Change From Baseline in HSIA Overall Score at Week 24|The HSIA is a disease specific questionnaire measuring the impact the participant experiences associated with HS. HSIA consist of 18 sub-items, 16 of which range from 0 (no impact) to 10 (most negative impact), and 2 items register time at work/school and time away from work/school because of HS. Overall scores are presented as the percent of maximum HS impact (high values indicate a negative HS impact).|Baseline, Week 24|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 24.|||percent of maximum HS impact||Standard Deviation|Mean
2555529|NCT02739828|Secondary|Change From Baseline in HSIA Overall Score at Week 12|The HSIA is a disease specific questionnaire measuring the impact the participant experiences associated with HS. HSIA consist of 18 sub-items, 16 of which range from 0 (no impact) to 10 (most negative impact), and 2 items register time at work/school and time away from work/school because of HS. Overall scores are presented as the percent of maximum HS impact (high values indicate a negative HS impact).|Baseline, Week 12|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 12.|||percent of maximum HS impact||Standard Deviation|Mean
2555530|NCT02739828|Secondary|Change From Baseline in HSIA Overall Score at Week 4|The HSIA is a disease specific questionnaire measuring the impact the participant experiences associated with HS. HSIA consist of 18 sub-items, 16 of which range from 0 (no impact) to 10 (most negative impact), and 2 items register time at work/school and time away from work/school because of HS. Overall scores are presented as the percent of maximum HS impact (high values indicate a negative HS impact).|Baseline, Week 4|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 4.|||percent of maximum HS impact||Standard Deviation|Mean
2555531|NCT02739828|Secondary|Change From Baseline in EQ-5D VAS Score at Week 24|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better HRQL. 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Change in EQ-5D VAS score was calculated by deducting the final score from the baseline score. Increased scores correspond to better health state.|Baseline, Week 24|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 24.|||score on a scale||Standard Deviation|Mean
2555532|NCT02739828|Secondary|Change From Baseline in EQ-5D VAS Score at Week 12|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better HRQL. 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Change in EQ-5D VAS score was calculated by deducting the final score from the baseline score. Increased scores correspond to better health state.|Baseline, Week 12|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 12.|||score on a scale||Standard Deviation|Mean
2555533|NCT02739828|Secondary|Change From Baseline in EQ-5D VAS Score at Week 4|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where increased scores correspond to better HRQL. 0 is the 'worst imaginable health state' and 100 is the 'best imaginable health state'. Change in EQ-5D VAS score was calculated by deducting the final score from the baseline score. Increased scores correspond to better health state.|Baseline, Week 4|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 4.|||score on a scale||Standard Deviation|Mean
2555534|NCT02739828|Secondary|EQ-5D Questionnaire Responses at Week 24|"The EQ-5D is a participant assessment of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Participants report the extent of their problems with each of the 5 dimensions of health as some problems/no problems, some problems/no problems/unable to do, or none/moderate/extreme."|Baseline, Week 24|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 24.|||Participants|||Count of Participants
2555535|NCT02739828|Secondary|EQ-5D Questionnaire Responses at Week 12|"The EQ-5D is a participant assessment of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Participants report the extent of their problems with each of the 5 dimensions of health as some problems/no problems, some problems/no problems/unable to do, or none/moderate/extreme."|Baseline, Week 12|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 12.|||Participants|||Count of Participants
2555536|NCT02739828|Secondary|EQ-5D Questionnaire Responses at Week 4|"The EQ-5D is a participant assessment of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Participants report the extent of their problems with each of the 5 dimensions of health as some problems/no problems, some problems/no problems/unable to do, or none/moderate/extreme."|Baseline, Week 4|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 4.|||Participants|||Count of Participants
2555537|NCT02739828|Secondary|Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 24|The Participant's Global Assessment of Skin Pain NRS was used to assess the worst and average skin pain due to HS. NRS consists of 2 VAS response questions. Skin pain was rated from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) for each.|Baseline, Week 24|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 24.|||units on a scale||Standard Deviation|Mean
2555538|NCT02739828|Secondary|Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 12|The Participant's Global Assessment of Skin Pain NRS was used to assess the worst and average skin pain due to HS. NRS consists of 2 VAS response questions. Skin pain was rated from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) for each.|Baseline, Week 12|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 12.|||units on a scale||Standard Deviation|Mean
2555539|NCT02739828|Secondary|Change From Baseline in Participant's Global Assessment of Skin Pain - NRS at Week 4|The Participant's Global Assessment of Skin Pain NRS was used to assess the worst and average skin pain due to HS. NRS consists of 2 VAS response questions. Skin pain was rated from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) for each.|Baseline, Week 4|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 4.|||units on a scale||Standard Deviation|Mean
2555540|NCT02739828|Secondary|Change From Baseline in DLQI at Week 24|DLQI assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.|Baseline, Week 24|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 24.|||score on a scale||Standard Deviation|Mean
2555541|NCT02739828|Secondary|Change From Baseline in DLQI at Week 4|DLQI assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.|Baseline, Week 4|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 4.|||score on a scale||Standard Deviation|Mean
2555542|NCT02739828|Primary|Change From Baseline in DLQI at Week 12|DLQI assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.|Baseline, Week 12|Full Analysis Set (modified Intention-to-treat): All enrolled participants, with the exception of those who were enrolled and not treated with any dose of adalimumab, or who had no baseline or post baseline data collected for the primary analysis variable DLQI. Participants with an assessment at Week 12.|||score on a scale||Standard Deviation|Mean
2555543|NCT02739698|Primary|The Grouped Miller and Payne (MP) System for Pathological Response: G1 (Minimal Changes and < 30% Cells Tumour Reduction That Includes MP G1-G2), G3 (Microscopic Foci, Cells Tumour Reduction up to >90% That Includes MP G3-G4) and G5 (no Residual Tumour)|Histopathology scoring system to assess response, previous and post intraperitoneal intraoperative chemotherapy. Compare cancer cellularity of the biopsy (before treatment) with the other biopsy (after treatment).|The biopsies were taken before and after the treatment (intraperitoneal intraoperative chemotherapy for 60 minutes) and then they were analysed by two blinded pathologists.||||percentage of complete pathological resp|||Number
2555544|NCT02739594|Secondary|Percent Change From Baseline in CrCl|CrCl was calculated from blood samples using the Cockcroft-Gault formula, and was also measured by urinalysis. The percent change in CrCl was calculated as [Week 44 or 92 CrCl minus Baseline CrCl] divided by Baseline CrCl, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.|Baseline and Weeks 44, 92|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint. The number of participants who provided data within the specified timeframe for each analysis (n) is shown in the table."|||percent change||Standard Deviation|Mean
2555545|NCT02739594|Secondary|Percentage of Participants With Elevation of Serum Creatinine (SCr) From Baseline|Elevation in SCr was defined as an increase greater than (>) 0.5 milligrams per deciliter (mg/dL) for participants with Baseline SCr less than (<) 1.4 mg/dL, or an increase >1.0 mg/dL for participants with Baseline SCr greater than or equal to (≥) 1.4 mg/dL. For the Week 44 analysis, the last available value on/before Week 44 was used. For the Week 92 analysis, the last available value on/before Week 92 was used. The percentage of participants with elevation of SCr at Weeks 44 and 92 was reported.|Baseline and Weeks 44, 92|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2555560|NCT02739321|Secondary|Caregiver-Rated Measure of Ease of Mattress Technology Use as Measured by the Daily Sleep Diary|"Comparison of ease of mattress technology use, measured on a scale of 1-7 in which 1 is Extremely Difficult and 7 is Exceptionally Easy in mattress technology on condition to median score of 4 (average ease of use of mattress technology)."|Average of daily measure, across up to 2 Weeks||||units on a scale||Standard Error|Mean
2555546|NCT02739594|Secondary|Percent Change From Baseline in Gamma-Glutamyltransferase (GGT)|The percent change in GGT was calculated as [Week 44 or 92 GGT minus Baseline GGT] divided by Baseline GGT, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.|Baseline and Weeks 44, 92|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percent change||Full Range|Median
2555547|NCT02739594|Secondary|Percent Change From Baseline in Alpha (A) 1-Microglobulin|The percent change in A1-microglobulin was calculated as [Week 44 or 92 A1-microglobulin minus Baseline A1-microglobulin] divided by Baseline A1-microglobulin, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.|Baseline and Weeks 44, 92|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percent change||Full Range|Median
2555548|NCT02739594|Secondary|Percent Change From Baseline in N-Acetyl-Beta-D-Glucosaminidase (B-NAG)|The percent change in B-NAG was calculated as [Week 44 or 92 B-NAG minus Baseline B-NAG] divided by Baseline B-NAG, multiplied by 100. For the Week 44 analysis, the last available value on/before Week 44 was used in the calculation. For the Week 92 analysis, the last available value on/before Week 92 was used in the calculation.|Baseline and Weeks 44, 92|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data for the endpoint."|||percent change||Full Range|Median
2555549|NCT02739594|Secondary|Number of Zoledronate Dose Reductions for Each Participant|The number of zoledronate dose reductions was averaged across all participants, including those participants who did not have any dose reductions during the study.|From Baseline to end of study (up to Week 96)|ITT Population; only the Zoledronate arm was included.|||dose reductions||Standard Deviation|Mean
2555550|NCT02739594|Secondary|Percentage of Participants With Zoledronate Dose Reduction|The percentage of participants with at least 1 zoledronate dose reduction during the study was reported.|From Baseline to end of study (up to Week 96)|ITT Population; only the Zoledronate arm was included.|||percentage of participants||95% Confidence Interval|Number
2555551|NCT02739594|Secondary|Number of Events of Osteonecrosis of Jaw for Each Participant|The number of events of osteonecrosis of jaw was averaged across all participants, including those participants who did not experience the event during the study.|From Baseline to end of study (up to Week 96)|ITT Population.|||events of osteonecrosis of jaw||Standard Deviation|Mean
2555552|NCT02739594|Secondary|Percentage of Participants With Osteonecrosis of Jaw|The percentage of participants with at least 1 event of osteonecrosis of jaw during the study was reported.|From Baseline to end of study (up to Week 96)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2555553|NCT02739594|Secondary|Number of SREs for Each Participant|SREs were defined according to the Bondronat SmPC to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. The number of SREs was averaged across all participants, including those participants who did not experience SREs during the study.|From Baseline to end of study (up to Week 96)|ITT Population.|||SREs||Standard Deviation|Mean
2555554|NCT02739594|Secondary|Time to First SRE|SREs were defined according to the Bondronat SmPC to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. Time to first SRE was defined as the time from first dose of study drug to the time of SRE during the study. The median time to first SRE was estimated by Kaplan-Meier analysis and expressed in days.|From Baseline to end of study (up to Week 96)|ITT Population.|||days||Full Range|Median
2555555|NCT02739594|Secondary|Percentage of Participants With Skeletal-Related Events (SREs)|SREs were defined according to the Bondronat Summary of Product Characteristics (SmPC) to include radiotherapy to bone for treatment of fractures/impending fractures, surgery to bone for treatment of fractures, vertebral fractures, and non-vertebral fractures. The percentage of participants with at least 1 SRE during the study was reported.|From Baseline to end of study (up to Week 96)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2555556|NCT02739594|Primary|Percentage of Participants With Deterioration in Renal Function According to Reduction in CrCl From Baseline to Week 92|CrCl was calculated from blood samples using the Cockcroft-Gault formula. Relevant deterioration in renal function was defined as CrCl reduction of 30% from Baseline or an absolute value ≤30 mL/min at Week 92. The last available value on/before Week 92 was used in the calculation. The percentage of participants with deterioration in renal function at Week 92 was reported.|Baseline, Week 92|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2555557|NCT02739594|Primary|Percentage of Participants With Deterioration in Renal Function According to Reduction in Creatinine Clearance (CrCl) From Baseline to Week 44|CrCl was calculated from blood samples using the Cockcroft-Gault formula. Relevant deterioration in renal function was defined as CrCl reduction of 30 percent (%) from Baseline or an absolute value less than or equal to (≤) 30 milliliters per minute (mL/min) at Week 44. The last available value on/before Week 44 was used in the calculation. The percentage of participants with deterioration in renal function at Week 44 was reported.|Baseline, Week 44|Intent-to-Treat (ITT) Population.|||percentage of participants||95% Confidence Interval|Number
2555558|NCT02739360|Primary|Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths|The severity of Adverse Events were graded using the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03. An SAE was defined as an event that, at any dose, resulted in one or more of the following: 1) Death, 2) Life-threatening, 3) In-patient hospitalization or prolongation of existing hospitalization, 4) Persistent or significant disability/incapacity, 5) A congenital anomaly/birth defect, or 6) A medically important event or reaction.|Up to Day 602 plus 30 days|Safety Analysis Set: participants who took at least 1 dose of study drug.|||Participants|||Number
2555559|NCT02739321|Secondary|Caregiver-Rated Measure of Sleep Resistance as Measured by the Daily Sleep Diary|"Within subjects comparison of average difficulty for child to go to bed, measured on a scale of 1-7 in which 1 is Extremely Difficult and 7 is Exceptionally Easy, in the mattress technology on and off conditions."|Average daily measure, across up to 2 Weeks||||units on a scale||Standard Error|Mean
2555561|NCT02739321|Secondary|Caregiver-Rated Measure of Tolerance of the Actigraph Watch as Measured by the Daily Sleep Diary|"Comparison of average tolerance of the actigraph watch, measured on a scale of 1-7 in which 1 is Extremely Poor and 7 is Exceptional, across treatment conditions compared to median score of 4 (average toleration of actigraph watch)."|Average of daily measure, across up to 4 Weeks||||units on a scale||Standard Error|Mean
2555562|NCT02739321|Secondary|Caregiver-Rated Measure of Tolerance of Mattress Technology as Measured by the Daily Sleep Diary|"Comparison of average tolerance of mattress technology, measured on a scale of 1-7 in which 1 is Extremely Poor and 7 is Exceptional, in the on condition compared to the median score of 4 (average toleration of mattress technology)."|Average of daily measure, across up to 2 Weeks||||units on a scale||Standard Error|Mean
2555563|NCT02739321|Secondary|Caregiver-Rated Measure of Challenging Behavior/Task Compliance as Measured by the Daily Sleep Diary|"Within subjects comparison of average challenging behavior/task compliance, measured on a scale of 1-7 in which 1 is Extremely Difficult and 7 is Exceptional in the mattress technology on and off conditions"|Average of daily measure, across up to 2 Weeks||||units on a scale||Standard Error|Mean
2555564|NCT02739321|Secondary|Caregiver-Rated of Quality of Life as Measured by the CFQL-2 Questionnaire|"Within subjects comparison of the Child and Family Quality of Life 2 (CFQL-2), quality of life average total raw scores across baseline and on and off conditions.~The CFQL-2 is a parent questionnaire that evaluation seven different aspects of child and family quality of life (child, family, caregiver, financial, partner relationship, external support, and coping quality of life). An adapted version was used that decreased the number of total items from 32 to 26 and added an additional item to each scale to specifically evaluate changes of the past two weeks in quality of life. Items use a 5-point Likert scale ranging from (1=strongly disagree/decreased substantially to 3=neutral/same to 5=strongly agree/improved substantially). The total raw score was used to evaluate overall quality of life for child and family (Range=26-130). A lower, overall score indicates a lower quality of life for the child and their family."|Baseline, 2 weeks, 4 weeks||||units on a scale||Standard Error|Mean
2555565|NCT02739321|Secondary|Caregiver-Rated Sensory Issues Across Domains as Measured by the SSPQ|"Within subjects comparison of the Short Sensory Profile Questionnaire (SSPQ) average total raw scores across baseline and on and off conditions.~The SSPQ is a parent-completed questionnaire that measures behaviors related to sensory processing abnormalities. Items are based on a 5-point Liker scale ranging from 1=always to 5=never. The total raw score was used to evaluate overall sensory abnormalities (Range=38-190). Lower scores indicate a higher probability of sensory processing abnormalities."|Baseline, 2 weeks, 4 weeks||||units on a scale||Standard Error|Mean
2555566|NCT02739321|Secondary|Caregiver-Rated Sleep Disturbance as Measured by the Children's Sleep Habits Questionnaire (CSHQ)|"Within subjects comparison of the Children's Sleep Habits Questionnaire CSHQ average total raw scores across baseline and on and off conditions.~The CSHQ is a parent-completed questionnaire that measures a variety of sleep-related problems using a 3-point Likert-scale (1=rarely/0 to 1 times per week, 2= sometimes/2-4 times per week, 3=usually/5-7 times per week). Ordinarily, parents rate these behaviors for the pas week but for the present study they were instructed to rate for the past two weeks to correspond to the mattress on and off conditions. The total raw scores were use to evaluate overall sleep difficulties (Range = 45-135, in which a higher score is indicative of more sleep problems)."|Baseline, 2 weeks, 4 weeks||||units on a scale||Standard Error|Mean
2555567|NCT02739321|Secondary|Caregiver-Rated Problems With Sleep Habits as Measured by the FISH|"Within subjects comparison of the Family Inventory of Sleep Hygiene (FISH) average total raw scores across baseline, and on and off conditions.~The FISH is a parent-completed questionnaire that assesses sleep hygiene-related behaviors in children using a 5-point Likert scale (1=Never, 2=occasionally, 3=Sometimes, 4=Usually, 5=Always). Typically parents rate these behaviors with reference to the past month, but for the present study they were asked to rate for only the previous two weeks to correspond to each mattress condition. The total raw score was used to asses sleep hygiene (Range = 12-60, in which higher scores are indicative of better sleep hygiene-related behaviors)."|Baseline, 2 weeks, 4 weeks||||units on a scale||Standard Error|Mean
2555568|NCT02739321|Secondary|Caregiver-Rated Communication Problems as Measured by the CCC-2|"Within subjects comparison of the average Children's Communication Checklist (CCC-2) General Communication Composite standard scores across baseline, and on and off conditions.~CCC-2 is a parent questionnaire that assesses children's communication skills across 10 domains using a 4-point Likert type scale (0=less than once a week/never to 3=several times a day/always). The general communication composite standard score based on age norms was used to asses overall communication competency (M=100, SD=15). Lower general communication composite scores indicate a higher likelihood of significant communication problems."|Baseline, 2 weeks, 4 weeks||||Standard Score||Standard Error|Mean
2555569|NCT02739321|Secondary|Caregiver-Rated Severity Problem Behaviors as Measured by the Aberrant Behavior Checklist (ABC)|"Within subjects comparison of the parent completed Aberrant Behavior Checklist (ABC) total raw score in the baseline, and on and off conditions.~The ABC measures the level of challenging behavior of individuals in and across 5 subdomains (Irritability, lethargy, stereotypy, hyperactivity, inappropriate speech) using a Likert-type scale of 0-3 in which 0 is not at all a problem and 3 is the problem is severe in degree. The sum raw scores of these subdomains make up the total ABC raw score (range = 0-174) in which a higher score indicates more severe challenging behaviors."|Baseline, 2 weeks, 4 weeks||||units on a scale||Standard Error|Mean
2555570|NCT02739321|Secondary|Caregiver-Rated Severity of Social Deficits as Measured by the Social Responsiveness Scale 2 (SRS-2)|"Within subjects comparison of average Social Responsiveness Scale -2 (SRS-2) T-scores in baseline, and on and off conditions.~SRS-2 T-score ranges from 30-90 (M = 50, SD = 10). Higher T-scores indicate a greater extent of social communication deficits."|Baseline, 2 weeks, 4 weeks||||T-score||Standard Error|Mean
2555571|NCT02739321|Secondary|Percentage of Time in Bed That the Participant Spent Sleeping (Sleep Efficiency) Recorded by Actigraphy Watch.|Within subjects comparison of time spent sleeping (sleep efficiency as percentage) recorded by actigraphy in both the one and off conditions.|Average of daily measure, across up to 2 weeks||||percentage of time||Standard Error|Mean
2555572|NCT02739321|Secondary|Total Time Awake During Night Recorded by Actigraphy Watch|Within subjects comparison of total time awake during night (minutes) recorded by actigraphy watch in both on and off conditions|Average of daily measure, across up to 2 weeks||||Minutes||Standard Error|Mean
2555574|NCT02739321|Secondary|Total Time Asleep Recorded by Actigraphy Watch|Within subjects comparison of the average total sleep time (hours) in the on and off conditions as recorded by actigraphy watch|Average of daily measure, across up to 2 weeks||||Hours||Standard Error|Mean
2555575|NCT02739321|Secondary|Parent Reported Quality of Sleep Across Treatment Conditions|"Within subjects comparison of the average daily, parent reported sleep quality across on and off conditions using a Likert-type scale of 1-7 in which 1 is extremely poor and 7 is exceptional"|Average daily score, across up to 2 weeks||||units on a scale||95% Confidence Interval|Mean
2555576|NCT02739321|Primary|Compare Percentage of Participants Who Drop Out of Study as a Measure of Toleration of Mattress Technology|Compare percentage of drop-out, in this cohort, due to issues with the mattress technology (e.g. ease of use, inability to fall asleep) to a population expected drop-out rate of 30% using a one-sample proportion test.|up to 6 weeks||||Participants|||Count of Participants
2555577|NCT02739269|Secondary|Percentage of Subjects Requiring Step-up or Step-down of Gonadotrophin Dose Upon First Ultrasound Tracking|The dose of gonadotrophin will be adjusted according to the ovarian response: if 5 or less follicles growing beyond 10 mm --> step up if more than 15 follicles growing beyond 10 mm --> step down|8th day of ovarian stimulation|Intention-to-treat analysis. Two subjects in the AFC group did not proceed with treatment and were regarded as not requiring dosage adjustment.|||Participants|||Count of Participants
2555578|NCT02739269|Primary|Percentage of Subjects Having Desired Ovarian Response|Percentage of subjects with number of oocytes retrieved being between 6 and14|One single time point, i.e. at the time of oocyte retrieval|Intention-to-treat basis. Those not proceeding with ovarian stimulation or oocyte retrieval were regarded as not having desired ovarian response|||Participants|||Count of Participants
2555579|NCT02739100|Secondary|Number of Participants With Treatment-emergent Serious Adverse Events (TEAEs)|Safety will be documented by recording the incidence of treatment-emergent serious adverse events (TESAEs)|13 days|Safety Population (all enrolled subjects)|||Participants|||Count of Participants
2555580|NCT02739100|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|Safety will be documented by recording the incidence of treatment-emergent adverse events (TEAEs)|13 days|Safety Population (all enrolled subjects)|||Participants|||Count of Participants
2555581|NCT02739100|Primary|Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantified Concentration (AUC(Last)).|The PK will be done by assessing the mean area under the serum concentration-time curve from time zero to the time of the last quantified concentration (AUC(last)) and comparing between Triferic administered via hemodialysate and Triferic administered at a fixed IV dose of 6.6 mg iron/kg (pre-dialyzer and post-dialyzer) during a single dialysis session.|1, 2, 3, 4, 5, 6, 8, 10, and 12 hours|While all subjects were included in PK analysis, some PK samples were below the lower limit of quantitation (BLQ) of the bioanalytical lab assay. Therefore, the number of subjects analyzed differs from the overall total number of study participants.|||hours*microgram/deciliter||Standard Deviation|Mean
2555582|NCT02739100|Primary|Pharmacokinetics (PK) of Triferic Iron Administered Via Hemodialysate in Adult CKD-5HD Patients: Cmax.|The PK will be done by assessing the mean Cmax of total serum iron from Triferic administered via hemodialysate, compared to Triferic administered at a fixed IV dose of 6.6 mg iron/kg during a single dialysis session.|1, 2, 3, 4, 5, 6, 8, 10, and 12 hours||||microgram per deciliter||Standard Deviation|Mean
2555583|NCT02738879|Secondary|Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol at Week 30 and No Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L) up to Week 30|A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.|Week 30|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2555584|NCT02738879|Secondary|Percentage of Participants With Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L)|Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L).|Up to 30 weeks|All randomized participants who received at least one dose of study treatment.|||Percentage of participants||95% Confidence Interval|Number
2555585|NCT02738879|Secondary|Percentage of Participants With Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L)|Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L).|Up to 30 weeks|All randomized participants who received at least one dose of study treatment.|||Percentage of participants||95% Confidence Interval|Number
2555586|NCT02738879|Secondary|Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L)|Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant.|Up to 30 weeks|All randomized participants who received at least one dose of study treatment. Two participants in the sitagliptin group were not included in the primary analysis due to a missing value of a model covariate (race).|||Events/Participant-Years||95% Confidence Interval|Number
2555587|NCT02738879|Primary|Percentage of Participants Who Experienced One or More Adverse Events (AEs)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 32 weeks|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2555588|NCT02738879|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30|Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 30 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 30 minus FPG at Week 0).|Baseline and Week 30|All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline).|||mg/dL||95% Confidence Interval|Least Squares Mean
2560975|NCT02656290|Other Pre-specified|Subject's Average Red Blood Cells Count|Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.|Baseline, 6 months, and annually for up to 5 years|||||||
2555589|NCT02738879|Secondary|Percentage of Participants With A1C Goal <7.0% (<53 mmol/Mol) at Week 30|A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.|Week 30|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2555590|NCT02738879|Secondary|Percentage of Participants With Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L)|Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L).|Up to 30 weeks|All randomized participants who received at least one dose of study treatment.|||Percentage of participants||95% Confidence Interval|Number
2555591|NCT02738879|Secondary|Event Rate of Documented Hypoglycemia With Blood Glucose <56 mg/dL (≤3.1 mmol/L)|Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration <56 mg/dL (≤3.1 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant.|Up to 30 weeks|All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). Two participants (both in the sitagliptin group) were not included in the analysis due to a missing value of a model covariate (race).|||Events/Participant-Years||95% Confidence Interval|Number
2555592|NCT02738879|Secondary|Event Rate of Documented Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L)|Documented hypoglycemia is defined by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant.|Up to 30 weeks|All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline). Two participants (both in the sitagliptin group) were not included in the analysis due to a missing value of a model covariate (race).|||Events/Participant-Years||95% Confidence Interval|Number
2555593|NCT02738879|Secondary|Change From Baseline in Total Daily Insulin Dose (Units) at Week 30|Change from baseline reflects the Week 30 total daily insulin dose minus the Week 0 total daily insulin dose. The Week 0 total daily insulin dose was 0, by definition, because insulin was not administered at baseline.|Baseline and Week 30|All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline).|||Insulin Units||95% Confidence Interval|Least Squares Mean
2555594|NCT02738879|Secondary|Percentage of Participants With Events of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L)|Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The incidence (number of participants with ≥1 event divided by number of participants) of documented symptomatic hypoglycemia was determined.|Up to 30 weeks|All randomized participants who received at least one dose of study treatment.|||Percentage of participants||95% Confidence Interval|Number
2555595|NCT02738879|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 30 weeks|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2555596|NCT02738879|Primary|Event Rate of Documented Symptomatic Hypoglycemia With Blood Glucose ≤70 mg/dL (≤3.9 mmol/L)|Documented symptomatic hypoglycemia is defined as an event during which typical symptoms of hypoglycemia are accompanied by a measured (e.g., by fingerstick) plasma glucose concentration ≤70 mg/dL (≤3.9 mmol/L). The event rate was the total number of events divided by follow-up time (participant-years), including multiple events from the same participant.|Up to 30 weeks|All randomized participants who received at least one dose of study treatment. Two participants in the sitagliptin group were not included in the primary analysis due to a missing value of a model covariate (race).|||Events/Participant-Years||95% Confidence Interval|Number
2555597|NCT02738879|Primary|Change From Baseline in A1C at Week 30|A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 30 A1C minus the Week 0 A1C.|Baseline and Week 30|All randomized participants who received at least one dose of study treatment and had at least one measurement of the respective endpoint (baseline or post-baseline).|||Percent A1C||95% Confidence Interval|Least Squares Mean
2555598|NCT02738853|Secondary|Hemodynamic Performance - Total Prosthetic Regurgitation Graded as None/Trace|Total prosthetic regurgitation by transthoracic echocardiogram|30 days and 6 months|Only subjects with TTE could be analyzed.|||percentage of participants|||Number
2555599|NCT02738853|Secondary|Hemodynamic Performance - Mean Gradient|Mean gradient (mmHg) by transthoracic echocardiogram|baseline, 30 days, and 6 months|Only subjects with TTE could be analyzed.|||mmHg||Standard Deviation|Mean
2555600|NCT02738853|Secondary|Hemodynamic Performance - Aortic Valve Area|Aortic Valve Area (cm2) by transthoracic echocardiogram|baseline, 30 days, and 6 months|Only subjects with TTE could be analyzed.|||cm2||Standard Deviation|Mean
2555601|NCT02738853|Secondary|Device Success Rate (VARC II)||24 hours to 7 days||||percentage of participants||95% Confidence Interval|Number
2555602|NCT02738853|Secondary|Percentage of Participants With Valve-related Dysfunction Requiring Repeat Procedure|Percentage of participants with valve-related dysfunction requiring repeat procedure - VARC-II definition|30 days||||percentage of participants||95% Confidence Interval|Number
2555603|NCT02738853|Secondary|Percentage of Patient With Acute Kidney Injury- Stage 2 or 3|Percentage of participants with Acute kidney injury - Stage 2 or 3 - VARC-II definitions|30 days||||percentage of participants||95% Confidence Interval|Number
2555604|NCT02738853|Secondary|Percentage of Participants With Coronary Artery Obstruction|Percentage of participants with coronary artery obstruction - VARC-II definitions|30 days||||percentage of participants||95% Confidence Interval|Number
2555605|NCT02738853|Secondary|Percentage of Participants With Major Vascular Complication|Percentage of participants with major vascular complication - VARC-II definition|30 days||||percentage of participants||95% Confidence Interval|Number
2555606|NCT02738853|Secondary|Percentage of Participants With Life Threatening or Disabling Bleeding|Percentage of participants with life threatening or disabling bleeding - VARC-II definitions|30 days||||percentage of participants||95% Confidence Interval|Number
2555607|NCT02738853|Secondary|Event Rate of the VARC II Combined Safety Endpoint at 30 Days, Which Includes the Following Components:|"All-cause mortality~>~All stroke (disabling and non-disabling)~>~Life-threatening bleeding~>~Acute kidney injury: stage 2 or 3 (including renal replacement therapy)~>~Coronary artery obstruction requiring intervention~>~Major vascular complication~>~Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)"|30 days||||percentage of participants||95% Confidence Interval|Number
2555608|NCT02738853|Primary|The Percentage of Subjects With None or Trace Prosthetic Regurgitation on Echocardiogram||30 days|Only subjects with transthoracic echo (TTE) could be analyzed.|||percentage of participants||95% Confidence Interval|Number
2555609|NCT02738853|Primary|Stroke (Disabling) Rate||30 days||||percentage of participants||95% Confidence Interval|Number
2555610|NCT02738853|Primary|All-cause Mortality Rate||30 days||||percentage of participants||95% Confidence Interval|Number
2555611|NCT02738580|Primary|OVARIAN RESPONSE|NUMBER OF FOLICLES REACHED AND PUNCTURED AFTER CONTROLED OVARIAN STIMULATION|21 days||||folicles||95% Confidence Interval|Mean
2555612|NCT02738580|Primary|SERUM PROGSTERONE CONCENTRATION|Compare hormonal blood serum concentrations of progesterone during ovarian stimulation implied in follicular steroidogenesis during a cycle of Controlled Ovarian Stimulation with either r-FSH or HP-HMG.|21 days||||ng/mL||95% Confidence Interval|Mean
2555613|NCT02738333|Secondary|Percentage of Participants With Overall Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2555614|NCT02738333|Secondary|Change From Baseline in HCV RNA at Week 12||Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2555615|NCT02738333|Secondary|Change From Baseline in HCV RNA at Week 10||Baseline; Week 10|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2555616|NCT02738333|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2555617|NCT02738333|Secondary|Change From Baseline in HCV RNA at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2555618|NCT02738333|Secondary|Change From Baseline in HCV RNA at Week 5||Baseline; Week 5|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2555619|NCT02738333|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2555620|NCT02738333|Secondary|Change From Baseline in HCV RNA at Week 3||Baseline; Week 3|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2555621|NCT02738333|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2555622|NCT02738333|Secondary|Change From Baseline in HCV RNA at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2555623|NCT02738333|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2555624|NCT02738333|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 10||Week 10|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2555625|NCT02738333|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2555626|NCT02738333|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 6||Week 6|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2555627|NCT02738333|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 5||Week 5|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2555628|NCT02738333|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2555629|NCT02738333|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 3||Week 3|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2555630|NCT02738333|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2555631|NCT02738333|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 1||Week 1|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2555632|NCT02738333|Secondary|Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)|SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2555633|NCT02738333|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2555634|NCT02738333|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
2555635|NCT02738333|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and took at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2555636|NCT02738255|Secondary|Snoring Index in Simple Snorers|Snoring index is the number of breaths with snoring per hour of sleep. This was measured in both nights (night with Varnum mouthpiece and night without Varnum mouthpiece) only in simple snorers with AHI<10. The median of snoring index was compared between night with Varnum mouthpiece and night without Varnum mouthpiece.|Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece|This outcome was only calculated for simple snorers with AHI<10 events/hour.|||Snore/hour||Inter-Quartile Range|Median
2555637|NCT02738255|Secondary|Pharyngeal Collapsibility as Measured by Median Peak Inspiratory Flow During Sleep|The median peak flow during sleep was measured and compared on both nights (night with Varnum mouthpiece and night without Varnum mouthpiece). The median peak flow is a surrogate measure of upper airway collapsibility.|Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece||||L/s||Inter-Quartile Range|Median
2555638|NCT02738255|Primary|Sleep Apnea Severity as Measured by Apnea-hypopnea Index (AHI)|The number of respiratory events (apneas and hypopneas) per hour of sleep. This was measured on two nights in random order (night with Varnum mouthpiece and night without Varnum mouthpiece). The median AHI on the night with Varnum mouthpiece was then compared with median AHI on the night without Varnum mouthpiece.|Two nights: night with Varnum mouthpiece and night without Varnum mouthpiece||||Events/hour||Inter-Quartile Range|Median
2555639|NCT02738203|Secondary|Pain After Tenaculum Placement as Measured by a Visual Analog Scale|"Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale 0 had no pain and 100 had worst pain imaginable as anchors. A higher score indicates higher pain."|Intraoperative|Per protocol analysis|||score on a scale||Full Range|Median
2555640|NCT02738203|Secondary|Pain After Speculum Placement as Measured by a Visual Analog Scale|"Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale 0 had no pain and 100 had worst pain imaginable as anchors. A higher score indicates higher pain."|Intraoperative|Per protocol analysis|||score on a scale||Full Range|Median
2555641|NCT02738203|Secondary|Baseline Pain as Measured by a Visual Analog Scale|"Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale 0 had no pain and 100 had worst pain imaginable as anchors. A higher score indicates higher pain."|Immediately prior to procedure; upon arrival to procedure room|Per protocol analysis|||score on a scale||Full Range|Median
2555642|NCT02738203|Secondary|Anticipated Pain as Measured by a Visual Analog Scale|"Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale 0 had no pain and 100 had worst pain imaginable as anchors. A higher score indicates higher pain."|30 Minutes prior to procedure|Per protocol analysis|||score on a scale||Full Range|Median
2555643|NCT02738203|Primary|(IUD Insertion): Pain Perceived by Visual Analogue Scale (0-100 mm) Immediately Following Procedure Completion|"Pain immediately after speculum removal as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale 0 had no pain and 100 had worst pain imaginable as anchors. A higher score indicates higher pain."|0-3 minutes after procedure completed|Per protocol analysis|||score on a scale||Full Range|Median
2555644|NCT02738151|Secondary|Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal ) Event Rate Per Participant Year During Study Period|Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time).|Day 1-Week 12, Week 13-Week 24, and 24 Week Period|Safety population|||Events per participant year|||Number
2555645|NCT02738151|Other Pre-specified|Change From Baseline in Total Diabetes Treatment Satisfaction Questionnaire (DTSQ) Status at Week 12 and Week 24|The DTSQs is a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consists of 8 items that are answered on a Likert scale from 0 to 6. Total treatment satisfaction score is the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (high satisfaction with treatment). Adjusted least square means and standard errors were obtained from a mixed-effect model with MMRM.|Baseline, Week 12 and Week 24|ITT population. Number Analyzed = participants with at least one baseline and one post-baseline DTSQ status (DTSQs) total score.|||score on a scale||Standard Error|Least Squares Mean
2555646|NCT02738151|Secondary|Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) Event Rate Per Participant Year During Study Period|Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L).|Day 1-Week 12, Week 13-Week 24, and 24 Week Period|Safety population|||Events per participant year|||Number
2555647|NCT02738151|Secondary|Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal) by Study Period|Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycaemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time). Assessment was done by treatment period (for =<12 weeks, for >12 weeks to =<24 weeks).|Day 1-Week 12, Week 13-Week 24, and 24 Week Period|Safety population included all randomized participants who did actually receive at least one dose of IMP, regardless of the amount of treatment administered.|||percentage of participants|||Number
2555704|NCT02737163|Primary|Number of Encounters With Inadvertent Reprogramming of Strata CSF Shunt Valves.|Assessed by checking the valves at routine follow-up visits, in patient hospitalizations and prior to MRI imaging. The frequency will be calculated by the number of encounters/visits during which an assessed valve was inadvertently reprogrammed divided by the total number of encounters/visits in the trial. Here, we report the number of encounters/visits during which valves were inadvertently reprogrammed.|14 months||||Encounters|Encounters||Count of Units
2555648|NCT02738151|Secondary|Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) by Study Period|Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Assessment was done by treatment period (for =<12 weeks, for >12 weeks to =<24 weeks (24W)). Percentage of participants with at least one hypoglycemia (hypo) event at any time of the day were reported.|Day 1-Week 12, Week 13-Week 24, and 24 Week Period|Safety population.|||percentage of participants|||Number
2555649|NCT02738151|Secondary|Change From Baseline in Basal Insulin Dose (U/kg Body Weight) to Week 12 and Week 24|Only the insulin dose measurements performed before initiation of rescue therapy and during the on-treatment period were considered in the analysis.|Baseline, Week 12 and Week 24|Safety population included all randomized participants who did actually receive at least one dose of IMP, regardless of the amount of treatment administered.|||Units per kilogram (U/kg)||Standard Deviation|Mean
2555650|NCT02738151|Secondary|Percentage of Participants Requiring a Rescue Therapy During 24 Weeks Treatment Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. Threshold values at Week 12: FPG >200 mg/dL (11 mmol/L), or HbA1c >8.5%.|Baseline to Week 24|ITT population.|||percentage of participants|||Number
2555651|NCT02738151|Secondary|Percentage of Participants With Sulphonylurea or Meglitinide Dose Reduction/ Discontinuation Due to Hypoglycemia During 24 Weeks Treatment Period|Percentage of participants With Sulphonylurea or Meglitinide dose reduction/ discontinuation due to Hypoglycemia during 24 Week treatment period were reported. Only participants with Sulphonylurea or meglitinides at Screening as per actual strata were taken into account in this analysis.|Baseline to Week 24|ITT population.|||percentage of participants|||Number
2555652|NCT02738151|Secondary|Percentage of Participants Reaching Target HbA1c <7% and =<6.5% at Week 12 and Week 24 Without Severe and/or Confirmed Hypoglycemia (70 mg/dL) Event|Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed by plasma glucose =<3.9 mmol/L (=<70 mg/dL).|Week 12, and Week 24|ITT population.|||percentage of participants|||Number
2555653|NCT02738151|Secondary|Percentage of Participants Reaching Target HbA1c of < 7% and =<6.5% at Week 12 and Week 24|Only the post-baseline HbA1c measurements before rescue and during the 12 week and 24-week on-treatment period were considered in the analysis.|Week 12, and Week 24|ITT population.|||percentage of participants|||Number
2555654|NCT02738151|Secondary|Change From Baseline in Variability of 24-Hour 8-Point SMPG Profiles at Week 12 and Week 24|Adjusted LS means were obtained from MMRM.|Baseline, Week 12 and Week 24|ITT population. Here, number analyzed = Participants with at least one baseline and one post-baseline 24-hour average SMPG values at specified time points.|||percentage of mean variability||Standard Error|Least Squares Mean
2555655|NCT02738151|Secondary|Change From Baseline in Variability of Fasting SMPG to Week 12 and Week 24|Adjusted LS means were obtained from MMRM. Variability was assessed by the mean of coefficient of variation calculated over at least 3 SMPG measured during the 7 days preceding the given visit.|Baseline, Week 12 and Week 24|ITT population. Number Analyzed = participants with at least one baseline and one post baseline Fasting SMPG values at specified time point.|||percentage of mean variability||Standard Error|Least Squares Mean
2555656|NCT02738151|Secondary|Change From Baseline in 24-hour Average 8-point SMPG Profile to Week 12 and Week 24|The 8-point SMPG profile was measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Adjusted LS means were obtained from MMRM.|Baseline, Week 12 and Week 24|ITT population. Here, number analyzed = Participants with at least one baseline and one post-baseline 24-hour average SMPG values at specified time points.|||mmol/L||Standard Error|Least Squares Mean
2555657|NCT02738151|Secondary|Change From Baseline in 4-point SMPG Profile to Week 12 and Week 24 Per Time Point|4-point SMPG profiles were measured at the following 4 points: prebreakfast, prelunch, predinner and bedtime.|Baseline, Week 12 and Week 24|ITT population. Number analyzed = Participants with at least one baseline and one post-baseline 4-point SMPG values at specified timepoints.|||mmol/L||Standard Deviation|Mean
2555658|NCT02738151|Secondary|Change From Baseline in 8 Point SMPG Profile to Week 12 and Week 24 Per Time Point|8-point SMPG profiles were measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime.|Baseline, Week 12 and Week 24|ITT population. Number Analyzed = participants with at least one baseline and one post baseline 8 Point SMPG values at specified time point.|||mmol/L||Standard Deviation|Mean
2555659|NCT02738151|Secondary|Change From Baseline in Fasting Self-Monitoring Plasma Glucose (SMPG) to Week 12 and Week 24|Fasting SMPG was measured by the participant before breakfast and before the administration of the glucose-lowering agents once a day during the study. Adjusted LS means were obtained from MMRM including post baseline values during the 24 week on treatment period.|Baseline, Week 12 and Week 24|ITT population. Here, overall number analyzed =participants with at least one baseline and one post baseline fasting SMPG values at specified timepoints.|||mmol/L||Standard Error|Least Squares Mean
2555660|NCT02738151|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 and Week 24|Change in FPG was calculated by subtracting baseline value from Week 12 and Week 24 value. Adjusted LS means were obtained from MMRM including post baseline values during the 24-week on-treatment period.|Baseline, Week 12 and Week 24|ITT population. Here, number analyzed = participants with at least one baseline and one post baseline FPG values at specified timepoints.|||mmol/L||Standard Error|Least Squares Mean
2555661|NCT02738151|Secondary|Change From Baseline in HbA1c to Week 12|Change in HbA1c was calculated by subtracting baseline value from Week 12 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with MMRM.|Baseline, Week 12|ITT population. Here, overall number of participants analyzed = participants with at least one baseline and one post-baseline HbA1c assessment during the 12 week on-treatment period.|||percentage of HbA1c||Standard Error|Least Squares Mean
2555662|NCT02738151|Primary|Change From Baseline in HbA1c to Week 24|Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Adjusted Least Square (LS) means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the 24-week on-treatment period.|Baseline, Week 24|Intent-to-treat(ITT) population: all randomized participants who received at least 1 dose of IMP, regardless of whether treatment was actually being received & analyzed as per allocated treatment group. Overall number of participants analyzed=participants with at least 1 baseline & 1 post-baseline HbA1c assessment during 24week on-treatment period.|||percentage of HbA1c||Standard Error|Least Squares Mean
2555663|NCT02738138|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|Per protocol, all efficacy analyses were performed using the ITT population including only those participants who had post-treatment data available, excluding reinfection (N = 151). In addition, efficacy analyses were performed overall, combining Treatment Arms A and B.|||percentage of participants||95% Confidence Interval|Number
2555664|NCT02738138|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Up to 12 weeks|Per protocol, all efficacy analyses were performed using the ITT population; in addition, efficacy analyses were performed overall, combining Treatment Arms A and B.|||percentage of participants||95% Confidence Interval|Number
2555665|NCT02738138|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of active study drug.|12 weeks after last dose of study drug|Per protocol, all efficacy analyses were performed using the intention-to-treat (ITT) population (all enrolled participants who received at least 1 dose of study drug); in addition, efficacy analyses were performed overall, combining Treatment Arms A and B.|||percentage of participants||95% Confidence Interval|Number
2555666|NCT02738086|Secondary|Late Life Function and Disability Scale, Limitation|The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.|6 months||||score on a scale||95% Confidence Interval|Mean
2555667|NCT02738086|Secondary|Late Life Function and Disability Scale, Limitation|The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.|3 months||||score on a scale||95% Confidence Interval|Mean
2555668|NCT02738086|Secondary|Late Life Function and Disability Scale, Frequency|The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.|6 months||||score on a scale||95% Confidence Interval|Mean
2555669|NCT02738086|Secondary|Accelerometer-Based Physical Activity|Physical activity counts will be measured using a waist-mounted accelerometer-based physical activity monitor (Actigraph). The outcome will be average daily physical activity counts.|6 months||||Steps||95% Confidence Interval|Mean
2555670|NCT02738086|Secondary|Late Life Function and Disability Scale, Frequency|The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.|3 months||||score on a scale||95% Confidence Interval|Mean
2555671|NCT02738086|Secondary|Accelerometer-Based Physical Activity|Physical activity counts will be measured using a waist-mounted accelerometer-based physical activity monitor (Actigraph). The outcome will be average daily physical activity counts.|3 months||||Steps||95% Confidence Interval|Mean
2555672|NCT02738086|Primary|Study-Related Adverse Events|Safety will be assessed as differences in rates of study-related adverse events between GROUP 1 and GROUP 2 during the first three months, when GROUP 1 is in the intervention phase and GROUP 2 is in the non-intervention control phase.|3 months||||Adverse Events|||Number
2555673|NCT02738086|Primary|Acceptability|Acceptability will be measured using the mean score of the Intrinsic Motivation Inventory - Interest / Enjoyment Subscale. The scores range from 1 to 7, with higher numbers indicating higher acceptability, and a null value of 5.0.|3 months||||score on a scale||Standard Deviation|Mean
2555674|NCT02738086|Primary|Dose Goal Attainment|Dose goal attainment will be measured as the percent of participants in the intervention phase of the study who meet the dose goal of an average 3% increase in daily steps.|3 months||||Participants|||Count of Participants
2555675|NCT02738086|Primary|Retention Rate|Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.|3 months||||Participants|||Count of Participants
2555676|NCT02738008|Secondary|Percentage of Initial Responders to ARC-520 Therapy With HBsAg Loss (Qualitative) Compared to Baseline Over Time|The qualitative HBsAg assay gives a binary result, positive or negative. Baseline is defined as the average of the pre-dose values in the primary Heparc-2002 and Heparc-2003 studies.|Baseline, Weeks 36, 48, and 60|The study was terminated prior to any participant reaching Week 36 of treatment; therefore, this outcome measure could not be analyzed.||||||
2555715|NCT02736890|Secondary|Dynamic Mechanical Allodynia Testing|Dynamic allodynia will be tested by stroking the affected region gently with a cotton swab, 4 times at a rate of 3-5cm per second over an area of 5cm. If there is an evoked clear sensation of pain, the subject is asked to rate the intensity of dynamic allodynia using the 11-point NRS. The region of static and dynamic allodynia, if present, will be marked and recorded|up to 12 weeks post-injection, for a total of 24 weeks from baseline|Data initially collected incorrectly, then data not collected.||||||
2555844|NCT02734940|Primary|Pain Scores - Numerical Rating Scale, 0-10|Pain scores recorded 24 hours post extubation by acute pain services nurses (who will be blinded)|24 hours|The study was terminated because of lack of enrollment. No data was collected.||||||
2555677|NCT02738008|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An adverse event (AE) is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. An SAE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction. A TEAE was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.|From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up|Safety Population: all participants who received at least 1 dose of study medication and had at least 1 post-dose safety assessment.|||Participants|||Count of Participants
2555678|NCT02738008|Primary|Percentage of Initial Responders to ARC-520 Therapy Achieving a 1-log Reduction in HBsAg at Week 36 Compared to Baseline|Initial responders are defined as participants who showed a ½ log or greater reduction in their serum HBsAg levels from baseline to Day 71 ± 3 days of the primary Heparc-2002 and Heparc-2003 studies, where baseline is defined as the average of pre-dose values.|Baseline, Week 36|The study was terminated prior to any participant reaching Week 36 of treatment; therefore, this outcome measure could not be analyzed.||||||
2555679|NCT02737917|Secondary|Rates of Desaturation|number of patients per group that desaturated to less than 90% and less than 80%|within 2 minutes of confirmation of endotracheal tube placement|All patients undergoing rapid sequence intubation receiving either Apneic Oxygenation or Usual Care|||Participants|||Count of Participants
2555680|NCT02737917|Primary|Mean (Average) Arterial Oxygen Saturation|the average oxygen saturation as measured by peripheral capillary oxygen saturation (SpO2)|within 2 minutes of confirmation of endotracheal tube placement||||Percent Saturation (SpO2)||95% Confidence Interval|Mean
2555681|NCT02737852|Primary|Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale|Number of subjects with observed local edema by obstetrician/gynecologist examination as graded on 5 point clinical scale: 0 = normal appearance no edema, 0.5 = slight edema, 1 = mild edema, 2 = moderate edema 3 = severe edema|2 weeks||||Participants|||Count of Participants
2555682|NCT02737852|Primary|Number of Subjects With Observed Local Erythema Based on the 5 Point Scoring Scale|Number of subjects with observed local erythema by obstetrician/gynecologist examination as graded on 5 point clinical scale: 0 = normal appearance no irritation, 0.5 = slight, irregular erythema, 1 = mild erythema, 2 = moderate erythema 3 = severe erythema|2 weeks||||Participants|||Count of Participants
2555683|NCT02737722|Post-Hoc|Median Percent Change From Baseline in the Percentage Area Reduction for Ulcers in the Per-Protocol Population|Percent change from Baseline is calculated as the [(post-Baseline value minus the Baseline value)/Baseline value] x 100. Baseline is defined as the last non-missing value obtained prior to receiving study drug. For participants who have more than one ulcer, the measurement of all ulcers were combined for analysis.|Baseline; Day 15 (Visit 5)|Per-Protocol Population. Only those participants with available data were analyzed.|||percent change||Full Range|Median
2555684|NCT02737722|Post-Hoc|Percentage of Participants With a Positive and Negative Global Clinical Impression of Microbiology Response|Global impression of microbiological response was conducted by comparing culture value from Baseline to Visit 5 (Day 15). If culture values were not reported by the local laboratory, numerical values were assigned using the following criteria: heavy growth, 4+, moderate growth, 2+, scant, 1+, no bacteria, 0.|Baseline; Day 15 (Visit 5)|Per-Protocol Population. Microbiology results were not collected in the database for participants in the 0.1% cohort.|||percentage of participants|||Number
2555685|NCT02737722|Secondary|Mean Change From Baseline in the Percentage of Area Reduction for Ulcers in the Per-Protocol Population|Change from Baseline is calculated as the post-Baseline value minus the Baseline value. Baseline is defined as the last non-missing value obtained prior to receiving study drug. For participants who have more than one ulcer, the measurement of all ulcers were combined for analysis.|Baseline; Day 15 (Visit 5)|Per-Protocol Population. Only those participants with available data were analyzed.|||percentage of area||Standard Deviation|Mean
2555686|NCT02737722|Secondary|Mean Change From Baseline in Ulcer Area in the Per-Protocol Population|Change from Baseline is calculated as the post-Baseline value minus the Baseline value. Baseline is defined as the last non-missing value obtained prior to receiving study drug. For participants who have more than one ulcer, the measurement of all ulcers were combined for analysis.|Baseline; Day 15 (Visit 5)|Per-Protocol Population: all participants who met enrollment criteria, received all doses of investigational product as required by the protocol, and had no major protocol violations. Only those participants with available data were analyzed.|||centimeters squared (cm^2)||Standard Deviation|Mean
2555687|NCT02737722|Secondary|Mean Change From Baseline in the Percentage of Area Reduction for Ulcers in the ITT Population|Change from Baseline is calculated as the post-Baseline value minus the Baseline value. Baseline is defined as the last non-missing value obtained prior to receiving study drug. For participants who have more than one ulcer, the measurement of all ulcers were combined for analysis.|Baseline; Day 15 (Visit 5)|ITT Population. Only those participants with available data were analyzed.|||percentage of area||Standard Deviation|Mean
2555688|NCT02737722|Secondary|Mean Change From Baseline in Ulcer Area in the ITT Population|Change from Baseline is calculated as the post-Baseline value minus the Baseline value. Baseline is defined as the last non-missing value obtained prior to receiving study drug. For participants who have more than one ulcer, the measurement of all ulcers were combined for analysis.|Baseline; Day 15 (Visit 5)|ITT Population. Only those participants with available data were analyzed.|||centimeters squared (cm^2)||Standard Deviation|Mean
2555716|NCT02736890|Secondary|Static Mechanical Allodynia Testing|Mechanical allodynia is a characteristic of evoked pain in subjects with neuropathic pain. Static allodynia to mechanical stimuli will be defined as a sensation of pain evoked by the pressure of the end of a wooden stick. The end of a wooden stick will touch the affected region with enough pressure to indent the skin, for 10 seconds. Afterwards, the subject will be asked to rate the perceived pain on an 11-point NRS.|up to 12 weeks post-injection, for a total of 24 weeks from baseline|Data initially collected incorrectly, then data not collected.||||||
2555845|NCT02734810|Primary|Safety|Number of subjects reporting 1 or more adverse events|1 week||||Participants|||Count of Participants
2555689|NCT02737722|Secondary|Mean Change From Baseline in the Diabetic Foot Ulcer Wound Infection Score|Change from Baseline is calculated as the post-Baseline value minus the Baseline value. Baseline is defined as the last non-missing value obtained prior to receiving study drug. The Diabetic Foot Ulcer Wound Infection Score is a numerical scoring system comprised of 7 wound parameters. The score for each individual parameter is summed to calculate a total score, ranging from 0 (less severe infection) to 19 (more severe infection). Parameters are as follows: purulent discharge (0, absent; 3, present); non-purulent discharge (serious, sanguineous) (0, absent; 1, mild); other signs and symptoms of inflammation (erythema, induration, tenderness, pain; 0, none; 1, mild; 2, moderate; 3, severe); local warmth (relative to uninfected contralateral foot) (0, same; 1, mildly increased; 2, moderately increased; 3, severely increased).|Baseline; Day 15 (Visit 5)|ITT Population. Only those participants with available data were analyzed.|||score on a scale||Standard Deviation|Mean
2555690|NCT02737722|Secondary|Mean Change From Baseline in the Diabetic Ulcer Severity Score (DUSS)|Clinical response to bisphosphocin Nu-3 was determined by visual evaluation of ulcers, based on the Principal Investigator's judgement, following Nu-3 treatment. Ulcers were scored based on the DUSS. The following 4 parameters were scored as either 0 or 1. Palpable pedal pulses: presence, 0; absence, 1. Probing to the bone: no, 0; yes, 1. Location of ulcer: toe, 0; foot, 1. Number of ulcerations: single, 0; multiple, 1. The four parameter scores were summed to calculate a total score ranging from 0 to 4, with a higher score indicating increased severity. Baseline is defined as the last non-missing value obtained prior to receiving study drug. Change from Baseline is calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 15 (Visit 5)|ITT Population. Only those participants with available data were analyzed.|||score on a scale||Standard Deviation|Mean
2555691|NCT02737722|Primary|Number of Participants With Normal and Abnormal Cultures at Visits 2, 3, 4, and 5|The microbiological response to bisphosphocin Nu-3 based on aerobic and anaerobic culture and sensitivity was determined by measuring the reduction of pathogenic bacteria following Nu-3 treatment. Each laboratory used their own standards to decide whether the cultures were normal or abnormal.|Days 1, 2, 9, and 15 (Visits 2, 3, 4, and 5, respectively)|Intent-to-Treat (ITT) Population: all randomized participants. Only those participants with available data were analyzed. Microbiology results were not collected in the database for participants in the 0.1% cohort.|||participants|||Number
2555692|NCT02737722|Primary|Number of Participants With Treatment-related Treatment-emergent Adverse Events as Graded According to the Common Terminology Criteria for Adverse Events v4.02 (CTCAE)|The severity of each adverse event, as judged by the investigator, was graded according to the CTCAE v4.02. Treatment-emergent adverse events are defined as adverse events with onset times after dosing, or pre-existing adverse events that worsened during the study.|up to Day 15 (Visit 5)|Safety Population: all participants administered any amount of investigational product|||Participants|||Count of Participants
2555693|NCT02737631|Primary|Number of Patients That Showed Edema Based on the 5 Point Scoring Scale||8 weeks||||Participants|||Count of Participants
2555694|NCT02737631|Primary|Number of Patients That Showed Erythema Based on the 5 Point Scoring Scale||8 weeks||||Participants|||Count of Participants
2555695|NCT02737618|Primary|Number of Subjects That Showed Edema Based on the 5 Point Scoring Scale||14 days||||Participants|||Count of Participants
2555696|NCT02737618|Primary|Number of Subjects That Showed Erythema Based on 5 Point Scoring Scale||14 days||||Participants|||Count of Participants
2555697|NCT02737592|Primary|Number of Subjects With Observed Edema Based on the 5 Point Scoring Scale|Number of subjects with observed local edema by OB/GYN examination as graded on 5 point clinical scale: 0 = normal appearance no edema, 0.5 = slight edema, 1 = mild edema, 2 = moderate edema 3 = severe edema|2 weeks||||Participants|||Count of Participants
2555698|NCT02737592|Primary|Number of Subjects With Observed Local Erythema Based on 5 Point Scale|Number of subjects with observed local erythema by OB/GYN examination as graded on 5 point clinical scale: 0 = normal appearance no irritation, 0.5 = slight, irregular erythema, 1 = mild erythema, 2 = moderate erythema 3 = severe erythema|2 weeks||||Participants|||Count of Participants
2555699|NCT02737397|Post-Hoc|Efficacy of Side Effect Prevention Using the Acute Hangover Scale (Hangover Sensitive Subpopulation)|Efficacy of pain medicine + antihistamine in reducing (as compared to placebo) symptoms associated with Veisalgia. The Acute Hangover Scale (AHS) will be used to evaluate side effects on the following morning post alcohol consumption. The scale includes 9 symptom assessments each ranging from 0-10. The total score can range from 0-90. (0= no symptoms, 10 = worst symptom ever).|24 hours|A subset of participants were analyzed post-hoc that were hangover sensitive when compared to placebo.|||score on a scale||Standard Deviation|Mean
2555700|NCT02737397|Primary|Efficacy of Side Effect Prevention Using the Acute Hangover Scale|Efficacy of pain medicine + antihistamine in reducing (as compared to placebo) symptoms associated with Veisalgia. The Acute Hangover Scale (AHS) will be used to evaluate side effects on the following morning post alcohol consumption. The scale includes 9 symptom assessments each ranging from 0-10. The total score can range from 0-90. (0= no symptoms, 10 = worst symptom ever).|24 hours||||score on a scale||Standard Deviation|Mean
2555701|NCT02737163|Secondary|Number of Encounters of Inadvertent Reprogramming With Exposure to Household Devices With Electromagnetic Charge.|Here we report the number of encounter/visits during which valves were inadvertently reprogrammed due to household devices with electromagnetic charge.|14 months||||encounters|encounters||Count of Units
2555702|NCT02737163|Secondary|Number of Encounters With Increased Signs, Symptoms and Radiographic Changes Suggestive of Shunt Malfunction in Participants With Inadvertent Reprogramming of the Strata Valve Compared to Those Without Inadvertent Reprogramming.|Increased Signs, Symptoms and Radiographic Changes Suggestive of Shunt Malfunction in Participants With Inadvertent Reprogramming of the Strata Valve Compared to Those Without Inadvertent Reprogramming Assessment will be made using a family questionnaire and data sheet from clinical evaluation.|14 months|Data collected from the 15 participants with inadvertent reprogramming.|||encounters - signs of shunt malfunction|encounters with reprogramming||Number
2555703|NCT02737163|Secondary|Number of Encounters/Visits With or Without Valve Changes Due to MRI Field Strengths.|Shunt valve settings were assessed before and after MRI studies using the 1.5 Tesla (T), 3 Tesla (T) or other MRI field strengths for any valve setting changes.|14 months|Data collected from 91 encounters who underwent MRI either on the 1.5 T or the 3 T as part of their visit|||encounters|encounters||Count of Units
2555705|NCT02737072|Secondary|Percentage of Participants With CR, PR, or Stable Disease (SD) (Disease Control Rate [DCR])|DCR: percentage of participants with CR, PR, or SD using RECIST v 1.1 criteria. CR: disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR: ≥30% decrease in sum of diameter (SOD) of target lesions taking as reference baseline sum diameter. PD: ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference smallest sum of longest diameters recorded since treatment started and an absolute increase in sum diameter ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor increase to qualify for PD. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR+SD/total number of participants)*100.|Baseline through Measured Progressive Disease (Up To 12 Months)|All participants who received at least one dose of study drug.|||percentage of participants|||Number
2555706|NCT02737072|Secondary|Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|Best overall response of CR or PR was defined using RECIST v 1.1 criteria. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was defined as ≥30% decrease in sum of diameter(SOD) of target lesions taking as reference the baseline sum diameter. PD was defined as ≥20% increase in SOD of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 mm; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. Percentage of participants=(number of participants with CR+PR/total number of participants)*100.|Baseline through Measured Progressive Disease or Death (Up To 12 Months)|All participants who received at least one dose of study drug.|||percentage of participants|||Number
2555707|NCT02737072|Secondary|Number of Participants With Anti-Durvalumab Antibodies When Administered in Combination With LY2510924|Number of participants with treatment-emergent positive Anti-Durvalumab antibodies was summarized by treatment group.|Predose Cycle 1 Day 1 through 90 Day Post Treatment Follow Up (Up To 12 Months)|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2555708|NCT02737072|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC [0-∞]) of LY2510924 When Co-Administered With Durvalumab|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC [0-∞]) of LY2510924 when Co-Administered with Durvalumab|Cycle 1 Day 1: Predose, 0.5, 2, 4, 6, 8, 24-30 hours; Day 15: Predose, 0.5, 2, 4, 6, 8 hours|All participants who received at least one dose of study drug.|||nanogram*hour /milliliter (ng *h/mL)||Geometric Coefficient of Variation|Geometric Mean
2555709|NCT02737072|Primary|Maximum Tolerated Dose (MTD) of LY2510924|MTD was determined after the evaluation of Phase 1a portion of the trial. For Phase 1a, any DLT-equivalent toxicities observed in Cycle 2 and beyond were also be considered in dose escalation and determining MTD/recommended Phase 2 dose. See outcome measure number 1 for the DLT criterion.|Cycle 1 (28 Days)|All phase 1a participants who received at least one dose of study drug.|||milligram (mg)|||Number
2555710|NCT02737072|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|DLT is defined as 1 of the following adverse events(AE) reported during the Phase 1a DLT observation period,if considered to be definitely,probably,or possibly related to either study regimen by the investigator;and fulfills any 1 of the following criterion using(NCI)CTCAE version(v)4.03:Grade4 immune-related AE,Grade4 non-laboratory AE,any CTCAE Grade ≥3 QT prolongation AE,≥Grade3 colitis or noninfectious pneumonitis irrespective of duration,Grade3 immune-related AE(excluding colitis,QT prolongation,or pneumonitis) that does not downgrade to Grade2 within 3 days after onset of event despite optimal medical management including systemic corticosteroids,or does not downgrade to ≤Grade 1 or baseline within 14 days,Grade2 pneumonitis that does not resolve to ≤Grade 1 within 3 days of the initiation of maximal supportive care,including corticosteroid therapy,Grade3 toxicity lasting an extended time despite optimal supportive care and there were also laboratory abnormalities criterion.|Cycle 1 (28 Days)|All participants who received at least one of dose of study drug.|||Participants|||Count of Participants
2555711|NCT02736955|Secondary|Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ)|"Participant's perspective of his/her satisfaction with valbenazine treatment. The PSQ is based on a 5-point scale (range: 1=very satisfied to 5=very dissatisfied). A clinical response was defined as a PSQ score equal to 1 or 2."|Baseline and Weeks 12, 24, 36, 48, and 60|Safety analysis set: includes all participants who were enrolled in the study and received study drug, with the following two exclusions: (a) participants who withdrew from the study and returned all previously dispensed study drug with all doses present, and (b) participants who had no post-baseline data collected.|||Participants|||Count of Participants
2555712|NCT02736955|Secondary|Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale|"Clinician's perspective of the participant's overall severity of TD symptoms. The CGI-TD-Severity is based on a 7-point scale (range: 1= Normal, not at all ill to 7= Among the most extremely ill patient). A clinical response was defined as a CGI-TD-S score equal to 1 or 2."|Baseline and Weeks 12, 24, 36, 48, and 60|Safety analysis set: includes all participants who were enrolled in the study and received study drug, with the following two exclusions: (a) participants who withdrew from the study and returned all previously dispensed study drug with all doses present, and (b) participants who had no post-baseline data collected.|||Participants|||Count of Participants
2555713|NCT02736955|Primary|Number of Participants Monitored for Long-term Safety of Valbenazine|Incidence of adverse events and monitoring of vital signs, clinical laboratory values, and electrocardiograms. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared.|60 weeks||||Participants|||Count of Participants
2555714|NCT02736890|Secondary|Patient-generated Index (PGI)|PGI measures activity affected by pain. Full score is 0 to 10000, with higher score indicating better function|up to 12 weeks post-injection, for a total of 24 weeks from baseline|only those who completed crossover were included|||score on a scale||Standard Deviation|Mean
2555717|NCT02736890|Secondary|International Basic Pain Dataset - Pain Affecting Sleep|The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting sleep subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes.|up to 12 weeks post-injection, for a total of 24 weeks from baseline|only those who completed crossover were included|||units on a scale||Standard Deviation|Mean
2555718|NCT02736890|Secondary|International Basic Pain Dataset - Pain Affecting Mood|The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting mood subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes.|up to 12 weeks post-injection, for a total of 24 weeks from baseline|only those who completed crossover were included|||units on a scale||Standard Deviation|Mean
2555719|NCT02736890|Secondary|International Basic Pain Dataset - Pain Affecting Day-to-day Activities|The International Basic Pain Dataset is an assessment tool which includes several components including: location of pain, temporal qualities of the pain, type of pain, pain interference measures of activity, sleep, and mood. It has been shown to be valid in an interview/self -report format. The pain affecting day-to-day activities subset of the dataset is scored is from 0 to 10, with higher score indicating less favorable outcomes.|up to 12 weeks post-injection, for a total of 24 weeks from baseline|only those who completed crossover were included|||units on a scale||Standard Deviation|Mean
2555720|NCT02736890|Secondary|7-Point Guy/Farrar Patient Global Impression of Change (PGIC)|"Mean change from baseline. Participants are asked Taking into account your pain level and how it affects your life, are you feeling better, the same or worse than when you started treatment? and then to quantify the magnitude of the change. with the 7-Point guy Farrar which measures the global treatment effect from with scale from 0 to 6, higher score indicates worse outcomes."|up to 12 weeks post-injection, for a total of 24 weeks from baseline|only those who completed crossover were included|||score on a scale||Standard Deviation|Mean
2555721|NCT02736890|Primary|Numeric Pain Rating Scale (NPRS)|Participant rated pain intensity from 0-10, with higher score indicating more pain|up to 12 weeks post-injection, for a total of 24 weeks from baseline|only those who completed crossover were included|||score on a scale||Standard Deviation|Mean
2555722|NCT02736825|Secondary|Number of Participants With Overall Aesthetic Improvement as Assessed by CGAIS at Day 365|Overall aesthetic improvement was assessed by the clinician using a CGAIS. The CGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).|Day 365|No data was collected because the study was terminated at 180 days.||||||
2555723|NCT02736825|Secondary|Number of Participants With Overall Aesthetic Improvement as Assessed by CGAIS at Day 180|Overall aesthetic improvement was assessed by the clinician using a CGAIS. The CGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).|Day 180|The ITT population consisted of all participants in SES for whom primary efficacy variable was available. Participants who were evaluable for this measure at given time period were included.|||Participants|||Number
2555724|NCT02736825|Secondary|Number of Participants With Overall Aesthetic Improvement as Assessed by Clinician Global Aesthetic Improvement Scale (CGAIS) at Day 90|Overall aesthetic improvement was assessed by the clinician using a CGAIS. The CGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).|Day 90|The ITT population consisted of all participants in SES for whom primary efficacy variable was available.|||Participants|||Number
2555725|NCT02736825|Secondary|Number of Participants With Overall Aesthetic Improvement as Assessed by SGAIS at Day 365|Overall aesthetic improvement was assessed by participants using SGAIS. Each participant completed a SGAIS. The SGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).|Day 365|No data was collected because the study was terminated at 180 days.||||||
2555726|NCT02736825|Secondary|Number of Participants With Overall Aesthetic Improvement as Assessed by SGAIS at Day 180|Overall aesthetic improvement was assessed by participants using SGAIS. Each participant completed a SGAIS. The SGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).|Day 180|The ITT population consisted of all participants in SES for whom primary efficacy variable was available. Participants who were evaluable for this measure at given time period were included.|||Participants|||Number
2555727|NCT02736825|Secondary|Number of Participants With Overall Aesthetic Improvement as Assessed by Subject Global Aesthetic Improvement Scale (SGAIS) at Day 90|Overall aesthetic improvement was assessed by participants using SGAIS. Each participant completed a SGAIS. The SGAIS was 5-point scale (1-5), where: 1 (very much improved); 2 (much improved); 3 (improved); 4 (no change); 5 (worse).|Day 90|The ITT population consisted of all participants in SES for whom primary efficacy variable was available.|||Participants|||Number
2555728|NCT02736825|Secondary|Mean Pain Scores to Assess Participant's Treatment Related Comfort Level Based on Numeric Rating Scale (NRS)|Participant's treatment-related pain scores were obtained using a validated 11-point NRS with 0: no pain; 5: moderate pain; and 10: worst possible pain. Pain scores were obtained following each region treated (submandibular/submental and cheeks) and for each transducer used during treatment. Average pain score was calculated for each arm by adding all the scores of all participants in each arm to obtain the mean NRS score.|Baseline|The SES was the subset of all participants who were exposed to study treatment at least once.|||Score on a scale||Standard Deviation|Mean
2555729|NCT02736825|Secondary|Mean Treatment Times|Mean treatment time was based on a comparison of average time to complete treatment using each transducer type. The time to complete the study treatment for each group was recorded on the system treatment logs as treatment start time (time treatment started on the Ulthera system) and stop time (time treatment ended on the Ulthera system).|Baseline|The SES was the subset of all participants who were exposed to study treatment at least once.|||Minutes||Standard Deviation|Mean
2555836|NCT02734940|Secondary|Ionotropic Requirement|Total duration of ionotropic requirement (hours)|Total duration ionotropes intraoperatively (hours); total amount ionotropes required from time of admission to ICU postoperatively to discharge from hospital (hours), (maximum 30 days)|The study was terminated because of lack of enrollment. No data was collected.||||||
2555730|NCT02736825|Secondary|Number of Participants With Some Level of Improvement and Satisfaction on Day 90|"Participants completed a patient satisfaction questionnaire (PSQ) at the 90-day visit. The PSQ has 5 improvement and satisfaction categories ranging from worse to much improved and dissatisfied' to very satisfied."|Day 90|The ITT population consisted of all participants in the SES for whom the primary efficacy variable was available. Participants who were evaluable for this measure at given time period were included.|||Participants|||Number
2555731|NCT02736825|Secondary|Percent Change From Baseline in Volume as Assessed by Quantificare 3D Imaging System at Day 365|Additional images were obtained using a 3D digital photo system. QuantifiCare 3D imaging was used to assess the volumetric changes. Four views (Face, UnderRight, UnderLeft, and Neck) were compared for each participant.|Day 365|No data was collected because the study was terminated at 180 days.||||||
2555732|NCT02736825|Secondary|Percent Change From Baseline in Volume as Assessed by Quantificare 3D Imaging System at Day 180|Additional images were obtained using a 3D digital photo system. QuantifiCare 3D imaging was used to assess the volumetric changes. Four views (Face, UnderRight, UnderLeft, and Neck) were compared for each participant.|Day 180|The ITT population consisted of all participants in the SES for whom the primary efficacy variable was available.|||Percent change||Standard Deviation|Mean
2555733|NCT02736825|Secondary|Percent Change From Baseline in Volume as Assessed by Quantificare 3 D Imaging System at Day 90|Additional images were obtained using a 3D digital photo system. QuantifiCare 3D imaging was used to assess the volumetric changes. Four views (Face, UnderRight, UnderLeft, and Neck) were compared for each participant.|Day 90|The ITT population consisted of all participants in the SES for whom the primary efficacy variable was available. Participants who were evaluable for this measure at given time period were included.|||Percent change||Standard Deviation|Mean
2555734|NCT02736825|Secondary|Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 365|Improvement was determined by qualitative assessment of photographs by a masked physician.|Day 365|No data was collected because the study was terminated at 180 days.||||||
2555735|NCT02736825|Secondary|Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 180|Improvement was determined by qualitative assessment of photographs by a masked physician.|Day 180|The ITT population consisted of all participants in the SES for whom the primary efficacy variable was available. Participants who were evaluable for this measure at given time period were included.|||Participants|||Number
2555736|NCT02736825|Secondary|Number of Participants Who Showed Improvement in Overall Lifting and Tightening of Skin at Day 90|Improvement was determined by qualitative assessment of photographs by a masked physician.|Day 90|The ITT population consisted of all participants in the SES for whom the primary efficacy variable was available.|||Participants|||Number
2555737|NCT02736825|Secondary|Number of Participants Who Achieved >=20 mm^2 Reduction in Submental Area at Day 365|Participant response was defined as >=20 mm^2 reduction in 2D submental area from baseline. Submandibular and Submental quantitative measurements were calculated comparing participants using prototype 2 simulines versus standard transducers. The standard 2D photographic images were obtained. Utilizing the lateral profile view of pre-and 180-day post treatment photos of each participant, quantitative results were calculated by using 5 evenly spaced points on the neck. Area was calculated between each of the 5 points and then sum of the 5 calculations was the total area of the region of interest. The delta area between the pre-and post-treatment area of the chin and neck determined the amount of tissue lift in the area.|Day 365|No data was collected because the study was terminated at 180 days.||||||
2555738|NCT02736825|Secondary|Number of Participants Who Achieved >=20 mm^2 Reduction in Submental Area at Day 180|Participant response was defined as >=20 mm^2 reduction in 2D submental area from baseline. Submandibular and Submental quantitative measurements were calculated comparing participants using prototype 2 simulines versus standard transducers. The standard 2D photographic images were obtained. Utilizing the lateral profile view of pre-and 180-day post treatment photos of each participant, quantitative results were calculated by using 5 evenly spaced points on the neck. Area was calculated between each of the 5 points and then sum of the 5 calculations was the total area of the region of interest. The delta area between the pre-and post-treatment area of the chin and neck determined the amount of tissue lift in the area.|Day 180|No data was collected because the study was terminated at 180 days.||||||
2555739|NCT02736825|Primary|Number of Participants Who Achieved Greater Than or Equal to (>=) 20 mm^2 Reduction in Submental Area at Day 90|Participant response was defined as >=20 mm^2 reduction in 2D submental area from baseline. Submandibular and Submental quantitative measurements were calculated comparing participants using prototype 2 simulines versus standard transducers. The standard 2D photographic images were obtained. Utilizing the lateral profile view of pre-and 90-day post treatment photos of each participant, quantitative results were calculated by using 5 evenly spaced points on the neck. Area was calculated between each of the 5 points and then sum of the 5 calculations was the total area of the region of interest. The delta area between the pre-and post-treatment area of the chin and neck determined the amount of tissue lift in the area.|Day 90|The intent-to-treat (ITT) population consisted of all participants in the SES for whom the primary efficacy variable was available.|||Participants|||Number
2555740|NCT02736721|Primary|Time to Loss of Previous MR|Time to loss of previous MR was defined as the interval between the first day of treatment in the study and the first day of loss of previous MR. MR was assessed using BCR-ABL transcript levels measured by RT-PCR from peripheral blood.|Up to approximately 7 years|Analysis population included all enrolled participants.|||years||95% Confidence Interval|Median
2555741|NCT02736721|Primary|Number of Participants With Molecular Response (MR)|MR was assessed using breakpoint cluster region - Abelson (BCR-ABL) proto-oncogene transcript levels measured by RT-PCR from peripheral blood. Number of participants with BCR-ABL/ABL ratio less than or equal to 10 (%) was reported.|Up to approximately 7 years|Analysis population included all enrolled participants.|||participants|||Number
2555742|NCT02736721|Primary|Time to Loss of Previous CyR|Time to loss of previous CyR was defined as the interval between the first day of treatment in the study and the first day of loss of previous CyR. CyR is based on the prevalence of Ph+ bone marrow cells in metaphase. Major CyR was categorized as either CCyR or PCyR. CCyR was achieved when there was absence of detectable Ph+ bone marrow cells and PCyR was achieved when 1 to 34% of bone marrow cells were Ph+.|Up to approximately 7 years|Analysis population included all enrolled participants.|||years||95% Confidence Interval|Median
2555743|NCT02736721|Primary|Number of Participants With Major Cytogenetic Response (CyR)|CyR was based on the prevalence of Philadelphia chromosome-positive (Ph+) bone marrow cells in metaphase determined from reverse transcriptase polymerase chain reaction (RT-PCR). Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was absence of detectable Ph+ bone marrow cells and PCyR was achieved when 1 to 34 percent (%) of bone marrow cells were Ph+.|Up to approximately 7 years|Analysis population included all enrolled participants.|||participants|||Number
2555744|NCT02736721|Primary|Time to Loss of Previous Hematologic Response|Time to loss of previous hematologic response was defined as the interval between the first day of treatment in the study and the first day of loss of previous hematologic response during elapsed time of study. Hematologic response was considered to be achieved if participants met all of the following criteria: normalization of white blood cells count to <10*10^9/L with normal differentiation, normalization of platelet count at <450*10^9/L, and disappearance of all signs and symptoms of the disease. This response had to be confirmed at least 4 weeks after the first measure and beyond that.|Up to approximately 7 years|Analysis population included all enrolled participants.|||months||95% Confidence Interval|Median
2555745|NCT02736721|Primary|Number of Participants With Complete Hematologic Response|Hematologic response was considered to be achieved if participants met all of the following criteria: normalization of white blood cells count to less than (<) 10*10^9 per liter (/L) with normal differentiation, normalization of platelet count at <450*10^9/L, and disappearance of all signs and symptoms of the disease. This response had to be confirmed at least 4 weeks after the first measure and beyond that.|Up to approximately 7 years|Analysis population included all enrolled participants.|||participants|||Number
2555746|NCT02736578|Secondary|Toxicity (≥ Grade 2)|"Toxicity was assessed as the number of grade 2 or greater adverse events [Common Terminology Criteria for Adverse Events (CTCAE) version 4.03] determined to be clinically-significant and definitely-, probably-, or possibly-related to cetuximab-IRDye 800CW.~The outcome is reported as the number of treatment-related adverse events ≥ grade 2 without dispersion, by dose level."|Up to 30 days||||Adverse events|||Number
2555747|NCT02736578|Secondary|Signal-to-Noise Ratio (SNR) by In Vivo Photoacoustic Imaging (PAI)|Photoacoustic imaging (PAI) was to be used to evaluate tumor and normal margin tissues (waste tissue) immediately peri-operatively (in vivo) and prior to pathological evaluation. The signal-to-noise ratio (SNR) as measured in dB of the tumor was to be calculated in the tumor specimens for comparison to surrounding normal tissue. The outcome would be expressed as the mean of the ratios, with standard deviation, and data used to qualitatively confirm the findings with Cetuximab-IRDye 800CW fluorescent imaging.|up to 5 days|The in vivo photoacoustic imaging (PAI) component of this study was not IRB-approved, and this part of the study was not conducted.||||||
2555748|NCT02736578|Secondary|Signal-to-Noise Ratio (SNR) by Ex Vivo Photoacoustic Imaging (PAI)|Photoacoustics were assessed as the signal-to-noise ratio (SNR), a unit-less number, as observed for tumor vs surrounding tissue using an ultrasound device. The value observed for tumor tissue is considered signal, and the value for normal tissue is considered noise. The more the ratio is greater than 1 reflects the more that the tumor tissue reflects an ultrasound signal compared to normal tissue. The outcome is expressed as the ratio of mean SNR signal for tumor tissue to normal tissue, without dispersion.|up to 5 days|Tissue sampling and labeling can be imprecise. Due to small numbers and the expression of the outcome value as a mean of ratios, the analysis was conducted on all evaluable participants as a single cohort. Data were not obtained for all participants. Dispersion was not and can not be determined for the outcome, a ratio (ratio of means).|||ratio|||Number
2555749|NCT02736578|Secondary|Cetuximab-IRDye800 Tumor Detection in Lymph Nodes|Cetuximab-IRDye800 (50 mg or 100 mg) florescence intensity was assessed in excised lymph nodes (ie, ex vivo) that were histologically-determined to be normal or tumor-bearing. Fluorescent intensity was measured in the image for each lymph using close-field fluorescence imaging and expressed as counts per pixel. The outcome is expressed for each tissue as the dose-independent mean fluorescent intensity (MFI) for the cohort. The outcome is expressed as the mean MFI with standard deviation.|up to 14 days|The relationship of the number of participants to number of analyzed lymph nodes (tumor-bearing or not) is not 1:1, & tissue sampling & labeling are imprecise. Participants could contribute none or multiple normal and tumor-bearing lymph node for analysis. Data were not obtained for all participants.|||counts per pixel|Lymph nodes|Standard Error|Mean
2555750|NCT02736578|Secondary|Sensitivity and Specificity of Ex Vivo Fluorescent Imaging|"Sensitivity is the ability of a test to correctly identify patients with the condition, ie, how well Cetuximab-IRDye800 fluorescent imaging detects true-positive patients. Sensitivity is defined as [TP/(TP+FN)], where TP=true-positive, and FN=false-negative. The outcome is a % without dispersion. A higher % means a greater probability that an imaging target identified as cancerous is confirmed by histology to be cancerous, and a lower % means reduced confidence in that result.~Specificity is the ability of a test to correctly identify patients who do not have the condition, ie, how well Cetuximab-IRDye800 fluorescent imaging detects true-negative patients. Specificity is defined as [TN/(TN+FP)], where TN=true-negative, and FP=false-positive. The outcome is a % without dispersion. A higher % means a greater probability that an imaging target identified as non-cancerous is confirmed by histology to be non-cancerous, and a lower % means reduced confidence in that result."|up to 14 days|Outcome results for sensitivity and specificity of fluorescent imaging were available by dose, and compiled across both doses. Tissue sampling and labeling can be imprecise, and there may not have been residual tissue after standard-of-care pathological analysis. Data were not obtained for all participants.|||percentage of lymph nodes|Lymph nodes||Number
2555751|NCT02736578|Secondary|Effect of Cetuximab-IRDye800 Dose on Fluorescence Intensity|Cetuximab-IRDye800 (50 mg or 100 mg) florescence intensity was assessed in normal pancreatic tissue; pancreatitis tissue; and pancreatic tumor tissue prepared as formalin-fixed paraffin-embedded (FFPE) blocks. Fluorescent intensity was measured in the image for each tissue, and expressed as counts per pixel. The outcome is expressed for each tissue as the dose-independent mean fluorescent intensity (MFI) for the cohort. The outcome is expressed as a mean with standard deviation, by dose.|up to 14 days|Tissue sampling and labeling can be imprecise, and there may not have been residual tissue after standard-of-care pathological analysis. Data were not obtained for all participants.|||counts per pixel||Standard Deviation|Mean
2555837|NCT02734940|Secondary|Bowel Function|Bowel Function|Will determine each day postoperatively if patient has had a bowel movement, measured in days (maximum 30 days)|The study was terminated because of lack of enrollment. No data was collected.||||||
2555752|NCT02736578|Secondary|Cetuximab-IRDye800 Labeling Intensity in Tumor and Non-Tumor Tissues (Ex Vivo)|Cetuximab-IRDye800 (50 mg or 100 mg) florescence intensity was assessed in normal pancreatic tissue; pancreatitis tissue; and pancreatic tumor tissue prepared as formalin-fixed paraffin-embedded (FFPE) blocks. Fluorescent intensity was measured in the image for each tissue, and expressed as counts per pixel. The outcome is expressed for each tissue as the dose-independent mean counts/pixel for the cohort. The outcome is expressed as the mean counts/pixel with standard deviation.|up to 14 days|Due to small numbers and the expression of the outcome value as a mean of ratios, the analysis was conducted on all evaluable participants as a single cohort in order to reduce variance/dispersion.|||counts per pixel||Standard Deviation|Mean
2555753|NCT02736578|Primary|Peri-operative Cetuximab-IRDye800 Fluorescent Imaging, Both Doses|"Cetuximab-IRDye800 (50 mg or 100 mg) was administered pre-operatively, and the uptake of the dye was assessed by observed fluorescence intra-operatively (ie, in vivo) and post-operatively (ex vivo, or back table), in tumorous (tumor or tumor-bearing lymph nodes) or normal (non-tumorous) tissues. Collectively, intra-operative and immediately post-operative are considered peri-operative. The outcome tumor-to-background ratio (TBR) is measured as the mean of the ratios observed between tumor and normal tissue for the participants, and the outcome is expressed as the mean with standard deviation."|up to 5 days|Due to small numbers and the expression of the outcome value as a mean of ratios, the analysis was conducted on all evaluable participants as a single cohort in order to reduce variance/dispersion.|||ratio||Standard Deviation|Mean
2555754|NCT02736188|Secondary|Change From Baseline in Percent Predicted Total Force in Knee Extensors Over Time|The percent predicted total force value of lower extremity muscle strength in the knee extensors was determined based on reference equations adjusting for age, gender, height, and weight. Analyzed using a repeated measure GEE model, which includes the baseline value as a covariate.|Baseline, Weeks 8, 16, 24, and 48|Full Analysis Set: all participants in parent study UX001-CL301 (NCT02377921) with a UX001-CL302 baseline measurement and at least one post-baseline measurement in UX001-CL302.|||percent of predicted total force (kgf)||95% Confidence Interval|Least Squares Mean
2555755|NCT02736188|Secondary|Change From Baseline in Total Force in Knee Extensors Over Time|Hand held dynamometry testing was used to measure strength. The maximum voluntary isometric contraction against a dynamometer was used to measure bilateral strength in the following muscle groups: shoulder abductors, wrist extensors and knee extensors. Specialized dynamometers for the measurement of grip and key pinch strength were also used. The total force (in kgf) for each was recorded. Bilateral total force was defined as the average of the right and left force (measured in kgf). Analyzed using a repeated measure GEE model, which includes the baseline value as a covariate.|Baseline, Weeks 8, 16, 24, and 48|Full Analysis Set: all participants in parent study UX001-CL301 (NCT02377921) with a UX001-CL302 baseline measurement and at least one post-baseline measurement in UX001-CL302.|||kgf||95% Confidence Interval|Least Squares Mean
2555756|NCT02736188|Secondary|Change From Baseline in Percent Predicted Meters Walked in 6MWT Over Time|The total distance walked (meters) in a 6-minute period was measured, and the percent predicted distance based on normative data for age and gender was estimated. Predicted 6MWT distance (meters) = 868.8 - (2.99 x Age) - (74.7 x Sex), where age is baseline age in years, and sex = 0 for males, and 1 for females. Analyzed using a repeated measure GEE model, which includes the baseline value as a covariate.|Baseline, Weeks 8, 16, 24, and 48|Full Analysis Set: all participants in parent study UX001-CL301 (NCT02377921) with a UX001-CL302 baseline measurement and at least one post-baseline measurement in UX001-CL302.|||percent of predicted distance||95% Confidence Interval|Least Squares Mean
2555757|NCT02736188|Secondary|Change From Baseline in Meters Walked in 6MWT Over Time|The total distance walked (meters) in a 6-minute period was measured. Analyzed using a repeated measure GEE model, which includes the baseline value as a covariate.|Baseline, Weeks 8, 16, 24, and 48|Full Analysis Set: all participants in parent study UX001-CL301 (NCT02377921) with a UX001-CL302 baseline measurement and at least one post-baseline measurement in UX001-CL302.|||meters||95% Confidence Interval|Least Squares Mean
2555758|NCT02736188|Secondary|Change From Baseline in Number of Lifts in the 30-Second Weighted Arm Lift Test Over Time|Upper extremity function was assessed using a weighted arm lift test performed bilaterally. The number of times the participant can raise a 1 kg weight above the head in a 30-second period was recorded. Analyzed using a repeated measure GEE model, which includes the baseline value as a covariate.|Baseline, Weeks 8, 16, 24, and 48|Full Analysis Set: all participants in parent study UX001-CL301 (NCT02377921) with a UX001-CL302 baseline measurement and at least one post-baseline measurement in UX001-CL302.|||lifts||95% Confidence Interval|Least Squares Mean
2555759|NCT02736188|Secondary|Change From Baseline in the Number of Stands in the Sit-to-Stand Test Over Time|Lower extremity function was assessed using a sit-to-stand test. The number of times the participant can rise from a seated to a standing position in a 30-second period was recorded. Analyzed using a repeated measure GEE model, which includes the baseline value as a covariate.|Baseline, Weeks 8, 16, 24, and 48|Full Analysis Set: all participants in parent study UX001-CL301 (NCT02377921) with a UX001-CL302 baseline measurement and at least one post-baseline measurement in UX001-CL302.|||stands||95% Confidence Interval|Least Squares Mean
2555760|NCT02736188|Secondary|Change From Baseline in HHD Lower Extremity Composite (LEC) Score Over Time|Hand held dynamometry testing was used to measure strength. The maximum voluntary isometric contraction against a dynamometer was used to measure bilateral strength in the following muscle groups: shoulder abductors, wrist extensors and knee extensors. Specialized dynamometers for the measurement of grip and key pinch strength were also used. The total force (in kgf) for each was recorded. The LEC is derived from the sum of the average of the right and left total force (measured in kgf). Analyzed using a repeated measure GEE model, which includes the baseline value as a covariate.|Baseline, Weeks 8, 16, 24, and 48|Full Analysis Set: all participants in parent study UX001-CL301 (NCT02377921) with a UX001-CL302 baseline measurement and at least one post-baseline measurement in UX001-CL302.|||kgf||95% Confidence Interval|Least Squares Mean
2555761|NCT02736188|Secondary|Change From Baseline on the GNEM-FAS Upper Extremity Domain Score Over Time|GNEM-FAS Expanded Version Upper Extremity subscale score has 9 items and ranges from 0 to 36 with higher scores representing more skilled, independent use of the arms during functional activity performance. Analyzed using a repeated measure GEE model, which includes the baseline value as a covariate.|Baseline, Weeks 8, 16, 24, 48|Full Analysis Set: all participants in parent study UX001-CL301 (NCT02377921) with a UX001-CL302 baseline measurement and at least one post-baseline measurement in UX001-CL302.|||score on a scale||95% Confidence Interval|Least Squares Mean
2555762|NCT02736188|Secondary|Change From Baseline in the GNEM-FAS Expanded Version Mobility Domain Score Over Time|GNEM-FAS Expanded Version Mobility subscale score has 13 items and ranges from 0 to 52 with higher scores representing greater mobility. Analyzed using a repeated measure GEE model, which includes the baseline value as a covariate.|Baseline, Weeks 8, 16, 24, 48|Full Analysis Set: all participants in parent study UX001-CL301 (NCT02377921) with a UX001-CL302 baseline measurement and at least one post-baseline measurement in UX001-CL302.|||score on a scale||95% Confidence Interval|Least Squares Mean
2555763|NCT02736188|Primary|Change From Baseline in HHD UEC Score Over Time|Hand held dynamometry testing was used to measure strength. The maximum voluntary isometric contraction against a dynamometer was used to measure bilateral strength in the following muscle groups: shoulder abductors, wrist extensors and knee extensors. Specialized dynamometers for the measurement of grip and key pinch strength were also used. The total force (in kgf) for each was recorded. The UEC is derived from the sum of the average of the right and left total force (measured in kgf). Analyzed using a repeated measure generalized estimation equation (GEE) model, which includes the baseline value as a covariate.|Baseline, Weeks 8, 16, 24, 48|Full Analysis Set: all participants in parent study UX001-CL301 (NCT02377921) with a UX001-CL302 baseline measurement and at least one post-baseline measurement in UX001-CL302.|||kgf||95% Confidence Interval|Least Squares Mean
2555764|NCT02736188|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs (SAEs), and Discontinuations Due to AEs|An AE was defined as any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. An SAE or serious suspected adverse reaction is an AE or suspected adverse reaction that at any dose, in the view of either the Investigator or Ultragenyx, results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or disability (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect. TEAEs were defined as any AE that occurred after the first dose of study drug. The severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03: grade1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening, grade 5=death.|From first dose of study drug through the end of treatment plus 30 days (+5 days). Mean (SD) duration of treatment was 256.3 (101.54) days.|Safety Analysis Set: all participants who received at least one dose of study drug in UX001-CL302.|||Participants|||Count of Participants
2555765|NCT02736175|Primary|Absence of Ocular Pain|Absence of pain (i.e., score of '0') in the study eye at Day 8|Day 8|ITT LOCF (last observation carried forward)|||percentage of total participants|||Number
2555766|NCT02736175|Primary|Absence of Anterior Chamber Inflammation|Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14|Day 14|ITT LOCF (last observation carried forward)|||percentage of total participants|||Number
2555767|NCT02735980|Secondary|Change From Baseline on the Average Symptom Burden Index (ASBI)|ABSI was the mean score for the six major lung cancer symptoms (appetite, fatigue, cough, dyspnea, hemoptysis and pain), each scored between 0 (for best outcome) to 100 (for worst outcome).|Baseline up to 9 months|All participants in Cohort 1 and Cohort 2. Cohort 3 was added by protocol addendum and data were not collected with non missing baseline and post baseline scores.|||units on a scale||Standard Deviation|Mean
2555768|NCT02735980|Secondary|Change From Baseline in Lung Cancer Symptom Scale Score (LCSS)|LCSS is a 9-item questionnaire, six measuring major symptoms for lung malignancies (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items related to total symptomatic distress, activity status and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-mm lines. The LCSS total score was defined as the mean of the 9 items of the scale, each scored between 0 (for best outcome) to 100 (for worst outcome).|Baseline up to 9 months|All participants in Cohort 1 and Cohort 2. Cohort 3 was added by protocol addendum and data were not collected with non missing baseline and post baseline scores.|||units on a scale||Standard Deviation|Mean
2555769|NCT02735980|Secondary|Overall Survival (OS)|OS defined as from randomization date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.|Baseline up to 28 months|All randomized participants. 8 participants were censored from Cohort 1, 5 participants were censored from Cohort 2 and 4 participants censored from Cohort 3.|||months||95% Confidence Interval|Median
2555770|NCT02735980|Secondary|Duration of Response (DoR)|DoR the time from the date of an objective response until Progressive Disease (PD): was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.|Date of CR or PR to Date of Disease Progression or Death Due to Any Cause up to 9 months|Analysis was not performed due to only 3 responders in Cohort 1, no in Cohort 2 or 3. Individual data for Cohort 1 is presented.|||days|||Number
2555771|NCT02735980|Secondary|Progression-Free Survival (PFS)|PFS defined as the from randomization date to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.|Baseline to Disease Progression or Death (up to 9 months)|All randomized participants. 4 participants were censored from Prexasertib Cohort 1 and 1 participant from Prexasertib Cohort 3.|||months||95% Confidence Interval|Median
2555838|NCT02734940|Secondary|Ionotropic Requirement|Total amount ionotropes required|Total amount ionotropes required intraoperatively (mcg); total amount ionotropes required from time of admission to ICU postoperatively to discharge from hospital (maximum 30 days)|The study was terminated because of lack of enrollment. No data was collected.||||||
2555839|NCT02734940|Secondary|Delirium Scores|CAM-ICU scores at above time points|24, 48 and 72 hours|The study was terminated because of lack of enrollment. No data was collected.||||||
2555772|NCT02735980|Secondary|Disease Control Rate: Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD)|Disease control rate (DCR) is defined as the percentage of participants achieving a best overall response of CR, PR, or SD as determined by RECIST 1.1. CR is defined as a disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10 mm and normalization of tumor marker results; PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters; SD is defined as neither sufficient shrinking to qualify as PR nor sufficient increase to qualify for PD.|Baseline through Disease Progression or Death from Any Cause to 28 months|All randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2555773|NCT02735980|Secondary|Pharmacokinetics: Area Under the Concentration Curve of Prexasertib|Pharmacokinetics: Area Under the Concentration Curve of Prexasertib|Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime|All participants in Part A1 that received at least 1 dose of study drug and had evaluable PK data.|||mg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2555774|NCT02735980|Secondary|Pharmacokinetics(PK): Maximum Concentration of Prexasertib Cohort 3 (40 mg/m^2, Protocol Addenda)|Pharmacokinetics(PK): Maximum Concentration of Prexasertib|Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime|Al randomized participants with at least 1 dose of study drug, received 40 mg/m^2 and had evaluable PK parameters.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2555775|NCT02735980|Secondary|Pharmacokinetics(PK): Maximum Concentration (Cmax) of Prexasertib Cohort 1 and Cohort 2|Pharmacokinetics(PK): Maximum Concentration of Prexasertib. The same dose was administered to Cohort 1 and Cohort 2 and were combined for analysis.|Cycle 1,3, 5, and 7: Day 1, Day 2 and Day 3- Prior to start of infusion, end of infusion plus 10 minutes, Day 8: anytime|All randomized participants who received at least 1 dose of study drug and had evaluable PK parameters. Cohort 1 and Cohort 2 received the same dose and were combined per protocol.|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2555776|NCT02735980|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])|ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions|Baseline to 10 months|All randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2555777|NCT02735915|Secondary|Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs).|pIMDs assessed includes AEs that were autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related pIMDs= pIMDs assessed by the investigator as related to the vaccination.|From Dose 1 of re-vaccination (Month 120) until study end (Month 134).|The analysis was performed on the Total vaccinated cohort for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study.|||Participants|||Count of Participants
2555778|NCT02735915|Secondary|Number of Subjects With Any, Related and Fatal SAEs.|SAEs assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Dose 1 of re-vaccination (Month 120) until study end (Month 134).|The analysis was performed on the Total vaccinated cohort for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study.|||Participants|||Count of Participants
2555779|NCT02735915|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) According to the Medical Dictionary for Regulatory Activities (MedDRA) Classification in All Subjects.|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0-29) after each vaccination in the current study.|The analysis was performed on the Total vaccinated cohort for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study.|||Participants|||Count of Participants
2555780|NCT02735915|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms included: fatigue, gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache, myalgia, shivering and temperature [higher than or equal to (≥) 37.5 degrees Celsius (°C) for axillary, oral or tympanic route] and ≥38.0°C for rectal route. Grade 3 fatigue, gastrointestinal symptoms, headache, myalgia, shivering = symptoms that prevented normal activity. Grade 3 temperature = defined as fever higher than (>) 39.0°C, regardless of the route used.|Within 7 days (Days 0-6) after each vaccination and across doses, in the current study.|The analysis was performed on the Total vaccinated cohort for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study, who had their symptom sheets filled in.|||Participants|||Count of Participants
2555781|NCT02735915|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms.|Assessed solicited local symptoms included: pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, prevented normal every day activities. Grade 3 redness/swelling = symptoms spreading beyond a surface of (>) 100 millimeters (mm).|Within 7 days (Days 0-6) after each vaccination and across doses, in the current study.|The analysis was performed on the Total vaccinated cohort for re-vaccination course, which included all subjects with at least one dose of GSK1437173A vaccine in the current ZOSTER-060 (NCT02735915) study, who had their symptom sheets filled in.|||Participants|||Count of Participants
2555782|NCT02735915|Secondary|Frequencies of Antigen-specific CD4 (2+) T-cells, Post Re-vaccination Course.|Antigen specific CD4 (2+)T cells were determined by means of ICS and expressed in T-cells/million cells.|At 1 month post each re-vaccination dose (i.e. Month 121 and Month 123) and at 1 year post last re-vaccination dose (i.e., Month 134).|The analysis was performed on the ATP cohort analysis of immunogenicity after re-vaccination, which included subjects who complied with the protocol criteria, have received at least one dose from the re-vaccination schedule and had immunogenicity results available at the timepoints considered.|||CD4 T-cells/million cells||Inter-Quartile Range|Median
2555783|NCT02735915|Secondary|Anti-gE Specific Antibody (Ab) Concentrations|Anti-gE antibody concentrations were determined by ELISA in all subjects, presented as GMCs and expressed in mIU/mL.|At 1 month post each re-vaccination dose (i.e. Month 121 and Month 123) and at 1 year post last re-vaccination dose (i.e., Month 134).|The analysis was performed on the ATP cohort analysis of immunogenicity after re-vaccination, which included subjects who complied with the protocol criteria, have received at least one dose from the re-vaccination schedule and had immunogenicity results available at the timepoints considered.|||mIU/mL||95% Confidence Interval|Geometric Mean
2555784|NCT02735915|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) Related to Study Participation or to a Concurrent GSK Medication/Vaccine (Including GSK1437173A Administered During the Zoster-003 [NCT00434577] Study).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Between Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).|The analysis was performed on the Total enrolled cohort which included all subjects enrolled into the current study [ZOSTER-060 (NCT02735915)].|||Participants|||Count of Participants
2555785|NCT02735915|Secondary|Frequencies of Antigen-specific CD4 (2+) T-cells by Each Age Category|Antigen specific CD4 (2+) T-cells as determined by means of ICS and expressed in T-cells/million cells, by each age category (60-69 YOA and ≥ 70 YOA at the time of initial vaccination).|At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).|The analysis for persistence at month 108 and 120 was performed on the ATP cohort analysis of immunogenicity at Years 9 and 10, which included subjects who complied with the protocol criteria and had immunogenicity results available at the timepoints considered.|||CD4 T-cells/million cells||Inter-Quartile Range|Median
2555786|NCT02735915|Secondary|Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations by Each Age Category|Anti-gE Ab concentrations as determined by ELISA by each age category (60-69 years of age [YOA] and ≥70 YOA at the time of initial vaccination).Antibody concentrations were presented as GMCs and expressed in mIU/mL.|At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).|The analysis for persistence at month 108 and 120 was performed on the ATP cohort analysis of immunogenicity at Years 9 and 10, which included subjects who complied with the protocol criteria and had immunogenicity results available at the time points considered.|||mIU/mL||95% Confidence Interval|Geometric Mean
2555787|NCT02735915|Primary|Frequencies of gE (Glycoprotein)-Specific Cluster of Differentiation (CD4) (2+) T-cells.|gE specific CD4 (2+)T-cells expressing at least 2 activation markers among IFN-γ, IL-2, TNF-α and CD40L were determined by means of ICS and expressed in T-cells/million cells.|At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).|The analysis for persistence at month 120 was performed on the ATP cohort analysis of immunogenicity at Year 10, which included subjects who complied with the protocol criteria and had immunogenicity results available up to the timepoint considered.|||CD4 T-cells/million cells||Inter-Quartile Range|Median
2555788|NCT02735915|Primary|Frequencies of gE (Glycoprotein)-Specific Cluster of Differentiation (CD4) (2+) T-cells.|gE specific CD4 (2+) T-cells expressing at least 2 activation markers among IFN-γ, IL-2, TNF-α and CD40L, were determined by means of Intracellular Cytokine Staining (ICS) and expressed in T-cells/million cells.|At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).|The analysis for persistence at month 108 was performed on the ATP cohort analysis of immunogenicity at Year 9, which included subjects who complied with the protocol criteria and had immunogenicity results available up to the timepoint considered.|||CD4 T-cells/million cells||Inter-Quartile Range|Median
2555789|NCT02735915|Primary|Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations|Anti-gE Ab concentrations were determined by ELISA, presented as GMCs and expressed in mIU/mL.|At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).|The analysis for persistence at month 120 was performed on the ATP cohort analysis of immunogenicity at Year 10, which included subjects who complied with the protocol criteria and had immunogenicity results available up to the timepoint considered.|||mIU/mL||95% Confidence Interval|Geometric Mean
2555790|NCT02735915|Primary|Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations|Anti-glycoprotein E (gE) Ab concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micro international units per milliliter (mIU/mL).|At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).|The analysis for persistence at month 108 was performed on the According-to-protocol (ATP) cohort analysis of immunogenicity at Year 9, which included subjects who complied with the protocol criteria and had immunogenicity results available up to the timepoint considered.|||mIU/mL||95% Confidence Interval|Geometric Mean
2555791|NCT02735551|Primary|Number of Participants Reporting Ongoing Use and Satisfaction|Proportion of Long Acting Reversible Contraception (LARC) uptake among women, by group assignment. This will be evaluated based on participants' self-reported ongoing use and satisfaction by group assignment on the 3-month questionnaire after the initial visit. 3 months following placement of LARC device, initiation of short acting method, and those in the control group, participants will complete a questionnaire in order to assess ongoing use and satisfaction of their contraceptive method. This will be measured on the 3-month questionnaire.|3 months|No participants enrolled in both the Control Group or the LARC Group. All 3 participants analyzed met the criteria specified for this analysis.|||Participants|||Count of Participants
2555840|NCT02734940|Secondary|ICU Length of Stay||Days from arrival to ICU to transfer to step down or floor level of care (maximum of 30 days)|The study was terminated because of lack of enrollment. No data was collected.||||||
2555841|NCT02734940|Secondary|Extubation|Time from arrival to ICU to extubation|Hours from arrival to ICU to endotracheal extubation (maximum of 12 hours)|The study was terminated because of lack of enrollment. No data was collected.||||||
2555792|NCT02735421|Primary|Total Atrophic Acne Scar Count Per Half-face|The scars were counted according to their size defined in two categories using 2-millimeter (mm) and 4-mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars greater than (>) 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.|Week 24|Intent to treat (ITT) population|||atrophic acne scars||Standard Deviation|Mean
2555793|NCT02735382|Secondary|Change in Global Staff Satisfaction With the Referral Intervention|"In order to assess clinician and staff satisfaction with the eReferral and paper-based referral systems, a single-item The steps I need to take to address my patients' tobacco use are efficient and well designed was administered to healthcare system clinical staff. The response format was 1 = Strongly disagree; 2 = Disagree; 3 = Mildly disagree; 4 = Feel neutral; 5 = Mildly agree; 6 = Agree; 7 = Strongly agree. Higher scores indicate greater satisfaction with the assigned intervention (EHR-based vs Fax-based referral systems). The item is not part of any existing validated scale and was created for purposes of the project; this item was selected from a larger set of items and determined to be the most appropriate measure of overall staff satisfaction."|Satisfaction measures will be surveyed at baseline and at 6 months and reported as a single change score|Clinic staff in the study clinics.|||units on a scale||Standard Deviation|Mean
2555794|NCT02735382|Secondary|Number of Participants Self-reporting Smoking Abstinence|To evaluate smoking abstinence rates of tobacco users who were referred to and accepted services from the WTQL, comparing those who were referred via an EHR-based referral system vs. those referred via a manual paper fax referral system.|7-day point prevalence smoking outcomes at 4-months after participant registration with the WI Tobacco Quit Line.|Participant data were derived from Quit Line records.|||Participants|||Count of Participants
2555795|NCT02735382|Secondary|Number of Participants Meeting Criteria for Quality Referral|To evaluate the rates of quality referrals of tobacco users visiting primary care clinics to the tobacco quitline. Quality referrals are defined as ones that result in individuals who enroll in and receive tobacco quit line services.|Rates come from cumulative data collected over the course of 6 months.|Participant data were derived from Quit Line records.|||Participants|||Count of Participants
2555796|NCT02735382|Primary|Number of Participants Referred|EHR-based vs. Fax-based rates of referral of adult tobacco users visiting primary care clinics to the tobacco quitline. The rate of referral will be determined by the ratio of total referrals to total smokers identified in the clinic's EHR over a period of 6 months of study observation.|Rates come from cumulative data collected over the course of 6 months.|Participant data were derived from EHR records.|||Participants|||Count of Participants
2555797|NCT02735200|Primary|Level of Serum 25 OHD Level Pre-treatment and Post Treatment|Patients had analysis of serum 25 OHD level pre and post treatment, to check if treatment with Topical Vitamin D made any difference.|baseline and 5 months||||ng/mL||Standard Deviation|Mean
2555798|NCT02735187|Other Pre-specified|Thermal Comfort|Thermal comfort will be measured by questionaire: How comfortable was this temperature on your skin?|week 12|Safety set|||Count of Participants|||Number
2555799|NCT02735187|Other Pre-specified|Device Deficiencies|The number of device deficiencies was collected throughout the study|week 0-12|Safety set|||Number of device deficiencies|||Number
2555800|NCT02735187|Other Pre-specified|Adverse Device Effects|Adverse device effects collected during the study conduct.|week 0-16|Safety set|||Number of adverse device effects|||Number
2555801|NCT02735187|Other Pre-specified|Adverse Events (Serious and Non-serious)|Adverse Events (serious and non-serious) collected during the study conduct.|week 0-16|Safety set|||Number of adverse events|||Number
2555802|NCT02735187|Other Pre-specified|Hyperpigmentation of Treated Skin Areas Exposed to Blue Light and Control Area Exposed to Daivonex- Evaluation by Mexameter|Lesional tanning was measured objectively with a measurement device (Mexameter). The Mexameter delivers a two digit number for the brownish color of the skin (range 0-99). 0 = no tanning and 99 = maximal tanning.|week 2-16|Safety Set|||units on a scale||Standard Deviation|Mean
2555803|NCT02735187|Secondary|Patient Satisfaction (Week 12)|Patient satisfaction will be measured by questionnaire using the System usability score (SUS). The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. The higher the score the better the patient satisfaction the better the outcome. The lower the score the worse the patient satisfaction the worse the outcome.|week 12|Full Analysis set|||units on a scale||Standard Deviation|Mean
2555804|NCT02735187|Secondary|Lesional Erythema Measured by Mexameter Measured at End of Treatment.|Lesional erythema was measured objectively with a measurement device (Mexameter). The Mexameter delivers a two digit number for the redness of the skin (range 0-99). 0 = no redness and 99 = maximal redness.|week 12|Full Analysis set|||units on a scale||Standard Deviation|Mean
2555805|NCT02735187|Secondary|Change From Baseline in Patient Self-assessment of Severity of Psoriasis of the Blue Light Treated Area (Group 15) Compared to the VitaminD Treated (Control) Area at Week 12 (VAS Scale).|Patient Rating of severity of Psoriasis Plaques on 0-10 cm Visual Analogue Scale (VAS) scale. VAS = 0 corresponds to no symptoms of Psoriasis, VAS = 10 corresponds to most severe symptoms of Psoriasis.|week 12|Full Analysis set|||units on a scale||Standard Deviation|Mean
2555806|NCT02735187|Secondary|Change From Baseline in Patient Self-assessment of Severity of Psoriasis of the Blue Light Treated Area (Group 30) Compared to the VitaminD Treated (Control) Area at Week 12 (VAS Scale).|Patient Rating of severity of Psoriasis Plaques on a 0-10 cm Visual Analogue Scale (VAS) scale. VAS = 0 cm corresponds to no pain,, VAS = 10 cm corresponds to maximal imaginable pain.|week 12|Full Analysis set|||units on a scale||Standard Deviation|Mean
2555842|NCT02734940|Secondary|Patient Satisfaction|Patient Satisfaction with pain management in first 24 hours post extubation - as measured by acute pain service nurses (who will be blinded)|24 hours, 48 hours, 72 hours, 7 days, 30 days|The study was terminated because of lack of enrollment. No data was collected.||||||
2555807|NCT02735187|Secondary|Change From Baseline (Visit 2) of the Local PSI of the Blue Light Treated Area (Group 15) as Compared to the VitaminD Treated (Control) Area at End of Treatment (Week 12).|The local Psoriasis severity index (LPSI) was adapted from the well known PASI. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas (0-4 each). A total severity score was calculated as the sum of the three symptom ratings (range 0-12). The measure reported is the change in LPSI at end of treatment versus baseline. A negative change indicates an improvement of the LPSI.|week 12|Full Analysis Set|||units on a scale||Standard Deviation|Mean
2555808|NCT02735187|Primary|Change From Baseline (Visit 2) of the Local PSI of the Blue Light Treated Area (Group 30) as Compared to the VitaminD Treated Area (Control) at End of Treatment (Week 12).|The local Psoriasis severity index (LPSI) was adapted from the well known PASI. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas (0-4). A total severity score was calculated as the sum of the three symptom ratings (range 0-12). The measure reported is the change in LPSI at end of treatment versus baseline. A negative change indicates an improvement of the LPSI.|week 12|Full Analysis Set (FAS)|||units on a scale||Standard Deviation|Mean
2555809|NCT02735096|Secondary|Analog Visual Scale for the Perceived Frequency of Stimulation Pulses|A patient's assessment of the speed of pulses to quantify perceptual difference in the pulse frequencies of the feedback on the palatal surface.|July 2016 - October 2016 (~ 4 months)|This test process was not performed for patients with vestibular dysfunction as it is such a tedious process that it is not practical for a patient with dizziness to complete.||||||
2555810|NCT02735096|Secondary|Dynamic Gait Index|A subject's gait is evaluated by a physical therapist when no device is worn and when alternative sensory feedback of head movement is presented to the patient using the device. 7 walking exercises were administrated for each DGI test, with a score in the range of 0 - 3 (0 for severely impaired and 3 for normal gait) for each exercise, and a total score in the range of 0 - 21 for each test.|July 2016 - October 2016 (~ 4 months)|One patient did not show any symptoms during clinical visits, and her DGIs were excluded for comparison.|||score on a scale||Standard Deviation|Mean
2555811|NCT02735096|Secondary|Perceived Intensity Level|The perceived Intensity level (from 0 to 5) as judged by a patient in response to pulsed stimuli applied on the palatal surface after adjustment of device settings for that patient. 1 - barely perceptible, 2 - weak, 3 - good, 4 - strong, 5 - painful.|July 2016 - October 2016 (~ 4 months)|Even though 1 patient did not show any symptoms during clinical visits, all 4 patients each had a device custom made and tested for perceived intensity levels.|||units on a scale||Standard Deviation|Mean
2555812|NCT02735096|Primary|Equilibrium Score|Equilibrium scores for each trial for each condition from Sensory Organization Test (EquiTest). Conditions: 1-6; with or without using EquiCue intraoral balance aid. Equilibrium scores were generated from the EquiTest CDP (computerized dynamic posturography) platform to assess standing balance of a patient ranging from 0 (all falls) to 100 (perfect balance with no sway), with higher scores indicating better balance performance. An equilibrium score of 70 and above is considered normal.|July 2016 - October 2016 (~ 4 months)|One patient did not have any symptoms during clinical visits, and she did not finish the three test sessions for balance and DGI. Her results were excluded for comparison. The remaining participants included one male and two females.|||score on a scale||Standard Deviation|Mean
2555813|NCT02735044|Secondary|Percentage of Participants With Any Hyperglycemia With Ketosis at Month 12|Hyperglycemia with ketosis was defined as SMPG >=252 mg/dL (14 mmol/L) with accompanying self-measured blood ketones >=1.5 mmol/L.|Month 12|Analysis was performed on the safety population.|||percentage of participants|||Number
2555814|NCT02735044|Secondary|Percentage of Participants With at Least One Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Symptomatic, Probable Symptomatic, Asymptomatic Hypoglycemia, Pseudo-hypoglycemia and Severe and/or Confirmed Hypoglycemia) at Month 12|Severe hypoglycemia: an event in which the child/adolescent having altered mental status and cannot assist in their care, is semiconscious or unconscious, or in coma ± convulsions and may require parenteral therapy (glucagon or glucose). Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (3.9 mmol/L). Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration <=70 mg/dL. Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia were not accompanied by plasma glucose determination but was presumably caused by a plasma glucose concentration <=70 mg/dL. Pseudo-hypoglycemia:an event with any of the typical symptoms of hypoglycaemia with plasma glucose concentration >70 mg/dL.|Month 12|Analysis was performed on the safety population which included all randomized participants who actually received who received at least 1 dose or part of a dose of IMP, and was analyzed according to treatment received.|||percentage of participants|||Number
2555815|NCT02735044|Secondary|Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point|8-point SMPG profiles were measured for following 8 time points at Baseline and Month 6: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime.|Baseline to Month 6|Analysis was performed on ITT population. Here, ‘number analyzed’ = participants with available data for each specified category.|||mmol/L||Standard Deviation|Mean
2555816|NCT02735044|Secondary|Change From Baseline in Variability of 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles at Month 6|8-point SMPG profiles were measured at the following 8 points: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Variability was assessed by the coefficient of variation (standard deviation divided by mean) calculated over the 8-point SMPG. Analysis was performed using a ANCOVA model including the fixed categorical effects of treatment group, randomization strata of screening HbA1c (<8.5%; >=8.5%) and randomization strata of age at screening (<12 years, >=12 years).|Baseline, Month 6|Analysis was performed on ITT population. Here, 'Overall number of participants analyzed' signified number of participants with available data for the outcome measure.|||percentage of mean variability||Standard Error|Least Squares Mean
2555843|NCT02734940|Secondary|Postoperative Opioid Consumption|Opioid consumption measured in oral morphine equivalents|24 hours, 48 hours, 72 hours|The study was terminated because of lack of enrollment. No data was collected.||||||
2555817|NCT02735044|Secondary|Change From Baseline in 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles to Month 6|8-point SMPG profiles were measured at the following 8 points: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Analysis was performed using a ANCOVA model including the fixed categorical effects of treatment group, randomization strata of screening HbA1c (<8.5%; >=8.5%), randomization strata of age at screening (<12 years, >=12 years) and the baseline 24-hour average 8-point profile SMPG.|Baseline to Month 6|Analysis was performed on ITT population. Here, 'Overall number of participants analyzed' signified number of participants with available data for the outcome measure.|||mmol/L||Standard Error|Least Squares Mean
2555818|NCT02735044|Secondary|Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) Without Any Episode of Severe and/or Documented (SMPG <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period|Participants without any available HbA1c assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (<8.5%; >=8.5%) and randomization strata of age at screening (<12 years, >=12 years).|upto Month 6|Analysis was performed on ITT population.|||percentage of participants|||Number
2555819|NCT02735044|Secondary|Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) at Month 6|Participants without any available FPG assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (<8.5%; >=8.5%) and randomization strata of age at screening (<12 years, >=12 years).|Month 6|Analysis was performed on ITT population.|||percentage of participants|||Number
2555820|NCT02735044|Secondary|Percentage of Participants With HbA1c Values of <7.5% Without Any Episode of Severe and/or Documented Self-Monitored Plasma Glucose ([SMPG] <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period|Participants without any available HbA1c assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (<8.5%; >=8.5%) and randomization strata of age at screening (<12 years, >=12 years).|upto Month 6|Analysis was performed on ITT population.|||percentage of participants|||Number
2555821|NCT02735044|Secondary|Percentage of Participants With HbA1c Values of <7.5% at Month 6|Participants without any available HbA1c assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (<8.5%; >=8.5%) and randomization strata of age at screening (<12 years, >=12 years).|Month 6|Analysis was performed on ITT population.|||percentage of participants|||Number
2555822|NCT02735044|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) to Month 6|Change in FPG was calculated by subtracting baseline value from Month 6 value. Adjusted LS means and SE were obtained using ANCOVA after multiple imputation to address missing data in the main 6 month randomized period.|Baseline to Month 6|Analysis was performed on ITT population. Here, 'Overall number of participants analyzed' signified number of participants with available data for the outcome measure.|||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
2555823|NCT02735044|Primary|Change From Baseline in HbA1c to Month 6|Change in HbA1c was calculated by subtracting baseline value from Month 6 value. Adjusted least-square (LS) means and standard errors (SE) were obtained using analysis of covariance (ANCOVA) after multiple imputations of missing data using post-baseline HbA1c data available on the main 6-month randomized period.|Baseline to Month 6|Analysis was performed on intent-to-treat (ITT) population that included all randomized participants, regardless of whether the treatment kit was used, and was analyzed according to the allocated treatment group. Here, ‘Overall number of participants analyzed’ signified number of participants with available data for the outcome measure.|||Percentage of HbA1c||Standard Error|Least Squares Mean
2555824|NCT02734953|Secondary|Change in RV Stroke Work Index|Difference between baseline (t=0) and post-intervention (t=2h)|2 hours||||g*m/m2||Full Range|Mean
2555825|NCT02734953|Secondary|Change in Stroke Volume|Difference between baseline (t=0) and post-intervention (t=2h)|2 hours||||mL||Full Range|Mean
2555826|NCT02734953|Secondary|Change in Right Ventricular (RV) Power|Difference between baseline (t=0) and post-intervention (t=2h)|2 hours||||J/s||Full Range|Mean
2555827|NCT02734953|Secondary|Change in Rate Pressure Product|Difference between baseline (t=0) and post-intervention (t=2h)|2 hours||||mmHg*beat/min||Full Range|Mean
2555828|NCT02734953|Secondary|Change in Heart Rate|Difference between baseline (t=0) and post-intervention (t=2h)|2 hours||||bpm||Full Range|Mean
2555829|NCT02734953|Secondary|Change in Mean Arterial Pressure|Difference between baseline (t=0) and post-intervention (t=2h).|2 hours||||mmHg||Full Range|Mean
2555830|NCT02734953|Secondary|Change in O2 Requirements|Number of patients that required more or less oxygen by nasal prongs during the course of the study.|2 hours||||participants|||Number
2555831|NCT02734953|Secondary|Change in Modified Borg Dyspnea Scale|"The Modified Borg Dyspnea scale measures patient's subjective analysis of dyspnea from 0 (nothing at all) to 10 (maximal) during the 6MWD test with the highest value recorded and difference calculated between baseline (t=0) and post-intervention (t=2h)."|2 hours||||units on a scale||Full Range|Mean
2555832|NCT02734953|Secondary|Change in O2 Saturations||2 hours||||% O2 Sat||Full Range|Mean
2555833|NCT02734953|Secondary|Change in 6 Minute Walk Distance (6MWD)|Difference (in distance walked between 2 set points over 6 minutes) at baseline (t=0) to post-intervention (t=2h).|2 hours||||m||Full Range|Mean
2555834|NCT02734953|Secondary|Change in CardioMems Cardiac Output|Difference between baseline (t=0) and post-intervention (t=2h)|2 hours||||L/min||Full Range|Mean
2555835|NCT02734953|Primary|Difference in Ambulatory 6 Minute Walk Distance (6MWD) Pulmonary Artery (PA) Pressures (Systolic, Diastolic, Mean) Between the Post-intervention (iNO+) and Pre-intervention (iNO-) Condition as Measured by the CardioMems Device|Difference between baseline (t=0) and post-intervention (t=2h)|2 hours||||mmHg||Full Range|Mean
2555846|NCT02734693|Secondary|Change From Baseline at Day 15 in Permanent Product Measure of Performance (PERMP)-Attempted and Correct Problems Scores Obtained From the 7 Assessments Collected Over the 12-hour Classroom Day (12-24-hours Postdose)|TThe Permanent Product Measure of Performance (PERMP) is a math test consisting of 400 problems. Both attempted problems and correct problems are assessed. Subjects are to complete as many problems as possible in 10 minutes. Performance is measured by the number of math problems attempted and the number of math problems correctly completed. The minimum possible score is 0. The highest possible score is 400, with higher scores mean higher performance and less severe ADHD symptoms.|Baseline to Day 15|intent to treat population, placebo and dasotraline 4mg. The dasotraline 6mg arm was discontinued after 20 subjects were enrolled and no data were collected for this Arm/Group|||units on a scale||Standard Error|Least Squares Mean
2555847|NCT02734693|Secondary|Change From Baseline at Day 15 in Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Deportment Subscale Score Obtained From the 7 Assessments Collected Across the 12-hour Classroom Day (12 to 24 Hours Postdose)|The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The Deportment Subscale scores for the SKAMP are obtained by summing the values of Items 5-8 in the assessment. The range of SKAMP Deportment Subscale score is 0-24, with higher values represent a worse outcome.|Baseline to Day 15|intent to treat population, placebo and dasotraline 4mg. The dasotraline 6mg arm was discontinued after 20 subjects were enrolled and no data were collected for this Arm/Group|||units on a scale||Standard Error|Least Squares Mean
2555848|NCT02734693|Secondary|Change From Baseline at Day 15 in Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)Attention Subscale Score Obtained From the 7 Assessments Collected Across the 12-hour Classroom Day (12 to 24 Hours Postdose)|The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The Attention Subscale scores for the SKAMP are obtained by summing the values of Items 1-4 in the assessment. The range of SKAMP Attention Subscale score is 0-24, with higher values represent a worse outcome.|Baseline to Day 15|intent to treat population, placebo and dasotraline 4mg. The dasotraline 6mg arm was discontinued after 20 subjects were enrolled and no data were collected for this Arm/Group|||units on a scale||Standard Error|Least Squares Mean
2555849|NCT02734693|Primary|Change From Baseline at Day 15 in , ADHD Symptoms as Measured by Mean Swanson,Kotkin,Agler,M-Flynn, Pelham Rating Scale(SKAMP)-Combined Score Obtained From an Average of the 7 Assessments Collected Across the 12-hour Classroom Day(12 to 24 Hours Postdose)|The Swanson, Kotkin, Agler, M-Flynn, Pelham Rating Scale (SKAMP) scale is a 13-item independent observer rating of subject impairment of classroom observed behaviors. Each item is rated on a 7-point impairment scale (0 = normal to 6 = maximal impairment). The combined scores for the SKAMP are obtained by summing the values of all 13 items in the assessment. The range of SKAMP combined score is 0-78, with higher values represent a worse outcome.|Baseline to Day 15|intent to treat population, placebo and dasotraline 4mg. The dasotraline 6mg arm was discontinued after 20 subjects were enrolled and no data were collected for this Arm/Group|||Units on a scale||Standard Error|Least Squares Mean
2555850|NCT02734498|Primary|Catatonia on the Bush- Francis Scale (BFCRS) - Pre|Repetitive evaluation by the Bush- Francis Scale (BFCRS) - To assess excitement, immobility, mutism, staring, posturing/catalepsy, grimacing, echopraxia, stereotypy, mannerisms, verbigeration, rigidity, negativism, waxy flexibility, withdrawal, impulsivity, automatic obedience, mitgehen, gegenhalten, ambitendency, grasp reflex, preservation, combativeness and automatic abnormality. Contains 23 items rated using a scale of 0-3. Total Score 0-69. Higher scores denote worse outcomes.|1 day post first ECT treatment|Only two participants enrolled because study ended. Both randomized to same group.|||units on a scale||Standard Deviation|Mean
2555851|NCT02734498|Secondary|Cognitive Side Effects on Montreal Cognitive Assessment (MoCA)|Repetitive evaluation by the Montreal Cognitive Assessment (MoCA)- To evaluate possible cognitive side effects.|30 days|Data not collected||||||
2555852|NCT02734498|Secondary|Depression on the Hamilton Depression Scale|Repetitive evaluation by the Hamilton depression scale - To measure efficacy of ECT|30 days|Data not collected||||||
2555853|NCT02734498|Primary|Catatonia on the Bush- Francis Scale (BFCRS) - Pre|Repetitive evaluation by the Bush- Francis Scale (BFCRS) - To assess excitement, immobility, mutism, staring, posturing/catalepsy, grimacing, echopraxia, stereotypy, mannerisms, verbigeration, rigidity, negativism, waxy flexibility, withdrawal, impulsivity, automatic obedience, mitgehen, gegenhalten, ambitendency, grasp reflex, preservation, combativeness and automatic abnormality. Contains 23 items rated using a scale of 0-3. Total Score 0-69. Higher scores denote worse outcomes.|Prior first ECT treatment|Only two participants enrolled because study ended. Both randomized to same group.|||units on a scale||Standard Deviation|Mean
2555854|NCT02734433|Secondary|Number and Percentage of Participants With Treatment-related TEAEs by Preferred Term (Safety Analysis Set)||Baseline up to 18 months|Adverse events were assessed in the Safety Analysis Set.|||Participants|||Count of Participants
2555855|NCT02734433|Secondary|Number and Percentage of Participants With Common Treatment-emergent Adverse Events (TEAEs) (≥20%) Classified by Preferred Term (Safety Analysis Set)||Baseline up to 18 months|Adverse events were assessed in the Safety Analysis Set.|||Participants|||Count of Participants
2555856|NCT02734433|Secondary|A Summary of Plasma ZAAD-1006a Pharmacokinetic Parameter (MR Cmax) Following Oral Doses of Pexidartinib|Metabolite to parent drug ratio of maximum pexidartinib concentration (MR Cmax) was assessed.|Cycle 1, Day 1 and Day 15 at predose, 0.5h, 1h, 2h, 4h, and 8h postdose|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||metabolite to parent drug ratio||Standard Deviation|Mean
2555857|NCT02734433|Secondary|A Summary of Plasma ZAAD-1006a Pharmacokinetic Parameter (MR AUC[0-8h]) Following Oral Doses of Pexidartinib|Metabolite to parent drug ratio of area under the curve from 0-8 h (MR AUC[0-8h]) was assessed.|Cycle 1, Day 1 and Day 15 at predose, 0.5h, 1h, 2h, 4h, and 8h postdose|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||metabolite to parent drug ratio||Standard Deviation|Mean
2555858|NCT02734433|Secondary|A Summary of Plasma ZAAD-1006a Pharmacokinetic Parameter (Tmax) Following Oral Doses of Pexidartinib|Time at maximum pexidartinib concentration (Tmax) was assessed.|Cycle 1, Day 1 and Day 15 at predose, 0.5h, 1h, 2h, 4h, and 8h postdose|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||hours||Standard Deviation|Mean
2555859|NCT02734433|Secondary|A Summary of Plasma ZAAD-1006a Pharmacokinetic Parameter (Cmax) Following Oral Doses of Pexidartinib|Maximum concentration (Cmax) of pexidartinib was assessed.|Cycle 1, Day 1 and Day 15 at predose, 0.5h, 1h, 2h, 4h, and 8h postdose|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||ng/mL||Standard Deviation|Mean
2555860|NCT02734433|Secondary|A Summary of Plasma ZAAD-1006a Pharmacokinetic Parameter (AUC[0-8h]) Following Oral Doses of Pexidartinib|Area under the curve from 0 to 8 hours (AUC[0-8h]) was assessed.|Cycle 1, Day 1 and Day 15 at predose, 0.5h, 1h, 2h, 4h, and 8h postdose|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||ng*h/mL||Standard Deviation|Mean
2555861|NCT02734433|Secondary|A Summary of Pexidartinib Pharmacokinetic Parameter (R[Cmax]) by Cohort Following Oral Doses of Pexidartinib|Accumulation ratio of maximum concentration of pexidartinib (R[Cmax]) was assessed.|Cycle 1, Day 15 at predose, 0.5h, 1h, 2h, 4h, and 8h postdose|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||accumulation ratio of Cmax||Standard Deviation|Mean
2555862|NCT02734433|Secondary|A Summary of Pexidartinib Pharmacokinetic Parameter (R[AUC]) by Cohort Following Oral Doses of Pexidartinib|Accumulation ratio of area under the curve (R[AUC]) was assessed.|Cycle 1, Day 15 at predose, 0.5h, 1h, 2h, 4h, and 8h postdose|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||accumulation ratio of AUC||Standard Deviation|Mean
2555863|NCT02734433|Secondary|A Summary of Pexidartinib Pharmacokinetic Parameter (Tmax) by Cohort and Day Following Oral Doses of Pexidartinib|Time at maximum pexidartinib concentration (Tmax) was assessed.|Cycle 1, Day 1 and Day 15 at predose, 0.5h, 1h, 2h, 4h, and 8h postdose|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||hours||Standard Deviation|Mean
2555864|NCT02734433|Secondary|A Summary of Pexidartinib Pharmacokinetic Parameter (AUC[0-8h]) by Cohort and Day Following Oral Doses of Pexidartinib|Area under the curve from 0 to 8 hours (AUC[0-8h]) was assessed.|Cycle 1, Day 1 and Day 15 at predose, 0.5h, 1h, 2h, 4h, and 8h postdose|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||ng*h/mL||Standard Deviation|Mean
2555865|NCT02734433|Secondary|A Summary of Pexidartinib Pharmacokinetic Parameter (Cmax) by Cohort and Day Following Oral Doses of Pexidartinib|Maximum concentration (Cmax) of pexidartinib was assessed.|Cycle 1, Day 1 and Day 15 at predose, 0.5h, 1h, 2h, 4h, and 8h postdose|Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.|||ng/mL||Standard Deviation|Mean
2555866|NCT02734433|Secondary|Duration of Response or Duration of Stable Disease Following Oral Doses of Pexidartinib (Efficacy Analysis Set)||Day 1 through Day 28 after last dose (within 18 months)|Duration of response or duration of stable disease was assessed in the Efficacy Analysis Set.|||months||Standard Deviation|Mean
2555867|NCT02734433|Primary|Overall Response Based on RECIST V1.1 Following Oral Doses of Pexidartinib (Efficacy Analysis Set)|For the assessment of tumor response, participants were classified into the best of the following tumor response categories by RECIST v1.1: complete response (CR), disappearance of all target lesions and normalization of tumor marker level; partial response (PR), at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; stable disease (SD); neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study; progressive disease (PD), at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm; or not evaluable (NE) for analysis. Objective response rate was defined as CR or PR and disease control rate was defined as CR, PR, or SD.|Day 1 through Day 28 after last dose (within 18 months)|Best overall response was assessed in the Efficacy Analysis Set.|||Number of participants|||Number
2555868|NCT02734355|Secondary|Exercise Tolerance|six-minute walk distance in meters|7 days||||m||Standard Deviation|Mean
2555869|NCT02734355|Secondary|Quality of Life|The average of eight scores of 36-Item Short Form Health Survey (SF-36). In every case all of eight scores (which ranges from 0 to 100) was summarized, then the sum was divided by 8. Thus the outcome also ranges from 0 (worse outcome) to 100 (better outcome).|7 days||||units on a scale||Standard Deviation|Mean
2555870|NCT02734355|Primary|Pulmonary Circulation Pressure Load|Right ventricular systolic pressure (RVSP, mm Hg).|7 days||||mm Hg||Standard Deviation|Mean
2555871|NCT02734355|Primary|Left Atrial Pressure Load|Mean left atrial pressure (MLAP, mm Hg).|7 days||||mm Hg||Standard Deviation|Mean
2555872|NCT02734355|Primary|Left Atrial Dimensions|Left atrial antero-posterior diameter (LAD, cm)|7 days||||cm||Standard Deviation|Mean
2555873|NCT02734355|Primary|Left Atrial Contractility|Left atrial active emptying fraction (LAAEF, %)|7 days||||percentage of LA maximum volume||Standard Deviation|Mean
2555874|NCT02734355|Primary|Retrograde Flow in Pulmonary Veins|Velocity time integral of right superior pulmonary vein flow during left atrial systole (VTI Ar, cm)|7 days||||cm||Standard Deviation|Mean
2555875|NCT02734355|Primary|Pulmonary Vein Flow Emptying|S/D ratio of right superior pulmonary vein flow|7 days||||ratio||Standard Deviation|Mean
2555876|NCT02734355|Primary|Isovolumic Relaxation|Left ventricular isovolumic relaxation time (IVRT, ms).|7 days||||ms||Standard Deviation|Mean
2555877|NCT02734355|Primary|Diastolic Function|E/A ratio of transmitral flow|7 days||||ratio||Standard Deviation|Mean
2555878|NCT02734355|Primary|Left Atrial Reservoir Function|Velocity time integral of transmitral flow (VTITMF, cm) during the whole diastole.|7 days||||cm||Standard Deviation|Mean
2555879|NCT02734355|Primary|Active Emptying of Left Atrium|Velocity time integral of transmitral flow during atrial contraction (VTI A, cm).|7 days||||cm||Standard Deviation|Mean
2555880|NCT02734355|Primary|Passive Emptying of Left Atrium|Velocity time integral of transmitral flow during left ventricle early filling phase (VTI E, cm).|7 days||||cm||Standard Deviation|Mean
2555881|NCT02734238|Primary|Body Composition at the End of Each Study Phase|Height was measured using a stadiometer. Weight was measured using a calibrated digital scale. Body composition was determined using dual-energy X-ray absorptiometry. These data were used to calculate fat-free body mass, fat mass, and total body tissue mass.|end of each study phase: Day 11 for Phase 1, Day 39 for Phase 2, up to Day 85 for Phase 3||||kilograms||95% Confidence Interval|Least Squares Mean
2555963|NCT02732912|Other Pre-specified|Use of Intervention|The SleepSure questionnaire asks about use of the intervention on the night before.|At end of first night in hospital (first morning in hospital)||||Participants|||Count of Participants
2555882|NCT02734212|Secondary|Social Self-Efficacy|The Social Self-Efficacy subscale of Sherer's Self-Efficacy Scale was used to measure participant's beliefs or expectations about their abilities with regards to social interactions/relationships. A total score is calculated by summing the responses on the items (range= 5-30). Higher score indicate greater social self-efficacy.|Baseline and Post Treatment (~3 1/2 months)|Number analyzed in the rows differ from overall because 5 participants in the ESS-P and 10 in the eTAU did not complete the post-treatment assessment|||units on a scale||Standard Deviation|Mean
2555883|NCT02734212|Secondary|General Self-Efficacy|The General Self-Efficacy subscale of Sherer's Self-Efficacy Scale was used to measure participant's general beliefs or expectations about their abilities. A total score is calculated by summing the responses on the items (range= 17-85). Higher score indicate greater general self-efficacy.|Baseline and Post Treatment (~3 1/2 months)|Number analyzed in the rows differ from overall because 5 participants in the ESS-P and 10 in the eTAU did not complete the post-treatment assessment|||units on a scale||Standard Deviation|Mean
2555884|NCT02734212|Primary|Internalized Stigma of Mental Illness Inventory (Internalized Stigma)|The Internalized Stigma of Mental Illness Inventory was used to measure of internalized or self-stigma. A total score is calculated by taking an average of the responses on the items (range=1 to 4). Higher total scores indicate greater internalized stigma.|Basline and Post Treatment (~3 1/2 months)|Number analyzed in the rows differ from overall because 5 participants in the ESS-P and 10 in the eTAU did not complete the post-treatment assessment|||units on a scale||Standard Deviation|Mean
2555885|NCT02734056|Primary|Anxiety|The questions will be scored and a composite score will be determined. The scale is the numeric rating score, from 0-10, where 0 represents no anxiety and 10 represents the worst anxiety. Unit of measure is score on a scale.|1 hour||||NRS||Standard Deviation|Mean
2555886|NCT02733991|Secondary|Mean Time Spent of Sensor Glucose Values Within Range and Including 70-180 mg/dL.||6 months|2 participants in the control arm did not have data.|||minutes per day||Standard Deviation|Mean
2555887|NCT02733991|Secondary|Mean Time Spent of Sensor Glucose Values Below or Equal 55 mg/dL.||6 months|2 participants in the control arm did not have data.|||minutes per day||Standard Deviation|Mean
2555888|NCT02733991|Primary|Mean Number of Sensor Glucose Hypoglycaemic Events Below or Equal to 55 mg/dL Per Patient/Week.||6 months|2 participants in the control arm did not have data.|||hypoglycaemic events per week||Standard Deviation|Mean
2555889|NCT02733653|Other Pre-specified|Rate of Hemodynamic Improvement||1 month, 6 months and 12 months|||||||
2555890|NCT02733653|Other Pre-specified|Rate of Primary and Secondary Sustained Clinical Improvement||1 month, 6 months and 12 months|||||||
2555891|NCT02733653|Other Pre-specified|Distribution of Rutherford Class|Distribution of Rutherford Class as compared to baseline at 6 months and 12 months|6 months and 12 months|||||||
2555892|NCT02733653|Other Pre-specified|Adverse Event Rates||1 month, 6 months and 12 months|||||||
2555893|NCT02733653|Other Pre-specified|Clinically-driven Target Vessel Revascularization (TVR) Rate||1 month, 6 months and 12 months|||||||
2555894|NCT02733653|Other Pre-specified|Clinically-driven TLR Rate||1 month, 6 months and 12 months|||||||
2555895|NCT02733653|Other Pre-specified|Assisted Primary Patency|Percentage (%) of lesions without TLR and those with TLR (not due to complete occlusion or by-pass) that reach endpoint without restenosis.|1 month, 6 months and 12 months|||||||
2555896|NCT02733653|Other Pre-specified|Primary Patency|Percentage (%) of lesions that reach endpoint without a hemodynamically significant stenosis on Duplex Ultrasound (DUS) and without Target Lesion Revascularization (TLR) or, bypass of the target lesion.|1 month, 6 months and 12 months|||||||
2555897|NCT02733653|Other Pre-specified|Major Adverse Event (MAE) Rate|All-cause death through 1 month, and/or target limb major amputation and/or Target Lesion Revascularization (TLR) through 12 months|1 month, 6 months and 12 months||||Participants|||Count of Participants
2555898|NCT02733653|Other Pre-specified|Reduction in Lesion Stenosis|The difference between the percent stenosis prior to treatment with Jetstream and the percent stenosis following treatment with Jetstream.|during procedure|||||||
2555899|NCT02733653|Other Pre-specified|Rate of Distal Emboli Requiring Additional Treatment||during procedure or within 24 hours post-index procedure|||||||
2555900|NCT02733653|Other Pre-specified|Procedural Success Rate|Bailout stenting or surgical procedure during the index procedure is not needed|during procedure||||Participants|||Count of Participants
2555901|NCT02733653|Primary|Primary Patency Rate||6 months||||Participants|||Count of Participants
2555902|NCT02733588|Secondary|Glucose Time in Range|Time glucose remains in goal range, 60-180 mg/dl, reported in minutes|0 - 120 minutes following dosing|Includes all subjects who completed a study visit, including repeat visits by 2 subjects.|||Minutes||Standard Deviation|Mean
2555903|NCT02733588|Secondary|Number of Subjects With Rebound Hyperglycemia|Frequency of rebound hyperglycemia defined as glucose levels above 180 mg/dl. Reported as the number of subjects with rebound hyperglycemia.|0 - 120 minutes following dosing|Includes all subjects who completed a study visit, including repeat visits by 2 subjects.|||Participants|||Count of Participants
2555904|NCT02733588|Secondary|Number of Subjects With Severe Hypoglycemia|Frequency of severe hypoglycemia defined as glucose levels below 60 mg/dl. Reported as the number of subjects with severe hypoglycemia.|0 - 120 minutes following dosing|Includes all subjects who completed a study visit, including repeat visits by 2 subjects.|||participants|||Number
2555905|NCT02733588|Primary|Detection/Notification of Hypoglycemia|Frequency with which the device controller software correctly identifies impending hypoglycemia (glucose < 75 mg/dl) and notifies the investigator to initiate treatment. Reported as the number of successful identifications.|0 - 120 minutes following dosing|Includes all subjects who completed a study visit, including repeat visits by 2 subjects.|||successful events|||Number
2555906|NCT02733367|Secondary|Number of Participants Exhibiting a Change in Tanner Development Stage|The Tanner Development Stage was assessed as an additional analysis in this study. All assessments (breast, genitalia, and pubic hair) were Grade 1 (pre-pubertal) at baseline, with only 1 subject (in Cohort 2) showing a change during the study. Subject 018 showed progression to Grade 2 in the pubic hair category (sparse, pigmented hair mainly on labia).|29 months|'Count of Participants' data below represents the number of subjects that exhibited a change from baseline in their Tanner Development Stage.|||Participants|||Count of Participants
2555907|NCT02733367|Secondary|Cortisol Levels|Cortisol levels measured from dried blood spots. The dried blood spots were analysed for multi-steroids, including cortisol (all subjects). Blood spot absolute laboratory values for the safety population are presented. A dried blood spot sample was collected at the initial and final visits, every month for the first 2 months of the study and thereafter every 6 months (unless required after 3 months).|29 months|The reason why n=14 at Visit 1 is because of no result for Subjects 005, 010, 017 & 018. N=12 at Final Visit due to 12 completers.|||nmol/L||Standard Deviation|Mean
2555908|NCT02733367|Secondary|Growth Velocity|Growth velocity standard deviation score (SDS). Body height/length (cm) was obtained at each visit by specially trained paediatric endocrine nurses or physicians using standard calibrated auxological methods.|29 months|Reference data for growth velocity is only available for patients <=6 years old at time of assessment. Therefore n=2 & not 4 for C1 at Month 11. Subject 001 was re-enrolled so no Visit 10 data available and, therefore, n=1 for C1 at Month 23.|||Standard Deviation Score||Standard Deviation|Mean
2555909|NCT02733367|Primary|Incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs)|The primary endpoint was the nature and occurrence of serious adverse events (SAEs) and adverse events (AEs) observed throughout the study. AEs were recorded from the time of the first intake of Infacort until the final visit.|29 months||||adverse events|||Number
2555910|NCT02733042|Secondary|Change From Baseline in Soluble Programmed Cell Death Ligand-1 (sPD-L1) Concentration|Change from baseline in sPD-L1 could not be calculated as all post-baseline samples were below the lower limit of quantification (<15.60 pg/mL).|Baseline (Cycle 1 Day 1 predose) and Day 1 of Cycles 2 to 13|Biomarker Evaluable Population included all participants who received at least 1 dose of study drug and had at least 1 non-missing biomarker assessment. No participants had quantifiable sPD-L1 measurements post-baseline.||||||
2555911|NCT02733042|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) of Ibrutinib||Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose|PK population with available data|||h*ng/mL||Geometric Coefficient of Variation|Geometric Least Squares Mean
2555912|NCT02733042|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Ibrutinib||Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose, and Cycle 1 Day 15 at pre-dose, 1, 2, and 4 hours post-dose.|PK population with available data at each time point|||hours||Full Range|Median
2555913|NCT02733042|Secondary|Maximum Observed Plasma Concentration (Cmax) of Ibrutinib||Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose, and Cycle 1 Day 15 at pre-dose, 1, 2, and 4 hours post-dose.|PK population with available data at each time point|||ng/mL||Geometric Coefficient of Variation|Geometric Least Squares Mean
2555914|NCT02733042|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) of Lenalidomide||Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose|PK population with available data|||h*ng/mL||Geometric Coefficient of Variation|Geometric Least Squares Mean
2555915|NCT02733042|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Lenalidomide||Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose, and Cycle 1 Day 15 at pre-dose, 1, 2, and 4 hours post-dose.|PK population with available data at each time point|||hours||Full Range|Median
2555916|NCT02733042|Secondary|Maximum Observed Plasma Concentration (Cmax) of Lenalidomide||Cycle 1 Day 1 at predose and 1, 2, 4, and 24 hours post-dose, and Cycle 1 Day 15 at pre-dose, 1, 2, and 4 hours post-dose.|PK population with available data at each time point|||ng/mL||Geometric Coefficient of Variation|Geometric Least Squares Mean
2555917|NCT02733042|Secondary|Volume of Distribution (Vz) of Durvalumab||Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.|The PK population|||liters||Geometric Coefficient of Variation|Geometric Least Squares Mean
2555918|NCT02733042|Secondary|Clearance (CL) of Durvalumab||Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.|The PK population|||L/day||Geometric Coefficient of Variation|Geometric Least Squares Mean
2555919|NCT02733042|Secondary|Terminal Elimination Phase Half-Life (t½) of Durvalumab||Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.|The PK population|||days||Geometric Coefficient of Variation|Geometric Least Squares Mean
2555920|NCT02733042|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Durvalumab||Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.|The PK population|||days*μg/L||Geometric Coefficient of Variation|Geometric Mean
2555921|NCT02733042|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) of Durvalumab||Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.|The PK population|||days*μg/L||Geometric Coefficient of Variation|Geometric Mean
2555922|NCT02733042|Secondary|Time to Maximum Plasma Concentration (Tmax) of Durvalumab||Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.|PK population|||days||Full Range|Median
2555923|NCT02733042|Secondary|Maximum Observed Plasma Concentration (Cmax) of Durvalumab||Cycle 1, Day 1 (pre-dose and at end of infusion), and 4, 24, 48, 168 (Day 8), 336 (Day 15), and 508 (Day 22) hours after the end of infusion.|The Pharmacokinetic (PK) population included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration.|||μg/L||Geometric Coefficient of Variation|Geometric Mean
2555924|NCT02733042|Secondary|Kaplan-Meier Estimate of Progression-free Survival (PFS)|Progression-free survival was calculated as the time from first dose of study drug to the first documented progression or death (from any cause) during the entire efficacy evaluation period. For participants with no progression or death, PFS was censored at the last assessment date the participant was known to be progression-free.|From first dose of any study drug to the end of follow-up, up to the data cutoff date of March 6, 2019; median (minimum, maximum) time on study was 16.7 (0.9, 32.9) months.|Safety population|||months||95% Confidence Interval|Median
2556014|NCT02732145|Secondary|Baseline Characteristics: Height|The table shows the height in four groups of patients with and without vulvar discomfort.|ISSVD Questionnaire, up to 30 minutes for each participant.|Baseline characteristics were assessed by anamnestic data (ISSVD Vulvodynia Pattern Questionnaire) and clinical examination.|||cm||Standard Deviation|Mean
2555925|NCT02733042|Secondary|Kaplan-Meier Estimate of Duration of Response|Duration of response is defined for responders only as the time from the first documented response (CR or PR for lymphoma participants or CR, CRi, nPR, PR, or PRL for CLL participants) to disease progression or death (from any cause). For participants with response but no progression, or death, duration of response was censored at the last date that the participant was known to be progression-free.|From first dose of any study drug to the end of follow-up, up to the data cutoff date of March 6, 2019; median (minimum, maximum) time on study was 16.7 (0.9, 32.9) months.|Efficacy evaluable population (all participants who completed at least 1 cycle of their assigned treatment, and have baseline and at least 1 post-baseline tumor response assessment) who had an objective response|||weeks||95% Confidence Interval|Median
2555926|NCT02733042|Secondary|Time to First Response|Time to response was calculated as the time from first dose of study drug to the first response date (CR or PR for lymphoma participants and CR, CRi, nPR, PR, or PRL for CLL participants).|From first dose of any study drug to the end of follow-up, up to the data cutoff date of March 6, 2019; median (minimum, maximum) time on study was 16.7 (0.9, 32.9) months.|Efficacy evaluable population (all participants who completed at least 1 cycle of their assigned treatment, and have baseline and at least 1 post-baseline tumor response assessment) who had an objective response|||weeks||Full Range|Median
2555927|NCT02733042|Secondary|Overall Response Rate During the Entire Study|"For lymphoma participants, response evaluation was based on International Working Group (IWG) response criteria for malignant lymphoma (the Lugano Classification) (Cheson, 2014). Overall response rate is defined as the percent of participants with best response of complete response (CR) or partial response (PR).~For chronic lymphocytic leukemia participants, response evaluation was based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines for diagnosis and treatment of CLL. The ORR is defined as the percentage of participants with best response of CR, complete response with incomplete marrow recovery (CRi), nodular partial response (nPR), PR, or partial response with lymphocytosis (PRL)."|From first dose of any study drug to the end of follow-up, up to the data cutoff date of March 6, 2019; median (minimum, maximum) time on study was 16.7 (0.9, 32.9) months.|The Efficacy Evaluable population includes all participants who completed at least 1 cycle of their assigned treatment, and have baseline and at least 1 post-baseline tumor response assessment.|||percentage of participants||95% Confidence Interval|Number
2555928|NCT02733042|Secondary|Overall Response Rate (ORR) During Durvalumab Treatment|"For lymphoma participants, response evaluation was based on International Working Group (IWG) response criteria for malignant lymphoma (the Lugano Classification). Overall response rate is defined as the percent of participants with best response of complete response (CR) or partial response (PR).~For chronic lymphocytic leukemia participants, response evaluation was based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines for diagnosis and treatment of CLL. The ORR is defined as the percent of participants with best response of CR, complete response with incomplete marrow recovery (CRi), nodular partial response (nPR), PR, or partial response with lymphocytosis (PRL)."|Up to 13 cycles (12 months)|The Efficacy Evaluable population includes all participants who completed at least 1 cycle of their assigned treatment, and have baseline and at least 1 post-baseline tumor response assessment.|||percentage of participants||95% Confidence Interval|Number
2555929|NCT02733042|Primary|Number of Participants With Treatment-emergent Adverse Events|Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) occurring or worsening on or after the first dose of any study treatment (durvalumab, lenalidomide, ibrutinib, bendamustine or rituximab) and within 90 days after last dose of durvalumab or 28 days after the last dose of other study drugs, whichever was later, as well as those serious adverse events made known to the investigator at any time thereafter that were suspected of being related to study treatment. The intensity of AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. For all other AEs not described in the CTCAE criteria, the intensity was assessed by the investigator as mild (Grade 1), moderate (Grade 2), severe (Grade 3), life-threatening (Grade 4), or death (Grade 5).|From first dose of any study drug to 90 days after last dose of durvalumab or 28 days after last dose of other study drugs, up to the data cut-off date of 6 March 2019. Maximum time on treatment was 55.4 weeks for DUR and 130 weeks for other study drugs.|The Safety population included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2555930|NCT02733042|Primary|Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)|"Dose limiting toxicities were evaluated during the DLT evaluation period for participants in the dose finding cohorts. The severity grading was determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. A DLT is defined as below:~Hematologic DLT~Grade 4 neutropenia observed for greater than 5 days duration~Grade 3 neutropenia associated with fever (≥ 38.5 °C) of any duration~Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding, or any requirement for platelets transfusion~Grade 4 anemia, unexplained by underlying disease~Any other grade 4 hematologic toxicity that does not resolve to participant's pretreatment baseline level within 72 hours.~Non-Hematologic DLT~Any non-hematological toxicity ≥ Grade 3 except for alopecia and nausea controlled by medical management~Any treatment interruption greater than 2 weeks due to adverse event."|Cycle 1 (28 days)|DLT Evaluable population included participants in Arms A, B, and C of Part 1, who took at least one dose of study drug and completed the DLT evaluation through the end of DLT evaluation period, or participants who took at least one dose of study drug and experienced at least one DLT prior to completion of the DLT evaluation period.|||Participants|||Count of Participants
2555931|NCT02732951|Secondary|Number of Subjects With Serious Adverse Events (SAEs), Investigator Defined Drug-related Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)|Number of subjects with serious adverse events (SAEs), Investigator defined drug-related Adverse events (AEs) and adverse events of special interest (AESIs) comparing the BI 1026706 treatment group with the placebo group is presented.|From first drug administration until 4 days after last drug administration, up to 89 days.|Treated set (TS): TS includes all patients who were treated with at least 1 dose of trial drug, either BI 1026706 or placebo.|||Count of participants|||Number
2556010|NCT02732145|Secondary|Sexual Activity and Abstinence in Patients With and Without Vulvar Discomfort|The table shows sexual activity and sexual abstinence due to dyspareunia or lack of a sexual partner in four groups of patients.|ISSVD Questionnaire, up to 30 minutes for each participant.|"Sexual activity was evaluated anamnestically by the ISSVD Vulvodynia Pattern Questionnaire."|||Participants|||Count of Participants
2555932|NCT02732951|Primary|Change From Baseline in Central Subfield Foveal Thickness (CSFT) at Week 12|The change from baseline in CSFT at Week 12 and the BI 1026706 effect was compared between the BI 1026706 treatment group and the placebo group as measured by Spectral-domain Optical Coherence Tomography (SD-OCT). Baseline was defined as the CSFT value measured at the visit when patients were randomised. Mean presented here is an adjusted mean.|Baseline and Week 12|Full analysis set (FAS): FAS includes all patients who were randomised, treated with at least 1 dose of BI 1026706 or placebo, and with a baseline and at least one post randomisation central subfield foveal thickness (CSFT) measurement.|||Micrometre [μm]||Standard Deviation|Mean
2555933|NCT02732938|Secondary|Number of Participants With Peripheral Neurological Adverse Events [Phase 2]|To evaluate the improvement of peripheral neurotoxicity induced by nab-paclitaxel by the addition of PF-04136309 to the combination therapy of nab-paclitaxel plus gemcitabine.|Up to approximately 1 year|No data to report as Phase 2 part was not conducted.||||||
2555934|NCT02732938|Secondary|Change From Baseline in Pharmacodynamic (PD) Markers in Metastatic Tumors and Bone Marrow [Phase 2]|Collections of core needle biopsy (CNB) from a metastatic site or fine-needle aspirate (FNA) from the primary tumor tissue were optional but at least 12 paired biopsies would have to be available and fully assessable in each treatment arm to allow the comparison.|Baseline, Cycle 1 Day 28 or Cycle 2 Day 28; EOT visit (optional) for CNB|No data to report as Phase 2 part was not conducted.||||||
2555935|NCT02732938|Secondary|Trough PF-04136309 Concentrations [Phase 2]|The minimum plasma concentration of PF-04136309.|Cycle 1 Day 1 pre-dose, Cycle 1 Days 2, 8 and 15 pre-dose; Day 1 of Cycle 2 and subsequent cycles pre-dose, and EOT visit|No data to report as Phase 2 part was not conducted.||||||
2555936|NCT02732938|Secondary|Time to Progression (TTP) With the Double Combination PF-04136309 and Gemcitabine (Maintenance Therapy) After Interruption of Nab-paclitaxel [Phase 2]|This type of TTP was defined as the time from interruption of nab-paclitaxel to the first documentation of objective tumor progression. This TTP was to be only calculated for the subgroup of participants who were treated with the maintenance therapy.|Up to approximately 1 year|No data to report as Phase 2 part was not conducted.||||||
2555937|NCT02732938|Secondary|Duration of Objective Response (DR) [Phase 2]|DR was defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. DR data were to be censored on the day following the date of the last on treatment (including 28 day follow-up period after last dose) tumor assessment documenting absence of progressive disease for participants who did not have objective tumor progression and who did not die due to any cause while on treatment or who were given anti-tumor treatment other than the study treatment prior to observing objective tumor progression. Participants who achieved a PR and then a CR were to have times calculated using the date of the PR as the first day. DR was only to be calculated for the subgroup of participants with objective response.|Up to approximately 1 year|No data to report as Phase 2 part was not conducted.||||||
2555938|NCT02732938|Secondary|Objective Response Rate (ORR) [Phase 2]|ORR was defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1, relative to all randomized participants who had baseline measurable disease. Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response.|Up to approximately 1 year|No data to report as Phase 2 part was not conducted.||||||
2555939|NCT02732938|Secondary|Number of Participants With Laboratory Abnormalities by Severity [Phase 2]|Hematology, chemistry, and urinalysis laboratory parameters were to be analyzed and graded by NCI CTCAE version 4.03.|Up to approximately 1 year|No data to report as Phase 2 part was not conducted.||||||
2555940|NCT02732938|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) [Phase 2]|An AE was any untoward medical occurrence in a participant administered a product or medical device without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment.|Up to approximately 1 year|No data to report as Phase 2 part was not conducted.||||||
2555941|NCT02732938|Secondary|Number of Participants With Overall Survival (OS) [Phase 2]|OS was defined as the time from date of randomization to date of death due to any cause. For participants not expiring, their survival times were to be censored at the last date they were known to be alive. Participants lacking data beyond the day of randomization were to have their survival times censored at the date of randomization with duration of 1 day.|Up to approximately 13.5 months|No data to report as Phase 2 part was not conducted.||||||
2555942|NCT02732938|Other Pre-specified|Objective Response Rate (ORR) [Phase 1b]|ORR was defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1, relative to all randomized participants who had baseline measurable disease. Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response.|1 year|All the Phase 1b treated participants with measurable disease baseline assessment.|||Percentage of Participants||95% Confidence Interval|Number
2555943|NCT02732938|Secondary|Ex Vivo Inhibition of Chemokine Ligand 2 (CCL2)-Induced Extracellular Signal Regulated Kinase (ERK) Phosphorylation in the Peripheral Blood [Phase 1b]|A drop in the CCL2-induced ERK kinase phosphorylation (pERK) biomarker level indicates target engagement (TE).|Cycle 1 Day 1 pre-dose, 2 and 6 hours post-dose, and 12 hours (pre-second BID dose-optional collection); Cycle 1 Days 2, 3 and 4 pre-dose|No data to report for this outcome measure as only individual plots were planned and generated to show the trend of biomarker level in each participant. Summary statistics were not planned and hence not generated.||||||
2555944|NCT02732938|Secondary|PF-04136309 Apparent Volume of Distribution (Vz/F) for Cycle 1 Day 15 [Phase 1b]|Vz/F was determined by Dose/(AUCtau×kel). AUCtau is the area under the curve from time 0 to end of dosing interval and kel is the terminal phase rate constant.|Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)|All Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had Vz/F data.|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
2555945|NCT02732938|Secondary|PF-04136309 Plasma Decay Half-Life (t1/2) for Cycle 1 Day 15 [Phase 1b]|t1/2 was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.|Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)|All Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had t1/2 data.|||hours (hr)||Standard Deviation|Mean
2555946|NCT02732938|Secondary|PF-04136309 Apparent Oral Clearance (CL/F) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b]|CL/F was determined by Dose/AUCtau. AUCtau is the area under the curve from time 0 to end of dosing interval. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group. Arithmetic CV was the intended method of dispersion for reporting but system only has geometric CV option, hence geometric CV data were reported for this parameter.|Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)|All Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had CL/F data.|||Liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2555947|NCT02732938|Secondary|PF-04136309 Apparent Oral Clearance (CL/F) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b]|CL/F was determined by Dose/AUCtau. AUCtau is the area under the curve from time 0 to end of dosing interval. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data.|Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)|"Number of participants analyzed represents all Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had CL/F data; Number analyzed represents the number of such participants for each category."|||Liters per hour (L/hr)|||Number
2555948|NCT02732938|Secondary|PF-04136309 Minimum Observed Plasma Concentration (Cmin) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b]|Cmin of PF-04136309 was observed directly from data. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group.|Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)|All Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had Cmin data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2555949|NCT02732938|Secondary|PF-04136309 Minimum Observed Plasma Concentration (Cmin) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b]|Cmin of PF-04136309 was observed directly from data. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data.|Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)|"Number of participants analyzed represents all Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had Cmin data; Number analyzed represents the number of such participants for each category."|||ng/mL|||Number
2555950|NCT02732938|Secondary|PF-04136309 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b]|The dosing interval was 12 hours for PF-04136309 BID dosing. AUCtau was determined by linear/log trapezoidal method. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group. Arithmetic CV was the intended method of dispersion for reporting but system only has geometric CV option, hence geometric CV data were reported for this parameter.|Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)|All Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had AUCtau data.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2555951|NCT02732938|Secondary|PF-04136309 Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b]|The dosing interval was 12 hours for PF-04136309 BID dosing. AUCtau was determined by linear/log trapezoidal method. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data.|Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)|"Number of participants analyzed represents all Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had AUCtau data; Number analyzed represents the number of such participants for each category."|||nanogram*hour/milliliter (ng*hr/mL)|||Number
2555952|NCT02732938|Secondary|PF-04136309 Time to Reach Maximum Observed Plasma Concentration (Tmax) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b]|Tmax of PF-04136309 was observed directly from data as time of first occurrence. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group.|Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)|All Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had Tmax data.|||hours (hr)||Full Range|Median
2555953|NCT02732938|Secondary|PF-04136309 Time to Reach Maximum Observed Plasma Concentration (Tmax) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b]|Tmax of PF-04136309 was observed directly from data as time of first occurrence. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data.|Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)|"Number of participants analyzed represents all Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had Tmax data; Number analyzed represents the number of such participants for each category."|||hours (hr)|||Number
2555954|NCT02732938|Secondary|PF-04136309 Maximum Observed Plasma Concentration (Cmax) for Cycle 1 Day 15 in the 500 mg BID Group [Phase 1b]|Cmax of PF-04136309 was observed directly from data. This outcome measure reports summary statistics for the participants in the Phase 1b PF-04136309 500 mg BID +Nab-paclitaxel +Gemcitabine treatment group. Arithmetic coefficient of variation (CV) was the intended method of dispersion for reporting but system only has geometric CV option, hence geometric CV data were reported for this parameter.|Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)|All Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had Cmax data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2555955|NCT02732938|Secondary|PF-04136309 Maximum Observed Plasma Concentration (Cmax) for Cycle 1 Day 15 in the 750 mg BID Group [Phase 1b]|Cmax of PF-04136309 was observed directly from data. This outcome measure reports individual values for the participants in the Phase 1b PF-04136309 750 mg BID +Nab-paclitaxel +Gemcitabine treatment group as summary statistics were not generated when fewer than 3 participants had reportable data.|Cycle 1 Day 15 pre-dose (within 30 minutes), and 0.5, 1, 2, 3, 4, and 6 hours after the morning dose; Cycle 1 Day 16 pre-dose (within 30 minutes; as the 12-hour sample for evening dose on Day 15)|"Number of participants analyzed represents all Phase 1b participants who received planned treatments on Cycle 1 Day 15 and had Cmax data; Number analyzed represents the number of such participants for each category."|||nanograms per milliliter (ng/mL)|||Number
2555956|NCT02732938|Primary|Progression Free Survival (PFS) [Phase 2]|PFS was defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occurred first.|1 year|No data to report as Phase 2 part was not conducted.||||||
2555957|NCT02732938|Primary|Number of Participants With Urinalysis Laboratory Abnormalities by Maximum NCI CTCAE Grade [Phase 1b]|Following parameters were analyzed for urinalysis laboratory test: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy (only if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase), urine dipstick for urine protein (if positive collected 24 hour and microscopic [reflex testing]), urine dipstick for urine blood (if positive collected a microscopic [reflex testing]). Laboratory abnormalities were graded per NCI CTCAE version 4.03 and those with at least 1 participant are presented here.|1 year|All Phase 1b participants who received at least 1 dose of study treatment and had at least 1 post-dose urinalysis laboratory test.|||Participants|||Count of Participants
2555958|NCT02732938|Primary|Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade [Phase 1b]|Following parameters were analyzed for chemistry laboratory test: blood urea nitrogen (BUN), creatinine, glucose (fasting), calcium, sodium, potassium, chloride, total bicarbonate, AST, ALT, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, Magnesium, phosphorous or phosphate. For potential Hy's Law cases, in addition to repeating AST and ALT, laboratory tests should have included albumin, creatine kinase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase (GGT), prothrombin time / international normalized ratio (PT/INR), alkaline phosphatase, total bile acids, and acetaminophen drug and/or protein adduct levels. Laboratory abnormalities were graded per NCI CTCAE version 4.03 and those with at least 1 participant are presented here.|1 year|All Phase 1b enrolled participants who received at least 1 dose of study treatment. GGT was an additional test for potential Hy's law. Only 1 participant in the PF-04136309 500 mg BID + Nab-paclitaxel + Gemcitabine treatment group was tested for GGT.|||Participants|||Count of Participants
2555959|NCT02732938|Primary|Number of Participants With Hematology Laboratory Abnormalities by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade [Phase 1b]|Following parameters were analyzed for hematology laboratory test: hemoglobin, hematocrit, red blood cell (RBC) count, mean corpuscular volume (MCV); mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelet count, white blood cell (WBC) count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes. Laboratory abnormalities were graded per NCI CTCAE version 4.03 and those with at least 1 participant are presented here.|1 year|All Phase 1b enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2555960|NCT02732938|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity [Phase 1b]|Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.|1 year|All Phase 1b enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2555961|NCT02732938|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Phase 1b]|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment.|1 year|All Phase 1b enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2555962|NCT02732938|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs) [Phase 1b]|DLT: Any of the following events occurred in the first treatment cycle and was attributed to the combination of PF-04136309 with nab-paclitaxel and gemcitabine where relationship with the combination could not be ruled out. Hematologic: Grade (Gr) 4 neutropenia lasting more than (>)5 days; febrile neutropenia; Gr≥3 neutropenic infection; Gr≥3 thrombocytopenia with Gr≥2 bleeding; Gr4 thrombocytopenia. Non-Hematologic: Gr3 toxicities (except: nausea and vomiting responding to prophylaxis and/or treatment and lasting less than (<)7 days from each chemotherapy infusion period; diarrhea responding to treatment and lasting <7 days; Gr3 QTc prolongation [QTc >500 milliseconds] [a DLT only if persisting after correction of any reversible causes]; Gr3 aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) increase lasting less than or equal to (≤)7 days); all Gr4 toxicities; delay of >2 weeks in receiving the next scheduled cycle due to persisting treatment-related toxicities.|Day 1 to Day 28|All Phase 1b enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2555964|NCT02732912|Secondary|Number of Falls|The number of falls, if any, will be extracted from the hospital incident recording system for the patient at the time of discharge. The data will be reported simply as the number of patients experiencing a fall; not the total number of falls experienced by the patients who had a fall. The data were taken from the electronic patient records and were not available for patients (n = 2) still in hospital at the time of discharge.|From date of admission to date of discharge, up to 90 days|All patients were analysed. Two patients, one in each group, had not been discharged when data collection ended and data on falls were not available. The value of zero falls was used.|||Participants|||Count of Participants
2555965|NCT02732912|Secondary|Use of Zopiclone (Night Sedation)|"The number of patients taking zopiclone during their stay. Data was taken from the Electronic patient record and was not available for any patient not discharged at the end of the study (one in each group).~NOT the original intention of measuring the total dose of zopiclone taken during the admission will be recorded; this is available from the electronic drug chart used in the hospital"|From date of admission to date of discharge, up to 90 days|All patients were analysed. Two patients had not been discharged (one in each group) when data collection ended. In that instance, the number of doses of zopiclone could not be ascertained, and zero was used in the analysis.|||Participants|||Count of Participants
2555966|NCT02732912|Secondary|Length of Stay|Time in days from admission to discharge from hospital (not from ward). These data were derived from the hospital administration data-base.|From date of admission to date of discharge, up to 90 days|All patients were analysed. Two patients (one in each group) had not been discharged when data collection ended. In that instance, the number of days from recruitment to the end-of-study date was used.|||days||Standard Deviation|Mean
2555967|NCT02732912|Primary|SleepSure (Questionnaire). A Short Questionnaire of the Quality and Quantity of Sleep, and Use of Aids.|SleepSure is a short questionnaire which asks the patient to rate their sleep using a 1-10 numerical rating scale for eight items covering the quality of their sleep (e.g. difficulty getting to sleep, interruptions). Two additional questions recorded the use of aids. It takes no more that 2-3 minutes to complete. The eight numerical rating scores are summed and divided by 8 to give a score from 1 (very good sleep) to 10 (very poor sleep).|At end of first night in hospital after recruitment (i.e. the next morning)||||units on a scale||Standard Deviation|Mean
2555968|NCT02732899|Secondary|Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36||baseline to week 36||||letters||Full Range|Mean
2555969|NCT02732899|Primary|Change in Central Subfield Thickness on OCT From Baseline to Week 36|the amount of change in intraretinal and subretinal fluid as measured by microns of central subfield thickness (CST) on Heidelberg Optical Coherence Tomography (OCT)|baseline to week 36||||microns||Full Range|Mean
2555970|NCT02732639|Secondary|Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72|Samples were collected and analyzed for HBsAb. Positive HBsAb levels are defined as levels above the level of detection of the assay and reflect the presence of antibodies produced against HBsAg.|At Weeks 48 and 72|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.|||percentage of participants||95% Confidence Interval|Number
2555971|NCT02732639|Secondary|Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72|Samples were collected and analyzed for HBsAg. Seronegative HBsAg is defined as below the level of detection of the assay.|At Weeks 48 and 72|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.|||percentage of participants||95% Confidence Interval|Number
2555972|NCT02732639|Secondary|Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels|Samples were collected and analyzed for HBsAg. Positive HBsAg levels are defined as levels above the level of detection of the assay.|At Screening and at Weeks 48 and 72|Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.|||participants|||Number
2555973|NCT02732639|Secondary|Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72|Samples were collected and analyzed for HBV DNA levels. Reported here is the percentage of participants with HBV DNA levels below 1*10^5 copies/mL.|At Weeks 48 and 72|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.|||percentage of participants||95% Confidence Interval|Number
2555974|NCT02732639|Secondary|Percentage of Participants With Negative HDV RNA at Week 48|Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.|At Week 48|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.|||percentage of participants||95% Confidence Interval|Number
2555975|NCT02732639|Secondary|Percentage of Participants With Normal ALT at Week 48|Samples were collected and analyzed for ALT levels. A normal ALT is a value within the normal range of the assay.|At Week 48|ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.|||percentage of participants||95% Confidence Interval|Number
2555976|NCT02732639|Primary|Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72|Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.|At Week 72|Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.|||percentage of participants||95% Confidence Interval|Number
2555977|NCT02732639|Primary|Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72|Samples were collected and analyzed for ALT. A normal ALT is a value within the normal range of the assay.|At Week 72|Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment.|||percentage of participants||95% Confidence Interval|Number
2555978|NCT02732587|Primary|Safety/Tolerability of Study Medication.|Number of subjects - taking 125 mg of AZD0530 (saracatinib) over 8 days - in an alcohol drinking paradigm raising blood alcohol to 80 mg/dl who had any concerning changes in physiological or behavioral outcome measures.|8 days||||participants|||Number
2555979|NCT02732561|Primary|Anxiety|Hamilton Anxiety Rating Scale. The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety (Hamilton, 1959; McDowell, Newell & & McDowell, 2006). The scale consists of 14 items designed to assess the severity of a patient's anxiety. Each of the 14 items contains a number of symptoms, and each group of symptoms is rated on a scale of zero to four, with four being the most severe (with a total score range of 0-56). All of these scores are used to compute an overarching score that indicates a person's anxiety severity (Vaccarino, 2008). A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. Lastly, a score of 25 to 30 indicates a moderate to severe anxiety severity. Higher values represent a worse outcome.|4 weeks|includes only matched pairs|||units on a scale||Full Range|Median
2555980|NCT02732561|Primary|Depressive Symptoms|Hamilton Depression Rating Scale. The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression and as a guide to evaluate recovery (Hedlund, 1979). The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Assessment time is estimated at 20 minutes (Hamilton, 1960). Higher values represent a worse outcome. The HAM-D form lists 21 items, the scoring is based on the first 17.Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2, with a total score range of 0-50.|4 weeks|Only includes matched pairs|||units on a scale||Full Range|Median
2555981|NCT02732327|Primary|Percentage of Patients With Favorable Clinical Response at End of Inpatient Intravenous Therapy (EOIV)|Favorable clinical response is defined as resolution of all acute signs and symptoms of the primary infection or improvement to such an extent that no additional antibacterial therapy is required as assessed by the investigator. Due to study termination and limited enrollment, outcome measures were not analyzed.|Up to Day 14|||||||
2555982|NCT02732210|Secondary|Percentage of Participants Satisfying Medication-taking Behavior at 24 Months|Percentage of participants satisfying medication-taking behavior defined as the participant received all 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections did not exceed 6 months with a grace period of ± 4 weeks.|24 months|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2555983|NCT02732210|Secondary|Percentage of Participants Satisfying Medication-taking Behavior at 12 Months|Percentage of participants satisfying medication-taking behavior defined as, following the first Prolia® injection, the participant received a second Prolia® injection and the length of time between the first and the second Prolia® injection did not exceed 6 months with a grace period of ± 4 weeks.|12 months|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2555984|NCT02732210|Secondary|Number of Prolia® Injections Received|The number of injections that a participant received over 24 months (including the baseline injection) regardless of when the injection was received.|24 months|Full analysis set|||prolia injections||Inter-Quartile Range|Median
2555985|NCT02732210|Secondary|Time to Non-persistence|For non-persistent participants, time to non-persistence was calculated as the time between the date of the first injection and the date of last injection received during the period where the participant was still classified as persistent plus 6 months (183 days).|24 months|Full analysis set with non-persistence at 24 months|||months||Inter-Quartile Range|Median
2555986|NCT02732210|Primary|Percentage of Participants With Persistence With Prolia® at 24 Months|A participant was considered persistent with Prolia® at 24 months if they received at least 4 Prolia® injections and the length of time between any 2 consecutive Prolia® injections does not exceed 6 months plus 8 weeks (239 days).|24 months|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2555987|NCT02732210|Primary|Percentage of Participants With Persistence With Prolia® at 12 Ponths|A participant was considered persistent with Prolia® at 12 months if they received at least 2 Prolia® injections no more than 6 months plus 8 weeks (239 days) apart.|12 months|Full Analysis Set (all enrolled participants)|||percentage of participants||95% Confidence Interval|Number
2555988|NCT02732145|Secondary|Histopathological Features of the Vulvar Dermis in Patients With Vulvodynia Depending on The Duration of Vulvar Discomfort|"The table shows the relationship between histopathological features of the vulvar dermis depending on the duration of vulvar discomfort (less or more than 24 months) in 82 patients with vulvodynia, diagnosed anamnestically and clinically following Friedrich's criteria.~Histopathological characteristics of vulvar dermis included inflammatory infiltrates (mononuclear, lymphocytes, mastocytes), collagen fibers, hyalinization, hyperpigmentation, elongated dermal papillae, blood vessels, sebaceous glands, and nerve fibers."|Histopathological Examination, up to 30 minutes for each vulvar sample.|We performed a biopsy of the vulva in 82 symptomatic patients with vulvodynia diagnosed anamnestically and by clinical examination following Friedrich's criteria during the routine clinical care, to exclude other skin diseases.|||Participants|||Count of Participants
2555989|NCT02732145|Secondary|Histopathological Features of Vulvar Dermis in Patients With Vulvar Dermatosis Depending On The Duration of Vulvar Discomfort|"The table shows the relationship between histopathological features of the vulvar dermis depending on the duration of vulvar discomfort (less or more than 24 months) in 82 consecutive patients with vulvar dermatosis.~Histopathological characteristics of vulvar dermis included inflammatory infiltrates (mononuclear, lymphocytes, mastocytes), collagen fibers, hyalinization, hyperpigmentation, elongated dermal papillae, blood vessels, sebaceous glands, and nerve fibers."|Histopathological Examination, up to 30 minutes for each vulvar sample.|We performed a biopsy of the vulva in 82 symptomatic patients with vulvar dermatosis diagnosed anamnestically and by clinical examination during the routine clinical care, to confirm the diagnosis on histopathology.|||Participants|||Count of Participants
2556013|NCT02732145|Secondary|Baseline Characteristics: BMI|The table shows the body mass index (Mean ± SD) in four groups of patients with and without vulvar discomfort.|ISSVD Questionnaire, up to 30 minutes for each participant.|Baseline characteristics were assessed by anamnestic data (ISSVD Vulvodynia Pattern Questionnaire) and clinical examination.|||kg/m^2||Standard Deviation|Mean
2556082|NCT02731469|Secondary|Tmax|Time from 9 hours to time of maximal concentration of drug in blood after single injection|0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose||||hours||Inter-Quartile Range|Median
2555990|NCT02732145|Secondary|Histopathological Features of the Vulvar Epidermis and Vulvar Complaints in Patients With Vulvodynia|"The table shows the relationship between histopathological features of the vulvar epidermis (normal versus abnormal), and single vulvar symptoms from the categories of the dull (slow) and sharp (fast) pain of the vulva in 82 patients with vulvodynia diagnosed anamnestically and clinically following Friedrich's criteria.~The dull pain comprises sensations of burning, stinging, soreness, irritation, itching, inflammation and aching. The fast pain includes sensations like sticking and stabbing, paper-cut or knife-like pain."|Histopathological Examination, up to 30 minutes for each vulvar sample.|We performed a biopsy of the vulva in 82 symptomatic patients with vulvodynia diagnosed anamnestically and by clinical examination following Friedrich's criteria during the routine clinical care, to exclude other skin diseases on histopathology.|||Participants|||Count of Participants
2555991|NCT02732145|Secondary|Histopathological Features of the Vulvar Epidermis and Vulvar Discomfort in Patients With Vulvar Dermatosis|"The table shows the relationship between histopathological features of the vulvar epidermis (normal versus abnormal) and single vulvar symptoms from the categories of the dull (slow) and sharp (fast) pain of the vulva in 82 patients with vulvar dermatosis.~The dull pain comprises sensations of burning, stinging, soreness, irritation,itching, inflammation and aching.~The fast pain includes sensations like sticking and stabbing, paper-cut or knife-like pain."|Histopathological Examination, up to 30 minutes for each vulvar sample.|We performed a biopsy of the vulva in 82 symptomatic patients with vulvar dermatosis diagnosed anamnestically and by clinical examination during the routine clinical care, to confirm the diagnosis on histopathology.|||Participants|||Count of Participants
2555992|NCT02732145|Secondary|Histopathological Characteristics of Vulvar Specimens in Patients With And Without Vulvar Discomfort|"The table shows the distribution of histopathological findings of vulvar epidermis among patients with and without vulvar discomfort, classified into four groups based on anamnestic data, clinical examination and Three Rings Vulvoscopy. Histopathological characteristics of vulvar epidermis included hyperkeratosis, parakeratosis, acanthosis, and epidermal atrophy. In the vulvar dermis, there were evaluated presence of inflammatory infiltrates (monocytes, lymphocytes, mastocytes), collagen fibers, hyalinization, hyperpigmentation, elongated dermal papillae, blood vessels, sebaceous glands, and nerve fibers."|Histopathological Examination, up to 30 minutes for each vulvar sample.|We performed a biopsy of the vulva in 164 symptomatic patients during the routine clinical care to histopathologically confirm or exclude a skin disorder. Vulvar specimens from 164 asymptomatic patients were granted from the women undergoing planned labiaplasty.|||Participants|||Count of Participants
2555993|NCT02732145|Secondary|Distribution of Aceto-Whitening Reaction in Relation to the Structures of the Inner Vulvar Ring|"The table shows the distribution of aceto-whitening reaction (AWR) after 5% acetic acid application (AWR - aceto-whitening reaction) in relation to the structures of the Inner Vulvar Ring.~The INNER Vulvar Ring is presented with the following structures: the clitoris, Hart's line, the urethral sulcus, the urethral meatus, hymenal remnants, Bartholin's gland opening, and the vestibule.~Acetic acid is thought to cause swelling of the epithelial tissue through reversible coagulation or precipitation of the nuclear proteins and cytokeratins.~Areas of pre-/malignant lesions turn densely white and opaque immediately after application of acetic acid, due to the presence of large numbers of dysplastic cells in the superficial layers of the epithelium.~The acetowhite appearance is not unique to pre-/malignancy; it is also seen in other conditions with increased nuclear protein. The acetowhite reaction varies in intensity, within and between patients."|Aceto-Whitening Test, up to 10 minutes for each participant.|"We performed the aceto-whitening test with 5% acetic acid application in 328 patients, classified into four groups based on anamnestic data and clinical examination. Localization and type, as well as the velocity of the AWR, were mapped into the TRIV Form Data. Aceto-Whitening of all structures of the Inner vulvar ring was named Ring sign."|||Participants|||Count of Participants
2555994|NCT02732145|Secondary|Distribution of Aceto-Whitening Reaction in Relation to the Structures of the Middle Vulvar Ring|"The distribution of aceto-whitening occurrence after 5% acetic acid application (AWR - aceto-whitening reaction) in relation to the structures of the Middle Vulvar Ring.~The MIDDLE vulvar ring encompasses the following structures: the anterior commissure with the prepuce of the clitoris, interlabial sulci, labia minora, and the posterior commissure."|Aceto-Whitening Test, up to 10 minutes for each participant.|"We performed the aceto-whitening test with 5% acetic acid application in 328 patients, classified into four groups based on anamnestic data and clinical examination. Localization and type, as well as the velocity of the AWR, were mapped into the TRIV Form Data."|||Participants|||Count of Participants
2555995|NCT02732145|Secondary|Distribution of Aceto-Whitening Reaction in Relation to the Structures of the Outer Vulvar Ring|"The table shows the distribution of aceto-whitening occurrence (AWR) after 5% acetic acid application in relation to the structures of the Outer Vulvar Ring.~The OUTER Vulvar Ring is presented with the following structures: Mons Pubis, Labia Majora, and the Perineum.~Acetic acid is thought to cause swelling of the epithelial tissue through reversible coagulation or precipitation of the nuclear proteins and cytokeratins.~Areas of pre-/malignant lesions turn densely white and opaque immediately after application of acetic acid, due to the presence of large numbers of dysplastic cells in the superficial layers of the epithelium.~The acetowhite appearance is not unique to pre-/malignancy; it is also seen in other conditions with increased nuclear protein. The acetowhite reaction varies in intensity, within and between patients."|Aceto-Whitening Test, up to 10 minutes for each participant.|"We performed the aceto-whitening test with 5% acetic acid application in 328 patients, classified into four groups based on anamnestic data and clinical examination. Localization and type, as well as the velocity of the AWR, were mapped into the TRIV Form Data."|||Participants|||Count of Participants
2556011|NCT02732145|Secondary|Various Characteristics and Duration of Vulvar Discomfort in Patients With Vulvar Dermatosis and Vulvodynia|"The table shows various characteristics of vulvar pain (complaints) in patients with vulvar dermatosis or vulvodynia.~Generally, we can differentiate between two categories of pain - the dull pain vs. the sharp pain depending on the nerve fibers in the skin, which are involved in the provocation of the pain.~The symptoms of the dull pain are burning, stinging, soreness, irritation, itching, feeling of inflammation and aching.~The symptoms of the sharp pain are a knife-like pain, paper-cuts pain, stabbing and sticking. We do not know, are there some symptoms characteristic for vulvar dermatosis or vulvodynia."|ISSVD Questionnaire, up to 30 minutes for each participant.|"Vulvar discomfort was evaluated anamnestically by the ISSVD Vulvodynia Pattern Questionnaire."|||Participants|||Count of Participants
2555996|NCT02732145|Secondary|"Velocity of Aceto-Whitening Reaction (Median | Range)"|"The table shows the velocity (Median | Range) of the aceto-whitening occurrence after 5% acetic acid application (AWR - aceto-whitening reaction) in patients with positive AWR classified into four groups based on anamnestic data and clinical examination.~Acetic acid is thought to cause swelling of the epithelial tissue through reversible coagulation or precipitation of the nuclear proteins and cytokeratins.~Areas of pre-/malignant lesions turn densely white and opaque immediately after application of acetic acid, due to their higher concentration of abnormal nuclear protein and the presence of large numbers of dysplastic cells in the superficial layers of the epithelium.~The acetowhite appearance is not unique to pre-/malignancy; it is also seen in other conditions with increased nuclear protein like immature squamous metaplasia, regeneration, inflammation, HPV-infection, hyperkeratosis, etc. The acetowhite reaction varies in intensity, within and between patients."|Aceto-Whitening Test, up to 10 minutes for each participant.|"The velocity of the AWR was measured with a stopwatch and noted into the TRIV Form Data only in the patients with a positive test."|||second||Full Range|Median
2555997|NCT02732145|Secondary|Velocity of the Aceto-Whitening Reaction (Mean ± SD)|"The table shows the velocity (Mean ± SD) of the aceto-whitening occurrence after 5% acetic acid application (AWR - aceto-whitening reaction) in patients with positive AWR classified into four groups based on anamnestic data and clinical examination.~Acetic acid is thought to cause swelling of the epithelial tissue through reversible coagulation or precipitation of the nuclear proteins and cytokeratins.~Areas of pre-/malignant lesions turn densely white and opaque immediately after application of acetic acid, due to their higher concentration of abnormal nuclear protein and the presence of large numbers of dysplastic cells in the superficial layers of the epithelium.~The acetowhite appearance is not unique to pre-/malignancy; it is also seen in other conditions with increased nuclear protein like immature squamous metaplasia, regeneration, inflammation, HPV-infection, hyperkeratosis, etc. The acetowhite reaction varies in intensity, within and between patients."|Aceto-Whitening Test, up to 10 minutes for each participant.|"The velocity of the AWR was measured with a stopwatch and noted into the TRIV Form Data only in the patients with a positive test."|||second||Standard Deviation|Mean
2555998|NCT02732145|Secondary|Aceto-Whitening Reaction (AWR) in Relation to the Three Vulvar Rings|"The table shows the presence, the quality, and the distribution of the aceto-whitening reaction after 5% acetic acid application (Aceto-Whitening Test), in relation to the three vulvar rings.~The OUTER Vulvar Ring includes vulvar skin, the MIDDLE Vulvar Ring encompasses the modified mucosa, and the INNER Vulvar Ring is presented with glicogenized mucosa.~Acetic acid is thought to cause swelling of the epithelial tissue through reversible coagulation or precipitation of the nuclear proteins and cytokeratins.~Areas of pre-/malignant lesions turn densely white and opaque immediately after application of acetic acid, due to the presence of large numbers of dysplastic cells in the superficial layers of the epithelium.~The acetowhite appearance is not unique to pre-/malignancy; it is also seen in other conditions with increased nuclear protein. The acetowhite reaction varies in intensity, within and between patients."|Aceto-Whitening Test, up to 10 minutes for each participant.|"The Aceto-Whitening test was performed in 328 patients, classified into four groups based on anamnestic data and clinical examination. Localization and type, as well as the velocity of the AWR, were mapped into the TRIV Form Data. Aceto-Whitening of all structures of the Inner Vulvar Ring was named Ring sign."|||Participants|||Count of Participants
2555999|NCT02732145|Secondary|"Distribution of Non-Specific and Specific Lesions of the Inner Vulvar Ring According to the Three Rings Vulvoscopy"|"The table shows the distribution of non-specific and specific lesions of the vulva in relation to the individual structures of the Inner vulvar ring according to the Three Rings Vulvoscopy. The INNER vulvar ring includes clitoris, Hart's line, urethral sulcus, urethral meatus, hymenal remnants, Bartholin's gland opening, and the vestibule.~Non-Specific Lesions include non-specific erythema, punctuations, papillae, paleness and smoothness, fissures or sores in the absence of infection and pre/malignancy in any part of the vulva.~Specific Lesions comprise eczematous inflammation with thickened, excoriated skin within chronic lichen simplex; hypopigmented or white lesions, fusion or resorption of the labia minora and clitoral hood, loss of vulvar architecture and sclerotic changes in lichen sclerosis; white reticular pattern to extensive erosion with agglutination or resorption of the labia within lichen planus and psoriatic erythematous papules with silver, scaly plaques."|Three Rings Vulvoscopy, up to 45 minutes for each participant.|"Three Rings Vulvoscopy was performed in 328 patients, classified into four groups based on anamnestic data and clinical examination. Localization and specificity of the lesions were mapped into the TRIV Form Data. Vulvar lesions in patients with vulvodynia were not relevant for the diagnosis of vulvodynia which was made by Friedrich's criteria."|||Participants|||Count of Participants
2556000|NCT02732145|Secondary|"Distribution of Non-Specific and Specific Lesions of the Middle Vulvar Ring According to the Three Rings Vulvoscopy"|"The table shows the distribution of non-specific and specific lesions of the vulva in relation to the individual structures of the Middle vulvar ring according to the Three Rings Vulvoscopy. The MIDDLE vulvar ring includes the anterior commissure with the prepuce of the clitoris, interlabial sulci, labia minora, and the posterior commissure.~Non-Specific Lesions include non-specific erythema, punctuations, papillae, paleness and smoothness, fissures or sores in the absence of infection and pre/malignancy in any part of the vulva.~Specific Lesions comprise eczematous inflammation with thickened, excoriated skin within chronic lichen simplex; hypopigmented or white lesions, fusion or resorption of the labia minora and clitoral hood, loss of vulvar architecture and sclerotic changes in lichen sclerosis; white reticular pattern to extensive erosion with agglutination or resorption of the labia within lichen planus and psoriatic erythematous papules with silver, scaly plaques."|Three Rings Vulvoscopy, up to 45 minutes for each participant.|"Three Rings Vulvoscopy was performed in 328 patients, classified into four groups based on anamnestic data and clinical examination. Localization and specificity of the lesions were mapped into the TRIV Form Data. Vulvar lesions in patients with vulvodynia were not relevant for the diagnosis of vulvodynia which was made by Friedrich's criteria."|||Participants|||Count of Participants
2556012|NCT02732145|Secondary|Demographic Data in Patients With and Without Vulvar Discomfort|The table shows demographic data - age: more or less than 65 years, reproductive age, menopause, domicile country as a country of birth, the degree of education (more and less than 12 years), marital status, births, abortions, and using of contraception among four groups of patient.|ISSVD Questionnaire, up to 30 minutes for each participant.|We assesses demographic data by ISSVD Vulvodynia Pattern Questionnaire (anamnestic).|||Participants|||Count of Participants
2556001|NCT02732145|Secondary|"Distribution of Non-Specific and Specific Lesions of the Outer Vulvar Ring According to the Three Rings Vulvoscopy"|"The table shows the distribution of the non-specific and specific lesions of the vulva according to individual structures of the Outer Vulvar Ring according to the TRIV.~The OUTER Vulvar Ring includes vulvar skin with the following structures: mons pubis, labia majora, and the perineum.~Non-Specific Lesions include non-specific erythema, punctuations, papillae, paleness and smoothness, fissures or sores in the absence of infection and pre/malignancy in any part of the vulva.~Specific Lesions (lesions specific for vulvar dermatosis) comprise eczematous inflammation with thickened, excoriated skin within chronic lichen simplex; hypopigmented or white lesions, fusion or resorption of the labia minora and clitoral hood, loss of vulvar architecture and sclerotic changes in lichen sclerosis; white reticular pattern to extensive erosion with agglutination or resorption of the labia within lichen planus and psoriatic erythematous papules with silver, scaly plaques."|Three Rings Vulvoscopy, up to 45 minutes for each participant.|"Three Rings Vulvoscopy was performed in 328 patients, classified into four groups based on anamnestic data and clinical examination. Localization and specificity of the lesions were mapped into the TRIV Form Data. Vulvar lesions in patients with vulvodynia were not relevant for the diagnosis of vulvodynia which was made by Friedrich's criteria."|||Participants|||Count of Participants
2556002|NCT02732145|Secondary|Distribution of Non-Specific and Specific Vulvar Lesions in Relation to The Three Vulvar Rings (TRIV)|"The table shows the distribution of non-specific and specific vulvar lesions in relation to the three vulvar rings (TRIV).~The OUTER Vulvar Ring includes vulvar skin, the MIDDLE Vulvar Ring encompasses the modified mucosa, and the INNER Vulvar Ring is presented with glicogenized mucosa.~Non-Specific Lesions include non-specific erythema, punctuations, papillae, paleness and smoothness, fissures or sores in the absence of infection and pre/malignancy in any part of the vulva.~Specific Lesions comprise eczematous inflammation with thickened, excoriated skin within chronic lichen simplex; hypopigmented or white lesions, fusion or resorption of the labia minora and clitoral hood, loss of vulvar architecture and sclerotic changes in lichen sclerosis; white reticular pattern to extensive erosion with agglutination or resorption of the labia within lichen planus and psoriatic erythematous papules with silver, scaly plaques."|Three Rings Vulvoscopy, up to 45 minutes for each participant.|"Three Rings Vulvoscopy was performed in 328 patients, classified into four groups based on anamnestic data and clinical examination. Localization and specificity of the lesions were mapped into the TRIV Form Data. Vulvar lesions in patients with vulvodynia were not relevant to the diagnosis of vulvodynia which was made by Friedrich's criteria."|||Participants|||Count of Participants
2556003|NCT02732145|Secondary|Cotton Swab Test (Q-Tip) in Patients With and Without Vulvar Discomfort|"The table shows the results of Cotton-Swab Test in four groups of patients. Cotton-Swab Test or Q-Tip Testing is part of a multidisciplinary approach to the assessment of sexual pain, especially, vulvodynia or vestibulodynia, in women. ISSVD recommended the Cotton-Swab test for the differential diagnosis of vulvodynia.~The test consists of using a cotton-swab to palpate multiple vulvar and vestibular site while recording the woman's pain.~We performed Cotton-Swab Test by touching the vulva at 6 points (each vulvar ring), organized into locations based on a clock face and marked like the hours on the clock: 2h, 4h, 6h, 8h, 10h, and 12 h."|Cotton Swab Test, up to 10 minutes for each participant.|"Cotton-Swab test was evaluated by clinical examination of the Inner Vulvar Ring (TRIV Data Form)."|||Participants|||Count of Participants
2556004|NCT02732145|Secondary|Previous Treatment of Patients With Vulvar Dermatosis and Vulvodynia|The table shows the incidence of the previous treatment in patients with vulvar dermatosis and vulvodynia.|ISSVD Questionnaire, up to 30 minutes for each participant.|"Previous treatment was evaluated anamnestically by the ISSVD Vulvodynia Pattern Questionnaire."|||Participants|||Count of Participants
2556005|NCT02732145|Secondary|Other Associated Symptoms and Diseases in Patients With and Without Vulvar Discomfort|The table shows the incidence of the other associated symptoms and diseases in four groups of patients, as recommended in the ISSVD Questionnaire.|ISSVD Questionnaire, up to 30 minutes for each participant.|"Other associated symptoms and diseases were evaluated anamnestically by the ISSVD Vulvodynia Pattern Questionnaire."|||Participants|||Count of Participants
2556006|NCT02732145|Secondary|Problems Associated With Urination and Defecation in Patients With and Without Vulvar Discomfort|The table shows the incidence of the problems with urination and defecation in four groups of patients with and without vulvar discomfort.|ISSVD Questionnaire, up to 30 minutes for each participant.|"Problems with urination and defecation were evaluated anamnestically by the ISSVD Vulvodynia Pattern Questionnaire."|||Participants|||Count of Participants
2556007|NCT02732145|Secondary|Aggravation of Vulvar Discomfort Through Various Triggers in Patients With Vulvar Dermatosis and Vulvodynia|The table shows the relationship among worsening of vulvar discomfort by using tampons, cycling, wearing tight clothes, menstruation, and urination in patients with vulvar dermatosis and vulvodynia.|ISSVD Questionnaire, up to 30 minutes for each participant.|"Worsening of vulvar discomfort by the using of tampons, cycling, wearing tight clothes, menstruation and urination in symptomatic patients were evaluated anamnestically by the ISSVD Vulvodynia Pattern Questionnaire."|||Participants|||Count of Participants
2556008|NCT02732145|Secondary|Aggravation Of Vulvar Complaints Depending On Sexual Intercourse In Patients With Vulvar Dermatosis And Vulvodynia|The relationship between sexual vulvar discomfort and sexual intercourse (provocation and aggravation) in patients with vulvar dermatosis and vulvodynia, as recommended in the ISSVD Questionnaire.|ISSVD Questionnaire, up to 30 minutes for each participant.|"Provocation and aggravation of vulvar discomfort depending on sexual intercourse were evaluated anamnestically by the ISSVD Vulvodynia Pattern Questionnaire."|||Participants|||Count of Participants
2556009|NCT02732145|Secondary|Dyspareunia and Marinoff Index in Patients With and Without Vulvar Discomfort|"The table shows the degree of dyspareunia in sexually active patients with and without vulvar discomfort. We used Marinoff Index as a measure of the degree of dyspareunia.~Negative Marinoff Index (0) is a sign of the absence of dyspareunia.~Four grades of Marionoff Index are:~Marinoff Index 0 = no dyspareunia; Marinoff Index 1= discomfort/pain with intercourse that doesn't interfere with the frequency of sex; Marinoff Index 2= pain with intercourse which sometimes prevents intercourse and Marinoff Index 3= pain with intercourse preventing any intercourse."|ISSVD Questionnaire, up to 30 minutes for each participant.|"Dyspareunia and Marinoff Index were evaluated anamnestically by the ISSVD Vulvodynia Pattern Questionnaire. We assessed the degree of dyspareunia only in sexually active patients."|||Participants|||Count of Participants
2556015|NCT02732145|Secondary|Baseline Characteristics: Weight|The table shows the weight in four groups of patients with and without vulvar discomfort.|ISSVD Questionnaire, up to 30 minutes for each participant.|Baseline characteristics were assessed by anamnestic data (ISSVD Vulvodynia Pattern Questionnaire) and clinical examination.|||kg||Standard Deviation|Mean
2556016|NCT02732145|Secondary|Baseline Characteristics: Age|The table shows the age in four groups of patients with and without vulvar discomfort.|ISSVD Questionnaire, up to 30 minutes for each participant.|Baseline characteristics were assessed by anamnestic data (ISSVD Vulvodynia Pattern Questionnaire) and clinical examination.|||years||Standard Deviation|Mean
2556017|NCT02732145|Primary|"Distribution of Vulvar Lesions According to the N-S-P Scheme in Patients With Absent Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology"|"The table shows the distribution of lesions according to their specificity and vulvar rings in patients without vulvar dermatosis diagnosed by vulvoscopy (TRIV) and histopathology, as a reference test.~According to the N-S-P scheme, we have set the diagnoses: Normal result (no lesion), Suspect result (non-specific lesion in any of the vulvar rings), and Pathological result (specific for dermatosis in any of the vulvar rings).~Since histopathology can distinguish only patients with and without dermatosis, the distribution was estimated according to these two groups of patients. Hence, patients with normal and suspect vulvoscopic results were classified into one group called Absent Vulvar Dermatosis."|ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.|"Absent Vulvar Dermatosis was diagnosed in 246 patients by vulvoscopy and 256 patients by histopathology. The likelihood of absent vulvar dermatosis was higher as none of the vulvar rings were assessed as P."|||Participants|||Count of Participants
2556018|NCT02732145|Primary|"Distribution of Vulvar Lesions According to the N-S-P Scheme in Patients With Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology"|"The table shows the distribution of vulvoscopy lesions in relation to the vulvar rings and their specificity according to the N-S-P Scheme, in patients with vulvar dermatosis diagnosed by vulvoscopy (TRIV) and histopathology.~Vulvoscopy findings of each of the three vulvar rings: Outer (first letter in the formula), Middle (second letter), and Inner Vulvar Ring (third letter) were evaluated as normal N (absence of any lesions), suspect S (non-specific lesions), or pathological P (lesions specific for dermatosis).~Normal vulvoscopy indicated the absence of any lesion in all three vulvar rings (N-N-N).~Suspect vulvoscopy was used to mark findings of non-specific lesions (S-#*-#; S-S-#; S-S-S; S-N-S etc.).~Pathological vulvoscopy spelled out the finding of lesions specific for dermatosis in any of the three vulvar rings (P-#-#; P-P-; P-P-P; P-N-S etc.).~is the label for any of the three possibilities: N or S or P."|ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.|"Vulvar dermatosis was diagnosed in 82 patients by vulvoscopy and 72 patients by histopathology. The likelihood of vulvar dermatosis was higher as one or more of the vulvar rings were assessed as P."|||Participants|||Count of Participants
2556019|NCT02732145|Primary|"Diagnostic Accuracy of Three Rings Vulvoscopy by the N-S-P Scheme for Detection of Vulvar Dermatosis"|"The distribution of patients with and without vulvar dermatosis diagnosed by vulvoscopy (N-S-P Scheme) and histopathology.~According to the specificity of lesions, vulvoscopy results were classified as normal N (absence of any lesion), suspect S (non-specific lesions) and pathologic P results (lesion specific to dermatosis); and each of the three vulvar rings is represented by a single result.~The final vulvoscopy result is presented in the form of a three-letter formula, where the first letter indicates the vulvoscopy result in the Outer Vulvar Ring, the mean initial indicates the vulvoscopy result of the Middle Vulvar Ring and the last letter denotes the vulvoscopy result of the Inner Vulvar Ring.~N-S-P Scheme divides the results of the vulvoscopy into three groups: Normal Vulvoscopy, Suspect Vulvoscopy and Pathological Vulvoscopy. Diagnosis of vulvar dermatosis was established if one or more vulvar rings showed pathological results (Pathological Vulvoscopy)."|ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.|"Histopathology distinguishes two groups of patients with and without vulvar dermatosis. Therefore the accuracy of the N-S-P Scheme had been estimated according to these two groups of patients."|||Participants|||Count of Participants
2556020|NCT02732145|Primary|"Vulvoscopy Index (Median | Range) in Patients With Absent Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology"|"The table shows the results of Three Rings Vulvoscopy (TRIV) by single categories of the Vulvoscopy Index (median ± SD) in patients with Absent Vulvar Dermatosis diagnosed by TRIV (patients with vulvoscopical diagnoses Normal Vulva, Impaired Vulvar Skin and Vulvodynia) and histopathology.~According to the Vulvoscopy Index, we have set the diagnoses: Normal Vulva (0-2 points), Impaired Vulvar Skin (3-11 points), Vulvodynia (12-18 points), and Vulvar Dermatosis (19-32 points).~The likelihood of the diagnosis of Absent Vulvar Dermatosis was higher as the value of the Vulvoscopy index was lower."|ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.|"Absent Vulvar Dermatosis was diagnosed in 246 patients by vulvoscopy and 256 patients by histopathology."|||units on a scale||Full Range|Median
2556021|NCT02732145|Primary|"Vulvoscopy Index (Median | Range) in Patients With Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology"|"The table shows the results of Three Rings Vulvoscopy (TRIV) by single categories of the Vulvoscopy Index (median ± SD) in patients with Vulvar Dermatosis diagnosed by TRIV and histopathology.~The Vulvoscopy Index is based on five characteristics:~Vulvar complaints (negative=0; positive=4 points),~Marinoff index (negative=0; positive=3 points),~Cotton-Swab test (negative=0; positive=2 points),~Vulvar lesions according to the vulvar rings (Outer Vulvar Ring Lesions=4 points; Middle Vulvar Ring Lesions=2 points and Inner Vulvar Ring Lesions=1 point) and~Specificity of lesions (Non-specific Lesions=2 points; Specific Lesions=14 points).~According to the Vulvoscopy Index, we have set the diagnoses: Normal Vulva (0-2 points), Impaired Vulvar Skin (3-11 points), Vulvodynia (12-18 points), and Vulvar Dermatosis (19-32 points).~The likelihood of the diagnosis of Vulvar Dermatosis was higher as the value of the Vulvoscopy index was higher."|ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.|Vulvar dermatosis was diagnosed in 82 patients by vulvoscopy and 72 patients by histopathology.|||units on a scale||Full Range|Median
2556080|NCT02731469|Secondary|Kel|Elimination rate constant of drug in blood after single injection. In the cohort BCD-131 0,15 mcg/kg due to the absence of a linear terminal elimination phase in volunteers, the calculation of Kel was not possible|0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose|"the calculation of the Kel in group 0,15 mcg/kg was not carried out, due to the lack of a linear terminal phase of elimination in volunteers"|||fraction per hour||Inter-Quartile Range|Median
2556022|NCT02732145|Primary|"Vulvoscopy Index (Mean ± SD) in Patients With Absent Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology"|"The table shows the results of Three Rings Vulvoscopy (TRIV) by single categories of the Vulvoscopy Index (mean± SD) in patients with Absent Vulvar Dermatosis diagnosed by TRIV and histopathology.~According to the Vulvoscopy Index, we have set the diagnoses: Normal Vulva (0-2 points), Impaired Vulvar Skin (3-11 points), Vulvodynia (12-18 points), and Vulvar Dermatosis (19-32 points).~Since histopathology can distinguish only patients with and without vulvar dermatosis, the distribution was estimated according to these two groups of patients. Hence, patients with vulvoscopical diagnoses Normal Vulva, Impaired Vulvar Skin and Vulvodynia were classified into the one group called Absent Vulvar Dermatosis. The likelihood of the diagnosis of Absent Vulvar Dermatosis was higher as the value of the Vulvoscopy index was lower."|ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.|"Absent Vulvar Dermatosis was diagnosed in 246 patients by vulvoscopy and 256 patients by histopathology."|||units on a scale||Standard Deviation|Mean
2556023|NCT02732145|Primary|"Vulvoscopy Index (Mean ± SD) in Patients With Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology"|"The table shows the results of Three Rings Vulvoscopy (TRIV) by single categories of the Vulvoscopy Index (mean ± SD) in patients with Vulvar Dermatosis diagnosed by TRIV and histopathology.~The Vulvoscopy Index is based on five characteristics:~Vulvar complaints (negative=0; positive=4 points),~Marinoff index (negative=0; positive=3 points),~Cotton-Swab test (negative=0; positive=2 points),~Vulvar lesions according to the vulvar rings (Outer Vulvar Ring Lesions=4 points; Middle Vulvar Ring Lesions=2 points and Inner Vulvar Ring Lesions=1 point) and~Specificity of lesions (Non-Specific Lesions=2 points; Specific Lesions=14 points).~According to the Vulvoscopy Index, we have set the diagnoses: Normal Vulva (0-2 points), Impaired Vulvar Skin (3-11 points), Vulvodynia (12-18 points), and Vulvar Dermatosis (19-32 points).~The likelihood of the diagnosis of Vulvar Dermatosis was higher as the value of the Vulvoscopy index was higher."|ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.|Vulvar dermatosis was diagnosed in 82 patients by vulvoscopy and 72 patients by histopathology. The likelihood of vulvar dermatosis was higher as the value of the Vulvoscopy index was higher.|||units on a scale||Standard Deviation|Mean
2556024|NCT02732145|Primary|"Distribution of Patients With Absent Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology According to Single Categories of the Vulvoscopy Index"|"The table shows the distribution of patients with Absent Vulvar Dermatosis diagnosed by Three Rings Vulvoscopy (patients with vulvoscopical diagnoses Normal Vulva, Impaired Vulvar Skin and Vulvodynia) and histopathology, according to single categories of the Vulvoscopy Index.~The five categories within the Vulvoscopy Index are:~Vulvar complaints (present vs. absent),~Marinoff index (positive vs. negative),~Cotton-Swab test (positive vs. negative),~Vulvar lesions according to the vulvar rings (Outer, Middle, and Inner Vulvar Ring Lesion) and~Specificity of lesions (Non-specific and Specific Lesions)."|ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.|"Absent Vulvar Dermatosis was diagnosed in 246 patients by vulvoscopy and 256 patients by histopathology. The likelihood of absent vulvar dermatosis was higher as the value of the Vulvoscopy index was lower."|||Participants|||Count of Participants
2556025|NCT02732145|Primary|"Distribution of Patients With Vulvar Dermatosis Diagnosed by Vulvoscopy (TRIV) and Histopathology According to Single Categories of the Vulvoscopy Index"|"The table shows the distribution of patients with Vulvar Dermatosis diagnosed by Three Rings Vulvoscopy and histopathology according to single categories of the Vulvoscopy Index.~We described five categories within the Vulvoscopy Index:~Vulvar complaints (present vs. absent),~Marinoff index (positive vs. negative),~Cotton-Swab test (positive vs. negative),~Vulvar lesions according to the vulvar rings (Outer, Middle, and Inner Vulvar Ring Lesion) and~Specificity of lesions (Non-specific and Specific Lesions)."|ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.|Vulvar dermatosis was diagnosed in 82 patients by vulvoscopy and 72 patients by histopathology. The likelihood of vulvar dermatosis was higher as the value of the Vulvoscopy index was higher.|||Participants|||Count of Participants
2556026|NCT02732145|Primary|"Diagnostic Accuracy of Three Rings Vulvoscopy by the Vulvoscopy Index for Detection of Vulvar Dermatosis"|"The table shows the distribution of patients with and without vulvar dermatosis diagnosed by Three Rings Vulvoscopy (TRIV) using the Vulvoscopy Index and histopathology as a reference test.~The Vulvoscopy Index as an outcome measure of TRIV is designed as a quantitative test based on five characteristics: vulvar complaints, Marinoff index, Cotton-Swab test, vulvar lesions according to the three vulvar rings and specificity of lesions; with following results: Normal Vulva (0-2 points), Impaired Vulvar Skin (3-11 points), Vulvodynia (12-18 points), and Vulvar Dermatosis (19-32 points).~Since histopathology distinguishes only patients with and without vulvar dermatosis, the clinical value the Vulvoscopy Index had been estimated according to these two groups of patients. Patients with vulvoscopy diagnoses: Normal Vulva, Impaired Vulvar Skin and Vulvodynia were classified into the group Absent Vulvar Dermatosis."|ISSVD Questionnaire and TRIV, up to 75 minutes for each participant.|Vulvar dermatosis was diagnosed in 82 patients by vulvoscopy and 72 patients by histopathology. Absent vulvar dermatosis was found in 246 patients by vulvoscopy and 256 patients by histopathology. The likelihood of vulvar dermatosis was higher as the value of the Vulvoscopy index was higher.|||Participants|||Count of Participants
2556027|NCT02731833|Secondary|Change From Baseline in Tactile Threshold Post First Treatment by Direct Application|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.|Baseline to 60 seconds post first treatment|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||g||Standard Deviation|Mean
2556081|NCT02731469|Secondary|T1/2|Half-life of drug in blood after single injection. In the coрort BCD-131 0,15 mcg/kg due to the absence of a linear terminal elimination phase in volunteers, the calculation of T1 / 2 was not possible|0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose|the calculation of the half-life in group 0,15 mcg/kg was not carried out, due to the lack of a linear terminal phase of elimination in volunteers|||hours||Inter-Quartile Range|Median
2556028|NCT02731833|Secondary|Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline to 60 seconds post first treatment|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||Score on a scale||Standard Deviation|Mean
2556029|NCT02731833|Secondary|Change From Baseline in Tactile Threshold on Day 3|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.|Baseline to Day 3|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||g||Standard Deviation|Mean
2556030|NCT02731833|Primary|Change From Baseline in Schiff Sensitivity Score on Day 3|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline to Day 3|Analysis for this outcome was performed on intent-to-treat (ITT) population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||Score on a scale||Standard Deviation|Mean
2556031|NCT02731820|Primary|"Changes in Serum Levels of Bone-specific Alkaline Phosphatase (BAP) Over Time, i.e. Baseline, 3 Months, 6 Months."|"Bone-specific alkaline phosphatase (BAP) is a specific product of osteoblasts; it is considered as a marker of bone formation. The concentration of BAP (µg/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer's protocol. At the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium citrate versus Placebo (unpaired analysis) and to evaluate the effect of Potassium Citrate and Placebo over time (paired analysis).~Differences will be considered to be statistically significant for p-value <0.05."|Baseline (T0), 3 months (T3) 6 months (T6)|"3/20 patients in the Treatment group did not complete the follow up (n= 1 re-evaluation of the inclusion criteria; n=1 gastritis; n=1 total hip arthroplasty).~2/20 patients in the Placebo group did not complete the follow up (n=2 persistent constipation)"|||µg/L||Standard Error|Mean
2556032|NCT02731820|Primary|"Changes in Serum Levels of N-terminal Propeptide of Type I Procollagen (P1NP) Over Time, i.e. Baseline, 3 Months, 6 Months."|"N-terminal propeptide of type I procollagen (P1NP) is a product of the conversion of procollagen to collagen; it is considered as a marker of bone formation. The concentration of P1NP (pg/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer's protocol. At the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium citrate versus Placebo (unpaired analysis) and to evaluate the effect of Potassium Citrate and Placebo over time (paired analysis).~Differences will be considered to be statistically significant for p-value <0.05."|Baseline (T0), 3 months (T3) 6 months (T6)|"3/20 patients in the Treatment group did not complete the follow up (n= 1 re-evaluation of the inclusion criteria; n=1 gastritis; n=1 total hip arthroplasty).~2/20 patients in the Placebo group did not complete the follow up (n=2 persistent constipation)"|||pg/L||Standard Error|Mean
2556033|NCT02731820|Primary|"Changes in Serum Levels of Tartrate-resistant Acid Phosphatase 5b Isoenzyme (TRAcP5b) Over Time, i.e. Baseline, 3 Months, 6 Months."|"Tartrate-resistant acid phosphatase 5b isoenzyme (TRAcP5b) is a specific product of osteoclasts; it is considered as a marker of bone resorption. The concentration of TRAcP5B (U/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer's protocol. At the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium Citrate versus Placebo (unpaired analysis) and to evaluate the effect of Potassium Citrate and Placebo over time (paired analysis).~Differences will be considered to be statistically significant for p-value <0.05."|Baseline (T0), 3 months (T3) 6 months (T6)|"3/20 patients in the Treatment group did not complete the follow up (n= 1 re-evaluation of the inclusion criteria; n=1 gastritis; n=1 total hip arthroplasty).~2/20 patients in the Placebo group did not complete the follow up (n=2 persistent constipation)"|||U/L||Standard Error|Mean
2556047|NCT02731690|Secondary|Change From Baseline in HHD Muscle Strength in Knee Extensors Over Time|Hand held dynamometry testing was used to measure strength. The maximum voluntary isometric contraction against a dynamometer was used to measure bilateral strength in the following muscle groups: shoulder abductors, wrist extensors and knee extensors. Specialized dynamometers for the measurement of grip and key pinch strength were also used. The total force (in kgf) for each was recorded. Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|Baseline, Weeks 12, 24, 36, and 48|Full Analysis Set: all participants with a baseline measurement and at least 1 postbaseline measurement.|||kgf||95% Confidence Interval|Least Squares Mean
2556183|NCT02729896|Secondary|Percentage of Participants With Best Response of CR or PR During the Study, as Determined by the Investigator on the Basis of CT Scans Alone||Baseline up to approximately 4 years||2021-10-31|10/2021||||
2556034|NCT02731820|Primary|Changes in Serum Level of Carboxyterminal Cross-linked Telopeptide of Type I Collagen (CTX); Over Time, i.e. Baseline, 3 Months, 6 Months.|"Carboxyterminal cross-linked telopeptide of type I collagen (CTX) is a degradation product of the type I collagen; it is considered as a marker of bone resorption. The concentration of CTX (µg/L) will be measured at T0, T3, and T6 on serum samples (fasting morning samples) using commercially available reagents and following the manufacturer's protocol.~At the end of the study, the results will be aggregated as mean ± standard of the mean, median and min-max range. Data will be statistically analyzed in order to compare the activity of Potassium citrate versus Placebo (unpaired analysis) and to evaluate the effect of Potassium Citrate and Placebo over time (paired analysis).~Differences will be considered to be statistically significant for p-value <0.05."|Baseline (T0), 3 months (T3) 6 months (T6)|"3/20 patients in the Treatment group did not complete the follow up (n= 1 re-evaluation of the inclusion criteria; n=1 gastritis; n=1 total hip arthroplasty).~2/20 patients in the Placebo group did not complete the follow up (n=2 persistent constipation)"|||µg/L||Standard Error|Mean
2556035|NCT02731755|Secondary|Renin Activity|Renin activity in ng/(mL*hour)|Acute postprandial timecourse from Baseline, 1hour to 24hours.|Data not collected||||||
2556036|NCT02731755|Secondary|Plasma Insulin|Insulin concentration in pmol/L|Acute postprandial timecourse from Baseline, 1hour to 24hours.|Data not collected||||||
2556037|NCT02731755|Secondary|Plasma Glucose|Glucose concentration in mmol/L|Acute postprandial timecourse from Baseline, 1hour to 24hours.|Data not collected||||||
2556038|NCT02731755|Secondary|NADPH Oxidase Activity in Neutrophil Blood Cells|NADPH oxidase activity will be calculated as the difference between values obtained in PMA The fluorescence intensity was measured by C6 Flow Cytometer|Baseline, 2 hours and 24 hours|Excluded data from 2 volunteers as their results were out of the normal range|||fluorescence intensity||Standard Error|Mean
2556039|NCT02731755|Secondary|Plasma Nitric Oxide Analysis|Concentration of nitric oxide in nmol|Acute postprandial timecourse from Baseline, 1hour to 24hours.|No data collected||||||
2556040|NCT02731755|Secondary|Phenolic Acids Metabolites - Ferulic Acid|Concentration of phenolic acid metabolites in plasma and urine as Assessed by liquid chromatography/mass spectrometry magnitude of increase from Baseline to 24h|Baseline, 1hour, 2 hours and 24hours|Excluded data from 2 volunteers as their results were out of the normal range|||nanomolars||Standard Deviation|Mean
2556041|NCT02731755|Secondary|Laser Doppler Iontophoresis|Acute postprandial timecourse from Baseline to 2 hours, 24hours, AUC - area under the blood flow and time curve Ach-iAUC-endothelium dependent incremental area under the curve SNP-iAUC-endothelium independent incremental area under the curve Ach-AUC- endothelium dependent area under the curve|Baseline(BL), 2hours and 24hours|Excluded data from 2 volunteers as their results were out of the normal range|||PU per hour||Standard Error|Mean
2556042|NCT02731755|Primary|Flow Mediated Dilatation|Technique to assess the flexibility of the endothelium in larger peripheral blood vessels|1 hour, 6 hours and 24 hours|Excluded data from 2 volunteers as their results were out of the normal range|||metre||Standard Error|Mean
2556043|NCT02731742|Primary|Number of Participants Discontinuing Study Drug Due to AEs|The number of participants who discontinued study drug due to an AE is presented.|From first dose of study drug up to last dose of study drug (Up to approximately 9 weeks)|The safety analysis population consisted of all participants who received ≥1 dose of study drug.|||Participants|||Count of Participants
2556044|NCT02731742|Primary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study drug, was also an AE. The number of participants who experienced as AE is presented.|From first dose of study drug through 90 days after last dose of study drug (Up to approximately 22 weeks)|The safety analysis population consisted of all participants who received ≥1 dose of study drug.|||Participants|||Count of Participants
2556045|NCT02731742|Primary|Percentage of Participants With a Dose Limiting Toxicity (DLT)|"The occurrence of any of the following toxicities during Cycle 1 (Days 1-21), if assessed by the Investigator to be possibly, probably or definitely related to MK-1966 or SD-101, was considered a DLT:~Grade (Gr) 4 non-hematologic toxicity;~Gr 4 hematologic toxicity lasting >7 days, except thrombocytopenia: *Gr 4 thrombocytopenia of any duration; *Gr 3 thrombocytopenia if associated with bleeding;~Gr 3 non-hematologic toxicity lasting >3 days despite optimal supportive care;~Any Gr 3 or Gr 4 non-hematologic laboratory abnormality, if: medical intervention is required OR abnormality leads to hospitalization OR abnormality persists for >1 week;~Febrile neutropenia Gr 3 or Gr 4;~Any drug-related AE which caused participant to discontinue study drug during Cycle 1~Gr 5 toxicity; or~Delay in initiation of Cycle 2 for >2 weeks due to study drug-related toxicity. The percentage of participants who experienced a DLT during Cycle 1 is presented."|From time of first dose of study drug to the end of Cycle 1. Each cycle was 21 days. (Up to 21 days)|The DLT evaluable population consisted of all participants who completed study drug in Cycle 1 or discontinued study drug during Cycle 1 due to a DLT.|||Percentage of Participants||80% Confidence Interval|Number
2556046|NCT02731690|Secondary|Change From Baseline in HHD Raw Strength (Key Pinch) Over Time|Hand held dynamometry testing was used to measure strength. The maximum voluntary isometric contraction against a dynamometer was used to measure bilateral strength in the following muscle groups: shoulder abductors, wrist extensors and knee extensors. Specialized dynamometers for the measurement of grip and key pinch strength were also used. The total force (in kgf) for each was recorded.|Baseline, Weeks 12, 24, 36, and 48|Full Analysis Set: all participants with a baseline measurement and at least 1 postbaseline measurement at given time point.|||kgf||Standard Deviation|Mean
2556059|NCT02731690|Secondary|Number of Participants Taking Prior and Concomitant Medications|Prior medications are any medications which started before the date of the first dose of investigational product. Concomitant medications are any medications that are taken on or after the date of the first dose of investigational product excluding concomitant medications started after the date of the last dose of investigational product.|48 weeks|Safety Analysis Set: all enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2556048|NCT02731690|Secondary|Change From Baseline in HHD Raw Strength (Wrist Extensors) Over Time|Hand held dynamometry testing was used to measure strength. The maximum voluntary isometric contraction against a dynamometer was used to measure bilateral strength in the following muscle groups: shoulder abductors, wrist extensors and knee extensors. Specialized dynamometers for the measurement of grip and key pinch strength were also used. The total force (in kgf) for each was recorded. Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|Baseline, Weeks 12, 24, 36, and 48|Full Analysis Set: all participants with a baseline measurement and at least 1 postbaseline measurement.|||kgf||95% Confidence Interval|Least Squares Mean
2556049|NCT02731690|Secondary|Change From Baseline in HHD Raw Strength (Shoulder Abductors) Over Time|Hand held dynamometry testing was used to measure strength. The maximum voluntary isometric contraction against a dynamometer was used to measure bilateral strength in the following muscle groups: shoulder abductors, wrist extensors and knee extensors. Specialized dynamometers for the measurement of grip and key pinch strength were also used. The total force (in kgf) for each was recorded. Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|Baseline, Weeks 12, 24, 36, and 48|Full Analysis Set: all participants with a baseline measurement and at least 1 postbaseline measurement.|||kgf||95% Confidence Interval|Least Squares Mean
2556050|NCT02731690|Secondary|Change From Baseline in HHD Raw Strength (Grip) Over Time|Hand held dynamometry testing was used to measure strength. The maximum voluntary isometric contraction against a dynamometer was used to measure bilateral strength in the following muscle groups: shoulder abductors, wrist extensors and knee extensors. Specialized dynamometers for the measurement of grip and key pinch strength were also used. The total force (in kgf) for each was recorded. Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|Baseline, Weeks 12, 24, 36, and 48|Full Analysis Set: all participants with a baseline measurement and at least 1 postbaseline measurement.|||kgf||95% Confidence Interval|Least Squares Mean
2556051|NCT02731690|Secondary|Change From Baseline in GNEM-FAS Expanded Version Total Scores Over Time|GNEM-FAS Expanded Version Total Score were calculated as the sum of the subscale Scores range from 0 to 120 with higher scores representing greater independence with functional activities. Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|Baseline, Weeks 12, 24, 36, and 48|Full Analysis Set: all participants with a baseline measurement and at least 1 postbaseline measurement.|||units on a scale||95% Confidence Interval|Least Squares Mean
2556052|NCT02731690|Secondary|Change From Baseline in GNEM-FAS Expanded Version Self-Care Domain Subscale Scores Over Time|GNEM-FAS Expanded Version Self-Care subscale scores have 8 items range from 0 to 32 with higher scores representing greater independence with functional care activities. Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|Baseline, Weeks 12, 24, 36, and 48|Full Analysis Set: all participants with a baseline measurement and at least 1 postbaseline measurement.|||units on a scale||95% Confidence Interval|Least Squares Mean
2556053|NCT02731690|Secondary|Change From Baseline in GNEM-FAS Expanded Version Upper Extremity Domain Subscale Scores Over Time|GNEM-FAS Expanded Version Upper Extremity subscale scores have 9 items and range from 0 to 36 with higher scores representing more skilled, independent use of the arms during functional activity performance. Analyzed using a repeated measure GEE model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|Baseline, Weeks 12, 24, 36, and 48|Full Analysis Set: all participants with a baseline measurement and at least 1 postbaseline measurement.|||units on a scale||95% Confidence Interval|Least Squares Mean
2556054|NCT02731690|Secondary|Change From Baseline in GNEM-FAS Expanded Version Mobility Domain Subscale Scores Over Time|GNEM-FAS Expanded Version Mobility subscale scores have 13 items and range from 0 to 52 with higher scores representing greater mobility. Analyzed using a repeated measure generalized estimation equation (GEE) model, which includes the change from baseline as the dependent variable, visit as a fixed factor, and the baseline value as a covariate. Compound symmetry is used as the covariance structure.|Baseline, Weeks 12, 24, 36, and 48|Full Analysis Set: all participants with a baseline measurement and at least 1 postbaseline measurement.|||units on a scale||95% Confidence Interval|Least Squares Mean
2556055|NCT02731690|Secondary|Number of Participants With Overall Suicidal Behaviors and/or Ideation at Baseline and Post-Baseline|As evaluated by the Columbia Suicide Severity Rating Scale (C-SSRS), a participant-rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses).|48 weeks|Safety Analysis Set: all enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2556056|NCT02731690|Secondary|Number of Participants With Clinically Significant Changes From Baseline In Clinical Laboratory Results|The clinical laboratory evaluations performed included serum chemistry, complete blood count (hematology), and urinalysis.|48 weeks|Safety Analysis Set: all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2556057|NCT02731690|Secondary|Number of Participants With Clinically Significant Changes From Baseline In Vital Signs|Vital signs included seated systolic blood pressure and diastolic blood pressure, heart rate, respiration rate, and temperature.|48 weeks|Safety Analysis Set: all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2556058|NCT02731690|Secondary|Number of Participants With Clinically Significant Changes From Baseline In Physical Examinations|Complete physical examinations included assessments of general appearance; head, eyes, ears, nose, and throat; the cardiovascular, dermatologic, lymphatic, respiratory, GI, musculoskeletal, and neurologic systems. The neurologic system examination included assessments of cognition, cranial nerves, motor function, coordination and gait, reflexes, and sensory function. Brief physical examinations included assessments of general appearance, cardiovascular and respiratory systems, and a focus on any presenting complaints.|48 weeks|Safety Analysis Set: all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2556060|NCT02731690|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation|An AE was defined as any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. An SAE or serious suspected adverse reaction is an AE or suspected adverse reaction that at any dose, in the view of either the Investigator or Ultragenyx, results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or disability (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect. TEAEs were defined as any AE that occurred after the first dose of study drug.|48 Weeks (plus 30 [+5] days for participants not enrolling in extension study)|Safety Analysis Set: all enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2556061|NCT02731638|Secondary|Corneal Neovascularization||3 months|This information was not collected and therefore cannot be reported.||||||
2556062|NCT02731638|Secondary|Change in Quality of Life, Measured by the Indian Vision Function Questionnaire (IND-VFQ)||3 months|||||||
2556063|NCT02731638|Secondary|Corneal Topography, as Measured by a Non-contact Imaging Topographer||6 months|||||||
2556064|NCT02731638|Secondary|Corneal Thinning, as Measured by Pachymetry and OCT||6 months|||||||
2556065|NCT02731638|Secondary|Number of Participants With Scar Depth at the Anterior Third, Middle Third, and Posterior Third of the Cornea|Number of participants with scar depth at the anterior third (0-33% depth), middle third (>33-67% depth), and posterior third (>67-100% depth) of the cornea, as measured on slit lamp exam.|3 weeks and 3 months|3-week scar depth data was available for 40 people: 24 in the ISV group (2 lost to follow-up [LTF], 9 unable to assess) and 16 in the Natamycin only group (3 LTF, 16 unable to assess). 3-month scar depth was available for 29 people: 16 in the ISV group (5 LTF, 14 unable to assess) and 13 in the Natamycin only group (7 LTF, 15 unable to assess).|||Participants|||Count of Participants
2556066|NCT02731638|Secondary|Scar Size|Scar size, geometric mean|3 weeks and 3 months|3-week scar size data was available for 42 people: 24 in the ISV group (2 lost to follow-up [LTF], 9 unable to assess) and 18 in the Natamycin only group (3 LTF, 14 unable to assess). 3-month scar size data was available for 29 people: 16 in the ISV group (5 LTF, 14 unable to assess) and 13 in the Natamycin only group (7 LTF, 15 unable to assess).|||millimeters squared||Standard Deviation|Mean
2556067|NCT02731638|Secondary|Best Spectacle-corrected Visual Acuity, as Measured by a Refractionist|Best spectacle-corrected visual acuity using calibrated Original Series Early Treatment Diabetic Retinopathy Study eye charts and recorded as number of letter read.|3 weeks and 3 months|3-week visual acuity data was available for 65 people: 33 in the ISV group (2 lost to follow-up) and 32 in the Natamycin only group (3 lost of follow-up). 3-month visual acuity data was available for 58 people: 30 in the ISV group (5 lost to follow-up) and 28 in the Natamycin only group (7 lost to follow-up).|||logarithm of the minimum angle (logMAR)||Standard Deviation|Mean
2556068|NCT02731638|Primary|Culture Positivity at Day 3 Using Potassium Hydroxide (KOH) Wet Mount to Test for Fungus|Number of of participants with positive fungal cultures at 3 days|3 days|3-day culture results missing for one participant in the Natamycin group|||Participants|||Count of Participants
2556069|NCT02731469|Secondary|Number of Participants With Binding Antibodies to BCD-131|Incidence of Binding antibodies to BCD-131 on Day 50 after a single injection of BCD-131|0, day 50 post-dose||||Participants|||Count of Participants
2556070|NCT02731469|Secondary|Number of Participants With Early Withdrawal Due to AE|Frequency of early withdrawals due to AEs and SAEs|from the first administartion of the drug up to the end of follow up period (28 days after the last dose of the drug)||||Participants|||Count of Participants
2556071|NCT02731469|Secondary|Number of Participants With AE/SAE 3-4 Grade CTCAE|Incidence of Grade 3-4 AEs and SAEs.|from the first administartion of the drug up to the end of follow up period (28 days after the last dose of the drug)||||Participants|||Count of Participants
2556072|NCT02731469|Secondary|Number of Participants With Local Reactions|Incidence of administration site reactions|from the first administartion of the drug up to the end of follow up period (28 days after the last dose of the drug)||||Participants|||Count of Participants
2556073|NCT02731469|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|Total incidence of adverse events (AE)/ serious adverse events (SAE)|from the first administartion of the drug up to the end of follow up period (28 days after the last dose of the drug)||||Participants|||Count of Participants
2556074|NCT02731469|Secondary|Intensity of Pain After Subcutaneous Injection According to Visual Analog Scale|visual analog scale Minimum value - 0, Maximum value -10, Higher scores mean worse outcome|intraoperative|In second period of study, when healthy volunteers received BCD-131 in optimal dose, visual analoge scale was not applied (by protocol)|||score on a scale||Inter-Quartile Range|Median
2556075|NCT02731469|Secondary|AC-Emax - Hemoglobin|Absolute maximum of hemoglobin (AC-Emax - hemoglobin) after single injection of study drug|0, 24 h, 48 h; 72 h; 96 h; 120 h; 168 h; 216 h; 288 h; 336 h, 504 h; 672 h; 840 h; 1008 h; 1176 h post-dose||||gramm per liter||Inter-Quartile Range|Median
2556076|NCT02731469|Secondary|AC-Emax - Reticulocytes|Absolute maximum of reticulocyte count (AC-Emax - reticulocytes) after single injection of study drug|0, 24 h, 48 h; 72 h; 96 h; 120 h; 168 h; 216 h; 288 h; 336 h, 504 h; 672 h; 840 h; 1008 h; 1176 h post-dose||||"10e9 reticulocytes per liter"||Inter-Quartile Range|Median
2556077|NCT02731469|Secondary|AUEC (0-1176 Hours) - Hemoglobin|"Area under effect curve (AUEC) hemoglobin - time from 0 to 1176 hours post-dose after single injection of study drug"|0, 24 h, 48 h; 72 h; 96 h; 120 h; 168 h; 216 h; 288 h; 336 h, 504 h; 672 h; 840 h; 1008 h; 1176 h post-dose||||gr*hr/l||Inter-Quartile Range|Median
2556078|NCT02731469|Secondary|AUEC (0-1176 Hours) - Reticulocytes|"Area under effect curve (AUEC) absolute reticulocyte count - time from 0 to 1176 hours post-dose after single injection of study drug"|0, 24 h, 48 h; 72 h; 96 h; 120 h; 168 h; 216 h; 288 h; 336 h, 504 h; 672 h; 840 h; 1008 h; 1176 h post-dose||||cells (10^9) * hr/l||Inter-Quartile Range|Median
2556079|NCT02731469|Secondary|Clearance of BCD-131|Clearance of BCD-131 in blood after single injection|0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose||||ml per hour||Inter-Quartile Range|Median
2560976|NCT02656290|Other Pre-specified|Subject's Average White Blood Cell Count|Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.|Baseline, 6 months, and annually for up to 5 years|||||||
2556083|NCT02731469|Secondary|Cmax|Maximal concentration of drug in blood after single injection|0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 hours post-dose||||picogram per ml||Inter-Quartile Range|Median
2556084|NCT02731469|Primary|AUC (0-1176 Hours)|"Area under curve (AUC) concentration - time from 0 hours to 1176 hours and to infinity"|0, 15 min, 30 min; 60 min; 2 h, 4 h; 8 h, 24 h, 48 h, 72 h, 96 h, 120 h, 168 h, 216 h, 288 h, 336 h, 504 h, 672 h, 840 h, 1008 h, 1176 h post dose||||pg*hr/ml||Inter-Quartile Range|Median
2556085|NCT02731313|Secondary|Weighted Kappa Coefficient Between Immunohistochemistry (IHC) 4B5 and Silver in Situ Hybridization (SISH) Techniques for HER-2 Testing in Centralized Laboratories|Positive HER-2 status was defined as either immunohistochemistry (IHC) score of 3+ or IHC score 2+/in situ hybridization (ISH) score +, as per the trastuzumab Summary of Product Characteristics (SPC). The HER-2 status in tumor specimens was determined using IHC 4B5 and silver ISH (SISH) in centralized laboratories. The weighted kappa coefficient was used to evaluate the true concordance between the HER-2 status determined by IHC 4B5 and SISH. The weighted kappa coefficient value was interpreted according to the Landis and Koch classification as follows: a) less than (<) 0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|At enrollment|The specimens' population is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion. Here, ‘n’ is number of specimens with available data for this outcome measure.|||weighted kappa coefficient|Participants|95% Confidence Interval|Number
2556086|NCT02731313|Secondary|Cancer Characteristics: Percentage of Participants With Samples in Each of the Tumor-Node-Metastasis (TNM) Stages|The TNM stage system includes information about the size of the primary tumor (T), whether the cancer has spread to nearby lymph nodes (N) and whether the cancer has metastasized to other parts of the body (M). In the T classification TX indicates that the main tumor cannot be measured, T1, T2, T3 and T4 refer to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. In the N classification NX indicates that the cancer in nearby lymph nodes cannot be measured, N0 indicates that there is no cancer in nearby lymph nodes, N1, N2 and N3 refer to the number and location of lymph nodes that contain cancer. The higher the number after the N, the more lymph nodes that contain cancer. In the M classification MX indicates that the metastasis cannot be measured, M0 indicates that the cancer has not spread to other parts of the body and M1 indicates that the cancer has spread to other parts of the body.|At enrollment|The participants’ sub-population being all participants from the specimen population, which is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion. Here, ‘n’ is number of participants with available data for this outcome measure.|||percentage of participants|||Number
2556087|NCT02731313|Secondary|Cancer Characteristics: Percentage of Participants With Samples in Each of the Histologic Type Lauren's Classifications, Including Diffuse Type, Intestinal and Mixed|The Lauren classification is based on examination of histologic specimens under the microscope and divides adenocarcinoma of the stomach into 3 types: 1) Diffuse type: tumor cells are poorly differentiated, behave aggressively and tend to scatter throughout the stomach (rather than form glands). This type metastasizes to other parts of the body much quicker than intestinal type tumors, 2) Intestinal type: tumor cells are well differentiated, grow slowly and tend to form glands, 3) Mixed type: this type is made up of both intestinal and diffuse types.|At enrollment|The participants’ sub-population being all participants from the specimen population, which is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion. Here, ‘n’ is number of participants with available data for this outcome measure.|||percentage of participants|||Number
2556088|NCT02731313|Secondary|Cancer Characteristics: Percentage of Participants With Initial Location of Adenocarcinoma in Stomach Versus Esogastric Location||At enrollment|The participants’ sub-population being all participants from the specimen population, which is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion. Here, ‘n’ is number of participants with available data for this outcome measure.|||percentage of participants|||Number
2556089|NCT02731313|Primary|Simple Kappa Coefficient of Human Epidermal Growth Factor Receptor 2 (HER-2) Status Between Local and Centralized Laboratory Assessments|Positive HER-2 status was defined as either immunohistochemistry (IHC) score of 3+ or IHC score 2+/in situ hybridization (ISH) score +, as per the trastuzumab Summary of Product Characteristics (SPC). The HER-2 status in tumor specimens was determined using the pathologist's choice of IHC and ISH techniques in local laboratories, and using IHC 4B5 and silver ISH (SISH) in centralized laboratories. The kappa coefficient was used to evaluate the true concordance between the HER-2 status determined by local and centralized laboratories. The kappa coefficient value was interpreted according to the Landis and Koch classification as follows: a) less than (<) 0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|At enrollment|The specimens’ population is defined as all specimens for which at least one IHC and/or ISH test was done in the centralized laboratory, without any reasons for exclusion.|||kappa coefficient|Participants|95% Confidence Interval|Number
2556090|NCT02731300|Secondary|Number of Epileptic Discharge After Treatment by tDCS||Baseline, 4 Weeks||||epileptic discharges/30 mins||Standard Deviation|Mean
2556091|NCT02731300|Primary|Number of Seizure After Treatment by tDCS||Baseline, 4 Weeks||||seizures||Standard Deviation|Mean
2556092|NCT02731157|Secondary|Change in p50 Pre- and Post-transfusion||6 months|Data not collected.||||||
2556093|NCT02731157|Secondary|Change in RBC/RBC-MP-mediated Thrombin Generation||6 months|Data not collected.||||||
2556094|NCT02731157|Secondary|Change in RBC Microparticles (MP) Counts||6 months|Data not collected.||||||
2556095|NCT02731157|Secondary|Actual HbA Decrement (g/dl) Without Indexing to Calculated Circulating Blood Volume||6 months|Data not collected.||||||
2556096|NCT02731157|Secondary|Actual HbA Decrement (g/dl) With Indexing to Calculated Circulating Blood Volume||6 months|Data not collected.||||||
2556097|NCT02731157|Primary|Average Percent Hemoglobin (HbA) Decrement Per Day|The %HbA decrement is the current pre-treatment HbA - previous post treatment HbA in %. The average %HbA decrement per day was calculated using matched pairs.|6 months|Each participant acted as their own control with a sequence of rejuvenated and standard exchanges over 6 months. One subject ended further study participation after only 1 rejuvenated RBC exchange; limited data available.|||%HbA per day||Full Range|Mean
2556098|NCT02731131|Secondary|Number of Participants With Negative HDV RNA at End of Treatment|Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at the end of treatment (Week 48) was reported.|Week 48|ITT Population.|||participants|||Number
2556099|NCT02731131|Secondary|Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment|Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at 48 weeks after end of treatment (Week 96) was reported.|Week 96|ITT Population.|||participants|||Number
2556100|NCT02731131|Secondary|Number of Participants With ALT Normalization at End of Treatment|Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). The number of participants with ALT normalization at Week 48 was reported.|Week 48|ITT Population.|||participants|||Number
2556101|NCT02731131|Secondary|Number of Participants With ALT Normalization at 48 Weeks After End of Treatment|Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). The number of participants with ALT normalization at Week 96 was reported.|Week 96|ITT Population.|||participants|||Number
2556102|NCT02731131|Secondary|Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment|Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with ALT normalization and negative HDV RNA at Week 48 was reported.|Week 48|ITT Population.|||participants|||Number
2556103|NCT02731131|Primary|Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment|Normalized ALT was defined as ALT value above the upper limit of normal (ULN) at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). Negative HDV RNA was defined as HDV RNA not detected by polymerase chain reaction (PCR). The number of participants with ALT normalization and negative HDV RNA at Week 96 was reported.|Week 96|ITT Population.|||participants|||Number
2556104|NCT02730988|Secondary|Change in 24-week Lean Mass Body Composition|Lean mass assessed by whole-body DXA and reported in kg|Baseline and 24-weeks|in order to see degree of change, analysis includes participants who obtained DXA scans at both baseline and 24 weeks. Not all participants completed the baseline and final, 24-week follow-up scans.|||kg||95% Confidence Interval|Mean
2556105|NCT02730988|Primary|Change in 400 Meter Gait Walk Speed|Participants were asked to walk 10 laps of a 40-meter course (20 meters out and 20 meters back). The time it took to complete the 400 meters was calculated and reported in meters/second.|baseline and 24 weeks|Number analyzed reflects those who completed both baseline and 24 week followup testing since both trials needed to show change in 400 meter walk distance and speed.|||meters/second||95% Confidence Interval|Mean
2556106|NCT02730871|Secondary|Mean Percentage Change From Baseline in IOP (09:00, 11:00) at Week 6|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. A more negative percentage change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses.|Baseline, Week 6|Full Analysis Set. At each time point, only subjects with a value at both Baseline and that time point are included in the calculation of change.|||percentage change||Standard Deviation|Mean
2556107|NCT02730871|Secondary|Mean Change From Baseline in IOP (09:00, 11:00) at Week 6|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses.|Baseline, Week 6|Full Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included in the calculation of change.|||mmHg||Standard Deviation|Mean
2556108|NCT02730871|Secondary|Mean Percentage Change From Baseline in Diurnal IOP at Week 6|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP percentage change was defined as the average of the two changes from baseline (timepoints 9 AM, 11 AM). A more negative percentage change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses.|Baseline, Week 6|Full Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included in the calculation of change.|||percentage change||Standard Deviation|Mean
2556109|NCT02730871|Secondary|Mean Diurnal IOP at Week 6|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP was defined as the average of the two time points measured (9 AM, 11 AM). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was used for the analyses.|Week 6|Full Analysis Set with non-missing values|||mmHg||Standard Deviation|Mean
2556110|NCT02730871|Primary|Mean Change From Baseline in Diurnal Intraocular Pressure (IOP) (Mean of Changes at 09:00 and 11:00 Time Points) at Week 6|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry. Diurnal IOP change was defined as the average of the two changes from baseline (timepoints 9 AM, 11 AM). A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye (study eye) was used for the analyses.|Baseline, Week 6|Full Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included in the calculation of change.|||mmHg||Standard Deviation|Mean
2556111|NCT02730819|Secondary|Investigator Assessment of Global Improvement From Baseline|The investigator compared the extent of melasma at 20 weeks to a full-face photograph obtained in a standardized manner at baseline. It is a dynamic 7-point scale (0=completely clear to 7=worse).|baseline, 20 weeks|19 participants were enrolled, but 9 participants were lost to follow-up over the course of the study.|||Participants|||Count of Participants
2556549|NCT02722837|Secondary|Percentage of Participants With HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24)|SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2556112|NCT02730819|Secondary|Change in Melasma Quality of Life Scale (MELASQOL)|The Melasma Quality of Life Scale has 10 items, with responses ranging from 0 (no response) to 7 (bothered all the time. The range of possible scores is 0-70, with a higher score indicating a worse melasma-related quality of life.|baseline, 20 weeks|19 participants were enrolled, but 9 participants were lost to follow-up over the course of the study.|||units on a scale||Full Range|Median
2556113|NCT02730819|Primary|Change in Melasma Area and Severity Index (MASI) Score|"Severity of melasma in each of the four regions (forehead, right malar region, left malar region and chin) is assessed on % of the total area involved (A), darkness (D), and homogeneity (H).~Scoring for % area involved: 0=none; 1=<10%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; and 6=90-100%. Darkness scoring (hyperpigmentation): 0=normal skin; 1=barely visible; 2=mild; 3=moderate; 4=severe. Homogeneity scoring: 0=normal skin color; 1=specks of involvement; 2=small patchy areas of involvement <1.5 cm diameter; 3=patches of involvement >2 cm diameter; 4=uniform skin involvement without any clear areas).~To calculate the MASI score, the sum of the severity grade for darkness (D) and homogeneity (H) is multiplied by the numerical value of the areas (A) involved and by the percentages of the four facial areas (10-30%). Total MASI score: Forehead 0.3 (D+H)A + right malar 0.3 (D+H)A + left malar 0.3 (D+H)A + chin 0.1 (D+H)A. The total score can range from 0 (normal) to 48 (severe)."|Baseline, 20 weeks|19 participants were enrolled, but 9 participants were lost to follow-up over the course of the study.|||units on a scale||Full Range|Median
2556114|NCT02730728|Secondary|Patient-oriented Outcomes|Quality of recovery (QoR)-9 score on the second day after surgery. This score is a result of a 9 item questionnaire. Answers to each item/question is scored as (0-1-2). The wort score a patient get in the questionnaire is 0 and the best score is 18, depending on the answer of each of the 9 questions and the sum of the scores of these answers|48 hours||||units on a scale ( QoR score)||Inter-Quartile Range|Median
2556115|NCT02730728|Secondary|Functional Recovery After Surgery|Cumulative ambulation distance in the second postoperative day measured in feet|48 hours|cumulative ambulation distance in second day after surgery|||Feet||Inter-Quartile Range|Median
2556116|NCT02730728|Secondary|Pain Scores at 48 Hours After Surgery|Average pain scores 48 hours after surgery. The scale used is the numeric rating pain scale. The scale values range from 0-10/ where 0 is no pain and 10 is the worst pain possible imagined on this scale|48 hours||||units on a scale ( Pain score)||Standard Deviation|Mean
2556117|NCT02730728|Primary|Patients With Severe Pain at 48 Hours After Surgery|The proportion of patients reporting severe pain, defined as pain score (7-10) through the second postoperative day|48 hours||||percentage of patients with severe pain|||Number
2556118|NCT02730663|Secondary|Other Adverse Events|The severity and incidence of all other adverse events than those mentioned above occurred during the follow-up period were evaluated at Day 20 day after the stent removal.|up to 90 days (at Day 20 post stent removal)|The severity and incidence of all other adverse events than those mentioned above occurred during the follow-up period were evaluated at Day 20 day after the stent removal.|||case|||Number
2556119|NCT02730663|Secondary|Number of Participants With Procedural/Device Related Serious Adverse Events|The incidence of serious adverse events related to the procedure or the Niti-S SPAXUSTM stent is assessed at Day 20 after the stent removal|up to 90 days (at Day 20 post stent removal)|"Resulted in death or life threatening~Required inpatient hospitalization or prolongation of existing hospitalization ③ Resulted in persistent or significant disability/incapacity ④ Caused a congenital anomaly/birth defect"|||participants|||Number
2556120|NCT02730663|Secondary|Procedure Time|Procedure time is measured as time from insertion until removal of endoscope. Procedure time 1: The time from the moment that the endoscope is inserted into the oral cavity to the time point at which the endoscope is removed. (sec) Procedure time 2: The time from the puncture time to the point at which the ultrasound endoscope was removed. (sec)|1 day|The time is measured from the moment that the endoscope is inserted into the oral cavity to the time point at which the endoscope is removed.|||sec||Standard Deviation|Mean
2556121|NCT02730663|Secondary|Number of Participants With Stent Removal Success|Stent removal success is defined as successful removal of the Niti-S SPAXUS stent using a standard endoscopic forceps or snare.|up to 60 days (at stent removal, Day 30 or 60)|When the Niti-S SPAXUSTM Stent is successfully removed by using forceps or snare through endoscopy as the treatment is succeeded clinically at Day 30 or 60 (± 10 days) according to standard procedures and the criteria for stent removal are met, it is considered as the stent removal success.|||Participants|||Count of Participants
2556122|NCT02730663|Secondary|Number of Participants With Stent Lumen Patency|Stent lumen patency will be evaluated by endoscopy.|up to 60 days (at stent removal, Day 30 or 60)|The stent lumen patency will be evaluated by the investigator at Day 30 or 60 (± 10 days) after the procedure of the Niti-S SPAXUS stent through clinical symptoms and endoscopy.|||Participants|||Count of Participants
2556123|NCT02730663|Secondary|Number of Participants With Technical Success|Technical success is defined as successful placement of the Niti-S SPAXUS stent across the gastric(or duodenal) wall to the pseudocyst with visualization of the pseudocyst fluid drainage through the stent by endoscopy.|Day 1|If the stent is deployed successfully in the gastrointestinal tract and the pseudocyst, and if the drainage is confirmed visually, it is considered technically successful|||Participants|||Count of Participants
2556124|NCT02730663|Primary|Number of Participants With Clinical Success|Clinical success is defined as ≥50% decrease in pancreatic pseudocyst size measured on Computed Tomography (CT)|at stent removal (Day 30 or Day 60)|The analysis is performed in the subjects who underwent the Niti-S SPAXUS stent and have the results of effectiveness assessment at the time point of the stent removal among those who satisfy the inclusion • exclusion criteria, consented to participate in the study|||participants|||Number
2556125|NCT02730598|Secondary|Change in Stair Climb Time.|Average time of two trials used for each participant.|Baseline and 12-week follow-up||||seconds||Standard Deviation|Mean
2556126|NCT02730598|Secondary|Change in 5-chair Stand Time.|Average time of two trials used for each participant.|Baseline and 12-week follow-up||||seconds||Standard Deviation|Mean
2556127|NCT02730598|Secondary|Change in 20-meter Walk Time.|Average time of two trials used for each participant.|Baseline and 12-week follow-up||||seconds||Standard Deviation|Mean
2556550|NCT02722837|Secondary|Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2556128|NCT02730598|Secondary|Change in Quality of Life (QOL) Assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS)|The Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) subscale was used at baseline and follow-up to assess participant outcomes. The QOL subscale is made up of 4 questions and was scored from zero to 100, with zero corresponding to extreme knee problems and 100 corresponding to no knee problems.|Baseline and 12-week follow-up||||units on a scale||Standard Deviation|Mean
2556129|NCT02730598|Secondary|Change in Knee Pain Assessed by Knee Injury and Osteoarthritis Outcome Score (KOOS)|The Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale was used at baseline and follow-up to assess participant outcomes. The pain subscale is made up of 9 questions and was scored from zero to 100, with zero corresponding to extreme knee problems and 100 corresponding to no knee problems.|Baseline and 12-week follow-up||||units on a scale||Standard Deviation|Mean
2556130|NCT02730598|Secondary|Change in Knee Pain Assessed by a Visual Analog Scale (VAS)|Knee pain will be evaluated using a visual analog scale (VAS) of 100 mm from no pain (0 mm) to the worst imaginable pain (100 mm). Participants will be asked to record their pain levels of the past one week.|Baseline and 12-week follow-up||||millimeters (mm)||Standard Error|Least Squares Mean
2556131|NCT02730598|Secondary|Change in Knee Flexor Strength Assessed by Isokinetic Dynamometer|Participants will be familiarized with strength testing equipment and counseled on proper lifting technique. They will undergo testing to determine their peak isokinetic knee flexor torque, using an isokinetic dynamometer.|Baseline and 12-week follow-up||||Newton-meters (Nm)||Standard Deviation|Mean
2556132|NCT02730598|Primary|Change in Knee Extensor Strength Assessed by Isokinetic Dynamometer.|Participants will be familiarized with strength testing equipment and counseled on proper lifting technique. They will undergo testing to determine their peak isokinetic knee extensor torque, using an isokinetic dynamometer.|Baseline and 12-week follow-up||||Newton-meters (Nm)||Standard Error|Least Squares Mean
2556133|NCT02730455|Secondary|Percentage of Participants With Dose Response at Day 90|Percentage of participants with dose response was evaluated in proportion of excellent outcome on mRS and BI.|Day 90|MITT population: all randomized participants who had received entire infusion of study treatment. Participants who were accidentally enrolled based on conditions that mimicked stroke symptom at presentation were excluded from MITT population. Number analyzed is number of participants with data available for analysis.|||percentage of participants|||Number
2556134|NCT02730455|Secondary|Number of Participants Experiencing Serious Adverse Events (SAE)|A SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization, results in a significant disability/incapacity or congenital anomaly.|Baseline up to Day 90|The safety population was defined as participants who had received any study treatment, including cases of complete or incomplete infusion.|||participants|||Number
2556135|NCT02730455|Secondary|Number of Participants Experiencing Adverse Events (AE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Baseline up to Day 90|The safety population was defined as participants who had received any study treatment, including cases of complete or incomplete infusion.|||participants|||Number
2556136|NCT02730455|Secondary|Change From Baseline in National Institute of Health Stroke Scale (NIHSS) Score at Day 90|The NIHSS is a reliable tool for rapidly evaluating the effects of acute cerebral infarction. A trained observer rates the participant's ability to answer questions and perform activities relating to level of consciousness, language, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, sensory loss, and extinction and inattention (formerly neglect). There are 15 items. Total score ranges from 0 as normal to a maximum possible total severity score of 42 for all items. Higher the score, more the severity. A negative change from Baseline indicates improvement.|Baseline, Day 90|MITT population: all randomized participants who had received entire infusion of study treatment. Participants who were accidentally enrolled based on conditions that mimicked stroke symptom at presentation were excluded from MITT population. Number analyzed is number of participants with data available for analysis.|||score on a scale||Standard Deviation|Mean
2556137|NCT02730455|Secondary|Montreal Cognitive Assessment (MoCA) Score at Day 90|The MoCA is a global cognitive screening test with favorable psychometric properties It screens 8 domains: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 0 to 30 points; a score of 26 or above is considered normal, <10 (severe cognitive impairment), 10-17 (moderate cognitive impairment) and >=18 (mild cognitive impairment).|Day 90|MITT population: all randomized participants who had received entire infusion of study treatment. Participants who were accidentally enrolled based on conditions that mimicked stroke symptom at presentation were excluded from MITT population. Number analyzed is number of participants with data available for analysis.|||score on a scale||Standard Deviation|Mean
2556138|NCT02730455|Secondary|Stroke Impact Scale-16 (SIS-16) Score Using a Repeated Measures Mixed Effects Model at Day 90|The SIS-16 is a 16-item physical dimension instrument that was developed as a brief, stand-alone tool for measuring the physical aspects of stroke recovery. The 16 physical aspects are rated on a 1 to 5 scale as follows: not difficult at all (5), a little difficult (4), somewhat difficult (3), very difficult (2), and could not do at all (1). Total score range is 16 to 80, with higher scores indicating higher levels of health-related quality of life and function.|Day 90|MITT population: all randomized participants who had received entire infusion of study treatment. Participants who were accidentally enrolled based on conditions that mimicked stroke symptom at presentation were excluded from MITT population. Number analyzed is number of participants with data available for analysis.|||score on a scale||Standard Deviation|Mean
2556184|NCT02729896|Secondary|Percentage of Participants With Objective Response (CR + PR) at EOI, as Determined by the Investigator on the Basis of CT Scans Alone||Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months)|Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available|||Percentage of participants|||Number
2556551|NCT02722837|Primary|Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event||Up to 12 weeks|Safety analysis Set|||percentage of participants|||Number
2556139|NCT02730455|Secondary|Percentage of Participants With Excellent Outcome in BI Score at Day 90|"Excellent BI outcome is defined as a score of >=95. BI consists of 10 items that measure a participant's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and returning, grooming, transferring to and from a toilet, bathing, walking on a level surface, going up and down stairs, dressing, and maintaining continence of bowels and bladder. The scores for each of the items are summed to create a total score of 0 to 100. The higher the score, the more independent the participant is."|Day 90|MITT population: all randomized participants who had received entire infusion of study treatment. Participants who were accidentally enrolled based on conditions that mimicked stroke symptom at presentation were excluded from MITT population. Number analyzed is number of participants with data available for analysis.|||percentage of participants|||Number
2556140|NCT02730455|Secondary|Percentage of Participants With Excellent Outcome in mRS Score at Day 90|Excellent mRS is defined as mRS score of 0 or 1. mRS measures independence, rather than neurological function, with specific tasks pre- and poststroke. The scale consists of 7 grades, from 0 to 6, with 0 corresponding to no symptoms and 6 corresponding to death.|Day 90|MITT population: all randomized participants who had received entire infusion of study treatment. Participants who were accidentally enrolled based on conditions that mimicked stroke symptom at presentation were excluded from MITT population. Number analyzed is number of participants with data available for analysis.|||percentage of participants|||Number
2556141|NCT02730455|Primary|Percentage of Participants With Composite Global Measure of Functional Disability Excellent Outcome at Day 90|"The composite global measure of functional disability excellent outcome was based on a score of 0 or 1 on the modified Rankin Scale (mRS) and a score of >=95 on the Barthel Index (BI). mRS measures independence, rather than neurological function, with specific tasks pre- and post-stroke. The scale consists of 7 grades, from 0 to 6, with 0 corresponding to no symptoms and 6 corresponding to death. BI consists of 10 items that measure a participant's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and returning, grooming, transferring to and from a toilet, bathing, walking on a level surface, going up and down stairs, dressing, and maintaining continence of bowels and bladder. The scores for each of the items are summed to create a total score of 0 to 100. The higher the score, the more independent the participant is."|Day 90|Modified Intent-to-Treat (MITT) population: all randomized participants who had received entire infusion of study treatment. Participants who were accidentally enrolled based on conditions that mimicked stroke symptom at presentation were excluded from MITT population. Number analyzed is the number of participants with data available for analysis.|||percentage of participants|||Number
2556142|NCT02730403|Primary|Days of Opioid Use|Days of use up 8 weeks post discharge|Up to Week 8 Post Discharge||||days||Standard Deviation|Mean
2556143|NCT02730403|Primary|Time to Regular Use|Days to regular opioid use from Timeline Followback|Up to Week 8 Post Discharge|Patients admitted to detoxification or short term residential programs associated with CTN-0051 for OUD|||days||Standard Deviation|Mean
2556144|NCT02730403|Primary|Time to First Use|Days to first opioid use from Timeline Followback|Up to Week 8 Post Discharge|Patients admitted to detoxification or short term residential programs associated with CTN-0051 for OUD|||days||Standard Deviation|Mean
2556145|NCT02730403|Primary|Positive UDSs at Week 8|Number of positive UDSs at Week 8|week 8||||Participants|||Count of Participants
2556146|NCT02730403|Primary|Negative UDSs at Week 8|Number of negative UDSs at Week 8|week 8||||Participants|||Count of Participants
2556147|NCT02730403|Primary|Missing UDSs at Week 8|Number of missing UDSs at Week 8|week 8||||Participants|||Count of Participants
2556148|NCT02730403|Primary|Negative UDSs at Week 4|Number of negative UDSs at Week 4|week 4||||Participants|||Count of Participants
2556149|NCT02730403|Primary|Positive UDSs at Week 4|Number of positive UDSs at Week 4|week 4||||Participants|||Count of Participants
2556150|NCT02730403|Primary|Missing UDSs at Week 4|Number of missing UDSs at Week 4|week 4||||Participants|||Count of Participants
2556151|NCT02730403|Primary|Missing UDSs at Week 1|Number of missing UDSs at Week 1|week 1||||Participants|||Count of Participants
2556152|NCT02730403|Primary|Negative UDSs at Week 1|Number of negative UDSs at Week 1|week 1||||Participants|||Count of Participants
2556153|NCT02730403|Primary|Positive Urine Drug Screen (UDS) at Week 1|Number of positive UDSs at Week 1|week 1||||Participants|||Count of Participants
2556154|NCT02730403|Primary|Days of Opioid Use|Days of use during the first 4 weeks post discharge|Up to Week 4 Post Discharge||||days||Standard Deviation|Mean
2556155|NCT02730351|Secondary|Weighted Mean 0-60 Min for Percentage Decrease From Pre-exercise FEV1 Following Exercise Challenge at 12 Hrs and 23 Hrs Post Evening Dose.|The exercise challenge testing at the end of 2 week treatment period was performed on a treadmill at 12 hrs and 23 hrs after administration of the evening dose of double-blind treatment. Following exercise challenge testing, post-exercise FEV1 values were assessed serially at 5, 10, 15, 30, 45 and 60 min. Pre-exercise FEV1 was defined as the FEV1 value collected prior to the exercise challenge test at 23 hrs post-dose. Number of participants listed is the number in the ITT population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|At Week 2 of treatment period 1 and 2|ITT Population. Participants with non-missing covariates and data specific to endpoint were analyzed|||Percentage of FEV1||Standard Error|Least Squares Mean
2556156|NCT02730351|Secondary|Proportion of Participants With a 30 Min Post-challenge FEV1 no More Than 5 Percent Lower Than Pre-exercise FEV1 Following the Exercise Challenge at 12 Hrs and 23 Hrs Post Evening Dose.|The blinded treatment exercise challenge test was performed at the end of 2-weeks of treatment period 1 and treatment period 2 on a treadmill at 12 hrs and 23 hrs after administration of the evening dose of study treatment. The challenge was followed immediately by serial assessments of FEV1 at 5, 10, 15, 30, 45 and 60 min post-exercise. Pre-exercise FEV1 was defined as the FEV1 value collected prior to the exercise challenge test at 23 hrs post-dose. Number of participants listed is the number in the ITT population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|At Week 2 of treatment period 1 and 2|ITT Population. Participants with non-missing covariates and data specific to endpoint were analyzed|||Participants|||Number
2556157|NCT02730351|Secondary|Maximal Percent Decrease in FEV1 Following Exercise Challenge at 23 Hrs Post Evening Dose From Pre-exercise FEV1.|The exercise challenge test is a stepped challenge on a treadmill. It was performed at 23 hrs post evening dose at the end of the 2-week treatment period, wherein the participants exercised sufficiently to reach a heart rate between 80 to 95 percent of their predicted maximum within 4 min and maintained the heart rate with exercise for an additional 6 min followed immediately by serial assessments of FEV1 at 5, 10, 15, 30, 45 and 60 min post-exercise. Maximal percent decrease was calculated as pre-exercise FEV1 minus minimum post exercise FEV1 (smallest FEV1 value collected within one hr following exercise challenge) divided by pre-exercise FEV1 multiplied by 100. Pre-exercise FEV1 was defined as the FEV1 collected prior to the exercise challenge test at 23 hr post dose.|At Week 2 of treatment period 1 and 2|ITT Population. Participants with non-missing covariates and data specific to endpoint were analyzed|||Percentage of FEV1||Standard Error|Least Squares Mean
2556158|NCT02730351|Primary|Maximal Percent Decrease in Forced Expiratory Volume in One Second (FEV1) Following Exercise Challenge at 12 Hours (Hrs) Post Evening Dose From Pre-exercise FEV1.|The exercise challenge test is a stepped challenge on a treadmill. It was performed at 12 hrs post evening dose at the end of the 2-week treatment period, wherein the participants exercised sufficiently to reach a heart rate between 80 to 95 percent of their predicted maximum within 4 minutes (min) and maintained the heart rate with exercise for an additional 6 min followed immediately by serial assessments of FEV1 at 5, 10, 15, 30, 45 and 60 min post-exercise. Maximal percent decrease was calculated as pre-exercise FEV1 minus minimum post exercise FEV1 (smallest FEV1 value collected within one hr following exercise challenge) divided by pre-exercise FEV1 multiplied by 100. Pre-exercise FEV1 was defined as the FEV1 collected prior to the exercise challenge test at 12 hr post dose. ITT Population comprised of all participants randomized to treatment and who received at least one dose of study medication.|At Week 2 of treatment period 1 and 2|ITT Population. Participants with non-missing covariates and data specific to endpoint were analyzed|||Percentage of FEV1||Standard Error|Least Squares Mean
2556159|NCT02730260|Primary|Smoking Abstinence for 7 Days at Last Contact|By self report, the participant has smoked no cigarettes in the past 7 days on the date of last post-intervention assessment, which occurs 6 to 12 months after enrollment.|6-12 months|These are participants who were successfully contacted at 6 or 12 months following enrollment. Other participants are counted as continuing smokers.|||participants|||Number
2556160|NCT02730208|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)||Day 1 up to Week 76|Safety set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2556161|NCT02730208|Primary|Absolute Change in Total Brody/CF-CT Score|The exploratory Brody/CF-CT score semi-quantitatively scores the degree of structural lung disease as shown on CT in participants with CF. The score ranges from a minimum of 0 to a maximum of 219 with higher scores indicating more severe structural lung disease.|From Baseline at Week 72|FAS included all participants who were randomized and received at least 1 dose of study drug.|||scores on a scale||Standard Error|Least Squares Mean
2556162|NCT02730195|Secondary|Proportion of Subjects Who Lose MMR Following Discontinuation of Pioglitazone and TKI Using Blood qRT-PCR for BCR-ABL1|The proportion of subjects that has reappearance of BCR-ABL1 will be described. Descriptive statistics that will summarize the changes in BCR-ABL1 testing over time will be presented. Loss of MMR is defined as a BCR-ABL1 > 0.1% by qRT-PCR confirmed within a week and associated with a rise in the titer on a confirmatory test obtained 4 weeks later (European Leukemia Net definition). Subgroup analyses will be performed by baseline potential prognostic factors. Subgroups will include: age, gender, race, underlying diagnosis, and other disease-related prognostic factors (disease status).|Up to 3 years||||Participants|||Count of Participants
2556163|NCT02730195|Primary|Proportion of Subjects Who Achieve and Maintain Major Molecular Response (MMR) Following a Second Discontinuation of TKI Using Blood Quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) for Breakpoint Cluster Region-Abelson1 (BCR-ABL1)|The proportion of subjects that has reappearance of BCR-ABL1 will be described. Descriptive statistics that will summarize the changes in BCR-ABL1 testing over time will be presented. Subgroup analyses will be performed by baseline potential prognostic factors. Subgroups will include: age, gender, race, underlying diagnosis, and other disease-related prognostic factors (disease status).|Up to 6 months||||Participants|||Count of Participants
2556164|NCT02730195|Primary|Incidence of Adverse Events (AEs), Graded According to Common Terminology Criteria for Adverse Events Version 4.03|The AE incidence will be described. An AE is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. AEs will be assessed through scheduled assessments and subject reported diaries.|Up to 30 days after the end of treatment||||events|||Number
2556165|NCT02730130|Secondary|Time to Response|Only participants with a Complete Response and a Partial Response will be evaluated.|13 weeks||||months||Full Range|Median
2556166|NCT02730130|Secondary|Duration of Response|Only participants with a Complete Response and a Partial Response will be evaluated.|13 weeks||||months||Full Range|Median
2556167|NCT02730130|Primary|Overall Response Rate in Unirradiated Lesions|RECIST v. 1.1 criteria will be used.|13 weeks||||Participants|||Count of Participants
2556168|NCT02729909|Secondary|Weekly Abdominal Symptoms Score|Weekly abdominal symptoms of bloating and discomfort upon waking in the morning was scored weekly on a 5-point scale where: 0=None, 1=Mild, 2=Moderate, 3=Severe or 4=Very severe, with a higher score indicating more severe symptoms. Assessment of weekly abdominal symptoms were recorded in the participant in the diary.|Weeks 1, 2, 3 and 4|FAS included all participants randomized to receive study treatment whether or not they received treatment. Missing values were imputed by using LOCF.|||score on a scale||Standard Deviation|Mean
2556185|NCT02729896|Secondary|Percentage of Participants With Objective Response (CR + PR) at EOI, as Determined by the Investigator on the Basis of PET-CT Scans||Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months)|Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available|||Percentage of participants|||Number
2556560|NCT02722330|Secondary|Free Field - Speech Recognition in Quiet, Investigational Device vs Softband|Change of hearing performance free field - speech recognition in quiet from the situation with the same sound processor on a Baha Softband with the Investigational device on the attract system at 12 weeks|12 weeks||||dB||Standard Deviation|Mean
2556169|NCT02729909|Secondary|Mean Degree of Stool Consistency|For each participant, the mean stool consistency score was averaged for all SBMs in a given week. The mean degree of stool consistency for each SBM was collected in the participant diary based on the Bristol Stool Chart. The Bristol Stool Chart is a medical aid designed to classify the form of human feces into seven categories where: 1=Hard and round (difficult-to-pass), 2=Sausage-shaped but hard stool, 3=Sausage-shaped stool with cracks on the surface, 4=Sausage-shaped, soft stool with smooth surface, or coiled stool, 5=Soft, half-solid (and easy-to-pass) stool with clear crease, 6=Unshaped, loose stool with small, irregular-shaped pieces, or mushy stool or 7=Watery stool without solid pieces (entirely liquid).|Weeks 1, 2, 3 and 4|FAS included all participants randomized to receive study treatment whether or not they received treatment. Missing values were imputed by using LOCF.|||score on a scale||Standard Deviation|Mean
2556170|NCT02729909|Secondary|Mean Degree of Straining Score|For each participant, the mean degree of straining was averaged for all SBMs in a given week. The degree of straining for each SBM was collected in the participant diary. The degree of straining was scored on a 5-point scale where: 0=No straining, 1=Mild straining, 2=Moderate straining, 3=Strong straining or 4=Very strong straining with higher scores indicating more severe straining.|Weeks 1, 2, 3 and 4|FAS included all participants randomized to receive study treatment whether or not they received treatment. Missing values were imputed by using LOCF.|||score on a scale||Standard Deviation|Mean
2556171|NCT02729909|Secondary|Percentage of Participants Who Have a SBM Within 24 Hours After First Dose of Study Medication|A SBM is defined as any BM that does not occur within 24 hours after rescue medication use. Percentage of participants who have an SBM within 24 hours after the first dose was assessed and derived from the data on SBMs collected in the participant diary.|Up to 24 hours after the first dose of study medication|FAS included all participants randomized to receive study treatment whether or not they received treatment.|||percentage of participants|||Number
2556172|NCT02729909|Secondary|SBM Frequency at Weeks 2, 3 and 4|A SBM is defined as any BM that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants were given a diary to complete at home where they have recorded all details of each SBM including the consistency of the stool and the difficulty they have in passing it.|Weeks 2, 3 and 4|FAS included all participants randomized to receive study treatment whether or not they received treatment. Missing values were imputed by using LOCF.|||number of SBM per week||Standard Deviation|Mean
2556173|NCT02729909|Primary|Spontaneous Bowel Movement (SBM) Frequency at Week 1 of Administration|A SBM is defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants were given a diary to complete at home where they have recorded all details of each SBM including the consistency of the stool and the difficulty they have in passing it.|Week 1|Full Analysis Set (FAS) included all participants randomized to receive study treatment whether or not they received treatment. Missing values were imputed by using last observation carried forward (LOCF).|||number of SBM per week||Standard Deviation|Mean
2556174|NCT02729896|Secondary|Incidence of ATAs to Pola|Pre-dose (0 hr) on Day 1 of Cycle 1, 2, 4, anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to approximately 4 years (1 cycle=21 days; infusion rate: starts with 90 min and decreases to 30 min)|Baseline to approximately 4 years||2020-10-31|10/2020||||
2556175|NCT02729896|Secondary|Incidence of Anti-Therapeutic Antibodies (ATAs) to Atezo|Pre-dose (0 hr) on Day 1 of Cycle 2, 3, 4, 6, Month 1, 4, 7, 13 and 19, anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to approximately 4 years (1 cycle=21 days; infusion rate: starts with 60 min and decreases to 30 min)|Baseline to approximately 4 years||2020-10-31|10/2020||||
2556176|NCT02729896|Secondary|Incidence of Human Anti-Chimeric Antibodies (HACAs) to Rituximab|Pre-dose (0 hr) on Day 1 of Cycle 1, 2, 4, 6, anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to approximately 4 years (1 cycle=21 days; infusion rate: starts with 50 mg/hr and increased every 30 min to maximum of 400 mg/hr)|Baseline to approximately 4 years||2020-10-31|10/2020||||
2556177|NCT02729896|Secondary|Incidence of Human Anti-Human Antibodies (HAHAs) to Obinutuzumab|Pre-dose (0 hr) on Day 1 of Cycle 1, 6, anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to approximately 4 years (1 cycle=21 days; infusion rate: starts with 50 mg/hr and increased every 30 min to maximum of 400 mg/hr)|Baseline up to approximately 4 years||2020-10-31|10/2020||||
2556178|NCT02729896|Secondary|Serum Pola Concentration|pre-dose (0 hr) on Day 1 Cycle 1; pre-dose (within 5 hr) on Day 1 of Cycles 2, 4; maintenance phase: pre-dose (within 5 hr) on Day 1 of Months 1; anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to approximately 4 years (1 cycle=21 days; infusion rate: starts with 90 min and decreases to 30 min)|Pre-dose (0 hr) up to approximately 4 years||2020-10-31|10/2020||||
2556179|NCT02729896|Secondary|Serum Atezo Concentration|pre-dose (within 5 hr), 30 min after EOI on Day 1 of Cycles 2, 3, 4; pre-dose (within 5 hr) on Day 1 of Cycle 6; maintenance phase: pre-dose (within 5 hr) on Day 1 of Month 1; 30 min after EOI on Day 2 of Month 1; pre-dose (within 5 hr) on Day 1 of Month 4, 7, 13, 19; anytime during treatment discontinuation visit, 120 days after the last dose, and 1-2 years after the last dose up to approximately 4 years (1 cycle=21 days; infusion rate: starts with 60 min and decreases to 30 min)|Pre-dose (0 hr) up to approximately 4 years||2020-10-31|10/2020||||
2556180|NCT02729896|Secondary|Serum Rituximab Concentration|pre-dose (0 hr), 30 min after EOI on Day 1 Cycle 1; pre-dose (within 5 hr) on Day 1 of Cycles 2, 4; pre-dose (within 5 hr), 30 min after EOI on Day 1 of Cycle 6; anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to approximately 4 years (1 cycle=21 days; infusion rate: starts with 50 mg/hr and increases every 30 min to maximum of 400 mg/hr)|Pre-dose (0 hr) up to approximately 4 years||2020-10-31|10/2020||||
2556181|NCT02729896|Secondary|Serum Obinutuzumab Concentration|pre-dose (0 hr), 30 min after EOI on Day 1 Cycle 1; pre-dose (within 5 hr), 30 min after EOI on Day 1 of Cycles 2, 4, 6; maintenance phase: pre-dose (within 5 hr) on Day 1 of Months 1, 7, 13, 19; anytime during treatment discontinuation visit, 120 days after the last dose, and 1 year after the last dose up to approximately 4 years (1 cycle=21 days; infusion rate: starts with 50 mg/hr and decreases every 30 min to maximum of 400 mg/hr)|Pre-dose (0 hr) up to approximately 4 years||2020-10-31|10/2020||||
2556182|NCT02729896|Secondary|Percentage of Participants With Adverse Events and Serious Adverse Events||Baseline up to approximately 4 years||2021-10-31|10/2021||||
2556186|NCT02729896|Secondary|Percentage of Participants With CR at EOI, as Determined by Investigator on the Basis of CT Scans Alone|Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT scan. OR: a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes & extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR with a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population|Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months)|Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available.|||Percentage of participants|||Number
2556187|NCT02729896|Primary|Percentage of Participants With CR at EOI, as Determined by the Investigator on the Basis of Positron Emission Tomography and Computed Tomography (PET-CT) Scan|Tumor response assessment was performed by the investigator according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. 90% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.|Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 6 months)|Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available.|||Percentage of participants|||Number
2556188|NCT02729831|Secondary|Surgical Rates|Medical chart review and patient report of whether or not surgery was used in the 6 months after the visit.|6 months after the initial visit|Excluding patients who did not provide information to calculate the Informed, Patient-Centered (IPC) variable.|||Participants|||Count of Participants
2556189|NCT02729831|Secondary|Change in Quality of Life|Overall quality of life (EQ-5D) scores will be calculated and the impact of decision support strategies on change in quality of life will be examined. Scale ranges from -0.11 to 1.00, with higher (positive) values meaning better overall health. The minimum important change is 0.10 points.|before orthopedic visit; 12 months from date of orthopedic visit|Participants must answer all 5 items of the EQ-5D measure from the Baseline and 6 months follow-up survey. Only 868/1124 participants provided sufficient information at both time points to calculate a change in quality of life score.|||units on a scale||Standard Deviation|Mean
2556190|NCT02729831|Secondary|Percentage of Participants Who Used the Decision Aid|1 item asking patients how much they reviewed the program (none, some, most, all). The percentage who report viewing most or all will be calculated.|before orthopedic visit|Participants must answer the program usage question on the Baseline survey. Only 1091/1124 participants provided sufficient information to calculate decision aid usage.|||Participants|||Count of Participants
2556191|NCT02729831|Primary|Percentage of Patients Who Received Preferred Treatment|Patient preferred treatment item from the Hip or Knee Decision Quality Instrument will be compared with the treatment received to determine percentage of patients who received treatment that matched their preferences.|1 week after visit with orthopedic surgeon|Participants must complete the 1 week survey and answer the treatment preference question. Only 956/967 participants provided sufficient information to calculate a treatment match.|||Participants|||Count of Participants
2556192|NCT02729831|Primary|Patients Knowledge|Knowledge sub-score generated from responses to the Hip or Knee Decision Quality Instrument (DQI). Scores range from 0-100%, with higher score meaning higher knowledge.|before orthopedic visit|There were a total of 5 hip and knee specific knowledge questions in the DQI. Participants must answer at least 3 out of 5 questions to get a total knowledge score out of 100%. Only 1082/1124 participants provided sufficient information to calculate a knowledge score.|||percentage of correct answers||Standard Deviation|Mean
2556193|NCT02729753|Secondary|Device Performance: Ease of Deployment of Device|Likert Scale measuring physician satisfaction. 0 (worst) to 10 (best)|Minutes, from start to end of procedure|CryoBalloon Full and Swipe Ablation Systems used by physicians to perform ablation|||units on a scale||Full Range|Mean
2556194|NCT02729753|Secondary|Device Performance: Average Procedure Time|Average Procedure time as measured from start to finish of ablation.|Minutes from start to end of procedure||||Minutes||Full Range|Mean
2556195|NCT02729753|Primary|Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems|"Evaluated by depth and uniformity of ablation effect in the esophagus based on histopathologic assessment.~Dose response by effect of ablation to submucosa:~0: Normal~Inflammatory cell infiltration~Separation with inflammation~Edema and Necrosis"|2 weeks|Submucosal evaluation done for patients at differing doses.|||units on a scale|||Number
2556196|NCT02729753|Primary|Safety of the CryoBalloon™ Full and Swipe Ablation System|Number of participants with serious, device-related adverse events after treatment with the CryoBalloon™ Swipe Ablation System|2 weeks||||Participants|||Count of Participants
2556197|NCT02729545|Secondary|Changes in the Number of Bleeding Events From Baseline to the End of Treatment|Changes in the number of bleeding events, values after 12-week treatment minus the values at baseline|baseline and 12 weeks|Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason.|||bleeding events||95% Confidence Interval|Mean
2556198|NCT02729545|Secondary|Changes in Polycystic Ovary Number From Baseline to the End of Treatment|the changes in polycystic ovary number, values after 12-week treatment minus the values at baseline|baseline and 12 weeks|Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason.|||polycystic ovaries||Inter-Quartile Range|Mean
2556199|NCT02729545|Secondary|Changes in Ovarian Volume From Baseline to the End of Treatment|changes in ovarian volume, values after 12-week treatment minus the values at baseline|baseline and 12 weeks|Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason.|||cm^3||95% Confidence Interval|Mean
2556200|NCT02729545|Secondary|Changes in Total Testosterone (TT) From Baseline to the End of Treatment|changes in total testosterone (TT) , values after 12-week treatment minus the values at baseline|baseline and 12 weeks|Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason.|||nmol/L||95% Confidence Interval|Mean
2556201|NCT02729545|Secondary|Changes in Body Mass Index (BMI) From Baseline to the End of Treatment|the changes in BMI, values after 12-week treatment minus the values at baseline|baseline and 12 weeks|Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason.|||kg/m^2||95% Confidence Interval|Mean
2556202|NCT02729545|Secondary|Changes in FSH From Baseline to the End of Treatment|changes in follicle-stimulating hormone (FSH), values after 12-week treatment minus the values at baseline|baseline and 12 weeks|Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason.|||mIU/mL||95% Confidence Interval|Mean
2556203|NCT02729545|Secondary|Changes in LH From Baseline to the End of Treatment|changes in luteinizing hormone(LH), values after 12-week treatment minus the values at baseline|baseline and 12 weeks|Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason.|||mIU/mL||95% Confidence Interval|Mean
2556204|NCT02729545|Secondary|Change in LH/FSH Ratio From Baseline to the 24th Week|the change in LH/FSH ratio, values at the 24th week minus the values at baseline|baseline to the 24th week|During the long-term observation, three participants in the acupuncture group withdrew because of living far away from hospital, pregnancy and taking other medicine. Five participants in the CPA/EE group withdrew because of taking other medicine,pregnancy, losting contact and health reason.|||ratio||95% Confidence Interval|Mean
2556205|NCT02729545|Primary|Change in LH/FSH Ratio From Baseline to the End of Treatment|the change in LH/FSH ratio, values after 12-week treatment minus the values at baseline|baseline and 12 weeks|Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason.|||ratio||95% Confidence Interval|Mean
2556206|NCT02729194|Secondary|Number of Patients With Partial Response|Partial response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.|12 Weeks after start of study treatment|16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol.|||Participants|||Count of Participants
2556207|NCT02729194|Secondary|Number of Participants With Complete Response|Complete response is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.|12 Weeks after start of study treatment|16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol.|||Participants|||Count of Participants
2556208|NCT02729194|Secondary|Percentage of Patients That Respond to Treatment (Overall Response) With Pazopanib Administered Along With a Low Fat Diet|"To estimate the overall response proportion to pazopanib administered with a low fat meal by RECIST 1.1 criteria. Overall response is defined as the number patients that experience Partial Response (PR) or Complete Response (CR).~CR is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.~PR is defined as At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions."|12 Weeks after start of study treatment|16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol.|||percentage of participants||95% Confidence Interval|Number
2556209|NCT02729194|Primary|Median Total Dose|Median total dose given.|12 weeks|16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol.|||mg||Full Range|Median
2556210|NCT02729194|Primary|Duration of Treatment|The median duration of treatment will be reported.|12 weeks|16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol.|||weeks||Full Range|Median
2556211|NCT02729194|Primary|Number of Participants With Dose Reductions||12 weeks|16 participants were enrolled. 13 of the 16 enrolled participants completed the 12 weeks of pazopanib therapy on study protocol.|||Participants|||Count of Participants
2556212|NCT02729194|Primary|Number of Grade 3 or 4 Adverse Events|Number of grade 3 or 4 adverse events associated with pazopanib administered with a low fat meal by CTCAE version 4.0.|Through 12 weeks of treatment to 30 days post-treatment|16 participants were enrolled and treated.|||adverse events|||Number
2556230|NCT02729038|Secondary|Terminal Phase Half-life (t1/2) of Gepotidacin for Part 1|Serial blood samples were collected at specified time-points for PK analysis. t1/2 is defined as the time required by the concentration of the drug to reach half of its original value.|Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose.|PK Parameter Population|||hours||Full Range|Median
2561151|NCT02654717|Primary|Percent of Patients With Complete Clearance of Lesions|Percent of patients with complete clearance of actinic keratosis (AK) lesions at the end of treatment (8 weeks)|8 weeks||||Participants|||Count of Participants
2556213|NCT02729051|Secondary|Time to First Moderate or Severe Exacerbation|COPD exacerbations were identified based on the investigator's clinical judgment. Worsening symptoms of COPD that required treatment with oral/systemic corticosteroids and/or antibiotics were considered as moderate exacerbation. Worsening symptoms of COPD that required treatment with in-subject hospitalization was considered as severe exacerbation. Hazard ratio and 95% confidence interval (CI) is from a Cox proportional hazards model with covariates of treatment group, sex, exacerbation history (0, 1, >=2 moderate/severe exacerbations, prior year), smoking status (screening), stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), geographical region and percent predicted FEV1 at Baseline. Median and inter-quartile range (first and third quartile) have been presented.|Up to 25 weeks|ITT Population|||Days||Inter-Quartile Range|Median
2556214|NCT02729051|Secondary|TDI Focal Score at Week 24|The TDI measures changes in the participant's dyspnoea. TDI focal score was calculated as the sum of the ratings recorded for each of the 3 individual scales (Functional Impairment, Magnitude of Task, Magnitude of Effort). Each of these scales had a possible score ranging from -6 to +6. lower scores indicating more impairment. TDI focal score was calculated as the sum of the 3 individual scores and then divided by 2 (so the range of the TDI focal score is -9 to +9). The lower the score, the more deterioration in severity of dyspnea. If a score is missing for any of the three scales, then the TDI focal score was set to missing. Analysis was performed using a repeated measures model.|Week 24|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2556215|NCT02729051|Secondary|Percentage of Responders Based on Transitional Dyspnea Index (TDI) Focal Score at Week 24|The TDI measures changes in the participant's dyspnea. TDI focal score was calculated as the sum of the ratings recorded for each of the 3 individual scales (Functional Impairment, Magnitude of Task, Magnitude of Effort). Each of these scales had a possible score ranging from -6 to +6. lower scores indicating more impairment. TDI focal score was calculated as the sum of the 3 individual scores and then divided by 2 (so the range of the TDI focal score is -9 to +9). The lower the score, the more deterioration in severity of dyspnea. If a score is missing for any of the three scales, then the TDI focal score was set to missing. A participant was considered as a responder if the on-treatment TDI focal score was at least 1 unit at that visit. Non-response was defined as a TDI focal score of less than 1 unit or a missing TDI focal score with no subsequent non-missing on-treatment scores. Analysis was performed using a generalized linear mixed model with a logit link function.|Week 24|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Percentage of Participants|||Number
2556216|NCT02729051|Secondary|Change From Baseline in SGRQ Total Score at Week 24|SGRQ is a disease-specific questionnaire designed to measure impact of respiratory disease and its treatment on HRQoL of participants with COPD. It contains 14 questions with a total of 40 items grouped into domains (Symptoms, Activity and Impacts). SGRQ total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. It ranges from 0 to 100, higher score indicates poor HRQoL. Values at Week 0, pre-dose were considered as Baseline values. Change from Baseline was calculated by subtracting Baseline value from the value at indicated time point. Analysis was performed using a MMRM method including covariates of Baseline SGRQ Total score, stratum (number of long-acting bronchodilators per day during the run-in: 0/1 or 2), visit, geographical region, treatment, visit by treatment and visit by Baseline interaction.|Baseline and Week 24|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2556217|NCT02729051|Secondary|Percentage of Responders Based on the Saint (St) George Respiratory Questionnaire (SGRQ) Total Score at Week 24|SGRQ is a disease-specific questionnaire designed to measure impact of respiratory disease and its treatment on health related quality of life (HRQoL) of participants with COPD. It contains 14 questions with a total of 40 items grouped into domains (Symptoms, Activity and Impacts). SGRQ total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. It ranges from 0 to 100, higher score indicates poor HRQoL. Response was defined as an SGRQ total score of >=4 units below Baseline. Non response was defined as a SGRQ total score <4 units below Baseline or a missing SGRQ total score with no subsequent on treatment scores. ITT Population comprised of randomized participants, excluding those who were randomized in error. A participant screened or run-in failure and also randomized was considered to be randomized in error. Analysis was performed using a generalized linear mixed model with a logit link function.|Week 24|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Percentage of Participants|||Number
2556218|NCT02729051|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 24|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. It was measured using centralized spirometry. FEV1 values at Week 0, pre-dose were considered as Baseline values. Change from Baseline was calculated by subtracting Baseline value from the value at indicated time point. Modified Per Protocol (mPP) Population was used which comprised of all participants in the Intent-to-Treat (ITT) Population, who do not have a full protocol deviation considered to impact efficacy. Data following a moderate/severe COPD exacerbation or pneumonia was excluded from analysis due to the potential impact of the exacerbation or the medications used to treat it. Participants with partial protocol deviations considered to impact efficacy were included in the mPP Population but had their data excluded from analysis from the time of deviation onwards. Analysis was performed using a mixed model repeated measures (MMRM) method.|Baseline and Week 24|mPP Population|||Liter||Standard Error|Least Squares Mean
2556231|NCT02729038|Secondary|Lambda_z of Gepotidacin for Part 2|Serial blood samples were collected at specified time-points for PK analysis. It is the ratio of clearance to volume of distribution and is expressed in units of 1/hour.|Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose on during treatment period 1 and 2 both|PK Parameter Population|||Per hour||Geometric Coefficient of Variation|Geometric Mean
2556232|NCT02729038|Secondary|Terminal Elimination Rate Constant (lambda_z) of Gepotidacin for Part 1|Serial blood samples were collected at specified time-points for PK analysis. It is the ratio of clearance to volume of distribution and is expressed in units of 1/hour.|Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose.|PK Parameter Population|||Per hour||Geometric Coefficient of Variation|Geometric Mean
2561152|NCT02654652|Secondary|Infection Rate|According to Dindo et al, 2004|7 days||||Participants|||Count of Participants
2556219|NCT02729038|Secondary|Total Amount of Unchanged Amount of Drug Removed by Hemodialysis (Arem) From Time 0 to 1 Hour After the Start of Hemodialysis (Arem[0-1]), Arem (1-2), Arem (2-3), Arem (3-4) for Part 2|Arem is defined as the total amount of drug removed using the hemodialysis method at different timepoints namely Arem (0-1), measured the amount of drug removed by hemodialysis from time 0 to 1 hour after the start of hemodialysis; Arem (1-2), measured the amount of drug removed by hemodialysis from time 1 to 2 hours after the start of hemodialysis; Arem(2-3) ), measured the amount of drug removed by hemodialysis from time 2 to 3 hour, Arem (3-4), measured the amount of drug removed by hemodialysis from hemodialysis from time 3 to 4 hours after the start of hemodialysis (or to the end of dialysis if <4 hours). Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose, 0-1 hours, 1-2 hours, 2-3 hours and 3-4 hours post-dose on Day 1 in Period 1Dialysate fluid were collected at 1, 2, 3, and 4 hours post-dose in Period 1 only|PK Parameter Population|||milligram||Geometric Coefficient of Variation|Geometric Mean
2556220|NCT02729038|Secondary|Ae(t1-t2) of Gepotidacin for Part 2|Ae (t1-t2), measure the amount of drug excreted in urine in a time intervals for predose, 0 to 6, 6 to 12, 12 to 24, or 24 to 36, and 36 to 48 hours after dosing for participant's with renal impairment; and predose, 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours for participant's with normal renal function. NA indicates data is not available due to insufficient participants.Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose (0.0), 0 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during both treatment period 1 and 2|PK Parameter Population|||milligram||Geometric Coefficient of Variation|Geometric Mean
2556221|NCT02729038|Secondary|Cumulative Amount of Drug Excreted in Urine From Time t1 to t2 (Ae[t1-t2]) of Gepotidacin for Part 1, for Moderate and Severe|Ae (t1-t2), measure the amount of drug excreted in urine in a time intervals for predose, 0 to 6, 6 to 12, 12 to 24, or 24 to 36, and 36 to 48 hours after dosing for participant's with renal impairment. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|at pre-dose (0.0), 0 to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 36, and 36 to 48 hours post-dose during the single treatment period|PK Parameter Population|||milligram||Geometric Coefficient of Variation|Geometric Mean
2556222|NCT02729038|Secondary|Cumulative Amount of Drug Excreted in Urine From Time t1 to t2 (Ae[t1-t2]) of Gepotidacin for Part 1, for Normal|Ae (t1-t2), measure the amount of drug excreted in urine in a time intervals for predose, 0 to 6, 6 to 12, 12 to 24, or 24 to 36, and 36 to 48 hours after dosing for participant's with renal impairment; and predose, 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours for participant's with normal renal function.|At Pre-dose, 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours|PK Parameter Population|||milligram||Geometric Coefficient of Variation|Geometric Mean
2556223|NCT02729038|Secondary|Vz of Gepotidacin for Part 2|Serial blood samples were collected at specified time-points for PK analysis. Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vz is the apparent volume of distribution at terminal phase. Volume of distribution of the terminal phase was calculated as total administered dose of gepotidacin divided by AUC (0-inf) multiplied by the rate constant.|Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose during treatment period 1 and 2 both.|PK Parameter Population|||Liter||Geometric Coefficient of Variation|Geometric Mean
2556224|NCT02729038|Secondary|Volume of Distribution of the Terminal Phase (Vz) of Gepotidacin for Part 1|Serial blood samples were collected at specified time-points for PK analysis. Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vz is the apparent volume of distribution at terminal phase. Volume of distribution of the terminal phase was calculated as total administered dose of gepotidacin divided by AUC (0-inf) multiplied by the rate constant.|Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose.|PK Parameter Population|||Liter||Geometric Coefficient of Variation|Geometric Mean
2556225|NCT02729038|Secondary|Vss of Gepotidacin for Part 2|Serial blood samples were collected at specified time-points for PK analysis. Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose during treatment period 1 and 2 both.|PK Parameter Population|||Liter||Geometric Coefficient of Variation|Geometric Mean
2556226|NCT02729038|Secondary|Volume of Distribution at Steady State of Parent Drug (Vss) of Gepotidacin for Part 1|Serial blood samples were collected at specified time-points for PK analysis. Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose.|PK Parameter Population|||Liter||Geometric Coefficient of Variation|Geometric Mean
2556227|NCT02729038|Secondary|Tmax of Gepotidacin for Part 2|Serial blood samples were collected at specified time-points for PK analysis. Tmax was defined as the time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose during treatment period 1 and 2 both.|PK Parameter Population|||hours||Full Range|Median
2556228|NCT02729038|Secondary|Time to Maximum Plasma Concentration (Tmax) of Gepotidacin for Part1|Serial blood samples were collected at specified time-points for PK analysis. Tmax was defined as the time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose.|Pharmacokinetic Parameter Population|||hours||Full Range|Mean
2556229|NCT02729038|Secondary|t1/2 of Gepotidacin for Part 2|Serial blood samples were collected at specified time-points for PK analysis. t1/2 is defined as the time required by the concentration of the drug to reach half of its original value.|Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose during treatment period 1 and 2 both.|Pharmacokinetic Parameter Population|||hours||Full Range|Median
2556233|NCT02729038|Secondary|CL of Gepotidacin for Part 2|Serial blood samples were collected at specified time-points for PK analysis. Systemic CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma AUC(0-inf).|At pre-dose and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose in each of the two treatment periods|PK Parameter Population|||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
2556234|NCT02729038|Secondary|Systemic Clearance (CL) of Gepotidacin for Part 1|Serial blood samples were collected at specified time-points for PK analysis. Systemic CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma AUC(0-inf).|At pre-dose and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose during the single treatment period.|PK Parameter Population|||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
2556235|NCT02729038|Secondary|AUC (0-t) of Gepotidacin for Part 2|Serial blood samples were collected at specified time-points for PK analysis. The data for Area under the concentration-time curve from time 0 (predose) to time of last quantifiable concentration for gepotidacin were reported.|Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose during treatment period 1 and 2 both.|PK Parameter Population|||Nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2556236|NCT02729038|Secondary|AUC (0-t) of Gepotidacin for Part 1|Blood samples were collected at specified time-points for PK analysis. The data for Area under the concentration-time curve from time 0 (predose) to time of last quantifiable concentration for gepotidacin were reported.|Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose.|PK Parameter Population|||Nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2556237|NCT02729038|Secondary|Number of Participants With Abnormal Physical Examination Results for Part 2|Physical exam were to be performed by a qualified individual. A complete physical examination included, at a minimum, an assessment of the cardiovascular, respiratory, GI, and neurological systems. Height and weight were also measured and recorded. A brief physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). This data was not collected.|Up to 23 Days|Safety Population: This data was not collected.||||||
2556238|NCT02729038|Secondary|Number of Participants With Abnormal Physical Examination Results for Part 1|Physical exam were to be performed by a qualified individual. A complete physical examination included, at a minimum, an assessment of the cardiovascular, respiratory, GI, and neurological systems. Height and weight were also measured and recorded. A brief physical examination included, at a minimum, assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). This data was not collected.|Up to 16 Days|Safety Population. This data was not collected.||||||
2556239|NCT02729038|Secondary|Number of Participants With Clinical Laboratory Test Results for Grade 3 or Higher for Part 2|The adverse events reported by the participants were classified as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 as life-threatening. The data for clinical laboratory findings with values of Grade 3 or higher, have been reported.|Up to 24 Days|Safety Population|||Participants|||Number
2556240|NCT02729038|Secondary|Number of Participants With Clinical Laboratory Test Results for Grade 3 or Higher for Part 1|The adverse events reported by the participants were classified as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 as life-threatening. The data for clinical laboratory findings with values of Grade 3 or higher, have been reported.|Up to 17 Days|Safety Population|||Participants|||Number
2556241|NCT02729038|Secondary|Number of Participants With Any AEs and Any SAEs for Part 2|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function.|Up to 23 Days|Safety Population|||Participants|||Number
2556242|NCT02729038|Secondary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) for Part 1|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function.|Up to 16 Days|Safety Population|||Participants|||Number
2556243|NCT02729038|Secondary|Change From Baseline in Vitals- Pulse Rate, Part 2|Vital signs were measured in semi-supine position after 5 minutes of rest. The data for change from Baseline values for pulse rate was reported. Change from Baseline, was defined as post Baseline values minus the values at Baseline. Baseline was defined as the latest pre-dose assessment. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Up to 23 Days|Safety Population.|||beats per minute||Standard Deviation|Mean
2556244|NCT02729038|Secondary|Change From Baseline in Vitals- Pulse Rate, Part 1|Vital signs were measured in semi-supine position after 5 minutes of rest. The data for change from Baseline values for pulse rate was reported. Change from Baseline, was defined as post Baseline values minus the values at Baseline. Baseline was defined as the latest pre-dose assessment|Baseline and up to 16 Days|Safety Population|||Beats per minute||Standard Deviation|Mean
2556245|NCT02729038|Secondary|Change From Baseline in Vitals- SBP and DBP, Part 2|Vital signs were measured in semi-supine position after 5 minutes of rest. The data for change from Baseline values for systolic blood pressure (SBP) and diastolic blood pressure (DBP) was reported. Change from Baseline, was defined as post Baseline values minus the values at Baseline. Baseline was defined as the latest pre-dose assessment. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 23 Days|Safety Population|||Milliliter of mercury||Standard Deviation|Mean
2561911|NCT02643082|Primary|Specific Airway Resistance (siRaw)|Specific image-based airway resistance. Average across lobes, adjusted for lobe volume|Day 15|ITT Population|||kPa s||95% Confidence Interval|Geometric Least Squares Mean
2556246|NCT02729038|Secondary|Change From Baseline in Vitals- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure, Part 1|Vital signs were measured in semi-supine position after 5 minutes of rest. The data for change from Baseline values for systolic blood pressure (SBP) and diastolic blood pressure (DBP) was reported. Baseline was defined as the latest pre-dose assessment. Change from Baseline, was defined as post Baseline values minus the values at Baseline.|Baseline and up to 16 Days|Safety Population|||Milliliter of mercury||Standard Deviation|Mean
2556247|NCT02729038|Secondary|Number of Participants With Abnormal 12-lead ECG Readings for Part 2|Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and corrected Q to T interval (QTc). The data for abnormal ECG recordings not clinically significant (NCS) and clinically significant (CS), have been reported at specific time points during the study. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). NA indicates data was not available|Up to 23 Days|Participants|||Participants|||Number
2556248|NCT02729038|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Readings for Part 1|Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and corrected Q to T interval (QTc). The data for abnormal ECG recordings not clinically significant (NCS) and clinically significant (CS), have been reported at specific timepoints during the study. No formal analysis of group comparison was planned for dialysate PK parameters|Up to 16 Days|The Safety Population consisted of all participants who received at least 1 dose of study drug and had at least 1 post dose safety assessment.|||Participants|||Number
2556249|NCT02729038|Primary|Fraction (%) of the Dose Removed by Hemodialysis From 0 to 4 Hours After the Start of Hemodialysis (Frem%[0-4]) of Gepotidacin for Part 2|Dialysate samples were collected at specified time points in the study. Frem is defined as the fraction (dose in percentage) removed by the process of hemodialysis from 0 to 4 hours after the start of hemodialysis (or to the end of dialysis if less than 4 hours)|Pre-dose, 0-1 hours, 1-2 hours, 2-3 hours and 3-4 hours post-dose on Day 1 in Period 1|PK Parameter Population|||Percentage of gepotidacin removed||Geometric Coefficient of Variation|Geometric Mean
2556250|NCT02729038|Primary|Dialysis Clearance (CLD) of Gepotidacin for Part 2|CLD measured the dialysis clearance of gepotidacin over the specified duration in the study and indicates how quickly gepotidacin is cleared out from blood or plasma. Only applicable to Part 2 ESRD on hemodialysis (before hemodialysis) arm.|Pre-dose, 0-1 hours, 1-2 hours, 2-3 hours and 3-4 hours post-dose on Day 1 in Period 1||||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
2556251|NCT02729038|Primary|AUC (t0-t1) of Gepotidacin for Part 2|Partial area under the curve estimated from predialyzer samples collected from start of dialysis (t0) to end of dialysis (t1). Only applicable to Part 2 ESRD on hemodialysis (before hemodialysis) arm..|Dialysate fluid were to be collected on Day 1 after dosing (Period 1 only) at pre-dose from 0 to 4 hours|PK parameter Population.|||Nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2556252|NCT02729038|Primary|CLr of Gepotidacin for Part 2|Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time via renal clearance pathways, expressed as volume (Liter) per unit of time (hour). Urine samples were collected at pre-dose (0.0), 0 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose in each of the two treatment periods. Only those participant's available at the specified time points were analyzed. No formal statistical analysis of group comparison was planned for urine PK parameters.|At pre-dose (0.0), 0 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose in each of the two treatment periods|PK Parameter Population|||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
2556253|NCT02729038|Primary|Renal Clearance (CLr) of Gepotidacin for Part 1|Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time via renal clearance pathways, expressed as volume (Liter) per unit of time (hour). The renal clearance was calculated by Ae total divided by AUC from hour 0 to the last measurable plasma concentration AUC (0-t). Urine samples were collected at pre-dose (0.0), 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during the single treatment period. No formal statistical analysis of group comparison was planned for urine PK parameters.|At pre-dose (0.0), 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during the single treatment period|PK Parameter Population|||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
2556254|NCT02729038|Primary|fe% of Gepotidacin for Part 2|The fe% measured the percentage of the given dose of drug gepotidacin, excreted in urine. It was calculated as: Ae total divided by the dose administered multiplied by 100. No formal statistical analysis of group comparison was planned for urine PK parameters. Only those participants available at the specified time points were analyzed.|At pre-dose (0.0), 0 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose in each of the two treatment periods|PK Parameter Population|||Percentage of gepotidacin||Geometric Coefficient of Variation|Geometric Mean
2556255|NCT02729038|Primary|Percentage of the Given Dose Excreted in Urine (fe%) of Gepotidacin for Part 1|The fe% measured the percentage of the given dose of drug gepotidacin, excreted in urine. It was calculated as: Ae total divided by the dose administered multiplied by 100.|At pre-dose (0.0), 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during the single treatment period|PK Parameter Population|||Percentage of gepotidacin||Geometric Coefficient of Variation|Geometric Mean
2556256|NCT02729038|Primary|Ae Total of Gepotidacin for Part 2|Urine samples, from the participants were collected during the study. Ae total assessed the, total unchanged drug (total amount of drug excreted in urine), which was calculated, by adding all the fractions of drug gepotidacin collected, at the indicated time points. Urine samples were collected at pre-dose (0.0), 0 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during the single treatment period. Only those participant's available at the specified time points were analyzed. No formal statistical analysis of group comparison was planned for urine PK parameters.|Pre-dose (0.0), 0 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during both treatment period 1 and 2|PK Parameter Population|||milligram||Geometric Coefficient of Variation|Geometric Mean
2556257|NCT02729038|Primary|Total Amount Excreted in Urine (Ae Total), Part 1|Urine samples from the participants were collected during the study. Ae total assessed the, total unchanged drug (total amount of drug excreted in urine), which was calculated, by adding all the fractions of drug gepotidacin collected, at the indicated time points. No formal statistical analysis of group comparison was planned for urine PK parameters.|Pre-dose (0.0), 0 to 2 hours, 2 to 4 hours, 4 to 6 hours, 6 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 36 hours, and 36 to 48 hours post-dose during the single treatment period|PK Parameter Population.|||milligram.||Geometric Coefficient of Variation|Geometric Mean
2556258|NCT02729038|Primary|Cmax of Gepotidacin for Part 2|Cmax, is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected, at the indicated time points for analysis of gepotidacin.|Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose on during treatment period 1 and 2 both.|PK Parameter Population|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2556259|NCT02729038|Primary|Maximum Observed Plasma Concentration (Cmax) of Gepotidacin for Part 1|Cmax, is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected, at the indicated time points for analysis of gepotidacin.|Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose.|PK Parameter Population.|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2556260|NCT02729038|Primary|AUC (0-inf) of Gepotidacin for Part 2|AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for gepotidacin. Blood samples were collected at the indicated time-points, during the study.|Pre-dose, 0.25 hours, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose during treatment period 1 and 2 both.|PK Parameter Population.|||Nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2556261|NCT02729038|Primary|Area Under the Plasma Concentration Time Curve (AUC) From Hour 0 to Infinity (AUC[0-inf]) of Gepotidacin for Part 1|AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity . Blood samples were collected at the indicated time-points, during the study. The Pharmacokinetic (PK) Parameter Population consisted of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. The PK Population consisted of all participant's, who received at least 1 dose of gepotidacin and had evaluable PK data.|Pre-dose, 0.25 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose.|PK Parameter Population.|||Nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2556262|NCT02729025|Secondary|Percent Change From Baseline in Apolipoprotein B Concentration at Week 16||Baseline and week 16|Participants who received at least 1 dose of study drug with available data|||percent change||Standard Error|Least Squares Mean
2556263|NCT02729025|Secondary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Concentration at Week 16||Baseline and week 16|Participants who received at least 1 dose of study drug with available data|||percent change||Standard Error|Least Squares Mean
2556264|NCT02729025|Secondary|Percent Change From Baseline in Lipoprotein(a) Concentration at Week 16||Baseline and week 16|Participants who received at least 1 dose of study drug with available data|||percent change||Standard Error|Least Squares Mean
2556265|NCT02729025|Primary|Percent Change From Baseline in Maximum Target-to-background Ratio in the Most Diseased Segment of the Index Vessel at Week 16|"Arterial inflammation was assessed using 18F-fluoro-deoxyglucose positron-emission tomography/computed tomography (18F-FDG PET/CT). Arterial 18F-FDG uptake is correlated with arterial macrophage content and predicts cardiovascular events. Images were analyzed by an experienced radiologist blinded to all patient characteristics.~The maximum standardized uptake value was calculated as a time- and dose- corrected tissue radioactivity divided by body weight in the index and the target-to-background ratio (TBR) was calculated from the ratio of the standardized uptake value of the artery compared to mean background venous activity. The average maximum TBR for the most diseased segment (MDS) was calculated from a group of 3 contiguous slices (approximately 1.5 cm), centered on the slice with the highest maximum TBR in the index vessel. The index vessel was defined as the vessel (either the right or left carotid or aorta) with the highest mean TBR at baseline."|Baseline and week 16|Participants who received at least 1 dose of study drug with available data|||percent change||Standard Error|Least Squares Mean
2556266|NCT02728895|Secondary|Ctrough: Serum Concentration Before Dosing for Vedolizumab||Days 13 and 42 pre-dose|The PK population was defined as participants from the safety set with at least 1 PK sample collected. The PK population where data at specified time points was available.|||mcg/mL||Standard Deviation|Mean
2556267|NCT02728895|Secondary|Percentage of Participants With Maximum Severity of Acute GvHD Based on Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Modified International Bone Marrow Transplant Registry Database (IBMTR) Index|Maximum severity of acute GvHD was assessed by using BMT CTN modified IBMTR index. The severity index are defined as: Grade A (skin stage 1: extent of rash less than [<] 25%); Grade B (skin stage 2: extent of rash 25 to 50% or liver stage 1 to 2: total bilirubin 34 to 102 micromole per liter [mcmol/L] or intestinal tract stage 1 to 2: volume of diarrhea 550 to 1500 milliliter per day [mL/day]); Grade C (skin stage 3: extent of rash greater than (>) 50% or liver stage 3: total bilirubin 103 to 255 mcmol/L or intestinal tract stage 3: volume of diarrhea >1500 mL/day); Grade D (skin stage 4: extent of rash bullae or liver stage 4: total bilirubin >255 or intestinal tract stage 4: volume of diarrhea severe pain and ileus).|Baseline up to Day 100|The population of participants evaluable for vedolizumab safety was defined as all participants who received any amount of vedolizumab intravenously.|||percentage of participants||95% Confidence Interval|Number
2556268|NCT02728895|Secondary|Percentage of Participants With Maximum Severity of Acute GvHD Based on Modified Glucksberg Criteria|Maximum severity was assessed using GvHD grading scale based on the modified Glucksberg criteria. The grades are defined as: Grade 1 (skin stage 1 or 2 only); Grade 2 (skin stage 3 or liver stage 1 or lower or GI stage 1 or upper GI involvement); Grade 3 (skin stage 0 to 3 plus liver stage 2 to 4 or lower GI stage 2 to 3); Grade 4 (skin stage 4 or lower GI stage 4).|Baseline up to Day 100|The population of participants evaluable for vedolizumab safety was defined as all participants who received any amount of vedolizumab intravenously.|||percentage of participants||95% Confidence Interval|Number
2561912|NCT02643082|Secondary|Airway Resistance (iRaw)|iRaw represents the airway resistance, averaged across lobes, without correction for lung lobe volume|Day 15|ITT Population|||kPa s/L||95% Confidence Interval|Geometric Least Squares Mean
2556269|NCT02728895|Secondary|Percentage of Participants With Overall Grade 2 to 4 Acute Graft-Versus-Host Disease (GvHD)|GvHD grading scale was based on the modified Glucksberg criteria. The grades are defined as: Grade 1 (skin stage 1 or 2 only); Grade 2 (skin stage 3 or liver stage 1 or lower or gastrointestinal [GI] stage 1 or upper GI involvement); Grade 3 (skin stage 0 to 3 plus liver stage 2 to 4 or lower GI stage 2 to 3); Grade 4 (skin stage 4 or lower GI stage 4).|Baseline up to Day 100|The population of participants evaluable for vedolizumab safety was defined as all participants who received any amount of vedolizumab intravenously.|||percentage of participants||95% Confidence Interval|Number
2556270|NCT02728895|Secondary|Time to Neutrophil Engraftment|Time to neutrophil engraftment (recovery of ANC) was defined by an ANC >500/mm^3 for 3 consecutive days or >2000/mm^3 for 1 day. Time to neutrophil engraftment was calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval.|Baseline up to Day 100|The population of participants evaluable for vedolizumab safety was defined as all participants who received any amount of vedolizumab intravenously.|||days||95% Confidence Interval|Median
2556271|NCT02728895|Primary|Mean Serum Concentrations of Vedolizumab That Helped the Likelihood of Alpha4Beta7 Target Saturation on Day 100 Following Allo-HSCT||Day 100|The pharmacokinetic (PK) population was defined as participants from the safety set with at least 1 PK sample collected. The PK population where data at specified time points was available.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2556272|NCT02728895|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||Up to 18 weeks after last dose of study drug|The population of participants evaluable for vedolizumab safety was defined as all participants who received any amount of vedolizumab intravenously.|||Participants|||Count of Participants
2556273|NCT02728895|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|DLTs was based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and was defined as any of following events: Grade 3 or higher toxicity assessed by the investigator as related to vedolizumab treatment; Grade 4 or higher regimen-related organ toxicities; and failure to engraft by Day +28. Engraftment was defined as absolute neutrophils count (ANC) greater than (>) 500 per cubic millimeter (/mm^3) for 3 consecutive days or >2000/mm^3 for 1 day.|Baseline up to Day 28|The population of participants evaluable for vedolizumab safety was defined as all participants who received any amount of vedolizumab intravenously.|||Participants|||Count of Participants
2556274|NCT02728258|Other Pre-specified|Mutation Subtypes and Clinical Outcomes|Associations between mutation subtypes and clinical outcomes will be explored using standard statistical methods for categorical and time to event data.|Up to 5 years|||||||
2556275|NCT02728258|Secondary|The Frequency and Severity of CTCAE v4 Graded Adverse Events|Maximum grade of physician assessed adverse events reported during treatment|Study Start: September 16, 2016, Primary Completion: June 30, 2018, approximate study duration 1 year 9 months|Eligible and treated patients|||participants|||Number
2556276|NCT02728258|Secondary|Median Overall Survival|Median time of overall survival|September 16,2016 to April 4,2019, approximate duration of 2 years, 7 months|Eligible and treated patients|||Months||95% Confidence Interval|Median
2556277|NCT02728258|Secondary|Median Progression-Free Survival Using RECIST 1.1 Criteria|The median progression-free survival time|September 16,2016 to April 4,2019, approximate duration of 2 years, 7 months|Eligible and treated patients|||Months||95% Confidence Interval|Median
2556278|NCT02728258|Secondary|Percentage of Participants Alive and Progression-free at 6 Months|Percentage of participants who are progression free at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 6 months from enrollment|Eligible and treated patients|||percentage of participants|||Number
2556279|NCT02728258|Primary|Frequency of Objective Response Defined by RECIST 1.1 Criteria|Confirmed complete and partial tumor response by RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|approximate study duration 1 year 9 months|Eligible and treated patients|||percentage of participants||95% Confidence Interval|Number
2556280|NCT02728206|Secondary|Percentage of Participants With Overall Virologic Failure|Virologic failure was defined as 1) End of Treatment Virologic Failure: HCV RNA ≥ 15 IU/mL at last observed HCV RNA measurement on or prior to last dose date of SOF/VEL + 3 days after completion of 28 ± 3 days of SOF/VEL treatment, or 2) Relapse: HCV RNA ≥ 15 IU/mL during the posttreatment follow-up period having achieved HCV RNA < 15 IU/mL at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.|Up to Posttreatment Week 12|Full Analysis Set|||Percentage of participants|||Number
2556281|NCT02728206|Secondary|Percentage of Participants With HCV RNA < LLOQ On Treatment||Days 3, 5, 7, 14, 21, and 28|Participants in the Full Analysis Set with available data were analyzed.|||Percentage of participants||95% Confidence Interval|Number
2556282|NCT02728206|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||Percentage of participants||95% Confidence Interval|Number
2556283|NCT02728206|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to Week 4|Safety Analysis Set|||Percentage of participants|||Number
2556284|NCT02728206|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set included all enrolled participants who received a liver transplant, and took at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2556300|NCT02727894|Secondary|Colorectal Cancer Resection Margins|"Difference between colorectal cancer resection margins (RX, R0, R1, R2) in screening vs. non-screening group.~RX: cannot be identified~R0: no cancer cells seen microscopically at the resection margin~R1: cancer cells present microscopically at the resection margin (microscopic positive margin)~R2: gross examination by the naked eye shows tumor tissue present at the resection margin (macroscopic positive margin)"|after surgery was performed||||Participants|||Count of Participants
2556285|NCT02728089|Secondary|Percentage of Participants With Microbiological Response of Eradication by Pathogen at LFU|"The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline. Microbiological outcome was classified as Eradication, Persistence or Indeterminate. A successful microbiological response was Eradication which was defined as urine culture showed the specific pathogen found at baseline at ≥10^5 colony-forming unit (CFU)/mL was reduced to <10^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced the result was classified as a failure. Outcomes reported as indeterminate were excluded. The percentage of participants that achieved eradication for each uropathogen LFU (42 days post first dose of study drug) was summarized.~."|Day 42 (42 days post first dose of study drug)|All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest.|||Percentage of participants||95% Confidence Interval|Number
2556286|NCT02728089|Secondary|Percentage of Participants With Microbiological Response of Eradication by Pathogen at TOC|"The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline. Microbiological outcome was classified as Eradication, Persistence or Indeterminate. A successful microbiological response was Eradication which was defined as urine culture showed the specific pathogen found at baseline at ≥10^5 colony-forming unit (CFU)/mL was reduced to <10^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced), the result was classified as a failure. Outcomes reported as indeterminate were excluded. The percentage of participants that achieved eradication for each uropathogen at TOC (14 days post first dose of study drug) was summarized."|Day 14 (14 days post first dose of study drug)|All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest.|||Percentage of participants||95% Confidence Interval|Number
2556287|NCT02728089|Secondary|Percentage of Participants With Microbiological Response of Eradication, by Pathogen at EOT|"The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline. Microbiological outcome was classified as Eradication, Persistence or Indeterminate. A successful microbiological response was Eradication which was defined as urine culture showed the specific pathogen found at baseline at ≥10^5 colony-forming unit (CFU)/mL was reduced to <10^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced the result was classified as a failure. Outcomes reported as indeterminate were excluded. The percentage of participants that achieved eradication for each uropathogen at EOT (7 days post first dose of study drug) was summarized."|Day 7 (7 days post first dose of study drug)|All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest.|||Percentage of participants||95% Confidence Interval|Number
2556288|NCT02728089|Secondary|Percentage of Participants With a Composite Response of Both Eradication and Clinical Cure at TOC|The percentage of participants that met requirements for both eradication and clinical cure at TOC was summarized.|Day 14 (14 days post first dose of study drug)|All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest.|||Percentage of participants||95% Confidence Interval|Number
2556289|NCT02728089|Secondary|Percentage of Participants With Clinical Response of Clinical Cure at LFU|"The Investigator classified clinical outcome as clinical cure, clinical failure, or indeterminate. A favorable clinical response is clinical cure defined as complete resolution of, marked improvement in (where clinical improvement was defined as a reduction in severity of all baseline signs and symptoms with worsening of none and with no requirement for additional antibiotic therapy after EOT), or return to pre-infection signs and symptoms and no use of additional or nonstudy antimicrobial therapy for the treatment of the current UTI. Outcomes reported as indeterminate were excluded. Percentage of participants with clinical response of clinical cure at LFU was summarized."|Day 42 (42 days post first dose of study drug)|All participants who received at least 1 dose of study treatment, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures and had a clinical response at the visit of interest within the specified visit window. All participants had to have an evaluable clinical outcome; an indeterminate response was excluded.|||Percentage of participants||95% Confidence Interval|Number
2556290|NCT02728089|Secondary|Percentage of Participants With Clinical Response of Clinical Cure at EOT|"The Investigator classified clinical outcome as clinical cure, clinical failure, or indeterminate. A favorable clinical response is clinical cure defined as complete resolution of, marked improvement in (where clinical improvement was defined as a reduction in severity of all baseline signs and symptoms with worsening of none and with no requirement for additional antibiotic therapy after EOT), or return to pre-infection signs and symptoms and no use of additional or nonstudy antimicrobial therapy for the treatment of the current UTI. Outcomes reported as indeterminate were excluded. Percentage of participants with clinical response of clinical cure at EOT was summarized"|Day 7 (7 days post first dose of study drug)|All participants who received at least 1 dose of study treatment, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures and had a clinical response at the visit of interest within the specified visit window. All participants had to have an evaluable clinical outcome; an indeterminate response was excluded.|||Percentage of participants||95% Confidence Interval|Number
2556301|NCT02727894|Secondary|Colorectal Cancer Grade|"Differences between colorectal cancer grade in screening vs. non-screening group.~GX (cannot be identified)~G1 (well diff.)~G2 (moderately diff.)~G3 (poorly diff.)~G4 (undifferentiated)~Grades 1,2 were considered to have connection with lower stage"|after surgery was performed||||Participants|||Count of Participants
2556302|NCT02727894|Primary|Colorectal Cancer Stage (pTNM)|"Differences between colorectal cancer stage (0,I,II) in screening vs. non-screening group.~0. stage (Tis N0 M0)~I. stage (T1-2 N0 M0)~II. stage (T3-4 N0 M0)~III. stage (T1-4 N1-2 M0)~IV. stage (T1-4 N1-2 M1)~Stages 0,I II were considered to have better outcome"|at time of diagnosis||||Participants|||Count of Participants
2556291|NCT02728089|Secondary|Percentage of Participants With Clinical Response of Clinical Cure at TOC|"The Investigator classified clinical outcome as clinical cure, clinical failure, or indeterminate. A favorable clinical response is clinical cure defined as complete resolution of, marked improvement in (where clinical improvement was defined as a reduction in severity of all baseline signs and symptoms with worsening of none and with no requirement for additional antibiotic therapy after EOT), or return to pre-infection signs and symptoms and no use of additional or nonstudy antimicrobial therapy for the treatment of the current UTI. Outcomes reported as indeterminate were excluded. Percentage of participants with clinical response of clinical cure at TOC was summarized"|Day 14 (14 days post first dose of study drug)|All participants who received at least 1 dose of study treatment, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures and had a clinical response at the visit of interest within the specified visit window. All participants had to have an evaluable clinical outcome; an indeterminate response was excluded.|||Percentage of participants||95% Confidence Interval|Number
2556292|NCT02728089|Secondary|Percentage of Participants With Microbiological Response of Eradication at Late Follow-up (LFU)|"The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline at LFU (42 days post first dose of study drug). Microbiological outcome was classified as eradication, persistence or indeterminate. A successful microbiological response was eradication which was defined as urine culture showed all uropathogens found at baseline at ≥10^5 colony-forming unit (CFU)/mL were reduced to <10^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced the result was classified as unsuccessful. Participants with responses reported as indeterminate were excluded."|Day 42 (42 days post first dose of study drug)|All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest.|||Percentage of participants||95% Confidence Interval|Number
2556293|NCT02728089|Secondary|Percentage of Participants With Microbiological Response of Eradication at End Of Therapy (EOT)|"The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline at EOT (7 days post first dose of study drug). Microbiological outcome was classified as eradication, persistence or indeterminate. A successful microbiological response was eradication which was defined as urine culture showed all uropathogens found at baseline at ≥10^5 colony-forming unit (CFU)/mL were reduced to <10^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced the result was classified as unsuccessful. Participants with responses reported as indeterminate were excluded."|Day 7 (7 days post first dose of study drug)|All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest.|||Percentage of participants||95% Confidence Interval|Number
2556294|NCT02728089|Primary|Percentage of Participants Discontinuing Study Drug Due to an AE|An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not considered related to the medicinal product. The percentage of participants that had study drug discontinued during the study due to an AE was summarized.|Up to 7 days after the first dose of study drug|All participants who received at least 1 dose of study treatment and had follow-up data for endpoint.|||Percentage of participants||95% Confidence Interval|Number
2556295|NCT02728089|Primary|Percentage of Participants Who Report 1 or More Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized.|Up to 42 days post first dose of study drug|All participants who received at least 1 dose of study treatment and had follow-up data for endpoint.|||Percentage of participants||95% Confidence Interval|Number
2556296|NCT02728089|Primary|Percentage of Participants With Microbiological Response of Eradication at Test of Cure (TOC)|"The per-pathogen microbiological outcome was determined for each uropathogen isolated at baseline at TOC (14 days post first dose). Microbiological outcome was classified as eradication, persistence or indeterminate. A successful microbiological response was eradication which was defined as urine culture showed all uropathogens found at baseline at ≥10^5 colony-forming unit (CFU)/mL were reduced to <10^4 CFU/mL. If the outcome for any uropathogen was persistence (CFU/mL not reduced the result was classified as unsuccessful. Participants with responses reported as indeterminate were excluded."|Day 14 (14 days post first dose of study drug)|All participants who received at least 1 dose of study drug, had at least 1 acceptable causative uropathogen at baseline, adhered to study procedures, had a clinical response at the visit of interest within specified visit window, had an appropriately collected urine culture specimen and interpretable urine culture result at the visit of interest.|||Percentage of participants||95% Confidence Interval|Number
2556297|NCT02727894|Secondary|Colorectal Cancer and Palliative Therapy|"Differences between neoadjuvant, adjuvant and systemic palliative therapy in screening vs. non-screening group.~Number of patients treated with palliative therapy in both groups."|during treatment plan setting||||Participants|||Count of Participants
2556298|NCT02727894|Secondary|Colorectal Cancer Surgery|Median time between diagnosis and surgery.|time between diagnosis and surgery, measured after surgery was performed||||Number of day betw. diagnosis and surg.||95% Confidence Interval|Median
2556299|NCT02727894|Secondary|Colorectal Cancer Metastasis|"Differences between occurrence of colorectal cancer metastasis (MX, M0, M1) between screening vs. non-screening group.~MX: cannot be measured~M0: cancer has not spread to other parts of the body~M1: cancer has spread to other parts of the body"|at time of diagnosis||||Participants|||Count of Participants
2556552|NCT02722837|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2556303|NCT02727842|Primary|Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire|"To evaluate usability of the CP950 sound processor using the CP950 Take Home Questionnaire for existing cochlear implant users.~Specifically:~Patient Reported Hearing Performance~Retention & Comfort~Ease of use~Use of remote controls~Look & feel~Reliability~Maintenance & use"|1 month|All enrolled subjects|||Participants|||Count of Participants
2556304|NCT02727816|Primary|Overall Fit Acceptance - Pair Four|Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. Three choices: methafilcon A (BC 8.7), somofilcon A, or no preference.|Baseline and 1 hour||||number of subjects|||Number
2556305|NCT02727816|Primary|Overall Fit Acceptance - Pair Three|Investigator's lens fit acceptance / acceptability for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. Three choices: methafilcon A (BC 8.6), ocufilcon D, or no preference.|Baseline and 1 hour||||number of subjects|||Number
2556306|NCT02727816|Primary|Overall Fit Acceptance - Pair Two|Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. Three choices: filcon IV I (BC 8.7), ocufilcon D, or no preference.|Baseline and 1 hour||||number of subjects|||Number
2556307|NCT02727816|Primary|Overall Fit Preference - Pair One|Investigator's lens fit acceptance / acceptability for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. Three choices: filcon IV I (BC 8.6), ocufilcon D, or no preference.|Baseline and 1 hour||||number of subjects|||Number
2556308|NCT02727816|Primary|Lens Tightness - Pair Four|Lens tightness on push on test for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)|Baseline and 1 hour||||percent lens tightness||Standard Deviation|Mean
2556309|NCT02727816|Primary|Lens Tightness - Pair Three|Lens tightness on push on test for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)|Baseline and 1 hour||||percent lens tightness||Standard Deviation|Mean
2556310|NCT02727816|Primary|Lens Tightness - Pair Two|Lens tightness on push on test for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)|Baseline and 1 hour||||percent lens tightness||Standard Deviation|Mean
2556311|NCT02727816|Primary|Lens Tightness - Pair One|Lens tightness on push on test for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0% - 100%, 100%=No movement, 50%=Optimum 0%=Falls from cornea without lid support)|Baseline and 1 hour||||Percent lens tightness||Standard Deviation|Mean
2556312|NCT02727816|Primary|Post-blink Movement - Pair Four|Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).|1 hour||||number of eyes|||Number
2556313|NCT02727816|Primary|Post-blink Movement - Pair Four|Post-blink movement for methafilcon A (BC 8.7) / somofilcon A (pair four) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).|Baseline||||number of eyes|||Number
2556314|NCT02727816|Primary|Post-blink Movement - Pair Three|Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).|1 hour||||number of eyes|||Number
2556315|NCT02727816|Primary|Post-blink Movement - Pair Three|Post-blink movement for methafilcon A (BC 8.6) / ocufilcon D (pair three) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).|Baseline||||number of eyes|||Number
2556316|NCT02727816|Primary|Post-blink Movement - Pair Two|Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).|1 hour||||number of eyes|||Number
2556317|NCT02727816|Primary|Post-blink Movement - Pair Two|Post-blink movement for filcon IV I (BC 8.7) / ocufilcon D (pair two) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).|Baseline||||number of eyes|||Number
2556318|NCT02727816|Primary|Post-blink Movement - Pair One|Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).|1 hour||||number of eyes|||Number
2556319|NCT02727816|Primary|Post-blink Movement - Pair One|Post-blink movement for filcon IV I (BC 8.6) / ocufilcon D (pair one) is assessed. (0-5 Likert scale, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement).|Baseline||||number of eyes|||Number
2556320|NCT02727816|Primary|Centration - Pair Four|Centration for methafilcon A (Base Curve (BC) 8.7) / somofilcon A (pair four) is assessed. (optimum, decentration acceptable, decentration unacceptable).|Baseline and 1 hour||||number of eyes|||Number
2556321|NCT02727816|Primary|Centration - Pair Three|Centration for methafilcon A (Base Curve (BC) 8.6) / ocufilcon D (pair three) is assessed. (optimum, decentration acceptable, decentration unacceptable).|Baseline and 1 hour||||number of eyes|||Number
2556322|NCT02727816|Primary|Centration - Pair Two|Centration for filcon IV I (Base Curve (BC) 8.7) / ocufilcon D (pair two) is assessed. (optimum, decentration acceptable, decentration unacceptable).|Baseline and 1 hour||||number of eyes|||Number
2556323|NCT02727816|Primary|Centration - Pair One|Centration for filcon IV I (Base Curve (BC) 8.6) / ocufilcon D (pair one) is assessed. (optimum, decentration acceptable, decentration unacceptable).|Baseline and 1 hour||||number of eyes|||Number
2556324|NCT02727777|Other Pre-specified|Exploratory Objective to Define Change of mTOR Pathway Protein Phosphorylation and the Incidence of Activating Mutations in MTOR and Related Genes.|Assessed with reverse phase protein arrays after exposure to TAK228,|Baseline to end of treatment or progression of disease|Exploratory objective was not analyzed because patients came off study before it could be analyzed, no data were collected.||||||
2556363|NCT02726620|Secondary|Average Use of Cardiovascular Drugs: Ephedrine|Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosages would be meaningless.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). In addition, only patients that actually received any ephedrine are analyzed.|||mg||Inter-Quartile Range|Median
2556325|NCT02727777|Secondary|Number of Participants With Adverse Events|Progression free survival, duration of response and overall survival analysis could not be properly evaluated due to patients being taken off study early due to progression of disease but safety and tolerability were reported through safety event reports, please see AEs-serious and non-serious section for this.|Baseline to end of treatment or progression of disease|Adverse events were evaluated for the time patients were on study however due to early progression of disease, patients did not finish the treatment and adverse events reported were not conclusive of toxicity related to drug. Updated to two participants for the secondary outcome.|||Participants|||Count of Participants
2556326|NCT02727777|Primary|Response Assessment (RA)|RA was defined by Lugano Criteria & based on CT scans obtained at screening & after completion of every 2 cycles of therapy. Complete Radiographic Response Target Nodes must regress to <=1.5cm in longest dimension,No extralymphatic sites of disease. PR >=50% decrease in sum of the product of diameters of up to 6 target measurable nodes and extranodal sites. When a lesion is too small to measure on CT, 5 mmx5mm is assigned. When not visible on CT, assign 0x0 mm. For a node 5mmx5mm use actual measurement. SD< 50% decrease in sum of the product of diameters of up to 6 target measurable nodes & extranodal sites, no criteria for disease progression are met. Progressive disease requires one of the following:An individual node must be abnormal with: LDi 1.5cm & Increase by 50% from PPD nadir & an increase in LDi or SDi from nadir 0.5cm for lesions 2cm,1cm for lesions 2cm. In case of splenomegaly, the splenic length must increase by >=50% of the extent of its prior increase beyond baseline.|Time frame for response assessment was from Baseline to end of treatment or progression of disease up to 1 year.|No analysis could be performed due to 2 participants failed screening and 2 participants disease progressed before analysis could be performed||||||
2556327|NCT02727751|Primary|Incidence of Treatment - Emergent Adverse Events >2%|Safety assessments will be based on adverse events, clinical laboratory tests, vital signs, ECG, and physical exams|52-55 weeks||||participants|||Number
2556328|NCT02727660|Secondary|Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in Saint George's Respiratory Questionnaire (SGRQ) Total Score|The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI on health-related quality of life as compared to FF MDI in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. A decrease from baseline in SGRQ total score of 4 units or more is considered a clinically meaningful improvement in quality of life.|at Week 12|mITT Population|||Percentage of Subjects|||Number
2556329|NCT02727660|Secondary|Change From Baseline in Average Daily Rescue Ventolin HFA Use|Change from baseline in average daily rescue Ventolin HFA use over 12 weeks|over 12 weeks|mITT Population Only subjects who had rescue Ventolin HFA doses recorded over the 12 week period are included in the “over 12 Weeks” timepoint|||Puffs per day||95% Confidence Interval|Least Squares Mean
2556330|NCT02727660|Secondary|Time to First Moderate or Severe COPD Exacerbation|Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation over 52 weeks|over 52 weeks|mITT Population|||Percentage of Subjects with Exacerbation||95% Confidence Interval|Number
2556331|NCT02727660|Primary|Morning Pre-dose Trough FEV1|Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12|at Week 12|mITT Population Only subjects who had morning pre-dose trough FEV1 measured at the week 12 visit are included in the “at Week 12” timepoint|||Liter||95% Confidence Interval|Least Squares Mean
2556332|NCT02727322|Secondary|Frequency of Urine Cultures Positive for Nitrofurantoin-resistant Isolates|Frequency of urine cultures with one or more organisms resistant to nitrofurantoin. Positive culture was defined as at least 100,000 colony forming units (cfu)/ml of uropathic bacteria in a catheterized or midstream clean catch voided urine specimen.|within 6 weeks of surgery||||nitrofurantoin resistant urine cultures|Positive urine cultures||Number
2556333|NCT02727322|Secondary|Number of Participants Who Experienced at Least One Adverse Event Symptom While Requiring Catheterization|This is the number of participants who experienced at least one adverse symptom as reported on the diary completed daily while requiring catheterization. These adverse symptoms included: constipation, nausea/vomiting, drowsiness, headache, flatulence, abdominal pain, dizziness, diarrhea, rash/itching, dyspepsia, fever/chills, amblyopia and other.|within 6 weeks of surgery||||Participants|||Count of Participants
2556334|NCT02727322|Primary|Number of Participants Experiencing Urinary Tract Infection Within 6 Weeks of Surgery|"Frequency of symptomatic, culture-proven UTI; included participants who were empirically treated outside of protocol (symptoms but no culture) within 6 weeks of surgery.~Positive culture was defined as at least 100,000 colony forming units (cfu)/ml of uropathic bacteria in a catheterized or midstream clean catch voided urine specimen."|within 6 weeks of surgery||||Participants|||Count of Participants
2556335|NCT02726971|Secondary|Participants With Improvement of Menstrual Pattern at Third-look Hysteroscopy|The menstrual pattern is clarified as four types which includes amenorrhea, scant spotting, light period, normal period. The menstrual pattern of every participant was recored and compared with herself (before and 3 months after surgery). The number showed below is patients whose menstrual pattern had improved after surgery and estrogen therapy.|3 months after surgery||||participants|||Number
2556336|NCT02726971|Secondary|the AFS Score at Third-look Hysteroscopy|The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.|2 months after surgery||||units on a scale||Standard Deviation|Mean
2556337|NCT02726971|Primary|the AFS Score at Second-look Hysteroscopy|The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.|1 months after the surgery||||units on a scale||Standard Deviation|Median
2556415|NCT02725866|Secondary|Percentage of Participants With Relapse|Relapse was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL.|Up to 24 weeks|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants|||Number
2556338|NCT02726945|Secondary|Efficacy - Percent Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score From Baseline to 6 Months|"The primary efficacy will be achieved if either dose group is shown to be superior to the placebo group at 6 months post-treatment, using the percent change in WOMAC score from baseline as the primary variable.~The WOMAC score consists of 3 subscales, pain, stiffness and function. The overall score is normalized to a range of 0 to 100 points with a lower score indicating less symptoms of osteoarthritis."|baseline and 6 months|The data set was analyzed with an Intent-to-treat principle and used the last observation carried forward (LOCF) method for missing data.|||percentage of change in WOMAC score||Inter-Quartile Range|Median
2556339|NCT02726945|Primary|Safety - Number of Participants With Treatment-Emergent Serious Adverse Events|Subjects will be monitored for serious and device related adverse events. Baseline MRIs will be compared to 1 year for any abnormal findings.|up to 1 year|Thirty-eight subjects were monitored to 1 year. One subject was monitored for 6 weeks, when the subject withdrew from the study to receive a total knee replacement.|||Participants|||Count of Participants
2556340|NCT02726789|Secondary|Number of Patients Experiencing Serum Anti-HBs > 10 mIU / ml|To assess antiviral activity of REP 2139-Ca when combined with pegylated interferon on anti-HBsAg antibody titer.|48 weeks (treatment)||||Participants|||Count of Participants
2556341|NCT02726789|Secondary|Number of Patients Experiencing Reductions in Serum HBV DNA|To assess antiviral activity of REP 2139-Ca when combined with pegylated interferon on serum HBV DNA.|48 weeks (treatment)||||Participants|||Count of Participants
2556342|NCT02726789|Secondary|Number of Patients Experiencing Reductions in Serum HBsAg|To assess antiviral activity of REP 2139-Ca when combined with pegylated interferon on serum HBsAg.|48 weeks (treatment)||||Participants|||Count of Participants
2556343|NCT02726789|Primary|Number of Patients Experiencing Treatment Emergent Laboratory Test Abnormalities or Adverse Events.|To record side effects, symptoms and adverse effects of exposure to REP 2139-Ca when combined pegylated interferon.|48 weeks (treatment)||||Participants|||Count of Participants
2556344|NCT02726620|Secondary|Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg|Average concentrations of inhalational anesthesia during MAP < 50 mmHg episodes|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|All patients with any MAP < 50 mmHg and a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed.|||EndTidal% (other)||Inter-Quartile Range|Median
2556345|NCT02726620|Secondary|Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg|Average concentrations of inhalational anesthesia during MAP < 55 mmHg episodes|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|All patients with any MAP < 55 mmHg and either a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed.|||EndTidal% (other)||Inter-Quartile Range|Median
2556346|NCT02726620|Secondary|Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg|Average concentrations of inhalational anesthesia during MAP < 60 mmHg episodes|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|All patients with any MAP < 60 mmHg and either a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed.|||EndTidal% (other)||Inter-Quartile Range|Median
2556347|NCT02726620|Secondary|Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg|Average concentrations of inhalational anesthesia during MAP < 65 mmHg episodes|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|All patients with any MAP < 65 mmHg and a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed.|||EndTidal% (other)||Inter-Quartile Range|Median
2556348|NCT02726620|Post-Hoc|Usage Frequency of Cardiovascular Drugs: Norepinephrine|Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||Participants|||Count of Participants
2556349|NCT02726620|Post-Hoc|Usage Frequency of Cardiovascular Drugs: Ephinephrine|Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||Participants|||Count of Participants
2556350|NCT02726620|Post-Hoc|Usage Frequency of Cardiovascular Drugs: Glycopyrrolate|Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||Participants|||Count of Participants
2556351|NCT02726620|Post-Hoc|Usage Frequency of Cardiovascular Drugs: Phenylephrine|Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||Participants|||Count of Participants
2556352|NCT02726620|Post-Hoc|Usage Frequency of Cardiovascular Drugs: Ephedrine|Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in <1% of cases are not reported.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||Participants|||Count of Participants
2556353|NCT02726620|Post-Hoc|Postoperative Acute Kidney Injury|Postoperative Acute Kidney Injury (AKI), Stage I or higher according to the KDIGO criteria (Kidney Disease: Improving Global Outcomes). The staging will be based on serum creatinine values, as documentation of urine output is probably not sufficiently accurate. This will be the primary outcome for the Vanderbilt University Medical Center. The creatinine measurements are part of routine clinical care. Therefore, absence of creatinine postoperative measurements are considered to be 'no suspicion of kidney injury'. KDIGO defines AKI as any of the following: Increase in serum creatinine by 0.3mg/dL or more within 48 hours or Increase in serum creatinine to 1.5 times baseline or more within the last 7 days or Urine output less than 0.5 mL/kg/h for 6 hours. Stage 1 is 1.5-9x baseline or >0.3 increase; Stage 2 is 2-2.9x baseline; Stage 3 is 3x baseline, or increase to > 4, or initiation of renal replacement therapy.|Within 7 days after surgery|Post-Hoc analysis: all patients, not only those with any MAP < 65 mmHg.|||Participants|||Count of Participants
2556354|NCT02726620|Secondary|Intraoperative Administration of Intravenous Fluids|Total amount (mL) of intravenous fluids (as defined under interventions) administered during the surgical procedure.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||mL||Inter-Quartile Range|Median
2556355|NCT02726620|Secondary|Timing of Cardiovascular Drugs for MAP < 50 mmHg|Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 50 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|All patients with any MAP < 50 mmHg and an administration event of a cardiovascular drugs within 5 minutes before the start of the hypotensive episode (the first value below 50 mmHg) and 15 minutes after the start of the episode.|||minutes||Inter-Quartile Range|Median
2556356|NCT02726620|Secondary|Timing of Cardiovascular Drugs for MAP < 55 mmHg|Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 55 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|All patients with any MAP < 55 mmHg and an administration event of a cardiovascular drugs within 5 minutes before the start of the hypotensive episode (the first value below 55 mmHg) and 15 minutes after the start of the episode.|||minutes||Inter-Quartile Range|Median
2556357|NCT02726620|Secondary|Timing of Cardiovascular Drugs for MAP < 60 mmHg|Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 60 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|All patients with any MAP < 60 mmHg and an administration event of a cardiovascular drugs within 5 minutes before the start of the hypotensive episode (the first value below 60 mmHg) and 15 minutes after the start of the episode.|||minutes||Inter-Quartile Range|Median
2556358|NCT02726620|Secondary|Timing of Cardiovascular Drugs for MAP < 65 mmHg|Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 60 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|All patients with any MAP < 65 mmHg and an administration event of a cardiovascular drugs within 5 minutes before the start of the hypotensive episode (the first value below 65 mmHg) and 15 minutes after the start of the episode.|||minutes||Inter-Quartile Range|Median
2556359|NCT02726620|Secondary|Average Use of Cardiovascular Drugs: Norepinephrine|Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). In addition, only patients that actually received any norepinephrine are analyzed.|||mg||Inter-Quartile Range|Median
2556360|NCT02726620|Secondary|Average Use of Cardiovascular Drugs: Epinephrine|Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). In addition, only patients that actually received any epinephrine are analyzed.|||mg||Inter-Quartile Range|Median
2556361|NCT02726620|Secondary|Average Use of Cardiovascular Drugs: Glycopyrrolate|Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). In addition, only patients that actually received any glycopyrrolate are analyzed.|||mg||Inter-Quartile Range|Median
2556362|NCT02726620|Secondary|Average Use of Cardiovascular Drugs: Phenylephrine|Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). In addition, only patients that actually received any phenylephrine are analyzed.|||mg||Inter-Quartile Range|Median
2556364|NCT02726620|Secondary|Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg|Average concentrations of propofol infusion rates during MAP < 50 mmHg episodes|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|All patients with any MAP < 50 mmHg and a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed.|||mcg/kg/min (propofol)||Inter-Quartile Range|Median
2556365|NCT02726620|Secondary|Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg|Average concentrations of propofol infusion rates during MAP < 55 mmHg episodes|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|All patients with any MAP < 55 mmHg and either a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed.|||mcg/kg/min (propofol)||Inter-Quartile Range|Median
2556366|NCT02726620|Secondary|Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg|Average concentrations of propofol infusion rates during MAP < 60 mmHg episodes|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|All patients with any MAP < 60 mmHg and either a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed.|||mcg/kg/min (propofol)||Inter-Quartile Range|Median
2556367|NCT02726620|Secondary|Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg|Average concentrations of propofol infusion rates during MAP < 65 mmHg episodes|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|All patients with any MAP < 65 mmHg and a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed.|||mcg/kg/min (propofol)||Inter-Quartile Range|Median
2556368|NCT02726620|Secondary|Time to Discharge Readiness at the Postanesthesia Care Unit (PACU)|The time from arriving at the postanesthesia care unit (PACU) until the time the patient is considered ready for discharge (in minutes).|A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU, an expected average of 4 hours|Only patients with a postoperative stay at the postanesthesia care unit (PACU). Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||minutes||Inter-Quartile Range|Median
2556369|NCT02726620|Secondary|Estimated Intraoperative Blood Loss|The estimated blood loss in mL during the surgical procedure|During the surgical procedure: an expected average of 2 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||mL||Inter-Quartile Range|Median
2556370|NCT02726620|Secondary|Depth and Duration of Intraoperative Hypotension - Threshold MAP 50 mmHg|Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||mmHg*minute||Inter-Quartile Range|Median
2556371|NCT02726620|Secondary|Depth and Duration of Intraoperative Hypotension - Threshold MAP 55 mmHg|Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||mmHg*minute||Inter-Quartile Range|Median
2556372|NCT02726620|Secondary|Depth and Duration of Intraoperative Hypotension - Threshold MAP 60 mmHg|Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||mmHg*minute||Inter-Quartile Range|Median
2556373|NCT02726620|Secondary|Depth and Duration of Intraoperative Hypotension - Threshold MAP 65 mmHg|Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||mmHg*minute||Inter-Quartile Range|Median
2556416|NCT02725866|Secondary|Percentage of Participants With Virologic Response at End of Treatment (EoT)|Virologic response was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment.|Up to 24 weeks|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants||95% Confidence Interval|Number
2556374|NCT02726620|Secondary|Depth and Duration of Intraoperative Hypotension - Threshold MAP 70 mmHg|Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||mmHg*minute||Inter-Quartile Range|Median
2556375|NCT02726620|Secondary|Depth and Duration of Intraoperative Hypotension - Threshold MAP 75 mmHg|Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||mmHg*minute||Inter-Quartile Range|Median
2556376|NCT02726620|Secondary|Incidence of a MAP < 50 mmHg for > 20 Minutes|Incidence of a mean arterial pressure (MAP) < 50 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||Participants|||Count of Participants
2556377|NCT02726620|Secondary|Incidence of a MAP < 55 mmHg for > 20 Minutes|Incidence of a mean arterial pressure (MAP) < 55 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||Participants|||Count of Participants
2556378|NCT02726620|Secondary|Incidence of a MAP < 60 mmHg for > 20 Minutes|Incidence of a mean arterial pressure (MAP) < 60 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||Participants|||Count of Participants
2556379|NCT02726620|Secondary|Incidence of a MAP < 50 mmHg for > 10 Minutes|Incidence of a mean arterial pressure (MAP) < 50 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||Participants|||Count of Participants
2556380|NCT02726620|Secondary|Incidence of a MAP < 55 mmHg for > 10 Minutes|Incidence of a mean arterial pressure (MAP) < 55 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||Participants|||Count of Participants
2556381|NCT02726620|Secondary|Incidence of a MAP < 60 mmHg for > 10 Minutes|Incidence of a mean arterial pressure (MAP) < 60 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||Participants|||Count of Participants
2556382|NCT02726620|Secondary|Incidence of a MAP < 50 mmHg|Incidence of a mean arterial pressure (MAP) < 50 mmHg during anesthesia for 1 minute or more.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||Participants|||Count of Participants
2556383|NCT02726620|Secondary|Incidence of a MAP < 55 mmHg|Incidence of a mean arterial pressure (MAP) < 55 mmHg during anesthesia for 1 minute or more.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||Participants|||Count of Participants
2556384|NCT02726620|Secondary|Incidence of a MAP < 60 mmHg|Incidence of a mean arterial pressure (MAP) < 60 mmHg during anesthesia for 1 minute or more.|During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||Participants|||Count of Participants
2556385|NCT02726620|Secondary|Postoperative Rise in Creatinine Levels|Absolute values for serum creatinine before and after surgery will be compared. When multiple postoperative creatinine measurements are made, the maximum difference is reported.|Within 7 days after surgery|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). Patients with no routine postoperative creatinine measurements are excluded from the analysis.|||mg/dL||Inter-Quartile Range|Median
2556414|NCT02725866|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as at least 1 documented plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment.|Up to 24 weeks|Core population (those meeting inclusion criteria and treated according to the standard of care and w/in local label guidelines for specific disease characteristics [cirrhotic status, genotype]) who had at least 1 undetectable or unquantifiable, on-treatment HCV RNA measurement and at least 1 on-treatment or end of treatment measurement thereafter.|||percentage of participants||95% Confidence Interval|Number
2556386|NCT02726620|Secondary|Postoperative Acute Kidney Injury Stage 2|Postoperative Acute Kidney Injury (AKI), Stage II or higher according to the KDIGO criteria (Kidney Disease: Improving Global Outcomes). The staging will be based on serum creatinine values, as documentation of urine output is probably not sufficiently accurate. The creatinine measurements are part of routine clinical care. Therefore, absence of creatinine postoperative measurements are considered to be 'no suspicion of kidney injury'. KDIGO defines AKI as any of the following: Increase in serum creatinine by 0.3mg/dL or more within 48 hours or Increase in serum creatinine to 1.5 times baseline or more within the last 7 days or Urine output less than 0.5 mL/kg/h for 6 hours. Stage 1 is 1.5-9x baseline or >0.3 increase; Stage 2 is 2-2.9x baseline; Stage 3 is 3x baseline, or increase to > 4, or initiation of renal replacement therapy.|Within 7 days after surgery|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||Participants|||Count of Participants
2556387|NCT02726620|Secondary|In-hospital Mortality|Hospital mortality rate during a single hospital admission after the surgery|All postoperative days during a single hospital admission, expected median of 5 days|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||Participants|||Count of Participants
2556388|NCT02726620|Secondary|30-day Mortality|Vanderbilt University Medical Center: combination of in-hospital mortality and 'alive-index' (which checks for visits to the hospital in the electronic healthcare record as indication of being alive at 30 days)|30 days after surgery|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). For a large group of patients no mortality information was available.|||Participants|||Count of Participants
2556389|NCT02726620|Primary|Postoperative Acute Kidney Injury|Postoperative Acute Kidney Injury (AKI), Stage I or higher according to the KDIGO criteria (Kidney Disease: Improving Global Outcomes). The staging will be based on serum creatinine values, as documentation of urine output is probably not sufficiently accurate. This will be the primary outcome for the Vanderbilt University Medical Center. The creatinine measurements are part of routine clinical care. Therefore, absence of creatinine postoperative measurements are considered to be 'no suspicion of kidney injury'. KDIGO defines AKI as any of the following: Increase in serum creatinine by 0.3mg/dL or more within 48 hours or Increase in serum creatinine to 1.5 times baseline or more within the last 7 days or Urine output less than 0.5 mL/kg/h for 6 hours. Stage 1 is 1.5-9x baseline or >0.3 increase; Stage 2 is 2-2.9x baseline; Stage 3 is 3x baseline, or increase to > 4, or initiation of renal replacement therapy.|Within 7 days after surgery|Per study protocol only patients with any MAP < 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).|||Participants|||Count of Participants
2556390|NCT02726399|Primary|Progression Free Survival|as measured from the start of the ramucirumab and trastuzumab to the date of either documentation of disease progression on chemotherapy with trastuzumab and ramucirumab or death.|6 months|Data were not collected||||||
2556391|NCT02726178|Secondary|The Modifications in HRV That Can Predict the Occurrence of CRE in Preterm Infants After Immunization.|The secondary objective was to identify predictive factors of occurrence of CRE in preterm infants after immunization through the analysis of their HRV. Two annotated polysomnographies were performed for all patients with an AURA PSG GRASS ambulatory and wireless system. Each polysomnography had a duration of 2.5 hours: the first was conducted on enrolment (the day before immunization), and the second was conducted 18 to 24 hours after immunization : we compared the mean of the datas of polysomnographies after to those before immunization.|72 h||||msec||Standard Deviation|Mean
2556392|NCT02726178|Primary|The Change in the Number of CRE (Extracted From Printed Monitoring Tracings Compared to Noted Nurses' Surveillance) Following the First Dose of Pentavalent Vaccine in Preterm Infants Born < 32 Weeks Gestation After Administration of Ibuprofen.|Immunization with the pentavalent vaccine Diphtheria-Tetanus-Acellular pertussis-Inactivated poliomyelitis-Haemophilus influenzae type b (DTPa-IPV-Hib) at two months of age is known to be associated with cardio-respiratory events (CRE), in 11 to 47% of preterm infants.It is considered that the immature brainstem respiratory control of preterms make them more vulnerable to the inflammatory reaction caused by immunization. We hypothesized that post-immunization CRE are correlated with inflammatory reaction. The primary objective was to examine the impact of endogenous PG inhibition on the occurrence of CRE following the first dose of pentavalent vaccine in preterm infants born < 32 weeks gestation. Total CRE was expressed as the average number of events (desaturation + apneas + bradycardia) / 24 hours. Δ Total CRE / patient / 24 hours was defined as the difference between the average number of events / 24 hours observed before vs. after immunization for each patient.|the mean of CRE occured in the 48h after immunization minus the base line CRE : mesured 24h before immunization||||events/patient/24hours||Standard Deviation|Mean
2556393|NCT02726113|Secondary|Number of Gene Transcripts Identified Regulated by Vitamin D Supplementation in Both AA and European American Participants|"The intent of this outcome measure was to identify the number of gene transcripts found to be differentially expressed (where a difference or change has occurred) in both AA and EA subjects upon vitamin D supplementation. The transcripts differentially expressed were compared to the transcripts in the Placebo Arm/Group."|up to 8 months post prostatectomy|All study participants completed genomic analysis|||differentially expressed transcripts|Total transcripts||Number
2556394|NCT02726113|Primary|Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo).|Baseline vitamin D3 levels will be obtained at enrollment and approximately two months later during the surgical procedure (prostatectomy). These D3 levels will be evaluated for the 27 participants who had genomic analysis and compared by race (Caucasian and AA).|approximately two months from baseline to date of prostatectomy (exit)|27 participants, who had genomic analysis (RNA sequencing), were evlauated for their serum level of D3 at baseline and exit. Intervention: 9 Caucasian/5 AA and Control: 8 Caucasian/5 AA|||ng/ml||Full Range|Mean
2556395|NCT02726074|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||From the first dose of investigational product to the last visit or 28 days after the last dose (up to 1 year 11 months)|The safety set included participants who received at least one dose of investigational product and were assessed for safety at least once after study treatment.|||Participants|||Count of Participants
2556553|NCT02722577|Primary|Percent of Ablation Targets With Termination of the Clinical Ventricular Arrhythmia After RF Energy Delivery||Intraoperative, an average of 2 hours||||Participants|||Count of Participants
2556396|NCT02726074|Secondary|Percent Change From Baseline in Secondary GTC Seizure Frequency to the Titration and Maintenance Period|Percent change in the frequency of secondary GTC seizure was defined as the percent reduction in seizure frequency from baseline to Titration Period and Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain. Percent change from Baseline was calculated as: ([post-Baseline value minus the Baseline value] / Baseline value)*100. A negative percent change from baseline indicates a decrease in partial seizure frequency.|Weeks 12 and 36|The full analysis set included participants who received at least one dose of investigational product and were assessed for primary efficacy at least once after study treatment. Participants who were evaluable for this given measure at a given time point were included for this assessment.|||percent change||Full Range|Median
2556397|NCT02726074|Secondary|100% Responder Rate (Seizure Free Rate) in Secondary GTC Seizures|The 100% responder rate was defined as the percentage of participants who have at least a 100% reduction from baseline in the frequency of secondary GTC seizures during the Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain.|Baseline up to Week 36|The full analysis set included participants who received at least one dose of investigational product and were assessed for primary efficacy at least once after study treatment. Participants who were evaluable for this given measure at a given time point were included for this assessment.|||percentage of participants||95% Confidence Interval|Number
2556398|NCT02726074|Secondary|75% Responder Rate in Secondary GTC Seizures|The 75% responder rate was defined as the percentage of participants who achieved at least a 75% reduction from baseline in seizure frequency of secondary GTC seizure during the Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain.|Baseline up to Week 36|The full analysis set included participants who received at least one dose of investigational product and were assessed for primary efficacy at least once after study treatment. Participants who were evaluable for this given measure at a given time point were included for this assessment.|||percentage of participants||95% Confidence Interval|Number
2556399|NCT02726074|Secondary|50% Responder Rate in Secondary Generalized Tonic Clonic (GTC) Seizures|The 50% responder rate was defined as the percentage of participants who have achieved at least a 50% reduction from baseline in the frequency of secondary GTC seizure during the Maintenance Period. GTC seizures are defined as seizures involved with generalized stiffening and rhythmic jerking of the limbs, caused by bilateral malfunction of the brain.|Baseline up to Week 36|The full analysis set included participants who received at least one dose of investigational product and were assessed for primary efficacy at least once after study treatment. Participants who were evaluable for this given measure at a given time point were included for this assessment.|||percentage of participants||95% Confidence Interval|Number
2556400|NCT02726074|Secondary|Percent Change From Baseline in Partial Onset Seizure Frequency With or Without Secondary Generalization to the Titration and Maintenance Period|Percent change in the frequency of partial onset seizure with or without secondary generalization was defined as the percent reduction in seizure frequency from baseline to titration period and maintenance period. Percent change from Baseline was calculated as: ([post-Baseline value minus the Baseline value] / Baseline value)*100. A negative percent change from baseline indicates a decrease in partial seizure frequency.|Weeks 12 and 36|The full analysis set included participants who received at least one dose of investigational product and were assessed for primary efficacy at least once after study treatment. Participants who were evaluable for this given measure at a given time point were included for this assessment.|||percent change||Full Range|Median
2556401|NCT02726074|Secondary|100% Responder Rate (Seizure Free Rate) for Partial Onset Seizure With or Without Secondary Generalization|The 100% responder rate was defined as the percentage of participants who achieved at least 100% reduction from baseline in the frequency of partial onset seizure with or without secondary generalization during the Maintenance Period.|Baseline up to Week 36|The full analysis set included participants who received at least one dose of investigational product and were assessed for primary efficacy at least once after study treatment.|||percentage of participants||95% Confidence Interval|Number
2556402|NCT02726074|Secondary|75% Responder Rate for Partial Onset Seizure With or Without Secondary Generalization|The 75% responder rate was defined as the percentage of participants who achieved at least 75% reduction from baseline in the frequency of partial onset seizure with or without secondary generalization during the Maintenance Period.|Baseline up to Week 36|The full analysis set included participants who received at least one dose of investigational product and were assessed for primary efficacy at least once after study treatment.|||percentage of participants||95% Confidence Interval|Number
2556403|NCT02726074|Primary|50 Percent (%) Responder Rate for Partial Onset Seizure With or Without Secondary Generalization|The 50% responder rate was defined as the percentage of participants who achieved at least 50% reduction from baseline in the frequency of partial onset seizure with or without secondary generalization during the Maintenance Period.|Baseline up to Week 36|The full analysis set included participants who received at least one dose of investigational product and were assessed for primary efficacy at least once after study treatment.|||percentage of participants||95% Confidence Interval|Number
2556404|NCT02726022|Primary|Change From Baseline in SF-36 MCS at 24 Weeks After EOT|SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).|Baseline, 24 weeks after EOT (up to 72 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.|||units on a scale||Standard Deviation|Mean
2556554|NCT02722564|Primary|Change in Breath Alcohol Content Between the Estimated Level and the Actual Level as Measured by an Alco Sensor IV Device|The change was measured both when participants' breath alcohol content was ascending to 0.1 and descending to 0.08.|1 day|The number analyzed for ascending BrAC readings and descending BrAC readings|||percent blood alcohol content|BrAC readings|Standard Deviation|Median
2556405|NCT02726022|Primary|Change From Baseline in SF-36 Mental Component Summary (MCS) at EOT|SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning).|Baseline, EOT (up to 48 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction.|||units on a scale||Standard Deviation|Mean
2556406|NCT02726022|Primary|Change From Baseline in SF-36 PCS at 24 Weeks After EOT|SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).|Baseline, 24 weeks after EOT (up to 72 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.|||units on a scale||Standard Deviation|Mean
2556407|NCT02726022|Primary|Change From Baseline in SF-36 Physical Component Summary (PCS) at EOT|SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).|Baseline, EOT (up to 48 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction.|||units on a scale||Standard Deviation|Mean
2556408|NCT02726022|Primary|Change From Baseline in SF-36 General Health Domain at 24 Weeks After EOT|SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).|Baseline, 24 weeks after EOT (up to 72 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 56; participants evaluable for Drug Addiction = 56. Same participants could be evaluated under Gender and Drug Addiction.|||units on a scale||Standard Deviation|Mean
2556409|NCT02726022|Primary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) General Health Domain at End of Treatment (EOT)|SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for general health domain was an average of the individual question scores of this domain, which are scaled 0-100 (100=highest level of functioning). Data was reported by status of gender (male and female) and drug addiction (yes and no).|Baseline, EOT (up to 48 weeks)|Analysis population included all enrolled participants. Number of participants analyzed = participants with evaluable data. Participants evaluable for Gender = 76; participants evaluable for Drug Addiction = 75. Same participants could be evaluated under Gender and Drug Addiction.|||units on a scale||Standard Deviation|Mean
2556410|NCT02725866|Secondary|Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria|The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response was documented.|12 weeks after the last actual dose of study drug|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants|||Number
2556411|NCT02725866|Secondary|Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria|Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure.|12 weeks after the last actual dose of study drug|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants|||Number
2556412|NCT02725866|Secondary|Percentage of Participants Meeting Relapse Criteria|Relapse was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment.|12 weeks after the last actual dose of study drug|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants|||Number
2556413|NCT02725866|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as breakthrough (at least 1 documented plasma hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL).|12 weeks after the last actual dose of study drug|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants|||Number
2556417|NCT02725866|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|"SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria:~evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN~an HCV RNA value ≥50 IU/mL at the last measurement post-baseline~HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure"|12 weeks after the last actual dose of study drug|Core population (CP) and core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) are defined in the outcome measure description.|||percentage of participants||95% Confidence Interval|Number
2556418|NCT02725788|Primary|Dressing Wear Time|Dressing wear time is the time from dressing application to removal, i.e. catheter no longer needed or catheter-related complication occurs (remove dressing and catheter) OR excessive dressing lift requiring dressing replacement.|Dressing wear time was assessed daily and 8 month dressing wear data are presented|All subjects randomized except three subjects who either failed to have a study dressing applied or whom could not have the primary endpoint ascertained.|||Days||Full Range|Median
2556419|NCT02725710|Secondary|General Satisfaction With the Procedure (on a 5-point Scale)||Post-operative day 1|Data not collected.||||||
2556420|NCT02725710|Secondary|Side Effects (on a 5-point Scale)||Post-operative day 1|Data not collected.||||||
2556421|NCT02725710|Secondary|Vomiting (on a 5-point Scale)||Post-operative day 1|Data not collected.||||||
2556422|NCT02725710|Secondary|Nausea (on a 5-point Scale)||Post-operative day 1|Data not collected.||||||
2556423|NCT02725710|Secondary|Pain (on a 5-point Scale)||Post-operative day 1|Data not collected.||||||
2556424|NCT02725710|Secondary|Number of Subjects Experiencing Side Effects|Side effects noted are dizziness, ataxia, somnolence, asthenia, headache, and amblyopia.|10 minutes post-procedure||||Participants|||Count of Participants
2556425|NCT02725710|Secondary|Number of Subjects Using Pain Medications|Pain medications included ibuprofen and oxycodone.|24 hours post-operatively|"The number of subjects analyzed for ibuprofen and oxycodone and oxycodone only reflects the number of subjects that received a prescription for opiates."|||Participants|||Count of Participants
2556426|NCT02725710|Secondary|Perioperative Anxiety as Measured by the 100-mm VAS|Score range of 0 to 100, where 0 means no anxiety and 100 means extremely anxious.|5 minutes, 10 minutes, 30 minutes, discharge|One subject in the placebo group did not have anxiety at discharge measured.|||units on a scale||Inter-Quartile Range|Median
2556427|NCT02725710|Secondary|Number of Subjects Experiencing Perioperative Vomiting||Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes||||Participants|||Count of Participants
2556428|NCT02725710|Secondary|Perioperative Nausea as Measured by 100-mm VAS|Score range of 0 to 100, where 0 means no nausea and 100 means worst nausea in my life.|Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes||||units on a scale||Inter-Quartile Range|Median
2556429|NCT02725710|Secondary|Pain Score on the 100-mm VAS|Measured at baseline, 10 minutes post-procedure, and 30 minutes post-procedure. Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.|Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute||||units on a scale||Inter-Quartile Range|Median
2556430|NCT02725710|Primary|Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure|Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.|5 minutes||||score on a scale||Standard Deviation|Mean
2556431|NCT02725671|Secondary|Risk of Hospitalization|Incidence of hospitalization at follow up|5 years after enrollment|||||||
2556432|NCT02725671|Secondary|Risk of Revascularization at Follow up|Incidence of revascularization at follow up|5 year after enrollment|||||||
2556433|NCT02725671|Secondary|Risk of Myocardial Infarction|Incidence of myocardial infarction at follow up|5 years after enrollment|||||||
2556434|NCT02725671|Secondary|Incidence of Death at Follow up|Patient follow up data will be used to performance of CGM to identify patients who are at risk of suffering adverse cardiac events at follow up compared to coronary CT angiography using AUC analysis.|5 years after enrollment|||||||
2556435|NCT02725671|Secondary|Accuracy of Identifying Patients With Any Coronary Atherosclerotic Disease by CT Angiography|Area under the curve (AUC) analysis is proposed to be used to asses the diagnostic accuracy of CGM for identifying patients with any coronary atherosclerotic disease|30 days|||||||
2556436|NCT02725671|Primary|Accuracy of Identifying Patients With at Least One 50 Percent or Greater Coronary Artery Stenosis by CT Angiography|Area under curve (AUC) analysis is proposed to be used to determine the diagnostic accuracy of cardiogoniometry for detecting patients with coronary heart disease as defined by at least one 50% or greater stenosis on CT coronary angiography.|30 days from CGM analysis|Minimum data needed for this measure was not collected and therefore could not be calculated.||||||
2556437|NCT02725645|Primary|Muscle Activity as a Measure of Route Mean Square|EMG signals were initially filtered with a Notch Filter of 50hz, due to the DC power line, using MATLAB 7.11 (v.2010). The signal was then detrended, converted into millivolts and normalized. the normalized signal was then used to calculate the route mean square.|one year||||milivolts||Standard Deviation|Mean
2556449|NCT02724787|Primary|Overt Aggression Scale|The Overt Aggression Scale (OAS) is a 17-item self-report measure that assesses frequency of different aggression acts, including verbal and physical aggression against self, other, and objects. Theoretical minimum score = 0; there is no bounded maximum value. Higher values = greater frequency of aggression.|Given 3 weeks after last MERA session. Assess aggressive events in past week.|22 participants completed the treatment. 20 participants returned for the post-treatment assessment.|||events||Standard Deviation|Mean
2556555|NCT02722330|Other Pre-specified|Number of Adverse Events Related to the Treatment|Number of adverse events related to the treatment during the 12 weeks treatment period|12 weeks||||events|||Number
2556438|NCT02725515|Secondary|Time to Loss of Systemic Lupus Erythematosus Disease Activity Improvement Achieved by a Short Period of IM Steroid Therapy in SLE Patients|"Loss of improvement was defined as worsening of disease activity that in the opinion of the principal investigator requires a change in treatment (exclusive of a decrease in oral steroids) AND one of:~SELENA- SLEDAI increase of >=4 points from maximal improvement OR~Worsening of at least 1 BILAG A or B score OR~New BILAG A or B score."|From the date of randomization until the date of loss of Systemic Lupus Erythematosus Disease Activity Improvement, or the date of the final efficacy assessment, up to 239 days.|"Efficacy Evaluable Population: All patients who:~Complete study through Day 225 assessments~Discontinue due to reaching the protocol specified LOI endpoint (and have not missed 2 or more consecutive doses prior to the LOI visit)~Discontinue due to drug-related adverse event (nonresponder)"|||days||95% Confidence Interval|Median
2556439|NCT02725515|Secondary|Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 169|Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 169|Day 169|"Efficacy Evaluable Population: All patients who:~Complete study through Day 225 assessments~Discontinue due to reaching the protocol specified LOI endpoint (and have not missed 2 or more consecutive doses prior to the LOI visit)~Discontinue due to drug-related adverse event (nonresponder)"|||Participants|||Count of Participants
2556440|NCT02725515|Primary|Percentage of Patients Without Loss of Systemic Lupus Erythematosus Disease Activity Improvement on Day 225|Landmark proportion of patients without loss of systemic lupus erythematosus disease activity improvement on Day 225|Day 225|"Efficacy Evaluable Population: All patients who:~Complete study through Day 225 assessments~Discontinue due to reaching the protocol specified LOI endpoint (and have not missed 2 or more consecutive doses prior to the LOI visit)~Discontinue due to drug-related adverse event (nonresponder)"|||Participants|||Count of Participants
2556441|NCT02725476|Secondary|Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3|The number of patients experiencing a treatment-emergent adverse event as assessed by CTCAE v4.3 will be tabulated according to MedDRA system-organ class and preferred term, intensity and causality.|Baseline Day 1 to Day 197|Safety Population: All patients who receive at least a partial dose of XmAb5871.|||Participants|||Count of Participants
2556442|NCT02725476|Primary|Proportion of Patients With an Improvement in IgG4-RD Activity|Improvement of disease activity as defined by a decrease of IgG4-RD responder index >= 2 points from Day 1 pre-dose disease activity score. The IgG4-RD Responder Index Total Activity Score ranges from 0 to a maximum of 162. Higher scores represent greater (i.e. worse) disease activity. A score of 0 represents no disease activity other than residual fibrosis.|Baseline Day 1 to Day 169|Intent to Treat (ITT) Population: All patients who have received at least a partial dose of XmAb5871.|||Participants|||Count of Participants
2556443|NCT02725008|Secondary|Change in Symptom Severity From Day 1 to Day 5|Severity of asthma symptoms as reported by the Patient Self Assessment Score. Patients assessed severity of asthma symptoms in 4 categories (wheezing, coughing, activity and sleep) once per day during the 5 days between study enrollment and follow-up. Score range is 0 - 12 with 0 being mildest symptoms and 12 being most severe symptoms. Reported as change in score between enrollment (day 1) and follow-up (day 5).|5 days|Participants who had complete data available for analysis|||score on a scale||Standard Deviation|Median
2556444|NCT02725008|Primary|Treatment Failure|number of patients who experience any of the following outcomes - unplanned hospital admission for asthma symptoms, unplanned ED visit for asthma symptoms, unplanned urgent care visit for asthma symptoms, unplanned primary care physician visit for asthma symptoms, or prescription of a course of steroids|5 days||||Participants|||Count of Participants
2556445|NCT02724787|Primary|Exit Interview - Use of Skills|"The exit interview was created by the study team and has 8 questions that asks: 1.) Are you using _____skill?. Scores = percentage of the sample that was using the skill during the week before the post treatment assessment. Percentages could range from 0% to 100% of the sample. Higher scores represent more of the sample using the skill."|Given 3 weeks after last MERA session. Assess emotion regulation strategies used in past week.|22 participants completed the treatment. 20 participants returned for the post-treatment assessment.|||Participants|||Count of Participants
2556446|NCT02724787|Primary|Exit Interview - Ratings of Therapist and Treatment|"The exit interview was created by the study team and has 3 questions that asks: 1.) how understanding the therapist was, 2.) how helpful the therapist was in learning skills, and 3.) how helpful MERA was in managing emotions.~Scale for all questions:~1 = Not at all understanding / helpful~2 = A little bit understanding / helpful~3 = Moderately understanding / helpful~4 = Very understanding / helpful Higher scores reflect greater understanding or helpfulness."|Given 3 weeks after last MERA session.|22 participants completed the treatment. 20 participants returned for the post-treatment assessment.|||score on a scale||Standard Deviation|Mean
2556447|NCT02724787|Primary|Emotion Regulation Questionnaire|ERQ is a 10-item self-report measure with 2 factors that assess specific emotion regulation strategies: cognitive reappraisal (6 items; changing the way one thinks about a situation) and expressive suppression (4 items; not expressing the emotion outwardly but feeling it internally). More effective emotion regulation is indicated by higher cognitive reappraisal scores and lower expressive suppression scores. Theoretical minimum score for cognitive reappraisal = 6; theoretical maximum score = 42. Theoretical minimum score for expressive suppression = 4; theoretical maximum score = 28.|Given 3 weeks after last MERA session. Assess emotion regulation strategies used in past week.|22 participants completed the treatment. 20 participants returned for the post-treatment assessment.|||score on a scale||Standard Deviation|Mean
2556448|NCT02724787|Primary|Total Score Difficulties in Emotion Regulation Scale|The Difficulties in Emotion Regulation Scale (DERS) is a 36- item self-report measure with 6 different emotion-dysregulation factors: nonacceptance of emotional responses, difficulties engaging in goal-directed behaviors, impulse-control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Total score was used in this study. Theoretical minimum value = 36; theoretical maximum value = 180. Higher scores indicate worse emotion regulation.|Given 3 weeks after last MERA session. Assess emotion dysregulation in past month.|22 participants completed the treatment. 20 participants returned for the post-treatment assessment.|||score on a scale||Standard Deviation|Mean
2556556|NCT02722330|Secondary|Daily Use of Sound Processor (Average Daily Use During the Last Week)|Average daily use (hours/day) of the sound processor during the last week of the study|12 weeks||||hours/day||Standard Deviation|Mean
2556450|NCT02724644|Secondary|Change in the Hexsel Cellulite Severity Scale (CSS) Total Score|Investigator used the Hexsel CSS to assess the severity of cellulite. The total score could range from 0 (no cellulite) to 15 (extremely severe cellulite). Negative change in Hexsel CSS total score indicates an improvement in cellulite severity|Baseline, Day 71|Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||units on a scale||Standard Deviation|Mean
2556451|NCT02724644|Secondary|Subject Satisfaction Assessment Based on the the Subject Satisfaction Scale|At Day 71, subjects were asked to rate their satisfaction with cellulite treatment using the 5-point subject satisfaction scale. Ratings could be satisfied (+1), very satisfied (+2), neither satisfied nor dissatisfied (0), or dissatisfied (-1), very dissatisfied (-2).|Day 71|Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||Participants|||Count of Participants
2556452|NCT02724644|Secondary|Subject Assessment of Improvement Based on the Subject Global Aesthetic Improvement Scale (S-GAIS)|At Day 71, subjects were asked to rate their opinion of the overall improvement of their treated area using the 7-point S-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3)|Day 71|Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||Participants|||Count of Participants
2556453|NCT02724644|Secondary|Investigator Assessment of Improvement Based on the Investigator Global Aesthetic Improvement Scale (I-GAIS)|On Day 71, the Investigator determined the degree of improvement from baseline in the treated area using the 7-point I-GAIS. Ratings could be improved (+1), much improved (+2), or very much improved (+3), or no change (0), or worse (-1), much worse (-2) or very much worse (-3).|Day 71|Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||Participants|||Count of Participants
2556454|NCT02724644|Secondary|PR-PCSS Change From Baseline|The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity.|Baseline, Day 71|Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||units on a scale||Standard Deviation|Mean
2556455|NCT02724644|Secondary|PR-PCSS Responder Analysis: 1-Level of Severity|Percentage of subjects with improvement from baseline of at least 1-level of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement would be for example a change from 4 (severe) to 3 (moderate).|Baseline, Day 71|Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||Participants|||Count of Participants
2556456|NCT02724644|Secondary|PR-PCSS Responder Analysis: 2-Levels of Severity|Percentage of subjects with improvement from baseline of at least 2-levels of severity on the subject-rated Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) at Day 71.The PR-PCSS is a photonumeric scale that was used by the subject to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement would be for example a change from 4 (severe) to 2 (mild).|Baseline, Day 71|Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||Participants|||Count of Participants
2556457|NCT02724644|Secondary|CR-PCSS Change From Baseline|The CR-PCSS is a photonumeric scale that was used by the investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). Change is Day 71 study visit rating minus baseline visit; negative values indicate a lessening in cellulite severity.|Baseline, Day 71|Analysis is based on mITT population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||units on a scale||Standard Deviation|Mean
2556458|NCT02724644|Secondary|CR-PCSS Responder Analysis: 1-Level of Severity|Percentage of subjects with improvement from baseline of at least 1-level of severity on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at Day 71.The CR-PCSS is a photonumeric scale that was used by the investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement would be for example a change from 4 (severe) to 3 (moderate).|Baseline, Day 71|Analysis is based on modified intent-to-treat (mITT) population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||Participants|||Count of Participants
2556459|NCT02724644|Secondary|CR-PCSS Responder Analysis: 2-Levels of Severity|Percentage of subjects with improvement from baseline of at least 2-levels of severity on the Investigator-rated Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) at Day 71.The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement would be for example a change from 4 (severe) to 2 (mild).|Baseline, Day 71|Analysis is based on modified intent-to-treat (mITT) population; all randomized subjects who received at least 1 injection of study medication and had at least 1 post-injection evaluation of both CR-PCSS by investigator and PR PCSS|||Participants|||Count of Participants
2556471|NCT02723786|Secondary|ADA Titer Before and After GSK1070806 Administration|Serum samples were to be collected to test for the presence of antibodies against GSK1070806 at indicated time points. The presence of ADA titre was to be assessed using a validated ECL immunoassay.|0.75 hour and 4-8 hour on Day 0, Day 1, Day 2, Day 30, Day 90, 6 months and 12 months post reperfusion|All Subjects Population. Data was not collected as the immunogenicity samples were not collected for this terminated indication since healthy volunteers showed low titers and Type 2 Diabetics showed no titers per Investigator's Brochure.||||||
2556460|NCT02724644|Secondary|Percentage of Composite Responders of at Least 1-Level Improvement of Severity|Percentage of composite responders defined as subjects with improvement from baseline of at least 1-level of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 1-level improvement on each scale for example would represent a change from a 4 (severe) to a 3 (moderate). In order to be considered a responder a subject needs to have at least a 1-level improvement on both scales.|Baseline, Day 71|Analysis is based on ITT population; all randomized subjects who received at least 1 injection of study medication|||Participants|||Count of Participants
2556461|NCT02724644|Primary|Percentage of Composite Responders of at Least 2-Level Improvement of Severity|Percentage of composite responders defined as subjects with an improvement from baseline of at least 2-levels of severity on each, the Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), at Day 71 in the ITT population. The CR-PCSS is a photonumeric scale that was used by the Investigator to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). The PR-PCSS is a photonumeric scale that was used by the subjects to evaluate cellulite ranging from 0 (none), 1 (almost none), 2 (mild), 3 (moderate), to 4 (severe). A 2-level improvement on each scale for example would represent a change from a 4 (severe) to a 2 (mild). In order to be considered a responder a subject needs to have at least a 2-level improvement on both scales.|Baseline, Day 71|Analysis is based on ITT population; all randomized subjects who received at least 1 injection of study medication|||Participants|||Count of Participants
2556462|NCT02724449|Primary|Number of Participants With Change in Incontinence Associated Dermatitis Score|"Patients who were experiencing Incontinence Associated Dermatitis (IAD) from exposure to urine, stool or a combination of both urine & stool received an application of the barrier film every 72 hours. A skin assessment tool designed for IAD was used to document each patient's IAD score over time. The area scored was divided into 6 zones, l & r buttocks, L & right thighs, perianal & gluteal cleft. The % area within each zone with denudement was X by 9, redness was X by 3 and healthy skin X 1. The total score range of the 6 zones was 0-3654 with 3654 being worst case scenario.~Improvement of IAD Score - At baseline (enrollment) the six zones were evaluated for % of denudement, redness, pink and healthy skin assessed. At the end of subject's participation, assessment were completed again to determine final score & change for improvement was measured by reduction in IAD score No improvement of IAD score - No change in score Progression of IAD score - Increase in IAD score"|Baseline and end of treatment (up to 3 weeks)||||participants|||Number
2556463|NCT02724111|Secondary|Adverse Events : The Postoperative Nausea and Vomiting Occurrence in Subject|The occurrence of any adverse events was recorded in the post-anesthesia care unit (PACU) and a ward during the postoperative 24 hours.|during the postoperative 24 hours||||Participants|||Count of Participants
2556464|NCT02724111|Secondary|Recovery Time (Time to Reach Sedation Score 5 at Postanesthesia Care Unit (PACU).|the time to reach sedation score 5 (the Observer's Assessment of Alertness/ Sedation (OAA/S) score; awake, 5 to unresponsive, 1) at PACU|every 10 min for 1 hour at PACU.||||minute||Standard Deviation|Mean
2556465|NCT02724111|Secondary|The Degree of Bleeding|2.The degree of bleeding of each patient scaled by surgeons (Intraoperative scale for assessment of operating condition of surgical field: 0 - No bleeding, 1 - Slight bleeding - no suctioning of blood required, 2 - Slight bleeding - occasional suctioning required but not threatened the operative field, 3 ‑ Slight‑bleeding - frequent suctioning of blood was required that threatens the operative field a few seconds after suctioning, 4 - Moderate bleeding - frequent suctioning of blood was required which threatens the operative field directly after suctioning, 5 - Severe bleeding - continuous suctioning of blood was required which severely threatened the operative field make the surgery not possible).|Continuously observed during the whole period of surgery, up to 3 hours||||Scores on a scale (NRS; 0-5)||Standard Deviation|Mean
2556466|NCT02724111|Secondary|The Number of Body Movements|The number of body movements (including cough or any diaphragm movement) observed during the surgery.|At the occurrence of the event during surgery, up to 3 hours||||number of event||Standard Deviation|Mean
2556467|NCT02724111|Secondary|The Muscle Tone|The muscle tone of each patient at the screw insertion through the pedicle of spine during surgery scaled by surgeons (1: muscle tone is good, suitable for surgery; 2: muscle tone is moderate, but do not affect the operation; 3: muscle tone is hard, making the operation difficult.).|at the screw insertion through the pedicle of spine during surgery||||Scores on a scale (NRS; 1-3)||Standard Deviation|Mean
2556468|NCT02724111|Secondary|Overall Satisfaction of Surgeons for the Surgical Condition|Overall satisfaction of surgeons for the surgical condition will be assessed by the surgeons who perform surgery using numerical rating scale (NRS; 1-10) after surgery (1, worst; 10, best).|After surgery||||Scores on a scale (NRS; 1-10)||Standard Deviation|Mean
2556469|NCT02724111|Secondary|Mean Value of Pressure of Back Muscle Retractor|Mean value of pressure of back muscle retractor placed in the operating site (recorded every 15 minutes during the placement of the retractor): measured by the pressure probe placed between the retractor and the back muscle.|Every 15 minutes at the period of the retractor placement during surgery, up to 2 hours﻿||||mmHg||Standard Deviation|Mean
2556470|NCT02724111|Primary|Mean Value of Peak Inspiratory Pressure|This outcome is the mean value of the peak inspiratory pressure measured at each 15 minute during the anesthesia, which can reflect the degree of the tone of respiratory muscles. As muscle tone increases, airway pressure usually increases due to increased tone of abdominal muscle and respiratory muscles including diaphragm. The longer the surgery goes, the higher the airway pressure gets. Also, as neurospinal surgeries are operated in the prone position, the potential for increased airway pressure is high. As airway pressure gets higher, intrathoracic pressure and intraabdominal pressure also become higher. These consequences may bring about similar results with detrimental effects derived from marked increase in intraabdominal pressure in laparoscopic abdominal surgeries|Every 15 minutes during anesthesia, up to 3 hours﻿||||cmH2O||Standard Deviation|Mean
2556557|NCT02722330|Secondary|Sound Processor Magnet Selection at 12 Weeks|Information about sound processor magnet selection, type of SP magnet|12 weeks||||Participants|||Count of Participants
2556472|NCT02723786|Secondary|Number of Participants With Positive Result in Anti-GSK1070806 Antibodies (ADAs)|Serum samples were to be collected to test for the presence of antibodies against GSK1070806 at indicated time points. The presence of anti-GSK1070806 binding antibodies were to be assessed using a validated electrochemiluminescent (ECL) immunoassay.|0.75 hour and 4-8 hour on Day 0, Day 1, Day 2, Day 30, Day 90, 6 months and 12 months post reperfusion|All Subjects Population. Data was not collected as the immunogenicity samples were not collected for this terminated indication since healthy volunteers showed low titers and Type 2 Diabetics showed no titers per Investigator's Brochure.||||||
2556473|NCT02723786|Secondary|Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant|IL-18 is itself rapidly secreted from intracellular stores following inflammasome mediated-activation. The appearance of IL-18 marks the initiation of the inflammatory response leading to further injury. Blood samples were collected at indicated time points to assess serum levels of free, total, and GSK1070806 bound IL-18. Baseline value was the latest pre-dose assessment value. Change from Baseline was post Baseline value minus Baseline value.|Baseline and at 0.75 hours, 4-8 hours, Day 1, Day 2, Day 30, Day 90, 6 months and 12 months post reperfusion|All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Picograms per milliliter||Standard Deviation|Mean
2556474|NCT02723786|Secondary|Area Under the Plasma Concentration Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUC[0-t]) and AUC From Time 0 to Infinite Time (AUC[0-inf]) of GSK1070806|Blood samples were collected to evaluate PK of GSK1070806 at Pre-operative, 0.75 hours, 4-8 hours, 24 hours, 168 hours, Day 30, Day 90, 6 months and 12 months after kidney reperfusion. Log-transformed geometric mean and 95% confidence interval have been presented.|Pre-operative, 0.75 hours, 4-8 hours, 24 hours, 168 hours, Day 30, Day 90, 6 months and 12 months after kidney reperfusion|PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Log (Hour*nanograms per milliliter)||95% Confidence Interval|Geometric Mean
2556475|NCT02723786|Secondary|Maximum Plasma Concentration (Cmax) of GSK1070806|Serial blood samples were collected to evaluate PK of GSK1070806 at Pre-operative, 0.75 hours, 4-8 hours, 24 hours, 168 hours, Day 30, Day 90, 6 months and 12 months after kidney reperfusion. Log-transformed geometric mean and 95% confidence interval have been presented.|Pre-operative, 0.75 hours, 4-8 hours, 24 hours, 168 hours, Day 30, Day 90, 6 months and 12 months after kidney reperfusion|PK Population|||Log (nanograms per milliliter)||95% Confidence Interval|Geometric Mean
2556476|NCT02723786|Secondary|Serum Concentrations of GSK1070806|Serial blood samples were collected to evaluate PK of GSK1070806 at Pre-operative, 0.75 hours, 4-8 hours, 24 hours, 168 hours, Day 30, Day 90, 6 months and 12 months after kidney reperfusion. PK Population included participants in the 'All Subjects' Population for whom a serum PK sample is obtained and analyzed for GSK1070806.|Pre-operative, 0.75 hours, 4-8 hours, 24 hours, 168 hours, Day 30, Day 90, 6 months and 12 months after kidney reperfusion|PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Nanograms per milliliter||Standard Deviation|Mean
2556477|NCT02723786|Secondary|Number of Participants Having Infections|Number of participants having infections were summarized.|Up to 12 months|All Subjects Population|||Participants|||Count of Participants
2556478|NCT02723786|Secondary|Number of Participants Having Any Abnormality of Potential Clinical Importance of Vital Signs Results|Vital signs parameters included analysis of systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and body temperature. Number of participants with any abnormality of potential clinical importance (high or low) in any of these vitals signs at any time post Baseline visit have been presented. PCI (high or low) was considered if SBP (low: <85, high:>160), DBP (low: <45, high>100), HR (low: <40, high: >110) and temperature (low: <35.5, high: >37.5).|Up to 12 months|All Subjects Population|||Participants|||Count of Participants
2556479|NCT02723786|Secondary|Number of Participants Having Any Abnormal Clinical Chemistry Results of Potential Clinical Importance|Blood samples were collected to evaluate clinical chemistry parameters. Number of participants with abnormal chemistry results of potential clinical importance (high or low) in any of these parameters at any time post Baseline visit have been presented. PCI (high or low) was considered if albumin (low<30), calcium (low<2, high>2.75), creatinine (high: CHB>44.2 increase), glucose (low<3, high>9), magnesium (low<0.5, high>1.23), phosphorus (low<0.8, high>1.6), potassium (low<3, high>5.5), sodium (low: 130, high>150), Total carbon dioxide (CO2) (low:18, high>32), Alanine aminotransferase (ALT) (high>=2*upper limit of normal [ULN]), Aspartate aminotransferase (AST) (high: >=2*ULN), Alkaline phosphatase (ALP) (high:>=2*ULN), Total bilirubin (high: >2*ULN), Total bilirubin+ALT (high: 1.5*ULN total bilirubin with >=2*ULN ALT).|Up to 12 months|All Subjects Population|||Participants|||Count of Participants
2556480|NCT02723786|Secondary|Number of Participants Having Any Abnormality in Hematology Results of Potential Clinical Importance|Blood samples were collected to evaluate hematology parameters. Number of participants with abnormality in any hematology parameter results of potential clinical importance (high or low) observed at any time post Baseline are presented. PCI (high or low) was considered if hematocrit (high:>0.54;low:change from baseline [CFB] 0.075 decrease), hemoglobin (high:180; low: CFB 25 decrease), lymphocytes (low: 0.8), neutrophil count (low: 1.5), platelet count (low: 100; high: 550), White blood cells (low: 3; high:20).|Up to 12 months|All Subjects Population|||Participants|||Count of Participants
2556481|NCT02723786|Secondary|Number of Participants With Adverse Event (AE) and Serious Adverse Event (SAE)|AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE.|Up to 12 months|All Subjects Population|||Participants|||Count of Participants
2556482|NCT02723786|Secondary|Number of Participants Who Are Dialysis Independent at Visits up to 12 Months Post-transplant|Number of participants who are dialysis independent at visits up to 12 months post transplant was evaluated to assess the effect of GSK1070806 on dialysis dependency and graft survival.|Up to 12 months|All Subjects Population|||Participants|||Count of Participants
2556558|NCT02722330|Secondary|Sound Processor Magnet Selection at 6 Weeks|Information about sound processor magnet selection, type of SP magnet|6 weeks||||Participants|||Count of Participants
2556483|NCT02723786|Secondary|Number of Participants With Dialysis Events in the First 30 Days Post-transplant|Number of participants with dialysis events in the first 30 days post transplant was evaluated to assess the effect of GSK1070806 on dialysis dependency and graft survival. The AP Population is defined as participants having Baseline and at least one post-Baseline assessment.|Up to 30 days|AP Population|||Participants|||Count of Participants
2556484|NCT02723786|Secondary|Serum Interferon Gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma Interferon (Mig) Levels at Baseline and Change From Baseline Over Time Post Transplant|The interferon-gamma -inducible chemokine IP10 and the interferon-gamma -inducible chemokine Mig have been identified as an early predictive marker of antibody-mediated kidney graft rejection. Baseline value was the latest pre-dose assessment value. Change from Baseline was calculated as post Baseline value minus Baseline value.|Baseline and at 0.75 hours, 4-8 hours, Day 1, Day 2, Day 30, Day 90, 6 months and 12 months post reperfusion|All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Picograms per milliliter||Standard Deviation|Mean
2556485|NCT02723786|Secondary|Number of Participants With Episodes of Biopsy-proven Acute Rejection|Number of participants with episodes of biopsy-proven acute rejection were evaluated to assess the effect of GSK1070806 on acute rejection risk, and rejection/Pharmacodynamic (PD) biomarkers.|Up to 12 months|All Subjects Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2556486|NCT02723786|Secondary|Number of Participants in the First 7 Days With: Primary Non Function, Functional DGF, Intermediate Graft Function, Immediate Graft Function|Number of participants in the first 7 days with primary non function, functional DGF, intermediate graft function and immediate graft function were evaluated to access graft function in DCD renal transplant recipients treated with GSK1070806. The AP Population is defined as participants in the 'All Subjects' Population who have been declared to have DGF or have reached 7 days.|Up to Day 7|All Subjects Population|||Participants|||Count of Participants
2556487|NCT02723786|Secondary|Urine Volume at Baseline and Change From Baseline Over Time Post Transplant|Urine volume at Baseline and over time post transplant was measured to assess graft function in DCD renal transplant recipients treated with GSK1070806. Baseline value was the latest pre-dose assessment value. Change from Baseline was post Baseline value minus Baseline value. All Subjects Population comprised of participants who received the dose of study medication.|Baseline (Pre-operative) and up to Day 28|All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Liter||Standard Deviation|Mean
2556488|NCT02723786|Secondary|Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant|Blood samples were collected to measure serum creatinine at the indicated timepoints to assess graft function in DCD renal transplant recipients treated with GSK1070806. Baseline value was the latest pre-dose assessment value. Change from Baseline was post Baseline value minus Baseline value. NA indicates data is not available as standard deviation could not be calculated due to n=1. The AP Population is defined as participants having Baseline and at least one post-Baseline assessment.|Baseline and up to 12 months|AP Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2556489|NCT02723786|Primary|Number of Participants Requiring Dialysis During the First 7 Days Post Transplant|The requirement of dialysis (except as needed for hyperkalaemia during the first 24 hours [hrs]) were used to assess the frequency of delayed graft function (DGF) in donation after circulatory death (DCD) renal transplant recipients treated with GSK1070806. The 'Analysis Population' (AP) is defined as participants in the 'All Subjects' Population who have been declared to have DGF or have reached 7 days.|Up to Day 7|AP Population|||Participants|||Count of Participants
2556490|NCT02723630|Secondary|Number of Participants With Non-Serious Treatment-Emergent Adverse Events (TEAEs) and Serious Treatment-Emergent Adverse Events as a Measure of Safety and Tolerability of Lenvatinib|Safety assessments consisted of monitoring and recording all adverse events (AEs) (serious and non-serious); regular monitoring of hematology, blood chemistry and urine values; periodic measurement of vital signs and electrocardiograms, performance of physical examinations. A TEAE was defined as an AE that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. TEAEs considered by the investigator to be possibly or probably related to study drug, or TEAEs with missing causality, were included.|From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months|Safety analysis set (SAS) included the group of participants who received at least one dose of study drug and had at least one postdose safety assessment.|||Percentage of participants|||Number
2556491|NCT02723630|Secondary|Terminal Elimination Phase Half-life (t1/2)|Blood samples (6 mL each) were collected at the following time points for each Period: 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose. The window for 0 to 12 hours was +/-2 minutes, for 24 hours was +/-5 minutes and for >24 hours was equal to +/-15 to 60 minutes. Plasma concentrations of lenvatinib were quantified by LC-MS/MS methodology using a previously validated assay. The LLOQ for the assay was 0.25 ng/mL.|Periods 1, 2, and 3; 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose|PK analysis set|||Hours||Standard Deviation|Mean
2556492|NCT02723630|Secondary|Time to Cmax (Tmax) for Lenvatinib|Blood samples (6 mL each) were collected at the following time points for each Period: 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose. The window for 0 to 12 hours was +/-2 minutes, for 24 hours was +/-5 minutes and for >24 hours was equal to +/-15 to 60 minutes. Plasma concentrations of lenvatinib were quantified by LC-MS/MS methodology using a previously validated assay. The LLOQ for the assay was 0.25 ng/mL.|Periods 1, 2, and 3; 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose|PK analysis set|||Hours||Full Range|Median
2556506|NCT02723188|Secondary|Self-reported Fear Rankings|"Participants marked how fearful they are of stimuli used in the task on a single 10-point scale (1=not afraid, 10=extremely afraid). Higher scores therefore reflect greater fear and are worse in the context of treatment for anxiety disorders.~Scores were collected in response to presentation of the CS+ (the stimulus conditioned to be associated with an aversive outcome) and the CS- (the stimulus not conditioned to be associated with any outcome)."|During three-day experimental task||||units on a scale||Standard Deviation|Mean
2556493|NCT02723630|Secondary|Maximum Observed Concentration (Cmax) of Lenvatinib in Plasma|Blood samples (6 mL each) were collected at the following time points for each Period: 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose. The window for 0 to 12 hours was +/-2 minutes, for 24 hours was +/-5 minutes and for >24 hours was equal to +/-15 to 60 minutes. Plasma concentrations of lenvatinib were quantified by LC-MS/MS methodology using a previously validated assay. The LLOQ for the assay was 0.25 ng/mL.|Periods 1, 2, and 3; 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose|PK analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2556494|NCT02723630|Secondary|Area Under the Concentration-Time Curve From Zero Time (Predose) to 72 Hours (AUC(0-72))|Blood samples (6 mL each) were collected at the following time points for each Period: 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose. The window for 0 to 12 hours was +/-2 minutes, for 24 hours was +/-5 minutes and for >24 hours was equal to +/-15 to 60 minutes. Plasma concentrations of lenvatinib were quantified by LC-MS/MS methodology using a previously validated assay. The LLOQ for the assay was 0.25 ng/mL.|Periods 1, 2, and 3; 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, and 72 hours postdose|PK analysis set|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
2556495|NCT02723630|Primary|Area Under the Concentration-Time Curve From Zero Time (Predose) to 24 Hours (AUC(0-24))|Blood samples (6 mL each) were collected at the following time points for each Period: 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose. The window for 0 to 12 hours was +/-2 minutes, for 24 hours was +/-5 minutes and for >24 hours was equal to +/-15 to 60 minutes. Plasma concentrations of lenvatinib were quantified by LC-MS/MS methodology using a previously validated assay. The LLOQ for the assay was 0.25 ng/mL.|Periods 1, 2, and 3; 0 (Predose), 1, 2, 3, 4, 8, 12, and 24 hours postdose|PK analysis set|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
2556496|NCT02723630|Primary|Area Under the Concentration-Time Curve From Zero Time (Predose) Extrapolated to Infinite Time (AUC(0-inf))|Blood samples (6 mL each) were collected at the following time points for each Period: 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose. The window for 0 to 12 hours was +/-2 minutes, for 24 hours was +/-5 minutes and for >24 hours was equal to +/-15 to 60 minutes. Plasma concentrations of lenvatinib were quantified by LC-MS/MS methodology using a previously validated assay. The LLOQ for the assay was 0.25 ng/mL. AUC(0-t) was calculated by the linear-up log-down trapezoidal method. AUC(0-inf) was calculate as follows; (AUC(0-inf)) = (AUC(0-t)) + (Ct/Kel), where Ct is the last measurable drug concentration and Kel is the elimination rate constant. The apparent first-order Kel was estimated, when possible, from the slope of the regression line for the terminal ln-linear concentration-time values.|Periods 1, 2, and 3; 0 (Predose), 2, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose.|PK analysis set|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
2556497|NCT02723630|Primary|Area Under the Plasma Concentration-Time Curve From Zero Time (Predose) to Time of Last Quantifiable Concentration (AUC(0-t))|Blood samples (6 mL each) were collected at the following time points for each Period: 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose. The window for 0 to 12 hours was +/-2 minutes, for 24 hours was +/-5 minutes and for >24 hours was equal to +/-15 to 60 minutes. Plasma concentrations of lenvatinib were quantified by chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) methodology using a previously validated assay. The lower limit of quantitation (LLOQ) for the assay was 0.25 ng/mL. AUC(0-t) was calculated by the linear-up log-down trapezoidal method. No concentration estimates were provided for missing sample values. Any sample with a missing value was treated as if the sample had not been scheduled for collection.|Periods 1, 2, and 3; 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose|Pharmacokinetic (PK) analysis set included participants who had sufficient PK data to derive at least one PK parameter. Participants with a predose concentration >5% Cmax and participants who experienced emesis at or before two times median tmax were excluded from the data analysis.|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
2556498|NCT02723201|Secondary|Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose||Baseline up to Day 2|The safety analysis set included all participants who were enrolled and received 1 dose of study drug.|||participants|||Number
2556499|NCT02723201|Secondary|Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose||Baseline up to Day 2|The safety analysis set included all participants who were enrolled and received 1 dose of study drug.|||participants|||Number
2556500|NCT02723201|Secondary|Number of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post Dose||Baseline up to Day 2|The safety analysis set included all participants who were enrolled and received 1 dose of study drug.|||participants|||Number
2556501|NCT02723201|Secondary|Number of Participants Who Experience at Least One or More Treatment-emergent Adverse Event (TEAE)||Baseline up to 30 days after last dose of study drug (Day 58 in Part 1), (Day 40 in Part 2)|The safety analysis set included all participants who were enrolled and received 1 dose of study drug.|||participants|||Number
2556502|NCT02723201|Primary|Terminal Disposition Phase Half-life (T1/2z) in Plasma for TAK-020||Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|The PK set where Day 1 assessment were available. The PK set included all participants who received study drug and had at least 1 measurable plasma concentration.|||hour||Standard Deviation|Mean
2556503|NCT02723201|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-020||Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|The PK set where Day 1 assessment were available. The PK set included all participants who received study drug and had at least 1 measurable plasma concentration.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
2556504|NCT02723201|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020||Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|The PK set where Day 1 assessment were available. The PK set included all participants who received study drug and had at least 1 measurable plasma concentration.|||hour||Full Range|Median
2556505|NCT02723201|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-020||Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|The pharmacokinetic (PK) set where Day 1 assessment were available. The PK set included all participants who received study drug and had at least 1 measurable plasma concentration.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2556545|NCT02722837|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8||Week 8|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2556507|NCT02723188|Primary|Galvanic Skin Response (GSR)|"GSR was measured throughout the task using 2 standard electrodes on the fingers. Measurement units were in micro-Siemens; scores were square-root-transformed (a common method in GSR studies). A higher level of GSR in response to stimuli is taken to reflect greater physiological fear response, and thus worse in the context of the relevance of the study conditions to the treatment of anxiety disorders.~Scores were collected in response to presentation of the CS+ (the stimulus conditioned to be associated with an aversive outcome) and the CS- (the stimulus not conditioned to be associated with any outcome)."|During three-day experimental task||||micro-Siemens||Standard Deviation|Mean
2556508|NCT02723175|Primary|Post Baseline Quantitative Sensory Testing (QST)|After treatment, Quantitative Sensory Testing (QST) will be completed for all participants. The QST involves a comprehensive laboratory pain assessment including heat stimuli using a Pathway Thermo-sensory Analyzer System which is specifically designed for assessing laboratory pain testing. The QST collects the temperature in celsius of when the participant first begins to feel the stimuli (Sensory), starts to feel pain (average pain threshold), and when the participant can no longer tolerate the stimuli (Tolerance). The temperature ranges from 37 degrees celsius to 50 degrees celsius. The minimum temperature on the scale is 37 degrees celsius and the maximum temperature on the scale is 50 degrees celsius. Average pain threshold: A lower temperature represents a lower pain threshold and a higher temperature represents a higher pain threshold. Tolerance: A lower temperature represents a lower pain tolerance and a higher temperature represents a higher pain tolerance.|One week Post Treatment||||Degrees Celsius||Standard Deviation|Mean
2556509|NCT02723175|Secondary|The Fibromyalgia (FM) Impact Questionnaire at 1 Month Follow Up|To assess the impact of fibromyalgia on each participant's function at the 1 Month Follow Up visit, The Fibromyalgia (FM) Impact Questionnaire will be administered. The FM assesses the following symptoms; physical Impairment, well-being, pain, fatigue, rested, stiffness, anxiety, and depression within the past 24 hours. Each symptom scale ranges from 0 to 10. For example, 0=no pain and 10=extreme pain, 0=not fatigued and 10=extremely fatigued. The final score is the total score which ranges from 0 to 80. Higher scores indicate greater impact of fibromyalgia on functioning.|1 Month Follow Up||||units on a scale||Standard Deviation|Mean
2556510|NCT02723175|Secondary|The Short-Form 12 Healthy Survey at 1 Month Follow Up|To assess each participant's mental and physical functioning at the 1 Month Follow Up visit, The Short-Form 12 Healthy Survey (SF-12) will be administered. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey (Ware, Kosinski, and Keller, 1996). The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|1 Month Follow Up||||units on a scale||Standard Deviation|Mean
2556511|NCT02723175|Secondary|Affective Subscale of McGill Pain Questionnaire at 1 Month Follow Up|Participants completed the McGill Pain Questionnaire-short form (MPQ) at Baseline. The possible total range of scores is 0 to 45. The MPQ has two pain dimensions: 1.Sensory subscale with 11 words, and 2.Affective subscale with 4 words from the original MPQ. The range of scores for the sensory dimension of pain is 0-33. The data below report the mean score for the affective subscale of the McGill Pain Questionnaire for both groups. The range of scores for the affective subscale being 0-12 with Higher scores indicating worse pain.|1 Month Follow Up|"3 Sham tDCS Participants dropped out leaving 5 total participants in Sham group.~2 Anodal tDCS Participants dropped out leaving 5 total participants in Anodal group."|||units on a scale||Standard Deviation|Mean
2556512|NCT02723175|Secondary|Percent Change in Average Daily Pain at 3 Month Follow Up|Participants were asked to rate their pain on average every day for 60 days, post 1 month follow up visit. Average pain ratings were on 0-10 scale. 0=No Pain at all and 10=Extreme Pain. The 3 Month Follow Up included 60 Daily Pain ratings (Collected Post 1 Month Follow Up) that were averaged. The change in average daily pain ratings from the 1 month follow up (30 days post completion of treatment visit 6) to the 3 Month Follow Up (60 days post completion of the 1 month follow up visit) was calculated below. Time points 1 month follow up, and 3 month follow up were included to calculate percent change.|3 Month Follow Up||||percent change||Standard Deviation|Mean
2556513|NCT02723175|Secondary|Percent Change in Average Daily Pain at 1 Month Follow Up|Participants were asked to rate their pain on average every day 30 days post treatment 6 (1 month follow up). Average pain ratings were on 0-10 scale. 0=No Pain at all and 10=Extreme Pain. The 30 Daily ratings (Post Treatment 6) were averaged and The change in average daily pain ratings from treatment 6 to the 1 month follow up (30 days post completion of treatment visit 6) was calculated below. Time points week 6, and the 1 month follow up were included to calculate percent change.|1 Month Follow Up||||percent change||Standard Deviation|Mean
2556514|NCT02723175|Secondary|Percent Change in Average Daily Pain at Treatment Visit Six|Participants were asked to rate their pain on average every day from the start of Treatment 3 until Treatment 6. Average pain ratings were on 0-10 scale. 0=No Pain at all and 10=Extreme Pain. Daily ratings were averaged at treatment 3 and treatment 6. The change in average daily pain ratings from treatment 3 to treatment 6 was calculated below. Time points at week 3, and week 6 were included to calculate percent change.|Treatment Session 6 (week 6)||||percent change||Standard Deviation|Mean
2556515|NCT02723175|Secondary|Brief Pain Inventory-Average Pain at 1 Month Follow Up|At the one month follow up visit, The Brief Pain Inventory (BPI)-short form will be administered to assess each participant's pain on average in the past 30 days. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their pain on average in the past 30 days using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.|1 Month Follow Up||||units on a scale||Standard Deviation|Mean
2556516|NCT02723175|Secondary|The Beck Anxiety Inventory (BAI) at 3 Month Follow Up|The Beck Anxiety Inventory (BAI) is a well-researched, brief self-report anxiety-screening instrument that assesses different aspects of anxiety experience (e.g., physiological, cognitive, behavioral). It was designed to measure participant's level of anxiety. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety.|3 Month Follow Up||||units on a scale||Standard Deviation|Mean
2556546|NCT02722837|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4||Week 4|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2556517|NCT02723175|Secondary|The Beck Depression Inventory (BDI) at 1 Month Follow up|The Beck Depression Inventory (BDI) will be used for screening purposes to characterize depression in each participant at the one month follow up visit. The BDI is a 21 item participant rated inventory that evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. The BDI scale also assesses suicidal ideation, those patients exhibiting suicidal ideations will be referenced to a therapist in order to further manage their depressive symptoms. The Total score range is 0 to 63; higher score indicates more depression. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe.|1 month follow up||||units on a scale||Standard Deviation|Mean
2556518|NCT02723175|Secondary|The Fibromyalgia (FM) Impact Questionnaire at Baseline|To assess the impact of fibromyalgia on each participant's function at baseline, The Fibromyalgia (FM) Impact Questionnaire will be administered. The FM assesses the following symptoms; physical Impairment, well-being, pain, fatigue, rested, stiffness, anxiety, and depression within the past 24 hours. Each symptom scale ranges from 0 to 10. For example, 0=no pain and 10=extreme pain, 0=not fatigued and 10=extremely fatigued. The final score is the total score which ranges from 0 to 80. Higher scores indicate greater impact of fibromyalgia on functioning.|Before Treatment||||units on a scale||Standard Deviation|Mean
2556519|NCT02723175|Secondary|The Short-Form 12 Healthy Survey at Baseline|To assess each participant's mental and physical functioning at Baseline, The Short-Form 12 Healthy Survey (SF-12) will be administered. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey (Ware, Kosinski, and Keller, 1996). The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.|Before Treatment||||units on a scale||Standard Deviation|Mean
2556520|NCT02723175|Secondary|Affective Subscale of McGill Pain Questionnaire at Baseline|Participants completed the McGill Pain Questionnaire-short form (MPQ) at Baseline. The possible total range of scores (Sensory and Affective subscales together) is 0 to 45. The MPQ has two pain dimensions: 1.Sensory subscale awith 11 words, and 2.Affective subscale with 4 words from the original MPQ. The range of scores for the sensory dimension of pain is 0-33. The data below report the mean score for the affective subscale for both groups. The range of scores for the affective subscale being 0-12 with Higher scores indicating worse pain.|Before Treatment||||units on a scale||Standard Deviation|Mean
2556521|NCT02723175|Secondary|Percent Change in Average Daily Pain at Treatment Visit 3|Participants were asked to rate their pain on average every day from the start of Treatment 1 until Treatment 3. Average pain ratings were on 0-10 scale. 0=No Pain at all and 10=Extreme Pain. Daily ratings were averaged at treatment 1 and treatment 3. The change in average daily pain ratings from treatment 1 to treatment 3 was calculated below. Time points at week 1 and week 3 were included to calculate percent change.|Treatment Session 3 (week 3)||||percent change||Standard Deviation|Mean
2556522|NCT02723175|Secondary|Brief Pain Inventory-Average Pain at Baseline|To assess each participant's average pain at baseline, the Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.|Before Treatment||||units on a scale||Standard Deviation|Mean
2556523|NCT02723175|Secondary|The Beck Anxiety Inventory (BAI) at Baseline|The Beck Anxiety Inventory (BAI) is a well-researched, brief self-report anxiety-screening instrument that assesses different aspects of anxiety experience (e.g., physiological, cognitive, behavioral). It was designed to measure participant's level of anxiety. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety.|Before Treatment||||units on a scale||Standard Deviation|Mean
2556524|NCT02723175|Secondary|The Beck Depression Inventory (BDI) at Baseline|The Beck Depression Inventory (BDI) will be used for screening purposes to characterize depression in each participant at baseline. The BDI is a 21 item participant rated inventory that evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. The BDI scale also assesses suicidal ideation, those patients exhibiting suicidal ideations will be referenced to a therapist in order to further manage their depressive symptoms. The Total score range is 0 to 63; higher score indicates more depression. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe.|Before Treatment||||units on a scale||Standard Deviation|Mean
2556525|NCT02723175|Primary|Baseline Quantitative Sensory Testing (QST)|Before treatment, Quantitative Sensory Testing (QST) will be completed for all participants. The QST involves a comprehensive laboratory pain assessment including heat stimuli using a Pathway Thermo-sensory Analyzer System which is specifically designed for assessing laboratory pain testing. The QST collects the temperature in celsius of when the participant first begins to feel the stimuli (Sensory), starts to feel pain (average pain threshold), and when the participant can no longer tolerate the stimuli (Tolerance). The temperature ranges from 37 degrees celsius to 50 degrees celsius. The minimum temperature on the scale is 37 degrees celsius and the maximum temperature on the scale is 50 degrees celsius. Average pain threshold: A lower temperature represents a lower pain threshold and a higher temperature represents a higher pain threshold. Tolerance: A lower temperature represents a lower pain tolerance and a higher temperature represents a higher pain tolerance.|Before Treatment||||Degrees Celsius||Standard Deviation|Mean
2556526|NCT02723084|Secondary|Percentage of Participants With Post-Treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding participants who were been shown to be re-infected. 95% CI was calculated using the Wilson score method.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
2556547|NCT02722837|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2||Week 2|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2556548|NCT02722837|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 1||Week 1|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2556527|NCT02723084|Secondary|Percentage of Participants With With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. 95% CI was calculated using the Wilson score method.|Treatment Weeks 1, 2, 4, 8 (end of treatment for arm A), and 12 (end of treatment for arm B) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
2556528|NCT02723084|Secondary|Percentage of Participants in Arm A With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2556529|NCT02723084|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Non-inferiority of Arm A to Arm B|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. The primary efficacy endpoint was non-inferiority of the ABT-493/ABT-530 8-week regimen (Arm A) to the sofosbuvir and ribavirin 12 week regimen (Arm B) in SVR12 using a non-inferiority margin of 10% in the intent-to-treat (ITT) population.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants|||Number
2556530|NCT02722967|Primary|Assessment of the Functionality of an Integrated Call Center for DMS by Adult Subjects With SCH, MDD, or BP1 Who Were Treated With Oral Aripiprazole.|"The primary outcome was assessed as the establishment of a functional and operational integrated call center with coordinated feedback to the subject and investigative site to optimize the use of DMS as measured by:~Inbound calls (ie, calls from the subject to the integrated call center) by help type;~Outbound calls (ie, calls from the integrated call center to the subject) by help type.~The number presented in the table is the number of subjects in trial who made (inbound) or received (outbound) calls"|From baseline upto week 9|Intent-to-treat (ITT) Sample: All subjects who entered the trial and used Digital Medicine System (DMS).|||participants|||Number
2556531|NCT02722928|Secondary|Changes in Neurological Outcomes at POD 3 Compared to Preoperative Evaluation|"Changes in Neurological Outcomes from baseline (preoperative evaluation) were documented based on differences (if any) found between both physical examinations: baseline (before surgery) and postoperative day (POD) 3 neurological exam. Results were reported as improvement (partial or total recovery of baseline neurological signs/symptoms), no changes, and deterioration (focal or global neurological deterioration) in comparison with baseline neurological examination"|preoperative to postoperative day 3||||Participants|||Count of Participants
2556532|NCT02722928|Secondary|Pneumocephalus Volume and Posterior Fossa Surgery|Pneumocephalus volume in patients who underwent posterior fossa surgery|one to six hours after surgery||||cm^3||Inter-Quartile Range|Median
2556533|NCT02722928|Secondary|Pneumocephalus Volume and Anterior Fossa Surgery|To compare the presence of postoperative pneumocephalus in patients who underwent anterior fossa surgery.|One to six hours after surgery||||cm^3||Inter-Quartile Range|Median
2556534|NCT02722928|Primary|Occurrence of Postoperative Pneumocephalus|Compare the occurrence rate of postoperative pneumocephalus (present or not present) in patients receiving intraoperative ventilation with 100% oxygen during hemostasis and wound closure versus 1:1 oxygen / air mixture|One to six hours after surgery||||Participants|||Count of Participants
2556535|NCT02722928|Primary|Volume of Postoperative Pneumocephalus|Compare the extent (cm3) of postoperative pneumocephalus in patients ventilated intraoperatively with 100% oxygen during hemostasis and wound closure versus 1:1 oxygen / air mixture|One to six hours after surgery||||cm^3||Inter-Quartile Range|Median
2556536|NCT02722863|Secondary|Change of the Serum Sodium Level(mEq/L) at the First Visit and Day 4 After the First Visit|In the efficacy analysis set, mean change of serum sodium level (mEq/L)on the 4th day compared to the first visit|Follow-up at least 4 days after first Samsca® dose|the efficacy set is patients who received Samsca® tablets for at least 4 consecutive days and had the data on serum sodium level(mEq/L) on the 4th day of receiving Samsca® tablets.|||mean change of serum sodium level(mEq/L)||Standard Deviation|Mean
2556537|NCT02722863|Primary|Safety Measure|Adverse Events (AEs)|4days|Safety analysis set was defined as all patients who received Samsca® tablets at least once and had at least one post-treatment assessment during the study in approved indication and dosage regimen.|||percentage of AE||95% Confidence Interval|Number
2556538|NCT02722837|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or~Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2556539|NCT02722837|Secondary|Change From Baseline in HCV RNA at Week 12||Baseline (Day 1); Week 12|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
2556540|NCT02722837|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline (Day 1); Week 8|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
2556541|NCT02722837|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline (Day 1); Week 4|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
2556542|NCT02722837|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline (Day 1); Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2556543|NCT02722837|Secondary|Change From Baseline in HCV RNA at Week 1||Baseline (Day 1); Week 1|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2556544|NCT02722837|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12||Week 12|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2556561|NCT02722330|Secondary|Free Field - Speech Recognition in Quiet, Investigational Device vs Softband|Change of hearing performance free field - speech recognition in quiet from the situation with the same sound processor on a Baha Softband with the Investigational device on the attract system at 4 weeks|4 weeks||||Percentage (%) correct words||Standard Deviation|Mean
2556562|NCT02722330|Secondary|Free Field - Adaptive Speech Recognition in Noise, Investigational Device vs Softband|Change of hearing performance free field - adaptive speech recognition in noise from the situation with the same sound processor on a Baha softband at pre-operation with the Investigational device on the attract system at 12 weeks|12 weeks||||dB||Standard Deviation|Mean
2556563|NCT02722330|Secondary|Free Field - Adaptive Speech Recognition in Noise, Investigational Device vs Softband|Change of hearing performance free field - adaptive speech recognition in noise from the situation with the same sound processor on a Baha softband at pre-operation with the Investigational device on the attract system at 4 weeks|4 weeks||||dB||Standard Deviation|Mean
2556564|NCT02722330|Secondary|Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband|Change of hearing performance free field tresholds per frequency [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz] from the same sound processor on a Baha softband with the Investigational device on the attract system at 12 weeks|12 weeks||||dB HL||Standard Deviation|Mean
2556565|NCT02722330|Secondary|Audiometry; Free Field Thresholds Per Frequency, Investigational Device vs Softband|Change of hearing performance free field tresholds per frequency [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz] from the situation with same sound processor on a Baha softband with the Investigational device on the attract system at 4 weeks|4 weeks||||dB HL||Standard Deviation|Mean
2556566|NCT02722330|Secondary|Audiometry; Free Field Thresholds. Pure Tone Average PTA4 [Mean of 0.5, 1, 2 and 4 kHz], Investigational Device vs Softband|Change of hearing performance PTA4 from the situation with the same sound processor on a Baha soft band at pre-operation with the Investigational device on the attract system at 12 weeks|12 weeks||||dB HL||Standard Deviation|Mean
2556567|NCT02722330|Secondary|Audiometry; Free Field Thresholds. Pure Tone Average PTA4, Investigational Device vs Softband|Change of hearing performance PTA4 [Mean of 0.5, 1, 2 and 4 kHz] from the situation with the same sound processor on a Baha soft band at pre-operation with the Investigational device on the attract system at 4 weeks|4 weeks||||dB HL||Standard Deviation|Mean
2556568|NCT02722330|Secondary|Free Field; - Speech Recognition in Quiet, Unaided vs Aided|Change of hearing performance free field - speech recognition in quiet from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks|12 weeks||||Percentage (%) correct words||Standard Deviation|Mean
2556569|NCT02722330|Secondary|Free Field; - Speech Recognition in Quiet, Unaided vs Aided|Change of hearing performance free field - speech recognition in quiet from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks|4 weeks||||Percentage (%) correct words||Standard Deviation|Mean
2556570|NCT02722330|Secondary|Free Field; - Adaptive Speech Recognition in Noise, Unaided vs Aided|Change of hearing performance free field - adaptive speech recognition in noise from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks|12 weeks||||dB||Standard Deviation|Mean
2556571|NCT02722330|Secondary|Free Field; - Adaptive Speech Recognition in Noise, Unaided vs Aided|Change of hearing performance free field - adaptive speech recognition in noise from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks|4 weeks||||dB||Standard Deviation|Mean
2556572|NCT02722330|Secondary|Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided|Change of hearing performance free field tresholds per frequency [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz] from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks|12 weeks||||dB HL||Standard Deviation|Mean
2556573|NCT02722330|Secondary|Audiometry; Free Field Thresholds Per Frequency, Unaided vs Aided|Change of hearing performance free field tresholds per frequency [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 kHz] from unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks|4 weeks||||dB HL||Standard Deviation|Mean
2556574|NCT02722330|Secondary|Audiometry; Free Field Thresholds. Pure Tone Average PTA4 Unaided vs Aided|Change of hearing performance PTA4 [Mean of 0.5, 1, 2 and 4 kHz] from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 4 weeks|4 weeks||||dB HL||Standard Deviation|Mean
2556575|NCT02722330|Secondary|Change of the Self-reported Assessments of Hearing Outcome Using Speech, Spatial and Qualities of Hearing Scale (SSQ-12) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, Aided at 12 Weeks.|"The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item.~The change from unaided to aided hearing is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing."|12 weeks||||score on a scale||Standard Deviation|Mean
2556576|NCT02722330|Secondary|Change of the Self-reported Assessments of Hearing Outcome Using Abbreviated Profile of Hearing Aid Benefit (APHAB) From the Unaided Hearing Situation at Pre-operation With the Investigational Device on the Attract System, at 12 Weeks.|"The APHAB is a 24-item self-assessment questionnaire evaluating the benefit experienced by the subject when using hearing amplification compared to the unaided situation. It comprises of four subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV). The Global score is the mean of the subscales. All subscales are scored in the same way.~The scores show how frequently (%) clients experience performance problems and varies between 0-100, 0 indicates no problems, 100 indicates always problem. Benefit is then calculated by subtracting the aided average from the unaided average. The theoretical benefit score could vary between -100 to + 100. The higher the score the better benefit and positive score indicates an improvement, a negative value an impairment."|12 weeks||||score on a scale||Standard Deviation|Mean
2556577|NCT02722330|Primary|Audiometry; Free Field Thresholds. Pure Tone Average PTA4,Unaided vs Aided|Change of hearing performance PTA4 [Mean of 0.5, 1, 2 and 4 kHz] from the unaided hearing situation at pre-operation with the Investigational device on the attract system, aided at 12 weeks|12 weeks||||dB HL||Standard Deviation|Mean
2556578|NCT02722304|Secondary|Number of Participants Who Developed Anti-A1PI Antibodies Following Treatment With ARALAST NP or GLASSIA|Number of participants who developed anti- A1PI antibodies following treatment with ARALAST NP or GLASSIA were reported. Anti-A1PI binding antibody were determined for the samples that tested positive or negative at each assessment time point.|Baseline, Early termination of the study (approximately 22 months)|SAS included all participants who had received any amount of IP or placebo, regardless of protocol deviations or non-adherence to the study procedures. Analysis was performed according to the treatment regimen received regardless of the randomized treatment regimen.|||Participants|||Count of Participants
2556579|NCT02722304|Secondary|Percentage of Participants With at Least One Infusion Rate Change or Infusion Interruption or Stopped Due to AEs|An Adverse event (AE) was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. Number of infusions for which the infusion rate was reduced and/or the infusion interrupted or stopped due to adverse events (AEs) were reported.|From start of study treatment up to early termination of the study (approximately 22 months)|SAS included all participants who had received any amount of IP or placebo, regardless of protocol deviations or non-adherence to the study procedures. Analysis was performed according to the treatment regimen received regardless of the randomized treatment regimen.|||Percentage of Participants|||Number
2556580|NCT02722304|Secondary|Percentage of Participants With Suspected Adverse Reactions or Serious and Non-Serious Adverse Reactions (ARs)|An Adverse Reactions (AR) plus suspected adverse reaction is any adverse event which met any of the following criteria: an adverse event that began during infusion or within 72 hours following the end of IP infusion; an adverse event considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration; an adverse event for which causality assessment was missing or indeterminate. Adverse reaction included both serious and non-serious ARs.|From start of study treatment up to early termination of the study (approximately 22 months)|SAS included all participants who had received any amount of IP or placebo, regardless of protocol deviations or non-adherence to the study procedures. Analysis was performed according to the treatment regimen received regardless of the randomized treatment regimen.|||Percentage of Participants|||Number
2556581|NCT02722304|Secondary|Number of Events With Suspected Adverse Reactions or Serious and Non-Serious Adverse Reactions (ARs)|An Adverse Reactions (ARs) plus suspected adverse reaction is any adverse event which met any of the following criteria: an adverse event that began during infusion or within 72 hours following the end of IP infusion; an adverse event considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration; an adverse event for which causality assessment was missing or indeterminate. Adverse reaction included both serious and non-serious ARs.|From start of study treatment up to early termination of the study (approximately 22 months)|SAS included all participants who had received any amount of investigational product (IP) or placebo, regardless of protocol deviations or non-adherence to the study procedures. Analysis was performed according to the treatment regimen received regardless of the randomized treatment regimen.|||Events|||Number
2556582|NCT02722304|Secondary|Percentage of Participants With Temporally Related Serious and Non-Serious Treatment Emergent Adverse Events (AEs)|An Adverse event (AE) was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose. A non-serious AE is an AE that does not meet the criteria of an SAE. TEAEs were temporally related to treatment administration (ie, occurred within 72 hours following the end of the infusion). TEAE Related to IP were considered.|From start of study treatment up to early termination of the study (approximately 22 months)|SAS included all participants who had received any amount of IP or placebo, regardless of protocol deviations or non-adherence to the study procedures. Analysis was performed according to the treatment regimen received regardless of the randomized treatment regimen.|||Percentage of Participants|||Number
2556583|NCT02722304|Secondary|Number of Events With Temporally Related Serious and Non-Serious Treatment Emergent Adverse Events (AEs)|An Adverse event (AE) was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose. A non-serious AE is an AE that does not meet the criteria of an SAE. TEAEs were temporally related to treatment administration (ie, occurred within 72 hours following the end of the infusion). TEAE Related to IP were considered.|From start of study treatment up to early termination of the study (approximately 22 months)|SAS included all participants who had received any amount of IP or placebo, regardless of protocol deviations or non-adherence to the study procedures. Analysis was performed according to the treatment regimen received regardless of the ( randomized treatment regimen.|||Events|||Number
2556594|NCT02722239|Primary|"Area Under the Concentration - Time Curve (AUC0-t)"||Blood sampling 0 h, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the dosing. Time interval for sampling is provided with pharmacokinetic characteristics of the product.||||ug/mL*h||Standard Deviation|Mean
2556595|NCT02722239|Primary|Maximum Concentration (Cmax).||Blood sampling 0 h, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the dosing. Time interval for sampling is provided with pharmacokinetic characteristics of the product.||||ug/ml||Standard Deviation|Mean
2556584|NCT02722304|Secondary|Percentage of Participants With Related and Unrelated Serious and Non-Serious Treatment Emergent Adverse Events (TEAE's)|An Adverse event (AE) was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose. A non-serious AE is an AE that does not meet the criteria of an SAE. TEAE related to IP and Study Procedures were considered. Percentage of participants with related and unrelated serious and non-serious TEAE were reported.|From start of study treatment up to early termination of the study (approximately 22 months)|SAS included all participants who had received any amount of IP or placebo, regardless of protocol deviations or non-adherence to the study procedures. Analysis was performed according to the treatment regimen received regardless of the randomized treatment regimen.|||Percentage of Participants|||Number
2556585|NCT02722304|Secondary|Number of Events With Related and Unrelated Serious and Non-Serious Treatment Emergent Adverse Event (TEAE)|An Adverse event (AE) was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose. TEAE related to Investigational Product (IP) and Study Procedures (SP) were considered. A non-serious AE is an AE that does not meet the criteria of an SAE. Number of events with related and unrelated serious and non-serious TEAE were reported.|From start of study treatment up to early termination of the study (approximately 22 months)|SAS included all participants who had received any amount of IP or placebo, regardless of protocol deviations or non-adherence to the study procedures. Analysis was performed according to the treatment regimen received regardless of the randomized treatment regimen.|||Events|||Number
2556586|NCT02722304|Secondary|Mean Steady State Trough Concentration of Antigenic and Functional Alpha1-Proteinase Inhibitor (A1PI) for ARALAST NP and GLASSIA at Each Dose Level|Mean steady state trough concentration of antigenic and functional alpha1-proteinase inhibitor (a1pi) for ARALAST NP and GLASSIA at each dose level was reported.|Baseline, Early termination of the study (approximately 22 months)|Study was early terminated due to low and slow rate of enrollment, hence, data was not collected for this efficacy endpoint.||||||
2556587|NCT02722304|Secondary|Rate of Change in Lung Density for Each Treatment Group|Rate of change in lung density was assessed by computed tomography (CT) densitometry for each treatment group. Computed Tomography (CT) scans was used to measure lung density as a quantitative assessment of emphysema progression and treatment efficacy at each of the study visits. The safety analysis set used for all the efficacy parameter assessment.|Baseline, Early termination of the study (approximately 22 months)|Study was early terminated due to low and slow rate of enrollment, hence, data was not collected for this efficacy endpoint.||||||
2556588|NCT02722304|Primary|Rate of Change in Lung Density Based on Group 1 (ARALAST NP) Versus Placebo, Group 3 and Group 4 (GLASSIA) Versus Placebo|Rate of change in lung density was assessed by computed tomography (CT) densitometry. Computed Tomography (CT) scans was used to measure lung density as a quantitative assessment of emphysema progression and treatment efficacy at each of the study visits. CT lung density at the 15th percentile (PD15) is the threshold below which 15% of the voxels have lower densities, and was used as the parameter for estimating the rate of lung density decline. Rate of change in lung density based on Group 1 (ARALAST NP) versus Placebo, Group 3 and Group 4 (GLASSIA) versus Placebo were reported. The safety analysis set used for all the efficacy parameter assessment.|Baseline, Early termination of the study (approximately 22 months)|Study was early terminated due to low and slow rate of enrollment, hence, data was not collected for this efficacy endpoint.||||||
2556589|NCT02722278|Other Pre-specified|Number of Participants With Post-stimulation Cortisol Level of >18 ug/dL at Visit 8|Compare the Oral TU-treated subjects and the Topical Axiron®-treated subjects with respect to number of subjects in the cosyntropin stimulation test substudy with a normal maximum post-stimulation (cosyntropin stimulation) cortisol level at Visit 8.|Approximately 4.5 months||||Participants|||Count of Participants
2556590|NCT02722278|Primary|Number of Oral TU Treated Subjects Who Have a Total T Cavg in the Eugonadal Range of 252 to 907 ng/dL at Visit 7||Day 105|Intent-to-treat study population All subjects randomized to either Oral TU or Axiron|||Participants|||Count of Participants
2556591|NCT02722239|Primary|Adverse Events|Adverse events data for Dapagliflozin + Metformin, modified-release film-coated tablets, 10 mg + 1000 mg (AstraZeneca AB, Sweden) and for co-administered Forxiga™ (Dapagliflozin), film-coated tablets, 10 mg, (Bristol Myers Squibb Company, USA) and Glucophage® long (Metformin), XR tablets, 500 mg/2 tablets (Merck Santé S.A.S, France)|AE information will be collected from the time of the first dosing to the last study procedure made in the hospital, approximately 1 month||||adverse event|||Number
2556592|NCT02722239|Primary|Bioequivalence Consideration: 90% Confidence Intervals for the Test:Reference Geometric Least Squares Mean Ratios|The drugs are considered bioequivalent if the 90% confidence intervals for the Test : Reference products geometric least squares mean ratios of AUC, Cmax и Cmax/AUC parameters are in the range of 80% - 125%.|Blood sampling 0 h, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the dosing. Time interval for sampling is provided with pharmacokinetic characteristics of the product.|The Arms/Groups are combined because the main study goal was to compare the bioequivalence of the study drug and the reference drug which were intaken by all volunteers regardless of the group.|||Geometric least squares mean ratio (%)||90% Confidence Interval|Least Squares Mean
2556593|NCT02722239|Primary|"Area Under the Concentration - Time Curve (AUC0-∞)"||Blood sampling 0 h, 30 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours and 72 hours after the dosing. Time interval for sampling is provided with pharmacokinetic characteristics of the product.||||ug/mL*h||Standard Deviation|Mean
2556596|NCT02722148|Secondary|Dysphagia Symptom Score|Post treatment symptoms, as measured by a validated dysphagia symptom score, the EoE Symptom Activity Index (EEsAI). This score ranges from 0-100, with higher scores indicating more severe symptoms. A score of < 20 indicates clinical remission.|6 Weeks||||score on a scale||Standard Deviation|Mean
2556597|NCT02722148|Secondary|Endoscopy Score|Post treatment endoscopic appearance, as measured by a validated endoscopy score - the EoE Endoscopic Reference Score (EREFS). This score measures endoscopic severity with a set of five endoscopic findings (exudates, rings, edema, furrows, and strictures), and ranges from 0-9, with higher scores indicating higher endoscopic severity.|6 Weeks||||units on a scale||Standard Deviation|Mean
2556598|NCT02722148|Secondary|Median Peak Esophageal Eosinophil Count|Eosinophil count per High Power Field|6 Weeks||||eosinophils per high power field||Inter-Quartile Range|Median
2556599|NCT02722148|Primary|Percentage of Histologic Responders|The primary outcome will be histologic response, defined as a post-treatment esophageal eosinophil count of <15 eos/hpf.|6 Weeks|Data reported only for compliant participants|||percentage of participants|||Number
2556600|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With nADAs at the Safety Follow-Up Visit|A participant was considered to have developed nADAs if a confirmed positive result was observed at any time during the treatment period post-dose. Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Safety Follow-Up Visit (32 Weeks)|Safety Analysis Set. Only those participants contributing data at Week 32 were analyzed.|||Participants|||Count of Participants
2556601|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 24|A participant was considered to have developed nADAs if a confirmed positive result was observed at any time during the treatment period post-dose. Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Week 24|Safety Analysis Set. Only those participants contributing data at Week 24 were analyzed.|||Participants|||Count of Participants
2556602|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 12|A participant was considered to have developed nADAs if a confirmed positive result was observed at any time during the treatment period post-dose. Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Week 12|Safety Analysis Set. Only those participants contributing data at Week 12 were analyzed.|||Participants|||Count of Participants
2556603|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With nADAs at Week 4|A participant was considered to have developed nADAs if a confirmed positive result was observed at any time during the treatment period post-dose. Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Week 4|Safety Analysis Set. Only those participants contributing data at Week 4 were analyzed.|||Participants|||Count of Participants
2556604|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With Neutralizing Anti-drug Antibodies (nADAs) at Baseline|A participant was considered to have developed nADAs if a confirmed positive result was observed at any time during the treatment period post-dose. Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Baseline (Day 1)|Safety Analysis Set|||Participants|||Count of Participants
2556605|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at the Safety Follow-Up Visit|A participant was considered to have developed ADAs if a confirmed positive result was observed at any time during the treatment period post-dose (irrespective of titer value). Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Safety Follow-Up Visit (32 Weeks)|Safety Analysis Set. Only those participants contributing data at Week 32 were analyzed.|||Participants|||Count of Participants
2556606|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 24|A participant was considered to have developed ADAs if a confirmed positive result was observed at any time during the treatment period post-dose (irrespective of titer value). Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Week 24|Safety Analysis Set. Only those participants contributing data at Week 24 were analyzed.|||Participants|||Count of Participants
2556607|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 12|A participant was considered to have developed ADAs if a confirmed positive result was observed at any time during the treatment period post-dose (irrespective of titer value). Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Week 12|Safety Analysis Set. Only those participants contributing data at Week 12 were analyzed.|||Participants|||Count of Participants
2556608|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of ADAs at Week 4|A participant was considered to have developed ADAs if a confirmed positive result was observed at any time during the treatment period post-dose (irrespective of titer value). Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Week 4|Safety Analysis Set. Only those participants contributing data at Week 4 were analyzed.|||Participants|||Count of Participants
2556609|NCT02722044|Secondary|Immunogenicity of M923 Assessed as the Number of Participants With Evidence of Seroconversion as Measured by Titer of Anti-drug Antibodies (ADAs) at Baseline|A participant was considered to have developed ADAs if a confirmed positive result was observed at any time during the treatment period post-dose (irrespective of titer value). Samples were collected predose (prior to administering investigational product) and before any hematology/chemistry samples were drawn at that visit.|Baseline (Day 1)|Safety Analysis Set|||Participants|||Count of Participants
2556925|NCT02718118|Secondary|Proportion of Responders, at Maximum Frown (Subject)|Proportion of responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments by subject using a static 4-point categorical (subject) scale.|120 days||||Participants|||Count of Participants
2556610|NCT02722044|Secondary|Number of Participants With Treatment-emergent Injection Site Reactions|An injection site reaction is defined as pain, tenderness, erythema/redness, induration/swelling, and other. If an injection site reaction was observed, a physician was to characterize and document the reaction as an adverse event (AE). Treatment-emergent adverse events (TEAEs) are defined as AEs that started or worsened in severity on or after the first dose of study medication, until study completion/withdrawal or within 30 days following the last treatment for early withdrawn participants.|32 Weeks|Safety Analysis Set|||Participants|||Count of Participants
2556611|NCT02722044|Secondary|Number of Participants With Adverse Events Leading to Premature Study Withdrawal|The number of participants who had an adverse event that led to premature study withdrawal was assessed.|32 Weeks|Safety Analysis Set|||Participants|||Count of Participants
2556612|NCT02722044|Secondary|Number of Participants With Clinically Significant Changes in Twelve-lead Electrocardiogram (ECG) Findings|Clinical significance was assessed by the Investigator.|Baseline; 32 Weeks|Safety Analysis Set|||Participants|||Count of Participants
2556613|NCT02722044|Secondary|Number of Participants With Vital Signs Outside the Expected Range|Vital signs included respiratory rate, body temperature, pulse rate, and systolic and diastolic blood pressure.|32 Weeks|Safety Analysis Set|||Participants|||Count of Participants
2556614|NCT02722044|Secondary|Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments|Hematology, clinical chemistry, and urinalysis clinical laboratory parameters were assessed. The hematology panel consisted of complete blood count, hemoglobin, hematocrit, mean cell volume, total leukocytes, and platelet counts. The clinical chemistry panel consisted of aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase, total bilirubin, lactate dehydrogenase, creatine kinase, C-reactive protein, cholesterol, triglycerides, total protein, sodium, potassium, chloride, blood urea nitrogen, creatinine, albumin, calcium, phosphate, glucose, glycosylated hemoglobin, uric acid, and bicarbonate. The urinalysis panel consisted of leucocytes, protein, bilirubin, urobilinogen, glucose, ketones, blood pH, nitrite, and specific gravity. Clinical significance was assessed by the Investigator.|Baseline; 32 Weeks|Safety Analysis Set: all participants who received study medication|||Participants|||Count of Participants
2556615|NCT02722044|Secondary|Number of Participants With Hazard-free Injections as Assessed by the Observer at Week 2|"Observers assessed usability by using a potential hazard checklist. If all potential hazards in the checklist were checked as no, the assessment was coded as hazard free."|Week 2|Usability Analysis Set|||Participants|||Count of Participants
2556616|NCT02722044|Secondary|Number of Participants With Successful Injections as Assessed by the Observer at Week 2|"Observers assessed usability by using a self-injection checklist. Self-injection assessment was coded as successful if categories P7 (removed protective needle cap from auto-injector), P10 (press down on auto-injector to insert the needle into the skin), and P11 (held auto-injector pressed fully down through second click sound) were checked as yes."|Week 2|Usability Analysis Set|||Participants|||Count of Participants
2556617|NCT02722044|Secondary|Number of Participants With Hazard-free Injections as Assessed by the Observer at Baseline|"Observers assessed usability by using a potential hazard checklist. If all potential hazards in the checklist were checked as no, the assessment was coded as hazard free."|Baseline (Day 1)|Usability Analysis Set|||Participants|||Count of Participants
2556618|NCT02722044|Secondary|Number of Participants With Successful Injections as Assessed by the Observer at Baseline|"Observers assessed usability by using a self-injection checklist. Self-injection assessment was coded as successful if categories P7 (removed protective needle cap from auto-injector), P10 (press down on auto-injector to insert the needle into the skin), and P11 (held auto-injector pressed fully down through second click sound) were checked as yes."|Baseline (Day 1)|Usability Analysis Set|||Participants|||Count of Participants
2556619|NCT02722044|Secondary|Usability of the Auto-injector at Week 2|The usability measure was the participant rating captured in the PRE- and POST- SIAQ modules at Week 2. The PRE-SIAQ module is a 7-item questionnaire that investigates feelings about injections, self-confidence (regarding self-administration), and satisfaction with self-injection. The POST-SIAQ module is a 27-item questionnaire that assesses feelings about injections, self-image, self-confidence (regarding self-administration), pain and skin reactions during or after injection (injection-site reactions), ease of use of the self-injection device, and satisfaction with self-injection. Participants rated each item of the SIAQ on a 5-point (or 6-point) semantic Likert-type scale, where a score of 1 corresponds to a participant's worst experience and a score of 5 (or 6) corresponds to a participant's best experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item.|Week 2|Usability Analysis Set|||Scores on a scale||Standard Deviation|Mean
2556620|NCT02722044|Secondary|Usability of the Auto-injector at Baseline|The usability measure was the participant rating captured in the PRE- and POST- SIAQ modules at Baseline. The PRE-SIAQ module is a 7-item questionnaire that investigates feelings about injections, self-confidence (regarding self-administration), and satisfaction with self-injection. The POST-SIAQ module is a 27-item questionnaire that assesses feelings about injections, self-image, self-confidence (regarding self-administration), pain and skin reactions during or after injection (injection-site reactions), ease of use of the self-injection device, and satisfaction with self-injection. Participants rated each item of the SIAQ on a 5-point (or 6-point) semantic Likert-type scale, where a score of 1 corresponds to a participant's worst experience and a score of 5 (or 6) corresponds to a participant's best experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item.|Baseline (Day 1)|Usability Analysis Set|||Scores on a scale||Standard Deviation|Mean
2556621|NCT02722044|Secondary|Number of Participants With Hazard-free Injections as Assessed by the Observer at Week 4|"Observers assessed usability by using a potential hazard checklist. If all potential hazards in the checklist were checked as no, the assessment was coded as hazard free."|Week 4|Usability Analysis Set|||Participants|||Count of Participants
2556622|NCT02722044|Secondary|Number of Participants With Successful Injections as Assessed by the Observer at Week 4|"Observers assessed usability by using a self-injection checklist. Self-injection assessment was coded as successful if categories P7 (removed protective needle cap from auto-injector), P10 (press down on auto-injector to insert the needle into the skin), and P11 (held auto-injector pressed fully down through second click sound) were checked as yes."|Week 4|Usability Analysis Set|||Participants|||Count of Participants
2556623|NCT02722044|Primary|Usability of the Auto-injector (AI) at Week 4|The primary usability measure was the participant rating captured in the PRE- and POST-Self-injection Assessment Questionnaire (SIAQ) modules at Week 4. The PRE-SIAQ module is a 7-item questionnaire that investigates feelings about injections, self-confidence (regarding self-administration), and satisfaction with self-injection. The POST-SIAQ module is a 27-item questionnaire that assesses feelings about injections, self-image, self-confidence (regarding self-administration), pain and skin reactions during or after injection (injection-site reactions), ease of use of the self-injection device, and satisfaction with self-injection. Participants rated each item of the SIAQ on a 5-point (or 6-point) semantic Likert-type scale, where a score of 1 corresponds to a participant's worst experience and a score of 5 (or 6) corresponds to a participant's best experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item.|Week 4|Usability Analysis Set: all participants in the Safety Analysis Set who had usability measurements at Week 4 and who did not have any deviations from the protocol deemed significant enough for exclusion from the usability analysis|||Scores on a scale||Standard Deviation|Mean
2556624|NCT02721875|Secondary|Maximum Measured Plasma Concentration of Volasertib (Cmax) (for Combination)|Maximum measured plasma concentration of volasertib (Cmax) (for combination).|PK samples were to be taken at 5 minutes before drug administration (167:55) and 168:30, 169:00, 169:30, 170:00, 171:00, 172:00, 192:00, 336:00, 504:00, 672:00 hours after first drug administration of Azacitidine|Due to premature discontinuation of the trial no patient is recruited for combination therapy.||||||
2556625|NCT02721875|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity of Volasertib (AUC0-∞) (for Combination)|Area under the plasma concentration-time curve over the time interval from zero extrapolated to infinity of volasertib (AUC0-∞) (for combination).|PK samples were to be taken at 5 minutes before drug administration (167:55) and 168:30, 169:00, 169:30, 170:00, 171:00, 172:00, 192:00, 336:00, 504:00, 672:00 hours after first drug administration of Azacitidine|Due to premature discontinuation of the trial no patient is recruited for combination therapy.||||||
2556626|NCT02721875|Secondary|Maximum Measured Plasma Concentration of Volasertib (Cmax) (for Monotherapy)|Maximum measured plasma concentration of volasertib (Cmax) (for monotherapy).|PK samples were taken at 5 minutes before drug administration and 0:30, 1:00, 2:00, 3:00, 4:00, 24:00, 167:55, 168:30, 169:00, 169:30, 170:00, 171:00, 172:00, 192:00, 336:00, 504:00, 672:00 hours after drug administration|All evaluable patients were to be included in the Pharmacokinetic (PK) analysis. Patients who were considered as not evaluable were to be listed with their individual plasma concentrations and individual PK parameters; however, they were not to be included in descriptive statistics for plasma concentrations.|||Nanogram(ng)*/milliliter(mL)|||Number
2556627|NCT02721875|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to the Last Measured Time Point tz of Volasertib (AUC0-tz) (for Monotherapy)|Area under the plasma concentration-time curve over the time interval from zero to the last measured time point tz of volasertib (AUC0-tz) (for monotherapy).|Pharmacokinetic (PK) samples were taken at 5 minutes before drug administration and 0:30, 1:00, 2:00, 3:00, 4:00, 24:00, 167:55, 168:30, 169:00, 169:30, 170:00, 171:00, 172:00, 192:00, 336:00, 504:00, 672:00 hours after drug administration|All evaluable patients were to be included in the PK analysis. Patients who were considered as not evaluable were to be listed with their individual plasma concentrations and individual PK parameters; however, they were not to be included in descriptive statistics for plasma concentrations.|||Nanogram(ng)*hour(h)/milliliter(mL)|||Number
2556628|NCT02721875|Secondary|Objective Response Defined as Best Overall Response of Complete Remission, Partial Remission or Haematological Improvement According to the International Working Group 2006 Criteria|Objective response defined as best overall response of complete remission, partial remission or haematological improvement according to the International Working Group 2006 criteria. It is based on Complete remission (CR): Bone marrow: <=5% myeloblasts with normal maturation of all cell lines, Peripheral blood: Hemoglobin >=11 Grams Per Decilitre (g/dL), Platelets >=100 x 109/L, Neutrophils >=1.0 x 109/L, Blasts 0%. Peripheral blood responses had to last at least 4 weeks to qualify for CR. Partial remission (PR): All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by >=50% to baseline but still >5%, Cellularity and morphology not relevant. Peripheral blood responses must last at least 4 weeks to qualify for PR. Haematological improvement (HI): HI was evaluated in patients with abnormal pretreatment values based on Erythroid response, Platelet response, Neutrophil response. Peripheral blood responses had to last at least 8 weeks to qualify for HI.|Up to 168 days|Treated Set|||Participants|||Number
2556629|NCT02721875|Primary|Maximum Tolerated Dose (MTD) of Volasertib|The MTD was defined as the highest dose with less than 35% risk of the true dose limiting toxicities (DLT) rate being above 0.33 for schedule A, and the highest dose with less than 40% risk of the true DLT rate being above 0.33 for schedule B. The phase I dose-finding was to be guided by a Bayesian 2-parameter logistic regression model (BLRM) with overdose control in each schedule separately.|First treatment cycle, up to 28 days|Treated Set|||Milligram (mg)/ meter square (m2)|||Number
2556630|NCT02721875|Primary|Number of Patients With Dose Limiting Toxicities (DLT) in the First Cycle|DLT was defined as any of the following adverse events (AEs) considered to be related to study drug: 1. Common terminology criteria for adverse events (CTCAE) v4.03 ≥Grade 3 drug related non- haematological toxicity, excluding; ≥Grade 3 untreated nausea, vomiting or diarrhea. Any laboratory abnormality - not considered clinically significant by investigator or resolved spontaneously or could have been recovered with appropriate treatment within 7 days. Grade 3 infection which could be recovered with appropriate treatment within 7 days. Azacitidine injection site reaction or complications related to azacitidine injection. 2. Febrile neutropenia as defined by CTCAE which could not recovered with appropriate treatment within 7 days. 3. Inability to deliver full dose of volasertib according to the assigned dose level within Cycle 1 due to drug-related AEs. 4. Haematological DLTs. 5. Any other drug-related AEs that resulted in the delay of starting new treatment cycle for ≥4 weeks.|First treatment cycle, up to 28 days|Treated Set|||Participants|||Number
2556661|NCT02721147|Secondary|Change in Anxiety Measured Using the Generalized Anxiety Disorder 7-item|Total scale scores range from 0 to 21. Higher scores indicate higher levels of anxiety. Change in mean anxiety score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in anxiety from pre- to post-intervention.|Baseline to up to 8 weeks|This scale was administered to patients only. 19/20 IE patients were analyzed because 1 patient was lost to follow-up.|||score on a scale||95% Confidence Interval|Mean
2556631|NCT02721641|Primary|Number of Participants Withdrawn From Study Because of LVEF Dysfunction|LVEF dysfunction was defined as low LVEF measured on two consecutive assessments, with the second assessment performed after 3 weeks of study medication being withheld. Low LVEF included values less than or equal to 39% or values between 40% and 45% (inclusive) with a decrease of 10 or more percentage points from Baseline.|From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)|All enrolled participants with available LVEF data were included in the analysis.|||Participants|||Count of Participants
2556632|NCT02721641|Primary|Number of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) Below 45 Percent (%)||From date of enrollment until disease progression, death, or premature withdrawal; assessed per investigator discretion (maximum 7.4 years of follow-up)|All enrolled participants with available LVEF data were included in the analysis.|||Participants|||Count of Participants
2556633|NCT02721641|Primary|On-Study Duration of Trial Treatment||From date of enrollment until death or premature withdrawal (maximum 7.4 years of follow-up)|Analysis was performed on all enrolled participants.|||days||Full Range|Median
2556634|NCT02721277|Other Pre-specified|Numbers of Blood Infection Obtained From a Central Venous Catheter|A review of the subject's medical record will determine the location from which positive blood cultures were obtained.|6 months|Study was terminated due to insufficient enrollment||||||
2556635|NCT02721277|Other Pre-specified|Numbers of Blood Infection Obtained From a Venipuncture|A review of the subject's medical record will determine the location from which positive blood cultures were obtained.|6 months|Study was terminated due to insufficient enrollment||||||
2556636|NCT02721277|Other Pre-specified|Number of Blood Infections|A review of the subject's medical record will determine the presence of bacterial, viral, or fungi colony-forming units (CFU) in the blood.|6 months|Study was terminated due to insufficient enrollment||||||
2556637|NCT02721277|Other Pre-specified|Number of Days With Central Venous Catheter||6 months|Study was terminated due to insufficient enrollment||||||
2556638|NCT02721277|Other Pre-specified|Number of Days on Oxygen Via Nasal Cannula|Length of therapy with nasal cannula|6 months|Study was terminated due to insufficient enrollment||||||
2556639|NCT02721277|Other Pre-specified|Number of Days on Oxygen Via Continuous Positive Airway Pressure|Length of therapy with nasal continuous positive airway pressure|6 months|Study was terminated due to insufficient enrollment||||||
2556640|NCT02721277|Other Pre-specified|Number of Days on Mechanical Ventilation Via Endotracheal Tube|Length of therapy with mechanical ventilation|6 months|Study was terminated due to insufficient enrollment||||||
2556641|NCT02721277|Secondary|Triglyceride|Laboratory value that evaluates liver function and metabolism of fat|6 months|Study was terminated due to insufficient enrollment||||||
2556642|NCT02721277|Secondary|Alkaline Phosphatase|Laboratory value that evaluates liver function|6 months|Study was terminated due to insufficient enrollment||||||
2556643|NCT02721277|Secondary|Serum Glucose|Laboratory values that evaluates glucose in the blood|6 months|Study was terminated due to insufficient enrollment||||||
2556644|NCT02721277|Secondary|Total Bilirubin|Laboratory value that evaluates liver function|6 months|Study was terminated due to insufficient enrollment||||||
2556645|NCT02721277|Secondary|Alanine Aminotransferase|Laboratory value that evaluates liver function|6 months|Study was terminated due to insufficient enrollment||||||
2556646|NCT02721277|Secondary|Aspartate Aminotransferase|Laboratory value that evaluates liver function|6 months|Study was terminated due to insufficient enrollment||||||
2556647|NCT02721277|Secondary|Albumin|Laboratory value that evaluates liver function|6 months|Study was terminated due to insufficient enrollment||||||
2556648|NCT02721277|Secondary|Total Protein|Laboratory value that evaluates liver function|6 months|Study was terminated due to insufficient enrollment||||||
2556649|NCT02721277|Secondary|Carbon Dioxide Total|Laboratory value that determines acid-base balance|6 months|Study was terminated due to insufficient enrollment||||||
2556650|NCT02721277|Secondary|Number of Participants With Adverse Events Related to Treatment|Laboratory values will be used to determine adverse events.|6 months|Study was terminated due to insufficient enrollment||||||
2556651|NCT02721277|Secondary|Number of Subjects Receiving Breast Milk Diet|Enteral administration of breast milk will be noted|6 months|Study was terminated due to insufficient enrollment||||||
2556652|NCT02721277|Secondary|Number of Subjects Receiving Formula Diet|Enteral administration of formula will be noted|6 months|Study was terminated due to insufficient enrollment||||||
2556653|NCT02721277|Secondary|Length of IV Nutritional Therapy||6 months|Study was terminated due to insufficient enrollment||||||
2556654|NCT02721277|Secondary|Number of Concomitant Medications Received||6 months|Study was terminated due to insufficient enrollment||||||
2556655|NCT02721277|Secondary|Number of Subjects Requiring Surgery||6 months|Study was terminated due to insufficient enrollment||||||
2556656|NCT02721277|Secondary|Measurement of Length for Growth Increase|Growth increase will be measured by length of participants.|6 months|Study was terminated due to insufficient enrollment||||||
2556657|NCT02721277|Secondary|Measurement of Weight for Growth Increase|Growth increase will be measured by weight of participants.|6 months|Study was terminated due to insufficient enrollment||||||
2556658|NCT02721277|Secondary|Measurement of Head Circumference for Growth Increase|Growth increase will be measured by head circumference of participants.|6 months|Study was terminated due to insufficient enrollment||||||
2556659|NCT02721277|Primary|Inflammation of the Liver Between the Groups|Inflammation of the liver will be evaluated by comparing direct bilirubin values between the two groups.|6 months|Study was terminated due to insufficient enrollment||||||
2556660|NCT02721147|Secondary|Change in Cancer-related Distress Using the Impact of Events Scale-Revised|Total scale scores range from 0 to 88. Higher scores indicate higher levels of distress. Change in mean cancer-related distress score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in distress from pre- to post-intervention.|Baseline to up to 8 weeks|This scale was administered to both patients and partners. 38/40 IE participants were analyzed because 2 participants were lost to follow-up.|||score on a scale||95% Confidence Interval|Mean
2556662|NCT02721147|Secondary|Change in Depression Measured Using the Patient Health Questionnaire-9 Item|Total scale scores range from 0 to 27. Higher scores indicate higher level of depression. Change in mean depression score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in depression from pre- to post-intervention.|Baseline to up to 8 weeks|This scale was administered to patients only. 19/20 IE patients were analyzed because 1 patient was lost to follow-up.|||score on a scale||95% Confidence Interval|Mean
2556663|NCT02721147|Secondary|Change in Body Image Distress Measured Using the Body Image Scale|Total scale scores range from 0 to 30. Higher scores indicate higher level of body image distress. Change in mean body image distress score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in body image distress from pre- to post-intervention.|Baseline to up to 8 weeks|This scale was administered to patients only. 19/20 IE patients were analyzed because 1 patient was lost to follow-up.|||score on a scale||95% Confidence Interval|Mean
2556664|NCT02721147|Secondary|Change in Relationship Quality Measured Using the Dyadic Adjustment Scale-7 Item|Total scale scores range from 0 to 36. Higher scores indicate higher relationship quality. Change in mean relationship quality score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in relationship quality from pre- to post-intervention.|Baseline to up to 8 weeks|This scale was administered to both patients and partners. 38/40 IE participants were analyzed because 2 participants were lost to follow-up.|||score on a scale||95% Confidence Interval|Mean
2556665|NCT02721147|Secondary|Change in Sexual Communication Measured Using the Dyadic Sexual Communication Scale|Total scale scores range from 13 to 78. Higher scores indicate more communication. Change in mean sexual communication score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in sexual communication from pre- to post-intervention.|Baseline to up to 8 weeks|This scale was administered to both patients and partners. 38/40 IE participants were analyzed because 2 participants were lost to follow-up.|||score on a scale||95% Confidence Interval|Mean
2556666|NCT02721147|Secondary|Change in Emotional Intimacy Measured Using the Personal Assessment of Intimacy in Relationships (PAIR) Emotional Intimacy Scale|Total scale scores range from 1 to 5. Higher scores indicate higher level of emotional intimacy with one's partner. Change in mean emotional intimacy score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in emotional intimacy from pre- to post-intervention.|Baseline to up to 8 weeks|This scale was administered to both patients and partners. 38/40 IE participants were analyzed because 2 participants were lost to follow-up.|||score on a scale||95% Confidence Interval|Mean
2556667|NCT02721147|Secondary|Change in Beliefs (Self-efficacy)|Total scale scores range from 0 to 100. Higher scores indicate higher degree of self-efficacy for coping with sexual concerns. Change in mean self-efficacy score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in self-efficacy from pre- to post-intervention.|Baseline to up to 8 weeks|This scale was administered to both patients and partners. 38/40 IE participants analyzed because 2 participants were lost to follow-up. 17/18 Educational Control participants were analyzed because 1 participant did not complete the scale at follow-up.|||score on a scale||95% Confidence Interval|Mean
2556668|NCT02721147|Secondary|Change in Sexual Distress Measured Using the Female Sexual Distress Scale-Revised|Total scale scores range from 0 to 52. Higher scores indicate higher levels of sexual distress. Change in patient mean sexual distress score from pre-intervention to post-intervention is reported. Negative mean change scores indicate decrease in sexual distress from pre- to post-intervention.|Baseline to up to 8 weeks|This scale was administered to patients only. 19/20 IE patients were analyzed because 1 patient was lost to follow-up.|||score on a scale||95% Confidence Interval|Mean
2556669|NCT02721147|Secondary|Change in Sexual Satisfaction Measured Using the Patient-Reported-Outcomes Measurement Information System (PROMIS) Sexual Satisfaction Items|The PROMIS uses T-scores that are calculated against U.S. population norms with a M of 50 and SD of 10. Higher T-scores indicate higher levels of sexual satisfaction. Change in sexual satisfaction T-scores from pre-intervention to post-intervention are reported. Positive change scores indicate increase in sexual satisfaction from pre- to post-intervention.|Baseline to up to 8 weeks|This scale was administered to both patients and partners. 38/40 IE participants analyzed because 2 participants were lost to follow-up.|||score on a scale||95% Confidence Interval|Mean
2556670|NCT02721147|Secondary|Change in Sexual Function Measured Using the International Index of Erectile Function|Total scale scores range from 1 to 75, with higher scores indicating a higher level of sexual functioning. Change in mean male partner IIEF score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in sexual functioning from pre- to post-intervention.|Baseline to up to 8 weeks|This measure was administered to male partners. 7/9 partners in the educational control arm were analyzed because 1 partner was female and 1 partner had incomplete data at follow-up. 19/20 partners in the IE condition were analyzed because 1 partner did not complete follow-up.|||score on a scale||95% Confidence Interval|Mean
2556671|NCT02721147|Secondary|Change in Sexual Function Measured Using the Female Sexual Function Index (FSFI)|Total scale scores range from 2 to 36. Higher scores indicate higher level of functioning. Change in mean patient FSFI score from pre-intervention to post-intervention is reported. Positive mean change scores indicate increase in sexual functioning from pre- to post-intervention.|Baseline to up to 8 weeks|This outcome is female-specific and was only measured in patients. 19/20 IE patients were analyzed because 1 patient was lost to follow-up.|||score on a scale||95% Confidence Interval|Mean
2556672|NCT02721147|Primary|Acceptability Measured Using the Client Satisfaction Questionnaire (CSQ-8)|Acceptability was measured through the median score on a validated acceptability measure. Item responses run on a scale of 1 to 4, with a total score range of 8-32. Higher scores indicate higher satisfaction with the service (acceptability). A median score of 28 or higher is considered acceptable. This measure was collected for both patients and partners.|Up to 8 weeks|36/40 participants assigned to the IE condition were analyzed (2 participants did not complete sessions and were not given any measures assessing satisfaction with the sessions; 2 participants did not return the post-intervention survey).|||score on a scale||Standard Deviation|Median
2556673|NCT02721147|Primary|Feasibility of the Treatment as Measured Through Session Completion by Participant|Feasibility of the treatment as measured through number of randomized participants who completed all 4 telephone sessions.|Up to 8 weeks||||Participants|||Count of Participants
2556675|NCT02721147|Primary|Feasibility of the Treatment as Measured Through Study Accrual|Feasibility is measured through the percentage of study eligible individuals who enrolled in the intervention study (i.e., acceptance rate).|Up to 8 weeks|182 eligible individuals were approached for the intervention study and were either classified as study refusers or acceptors.|||Participants|||Count of Participants
2556676|NCT02720952|Secondary|Incidence of Serious Adverse Events (SAEs) and Adverse Events (AE)|"SAEs and AEs reported over the study period.~N.B., Data will not be entered in this section as this is described within the Adverse Events section."|7-10 days|||||||
2556677|NCT02720952|Secondary|Subject Assessment of Taste of the Product|"Palatability of the investigational product as determined by parent/carer responses to the following questions:~Question 1: My child found swallowing easy. Question 2: My child showed a positive reaction after Infacort was given. Question 3: I would be happy to give my child Infacort in the future. Question 4: Overall, I would prefer Infacort for my child over the usual hydrocortisone medication."|1 minute||||Participants|||Count of Participants
2556678|NCT02720952|Secondary|Serum Cortisol Concentration up to 6 Hours|Serum cortisol concentration 240 minutes after intake of study drug as determined by the central laboratory|240 minutes||||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2556679|NCT02720952|Primary|Serum Cortisol Concentration up to 240 Minutes|The primary endpoint will be the maximum levels of serum cortisol concentration up to 240 minutes after intake of study drug as determined by the central laboratory.|240 minutes||||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2556680|NCT02720757|Secondary|Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Handling of the Respimat® Inhalation Device|"A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied.~Count of patients with divisions from very dissatisfied to very satisfied are presented."|Visit 2 (approx. 6 weeks post baseline)|FAS|||Participants|||Count of Participants
2556681|NCT02720757|Secondary|Patient Satisfaction With Spiolto® Respimat® - Satisfaction With Inhaling From the Respimat® Device|"A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied.~Count of patients with divisions from very dissatisfied to very satisfied are presented."|Visit 2 (approx. 6 weeks post baseline)|FAS|||Participants|||Count of Participants
2556682|NCT02720757|Secondary|Patient Satisfaction With Spiolto® Respimat® - Overall Satisfaction|"A patient satisfaction survey is completed at Visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied.~Count of patients with divisions from very dissatisfied to very satisfied are presented."|Visit 2 (approx. 6 weeks post baseline)|FAS|||Participants|||Count of Participants
2556683|NCT02720757|Secondary|General Condition of the Patient Evaluated by the Physician: Physicians' Global Evaluation (PGE)-Score at Visit 1 (Baseline) and at Visit 2 (Approx. 6 Weeks Later)|"The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8(excellent). PGE will be completed before and approx. 6 weeks after treatment initiation.~Count of patients with PGE score 2, 3, 4, 5, 6, 7, 8 are presented for Visit 1 and Visit 2."|Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)|FAS|||Participants|||Count of Participants
2556684|NCT02720757|Secondary|Change in the PF-10 Score From Visit 1 (Baseline) to Visit 2 (Approx. 6 Weeks Later)|"Change in PF-10 score was determined by taking into account the individual change of each patient between Visit 1 and Visit 2.~PF questionnaire, is a sub-domain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with yes, limited a lot, yes, limited a little, or No, not limited at all, with a score of 1, 2, or 3. The scores over the 10 questions will be summed, resulting in a value between 10 (a patient answering all questions with yes, limited a lot) and 30 (a patient answering all questions with No, not limited at all). The final sum of the individual scores will be standardized to a range of 0 to 100 using the following formula: 100*(sum-10)/20."|Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)|FAS|||scores on a scale||Standard Deviation|Mean
2556685|NCT02720757|Primary|Percentage of Patients With Therapeutic Success After Approximately (Approx.) 6 Weeks After Baseline|"Therapeutic success is defined as a 10-point increase of physical functioning (PF)-10 between Visit 1 (baseline) and Visit 2 (approx. 6 weeks later) using a PF questionnaire, which is a subdomain of the Short form (SF)-36 patient questionnaire. The PF-10 sub-domain consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. Each question of the PF-10 can be answered with yes, limited a lot, yes, limited a little, or No, not limited at all, with a score of 1, 2, or 3. The scores over the 10 questions will be summed, resulting in a value between 10 (a patient answering all questions with yes, limited a lot) and 30 (a patient answering all questions with No, not limited at all). The final sum of the individual scores will be standardized to a range of 0 to 100 using the following formula: 100*(sum-10)/20.~Percentage of patients with therapeutic success after approximately 6 weeks after baseline are presented"|Visit 1 (baseline) and at Visit 2 (approx. 6 weeks later)|Full analysis set (FAS): Patients that were enrolled, registered and received at least one dose of treatment with Spiolto® Respimat® and had baseline and week 6 visit documented as well as completed all questionnaires were included in FAS|||percentage of participants||95% Confidence Interval|Number
2556686|NCT02720536|Secondary|Percentage Relative Change From Baseline of Serum Ferritin (%) at Month 6 and 12|The percentage relative change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Percentage relative change = 100 × ([Post - Baseline] / Baseline). Percentage relative change is calculated for each patient individually and then overall descriptive summary statistics is obtained for subjects with a value at baseline and the particular time point. A negative percentage relative change from baseline is regarded as an improvement in this study|Baseline, 6 and 12 months|Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest|||percentage of relative change||Standard Deviation|Mean
2556799|NCT02719743|Secondary|Duration of Solicited General Symptoms.|Duration was defined as number of days with any grade of general symptoms.|During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Days||Inter-Quartile Range|Median
2556687|NCT02720536|Secondary|Change From Baseline of Serum Ferritin Level (ug/L) at Month 6 and 12|The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline. A negative change from baseline is regarded as an improvement in this study|Baseline, 6 and 12 months|Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest|||ug/l||Standard Deviation|Mean
2556688|NCT02720536|Primary|Change From Baseline Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) (U/L) at Month 6 and Month 12|The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline|Baseline, 6 and 12 months|Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest|||U/L||Standard Deviation|Mean
2556689|NCT02720536|Primary|Change From Baseline Alanine Aminotransferase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) (U/L) at Month 6 and Month 12|The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline|Baseline, 6 and 12 months|Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest|||U/L||Standard Deviation|Mean
2556690|NCT02720536|Primary|Change From Baseline Creatinine Clearance (mL/Min) at Month 6 and Month 12|The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline|Baseline, 6 and 12 months|Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest|||mL/min||Standard Deviation|Mean
2556691|NCT02720536|Primary|Change From Baseline Serum Creatinine (Umol/L) at Month 6 and Month 12|The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline|Baseline, 6 and 12 months|Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest|||umol/L||Standard Deviation|Mean
2556692|NCT02720536|Primary|Change From Baseline Platelets (10^9 Cells/L) at Month 6 and Month 12|The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline|Baseline, 6 and 12 months|Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest|||10^9 cells/L||Standard Deviation|Mean
2556693|NCT02720536|Primary|Change From Baseline White Blood Cells (WBC) (10^9 Cells/L) at Month 6 and Month 12|The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline|Baseline, 6 and 12 months|Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest|||10^9 cells/L||Standard Deviation|Mean
2556694|NCT02720536|Primary|Change From Baseline Red Blood Cells (RBC) (10^12 Cells/L) at Month 6 and Month 12|The change from baseline at each time point is calculated only for subjects with a value at baseline and the particular time point. Post = Post baseline, Change = Post - Baseline|Baseline, 6 and 12 months|Safety analysis set - at each timepoint the subjects from the safety analysis set who have a value of the lab parameter of interest at both baseline and the timepoint of interest|||10^12 cells/L||Standard Deviation|Mean
2556695|NCT02720536|Primary|Overview of Number of Participants With Adverse Events|Numbers represent counts of participants within the categories. An adverse event (AE) was defined as treatment emergent if its onset date is on or after (≥) the first administration of study treatment within this study or events present prior to start of study treatment but increased in severity on or after (≥) the first administration of study treatment within this study but not later than 30 days after the last study treatment in this study|Baseline up to approximately 25 months|Safety analysis set|||number of participants|||Number
2556696|NCT02720523|Secondary|Change From Baseline in the Severity of Morning Stiffness at Week 12|Morning stiffness severity was determined by the Patient's Assessment of Severity and Duration of Morning Stiffness questionnaire. Participants rated the severity of morning stiffness on awakening over the past 7 days on a scale from 0 (No morning stiffness) to 10 (Worst possible morning stiffness).|Baseline and Week 12|Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2556697|NCT02720523|Secondary|Change From Baseline in Rheumatoid Arthritis Work Instability Scale (RA-WIS) at Week 12|"RA-WIS is a simple validated tool to evaluate work instability (the consequence of a mismatch between an individual's functional ability and their work tasks). RA-WIS consists of 23 questions relating to the participant's functioning in their work environment, each answered as Yes or No. The total score is the number of questions answered Yes, and ranges from 0 to 23.~A score < 10 means low risk and no action is needed, scores between 10 and 17 indicate medium risk and appropriate advice and information should be given. If the score is > 17, it means high risk and it could warrant referral.~A negative change from Baseline indicates improvement."|Baseline and Week 12|Full analysis set participants who were working and with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.|||scores on a scale||95% Confidence Interval|Geometric Least Squares Mean
2556698|NCT02720523|Secondary|Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) at Week 12|The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement.|Baseline and Week 12|Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2556699|NCT02720523|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:~≥ 20% improvement in 68-tender joint count;~≥ 20% improvement in 66-swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 1|Full analysis set; participants who prematurely discontinued from study drug prior to Week 1 or for whom ACR data were missing at Week 1 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2556700|NCT02720523|Secondary|Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12|Clinical remission was defined as a DAS28 (CRP) score less than 2.6. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.|Week 12|Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2556701|NCT02720523|Secondary|Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12|Low disease activity. was defined as a DAS28 score less than or equal to 3.2. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.|Week 12|Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2556702|NCT02720523|Secondary|Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12|"The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).~The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement."|Baseline and Week 12|Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2556703|NCT02720523|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:~≥ 70% improvement in 68-tender joint count;~≥ 70% improvement in 66-swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 12|Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2556704|NCT02720523|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:~≥ 50% improvement in 68-tender joint count;~≥ 50% improvement in 66-swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 12|Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2556705|NCT02720523|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12|"The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.~A negative change from Baseline in the overall score indicates improvement."|Baseline and Week 12|Full analysis set participants with available data at baseline; multiple imputation was used for missing data.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2556706|NCT02720523|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) (CRP) at Week 12|The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.|Baseline and Week 12|Full analysis set; multiple imputation was used for missing data.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2556724|NCT02720484|Secondary|Progression-free Survival (PFS)|Progression Free Survival (PFS) of nivolumab treatment in patients with metastatic adrenocortical carcinoma is defined as the duration of time from start of treatment to time of documented progression or death, whichever comes first. It will measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI scans every 8 weeks.|From start of treatment and every 8 weeks/2 cycles until progressive disease or death. Median follow up of 4.5 months||||Months||95% Confidence Interval|Median
2556707|NCT02720523|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:~≥ 20% improvement in 68-tender joint count;~≥ 20% improvement in 66-swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 12|Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2556708|NCT02720510|Secondary|Progression Free Survival||3 years after the last patient is enrolled to the study|The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated.||||||
2556709|NCT02720510|Secondary|Overall Survival||3 years after the last patient is enrolled to the study|The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated..||||||
2556710|NCT02720510|Secondary|Duration of Response||From measurable response to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.|The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated.||||||
2556711|NCT02720510|Secondary|Depth of Response by International Myeloma Working Group (IMWG) Criteria|Rate of Very Good Partial Response (VGPR), Complete Response (CR) and Stringent Complete Response (sCR)|Day 22 up to end of study, approximately 3 years|The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated.||||||
2556712|NCT02720510|Secondary|Best Overall Response Rate (ORR) and MRD Negativity After ASCT and Maintenance|ORR (CR + PR) and MRD negativity after ASCT and maintenance|Month 3 up to end of study, approximately 3 years.|The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated.||||||
2556713|NCT02720510|Secondary|Minimal Residual Disease (MRD) Negativity (mCR) After 4 Cycles of Induction by Next Gen Sequencing|MRD negativity by Clonal Sequencing (ClonoSEQTM) assay (Adaptive Biotechnologies)|Month 3|The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated.||||||
2556714|NCT02720510|Primary|Near Complete Response (nCR)/CR Rate of the Combination of Panobinostat With Bortezomib, Lenalidomide and Dexamethasone (P-RVD) vs RVD in Newly Diagnosed Multiple Myeloma Patients||84 days|The study was terminated prematurely and because only 6 patients were enrolled, efficacy data were not evaluated.||||||
2556715|NCT02720484|Post-Hoc|Progression Free Survival Rate at 3 Months and 6 Months|Progression Free Survival (PFS) of nivolumab treatment in patients with metastatic adrenocortical carcinoma is defined as the duration of time from start of treatment to time of documented progression or death, whichever comes first. It will measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI scans every 8 weeks. PRS rate at 3 months and 6 months will be calculated as the percentage of patients that have not yet progressed at that timepoint.|At 3 months and 6 months from the initiation of treatment||||percentage of patients with PFS||95% Confidence Interval|Number
2556716|NCT02720484|Other Pre-specified|Serum Interleukin Levels|Serum interleukin levels will assist in assessing Overall response rate, PFS, and OS for this treatment.|At baseline and at 4 weeks of treatment|||||||
2556717|NCT02720484|Other Pre-specified|Peripheral T Cell Profile Levels|Peripheral T cell profile levels will assist in assessing Overall response rate, PFS, and OS for this treatment.|At baseline and at 4 weeks of treatment|||||||
2556718|NCT02720484|Other Pre-specified|PD-L2 Expression|PD-L2 expression will assist in assessing Overall response rate, PFS, and OS for this treatment.|At baseline and at 4 weeks of treatment|||||||
2556719|NCT02720484|Other Pre-specified|PD-L1 Expression|PD-L1 expression will assist in assessing Overall response rate, PFS, and OS for this treatment.|At baseline and at 4 weeks of treatment|||||||
2556720|NCT02720484|Other Pre-specified|Levels of Peripheral Blood Lymphocyte Phenotype|Humoral and cellular responses to tumor antigens on serum samples will be evaluated by measuring the levels of peripheral blood lymphocyte phenotype. Potential correlations between differential measures of response and the toxicity and efficacy of nivolumab will be explored.|At baseline and at 4 weeks of treatment|||||||
2556721|NCT02720484|Other Pre-specified|Levels of Cytokines|Humoral and cellular responses to tumor antigens on serum samples will be evaluated by measuring the levels of cytokines (ie, IL-2, IL-6, IL-8, IL-10, IL-18, IFN gamma and TNF-alpha). Potential correlations between differential measures of response and the toxicity and efficacy of nivolumab will be explored.|At baseline and at 4 weeks of treatment|||||||
2556722|NCT02720484|Secondary|Toxicity of Nivolumab|"Safety and tolerability profile of Nivolumab will be assessed by describing by number, frequency, and severity of Adverse Events (AEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.3. All AEs that were considered related to Nivolumab were collected and are shown below. Patients with multiple events in the same category are counted only once in that category. Patients with events in more than one category are counted in each of those categories. Categories with no events are not shown.~In general AEs will be graded according to the following:~Grade 1 = Mild AE Grade 2= Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE"|From treatment initiation, twice every Cycle (every 14 days) while on treatment, up to 12 weeks after final dose. Range of cycles completed 1-15 (1 Cycle=28 days)||||participants|||Number
2556723|NCT02720484|Secondary|Overall Survival (OS) at 3 Months and 6 Months|Overall Survival (OS) of nivolumab treatment in patients with metastatic adrenocortical carcinoma and will be defined as the duration of time from treatment initiation until death. OS will be assessed as the percentage of patients alive at 3 months and at 6 months from initiation of treatment on study.|At 3 months and 6 months from the initiation of treatment||||percentage of patients alive||95% Confidence Interval|Number
2556770|NCT02720081|Secondary|Change From Baseline in Systolic Blood Pressure at Week 6|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, systolic blood pressure.|||mmHg||Standard Deviation|Mean
2556725|NCT02720484|Primary|Overall Response Rate|"Overall Response Rate of nivolumab treatment for patients with metastatic adrenocortical carcinoma will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI scans every 8 weeks:~Complete Response (CR) = disappearance of all target lesions. Partial Response (PR) >=30% decrease in the sum of the longest diameter of target lesions (should be confirmed 8 weeks after initial response otherwise considered unconfirmed PR).~Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.~Progressive Disease, defined as having at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.."|From the start of treatment and every 8 weeks/2 cycles with a range of cycles attempted 1-15.|All patients that received one dose of nivolumab were evaluable for this objective.|||Participants|||Count of Participants
2556726|NCT02720224|Secondary|Number of Subjects With Adverse Events as a Measure of Safety and Tolerability||From maximum 28 days prior study treatment intake to 240 hours post-dose|Safety population - all subjects who took one dose of study treatment|||Participants|||Count of Participants
2556727|NCT02720224|Secondary|Renal Clearance (CLr) for Total Radioactivity||From Day-1 prior study treatment intake to 240 hours post-dose|"PK and mass balance populations - n = all subjects who took one dose of study treatment and had sufficient quantifiable post-dose samples (plasma, urinary and faecal) for PK and mass balance parameter estimation.~One subject was excluded from the CLr analysis due to undetectable PK samples from 4 to 24 hours post E4 dose."|||mL/min||Geometric Coefficient of Variation|Geometric Least Squares Mean
2556728|NCT02720224|Secondary|Renal Clearance (CLr) for Estetrol||From Day-1 prior study treatment intake to 240 hours post-dose|PK and mass balance populations - n = all subjects who took one dose of study treatment and had sufficient quantifiable post-dose samples (plasma, urinary and faecal) for PK and mass balance parameter estimation.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2556729|NCT02720224|Secondary|AUC(0-last) of Total Radioactivity in Whole Blood||Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose|PK population - n = all subjects who took one dose of study treatment and had sufficient quantifiable post-dose plasma concentration for PK parameter estimation.|||ng eq*h/mL||Geometric Coefficient of Variation|Geometric Mean
2556730|NCT02720224|Secondary|The Terminal Elimination Rate Constant (Lambda-z) of Estetrol in Plasma||Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose|PK population - n = all subjects who took one dose of study treatment and had sufficient quantifiable post-dose plasma concentration for PK parameter estimation.|||1/hour||Geometric Coefficient of Variation|Geometric Mean
2556731|NCT02720224|Secondary|Cmax of Total Radioactivity in Whole Blood||Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose|PK population - n = all subjects who took one dose of study treatment and had sufficient quantifiable post-dose plasma concentration for PK parameter estimation.|||ng eq/mL||Geometric Coefficient of Variation|Geometric Mean
2556732|NCT02720224|Secondary|The Mean Residence Time (MRT) of Estetrol in Plasma||Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose|PK population - n = all subjects who took one dose of study treatment and had sufficient quantifiable post-dose plasma concentration for PK parameter estimation.|||hour||Geometric Coefficient of Variation|Geometric Mean
2556733|NCT02720224|Secondary|Half-life (t1/2) of Estetrol in Plasma||Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose|PK population - n = all subjects who took one dose of study treatment and had sufficient quantifiable post-dose plasma concentration for PK parameter estimation.|||hour||Geometric Coefficient of Variation|Geometric Mean
2556734|NCT02720224|Secondary|Tlag of Estetrol in Plasma||Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose|PK population - n = all subjects who took one dose of study treatment and had sufficient quantifiable post-dose plasma concentration for PK parameter estimation.|||hour||Full Range|Median
2556735|NCT02720224|Secondary|AUC(0-infinity) of Estetrol in Plasma||Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose|PK population - n = all subjects who took one dose of study treatment and had sufficient quantifiable post-dose plasma concentration for PK parameter estimation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2556736|NCT02720224|Secondary|AUC(0-last) of Estetrol in Plasma||Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose|PK population - n = all subjects who took one dose of study treatment and had sufficient quantifiable post-dose plasma concentration for PK parameter estimation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2556737|NCT02720224|Secondary|Tmax of Estetrol in Plasma||Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose|PK population - n = all subjects who took one dose of study treatment and had sufficient quantifiable post-dose plasma concentration for PK parameter estimation.|||hour||Full Range|Median
2556738|NCT02720224|Secondary|Cmax of Estetrol in Plasma||Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose|PK population - n = all subjects who took one dose of study treatment and had sufficient quantifiable post-dose plasma concentration for PK parameter estimation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2556739|NCT02720224|Secondary|The Elapsed Time (Tlag) of Total Radioactivity in Plasma||Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose|PK population - n = all subjects who took one dose of study treatment and had sufficient quantifiable post-dose plasma concentration for PK parameter estimation.|||hour||Full Range|Median
2556943|NCT02717754|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Oseltamivir and RO0640802|Tmax is time of observed maximum plasma concentration. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.|||hour||Standard Deviation|Mean
2556740|NCT02720224|Secondary|Area Under the Curve From 0 Time to Last Measurable Concentration [AUC(0-last)] of Total Radioactivity in Plasma||Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose|"PK population - n = all subjects who took one dose of study treatment and had sufficient quantifiable post-dose plasma concentration for PK parameter estimation.~One subject was excluded from the AUC0-last calculation due to undetectable samples from 4 to 24 hours post E4 dose."|||ng*h/mL||Full Range|Median
2556741|NCT02720224|Secondary|Time to Maximum Concentration (Tmax) of Total Radioactivity in Plasma||Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose|PK population - n = all subjects who took one dose of study treatment and had sufficient quantifiable post-dose plasma concentration for PK parameter estimation.|||hour||Full Range|Median
2556742|NCT02720224|Secondary|Maximum Concentration (Cmax) of Total Radioactivity in Plasma||Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose|Pharmacokinetic (PK) population - n = all subjects who took one dose of study treatment and had sufficient quantifiable post-dose plasma concentration for PK parameter estimation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2556743|NCT02720224|Primary|Mass Balance of Total Radioactivity in Faeces:|Amount excreted in faeces (Ae[faeces])|From Day -1 prior study treatment intake to 312 hours post-dose|Mass balance population - n = all subjects who took one dose of study treatment and had evaluable total radioactivity concentration (urinary and faecal) data.|||Cumulative percent excreted (%)||Standard Deviation|Mean
2556744|NCT02720224|Primary|Mass Balance of Total Radioactivity in Urine|Amount excreted in urine (Ae[urine])|From Day -1 prior study treatment intake to 312 hours post-dose|Mass balance population - n = all subjects who took one dose of study treatment and had evaluable total radioactivity concentration (urinary and faecal) data.|||Cumulative percent excreted (%)||Standard Deviation|Mean
2556745|NCT02720198|Secondary|Changes in Sexual Dysfunction by Changes in Scores on Arizona Sexual Experience Scale (ASEX)|ASEX is scale for sexual dysfunction to assess safety and tolerability of medication. Total scores range from 5-30. Higher scores indicate greater sexual dysfunction.|Baseline to Week 8||||score on a scale||Standard Deviation|Mean
2556746|NCT02720198|Secondary|Changes in Scores on Apathy Evaluation Scale (AES).|Self-Administered assessment measuring lack of motivation not attributable to diminished level of consciousness, cognitive impairment, or emotional distress. Total scores range from 0-54. Higher scores indicate greater apathy.|Baseline to Week 8||||score on a scale||Standard Deviation|Mean
2556747|NCT02720198|Secondary|Changes of Quality of Life in Scores on Sheehan Disability Scale (SDS) Total|A self-reported brief scale to assess impairment of work/school, social life and family and home. Total score range of 0-30. A higher score indicates greater impairment.|Baseline to Week 8||||score on a scale||Standard Deviation|Mean
2556748|NCT02720198|Secondary|Changes of Anxiety Symptoms in Scores on Hamilton Anxiety Rating Scale (HAM-A)|A questionnaire used by clinicians to rate the severity of a patient's anxiety. Total score range of 0-48. A higher score indicates greater anxiety.|Baseline to Week 8|Data not available for all subjects.|||score on a scale||Standard Deviation|Mean
2556749|NCT02720198|Secondary|Number of Subjects With General Improvement in Scores on Clinical Global Impression Scale- Improvement (CGI-I)|CGI-I a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is used to assess the clinician's view of the patient's global functioning. Total score range of 0-7.|Baseline to Week 8|Data not available for some participants.|||Participants|||Count of Participants
2556750|NCT02720198|Secondary|Number of Subjects With Global Improvement in Scores on Clinical Global Impression Scale- Severity (CGI-S)|CGI-S is a 7 point scale that assess the severity of illness and requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is used to assess the clinician's view of the patient's global functioning. Total score range of 0-7.|Baseline to Week 8||||Participants|||Count of Participants
2556751|NCT02720198|Secondary|Changes in Neurocognition by Changes in Scores on Scores on Digit Symbol Substitution Test (DSST)|DSST measures working memory and visuospatial processing. 1 point for each object correctly substituted from number to each matched symbol. Total score range of 0-89. Higher scores mean better cognitive function.|Baseline to Week 8||||score on a scale||Standard Deviation|Mean
2556752|NCT02720198|Secondary|Changes in Neurocognition by Changes in Scores on Reyes Verbal Learning Test|Number of words correctly recalled by the respondent is recorded. 1 point for each word correctly recalled. Total score range of 0-40. Higher scores mean better cognitive function.|Baseline to Week 8||||score on a scale||Standard Deviation|Mean
2556753|NCT02720198|Secondary|Remission Rate|Remission was defined as [>or=50% reduction in MADRS score with MADRS <or=10]|Week 8|Data not available on some participants.|||Participants|||Count of Participants
2556754|NCT02720198|Secondary|Response Rate|Remission was defined as [>or=50% reduction in MADRS score with MADRS <or=10] and response was defined as [>or=50% reduction in MADRS with MADRS >10]. Response rate included remission and response.|Week 8|Data not available on some participants.|||Participants|||Count of Participants
2556755|NCT02720198|Primary|Changes of Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|A ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Total scores will range from 0 to 60. Higher scores indicate greater severity of depressive episodes.|Baseline to Week 8|Data not available on some participants.|||score on a scale||Standard Deviation|Mean
2556756|NCT02720107|Secondary|Change in Immune Status of B Cells, Monocytes and Natural Killer Cells (NK) Cells (FAS)|Changes in immune status of B cells (CD19+, CD20+, CD69+), monocytes (CD14+) and NK cells (CD56+) were analyzed as a percentage of parent cell population (CD4+, CD8+ or total lymphocytes) by flow cytometry|Baseline up to approximately 48 months|analysis required valid samples for baseline and month 48|||percentage of parent population||Standard Error|Least Squares Mean
2556771|NCT02720081|Secondary|Change From Baseline in Systolic Blood Pressure at Week 4|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 4|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 4 for the analysis endpoint, systolic blood pressure.|||mmHg||Standard Deviation|Mean
2556757|NCT02720107|Secondary|Change From Baseline in Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at Month 6 and Month 48 (FAS)|"EDSS is a scale for assessing neurologic impairment in MS. It is a two-part system including~(1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The definition of disability progression was based on increases in EDSS from baseline and depended on the EDSS baseline value: Disability progression was defined as a 1.5 increase in EDSS from baseline in subjects with a baseline EDSS score between 0.0 and 0.5, as a 1.0 increase in EDSS from baseline in subjects with a baseline EDSS score between 1.0 and 5.0 inclusive and 0.5 increase from baseline in subjects with EDSS score > 5.0."|Baseline, month 6 up to approximately 48 months||||scores on a scale||Standard Deviation|Mean
2556758|NCT02720107|Secondary|Percentage of Participants With Disability Progression as Measured by Expanded Disability Status Scale (EDSS) (FAS)|"EDSS is a scale for assessing neurologic impairment in MS. It is a two-part system including~(1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The definition of disability progression was based on increases in EDSS from baseline and depended on the EDSS baseline value: Disability progression was defined as a 1.5 increase in EDSS from baseline in subjects with a baseline EDSS score between 0.0 and 0.5, as a 1.0 increase in EDSS from baseline in subjects with a baseline EDSS score between 1.0 and 5.0 inclusive and 0.5 increase from baseline in subjects with EDSS score > 5.0."|Baseline up to approximately 48 months||||percentage of participants|||Number
2556759|NCT02720107|Primary|Change in T Cells Status (Decrease or Increase) at Month 48 (FAS)|Aim of trial was to was to show reduction of CD4+ and CD8+ naïve T cells (CCR7+CD45RA+), central memory T cells (CCR7+CD45RA-), central memory Th17 cells (CD4+ CCR4+ and CCR6+), and an elevation of 2 types of effector memory T cells TEM (CCR7- CD45RA-) and TEMRA (CCR7- CD45RA+) in peripheral venous blood. Changes from baseline to month 48 in biomarkers were analyzed for all patients in the FAS.|Baseline up to approximately 48 months|required baseline and month 48 visit measurement of the respective cell count|||percentage of parent population||Standard Error|Least Squares Mean
2556760|NCT02720081|Primary|Average Change From Baseline in Pre-dose FEV1 at Week 4 and Week 6|FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. Data presented represents the average change from baseline at Week 4 and Week 6.|Before the first dose (Baseline) and at the end of Weeks 4 and 6 of treatment|Analysis population consists of randomized participants who received at least 1 dose of study drug.|||Liter||95% Confidence Interval|Least Squares Mean
2556761|NCT02720081|Secondary|Change From Baseline in Respiratory Rate at Week 6|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, respiratory rate.|||breaths/min||Standard Deviation|Mean
2556762|NCT02720081|Secondary|Change From Baseline in Respiratory Rate at Week 4|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 4|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 4 for the analysis endpoint, respiratory rate.|||breaths/min||Standard Deviation|Mean
2556763|NCT02720081|Secondary|Change From Baseline in Respiratory Rate at Week 2|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 2|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 2 for the analysis endpoint, respiratory rate.|||breaths/min||Standard Deviation|Mean
2556764|NCT02720081|Secondary|Change From Baseline in Heart Rate at Week 6|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, heart rate.|||beats/min||Standard Deviation|Mean
2556765|NCT02720081|Secondary|Change From Baseline in Heart Rate at Week 4|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 4|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 4 for the analysis endpoint, heart rate.|||beats/min||Standard Deviation|Mean
2556766|NCT02720081|Secondary|Change From Baseline in Heart Rate at Week 2|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 2|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 2 for the analysis endpoint, heart rate.|||beats/min||Standard Deviation|Mean
2556767|NCT02720081|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 6|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, diastolic blood pressure.|||mmHg||Standard Deviation|Mean
2556768|NCT02720081|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 4|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 4|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 4 for the analysis endpoint, diastolic blood pressure.|||mmHg||Standard Deviation|Mean
2556769|NCT02720081|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 2|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 2|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 2 for the analysis endpoint, diastolic blood pressure.|||mmHg||Standard Deviation|Mean
2559529|NCT02677779|Secondary|Bleeding: Proportion of Patients With Bleeding Necessitating Haemostasis|proportion of patients with bleeding necessitating haemostasis|during procedure|ITT analysis: patients with no detectable bacterial load at baseline were included.|||participants|||Number
2556772|NCT02720081|Secondary|Change From Baseline in Systolic Blood Pressure at Week 2|Baseline was defined at Week 0. If Week 0 measurement was not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 2|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 2 for the analysis endpoint, systolic blood pressure.|||mmHg||Standard Deviation|Mean
2556773|NCT02720081|Secondary|Change From Baseline in Hematocrit (%) at Week 6|Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, hematocrit (%).|||Percent||Standard Deviation|Mean
2556774|NCT02720081|Secondary|Change From Baseline in White Blood Cell Count at Week 6|Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, white blood cell count.|||10^9 cells/L||Standard Deviation|Mean
2556775|NCT02720081|Secondary|Change From Baseline in Platelet Count at Week 6|Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, platelet count.|||10^9 cells/L||Standard Deviation|Mean
2556776|NCT02720081|Secondary|Change From Baseline in Neutrophil (%) at Week 6|Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, neutrophil (%).|||Percent of White Blood Cells||Standard Deviation|Mean
2556777|NCT02720081|Secondary|Change From Baseline in Eosinophil (Percent [%]) at Week 6|Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, eosinophil (%).|||Percent of White Blood Cells||Standard Deviation|Mean
2556778|NCT02720081|Secondary|Change From Baseline in Bilirubin at Week 6|Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, bilirubin.|||mg/dL||Standard Deviation|Mean
2556779|NCT02720081|Secondary|Change From Baseline in Aspartate Aminotransferase (AST) at Week 6|Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, AST.|||IU/L||Standard Deviation|Mean
2556780|NCT02720081|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) at Week 6|Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, ALT.|||IU/L||Standard Deviation|Mean
2556781|NCT02720081|Secondary|Change From Baseline in Alkaline Phosphatase (ALP) at Week 6|Baseline was defined at Week 0. If Week 0 measurement is not available, the last non-missing value before treatment was used as Baseline.|Baseline and Week 6|Analysis population includes all participants who received at least 1 dose of study drug and had non-missing change from baseline value at Week 6 for the analysis endpoint, ALP.|||IU/L||Standard Deviation|Mean
2556782|NCT02720081|Secondary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 6 weeks|Analysis population included all randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2556783|NCT02720081|Secondary|Percentage of Participants Who Experienced an Adverse Event (AE)|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 8 weeks|Analysis population included all randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2556784|NCT02720081|Secondary|Percentage of Days With Worsening Asthma Average Over Weeks 3 to 6|"A day with worsening asthma was defined as any day during which any of the following occurred: a decrease from baseline in morning (AM) peak expiratory flow (PEF) of more than 20%; AM PEF less than 180 liters/minute (L/min); an increase in β-agonist use of more than 70% (and a minimum increase of at least 2 puffs); an increase from baseline in daytime asthma symptom score of more than 50%; overnight asthma symptom of: Awake all night; an asthma attack, as defined by any day when one or more of the following events due to asthma has occurred: corticosteroid use (systemic); unscheduled visit to the doctor or urgent care clinic; unscheduled visit to the emergency department; and/or hospitalization. Participants needed at least 80% of days with a complete diary during Weeks 3 to 6. A diary is considered complete if none of the above 6 components used to determine asthma worsening are missing."|Up to 4 weeks|Analysis population consists of randomized participants who received at least 1 dose of study drug and had at least 80% of days with a complete diary during Weeks 3 to 6 (a diary is considered complete if none of the 6 components used to determine asthma worsening are missing).|||Percentage of days||95% Confidence Interval|Least Squares Mean
2556785|NCT02720081|Primary|Baseline Pre-dose Forced Expiratory Volume in One Second (FEV1)|FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second.|Before the first dose of study investigational product (Baseline)|Analysis population consists of randomized participants who received at least 1 dose of study drug.|||Liter||Standard Deviation|Mean
2556786|NCT02719938|Secondary|Number of Participants With Burdensome Treatments|Number of participants with burdensome treatments, defined as a count of participants with any use of the following treatments: feeding tube, central intravenous line, surgical procedure, intensive care transfer, ventilator use, cardiopulmonary resuscitation use at any time during the time frame of measurement.|From time of hospital discharge up to 60 days||||Participants|||Count of Participants
2556787|NCT02719938|Secondary|Number of Palliative Care Domains in Treatment Plan|Number of palliative care domains addressed in treatment plan, using the Palliative Care Domain score which is scored 0 (not addressed) or 1 (addressed) for each of 10 possible domains of a palliative care treatment plan -- prognosis, overall goals of care, physical symptoms, psychiatric symptoms, spiritual needs, and 5 treatment preferences: resuscitation, artificial feeding, intravenous fluids, antibiotics, and hospitalization. Scores are summed for a total possible score of 0-10, with higher scores indicating greater attention to palliative care needs in the treatment plan.|From time of hospital discharge up to 60 days||||units on a scale||Standard Deviation|Mean
2556788|NCT02719938|Secondary|Percent of Participants With Physician Orders for Life Sustaining Treatment (POLST)|Percent of participants with POLST (Physician Orders for Life Sustaining Treatment) form completed and signed|From time of hospital discharge up to 60 days||||percentage of participants|||Number
2556789|NCT02719938|Secondary|Percent of Participants With Referral to Hospice or Outpatient Palliative Care From Discharge to 60 Days Follow-Up|Percent of patients with referral to hospice or outpatient palliative care from discharge to 60 days follow-up from family interviews.|From time of hospital discharge up to 60 days||||percentage of patients|||Number
2556790|NCT02719938|Secondary|Caregiver Strain|Family Distress in Advanced Dementia instrument, a 21 item questionnaire designed to detect strain in family caregivers in dementia. Caregivers are asked a series of items about emotional distress, preparedness, and relations with healthcare providers scored 1-5, with higher scores indicting greater distress.|Interview at 60 days after hospitalization||||score on a scale||Standard Deviation|Mean
2556791|NCT02719938|Secondary|Patient Comfort End of Life in Dementia (CAD-EOLD)|Comfort at the End of Life in Dementia (CAD-EOLD) instrument, consisting of 14 Likert-scaled items measuring comfort in the final phase of life with dementia. Scores range from 14-42, with higher scores indicting greater comfort.|60 days||||score on a scale||Standard Deviation|Mean
2556792|NCT02719938|Primary|Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days)|Includes emergency department visits and hospital admissions during measure interval|From time of hospital discharge up to 60 days||||events per day|||Number
2556793|NCT02719743|Secondary|Number of Subjects Reporting Adverse Events of Special Interest (AESI)|AESI are a subset of adverse events defined in the Committee for Medicinal Products for Human Use (CHMP) Risk Management Plan for Pandemic Vaccines for safety monitoring.|During the entire study period (Day 0 to Day 415 approximately)|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2556794|NCT02719743|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 to Day 415 approximately)|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2556795|NCT02719743|Secondary|Number of Subjects Reporting Potential Immune Mediated Diseases (pIMDs)|"Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any pIMD = at least one pIMD experienced by the study subject. Related = pIMD assessed by the investigator to be causally related to the study vaccination."|During the entire study period (Day 0 to Day 415 approximately)|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2556796|NCT02719743|Secondary|Number of Subjects Reporting Medically Attended Events (MAEs)|MAEs are adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as at least 1 MAE experienced.|During the entire study period (Day 0 to Day 415 approximately)|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2556797|NCT02719743|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevents normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Day 385-Day 415) follow-up period after vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2556798|NCT02719743|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination.|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevents normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 21-day follow-up period (Day 0-Day 20) after each vaccine dose|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2556800|NCT02719743|Secondary|Number of Subjects Reporting Solicited General Symptoms.|Assessed solicited general symptoms were fever (defined as temperature ≥ 38.0 degrees Celsius (°C) assessed by any route (oral, axillary, rectal)], irritability/fussiness, drowsiness and. loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 irritability/Fussiness and Drowsiness = Prevented normal activity, Grade3 Loss of appetite = Did not eat at all. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination|During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2556801|NCT02719743|Secondary|Duration of Solicited Local Symptoms|Duration was defined as number of days with any grade of local symptoms.|During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose|Analysis was performed on the Total Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.cohort which included all vaccinated subjects for whom data were available.|||Days||Inter-Quartile Range|Median
2556802|NCT02719743|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local AEs assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb is moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2556803|NCT02719743|Secondary|Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen.|Antigen-specific CD4+/CD8+ T Cells identified as CD4/CD8+ were analysed for T cells expressing two or more of the following immune markers: CD40 Ligand, Interleukin (IL)-2, Tumor Necrosis Factor alpha (TNF-a), Interferon-gamma (IFN-g). The frequency was presented as number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells repsectively. All doubles = T cell expressing at least 2 cytokines.|At Days 0, 42, 385 and 392|Analysis was performed on the Total Vaccinated cohort (CMI sub-cohort) which included all vaccinated subjects for whom data were available. The CMI sub-cohort included approximately 20 vaccinated subjects per group.|||cells/million T cells||Inter-Quartile Range|Median
2556804|NCT02719743|Secondary|Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains.|VRR for MN was defined as the incidence rate of subjects with at least a 4-fold increase in post vaccination reciprocal titer relative to pre vaccination titers. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).|At Day 42, Day 385 (relative to Day 0), Day 392 (relative to Day 0) and D 392 (relative to Day 385)|Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).|||Participants|||Count of Participants
2556805|NCT02719743|Secondary|Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens|MN antibody titers were expressed as Geometric Mean Titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).|At Days 0, 42, 385 and Day 392|Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).|||Titers||95% Confidence Interval|Geometric Mean
2556806|NCT02719743|Secondary|Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains.|MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 385) reciprocal MN titer to the pre-vaccination (Day 0) reciprocal MN titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).|At Day 385 (relative to Day 0)|Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).|||Fold change||95% Confidence Interval|Geometric Mean
2556807|NCT02719743|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains|MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 42) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).|At Day 42 (relative to Day 0), at Day 385 (relative to Day 0) and at Day 392 (relative to Day 0)|Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).|||Fold change||95% Confidence Interval|Geometric Mean
2556815|NCT02719743|Primary|Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination|The MN antibody titres were expressed in terms of immunogenicity indices for each group. Immunogenicity index (DGMT) = If the LL of the 95% CI for GMT group ratio is less than 0.25 then DGMT =0. If the LL of the 95% CI for GMT group ratio is greater than 1 then DGMT =1.|At Day 42|Analysis was performed on cohort for analysis of the immunogenicity-fever score which included all subjects who have received all study vaccine dose(s) at Day 42 for whom temperature measurements are available during the first 3 days after both vaccine doses 1 & 2 and with pre & post immune result of antibody of interest.|||Immunogenicity Index||Full Range|Mean
2556808|NCT02719743|Secondary|Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens|GMTs were defined as the geometric mean antibody titres calculated on all subjects post the primary immunization (at Day 0, 42, 385) and 7 days post booster dose (at Day 392). The aggregate variables were calculated for each group. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).|At Days 0, 42 and 385 (post the primary immunization), at Day 392 (7 days post booster dose)|Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster).|||Titers||95% Confidence Interval|Geometric Mean
2556809|NCT02719743|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.|Seroprotection rate (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers ≥ 40 against the tested vaccine virus The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).|At Days 0, 42, 385, 392|Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster)|||Participants|||Count of Participants
2556810|NCT02719743|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.|Seroconversion rate (SCR) was defined as the proportion of subjects who have either a pre-vaccination reciprocal HI titer less than (<) 10 and a post-vaccination reciprocal titer greater than or equal to (≥) 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).|At Days 42, 385 and 392|Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster)|||Participants|||Count of Participants
2556811|NCT02719743|Primary|Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains.|MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 392) reciprocal MN titer to the pre-vaccination (Day 385) reciprocal MN titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).|At Day 392 (relative to Day 385) post booster vaccination|Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster)|||Fold change||95% Confidence Interval|Geometric Mean
2556812|NCT02719743|Primary|Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains.|MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer (Day 392) to the pre-vaccination (Day 385) reciprocal HI titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).|At Day 392 (relative to Day 385) post booster vaccination|Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster)|||Fold change||95% Confidence Interval|Geometric Mean
2556813|NCT02719743|Primary|Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination.|Fever index was defined as the average temperature for each vaccine group. Fever index (DR)= The average temperature measurement for each vaccine group. Fever index from Days 0-2 after each dose Any temperature < 38°C (100.4 F) was assigned a value of 0. Any temperature > 40.5°C was assigned a value of 40.5. DR correspond to 243 minus the sum of recorded temperature values for 3 days after (dose 1 and dose 2)/243.|During the 3-day follow-up period (i.e. on the day of vaccination and 2 subsequent days) after Dose 1 and Dose 2.|Analysis was performed on cohort for analysis of the immunogenicity-fever score which included all subjects who have received all study vaccine dose(s) at Day 42 for whom temperature measurements are available during the first 3 days after both vaccine doses 1 and 2.|||Degrees Celsius||Full Range|Mean
2556814|NCT02719743|Primary|Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination.|Fever index was defined as the average temperature for each vaccine group. Fever index (DR) = The average temperature measurement for each vaccine group. Fever index from Days 0-2 after each dose Any temperature < 38°C (100.4 F) was assigned a value of 0. Any temperature > 40.5°C was assigned a value of 40.5. DR correspond to 243 minus the sum of recorded temperature values for 3 days after (dose 1 and dose 2)/243.|During the 3-day follow-up period (i.e. on the day of vaccination and 2 subsequent days) after Dose 1 and Dose 2.|Analysis was performed on cohort for analysis of the immunogenicity-fever score which included all subjects who have received all study vaccine dose(s) at Day 42 for whom temperature measurements are available during the first 3 days after both vaccine doses 1 and 2.|||Degrees Celsius||Full Range|Mean
2556926|NCT02718118|Primary|Proportion of Composite Responders Who Achieve at Least a 1-point Reduction From Baseline in Glabellar Line Severity Score (GLSS) at Maximum Frown.|Proportion of composite responders who achieve at least a 1-point reduction from baseline in glabellar line severity score (GLSS) based on subject and blinded-evaluator assessment of glabellar line severity at maximum frown on Day 30.|30 days||||Participants|||Count of Participants
2556816|NCT02719743|Primary|Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination|The HI antibody titres were expressed in terms of immunogenicity indices for each group. Immunogenicity index (DGMT) = If the LL of the 95% CI for GMT group ratio is less than 0.25 then DGMT =0. If the LL of the 95% CI for GMT group ratio is greater than 1 then DGMT =1.|At Day 42|Analysis was performed on cohort for analysis of the immunogenicity-fever score which included all subjects who have received all study vaccine dose(s) at Day 42 for whom temperature measurements are available during the first 3 days after both vaccine doses 1 and 2.|||Immunogenicity Index||Full Range|Mean
2556817|NCT02719639|Secondary|Patient's Satisfaction With Handling Inhalation Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)|At visit 2 patients were asked how satisfied they were with handling the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases.|Approximately 6 weeks|Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set.|||Participants|||Number
2556818|NCT02719639|Secondary|Patient's Satisfaction With Inhaling From Device Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)|At visit 2 patients were asked how satisfied they were with inhaling from the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases.|Approximately 6 weeks|Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set.|||Participants|||Number
2556819|NCT02719639|Secondary|Patient's Overall Satisfaction With Treatment Spiolto® Respimat® at Visit 2 (Approximately 6 Weeks)|At visit 2 patients were asked for their overall satisfaction with the Spiolto® Respimat® device. The patients were given range of responses from very satisfied to very dissatisfied and responses were recorded including unanswered cases.|Approximately 6 weeks|Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set.|||Participants|||Number
2556820|NCT02719639|Secondary|General Condition of the Patients Evaluated by the Physician, (Physician's Global Evaluation (PGE) Score) at Baseline (visit1) and Approximately 6 Weeks (visit2).|"This outcome measures general condition of the patient evaluated by the physician (PGE score) at visit 1 (baseline visit at the start of the study) and visit 2 (final visit approximately 6 weeks after visit 1) evaluated on an 8-point scale with the scores Poor (1,2), Satisfactory (3, 4), Good (5, 6) and Excellent (7, 8). More the score, the better is the general condition of patient."|Baseline and week 6|Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set.|||Participants|||Number
2556821|NCT02719639|Secondary|Change in the Physical Functioning (PF-10) Score From Baseline (visit1) to Approximately 6 Weeks (visit2)|"Change in PF-10 score was determined by taking into account the individual change of each patient between visit 1 and visit 2. The PF-10 used for assessing the primary outcome is a sub-domain of the validated Short Form (SF)-36 quality of life questionnaire and consists of 10 questions evaluating the experienced restrictions while conducting usual activities. Each question of the PF-10 may be answered with yes, limited a lot, yes, limited a little, or No, not limited at all, with a score of 1, 2, or 3, respectively. The scores will be summed up between 10 and 30. The final sum of the individual scores was standardized to a range of 0 to 100 using the formula: 100*(sum-10)/20. The lower the score the more disability. The higher the score the less disability. If less than half of the scale items were missing, missing values were replaced with the mean of the other values. If half or more than half was missing, no score was calculated."|Baseline and week 6|Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set.|||Score on scale||Standard Deviation|Mean
2556822|NCT02719639|Primary|Percentage of Patients With Therapeutic Success After Approximately 6 Weeks.|The therapeutic success was defined as a minimum of 10- point increase in the Physical Functioning (PF-10) score between visit 1 (baseline visit at the start of the study) and visit 2 (final visit approximately 6 weeks after visit 1), having approximately time period of 6 weeks between the evaluated questionnaires. PF-10 score measures changes in physical functioning - serving as a surrogate for physical activity and exercise capacity - in COPD patients.|Approximately 6 weeks|Full analysis set (FAS): All patients who received treatment with Spiolto® Respimat® and had visits 1 and 2 documented as well as filled in all questionnaires were included in the full analysis set.|||Percentage of participants (%)||95% Confidence Interval|Number
2556823|NCT02719535|Secondary|Change of Tangent Modulus From Baseline at 6 Months|Tangent modulus: in MPa Corneal parameters usually will stabilize in 1 month, this study will monitor it till 6 months.|At baseline, then change from baseline to 6 months||||MPa||Standard Deviation|Mean
2556824|NCT02719535|Primary|Change of Corneal Stiffness From Baseline at 6 Months|Corneal Stiffness: in N/mm Corneal parameters usually will stabilize in 1 month, this study will monitor it till 6 months.|At baseline, then change from baseline to 6 months||||N/mm||Standard Deviation|Mean
2556825|NCT02719171|Secondary|Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. The percentage of participants achieving PASI90 at Week 16 are provided. NRI was used for missing data.|Week 16|FAS|||percentage of participants||90% Confidence Interval|Number
2557100|NCT02714504|Primary|Proportion of Patients Who Develop Invasive Fusariosis Until Neutrophil Recovery|Proportion of patients who develop invasive fusariosis until neutrophil recovery, for an average of 4 weeks|Until neutrophil recovery, for an average of 4 weeks||||Participants|||Count of Participants
2556826|NCT02719171|Secondary|Modified Nail Psoriasis Severity Index (mNAPSI): Change From Baseline to Week 16|mNAPSI grades each fingernail for onycholysis (separation of the nail plate from the nail bed) and oil-drop (salmon patch) dyschromia (reddish-brown discoloration under the nail plate) on a scale of 0 (none present) to 3 (>30% of the nail); pitting (small, sharply defined depressions in the nail surface) on a scale of 0 (0 pits present) to 3 (>50 pits present); nail plate crumbling on a scale of 0 (no crumbling) to 3 (>50% of nail has crumbling); and presence (1) or absence (0) of leukonychia (white spots), splinter hemorrhages, nail bed hyperkeratosis, and red spots in the lunula. mNAPSI is calculated as the sum of all the components for all of the participants fingernails, for a minimal - maximal total score of 0 to 130. A negative change from Baseline indicates improvement.|Baseline, Week 16|Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.|||units on a scale||90% Confidence Interval|Least Squares Mean
2556827|NCT02719171|Secondary|Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Change From Baseline to Week 16 in Participants With Enthesitis at Baseline|Assessment of enthesitis was performed in the following 16 domains: left and right (L/R) medial epicondyle; L/R lateral epicondyle; L/R supraspinatus insertion into the greater tuberosity of humerus; L/R greater trochanter; L/R quadriceps insertion into superior border of patella; L/R patellar ligament insertion into inferior pole of patella or tibial tubercle; L/R Achilles tendon insertion into calcaneum; L/R plantar fascia insertion into calcaneum. Tenderness at each site was classified as either absent (0) or present (1) to yield total SPARCC scores ranging from 0 (0 sites with tenderness) to 16 (16 sites with tenderness). A negative change from Baseline indicates improvement.|Baseline, Week 16|Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.|||units on a scale||90% Confidence Interval|Least Squares Mean
2556828|NCT02719171|Secondary|Dactylitis Count: Change From Baseline to Week 16 in Participants With Dactylitis at Baseline|The number of fingers and toes with dactylitis (ranging from 0 to 20). A negative change represents a decrease in the number of fingers and toes affected by dactylitis.|Baseline, Week 16|Participants in the FAS with available data at Baseline and Week 16.|||fingers and toes with dactylitis||90% Confidence Interval|Least Squares Mean
2556829|NCT02719171|Secondary|SF-36 Mental Component: Change From Baseline to Week 16|The SF-36 determined participant's overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.|Baseline, Week 16|Participants in the FAS with available data at Baseline and Week 16.|||units on a scale||90% Confidence Interval|Least Squares Mean
2556830|NCT02719171|Secondary|Short Form-36 Health Status Survey (SF-36) Physical Component: Change From Baseline to Week 16|The SF-36 determined participant's overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.|Baseline, Week 16|Participants in the FAS with available data at Baseline and Week 16.|||units on a scale||90% Confidence Interval|Least Squares Mean
2556831|NCT02719171|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) Score: Change From Baseline to Week 16|The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of < 0.5. A negative change from Baseline indicates improvement.|Baseline, Week 16|Participants in the FAS with available data at Baseline and Week 16.|||units on a scale||90% Confidence Interval|Least Squares Mean
2556832|NCT02719171|Secondary|Swollen Joint Count (SJC): Change From Baseline to Week 16|Sixty-six joints were assessed and classified as either swollen (1) or not swollen (0). A negative change represents a decrease in the number of tender joints.|Baseline, Week 16|Participants in the FAS with available data at Baseline and Week 16.|||swollen joints||90% Confidence Interval|Least Squares Mean
2556833|NCT02719171|Secondary|Tender Joint Count (TJC68): Change From Baseline to Week 16|Sixty-eight joints were assessed and classified as either tender (1) or not tender (0). A negative change represents a decrease in the number of tender joints.|Baseline, Week 16|Participants in the FAS with available data at Baseline and Week 16.|||tender joints||90% Confidence Interval|Least Squares Mean
2556834|NCT02719171|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 16|"Response defined by ACR70 criteria (improvement from baseline) at Week 16: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters:~Patient assessment of pain~Patient global assessment of disease activity~Investigator's global assessment of disease activity~HAQ-DI~Acute phase reactant value (C-reactive protein).~NRI was used for missing data."|Week 16|FAS|||percentage of participants||90% Confidence Interval|Number
2556835|NCT02719171|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 16|"Response defined by ACR50 criteria (improvement from baseline) at Week 16: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters:~Patient assessment of pain~Patient global assessment of disease activity~Investigator's global assessment of disease activity~HAQ-DI~Acute phase reactant value (C-reactive protein).~NRI was used for missing data."|Week 16|FAS|||percentage of participants||90% Confidence Interval|Number
2557116|NCT02714283|Secondary|Opportunistic Infections|Opportunistic infections.|up to 8 years||||Events|Patient-years||Number
2557117|NCT02714283|Secondary|Hip Fracture|Hip fracture.|up to 8 years||||Events|Patient-years||Number
2556836|NCT02719171|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 16|"Response defined by ACR20 criteria (improvement from baseline) at Week 16: ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters:~Patient assessment of pain~Patient global assessment of disease activity~Investigator's global assessment of disease activity~Health Assessment Questionnaire Disability Index (HAQ-DI)~Acute phase reactant value (C-reactive protein).~Nonresponder imputation (NRI) was used for missing data."|Week 16|FAS|||percentage of participants||90% Confidence Interval|Number
2556837|NCT02719028|Secondary|Fatty Liver|To evaluate the recover fatty liver effect of Antroquinonol on patients who with fatty liver by Investigator|12 weeks|Only Per-protocol population subjects with abnormal liver attenuation at baseline subjected to follow-up after 12 weeks|||Participants|||Count of Participants
2556838|NCT02719028|Secondary|Non-invasive Arterial Stiffness Measurement|To evaluate the effect of Antroquinonol via a non-invasive arterial stiffness measurement.|12 weeks|Per-protocol population|||percentage of change||Standard Deviation|Mean
2556839|NCT02719028|Secondary|LDL& HDL (mg/dL)|value at 12 weeks minus value at baseline of PP pupulation in HDL/LDL ratio.|12 weeks||||percentage of change||Standard Deviation|Mean
2556840|NCT02719028|Primary|TG Change (mg/dL )|value at 12 weeks minus value at baseline|12 weeks|Per-protocol population|||percentage of change||95% Confidence Interval|Median
2556841|NCT02718898|Secondary|Number of Participants Achieving sPGA of Genitalia (0,1) at Week 12 by Treatment-Emergent Anti-Drug Antibody (TE-ADA) Status and by Neutralizing Antibody (NAb) Status|"sPGA of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis was assessed as follows: 0 = clear,1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.~sPGA of Genitalia (0,1) : A sPGA of Genitalia assessed as either 0 or 1."|Week 12|All randomized participants who received at least one dose of study drug and either had baseline and at least 1 post-baseline evaluable samples or had no evaluable baseline and all negative post-baseline anti-drug antibody negative samples.|||Participants|||Count of Participants
2556842|NCT02718898|Secondary|Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items|GPSS is a participant's-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent was asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an Numeric Rating Scale (NRS) of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, where 0 (no severity) and 10 (worst imaginable severity). total score ranges from 0 (no severity) - 80 (worst imaginable severity) LS Mean was calculated using MMRM model with treatment, baseline BSA category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects.|Baseline, Week 12|All randomized participants with baseline and post baseline observation for GPSS total or individual item scores.|||units on a scale||Standard Error|Least Squares Mean
2556843|NCT02718898|Secondary|Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS)|"SF-36 is a participant-reported outcome measure evaluating a participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the MCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.~Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, baseline BSA category, & baseline value and modified baseline observation carried forward (mBOCF) imputation method."|Baseline, Week 12|"All randomized participants with baseline and post baseline measurement for SF-36 MCS.~mBOCF: Participants with or without post baseline measurement who discontinued treatment due to Adverse Event (AE) or death were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||Standard Error|Least Squares Mean
2556844|NCT02718898|Secondary|Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)|"SF-36 is a participant-reported outcome measure evaluating a participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.~Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, baseline BSA category, & baseline value and modified baseline observation carried forward (mBOCF) imputation method."|Baseline, Week 12|"All randomized participants with baseline and post baseline measurement for SF-36 PCS.~mBOCF: Participants with or without post baseline measurement who discontinued treatment due to Adverse Event (AE) or death were imputed by their baseline observation , Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||Standard Error|Least Squares Mean
2556845|NCT02718898|Secondary|Number of Participants With at Least a 2-Point Change in Patient's Global Assessment of Genital Psoriasis (PatGA-Genital)|"Patient's Global Assessment of Genital Psoriasis (PatGA-Genital) is a participant-administered, single-item scale on which participants are asked to rank the severity of their genital psoriasis today by circling a number on a 0 to 5 NRS, as follows: from 0 (clear), no genital psoriasis; to 5 (severe)."|Week 12|All randomized participants with baseline PatGA-Genital score >= 2.|||Participants|||Count of Participants
2556846|NCT02718898|Secondary|Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score|mGPASI determines participants psoriasis severity in the genital region at a given time point yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. scoring index incorporates the degree of erythema (or redness), induration (or thickness), and scaling) of the genital plaques as well as erosion, fissure, and/or ulcer as a product of the genital area involved. LS Mean was calculated using MMRM model with treatment, baseline BSA category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects.|Baseline, Week 12|All randomized participants with baseline and post baseline observation for mGPASI.|||units on a scale||Standard Error|Least Squares Mean
2557118|NCT02714283|Secondary|Sensorineural Hearing Loss|Sensorineural hearing loss.|up to 8 years||||Events|Patient-years||Number
2556847|NCT02718898|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score|"DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: 1) Symptoms and feelings 2) Daily activities 3) Leisure 4) Work and school 5) Personal relationships 6) Treatment.~Response categories include:~0 = not at all; 1 = a little; 2 = a lot; 3 = very much; not relevant responses scored as 0 and total score range of 0 to 30; higher scores indicate poor quality of life.~Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, baseline body surface area (BSA) category, baseline value, visit, treatment-by-visit, and baseline value-by-visit interactions as fixed effects."|Baseline, Week 12|All randomized participants with baseline and post baseline observation for DLQI.|||units on a scale||Standard Error|Least Squares Mean
2556848|NCT02718898|Secondary|Number of Participants Whose Frequency of Avoiding Sexual Activity is Either Never or Rarely Limited by Genital Psoriasis in the Sexual Activity Avoidance Subscale Score of the Genital Psoriasis Sexual Impact Scale (GPSIS)|"GPSIS is a participant reported outcome measure to evaluate the impact of genital psoriasis symptoms on sexual activity.~The GPSIS Sexual Activity Avoidance Subscale includes 2 items:~Item 1 asks whether the participant has been sexually active in the past week. (No due to other reasons = 1, No due to genital Ps = 5) Item 2 asks how often the participant avoided sexual activity in the past week due to Genital Psoriasis. (Never = 1, rarely = 2, Sometimes = 3, Often = 4)"|Week 12|All randomized participants with baseline GPSIS sexual activity avoidance subscale score >= 3.|||Participants|||Count of Participants
2556849|NCT02718898|Secondary|Number of Participants Whose Frequency of Sexual Activity is Never or Rarely Limited by Genital Psoriasis, Utilizing the Genital Psoriasis Sexual Frequency Questionnaire (SFQ) Item 2|"The SFQ is a participant reported outcome measure to evaluate the impact of genital psoriasis symptoms on sexual frequency. It consists of 2 items that assess the impact of genital psoriasis symptoms on the frequency of sexual activity. Respondents were asked to answer the questions based on their psoriasis symptoms in the genital area. Item 2 assesses how often genital psoriasis symptoms limited the frequency of sexual activity with the following response options: 0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always.~*The SFQ is also referred to as the GenPs-SFQ (genital psoriasis sexual frequency questionnaire)."|Week 12|All randomized participants with baseline GenPs-SFQ Item 2 Score >= 2.|||Participants|||Count of Participants
2556850|NCT02718898|Secondary|Number of Participants With at Least a 3 Point Improvement in Genital Psoriasis Itch Numeric Rating Scale (NRS) Item Within the Genital Psoriasis Symptom Scale (GPSS)|GPSS is a participant-administered assessment of 8 symptoms: itch, pain, discomfort, stinging, burning, redness, scaling, and cracking. Each respondent was asked to answer the questions based on the psoriasis symptoms in his or her genital area. The overall severity for each individual genital psoriasis symptom is indicated by selecting the number from an Numeric Rating Scale (NRS) of 0 to 10 that best describes the worst level of each symptom in the genital area in the past 24 hours, where 0 (= no severity) and 10 (worst imaginable severity).|Week 12|All randomized participants with baseline GPSS Itch NRS Score >= 3.|||Participants|||Count of Participants
2556851|NCT02718898|Secondary|Number of Participants Achieving Overall sPGA (0,1)|"The overall sPGA is the physician's global assessment of the participant's psoriasis (Ps) lesions at a given time point. Plaques were assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity was given using the anchors of 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.~Overall sPGA (0,1) : An overall sPGA assessed as either 0 or 1."|Week 12|All randomized participants.|||Participants|||Count of Participants
2556852|NCT02718898|Primary|Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1)|"sPGA of Genitalia score is based on a combination of erythema and the secondary features (plaque elevation and/or scale). For the analysis of responses, the participant's psoriasis was assessed as follows: 0 = clear,1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.~sPGA of Genitalia (0,1) : A sPGA of Genitalia assessed as either 0 or 1."|Week 12|All randomized participants.|||Participants|||Count of Participants
2556853|NCT02718625|Secondary|Wound Bed Sore (WBS) Score|For purposes of this secondary analysis, changes in wound status were to be measured by using the Wound Bed Sore (WBS) score. At Visits 1 and 7, eight individual wound bed sore characteristics were scored, each on a scale of 0 to 2 (higher scores represented better outcomes), and then summed to derive the total WBS score (ranging from 0 to 16). The reduction in total WBS scores were calculated as: (Total WBS Score at Visit 1 - Total WBS Score at Visit 7/Exit).|6 weeks|Due to early study termination by Sponsor, only one subject completed the study and underwent Visit 7/Exit assessments (in the Santyl group). No analyses were done and individual data are presented for the single completed subject.|||score on a scale|||Number
2556854|NCT02718625|Secondary|Pressure Ulcer Scale for Healing (PUSH) Score|For purposes of this secondary analysis, changes in wound status were to be measured by using the Pressure Ulcer Scale for Healing (PUSH) Tool. At Visits 1 and 7, the target ulcer was to be scored based on length/width (from 0 cm^2 to >24 cm^2 on a scale of 1 to 10), exudate amount (from 'none' to 'heavy' on a scale of 0 to 3) , and tissue type ('closed' to 'necrotic tissue' on a scale of 0 to 4); from which a total PUSH score from the sum of scores for the three categories could be derived (ranging from 0 to 17). Higher scores indicated a worse response. The reduction in PUSH individual sub-scores and total PUSH scores were calculated as: (PUSH Score at Visit 1 - Push Score at Visit 7/Exit).|6 weeks|Due to early study termination by Sponsor, only one subject completed the study and underwent Visit 7/Exit assessments (in the Santyl group). Ulcer area measurements and scoring by independent reviewers did not occur; no PUSH length/width score was determined. No analyses were done and individual data are presented for the single completed subject.|||score on a scale|||Number
2556855|NCT02718625|Secondary|Percentage Reduction in Ulcer Area|For purposes of this secondary analysis, the percentage reduction in ulcer area was to be measured during ulcer photograph review by two independent reviewers, using the ImageIQ EDCIQ mobile imaging system, with the reduction calculated as: ([ulcer area at Visit 1 - ulcer area at Visit 7 / ulcer area at Visit 1] x 100).|6 weeks|Due to early study termination by Sponsor, the independent reviewers' assessment of ulcer photographs did not take place; thus, the analysis of this secondary outcome was not possible.||||||
2556942|NCT02717754|Secondary|Half-Life (t1/2) of Oseltamivir and RO0640802|t1/2 is the time measured for the plasma concentration to decrease by one half. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.|||hour||Standard Deviation|Mean
2556856|NCT02718625|Secondary|Percentage Reduction in Non-viable Tissue|For purposes of this secondary analysis, the assessment of percentage of non-viable necrotic tissue was to be assessed based on photograph review by two independent reviewers, with the reduction calculated as: percentage of non-viable necrotic tissue at Visit 1 - percentage of non-viable necrotic tissue at Visit 7.|6 weeks|Due to early study termination by Sponsor, the assessment of ulcer photographs by two independent reviewers did not take place; thus, the analysis of this secondary outcome was not possible.||||||
2556857|NCT02718625|Secondary|Time in Days to Complete Debridement|For purposes of this secondary analysis, the time (in days) to achieve complete debridement (as defined in the primary analysis) was to be calculated from the date of randomization visit to the date of which the subject's ulcer was deemed to have achieved complete debridement.|6 weeks|Due to early study termination by Sponsor, complete debridement assessment by independent review of ulcer photographs did not take place and time (in days) to complete debridement was not calculated.||||||
2556858|NCT02718625|Primary|Proportion of Ulcers With Complete Debridement|For purposes of the primary analysis, the status of complete debridement was to be assessed from photographs by two independent reviewers.|6 weeks|Due to early study termination by Sponsor, complete debridement assessment by independent review of ulcer photographs did not take place.||||||
2556859|NCT02718417|Secondary|Number of Participants With Presence or Absence of Predictive Candidate Biomarkers in Tumor Tissue as Assessed by Immunohistochemistry (IHC)|Data for this outcome measure will be reported at the time of last subject last visit result posting (May 2020).|pre-dose and at multiple time points up to 3 years||2020-05-31|05/2020||||
2556860|NCT02718417|Secondary|Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb) Response|Data for this outcome measure will be reported at the time of last subject last visit result posting (May 2020).|pre-dose and at multiple time points up to 3 years||2020-05-31|05/2020||||
2556861|NCT02718417|Secondary|Chemotherapy Phase: Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose AUC(0-24) of Carboplatin|Data for this outcome measure will be reported at the time of last subject last visit result posting (May 2020).|pre-dose and at multiple time points up to 3 years||2020-05-31|05/2020||||
2556862|NCT02718417|Secondary|Chemotherapy Phase: Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose AUC(0-24) of Paclitaxel|Data for this outcome measure will be reported at the time of last subject last visit result posting (May 2020).|pre-dose and at multiple time points up to 3 years||2020-05-31|05/2020||||
2556863|NCT02718417|Secondary|Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Carboplatin|Data for this outcome measure will be reported at the time of last subject last visit result posting (May 2020).|pre-dose and at multiple time points up to 3 years||2020-05-31|05/2020||||
2556864|NCT02718417|Secondary|Chemotherapy Phase: Maximum Plasma Concentration (Cmax) of Paclitaxel|Data for this outcome measure will be reported at the time of last subject last visit result posting (May 2020).|pre-dose and at multiple time points up to 3 years||2020-05-31|05/2020||||
2556865|NCT02718417|Secondary|Maximum Plasma Concentration (Cmax) of Avelumab at End of Infusion|Data for this outcome measure will be reported at the time of last subject last visit result posting (May 2020).|pre-dose and at multiple time points up to 3 years||2020-05-31|05/2020||||
2556866|NCT02718417|Secondary|Chemotherapy Phase: Predose Total Plasma Concentration (Ctrough) of Carboplatin|Data for this outcome measure will be reported at the time of last subject last visit result posting (May 2020).|pre-dose and at multiple time points up to 3 years||2020-05-31|05/2020||||
2556867|NCT02718417|Secondary|Predose Plasma Concentration (Ctrough) of Avelumab|Data for this outcome measure will be reported at the time of last subject last visit result posting (May 2020).|pre-dose and at multiple time points up to 3 years||2020-05-31|05/2020||||
2556868|NCT02718417|Secondary|European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Score|EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). In VAS, participants rated their overall health status from 0 (worst imaginable) to 100 (best imaginable). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Published weights are available that allow for the creation of a single summary score. 57 overall scores ranged from 0 to 1, with low scores representing a higher level of dysfunction.|Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)|The trial was terminated due to crossing of futility boundaries for both experimental arms as compared to the control arm at the pre-specified interim analysis for PFS based on BICR assessment. Subsequently, the data for this outcome measure was not collected and analyzed.||||||
2556869|NCT02718417|Secondary|Functional Assessment of Ovarian Symptom Index- 18 (FOSI-18) Score|Data for this outcome measure will be reported at the time of last subject last visit result posting (May 2020).|Baseline up to 3 years||2020-05-31|05/2020||||
2556870|NCT02718417|Secondary|Number of Participants With Electrocardiogram (ECG) Abnormalities|ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (>) 30 millisecond (ms) or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR) : absolute value <=50 bpm and decrease from baseline >=20 bpm; absolute value >=120 beats per minute (bpm) and increase from baseline >=20 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS interval: absolute value >= 120 ms.|Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)|The safety analysis set included all participants who had received at least one dose of study drug. Here “Overall number of participants analyzed” signifies participants who were evaluable for this outcome measure and ‘Number analyzed’ = participants in the safety analysis set who had at least one baseline and post-baseline ECG assessment.|||Participants|||Count of Participants
2556905|NCT02718248|Secondary|Physical Role Limitations|Physical Role Limitations was measured using the Physical Role Limitations subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Physical Role Limitations Subscale is scored using a range of 0-100, with a higher score indicating fewer role limitations due to physical health difficulties.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
2556871|NCT02718417|Secondary|Change From Baseline in Vital Signs - Pulse Rate at Day 1 of Cycles 2, 3, 4 in Chemotherapy Phase; Days 1, 15 and 29 of Cycles 1 and 2 in Maintenance Phase and at End of Treatment|Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized.|Baseline, first 3 months of Chemotherapy Phase (CP): Day 1 of Cycles 2, 3 and 4 (each cycle 21 days); Maintenance Phase (MP): Days 1, 15 and 29 of Cycles 1 and 2 (each cycle 42 days) and at end of treatment (up to 27 months)|The safety analysis set included all participants who had received at least one dose of study drug. Here “Overall number of participants analyzed” signifies participants who were evaluable for this outcome measure and ‘Number analyzed’ = participants evaluable for this outcome measure at specified rows.|||beats per minute||Standard Deviation|Mean
2556872|NCT02718417|Secondary|Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycles 2, 3, 4 in Chemotherapy Phase; Days 1, 15 and 29 of Cycles 1 and 2 in Maintenance Phase and at End of Treatment|Vital signs included blood pressure and pulse rate. Blood pressure included sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP).|Baseline, first 3 months of Chemotherapy Phase (CP): Day 1 of Cycles 2, 3 and 4 (each cycle 21 days); Maintenance Phase (MP): Days 1, 15 and 29 of Cycles 1 and 2 (each cycle 42 days) and at end of treatment (up to 27 months)|The safety analysis set included all participants who had received at least one dose of study drug. Here “Overall number of participants analyzed” signifies participants who were evaluable for this outcome measure and ‘Number analyzed’ = participants evaluable for this outcome measure at specified rows.|||millimeters of mercury||Standard Deviation|Mean
2556873|NCT02718417|Secondary|Number of Participants With Laboratory Abnormalities Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03|As per NCI-CTCAE v 4.03, Grade 3 and above criteria were; Hematology [Anemia - Grade 3: hemoglobin <8.0 grams per deciliter (g/dL), <4.9 millimoles per liter (mmol/L), <80 grams per liter (g/L), transfusion indicated, Grade 4: life-threatening consequences, urgent intervention indicated, Grade 5: death; platelet count decreased- Grade 3:<50.0 to 25.0*10^9/Liters(L), Grade 4: <25.0*10^9/L; lymphocyte count decreased-Grade 3: <0.5-0.2*10^9/L, Grade 4: <0.2*10^9/L; neutrophil count decreased-Grade 3: <1.0 to 0.5*10^9 /L, Grade 4: <0.5*10^9/L]. Chemistry [creatinine increased-Grade 3: >3.0 to 6.0*upper limit of normal (ULN), Grade 4: >6.0*ULN; serum amylase increased, lipase increased-Grade 3: >2.0 - 5.0*ULN, Grade 4: >5.0*ULN]. Liver function [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)-Grade 3: >5.0 to 20.0*ULN, Grade 4: >20.0*ULN].|Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)|The safety analysis set included all participants who received at least one dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for each specified row.|||Participants|||Count of Participants
2556874|NCT02718417|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) Graded Based on, National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Treatment-emergent events are events between first dose of study drug and up to 27 months that were absent before treatment or that worsened relative to pretreatment state.|Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)|The safety analysis set included all participants who had received at least one dose of study drug.Here “Overall number of participants analyzed” signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2556875|NCT02718417|Secondary|Progression-Free Survival (PFS) as Assessed by Gynecological Cancer Intergroup (GCIG) Criteria|PFS by GCIG was assessed by both RECIST 1.1 and cancer antigen 125 (CA-125). It was defined as time from randomization to first documentation of disease progression (PD) or death, whichever occurred first. As per RECIST 1.1, PD: greater than or equal to (>=) 20 % increase in the sum of diameters of target lesions, taking as reference the smallest sum on study with absolute increase >= 5 millimeters. PD based on serum CA-125 was defined as (i) participants with elevated CA-125 pretreatment and normalization of CA-125, (ii) participants with CA-125 in the reference range before treatment; (i) and (ii) must have showed CA-125 >= 2 times the upper limit of the reference range on 2 occasions >= 1 week apart, or (iii) participants with elevated CA-125 before treatment, which never normalized, showed CA-125 >= 2 times the nadir value on 2 occasions >= 1 week apart. Censoring date for PFS by GCIG was the latest of the censoring dates for PFS by RECIST 1.1 and PFS by CA-125.|Baseline until disease progression by GCIG criteria or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)|The trial was terminated due to crossing of futility boundaries for both experimental arms as compared to the control arm at the pre-specified interim analysis for PFS based on BICR assessment. Subsequently, the data for this outcome measure was not collected and analyzed.||||||
2556876|NCT02718417|Secondary|Progression-Free Survival 2 (PFS2)|PFS2 was defined as time (in months) from the date of randomization to the start of second subsequent treatment after first documentation of PD, or death from any cause, whichever occurred first. Progression as per RECIST version 1.1, was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.|Baseline up to start of second subsequent treatment after first PD or discontinuation from study or death, which ever occured first (maximum duration of 27 months)|The trial was terminated due to crossing of futility boundaries for both experimental arms as compared to the control arm at the pre-specified interim analysis for PFS based on BICR assessment. Subsequently, the data for this outcome measure was not collected and analyzed.||||||
2557119|NCT02714283|Secondary|Sudden Cardiac Arrest|Myocardial infarction event|up to 8 years||||Events|Patient-years||Number
2556877|NCT02718417|Secondary|Percentage of Participants With Pathological Complete Response (pCR)|pCR was defined (for neoadjuvant participants who underwent interval debulking surgery [IDS]), as the chemotherapy response score 3 (CSR3), based on a study by Bohm et al, 2015. CSR3 was defined as complete or near-complete response with no residual tumor or minimal irregularly scattered tumor foci seen as individual cells, cell groups, or nodules up to 2 mm. Complete or near-complete response was defined as complete or near-complete microscopic disappearance of invasive tumor/ residual disease.|Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)|Analysis was performed on a subset of randomized participants which included neoadjuvant participants who underwent IDS.|||percentage of participants|||Number
2556878|NCT02718417|Secondary|Maintenance Progression-Free Survival (PFS) as Assessed by Investigator|Investigator assessed maintenance PFS was defined as the time from Cycle 1 Day 1 of the maintenance phase to the date of the first documentation of PD or death due to any cause, whichever occurs first. It was defined, for participants who proceeded to maintenance phase and who did not have disease progression by investigator during the chemotherapy phase. As per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method|From Day 1 of Cycle 1 (42 days) of maintenance phase to progression of disease or death, whichever occurred first (maximum duration of 27 months)|The analysis set included randomized participants who proceeded to maintenance phase and who did not have PD by investigator assessment during the chemotherapy phase.|||months||95% Confidence Interval|Median
2556879|NCT02718417|Secondary|Maintenance Progression-Free Survival as Assessed by Blinded Independent Central Review (BICR)|BICR assessed maintenance PFS was defined as the time from Cycle 1 Day 1 of the maintenance phase to the date of the first documentation of PD or death due to any cause, whichever occurs first. It was defined, for participants who proceeded to maintenance phase and who did not have disease progression by BICR during the chemotherapy phase. As per RECIST version 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.|From Day 1 of Cycle 1 (42 days) of maintenance phase to progression of disease or death, whichever occurred first (maximum duration of 27 months)|The analysis set included randomized participants who proceeded to maintenance phase and who did not have PD by BICR assessment during the chemotherapy phase.|||months||95% Confidence Interval|Median
2556880|NCT02718417|Secondary|Duration of Response (DOR) as Assessed by Blinded Independent Central Review (BICR)|BICR assessed DOR: time (in months) from the first documentation of objective response (confirmed CR or PR) to the date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.|First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)|Analysis was performed on subset of randomized participants, who had objective response, as assessed by BICR.|||months||95% Confidence Interval|Median
2556881|NCT02718417|Secondary|Duration of Response (DOR) as Assessed by Investigator|Investigator assessed DOR: time (in months) from the first documentation of objective response (confirmed CR or PR) to the date of first documentation of PD or death due to any cause. As per RECIST version 1.1, CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. PR: at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.|First response subsequently confirmed to progression of disease or start of new anti-cancer therapy or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)|Analysis was performed on subset of randomized participants, who had objective response, as assessed by Investigator.|||months||95% Confidence Interval|Median
2556882|NCT02718417|Secondary|Percentage of Participants With Objective Response as Assessed by Blinded Independent Central Review (BICR)|BICR assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of CR or PR. CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.|Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months)|The full analysis set included all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2556906|NCT02718248|Secondary|Physical Functioning|Physical Functioning was measured using the Physical Functioning subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Physical Functioning Subscale is scored using a range of 0-100, with a higher score indicating better physical functioning.|Baseline and Week 5||||units on a scale||Standard Deviation|Mean
2556883|NCT02718417|Secondary|Percentage of Participants With Objective Response as Assessed by Investigator|Investigator assessed objective response according to RECIST version 1.1, was defined as participants with confirmed best overall response of complete response (CR) or partial response (PR). CR was defined as disappearance of all target and non-target lesions, and sustained for at least 4 weeks. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm. PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions.|Baseline to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (maximum duration of 27 months)|The full analysis set included all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2556884|NCT02718417|Secondary|Progression-Free Survival (PFS) as Assessed by Investigator|Investigator assessed PFS was defined as time (in months) from date of randomization to the first documentation of disease progression or death (due to any cause), whichever occurred first. Progression as per RECIST 1.1, was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.|Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)|The full analysis set included all randomized participants.|||months||95% Confidence Interval|Median
2556885|NCT02718417|Secondary|Overall Survival|Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.|Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)|The full analysis set included all randomized participants.|||months||95% Confidence Interval|Median
2556886|NCT02718417|Primary|Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)|BICR assessed PFS: Duration from randomization until disease progression or death. PFS data was censored on the date of the last adequate tumor assessment for participants who did not have an event (progression of disease or death), who started a new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.|Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)|The full analysis set included all randomized participants.|||months||95% Confidence Interval|Median
2556887|NCT02718326|Secondary|Area Under the Curve (AUC) for Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 52|The area under the curve (AUC) is the area under the best corrected visual acuity (BCVA) versus time curve from baseline to week 52. Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).|At week 52|AUC was calculated as a weighted average based on total AUC (using the trapezoidal rule) divided by total duration in days. FAS included all randomized participants who received any study treatment as assigned at baseline (as randomized).|||scores on a scale||Standard Deviation|Mean
2556888|NCT02718326|Secondary|Percentage of Participants Who Received Panretinal Photocoagulation (PRP), Inclusive of Participants Undergoing Vitrectomy With Endolaser, at Week 52|The percentage of participants who received panretinal photocoagulation (PRP), inclusive of participants undergoing vitrectomy with endolaser, at week 52 were reported.|At Week 52|FAS included all randomized participants who received any study treatment as assigned at baseline (as randomized).|||Percentage of participants|||Number
2556889|NCT02718326|Secondary|Time to Development of Central Involved-Diabetic Macular Edema (CI-DME) Through Week 52|Time to develop Central Involved-Diabetic Macular Edema (CI-DME) through week 52 reported.|Baseline through week 52 (day 365)|"FAS included all randomized participants who received any study treatment as assigned at baseline (as randomized). Participants who did not have an event were censored at their last visit, at or before the week 52 visit. Here, the value NA = Not evaluable due to small number of CI-DME events."|||Days||Inter-Quartile Range|Median
2556890|NCT02718326|Secondary|Time to Development of Any Neovascular Vision Threatening Complication (PDR/ASNV) Through Week 52|Vision-threatening complication (VTC) is defined as the composite outcome of proliferative diabetic retinopathy (PDR) (inclusive of participants who have vitreous hemorrhage or tractional retinal detachment believed to be due to PDR) and anterior segment neovascularization (ASNV) (participants with neovascularization of the iris [at least 2 cumulative clock hours], and/or definitive neovascularization of the iridocorneal angle). Vision Threatening Complications include PDR/ASNV identified by investigators and Diabetic Retinopathy Scale Score (DRSS) >61.|Baseline through week 52 (day 365)|"FAS included all randomized participants who received any study treatment as assigned at baseline (as randomized). Participants who did not have an event were censored at their last visit at or before the week 52 visit.~Here, the value NA = Not evaluable due to small number of VTC events."|||Days||Inter-Quartile Range|Median
2556891|NCT02718326|Secondary|Percentage of Participants Who Developed Central Involved-Diabetic Macular Edema (CI-DME) at Week 52|The percentage of participants who developed CI-DME at week 52 were reported.|At Week 52|FAS included all randomized participants who received any study treatment as assigned at baseline (as randomized).|||Percentage of participants|||Number
2556923|NCT02718118|Secondary|Proportion of Responders, at Maximum Frown (Treating Investigator)|Proportion of responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments by treating investigator using a validated 4-point photographic scale.|120 days||||Participants|||Count of Participants
2561913|NCT02643082|Primary|Specific Airway Volume (siVaw)|Specific image-based airway volume. Average across lobe, adjusted for lobe volume|Day 15|ITT Population|||mL/L||95% Confidence Interval|Geometric Least Squares Mean
2556892|NCT02718326|Secondary|Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 52|Vision-threatening complications are defined as the composite outcome of proliferative diabetic retinopathy (PDR) (inclusive of participants who have vitreous hemorrhage or tractional retinal detachment believed to be due to PDR) and anterior segment neovascularization (ASNV) (participants with neovascularization of the iris [at least 2 cumulative clock hours], and/or definitive neovascularization of the iridocorneal angle).|At Week 52|FAS included all randomized participants who received any study treatment as assigned at baseline (as randomized).|||Percentage of participants|||Number
2556893|NCT02718326|Primary|Percentage of Participants With a ≥ 2-step Change at Week 52 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline|The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 52 from baseline.|At Week 52|FAS included all randomized participants who received any study treatment as assigned at baseline (as randomized). The missing data were imputed using LOCF method.|||Percentage of participants|||Number
2556894|NCT02718326|Primary|Percentage of Participants Who Improved by ≥2 Steps From Baseline in the Diabetic Retinopathy Disease Severity Scale (DRSS) Score at Week 24 in the Combined 2Q16 and 2Q8 Groups|The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 24 from baseline.|At Week 24|FAS included all randomized participants who received any study treatment as assigned at baseline (as randomized). The missing data were imputed using last observation carried forward (LOCF) method.|||Percentage of participants|||Number
2556895|NCT02718248|Other Pre-specified|Recruitment Rates at 6 Months|Will be used to assess the feasibility of recruitment for a larger, multicentre cluster randomized controlled trial (RCT). To test feasibility in patients the investigators aim to recruit at least half of the men the study team ask to take part in the pilot study. To test feasibility in referring clinicians, the aim is that at least half of men who present with intentional self-harm to the psychiatric emergency service will be approached and complete the The Ottawa Hospital (TOH) form allowing contact details to be passed on to researchers.|Within 6 months of study launch|This group includes all participants referred to the study (N=15).|||percentage of participants enrolled|||Number
2556896|NCT02718248|Secondary|Participant Exit Questionnaire|The investigators will ask participants about the user comprehension, user practicality and the methods of data collection with regards to the CHESS Mobile Health smart phone application. The Participant Exit Questionnaire will also ask that users make comments or suggestions for future use and development of the application. This will test the acceptability of the intervention and the acceptability of using routine data sources as outcome measures.|within 4 months of study completion||||percentage of participants who agreed|||Number
2556897|NCT02718248|Secondary|Perceived Overall Health|Participants were asked to use the EuroQol 5 Dimensions Visual Analytic Scale to assess their overall health on a scale from 0 to 100, with 100 being the best possible health state.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
2556898|NCT02718248|Secondary|Health-Related Quality of Life|Generic health-related quality of life index. The total scores on this measure range from 11111 to 33333, with lower values indicating higher levels of health-related quality of life.|Baseline and Week 5||||units on a scale||Full Range|Median
2556899|NCT02718248|Secondary|Social Functioning|Social Functioning was measured using the Social Functioning subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Social Functioning Subscale is scored using a range of 0-100, with a higher score indicating higher social functioning.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
2556900|NCT02718248|Secondary|Bodily Pain|Bodily Pain was measured using the Bodily Pain subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Bodily Pain Subscale is scored using a range of 0-100, with a higher score indicating lower levels of bodily pain.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
2556901|NCT02718248|Secondary|Mental Health Functioning|Mental Health Functioning was measured using the Mental Health subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Mental Health Functioning Subscale is scored using a range of 0-100, with a higher score indicating better mental health functioning.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
2556902|NCT02718248|Secondary|General Health|General Health was measured using the General Health subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The General Health Subscale is scored using a range of 0-100, with a higher score indicating higher levels of general health.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
2556903|NCT02718248|Secondary|Vitality|Vitality was measured using the Vitality subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Vitality subscale is scored using a range of 0-100, with a higher score indicating a higher degree of vitality.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
2556904|NCT02718248|Secondary|Emotional Role Limitations|Emotional Role Limitations was measured using the Emotional Role Limitations subscale of the Medical Outcomes Survey Short Form 12 (SF-12). The SF-12 is a 12-item self-report survey that assesses general health and well-being using a total of 8 subscales. The Emotional Role Limitations Subscale is scored using a range of 0-100, with a higher score indicating fewer role limitations due to emotional health difficulties.|Baseline, Week 5||||units on a scale||Standard Deviation|Mean
2556924|NCT02718118|Secondary|Proportion of Responders, at Maximum Frown (Blinded Evaluator)|Proportion of responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments by blinded evaluator using a validated 4-point photographic scale.|120 days||||Participants|||Count of Participants
2556907|NCT02718248|Primary|Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6|"Measures change in the severity of depressive symptoms. Total scores on this scale range from 0 to 27, with higher scores indicating more severe depression symptoms. The scores on the Patient Health Questionnaire (PHQ-9) scale should be interpreted as follows:~0-4: Minimal Depression; 5-9: Mild Depression 10-14: Moderate Depression; 15-19: Moderately Severe Depression; 20 and Above: Severe Depression."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5|Throughout the course of the study, the following study time points were missed: Week 1 (2 participants), Week 3 (1 participant) and Week 4 (1 participant).|||units on a scale||Standard Deviation|Mean
2556908|NCT02718157|Secondary|Indeterminate Sample Results|To estimate the rate of indeterminate results for the GenePOC GBS Test due to an Instrument failure (indeterminate sample results).|At the time of the results with Reference Method is confirmed, up to 6 months||||percentage of Indeterminates||95% Confidence Interval|Number
2556909|NCT02718157|Secondary|Unresolved Sample Results|To estimate the rate of unresolved results for the GenePOC GBS System due to Sample Processing control failure (unresolved sample results).|At the time of the results with Reference Method is confirmed, up to 6 months||||percentage of Unresolved||95% Confidence Interval|Number
2556910|NCT02718157|Secondary|Positive and Negative Predictive Values|"To estimate the Positive and Negative Predictive Values (PPV and NPV) of the GenePOC GBS System.~PPV results from the comparison of specimens being reported as positive by both method against the total number of specimen reported as positive on the Investigational test only. PPV is reported as a percentage (i.e. concondant positives / concordant positive + discordant positive ([False Positive]).~NPV results from the comparison of specimens being reported as negative by both method against the total number of specimen reported as negative on the Investigational test only. NPV is reported as a percentage (i.e. concondant negatives / concordant negatives + discordant negatives ([False Negative])."|At the time of the results with Reference Method is confirmed, up to 6 months||||percentage of specimens||95% Confidence Interval|Number
2556911|NCT02718157|Primary|Performance Characteristics|"To establish the performance characteristics of the GenePOC GBS System for its use in determining the presence of GBS in vaginal/rectal swab, after Lim Broth enrichment, specimens from antepartum pregnant women. Sensitivity and specificity will be established in comparison to the Reference Method.~Sensitivity performance results from the comparison of specimens being reported as positive by both method against the total number of specimen reported as positive on the Reference Method only. Sensitivity is reported as a percentage (i.e. concondant positives / concordant positive + discordant positive ([False Negative]).~Specificity performance results from the comparison of specimens being reported as negative by both method against the total number of specimen reported as negative on the Reference Method only. Specificity is reported as a percentage (i.e. concondant negatives / concordant negatives + discordant negatives ([False Positive])."|At the time of the results with Reference Method is confirmed, up to 6 months||||percentage of specimens||95% Confidence Interval|Number
2556912|NCT02718118|Secondary|Subject Appraisal of Lines Between the Eyebrows (FACE-Q) - Mean Change at Day 120 Compared to Baseline|Mean change from baseline on day 120 using the Subject Appraisal Lines Between the Eyebrows (FACE-Q).Total score for entire questionnaire is transformed to a Rasch score, scale of 0-100. Increase in score = less bothered by glabellar lines.|Baseline and Day 120||||score on a scale||Standard Deviation|Mean
2556913|NCT02718118|Secondary|Subject Age Appraisal Using the FACE-Q-Age Appraisal Visual Analog Scale (VAS) - Mean Change at Day 120 Compared to Baseline|"Mean change from baseline on day 120 using the FACE-Q Age Appraisal VAS. 0 years represents current age subjects rated their appearance as older or younger than current age; + years represents older than current age; - years represents younger than current age."|Baseline and Day 120||||years||Standard Deviation|Mean
2556914|NCT02718118|Secondary|Subject Psychological Well-being - Mean Change at Day 120 Compared to Baseline|"Mean change from baseline on day 120 using the Psychological Well-Being (FACE-Q).Total score for entire questionnaire is transformed to a Rasch score, scale of 0-100.~Increase in score = increased well-being."|Baseline and Day 120||||score on a scale||Standard Deviation|Mean
2556915|NCT02718118|Secondary|Investigator Satisfaction With Treatment Outcome - Satisfied With the Study Product Results|Proportion of treating investigators who responded 'agree' or 'strongly agree' to the individual satisfaction questions on Day 30.|30 days||||Participants|||Count of Participants
2556916|NCT02718118|Secondary|Subject Satisfaction With the Treatment of Glabellar Lines - I am Satisfied With How I Look.|Proportion of subjects who responded 'agree' or 'strongly agree' regarding change from baseline in subject satisfaction questionnaire on day 120.|120 days||||Participants|||Count of Participants
2556917|NCT02718118|Secondary|Proportion of Subjects Who Achieved an Onset of Effect on the Appearance of the Subject's Glabellar Lines.|Combination endpoint from both subject and blinded evaluator assessments. Assessments made on days 2, 3, 4, and 7.|7 days||||Participants|||Count of Participants
2556918|NCT02718118|Secondary|Proportion of Combination Responders, at Rest (Blinded Evaluator and Subject)|Proportion of combination responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by blinded evaluator and subject.|120 days||||Participants|||Count of Participants
2556919|NCT02718118|Secondary|Proportion of Responders, at Rest (Treating Investigator)|Proportion of combination responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by treating investigator using a validated 4-point photographic scale.|120 days||||Participants|||Count of Participants
2556920|NCT02718118|Secondary|Proportion of Responders, at Rest (Blinded Evaluator)|Proportion of responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by blinded evaluator using a validated 4-point photographic scale.|120 days||||Participants|||Count of Participants
2556921|NCT02718118|Secondary|Proportion of Responders, at Rest (Subject)|Proportion of responders, at rest, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by subject using a static 4-point categorical (subject) scale.|120 days||||Participants|||Count of Participants
2556922|NCT02718118|Secondary|Proportion of Combination Responders, at Maximum Frown (Blinded Evaluator and Subject)|Proportion of combination responders, at maximum frown, with GLSS at least 1-point reduction from baseline on days 2, 3, 4, 7, 14, 30, 90 and 120 based on assessments made by blinded evaluator and subject.|120 days||||Participants|||Count of Participants
2556927|NCT02718040|Secondary|Mean Change in Dynamic Facial Strain (Stretch) at Day 42 Compared to Baseline - ML Combined (Global Dynamic Assessment)|Dynamic strain (stretch) results were analyzed using a Global Dynamic Assessment (GDA).The GDA averages strain (stretch) for the 4 predefined individual expressions, providing a global measure of dynamic strain (stretch), for a specific area of interest (ie, ML). This value reflects the mean change in dynamic facial stretch at Day 42 compared to Baseline using 3D imaging.|baseline and 42 days||||Percent of Stretch||Standard Deviation|Mean
2556928|NCT02718040|Secondary|Mean Change in Dynamic Facial Strain (Stretch) at Day 42 Compared to Baseline - NLF Combined (Global Dynamic Assessment)|Dynamic strain (stretch) results were analyzed using a Global Dynamic Assessment (GDA).The GDA averages strain (stretch) for the 4 predefined individual expressions, providing a global measure of dynamic strain (stretch), for a specific area of interest (ie, NLF). This value reflects the mean change in dynamic facial stretch at Day 42 compared to Baseline using 3D imaging.|baseline and 42 days||||Percent of Stretch||Standard Deviation|Mean
2556929|NCT02718040|Secondary|Wrinkle Severity (Assess MLs) - Proportion of Subjects With Bilateral Improvement of at Least 1 Grade in Wrinkle Severity|Wrinkle severity assessed by treating investigator at Day 15/Touch and Day 42 using the Wrinkle Assessment Scale (WAS). Assessments of both MLs were graded according the following responses: 0-no wrinkles, 1-just perceptible wrinkle, 2-shallow wrinkle, 3, moderately deep wrinkle, 4-deep wrinkle, well defined edges, 5-very deep wrinkle, redundant fold. WAS improvement from baseline included 1-grade improvement (reduction in WAS) from baseline.|42 days||||Participants|||Count of Participants
2556930|NCT02718040|Secondary|Wrinkle Severity (Assess NLFs) - Proportion of Subjects With Bilateral Improvement of at Least 1 Grade in Wrinkle Severity|Wrinkle severity assessed by treating investigator at Day 15/Touch and Day 42 using the Wrinkle Severity Rating Scale (WSRS). Assessments of both NLFs were graded according the following responses: 1-absent, 2-mild, 3-moderate, 4-severe, and 5-extreme. WSRS improvement from baseline included 1-grade improvement (reduction in WSRS) from baseline.|42 days||||Participants|||Count of Participants
2556931|NCT02718040|Secondary|Number of Subjects Reporting Satisfaction - The Overall Appearance of my Face Looks Natural|Proportion of subjects responding with Strongly Agree or Agree. Subject reported satisfaction using a 5-point Likert scale questionnaire. Responses were 1-strongly disagree, 2-disagree, 3-neutral, 4-agree, and 5-strongly agree.|42 days||||Participants|||Count of Participants
2556932|NCT02718040|Secondary|Number of Subjects Demonstrating Global Improvement (Treating Investigator)|"Aesthetic improvement assessed by treating investigator using the Global Aesthetic Improvement Scale (GAIS). The treating investigator reported GAIS assessment was based on comparing Day 42 to baseline photographs with the following ratings: Very much improved, much improved, somewhat improved, no change, and worse. A clinically significant global improvement was defined as a score of improved, much improved, or very much improved."|42 days||||Participants|||Count of Participants
2556933|NCT02718040|Secondary|Number of Subjects Reporting Global Improvement (Subject)|"Aesthetic improvement assessed by subject using the Global Aesthetic Improvement Scale (GAIS). The subject reported GAIS assessment was based on comparing Day 42 to baseline photographs with the following ratings: Very much improved, much improved, somewhat improved, no change, and worse. A clinically significant global improvement was defined as a score of improved, much improved, or very much improved."|42 days||||Participants|||Count of Participants
2556934|NCT02718040|Secondary|Number of Subjects With Naturalness of Expression, Attractiveness AND Younger Appearance (2D Video)|Proportion of subjects having at least maintained naturalness of expression in the lower face (naturalness is maintained or enhanced) AND attractiveness of the lower face is enhanced AND age of the lower face is younger, based on 2D video assessment at Day 42, by the treating investigator. The is a composite perception assessment; the proportion of subjects must meet all 3 criteria (maintain naturalness, maintain attractiveness, and appear younger in the lower face.|42 days||||Participants|||Count of Participants
2556935|NCT02718040|Secondary|Number of Subjects With Naturalness of Expression (Photographs)|Proportion of subjects having at least maintained naturalness of facial expression based on photograph assessment at Day 42, by treating investigator|42 days||||Participants|||Count of Participants
2556936|NCT02718040|Primary|Number of Subjects With Naturalness of Expression in Motion (2D Video)|Proportion of subjects having at least maintained naturalness of expression in lower face (naturalness is maintained or enhanced) based on 2D video assessment at Day 42, by treating investigator|42 days||||Participants|||Count of Participants
2556937|NCT02717949|Secondary|Number of Subjects Who Have a Change in Lymph Node Size From Baseline After HCV Treatment|Number of subjects who have a change in the size of lymph node size from baseline|from baseline to post-treament week 36|data not reported due to confidentiality||||||
2556938|NCT02717949|Primary|Number Subjects Who Experience Adverse Events on HCV Treatment as Assessed by Division of AIDS (DAIDS) Adverse Event (AE) Grading Table Version 2.0.|number of subjects who experience treatment-related adverse event on HCV treatment as assessed by DAIDS AE Grading Table version 2.|from drug dispensation until post-treatment week 36|data not reported due to confidentiality||||||
2556939|NCT02717754|Secondary|Minimum Plasma Concentration (Cmin) of RO0640802|Collection of the 12-hour post-dose sample took place prior to administration of the second daily dose of drug. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|12-hour post dose on Day 1, 5 and predose on Day 2, 3, 4, 5|PK analysis population. Only participants who received oseltamivir were analyzed.|||ng/mL||Standard Deviation|Mean
2556940|NCT02717754|Secondary|Clearance (CL) of Oseltamivir and RO0640802|CL is a quantitative measure of the rate at which a drug substance is removed from the body. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.|||Liters/hour||Standard Deviation|Mean
2556941|NCT02717754|Secondary|Volume of Distribution (Vd) of Oseltamivir and RO0640802|Vd is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.|||Liter||Standard Deviation|Mean
2556944|NCT02717754|Secondary|Cmax of Oseltamivir and RO0640802|Cmax is the maximum observed plasma concentration. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1|PK analysis population. Only participants who received oseltamivir were analyzed.|||ng/mL||Standard Deviation|Mean
2556945|NCT02717754|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Oseltamivir and RO0640802|AUC is a measure of the plasma concentration of the drug over time. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.|||ng*hour/mL||Standard Deviation|Mean
2556946|NCT02717754|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Oseltamivir and RO0640802|AUC is a measure of the plasma concentration of the drug over time. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1|PK analysis population. Only participants who received oseltamivir were analyzed.|||ng*hour/mL||Standard Deviation|Mean
2556947|NCT02717754|Primary|Maximum Plasma Concentration (Cmax) of Oseltamivir and RO0640802 at Steady State|Cmax is the maximum observed plasma concentration, presented in nanogram per milliliter (ng/mL). RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5|PK analysis population. Only participants who received oseltamivir were analyzed.|||ng/mL||Standard Deviation|Mean
2556948|NCT02717754|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hour (AUC0-12h) of Oseltamivir and RO0640802 at Steady State|AUC is a measure of the plasma concentration of the drug over time. AUC is presented in nanogram times (*) hour per milliliter (ng*hour/mL). RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.|Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5|Pharmacokinetic (PK) analysis population included all participants who were dosed correctly. Only participants who received oseltamivir were analyzed.|||ng*hour/mL||Standard Deviation|Mean
2556949|NCT02717494|Secondary|Number of Infant Participants With ELISA-measured IgG PNC Antibody Levels ≥ 0.35ug/mL at 16 and 24 Weeks of Age|The number of infant participants with ELISA-measured IgG PNC antibody levels ≥ 0.35ug/mL at 16 and 24 weeks of age to 1 or more serotypes.|at weeks 16 and 24 of life|These are the infants who were born on study and received the PCV-10 vaccination in the windows allowed by the protocol (prior to week 8 and prior to week 16). The number of infants with nonmissing data who received the vaccination as required are indicated.|||Participants|||Count of Participants
2556950|NCT02717494|Secondary|Number of Participants With a Two-fold or Higher Increase in ELISA-measured IgG PNC Antibody Concentrations at 28 Days After PCV-10 Vaccination in Step 1 and Step 2|The proportion of participants with a two-fold or higher increase in ELISA-measured IgG PNC antibody concentrations from baseline to 28 days after immunization in Step 1 vs from entry to Step 2 to 28 days after immunization in Step 2 to 1 or more serotypes.|28 days after Immunization in Step 1 and in Step 2|Women who received PCV-10 in Step 1 or in Step 2 and who had ELISA-measured IgG PNC antibody concentrations data.|||Participants|||Count of Participants
2556951|NCT02717494|Secondary|Number of Participants With a Two-fold or Higher Increase in ELISA-measured IgG PNC Antibody Concentrations at 28 Days After PPV-23 Vaccination in Step 1 and Step 2|The number of participants with a two-fold or higher increase in ELISA-measured IgG PNC antibody concentrations from baseline to 28 days after immunization in Step 1 vs from entry to Step 2 to 28 days after immunization in Step 2 to 1 or more serotypes.|28 days after Immunization in Step 1 and in Step 2|Women who received PPV-23 in Step 1 or in Step 2 and who had ELISA-measured IgG PNC antibody concentrations data.|||Participants|||Count of Participants
2556952|NCT02717494|Secondary|Number of Participants With a >=0.35ug/mL ELISA-measured IgG PNC Antibody Concentrations at Labor/Delivery and 24 Weeks Post-partum|The number of participants with a >=0.35ug/mL ELISA-measured IgG PNC antibody concentrations at the time points listed for 1 or more serotypes.|at Labor and Delivery and 24 Weeks Post-Delivery for Mother Participants|Pregnant women who received the vaccination and did not deliver prior to the day 28 study visit and who had ELISA-measured IgG PNC antibody concentrations measured at the timepoints listed.|||Participants|||Count of Participants
2556953|NCT02717494|Secondary|Ratio of Infant/Mother PNC Antibody Levels|The ratios of infant/mother PNC antibody levels to study used serotypes.|At Delivery for Mother Participants and Birth for Infant Participants|These are the mother-infant pairs who meet the criteria of receipt of study product for the moms and have data for delivery/birth time point.|||ratio||95% Confidence Interval|Mean
2556954|NCT02717494|Primary|Number of Infant Participants With ELISA-measured IgG PNC Antibody Levels ≥ 0.35ug/mL at 8 Weeks of Age|The number of infant participants with ELISA-measured IgG PNC antibody levels ≥ 0.35ug/mL at 8 weeks of age to 1 or more serotypes.|8 Weeks of Life|The are the infants who were born on study and who had blood drawn for the week 8 evaluation prior to receiving their PCV-10 vaccination.|||Participants|||Count of Participants
2556955|NCT02717494|Primary|Number of Women With a Two-fold or Higher Increase in ELISA-measured IgG PNC Antibody Concentrations|"The number of participants with a two-fold or higher increase in ELISA-measured IgG PNC antibody concentrations from baseline to 28 days after immunization in Step 1 to 1 or more serotypes.~The proportion of participants with >=0.35ug/mL ELISA-measured IgG PNC antibody concentrations at 28 days after immunization in Step 1 to 1 or more serotypes."|28 days after Immunization in Step 1|Pregnant women who received the vaccination and did not deliver prior to the day 28 study visit and who had ELISA-measured IgG PNC antibody concentrations measured at baseline and at 28 days after immunization.|||Participants|||Count of Participants
2556956|NCT02717494|Primary|Number of Infants With Various Adverse Events Following Maternal Vaccination With PCV10 and PPV23 Administered in Pregnancy|The number of infants who experience grade ≥ 3 adverse events (AEs), congenital defects, HIV infections or pneumonia, meningitis or IPD after maternal vaccination in Step 1, assessed from birth through 24 weeks of life for infant participants.|through 24 weeks of life for infant participants|Infants who were born on the study.|||Participants|||Count of Participants
2557120|NCT02714283|Primary|Hospitalized Respiratory Infection|Among a national cohort of non-CF bronchiectasis patients, we will compare the effectiveness of corticosteroid and macrolide therapy with regards to prevention of hospitalized respiratory infection.|up to 8 years||||Events|Patient-years||Number
2556957|NCT02717494|Primary|Number of Women Who Experienced Grade ≥ 3 Adverse Events (AEs) in Step 2|The number of women who enrolled in Step 2, received vaccine and who experience grade ≥ 3 adverse events (AEs) in the 4 weeks after vaccination in Step 2 is presented.|up to 4 Weeks after Step 2 vaccination for Mother Participants|Women who received Placebo in Step 1 and who were eligible and were randomized to Step 2.|||Participants|||Count of Participants
2556958|NCT02717494|Primary|Number of Women Who Experienced Various Adverse Events (AEs)|The number of women who experienced grade ≥ 3 adverse events (AEs) in the 4 weeks after vaccination in Step 1 and grade 4 AEs or death up to 24 weeks post-partum. AE grading (Grade 1- mild to Grade 4-life-threatening) was done by DAIDS AE Grading table v2.0 (see References).|up to 24 Weeks Post-Delivery for mother participants.|All women randomized to vaccine or placebo, and who received the study treatment.|||Participants|||Count of Participants
2556959|NCT02717273|Secondary|Number of Subjects With Mortality|death within 30 days of liver transplant|within 30 days from surgery|Had liver transplant|||Participants|||Count of Participants
2556960|NCT02717273|Secondary|Number of Subjects With Graft Loss|complete loss of liver function in recipient|within 30 days from surgery|Had liver transplant|||Participants|||Count of Participants
2556961|NCT02717273|Secondary|Length of Hospital Stay|days hospitalized after liver transplant|within 30 days from surgery|Had liver transplant|||days||Inter-Quartile Range|Median
2556962|NCT02717273|Secondary|Number of Subjects With Nosocomial Infection|diagnosis of any new infection other than an SSI within 30 days from surgery|within 30 days from surgery|Had liver transplant|||Participants|||Count of Participants
2556963|NCT02717273|Secondary|Number of Subjects With Elevated White Blood Count (WBC)|above 15,000 within 24hours after the end of the liver transplant|24 hours from surgery|Had liver transplant|||Participants|||Count of Participants
2556964|NCT02717273|Secondary|Number of Subjects With Post-operative Fever|fever above 38.5 degrees Celsius 24 hours after the end of the liver transplant|24 hours from surgery|Had liver transplant|||Participants|||Count of Participants
2556965|NCT02717273|Primary|Number of Subjects With Development of Surgical Site Infections|development of surgical site infection, including superficial and deep incisional and organ space surgical site infections|within 30 days from surgery|Had liver transplant|||Participants|||Count of Participants
2556966|NCT02717195|Secondary|Response at Week 10, Defined as ≥50% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization|PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.|From Randomization to Week 10|Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.|||Participants|||Count of Participants
2556967|NCT02717195|Secondary|Response at Week 10, Defined as ≥40% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization|PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.|From Randomization to Week 10|Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.|||Participants|||Count of Participants
2556968|NCT02717195|Secondary|Response at Week 10, Defined as ≥30% Reduction in PANSS Total Score From Randomization|Positive and Negative Syndrome Scale (PANSS) total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.|From Randomization to Week 10|Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.|||Participants|||Count of Participants
2556969|NCT02717195|Secondary|Response at Week 10, Defined as ≥20% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization|PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.|From Randomization to Week 10|Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.|||Participants|||Count of Participants
2556982|NCT02716818|Secondary|Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Bone Mineral Density) - Measured at All Sites Except Germany.|Changes relative to Standard glucocorticoid therapy in body composition (DEXA - bone mineral density only) - measured at all sites except Germany.|Baseline and 24 weeks|The efficacy evaluable analysis set (EES) comprised all participants who were randomised into the study, who received at least one dose of Chronocort or standard GC therapy, and who had an evaluable Week 24 17-OHP 24-hour hormone profile, and who had no major protocol violations. German subjects were excluded from this analysis subset.|||g/cm^2||Standard Deviation|Mean
2556970|NCT02717195|Secondary|Response at Week 10, Defined as ≥20% Reduction in PANSS Total Score, PANSS (Positive and Negative Syndrome Scale) Total Score ≤70, CGI-S (Clinical Global Impression Scale - Severity of Illness) Score <4|"PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement.~The Clinical Global Impression scale - severity of illness (CGI-S) is administered by the investigator. The patient is rated on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). A reduction in scale indicates improvement."|From Randomization to Week 10|Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.|||Participants|||Count of Participants
2556971|NCT02717195|Secondary|Change From Randomization to Week 10 in Global Clinical Impression - Severity of Illness (CGI-S) Score|CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate worsening.|From Randomization to Week 10|Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.|||units on a scale||Standard Error|Mean
2556972|NCT02717195|Secondary|Change From Randomization to Week 10 in PSP Total Personal and Social Performance (PSP) Total Score|PSP is a clinician-rated scale designed and validated to measure a patient's current level of social functioning. It consists of 4 items: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behaviours. Each items were assessed on a 6-point scale, from 1 (absent) to 6 (very severe). PSP score was calculated as sum of all the items on the scale and ranged from 4 to 100. A higher score represents more severe functional impairment.|From Randomization to Week 10|Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.|||units on a scale||Standard Error|Mean
2556973|NCT02717195|Primary|Change From Randomization to Week 10 in Positive and Negative Syndrome Scale (PANSS) Total Score|PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia.|From Randomization to Week 10|Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation.|||units on a scale||Standard Error|Mean
2556974|NCT02717130|Primary|Assessment of Hospital Re-admission in a 30 Day Time Frame|Psychiatric re-hospitalization were planning to be assessed using hospital admission records. Study stopped due to lack of enrollment.|30 days|Data was not collected. The number of participants analyzed is 0 because the study was stopped due to lack of enrollment.||||||
2556975|NCT02716896|Secondary|Change From Baseline Level to Year 1 on Genomic Markers After Chemoradiation|Genomic markers will be isolated from the research biological samples, and then measured by tissue RNA microarray.|One year|No subjects that were randomized and completed the study had chemoradiation, so no data were collected for this outcome.||||||
2556976|NCT02716896|Secondary|Total Number of Participants Who Remained Progression-free Within the Time Frame of the Study|Number of participants who completed the study whose disease state did not worsen during participation|One year|Only the participant randomized to radical cystectomy progressed to study completion|||Participants|||Count of Participants
2556977|NCT02716896|Secondary|Total Number of Participants Who Are Able to Keep Their Bladder Within the Time Frame of the Study|Number of participants that were randomized who did not have bladder cystectomy during the one year study period|One year|Only the subject who had radical cystectomy progressed to completion after bladder removal, so zero participants kept their bladder, so no data were collected.||||||
2556978|NCT02716896|Secondary|Change From Baseline and Year 1 in Health Related Quality of Life Measures|Questionnaires such as FACT-Bl (functional assessment of cancer therapyfor patients with bladder cancer), Katz ADL (Katz Index of Independence in Activities of Daily Living), and EORTC (European Organization for Research and Treatment of Cancer), all surveys used to assess quality of life, will be used to measure the changes.|One year|Data collected for this outcome were not analysed due to limited funds and early study termination. Only one subject was randomized to intervention and so insufficient data were collected for analysis.||||||
2556979|NCT02716896|Primary|Total Number of Participants Completed the Study|Number of randomized subjects who completed the study to one year|One year|Subject was withdrawn from radiation and chemoradiation arm of the study by PI due to progression of disease|||Participants|||Count of Participants
2556980|NCT02716896|Primary|Total Number of Participants Withdraw From the Study|Number of randomized participants who were withdrawn from the study by the investigator, or who voluntarily withdrew|One year|Subject in the Radiation and Chemoradiation arm was withdrawn by the PI due to progression of disease|||Participants|||Count of Participants
2556981|NCT02716896|Primary|Total Number of Participants Adhere to the Assigned Treatment|Number of randomized participants that progressed to one year on treatment|One year|There were no study completers in either arm of the study at 1 year. The one subject randomized to surgery but disease state worsened and subject did not complete to one year. Since the participant did not progress to one year on treatment, no analysis was possible. Data were not collected.||||||
2556983|NCT02716818|Secondary|Changes Relative to Standard Glucocorticoid Therapy in Body Composition (DEXA - Fat Mass and Lean Mass)|Changes relative to Standard glucocorticoid therapy in body composition (DEXA) (fat mass and lean mass) - measured at all sites except Germany.|Baseline and 24 weeks|The efficacy evaluable analysis set (EES) comprised all participants who were randomised into the study, who received at least one dose of Chronocort or standard GC therapy, and who had an evaluable Week 24 17-OHP 24-hour hormone profile, and who had no major protocol violations. German subjects were excluded from this analysis subset.|||kilograms||Standard Deviation|Mean
2556984|NCT02716818|Secondary|Number of Participants With 17-OHP and A4 Levels in the Optimal Range at 9:00 at Week 24 Visit|"17-OHP and A4 levels at 09:00 at the week 24 visit, as a responder analysis (i.e. the number of participants achieving results in the optimal range).~Optimal range for 17-OHP (male) = 1.2* - 6.7 nmol/L (female) = 1.2* - 8.6 Optimal range for A4 (male) = 1.4 - 5.2 nmol/L (female) = 1.0 - 7.0 nmol/L~* = There is no lower reference range available for 17-OHP, hence the lower limit of the optimal range was used in the derivation of the average Standard Deviation Score. This enabled calculation of an 'unsigned' SDS score which was used to assess potential over-treatment as well as under-treatment."|24 weeks|The efficacy evaluable analysis set (EES) comprised all participants who were randomised into the study, who received at least one dose of Chronocort or standard GC therapy, and who had an evaluable Week 24 17-OHP 24-hour hormone profile, and who had no major protocol violations. Total sum of participants in the EES = 105.|||Participants|||Count of Participants
2556985|NCT02716818|Secondary|17-OHP and A4 by Individual Baseline Treatment Strata.|17-OHP and A4 by individual baseline treatment strata presented in the same manner as the primary endpoint (using 24-hour SDS profile at 24 weeks). Change from baseline to 24 weeks of the mean of the 24-hour standard deviation score (SDS) - also referred to as a z-score - profile for 17-OHP and A4. This secondary efficacy variable was calculated as follows: the natural logarithm of the mean of the 24-hour SDS for the natural logarithm of 17-OHP and A4. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs with the first and last (13th) weighted one half relative to the intermediate SDSs. For each of the 13 log-transformed 17-OHP and A4 values at each visit, an SDS was calculated by counting the number of SDs that were above or below the mean of the log-transformed range. A negative z-score indicated greater control of 17-OHP and A4 when compared to baseline (0).|24 weeks|The efficacy evaluable analysis set (EES) comprised all participants who were randomised into the study, who received at least one dose of Chronocort or standard GC therapy, and who had an evaluable Week 24 17-OHP 24-hour hormone profile, and who had no major protocol violations. Total sum of participants in the EES = 105.|||Z-score||Standard Deviation|Mean
2556986|NCT02716818|Secondary|Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for A4|Change from baseline to 24 weeks of the mean of the 24-hour standard deviation score (SDS) - also referred to as a z-score - profile for A4 (androstenedione). This secondary efficacy variable was calculated as follows: the natural logarithm of the mean of the 24-hour SDS for the natural logarithm of A4. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs with the first and last (13th) weighted one half relative to the intermediate SDSs. For each of the 13 log-transformed A4 values at each visit, an SDS was calculated by counting the number of SDs that were above or below the mean of the log-transformed range. A negative z-score indicated greater control of A4 when compared to baseline (0).|24 weeks|The efficacy evaluable analysis set (EES) comprised all participants who were randomised into the study, who received at least one dose of Chronocort or standard GC therapy, and who had an evaluable Week 24 17-OHP 24-hour hormone profile, and who had no major protocol violations. Total sum of participants in the EES = 105.|||Z-score||Standard Deviation|Mean
2556987|NCT02716818|Primary|Change From Baseline to 24 Weeks of the Mean of the 24-hour Standard Deviation Score (SDS) Profile for 17-OHP|Change from baseline to 24 weeks of the mean of the 24-hour standard deviation score (SDS) - also referred to as a z-score - profile for 17-OHP (17-Hydroxyprogesterone). The primary efficacy variable was the natural logarithm of the mean of the 24-hour SDS for the natural logarithm of 17-OHP. The mean of the 24-hour SDS profile for each visit was the arithmetic mean of all the SDSs with the first and last (13th) weighted one half relative to the intermediate SDSs. For each of the 13 log-transformed 17-OHP values at each visit, an SDS was calculated by counting the number of SDs that were above or below the mean of the log-transformed range. A negative z-score indicated greater control of 17-OHP when compared to baseline (0).|24 weeks|The efficacy evaluable analysis set (EES) comprised all participants who were randomised into the study, who received at least one dose of Chronocort or standard GC therapy, and who had an evaluable Week 24 17-OHP 24-hour hormone profile, and who had no major protocol violations. Total sum of participants in the EES = 105.|||Z-score||Standard Deviation|Mean
2556988|NCT02716805|Secondary|Number of Subjects With Best Response According to International Myeloma Working Group (IMWG) Consensus Criteria|Response was evaluated by appropriate imaging and myeloma serum/urine tests at the start of Cycle 1 and end of study, with response categorized per IMWG consensus criteria, as follows: stringent complete response (sCR) - CR criteria + normal free light chain (FLC) ratio + no clonal cells in bone marrow; CR - negative immunofixation on serum/urine + no soft tissue plasmacytomas + <5% plasma cells in bone marrow; very good partial response (VGPR) - serum/urine M-protein detectable by immunofixation but not electrophoresis OR ≥90% reduction in serum M-protein + urine <100 mg/24h; PR - ≥50% and ≥90% (or <200 mg/24h) reduction of serum + urine M-protein, respectively; progressive disease - increase of ≥25% serum and/or urine M-component, increase of >10 mg/dL in involved and uninvolved FLC levels, bone marrow plasma cells ≥10%, new or larger lesions, or corrected serum calcium >11.5 mg/dL or 2.65 mmol/L [Rajkumar et al. Blood 2011;117:4691-5; Durie et al. Leukemia 2006;20:1467-73].|Up to 14 months|All subjects who received at least 1 dose of study treatment and underwent at least 1 post-baseline disease assessment.|||Participants|||Count of Participants
2557010|NCT02716714|Secondary|Sustained CC Rate in CC Group|Sustained Complete Clearance means that Complete Clearance was maintained until Month 6 in complete clearance (CC) group and sustained complete clearance(CC) rate at month 6 for complete clearance(CC) group was analyzed.|at 6 months|In intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study), CC Group consisted of 54 participants who had at least 1 follow-up after achieving complete clearance of AK lesions on Day 57.|||Participants|||Count of Participants
2561915|NCT02643004|Secondary|Lens Surface - Wettability|Lens wettability for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline||||percentage of subjects|||Number
2556989|NCT02716805|Primary|Number of Subjects With Treatment-emergent Adverse Events|Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from the time of enrollment through the end of the study period. DLTs were assessed from the first dose of study drug through the Cycle 2 administration of tremelimumab ± durvalumab post ASCT. DLTs were defined per protocol as lack of neutrophil/platelet engraftment by Day 30 post ASCT; Grade 5 toxicity (treatment-related death); Grade 4 non-hematological toxicity; Grade 3 non-hematological toxicity (with exclusions); isolated Grade 3 electrolyte abnormalities; or immune-related AEs resulting in discontinuation of treatment.|up to 14 months|All treated subjects.|||Participants|||Count of Participants
2556990|NCT02716779|Secondary|Time to Maximum Concentration (Tmax) of GPT|Tmax was obtained directly from the concentration-time data.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.|||days||95% Confidence Interval|Median
2556991|NCT02716779|Secondary|Maximum Concentration (Cmax) of GPT|Cmax was obtained directly from the concentration-time data.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.|||U/L||95% Confidence Interval|Median
2556992|NCT02716779|Secondary|Area Under the Concentration-Time Curve (AUC) of Glutamate-Pyruvate Transaminase (GPT)||From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.|||(Units/liter)*day ([U/L]*d)||95% Confidence Interval|Median
2556993|NCT02716779|Secondary|Time to Maximum Concentration (Tmax) of PEG-IFN|Tmax was obtained directly from the concentration-time data. Evaluation of PEG-IFN arm after day 0. Evaluation of ribavirin and placebo arms after day 42.|From Day 0 at 0 hour (hr), 24 hr, 48 hr and 72 hr, Day 42 at 0 hr and 24 hr and at approximately every other visit up to Day 126|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.|||weeks||95% Confidence Interval|Median
2556994|NCT02716779|Secondary|Maximum Concentration (Cmax) of PEG-IFN|Cmax was obtained directly from the concentration-time data. Evaluation of PEG-IFN arm after day 0. Evaluation of ribavirin and placebo arms after day 42.|From Day 0 at 0 hour (hr), 24 hr, 48 hr and 72 hr, Day 42 at 0 hr and 24 hr and at approximately every other visit up to Day 126|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.|||ng/ml||95% Confidence Interval|Median
2556995|NCT02716779|Secondary|Area Under the Concentration-Time Curve (AUC) of PEG-IFN|Evaluation of PEG-IFN arm after Day 0. Evaluation of ribavirin and placebo arms after Day 42.|From Day 0 at 0 hour (hr), 24 hr, 48 hr and 72 hr, Day 42 at 0 hr and 24 hr and at approximately every other visit up to Day 126|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.|||(nanogram/milliliter)*day ([ng/ml]*d)||95% Confidence Interval|Median
2556996|NCT02716779|Secondary|Time to Maximum Concentration (Tmax) of Ribavirin|Tmax was obtained directly from the concentration-time data. Evaluation of ribavirin arm after day 0. Evaluation of placebo and PEG-IFN arms after day 42.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.|||weeks||95% Confidence Interval|Median
2556997|NCT02716779|Secondary|Maximum Concentration (Cmax) of Ribavirin|Cmax was obtained directly from the concentration-time data. Evaluation of ribavirin arm after day 0. Evaluation of placebo and PEG-IFN arms after day 42.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.|||mcg/ml||95% Confidence Interval|Median
2556998|NCT02716779|Secondary|Area Under the Concentration-Time Curve (AUC) of Ribavirin|Evaluation of ribavirin arm after Day 0. Evaluation of placebo and PEG-IFN arms after Day 42.|From Day 0 at 0 hour (hr), 12 hr, 24 hr, 36 hr, 48 hr, 60 hr and 72 hr, Day 42 at 0 hr, 12 hr, 24 hr and 36 hr and at each visit up to Day 126.|All evaluable participants of the ITT population, who were documented for a total of 126 days of the treatment period.|||(microgram/milliliter)*day ([mcg/ml]*d)||95% Confidence Interval|Median
2556999|NCT02716779|Secondary|Percentage of Participants With Treatment Response|HCV-RNA level was measured at each visit by a central laboratory. Treatment response was estimated applying the following definitions of response/non-response: 1) Adequate first phase decline: HCV RNA decline ≥ 0.5 log10 International Units/milliliter (IU/mL) from time 0 to 48 hours of PEG-IFN treatment (PEG-IFN arm: day 0 - day 2; placebo and ribavirin arm: day 42-day 44), 2) Rapid virologic response: HCV RNA < 15 IU/mL (=detection limit) on day 70, 3) Complete early virologic response: HCV RNA < 15 IU/mL on day 126, 4) Partial early virologic response (log decrease): HCV RNA decrease ≥ 2 log10 IU/mL from day 0 to day 126, 5) Partial early virologic response (cut off): HCV RNA <30000 IU/mL on day 126, 6) Non-response: HCV RNA decrease <2 log10 IU/mL from day 0 to day 126, 7) Null-response: HCV RNA decrease <1 log10 IU/mL from day 0 to day 28 and from day 0 to day 70 for PEG-IFN arm and placebo / ribavirin arm, respectively.|Up to Day 126|All evaluable participants of the Intent-to-Treat (ITT) population, who were documented for a total of 126 days of the treatment period.|||percentage of participants|||Number
2557011|NCT02716714|Secondary|Percentage Change of the Number of AK Lesions in the Selected Treatment Area|Percentage change from baseline in the number of actinic keratiosis(AK) lesions in the selected treatment area on Day 57 was analyzed.|Baseline and Day 57|Intent to treat population(Intention To Treat (ITT) set was defined as all subjects who applied the investigational product at least once after the enrollment and allocation during this study).|||percentage change||Standard Deviation|Mean
2557024|NCT02716506|Primary|Quality of Life After the POP Surgery|Quality of life is measured by using 15 dimensional quality of health measurement instrument. Minimum value is 0 and maximum value is 1. Higher scores mean better outcome.|24 months after the surgery|Analysis of the patients who answered the 15-D questionnaire 24 months after the operation.|||units on a scale||95% Confidence Interval|Mean
2557000|NCT02716779|Secondary|Score in Quality of Life Assessed Using Short Form-36 (SF-36) Health Questionnaire|"SF-36 is a psychometric scale to quantify health conditions. This psychometric scale has 8 dimensions of the subjective health status and consists of 36 individual items that have a varying number of related item scores (ranging from yes/no up to a 6-point scale). At first the raw scores were determined by summation over all items and weighted accordingly. Afterwards the raw scores were transformed to ranges of 0-100 with 100 being the highest level of health and compared to published reference scales. The following eight dimensions of subjective health conditions were considered: physical functioning index, role physical index, pain, general health perception, vitality, social functioning index, role emotional index and mental health index. The SF36 questionnaire had to be answered by the patients at screening before monotherapy, after monotherapy and at the end of the study (=end of combination therapy)."|At screening (Days -56 to -1), at end of monotherapy (Week 6) and at end of combination therapy (Week 18)|Intent-to-treat (ITT) population includes all randomized participants who received at least one dose of study drug. Here, 'n' is the number of evaluable participants.|||units on a scale||Standard Deviation|Mean
2557001|NCT02716779|Primary|Log Likelihood Median Values of Hepatitis C-Virus (HCV) Kinetic Models for Quantitative HCV Ribonucleic Acid (RNA) Measurement With Various Assumptions of Ribavirin Mechanism of Action|To investigate possible action mechanisms, three different models were fitted to viruskinetic data and evaluated using related log-likelihood function values. These models were designed assuming individual effects with respect to infectiousness (model 1), virus production (model 2) or degradation of infected cells rate (model 3). The following viruskinetic parameters were fitted in each model: initial viral load, loss rate of infected cells (delta), effectivity of interferon with respect to a pharmacokinetic-pharmacodynamic model. A lower log likelihood function value indicates a lesser fit for the model.|Up to Day 126|Per Protocol (PP) population: participants with 6 weeks of monotherapy and at least 4 weeks combination therapy as well as three quantitative HCV-RNA measurements (baseline, period 1, period 2), no major protocol violations, no treatment interruption and no dose reduction below 80% of the planned medication within the first 10 therapy weeks.|||log likelihood function value||95% Confidence Interval|Median
2557002|NCT02716714|Other Pre-specified|Non-Drug Treatment/Surgery for Actinic Keratosis|The count of participants in complete clearance(CC) group and Non-CC group who received non-drug treatment/surgery for actinic keratosis on the selected treatment area after Day 57 was collected.|from 57 days to 6 months|The number of participants who had at least 1 follow-up after assessment of treatment response on Day 57 and which is consisit of CC group(54 participants) and Non-CC group(13 participants). The CC group /Non-CC group for Ingenol Mebutate Gel 0.015% and 0.05% were intended to be analyzed together.|||Participants|||Count of Participants
2557003|NCT02716714|Other Pre-specified|Medication for Actinic Keratosis|The count of participants in complete clearance(CC) group and Non-CC group who administered medication for actinic keratosis on the selected treatment area after Day 57 was collected.|from 57 days to 6 months|The number of participants who had at least 1 follow-up after assessment of treatment response on Day 57 was 67 and which is consisit of CC group(54 participants) and Non-CC group(13 participants). The CC group and Non-CC group for Ingenol Mebutate Gel 0.015% and 0.05% were intended to be analyzed together.|||Participants|||Count of Participants
2557004|NCT02716714|Secondary|Time to Relapse in CC Group|Time to relapse in complete clearance(CC) Group was analyzed. Median survival time with 95% confidence interval was calculated by Kaplan-Meier method.|at 6 months|CC Group consisted of 54 participants who had at least 1 follow-up after achieving Complete Clearance of AK lesions on Day 57.|||days||95% Confidence Interval|Median
2557005|NCT02716714|Secondary|Cosmetic Outcomes Assessment (COA)|The investigator rated the subject's Cosmetic Outcomes Assessment(COA) using 5 grades (Very good, Good, No change, Bad, Very bad), and results were as follows.|at 29 and 57 days from baseline|Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).|||Participants|||Count of Participants
2557006|NCT02716714|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM)|"Participants personally completed the tool to evaluate satisfaction with drug treatment. It consisted of 4 areas of Effectiveness, side effect, convenience, and global satisfaction, with a total of 14 sub-items. The full mark is 100, and it is divided in four stages as follows.~Very good: 76 -100 score~Good: 51-75 score~Not bad: 26-50 score~Bad: 0-25 score Scores for each area ranged from 0 to 100, with higher scores indicating that fewer side effects had occurred and greater treatment satisfaction."|at 29 and 57 days from baseline|Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).|||units on a scale||Standard Deviation|Mean
2557007|NCT02716714|Secondary|Change From Baseline in Quality of Life (Skindex-29)|Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores for each of the domains represents a better Quality of life.|at 29 and 57 days from baseline|Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).|||units on a scale||Standard Deviation|Mean
2557008|NCT02716714|Secondary|Percentage Change of the Number of AK Lesions in the Selected Treatment Area of CC Group|Percentage change from baseline in the number of actinic keratiosis(AK) lesions at Month 6 in the selected treatment area in complete clearance(CC) Group was analyzed.|at 6 months from baseline|In intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study), CC Group consisted of 54 participants who had at least 1 follow-up after achieving complete clearance of AK lesions on day 57.|||Percentage change||Standard Deviation|Mean
2557009|NCT02716714|Secondary|Recurrence Rate in CC Group|Recurrence rate in complete clearance(CC) group was analyzed.|at 6 months|In intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study), CC Group consisted of 54 participants who had at least 1 follow-up after achieving complete clearance of AK lesions on Day 57.|||Participants|||Count of Participants
2557121|NCT02714283|Primary|Nontuberculous Mycobacterial (NTM) Disease|Incidence of treated pulmonary nontuberculous mycobacterium (NTM) disease|up to 8 years|Analysis population excluded all patients with a history of NTM treatment or diagnosis prior to exposure start.|||Events|Patient-years||Number
2557012|NCT02716714|Primary|CC Rate of AK Lesions in the Selected Treatment Area|Complete Clearance (CC) means that clearance of all visible AK lesions in the selected treatment area and Investigator-rated actinic keratiosis(AK) lesion complete clearance (CC) rate at the selected treatment area on day 57 was analyzed.|at day 57|Intent to treat population(all participants who applied the investigational product at least once after the enrollment and allocation during this study).|||Participants|||Count of Participants
2557013|NCT02716584|Secondary|Negative Symptom Subscale Score From the BPRS|The Brief Psychiatric Rating Scale (BPRS) is a measure of psychiatric symptom severity and includes subscale scores for positive and negative symptoms. The outcome score for negative symptoms is calculated by summing the ratings for items measuring blunted affect, emotional withdrawal, and motor retardation; each item is rated on a scale of 1 to 7 with higher scores indicating greater symptom severity; possible range for negative symptoms is 0 to 21 with higher scores representing greater severity of negative symptoms.|Change from baseline to the 12-week endpoint assessment||||score on a scale||Standard Deviation|Mean
2557014|NCT02716584|Secondary|Positive Symptom Subscale Score From the BPRS|The Brief Psychiatric Rating Scale (BPRS) is a measure of psychiatric symptom severity and includes subscale scores for positive and negative symptoms. The outcome score for positive symptoms is calculated by summing the ratings for items measuring hallucinations, unusual thought content, and conceptual disorganization; each item is rated on a scale of 1 to 7 with higher scores indicating greater symptom severity; possible range for positive symptoms is 0 to 21 with higher scores representing greater severity of positive symptoms.|Change from baseline to the 12-week endpoint assessment||||score on a scale||Standard Deviation|Mean
2557015|NCT02716584|Secondary|BDNF Value|BDNF concentration will be quantified by enzyme-linked immunosorbent assay (R&D Systems). The value will be expressed in ng/ml.|Change from baseline to the 12-week endpoint assessment||||ng/ml||Standard Deviation|Mean
2557016|NCT02716584|Secondary|Composite Score From Social Cognition Battery|Raw scores (i.e., total scores) for the following tests will be transformed to z-scores: emotion perception (Facial Emotion Identification Test), social perception (Half-Profile of Nonverbal Sensitivity; PONS), theory of mind (The Awareness of Social Inference Test; TASIT - Part 2), empathy (empathic accuracy test). The outcome measure is the mean z-score. The composite z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean of the overall sample of study participants. Negative numbers indicate values lower than other study participants and positive numbers indicate values higher than other study participants.|Change from baseline to the 12-week endpoint assessment||||z-score||Standard Deviation|Mean
2557017|NCT02716584|Primary|Composite Score From Non-social Cognition Battery|Raw scores (i.e., total scores) for the following tests will be transformed to z-scores: attention (CPT-IP), speed of processing (BACS symbol coding), working memory (WAIS-IV letter-number sequencing test), verbal learning (Hopkins Verbal Learning Test - Revised), and executive control (AX-CPT). The outcome measure is the mean z-score. The composite z-score indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the mean of the overall sample of study participants. Negative numbers indicate values lower than other study participants and positive numbers indicate values higher than other study participants.|Change from baseline to the 12-week endpoint assessment||||z-score||Standard Deviation|Mean
2557018|NCT02716584|Primary|Total Score for Negative Affect as Assessed by the Positive and Negative Affect Scale (PANAS)|Positive and Negative Affect Scale is a measure of an individual's positive and negative affect. The scale includes 32 items; 16 denote positive affect and 16 denote negative affect. Each item is rated on a scale of 1 (very slightly or not at all) to 5 (extremely). The total score for PANAS negative affect is calculated by summing the ratings for items denoting negative affect. Scores range from 16 to 80; lower scores represent better levels of negative affect.|Change from baseline to the 12-week endpoint assessment||||score on a scale||Standard Deviation|Mean
2557019|NCT02716584|Primary|Total Score for Positive Affect as Assessed by the Positive and Negative Affect Scale (PANAS)|Positive and Negative Affect Scale is a measure of an individual's positive and negative affect. The scale includes 32 items; 16 denote positive affect and 16 denote negative affect. Each item is rated on a scale of 1 (very slightly or not at all) to 5 (extremely). The total score for PANAS positive affect is calculated by summing the ratings for items denoting positive affect. Scores range from 16 to 80; higher scores represent better positive affect.|Change from baseline to the 12-week endpoint assessment||||score on a scale||Standard Deviation|Mean
2557020|NCT02716584|Primary|Total Score for Speed of Processing (i.e., Cognition) as Assessed by the Brief Assessment of Cognition in Schizophrenia (BACS) Symbol Coding Test|Brief Assessment of Cognition in Schizophrenia (BACS) is a measure of speed of information processing. The total score for speed of processing (i.e., cognition) is calculated by summing the number of symbol-code pairs completed correctly on the BACS Symbol Coding test within the allotted 90 second time limit. Scores range from 0 to 110 with higher scores representing better information processing speed.|Change from baseline to 12-week endpoint assessment||||score on a scale||Standard Deviation|Mean
2557021|NCT02716584|Primary|Total Score for Social Functioning|Birchwood Social Functioning Scale is a measure of social functioning. The total score for social functioning is calculated by summing the raw scores from each of the seven subscales (social engagement, interpersonal communication, independence - performance, independence - competence, recreation, prosocial behavior, employment); possible range is 0 to 223 with higher scores representing better social functioning.|Change from baseline to 12 week endpoint assessment||||score on a scale||Standard Deviation|Mean
2557022|NCT02716584|Primary|VO2max|Measure of aerobic capacity (VO2max) is derived by using a regression formula based on age, weight, sex, and time to complete walking of one mile. Because scores are derived using a regression equation, there is no absolute minimum or maximum value; higher scores represent better aerobic capacity.|Change from baseline to 12-week endpoint assessment||||ml.kg-1.min-1||Standard Deviation|Mean
2557023|NCT02716506|Secondary|Symptoms Related to Pelvic Organ Prolapse|Condition-specific questionnaire Pelvic Floor Distress Inventory (PFDI-20) is used. Minimum value is 0 and maximum value is 300. Higher scores mean more bothersome symptoms.|24 months after the surgery|Change in PFDI-20 scores 24 months after the operation compared to the baseline scores.|||score on a scale||Standard Deviation|Mean
2558803|NCT02688842|Secondary|Participants With Target Lesion Failure|a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)|12 months after stent implantation||||Participants|||Count of Participants
2557025|NCT02716324|Secondary|Engagement Measure Scores|The Engagement Measure is a 28-item parent self-report measure comprised of four domains: Access (5-items, total score range 5-25), Patient Family Centered Care or PFCC (6-items, total score range 6-30), Communication (3-items, total score range 3-15), and Understanding (5-items, total score range 5-25). Total scores are not reported below. Scores for each individual item and therefore the mean for each domain (means reported in the table below) ranged from 1-5 with higher scores indicating greater engagement. The time range given for Visit 4 reflects the time range counted as a single value.|Visit 4 (9-12 months)||||Score on a scale||Standard Deviation|Mean
2557026|NCT02716324|Secondary|Family Relationships|Family Relationships is a 6-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the 30-item Child- (age 8-12) Patient Reported Outcomes Measures of relationships with other family members over the past 4 weeks. The minimum total score for the Family Relationships domain is 6 and the maximum total score is 30 (total scores not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Child-reported PRO measures were averaged for each domain for each time point. Higher scores indicate better outcomes. Family Relationships PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.|Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)|Row values may differ from overall number for analysis due to missing data.|||Score on a scale||Standard Deviation|Mean
2557027|NCT02716324|Secondary|Peer Relationships|Peer Relationships is a 6-item domain (minimum=1, maximum=5, on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and a 7-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score is 6 and the maximum total score is 30 on the Child PROs. The minimum total score for the Peer Relationships domain is 7 and the maximum total score is 35 on the Parent PROs. Total scores not shown below. Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Higher scores indicate better outcomes. Peer Relationships PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.|Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)|Row values may differ from overall values due to missing data and due to child measures being completed only by children 8-12 years old.|||Score on a scale||Standard Deviation|Mean
2557028|NCT02716324|Secondary|Teacher Connectedness|Teacher Connectedness is a 9-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the Teacher Connectedness domain is 9 and the maximum total score is 45 (total scores not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Teacher Connectedness PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.|Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)|Row values may differ from overall number analyzed due to missing data.|||Score on a scale||Standard Error|Mean
2557029|NCT02716324|Secondary|Student Engagement|Student Engagement is a 4-item domain (minimum score=1, maximum score=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the Student Engagement domain is 4 and the maximum total score is 20 (total scores are not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Student Engagement PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.|Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)|Row values may differ from overall values due to missing data and due to child measures being completed only by children 8-12 years old.|||Score on a scale||Standard Deviation|Mean
2557030|NCT02716324|Secondary|School Performance|School Performance is a 5-item domain (minimum score=1, maximum score=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the School Performance domain is 5 and the maximum total score is 25 (total scores are not shown below). Values in the table below are reported as mean scores at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. School performance PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.|Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)|Row values may differ from overall values due to missing data and due to child measures being completed only by children 8-12 years old.|||Score on a scale||Standard Deviation|Mean
2557031|NCT02716324|Secondary|Treatment Adherence and Use of Services|Using responses from the Services Assessment for Children and Adolescents (SACA), a well-validated client-reported tool and provides information on any mental health services use, ambulatory services use, and inpatient service use, we determined (yes/no) whether participants ever received educational services, mental health services, or medications for ADHD. Parents reported whether their children used services ever or within the last nine months. Treatment adherence was measured by use of services in the past nine months. Categorizations include any service use, ambulatory service use (any community mental health or outpatient clinic, private professional, or in-home provider), and overnight stay (psychiatric or medical unit, residential treatment center, group home, or foster home). The time range of 9-12 given for Visit 4 reflects the time range counted as a single value.|9-12 months (Visit 4)|Rows may differ from overall umber analyzed due to missing data. Values and percentages for Ambulatory and Overnight services do not add up to the over n listed for the column due to missing data and logic structure of the Service Assessment for Children and Adolescents (SACA).|||Participants|||Count of Participants
2557032|NCT02716324|Secondary|Treatment Initiation and Use of Services|Using responses from the Services Assessment for Children and Adolescents (SACA), a well-validated client-reported tool and provides information on any mental health services use, ambulatory services use, and inpatient service use, we determined (yes/no) whether participants ever received educational services, mental health services, or medications for ADHD. Parents reported whether their children used services ever or within the last nine months. Treatment initiation was measured by use of services ever. Categorizations include any service use, ambulatory service use (any community mental health or outpatient clinic, private professional, or in-home provider), and overnight stay (psychiatric or medical unit, residential treatment center, group home, or foster home). The time range of 9-12 given for Visit 4 reflects the time range counted as a single value.|9-12 months (Visit 4)|Numbers may not add to column totals due to missing data. Values and percentages for Ambulatory and Overnight services do not add up to the over n listed for the column due to missing data and logic structure of the Service Assessment for Children and Adolescents (SACA).|||Participants|||Count of Participants
2557033|NCT02716324|Secondary|Mean Goal Attainment Scale (GAS) Score by Timepoint|"The GAS is a 5-point likert scale that assesses the degree to which parents' goals (obtained from the ADHD Preferences and Goals Instrument) are attained from none to completely. The GAS response categories are ordered from 0 (no change) to 6 (goal completely met). Higher scores indicate greater goal attainment. The GAS was measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value."|Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)||||Units on a scale||Standard Deviation|Mean
2557034|NCT02716324|Primary|Change in Vanderbilt Parent Rating Scales (VPRS)|"The VPRS is a public domain tool that consists of forms completed by the child's parent and includes 18 items corresponding to the DSM-5 ADHD symptom criteria, 8 performance items, and 12 items assessing side effects. The VPRS items are scaled on a 4-point Likert rating (never to very often), and the scales used in this study were restricted to the 18 ADHD symptom items. Total scores were used to measure ADHD Symptoms. Higher scores indicated worse outcome. VPRS were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value. The VPRS measures ADHD symptoms and is scaled on a 4-point Likert rating (never to very often). The scale includes 18 ADHD symptom items with total scores ranges from 0-54."|Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)|Row differs from the overall number due to missing data.|||score on a scale||Standard Deviation|Mean
2557035|NCT02716298|Primary|Surface Deposits|Surface deposits for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)|Baseline, 1 month|One participant excluded from analysis at 1 month.|||units on a scale||Standard Deviation|Mean
2557036|NCT02716298|Primary|Lens Wettability|Lens wettability for fanfilcon A and lotrafilcon B lens. (Scale 0-4, 0.25 steps, 0=excellent, 4=severely reduced)|Baseline, 1 month|One participant excluded from analysis at 1 month.|||units on a scale||Standard Deviation|Mean
2557037|NCT02716298|Primary|Subjective Preference|"Subjective ratings on preference for fanfilcon A and lotrafilcon B lens. (Strongly prefer fanfilcon A, slightly prefer fanfilcon A, no preference, slightly prefer lotrafilcon B, strongly prefer lotrafilcon B).~Subject preference in terms of comfort, dryness, clear vision, Lens Handling, digital devices, all day natural comfort, All day comfort, same comfort at the end of the day (EOD), comfortable after the end of 4 weeks, Same comfort at 4 weeks as initial, comfortable in dry environments, help focus effortlessly while using digital devices, help with end of day (EOD) dryness, help eyes feel less tired at EOD (including computer or digital device use), offering clear vision during driving."|1 month||||percentage of participants|||Number
2557038|NCT02716298|Primary|Subjective Comfort|Subjective ratings on comfort at insertion (at baseline), comfort when lenses are first put in, comfort during the day's wear, and comfort prior to lens removal (1 month) for fanfilcon A and lotrafilcon B lens. (Scale 0-10, 10=Can't feel the lenses, 0=Painful).|Baseline, 1 month||||units on a scale||Standard Deviation|Median
2557039|NCT02716194|Secondary|Summary of Assessment of Dose Proportionality for BAX 826|Dose Proportionality for BAX 826 was calculated for the parameters Area under the concentration-time curve from 0 to infinity (AUC0-∞), Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC0-last) and Maximum plasma concentration (Cmax).|Pre-infusion within 30 minutes; and post-infusion at 15 and 30 minutes, and 1, 3, 6, 9, 12, 24, 32, 48, 56, 72, 96, 120, 144, and 168 hours.|The PK analysis set consists of all subjects that have received at least 1 administration of ADVATE or BAX 826 and are evaluable for PK for one or both treatments.|||Doubling dose increase||95% Confidence Interval|Number
2557040|NCT02716194|Secondary|Comparison of Key Pharmacokinetic Parameters by Cohort|The key pharmacokinetic parameters (Area under the concentration-time curve from 0 to infinity (AUC0-∞), Area under the concentration-time curve from 0 to 72 hours (AUC0-72h), Maximum plasma concentration (Cmax), Terminal half-life (t1/2), Mean residence time (MRT) and Total body clearance (CL)) for ADVATE and BAX 826 have been compared.|Pre-infusion within 30 minutes; and post-infusion at 15 and 30 minutes, and 1, 3, 6, 9, 12, 24, 32, 48, 56, and 72 hours for both BAX 826 and ADVATE. BAX 826 will also include post-infusion at 96, 120, 144, and 168 hours.||||Ratio of Geometric Means (%)||95% Confidence Interval|Number
2557041|NCT02716194|Secondary|Pharmacokinetics: Area Under the Concentration-time Curve From 0 to 168 Hours (AUC0-168h) for BAX 826|AUC from time zero to exactly 168 hours, calculated by linear-up/log-down trapezoidal method. If the sample at 168 hours is missing, the activity at 168 hours was interpolated or extrapolated using the last quantifiable activity and the terminal rate constant (lambda z). This parameter will be calculated for BAX 826 only.|Pre-infusion within 30 minutes; and post-infusion at 15 and 30 minutes, and 1, 3, 6, 9, 12, 24, 32, 48, 56, 72, 96, 120, 144, and 168 hours.||||IU*h/dL||Geometric Coefficient of Variation|Geometric Mean
2557063|NCT02715726|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12: ITT Analysis|Adjusted means and standard errors at Week 12 were obtained from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 12|ITT population.|||percent Change||Standard Error|Mean
2557836|NCT02702193|Secondary|Trajectory of Pain Experienced by Participants|Self-reported experience with pain over the past 7 days as measured by the PROMIS 29 pain subscale. Each item is scored 1-5, yielding a total between 5 and 25.|baseline, 4, 8 and 12 months|Intent to Treat analysis|||Participants|||Count of Participants
2557042|NCT02716194|Secondary|Pharmacokinetics: Area Under the Concentration-time Curve From 0 to 72 Hours (AUC0-72h)|AUC from time zero to exactly 72 hours, calculated by linear-up/log-down trapezoidal method. If the sample at 72 hours is missing, the activity at 72 hours will be interpolated or extrapolated using the last quantifiable activity and the terminal rate constant (lambda z).|Pre-infusion within 30 minutes; and post-infusion at 15 and 30 minutes, and 1, 3, 6, 9, 12, 24, 32, 48, 56, and 72 hours for both BAX 826 and ADVATE. BAX 826 will also include post-infusion at 96, 120, 144, and 168 hours.|In period 1 (ADVATE) the number of participants is 11,16,12 respectively for Cohorts 1, 2 and 3. In period 2 (BAX 826) the number of participants is 8, 10 and 11 respectively for cohorts 1, 2 and 3 (10 participants were excluded from the PK analysis for period 2).|||IU*h/dL||Geometric Coefficient of Variation|Geometric Mean
2557043|NCT02716194|Secondary|Pharmacokinetics: Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Time Point (AUC0-last)|Area under the FVIII activity-time curve from zero to the last quantifiable FVIII activity, calculated by linear-up/log-down trapezoidal method.|Pre-infusion within 30 minutes; and post-infusion at 15 and 30 minutes, and 1, 3, 6, 9, 12, 24, 32, 48, 56, and 72 hours for both BAX 826 and ADVATE. BAX 826 will also include post-infusion at 96, 120, 144, and 168 hours.|In period 1 (ADVATE) the number of participants is 11,16,12 respectively for Cohorts 1, 2 and 3. In period 2 (BAX 826) the number of participants is 8, 10 and 11 respectively for cohorts 1, 2 and 3 (10 participants were excluded from the PK analysis for period 2).|||IU*h/dL||Geometric Coefficient of Variation|Geometric Mean
2557044|NCT02716194|Secondary|Pharmacokinetics: Time to Maximum Concentration in Plasma (Tmax)|Time of maximum FVIII activity is obtained directly from FVIII activity versus time data|Pre-infusion within 30 minutes; and post-infusion at 15 and 30 minutes, and 1, 3, 6, 9, 12, 24, 32, 48, 56, and 72 hours for both BAX 826 and ADVATE. BAX 826 will also include post-infusion at 96, 120, 144, and 168 hours.|In period 1 (ADVATE) the number of participants is 11,15,12 respectively for Cohorts 1, 2 and 3. In period 2 (BAX 826) the number of participants is 8, 10 and 11 respectively for cohorts 1, 2 and 3 (9 participants were excluded from the PK analysis for period 2).|||hours||Full Range|Median
2557045|NCT02716194|Secondary|Pharmacokinetics: Maximum Plasma Concentration (Cmax)|Maximum observed FVIII activity, obtained directly from FVIII activity versus time data|Pre-infusion within 30 minutes; and post-infusion at 15 and 30 minutes, and 1, 3, 6, 9, 12, 24, 32, 48, 56, and 72 hours for both BAX 826 and ADVATE. BAX 826 will also include post-infusion at 96, 120, 144, and 168 hours.|In period 1 (ADVATE) the number of participants is 11,15,12 respectively for Cohorts 1, 2 and 3. In period 2 (BAX 826) the number of participants is 8, 10 and 11 respectively for cohorts 1, 2 and 3 (9 participants were excluded from the PK analysis for period 2).|||IU/dL||Geometric Coefficient of Variation|Geometric Mean
2557046|NCT02716194|Secondary|Pharmacokinetics: Volume of Distribution at Steady State (Vss)|Volume of distribution at steady state is calculated by MRT*CL MRT=Mean residence time CL=Clearance rate|Pre-infusion within 30 minutes; and post-infusion at 15 and 30 minutes, and 1, 3, 6, 9, 12, 24, 32, 48, 56, and 72 hours for both BAX 826 and ADVATE. BAX 826 will also include post-infusion at 96, 120, 144, and 168 hours.|In period 1 (ADVATE) the number of participants is 11,16,12 respectively for Cohorts 1, 2 and 3. In period 2 (BAX 826) the number of participants is 8, 10 and 11 respectively for cohorts 1, 2 and 3 (10 participants were excluded from the PK analysis for period 2).|||dL/kg||Geometric Coefficient of Variation|Geometric Mean
2557047|NCT02716194|Secondary|Pharmacokinetics: Incremental Recovery (IR)|Incremental recovery (IR) at Cmax, calculated as IR = (Cmax - Cpreinfusion) / Dose (IU/kg)|Pre-infusion within 30 minutes; and post-infusion at 15 and 30 minutes, and 1, 3, 6, 9, 12, 24, 32, 48, 56, and 72 hours for both BAX 826 and ADVATE. BAX 826 will also include post-infusion at 96, 120, 144, and 168 hours.|In period 1 (ADVATE) the number of participants is 11,15,12 respectively for Cohorts 1, 2 and 3. In period 2 (BAX 826) the number of participants is 8, 10 and 11 respectively for cohorts 1, 2 and 3 (9 participants were excluded from the PK analysis for period 2).|||(IU/dL)/(IU/kg)||Geometric Coefficient of Variation|Geometric Mean
2557048|NCT02716194|Secondary|Pharmacokinetics: Total Body Clearance (CL)|Systemic body clearance of drug from plasma, calculated by dose (IU/kg)/AUC0-∞|Pre-infusion within 30 minutes; and post-infusion at 15 and 30 minutes, and 1, 3, 6, 9, 12, 24, 32, 48, 56, and 72 hours for both BAX 826 and ADVATE. BAX 826 will also include post-infusion at 96, 120, 144, and 168 hours.|In period 1 (ADVATE) the number of participants is 11,16,12 respectively for Cohorts 1, 2 and 3. In period 2 (BAX 826) the number of participants is 8, 10 and 11 respectively for cohorts 1, 2 and 3 (10 participants were excluded from the PK analysis for period 2).|||dL/kg*h||Geometric Coefficient of Variation|Geometric Mean
2557049|NCT02716194|Secondary|Pharmacokinetics: Mean Residence Time (MRT)|Mean residence time, calculated as (AUMC 0-∞ / AUC 0-∞) - TI / 2, where TI is the time duration of infusion|Pre-infusion within 30 minutes; and post-infusion at 15 and 30 minutes, and 1, 3, 6, 9, 12, 24, 32, 48, 56, and 72 hours for both BAX 826 and ADVATE. BAX 826 will also include post-infusion at 96, 120, 144, and 168 hours.|In period 1 (ADVATE) the number of participants is 11,16,12 respectively for Cohorts 1, 2 and 3. In period 2 (BAX 826) the number of participants is 8, 10 and 11 respectively for cohorts 1, 2 and 3 (10 participants were excluded from the PK analysis for period 2).|||hours||Geometric Coefficient of Variation|Geometric Mean
2557050|NCT02716194|Secondary|Pharmacokinetics: Terminal Half-life (t1/2)|Terminal elimination phase half-life, calculated by (ln2)/lambda z, where lambda z is the terminal rate constant, determined by linear regression of the terminal points of the log-linear FVIII activity-time curve.|Pre-infusion within 30 minutes; and post-infusion at 15 and 30 minutes, and 1, 3, 6, 9, 12, 24, 32, 48, 56, and 72 hours for both BAX 826 and ADVATE. BAX 826 will also include post-infusion at 96, 120, 144, and 168 hours.|In period 1 (ADVATE) the number of participants is 11,16,12 respectively for Cohorts 1, 2 and 3. In period 2 (BAX 826) the number of participants is 8, 10 and 11 respectively for cohorts 1, 2 and 3 (10 participants were excluded from the PK analysis for period 2).|||hours||Geometric Coefficient of Variation|Geometric Mean
2557064|NCT02715726|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24: ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants from the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).|||percent change||Standard Error|Least Squares Mean
2561952|NCT02642952|Secondary|Carotid Radial Pulse Wave Velocity||2 months after surgery||||cm/seg||Standard Deviation|Mean
2557051|NCT02716194|Secondary|Pharmacokinetics: Area Under the Concentration-time Curve From 0 to Infinity (AUC0-∞)|Area under the FVIII activity-time curve from zero extrapolated to infinity, calculated by linear-up/log-down trapezoidal method and extrapolated to infinity, calculated as AUC last + C last / lambda z, where Clast is the estimated concentration at the last quantifiable time point|Pre-infusion within 30 minutes; and post-infusion at 15 and 30 minutes, and 1, 3, 6, 9, 12, 24, 32, 48, 56, and 72 hours for both BAX 826 and ADVATE. BAX 826 will also include post-infusion at 96, 120, 144, and 168 hours.|In period 1 (ADVATE) the number of participants is 11,16,12 respectively for Cohorts 1, 2 and 3. In period 2 (BAX 826) the number of participants is 8, 10 and 11 respectively for cohorts 1, 2 and 3 (10 participants were excluded from the PK analysis for period 2).|||IU*h/dL||Geometric Coefficient of Variation|Geometric Mean
2557052|NCT02716194|Primary|Immunogenicity: Human Anti-murine Antibodies (HAMA)|Binding antibodies HAMA (IgG)|Screening visit (Day -30 to -2); Advate Administration (Study Day 1) predose; ADVATE wash out period 96 hours to 4 weeks; BAX826 Administration Day 1 predose, and Post BAX826 Day 8; and study termination visit, week 6 ± 4 days||||Participants|||Count of Participants
2557053|NCT02716194|Primary|Immunogenicity: Anti-Chinese Hamster Ovary (Anti-CHO) Antibodies|Binding antibodies to CHO|Screening visit (Day -30 to -2); Advate Administration (Study Day 1) predose; ADVATE wash out period 96 hours to 4 weeks; BAX826 Administration Day 1 predose, and Post BAX826 Day 8; and study termination visit, week 6 ± 4 days|The immunogenicity analysis was performed on the participants of the safety population (participants who received at least one administration of BAX 826 or ADVATE) who have a predose and at least one postdose result.|||Participants|||Count of Participants
2557054|NCT02716194|Primary|Immunogenicity: Anti-polysialic Acid (Anti-PSA) Antibodies|Binding antibodies to PSA (IgG and IgM)|Screening visit (Day -30 to -2); Advate Administration (Study Day 1) predose; ADVATE wash out period 96 hours to 4 weeks; BAX826 Administration Day 1 predose, and Post BAX826 Day 8; and study termination visit, week 6 ± 4 days|The immunogenicity analysis was performed on the participants of the safety population (participants who received at least one administration of BAX 826 or ADVATE) who have a predose and at least one postdose result.|||Participants|||Count of Participants
2557055|NCT02716194|Primary|Immunogenicity: Binding Antibodies to Factor VIII (FVIII)|Binding antibodies to FVIII IgG and IgM|Screening visit (Day -30 to -2); Advate Administration (Study Day 1) predose; ADVATE wash out period 96 hours to 4 weeks; BAX826 Administration Day 1 predose, and Post BAX826 Day 8; and study termination visit, week 6 ± 4 days|The immunogenicity analysis was performed on the participants of the safety population (participants who received at least one administration of BAX 826 or ADVATE) who have a predose and at least one postdose result.|||Participants|||Count of Participants
2557056|NCT02716194|Primary|Immunogenicity: Binding Antibodies to PSA-FVIII (ie BAX 826)|Binding antibodies to PSA FVIII (ie BAX 826) IgG and IgM|Screening visit (Day -30 to -2); Advate Administration (Study Day 1) predose; ADVATE wash out period 96 hours to 4 weeks; BAX826 Administration Day 1 predose, and Post BAX826 Day 8; and study termination visit, week 6 ± 4 days|The immunogenicity analysis was performed on the participants of the safety population (participants who received at least one administration of BAX 826 or ADVATE) who have a predose and at least one postdose result.|||Participants|||Count of Participants
2557057|NCT02716194|Primary|Immunogenicity: Inhibitory Antibodies to Factor VIII (FVIII)|Inhibition of FVIII activity by antibodies binding to FVIII were measured using the Nijmegen modification of the Bethesda inhibitor assay.|Screening visit (Day -30 to -2); Advate Administration (Study Day 1) predose; ADVATE wash out period 96 hours to 4 weeks; BAX826 Administration Day 1 predose, and Post BAX826 Day 8; and study termination visit, week 6 ± 4 days|The immunogenicity analysis was performed on the participants of the safety population (participants who received at least one administration of BAX 826 or ADVATE) who have a predose and at least one postdose result.|||Participants|||Count of Participants
2557058|NCT02716194|Primary|Immediate Tolerability (Vital Signs and Clinical Laboratory Assessments)|Clinically significant results after treatment with investigational product that constitute an AE are counted. Vital signs include body temperature, respiratory rate, pulse rate, and blood pressure. Clinical laboratory results include: Hematology (hemoglobin, hematocrit, red blood cell count, white blood cell count with differential (i.e. basophils, eosinophils, lymphocytes, monocytes and neutrophils), international normalized ratio (INR), mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration (MCHC), platelet count. Clinical Chemistry: sodium, potassium, chloride, bicarbonate, total protein, albumin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, alkaline phosphatase, gamma-glutamyltransferase (GGT), blood urea nitrogen (BUN), creatinine, glucose. Lipid panel: cholesterol, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides|Screening (Day -30 to -2); Advate Administration (Study Day 1) pre & postdose, and Day 4; Advate washout 96 hours to 4 weeks; BAX826 Administration Day 1 pre & postdose, Post BAX826 Day 4, 8, 14, and 23; and study termination visit, week 6 ± 4 days||||Participants|||Count of Participants
2557059|NCT02716194|Primary|Serious AEs (SAEs) and Non-serious AEs Occurring After Infusion With BAX 826|Serious Adverse Events and non-serious Adverse Events the occurred after infusion with BAX 826.|Up to 6 weeks ± 4 days post infusion with BAX826.|Participants in Cohort 1, 2 and 3 in Period 2 (receiving BAX 826) are included.|||Adverse Events|||Number
2557060|NCT02715726|Secondary|Percent Change From Baseline in Apolipoprotein A-1 at Week 12 : ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 12|Apo A-1 ITT population.|||percent change||Standard Error|Least Squares Mean
2557061|NCT02715726|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12: ITT Analysis|Adjusted means and standard errors at Week 12 were obtained by using multiple imputation approach followed by a robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 12|ITT population.|||percent change||Standard Error|Mean
2557062|NCT02715726|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12: ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 12|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2561953|NCT02642952|Secondary|Carotid Radial Pulse Wave Velocity||before surgery||||cm/seg||Standard Deviation|Mean
2557065|NCT02715726|Secondary|Percent Change From Baseline in Fasting Triglycerides (TG) at Week 24: ITT Analysis|Adjusted means and standard errors at Week 24 were obtained by using multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2557066|NCT02715726|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 24: ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2557067|NCT02715726|Secondary|Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 24: ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model.|From Baseline to Week 24|ITT population.|||percent Change||Standard Error|Mean
2557068|NCT02715726|Secondary|Percentage of Participants Reaching Calculated Low Density Lipoprotein Cholesterol <70 mg/dL (1.81 mmol/L) at Week 24: On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).|Up to Week 24|mITT population.|||percentage of participants|||Number
2557069|NCT02715726|Secondary|Percentage of Participants Reaching Calculated Low Density Lipoprotein Cholesterol <70 mg/dL (1.81 mmol/L) at Week 24: ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 24|ITT population.|||percentage of participants|||Number
2557070|NCT02715726|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12: ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 12|Total-C ITT population|||percent Change||Standard Error|Least Squares Mean
2557071|NCT02715726|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 12: ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 12|Non-HDL-C ITT population.|||percent Change||Standard Error|Least Squares Mean
2557072|NCT02715726|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12: ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 12|Apo B ITT population.|||percent Change||Standard Error|Least Squares Mean
2557073|NCT02715726|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24: ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants from the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).|||percent Change||Standard Error|Least Squares Mean
2557074|NCT02715726|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).|From Baseline to Week 24|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).|||percent Change||Standard Error|Least Squares Mean
2557075|NCT02715726|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24: ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).|||percent Change||Standard Error|Least Squares Mean
2557076|NCT02715726|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 24: On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).|From Baseline to Week 24|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo B mITT population).|||percent Change||Standard Error|Least Squares Mean
2557077|NCT02715726|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24: ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).|||percent Change||Standard Error|Least Squares Mean
2557078|NCT02715726|Secondary|Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).|From Baseline to Week 12|mITT population.|||percent change||Standard Error|Least Squares Mean
2557079|NCT02715726|Secondary|Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 12|ITT population.|||percent change||Standard Error|Least Squares Mean
2557080|NCT02715726|Secondary|Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population included all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2557081|NCT02715726|Primary|Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: Intent-to-treat (ITT) Analysis|Adjusted least square (LS) means and standard errors at Week 24 were obtained from mixed models analysis with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population included all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2557082|NCT02715700|Primary|Tmax of Total Methadone|The Tmax of total methadone was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose on Day 1 and Day 6|All treated participants are included.|||Hours||Full Range|Median
2557083|NCT02715700|Primary|Cmax of Total Methadone|The Cmax of total methadone was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose on Day 1 and Day 6|All treated participants are included.|||ng/mL/mg||95% Confidence Interval|Geometric Mean
2557084|NCT02715700|Primary|C24 of Total Methadone|The C24 of total methadone was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.|24 hours postdose on Day 1 and Day 6|All treated participants are included.|||ng/mL/mg||95% Confidence Interval|Geometric Mean
2557085|NCT02715700|Primary|AUC0-24 of Total Methadone|The AUC0-24 of total methadone was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose on Day 1 and Day 6|All treated participants are included.|||ng*hr/mL/mg||95% Confidence Interval|Geometric Mean
2557086|NCT02715700|Primary|Tmax of S-Methadone|The Tmax of the S- methadone enantiomer was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose on Day 1 and Day 6|All treated participants are included.|||Hours||Full Range|Median
2557087|NCT02715700|Primary|Cmax of S-Methadone|The Cmax of the S- methadone enantiomer was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose on Day 1 and Day 6|All treated participants are included.|||ng/mL/mg||95% Confidence Interval|Geometric Mean
2557088|NCT02715700|Primary|C24 of S-Methadone|The C24 of the S- methadone enantiomer was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.|24 hours postdose on Day 1 and Day 6|All treated participants are included.|||ng/mL/mg||95% Confidence Interval|Geometric Mean
2557089|NCT02715700|Primary|AUC0-24 of S-Methadone|The AUC0-24 of the S- methadone enantiomer was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose on Day 1 and Day 6|All treated participants are included.|||ng*hr/mL/mg||95% Confidence Interval|Geometric Mean
2557090|NCT02715700|Primary|Time to Maximum Plasma Concentration (Tmax) of R-Methadone|The Tmax of the R- methadone enantiomer was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose on Day 1 and Day 6|All treated participants are included.|||Hours||Full Range|Median
2561954|NCT02642952|Secondary|Central Blood Pressure||before surgery||||mmHg||Standard Deviation|Mean
2561955|NCT02642952|Primary|AIx@75|Augmentation Index corrected to 75 bpm|2 months after Surgery||||percentage||Standard Deviation|Mean
2557091|NCT02715700|Primary|Maximum Plasma Concentration (Cmax) of R-Methadone|The Cmax of the R- methadone enantiomer was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose on Day 1 and Day 6|All treated participants are included.|||ng/mL/mg||95% Confidence Interval|Geometric Mean
2557092|NCT02715700|Primary|Plasma Concentration at 24 Hours After Dosing (C24) of R-Methadone|The C24 of the R- methadone enantiomer was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by LC-MS/MS detection. The LLoQ was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.|24 hours postdose on Day 1 and Day 6|All treated participants are included.|||ng/mL/mg||95% Confidence Interval|Geometric Mean
2557093|NCT02715700|Primary|Area Under the Concentration-Time Curve From Zero to 24 Hours After Dosing (AUC0-24) of R-Methadone|The AUC0-24 of the R- methadone enantiomer was determined on Day 1 (methadone alone) and on Day 6 (methadone + doravirine). Plasma samples collected for methadone assay were analyzed for R- and S-methadone concentrations by Pharma Medica Research Inc. (Ontario, Canada). The analytical method used liquid-liquid extraction for analyte isolation followed by liquid chromatographic-tandem mass spectrometric (LC-MS/MS) detection. The lower limit of quantification (LLoQ) was 0.0250 ng/mL for each enantiomer. The analytical range was 0.0250 - 15.0 ng/mL.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose on Day 1 and Day 6|All treated participants are included.|||ng*hr/mL/mg||95% Confidence Interval|Geometric Mean
2557094|NCT02714868|Secondary|Readiness for Advocacy|readiness to engage in advocacy based on transtheoretical model of change. This is a single question with a 5 possible responses (1= minimum, 5= maximum), where higher responses (5) indicate higher readiness for advocacy. Data is reported as increase (improvement in readiness), no change, or decrease (decline in readiness). Improvement is a better outcome. Below, reported for number of participants in each group with improvement between intake and 12 weeks following intake (outcome).|intake, 12 weeks following intake (outcome)||||Participants|||Count of Participants
2557095|NCT02714868|Secondary|Participation and Environment Measure for Children and Youth (PEM-CY)|"Frequency of participation in home, school, and the community. Parent report. We examined change in scores between baseline and outcome only for the context in which the individuals' goal occurred (e.g., for GAS goals regarding going to a concert, the parent only completed community at outcome. Higher scores indicate higher frequency of participation. Below, we only report outcomes for the youth with community data at outcome, as it was the most frequently occurring goal context . 0 is do not ever participate, and 7 is participate daily. HIgher scores indicate more frequent participation in the context"|intake, 12 weeks following intake (outcome)|This is the number of youth who completed the community context participation frequency scores at outcome because the identified participation goal (see GAS outcome measure) occurred in the community context.|||units on a scale||Standard Deviation|Mean
2557096|NCT02714868|Primary|Generalized Self Efficacy Scale (GSES)|We revised a disability self-efficacy scale for this study and created additional questions to assess self-efficacy for addressing environmental barriers. We used a modified three point response scale (Not like me, Sort of like me, Really like me) that incorporated visuals to support comprehension. Higher scores indicated higher self-efficacy. Sum scores range from minimum 11 to maximum 33.|intake, 12 weeks following intake (outcome), 18 weeks following intake (6 week follow up)|Some participants (4.9%) were not attending school, and therefore did not complete questions about school. To avoid imputing data not missing at random, we dropped these participants from the analyses of the GSES which included school items.|||scores on a scale||Standard Deviation|Mean
2557097|NCT02714868|Primary|AIR Self-Determination Scale (American Institutes on Research- AIR)|The AIR measured the capacity and opportunity to act in a self-determined manner at home and school. Parallel youth and parent forms used a 5-point frequency scale (never-always), with higher scores reflecting more self-determination. Reported here are parent self-reported sum scores at outcome. Sum scores range from minimum 18- to maximum 90 (90/higher scores = more self determination)|intake, 12 weeks following intake (outcome), 18 weeks following intake (6 week follow up)|Some participants (4.9%) were not attending school, and therefore did not complete questions about school. To avoid imputing data not missing at random, we dropped these participants from the analyses of the AIR which included school items.|||scores on a scale||Standard Deviation|Mean
2557098|NCT02714868|Primary|Project TEAM Knowledge Test|"Part I: Knowledge of parts of the environment, modification strategies, and the Game Plan. Higher scores indicate more correct responses.~Part I responses were independently coded as correct/incorrect by the study facilitator and a trained graduate student; discrepancies were resolved by a third scorer (the PI). To establish unidimensionality, we applied a dichotomous Rasch model and removed 24% of the items with Outfit Mean Square >2; values higher than 2 can indicate guessing. The resulting interval sum scores, in logits, were used for analysis; higher logit scores indicate more knowledge (Minimum: -4.05 to maximum 6.69). Higher scores indicate greater problem solving."|intake, 12 weeks following intake (outcome), 18 weeks following intake (6 week follow up)|We did not analyze 5 youth on this measure in the intervention group: 2 were withdrawn by PI, and 3 withdrew from study. An additional participant had all missing data for this measure at all time points|||scores on a test||Standard Deviation|Mean
2557099|NCT02714868|Primary|Goal Attainment Scaling (GAS)|All youth had four goals in the following areas: 1) a participation goal, 2) their ability to identify environmental barriers to their goal, 3) their ability to generate solutions to barriers, and 4) their ability to advocate for needed changes to achieve their goal. Each goal used a five-point goal attainment scale with baseline at -1. Goals levels were created at intake (initial assessment). For the knowledge application goals (goal 2-4), we created standardized goal levels to ensure content validity and reliability within and across youth. Goal attainment for all four goals was rated 12 weeks following intake (outcome) and transformed into a t-score. A t-score of 50 indicates all goals were achieved at the expected level; t-scores greater than 50 indicate individuals exceeded the expected level of goal attainment. Scores range from 0-100 (100 indicates greater than expected goal attainment).|12 weeks following intake (outcome)|We did not score GAS for withdrawn Project TEAM participants.|||t-score||Standard Deviation|Mean
2557101|NCT02714426|Other Pre-specified|Self-ratings on Cognitive and Affective Mindfulness Scale (CAMSr) Over 14 Weekly Measurements|Cognitive and Affective Mindfulness Scale (CAMSr) will be computer administered. It is a psychological measurement to explore mindfulness. Each week ten items are rated on a 4-point Likert-type scale (1=rarely/never, 2=sometimes, 3=often, 4=almost always). Higher scores indicate greater cognitive and emotional focus. Scores are the average of the ten items, normalized and converted to T-score (mean=50, standard deviation = 10, minimum = 0, maximum = 100, higher = better) metric.|Self-ratings weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14|Intent to treat analysis via mixed effects modeling; all available data were used at each occasion. Participants were not able to attend all sessions.|||units on a scale||Standard Deviation|Mean
2557102|NCT02714426|Other Pre-specified|Self-ratings in Anxiety (GAD-7) Questionnaire Over 14 Weekly Measurements|Participants will answer computer 7 administered questions about anxiety in the past week. Score is a Likert-type scale response from the following scale: 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Scores have been normalized via Blom transformation and computed to T-score metric (mean=50, standard deviation = 10, minimum = 0, maximum = 100, higher = worse)|Self-ratings in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14|Intent to treat analysis via mixed effects modeling; all available data were used at each occasion. Participants were not able to attend all sessions.|||units on a scale||Standard Deviation|Mean
2557103|NCT02714426|Other Pre-specified|Self-ratings of Perceived Mind Wandering Over 8 Weekly Measurements|Participants in both arms are asked, at the end of each of their eight intervention sessions, to focus on breathing. They are interrupted five times during this breathing exercise and asked what proportion of their attention (0-100) was wandering off the breathing task. Score is the average proportion of self-rated mind-wandering over five probes. Scores have been normalized via Blom transformation and computed to T-score metric (mean=50, standard deviation = 10, minimum = 0, maximum = 100, higher = worse)|Self-ratings of weeks 4, 5, 6, 7, 8, 9, 10, 11|Intent to treat analysis via mixed effects modeling; all available data were used at each occasion. Participants were not able to attend all sessions.|||units on a scale||Standard Deviation|Mean
2557104|NCT02714426|Secondary|Performance in Stroop Interference Over 14 Weekly Measurements|This task set is computerized presents participants with a word (red or green or blue) that may be presented in (a) congruent (same) color as the word itself (e.g., red word is printed in red), or (b) incongruent (word red printed in green or blue). Participants are cued to either select the word or the color, this varies from trial to trial. Score is the reaction time difference between correct responses to congruent and incongruent stimuli. Scores have been normalized via Blom transformation and computed to T-score metric (mean=50, standard deviation = 10, minimum = 0, maximum = 100, higher = worse)|Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14|Intent to treat analysis via mixed effects modeling; all available data were used at each occasion. Participants were not able to attend all sessions.|||units on a scale||Standard Deviation|Mean
2557105|NCT02714426|Secondary|Performance in Useful Field of View Over 14 Weekly Measurements|The useful field of view task is a computer-administered selective visual attention test that determines the minimum presentation time needed (between 16-500 msec) to correctly make two visual judgments: (a) is a centrally presented line drawing of a car or truck? and (b) where on the screen is a peripheral car located? Score is the fastest presentation time at which participants achieve at least 75% accuracy. Scores have been normalized via Blom transformation and computed to T-score metric (mean=50, standard deviation = 10, minimum = 0, maximum = 100, higher = worse)|Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14|Intent to treat analysis via mixed effects modeling; all available data were used at each occasion. Participants were not able to attend all sessions.|||units on a scale||Standard Deviation|Mean
2557106|NCT02714426|Primary|Performance in Attention Network Task Conflict Monitoring Over 14 Weekly Measurements|The Attention Network Task is a computerized test that measures three different components of attention (alerting, orienting, and conflict monitoring). Score is the computed as the difference between reaction time on correct trials in cued and uncued conditions. Scores have been normalized via Blom transformation and computed to T-score metric (mean=50, standard deviation = 10, minimum = 0, maximum = 100, higher = worse)|Performance in weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14|Intent to treat analysis via mixed effects modeling; all available data were used at each occasion. Participants were not able to attend all sessions.|||units on a scale||Standard Deviation|Mean
2557107|NCT02714400|Secondary|Sleep Efficiency|Change from baseline in sleep efficiency after single dose of Venlafaxine will be estimated using overnight polysomnography.|Baseline and 7-day follow up||||Percent Time in Bed||Standard Deviation|Mean
2557108|NCT02714400|Secondary|Arousal Threshold|Change from baseline in respiratory arousal threshold after single dose of Venlafaxine will be estimated.|Baseline and 7-day follow up|In one subject arousal threshold could not be quantified.|||Percent V-eupnea||Inter-Quartile Range|Median
2557109|NCT02714400|Secondary|Loop Gain|Loop gain 1 is used to describe the stability of ventilatory control. The change from baseline in loop gain after a single dose of Venlafaxine will be estimated.|Baseline and 7-day follow up|In one subject loop gain could not be quantified.|||Dimensionless||Standard Deviation|Mean
2557110|NCT02714400|Primary|Nadir Oxygen Level During Sleep|Change from baseline in nadir oxygen level during sleep after a single dose of Venlafaxine will be evaluated using overnight polysomnography. A lower blood oxygen saturation during sleep is associated with a more severe obstructive sleep apnea.|Baseline and 7-day follow up||||Percent Oxygen Saturation||Inter-Quartile Range|Median
2557111|NCT02714400|Primary|The Apnea Hypopnea Index|The Apnea hypopnea index is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The change from baseline in apnea hypopnea index after a single dose of Venlafaxine will be evaluated using overnight polysomnography. An apnea hypopnea index less than five events per hour is considered within normal limits.|Baseline and 7-day follow up||||Events per Hour of Sleep||Standard Deviation|Mean
2557112|NCT02714283|Secondary|Arrhythmia|Arrhythmia (principal diagnosis)|up to 8 years||||events|person-years||Number
2557113|NCT02714283|Secondary|Hemoptysis|Hemoptysis event|up to 8 years||||Events|Patient-years||Number
2557114|NCT02714283|Secondary|All-cause Hospitalization|All-cause hospitalization.|up to 8 years||||Events|Patient-years||Number
2557115|NCT02714283|Secondary|All-cause Mortality|All-cause mortality.|up to 8 years||||Events|Patient-years||Number
2557122|NCT02714218|Secondary|Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain|Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Pain sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms;lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points|Weeks 7, 16, 20, 24, 28, 32, 36, 40|All treated participants|||Scores on a scale||Standard Deviation|Mean
2557123|NCT02714218|Secondary|Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea and Vomiting|Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Nausea and Vomiting sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms;lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points for the various scales of the EORTC QLQ-C30|Weeks 7, 16, 20, 24, 28, 32, 36, 40|All treated participants|||Scores on a scale||Standard Deviation|Mean
2557124|NCT02714218|Secondary|Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue|Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Fatigue sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms;lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points|Weeks 7, 16, 20, 24, 28, 32, 36, 40|All treated participants|||Scores on a scale||Standard Deviation|Mean
2557125|NCT02714218|Secondary|Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties|Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Financial difficulties sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms;lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points|Weeks 7, 16, 20, 24, 28, 32, 36, 40|All treated participants|||Scores on a scale||Standard Deviation|Mean
2557126|NCT02714218|Secondary|Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea|Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Diarrhea sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms;lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.|Weeks 7, 16, 20, 24, 28, 32, 36, 40|All treated participants|||Scores on a scale||Standard Deviation|Mean
2557127|NCT02714218|Secondary|Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation|Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Constipation sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms;lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points|Weeks 7, 16, 20, 24, 28, 32, 36, 40|All treated participants|||Scores on a scale||Standard Deviation|Mean
2557128|NCT02714218|Secondary|Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss|Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Appetite loss sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms;lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.|Weeks 7, 16, 20, 24, 28, 32, 36, 40|All treated participants|||Scores on a scale||Standard Deviation|Mean
2557129|NCT02714218|Secondary|Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia|Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Insomnia sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms;lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.|Weeks 7, 16, 20, 24, 28, 32, 36, 40|All treated participants|||Scores on a scale||Standard Deviation|Mean
2557130|NCT02714218|Secondary|Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea|Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Dyspnea sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms;lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.|Weeks 7, 16, 20, 24, 28, 32, 36, 40|All treated participants|||Scores on a scale||Standard Deviation|Mean
2557147|NCT02714062|Secondary|Change in Visual Analog Scale (VAS) Satiety Scores|"Mean change in visual analog scale (VAS) satiety scores from baseline to Day 56. VAS satiety score is measured using a 10.0 cm horizontal line. The left end of this line is defined by word descriptors very satisfied and corresponds to a VAS satiety score of 0.0. The right end of this line is defined by word descriptors not all at satisfied and corresponds to a VAS satiety score of 10.0. Subjects were asked Please mark with a perpendicular line on the scale how satisfied you were after eating during the past week: to evaluate how satisfied subjects are after eating during the past week. Research staff measure the distance between the 0.0 = very satisfied anchor and the mark made by the subject (length to the nearest tenth of a centimeter) to score the measure."|56 days|The number of subjects with values at both time points (Baseline and Day 56)|||units on a scale||Standard Deviation|Mean
2557131|NCT02714218|Secondary|Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health Status|Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The EORTC QLQ-C30 comprises 6 functional scales (role function, physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Weeks 7, 16, 20, 24, 28, 32, 36, 40|All treated participants|||Scores on a scale||Standard Deviation|Mean
2557132|NCT02714218|Secondary|Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Scale|Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The EORTC QLQ-C30 comprises 6 functional scales (role function, physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Weeks 7, 16, 20, 24, 28, 32, 36, 40|All treated participants|||Scores on a scale||Standard Deviation|Mean
2557133|NCT02714218|Secondary|Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Scale|Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The EORTC QLQ-C30 comprises 6 functional scales (role function, physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Weeks 7, 16, 20, 24, 28, 32, 36, 40|All treated participants|||Scores on a scale||Standard Deviation|Mean
2557134|NCT02714218|Secondary|Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Scale|Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The EORTC QLQ-C30 comprises 6 functional scales (role function, physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Weeks 7, 16, 20, 24, 28, 32, 36, 40|All treated participants|||Scores on a scale||Standard Deviation|Mean
2557135|NCT02714218|Secondary|Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Scale|Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The EORTC QLQ-C30 comprises 6 functional scales (role function, physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Weeks 7, 16, 20, 24, 28, 32, 36, 40|All treated participants|||Scores on a scale||Standard Deviation|Mean
2557136|NCT02714218|Secondary|Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale|Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The EORTC QLQ-C30 comprises 6 functional scales (role function, physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Weeks 7, 16, 20, 24, 28, 32, 36, 40|All treated participants|||Scores on a scale||Standard Deviation|Mean
2557188|NCT02713243|Secondary|Total Dose of Rescue Medication Used at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined|Total Dose of Rescue Medication used at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined; Rescue Medication used was loperamide|Baseline, Week 1 (Period 1 & 2), Week 2 (Period 1 & 2), Week 1 & 2 combined|Safety analysis set consists of 20 patients(10 pts per treatment period),17 &19 patients received at least 1 LJN & 1 Placebo dose, respectively, therefore 17 pts in the LJN452 &19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.|||mg||Standard Deviation|Mean
2557137|NCT02714218|Secondary|Median Progression Free Survival (PFS)|PFS is defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on their date of randomization. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy|Date of randomization to first date of documented progression or death due to any cause, whichever occurs first (assessed up to April 2017, approximately 12 months)|All treated participants|||Months||95% Confidence Interval|Median
2557138|NCT02714218|Secondary|Rate of Progression Free Survival (PFS) at 6 Months|PFS is defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death. Particpants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on their date of randomization. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy|6 months|All treated participants|||Percentage of participants||95% Confidence Interval|Number
2557139|NCT02714218|Secondary|Median Overall Survival|OS is defined as the time between the date of randomization and the date of death due to any cause. The results here do not account for any censoring of the data. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug|From date of randomization to date of death due to any cause (assessed up to April 2018, approximately 20 months)|All treated participants|||Months||95% Confidence Interval|Median
2557140|NCT02714218|Secondary|Overall Survival (OS) Rate|OS is defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to October 2018, approximately 28 months|All treated participants|||Percentage of Participants||95% Confidence Interval|Number
2557141|NCT02714218|Secondary|Objective Response Rate (ORR)|The ORR was defined as the number of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of treated participants for each arm. The BOR was defined as the best response designation, as determined by the Investigator, recorded between the date of randomization and the date of progression, as assessed by the Investigator per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurred first. For participants without evidence of RECIST 1.1 progression or subsequent anticancer therapy, all available response designations contributed to the BOR assessment. Tumor assessments are scheduled to be performed at Week 12 following randomization, every 8 weeks for the first 12 months and then every 12 weeks until disease progression|From date of randomization to date of objectively documented progression per RECIST 1.1 or the date of subsequent anti-cancer therapy, whichever occurs first (assessed up to April 2018, approximately 20 months)|All treated participants|||Percentage of participants||95% Confidence Interval|Number
2557142|NCT02714218|Primary|Percentage of Participants With Drug-related Grade 3 - 5 Adverse Events (AEs)|The drug-related Grade 3 - 5 AE rate was defined as number of participants who experienced at least 1 AE of Grade 3 or higher, judged to be related to study drug by the investigator, and with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment, divided by number of treated participants. AE grade was defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria|After first dose of study treatment and within 30 days of the last dose of study treatment|All treated participants|||Percentage of participants||95% Confidence Interval|Number
2557143|NCT02714062|Secondary|Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)|Mean changes in glycemic parameters [Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)] from baseline to Day 56. The Oral Glucose Tolerance Test (OGTT) were performed at Baseline and Day 56 using 75 g oral glucose load; blood samples were obtained at baseline and at 2 hours post glucose load for evaluation of both glucose and insulin levels. Insulin Sensitivity was measured by obtaining glucose and insulin levels in a fasting state and at 2 hours after administration of oral glucose load. Matsuda index = 10,000/SQRT [glucose concentration (mg/dL) (fasting)*insulin concentration (uIU/mL) (fasting)*glucose concentration (mg/dL) (2 hours after glucose load)*insulin concentration (uIU/mL) (2 hours after glucose load)], with higher numbers indicating better insulin sensitivity.|56 days|The number of subjects with values at both time points (Baseline and Day 56)|||Index||Standard Deviation|Mean
2557144|NCT02714062|Secondary|Change in HOMA-IR|Mean changes in glycemic parameters (HOMA-IR) from baseline to Day 56|56 days|The number of subjects with values at both time points (Baseline and Day 56)|||μIU/mL||Standard Deviation|Mean
2557145|NCT02714062|Primary|Maximum Concentration (Cmax) of Topiramate|A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.|On Days 14, 28, 42, and 56|PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.|||μg/mL||Standard Deviation|Mean
2557146|NCT02714062|Primary|Area Under the Curve (AUC) of Topiramate|A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state.|On Days 14, 28, 42, and 56|PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.|||μg•h/mL||Standard Deviation|Mean
2557189|NCT02713243|Secondary|Time to Reach Maximum Concentration After Drug Administration (Tmax)|Tmax is the time to reach the maximum concentration after drug administration [time]|Day 1 (Period 1 & 2) and Day 12 (Period 1 & 2)|PK analysis set: Patients with at least one valid PK concentration measurement and no major protocol deviations affecting PK; No statistical Analysis|||hr||Full Range|Median
2557148|NCT02714062|Secondary|Change in Visual Analog Scale (VAS) Hunger Scores|"Mean change in visual analog scale (VAS) hunger scores from baseline to Day 56. VAS hunger score is measured using a 10.0 cm horizontal line. The left end of this line is defined by word descriptors not at all hungry and corresponds to a VAS hunger score of 0.0. The right end of this line is defined by word descriptors extremely hungry all the time and corresponds to a VAS hunger score of 10.0. Subjects were asked Please mark with a perpendicular line on the scale how hungry you were overall during the past week: to best describes their overall level of hunger during the past week. Research staff measure the distance between the 0.0 = not at all hungry anchor and the mark made by the subject (length to the nearest tenth of a centimeter) to score the measure."|56 days|The number of subjects with values at both time points (Baseline and Day 56)|||units on a scale||Standard Deviation|Mean
2557149|NCT02714062|Secondary|Change in Lipid Parameters|Mean percent changes in lipid parameters, including total cholesterol, LDL-C, HDL-C and triglycerides (TG) from baseline to Day 56|56 days|The number of subjects with values at both time points (Baseline and Day 56)|||Percent Change||Standard Deviation|Mean
2557150|NCT02714062|Secondary|Change in OGTT of Fasting and 2-hour Glucose|Mean changes in glycemic parameters (OGTT of fasting and 2-hour glucose) from baseline to Day 56|56 days|The number of subjects with values at both time points (Baseline and Day 56)|||mg/dL||Standard Deviation|Mean
2557151|NCT02714062|Secondary|Change in Blood Pressure|Mean change in blood pressure from baseline to Day 56|56 days|The number of subjects with values at both time points (Baseline and Day 56)|||mmHg||Standard Deviation|Mean
2557152|NCT02714062|Secondary|Change in Waist Circumference|Mean change in waist circumference from baseline to Day 56|56 days|The number of subjects with values at both time points (Baseline and Day 56)|||cm||Standard Deviation|Mean
2557153|NCT02714062|Secondary|Weight Loss|Mean percent weight change from baseline to Day 56|56 days|The number of subjects with values at both time points (Baseline and Day 56)|||Percent weight change||Standard Deviation|Mean
2557154|NCT02714062|Primary|Maximum Concentration (Cmax) of Phentermine|A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.|On Days 14, 28, 42, and 56|PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.|||ng/mL||Standard Deviation|Mean
2557155|NCT02714062|Primary|Area Under the Curve (AUC) of Phentermine|A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state.|On Days 14, 28, 42, and 56|PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.|||ng•h/mL||Standard Deviation|Mean
2557156|NCT02714062|Primary|Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate|A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.|On Days 14, 28, 42, and 56|PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.|||L||Standard Deviation|Mean
2557157|NCT02714062|Primary|Apparent Clearance (CL/F) of Phentermine and Topiramate|A Bayesian analysis was performed to derive posterior Bayes individual pharmacokinetic (PK) parameters.|On Days 14, 28, 42, and 56|PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.|||L/h||Standard Deviation|Mean
2557158|NCT02713828|Secondary|Overall Survival (OS)|OS assessed in accordance with RECIST 1.1.|23 months||||months||95% Confidence Interval|Median
2557159|NCT02713828|Secondary|Progression-Free Survival (PFS)|PFS assessed in accordance with RECIST 1.1.|23 months||||months||95% Confidence Interval|Median
2557160|NCT02713828|Secondary|Duration of Objective Response (DOR)|DOR assessed in accordance with RECIST 1.1.|23 months|1 patient achieved partial response. The duration of this patient’s response is at least 9.4 months, with response ongoing at the time of final report.|||months|||Number
2557161|NCT02713828|Secondary|Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0.|To further characterize the safety of glembatumumab vedotin by the number of participants with abnormal laboratory values and/or adverse events related to treatment (including Serious Adverse Events and Other Adverse Events).|23 months||||Participants|||Count of Participants
2557162|NCT02713828|Primary|Phase II: Objective Response Rate (ORR)|Determine the anti-tumor activity, as assessed by ORR in accordance with RECIST 1.1, of the MTD of glembatumumab vedotin in patients with advanced gpNMB-expressing SCC of the lung.|40 months|The study terminated early during the phase I portion of the trial||||||
2557163|NCT02713828|Primary|Phase I: Determine Maximum Tolerated Dose (MTD)|To determine the Maximum Tolerated Dose (MTD) by number of participants with DLTs.|42 (±3) days||||mg/kg|||Number
2557164|NCT02713789|Secondary|"Mean Change From Baseline in the Percentage of Yes Responses to Questions 1, 4, and 5 of the Sexual Encounter Profile (SEP) at Week 24"|"SEP is a diary in which participants record each sexual attempt made throughout the study and is composed of 5 questions assessing sexual function. Question 1: Were you able to achieve at least some erection?; Question 4: Were you satisfied with the hardness of your erection?; Question 5: Overall, were you satisfied with the sexual experience? The number of yes response to each question in the SEP was computed as (Sum of all yes responses to respective SEP question /Total number of responses to that SEP question)*100. Change from Baseline was calculated as the post-Baseline value minus the Baseline value."|Baseline; Week 24|mITT Population|||percentage of responses||95% Confidence Interval|Mean
2557165|NCT02713789|Secondary|Change From Baseline in the Overall Sexual Satisfaction Domain of the International Index of Erectile Function (IIEF) at Week 24|The IIEF is a validated, self-administered questionnaire that is a valid measure of male erectile dysfunction. The test contains 15 questions in 5 domains: (1) Erectile duration/function (questions 01 to 05 and 15); (2) Orgasmic function (questions 09 and 10); (3) Sexual desire (questions 11 and 12); (4) Intercourse satisfaction (questions 06, 07, and 08); (5) Overall sexual satisfaction (questions 13 and 14). The domain-specific scores were calculated as the sum of the scores of the questions in the respective domain; thus, the total score of the Overall Sexual Satisfaction domain was the sum of 2 questions. Score range: 1 to 5 (Q13 and Q14). Total score: 2 to 10. Higher scores reflect better erectile function. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.|Baseline; Week 24|mITT Population. Only those participants with data available were analyzed.|||score on a scale||Standard Error|Mean
2557166|NCT02713789|Secondary|Change From Baseline in the Intercourse Satisfaction Domain of the International Index of Erectile Function (IIEF) at Week 24|The IIEF is a validated, self-administered questionnaire that is a valid measure of male erectile dysfunction. The test contains 15 questions in 5 domains: (1) Erectile duration/function (questions 01 to 05 and 15); (2) Orgasmic function (questions 09 and 10); (3) Sexual desire (questions 11 and 12); (4) Intercourse satisfaction (questions 06, 07, and 08); (5) Overall sexual satisfaction (questions 13 and 14). The domain-specific scores were calculated as the sum of the scores of the questions in the respective domain; thus, the total score of the Intercourse Satisfaction domain was the sum of 3 questions. Score range: 0 to 5 (Q06 through Q8). Total score: 0 to 15. Higher scores reflect better erectile function. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.|Baseline; Week 24|mITT Population. Only those participants with data available were analyzed.|||score on a scale||Standard Error|Mean
2557167|NCT02713789|Secondary|Change From Baseline in the Sexual Desire Domain of the International Index of Erectile Function (IIEF) at Week 24|The IIEF is a validated, self-administered questionnaire that is a valid measure of male erectile dysfunction. The test contains 15 questions in 5 domains: (1) Erectile duration/function (questions 01 to 05 and 15); (2) Orgasmic function (questions 09 and 10); (3) Sexual desire (questions 11 and 12); (4) Intercourse satisfaction (questions 06, 07, and 08); (5) Overall sexual satisfaction (questions 13 and 14). The domain-specific scores were calculated as the sum of the scores of the questions in the respective domain; thus, the total score of the Sexual Desire domain was the sum of 2 questions. Score range: 1 to 5 (Q11 and Q12). Total score: 2 to 10. Higher scores reflect better erectile function. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.|Baseline; Week 24|mITT Population. Only those participants with data available were analyzed.|||score on a scale||Standard Error|Mean
2557168|NCT02713789|Secondary|Change From Baseline in the Orgasmic Function Domain of the International Index of Erectile Function (IIEF) at Week 24|The IIEF is a validated, self-administered questionnaire that is a valid measure of male erectile dysfunction. The test contains 15 questions in 5 domains: (1) Erectile duration/function (questions 01 to 05 and 15); (2) Orgasmic function (questions 09 and 10); (3) Sexual desire (questions 11 and 12); (4) Intercourse satisfaction (questions 06, 07, and 08); (5) Overall sexual satisfaction (questions 13 and 14). The domain-specific scores were calculated as the sum of the scores of the questions in the respective domain; thus, the total score of the Orgasmic Function domain was the sum of 2 questions. Score range: 0 to 5 (Q09 and Q10). Total score: 0 to 10. Higher scores reflect better erectile function. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.|Baseline; Week 24|mITT Population. Only those participants with data available were analyzed.|||score on a scale||Standard Error|Mean
2557169|NCT02713789|Secondary|Change From Baseline in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) at Week 24|The IIEF is a validated, self-administered questionnaire that is a valid measure of male erectile dysfunction. The test contains 15 questions in 5 domains: (1) Erectile duration/function (questions [Q] 01 to 05 and 15); (2) Orgasmic function (questions 09 and 10); (3) Sexual desire (questions 11 and 12); (4) Intercourse satisfaction (questions 06, 07, and 08); (5) Overall sexual satisfaction (questions 13 and 14). The EF domain has been validated to assess erectile changes only. The domain-specific scores were calculated as the sum of the scores of the questions in the respective domain; thus, the total score of the EF domain was the sum of the 6 questions. Score range: 0 to 5 (Q01 to Q05), 1 to 5 (Q15). Total score: 1 to 30. Higher scores reflect better erectile function. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.|Baseline; Week 24|mITT Population. Only those participants with data available were analyzed.|||score on a scale||Standard Error|Mean
2557170|NCT02713789|Secondary|"Mean Change From Baseline in the Percentage of Yes Responses to Questions 2 and 3 of the Sexual Encounter Profile (SEP) at Week 24"|"SEP is a diary in which participants record each sexual attempt made throughout the study and is composed of 5 questions assessing sexual function. Two questions from the SEP deal with the ability to achieve vaginal penetration (Question 2: Were you able to insert your penis into your partner's vagina?), and the ability to maintain an erection (Question 3: Did your erection last long enough for you to have successful intercourse?). The number of yes response to each question in the SEP was computed as (Sum of all yes responses to respective SEP question /Total number of responses to that SEP question)*100. Change from Baseline was calculated as the post-Baseline value minus the Baseline value."|Baseline; Week 24|Modified Intent-to-Treat (mITT) Population: all participants in the Intent-to-Treat (ITT) Population (all participants who were randomized to either of the treatment groups and who received at least one dose of study treatment) who had at least one post-dose efficacy assessment|||percentage of responses||95% Confidence Interval|Mean
2557171|NCT02713789|Primary|Number of Participants With Significant Changes on the Cardiogram as Measured by Significant Prolongation of QT Intervals and Cardiac Rhythm|Clinical significance was determined by the Investigator using central laboratory values.|up to Week 24 ± 3 days|Safety Population|||Participants|||Count of Participants
2557172|NCT02713789|Primary|Number of Participants With Significant Changes in Clinical Laboratory Parameters as Measured on Interval Blood and Urine Tests|Clinical significance was determined by the Investigator using central laboratory values.|up to Week 24 ± 3 days|Safety Population|||Participants|||Count of Participants
2557173|NCT02713789|Primary|Number of Participants With Adverse Experiences as Measured by Changes in Physical Examination of the Penis|Physical examination of the penis included inspection and palpation.|up to Week 24 ± 3 days|Safety Population: all participants who were randomized to any of the treatment groups and who have received at least one dose of study treatment|||Participants|||Count of Participants
2557174|NCT02713698|Primary|Plasma Propofol Concentration (mcg/mL)|"Arterial blood samples were obtained after LOC and every 20-30 minutes during propofol infusion. After stopping propofol infusion, arterial blood samples were obtained immediately after recovery of consciousness.~At the end of the surgery arterial blood samples were centrifuged at 2862xg for 5 minutes and they were preserved at -80ºC until analysis.~The quantification of propofol in serum was performed using gas chromatography/ion trap-mass spectrometry (GC/IT-MS)"|up to 2 hours||||mcg/mL||Standard Deviation|Mean
2557175|NCT02713659|Secondary|Health Services Utilization|Immunizations and well child visit data will be collected from electronic health records to measure impact of ELP intervention on health services use.|Birth to 6 months of age||||Participants|||Count of Participants
2561956|NCT02642952|Primary|Aix@75|Augmentation Index corrected to 75 bpm|Before surgery||||percentage||Standard Deviation|Mean
2557176|NCT02713659|Secondary|Change in StimQ Score|Reading activity is measured using the StimQ Read Subscale, a subscale scale of the overall StimQ that measures the home reading environment among young children ages 5 to 36 months, and is available in Spanish and English. The Read Subscale of the StimQ-I is used for infants 5-12 months old and contains 12 questions, while the Read Subscale of the StimQ-T is used for children aged 12-36 months old and contains 11 questions. Scores range from 0-19 with higher scores representing better home reading environments.|Change in StimQ score from 6 to 24 months of age|One participant only completed the StimQ survey at 24 months, therefore this number includes that participant. However, they are not counted in the total number of participants who completed the 24-month study visit because they did not complete the rest of the study visit surveys.|||Scores on a Scale||Standard Deviation|Mean
2557177|NCT02713659|Primary|Change in Preschool Language Scale-5th Edition Score|The Preschool Language Scale-5th Edition (PLS) is a validated measure of expressive and receptive language function among children from birth through 7 years of age and is available in Spanish and English. PLS-5 provides three norm-referenced standard scores: Auditory Comprehension (AC) standard score, Expressive Communication (EC) standard score, and Total Language (TL) composite score. The scores are on a normalized standard score scale that has a mean of 100 and a standard deviation of 15 with scores ranging from 0-200. Higher scores represent better language development..|Change in PLS scores from 6 to 24 months of age||||score on a scale||Standard Deviation|Mean
2557178|NCT02713594|Secondary|Cost-effectiveness|This analysis will quantify the costs of treatment for Control and Incentive conditions with regard to attaining 6-month abstinence. Project costs were allocated to three categories: 1) Service costs, including billed staff time for counseling and testing, as well as all incidentals connected with services; 2) Incentives and distribution costs; and 3) Service-related administrative costs, including promotion/marketing and staff time for administering the intervention. Costs of planning the project, grant administration, and research within the project are not included in the analysis.The outcome is the cost per quit in each treatment group. Cost per quit in each group was calculated by: 1) computing the grand total of costs for all participants in a given group; and 2) dividing the grand total for a given group by the number of successful quitters. As such, the cost per quit is a single value with no measure of dispersion.|Measured 6 months after enrollment||||U.S. Dollars|||Number
2557179|NCT02713594|Secondary|Engagement in Treatment|This analysis will compare number of calls completed|Measured 6 months after enrollment at follow-up assessment||||Participants|||Count of Participants
2557180|NCT02713594|Primary|Abstinence From Smoking|The primary outcome data will be the biochemically confirmed abstinence using urine (measured cotinine) or exhaled (breath) carbon monoxide (CO).|Measured 6 months after enrollment at follow-up assessment||||Participants|||Count of Participants
2557181|NCT02713542|Primary|Pain Scores Measured by Western Ontario and McMaster Universities Index (WOMAC) Survey|The WOMAC Pain score will be used to measure outcome, the score ranges from 0 to 20. The higher the score indicates greater pain.|6 month visit||||units on a scale||Full Range|Mean
2557182|NCT02713425|Secondary|Average Child Rating of Preferring the Game to Not Having the Game|rating of 0(without) to 10 (with) preference to use game|approximately 30 minutes|children with anxiety piloting game|||units on a scale||Standard Deviation|Mean
2557183|NCT02713425|Primary|Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session|Subjective Units of Distress Scale (SUDs) - of 0 to 10 ratings, where 0 indicates that they feel no anxiety whatsoever and 10 indicates that they are experiencing maximum distress. The child interacts with the game for up to 30 minutes. The interviewer observes and records the child's interaction with the game. The child then has an opportunity to perform a real life exposure. For the remainder of the time, the interviewer will interview the child about his/her experience with the game. They will also get feedback from the parent.|approximately 10 minutes||||score on a scale||Standard Deviation|Mean
2557184|NCT02713256|Primary|Percentage of Participants Whose Free Thyroxine (Free T4) Levels Decrease After 12 Week Treatment|Percentage of participants whose free thyroxine (free T4) levels decrease after 12 weeks of treatment (DAY85). A decrease is when free T4 level is below Upper limit of normal (ULN) ≤ 22.7 pmol/L)|12 week (DAY 85)|Pharmacodynamic (PD) Analysis Set- all patients in the study was included in this analysis set. Patients who discontinue before 4 weeks of treatment for any reason are not counted for the calculation of responders.|||percentage of participants|||Number
2557185|NCT02713256|Primary|Percentage of Participants Whose Total Triiodothyronine (Total T3) Levels Decrease After 12 Week Treatment|Percentage of participants whose total triiodothyronine (total T3) levels decrease after 12 week treatment. A decrease is when total T3 level is below Upper limit of normal (ULN) ≤ 2.79 nmol/L|12 week (DAY 85)|Pharmacodynamic (PD) Analysis Set- all patients in the study was included in this analysis set. Patients who discontinue before 4 weeks of treatment for any reason are not counted for the calculation of responders.|||percentage of participants|||Number
2557186|NCT02713256|Primary|Percentage of Participants Whose Thyroid Stimulating Hormone (TSH) Levels Normalize After 12 Week Treatment|Normalization of TSH is defined as TSH level greater than 0.35 mU/L after 12 week treatment (Day 85)|12 week (DAY 85)|Pharmacodynamic (PD) Analysis Set- all patients in the study was included in this analysis set. Patients who discontinue before 4 weeks of treatment for any reason are not counted for the calculation of responders.|||percentage of participants|||Number
2557187|NCT02713243|Primary|Stool Form at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined|Stool Form at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined Clinical Symptoms will be measured as change from baseline in stool types per Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify feces on a scale from 1 to 7 according to increasing wateriness.|Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined|PD analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data.|||score on a scale||Standard Deviation|Mean
2557190|NCT02713243|Secondary|(Cmax) of LJN452|Cmax is the observed maximum plasma (or serum or blood) concentration following drug administration [mass / volume]|Day 1 (Period 1 & 2) and Day 12 (Period 1 & 2)|PK analysis set: Patients with at least one valid PK concentration measurement and no major protocol deviations affecting PK - No statistical Analysis|||ng/mL||Standard Deviation|Mean
2561957|NCT02642835|Secondary|Number of Participants Who Experienced Intraoperative Complications|This records any problems that were encountered at the original insertion of the mesh. clinic visit|1 hour||||Participants|||Count of Participants
2557191|NCT02713243|Secondary|Area Under the Plasma Concentration-time Profile (AUCtau) of LJN452|AUCtau- is the area under the plasma (or serum or blood) concentration-time curve from time zero to the end of the dosing interval tau [mass x time / volume]|Day 1 (Period 1 & 2) and Day 12 (Period 1 & 2)|PK analysis set: Patients with at least one valid PK concentration measurement and no major protocol deviations affecting PK No statistical Analysis|||hr*ng/mL||Standard Deviation|Mean
2557192|NCT02713243|Primary|Stool Frequency at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 Combined|Stool frequency at Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined|Baseline, Week 1 (Period 1 & Period 2), Week 2 (Period 1 & Period 2), and Week 1 & 2 combined|PD analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data.|||Stools per week||Standard Deviation|Mean
2557193|NCT02713243|Primary|Number of Patients Reported With Adverse Events , Serious Adverse Events and Death.|Number of patients reported with adverse events , serious adverse events and death.|up to Day 79|Safety analysis set consists of 20 patients(10 pts per treatment period),17 &19 patients received at least 1 LJN & 1 Placebo dose, respectively, therefore 17 pts in the LJN452 &19 in the Placebo treatment periods were analyzed. Adverse events were summarized using descriptive statistics only with no formal statistical analysis performed.|||count of participants|||Number
2557194|NCT02713204|Other Pre-specified|Time to No Retinal and/or Subretinal Fluid Through Week 36|"Kaplan-Meier estimated time to no retinal and/or subretinal fluid through week 36 (days). Retinal and/or subretinal fluid was assessed using intraretinal fluid (IRF) cystoid edema and subretinal fluid (SRF). If answers were no to both measurements, there was no retinal and/or subretinal fluid (Dry); if yes to any of the 2 measurements, there was retinal and/or subretinal fluid (Not Dry); other than the previous 2 cases, retinal and/or subretinal fluid was undetermined."|Baseline through Week 36|"Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here Overall Number of Participants Analyzed = Participants who were evaluable for this outcome measure."|||Days||Standard Error|Mean
2557195|NCT02713204|Other Pre-specified|Proportion of Participants With No Retinal and/or Subretinal Fluid From Baseline Through Week 36|"Retinal and/or subretinal fluid was assessed using intraretinal fluid (IRF) cystoid edema and subretinal fluid (SRF) in the center subfield on OCT. If answers were no to both measurements, there was no retinal and/or subretinal fluid (Dry); if yes to any of the 2 measurements, there was retinal and/or subretinal fluid (Not Dry); other than the previous 2 cases, retinal and/or subretinal fluid was undetermined."|Baseline through Week 36|"Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here Overall Number of Participants Analyzed = Participants who were evaluable for this outcome measure."|||Proportion of participants|||Number
2557196|NCT02713204|Other Pre-specified|Proportion of Participants With No Retinal and/or Subretinal Fluid at Week 12|"Retinal and/or subretinal fluid was assessed using intraretinal fluid (IRF) cystoid edema and subretinal fluid (SRF) in the center subfield on optical coherence tomography (OCT). If answers were no to both measurements, there was no retinal and/or subretinal fluid (Dry); if yes to any of the 2 measurements, there was retinal and/or subretinal fluid (Not Dry); other than the previous 2 cases, retinal and/or subretinal fluid was undetermined."|At Week 12|"Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here Overall Number of Participants Analyzed = Participants who were evaluable for this outcome measure."|||Proportion of participants|||Number
2557197|NCT02713204|Secondary|Change From Baseline in Total Lesion Area at Week 36|Total lesion area was evaluated using fluorescein angiography (FA). Lesion area values measured in square millimeters (mm^2); lower values represent better outcomes.|At Week 36|"Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here Overall Number of Participants Analyzed = Participants who were evaluable for this outcome measure."|||mm^2||Standard Deviation|Mean
2557198|NCT02713204|Secondary|Change From Baseline in Total Lesion Area at Week 12|Total lesion area was evaluated using fluorescein angiography (FA). Lesion area values measured in square millimeters (mm^2); lower values represent better outcomes.|At Week 12|"Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here Overall Number of Participants Analyzed = Participants who were evaluable for this outcome measure."|||mm^2||Standard Deviation|Mean
2557199|NCT02713204|Secondary|Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 36|Choroidal neovascularization (CNV) was evaluated using fluorescein angiography (FA).CNV area values measured in square millimeters (mm^2); lower values represent better outcomes.|At Week 36|"Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here Overall Number of Participants Analyzed = Participants who were evaluable for this outcome measure."|||mm^2||Standard Deviation|Mean
2557200|NCT02713204|Secondary|Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 12|Choroidal neovascularization (CNV) was evaluated using fluorescein angiography (FA).CNV area values measured in square millimeters (mm^2); lower values represent better outcomes.|At Week 12|"Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here Overall Number of Participants Analyzed = Participants who were evaluable for this outcome measure."|||mm^2||Standard Deviation|Mean
2557267|NCT02711995|Secondary|Voice Handicap Index-10 (VHI-10)|The Voice Handicap Index-10 consists of 10 questions (statements about voice), where patients rate their the frequency of their problems as: never (0), almost never (1), sometimes (2), almost always (3), and always (4). The scores from each answer are added, and can range from 0-40. The higher the score, the worse the patient's perception of their voice handicap.|Baseline and 30 days after intervention||||units on a scale||Standard Deviation|Mean
2557201|NCT02713204|Secondary|Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 36|CST was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from LOCF post-baseline value at Week 36.|At Week 36|"FAS secondary randomization set was used. Here Overall Number of Participants Analyzed= Participants who were evaluable for this endpoint."|||Microns||Standard Deviation|Mean
2557202|NCT02713204|Secondary|Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 12|Central Sub-field Retinal Thickness (CST) was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from last observation carried forward (LOCF) post-baseline value at Week 12.|At Week 12|"Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here Overall Number of Participants Analyzed = Participants who were evaluable for this outcome measure."|||Microns||Standard Deviation|Mean
2557203|NCT02713204|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 36|Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. BCVA score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed post-baseline value at Week 36.|At Week 36||||Letters correctly read||Standard Deviation|Mean
2557204|NCT02713204|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 12|Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Best Corrected Visual Acuity (BCVA) score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed post-baseline value at Week 12.|At Week 12|"Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here Overall Number of Participants Analyzed = Participants who were evaluable for this outcome measure."|||Letters correctly read||Standard Deviation|Mean
2557205|NCT02712788|Secondary|mRS at 12 Months|Reported as number for each subject and then will look statistically to see if there is a difference between the active arm and the placebo arm. THe Modified Rankin Scale is Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death. Higher scores indicate worse outcome.|12 months|The 2 subjects in the milrinone arm were unable to be analyzed. 1 was withdrawn due to ineligibility and the other was withdrawn due to physician discretion.|||score on a scale||Full Range|Mean
2557206|NCT02712788|Primary|Modified Rankin Scale (mRS) at 6 Months|Reported as number for each subject and then will look statistically to see if there is a difference between the active arm and the placebo arm. The Modified Rankin scale is Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death. Higher scores indicate worse outcome.|6 months|The 2 subjects in the milrinone arm were unable to be analyzed. 1 subject was withdrawn due to ineligibilty and the other was withdrawn per physician discretion.|||score on a scale||Full Range|Mean
2557207|NCT02712554|Secondary|Pupillometry: TA_AUE of MPC in Treatment Phase|TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)|ITT population|||mm||Standard Deviation|Mean
2557208|NCT02712554|Secondary|Pupillometry: Maximum Pupil Constriction (MPC)|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. Pupil diameter was measured using electronic pupillometer. Measurements were collected under mesopic lighting conditions. For each subject, every effort was made to use the same eye for all assessments throughout the study. MPC is calculated as smallest observed pupil diameter - baseline pupil diameter.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)|ITT population|||mm||Standard Deviation|Mean
2557209|NCT02712554|Secondary|Change From Baseline in Number of Errors (Any Errors) in CRT Test in Treatment Phase|CRT is a computerized 5-choice reaction time test in which the subject must press and hold down a touchscreen button at the bottom of the screen. A yellow spot appeared inside one of 5 yellow circles at the top of the screen. Subjects were to respond to the spot as quickly as they could by letting go of the button and touching the circle where the yellow spot appeared. This was repeated for 30 trials. Lower scores indicate better performance. CRT also measures error scores and response accuracy. Any Errors is a combination of incorrect location errors, inaccurate response errors, no response errors, and premature errors.|0 (Baseline, pre-dose), 1, 2, 4, 8 and 24 hours (post-dose)|ITT population.|||Error per msec||Standard Deviation|Mean
2557210|NCT02712554|Secondary|Objective Measures: Change From Baseline in Choice Reaction Time (CRT) in Treatment Phase|CRT is a computerized 5-choice reaction time test in which the subject must press and hold down a touchscreen button at the bottom of the screen. A yellow spot appeared inside one of 5 yellow circles at the top of the screen. Subjects were to respond to the spot as quickly as they could by letting go of the button and touching the circle where the yellow spot appeared. This was repeated for 30 trials. Lower scores indicate better performance.|0 (Baseline, pre-dose), 1, 2, 4, 8 and 24 hours (post-dose)|ITT population.|||msec||Standard Deviation|Mean
2557211|NCT02712554|Secondary|Sedative and Other Effects: TA_AUE of Any Effects VAS in Treatment Phase|TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours|ITT population|||units on a scale||Standard Deviation|Mean
2557212|NCT02712554|Secondary|Sedative and Other Effects: Emax of Any Effects VAS in Treatment Phase|Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0.5 to 8 hours post-dose.|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours|ITT population|||units on a scale||Standard Deviation|Mean
2557213|NCT02712554|Secondary|Sedative and Other Effects: TA_AUE of Alertness/Drowsiness VAS in Treatment Phase|Alertness/Drowsiness VAS measures the sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of 'neither drowsy nor alert' (score of 50 mm), on the left with 'very drowsy' (score of 0 mm) and on the right with 'very alert' (score of 100 mm). Alertness/Drowsiness VAS was calculated by subtracting pre-dose (baseline) value from each post-dose value. TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using trapezoidal rule.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)|ITT population.|||units on a scale||Standard Deviation|Mean
2557214|NCT02712554|Secondary|Sedative and Other Effects: Emin of Alertness/Drowsiness VAS in Treatment Phase|Alertness/Drowsiness VAS measures the sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of 'neither drowsy nor alert' (score of 50 mm), on the left with 'very drowsy' (score of 0 mm) and on the right with 'very alert' (score of 100 mm). Alertness/Drowsiness VAS was calculated by subtracting pre-dose (baseline) value from each post-dose value. Emin is the smallest effect score between 0 to 8 hours post-dose.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)|ITT population.|||units on a scale||Standard Deviation|Mean
2557215|NCT02712554|Secondary|Negative Effects: TA_AUE of Bad Effects VAS in Treatment Phase|TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours|ITT population|||units on a scale||Standard Deviation|Mean
2557216|NCT02712554|Secondary|Negative Effects: Emax of Bad Effects VAS in Treatment Phase|Bad effects VAS measures the negative effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0.5 to 8 hrs.|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours|ITT population|||units on a scale||Standard Deviation|Mean
2557217|NCT02712554|Secondary|Positive Effects: TA_AUE of Good Effects VAS in Treatment Phase|TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours|ITT population|||units on a scale||Standard Deviation|Mean
2557218|NCT02712554|Secondary|Positive Effects: Emax of Good Effects VAS in Treatment Phase|Good drug effects VAS measures the positive effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0.5 to 8 hours post-dose.|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours|ITT population|||units on a scale||Standard Deviation|Mean
2557219|NCT02712554|Secondary|Positive Effects: TA_AUE of High VAS in Treatment Phase|TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)|ITT population|||units on a scale||Standard Deviation|Mean
2557220|NCT02712554|Secondary|Positive Effects: Emax of High VAS in Treatment Phase|High VAS measures the positive effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). For VAS assessment, pre-dose (baseline) value was subtracted from each post-dose value prior to calculation of the pharmacodynamic (PD) parameter. Emax is the largest effect score between 0 to 8 hours.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (post-dose)|ITT population|||units on a scale||Standard Deviation|Mean
2557221|NCT02712554|Secondary|Balance of Effects: Emax and Emin of Take Drug Again VAS in Treatment Phase|Take drug again VAS is the measure of balance of effects. It is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm bipolar VAS with score ranging from 0 mm to 100 mm (0 mm = 'definitely not', 50 mm = 'do not care', and 100 mm = 'definitely so'). Emax is the largest effect score and Emin is the smallest effect score between 0 to 8 hours post-dose.|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours|ITT population.|||units on a scale||Standard Deviation|Mean
2557222|NCT02712554|Secondary|Balance of Effects: Emax and Emin of Overall Drug Liking VAS in Treatment Phase|Overall drug liking VAS is the measure of balance of effects that assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100 mm bipolar VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = 'strong disliking', 50 mm = 'neither like nor dislike', and 100 mm = 'strong liking'). Emax is the largest effect score and Emin is the smallest effect score between 0 to 8 hours post-dose.|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours|ITT population.|||units on a scale||Standard Deviation|Mean
2557223|NCT02712554|Secondary|Balance of Effects: Time-averaged Area Under the Effect Curve (TA_AUE) of Drug Liking VAS in Treatment Phase|TA_AUE is AUE0-8hr divided by time from dosing to the actual time of the 8-hour post-dose assessment using the trapezoidal rule.|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours|ITT population|||units on a scale||Standard Deviation|Mean
2557224|NCT02712554|Secondary|Balance of Effects: Emin of Drug Liking VAS in Treatment Phase|Drug liking VAS is the measure of balance of effects that assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar (VAS) anchored in the center with a neutral anchor of 'neither like nor dislike' (score of 50 mm), on the left with 'strong disliking' (score of 0 mm) and on the right with 'strong liking' (score of 100 mm). Emin is the smallest effect score between 0.5 to 8 hours post-dose.|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours|ITT population.|||units on a scale||Standard Deviation|Mean
2557225|NCT02712554|Secondary|Number of Adverse Events in Dose Selection Phase|AE=Adverse Event. SAE=Serious adverse event. TEAE=Treatment-emergent adverse event.|Up to visit 3 (Follow up)|Safety population.|||Event|||Number
2557226|NCT02712554|Primary|Emax of Drug Liking VAS in Treatment Phase|Drug liking VAS is the measure of balance of effects that assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar (VAS) anchored in the center with a neutral anchor of 'neither like nor dislike' (score of 50 mm), on the left with 'strong disliking' (score of 0 mm) and on the right with 'strong liking' (score of 100 mm). Emax is the largest effect score between 0.5 to 24 hours post-dose.|0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 24 hours|Intended to treat (ITT) population.|||units on a scale||Standard Deviation|Mean
2557227|NCT02712554|Primary|Subjective Effects: Emax of Any Effects VAS in Dose Selection Phase|Any drug effects VAS measures other subjective effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). Emax is the largest effect score between 0 (pre-dose) to 24 hours post-dose.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours (post-dose)|"Safety population.~Parameters were not calculated for subjects who experienced emesis within the first 3 hours post-dose."|||units on a scale||Standard Deviation|Mean
2557228|NCT02712554|Primary|Subjective Effects: Maximum Effect (Emax) and Minimum Effect (Emin) of High Visual Analog Scale (VAS) in Dose Selection Phase|High VAS measures the positive effects experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (0 mm = 'definitely not') to 'extremely' (100 mm = 'definitely so'). For VAS assessment, pre-dose (baseline) value was subtracted from each post-dose value prior to calculation of the pharmacodynamic (PD) parameter. Emax is the largest effect score and Emin is the smallest effect score between 0 to 24 hours post-dose.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours (post-dose)|"Safety population.~Parameters were not calculated for subjects who experienced emesis within the first 3 hours post-dose."|||units on a scale||Standard Deviation|Mean
2557229|NCT02712359|Secondary|Number of Subjects With Anti-HAV Antibody Concentrations ≥ 15 mIU/mL at Approximately 10 Years Following Last Administered Havrix Dose - Exploration of Non-inferiority of the 1-dose Schedule Compared to the 2-dose Schedule of Havrix|Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.|At approximately 10 years after the last administered vaccine dose|The analysis was performed on the ATP cohort for persistence at Year 10, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 10 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records.|||Participants|||Count of Participants
2557230|NCT02712359|Secondary|Number of Subjects With Anti-HAV Antibody Concentration ≥ 15 mIU/mL at Approximately 8 Years Following Last Administered Havrix Dose - Exploration of Non-inferiority of the 1-dose Schedule Compared to the 2-dose Schedule of Havrix|Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.|At approximately 8 years after the last administered vaccine dose|The analysis was performed on the ATP cohort for persistence at Year 8, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 8 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records.|||Participants|||Count of Participants
2557231|NCT02712359|Secondary|Anti-HAV Antibody Concentrations at Approximately 10 Years Following Last Administered Havrix Dose|Anti-HAV antibody concentrations were measured by ELISA, expressed as GMCs, in mIU/mL. The cut-off of the assay was an anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL.|At approximately 10 years after the last administered vaccine dose|The analysis was performed on the ATP cohort for persistence at Year 10, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 10 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records.|||mIU/mL||95% Confidence Interval|Geometric Mean
2557232|NCT02712359|Secondary|Anti-HAV Antibody Concentrations at Approximately 8 Years Following Last Administered Havrix Dose|Anti-HAV antibody concentrations were measured by ELISA, expressed as GMCs, in mIU/mL. The cut-off of the assay was an anti-HAV antibody concentration equal to or above (≥) 15 mIU/mL.|At approximately 8 years after the last administered vaccine dose|The analysis was performed on the ATP cohort for persistence at Year 8, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 8 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records.|||mIU/mL||95% Confidence Interval|Geometric Mean
2557233|NCT02712359|Primary|Number of Subjects With Anti-HAV Seropositivity Status at Approximately 10 Years Following Last Administered Havrix Dose|Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 mIU/mL.|At approximately 10 years after the last administered vaccine dose|The analysis was performed on the ATP cohort for persistence at Year 10, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 10 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records.|||Participants|||Count of Participants
2557298|NCT02711345|Secondary|Percentage of Participants With Overall Response Rate (ORR)|Percentage of participants with overall response rate were reported.|Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)|The full analysis set included all participants who had received at least one dose of LTT462.|||Percentage of participants||95% Confidence Interval|Number
2561958|NCT02642835|Secondary|Number of Participants Who Needed Reoperations for Pain|patients may develop pain after the original operation which needs a second surgical procedure to try and help. clinic visit|1 hour||||Participants|||Count of Participants
2557234|NCT02712359|Primary|Number of Subjects With Anti-hepatitis A Virus (HAV) Seropositivity Status at Approximately 8 Years Following Last Administered Havrix Dose|Subjects are defined as being seropositive if their anti-HAV antibody concentration is equal to or above (≥) 15 milli-international unit/milliliter (mIU/mL).|At approximately 8 years after the last administered vaccine dose|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Year 8, which included all enrolled subjects who had a valid informed consent, had available assay results at Year 8 sero-surveys, had not received other HAV vaccine, with no history HAV infection prior to the study and who had available HAV vaccination records.|||Participants|||Count of Participants
2557235|NCT02712333|Secondary|Pulse Pressure|To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control).|at the end of each 9-day intervention||||mmHg||Standard Deviation|Mean
2557236|NCT02712333|Secondary|Diastolic Blood Pressure|To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control).|at the end of each 9-day intervention||||mmHg||Standard Deviation|Mean
2557237|NCT02712333|Secondary|Systolic Blood Pressure|To eliminate possible error, blood pressure for each participant were conducted by the same working staff using the same instrument. Average levels were calculated by treatments (intervention or control).|at the end of each 9-day intervention period||||mmHg||Standard Deviation|Mean
2557238|NCT02712333|Primary|Changes of Serum Norepinephrine Concentration|"Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.~Relative intensity was calculated by dividing the peak intensity of cortisol with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)"|at the end of each 9-day intervention||||relative intensity||Standard Deviation|Mean
2557239|NCT02712333|Primary|Changes of Serum Epinephrine Concentrations|"Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.~Relative intensity was calculated by dividing the peak intensity of epinephrine with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)"|at the end of each 9-day intervention||||relative intensity||Standard Error|Mean
2557240|NCT02712333|Primary|Changes of Serum Cortisone Concentration|"Use metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.~Relative intensity was calculated by dividing the peak intensity of cortisone with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)"|at the end of each 9-day intervention period||||relative intensity||Standard Error|Mean
2557241|NCT02712333|Primary|Changes of Serum Cortisol Levels|"Using metabolomic methods to screen and quantify all the serum metabolites, and calculate changes in main metabolites in sham purification compared to real purification.~Relative intensity was calculated by dividing the peak intensity of cortisol with the peak intensity of internal standard (2-chloro-D-phenylalanine methanol solution, 0.014mg/mL)"|at the end of each 9-day intervention period||||relative intensity||Standard Deviation|Mean
2557242|NCT02712320|Primary|Laboratory Assessments - Urinalysis|Urinalysis was performed to assess the safety profile of LMIS 50 mg during the study period, including pH, specific gravity, and the presences of leukocytes, erythrocytes, or protein.|48 weeks|8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination.|||Participants|||Count of Participants
2557243|NCT02712320|Primary|Laboratory Assessments - Biochemistry|Biochemical assessments performed in this study included Alanine Aminotransferase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP), total bilirubin, Blood Urea Nitrogen (BUN), serum Cr, potassium, sodium, magnesium, calcium, phosphorus, blood glucose, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and triglycerides.|48 weeks|8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination.|||Participants|||Count of Participants
2557244|NCT02712320|Primary|Laboratory Assessments - Hematology|Hematology assessments performed in this study included hemoglobin, hematocrit, Red Blood Cell (RBC), White Blood Cell (WBC), platelets, neutrophil, eosinophil, basophil, lymphocyte, monocyte, and HbA1c.|48 weeks|8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination.|||Participants|||Count of Participants
2557245|NCT02712320|Primary|Evaluate the Effect of LMIS 50 mg on Cardiovascular Function|Use 12-lead resting electrocardiograms (ECGs) to evaluate the effect of LMIS 50 mg on cardiovascular function, such as heart rate, RR interval, QRS complex, PR interval, and QT interval.|Up to 48 weeks|8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination.|||Participants|||Count of Participants
2557246|NCT02712320|Primary|Number of Participants With Adverse Events|Evaluate the incidence of adverse events, drug-related adverse events, and serious adverse events|Up to 48 weeks||||Participants|||Count of Participants
2557247|NCT02712099|Secondary|Abnormal Placental Lacunae by 3D Tomographic Ultrasound Imaging (TUI)|3D tomographic ultrasound imaging (TUI) of placenta previa with its lower edge covering the scar of previous cesarean section the examiner can simultaneously display, on the monitor or on a hard copy, up to 24 preselected parallel cuts from a volume. The slices can be generated either along the initial or any other reconstructed plane of the region of interest (ROI) in intervals of 0.5 - to 5 mm segments. Slice thickness will be adjusted as necessary for each individual case. The most informative image among the multiple images will be displayed with the use of CrossXBeam, a postprocessing tool that allows one to enhance tissue and border differentiation, leading to sharper depiction of the tissue margins|28 -36 weeks of gestation||||participants|||Number
2562100|NCT02641561|Secondary|The Number of Participants With Multiple Organ Failure (MOF) After ERCP as Assessed by Elevated International Normalized Ratio (INR)|INR > 1.5|30 days after ERCP||||Participants|||Count of Participants
2557248|NCT02712099|Secondary|Crowded Vessels Over Peripheral Sub-placental Zone by 3D Tomographic Ultrasound Imaging (TUI)|the examiner can simultaneously display, on the monitor or on a hard copy, up to 24 preselected parallel cuts from a volume. The slices can be generated either along the initial or any other reconstructed plane of the region of interest (ROI) in intervals of 0.5 - to 5 mm segments. Slice thickness will be adjusted as necessary for each individual case. The most informative image among the multiple images will be displayed with the use of CrossXBeam, a postprocessing tool that allows one to enhance tissue and border differentiation, leading to sharper depiction of the tissue margins|28 -36 weeks of gestation||||participants|||Number
2557249|NCT02712099|Secondary|Abnormal Placental Lacunae by Power Doppler Ultrasonography|Power Doppler ultrasonography criteria by Abnormal placental lacunae in placenta previa with its lower edge covering the scar of previous cesarean section|28 -36 weeks of gestation||||participants|||Number
2557250|NCT02712099|Secondary|Crowded Vessels Over Peripheral Sub-placental Zone by Power Doppler Ultrasonography|Power Doppler ultrasonography criteria of Crowded vessels over peripheral sub-placental zone of in placenta previa with its lower edge covering the scar of previous cesarean section|28 -36 weeks of gestation||||participants|||Number
2557251|NCT02712099|Primary|Abnormal Placental Lacunae by 2D Grayscale Ultrasonography|2D grayscale ultrasonography criteria of placenta accreta by Abnormal placental lacunae in placenta previa with its lower edge covering the scar of previous cesarean section|28 -36 weeks of gestation||||participants|||Number
2557252|NCT02712099|Primary|Loss of the Retro Placental Sonolucent Zone by 2D Grayscale Ultrasonography|2D grayscale ultrasonography criteria of placenta accreta by Loss of the retro placental sonolucent zone in placenta previa with its lower edge covering the scar of previous cesarean section|28 -36 weeks of gestation||||participants|||Number
2557253|NCT02712047|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Pre-treatment and for up to 7 Days After Cessation of Repeat Dose Treatment With FF/VI|FEV1 is defined as the maximal amount of air which can be exhaled forcefully in one second. Three technically acceptable FEV1 measurements were made using a spirometer, and were measured on pre-dose on Day 1, taken pre-dose on Day 14 and every morning and evening until Day 19, and in the morning on Day 21. Change from Baseline was measured by the value at post-dose visit minus the Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline is defined as the mean of Baseline across periods for each participant. Period level Baseline is defined as the difference between the Baseline and subject level Baseline for each period and each participant.|Baseline every morning and evening until Day 21 of each treatment period|PD Population|||Liter||Standard Deviation|Mean
2557254|NCT02712047|Secondary|Change From Baseline in Peak Expiratory Flow (PEF) During Treatment and Following Cessation of Repeat Dose Treatment With FF/VI|The PEF is a lung function evaluation assessed using a PEF meter. It was defined as the maximum amount of air exhaled during forced exhalation with lungs fully inflated. For PEF measurements the best of the 3 recordings were recorded AM and PM (i.e every 12 hours), from Day-7 through to Day 29 of TP1, and then from Day 1 of TP2 through to the (29). Change from Baseline was measured by the value at post-dose visit minus the Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline is defined as the mean of Baseline across periods for each participant. Period level Baseline is defined as the difference between the Baseline and subject level Baseline for each period and each participant. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.|Baseline and up to Day 29 in TP1; Baseline and up to follow up (Day 29) in TP2|PD population.|||Liter per minute||Standard Deviation|Mean
2557255|NCT02712047|Secondary|Change From Baseline in FeNO Over the FF/VI Treatment Period|In participants with asthma the FeNO is a non-invasive marker of airway inflammation. The FeNO was measured by the participants AM (pre-dose) and PM on Day -7 and all the way through Day 29 of each treatment period. The measurements were recorded using Niox Vero device provided at the site. These FeNO measurements were done throughout the treatment period. Change from Baseline was measured by the value at post-dose visit minus the Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline is defined as the mean of Baseline across periods for each participant. Period level Baseline is defined as the difference between the Baseline and subject level Baseline for each period and each participant. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates data was not available.|Baseline and up to Day 29 in each treatment period|PD Population.|||Parts per billion||Standard Deviation|Mean
2557256|NCT02712047|Primary|Change From Baseline in Fraction of Exhaled Nitric Oxide (FeNO) Over Time Following the Cessation of Repeat Dose Treatment With FF/VI|FeNO is non-invasive marker of airway inflammation in asthma participants. It was measured by the participants, using Niox Vero device at AM (pre-dose) and PM on Day -7 and all way through Day 29 of each TP. The FeNO measurements were done over time following stop of repeat dose treatment with FF/VI. Change from Baseline was measured as ratio of post-dose visit value to Baseline value. Baseline was defined as Day 1(Pre-dose). Subject level Baseline defined as the mean of Baseline across periods for each participant. Period level Baseline defined as the difference between the Baseline and subject level Baseline for each period and each participant. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Summary of ratio from Baseline for exhaled nitric oxide reported as Geometric mean and Geometric coefficient of Variation. NA indicates data was not available.|Baseline and up to Day 29 in each treatment period|The Pharmacodynamic (PD) Population consisted of all the participants from the All Subject population who had at least one PD assessment.|||Ratio of exhaled Nitric Oxide||Geometric Coefficient of Variation|Geometric Mean
2557257|NCT02712008|Secondary|Percentage of Participants With a ≥ 2-step Improvement at Week 36 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline|The Diabetic Retinopathy Disease Severity Scale (DRSS) was used to describe overall retinopathy severity. It measured the 5 levels of diabetic retinopathy ranging from absence of retinopathy to severe retinopathy (none, mild, moderate, severe, and proliferative).|Baseline, Week 36|FAS secondary randomization set was used. Overall Number of Participants Analyzed = Participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
2557299|NCT02711345|Primary|Dose Intensity Received by Participants|Dose intensity of LTT462 received by treatment group was reported.|Up to 2.8 years|The safety set included all participants who had received at least one dose of LTT462.|||milligram per day (mg/day)||Standard Deviation|Mean
2557258|NCT02712008|Secondary|Percentage of Participants With a ≥ 2-step Improvement at Week 12 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline|The Diabetic Retinopathy Disease Severity Scale (DRSS) was used to describe overall retinopathy severity. It measured the 5 levels of diabetic retinopathy ranging from absence of retinopathy to severe retinopathy (none, mild, moderate, severe, and proliferative).|Baseline, Week 12|"Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here Overall Number of Participants Analyzed = Participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
2557259|NCT02712008|Secondary|Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 36|CST was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from LOCF post-baseline value at Week 36.|Baseline, Week 36|"FAS secondary randomization set was used. Here Overall Number of Participants Analyzed= Participants who were evaluable for this endpoint."|||Microns||Standard Deviation|Mean
2557260|NCT02712008|Secondary|Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 12|Central Sub-field Retinal Thickness (CST) was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from LOCF post-baseline value at Week 12.|Baseline, Week 12|"Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here Overall Number of Participants Analyzed = Participants who were evaluable for this outcome measure."|||Microns||Standard Deviation|Mean
2557261|NCT02712008|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 36|Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. BCVA score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed post-baseline value at Week 36.|Baseline, Week 36|FAS secondary randomization set = all participants in full analysis set (FAS) who had completed study through week 12, received any study drug after secondary randomization or after Week 12, had BCVA assessment at Week 12 & had at least 1 post-Week 16 BCVA assessment. Overall Number of Participants Analyzed=Participants evaluable for this endpoint.|||Letters correctly read||Standard Deviation|Mean
2557262|NCT02712008|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 12|Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Best Corrected Visual Acuity (BCVA) score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed post-baseline value at Week 12.|Baseline, Week 12|"Full analysis set included all randomized participants who received any study drug, had baseline measurement of BCVA & at least 1 post-baseline assessment of BCVA. Last observation carried forward (LOCF) method was used to impute missing data. Here Overall Number of Participants Analyzed = Participants who were evaluable for this outcome measure."|||Letters correctly read||Standard Deviation|Mean
2557263|NCT02711995|Secondary|Aerodynamic Data- Maximum Phonation Time|Aerodynamic data were collected using the Phonatory Aerodynamic System (PAS) 6600 (Pentax). Subjects held a facemask coupled to a pneumotachometer with a pressure-sensor tube firmly over the nose and mouth, and rested the pressure-sensor tube in the oral cavity above the tongue. They produced sustained /a/ from which Maximum Sustained Phonation time was recorded.|Baseline and 30 days after intervention||||seconds (s)||Standard Deviation|Mean
2557264|NCT02711995|Secondary|Aerodynamic Data- Loudness|"Aerodynamic data were collected using the Phonatory Aerodynamic System (PAS) 6600 (Pentax). Subjects held a facemask coupled to a pneumotachometer with a pressure-sensor tube firmly over the nose and mouth, and rested the pressure-sensor tube in the oral cavity above the tongue. They produced sustained /a/ and We were away a year ago, from which loudness was analyzed via the Maximum Sustained Phonation and Running Speech protocols."|Baseline and 30 days after intervention||||Decibel of sound pressure level (dB SPL)||Standard Deviation|Mean
2557265|NCT02711995|Secondary|Aerodynamic Data- Peak Air Pressure|Aerodynamic data were collected using the Phonatory Aerodynamic System (PAS) 6600 (Pentax). Subjects held a facemask coupled to a pneumotachometer with a pressure-sensor tube firmly over the nose and mouth, and rested the pressure-sensor tube in the oral cavity above the tongue. A string of five consonant-vowel syllables (/pa/) at a comfortable pitch and loudness were analyzed through the Voicing Efficiency protocol to determine mean peak air pressure.|Baseline and 30 days after intervention||||Centimeter of water (cm H2O)||Standard Deviation|Mean
2557266|NCT02711995|Secondary|Percent of Normal Function (PNF)|The Percent of Normal Function (PNF) is a scale for patients to rate their recurrent functions in increments of five, from no function (0%) to normal function (100%). The higher the percentage, the more normal the function as experienced by the patient.|Baseline and 30 days after intervention||||percentage of normal function||Standard Deviation|Mean
2557300|NCT02711345|Primary|Percentage of Participants With at Least One Dose Interruptions|Percentage of participants with at least dose interruptions were reported.|Up to 2.8 years|The safety set included all participants who had received at least one dose of LTT462.|||Percentage of participants|||Number
2557268|NCT02711995|Secondary|Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)|"The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) is used to describe the severity of auditory-perceptual attributes of a voice problem. It indicates salient perceptual vocal attributes: (a) Overall Severity; (b) Roughness; (c) Breathiness; (d) Strain; (e) Pitch; and (f) Loudness. The CAPE-V displays each attribute accompanied by a 100- millimeter line forming a visual analog scale (VAS). The clinician indicates the degree of perceived deviance from normal for each parameter on this scale, using a tic mark. For each dimension, scalar extremes are unlabeled.~The scale range is from 0mm to 100mm. Results can indicate distance in mm to describe the degree of deviancy, so the higher the score the more deviancy from the norm there is."|Baseline and 30 days after intervention||||units on a scale||Standard Deviation|Mean
2557269|NCT02711995|Secondary|Aerodynamic Data- Airflow|"Aerodynamic data were collected using the Phonatory Aerodynamic System (PAS) 6600 (Pentax). Subjects held a facemask coupled to a pneumotachometer with a pressure-sensor tube firmly over the nose and mouth, and rested the pressure-sensor tube in the oral cavity above the tongue. They produced sustained /a/ and We were away a year ago, from which mean airflow wasanalyzed via the Maximum Sustained Phonation and Running Speech protocols."|Baseline and 30 days after intervention||||Liters per second (L/s)||Standard Deviation|Mean
2557270|NCT02711995|Secondary|Acoustic Analysis- Frequencies|"For acoustic assessment, subjects produced a sustained /a/ sound at their habitual speaking pitch and loudness and read assessment sentences from the Consensus Audio-Perceptual Evaluation of Voice (CAPE-V)protocol. Tasks were recorded and analyzed using the Analysis of Dysphonia in Speech and Voice (ADSV) and Multi-Dimensional Voice Profile (MDVP) software. A handheld microphone 3 inches from the subjects' mouths was used for all recordings.~The Sustained Vowel and All-Voiced Sentence protocols of the ADSV were used to obtain cepstral peak prominence fundamental frequency (CPP F0), The MDVP was used to obtain amplitude tremor frequency (Fatr), and fundamental frequency tremor frequency (Fftr)."|Baseline and 30 days after intervention||||Frequency (Hz)||Standard Deviation|Mean
2557271|NCT02711995|Primary|Vocal Tremor Scoring System (VTSS)|The Vocal Tremor Scoring System (VTSS) was developed to standardize the evaluation and scaling of vocal tremor. Tremor at a specific site was scored according to severity by the laryngologist. It can be rated as: none (0), mild/intermittent (1), moderate (2), severe (3). Six different regions were evaluated in this study: base of tongue, larynx, palate, pharyngeal walls, supraglottis, and true vocal folds. The scale range for each region was 0-3. The total score was a summation of all six regions, with a scalar range of 0-18.|Baseline and 30 days after intervention||||units on a scale||Standard Deviation|Mean
2557272|NCT02711839|Secondary|Triglyceride After Intervention|Triglyceride value after 60 days intervention in both groups|60 days||||mg/dL||Standard Deviation|Mean
2557273|NCT02711839|Secondary|Total Cholesterol After Intervention|Total cholesterol value after 60 days intervention in both groups|60 days||||mg/dL||Standard Deviation|Mean
2557274|NCT02711839|Secondary|Glucose After Intervention|Glucose value after 60 days intervention in both groups|60 days||||mg/dL||Standard Deviation|Mean
2557275|NCT02711839|Secondary|Albumin After Intervention|Albumin value after 60 days intervention in both groups|60 days||||g/dL||Standard Deviation|Mean
2557276|NCT02711839|Primary|HbA1c After Intervention|HbA1c value after 60 days intervention in both groups|60 days||||percentage||Standard Deviation|Mean
2557277|NCT02711800|Secondary|Change in Heart Rate|Beats per minute (Bpm)|Baseline and 30 days||||Beats per minute||Standard Deviation|Mean
2557278|NCT02711800|Secondary|Change in Salivary Cortisol (ug/dL)||Baseline and 30 days|Three participants excluded from analysis: 2 with no post-treatment data, 1 with neither pre- nor post-treatment data.|||ug/dl||Standard Deviation|Mean
2557279|NCT02711800|Secondary|Change in Trait-associated Co-functional Modules of Organisms||Baseline and 30 days||2019-04-30|04/2019||||
2557280|NCT02711800|Secondary|Change in Beta Diversity (PCoA)||Baseline and 30 days||2019-04-30|04/2019||||
2557281|NCT02711800|Secondary|Change in Alpha Diversity||Baseline and 30 days||2019-04-30|04/2019||||
2557282|NCT02711800|Secondary|Change in Relative Quantities of Taxa Among Groups Relative to Probiotic Administration||Baseline and 30 days||2019-04-30|04/2019||||
2557283|NCT02711800|Secondary|Percentage of Adherence to Treatment|"Adherence was calculated as: (the days probiotic was taken/total number of days of treatment) x 100, with results ranging from 0% (no probiotics taken at all) to 100% (probiotics taken 30 days out of the 30 day-treatment period). Researcher will subtract the number of pills/packets taken from the total amount."|30 days||||percentage of adherence||Full Range|Mean
2557284|NCT02711800|Primary|Change in Child Anxiety Symptoms|We report the change in magnitude of self-reported state anxiety derived from summed raw scores obtained through the six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory at baseline and 30 days from baseline. Scores in the scale range from 6-24, with greater scores indicating worse anxiety. We obtained the summed raw scores after reverse scoring items 1, 4 & 5.|Baseline and 30 days||||units on a scale||Standard Deviation|Mean
2557285|NCT02711800|Primary|Change in Child Abdominal Pain Frequency|Child and parent report is used to obtain ratings of pain frequency, the number of distinct occasions that pain was reported. Frequency was obtained for a one-week period pre and post intervention, and measured 3 times daily during these intervals. During the 30-day intervention, end of day frequencies were made. Pre-treatment assessments took place days 1-7, participants were treated days 8-36, and post-intervention assessments were completed days 37-44. The average number of episodes across these time points will be calculated pre and post treatment. The change in this average frequency from pre to post treatment will be the measure of change.|One week pre-intervention (Study Day 1), One week post-intervention (Study Day 44)|Data was missing for one participant|||pain episodes||Standard Deviation|Mean
2557301|NCT02711345|Primary|Percentage of Participants With at Least One Dose Reduction|Percentage of participants with at least one dose reduction were reported.|Up to 2.8 years|The safety set included all participants who had received at least one dose of LTT462.|||Percentage of participants|||Number
2557302|NCT02711345|Primary|Percentage of Participants With Dose Limiting Toxicities (DLTs)|Percentage of participants with dose limiting toxicity were reported.|Up to 2.8 years|The dose determining set included all participants from the safety set enrolled in the escalation part of the study who, during the first 28 days of dosing, had received at least 75 percent of the planned daily doses of LTT462 and had had sufficient safety evaluations, or had experienced a DLT.|||Percentage of participants|||Number
2557286|NCT02711800|Primary|Change in Child Abdominal Pain Rating|Child and parent report is used to obtain ratings of pain intensity on a 0-12 scale. A lower score equates to lower pain intensity. Ratings are obtained for a one-week period pre and post intervention, and measured 3 times daily. Pre-treatment assessments took place days 1-7, participants were treated days 8-36, and post-intervention assessments were completed days 37-44. All time points will be averaged and combined across raters (child and parent) resulting in an average pain severity rating pre and post-treatment. The change in this average rating will be assessed as pain severity outcome. This measure was averaged with the pain frequency average score (see Primary Outcome 2) to result in one primary severity/frequency pain rating pre and post treatment. The change in this combined measure is our primary index of change.|One week pre-intervention (Study Day 1), One week post-intervention (Study Day 44)|Data was missing for one participant|||units on a scale||Standard Deviation|Mean
2557287|NCT02711345|Secondary|Changes From Baseline in Relative Quantity (RQ) of Dual Specificity Phosphatase 6 (DUSP6) in Tumor Tissue and in Blood|Assessment of Pharmacodynamic (PD) effects of LTT462 in tumor, pre- and post- treatment tumor biopsies were examined for expression of DUSP6. For assessment of PD effects in blood, levels of DUSP6 were measured in blood samples.|Cycle 1 Days 1, 2, 3, 15 and 16|The full analysis set included all participants who had received at least one dose of LTT462.|||Ratio||Standard Deviation|Mean
2557288|NCT02711345|Secondary|Accumulation Ratio (Racc) of LTT462|Racc is the accumulation ratio calculated by AUCtau ratio Day 15 versus Day 1.|Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1|PAS included of all participants who have at least 1 PK blood sample providing measurable LTT462 and received at least 1 dose of study drug, didn’t vomit within 4 hours postdose, had at least 1 primary PK parameter. Here ‘N’ number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2557289|NCT02711345|Secondary|The Area Under the Curve Calculated to the End of a Dosing Interval (Tau) at Steady-state (AUCtau) of LTT462|AUCtau is the area under the curve calculated to the end of a dosing interval (tau) at steady-state calculated by formula amount *time * volume^-1|Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1|PAS included of all participants who have at least 1 PK blood sample providing measurable LTT462 and received at least 1 dose of study drug, didn’t vomit within 4 hours postdose, had at least 1 primary PK parameter. Here ‘N’ number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2557290|NCT02711345|Secondary|Elimination Half-life (T1/2) of LTT462|T1/2 is the Elimination half-life.|Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1|PAS included of all participants who have at least 1 PK blood sample providing measurable LTT462 and received at least 1 dose of study drug, didn’t vomit within 4 hours postdose, had at least 1 primary PK parameter. Here ‘N’ number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||hour||Full Range|Median
2557291|NCT02711345|Secondary|The Time to Reach Maximum (Peak) Plasma, Blood, Serum, or Other Body Fluid Drug Concentration (Tmax) After Single Dose Administration of LTT462|Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration.|day 1, day 15|PAS included of all participants who have at least 1 PK blood sample providing measurable LTT462 and received at least 1 dose of study drug, didn’t vomit within 4 hours postdose, had at least 1 primary PK parameter. Here ‘n’ number analyzed signifies number of participants who were evaluable at each time point.|||hour||Full Range|Median
2557292|NCT02711345|Secondary|Area Under the Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of LTT462|AUClast is the area under the curve from time zero to the last measurable concentration sampling time calculated by mass * time *volume^-1|Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1|PAS included of all participants who have at least 1 PK blood sample providing measurable LTT462 and received at least 1 dose of study drug, didn’t vomit within 4 hours postdose, had at least 1 primary PK parameter. Here ‘N’ number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2557293|NCT02711345|Secondary|The Maximum (Peak) Observed Plasma, Blood, Serum, or Other Body Fluid Drug Concentration (Cmax) After Single Dose Administration of LTT462|Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration expressed in mass x volume-1.|day 1, day 15|Pharmacokinetic (PK) analysis set (PAS) included of all participants who have at least 1 PK blood sample providing measurable LTT462 and received at least 1 dose of study drug, didn’t vomit within 4 hours postdose, had at least 1 primary PK parameter. Here ‘n’ number analyzed signifies number of participants who were evaluable at each time point.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2557294|NCT02711345|Secondary|Overall Survival (OS) - Only for Dose Expansion Phase|Median time for overall survival, only for dose expansion phase was reported.|Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)|Overall survival was not evaluated because the study ended before enrolling into the dose-expansion part.||||||
2557295|NCT02711345|Secondary|Progression Free Survival (PFS)|Median time for progression free survival was reported.|Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)|The full analysis set included all participants who had received at least one dose of LTT462.|||months||95% Confidence Interval|Median
2557296|NCT02711345|Secondary|Duration of Response (DOR)|DOR is defined as the time between the date of the first documented response (complete response [CR] or partial response [PR]) and the date of progression.|Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)|As there were no participant achieving response (CR or PR) during escalation phase of the study (only stable disease was achieved). Therefore the evaluation of duration of response could not be performed.||||||
2557297|NCT02711345|Secondary|Percentage of Participants With Disease Control Rate (DCR)|Percentage of participants with disease control rate were reported.|Every 2 cycles after starting LTT462 treatment until end of treatment (Up to 2.8 years)|The full analysis set included all participants who had received at least one dose of LTT462.|||Percentage of participants||95% Confidence Interval|Number
2557303|NCT02711345|Primary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse events is defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions that occur after participant's signed informed consent has been obtained. A SAE is described as any adverse event that leads to death, is life threatening, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above.|Up to 2.8 years|The safety set included all participants who had received at least one dose of LTT462.|||Percentage of participants|||Number
2557304|NCT02711306|Secondary|Lipid Index|LDL-C (low density lipoprotein cholesterol) analysis|4 weeks||||mg/dL||Standard Deviation|Mean
2557305|NCT02711306|Secondary|Glycemic Index|HbA1c (glycated hemoglobin) analysis|4 weeks||||percentage||Standard Deviation|Mean
2557306|NCT02711306|Secondary|Waist Circumference|Body waist by tape in centimeter|4 weeks||||cm||Standard Deviation|Mean
2557307|NCT02711306|Primary|Body Weight|Body weight by weighting scale (kilogram). Lower scores mean a better outcome in subjects.|4 weeks||||kg||Standard Deviation|Mean
2557308|NCT02710630|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)|This outcome measure presents area under the concentration-time curve of total Dabigatran in plasma over the time interval from 0 extrapolated to infinity)(if applicable).|1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.|"The PharmacoKinetic (PK) parameter analysis Set (PKS): Included all subjects of the treated set who provided at least one primary or secondary PK parameter.~PK Set 2 (PKS2): Included all subjects in the PKS who had evaluable PK variable of the reference treatment and at least one of the 5 test treatments.~PKS2 was used for statistical analyses."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2557309|NCT02710630|Secondary|Cmax (Maximum Plasma Concentration of Total Dabigatran)|This outcome measure presents maximum concentration of analyte in plasma (Cmax).|1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.|"The PharmacoKinetic (PK) parameter analysis Set (PKS): Included all subjects of the treated set who provided at least one primary or secondary PK parameter.~PK Set 2 (PKS2): Included all subjects in the PKS who had evaluable PK variable of the reference treatment and at least one of the 5 test treatments.~PKS2 was used for statistical analyses."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2557310|NCT02710630|Secondary|AUC0-tz (Area Under the Concentration-time Curve of Total Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|This outcome measure presents area under the concentration-time curve of total Dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point.|1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.|"The PharmacoKinetic (PK) parameter analysis Set (PKS): Included all subjects of the treated set who provided at least one primary or secondary PK parameter.~PK Set 2 (PKS2): Included all subjects in the PKS who had evaluable PK variable of the reference treatment and at least one of the 5 test treatments.~PKS2 was used for statistical analyses."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2557311|NCT02710630|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 Extrapolated to Infinity) (if Applicable)|This outcome measure presents area under the concentration-time curve of free Dabigatran in plasma over the time interval from 0 extrapolated to infinity)(if applicable).|1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.|"The PharmacoKinetic (PK) parameter analysis Set (PKS): Included all subjects of the treated set who provided at least one primary or secondary PK parameter.~PK Set 2 (PKS2): Included all subjects in the PKS who had evaluable PK variable of the reference treatment and at least one of the 5 test treatments.~PKS2 was used for statistical analyses."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2557312|NCT02710630|Primary|Cmax (Maximum Concentration of Free Dabigatran)|This outcome measure presents maximum concentration of analyte in plasma (Cmax).|1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.|The PharmacoKinetic (PK) parameter analysis Set (PKS): This analysis set included all subjects of the treated set who provided at least one primary or secondary PK parameter. Thus, a subject was included in the PKS, even if the subject contributed only one PK parameter value for one period to the statistical assessment.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2557313|NCT02710630|Primary|AUC0-tz (Area Under the Concentration-time Curve of Free Dabigatran in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|This outcome measure presents area under the concentration-time curve of free Dabigatran in plasma over the time interval from 0 to the time of the last quantifiable data point.|1:00 [hour (h): minute] before drug administration and 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h, 48:00h after drug administration.|The PharmacoKinetic (PK) parameter analysis Set (PKS): This analysis set included all subjects of the treated set who provided at least one primary or secondary PK parameter. Thus, a subject was included in the PKS, even if the subject contributed only one PK parameter value for one period to the statistical assessment.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2557314|NCT02710591|Other Pre-specified|PK Profile of Rimeporide - Cmax|"PK samples were collected according to the following schedule:~At Day 1: for half of the patients: just before first administration, and one sample in each of the following time frames after the first dose:~0.5 to 1h after dosing,~1 to 2h after dosing,~2.5 to 3.5h after dosing,~6h after dosing~At Day 1: for the other half of the patients: just before first administration, and one sample in each of the following time frames after the second dose:~0.5 to 1h after dosing,~1 to 2h after dosing,~2.5 to 3.5h after dosing,~6h after dosing~Finally, at week 4 (Day 28) after the last dose:~0.5 to 1h after dosing,~6h after dosing"|4 week study treatment||||ng/mL||Standard Deviation|Mean
2557339|NCT02710422|Secondary|Rates of Urinary Control Experienced by Study Participants|Rates of urinary control as measured by no pads per day at 3, 6, 9, and 12 months,|Baseline, 3, 6, 9, and 12 months Post-RARP|Due to early study termination, not all study participants completed scheduled visits.|||percentage of participants|||Number
2557315|NCT02710591|Primary|Number of Participants With Adverse Events|"Observations are given for the safety population (all patients who received at least one dose of study drug). Categorical data are presented with the number of subjects with at least one event for the following selections:~treatment-emergent AEs (TEAEs)~study drug-related TEAEs (ADRs)~serious TEAEs~study drug-related serious TEAEs (serious ADRs)~TEAEs leading to withdrawal~study drug-related TEAEs (ADRs) leading to withdrawal~serious TEAEs leading to withdrawal~TEAEs leading to death as outcome"|up to 6 weeks from first administration|Observations are given for the safety population (all patients who received at least one dose of study drug).|||Participants|||Count of Participants
2557316|NCT02710526|Other Pre-specified|Subject-rated Worst Daily Pain|Subject-rated worst daily pain, using an 11-point numerical rating scale (NRS) for pain, following repeated subcutaneous administration of CAM2038 weekly and CAM2038 monthly in adult opioid-dependent subjects-Safety Population. 11 point scale ranging from 0-10, with 0 being the least amount of pain to 10 being the worst pain imaginable.|99 days for Group 1, 162 days for Group 2, 127 days for Group 3|Safety Population: included all subjects who received CAM2038. Participants did not always enter pain scores in electronic diaries. Also, participants early terminated during the study and stopped entering scores.|||score on a scale||Standard Deviation|Mean
2557317|NCT02710526|Other Pre-specified|Number of Participants With Confirmed Opiate Independence as Confirmed by Negative Urine Toxicology Tests|Number of Participants with confirmed Opiate Independence as confirmed by Negative Urine Toxicology Tests-ITT Population|99 days for Group 1, 162 days for Group 2, 127 days for Group 3|ITT Population: included all subjects who received at least one dose of CAM2038 and provided some efficacy measures-Note that some patients dropped from the study so the numbers at the baseline may be different from later visits.|||Participants|||Count of Participants
2557318|NCT02710526|Other Pre-specified|Summary of Average Daily Pain by Week (ITT Population)|Summary of Average Daily Pain, using an 11-point Numerical Rating Scale (NRS) for pain, following repeated subcutaneous administration of CAM2038 weekly and CAM2038 monthly in adult opioid-dependent subjects. 11 point scale ranging from 0-10, with 0 being the least amount of pain to 10 being the worst pain imaginable. (ITT Population)|99 days for Group 1, 162 days for Group 2, 127 days for Group 3|ITT Population-consisted of all subjects who received at least 1 injection of CAM2038 and provided some efficacy measures. Participants did not always enter pain scores in electronic diaries. Also, participants early terminated during the study and stopped entering scores.|||score on a scale||Standard Deviation|Mean
2557319|NCT02710526|Secondary|Number of Participants With Adverse Events for Both Weekly and Monthly CAM2038|Number of Participants with Adverse Events for Both weekly and monthly CAM2038-Safety Population|99 days for Group 1, 162 days for Group 2, 127 days for Group 3|Safety Population: included all subjects who received CAM2038|||participants|||Number
2557320|NCT02710526|Primary|Time to Maximum Concentration at Steady State-Norbuprenorphine|Time to maximum concentration at steady state-Norbuprenorphine-Pharmacokinetic (PK) Population|PK samples at pre-dose, 0.5, 1, 2, 4, 6,10 hrs and approx. 24, 48, 72, 96, 120, 168, 240, 336, 504 and 672 hrs after CAM2038 q4w Dose 4 and pre-dose (within 45 mins), 10, 20, 30 and 40 mins, and 1, 1.5, 2, 3, 4, 6, 10, and 24 hrs after SL BPN dose 7|Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.|||h||Full Range|Median
2557321|NCT02710526|Primary|Maximum Steady State Concentration-Norbuprenorphine|Maximum steady state concentration-Norbuprenorphine-Pharmacokinetic (PK) Population|PK samples at pre-dose, 0.5, 1, 2, 4, 6,10 hrs and approx. 24, 48, 72, 96, 120, 168, 240, 336, 504 and 672 hrs after CAM2038 q4w Dose 4 and pre-dose (within 45 mins), 10, 20, 30 and 40 mins, and 1, 1.5, 2, 3, 4, 6, 10, and 24 hrs after SL BPN dose 7|Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2557322|NCT02710526|Primary|Average Steady State Concentration-Norbuprenorphine|Average steady state concentration-Norbuprenorphine-Pharmacokinetic (PK) Population|PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4|Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2557323|NCT02710526|Primary|Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Norepinephrine|Area Under the Curve at steady state (AUC during a 28-day dosing interval at steady state)-Norepinephrine-Pharmacokinetic (PK) Population|PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4|Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2557324|NCT02710526|Primary|Norbuprenorphine/Buprenorphine Ratios for Area Under the Curve at Steady State|Norbuprenorphine/buprenorphine ratios for Area Under the Curve at steady state Evaluable Pharmacokinetic (PKEVAL) Population|PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.|Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest|||ratio||Geometric Coefficient of Variation|Geometric Mean
2557325|NCT02710526|Primary|Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site|Tss,max (time to maximum concentration at steady state) for each injection site-Norbuprenorphine-Evaluable Pharmacokinetic (PKEVAL) Population|PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.|Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest|||h||Full Range|Median
2557326|NCT02710526|Primary|Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site.|Css,max (maximum observed plasma concentration during a dosing interval at steady state) for each injection site-Norbuprenorphine-Evaluable Pharmacokinetic (PKEVAL) Population|PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.|Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2557327|NCT02710526|Primary|Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site|Css,av (average plasma concentration during a dosing interval at steady state) for each injection site-Norbuprenorphine-Evaluable Pharmacokinetic (PKEVAL) Population|PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.|Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2557328|NCT02710526|Primary|AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm.|AUCss (area under the plasma concentration-time curve during a 7-day dosing interval at steady state) for each injection site, i.e., buttock (reference), abdomen, thigh and back of upper arm-Norbuprenorphine Evaluable Pharmacokinetic (PKEVAL) Population|PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.|Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2557329|NCT02710526|Primary|Norbuprenorphine/Buprenorphine Ratios at Maximum Concentration at Steady State|Norbuprenorphine/buprenorphine ratios at maximum concentration at steady state Evaluable Pharmacokinetic (PKEVAL) Population|PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.|Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest|||ratio||Geometric Coefficient of Variation|Geometric Mean
2557330|NCT02710526|Primary|Time to Maximum Concentration at Steady State-Buprenorphine|Time to maximum concentration at steady state-Buprenorphine Pharmacokinetic (PK) Population|PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4|Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.|||h||Full Range|Median
2557331|NCT02710526|Primary|Maximum Steady State Concentration-Buprenorphine|Maximum steady state concentration-BuprenorphinePharmacokinetic (PK) Population|PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4|Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2557332|NCT02710526|Primary|Average Steady State Concentration-Buprenorphine|Average steady state concentration-Buprenorphine-Pharmacokinetic Population|PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4|Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2557333|NCT02710526|Primary|Area Under the Curve at Steady State (AUC During a 28-day Dosing Interval at Steady State)-Buprenorphine|Area Under the Curve at steady state (AUC during a 28-day dosing interval at steady state)-Buprenorphine for Pharmacokinetic Population|PK samples were collected at pre-dose, 0.5, 1, 2, 4, 6, and 10 hours and at approximately 24, 48, 72,96, 120, 168 (7 days), 240 (10 days), 336 (14 days), 504 (21 days) and 672 (28 days) hours after CAM2038 q4w Dose 4|Pharmacokinetic (PK) Population consisted of all subjects in the Safety population who provided PK data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2557334|NCT02710526|Primary|Tss,Max (Time to Maximum Concentration at Steady State) for Each Injection Site|Tss,max (time to maximum concentration at steady state) for each injection site-buprenorphine|PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.|Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest|||h||Full Range|Median
2557335|NCT02710526|Primary|Css,Max (Maximum Observed Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site.|Css,max (maximum observed plasma concentration during a dosing interval at steady state) for each injection site-Buprenorphine|PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.|Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2557336|NCT02710526|Primary|Css,av(Average Plasma Concentration During a Dosing Interval at Steady State) for Each Injection Site for the Evaluable Pharmacokinetic (PKEVAL) Population|Css,av (average plasma concentration during a dosing interval at steady state) for each injection site-Buprenorphine for the Evaluable Pharmacokinetic (PKEVAL) Population|PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.|Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2557337|NCT02710526|Primary|AUCss(Area Under the Plasma Concentration-time Curve During a 7-day Dosing Interval at Steady State) for Each Injection Site, i.e., Buttock (Reference), Abdomen, Thigh and Back of Upper Arm for the Evaluable Pharmacokinetic (PKEVAL) Population|AUCss (area under the plasma concentration-time curve during a 7-day dosing interval at steady state) for each injection site, i.e., buttock (reference), abdomen, thigh and back of upper arm-Buprenorphine for the Evaluable Pharmacokinetic (PKEVAL) Population|PK samples were collected at pre-dose and at 0.5, 1, 2, 4, 6, 10, 24, 30, 48, 72, 96, 120 and 168 hours post-CAM2038 q1w for Doses/Weeks 4, 5, 6, and 7.|Evaluable Pharmacokinetic (PKEVAL) Population consisted of all subjects who had sufficient PK data for all 4 randomized injection sites to derive PK parameters of interest.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2557338|NCT02710422|Secondary|5-year Rate of Prostate Cancer Recurrence Between Both Study Arms|Rate of prostate cancer recurrence in study participants in both study arms at 5 years post-radical prostatectomy.|5 years post-RARP|Data were not collected due to early termination of study.||||||
2557340|NCT02710422|Secondary|Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP|Among men with a SHIM greater than or equal to 17 at baseline, the investigators will evaluate the proportion of men who require the use of more invasive erectile aids (intra-cavernosal injection, vacuum pump, or penile prosthesis) at 3, 6, 9, and 12 months post RARP.|3, 6, 9 and 12 Months Post-RARP|Participants with a SHIM score of greater than or equal to 17 at baseline. Due to early study termination, not all study participants completed scheduled visits.|||percentage of participants|||Number
2557341|NCT02710422|Secondary|Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP.|Among men with a SHIM greater than or equal to 17 at baseline, the investigators will compare the proportion of men in each group who are able to achieve an erection sufficient for intercourse more than 50% of the time at 3, 6, 9 and 12 months post RARP.|Baseline, 3, 6, 9 and 12 months Post-RARP|Participants with a SHIM score of greater than or equal to 17 at baseline. Due to early study termination, not all study participants completed scheduled visits.|||percentage of participants|||Number
2557342|NCT02710422|Secondary|Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP|Among men with a SHIM greater than or equal to 17 at baseline, the investigators will compare the proportion of men in each group with mild ED or better, defined by a SHIM greater than or equal to 17, at 3, 6, 9 and 12 months post RARP.|Baseline, 3, 6, 9 12 Months Post-RARP|Participants with a SHIM score of greater than or equal to 17 at baseline. Due to early study termination, not all study participants completed scheduled visits.|||percentage of participants|||Number
2557343|NCT02710422|Primary|The Difference in Average Change in SHIM Score, Between Baseline and 12-Months Post-RARP, of Study Participants in Each Group|The difference in average change in Sexual History Inventory for Men (SHIM) score, between baseline and 12 months post RARP between the membrane and control arms will be assessed as the primary endpoint. The SHIM score is measured in points on a scale: The minimum score is 5 to 7 indicating severe erectile dysfunction (ED), the maximum score is 22 to 25, indicating no ED.|Baseline, 12 Months Post-RARP|Due to early study termination, not all study participants completed scheduled visits.|||scores on a scale||Standard Deviation|Mean
2557344|NCT02710292|Primary|"Percentage of Subjects With Investigator-rated Lens Centration of Optimal After 10 Days of Wear"|Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.|Day 10, each product|This analysis population includes all subjects who used the study device and in whom data after the use of the study device were available (Full Analysis Set).|||percentage of subjects|||Number
2557345|NCT02710136|Secondary|Change in Log Base 10 Albumin in Nasal Secretions|Albumin is a protein in the human body. Levels are hypothesized to be related to the extent of allergic response. Change is computed by subtracting the albumin level prior to the Nasal Allergen Challenge (NAC) from the albumin level after the last dose received during the NAC. A log base 10 transformation is applied to both baseline and post-baseline measures. A positive change score indicates that albumin levels increased over the course of the NAC.|NAC Baseline through last dose of German cockroach allergen administered during the NAC|Phase 1a and Phase 2 Participants who started a NAC and had an evaluable baseline and post-baseline albumin measurement.|||mcg/L||Standard Deviation|Mean
2557346|NCT02710136|Secondary|Change in Log Base 10 Tryptase in Nasal Secretions|Tryptase is a protein in the human body. Levels are hypothesized to be related to the extent of allergic response. Change is computed by subtracting the tryptase level prior to the Nasal Allergen Challenge (NAC) from the tryptase level after the last dose received during the NAC. A log base 10 transformation is applied to both baseline and post-baseline measures. A positive change score indicates that tryptase levels increased over the course of the NAC.|NAC Baseline through last dose of German cockroach allergen administered during the NAC|Phase 1a and Phase 2 Participants who started a NAC and had an evaluable baseline and post-baseline tryptase measurement.|||mcg/L||Standard Deviation|Mean
2557347|NCT02710136|Secondary|Change in Visual Analogue Score|"Participants self-reported their score, reflecting the severity of their nasal symptoms-sneezing, runny nose, stuffy nose, itchy nose- on a Visual Analogue Scale (0 to 10 centimeters). The left-hand side of the scale (0) represents No Symptoms, and the right hand side of the scale (10) represents As Bad as I Can Imagine.~Change is computed by subtracting the VAS score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge (NAC) from the VAS score obtained at the last tolerated dose of German cockroach allergen received during the NAC. A positive change score indicates that nasal symptoms increased over the course of the NAC."|NAC Baseline through last dose of German cockroach allergen administered during the NAC|Phase 1a and Phase 2 Participants who started a NAC|||Centimeters||Standard Deviation|Mean
2557348|NCT02710136|Secondary|Change in Peak Expiratory Flow (PEF) L/Min|PEF is defined as the speed of expiration of air in Liters per minute when breathing out of the lungs. Change is computed by subtracting the PEF score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge (NAC) from the PEF score obtained at the last tolerated dose of German cockroach allergen received during the NAC. A positive change score indicates that speed of expiration increased over the course of the Challenge, while a negative change score indicates speed of expiration decreased over the course of the NAC.|NAC Baseline through last dose of German cockroach allergen administered during the NAC|Phase 1a and Phase 2 Participants who started a NAC|||L/min||Standard Deviation|Mean
2557349|NCT02710136|Secondary|Change in Peak Nasal Inspiratory Flow (PNIF) L/Min|PNIF is defined as the speed of inspiration of air in Liters per minute when breathing into the lungs. Change is computed by subtracting the PNIF score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge (NAC) from the PNIF score obtained at the last tolerated dose of German cockroach allergen received during the NAC. A negative change score indicates that speed of inspiration decreased over the course of the NAC.|NAC Baseline through last dose of German cockroach allergen administered during the NAC|Phase 1a and Phase 2 Participants who started a NAC|||L/min||Standard Deviation|Mean
2557393|NCT02709486|Secondary|Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis|Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Domain evaluated was number of nights stayed in the hospital due to OA.|Baseline, Weeks 32 and 48|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||nights||Full Range|Median
2557350|NCT02710136|Secondary|Change in Total Nasal Symptom Score (TNSS)|TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring sneezing, runny nose, stuffy nose, and itchy nose symptoms. Participants indicate a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. Change is computed by subtracting the TNSS score obtained after the nasal rinse administered prior to the Nasal Allergen Challenge from the TNSS score obtained at the last tolerated dose of German cockroach allergen received during the Nasal Allergen Challenge (NAC). A positive change score indicates that nasal symptoms increased over the course of the NAC.|NAC Baseline through last dose of German cockroach allergen administered during the NAC|Phase 1a and Phase 2 Participants who started a NAC|||Scores on a Scale||Standard Deviation|Mean
2557351|NCT02710136|Secondary|Highest Total Nasal Symptom Score (TNSS)|TNSS (0-12) is a participant rated score computed as the sum of four subscale scores (0-3) measuring sneezing, runny nose, stuffy nose, and itchy nose symptoms. Participants provide a score on each subscale of 0, 1, 2, or 3, indicating none, mild, moderate, or severe symptoms, respectively. The highest TNSS observed after administration of any of the German cockroach allergen doses received during the Nasal Allergen Challenge (NAC) is summarized.|NAC Baseline through last dose of German cockroach allergen administered during the NAC|Phase 1a and Phase 2 Participants who started a NAC|||Scores on a Scale||Standard Deviation|Mean
2557352|NCT02710136|Secondary|Number of Sneezes at Each of Nine Doses of German Cockroach Allergen|Nine increasing doses of German cockroach allergen (0, 0.00381, 0.01204, 0.0380, 0.120, 0.379, 1.20, 3.78, and 11.9 mcg/mL) were administered during the Nasal Allergen Challenge (NAC). After administration of each dose, the number of times the participant sneezed was recorded. Participants continued receiving doses of German cockroach allergen until threshold criteria described in the primary endpoint were met. Number of sneezes was carried forward for doses not received beyond the dose at which the threshold criteria were initially met. Number of sneezes is summarized at each dose.|NAC Baseline through last dose of German cockroach allergen administered during the NAC|Phase 1a and Phase 2 Participants who started a NAC|||Count of sneezes||Standard Deviation|Mean
2557353|NCT02710136|Primary|Cumulative Proportion of Participants Meeting Either a Total Nasal Symptom Score (TNSS) Threshold or Sneezing Score Threshold During the Cockroach Allergen (CA) Nasal Allergen Challenge (NAC)|"Result is the proportion of participants (Pss) responding at each of 9 CA doses during the NAC.To illustrate the variability of the outcome at each dose,the protocol specifies computation of 95% CIs for the proportion responding at each dose.A proportion is to record for each Ps a 0 for non-responder and 1 for responder &compute the mean of the 0 &1 values.Summary statistic for this method: a mean.~After each dose,TNSS &TNSS Sneezing scores were recorded.TNSS (0-12) is a self-rated score computed as the sum of 4 subscale scores (0-3) measuring sneezing, runny nose, stuffy nose, & itchy nose symptoms (sxs).Pss provide a score on each subscale of 0, 1, 2, or 3(none, mild, moderate, or severe sxs, respectively).Pss cont'd receiving doses until either a TNSS (≥8 in adults,≥6 in children) or sneezing score threshold [TLV] of 3 was met.Assumption: Pss met TLV criteria for doses not recv'd beyond dose at which TLV criteria were initially met."|NAC Baseline through last dose of German cockroach allergen administered during the NAC|Phase 1a and Phase 2 Participants who started a NAC|||Cumulative proportion of participants||95% Confidence Interval|Mean
2557354|NCT02710045|Secondary|Measles Antibody Levels at 19 Months of Age|Measles antibody levels were measured by haemagglutination inhibition assay (HAI) at 19 months of age, 4 weeks after MV challenge at 18 months of age. The aim was to determine whether the vaccination schedule at 9 months of age altered responses to a subsequent MV challenge at 18 months of age i.e., the antibody measurement was made 10 months after the first study intervention.|10 months (19 months of age)|Study children at 19 months of age. Not all participants had this assay done due to the follow reasons: failure to attend the appointment, unwell on the day of follow up, dropped out of the study, assay failure, insufficient blood sample volume or quality.|||HAI titre||Standard Deviation|Mean
2557355|NCT02710045|Secondary|Effect of Vaccine Group on Pertussis Toxoid Antibody Levels|Plasma pertussis toxoid antibodies were measured by multiplex microsphere-based fluorescent immunoassay at 9 and 10 months of age|4 weeks (9 and 10 months of age)|Study infants at 9 and 10 months of age. Not all participants had this assay done due to the follow reasons: failure to attend the appointment, unwell on the day of follow up, dropped out of the study, assay failure, insufficient blood sample volume or quality.|||EU/mL||Standard Deviation|Mean
2557356|NCT02710045|Secondary|Effect of Vaccine Group on Diphtheria and Tetanus Antibody Levels|Plasma diphtheria and tetanus toxoid antibodies were measured by multiplex microsphere-based fluorescent immunoassay at 9 and 10 months of age.|4 weeks (9 and 10 months of age)|Study infants at 9 and 10 months of age. Not all participants had this assay done due to the follow reasons: failure to attend the appointment, unwell on the day of follow up, dropped out of the study, assay failure, insufficient blood sample volume or quality.|||IU/mL||Standard Deviation|Mean
2557357|NCT02710045|Secondary|Effect of Vaccine Group on Effector Memory T Cells (TEM)|CD4+CD45RO+CD62L- effector memory T cells measured by flow cytometry at 9 and 10 months of age|4 weeks (9 and 10 months of age)|Study infants at 9 and 10 months of age. Not all participants had this assay done due to the follow reasons: failure to attend the appointment, unwell on the day of follow up, dropped out of the study, assay failure, insufficient blood sample volume or quality.|||Percent of all CD4+ T cells||Standard Deviation|Mean
2557358|NCT02710045|Secondary|Effect of Vaccine Group on Measles Antibody Levels|Effect of combining MV and DTP on measles antibody responses to see if combining vaccines interferes with antibody generation. Plasma measles antibodies measured by haemagglutination inhibition assay at 9 and 10 months of age.|4 weeks (9 and 10 months of age)|Study infants at 9 and 10 months of age. Not all participants had this assay done due to the follow reasons: failure to attend the appointment, unwell on the day of follow up, dropped out of the study, assay failure, insufficient blood sample volume or quality.|||Haemagglutination titre||Standard Deviation|Mean
2557359|NCT02710045|Primary|Effect on CD4+FOXP3+CD127- Regulatory T Cell Frequencies|Regulatory T cell (Treg) frequencies (among all gated CD4+ T cells) at 9 and 10 months of age determined by flow cytometry and compared between the 3 intervention groups with the primary hypothesis that the MV+DTP group will have lower Treg frequencies than the MV group.|4 weeks (9 months and 10 months of age)|Study infants at 9 and 10 months of age. Not all participants had this assay done due to the follow reasons: failure to attend the appointment, unwell on the day of follow up, dropped out of the study, assay failure, insufficient blood sample volume or quality.|||Percentage of CD4+ T cells||Standard Deviation|Mean
2557360|NCT02710045|Primary|Effect on Interferon (IFN)-Gamma : Interleukin (IL)-4 Ratio in Plasma|The IFN-gamma:IL-4 cytokine ratio in plasma samples taken 4 weeks after vaccination measured by multiplex assay using the Bio-Plex 200 Suspension Array system. Ratio compared between the 3 intervention groups with the hypothesis that the MV+DTP group will have a higher ratio than the other 2 groups.|4 weeks after vaccination|Not all participants had this assay done due to the follow reasons: failure to attend the appointment, unwell on the day of follow up, dropped out of the study, assay failure, insufficient blood sample volume or quality.|||ratio of cytokines in pg/mL||Standard Deviation|Mean
2557361|NCT02709785|Secondary|Bleeding Score|Bleeding Score is determined by adding the number of bleeding sites and dividing by the number of teeth to assess gingival inflammation. The higher the score, the worse the inflammation. Differences were assessed between treatment groups for changes in values from baseline to 6 weeks. If data were normally distributed, the paired t test was used to assess changes; otherwise the Wilcoxon signed rank test was used.|6 weeks||||units on a scale||Inter-Quartile Range|Median
2557362|NCT02709785|Secondary|Plaque Index|Plaque Index scores plaque accumulation from 0 (no plaque) to 5 (plaque covering 2/3 of surface or more). The higher the score, the more plaque accumulation (worse outcome). Differences were assessed between treatment groups for changes in values from baseline to 6 weeks. If data were normally distributed, the paired t test was used to assess changes; otherwise the Wilcoxon signed rank test was used.|6 weeks||||units on a scale||Inter-Quartile Range|Median
2557363|NCT02709785|Secondary|Tooth Stain Index|"Tooth Stain Index scores the amount of tooth stain from 0 (no stain) to 3 (greater than 2/3 of surface). The higher the score, the worse the staining. Differences were assessed between treatment groups for changes in values from baseline to 6 weeks. If data were normally distributed, the paired t test was used to assess changes; otherwise the Wilcoxon signed rank test was used. The score (0-3) for each tooth are summed for the total score. The 8 incisor teeth are scored. The minimum score for a subject is 0 and the maximum score for a subject is 24 (worse outcome)."|6 weeks||||units on a scale||Inter-Quartile Range|Median
2557364|NCT02709785|Secondary|Calculus Index|Calculus Index scores the amount of calculus accumulation by adding surfaces from the lingual of the mandibular anterior teeth. The higher the score, the worse the calculus accumulation. Differences were assessed between treatment groups for changes in values from baseline to 6 weeks. If data were normally distributed, the paired t test was used to assess changes; otherwise the Wilcoxon signed rank test was used.|6 weeks||||units on a scale||Inter-Quartile Range|Median
2557365|NCT02709785|Primary|Gingival Index|Gingival Index scores gingival inflammation from 0 (healthy) to 3 (severe inflammation). The higher the score, the greater the gingival inflammation (worse outcome). Differences were assessed between treatment groups for changes in values from baseline to 6 weeks. If data were normally distributed, the paired t test was used to assess changes; otherwise the Wilcoxon signed rank test was used.|6 weeks||||units on a scale||Inter-Quartile Range|Median
2557366|NCT02709577|Secondary|Absolute Weight Change||24 weeks or 52 weeks||||kg||Standard Deviation|Mean
2557367|NCT02709577|Primary|Change in HbA1c Values From Baseline Measurement|"Cohort A: Assessment of improvement in the glycemic control defined as a change in HbA1c values from baseline.~Cohort B. Assessment of improvement in glycemic control defined as a change in HbA1c values of at least 0.5% from baseline."|Baseline to 24 weeks or 52 weeks||||percentage of HbA1c||Standard Deviation|Mean
2557368|NCT02709538|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs).|All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported.|52 weeks|Safety Analysis Set (SAS) will consist of all subjects who took at least 1 dose of study medication following randomization. This was the primary analysis set for safety analyses.|||participants|||Number
2557369|NCT02709486|Secondary|Number of Participants With Anti Tanezumab Antibodies|Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA). Participants listed as having anti-tanezumab antibodies had ADA titer level >=3.32. Less than 3.32 was considered below the limit of quantitation.|Baseline, Weeks 8,16, 24, 32 and 48|The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||Participants|||Count of Participants
2557370|NCT02709486|Secondary|Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48|NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis), higher score indicated higher abnormality/impairment and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent), higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment.|Baseline, Weeks 2, 4, 8, 12, 16, 24, 32 and 48|The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||units on a scale||Standard Deviation|Mean
2557371|NCT02709486|Secondary|Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Week 24|The SAS is a 12 item (11 for females) questionnaire, from which the total number of symptoms (0-12 for males and 0-11 for females) is calculated. Each positive symptom is rated from 1 (not at all) to 5 (a lot). The total impact score was the sum of all symptom rating scores, with 0 assigned where the participant did not have the particular symptom. The range for the total impact score is 0-60 for males and 0-55 for females, higher scores indicating higher impact.|Baseline, Week 24|The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||units on a scale||Standard Deviation|Mean
2557394|NCT02709486|Secondary|Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis|Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Domain evaluated was number of participants who were hospitalized due to OA.|Baseline, Weeks 32 and 48|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||Participants|||Count of Participants
2557372|NCT02709486|Secondary|Number of Participants With Confirmed Orthostatic Hypotension|Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: For systolic BP <=150 mmHg (mean supine): Reduction in systolic BP>=20 mmHg or reduction in diastolic BP>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP >150 mmHg (mean supine): Reduction in systolic BP>=30 mmHg or reduction in diastolic BP>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed.|Baseline, Weeks 2, 4, 8, 12, 16, 24, 32 and 48|The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here, ‘Overall number of participants analyzed’ signifies participants analyzed for this outcome measure.|||Participants|||Count of Participants
2557373|NCT02709486|Secondary|Percentage of Participants With Total Joint Replacements|Percentage of participants who underwent at least one total knee, hip or shoulder joint replacement surgery.|Baseline up to Week 48|The safety population was defined as all participants treated with tanezumab or placebo subcutaneously.|||percentage of participants||95% Confidence Interval|Number
2557374|NCT02709486|Secondary|Percentage of Participants With Adjudicated Joint Safety Outcomes|Incidence of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive OA (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture.|Baseline up to Week 48|The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here, ‘Overall number of participants analyzed’ signifies participants analyzed by adjudication committee.|||percentage of participants||95% Confidence Interval|Number
2557375|NCT02709486|Secondary|Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 24 and 48|Heart rate was measured at sitting position.|Baseline, Weeks 24 and 48|The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||beats per minute||Standard Deviation|Mean
2557376|NCT02709486|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48|A 12-lead ECG was recorded after participants had rested for at least 5 minutes in the supine position in a quiet environment. All standard intervals (PR, QRS, QT, QTcF, QTcB, QTcF, RR intervals) were collected.|Baseline, Weeks 24 and 48|The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||millisecond||Standard Deviation|Mean
2557377|NCT02709486|Secondary|Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48|Heart rate was measured at sitting position.|Baseline, Weeks 2, 4, 8, 12,16, 24, 32 and 48|The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified time points.|||beats per minute||Standard Deviation|Mean
2557378|NCT02709486|Secondary|Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48|Measurement of BP included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP).|Baseline, Weeks 2, 4, 8, 12, 16, 24, 32 and 48|The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2557379|NCT02709486|Secondary|Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline|Primary Abnormality criteria: hemoglobin; hematocrit; RBC count < 0.8*LLN; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*ULN; platelets <0.5*LLN,>1.75*upper limit of normal (ULN); white blood cell count<0.6*LLN, >1.5*ULN; Lymphocytes, Leukocytes, Neutrophils <0.8*LLN, >1.2*ULN; Basophils, Eosinophils, Monocytes >1.2*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides >1.3*ULN; Urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN; Hemoglobin A1C >1.3*ULN; creatine kinase >2.0*ULN; Nitrite >=1.|Baseline up to Week 48|The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here “Overall number of participants analysed” signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2557380|NCT02709486|Secondary|Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline|Primary Abnormality criteria: HGB, hematocrit, RBC count <0.8* lower limit of normal(LLN); Ery. mean corpuscular volume/hemoglobin/ HGB concentration, RBCs distribution width <0.9*LLN, >1.1*upper limit of normal(ULN); platelets <0.5*LLN,>1.75*ULN; WBC count<0.6*LLN, >1.5*ULN; Lymphocytes,Leukocytes,Neutrophils <0.8*LLN, >1.2*ULN; Basophils,Eosinophils,Monocytes>1.2*ULN; Prothrombin time/Intl. normalized ratio>1.1*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase,alanine aminotransferase,gamma GT,LDH,alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen,creatinine,Cholesterol,triglycerides >1.3*ULN; Urate>1.2*ULN; sodium<0.95*LLN,>1.05*ULN; potassium,chloride,calcium,magnesium,bicarbonate <0.9*LLN, >1.1*ULN; phosphate<0.8*LLN, >1.2*ULN; glucose<0.6*LLN, >1.5*ULN; HGB A1C >1.3*ULN; creatine kinase>2.0*ULN, specific gravity<1.003, >1.030; pH<4.5, >8; Urine Glucose, protein,HGB,bilirubin >=1; Ketones>=1;Urine erythrocytes,Leukocytes>=20.|Baseline up to Week 48|The safety population was defined as all participants treated with tanezumab or placebo subcutaneously. Here 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2557381|NCT02709486|Secondary|Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to week 48 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.|Baseline up to Week 48|The safety population was defined as all participants treated with tanezumab or placebo subcutaneously.|||Participants|||Count of Participants
2557382|NCT02709486|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to week 48 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.|Baseline up to Week 48|The safety population was defined as all participants treated with tanezumab or placebo subcutaneously.|||Participants|||Count of Participants
2557383|NCT02709486|Secondary|Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24|In case of inadequate pain relief, acetaminophen/paracetamol up to 4000 mg per day up to 5 days in a week could be taken as rescue medication. The total dosage of acetaminophen in milligrams used during the specified week were summarized.|Weeks 2, 4, 8, 12, 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).|||milligrams||Standard Error|Least Squares Mean
2557384|NCT02709486|Secondary|Number of Days of Rescue Medication Used at Week 32|In case of inadequate pain relief, after Week 24, acetaminophen/paracetamol up to 4000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of days per week the participants used the rescue medication during the 4 weeks up to and including the particular study week were summarized.|Week 32|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Overall number of participants analyzed’ signifies participants who took rescue medication.|||days||Standard Deviation|Mean
2557385|NCT02709486|Secondary|Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24|In case of inadequate pain relief during the treatment period, acetaminophen/paracetamol up to 4000 mg per day up to 5 days in a week a could be taken as rescue medication. Number of days the participants used the rescue medication during the particular study weeks were summarized.|Weeks 2, 4, 8, 12, 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).|||days||Standard Error|Least Squares Mean
2557386|NCT02709486|Secondary|Number of Participants Who Took Rescue Medication During Week 32|In case of inadequate pain relief, after Week 24, acetaminophen/paracetamol up to 4000 mg per day up to 5 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of participants with any use of rescue medication during the 4 weeks up to and including the particular study week were summarized.|Week 32|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Overall number of participants analyzed’ signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2557387|NCT02709486|Secondary|Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24|In case of inadequate pain relief, acetaminophen/paracetamol up to 4000 mg per day up to 5 days in a week could be taken as rescue medication between day 1 and week 24. Number of participants with any use of rescue medication during the particular study week were summarized.|Weeks 2, 4, 8, 12, 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).|||Participants|||Count of Participants
2557388|NCT02709486|Secondary|Time to Discontinuation Due to Lack of Efficacy|Time to discontinuation due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy.|Baseline up to Week 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Overall number of participants analyzed’ signifies participants who discontinued from the study due to lack of efficacy.|||days||Full Range|Median
2557389|NCT02709486|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy|Number of participants who withdrew from treatment due to lack of efficacy have been reported here.|Baseline up to Week 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).|||Participants|||Count of Participants
2557390|NCT02709486|Secondary|Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis|Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 32 and Week 48. Domain evaluated was duration since quitting job due to OA.|Baseline, Weeks 32 and 48|ITT population: all randomized participants who received at least one dose of SC study medication (either Tanezumab or placebo). One additional participant apart from the ones who had responded for quitting job responded to duration since quitting job. ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||years||Full Range|Median
2557391|NCT02709486|Secondary|Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis|Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 32 and Week 48. Domain evaluated was number of participants who quit job due to OA.|Baseline, Weeks 32 and 48|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||Participants|||Count of Participants
2557392|NCT02709486|Secondary|Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things|Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Domain evaluated was number of participants who used any aids/devices for doing things. Aids such as walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices.|Baseline, Weeks 32 and 48|The intent to treat (ITT) population included all randomized participants who received at least one dose of subcutaneous (SC) study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||Participants|||Count of Participants
2557395|NCT02709486|Secondary|Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis|Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Domain evaluated was number of visits to the emergency room due to OA.|Baseline, Weeks 32 and 48|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||visits||Full Range|Median
2557396|NCT02709486|Secondary|Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis|Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Domain evaluated was number of participants who visited the emergency room due to osteoarthritis.|Baseline, Weeks 32 and 48|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||Participants|||Count of Participants
2557397|NCT02709486|Secondary|Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis|Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Visits of services directly related to osteoarthritis evaluated were: visits to primary care physician, neurologist, rheumatologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, podiatrist, nutritionist/dietitian, radiologist, home healthcare services and other practitioner.|Baseline, Weeks 32 and 48|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||visits||Full Range|Median
2557398|NCT02709486|Secondary|Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Osteoarthritis Pain?|The mPRTI is a self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction), participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess Patient willingness to use drug again, participants responded using interactive response technology (IRT) on a 5 point likert scale from 1-5, where, 1= yes, I would definitely want to use the same drug again, 2= I might want to use the same drug again, 3= I am not sure, 4= I might not want to use the same drug again, 5= no, I definitely would not want to use the same drug again. Higher scores indicate lesser willingness to use the investigational product.|Weeks 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time point.|||Participants|||Count of Participants
2557399|NCT02709486|Secondary|Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment?|The mPRTI is a self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction), participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess preference to continue using the investigational product, participants responded using interactive response technology (IRT) on a 5 point likert scale from 1-5, where, 1= yes, I definitely prefer the drug that I am receiving now, 2= I have a slight preference for the drug that I am receiving now, 3= I have no preference either way, 4= I have a slight preference for my previous treatment, 5= No, I definitely prefer my previous treatment. Higher scores indicate lesser preference to use the investigational product.|Weeks 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time point.|||Participants|||Count of Participants
2557400|NCT02709486|Secondary|Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling?|The mPRTI is a self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction), participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess previous treatment, participants responded for, 1=injectable prescription medicines, 2=prescription medicines taken by mouth, 3=surgery, 4=prescription medicines and surgery and 5=no treatment.|Weeks 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time point.|||Participants|||Count of Participants
2557401|NCT02709486|Secondary|Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study?|The mPRTI is a self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction), participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. For participant satisfaction, participants responded using interactive response technology (IRT) on a 5 point likert scale from 1-5, where 1=extremely dissatisfied, 2=dissatisfied, 3=neither satisfied nor dissatisfied, 4=satisfied and 5=extremely satisfied. Higher scores indicated greater satisfaction.|Weeks 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time point.|||Participants|||Count of Participants
2557837|NCT02702193|Secondary|Trajectory of Fatigue of Participants|Self-reported experience with fatigue over the past 7 days as measured by the PROMIS 29 fatigue subscale. Each item is scored 1-5, yielding a total between 5 and 20.|baseline, 4, 8 and 12 months|Intent to Treat analysis|||Participants|||Count of Participants
2557402|NCT02709486|Secondary|European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value|EQ-5D-5L: standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D health state profile comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Responses from the five domains were used to calculate a single utility index (the Overall health utility score) where values are less than equal to (<=) 1. The Overall health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a participant reports greater levels of problems across the five dimensions.|Baseline, Weeks 8, 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||units on a scale||Standard Deviation|Mean
2557403|NCT02709486|Secondary|European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score|EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a participant reports greater levels of problems across the five dimensions.|Baseline, Weeks 8, 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||units on a scale||Standard Deviation|Mean
2557404|NCT02709486|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24|WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline, Weeks 8, 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||units on a scale||Standard Error|Least Squares Mean
2557405|NCT02709486|Secondary|Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline|WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||units on a scale||Standard Deviation|Mean
2557406|NCT02709486|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Going Up or Downstairs) at Week 32|"WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when going up or down the stairs? Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain."|Baseline, Week 32|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||units on a scale||Standard Deviation|Mean
2557407|NCT02709486|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Going Up or Downstairs) at Weeks 2, 4, 8, 12, 16 and 24|"WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when going up or down the stairs? Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain."|Baseline, Weeks 2, 4, 8, 12, 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2557408|NCT02709486|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 32|"WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when walking on a flat surface?. Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain."|Baseline, Week 32|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||units on a scale||Standard Deviation|Mean
2557409|NCT02709486|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, 16 and 24|"WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when walking on a flat surface?. Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain."|Baseline, Weeks 2, 4, 8, 12, 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2557410|NCT02709486|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 32|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.|Baseline, Week 32|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
2557411|NCT02709486|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.|Baseline, Weeks 2, 4, 8, 12, 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2557412|NCT02709486|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 32|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on a NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.|Baseline, Week 32|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||units on a scale||Standard Deviation|Mean
2557413|NCT02709486|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.|Baseline, Weeks 2, 4, 8, 12, 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2557414|NCT02709486|Secondary|Change From Baseline for Average Pain Score in the Index Joint at Weeks 28 and 32|Participants assessed their average pain in the index hip/knee in the past 24 hours using a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data represents averages of the values reported during the 8-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.|Baseline, Weeks 28 and 32|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||units on a scale||Standard Deviation|Mean
2557415|NCT02709486|Secondary|Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24|Participants assessed their average pain in the index hip/knee in the past 24 hours using a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data represents averages of the values reported during the 8-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.|Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2557416|NCT02709486|Secondary|Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis|"PGA of OA was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where, 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition. Percentage of participants with improvement of at least 2 points from Baseline in PGA of OA were reported. Missing data was imputed using mixed BOCF/LOCF."|Weeks 2, 4, 8, 12, 16, 24 and 32|ITT population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here ‘Overall number of participants analyzed’ = participants who were evaluable for this outcome measure and ‘Number analyzed’ = participants evaluable for this outcome measure at specified time points.|||percentage of participants|||Number
2557417|NCT02709486|Secondary|Percentage of Participants With Cumulative Percent Change From Baseline Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24|Percentage of participants with cumulative reduction (as percent) (greater than 0 %; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; =100 %) in WOMAC physical function subscale from Baseline to Weeks 16 and 24 were reported. WOMAC:Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function: participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale:17-item questionnaire to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), higher scores indicate extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.|Baseline, Weeks 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Overall number of participants analyzed’ = Participants evaluable for this outcome measure.|||percentage of participants|||Number
2557418|NCT02709486|Secondary|Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response|Percentage of participants with reduction in WOMAC physical function of at least (>=)30%,50%,70% and 90% at weeks 2,4,8,12,16,24 and 32 compared to baseline were classified as responders to WOMAC physical function subscale. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function:Participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee/hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.|Weeks 2, 4, 8, 12, 16, 24 and 32|ITT population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here ‘Overall number of participants analyzed’ = participants who were evaluable for this outcome measure and ‘Number analyzed’ = participants evaluable for this outcome measure at specified time points.|||percentage of participants|||Number
2557419|NCT02709486|Secondary|Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response|Percentage of participants with reduction in WOMAC pain intensity of at least (>=) 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 12, 16, 24 and 32 compared to baseline were classified as responders to WOMAC pain subscale and are reported here. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Missing data was imputed using mixed BOCF/LOCF.|Week 2, 4, 8, 12, 16, 24 and 32|ITT population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here ‘Overall number of participants analyzed’ = participants who were evaluable for this outcome measure and ‘Number analyzed’ = participants evaluable for this outcome measure at specified time points.|||percentage of participants|||Number
2557420|NCT02709486|Secondary|Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24|WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than 0% ; >= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in WOMAC pain subscale from Baseline to Weeks 16 and 24 were reported, participants (%) are reported more than once in categories specified. Missing data was imputed using mixed BOCF/LOCF.|Baseline, Weeks 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Overall number of participants analyzed’ = Participants evaluable for this outcome measure.|||percentage of Participants|||Number
2557907|NCT02701361|Secondary|Change in Distress Associated With Physical Symptoms|The PHQ-10 (Patient Health Questionnaire) was used to measure distress associated with physical symptoms (range 0 [none] to 30 [very troublesome]).|Between randomization and 3 months post-randomization||||units on a scale||95% Confidence Interval|Mean
2557421|NCT02709486|Secondary|Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index|Participants were considered as OMERACT-OARSI responders: if the change (improvement) from baseline to week of interest was greater than or equal to (>=) 50 percent and >= 2 units in either WOMAC pain subscale or physical function subscale score; if change (improvement) from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [extreme difficulty], higher score = worse physical function) and PGA of OA (score: 1 [very good] to 5 [very poor], higher score = worse condition). Missing data was imputed using mixed baseline/last observation carried forward (BOCF/LOCF).|Weeks 2, 4, 8, 12, 16, 24 and 32|ITT population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here ‘Overall number of participants analyzed’ = participants who were evaluable for this outcome measure and ‘Number analyzed’ = participants evaluable for this outcome measure at specified time points.|||percentage of participants|||Number
2557422|NCT02709486|Secondary|Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 32|"PGA of OA was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition."|Baseline, Week 32|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
2557423|NCT02709486|Secondary|Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16|"PGA of OA was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities)."|Baseline, Weeks 2, 4, 8, 12 and 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2557424|NCT02709486|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 32|WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.|Baseline, Week 32|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
2557425|NCT02709486|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16|WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.|Baseline, Weeks 2, 4, 8, 12 and 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2557426|NCT02709486|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 32|WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.|Baseline, Week 32|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
2557438|NCT02709369|Secondary|Drop Stick Reaction Testing|Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100.|enrollment visit/baseline|Drop stick reaction testing was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.|||cm||Standard Deviation|Mean
2557427|NCT02709486|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16|WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.|Baseline, Weeks 2, 4, 8, 12 and 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2557428|NCT02709486|Primary|Change From Baseline in the Patient's Global Assessment (PGA) of Osteoarthritis at Week 24|"PGA of OA was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition."|Baseline, Week 24|The intent to treat population was defined as all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2557429|NCT02709486|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24|WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.|Baseline, Week 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2557430|NCT02709486|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24|WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.|Baseline, Week 24|The intent to treat (ITT) population included all randomized participants who received at least one dose of subcutaneous (SC) study medication (either tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2557431|NCT02709369|Other Pre-specified|Baroreflex Sensitivity Sequence All|Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.|4-8 weeks after completion of the intervention|||||||
2557432|NCT02709369|Other Pre-specified|Baroreflex Sensitivity Sequence Down|Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.|4-8 weeks after completion of the intervention|||||||
2557433|NCT02709369|Other Pre-specified|Baroreflex Sensitivity Sequence Up|Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.|4-8 weeks after completion of the intervention|||||||
2557434|NCT02709369|Other Pre-specified|Baroreflex Sensitivity High Frequency (HF) Alpha|Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.|4-8 weeks after completion of the intervention|||||||
2557435|NCT02709369|Other Pre-specified|Heart Rate Variability Standard Deviation of NN Intervals (SDNN)|Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval|4-8 weeks after completion of the intervention|||||||
2557436|NCT02709369|Secondary|Drop Stick Reaction Testing|Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100.|4-8 weeks after completion of the intervention|Drop stick reaction testing was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.|||cm||Standard Deviation|Mean
2557437|NCT02709369|Secondary|Drop Stick Reaction Testing|Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100.|1-2 weeks after the intervention is completed|Drop stick reaction testing was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.|||cm||Standard Deviation|Mean
2557466|NCT02709369|Primary|Heart Rate Variability Standard Deviation of NN Intervals (SDNN)|Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval|Baseline/Enrollment visit|BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.|||milliseconds||Standard Deviation|Mean
2557439|NCT02709369|Secondary|Rivermead Post-Concussion Symptoms Questionnaire (RPQ)|The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity.|4-8 weeks after completion of the intervention|Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported TBI or concussion on medical history form. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.|||score on a scale||Standard Deviation|Mean
2557440|NCT02709369|Secondary|Rivermead Post-Concussion Symptoms Questionnaire (RPQ)|The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with a higher score denoting the greatest symptom severity.|1-2 weeks after the intervention is completed|Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported TBI or concussion on medical history form.|||score on a scale||Standard Deviation|Mean
2557441|NCT02709369|Secondary|Rivermead Post-Concussion Symptoms Questionnaire (RPQ)|The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity.|enrollment visit/baseline|Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported TBI or concussion on medical history form.|||score on a scale||Standard Deviation|Mean
2557442|NCT02709369|Secondary|Posttraumatic Stress Disorder Checklist (PCL)|The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.|4-8 weeks after completion of the intervention|Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported trauma or PTSD on medical history form. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.|||score on a scale||Standard Deviation|Mean
2557443|NCT02709369|Secondary|Posttraumatic Stress Disorder Checklist (PCL)|The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.|1-2 weeks after the intervention is completed|Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported trauma or PTSD on medical history form.|||score on a scale||Standard Deviation|Mean
2557444|NCT02709369|Secondary|Posttraumatic Stress Disorder Checklist (PCL-C)|The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.|enrollment visit/baseline|Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported trauma or PTSD on medical history form.|||score on a scale||Standard Deviation|Mean
2557445|NCT02709369|Secondary|Insomnia Severity Index (ISI)|The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality.|4-8 weeks after completion of the intervention|Entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.|||score on a scale||Standard Deviation|Mean
2557446|NCT02709369|Secondary|Insomnia Severity Index (ISI)|The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality.|1-2 weeks after the intervention is completed|Entries were excluded if there was incomplete or missing data.|||score on a scale||Standard Deviation|Mean
2557447|NCT02709369|Secondary|Insomnia Severity Index (ISI)|The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality.|enrollment visit/baseline|Entries were excluded if there was incomplete or missing data.|||score on a scale||Standard Deviation|Mean
2557448|NCT02709369|Secondary|Generalized Anxiety Disorder-7 (GAD-7)|The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.|4-8 weeks after completion of the intervention|GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.|||score on a scale||Standard Deviation|Mean
2557449|NCT02709369|Secondary|Generalized Anxiety Disorder-7 (GAD-7)|The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.|1-2 weeks after the intervention is completed|GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.|||score on a scale||Standard Deviation|Mean
2557450|NCT02709369|Secondary|Generalized Anxiety Disorder-7 (GAD-7)|The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.|enrollment visit/baseline|GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.|||score on a scale||Standard Deviation|Mean
2557467|NCT02709330|Secondary|ALSFRS-R Accuracy|To confirm that participants can accurately measure their own ALS Functional Rating Scale (Revised, ALSFRS-R), the investigators will compare the ALSFRS-R obtained by the coordinator with that obtained by the participants themselves at the Month 1 Visit. Correlational analysis between these 2 scores will be performed with Spearman's rho.|Month 1|2 participants did not provide month 1 scores.|||percentage of accuracy||95% Confidence Interval|Mean
2557451|NCT02709369|Secondary|Euro Quality of Life--Five Dimension (EQ-5D)|The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome.|4-8 weeks after completion of the intervention|EQ-5D was added as a study measure at subject 79. Entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.|||score on a scale||Standard Deviation|Mean
2557452|NCT02709369|Secondary|Euro Quality of Life--Five Dimension (EQ-5D)|The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome.|1-2 weeks after the intervention is completed|EQ-5D was added as a study measure at subject 79. Entries were excluded if there was incomplete or missing data.|||score on a scale||Standard Deviation|Mean
2557453|NCT02709369|Secondary|Euro Quality of Life--Five Dimension (EQ-5D)|The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome.|enrollment visit/baseline|EQ-5D was added as a study measure at subject 79. Entries were excluded if there was incomplete or missing data.|||score on a scale||Standard Deviation|Mean
2557454|NCT02709369|Secondary|Center for Epidemiologic Studies Depression Scale (CES-D)|The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology.|4-8 weeks after completion of the intervention|CES-D was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections.|||score on a scale||Standard Deviation|Mean
2557455|NCT02709369|Secondary|Center for Epidemiologic Studies Depression Scale (CES-D)|The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology.|1-2 weeks after intervention is completed|CES-D was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.|||score on a scale||Standard Deviation|Mean
2557456|NCT02709369|Secondary|Center for Epidemiologic Studies Depression Scale (CES-D)|The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology.|enrollment visit/baseline|CES-D was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data.|||score on a scale||Standard Deviation|Mean
2557457|NCT02709369|Primary|Baroreflex Sensitivity Sequence All|Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.|Up to 2 weeks after the intervention is completed|BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.|||ms/mmHg||Standard Deviation|Mean
2557458|NCT02709369|Primary|Baroreflex Sensitivity Sequence All|Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.|Baseline/Enrollment visit|BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.|||ms/mmHg||Standard Deviation|Mean
2557459|NCT02709369|Primary|Baroreflex Sensitivity Sequence Down|Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.|Up to two weeks after the intervention is completed|BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.|||ms/mmHg||Standard Deviation|Mean
2557460|NCT02709369|Primary|Baroreflex Sensitivity Sequence Down|Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.|Baseline/Enrollment visit|BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.|||ms/mmHg||Standard Deviation|Mean
2557461|NCT02709369|Primary|Baroreflex Sensitivity Sequence Up|Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.|Up to two weeks after the intervention is completed|BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.|||ms/mmHg||Standard Deviation|Mean
2557462|NCT02709369|Primary|Baroreflex Sensitivity Sequence Up|Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.|Baseline/Enrollment visit|BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.|||ms/mmHg||Standard Deviation|Mean
2557463|NCT02709369|Primary|Baroreflex Sensitivity High Frequency (HF) Alpha|Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.|Up to two weeks after the intervention is completed|BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.|||ms^2||Standard Deviation|Mean
2557464|NCT02709369|Primary|Baroreflex Sensitivity High Frequency (HF) Alpha|Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.|Baseline/Enrollment visit|BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.|||ms^2||Standard Deviation|Mean
2557465|NCT02709369|Primary|Heart Rate Variability (SDNN)|Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval|Up to 2 weeks after the intervention is completed|BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats.|||milliseconds||Standard Deviation|Mean
2557471|NCT02709330|Secondary|Percent Agreement Between the Weights Obtained by Patients and Study Coordinator|To confirm that participants can accurately measure their own weight, even as they become more disabled by ALS, the investigators will compare the participant-generated weight with the weight obtained by the study coordinator at the Month 1 and Month 12 visits. A simple description of the accuracy (percent agreement between the weights) will be used.|Month 1, Month 12|Participants with both self-obtained weight and weight obtained by the study coordinator available.|||percentage of agreement||95% Confidence Interval|Number
2557472|NCT02709330|Secondary|Change in H3 Histone Acetylation|Participants, ALS controls (not on Lunasin) and healthy controls (not on Lunasin) had blood drawn at baseline and 1 month time points. Histones were extracted from blood cells. Western blots were used to look at specific histone acetylation patterns that Lunasin had reportedly altered in cell cultures (H3K9K14ac2 and H4K5K8K12K16). Integrated density values for AcH3 protein bands were normalized for total H3. Percent H3 values for the 1 month time point were normalized to that of the baseline visit. Results were analyzed by one-way ANOVA.|Screening/baseline, Month 1|Lunasin regimen: 20 of 50 enrolled participants did not have sufficient sample. Five ALS control subjects (not on Lunasin) and five healthy control subjects (not on Lunasin) were also consented specifically for this analysis. One of the healthy controls did not have sufficient sample.|||percentage of baseline||Standard Deviation|Mean
2557473|NCT02709330|Primary|Change in Revised ALS Functional Rating Scale (ALSFRS-R)|ALSFRS-R is a quickly administered (five minute) ordinal rating scale used to determine patient's assessment of their capability and independence in 13 functional activities. All 13 activities are relevant in ALS. Each task is rated on a five-point scale from 0 = can't do, to 4 = normal ability, with a total score of 52 points. Reported is the rate of change in total points per month.|Screening/baseline - 12 months|1 participant deleted PLM account; 2 others did not enter ALSFRS-R data.|||points per month||Standard Deviation|Mean
2557474|NCT02709096|Primary|Logarithmic Change in Colony Counts of Facial Propionibacterium Acnes|P. Acnes cultures will be collected using the modified Kligman Method at each study visit. After plating, the samples will be cultured for 7 days and then evaluated.|Cultures will be evaluated at Baseline, Week 1, Week 2, Week 4 and Week 6. Values reported at week 4 compared to baseline.|Per protocol population included all subjects with evaluable data and no major protocol violations.|||log change in colony forming units||Standard Deviation|Mean
2557475|NCT02709083|Secondary|The Number of Subjects With Breakpoint Cluster Region-abelson Murine Leukemia Viral Oncogene Homolog 1 (BCR-ABL1) Transcript Levels ≤ Deep Molecular Responses (MR⁴)|Descriptive statistics will summarize the changes in breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL1) testing over time will be presented.|Up to 24 months|Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University.||||||
2557476|NCT02709083|Secondary|Severity of Adverse Events (AEs) Using the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Criteria|Listings of laboratory test results will also be generated, and descriptive statistics summarizing the changes in laboratory tests over time will be presented. Exposure to drug over time will also be summarized. The AE incidence rates, as well as the frequency of occurrence of overall toxicity, categorized by toxicity grades (severity) will be described as obtained from subject forms and subject communications.|Up to 30 days after the end-of-treatment|Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University.||||||
2557477|NCT02709083|Secondary|Progression Free Survival (PFS)|Progression free survival (PFS) will be defined as the time from CML diagnosis to the time of loss of major molecular response (MMR) or loss of hematologic response.|The time of CML diagnosis to the time of loss of MMR or loss of hematologic response, assessed up to 24 months|Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University.||||||
2557478|NCT02709083|Secondary|Frequency of Adverse Events (AEs) Using the Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE v4.03) Criteria|Listings of laboratory test results will also be generated, and descriptive statistics summarizing the changes in laboratory tests over time will be presented. Exposure to drug over time will also be summarized. The AE incidence rates, as well as the frequency of occurrence of overall toxicity, categorized by toxicity grades (severity) will be described as obtained from subject forms and subject communications.|Up to 30 days after the end-of-treatment|Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University.||||||
2557479|NCT02709083|Secondary|Duration of Adverse Events (AEs) Using the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Criteria|Listings of laboratory test results will also be generated, and descriptive statistics summarizing the changes in laboratory tests over time will be presented. Exposure to drug over time will also be summarized. The AE incidence rates, as well as the frequency of occurrence of overall toxicity, categorized by toxicity grades (severity) will be described as obtained from subject forms and subject communications.|Up to 30 days after the end-of-treatment|Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University.||||||
2557480|NCT02709083|Secondary|Change in Patient Reported Outcomes (PRO) Score Extracted From the MD Anderson Symptom Inventory-Chronic Myelogenous Leukemia (CML)|The patient reported outcomes (PRO) score extracted from the MD Anderson Symptom Inventory (MDASI)-Chronic Myelogenous Leukemia (CML) will be determined and intra and inter subject changes will be compared.|Baseline to up to 12 months|Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University.||||||
2557481|NCT02709083|Secondary|Accelerated Phase (AP) or Blast Phase (BP) Free Survival|Survival will be defined as the time from CML diagnosis to the time of transformation to accelerated phase (AP) or blast phase (BP).|The time of CML diagnosis to the time of transformation to AP or BP, assessed up to 24 months|Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University.||||||
2557482|NCT02709083|Primary|The Proportion of Subjects Who Achieve Major Molecular Response (MMR)|Response will be measured by a decrease in fusion transcript or protein resulting from the 9;22 chromosomal translocation responsible for formation of the Philadelphia Chromosome (BCR-ABL1) levels on a logarithmic scale. A 1 log reduction is a drop to below 10%, while a major molecular response (MMR) is defined as a 3 log reduction (0.1%).|At 12 months|Data not collected since trial closed early; original study principal investigator Vamsi Kota, MD, left Emory University.||||||
2557483|NCT02709005|Secondary|Number of Participants Experiencing Laboratory AEs Following the First Dose of the Study Product|The number of participants experiencing laboratory AEs following the first dose of the study product was assessed at Visit 2 (Day 8-15). A laboratory abnormality was considered an adverse event if there was a worsening of the laboratory value at Visit 2 from the baseline value and it increased in laboratory toxicity grading from the baseline toxicity grading. Protocol-defined hematology parameters assessed were white blood cells, hemoglobin, platelets, and neutrophils. Protocol-defined clinical chemistry parameters assessed were creatinine, AST, ALT, total bilirubin, and glucose (random).|Visit 2 (Day 8-15)|The safety population includes all randomized participants who received at least one dose of study treatment. In the event of an error in randomization or study product administration (i.e., incorrect product), participants were grouped by the product they actually received.|||Participants|||Count of Participants
2557484|NCT02709005|Secondary|Number of Participants Experiencing Non-laboratory Non-solicited AEs Following the First Dose of the Study Product|The number of participants who experienced non-laboratory, non-solicited AEs following the first dose of the study product through Visit 3 (Day 22-31) was assessed. Events involving laboratory parameters that were not collected as part of the protocol were counted as non-laboratory, non-solicited adverse events.|Visit 1 (Day 1) through Visit 3 (Day 22-31)|The safety population includes all randomized participants who received at least one dose of study treatment. In the event of an error in randomization or study product administration (i.e., incorrect product), participants were grouped by the product they actually received.|||Participants|||Count of Participants
2557485|NCT02709005|Secondary|Number of Participants With Clinical Cure in Each Study Arm|"A clinical cure was defined by normal Amsel criteria, including: normal physiological vaginal discharge, whiff test negative for any amine fishy odor, saline wet mount less than 20% for clue cells, and vaginal pH is <=4.5. All four criteria had to be normal with none of the clinical failure criteria met to be considered a clinical cure. A clinical failure was defined by at least one of the following: one or more abnormal Amsel criteria, early discontinuation of study therapy due to lack of treatment effect, use of any vaginosis therapy other than study product during the study, or in the investigator's opinion, requires additional treatment for vaginosis. Participants who did not have enough information to determine a clinical cure or clinical failure status were not evaluable for clinical cure."|Visit 3 (Day 22-31)|The mITT population includes randomized participants who met inclusion/exclusion criteria, excluding those with Nugent score <4 at Visit 1 or a positive Visit 1 HIV, Chlamydia, or Neisseria gonorrhoeae test. In the event of an error in randomization or study product administration, participants were grouped by their intended randomized assignment.|||Participants|||Count of Participants
2557486|NCT02709005|Secondary|Number of Participants With Nugent Score of 4-6 (Intermediate BV) in Each Study Arm|A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score utilizes a 10-point scale for evaluation of vaginal flora. The Nugent score can range from 0 to 10. A score of 7 to 10 is consistent with BV while 4-6 is considered intermediate and 0-3 is negative for BV. Bacteriological cure of BV was defined as a normal Nugent score of 0-3.|Visit 3 (Day 22-31)|The mITT population includes randomized participants who met inclusion/exclusion criteria, excluding those with Nugent score <4 at Visit 1 or a positive Visit 1 HIV, Chlamydia, or Neisseria gonorrhoeae test. In the event of an error in randomization or study product administration, participants were grouped by their intended randomized assignment.|||Participants|||Count of Participants
2557487|NCT02709005|Secondary|Number of Participants With Nugent Score of 4-6 (Intermediate BV) in Each Study Arm|A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score utilizes a 10-point scale for evaluation of vaginal flora. The Nugent score can range from 0 to 10. A score of 7 to 10 is consistent with BV while 4-6 is considered intermediate and 0-3 is negative for BV. Bacteriological cure of BV was defined as a normal Nugent score of 0-3.|Visit 2 (Day 8-15)|The mITT population includes randomized participants who met inclusion/exclusion criteria, excluding those with Nugent score <4 at Visit 1 or a positive Visit 1 HIV, Chlamydia, or Neisseria gonorrhoeae test. In the event of an error in randomization or study product administration, participants were grouped by their intended randomized assignment.|||Participants|||Count of Participants
2557488|NCT02709005|Secondary|Number of Participants With Nugent Score of 3 or Less (Negative for BV) in Each Study Arm|A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score utilizes a 10-point scale for evaluation of vaginal flora. The Nugent score can range from 0 to 10. A score of 7 to 10 is consistent with BV while 4-6 is considered intermediate and 0-3 is negative for BV. Bacteriological cure of BV was defined as a normal Nugent score of 0-3.|Visit 3 (Day 22-31)|The mITT population includes randomized participants who met inclusion/exclusion criteria, excluding those with Nugent score <4 at Visit 1 or a positive Visit 1 HIV, Chlamydia, or Neisseria gonorrhoeae test. In the event of an error in randomization or study product administration, participants were grouped by their intended randomized assignment.|||Participants|||Count of Participants
2557489|NCT02709005|Secondary|Number of Participants With Nugent Score of 3 or Less (Negative for BV) in Each Study Arm|A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score utilizes a 10-point scale for evaluation of vaginal flora. The Nugent score can range from 0 to 10. A score of 7 to 10 is consistent with BV while 4-6 is considered intermediate and 0-3 is negative for BV. Bacteriological cure of BV was defined as a normal Nugent score of 0-3.|Visit 2 (Day 8-15)|The mITT population includes randomized participants who met inclusion/exclusion criteria, excluding those with Nugent score <4 at Visit 1 or a positive Visit 1 HIV, Chlamydia, or Neisseria gonorrhoeae test. In the event of an error in randomization or study product administration, participants were grouped by their intended randomized assignment.|||Participants|||Count of Participants
2557496|NCT02708745|Secondary|Provider Perceptions of Barriers to the Vaccine Discussion|Provider-reported ratings of the significance of 3 barriers to the vaccine discussion: a) not having enough time to discuss parental vaccine concerns, b) not realizing until late in the visit that a parent had vaccine concerns, and c) not understanding a parent's specific vaccine concerns to be barriers pre- and post-intervention|Change post-intervention from pre-intervention|Proportion in arm who rated barrier as significant (3-5 on a 1-5 scale, where 1=not at all significant and 5=very significant)|||Participants|||Count of Participants
2558804|NCT02688842|Secondary|Participants With Target Lesion Failure|a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)|6months after stent implantation||||Participants|||Count of Participants
2557490|NCT02709005|Secondary|Number of Participants With Therapeutic Cure in Each Study Arm|"Therapeutic cure was defined as both a clinical cure and a bacteriological cure. All four Amsel criteria had to be normal with none of the clinical failure criteria listed met to be considered a clinical cure, including normal physiological vaginal discharge, whiff test negative for any amine fishy odor, saline wet mount less than 20% for clue cells, and vaginal pH is <=4.5. A clinical failure was defined by at least one of the following: one or more abnormal Amsel criteria, early discontinuation of study therapy due to lack of treatment effect, use of any vaginosis therapy other than study product during the study, or in the investigator's opinion, required additional treatment for vaginosis. A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-3. Participants who were clinical failures, or had a Nugent score >3 were therapeutic failures."|Visit 3 (Day 22-31)|The mITT population includes randomized participants who met inclusion/exclusion criteria, excluding those with Nugent score <4 at Visit 1 or a positive Visit 1 HIV, Chlamydia, or Neisseria gonorrhoeae test. In the event of an error in randomization or study product administration, participants were grouped by their intended randomized assignment.|||Participants|||Count of Participants
2557491|NCT02709005|Secondary|Number of Participants With Therapeutic Cure in Each Study Arm|"Therapeutic cure was defined as both a clinical cure and a bacteriological cure. All four Amsel criteria had to be normal with none of the clinical failure criteria listed met to be considered a clinical cure, including normal physiological vaginal discharge, whiff test negative for any amine fishy odor, saline wet mount less than 20% for clue cells, and vaginal pH is <=4.5. A clinical failure was defined by at least one of the following: one or more abnormal Amsel criteria, early discontinuation of study therapy due to lack of treatment effect, use of any vaginosis therapy other than study product during the study, or in the investigator's opinion, required additional treatment for vaginosis. A vaginal swab for bacteriological assessment of BV by Nugent criteria was performed. The Nugent score can range from 0 to 10. Bacteriological cure of BV was defined as a normal Nugent score of 0-3. Participants who were clinical failures, or had a Nugent score >3 were therapeutic failures."|Visit 2 (Day 8-15)|The mITT population includes randomized participants who met inclusion/exclusion criteria, excluding those with Nugent score <4 at Visit 1 or a positive Visit 1 HIV, Chlamydia, or Neisseria gonorrhoeae test. In the event of an error in randomization or study product administration, participants were grouped by their intended randomized assignment.|||Participants|||Count of Participants
2557492|NCT02709005|Primary|Number of Participants Reporting Serious Adverse Events (SAEs) Considered Product-related|"The number of participants in each treatment group with product-related SAEs was assessed. An AE was considered serious if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, or a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalizations could be considered serious when, based upon appropriate medical judgment, they could jeopardize the participant and require medical or surgical intervention to prevent one of the outcomes listed. An AE was considered related if there was a reasonable possibility that the study product caused the AE, meaning that there is evidence to suggest a causal relationship between the study product and the AE."|Visit 1 (Day 1) through Visit 3 (Day 22-31)|The safety population includes all randomized participants who received at least one dose of study treatment. In the event of an error in randomization or study product administration (i.e., incorrect product), participants were grouped by the product they actually received.|||Participants|||Count of Participants
2557493|NCT02709005|Primary|Number of Participants Reporting Solicited Urogenital Adverse Events (AEs) Following the First Dose of the Study Product|Solicited event assessments were captured on a memory aid starting on Day 1, the first day of therapy and continuing for 5 days. The participant recorded the presence and intensity of vulvovaginal solicited events on the memory aid. Any symptom that was present at the time that the participant was screened was considered as baseline and not reported as a solicited urogenital AE. However, if the symptom deteriorated during the reporting period, it was considered an AE. If a symptom was reported that was not present at baseline, it too was considered an AE. Any symptoms still present on Day 5 were followed by participant memory aid notations until symptom resolution. Solicited events collected include vaginal odor, vaginal pain, vaginal tenderness, vaginal itching, vaginal dryness, vaginal discharge, and vaginal inflammation. Severity of solicited events symptoms were graded as mild, moderate, or severe according to the grading table in the protocol.|Days 1 through 5|The safety population includes all randomized participants who received at least one dose of study treatment. If a subject did not have solicited symptom data she was not included. In the event of an error in randomization or study product administration (i.e., incorrect product), participants were grouped by the product they actually received.|||Participants|||Count of Participants
2557494|NCT02709005|Primary|Number of Participants With Clinical Cure in Each Study Arm|"A clinical cure was defined by normal Amsel criteria, including: normal physiological vaginal discharge, whiff test negative for any amine fishy odor, saline wet mount less than 20% for clue cells, and vaginal pH is <=4.5. All four criteria had to be normal with none of the clinical failure criteria met to be considered a clinical cure. A clinical failure was defined by at least one of the following: one or more abnormal Amsel criteria, early discontinuation of study therapy due to lack of treatment effect, use of any vaginosis therapy other than study product during the study, or in the investigator's opinion, required additional treatment for vaginosis."|Visit 2 (Day 8-15)|The mITT population includes randomized participants who met inclusion/exclusion criteria, excluding those with Nugent score <4 at Visit 1 or a positive Visit 1 HIV, Chlamydia, or Neisseria gonorrhoeae test. In the event of an error in randomization or study product administration, participants were grouped by their intended randomized assignment.|||Participants|||Count of Participants
2557495|NCT02708862|Primary|Exhaled Oxygen Concentration|Subjects will blow into an oxygen sensor after each method (arm). The primary outcome will be a non-inferiority test between bag valve mask and non-rebreather at 60 L/min. The remaining tests will be completed for comparison, but not part of formal statistical testing.|Immediately after 3 minutes of oxygen supplementation||||% FeO2||95% Confidence Interval|Mean
2557537|NCT02707965|Secondary|Number of Adverse Events|summed for each anti-epileptic drug from when taking brand and generic.|Through the approximately 2 week period when the treatment is given.||||events|||Number
2557497|NCT02708745|Secondary|Number of Parents With a Highly Rated Visit Experience|Score on a 15-item parent-completed visit experience survey (minimum score 15; maximum score 105, with higher scores suggesting a higher rated visit experience)|24-48 hours after the 6 month health supervision visit|Proportion of parents with a highly-rated visit experience by study arm, defined as those who scored 90 or higher (out of 105) on the visit experience survey|||Participants|||Count of Participants
2557498|NCT02708745|Primary|Child's Mean Percent Days Under-immunized|Mean percent days under-immunized among children of parents who received (vs. did not receive) the intervention|Child's immunization status at 8 months of age|Mean percent days under-immunized of child participants by study arm|||percentage of days under-immunized||95% Confidence Interval|Mean
2557499|NCT02708524|Secondary|Overall Opinion Individual Item|Overall Opinion was assessed using a questionnaire item at Post Fit, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|Up to 1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||percentage of participants|||Number
2557500|NCT02708524|Secondary|Overall Quality of Vision Individual Item|Overall Quality of Vision was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the number of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|Up to 1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||percentage of participants|||Number
2557501|NCT02708524|Secondary|Subjective Overall Quality of Vision Composite Score|Subjective Overall Quality of Vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.|Up to 1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||units on a scale||Standard Deviation|Mean
2557502|NCT02708524|Primary|Making Your Eyes Feel Moist Throughout the Day Individual Item|Making your eyes feel moist throughout the day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|Up to 1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||percentage of participants|||Number
2557503|NCT02708524|Primary|Frequency of Experiencing Dryness Individual Item|Frequency of Experiencing Dryness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.|1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||percentage of participants|||Number
2557504|NCT02708524|Primary|Frequency of Lens Awareness Individual Item|Frequency of Lens Awareness was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are scaled as (Always, Frequently, Occasionally, Rarely, Never or Don't Know). Only the number of participants that reported Rarely or Never (Top-Two-Box) was reported here.|1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||percentage of participants|||Number
2557505|NCT02708524|Primary|Comfort Each and Everyday Individual Item|Comfort each and everyday was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||percentage of participants|||Number
2557506|NCT02708524|Primary|Comfort at the End of the Day Individual Item|Comfort at the End of the Day was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Reposes are on a 5 like-rt scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|1 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||percentage of participants|||Number
2557507|NCT02708524|Primary|Overall Comfort Individual Item|Overall Comfort was assessed using a questionnaire item at Baseline, 1-week, 2-week, 3-week and 4-week follow-up. Responses are on a 5 likert scale (Excellent, Very Good, Good, Fair and Poor). Only the percentage of participants that reported Excellent or Very good (Top-Two-Box) was reported here.|1 month follow-up|Subjects that completed all study visits without a major protocol deviation.|||percentage of participants|||Number
2557508|NCT02708524|Primary|Subjective Overall Comfort Composite Score|Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.Range is 0 to 120. CLUE was collect at Baseline, Post Lens Fit 1-, 2-, 3- and 4- week follow-ups.|Up to 1 month Follow-up|All subjects that completed all study visits without a major protocol deviation.|||average clue score||Standard Deviation|Mean
2557509|NCT02708485|Primary|Brain Acetoacetate Consumption|Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET imaging|3 months|Participants of the Control group discontinued the study because of the intense imaging protocol without the possibility of some level of benefit (N=3). Two participants in the Walking group decided to withdraw from the study prior to the commencement of the exercise program. There were no dropouts over the training period (N=10).|||umol/100 g/min||Standard Deviation|Mean
2557510|NCT02708485|Primary|Brain Glucose Consumption|Brain glucose uptake (umol/100g/min) using 18F-FDG PET imaging|3 months|Participants of the Control group discontinued the study because of the intense imaging protocol without the possibility of some level of benefit (N=3)|||umol/100 g/min||Standard Deviation|Mean
2557511|NCT02708433|Primary|Mean Time to Pulpal Response After Mandibular Canine Anesthesia|"Subject's Mandibular canine teeth will be tested before anesthetic and every 30 minutes after for response to Cold and Electronic Pulp Test for presence of anesthesia as reported by participants yes or no."|Every 30 minutes up to 120 minutes total||||Minutes||Standard Deviation|Mean
2557512|NCT02708433|Primary|Mean Time to Pulpal Response After Mandibular Molar Anesthesia|"Subject's Mandibular first molar teeth tested before anesthetic and every 30 minutes after for response to Cold and Electric Pulp Test as reported by subjects as a yes or no."|Every 30 minutes up to 120 minutes total||||Minutes||Standard Deviation|Mean
2557513|NCT02708355|Primary|Change From Baseline at Day 14 in Percentage of Time Over 24--Hour Period With Intra Gastric pH Greater Than (>)4|"Percentage of time was calculated over the 24 hour period during which intra gastric pH >4 was observed. Relief of 24 hour heartburn was defined as a daily diary response of 0 to the question Over the last 24 hours (yesterday and last night), what was the severity of your most intense episode of heartburn? on at least 6 of the participant's last 7 consecutive days [Days 8 - 14] of treatment allowing for one day with a maximum severity of 2.The response was noted by participants in the diary for last 7 consecutive days [Day 8 - 14] on a 3 point scale ranged from 0 to 2 where 0= complete relief and 2= maximum severity. Higher score indicated worse condition/more severity. In this outcome, change from baseline at Day 14 in percentage of time over the 24 hour period during which intra gastric pH >4 was observed, was reported."|Baseline, Day 14|Per protocol analysis set included all randomized participants who provided valid data for Day -1 PH monitoring, take at least one dose of randomized study medication, complete the 14 day treatment phase, undergo and provide valid data for Day 14 pH monitoring and complete at least 5 days of diary entries in each of Days -7 to -1 and Days 8 to 14.|||percentage of time||Standard Deviation|Mean
2557514|NCT02708355|Primary|Number of Participants With Relief of 24 Hour Heartburn and Without Relief of 24 Hour Heartburn|"Relief of 24 hour heartburn was defined as a daily diary response of 0 to the question Over the last 24 hours (yesterday and last night), what was the severity of your most intense episode of heartburn? on at least 6 of the participant's last 7 consecutive days [Days 8 - 14] of treatment allowing for one day with a maximum severity of 2.The response was noted by participants in the diary for last 7 consecutive days [Day 8 - 14] on a 3 point scale ranged from 0 to 2 where 0= complete relief and 2= maximum severity. Higher score indicated worse condition/more severity. In this outcome measure, participants with relief of 24 hour heartburn and participants without relief of 24 hour heartburn were reported."|Day 8 up to Day 14|Per protocol analysis set included all randomized participants who provided valid data for Day -1 PH monitoring, take at least one dose of randomized study medication, complete the 14 day treatment phase, undergo and provide valid data for Day 14 pH monitoring and complete at least 5 days of diary entries in each of Days -7 to -1 and Days 8 to 14.|||participants|||Number
2557515|NCT02708290|Primary|Reduction of Autism Severity as Measured by Autism Therapy Evaluation Checklist (ATEC). Reference: Rimland, B. & Edelson, S. Autism Research Institute. Autism Treat. Eval. Checkl. ATEC (1999)|Autism Therapy Evaluation Checklist (ATEC) is completed by parents every three months. ATEC is comprised of four subscales: 1) Speech/Language/Communication, 2) Sociability, 3) Sensory/Cognitive Awareness, and 4) Physical/Health/Behavior. The first subscale, Speech/Language/Communication, contains 14 items and its score ranges from 0 to 28 points. The Sociability subscale contains 20 items within a score range from 0 to 40 points. The third subscale, Sensory/Cognitive awareness, has 18 items and scores range from 0 to 36 points. Finally, the Health/Physical/Behavior subscale contains 25 items and scores range from 0 to 75 points. The scores from each subscale are combined in order to calculate a Total Score, which ranges from 0 to 179 points. A lower score indicates lower severity of ASD symptoms and a higher score correlates with more severe symptoms of ASD.|up to three years, assessed at 3 months intervals|The framework for evaluation of ATEC score changes over time was explained in Mahapatra et al. Autism Dev Disord, 2018. In short, changes in the score were modeled by applying the Linear Model with repeated measures. Least squares means differences generated by the model are reported below. Participants were matched using propensity score analysis.|||units on a scale||95% Confidence Interval|Mean
2557516|NCT02708277|Secondary|Number of Participants With Reformation of Intrauterine Adhesions in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group||Within the first 3 months after surgery||||participants|||Number
2557517|NCT02708277|Secondary|Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound||Within the first 3 months after surgery||||mm||Standard Deviation|Mean
2557518|NCT02708277|Secondary|Menstruation Pattern(Improvement or No Significant Change) of All Participants|Comparing with preoperative and postoperative menstrual duration, numbers of sanitary napkin using and wet area ratio of sanitary napkin to judgment whether menstrual quantity is improvement in patients|Within the first 3 months after surgery||||participants|||Number
2557519|NCT02708277|Primary|Number of Participants With Pregnancy in Loop-shaped Intrauterine Device Group and Intrauterine Balloon Group||three years||||participants|||Number
2557520|NCT02708238|Secondary|Number of Responders|Number of responders defined as the number of patients who experienced a decrease in the daily average crying time of 50% from baseline|28 days of treatment||||number of responders|||Number
2557521|NCT02708238|Primary|Median Daily Crying Time at the End of the Treatment|Median daily crying at the end of treatment (day 28).|28 days of treatment||||minutes||Full Range|Median
2557522|NCT02708212|Secondary|Overall Duration of BDE Examinations|The overall duration of both EGD and colonoscopy examinations was recorded and compared.|On the day of bidirectional endoscopy||||minutes||Standard Deviation|Mean
2557523|NCT02708212|Primary|Sedative Doses of Midazolam|During bidirectional endoscopy, the total doses of midazolam were recorded and compared between the two study groups.|On the day of bidirectional endoscopy procedures||||mg/kg||Standard Deviation|Mean
2557524|NCT02708212|Primary|Sedative Doses of Fentanyl|During bidirectional endoscopy, the total doses of fentanyl were recorded and compared between the two study groups.|On the day of endoscopic procedures.||||mcg/kg||Standard Deviation|Mean
2557525|NCT02708121|Other Pre-specified|Number of Participants Who Initiated Treatment Based on Program-provided Data and Self-report|Number of participants who initiate evidence-based weight loss treatment. Initiation is defined as completing at least one session (either group in-person session, one-on-one)|6 months|Six participants withdrew prior to learning randomization condition and were not followed.|||Participants|||Count of Participants
2557526|NCT02708121|Secondary|Intervention Acceptability (Acceptability Outcome)|Ratings on series of items developed by study team to assess patient perception of acceptability of the intervention. Items were created by study team. Possible range of 1 (strongly disagree) to 5 (strongly agree). Higher score reflects greater acceptability except for item 11.|1 month|Among mobilization tool participants, 28 patients progressed past the tool’s introductory page, and 27 patients completed the tool. The post-tool acceptability survey was completed by 20 participants (72% of those who began the tool).|||score on a item||Standard Deviation|Mean
2557527|NCT02708121|Primary|Number of Participants Attending 6 Month Follow-up Appointment|Count of enrolled participants who attend 6 month follow-up appointment|6 months||||Participants|||Count of Participants
2557528|NCT02708095|Secondary|Population Pharmacokinetics (PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss)|Plasma samples for pharmacokinetic (PK) analysis were obtained in week 0, week 4, week 8, week 16 and 24. Cmax takes all time points post dose into account and one value is reported.|Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose|All randomized participants who received at least one dose of study drug and had evaluable PK (pharmacokinetics) data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2557529|NCT02708095|Secondary|Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss)|Plasma samples for pharmacokinetic (PK) analysis were obtained in week 0, week 4, week 8, week 16 and 24. AUC takes all time points post dose into account and one value is reported.|Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose|All randomized participants who received at least one dose of study drug and had evaluable PK (pharmacokinetics) data.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2557530|NCT02708095|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity|"The Patient's Global Assessment of Disease Activity is a single-item, patient reported scale developed for the assessment of the patient's overall rating of their disease activity due to SLE. The scale measures disease activity through a 5 point Likert scale ranging from 0 (No disease activity) to 4 (Severe disease activity) at its worst over the past 7 days. LS mean was determined by MMRM model with baseline of response, region, baseline disease activity (SLEDAI-2K <10, >=10), baseline anti-dsDNA status (positive, negative), treatment, time, treatment*time (type III sum of squares)."|Baseline, Week 24|All randomized participants who received at least 1 dose of study drug with baseline and post-baseline values at the specified time point for Patient's Global Assessment of Disease Activity.|||Units on a scale||Standard Error|Least Squares Mean
2557531|NCT02708095|Secondary|Change From Baseline in SLEDAI-2K Score|SLE Disease Activity Index 2000 (SLEDAI-2K) score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, region, baseline disease activity (SLEDAI-2K <10, >=10), baseline anti-dsDNA status (positive, negative), treatment, time, treatment*time (type III sum of squares).|Baseline, Week 24|All randomized participants who received at least 1 dose of study drug with baseline and post-baseline values at the specified time point for SLEDAI-2K.|||Units on a scale||Standard Error|Least Squares Mean
2557532|NCT02708095|Secondary|Percentage of Participants Who Achieve SLE Responder Index 4 (SRI-4) Response|SRI-4 response is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores; and 3) no worsening (defined as an increase of ≥0.3 points [10 mm] from baseline) in Physician's Global Assessment of Disease Activity. The SRI-4 is a composite index used to assess disease activity in SLE. SLEDAI-2K assessment consists of 24 items with total score of 0 to 105, with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe).|Week 24|All randomized participants who received at least 1 dose of study drug with baseline and post-baseline values at the specified time point for SRI-4 response.|||Percentage of Participants|||Number
2557533|NCT02708095|Primary|Percentage of Participants Who Achieve Remission of Arthritis and/or Rash Defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)|Participants were defined as responder as follows using SLEDAI-2K definitions of arthritis and rash. If only arthritis is present at baseline, then arthritis must be absent at Week 24 to meet the primary endpoint. If only rash is present at baseline, then rash must be absent at Week 24 to meet the primary endpoint. If both arthritis and rash are present at baseline, then the primary endpoint is met if either arthritis, or rash, or both arthritis and rash are absent at Week 24.|Week 24|All randomized participants who received at least 1 dose of study drug with baseline and post-baseline values at the specified time point for remission of arthritis and/or rash.|||Percentage of Participants|||Number
2557534|NCT02707991|Secondary|Time to Hepatitis C Treatment Initiation|Number of days from study enrollment to receipt of the first dose of hepatitis C treatment|6 months|ll eligible participants who were randomized are included. Two participants were excluded (one in each arm) because they were found to be ineligible for study participation after they were randomized.|||days||Standard Deviation|Mean
2557535|NCT02707991|Primary|Number of Participants Linked to Care|"This will be assessed based on the number of participants who attend an appointment at the Viral Hepatitis Clinic within 60 days of enrolling in the study. A participant is considered linked to care if he/she attends an appointment at the clinic. A participant is considered not linked to care if he/she does not attend an appointment at the clinic. Whether a participant linked to care will be determined by looking at the medical record, where all attended appointments are documented. If no attended appointment is documented, this will be considered non-attendance/not linked to care."|60 days|All eligible participants who were randomized are included. Two participants were excluded (one in each arm) because they were found to be ineligible for study participation after they were randomized.|||Participants|||Count of Participants
2557536|NCT02707965|Secondary|Number of Seizures Reported|Number of seizures reported in all groups|Through the approximately 2 week period when the treatment is given.||||Number of Seizures|||Number
2557538|NCT02707965|Primary|Mean Cmin_ss (Test vs. Reference)|Average minimum drug plasma concentration (Cmin);|For all study drugs, time points are: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hr postdose. For twice-a-day regimen, additional points are:8, 10, and 12 hr postdose. For once-a-day drugs, additional times are:8, 10, 12, 16, and 24 hr postdose.||||microg/mL||Standard Deviation|Mean
2557539|NCT02707965|Primary|Mean Cmax_ss (Test vs. Reference)|Average maximum drug plasma concentration;|For all study drugs, time points are: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hr postdose. For twice-a-day regimen, additional points are:8, 10, and 12 hr postdose. For once-a-day drugs, additional times are:8, 10, 12, 16, and 24 hr postdose.||||microg/mL||Standard Deviation|Mean
2557540|NCT02707965|Primary|Mean AUC0-last_ss (Test vs. Reference)|Average AUC (area under the drug plasma curve.|For all study drugs, time points are: predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, and 6 hr postdose. For twice-a-day regimen, additional points are:8, 10, and 12 hr postdose. For once-a-day drugs, additional times are:8, 10, 12, 16, and 24 hr postdose.||||micro/mL/hr||Standard Deviation|Mean
2557541|NCT02707952|Secondary|Percentage of Participants With Post-Treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels < LLOQ at the end of treatment, excluding participants who were been shown to be re-infected. The confidence interval was calculated using the Wilson score method.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug (ITT population) with at least one post-treatment HCV RNA value, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
2557542|NCT02707952|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. 95% CI was calculated using the Wilson score method.|Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
2557543|NCT02707952|Secondary|Percentage of Participants for Each Sub-Population in Arms C and D With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Subpopulations defined as Genotype 1 and 2 infected cirrhotic participants, prior direct acting antiviral agent (DAA) treatment experienced (T-exp) participants, Genotype 3, 4, 5 or 6-infected participants, and participants with severe renal impairment (RI). 95% CI was calculated using the Wilson score method.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2557544|NCT02707952|Secondary|Percentage of Participants in Arm A With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. 95% CI was calculated using the normal approximation to the binomial distribution.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2557545|NCT02707952|Primary|Percentage of Participants in Arms A and B With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug, excluding participants with the Y93H polymorphism in NS5A at baseline (ITT-PS population); participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants|||Number
2557546|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Adverse Events That Led to Dose Reduction or Temporary Discontinuation of Study Treatment||Until 28 days from last dose of study treatment (Week 28)|mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo).|||percentage of participants|||Number
2557547|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Deaths of All Causes||Until 28 days from last dose of study treatment (Week 28)|mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo).|||percentage of participants|||Number
2557548|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Permanent Discontinuation of Study Treatment||Until 28 days from last dose of study treatment (Week 28)|mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo).|||percentage of participants|||Number
2557549|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)|A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect.|Until 28 days from last dose of study treatment (Week 28)|mITT population included who received at least 1 dose of double-blind study medication (NAC or placebo).|||percentage of participants|||Number
2557550|NCT02707640|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a participant who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.|Until 28 days from last dose of study treatment (Week 28)|mITT Population included participants who received at least 1 dose of double-blind study medication (NAC or placebo).|||percentage of participants|||Number
2562101|NCT02641561|Secondary|The Number of Participants With Multiple Organ Failure (MOF) After ERCP as Assessed by Elevated Creatinine Blood Test|creatinine > 1.5 milligrams/deciliter (mg/dL)|30 days after ERCP||||Participants|||Count of Participants
2557551|NCT02707640|Primary|Percentage of Participants With Early Treatment Discontinuations|Percentage of participants with early treatment discontinuations in N-Acetylcysteine and placebo cohorts during the 24-week treatment period.|From baseline up to 24 weeks|mITT population included participants who received at least 1 dose of double-blind study medication (NAC or placebo).|||percentage of participants|||Number
2557552|NCT02707640|Primary|Percentage of Participants With Dose Reductions|Percentage of participants with dose reductions in N-Acetylcysteine and placebo cohorts during the 24-week treatment period.|From baseline up to 24 weeks|mITT population included participants who received at least 1 dose of double-blind study medication (NAC or placebo).|||percentage of participants|||Number
2557553|NCT02707601|Secondary|Percentage of Participants Experiencing Grades 1 Through 4 Adverse Events After Switch to E/C/F/TAF or F/R/TAF Throughout the Study and During Coadministeration With LDV/SOF Treatment||Up to 32 weeks plus 30 days|"Safety Analysis Set (Whole Study): participants who were randomized into the study and received at least 1 dose of study drug (E/C/F/TAF, F/R/TAF, or LDV/SOF).~Safety Analysis Set (Part 2): participants who entered Part 2 of the study and received at least one dose of study drug LDV/SOF."|||percentage of participants|||Number
2557554|NCT02707601|Secondary|Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL (Virologic Failure) 24 Weeks After Start of the F/TAF-Based Regimen Using Modified FDA Snapshot Algorithm|The percentage of participants with HIV-1 RNA ≥ 50 copies/mL 24 weeks after start of the F/TAF-based regimen were analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|24 weeks after start of HIV treatment|HIV Full Analysis Set: participants who were randomized into the study and received at least 1 dose of HIV study drug, E/C/F/TAF or F/R/TAF.|||percentage of participants|||Number
2557555|NCT02707601|Secondary|Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping LDV/SOF treatment.|HCV Posttreatment Week 4|HCV Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2557556|NCT02707601|Primary|Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12)|Sustained Virologic Response (SVR12) was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping LDV/SOF treatment.|HCV Posttreatment Week 12|HCV Full Analysis Set: participants who were randomized into the study and received at least 1 dose of HCV study drug, LDV/SOF.|||percentage of participants||95% Confidence Interval|Number
2557557|NCT02707432|Secondary|Change in Diastolic Blood Pressure|As measured in mmHg|Baseline, Month 6|Data reported only for participants with both Baseline and Month 6 data.|||mmHg||Standard Deviation|Mean
2557558|NCT02707432|Secondary|Change in Systolic Blood Pressure|Blood pressure as measured in mmHg|Baseline, Month 6|Data reported only for participants with both Baseline and Month 6 data.|||mmHg||Standard Deviation|Mean
2557559|NCT02707432|Primary|Change in Weight|Measured in pounds|Baseline and 6 months after initiated treatment|Data reported only for participants with both Baseline and Month 6 data.|||pounds||Standard Deviation|Mean
2557560|NCT02707172|Primary|Amount of Diethylhexyl Phthalate Removed From Hand|Water rinse were performed immediately after hand-washing, and the concentration of diethylhexyl phthalate in the soiled water is measured.|immediately right after hand-washing|Each participant underwent two sets of experiments, one with placebo and one with intervention. 14 participants received placebo first and were crossed-over to received intervention. The other 14 participants received intervention first and were crossed-over to received placebo.|||percentage of DEHP removed||Standard Deviation|Mean
2557561|NCT02707146|Secondary|Patient-reported Outcomes|Telephone survey will be conducted within 1 week of visit using validated questionnaire items that assess patient-provider communication and patient satisfaction with care|Within 1 week of primary care study visit||||Participants|||Count of Participants
2557562|NCT02707146|Primary|Aggregate Measure of Guideline-Based Clinical Care Gaps|All patients enrolled in the study will have one or more guideline-based care gaps at baseline. Care gaps are defined as: overdue for cancer screening (mammography, colorectal cancer), overdue for chronic disease monitoring (blood pressure, HbA1c), above goal for chronic disease (SBP > 140, HbA1c > 8%), or medication related (not prescribed a statin if clinically indicated, not prescribed medicine for osteoporosis if indicated, < 80% adherence to medication for diabetes, hypertension, or hyperlipidemia), or current smoker. The investigators will assess % of patients resolving baseline clinical care gaps after 12 months. The aggregate outcome will be defined as yes/no resolution of baseline care gap. The study arms will be compared using an aggregate measure of these guideline-based clinical care gaps.|12 months||||Participants|||Count of Participants
2557563|NCT02706951|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 14|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:~≥ 70% improvement in 68-tender joint count;~≥ 70% improvement in 66-swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and week 14|Full analysis set; participants who prematurely discontinued from study drug prior to Week 14 or for whom ACR data were missing at Week 14 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2557564|NCT02706951|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 14|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:~≥ 50% improvement in 68-tender joint count;~≥ 50% improvement in 66-swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and week 14|Full analysis set; participants who prematurely discontinued from study drug prior to Week 14 or for whom ACR data were missing at Week 14 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2560841|NCT02658877|Secondary|The Effect of Omalizumab on Changes sHBEC Targets (Gene Expression Array) Compared Using Two-group T-test if Data||16 Weeks of Treatment of omalizumab or placebo|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2557565|NCT02706951|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 14|Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days. A negative change from Baseline indicates improvement.|Baseline to week 14|Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 14 was used.|||minutes||95% Confidence Interval|Least Squares Mean
2557566|NCT02706951|Secondary|Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 14|"The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.~A DAS28 score less than 2.6 indicates clinical remission."|Week 14|Full analysis set; participants who prematurely discontinued from study drug prior to Week 14 or for whom DAS28 data were missing at Week 14 were considered non-responders|||percentage of participants||95% Confidence Interval|Number
2557567|NCT02706951|Secondary|Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 14|"The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).~The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement."|Baseline to week 14|Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 14 was used.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2557568|NCT02706951|Secondary|Change From Baseline in Heath Assessment Questionnaire and Disability Index (HAQ-DI) at Week 14|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.|Baseline to week 14|Full analysis set participants with available data at baseline; multiple imputation was used for missing data.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2557569|NCT02706951|Secondary|Change From Baseline in in Disease Activity Score 28 (CRP) at Week 14|The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline in DAS28 (CRP) indicates improvement in disease activity.|Baseline to week 14|Full analysis set participants with available data at baseline; multiple imputation was used for missing post-baseline data.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2557570|NCT02706951|Primary|Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 14|"The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was low disease activity, based on a Disease Activity Score 28 (DAS28)-CRP score of ≤ 3.2 at Week 14.~The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.~A DAS28 score less than or equal to 3.2 indicates low disease activity."|Week 14|Full analysis set; participants who prematurely discontinued from study drug prior to Week 14 or for whom DAS28 data were missing at Week 14 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2557571|NCT02706951|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14|"The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) at Week 14. Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:~≥ 20% improvement in 68-tender joint count;~≥ 20% improvement in 66-swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and week 14|Full analysis set; participants who prematurely discontinued from study drug prior to Week 14 or for whom ACR data were missing at Week 14 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2557572|NCT02706938|Secondary|Patient Preference|Percentage of patients who preferred head of bed elevation after trial ending|Secondary outcome will be assessed 14 weeks after starting the trial|All participants who used both head of bed elevation and control interventions, regardless they did not complete the entire trial or did not retrieve all the questionnaires, were asked for their preference between head of bed elevation or control intervention.|||percent of participants||95% Confidence Interval|Number
2557573|NCT02706938|Secondary|Change in Quality of Life as Assessed by Short Form 36 Questionnaire, Administered at Baseline and 6 Weeks After Each Intervention|Change in Short Form 36 Scores administered at baseline and 6 weeks after each intervention. Range from 0 to 100, with a higher punctuation meaning a better outcome. Quality of life change of ≥ 10 points from baseline was considered clinically relevant.|Secondary outcome will be assessed at baseline and 6 weeks after starting each period|Patients who received the intervention head of bed elevation were grouped, regardless of the arm of the study they came from. Likewise, all participants of any arm who received control intervention were grouped. For crossover reasons, only 39 patients who completed both interventions were analyzed, and 1 patient was excluded because of missing data|||scores on a scale||Standard Deviation|Mean
2557574|NCT02706938|Primary|Change in Reflux Disease Questionnaire Scores Administered at Baseline and 6 Weeks After Each Intervention|Change in Reflux Disease Questionnaire Scores administered at baseline and 6 weeks after each intervention. Range from 0 to 6, with a higher punctuation meaning a worse outcome. Symptom change of ≥ 0,6 points from baseline was considered clinically relevant.|Primary outcome will be assessed at baseline and 6 weeks after starting each period|All patients who received the intervention head of bed elevation were grouped, regardless of the arm of the study they came from. Likewise, all participants of any arm who received control intervention were grouped. Only 39 patients who completed both interventions were analyzed because of the crossover nature of this clinical trial.|||scores on a scale||Standard Deviation|Mean
2557575|NCT02706925|Secondary|Cmax (Maximum Measured Concentration of the Analyte in Plasma)|"This outcome measure presents maximum concentration of analyte in plasma (Cmax).~Time frame note: The time points 72:00h, 96:00h below was only applicable for highest dose (and corresponding placebo subjects).~Two blood sample for stability testing were taken at 3:00h time point from the Treatment C dose group only.~The doses ranged from 10 μg to 3600 μg for the outcome measure [Cmax (maximum measured concentration of the analyte in plasma)]."|1.30 (hours: minutes) hours (h) before drug administration and 0:05h, 0:10h, 0:15h, 0:20h, 0:30h, 0:40h, 0:50h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h, 96:00h after drug administration.|Pharmacokinetic Analysis Set (PKS): This subject set includes all subjects from the TS on who received BI 443651 and who provided at least 1 PK endpoint value that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2557576|NCT02706925|Secondary|AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)|"This outcome measure presents area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz).~Time frame note: The time points 72:00h, 96:00h below was only applicable for highest dose (and corresponding placebo subjects).~Two blood sample for stability testing were taken at 3:00h time point from the Treatment C dose group only.~The doses ranged from 10 μg to 3600 μg for the outcome measure [AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)]."|1.30 (hours: minutes) hours (h) before drug administration and 0:05h, 0:10h, 0:15h, 0:20h, 0:30h, 0:40h, 0:50h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h, 72:00h, 96:00h after drug administration.|Pharmacokinetic Analysis Set (PKS): This subject set includes all subjects from the TS on who received Boehringer Ingelheim (BI) 443651 and who provided at least 1 PK endpoint value that was judged as PK evaluable and not affected by protocol violations relevant to the evaluation of PK parameters.|||pmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2557577|NCT02706925|Primary|Percentage of Subjects With Drug-related Adverse Events (AEs)|This outcome measure presents percentage of the subjects with drug-related AEs. The doses ranged from 10 μg to 3600 μg for the outcome measure [Percentage of subjects with drug-related Adverse Events (AEs)].|Up to 216 hours.|Treated Set (TS): This subject set includes all subjects from the Randomised Set (RS) who were documented to have taken at least 1 dose of study drug.|||Percentage of subjects|||Number
2557578|NCT02706899|Secondary|Overall Survival (OS)|Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first dose of study medication to death due to any cause.|N/A - End point not assessed|No patients were assessed for this outcomes as the study did not progress to Phase 2.||||||
2557579|NCT02706899|Secondary|Rate of Transformation to Acute Myeloid Leukemia (AML)|Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the rate of transformation to AML after initiation of study therapy.|N/A - End point not assessed|No patients were assessed for this outcomes as the study did not progress to Phase 2.||||||
2557580|NCT02706899|Secondary|Progression Free Survival (PFS)|Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first dose of study medication to first documentation of disease progression/relapse, or to death due to any cause, whichever occurs first.|N/A - End point not assessed|No patients were assessed for this outcomes as the study did not progress to Phase 2.||||||
2557581|NCT02706899|Secondary|Duration of Response (DOR) Rate|Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the time from first observation of response (CR, PR, or Marrow CR) to disease progression/relapse or death from any cause, whichever occurs first.|N/A - End point not assessed|No patients were assessed for this outcomes as the study did not progress to Phase 2.||||||
2557582|NCT02706899|Secondary|Hematologic Improvement (HI) Rate|Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the HI rate, as defined by the 2006 IWG criteria for MDS.|N/A - End point not assessed|No patients were assessed for this outcomes as the study did not progress to Phase 2.||||||
2557583|NCT02706899|Secondary|Complete Response Rate (CR)|Study did not progress to Phase 2. A comparison between the 2 arms (Phase 2) of the CR rate, as defined by the 2006 IWG criteria for MDS.|N/A - End point not assessed|No patients were assessed for this outcomes as the study did not progress to Phase 2.||||||
2557584|NCT02706899|Secondary|Safety of the Combination of Vadastuximab Talirine and Azacitidine Measured by the Number of Participants With Adverse Events and Laboratory Abnormalities|As defined by the number of participants with adverse events and laboratory abnormalities. Participants are included only once per row, even if the participant experienced multiple events applicable to the category.|Up to 1 year||||Participants|||Count of Participants
2557585|NCT02706899|Primary|Phase 2 Outcome Measure: Overall Response Rate for the Phase 2 Portion of the Study||N/A - End point not assessed|No patients were assessed for this outcomes as the study did not progress to Phase 2.||||||
2557586|NCT02706899|Primary|Phase 1 Outcome Measure: Recommended Dose of Vadastuximab Talirine for the Phase 2 Portion of the Study|A recommended dose of vadastuximab talirine was not identified in Phase 1 due to study termination. Number of dose delays and reductions are reported in lieu of a dose recommendation.|Up to 1 year||||Number of doses|||Number
2557697|NCT02705807|Primary|Change From Baseline in Heart Rate|Heart rate was measured at Baseline, 1 hr, 3 hr, 24 hr, Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline'). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Baseline and up to Week 4|ITT population|||Beats per minute (bpm)||Standard Deviation|Mean
2557587|NCT02706886|Secondary|Percentage Change From Baseline of Creatinine Clearance Corrected for BSA in Part B||Part B (MAD): Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449|PD Analysis Set in Part B consisted of all patients with PH1 who received at least 1 dose of study drug (lumasiran, placebo) and had at least 1 postdose blood and/or urine sample available that was evaluable for PD assessments.|||percentage change from baseline||Standard Deviation|Mean
2557588|NCT02706886|Secondary|Baseline Creatinine Clearance Corrected for BSA in Part B||Part B (MAD): Baseline|PD Analysis Set in Part B consisted of all patients with PH1 who received at least 1 dose of study drug (lumasiran, placebo) and had at least 1 postdose blood and/or urine sample available that was evaluable for PD assessments.|||mL/min/1.73 m^2||Standard Deviation|Mean
2557589|NCT02706886|Secondary|Percentage Change From Baseline of 24 Hour Urine Glycolate:Creatinine Ratio in Part B - Initial 85 Days|The endpoint was only measured during the initial 85 days in Part B.|Part B (MAD): 24 hour urine collections on Days 29, 57 and 85|PD Analysis Set in Part B consisted of all patients with PH1 who received at least 1 dose of study drug (lumasiran, placebo) and had at least 1 postdose blood and/or urine sample available that was evaluable for PD assessments.|||percentage change from baseline||Standard Deviation|Mean
2557590|NCT02706886|Secondary|Baseline 24 Hour Urine Glycolate:Creatinine Ratio in Part B - Initial 85 Days|The endpoint was only measured during the initial 85 days in Part B.|Part B (MAD): Baseline|PD Analysis Set in Part B consisted of all patients with PH1 who received at least 1 dose of study drug (lumasiran, placebo) and had at least 1 postdose blood and/or urine sample available that was evaluable for PD assessments.|||mg/g||Standard Deviation|Mean
2557591|NCT02706886|Secondary|Percentage Change From Baseline of 24 Hour Urine Oxalate Corrected for BSA in Part B|The endpoint was only measured in Part B.|Part B (MAD): 24 hour urine collections on Days 29, 57, 85, 113, 141, 169, 197|PD Analysis Set in Part B consisted of all patients with PH1 who received at least 1 dose of study drug (lumasiran, placebo) and had at least 1 postdose blood and/or urine sample available that was evaluable for PD assessments.|||percentage change from baseline||Standard Deviation|Mean
2557592|NCT02706886|Secondary|Baseline of 24 Hour Urine Oxalate Corrected for BSA in Part B|The endpoint was only measured in Part B.|Part B (MAD): Baseline|PD Analysis Set in Part B consisted of all patients with PH1 who received at least 1 dose of study drug (lumasiran, placebo) and had at least 1 postdose blood and/or urine sample available that was evaluable for PD assessments.|||mmol/24h/1.73m^2||Standard Deviation|Mean
2557593|NCT02706886|Secondary|Percentage Change From Baseline in Spot Urine Glycolate:Creatinine Ratio in Part A|The endpoint was only measured in Part A.|Part A (SAD): Days 29 and 57|PD Analysis Set in Part A consisted of all healthy participants who received at least 1 dose of study drug (lumasiran, placebo) and had at least 1 postdose blood and/or urine sample available that was evaluable for PD assessments.|||percentage change from baseline||Standard Deviation|Mean
2557594|NCT02706886|Secondary|Baseline Spot Urine Glycolate:Creatinine Ratio in Part A|The endpoint was only measured in Part A.|Part A (SAD): Baseline|PD Analysis Set for Part A consisted of all healthy participants who received at least 1 dose of study drug (lumasiran, placebo) and had at least 1 postdose blood and/or urine sample available that was evaluable for PD assessments.|||mg/g||Standard Deviation|Mean
2557595|NCT02706886|Secondary|Percentage Change From Baseline in Plasma Glycolate Concentration|The PD outcome measure of plasma glycolate concentration could only be calculated for Part A. Due to an issue with the plasma glycolate assay at the testing laboratory the data for Part B could not be calculated.|Part A (SAD): Days 15, 29, 57 and 85; Part B (MAD): Days 15, 29, 57, 85|PD Analysis Set consisted of all participants who received at least 1 dose of study drug (lumasiran, placebo) and had at least 1 postdose blood sample available that was evaluable for PD assessments. Due to an issue with plasma glycolate assay at the testing laboratory the data for Part B could not be calculated.|||percentage change from baseline||Standard Deviation|Mean
2557596|NCT02706886|Secondary|Baseline Plasma Glycolate Concentration|The pharmacodynamic (PD) outcome measure of plasma glycolate concentration could only be calculated for Part A. Due to an issue with the plasma glycolate assay at the testing laboratory the data for Part B could not be calculated.|Part A (SAD): Baseline, Part B (MAD): Baseline|PD Analysis Set consisted of all participants who received at least 1 dose of study drug (lumasiran, placebo) and had at least 1 postdose blood sample available that was evaluable for PD assessments. Due to an issue with plasma glycolate assay at the testing laboratory the data for Part B could not be calculated.|||umol/L||Standard Deviation|Mean
2557597|NCT02706886|Secondary|Renal Clearance (CLR) of Lumasiran|Samples for Part A were collected only on Day 1; Part B on Days 1 and 57 for qM and on Days 1 and 85 for q3M arm groups.|Part A (SAD): Day 1: pooled urine 0-4 h, 4-8 h and 8-24 h; Part B (MAD): Part B (MAD phase): Days 1 and 57 for qM dosing and Days 1 and 85 for q3M dosing: pooled urine 0-4 h, 4-8 h, 8-12 h and 12-24 h|PK Analysis Set consisted of all healthy participants and patients who received at least 1 dose of lumasiran and had at least 1 postdose sample for PK parameters and who had evaluable PK data.|||L/h||Standard Deviation|Mean
2557598|NCT02706886|Secondary|Fraction Excreted in Urine in 24 Hours (Fe0-24) of Lumasiran|Samples for Part A were collected only on Day 1; Part B on Days 1 and 57 for qM and on Days 1 and 85 for q3M arm groups.|Part A (SAD): Day 1: pooled urine 0-4 h, 4-8 h and 8-24 h; Part B (MAD): Part B (MAD phase): Days 1 and 57 for qM dosing and Days 1 and 85 for q3M dosing: pooled urine 0-4 h, 4-8 h, 8-12 h and 12-24 h|PK Analysis Set consisted of all healthy participants and patients who received at least 1 dose of lumasiran and had at least 1 postdose sample for PK parameters and who had evaluable PK data.|||percentage fractional excretion||Standard Deviation|Mean
2557599|NCT02706886|Secondary|Terminal Half-life (t1/2) of Lumasiran in Plasma|Samples for Part A were collected only on Day 1; Part B on Days 1 and 57 for qM and on Days 1 and 85 for q3M arm groups.|Part A (SAD): Day 1: predose, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h; Part B (MAD): Days 1 and 57 for qM dosing and Days 1 and 85 for q3M dosing: predose, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h and 48 h|PK Analysis Set consisted of all healthy participants and patients who received at least 1 dose of lumasiran and had at least 1 postdose sample for PK parameters and who had evaluable PK data.|||hours||Standard Deviation|Mean
2557737|NCT02704689|Secondary|Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as Measured by the SF-12.|Patient Reported Outcomes: Evaluations of Quality of Life (QOL) as measured by the SF-12.|24 months|The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.||||||
2557600|NCT02706886|Secondary|Area Under the Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUC0-last) of Lumasiran in Plasma|Samples for Part A were collected only on Day 1; Part B on Days 1 and 57 for qM and on Days 1 and 85 for q3M arm groups.|Part A (SAD): Day 1: predose, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h; Part B (MAD): Days 1 and 57 for qM dosing and Days 1 and 85 for q3M dosing: predose, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h and 48 h|PK Analysis Set consisted of all healthy participants and patients who received at least 1 dose of lumasiran and had at least 1 postdose sample for PK parameters and who had evaluable PK data.|||h*ng/mL||Standard Deviation|Mean
2557601|NCT02706886|Secondary|Time to Cmax (Tmax) of Lumasiran in Plasma|Samples for Part A were collected only on Day 1; Part B on Days 1 and 57 for qM and on Days 1 and 85 for q3M arm groups.|Part A (SAD): Day 1: predose, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h and 24 h; Part B (MAD): Days 1 and 57 for qM dosing and Days 1 and 85 for q3M dosing: predose, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h and 48 h|PK Analysis Set consisted of all healthy participants and patients who received at least 1 dose of lumasiran and had at least 1 postdose sample for PK parameters and who had evaluable PK data.|||hours||Full Range|Median
2557602|NCT02706886|Secondary|Maximum Concentration (Cmax) of Lumasiran in Plasma|Samples for Part A were collected only on Day 1; Part B on Days 1 and 57 for qM and on Days 1 and 85 for q3M arm groups.|Part A (SAD): Day 1: predose, 30 minutes (min), 1 hour (h), 2 h, 4 h, 6 h, 8 h and 24 h; Part B (MAD): Days 1 and 57 for qM dosing and Days 1 and 85 for q3M dosing: predose, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h and 48 h|Pharmacokinetic (PK) Analysis Set consisted of all healthy participants and patients who received at least 1 dose of lumasiran and had at least 1 postdose sample for PK parameters and who had evaluable PK data.|||ng/mL||Standard Deviation|Mean
2557603|NCT02706886|Primary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.|Part A (SAD): Up to 405 days; Part B (MAD): Up to 546 days|Safety Analysis Set consisted of all healthy participants and patients, who received at least 1 dose of study drug (lumasiran, placebo), grouped according to actual treatment received. Part B participants who crossed over from placebo to the lumasiran arms are included in the placebo arm as well as lumasiran arms.|||Participants|||Count of Participants
2557604|NCT02706873|Secondary|Percentage of Participants With No Radiographic Progression at Week 24 - Japan Sub-study|"No radiographic progression is defined as a change from Baseline in mTSS ≤ 0. The mTSS measures the level of joint damage from radiographs of the hands and feet, which were assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score. Joint erosion severity was assessed in 16 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).~Joint space narrowing (JSN) was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).~The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst)."|Week 24|"Full analysis set participants with available data at Baseline; linear extrapolation was used for participants who discontinued prior to Week 24 or for whom x-ray data were missing at Week 24.~The Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups."|||percentage of participants||95% Confidence Interval|Number
2557605|NCT02706873|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 - Japan Sub-study|"The mTSS measures the level of joint damage from radiographs of the hands and feet, assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score.~Joint erosion was assessed in 16 joints in each hand/wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).~JSN was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).~The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst). A change from Baseline greater than 0 indicates progression."|Baseline to Week 24|"Full analysis set participants with available data at Baseline; linear extrapolation was used for participants who discontinued prior to Week 24 or for whom x-ray data were missing at Week 24.~The Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups."|||units on a scale||95% Confidence Interval|Least Squares Mean
2557606|NCT02706873|Secondary|Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 24 - Japan Sub-study|"The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.~A DAS28 score less than 2.6 indicates clinical remission."|Week 24|"Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders.~The Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups."|||percentage of participants||95% Confidence Interval|Number
2557607|NCT02706873|Secondary|Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 - Japan Sub-study|"The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.~A DAS28(CRP) score less than or equal to 3.2 indicates low disease activity."|Week 12|"Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders.~The Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups."|||percentage of participants||95% Confidence Interval|Number
2557608|NCT02706873|Secondary|Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 - Japan Sub-study|"The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).~The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement."|Baseline to Week 12|"Full analysis set participants with available data at baseline; multiple imputation was used for missing data.~The Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups."|||scores on a scale||95% Confidence Interval|Least Squares Mean
2557609|NCT02706873|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 - Japan Sub-study|"The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.~A negative change from Baseline in the overall score indicates improvement."|Baseline to week 12|"Full analysis set participants with available data at baseline; multiple imputation was used for missing data.~The Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups."|||scores on a scale||95% Confidence Interval|Least Squares Mean
2557610|NCT02706873|Secondary|Change From Baseline in DAS28 (CRP) at Week 12 - Japan Sub-study|The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.|Baseline to Week 12|"Full analysis set participants with available data at Baseline; multiple imputation was used for missing post-baseline data.~The Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups."|||scores on a scale||95% Confidence Interval|Least Squares Mean
2557611|NCT02706873|Secondary|Percentage of Participants With an ACR70 Response at Week 12 - Japan Sub-study|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:~≥ 70% improvement in 68-tender joint count;~≥ 70% improvement in 66-swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 12|"Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.~The Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups."|||percentage of participants||95% Confidence Interval|Number
2557612|NCT02706873|Secondary|Percentage of Participants With an ACR50 Response at Week 12 - Japan Sub-study|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:~≥ 50% improvement in 68-tender joint count;~≥ 50% improvement in 66-swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 12|"Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.~The Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups."|||percentage of participants||95% Confidence Interval|Number
2557613|NCT02706873|Secondary|Percentage of Participants With an ACR20 Response at Week 12 - Japan Sub-study|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:~≥ 20% improvement in 68-tender joint count;~≥ 20% improvement in 66-swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 12|"Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.~The Japan sub-study analysis includes participants enrolled in Japan under the methotrexate and upadacitinib 7.5 mg, 15 mg, and 30 mg treatment groups."|||percentage of participants||95% Confidence Interval|Number
2557614|NCT02706873|Secondary|Percentage of Participants With an ACR70 Response at Week 24 - Global Analysis|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:~≥ 70% improvement in 68-tender joint count;~≥ 70% improvement in 66-swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 24|"Full analysis set; participants who prematurely discontinued from study drug prior to Week 24 or for whom ACR data were missing at Week 24 were considered non-responders.~The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups."|||percentage of participants||95% Confidence Interval|Number
2558606|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress: Nuclear Buds|Evidences of clinically definite oxidative stress:nuclear buds Confirmed by Cytokinesis-block Micronucleus Test|before induction,clamping removal ,operation ending,1,3,7days post surgery||||number of nuclear buds/1000 BN cells||Standard Deviation|Mean
2557615|NCT02706873|Secondary|Percentage of Participants With an ACR20 Response at Week 24 - Global Analysis|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:~≥ 20% improvement in 68-tender joint count;~≥ 20% improvement in 66-swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 24|"Full analysis set; participants who prematurely discontinued from study drug prior to Week 24 or for whom ACR data were missing at Week 24 were considered non-responders.~The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups."|||percentage of participants||95% Confidence Interval|Number
2557616|NCT02706873|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12 - Global Analysis|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:~≥ 70% improvement in 68-tender joint count;~≥ 70% improvement in 66-swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 12|"Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.~The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups."|||percentage of participants||95% Confidence Interval|Number
2557617|NCT02706873|Secondary|Percentage of Participants With No Radiographic Progression at Week 24 - Global Analysis|"No radiographic progression is defined as a change from Baseline in mTSS ≤ 0. The mTSS measures the level of joint damage from radiographs of the hands and feet, which were assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score. Joint erosion severity was assessed in 16 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).~Joint space narrowing (JSN) was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).~The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst)."|Week 24|"Full analysis set participants with available data at Baseline; linear extrapolation was used for participants who discontinued prior to Week 24 or for whom x-ray data were missing at Week 24.~The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups."|||percentage of participants||95% Confidence Interval|Number
2557618|NCT02706873|Secondary|Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 24 - Global Analysis|"The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).~The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement."|Baseline to Week 24|"Full analysis set participants with available data at baseline; multiple imputation was used for missing data.~The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups."|||scores on a scale||95% Confidence Interval|Least Squares Mean
2557619|NCT02706873|Secondary|Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 24 - Global Analysis|"The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.~A DAS28(CRP) score less than or equal to 3.2 indicates low disease activity."|Week 24|"Full analysis set; participants who prematurely discontinued from study drug prior to Week 24 or for whom DAS28 data were missing at Week 24 were considered non-responders.~The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups."|||percentage of participants||95% Confidence Interval|Number
2557620|NCT02706873|Secondary|Percentage of Participants With an ACR50 Response at Week 24 - Global Analysis|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:~≥ 50% improvement in 68-tender joint count;~≥ 50% improvement in 66-swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 24|"Full analysis set; participants who prematurely discontinued from study drug prior to Week 24 or for whom ACR data were missing at Week 24 were considered non-responders.~The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups."|||percentage of participants||95% Confidence Interval|Number
2557635|NCT02706847|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12|"The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.~A negative change from Baseline in the overall score indicates improvement."|Baseline and Week 12|Full analysis set participants with available data at baseline; multiple imputation was used for missing data.|||units on a scale||95% Confidence Interval|Least Squares Mean
2557621|NCT02706873|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24 - Global Analysis|"The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.~A negative change from Baseline in the overall score indicates improvement."|Baseline to Week 24|"Full analysis set participants with available data at baseline; multiple imputation was used for missing data.~The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups."|||scores on a scale||95% Confidence Interval|Least Squares Mean
2557622|NCT02706873|Secondary|Change From Baseline in DAS28 (CRP) at Week 24 - Global Analysis|The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.|Baseline to Week 24|"Full analysis set participants with available data at Baseline; multiple imputation was used for missing post-baseline data.~The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups."|||scores on a scale||95% Confidence Interval|Least Squares Mean
2557623|NCT02706873|Secondary|Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12 - Global Analysis|"The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).~The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement."|Baseline to week 12|"Full analysis set participants with available data at baseline; multiple imputation was used for missing data.~The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups."|||scores on a scale||95% Confidence Interval|Least Squares Mean
2557624|NCT02706873|Secondary|Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12 - Global Analysis|"The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.~A DAS28(CRP) score less than or equal to 3.2 indicates low disease activity."|Week 12|"Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders.~The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups."|||percentage of participants||95% Confidence Interval|Number
2557625|NCT02706873|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 - Global Analysis|"The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.~A negative change from Baseline in the overall score indicates improvement."|Baseline to week 12|"Full analysis set participants with available data at baseline; multiple imputation was used for missing data.~The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups."|||scores on a scale||95% Confidence Interval|Least Squares Mean
2557626|NCT02706873|Secondary|Change From Baseline in DAS28 (CRP) at Week 12 - Global Analysis|The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.|Baseline to Week 12|"Full analysis set participants with available data at Baseline; multiple imputation was used for missing post-baseline data.~The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups."|||scores on a scale||95% Confidence Interval|Least Squares Mean
2557627|NCT02706873|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 - Global Analysis|"The 2nd primary endpoint for Japan/PMDA regulatory purposes was change from baseline in mTSS at Week 24.~The mTSS measures the level of joint damage from radiographs of the hands and feet, assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score.~Joint erosion was assessed in 16 joints in each hand/wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).~JSN was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).~The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst). A change from Baseline greater than 0 indicates progression."|Baseline to Week 24|"Full analysis set participants with available data at Baseline; linear extrapolation was used for participants who discontinued prior to Week 24 or for whom x-ray data were missing at Week 24.~The global analysis population includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups."|||units on a scale||95% Confidence Interval|Least Squares Mean
2557628|NCT02706873|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 - Global Analysis|"The primary endpoint for Japan/Pharmaceuticals and Medical Devices Agency (PMDA) regulatory purposes was ACR 20% response (ACR20) at Week 12. Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:~≥ 20% improvement in 68-tender joint count;~≥ 20% improvement in 66-swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 12|"Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.~The global analysis includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups."|||percentage of participants||95% Confidence Interval|Number
2557629|NCT02706873|Primary|Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 24 - Global Analysis|"The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was clinical remission, based on a Disease Activity Score 28 (DAS28)-CRP score of < 2.6 at Week 24.~The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.~A DAS28 score less than 2.6 indicates clinical remission."|Week 24|"Full analysis set; participants who prematurely discontinued from study drug prior to Week 24 or for whom DAS28 data were missing at Week 24 were considered non-responders.~The global analysis includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups."|||percentage of participants||95% Confidence Interval|Number
2557630|NCT02706873|Primary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12 - Global Analysis|"The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 50% response (ACR50) at Week 12. Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:~≥ 50% improvement in 68-tender joint count;~≥ 50% improvement in 66-swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 12|"Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.~The global analysis includes participants enrolled under the methotrexate and upadacitinib 15 mg and 30 mg treatment groups."|||percentage of participants||95% Confidence Interval|Number
2557631|NCT02706847|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:~≥ 20% improvement in 68-tender joint count;~≥ 20% improvement in 66-swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and week 1|Full analysis set; participants who prematurely discontinued from study drug prior to Week 1 or for whom ACR data were missing at Week 1 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2557632|NCT02706847|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:~≥ 70% improvement in 68-tender joint count;~≥ 70% improvement in 66-swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 12|Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2557633|NCT02706847|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:~≥ 50% improvement in 68-tender joint count;~≥ 50% improvement in 66-swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 12|Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2557634|NCT02706847|Secondary|Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12|"The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).~The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement."|Baseline and Week 12|Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.|||units on a scale||95% Confidence Interval|Least Squares Mean
2557695|NCT02705807|Primary|Absolute Values of Oxygen Saturation|Oxygen saturation was measured by pulse oximetry at Baseline (BL), 1 hr, 3 hr, 24 hr, Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline').|Baseline and up to Week 4|ITT population|||Percentage||Standard Deviation|Mean
2557636|NCT02706847|Secondary|Change From Baseline in in Disease Activity Score 28 (CRP) at Week 12|The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline in DAS28 (CRP) indicates improvement in disease activity.|Baseline and Week 12|Full analysis set participants with available data at baseline; multiple imputation was used for missing post-baseline data.|||units on a scale||95% Confidence Interval|Least Squares Mean
2557637|NCT02706847|Primary|Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12|"The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was low disease activity, based on a Disease Activity Score 28 (DAS28)-CRP score of ≤ 3.2 at Week 12.~The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.~A DAS28 score less than or equal to 3.2 indicates low disease activity."|Week 12|Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2557638|NCT02706847|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12|"The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) at Week 12. Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:~≥ 20% improvement in 68-tender joint count;~≥ 20% improvement in 66-swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 12|Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2557639|NCT02706834|Secondary|AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-828F (Free Base of TAK-828)||Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dose|PK Set included participants who received at least 1 dose of study drug and had at least 1 measurable plasma or urine concentration of TAK-828F.Food effect statistical analysis is based on 10 participants who received TAK-828 100 mg fasted and fed.AUC∞ was not calculated for TAK-828 0.1 mg arm due to lack of well-defined terminal elimination phase.|||ng*h/mL||Standard Deviation|Mean
2557640|NCT02706834|Secondary|t1/2z: Terminal Disposition Phase Half-Life for TAK-828F (Free Base of TAK-828)||Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dose|Pharmacokinetic (PK) Set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma or urine concentration of TAK-828F. T1/2z was not calculated for the TAK-828 0.1 mg arm because Lambda z, required for the calculation, was not calculated due to the lack of a well-defined terminal elimination phase.|||h||Standard Deviation|Mean
2557641|NCT02706834|Secondary|Tmax: Time of First Occurrence of Cmax for TAK-828F (Free Base of TAK-828)||Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dose|Pharmacokinetic (PK) Set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma or urine concentration of TAK-828F.|||hours (h)||Full Range|Median
2557642|NCT02706834|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Measurements at Least Once Post-dose|Heart Rate <50 beats per minute (bpm) >120 bpm; QTcB (Bazett's Correction Formula) ≤50 milliseconds (msec) or ≥500 msec OR ≥30 msec change from Baseline and ≥450 msec; QTcF (Fridericia's Correction Formula) ≤50 msec or ≥500 msec OR ≥30 msec change from Baseline (CFB) and ≥450 msec.|Day 1 up to 7 days after last dose of study drug (up to 52 days)|Safety Set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2557643|NCT02706834|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose|"Vital signs measurements that met the following criteria were considered to be markedly abnormal:~Systolic Blood Pressure (SBP) <85 mmHg or >180 mmHg supine laying face upward) or standing; Diastolic Blood Pressure (DBP) <50 mmHg or >110 mmHg supine or standing; Pulse Rate (PR) <50 beats/minute (bpm) or >120 bpm supine or standing; Temperature <35.6 degrees Celsius (C) or >37.7 degrees C."|Day 1 up to 7 days after last dose of study drug (up to 52 days)|Safety Set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2557644|NCT02706834|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose|"Hematology and Chemistry values that met the following criteria were considered to be markedly abnormal:~Erythrocytes, Hematocrit and Hemoglobin <0.8*Lower Limit of Normal (LLN) or >1.2*Upper Limit of Normal ULN.; Leukocytes <0.5*LLN or >1.5*ULN; Platelet <75 or >600 10^9/liter (L).~Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase >3*ULN; Albumin <25 g/L; Bilirubin > 34.2 umol/L; Blood Urea Nitrogen >10.7 mmol/L; Chloride <75 or >126 mmol/L; Creatinine >177 umol/L; Direct Bilirubin >2*ULN; Glucose <2.8 or >19.4 mmol/L; Potassium <3.0 or >6.0 mmol/L; Protein <0.8*LLN or >1.2*ULN; Sodium <130 or >150 mmol/L."|Day 1 up to 7 days after last dose of study drug (up to 52 days)|Safety Set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2557645|NCT02706834|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)||Day 1 up to 30 days after last dose of study drug (up to 85 days)|Safety Set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2557646|NCT02706834|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-828F (Free Base of TAK-828)||Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dose|Pharmacokinetic (PK) Set included all participants who received at least 1 dose of study drug and had at least 1 measurable plasma or urine concentration of TAK-828F. Food effect statistical analysis is based on 10 participants who received TAK-828 100 mg under fasted and fed conditions.|||ng/mL||Standard Deviation|Mean
2557647|NCT02706834|Primary|Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 up to 30 days after last dose of study drug (up to 85 days)|Safety Set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2557648|NCT02706717|Secondary|Tolerability|Tolerability was successfully completing the protocol-defined treatment period.|Treatment dispensation to Week 38|All enrolled participants who initiated study treatment.|||Participants|||Count of Participants
2557649|NCT02706717|Secondary|Safety|"Summary of the highest adverse event grade (0-5) for each participant.~Protocol definition of Adverse Events: 1) signs and symptoms Grade ≥3 and any that led to a change in treatment regardless of grade; 2) new diagnoses; 3) Grade ≥3 lab values and any that led to a change in treatment or were associated with a diagnosis were recorded, regardless of grade.~DAIDS AE Grading Table, Version 2.0 was used."|Treatment dispensation to Week 38|All enrolled participants who initiated study treatment.|||Participants|||Count of Participants
2557650|NCT02706717|Secondary|Change in I-FABP From Week 2 to Week 26.|Absolute change was calculated as the value at Week 26 minus the value at Week 2.|Weeks 2 and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 I-FABP data were excluded.|||ng/mL||95% Confidence Interval|Mean
2557651|NCT02706717|Secondary|Change in Shannon Diversity Index From Week 26 to Week 38.|"Absolute change was calculated as the value at Week 38 minus the value at Week 26.~Shannon is a diversity index that reflects how many different quantifiable types (species, individuals, items, etc…) there are in a dataset (see Lemos and Magurran references). The Shannon index is an estimator of richness and evenness. It quantifies uncertainty (entropy) within a dataset. The Shannon Index ranges from 0-5. The greater a value is, the more diverse it is but only in direct comparison to groups considering the same parameters. That is, diversity indices are relative to the community (cohort or ecosystem) studied in part due to the definition of the types that are considered."|Weeks 26 and 38|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 26 and Week 38 Shannon diversity index data were excluded.|||Estimator of species richness & evenness||95% Confidence Interval|Mean
2557652|NCT02706717|Secondary|Change in Chao1 Richness Index From Week 26 to Week 38.|"Absolute change was calculated as the value at Week 38 minus the value at Week 26.~Chao1 is a diversity index that reflects how many different quantifiable types (species, individuals, items, etc…) there are in a dataset (see Chao reference). Chao1 diversity is a richness measure which quantifies how many different types there are in a given dataset. The Chao 1 index can range from 1 to infinity as it is constrained only by the number of types defined as measurable. The greater a value is, the more diverse it is but only in direct comparison to groups considering the same parameters. That is, diversity indices are relative to the community (cohort or ecosystem) studied in part due to the definition of the types that are considered."|Weeks 26 and 38|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 26 and Week 38 Chao1 richness index data were excluded.|||Estimator of species richness||95% Confidence Interval|Mean
2557653|NCT02706717|Secondary|Change in Shannon Diversity Index From Week 2 to Week 26.|"Absolute change was calculated as the value at Week 26 minus the value at Week 2.~Shannon is a diversity index that reflects how many different quantifiable types (species, individuals, items, etc…) there are in a dataset (see Lemos and Magurran references). The Shannon index is an estimator of richness and evenness. It quantifies uncertainty (entropy) within a dataset. The Shannon Index ranges from 0-5. The greater a value is, the more diverse it is but only in direct comparison to groups considering the same parameters. That is, diversity indices are relative to the community (cohort or ecosystem) studied in part due to the definition of the types that are considered."|Weeks 2 and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 Shannon diversity index data were excluded.|||Estimator of species richness & evenness||95% Confidence Interval|Mean
2557654|NCT02706717|Secondary|Change in Chao1 Richness Index From Week 2 to Week 26.|"Absolute change was calculated as the value at Week 26 minus the value at Week 2.~Chao1 is a diversity index that reflects how many different quantifiable types (species, individuals, items, etc…) there are in a dataset (see Chao reference). Chao1 diversity is a richness measure which quantifies how many different types there are in a given dataset. The Chao 1 index can range from 1 to infinity as it is constrained only by the number of types defined as measurable. The greater a value is, the more diverse it is but only in direct comparison to groups considering the same parameters. That is, diversity indices are relative to the community (cohort or ecosystem) studied in part due to the definition of the types that are considered."|Weeks 2 and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 Chao1 richness index data were excluded.|||Estimator of species richness||95% Confidence Interval|Mean
2557655|NCT02706717|Secondary|Change in %CD8+CD28-CD57+ From Week 2 to Week 26.|Absolute change was calculated as the value at Week 26 minus the value at Week 2.|Weeks 2 and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 %CD8+CD28-CD57+ data were excluded.|||Percent of %CD8+CD28-CD57+ cells||95% Confidence Interval|Mean
2557812|NCT02703259|Secondary|Number of Patient With Gabapentin Adverse Effects at 24 Hours Postoperatively|Will assess for known symptoms of gabapentin postoperatively at 24 hours. We will survey subjects regarding their experience of the following symptoms: dizziness/drowsiness, fatigue, loss of balance, blurry vision, tremulousness, swelling, nausea, vomiting, diarrhea, and allergic reaction|24 hours||||Participants|||Count of Participants
2557656|NCT02706717|Secondary|Change in %CD4+CD28-CD57+ From Week 2 to Week 26.|Absolute change was calculated as the value at Week 26 minus the value at Week 2.|Weeks 2 and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 %CD4+CD28-CD57+ data were excluded.|||Percent of %CD4+CD28-CD57+ cells||95% Confidence Interval|Mean
2557657|NCT02706717|Secondary|Change in %CD8+CD38+HLA-DR+ From Week 2 to Week 26.|Absolute change was calculated as the value at Week 26 minus the value at Week 2.|Weeks 2 and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 %CD8+CD38+HLA-DR+ data were excluded.|||Percent of %CD8+CD38+HLA-DR+ cells||95% Confidence Interval|Mean
2557658|NCT02706717|Secondary|Change in %CD8+HLA-DR+ From Week 2 to Week 26.|%CD8+HLA-DR+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26|These data were not assayed and the analysis was abandoned.||||||
2557659|NCT02706717|Secondary|Change in %CD8+CD38+ From Week 2 to Week 26.|%CD8+CD38+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26|These data were not assayed and the analysis was abandoned.||||||
2557660|NCT02706717|Secondary|Change in %CD4+CD38+HLA-DR+ From Week 2 to Week 26.|Absolute change was calculated as the value at Week 26 minus the value at Week 2.|Weeks 2 and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 %CD4+CD38+HLA-DR+ data were excluded.|||Percent of %CD4+CD38+HLA-DR+ cells||95% Confidence Interval|Mean
2557661|NCT02706717|Secondary|Change in %CD4+HLA-DR+ From Week 2 to Week 26.|%CD4+HLA-DR+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26|These data were not assayed and the analysis was abandoned.||||||
2557662|NCT02706717|Secondary|Change in %CD4+CD38+ From Week 2 to Week 26.|%CD4+CD38+ data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26|These data were not assayed and the analysis was abandoned.||||||
2557663|NCT02706717|Secondary|Change in %CD14lowCD16hi From Week 2 to Week 26|%CD14lowCD16hi data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26|These data were not assayed and the analysis was abandoned.||||||
2557664|NCT02706717|Secondary|Change in %CD14++CD16+ From Week 2 to Week 26|Absolute change was calculated as the value at Week 26 minus the value at Week 2.|Weeks 2 and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 %CD14++CD16+ data were excluded.|||Percent of %CD14++CD16+ cells||95% Confidence Interval|Mean
2557665|NCT02706717|Secondary|Change in %CD14++CD16- From Week 2 to Week 26.|Absolute change was calculated as the value at Week 26 minus the value at Week 2.|Weeks 2 and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 %CD14++CD16- data were excluded.|||Percent of %CD14++CD16- cells||95% Confidence Interval|Mean
2557666|NCT02706717|Secondary|Change in CD4+/CD8+ Ratio From Week 2 to Week 26.|Fold change was calculated as the value at Week 26 divided by the value at Week 2.|Weeks 2 and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded.|||ratio||95% Confidence Interval|Mean
2557667|NCT02706717|Secondary|Change in CD4+ Cell Count From Week 2 to Week 26.|Absolute change was calculated as the value at Week 26 minus the value at Week 2.|Weeks 2 and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded.|||cells/mm^3||95% Confidence Interval|Mean
2557696|NCT02705807|Primary|Change From Baseline in Body Weight|Body weight was measured at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline'). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value. Participants with body weight outside and within the clinical concern reference range (<50kg) has been presented.|Baseline and Week 4|ITT population|||Participants|||Number
2557668|NCT02706717|Secondary|Change in LBP From Week 2 to Week 26|LBP data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26|These data were not assayed and the analysis was abandoned.||||||
2557669|NCT02706717|Secondary|Change in LPS From Week 2 to Week 26|LPS data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26|These data were not assayed and the analysis was abandoned.||||||
2557670|NCT02706717|Secondary|Change in D-dimer From Week 2 to Week 26|"All values were log10 transformed prior to calculating change and conducting analyses.~Absolute change was calculated as the value at Week 26 minus the value at Week 2. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change."|Weeks 2 and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 D-dimer data were excluded.|||Fold change||95% Confidence Interval|Mean
2557671|NCT02706717|Secondary|Change in Kynurenine to Tryptophan Ratio From Week 2 to Week 26|Fold change was calculated as the value at Week 26 divided by the value at Week 2.|Weeks 2 and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded.|||ratio||95% Confidence Interval|Mean
2557672|NCT02706717|Secondary|Change in Oxidized LDL From Week 2 to Week 26|Oxidized LDL data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26|These data were not assayed and the analysis was abandoned.||||||
2557673|NCT02706717|Secondary|Change in sTNF-RI From Week 2 to Week 26|sTNF-RI data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26|These data were not assayed and the analysis was abandoned.||||||
2557674|NCT02706717|Secondary|Change in sCD163 From Week 2 to Week 26|sCD163 data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26|These data were not assayed and the analysis was abandoned.||||||
2557675|NCT02706717|Secondary|Change in IP-10 From Week 2 to Week 26|"All values were log10 transformed prior to calculating change and conducting analyses.~Absolute change was calculated as the value at Week 26 minus the value at Week 2. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change."|Weeks 2 and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded. Additionally, participants without Week 2 and Week 26 IP-10 data were excluded.|||Fold change||95% Confidence Interval|Mean
2557676|NCT02706717|Secondary|Change in IL-6 From Week 2 to Week 26|IL-6 data are not available as of June, 2018. These data are based on assays which are to be tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 3 months after the primary completion date. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript.|Weeks 2 and 26|These data were not assayed and the analysis was abandoned.||||||
2557677|NCT02706717|Primary|Change in sCD14 From Baseline to Week 25/26|"Baseline is defined as the average of the Entry and Week 2 values. Week 25/26 is defined as the average of the Week 25 and Week 26 values.~Absolute change was calculated as the value at Week 25/26 minus the value at Baseline."|Weeks 0, 2, 25, and 26|Analysis used the per-protocol population. Participants 1) without Baseline AND Week 25/26 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) or with HIV-1 virologic failure were excluded.|||ug/L||95% Confidence Interval|Mean
2557678|NCT02706691|Secondary|Progression-free Survival||Up to 5 years|BGJ398 (Infigratinib) Dosing||||||
2557679|NCT02706691|Secondary|Overall Survival||Up to 5 years|BGJ398 (Infigratinib) Dosing||||||
2557680|NCT02706691|Secondary|Incidence of Adverse Events and Serious Adverse Events Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0||Through 30 days after end of study treatment|Study stopped after 1 patient enrolled. Endpoint could not be analyzed.||||||
2557681|NCT02706691|Primary|Objective Response Rate (Complete or Partial Response) Assessed by RECIST 1.1||Up to 5 years|Study stopped after 1 patient enrolled. Endpoint could not be analyzed.||||||
2557813|NCT02703259|Primary|Subjective Pain at 24 Hours Postoperative|Pain score assesses patient subjective pain via patient reported numeric analogue scale, range 0-10 with 0 being no pain and 10 being severe pain.|24 hours||||score on a scale||Standard Deviation|Mean
2557682|NCT02706327|Other Pre-specified|Vertical Jump Height Was Measured With a Special Mat|"Sensor mat was used in vertical jump measurement. The result is the distance (cm) that was jumped vertically and it is normalized by dividing the distance to length of subject in order to get percentage of jump distance.~Higher values mean better vertical jump performance. Participants were assessed after using the insoles for 8 weeks in order to get compliance.~Measurements were taken in the same day with and without insoles in shoes. Difference between with and without insole was calculated by subtracting the result with insole from the result without insole.~Therefore, positive changes mean better score with insole."|In the same session after 8 weeks|Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes.|||percentage of distance||Standard Deviation|Mean
2557683|NCT02706327|Other Pre-specified|Six-minute Walk Physiological Cost Index Was Calculated|"Physiological cost index was calculated by taking heart rate with finger oximeter and walking distance after a six-minute walk test.~The result is calculated by dividing one minute heart rate (beat) to walking distance (meter).~Lower values mean better physiological cost. Participants were assessed after using the insoles for 8 weeks in order to get compliance.~Measurements were taken in the same day with and without insoles in shoes. Difference between with and without insole was calculated by subtracting the result with insole from the result without insole.~Therefore, negative changes mean better score with insole."|In the same session after 8 weeks|Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes.|||beat/meter||Standard Deviation|Mean
2557684|NCT02706327|Other Pre-specified|Balance Was Assessed With a Dynamic Platform|"Dynamic platform was the equipment used in balance assessment. Participants were assessed after using the insoles for 8 weeks in order to get compliance.~Measurements were taken in the same day with and without insoles in shoes. The software calculates balance value between 0 and 5 that lower value means better balance score.~Difference between with and without insole was calculated by subtracting the result with insole from the result without insole.~Therefore, negative changes mean better balance score with insole."|In the same session after 8 weeks|Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes.|||units on a scale||Standard Deviation|Mean
2557685|NCT02706327|Secondary|Change in Quality of Life Assessed With Short Form-36 Scale|"The scale scores the health related quality of life with 0 and 100, minimum and maximum levels.~Each question is scored between 0-100 and the total score is found by dividing to number of question.~Higher score or positive change mean better quality of life in the scale. We used physical health part of it.~Changes were calculated as the difference between 8-week follow-up and baseline results."|Baseline and week 8||||units on a scale||Standard Deviation|Mean
2557686|NCT02706327|Primary|Change in Pain Intensity Measured by 100 mm Visual Analog Scale|"The scale scores the pain intensity with 0 and 100 mm, minimum and maximum levels.~Higher score means worse pain and also negative changes mean reduced pain. Participants were asked to rate the maximum level of foot pain they had in the last week.~Changes were calculated as the difference between 8-week follow-up and baseline results."|Baseline and week 8||||milimiters||Standard Deviation|Mean
2557687|NCT02705807|Secondary|Change From Baseline in Cardiac Output (CO)|Cardiac output is the volume of blood pumped by the heart per minute. The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline'). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Baseline and up to Week 4|ITT population|||liter/minute||Standard Deviation|Mean
2557688|NCT02705807|Secondary|Change From Baseline in Pulmonary Vascular Resist (PVR)|The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline'). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Baseline and up to Week 4|ITT population|||millimeter mercury/liter/minute||Standard Deviation|Mean
2557689|NCT02705807|Secondary|Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) and Mean Right Atrial Pressure (mRAP)|mPAP and mRAP are hemodynamic parameters. The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline'). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Baseline and up to Week 4|ITT Population|||mmHg||Standard Deviation|Mean
2557690|NCT02705807|Secondary|Number of Participants With Change of WHO Functional Class From Previous Visit|WHO Functional Classification of physical activity limitations: I (no limitation) and IV (unable to carry out any physical activity without symptoms). The change from baseline in WHO class was classified as Improved (decrease in functional class), No Change (functional class stayed the same), and Deteriorated (functional class increased). The change from baseline in WHO functional class at Week 4 has been presented in the table. The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline')|Up to Week 4|ITT population|||Participants|||Number
2557691|NCT02705807|Secondary|Number of Participants in Each World Health Organization (WHO) Functional Class|The WHO functional classes of PAH range from Class I (without limitation in physical activity) to Class IV (inability to perform a physical activity without any symptoms).|Baseline and Week 4|ITT population|||Participants|||Number
2557692|NCT02705807|Secondary|Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT Pro BNP)|Blood samples were collected at Baseline, 24 hours after the first dose of thermostable formulation of FLOLAN, and Week 4 for measurement of NT pro BNP. The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline'). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Baseline and up to Week 4|ITT population|||nanogram/liter||Standard Deviation|Mean
2557693|NCT02705807|Secondary|Number of Participants With the Reason for the Change Dose of the Thermostable Formulation of FLOLAN|All reasons for FLOLAN dose adjustments after the switch were listed.|Up to Week 4|ITT Population|||Participants|||Number
2557694|NCT02705807|Secondary|Number of Events to Adjust Dose of FLOLAN Based on the Change From Baseline to 3 Hours in Mean Pulmonary Artery Pressure (mPAP)|To assess the frequency of dose adjustment requirements based on the changes from baseline in mPAP up to 3 hours after dosing.The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline'). Participants who gave consent to undergo right heart catheterisation (RHC) over 24-hour and at week 4 were assessed. Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Up to Week 4|ITT population|||Number of events|||Number
2557698|NCT02705807|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured at Baseline, 1 hr, 3 hr, 24 hr, Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline'). Change from Baseline is defined as the difference between the post-dose visit value and the Baseline value.|Baseline, 1 hour, 3 hour, 24 hour and Week 4|ITT population|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2557699|NCT02705807|Primary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings|A safety 12-lead ECG was performed at Baseline (BL), 24 hr after switching to the new Flolan diluent and Week 4 (W4). Any abnormal clinically significant (CS) and not clinically significant (NCS) findings were reported. ECG abnormaility with respect to CS and NCS findings were judged by the investigator. The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline')|Baseline, 24 hour and Week 4|ITT population|||Participants|||Number
2557700|NCT02705807|Primary|Number of Participants With the Indicated Urinalysis Findings|Urine protein, urine glucose, and occult blood were assessed at Baseline (BL) and Week 4 (W4). Dipstick test was performed for routine urinalysis. Abnormal values such as trace, 1+, 2+, 3+ and positive have been reported. The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline').|Baseline and Week 4|ITT population|||Participants|||Number
2557701|NCT02705807|Primary|Absolute Values of Thyroid Stimulating Hormone at Baseline and Week 4|Blood samples were collected for measurement of Thyroid Stimulating Hormone (TSH) at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline')|Baseline and Week 4|ITT population|||milliunits per litre (mU/L)||Standard Deviation|Mean
2557702|NCT02705807|Primary|Absolute Values of Free Triiodothyronine and Free Thyroxine at Baseline and Week 4|Blood samples were collected for measurement of Free Triiodothyronine (FT3) and Free Thyroxine (FT4) at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline')|Baseline and Week 4|ITT population|||picomoles per litre (pmol/L)||Standard Deviation|Mean
2557703|NCT02705807|Primary|Absolute Values of Urea/Blood Urea Nitrogen, Glucose, Chloride, Sodium, Potassium, Magnesium, Phosphorus (Inorganic), and Calcium at Baseline and Week 4|Blood samples were collected for measurement of urea/Blood Urea Nitrogen (Urea/BUN), glucose, chloride, sodium, potassium, magnesium, phosphorus, inorganic, and calcium at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline')|Baseline and Week 4|ITT population|||Millimoles per litre (mmol/L)||Standard Deviation|Mean
2557704|NCT02705807|Primary|Absolute Values of Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Gamma Glutamyltransferase, Lactate Dehydrogenase and Creatine Kinase at Baseline and Week 4|Blood samples were collected for measurement of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Gamma Glutamyltransferase (GGT), Lactate Dehydrogenase (LDH) and Creatine Kinase (CK) at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline')|Baseline and Week 4|ITT population|||International units per liter (IU/L)||Standard Deviation|Mean
2557705|NCT02705807|Primary|Absolute Values of Total and Direct Bilirubin, Creatinine, and Uric Acid at Baseline and Week 4|Blood samples were collected for measurement of total and direct bilirubin, creatinine (CRT), and uric acid (UA) at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline')|Baseline and Week 4|ITT population|||Micromoles per liter||Standard Deviation|Mean
2557706|NCT02705807|Primary|Absolute Values of Albumin and Total Protein at Baseline and Week 4|Blood samples were collected for measurement of albumin and total protein at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline')|Baseline and Week 4|ITT population|||G/L||Standard Deviation|Mean
2557707|NCT02705807|Primary|Absolute Values of Red Blood Cell Count at Baseline and Week 4|Blood samples were collected for measurement of red blood cells at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline')|Baseline and Week 4|ITT population|||terabinary/liter (Ti/L))||Standard Deviation|Mean
2557708|NCT02705807|Primary|Absolute Values of Platelet Count and White Blood Cell Count at Baseline and Week 4|Blood samples were collected for measurement of platelets and white blood cells (WBC) at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline')|Baseline and Week 4|ITT population|||Giga/Liter (GI/L)||Standard Deviation|Mean
2557709|NCT02705807|Primary|Absolute Values of Hematocrit at Baseline and Week 4|Blood samples were collected for measurement of hematocrit values at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline')|Baseline and Week 4|ITT population|||Liter (L)||Standard Deviation|Mean
2557710|NCT02705807|Primary|Absolute Values of Hemoglobin at Baseline and Week 4|Blood samples were collected for measurement of hemoglobin values at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hr prior to the first dose of the new diluent formulation ('Visit 2 - Baseline')|Baseline and Week 4|ITT population|||Gram/Liter (G/L)||Standard Deviation|Mean
2557711|NCT02705807|Primary|Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in Blood at Baseline and Week 4|Blood samples were collected for the measurement of percentage of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils in blood at Baseline (BL) and Week 4 (W4). The Baseline values are those collected within 0.5 hour (hr) prior to the first dose of the new diluent formulation ('Visit 2 - Baseline')|Baseline and Week 4|ITT population|||Percentage||Standard Deviation|Mean
2557712|NCT02705807|Primary|Number of Participants With Mild, Moderate or Severe AEs|Intensity for an AE and SAE is categorized as mild if an event is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate if an event is sufficiently discomforting to interfere with normal everyday activities; severe if that prevents normal everyday activities.|Up to Week 4|ITT population|||Participants|||Number
2557713|NCT02705807|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical interventions. Intention-to-Treat (ITT) population: comprised of all participants who have received at least one dose of the thermostable formulation of FLOLAN.|Up to Week 4|ITT population|||Participants|||Number
2557714|NCT02705716|Secondary|Change From Baseline in Tactile Threshold on Day 7 and 14|Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.|Baseline, Day 7 and Day 14|Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n=number of participants evaluated at specific time points for each treatment arms respectively.|||g||Standard Deviation|Mean
2557715|NCT02705716|Secondary|Change From Baseline in Schiff Sensitivity Score on Day 7|Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.|Baseline, Day 7|Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is number of participants from ITT population evaluated on Day 7.|||score on a scale||Standard Deviation|Mean
2557716|NCT02705716|Primary|Change From Baseline in Schiff Sensitivity Score on Day 14|Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.|Baseline, Day 14|Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is number of participants from ITT population evaluated on Day 14.|||score on a scale||Standard Deviation|Mean
2557717|NCT02705625|Secondary|Creatinine Corrected Urine C-terminal Telopeptide of Collagen Type II (CTX-II) at Week 26|Change from Visit 2 (baseline) to Visit 8 (week 26) in creatinine corrected urine CTX-II, a biomarker for cartilage degradation.|baseline and 26 weeks|As there were discontinuations in the study, not all patients in the mITT population had an assessment at week 26. In addition, there was two missing samples for urine CTX-II. The analysis population is therefore smaller than in the Participant Flow.|||ng/mmol||Standard Deviation|Mean
2557718|NCT02705625|Secondary|Serum C-terminal Telopeptide of Collagen Type I (CTX-I) at Week 26|Change from Visit 2 (baseline) to Visit 8 (week 26) in serum CTX-I, a biomarker for bone resorption.|baseline and 26 weeks|As there were discontinuations in the study, not all patients in the mITT population had an assessment at week 26. In addition, there was one missing sample for serum CTX-I. The analysis population is therefore smaller than in the Participant Flow.|||ug/L||Standard Deviation|Mean
2557719|NCT02705625|Secondary|Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score|"Change from Visit 2 (Baseline) to Visit 8 (Week 26) in normalised WOMAC stiffness score. The WOMAC responses are scored using an 11-point NRS where 0=none and 10=extreme. There are 2 questions in the WOMAC stiffness scale which is summed up for the total WOMAC stiffness score, leading to a range of 0 to 20. The total WOMAC stiffness score has been standardised to a scale with a range from 0 to 100 (where 100 is extreme pain):~- Normalised WOMAC stiffness score = Total WOMAC stiffness score multiplicated with 5"|baseline and 26 weeks|As there were discontinuations in the study, not all patients in the mITT population had an assessment at week 26. The analysis population is therefore equal to the number of patients completing the study for this outcome measure.|||score||Standard Deviation|Mean
2557720|NCT02705625|Secondary|Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Difficulty Score|"Change from Visit 2 (Baseline) to Visit 8 (Week 26) in normalised WOMAC difficulty score. The WOMAC responses are scored using an 11-point NRS where 0=none and 10=extreme. There are 17 questions in the WOMAC difficulty scale which is summed up for the total WOMAC difficulty score, leading to a range of 0 to 170. The total WOMAC difficulty score has been standardised to a scale with a range from 0 to 100 (where 100 is extreme pain):~- Normalised WOMAC difficulty score = Total WOMAC difficulty score divided with 1.7"|baseline and 26 weeks|As there were discontinuations in the study, not all patients in the mITT population had an assessment at week 26. The analysis population is therefore equal to the number of patients completing the study for this outcome measure.|||score||Standard Deviation|Mean
2557738|NCT02704689|Secondary|Patient Reported Outcomes: Oswestry Disability Index Measurements for Comparison of Pre-operative to Post-operative Evaluations.|Patient Reported Outcomes: Oswestry Disability Index measurements for comparison of pre-operative to post-operative evaluations.|24 months|The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.||||||
2557721|NCT02705625|Secondary|Normalised Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain Score|"Change from Visit 2 (Baseline) to Visit 8 (Week 26) in normalised WOMAC pain score. The WOMAC responses are scored using an 11-point NRS where 0=none and 10=extreme. There are 5 questions in the WOMAC pain scale which is summed up for the total WOMAC score, leading to a range of 0 to 50. The total WOMAC pain score has been standardised to a scale with a range from 0 to 100 (where 100 is extreme pain):~- Normalised WOMAC pain score = Total WOMAC pain score multiplicated with 2."|baseline and 26 weeks|As there were discontinuations in the study, not all patients in the mITT population had an assessment at week 26. The analysis population is therefore equal to the number of patients completing the study for this outcome measure.|||score||Standard Deviation|Mean
2557722|NCT02705625|Secondary|Magnetic Resonance Imaging (MRI) of Cartilage Thickness (Femur) at Week 26|Change from Visit 2 (baseline) to Visit 8 (week 26) in MRI cartilage thickness in the Central Medial Femur Region of the target knee in mm.|baseline and 26 weeks|As there were discontinuations in the study, not all patients in the mITT population had an MRI assessment at week 26. In addition, there were patients with non valid MRIs. The analysis population is therefore smaller than the Participant Flow.|||mm||Standard Deviation|Mean
2557723|NCT02705625|Secondary|Magnetic Resonance Imaging (MRI) Bone Area of the Target Knee at Week 26|Change from Visit 2 (Baseline) to Visit 8 (Week 26) in MRI (Magnetic Resonance Imaging;) bone area of the target knee in mm^2.|baseline and 26 weeks|As there were discontinuations in the study, not all patients in the mITT population had an MRI assessment at week 26. In addition, there were patients with non valid MRIs. The analysis population is therefore smaller than the Participant Flow.|||mm^2||Standard Deviation|Mean
2557724|NCT02705625|Primary|Numeric Rating Scale (NRS) Average Target Knee Pain Score at Week 26|"Change from Visit 2 (Baseline) to Visit 8 (Week 26) in NRS average target knee pain score.~NRS (Numeric rating scale) ranges from 0 indicating -no pain, to 10 indicating - pain as bad as it could be."|baseline and 26 weeks|As there were discontinuations in the study, not all patients in the mITT population had an assessment at week 26. The analysis population is therefore equal to the number of patients completing the study for this outcome measure.|||score||Standard Deviation|Mean
2557725|NCT02705586|Primary|Salivary Cortisol Levels (Pre- and Post-) Mindfulness-Based Stress Reduction Program|Enzyme-linked immunoassay salivary cortisol levels (ng/mL) taken prior to Mindfulness-Based Stress Reduction will be compared to samples taken after the intervention.|Baseline to 12 weeks||||Concentration (ng/mL)||Standard Deviation|Mean
2557726|NCT02705365|Secondary|Tobacco Treatment Use|Percentage of patients, comparing intervention and control groups, who during the 1-year study period had referral to Massachusetts Quitline, smoking cessation medication prescribed, or referral to in-person counseling.|Up to 1 year||||Participants|||Count of Participants
2557727|NCT02705365|Primary|Chest CT Completion|Percentage of patients assigned to the intervention and control groups who had at least one chest CT (according to billing and EMR data) during the 1-year study period.|Up to 1 year||||Participants|||Count of Participants
2557728|NCT02705352|Secondary|Surgeon and Patient Satisfaction|"Patient and Observer Scar Assessment Scale (POSAS). This has 2 parts: Patient and Observer Scale. Both contain 6 items scored numerically on a 10 step scale (1 most normal, 10 worst scar imaginable). Together they sum to 'Total Score' of the Patient and Observer Scale. Category boxes are available to score nominal parameters (e.g. type of colour). Moreover, the patient and observer also score their 'Overall Opinion'. Total and subscales are averaged.~*There was 1 participant, and the score average was 1.*"|12 months|Unable to recruit more patients.|||score on a scale|||Number
2557729|NCT02705352|Secondary|Early Post-operative Complications|Surgery complications will be recorded, not related to treatment. Examples are wound dehiscence, graft necrosis, infection, bleeding, partial/complete graft failure and/or ectropion.|2 weeks after surgery|Unable to recruit more study patients.|||Number of events|||Number
2557730|NCT02705352|Secondary|Adverse Events|Treatment side effects will be recorded. Examples include pain, skin thinning, color/texture change, atrophy, telangiectasis, infection, and erythema.|12 months|Unable to recruit more study patients.|||Events|||Number
2557731|NCT02705352|Primary|Graft Size Change|Full thickness skin grafts will be measured prior to treatment (at time of surgery) and 12 months after surgery. Although the graft will be measured at each visit, the outcome is the percent change from baseline at 12 months.|12 months|One white male in study group|||percent change in graft|||Number
2557732|NCT02704702|Primary|Time to Reach Maximum Observed Plasma Concentration|This Outcome is the time it takes a drug to reach Cmax|For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period||||hr||Full Range|Median
2557733|NCT02704702|Primary|Maximum Observed Concentration|This Outcome is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated.|For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period||||ng/mL||95% Confidence Interval|Geometric Mean
2557734|NCT02704702|Primary|Area Under the Concentration-time Curve|This Outcome is the Area Calculated using the Linear Trapezoidal with Linear Interpolation Method|For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period||||ng*hr/mL||95% Confidence Interval|Geometric Mean
2557735|NCT02704689|Secondary|Radiographic Outcomes: Device Placement Status as Evaluated by X-ray and/or CT Imaging.|Radiographic Outcomes: Device placement status as evaluated by x-ray and/or CT imaging.|24 months|The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.||||||
2557736|NCT02704689|Secondary|Radiographic Outcomes: Fusion Status Evaluated by X-ray and/or CT Assessments.|Radiographic Outcomes: Fusion status evaluated by x-ray and/or CT assessments.|24 months|The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.||||||
2557739|NCT02704689|Secondary|Patient Reported Outcomes: Comparison of Pre-operative Back Pain Scores to Post-operative Levels as Measured by the (Visual Analog Scale (VAS).|Patient Reported Outcomes: Comparison of pre-operative back pain scores to post-operative levels as measured by the (Visual Analog Scale (VAS).|24 months|The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.||||||
2557740|NCT02704689|Secondary|Medical Outcomes: Comparison of Pre-operative Neurological Motors Assessments Evaluated by Straight Leg Raise, Femoral Stretch, and Strength Assessments, to Post-operative Findings.|Medical Outcomes: Comparison of pre-operative neurological Motors assessments evaluated by Straight Leg Raise, Femoral Stretch, and Strength assessments, to post-operative findings.|24 months|The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.||||||
2557741|NCT02704689|Secondary|Medical Outcomes: Comparison of Pre-operative Neurological Sensory Responses in the Lower Extremities to Post-operative Findings.|Medical Outcomes: Comparison of pre-operative neurological Sensory Responses in the lower extremities to post-operative findings.|24 months|The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.||||||
2557742|NCT02704689|Secondary|Medical Outcomes: Comparison of Pre-operative Neurological Reflex Evaluations in the Lower Extremities to Post-operative Findings|Medical Outcomes: Comparison of pre-operative neurological Reflex evaluations in the lower extremities to post-operative findings|24 months|The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.||||||
2557743|NCT02704689|Secondary|Medical Outcomes: Incidence of Complications Associated With the Procedure and/or Device.|Medical Outcomes: Incidence of complications associated with the procedure and/or device.|24 months|The Secondary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Secondary Outcome Measure.||||||
2557744|NCT02704689|Secondary|Surgical Outcomes: To Measure the Amount of Blood Loss at the Time of Surgery.|Surgical Outcomes: To measure the amount of blood loss at the time of surgery.|Operative Visit|Subjects treated with the AccuLIF TL device|||cc||Standard Deviation|Mean
2557745|NCT02704689|Secondary|Surgical Outcomes: To Evaluate the Length of Time Hospitalized for the Index Procedure as Measured in Days.|Surgical Outcomes: To evaluate the length of time hospitalized for the index procedure as measured in days.|Peri-op|Subjects treated with the AccuLIF TL device|||days||Standard Deviation|Mean
2557746|NCT02704689|Secondary|Surgical Outcomes: To Measure the Length of Surgery as Measured in Time of Surgery Duration.|Surgical Outcomes: To measure the length of surgery as measured in time of surgery duration.|Operative Visit|Subjects treated with the AccuLIF TL device|||minutes||Standard Deviation|Mean
2557747|NCT02704689|Primary|Pre-operative Comparison to Post-operative Radiographic Outcomes of Disc Height as Measured in mm.|Pre-operative comparison to post-operative radiographic outcomes of disc height as measured in mm.|24 months|The Primary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Primary Outcome Measure.||||||
2557748|NCT02704689|Primary|Post-operative Radiographic Measurements to Evaluate Segmental Lordosis as Measured by Degree of Change From Pre-operative X-rays.|Post-operative radiographic measurements to evaluate segmental lordosis as measured by degree of change from pre-operative x-rays.|24 months|The Primary Outcome Measures were going to be analyzed at the 24 month visit. However, this study was terminated early due to lack of enrollment and no subjects reached the 24 month analysis visit. There is, therefore, no data to summarize for this Primary Outcome Measure.||||||
2557749|NCT02704104|Other Pre-specified|Time to Hemostasis in Patients Who Were Taking or Not Taking Anti Platelet Medication||Day 0|The overall number of patients is 46, 10 of whom were taking anti platelet therapy at the time of the procedure.|||seconds||Full Range|Median
2557750|NCT02704104|Secondary|Number of Wounds With ASEPSIS Wound Scores of 0 at Day 7 and Day 30|The Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay longer than 14 days (ASEPSIS) Wound Score (reference 1) was used to assess wound healing and overall wound sepsis. This multipoint system is reported as a total score ranging from 0 to 30 points in the first 7 days postoperatively. Additional points after 7 days can be added for additional treatments such as use of antibiotics, drainage of pus under local anesthesia, and debridement of the wound; and isolation of bacteria or duration of stay, for a total score of from 0 to 70 points by day 30. Total scores from 0-10 indicate satisfactory healing, from 11 to 20=disturbance of healing, from 21 to 30=minor wound infection, from 31 to 40=moderate wound infection, and >40 points signifies severe infection. For this study, the number of wounds with ASEPSIS score = 0 was counted.|7 and 30 Days Post Procedure|Analysis is performed per wound (2/patient, one randomized to AC5 the second to control), that is, 46 patients with a total of 96 wounds.|||wounds|||Number
2557751|NCT02704104|Secondary|Time to Hemostasis in Seconds Per Square Centimeter Wound Area|Measure of time from application of treatment or control to the wound, to bleeding cessation/ divided by wound area|At time of application (Day 0)|Analysis is performed per wound (2/patient, one randomized to AC5 the second to control), that is, 46 patients with a total of 96 wounds.|||seconds/cm2||Full Range|Median
2557752|NCT02704104|Secondary|Median Time to Hemostasis (Seconds)|Measure of time from application of treatment or control to the wound, to bleeding cessation|At time of application (Day 0)|Analysis is performed per wound (2/patient, one randomized to AC5 the second to control), that is, 46 patients with a total of 96 wounds.|||seconds||Full Range|Median
2557753|NCT02704104|Primary|Number of Participants With Treatment-emergent Adverse Events Related to Clinical Investigation Product During the 30 Days of Follow-up|"Local reactions to clinical investigation product (pain, edema, rash, cellulitis, localized infectious processes, other) detected during clinical investigation follow up.~Systemic reactions after administration of clinical investigation product (fever, allergic reaction, anaphylaxis or any clinical untoward event) detected during clinical investigation follow up."|30 Days Post Procedure||||Participants|||Count of Participants
2557754|NCT02704091|Secondary|Abdominal Pain Intensity Scores, Per 12-Hour Period|Abdominal pain intensity per 12-hour period was recorded in the DEB. Abdominal pain intensity was rated with a 5-point ordinal scale: 0 = absent, 1= mild, 2 =moderate, 3 = severe, 4= very severe. Higher scores indicate a worse outcome. The median abdominal pain intensity score for each 12-hour period is presented.|From randomisation (Day 1) up to Day 9|The ITT population included all randomised participants (with the exception of those excluded from the analysis), analysed according to the arm to which they were randomised. Only participants with data available at each specified time point were included in the analysis.|||Scores on a scale||Full Range|Median
2557755|NCT02704091|Secondary|Percentage of Participants With Associated Symptoms, Per 12-Hour Period|Percentage of participants with associated symptoms (at least 1 symptom of nausea, vomiting, abdominal pain or anal irritation) per 12-hour period is presented. Nausea, vomiting, abdominal pain and anal irritation were recorded in the DEB.|From randomisation (Day 1) up to Day 9|The ITT population included all randomised participants (with the exception of those excluded from the analysis), analysed according to the arm to which they were randomised. Only participants with data available at each specified time point were included in the analysis.|||Percentage of participants|||Number
2557756|NCT02704091|Secondary|Number of Watery Stools, Per 12-Hour Period|Number of watery stools, per 12-hour period, was recorded in the DEB.|From randomisation (Day 1) up to Day 9|The ITT population included all randomised participants (with the exception of those excluded from the analysis), analysed according to the arm to which they were randomised. Only participants with data available at each specified time point were included in the analysis.|||Stools||Full Range|Median
2557757|NCT02704091|Secondary|Number of Stools, Per 12-Hour Period|Number of stools, per 12-hour period, was recorded in the DEB.|From randomisation (Day 1) up to Day 9|The ITT population included all randomised participants (with the exception of those excluded from the analysis), analysed according to the arm to which they were randomised. Only participants with data available at each specified time point were included in the analysis.|||Stools||Full Range|Median
2557758|NCT02704091|Secondary|Time From the First Study Treatment Intake to the Last Watery Stool|The event of first study treatment intake was recorded in the eCRF and the event of last watery stool was recorded in the DEB. Results are presented as median time from first study treatment intake to last watery stool, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn with no watery stool or ending the study with no watery stool were censored at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).|From randomisation (Day 1) up to Day 9|The ITT population included all randomised participants (except for those excluded from the analysis), analysed according to the arm to which they were randomised.|||Hours||95% Confidence Interval|Median
2557759|NCT02704091|Secondary|Time From Diarrhoea Onset to First Formed Stool|The event of diarrhoea onset (i.e. loose or watery stool) was recorded in the eCRF and the event of first formed stool was recorded in the DEB. Results are presented as median time from diarrhoea onset to first formed stool, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn with no formed stool or ending the study with no formed stool were censored at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).|From randomisation (Day 1) up to Day 9|The ITT population included all randomised participants (with the exception of those excluded from the analysis), analysed according to the arm to which they were randomised. Only participants with data available were included in the analysis.|||Hours||Full Range|Median
2557760|NCT02704091|Secondary|Time From Diarrhoea Onset to Recovery|The event of diarrhoea onset (i.e. loose or watery stool) was recorded in the eCRF and the event of recovery (i.e. first formed stool followed by a non-watery stool) was recorded in the DEB. Results are presented as median time from diarrhoea onset to recovery, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn without recovery or ending the study without recovery were censored (not responders) at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).|From randomisation (Day 1) up to Day 9|The ITT population included all randomised participants (with the exception of those excluded from the analysis), analysed according to the arm to which they were randomised. Only participants with data available were included in the analysis.|||Hours||95% Confidence Interval|Median
2557761|NCT02704091|Primary|Time to Recovery|Time to recovery was defined as the time from the first study treatment intake recorded in the electronic case report form (eCRF) to the first formed stool followed by a non-watery stool, recorded in the DEB. Results are presented as median time to recovery, calculated using the Kaplan-Meier technique. Participants prematurely withdrawn without recovery or ending the study without recovery were censored (not responders) at the date/time of their last stool as recorded in the DEB. Participants who had not filled in the DEB (i.e. no post-baseline evaluation of stools) were censored at the date/time of their first study treatment intake (or the randomisation date/time if not administered).|From randomisation (Day 1) up to Day 9|The ITT population included all randomised participants (except for those excluded from the analysis), analysed according to the arm to which they were randomised.|||Hours||95% Confidence Interval|Median
2557814|NCT02703259|Primary|Narcotic Use at 24 Hours Postop|Assessment of the amount of narcotic use postoperatively at 24 hours. will use opioid equivalence table to convert all narcotic use to oxycodone equivalents|24 hours||||morphine milligram equivalents||Standard Deviation|Mean
2558686|NCT02690194|Primary|Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate|Pre-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute.|Pre-therapy/pre-procedure||||Breaths per minute||Standard Deviation|Mean
2557762|NCT02703987|Secondary|Square Root of Postprandial Incremental Area Under Curve (iAUC) of Hydrogen Concentration From 30 Minutes to 240 Minutes|The iAUC of hydrogen concentration from 30 to 240 minute sampling time points is calculated with the triangular rule (reference: Wolever TM. Effect of blood sampling schedule and method of calculating the area under the curve on validity and precision of glycaemic index values. Br J Nutr. 2004 Feb;91(2):295-301). The square root of the iAUC is then taken for the outcome measure|Hydrogen in breath within 4 hours after ingestion of study product; samples taken at 30 minute intervals for 4 hours, i.e. at 30, 60, 90, 120, 150, 180, 210 and 240 minutes at Visits 3 and 4|"At Visit 3, 14 subjects took the control product and at Visit 4, 13 subjects took the control product. Therefore, 27 subjects took the control product in total.~At Visit 3, 14 subjects took the test product and at Visit 4, 11 subjects took the test product. Therefore, 25 subjects took the test product in total."|||sqrt(ppm*min)||Standard Error|Least Squares Mean
2557763|NCT02703987|Primary|Log of Maximum Postprandial Change in Hydrogen Concentration|This is measured as the maximum change in postprandial hydrogen concentration (ppm) compared to baseline between 90 minutes and 240 minutes|Maximum postprandial hydrogen in breath within 4 hours after ingestion of study product; samples taken at 30 minute intervals for 4 hours, i.e. at 90, 120, 150, 180, 210 and 240 minutes at Visits 3 and 4|"At Visit 3, 14 subjects took the control product and at Visit 4, 13 subjects took the control product. Therefore, 27 subjects took the control product in total.~At Visit 3, 14 subjects took the test product and at Visit 4, 11 subjects took the test product. Therefore, 25 subjects took the test product in total."|||log(ppm)||Standard Error|Least Squares Mean
2557764|NCT02703987|Primary|Log of First Postprandial Peak Change of Hydrogen Concentration|This is measured as the log of the first change >20ppm peak value compared to baseline between 90 minutes and 240 minutes. If there was no change >20ppm at all between 90 minutes and 240 minutes, it is the maximum change compared to baseline in that interval|Postprandial peak hydrogen in breath within 4 hours after ingestion of study product; samples taken at 30 minute intervals for 4 hours, i.e. at 90, 120, 150, 180, 210 and 240 minutes at Visits 3 and 4|"At Visit 3, 14 subjects took the control product and at Visit 4, 13 subjects took the control product. Therefore, 27 subjects took the control product in total.~At Visit 3, 14 subjects took the test product and at Visit 4, 11 subjects took the test product. Therefore, 25 subjects took the test product in total."|||log(ppm)||Standard Error|Least Squares Mean
2557765|NCT02703948|Primary|Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine||12 weeks||||Participants|||Count of Participants
2557766|NCT02703909|Secondary|Postoperative Opioid Requirement|The participants will be given iv fentanyl or hydromorphone after surgery. They will also be given po oxycodone. The investigators will collect data on the amount of opioid that is required after surgery. This will be reported as morphine equivalents using the morphine equivalent calculator at:|day of surgery until hospital discharge (approximately 2-3 days)|Only 24 of the patients had an IP of 10 mm throughout the surgery. The remainder of the patients either had IP of 15 mm throughout the surgery or were increased to 15 mm at the start of the surgery.|||morphine equivalents||Standard Deviation|Mean
2557767|NCT02703909|Secondary|Number and Percentage of Subjects With Success at Low (10 mm) Insufflation Pressure|The patients will be randomized to an initial insufflation pressure of 10 or 15 mm hg. If the surgeons are not satisfied with the initial operating conditions, the insufflating pressure will be increase to 15 mm Hg (if not already at that level). This will be reported as the percentage of patients who were able to have their entire surgery performed at an insufflation pressure of 10 mm Hg.|day of surgery|The percentage of patients who were able to have their surgery completed at an IP of 10 mm|||Participants|||Count of Participants
2557768|NCT02703909|Primary|Surgeon Satisfaction Scale|The surgeon will grade his satisfaction with the surgical conditions using a 5 point scale with 1 - extremely poor; 2 - poor; 3 - acceptable; 4. good; 5 - optimal surgical conditions|day of surgery||||Scores on a scale||Standard Deviation|Mean
2557769|NCT02703636|Secondary|Formulation Usability Questionnaire Form Score up to Week 24|"Evaluation of the formulation usability of rivastigmine patch for up to 24 weeks as measured by the formulation usability questionnaire answered by caregiver.~The Formulation usability preference questionnaire had been used to compare the previous oral AD drugs versus the patch The caregiver selects one of the following answers (1. Very easy to use, 2. Easy to use, 3. No change, 4. Not easy to use, 5. Not easy to use at all, 6. Unknown).~This questionnaire data is used to assess if the usability of rivastigmine patch was preferred by the majority (> 50%) of AD patient caregivers or not.~Unabbreviated Questionnaire title:~Formulation Usability questionnaire Minimum Score = 1 Maximum Score = 6~A higher score indicates its not easy to use and worse outcome."|Up to week 24|FAS|||Participants|||Count of Participants
2557770|NCT02703636|Secondary|Change in as Modified Crichton Scale Score From Baseline to Week 4, 8, 16 and 24|"Evaluation of the efficacy of rivastigmine patch with 1-step titration measured as Modified Crichton Scale score week 4, week 8, week 16, and week 24.~Modified Crichton Scale that assess basic activation of daily living, communication functions, and quality of life The following 7 items will be evaluated by caregiver. Total score is in the 0 to 56 range. Higher score means more severe impairment.~Unabbreviated Scale Title: Modified Crichton scale Minimum score = 0 Maximum Score = 56 Higher score indicates worse outcome"|baseline, weeks 4, 8, 16, 24|"FAS~The number of participants analysed per row (modified crichton scale) differs from overall number of participants because this is based on available data and patient continuation/discontinuation during that respective study period."|||scores on a scale||Standard Deviation|Mean
2557771|NCT02703636|Secondary|Change in J-CGIC Score From Baseline and at Week 24|"Evaluation of the efficacy of rivastigmine patch with 1-step titration measured as the The Japanese-Clinical Global Impression of Change (J-CGIC) score at baseline and week 24~J-CGIC is a 7-grade investigator's impression scale: 1. Markedly improved, 2. Improved, 3. Slightly improved, 4. No change, 5. Slightly aggravated, 6. Aggravated, 7. Markedly aggravated~At week 24, 103 patients had available data~Total score is in the 0 to 56 range. Higher score means more severe impairment.~Unabbreviated scale title: Japanese -Cinical Global Impression of Change Minimum Score - 1 Maximum Score - 7"|baseline and week 24|FAS|||Participants|||Count of Participants
2557834|NCT02702193|Secondary|Trajectory of Oral Health Problems of Participants|Self-reported oral health as measured by the Oral Health Impact Profile. Each item is scored 1-5, yielding a total between 14 and 70.|baseline, 4, 8 and 12 months|Intent to Treat analysis|||Participants|||Count of Participants
2557772|NCT02703636|Secondary|Change in QOL-AD Score From Baseline to Week 24|"Evaluation of the efficacy of rivastigmine patch with 1-step titration measured as QOL-AD score at week 24.~Unabbreviated Scale Name: Quality of Life - Alzheimer's Disease Minimum Score = 13 Maximum Score = 52~Higher value indicates a better outcome~QOL-AD is a 13-item questionnaire to assess the quality of life of Alzheimer's patients from the perspectives of patients and their caregivers. It covers several aspects, for example, the perception of health status, mood, functional capacity, personal relationships and leisure, financial situation, and life as a whole. Each item is quantified using a Likert scale with score one classified as poor, and score four as excellent where total scores range from 13 to 52. A lower score indicates more severe impairment."|baseline and week 24|"FAS~The number of participants analysed per row differs from overall number of participants because this is based on available data and patient continuation/discontinuation during that respective study period."|||scores on a scale||Standard Deviation|Mean
2557773|NCT02703636|Secondary|Change in Neuropsychiatric Inventory - 10 Item (NPI-10) Score From Baseline to Week 8 and Week 24|"Evaluation of the efficacy of rivastigmine patch with 1-step titration measured as the Neuropsychiatric Inventory - 10 Item (NPI-10) score at week 8 and week 24.~Per protocol, Neuropsychiatric The NPI-10 total score is a sum of the 10 items, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and all domains are equally weighted for the total score (thus the range for the total score is 0 to 120).~A higher score indicates more severe impairment.~Neuropsychiatry Inventory - 10 Minimum Score = 0 Maximum Score = 120~Higher Score indicates worse outcome"|baseline, week 8, week 24|FAS The number of participants analysed per row differs from overall number of participants because this is based on available data and patient continuation/discontinuation during that respective study period.|||scores on a scale||Standard Deviation|Mean
2557774|NCT02703636|Secondary|Change From Baseline to Week 8 in Mini-Mental State Examination (MMSE) Total Score|"Evaluation of the efficacy of rivastigmine patch with 1-step titration measured as the MMSE score at week 8 for patients who had 1-step titration~MMSE total score: change from baseline to Week 8 and Week 24 for patients who had 1-step titration~Unabbreviated Scale : MMSE - Mini Mental State Evaluation:~Minimum values - 0 Maximum value - 30 Higher Value means a better outcome~Positive change score from baseline indicates better outcome"|baseline and week 8|FAS|||scores on a scale||Standard Deviation|Mean
2557775|NCT02703636|Secondary|MMSE Total Score: Change From Baseline to Week 8 and Week 24|"Evaluation of the safety, tolerability of rivastigmine patch with 1-step titration for up to 24 weeks.~Per Protocol, The MMSE is a brief, practical screening test for cognitive dysfunction. The MMSE consists of 2 parts: language (time orientation, registration and attention) and performance (recall, response to written/verbal commands, writing ability and reproduction of complex polygons), and the total possible score is 30. Lower score indicates more severe impairment. It is the most common and simple cognitive scale for Alzheimer's disease.~Unabbreviated Scale : MMSE - Mini Mental State Evaluation:~Minimum values - 0 Maximum value - 30 Higher Value means a better outcome~Positive change score from baseline indicates improvement in cognitive function"|baseline, weeks 8 and 24|Per Protocol Set (PPS): The per protocol set includes all patients in the FAS who had only 1 step titration without any major deviations from the protocol procedures|||scores on a scale||Standard Deviation|Mean
2557776|NCT02703636|Primary|MMSE Total Score: Change From Baseline to Week 8 and Week 24 (Full Analysis Set)|"Evaluation of the efficacy of rivastigmine patch with 1-step titration on cognitive function measured as change from baseline to week 24 in the total score of MMSE in mild to moderate Alzheimer's disease (AD) patients who failed to benefit from other cholinesterase inhibitors (ChEIs)~The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.~Abbreviated Scale title: Mini Mental State Evaluation Minimum Score: 0 Maximum score: 30 Higher score indicated better cognitive function"|baseline, weeks 8 and 24|The full analysis set (FAS) included all patients who received at least one dose of study treatment and had at least a baseline and any post-baseline assessment on treatment|||scores on a scale||Standard Deviation|Mean
2557777|NCT02703532|Secondary|Post Study System Usability Questionnaire (PSSUQ) Score|The PSSUQ is a 19-item survey that measures users' perceived satisfaction with a product or system. Responses are given on a 7-point scale where 1 = strongly agree and 7 = strongly disagree. Responses are averaged to provide a total score between 1 and 7 where low answers indicate greater ease with using the CARE-CITE system.|Post-treatment (up to Week 3)|This analysis includes carepartners who were in the CARE-CITE intervention study arm.|||score on a scale||Standard Deviation|Mean
2557778|NCT02703532|Secondary|Caregiving Self Efficacy (Obtaining Respite Scale) Score|The Caregiving Self Efficacy (Obtaining Respite Scale) measures the carepartner's self-efficacy for obtaining respite from caregiving. Five items are rated on a 0-100 scale where 0 = cannot do at all, 50 = moderately certain can do, and 100 = certain can do. A total score is obtained by averaging scores for the individual items. Total scores range from 0 to 100 with higher scores indicating that the carepartner has greater confidence in keeping up with their own activities while providing care to the stroke survivor.|Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)|This analysis includes carepartners completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.|||score on a scale||Standard Error|Mean
2557779|NCT02703532|Secondary|Bakas Caregiving Outcomes Scale (BCOS) Score|The BCOS is a 16-item scale asking about changes in the carepartner's social functioning, subjective well-being and physical health since they began caring for the stroke survivor. Participants responded to statements on a 7-point Likert scale (1=changed for the worst, 7=changed for the best). Total scores range from 16 to 112. Scores below 64 indicate that caring for the stroke survivor has resulted in negative changes, while scores above 64 indicate positive changes.|Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)|This analysis includes carepartners completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.|||score on a scale||Standard Error|Mean
2557780|NCT02703532|Secondary|Caregiver Strain Index (CSI) Score|"The CSI is a 12-question instrument measuring strain related to care provision. Carepartners respond to different statements with either yes or no where yes = 1 and no = 0. Total scores range from 0 to 12 with 0 indicating no caregiver strain and 12 indicating extreme strain. Positive responses to seven or more items on the index indicate a greater level of stress related to care giving."|Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)|This analysis includes carepartners completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.|||score on a scale||Standard Error|Mean
2557781|NCT02703532|Secondary|Piper Fatigue Scale (PFS) Score|The Piper Fatigue Scale (PFS) is composed of 22 numerically scaled (0 to 10) items measuring four dimensions of subjective fatigue: behavioral/severity, affective meaning, sensory, and cognitive/mood. The total fatigue score is the average score for all questionnaire items and ranges from 0 to 10, where higher scores indicate greater fatigue.|Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)|This analysis includes carepartners completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.|||score on a scale||Standard Error|Mean
2557782|NCT02703532|Secondary|Autonomy Support Family Care Climate Questionnaire for Carepartner (FCCQ-CP) Scale Score|Autonomy support for carepartners will be assessed by the Autonomy Support Family Care Climate Questionnaire for Carepartner (FCCQ-CP) Scale.An autonomy supportive environment is characterized by empathy, communicating choice (avoiding controlling language), providing rationales and problem solving. Questions are asked about the carepartner's perspective on how much they provide an autonomy supportive environment for the stroke survivor. The FCCQ-CP includes 14 items scored from 1 to 7 where 1 = not true at all and 7 = very true. Item scores are averaged to provide an overall score between 1 and 7 where higher scores indicate the carepartner thinks they are providing high autonomy support to the stroke survivor.|Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)|This analysis includes carepartners completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.|||score on a scale||Standard Error|Mean
2557783|NCT02703532|Secondary|Memory and Behavior Problems Checklist (MBPC) - Problem Frequency Score|The MBPC is a 19-item caregiver-report instrument assessing observable behavioral problems in a loved one with dementia. Carepartners report how frequently problem behaviors occur on a scale from 0 to 4 where 0 = never occurs and 4 = occurs daily. Total scores range from 0 to 76, where higher scores indicate greater frequency of problematic behavior.|Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)|This analysis includes carepartners completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.|||score on a scale||Standard Error|Mean
2557784|NCT02703532|Secondary|Stroke Impact Scale (SIS) Score|Quality of life will be assessed using the Stroke Impact Scale (SIS). The SIS is a stroke specific, self report questionnaire (59 items across 8 domains) that measures how a stroke has impacted a participant's health and life, including strength, memory and thinking, emotions and mood, communication, activities of daily living, mobility, function of affected upper extremity, and participation. Each item is rated in a 5-point Likert scale in terms of the difficulty the participant has experienced in completing each item. A score for each domain is obtained, ranging from 0 to 100 where higher scores indicate greater ability to perform tasks.|Baseline, 1 Month Post-treatment (up to Week 7)|This analysis includes stroke survivors completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.|||score on a scale||Standard Error|Mean
2557785|NCT02703532|Secondary|Confidence in Arm and Hand (CAHM) Scale Score|Upper extremity self-efficacy will be assessed by the Confidence in Arm and Hand (CAHM) scale. The CAHM is a 20-item scale that examines self-efficacy for arm and hand function of the impaired upper extremity in individuals following stroke. Items are worded to assess task-specific self-confidence for unimanual and bilateral paretic arm and hand activities typically performed in home and community contexts. Items are scored on a scale of 0 (very uncertain) to 100 (very certain) and averaged to provide a total scale score ranging from 0 to 100. Higher scores indicate greater confidence with performing daily tasks with the impacted arm.|Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)|This analysis includes stroke survivors completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.|||score on a scale||Standard Error|Mean
2557786|NCT02703532|Secondary|Fugl-Meyer Assessment (FMA) Score|Upper extremity impairment will be assessed by the Fugl-Meyer Assessment (FMA). The FMA includes 33 items that evaluate and measure recovery in post-stroke hemiplegic patients. Items are scored on a 3-point ordinal scale, from 0 to 2. Total scores range from 0 to 66 and higher scores indicates greater arm function.|Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)|This analysis includes stroke survivors completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.|||score on a scale||Standard Error|Mean
2557799|NCT02703350|Secondary|Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) (Part B)|PD: AUC(0-5h) of Glucose Relative to a MMTT (Part B)|Days 1 and 14: Day 1: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes in each study period|All participants in Part B who received study drug and had evaluable PD data. Data were excluded if the participant did not keep identical insulin lispro dose during the MMTT assessments, did not complete the entire test meal, or had significant changes in nutrient consumption of the test meal.|||mg*h/dL||Standard Deviation|Mean
2557787|NCT02703532|Secondary|Autonomy Support Family Care Climate Questionnaire for Stroke Survivor (FCCQ-SS) Score|Autonomy support will be assessed using the Autonomy Support Family Care Climate Questionnaire for Stroke Survivor (FCCQ-SS). An autonomy supportive environment is characterized by empathy, communicating choice (avoiding controlling language), providing rationales and problem solving. Questions are asked about the stroke survivor's perspective on how much the carepartner provides an autonomy supportive environment for the stroke survivor. The FCCQ-SS includes 14 items scored from 1 to 7 where 1 = not true at all and 7 = very true. Item scores are averaged to provide an overall score between 1 and 7 where higher scores indicate the stroke survivor perceives receiving high autonomy support from the carepartner.|Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)|This analysis includes stroke survivors completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.|||score on a scale||Standard Error|Mean
2557788|NCT02703532|Primary|Center for Epidemiologic Studies Depression Scale (CES-D) Score|Depressive symptoms among carepartners will be assessed by the Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a screening test for depression and depressive disorder. The CES-D measures the frequency and severity of 20 depressive symptoms experienced during the last week. Each item is scored from 0 to 3 where 0 = rarely and 3 = most days and certain items are reverse scored so that greater symptomatology is assigned a higher score. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression. Scores of 16 or greater are considered as an indicator of potential clinical depression.|Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)|This analysis includes carepartners completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.|||score on a scale||Standard Error|Mean
2557789|NCT02703532|Primary|Family Caregiver Conflict Scale (FCCS) Score|"Family conflict will be assessed using the Family Caregiver Conflict Scale (FCCS). The FCCS is 15-item scale that measures family conflict between caregivers and other family by assessing disagreements over caring for the care recipient with items such as: We have disagreements when I ask family members to help me take care of our relative. Items are scored from 1 to 7 where 1 = not true at all and 7 = very true. total scores range from 15 to 105 and higher scores indicate greater family conflict."|Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)|This analysis includes carepartners completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.|||score on a scale||Standard Error|Mean
2557790|NCT02703532|Primary|Motor Activity Log (MAL) Score|Upper extremity function and use will be assessed using the Motor Activity Log (MAL). The MAL is a semi-structured interview to assess arm function. Participants are asked to rate quality of movement (QOM) during 28 daily functional tasks. Items are scored on a 6-point ordinal scale, from 0 to 5, where 0 = the affected arm was of no use and 5 = affected arm is functioning normally. The total score is the average of all items and ranges from 0 to 5, where higher values indicate greater function of the arm that was impacted by the stroke.|Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)|This analysis includes stroke survivors completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.|||score on a scale||Standard Error|Mean
2557791|NCT02703532|Primary|Wolf Motor Function Test (WMFT)|Motor ability and impairments will be assessed using the Wolf Motor Function Test (WMFT) an assessment tool used to evaluate upper extremity performance while providing insight into joint-specific and total limb movements. Values represent the amount of time, in seconds, to complete the assessment. Lower scores (faster speed) are indicative of higher functioning levels.|Baseline, Post-treatment (up to Week 3), 1 Month Post-treatment (up to Week 7)|This analysis includes stroke survivors completing the study visits; two carepartner and stroke survivor dyads in the CARE-CITE intervention were lost to follow-up between the end of treatment and the one month follow-up, and one dyad in the control group withdrew between the baseline visit and post-treatment visit.|||seconds||Standard Deviation|Mean
2557792|NCT02703467|Secondary|Blood Hydrogen Sulpide Level|Hydrogen Sulpide level measurements from blood|At 4 visits which occur during the study duration, up to 1 year|Data not collected||||||
2557793|NCT02703467|Secondary|Exhaled Nitric Oxide|Levels of nitric oxide in exhaled breath in parts per billion|At 4 visits which occur during the study duration, up to 1 year||||parts per billion||Standard Error|Mean
2557794|NCT02703467|Secondary|FVC (Forced Vital Capacity)|Forced vital capacity as per cent of predicted|At 4 visits which occur during the study duration, up to 1 year||||per cent of predicted value (%)||Standard Error|Mean
2557795|NCT02703467|Secondary|FEV1|Forced expiratory volume in one second as percent of predicted value (%)|At baseline visit||||per cent of predicted value||Standard Error|Mean
2557796|NCT02703467|Primary|Hydrogen Sulphide in Exhaled Breath|Level of hydrogen sulphide in exhaled breath measured as parts per billion|At baseline visit||||parts per billion||Standard Error|Mean
2557797|NCT02703454|Secondary|Number of Participants With Freedom From Procedure-related Serious Adverse Events|Freedom from procedure-related serious adverse events within one year of the index procedure|Within 1 year post study treatment|Subjects with 12 month safety data|||Participants|||Count of Participants
2557798|NCT02703454|Primary|Number of Participants With Single-procedure Freedom From AF/AT Recurrence From 3-12 Months Post Index Ablation Procedure|Freedom from AF/AT recurrence is defined as no documented episodes of AF/AT > 30 seconds with conventional non-invasive monitoring. In the case of a cardiac implanted electronic device (CIED), freedom from AF recurrence is defined as no documented episodes of AF/AT > 30 seconds in a 72-hour window at the follow-up visits in addition to any symptomatic episodes with documented AF > 30 seconds. AT recurrence does not include episodes of cavotricuspid isthmus (CTI) dependent flutter.|3 -12 months post study treatment.|Patients with 12-month follow-up data|||Participants|||Count of Participants
2557800|NCT02703350|Secondary|Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) (Part A)|PD: AUC(0-5h) of Glucose Relative to a MMTT (Part A)|Day 1: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes|All participants in Part A who received study drug immediately before a meal (0 min) and had evaluable PD data. Data were excluded if the participant did not keep identical insulin lispro dose during the MMTT assessments, did not complete the entire test meal, or had significant changes in nutrient consumption of the test meal.|||milligram*hour/deciliter (mg*h/dL)||Standard Deviation|Mean
2557801|NCT02703350|Primary|Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part B)|PK: Insulin Lispro AUC(0-5h) (Part B)|Days 1 and 14: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, 300 minutes post dose for each treatment|All participants in Part B who received study drug and had evaluable PK data.|||pmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2557802|NCT02703350|Primary|Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part A)|PK: Insulin Lispro AUC(0-5h) (Part A)|Day 1: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, 300 minutes post dose for each treatment|All participants in Part A who received study drug and had evaluable PK data. For one participant in the LY900014 - Test (Part A) group, the insulin lispro PK profile (period three) was excluded from the mean PK analysis, as there was no absorption phase observed.|||picomole*hour per liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2557803|NCT02703337|Secondary|Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) (Part B)|PD: AUC(0-5h) of Glucose Relative to a MMTT (Part B)|Days 1 and 14: Day 1: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes in each study period|All participants in Part B who received study drug and had evaluable PD data. Data were excluded if the participant did not keep identical insulin lispro dose during the MMTT assessments, did not complete the entire test meal, or had significant changes in nutrient consumption of the test meal.|||mg*h/dL||Standard Deviation|Mean
2557804|NCT02703337|Secondary|Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) (Part A)|PD: AUC(0-5h) of Glucose Relative to a MMTT (Part A)|Day 1: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes|All participants in Part A who received study drug immediately before a meal (0 min) and had evaluable PD data. Data were excluded if the participant did not keep identical insulin lispro dose during the MMTT assessments, did not complete the entire test meal, or had significant changes in nutrient consumption of the test meal.|||milligram*hour/deciliter (mg*h/dL)||Standard Deviation|Mean
2557805|NCT02703337|Primary|Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part B)|PK: Insulin Lispro AUC(0-5h) (Part B)|Days 1 and 14: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, 300 minutes post dose for each treatment|All participants in Part B who received study drug and had evaluable PK data.|||pmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2557806|NCT02703337|Primary|Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part A)|PK: Insulin Lispro AUC(0-5h) (Part A)|Day 1: 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, 300 minutes post dose for each treatment|All participants in Part A who received study drug and had evaluable PK data. For one participant in the LY900014 - Test (Part A) group, the insulin lispro PK profile (period two) was excluded from the mean PK analysis, as there was no absorption phase observed.|||picomole*hour per liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2557807|NCT02703324|Secondary|Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)|PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)|Days 1 and 3: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes post dose for each treatment|All participants who received study drug and had evaluable PD data.|||milligram*hour/deciliter (mg*h/dL)||Standard Deviation|Mean
2557808|NCT02703324|Primary|Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h])|PK: Insulin Lispro AUC(0-5h)|Days 1 and 3: -15, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300 minutes post dose for each treatment|All participants who received both study drugs and had evaluable PK data. For one participant in the Insulin Lispro - Reference group, the insulin lispro PK profile (Period Two, Day 3) was excluded from the mean PK analysis, as there was no absorption phase observed.|||picomole*hour per liter (pmol•h/L)||Geometric Coefficient of Variation|Geometric Least Squares Mean
2557809|NCT02703259|Secondary|Subjective Pain at 2 Weeks Postop|"Assessment of the subject pain score postoperatively at 2 weeks. will use a numeric analog scale from 0-10.~The pain scale ranging from 0-10 with 0 representing No Pain and 10 representing the Worst Pain Possible"|2 weeks|participants included in analysis differs from participant flow due to subjects loss to follow up at the 2 weeks time frame. study powered to primary outcome at 24 hours postoperative. 10 subjects were lost to follow up at 2 weeks postoperative in both the gabapentin and control arm.|||score on a scale||Standard Deviation|Mean
2557810|NCT02703259|Secondary|Narcotic Use at 2 Weeks Postop|Assessment of the amount of narcotic use postoperatively at 2 weeks. will use opioid equivalence table to convert all narcotic use to oxycodone equivalents|2 weeks||||morphine milligram equivalents||Standard Deviation|Mean
2557811|NCT02703259|Secondary|Number of Patient With Gabapentin Adverse Effects at 2 Weeks Postoperatively|Will assess for known symptoms of gabapentin postoperatively at 2 weeks. We will survey subjects regarding their experience of the following symptoms: dizziness/drowsiness, fatigue, loss of balance, blurry vision, tremulousness, swelling, nausea, vomiting, diarrhea, and allergic reaction|2 weeks|participants included in analysis differs from participant flow due to subjects loss to follow up at the 2 weeks time frame. study powered to primary outcome at 24 hours postoperative. 10 subjects were lost to follow up at 2 weeks postoperative in both the gabapentin and control arm.|||Participants|||Count of Participants
2558687|NCT02690194|Primary|Pre-therapy/Pre-procedure Stress Level Measured by Pulse|Pre-therapy/pre-procedure stress level measured by pulse in beats per minute.|Pre-therapy/pre-procedure||||Beats per minute||Standard Deviation|Mean
2557815|NCT02702999|Secondary|Number of Participants With Composite Maternal Morbidity|Composite Maternal Morbidity is defined as the presence of one of more of the following: 1) chorioamnionitis; 2) cesarean delivery in labor; 3) wound infection; 4) transfusion; 5) deep venous thrombus or pulmonary embolism; 6) admission to intensive care unit; 7) postpartum hemorrhage; or 8) death.|From time of delivery to discharge (average time of discharge is 4 days after delivery)|One patient in the routine third trimester care group delivered in an outside hospital, and the data was not available.|||Participants|||Count of Participants
2557816|NCT02702999|Secondary|Number of Participants With Composite Neonatal Morbidity|Composite Neonatal Morbidity is defined as the presence of one or more of the following: 1) Apgar score < 5 at 5 min; 2) umbilical arterial pH < 7.00; 3) intraventricular hemorrhage grade III or IV; 4) periventricular leukomalacia; 5) intubation for over 24 hrs; 6) necrotizing enterocolitis grade 2 or 3; 7) stillbirth; or 8) death within 28 days of birth.|From time of delivery to 28 days after delivery|One patient in the routine third trimester care group delivered in an outside hospital, and the data was not available.|||Participants|||Count of Participants
2557817|NCT02702999|Primary|Number of Participates With Polyhydraminos|"Polyhydraminos is a condition in pregnancy characterized by an excess of amniotic fluid. Amniotic fluid was assessed using either the amniotic fluid index (AFI) or maximum vertical pocket (MVP). Polyhydramnios was defined as AFI greater than or equal to 24.0 cm or MVP greater than or equal to 8.0 cm.~AFI is the sum of the vertical length of the deepest, unobstructed pocket of amniotic fluid in each of the 4 quadrants of the pregnant uterus. An AFI of less than or equal to 5cm is considered low amniotic fluid, and an AFI greater than or equal to 24cm is considered high amniotic fluid.~MVP is the vertical length of the single deepest pocket of amniotic fluid. An MVP less than or equal to 2cm is considered to be low amniotic fluid and an MVP of 8cm or greater is considered to be high amniotic fluid.~Both low and high amniotic fluid levels are worse outcomes than having normal amniotic fluid levels."|30 to 38 weeks gestational age||||Participants|||Count of Participants
2557818|NCT02702999|Primary|Number of Participates With Oligohydraminos|"Oligohydramnios is a condition in pregnancy characterized by a deficiency of amniotic fluid. Amniotic fluid was assessed using the amniotic fluid index (AFI) or maximum vertical pocket (MVP). Oligohydramnios was defined as AFI less than or equal to 5.0 cm or MVP less than or equal to 2.0 cm.~AFI is the sum of the vertical length of the deepest, unobstructed pocket of amniotic fluid in each of the 4 quadrants of the pregnant uterus. An AFI of less than or equal to 5cm is considered low amniotic fluid, and an AFI greater than or equal to 24cm is considered high amniotic fluid.~MVP is the vertical length of the single deepest pocket of amniotic fluid. An MVP less than or equal to 2cm is considered to be low amniotic fluid and an MVP of 8cm or greater is considered to be high amniotic fluid.~Both low and high amniotic fluid levels are worse outcomes than having normal amniotic fluid levels."|30 to 38 weeks gestational age||||Participants|||Count of Participants
2557819|NCT02702999|Primary|Number of Participants With Large for Gestational Age Fetuses||30 to 38 weeks gestational age||||Participants|||Count of Participants
2557820|NCT02702999|Primary|Number of Participants With Fetal Growth Restriction||30 to 38 weeks gestational age||||Participants|||Count of Participants
2557821|NCT02702921|Secondary|Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding|"Incidence of hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of SOC or PVS:~Hemostasis intervention: bleeding that occurs post-operatively requiring blood or blood product transfusion or an additional surgical procedure (related to PA and PV transection).~No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection)."|Post-Op through 4 Week Followup|A total of 229 subjects were screened and 201 subjects were randomized into the study – 98 randomized to SOC and 103 randomized to PVS. Two subjects randomized to SOC stapler received the PVS stapler. These subjects are included in the PVS group for safety analysis.|||Proportion participants w/ intervention|Participant|95% Confidence Interval|Number
2557822|NCT02702921|Primary|Incidence of Intra-Operative Hemostatic Intervention|Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Pulmonary Artery and Pulmonary Vein during Video Assisted Thoracoscopic lobectomy with the use of standard of care stapler (SOC) or powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open).|Intra-Operative, an average of 2.3 hours, ranging from 30 mintues to 6.4 hours|A total of 229 subjects were screened and 201 subjects were randomized into the study – 98 randomized to SOC and 103 randomized to PVS. Two subjects randomized to SOC stapler received the PVS group. These subjects are included in the stapler group for the primary endpoint analysis, consistent with the intention-to-treat principle.|||Proportion transections w/ intervention|Vessels Transection|95% Confidence Interval|Number
2557823|NCT02702401|Secondary|Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented. These results are based on a 02-Jan-2019 data cutoff date.|From Day 1 through end of treatment (Up to approximately 24 months)|The analysis population included participants who received ≥1 dose of study treatment. Participants were grouped by actual treatment received.|||Participants|||Count of Participants
2557835|NCT02702193|Secondary|Trajectory of Physical Function of Participants|Self-reported physical function over the past 7 days as measured by the PROMIS 29 physical function subscale. Each item is scored 1-5, yielding a total between 4 and 20, with higher scores indicating better physical function.|baseline, 4, 8 and 12 months|Intent to Treat analysis|||Participants|||Count of Participants
2558688|NCT02690194|Primary|Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure|Pre-therapy/pre-procedure stress level measured by blood pressure in mmHg|Pre-therapy/pre-procedure||||mmHg||Standard Deviation|Mean
2557824|NCT02702401|Secondary|Number of Participants Who Experienced At Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented. These safety results are based on a 02-Jan-2019 data cutoff date.|Through database cutoff date of 02-Jan-2019 (Up to approximately 30 months)|The analysis population included participants who received ≥1 dose of study treatment. Participants were grouped by actual treatment received.|||Participants|||Count of Participants
2557825|NCT02702401|Secondary|Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|DOR was determined in participants who demonstrated a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesion was also considered PD. The DOR was analyzed using the product-limit (Kaplan-Meier) method for censored data.|From time of first documented evidence of CR or PR through database cutoff date of 02-Jan-2019 (Up to approximately 30 months)|The analysis population included all randomized participants who demonstrated at least a partial response. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2557826|NCT02702401|Secondary|Time to Progression (TTP) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesion was also considered PD. If there was no documented disease progression, TTP was censored at last tumor assessment date. The TTP was analyzed using the product-limit (Kaplan-Meier) method for censored data. TTP per RECIST 1.1 is presented for all participants.|Through database cutoff date of 02-Jan-2019 (Up to approximately 30 months)|The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2557827|NCT02702401|Secondary|Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|DCR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions), Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), or Stable Disease (SD) per RECIST 1.1 after ≥6 weeks as assessed by Blinded Independent Central Review (BICR). The DCR was analyzed using the Miettinen & Nurminen method. The percentage of participants who experienced a CR, PR, or SD is presented.|Through database cutoff date of 02-Jan-2019 (Up to approximately 30 months)|The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2557828|NCT02702401|Secondary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|ORR was determined in all participants and was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. The ORR was analyzed using the Miettinen & Nurminen method. The percentage of participants who experienced a CR or PR per RECIST 1.1 is presented.|Through database cutoff date of 02-Jan-2019 (Up to approximately 30 months)|The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2557829|NCT02702401|Primary|Overall Survival (OS)|OS was determined for all participants and was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last follow-up. The OS was analyzed using the product-limit (Kaplan-Meier) method for censored data. The OS for all participants is presented.|Through database cutoff date of 02-Jan-2019 (Up to approximately 30 months)|The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2557830|NCT02702401|Primary|Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesion was also considered PD. If there was no disease progression or death, participants were censored at the date of their last disease assessment. The PFS was analyzed using the product-limit (Kaplan-Meier) method for censored data. The primary analysis of PFS was performed at the time of the first interim analysis of OS (as pre-specified in the protocol), with data cutoff of 26-Mar-2018.|Through database cutoff date of 26-Mar-2018 (Up to approximately 21 months)|The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2557831|NCT02702193|Secondary|Trajectory of Illicit Drug Use of Participants|Self-reported Illicit Drug Use as measured by the Addiction Severity Index.|baseline, 4, 8 and 12 months|Intent to Treat analysis|||Participants|||Count of Participants
2557832|NCT02702193|Secondary|Trajectory of Alcohol Intoxication of Participants|Self-reported Alcohol Intoxication as measured by the Addiction Severity Index.|baseline, 4, 8 and 12 months|Intent to Treat analysis|||Participants|||Count of Participants
2557833|NCT02702193|Secondary|Trajectory of Daily Smoking of Participants|Self-reported Daily Smoking as measured by the Addiction Severity Index.|baseline, 4, 8 and 12 months|Intent to Treat analysis|||Participants|||Count of Participants
2557838|NCT02702193|Secondary|Trajectory of Sleep Disturbance of Participants|Self-reported experience with sleep disturbance over the past 7 days as measured by the PROMIS 29 sleep disturbance subscale . Each item is scored 1-5, yielding a total between 4 and 20.|baseline, 4, 8 and 12 months|Intent to Treat analysis|||Participants|||Count of Participants
2557839|NCT02702193|Primary|Trajectory of Anxiety of Participants|Self-reported experience with anxiety symptoms as measured by the PROMIS anxiety scale over the past 7 days. Each item is scored 1-5 (1 = Never; 5 = Always), yielding a total between 8 and 40.|baseline, 4, 8 and 12 months|Intent to Treat analysis|||Participants|||Count of Participants
2557840|NCT02702193|Primary|Trajectory of Depression of Participants|Self-reported experience with depressive symptoms as measured by the PROMIS depression scale over the past 7 days. Each item is scored 1-5 (1 = Never; 5 = Always), yielding a total between 8 and 40.|baseline, 4, 8 and 12 months|Intent to Treat analysis|||Participants|||Count of Participants
2557841|NCT02702011|Primary|Change From Baseline in 24 Hour UGE on Day 7|Change from baseline in 24 hour urinary glucose excretion on Day 7 calculated as: UGE on Day 7 - UGE on baseline. Baseline is defined as the last observation prior to the first intake of any randomised trial medication.|Baseline and 7 days|The primary analysis was performed on the FAS with last observation carried forward (LOCF) imputation.|||gram per 24 hours (g/24 h)||Standard Error|Least Squares Mean
2557842|NCT02701985|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline up to Week 14|The safety population included all participants, who received at least one dose of the study medication. Participants were grouped according to the treatment actually received.|||Percentage of participants|||Number
2557843|NCT02701985|Secondary|Average Concentration (Caverage) of RO5459072|Average observed plasma concentration (mass/volume)|Week 2, Week 6, and Week 12|The safety population included all participants, who received at least one dose of the study medication. Participants were grouped according to the treatment actually received.|||ng/mL||90% Confidence Interval|Median
2557844|NCT02701985|Secondary|Maximum Concentration (Cmax) of RO5459072|Maximum observed plasma concentration (mass/volume)|Week 2, Week 6, and Week 12|The safety population included all participants, who received at least one dose of the study medication. Participants were grouped according to the treatment actually received.|||ng/mL||90% Confidence Interval|Median
2557845|NCT02701985|Secondary|Minimum Concentration (Cmin) of RO5459072|Minimum observed plasma concentration (mass/volume)|Week 2, Week 6, and Week 12|The safety population included all participants, who received at least one dose of the study medication. Participants were grouped according to the treatment actually received.|||ng/mL||90% Confidence Interval|Median
2557846|NCT02701985|Secondary|Change From Baseline in Total Immunoglobulin M (IgM) at Weeks 6, and 12|Total IgM is a type of auto-antibody found in the auto-antibody titers.|Baseline, Week 6, and Week 12|The safety population included all participants, who received at least one dose of the study medication. Participants were grouped according to the treatment actually received.|||g/L||Standard Deviation|Mean
2557847|NCT02701985|Secondary|Change From Baseline in Total Immunoglobulin G (IgG) at Weeks 6, and 12|Total IgG is a type of auto-antibody found in the auto-antibody titers.|Baseline, Week 6, and Week 12|The safety population included all participants, who received at least one dose of the study medication. Participants were grouped according to the treatment actually received.|||g/L||Standard Deviation|Mean
2557848|NCT02701985|Secondary|Change From Baseline in Rheumatoid Factor at Weeks 6, and 12|Rheumatoid factor is a type of auto-antibody found in the auto-antibody titers.|Baseline, Week 6, and Week 12|The safety population included all participants, who received at least one dose of the study medication. Participants were grouped according to the treatment actually received.|||kU/L||Standard Deviation|Mean
2557849|NCT02701985|Secondary|Change From Baseline in Anti-Sjögren's-Syndrome-Related Antigen B at Weeks 6, and 12|Anti-Sjögren's-syndrome-related antigen B is a type of antibody found in the auto-antibody titers.|Baseline, Week 6, and Week 12|The safety population included all participants, who received at least one dose of the study medication. Participants were grouped according to the treatment actually received.|||U/mL||Standard Deviation|Mean
2557850|NCT02701985|Secondary|Change From Baseline in Anti-Sjögren's-Syndrome-Related Antigen A at Weeks 6, and 12|Anti-Sjögren's-syndrome-related antigen A is a type of antibody found in the auto-antibody titers.|Baseline, Week 6, and Week 12|The safety population included all participants, who received at least one dose of the study medication. Participants were grouped according to the treatment actually received.|||U/mL||Standard Deviation|Mean
2557851|NCT02701985|Secondary|Change From Baseline in Mechanically Stimulated Salivary Flow Rate at Weeks 2, 6, and 12|Change from baseline in mechanically stimulated salivary flow rate is defined as the change in flow (mL/min) between baseline (Week -1) and Week 2, Week 6 and Week 12. Using a mechanical stimulation method of a piece of neutral wax, paraffin, silicone, unflavored chewing gum, or similar chewable, unflavored, nonabsorbent material, patients were instructed to chew for a period of 5 minutes. The stimulated salivary flow rate was calculated assuming a specific gravity of 1 (i.e., 1 mL saliva = 1 g) and expressed in mL per minute.|Baseline, Week 2, Week 6, and Week 12|mITT population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||mL/min||Standard Deviation|Mean
2557852|NCT02701985|Secondary|Change From Baseline in Tear Flow Rate at Weeks 2, 6, and 12|Un-stimulated tear production rate was measured from both eyes (without the use of analgesics/ anesthetic drops) at baseline and at on-treatment visits using the Schirmer method. A thin strip of filter paper (Schirmer strip, e.g., 35 x 5 mm) was placed at the junction of the lateral and middle thirds of the lower eyelid of each eye. The maximum length of wetting along the strip at the end of the test period was measured.|Baseline, Week 2, Week 6, and Week 12|mITT population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||mm/5 min||Standard Deviation|Mean
2557853|NCT02701985|Secondary|Change From Baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Pain Component Score at Week 12|Change from baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) pain component score is defined as the change in score between baseline (Week -1) and Week 12. The ESSPRI score consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (Each domain scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable).|Baseline (Week -1), Week 12|mITT population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||Score on a scale||Standard Deviation|Mean
2557854|NCT02701985|Secondary|Change From Baseline in ESSPRI Fatigue Component Score at Week 12|Change from baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) fatigue component score is defined as the change in score between baseline (Week -1) and Week 12. The ESSPRI score consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable).|Baseline (Week -1), Week 12|mITT population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||Score on a scale||Standard Deviation|Mean
2557855|NCT02701985|Secondary|Change From Baseline in ESSPRI Dryness Component Score at Week 12|Change from baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) dryness component score is defined as the change in score between baseline (Week -1) and Week 12. The Dryness Component score ranged from 0-10 (0 =no symptom at all and 10 = worst symptom imaginable).|Baseline (Week -1), Week 12|mITT population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||Score on a scale||Standard Deviation|Mean
2557856|NCT02701985|Secondary|Change From Baseline in SF-36 Physical Score at Week 12|Change from baseline in Short Form-36 Health Survey (SF-36) Physical Score is defined as the change in score between baseline (Week -1) and Week 12. The SF-36 was used to assess health-related quality of life at baseline and at on-treatment visits. The SF-36 consisted of 36 questions covering 8 domains (general health, physical functioning, role-functioning physical, bodily pain, social functioning, role-functioning emotional, mental health, and vitality), with each domain scoring on a scale 0-100. (a score of 0 = maximum disability and a score of 100 = no disability)|Baseline (Week -1), Week 12|mITT population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||Score on a scale||Standard Deviation|Mean
2557857|NCT02701985|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Score at Week 12|Change from baseline in Short Form-36 Health Survey (SF-36) Mental score is defined as the change in score between baseline (Week -1) and Week 12. The SF-36 was used to assess health-related quality of life at baseline and at on-treatment visits. The SF-36 consisted of 36 questions covering 8 domains (general health, physical functioning, role-functioning physical, bodily pain, social functioning, role-functioning emotional, mental health, and vitality), with each domain scoring on a scale 0-100 (a score of 0 = maximum disability and a score of 100 = no disability). Reported here is the mental health domain score.|Baseline (Week -1), Week 12|mITT population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||Score on a scale||Standard Deviation|Mean
2557858|NCT02701985|Secondary|Change From Baseline in ESSPRI Score at Week 12|Change from baseline in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score is defined as the change in score between baseline (Week -1) and Week 12. The ESSPRI is a patient-reported, subjective symptom index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight.|Baseline (Week -1), Week 12|mITT population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||Score on a scale||Standard Deviation|Mean
2557859|NCT02701985|Secondary|Change From Baseline in ESSDAI Score at Week 12|Change from baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score is defined as the change in score between baseline (Week -1) and Week 12. The ESSDAI is a physician-assessed disease activity index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of 44 items in 12 organ-specific 'domains' contributing to disease activity (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. An overall score is then calculated as the sum of all individual weighted domain scores. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity).|Baseline (Week -1), Week 12|mITT population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||scores on a scale||Standard Deviation|Mean
2557871|NCT02701647|Other Pre-specified|Gradient of the Recruitment Curve ( Also Known as Stimulus-response Curve)|TMS stimuli will be applied at 10% steps between 100% to 160% RMT. 10 stimuli will be delivered at each intensity. Peak to peak amplitude of 10 motor-evoked potentials (MEPs) at each stimulus intensity will be averaged offline.The cut-off intensity is set at 75% of maximum stimulator output due to discomfort perceived by majority of the participants. MEPs will be normalised with the maximal muscle action potential (MMax), which is determined by supramaximal electrical stimulation of the fibular nerve. A scatter graph will be generated with the average amplitude of MEPs as a function of stimulation intensity. The linear trend will be added to generate the linear recruitment curve slope.|Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention|2 sets of discarded data due to poor quality|||millivolts / % maximum stimulator output||Standard Deviation|Mean
2557860|NCT02701985|Secondary|Percentage of Participants With a Clinically Relevant Decrease in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score|The efficacy of RO5459072 in patients with primary Sjogren's Syndrome Disease is evaluated in terms of the percentage of participants with a clinically relevant decrease in EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score, where a clinically relevant decrease in ESSPRI score is defined as a decrease of ≥ 1 point. The ESSPRI is a patient-reported, subjective symptom index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains where all domains carry same weight.|12 weeks|mITT population was defined as all randomized participants, who received any study medication and had evaluable measument of the parameter of interest at baseline and at least one post-baseline visit.|||Percentage of Participants||95% Confidence Interval|Number
2557861|NCT02701985|Primary|Percentage of Participants With a Clinically Relevant Decrease in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score|Percentage of participants with a clinically relevant decrease in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) Score is defined as participants with absolute decrease of ≥ 3-points in ESSDAI score. ESSDAI is physician-assessed disease activity index developed by EULAR consortium consisting of 44 items in 12 organ-specific 'domains' (constitutional,lymphadenopathy, articular,muscular,cutaneous,glandular,pulmonary,renal,peripheral nervous system,central nervous system,hematological,biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A score ≥ 5 is considered moderate or severe disease activity and a clinically relevant change in ESSDAI score is defined as absolute decrease of ≥ 3-points.|12 weeks|Modified intent-to-treat (mITT) population was defined as all randomized participants, who received any study medication and had evaluable measurement of the parameter of interest at baseline and at least one post-baseline visit.|||Percentage of Participants||95% Confidence Interval|Number
2557862|NCT02701764|Secondary|Eye Pain as Assessed by the Numeric Rating Scale (NRS)|NRS total score ranges from 0-10 over a one week recall period with the higher score indicating increased pain. Absolute scores will be reported from NRS questionnaire completed at 3 and 6 month visit.|3 months, 6 months|One participant in the placebo group did not complete the 6 month visit.|||score on a scale||Standard Deviation|Mean
2557863|NCT02701764|Secondary|Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Affective|sf-MPQ Affective has a total score ranging from 0-12 with a higher score indicating increased pain. Absolute scores will be reported from sf-MPQ Affective questionnaire completed at 3 and 6 month visit.|3 months, 6 months|One participant in the placebo group did not complete the 6 month visit.|||score on a scale||Standard Deviation|Mean
2557864|NCT02701764|Secondary|Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Sensory|sf-MPQ Sensory has a total score ranging from 0-33 with a higher score indicating increased pain. Absolute scores will be reported from sf-MPQ Sensory questionnaire completed at 3 and 6 month visit.|3 months, 6 months|One participant in the placebo group did not complete the 6 month visit.|||score on a scale||Standard Deviation|Mean
2557865|NCT02701764|Secondary|Eye Pain as Evaluated by the Neuropathic Pain Symptom Inventory - Eye (NPSI-E)|NPSI-E total score ranges from 0-100 with a higher score indicating increased eye pain. Absolute scores will be reported from NPSI-Eye questionnaire completed at 3 and 6 month visit.|3 months, 6 months|One participant in the placebo group did not complete the 6 month visit.|||score on a scale||Standard Deviation|Mean
2557866|NCT02701764|Secondary|Tear Evaporation Measured by Tear Break up Time (TBUT)|Participant will have 5 μl of preservative free fluorescein placed on their eye. The participant will then be positioned in the head rest of the slit lamp instrument and will be instructed to blink three times naturally and then not blink. The integrity of the tear film will be measured and, using a stopwatch, the time from the last blink until one or more black (dry) spots appear in the precorneal tear film will be recorded as TBUT. The absolute scores for TBUT completed on the 3 and 6 month visit will be reported.|3 months, 6 months|One participant in the placebo group did not complete 6 month visit|||Seconds||Standard Deviation|Mean
2557867|NCT02701764|Secondary|Tear Production Measured by Schirmers Score|Tear production will be measured via Schirmers score. Schirmer strips will be placed in the outer 1/3 of the lower conjunctivae. The Schirmer score will be evaluated as the length of wetting in mm in the Schirmer strips after 5 minutes. Absolute scores will be reported for the tear production evaluation at the 3 and 6 months visit.|3 months, 6 months|One participant in the placebo group did not complete the 6 month visit|||mm wetting||Standard Deviation|Mean
2557868|NCT02701764|Secondary|Dry Eye Symptoms as Evaluated by the Ocular Surface Disease Index (OSDI)|OSDI total score ranges from 0-100 with a higher score indicating greater disability. Absolute scores will be reported from OSDI questionnaire completed at 3 and 6 month visit.|3 months, 6 months|One participant in the placebo group did not complete the 6 month visit.|||score on a scale||Standard Deviation|Mean
2557869|NCT02701764|Primary|Severity of Dry Eye Symptoms as Assessed by the Dry Eye Questionnaire - 5 (DEQ5)|DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye. Absolute score will be reported from DEQ5 questionnaire completed at 6 month visit.|6 months|One participant in the placebo group did not complete 6 month visit|||score on a scale||Standard Deviation|Mean
2557870|NCT02701647|Other Pre-specified|Short-interval-intracortical Inhibition|Short-interval-intracortical inhibition (SICI) is another measure of cortical inhibition. In a paired- pulse TMS paradigm, a test pulse will be adjusted to produce MEP of at least 0.5 millivolts which will be delivered preceded by a brief conditioned pulse set at a lower intensity of 80% RMT with inter-stimulus interval of 2 milliseconds. Two stimulators connected via a Bistim module ( Magstim Co.,Whitland, UK) will be used in this test. Ten conditioned MEPs and unconditioned MEPs will be obtained in a random order and were averaged for each condition. SICI is expressed as percentage of unconditioned test MEP amplitude.|Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention|unable to perform procedure due to small MEPS values for 5 participants|||percentage of Unconditioned MEPs||Standard Deviation|Mean
2557872|NCT02701647|Other Pre-specified|Cortical Silent Period|Ten suprathreshold TMS stimuli (i.e. 130% RMT) will be delivered while participant performing a 20% isometric maximal contraction of Tibialis Anterior of the more affected side. Cortical silent period (CSP) measures the duration of interruption of electromyography (EMG) activity in the contracting muscle produced by TMS. CSP duration will be determined as the period between the onset of MEP and the return of baseline EMG activity measured 50 ms before the TMS stimulus.|Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention|1 discarded data due to poor quality of data|||milliseconds||Standard Deviation|Mean
2557873|NCT02701647|Secondary|Dual-task Timed-Up-and-Go Test (DT-TUG)|For DT-TUG, participants were instructured to repeat the TUG procedure while performing a serial three substraction. Time taken to complete DT-TUG and accuracy of digital counting was recorded. One practice trial was given prior to both TUG and DT-TUG testing and average performance of three trials was used for analysis.|Baseline, 1 day post-intervention, 1 month post-intervention, 3 month-post intervention||||seconds||Standard Deviation|Mean
2557874|NCT02701647|Secondary|Mini Balance Evaluation Systems Test Scores|Balance performance of participants will be assessed in 4 domains namely anticipatory postural adjustments, postural responses, sensory orientation and gait stability. Each item is rated from 0-2 with a total scores of 28. The Total scores range from 0-28, with higher scores indicate better dynamic balance.|Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention||||score on a scale||Standard Deviation|Mean
2557875|NCT02701647|Secondary|Walking Distance in a 2 -Minute Walk Test|"The 2 minute walk test will be conducted along a 20 m x 2 m hallway. A line is marked at each end of the walkway to indicate where the person is to turn. Participants will be instructed to  walk as far as possible in 2 minutes. They will be given standardised encouragement at 60 and 90 seconds during walk. Distance walked will be recorded to the nearest meter."|Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention||||meter||Standard Deviation|Mean
2557876|NCT02701647|Secondary|the Motor Section of Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS III)|MDS-UPDRS III is a valid and reliable clinical test, will be used to evaluate severity of motor symptoms of PD. There are total of 27 items including tremor, rigidity, bradykinesia, postural instability and gait performance. Each item scores from 0-4, with 0 indicates no disability and 4 maximum disabled with total score(s) ranges from 0 to 132.|Baseline, I day post-intervention, 1 month post-intervention and 3 months post-intervention||||score on a scale||Standard Deviation|Mean
2557877|NCT02701647|Secondary|Timed-Up-and-Go Test (iTUG)|"Participants are instructed to stand up from a chair and walk for 7 meters walkway and return back to the chair turn around and sit down.~Time and gait parameters during TUG were captured by the valid and reliable APDM system, which is a wearable gait and balance analysis system."|Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention||||seconds||Standard Deviation|Mean
2557878|NCT02701647|Primary|Fastest Walking Speed|Each participant is instructed to walk for 14 meters at their fastest walking speed for three trials. The time taken for the middle 10 meter was recorded. The average of three trials is used for analysis.|Baseline, 1 day post-intervention, 1 month post-intervention, 3 month post-intervention||||cm/s||Standard Deviation|Mean
2557879|NCT02701634|Secondary|Percentage of Participants Who Experienced Treatment-Emergent Graded Laboratory Abnormalities||Up to 48 weeks plus 30 days|Safety Analysis Set|||Percentage of participants|||Number
2557880|NCT02701634|Secondary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 48 weeks plus 30 days|Safety Analysis Set|||Percentage of participants|||Number
2557881|NCT02701634|Secondary|Percentage of Participants Who Experience Any Treatment-Emergent Adverse Events (AEs)|Treatment-emergent adverse events are defined as 1 or both of the following: 1) any AEs with an onset on or after study drug or placebo start date and no later than earlier of 30 days after permanent discontinuation of study drug or placebo, 2) any AEs leading to premature discontinuation of study drug or placebo.|Up to 48 weeks plus 30 days|Safety Analysis Set: all participants who received at least 1 dose of study drug, with treatment assignments designated according to actual treatment received.|||Percentage of participants|||Number
2557882|NCT02701634|Secondary|Failure-Free Survival|Failure-free survival was defined as the time from randomization to the earliest of first documentation of systemic therapy change, nonrelapse mortality, or recurrent malignancy.|Up to 48 weeks|Participants in the ITT Analysis Set with available data were analyzed.|||Days||95% Confidence Interval|Median
2557883|NCT02701634|Secondary|Percentage of Participants Who Initiate Second-Line Therapy for cGVHD|Second-line therapy for cGVHD was defined as receiving any therapy besides systemic corticosteroids or study drug for the treatment of cGVHD. Inhaled and topical steroids are not considered second-line therapy.|Up to 48 weeks|ITT Analysis Set|||Percentage of participants|||Number
2557884|NCT02701634|Secondary|Percentage of Participants Who Achieve at Least 50% Reduction in Systemic Corticosteroid Dose Relative to Baseline|The percentage reduction was calculated as (systemic corticosteroid dose post baseline - baseline systemic corticosteroid dose) / baseline systemic corticosteroid dose.|Baseline; Up to 48 weeks|ITT Analysis Set|||Percentage of participants|||Number
2557885|NCT02701634|Secondary|Duration of Response|Duration of response was defined as the time from the documentation of best overall response rate to the documentation of progressive disease. Note that flare was not considered as progressive disease in this analysis.|Up to 48 weeks|ITT Analysis Set|||weeks||95% Confidence Interval|Median
2557886|NCT02701634|Secondary|Change From Baseline in the Total Score of the LSS at 24 Weeks|The LSS is a patient-reported questionnaire used to measure symptom burden. Each of the LSS subscales ranged between 0 and 100, with higher scores indicating more severe symptoms. The total score was calculated by taking the average of the subscale scores. A decrease from baseline value correlates with improvement in clinical outcome.|Baseline; Week 24|Participants in the ITT Analysis Set with available data were analyzed.|||score on a scale||Standard Deviation|Mean
2557887|NCT02701634|Secondary|Change From Baseline in the Eyes Domain of the LSS at 24 Weeks|The LSS is a patient-reported questionnaire used to measure symptom burden. Each of the LSS subscales ranged between 0 and 100, with higher scores indicating more severe symptoms. A decrease from baseline value correlates with improvement in clinical outcome.|Baseline; Week 24|Participants in the ITT Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2557888|NCT02701634|Secondary|Change From Baseline in the Mouth Domain of the LSS at 24 Weeks|The LSS is a patient-reported questionnaire used to measure symptom burden. Each of the LSS subscales ranged between 0 and 100, with higher scores indicating more severe symptoms. A decrease from baseline value correlates with improvement in clinical outcome.|Baseline; Week 24|Participants in the ITT Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2557889|NCT02701634|Secondary|Change From Baseline in the Skin Domain of the Lee Symptom Scale (LSS) at 24 Weeks|The LSS is a patient-reported questionnaire used to measure symptom burden. Each of the LSS subscales ranged between 0 and 100, with higher scores indicating more severe symptoms. A decrease from baseline value correlates with improvement in clinical outcome.|Baseline; Week 24|Participants in the ITT Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2557890|NCT02701634|Primary|Best Overall Response Rate|Best overall response rate by 24 weeks was defined as the proportion of participants who achieved a complete or partial overall response as assessed by the NIH cGVHD Activity Assessment (NCAA) within 24 weeks, in the setting of add-on therapy to systemic corticosteroids as part of first-line therapy for cGVHD.|Up to 24 weeks|ITT Analysis Set: all participants who were randomized into the study. Data was analyzed according to treatment randomized.|||Percentage of participants|||Number
2557891|NCT02701582|Other Pre-specified|Area Under Curve of MAP Below 65|Hypotension as measured by area under the curve of MAP less than 65.|1 Day||||mmHG x minutes||Standard Deviation|Mean
2557892|NCT02701582|Other Pre-specified|Number of Patients Treated for Hypotension With Phenylephrine Drip|The number of patients on a phenylephrine drip within 24 hours post-op.|1 day||||Participants|||Count of Participants
2557893|NCT02701582|Other Pre-specified|Patients Requiring Fluid Bolus for Management|Number of patients who received fluid boluses in the first 24 hours post-op|1 day||||Participants|||Count of Participants
2557894|NCT02701582|Other Pre-specified|Fluid Balance Measured by Inputs and Outputs (I/Os) of All Measurable Fluid in Peri-operative Period|Fluid balance measured by I/Os of all fluid in the peri-op period during the first 12 hours after the subject's surgery.|Baseline and 12 Hours|Data not collected. This outcome measure was not included by PI in reported results|||ml/kg||Standard Deviation|Mean
2557895|NCT02701582|Other Pre-specified|Organ Oxygenation as Measured by Arterial Blood Gas Values|Patient's organ oxygenation as measured by base deficit mEq/L, during the first 24 hours after surgery.|Baseline and 1 day||||mEq/L||Standard Deviation|Mean
2557896|NCT02701582|Other Pre-specified|Organ Oxygenation as Measured by Serum Lactate|Serum lactate levels, as measured in mmol/L, in patients during the first 24 hours after surgery.|Baseline and 24 Hours||||mmol/L||Standard Deviation|Mean
2557897|NCT02701582|Other Pre-specified|Pulmonary Status as Measured by the Number of Participants Who Require Supplemental Oxygen|We looked at the number of patients who required supplemental oxygen within the first 24 hours after surgery.|1 day||||Participants|||Count of Participants
2557898|NCT02701582|Secondary|Creatinine Change|Change in creatinine in the 72 hour post-op period (mg/dL)|Baseline and 72 hours||||mg/dL||Standard Deviation|Mean
2557899|NCT02701582|Primary|Number of ICU Stays Greater Than 1.5 Days|the sum of ICU stays greater than the 1.5 Days eligibility for discharge from hospital according to the surgeon, over the course of 20 Days|20 Days||||Number of ICU Stays greater that 1.5 Day||95% Confidence Interval|Number
2557900|NCT02701556|Primary|The Primary Safety Endpoint Was Statistical Non-inferiority With Respect to the Proportion of Eyes With Any Slit Lamp Findings Greater Than Grade 2 at Any Visit Between the Test and Control Solutions.|A non-inferiority upper bound of 0.05 (5%) was used to assess the difference (Test - Control) in proportions of slit lamp outcomes. Graded slit lamp findings for each eye were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding).|3 months||||Participants|||Count of Participants
2557901|NCT02701387|Primary|Implant Stability Quotient (ISQ) Value as a Measure of Implant Stability in Bone|"Implant Stability Quotient (ISQ) is a scale from 1 to 100, to quantify implant stability in bone (higher values mean higher stability). ISQ numerical values are generated by applying resonance frequency analysis (RFA) or sound waves through a specialized peg attached to the implant. Data were combined to reduce the number of intervals for analysis purposes. Data from intervals were combined as follows:~Tr0 = T0 (baseline) Tr1 = Average of follow-up week 1 (T1) and follow-up week 2 (T2) Tr2 = Average of follow-up week 3 (T3) and follow-up week 4 (T4) Tr3 = Average of follow-up week 5 (T5) and follow-up week 6 (T6) Tr4 = Average of follow-up week 7 (T7) and follow-up week 8 (T8)"|Baseline (T0) and weekly thereafter for 8 weeks (T1-T8)|Seven participants, each missing at least two posterior teeth in the same arch, were enrolled, resulting in 10 matched pairs for analysis. Outcome was assessed per implant, not per individual participant;|||units on a scale|implants|Standard Deviation|Mean
2557902|NCT02701361|Other Pre-specified|Usability Themes Developed From Semi-structured Participant Interviews|A usability measure. Open-ended feedback questions will be arranged in themes.|end of study|||||||
2557903|NCT02701361|Secondary|Change in the Avoidance Domain of the Brief COPE Scale|Coping skills were measured with the Brief COPE scale (range 10 [low use] to 40 [highest use]). The Brief COPE is a self-report questionnaire used to assess a number of different coping behaviors and thoughts a person may have in response to a specific situation.|Between randomization and 3 months post-randomization||||units on a scale||95% Confidence Interval|Mean
2557904|NCT02701361|Secondary|Change in Psychological Distress Symptoms as Measured by the PTSS|The Post Traumatic Stress Scale (PTSS), a 10-item scale (range 10 [no symptoms] to 70 [high burden of symptoms]), was used to assess PTSD symptoms; >20 represents clinically important symptoms.|Between randomization and 3 months post-randomization||||units on a scale||95% Confidence Interval|Mean
2557905|NCT02701361|Secondary|Change in Psychological Distress Symptoms as Measured by the GAD-7|Anxiety symptoms were measured using the Generalized Anxiety Disorder 7-item scale (GAD-7; range 0 [no distress] to 21 [high distress]); symptom severity is interpreted as mild (5-9), moderate (10-14), and severe (15-21).|Between randomization and 3 months post-randomization||||units on a scale||95% Confidence Interval|Mean
2557906|NCT02701361|Secondary|Change in Mindfulness Skills|Mindfulness skills were measured with the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R), a 12-item measure of mindful qualities (range 12 [low ability] to 48 [highest ability]).|Between randomization and 3 months post-randomization||||units on a scale||95% Confidence Interval|Mean
2557908|NCT02701361|Secondary|Change in Psychological Distress Symptoms as Measured by the Patient Health Questionnaire (PHQ) Scale|Depression symptoms were assessed with the PHQ-9, a 9-item scale (range 0 [no distress] to 27 [high distress]); symptom severity is interpreted as mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27).|Between randomization and 3 months post-randomization||||units on a scale||95% Confidence Interval|Mean
2557909|NCT02701361|Primary|Number of Participant Clicks on Study Website|A usability measure obtained using Google Analytics.|baseline, end of study (approx. 4 months)||||clicks||Standard Deviation|Mean
2557910|NCT02701361|Primary|Visual Analog Satisfaction Scale|A measure of acceptability of the intervention. Target mean score is 75% or greater.|after intervention completion, up to 8 weeks post-randomization|measure was mistakenly omitted from study CRF and therefore data not collected.||||||
2557911|NCT02701361|Primary|Percentage of Self-directed MBT Sessions Attended by Eligible Participants|A feasibility measure. Target is 50% among those who neither dropped out nor died.|baseline, end of study (approx. 4 months)||||Participants|||Count of Participants
2557912|NCT02701361|Primary|Percent of Participants in the Self-directed MBT Group Who Complete Weekly Surveys|A feasibility measure. Target is 60%. Note that this is for completion of ALL FOUR weekly surveys.|baseline, end of study (approx. 4 months)||||Participants|||Count of Participants
2557913|NCT02701361|Primary|Percent of Participants Who Have Neither Dropped Out Nor Died Who Complete Telephone Interviews|Percent of participants who have neither dropped out nor died who complete telephone interviews. A feasibility measure. Target is 75%.|baseline, end of study (approx. 4 months)||||Participants|||Count of Participants
2557914|NCT02701361|Primary|Percent of Randomized Participants Who Drop Out of Study|A feasibility measure. Target is 20% or less.|baseline, end of study (approx. 4 months)||||Participants|||Count of Participants
2557915|NCT02701361|Primary|System Usability Scale (SUS)|Usability of the mobile app was assessed with open-ended participant feedback and with the 10-item System Usability Scale (SUS; 0 [lowest] to 100 [highest]). A SUS score above a 68 would be considered above average and anything below 68 is below average.|1 month post-randomization||||units on a scale||Standard Deviation|Median
2557916|NCT02701361|Primary|Client Satisfaction Questionnaire (CSQ) Score|Acceptability was measured with the adapted Client Satisfaction Questionnaire (CSQ), which assesses credibility and satisfaction (range 9 [low, a worse outcome] to 36 [highest, a better outcome]). Target is mean score >10.|1 month post-randomization||||units on a scale||Standard Deviation|Mean
2557917|NCT02701361|Primary|Percent of Eligible Participants Who Provide Informed Consent and Were Randomized|Percent of eligible participants who provide informed consent and were randomized. A measure of feasibility. Target is 60%.|randomization|Following consent, two participants were found to be ineligible.|||Participants|||Count of Participants
2557918|NCT02701361|Primary|Percent of Eligible Participants Who Provided Consent|Percent of eligible participants who provided consent. Because this includes eligible yet not-as-yet randomized participants, there are no study arm differences analyzed. This is a feasibility measure. Target is 70%.|pre-randomization|121, not 90 subjects, are analyzed because this outcome measure applies to a pre-consent and pre-randomization time period.|||Participants|||Count of Participants
2557919|NCT02701296|Secondary|Sensation in the Peroneal Nerve Distribution|Number of participants with self reported on a 3-point scale; 0=normal (No Sensory Block), 1= absent cold perception but touch sensation in tact (Partial Sensory Block), 2= absence of touch sensation (Complete Sensory Block)|Upon emergence from anesthesia in the PACU||||Participants|||Count of Participants
2557920|NCT02701296|Secondary|Dorsiflexion in the Peroneal Nerve Distribution|Number of participants with a blinded nurse assessment on a 3-point scale 0= normal (No Motor Block), 1= weak (Partial Motor Block), 2 = absent (Complete Motor Block)|Upon emergence from anesthesia in the PACU||||Participants|||Count of Participants
2557921|NCT02701296|Secondary|Cold Sensation in the Tibial Nerve Distribution|Number of participants with a self reported on a 3-point scale; 0=normal (No Sensory Block), 1= absent cold perception but touch sensation in tact (Partial Sensory Block), 2= absence of touch sensation (Complete Sensory Block)|Upon emergence from anesthesia in the PACU||||Participants|||Count of Participants
2557922|NCT02701296|Secondary|Plantar Flexion in the Tibial Nerve Distribution|Blinded nurse assessment on a 3-point scale 0= normal (No Motor Block), 1= weak (Partial Motor Block), 2 = absent (Complete Motor Block)|Upon emergence from anesthesia in the PACU||||Participants|||Count of Participants
2557923|NCT02701296|Secondary|Opioid Consumption|Amount of opioid used for the first 24 hours post surgery|24 hours post surgery|Mean consumption of Hydromorphone(mg) post-op day 1|||mg||Standard Deviation|Mean
2557924|NCT02701296|Primary|Pain Intensity|Mean Numeric Pain Rating Scale (NPRS) self-reported pain Intensity on a 11-point score (0=no pain to 10= worst possible) in Post Anesthesia Care Unit (PACU) and every 6 hours for 48 hours post surgery|48 hours post surgery||||pain score||Standard Deviation|Mean
2557925|NCT02701270|Secondary|Assessment of IAUC (Incremental Area Under the Curve) in Blood Insulin Response||0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose|Participants from whom full set of blood insulin measurements were available.|||min*mmol/L||Standard Deviation|Mean
2557926|NCT02701270|Primary|Assessment of IAUC (Incremental Area Under the Curve) in Blood Glucose Response||0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 minutes post dose|Participants from whom full set of blood glucose measurements were available.|||min*mmol/L||Standard Deviation|Mean
2557927|NCT02701257|Secondary|PG AUC in the 3.5 Hours Following the Meal|This applies only to the infusion set sub-study|3.5 hours following the meal|This outcome only applies to the infusion set sub study, the other arms were not analyzed. The Overall Number of Participants Analyzed represents all Completed participants that received the intervention|||mg*min/dl||Standard Deviation|Mean
2557928|NCT02701257|Secondary|Difference in the PG Prior to the Meal and Peak Post-prandial Glucose|This applies only to the infusion set sub-study|Pre-meal PG value and peak PG value during the 3.5 hours following the meal.|This outcome only applies to the infusion set sub study, the other arms were not analyzed. The Overall Number of Participants Analyzed represents all Completed participants that received the intervention|||mg/dl||Standard Deviation|Mean
2558805|NCT02688842|Secondary|Participants With Target Lesion Failure|a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)|30 days after stent implantation||||Participants|||Count of Participants
2557929|NCT02701257|Secondary|Difference Between the Fasted PG Value and the PG Value at 90 Minutes|This applies only to the infusion set sub-study|Baseline Fasted State and 90 Minutes|This outcome only applies to the infusion set sub study, the other arms were not analyzed. The Overall Number of Participants Analyzed represents all Completed participants that received the intervention|||mg/dl||Standard Deviation|Mean
2557930|NCT02701257|Secondary|Terminal Half Life After the Insulin Dose|This applies only to the infusion set sub-study|8 hours|This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.||||||
2557931|NCT02701257|Secondary|AUC in the First 90 Minutes After the Insulin Dose|This applies only to the infusion set sub-study|8 hours|This outcome only applies to the infusion set sub study, the other arms were not analyzed.The infusion set sub study was terminated and the insulin assays were not completed.||||||
2557932|NCT02701257|Secondary|AUC in the First 60 Minutes After the Insulin Dose|This applies only to the infusion set sub-study|8 hours|This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.||||||
2557933|NCT02701257|Secondary|AUC in the First 30 Minutes After the Insulin Dose|This applies only to the infusion set sub-study|8 hours|This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.||||||
2557934|NCT02701257|Secondary|C Max After the Insulin Dose|This applies only to the infusion set sub-study|8 hours|This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.||||||
2557935|NCT02701257|Secondary|T 1/2 Max After the Insulin Dose|This applies only to the infusion set sub-study|8 hours|This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.||||||
2557936|NCT02701257|Secondary|Tmax After the Insulin Dose|This applies only to the infusion set sub-study|8 hours|This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.||||||
2557937|NCT02701257|Secondary|Difference Between Insulin Levels at Baseline and at 90 Minutes|This applies only to the infusion set sub-study|8 hours|This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.||||||
2557938|NCT02701257|Secondary|Mean Insulin Levels During the Initial 90 Minute Fasted Period|This applies only to the infusion set sub-study|8 hours|This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.||||||
2557939|NCT02701257|Secondary|Insulin Area Under the Curve During the Initial 90 Minute Fasted Period|This applies only to the infusion set sub-study|8 hours|This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.||||||
2557940|NCT02701257|Secondary|Number of Unscheduled CGM Sensor Changes.|This applies only to the iPhone vs. iLet BP experiments|8 hours|This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.|||number of sensor changes|||Number
2557941|NCT02701257|Secondary|Number of Unscheduled Infusion Set Replacements.|This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments.|8 hours|The experimental arm with the iLet BP using Xeris glucagon was never conducted. Analysis includes 9 subjects that completed both the BP visits and 4 subjects that completed both infusion set sub study visits.|||number of infusion set changes|||Number
2557942|NCT02701257|Secondary|Difference in Local Erythema and Edema According to the Draize Scale|This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments. The draize scale assess erythema, eschar and edema using a score from 0-4, with 4 meaning a worse outcome.|8 hours|The experimental arm with the iLet BP using Xeris glucagon was never conducted. Analysis includes 9 subjects that completed both the BP visits and 4 subjects that completed both infusion set sub study visits.|||score on a scale||Standard Deviation|Mean
2557943|NCT02701257|Secondary|Average Insulin Infusion Site Pain From VAS|"This applies to the iPhone vs. iLet BP experiments and the infusion set sub-study experiments. Subjects were given a visual analog scale measuring 100 mm and asked to draw a line to indicate their level of pain at timepoints during the study with 100 being the worst possible pain and 0 being no pain."|8 hours|The experimental arm with the iLet BP using Xeris glucagon was never conducted. Analysis includes 9 subjects that completed both the BP visits and 4 subjects that completed both infusion set sub study visits.|||score on a scale||Standard Deviation|Mean
2557944|NCT02701257|Secondary|Difference in Mean Nausea From VAS During the Study|"This applies only the iPhone vs. iLet BP experiments. Subjects were given a visual analog scale measuring 100 mm and asked to draw a line to indicate their level of nausea at timepoints during the study with 100 being the worst possible nausea and 0 being no nausea."|8 hours|This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.|||score on a scale||Standard Deviation|Mean
2557945|NCT02701257|Secondary|Total Grams of Carbohydrate Taken for Hypoglycemia.|The total grams of carbohydrates given to subjects for treatment of hypoglycemia. This applies only to the iPhone vs iLet BP experiments.|8 hours|This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.|||number of grams of carbohydrates|||Number
2558358|NCT02695290|Secondary|Time to First Dose Reduction of Afatinib Caused by Adverse Events (AEs)|Time to first dose reduction of afatinib caused by Adverse Events (AEs) defined as time from the date of the first administration of afatinib to the first dose reduction of afatinib caused by AEs.|Up to 98 days|All data collected from the single patient who received study medication. As none of the AEs led to the dose reduction hence time to first dose reduction is not applicable.||||||
2557946|NCT02701257|Secondary|Number of Episodes of Symptomatic Hypoglycemia.|Number of time subjects experienced symptoms of hypoglycemia and reported that to study staff. This applies only to the iPhone vs iLet BP experiments.|8 hours|This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.|||number of episodes|||Number
2557947|NCT02701257|Secondary|Insulin Total Delivery Per kg of Body Mass.|The average total insulin delivered by the bionic pancreas. This applies only to the iPhone vs iLet BP experiments.|8 hours|This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.|||units/kg||Standard Deviation|Mean
2557948|NCT02701257|Secondary|Glucagon Total Delivery Per kg of Body Mass.|The average total glucagon delivered by the bionic pancreas. This applies only to the iPhone vs iLet BP experiments.|8 hours|This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.|||mcg/kg||Standard Deviation|Mean
2557949|NCT02701257|Secondary|CGM Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM.|A measure of CGM reliability, indicating the percentage of values the CGM displayed out of the total values it should have displayed in that time. This applies only to the iPhone vs iLet BP experiments.|8 hours|This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted.|||percentage of CGM values||Standard Deviation|Mean
2557950|NCT02701257|Secondary|Average Percent of 5 Minute Steps During Which the Bionic Pancreas is Functioning Nominally With or Without a New CGM Glucose Reading Captured (Dose Calculated, Dose Issued to Pumps).|"The percentage of time (measured in 5 minute steps) that the bionic pancreas is working even without a CGM reading being present, indicated by a successful dose calculation and successful issuing of a dose. This applies only to the iPhone vs iLet BP experiments."|8 hours|This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted.|||percentage of 5 minutes steps||Standard Deviation|Mean
2557951|NCT02701257|Secondary|Average Percent of 5 Minute Steps During Which the Bionic Pancreas is Functioning Nominally in All Respects Based on Real-time CGM Data (New CGM Glucose Reading Captured, Dose Calculated, Dose Issued to Pumps|"The percentage of time (measured in 5 minute steps) that the bionic pancreas is working, indicated by the presence of a CGM reading, a successful dose calculation and successful issuing of a dose. This applies only to the iPhone vs iLet BP experiments."|8 hours|This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted.|||percentage of 5 minute steps||Standard Deviation|Mean
2557952|NCT02701257|Secondary|Average Percent Glucagon Dose Amounts Successfully Issued to the Pump by the Bionic Pancreas Control Algorithm That a Successfully Delivered by the Pump.|The average percentage of successfully issued glucagon doses that are then delivered successfully by the pump. This applies only to the iPhone vs iLet BP experiments.|8 hours|This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.|||percentage of doses||Standard Deviation|Mean
2557953|NCT02701257|Secondary|Average Percent Insulin Dose Amounts Successfully Issued to the Pump by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.|The average percentage of successfully issued insulin doses that are then delivered successfully by the pump. This applies only to the iPhone vs iLet BP experiments.|8 hours|This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.|||percentage of doses||Standard Deviation|Mean
2557954|NCT02701257|Secondary|Average Percent Glucagon Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.|The average percentage of successfully delivered glucagon doses. This applies only to the iPhone vs iLet BP experiments.|8 hours|This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.|||percentage of doses||Standard Deviation|Mean
2557955|NCT02701257|Secondary|Average Percent Insulin Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump.|The average percentage of successfully delivered insulin doses. This applies only to the iPhone vs iLet BP experiments.|8 hours|This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.|||percentage of doses||Standard Deviation|Mean
2557956|NCT02701257|Secondary|Number of Severe Hypoglycemic Events (Subject Unable to Self-treat, Requiring the Assistance of Another Person)|The number of severe hypoglycemic events subjects experience. This applies only to the iPhone vs iLet BP experiments.|8 hours|This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.|||events|||Number
2557957|NCT02701257|Secondary|Number of Subjects With Mean CGM Glucose < 154 mg/dl|The number of subjects who achieved a mean CGM glucose < 154 mg/dl, which correlates to an estimated hemoglobin a1c of 7%, which is the ADA goal for therapy. This applies only to the iPhone vs iLet BP experiments|8 hours|This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.|||Participants|||Count of Participants
2557958|NCT02701257|Secondary|Percentage of Time in Each of the Following Ranges: < 50 mg/dl, < 60 mg/dl, <70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, >180 mg/dl, >250 mg/dl|Percentage of time subjects spent in each of these ranges based on continuous glucose monitor readings. This only applies to the iPhone vs iLet BP visits.|8 hours|This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.|||percentage of time||Standard Deviation|Mean
2557959|NCT02701257|Secondary|Average Continuous Glucose Monitor (CGM) Glucose|The average glucose according to continuous glucose monitor readings. This only applies to the iPhone vs. iLet BP experiments.|8 hours|This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.|||mg/dl||Standard Deviation|Mean
2557960|NCT02701257|Primary|Insulin Area Under the Curve in the 3.5 Hours Following the Insulin Bolus|This applies only to the infusion set sub-study|3.5 hours following insulin bolus|This outcome only applies to the infusion set sub study, the other arms were not analyzed. The infusion set sub study was terminated and the insulin assays were not completed.||||||
2557961|NCT02701257|Primary|Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Glucagon Doses).|Average percent dose amounts calculated by the bionic pancreas control algorithm that are successfully delivered by the pump (glucagon doses) - - primary outcome for iLet BP using Lilly glucagon vs. iLet BP using Xeris Xerisol glucagon|8 hours|This analysis only applies to the iLet BP using Lilly glucagon vs the iLet BP using Xerisol glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. Data for this outcome is reported for the iPhone BP and iLet BP arms using Lilly glucagon. This analysis does not apply to the infusion set sub study.|||percentage of doses||Standard Deviation|Mean
2557962|NCT02701257|Primary|Average Percent Dose Amounts Calculated by the Bionic Pancreas Control Algorithm That Are Successfully Delivered by the Pump (Aggregate of Both Insulin and Glucagon Doses)|Average percent dose amounts calculated by the bionic pancreas control algorithm that are successfully delivered by the pump (aggregate of both insulin and glucagon doses) - primary outcome for iPhone-based BP using Lilly glucagon vs. iLet BP using Lilly glucagon|8 hours|This analysis only applies to the iPhone BP vs iLet BP using Lilly glucagon arms. The experimental arm with the iLet BP using Xeris glucagon was never conducted. This analysis does not apply to the infusion set sub study. Analysis includes 9 subjects that completed both the BP visits.|||percentage of doses delivered||Standard Deviation|Mean
2557963|NCT02701049|Secondary|Proportion of Patients Reporting SO/GI|Measures the proportion of all adult emergency department patients from whom SO/GI was collected during the study period|Through study completion (approximately 1 year)|All adult patients who were seen in the ED during the intervention periods|||Participants|||Count of Participants
2557964|NCT02701049|Secondary|Staff-reported Outcomes Measure Questionnaire|"Measures responses to the staff survey question, Did you experience difficulty collecting sexual orientation data from patients?"|Through study completion (approximately 1 year)|Nurses and registrars who completed staff outcome surveys|||Participants|||Count of Participants
2557965|NCT02701049|Primary|Communication Climate Assessment Toolkit Questionnaire (Patient)|"The primary outcome was patient satisfaction as measured by a modified Communication Climate Assessment Toolkit (CCAT) patient survey, an assessment of attitudes towards organizational climate and provider/patient communication.The CCAT is reliable, validated in geographically and ethnically diverse health care organizations, and accurately predicts patient-reported quality and trust. Containing 5/7 items from the full CCAT, our pre-specified modified scale included only questions that were applicable to the ED population, e.g. we kept the question Do you feel welcome at the hospital? but eliminated the question Was it easy to reach someone on the phone if you had a question? from analyses.Each scale item was scored as a 0 (most disagreement), ½ (neutral), or 1 (agreement), resulting in a scale score ranging from 0-5; higher scores were considered more favorable. The average score for the modified scale was calculated and multiplied by 20 to provide the overall score out of 100."|Through study completion (approximately 1 year)|Patients who were not asked SO/GI or who provided their SO/GI in the ED via verbal or nonverbal collection and provided complete data on the patient outcome survey|||Score||Standard Deviation|Mean
2557966|NCT02700997|Primary|Suture Location in Relation to the Surrounding Anatomy|Measurement between internal iliac complex and proximal suture; measurement between ureter and proximal/distal suture.|1 day after surgery||||cm||Standard Deviation|Mean
2557967|NCT02700984|Secondary|Percentage of Subjects Not Using Ocular Hypotensive Medication With IOP ≥ 6 mmHg and ≤ 18 mmHg|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.|Month 36, 48, 60 postoperative|All subject eyes with data available at the visit|||percentage of subjects|||Number
2557968|NCT02700984|Secondary|Percentage of Subjects With ≥ 20% Reduction in IOP From Baseline (COMPASS Trial) Without the Use of Ocular Hypotensive Medications|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.|Baseline, Month 36, 48, 60 postoperative|All subject eyes for which data was available at the visit|||percentage of subjects|||Number
2557969|NCT02700984|Secondary|Mean Reduction From Baseline in Intraocular Pressure (IOP)|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A higher reduction from baseline (ie, a greater postitive number) indicates greater improvement. Baseline was derived from COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.|Baseline, Month 36, 48, 60 postoperative|All subject eyes for which data was available at the visit|||mmHg||Standard Deviation|Mean
2560869|NCT02658240|Primary|Postoperative Pain Score at Resting|The Visual Analog Pain Score (VAS) at resting on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively|Postoperative 48 hours||||units on a scale||Inter-Quartile Range|Median
2557970|NCT02700984|Secondary|Number of Subjects With CyPass Device Malposition, Dislodgement or Movement|Device position was a qualitative and subjective assessment by the investigator and evaluated based on visible number of rings of the device under the gonioscopic exam. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint. This outcome measure was prespecified for Cataract Surgery + CyPass arm only.|Up to 60 months postoperatively|Total number of subjects in the treatment group|||subjects|||Number
2557971|NCT02700984|Secondary|Central Corneal Endothelial Cell Density (ECD) by Visit|The endothelium maintains corneal hydration and reduced cell density can disrupt vision. Central endothelial cell counts were assessed using non-contact specular microscopy. Specular images were taken of the corneal endothelium and submitted to a reading center in order to standardize readings across all sites and optimize reading reliability. Baseline through Month 24 data were derived from COMPASS trial. A higher cell density indicates improvement. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.|Baseline, Month 3, 6, 12, 24, 36, 48, 60 postoperative|All subject eyes for which data was available at the visit|||cells/mm2||Standard Deviation|Mean
2557972|NCT02700984|Secondary|Change From Month 24 in Central Corneal Thickness|Central corneal thickness was evaluated by Pachymetry and measured in micrometers (μm). A negative number indicates a decrease in corneal thickness (unfavorable). Month 24 data derived from COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.|Month 24, 36, 48, 60 postoperative|Subject eyes for which data was available at the visit|||micrometers||Standard Deviation|Mean
2557973|NCT02700984|Secondary|Change From Month 24 in Visual Field Mean Deviation|Visual field (how much one can see to each side while focusing the eyes on a central point (peripheral vision)) deviations were obtained with a Humphrey automated perimeter using the 24-2 SITA standard testing method. Normal deviation values are typically within 0 to -2 decibels (dB) and become more negative as the overall field worsens. Month 24 data derived from COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.|Month 24, 36, 48, 60 postoperative|All subject eyes for which data was available at the visit|||dB||Standard Deviation|Mean
2557974|NCT02700984|Secondary|Number of Subjects With Clinically Significant Findings Noted During Fundus Examinations|The dilated fundus examination was performed by the investigator to evaluate the health of the vitreous, retina, macula, choroid, and optic nerve. Clinically significant findings are reported categorically. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.|Month 36, 48, 60 postoperative|Subjects with available data at each visit|||subjects|||Number
2557975|NCT02700984|Secondary|Gonioscopy at Visits 36, 48, and 60, CyPass Subjects Only|For subjects in the CyPass group, gonioscopic examination was performed to assess the position of the CyPass Micro-Stent in the angle and with respect to the iris and the corneal endothelium. A visible CyPass Micro-Stent indicated a lack of adhesions (favorable). One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.|Month 36, 48, 60 postoperative|Number of eyes with available data and CyPass not explanted before visit|||eyes|eyes||Number
2557976|NCT02700984|Secondary|Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Posterior Capsule Opacification (PCO) Severity|PCO (cloudy layer of scar tissue behind the lens implant) Severity was assessed by the investigator during slit-lamp examination and rated on a 6-point scale: None, Minimal, Mild, Moderate, Severe, and Unspecified. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.|Month 36, 48, 60 postoperative|All subjects with available data at that visit|||subjects|||Number
2557977|NCT02700984|Secondary|Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Rubeosis|Iris Rubeosis (abnormal blood vessels (formed by neovascularization) found on the surface of the iris) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None, Mild, Moderate, and Severe. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.|Month 36, 48, 60 postoperative|All subjects with available data at that visit|||subjects|||Number
2557978|NCT02700984|Secondary|Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Peaking|Iris Peaking (one part of the iris pulled to a peak resulting in an irregular pupil) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None, Mild, Moderate, and Severe. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.|Month 36, 48, 60 postoperative|All subjects with available data at that visit|||subjects|||Number
2557979|NCT02700984|Secondary|Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Iris Atrophy/Erosion|Iris Atrophy/Erosion (deterioration) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None, Mild, Moderate, and Severe. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.|Month 36, 48, 60 postoperative|All subjects with available data at that visit|||subjects|||Number
2557980|NCT02700984|Secondary|Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Flare|Anterior Chamber Flare (protein escaping from dilated vessels) was assessed by the investigator during slit-lamp examination and rated on a 5-point scale: None, Faint, Moderate (iris and lens details clear), Marked (iris and lens details hazy), and Intense (fibrin or plastic aqueous). The presence of flare is a sign of intraocular inflammation. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.|Month 36, 48, 60 postoperative|All subjects with available data at that visit|||subjects|||Number
2557981|NCT02700984|Secondary|Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Anterior Chamber Cells|Inflammatory anterior chamber cells (cells in the front portion of the eye) were assessed by the investigator during slit-lamp examination and reported in one of 6 categories according to cells per 1x1 mm slit: 0-<1 cell, 1-5 cells, 6-15 cells, 16-25 cells, and 26-50 cells, and >50 cells. Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.|Month 36, 48, 60 postoperative|All subjects with available data at that visit|||subjects|||Number
2557982|NCT02700984|Secondary|Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Staining/Erosion|Corneal Staining (appearance of tissue disruption and other pathophysiological changes) and erosion (abrasion) were assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None (no fluorescein staining of epithelium, OR less than mild), Mild (slight fluorescein staining confined to a small focus), Moderate (regionally dense fluorescein staining (1 mm or greater in diameter) with underlying structure moderately visible), and Severe (marked fluorescein staining or epithelial loss). Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.|Month 36, 48, 60 postoperative|All subjects with available data at that visit|||subjects|||Number
2557983|NCT02700984|Secondary|Slit-lamp Examination Results at Visits 36, 48, and 60, by Treatment Group - Corneal Edema|Corneal Edema (swelling of the cornea) was assessed by the investigator during slit-lamp examination and rated on a 4-point scale: None (transparent and clear or less than mild), Mild (dull glassy appearance), Moderate (Dull glassy appearance of epithelium with large number of vacuoles), and Severe (epithelial bullae and/or stromal edema, localized or diffuse, with or without stromal striae). Only the categories with reported data are included. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.|Month 36, 48, 60 postoperative|All subjects with available data at that visit|||subjects|||Number
2557984|NCT02700984|Secondary|Number of Subjects Who Reported at Least One Protocol-specified Ocular Adverse Event in the Study Eye|Ocular adverse events in the study eye could include, but were not limited to, BCVA loss of 2 lines (10 letters) or more on the ETDRS chart in comparison with the best BCVA reported in Study Protocol TMI-09-01, endophthalmitis, corneal edema, and corneal decompensation. Inferential testing was not planned for this endpoint.|Up to Month 60 postoperative|All enrolled subjects|||Subjects|||Number
2557985|NCT02700984|Secondary|Number of Subjects According to Best Corrected Visual Acuity (BCVA) by Visit|Best corrected (with spectacles or other visual corrective devices) VA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 1 or 4 meters and determined by total number of letters read correctly. 20/20 Snellen is considered 'normal' vision. A larger denominator indicates a lower visual acuity. Baseline, Month 12, and Month 24 data derived from previous COMPASS trial. One eye (study eye) contributed to the analysis. Inferential testing was not planned for this endpoint.|Baseline, Month 12, 24, 36, 48, 60 postoperative|All enrolled subjects with available data|||subjects|||Number
2557986|NCT02700984|Primary|5-year Annualized Rate (Percentage) of Sight-threatening Adverse Events, by Treatment Group|Sight-threatening adverse events occurring in the study eye included, but were not limited to: BCVA loss of ≥ 3 lines, endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment and aqueous misdirection. The number of events at the end of Year 5 was divided by the number of eyes at risk at the beginning of Year 1 for a 5-year annualized rate. The 5-year annualized rate is reported as a percentage, with the last annual non-censored rate divided by 5. Inferential testing was not planned for this endpoint.|Up to Month 60 postoperative|All enrolled subjects with available data|||rate (percentage) of adverse events|eyes|95% Confidence Interval|Number
2557987|NCT02700815|Secondary|Change From Baseline in Pressure Algometry (PA) at Day 6 Morning|PA is a method described to determine pressure pain threshold (PPT) by applying controlled pressure to a given body point. The results presented here are adjusted mean change from baseline and standard error for PA.|Baseline and Day 6|TS|||Newton/centimeter square (N/cm^2)||Standard Error|Least Squares Mean
2557988|NCT02700815|Secondary|Change From Baseline in Pressure Algometry (PA) at Day 2 Evening, Before Drug Application|PA is a method described to determine pressure pain threshold (PPT) by applying controlled pressure to a given body point. The results presented here are adjusted mean change from baseline and standard error for PA.|Baseline and Day 2|TS|||Newton/centimeter square (N/cm^2)||Standard Error|Least Squares Mean
2557989|NCT02700815|Secondary|Change From Baseline in POMwp (cm) at Day 6 Morning|Pain on movement (POM) was used to assess pain measurement for back and neck pain. The standardized movements have been established for which the measurement was taken. POMwp was the POM measure that gave the highest score at baseline; i.e. POM of worst procedure. Pain intensity was assessed at rest after standing in an upright position relatively motionless for 1 minute. The pain was evaluated by asking patient 'How would you rate your pain right now?' and by using a visual analogue scale (VAS) ranging from 0-10 cm wherein 0 cm = no pain to 10 cm = worst pain possible. The results presented here are adjusted mean change from baseline and standard error for POMwp in centimeters (cm).|Baseline and Day 6|TS|||Units on a scale||Standard Error|Least Squares Mean
2557990|NCT02700815|Secondary|Number of Patients With Decrease in POMwp of at Least 50% From Baseline|This outcome measures the pattern of number of patients with a decrease in POMwp of at least 50% from baseline at 1 hour after dosing on Day 2 evening.|Baseline and day 2|TS|||Participants|||Number
2557991|NCT02700815|Secondary|Number of Patients With Decrease in POMwp of at Least 30% From Baseline|This outcome measures the pattern of number of patients with a decrease in POMwp of at least 30% from baseline at 1 hour after dosing on Day 2 evening.|Baseline and day 2|TS|||Participants|||Number
2557992|NCT02700815|Secondary|POMwp Area Under the Curve (AUC) Calculated From 0 to 120 Hours (h) (POMwp AUC(0-120 h))|This is a key secondary endpoint. AUC for POMwp calculated from 0 to 120 h that is for first five treatment days using the trapezoidal rule divided by the observation time. The results presented here are adjusted mean and standard error for POMwp AUC (0-120 h) in centimeters (cm). The AUC represents POMwp as an average over the first 5 treatment days (Day 1 until Day 6 morning) - it is not meant here as a PK parameter (concentration over time).|0 to 120 hours after start of treatment|TS|||cm||Standard Error|Least Squares Mean
2557993|NCT02700815|Secondary|POMwp Area Under the Curve (AUC) Calculated From 0 to 72 Hours (h) (POMwp AUC(0-72 h))|This is a key secondary endpoint. AUC for POMwp calculated from 0 to 72 h that is for first three treatment days using the trapezoidal rule divided by the observation time. The results presented here are adjusted mean and standard error for POMwp AUC (0-72 h) in centimeters (cm). The AUC represents POMwp as an average over the first 3 treatment days (Day 1 until Day 4 morning) - it is not meant here as a pharmacokinetics (PK) parameter (concentration over time).|0 to 72 hours after start of treatment|Treated set (TS)|||cm||Standard Error|Least Squares Mean
2560870|NCT02658149|Secondary|Opioid Usage In-hospital at 48 Hours|Total amount of opioids used per patient (measured with Morphine Equivalent Units)|48 hours postoperatively||||Morphine Equivalent Units (Oral)||Standard Deviation|Mean
2557994|NCT02700815|Primary|Change in POM Between Baseline and Day 2 Evening, 1 Hour After Drug Application|Pain on movement (POM) was used to assess pain measurement for back and neck pain. The standardized movements have been established for which the measurement was taken. POMwp was the POM measure that gave the highest score at baseline; i.e. POM of worst procedure. Pain intensity was assessed at rest after standing in an upright position relatively motionless for 1 minute. The pain was evaluated by asking patient 'How would you rate your pain right now?' and by using a visual analogue scale (VAS) ranging from 0-10 centimeters (cm) wherein 0 cm = no pain to 10 cm = worst pain possible. The results presented here are adjusted mean change from baseline and standard error for POMwp in cm.|Baseline and Day 2|Full analysis set (FAS): All patients in treated set with a baseline value pre application for POMwp at Visit 1 and at least 1 POMwp value during assessment times at Visit 1 (Day 1 morning 1h after application), Visit 2 (Day 2, morning 1h after application), Visit 3 (Day 2 evening before application) or Visit 3 (Day 2 evening 1h after application)|||Units on a scale||Standard Error|Least Squares Mean
2557995|NCT02699983|Secondary|Social Support for Healthy Nutrition|change in social support for healthy nutrition, measured by Health Beliefs Survey, scale range 1 (strongly disagree) to 5 (strongly agree); a higher number, e.g., 5 (strongly agree) is the more favorable outcome|baseline and 6 months||||units on a scale||Standard Deviation|Mean
2557996|NCT02699983|Secondary|Social Support for Healthy Nutrition|change in social support for healthy nutrition, measured by Health Beliefs Survey, scale range 1 (strongly disagree) to 5 (strongly agree); a higher number, e.g., 5 (strongly agree) is the more favorable outcome|baseline and 3 months||||units on a scale||Standard Deviation|Mean
2557997|NCT02699983|Secondary|Self-efficacy, Eating Healthy Foods|change in self-efficacy, eating healthy foods, measured with Health Beliefs Survey, scale range 0 (certain I cannot) to 100 (certain I can)|baseline and 6 months||||units on a scale||Standard Deviation|Mean
2557998|NCT02699983|Secondary|Self-efficacy, Eating Healthy Foods|change in self-efficacy, eating healthy foods, measured with Health Beliefs Survey, scale range 0 (certain I cannot) to 100 (certain I can)|baseline and 3 months||||units on a scale||Standard Deviation|Mean
2557999|NCT02699983|Secondary|Change in Quality of Life|measured using Quality of Life in Adult Cancer Survivors Scale (minimum 65, maximum 257); higher scores mean worse quality of life|baseline and 6 months||||units on a scale||Standard Deviation|Mean
2558000|NCT02699983|Secondary|Change in Quality of Life|measured using Quality of Life in Adult Cancer Survivors Scale (minimum 65, maximum 257); higher scores mean worse quality of life|baseline and 3 months||||units on a scale||Standard Deviation|Mean
2558001|NCT02699983|Secondary|Cardiopulmonary Fitness|change in fitness, measured by the 6-minute walk test|baseline and 6 months||||meters||Standard Deviation|Mean
2558002|NCT02699983|Secondary|Cardiopulmonary Fitness|change in fitness, measured by the 6-minute walk test|baseline and 3 months||||meters||Standard Deviation|Mean
2558003|NCT02699983|Secondary|Change in Physical Activity|change in average number of steps per day measured using Fitbit monitor|baseline and 6 months||||steps per day||Standard Deviation|Mean
2558004|NCT02699983|Secondary|Change in Physical Activity|change in average number of steps per day measured using Fitbit monitor|baseline and 3 months||||steps per day||Standard Deviation|Mean
2558005|NCT02699983|Secondary|Change in Caloric Intake|Changes in caloric intake per day, measured by 24-hour recall|baseline and 6 months||||kcal/day||Standard Deviation|Mean
2558006|NCT02699983|Secondary|Change in Caloric Intake|Changes in caloric intake per day, measured by 24-hour recall|baseline and 3 months||||kcal/day||Standard Deviation|Mean
2558007|NCT02699983|Secondary|Change in Waist Circumference|Change in waist circumference from baseline|baseline and 6 months||||cm||Standard Deviation|Mean
2558008|NCT02699983|Secondary|Change in Waist Circumference|Change in waist circumference from baseline|baseline and 3 months||||cm||Standard Deviation|Mean
2558009|NCT02699983|Secondary|Change in Weight|Change in weight from baseline|baseline and 6 months||||kg||Standard Deviation|Mean
2558010|NCT02699983|Secondary|Change in Weight|Change in weight from baseline|baseline and 3 months||||kg||Standard Deviation|Mean
2558011|NCT02699983|Primary|Acceptability of Fitbit|Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale|4-6 months after intervention||||score on a scale||Standard Deviation|Mean
2558012|NCT02699983|Primary|Acceptability of Fitbit|Usefulness of Fitbit, rated on 1 (not useful at all) to 4 (very useful) scale|0-3 months after intervention||||score on a scale||Standard Deviation|Mean
2558013|NCT02699983|Primary|Adherence to Fitbit|average days used Fitbit per week|4-6 months after intervention||||days/week||Standard Deviation|Mean
2558014|NCT02699983|Primary|Adherence to Fitbit|average days used Fitbit per week|0-3 months after intervention||||days/week||Standard Deviation|Mean
2558015|NCT02699983|Primary|Acceptability of SparkPeople|Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale|4-6 months after intervention||||score on a scale||Standard Deviation|Mean
2558016|NCT02699983|Primary|Acceptability of SparkPeople|Usefulness of SparkPeople website on 1 (not useful at all) to 4 (very useful) scale|0-3 months after intervention||||score on a scale||Standard Deviation|Mean
2558017|NCT02699983|Primary|Adherence to SparkPeople- Logged Food|Average number of days per week logged food into SparkPeople|4-6 months after intervention||||days/week||Standard Deviation|Mean
2558018|NCT02699983|Primary|Adherence to SparkPeople- Logged Food|Average number of days per week logged food into SparkPeople|0-3 months after intervention||||days/week||Standard Deviation|Mean
2558019|NCT02699983|Primary|Adherence to SparkPeople- Logged in|Average number of days per week logged in to SparkPeople website|4-6 months after intervention||||days/week||Standard Deviation|Mean
2558020|NCT02699983|Primary|Adherence to SparkPeople- Logged in|average number of days logged per week in to SparkPeople website|0-3 months after intervention||||days/week||Standard Deviation|Mean
2558021|NCT02699983|Primary|Retention Rate|Number of participants completing study. Feasibility will be defined as >= 80% retention rate.|6 months||||Participants|||Count of Participants
2558022|NCT02699983|Primary|Recruitment Rate|Number of eligible participants who were enrolled and randomly assigned. Feasibility is defined as >= 75% recruitment rate.|12 months|The overall number of participants is the number that were eligible for the study, hence it is greater than the number with results.|||Participants|||Count of Participants
2558023|NCT02699970|Primary|Agreement Rate|The agreement rate between reads calculated over all selected features and pathologists. Readings were considered in agreement when the selected feature was indicated as 'present' or 'absent' in both readings.|2 months|"For the intra-system sub-study 2 cases were not analyzed for possible reading bias due to an error in the EDC system.~For the inter-system sub-study 3 cases were not analyzed for different reasons such as possible reading bias due to an error in the EDC system (2) and a short washout period (1)."|||percentage of agreement|features|95% Confidence Interval|Mean
2558024|NCT02699892|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Good Response|Clinical response was assessed according to EULAR categorical DAS28 response criteria, which defined clinically meaningful improvement at Weeks 24, 48, and 72. EULAR response was based on change from baseline (CFB) in DAS28 score and on actual DAS28 score, at Weeks 24, 48, and 72. DAS28 score: participant's disease activity calculated using TJC28, SJC28, PGH [VAS: 0=no disease activity to 100=maximum disease activity] and ESR. DAS28 was calculated by following formula: (0.56*√TJC)+(0.28*√SJC)+(0.70*ln ESR)+(0.014*PGH). Total possible score = 0-10, higher scores represented higher disease activity. EULAR Good response: DAS28</=3.2; reduction of DAS28 >1.2.|Baseline, Weeks 24, 48 and 72|"ITT Population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and “n” signified those participants who were evaluable for a specified time point."|||Percentage of participants|||Number
2558025|NCT02699892|Primary|Percentage of Participants Achieving Reduction From Baseline in Disease Activity Score Based on 28 Joints Count (DAS28) of More Than 1.2 Units After 24 Weeks of First Rituximab Infusion|DAS28 score is a measure of participant's disease activity calculated using tender joint count [28 joints] (TJC28), swollen joint count [28 joints] (SJC28), participant's global assessment of disease activity (PGH) [visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity] and erythrocyte sedimentation rate (ESR). DAS28 was calculated according to following formula: [0.56 multiplied by (*) square root (√) of TJC] plus (+) [0.28*√SJC]+[0.70*the natural logarithm (ln) ESR]+[0.014*PGH]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of less than or equals to (</=) 3.2 indicated low disease activity, score of greater than (>) 3.2 to </=5.1 indicated moderate disease activity, scores above 5.1 indicated high or severe disease.|Baseline, 24 weeks after first rituximab infusion (Week 24)|"ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome."|||Percentage of participants|||Number
2558026|NCT02699684|Secondary|Change From Insertion in Minimum Protected Area (MPA)|MPA (the minimum area of the contact lens surface (expressed in %) protected by the tear film between two natural blinks) was assessed by the Investigator during the interblink period using the Tearscope® lighting system. Higher values indicate a more stable tear film in front of the lens. This Outcome Measure was pre-specified for AOHG only. Both eyes contributed to the analysis.|Hour 0 (Lens Insertion) to Hour 12 on Day 1|Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.|||percentage of contact lens surface area|Eyes|Standard Deviation|Mean
2558027|NCT02699684|Secondary|Mean Ex Vivo Total Cholesterol Uptake After 30 Days of Wear|The contact lens was removed from the eye. Cholesterol deposits were extracted and measured in micrograms (μg) per lens. Lower deposits indicate increased lens performance. Only one eye (right eye) contributed to the analysis.|Day 30, each product|Full Analysis Set. Only the right (OD) lenses were collected from a subset of subjects.|||μg||Standard Deviation|Mean
2558028|NCT02699684|Primary|"Percentage of Subjects Satisfying the no Re-fit Criteria in Both Eyes"|Overall lens fit was graded by the Investigator on a 5-point scale: -2 (unacceptably tight); -1 (acceptably tight); 0 (optimal fit); +1 (acceptable loose); +2 (unacceptable loose). 'No re-fit' criteria was satisfied if an acceptable or optimal overall lens fit, that was also within one grade of the habitual lens fit value, was achieved.|Day 30, each product|Full Analysis Set. Number Analyzed is the number of subjects with non-missing response.|||percentage of subjects|||Number
2558029|NCT02699632|Secondary|Concerns for Participating in Research While Pregnant|Survey question: What concerns might make you hesitant to participate in a research study while pregnant?|Day 1||||Participants|||Count of Participants
2558030|NCT02699632|Secondary|Comfort of Participating in Research While Pregnant|Survey question: Would you feel comfortable participating in a research study while pregnant?|Day 1||||Participants|||Count of Participants
2558031|NCT02699632|Secondary|Preferred Methods for Learning About a Research Study|Survey respondents were asked how they would prefer to learn about a research study with several answers cited.|Day 1||||Participants|||Count of Participants
2558032|NCT02699632|Primary|Willingness to Participate in Research While Pregnant|Survey question: What types of research would you be willing to participate in while you were pregnant?|Day 1|part 1 of question observational studies; part 2 of question retrospective studies; part 3 of question lifestyle interventions in pregnancy|||Participants|||Count of Participants
2558033|NCT02699593|Primary|Visual Acuity (LogMAR)|Distance Visual Acuity (LogMAR) was assessed using an ETDRS chart at the 2-week follow-up for each subject and eye for 2 conditions, Bright low contrast and Dim high contrast. The average visual acuity (LogMAR) for each condition and lens was reported.|2-week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||LogMAR|Eyes|Standard Deviation|Mean
2558034|NCT02699593|Primary|Contact Lens Wearing Time|Contact lens wearing time was collected for each subject at the 2-week follow-up evaluation. The average contact lens wearing time in hours was reported for each lens.|2-week follow-up|Subjects that completed all study visits without a major protocol deviation.|||Hours||Standard Deviation|Mean
2558035|NCT02699099|Secondary|Number of Subjects With Generalized Convulsive Seizure for All Study Groups, After Vaccines Administered at Day 0 and Month 1.5 (Coad and RTS,S Groups) and After Vaccines Administered at Month 3 (All Groups)|Generalized convulsive seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It is assessed by the investigator as specific to the treatment administration.|Within 7 days after vaccines administered at Day 0 and Month 1.5 for the Coad and RTS,S groups and 14 days after vaccines administered at Month 3 for all groups|Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.|||Participants|||Count of Participants
2558036|NCT02699099|Secondary|Number of Subjects With Seizures for Vaccine Doses Administered at 6, 7.5 and 27 Months of Age (Coad and RTS,S Group) and at 10.5, 11.5, 12.5 and 30 Months of Age (Control Group) or for Vaccine Doses Administered at 9 Months of Age (All Groups)|Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It was assessed by the investigator as specific to the treatment administration.|Within 30 days post-vaccine for doses administered at Day 0, Month 1.5, Month 21 for Coad and RTS,S Groups and at Month 4.5, Month 5.5, Month 6.5, Month 24 for Control Group or 42 days post-vaccine at Month 3 for all Groups||2021-04-30|04/2021||||
2558037|NCT02699099|Secondary|Number of Subjects With Seizures for All Groups, Post-vaccination for Vaccines Administered at 6, 7.5 or 9 Months of Age|Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It is assessed by the investigator as specific to the treatment administration.|Within 30 days post-vaccination for vaccine doses administered at Day 0, Month 1.5 or 42 days post-vaccination for vaccine doses administered at Month 3, vaccination period from Day 0 until Month 4.5.|Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.|||Participants|||Count of Participants
2558038|NCT02699099|Secondary|Number of Subjects With Meningitis for All Study Groups From Day 0 Until Study End|Meningitis is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It is assessed by the investigator as specific to the treatment administration.|During the entire study period (From Day 0 until Month 33 for Coad and RTS,S Groups and Month 36 for the Control Group)||2021-04-30|04/2021||||
2558039|NCT02699099|Secondary|Number of Subjects With Meningitis for All Study Groups From Day 0 Until Month 4.5|Meningitis is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It was assessed by the investigator as specific to the treatment administration.|From Day 0 up to Month 4.5|Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.|||Participants|||Count of Participants
2558040|NCT02699099|Secondary|Number of Subjects With pIMDs for All Study Groups From Day 0 Until Study End|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune etiology.|During the entire study period (From Day 0 until Month 33 for Coad and RTS,S Groups and Month 36 for the Control Group)||2021-04-30|04/2021||||
2558041|NCT02699099|Secondary|Number of Subjects With Potential Immune-Mediated Disease (pIMDs) for All Study Groups From Day 0 Until Month 4.5|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune etiology.|From Day 0 up to Month 4.5|Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.|||Participants|||Count of Participants
2558042|NCT02699099|Secondary|Number of Subjects With SAEs for All Study Groups From Day 0 Until Study End|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (From Day 0 until Month 33 for Coad and RTS,S Groups and Month 36 for the Control Group)||2021-04-30|04/2021||||
2558043|NCT02699099|Secondary|Number of Subjects With Any SAEs for All Study Groups, From Day 0 Until Month 4.5|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 up to Month 4.5|Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccines or Vitamin A administered.|||Participants|||Count of Participants
2558044|NCT02699099|Secondary|Number of Subjects With Serious Adverse Events (SAEs): All, Fatal and Related, for All Study Groups, Following Each Administration at Day 0, Month1.5 and Month 3|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During 30-Days period (Day of vaccination and 29 subsequent days) following each administration at Day 0, Month1.5 and Month 3 for Coad and RTS,S groups and at Day 0 and Month 3 in the Control Group.|Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.|||Participants|||Count of Participants
2558045|NCT02699099|Secondary|Number of Subjects With Unsolicited AEs for the Control Group, After Dose of Study Vaccine Administered at 10.5, 11.5, 12.5 and 30 Months of Age|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-Day Period (Day of vaccination and 29 subsequent days) after dose of study vaccine administered at Month 4.5, Month 5.5, Month 6.5 and Month 24||2021-04-30|04/2021||||
2558046|NCT02699099|Secondary|Number of Subjects With Unsolicited AEs for the Coad Group and RTS,S Group, After the Booster Dose of Study Vaccine Administered at 27 Months of Age|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period (Day of vaccination and 29 subsequent days) after booster dose administered at Month 21||2021-04-30|04/2021||||
2558055|NCT02699099|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = subject crying when limb was moved /spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimetres (mm) at injection site.|During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of SB257049 dose 2 (Month 1.5)|Analysis was performed on the Exposed set which included all subjects with the second dose of SB257049 administered (Coad and RTS,S Groups).|||Participants|||Count of Participants
2558047|NCT02699099|Secondary|Number of Subjects With Unsolicited AEs for All Study Groups, After Dose of Study Vaccines Administered at 9 Months of Age|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 42-day (vaccination day and 41 subsequent days) period after dose 3 of SB257049 in Coad (+MeRu+YF vaccines) and RTS,S groups, and 42-day period after MeRU+YF vaccination in Control group, administered at Month 3|Analysis was performed on the Exposed set which included all subjects with the third dose of the study vaccine for Coad (+MeRu+YF vacines) and RTS,S Groups, or MeRU + YF vaccine for the Control Group.|||Participants|||Count of Participants
2558048|NCT02699099|Secondary|Number of Subjects With Unsolicited AEs for the Control Group, at Visit at 7.5 Months of Age|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30-day period (Day of the visit and 29 subsequent days) after the visit at Month 1.5|Analysis was performed on the Exposed set which included all subjects from the Control Group who completed the visit at Month 1.5.|||Participants|||Count of Participants
2558049|NCT02699099|Secondary|Number of Subjects With Unsolicited AEs for the Coad Group and RTS,S Group, After Dose of Study Vaccines at 7.5 Months of Age|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 30-day (Day of vaccination and 29 subsequent days) period after dose 2 of SB257049 administered at Month 1.5 - Coad and RTS,S Groups|Analysis was performed on the Exposed set which included all subjects with the second dose of the study vaccine administered (Coad and RTS,S Groups).|||Participants|||Count of Participants
2558050|NCT02699099|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) for All Groups, After Administration of Vitamin A and Study Vaccines at 6 Months of Age|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 30-day (Days 0-29) period after dose 1 of SB257049 and Vitamin A- Coad and RTS,S Groups, and 30-day period after Vitamin A administration - Control Group|Analysis was performed on the Exposed set which included all subjects with first dose of the study vaccine + Vitamin A (Coad and RTS,S Groups) or Vitamin A (Control Group).|||Participants|||Count of Participants
2558051|NCT02699099|Secondary|Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age|Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = >150 lesions; Grade 3 Fever= temperature grater than (>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination.|During a 14-day follow-up period (day of administration and 13 subsequent days) after administration of SB257049 dose 3 in Coad (and MeRu+YF) and RTS,S Groups and after MeRu+YF vaccines in Control Group (Month 3)|Analysis was performed on the Exposed set which included all subjects with SB257049 dose 3 for Coad (and MeRu + YF vaccines) and RTS,S Groups, and MeRU+YF vaccines for Control Group.|||Participants|||Count of Participants
2558052|NCT02699099|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = subject crying when limb was moved /spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) at injection site.|During a 14-day follow-up period (day of administration and 13 subsequent days) after administration of SB257049 dose 3 in Coad (and MeRu+YF) and RTS,S Groups and after MeRu+YF vaccines in Control Group (Month 3)|Analysis was performed on the Exposed set which included all subjects with SB257049 dose 3 for Coad (and MeRu+YF vaccines) and RTS,S Groups, and MeRU+YF vaccines for Control Group.|||Participants|||Count of Participants
2558053|NCT02699099|Secondary|Number of Subjects With Solicited General Symptoms for the Control Group, After Visit at 7.5 Months of Age|Solicited symptoms were not analyzed for the Control Group after visit at Month 1.5 because no vaccination was administered at that visit.|After visit at Month 1.5|Analysis was not performed. Solicited symptoms were not collected for the Control group after visit at Month 1.5 because no vaccination was administered.||||||
2558054|NCT02699099|Secondary|Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age|Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = >150 lesions; Grade 3 Fever= temperature grater than (>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination.|During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of SB257049 dose 2 (Month 1.5)|Analysis was performed on the Exposed set which included all subjects with the second dose of SB257049 administered (Coad and RTS,S Groups).|||Participants|||Count of Participants
2558056|NCT02699099|Secondary|Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age|Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = >150 lesions; Grade 3 fever= temperature grater than (>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination.|During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of Vitamin A (Day 0)|Analysis was performed on the Exposed set which included all subjects with Vitamin A administered (Control group). In the Control Group, only solicited general symptoms were collected.|||Participants|||Count of Participants
2558057|NCT02699099|Secondary|Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age|Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = >150 lesions; Grade 3 fever= temperature grater than (>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination.|During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of Vitamin A and SB257049 dose 1 (Day 0)|Analysis was performed on the Exposed set which included all subjects with the first dose of SB257049 and Vitamin A administered (Coad and RTS,S Groups).|||Participants|||Count of Participants
2558058|NCT02699099|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = subject crying when limb was moved /spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) at injection site.|During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of Vitamin A and SB257049 dose 1 (Day 0)|Analysis was performed on the Exposed set which included all subjects with the first dose of SB257049 and Vitamin A administered (Coad and RTS,S Groups).|||Participants|||Count of Participants
2558059|NCT02699099|Secondary|Anti-YF Antibody Titers One Month Post-vaccination With the YF Vaccine|Titers were expressed as Geometric Mean Titres (GMTs). The antibody response of anti-YF was assessed in the Coad Group and Control Group.|At one month post-vaccination with the YF vaccine (Month 4)|Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.|||Titers||95% Confidence Interval|Geometric Mean
2558060|NCT02699099|Secondary|Number of Seropositive Subjects for Anti-Yellow Fever (Anti-YF) Antibodies, at One Month Post-vaccination With the YF Vaccine|Seropositivity was defined as number of subjects with anti-YF titers greater than or equal to (≥) 10 End point Dilution 50 (ED50). Seropositivity was assessed in the Coad group and Control group.|At one month post-vaccination with the YF vaccine (Month 4)|Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.|||Participants|||Count of Participants
2558061|NCT02699099|Secondary|Number of Seropositive Subjects for Anti-Ru Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine|A subject seropositive for anti-Ru antibody was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value (anti-Ru ≥ 4 IU/mL). Seropositivity was assessed in the Coad Group and Control Group.|At pre-vaccination (Month 3) and one month post-vaccination with combined measles and rubella vaccine (Month 4)|Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.|||Participants|||Count of Participants
2558062|NCT02699099|Secondary|Anti-Ru Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine|Concentrations were expressed as GMCs with the following unit of measure: International unit per milliliter (IU/mL). The antibody response of anti-Ru was assessed in the Coad Group and Control Group.|At pre-vaccination (Month 3) and one month post-vaccination with combined measles and rubella vaccine (Month 4)|Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.|||IU/mL||95% Confidence Interval|Geometric Mean
2558063|NCT02699099|Secondary|Number of Seroconverted Subjects for Anti-Rubella (Anti-Ru) Antibodies, One Month Post-vaccination With the Combined Measles and Rubella Vaccine|Seroconversion was defined as number of subjects with an anti-Ru pre-vaccination concentration less than (<) 4 IU/mL and a post-vaccination concentration ≥ 4 IU/mL. Seroconversion was assessed in the Coad group and Control group.|At one month post-vaccination with combined measles and rubella vaccine (Month 4)|Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.|||Participants|||Count of Participants
2558806|NCT02688842|Primary|In-stent Late Lumen Loss||9 month after stent implantation|A sum of 31 patients with 33 target lesions were analyzed by Quantitative Coronary Angiography (QCA). 7 participants did not participate in 9 month angiographic follow up.|||mm|target stent|Standard Deviation|Mean
2558064|NCT02699099|Secondary|Number of Seropositive Subjects for Anti-Me Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine|A subject seropositive for anti-CS antibody was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value (anti-Me ≥ 150 mIU/mL). Seropositivity was assessed in the Coad Group and the Control Group.|At pre-vaccination (Month 3) and one month post-vaccination with the combined measles and rubella vaccine (Month 4)|Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.|||Participants|||Count of Participants
2558065|NCT02699099|Secondary|Anti-Me Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine|Concentrations were expressed in GMCs with the following unit of measure: milli-international unit per milliliter (mIU/mL). The antibody response of anti-Me was assessed in the Coad Group and the Control Group.|At pre-vaccination (Month 3) and one month post-vaccination with combined measles and rubella vaccine (Month 4)|Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.|||mIU/mL||95% Confidence Interval|Geometric Mean
2558066|NCT02699099|Secondary|Number of Seroconverted Subjects for Anti-Measles (Anti-Me) Antibodies, One Month Post-vaccination With the Combined Measles and Rubella (MeRu) Vaccine|Seroconversion was defined as number of subjects with an anti-Measles antibodies pre-vaccination concentration below 150 mIU/mL and a post-vaccination concentration ≥150 mIU/mL. Seroconversion was assessed in the Coad group and the Control group.|At one month post-vaccination with the combined measles and rubella (MeRu) vaccine (Month 4)|Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.|||Participants|||Count of Participants
2558067|NCT02699099|Secondary|Number of Seroprotected Subjects for Anti-HB Antibodies, Pre-vaccination and One Month Post-Dose 3 of SB257049|Seroprotection rate for anti-HBs antibody was defined as the percentage of subjects with antibody concentrations greater than or equal to an established cut-off value (anti-HBs ≥ 10 milli-international unit per milliliter [mIU/mL]). Seroprotection was assessed in the Coad Group and the RTS,S Group.|At Day 0 and one month post-Dose 3 of SB257049 (Month 4)|Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.|||Participants|||Count of Participants
2558068|NCT02699099|Secondary|Anti-hepatitis B (Anti-HBs) Antibody Concentrations, Pre-vaccination and One Month Post-Dose 3 of SB257049|Concentrations were expressed as GMCs with the following unit of measure: milli-international unit per milliliter (mIU/mL). The antibody response of anti-HB was assessed in the Coad Group and the RTS,S Group.|At Day 0 and one month post Dose 3 of SB257049 (Month 4)|Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.|||mIU/mL||95% Confidence Interval|Geometric Mean
2558069|NCT02699099|Secondary|Number of Seropositive Subjects for Anti-CS Antibodies, Pre-vaccination and One Month Post Dose 3 of SB257049|A subject seropositive for anti-CS antibody was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value (anti-CS ≥ 1.9 ELISA unit per milliliter [EU/mL]). Seropositivity was assessed in the Coad Group and the RTS,S Group.|At Day 0 and one month post Dose 3 of SB257049 (Month 4)|Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.|||Participants|||Count of Participants
2558070|NCT02699099|Secondary|Anti-CS Antibody Concentrations, Pre-vaccination and One Month Post Dose 3 of SB257049|Concentrations were expressed as Geometric Mean Concentrations (GMCs) with the following unit of measure: ELISA units per milliliter (EU/mL). The 95% CI for the GMC was obtained by exponential transformation (base 10) of the 95% CI for the mean of the log transformed concentrations. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group.|At Day 0 and one month post Dose 3 of SB257049 (Month 4)|Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.|||EU/mL||95% Confidence Interval|Geometric Mean
2558071|NCT02699099|Primary|Anti-Circumsporozoite (Anti-CS) Antibody Concentrations, One Month Post Dose 3 of SB257049|Concentrations were expressed as Geometric Mean Concentrations (GMCs) with the following unit of measure: Enzyme Linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL). The 95% confidence intervals were calculated using the Analysis of Variance (ANOVA) model. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group.|At one month post Dose 3 of SB257049 (Month 4)|Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.|||EU/mL||95% Confidence Interval|Geometric Mean
2558166|NCT02697773|Secondary|Percentage of Participants With Adjudicated Joint Safety Outcomes|Incidence of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive osteoarthritis (OA) (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture.|Baseline up to Week 40|The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here, ‘Overall number of participants analyzed’ signifies participants analyzed by adjudication committee.|||percentage of participants||95% Confidence Interval|Number
2558072|NCT02698865|Secondary|Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 14, 28, 60 and 120|The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. Walking Pain Score is measured by question A1 on the WOMAC 3.1 Index. The WOMAC questionnaire used in this study was administered in the Numerical rating scale (NRS) format. Question A1 on the WOMAC 3.1 Index measures the amount of pain that a participant has when walking on a flat surface. It is one question that is collected on a scale from 0 to 10 where a score of 0 indicates no pain and a score of 10 indicates extreme pain.|Baseline, Day 14, 28, 60 and 120|SAS consists of all randomized participants who were enrolled in the study and received either Monovisc or Saline and were analyzed as per treatment received. Here 'n'(number analyzed) signifies participants who were evaluable at specified timepoints.|||Units on a scale||Standard Deviation|Mean
2558073|NCT02698865|Primary|Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 180|The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. Walking Pain Score is measured by question A1 on the WOMAC 3.1 Index. The WOMAC questionnaire used in this study was administered in the Numerical rating scale (NRS) format. Question A1 on the WOMAC 3.1 Index measures the amount of pain that a participant has when walking on a flat surface. It is one question that is collected on a scale from 0 to 10 where a score of 0 indicates no pain and a score of 10 indicates extreme pain.|Baseline and Day 180|Safety Analysis Set (SAS) consists of all randomized participants who were enrolled in the study and received either Monovisc or Saline and were analyzed as per treatment received. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure (OM).|||Units on a scale||Standard Deviation|Mean
2558074|NCT02698800|Secondary|Sleep Efficiency (Time Spent Asleep Divided by Total Time in Bed) Determined With Wrist-worn Accelerometry|Wrist-worn accelerometry gives an estimate of time spent asleep, time spent in bed, and sleep efficiency can be calculated from this. Sleep efficiency is calculated as time spent asleep divided by total time in bed. Here, we considered the mean calculated sleep efficiency over each 7-day treatment period.|After 7 nights of clear lenses|Participants who completed both phases|||% of total sleep time||Standard Deviation|Mean
2558075|NCT02698800|Secondary|Sleep Efficiency (Time Spent Asleep Divided by Total Time in Bed) Determined With Wrist-worn Accelerometry|Wrist-worn accelerometry gives an estimate of time spent asleep, time spent in bed, and sleep efficiency can be calculated from this. Sleep efficiency is calculated as time spent asleep divided by total time in bed. Here, we considered the mean calculated sleep efficiency over each 7-day treatment period.|After 7 nights of BB lenses|Participants who completed both phases|||% of total sleep time||Standard Deviation|Mean
2558076|NCT02698800|Primary|Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score|"Pittsburgh Insomnia Rating Scale-65; measures the self-reported severity of insomnia over the past week. Higher scores indicate worsened severity. There are 65 items, each scored on a 4-point scale from low-high on symptom severity or frequency. There is a Total score, and 3 subscales: Distress score (how bothersome the sleep impairment is), Sleep Parameters score (sleep quality), and Quality of Life score.~For the total score scoring is done by summing the scores from questions 1-65. Minimum Score=0 (good); Maximum Score=195 (bad) For the distress score, scoring is done by summing the scores from questions 1-46. Minimum Score=0 (not bothered); Maximum Score=138 (severely bothered) For the sleep parameters score, scoring is done by summing the scores from questions 47-56. Minimum Score=0 (good sleep); Maximum Score=30 (disrupted sleep) For the quality of life score, scoring is done by summing the scores from questions 57-65. Minimum Score=0 (excellent); Maximum Score=27 (poor)"|After 7 nights of clear lenses|Participants who complete both phases|||units on a scale||Standard Deviation|Mean
2558077|NCT02698800|Primary|Pittsburgh Insomnia Rating Scale-65 (PIRS65) Total Score|"Pittsburgh Insomnia Rating Scale-65; measures the self-reported severity of insomnia over the past week. Higher scores indicate worsened severity. There are 65 items, each scored on a 4-point scale from low-high on symptom severity or frequency. There is a Total score, and 3 subscales: Distress score (how bothersome the sleep impairment is), Sleep Parameters score (sleep quality), and Quality of Life score.~For the total score scoring is done by summing the scores from questions 1-65. Minimum Score=0 (good); Maximum Score=195 (bad) For the distress score, scoring is done by summing the scores from questions 1-46. Minimum Score=0 (not bothered); Maximum Score=138 (severely bothered) For the sleep parameters score, scoring is done by summing the scores from questions 47-56. Minimum Score=0 (good sleep); Maximum Score=30 (disrupted sleep) For the quality of life score, scoring is done by summing the scores from questions 57-65. Minimum Score=0 (excellent); Maximum Score=27 (poor)"|After 7 nights of BB lenses|Participants who completed both phases|||units on a scale||Standard Deviation|Mean
2558078|NCT02698735|Primary|Number of Participants With Anchoring Fibrils as Assessed by Immuno-electron Microscopy|The expression of anchoring fibril structures at the patients' dermal-epidermal junction was assessed by immuno-electron microscopy (IEM) using an antibody specific to type VII collagen. The IEM expression of anchoring fibrils was assessed before treatment and at one and three months after treatment. At each assessment time point, anchoring fibrils were compared with normal human skin. Baseline pre-treatment and one and three month post-treatment sites were compared for the presence of anchoring fibrils after gentamicin treatment (or increase if anchoring fibrils were detected at baseline in patients). Comparisons were also made between placebo-treated and gentamicin-treated sites.|3 months||||Participants|||Count of Participants
2558079|NCT02698735|Primary|Restoration of Full-length Type VII Collagen as Assessed by Immunofluorescence.|The expression of type VII collagen at the patients' dermal-epidermal junction was assessed by immunofluorescence (IF) using an antibody specific to type VII collagen. The expression was semi-quantitated using NIH Image J software. The IF expression of type VII collagen was assessed before treatment and at one and three months after treatment for each patient. All treated and untreated sites for all patients were also analyzed to determine statistical significance of treatment versus placebo for topical and intradermal administrations. At each assessment time point, type VII collagen expression was also measured in normal human skin. The expression of type VII collagen was then expressed as a percentage of the type VII collagen expressed in normal human skin.|3 months||||Fluorescence Intensity (MFI) for C7||Standard Error|Mean
2559598|NCT02675517|Secondary|Changes in the PF-10 Score From Visit 1 to Visit 2|Change in PF-10 score was determined by taking into account the individual change of each patient between Baseline (Visit 1) and Week 6 (approx.) (Visit 2).|baseline and approx. week 6|FAS|||Unit on Scale||Standard Deviation|Mean
2558080|NCT02698566|Primary|Percentage of PFS Usage Errors on Essential Tasks|Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. Essential tasks were those that were required in order to complete the use process for effective use of the product.|Day 1|Three HCP's referred to as 'participants' performed tasks on 35 enrolled patients by giving single PFS ITV injection to each patient. The percentages are calculated out of the total 35 PFS ITV injections administered.|||percentage of usage errors|ITV injections||Number
2558081|NCT02698566|Primary|Percentage of PFS Usage Errors on Safety Critical Tasks|Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. Safety critical tasks where those in which use error could have a reasonably foreseeable potential for clinical impact or harm.|Day 1|Three HCP's referred to as 'participants' performed tasks on 35 enrolled patients by giving single PFS ITV injection to each patient. The percentages are calculated out of the total 35 PFS ITV injections administered.|||percentage of usage errors|ITV injections||Number
2558082|NCT02698566|Primary|Percentage of Successful Task Completions|Product use tasks included sequence of steps starting from opening the carton, removing contents from carton to disposing of used PFS and needle. Tasks were considered to be successfully completed if the correct results were achieved without a use error, even if the instructions for use (IFU) were not followed exactly (example: not removing the needle cap prior to adjusting a dose). Usage error was defined as user action or lack of user action while using the medical device that led to a different result than intended by the manufacturer or expected by the user. The ability of HCPs to follow the IFU to prepare and administer a ranibizumab PFS ITV injection dose to patients was evaluated by successful task completion.|Day 1|Three HCPs referred to as 'participants' performed tasks on 35 enrolled patients by giving single PFS ITV injection to each patient. The percentages are calculated out of the total 35 PFS ITV injections administered.|||percentage of tasks|ITV injections||Number
2558083|NCT02698436|Secondary|Investigator Global Acne Assessment - Week 12|"Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.~0 Clear Residual hyperpigmentation and erythema may be present.~Almost Clear. A few scattered comedones and a few (less than five) small papules.~Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.~Moderate More than half of the face is involved. Numerous comedones, papules and pustules.~Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.~Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present."|12 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Score on a scale||Standard Deviation|Mean
2558084|NCT02698436|Secondary|Investigator Global Acne Assessment - Week 8|"Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.~0 Clear Residual hyperpigmentation and erythema may be present.~Almost Clear. A few scattered comedones and a few (less than five) small papules.~Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.~Moderate More than half of the face is involved. Numerous comedones, papules and pustules.~Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.~Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present."|8 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Score on a scale||Standard Deviation|Mean
2558085|NCT02698436|Secondary|Investigator Global Acne Assessment - Week 4|"Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.~0 Clear Residual hyperpigmentation and erythema may be present.~Almost Clear. A few scattered comedones and a few (less than five) small papules.~Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.~Moderate More than half of the face is involved. Numerous comedones, papules and pustules.~Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.~Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present."|4 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Score on a scale||Standard Deviation|Mean
2558086|NCT02698436|Secondary|Investigator Global Acne Assessment - Week 2|"Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.~0 Clear Residual hyperpigmentation and erythema may be present.~Almost Clear. A few scattered comedones and a few (less than five) small papules.~Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.~Moderate More than half of the face is involved. Numerous comedones, papules and pustules.~Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.~Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present."|2 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Score on a scale||Standard Deviation|Mean
2558087|NCT02698436|Secondary|Investigator Global Acne Assessment - Week 1|"Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.~0 Clear Residual hyperpigmentation and erythema may be present.~Almost Clear. A few scattered comedones and a few (less than five) small papules.~Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.~Moderate More than half of the face is involved. Numerous comedones, papules and pustules.~Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.~Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present."|1 Week|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Score on a scale||Standard Deviation|Mean
2558167|NCT02697773|Secondary|Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16 and 40||Baseline, Weeks 16 and 40|The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||beats per minute||Standard Deviation|Mean
2558088|NCT02698436|Secondary|Investigator Global Acne Assessment - Baseline|"Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.~0 Clear Residual hyperpigmentation and erythema may be present.~Almost Clear. A few scattered comedones and a few (less than five) small papules.~Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.~Moderate More than half of the face is involved. Numerous comedones, papules and pustules.~Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.~Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present."|Baseline|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Score on a scale||Standard Deviation|Mean
2558089|NCT02698436|Secondary|Acne Lesion Counts Total Global Face - Week 12|Acne Lesion Count Total Global Face Week 12|12 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Lesion Count||Standard Deviation|Mean
2558090|NCT02698436|Secondary|Acne Lesion Counts Total Global Face - Week 8|Acne Lesion Count Total Global Face Week 8|8 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Lesion Count||Standard Deviation|Mean
2558091|NCT02698436|Secondary|Acne Lesion Counts Total Global Face - Week 4|Acne Lesion Count Total Global Face Week 4|4 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Lesion Count||Standard Deviation|Mean
2558092|NCT02698436|Secondary|Acne Lesion Counts Total Global Face - Week 2|Acne Lesion Count Total Global Face Week 2|2 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Lesion Count||Standard Deviation|Mean
2558093|NCT02698436|Secondary|Acne Lesion Counts Total Global Face - Week 1|Acne Lesion Count Total Global Face Week 1|1 Week|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Lesion Count||Standard Deviation|Mean
2558094|NCT02698436|Secondary|Acne Lesion Counts Total Global Face - Baseline|Acne Lesion Count Total Global Face at Baseline|Baseline|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Lesion Count||Standard Deviation|Mean
2558095|NCT02698436|Secondary|Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 8||Baseline to 8 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Percent change of acne lesion count||95% Confidence Interval|Mean
2558096|NCT02698436|Secondary|Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 4||Baseline to 4 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Percent change of acne lesion count||95% Confidence Interval|Mean
2558097|NCT02698436|Secondary|Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 2||Baseline to 2 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Percent change of acne lesion count||95% Confidence Interval|Mean
2558098|NCT02698436|Secondary|Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 1||Baseline to 1 Week|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Percent change of acne lesion count||95% Confidence Interval|Mean
2558099|NCT02698436|Primary|Percent Change of Global Face Total Acne Lesion Count From Baseline||Baseline to 12 Weeks|Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.|||Percent change of acne lesion count||95% Confidence Interval|Mean
2558100|NCT02698423|Secondary|Proportion of Women With a Positive HPV Self-test Who Underwent All the Recommended Follow-up Clinical Investigations.|Assess the compliance with further follow-up among women having tested positive for the presence of HPV at baseline screening.|1 year||||Participants|||Count of Participants
2558101|NCT02698423|Primary|Number of Participants Who Performed HPV Self-testing Compared to the Number of Participants Who Responded to the Invitation to Come to the Hospital for Pap Testing|Compare the participation rate to cervical cancer screening for home-based human papillomavirus testing based on self-sampling versus clinic-based, physician-performed Pap testing.|1 year||||Participants|||Count of Participants
2558102|NCT02698371|Secondary|Gingival Bleeding, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall|"Gingival Bleeding Clinical Acceptance was expressed as the number of NCCls restorations classified as (A)-No evidence of gingival bleeding adjacent to Class II restoration. NCCls restorations with not acceptable Gingival Bleeding criteria were classified as (B)-Evidence of gingival bleeding adjacent to Class II restoration. NCCLs restorations not observed due to retention/marginal integrity lost were scored as missing for other categories."|24 months|Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Gingival Bleeding, using USPHS criteria, at 24 month recall.|||NCCLs restorations|NCCLs restorations||Count of Units
2558103|NCT02698371|Secondary|Secondary Caries, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall|"Secondary Caries Clinical Acceptance was expressed as the number of NCCls restorations classified as (A)-No evidence of caries. NCCls restorations with not acceptable Secondary Caries criteria were classified as (B)-Evidence of caries along the margin of the restoration. NCCLs restorations not observed due to retention/marginal integrity lost were scored as missing for other categories."|24 months|Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Secondary Caries, using USPHS criteria, at 24 month recall.|||NCCLs restorations|NCCLs restorations||Count of Units
2558104|NCT02698371|Secondary|Postoperative Sensitivity, Graded on a 2-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall|"Postoperative Sensitivity Clinical Acceptance was expressed as the number of NCCls restorations classified as (A)-No evidence of postoperative sensitivity. NCCls restorations with not acceptable Postoperative Sensitivity were classified as (B)-Experience of postoperative sensitivity. NCCLs restorations not observed due to retention/marginal integrity lost were scored as missing for other categories."|24 months|Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Postoperative Sensitivity, using USPHS criteria, at 24 month recall.|||NCCLs restorations|NCCLs restorations||Count of Units
2558105|NCT02698371|Secondary|Marginal Integrity, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall|"Marginal Integrity Clinical Acceptance was expressed as the number of NCCls restorations classified as (Alfa)-No visible evidence of crevice along the margin, (Bravo)-Visible evidence of a crevice along the margin into which the explorer will penetrateor (Charlie)-Dentin or the base is exposed. NCCls restorations with not acceptable Marginal Integrity were classified as (Delta)-Restoration is fractured, mobile or missing."|24 months|Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Marginal Integrity, using USPHS criteria, at 24 month recall.|||NCCLs restorations|NCCLs restorations||Count of Units
2558106|NCT02698371|Secondary|Retention, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall|"Retention Clinical Acceptance was expressed as the number of NCCls restorations classified as (Alfa)-Retained or (Bravo)-Partially retained. NCCls restorations with not acceptable Retention were classified as (Charlie)-Missing."|24 months|Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Retention, using USPHS criteria, at 24 month recall.|||NCCLs restorations|NCCLs restorations||Count of Units
2558107|NCT02698371|Secondary|Color Match, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall|"Color Match Clinical Acceptance was expressed as the number of NCCls restorations classified as (Alfa)-Restoration matches the adjacent tooth structure in color and translucency or (Bravo)-Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. NCCls restorations with not acceptable Color Match were classified as (Charlie)-The mismatch in color and translucency is outside the acceptable range of tooth color and translucency. NCCLs restorations not observed due to retention/marginal integrity lost were scored as missing for other categories."|24 months|Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Color Match, using USPHS criteria, at 24 month recall.|||NCCLs restorations|NCCLs restorations||Count of Units
2558108|NCT02698371|Secondary|Marginal Discoloration, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall|"Marginal Discoloration Clinical Acceptance was expressed as the number of NCCls restorations classified as (Alfa)-No discoloration along the margin between the restoration and adjacent tooth or (Bravo)-Slight discoloration along the margin between the restoration and the adjacent tooth (removable, usually localized). NCCls restorations with not acceptable Marginal Discoloration were classified as (Charlie)-Deep staining cannot be polished away. NCCLs restorations not observed due to retention/marginal integrity lost were scored as missing for other categories."|24 months|Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Marginal Discoloration, using USPHS criteria, at 24 month recall.|||NCCLs restorations|NCCLs restorations||Count of Units
2558109|NCT02698371|Secondary|Surface Staining, Graded on a 3-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall|"Surface Staining Clinical Acceptance was expressed as the number of NCCls restorations classified as (Alfa)- No staining in the restoration and/or the tooth or (Bravo)-Slight staining in the restoration and/or the tooth. NCCls restorations with not acceptable Surface Staining were classified as (Charlie)-The staining penetrated in the restoration and/or the tooth in a pulpal direction. NCCLs restorations not observed due to retention/marginal integrity lost were scored as missing for other categories."|24 months|Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Surface Staining, using USPHS criteria, at 24 month recall.|||NCCLs restorations|NCCLs restorations||Count of Units
2558110|NCT02698371|Secondary|Tooth Integrity (Enamel Cracks), Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall|"Tooth Integrity (enamel cracks) Clinical Acceptance was expressed as the number of NCCls restorations classified as (81)-Complete integrity, (82)-Small margin enamel(<150 µm) or Hairline crack in enamel (<150 µm not probable), (83)-Enamel split(<250 µm) or Crack< 250 µm, no adverse effects, (84)-Major enamel split (gap>250 µm or dentine or base exposed) or Crack>250 µm (probe penetrates). NCCls restorations with not acceptable Tooth Integrity (enamel cracks) criteria were classified as (85)-Cusp or tooth fracture. NCCLs restorations not observed due to retention/marginal integrity lost were scored as missing for other categories."|24 months|Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Tooth Integrity (enamel cracks), using FDI criteria, at 24 month recall.|||NCCLs restorations|NCCLs restorations||Count of Units
2558111|NCT02698371|Secondary|Recurrence of Caries, Erosion, Abfraction, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall|"Recurrence of Caries, Erosion, Abfraction Clinical Acceptance was expressed as the number of NCCls restorations classified as (71)-No secondary or primary caries, (72)-Very small and localized. No operative treatment required, (73)-Larger areas of: Demineralisation or Erosion or Abrasion/abfraction in dentine, localized and accessible and can be repaired, (74)-Caries with cavitation or Erosion in dentine or Abrasion/abfraction in dentine Localized and accessible and can be repaired. NCCls restorations with not acceptable Recurrence of Caries, Erosion, Abfraction criteria were classified as (75)-Deep secondary caries or exposed dentine that is not accessible for repair of restoration. NCCLs restorations not observed due to retention/marginal integrity lost were scored as missing for other categories."|24 months|Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Recurrence of Caries, Erosion, Abfraction, using FDI criteria, at 24 month recall.|||NCCLs restorations|NCCLs restorations||Count of Units
2558112|NCT02698371|Secondary|Postoperative Hypersensibility, Tooth Vitality, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall|"Postoperative Hypersensibility, Tooth Vitality Clinical Acceptance was expressed as the number of NCCls restorations classified as (61)-No hypersensitivity, normal vitality, (62)-Low hypersensitivity for a limited period of time, normal vitality, (63)-Premature/slightly more intense or Delayed/weak sensitivity; no subjective complaints, no treatment needed, (64)-Premature/very intense or Extremely delayed/weak with subjective complaints or Negative sensitivity intervention necessary but not replacement. NCCls restorations with not acceptable Postoperative Hypersensibility, Tooth Vitality criteria were classified as (65)-Very intense, acute pulpitis or no vital; Endodontic treatment is necessary and restoration has to be replaced.NCCLs restorations not observed due to retention/marginal integrity lost were scored as missing for other categories."|24 months|Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Postoperative Hypersensibility, Tooth Vitality, using FDI criteria, at 24 month recall.|||NCCLs restorations|NCCLs restorations||Count of Units
2558113|NCT02698371|Secondary|Marginal Adaptation, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall|"Marginal Adaptation Clinical Acceptance was expressed as the number of NCCls restorations classified as (51)-Harmonious outline, no gaps, no discoloration, (52)-Marginal gap (50 µm) or Small marginal fracture removable by polishing, (53)-Gap< 150 µm not removable or Severe small enamel or dentin fractures, (54)- Gap> 250 µm or dentine exposed or Chip fracture damaging margins or Notable enamel or dentine wall fracture, (55)-Filling is loose but in situ. NCCLs restorations not observed due to retention lost were scored as missing for other categories."|24 months|Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Marginal Adaptation, using FDI criteria, at 24 month recall.|||NCCLs restorations|NCCLs restorations||Count of Units
2558114|NCT02698371|Secondary|Fractures and Retention, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall|"Fractures and Retention Clinical Acceptance was expressed as the number of NCCls restorations classified as (41)-Restoration retained, no fractures/cracks, (42)-Small hairline crack, (43)-Two or more or larger hairline cracks and/or chipping (not affecting the marginal integrity or proximal contact, (44)-Chipping fractures which damage marginal quality or proximal contacts; bulk fractures with or without partial loss(less than half of the restoration). NCCls restorations with not acceptable Fractures and Retention were classified (45)-Partial or complete loss of restoration."|24 months|Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Fractures and Retention, using FDI criteria, at 24 month recall.|||NCCLs restorations|NCCLs restorations||Count of Units
2558115|NCT02698371|Secondary|Colour Stability and Translucency, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall|"Colour Stability and Translucency Clinical Acceptance was expressed as the number of NCCls restorations classified as (31)-Good colour match no difference in shade and translucency, (32)-Minor deviations, (33)-Clear deviation but acceptable. Does not affect aesthetics, (34)-(Localised) clinically unsatisfactory but can be corrected by repair. NCCls restorations with not acceptable Colour Stability and Translucency were classified as (35)-Unacceptable. Replacement necessary. NCCLs restorations not observed due to retention lost were scored as missing for other categories."|24 months|Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Colour Stability and Translucency, using FDI criteria, at 24 month recall.|||NCCLs restorations|NCCLs restorations||Count of Units
2558116|NCT02698371|Secondary|Staining Margin, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall|"Staining Margin Clinical Acceptance was expressed as the number of NCCls restorations classified as (21)-No surface staining, (22)-Minor staining, easily removable, (23)-Moderate surface staining, also present on other teeth, not aesthetically unacceptable, (24)-Surface staining present on the restoration and is unacceptable; major intervention necessary for improvement. NCCls restorations with not acceptable Staining Margin were classified as (25)-Severe staining and/or subsurface staining (generalized or localized); not accessible for intervention. NCCLs restorations not observed due to retention lost were scored as missing for other categories."|24 months|Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Staining Margin, using FDI criteria, at 24 month recall.|||NCCLs restorations|NCCLs restorations||Count of Units
2558117|NCT02698371|Secondary|Surface Luster, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall|"Surface Luster Clinical Acceptance was expressed as the number of NCCls restorations classified as (11)-Luster comparable to enamel, (12)-Slightly dull, not noticeable from speaking distance, (13)-Dull surface but acceptable if covered with film of saliva, (14)- Rough surface, cannot be masked by saliva film, simple polishing is not sufficient. Further intervention necessary. NCCls restorations with not acceptable Surface Luster were classified as (15)-Quite rough, unacceptable plaque retentive surface. NCCLs restorations not observed due to retention lost were scored as missing for other categories."|24 months|Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Surface Luster, using FDI criteria, at 24 month recall.|||NCCLs restorations|NCCLs restorations||Count of Units
2558118|NCT02698371|Primary|FDI or USPHS Criteria Evaluation Outcomes for Esthetic, Functional and Biological Parameters, at 24th Month Follow-up.|"FDI or USPHS criteria evaluation outcomes for Esthetic, Functional and Biological parameters, at 24th month follow-up were expressed as the number os NCCLs With Clinical Acceptance for each parameter. NCCLs restorations not observed due to retention/marginal integrity lost were scored as missing for other categories."|24 months|Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed for Esthetic, Functional and Biological parameters, using FDI and USPHS criteria, at 24 month recall.|||NCCLs restorations|NCCLs restorations||Count of Units
2558413|NCT02693834|Secondary|Gait Symmetry|Using GAITRite for Self Selected Velocity (SSV) and Fast paced Velocity (FPV) walk Step symmetry was calculated as the ratio of affected step length over unaffected step length. Step symmetry was calculated for Self Selected Velocity (SSV) and Fast paced Velocity (FPV)|at baseline,1 week with DA AFO, 1 week with PLS AFO||||ratio||Standard Deviation|Mean
2558119|NCT02698371|Primary|Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 4-point Scale, Using USPHS Criteria at 24 Month Follow-up Recall|"Clinical Performance Acceptance was expressed as the number of NCCls restorations scored as Alfa and Bravo. NCCls restorations with not acceptable performance were scored as Charlie for Esthetic properties, for Retention criteria and for Biological properties, and also scored Delta for Marginal Adaptation criteria. NCCLs restorations not observed due to retention/marginal integrity lost were scored as missing for other categories."|24 months|Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed, using USPHS criteria, at 24 month recall.|||NCCLs restorations|NCCLs restorations||Count of Units
2558120|NCT02698371|Primary|Esthetic, Functional and Biological Clinical Performance Adhesive/Adhesion Mode of NCCLs Restoration, Graded on a 5-point Scale, Using FDI Criteria at 24 Month Follow-up Recall|"Clinical Performance Acceptance was expressed as the number of NCCls restorations scored as 1-Clinically excellent/ very good, 2-Clinically good (after correction, very good), 3-Clinically sufficient/ satisfactory (minor shortcomings with no adverse effects but not adjustable without damage to the tooth), 4-Clinically unsatisfactory (repair for prophylactic reasons). NCCls restorations with not acceptable performance were scored as 5-Clinically poor (replacement necessary) for clinical properties. NCCLs restorations not observed due to retention/marginal integrity lost were scored as missing for other categories."|24 months|Per protocol analysis Population, defined as participants completing (each one enrolled in several arms and received 1 to 6 restorations), and NCCLs restorations observed, using FDI criteria, at 24 month recall.|||NCCLs restorations|NCCLs restorations||Count of Units
2558121|NCT02698241|Primary|Safety of the Integrated Diagnostic and Medication Management (i.e. Percentage of Implemented Interventions Being Safe)|"The Integrated Diagnostic Medication Intervention Strategy was physician-directed and nurse-implemented and it was based on a heart failure risk score diagnostic feature of a Medtronic CRT-D device implanted in the patients with heart failure. Safety of this intervention strategy was measured as the percentage of implemented interventions being safe. Once initiated, the Integrated Diagnostic Medication Intervention Strategy would be regarded as being safe if all the following criteria were met:~The Integrated Diagnostic Medication Intervention applied to an episode was not terminated due to safety issues;~The Integrated Diagnostic Medication Intervention applied to an episode had not caused treatment-related adverse events (as adjudicated by the CEC)."|12 months post enrollment|All subjects who had received the Integrated Diagnostic Medication Intervention per protocol were in the scope of this endpoint analysis. The interest was the safety of implemented interventions|||percentage of safe interventions|Interventions Implemented||Number
2558122|NCT02698241|Primary|Effectiveness of the Integrated Diagnostic Medication Intervention Strategy (i.e. Percentage of Implemented Interventions Being Effective)|"The Integrated Diagnostic Medication Intervention Strategy was physician-directed and nurse-implemented and it was based on a heart failure risk score diagnostic feature of a Medtronic CRT-D device implanted in the patients with heart failure. Effectiveness of this intervention strategy was measured as the percentage of implemented interventions being effective. Once initiated, an Integrated Diagnostic Medication Intervention would be effective if all the following criteria were met:~The intrathoracic impedance of a subject recovered per defined criterion after completion of the Integrated Diagnostic Medication Intervention;~The subject had no HF-related event (as adjudicated by the CEC) during or in the next 14 days after completion of the Integrated Diagnostic Medication Intervention;~The subject had not experienced any adverse events that were related to the Integrated Diagnostic Medication Intervention per CEC adjudication and require medical care."|12 months post enrollment|All subjects who had received the Integrated Diagnostic Medication Intervention per protocol were in the scope of this endpoint analysis. The interest was the effectiveness of the implemented interventions.|||percentage of effective interventions|Interventions Implemented||Number
2558123|NCT02698189|Secondary|Change From Baseline in Bromodomain and Extra-Terminal Domain (BET) Protein Target Gene Expression at Predose on Day 8 of Cycle 1 (21-day Cycle)|Fold change from baseline (predose on Day 1 of Cycle 1 [21-day cycle]) in normalized gene expression ratios (nGER) for 49 target genes was measured to assess target engagement of BET proteins predose on Day 1 and predose on Day 8 of Cycle 1 (21-day cycle) using quantitative polymerase chain reaction (qPCR). Data were normalized by the delta-delta cycle threshold (Ct) method using housekeeping genes. Fold change from baseline was calculated as nGER at predose Day 8/baseline in logarithmic scale with a base of 2 (Log2 scale). Per protocol, target genes were assessed across all study participants by dose and this assessment was not related to any specific disease cohort. The fold change in nGER for each target gene is presented for participants pooled from the AML and DLBCL cohorts since both cohorts received the same dose. A two-fold increase in gene expression indicated a +1 Log2 fold change. Conversely, a two-fold decrease in gene expression indicated a -1 Log2 fold change.|Baseline (predose on Day 1 of Cycle 1) and predose on Day 8 of Cycle 1 (21-day cycle)|The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received 14 doses of MK-8628 20 mg by Day 8 of Cycle 1 (21-day cycle) and had data available for the gene expression analysis.|||Log2 scale fold change||Standard Deviation|Mean
2558124|NCT02698189|Secondary|Change From Baseline in Bromodomain and Extra-Terminal Domain (BET) Protein Target Gene Expression at 12 Hours Postdose on Day 1 of Cycle 1 (21-day Cycle)|Fold change from baseline (predose on Day 1 of Cycle 1 [21-day cycle]) in normalized gene expression ratios (nGER) for 49 target genes was measured to assess target engagement of BET proteins predose and 12 hours postdose using quantitative polymerase chain reaction (qPCR). Data were normalized by the delta-delta cycle threshold (Ct) method using housekeeping genes. Fold change from baseline was calculated as nGER at 12 hours postdose Day 1/baseline in logarithmic scale with a base of 2 (Log2 scale). Per protocol, target genes were assessed across all study participants by dose and this assessment was not related to any specific disease cohort. The fold change in nGER for each target gene is presented for participants pooled from the AML and DLBCL cohorts since both cohorts received the same dose. A two-fold increase in gene expression indicated a +1 Log2 fold change. Conversely, a two-fold decrease in gene expression indicated a -1 Log2 fold change.|Baseline (predose on Day 1 of Cycle 1 [21-day cycle]) and 12 hours postdose on Day 1 of Cycle 1 (21-day cycle)|The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received two doses of MK-8628 20 mg on Day 1 of Cycle 1 (21-day cycle) and had data available for the gene expression analysis.|||Log2 scale fold change||Standard Deviation|Mean
2558125|NCT02698189|Secondary|Change From Baseline in Bromodomain and Extra-Terminal Domain (BET) Protein Target Gene Expression at 8 Hours Postdose on Day 1 of Cycle 1 (21-day Cycle)|Fold change from baseline (predose on Day 1 of Cycle 1 [21-day cycle]) in normalized gene expression ratios (nGER) for 49 target genes was measured to assess target engagement of BET proteins predose and 8 hours postdose using quantitative polymerase chain reaction (qPCR). Data were normalized by the delta-delta cycle threshold (Ct) method using housekeeping genes. Fold change from baseline was calculated as nGER at 8 hours postdose Day 1/baseline in logarithmic scale with a base of 2 (Log2 scale). Per protocol, target genes were assessed across all study participants by dose and this assessment was not related to any specific disease cohort. The fold change in nGER for each target gene is presented for participants pooled from the AML and DLBCL cohorts since both cohorts received the same dose. A two-fold increase in gene expression indicated a +1 Log2 fold change. Conversely, a two-fold decrease in gene expression indicated a -1 Log2 fold change.|Baseline (predose on Day 1 of Cycle 1 [21-day cycle]) and 8 hours postdose on Day 1 of Cycle 1 (21-day cycle)|The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received one dose of MK-8628 20 mg on Day 1 of Cycle 1 (21-day cycle) and had data available for the gene expression analysis.|||Log2 scale fold change||Standard Deviation|Mean
2558126|NCT02698189|Secondary|Change From Baseline in Bromodomain and Extra-Terminal Domain (BET) Protein Target Gene Expression at 3 Hours Postdose on Day 1 of Cycle 1 (21-day Cycle)|Fold change from baseline (predose on Day 1 of Cycle 1 [21-day cycle]) in normalized gene expression ratios (nGER) for 49 target genes was measured to assess target engagement of BET proteins predose and 3 hours postdose using quantitative polymerase chain reaction (qPCR). Data were normalized by the delta-delta cycle threshold (Ct) method using housekeeping genes. Fold change from baseline was calculated as nGER at 3 hours postdose Day 1/baseline in logarithmic scale with a base of 2 (Log2 scale). Per protocol, target genes were assessed across all study participants by dose and this assessment was not related to any specific disease cohort. The fold change in nGER for each target gene is presented for participants pooled from the AML and DLBCL cohorts since both cohorts received the same dose. A two-fold increase in gene expression indicated a +1 Log2 fold change. Conversely, a two-fold decrease in gene expression indicated a -1 Log2 fold change.|Baseline (predose on Day 1 of Cycle 1 [21-day cycle]) and 3 hours postdose on Day 1 of Cycle 1 (21-day cycle)|The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received one dose of MK-8628 20 mg on Day 1 of Cycle 1 (21-day cycle) and had data available for the gene expression analysis.|||Log2 scale fold change||Standard Deviation|Mean
2558127|NCT02698189|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/F) of MK-8628|Blood samples were collected to determine Vz/F at the following time points: Cycle 1 (21-day cycle) Day 1 at predose and 20 minutes, 1 hour, 2.25 hours, 3.25 hours, 8 hours and 12 hours postdose; Cycle 1 (21-day cycle) at predose on Days 8 and 15; and Cycle 2 (21-day cycle) at predose on Day 1. Per protocol, Vz/F for MK-8628 was assessed across all study participants by dose and this assessment was not related to any specific disease cohort. The Vz/F of MK-8628 after oral administration is presented for participants pooled from the AML and DLBCL cohorts since both cohorts received the same dose.|Up to 22 days post MK-8628 dose|The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received at least one dose of MK-8628 20 mg and had data available for Vz/F analysis.|||Liters||Standard Deviation|Mean
2558128|NCT02698189|Secondary|Apparent Total Body Clearance (CL/F) of MK-8628|Blood samples were collected to determine CL/F at the following time points: Cycle 1 (21-day cycle) Day 1 at predose and 20 minutes, 1 hour, 2.25 hours, 3.25 hours, 8 hours and 12 hours postdose; Cycle 1 (21-day cycle) at predose on Days 8 and 15; and Cycle 2 (21-day cycle) at predose on Day 1. Per protocol, CL/F for MK-8628 was assessed across all study participants by dose and this assessment was not related to any specific disease cohort. The CL/F of MK-8628 after oral administration is presented for participants pooled from the AML and DLBCL cohorts since both cohorts received the same dose.|Up to 22 days post MK-8628 dose|The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received at least one dose of MK-8628 20 mg and had data available for CL/F analysis.|||Liters/hr||Standard Deviation|Mean
2558129|NCT02698189|Secondary|Apparent Terminal Half-life (t1/2) for MK-8628|Blood samples were collected to determine t1/2 at the following time points: Cycle 1 (21-day cycle) Day 1 at predose and 20 minutes, 1 hour, 2.25 hours, 3.25 hours, 8 hours and 12 hours postdose; Cycle 1 (21-day cycle) at predose on Days 8 and 15; and Cycle 2 (21-day cycle) at predose on Day 1. Per protocol, t1/2 for MK-8628 was assessed across all study participants by dose and this assessment was not related to any specific disease cohort. The t1/2 of MK-8628 after oral administration is presented for participants pooled from the AML and DLBCL cohorts since both cohorts received the same dose.|Up to 22 days post MK-8628 dose|The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received at least one dose of MK-8628 20 mg and had data available for the t1/2 analysis.|||hr||Standard Deviation|Mean
2558130|NCT02698189|Secondary|Area Under the Concentration-Time Curve of MK-8628 From Time 0 to Infinity (AUC 0-∞)|Blood samples were collected to determine AUC 0-∞ at the following time points: Cycle 1 (21-day cycle) Day 1 at predose and 20 minutes, 1 hour, 2.25 hours, 3.25 hours, 8 hours and 12 hours postdose; Cycle 1 (21-day cycle) at predose on Days 8 and 15; and Cycle 2 (21-day cycle) at predose on Day 1. Per protocol, AUC 0-∞ for MK-8628 was assessed across all study participants by dose and this assessment was not related to any specific disease cohort. The AUC 0-∞ of MK-8628 after oral administration is presented for participants pooled from the AML and DLBCL cohorts since both cohorts received the same dose.|Up to 22 days post MK-8628 dose|The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received at least one dose of MK-8628 20 mg and had data available for the AUC 0-∞ analysis.|||hr*ng/mL||Standard Deviation|Mean
2558143|NCT02698176|Secondary|Area Under the Concentration-time Curve of MK-8628 From Time 0 to Infinity (AUC 0-∞)|Blood samples were obtained at specified time points for the PK analysis of AUC 0-∞ of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry. The AUC 0-∞ of MK-8628 after oral administration is presented.|Cycle1/Day 1: predose, 20 minutes, 1 hour, 2.25 hours (hrs), 3.25 hrs, 8 hrs, and 12 hrs postdose|Total number of participants from all 3 cohorts (CRPC+NMC+TNBC) in Part A of the study that received at least 1 dose of MK-8628 20 mg and had data available for the PK parameter being analyzed.|||hours•ng/mL||Standard Deviation|Mean
2558131|NCT02698189|Secondary|Observed Minimum Concentration (Cmin) of MK-8628|Blood samples were collected to determine Cmin at the following time points: Cycle 1 (21-day cycle) Day 1 at predose and 20 minutes, 1 hour, 2.25 hours, 3.25 hours, 8 hours and 12 hours postdose; Cycle 1 (21-day cycle) at predose on Days 8 and 15; and Cycle 2 (21-day cycle) at predose on Day 1. Per protocol, Cmin for MK-8628 was assessed across all study participants by dose and this assessment was not related to any specific disease cohort. The Cmin of MK-8628 after oral administration is presented for participants pooled from the AML and DLBCL cohorts since both cohorts received the same dose.|Up to 22 days post MK-8628 dose|The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received at least one dose of MK-8628 20 mg and had data available for the Cmin analysis.|||ng/mL||Standard Deviation|Mean
2558132|NCT02698189|Secondary|Time to Maximum Concentration (Tmax) of MK-8628|Blood samples were collected to determine Tmax at the following time points: Cycle 1 (21-day cycle) Day 1 at predose and 20 minutes, 1 hour, 2.25 hours, 3.25 hours, 8 hours and 12 hours postdose; Cycle 1 (21-day cycle) at predose on Days 8 and 15; and Cycle 2 (21-day cycle) at predose on Day 1. Per protocol, Tmax for MK-8628 was assessed across all study participants by dose and this assessment was not related to any specific disease cohort. The Tmax of MK-8628 after oral administration is presented for participants pooled from the AML and DLBCL cohorts since both cohorts received the same dose.|Up to 22 days post MK-8628 dose|The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received at least one dose of MK-8628 20 mg and had data available for the Tmax analysis.|||hr||Full Range|Median
2558133|NCT02698189|Secondary|Observed Maximum Concentration (Cmax) of MK-8628|Blood samples were collected to determine Cmax at the following time points: Cycle 1 (21-day cycle) Day 1 at predose and 20 minutes, 1 hour, 2.25 hours, 3.25 hours, 8 hours and 12 hours postdose; Cycle 1 (21-day cycle) at predose on Days 8 and 15; and Cycle 2 (21-day cycle) at predose on Day 1. Per protocol, Cmax for MK-8628 was assessed across all study participants by dose and this assessment was not related to any specific disease cohort. The Cmax of MK-8628 after oral administration is presented for participants pooled from the AML and DLBCL cohorts since both cohorts received the same dose.|Up to 22 days post MK-8628 dose|The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received at least one dose of MK-8628 20 mg and had data available for Cmax analysis.|||ng/mL||Standard Deviation|Mean
2558134|NCT02698189|Secondary|Disease Control Rate (DCR) in the Diffuse Large B Cell Lymphoma (DLBCL) Cohort Per International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014)|DCR was defined as the percentage of the participants in the DLBCL cohort who had stable disease, complete response (CR) or partial response (PR) as assessed by investigator review. Participants in the DLBCL cohort were assessed using computed tomography (CT) and positron emission tomography (PET)-CT and response was evaluated based on the Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). The criteria for CR included complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. The criteria for PR included: partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of the product of the perpendicular diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal).|Every 12 weeks starting from Cycle 5 (21-day cycle) until disease progression (up to 7 months)|The analysis population consisted of all participants in the DLBCL cohort who received at least one dose of study treatment and had data evaluable for DCR analysis.|||Percentage of participants||95% Confidence Interval|Number
2558135|NCT02698189|Secondary|Disease Control Rate (DCR) in the Acute Myeloid Leukemia (AML) Cohort Per International Working Group Criteria: European LeukemiaNet (Döhner et al, Blood, 2010)|DCR was defined as the percentage of the participants who had stable disease, complete response (CR) or partial response (PR) as assessed by investigator review. Participants in the AML cohort were assessed using bone marrow aspiration and hematologic criteria and response was evaluated based on European LeukemiaNet (Döhner et al, Blood, 2010). The criteria for complete response included: bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0 × 10^9/Liter; platelet count >100 × 10^9/Liter; and independence of red cell transfusions. The criteria for partial response included: decrease of bone marrow blast percentage to 5% to 25%; decrease of pretreatment bone marrow blast percentage by at least 50%; and all hematologic criteria associated with CR.|Every 3 weeks starting from Cycle 2 (21-day cycle) until disease progression (up to 7 months)|The analysis population consisted of all participants in the AML cohort who received at least one dose of study treatment and had data evaluable for DCR analysis.|||Percentage of participants||95% Confidence Interval|Number
2558136|NCT02698189|Secondary|Duration of Response (DOR) in the Diffuse Large B Cell Lymphoma (DLBCL) Cohort Per International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014)|DOR was defined as the time from complete response (CR) or partial response (PR) to documented disease progression or death as assessed by investigator review. Participants in the DLBCL cohort were assessed using computed tomography (CT) and positron emission tomography (PET)-CT and response was evaluated based on the Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). The criteria for CR included complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. The criteria for PR included: partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of the product of the perpendicular diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal).|Every 12 weeks starting from Cycle 5 (21-day cycle) until disease progression (up to 7 months)|The analysis population consisted of all participants in the DLBCL cohort who received at least one dose of study treatment and had data evaluable for DOR analysis. DOR could not be calculated because no participants met criteria for analysis: CR or PR and documented disease progression or death.||||||
2558153|NCT02698176|Secondary|Number of Participants Who Discontinued Study Treatment Due to an AE|The number of participants who discontinued study treatment due to an AE is presented.|From time of first dose until the end of treatment (up to 24 months)|Participants in Part A of the study that received at least 1 dose of MK-8628 20 mg. No participants were enrolled in Part B of the study.|||Participants|||Count of Participants
2558137|NCT02698189|Secondary|Duration of Response (DOR) in the Acute Myeloid Leukemia (AML) Cohort Per International Working Group Criteria: European LeukemiaNet (Döhner et al, Blood, 2010)|DOR was defined as the time from complete response (CR) or partial response (PR) to documented disease progression or death as assessed by investigator review. Participants in the AML cohort were assessed using bone marrow aspiration and hematologic criteria and response was evaluated based on European LeukemiaNet (Döhner et al, Blood, 2010). The criteria for complete response included: bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0 × 10^9/Liter; platelet count >100 × 10^9/Liter; and independence of red cell transfusions. The criteria for partial response included: decrease of bone marrow blast percentage to 5% to 25%; decrease of pretreatment bone marrow blast percentage by at least 50%; and all hematologic criteria associated with CR.|Every 3 weeks starting from Cycle 2 (21-day cycle) until disease progression (up to 7 months)|The analysis population consisted of all participants in the AML cohort who received at least one dose of study treatment and had data evaluable for DOR analysis. DOR could not be calculated because no participants met criteria for analysis: CR or PR and documented disease progression or death.||||||
2558138|NCT02698189|Secondary|Objective Response Rate (ORR) in the Diffuse Large B Cell Lymphoma (DLBCL) Cohort Per International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014)|ORR was defined as the percentage of the participants who had complete response (CR) or partial response (PR) as assessed by investigator review. Participants in the DLBCL cohort were assessed using computed tomography (CT) and positron emission tomography (PET)-CT and response was evaluated based on the Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). The criteria for CR included complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. The criteria for PR included: partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of the product of the perpendicular diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). The percentage of participants who achieved CR or PR is presented.|Every 12 weeks starting from Cycle 5 (21-day cycle) until disease progression (up to 7 months)|The analysis population consisted of all participants in the DLBCL cohort who received at least one dose of study treatment and had data evaluable for ORR analysis.|||Percentage of participants||95% Confidence Interval|Number
2558139|NCT02698189|Secondary|Objective Response Rate (ORR) in the Acute Myeloid Leukemia (AML) Cohort Per International Working Group Criteria: European LeukemiaNet (Döhner et al, Blood, 2010)|ORR was defined as the percentage of the participants who had complete response (CR) or partial response (PR) as assessed by investigator review. Participants in the AML cohort were assessed using bone marrow aspiration and hematologic criteria and response was evaluated based on European LeukemiaNet (Döhner et al, Blood, 2010). The criteria for complete response included: bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0 × 10^9/Liter; platelet count >100 × 10^9/Liter; and independence of red cell transfusions. The criteria for partial response included: decrease of bone marrow blast percentage to 5% to 25%; decrease of pretreatment bone marrow blast percentage by at least 50%; and all hematologic criteria associated with CR. The percentage of participants who achieved CR or PR is presented.|Every 3 weeks starting from Cycle 2 (21-day cycle) until disease progression (up to 7 months)|The analysis population consisted of all participants in the AML cohort who received at least one dose of study treatment and had data evaluable for ORR analysis.|||Percentage of participants||95% Confidence Interval|Number
2558140|NCT02698189|Secondary|Percentage of Participants Who Discontinued Study Treatment Due to an AE|The percentage of all participants who discontinued study treatment due to an AE is presented. These results are based on a 09-May-2018 data cutoff date.|From time of first dose until the end of treatment (up to 7 months)|The analysis population consisted of all participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2558141|NCT02698189|Secondary|Percentage of Participants Who Experienced At Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of all participants who experienced at least one AE is presented. These safety results are based on a 09-May-2018 data cutoff date.|From time of first dose until the end of follow-up (up to 8 months)|The analysis population consisted of all participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2558142|NCT02698189|Primary|Percentage of Participants With a Dose Limiting Toxicity (DLT)|DLT was any of the following drug related (DR) investigator-assessed adverse events: pancytopenia with hypocellular bone marrow and no marrow blasts lasting for ≥6 weeks; Grade (G)4 hematologic toxicity lasting ≥7 days except thrombocytopenia; G4 thrombocytopenia; G3 thrombocytopenia with bleeding; G3 or 4 febrile or infection-related neutropenia; G4 nonhematologic (NH) toxicity (not laboratory); G3 NH toxicity (not laboratory), nausea, vomiting, or diarrhea lasting >3 days despite supportive care; G3 or 4 NH laboratory abnormality requiring medical intervention, hospitalization, or persisting >1 week; increases in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin, or international normalization ratio indicative of significant liver impairment; DR adverse event leading to discontinuation or ≥20% missed planned doses in Cycle 1; DR toxicity causing >2 week delay in starting Cycle 2; or G5 toxicity.|From time of first dose up to the end of Cycle 1 (21-day cycle): up to 21 days|The population consisted of all participants that received at least 85% of the planned dose of study drug (18 days) or experienced a DLT during Cycle 1 (21-day cycle).|||Percentage of participants|||Number
2558165|NCT02697773|Secondary|Percentage of Participants With Total Joint Replacements|Percentage of participants who underwent total knee, hip or shoulder joint replacement surgery.|Baseline up to Week 40|The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously.|||percentage of participants||95% Confidence Interval|Number
2558414|NCT02693834|Primary|Gait Endurance|6MWT to assess gait endurance|1 week of practice with DA AFO and with PLS AFO randomly||||Meter||Standard Deviation|Mean
2558144|NCT02698176|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/F) of MK-8628|Blood samples were obtained at specified time points for the PK analysis of Vz/F of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry. The Vz/F of MK-8628 after oral administration is presented.|Cycle1/Day 1: predose, 20 minutes, 1 hour, 2.25 hours (hrs), 3.25 hrs, 8 hrs, and 12 hrs postdose|Total number of participants from all 3 cohorts (CRPC+NMC+TNBC) in Part A of the study that received at least 1 dose of MK-8628 20 mg and had data available for the PK parameter being analyzed.|||Liters||Standard Deviation|Mean
2558145|NCT02698176|Secondary|Apparent Total Body Clearance (CL/F) of MK-8628|Blood samples were obtained at specified time points for the PK analysis of Cl/F of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry. The Cl/F of MK-8628 after oral administration is presented.|Cycle1/Day 1: predose, 20 minutes, 1 hour, 2.25 hours (hrs), 3.25 hrs, 8 hrs, and 12 hrs postdose|Total number of participants from all 3 cohorts (CRPC+NMC+TNBC) in Part A of the study that received at least 1 dose of MK-8628 20 mg and had data available for the PK parameter being analyzed.|||Liters/hour||Standard Deviation|Mean
2558146|NCT02698176|Secondary|Apparent Terminal Half-Life (t1/2) of MK-8628|Blood samples were obtained at specified time points for the PK analysis of t1/2 of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry. The t1/2 of MK-8628 after oral administration is presented.|Cycle1/Day 1: predose, 20 minutes, 1 hour, 2.25 hours (hrs), 3.25 hrs, 8 hrs, and 12 hrs postdose|Total number of participants from all 3 cohorts (CRPC+NMC+TNBC) in Part A of the study that received at least 1 dose of MK-8628 20 mg and had data available for the PK parameter being analyzed.|||hours||Standard Deviation|Mean
2558147|NCT02698176|Secondary|Time to Maximum Concentration (Tmax) of MK-8628|Blood samples were obtained at specified time points for the PK analysis of Tmax of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry. The Tmax of MK-8628 after oral administration is presented.|Cycle1/Day 1: predose, 20 minutes, 1 hour, 2.25 hours (hrs), 3.25 hrs, 8 hrs, and 12 hrs postdose|Total number of participants from all 3 cohorts (CRPC+NMC+TNBC) in Part A of the study that received at least 1 dose of MK-8628 20 mg and had data available for the PK parameter being analyzed.|||hours||Full Range|Median
2558148|NCT02698176|Secondary|Observed Minimum Concentration (Cmin) of MK-8628|Blood samples were obtained at specified time points for the PK analysis of Cmin of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry. The Cmin of MK-8628 after oral administration is presented.|Cycle1/Day 1: predose, 20 minutes, 1 hour, 2.25 hours (hrs), 3.25 hrs, 8 hrs, and 12 hrs postdose|Total number of participants from all 3 cohorts (CRPC+NMC+TNBC) in Part A of the study that received at least 1 dose of MK-8628 20 mg and had data available for the PK parameter being analyzed.|||ng/mL||Standard Deviation|Mean
2558149|NCT02698176|Secondary|Observed Maximum Concentration (Cmax) of MK-8628|Blood samples were obtained at specified time points for the pharmacokinetic (PK) analysis of Cmax of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry. The Cmax of MK-8628 after oral administration is presented.|Cycle1/Day 1: predose, 20 minutes, 1 hour, 2.25 hours (hrs), 3.25 hrs, 8 hrs, and 12 hrs postdose|Total number of participants from all 3 cohorts (CRPC+NMC+TNBC) in Part A of the study that received at least 1 dose of MK-8628 20 mg and had data available for the PK parameter being analyzed.|||ng/mL||Standard Deviation|Mean
2558150|NCT02698176|Secondary|Disease Control Rate (DCR)|DCR was defined as the number of subjects with CR, PR, or stable disease (SD) as assessed by investigator radiologic review according to RECIST version 1.1 and PCWG2. CR: defined as disappearance of all target and all non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than <10 mm per RECIST 1.1. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters along with absence of new lesions and disease progression in non-target lesions per RECIST 1.1. SD: defined as, neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study per RECIST 1.1 and lack of a confirmed increase of at least two new lesions on a bone scan per PCWG2. The number of participants who experienced DCR is presented.|Assessed every 6 weeks from time of first dose until disease progression (up to 24 months)|Participants in Part A of the study who received at least one dose of MK-8628 20 mg. No participants were enrolled in Part B of the study.|||Participants|||Count of Participants
2558151|NCT02698176|Secondary|Duration of Response (DOR)|For participants who demonstrated CR or PR, DOR was defined as the time from first documented evidence of CR or PR per RECIST 1.1 until disease progression per RECIST 1.1 and PCWG2 or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression per RECIST 1.1. Per PCWG2, progressive disease was defined as a confirmed increase of at least two new lesions on a bone scan. DOR assessments were assessed by investigator radiologic review. The DOR for all participants who experienced a CR or PR is presented.|Assessed every 6 weeks from time of first dose until disease progression (up to 24 months)|Participants in Part A of the study who received at least one dose of MK-8628 20 mg. No participants were enrolled in Part B of the study. Since no participants experienced a CR or PR, DOR could not be calculated.||||||
2558152|NCT02698176|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1) and lack of progression according to the guidelines for prostate cancer endpoints developed by Prostate Cancer Clinical Trials Working Group (PCWG) 2 as assessed by investigator radiologic review. The number of participants who achieved a CR or PR is presented.|Assessed every 6 weeks from time of first dose until disease progression (up to 24 months)|Participants in Part A of the study who received at least one dose of MK-8628 20 mg. No participants were enrolled in Part B of the study.|||Participants|||Count of Participants
2558415|NCT02693834|Primary|Gait Endurance|6 Minute Walk test (6MWT) to assess gait endurance using DA AFO and PLS AFO|at baseline|6MWT using DA AFO|||Meter||Standard Deviation|Mean
2558154|NCT02698176|Secondary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. The number of participants who experienced at least one AE is presented.|From time of first dose until the end of the 30-day follow-up (up to 25 months)|Participants in Part A of the study that received at least 1 dose of MK-8628 20 mg. No participants were enrolled in Part B of the study.|||Participants|||Count of Participants
2558155|NCT02698176|Primary|Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1|A DLT was any of the following deemed drug related (DR) by investigator: Grade (G)4 hematologic toxicity lasting ≥7 days except thrombocytopenia; G4 thrombocytopenia; G3 thrombocytopenia with bleeding; G3 or 4 febrile neutropenia. G4 non-hematologic (NH) toxicity (not laboratory); G3 NH toxicity (not laboratory), nausea, vomiting, or diarrhea lasting >3 days despite supportive care; G3 or 4 NH laboratory abnormality requiring medical intervention, hospitalization, or persisting >1 week; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >8X Upper Limit of Normal(ULN); ALT or AST >5XULN for >2 weeks; ALT or AST >3XULN and total bilirubin >2XULN or international normalization ratio >1.5; ALT or AST >3XULN with fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash and/or eosinophilia (>5%); DR adverse event leading to discontinuation or >20% missed planned doses in Cycle 1; DR toxicity causing >2 week delay in starting Cycle 2; or G5 toxicity.|From time of first dose up to the end of the first cycle (up to 21 days)|Participants in Part A of the study that received at least 85% of the planned MK-8628 20 mg dose (18 days) or experienced a DLT during the first 21-day cycle.|||Participants|||Count of Participants
2558156|NCT02698033|Primary|Consistency of High Threshold Reactivity|The proportion of high-threshold peanut allergic individuals among participants who previously failed to react to a 443 mg peanut protein challenge in NCT01750879 who also reacted >443 cumulative total dose on repeat challenge|4 weeks|1 refused repeat challenge due to other allergic reactivity at time of scheduled procedure|||Participants|||Count of Participants
2558157|NCT02697890|Secondary|Keratinized Tissue Width (mm)|Assessed clinically by caliper/periodontal probe and radiographically by CBCT scans.|4 months after surgical procedure||||mm||Standard Deviation|Mean
2558158|NCT02697890|Secondary|Changes in Soft Tissues|Clinical measurements will be recorded using the prefabricated stent and its horizontal and vertical reference holes along with a caliper.|4 months after surgical procedure||||mm||Standard Deviation|Mean
2558159|NCT02697890|Secondary|Changes in Hard Tissues|Clinical measurements will be recorded using the prefabricated stent and its horizontal and vertical reference holes along with a caliper.|4 months after surgical procedure||||mm||Standard Deviation|Mean
2558160|NCT02697890|Primary|Changes in Alveolar Bone (mm)|Width of Alveolar Bone at 4, 7, and 10mm heights apical to the CEJ buccally and lingually. Mean of overall buccal and lingual/palatal height (reference hole to buccal and lingual bone top).Assessed clinically by caliper/periodontal probe and radiographically by CBCT scans|4 months after surgical procedure||||mm||Standard Deviation|Mean
2558161|NCT02697773|Secondary|Number of Participants With Anti-Tanezumab Antibodies|Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA). Participants listed as having anti-tanezumab antibodies had ADA titer level >=3.32. Less than 3.32 was considered below the limit of quantitation.|Baseline, Weeks 8,16, 24 and 40|The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||Participants|||Count of Participants
2558162|NCT02697773|Secondary|Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24 and 40|The SAS is a 12 item (11 for females) questionnaire, from which the total number of symptoms (0-12 for males and 0-11 for females) is calculated. Each positive symptom is rated from 1 (not at all) to 5 (a lot). The total impact score was the sum of all symptom rating scores, with 0 assigned where the participant did not have the particular symptom. The range for the total impact score is 0-60 for males and 0-55 for females, higher scores indicating higher impact.|Baseline, Weeks 24 and 40|The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||units on a scale||Standard Deviation|Mean
2558163|NCT02697773|Secondary|Number of Participants With Confirmed Orthostatic Hypotension|Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: For systolic BP <=150 mmHg (mean supine): Reduction in systolic BP>=20 mmHg or reduction in diastolic BP>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP >150 mmHg (mean supine): Reduction in systolic BP>=30 mmHg or reduction in diastolic BP>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed.|Baseline up to Week 40|The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here, ‘Overall number of participants analyzed’ signifies participants analyzed for this outcome measure.|||Participants|||Count of Participants
2558164|NCT02697773|Secondary|Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8,12,16, 24 and 40|NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis), higher score indicated higher abnormality/impairment and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent), higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment.|Baseline, Weeks 2, 4, 8,12,16, 24 and 40|The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||units on a scale||Standard Deviation|Mean
2558168|NCT02697773|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16 and 40|A 12-lead ECG was recorded after participants had rested for at least 5 minutes in the supine position in a quiet environment. All standard intervals (PR, QRS, QT, QTcF, QTcB, QTcF, RR intervals) were collected.|Baseline, Weeks 16, 40|The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||millisecond||Standard Deviation|Mean
2558169|NCT02697773|Secondary|Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12,16, 24, 40|Heart rate was measured at sitting position.|Baseline, Weeks 2, 4, 8, 12, 16, 24 and 40|The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified time points.|||beats per minute||Standard Deviation|Mean
2558170|NCT02697773|Secondary|Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 40|Measurement of BP included sitting systolic (SBP) and diastolic BP (DBP).|Baseline, Weeks 2, 4, 8, 12, 16, 24, 40|The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2558171|NCT02697773|Secondary|Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline|Primary Abnormality criteria: hemoglobin; hematocrit; RBC count < 0.8*LLN; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*ULN; platelets <0.5*LLN,>1.75*upper limit of normal (ULN); white blood cell count<0.6*LLN, >1.5*ULN; Lymphocytes, Leukocytes, Neutrophils <0.8*LLN, >1.2*ULN; Basophils, Eosinophils, Monocytes >1.2*ULN; Prothrombin time/Intl. normalized ratio >1.1*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides >1.3*ULN; Urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN; Hemoglobin A1C >1.3*ULN; creatine kinase >2.0*ULN; Urine erythrocytes >=20.|Baseline up to Week 40|The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here “Overall number of participants analysed” signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2558172|NCT02697773|Secondary|Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline|Primary Abnormality criteria: hemoglobin; hematocrit; RBC count [less than{<}0.8* lower limit of normal[LLN]; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*ULN; platelets <0.5*LLN,>1.75*upper limit of normal (ULN); white blood cell count<0.6*LLN, >1.5*ULN; Lymphocytes,Leukocytes,Neutrophils <0.8*LLN, >1.2*ULN; Basophils, Eosinophils, Monocytes >1.2*ULN; Prothrombin time/Intl. normalized ratio >1.1*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides >1.3*ULN; Urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN;Hemoglobin A1C >1.3*ULN; creatine kinase >2.0*ULN, specific gravity <1.003, >1.030; pH<4.5, >8; Urine Leukocytes >=20.|Baseline up to Week 40|The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously. Here “Overall number of participants analysed” signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2558173|NCT02697773|Secondary|Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 40 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.|Baseline up to Week 40|The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously.|||Participants|||Count of Participants
2558174|NCT02697773|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 40 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.|Baseline up to Week 40|The safety population was defined as all participants treated with Tanezumab or placebo subcutaneously.|||Participants|||Count of Participants
2558175|NCT02697773|Secondary|Amount of Rescue Medication Taken at Weeks 2, 4, 8, 12 and 16|In case of inadequate pain relief , acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in milligrams used during the specified week were summarized.|Week 2, 4, 8, 12, 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||milligrams||Standard Error|Least Squares Mean
2558176|NCT02697773|Secondary|Number of Days of Rescue Medication Use at Week 24|In case of inadequate pain relief, after Week 16, acetaminophen up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of days per week the participants used the rescue medication during the 4 weeks up to the particular study week were summarized.|Week 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Overall number of participants analyzed’ signifies participants who took rescue medication.|||days||Standard Deviation|Mean
2558416|NCT02693743|Primary|Beck Scale for Suicidal Ideation|Change in suicidal ideation between baseline assessment and following 3 day TMS trial.|Within the 3 days of the TMS trial.|No outcome measures were taken, subject did not receive TMS, due to technical difficulties. Subject was withdrawn by PI||||||
2558177|NCT02697773|Secondary|Number of Days of Rescue Medication Use at Week 2, 4, 8, 12 and 16|In case of inadequate pain relief during the treatment period, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. Number of days the participants used the rescue medication during the particular study weeks were summarized.|Week 2, 4, 8, 12, 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||days||Standard Error|Least Squares Mean
2558178|NCT02697773|Secondary|Number of Participants Who Took Rescue Medication During Week 24|In case of inadequate pain relief, after Week 16, acetaminophen up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of participants with any use of rescue medication during the 4 weeks up to the particular study week were summarized.|Week 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Overall number of participants analyzed’ signifies participants who took rescue medication.|||Participants|||Count of Participants
2558179|NCT02697773|Secondary|Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12 and 16|In case of inadequate pain relief, acetaminophen up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 16. Number of participants with any use of rescue medication during the particular study week were summarized.|Week 2, 4, 8, 12 and 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||Participants|||Count of Participants
2558180|NCT02697773|Secondary|Time to Discontinuation Due to Lack of Efficacy|Time to discontinuation due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy.|Baseline up to Week 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Overall number of participants analyzed’ signifies participants who discontinued from the study due to lack of efficacy.|||days||Full Range|Median
2558181|NCT02697773|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy|Number of participants who withdrew from treatment due to lack of efficacy have been reported here.|Baseline up to Week 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||Participants|||Count of Participants
2558182|NCT02697773|Secondary|Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis|Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 24 and Week 40. Domain evaluated was duration since quitting job due to OA.|Baseline, Weeks 24 and 40|ITT population: all randomized participants who received at least one dose of SC study medication (either Tanezumab or placebo). One additional participant apart from the ones who had responded for quitting job responded to duration since quitting job. ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||years||Full Range|Median
2558183|NCT02697773|Secondary|Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis|Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 24 and Week 40. Domain evaluated was number of participants who quit job due to OA.|Baseline, Weeks 24 and 40|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||Participants|||Count of Participants
2558184|NCT02697773|Secondary|Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things|Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Domain evaluated was number of participants who used any aids/devices for doing things. Aids such as walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices.|Baseline, Weeks 24 and 40|The intent to treat (ITT) population included all randomized participants who received at least one dose of subcutaneous (SC) study medication (either Tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||Participants|||Count of Participants
2558185|NCT02697773|Secondary|Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis|Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Domain evaluated was number of nights stayed in the hospital due to OA.|Baseline, Weeks 24 and 40|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||nights||Full Range|Median
2558186|NCT02697773|Secondary|Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis|Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Domain evaluated was number of participants who were hospitalized due to OA.|Baseline, Weeks 24 and 40|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||Participants|||Count of Participants
2558187|NCT02697773|Secondary|Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis|Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Domain evaluated was number of visits to the emergency room due to OA.|Baseline, Weeks 24 and 40|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||visits||Full Range|Median
2558225|NCT02697214|Primary|Measuring the Accuracy of Commercial Heart Rate Monitors.|The purpose of this study is to assess the accuracy of four popular, commercially available wrist-worn heart rate monitors compared to the current gold standard of a ECG using Lin's Concordance Correlation Coefficient.|20 minutes|All participants are represented in the analysis population.|||Correlation Coefficient|Heart Rate Monitors|95% Confidence Interval|Number
2558188|NCT02697773|Secondary|Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis|Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Domain evaluated was number of participants who visited the emergency room due to osteoarthritis (OA).|Baseline, Weeks 24 and 40|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||Participants|||Count of Participants
2558189|NCT02697773|Secondary|Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis|Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 40) and past 8 weeks (for Week 24). Visits of services directly related to osteoarthritis evaluated were: visits to primary care physician, neurologist, rheumatologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, podiatrist, nutritionist/dietitian, radiologist, home healthcare services and other practitioner.|Baseline, Weeks 24 and 40|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||visits||Full Range|Median
2558190|NCT02697773|Secondary|European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value|EQ-5D-5L: standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D health state profile comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Responses from the five domains were used to calculate a single utility index (the Overall health utility score) where values are <=1. The Overall health utility score for a patient with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a patient reports greater levels of problems across the five dimensions.|Baseline, Weeks 8 and 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||units on a scale||Standard Deviation|Mean
2558191|NCT02697773|Secondary|European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Dimensions Score|EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The health utility score for a patient with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a patient reports greater levels of problems across the five dimensions.|Baseline, Weeks 8 and 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||units on a scale||Standard Deviation|Mean
2558192|NCT02697773|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 16|WPAI is 6-question participant rated questionnaire to determine the impact of osteoarthritis on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline and Week 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||units on a scale||Standard Error|Least Squares Mean
2558193|NCT02697773|Secondary|Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline|WPAI is 6-question participant rated questionnaire to determine the impact of osteoarthritis on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||units on a scale||Standard Deviation|Mean
2558194|NCT02697773|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Week 24|"WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: How much pain have you had when going up or down the stairs? Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain."|Baseline, Week 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||units on a scale||Standard Deviation|Mean
2558226|NCT02697188|Secondary|Mean Serum Dihydrotestosterone Cmax|The objective of the study was to determine the single day serum pharmacokinetic profile for two oral formulations of T-esters (one TE and one TU formulation) administered once- and twice-daily to hypogonadal men.|24 hours post-dose in each period||||ng/dL||Standard Deviation|Mean
2558195|NCT02697773|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16|"WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: How much pain have you had when going up or down the stairs? Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain."|Baseline, Weeks 2, 4, 8, 12 and 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2558196|NCT02697773|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 24|"WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: How much pain have you had when walking on a flat surface?. Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain."|Baseline, Week 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||units on a scale||Standard Deviation|Mean
2558197|NCT02697773|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12 and 16|"WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: How much pain have you had when walking on a flat surface?. Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain."|Baseline, Weeks 2, 4, 8, 12 and 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2558198|NCT02697773|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 24|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.|Baseline, Week 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
2558199|NCT02697773|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.|Baseline, Weeks 2, 4, 8, 12 and 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2558200|NCT02697773|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip).The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.|Baseline, Week 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
2558201|NCT02697773|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12 and 16|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip).The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.|Baseline, Weeks 2, 4, 8, 12 and 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2558202|NCT02697773|Secondary|Change From Baseline for Average Pain Score in the Index Joint at Weeks 20 and 24|Participants assessed their average pain in the index hip/knee in the past 24 hours using a scale ranging from 0 (no pain) to 10 (worst possible pain) weekly beginning at Week 16. Higher scores indicated higher pain. Data represents averages of the values reported during the 4-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.|Baseline, Weeks 20 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||units on a scale||Standard Deviation|Mean
2558203|NCT02697773|Secondary|Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16|Participants assessed their average pain in the index hip/knee in the past 24 hours using a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data represents averages of the values reported during the 4-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.|Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12 and 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2558204|NCT02697773|Secondary|Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis|"PGA of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where, 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition. Percentage of participants with improvement of at least 2 points from Baseline in PGA of osteoarthritis were reported. Missing data was imputed using mixed BOCF/LOCF."|Weeks 2, 4, 8, 12, 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||percentage of participants|||Number
2558205|NCT02697773|Secondary|Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Physical function: participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale: 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (extreme difficulty),higher scores indicate extreme difficulty/worse physical function. Percentage of participants with cumulative reduction (as percent) (greater than 0 %; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC physical function subscale from Baseline to Week 16 were reported. Missing data was imputed using mixed BOCF/LOCF.|Baseline to Week 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||percentage of participants|||Number
2558206|NCT02697773|Secondary|Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response|Percentage of participants with reduction in WOMAC physical function of at least (>=) 30%, 50%, 70% and 90% at weeks 2, 4, 8, 12, 16 and 24 compared to baseline were classified as responders to WOMAC physical function subscale. WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Physical function refers to participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale: 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours,calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.|Weeks 2, 4, 8, 12, 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||percentage of participants|||Number
2558207|NCT02697773|Secondary|Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than 0% ; >= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in WOMAC pain subscale from Baseline to Week 16 were reported, participants (%) are reported more than once in categories specified. Missing data was imputed using mixed BOCF/LOCF.|Baseline to Week 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||percentage of participants|||Number
2558227|NCT02697188|Primary|Mean Serum Testosterone Cavg|The objective of the study was to determine the single day serum pharmacokinetic profile for two oral formulations of T-esters (one TE and one TU formulation) administered once- and twice-daily to hypogonadal men.|Concentrations at -0.5, 0, 1, 2, 4, 8, 12, 13, 14, 16, 20, 24 and 34 hours post dose||||ng/dL||Standard Deviation|Mean
2560871|NCT02658149|Secondary|Opioid Usage In-hospital at 24 Hours|Total amount of opioids used per patient (measured with Morphine Equivalent Units)|24 hours postoperatively||||Morphine Equivalent Units (Oral)||Standard Deviation|Mean
2558208|NCT02697773|Secondary|Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >= 30 Percent (%), >=50%, >=70% and >=90% Response|Percentage of participants with reduction in WOMAC pain intensity of at least (>=) 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 12, 16 and 24 compared to baseline were classified as responders to WOMAC pain subscale and are reported here. WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Missing data was imputed using mixed BOCF/LOCF.|Week 2, 4, 8, 12, 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||percentage of participants|||Number
2558209|NCT02697773|Secondary|Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index|Participants were considered as OMERACT-OARSI responders: if the change (improvement) from baseline to week of interest was greater than or equal to (>=) 50 percent and greater or equal to (>=) 2 units in either WOMAC pain subscale or physical function subscale score; if change (improvement) from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [extreme difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition). Missing data was imputed using mixed baseline/last observation carried forward (BOCF/LOCF).|Weeks 2, 4, 8, 12, 16 and 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||percentage of participants|||Number
2558210|NCT02697773|Secondary|Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 24|"PGA of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition."|Baseline, Week 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
2558211|NCT02697773|Secondary|Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12|"PGA of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities)."|Baseline, Weeks 2, 4, 8 and 12|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2558212|NCT02697773|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (extreme difficulty), where higher scores indicated maximum difficulty/worse physical function.|Baseline, Week 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
2558213|NCT02697773|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.|Baseline, Weeks 2, 4, 8 and 12|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2558228|NCT02696967|Secondary|Number of Patients With Increase in Anti-CLR325 and Anti-apelin Antibodies in Serum|Anti-CLR325 anti-apelin antibodies in serum were analyzed predose, Day 10 and Day 28 to determine the immunogenicity of an 18-hour i.v. infusion of CLR325 in heart failure patients.|Baseline (BL), Day 10 (D10) and Day 28 (D28)|The Safety population, which consisted of all patients who had been exposed to at least one infusion of study drug or placebo, was considered. Only subjest with or without anitbody detected were included in the analysis.|||Participants|||Count of Participants
2558214|NCT02697773|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.|Baseline, Week 24|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo). Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
2558215|NCT02697773|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8 and 12|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.|Baseline, Weeks 2, 4, 8 and 12|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2558216|NCT02697773|Primary|Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16|"PGA of osteoarthritis was assessed by asking a question from participants: Considering all the ways your osteoarthritis in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition."|Baseline, Week 16|The intent to treat population was defined as all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2558217|NCT02697773|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.|Baseline, Week 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2558218|NCT02697773|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.|Baseline, Week 16|The intent to treat population included all randomized participants who received at least one dose of subcutaneous study medication (either Tanezumab or placebo).|||units on a scale||Standard Error|Least Squares Mean
2558219|NCT02697435|Primary|Participants' Average 7-day Self-reported Level of Low Back Pain as Assessed by 0-10 Numeric Rating Scale|Pain rated on a scale of 0 to 10, where 0 is no pain and 10 is worst possible pain. Outcome is change score.|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
2558220|NCT02697435|Primary|Participants' Level of Low Back Pain-associated Disability as Assessed by Roland Morris Disability Questionnaire (RMDQ)|The Roland Morris Questionnaire is a 24 item yes/no measure of back pain interference with various daily activities. It is a well validated measure of low back pain disability. The total score ranges from 0 to 24 with a higher score meaning greater impairment. Our main outcome measure is reported as the change in Roland Morris score from baseline to 6 months.|Baseline and 6 months|All participants were called monthly for 6 months. One main outcome measure was Roland Morris score at 6 months.|||score on a scale||Standard Deviation|Mean
2558221|NCT02697292|Secondary|Change in Cognitive Assessment|Number of subjects who experienced stable or improved cognitive assessment. Cognitive status was measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The RBANS is a individually administered standardized battery of 12 tests that measure cognitive decline or improvement taking approximately 30 minutes. Five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score (range 40-160)|baseline, 5 weeks|One subject did not complete the assessment at week 5 for the placebo arm|||Participants|||Count of Participants
2558222|NCT02697292|Primary|Change in Seizure Frequency From Baseline to 5 Weeks|The number of subjects who experience a ≥ 50% reduction in seizure frequency|baseline, 5 weeks||||Participants|||Count of Participants
2558223|NCT02697240|Primary|Plasma Citrulline Level||Plasma citrulline levels will be evaluated at the following time points: trough level, 10 minutes (peak level), 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours and 48 hours, to evaluate the pharmacokinetic profile||||micromol/hr/kg||Standard Deviation|Mean
2558224|NCT02697240|Primary|Number of Participants With Adverse Events|The number and severity of adverse event will be determined according to the NCI Common Terminology Criteria for Adverse Events (CTCAE)|30 days||||Participants|||Count of Participants
2558229|NCT02696967|Secondary|Pharmacokinetic of CLR325 and CQJ295: Renal Clearance From Plasma (CLr) Following Drug Administration|CLr is the renal clearance from urine following CLR325 infusion. The urine PK parameters were measured using an non-compartmental methods. Only descriptive analysis performed.|0-28 hours on Day 1|Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered.|||mL/hr||Geometric Coefficient of Variation|Geometric Mean
2558230|NCT02696967|Secondary|Pharmacokinetic of CLR325 and CQJ295: Amount of Drug (or Defined Metabolite) Excreted Into the Urine From Time (Ae 0-28 Hours)|Ae 0-28 hours is the amount of drug (or defined metabolite) excreted into the urine from time zero to 28 hours after the start of CLR325 infusion. The urine PK parameters were measured using an non-compartmental methods. Only descriptive analysis performed.|0-28 hours on Day 1|Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered.|||ng||Geometric Coefficient of Variation|Geometric Mean
2558231|NCT02696967|Secondary|Pharmacokinetic of CLR325: Volume of Distribution at Steady State Following Intravenous Administration (Vss)|Vss is the volume of distribution at steady state following intravenous administration. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed.|0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1|Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered.|||mL||Geometric Coefficient of Variation|Geometric Mean
2558232|NCT02696967|Secondary|Pharmacokinetic of CLR325 and CQJ295: Time to Reach the Maximum Concentration After Drug Administration (TMax)|Tmax is the time to reach maximum plasma concentration after single dose administration. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed.|0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1|Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered.|||hr||Full Range|Median
2558233|NCT02696967|Secondary|Pharmacokinetic of CLR325 and CQJ295: Terminal Elimination Half-life (T1/2)|T^1/2 is the elimination half-life associated with the terminal slope of a semi logarithmic concentration-time curve. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed.|18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1|Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered.|||hr||Standard Deviation|Mean
2558234|NCT02696967|Secondary|Pharmacokinetic of CLR325 and CQJ295: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss)|Cmax,ss is the observed maximum plasma concentration following drug administration at steady state. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed.|0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1|Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2558235|NCT02696967|Secondary|Pharmacokinetic of CLR325: Clearance From Plasma (CL) Following Drug Administration|CL is the systemic (or total body) clearance from plasma following CLR325 infusion. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed.|0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1|Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered.|||mL/hr||Geometric Coefficient of Variation|Geometric Mean
2558236|NCT02696967|Secondary|Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)|AUClast is the area under the plasma concentration-time curve from time zero to the last measurable concentration sampling time. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed.|0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1|Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2558237|NCT02696967|Secondary|Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)|AUCinf is the area under the plasma concentration-time curve from time zero to infinity. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed.|0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1|Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2558238|NCT02696967|Secondary|Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From From Time Zero to 28 Hours (AUC0-28hrs)|AUC0-28hr is the area under the plasma concentration-time curve from time zero to 28 hours after the start of CLR325 infusion. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed.|0, 0.5, 3, 5, 8, 10, 12, 18, 20, 24, and 28 hours post start of CLR325 infusion on Day 1|Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2560872|NCT02658149|Secondary|Pain Score at 24-48 Hours|Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain|measured once during time froma 24-48 hours postoperative||||units on a scale||Standard Deviation|Mean
2558239|NCT02696967|Secondary|Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From Time Zero to 18 Hours (AUC0-18hr)|AUC0-18hr is the area under the plasma concentration-time curve from time zero to 18 hours after the start of CLR325 infusion. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Only descriptive analysis performed.|0, 0.5, 3, 5, 8, 10, 12, and 18 hours post start of CLR325 infusion on Day 1|Participants from the Pharmacokinetic (PK) analysis set, defined as all randomized participants who received at least one dose of study drug and one evaluable PK concentration measurement, with data available for analysis were considered.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2558240|NCT02696967|Primary|Number of Patients With Adverse Events, Serious Adverse Events and Death|Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) in each treatment arm to demonstrate that CLR325 is safe for the treatment of chronic stable heart-failure patients through the monitoring of relevant clinical and laboratory safety parameters.|Day 1 to 28|The Safety population, which consisted of all patients who had been exposed to at least one infusion of study drug or placebo, was considered.|||Participants|||Count of Participants
2558241|NCT02696850|Other Pre-specified|Change in Endoscopic Scores|The change in Endoscopic Scores will be defined as the difference in the Lund-Kennedy Endoscopic score at baseline minus the Lund-Kennedy Endoscopic Score at 4 weeks and will be measured as the difference in scores on a scale that ranges from 0 to 20. Larger positive change reflects better response to treatment.|Baseline to 4 weeks||||score on a scale||Standard Deviation|Mean
2558242|NCT02696850|Secondary|Clinical Global Impression of Change (CGI)|"The overall response to treatment will be measured with a modification of the Clinical Global Impression of change (CGI) scale. Upon completion of the study, subjects will be asked to answer the following question: Overall, how would you rate your response to treatment? Response options are: 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse. Higher scores mean worse response to treatment."|4 weeks|"Reported counts of patients who self-reported minimally improved, much improved, or very much improved"|||Participants|||Count of Participants
2558243|NCT02696850|Primary|Change in SNOT-22 (Sino-Nasal Outcome Test)|"The change in Sino-Nasal Outcome test (SNOT-22) scores between baseline and four weeks will serve as the primary outcome measure in this study and will be calculated as:~Primary Outcome Measure, ∆SNOT-22 = SNOT-22 baseline — SNOT-22 4-week follow-up.~The change in SNOT-22 score is measured on a scale from -110 to 110 with positive scores showing improvement with treatment and negative scores showing worse condition after treatment."|Baseline to 4 weeks||||score on a scale||Standard Deviation|Mean
2558244|NCT02696798|Secondary|Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss)|Pharmacokinetics (PK): Steady-state trough serum concentration of Ixekizumab at week 16.|Week 16|All randomized participants who received study drug and have evaluable PK data.|||Microgram per milliliters (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2558245|NCT02696798|Secondary|Percentage of Participants With Anti-Ixekizumab Antibodies|A treatment emergent - antidrug antibody (TE-ADA) positive patient is defined as: a) a patient with a >= 4-fold increase over a positive baseline antibody titer; or b) for a negative baseline titer, a patient with an increase from the baseline to a level of >= 1:10. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.|Week 16|All randomized participants.|||Percentage of Participants|||Number
2558246|NCT02696798|Secondary|Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score|ASAS-NSAID score is used to present the NSAID intake by considering the type of NSAID, the total dose, & the number of days taking NSAID during a period of interest (PI). For NSAID equivalent scoring system, range is from 0 to 100, higher the score greated the NSAID intake. ASAS-NSAID score= (equivalent NSAID score) x (days of intake during PI) x (days per week)/(PI in days).|Baseline, Week 52|Participants from extended treatment period who had NSAID Intake at baseline.|||Units on a scale||Standard Deviation|Mean
2558247|NCT02696798|Secondary|Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores|The WPAI-SpA consists of 6 questions to determine employment status, hours missed from work because of SpA, hours missed from work for other reasons, hours actually worked, the degree to which SpA affected work productivity while at work, and the degree to which SpA affected activities outside of work. The WPAI-SpA has been validated in the rad-axSpA patient population. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. The computed percentage range for each sub-scale was from 0-100, with higher scores indicating greater impairment and less productivity. LS mean was determined by ANCOVA with treatment, geographic region, baseline CRP status, number of prior TNFi and baseline value as fixed factors.|Baseline, Week 16|All randomized participants with baseline and week 16 WPAI-SpA score.|||Units on a scale||Standard Error|Least Squares Mean
2558248|NCT02696798|Secondary|Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)|"The Jenkins Sleep Evaluation Questionnaire (JSEQ) is a 4 item scale designed to estimate sleep problems in clinical research. The JSEQ assesses the frequency of sleep disturbance in 4 categories: 1) trouble falling asleep, 2) waking up several times during the night, 3) having trouble staying asleep (including waking up far too early), and 4) waking up after the usual amount of sleep feeling tired and worn out. Patients report the numbers of days they experience each of these problems in the past month on a 6 point Likert Scale ranging from 0 = no days to 5 = 22-30 days. The total JSEQ score ranges from 0 to 20, with higher scores indicating greater sleep disturbance. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All randomized participants.|||Units on a scale||Standard Error|Least Squares Mean
2558330|NCT02695719|Secondary|SBM Frequency at Weeks 2, 3 and 4|A SBM was defined as any BM that does not occur within 24 hours after rescue medication use. Participants will be given a diary to complete at home where they will record all details of each SBM including the consistency of the stool and the difficulty they have in passing it.|Weeks 2, 3 and 4|FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method.|||SBMs/week||Standard Deviation|Mean
2558249|NCT02696798|Secondary|Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score|"The fatigue severity NRS is a participant administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing no fatigue and 10 representing as bad as you can imagine. Participants rate their fatigue (feeling tired or worn out) by circling the 1 number that describes their worst level of fatigue during the previous 24 hours. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All randomized participants.|||Units on a scale||Standard Error|Least Squares Mean
2558250|NCT02696798|Secondary|Percentage of Participants With Anterior Uveitis|Anterior uveitis is an inflammation of the middle layer of the eye. which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body.|Week 16|All randomized participants.|||Percentage of Participants|||Number
2558251|NCT02696798|Secondary|Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Scores|The number of swollen joints was determined by examination of 44 joints (22 joints on each side of the body). The 44 joints were assessed and classified as swollen or not swollen. Sum of all joints checked to be swollen divided by number of evaluable joints which was multiplied by 44 to obtain SJC score. The SJC score ranges from 0 (no swollen joints) to 44 (all joints swollen). LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction.|Baseline, Week 16|All randomized participants with baseline SJC > 0.|||Swollen Joint Count||Standard Error|Least Squares Mean
2558252|NCT02696798|Secondary|Change From Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Scores|The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the body). The 46 joints were assessed and classified as tender or not tender. Sum of all joints checked to be tender/painful divided by number of evaluable joints which was multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction.|Baseline, Week 16|All randomized participants with baseline TJC > 0.|||Tender Joint Count||Standard Error|Least Squares Mean
2558253|NCT02696798|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score|"The SPARCC enthesitis is an index used to measure the severity of enthesitis. The SPARCC assesses 16 sites for enthesitis using a score of 0 for no activity or 1 for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All randomized participants with baseline SPARCC Enthesitis score > 0.|||Units on a scale||Standard Error|Least Squares Mean
2558254|NCT02696798|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)|"The MASES is an index used to measure the severity of enthesitis. The MASES assesses 13 sites for enthesitis using a score of 0 for no activity or 1 for activity. Sites assessed include costochondral 1 (right/left), costochondral 7 (right/left), spinal iliaca anterior superior (right/left), crista iliaca (right/left), spina iliaca posterior (right/left), processus spinosus L5, and Achilles tendon proximal insertion (right/left). The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All randomized participants with baseline MASES score > 0.|||Units on a scale||Standard Error|Least Squares Mean
2558255|NCT02696798|Secondary|Change From Baseline in Occiput to Wall Distance|The participant is to make a maximum effort to touch the head against the wall when standing with heels and back against the wall (occiput). Then the distance from occiput to wall is measured. Two tries will be recorded. The better (smaller) measurement of 2 tries (in centimeters) will be used for analyses. LS mean was determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.|Baseline, Week 16|All randomized participants.|||cm||Standard Error|Least Squares Mean
2558256|NCT02696798|Secondary|Change From Baseline in Chest Expansion|Chest expansion is the difference, in centimeter (cm), between the circumference of the chest in maximal inspiration and maximal expiration. While patients have their hands resting on or behind the head, the assessor will measure the chest encircled length by centimeter (cm) at the fourth intercostal level anteriorly. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.|Baseline, Week 16|All randomized participants.|||centimeter(cm)||Standard Error|Least Squares Mean
2558257|NCT02696798|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)|"BASMI is a combined index comprising of 5 clinical measurements of spinal mobility in patients with radiographic axial spondyloarthritis (rad-axSpA).~Lateral Spinal Flexion~Tragus-to-wall distance~Lumbar Flexion (modified Schober)~Maximal intermalleolar distance and~Cervical rotation. The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their AS. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All randomized participants.|||Units on a scale||Standard Error|Least Squares Mean
2558417|NCT02693704|Primary|Listener's Subjective Preference|Listeners compare two audiovisual stimuli (diotic and spatialized) and Indicate their preference between binaural diotic (no spatialization), spatialized stimuli, or no preference. Results are given as the percentage of participant for the 3 possible answers in each group.|1 day of the experiment||||Percentage of participants|||Number
2558258|NCT02696798|Secondary|Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)|High sensitivity CRP is the measure of acute phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity. High sensitivity CRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, visit, and treatment-by-visit interaction as fixed factors.|Baseline, Week 16|All randomized participants.|||milligram per liter (mg/L)||Standard Error|Least Squares Mean
2558259|NCT02696798|Secondary|Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score)|MRI score of spine was assessed using SPARCC method. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) were scored for bone marrow edema. A single DVU has 18 scoring units, and each has score of 0 or 1, bringing the maximum total score to 414, the sum ranges from 0 to 414 with higher scores reflecting worse disease. Scoring was performed by central readers. LS mean was determined by ANCOVA with factors for treatment, geographic region, baseline CRP status, number of prior TNF inhibitors used and baseline value.|Baseline, Week 16|All randomized participants with baseline and week 16 SPARCC MRI score.|||Units on a scale||Standard Error|Least Squares Mean
2558260|NCT02696798|Secondary|Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] - Berlin Score)|The study used MRI with fat-saturating techniques such as short tau inversion recovery (STIR) to look for the presence of bone marrow edema. The Berlin modification of Ankylosing Spondylitis spine MRI score for activity (ASspiMRI) scoring technique assesses inflammation in each of the 23 disco-vertebral units (DVU) of the spine (from C2 to S1), capturing bone marrow edema. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema [less than or equal to 25% of DVU; 3=severe bone marrow edema (more that 50% of DVU)]. The composite score ranges from 0 to 69, with higher scores reflecting worse disease.LS mean was determined by analysis of covariance (ANCOVA) with treatment, geographic region, baseline CRP status, number of prior TNF inhibitors used and baseline value as fixed factors.|Baseline, Week 16|All randomized participants with baseline and week 16 ASSpiMRI score.|||Units on a scale||Standard Error|Least Squares Mean
2558261|NCT02696798|Secondary|Change From Baseline in ASAS Health Index (ASAS HI)|"The ASAS Health Index (ASAS HI) is a disease specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17 item instrument has scores ranging from 0 (good Health) to 17 (poor Health). Each item consists of 1 question that the patient needs to respond to with either I agree (score 1) or I do not agree (score 0). A score of 1 is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All randomized participants.|||Units on a scale||Standard Error|Least Squares Mean
2558262|NCT02696798|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores|The SF-36 is a 36-item participant administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The 2 overarching domains of mental well- being and physical well-being are captured by the Mental Component Summary and Physical Component Summary scores. T-scores are used for analysis. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LSmean was determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.|Baseline, Week 16|All randomized participants.|||Units on a scale||Standard Error|Least Squares Mean
2558263|NCT02696798|Secondary|Percentage of Participants Achieving ASDAS <2.1|"ASDAS is a composite index to assess disease activity in AS. ASDAS <2.1 defines moderate disease activity.~The parameters used for the ASDAS (with CRP as acute phase reactant) are~Total back pain~Patient global~Peripheral pain/swelling~Duration of morning stiffness and~CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity."|Week 16|All randomized participants.|||Percentage of Participants|||Number
2558264|NCT02696798|Secondary|Percentage of Participants Achieving ASDAS Inactive Disease|"ASDAS is a composite index to assess disease activity in AS. ASDAS Inactive Disease is defined as a score of <1.3.~The parameters used for the ASDAS (with CRP as acute phase reactant) are~Total back pain~Patient global~Peripheral pain/swelling~Duration of morning stiffness and~CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity."|Week 16|All randomized participants.|||Percentage of Participants|||Number
2558265|NCT02696798|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)|The BASFI is a participant-reported assessment that establishes a participant's functional baseline and subsequent response to treatment. The BASFI is composed with 10 questions to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Participants respond to each question using an NRS scale (range 0 to 10). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10, with a higher score indicating worse function. LS mean was determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.|Baseline, Week 16|All randomized participants.|||Units on a scale||Standard Error|Least Squares Mean
2560873|NCT02658149|Secondary|Pain Score at 3-24 Hours|Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain|measured once during time frame 3 hours-24 hours postoperative||||units on a scale||Standard Deviation|Mean
2558266|NCT02696798|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis (rad-axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. LSmean was determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.|Baseline, Week 16|All randomized participants.|||Units on a scale||Standard Error|Least Squares Mean
2558267|NCT02696798|Secondary|Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response|The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis (rad-axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. BASDAI50 represents an improvement of ≥50% of the BASDAI score from baseline.|Week 16|All randomized participants.|||Percentage of Participants|||Number
2558268|NCT02696798|Secondary|Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)|"ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are~Total back pain~Patient global~Peripheral pain/swelling~Duration of morning stiffness and~CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Least Square (LS) mean was determined by mixed-model repeated measures (MMRM) with treatment, geographic region, baseline CRP status, number of prior tumor necrosis factor inhibitor (TNFi), baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All randomized participants.|||Units on a scale||Standard Error|Least Squares Mean
2558269|NCT02696798|Secondary|Percentage of Participants Achieving an ASAS20 Response|"ASAS20 response is defined as a ≥20% improvement and an absolute improvement from baseline of ≥1 units (range 0 to 10) in ≥3 of 4 domains, and no worsening of ≥20% and ≥1 unit (range 0 to 10) in the remaining domain.~Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active).~Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).~Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function.~Inflammation based on Q5 & Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity & duration of stiffness): Score ranges from 0 (none) and 10 (very severe)."|Week 16|All randomized participants.|||Percentage of Participants|||Number
2558270|NCT02696798|Primary|Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response|"ASAS40 is defined as improvement from baseline of greater than or equal to (>=) 40 % and absolute improvement from baseline of at least 2 units (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain.~Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active).~Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).~Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function.~Inflammation based on Q5 & Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity & duration of stiffness): Score ranges from 0 (none) and 10 (very severe)."|Week 16|All randomized participants.|||Percentage of participants|||Number
2558271|NCT02696785|Secondary|Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score)|"MRI score of spine was assessed using SPARCC method. All 23 disco-vertebral units (DVUs) of the spine (from C2 to S1) are scored for bone marrow edema. A single DVU has a scoring range of 0 to 18, bringing the maximum total score to 414, with higher scores reflecting worse disease. Scoring was performed by central readers.~LSMean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors"|Baseline, Week 16|All randomized participants with baseline and week 16 SPARCC MRI score for spine.|||score on a scale||Standard Error|Least Squares Mean
2558272|NCT02696785|Secondary|Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC)|"The number of swollen joints was determined by examination of 44 joints (22 joints on each side of the participants body. The 44 joints are assessed and classified as swollen or not swollen. sum of all joints checked to be swollen divided by number of evaluable joints and then multiplied by 44 to obtain SJC score. The SJC score ranges from 0 (no swollen joints) to 44 (all joints swollen).~LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All randomized participants with baseline SJC > 0.|||score on a scale||Standard Error|Least Squares Mean
2558273|NCT02696785|Secondary|Pharmacokinetics: Trough Ixekizumab Concentration at Steady State (Ctrough ss)||Week 16|All randomized participants who received at least one dose of Ixekizumab.|||microgram per millilitre (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2558274|NCT02696785|Secondary|Number of Participants With Anti Ixekizumab Antibodies|A treatment emergent - antidrug antibody (TE-ADA) positive patient is defined as: a) a patient with a >= 4-fold increase over a positive baseline antibody titer; or b) for a negative baseline titer, a patient with an increase from the baseline to a level of >= 1:10.|Week 16|All randomized participants.|||Participants|||Count of Participants
2560874|NCT02658149|Primary|Pain Score at 3 Hours|Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain|3 hours postoperative||||units on a scale||Standard Deviation|Mean
2558275|NCT02696785|Secondary|Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score|ASAS-NSAID score is used to present the NSAID intake by considering the type of NSAID, the total dose, & the number of days taking NSAID during a period of interest (PI).. ASAS-NSAID score=(equivalent NSAID score)x(days of intake during PI)x(days per week)/(PI in days). Higher scores indicate greater NSAIDs intake. 0= no intake, 100 = equivalent NSAID intake.|Baseline, Week 52|Participants in Extended Treatment Period Population Who had NSAID Intake at Baseline.|||score on a scale||Standard Deviation|Mean
2558276|NCT02696785|Secondary|Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores|"The WPAI-SpA consists of 6 questions to determine employment status, hours missed from work because of SpA, hours missed from work for other reasons, hours actually worked, the degree to which SpA affected work productivity while at work, and the degree to which SpA affected activities outside of work. The WPAI-SpA has been validated in the rad-axSpA patient population. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. The computed percentage range for each sub-scale was from 0-100. Greater scores indicate greater impairment and less productivity.~LSMean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors."|Baseline, Week 16|All randomized participants.|||score on a scale||Standard Error|Least Squares Mean
2558277|NCT02696785|Secondary|Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)|"The JSEQ is a 4-item scale designed to estimate sleep problems in clinical research. The JSEQ assesses the frequency of sleep disturbance in 4 categories: 1) trouble falling asleep, 2) waking up several times during the night, 3) having trouble staying asleep (including waking up far too early), and 4) waking up after the usual amount of sleep feeling tired and worn out. Participants report the number of days they experience each of these problems in the past month on a 6-point Likert scale ranging from 0 = no days to 5 = 22-30 days. The total JSEQ score ranges from 0 to 20, with higher scores indicating greater sleep disturbance.~LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All randomized participants.|||score on a scale||Standard Error|Least Squares Mean
2558278|NCT02696785|Secondary|Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score|"The Fatigue Severity NRS is a participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing no fatigue and 10 representing as bad as you can imagine. Participants rate their fatigue (feeling tired or worn out) by circling the one number that describes their worst level of fatigue during the previous 24 hours.~LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All randomized participants.|||score on a scale||Standard Error|Least Squares Mean
2558279|NCT02696785|Secondary|Number of Participants With Anterior Uveitis or Uveitis Flares|Anterior uveitis is an inflammation of the middle layer of the eye which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body.|Baseline through Week 16|All randomized participants.|||Count of Participants|||Number
2558280|NCT02696785|Secondary|Change From Baseline in Severity of Peripheral Arthritis by Tender (TJC)|"The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the participants body. The 46 joints are assessed and classified as tender or not tender. sum of all joints checked to be tender/painful divided by number of evaluable joints which is multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful).~LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All randomized participants with baseline TJC > 0.|||score on a scale||Standard Error|Least Squares Mean
2558281|NCT02696785|Secondary|Change From Baseline in SPARCC Enthesitis Score|"The SPARCC enthesitis is an index used to measure the severity of enthesitis. The SPARCC assesses 16 sites for enthesitis using a score of 0 for no activity or 1 for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis.~LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All randomized participants with baseline SPARCC score > 0.|||score on a scale||Standard Error|Least Squares Mean
2558282|NCT02696785|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)|"The MASES is an index used to measure the severity of enthesitis .The MASES assesses 13 sites for enthesitis using a score of 0 for no activity or 1 for activity. Sites assessed include costochondral 1 (right/left), costochondral 7 (right/left), spinal iliaca anterior superior (right/left), crista iliaca (right/left), spina iliaca posterior (right/left), processus spinosus L5, and Achilles tendon proximal insertion (right/left). The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis.~LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All randomized participants with baseline MASES score > 0.|||score on a scale||Standard Error|Least Squares Mean
2558283|NCT02696785|Secondary|Change From Baseline in MRI Sacroiliac Joint(s) (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score|"Both left and right SIJ are scored for bone marrow edema.Each side has 6 slices and each slice has 6 scoring units, and each scoring unit has a score of 0 or 1. Total SIJ SPARCC scores can range from 0 to 72 with higher scores reflecting worse disease.~LSMean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors."|Baseline, Week 16|All randomized participants with baseline and week 16 SPARCC score.|||score on a scale||Standard Error|Least Squares Mean
2562102|NCT02641561|Secondary|The Number of Participants With Sepsis After ERCP as Assessed by Infectious Source Defined by Positive Microbiology Culture|positive blood culture|30 days after ERCP||||Participants|||Count of Participants
2558284|NCT02696785|Secondary|Change From Baseline in Occiput to Wall Distance|"The participant is to make a maximum effort to touch the head against the wall when standing with heels and back against the wall (occiput). Then the distance from occiput to wall is measured. Two tries will be recorded. The better (smaller) measurement of 2 tries (in centimeters) will be used for analyses.~LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All randomized participants.|||cm||Standard Error|Least Squares Mean
2558285|NCT02696785|Secondary|Change From Baseline in Chest Expansion|"While participants have their hands resting on or behind the head, the assessor has measured the chest's encircled length by centimeter at the fourth intercostal level anteriorly. The difference between maximal inspiration and expiration in centimeters was recorded. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses.~LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All Randomized Participants.|||Centimeters (cm)||Standard Error|Least Squares Mean
2558286|NCT02696785|Secondary|Change From Baseline in Mobility on the Bath Ankylosing Spondylitis Metrology Index (BASMI)|"The BASMI is a combined index comprising the following 5 clinical measurements of spinal mobility in participants with rad-axSpA.~Lateral spinal flexion~Tragus-to-wall distance~Lumbar flexion (modified Schrober)~Maximal intermalleolar distance~Cervical rotation. The BASMI includes these 5 measurements that are each scaled to a score of 0 to 10 depending on the result of the assessment (BASMI linear function). The average score of the 5 assessments gives the BASMI linear result. The higher the BASMI score the more severe the participants limitation of movement due to their AS.~LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All randomized participants.|||score on a scale||Standard Error|Least Squares Mean
2558287|NCT02696785|Secondary|Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)|"High sensitivity CRP is the measure of acute phase reactant. It will be measured with a high sensitivity assay at the central laboratory to help assess the effect of Ixekizumab on disease activity.~LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, visit and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All randomized participants.|||Milliragm per Litre (mg/mL)||Standard Error|Least Squares Mean
2558288|NCT02696785|Secondary|Change From Baseline in ASAS Health Index (ASAS HI)|"ASAS HI is a disease-specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17-item instrument has scores ranging from 0 (good health) to 17 (poor health). Each item consists of one question that the participant needs to respond to with either I agree (score of 1) or I do not agree (score of 0). A score of 1 is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index.~LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors"|Baseline, Week 16|All randomized participants.|||score on a scale||Standard Error|Least Squares Mean
2558289|NCT02696785|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores|"The SF-36 is a 36-item participant administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The 2 overarching domains of mental well- being and physical well-being are captured by the Mental Component Summary and Physical Component Summary scores. T-scores are used for analysis. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.~LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All randomized participants.|||score on a scale||Standard Error|Least Squares Mean
2558290|NCT02696785|Secondary|Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] - Berlin Score)|"The Berlin modification of Ankylosing Spondylitis spine MRI score for activity (ASspiMRI) scoring technique assesses inflammation in each of 23 disco-vertebral units (DVU). All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) are scored for bone marrow edema. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema [less than or equal to 25% of DVU; 3=severe bone marrow edema (more that 50% of DVU)]. The composite score ranges from 0 to 69, with higher scores reflecting worse disease.~Least Squares (LS) Mean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors."|Baseline, Week 16|All randomized participants with baseline and week 16 Berlin score.|||score on a scale||Standard Error|Least Squares Mean
2558291|NCT02696785|Secondary|Percentage of Participants Achieving ASDAS Inactive Disease|"ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are the following:~Total back pain~Patient global~Peripheral pain/swelling~Duration of morning stiffness~CRP in mg/L The ASDAScrp is calculated with the following equation: 0.121 × total back pain + 0.110 × patient global + 0.073 × peripheral pain/swelling + 0.058 × duration of morning stiffness + 0.579 × Ln(CRP+1). CRP is in mg/liter, the range of other variables is from 0 to 10.Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. ASDAS Inactive Disease is defined as a score of <1.3."|Week 16|All randomized participants.|||percentage of Participants|||Number
2558292|NCT02696785|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)|"The BASFI is a participant-reported assessment that establishes a participants functional baseline and subsequent response to treatment. To complete the BASFI, a participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants respond to each question using an NRS scale (range 0 to 10) with a higher score indicating worse function. The participants final BASFI score is the mean of the 10 item scores has a possible minimum value of 0 and a possible maximum value of 10, with a higher score indicating worse function.~LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All randomized participants.|||score on a scale||Standard Error|Least Squares Mean
2558293|NCT02696785|Secondary|Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response|"The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis measuring discomfort, pain, and fatigue. 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. participants need to score each item with a score from 0 to 10 (NRS). total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem).~BASDAI50 represents an improvement of ≥50% of the BASDAI score from baseline."|Week 16|All randomized participants.|||percentage of participants|||Number
2558294|NCT02696785|Secondary|Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)|"ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are the following:~Total back pain~Patient global~Peripheral pain/swelling~Duration of morning stiffness~CRP in mg/L The ASDAScrp is calculated with the following equation: 0.121 × total back pain + 0.110 × patient global + 0.073 × peripheral pain/swelling + 0.058 × duration of morning stiffness + 0.579 × Ln(CRP+1). CRP is in mg/liter, the range of other variables is from 0 to 10.Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm.~Least Square (LS) Mean was calculated using mixed model repeated measures (MMRM) model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors."|Baseline, Week 16|All randomized participants.|||score on a scale||Standard Error|Least Squares Mean
2558295|NCT02696785|Secondary|Percentage of Participants Achieving an ASAS20 Response|"ASAS20 response is defined as a ≥20% improvement and an absolute improvement from baseline of ≥1 units in ≥3 of 4 following domains and no worsening of ≥20% and ≥1 unit (range 0 to 10) in the remaining domain.~Patient Global: How active was your spondylitis on average during the last week? score range 0 (not active) to 10 (very active).~Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).~Bath Ankylosing Spondylitis Functional Index: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants response is captured using NRS scale (range 0 to 10) with a higher score indicating worse function.~Inflammation based on Q5 & Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity & duration of stiffness): Score ranges from 0 (none) and 10 (very severe)."|Week 16|All randomized participants.|||percentage of participants|||Number
2558296|NCT02696785|Primary|Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response|"ASAS40 is defined as improvement from baseline of greater than or equal to (>=) 40% and absolute improvement from baseline of at least 2 units in at least 3 of the following 4 domains without any worsening in the remaining domains.~Patient Global: How active was your spondylitis on average during the last week? score range 0 (not active) to 10 (very active).~Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).~Bath Ankylosing Spondylitis Functional Index: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants response is captured using numeric rating scale (NRS) scale (range 0 to 10) with a higher score indicating worse function.~Inflammation based on Q5 & Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity & duration of stiffness): Score ranges from 0 (none) and 10 (very severe)."|Week 16|All Randomized participants.|||percentage of participants|||Number
2558297|NCT02696434|Secondary|Incidence of Adverse Events (AEs)|Number and percentage of subjects who experienced AEs.|Up to 42 days|There is one subject who was randomized to the naltrexone + buprenorphine treatment arm, but mistakenly received placebo naltrexone + buprenorphine treatment. All the efficacy analyses are summarized by the planned treatment assignment, and all the safety analyses are summarized by actual treatment.|||Participants|||Count of Participants
2558298|NCT02696434|Secondary|"Mean Score for Desire for Opioids Visual Analog Scale (VAS) During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period"|"The Desire for Opioids VAS uses a 100-mm, horizontal linear scale, with 0 anchored on the left representing no desire for opioids and 100 anchored on the right representing strongest imaginable desire for opioids."|Up to 11 days|All randomized subjects who received at least 1 dose of study drug and provided at least 1 post-baseline measureable VAS assessment.|||score on a scale||Standard Deviation|Mean
2558299|NCT02696434|Secondary|Area Under the Curve (AUC) for COWS Scores During the Treatment Period and VIVITROL Induction and Post-VIVITROL Observation Period|The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal). The daily AUC COWS score is derived based on the actual time (unit in minutes) COWS administered on each day by using the linear trapezoidal rule, and then divided by the COWS administration duration (last COWS administration time minus first COWS administration time) for that day. The normalized AUC COWS score is the summation of daily AUC COWS score during the relevant period divided by the number of days with daily AUC COWS score.|The COWS was administered 4-6 times per day during the Treatment Period|There is one subject who was randomized to the naltrexone + buprenorphine treatment arm, but mistakenly received placebo naltrexone + buprenorphine treatment. This subject is categorized in the PBO NTX+BUP arm in the participant flow and safety analyses, but in the efficacy analyses the subject is categorized as NTX+BUP.|||score on a scale||Standard Deviation|Mean
2558300|NCT02696434|Secondary|Mean Peak COWS Scores During the Treatment Period (Days 1/1a-7)|The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal).|Up to 7 days|There is one subject who was randomized to the naltrexone + buprenorphine treatment arm, but mistakenly received placebo naltrexone + buprenorphine treatment. This subject is categorized in the PBO NTX+BUP arm in the participant flow and safety analyses, but in the efficacy analyses the subject is categorized as NTX+BUP.|||score on a scale||Standard Deviation|Mean
2562456|NCT02638259|Secondary|Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48;||week 36 and week 48|Treatment period 2 per protocol set. Patients with data available|||Participants|||Count of Participants
2558301|NCT02696434|Secondary|Proportion of Post-VIVITROL Days (Days 9-11) in Which Subjects in Each Group Demonstrate Mild Opioid Withdrawal|COWS score </=12; The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal).|Days 9-11|There is one subject who was randomized to the naltrexone + buprenorphine treatment arm, but mistakenly received placebo naltrexone + buprenorphine treatment. This subject is categorized in the PBO NTX+BUP arm in the participant flow and safety analyses, but in the efficacy analyses the subject is categorized as NTX+BUP.|||Days||Standard Deviation|Mean
2558302|NCT02696434|Secondary|Proportion of Days With COWS Peak Score </=12 During the Treatment Period Prior to the VIVITROL Injection|The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal).|1 week|There is one subject who was randomized to the naltrexone + buprenorphine treatment arm, but mistakenly received placebo naltrexone + buprenorphine treatment. This subject is categorized in the PBO NTX+BUP arm in the participant flow and safety analyses, but in the efficacy analyses the subject is categorized as NTX+BUP.|||Days||Standard Deviation|Mean
2558303|NCT02696434|Primary|Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection on Day 8|Demonstrated by mild opioid withdrawal symptoms (Clinical Opiate Withdrawal Scale [COWS] </=12 or Subjective Opiate Withdrawal Scale [SOWS] </=10) following VIVITROL administration. The COWS is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal). The SOWS is a 16-item self-report questionnaire designed to measure the severity of opioid withdrawal symptoms. The subject rates the intensity of symptoms using a 5-point scale. The range of SOWS scores is 1-10 (mild); 11-20 (moderate); and 21-30 (severe).|8 days|There is one subject who was randomized to the naltrexone + buprenorphine treatment arm, but mistakenly received placebo naltrexone + buprenorphine treatment. This subject is categorized in the PBO NTX+BUP arm in the participant flow and safety analyses, but in the efficacy analyses the subject is categorized as NTX+BUP.|||Participants|||Count of Participants
2558304|NCT02696317|Secondary|Pre-Lens Tear Film MPA After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)|MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed following 6 hours of wear including 3 hours in a reduced humidity environment (20% RH).. Higher values indicate less dry and more eye comfort.|Day 10 ± 3 days, each product|Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.|||percentage of contact lens surface area|Eyes|Standard Deviation|Mean
2558305|NCT02696317|Secondary|Pre-Lens Tear Film Minimum Protected Area (MPA) in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)|MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed in a normal environment following 3 hours of wear. Higher values indicate less dry and more eye comfort.|Day 10 ± 3 days, each product|Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.|||percentage of contact lens surface area|Eyes|Standard Deviation|Mean
2558306|NCT02696317|Secondary|Tear Film Evaporation Rate After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH)|Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 6 hours of lens wear, including 3 hours of wear in a 20% reduced humidity environment (20% RH), after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.|Day 10 ± 3 days, each product|Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.|||10^-7g/cm^2/s|Eyes|Standard Deviation|Mean
2558307|NCT02696317|Primary|Tear Film Evaporation Rate in a Normal Environment After 10 ± 3 Days of Wear (Pre RH)|Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 3 hours of wear in a normal environment after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.|Day 10 ± 3 days, each product|Full Analysis Set. Number Analyzed is the number of eyes with non-missing response.|||10^-7g/cm^2/s|Eyes|Standard Deviation|Mean
2558308|NCT02696291|Secondary|Accumulation Ratio (AR)|Accumulation Ratio (AR) Day 1/Day 7|Day 7|Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2558309|NCT02696291|Secondary|Apparent Terminal Half Life (t1/2)|Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of t1/2 are derived from individual subject plasma concentration-time data, calculated as ln2/λz. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7.|Day 7|Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug.|||h||Full Range|Median
2558310|NCT02696291|Secondary|Apparent Volume of Distribution of UV-4 During the Terminal Phase (Vz/F) After Multiple Doses|Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of Vz/F are derived from individual subject plasma concentration-time data, calculated as CL/F divided by λz. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7.|Day 7|Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug.|||L||Geometric Coefficient of Variation|Geometric Mean
2558311|NCT02696291|Secondary|Apparent Systemic Clearance (CL/F) at Steady State|Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of CL/F are derived from individual subject plasma concentration-time data, calculated as dose (free-base equivalent) divided by AUC(0-8). Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7.|Day 7|Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2558312|NCT02696291|Secondary|Area Under the Concentration-time Curve From Time Zero (Predose) Until 8 Hours After the Final Dose [AUC(0-8)]|Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of AUC(0-8) are derived from individual subject plasma concentration-time data, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, and 8 hrs after the first dose on Day 1; and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7.|Day 1, Day 7|Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2558313|NCT02696291|Secondary|Total Daily Exposure at Steady State: Area Under the Concentration-time Curve From Time Zero (Predose) Until 24 Hours After the Last Dose [AUC(0-24)]|Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of AUC(0-24) are derived from individual subject plasma concentration-time data, calculated as AUC(0-8) x 3 (Day 7 last dose only). Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7.|Day 7|Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2558314|NCT02696291|Secondary|Area Under the Concentration-time Curve From Time Zero (Predose) to Time of the Last Quantifiable Concentration After the Last Dose [AUC(0-last)]|Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of AUC(0-last) are derived from individual subject plasma concentration-time data, calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7.|Day 7|Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2558315|NCT02696291|Secondary|Time of Maximum Plasma Concentration (Tmax)|Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of tmax are derived from individual subject plasma concentration-time data. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, and 8 hrs after the first dose on Day 1; and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7.|Day 1, Day 7|Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug.|||h||Standard Deviation|Mean
2558316|NCT02696291|Secondary|Maximum Plasma Concentration (Cmax)|Plasma concentrations of UV-4 are determined by means of high performance liquid chromatography/tandem mass spectrometric assay. Values of Cmax are derived from individual subject plasma concentration-time data. Blood collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, and 8 hrs after the first dose on Day 1; and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 5, 6, 8, 10, 12, and 14 hrs after the final dose on Day 7.|Day 1, Day 7|Pharmacokinetic Population: all subjects who received study product, had measurable values, and completed scheduled postdose pharmacokinetic measurements without protocol deviations or events thought to significantly affect the pharmacokinetics of the drug.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2558317|NCT02696291|Secondary|Number of Subjects With 12-lead Electrocardiogram (ECG) Abnormalities Postdose by Group|ECGs (ventricular heart rate, wave intervals - PR, QRS, QT, QTcF) were recorded in a supine position (for at least 10 minutes). Baseline was calculated from the average of the triplicate ECGs on Day 1 predose. Within each parameter, subjects having multiple abnormalities are counted only once.|From the time of first dosing on Day 1 through the Day 15 final follow-up visit|Safety Population: all subjects who received at least one dose of study product or placebo.|||Participants|||Count of Participants
2558318|NCT02696291|Secondary|Number of Subjects With Outlying Vital Sign Results by Group|Vital signs of blood pressure (BP), pulse, respiratory rate, and oral temperature were taken after being supine for 10 minutes. Orthostatic vital signs (BP, pulse) were taken after 2 minutes standing. Vital sign results are presented as the number of subjects having Grade 1 (mild) through Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the FDA Guidance for Industry, Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007), or having abnormal orthostatic change (standing minus supine result). Within each parameter, subjects having multiple abnormalities are counted only once.|From the time of first dosing on Day 1 through the Day 15 final follow-up visit|Safety Population: all subjects who received at least one dose of study product or placebo.|||Participants|||Count of Participants
2558319|NCT02696291|Primary|Number of Subjects With Clinical Laboratory Abnormalities of Toxicity Grade 1 or Higher by Group|Clinical laboratory abnormalities are presented as the total of Grade 1 (mild) through Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the Food and Drug Administration (FDA) Guidance for Industry, Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007) and the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table (November 2007). Within each parameter, subjects having multiple abnormalities are counted only once.|From the time of first dosing on Day 1 through the Day 15 final follow-up visit|Safety Population: all subjects who received at least one dose of study product or placebo.|||Participants|||Count of Participants
2558320|NCT02696291|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs) by Group|The incidence of SAEs spontaneously reported by subjects or elicited during examination is reported by dose group. Subjects having multiple SAEs are counted only once.|From the time of first dosing on Day 1 through the Day 15 final follow-up visit|Safety Population: all subjects who received at least one dose of study product or placebo.|||Participants|||Count of Participants
2558321|NCT02696291|Primary|Number of Subjects Reporting Treatment-emergent Adverse Events (TEAEs) by Group|The incidence of TEAEs spontaneously reported by subjects or elicited during examination is reported by dose group. Subjects having multiple TEAEs are counted only once.|From the time of first dosing on Day 1 through the Day 15 final follow-up visit|Safety Population: all subjects who received at least one dose of study product or placebo.|||Participants|||Count of Participants
2558322|NCT02696226|Primary|Leaflet Motion|Frequency of reduced leaflet motion related to perioperative anticoagulation with warfarin as measured by 4DMCT data. (<50% reduction in motion), moderately reduced (50 to 70% reduction), severely reduced (>70% reduction), or immobile (lack of motion of at least one valve leaflet).|4-6 weeks post procedure|Study terminated||||||
2558323|NCT02696083|Primary|Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90|Synovial markers measured included bone morphologic proteins, related proteins Activin A, Osteoactivin, sonic hedgehog, Dickkopf, interleukin cytokines and tumor necrosis factor alpha, Growth Factors and Related Proteins fibroblast growth factors 1,2, androgen receptor, platelet derived growth factor BB, tumor growth factor beta, osteprogenerin, osteopontin, and Insulin like growth factor-1. Inflammation related proteins assayed were monocyte chemoattractant protein-1, macrophage colony-stimulating factor, macrophage inflammatory protein, receptor activator of Nuclear factor κ, and TNF related activation induced cytokine. Adhesion and matrix metalloproteinase proteins levels were also determined. The mean protein concentration was calculated for these markers at Baseline (n=19), Day 45 (n=7) and Day 90 (n=6).|Baseline, Days 45 and 90|The mean protein concentration was calculated for these markers at Baseline (n=19), Day 45 (n=7) and Day 90 (n=6).|||protein markers|protein markers||Count of Units
2558324|NCT02696070|Primary|Changes in Small Nerve Fiber Density by Assessment of a Skin Biopsy Comparing Baseline to Day 60|The mean percent change in intraepidermal nerve fiber density mean values for mean nerve fibers per millimeter squared from baseline to Day 60 was calculated for each treatment group (value at 60 days minus value at baseline).|60 days||||nerve fibers / mm squared||Standard Deviation|Mean
2558325|NCT02695719|Secondary|Weekly Responder Rate|"The responder rate was assessed each week and was derived from the data on SBMs collected in the diary. A non-responder was defined as any participant with a spontaneous BM frequency rate of less than 3 for a given week, any participant who dropped out during or before the given week due to lack of efficacy, or any participant who used rescue medication during or within 24 hours before the given week. Otherwise, the participant subject was considered a responder.~A responder with a spontaneous BM frequency rate ≥3 but <4 was considered a moderate responder. Otherwise, the participant was a full responder (≥4 SBM)."|Weeks 1, 2, 3 and 4|FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method.|||percentage of participants|||Number
2558326|NCT02695719|Secondary|Weekly Abdominal Symptoms Score|The abdominal symptoms (bloating and discomfort upon waking in the morning) were scored weekly on a 5-point scale, where: 0=None, 1=Mild, 2=Moderate, 3=Severe or 4=Very severe, with a higher score indicating more severe symptoms. Assessment of weekly abdominal symptoms were recorded by the participant in the diary.|Weeks 1, 2, 3 and 4|FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method.|||scores on a sclae||Standard Deviation|Mean
2558327|NCT02695719|Secondary|Mean Degree Stool Consistency Score|For each participant, the mean stool consistency score was averaged for all SBMs in a given week. The mean degree of stool consistency for each SBM was collected in the participant diary based on the Bristol Stool Chart. The Bristol Stool Chart is a visual medical aid designed to classify the form of human feces into seven categories where: 1=Hard and round (difficult-to-pass), 2=Sausage-shaped but hard stool, 3=Sausage-shaped stool with cracks on the surface, 4=Sausage-shaped, soft stool with smooth surface, or coiled stool, 5=Soft, half-solid (and easy-to-pass) stool with clear crease, 6=Unshaped, loose stool with small, irregular-shaped pieces, or mushy stool or 7=Watery stool without solid pieces (entirely liquid).|Weeks 1, 2, 3 and 4|FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method.|||scores on a scale||Standard Deviation|Mean
2558328|NCT02695719|Secondary|Mean Degree of Straining Score|For each participant, the mean degree of straining was averaged for all SBMs in a given week. The degree of straining for each SBM was collected in the participant diary. The degree of straining is scored on a 5-point scale where: 0=No straining, 1=Mild straining, 2=Moderate straining, 3=Strong straining or 4=Very strong straining with higher scores indicating more severe straining.|Weeks 1, 2, 3 and 4|FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method.|||scores on a scale||Standard Deviation|Mean
2558329|NCT02695719|Secondary|Percentage of Participants Who Had a SBM Within 24 Hours After the First Dose of Study Medication|A SBM was defined as any BM that does not occur within 24 hours after rescue medication use. Percentage of participants who have an SBM within 24 hours after the first dose will be assessed and derived from the data on SBMs collected in the participant diary.|Up to 24 hours after the first dose of study medication|FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Here, number of participants analyzed is the participants who were evaluated for this outcome measure.|||percentage of participants|||Number
2558331|NCT02695719|Primary|Spontaneous Bowel Movement (SBM) Frequency at Week 1|A SBM was defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants will be given a diary to complete at home where they will record all details of each SBM including the consistency of the stool and the difficulty they have in passing it.|Week 1|FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by last observation carried forward (LOCF) method.|||SBMs/week||Standard Deviation|Mean
2558332|NCT02695628|Secondary|Adverse Events Related to 18F-fluoromisonidazole (18F-FMISO)|Toxicity to 18F-fluoromisonidazole (18F-FMISO) was assessed by the number of adverse events that occurred within 18 hours of administration (about 10 half-lives), that were also unanticipated and related to 18F-FMISO. The outcome is reported as the number of adverse events that were unanticipated and related to 18F-FMISO, a number without dispersion.|18 hours|All participants are included for this outcome.|||Number of adverse events|||Number
2558333|NCT02695628|Secondary|Maximum Standardized Uptake Value (SUVmax) at Lesion Sites With and Without Tumor Recurrence|Follow-up 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET)/computed tomography (CT) scans were to be conducted within 6 months or at the time of tumor recurrence. Maximum standardized uptake value (SUVmax) were determined at the tumor lesion and in normal tissue, represented by liver. The variability of 18F-FMISO uptake at the hepatocellular carcinoma (HCC) tumor lesion site post-TACE was assessed as the mean difference in the ratio of the SUVmax as observed in the tumor vs liver (tumor-to-liver ratio, TLR), between lesions that recurred, and those that did not. The outcome is reported as the mean TLR, with standard deviation.|Up to 6 months|Follow-up 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET) scans at the time of tumor recurrence were not conducted.||||||
2558334|NCT02695628|Primary|Post-treatment Maximum Standardized Uptake Value (SUVmax) in Tumor and Normal Tissue|All participants undergo transcatheter arterial embolization (TACE) and 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET)/computed tomography (CT) scans were conducted. Maximum standardized uptake value (SUVmax) were determined at the tumor lesion and in normal tissue, represented by liver. The variability of 18F-FMISO uptake in hepatocellular carcinoma (HCC) tumors post-TACE was assessed as the ratio of the SUVmax as observed in the tumor vs liver (tumor-to-liver ratio, TLR). The outcome is reported as the mean TLR, with standard deviation.|24 hours|Due to withdrawal, not all participants completed for this outcome.|||Ratio||Standard Deviation|Mean
2558335|NCT02695537|Secondary|Change in Seizure Severity Measured by the Chalfont Seizure Severity Scale (Duncan & Sander, 1991, JNNP).|Seizure severity was collected during study clinic and phone visits using the Chalfont Seizure Severity Scale (CSSS) (Duncan & Sander, 1991, JNNP) through verbal reporting. The CSSS measured components of seizures most disturbing or disruptive to the participants. The total scores for a given seizure type was its severity score. High scores indicated high severity of the seizures (no fixed maximum value), while a score of zero indicated low severity. Scores were recorded and stored in the UAB RedCap System. The analysis plan was to assess the pattern of change in seizure severity scores over time, relative to baseline, following CBD exposure. Since the baseline measure was reported at the time of screening, there was some tendency to overestimate the severity of seizures in the historically reported interval. This was examined by comparing the initial study visits improvement versus the pattern of control over time, and was assessed using graphic techniques and summary statistics.|For 1 Year following Enrollment|Per protocol, after all participants have been enrolled and followed for 1 year. Number of participants analyzed differed because: 1) Those who responded to a certain CBD dose had fewer monthly visits; 2) Those who decided to continue on the same CBD dose had fewer monthly visits; or 3) Withdrawal prior to 1 year following enrollment.|||scores on a scale||95% Confidence Interval|Geometric Least Squares Mean
2558336|NCT02695537|Secondary|Change in Seizure Frequency as Measured in Total Number of Seizures Per Month.|Participants were given seizure diary logs and dairy data collection was done at study clinic visits. Data was recorded and stored in the UAB RedCap System. The analysis plan was to assess the pattern of change in seizure frequency over time, relative to baseline, following CBD exposure. Since the baseline measure was reported at the time of screening, there was some tendency to overestimate the frequency of seizures in the historically reported interval. This was examined by comparing the initial study visits improvement versus the pattern of control over time, and was assessed using graphic techniques and summary statistics.|For 1 Year following Enrollment|Per protocol, after all participants have been enrolled and followed for 1 year. Number of participants analyzed differed because: 1) Those who responded to a certain CBD dose had fewer monthly visits; 2) Those who decided to continue on the same CBD dose had fewer monthly visits; or 3) Withdrawal prior to 1 year following enrollment.|||number of seizures/month||95% Confidence Interval|Geometric Least Squares Mean
2558337|NCT02695537|Primary|Number of Participants With Change in Laboratory Tests Considered by Managing Neurologists as Clinically Significant.|During study clinic visits, participants received laboratory testing to assess for side effects and toxicity. Data was recorded and stored in the UAB RedCap System. Laboratory testing included Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP; included Liver Function Tests (LFTs) mainly looking at alanine aminotransferase (ALT) and aspartate aminotransferase (AST)), Urine Analysis (UA), and Antiepileptic Drug (AED) levels. Clinically significant was determined by using the Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03. Adverse events categorized as a grade 3 or above were considered clinically significant. Adverse events grade 4 or above were considered severe adverse events.|For 1 Year following Enrollment|Per protocol, after all participants have been enrolled and followed for 1 year.|||Participants|||Count of Participants
2558338|NCT02695537|Primary|Number of Participants With Change in Resting Blood Pressure or Heart Rate by 25% if Considered Significant by Managing Neurologist.|During study clinic visits, participant vital signs, including blood pressure and heart rate, were collected. Data was recorded and stored in the UAB RedCap System. Clinically significant was determined by using the Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03. Adverse events categorized as a grade 3 or above were considered clinically significant. Adverse events grade 4 or above were considered severe adverse events.|For 1 Year following Enrollment|Per protocol, after all participants have been enrolled and followed for 1 year.|||Participants|||Count of Participants
2558825|NCT02688764|Secondary|Ferritin Values at Each Time Point and Change From Baseline||From baseline through study completion, up to 34 weeks after treatment start date|Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received|||ug/L||Standard Deviation|Mean
2558339|NCT02695537|Primary|Number of Participants With Severe Adverse Events (Increase in Seizure Frequency by More Than 100% Leading to Emergency Room Visit or Hospitalization).|Severe adverse events (SAEs) were defined as increase in seizure frequency by more than 100% leading to emergency room visit or hospitalization. During study clinic and phone visits, adverse and severe adverse event monitoring and reporting were assessed among all participants. Data was recorded and stored in the UAB RedCap System.|For 1 Year following Enrollment|Per protocol, after all participants have been enrolled and followed for 1 year.|||Participants|||Count of Participants
2558340|NCT02695524|Secondary|Scapula Position Evaluated by Digital Inclinometer and the Measures Provided in Degrees|upward rotation and tilt of the scapula|baseline, four and eight weeks and sixteen weeks after randomization||||degrees||95% Confidence Interval|Mean
2558341|NCT02695524|Secondary|Satisfaction With Treatment Evaluated With Specific Questionnaire|Medrisk Questionnaire ranging 13 to 80 points. High scores indicate satisfaction with treatment|four, eight weeks and sixteen weeks after randomization||||units on a scale||95% Confidence Interval|Mean
2558342|NCT02695524|Secondary|Range of Motion Evaluated by Digital Inclinometer and the Measures Provided in Degrees|abduction, adduction, internal and external rotation of the shoulder|baseline, four and eight weeks and sixteen weeks after randomization||||degrees||95% Confidence Interval|Mean
2558343|NCT02695524|Secondary|Change in Kinesiophobia Evaluated With Specific Questionnaire|Tampa Scale of Kinesiophobia ranging 17 to 68 points. High scores indicate high degree kinesiophobia|baseline, four and eight weeks and sixteen weeks after randomization||||units on a scale||95% Confidence Interval|Mean
2558344|NCT02695524|Secondary|Perceived Change Evaluated by Numerical Scale|Global Perceived Effect Scale ranging -5 to +5 points. Positive values indicate improvement and negative values indicate worsening of symptoms|four, eight weeks and sixteen weeks of randomization||||units on a scale||95% Confidence Interval|Mean
2558345|NCT02695524|Secondary|Change in Strength Evaluated by Hand Held Dynamometer and the Measures Provided in Kilogram-force (KgF)|Strength of serratus anterior, trapezius muscles, abduction, adduction, internal and external rotation movements the arm with hand held Dynamometer.|baseline, four and eight weeks and sixteen weeks after randomization||||Kilogram-force||95% Confidence Interval|Mean
2558346|NCT02695524|Secondary|Change in Intensity of Pain Evaluated by a Scale|Pain Numerical Rating Scale from 0 to 10. Lower values indicate improvement in pain|baseline, four and eight weeks and sixteen weeks after randomization||||units on a scale||95% Confidence Interval|Mean
2558347|NCT02695524|Primary|Change in Functionality Evaluated With Specific Questionnaire|The Brazilian version of Shoulder Pain and Disability Index ranging 0 to 100 points. Lower scores indicate better functionality|baseline, four and eight weeks and sixteen weeks after randomization||||units on a scale||95% Confidence Interval|Mean
2558348|NCT02695446|Secondary|Skin/Dermal Levels of Minocycline||Measured at 2 weeks in half the subjects, 4 week biopsies not performed per early stopping rules||||ng/ml||Full Range|Mean
2558349|NCT02695446|Primary|Plasma Minocycline Level||Assessed at week 2 and week 4; reported at week 4||||ng/ml||Standard Deviation|Mean
2558350|NCT02695420|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is defined as any untoward medical occurrence. Serious AEs are defined as AEs that meets at least 1 of the following serious criteria: fatal, life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, other medically important serious event. AEs are graded as: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death. TEAEs are defined as events occurring after the first dose of study drug.|From first dose of study drug up to Week 20 (Day 140 + 3 days)|Safety Analysis Set: all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2558351|NCT02695420|Secondary|Change From Baseline at Week 16 in Systolic Ejection Time (SET)|LS mean was from the repeated measures model, which included treatment group, stratification factor (from IVRS), scheduled visit, baseline value, and the interaction of treatment group with scheduled visit as covariates.|Baseline, Week 16 (Day 112)|All participants who received at least one dose of study drug with observed data. The 4 active treatment arms include only those participants who had a minimum investigational product exposure period of 25 days.|||msec||Standard Error|Least Squares Mean
2558352|NCT02695420|Primary|PK: Area Under the Curve Until 8 Hours After Morning Dose at Week 8 (AUC0-8)||Week 8 (Day 56) at predose, at 2 hours ±30 minutes; 4 hours ±30 minutes; 6 hours ±30 minutes; 8 hours ±30 minutes after morning dose|PK Analysis Set: all randomized participants who received at least one dose of omecamtiv mecarbil and had at least one evaluable omecamtiv mecarbil PK concentration.|||hr*ng/mL||Standard Deviation|Mean
2558353|NCT02695420|Primary|Pharmacokinetics (PK): Concentration Before Morning Dose (Cpredose) Over Time||Before morning dose on Week 2 (Day 15), Week 4 (Day 28), Week 12 (Day 84), Week 16 (Day 112)|PK Analysis Set: all randomized participants who received at least one dose of omecamtiv mecarbil and had at least one evaluable omecamtiv mecarbil PK concentration at given time point.|||ng/mL||Standard Deviation|Mean
2558354|NCT02695329|Secondary|Number of Participants With Adverse Events and/or Adverse Device Effects|Number of participants, who experience adverse events and/or adverse device effects|Intra-operative and Post-operative 6 months||||Participants|||Count of Participants
2558355|NCT02695329|Secondary|Number of Participants With Femoral Varus/Valgus Angle Within Predetermined Threshold|Deviation of femoral valus/valgus angle from preoperative planned angle (within 2 degrees)|Postoperative 6 months||||Participants|||Count of Participants
2558356|NCT02695329|Secondary|Number of Participants With Tibial Posterior Slope Alignment Within Predetermined Threshold|Deviation of tibial posterior slope angle from preoperative planned angle (within 2 degrees)|Postoperative 6 months||||Participants|||Count of Participants
2558357|NCT02695329|Primary|Proportion of Subjects That Have Alignment Within 2 Degrees From Neutral on Tibia|Proportion of subjects that have tibial alignment within 2 degrees from neutral and compare the accuracy of tibial component alignment between two groups.|Postoperative 6 months||||Participants|||Count of Participants
2558474|NCT02692482|Secondary|Number of Participants With Skin Irritation/Damage Due to the Adhesive Dressing|Clinical evaluation. It refers to any sort of inflammation and/or discoloration that distorts the skin's normal appearance. The skin may become scaly, bumpy, itchy, or otherwise irritated.|On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.||||Participants|||Count of Participants
2558359|NCT02695290|Secondary|Percentage of Patients With Occurrence of CTCAE Grade 3 or Higher Diarrhoea, Rash/Acne+, Stomatitis+ and Paronychia+ (+ Represents Grouped Term)|Percentage of patients with occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher diarrhoea, rash/acne+, stomatitis+ and paronychia+ (+ represents grouped term).|Up to 98 days|Patients who receive at least one dose of afatinib will be included in the treated set.All data collected from the single patient who received study medication. All data collected from the single patient who received study medication.|||Percentage of Participants|||Number
2558360|NCT02695290|Primary|Percentage of Patients With Occurrence of Adverse Events (AEs) Leading to Dose Reduction of Afatinib|Percentage of patients with occurrence of Adverse Events (AEs) leading to dose reduction of afatinib.|Up to 98 days|Patients who receive at least one dose of afatinib will be included in the treated set.All data collected from the single patient who received study medication.|||Pecentage of Participants||95% Confidence Interval|Number
2558361|NCT02694978|Secondary|Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5|Mean change in hemoglobin per g of iron administered from Baseline (Day 1) to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.|Baseline (Day 1), Week 5|ITT population: any randomized participant who had any exposure to study drug, based on randomized treatment assignment.|||g/dL||Standard Deviation|Mean
2558362|NCT02694978|Secondary|Mean Change In Hemoglobin From Baseline To Week 5|Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.|Baseline (Day 1), Week 5|Intent-to-treat (ITT) population: any randomized participant who had any exposure to study drug, based on randomized treatment assignment.|||g/dL||Standard Deviation|Mean
2558363|NCT02694978|Secondary|Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death|"All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC).~A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Day 1 (after first dosing) through Week 5|The safety population included any randomized participant who received any amount of study drug. Treatment group was based on actual treatment.|||Participants|||Count of Participants
2558364|NCT02694978|Primary|Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension|"All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). Hypotension is defined as a >30% drop in systolic blood pressure from baseline or decrease of >20 mmHg for systolic blood pressure.~Statistical analysis was only performed on composite data. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Day 1 (after first dosing) through Week 5|The safety population included any randomized participant who received any amount of study drug. Treatment group was based on actual treatment.|||Participants|||Count of Participants
2558365|NCT02694835|Primary|Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reported in units of eyes.|Day 1 at Hour 9 ± 3 hours|Full Analysis Set|||Eyes|Eyes||Count of Units
2558366|NCT02694757|Primary|Change in Readmission Rate|No outcomes were measured due to termination of study.|30 days post-operation|No analysis was completed due to termination of study.||||||
2558367|NCT02694744|Secondary|Mean Change in Serum Potassium From Baseline to Week 4|An ANCOVA model was used to estimate the mean serum potassium change from Baseline to Week 4 with baseline serum potassium as a covariate and treatment group, race (white vs all others), and history of Type 1 or 2 diabetes mellitus (yes or no) as factors in the model.|Baseline to Day 28|Only intent-to-treat subjects who were available at both Baseline and Week 4 visits.|||mEq/L||Standard Error|Least Squares Mean
2558368|NCT02694744|Primary|Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4||21 to 28 Days|The intent-to-treat (ITT) population for efficacy analyses includes all subjects who have been randomized and have taken at least one dose of patiromer.|||percentage of participants||95% Confidence Interval|Number
2558369|NCT02694718|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 16|Safety population included all the participants who received at least one dose of any of the study treatments and who had a baseline assessment.|||Participants|||Number
2558370|NCT02694718|Secondary|Percentage of Participants With Pathological Incomplete Tumor Response|Pathological incomplete tumor response was defined as grade 1 or 2 in the histological grading of regression according to Dworak grading of regression. Pathological incomplete tumor response rate, Grade 1: dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2: dominantly fibrotic changes with few tumor cells or groups (easy to find) were assessed.|Up to Week 16|ITT population included all participants, who received at least one dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
2558386|NCT02694562|Primary|Freedom From Serious Adverse Events Rate|Freedom from Serious Adverse Events reports the number of participants that did not have a serious adverse event reported within 30 days of treatment that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defects.|30 days||||Participants|||Count of Participants
2558371|NCT02694718|Secondary|Percentage of Participants With Downstaging of Primary Tumor and/or Lymph Nodes|Downstaging of primary tumor (T) and/or lymph nodes (N) was defined as decrease by 1 point in T-value and/or N-value (comparing at screening and after treatment). It was assessed by colonoscopy, pathology, endosonography of rectum, chest X-ray, abdominopelvic Computed Tomography and Magnetic Resonance Imaging. Staging for tumor are: TX (primary tumor cannot be assessed), T0 (no evidence of primary tumor), Tis (carcinoma in situ), T1 (tumor invades submucosa), T2 (tumor invades muscularis propria), T3 (tumor invades through muscularis propria into subserosa/into non-peritonealized pericolic/perirectal tissues, T4 (tumor directly invades other organs or structures). Staging for lymph nodes are: NX (regional lymph nodes cannot be assessed), N0 (no regional lymph node metastasis), N1 (metastasis in 1 to 3 regional lymph nodes), N2 (metastasis in 4 or more regional lymph nodes).|From screening to Week 16|ITT population included all participants, who received at least one dose of study drug.|||Percentage of participants|||Number
2558372|NCT02694718|Secondary|Percentage of Participants With Resection (R0) in Participants With T4 Rectal Cancer|R0 resection was defined as complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation as confirmed by pathology after pre-operative chemotherapy plus capecitabine + oxaliplatin therapy.|Up to Week 16|The ITT consists of all included participants, who received at least one dose of study drug. Five participants from ITT population with T4 rectal cancer underwent surgery.|||Percentage of participants|||Number
2558373|NCT02694718|Secondary|Number of Participants With Marked Laboratory Abnormalities|Number of participants with marked laboratory abnormalities is reported.|Up to Week 16|Safety population included all the participants who received at least one dose of any of the study treatments and who had a baseline assessment.|||Participants|||Number
2558374|NCT02694718|Secondary|Percentage of Participants With Sphincter-preservation|Percentage of participants with sphincter-preservation is reported.|Up to Week 16|ITT population included all participants, who received at least one dose of study drug. Two participants from the ITT population did not undergo surgery (one died, one withdrew consent).|||Percentage of participants|||Number
2558375|NCT02694718|Primary|Percentage of Participants With Pathological Complete Tumor Response|Pathological complete tumor response was defined as grade 3 or 4 in the histological grading of regression according to Dworak classification. Grade 0 is no regression; Grade 1 is dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2 is dominantly fibrotic changes with few tumor cells or groups; Grade 3 is defined as very few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance; Grade 4 is defined as no tumor cells, only fibrotic mass (total regression or response).|Up to Week 16|The intent to treat (ITT) population included all participants, who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2558376|NCT02694601|Secondary|Plasma Triglyceride Concentrations|Plasma triglycerides (mmol/L) measured over a 4 hour period.|4 hours||||mmol/L||Standard Error|Mean
2558377|NCT02694601|Secondary|Plasma Cholesterol Concentrations|Plasma cholesterol (mmol/L) measured over a 4 hour period.|4 hours||||mmol/L||Standard Error|Mean
2558378|NCT02694601|Secondary|Plasma Glucose Concentrations|Plasma glucose (mmol/L) measured over a 4 hour period.|4 hours||||mmol/L||Standard Error|Mean
2558379|NCT02694601|Primary|Plasma Beta-hydroxybutyrate Concentrations|Plasma beta-hydroxybutyrate (µmol/L) measured over a 4 hour period.|4 hours||||µmol/L||Standard Error|Mean
2558380|NCT02694601|Primary|Plasma Acetoacetate Concentrations|Plasma acetoacetate (µmol/L) measured over a 4 hour period.|4 hours||||µmol/L||Standard Error|Mean
2558381|NCT02694562|Secondary|Time To Tumor Progression|Time to Tumor Progression is defined as the time from the date of first study treatment to the day of documented disease progression or death due to any cause, whichever came first, assessed up to 1 year. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (mRECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 12 months post procedure|Two participants that did not have disease progression reported during the trial are not included in this analysis. One subject underwent liver resection surgery after their third study treatment and another subject’s tumor response was reported as stable disease prior to being lost to follow up after their third study treatment.|||days||Standard Deviation|Mean
2558382|NCT02694562|Secondary|Survival Rate|Number of participants that were alive 12 months after their first study treatment.|12 months post procedure||||Participants|||Count of Participants
2558383|NCT02694562|Primary|Local Tumor Control|Local tumor control reports the percent of subjects for which the size of the tumor does not increase. Local Tumor Control is defined as subjects having complete response or stable disease. For these subjects the treated tumor either shrinks or stays the same size when measuring the tumor using a standard tumor measurement guideline (based on the devascularization pattern from the European Association for the Study of the Liver (EASL) criteria).|12 months post procedure|All subjects were included in this analysis except for one subject that was removed from the study after undergoing liver resection surgery.|||Participants|||Count of Participants
2558384|NCT02694562|Primary|Local Tumor Control|Local tumor control reports the percent of subjects for which the size of the tumor does not increase. Local Tumor Control is defined as subjects having complete response or stable disease. For these subjects the treated tumor either shrinks or stays the same size when measuring the tumor using a standard tumor measurement guideline (based on the devascularization pattern from the European Association for the Study of the Liver (EASL) criteria).|6 months post procedure|All subjects were included in this analysis except for one subject that was removed from the study after undergoing liver resection surgery.|||Participants|||Count of Participants
2558385|NCT02694562|Primary|Local Tumor Control|Local tumor control reports the percent of subjects for which the size of the tumor does not increase. Local Tumor Control is defined as subjects having complete response or stable disease. For these subjects the treated tumor either shrinks or stays the same size when measuring the tumor using a standard tumor measurement guideline (based on the devascularization pattern from the European Association for the Study of the Liver (EASL) criteria).|3 months post procedure|All subjects were included in this analysis except for one subject that was removed from the study after undergoing liver resection surgery.|||Participants|||Count of Participants
2558387|NCT02694549|Secondary|Secondary Safety Endpoint|Safety: Incidence of all adverse events at 30 days|30 days||||Participants|||Count of Participants
2558390|NCT02694536|Secondary|Progression-Free Survival (PFS) According to RECIST|Tumor assessments were performed using RECIST. PFS was defined as the time from treatment start to the time of death or disease progression. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to smallest sum of LD on study. PFS was estimated by Kaplan-Meier methodology and expressed in months.|Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)|"Safety Population. The Number of Participants Analyzed reflects the number of participants who contributed to the endpoint."|||months||95% Confidence Interval|Median
2558391|NCT02694536|Secondary|Percentage of Participants With Death or Disease Progression According to Response Evaluation Criteria in Solid Tumors (RECIST)|Tumor assessments were performed using RECIST. Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of longest diameters (LD) of target lesions in reference to smallest sum of LD on study. The percentage of participants who died or demonstrated disease progression was reported to the nearest integer.|Up to approximately 40 months (assessed at Baseline, every 8 weeks during treatment, and end of study)|"Safety Population. The Number of Participants Analyzed reflects the number of participants who contributed to the endpoint."|||percentage of participants|||Number
2558392|NCT02694536|Secondary|Overall Survival (OS)|OS was defined as the time from start of treatment to time of death from any cause. Participants who had not died at the time of final analysis were censored at the date of last contact. OS was estimated by Kaplan-Meier methodology and expressed in months.|Up to approximately 40 months (assessed continuously through end of study)|"Safety Population. The Number of Participants Analyzed reflects the number of participants who contributed to the endpoint."|||months||95% Confidence Interval|Median
2558393|NCT02694536|Secondary|Percentage of Participants Who Died|The percentage of participants who died from any cause was reported to the nearest integer.|Up to approximately 40 months (assessed continuously through end of study)|"Safety Population. The Number of Participants Analyzed reflects the number of participants who contributed to the endpoint."|||percentage of participants|||Number
2558394|NCT02694536|Secondary|European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Item Scores|"The QLQ-C30 is a 30-item questionnaire that assesses physical (Questions 1-5), role (Questions 6-7), emotional (Questions 21-24), cognitive (Questions 20 and 25), and social (Questions 26-27) functional domains as well as global health status (Questions 29-30) and several symptoms including fatigue (Questions 10, 12, and 18), pain (Questions 9 and 19), nausea/vomiting (Questions 14-15), dyspnea (Question 8), appetite loss (Question 13), insomnia (Question 11), constipation/diarrhea (Questions 16-17), and financial difficulties (Question 28). Questions 1 to 28 were assessed on a 4-point scale from 1 (no/not at all) to 4 (very much) where higher scores represented worse symptoms. Questions 29 and 30 were assessed on a 7-point scale from 1 (very poor) to 7 (excellent) where higher scores represented better functioning. Item scores over the study period were averaged among all participants across all visits for which data were available."|Up to approximately 40 months (assessed at Baseline, every 4 weeks during treatment, and end of study)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who contributed to the endpoint. The number of responses for each questionnaire item combined across all assessments (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
2558395|NCT02694536|Primary|Percentage of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence and which did not necessarily have a causal relationship with treatment. The percentage of participants who experienced at least 1 AE was reported.|Up to approximately 40 months (assessed continuously during treatment)|Safety Population|||percentage of participants|||Number
2558396|NCT02694523|Other Pre-specified|Percentage of Participants Who Were Rerandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA Score of Clear or Almost Clear at Week 44 (Part B)|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 44|ITT_B_RR population|||percentage of participants|||Number
2558397|NCT02694523|Secondary|Percentage of Participants Who Were ReRandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving sPGA Score of Clear at Week 44 (Part B)|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 44|ITT_B_RR population|||percentage of participants|||Number
2558398|NCT02694523|Secondary|Percentage of Participants Who Were Rerandomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI100 at Week 44 (Part B)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 44|ITT_B_RR population|||percentage of participants|||Number
2558399|NCT02694523|Secondary|Percentage of Participants Achieving PASI100 at Week 16 (Part A)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 16|ITT_A population|||percentage of participants|||Number
2558400|NCT02694523|Secondary|Percentage of Participants Achieving PASI75 at Week 16 (Part A)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 16|ITT_A population|||percentage of participants|||Number
2558401|NCT02694523|Primary|Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 44|Intent-to-treat population in Part B who were re-randomized (ITT_B_RR): All subjects who started with adalimumab at Baseline and were re-randomized at Week 16|||percentage of participants|||Number
2558402|NCT02694523|Primary|Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A)|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 16|ITT_A population.|||percentage of participants|||Number
2558403|NCT02694523|Primary|Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.|Week 16|Intent-to-treat population in Part A (ITT_A): All subjects randomized at Baseline.|||percentage of participants|||Number
2558404|NCT02694328|Secondary|Number of Participants Experiencing of Adverse Events (AEs)||24 weeks|The Safety Population includes all randomized subjects who received at least 1 dose of study drug.|||Participants|||Count of Participants
2558405|NCT02694328|Secondary|Percentage of Participants With >/= 7% Weight Gain at Week 24||Baseline and Week 24|The FAS population included all randomized subjects who received at least 1 dose of study drug and had at least 1 postbaseline weight assessment.|||Percentage of participants|||Number
2558406|NCT02694328|Primary|Percentage of Participants With >/= 10% Weight Gain at Week 24||Baseline and Week 24|The FAS population included all randomized subjects who received at least 1 dose of study drug and had at least 1 postbaseline weight assessment.|||Percentage of participants|||Number
2558407|NCT02694328|Primary|Percent Change From Baseline in Body Weight at Week 24||Baseline and Week 24|The full analysis set (FAS) population includes all randomized subjects who received at least 1 dose of study drug and had at least 1 postbaseline weight assessment|||Percent change in body weight||Standard Error|Least Squares Mean
2558408|NCT02694315|Primary|Bishop Score Prior to Induction of Labor|"median Bishop score assessed by digital vaginal examination as follows:~Cervical dilatation in centimeters will be given a score of zero if closed, a score of 1 if 1-2 cm dilated, a score of 2 if 3-4 cm dilated and a score of 3 if 5 cm or more dilataion.~Effacement of the cervix will be given a score of zero if 0-30%, a score of 1 if 40-50%, a score of 2 if 60-70% and a score of 3 if 80% or more.~Station of fetal head will be given a score of zero if -3, a score of 1 if -2, a score of 2 if -1 to zero and a score of 3 if 1 or more.~Consistency of the cervix will be given a score of zero if firm, a score of 1 if medium and a score of 2 if soft.~Position of the cervix will be given a score of zero if posterior, a score of 1 if mid position and a score of 2 if anterior. So, a total score (sum of all scores) of zero at a minimum to 10 at a maximum can be estimated.~Note that a score more than 10 means patient is in labor not needing induction of labor."|72 hours||||units on a scale||Inter-Quartile Range|Median
2558409|NCT02694315|Primary|Cervical Length Prior to Labor Induction|median cervical length measured by transvaginal ultrasound in centimetres|24 hours||||centimetres||Inter-Quartile Range|Median
2558410|NCT02694198|Primary|Relation of Cervicovaginal Fetal Fibronectin Level to Duration of Induction of Abortion|Difference between women who expulsed the fetus within 24 hours and women who expulsed the fetus in more than 24 hours as regarding cervicovaginal fetal fibronectin level (ng/ml)|72 hours||||nanogram per milliliter||Standard Deviation|Mean
2558411|NCT02694198|Primary|Cervicovaginal Fetal Fibronectin Level|mean cervicovaginal fetal fibronectin level in women undergoing midtrimesteric induction of abortion|72 hours|Depending on Francesco et al., 2005 who found that Fetal fibronectin test positive in 19 among 270 (7.0%) women undergoing mid-trimester abortion. Assuming α=0.05 and confidence interval (CI)= 10.0% and by using PASS 11th release the minimal sample size is 120. With a possible 10% drop out of cases, the enrolled cases would be 135 cases.|||nanogram per milliliter||Standard Deviation|Mean
2558412|NCT02693834|Secondary|Gait Velocity SSV and FPV|using GAITRite for Self selected velocity (SSV)walk and fast paced velocity (FPV) walk|at baseline,1 week with DA AFO, 1 week with PLS AFO||||meter per sec||Standard Deviation|Mean
2558418|NCT02693704|Primary|Speaker's Localization|"Localization error (in number of spatial sectors)~For each group: average localization error over all subjects in the group. It is the difference between the actual spatial sector and the one reported by the listeners. There were 5 spatial sectors, and 9 possible locations. For instance: if the stimuli is played in sector 4, and the listener perceives it in 2, then the localization error is |4-2| = 2. The goal is to compare the localization error in 3 conditions: 1/ with no hearing aids (reference of natural localization) and no spatialization 2/ with hearing aids and standard fittings and no spatialization, and 3/ with spatialization applied."|1 day of the experiment||||Localization error (# spatial sectors)||Standard Deviation|Mean
2558419|NCT02693704|Primary|Speech Intelligibility|Speech recognition score (%) For each group: average of the SRS over all subjects in the group. The SRS correspond to the number of understood words in a sequence of sentences (French HINT database) mixed with several level of masking noise (speech-shaped noise). Some are played diotically, the other are spatialized in various directions. The goal is to ensure that the spatialization processing does not degrade the understanding of the speech.|1 day of the experiment||||Percentage of understood word||Standard Deviation|Mean
2558420|NCT02693171|Secondary|To Determine the Effect of HACA on Dinutuximab Plasma Concentrations.|"Ten blood samples were collected at the following time points for the evaluation of dinutuximab plasma concentrations:~Course 1— Prior to the first Unituxin infusion~Course 2— Prior to the first Unituxin infusion~Course 3— Prior to the first Unituxin infusion~Course 4— Prior to the first Unituxin infusion~Course 5— Prior to the first Unituxin infusion~Course 6— Prior to the first dose of 13-cis-retinoic acid (RA)~Study termination (approximately 2 weeks following the final 13-cis-retinoic acid dose).~An additional 3 blood samples were obtained for the evaluation of dinutuximab plasma concentrations. Each of these blood samples was obtained immediately following the fourth dinutuximab infusion in Courses 1, 3, and 5."|Approximately 6 months|Outcome measure data were not collected. Sponsor was required to run this Phase 4 study for EU marketing approval. However, Sponsor terminated the study 15 Dec 2016 and application withdrawn (accepted by European Commission 20 Mar 2017).||||||
2558421|NCT02693171|Secondary|To Determine the Incidence of Neutralizing Antibody (NAb) in Patients With Human Anti-chimeric Antibody (HACA) Positive Samples.|Incidence of neutralizing antibody (NAb) in patients with human anti-chimeric antibody (HACA) positive samples was summarized and listed.|Approximately 6 months|Outcome measure data were not collected. Sponsor was required to run this Phase 4 study for EU marketing approval. However, Sponsor terminated the study 15 Dec 2016 and application withdrawn (accepted by European Commission 20 Mar 2017).||||||
2558422|NCT02693171|Secondary|To Determine the Incidence of Targeted Immune-related Adverse Events (AEs) During Treatment With Dinutuximab Combination Therapy in High-risk Neuroblastoma Subjects.|The incidence of targeted immune-related adverse events (AEs) during treatment with dinutuximab combination therapy in high-risk neuroblastoma subjects were summarized and listed.|Approximately 6 months|Outcome measure data were not collected. Safety data from the 12 subjects dosed prior to study termination were collected and summary level data were reported (eg, total number of subjects affected and total number of events for dinutuximab-treated subjects). Please refer to the adverse event tables for results.||||||
2558423|NCT02693171|Primary|To Determine the Incidence of Human Anti-chimeric Antibody (HACA) in High-risk Neuroblastoma Patients Treated With Unituxin Combination Therapy.|"Seven blood samples were collected at the following time points for the evaluation of HACA levels:~Course 1— Prior to the first Unituxin infusion~Course 2— Prior to the first Unituxin infusion~Course 3— Prior to the first Unituxin infusion~Course 4— Prior to the first Unituxin infusion~Course 5— Prior to the first Unituxin infusion~Course 6— Prior to the first dose of 13-cis-retinoic acid (RA)~Study termination (approximately 2 weeks following the final 13-cis-retinoic acid dose)"|Approximately 6 months|Outcome measure data were not collected. Sponsor was required to run this Phase 4 study for EU marketing approval. However, Sponsor terminated the study 15 Dec 2016 and application withdrawn (accepted by European Commission 20 Mar 2017).||||||
2558424|NCT02693132|Secondary|Change in Energy Intake|Measured as kcal/day using a questionnaire|Baseline (0 weeks),12 Weeks||||kcal/day||Standard Deviation|Mean
2558425|NCT02693132|Secondary|Change in Fat Mass|Measured as fat mass (kg) using dual-energy x-ray absorptiometry (DXA)|Baseline (0 weeks),12 Weeks||||kilograms||Standard Deviation|Mean
2558426|NCT02693132|Secondary|Change in Body Weight|Measured in kilograms using a digital scale|Baseline (0 weeks),12 Weeks||||kilograms||Standard Deviation|Mean
2558427|NCT02693132|Secondary|Change in Cardiorespiratory Fitness|Measured using a submaximal graded exercise test on a treadmill, with termination occurring at 85% of age-predicted maximal heart rate (computed at [220-age]*0.85]). The outcome was measures as oxygen consumption (ml/kg/min) at the point of test termination.|Baseline (0 weeks),12 Weeks||||ml/kg/min||Standard Deviation|Mean
2558428|NCT02693132|Primary|Change in Moderate-to-Vigorous Physical Activity (Accumulated in Bouts of at Least 10 Minutes)|Measured using a wearable device and by questionnaire|Baseline (0 weeks), 4 Weeks, 8 Weeks, 12 Weeks||||minutes/day||Standard Deviation|Mean
2558429|NCT02693106|Primary|Concentration of Total Plasma Ketones|"Difference from Time 0 in Total ketones = acetoacetate (umol/L) + beta-hydroxybutyrate (umol/L) Time 0 is when the participants arrived, after a 12 hours fast, i.e. before the breakfast.~Plasma was collected every 30 minutes for 4 hours immediately following breakfast (where supplements were taken).~Results are the mean of plasma ketones measured every 30 minutes ( i.e. total of 9 plasma samples) for the 4 hour period.~For each time point, the difference form time 0 has been made. So this is the mean of the difference from time 0 in total ketones.~Data were not collected for the 'Intervention 8: 65 g of butter fraction rich in MCT' supplement."|4 hours||||µmol/L||Standard Error|Mean
2558430|NCT02693002|Secondary|B-type Natriuretic Peptide (BNP) Levels|Change in B-type natriuretic peptide (BNP) levels will be measure. Participants will have blood drawn via venipuncture and B-type natriuretic peptide will be measured using a quantitative chemiluminescent immunoassay. Data will be presented as the change in B-type natriuretic peptide over time.|Baseline and 12 weeks|Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality.||||||
2558532|NCT02691572|Secondary|Level of Sedation|Assessed using a 4-point scale (1 = awake and alert, 2 = minimally sedated, responds to speech, 3 = moderately sedated, rousable by tactile stimulation, 4 = deeply sedated, rousable only with painful stimulation).|24 h|||||||
2558431|NCT02693002|Secondary|Quality of Life Score Assessed by Utian Quality of Life Scale (UQoLS)|"Change in quality of life score as assessed by Utian Quality of Life scale. The UQoLS measures quality of life in four subcategories: Occupational, health, emotional and sexual. Questions are scored on a scale of 1-5 were 1 indicates Not true of me and 5 indicates an answer of mostly true. Scores to the responses are added and evaluated within each subcategory. Higher scores indicate a higher quality of life within each subcategory with a maximum of 35 points for Occupational, 31 points for Health, 28 points for Emotional and 15 points for Sexual for a total of 100 points indicating the highest quality of life score possible. Data will be presented as the change in quality of life Mean +/- SEM over time."|Baseline and 12 weeks|Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality.||||||
2558432|NCT02693002|Secondary|Activity Level Assessed by Duke Activity Status Index (DASI)|"Change in activity level as assessed by Duke Activity Status Index. The DASI estimates functional capacity through a series of 12 questions related to daily activity. Questions are scored as zero for a No answer or awarded a fixed number of points ranging from 1.75-8 for a Yes answer. Scores for each question are added, with the maximum score being 58.2 indicating a fully functional individual. Data are presented as the change in Mean score +/- SEM for each group at baseline and 12 weeks."|Baseline and 12 weeks|Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality.||||||
2558433|NCT02693002|Primary|Diastolic Function Assessed by Echocardiography|Change in diastolic function as assessed by echocardiography from baseline to 12 weeks|Baseline and 12 weeks|Data was not analyzed for this study. The study was terminated as a result of poor enrollment (N=1, Hormone replacement 1; N=2, placebo). Presenting data for such a low number of participants would compromise participant confidentiality.||||||
2558434|NCT02692859|Secondary|the Anti-PRP Geometric Mean Fold Increase (GMFI)||28 days after full course of vaccination|||||||
2558435|NCT02692859|Secondary|the Anti-PRP Geometric Mean Concentrations (GMCs)||28 days after full course of vaccination|||||||
2558436|NCT02692859|Secondary|Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥0.15μg/ml||28 days after full course of vaccination|||||||
2558437|NCT02692859|Secondary|Incidence of Serious Adverse Event (SAE) During the Whole Study Period||0-84 days for children aged 3-5 months, 0-56 days for children aged 6-11 months and 0-28 days for children aged 1-5 y|||||||
2558438|NCT02692859|Secondary|Incidence of Unsolicited Adverse Reactions||0-28 days after each dose|||||||
2558439|NCT02692859|Primary|Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥1.0μg/ml||28 days after full course of vaccination||2017-12-31|12/2017||||
2558440|NCT02692859|Primary|Number of Participants With Solicited Adverse Reactions|Number of Participants with Solicited Adverse Reactions|0-7 days after each dose|A total of participants in aged 3-5 months,6-11months and 1-5years|||Count of Participants|||Number
2558441|NCT02692716|Secondary|Change in Triglycerides - Ratio to Baseline|Change from baseline (week 0) in triglycerides (mmol/L) at end of treatment visit (week 83) is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.|Week 0, End of treatment|Overall number of participants analyzed = number of participants with available data.|||Ratio of triglycerides||Geometric Coefficient of Variation|Geometric Mean
2558442|NCT02692716|Secondary|Change in HDL-cholesterol - Ratio to Baseline|Change from baseline (week 0) in HDL cholesterol (mmol/L) at end of treatment visit (week 83) is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.|Week 0, End of treatment|Overall number of participants analyzed = number of participants with available data.|||Ratio of HDL-cholesterol||Geometric Coefficient of Variation|Geometric Mean
2558443|NCT02692716|Secondary|Change in LDL-cholesterol - Ratio to Baseline|Change from baseline (week 0) in LDL cholesterol (mmol/L) at end of treatment visit (week 83) is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.|Week 0, End of treatment|Overall number of participants analyzed = number of participants with available data.|||Ratio of LDL-cholesterol||Geometric Coefficient of Variation|Geometric Mean
2558444|NCT02692716|Secondary|Change in Total Cholesterol - Ratio to Baseline|Change from baseline (week 0) in total cholesterol (mmol/L) at the end of treatment (week 83) visit is presented as ratio to baseline. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.|Week 0, End of treatment|Overall number of participants analyzed = number of participants with available data.|||Ratio of total cholesterol||Geometric Coefficient of Variation|Geometric Mean
2558445|NCT02692716|Secondary|Change in Body Weight|Change from baseline (week 0) in body weight measured at the end of treatment visit (week 83) is reported. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.|Week 0, End of treatment|Overall number of participants analyzed = number of participants with available data.|||Kg||Standard Deviation|Mean
2558446|NCT02692716|Secondary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline (week 0) in HbA1c measured at the end of treatment visit (week 83) is reported. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.|Week 0, End of treatment|Overall number of participants analyzed = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2558533|NCT02691572|Secondary|Number of Patients With Nausea and/or Vomiting|The occurrence of nausea and/or vomiting will be observed and recorded.|24 h|||||||
2558447|NCT02692716|Secondary|Change in Systolic and Diastolic Blood Pressure|Change from baseline (week 0) in systolic and diastolic blood pressure measured at the end of treatment visit (week 83) is reported. Results are based on the on-treatment observation period which started at the date of first dose on trial product, ended on last date on trial product +38 days (ascertainment window).|Week 0, End of treatment|Overall number of participants analyzed = number of participants with available data.|||mmHg||Standard Deviation|Mean
2558448|NCT02692716|Secondary|Change in Pulse Rate|Change from baseline (week 0) in pulse rate measured at the end of treatment visit (week 83) is reported. Results are based on the on-treatment observation period which started at the date of first dose on trial product, ended on last date on trial product +38 days (ascertainment window).|Week 0, End of treatment|Overall number of participants analyzed = number of participants with available data.|||Beats/minute||Standard Deviation|Mean
2558449|NCT02692716|Secondary|Change in Eye Examination Category|Participants with eye examination findings, normal, abnormal non clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -3) and end of treatment visit (week 83) are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.|Week -3, End of treatment|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2558450|NCT02692716|Secondary|Number of Serious Adverse Events|Number of serious adverse events were recorded from week 0 to week 87 in the study. Results are based on the on-treatment observation period which started at the date of first dose on trial product and ended on last date on trial product +38 days (ascertainment window).|Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window.|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Events|||Number
2558451|NCT02692716|Secondary|Time to First AE Leading to Permanent Trial Product Discontinuation|Number of participants who permanently discontinued trial product in ths study are presented. Results are based on the on-treatment observation period which starts at the date of first dose on trial product; ends on last date on trial product +38 days (ascertainment window).|Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 38 days of ascertainment window.|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2558452|NCT02692716|Secondary|Time From Randomisation to All-cause Death|Number of all-cause deaths in the study are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.|Maximum treatment duration is dependent on event rates and is expected to be no longer than 19 months + 5 weeks of follow-up period.|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2558453|NCT02692716|Secondary|Time From Randomisation to First Occurrence of Fatal or Non-fatal Stroke|Number of participants experiencing a first event of a fatal or non-fatal stroke are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.|Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2558454|NCT02692716|Secondary|Time From Randomisation to First Occurrence of Fatal or Non-fatal Myocardial Infarction|Number of participants experiencing a first event of a fatal or non-fatal myocardial infarction are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.|Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2558455|NCT02692716|Secondary|Time From Randomisation to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, Non-fatal Myocardial Infarction or Nonfatal Stroke|Participants experiencing first occurrence of a composite CV endpoint (defined as all-cause death, non-fatal myocardial infarction or nonfatal stroke) are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.|Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2558456|NCT02692716|Secondary|Time From Randomisation to First Occurrence of Each of the Individual Components in the Expanded Composite Cardiovascular Endpoint|Participants experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospitalisation or heart failure requiring hospitalisation) are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.|Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2558472|NCT02692495|Secondary|Discriminative Biomarkers in the Subgroups of Malodor|"The investigators have comprehensively analyzed diagnostic ability of tests taken by participants to correlate with their symptoms using several statistical techniques known to bring out strong patterns in a dataset. Principal component analysis (PCA) allowed to clearly separate data into two clusters (Sour and Sweet) shown below along with the Lactic subgroup from the Sour group."|three years||||umol/L||Standard Deviation|Mean
2558457|NCT02692716|Secondary|Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, UAP Requiring Hospitalisation or Hospitalisation for Heart Failure|Participants experiencing first occurrence of an expanded composite CV endpoint [defined as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, UAP (unstable angina pectoris) requiring hospitalisation or heart failure requiring hospitalisation] are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.|Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2558458|NCT02692716|Primary|Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE) Composite Endpoint Consisting of: Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke|Number of participants experiencing a first event of a MACE, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke are presented. Results are based on the in-trial observation period which started at the date of randomisation, included the period after permanent trial product discontinuation, if any and ended at the date of the follow-up visit regardless of adherence to treatment.|Maximum treatment duration is dependent on event rates and is estimated to be no longer than 19 months + 5 weeks of follow-up period.|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants.|||Participants|||Count of Participants
2558459|NCT02692703|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug (up to 12 weeks)|All participants who received at least 1 dose of study drug, completed treatment, had HCV RNA <LLOQ at the final treatment visit, and had post-treatment data available, excluding reinfection.|||percentage of participants|||Number
2558460|NCT02692703|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Up to 12 weeks|ITT population|||percentage of participants|||Number
2558461|NCT02692703|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 compared with the historical SVR12 rate for the current standard of care regimens (sofosbuvir [SOF]/ledipasvir [LDV] + ribavirin [RBV] OR SOF + daclatasvir [DCV] + RBV). Participants with missing data after backward imputation were counted as non-responders.|12 weeks after the last dose of study drug (up to 24 weeks)|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2558462|NCT02692560|Secondary|Depressive Symptoms|Change in Patient Health Questionnaire (PHQ-8) scale score, from baseline to 12 weeks. The scale range is 0 to 24 with higher scores representing higher depressive symptoms. Scores of 10 or more are considered major depression.|12 weeks|6 Healthy Living participants withdrew before completing the study|||units on a scale||Standard Deviation|Mean
2558463|NCT02692560|Secondary|Total Cholesterol (mg/dL)|Change in total cholesterol (mg/dL) from finger stick blood draw, from baseline to 12 weeks|12 weeks|6 Healthy Living participants withdrew before completing the study|||mg/dL||Standard Deviation|Mean
2558464|NCT02692560|Secondary|Fasting Glucose (mg/dL)|Change in fasting glucose (mg/dL) from finger stick blood draw, from baseline to 12 weeks|12 weeks|6 Healthy Living participants withdrew before completing the study|||mg/dL||Standard Deviation|Mean
2558465|NCT02692560|Secondary|Blood Pressure (Systolic Blood Pressure)|Change in average of second and third blood pressure reading (for systolic blood pressure), from baseline to 12 weeks|12 weeks|6 Healthy Living participants withdrew before completing the study|||mmHg||Standard Deviation|Mean
2558466|NCT02692560|Secondary|Physical Function|Change in Short Physical Performance Battery (SPPB) scale score, from baseline to 12 weeks. The range of scores is 0 to 12, higher values represent better physical function.|12 weeks|6 Healthy Living participants withdrew before completing the study|||units on a scale||Standard Deviation|Mean
2558467|NCT02692560|Secondary|Periods of Sitting for 30+ Minutes|Change in average daily number of activPAL-measured periods of sitting for 30+ minutes without standing, from baseline to 12 weeks|12 weeks|6 Healthy Living participants withdrew before completing the study|||bouts||Standard Deviation|Mean
2558468|NCT02692560|Secondary|Sit-to-stand Transitions|Change in average daily number of activPAL-measured sit-to-stand transitions, from baseline to 12 weeks|12 weeks|6 Healthy Living participants withdrew before completing the study|||transitions||Standard Deviation|Mean
2558469|NCT02692560|Primary|Change in Hours of Sitting Time|Average hours of sitting time over the last 7 days measured at baseline and 12 weeks later|12 weeks|6 Healthy Living participants withdrew before completing the study|||minutes||Standard Deviation|Mean
2558470|NCT02692495|Secondary|Average Daily Added Sugar Intake Inferred From Self-reported Dietary Data in the Subgroups of Malodor|The measurement of dietary intake of selected nutrients from self-reported food intakes and diet history questionnaires. Correlation of symptoms with added sugar in the diet were noted independently on the source of malodor.|Three years||||grams per day||Standard Deviation|Mean
2558471|NCT02692495|Secondary|Number of Test Results Outside the Normal Range in Different Subgroups of Malodor|Disciminative biomarkers for groups of malodor discovered using PCA, compared to control group|Three years||||Participants|||Count of Participants
2558473|NCT02692495|Primary|Number of Test Results Outside the Normal Range|The investigators would like to evaluate the strength of evidence in diagnostic accuracy of laboratory tests taken by participants (listed in the detailed description of the study), for diagnosing malodor syndromes. Values measured by the laboratory (Biolab Medical Unit) will be compared against the reference range specific to that laboratory.|four years||||participants|||Number
2558475|NCT02692482|Secondary|Pressure Ulcer Rate in the Sacral Area of Grade ≥ II According to the National Pressure Ulcers Advisory Panel Classification|Pressure ulcer are classified and described through the use of staging systems. Staging systems describe the extent of tissue loss and the physical appearance of the injury caused by pressure and/or shear. From stage 1 (intact skin) to Stage 4 (Full-thickness skin and tissue loss).|On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.||||Participants|||Count of Participants
2558476|NCT02692482|Secondary|Number of Participants With Pressure Ulcers in Other Areas (Heel, Back and Calf)||On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.||||Participants|||Count of Participants
2558477|NCT02692482|Primary|Number of Participants With Pressure Sores||On the eighth day of hospitalization or upon discharge from hospital, if that occurs before the eighth day.||||Participants|||Count of Participants
2558478|NCT02692417|Primary|18 Weeks - Total FSFI Score|Sexual function was measured by the Female Sexual Function Index (FSFI), which is a validated, 19-item questionnaire evaluating sexual functioning in women. A clinical cutoff score of 26.55 differentiates women with and without sexual dysfunction, with below a 26.55 indicating sexual dysfunction. The minimum score one can receive is 2, and the maximum score is 36. Higher scores indicate better sexual functioning. The total FSFI score is the sum of the six subcategories (desire, arousal, lubrication, orgasm, satisfaction and pain) which each have a maximum score of 6. Each subcategory has questions scored either 0-5 (arousal, lubrication, orgasm, pain) or 1-5 (desire, satisfaction). The sum for each subcategory is multiplied by a factor of either 0.3 (arousal, lubrication), 0.4 (orgasm, satisfaction, pain) or 0.6 (desire). The minimum score for desire is 1.2 and for satisfaction is 0.8, the rest are 0. Only the results from the 9 subjects who completed the study were analyzed.|18 weeks after start of treatment||||score on a scale||Standard Deviation|Mean
2558479|NCT02692417|Primary|12 Weeks - Total FSFI Score|Sexual function was measured by the Female Sexual Function Index (FSFI), which is a validated, 19-item questionnaire evaluating sexual functioning in women. A clinical cutoff score of 26.55 differentiates women with and without sexual dysfunction, with below a 26.55 indicating sexual dysfunction. The minimum score one can receive is 2, and the maximum score is 36. Higher scores indicate better sexual functioning. The total FSFI score is the sum of the six subcategories (desire, arousal, lubrication, orgasm, satisfaction and pain) which each have a maximum score of 6. Each subcategory has questions scored either 0-5 (arousal, lubrication, orgasm, pain) or 1-5 (desire, satisfaction). The sum for each subcategory is multiplied by a factor of either 0.3 (arousal, lubrication), 0.4 (orgasm, satisfaction, pain) or 0.6 (desire). The minimum score for desire is 1.2 and for satisfaction is 0.8, the rest are 0. Only the results from the 9 subjects who completed the study were analyzed.|12 weeks after beginning of treatment||||score on a scale||Standard Deviation|Mean
2558480|NCT02692417|Primary|6 Weeks - Total FSFI Score|Sexual function was measured by the Female Sexual Function Index (FSFI), which is a validated, 19-item questionnaire evaluating sexual functioning in women. A clinical cutoff score of 26.55 differentiates women with and without sexual dysfunction, with below a 26.55 indicating sexual dysfunction. The minimum score one can receive is 2, and the maximum score is 36. Higher scores indicate better sexual functioning. The total FSFI score is the sum of the six subcategories (desire, arousal, lubrication, orgasm, satisfaction and pain) which each have a maximum score of 6. Each subcategory has questions scored either 0-5 (arousal, lubrication, orgasm, pain) or 1-5 (desire, satisfaction). The sum for each subcategory is multiplied by a factor of either 0.3 (arousal, lubrication), 0.4 (orgasm, satisfaction, pain) or 0.6 (desire). The minimum score for desire is 1.2 and for satisfaction is 0.8, the rest are 0. Only the results from the 9 subjects who completed the study were analyzed.|6 weeks after beginning of treatment||||score on a scale||Standard Deviation|Mean
2558481|NCT02692235|Secondary|Lipid Metabolites|Change in serum lipid metabolites: total cholesterol (TCh), HDL-cholesterol (HDL), LDL-cholesterol (LDL), triglycerides (TG) determined by standard automatic analyzer Cobas 6000 (Roche Diagnostics, Mannheim, Germany)|baseline and after 24 weeks of supplementation period|1 male and 1 smoking female subjects excluded from the *Placebo* statistical analyses for group homogeneity|||mg·dL^-1||Standard Deviation|Mean
2558482|NCT02692235|Primary|Blood Inflammatory Marker|Serum C-reactive protein concentration determined by the enzyme immunoassay method using commercially available kit (Cloud-Clone Corp., Houston, USA)|baseline and after 24 weeks of supplementation period|1 male and 1 smoking female subjects excluded from the *Placebo* statistical analyses for group homogeneity|||mg·L^-1||Standard Deviation|Mean
2558483|NCT02691936|Secondary|Rate of Satisfaction of Patients With Treatment|Patient global impression of improvement (PGI) is a 5-point Likert scale evaluating patient satisfaction after treatment. The 5-point Likert scale for satisfaction indicates 1(Very dissatisfied), 2(Dissatisfied), 3(Same), 4(Satisfied) or 5(Very satisfied). As reported, the responses for level of dissatisfaction after treatment on the Patient Global Index included responses of very dissatisfied and dissatisfied. This is directly out of the questionnaire given to the patient to complete.|6 months||||Participants|||Count of Participants
2558484|NCT02691936|Secondary|Effect of Treatment on Urinary Symptoms|Urogenital distress inventory (UDI-6) is measures on a scale of 0 (minimum) to 75 (maximum) with higher scores representing less favorable outcomes (more severe urinary symptoms). Data here are presented as mean differences from before and after treatment.|6 months||||units on a scale||Full Range|Mean
2558485|NCT02691936|Secondary|Effect of Treatment on Female Sexual Function|Female Sexual Function Index (FSFI) scores are on a scale of 0 (minimum) to 36 (maximum) with higher scores representing more favorable outcomes. The scores represent the difference between baseline and 6 month follow up. A negative difference signifies worsened function whereas a positive difference signifies improvement.|6 months||||units on a scale||Full Range|Mean
2558486|NCT02691936|Secondary|Vaginal Wall Elasticity Assessed by Number of Participants Able to Tolerate a Larger Vaginal Dilator Size|"Participants who were able to tolerate a larger dilator size compared to before treatment (representing improvement in vaginal wall elasticity) were marked as yes and participants who could not tolerate a larger size (representing no change in vaginal elasticity) were marked as no."|6 months|The data above are represented in tabular form.|||Participants|||Count of Participants
2558534|NCT02691572|Secondary|Pain Scores at Rest and Movement|Assessed using 11-point verbal rating scale (0 = no pain, 10 = the worst possible pain), at rest and movement.|2, 4, 6, 12, and 24 h|||||||
2558535|NCT02691572|Secondary|Time to the First Postoperative Fentanyl Administration||24 h|||||||
2558487|NCT02691936|Secondary|Effect of Treatment on Vaginal Maturation Index|Vaginal Maturity Index (VMI) scores are from 0 (minimum) to 100 (maximum) with higher scores representing higher maturity which is a favorable (better) outcome. The results reported are the difference between 2 time points (baseline and 6 month follow up). A change in outcome which is negative signifies a worse outcome. Conversely, a positive change signifies improvement.|6 months||||units on a scale||Full Range|Mean
2558488|NCT02691936|Secondary|Effect of GMS Symptoms on Quality of Life|DIVA scores are based on a scale of 0 (minimum) to 20 (maximum) with higher scores representing worse outcomes. The data presented are mean differences before and after treatment.|6 months||||units on a scale||Full Range|Mean
2558489|NCT02691936|Secondary|Objective Evaluation of Vaginal Atrophy/Estrogenization|Vaginal health index (VHI) score is measured on a scale of 0 (minimum) to 5 (maximum) and higher scores means a better outcome.|6 months||||units on a scale||Full Range|Mean
2558490|NCT02691936|Primary|Vaginal Dryness|Vaginal dryness was assessed using a score of 0 (minimum) and 10 (maximum) on a Visual Analog Scale (VAS). Data presented is the mean difference before and after treatment. A higher mean difference signifies that the vaginal dryness score decreased to a greater measure hence resulting in a better outcome.|6 months||||units on a scale||Full Range|Mean
2558491|NCT02691741|Secondary|Subject Satisfaction Recorded at Day 120-180|"At the Month 6 Visit, subjects responded to the question: Given your current postoperative vision, if you had to do it all over would you have the same lens implanted again?. Responses were reported as a percentage of subjects. No statistical test was performed."|Day 120-180 from second eye implantation|All-Implanted Analysis Set with data available|||percentage of subjects|||Number
2558492|NCT02691741|Secondary|Mean Mesopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180|Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.|Day 120-180 from second eye implantation|Best-Case Analysis Set, with data available|||log units||Standard Deviation|Mean
2558493|NCT02691741|Secondary|Mean Mesopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180|Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in dim to dark conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, and 12 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.|Day 120-180 from second eye implantation|Best-Case Analysis Set with data available|||log units||Standard Deviation|Mean
2558494|NCT02691741|Secondary|Mean Photopic With Glare Binocular Distance Contrast Sensitivity at Day 120-180|Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 CPDs and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.|Day 120-180 from second eye implantation|Best-Case Analysis Set, with data available|||log units||Standard Deviation|Mean
2558495|NCT02691741|Secondary|Mean Photopic Without Glare Binocular Distance Contrast Sensitivity at Day 120-180|Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly in lighted conditions with distance manifest correction in place and uncorrected, with no glare source illumination. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (CPD) and reported in log units. A higher numeric value represents better contrast sensitivity. No statistical test was performed.|Day 120-180 from second eye implantation|Best-Case Analysis Set, with available data|||log units||Standard Deviation|Mean
2558496|NCT02691741|Secondary|Mean Photopic Binocular Defocus Curve at Day 120-180|A defocus curve is created by multiple measurements of one's visual acuity (VA) at different spherical powers. VA was measured in logMAR. A lower logMAR value indicates better visual acuity. No statistical test was performed.|Day 120-180 from second eye implantation|This analysis population includes all subjects with eyes successfully implanted with the test or control article that had at least one postoperative visit, and with no macular degeneration at any time, and no major protocol deviations (Best-Case Analysis Set), with data available.|||logMAR||Standard Deviation|Mean
2558497|NCT02691741|Secondary|Least Squares Mean Binocular Uncorrected Near VA (40cm) at Day 120-180|VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 40 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.|Day 120-180 from second eye implantation|All-Implanted Analysis Set|||logMAR||Standard Error|Least Squares Mean
2558498|NCT02691741|Secondary|Least Squares Mean Binocular Uncorrected Distance VA (4m) at Day 120-180|VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.|Day 120-180 from second eye implantation|All-Implanted Analysis Set|||logMAR||Standard Error|Least Squares Mean
2558499|NCT02691741|Secondary|Least Squares Mean Binocular UCIVA (60cm) at Day 120-180|VA was tested binocularly with no refractive correction in place using an ETDRS chart set at 60 cm. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity.|Day 120-180 from second eye implantation|All-Implanted Analysis Set|||logMAR||Standard Error|Least Squares Mean
2558500|NCT02691741|Primary|Least Squares Mean Binocular Uncorrected Intermediate Visual Acuity (UCIVA) (60cm) at Day 120-180|"VA was tested binocularly (both eyes together) with no refractive correction in place using an early treatment diabetic retinopathy study (ETDRS) chart set at 60 cm. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity."|Day 120-180 from second eye implantation|All-Implanted Analysis Set|||logMAR||Standard Error|Least Squares Mean
2558536|NCT02691572|Secondary|Cumulative Fentanyl Dose||2, 4, 6, 12 h|||||||
2558501|NCT02691702|Secondary|Change From Baseline for Dim Light Melatonin Onset (DLMO) Time - Day 15|DLMO was defined as point in time when the smooth melatonin curve exceeds the threshold. The threshold for each melatonin profile was calculated as the mean of three low consecutive daytime values (raw data points) plus twice the standard deviation of these points.|Day 0 (Baseline) and Day 15|The PD population was defined as all enrolled participants treated who provided at least 3 measurable salivary melatonin concentrations.|||min||Standard Deviation|Mean
2558502|NCT02691702|Secondary|Change From Baseline for Dim Light Melatonin Onset (DLMO) Time - Day 6|Dim Light Melatonin Onset (DLMO) was defined as point in time when the smooth melatonin curve exceeds the threshold. The threshold for each melatonin profile was calculated as the mean of three low consecutive daytime values (raw data points) plus twice the standard deviation of these points.|Day 0 (Baseline) and Day 6.|The PD (pharmacodynamic) population was defined as all enrolled participants treated who provided at least 3 measurable salivary melatonin concentrations.|||min||Standard Deviation|Mean
2558503|NCT02691702|Secondary|Renal Clearance (CLr) of PF-05251749 - Day 14|Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), Aetau/AUCtau.|Day 14 (0, 0.5, 1, 1.5, 2, 3, 4, 5, 8, 12, 16, 20, 24, 48h).|The PK parameter population was defined as all enrolled participants treated who received at least 1 dose of PF-05251749 and had at least 1 of the PK parameters of interest measured.|||mL/hr||Geometric Coefficient of Variation|Geometric Mean
2558504|NCT02691702|Secondary|Percentage of Dose Recovered Unchanged in Urine Over Dosing Interval Tau (Aetau%) of PF-05251749 - Day 14|Aetau% was the percentage of dose recovered unchanged into urine from 0 to end of the dosing interval, which was calculated by 100 × Aetau/Dose.|Day 14 (0, 0.5, 1, 1.5, 2, 3, 4, 5, 8, 12, 16, 20, 24, 48h).|The PK parameter population was defined as all enrolled participants treated who received at least 1 dose of PF-05251749 and had at least 1 of the PK parameters of interest measured.|||Percentage of PF-05251749||Geometric Coefficient of Variation|Geometric Mean
2558505|NCT02691702|Secondary|Cumulative Amount of Drug Recovered Unchanged in Urine Over Dosing Interval Tau (Aetau) of PF-05251749 - Day 14|Aetau was the cumulative amount of drug recovered unchanged in urine from time 0 to end of the dosing interval, which was calculated by sum of (urine concentration × volume of urine).|Day 14 (0, 0.5, 1, 1.5, 2, 3, 4, 5, 8, 12, 16, 20, 24, 48h).|The PK parameter population was defined as all enrolled participants treated who received at least 1 dose of PF-05251749 and had at least 1 of the PK parameters of interest measured.|||ng||Geometric Coefficient of Variation|Geometric Mean
2558506|NCT02691702|Secondary|Apparent Volume of Distribution (Vz/F) of PF-05251749 - Day 14|Apparent volume of distribution (Vz/F) was calculated by Dose/(AUCtau × kel) on Day 14.|Day 14 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 48h).|The PK parameter population was defined as all enrolled participants treated who received at least 1 dose of PF-05251749 and had at least 1 of the PK parameters of interest measured.|||L||Geometric Coefficient of Variation|Geometric Mean
2558507|NCT02691702|Secondary|Terminal Half-Life (t1/2) of PF-05251749 - Day 14|Terminal half-life (t1/2) was calculated as Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.|Day 14 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 48h).|The PK parameter population was defined as all enrolled participants treated who received at least 1 dose of PF-05251749 and had at least 1 of the PK parameters of interest measured.|||hr||Standard Deviation|Mean
2558508|NCT02691702|Secondary|Observed Accumulation Ratio for Cmax (Rac,Cmax) of PF-05251749 - Days 7 and 14|Observed accumulation ratio for Cmax (Rac,Cmax) was calculated as: Cmax on Day 7 or 14 divided by Cmax on Day 1.|Days 7 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24h) and 14 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 48h).|The PK parameter population was defined as all enrolled participants treated who received at least 1 dose of PF-05251749 and had at least 1 of the PK parameters of interest measured.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2558509|NCT02691702|Secondary|Observed Accumulation Ratio (Rac) of PF-05251749 -Days 7 and 14|Observed accumulation ratio (Rac) was calculated as AUCtau (Days 7 or 14) divided by AUCtau (Day 1).|Days 7 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24h) and 14 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 48h).|The PK parameter population was defined as all enrolled participants treated who received at least 1 dose of PF-05251749 and had at least 1 of the PK parameters of interest measured.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2558510|NCT02691702|Secondary|Plasma Peak-to-trough Ratio (PTR) (Cmax/Cmin) of PF-05251749 - Days 7 and 14|Peak-to-through ratio (PTR) was the ratio of Cmax to Cmin, which was measured on Days 7 and 14.|Days 7 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24h) and 14 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 48h).|The PK parameter population was defined as all enrolled participants treated who received at least 1 dose of PF-05251749 and had at least 1 of the PK parameters of interest measured.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2558511|NCT02691702|Secondary|Minimum Concentration Observed (Cmin) of PF-05251749 - Days 7 and 14|Minimum concentration observed (Cmin) of PF-05251749 was observed directly from data on Days 7 and 14.|Days 7 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24h) and 14 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 48h).|The PK parameter population was defined as all enrolled participants treated who received at least 1 dose of PF-05251749 and had at least 1 of the PK parameters of interest measured.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2558512|NCT02691702|Secondary|Apparent Clearance (CL/F) of PF-05251749 - Days 7 and 14|Apparent clearance was influenced by the fraction of the dose absorbed, which was measured by Dose/AUCtau.|Days 7 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24h) and 14 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 48h).|The PK parameter population was defined as all enrolled participants treated who received at least 1 dose of PF-05251749 and had at least 1 of the PK parameters of interest measured.|||Liter/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2558513|NCT02691702|Secondary|Time at Which Cmax Occurred (Tmax) of PF-05251749 - Days 1, 7 and 14|Tmax of PF-05251749 was observed directly from data on Days 1, 7 and 14, as time of first occurrence.|Days 1 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 48h), 7 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24h) and 14 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 48h).|The PK parameter population was defined as all enrolled participants treated who received at least 1 dose of PF-05251749 and had at least 1 of the PK parameters of interest measured.|||hr||Full Range|Median
2558537|NCT02691572|Primary|Cumulative Fentanyl Dose||24 h||||mcg||Standard Deviation|Mean
2558514|NCT02691702|Secondary|Area Under the Concentration-Time Profile From Time 0 to Tau (AUCtau) of PF-05251749 - Days 1, 7 and 14.|AUCtau referred to the area under the curve from time 0 to time tau, the dosing interval, where tau equaled to 24 hours on Days 1, 7 and 14.|Days 1 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 48h), 7 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24h) and 14 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 48h).|The PK parameter population was defined as all enrolled participants treated who received at least 1 dose of PF-05251749 and had at least 1 of the PK parameters of interest measured.|||nanogram*hour/mililiter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2558515|NCT02691702|Secondary|Maximum Plasma Concentration (Cmax) of PF-05251749 - Days 1, 7 and 14|Maximum plasma concentration (Cmax) of PF-05251749 was observed directly from data on Days 1, 7 and 14.|Days 1 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 48h), 7 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24h) and 14 (0, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 48h).|The Pharmacokinetic (PK) concentration population was defined as all enrolled participants treated who received at least 1 dose of PF-05251749 and had at least 1 measureable concentration.|||nanogram/mililiter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2558516|NCT02691702|Primary|Number of Participants With New/Intensified Neurological Examination Findings|The number of participants with new-intensified neurological examination findings were reported.|Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14).|The safety analysis set included all participants who received at least 1 dose of study treatment.|||Participants|||Number
2558517|NCT02691702|Primary|Number of Participants With New/Intensified Physical Examination Findings|Physical examination included examination of ears, eyes, gastrointestinal, head, heart, lungs, lymph nodes, mouth, musculoskeletal, nose, skin. The number of participants with new-intensified physical examination findings were reported.|Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14).|The safety analysis set included all participants who received at least 1 dose of study treatment.|||Participants|||Number
2558518|NCT02691702|Primary|Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Criteria (Increase From Baseline)|Number of participants with ECG Data of increase from baseline meeting the following criteria was reported: Criterion A: maximum PR interval increase from baseline percentage change (PctChg)>=25/50%; Criterion B: maximum QRS complex increase from baseline PctChg >=50%; Criterion C: maximum QTC interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate) increase from baseline 30<=change<60 msec; Criterion D: maximum QTC interval increase from baseline change >=60 msec; Criterion E: maximum QTCF (Fridericia's correction) interval increase from baseline 30<=change<60; Criterion F: maximum QTCF interval increase from baseline change >=60 msec. Baseline was defined as the average of the triplicate measurements prior to dosing on Day 1.|Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14).|The safety analysis set included all participants who received at least 1 dose of study treatment.|||Participants|||Number
2558519|NCT02691702|Primary|Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Criteria (Absolute Values)|Number of participants with ECG data of absolute values meeting categorical criteria was reported as following: Criterion A: maximum PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization) >= 300 msec; Criterion B: maximum QRS complex (time from Q wave to the end of S wave, corresponding to ventricle depolarization)>= 140 msec; Criterion C: Maximum QT interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole)>= 500 msec; Criterion D: maximum QTC interval (QT interval corrected for heart rate) 450-<480 msec; Criterion E: maximum QTC interval 480-<500 msec; Criterion F: maximum QTC interval >=500 msec; Criterion G: maximum QTCF interval (QT interval corrected for heart rate using Fridericia's formula) 450 -< 480 msec; Criterion H: maximum QTCF interval 480 -< 500 msec; Criterion I: maximum QTCF interval >=500 msec.|Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14).|The safety analysis set included all participants who received at least 1 dose of study treatment.|||Participants|||Number
2558520|NCT02691702|Primary|Number of Participants With Vital Signs Data Meeting Categorical Criteria (Decrease From Baseline)|Number of participants with vital signs data of increase from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in supine systolic BP >= 30 mmHg; Criterion B: maximum decrease from baseline in supine diastolic BP >= 20 mmHg. Baseline was defined as the last available recording prior to dosing.|Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14).|The safety analysis set included all participants who received at least 1 dose of study treatment.|||Participants|||Number
2558521|NCT02691702|Primary|Number of Participants With Vital Signs Data Meeting Categorical Criteria (Increases From Baseline)|Number of participants with vital signs data of increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in supine systolic BP >= 30 mmHg; Criterion B: maximum increase from baseline in supine diastolic BP >= 20 mmHg. Baseline was defined as the last available recording prior to dosing.|Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14).|The safety analysis set included all participants who received at least 1 dose of study treatment.|||Participants|||Number
2558522|NCT02691702|Primary|Number of Participants With Vital Signs Data Meeting Categorical Criteria (Absolute Values)|Number of participants with vital signs data of absolute values meeting categorical criteria was reported as following: (1) Supine systolic BP < 90 mmHg; (2) Supine Diastolic BP < 50 mmHg; (3) Supine Pulse Rate < 40 BPM ; (4) Supine Pulse Rate > 120 BPM.|Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14).|The safety analysis set included all participants who received at least 1 dose of study treatment.|||Participants|||Number
2558538|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Degree of Comfortableness Showing Skin|"Questions were answered seven days after treatment by the participant. The question is Thinking about how comfortable you felt showing your skin while using this product, would you say that you were"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558605|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress: Nucleoplasmic Bridges|Evidences of clinically definite oxidative stress: nucleoplasmic bridges confirmed by Cytokinesis-block Micronucleus Test|before induction,clamping removal ,operation ending,1,3,7days post surgery||||number of nucleoplasmic bridges/1000 BN||Standard Deviation|Mean
2558523|NCT02691702|Primary|Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)|The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, MCV, MCH, MCHC, platelets, white blood cell count, absolute lymphocytes, absolute total neutrophils, absolute basophils, absolute eosinophils and absolute monocytes), coagulation (PPT, prothrombin, PT international, ratio and fibrinogen, liver function(total bilirubin, direct bilirubin, aspartate, AST, Alanine, ALT, gamma GT, alkaline phosphatase, total protein and albumin), renal function (blood urea nitrogen, creatinine, HDL cholesterol, LDL cholesterol, triglycerides), Electrolytes (sodium, potassium, chloride, calcium, phosphate, venous bicarbonate), clinical chemistry (glucose, creatinine kinase), urinalysis dipstick (urine PH, urine glucose, urine ketones, urine protein, urine blood, urine urobilinogen, urine nitrite, urine leukocyte, esterase), urinalysis microscopy (urine RBC, urine WBC, urine casts, urine bacteria), miscellaneous (absolute lymphocyte marker CD4, CD8, CD19)|Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14).|The safety analysis set included all participants who received at least 1 dose of study treatment.|||Participants|||Number
2558524|NCT02691702|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) (Treatment Related)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; The event has a causal relationship with the treatment or usage.|Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14).|The safety analysis set included all participants who received at least 1 dose of study treatment.|||Participants|||Number
2558525|NCT02691702|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) (All Causalities)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.|Day 1 to follow-up visit (28 calendar days after the last dose of investigational product on Day 14).|The safety analysis set included all participants who received at least 1 dose of study treatment.|||Participants|||Number
2558526|NCT02691702|Primary|Number of Participants With New Onset and Worsening of Post-baseline Suicidality for Columbia Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced any of the following 1: completed suicide, 2: suicide attempt (response of yes on actual attempt), 3: preparatory acts toward imminent suicidal behavior (yes on aborted attempt, interrupted attempt, preparatory acts or behavior), 4: any suicidal behavior or ideation, suicidal ideation (yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), 7: self-injurious behavior, no suicidal intent (yes on has participant engaged in non-suicidal self-injurious behavior). The new onset and worsening of post-baseline suicidality for C-SSRS was reported."|Days 0, 7, 14, 16, and follow-up visit (28 calender days after the last dose of investigational product on Day 14).|The safety analysis set included all participants who received at least 1 dose of study treatment.|||Participants|||Number
2558527|NCT02691702|Primary|Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16- Mood|The Bond and Lader Visual Analogue Scales (VAS) monitored the subjective mood of each participant on 16 mood scales. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered (example, alert/drowsy; calm/excited; content/tensed). The individual responses from the 16 mood scales were then combined to make three affective dimensions/subscales a) alertness (average of 9 items [total range 0 to 100, where each item is ordered so that higher scores indicated more alertness]), b) mood (average of 2 items [total range 0 to 100, where higher scores indicated elevated mood]), and c) calmness (average of 5 items [total range 0 to 100, where higher scores indicated more calmness]). Baseline is defined as the last available recording prior to dosing on Day 1.|Baseline (0h on Day 1), Day 1 (2h), Day 4 (1.5h), Day 7 (0h, 2h), Day 10 (1.5h), Day 14 (0h, 2h), Day 15 (0h) and Day 16 (0h).|The safety analysis set included all participants who received at least 1 dose of study treatment.|||Units on a scale||Standard Deviation|Mean
2558528|NCT02691702|Primary|Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16 - Calmness|The Bond and Lader Visual Analogue Scales (VAS) monitored the subjective mood of each participant on 16 mood scales. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered (example, alert/drowsy; calm/excited; content/tensed). The individual responses from the 16 mood scales were then combined to make three affective dimensions/subscales a) alertness (average of 9 items [total range 0 to 100, where each item is ordered so that higher scores indicated more alertness]), b) mood (average of 2 items [total range 0 to 100, where higher scores indicated elevated mood]), and c) calmness (average of 5 items [total range 0 to 100, where higher scores indicated more calmness]). Baseline is defined as the last available recording prior to dosing on Day 1.|Baseline (0h on Day 1), Day 1 (2h), Day 4 (1.5h), Day 7 (0h, 2h), Day 10 (1.5h), Day 14 (0h, 2h), Day 15 (0h) and Day 16 (0h).|The safety analysis set included all participants who received at least 1 dose of study treatment.|||Units on a scale||Standard Deviation|Mean
2558529|NCT02691702|Primary|Change From Baseline for Bond and Lader Visual Analogue Scale (BL-VAS) on Days 1, 4, 7, 10, 14, 15 and 16 - Alertness|The Bond and Lader Visual Analogue Scales (VAS) monitored the subjective mood of each participant on 16 mood scales. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered (example, alert/drowsy; calm/excited; content/tensed). The individual responses from the 16 mood scales were then combined to make three affective dimensions/subscales a) alertness (average of 9 items [total range 0 to 100, where each item is ordered so that higher scores indicated more alertness]), b) mood (average of 2 items [total range 0 to 100, where higher scores indicated elevated mood]), and c) calmness (average of 5 items [total range 0 to 100, where higher scores indicated more calmness]). Baseline is defined as the last available recording prior to dosing on Day 1.|Baseline (0h on Day 1), Day 1 (2h), Day 4 (1.5h), Day 7 (0h, 2h), Day 10 (1.5h), Day 14 (0h, 2h), Day 15 (0h) and Day 16 (0h).|The safety analysis set included all participants who received at least 1 dose of study treatment.|||Units on a scale||Standard Deviation|Mean
2558530|NCT02691572|Secondary|Level of Patient Satisfaction|Assessed at 24 h using a 5-point scale (1 = very unsatisfied, 2 = unsatisfied, 3 = fair, 4 = satisfied, 5 = very satisfied).|24 h|||||||
2558531|NCT02691572|Secondary|Number of Patients With Pruritis|The occurrence of pruritis will be assessed by yes/no question and recorded.|24 h|||||||
2558539|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Degree of Sleep|"Questions were answered seven days after treatment by the participant. The question is Thinking about how well you slept when using this product, would you say your sleep was?"|7 days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558540|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Skin on Waking|"Questions were answered seven days after treatment by the participant. The question is Thinking about your experience when using this product, how would you describe your skin upon awakening?"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558541|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Degree of Distraction by Itchy Eczema Skin|"Questions were answered seven days after treatment by the participant. The question is Thinking about your experience while using this product, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558542|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Skin Feels Smooth|"Questions were answered seven days after treatment by the participant. The question is This product leaves my skin feeling smooth"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558543|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Slept Better|"Questions were answered seven days after treatment by the participant. The question is I slept better due to less itching or skin discomfort"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558544|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Moisturized All Day|"Questions were answered seven days after treatment by the participant. The question is This product leaves my skin feeling moisturized all day"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558545|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Skin Feels Soft|"Questions were answered seven days after treatment by the participant. The question is This product makes my skin feel soft"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558546|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Product Does Not Rub Off on Sheets|"Questions were answered seven days after treatment by the participant. The question is This product does not rub off on sheets"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558547|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Skin Feels Touchable|"Questions were answered seven days after treatment by the participant. The question is This product makes my skin feel touchable"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558548|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Skin Feels Moisturized|"Questions were answered seven days after treatment by the participant. The question is This product leaves my skin feeling moisturized"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558549|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Shield for Skin|"Questions were answered seven days after treatment by the participant. The question is This product feels like a shield for my skin"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558550|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Long Lasting Moisture|"Questions were answered seven days after treatment by the participant. The question is This product provides long lasting moisture to my skin"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558551|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Comfortable Showing Skin|"Questions were answered seven days after treatment by the participant. The question is I feel comfortable showing my skin"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558552|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Calmer Skin on Waking|"Questions were answered seven days after treatment by the participant. The question is I wake up to calmer skin"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558553|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Distracted by Itchy Skin|"Questions were answered seven days after treatment by the participant. The question is I'm less distracted by my itchy skin"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558554|NCT02691507|Secondary|Participant Questionnaire 7 Days After Treatment - Skin Feels Calm|"Questions were answered seven days after treatment by the participant. The question is This product calms my skin"|Seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558555|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Degree of Comfortableness Showing Skin|"Questions were answered six hours after treatment by the participant. The question is Thinking about how comfortable you felt showing your skin after using this product, would you say that you were"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2561285|NCT02652390|Secondary|11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score|Score for the 11-item DASH scale, a measure of activity limitations related to the upper extremity. Score range 0 (best) to 100 (worst)|5-7 years||||score on a scale||Standard Deviation|Mean
2558556|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Degree of Distraction by Itchy Eczema Skin|"Questions were answered six hours after treatment by the participant. The question is Thinking about your experience after using this product, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558557|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Skin Feels Smooth|"Questions were answered six hours after treatment by the participant. The question is This product leaves my skin feeling smooth"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558558|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Skin Feels Soft|"Questions were answered six hours after treatment by the participant. The question is This product makes my skin feel soft"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558559|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Skin Feels Touchable|"Questions were answered six hours after treatment by the participant. The question is This product makes my skin feel touchable"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558560|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Skin Feels Moisturized|"Questions were answered six hours after treatment by the participant. The question is This product leaves my skin feeling moisturized"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558561|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Shield for Skin|"Questions were answered six hours after treatment by the participant. The question is This product feels like a shield for my skin"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558562|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Comfortable Showing Skin|"Questions were answered six hours after treatment by the participant. The question is I feel comfortable showing my skin"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558563|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Distracted by Itchy Skin|"Questions were answered six hours after treatment by the participant. The question is I'm less distracted by my itchy skin"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558564|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Calms Skin|"Questions were answered six hours after treatment by the participant. The question is This product calms my skin"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558565|NCT02691507|Secondary|Participant Questionnaire 6 Hours After Treatment - Long Lasting Moisture|"Questions were answered six hours after treatment by the participant. The question is This product provides long lasting moisture"|Six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558566|NCT02691507|Secondary|Participant Questionnaire 5 Hours After Treatment - Skin Feeling Soft|"Questions were answered five hours after treatment by the participant. The question is This product leaves my skin feeling soft"|Five hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558567|NCT02691507|Secondary|Participant Questionnaire 5 Hours After Treatment - Long Lasting Moisture|"Questions were answered five hours after treatment by the participant. The question is This product provides long lasting moisture"|Five hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558568|NCT02691507|Secondary|Participant Questionnaire 4 Hours After Treatment - Skin Feeling Soft|"Questions were answered four hours after treatment by the participant. The question is This product leaves my skin feeling soft"|Four hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558569|NCT02691507|Secondary|Participant Questionnaire 4 Hours After Treatment - Long Lasting Moisture|"Questions were answered four hours after treatment by the participant. The question is This product provides long lasting moisture"|Four hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558570|NCT02691507|Secondary|Participant Questionnaire Immediately After Treatment - Product Does Not Sting|"Questions were answered immediately after treatment by the participant. The question is This product does not sting when applied"|0 Days - Immediately after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558571|NCT02691507|Secondary|Participant Questionnaire Immediately After Treatment - Moisturized Skin|"Questions were answered immediately after treatment by the participant. The question is This product leaves my skin feeling immediately moisturized"|0 Days - Immediately after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558572|NCT02691507|Secondary|Participant Questionnaire Immediately After Treatment - Calm Skin|"Questions were answered immediately after treatment by the participant. The question is This product calms my skin"|0 Days - Immediately after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558573|NCT02691507|Secondary|Participant Questionnaire Immediately After Treatment - Product Fast Absorbing|"Questions were answered immediately after treatment by the participant. The question is This product is fast absorbing"|0 Days - Immediately after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558574|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin Over Past 2 Days|"Questions were answered before treatment by the participant. The question is Thinking about how comfortable you felt showing your skin during the last two days, would you say that you were"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558575|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment - Sleep During Past 2 Days|"Questions were answered before treatment by the participant. The question is Thinking about how well you slept during the past two days, would you say your sleep was?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558576|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment - Skin Upon Waking Over Past 2 Days|"Questions were answered before treatment by the participant. The question is Thinking about your experience over the past two days, how would you describe your skin upon awakening?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558577|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Eczema Skin Over Past 2 Days|"Questions were answered before treatment by the participant. The question is Thinking about your experience over the past two days, please describe your degree of being distracted by your itchy, eczema skin. Would you say you were"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558578|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment - Soft Skin|"Questions were answered before treatment by the participant. The question is My skin feels soft"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558579|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment - Touchable Skin|"Questions were answered before treatment by the participant. The question is My skin feels touchable"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558580|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment - Moisturized Skin|"Questions were answered before treatment by the participant. The question is My skin feels moisturized"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558581|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment - Comfortable Showing Skin|"Questions were answered before treatment by the participant. The question is I feel comfortable showing my skin"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558582|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment - Smooth Skin|"Questions were answered before treatment by the participant. The question is My skin feels smooth"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558583|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment - Calmer Skin|"Questions were answered before treatment by the participant. The question is I wake up to calmer skin"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558584|NCT02691507|Secondary|Participant Questionnaire on Day 0 Pre-treatment - Distracted by Itchy Skin|"Questions were answered before treatment by the participant. The question is I'm less distracted by my itchy skin"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2558585|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
2558586|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 6 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
2558587|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 5 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to five hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
2558588|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 4 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to four hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
2558589|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 3 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to three hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
2558590|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 2 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to two hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
2558591|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement 1 Hour After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to one hour after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
2558592|NCT02691507|Secondary|Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Baseline to Immediately following treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
2558593|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 7 Days After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to seven days after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2558594|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 6 Hours After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to six hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2558595|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 5 Hours After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to five hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2558596|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 4 Hours After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to four hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2558597|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 3 Hours After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to three hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2558598|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 2 Hours After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to two hours after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2558599|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score 1 Hour After Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to one hour after treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2558600|NCT02691507|Primary|Change From Baseline in the Itch Assessment Score Immediately Following Treatment|The severity of the itch was assessed by the subject using a 0-10 cm visual analog scale (VAS) where 0 = no itch and 10 = worst itch imaginable.|Baseline to immediately following treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2558601|NCT02691468|Secondary|the Incidence of Critical Malposition of DLTs|The displacement of DLT was determined by changes in tracheal and bronchial distances, obtained by subtracting supine measurements from lateral measurements and subtracting measurements at start of surgery from measurements at the end of surgery, respectively. The critical malposition was defined when the DLT was required repostion for successful OLV during position change|from supine to lateral decubitus position||||participants|||Number
2558602|NCT02691468|Primary|the Incidence of Clinically Significant Displacement of DLTs During Change of Patient Position|The tracheal distance was defined as the distance between the distal tip of the tracheal lumen and tracheal carina whereas the bronchial distance was defined as that between the bronchial carina and distal tip of endobronchial lumen. The displacement of DLT was determined by changes in tracheal and bronchial distances, obtained by subtracting supine measurements from lateral measurements and subtracting measurements at start of surgery from measurements at the end of surgery, respectively. Clinically significant displacement was defined when the DLT was deviated by more than 10 mm from the initial correct position, regardless of the direction of displacement.|from supine to lateral decubitus position||||Participants|||Count of Participants
2558603|NCT02691416|Secondary|Montreal Cognitive Assessment (MoCA)|A questionnaires is used to assess the cognitive function of patients in clinical,the total range was 0-30,and 27-30 were considered as normal value,<27 were considered as recognitive dysfunction.|before induction,1,3,7days post surgery||||units on a scale||Standard Deviation|Mean
2558604|NCT02691416|Secondary|Mini Mental State Examination (MMSE)|A questionnaires is used to assess the cognitive function of patients in clinical,the total range was 0-30,and 27-30 were considered as normal value,<27 were considered as recognitive dysfunction.|before induction,1,3,7days post surgery||||units on a scale||Standard Deviation|Mean
2558607|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography|Evidences of clinically definite oxidative stress :α- tocopherol,γ- tocopherol which was used to assess the antioxidant defense.|before induction,after clamping removal ,operation ending ,1,3,7days post surgery||||ug/ml||Standard Deviation|Mean
2558608|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress:Micronuclei|Evidences of clinically definite oxidative stress:micronuclei confirmed by Cytokinesis-block Micronucleus Test|before induction,clamping removal ,operation ending,1,3,7days post surgery||||number of micronuclei/1000 BN cells||Standard Deviation|Mean
2558609|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA|Evidences of clinically definite oxidative stress:8-isoprostane,as a reliable biomarkers of lipid peroxidation|before induction, after clamping removal,operation ending,1,3,7days post surgery||||pg/ml||Standard Deviation|Mean
2558610|NCT02691416|Primary|Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit|Evidences of clinically definite oxidative stress :Superoxide dismutase activity, Hydroxyl radical|before induction,after clamping removal ,operation ending ,1,3,7days post surgery||||U/ml||Standard Deviation|Mean
2558611|NCT02691260|Primary|Weight Change From Baseline to 24 Weeks|Measured in pounds|24 weeks||||Pounds (lbs.)||Standard Deviation|Mean
2558612|NCT02691143|Secondary|Change in Numeric Pain Rating Scale (NPRS)|Subjects rate their pain on the Numeric Pain Rating Scale (NPRS), a scale from 0-10, 0 being none and 10 being the worst imaginable.|3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hours||||units on a scale||Full Range|Mean
2558613|NCT02691143|Primary|Change in Cervical Range of Motion|Six cervical ranges of motion values will be recorded utilizing the Acumar DataCapture hand-held dual inclinometer. Range of motion will be measured at maximum (max) degrees and average degrees of 6 trials and will include: flexion (F), extension (E), left side-bending (LSB), right side-bending (RSB), left rotation (LR), and right rotation (RR).|3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hours||||degrees||Full Range|Mean
2558614|NCT02691013|Secondary|Measures of the Sound Levels in the Patient's Room|Sound meter was placed at bedside in each patient room. This meter measured and recorded the sound level in decibels every two seconds.|3 days||2019-12-31|12/2019||||
2558615|NCT02691013|Secondary|Measures of Light Quality in the Patient's Room|Light meter placed at bedside in patient room; this meter measured and recorded the light level in lux for ever minutes.|3 days||2019-12-31|12/2019||||
2558616|NCT02691013|Secondary|Length of ICU Stay||Duration of hospital admission||||days||Inter-Quartile Range|Median
2558617|NCT02691013|Secondary|Length of Hospital Stay||Duration of hospital admission||||days||Inter-Quartile Range|Median
2558618|NCT02691013|Secondary|Average Daily Critical Care Pain Observation Tool (CPOT)|average daily pain level using the CPOT Participants can score from 0 to 6 on the CPOT scale, with 0 being no pain (calm, comfortable), and 6 representing significant pain/agitation.|10 days||2019-12-31|12/2019||||
2558619|NCT02691013|Secondary|Number of Participants With Delirium|Measured twice daily over the course of the ICU stay using the Confusion Assessment Method instrument|Twice daily for up to 10 days||||Participants|||Count of Participants
2558620|NCT02691013|Primary|Total Duration of Sleep|Participants wore an actigraphy device on their wrist for the duration of their ICU stay. This device continuously measures activity, and thus estimates sleep time.|Daily for up to 10 days|Due to funding & logistical constraints, only a subset of subjects would've been able to do the electroencephalography (EEG) monitoring used for sleep assessment. Thus, Total Duration of Sleep was not measured and we focused on our a priori secondary outcome of incident delirium, a change made before the start of data collection or analysis.||||||
2558621|NCT02691013|Primary|Duration of Delirium|Measured twice daily during the ICU stay using the Confusions Assessment Method instrument.|Twice daily for up to 10 days||||hours||Inter-Quartile Range|Median
2558622|NCT02690974|Secondary|Percentage of Participants on Guideline Recommended Dose of Beta-blockers and MRAs Over Time|To describe the adherence to guideline recommended dosing of beta-blockers and MRAs at 6 and 12 months of treatment of LCZ696. Only descriptive analysis done.|Baseline, Month 6 and Month 12|The Safety Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Participants|||Count of Participants
2558623|NCT02690974|Secondary|Median Time to Reach LCZ696 200 mg|To describe the time of up-titration for each dose (24 mg sacubitril / 26 mg valsartan bid and 49 mg sacubitril / 51 mg valsartan bid) of LCZ696. Only descriptive analysis done.|Baseline, Week 2, Week 4, Month 3, Month 6 and Month 12|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Days||95% Confidence Interval|Median
2558624|NCT02690974|Secondary|Time to Each Up-titration to LCZ696 100 mg and LCZ696 200 mg|To describe the time of up-titration for each dose (24 mg sacubitril / 26 mg valsartan bid and 49 mg sacubitril / 51 mg valsartan bid) of LCZ696. Only descriptive analysis done.|Baseline, Week 2, Week 4, Month 3, Month 6 and Month 12|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Days||Standard Deviation|Mean
2558625|NCT02690974|Secondary|Change From Baseline in the Six Minute Walk Test (6MWT) at Month 6 and Month 12|The impact of LCZ696 on functional exercise capacity was measured by the Six Minute Walk Test at 6 and 12 months. The 6MWT measures the distance an individual is able to walf over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. Only descriptive analysis done.|Baseline, Month 6 and Month 12|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Meter (m)||Standard Deviation|Mean
2558626|NCT02690974|Secondary|Percentage of Participants With Down-titration Changes From LCZ696 200 mg During 12 Months of Treatment|The impact of the titration scheme on the tolerability of patients maintained on LCZ696 97 mg sacubitril / 103 mg valsartan bid was defined as the number of down-titration during the 12 months treatment period. Dow-titration schemes considered for the analysis are 200 mg to 100 mg; 100 mg to 50 mg; and 50 mg to 0 mg (i.e. treatment discontinuation). The down-titration scheme of 50mg to 0 mg was taken in account in this analysis to ensure to reflect all actual changes in dose. Only descriptive analysis done.|Month 12|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Participants|||Count of Participants
2558627|NCT02690974|Secondary|Percentage of Participants Requiring Down-titration From LCZ696 200 mg|The impact of the titration scheme on the tolerability of patients maintained on LCZ696 97 mg sacubitril / 103 mg valsartan bid was defined as the percentage of patients on LCZ696 200mg requiring down-titration. Only descriptive analysis done.|Month 12|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Percentage of Participants||95% Confidence Interval|Number
2558628|NCT02690974|Secondary|Percentage of Participants on LCZ696 200 mg Bid at Month 12|The tolerability of LCZ696 was defined as the percentage of patients on LCZ696 at the dose of 97 mg sacubitril / 103 mg valsartan twice daily (bid) who did not experience down titration or treatment discontinuation because of adverse events while on this dose at month 12. Only descriptive analysis done.|Month 12|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Percentage of Participants||95% Confidence Interval|Number
2558629|NCT02690974|Primary|Percentage of Participants on LCZ696 200 mg Bid at Month 6|The tolerability of LCZ696 was defined as the percentage of patients on LCZ696 at the dose of 97 mg sacubitril / 103 mg valsartan twice daily (bid) who did not experience down titration or treatment discontinuation because of adverse events while on this dose at month 6. Only descriptive analysis done.|Month 6|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Percentage of Participants||95% Confidence Interval|Number
2558630|NCT02690948|Secondary|Progression-free Survival (PFS)|The progression-free survival (PFS) will be participants with unresectable or metastatic basal cell carcinoma (BCC) after treatment with A) pembrolizumab monotherapy and B) pembrolizumab in combination with vismodegib, will be reported as the percentage of participants without progression 1 year after the start of treatment.|1 year||||Participants|||Count of Participants
2558631|NCT02690948|Secondary|Overall Survival (OS)|The overall survival (OS) participants with unresectable or metastatic basal cell carcinoma (BCC) after treatment with A) pembrolizumab monotherapy and B) pembrolizumab in combination with vismodegib, will be reported as the number and percentage of participants remaining alive 1 year after the start of treatment.|1 year||||Participants|||Count of Participants
2558632|NCT02690948|Secondary|Duration of Response (DOR)|"The duration of response (DOR) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria in participants receiving A) pembrolizumab monotherapy and B) pembrolizumab in combination with vismodegib, assessed as the median value for subjects who complete 9 and 18 weeks of treatment.~RECIST criteria:~Complete Response (CR) = Disappearance of all target lesions~Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions~Overall Response (OR) = CR + PR~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)~Stable disease (SD) = Small changes that do not meet any of the above criteria"|up to 2 years||||Weeks||Full Range|Median
2558633|NCT02690948|Secondary|Related Adverse Events|Adverse events were assessed for relationship to pembrolizumab treatment. The outcome is reported as the number (without dispersion) of Grade 3 or higher adverse events considered possibly, probably, or definitely-related to pembrolizumab treatment,.|up to 2 years||||Related adverse events|||Number
2558634|NCT02690948|Secondary|Percentage of Participants Experiencing Adverse Events|Incidence of Adverse Events is assessed as the percentage of participants receiving treatment who experience adverse events of any grade, in participants receiving A) pembrolizumab monotherapy and B) pembrolizumab in combination with vismodegib. Enrolled participants receiving at least one dose of study agent and with at least one follow-up evaluation will be included.|up to 2 years||||percentage of participants|||Number
2558635|NCT02690948|Primary|Overall Response Rate (ORR)|"The overall response rate (ORR) of participants with unresectable or metastatic basal cell carcinoma (BCC) after treatment with A) pembrolizumab monotherapy and B) pembrolizumab in combination with vismodegib, will be assessed as the percentage of participants with partial response (PR) or complete response (CR) as determined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria, after 9 and 18 weeks of treatment. ORR is calculated as the ratio of patients with CR or PR as a percentage of the participants evaluable for OR.~RECIST criteria:~Complete Response (CR) = Disappearance of all target lesions~Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions~Overall Response (OR) = CR + PR~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)~Stable disease (SD) = Small changes that do not meet any of the above criteria"|18 weeks||||Percentage of participants||95% Confidence Interval|Number
2558636|NCT02690935|Secondary|Quality of Life During the Whole Period of Observation|This is the mean of the score to 3 daily quality of life questions: 1) Did you sleep well (0 to 3), 2) Are you able to work (0 to 3), 3) How do you feel today (0 to 3). The minimum daily score is 0 (good quality of life) and the maximum is 9 (bad quality of life). The mean of the daily scores was calculated over the whole period of observation (up to 6 months) for each patient.|QoL scores were assessed daily for up to 6 months|ITT population|||units on a scale||Standard Deviation|Mean
2558637|NCT02690935|Primary|Area Under the Curve [AUC](Total Score of Symptoms Taking Into Account the Total 5 Symptom Score (T5SS) and Consumption of Rescue Medications (RM) on the Y-axis, and Time on X Axis)|Area under the curve [AUC] (total score of symptoms taking into account the Total 5 Symptom Score (T5SS) and consumption of rescue medications (RM) on the Y-axis versus time on X axis). T5SS was the sum of the 5 individual scores (min-max=0-15). It was corrected each day as a function of consumption of rescue medications (RM): oral antihistamine (+2 points), local treatment (nasal or eye; +1 point), ocular cromoglycate (+1 point) and nasal topical corticosteroids (+1 point). An increase in the total corrected score was considered as a worsening of the allergic symptoms.|Up to Month 6 (end of pollen season)|ITT population|||T5SS score corrected with RM * day||Standard Deviation|Mean
2558638|NCT02690727|Secondary|Pharmacokinetic Parameters|Peak Plasma Concentration (Cmax)|up to 24 hours post-dose.|Subjects who provided evaluable data for both treatments|||nanogram per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2558639|NCT02690727|Secondary|Number of Participants Who Were Evaluated for Adverse Events|Number of Participants Who Were Evaluated for Adverse Events as Assessed by CTCAE v4.0|7 days|Healthy volunteers|||Participants|||Count of Participants
2559655|NCT02674204|Primary|Change in Global Circumferential Strain (GCS) Measured by Cardiac MRI (CMRI)||baseline to 12 months post initiation of statin intervention|As accrual fell well below target, change in global circumferential strain (GCS) measured by Cardiac MRI (CMRI) was not calculated.||||||
2558640|NCT02690727|Primary|Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))|Pharmacokinetic parameters (Area under the plasma concentration versus time curve (AUC)) AUC0-T of RP6530 in fed and fast state.|up to 24 hours post-dose.|subjects who provided evaluable data for both treatments (Fasting and fed conditions)|||nanogram*hour per millilitre (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2558641|NCT02690701|Secondary|Dermatology Life Quality Index (DLQI) Total Score|"Change from baseline in the DLQI total score~Summary of analysis of change from baseline in DLQI at Week 12 and statistical analysis (using Analysis of Covariance) of change from baseline in DLQI at Week 12~The higher the score, the more quality of life is impaired.~0 - 1 no effect at all on patient's life 2 - 5 small effect on patient's life 6 - 10 moderate effect on patient's life 11 - 20 very large effect on patient's life 21 - 30 extremely large effect on patient's life"|baseline, 12 weeks|FAS|||scores on a scale||Standard Deviation|Mean
2558642|NCT02690701|Secondary|Investigator's Global Assessment Modified 2011 (IGA Mod 2011) Score of 0 or 1|"percentage of participants with IGA mod 2011 score of 0 or 1 (yes, no)~Investigator's Global Assessment modified 2011 (IGA mod 2011) score of 0 or 1~Statistical analysis (Cochran-Mantel-Haenszel test) of Novartis Investigator's Global Assessment Modified 2011 0 or 1 response by visit (Non-responder Imputation)"|week 12|FAS|||percentage of participants|||Number
2558643|NCT02690701|Secondary|Psoriasis Area and Severity Index 100 (PASI100)|Percentage of participants with PASI100 response (yes, no) PASI100 response = complete clearing of psoriasis|week 12|FAS|||percentage of participants|||Number
2558644|NCT02690701|Secondary|Psoriasis Area and Severity Index 90 (PASI 90)|Percentage of participants with PASI90 response (yes, no) PASI90 response = at least a 90& improvement (reduction) in PASI score compared to baseline|week 12|FAS|||percentage of participants|||Number
2558645|NCT02690701|Secondary|Area and Severity Index 75 (PASI 75)|"Percentage of participants with PASI75 response (yes, no) PASI75 response = at least a 75% improvement (reduction) in PASI score compared to baseline~Psoriasis Area and Severity Index ( PASI) is a tool for measuring the severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease)."|week 12|FAS|||percentage of participants|||Number
2558646|NCT02690701|Secondary|VLDL Size|Change from baseline in Very Low Density Lipoprotein (VLDL) Cholesterol size|baseline, 12 weeks|FAS|||nm||Standard Deviation|Mean
2558647|NCT02690701|Secondary|Change VLDL Particle Total|Change in Very-low-density lipoprotein (VLDL) cholesterol level|baseline, 12 weeks|FAS|||nmol/L||Standard Deviation|Mean
2558648|NCT02690701|Secondary|Change in TNF-α|Change in Tumor necrosis factor (TNF, tumor necrosis factor alpha, TNFα is a marker of inflammation Also written as TNF-alpha|baseline, 12 weeks|FAS|||pg/mL||Standard Deviation|Mean
2558649|NCT02690701|Secondary|Change in Triglycerides|Triglycerides are a marker of cardiometabolic function|baseline, 12 weeks|FAS|||mg/dL||Standard Deviation|Mean
2558650|NCT02690701|Secondary|LDL Size|Change from baseline in Low Density Lipoprotein (LDL) Cholesterol size|baseline, 12 weeks|FAS|||nm||Standard Deviation|Mean
2558651|NCT02690701|Secondary|LDL Particle Total|Change from baseline in Low Density Lipoprotein (LDL) Cholesterol Particle Total|baseline, 12 weeks|FAS|||nmol/L||Standard Deviation|Mean
2558652|NCT02690701|Secondary|Change in Leptin|Change from baseline in Leptin a marker of adiposity|baseline, 12 weeks|FAS|||pg/mL||Standard Deviation|Mean
2558653|NCT02690701|Secondary|Change LDL Cholesterol|Change from baseline in Low-Density Lipoprotein (LDL) Cholesterol as a marker of cardiometabolic function|baseline, 12 weeks|FAS|||mg/dL||Standard Deviation|Mean
2558654|NCT02690701|Secondary|Change in Intermediate-Density Lipoprotein (IDL) Particle|Intermediate-density lipoprotein (IDL) particle is a marker of cardiometabolic function|baseline, 12 weeks|FAS|||nmol/mL||Standard Deviation|Mean
2558655|NCT02690701|Secondary|Change in IL-6|Interleukin 6 (IL-6) is a marker of inflammation|baseline, 12 weeks|FAS|||pg/mL||Standard Deviation|Mean
2558656|NCT02690701|Secondary|Change in IL-18|Interleukin-18 (IL-18) is a marker predictive of diabetes|baseline, 12 weeks|FAS|||pg/mL||Standard Deviation|Mean
2558657|NCT02690701|Secondary|Change in IL-2 Receptor A|Interleukin-2 Receptor A (IL-2RA) is a marker predictive of diabetes|baseline, 12 weeks|FAS|||pg/mL||Standard Deviation|Mean
2558658|NCT02690701|Secondary|HOMA-IR|Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) Insulin [uIU/mL (mU/L)] x Glucose (mg/dL) = HOMA-IR|baseline, 12 weeks|FAS|||HOMA-IR units||Standard Deviation|Mean
2558659|NCT02690701|Secondary|HDL Size|Change from baseline in High Density Lipoprotein (HDL) Cholesterol size|baseline, 12 weeks|FAS|||nm||Standard Deviation|Mean
2558660|NCT02690701|Secondary|HDL Particle Total|Change from baseline in High Density Lipoprotein (HDL) Cholesterol Particle Total|baseline, 12 weeks|FAS|||μmol/L||Standard Deviation|Mean
2558661|NCT02690701|Secondary|Change in HDL Function (Cholesterol Efflux)|"Change from baseline in High Density Lipoprotein (HDL) Cholesterol (cholesterol efflux) , a cardiometabolic biomarker~Ratio of the pleated serum to removal of Cholesterol"|baseline, 12 weeks|FAS|||ratio||Standard Deviation|Mean
2558662|NCT02690701|Secondary|Change in HDL Cholesterol|Change from baseline in High Density Lipoprotein (HDL) Cholesterol, a cardiometabolic biomarker|baseline, 12 weeks|FAS|||mg/dL||Standard Deviation|Mean
2558663|NCT02690701|Secondary|Change in GlycA|Change from baseline in glycoprotein acetylation (GlycA), a marker of inflammation|baseline, 12 weeks|FAS|||μmol/L||Standard Deviation|Mean
2558664|NCT02690701|Secondary|Change in Ferritin|Change from baseline in Ferritin, a marker predictive of diabetes|baseline, 12 weeks|FAS|||ng/mL||Standard Deviation|Mean
2558665|NCT02690701|Secondary|Change in Fetuin A|Change from baseline in Fetuin A, a marker predictive of diabetes|baseline, 12 weeks|FAS|||ng/mL||Standard Deviation|Mean
2558666|NCT02690701|Secondary|Change in Cholesterol|Change from baseline in Cholesterol level|baseline, 12 weeks|FAS|||mg/dL||Standard Deviation|Mean
2558667|NCT02690701|Secondary|Change in CRP|Change from baseline in C reactive protein (CRP), a measure of inflammation|baseline, 12 weeks|FAS|||mg/L||Standard Deviation|Mean
2558668|NCT02690701|Secondary|Change in Apolipoprotein B|Change from baseline in Apolipoprotein B levels, a marker predictive of diabetes|baseline, 12 weeks|FAS|||ng/mL||Standard Deviation|Mean
2558669|NCT02690701|Secondary|Change in Adiponectin Total|Change from baseline in Adiponectin to measure adiposity|baseline, 12 weeks|FAS|||ng/mL||Standard Deviation|Mean
2558670|NCT02690701|Primary|Aortic Vascular Inflammation as Measured by FDG-PET/CT|"Change from baseline in the target to background ratio from the whole aorta.~Effect of secukinumab 300 mg subcutaneous (sc) compared to placebo on aortic vascular inflammation with respect to the change from baseline in the target (arterial vascular uptake) to background (venous blood pool) ratio from the aorta. The primary analysis time point was at Week 12.~Increased aortic vascular inflammation as measured by (18F) fluorodeoxyglucose positron emission tomography with computer assisted tomography (FDG-PET/CT)"|baseline, 12 weeks|Full Analysis Set (FAS) included all participants assigned medication. Patients inappropriately randomized (eg, IRT was called in error for randomization of a screen failed patient) were excluded from this analysis set. Following intent-to-treat principle, participants were analyzed according to treatment they were assigned to at randomization|||target to background ratio (TBR)||Standard Deviation|Mean
2558671|NCT02690207|Secondary|Number of Subjects With at Least One Suspected Herpes Zoster (HZ) Case(s)|"A suspected case of HZ was defined as a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations).~Clinically confirmed HZ episode is suspected HZ episode confirmed by the Investigator/Delegate."|From Month 0 until study end (Month 14, i.e. 12 months post dose 2)|This analysis was performed on Total vaccinated cohort, which included all subjects with at least one HZ/su vaccine administration documented for whom data were available.|||Participants|||Count of Participants
2558672|NCT02690207|Primary|Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related pIMDs=pIMDs assessed by the investigator as related to the vaccination.|From Month 0 until study end (Month 14, i.e. 12 months post dose 2)|This analysis was performed on Total vaccinated cohort, which included all subjects with at least one HZ/su vaccine administration documented for whom data were available.|||Participants|||Count of Participants
2558673|NCT02690207|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related=SAE assessed by the investigator as related to the vaccination.|From Month 0 until study end (Month 14, i.e. 12 months post dose 2)|This analysis was performed on Total vaccinated cohort, which included all subjects with at least one HZ/su vaccine administration documented for whom data were available.|||Participants|||Count of Participants
2558674|NCT02690207|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related=AE assessed by the investigator as related to the vaccination.|During 30 days (Days 0-29) after any vaccination (across doses)|This analysis was performed on Total vaccinated cohort, which included all subjects with at least one HZ/su vaccine administration documented for whom data were available.|||Participants|||Count of Participants
2558675|NCT02690194|Secondary|Number of Injections|Average number of injections for patients that indicated that they previously have had injections|Pre-therapy/Pre-procedure|Patients that have had injections in the past|||Number of injections||Standard Deviation|Mean
2558676|NCT02690194|Secondary|Injection Experiences|Indication of prior injection experiences|Pre-therapy/Pre-procedure||||Participants|||Count of Participants
2558677|NCT02690194|Secondary|Exercise in Last Hour|Indication of if the patient has exercised in the last hour|Pre-therapy/Pre-procedure||||Participants|||Count of Participants
2558678|NCT02690194|Secondary|Eat in Last Hour|Indication of if the patient has eaten in the last hour|Pre-therapy/Pre-procedure||||Participants|||Count of Participants
2558679|NCT02690194|Secondary|Drink in Last Hour|Indication of if the patient has had a drink in the last hour|Pre-therapy/Pre-procedure||||Participants|||Count of Participants
2558680|NCT02690194|Secondary|Perceived Pain Level of the Procedure as Assessed by the Wong-Baker FACES Pain Rating Scale|"Perceived pain level of the procedure as assessed by the Wong-Baker FACES pain rating scale 1-10. A score of 1 indicates no hurt (a better outcome) while a score of 10 indicates hurts worst (worst outcome)."|Immediately post-procedure||||score on a scale||Standard Deviation|Mean
2558681|NCT02690194|Secondary|Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure|Post-therapy/pre-procedure change in stress level measured by blood pressure measured in mmHg. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure.|Post-therapy/Pre-procedure|No data were collected for the control group in this Outcome Measure.|||mmHg||95% Confidence Interval|Mean
2558682|NCT02690194|Secondary|Post-therapy/Pre-procedure Change in Anxiety Level|Post-therapy/Pre-procedure change in anxiety level measure by the State-Trait Anxiety Inventory. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure. The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety.|Post-therapy/pre-procedure|No data were collected for the control group in this Outcome Measure.|||score on a scale||95% Confidence Interval|Mean
2558683|NCT02690194|Secondary|Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate|Post-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure.|Post-therapy/pre-procedure|No data were collected for the control group in this Outcome Measure.|||Breaths per minute||95% Confidence Interval|Mean
2558684|NCT02690194|Secondary|Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse|Post-therapy/pre-procedure change in stress level measured by pulse in beats per minute. Value at prost-therapy/pre-procedure minus value at pre-therapy/pre-procedure.|Post-therapy/pre-procedure|No data were collected for the control group in this Outcome Measure|||Beats per minute||95% Confidence Interval|Mean
2558685|NCT02690194|Primary|Pre-therapy/Pre-procedure Anxiety Level|Pre-therapy/pre-procedure anxiety level measure by the State-Trait Anxiety Inventory. The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety.|Pre-therapy/pre-procedure||||score on a scale||Standard Deviation|Mean
2558689|NCT02690181|Secondary|Geometric Mean ELISA Anti-Diphtheria Antibody Concentrations in All Subjects|Geometric Mean ELISA Anti-Diphtheria Antibody Concentrations (95%CI) in All Subjects at Day 1 Pre-vaccination in the V98_06 study or V98_06E1 for the Naive Group and at Day 61 Post-vaccination in Study V98_06E1. Anti-diphtheria antibody testing was not performed in this study because no diphtheria vaccine was administered in the study and also because data from other Cross Reactive Material(CRM)-based vaccines demonstrate that administration has not resulted in a decline in anti-diphtheria antibody concentrations.|At Day 1 (V98_06 or V98_06E1) and Day 61|Anti-diphtheria antibody testing was not performed in this study because no diphtheria vaccine was administered in the study and also because data from other CRM-based vaccines demonstrate that administration has not resulted in a decline in anti-diphtheria antibody concentrations.||||||
2558690|NCT02690181|Secondary|Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ|The Geometric Mean Antibody Concentrations of GBS Serotype III in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.|At Day 1, Day 31 and Day 61|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.|||µg/mL||95% Confidence Interval|Geometric Mean
2558691|NCT02690181|Secondary|Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ|The Geometric Mean Antibody Concentrations of GBS Serotype Ib in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.|At Day 1, Day 31 and Day 61|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.|||µg/mL||95% Confidence Interval|Geometric Mean
2558692|NCT02690181|Secondary|Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ|The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in subjects with prevaccination serotype-specific GBS antibody equal or greater than LLQ were estimated for at Day 1, Day 31 and Day 61.|At Day 1, Day 31 and Day 61|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.|||µg/mL||95% Confidence Interval|Geometric Mean
2558693|NCT02690181|Secondary|Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ|The Geometric Mean Antibody Concentrations of GBS Serotype III in subjects with prevaccination serotype-specific GBS antibody less than LLQ were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.|At Day 1, Day 31 and Day 61|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.|||µg/mL||95% Confidence Interval|Geometric Mean
2558694|NCT02690181|Secondary|Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ|The Geometric Mean Antibody Concentrations of GBS Serotype Ib in subjects with prevaccination serotype-specific GBS antibody less than LLQ were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.|At Day 1, Day 31 and Day 61|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.|||µg/mL||95% Confidence Interval|Geometric Mean
2558695|NCT02690181|Secondary|Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ)|The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in subjects with prevaccination serotype-specific GBS antibody less than LLQ were estimated for at Day 1, Day 31 and Day 61.|At Day 1, Day 31 and Day 61|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.|||µg/mL||95% Confidence Interval|Geometric Mean
2558696|NCT02690181|Secondary|Geometric Mean Antibody Concentrations of GBS Serotype III|The Geometric Mean Antibody Concentrations of GBS Serotype III in All Subjects were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.|At Day 1, Day 31 and Day 61|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.|||µg/mL||95% Confidence Interval|Geometric Mean
2558697|NCT02690181|Secondary|Geometric Mean Antibody Concentrations of GBS Serotype Ib|The Geometric Mean Antibody Concentrations of GBS Serotype Ib in All Subjects were estimated for at Day 1, Day 31 and Day 61. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.|At Day 1, Day 31 and Day 61|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.|||µg/mL||95% Confidence Interval|Geometric Mean
2561286|NCT02652390|Secondary|Palmar Pain Score|Score for pain in the proximal palm and related activity limitations, range 0 (worst) to 100 (best).|5-7 years||||score on a scale||Standard Deviation|Mean
2558698|NCT02690181|Secondary|Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia|The Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in All Subjects were estimated for at Day 1, Day 31 and Day 61.|At Day 1, Day 31 and Day 61.|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.|||µg/mL||95% Confidence Interval|Geometric Mean
2558699|NCT02690181|Secondary|Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31|Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype III at day 31 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.|At Day 31|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.|||Percentage of subjects||95% Confidence Interval|Number
2558700|NCT02690181|Secondary|Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31|Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ib at day 31 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.|At Day 31|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.|||Percentage of subjects||95% Confidence Interval|Number
2558701|NCT02690181|Secondary|Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31|Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ia at Day 31 post-vaccination, as measured by ELISA.|At Day 31|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.|||Percentage of subjects||95% Confidence Interval|Number
2558702|NCT02690181|Primary|Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal|"An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: Death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. Medically attended adverse event is defined as an adverse event that leads to a visit to a healthcare provider and AEs leading to withdrawal are defined as adverse events leading to study or vaccine withdrawal."|Day 1 to Day 181|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, received the study vaccination and with any unsolicited adverse event data.|||Participants|||Count of Participants
2558703|NCT02690181|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|The number of subjects with any unsolicited AEs from the day of vaccination in study V98_06E1 to Day 31. An unsolicited adverse event is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject. Possibly Related AE definition: the administration of the investigational vaccine and AE are considered reasonably related in time and the AE could be explained by exposure to the investigational vaccine or by other causes. Probably Related AE definition: exposure to the investigational vaccine and AE are reasonably related in time and no alternative explanation has been identified.|Day 1 to Day 31|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, received the study vaccination and with any unsolicited adverse event data.|||Participants|||Count of Participants
2558704|NCT02690181|Primary|Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs)|Threshold for Erythema, Swelling and Induration: None (0 mm), Any (>= 1 mm).|Day 1 to Day 7|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, received the study vaccination and with any solicited adverse event data and/or indicators of solicited adverse events (e.g., use of analgesics/antipyretics).|||Participants|||Count of Participants
2558705|NCT02690181|Primary|Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61|Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype III at day 61 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.|At Day 61|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.|||Percentage of subjects||95% Confidence Interval|Number
2558706|NCT02690181|Primary|Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61|Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ib at day 61 post-vaccination. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.|At Day 61|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.in this study.|||Percentage of subjects||95% Confidence Interval|Number
2558707|NCT02690181|Primary|Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61|Percentage of subjects who reach pre-defined sequential serotype-specific serum antibody levels for serotype Ia at Day 61 post-vaccination, as measured by Enzyme-linked immunosorbent Assay (ELISA).|At Day 61|All screened subjects who provided informed consent and baseline screening measurements, received a subject ID, received study vaccine according to the protocol, and parent study vaccine (non-naïve subjects), and provided immunogenicity data at Day 1, Day 31 or Day 61 in this study.|||Percentage of subjects||95% Confidence Interval|Number
2558708|NCT02689973|Secondary|Physical Activity Self-efficacy (PA Self-efficacy)|"Physical activity self-efficacy (T1 and T2) was measured with 9 items (e.g., 'I am able to maintain regular MVPA even if I would have to reorganize my daily life'; Luszczynska et al., 2011).~Number of Items: 9~Response format: Responses ranged from 1 ('definitely not') to 4 ('exactly true').~Scoring: the total score of 9 items divided by 9~Scoring formula: the sum score for the 9 items divided by 9, i.e. {item #1 + item #2 + item #3 + item #4+ item #5 + item #6 + item #7 + item #8 + item #9} : 9~The range for score (i.e. the sum score of 9 items divided by 4): minimum = 1, maximum = 4~Interpretation: Higher scores indicate better results (the higher levels of PA self-efficacy)"|Baseline to 2-month follow-up||||units on a scale||Standard Deviation|Mean
2558709|NCT02689973|Secondary|The Use of Physical Activity Planning (the Use of Planning)|"Use of physical activity planning was measured with four items (e.g., 'I have my own plan regarding when to engage in exercise of moderate-to-vigorous intensity'; Schwarzer et al., 2008).~Number of Items: 4~Response format: Responses ranged from 1 ('definitely not') to 4 ('exactly true').~Scoring: the total score of 4 items~Scoring formula: the sum score for the 4 items divided by 4, i.e. {item #1 + item #2 + item #3 + item #4} : 4~The range for the score (i.e. the sum score of 4 items divided by 4): minimum = 1, maximum = 4~Interpretation: Higher scores indicate better results (the more frequent use of planning)"|Baseline to 2-month follow-up||||units on a scale||Standard Deviation|Mean
2558710|NCT02689973|Secondary|Moderate-to-vigorous Physical Activity (MVPA)|"Items from Godin and Shephard's (1985) Leisure-Time Exercise Questionnaire (e.g., 'Considering a 7-day period [a week], how many times on the average do you do the following kinds of exercise for more than 15 minutes during your free time: strenuous exercise [heart beats rapidly], i.e. running, jogging, hockey, soccer, basketball, cross-country skiing, vigorous swimming, vigorous long distance bicycling').~Number of Items: 2~Response format: open ended, the participant indicated the number of 15 min blocks of physical activity.~Scoring: the total (sum) score of 2 items~Scoring formula: the sum score for the number of minutes of MVPA per week, i.e. individual score = {response to item #1 x 15} + {response to item # 2 x 15})~The range for the score (i.e. the sum score of 2 items): minimum = 0, maximum = 42~Interpretation: Higher scores indicate better results (more minutes of MVPA per week)"|Baseline to 14-month follow-up||||units on a scale||Standard Deviation|Mean
2558711|NCT02689973|Primary|Body Fat Tissue|bioimpedance (BIA) method (Kyle et al., 2004), which determines the electrical impedance of an electric current through body tissues. Fat tissue was estimated with Schaefer equation for BIA which is considered a reliable index of body fat in adolescent from primarily white backgrounds (Cleary et al., 2008).|Baseline to 14-month follow-up||||percentage of body fat||Standard Deviation|Mean
2558712|NCT02689804|Secondary|Time to Maximum Concentration of Serum UPA|(Tmax) calculated in women with normal and obese BMI|Up to 24 hours||||h||Standard Deviation|Mean
2558713|NCT02689804|Secondary|Time to Maximum Concentration of Serum LNG|(Tmax) calculated in women with normal and obese BMI|Up to 24 hours||||h||Standard Deviation|Mean
2558714|NCT02689804|Secondary|Maximum Concentration of Serum UPA|(Cmax) calculated in women with normal and obese BMI|Up to 24 hours||||ng/mL||Inter-Quartile Range|Mean
2558715|NCT02689804|Secondary|Maximum Concentration of Serum LNG|(Cmax) calculated in women with normal and obese BMI|Up to 24 hours||||ng/mL||Inter-Quartile Range|Mean
2558716|NCT02689804|Secondary|Clearance of Serum UPA|(Cl) calculated in women with normal and obese BMI|Up to 24 hours||||L/h||Inter-Quartile Range|Mean
2558717|NCT02689804|Secondary|Clearance of Serum LNG|(Cl) calculated in women with normal and obese BMI|Up to 24 hours||||L/h||Inter-Quartile Range|Mean
2558718|NCT02689804|Secondary|Elimination Half-life of Serum UPA|(t1/2) calculated in women with normal and obese BMI|Up to 24 hours|Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.|||h||Inter-Quartile Range|Mean
2558719|NCT02689804|Secondary|Elimination Half-life of Serum LNG|(t1/2) calculated in women with normal and obese BMI|Up to 24 hours|Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.|||h||Inter-Quartile Range|Mean
2558720|NCT02689804|Primary|Area Under the Curve From Time 0 to 24 Hours of Serum UPA Concentration|UPA-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.|Up to 24 hours|Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.|||ng*h/mL||Inter-Quartile Range|Mean
2558721|NCT02689804|Primary|Area Under the Curve From Time 0 to 24 Hours of Serum LNG Concentration|LNG-EC PK parameter (AUC 0-24 h) in women with normal and obese BMI women.|Up to 24 hours|Cross-over study: 16 normal-BMI and 16 obese-BMI enrolled and each participant received both drugs in random order.|||ng*h/mL||Inter-Quartile Range|Mean
2558722|NCT02689492|Secondary|Correlation Between Patients' Satisfaction and Resource Utilization|"Correlation indexes were calculated between treatment satisfaction domain scores of TSQM-9 and healthcare resource consumption at 12-month follow-up visit.~Hospitalization - Number of hospitalizations not in ICU during observation period per patient, Specialist Outpatient - Number of specialist outpatient visits per patient during observation period, E = Effectiveness at 12 months and C = Convenience at 12 months"|12-month follow-up visit|FAS|||Spearman’s correlation coefficients|||Number
2558731|NCT02689219|Secondary|Progression Free Survival|Duration of time from the start of treatment to time of documented progression or death. Patients who did not progress or die were censored on their last evaluation date. Kaplan-Meier methods will be used and the median and 95% confidence intervals will be calculated.|Up to 2 years|All patients who received at least one dose of study medication.|||months||95% Confidence Interval|Median
2558826|NCT02688764|Secondary|Serum iPTH Levels at Each Time Point and Change From Baseline||From baseline through study completion, up to 34 weeks after treatment start date|Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.|||pmol/L||Standard Deviation|Mean
2558723|NCT02689492|Secondary|The Health Care Resources Utilization According to the Italian National Health Service (INHS) During a 12-month Observation Period|"Health care resources consumption related to COPD, COPD exacerbations and COPD-drug-related adverse events was computed during observational period in terms of number of (inward and day-hospital) hospitalizations, number of emergency room accesses, number of General Practitioner (GP) visits, specialist visits and laboratory tests or examinations.~Hospitalization (Number Analyzed) - Number of hospitalizations not in ICU during observation period per patient, Emergency room accesses (Number Analyzed) - Number of Emergency room accesses during observation period per patient, Specialist Outpatient Visits (Number Analyzed) - Number of specialist outpatient visits per patient during observation period, GP Visits (Number Analyzed) - Number of general practitioner visits per patient during observation period, Laboratory Tests (Number Analyzed) - Number of tests per patient during observation period."|Up to 12 months|FAS|||Number of events||Standard Deviation|Mean
2558724|NCT02689492|Secondary|The Relationship Between Treatment Satisfaction - Global Satisfaction Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.|"A regression model was estimated, where the dependent variable was the global satisfaction domain score and the independent variables were: age and gender (at enrollment), number of exacerbations, relevant spirometry parameters (Forced expiratory volume in the 1st second (FEV1) % of the predicted), level of dyspnea (MMRC score classes: 0-4), impact of COPD on a patient's life (CAT total score: 0-40) and treatment adherence (MMAS-4 score classes: 0-4) collected during observational period. Because dependent variable was collected at each study visit, repeated measures model was estimated taking into account all available values for dependent and independent variables.~Mean is actually estimate of beta values.Visit 1 is at enrollment, visit 2 is at 6 months and visit 3 is at 12 months."|Up to 12 months|FAS|||Beta coefficient estimate||Standard Error|Mean
2558725|NCT02689492|Secondary|The Relationship Between Treatment Satisfaction - Convenience Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.|"A regression model was estimated, where the dependent variable was the convenience domain score and the independent variables were: age and gender (at enrollment), number of exacerbations, relevant spirometry parameters (Forced expiratory volume in the 1st second (FEV1) % of the predicted), level of dyspnea (MMRC score classes: 0-4), impact of COPD on a patient's life (CAT total score: 0-40) and treatment adherence (MMAS-4 score classes: 0-4) collected during observational period. Because dependent variable was collected at each study visit, repeated measures model was estimated taking into account all available values for dependent and independent variables.~Mean is actually estimate of beta values. Visit 1 is at enrollment, visit 2 is at 6 months and visit 3 is at 12 months."|Up to 12 months|FAS|||Beta coefficient estimate||Standard Error|Mean
2558726|NCT02689492|Secondary|The Relationship Between Treatment Satisfaction - Effectiveness Domain and Demographics, Clinical Parameters and Patient Reported Outcome (PROs) During a 12-month Observation Period.|"A regression model was estimated, where the dependent variable was the effectiveness domain score and the independent variables were: age and gender (at enrollment), number of exacerbations, relevant spirometry parameters (Forced expiratory volume in the 1st second (FEV1) % of the predicted), level of dyspnea (MMRC score classes: 0-4), impact of COPD on a patient's life (CAT total score: 0-40) and treatment adherence (MMAS-4 score classes: 0-4) collected during observational period. Because dependent variable was collected at each study visit, repeated measures model was estimated taking into account all available values for dependent and independent variables.~Mean is actually estimate of beta values. Visit 1 is at enrollment, visit 2 is at 6 months and visit 3 is at 12 months."|Up to 12 months|FAS|||Beta coefficient estimate||Standard Error|Mean
2558727|NCT02689492|Secondary|Measurements of Patient Disease Perception, Adherence to COPD Treatment, Health Status and Dyspnea Over 12-months Observation Period.|"Patient's disease perception was evaluated by Brief Illness Perception Questionnaire (B-IPQ) consist 8 questionnaires rated 1 - 10 response scale. Mean total score ranges from 8-80, where a greater score indicated a more threatening view of COPD.~Adherence was measured using Morisky Medication Adherence Scale, 4 items (MMAS-4) questionnaire which consists of 4 questions. Items are summed to give an adherence score ranging from 0 to 4, where a higher score indicated a greater adherence grade.~Patients' health status was measured using the COPD Assessment Test (CAT) questionnaire that consists of 8-items in which patients can choose a score from 0 to 5. The total score ranges from 0 to 40, where a higher score indicated a worst impact of symptoms on the patient's daily activities.~Dyspnea was measured using Modified Medical Research Council Dyspnea Scale (MMRC) with a 0-to-4 grading system. It had 0-to-4 grading system, with higher score indicating a higher level of dyspnea."|At enrollment visit, 6-month follow-up visit and 12-month follow-up visit|FAS|||Unit on Scale||Standard Deviation|Mean
2558728|NCT02689492|Primary|The Patients' Satisfaction With Chronic Obstructive Pulmonary Disease (COPD) Medical Treatments During a 12-month Observation Period|"Patient's self-reported satisfaction or dissatisfaction with pharmacological treatments was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4, a validated instrument. The TSQM has total 9 items (TSMQ-9) with responses to nearly all items rated on a 5-point or 7-point rating scale that provide scores on 3 scales: effectiveness (items #1 #2 #3), convenience (items #4 #5 #6) and global satisfaction (items #7 #8 #9).~The TSQM-9 domain scores were calculated as recommended by the instrument authors. (i) Effectiveness = [(item1 + item2 + item3) - 3]/18*100, (ii) Convenience = [(item4 + item5 + item6) - 3]/18*100 and (iii) Global satisfaction = [(item7 + item8 + item9) - 3]/14*100.~Each domain score can be calculated only if all the three items considered in the calculation of that score are not missing. The TSQM-9 domain scores range from 0 to 100, with higher scores representing higher satisfaction on that domain."|At enrollment visit, 6-month follow-up visit and 12-month follow-up visit.|Full Analysis Set (FAS): FAS includes all enrolled patients evaluable for baseline data analysis.|||Unit on Scale||Standard Deviation|Mean
2558729|NCT02689219|Secondary|Number of Patients With Treatment Related Adverse Events Grade 3 or Above|Number of unique patients who had a treatment related (possible, probable or definite) adverse event with grade >= 3 using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Up to 2 years|All patients who received at least one dose of study medication.|||Participants|||Count of Participants
2558730|NCT02689219|Secondary|Overall Survival|Duration of time from the start of treatment to time of death due to any causes. Patients who did not die were censored on their last known alive date. Kaplan-Meier methods will be used and the median and 95% confidence intervals will be calculated.|Up to 2 years|All patients who received at least one dose of study medication.|||months||95% Confidence Interval|Median
2558732|NCT02689219|Primary|Objective Response (Percent of Patients With Complete Response or Partial Response)|Measured by RECIST v1.1 and tumor markers (AFP and BhCG). CR - disappearance of all target lesions and normalization of serum tumor markers for at least 4 weeks. When only evidence of disease is elevated serum tumor markers, then values must fall below the upper limit of normal for the assay and remain at that level for at least 4 weeks. PR - at least a 30% decrease in the sum of the diameters of target lesions compared to the baseline sum diameters for at least 2 measurements 1 month apart with the serum markers as stable/decreasing. When only evidence of disease is elevated serum tumor markers, then values must fall >=90% below baseline pretreatment levels for BhCG or 50% decrease below baseline pretreatment levels for AFP and persist for 6 weeks. If both tumor markers are elevated and one falls below 90% the other should fall at least below 50% of baseline pretreatment levels.The percent of patients with objective response and its 95% exact confidence interval will be provided.|Up to 1 year|All patients who received at least one dose of study medication and at least one evaluable assessment after treatment.|||percentage of patients||95% Confidence Interval|Number
2558733|NCT02689206|Secondary|Change From Baseline in Weight at Post-dialysis|Vital sign measurements including weight were taken in a seated or semi-supine position in the dialysis chair. Weight was measured post-dialysis. Post-dialysis Baseline value was defined as SBP and DBP value obtained post-dialysis at Week -2. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||kg||Standard Deviation|Mean
2558734|NCT02689206|Secondary|Change From Baseline in Pulse Rate Value at Pre-dialysis and Post-dialysis|Vital sign measurements including pulse rate were taken in a seated or semi-supine position in the dialysis chair. Pulse rate was measured pre-dialysis and post-dialysis. Pre-dialysis Baseline value was defined as pulse rate value obtained pre-dialysis on Day 1. Post-dialysis Baseline value was defined as pulse rate value obtained post-dialysis at Week -2. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Beats per minute||Standard Deviation|Mean
2558735|NCT02689206|Secondary|Change From Baseline in SBP and DBP Values at Pre-dialysis and Post-dialysis|Vital sign measurements including SBP and DBP were taken in a seated or semi-supine position in the dialysis chair. SBP and DBP were measured pre-dialysis and post-dialysis. Pre-dialysis Baseline value was defined as SBP and DBP value obtained pre-dialysis on Day 1. Post-dialysis Baseline value was defined as SBP and DBP value obtained post-dialysis at Week -2. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||mmHg||Standard Deviation|Mean
2558736|NCT02689206|Secondary|Weight Values at Post-dialysis|Vital sign measurements including weight values were taken in a seated or semi-supine position in the dialysis chair. Weight was measured post-dialysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Kilograms (kg)||Standard Deviation|Mean
2558737|NCT02689206|Secondary|Pulse Rate Values at Pre-dialysis and Post-dialysis|Vital sign measurements including pulse rate values were taken in a seated or semi-supine position in the dialysis chair. Pulse rate was measured pre-dialysis and post-dialysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Beats per minute||Standard Deviation|Mean
2558738|NCT02689206|Secondary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values at Pre-dialysis and Post-dialysis|Vital sign measurements including SBP and DBP were taken in a seated or semi-supine position in the dialysis chair at specific time points. SBP and DBP were measured pre-dialysis and post-dialysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2558739|NCT02689206|Secondary|Change From Baseline in ECG Parameters Including PR Interval, QRS Duration, QT Interval and QTcB|Single measurements of 12-lead ECG were obtained in supine position using an ECG machine to measure PR interval, QRS duration, QT interval and QTcB. Week -4 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values at Day 29 minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Day 29|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Milliseconds (msec)||Standard Deviation|Mean
2559656|NCT02673944|Primary|Accurate Vesical PRessure|To validate that the Peritron+ digital readings are identical to the urodynamic readings (+/- 3 cm H2O) in the sitting position.|During a routine urodynamic study (1 hr approx)||||cm H2O||Standard Deviation|Mean
2558740|NCT02689206|Secondary|Change From Baseline in ECG Mean Heart Rate|Single measurements of 12-lead ECG were obtained in supine position using an ECG machine to measure HR. Week -4 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values at Day 29 minus Baseline value.|Baseline and Day 29|Safety Population|||Beats per minute||Standard Deviation|Mean
2558741|NCT02689206|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Indicated Time Points|Single measurements of 12-lead ECG were obtained in supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT interval. Number of participants who had abnormal non clinically significant (NCS) and abnormal clinically significant (CS) ECG findings at Baseline (Week -4) and Day 29 are presented.|Up to Day 29|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Participants|||Number
2558742|NCT02689206|Secondary|Change From Baseline in Leukocytes, Neutrophils, Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets Levels|Blood samples were collected from participants to evaluate clinical hematology parameters including leukocytes, neutrophils, basophils, eosinophils, lymphocytes, monocytes, platelets. Change from Baseline in clinical hematology parameters at Day 15, Day 29, Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||10^12 cells/L||Standard Deviation|Mean
2558743|NCT02689206|Secondary|Change From Baseline in Erythrocyte Distribution Width Levels|Blood samples were collected from participants to evaluate clinical hematology parameters including erythrocyte distribution width. Change from Baseline in clinical hematology parameters at Day 15, Day 29, Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Percentage of width||Standard Deviation|Mean
2558744|NCT02689206|Secondary|Change From Baseline in MCV Levels|Blood samples were collected from participants to evaluate clinical hematology parameters including MCV. Change from Baseline in clinical hematology parameters at Day 15, Day 29, Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||fL||Standard Deviation|Mean
2558745|NCT02689206|Secondary|Change From Baseline in MCHC Levels|Blood samples were collected from participants to evaluate clinical hematology parameters including MCHC. Change from Baseline in clinical hematology parameters at Day 15, Day 29, Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||g/L||Standard Deviation|Mean
2558746|NCT02689206|Secondary|Change From Baseline in MCH Levels|Blood samples were collected from participants to evaluate clinical hematology parameters including MCH. Change from Baseline in clinical hematology parameters at Day 15, Day 29, Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Pg||Standard Deviation|Mean
2558747|NCT02689206|Secondary|Erythrocyte Distribution Width Levels in Blood at Indicated Time Points|Erythrocyte distribution width levels were assessed as a clinical hematology laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Percentage of width||Standard Deviation|Mean
2558748|NCT02689206|Secondary|Mean Corpuscular Volume (MCV) Levels in Blood at Indicated Time Points|Serum MCV levels were assessed as a clinical hematology laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Femtoliter (fL)||Standard Deviation|Mean
2560356|NCT02664272|Secondary|Number of Hips With Leg Length Discrepancy|Leg length discrepancy was measured preoperatively and postoperatively shortly after insertion of the SL-PLUS™ MIA Ti/HA femoral hip stem.|Preoperative, directly postoperative (approximately 3 months)||||hips|hips||Count of Units
2558749|NCT02689206|Secondary|Mean Corpuscular Hemoglobin Concentration (MCHC) Levels in Blood at Indicated Time Points|Serum MCHC levels were assessed as a clinical hematology laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||g/L||Standard Deviation|Mean
2558750|NCT02689206|Secondary|Mean Corpuscular Hemoglobin (MCH) Levels in Blood at Indicated Time Points|Serum MCH levels were assessed as a clinical hematology laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Pg||Standard Deviation|Mean
2558751|NCT02689206|Secondary|Leukocytes, Neutrophils, Basophils, Eosinophils,Lymphocytes, Monocytes, Platelet Levels in Blood at Indicated Time Points|Serum leukocytes, neutrophils, basophils, eosinophils, lymphocytes, monocytes and platelet levels were assessed as a clinical hematology laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 43|Safety population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||10^12 cells/L||Standard Deviation|Mean
2558752|NCT02689206|Secondary|Change From Baseline in Bilirubin, Direct Bilirubin, Indirect Bilirubin Levels|Blood samples were collected from participants to evaluate clinical chemistry parameters including bilirubin, direct bilirubin and indirect bilirubin. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the Daprodustat 25mg treatment group for all PK population and safety population analyses.|||µmol/L||Standard Deviation|Mean
2558753|NCT02689206|Secondary|Change From Baseline in ALT, AST, Alk. Phosph. Levels|Blood samples were collected from participants to evaluate clinical chemistry parameters including ALT, AST, Alk. phosph. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||IU/L||Standard Deviation|Mean
2558754|NCT02689206|Secondary|Change From Baseline in Albumin and Protein Levels|Blood samples were collected from participants to evaluate clinical chemistry parameters including albumin and protein. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||g/L||Standard Deviation|Mean
2558755|NCT02689206|Secondary|Change From Baseline in Sodium, Potassium, Glucose, Calcium and Phosphate Levels|Blood samples were collected from participants to evaluate clinical chemistry parameters including sodium, potassium, glucose, calcium and phosphate. Change from Baseline in clinical chemistry parameters at Day 15, Day 29 and Day 43 are presented. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Mmol/L||Standard Deviation|Mean
2558756|NCT02689206|Secondary|Bilirubin, Direct Bilirubin and Indirect Bilirubin Levels in Blood at Indicated Time Points|Serum bilirubin, direct bilirubin and indirect bilirubin levels were assessed as a clinical chemistry laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2558765|NCT02689206|Secondary|Change From Baseline in Reticulocyte Hemoglobin (CHr)|Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect Dapro three times weekly dose regimens on CHr. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. The change from Baseline at Day 29 post-Baseline time point was calculated.|Baseline and Day 29|ITT Population|||Picograms (pg)||Standard Deviation|Mean
2561287|NCT02652390|Primary|Symptom Severity Score|Change in symptom severity score from baseline to 5 to 7 years. Score range 1 (no symptoms) to 5 (most severe symptoms).|5-7 years||||score on a scale||Standard Deviation|Mean
2558757|NCT02689206|Secondary|Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Alkaline Phosphatase (Alk. Phosph) Levels in Blood at Indicated Time Points|Serum ALT, AST and alk. phosph. levels were assessed as a clinical chemistry laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 43|Safety Population One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||IU/L||Standard Deviation|Mean
2558758|NCT02689206|Secondary|Albumin and Protein Levels in Blood at Indicated Tme Points|Serum albumin and protein levels were assessed as a clinical chemistry laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||grams per liter (g/L)||Standard Deviation|Mean
2558759|NCT02689206|Secondary|Sodium, Potassium, Glucose, Calcium, Phosphate Levels in Blood at Indicated Time Points|Serum sodium, potassium, glucose, corrected calcium and phosphate levels were assessed as a clinical chemistry laboratory parameter from Baseline up to follow up visit at Day 43. Day 1 values were considered as Baseline values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2558760|NCT02689206|Secondary|Number of Participants With AEs and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function.|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Participants|||Number
2558761|NCT02689206|Secondary|Number of Participants Who Discontinued Study Treatment|Reasons of study treatment discontinuation included adverse events (AEs), protocol deviation, participants reached protocol defined stopping criteria, physician decision and withdrawal by participants. Number of participants who discontinued study treatment are presented. Analysis was performed on Safety Population which comprised of all participants who received at least one dose of study treatment.|Up to Day 43|Safety Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Participants|||Number
2558762|NCT02689206|Secondary|Time to Reach Cmax (Tmax) and Apparent Terminal Half-life (t1/2) of Dapro|"Blood samples were collected at indicated time points for PK analysis of dapro. The data from each PK sampling day was combined to generate a single profile, and normalized to a 24-hour period to create a Day 1 profile for NCA. Metabolite plasma concentrations were analyzed but PK parameters could not be calculated as the metabolites were partially eliminated through dialysis and the dialysis start and end times were not consistent on both PK days. Therefore, a representative metabolite PK profile could not be generated. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)."|Pre-dose on Day 1; 6-10 hours, 7-11 hours, 8-12 hours, 9-13 hours post dose on Day 15; pre-dose and 1, 2, 3 hours post-dose on Day 29|PK Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||Hour||Geometric Coefficient of Variation|Geometric Mean
2558763|NCT02689206|Secondary|Maximum Observed Concentration of Dapro in Plasma (Cmax)|"Blood samples were collected at indicated time points for PK analysis of dapro. The data from each PK sampling day was combined to generate a single profile, and normalized to a 24-hour period to create a Day 1 profile for NCA. Metabolite plasma concentrations were analyzed but PK parameters could not be calculated as the metabolites were partially eliminated through dialysis and the dialysis start and end times were not consistent on both PK days. Therefore, a representative metabolite PK profile could not be generated."|Pre-dose on Day 1; 6-10 hours, 7-11 hours, 8-12 hours, 9-13 hours post dose on Day 15; pre-dose and 1, 2, 3 hours post-dose on Day 29|PK Population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2558764|NCT02689206|Secondary|Area Under the Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) and AUC From Time Zero to Infinity (AUC[0-inf]) of Dapro|"Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of dapro. The data from each PK sampling day was combined to generate a single profile, and normalized to a 24-hour period to create a Day 1 profile for non-compartmental analysis (NCA). Metabolite plasma concentrations were analyzed but PK parameters could not be calculated as the metabolites were partially eliminated through dialysis and the dialysis start and end times were not consistent on both PK days. Therefore, a representative metabolite PK profile could not be generated. The analysis was performed on PK Population, which comprised of all participants from whom a PK sample has been obtained and analyzed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)."|Pre-dose on Day 1; 6-10 hours, 7-11 hours, 8-12 hours, 9-13 hours post dose on Day 15; pre-dose and 1, 2, 3 hours post-dose on Day 29|PK Population. One participant who was randomized to the placebo group, erroneously received 25mg daprodustat treatment throughout the 29-day treatment period. This subject is counted within the daprodustat 25mg treatment group for all PK population and safety population analyses.|||hour into nanograms/milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2558766|NCT02689206|Secondary|Change From Baseline in Reticulocyte Count|Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect Dapro three times weekly dose regimens on reticulocyte count. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. The change from Baseline at Day 29 post-Baseline time point was calculated.|Baseline and Day 29|ITT Population|||Percentage of reticulocyte||Standard Deviation|Mean
2558767|NCT02689206|Secondary|Change From Baseline in Red Blood Cell (RBC) Count|Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect Dapro three times weekly dose regimens on RBC count. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-dose visit values minus Baseline value. The change from Baseline at Day 29 post-Baseline time point was calculated.|Baseline and Day 29|ITT Population|||10^12 cells/L||Standard Deviation|Mean
2558768|NCT02689206|Secondary|Change From Baseline in Hematocrit Levels|Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect Dapro three times weekly dose regimens on hematocrit. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-dose visit values minus Baseline value. The change from Baseline at Day 29 post-Baseline time point was calculated.|Baseline and Day 29|ITT Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
2558769|NCT02689206|Secondary|Percent Change From Baseline in Hepcidin at Day 29|Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect of dapro three times weekly dose regimens on hepcidin. Day 1 values were considered as Baseline values. The Percent change from Baseline at Day 29 post-Baseline time point was calculated and expressed as geometric mean and the maximum change from Baseline was determined.|Baseline and Day 29|ITT Population|||Micrograms per liter (µg/L)||95% Confidence Interval|Geometric Mean
2558770|NCT02689206|Secondary|Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)|Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect of dapro three times weekly dose regimens on VEGF. Day 1 values were considered as Baseline values. The percent change from Baseline at each given post-Baseline time point was calculated (expressed as geometric mean) and the maximum percent change from Baseline was determined.|Baseline and up to Day 29|ITT Population|||Nanograms per liter (ng/L)||95% Confidence Interval|Geometric Mean
2558771|NCT02689206|Secondary|Maximum Observed Change From Baseline in Plasma Erythropoietin (EPO)|Blood samples were collected at Day 1, Day 15 and Day 29 for pharmacodynamic analysis of effect of dapro three times weekly dose regimens on EPO. Day 1 values were considered as Baseline values. Change from Baseline was calculated by subtracting post-Baseline visit values minus Baseline value. The change from Baseline at each given post-Baseline time point was calculated and the maximum change from Baseline was determined.|Baseline and up to Day 29|ITT Population|||International unit per liter (IU/L)||Standard Deviation|Mean
2558772|NCT02689206|Primary|Change From Baseline in Hgb Levels at Day 29|Blood samples were collected from participants for measurement of Hgb values. Baseline is the average of Hgb measured at Week -2 and Day 1 visits. Change from Baseline at Day 29 was defined as post dose value at Day 29 minus Baseline value. The analysis was performed on intent-to-treat (ITT) Population which comprised of all randomized participants who received at least one dose of study treatment, had a Baseline and at least one corresponding on treatment assessment, including Hgb.|Baseline and Day 29|ITT Population|||g/dL||Standard Deviation|Mean
2558773|NCT02689154|Secondary|Number of Participants Able to Reduce Daily Meal Portion Size Utilizing Wireless Food Scale.|Success in these areas will be determined by data collected from within the application's database. Participants will weight meals daily and the app will assist the participant in decrease the quantity of food consumed each day until they achieve age appropriate portion size.|1 month||||Participants|||Count of Participants
2558774|NCT02689154|Secondary|Number of Participants Able to Eliminated Day Time Snacking|Success in these areas will be determined by data collected from within the application's database.|3 months||||Participants|||Count of Participants
2558775|NCT02689154|Secondary|Number of Participants With Success in Withdrawing From Problem Foods|The number of participants who were able to withdraw from 5 or more problem foods was evaluated.|6 months|Withdrawal from Problem Food|||Participants|||Count of Participants
2558776|NCT02689154|Primary|Body Mass Index (BMI) z -Score|The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. A negative change value reflects a decrease in BMI or a better outcome and a positive change value reflects an increase in BMI or a worsening in the outcome.|Baseline and 6 months|18 youth that completed the app intervention|||z-score||Standard Deviation|Mean
2558777|NCT02688933|Post-Hoc|Change From Baseline in Time (Min) of Mean Glucose Concentration Within the Target Range of 70 to 180 mg/dL, by End of Study hbA1c Levels During Week 15 and/or Week 16|Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessments. Data was reported for participants with an end of study HbA1c <7.5 or HbA1c >=7.5% over a 24 hour period.|Baseline, during Week 15 and/or Week 16|mITT population. Here, “number analyzed” signifies the number of participants evaluable for each specified category.|||minutes||Standard Error|Least Squares Mean
2558778|NCT02688933|Other Pre-specified|Change From Baseline in Daily Insulin Dose at Week 16|Change from Baseline at Week 16 for daily basal insulin dose and daily bolus insulin dose was reported.|Baseline, Week 16|Safety population: all participants who took at least 1 dose of randomized treatment & analyzed as-treated (as per treatment actually received) also to whom it was unclear whether they took study medication & who received more than 1 study treatment during trial. Here, “number analyzed”: number of participants evaluable for each specified category.|||International Units||Standard Deviation|Mean
2558779|NCT02688933|Secondary|Coefficient of Variation (CV%) in Mean CGM Glucose|CV% was a measure of spread of variability relative to mean of population. For CGM glucose values over 24 hours, CV% was measure of glycemic variability across 24-hour day and calculated for each period (total, within day and between days) as ratio of standard deviation of glucose values to mean of glucose values.|During Week 15 and/or Week 16|mITT population.|||percent of mean glucose level||Standard Error|Least Squares Mean
2558802|NCT02688842|Secondary|Participants With Target Lesion Failure|a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)|2 years after stent implantation||||Participants|||Count of Participants
2558780|NCT02688933|Secondary|Percentage of Time Glucose Concentrations Within the Target Range of 70 to 140 mg/dL During Last 4 Hours of CGM Data Collection Prior to Next Day Basal Insulin Injection|Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessment during the last 4 hours prior to the next day's basal insulin injection during Week 15 (and/or Week 16).|During Week 15 and/or Week 16|mITT population|||percentage of time||Standard Error|Least Squares Mean
2558781|NCT02688933|Secondary|Mean Change From Baseline in Glucose Level During Last 4 Hours of CGM Data Collection Prior to the Next Day Basal Insulin Injection During Week 15 and/or Week 16|Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessment during the last 4 hours prior to the next day's basal insulin injection during Week 15 (and/or Week 16).|Baseline, during Week 15 and/or Week 16|mITT population.|||mg/dL||Standard Error|Least Squares Mean
2558782|NCT02688933|Secondary|Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year|Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG <=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia eCRF.|Baseline up to Week 16|mITT population.|||events per participant-year|||Number
2558783|NCT02688933|Secondary|Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia|Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG <=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia electronic case report form (eCRF).|Baseline up to Week 16|mITT population.|||percentage of participants|||Number
2558784|NCT02688933|Primary|Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM|The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained from a generalized linear model with identity link including post baseline CGM assessment during Week 15 (and/or Week 16).|During Week 15 and/or 16|Modified intent-to-treat (mITT) population that included all participants who were randomized and had a post-baseline CGM assessment and enough CGM data values to calculate the primary outcome measure, percent of time in range of 70-180 mg/dL during Week 15 (and/or Week 16).|||percentage of time||Standard Error|Least Squares Mean
2558785|NCT02688868|Secondary|Number of Participants With MACE|a composite endpoint of all cause death, any myocardial infarction and any revascularization|4 years|One missed participant in 3 years follow up|||Participants|||Count of Participants
2558786|NCT02688868|Secondary|Number of Participants With MACE|a composite endpoint of all cause death, any myocardial infarction and any revascularization|3 years|One missed participant in 3 years follow up|||Participants|||Count of Participants
2558787|NCT02688868|Secondary|Number of Participants With MACE|a composite endpoint of all cause death, any myocardial infarction and any revascularization|2 years||||Participants|||Count of Participants
2558788|NCT02688868|Secondary|Number of Participants With MACE|a composite endpoint of all cause death, any myocardial infarction and any revascularization|12 months||||Participants|||Count of Participants
2558789|NCT02688868|Secondary|Number of Participants With Target Lesion Failure|including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization|4 years|Two missed participant in 4 years follow up|||Participants|||Count of Participants
2558790|NCT02688868|Secondary|Number of Participants With Target Lesion Failure|including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization|3 years|One missed participant in 3 years follow up|||Participants|||Count of Participants
2558791|NCT02688868|Secondary|Number of Participants With Target Lesion Failure|including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization|2 years||||Participants|||Count of Participants
2558792|NCT02688868|Secondary|Number of Participants With Target Lesion Failure|including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization|12 months||||Participants|||Count of Participants
2558793|NCT02688868|Primary|In-stent Late Loss|the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure.|9 month after stent implantation||||mm||Standard Deviation|Mean
2558794|NCT02688842|Secondary|Major Adverse Cardiac Events|composite endpoint of all cause death, any myocardial infarction and any revascularization|4 years after stent implantation|One participant was lost during 4 years follow up.|||Participants|||Count of Participants
2558795|NCT02688842|Secondary|Major Adverse Cardiac Events|composite endpoint of all cause death, any myocardial infarction and any revascularization|3 years after stent implantation|One participant was lost during 3 years follow up.|||Participants|||Count of Participants
2558796|NCT02688842|Secondary|Major Adverse Cardiac Events|composite endpoint of all cause death, any myocardial infarction and any revascularization|2 years after stent implantation||||Participants|||Count of Participants
2558797|NCT02688842|Secondary|Major Adverse Cardiac Events|composite endpoint of all cause death, any myocardial infarction and any revascularization|12 months after stent implantation||||Participants|||Count of Participants
2558798|NCT02688842|Secondary|Major Adverse Cardiac Events|composite endpoint of all cause death, any myocardial infarction and any revascularization|6 months after stent implantation||||Participants|||Count of Participants
2558799|NCT02688842|Secondary|Major Adverse Cardiac Events|composite endpoint of all cause death, any myocardial infarction and any revascularization|30 days after stent implantation||||Participants|||Count of Participants
2558800|NCT02688842|Secondary|Participants With Target Lesion Failure|a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)|4 years after stent implantation|One participant was lost during 4 years follow up.|||Participants|||Count of Participants
2558801|NCT02688842|Secondary|Participants With Target Lesion Failure|a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)|3 years after stent implantation|One participant was lost during 3 years follow up.|||Participants|||Count of Participants
2561382|NCT02650921|Secondary|Question 11 From Subject Satisfaction Questionnaire|Question 11: The treatment result looks natural|Week 12|ITT|||Participants|||Count of Participants
2558807|NCT02688829|Secondary|Percentage of In-stent Diameter Stenosis|"Percentage of in-stent diameter stenosis is calculated by the following fomula: (RVD‐MLD)/RVD * 100%.~RVD: Reference vessel diameter, represents the averaged diameter of the coronary assumed without atherosclerotic disease.~MLD: Minimal luminal diameter, represents the smallest lumen diameter in the segment of interest."|13 month after stent implantation|Angiographic follow-up at 4 months was obtained in 19 patients.|||percentage of lumen diameter||Standard Deviation|Mean
2558808|NCT02688829|Secondary|Count of Participants With MACE (Major Acute Cardiovascular Events)|Count of Participants who have major acute cardiovascular events (MACE) in 13 months follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization.|13 month after stent implantation||||Participants|||Count of Participants
2558809|NCT02688829|Secondary|In-stent Late Lumen Loss|In-stent late lumen loss (In-stent LLL) is defined as the difference between the post-procedure and 13 months follow-up in-stent minimal lumen diameter.|13 month after stent implantation|Angiographic follow-up at 13months was obtained in 19 patients.|||mm||Standard Deviation|Mean
2558810|NCT02688829|Secondary|Percentage of In-stent Diameter Stenosis|"Percentage of in-stent diameter stenosis is calculated by the following fomula: (RVD‐MLD)/RVD * 100%.~RVD: Reference vessel diameter, represents the averaged diameter of the coronary assumed without atherosclerotic disease.~MLD: Minimal luminal diameter, represents the smallest lumen diameter in the segment of interest."|4 months after stent implantation|Angiographic follow-up at 4 months was obtained in 19 patients.|||percentage of lumen diameter||Standard Deviation|Mean
2558811|NCT02688829|Secondary|Count of Participants With MACE (Major Acute Cardiovascular Events)|Count of Participants who have major acute cardiovascular events (MACE) in 4 months follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization.|4 month after stent implantation||||Participants|||Count of Participants
2558812|NCT02688829|Secondary|In-stent Late Lumen Loss|In-stent late lumen loss (In-stent LLL) is defined as the difference between the post-procedure and 4 months follow-up in-stent minimal lumen diameter.|4 months after stent implantation|Angiographic follow-up at 4 months was obtained in 19 patients.|||mm||Standard Deviation|Mean
2558813|NCT02688829|Primary|Count of Participants With MACE (Major Acute Cardiovascular Events)|Count of Participants who have major acute cardiovascular events (MACE) in 1 month follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization.|1 month after stent implantation||||Participants|||Count of Participants
2558814|NCT02688764|Post-Hoc|Change in Serum Phosphorus (SP) Level From Baseline to End of Stage 1 in PA21 Group, by Serum Phosphorus Level at Baseline|The levels of Serum Phosphorus considered at baseline are those above vs within/below Age Related Normal Range|From Baseline to the End of Stage 1 (up to 10 weeks after treatment start date)|Full Analysis Set (FAS) Population: all participants randomised to treatment at Stage 1 who received at least 1 dose of randomised treatment and who had at least 1 post-baseline assessment of the efficacy endpoint (serum phosphorus level), analysed according to treatment randomised.|||mmol/L||Standard Error|Least Squares Mean
2558815|NCT02688764|Post-Hoc|Change in Serum Phosphorus Level From Baseline to End of Stage 1 in PA21 Group, by Age Group||From Baseline to the End of Stage 1 (up to 10 weeks after treatment start date)|Full Analysis Set (FAS) Population: all participants randomised to treatment at Stage 1 who received at least 1 dose of randomised treatment and who had at least 1 post-baseline assessment of the efficacy endpoint (serum phosphorus level), analysed according to treatment randomised.|||mmol/L||Standard Error|Least Squares Mean
2558816|NCT02688764|Secondary|Tartrate-resistant Acid Phosphatase 5b Values at Each Time Point and Change From Baseline||From baseline through study completion, up to 34 weeks after treatment start date|Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.|||U/L||Standard Deviation|Mean
2558817|NCT02688764|Secondary|Osteocalcin-CL Values at Each Time Point and Change From Baseline||From baseline through study completion, up to 34 weeks after treatment start date|Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.|||ug/L||Standard Deviation|Mean
2558818|NCT02688764|Secondary|Fibroblast Growth Factor 23 Values at Each Time Point and Change From Baseline||From baseline through study completion, up to 34 weeks after treatment start date|Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received|||pg/mL||Standard Deviation|Mean
2558819|NCT02688764|Secondary|Type I Collagen C-Telopeptides Values at Each Time Point and Change From Baseline||From baseline through study completion, up to 34 weeks after treatment start date|Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.|||ug/L||Standard Deviation|Mean
2558820|NCT02688764|Secondary|Bone Specific Alkaline Phosphatase Values at Each Time Point and Change From Baseline||From baseline through study completion, up to 34 weeks after treatment start date|Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.|||ug/L||Standard Deviation|Mean
2558821|NCT02688764|Secondary|25-Hydroxy Vitamin D Values at Each Time Point and Change From Baseline||From baseline through study completion, up to 34 weeks after treatment start date|Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.|||nmol/L||Standard Deviation|Mean
2558822|NCT02688764|Secondary|Transferrin Values at Each Time Point and Change From Baseline||From baseline through study completion, up to 34 weeks after treatment start date|Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.|||g/L||Standard Deviation|Mean
2558823|NCT02688764|Secondary|Iron Values at Each Time Point and Change From Baseline||From baseline through study completion, up to 34 weeks after treatment start date|Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.|||umol/L||Standard Deviation|Mean
2558824|NCT02688764|Secondary|Unsaturated Iron Binding Capacity Values at Each Time Point and Change From Baseline||From baseline through study completion, up to 34 weeks after treatment start date|Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.|||umol/L||Standard Deviation|Mean
2558827|NCT02688764|Secondary|Serum Total Corrected Calcium-Phosphorus Product at Each Time Point and Change From Baseline|Summary statistics of Serum total corrected calcium-phosphorus product at each time point and change from baseline, where serum total corrected calcium-phosphorus product correspond to the product of serum total calcium and Phosphorus, expressed in mmol^2/L^2|From baseline through study completion, up to 34 weeks after treatment start date|Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.|||mmol^2/L^2||Standard Deviation|Mean
2558828|NCT02688764|Secondary|Participants With Sustained Hypercalcaemia|Number and percentages of participants with at least 1 episode of sustained hypercalcaemia (defined as total calcium value above the upper safety limit confirmed by repeat sample 1 week later) during the study|through study completion, up to 34 weeks after treatment start date|Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.|||Participants|||Count of Participants
2558829|NCT02688764|Secondary|Serum Total Corrected Calcium at Each Time Point and Change From Baseline||From baseline through study completion, up to 34 weeks after treatment start date|Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.|||mmol/L||Standard Deviation|Mean
2558830|NCT02688764|Secondary|Serum Phosphorus Values at Each Visit||through study completion, up to 34 weeks after treatment start date|Full Analysis Set (FAS) Population: all participants randomised to treatment at Stage 1 who received at least 1 dose of randomised treatment and who had at least 1 post-baseline assessment of the efficacy endpoint (serum phosphorus level), analysed according to treatment randomised.|||mmol/L||Standard Deviation|Mean
2558831|NCT02688764|Secondary|Participants With Serum Phosphorus Levels Within the Age Related Normal Range in Each Stage|"Number and percentages of participants with serum phosphorus levels below, within and above age-dependent normal ranges at baseline, at the end of Stage 1 and at the end of Stage 2.~The age related normal ranges for serum phosphorus levels are:~0 to <1year 1.36 - 2.62 mmol/L~1 year to <6 years 1.03 - 1.97 mmol/L~6 years to <9 years 1.03 - 1.97 mmol/L~9 years to <10 years 1.03 - 1.97 mmol/L~10 years to <15 years 1.00 - 1.94 mmol/L~15 years to ≤18 years 0.71 - 1.65 mmol/L"|through study completion, up to 34 weeks after treatment start date|Full Analysis Set (FAS) Population: all participants randomised to treatment at Stage 1 who received at least 1 dose of randomised treatment and who had at least 1 post-baseline assessment of the efficacy endpoint (serum phosphorus level), analysed according to treatment randomised.|||Participants|||Count of Participants
2558832|NCT02688764|Secondary|Participants With Serum Phosphorus Levels Within the Age-dependent Target Range in Each Stage|"Number and percentages of participants with serum phosphorus levels below, within and above age-dependent target ranges at baseline, at the end of Stage 1 and at the end of Stage 2.~The age target ranges for serum phosphorus levels are:~0 to <1 year 1.62-2.52 mmol/L~1 year to <6 years 1.45-2.10 mmol/L~6 years to <13 years 1.16-1.87 mmol/L~13 years to ≤18 years 0.74-1.45 mmol/L"|through study completion, up to 34 weeks after treatment start date|Full Analysis Set (FAS) Population: all participants randomised to treatment at Stage 1 who received at least 1 dose of randomised treatment and who had at least 1 post-baseline assessment of the efficacy endpoint (serum phosphorus level), analysed according to treatment randomised.|||Participants|||Count of Participants
2558833|NCT02688764|Secondary|Change in Serum Phosphorus Level From Baseline to the End of Stage 2 in Both Groups||From baseline to study completion, up to 34 weeks after treatment start date|Full Analysis Set (FAS) Population: all participants randomised to treatment at Stage 1 who received at least 1 dose of randomised treatment and who had at least 1 post-baseline assessment of the efficacy endpoint (serum phosphorus level), analysed according to treatment randomised.|||mmol/L||Standard Error|Least Squares Mean
2558834|NCT02688764|Secondary|Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the Phoslyra Group||From Baseline to the End of Stage 1 (up to 10 weeks after treatment start date)|Full Analysis Set (FAS) Population: all participants randomised to treatment at Stage 1 who received at least 1 dose of randomised treatment and who had at least 1 post-baseline assessment of the efficacy endpoint (serum phosphorus level), analysed according to treatment randomised.|||mmol/L||Standard Error|Least Squares Mean
2558835|NCT02688764|Primary|Number and Percentage of Participants With Any Treatment Emergent Adverse Event|"Please note that in this section we are presenting just the overview of the adverse events experienced by the trial participants, in particular, the number of participants with at least one TEAEs until end of stage 2.~Please refer to the detailed tables included on the Adverse Event Module for specifics."|through study completion, up to 34 weeks after treatment start date|Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.|||Participants|||Count of Participants
2558836|NCT02688764|Primary|Number and Percentage of Participants Who Withdrew Due to Treatment Emergent Adverse Events|Any adverse event Leading to Study Drug Withdrawal is considered.|through study completion, up to 34 weeks after treatment start date|Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.|||Participants|||Count of Participants
2558837|NCT02688764|Primary|Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the PA21 Group||From Baseline to the End of Stage 1 (up to 10 weeks after treatment start date)|Full Analysis Set (FAS) Population: all participants randomised to treatment at Stage 1 who received at least 1 dose of randomised treatment and who had at least 1 post-baseline assessment of the efficacy endpoint (serum phosphorus level), analysed according to treatment randomised.|||mmol/L||Standard Error|Least Squares Mean
2558838|NCT02688556|Secondary|Symptom Score|"change from baseline in modified Symptom Assessment in Dry Eye (SANDE) score at 12 weeks.~A modified SANDE instrument was used to evaluate dry eye symptoms at each visit.~Subjects were asked to indicate:~frequency of dry and irritated eyes on a scale of 0 (rarely) to 100 (all the time); and~severity of dry eyes on a scale of 0 (very mild) to 100 (severe) The global symptom score is the square root of the frequency score times the severity score and will be completed at each visit. (range 0 to 100)~Negative change from baseline indicates improvement."|Baseline and 12 weeks|Intent to treat population|||score on a scale||Standard Deviation|Mean
2558869|NCT02688387|Secondary|Change From Baseline in Vital- SBP and DBP, Part 3A|Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP, DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.|Baseline and Up to Day 3|Safety Population|||Milliliters of Mercury||Standard Deviation|Mean
2558839|NCT02688556|Secondary|Central Corneal Staining|"change from baseline in central corneal staining score (fluorescein, modified NEI/FDA scale) at 12 weeks.~The Expanded National Eye Institute (NEI)/Industry Workshop Scale for Corneal Staining Score was used to grade each of the 5 areas of the cornea on a 0 (No punctate stain in area) to 4 (Severe diffuse (coalescent) macropunctate stain of the area) scale."|Baseline and 12 weeks|Intent to treat population|||score on a scale||Standard Deviation|Mean
2558840|NCT02688556|Secondary|Conjunctival Staining|"change from baseline in total conjunctival staining score (lissamine green, modified National Eye Institute scale) at 12 weeks.~Conjunctival Lissamine Green Staining Grades ranged from 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots)"|Baseline and 12 weeks|Intent to treat population|||score on a scale||Standard Deviation|Mean
2558841|NCT02688556|Primary|Tear Production|Percentage of Eyes with Increase from Baseline of ≥ 10 mm in Schirmer's Test Score|Baseline and 12 weeks|Intent to treat population|||Percentage of eyes|||Number
2558842|NCT02688387|Secondary|Number of Participants With SAEs and AEs-Part 3B|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis.|Up to 44 days|Safety Population|||Participants|||Number
2558843|NCT02688387|Secondary|Number of Participants With SAEs and AEs-Part 3A|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis.|Up to 44 days|Safety Population|||Participants|||Number
2558844|NCT02688387|Secondary|Number of Participants With SAEs and AEs-Part 2|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis.|Up to 35 days|Safety Population|||Participants|||Number
2558845|NCT02688387|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)-Part 1|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Safety population was used for analysis.|Up to 42 days|Safety Population.|||Participants|||Number
2558846|NCT02688387|Secondary|Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3B|Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis.|Up to Day 2|Safety Population.|||Participants|||Number
2558847|NCT02688387|Secondary|Number of Participants With Urinalysis Results by Dipstick Analysis-Part 3A|Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis.|Up to Day 2|Safety Population|||Participants|||Number
2558848|NCT02688387|Secondary|Number of Participants With Urinalysis Results by Dipstick Analysis-Part 2|Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis|Up to Day 2|Safety Population|||Participants|||Number
2558849|NCT02688387|Secondary|Number of Participants With Abnormal Urinalysis Results by Dipstick Method-Part 1|Urine samples were collected at Day -1 (Baseline) and 48 hour, from the participants for urinalysis, by standard dipstick method. The parameters analyzed were ketones, glucose, occult blood, and protein. The number of participants with parameters detected as trace-lysed, trace-intact, trace, 2+ and 1+ was reported. Safety Population was used for analysis.|Up to Day 2|Safety Population.|||Participants|||Number
2558850|NCT02688387|Secondary|Number of Participants With Clinical Chemistry Values of PCI- Part 3B|Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. It was collected at Day 2 (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.|Day 2|Safety Population|||Participants|||Number
2558851|NCT02688387|Secondary|Number of Participants With Clinical Chemistry Values of PCI- Part 3A|Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. It was collected at (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.|Day 2|Safety Population.|||Participants|||Number
2558852|NCT02688387|Secondary|Number of Participants With Clinical Chemistry Values of PCI- Part 2|Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. It was collected at Day 2 (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.|Day 2|Safety Population.|||Participants|||Number
2558853|NCT02688387|Secondary|Number of Participants With Clinical Chemistry Values of PCI- Part1|Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of clinical chemistry parameters like glucose, calcium, albumin, sodium and potassium. The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.|Day 2|Safety Population|||Participants|||Number
2558854|NCT02688387|Secondary|Number of Participants With Hematology Values of PCI - Part 3B|Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. It was conducted at Day 2 (48 hour). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.|Day 2|Safety Population.|||Participants|||Number
2558855|NCT02688387|Secondary|Number of Participants With Hematology Values of PCI - Part 3A|Blood samples of 2 mL, via a cannula for were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. It was conducted at Day 2 (48 hours). The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.|Day 2|Safety Population.|||Participants|||Number
2558856|NCT02688387|Secondary|Number of Participants With Hematology Values of PCI - Part 2|Blood samples were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.|Day 2|Safety Population.|||Participants|||Number
2558857|NCT02688387|Secondary|Number of Participants With Hematology Values of Potential Clinical Importance (PCI)- Part1|Blood samples were collected from the participants for analysis of hematology parameters like hematocrit, hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. The data for number of participants, with low and high values of PCI have been reported. Safety population was used for analysis.|Up to Day 3|Safety Population.|||Participants|||Number
2558858|NCT02688387|Secondary|Number of Participants With Abnormal ECG Findings, -Part 3B|12-lead ECG, were measured in semi-supine position after 5 minutes rest. It was conducted as triplicate at screen and baseline, whereas single measure at other times, unless out of range then triplicates were performed. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis.|Up to Day 3|Safety Population|||Participants|||Number
2558859|NCT02688387|Secondary|Number of Participants With Abnormal ECG Findings, -Part 3A|12-lead ECG, were measured in semi-supine position after 5 minutes rest. It was conducted as triplicate at screen and baseline, whereas single measure at other times, unless out of range then triplicates were performed. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis.|Up to Day 3|Safety Population|||Participants|||Number
2558860|NCT02688387|Secondary|Number of Participants With Abnormal ECG Findings, -Part 2|12-lead ECG, were measured in semi-supine position after 5 minutes rest. It was conducted as triplicate at screen and baseline, whereas single measure at other times, unless out of range then triplicates were performed. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis.|Up to Day 3|Safety Population|||Participants|||Number
2558861|NCT02688387|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings, -Part 1|12-lead ECG, was measured in semi-supine position after 5 minutes rest. The data for worst case post-baseline has been reported. Data values for the participants with abnormal clinically significant values are reported. Safety population was used for analysis.|Up to Day 3|Safety Population|||Participants|||Number
2558862|NCT02688387|Secondary|Change From Baseline in Vital Signs-Respiratory Rate, Part 3-B|Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.|Baseline and Up to Day 3|Safety Population.|||Breaths per minute||Standard Deviation|Mean
2558863|NCT02688387|Secondary|Change From Baseline in Vital- Temperature, Part 3B|Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.|Baseline and Up to Day 3|Safety Population|||Degree Celsius||Standard Deviation|Mean
2558864|NCT02688387|Secondary|Change From Baseline in Vital Signs-Heart Rate, Part 3B|Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for HR. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.|Baseline and Up to Day 3|Safety Population.|||Beats per minute||Standard Deviation|Mean
2558865|NCT02688387|Secondary|Change From Baseline in Vital- SBP and DBP, Part 3B|Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP and DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.|Baseline and Up to Day 3|Safety Population.|||Milliliters of Mercury||Standard Deviation|Mean
2558866|NCT02688387|Secondary|Change From Baseline in Vital Signs-Respiratory Rate, Part 3A|Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.|Baseline and Up to Day 3|Safety Population.|||Breaths per minute||Standard Deviation|Mean
2558867|NCT02688387|Secondary|Change From Baseline in Vital- Temperature, Part 3A|Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.|Baseline and Up to Day 3|Safety Population|||Degree Celsius||Standard Deviation|Mean
2558868|NCT02688387|Secondary|Change From Baseline in Vital Signs-Heart Rate, Part 3A|Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Heart rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.|Baseline and Up to Day 3|Safety Population.|||Beats per minute||Standard Deviation|Mean
2558870|NCT02688387|Secondary|Change From Baseline in Vital Signs-Respiratory Rate, Part 2|Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.|Baseline and Up to Day 3|Safety Population.|||Breaths per minute||Standard Deviation|Mean
2558871|NCT02688387|Secondary|Change From Baseline in Vital- Temperature, Part 2|Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. Safety population included all the participants enrolled into the study who received atleast one dose of investigational product.|Baseline and Up to Day 3|Safety Population|||Degree celsius||Standard Deviation|Mean
2558872|NCT02688387|Secondary|Change From Baseline in Vital Signs-Heart Rate, Part 2|Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Heart rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. Safety population included all the participants enrolled into the study who received atleast one dose of investigational product.|Baseline and Up to Day 3|Safety Population.|||Beats per minute||Standard Deviation|Mean
2558873|NCT02688387|Secondary|Change From Baseline in Vital- SBP and DBP, Part 2|Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP and DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.|Baseline and Up to Day 3|Safety Population|||Milliliters of Mercury||Standard Deviation|Mean
2558874|NCT02688387|Secondary|Change From Baseline in Vital Signs-Respiratory Rate, Part 1|Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Respiratory rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.|Baseline and Up to Day 3|Safety Population.|||Breaths per minute||Standard Deviation|Mean
2558875|NCT02688387|Secondary|Change From Baseline in Vital- Temperature, Part 1|Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for temperature. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.|Baseline and Up to Day 3|Safety Population|||Degree celsius||Standard Deviation|Mean
2558876|NCT02688387|Secondary|Change From Baseline in Vital Signs-Heart Rate, Part 1|Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for Heart rate. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1.|Baseline and Up to Day 3|Safety Population.|||Beats per minute||Standard Deviation|Mean
2558877|NCT02688387|Secondary|Change From Baseline in Vital- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), Part 1|Vital signs were measured in semi-supine position after 5 minutes rest and were assessed for SBP and DBP. Change from Baseline, was defined as value at post-Baseline visit minus the Baseline value. Baseline, was defined as Day 1. Safety population included all the participants enrolled into the study who received atleast one dose of investigational product.|Baseline and Up to Day 3|Safety Population|||Milliliters of Mercury||Standard Deviation|Mean
2558878|NCT02688387|Secondary|Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3B|t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. The serial blood samples were assessed at specified timepoints.|Pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48, and 72 hours postdose|PK parameter Population.|||Hour||Geometric Coefficient of Variation|Geometric Mean
2558879|NCT02688387|Secondary|Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 3A|t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. The serial blood samples were assessed at specified timepoints.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK parameter population|||Hour||Geometric Coefficient of Variation|Geometric Mean
2558880|NCT02688387|Secondary|Plasma t1/2 for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part 2|t1/2 is defined as the time required by the concentration of the drug to reach half of its original value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK parameter Population.|||Hour||Geometric Coefficient of Variation|Geometric Mean
2558881|NCT02688387|Secondary|Plasma Half Life (t1/2) for Ambrisentan and Tadalafil in FDC and Reference Treatment Under Fed and Fasted Condition- Part1|t1/2 is defined as the time required by the concentration of the drug to reach half of its original value.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK parameter Population.|||Hour||Geometric Coefficient of Variation|Geometric Mean
2558882|NCT02688387|Secondary|Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3B|Serial blood samples were collected at the indicated time-points. In Part 3B, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK parameter Population.|||Hour||Full Range|Median
2558883|NCT02688387|Secondary|Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 3A|Serial blood samples were collected at the indicated time-points. In Part 3A, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK parameter Population.|||Hour||Full Range|Median
2558884|NCT02688387|Secondary|Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 2|Serial blood samples were collected at the indicated time-points. In Part 3A, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK parameter population.|||hour||Full Range|Median
2558885|NCT02688387|Secondary|Time Taken to Reach Maximum Concentration (Tmax) for Ambrisentan and Tadalafil in FDC and Reference Treatment - Part 1|Serial blood samples were collected at the indicated time-points. In Part 3A, tmax was determined for ambrisentan and tadalafil when administered in FDC (10mg/40mg) under fed state and fasted state and as reference monotherapies (ambrisentan 10 mg and tadalafil 40 mg). PK parameter population was used to measure the tmax.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK parameter Population.|||Hour||Full Range|Median
2558886|NCT02688387|Primary|AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions- Part 3B|AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK parameter population was used for analysis.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK parameter population|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2558887|NCT02688387|Primary|AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B|AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis, was done under fasting conditions post single dose. PK parameter population was used for analysis.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK Parameter Population.|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2558888|NCT02688387|Primary|Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 20 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 20 mg) Under Fasted Conditions-3B|Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK parameter population was used.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK parameter population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2558889|NCT02688387|Primary|AUC (0-t) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B|AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK parameter population was used for analysis.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK parameter population|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2558890|NCT02688387|Primary|AUC (0-inf) for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B|AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36,48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. PK Parameter Population was used for analysis.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK Parameter Population|||Hour nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2558891|NCT02688387|Primary|Cmax for Ambrisentan and Tadalafil, FDCs (Ambrisentan 5 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 5 mg & Tadalafil 40 mg) Under Fasted Conditions-3B|Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3B, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK Parameter Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2558892|NCT02688387|Primary|AUC (0-t) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A|AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3A, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fed and fasting condition post single dose. PK parameter population was used.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK Parameter Population|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2558893|NCT02688387|Primary|AUC (0-inf) for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-3A|AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3A, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48 and 72 hours post-dose. The analysis, was done under fed and fasting conditions post single dose. PK parameter population was used.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK Parameter Population.|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2558894|NCT02688387|Primary|Cmax for Ambrisentan and Tadalafil, Following Candidate FDC (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fed and Fasted Conditions-Part 3A|Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 3A, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis was done under fed and fasting condition post single dose. PK parameter population was used.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK Parameter Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2558895|NCT02688387|Primary|AUC (0-t) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2|AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples for Part 2, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours. The analysis was done under fasting condition post single dose. PK parameter Population was used for analysis. There is no formal hypotheses tested for Part 2 of the study. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK parameter Population|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2558896|NCT02688387|Primary|AUC (0 - Inf) for FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 2|AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples of 2.7 mL and 2 mL were collected for ambrisentan and tadafil respectively. The plasma samples for Part 2, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours post-dose. The analysis, was done under fasting condition post single dose. PK parameter Populatio was used for analysis. There is no formal hypotheses tested for Part 2 of the study. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK parameter Population|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2558897|NCT02688387|Primary|Cmax of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 2|Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected at the indicated time-points, of Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose. The analysis was done under fasting condition post single dose. There is no formal hypotheses tested for Part 2 of the study. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK parameter Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2558898|NCT02688387|Primary|AUC From Time of Dose to Last Measurable Concentration (AUC [0-t]), in FDC, (Ambrisentan 10 mg + Tadalafil 40 mg) Relative to Reference Monotherapies Tested (Ambrisentan 10 mg & Tadalafil 40 mg), Under Fasting- Part 1|AUC (0-t), was defined as, the AUC measured from the time of dose to the last measurable concentration. Blood samples of 2.7 mL and 2 mL, were collected for ambrisentan and tadafil respectively. The plasma samples at Part 1, were collected at the time-points pre-dose, 0.5 hours, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 36, 48 and 72 hours. The analysis was done under fasting condition post single dose. The PK Parameter Population was used for analysis. There is no formal hypotheses tested for Part 1 of the study.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK Parameter Population|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2558899|NCT02688387|Primary|Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to Infinite (Inf) Time, AUC (0-inf) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1|AUC (0- inf), is defined as area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for ambrisentan and tadafil. Blood samples were collected at the indicated time-points. The analysis was done under fasting condition post single dose. There is no formal hypothesis tested for Part 1 of the study.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK parameter Population|||Hour*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2558900|NCT02688387|Primary|Maximum Observed Concentration (Cmax) of Ambrisentan and Tadalafil in FDC (Ambrisentan 10 mg + Tadalafil 40 mg) and Montherapies (Ambrisentan 10 mg & Tadalafil 40 mg) - Part 1|Cmax is defined as the maximum (or peak) plasma concentration that the drug achieves, after the drug has been administered. Blood samples were collected at the indicated time points for analysis of ambrisentan and tadafil. The analysis was done under fasting condition post single dose. There is no formal hypotheses tested for Part 1 of the study. The analysis was performed on Pharmacokinetic (PK) parameter population, which included all participants who provided PK parameter data.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 18, 24, 36, 48 and 72 hours post-dose|PK parameter Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2558901|NCT02688218|Primary|Mean Change in Sensor Glucose in Subjects With Type 1 Diabetes|The mean change in sensor glucose before and after both exercise periods (aerobic and resistance) during the study visit, obtained from Dexcom G4 sensors in the subjects with type 1 diabetes.|4 hours||||mg/dL||Standard Deviation|Mean
2558915|NCT02688153|Secondary|Subjects With a Cardiac Tamponade Over Time|Number of subjects who experienced a Cardiac Tamponade shown over various time points. Cardiac tamponade is when fluid in the pericardium (the sac around the heart) builds up and results in compression (squeezing) of the heart.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
2558916|NCT02688153|Secondary|Subjects With a Thromboembolism Over Time|Number of subjects who experienced a Thromboembolism shown over various time points. A thromboembolism is an obstruction of a blood vessel by a blood clot that has become dislodged from another site in the circulation.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
2558902|NCT02688192|Secondary|Feasibility - Engagement With the App|Engagement with the app was measured by 1) number of in-app exercises completed; 2) points earned (more active = more points); 3) achievements unlocked; and 4) number of likes and comments posted within the social feed. These are count data. Achievements unlocked has possible range of 0 to 20. Number of in-app exercises completed, points earned, and number of likes and comments posted within the social feed have a possible lower limit of 0 and no upper limit; higher numbers indicate more instances of each. The full range of participant data are: number of in-app exercises completed = 0-44; points earned = 0-1,195; number of achievements unlocked = 1-20; number of likes/comments posted = 0-8.|Duration of the FitSurvivor intervention (12 weeks)|All participants from Arm I and Arm II who started the intervention were included. Those who dropped out prior to starting any sessions (n=7) were excluded from this analysis.|||counts||Standard Deviation|Mean
2558903|NCT02688192|Secondary|Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body)|Lower and upper body muscular strength/endurance were measured via 10-repetition maximum (10-RM) tests following National Strength and Conditioning Association guidelines (leg press machine for lower body and barbell bench press for upper body). Weight was increased until participants executed 10 repetitions in good form for both exercises. Estimates of 1-RM leg and bench press were made using a linear prediction equation. Higher scores indicate greater muscular strength/endurance.|Baseline to post-intervention (3 months)|Only participant with complete data were included.|||lbs||Standard Deviation|Mean
2558904|NCT02688192|Secondary|Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test|Cardiorespiratory fitness was measured via submaximal treadmill testing using a modified Bruce protocol. This standardized graded treadmill test adds two warm-up stages, with the first performed at a 1.7 mph and 0% grade and the second at 1.7 mph and 5% grade. Participants performed the graded exercise test until they reached 85% of their age-predicted maximum heart rate, which was measured using a chest-worn Polar heart rate monitor. Estimated VO2 max was calculated for each participant using the multi-stage model and American College of Sports Medicine metabolic equations.|Baseline to post-intervention (3 months)|Only participants with complete data were included in this analysis.|||ml/kg/min||Standard Deviation|Mean
2558905|NCT02688192|Secondary|Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale|The PedsQL Generic Core Scale is a well-validated measure of HRQOL with physical, emotional, social, and cognitive functioning domains. The PedsQL Generic Core yields two summary scores - Physical Summary and Psychosocial Summary. Scores are transformed on a 0-100 scale, with higher scores indicating better functioning.|Baseline to post-intervention (3 months)|Only participants with complete data were included in this analysis.|||score on a scale||Standard Deviation|Mean
2558906|NCT02688192|Secondary|Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale|Fatigue measured using the PedsQL Multidimensional Fatigue Scale. The PedsQL Multidimensional Fatigue Scale yields three subscales: general, sleep/rest, and cognitive fatigue. Scores are transformed on a 0-100 scale, with higher scores indicating better functioning.|Baseline to post-intervention (3 months)|Only participants with complete data were included in this analysis.|||score on a scale||Standard Deviation|Mean
2558907|NCT02688192|Secondary|Feasibility - Retention|Percentage of participants who compete the 3 month assessment|Baseline to post-intervention (3 months)||||Participants|||Count of Participants
2558908|NCT02688192|Primary|Feasibility of the Technology-enhanced Fitness Program|Feasibility will be evaluated by the number of participants who enroll and complete baseline assessment for the randomized trial. In total, 354 participants were mailed letters; 68 were contacted/screened, of which 56 were eligible and 49 enrolled (88% of those screened eligible, 14% of total potentially eligible pool).|Baseline||||Participants|||Count of Participants
2558909|NCT02688153|Secondary|Health Care Utilization|The average amount of time the subjects spent in the intensive care unit, the intermediate care length of stay, and the average total length of hospital stay after their heart valve replacement procedure.|Day of surgical procedure through discharge from the hospital, an average of 2 weeks|This outcome is reported for subjects where data is available.|||Days||Standard Deviation|Mean
2558910|NCT02688153|Secondary|Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time|The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. Subjects took this questionnaire at baseline, 30 days, 3 Months, 6 Months, 1 Year, and 2 Years.|Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.|The outcome is reported where data is available.|||Units on a scale||Standard Deviation|Mean
2558911|NCT02688153|Secondary|Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time|"The Medical Outcomes Study Short-Form 12 (SF-12) - Physical Component Summary (PCS) and Mental Component Summary (MCS).~The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status.~Subject's Average Score at Baseline and at each follow-up interval until 2 year - SF-12."|Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.|The outcome is reported where data is available.|||Units on a scale||Standard Deviation|Mean
2558912|NCT02688153|Secondary|Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time|The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.|Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.|The outcome is reported where data is available.|||Units on a scale||Standard Deviation|Mean
2558913|NCT02688153|Secondary|Subjects Who Died Intraoperatively|Number of subjects who died during surgery.|Surgery|Number of subjects who died during surgery|||Participants|||Count of Participants
2558914|NCT02688153|Secondary|Subjects With a Cardiac Reoperation for Any Reason Over Time|Number of subjects who experienced a Cardiac reoperation for any reason shown over various time points.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
2561383|NCT02650921|Secondary|Question 10 From Subject Satisfaction Questionnaire|Question 10: The skin on my treated hand appears hydrated|Week 12|ITT|||Participants|||Count of Participants
2558917|NCT02688153|Secondary|Subjects With a Myocardial Infarction Over Time|Number of subjects who experienced a Myocardial Infarction shown over various time points. A Myocardial infarction, commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
2558918|NCT02688153|Secondary|Subjects With a Deep Sternal Would Infection Over Time|Number of subjects who experienced a Deep Sternal Wound Infection shown over various time points.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
2558919|NCT02688153|Secondary|Subjects With Endocarditis Over Time|Number of subjects who experienced Endocarditis shown over various time points. Endocarditis is an infection of the endocardium, which is the inner lining of your heart chambers and heart valves.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
2558920|NCT02688153|Secondary|Subjects With Renal Failure Over Time|Number of subjects who experienced Renal (kidney) Failure shown over various time points.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
2558921|NCT02688153|Secondary|Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time|Number of subjects who experienced a Cerebral Vascular Accident or Permanent Stroke shown over various time points.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
2558922|NCT02688153|Secondary|Subjects Who Experienced Respiratory Failure Over Time|Number of subjects who experienced a Respiratory Failure shown over various time points. Respiratory failure happens when not enough oxygen passes from your lungs to your blood.|30 days, 3 Months , 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
2558923|NCT02688153|Secondary|Subjects Who Experienced Major Bleeding Over Time.|Number of subjects who experienced Major Bleeding shown over various time points.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
2558924|NCT02688153|Secondary|Subjects With a Major Paravalvular Leak (OPC) Over Time|"Number of subjects who experienced a Major Paravalvular Leak (OPC) shown over various time points.~Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.~Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. A major paravalvular leak (OPC)are any events of leak that required surgical intervention or were considered an serious adverse event."|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
2558925|NCT02688153|Secondary|Subjects Who Received a Permanent Pacemaker Over Time.|Number of Subjects who received a Permanent Pacemaker shown over various time points.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
2558926|NCT02688153|Secondary|Subjects Who Required a Thoracic Resternotomy Over Time|Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point|||Participants|||Count of Participants
2558927|NCT02688153|Secondary|Conversion of Edwards INTUITY Surgical Aortic Valve to Control During Surgery.|Subjects randomized to the Edwards INTUITY group that were converted to the control group and received commercially available surgical aortic heart valves during surgery.|Prior to Surgery|Original number of subjects randomized to each arm/group.|||Participants|||Count of Participants
2558928|NCT02688153|Secondary|Amount of Aortic Valvular Regurgitation Over Time.|Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.|30 days, 3 months, 6 months, 1 year, 2 year|The outcome is reported for subjects where data is available.|||Participants|||Count of Participants
2558929|NCT02688153|Secondary|Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.|Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.|30 days, 3 months, 6 months, 1 year, 2 year|The outcome is reported for subjects where data is available.|||centimeters squared/meters squared||Standard Deviation|Mean
2558930|NCT02688153|Secondary|Subject's Effective Orifice Area (EOA) Measurement Over Time.|Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.|30 days, 3 months, 6 months, 1 year, 2 year|The outcome is reported for subjects where data is available.|||centimeters squared||Standard Deviation|Mean
2558931|NCT02688153|Secondary|Subject's Average Peak Gradients (mmHg) Measurements Over Time.|Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.|30 days, 3 months, 6 months, 1 year, 2 year|The outcome is reported for subjects where data is available.|||mmHg||Standard Deviation|Mean
2558932|NCT02688153|Secondary|Subject's Average Mean Gradients (mmHg) Measurements Over Time.|Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.|30 days, 3 Months, 6 Months, 1 Year, 2 Years.|The outcome is reported for subjects where data is available.|||mmHg||Standard Deviation|Mean
2558945|NCT02687919|Primary|Change in 6-minute Walk (6-MW) Distance|"Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (c) physical fatigue as measured by the 6-minute (m) walk (6-MW).~Timed 6-minute walk (6-MW): a submaximal measure of gait velocity and endurance over a distance (m) walked in 6 minutes."|End of Study, 3.5 months; Change from Baseline||||meters||Standard Error|Mean
2558933|NCT02688153|Secondary|Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity.~Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.~Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.~Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.~Symptoms of heart failure or the anginal syndrome may be present even at rest."|Baseline and 2 Years|The outcome is reported for subjects where data is available.|||Participants|||Count of Participants
2558934|NCT02688153|Primary|Average Amount of Time Subject Spent on Cardiopulmonary Bypass|Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.|At time of surgery, an average of 2 hours|The outcome is reported for subjects where data is available.|||Minutes||Full Range|Median
2558935|NCT02688153|Primary|Average Subject Time Spent on Cardiopulmonary Cross Clamp|Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.|At time of surgery, an average of 1.5 hours|The outcome is reported for subjects where data is available.|||Minutes||Full Range|Median
2558936|NCT02687919|Secondary|Quality of Life (VSAQ)|"Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by the Veterans Specific Activity Questionnaire (VSAQ).~Veterans Specific Activity Questionnaire (VSAQ): a self-reported survey instrument that serves as a strong predictor of both measured and predicted exercise capacity. Subjects identify a series of activities that they can complete on a typical day (scaled 1-11 for estimated metabolic equivalents (METs)), higher METs indicate increased exercise capacity."|End of Study, measured at 3.5 months; Change from Baseline||||units on a scale||Standard Error|Mean
2558937|NCT02687919|Secondary|Quality of Life (9-HPT)|"Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by the 9-Hole Peg Test (9-HPT).~9-Hole Peg Test: a brief, standardized, quantitative test of upper extremity function. The patient is seated at a table with a small, shallow container holding nine pegs and a wood or plastic block containing nine empty holes (Rolyan 9-Hole Peg Test Kit - Model A8515). On a start command a stopwatch is started, the patient picks up the nine pegs one at a time as quickly as possible, puts them in the nine holes, and, once they are in the holes, removes them again as quickly as possible one at a time, replacing them into the shallow container. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The score for the 9-HPT is an average of the two trials for each hand."|End of Study, measured at 3.5 months; Change from Baseline||||seconds||Standard Error|Mean
2558938|NCT02687919|Secondary|Quality of Life (C-reactive Protein Blood Serum Measures)|Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by C-reactive protein (hs-CRP) blood serum measures.|End of Study, measured at 3.5 months; Change from Baseline||||mg/L||Standard Error|Mean
2558939|NCT02687919|Secondary|Quality of Life (Homocysteine Blood Serum Measures)|Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by homocysteine (HCY) blood serum measures.|End of Study, measured at 3.5 months; Change from Baseline||||μmol/L||Standard Error|Mean
2558940|NCT02687919|Secondary|Quality of Life (Vitamins B-12 and K Blood Serum Measures)|Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by blood serum measures: vitamin B-12 (cobalamin) and vitamin K.|End of Study, measured at 3.5 months; Change from Baseline||||pg/mL||Standard Error|Mean
2558941|NCT02687919|Secondary|Quality of Life (Vitamin B-9 Blood Serum Measures)|Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by vitamin B-9 (folate) blood serum measures.|End of Study, measured at 3.5 months; Change from Baseline|One baseline sample from usual care was lost.|||ng/mL||Standard Error|Mean
2558942|NCT02687919|Secondary|Quality of Life (Vitamin B-1 Blood Serum Measures)|Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by vitamin B-1 (thiamine) blood serum measures.|End of Study, measured at 3.5 months; Change from Baseline||||units listed||Standard Error|Mean
2558943|NCT02687919|Secondary|Quality of Life (MSQOL-54)|"Test the hypothesis that a modified Paleolithic diet improves general well-being/health and quality of life of RRMS patients, compared to controls, as measured by: Multiple Sclerosis Quality of Life-54 (MSQOL-54) Mental and Physical Health scores.~Multiple Sclerosis Quality of Life-54 (MSQOL-54): a multidimensional health-related quality of life survey that combines both generic and MS-specific items into a single instrument. Higher scores (0-100) indicate improved health."|End of Study, measured at 3.5 months; Change from Baseline||||units on a scale||Standard Error|Mean
2558944|NCT02687919|Primary|Change in (25-FW) 25-ft Walk Time|"Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (d) physical fatigue as measured by the 25-ft walk (25-FW; (s).~Timed 25-Foot Walk (T25-FW): a quantitative test of maximal walking velocity, mobility, dynamic balance and leg function. The subject is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly and as safely, as possible. The time is recorded from the first step across the line and ends when the patient crosses the same foot over the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task."|End of Study, measured at 3.5 months; Change from Baseline||||Seconds||Standard Error|Mean
2558981|NCT02687191|Other Pre-specified|Change From Baseline in Intracerebral Hemorrhage (ICH) Volume at 24 Hours|Change from baseline in intracerebral hemorrhage (ICH) volume was calculated at 24 hours.|Baseline (pre-dose), 24 hours|All participants who received the treatment of PF-05230907.|||centimeter (cm)^3||Standard Deviation|Mean
2558946|NCT02687919|Primary|Change in Paced Auditory Serial Addition Test (PASAT) Score|"Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (b) cognitive fatigue as measured by the Paced Auditory Serial Addition Test (PASAT) score.~The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is presented using audio to ensure standardization in the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The score for the PASAT (0-60) is the total number correct out of 60 possible answers."|End of Study, measured at 3.5 months; Change from Baseline||||units on a scale||Standard Error|Mean
2558947|NCT02687919|Primary|Change in Fatigue Severity Scale (FSS)-9 Score|"Specific Aims: 1) Test the hypothesis that a modified Paleolithic diet reduces effects of fatigue in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS), compared to controls, in: (a) daily life as measured by the Fatigue Severity Scale (FSS) score.~A 9-item sel-report questionnaire related to how fatigue interferes with certain activities and rates its severity, items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score is 9 and maximum score is 63. Higher the score indicates greater fatigue severity."|End of Study, measured at 3.5 months; Change from Baseline||||units on a scale||Standard Error|Mean
2558948|NCT02687542|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths|"An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not need necessarily to have a causal relationship with the treatment or usage.~An SAE was any untoward medical occurrence at any dose that:~Resulted in death;~Was life threatening (immediate risk of death);~Required inpatient hospitalization or prolongation of existing hospitalization;~Resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions);~Resulted in congenital anomaly/birth defect."|Day 1 to follow-up (Week 19 visit)|Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo.|||Participants|||Count of Participants
2558949|NCT02687542|Secondary|Total Physician Withdrawal Checklist (PWC-20) on Days 105 and 119, and Change From Day 105 to Day 119|"The PWC-20 is a physician completed, 20 item reliable and sensitive instrument for the assessment of discontinuation symptoms. The PWC-20 was collected after the completion of study treatment and also at the first visit of follow-up.~The total PWC-20 score was the sum of 20 item scores and ranged from 0 to 60. If more than 5 items were missing, the total PWC-20 score was missing; otherwise, the total PWC-20 score was imputed as follows: sum of the non-missing items * (total number of items) / (number of items non-missing). The higher score indicated more frequent/severe symptoms."|Days 105 and 119|Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified time points.|||units on a scale||Standard Deviation|Mean
2558950|NCT02687542|Secondary|Change From Baseline in Total Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)|"The QUIP-RS was a brief, patient reported outcome measure designed to assess the severity of symptoms of Impulsive-Compulsive Disorders (ICDs) and related behaviors reported to occur in Parkinson's disease.~The QUIP-RS assessed 7 disorders (Gambling, Sex, Buying, Eating, Hobbyism-punding [performing tasks and repeating activities] and Taking medications). If more than 5 items were missing, the total QUIP-RS score was set as missing; otherwise, the total QUIP-RS score was imputed as follows: sum of the non-missing item scores * (total number of items) / (number of items non-missing). The higher score indicated a greater level of the ICD.~The total QUIP-RS score for all ICDs and related disorders combined ranges from 0 to 112."|Baseline (Day 0) and Weeks 5, 10 and 15|Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified time points.|||units on a scale||Standard Deviation|Mean
2558951|NCT02687542|Secondary|Number of Participants With Suicidal Ideation Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) at Post-baseline Visits|"The Columbia Suicide Severity Rating Scale (C-SSRS) was an interview based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS responses were mapped to the C-CASA. There were 3 key endpoints for suicidality data analysis and evaluation:~Suicidal Behavior: A participant was said to have suicidal behavior if the participant had experienced completed suicide / suicide attempt / reparatory acts toward imminent suicidal behavior.~Suicidal Ideation: Any observed suicidal ideation mapped to a single C-CASA category.~Suicidal Behavior or Ideation (participants with new onset suicidality): A participant was considered to have a new onset of suicidality if the participant reported no ideation and no behavior at the baseline assessment and reported any behavior or ideation post-baseline. Data observed at screening was not considered in the definition of worsening."|Days 0 (Baseline), 7, 14, 21, 28, 35, 70, 77, 84, 91, 105 and 119|Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified time points.|||Participants|||Count of Participants
2558952|NCT02687542|Secondary|Number of Participants With Electrocardiogram (ECG) Results Meeting the Criteria for Categorical Summarization|"The average of the triplicate readings of ECG data was collected at each assessment time.~Number of participants with ECG results meeting the criteria for categorical summarization for time from the beginning of the P wave until the beginning of the QRS complex (PR Interval), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS Duration), time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QT Interval) and corrected QT (Fridericia correction) (QTcF Interval) were presented."|Baseline (Day 0) to Week 17|Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified categories.|||Participants|||Count of Participants
2558953|NCT02687542|Secondary|Number of Participants With Vital Sign Results Meeting the Criteria for Categorical Summarization|Vital Signs including blood pressure and pulse rate were measured. Vital signs were collected first while the participant was in the supine position and then in the standing position.|Baseline (Day 0) to Week 17|Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo and had evaluable data at specified categories.|||Participants|||Count of Participants
2560131|NCT02668198|Primary|Positive Recurrent Adenomas Using Narrow Band Imaging Confirmed by Histology|The number of recurrent adenomas diagnosed positive with narrow band imaging confirmed by standard histopathology of biopsy.|approximately 6 to 12 months post endoscopic mucosal resection||||adenomas confirmed positive diagnoses|||Number
2558954|NCT02687542|Secondary|Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality|"The safety laboratory tests including Hematology, Clinical Chemistry and Urinalysis were performed.~Determination if there were any laboratory data abnormalities of potential clinical concern was based on Pfizer Data Standards.~Incidence of laboratory test abnormalities (without regard to baseline abnormality) was summarized within each treatment group."|Baseline (Day 0) to Week 17|Safety Analysis Set included all participants who received at least 1 dose of PF-06649751 or placebo.|||Participants|||Count of Participants
2558955|NCT02687542|Secondary|Change From Baseline in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, IV, and Total Score|Each question of Part I,II or IV with 5 responses was linked to the same clinical terms as Part III.The score was missing if more than 7 items were missing for a time point; otherwise Part I,II or IV score was imputed as sum of non-missing items*(total number of items)/(number of items non-missing).•PartI (Non-Motor Aspects of Experiences of Daily Living) assessed non-motor experiences of daily living using 13questions(Range:0-52).•PartII(Motor Aspects of Experiences of Daily Living) assessed motor experiences of daily living using 13questions(Range:0-52).•PartIV(Motor Complications) assessed motor complications,dyskinesias, and motor fluctuations using historical and objective information with 6questions(Range:0-24).•MDS-UPDRS Total Score:the sum of Parts I,II,III,and IV(Range:0-260).Higher score indicated more severe motor signs of Parkinson's disease.Week15's results were interpreted cautiously given almost half participants were not available for the analysis as compared to Week10|Weeks 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement|Full Analysis Set included all participants randomized who completed at least 1 postdose efficacy measurement(Hauser home diary).|||units on a scale||Standard Deviation|Mean
2558956|NCT02687542|Secondary|Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III|"MDS-UPDRS Part III assessed the motor signs of Parkinson's disease and was administered by the investigator. It was comprised of 33 sub-scores based on 18 items, several with right, left or other body distribution scores. Each question was anchored with 5 responses that were linked to commonly accepted clinical terms: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. If more than 7 of the Part III items were missing, the score for that time point was missing, otherwise MDS-UPDRS Part III score was imputed as sum of the non-missing items*(total number of items)/ (number of items non-missing). The MDS-UPDRS Part III total score range is 0-132. Higher score indicated more severe motor signs of Parkinson's disease.~Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10."|Weeks 1, 2, 3, 4, 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement|Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary).|||units on a scale||Standard Error|Least Squares Mean
2558957|NCT02687542|Secondary|Change From Baseline in Daily ON Time Without Troublesome Dyskinesia|"A paper Hauser diary was utilized to record motor state for half hour intervals. The participants answered the Hauser diary on whether they had been ON without troublesome dyskinesia. A diary day started with the interval 24:00-0:30 through 23:30-24:00 on each chronological day for 3 consecutive days. On the days recording the home diary, participants made an entry every 30 minutes during their normal waking time and upon awakening from time asleep.~The daily ON hours was calculated as the average of the 3 consecutive daily ON hours from the Hauser diary at each visit.~Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10."|Weeks 3, 5, 10 and 15; Baseline was defined as the average daily ON time without Troublesome Dyskinesia (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit Day 0)|Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary).|||Hours||Standard Error|Least Squares Mean
2558958|NCT02687542|Secondary|Change From Baseline in Daily ON Time With Troublesome Dyskinesia|"A paper Hauser diary was utilized to record motor state for half hour intervals. The participants answered the Hauser diary on whether they had been ON with troublesome dyskinesia. A diary day started with the interval 24:00-0:30 through 23:30-24:00 on each chronological day for 3 consecutive days. On the days recording the home diary, participants made an entry every 30 minutes during their normal waking time and upon awakening from time asleep.~The daily ON hours was calculated as the average of the 3 consecutive daily ON hours from the Hauser diary at each visit.~Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10."|Weeks 3, 5, 10 and 15; Baseline was defined as the average daily ON time with Troublesome Dyskinesia (using 3 Hauser patient diary Days) prior to Day -1 (study derived day and equalled to nominal visit Day 0).|Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary).|||Hours||Standard Error|Least Squares Mean
2558959|NCT02687542|Secondary|Change From Baseline in Daily OFF Time|"A paper Hauser diary was utilized to record motor state for half hour intervals. Participants completed the diary by answering whether they had been OFF for 3 consecutive days in the week prior to each visit (except Day 28 visit), including 3 consecutive days during the week prior to Day 0 (Randomization).~The daily OFF time was calculated as the average of the 3 consecutive daily OFF hours from the Hauser diary at each visit.~Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10."|Weeks 3, 5, 10 and 15; Baseline was defined as the average daily OFF time (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit day 0).|Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary).|||Hours||Standard Error|Least Squares Mean
2558982|NCT02687191|Secondary|Number of Participants With Depletion of Coagulation Factor X|Depletion of coagulation factor X was defined as >50% reduction relative to baseline (pre-dose).|Baseline (pre-dose), Day 43, Day 91|"All participants who received the treatment of PF-05230907. Number Analyzed represents the number of participants evaluable for each specified category."|||Participants|||Count of Participants
2558960|NCT02687542|Primary|Change From Baseline in Daily OFF Time at Week 10|"A paper Hauser diary was utilized to record motor state for half-hour intervals. Participants completed the diary by answering whether they had been OFF for 3 consecutive days in the week prior to each visit (except Day 28 visit), including 3 consecutive days during the week prior to Day 0 (Randomization).~The daily OFF time was calculated as the average of the 3 consecutive daily OFF hours from the Hauser diary at each visit."|Week 10; Baseline was defined as the average daily OFF time (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit day 0).|Full Analysis Set consisted of all participants randomized who completed at least 1 post-dose efficacy measurement (Hauser home diary).|||Hours||Standard Error|Least Squares Mean
2558961|NCT02687529|Primary|Number of Participants With Concordant CST001 Assay Results for All Replicates Across Three Testing Sites|To demonstrate the reproducibility of the CST001 assay between 3 external laboratories with 2 operators per site.|1 day (At time of enrollment)||||Participants|||Count of Participants
2558962|NCT02687412|Secondary|Cost of Surgical Therapy|Cost of surgical therapy (RMB)|12 month||||RMB||Standard Deviation|Mean
2558963|NCT02687412|Secondary|PCT Calcitonin Postoperative|value of calcitonin postoperative|12 month||||μg/L||Standard Deviation|Mean
2558964|NCT02687412|Secondary|Number of Participants With Postoperative Thrombosis|Evidence of blood thrombosis of participants after surgery|up to 12 months||||Participants|||Count of Participants
2558965|NCT02687412|Secondary|Number of Participants With Postoperative Haemorrhage|Evidence of blood loss from drains or based on ultrasonography|up to 12 months||||Participants|||Count of Participants
2558966|NCT02687412|Secondary|Number of Participants With Ileus|is a disruption of the normal propulsive ability of the gastrointestinal tract|up to 12 months||||Participants|||Count of Participants
2558967|NCT02687412|Secondary|Number of Participants With Postoperative Nausea and Vomiting (PONV)|it was recognized that nausea and vomiting are common side effects of surgical recovery|up to 12 months||||Participants|||Count of Participants
2558968|NCT02687412|Secondary|Number of Participants With Infection,|infection(wound infection, lung infection, intraperitoneal infection, operation space infection)|up to 12 months||||Participants|||Count of Participants
2558969|NCT02687412|Secondary|Number of Participants With Complications|Count of patients with complications in both groups are assessed during the first 21 days postoperatively. Including infection(wound infection, lung infection, intraperitoneal infection, operation space infection), postoperative nausea and vomiting (PONV) , ileus, postoperative hemorrhage, postoperative thrombosis.|up to 12 months||||Participants|||Count of Participants
2558970|NCT02687412|Secondary|CRP|C-Reactive protein mg/L|up to 12 months||||mg/L||Standard Deviation|Mean
2558971|NCT02687412|Primary|The Total Cost (RMB)|The total cost from hospitalization|12 month||||RMB||Standard Deviation|Mean
2558972|NCT02687412|Primary|Length of Hospitalization Post-operation|days from operation date to discharge date|up to 12 months||||days||Standard Deviation|Mean
2558973|NCT02687217|Secondary|Number of Patients Requiring Additional Treatment|Requirement of antipyretics; increased dose/ duration of antibiotic usage other than standard protocol; need for change to higher antibiotics; requirement of drainage procedures for pus/ wound infections; requirement for additional dressing sessions|14 days||||participants|||Number
2558974|NCT02687217|Secondary|Number of Patients Requiring Additional Investigations|Sonography; Pus culture; blood culture; Total Leucocyte Count.|14 days||||participants|||Number
2558975|NCT02687217|Primary|ASEPSIS Score|"ASEPSIS score- Additional treatment; Serous discharge; Erythema; Purulent exudate; Separation of deep tissues; Isolation of bacteria; and Stay. A daily score of 20 or more considered evidence of infection.~Category of infection:~Total score of 0-10 satisfactory healing; 11-20 disturbance of healing; 21-30 minor wound infection; 31-40 moderate wound infection; > 40 severe wound infection."|14 days||||participants|||Number
2558976|NCT02687191|Other Pre-specified|Health Resource Utilization Surrogate Measures - Maximum Duration|Maximum duration for 4 types of hospital or health care unit: Intensive Care Unit (ICU), general ward, rehabilitation center, and other hospital units. This was an exploratory endpoint to evaluate information for designing future studies, which were no longer planned.|Day 1 up to Day 91|"All participants who received the treatment of PF-05230907. Number Analyzed represents the number of participants evaluable for each specified category."|||days||Full Range|Median
2558977|NCT02687191|Other Pre-specified|Neurological Function as Assessed by the National Institute of Health Stroke Scale (NIHSS)|The National Institute of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The total NIHSS score range is from 0 (normal) to 42 (severe impairment), with higher values indicating greater level of neurological impairment.|Screening, Day 1, Day 2, Day 4, Day 43, and Day 91|"All participants who received the treatment of PF-05230907. Number Analyzed represents the number of participants evaluable for each specified category."|||units on a scale||Standard Deviation|Mean
2558978|NCT02687191|Other Pre-specified|Number of Participants With Anti-Paired Basic Amino Acid Cleaving Enzyme (PACE) Furin Antibody Production|Participants with anti-paired basic amino acid cleaving enzyme (PACE) antibody production were those with positive results. Positive: titer value >=2.00.|Day 1, Day 43|"All treated participants who had at least 1 measurement of post-treatment immunogenicity parameters of interest. Number Analyzed represents the number of participants evaluable for each specified category."|||Participants|||Count of Participants
2558979|NCT02687191|Other Pre-specified|Number of Participants With Anti-Chinese Hamster Ovary (CHO) Protein Antibody Production|Participants with anti-Chinese hamster ovary (CHO) antibody production were those with positive results. Positive: titer value >=2.00.|Day 1, Day 43|"All treated participants who had at least 1 measurement of post-treatment immunogenicity parameters of interest. Number Analyzed represents the number of participants evaluable for each specified category."|||Participants|||Count of Participants
2558980|NCT02687191|Other Pre-specified|PF-05230907 Concentration in Plasma||Day 1 pre-dose, 5 and 45 minutes post-dose|"All treated participants who had at least 1 measurement of PF-05230907 concentration. Number Analyzed represents the number of participants evaluable for each specified category."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2558983|NCT02687191|Secondary|Number of Participants With Neutralizing Antibody (NAb) Production|ADA positive samples were planned to be further characterized for neutralizing antibody (NAb). Participants with NAb production were those with at least 1 positive result from Day 1 through follow-up visit (Day 43 and/or Day 91). As all ADA samples were negative (titer value <1.88), NAb analysis was not conducted.|Day 1 up to follow-up visit (Day 43 and/or Day 91)|All treated participants who had at least 1 measurement of post-treatment immunogenicity parameters of interest.||||||
2558984|NCT02687191|Secondary|Number of Participants With Anti-Drug Antibody (ADA) Production|Participants with anti-drug antibody (ADA) production were those with at least 1 positive result from Day 1 through follow-up visit (Day 43 and/or Day 91). ADA positive: titer value >=1.88.|Day 1 up to follow-up visit (Day 43 and/or Day 91)|All treated participants who had at least 1 measurement of post-treatment immunogenicity parameters of interest.|||Participants|||Count of Participants
2558985|NCT02687191|Secondary|Maximum Changes From Baseline for Prothrombin Fragment 1+2 (PF1+2)|Maximum changes from baseline were calculated for prothrombin fragment 1+2 (PF1+2) after dosing with PF-05230907 through Day 2.|Baseline (pre-dose), Day 2|All treated participants who had at least 1 measurement of pharmacodynamic parameters of interest.|||picomoles per liter (pmol/L)||Standard Deviation|Mean
2558986|NCT02687191|Secondary|Maximum Changes From Baseline for Activated Partial Thromboplastin Time (aPTT)|Maximum changes from baseline were calculated for activated partial thromboplastin time (aPTT) after dosing with PF-05230907 through Day 2.|Baseline (pre-dose), Day 2|All treated participants who had at least 1 measurement of pharmacodynamic parameters of interest.|||seconds (sec)||Standard Deviation|Mean
2558987|NCT02687191|Primary|Number of Participants With Electrocardiogram (ECG) Qualitative Results|"The electrocardiogram (ECG) results over time were compared to baseline and assessed by the investigator as less abnormal, no significant change, or more abnormal."|Baseline (pre-dose), Day 2, Day 4, Day 8/discharge|"All participants who received the treatment of PF-05230907. Number Analyzed represents the number of participants evaluable for each specified category."|||Participants|||Count of Participants
2558988|NCT02687191|Primary|Change From Baseline for Supine Pulse Rate|The use of an automated device for measuring pulse rate was acceptable, although, when done manually, pulse rate was measured in the brachial/radial artery for at least 30 seconds.|Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge|"All participants who received the treatment of PF-05230907. Number Analyzed represents the number of participants evaluable for each specified time point."|||beats per minute (bpm)||Standard Deviation|Mean
2558989|NCT02687191|Primary|Change From Baseline for Supine Systolic and Diastolic Blood Pressure|Supine blood pressure (BP, systolic and diastolic) was measured with the participant's arm supported at the level of the heart and recorded to the nearest milliliters of mercury (mmHg) after 5 minutes of rest whenever possible and as permitted by the participant's medical condition.|Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge|"All participants who received the treatment of PF-05230907. Number Analyzed represents the number of participants evaluable for each specified category."|||milliliters of mercury (mmHg)||Standard Deviation|Mean
2558990|NCT02687191|Primary|Change From Baseline for Supine Respiratory Rate|Respiratory rate was measured after 5 minutes rest in supine position by observing and counting the respirations of the participant for 30 seconds and multiplied by 2. The use of an automated device for measuring respiratory rate was acceptable.|Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge|"All participants who received the treatment of PF-05230907. Number Analyzed represents the number of participants evaluable for each specified time point."|||respiration per minute||Standard Deviation|Mean
2558991|NCT02687191|Primary|Change From Baseline for Body Temperature|Body temperature was measured by oral, tympanic, axillary or temporal method.|Baseline (pre-dose), Day 1 (5 and 45 minutes [min] post-dose), Day 2, Day 3, Day 4, Day 8/discharge|"All participants who received the treatment of PF-05230907. Number Analyzed represents the number of participants evaluable for each specified time point."|||Degree Celsius (°C)||Standard Deviation|Mean
2558992|NCT02687191|Primary|Number of Participants With Changes From Baseline in Physical Examination|Comprehensive and targeted physical examinations included general appearance, HEENT (head, eyes, ears, nose and throat), skin, heart (auscultation), lungs (auscultation), abdomen (palpitation and auscultation), and extremities with attention to swelling, general or localized tenderness, entire leg or calf swelling, edema, and collateral superficial veins. The results of the comprehensive and targeted physical examinations were combined to evaluate the changes from baseline through Day 8 (or discharge) for each site parameter according to the categories: positive change (abnormal to normal); no change (normal to normal or abnormal to abnormal); negative change (normal to abnormal). Parameters with at least 1 participant meeting the positive/negative change from baseline criteria are presented here.|Baseline (pre-dose), Day 2, Day 3, Day 4, Day 8/discharge|All participants who received the treatment of PF-05230907.|||Participants|||Count of Participants
2558993|NCT02687191|Primary|Number of Participants With Treatment-Emergent Laboratory Abnormalities|Laboratory safety parameters included hematology, blood chemistry, prothrombin time/international normalized ratio (PT/INR), fibrinogen, antithrombin III (ATIII), Protein S level, Protein C activity, cardiac troponin I, D-dimer, and urinalysis. The number of participants with laboratory test abnormalities meeting specified criteria without regard to baseline abnormality was assessed. Any abnormalities occurring after the administration of treatment and increasing in severity from baseline value were counted as treatment-emergent.|Day 1 through Day 8 (or discharge) for D-dimer laboratory test and urinalysis; Day 1 through Day 4 for all other laboratory tests|All participants who received the treatment of PF-05230907.|||Participants|||Count of Participants
2558994|NCT02687191|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. For the respective event to count as a treatment-emergent AE, onset or worsening of the event must have occurred following treatment with PF-05230907 and during the interval between Day 1 dosing through Day 8.|Day 1 through day of discharge (Day 8)|All participants who received the treatment of PF-05230907.|||Participants|||Count of Participants
2560132|NCT02668198|Primary|Positive Recurrent Adenomas Using Narrow Band Imaging|The number of positive diagnoses using narrow band optical imaging only.|approximately 6 to 12 months post endoscopic mucosal resection||||adenomas with positive diagnoses|||Number
2558995|NCT02687191|Primary|Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)|A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; or was life threatening (immediate risk of death); or required inpatient hospitalization or prolongation of existing hospitalization; or resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or resulted in congenital anomaly/birth defect. Any such events occurring following the start of treatment or increasing in severity were counted as treatment-emergent.|Day 1 through follow-up visit (Day 43)|All participants who received the treatment of PF-05230907.|||Participants|||Count of Participants
2558996|NCT02687191|Primary|Number of Participants With Treatment-Emergent Thromboembolic and/or Ischemic Events (TIEs)|Thromboembolic and/or ischemic events (TIEs) were defined as any of the following events: disseminated intravascular coagulation (Grade [Gr]>=3); acute coronary syndrome (Gr >=3); cardiac arrest (Gr >=4); myocardial infarction (Gr >=3); Cardiac troponin I increased (Gr 3); ischemia cerebrovascular (Gr >=1 and associated with lesion[s]); portal vein thrombosis (Gr >=2); ischemic stroke (Gr >=1 and associated with lesion[s]); transient ischemic attacks (Gr 2); purpura (Gr >=2); superior vena cava syndrome (Gr >=1); thromboembolic event (Gr >=2); visceral arterial ischemia (Gr >=2); peripheral arterial ischemia (Gr >=3). TIEs were graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the respective event to count as a treatment-emergent TIE, onset or worsening of the event must have occurred following treatment with PF-05230907 and during the interval between Day 1 dosing through Day 8.|Day 1 through day of discharge (Day 8)|All participants who received the treatment of PF-05230907.|||Participants|||Count of Participants
2558997|NCT02687139|Primary|Number of Participants With a Correlation Between Radiotracer Uptake on 18F-DCFPyL PET/CT and Conventional Imaging|This was assessed to Correlate Sites of Radiotracer Uptake on 18F-DCFPyL PET/CT With Conventional Imaging Findings.|12 Months|Only the first 14 participants enrolled in this study were assessed for this outcome and published at the time.|||Participants|||Count of Participants
2558998|NCT02687139|Primary|Number of Participants With 18F-DCFPyL PET/CT Detected Sites of Metastatic Renal Cell Carcinoma (RCC)|This was assessed to compare the sites of disease images of patients with RCC on conventional imaging with the images on the 18F-DCFPyL PET/CT to evaluate the sensitivity of DCFPyL PET/CT scans in detecting sites of disease compared to conventional imaging.|12 Months||||Participants|||Count of Participants
2558999|NCT02687126|Other Pre-specified|Cross Sectional Area of Internal Jugular Vein|Correlation of cross sectional area of internal jugular vein with number of attempts, time taken for successful cannulation and complication rate|up to 1 hour before intervention||||Pearson's correlation Coefficient|||Number
2559000|NCT02687126|Secondary|Number of Patients With Complications|Arterial puncture, Hemothorax, Pneumothorax, Local site hematoma|up to 24 hours after intervention||||Participants|||Count of Participants
2559001|NCT02687126|Secondary|Time to Successful Cannulation|Time from skin prick to blood aspiration via the catheter immediately following the guide-wire removal|up to 1 hour after intervention||||Seconds||Standard Deviation|Mean
2559002|NCT02687126|Primary|Number of Attempts for Successful Central Venous Cannulation|An attempt will be considered when complete withdrawal of the puncturing needle out of skin surface will occur|up to 24 hours after intervention||||Attempts||Standard Deviation|Mean
2559003|NCT02686437|Primary|Penn Shoulder Score (PENN)|The PENN is a outcome measure designed to determine the amount of disability patients are experiencing doing day to day activities. The total score is out of 100, 100 being no disability and 0 being completely disabled.|Assessed at baseline, 1,2,3, and 4 weeks|Population analyzed based off of number of subjects who completed the study, see Overall Study Participant Flow section|||units on a scale||Standard Error|Mean
2559004|NCT02686437|Primary|Numeric Pain Rating Scale (NPRS)|Rate the pain on a scale of 0 to 10, 0 being none and 10 being the worst imaginable pain|Assessed at baseline, 1,2,3, and 4 weeks|Population analyzed based off of the number of subjects who completed the study, see Overall Study Participant Flow section|||units on a scale||Standard Error|Mean
2559005|NCT02686164|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||First dose of study drug (Baseline) up to 28 days after last dose of study drug or until resolution, whichever came first (up to approximately 2.5 years)|Safety analysis set included participants who received at least 1 dose of midazolam or lenvatinib and had at least 1 postdose safety assessment.|||participants|||Number
2559006|NCT02686164|Primary|Cmax: Maximum Observed Plasma Concentration for Midazolam and 1'-Hydroxymidazolam||Cycle 1 Day-3: 0-24 hours; Cycle 1 Day 1: 0-24 hours; Cycle 1 Day 14: 0-24 hours (Duration of each cycle=28 days)|PK analysis set included participants who had sufficient PK data to derive at least 1 PK parameter. Here number analyzed “n” are the participants who were evaluable for this outcome measure for given categories.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2559007|NCT02686164|Primary|AUC(0-24): Area Under the Concentration-time Curve From Time Zero to 24 Hours Postdose for Midazolam and 1'-Hydroxymidazolam||Cycle 1 Day-3: 0-24 hours; Cycle 1 Day 1: 0-24 hours; Cycle 1 Day 14: 0-24 hours (Duration of each cycle=28 days)|Pharmacokinetic (PK) analysis set included participants who had sufficient PK data to derive at least 1 PK parameter. Here number analyzed “n” are the participants who were evaluable for this outcome measure for given categories.|||hour*nanograms per milliliter (h*ng/mL)||Standard Deviation|Mean
2559008|NCT02686138|Secondary|Percentage of Subjects With Overall Abdominal Pain Response for 9 Out of 12 Weeks|An overall abdominal pain responder is defined as a weekly responder for the first 9/12 weeks. The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.|First 12 weeks||||Participants|||Count of Participants
2559009|NCT02686138|Secondary|Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 9 Out of 12 Weeks|"An overall CSBM responder is defined as a weekly responder for the first 9/12 weeks. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline and a minimum of at least 3 CSBMs that same week. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds yes to the following question; Did you feel like you completely emptied your bowels?"|First 12 weeks||||Participants|||Count of Participants
2561384|NCT02650921|Secondary|Question 9 From Subject Satisfaction Questionnaire|Question 9: My treated hand appears at least 10 years younger than my untreated hand|Week 12|ITT|||Participants|||Count of Participants
2559010|NCT02686138|Secondary|Percentage of Subjects With Overall Response for 9 Out of 12 Weeks|"An overall responder is defined as a weekly responder for the first 9/12 weeks where both CSBM and abdominal pain response criteria were met for the week. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline and a minimum of at least 3 CSBMs that same week. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds yes to the following question; Did you feel like you completely emptied your bowels? The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline."|First 12 weeks||||Participants|||Count of Participants
2559011|NCT02686138|Secondary|Percentage of Subjects With Overall Abdominal Pain Response for 13 Out of 26 Weeks|An overall abdominal pain responder is defined as a weekly responder for the first 13/26 weeks. The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.|26 weeks||||Participants|||Count of Participants
2559012|NCT02686138|Secondary|Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 13 Out of 26 Weeks|"An overall CSBM responder is defined as a weekly responder for the first 13/26 weeks. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds yes to the following question; Did you feel like you completely emptied your bowels?"|26 weeks||||Participants|||Count of Participants
2559013|NCT02686138|Secondary|Percentage of Subjects With Overall Response for 13 Out of 26 Weeks|"An overall responder is defined as a weekly responder for the first 13/26 weeks where both CSBM and abdominal pain response criteria were met for the week. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds yes to the following question; Did you feel like you completely emptied your bowels? The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline."|26 weeks||||Participants|||Count of Participants
2559014|NCT02686138|Secondary|Percentage of Subjects With Overall Abdominal Pain Response for 6 Out of 12 Weeks|An overall abdominal pain responder is defined as a weekly responder for the first 6/12 weeks. The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.|First 12 weeks||||Participants|||Count of Participants
2559015|NCT02686138|Secondary|Percentage of Subjects With Overall Complete Spontaneous Bowel Movement (CSBM) Response for 6 Out of 12 Weeks|"An overall CSBM responder is defined as a weekly responder for the first 6/12 weeks. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds yes to the following question; Did you feel like you completely emptied your bowels?"|First 12 weeks||||Participants|||Count of Participants
2559016|NCT02686138|Primary|Percentage of Subjects With Overall Response for 6 Out of 12 Weeks|"An overall responder is defined as a weekly responder for the first 6/12 weeks where both CSBM and abdominal pain response criteria were met for the week. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds yes to the following question; Did you feel like you completely emptied your bowels? The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline."|First 12 weeks||||Participants|||Count of Participants
2559017|NCT02686034|Other Pre-specified|Quality of Life Measured by Headache Impact Test (HIT-6)|"The HIT-6 measures impact of headaches on ability to function at work, at home and in social situations. Subjects answer 6 questions about ability to function and normal daily life and for each question they rate the impact of their headaches as 'never' (6 points) or 'rarely' (9 points) or 'sometimes' (10 points) or 'very often' (11 points) or 'always' (13 points). Minimum score = 36, maximum score = 78.~Higher score is worse and lower score is better quality of life"|End of each study period (each study period was 4 weeks)|Intent to treat|||Score||Standard Deviation|Mean
2559018|NCT02686034|Other Pre-specified|Ease of Use|Ease of use of the study devices - Subjects were asked to rate the ease of use of the device from the following options: Very easy, somewhat easy, difficult, very difficult.|End of Study Periods 2 and 3 (each study period was 4 weeks long)|Intent to treat|||Participants|||Count of Participants
2559019|NCT02686034|Other Pre-specified|Mean Change in Pain Score From Baseline to 120 Minutes|Subjects rated pain at onset of migraine attack (baseline) and at 120 minutes using a 4 point headache pain scale where 0 = no pain, 1 = mild pain, 3 = moderate pain and 4 = severe pain. A lower score indicates less pain. Mean change in pain score from baseline to 120 minutes for all attacks in study period 2|120 minutes, Study Period 2 (each study period was 4 weeks long)|Intent to Treat|||score on a scale||95% Confidence Interval|Mean
2559020|NCT02686034|Other Pre-specified|Subject Satisfaction|Subject satisfaction with the study devices Subjects were asked to rate their satisfaction with the device from the following options: Extremely satisfied, Very satisfied, Satisfied, A little satisfied or Not at all satisfied|End of Study Periods 2 and 3 (each study period was 4 weeks long)|Intent to treat|||Participants|||Count of Participants
2559021|NCT02686034|Other Pre-specified|Bang Blinding Index Scores|"After the first treated attack and at the end of the double blind period (period 2) subjects were asked to guess if they were had received 'gammaCore-S', ''sham' or 'do not know'. Bang blinding index estimated are presented for the gammaCore-S and sham.~Bang Blinding Index shows the success of blinding. The blinding index proposed is scaled to an interval of -1 to 1, 1 being complete lack of blinding, 0 being consistent with perfect blinding and -1 indicating opposite guessing which may be related to unblinding.~A score of one means they guess correctly, -1 incorrectly. If the bang index includes 0 it indicates that the guesses were consistent for the sham and active and the study was appropriately blinded"|Study Period 2 (4 weeks)|Intent to treat|||Bang Blinding Index Score||95% Confidence Interval|Number
2559530|NCT02677779|Secondary|Granulation: Percent of Ulcer Area Covered by Granulation.|Percent change of ulcer area covered by granulation from baseline to immediately after the end of procedure.|Baseline and immediately after procedure|ITT analysis: patients with no detectable bacterial load at baseline were included.|||Percent change from baseline||Inter-Quartile Range|Median
2559022|NCT02686034|Other Pre-specified|Quality of Life Measured by EuroQol-5D-5L (EQ-5D-5L)|"Treatment effect on quality of life: EQ-5D-5L is assessed at end of the run-in period and at the end of each 4-week period for nVNS and sham therapies.~EQ-5D-5L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1 = no problems, 2 = slight problems, 3= moderate problems, 4 = severe problems and 5 = extreme problems. Subjects indicate health state by ticking choosing appropriate statement in each dimension. The 5 dimensions scores are combined into a score, where a lower score indicates less problems.~Scores across all 5 dimensions are averaged resulting in a total theoretical score of 1 to 5 with lower scores indicating less problems"|End of each study period (each study period was 4 weeks)|Intent to treat|||Score||Standard Deviation|Mean
2559023|NCT02686034|Other Pre-specified|Number of Subjects With Consistency of Response|Consistency of response, defined as the number of subjects who achieve no pain or mild pain in 50% or greater of their attacks, in subjects treating at least two attacks, for nVNS and sham therapies for all treated attacks during study Periods 2 and 3 (separately).|Study Periods 2 and 3 (each study period was 4 weeks)|Intent to Treat|||participants|||Number
2559024|NCT02686034|Other Pre-specified|Number of Attacks With Sustained Treatment Response|Number of migraine attacks with sustained treatment response (mild or no pain at 24 and 48 hours post-treatment) for nVNS and sham therapies calculated for all treated attacks during study Periods 2 and 3 (separately).|24 and 48 hours; Study Periods 2 and 3 (each study period was 4 weeks)|Intent to treat Period 2 373/347 attacks treated Period 3 286/309 attacks treated|||Attacks|Attacks||Count of Units
2559025|NCT02686034|Other Pre-specified|Number of Migraine Attacks With Absence of Nausea, Vomiting, Photophobia and Phonophobia|Number of Attacks with Absence of Nausea, Vomiting, Photophobia and Phonophobia at 120 minutes for nVNS and sham therapies calculated for all treated attacks during study Periods 2 and 3 (separately).|Study Periods 2 and 3 (each study period was 4 weeks)|Intent to Treat population Period 2 373/347 attacks treated Period 3 286/309 attacks treated|||Attacks|Attacks||Count of Units
2559026|NCT02686034|Other Pre-specified|Number of Migraine Attacks With Treatment Response no Pain or Mild Pain|"Response to treatment was assessed by the subjects using the 4 point headache scale, where 0 = No pain, 1 = Mild pain, 2 = Moderate pain and 3 = severe pain.~Number of migraine attacks with treatment response 'no pain' or 'mild pain' on the 4-point headache pain scale for the nVNS and sham therapies at 30, 60 and 120 minutes calculated for all treated attacks during study Periods 2 and 3 (separately)"|30, 60, 120 minutes; Study Periods 2 and 3 (each study period was 4 weeks)|Intent to Treat Period 2 373/347 attacks treated Period 3 286/309 attacks treated|||Attacks|Attacks||Count of Units
2559027|NCT02686034|Other Pre-specified|Number of Migraine Attacks With Treatment Response 'No Pain' in Study Period 3|"Response to treatment was assessed by the subjects using the 4 point headache scale, where 0 = No pain, 1 = Mild pain, 2 = Moderate pain and 3 = severe pain.~Number of migraine attacks with treatment response 'no pain' for the nVNS and sham therapies at 30, 60 and 120 minutes calculated for all treated attacks during study Period 3."|30, 60, 120 minutes; Period 3 (each study period was 4 weeks)|Intent to Treat Period 2 373/347 attacks treated Period 3 286/309 attacks treated|||Attacks|Attacks||Count of Units
2559028|NCT02686034|Secondary|Number of Migraine Attacks With Treatment Response 'No Pain' in Study Period 2 All Attacks|"Response to treatment was assessed by the subjects using the 4 point headache scale, where 0 = No pain, 1 = Mild pain, 2 = Moderate pain and 3 = severe pain.~Results show % Treatment response 'No pain' for the nVNS and sham therapies at 30, 60 and 120 minutes calculated for all treated attacks during study Period 2."|30, 60, 120 minutes; Study Period 2 (each study period was 4 weeks)|Intent to Treat|||Attacks|Attacks||Count of Units
2559029|NCT02686034|Secondary|Number of Participants With Treatment Response no Pain or Mild Pain at 24 and 48 Hours.|"Response to treatment was assessed by the subjects using the 4 point headache scale, where 0 = No pain, 1 = Mild pain, 2 = Moderate pain and 3 = severe pain.~Results show count of participants with a response of no pain or mild pain on the 4-point headache pain scale at 24, and 48 hours post-treatment (and no rescue medication use) for nVNS and sham therapies for the first treated migraine attack during study Period 2."|24 and 48 hours post-treatment|Intent to Treat|||Participants|||Count of Participants
2559030|NCT02686034|Secondary|Number of Participants With Treatment Response - No Pain or Mild Pain|"Response to treatment was assessed by the subjects using the 4 point headache scale, where 0 = No pain, 1 = Mild pain, 2 = Moderate pain and 3 = severe pain.~Results show count of participants with a response of no pain (score = 0) or mild pain (score = 1) on the 4-point headache pain scale for the nVNS and sham therapies at 2 hours post-treatment and no rescue medication use by 2 hours post-treatment for the first treated migraine attack during study Period 2."|2 hours post-treatment|Intent to Treat|||Participants|||Count of Participants
2559031|NCT02686034|Secondary|Number of Participants With Absence of Nausea/Vomiting, Photophobia, Phonophobia|Presence or absence of nausea/vomiting, photophobia and phonophobia for nVNS and sham therapies for the first treated migraine attack at 120 minutes during study Period 2.|2 hours post-treatment study - period 2 (each study period was 4 weeks)|Intent to treat population|||Participants|||Count of Participants
2559032|NCT02686034|Primary|Number of Participants With Treatment Response - No Pain|The primary objective is to compare the treatment response for nVNS and Sham therapies at two hours post-treatment, for the first treated migraine attack during study Period 2. Treatment response is defined as no pain at 2 hours post-treatment and no rescue medication use by 2 hours post-treatment.|2 hours post-treatment|Sensitivity analysis, Intent to Treat population|||Participants|||Count of Participants
2559033|NCT02685826|Secondary|Participants Who Died Up To Data Cut-off Date (15 December 2017)|This outcome was originally defined as a Kaplan-Meier estimate of overall survival (OS) and was defined as the time between first date of dosing of study medication and death due to any cause. However due to the early study termination and limited follow-up time, the majority of participants were censored for OS analysis. Data reported instead represent the number of participants who died due to any cause from Day 1 up to data cut-off.|Day 1 up to Week 87|Safety population|||Participants|||Count of Participants
2559069|NCT02685293|Secondary|Change From Baseline in Left Atrial Ejection Fraction (LAEF) at 2-3 Hours Post-dose on Day 8|Assessment of LAEF was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.|Baseline and Day 8 of either treatment period 1 or 2, as applicable.|Due to early termination of the study, data for this endpoint were not collected.||||||
2559034|NCT02685826|Secondary|Participants Who Had Either Disease Progression or Death|This outcome was originally defined as a Kaplan-Meier estimate of progression-free survival (PFS) which estimated the time between first date of dosing of study medication and disease progression, as determined by the investigator using the IMWG Uniform Response Criteria, or death during study treatment, whichever occurred earlier. However due to the early study termination and limited follow-up time, the majority of participants were censored for PFS analysis. Data reported instead represent the number of participants who died during study treatment or had disease progression within 90 days of the last dose of durvalumab.|Day 1 up to Week 84|Safety population|||Participants|||Count of Participants
2559035|NCT02685826|Secondary|Participants Who Developed Anti-drug Antibody Against Durvalumab|The number of participants who develop antidrug antibody against durvalumab at any of the sampling timepoints during the study.|Pre-dose samples on Day 1 of cycles 1, 2, 4, 6, 10, and 14 (study days 1, 29, 85, 141, 253, 393)|The Safety Population was defined as all enrolled participants who receive at least 1 dose of the study medications.|||Participants|||Count of Participants
2559036|NCT02685826|Secondary|Lenalidoide (LEN) Plasma Pharmacokinetic (PK) Parameters in Cycle 1 Day 15: Time to Maximum Observed Concentration (Tmax)||Cycle 1 Day 15: pre-dose, 0.5, 1, 2, 4, and 8 hours post LEN dose|The PK Population included participants who received >=1 dose of study treatment and had >=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.|||hour||Full Range|Median
2559037|NCT02685826|Secondary|Lenalidoide (LEN) Plasma Pharmacokinetic (PK) Parameters in Cycle 1 Day 15: Maximum Observed Concentration (Cmax)|Geometric mean was obtained by computing the arithmetic mean of the logarithm-transformed values of concentration/PK parameters and then using the exponentiation to return the computation to the original scales. Geometric CV% was calculated as follows: CV% = 100*SQRT(EXP(σ2)-1), where σ2 denotes the variance of the log-transformed values.|Cycle 1 Day 15: pre-dose, 0.5, 1, 2, 4, and 8 hours post LEN dose|The PK Population included participants who received >=1 dose of study treatment and had >=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2559038|NCT02685826|Secondary|Lenalidomide Plasma PK Parameters in Cycle 1 Day 15: Area Under the Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-last)|Geometric mean was obtained by computing the arithmetic mean of the logarithm-transformed values of concentration/PK parameters and then using the exponentiation to return the computation to the original scales. Geometric CV% was calculated as follows: CV% = 100*SQRT(EXP(σ2)-1), where σ2 denotes the variance of the log-transformed values.|Cycle 1 Day 15: pre-dose, 0.5, 1, 2, 4, and 8 hours post LEN dose|The PK Population included participants who received >=1 dose of study treatment and had >=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2559039|NCT02685826|Secondary|Lenalidoide (LEN) Plasma Pharmacokinetic (PK) Parameters in Cycle 1 Day 1: Apparent Volume of Distribution (Vz/F)|Geometric mean was obtained by computing the arithmetic mean of the logarithm-transformed values of concentration/PK parameters and then using the exponentiation to return the computation to the original scales. Geometric CV% was calculated as follows: CV% = 100*SQRT(EXP(σ2)-1), where σ2 denotes the variance of the log-transformed values.|Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 4, and 8 hours post LEN dose|The PK Population included participants who received >=1 dose of study treatment and had >=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.|||liters||Geometric Coefficient of Variation|Geometric Mean
2559040|NCT02685826|Secondary|Lenalidoide (LEN) Plasma Pharmacokinetic (PK) Parameters in Cycle 1 Day 1: Apparent Clearance (CL/F)|Geometric mean was obtained by computing the arithmetic mean of the logarithm-transformed values of concentration/PK parameters and then using the exponentiation to return the computation to the original scales. Geometric CV% was calculated as follows: CV% = 100*SQRT(EXP(σ2)-1), where σ2 denotes the variance of the log-transformed values.|Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 4, and 8 hours post LEN dose|The PK Population included participants who received >=1 dose of study treatment and had >=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.|||L/hour||Geometric Coefficient of Variation|Geometric Mean
2559041|NCT02685826|Secondary|Lenalidoide (LEN) Plasma Pharmacokinetic (PK) Parameters in Cycle 1 Day 1: Terminal Elimination Half-life (t1/2)|Geometric mean was obtained by computing the arithmetic mean of the logarithm-transformed values of concentration/PK parameters and then using the exponentiation to return the computation to the original scales. Geometric CV% was calculated as follows: CV% = 100*SQRT(EXP(σ2)-1), where σ2 denotes the variance of the log-transformed values.|Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 4, and 8 hours post LEN dose|The PK Population included participants who received >=1 dose of study treatment and had >=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.|||hour||Geometric Coefficient of Variation|Geometric Mean
2559042|NCT02685826|Secondary|Lenalidoide (LEN) Plasma Pharmacokinetic (PK) Parameters in Cycle 1 Day 1: Time to Maximum Observed Concentration (Tmax)||Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 4, and 8 hours post LEN dose|The PK Population included participants who received >=1 dose of study treatment and had >=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.|||hour||Full Range|Median
2559068|NCT02685293|Secondary|Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVi) at 2-3 Hours Post-dose on Day 8|Assessment of LV volume was performed using MRI using LV end systolic volume (LVESV), 2-3 hours after dosing on Day 8 of each treatment period. LVESV was normalized to BSA to provide the indexed counterpart (LVESVi). Baseline was defined as the pre-dose value on Day 1 of treatment period 1.|Baseline and Day 8 of either treatment period 1 or 2, as applicable.|All randomized subjects.|||cm^3/m^2||Standard Deviation|Mean
2561385|NCT02650921|Secondary|Question 8 From Subject Satisfaction Questionnaire|Question 8: My treated hand appears at least 5 years younger than my untreated hand|Week 12|ITT|||Participants|||Count of Participants
2559043|NCT02685826|Secondary|Lenalidoide (LEN) Plasma Pharmacokinetic (PK) Parameters in Cycle 1 Day 1: Maximum Observed Concentration (Cmax)|Geometric mean was obtained by computing the arithmetic mean of the logarithm-transformed values of concentration/PK parameters and then using the exponentiation to return the computation to the original scales. Geometric CV% was calculated as follows: CV% = 100*SQRT(EXP(σ2)-1), where σ2 denotes the variance of the log-transformed values.|Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 4, and 8 hours post LEN dose|The PK Population included participants who received >=1 dose of study treatment and had >=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2559044|NCT02685826|Secondary|Lenalidoide (LEN) Plasma Pharmacokinetic (PK) Parameters in Cycle 1 Day 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf)|Geometric mean was obtained by computing the arithmetic mean of the logarithm-transformed values of concentration/PK parameters and then using the exponentiation to return the computation to the original scales. Geometric CV% was calculated as follows: CV% = 100*SQRT(EXP(σ2)-1), where σ2 denotes the variance of the log-transformed values.|Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 4, and 8 hours post LEN dose|The PK Population included participants who received >=1 dose of study treatment and had >=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2559045|NCT02685826|Secondary|Lenalidoide (LEN) Plasma Pharmacokinetic (PK) Parameters in Cycle 1 Day 1: Area Under the Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-last)|Geometric mean was obtained by computing the arithmetic mean of the logarithm-transformed values of concentration/PK parameters and then using the exponentiation to return the computation to the original scales. Geometric CV% was calculated as follows: CV% = 100*SQRT(EXP(σ2)-1), where σ2 denotes the variance of the log-transformed values.|Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 4, and 8 hours post LEN dose|The PK Population included participants who received >=1 dose of study treatment and had >=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2559046|NCT02685826|Secondary|Durvalumab (DURVA) Serum PK Parameters in Cycle 1: Volume of Distribution (Vz)|Geometric mean was obtained by computing the arithmetic mean of the logarithm-transformed values of concentration/PK parameters and then using the exponentiation to return the computation to the original scales. Geometric CV% was calculated as follows: CV% = 100*SQRT(EXP(σ2)-1), where σ2 denotes the variance of the log-transformed values.|pre-infusion (-60 to -5 minutes prior to dose), end of infusion (EOI), 4 hours, 168 hours (Day 8), 336 hours (Day 15) and 504 hours (Day 22) after administration of DURVA on Day 1|The PK Population included participants who received >=1 dose of study treatment and had >=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.|||liters||Geometric Coefficient of Variation|Geometric Mean
2559047|NCT02685826|Secondary|Durvalumab (DURVA) Serum PK Parameters in Cycle 1: Clearance (CL)|Geometric mean was obtained by computing the arithmetic mean of the logarithm-transformed values of concentration/PK parameters and then using the exponentiation to return the computation to the original scales. Geometric CV% was calculated as follows: CV% = 100*SQRT(EXP(σ2)-1), where σ2 denotes the variance of the log-transformed values.|pre-infusion (-60 to -5 minutes prior to dose), end of infusion (EOI), 4 hours, 168 hours (Day 8), 336 hours (Day 15) and 504 hours (Day 22) after administration of DURVA on Day 1|The PK Population included participants who received >=1 dose of study treatment and had >=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.|||L/day||Geometric Coefficient of Variation|Geometric Mean
2559048|NCT02685826|Secondary|Durvalumab (DURVA) Serum PK Parameters in Cycle 1: Terminal Elimination Half-life (t1/2)|Geometric mean was obtained by computing the arithmetic mean of the logarithm-transformed values of concentration/PK parameters and then using the exponentiation to return the computation to the original scales. Geometric CV% was calculated as follows: CV% = 100*SQRT(EXP(σ2)-1), where σ2 denotes the variance of the log-transformed values.|pre-infusion (-60 to -5 minutes prior to dose), end of infusion (EOI), 4 hours, 168 hours (Day 8), 336 hours (Day 15) and 504 hours (Day 22) after administration of DURVA on Day 1|The PK Population included participants who received >=1 dose of study treatment and had >=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.|||day||Geometric Coefficient of Variation|Geometric Mean
2559049|NCT02685826|Secondary|Durvalumab (DURVA) Serum PK Parameters in Cycle 1: Time to Maximum Observed Concentration (Tmax)||pre-infusion (-60 to -5 minutes prior to dose), end of infusion (EOI), 4 hours, 168 hours (Day 8), 336 hours (Day 15) and 504 hours (Day 22) after administration of DURVA on Day 1|The PK Population included participants who received >=1 dose of study treatment and had >=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.|||day||Full Range|Median
2559050|NCT02685826|Secondary|Durvalumab (DURVA) Serum PK Parameters in Cycle 1: Maximum Observed Concentration (Cmax)|Geometric mean was obtained by computing the arithmetic mean of the logarithm-transformed values of concentration/PK parameters and then using the exponentiation to return the computation to the original scales. Geometric CV% was calculated as follows: CV% = 100*SQRT(EXP(σ2)-1), where σ2 denotes the variance of the log-transformed values.|pre-infusion (-60 to -5 minutes prior to dose), end of infusion (EOI), 4 hours, 168 hours (Day 8), 336 hours (Day 15) and 504 hours (Day 22) after administration of DURVA on Day 1|The PK Population included participants who received >=1 dose of study treatment and had >=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.|||µg/L||Geometric Coefficient of Variation|Geometric Mean
2559531|NCT02677779|Secondary|Fibrin: Percent of Ulcer Area Covered by Fibrin|Percent change of ulcer area covered by fibrin from baseline to immediately after the end of procedure|Baseline and immediately after the end of procedure||||Percent change from baseline||Inter-Quartile Range|Median
2559051|NCT02685826|Secondary|Durvalumab (DURVA) Serum PK Parameters in Cycle 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf)|Geometric mean was obtained by computing the arithmetic mean of the logarithm-transformed values of concentration/PK parameters and then using the exponentiation to return the computation to the original scales. Geometric CV% was calculated as follows: CV% = 100*SQRT(EXP(σ2)-1), where σ2 denotes the variance of the log-transformed values.|pre-infusion (-60 to -5 minutes prior to dose), end of infusion (EOI), 4 hours, 168 hours (Day 8), 336 hours (Day 15) and 504 hours (Day 22) after administration of DURVA on Day 1|The PK Population included participants who received >=1 dose of study treatment and had >=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.|||day*µg/L||Geometric Coefficient of Variation|Geometric Mean
2559052|NCT02685826|Secondary|Durvalumab (DURVA) Serum Pharmacokinetic (PK) Parameters in Cycle 1: Area Under the Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-last)|Geometric mean was obtained by computing the arithmetic mean of the logarithm-transformed values of concentration/PK parameters and then using the exponentiation to return the computation to the original scales. Geometric CV% was calculated as follows: CV% = 100*SQRT(EXP(σ2)-1), where σ2 denotes the variance of the log-transformed values.|pre-infusion (-60 to -5 minutes prior to dose), end of infusion (EOI), 4 hours, 168 hours (Day 8), 336 hours (Day 15) and 504 hours (Day 22) after administration of DURVA on Day 1|The PK Population included participants who received >=1 dose of study treatment and had >=1 measurable PK assessment. If participants were noncompliant with respect to dosing, had incomplete data, or other circumstances that would affect PK evaluation, inclusion was made on a case-by-case basis.|||day*µg/L||Geometric Coefficient of Variation|Geometric Mean
2559053|NCT02685826|Secondary|Kaplan-Meier Estimates for Duration of Response (for Cohort A and B)|Duration of response (for responders only) was defined as the time from earliest date of documented response (PR or better) to the earliest date of disease progression (DP) as determined by the investigator per IMWG Uniform Response criteria or death during study treatment, whichever occurred first.|Day 1 of each cycle starting with Cycle 2 up to Cycle 17 plus one week for the end of treatment visit (Day 29 up to Week 73)|Efficacy Evaluable Population: Participants in Cohorts A + B who had a response.|||months||80% Confidence Interval|Median
2559054|NCT02685826|Secondary|Time to Response (for Cohorts A and B)|Time to response (for responders only, per IMWG Uniform Response Criteria) is calculated as the time from the first date of dosing of study medication to the first date of documented response (PR or better).|Day 1 of each cycle starting with Cycle 2 up to Cycle 17 plus one week for the end of treatment visit (Day 29 up to Week 73)|Efficacy Evaluable Population: Participants in Cohorts A + B who had a response|||weeks||Full Range|Median
2559055|NCT02685826|Secondary|Response Improvement Rate (RIR) for Cohort C: Percentage of Participants Achieving a Response Improved From Cycle 1 Day 1 as Assessed by the Investigators Using the International Myeloma Working Group (IMWG) Uniform Response Criteria|Response Improvement Rate is defined as the percentage of participants who achieved a response from treatment as compared to the pre-autologous stem cell transplantation [ASCT] diseases measurement used as baseline for response assessment. IMWG response categories could be stable disease (SD), partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR), as long as it represented an improvement compared to prior to transplant.|Baseline (Cycle 1 Day 1); Treatment: Day 1 of each cycle starting with Cycle 2 up to Cycle 15 plus one week for the end of treatment visit (Day 29 up to Week 61)|Efficacy Evaluable Population which consists of all enrolled participants who received at least 1 dose of the study medications and had at least 1 evaluable postbaseline response assessment.|||percentage of participants||80% Confidence Interval|Number
2559056|NCT02685826|Secondary|Overall Response Rate (ORR) for Cohorts A and B: Percentage of Participants Who Achieved a Partial Response or Better According to the International Myeloma Working Group (IMWG) Uniform Response Criteria|Tumor response, including progressive disease, was assessed by the investigators and captured the best assessment of response during the treatment period. ORR was defined as partial response (PR) or better which includes PR, very good partial response (VGPR), complete response (CR), or stringent complete response (sCR). A PR required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours. If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas was also required. sCR required - a negative immunofixation of serum and urine and - disappearance of any soft tissue plasmacytomas and - ≤ 5% plasma cells in bone marrow and normal free light-chain (FLC) ratio and - absence of clonal plasma cells by immunohistochemistry or 2- to 4-color flow cytometry.|Day 1 of each cycle starting with Cycle 2 up to Cycle 17 plus one week for the end of treatment visit (Day 29 up to Week 73)|Efficacy Evaluable Population which consisted of enrolled participants who received at least 1 dose of the study medications and had at least 1 evaluable postbaseline response assessment. See the Response Improvement Rate outcome for an efficacy measure for Cohort C.|||percentage of participants||80% Confidence Interval|Number
2559057|NCT02685826|Secondary|Participants With Treatment Emergent Adverse Events (TEAE)|An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. A TEAE includes AEs between the first dose date of either study drug and 90 days after the last dose of study drug. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03): - Grade 1 = Mild - Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required) - Grade 3 = Severe (limitation in activity; medical intervention required) - Grade 4 = Life-threatening - Grade 5 = Death|Day 1 up to Week 84 (the longer of 90 days after discontinuing treatment with DURVA, or 28 days after the last dose of LEN or dex)|Safety population. The Safety Population is defined as all enrolled subjects who receive at least 1 dose of the study medications.|||Participants|||Count of Participants
2559084|NCT02685072|Secondary|Prolonged Abstinence Post Trial|Abstinence from 2 weeks post quit date to the one month follow up|1-month follow-up after end of treatment|Participants (n=14 in TPN + progesterone; n=9 in TPN + placebo) missing breath CO data were coded as > 10 ppm (positive for smoking).|||Participants|||Count of Participants
2559058|NCT02685826|Primary|Participants With Dose-Limiting Toxicities (DLTs) During the Dose-Determining Timeframe (Day 1 - Day 28)|A Dose Review Team (DRT) evaluated DLTs and, if applicable, other data to determine the recommended dose (RD) of durvalmab to use in the Expansion Period. The DRT included sponsor personnel, investigators and outside consultants. A DLT was defined as: a. Grade 4 neutropenia for >= 5 days. b. Grade 3 neutropenia associated with fever (≥ 38.5°C / 101.3°F) of any duration. c. Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding, or platelets transfusion. d. Grade 4 hematologic toxicity that does not resolve to baseline level <=72 hours. e. Grade 4 anemia, unexplained by underlying disease. f. Any nonhematologic toxicity Grade ≥ 3 except for alopecia and nausea. g. Treatment interruption >= 2 weeks due to AE. If ≤ 1 of the 6 initial participants in each cohort experience a DLT during cycle 1, the RD was durvalumab 1500 mg; If >=2 of the 6 initial participants in any cohort experience a DLT during cycle 1, the maximum tolerated dose (MTD) was exceeded and the|First treatment cycle: Day 1 to Day 28|Dose-Determining Population consists of all participants from the Safety Population of the Dose Determining Period who received at least one dose of durvalumab. Cohort B's Dose-Determining Population was 7 participants as one was considered non-evaluable and was therefore replaced per protocol.|||Participants|||Count of Participants
2559059|NCT02685488|Post-Hoc|State Anxiety Assessed With Two Items From the Visual Analogue Mood Scale|The Visual Analog Mood Scale (VAMS) asks patients to rate how much they are experiencing eight mood categories on a scale of 0-100. Global Affect and Global Vigor are subscales. The Global Vigor scale includes a number of items related to anxiety (calm, tense) as well as fatigue (alert, weary). Based on decreases that were seen in global vigor, we create a sum variable of only calm & tense items on the VAMS to examine whether state anxiety decreased. Scores range from 0-20, with higher scores indicating more anxiety. This sum variable served as a post-hoc measures of anxiety each day of the study before stimulation/sham, 10 minutes after stimulation/sham, and 30 minutes after stimulation/sham. Outcome is the difference between measure taken 10 minutes after Stim/Sham and measure taken before Stim/Sham. This measure was taken each of the five days and outcome represents the average over all five days from after to before Stim/Sham.|Assessed before Stim/Sham and 10 minutes after every day for five days; scores represent change from after to before stim/sham averaged across all five days||||units on a scale||Standard Deviation|Mean
2559060|NCT02685488|Secondary|Anxiety Symptoms Assessed With the Overall Anxiety Severity and Impairment Scale|The Overall Anxiety Severity and Impairment Scale (OASIS) assesses severity of anxiety symptoms across anxiety disorders and with subsyndromal symptoms. Participants rate five items on a scale from 0 (indicating no anxiety or impairment) to 4 (indicating severe or extreme anxiety or impairment). Scores range from 0 to 20, with higher scores indicating more severe anxiety and impairment from anxiety (Norman et al., 2006). The OASIS was used to monitor overall severity of anxiety on each day of the study. The outcome measure is difference from Day 5 to Day 1.|Once on day 1 & day 5||||units on a scale||Standard Deviation|Mean
2559061|NCT02685488|Secondary|Worry Symptoms Assessed With the Penn State Worry Questionnaire|"The PSWQ assesses trait worry, a key component of Generalized Anxiety Disorder. Participants rate themselves on a scale of 1 (not at all typical of me) to 5 (very typical of me) for sixteen different statements. Scores range from 16-80, and higher scores reflect higher levels of worry. This scale has been widely used to assess worry and will allow for assessment of worry in the present study (Brown et al., 1992). The PSWQ was used to monitor symptoms of worry on first and fifth day of this study. The outcome measure is difference from Day 5 to Day 1."|Once on day 1 & day 5||||units on a scale||Standard Deviation|Mean
2559062|NCT02685488|Secondary|Rumination Symptoms Assessed With the Ruminative Responses Scale|"The Ruminative Responses scale (RRS) consists of 22 statements. It measures rumination, past-focused repetitive thinking that causes and maintains depression. Participants are asked to rate on a scale of 1 (almost never) to 4 (almost always) how much they think about various things (e.g. think about how alone you feel and think about all your shortcomings, failings, faults, mistakes). Scores range from 22 to 88 with higher scores indicating more rumination. The RRS was used in this study to measure symptoms of rumination on the first and fifth day of this study. The outcome is the difference from Day 5 to Day 1."|Once on day 1 & 5||||units on a scale||Standard Deviation|Mean
2559063|NCT02685488|Primary|Depressive Symptoms Assessed With the Beck Depression Inventory-II|The Beck Depression Inventory-II (BDI-II) is one of the most widely used self-report measures for assessing depression. It includes 21 self-report items. Scores range from 0 to 63, and higher scores indicate higher levels of depressive symptoms. In this study, the BDI-II was used to monitor depressive symptoms each day. The outcome is the change in BDI-II score as measured by BDI-II on Day 5 minus BDI-II on Day 1.|Once on day 1 & day 5||||units on a scale||Standard Deviation|Mean
2559064|NCT02685436|Primary|Number of Participants in Each Level of Wheeze Control|Number of Participants with controlled Wheezing Number of Participants with partially controlled Wheezing Number of Participants with uncontrolled wheezing|3 months|Abnormal esophageal impedance-pH and or reflux esophagitis|||Participants|||Count of Participants
2559065|NCT02685293|Secondary|Change From Baseline in Pulmonary Artery Pulsatility Index (PAPi) at 2-3 Hours Post-dose on Day 8|Assessment of PAPi was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.|Baseline and Day 8 of either treatment period 1 or 2, as applicable.|All randomized subjects.|||percent||Standard Deviation|Mean
2559066|NCT02685293|Secondary|Change From Baseline in Pulsatility Index Aorta (PIAo) at 2-3 Hours Post-dose on Day 8|Assessment of PIAo was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.|Baseline and Day 8 of either treatment period 1 or 2, as applicable.|All randomized subjects.|||percent||Standard Deviation|Mean
2559067|NCT02685293|Secondary|Change From Baseline in Right Ventricular End Systolic Volume Index (RVESVi) at 2-3 Hours Post-dose on Day 8|Assessment of RV volume was performed using MRI using RV end systolic volume (RVESV), 2-3 hours after dosing on Day 8 of each treatment period. RVESV was normalized to BSA to provide the indexed counterpart (RVESVi). Baseline was defined as the pre-dose value on Day 1 of treatment period 1.|Baseline and Day 8 of either treatment period 1 or 2, as applicable.|All randomized subjects.|||cm^3/m^2||Standard Deviation|Mean
2559532|NCT02677779|Secondary|Pain: Scores of Brief Pain Inventory|Scores of Brief Pain Inventory. Scale ranges: from 0 to 10. 0 = No pain; 10= Pain as bad as you can imagine.|During procedure.|ITT analysis: patients with no detectable bacterial load at baseline were included.|||cm for a VAS scale.||Inter-Quartile Range|Median
2559070|NCT02685293|Secondary|Change From Baseline in Left Atrial End Systolic Volume (LAESV) at 2-3 Hours Post-dose on Day 8|Assessment of LAESV was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.|Baseline and Day 8 of either treatment period 1 or 2, as applicable.|Due to early termination of the study, data for this endpoint were not collected.||||||
2559071|NCT02685293|Secondary|Change From Baseline in Left Atrial End Diastolic Volume (LAEDV) at 2-3 Hours Post-dose on Day 8|Assessment of LAEDV was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.|Baseline and Day 8 of either treatment period 1 or 2, as applicable.|Due to early termination of the study, data for this endpoint were not collected.||||||
2559072|NCT02685293|Secondary|Change From Baseline in Pulmonary Artery/Aortic Diameter Ratio (PA:A) at 2-3 Hours Post-dose on Day 8|Assessment of PA:A was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.|Baseline and Day 8 of either treatment period 1 or 2, as applicable.|All randomized subjects|||ratio||Standard Deviation|Mean
2559073|NCT02685293|Secondary|Change From Baseline in Pulmonary Vascular Resistance (PVR) at 30 and 60 Minutes Post-dose on Day 8|Assessment of PVR was performed by impedance cardiography at 30 and 60 minutes after dosing on Day 8 of each treatment period. Baseline for was defined as the average of the subject values obtained pre-dose on Day 1 of each treatment period.|Baseline and Day 8 of either treatment period 1 or 2, as applicable.|Due to early termination of the study, data for this endpoint were not collected.||||||
2559074|NCT02685293|Secondary|Change From Baseline in Cardiac Output at 2-3 Hours Post-dose on Day 8|Assessment of cardiac output was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.|Baseline and Day 8 of either treatment period 1 or 2, as applicable.|All randomized subjects.|||Liters/minute||Standard Deviation|Mean
2559075|NCT02685293|Secondary|Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi) at 2-3 Hours Post-dose on Day 8|Assessment of left ventricular (LV) volume was performed using MRI using LV end diastolic volume (LVEDV), 2-3 hours after dosing of Day 8 of each treatment period. LVEDV was normalized to BSA to provide the indexed counterpart (LVEDVi). Baseline was defined as the pre-dose value on Day 1 of treatment period 1.|Baseline and Day 8 of either treatment period 1 or 2, as applicable.|All randomized subjects.|||cm^3/m^2||Standard Deviation|Mean
2559076|NCT02685293|Secondary|Change From Baseline in Pulmonary Artery Velocity at 2-3 Hours Post-dose on Day 8|Assessment of Pulmonary Artery Velocity was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.|Baseline and Day 8 of either treatment period 1 or 2, as applicable.|All randomized subjects.|||cm/second||Standard Deviation|Mean
2559077|NCT02685293|Secondary|Change From Baseline in Right Ventricular Stroke Volume (RVSV) at 2-3 Hours Post-dose on Day 8|Assessment of RVSV, phase contrast from pulmonic valve, was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.|Baseline and Day 8 of either treatment period 1 or 2, as applicable.|All randomized subjects.|||cm^3||Standard Deviation|Mean
2559078|NCT02685293|Secondary|Change From Baseline in Aortic Left Ventricular Stroke Volume (LVSV) at 2-3 Hours Post-dose on Day 8|Assessment of LVSV was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.|Baseline and Day 8 of either treatment period 1 or 2, as applicable.|All randomized subjects.|||cm^3||Standard Deviation|Mean
2559079|NCT02685293|Primary|Change From Baseline in Right Ventricular End Diastolic Volume Index (RVEDVi) at 2-3 Hours Post-dose on Day 8|Assessment of right ventricular (RV) volume was performed using magnetic resonance imaging (MRI) using RV end diastolic volume (RVEDV), 2-3 hours after dosing on Day 8 of each treatment period. RVEDV was normalized to body surface area (BSA) to provide the indexed counterpart (RVEDVi). Baseline was defined as the pre-dose value on Day 1 of treatment period 1.|Baseline and Day 8 of either treatment period 1 or 2, as applicable.|All randomized subjects.|||cm^3/m^2||Standard Deviation|Mean
2559080|NCT02685202|Secondary|Change in the Epworth Sleepiness Scale (ESS) Score|Daytime sleepiness will be assessed using the ESS which is based on responses to self-administered questions that assess the propensity of the subject to fall asleep in 8 everyday situations (e.g., sitting and reading, talking to someone, being stopped in traffic). Scores for the ESS range from 0 to 24, with a higher score indicating greater daytime sleepiness.|Baseline, 16 weeks|No participants could be reached to obtain ESS scores; therefore, data for this outcome measure are unavailable.||||||
2559081|NCT02685202|Secondary|Change in the Apnea Hypopnea Index (AHI)|The AHI is the sum of the number of apneas and hypopneas recorded during the home sleep test per hour of recorded sleep. The AHI is used to indicate the severity of obstructive sleep apnea.|Baseline, 16 weeks|No participants could be reached to obtain apnea and hypopneas sums; therefore, data for this outcome measure are unavailable.||||||
2559082|NCT02685202|Primary|Change in the Weekly Mean Pain Index Score|"Weekly mean pain index is computed as the arithmetic mean of daily pain index values recorded at enrollment and then at the end of each week throughout the 16 week observation period.~Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = no pain and 100 = the most intense pain imaginable) multiplied by pain duration (0-100 percentage scale) where percentage refers to the percent of waking day that the participant had facial pain) as reported in the Daily Symptom Diary.~It is computed from the weekly mean pain index (numeric rating scale 0-10), and representing the arithmetic mean of daily pain index values in the preceding 7-day period. The pain index for any given day is the product of the pain intensity score multiplied by the pain duration score, each as reported in the Daily Symptom Diary kept by the subject."|Baseline, 16 weeks|No participants could be reached to obtain pain symptom diary information; therefore, data for this outcome measure are unavailable.||||||
2559083|NCT02685072|Secondary|Prolonged Abstinence Follow up|Abstinence from 2 weeks post quit date to 3 month follow up (total of 6-8 weeks during the trial and 3 month follow up)|3-month follow-up after end of treatment|Participants (n=14 in TPN + progesterone; n=9 in TPN + placebo) missing breath CO data were coded as > 10 ppm (positive for smoking).|||Participants|||Count of Participants
2561386|NCT02650921|Secondary|Question 7 From Subject Satisfaction Questionnaire|Question 7: The veins on my treated hand are less apparent compared to my untreated hand|Week 12|ITT|||Participants|||Count of Participants
2559085|NCT02685072|Secondary|Positive and Negative Affect Schedule (PANAS) Total Score|The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.|3 month follow up||||score on a scale||Standard Deviation|Mean
2559086|NCT02685072|Secondary|Positive and Negative Affect Schedule (PANAS) Total Score|The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.|1 month follow up||||score on a scale||Standard Deviation|Mean
2559087|NCT02685072|Secondary|Positive and Negative Affect Schedule (PANAS) Total Score|The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.|Week 8||||score on a scale||Standard Deviation|Mean
2559088|NCT02685072|Secondary|Positive and Negative Affect Schedule (PANAS) Total Score|The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.|Week 7||||score on a scale||Standard Deviation|Mean
2559089|NCT02685072|Secondary|Positive and Negative Affect Schedule (PANAS) Total Score|The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.|Week 6||||score on a scale||Standard Deviation|Mean
2559090|NCT02685072|Secondary|Positive and Negative Affect Schedule (PANAS) Total Score|The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.|Week 5||||score on a scale||Standard Deviation|Mean
2559091|NCT02685072|Secondary|Positive and Negative Affect Schedule (PANAS) Total Score|The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.|Week 4||||score on a scale||Standard Deviation|Mean
2559092|NCT02685072|Secondary|Positive and Negative Affect Schedule (PANAS) Total Score|The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.|Week 3||||score on a scale||Standard Deviation|Mean
2559093|NCT02685072|Secondary|Positive and Negative Affect Schedule (PANAS) Total Score|The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.|Week 2|Note: numbered analyzed does not equal 24|||score on a scale||Standard Deviation|Mean
2559094|NCT02685072|Secondary|Positive and Negative Affect Schedule (PANAS) Total Score|The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.|Baseline||||score on a scale||Standard Deviation|Mean
2559095|NCT02685072|Secondary|Change in Digit Symbol Task Measure of Inhibitory Function|The Code Substitution Test (a computerized adaptation/variant of the Digit Symbol Substitution Test) is a test of psychomotor performance. The Code Substitution-Learning Throughput Score incorporates both accuracy and speed. During the learning phase of this test, users are continuously shown a row of 9 digits that are paired with a symbol (the pairings are constant). Users are presented with a series of individual pairings and are asked to press a response key to indicate if the pairing is correct or not. Quicker and more accurate responses lead to higher scores. The lowest possible score is 0 (no correct responses). There is no defined maximum score, as the score depends upon both response time and number of correct responses. A change score was calculated by subtracting baseline score from week 2 score. Higher positive scores represent greater improvement in scores at week 2 relative to baseline, and lower negative scores represent greater decline in scores from baseline to week 2.|baseline and week 2|Includes participants who completed the Code Substitution-Learning Test.at both baseline and week 2 visits.|||units on a scale||Standard Deviation|Mean
2559096|NCT02685072|Secondary|Change in Go/No Go Task Measure of Inhibitory Function|"Week 2 minus baseline. This task assesses the ability to withhold responses to an infrequently occurring target (No-Go trials). A total of 225 single digits (25 x 9 digits) are presented on a computer monitor for 250 ms each, immediately followed by a mask for 900 ms. Subjects must press a spacebar in response to every digit except the 3.~Go/No Go score is calculated as separation between the means of the signal and the noise distributions and is reported in standard deviation units, representing an overall indicator of performance since it accounts for correct responses and incorrect responses. Higher scores represent a better outcome. For the change score, higher positive scores represent greater improvement in scores between baseline and week 2, and lower negative scores represent greater decline in scores between baseline and week 2."|baseline and week 2|Includes participants who completed the Go/No Go task at both baseline and week 2 visits.|||units on a scale||Standard Deviation|Mean
2559097|NCT02685072|Secondary|Change in Stroop Measure of Inhibitory Function|The Stroop test assesses cognitive processing. The Level 3 Stroop Throughput score incorporates both accuracy and speed. In Level 3 of the Stroop test, a series of words representing colors are shown in a font color that is incongruent with the word (e.g. RED would be shown in blue font). Users are asked to press a response key associated with the color of the font, not the written word. Quicker and more accurate responses lead to higher scores. The lowest possible score is 0 (no correct responses). There is no defined maximum score, as the score depends upon both response time and number of correct responses. A Level 3 Stroop Throughput change score was calculated by subtracting baseline score from week 2 score. Higher positive scores represent greater improvement in scores at week 2 relative to baseline, and lower negative scores represent greater decline in scores from baseline to week 2.|baseline and week 2|Includes people who completed Stroop Test at both baseline and Week 2 visits.|||units on a scale||Standard Deviation|Mean
2559098|NCT02685072|Secondary|Carbon Monoxide <10 Ppm|Smoking abstinence measured by breath CO|3 month follow up|Participants (n=14 in TPN + progesterone; n=9 in TPN + placebo) missing breath CO data were coded as > 10 ppm (positive for smoking).|||Participants|||Count of Participants
2559099|NCT02685072|Secondary|Carbon Monoxide <10 Ppm|Smoking abstinence measured by breath CO|1 month follow up|Participants (n=14 in TPN + progesterone; n=9 in TPN + placebo) missing breath CO data were coded as > 10 ppm (positive for smoking).|||Participants|||Count of Participants
2559100|NCT02685072|Secondary|Carbon Monoxide <10 Ppm|Smoking abstinence measured by breath CO|end of 8 weeks of treatment|Participants (n=13 in TPN + Progesterone; n=10 in TPN + Placebo) missing breath CO were coded as ≥ 10 ppm (positive for smoking).|||Participants|||Count of Participants
2559101|NCT02685072|Primary|7-day Point Prevalence of Smoking Abstinence|The 7-day point prevalence is defined by self-reported smoking abstinence for the last 7 days.|end of 8 weeks of treatment|Participants (n=13 in TPN + Progesterone; n=9 in TPN + Placebo) missing outcome data were coded as not abstinent.|||Participants|||Count of Participants
2559102|NCT02685033|Secondary|Number of Participants With Clinical Cure by Baseline Pathogen at Day 180 in the CE Population|Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring >6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).|Day 180|CE-D180 population included all mITT participants who met specific conditions for evaluability at Day 180 (D180). Includes participants who had baseline pathogens. Participants who had more than one pathogen at Baseline were counted in each category.|||participants|||Number
2559103|NCT02685033|Secondary|Number of Participants With Clinical Cure by Baseline Pathogen at Day 42 in the CE Population|Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring >6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).|Day 42|CE-D42 population included all mITT participants who met specific conditions for evaluability at Day 42 (D42). Includes participants who had baseline pathogens. Participants who had more than one pathogen at Baseline were counted in each category.|||participants|||Number
2559104|NCT02685033|Primary|Percentage of Participants With Clinical Response at Day 365 in the CE Population|Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring >6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).|Day 365|CE-D365 population included all mITT participants who met specific conditions for evaluability at Day 365 (D365).|||percentage of participants||95% Confidence Interval|Number
2559105|NCT02685033|Secondary|Percentage of Participants With Clinical Response at Day 365 in the mITT Population|Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring >6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).|Day 365|mITT population included all ITT participants who received any amount of randomized medication and met the criteria for known or suspected Gram-positive osteomyelitis. Participants from whom only a Gram-negative pathogen was isolated from blood and/or bone culture were excluded.|||percentage of participants||95% Confidence Interval|Number
2559106|NCT02685033|Secondary|Percentage of Participants With Clinical Response at Day 180 in the CE Population|Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring >6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).|Day 180|CE-D180 population included all mITT participants who met specific conditions for evaluability at Day 180 (D180).|||percentage of participants||95% Confidence Interval|Number
2559107|NCT02685033|Secondary|Percentage of Participant With Clinical Response at Day 180 in the mITT Population|Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring >6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).|Day 180|mITT population included all ITT participants who received any amount of randomized medication and met the criteria for known or suspected Gram-positive osteomyelitis. Participants from whom only a Gram-negative pathogen was isolated from blood and/or bone culture were excluded.|||percentage of participants||95% Confidence Interval|Number
2559108|NCT02685033|Secondary|Percentage of Participants With Clinical Response at Day 42 in the Microbiological Modified Intent-to-Treat (Micro-mITT) Population|Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring >6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).|Day 42|Micro-mITT population included mITT participants with a Gram-positive pathogen isolated from blood and/or bone specimen. Participants whose cultures included both a Gram-positive and a Gram-negative pathogen are included.|||percentage of participants||95% Confidence Interval|Number
2559109|NCT02685033|Secondary|Percentage of Participants With Clinical Response at Day 42 in the mITT Population|Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring >6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).|Day 42|mITT population included all ITT participants who received any amount of randomized medication and met the criteria for known or suspected Gram-positive osteomyelitis. Participants from whom only a Gram-negative pathogen was isolated from blood and/or bone culture were excluded.|||percentage of participants||95% Confidence Interval|Number
2559110|NCT02685033|Secondary|Percentage of Participants With Clinical Improvement at Day 21 in the CE Population|Clinical improvement was defined as no worsening of pain from baseline, if present (subjective pain and/or point tenderness), and improvement in inflammation (as measured by C-reactive protein [CRP]).|Baseline to Day 21|CE-D21 population included all mITT (modified intent-to-treat) participants who met specific conditions for evaluability at Day 21 (D21).|||percentage of participants||95% Confidence Interval|Number
2559111|NCT02685033|Secondary|Percentage of Participants With Clinical Improvement at Day 21 in the mITT Population|Clinical improvement was defined as no worsening of pain from baseline, if present (subjective pain and/or point tenderness), and improvement in inflammation (as measured by C-reactive protein [CRP]).|Baseline to Day 21|mITT population included all ITT participants who received any amount of randomized medication and met the criteria for known or suspected Gram-positive osteomyelitis. Participants from whom only a Gram-negative pathogen was isolated from blood and/or bone culture were excluded.|||percentage of participants||95% Confidence Interval|Number
2559112|NCT02685033|Primary|Percentage of Participants With Clinical Response at Day 42 in the Clinically Evaluable (CE) Population|Clinical response was either cure, failure or indeterminate. A cure was defined as recovery without need for additional antibiotic therapy. A failure was defined as the requirement of additional antibiotic therapy for no response or worsening after improvement, new purulence, amputation due to progression of infection (from initiation of study drug to outcome assessment visit), requiring >6 weeks of antibiotic therapy for participants in the standard of care arm or death (for any reason). Indeterminate was defined as lost to follow-up or amputation due to vascular insufficiency (from initiation of study drug to outcome assessment visit).|Day 42|CE-D42 population included all modified intent-to-treat (mITT) participants who met specific conditions for evaluability at Day 42 (D42).|||percentage of participants||95% Confidence Interval|Number
2559113|NCT02685007|Secondary|Number of Participants With Intra-operative and Post-operative Adverse Events (AEs)||Baseline up to 13 days|The safety analysis set included all participants who were treated with TachoSil and completed the study.|||participants|||Number
2559114|NCT02685007|Secondary|Number of Participants With Pharmaco-economic Evaluation Based on Surgeon's Assessment|Pharmaco-economic evaluation based on surgeon's assessment included surgery time, intensive care unit (ICU) time, total care time, and other advantages. Other advantages included reduced or no risk of secondary bleeding, and the easier application and manageability.|Intra-surgery and post-surgery until hospital discharge (up to 13 days)|The safety analysis set included all participants who were treated with TachoSil and completed the study.|||participants|||Number
2559115|NCT02685007|Secondary|Duration of Hospital Stay||From date of surgery until hospital discharge (up to 13 days)|The safety analysis set included all participants who were treated with TachoSil and completed the study.|||days||Full Range|Median
2559116|NCT02685007|Primary|Investigators Assessment of Tachosil|Investigators were asked to evaluate the overall manageability and satisfaction with TachoSil in laparoscopic surgery. The overall manageability and satisfaction of TachoSil application was assessed using Likert scale. It is a 5-point scale, that ranges from 1-5, where 1=easy to use/satisfied to 5=difficult to use/not satisfied. Higher scores indicates difficulty and less satisfaction. The mean manageability satisfaction with the application of TachoSil were reported.|Post-surgery until hospital discharge (up to 13 days)|The safety analysis set included all participants who were treated with TachoSil and completed the study.|||score on a scale||Standard Deviation|Mean
2559117|NCT02684981|Secondary|Description of PACT-Q1 Items at Baseline|Patients in Cohort B were given PACT-Q1 to assess patients` expectation from Anticoagulation therapy. Following are the seven items from PACT-Q1. The score range is 1-5. Each question is analyzed individually, with higher score indicating better outcome. A1 - How confident are you that your anticoagulant treatment (AT) will prevent blood clots? A2 - Do you expect that your AT will relieve some of the symptoms you experience? A3 - Do you expect that your AT will cause side effects such as minor bruises or bleeding? A4 - How important is it for you to have an AT that is easy to take? A5 - How concerned are you about making mistakes when taking your AT? A6 - How important is it for you to take care of your AT by yourself? A7 - How concerned are you about how much you may have to pay for your AT? For questions A1, A2, A4 and A6, higher score is higher expectations of the treatment and for questions A3, A5 and A7, lower score is higher expectations of the treatment.|Baseline|Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information|||Percentage of patients (%)|||Number
2559118|NCT02684981|Primary|Stroke- and/or Bleeding Related Risk Factors in Medical History and at Baseline (Not Applicable)|This endpoint is not assessable as the necessary data was not collected in the database|Baseline|Treated set (Necessary data was not collected in the data base)||||||
2559119|NCT02684981|Secondary|PACT-Q2 Scores at Last Assessment Compared to Second Assessment|The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. Due to the non-normality of the data, results presented here are median change in PACT-Q2 scores between initiation stage (V2) and Continuation stage (V3).|From 30 days up to 210 days|Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.|||Unit on scale||Full Range|Median
2559120|NCT02684981|Primary|Duration in Months of Previous VKA Treatment|The data presented in this outcome measure are Mean (SD) of duration in months of previous VKA treatment in total patients in cohort A.|Baseline|Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.|||Months||Standard Deviation|Mean
2559121|NCT02684981|Primary|Characterization of Patients With Respect to Dosing of Pradaxa|The data presented in this outcome measure is percentage of patients in both cohorts receiving 110 mg and 150 mg dose of Pradaxa at baseline (V1).|Baseline and up to 210 days|Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.|||Percentage of patients (%)|||Number
2559122|NCT02684981|Primary|Characterization of Patients With Respect to Concomitant Therapies|Concomitant therapies are two or more drugs used or given at or almost at the same time. The data presented here are percentage of total patients for taking concomitant medication.|Baseline|Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.|||Percentage of patients (%)|||Number
2559123|NCT02684981|Primary|Characterization of Patients With Respect to Comorbidities|Comorbidity is the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder. Data presented here are percentage of total patients with comorbidities.|Baseline|Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.|||Percentage of patients (%)|||Number
2559124|NCT02684981|Primary|Characterization of Patients With Respect to Kidney Function (Creatinine Clearance)|Creatinine is a waste product produced by muscles from the breakdown of a compound called creatine. Creatinine is filtered from the blood by the kidneys and released into the urine. A creatinine clearance test measures creatinine levels in both a sample of blood and a sample of urine from a 24-hour urine collection. The results are used to calculate the amount of creatinine that has been cleared from the blood and passed into the urine. Data presented here are geometric mean and confidence interval of creatinine clearance for patients at baseline (V1), initiation stage (V2) and continuation stage (V3).|Baseline and up to 210 days|Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.|||millilitre per minute (mL/min)||95% Confidence Interval|Geometric Mean
2559125|NCT02684981|Primary|Characterization of Patients With Respect to Hypertension, Abnormal Renal and Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly (>65 Years), Drug and Alcohol (HAS-BLED) Score|HAS-BLED is a scoring system developed to assess 1-year risk of major bleeding in patients with atrial fibrillation. A calculated HAS-BLED score is between 0 and 9 and based on eight parameters with a weighted value of 0-2. A high score corresponds to a greater risk, while low score corresponds to a lower risk. Data presented are percentage of patients with high and low risk.|Baseline|Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.|||Percentage of patients (%)|||Number
2559126|NCT02684981|Primary|Characterization of Patients With Respect to Congestive Heart Failure, Hypertension, Age (≥75), Diabetes Mellitus, Stroke/Transient Ischemic Attack (TIA), Vascular Disease, Age 65-75, Sex Category (CHA2DS2-VASc) Score|CHA2DS2-VASc score, are clinical prediction rules for estimating the risk of stroke in patients with non-rheumatic atrial fibrillation (AF), a common and serious heart arrhythmia associated with thromboembolic stroke. Such a score is used to determine whether or not treatment is required with anticoagulation therapy or antiplatelet therapy. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. Score of < 2 was considered as low or intermediate risk and score of ≥ 2 was considered as high risk.|Baseline|Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.|||Percentage of patients (%)|||Number
2559127|NCT02684981|Primary|Satisfaction PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups|The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. The PACT-Q2 is to be administered to patients once treatment is ongoing. Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.|Day 30 up to Day 210|Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.|||Unit on scale||Full Range|Median
2559128|NCT02684981|Primary|Convenience PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups|The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. The PACT-Q2 is to be administered to patients once treatment is ongoing. Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.|Day 30 up to Day 210|Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.|||Unit on scale||Full Range|Median
2559129|NCT02684981|Primary|Satisfaction PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment|The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. The PACT-Q2 is to be administered to patients once treatment is ongoing. Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.|From baseline up to 210 days|Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.|||Unit on scale||Full Range|Median
2559130|NCT02684981|Primary|Convenience PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment|The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction. For each domain, a global score was calculated and used for analysis. The range of the global score is 0-100, with higher score indicating better outcome. The global score is calculated by summing up the individual scores, and then rescaled to 0-100. The PACT-Q2 is to be administered to patients once treatment is ongoing. Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.|From baseline up to 210 days|Main Analysis set (MAS): This includes all eligible patients who met inclusion/exclusion criteria with known assigned treatment information.|||Unit on scale||Full Range|Median
2559131|NCT02684942|Other Pre-specified|Fentanyl Dose|Sum of fentanyl dose when finish each fraction of brachytherapy|after complete treatment.|Participants received 4 fraction of brachytherapy. Thus all 160 fractions separated to two group of drug and analysis data in each group.|||ug.|fraction|Standard Deviation|Mean
2559132|NCT02684942|Other Pre-specified|Meperidine Dose|Sum of meperidine dose when finish each fraction of brachytherapy|after complete treatment.|Participants received 4 fraction of brachytherapy. Thus all 160 fractions separated to two group of drug and analysis data in each group.|||mg.|fraction|Standard Deviation|Mean
2559133|NCT02684942|Other Pre-specified|Tumor Size|Size of tumor at cervix measured by the doctor before insert applicator.|Before insert applicator in each fraction of brachytherapy.|Participants received 4 fraction of brachytherapy. Thus all 160 fractions separated to two group of drug and analysis data in each group.|||CM.|fraction|Standard Deviation|Mean
2559134|NCT02684942|Other Pre-specified|Ovoids Size|Size of ovoids that a pair part of brachytherapy applicator insert in vagina trough cervix.|after complete applicator insertion.|Each patient was treated with 4 fractions of brachytherapy.|||Centimeter|fraction|Full Range|Median
2559135|NCT02684942|Secondary|Quality of Life|Perceived Quality of life (EQ-5D) was assessed before the first brachytherpy and immediately after completion of each of the 4 brachytherapy fractions. The EQ-5D have 5 dimensions: mobility, self-care, usual activities, topics each content 3 responses: no problems, some problems, extreme problems.|From date of the first fraction of brachytherapy until date of the last fraction of brachytherapy,once a week for 4 weeks|Pain score in each fraction.|||participants|fraction||Number
2559136|NCT02684942|Primary|Pain Score|Perceived pain score according to standard 10-cm visual analog scales (VAS) was assessed before injection of medicine for every 15 minutes up to 120 minutes.The minimum and maximum scores were 0, 10. Score 0 means no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain and 10 worst pain.|From date of the first fraction until date of the last fraction of brachytherapy, once a week for four weeks||||units on a scale|fraction|Standard Deviation|Mean
2559137|NCT02684630|Primary|Donor Postprocedure Platelet Count Following Donation of Double Platelet Product|The primary endpoint for this study was the participant's postprocedure platelet count after completing a double platelet collection. A procedure was considered a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL.|The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis|The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.|||Participants|||Count of Participants
2559338|NCT02681172|Secondary|Number of Subjects With Negative FBB PET Scans|"PET image interpretation was performed locally in each centre by readers who had undergone training for appropriate interpretation of scans. Scans were interpreted as either positive or negative according to the approved visual assessment method."|Visit 3 (up to 6 months after baseline evaluation)||||Participants|||Count of Participants
2559138|NCT02684630|Primary|Donor Postprocedure Platelet Count Following Donation of Single Platelet Product|The primary endpoint for this study was the postprocedure participant platelet count for participants who have completed a single or double platelet collection. A procedure was a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL. A procedure was a failure if the participant's postprocedure platelet count was < 100,000 platelets/μL.|The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis|The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.|||Participants|||Count of Participants
2559139|NCT02684604|Primary|Quantitative Helicobacter Pylori IgG Assay in Serum|calculation of quantitative Helicobacter pylori IgG assay in serum|24 hours||||arbitrary unit per millilitre||Inter-Quartile Range|Median
2559140|NCT02684591|Other Pre-specified|Efficacy of Aramchol in Improving Imaging-based Biomarkers Associated With Changes in NAFLD|To examine the efficacy of aramchol in improving imaging-based biomarkers associated with changes in NAFLD|12 weeks|||||||
2559141|NCT02684591|Secondary|Efficacy of Aramchol 600 mg Orally Daily Versus Placebo in Improving Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels in Patients With HIV-associated NAFLD|To examine the efficacy of two doses of aramchol: 200 mg/tablet and 400 mg/tablet / day orally daily versus placebo in improving serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels in patients with HIV-associated NAFLD|12 Weeks||||IU/L||Full Range|Median
2559142|NCT02684591|Primary|Efficacy of Aramchol 600 mg vs. Placebo in Improving Hepatic Steatosis Assessed by Magnetic Resonance Imaging in Patients With HIV-associated NAFLD|To examine the efficacy of aramchol at 600 mg orally daily versus placebo in improving hepatic steatosis assessed by magnetic resonance imaging in patients with HIV-associated NAFLD|12 weeks||||% of fat||Full Range|Median
2559143|NCT02684435|Secondary|Sensitivity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard|Sensitivity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard|Baseline, 1 Year|Quantitative analysis unable to be conducted on cystic lesions and required solid portions, so data was not collected||||||
2559144|NCT02684435|Secondary|Specificity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard|Specificity of Quantitative Metrics Generated From CEUS in Diagnosing Kidney Malignancy in Patients With CKD and a Suspicious or Indeterminate Lesion on Non-contrasted Imaging Compared to the Truth Standard|Baseline, 1 Year|Quantitative analysis unable to be conducted on cystic lesions and required solid portions, so data was not collected||||||
2559145|NCT02684435|Primary|Specificity of Qualitative Interpretations of CEUS|PRELIMINARY RESULTS of specificity of qualitative interpretations of CEUS in diagnosing kidney malignancy in patients with CKD and a suspicious or indeterminate lesion on non-contrasted imaging compared to the truth standard|Baseline, 1 year||||percentage of negative scans|||Number
2559146|NCT02684435|Primary|Sensitivity of Qualitative Interpretations of CEUS in Diagnosing Kidney Malignancy|PRELIMINARY RESULTS of sensitivity of qualitative interpretations of CEUS in diagnosing kidney malignancy in patients with CKD and a suspicious or indeterminate lesion on non-contrasted imaging compared to the truth standard|Baseline, 1 year||||percentage of positive scans|||Number
2559147|NCT02684435|Primary|Number of Lesions With a Change in Radiologist's Evaluation|Lesions will be assessed for change in size, calcification, and septation based on Bosniak criteria (I, II, IIF, III, IV) to determine whether a lesion has progressed, regressed, or is stable.|Baseline, 1 year||||lesions|lesions||Number
2559148|NCT02684396|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648||Multiple time-points (up to 72 hours) post-dose|PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2559149|NCT02684396|Secondary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648||Multiple time-points (up to 72 hours) post-dose|PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2559150|NCT02684396|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-648||Multiple time-points (up to 72 hours) post-dose|PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.|||hours||Full Range|Median
2559151|NCT02684396|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-648||Multiple time-points (up to 72 hours) post-dose|PK Analysis Set included all enrolled participants who had at least 1 measureable plasma concentration.|||ng/mL||Standard Deviation|Mean
2559152|NCT02684396|Primary|Percentage of Participants With at Least One Occurrence of Severe Hypoglycemia Post-dose|Severe hypoglycemia is defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.|Day 1 to Day 4|Safety Analysis Set included all enrolled participants who received study drug.|||percentage of participants|||Number
2559153|NCT02684396|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs Measurements at Least Once Post-dose|Vital signs will include body temperature (oral), sitting blood pressure (after the participant has rested for at least 5 minutes), respiration rate and pulse (bpm).|Day 1 to Day 4|Safety Analysis Set included all enrolled participants who received study drug.|||percentage of participants|||Number
2559154|NCT02684396|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose|The percentage of participants with any markedly abnormal standard safety laboratory values (chemistry, hematology and urinalysis) collected throughout study.|Day 1 to Day 4|Safety Analysis Set included all enrolled participants who received study drug.|||percentage of participants|||Number
2559339|NCT02681172|Secondary|Number of Subjects With Positive FBB PET Scan|"PET image interpretation was performed locally in each centre by readers who had undergone training for appropriate interpretation of scans. Scans were interpreted as either positive or negative according to the approved visual assessment method."|Visit 3 (up to 6 months after baseline evaluation)||||Participants|||Count of Participants
2559155|NCT02684396|Primary|Percentage of Participants Who Have at Least One Treatment-Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 to Day 14|Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2559156|NCT02684370|Secondary|PSS Total Score: Change From Baseline to Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)|The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. A negative change from Baseline indicates improvement. Last observation carried forward (LOCF) imputation was used for missing data.|Baseline, Week 16|ITT population. Last observation carried forward. Participants randomized to placebo or risankizumab with an observed baseline PSS and at least one post-baseline PSS observation on or prior to Week 16.|||units on a scale||Standard Error|Least Squares Mean
2559157|NCT02684370|Secondary|Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)|DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired.). A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559158|NCT02684370|Secondary|Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 12|ITT population|||percentage of participants|||Number
2559159|NCT02684370|Secondary|Percentage of Participants Achieving PASI75 at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 12|ITT population|||percentage of participants|||Number
2559160|NCT02684370|Secondary|Percentage of Participants Achieving sPGA Score of Clear at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 52|ITT population. Non-responder imputation. Analysis performed on all participants randomized to ustekinumab or risankizumab treatment in Part A.|||percentage of participants|||Number
2559161|NCT02684370|Secondary|Percentage of Participants Achieving PASI100 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.|Week 52|ITT population. Non-responder imputation. Analysis performed on all participants randomized to ustekinumab or risankizumab treatment in Part A.|||percentage of participants|||Number
2559162|NCT02684370|Secondary|Percentage of Participants Achieving PASI90 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.|Week 52|ITT population. Non-responder imputation. Analysis performed on all participants randomized to ustekinumab or risankizumab treatment in Part A.|||percentage of participants|||Number
2559381|NCT02680756|Primary|Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb (>12g/dL Women, >13g/dL Men) at Week 12|Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (>12g/dL women, >13g/dL men) at Week 12 results per protocol (PP)|Baseline to Week 12|results per protocol (PP)|||Participants|||Count of Participants
2559163|NCT02684370|Secondary|Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559164|NCT02684370|Secondary|Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559165|NCT02684370|Secondary|Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559166|NCT02684370|Secondary|Percentage of Participants Achieving PASI90 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559167|NCT02684370|Secondary|Percentage of Participants Achieving Psoriasis Symptoms Scale (PSS) Total Score of 0 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)|The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS total score is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559168|NCT02684370|Secondary|Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)|DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired.). A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559169|NCT02684370|Secondary|Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559170|NCT02684370|Secondary|Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559171|NCT02684370|Primary|Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559172|NCT02684370|Primary|Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Nonresponder imputation (NRI) was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559173|NCT02684357|Secondary|Percentage of Participants Achieving PASI75 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 52|ITT population. Non-responder imputation. Analysis performed on all participants randomized to ustekinumab or risankizumab treatment in Part A.|||percentage of participants|||Number
2559174|NCT02684357|Secondary|Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 52|ITT population. Non-responder imputation. Analysis performed on all participants randomized to ustekinumab or risankizumab treatment in Part A.|||percentage of participants|||Number
2559175|NCT02684357|Secondary|Percentage of Participants Achieving PASI75 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559176|NCT02684357|Secondary|Change From Baseline to Week 16 in PSS Total Score in Participants Who Received Risankizumab Compared With Placebo (Part A)|The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. A negative change in PSS total score indicates improvement. Last observation carried forward (LOCF) imputation was used for missing data.|Week 16|ITT population. Last observation carried forward. Participants randomized to placebo or risankizumab with an observed baseline PSS and at least one post-baseline PSS observation on or prior to Week 16.|||units on a scale||Standard Error|Least Squares Mean
2559177|NCT02684357|Secondary|Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)|DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559178|NCT02684357|Secondary|Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 12|ITT population|||percentage of participants|||Number
2559179|NCT02684357|Secondary|Percentage of Participants Achieving PASI75 at Week 12 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 12|ITT population|||percentage of participants|||Number
2559180|NCT02684357|Secondary|Percentage of Participants Achieving sPGA Score of Clear at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 52|ITT population. Non-responder imputation. Analysis performed on all participants randomized to ustekinumab or risankizumab treatment in Part A.|||percentage of participants|||Number
2559181|NCT02684357|Secondary|Percentage of Participants Achieving PASI100 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI00 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 52|ITT population. Non-responder imputation. Analysis performed on all participants randomized to ustekinumab or risankizumab treatment in Part A.|||percentage of participants|||Number
2559182|NCT02684357|Secondary|Percentage of Participants Achieving PASI90 at Week 52 in Participants Who Received Risankizumab Compared With Ustekinumab (Part B)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 52|ITT population. Non-responder imputation. Analysis performed on all participants randomized to ustekinumab or risankizumab treatment in Part A.|||percentage of participants|||Number
2559183|NCT02684357|Secondary|Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559184|NCT02684357|Secondary|Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI00 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559185|NCT02684357|Secondary|Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559186|NCT02684357|Secondary|Percentage of Participants Achieving PASI90 at Week 16 in Participants Who Received Risankizumab Compared With Ustekinumab (Part A)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559187|NCT02684357|Secondary|Percentage of Participants Achieving a Psoriasis Symptom Scale (PSS) Score of 0 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)|The PSS asks the participant to rate the severity of symptoms of psoriasis in the last 24 hours (pain, redness, itching, and burning) using a 5-point Likert -type scale ranging from 0 (none) to 4 (very severe). The PSS is calculated by summing the scores of the questions and ranges from 0 to 16, where the higher the score, the greater the severity of psoriasis symptoms. NRI was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559244|NCT02683746|Secondary|Number of Participants With Positive Result for Anti-albiglutide Antibody|Blood samples were obtained from participants at specific time points before administration of study treatment. The presence of anti-albiglutide antibodies was assessed using a validated enzyme linked immunosorbent assay (ELISA). The assay involves screening, confirmation, and titration steps (tiered-testing approach). Number of participants with positive anti- albiglutide antibody results at 'any visit post-Baseline' are presented.|Up to Week 34|Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.|||Participants|||Number
2559188|NCT02684357|Secondary|Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)|DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. NRI was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559189|NCT02684357|Secondary|Percentage of Participants Achieving PASI100 at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 16|ITT population.|||percentage of participants|||Number
2559190|NCT02684357|Secondary|Percentage of Participants Achieving sPGA Score of Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559191|NCT02684357|Primary|Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 16|ITT population|||percentage of participants|||Number
2559192|NCT02684357|Primary|Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A)|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data.|Week 16|Intent-to-treat (ITT) population: all randomized participants.|||percentage of participants|||Number
2559193|NCT02684344|Primary|Number of Participants With Post-operative Urinary Retention||5 days||||Participants|||Count of Participants
2559194|NCT02684188|Primary|Primary Care Provider (PCP) Visits Analyzed by Logistic Regression|This reflects the proportion of patients who reported at least one visit to a their local primary care provider at 3, 7, 14, 21,30, 60, and 90 days after discharge.|3, 7, 14, 21, 30, 60, and 90 days after discharge|Patients between 18 and 75 years old admitted to a regional referral hospital for treatment, who enrolled in the study and were discharged to one of four rural counties.|||Proportion with Primary Care Visits|||Number
2559195|NCT02684188|Secondary|Rural Transition Measure (RTM14)|The RTM14 is a fourteen-item questionnaire to measures patients' perspectives on the delivery of transition services and supports after discharge from a regional hospital to a small town or rural community. Patients respond by indicating whether they strongly disagree, disagree, agree, or strongly agree with each of the 14 items. Patients may also indicate whether an item is not applicable to their situation. Ratings are converted to a scale that ranges from 0 to 100. Higher scores reflect better transition service performance.|7, 14, 21, 30, 60, and 90 days after discharge|Patients between 18 and 75 years old admitted to regional referral hospital for treatment, who enrolled in study and were discharged to one of four rural counties|||Survey Response Scores||Standard Deviation|Mean
2559196|NCT02684188|Secondary|Care Transition Measure (CTM3)|The CTM3 is a three-item standardized questionnaire to measures patients' perspectives on coordination of hospital discharge care. Patients rate whether they strongly agree, agree, disagree, or strongly disagree with three items (hospital staff too my preferences into account, I had a good idea what I was responsible for once I left the hospital, and I clearly understood the purpose for taking each of my medications). They may also rate an items as not applicable to their situation. Ratings are converted to a scale that ranges from 0 to 100. Higher scores reflect better discharge care.|3 days after discharge|Patients between 18 and 75 years old admitted to regional referral hospital for treatment, who enrolled in study and were discharged to one of four rural counties|||Survey Response Scores||Standard Deviation|Mean
2559258|NCT02683668|Primary|Peripheral Airways Resistance (R5-R20)|Peripheral airways resistance measured by impulse oscillometry (IOS). Specific frequencies relate to different levels: a frequency of 5 hertz (Hz) provides values for total airway resistance (R5) and reactance (X5); a 20Hz frequency gives a value for central or large airway resistance (R20); and if one subtracts the value of central airway resistance from that for total airway resistance (i.e. R5-R20), this provides a measure of peripheral or small airways resistance.|6 months||||kPa/l/s||Standard Deviation|Mean
2559197|NCT02684188|Secondary|Short Form (SF12) Mental Health Score|The SF12 is a twelve-item standardized questionnaire that measures overall, physical health, and mental health. Patients rate each item on an ordinal scale. Data are analyzed using a proprietary algorithm. Scores range from 0 to 100. Higher scores reflect a better health status. The analysis creates an overall health score and sub scores that reflect physical health and mental health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm of a mean score of 50.0 and a standard deviation of 10.0.|3, 7, 14, 21, 30, 60, and 90 days after discharge|Patients between 18 and 75 years old admitted to regional referral hospital for treatment, who enrolled in study and were discharged to one of four rural counties|||units on a scale||Standard Deviation|Mean
2559198|NCT02684188|Secondary|Short Form (SF12) Physical Health Score|The SF12 is a twelve-item standardized questionnaire that measures overall, physical health, and mental health. Patients rate each item on an ordinal scale. Data are analyzed using a proprietary algorithm. Scores range from 0 to 100. Higher scores reflect a better health status. The analysis creates an overall health score and sub scores that reflect physical health and mental health. Both Physical and Mental Health Composite Scales combine the 12 items in such a way that they compare to a national norm of a mean score of 50.0 and a standard deviation of 10.0.|3, 7, 14, 21, 30, 60, and 90 days after discharge|Patients between 18 and 75 years old admitted to regional referral hospital for treatment, who enrolled in study and were discharged to one of four rural counties|||units on a scale||Standard Deviation|Mean
2559199|NCT02684188|Primary|Primary Care Provider (PCP) Visits Analyzed by Poisson Regression|This reflects the number of visits to a patient's local primary care provider at 3, 7, 14, 21,30, 60, and 90 days after discharge.|3, 7, 14, 21, 30, 60, and 90 days after discharge|Patients between 18 and 75 years old admitted to a regional referral hospital for treatment, who enrolled in the study and were discharged to one of four rural counties.|||Primary Care Provider Visits|||Number
2559200|NCT02684188|Primary|Emergency Department (D) Visits Analyzed by Logistic Regression|Proportion of patients who report at least one emergency department visit after discharge from a regional hospital to one of four rural counties.|3, 7, 14, 21,30, 60, and 90 days after discharge|Patients between 18 and 75 years old admitted to regional referral hospital for treatment, who enrolled in study and were discharged to one of four rural counties|||participants with at least one ED visit|||Number
2559201|NCT02684188|Primary|Emergency Department (ED) Visits Analyzed by Poisson Regression|Number of self-reported visits to the emergency department of any hospital reported by patients after discharge from a regional hospital to one of four rural counties.|3, 7, 14, 21,30, 60, and 90 days after discharge|Patients between 18 and 75 years old admitted to regional referral hospital for treatment, who enrolled in study and were discharged to one of four rural counties|||Emergency Department Visits|||Number
2559202|NCT02684188|Primary|Hospital Re-admissions Analyzed by Logistic Regression|Proportion of patients who self-report at least one hospital readmission to any hospital after discharge from a regional hospital to one of four rural counties.|3, 7 ,14, 21, 30, 60, and 90 days after discharge|Patients between 18 and 75 years old admitted to regional referral hospital for treatment, who enrolled in study and were discharged to one of four rural counties|||proportion of patients rehospitalized|||Number
2559203|NCT02684188|Primary|Hospital Re-admissions Analyzed by Poisson Regression|Number of admissions to any hospital reported by the patients after discharge from a regional hospital to one of four rural counties.|3, 7 ,14, 21, 30, 60, and 90 days after discharge|Patients between 18 and 75 years old admitted to regional referral hospital for treatment, who enrolled in study and were discharged to one of four rural counties|||Hospital Readmission|||Number
2559204|NCT02684097|Other Pre-specified|Number of Adverse Events|Side effects to study the safety of tralokinumab in patients with moderate to severe alopecia areata and in patients with concomitant moderate to severe alopecia areata and atopic dermatitis|Week 40||||events|||Number
2559205|NCT02684097|Secondary|Percentage Change From Baseline in the Alopecia Areata Quality of Life Questionnaire (AA-QoL)|Percentage change from Baseline in the Alopecia Areata Quality of Life questionnaire (AA-QoL) at Week 24. AA-QoL score 0-100 with higher score indicating better health outcomes.|Baseline and Week 24||||percentage change||Standard Deviation|Mean
2559206|NCT02684097|Secondary|Percentage Change From Baseline in the Alopecia Areata Symptom Impact Scale (AASIS)|"Percentage change from baseline in the Alopecia Areata Symptom Impact Scale (AASIS) at Week 24.~AASIS score 0-130 with lower score indicating better health outcomes."|Baseline and Week 24||||percent change||Standard Deviation|Mean
2559207|NCT02684097|Secondary|Number of Patients Achieving 50% or Greater Improvement in Their SALT Score (SALT50)|Number of patients achieving 50% or greater improvement in their SALT score (SALT50) at Week 24, compared to Baseline. SALT score 0-100 with lower score indicating better health outcomes.|Baseline and Week 24||||Participants|||Count of Participants
2559208|NCT02684097|Secondary|Percentage Change From Baseline in the Severity of Alopecia Tool (SALT)|"Percentage change from Baseline in the Severity of Alopecia Tool (SALT) at Week 24.~SALT score 0-100 with lower score indicating better health outcomes."|Week 24||||percentage change||Standard Deviation|Mean
2559209|NCT02684097|Primary|"Change in Gene Expression Th2/IL-13, T22/IL-22, S100A7 and S100A8, Th1/IFN-gamma, and Th17/IL-17A Jointly Correlated"|"Change from baseline in cellular, and molecular markers in skin biopsies after treatment. Gene expression changes in Th2/IL-13, T22/IL-22, S100A7 and S100A8, Th1/IFN-gamma, and Th17/IL-17A jointly correlated assessed as change at week 24 compared to baseline of the biomarkers combined z-score expression. Th2/IL-13, T22/IL-22, S100A7 and S100A8, Th1/IFN-gamma, and Th17/IL-17A biomarkers was computed as following. The combined score was obtained by mean z-score expression of all biomarkers, where z-score normalized expression of biomarker X and sample i was obtained by the following formula:~[Xi - mean(Xall_samples)]/sd(Xall_samples). Change in combined z-score for each patient was calculated from two time points as the value at the later time point minus the value at the earlier time point."|Baseline and Week 24|data only for those participants who had a biopsy. No participants in placebo group had a biopsy.|||z-score||Standard Deviation|Mean
2559275|NCT02683174|Secondary|Number of Participants Who Agreed or Strongly Agreed That the Patch Monitor Was Easy to Use.|Number of participants who agreed or strongly agreed that the patch monitor was easy to use. Patient patch satisfaction (postal questionnaire).|90 days|All study participants who returned the participant patch satisfaction postal questionnaire (n=47).|||Participants|||Count of Participants
2559210|NCT02683954|Primary|Serum Nesfatin 1|"Venous samples for measurement of nesfatin-1 were taken by venipuncture from patients during the laparoscopy procedure immediately after initial evaluation and before any intervention.The blood samples were centrifuged immediately after their collection at 5000 rpm for 10 min and serum samples were stored at -20 °C until analysis. Nesfatin-1 was measured by Enzyme-Linked Immuno Sorbent Assay ELISA technique using commercially available kits (Boster Biological Technology Human Nesfatin-1 ELISA kits, Catalog number EK1138, USA) in the Central Labs of Ain Shams University Hospitals."|24 hours|In the endometriosis group, two patients were stage I, one was stage II, 12 were stage III and 15 were stage IV according to the revised ASRM scoring system. In the control group, 13 had polycystic varies, 11 had variable pelvic peritoneal adhesions, 4 had tubal block , one had unilateral ovarian cyst and one patient had atrophic ovaries.|||picogram/millilitre||Inter-Quartile Range|Median
2559211|NCT02683889|Secondary|Renal Function After Transplantation|By measurement of the estimated glomerular filtration rate with patient's creatinine|1 year|Study ended early - Data analysis not completed on partial data set||||||
2559212|NCT02683889|Primary|Rate of Recurrence of Proteinuria|By measurement of urine protein and urine creatinine ratio|2 years|Study ended early - Data analysis not completed on partial data set||||||
2559213|NCT02683889|Primary|Rate of Recurrence of FSGS as Seen in Renal Transplant Biopsies Proteinuria|This will be studied in the renal transplant biopsies|2 years|Study ended early - Data analysis not completed on partial data set||||||
2559214|NCT02683785|Secondary|Serum Concentration of GSK3196165 by Visit|Blood samples were collected at indicated time points for pharmacokinetic analysis.|Pre-dose on Day 3, Weeks 1, 4, 6, 12, follow up (Week 22)|PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2559215|NCT02683785|Secondary|Absoption Rate Constant (Ka) of GSK3196165|Blood samples were collected at indicated time points and Ka was estimated using population PK analysis.|Day 3 and Pre-dose on Week 1, Week 4, Week 6, Week 12 and Week 22|PK Population|||Per day||Geometric Coefficient of Variation|Geometric Mean
2559216|NCT02683785|Secondary|Apparent Steady State Volume of Distribution After Subcutaneous Administration (Vss/F) of GSK3196165|Blood samples were collected at indicated time points and Vss/F was estimated using population PK analysis.|Day 3 and Pre-dose on Week 1, Week 4, Week 6, Week 12 and Week 22|PK Population.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2559217|NCT02683785|Secondary|Apparent Clearance After Subcutaneous Administration (CL/F) of GSK3196165|Blood samples were collected at indicated time points and CL/F was estimated using population PK analysis. Participants in the 'Safety' population who have at least one valid PK assessment were included Pharmacokinetic (PK) Population.|Day 3 and Pre-dose on Week 1, Week 4, Week 6, Week 12 and Week 22|PK Population|||Liters per day||Geometric Coefficient of Variation|Geometric Mean
2559218|NCT02683785|Secondary|Number of Participants With Anti-GSK3196165 Binding Antibodies|Serum samples were collected at indicated time points for anti-drug antibody (ADA) measurements. Anti-GSK3196165 binding antibody detection assay using tiered testing schema: screening, confirmation and titration steps was used for immunogenicity analysis. Samples taken after dosing with GSK3196165 that have a value at or above the cut-point were considered treatment-emergent ADA-positive. The number of participants with change from Baseline to any time post Baseline in the results of immunogenicity assessment as indicated by: negative to positive, positive to positive, positive to negative and negative to negative are presented.|Up to Week 22|Intent-to-Treat Population. Only those participants with data available post-Baseline are reported.|||Participants|||Count of Participants
2559219|NCT02683785|Secondary|Number of Participants With Pulmonary Events|Pulmonary events like pulmonary alveolar proteinosis (PAP), persistent (for 3 consecutive weeks) reduction in diffusing capacity of the lungs for carbon monoxide (DLCO) > 15 percentage, persistent (for 3 consecutive weeks) cough and/or dyspnea and non- life threatening pulmonary changes related to surfactant accumulation is presented.|Up to Week 22|Safety Population|||Participants|||Count of Participants
2559220|NCT02683785|Secondary|Number of Participants With Infections|Adverse events of special interest (AESI) included serious infections like serious respiratory infections and tuberculosis and other opportunistic infections. Number of participants with infections has been reported.|Up to Week 22|Safety Population|||Participants|||Count of Participants
2559221|NCT02683785|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or events associated with liver injury and impaired liver function were categorized as SAE. All participants who received at least one dose of study treatment (GSK3196165 or placebo) were included in Safety Population.|Up to Week 22|Safety Population|||Participants|||Count of Participants
2559222|NCT02683785|Secondary|Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity|Participants were required to complete the global assessment of disease activity using single PtGA item with an NRS ranging from 0 (very well) to 10 (very poor). Baseline was defined as Day 1 pre-dose value. Change from Baseline is equal to post-dose visit value minus Baseline value.|Baseline, Weeks 2, 4, 8, and 12|Intent-to-Treat Population. n=X in category titles represents the number of participants with non-missing data at the specified time-point. Only non-missing data is included in the MMRM model.|||Scores on scale||Standard Error|Least Squares Mean
2559223|NCT02683785|Secondary|Change From Baseline in Physician Global Assessment (PhGA) of Disease Activity|Physicians were required to complete the global assessment of disease activity using single PhGA item with a NRS ranging from 0 (none) to 10 (extremely active). Baseline was defined as Day 1 pre-dose value. Change from Baseline is equal to post-dose visit value minus Baseline value.|Baseline (Day 1 Pre-dose), Weeks 2, 4, 8, and 12|Intent-to-Treat Population. n=X in category titles represents the number of participants with non-missing data at the specified time-point. Only non-missing data is included in the MMRM model.|||Scores on scale||Standard Error|Least Squares Mean
2561387|NCT02650921|Secondary|Question 6 From Subject Satisfaction Questionnaire|Question 6: My treated hand looks less bony than my untreated hand|Week 12|ITT|||Participants|||Count of Participants
2559224|NCT02683785|Secondary|Change From Baseline in Number of Tender Hand Joints at Each Visit|Tender Hand Joint Count was measured by the total number of tender joints out of a possible 30 joints: 8 distal interphalangeal, 8 proximal interphalangeal, 2 interphalangeal joints, 10 metacarpophalangeal joints, 2 carpometacarpal joints across both hands. A joint was considered tender if it was scored >0 on the tender joint severity scale. Joints were rated 0=no pain/tenderness, 1=mild pain, 2=moderate pain and 3=severe pain. Baseline is defined as Day 1 pre-dose value. Change from Baseline is equal to post-dose visit value minus Baseline value.|Baseline, Weeks 1, 2, 4, 6, 8, 10, and 12|Intent-to-Treat Population. n=X in category titles represents the number of participants with non-missing data at the specified time-point. Only non-missing data was included in the MMRM model.|||Scores on scale||Standard Error|Least Squares Mean
2559225|NCT02683785|Secondary|Change From Baseline in Number of Soft Tissue Swollen Hand Joints at Each Visit|Swollen Hand Joint Count was measured by the total number of soft tissue swollen hand joints out of a possible 30 joints: 8 distal interphalangeal, 8 proximal interphalangeal, 2 interphalangeal joints, 10 metacarpophalangeal joints, 2 carpometacarpal joint across both hands. In case of missing observations for soft tissue swollen hand joints then the remaining observations were assessed and weighted by dividing the number presented by the number of non-missing, and by multiplying by 30 for the joint count. Baseline is defined as Day 1 pre-dose value. Change from Baseline is equal to post-dose visit value minus Baseline value.|Baseline (Day 1 Pre-dose), Weeks 1, 2, 4, 6, 8, 10, and 12|Intent-to-Treat Population. n=X in category titles represents the number of participants with non-missing data at the specified time-point. Only non-missing data is included in the MMRM model.|||Swollen joints||Standard Error|Least Squares Mean
2559226|NCT02683785|Secondary|Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.|"The AUSCAN Index is a self-administered questionnaire consisting of a 15-item scale which measures pain (5 items), stiffness (1 item) and degree of disability/physical function (9 items) during the preceding 48 hours. All items are rated on NRS scale with anchors 0 (none) to 10 (extreme). The scores for the pain and physical function components were calculated as simple summation of the item scores relating to that domain, so the Pain component ranges from 0 (i.e. all pain item scores are scored 0 [none]) to 50 (i.e. all pain item scores are scored 10 [extreme]), and the Physical Function component ranges from 0 (i.e. all physical function item scores are scored 0 [none]) to 90 (i.e. all physical function item scores are scored 10 [extreme]). The total AUSCAN score was calculated as simple summation of the 15 item scores and therefore ranges from 0 to 150. Baseline is defined as Day 1 pre-dose value. Change from Baseline is equal to post-dose visit value minus Baseline value."|Baseline (Day 1 Pre-dose), Weeks 1, 2, 4, 6, 8, 10, and 12|Intent-to-Treat Population. n=X in category titles represents the number of participants with non-missing data at the specified time-point. Only non-missing data is included in the MMRM model.|||Scores on scale||Standard Error|Least Squares Mean
2559227|NCT02683785|Secondary|Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit|Participants were required to complete worst pain NRS daily and rate the hand pain at its worst over last 24 hours on a scale of 0 (no pain) to 10 (worst imaginable pain). The percentage of participants achieving at least 50 percentage reduction from Baseline in the 24-hours worst hand pain intensity as measured by daily NRS and averaged over 7 days prior to each visit is presented.|Baseline (Pre-dose, Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12 and follow up (Week 22)|Intent-to-Treat Population. Participants with missing data at a particular visit had been assumed to be non-responders.|||Percentage of participants|||Number
2559228|NCT02683785|Secondary|Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit|Participants were required to complete worst pain NRS daily and rate the hand pain at its worst over last 24 hours on a scale of 0 (no pain) to 10 (worst imaginable pain). The percentage of participants achieving at least 30 percentage reduction from Baseline in the 24-hours worst hand pain intensity as measured by daily NRS and averaged over 7 days prior to each visit is presented.|Baseline (Pre-dose, Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12 and follow up (Week 22)|Intent-to-Treat Population. Participants with missing data at a particular visit had been assumed to be non-responders.|||Percentage of participants|||Number
2559229|NCT02683785|Secondary|Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit|Participants were required to complete average pain NRS daily and rate the average hand pain over last 24 hours on a scale of 0 (no pain) to 10 (worst imaginable pain). The percentage of participants who achieved at least 50 percentage reduction from Baseline in the 24-hours average hand pain intensity as measured by daily NRS and averaged over 7 days prior to each visit is presented.|Baseline (Pre-dose, Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12 and follow up (Week 22)|Intent-to-Treat Population. Participants with missing data at a particular visit had been assumed to be non-responders.|||Percentage of participants|||Number
2559230|NCT02683785|Secondary|Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit|Participants were required to complete average pain NRS daily and rate the average hand pain over last 24 hours on a scale of 0 (no pain) to 10 (worst imaginable pain). The percentage of participants who achieved at least 30 percentage reduction from Baseline in the 24-hours average hand pain intensity as measured by daily NRS and averaged over 7 days prior to each visit is reported.|Baseline (Pre-dose, Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12 and follow up (Week 22)|Intent-to-Treat Population. Participants with missing data at a particular visit had been assumed to be non-responders.|||Percentage of participants|||Number
2559231|NCT02683785|Secondary|Change From Baseline of Worst Hand Pain Intensity Over 24 Hours Averaged Over the 7 Days Prior to Each Visit|"Participants were required to complete a daily pain NRS based on their 24-hour worst hand pain intensity with the anchors 0 (no pain) and 10 (worst imaginable pain), which was averaged over the 7 days prior to assessment visit. The score is calculated as sum of daily 24 hours worst hand pain NRS scores in the 7 days prior to assessment visit, divided by number of entries recorded in those 7 days. Baseline visit was at Day 1 and Baseline value was defined as the average of the 7 days prior to baseline visit (Day 1 pre-dose). Change from Baseline is equal to post-dose visit value minus Baseline value."|Baseline (Pre-dose Day 1), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Intent-to-Treat Population. n=X in category titles represents the number of participants with non-missing data at the specified time-point. Only non-missing data is included in the MMRM model.|||Scores on scale||Standard Error|Least Squares Mean
2559232|NCT02683785|Secondary|Change From Baseline in 24 Hours Average Hand Pain Intensity Averaged Over the 7 Days Prior to Each Visit|"Participants were required to complete a daily pain NRS based on their 24-hour average hand pain intensity with the anchors 0 (no pain) and 10 (worst imaginable pain), which was averaged over the 7 days prior to assessment visit. The 7 day average score is calculated by sum of daily 24 hours average hand pain NRS scores in the 7 days prior to assessment visit, divided by number of entries recorded in those 7 days. Baseline visit was at Day 1 and Baseline value was defined as the average of the 7 days prior to baseline visit (Day 1 pre-dose). Change from Baseline is equal to post-dose visit value minus Baseline value."|Baseline (Pre-dose Day 1), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Intent To Treat Population. n=X in category titles represents the number of participants with non-missing data at the specified time-point. Only non-missing data is included in the MMRM model.|||Scores on scale||Standard Error|Least Squares Mean
2559233|NCT02683785|Primary|Change From Baseline in 24-hour Average Hand Pain Intensity, Averaged Over the 7 Days Prior to Week 6|"Participants were required to complete a daily pain NRS based on their 24-hour average hand pain intensity with the anchors 0 (no pain) and 10 (worst imaginable pain), which was averaged over the 7 days prior to assessment visit. The 7 day average score was calculated as sum of daily 24 hours average hand pain NRS scores in the 7 days prior to assessment visit, divided by number of entries recorded in those 7 days. Baseline visit was at Day 1 and Baseline value was defined as the average of the 7 days prior to baseline visit (Day 1 pre-dose). Change from Baseline is equal to post-dose visit value minus Baseline value. Intent-To-Treat Population comprised of all randomized participants who received at least one dose of study treatment (GSK3196165 or placebo)."|Baseline (Day 1 Pre-dose) and Week 6|Intent To Treat Population. Only non-missing data is included MMRM model.|||Scores on scale||Standard Error|Least Squares Mean
2559234|NCT02683772|Secondary|Arterial Carbon Dioxide (PCO2)|To assess Sleep-breathing parameters between groups using mean PCO2 (mmHg)|Overnight, up 8 hrs on night 1 and 2|Analysis population in each arm/group is based on the total number of participants receiving each intervention over two separate nights.|||milimeters of mercury||Standard Deviation|Mean
2559235|NCT02683772|Secondary|Nadir Arterial Oxygen Saturation (SpO2)|To assess Sleep-breathing parameters between groups using mean SpO2 (%)|Overnight, up 8 hrs on night 1 and 2|Analysis population in each arm/group is based on the total number of participants receiving each intervention over two separate nights.|||percentage of oxygen saturation||Standard Deviation|Mean
2559236|NCT02683772|Secondary|Apnea Hypopnea Index (AHI)|To assess sleep-breathing parameters between groups using mean AHI (#events/hour)|Overnight, up 8 hrs on night 1 and 2|Analysis population in each arm/group is based on the total number of participants receiving each intervention over two separate nights.|||events per hour||Standard Deviation|Mean
2559237|NCT02683772|Secondary|Sleep Efficiency (%)|To assess sleep efficacy between groups by using rapid eye movement sleep (REM) (% of total sleep time)|Overnight, up to 8 hrs on nights 1 and 2||||percentage of total sleep time||Standard Deviation|Mean
2559238|NCT02683772|Primary|Oxygen Desaturation Index 4% (ODI4%)|Mean paired difference AutoEPAP-manual EPAP: Comparison of Oxygen Desaturation Index 4% (ODI4%) values between groups by using mean ODI4% (#events/hour). A cross-over analysis was generated to investigate the influence of a possible period effect on the primary endpoint, paired change in ODI4% between Auto and manual EPAP|Overnight, up to 8 hrs on nights 1 and 2|This is a crossover study. There were 42 patients enrolled in total. 38 patients met the definition of evaluable. These 38 participated in both 'Group A' and 'Group B' intervention assignments. All Baseline characteristics are summarized for these 38 evaluable patients.|||events per hour||Standard Deviation|Mean
2559239|NCT02683746|Secondary|Trough Plasma Concentration of Albiglutide Over Time|Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of albiglutide. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose at Week 12 and Week 26|PK Population|||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2559240|NCT02683746|Secondary|Change From Baseline in FPG Over Time|Blood samples were collected from participants at specific time points to evaluate FPG to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to Week 26|ITT Population|||Mmol/L||Standard Error|Least Squares Mean
2559241|NCT02683746|Secondary|Change From Baseline in HbA1c Over Time|Blood samples were collected from participants at specific time points to evaluate HbA1c to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model and model-adjusted least square mean (LS mean) and standard error have been presented. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to Week 26|ITT Population|||Percent of total hemoglobin||Standard Error|Least Squares Mean
2559242|NCT02683746|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|Blood samples were collected from participants at specific time points to evaluate FPG to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a MMRM model.|Baseline and Week 26|ITT Population. Only those participants available at Week 26 were analyzed.|||Mmol/L||Standard Error|Least Squares Mean
2559243|NCT02683746|Secondary|Number of Participants With Injection Site Reactions (ISR)|Number of participants with ISR incidences were evaluated at specific time points. Each week included those participants with the onset of an ISR during that particular week as well as those participants with ISR from previous weeks that have not resolved.|Up to Week 34|Safety Population.|||Participants|||Number
2559276|NCT02683174|Secondary|Number of Participants With Arrhythmia|Prevalence of arrhythmia including serious significant arrhythmia, significant arrhythmia and symptomatic arrhythmia in ED syncope patients unexplained after ED evaluation.|90 days||||Participants|||Count of Participants
2559277|NCT02683174|Secondary|Median Time to Detection of Significant Symptomatic Arrhythmia|Median time to detection of significant symptomatic arrhythmia by ambulatory patch monitor|90 days||||days||Inter-Quartile Range|Median
2559245|NCT02683746|Secondary|Number of Participants With Electrocardiogram (ECG) Parameters of PCC|Single measurements of 12-lead ECG were obtained in semi recumbent position using an ECG machine that automatically calculates the heart rate and measures PR and QT interval corrected for heart rate according to Fridericia's formula (QTcF). Number of participants with ECG values of PCC at 'any visit post-Baseline' are presented. ECG mean heart rate values <50 or >120, PR interval >300 milliseconds (msec), QRS interval >200 msec, QTcF interval >=500 msec were considered as PCC values. Number of participants with PCC values of ECG parameters for 'any visit post-Baseline' are presented.|Up to Week 26|Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.|||Participants|||Number
2559246|NCT02683746|Secondary|Number of Participants With Vital Signs of PCC|Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate were measured in a seated position after at least 5 minutes of rest. SBP values <100 millimeters of mercury (mmHg) and >170 mmHg, DBP values <50 mmHg and >110 mmHg, pulse rate values <50 beats per minute (bpm) and >120 bpm were considered as PCC values. Number of participants with PCC values of vital signs for 'any visit post-Baseline' are presented.|Up to Week 34|Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.|||Participants|||Number
2559247|NCT02683746|Secondary|Number of Participants With Hematology Parameters of PCC|Hematology parameters for which PCC values were identified were hematocrit (if value >0.05 below LLN or >0.04 above ULN), Hemoglobin (Hb) (if value >20 g/L below LLN or >10 g/L above ULN), lymphocytes (if value <0.5*LLN), neutrophils (if value <1 giga unit per liter [GI/L]) and platelets (if value <80 GI/L or >500 GI/L). Number of participants with hematology parameters of PCC at 'any visit post-Baseline' are presented.|Up to Week 26|Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.|||Participants|||Number
2559248|NCT02683746|Secondary|Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern (PCC)|Chemistry parameters for which PCC values were identified were alanine aminotransferase (ALT) (if value >3 * upper limit of normal [ULN]), albumin (if value >5 gram/liter [g/L] above ULN or below lower limit of normal [LLN]), alkaline phosphatase (alk.phosph.) (if value >3*ULN), aspartate aminotransferase (AST) (if value >3*ULN), total bilirubin (if value >1.5 ULN), calcium (if value <1.8 or >3.0 millimoles per liter [mmol/L]), carbon di oxide (CO2) (if value <16 or >40 mmol/L), creatinine (if value >159 micromoles per liter [µmol/L]), direct bilirubin (if value >1.35*ULN), gamma glutamyl transferase (GGT) (if value >3*ULN), potassium (if value >0.5 mmol/L below LLN and >1.0 mmol/L above ULN), protein (if value >15 g/L above ULN or below LLN), sodium (>5 mmol/L below LLN or above ULN), urate (if value >654 µmol/L) and urea (if value >2*ULN). Number of participants with chemistry parameters of PCC at 'any visit post-Baseline' are presented.|Up to Week 26|Safety Population. Only those participants present at 'any visit post-Baseline' are analyzed.|||Participants|||Number
2559249|NCT02683746|Secondary|Number of Participants With On-therapy Adverse Events (AEs) and Serious AEs (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function.|Up to Week 26|Safety Population comprised of all enrolled participants who received at least one dose of study treatment.|||Participnats|||Number
2559250|NCT02683746|Primary|Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26|Blood samples will be collected from participants at specific time points to evaluate HbA1c to monitor for potential hyperglycemia. The last measurement collected prior to the first dose of randomized study treatment was considered as Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The analysis was performed using a mixed-effect model with repeated measures (MMRM) method. The primary analysis will include all HbA1c values collected at scheduled visits from Week 4 up to Week 26. This will include values after hyperglycemia rescue and discontinuation from investigational product. Imputation under the non-inferiority null hypothesis for missing data will be incorporated.|Baseline and Week 26|Intent-To-Treat (ITT) Population comprised of all randomized participants who received at least one dose of study treatment and have a Baseline assessment.|||Percentage of total hemoglobin||Standard Error|Least Squares Mean
2559251|NCT02683707|Secondary|Patient Self-reported Pain|"Patient self report of pain using a visual analog scale (VAS). Scale ranges from 0 to 10 with 0 being No pain and 10 being Most severe pain."|2 hours||||units on a scale||Standard Deviation|Mean
2559252|NCT02683707|Secondary|Platelet Reactivity Using Light Transmission Aggregometry|Blood test of Platelet Cell Reactivity using Light Transmission Aggregometry (reported as percent of baseline aggregation in response to adenosine diphosphate stimulation)|Measured at 2 hours|Only the subgroup (n=70) of enrolled participants who required PCI and were loaded with ticagrelor had information on the primary endpoint|||percentage of baseline aggregation||Standard Deviation|Mean
2559253|NCT02683707|Secondary|Single Time-point Platelet Reactivity Using Verify Now|Blood test of Platelet Cell Reactivity using Verify Now (P2Y12 Reactivity Units)|Measured at 2 hours|Only the subgroup (n=70) of enrolled participants who required PCI and were loaded with ticagrelor had information on the primary endpoint|||PRUs||Standard Deviation|Mean
2559254|NCT02683707|Primary|Ticagrelor Pharmacokinetics|Area under the curve for Ticagrelor Absorption|Measured over 24 hours (at 0, 0.5, 1, 2, 4, and 24 hours)|Only the subgroup (n=70) of enrolled participants who required PCI and were loaded with ticagrelor had information on the primary endpoint|||ng*hr/mL||Standard Error|Mean
2559255|NCT02683668|Secondary|Multi−Breath Washout Test (MBW), Scond|After the treatment period the MBW parameters. Scond is a gas exchange measures, assessing convectional ventilation heterogeneity in peripheral conducting airways.|14 days||||kPa\l\s||Standard Deviation|Mean
2559256|NCT02683668|Secondary|Lung Function FEV1|After treatment period the lung function parameters FEV1|14 days||||liters||Standard Deviation|Mean
2559257|NCT02683668|Secondary|Sacin|After treatment Impulse Oscillometry parameter. Sacin is a gas exchange measures, assessing convectional ventilation heterogeneity in pre acinar/acinar airways.|14 days||||kPa\l\s||Standard Deviation|Mean
2560654|NCT02661256|Secondary|Silent Aspiration|The occurrence of barium below the level of the vocal folds (aspiration) with no occurrence of cough (silent). This is a measure of absence of a cough during aspiration (silent aspiration).|<5 seconds post swallow trigger||||Participants|||Count of Participants
2559259|NCT02683577|Primary|Assessment of Apparent Terminal Elimination Rate Constant (λz) for Telotristat Ethyl and LP-778902 (Active Metabolite)|Blood was sampled for the purpose of determining PK parameters for total telotristat ethyl and its active metabolite LP-778902 using a LC-MS/MS bioanalytical method. The method was selective, linear, precise and accurate within the range from 0.5 to 500 ng/mL for telotristat ethyl and from 2 to 2000 ng/mL for LP-778902. The LoQ for telotristat ethyl and its metabolite LP-778902 were 0.5 ng/mL and 2.0 ng/mL, respectively.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]). Only subjects with data available for analysis are reported.|||hour^-1||Geometric Coefficient of Variation|Geometric Mean
2559260|NCT02683577|Primary|Assessment of t1/2 for Telotristat Ethyl and LP-778902 (Active Metabolite)|Blood was sampled for the purpose of determining PK parameters for total telotristat ethyl and its active metabolite LP-778902 using a LC-MS/MS bioanalytical method. The method was selective, linear, precise and accurate within the range from 0.5 to 500 ng/mL for telotristat ethyl and from 2 to 2000 ng/mL for LP-778902. The LoQ for telotristat ethyl and its metabolite LP-778902 were 0.5 ng/mL and 2.0 ng/mL, respectively.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]). Only subjects with data available for analysis are reported.|||hour||Geometric Coefficient of Variation|Geometric Mean
2559261|NCT02683577|Primary|Assessment of AUC(0-inf) for LP-778902 (Active Metabolite) and Comparison Between Each HI Group and Healthy Control Group|Blood was sampled for the purpose of determining PK parameters for LP-778902 (active metabolite of telotristat ethyl) using a LC-MS/MS bioanalytical method. The method was selective, linear, precise and accurate within the range from 2 to 2000 ng/mL for LP-778902 and the LoQ was 2.0 ng/mL. Results were derived by non-compartmental analysis of the plasma concentration-time profiles. AUC(0-inf) was not determined when terminal half-life (t1/2) could not be determined over a time interval equal to at least 2 times t1/2 and/or the adjusted coefficient of determination value was inferior to 0.7 and/or extrapolated AUC was greater than 20%.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]). Only subjects with data available for analysis are reported.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2559262|NCT02683577|Primary|Assessment of AUC(0-tlast) for LP-778902 (Active Metabolite) and Comparison Between Each Hepatic Impairment Group and Healthy Control Group|Blood was sampled for the purpose of determining PK parameters for LP-778902 (active metabolite of telotristat ethyl) using a LC-MS/MS bioanalytical method. The method was selective, linear, precise and accurate within the range from 2 to 2000 ng/mL for LP-778902 and the LoQ was 2.0 ng/mL. Results were derived by non-compartmental analysis of the plasma concentration-time profiles.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]).|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2559263|NCT02683577|Primary|Assessment of Tmax for LP-778902 (Active Metabolite) and Comparison Between Each Hepatic Impairment Group and Healthy Control Group and Comparison Between Each Hepatic Impairment Group and Healthy Control Group|Blood was sampled for the purpose of determining PK parameters for LP-778902 (active metabolite of telotristat ethyl) using a LC-MS/MS bioanalytical method. The method was selective, linear, precise and accurate within the range from 2 to 2000 ng/mL for LP-778902 and the LoQ was 2.0 ng/mL. Results were derived by non-compartmental analysis of the plasma concentration-time profiles.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]).|||hour||Full Range|Median
2559264|NCT02683577|Primary|Assessment of Cmax for LP-778902 (Active Metabolite) and Comparison Between Each HI Group and Healthy Control Group|Blood was sampled for the purpose of determining PK parameters for LP-778902 (active metabolite of telotristat ethyl) using a LC-MS/MS bioanalytical method. The method was selective, linear, precise and accurate within the range from 2 to 2000 ng/mL for LP-778902 and the LoQ was 2.0 ng/mL. Results were derived by non-compartmental analysis of the plasma concentration-time profiles.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2559278|NCT02683174|Primary|Number of Ambulatory Patch Monitor Participants Having Significant Symptomatic Arrhythmia|"Significant arrhythmia will be defined as:~Non-symptomatic ventricular tachycardia < 30 seconds,~Symptomatic sinus bradycardia < 60 beats/minute (but >40 or less than 30 seconds),~Asymptomatic sinus bradycardia < 40 beats/minute,~Sick sinus syndrome with alternating sinus bradycardia and tachycardia,~Sinus pause > 3 seconds (but less than 6 seconds),~Symptomatic Mobitz type I atrioventricular heart block,~Junctional/idioventricular rhythm,~Symptomatic supraventricular tachycardia with rate > 100/minute,~Symptomatic atrial flutter/fibrillation with ventricular rate >100/min,~Symptomatic atrial flutter/fibrillation with ventricular rate <60/min~Arrhythmias will also be defined as symptomatic (i.e. concurrent light-headedness/dizziness, syncope/presyncope with arrhythmia) or asymptomatic."|90 days||||Participants|||Count of Participants
2559279|NCT02683161|Primary|Change in Smoking Status|Smoking abstinence is defined the change in number of self-reported cigarettes smoked per week|Assessed starting in week 2 of 12 weekly study visits||||Mean cigarettes per/day||Standard Deviation|Mean
2559265|NCT02683577|Primary|Assessment of Area Under the Plasma Concentration Time Curve From Time 0 to Infinity (AUC[0-inf]) for Telotristat Ethyl|Blood was sampled for the purpose of determining PK parameters for total telotristat ethyl using a LC-MS/MS bioanalytical method. The method was selective, linear, precise and accurate within the range from 0.5 to 500 ng/mL for telotristat ethyl and the LoQ was 0.5 ng/mL. Results were derived by non-compartmental analysis of the plasma concentration-time profiles. AUC(0-inf) was not determined when the apparent terminal elimination half-life (t1/2) could not be determined over a time interval equal to at least 2 times t1/2 and/or the adjusted coefficient of determination value was inferior to 0.7 and/or extrapolated AUC was greater than 20%.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]). Only subjects with data available for analysis are reported.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2559266|NCT02683577|Primary|Assessment of Area Under the Plasma Concentration Time Curve From 0 to Time t Corresponding to the Last Quantifiable Concentration (AUC[0-tlast]) for Telotristat Ethyl and Comparison Between Each HI Group and Healthy Control Group|Blood was sampled for the purpose of determining PK parameters for total telotristat ethyl using a LC-MS/MS bioanalytical method. The method was selective, linear, precise and accurate within the range from 0.5 to 500 ng/mL for telotristat ethyl and the LoQ was 0.5 ng/mL. Results were derived by non-compartmental analysis of the plasma concentration-time profiles.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]).|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2559267|NCT02683577|Primary|Assessment of Time to Maximum Observed Plasma Concentration (Tmax) for Telotristat Ethyl and Comparison Between Each HI Group and Healthy Control Group|Blood was sampled for the purpose of determining PK parameters for total telotristat ethyl using a LC-MS/MS bioanalytical method. The method was selective, linear, precise and accurate within the range from 0.5 to 500 ng/mL for telotristat ethyl and the LoQ was 0.5 ng/mL. Results were derived by non-compartmental analysis of the plasma concentration-time profiles.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 h post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]).|||hour||Full Range|Median
2559268|NCT02683577|Primary|Assessment of Maximum Observed Plasma Drug Concentration (Cmax) for Telotristat Ethyl and Comparison Between Each HI Group and Healthy Control Group|Blood was sampled for the purpose of determining pharmacokinetic (PK) parameters for total telotristat ethyl using a validated, specific, and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) bioanalytical method. The method was selective, linear, precise and accurate within the range from 0.5 to 500 nanograms per millilitre (ng/mL) for telotristat ethyl and the lower limit of quantification (LoQ) was 0.5 ng/mL. Results were derived by non-compartmental analysis of the plasma concentration-time profiles.|Blood samples were collected on Day 1 (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours [h] post-dose), Day 2 (24 h), Day 3 (48 h) and Day 4 (72 h).|The PK population (23 subjects overall) corresponded to all subjects who received at least one dose of study medication, without protocol violation affecting PK evaluation and who had a sufficient number of plasma concentrations to estimate the main PK parameters (Cmax, Tmax and AUC[0-tlast]).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2559269|NCT02683421|Secondary|Localization Intensity of Tc 99m Tilmanocept by Planar Imaging in Regions of Interest Relative to Background in All Dose Groups|Tc 99m tilmanocept localization intensity on planar imaging relative to localization intensity in corresponding background regions was calculated (percent of background) for each region of interest and averaged for each dose/disease group.|2-4 hours and 4-6 hours||||Percent difference from background||Standard Deviation|Mean
2559270|NCT02683421|Secondary|Dose-dependent Tc 99m Tilmanocept Localization Intensity by Planar and SPECT/CT Imaging|Tc 99m tilmanocept localization intensity on planar imaging was compared among dose/disease groups. Localization intensity was quantitatively analyzed by observing average voxel intensity in regions of interest, which were drawn over areas of increased uptake in the RA-affected joints.|2-4 hours and 4-6 hours||||Voxel Intensity||Standard Deviation|Mean
2559271|NCT02683421|Primary|Localization of Tc 99m Tilmanocept by Planar and SPECT/CT Imaging in Subjects With Active RA and Concordance With Swollen/Tender Joints|The primary endpoint was to compare the cumulative total of anatomical zones of active RA (which were clinically defined by a swollen/tender classification during the DAS28 joint count assessment performed at baseline) with Tc 99m tilmanocept localization observed at 2-3 hours and at 4-6 hours after administration on Day 1. Tc 99m tilmanocept localization is defined by accumulation of radioactivity at an intensity greater than background, which was qualitatively determined by the central reader's visual assessment of the acquired images .|Swollen/tender joints assessment at baseline and Tc 99m tilmanocept localization at 2-3 hours and 4-6 hours after administration on Day 1||||Joints|||Number
2559272|NCT02683174|Secondary|Number of Participants With All Cause Serious Outcome|"All cause serious outcome will be a composite of:~All cause death,~Major adverse cardiac events [MACE]~Myocardial infarction [25],~Significant arrhythmia [25],~Significant Structural Heart Disease [23],~Positive Electrophysiology Study Findings [25]~Permanent pacemaker or defibrillator placement,~Coronary artery bypass graft or coronary artery stent,~Cardiac valve surgery,~Elective cardioversion in the absence of objective evidence that tachyarrhythmia is responsible for the syncope,~Balloon-pump insertion,~Heart transplant,~Initiation of anti-arrhythmia medical therapy,~Ventricular assist device"|90 days||||Participants|||Count of Participants
2559273|NCT02683174|Secondary|Number of Participants With Significant Arrhythmia Requiring Referral.|Number of participants with significant underlying arrhythmic pathology on ambulatory patch monitoring requiring referral.|90 days||||Participants|||Count of Participants
2559274|NCT02683174|Secondary|Median Device Wear Time|Patch compliance described by median device wear time|14 days||||days||Inter-Quartile Range|Median
2559280|NCT02683109|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28|"This outcome measure presents COPD assessment test score on Day 28. The COPD Assessment Test™ is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health).~The CAT measurement on Visit 4 prior to the first dose of double-blind study drug was the baseline for CAT."|Day 28|FAS. One patient in the T 5/O 5 free combination group had missing data for the CAT questionnaire.|||Score on scale||Standard Error|Mean
2559281|NCT02683109|Secondary|Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment|"This outcome measure presents trough FVC after 28 days of treatment (measurement on Day 29).~The FVC measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement for FVC."|Day 29|FAS.|||Liter||Standard Error|Mean
2559282|NCT02683109|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment|"This outcome measure presents FEV1 after 28 days of treatment (measurement on Day 29). Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), and was measured at 24 hours (+/- 10 minutes) after trial medication administration at Visit 5.~The FEV1 measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement."|Day 29|Full Analysis Set (FAS): This patient set is nested within the TS and includes patients who had a baseline measurement and at least one post-baseline measurement for the primary endpoint.|||Liter||Standard Error|Mean
2559283|NCT02683083|Secondary|The Tumor Targeting Potential Will be Visually Scored on the Planar Total Body Scan|Cancer lesions above 3 cm will be visually interpreted by an experienced nuclear medicine physician. Lesions will be scored positive if CAM-H2 uptake in the lesion is higher than surrounding background.|1 day||||Participants|||Count of Participants
2559284|NCT02683083|Primary|Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0||1 day||||Participants|||Count of Participants
2559285|NCT02682823|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Among Participants With RA|"Ability to perform daily living activities was assessed across eight component sets including dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Twenty questions were scored on a 4-point Likert scale from 0 meaning without any difficulty to 3 meaning unable to do. The overall score was computed as the sum of domain scores divided by the number of domains answered. Therefore, the score range for HAQ-DI was the same as that of the individual questions, that is, from 0 to 3, where 0 indicates least difficulty and 3 indicates extreme difficulty. The mean change from baseline in HAQ-DI at each assessment was reported among participants with RA."|Days 0, 14, 28|"Safety Population; only participants with RA were included because the endpoint was not applicable to CGs and HCPs. Here, n refers to number evaluable for the specified assessment, respectively."|||units on a scale||Standard Deviation|Mean
2559286|NCT02682823|Secondary|Swollen Joint Count (SJC) Among Participants With RA|Sixty-six joints were assessed for swelling among participants with RA. The number of swollen joints at Baseline was reported.|Baseline (Day 0)|Safety Population; only participants with RA were included because the endpoint was not applicable to CGs and HCPs.|||swollen joints||Standard Deviation|Mean
2559287|NCT02682823|Secondary|Tender Joint Count (TJC) Among Participants With RA|Sixty-eight joints were assessed for tenderness among participants with RA. The number of tender joints at Baseline was reported.|Baseline (Day 0)|Safety Population; only participants with RA were included because the endpoint was not applicable to CGs and HCPs.|||tender joints||Standard Deviation|Mean
2559288|NCT02682823|Secondary|Percentage of Participants by Response to Device Satisfaction Questionnaire|"Device satisfaction was assessed using twelve questions on a categorical 5-point Likert scale, ranging from strongly agree to strongly disagree. Question (Q) 1 (felt the autoinjection was easy to use), Q2 (felt comfortable while using the autoinjector), Q3 (felt the autoinjector was easy to hold), Q4 (able to tell when injection had completed), Q5 (felt he/she can inject properly with the autoinjector), Q6 (felt he/she had control over the injection process), Q7 (felt confident that he/she injected successfully), Q8 (felt it is easy to dispose of the autoinjector), Q9 (autoinjector would help to manage his/her injection schedule), Q10 (liked the look/feel of the autoinjector), Q11 (would recommend the autoinjector to someone else who needed to inject), Q12 (would continue having injections with the autoinjector). The percentage of participants was reported by response at each assessment among participants with RA, CGs, and HCPs."|Days 0, 14, 28|"Safety Population. Here, n refers to number evaluable for the specified assessment, respectively."|||percentage of participants|||Number
2559289|NCT02682823|Secondary|Percentage of Participants by Response to Categorical Scale of Injection Pain Among Participants With RA|"Injection pain was assessed on a categorical 6-point Likert scale, ranging from no pain to severe and intolerable. The percentage of participants was reported by response at each assessment timepoint among participants with RA."|0 and 15 minutes after injection on Days 0, 14, 28|"Safety Population; only participants with RA were included because the endpoint was not applicable to CGs and HCPs. Here, n refers to number evaluable for the specified assessment, respectively."|||percentage of participants|||Number
2559290|NCT02682823|Secondary|Visual Analog Scale (VAS) Score for Injection Pain Among Participants With RA|"Injection pain was assessed on a continuous 100-millimeter (mm) VAS, where 0 mm represents no pain and 100 mm represents unbearable pain. The mean VAS response at each assessment timepoint was reported among participants with RA."|0 and 15 minutes after injection on Days 0, 14, 28|"Safety Population; only participants with RA were included because the endpoint was not applicable to CGs and HCPs. Here, n refers to number evaluable for the specified assessment, respectively."|||mm||Standard Deviation|Mean
2559302|NCT02682498|Primary|48 Hour Post-surgical Opioid Use|A comparison of group means between the control group and study group with regards to 48 hour opioid use.|48 hours||||morphine equivalents||Standard Deviation|Mean
2559303|NCT02682381|Secondary|Change From Baseline in Days Per Week of Parenteral Nutrition Intravenous (PN/IV) Support at Week 24|The number of days per week of PN/IV infusions were reported.|Baseline, Week 24|ITT population included all enrolled participants.|||Days per week (Days/week)||Standard Deviation|Mean
2559304|NCT02682381|Secondary|Change From Baseline in Hours Per Day of Parenteral Nutrition Intravenous (PN/IV) Support at Week 24|The mean duration of the PN/IV infusions in hours, on the days when PN/IV was administered was reported.|Baseline, Week 24|ITT population included all enrolled participants.|||Hours per day (hour/day)||Standard Deviation|Mean
2559291|NCT02682823|Secondary|Percentage of Participants Who Successfully Performed Ancillary Tasks During First and Second Unassisted Use|Ancillary tasks included those tasks where the potential harm resulting from use error would be minor in severity, or the resultant harms were estimated to occur at sufficiently low levels. Ancillary tasks included the following: wash hands; clean the injection site with alcohol swab; wait for the alcohol to dry; dispose of the autoinjector cap; inspect full dose delivered after use; dispose of the autoinjector; and treatment of injection site after injection. The percentage of participants who succesffully performed ancillary tasks during the first (Day 14) and second unassisted use (Day 28) was reported.|Days 14, 28|"Safety Population; only those who performed the administration task(s) were included because the endpoint was not applicable to non-injecting participants. Here, n refers to number evaluable for the specified assessment, respectively."|||percentage of participants|||Number
2559292|NCT02682823|Primary|Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During Second Unassisted Use|Safety-critical tasks included those tasks where errors would have a reasonably foreseeable potential for clinical impact/harm, potentially resulting in direct physical injury to the user and/or conditions that require medical intervention. Safety-critical tasks included the following: release activation button; check the expiry date; inspect device prior to use; and inspect medication prior to use. Essential tasks included those essential to the execution of the injection. Essential tasks included the following: open the carton, remove the device and associated documents; remove cap; start an injection by depressing the needle-shield at the injection site and pressing the activation button; and hold the autoinjector until the complete dose has been delivered. The percentage of participants who successfully performed safety-critical and essential tasks during the second unassisted use (Day 28) was reported.|Day 28|Safety Population; only those who performed the administration task(s) on Day 28 were included because the endpoint was not applicable to non-injecting participants.|||percentage of participants|||Number
2559293|NCT02682823|Primary|Percentage of Participants Who Successfully Performed Safety-Critical and Essential Tasks During First Unassisted Use|Safety-critical tasks included those tasks where errors would have a reasonably foreseeable potential for clinical impact/harm, potentially resulting in direct physical injury to the user and/or conditions that require medical intervention. Safety-critical tasks included the following: release activation button; check the expiry date; inspect device prior to use; and inspect medication prior to use. Essential tasks included those essential to the execution of the injection. Essential tasks included the following: open the carton, remove the device and associated documents; remove cap; start an injection by depressing the needle-shield at the injection site and pressing the activation button; and hold the autoinjector until the complete dose has been delivered. The percentage of participants who successfully performed safety-critical and essential tasks during the first unassisted use (Day 14) was reported.|Day 14|"Safety Population; only those who performed the administration task(s) on Day 14 were included because the endpoint was not applicable to non-injecting participants. Here, n refers to number evaluable for the specified assessment, respectively."|||percentage of participants|||Number
2559294|NCT02682602|Primary|Magnitude of Hip Separation During Primary Toe Off|"Negative values indicate hip compression, position values indicate hip separation. All Diseased Hip subjects were re-analyzed approximately 2 years postoperatively to yield the Implanted Hip group."|Approximately 2 years postoperatively.|"All Diseased Hip subjects were re-analyzed approximately 2 years postoperatively to yield the Implanted Hip group."|||mm||Standard Deviation|Mean
2559295|NCT02682602|Primary|Magnitude of Hip Separation During Contra-lateral Heel Strike|"Negative values indicate hip compression, position values indicate hip separation. All Diseased Hip subjects were re-analyzed approximately 2 years postoperatively to yield the Implanted Hip group."|Approximately 2 years postoperatively.|"All Diseased Hip subjects were re-analyzed approximately 2 years postoperatively to yield the Implanted Hip group."|||mm||Standard Deviation|Mean
2559296|NCT02682602|Primary|Magnitude of Hip Separation During Contra-lateral Toe Off|"Negative values indicate hip compression, position values indicate hip separation. All Diseased Hip subjects were re-analyzed approximately 2 years postoperatively to yield the Implanted Hip group."|Approximately 2 years postoperatively.|"All Diseased Hip subjects were re-analyzed approximately 2 years postoperatively to yield the Implanted Hip group."|||mm||Standard Deviation|Mean
2559297|NCT02682602|Primary|Magnitude of Hip Separation During Primary Heel Strike|"Negative values indicate hip compression, position values indicate hip separation. All Diseased Hip subjects were re-analyzed approximately 2 years postoperatively to yield the Implanted Hip group."|Approximately 2 years postoperatively.|"All Diseased Hip subjects were re-analyzed approximately 2 years postoperatively to yield the Implanted Hip group."|||mm||Standard Deviation|Mean
2559298|NCT02682498|Secondary|Post-operative Complications|Examining the post-operative complication in comparison of standard knee injection post-operatively.|Up to 1 month|The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.|||complications|||Number
2559299|NCT02682498|Secondary|Average Daily Patient Pain Score|Examining the average daily patient pain score in comparison of standard knee injection post-operatively. The measure is the Visual-Analog-Scale (VAS) for subjective pain reporting. The minimum 0 (no pain) and the maximum is 10 (worst pain imagineable). There is only one measure in the scale (i.e. there are no subscales). Lower scores on the VAS scale equate to less pain and are therefore desirable.|Up to 48 hours|The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.|||Visual Analog Scale Rating||Inter-Quartile Range|Mean
2559300|NCT02682498|Secondary|Average Daily Opioid Use During Admission|Opioid use will be monitored daily from the time of admission in comparison of standard knee injection post-operatively.|Up to 48 hours|The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.|||Total Morphine Equivalents||Inter-Quartile Range|Mean
2559301|NCT02682498|Secondary|Recovery Room Opioid Use|Post anesthesia care unit (recovery room) opioid use in total mg morphine IV equivalent in comparison of standard knee injection post-operatively.|Up to 48 hours|The vast majority of the patients had been discharged by 72 hours post-op, making this outcome low-powered and not useful. Because of this we used the 48 hour pain measurement.|||Total morphine equivalents||Inter-Quartile Range|Median
2559305|NCT02682381|Secondary|Change From Baseline in Participants' Stool Consistency at Week 28|Stool consistency was assessed by typical stool form based on Bristol Stool Form Scale: 1 - Separate hard lumps, hard to pass, 2 - Sausage-shaped, but lumpy, 3 - Like a sausage but with cracks on the surface, 4 - Like a sausage or snake, smooth and soft, 5 - Soft blobs with clear-cut edges, 6 - Fluffy pieces with ragged edges, a mushy stool, 7 - Watery, no solid pieces, entirely liquid.|Baseline, Week 28|Safety analysis population with number of participants evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
2559306|NCT02682381|Secondary|Change From Baseline in Body Mass Index (BMI) Z-score at Week 28|BMI z-score is a measure of relative BMI adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|Baseline, Week 28|Safety analysis population with number of participants evaluable for this outcome measure.|||Z-score||Standard Deviation|Mean
2559307|NCT02682381|Secondary|Change From Baseline in Head Circumference Z-score at Week 28|Head circumference z-score is a measure of relative head circumference adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. Head circumference was collected only for participants of less than or equal to (<=) 36 months of age at the time of measurement.|Baseline, Week 28|Safety analysis population with number of participants evaluable for this outcome measure.|||Z-score||Standard Deviation|Mean
2559308|NCT02682381|Secondary|Change From Baseline in Body Height Z-score at Week 28|Body height z-score is a measure of relative height adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|Baseline, Week 28|Safety analysis population with number of participants evaluable for this outcome measure.|||Z-score||Standard Deviation|Mean
2559309|NCT02682381|Secondary|Change From Baseline in Body Weight Z-score at Week 28|Body weight z-score is a measure of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|Baseline, Week 28|Safety analysis population included all participants who received at least 1 dose of teduglutide and had undergone at least 1 post-baseline safety assessment in teduglutide treatment group or participants who had undergone at least 1 post-baseline safety assessment in standard of care treatment group.|||Z-score||Standard Deviation|Mean
2559310|NCT02682381|Secondary|Change From Week 24 in Enteral Nutrition Caloric Intake at Week 28|Enteral nutrition was defined as specialized formula taken orally or by tube feeding, and excluded table foods and other fluids. Change in enteral nutrition caloric intake was reported.|Week 24, Week 28|ITT population included all enrolled participants.|||Kilocalorie per kilogram per day||Standard Deviation|Mean
2559311|NCT02682381|Secondary|Change From Week 24 in Enteral Nutrition Volume at Week 28|Enteral nutrition was defined as specialized formula taken orally or by tube feeding, and excluded table foods and other fluids. Change in enteral nutrition volume was reported.|Week 24, Week 28|ITT population included all enrolled participants.|||Milliliter per kilogram per day||Standard Deviation|Mean
2559312|NCT02682381|Secondary|Change From Week 24 in Plasma Citrulline Levels at Week 28|Change in plasma citrulline level was reported.|Week 24, Week 28|ITT population with number of participants evaluable for this outcome measure.|||Micromoles per liter||Standard Deviation|Mean
2559313|NCT02682381|Secondary|Change From Week 24 in Parenteral Nutrition Intravenous (PN/IV) Caloric Intake at Week 28|Change in PN/IV caloric intake was reported.|Week 24, Week 28|ITT population included all enrolled participants.|||Kilocalorie per kilogram per day||Standard Deviation|Mean
2559314|NCT02682381|Secondary|Change From Week 24 in Parenteral Nutrition Intravenous (PN/IV) Volume at Week 28|Change in PN/IV volume was reported.|Week 24, Week 28|ITT population included all enrolled participants.|||Milliliter per kilogram per day||Standard Deviation|Mean
2559315|NCT02682381|Secondary|Change From Baseline in Enteral Nutrition Caloric Intake at Week 24|Enteral nutrition was defined as specialized formula taken orally or by tube feeding, and excluded table foods and other fluids. Change in enteral nutrition caloric intake was reported.|Baseline, Week 24|ITT population included all enrolled participants.|||Kilocalorie per kilogram per day||Standard Deviation|Mean
2559316|NCT02682381|Secondary|Change From Baseline in Enteral Nutrition Volume at Week 24|Enteral nutrition was defined as specialized formula taken orally or by tube feeding, and excluded table foods and other fluids. Change in enteral nutrition volume was reported.|Baseline, Week 24|ITT population included all enrolled participants.|||Milliliter per kilogram per day||Standard Deviation|Mean
2559317|NCT02682381|Secondary|Change From Baseline in Plasma Citrulline Levels at Week 24|Plasma citrulline level was reported.|Baseline, Week 24|ITT population with number of participants evaluable for this outcome measure.|||Micromoles per liter||Standard Deviation|Mean
2559318|NCT02682381|Secondary|Change From Baseline in Parenteral Nutrition Intravenous (PN/IV) Caloric Intake at Week 24|Change in PN/IV caloric intake was reported based on the participant diary and the investigator prescribed data.|Baseline, Week 24|ITT population included all enrolled participants.|||Kilocalories per kilogram per day||Standard Deviation|Mean
2559319|NCT02682381|Secondary|Change From Baseline in Parenteral Nutrition Intravenous (PN/IV) Volume at Week 24|Change in PN/IV volume was reported based on the participant diary and the investigator prescribed data.|Baseline, Week 24|ITT population included all enrolled participants.|||Milliliters per kilogram per day||Standard Deviation|Mean
2559320|NCT02682381|Secondary|Number of Participants Who Were Completely Weaned Off Parenteral Nutrition Intravenous (PN/IV) Support at Week 24|A participant was considered to have achieved independence from PN/IV support (completely weaned off PN/IV) if the investigator prescribed no PN/IV at EOT and there was no use of PN/IV recorded in the participant diary during the week prior to EOT.|Week 24|ITT population included all enrolled participants.|||Participants|||Count of Participants
2559321|NCT02682381|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs that started or worsened on or after the date of first dose for treatment groups and those that started or worsened on or after the baseline visit for standard of care group.|From start of study treatment up to 28 weeks|Safety analysis population included all participants who received at least 1 dose of teduglutide and had undergone at least 1 post-baseline safety assessment in teduglutide treatment group or participants who had undergone at least 1 post-baseline safety assessment in standard of care treatment group.|||Participants|||Count of Participants
2559322|NCT02682381|Primary|Number of Participants Who Achieved at Least a 20 Percent (%) Reduction in Weight-Normalized Average Daily Parenteral Nutrition Intravenous (PN/IV) Volume at Week 24|Reduction in weight-normalized PN/IV volume was performed using both participant diary and investigator prescribed data. Number of participants who achieved at least a 20% reduction in weight-normalized PN/IV volume between the baseline and week 24/EOT visit were reported.|Baseline through Week 24|ITT population included all enrolled participants.|||Participants|||Count of Participants
2559323|NCT02682069|Primary|Positive Predictive Value (PPV) - Ability of Fluorescence Imaging With the MolecuLight i:X to Predict Presence of Bacterial Loads of 104 CFU/g and Greater|PPV reflects the probability that a region of red fluorescence within or around a wound will contain bacteria. Meaning the number cases where qPCR analysis of wound tissue biopsies from red fluorescent region showed to have pathogen load ≥ 104 CFU/g divided by the total number of cases where red florescence was observed in the wound multiplied by 100,|Baseline||||Percentage of PPV|||Number
2559324|NCT02682056|Secondary|Pain Level Assessed by Pain Visual Analog Scale (VAS)|Participants completed a Visual Analog Scale (VAS) to report the level of pain they felt regarding each method of sample collection. Participants marked on a line scale (between no pain and worst pain ever) to indicate pain level when a sample is collected. The range is from 0-100 mm with 0 mm indicating no pain and 100 mm indicating the most extreme pain.|Baseline ( Hour 1), Hour 4||||units on a scale||Standard Deviation|Mean
2559325|NCT02682056|Secondary|Apprehension Level Assessed by Apprehension Visual Analog Scale (VAS)|Participants completed a Visual Analog Scale (VAS) to report the level of apprehension they felt regarding each method of sample collection. Participants will mark on a line scale (between not afraid and very afraid) to indicate fear level when a sample is collected. The range is from 0-100 mm with 0 mm indicating no apprehension and 100 mm indicating the most apprehension.|Baseline ( Hour 1), Hour 4||||units on a scale||Standard Deviation|Mean
2559326|NCT02682056|Primary|Glucose Level|Participants had their glucose levels tested through three different methods. Interstitial glucose levels was assessed using a microneedles patch. Blood glucose levels were collected via the lancet and intravenous (IV) collection methods.|Baseline (Hour 1), Hour 2, Hour 3, Hour 4||||mg/dL||Standard Deviation|Mean
2559327|NCT02681757|Secondary|Presence of Yeast Infection in Burn Wound|Subject will be evaluated every 3-7 days from date of randomization for up to 21 days (End of Study) for clinically observed evidence of yeast infection from visible wound inspection at time of dressing change, i.e.: foul yeast odor, red erythematous rash.|Up to 21 days|The unit of observation is a single burn, not an individual patient. This outcome is number of yeast infections per burn dressing group.|||burns|Burns||Number
2559328|NCT02681757|Secondary|Evaluation of Pain Level|"Subject will be evaluated at first post-operative follow up visit ranging from date of surgery up to 21 days (End of Study) for level of pain at time of dressing change based on FLACC scale and calculated per Nurse and parent perceived level of patient pain. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2."|Up to 21 days from date of surgery||||Participants|||Count of Participants
2559329|NCT02681757|Primary|Change in Wound Appearance From Initial Injury Until Wound Healed|Burn will be evaluated every 3-7 days from date of randomization for up to 21 days (End of Study) after application of Mepitel Ag or triple antibiotic ointment impregnated Adaptic gauze to determine if the burn healed or not.|Up to 21 days|Some participants had multiple burns. We investigated all burns.|||Burns|Burns||Count of Units
2559330|NCT02681510|Secondary|Number of Participants Who Reported Quitting at the End of Treatment|Self-reported Quit Rate at End of Treatment (12 Weeks); assessed as no smoking in the 7 days prior to the Week 12 follow-up call|Week 12|All study participants (N=36)|||Participants|||Count of Participants
2559331|NCT02681510|Secondary|Participant Satisfaction With Medications' Ability to Help Participant Quit Smoking|Participant Satisfaction with Medications' Ability to Help Participant Quit Smoking assessed on a 1-10 Likert Scale (higher value=greater satisfaction)|Week 12|All study participants (N=36)|||units on a scale||Standard Deviation|Mean
2559332|NCT02681510|Secondary|Participant Satisfaction With Medications' Ability to Control Withdrawal Symptoms|Satisfaction with Medications' Ability to Control Withdrawal Symptoms assessed on a 1-10 Likert Scale (higher value=greater satisfaction)|Week 12||||units on a scale||Standard Deviation|Mean
2559333|NCT02681510|Primary|Number of Participants With Adverse Events|Assess adverse event rates in relation to participant ability to continue use of all 3 medications throughout the treatment period|12 weeks|All study participants (N=36)|||Participants|||Count of Participants
2559334|NCT02681458|Primary|The Prevalence of Superficial and Cutaneous Fungal Infections Among Drug and Non-Drug Users||up to two months||||participants|||Number
2559335|NCT02681172|Secondary|Number of Subjects Who Refused Lumbar Puncture.||Visit 1 (baseline evaluation)||||Participants|||Count of Participants
2559336|NCT02681172|Secondary|Number of Subjects With Available CSF Analysis But Results Considered as Non-contributory by the Clinician|Non-contributory CSF results (ambiguous CSF result, CSF result inconsistent with clinical information, uninterpretable CSF result for technical reasons)|Visit 1 (baseline evaluation)||||Participants|||Count of Participants
2559337|NCT02681172|Secondary|Number of Subjects With Contraindicated or Failed Lumbar Puncture|Number of subjects with contraindicated or failed LP (anticoagulant therapy, thrombocytopenia, lumbar puncture failed, spinal problems)|Visit 1 (baseline evaluation)||||Participants|||Count of Participants
2559340|NCT02681172|Secondary|Number of Participants With a Change of Management Plan Comparing Pre- and Post-scan Outcomes|For all subjects, concomitant medications were reported and any change of the management plan (e.g. new medications initiated, medications withdrawn, additional diagnostic tests ordered, referred to another specialist) was noted.|Visit 1 (baseline evaluation) and Visit 3 (up to 3 months later)|All subjects who received any amount of florbetaben were included in the Safety analysis set.|||Participants|||Count of Participants
2559341|NCT02681172|Secondary|Number of Subjects With Improved Level of Physician Confidence in Diagnosis at Visit 3|"The Physician's diagnostic confidence was rated on a five-point Likert scale before and after FBB PET scan. Likert scales consisted of the categories: very weak, weak, moderate, high, and very high."|Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later)||||Participants|||Count of Participants
2559342|NCT02681172|Primary|Number of Participants With a Change of Diagnosis Comparing Pre- and Post-scan Outcomes|The Physician's diagnosis was assessed before and after FBB PET scan. The initial Physician's diagnosis was collected before the PET scan, at Visit 1, based on key diagnostic results of current or previous workup. After the PET scan, the final Physician's diagnosis was collected at Visit 3, based on the amyloid PET scan results.|Visit 1 (baseline evaluation) and Visit 3 (up to 6 months later)|All subjects who received any amount of florbetaben were included in the Safety analysis set|||Participants|||Count of Participants
2559343|NCT02681094|Secondary|Change in Total Body Weight at 24 Weeks|To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to saxagliptin 5 mg on total body weight after 24 weeks. Results were presented for the modified full analysis set.|Baseline and week 24|FAS: All randomized participants who took at least one dose of the study medication and had a baseline value for HbA1c. Analysis of the FAS was based on the randomized treatment. The modified FAS included all participants from FAS with the exception of participants from one site (excluded due to serious GCP violations).|||Kilograms (Kg)||Standard Error|Least Squares Mean
2559344|NCT02681094|Secondary|Change in Fasting Plasma Glucose at 24 Weeks|To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5mg to either agent individually on fasting plasma glucose after 24 weeks. Results were presented for the modified full analysis set.|Baseline and week 24|FAS: All randomized participants who took at least one dose of the study medication and had a baseline value for HbA1c. Analysis of the FAS was based on the randomized treatment. The modified FAS included all participants from FAS with the exception of participants from one site (excluded due to serious GCP violations).|||Milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2559345|NCT02681094|Secondary|Proportion of Participants Achieving HbA1c <7.0% at 24 Weeks|To demonstrate the effect of the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually on proportion of participants achieving therapeutic glycaemic response after 24 weeks. Therapeutic glycaemic response was defined as an HbA1c value at Week 24 <7.0% irrespective of whether participant received rescue medication. Risk difference for each treatment was calculated as adjusted response rate. Participants who did not had an HbA1c measurement at Week 24 were regarded as non-responders. Results were presented for the modified full analysis set.|Baseline and week 24|FAS: All randomized participants who took at least one dose of the study medication and had a baseline value for HbA1c. Analysis of the FAS was based on the randomized treatment. The modified FAS included all participants from FAS with the exception of participants from one site (excluded due to serious GCP violations).|||Participants|||Number
2559346|NCT02681094|Primary|Change From Baseline in HbA1c at Week 24|"To demonstrate the superiority of the change from baseline HbA1c achieved with the co-administered saxagliptin 5 mg and dapagliflozin 5 mg to either agent individually after 24 weeks. Results were presented for the modified full analysis set.~Note: Baseline was defined as the last assessment on or prior to the date of the first dose of the study medication."|Baseline and week 24|FAS: All randomized participants who took at least one dose of the study medication and had a baseline value for HbA1c. Analysis of the FAS was based on the randomized treatment. The modified FAS included all participants from FAS with the exception of participants from one site (excluded due to serious GCP violations).|||Percentage (%)||Standard Error|Least Squares Mean
2559347|NCT02680847|Secondary|Number of Participants With Laboratory (Lab) Abnormalities (Hematology and Chemistry)|Following parameters were analyzed for hematologic laboratory tests: hemoglobin, hematocrit, red blood cells, mean corpuscular volume, platelets, white blood cells, lymphocytes (absolute & %), neutrophils (absolute & %), basophils (absolute & %), eosinophils (absolute &%), monocytes (absolute & %). Following parameters were analyzed for chemical laboratory tests: bilirubin,aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase, protein(total), albumin,blood urea nitrogen, creatinine, cholesterol, sodium, potassium,chloride, calcium, phosphate, bicarbonate, glucose, creatine kinase. None of the lab abnormalities were clinically significant.|Baseline up to Day 77|The laboratory data analysis set included only those participants who had post baseline lab results.|||Participants|||Count of Participants
2559348|NCT02680847|Secondary|Number of Participants With Maximum Changes in Vital Signs (Blood Pressure, Heart Rate, Respiratory Rate) Meeting Categorical Summarization Criteria|Following parameters were analyzed for examinations of vital signs: resting systolic and diastolic blood pressure, heart rate, and respiratory rate. In this study, there were only participants meeting the maximum decrease from baseline in systolic blood pressure (SBP) >= 30 mmHg and diastolic blood pressure (DBP) >=20 mmHg criteria. None of the vital sign changes were clinically significant.|Baseline up to Day 58|The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02.|||Participants|||Count of Participants
2559349|NCT02680847|Secondary|Systemic Exposure Levels of the Metabolites of Oxycodone (Oxymorphone and Noroxycodone), Naltrexone, and 6-β-naltrexol.|Oxymorphone and noroxycodone are major metabolites of Oxycodone and 6-β-naltrexol is the major metabolite of naltrexol.|Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase|The PK samples were collected but not analyzed and discarded due to early termination of the study.||||||
2559350|NCT02680847|Secondary|Apparent Volume of Distribution (Vz/F) of Oxycodone|ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.|Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase|The PK samples were collected but not analyzed and discarded due to early termination of the study.||||||
2559351|NCT02680847|Primary|Number of Participants With Clinical Opiate Withdrawal Scale (COWS)|The COWS contains 11 common opiate withdrawal signs or symptoms rated by the clinician.The summed score of the 11 items is used to assess a subject's level of withdrawal. A subject assessed with a COWS score>= 13 was treated for opiate withdrawal signs and symptoms according to the investigator's medical judgment. The total COWS score ranges from 0 to 48. Higher scores indicate worse outcome. Different score ranges represent different severities of withdrawal: no withdrawal (<5), mild (5-12), moderate (13-24), moderately severe (25-36), and severe (>36)|Screening, Day 1, Titration Phase: Weeks 1,2,3,4; end of titration phase; Maintenance phase: Weeks 2, 4; early termination at titration phase, end of maintenance phase.|The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02.|||Participants|||Count of Participants
2559352|NCT02680847|Primary|Number of Participants With All-causality and Treatment-related Serious Adverse Events (SAEs)|An SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. All-causality SAEs refer to any SAE occurrence which needed not necessarily have a causal relationship with the treatment or usage. Treatment-related SAEs refer to SAEs that have a causal relationship with the treatment or usage.|Baseline up to Day 63|The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02.|||Participants|||Count of Participants
2559353|NCT02680847|Primary|Number of All-causality and Treatment-related AEs, by Intensity|An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. All-causality AEs refer to any AE occurrence which needed not necessarily have a causal relationship with the treatment or usage. Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage. The majority of AEs were of mild to moderate severity.|Baseline up to Day 63|The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02.|||Events|||Number
2559354|NCT02680847|Primary|Number of Participants With All-causality and Treatment-related Adverse Events (AEs)|An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. All-causality AEs refer to any AE occurrence which needed not necessarily have a causal relationship with the treatment or usage. Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage. The majority of AEs were of mild to moderate severity.|Baseline up to Day 63|The safety population consisted of all subjects who participated in the treatment period and received at least 1 dose of ALO-02.|||Participants|||Count of Participants
2559355|NCT02680847|Primary|Apparent Oral Clearance (CL/F) of Oxycodone|ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.|Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase|The PK samples were collected but not analyzed and discarded due to early termination of the study.||||||
2559356|NCT02680847|Primary|Average Steady-state Concentration (Css, av) of Oxycodone|ALO-02 capsules consist of controlled-release pellets containing oxycodone hydrochloride (HCl) and naltrexone HCl. Oxycodone is a main component of this product.|Visit 4 (Day 21,28,35 or 42) or Visit 5 if not collected at Visit 4 (early termination or end of study, which occurred on Day 35,42,49 or 56) in Maintenance Phase|The PK samples were collected but not analyzed and discarded due to early termination of the study.||||||
2559357|NCT02680834|Secondary|Outpatient Costs|Assessment of the effect of the Actitouch compared to a standard regimen of multi-layer bandaging on mean total outpatient costs per subject.|Changes from Baseline to 16 weeks|Per Protocol Population (Patients randomized who received treatment and had baseline and end of study measures).|||Dollars||Standard Deviation|Mean
2559358|NCT02680834|Secondary|Patient-Reported Quality of Life|The Charing Cross Venous Ulcer Questionnaire assesses the patients' perception of their health when venous ulceration is present. All items are scored so that a lower score defines a more favorable health state (a greater reduction is associated with improved quality of life). In addition, each item is scored using a 1 to 5 range so that the lowest and highest possible scores are 0 and 100, respectively.|Changes from Baseline to 16 weeks|Per Protocol Population (Patients randomized who received treatment and had both Baseline and end of study measures).|||Change in total score||Standard Deviation|Mean
2559359|NCT02680834|Primary|Percentage of VLU Area Reduction|Percentage of ulcer area reduction in the target VLU during the 16 week treatment period calculated by wound imaging software.|Changes from Baseline to 16 weeks|*Per Protocol Population (MITT patients who were randomized, received treatment, and did not exit the study early).|||percentage change||Standard Deviation|Mean
2559360|NCT02680756|Other Pre-specified|Number of Patients With Treatment-emergent Serious Adverse Events (SAEs)|Number of Patients with Treatment-emergent Serious Adverse Events (SAEs).|Baseline to Week 52|3 subjects were randomised to IV iron but were given ferric maltol in error.|||Participants|||Count of Participants
2559361|NCT02680756|Other Pre-specified|Number of Patients With Treatment-emergent Adverse Events (AEs)|Number of Patients with Treatment-emergent Adverse Events (AEs).|Baseline to Week 52|3 subjects were randomised to IV iron but were given ferric maltol in error.|||Participants|||Count of Participants
2559382|NCT02680665|Secondary|Overall Clinical Response Rate|"Clinical response rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with its 2-sided 95% CI. Clinical response of AMEPAROMO capsules was assessed as effective, not effective, or indeterminate by the physician based on the clinical course at the end of the observation period or at the time of treatment discontinuation."|10 days at maximum|The clinical response analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at the end of the observation period or at the time of treatment discontinuation. Participants with non-target disease (9) and participants who assessed as indeterminate at the final observation (6) were excluded.|||Percentage of Participants||95% Confidence Interval|Number
2559362|NCT02680756|Other Pre-specified|Change From Baseline Physical Component and Mental Component Score|"A multipurpose, proprietary health survey with 36 questions. It was constructed to survey health status in the Medical Outcomes Study and designed for use in clinical practice and research & general population surveys.~The SF-36 includes one multi-item scale that assesses 8 health components:~Physical Functioning Component; Social Functioning Component; Role-Physical Component; Bodily Pain Component; Mental Health Component; Role-Emotional Component; Vitality Component; & General Health Component.~These 8 health component scales can be further summarised into 2 summary scores, the Mental Component Score & the Physical Component Score where higher values mean a better outcome.~Both scales range from 0 to 100, where higher scores indicate better health status.~The survey will be administered at study visits as indicated in the schedule of assessments, commencing pre-randomization at Visit 2. The survey will be completed by the subjects in their native language."|Baseline to Week 52 (LOCF)||||score on a scale||Standard Deviation|Mean
2559363|NCT02680756|Secondary|Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 4|Number of subjects with baseline hemoglobin <9.5g/dL that achieve an increase in hemoglobin concentration of ≥2 g/dL at Week 4|Baseline to Week 4|Not all subjects were tested.|||Participants|||Count of Participants
2559364|NCT02680756|Secondary|Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 4|Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 4.|Baseline to Week 4|Total patient population for intravenous administration included subjects who did not attend Week 4 visit, therefore, the number is less than 93.|||Participants|||Count of Participants
2559365|NCT02680756|Secondary|Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 4|Normal limits defined as women with hemoglobin concentration greater than 12 g/dL and men with hemoglobin concentration greater than 13 g/dL.|Baseline to Week 4|Not all subjects were tested.|||Participants|||Count of Participants
2559366|NCT02680756|Secondary|Number of Subjects With Hb Concentration Within Normal Limits at Week 4|Normal limits defined as women with hemoglobin concentration greater than 12 g/dL and men with hemoglobin concentration greater than 13 g/dL.|Baseline to Week 4|Total patient population for intravenous administration included subjects who did not attend Week 4 visit, therefore, the number is less than 93.|||Participants|||Count of Participants
2559367|NCT02680756|Secondary|Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 4|Number of subjects with baseline hemoglobin <9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 4.|Baseline to Week 4|Not all subjects were tested.|||Participants|||Count of Participants
2559368|NCT02680756|Secondary|Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 4|Number of subjects who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at Week 4.|Baseline to Week 4|Total patient population for intravenous administration included subjects who did not attend Week 4 visit, therefore, the number is less than 93.|||Participants|||Count of Participants
2559369|NCT02680756|Secondary|Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 12|Number of subjects with baseline hemoglobin <9.5g/dL that achieve an increase in hemoglobin concentration of ≥2 g/dL at Week 12.|Baseline to Week 12|Not all subjects were tested.|||Participants|||Count of Participants
2559370|NCT02680756|Secondary|Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥2.0 g/dL at Week 12|Number of subjects who experience a change from baseline in hemoglobin concentration ≥2.0 g/dL at Week 12.|Baseline to Week 12||||Participants|||Count of Participants
2559371|NCT02680756|Secondary|Change in Hb Concentration From Baseline to Week 4 in Subjects With a Baseline Hb <9.5 g/dL|Change in hemoglobin concentration from baseline to Week 4 in subjects with a baseline hemoglobin <9.5 g/dL.|Baseline to Week 4|Not all subjects were tested.|||Participants|||Count of Participants
2559372|NCT02680756|Secondary|Change in Hb Concentration From Baseline to Week 4|Change in hemoglobin concentration from baseline to Week 4.|Baseline to Week 4||||g/dL||Standard Deviation|Mean
2559373|NCT02680756|Secondary|Long Term Efficacy Endpoints i.e. Proportion of Subjects Who Are Non-anaemic at 6 and 12 Months; Normalization of Ferritin Levels at 6 and 12 Months|Long term efficacy endpoints i.e. proportion of subjects who are non-anaemic at 6 and 12 months; normalization of ferritin levels at 6 and 12 months.|Baseline to Month 6 and Month 12|Not all subjects were tested.|||Participants|||Count of Participants
2559374|NCT02680756|Secondary|Number of Subjects With Baseline Hb Concentration <9.5 g/dL That is Within Normal Limits at Week 12|Normal limits defined as women with hemoglobin concentration greater than 12 g/dL and men with hemoglobin concentration greater than 13 g/dL.|Baseline to Week 12||||Participants|||Count of Participants
2559375|NCT02680756|Secondary|Number of Subjects With Hb Concentration Within Normal Limits at Week 12|Normal limits defined as women with hemoglobin concentration greater than 12 g/dL and men with hemoglobin concentration greater than 13 g/dL.|Baseline to Week 12||||Participants|||Count of Participants
2559376|NCT02680756|Secondary|Number of Subjects With Baseline Hb <9.5g/dL That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 12|Number of subjects with baseline hemoglobin <9.5g/dL that achieve an increase in hemoglobin concentration of ≥1 g/dL at Week 12.|Baseline to Week 12|Not all subjects were tested.|||Participants|||Count of Participants
2559377|NCT02680756|Secondary|Number of Subjects Who Experience a Change From Baseline in Hb Concentration ≥1.0 g/dL at Week 12|Number of subjects who experience a change from baseline in hemoglobin concentration ≥1.0 g/dL at Week 12.|Baseline to Week 12||||Participants|||Count of Participants
2559378|NCT02680756|Secondary|Change in Hb Concentration From Baseline to Week 12 in Subjects With a Baseline Hb <9.5 g/dL|Change in hemoglobin concentration from baseline to Week 12 in subjects with a baseline hemoglobin <9.5 g/dL.|Baseline to Week 12||||g/dL||Standard Deviation|Mean
2559379|NCT02680756|Secondary|Change in Hb Concentration From Baseline to Week 12|Change in hemoglobin concentration from baseline to Week 12.|Baseline to Week 12||||g/dL||Standard Deviation|Mean
2559380|NCT02680756|Primary|Number of Subjects Achieving Either a 2g/dL Increase in Hb OR Normalization of Hb (>12g/dL Women, >13g/dL Men) at Week 12|Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (>12g/dL women, >13g/dL men) at Week 12 results for intent to treat (ITT)|Baseline to Week 12|results for intent to treat (ITT)|||Participants|||Count of Participants
2559383|NCT02680665|Secondary|Proportion of Cyst Negative|"Proportion of cyst negative, which was defined as the percentage of participants with negative results in the examination of cysts after AMEPAROMO capsules up to 3 months after the completion of observation period or discontinuation of treatment, was presented along with its 2-sided 95% CI. The results of the examination of cysts were assessed as negative , positive, or indeterminate."|10 days + 3 months at maximum|The cyst analysis set consists of the participants in the safety analysis set who have undergone the cyst examination at the end of the observation period or at the time of treatment discontinuation. Participants with no information on cyst examination (53) and those with non-target disease (9) were excluded.|||Percentage of Participants||95% Confidence Interval|Number
2559384|NCT02680665|Primary|Number of Participants With Adverse Drug Reactions|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to AMEPAROMO capsules in a participant who received AMEPAROMO capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to AMEPAROMO capsules was assessed by the physician.|38 days at maximum|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received AMEPAROMO capsules at least once.|||Particpants|||Number
2559385|NCT02680639|Secondary|Minute Ventilation for Carbon Dioxide|Minute Ventilation in regards to the diffusion state of the lungs and carbon dioxide will be measured for each participant as they complete each arm.|20 minutes|Respiratory rate and Tidal volume were not able to be obtained for one participant. Therefore minute ventilation was not able to be calculated.|||mL/min||Standard Deviation|Mean
2559386|NCT02680639|Secondary|Tidal Volume|Minute ventilation in regards to volume of gas exchanged will be measured for each participant as they complete each arm.|20 minutes|Tidal volume was not able to be obtained for one participant.|||mL||Standard Deviation|Mean
2559387|NCT02680639|Secondary|Respiratory Rate|Minute ventilation in regards to respiratory rate and volume of gas exchanged will be measured for each participant as they complete each arm.|20 minutes|Respiratory rate was not able to be obtained for one participant.|||breaths per minute||Standard Deviation|Mean
2559388|NCT02680639|Primary|Carbon Dioxide Levels|Transcutaneous carbon dioxide (TcCO2) monitoring is a non-invasive alternative to arterial blood sampling. Carbon Dioxide Levels will be measured for each participant as they complete each arm.|Baseline and 20 minutes||||mmHg||Standard Deviation|Mean
2559389|NCT02680301|Other Pre-specified|Number of Patients Adhering to Treatment Protocol|Patient-reported adherence to wet-wrap protocol. Medication logs were used to evaluate adherence to the treatment protocol for both steroid formulations. Patents were determined to be adhering to the protocol if the number of wet-wraps for each study arm (cream or ointment) were the same. Because the total number of wraps varied between patients (the protocol required 1-2 wraps per day for 3-5 days), we reviewed medication logs to determine that each patient completed an equivalent number of ointment and cream wraps.|3-5 days|Patients ages 3 to 17 experiencing a symmetric, bilateral flare of atopic dermatitis.|||Participants|||Count of Participants
2559390|NCT02680301|Secondary|Patient Reported Efficacy|Patient report of which topical steroid formulation was more effective|3-5 days|Patients ages 3 to 17 experiencing a symmetric, bilateral flare of atopic dermatitis.|||Participants|||Count of Participants
2559391|NCT02680301|Primary|Efficacy of 0.1% Triamcinolone Containing Wet Wrap as an Ointment or as a Cream Formulation in Patients With Moderate to Severe Atopic Dermatitis|"Change in atopic dermatitis based on physician global assessment scale: 0=clear; 1=almost clear; 2=mild disease; 3=moderate disease; 4=severe disease; 5- very severe disease~Lower scores represent a better outcome."|3-5 days|Patients ages 3 to 17 experiencing a symmetric, bilateral flare of atopic dermatitis.|||units on a scale||Standard Deviation|Mean
2559392|NCT02680158|Other Pre-specified|Blood Pressure||1-Day|||||||
2559393|NCT02680158|Other Pre-specified|Oxygen Saturation||1-Day|||||||
2559394|NCT02680158|Other Pre-specified|Pulse Rate||1-Day|||||||
2559395|NCT02680158|Other Pre-specified|Slit Lamp Biomicroscopy||1-Day|||||||
2559396|NCT02680158|Other Pre-specified|Corrected Distance Visual Acuity||1-Day|||||||
2559397|NCT02680158|Primary|Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE)|An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in participants, users or other persons it does not necessarily have to have a causal relationship with the investigational medical device. Device-related AEs were presented as ocular and non-ocular.|Day 0|Safety population included all randomized participants who were exposed to study application.|||percentage of participants|eyes||Number
2559398|NCT02680158|Primary|Acute Stimulated Tear Production|Stimulated acute tear production in the study eye at Day 0 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm. The study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected. If there was no difference for either measure, the right eye was used as the study eye.|Day 0 post-application|The FAS population included all randomized participants who were exposed to study application.|||mm|eyes|Standard Deviation|Mean
2559399|NCT02680054|Other Pre-specified|Acceptability of Giving Insulin at Different Times Related to Test Meal|Would young people continue to give extra insulin injections for High Fat High Protein (HFHP) meals|questionnaires completed up to a week after the test meals||||Participants|||Count of Participants
2559400|NCT02680054|Secondary|Number of Participants With Hypoglycaemia Events Following the Insulin Dosing|All episodes of hypoglycaemia (BG less than 4 mmol/l) either on continuous glucose monitor or self-monitoring of BG|assessed up to 12 hours following the test meal||||Participants|||Count of Participants
2559401|NCT02680054|Primary|Time of Peak Glucose Level Following Test Meal|Glucose measured on the continuous subcutaneous glucose monitor|assessed up to 12 hours following the test meal||||Mins||Standard Deviation|Mean
2559402|NCT02680054|Primary|Peak Glucose Excursion From Baseline Following Test Meal|Glucose measured on the continuous subcutaneous glucose monitor|assessed up to 12 hours following the test meal||||mmol/l||Standard Deviation|Mean
2559404|NCT02680041|Secondary|The PPV of 18F-fluciclovine PET/CT for Distant Disease Compared to Biopsy in Those Patients Who Undergo a Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy|Based on the ratio of positive findings outside the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI|6 months|Only scans graded as positive or negative by the adjudication panel were included in these calculations.|||Percentage of scans||95% Confidence Interval|Number
2559405|NCT02680041|Secondary|The Positive Predictive Value (PPV) of 18F-fluciclovine PET/CT for Regional Disease Compared to Biopsy in Those Patients Who Undergo Biopsy or in Case of Bony Disease a Correlation With MRI or Biopsy|Based on the ratio of positive findings in the pelvis on 18F-fluciclovine PET/CT which are confirmed by histological examination of tissue or MRI|6 months|Only scans graded as positive or negative by the adjudication panel were included in these calculations.|||Percentage of scans||95% Confidence Interval|Number
2559406|NCT02680041|Secondary|The Rate of Detection of Disease in 1) Prostate and Prostate Bed and 2) Extra-prostatic Regions With 18F-fluciclovine PET/CT in the Study Population|The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT 1) in the pelvis and 2) distally|1 week|Participants may have lesions detected in both regions (prostate/prostate bed and extra-prostatic).|||Participants|||Count of Participants
2559407|NCT02680041|Secondary|The Rate of Detection of Any Disease Site by 18F-fluciclovine PET/CT in the Study Population|The percentage of subjects who have disease detectable by 18F-fluciclovine PET/CT|1 week|Results presented for Full Analysis Set|||Participants|||Count of Participants
2559408|NCT02680041|Secondary|The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Actual Treatment|"The change of management will be based on referring physician questionnaires completed pre- 18F-fluciclovine PET/CT and changes reported at 6 month follow-up.~Investigators were instructed to assess any clinically significant change from the revised management plan."|6 months|"211 participants completed the study (actual treatment assessed at study completion).~Results also presented by 18F-fluciclovine PET CT results."|||Participants|||Count of Participants
2559409|NCT02680041|Primary|The Fraction of Patients for Whom 18F-fluciclovine PET/CT Alters Patient Planned Treatment Through Detection of Disease.|The change of management will be based on referring physician questionnaires completed pre- and post- 18F-fluciclovine PET/CT|2-22 days post PET CT|For the primary analysis population, of the 213 patients included in the EAS, 122 patients with a positive 18F-fluciclovine scan and 91 patients with a negative 18F-fluciclovine scan had a pre 18F-fluciclovine PET/CT treatment management plan.|||Participants|||Count of Participants
2559410|NCT02679976|Primary|Intermediate Binocular LogMAR Visual Acuity|intermediate Binocular LogMAR Visual Acuity was measured at 67cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )|4 Hr. Post Fitting|The analysis population includes all subjects that completed the study without a major protocol deviation.|||-10*LogMAR||Standard Deviation|Mean
2559411|NCT02679976|Primary|Near Binocular LogMAR Visual Acuity|Near Binocular LogMAR Visual Acuity was measured at 40cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )|4 Hr. Post Fitting|The analysis population includes all subjects that completed the study without a major protocol deviation.|||-10*LogMAR||Standard Deviation|Mean
2559412|NCT02679976|Primary|Distance Binocular LogMAR Visual Acuity|Distance Binocular LogMAR Visual Acuity was measured at 4m for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )|4 Hr. Post Fitting|The analysis population includes all subjects that completed the study without a major protocol deviation.|||-10*LogMAR||Standard Deviation|Mean
2559413|NCT02679911|Secondary|% Subjects Satisfied to Very Satisfied With Each Study Treatment at Week 12|Percent of subjects satisfied to very satisfied with both treatments (Loceryl nail lacquer and/or Ciclopirox nail lacquer) at week 12|Week 12|ITT population|||percentage of participants|||Number
2559414|NCT02679911|Primary|"% in Label Adherent Subjects"|Percent of subjects having applied both treatments as instructed per labeling (once a week for Loceryl NL and once a day for Ciclopirox after 2 weeks)|Week 12|Intention To Treat popoulation (ITT)|||percentage of participants|||Number
2559415|NCT02679807|Primary|Number of Participants With Rhinovirus-associated Illness Episodes|Rhinovirus-associated illness episodes: Volunteers who have both a rhinovirus infection and a symptomatic illness will be defined as having a rhinovirus-associated common cold illness.|5 days|Volunteers who were challenged with rhinovirus, completed the study period and did not have any evidence by PCR or serology of a viral infection with a virus other than the challenge virus|||Participants|||Count of Participants
2559416|NCT02679729|Secondary|Apparent Volume of Distribution for AZD5634 at Terminal Phase (Inhaled Administration), Estimated by Dividing the CL/F by λz (Part A and Part B Inhaled Dosing Only) (Vz/F)|To assess the pharmacokinetic parameter Vz/F of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.|At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)|The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.|||Litre||Standard Deviation|Mean
2559417|NCT02679729|Secondary|Volume of Distribution for AZD5634 at Terminal Phase (IV Administration), Estimated by Dividing the Systemic CL by λz (Part B IV Dosing Only) (Vz)|To assess the pharmacokinetic parameter Vz of AZD5634 following single-dose IV administration of AZD5634 in Part B|At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)|The PK analysis set for Part B consisted of all participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated in each treatment period, with no major protocol deviations thought to impact on the analysis of the PK data.|||Litre||Standard Deviation|Mean
2559533|NCT02677779|Primary|Bacterial Load|Percent change in bacterial colonies from baseline.|Percent change in bacterial colonies from baseline. Variation from baseline and immediately after the end of procedure.|Per-protocol analysis: patients with no detectable bacterial load at baseline were excluded.|||Percent change from baseline||Inter-Quartile Range|Median
2559418|NCT02679729|Secondary|Volume of Distribution for AZD5634 at Steady State (IV Administration), Estimated by Dividing the MRT by the Systemic CL (Part B IV Dosing Only) (Vss)|To assess the pharmacokinetic parameter Vss of AZD5634 following single-dose IV administration of AZD5634 in Part B|At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)|The PK analysis set for Part B consisted of all participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated in each treatment period, with no major protocol deviations thought to impact on the analysis of the PK data.|||Litre||Standard Deviation|Mean
2559419|NCT02679729|Secondary|Mean Absorption Time, Calculated as MRTinhaled - MRTIV (Part B Only) (MAT)|To assess the pharmacokinetic parameter MAT of AZD5634 following single-dose IV or inhalation administration of AZD5634 in Part B|At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)|The PK analysis set for Part B consisted of all participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated in each treatment period, with no major protocol deviations thought to impact on the analysis of the PK data.|||hour||Standard Deviation|Mean
2559420|NCT02679729|Secondary|Mean Residence Time (MRT) - For Part A and Part B|To assess the pharmacokinetic parameter MRT of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose IV or inhalation administration of AZD5634 in Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.|At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)|The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.|||hour||Standard Deviation|Mean
2559421|NCT02679729|Secondary|Apparent Clearance for AZD5634 Estimated as Dose Divided by AUC (Part A and Part B Inhaled Dosing Only) (CL/F)|To assess the pharmacokinetic parameter CL/F of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose inhalation administration of AZD5634 in Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.|At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)|The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.|||L/h||Standard Deviation|Mean
2559422|NCT02679729|Secondary|Systemic Clearance for AZD5634 Estimated as Dose Divided by AUC (Part B IV Dosing Only) (CL)|To assess the pharmacokinetic parameter CL of AZD5634 following single-dose IV administration of AZD5634 in Part B|At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)|The PK analysis set for Part B consisted of all participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated in each treatment period, with no major protocol deviations thought to impact on the analysis of the PK data.|||L/h||Standard Deviation|Mean
2559423|NCT02679729|Secondary|AUC, Divided by the Dose Administered (AUC/Dose) - For Part A and Part B|To assess the pharmacokinetic parameter AUC/Dose of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose IV or inhalation administration of AZD5634 in Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.|At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)|The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.|||h*nmol/L/umol||Geometric Coefficient of Variation|Geometric Mean
2559424|NCT02679729|Secondary|AUC0-t, Divided by the Dose Administered (AUC0-t/Dose) - For Part A and Part B|To assess the pharmacokinetic parameter AUC0-t/Dose of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose IV or inhalation administration of AZD5634 in Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.|At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)|The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.|||h*nmol/L/umol||Geometric Coefficient of Variation|Geometric Mean
2559425|NCT02679729|Secondary|Terminal Half-life (t1/2λz), Estimated as (ln2)/λz - For Part A and Part B|To assess the pharmacokinetic parameter t1/2λz of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose IV or inhalation administration of AZD5634 in Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.|At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)|The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.|||Hours||Standard Deviation|Mean
2561388|NCT02650921|Secondary|Question 5 From Subject Satisfaction Questionnaire|Question 5: The skin on my treated hand appears tighter than on my untreated hand|Week 12|ITT|||Participants|||Count of Participants
2559426|NCT02679729|Secondary|Cmax, Divided by the Dose Aministered (Cmax/Dose) - For Part A and Part B|To assess the pharmacokinetic parameter Cmax/Dose of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose IV or inhalation administration of AZD5634 in Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.|At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)|The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.|||nmol/L/umol||Geometric Coefficient of Variation|Geometric Mean
2559427|NCT02679729|Secondary|Renal Clearance (CLR), Estimated by Dividing Ae(0-last) by AUC0-t - For Part A and Part B|To assess the pharmacokinetic parameter CLR of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose IV or inhalation administration of AZD5634 in Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.|-12-0, 0-6, 6-12, 12-24, 24-48 h (Days 1 to 3)|The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.|||L/h||Standard Deviation|Mean
2559428|NCT02679729|Secondary|Absolute Systemic Bioavailability After Inhalation (Part B Only) (Finhalation,Total)|To assess the Absolute systemic bioavailability after inhalation (%), calculated separately as 100*AUCinhalation*Doseiv/(AUCiv*Doseinhalation)|At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)|The PK analysis set for Part B consisted of all participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated in each treatment period, with no major protocol deviations thought to impact on the analysis of the PK data.|||Percentage of bioavailable dose||Geometric Coefficient of Variation|Geometric Mean
2559429|NCT02679729|Secondary|Area Under the Plasma Concentration-curve From Time Zero to Time of Last Quantifiable Concentration [AUC(0-t)] for Part A and Part B|To assess the pharmacokinetic parameter AUC(0-t) of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose IV or inhalation administration of AZD5634 in Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.|At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)|The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2559430|NCT02679729|Secondary|Area Under Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC) for Part A and Part B|To assess the pharmacokinetic parameter AUC of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose IV or inhalation administration of AZD5634 in Part B. AUC was estimated by AUC(0-last) + Clast/λz where Clast was the last observed quantifiable concentration. AUCs were calculated using the linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. AUC0-t is expanded as area under the plasma concentration-time curve from time zero to time of last quantifiable concentration. Note:Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.|At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)|The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2559431|NCT02679729|Secondary|Observed Maximum Plasma Concentration, Taken Directly From the Individual Concentration-time Curve (Cmax)- For Part A and Part B|To assess the pharmacokinetic (PK) parameter Cmax of AZD5634 following single-dose inhalation administration of AZD5634 in Part A and following single-dose IV or inhalation administration of AZD5634 in Part B. Note: Due to the participant and/or data exclusion described above, there are no PK data available for the 10 μg dose cohort and very limited data for the 27 μg dose cohort. Therefore, these 2 cohorts were not included in PK results interpretation and summary statistics.|At predose, at 5, 15 and 30 min and at 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 h postdose (Days 1 to 3)|The PK analysis set for Part A consisted of participants in the safety analysis set who received AZD5634 and for Part B consisted of participants who completed both treatment periods and for whom at least one of the PK parameters Cmax, AUC0-t or AUC were calculated, with no major protocol deviations thought to impact on the analysis of the PK data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2559432|NCT02679729|Primary|Safety and Tolerability of AZD5634 Following Inhaled Administration of Single-ascending Doses (SAD) (Part A) and Following Administration of Single Inhaled and IV Doses (Part B).|To assess the safety and tolerability of AZD5634 in terms of number of participants following inhaled administration of single-ascending doses (SAD) (Part A) and following administration of single inhaled and IV doses (Part B)|Screening (serious adverse event, SAE), Day -1 (SAE), Spontaneous plus Predose, 3,12,24, and 48 h postdose (Days 1 to 3), Follow-up 7-10 days postdose, 2 months post final dose.|All partcipants in safety analysis set who received at least 1 dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||Participants|||Number
2561389|NCT02650921|Secondary|Question 4 From Subject Satisfaction Questionnaire|Question 4: My treated hand feels softer than my untreated hand|Week 12|ITT|||Participants|||Count of Participants
2559433|NCT02679690|Secondary|Mean of Milligrams of Sodium for All Grocery Items That Were Chosen by the Total of All Participants Pre, and Post Intervention|All 15 grocery items were tallied for all ten participants after the first standard dietary sodium education, with the mean obtained. This was repeated with the 9 participants who chose 15 grocery items after completing the color-coded cue card education intervention.|two weeks and one month|The mean milligrams of sodium per serving from the 15 items of groceries chosen after standardized dietary sodium education, and then again after the education regarding the use of color-coded cue cards for dietary sodium.|||milligrams||Standard Deviation|Mean
2559434|NCT02679690|Primary|Difference in Mean Milligrams of Dietary Sodium in Chosen Foods Pre- and Post- Color Coded Cue Card Intervention|Each participant chose 15 grocery items at baseline (before) and after color-coded cue card dietary sodium education intervention. The outcome was the difference of the paired mean of each participant from their 15 grocery items chosen pre and post intervention.|two weeks and one month|9 participants who completed both PowerPoint educations and both grocery store food choices.|||milligrams||Standard Deviation|Mean
2559435|NCT02679573|Secondary|All-cause Mortality|Time to all-cause Mortality was assessed on Day 28.|Day 28 (+/- 2 days)|ITT (intent-to-treat) Population is all the randomized patients with a signed Informed consent form. Subjects were analyzed according to the treatment arm to which they were randomized.|||Participants|||Count of Participants
2559436|NCT02679573|Secondary|Microbiologic Response|Microbiological response for subjects in the MITT set will be based on results of the baseline and follow-up cultures and susceptibility testing or serology.|5 to 10 days after the last dose of study drug|Microbiological ITT 1 (MITT-1) includes all subjects in the ITT population with a baseline bacterial pathogen identified that was known to cause CABP and against which the study drug had antibacterial activity.|||Participants|||Count of Participants
2559437|NCT02679573|Secondary|Clinical Outcome at End of Treatment|Clinical outcome (Success, Failure, or Indeterminate/missing) based on the investigator's assessment of the patient's signs and symptoms of infection in the ITT population.|Up to 24 (+4) hours after the last dose of study drug|ITT (intent-to-treat) Population is all the randomized patients with a signed Informed consent form. Subjects were analyzed according to the treatment arm to which they were randomized.|||Participants|||Count of Participants
2559438|NCT02679573|Secondary|Clinical Outcome at Test of Cure|Clinical outcome (Success, Failure, or Indeterminate/missing) based on the investigator's assessment of the patient's signs and symptoms of infection in the ITT population.|5 to 10 days after the last dose of study drug|ITT (intent-to-treat) Population is all the randomized patients with a signed Informed consent form. Subjects were analyzed according to the treatment arm to which they were randomized.|||Participants|||Count of Participants
2559439|NCT02679573|Secondary|Early Clinical Response Plus Improvement in Vital Signs and no Worsening of the 4 Symptoms|Early clinical response with the addition of improvement in vital signs and no worsening of the following 4 symptoms: chest pain, cough, productive sputum, and difficulty breathing in the ITT population. Symptom severity evaluated by the investigator on a 4-point scale: Absent (0), Mild (1), Moderate (2), Severe (3). Improvement defined as at least a 1-point decrease from baseline. Improvement in vital signs defined as a return to normal of any abnormal vital signs at baseline, and no worsening (ie, be abnormal) of any vital sign that was normal at baseline.|96 (+/- 24) hours after the first dose of study drug|ITT (intent-to-treat) Population is all randomized patients with a signed Informed consent form. Subjects were analyzed according to the treatment arm to which they were randomized.|||Participants|||Count of Participants
2559440|NCT02679573|Primary|Early Clinical Response|Early clinical response defined as improvement in at least 2 of the following symptoms (as assessed by the investigator): chest pain, frequency or severity of cough, amount and quality of productive sputum, and difficulty breathing, and no worsening of the other symptoms in the ITT population. Symptom severity evaluated by the investigator on a 4-point scale: Absent (0), Mild (1), Moderate (2), Severe (3). Improvement defined as at least a 1-point decrease from baseline.|96 (+/- 24) hours after the first dose of study drug|ITT (intent-to-treat) Population is all the randomized patients with a signed Informed consent form. Subjects were analyzed according to the treatment arm to which they were randomized.|||Participants|||Count of Participants
2559441|NCT02679469|Primary|Measure the Terminal-phase Elimination Half-life (T1/2)||pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose||||hours||Full Range|Median
2559442|NCT02679469|Primary|Measure the Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t(AUCt)||pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose||||ng･h/mL||Standard Deviation|Mean
2559443|NCT02679469|Primary|‎Measure the Maximum (Peak) Plasma Concentration of the Drug (Cmax||pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose||||ng/mL||Standard Deviation|Mean
2559444|NCT02679274|Secondary|Chair Raise as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks|During the chair rise section of the Short Physical Performance Battery (SPPB), subjects are timed while they rise from a seated (chair) to standing position. Subjects perform this task 5 times and data is presented as their best time.|10 Weeks||||seconds|||Number
2559445|NCT02679274|Secondary|Chair Raise as Measured by Short Physical Performance Battery (SPPB) at Baseline|During the chair rise section of the Short Physical Performance Battery (SPPB), subjects are timed while they rise from a seated (chair) to standing position. Subjects perform this task 5 times and data is presented as their faster time.|baseline||||seconds|||Number
2559446|NCT02679274|Secondary|Change in Gait Speed as Measured by Short Physical Performance Battery (SPPB).|During the gait speed section of the Short Physical Performance Battery (SPPB) subjects are timed while walking a predefined 4 meter course. Data is shown as change in speed (meters/second) from baseline (0 weeks) to 10 weeks. A increase in speed indicates a better outcome.|0 to 10 Weeks||||meters/second|||Number
2559447|NCT02679274|Secondary|Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks|During the Tandem Balance section of the Short Physical Performance Battery (SPPB) subjects are asked to stand with their feet in a tandem stance (heel of one foot directly in front of the toes of the other foot) and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.|10 Weeks||||seconds|||Number
2561390|NCT02650921|Secondary|Question 3 From Subject Satisfaction Questionnaire|Question 3: My treated hand looks more youthful than my untreated hand|Week 12|ITT|||Participants|||Count of Participants
2559448|NCT02679274|Secondary|Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline|During the Tandem Balance section of the Short Physical Performance Battery (SPPB) subjects are asked to stand with their feet in a tandem stance (heel of one foot directly in front of the toes of the other foot) and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.|baseline||||seconds|||Number
2559449|NCT02679274|Secondary|Semi-Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks.|During the Semi-Tandem Balance section of the Short Physical Performance Battery (SPPB) subjects are asked to stand with their feet in a semi-tandem stance (heel of one foot placed to side of the first toe of the other foot) and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.|10 Weeks||||seconds|||Number
2559450|NCT02679274|Secondary|Semi-Tandem Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline|During the Semi-Tandem Balance section of the Short Physical Performance Battery (SPPB) subjects are asked to stand with their feet in a semi-tandem stance (heel of one foot placed to side of the first toe of the other foot) and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.|baseline||||seconds|||Number
2559451|NCT02679274|Secondary|Side by Side Balance as Measured by Short Physical Performance Battery (SPPB) at 10 Weeks|During the Short Physical Performance Battery (SPPB) side by side balance test subjects are asked to stand with their feet together and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.|10 Weeks||||seconds|||Number
2559452|NCT02679274|Secondary|Side by Side Balance as Measured by Short Physical Performance Battery (SPPB) at Baseline|During the Short Physical Performance Battery (SPPB) side by side balance test subjects are asked to stand with their feet together and balance for a maximum of 10 seconds. If they are unable to perform balance test, they receive a score of 0 seconds, maximum score is 10 seconds. A higher score indicates a better outcome.|baseline||||seconds|||Number
2559453|NCT02679274|Secondary|Change in Hip Abduction Strength (Supine)|Collected using a manual muscle tester (MMT).|0 to 10 Weeks||||kg|||Number
2559454|NCT02679274|Secondary|Change in Knee Extension Strength (Seated)|Collected using a manual muscle tester (MMT).|0 to 10 Weeks||||kg|||Number
2559455|NCT02679274|Secondary|Change in Handgrip Strength|Measured using a handgrip dynamometer|0 to 10 Weeks||||kg|||Number
2559456|NCT02679274|Primary|Change in Fat-free Mass as Measured by Bioelectric Impediance Analysis (BIA)|Fat-free Mass (kg) calculated from total weight (kg) and percent body fat (%) obtained during bioelectric impedance analysis (BIA).|0 to 10 Weeks||||kg|||Number
2559457|NCT02679235|Secondary|Change in Cerebral Blood Flow|change in cerebral blood flow measured by arterial spin labeling (ASL) and calculated using a one-compartment model (average cortex)|28±2 days||||ml/100 g/ min||Standard Deviation|Mean
2559458|NCT02679235|Secondary|Change in Integrity of Brain White Matter Tracts|Fiber-bundle segmentation and fiber tractography by diffusion-weighted MRI (HARDI)|28±2 days||2020-02-29|02/2020||||
2559459|NCT02679235|Secondary|Change in Seed-based Correlation Maps|Change in seed-based correlation maps brain connectivity by RS-fMRI|28±2 days||2020-02-29|02/2020||||
2559460|NCT02679235|Secondary|Change in Brain Volumes|Structural imaging by T1-weighted MRI to measure brain volume|28±2 days|data was not available for 2 participants|||ml/100 g/ min||Standard Deviation|Mean
2559461|NCT02679235|Primary|Global Change in Brain Ketone Uptake|Global change in brain ketone uptake as measured by 11C-acetoacetate PET scans|28±2 days||||μmol/100 g/min||Standard Deviation|Mean
2559462|NCT02679235|Primary|Global Change in Brain Glucose Uptake|Global change (average of cortex) in brain glucose uptake as measured by 18F-FDG PET scans PRE vs POST 28±2 days of supplementation|28±2 days||||μmol/100 g/min||Standard Deviation|Mean
2559463|NCT02679222|Secondary|Plasma Acetoacetate/Beta-hydroxybutyrate Ratio|Plasma ratio of acetoacetate (µmol/L)/ beta-hydroxybutyrate (µmol/L) measured over a 8 hour period (i.e area-under-the-curve over 8 hours).|8 hours||||Ratio||Standard Deviation|Mean
2559464|NCT02679222|Primary|Plasma Ketone Concentrations|"Total ketones = Plasma acetoacetate (µmol/L) + beta-hydroxybutyrate (µmol/L) measured over a 8 hour period (i.e. daily mean).~Samples are taken every 30 minutes on a 8 hours period. The mean is reported here."|8 hours||||µmol/L||Standard Deviation|Mean
2559465|NCT02679066|Secondary|Disabilities of the Arm, Shoulder and Hand (DASH) Score - Upper Extremity Function|This is a validated survey of upper extremity function that is administered at the two week follow up visit. The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability).|Two weeks|No data was measured due to inconsistent collection of DASH score and patient follow up.||||||
2559466|NCT02679066|Primary|Number of Participants With Maintenance of Reduction|Radiologic parameters to include radial height, radial inclination and volar tilt will be measured from post-immobilization radiographs at presentation, one week, two weeks and four weeks. Maintenance of reduction will be defined as: loss of reduction of < 2 mm radial height, < 5 degrees of radial inclination or < 10 degrees of volar tilt and/or < 2 mm intra-articular step off, in follow up radiographs as compared to immediate post-reduction radiographs.|one month|No data was collected to allow analysis.||||||
2559467|NCT02678923|Secondary|Participants With Regression Of Coronary Atherosclerosis As Measured By A PAV Change <0|The number of participants with regression of coronary atherosclerosis is presented. For this Outcome Measure, the regression of coronary atherosclerosis is defined as a change in PAV from Baseline to Day 36 of less than zero.|Baseline through Day 36|mITT population included all participants who were screened, enrolled, randomized, received at least one infusion of study drug, and who had an evaluable Baseline and Follow-up IVUS assessment.|||Participants|||Count of Participants
2559597|NCT02675517|Secondary|General Condition of the Patient, Evaluated by the Physician (PGE Score) at Visit 1 and Visit 2.|Physician's Global Evaluation (PGE) score documented by physicians at visit 1 (baseline) and at visit 2 (approx. 6 weeks later). the PGE score documented from 1 to 8. The highest value (=8) representing an excellent general condition|Baseline (Visit 1) and Week 6 (approx.) (Visit 2)|FAS|||Percentage of participants|||Number
2559468|NCT02678923|Secondary|Participants With Regression Of Coronary Atherosclerosis As Measured By A PAV Change Greater Than 2 Standard Deviations Of Test-Retest Measurement Variability|The number of participants with regression of coronary atherosclerosis is presented. For this Outcome Measure, the regression of coronary atherosclerosis is defined as a reduction in PAV from Baseline to Day 36 of greater than 2 standard deviations of the test-retest variability.|Baseline through Day 36|mITT population included all participants who were screened, enrolled, randomized, received at least one infusion of study drug, and who had an evaluable Baseline and Follow-up IVUS assessment.|||participants|||Number
2559469|NCT02678923|Secondary|Change From Baseline In TAV For The 10 Millimeters (mm) Subsegment With The Greatest Disease Burden At Day 36|Change in TAV from Baseline to Day 36 post-randomization of the most diseased 10-mm subsegment, as determined by IVUS. The change is calculated by subtracting the value at Baseline from the value at Day 36, with positive numbers to represent increases and negative numbers to represent decreases. Change in TAV was analyzed using an analysis of covariance (ANCOVA) model that included Baseline TAV for the most diseased 10-mm subsegment as a covariate and treatment group as factor. LS mean was adjusted for stratification factors of country and prior statin use.|Baseline, Day 36|mITT population included all participants who were screened, enrolled, randomized, received at least one infusion of study drug, and who had an evaluable Baseline and Follow-up IVUS assessment.|||mm^3||Standard Error|Least Squares Mean
2559470|NCT02678923|Secondary|Change From Baseline In Total Atheroma Volume (TAV) At Day 36|Change from Baseline to Day 36 post-randomization in normalized TAV in a targeted (imaged) coronary artery for all anatomically comparable slices, as determined by IVUS. The change is calculated by subtracting the value at Baseline from the value at Day 36, with positive numbers to represent increases and negative numbers to represent decreases. Change in TAV was analyzed using an analysis of covariance (ANCOVA) model that included Baseline TAV as a covariate and treatment group as factor. LS mean was adjusted for stratification factors of country and prior statin use.|Baseline, Day 36|mITT population included all participants who were screened, enrolled, randomized, received at least one infusion of study drug, and who had an evaluable Baseline and Follow-up IVUS assessment.|||cubic millimeter (mm^3)||Standard Error|Least Squares Mean
2559471|NCT02678923|Primary|Change From Baseline In Percent Atheroma Volume (PAV) At Day 36|Change from Baseline to Day 36 post-randomization in PAV in a targeted (imaged) coronary artery for all anatomically comparable slices, as determined by IVUS. The change is calculated by subtracting the value at Baseline from the value at Day 36, with positive numbers to represent increases and negative numbers to represent decreases. Change in PAV was analyzed using an analysis of covariance (ANCOVA) model that included Baseline PAV as a covariate and treatment group as factor. Least Squares (LS) mean was adjusted for stratification factors of country and prior statin use.|Baseline, Day 36|mITT population included all participants who were screened, enrolled, randomized, received at least one infusion of study drug, and who had an evaluable Baseline and Follow-up IVUS assessment.|||change in percent||Standard Error|Least Squares Mean
2559472|NCT02678676|Secondary|Incidences With Malignancies|Percentage of participants with incidences of at least 1 malignancy was reported. All malignancies included adrenal, biliary, bladder, brain, breast, cervix, colon/rectal, gastric, hematological, hepatic, lung, mesothelioma, metastases, oesophageal, oropharyngeal, ovarian/uterine, pancreas, prostate, renal, skin and others.|Up to Year 10|The observational study population consisted of participants who enrolled in this study after completing the final visit of PROactive study (NCT00174993).|||percentage of participants|||Number
2559473|NCT02678676|Primary|Percentage of Participants With First Occurrence of Macro-vascular Event or Death|The composite macro-vascular event or death included all-cause mortality, non-fatal myocardial infarction, cardiac intervention, stroke, major leg amputation (above the ankle), bypass surgery or revascularization in the leg. The percentage of participants in the observational study population having first occurrence of macro-vascular event or death during the 10-year observational study period was analyzed. The data were analyzed using the Cox regression with respect to time to the first occurrence of macro-vascular event or death.|Up to Year 10|The observational study population consisted of participants who enrolled in this study after completing the final visit of PROactive study (NCT00174993).|||percentage of participants|||Number
2559474|NCT02678442|Secondary|Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation|The number of subjects whose first pass biopsy contained adequate material for high quality histologic interpretation, as determined by a cytopathologist. High quality is defined as being greater than 10 power field in length.|Baseline||||Participants|||Count of Participants
2559475|NCT02678442|Secondary|Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation|The total number of subjects whose first-pass biopsy contained adequate material for cytologic interpretation, as determined by a cytopathologist.|Baseline||||Participants|||Count of Participants
2559476|NCT02678442|Secondary|Percentage of Tumor Cellularity|Percent of tumor cellularity with first pass of adenocarcinoma|Baseline||||percentage of tumor cellularity||Full Range|Median
2559477|NCT02678442|Secondary|Concentration of DNA Yield of Adenocarcinoma|The concentration of the DNA from the adenocarcinoma on the first needle pass, measured in micrograms per microliter.|Baseline||||µg/mL||Standard Deviation|Mean
2559478|NCT02678442|Secondary|Core Tissue Length|The length of the tissue core sample acquired, on the first needle pass, measured in centimeters.|Baseline||||centimeters||Full Range|Median
2559479|NCT02678442|Secondary|Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis|The total number of passes required to obtain adequate tissue sample for cytology/histology processing and interpretation.|Baseline||||needle passes||Full Range|Median
2559480|NCT02678442|Primary|Total DNA Yield of Adenocarcinoma|Total quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL.|Baseline||||ng/µL||Standard Deviation|Mean
2559481|NCT02678416|Secondary|Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area|Participants rated their pain intensity on a scale of 0 (no pain) to 10 (most intense pain). The observed mean and standard deviation are disclosed through Hour 6|within 6 hours|Per-Protocol Population, defined as participants who were enrolled in the study, have taken the entire dose of all study drugs, and provided all pain intensity assessments designed for the UVB Burn Pain Model without a major protocol deviation.|||scores on a scale||Standard Deviation|Mean
2559482|NCT02678416|Primary|Part 1: Change From Baseline in Pain Intensity at Hour 6 Using the Thermal Suprathreshold Pain in the Ultraviolet-B (UVB) Burn Pain Model|The UVB burn pain model is a validated screening tool for pain killers in clinical drug development. A temperature of 50 degrees centigrade (°C) is used to burn the participant for 5 seconds. Then the participant rates his pain on a scale from 0 (no pain) to 10 (most intense pain). That score is recorded as baseline. Then the participant rates his pain again six hours after taking the assigned medication. The average at baseline is subtracted from the average at hour 6. Because this is a measure of reduction in pain intensity, a higher score is better (it means there is more pain relief).|within 6 hours|Completers, defined as participants who were enrolled in the study, took the entire dose of all study drugs, and provided all pain intensity assessments.|||score on a scale||Standard Deviation|Mean
2559483|NCT02678390|Secondary|Plasma Insulin Concentrations|Insulin (nmol/L) measured in the plasma The area under the curve (AUC) was calculated according to the trapezoidal method from 0 to 4 h during the visits (interventions) CTL = Metabolic study day (Day 1) MCT = Metabolic study day after 5 days of supplementation (Day 5) AE= Metabolic Study day after acute aerobic exercise (Day 6) AE + MCT = Metabolic Study day after 5 days of aerobic exercise and mct supplementation (Day 11)|5 days||||(nmol*h)/L||Standard Deviation|Mean
2559484|NCT02678390|Secondary|Plasma Free Fatty Acid Concentrations|Free fatty acids (mmol/L) measured in the plasma The area under the curve (AUC) was calculated according to the trapezoidal method from 0 to 4 h during the visits (interventions) CTL = Metabolic study day (Day 1) MCT = Metabolic study day after 5 days of supplementation (Day 5) AE= Metabolic Study day after acute aerobic exercise (Day 6) AE + MCT = Metabolic Study day after 5 days of aerobic exercise and mct supplementation (Day 11)|5 days||||(mmol*h)/L||Standard Deviation|Mean
2559485|NCT02678390|Secondary|Plasma Triglyceride Concentrations|Triglycerides (mmol/L) measured in the plasma The area under the curve (AUC) was calculated according to the trapezoidal method from 0 to 4 h during the visits (interventions) CTL = Metabolic study day (Day 1) MCT = Metabolic study day after 5 days of supplementation (Day 5) AE= Metabolic Study day after acute aerobic exercise (Day 6) AE + MCT = Metabolic Study day after 5 days of aerobic exercise and mct supplementation (Day 11)|5 days||||(mmol*h)/L||Standard Deviation|Mean
2559486|NCT02678390|Secondary|Plasma Glucose Concentrations|Glucose (mmol/L) measured in the plasma The area under the curve (AUC) was calculated according to the trapezoidal method from 0 to 4 h during the visits (interventions) CTL = Metabolic study day (Day 1) MCT = Metabolic study day after 5 days of supplementation (Day 5) AE= Metabolic Study day after acute aerobic exercise (Day 6) AE + MCT = Metabolic Study day after 5 days of aerobic exercise and mct supplementation (Day 11)|5 days||||(mmol*h)/L||Standard Deviation|Mean
2559487|NCT02678390|Primary|Plasma Ketone Concentrations|Acetoacetate (umol/L) and beta-hydroxybutyrate (umol/L); Called Ketones (µmol/L) when combine together The area under the curve (AUC) was calculated according to the trapezoidal method from 0 to 4 h during the visits (interventions) CTL = Metabolic study day (Day 1) MCT = Metabolic study day after 5 days of supplementation (Day 5) AE= Metabolic Study day after acute aerobic exercise (Day 6) AE + MCT = Metabolic Study day after 5 days of aerobic exercise and mct supplementation (Day 11)|5 days||||(µmol/h)/L||Standard Deviation|Mean
2559488|NCT02678286|Secondary|Patient Global Assessment (PGA) of Pain Control at Hour 48|PGA of pain control was evaluated at Hour 24 and Hour 48 with subject reported degree of pain control over the preceding interval according to a 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent.|48 Hours|ITT Population|||Participants|||Count of Participants
2559489|NCT02678286|Secondary|Patient Global Assessment (PGA) of Pain Control at Hour 24|PGA of pain control was evaluated at Hour 24 and Hour 48 with subject reported degree of pain control over the preceding interval according to a 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent.|24 Hours|ITT Population|||Participants|||Count of Participants
2559490|NCT02678286|Secondary|Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 24|"Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 24 = 100 * SPID24 / (BaselinePI~* 24 * 60), and SPID24 < 0 as an indication for improvement."|24 Hours|ITT Population|||Participants|||Count of Participants
2559491|NCT02678286|Secondary|Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 6|Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 6 = 100 * SPID6 / (BaselinePI * 6 * 60), and SPID6 < 0 as an indication for improvement.|6 Hours|ITT Population|||Participants|||Count of Participants
2559492|NCT02678286|Secondary|Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 24|"Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 24 = 100 * SPID24 / (BaselinePI~* 24 * 60), and SPID24 < 0 as an indication for improvement."|24 Hours|ITT Population|||Participants|||Count of Participants
2559493|NCT02678286|Secondary|Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 6|Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 6 = 100 * SPID6 / (BaselinePI * 6 * 60), and SPID6 < 0 as an indication for improvement.|6 Hours|ITT Population|||Participants|||Count of Participants
2559494|NCT02678286|Secondary|Time to Meaningful Pain Relief (TTMPR)|Time to perceptible and meaningful pain relief was measured using the double stopwatch method. For each randomized subject, two stopwatches were started immediately after administration of the first study dose (Hour 0). The subject was to stop the first watch when they first perceived pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they first experienced meaningful pain relief (time to meaningful relief).|12 Hours|ITT Population|||hours||95% Confidence Interval|Median
2559495|NCT02678286|Secondary|Time to Perceptible Pain Relief (TTPPR)|Time to perceptible and meaningful pain relief was measured using the double stopwatch method. For each randomized subject, two stopwatches were started immediately after administration of the first study dose (Hour 0). The subject was to stop the first watch when they first perceived pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they first experienced meaningful pain relief (time to meaningful relief).|12 Hours|ITT Population|||hours||95% Confidence Interval|Median
2559496|NCT02678286|Secondary|Number of Doses of Rescue Analgesia Utilized Per Subject|Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.|48 Hours|ITT Population|||doses of rescue analgesia||Standard Error|Least Squares Mean
2559497|NCT02678286|Secondary|Number of Subjects Utilizing Rescue Analgesia|Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.|48 Hours|ITT Population|||Participants|||Count of Participants
2559498|NCT02678286|Secondary|Time to First Dose of Rescue Analgesia|Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request. Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.|48 Hours|ITT Population|||hours||95% Confidence Interval|Median
2559499|NCT02678286|Secondary|Summed Pain Intensity Difference (SPID) at Other Intervals|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.|48 Hours|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2559500|NCT02678286|Primary|Summed Pain Intensity Difference Over the First 24 Hours (SPID24)|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.|24 Hours|Intent-to-Treat (ITT) population|||units on a scale||Standard Error|Least Squares Mean
2559501|NCT02678039|Secondary|Postoperative Pain Intensity Measured by Numeric Scale|Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).|3 months after surgery during follow up office visit with surgeon|Insufficient data were collected for this analysis||||||
2559502|NCT02678039|Secondary|Postoperative Pain Intensity Measured by Numeric Scale|Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).|Measured at 48 hours after surgery||||milligrams||Standard Deviation|Mean
2559503|NCT02678039|Secondary|Postoperative Pain Intensity Measured by Numeric Scale|Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).|Measured at 24 hours after surgery||||units on a scale of 0 to 10||Standard Deviation|Mean
2559504|NCT02678039|Secondary|Incidence of Epidural Catheter Failure|Percent of epidural catheters that were correctly placed (percentage of catheters).|24 hours after surgery||||percentage of catheters|||Number
2559505|NCT02678039|Primary|Intravenous Pain Medication|Outcome measure is mg of morphine equivalent used in first 24 hours after surgery: Postoperative pain medication use during the first 24 postoperative hours will be calculated by converting medication to an equivalent amount of morphine. This is an indirect measure of postoperative pain.|24 hours after surgery||||milligrams||Standard Deviation|Mean
2559506|NCT02678000|Secondary|Tmax: Pharmacokinetics of LHW090/LHV527 in Plasma: Time to Reach the Maximum Concentration After Administration of LHW090 (PART 1/PART 2)|The time to reach the maximum concentration after drug administration|Part 1: within 60 minutes prior to dosing, post dose +/- 10 min from greater or equal to 1 hr to 24 hrs. Part 2: within 60 min +/- 10 min from greater or equal to 1 hr to 8 hours after 4 weeks dosing|PK Analysis Set-Subjects with at least one available valid PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data|||hour (hr)||Full Range|Median
2559507|NCT02678000|Secondary|AUC0-t: Pharmacokinetics of LHW090/LHV527 (Active Metabolite)in Plasma: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' Where t is a Defined Time Point After Administration (PART 2)|The area under the plasma concentration-time curve from time zero to 24 hours|PART 2: within 60 min +/- 10 min from greater or equal to 1 hr to 8 hours after 4 weeks dosing|PK Analysis Set -Subjects with at least one available valid PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data|||h* ng/mL||Standard Deviation|Mean
2559508|NCT02678000|Secondary|Cmax : Pharmacokinetics of LHW090/LHV527 (Active Metabolite) in Plasma: Observed Maximum Plasma Concentration Following Administration of LHW090 (PART 1/PART 2)|The observed maximum plasma (or serum or blood) concentration following drug administration for PART 1 and PART 2|PART 1: within 60 minutes prior to dosing, post dose +/- 10 min from greater or equal to 1 hr to 24 hrs. PART 2: within 60 min +/- 10 min from greater or equal to 1 hr to 8 hours after 4 weeks dosing.|PK Analysis Set - Subjects with at least one available valid PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data|||ng / mL||Standard Deviation|Mean
2559509|NCT02678000|Primary|Number of Patients Who Developed a Renal Event (PART 2)|Patients who developed a renal event will be reported (defined as a ≥0.3 mg/dL increase in serum creatinine from baseline within 24-48 hours post dose )|Baseline, within 24 to 48 hours of post-dose weekly for up to 8 weeks|Safety Analysis Set -All subjects that received study drug and with no protocol deviations with relevant impact on safety|||Participants|||Count of Participants
2559510|NCT02678000|Primary|Pharmacokinetics of LHW090/LHV527 (Active Metabolite) in Plasma: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' Where t is a Defined Time Point After Administration (AUC0-t) (PART 1)|The area under the plasma concentration-time curve from time zero to 24 hours. Area Under the Curve (AUC0-t) after 4 days dosing will be reported for PART 1. LHW090 and LHV527 (its active metabolite)|Within 60 minutes prior to dosing, post dose +/- 10 min from greater or equal to 1 hr to 24 hrs.|PK Analysis Set -Subjects with at least one available valid PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data|||h*ng/mL||Standard Deviation|Mean
2559511|NCT02678000|Primary|Number of Patients With Reported Adverse Events Receiving Escalating Doses of LHW090 (Part 1)|Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. For LHW090, incidence of AEs by primary organ class presented|Adverse events were collected from first dose of study treatment until end of study treatment, (12 days dosing period + 9 days follow up (PART 1) plus 30 days post treatment, up to maximum duration of approximately 20 months|Safety Analysis Set -All subjects that received study drug and with no protocol deviations with relevant impact on safety|||Count of Participants|||Number
2559512|NCT02677896|Secondary|Time to Pain Progression Based on Brief Pain Inventory-Short Form (BPI-SF)|Time to pain progression was defined as time from randomization to the first pain progression event. Pain progression was defined as an increase of ≥ 30% from baseline in the average BPI-SF pain severity score. BPI-SF contains 9 questions with rating scales from 0 (no pain/no interference) to 10 (worst pain/interferes completely). Total score was calculated as the average of each question. Higher scores represent a higher level of pain or interference. In participants with no pain progression event, time to pain progression was censored on the last visit date where BPI-SF was collected.|From randomization to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months|ITT|||months||95% Confidence Interval|Median
2559513|NCT02677896|Secondary|Time to Deterioration of Quality of Life (QoL) in Functional Assessment of Cancer Therapy-Prostate (FACT-P)|Time to deterioration of QoL was calculated as the time interval from the date of randomization to the first date a decline from baseline of 10 points or more in the FACT-P total score was recorded. The FACT-P consists of 27 core items that assess participant function in 4 domains and 12 prostate cancer-related items grouped into 5 subscales as follows: physical wellbeing, social/family wellbeing, emotional wellbeing, functional wellbeing and prostate cancer subscale. Each item is rated on a 0 to 4 Likert-type scale. The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0 to 156), where high score represent better quality of life. In participants without FACT-P progression, the time to deterioration of QoL was censored on the date of the last FACT-P total score was calculable.|From randomization to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months|ITT|||months||95% Confidence Interval|Median
2559514|NCT02677896|Secondary|Time to Castration Resistance|Time to castration resistance was calculated as the time from randomization to the first castration-resistant event. A castration resistance event was defined as any of the following in the presence of castrate levels of testosterone (< 50 ng/dL): radiographic disease progression, PSA progression or SSE, whichever occurred first. In participants with no documented castration resistance event, the time to castration resistance was censored on the latest date from: the date of last radiologic assessment, the last PSA sample taken prior to the start of any new prostate cancer therapy and prior to 2 or more consecutive missed PSA assessments (if applicable), and the last visit date performed.|From randomization to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months|ITT|||months||95% Confidence Interval|Median
2559515|NCT02677896|Secondary|Time to First Symptomatic Skeletal Event (SSE)|Time to first SSE was calculated as the time from randomization to the occurrence of the first SSE prior to the data analysis cut-off date. An SSE was defined as radiation to bone, surgery to bone, clinically apparent pathological bone fracture, or spinal cord compression. In participants with no SSE by the time of the data cut-off point, time to SSE was censored on the last visit date or the date of randomization, whichever occurred last.|From randomization to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months|ITT|||months||95% Confidence Interval|Median
2559516|NCT02677896|Secondary|Time to Deterioration in Urinary Symptoms|In participants with deterioration, the time to deterioration was calculated as the time interval between randomization and the first deterioration in urinary symptoms at any postbaseline visit. A deterioration in urinary symptoms was defined as an increase in the Quality of Life Prostate-specific Questionnaire (QLQ-PR25) modified urinary symptoms. Subscale score by ≥ 50% of the standard deviation observed in the QLQ-PR25 modified urinary symptoms subscale score at baseline. Modified urinary symptoms subscale score consisted of 3-items (Q31 - Q33) from the QLQ-PR25, each scored from 1 (not at all) to 4 (very much). The total modified urinary symptoms subscale score ranges from 0-100, with higher scores represents a higher level of symptomatology/problems. In participants without deterioration in urinary symptoms, the time to deterioration in urinary symptoms was censored on the date the last urinary symptoms QLQ-PR25 score was calculable.|From randomization to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months|ITT|||months||95% Confidence Interval|Median
2559517|NCT02677896|Secondary|Objective Response Rate (ORR)|The ORR was calculated as the percentage of participants who achieved a completed response (CR) or a partial response (PR) (unconfirmed responses) in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by ICR.|Up to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months|ITT participants with measurable disease at baseline|||percentage of participants||95% Confidence Interval|Number
2559518|NCT02677896|Secondary|PSA Undetectable Rate|The PSA undetectable rate was defined as the percentage of participants with undetectable (< 0.2 ng/mL) PSA values at any time during study treatment, of those participants with detectable (≥ 0.2 ng/mL) PSA values at baseline.|Up to the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months|ITT with detectable PSA at baseline|||percentage of participants||95% Confidence Interval|Number
2559579|NCT02675907|Secondary|Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 6|Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 6 = 100 * SPID6 / (BaselinePI * 6 * 60), and SPID6 < 0 as an indication for improvement.|6 Hours|ITT Population|||Participants|||Count of Participants
2559519|NCT02677896|Secondary|Time to Start of New Antineoplastic Therapy|In participants with a new antineoplastic therapy initiated for prostate cancer after randomization, time to start of a new antineoplastic therapy was defined as the time interval from randomization to the date of the first dose administration of the first antineoplastic therapy. In participants with no new antineoplastic therapy initiated for prostate cancer after randomization, time to start of new antineoplastic therapy was censored on the last visit date or the date of randomization, whichever occurred last.|From randomization until the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months|ITT|||months||95% Confidence Interval|Median
2559520|NCT02677896|Secondary|Time to Prostate Specific Antigen (PSA) Progression|Time to PSA progression was calculated as the time from the date of randomization to the first observation of PSA progression. A PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir, which was confirmed by a second consecutive value at least 3 weeks later. In participants with no PSA progression, time to PSA progression was censored on the date of the last PSA sample taken (or last value prior to 2 or more consecutive missed PSA assessments).|From randomization until the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months|ITT|||months||95% Confidence Interval|Median
2559521|NCT02677896|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. In participants still alive at the date of the analysis cutoff point, OS was censored on the last date the participant was known to be alive.|Up to 78 months||2023-11-30|11/2023||||
2559522|NCT02677896|Primary|rPFS Based on ICR of Bone Scan According to Protocol Assessment Criteria|"rPFS was calculated as the time from the date of randomization to the first objective evidence of radiographic progression disease (rPD) at any time or death up to 24 weeks after study drug discontinuation without documented radiographic progression, whichever occurred first. rPD was defined as progressive disease by Response Evaluation Criteria in Solid Tumors version 1.1 for soft tissue disease or by appearance of 2 or more new lesions on bone scan compared to baseline for week 13 or the best response on treatment for week 25 or later assessments, as assessed by ICR or death. In participants with no rPFS event, rPFS was censored on the date of last evaluable radiographic assessment prior to the data analysis cutoff date. In participants with no baseline radiographic assessment, participants with no postbaseline radiographic assessments and participants with all postbaseline radiographic assessments documented as not evaluable (NE), rPFS was censored on the date of randomization."|From randomization until the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months.|ITT|||months||95% Confidence Interval|Median
2559523|NCT02677896|Primary|Radiographic Progression-Free Survival (rPFS) Based on Independent Central Review (ICR) of Bone Scan According to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Criteria|"rPFS was calculated as the time from the date of randomization to the first objective evidence of radiographic progression disease (rPD) at any time or death up to 24 weeks after study drug discontinuation without documented radiographic progression, whichever occurred first. rPD was defined as progressive disease by Response Evaluation Criteria in Solid Tumors version 1.1 for soft tissue disease or by appearance of 2 or more new lesions on bone scan compared to baseline or week 13 according to PCWG2 criteria, as assessed by ICR or death. In participants with no rPFS event, rPFS was censored on the date of last evaluable radiographic assessment prior to the data analysis cutoff date. In participants with no baseline radiographic assessment, participants with no postbaseline radiographic assessments and participants with all postbaseline radiographic assessments documented as not evaluable (NE), rPFS was censored on the date of randomization."|From randomization until the data cut-off date of 14 October 2018; maximum duration of treatment was 26.6 months|ITT population is defined as all participants who were randomized in this study.|||months||95% Confidence Interval|Median
2559524|NCT02677844|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Loperamide|Blood samples were collected from participants in Cohort 2 Period 4 (DDI) to determine plasma concentrations of Loperamide.|Day -3: Predose,1, 2, 4, 6, 8, 12, 14, 24, and 48 hours postdose;Day 1 predose, (-0.25 hours), and Day1: 1, 2, 4, 6, 8, 10, 12, 14, 24, 48, and 72 hours Post Dose|All randomized participants in Cohort 2 Period 4 (DDI) who received Loperamide & had evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2559525|NCT02677844|Secondary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point With Measurable Concentration [AUC(0-tlast)] of Loperamide|Blood samples were collected from participants in Cohort 2 Period 4 (DDI) to determine plasma concentrations of Loperamide.|Day -3: Predose, 1, 2, 4, 6, 8, 12, 14, 24, and 48 hours postdose;Day 1 predose, (-0.25 hours), and Day1: 1, 2, 4, 6, 8, 10, 12, 14, 24, 48, and 72 hours Post Dose|All randomized participants in Cohort 2 Period 4 (DDI) who received Loperamide & had evaluable PK data.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2559526|NCT02677844|Secondary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Last Time Point With Measurable Concentration AUC(0-tlast) of Abemaciclib|Blood samples were collected from participants in Cohort 1(all periods) and Cohort 2 (Periods 5, 6, and 7) to determine the plasma concentrations of Abemaciclib 0-tlast.|Day 1: 2, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, and 120 hours Post Dose|All randomized participants who received at least one dose of study drug in Cohort 1 all periods & Cohort 2 periods 5,6, and 7 with evaluable PK data.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2559527|NCT02677844|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib|Blood samples were collected from participants in Cohort 1(all periods) and Cohort 2 (Periods 5, 6, and 7) to determine the plasma concentrations of Abemaciclib.|Day 1: 2, 4, 6, 8, 10, 12, 14, 24, 48, 72, 96, and 120 hours Post Dose|All randomized participants who received at least one dose of study drug in Cohort 1 all periods & Cohort 2 periods 5,6, and 7 with evaluable PK data.|||Nanogram per Milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2559528|NCT02677844|Primary|Mean Time Matched Placebo-Adjusted Changes From Baseline For Fridericia's Corrected QT Interval (ΔΔQTcF)|"QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data. ECG monitoring was conducted using a 12-lead digital Holter recorder from approximately 2 hours predose through 24 hours postdose on Day 1 of each period using 12-lead digital Holter recorder.~Fridericia-corrected QT interval (QTcF): QTcF = QT/RR1/3, where RR is the interval between two R waves."|Day 1: 2hr,4hr,6hr,8hr,10hr,12hr,14hr,24hr Post Dose|All randomized participants who received at least one dose of study drug and had baseline and post baseline QTcF values.|||Millisecond (msec)||90% Confidence Interval|Mean
2559534|NCT02677766|Primary|Change From Baseline to Follow-up of the Performance Score at the Canadian Occupational Performance Measure|"The Canadian Occupational Performance Measure is a valid, evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time.~The score is between 1 and 10, where 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction"|T0 is the baseline at the patient ammission in the rehabilitation Ward; T2 is the follow-up at end of the intervention, 45 days ± 15 days from discharge||||units on a scale||Standard Deviation|Mean
2559535|NCT02677740|Primary|Percent Change of Functional Connectivity in Right Motor Cortex, Where Functional Connectivity is Measured as a Dimensionless Fractional Amplitude of Low-frequency Fluctuations (fALFF), at 80 Min After rTMS|Functional connectivity is measured with MRI at 7 Tesla as a dimensionless fractional amplitude of low-frequency fluctuations (fALFF). This is an index which reflects the intensity of spontaneous regional brain activity. It is calculated as the ratio of power spectra of low frequency (0.01-0.08 Hz) to that of the entire frequency range. Percent change of functional connectivity is calculated from baseline (i.e., pre-rTMS).|Baseline/Pre-rTMS and 80 min after rTMS||||percent change||Standard Deviation|Mean
2559536|NCT02677740|Primary|Percent Change of Functional Connectivity in Left Motor Cortex, Where Functional Connectivity is Measured as a Dimensionless Fractional Amplitude of Low-frequency Fluctuations (fALFF), at 80 Min After rTMS|Functional connectivity is measured with MRI at 7 Tesla as a dimensionless fractional amplitude of low-frequency fluctuations (fALFF). This is an index which reflects the intensity of spontaneous regional brain activity. It is calculated as the ratio of power spectra of low frequency (0.01-0.08 Hz) to that of the entire frequency range. Percent change of functional connectivity is calculated from baseline (i.e., pre-rTMS).|Baseline/Pre-rTMS and 80 min after rTMS||||percent change||Standard Deviation|Mean
2559537|NCT02677740|Primary|Percent Change of GABA Concentration in a Voxel Encompassing the Right Motor Cortex, Measured at 60 Min After rTMS|GABA concentration is quantified with MRS at 7 Tesla. Percent change of GABA concentration is calculated from baseline (i.e., pre-rTMS).|Baseline/Pre-rTMS and 60 min after rTMS||||percent change||Standard Deviation|Mean
2559538|NCT02677740|Primary|Percent Change of GABA Concentration in a Voxel Encompassing the Left Motor Cortex, Measured at 30 Min After rTMS|GABA concentration is quantified with MRS at 7 Tesla. Percent change of GABA concentration is calculated from baseline (i.e., pre-rTMS).|Baseline/Pre-rTMS and 30 min after rTMS||||percent change||Standard Deviation|Mean
2559539|NCT02677623|Primary|Visual Analog Scale (VAS)|"This is a 10-cm visual analog scale to determine which method of evaluating ureteral patency is most satisfactory to physicians. The smiley face is at one end and the frowning face is at the other end. Smiling is 1 and frowning is 10. The scale is completed by surgeon, anesthesiologist and the circulator by placing an x or a mark anywhere on the 10 cm line towards how good and or bad each person felt about the of process of patency assessment that was used. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from a minimum of 0 to a maximum of 100. A higher score indicates greater pain intensity (worse outcome)."|Intraoperative|Inclusion criteria stipulated women age >18 years who desired elective, scheduled gynecologic or urogynecologic surgery. Women were excluded if they were pregnant; had a known urologic anatomical anomaly; or had a history of adverse reaction or contraindication to use of phenazopyridine, sodium fluorescein, or mannitol.|||score on a scale||Full Range|Median
2559540|NCT02677493|Secondary|Geometric Mean Ratio as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.||Day 28|||||||
2559541|NCT02677493|Secondary|Geometric Mean Titer as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.||Day 28|||||||
2559542|NCT02677493|Secondary|Difference in Seroconversion Rate(SCRcomparator-SCRtest Vaccine)||Day 28|||||||
2559543|NCT02677493|Secondary|Geometric Mean Titer as Measured by HI Antibody Titer on Day 28 After Vaccination of the Investigational Product (GMTcomparator/GMTtest Vaccine).||Day 28|||||||
2559544|NCT02677493|Secondary|Rate of Healthy Adults Aged ≥19 ~ <65 Years and ≥65 Years With Seroprotection, Respectively.|Seroprotection is defined as follows. subjects who have a post-vaccination (Day 28) HI antibody titer ≥ 1: 40|Day 28|||||||
2559545|NCT02677493|Secondary|Rate of Healthy Adults Aged ≥19 ~ <65 Years and ≥65 Years With Seroconversion, Respectively.|Seroconversion is defined as follows. (Case 1) A pre-vaccination (Day 0) HI antibody titer < 1:10 and a post-vaccination (Day 28) HI antibody titer ≥ 1: 40. or (Case 2) a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer.|Day 28|||||||
2559546|NCT02677493|Primary|Rate of Healthy Adults Aged ≥19 Years With Seroprotection|Seroprotection: A post-vaccination (Day 28) HI antibody titer ≥ 1:40.|Day 28|The immunogenicity data obtained from the study subjects were analyzed primarily in the Per Protocol Set that was consists of subjects who had at least one dose of the investigational product and from whom post-treatment primary efficacy endpoint data, and have completed the study up to Visit 3 without a major protocol violation.|||percentage of subjects||95% Confidence Interval|Number
2559547|NCT02677493|Primary|Rate of Healthy Adults Aged ≥19 Years With Seroconversion|Seroconversion is defined as follows. (Case 1) A pre-vaccination (Day 0) HI antibody titer < 1:10 and a post-vaccination (Day 28) HI antibody titer ≥ 1: 40. or (Case 2) a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer.|Day 28|The immunogenicity data obtained from the study subjects were analyzed primarily in the Per Protocol Set that was consists of subjects who had at least one dose of the investigational product and from whom post-treatment primary efficacy endpoint data, and have completed the study up to Visit 3 without a major protocol violation.|||percentage of subjects||95% Confidence Interval|Number
2559548|NCT02677220|Secondary|Speech, Spatial, and Qualities of Hearing Scale|The Speech Spatial and Qualities of Hearing Scale (SSQ) is a subjective measure of satisfaction. Change is reflected in a gain in scores pre- to post-operatively (-10 to +10).|6 months post-activation|subject did not reach endpoint - SSQ was not collected at 3 months per protocol||||||
2559549|NCT02677220|Secondary|Glasgow Benefit Inventory|The Glasgow Benefit Inventory (GBI) is a health utility assessment used at six months post-operatively. Performance benefits are a change in score from pre- to post-operatively, scored from -100 to +100.|6 months post-activation|subject did not reach endpoint - GBI was not collected at 3 months per protocol||||||
2559550|NCT02677220|Primary|AzBio Sentence Recognition in Noise|The AzBio Sentence test was recorded at 3 months prior to subject withdraw. Not collected at endpoint. AzBio Tests consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score and the resulting score is presented in percent correct.|3 months post-activation||||percent correct||Standard Deviation|Mean
2559551|NCT02676895|Secondary|Number of Subjects With Titers Post Vaccination Concentration for Anti-LPS S. Sonnei ≥ 121 U/mL|The analysis cut-off value (121 U/mL) was expressed in units per milliliter (U/mL), as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA).|At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)|This analysis was performed on the Full Analysis Set, including subjects with at least 1 dose of study vaccine administered. Numbers decreased over time, hence at study Visit 5 (Day 57), not all subjects from study Visit 1 (Day 1) had available immunogenicity results.|||Participants|||Count of Participants
2559552|NCT02676895|Secondary|Number of Subjects With Seroresponse to Anti-LPS S. Sonnei IgG ELISA, by Baseline Titer|"Seroresponse was defined as: if the baseline value was greater than 50 EU then an increase of at least 50% in the post-vaccination sample as compared to baseline (i.e., [{post-vac minus baseline}/baseline]100% ≥ 50%); if the baseline value was less or equal to 50 EU then an increase of at least 25 EU in the post-vaccination sample as compared to baseline (i.e., [post-vac minus baseline] ≥ 25 EU).~Since all subjects in the study were from an endemic country, they had pre-vaccination titers equal to or above (≥) LLOQ (limit of detection)."|At Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)|This analysis was based on the Full Analysis Set, including subjects with at least 1 dose of study vaccine administered. Some subjects were excluded due to implausible values from all study visits.|||Participants|||Count of Participants
2559553|NCT02676895|Secondary|Anti-LPS S. Sonnei Geometric Mean Ratios (GMRs) Between Post- and Pre-vaccination Samples|The ratio was expressed as unadjusted geometric mean ratio (GMR) and presented with its 95% confidence interval (CI).|At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)|This analysis was performed on the Full Analysis Set, including subjects with at least 1 dose of study vaccine administered. Numbers decreased over time, hence at study Visit 5 (Day 57), not all subjects from study Visit 1 (Day 1) had available immunogenicity results.|||Geometric mean ratio||95% Confidence Interval|Geometric Mean
2559554|NCT02676895|Secondary|Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer|Anti-LPS S.Sonnei IgG ELISA concentrations were tabulated as unadjusted geometric mean concentrations (GMCs) and expressed as ELISA units (EU) per milliliter (mL), presented with their 95% confidence intervals (CIs). Since all subjects in the study were from an endemic country, they had pre-vaccination titers equal to or above (≥) LLOQ (limit of detection).|At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)|This analysis was performed on the Full Analysis Set, including subjects with at least 1 dose of study vaccine administered. Numbers decreased over time, hence at study Visit 5 (Day 57), not all subjects from study Visit 1 (Day 1) had available immunogenicity results.|||EU/mL||95% Confidence Interval|Geometric Mean
2559555|NCT02676895|Primary|Number of Subjects With Reported Reactive Arthritis or Neutropenia (AESIs)|"Reactive arthritis is defined as non-purulent joint inflammation that develops in response to an infection in another part of the body. Since the inflammation is triggered by a previous condition, it is termed reactive. Intestinal pathogens that have been associated with reactive arthritis include Campylobacter, Salmonella, Yersinia, Clostridium difficile, and Shigella. If reactive arthritis is caused by an auto immune response, there is at least a possibility that it could be initiated by vaccination of susceptible people with the 1790GAHB vaccine."|Throughout the whole study period (from Day 1 up to Day 57)|This analysis was performed on the Unsolicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom unsolicited adverse event data were available.|||Participants|||Count of Participants
2559556|NCT02676895|Primary|Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges|The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase [ALP], Alanine Aminotransferase [ALA], Aspartate Aminotransferase [AST], Bilirubin [BILI], Blood Urea Nitrogen [BUN], Creatinine [CREAT], Gamma Glutamyl Transferase [GGT], Glucose [GLUC], Potassium [K], Lactate Dehydrogenase [LDH] and Sodium [Na]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.|At Day 57 (28 days after the second vaccination)|This analysis was performed on the Overall Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited and/or unsolicited adverse event data were available. Less subjects were available with each subsequent visit, hence the number of subjects analysed is lower than in the previous timepoints.|||Participants|||Count of Participants
2559557|NCT02676895|Primary|Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges|The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase [ALP], Alanine Aminotransferase [ALA], Aspartate Aminotransferase [AST], Bilirubin [BILI], Blood Urea Nitrogen [BUN], Creatinine [CREAT], Gamma Glutamyl Transferase [GGT], Glucose [GLUC], Potassium [K], Lactate Dehydrogenase [LDH] and Sodium [Na]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.|At Day 36 (7 days after the second vaccination)|This analysis was performed on the Overall Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited and/or unsolicited adverse event data were available. Less subjects were available with each subsequent visit, hence the number of subjects analysed is lower than in the previous timepoints.|||Participants|||Count of Participants
2559558|NCT02676895|Primary|Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges|"The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase [ALP], Alanine Aminotransferase [ALA], Aspartate Aminotransferase [AST], Bilirubin [BILI], Blood Urea Nitrogen [BUN], Creatinine [CREAT], Gamma Glutamyl Transferase [GGT], Glucose [GLUC], Potassium [K], Lactate Dehydrogenase [LDH] and Sodium [Na]).~Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter."|At Day 29 (28 days after the first vaccination)|This analysis was performed on the Overall Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited and/or unsolicited adverse event data were available. Less subjects were available with each subsequent visit, hence the number of subjects analysed is lower than in the previous timepoints.|||Participants|||Count of Participants
2559559|NCT02676895|Primary|Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges|"The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase [ALP], Alanine Aminotransferase [ALA], Aspartate Aminotransferase [AST], Bilirubin [BILI], Blood Urea Nitrogen [BUN], Creatinine [CREAT], Gamma Glutamyl Transferase [GGT], Glucose [GLUC], Potassium [K], Lactate Dehydrogenase [LDH] and Sodium [Na]).~Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter."|At Day 8 (7 days after first vaccination)|This analysis was performed on the Overall Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited and/or unsolicited adverse event data were available. Less subjects were available with each subsequent visit, hence the number of subjects analysed is lower than in the previous timepoints.|||Participants|||Count of Participants
2559560|NCT02676895|Primary|Number of Subjects With Serious Adverse Events (SAEs)|An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; is life-threatening (i.e., the subject was, in the opinion of the investigator, at immediate risk of death from the event as it occurred); it does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions); congenital anomaly/or birth defect; an important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.|Throughout the whole study period (from Day 1 up to Day 57)|This analysis was performed on the Unsolicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom unsolicited adverse event data were available.|||Participants|||Count of Participants
2559561|NCT02676895|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|"An unsolicited AE is an AE that was not solicited using the Diary Card and that was spontaneously communicated by a subject who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject.~Note: *disruptions= dose reduction, interruption or delay in study vaccination."|During 28 days following each vaccination|This analysis was performed on the Unsolicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom unsolicited adverse event data were available.|||Participants|||Count of Participants
2559562|NCT02676895|Primary|Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination|Assessed solicited local adverse reactions were injection site erythema, induration, pain. Assessed systemic adverse reactions were headache, arthralgia, chills, fatigue, malaise, myalgia and temperature (body temperature measured axillary). Any = occurrence of the symptom regardless of intensity grade. Any temperature = body temperature ≥ 38.0°C. Severe symptom = pain, headache, arthralgia, chills, fatigue, malaise and myalgia that prevented normal activity. Severe redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Severe temperature = body temperature > 40.0 °C.|From 30 minutes up to 7 days following each vaccination|This analysis was performed on the Solicited Safety Set, which included all enrolled subjects who received a study vaccination and for whom solicited adverse event data were available. Less subjects were available to receive the second dose, hence the number or participants analysed is lower for the second dose results.|||Participants|||Count of Participants
2559563|NCT02676882|Primary|Rate of Treatment Response Among Depressed Participants (Group 2) to EnBrace Therapy Measured Using the Montgomery Asberg Depression Rating Scale|Experience a response (50% improvement in depressive symptoms) to EnBrace therapy, as assessed by the Montgomery Asberg Depression Rating Scale (MADRS). The MADRS is a 10-item scale assessing the presence and severity of depressive symptoms, each with a score of 0-6 in which 0 denotes absence of a given symptom and 6 denotes the highest burden, frequency, or severity of a given symptom. The total score (sum of 10 items) ranges from 0-60 points, with scores of </=10 considered clinically well and scores of >/=15 considered clinically depressed for this study. Symptoms assessed include reported and apparent sadness, inner tension, reduced sleep, reduced appetite, concentration difficulty, lassitude, anhedonia, pessimistic thoughts, and suicidality.|Assessed every two weeks for 12 weeks|Of the 7 women eligible for inclusion in Group 2, 1 did not initiate study medication and dropped from the study after baseline. The 6 other women were evaluable as they returned for follow-up visits.|||Participants|||Count of Participants
2559580|NCT02675907|Secondary|Time to Meaningful Pain Relief (TTMPR)|Time to perceptible and meaningful pain relief was measured using the double stopwatch method. For each randomized subject, two stopwatches were started immediately after administration of the first study dose (Hour 0). The subject was to stop the first watch when they first perceived pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they first experienced meaningful pain relief (time to meaningful relief).|12 Hours|ITT Population|||hours||95% Confidence Interval|Median
2559564|NCT02676882|Primary|Number of Participants in the Relapse-Prevention Group (Group 1) Experiencing a Major Depressive Episode Relapse|Evidence of recurrence of major depression episode, as defined by the Mini-International Neuropsychiatric Interview (MINI) mood module and/or research clinician interview. The MINI is a brief, validated structured clinical interview used for diagnostic purposes for DSM-IV and ICD-10 psychiatric disorders in clinical trials. The interview is performed by a licensed study physician and takes about 15 minutes. The MINI is divided into modules corresponding to diagnostic categories, and questions are answered as a binary yes or no by the research subject. The MINI mood module in this case refers to the set of questions examining major depressive disorder symptoms to identify if a patient is experiencing depressive symptoms that meet criteria as a major depressive episode.|Assessed every two weeks for 12 weeks|Those women in group 1 who discontinued antidepressants (ADs) during the study (2 women of 13 in group 1 planned to discontinue ADs when they became pregnant and were actively trying to conceive, but they did not become pregnant during the trial and did not decrease the dose of their ADs).|||Participants|||Count of Participants
2559565|NCT02676843|Primary|SUVR of 18F-AV-1451|Regional tau deposition will be measured as standardized uptake value ratio (SUVR) of 18F-AV-1451. SUVR (80-100 min post-injection) for 18F-AV-1451 will be calculated two ways: 1) using cerebellar crus as a reference region, and 2) using the Parametric Estimation of Reference Signal Intensity (PERSI) method to create individual white matter reference regions. Binding in the inferior temporal lobe/cortex was used as the primary outcome.|Baseline, 12-month follow up|5 out of 7 subjects had data collected and analyzed (evaluable repeat imaging after 12 months).|||standardized uptake value ratio (SUVR)||Full Range|Median
2559566|NCT02676466|Secondary|Short Form Health Survey (SF-36) - Physical Component Score|The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Range: 0-100. A lower score indicates more disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|month 12||||score on a scale||Standard Deviation|Mean
2559567|NCT02676466|Secondary|Peak Torque of the Knee Extensor and Flexor Muscles|Peak torque was measured at a rotational speed of 60 degrees per second using a commercially-available Isokinetic Dynamometer (Biodex). Torque was measured during maximal knee extension and flexion reported in Newton Meters.|month 12||||Newton meters||Standard Deviation|Mean
2559568|NCT02676466|Secondary|Isometric Hand Grip Strength|The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles. Scoring will be taken from the best results of 3 trials. Males scores range from 88 pounds as very poor to 141 pounds as excellent with an average of 105-113 pounds. Females scores range from 44 pounds as very poor to 84 pounds as excellent with an average of 57-65 pounds.|12 months||||pounds||Standard Deviation|Mean
2559569|NCT02676466|Secondary|Number of Participants Exhibiting Frailty|Frailty will be characterized with Fried criteria developed by Fried et al. that employ self-reported exhaustion, unintentional weight loss, low energy expenditure, slow gait speed, and weak grip strength. Those with >3 of the 5 factors are judged to be frail, those with 1 or 2 factors as pre-frail, and those with no factors as non-frail.|12 months||||Participants|||Count of Participants
2559570|NCT02676466|Secondary|Short Physical Performance Battery (SPPB)|A low score on the SPPB based on 4 m walk, balance & chair stands tests is a risk factor for disability, institutionalization, morbidity and mortality in initially non-disabled older persons. The summary score and components of the SPPB have good reliability (ICCs range from 0.88 to 0.92). Higher scores are better. Range 0-12.|12 months||||units on a scale||Standard Deviation|Mean
2559571|NCT02676466|Primary|Number of Participants Experiencing Major Mobility Disability|The 400 meter walk test at usual pace is used to evaluate major mobility disability (MMD), defined as the inability to walk ¼ mile or 400 meters.|12 months||||Participants|||Count of Participants
2559572|NCT02676466|Primary|Changes in the Interleukin-6 Level Between Groups|Changes in the Interleukin-6 Level Between the Groups|Changes from baseline to month 12||||pg/ml||Standard Deviation|Mean
2559573|NCT02676375|Primary|Exhaled Carbon Monoxide (CO) as Parts Per Million (PPM)|Weekly measurements of expired carbon monoxide in the units of parts per million (PPM) participants to evaluate abstinence from smoking (a value equal to or less than 3 PPM is considered abstinent).|Measured week 0, 12, and 26||||ppm||Standard Deviation|Mean
2559574|NCT02675907|Secondary|Patient Global Assessment (PGA) of Pain Control at Hour 48|PGA of pain control was evaluated at Hour 24 and Hour 48 with subject reported degree of pain control over the preceding interval according to a 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent.|48 Hours||||Participants|||Count of Participants
2559575|NCT02675907|Secondary|Patient Global Assessment (PGA) of Pain Control at Hour 24|PGA of pain control was evaluated at Hour 24 and Hour 48 with subject reported degree of pain control over the preceding interval according to a 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent.|24 Hours||||Participants|||Count of Participants
2559576|NCT02675907|Secondary|Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 24|Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 24 = 100 * SPID24 / (BaselinePI * 24 * 60), and SPID24 < 0 as an indication for improvement.|24 Hours|ITT Population|||Participants|||Count of Participants
2559577|NCT02675907|Secondary|Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 6|Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 6 = 100 * SPID6 / (BaselinePI * 6 * 60), and SPID6 < 0 as an indication for improvement.|6 Hours|ITT Population|||Participants|||Count of Participants
2559578|NCT02675907|Secondary|Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 24|Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 24 = 100 * SPID24 / (BaselinePI * 24 * 60), and SPID24 < 0 as an indication for improvement.|24 Hours|ITT Population|||Participants|||Count of Participants
2559581|NCT02675907|Secondary|Time to Perceptible Pain Relief (TTPPR)|Time to perceptible and meaningful pain relief was measured using the double stopwatch method. For each randomized subject, two stopwatches were started immediately after administration of the first study dose (Hour 0). The subject was to stop the first watch when they first perceived pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they first experienced meaningful pain relief (time to meaningful relief).|12 Hours|ITT Population|||hours||95% Confidence Interval|Median
2559582|NCT02675907|Secondary|Number of Doses of Rescue Analgesia Utilized Per Subject|Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.|48 Hours|ITT Population|||doses of rescue analgesia||Standard Error|Least Squares Mean
2559583|NCT02675907|Secondary|Number of Subjects Utilizing Rescue Analgesia|Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.|48 Hours|ITT Population|||Participants|||Count of Participants
2559584|NCT02675907|Secondary|Time to First Dose of Rescue Analgesia|Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request. Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.|48 Hours|ITT Population|||hours||95% Confidence Interval|Median
2559585|NCT02675907|Secondary|Summed Pain Intensity Difference (SPID) at Other Intervals|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.|48 Hours|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2559586|NCT02675907|Primary|Summed Pain Intensity Difference Over the First 48 Hours (SPID48)|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.|48 Hours|Intent-to-Treat (ITT) population|||units on a scale||Standard Error|Least Squares Mean
2559587|NCT02675764|Primary|WMFT at Least 2 Weeks After the 2-week Intervention|change in hand motor function as measured by the Wolf Motor Function Test hand items time. This test measures time to complete movements in seconds. More negative values represent greater reduction in time and thus better outcomes.|follow up (2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)||||change in ln(sec)||Standard Error|Mean
2559588|NCT02675764|Primary|WMFT About a Week After the 2-week Intervention|change in hand motor function as measured by the Wolf Motor Function Test hand items time. This test measures time to complete movements in seconds. More negative values represent greater reduction in time and thus better outcomes.|post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy)||||change in ln(sec)||Standard Error|Mean
2559589|NCT02675764|Primary|Box and Block Test (BBT) at Least 2 Weeks After the 2-week Intervention|Change in hand motor function as measured by the Box and Block Test. This test measures the number of blocks that a participant moved in a minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.|follow up (at least 2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)||||change in # of blocks||Standard Error|Mean
2559590|NCT02675764|Primary|Box and Block Test (BBT) About a Week After the 2-week Intervention|Change in hand motor function as measured by the Box and Block Test. This test measures the number of blocks that a participant moved in a minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.|post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy)||||change in # of blocks||Standard Error|Mean
2559591|NCT02675751|Primary|The Percentage of Eyes Achieving the Target of Monocular Uncorrected Visual Acuity of 20/40 or Better|At 6 months, UCVA of 20/40 was achieved in 100% (324/324) of eyes monocularly.|6 months|Of the 334 eyes (167 subjects) treated in the study, 324 eyes (162 subjects) were available at 6 months for analysis.|||Eyes|Eyes||Count of Units
2559592|NCT02675634|Primary|Fit to Body|"Subjects will evaluate the fit to body for each product by answering the question how was the baseplates ability to fit the body contours in the area around the stoma? The question is answered using an ordinal 5 point scale ranging from very poor to very good. The result shown below shows the fraction of subject who answered 'Good' or' Very Good' to the question."|14 +/- 2 days||||percentage of good or very good|||Number
2559593|NCT02675543|Primary|Vitreous Prostaglandin E2 Levels||intraoperarive||||pg/mL||Standard Deviation|Mean
2559594|NCT02675517|Secondary|Patient Satisfaction With Handling of the Respimat® Inhalation Device at Week 6 (Approx.) (Visit 2).|At Week 6 (approx.) (Visit 2) patients were asked how satisfied they were with handling of the Respimat® inhalation device|Week 6 (approx.) (Visit 2)|FAS|||percentage of participants|||Number
2559595|NCT02675517|Secondary|Patient Satisfaction With Inhaling From the Respimat® Device at Week 6 (Approx.) (Visit 2).|At Week 6 (approx.) (Visit 2) patients were asked how satisfied they were by inhaling with the Respimat® device.|Week 6 (approx.) (Visit 2)||||percentage of participants|||Number
2559596|NCT02675517|Secondary|Patient Overall Satisfaction With Spiolto® Respimat® at Week 6 (Approx.) (Visit 2).|At Week 6 (approx.) (Visit 2) patients were asked how overall satisfied they were with the Spiolto® Respimat® treatment.|Week 6 (approx.) (Visit 2)|FAS|||Percentage of participants|||Number
2561391|NCT02650921|Secondary|Question 2 From Subject Satisfaction Questionnaire|Question 2: My treated hand appears more attractive than my untreated hand|Week 12|ITT|||Participants|||Count of Participants
2559599|NCT02675517|Primary|Percentage of Patients With Therapeutic Success at Week 6 (Approx.) (Visit 2).|"Therapeutic success defined as a minimum 10-point increase of Physical functioning questionnaire (PF-10 ) score after approximately 6 weeks of Spiolto® Respimat® treatment The PF-10 used for assessing the primary outcome physical functioning is a sub-domain of the validated Short Form 36 (SF-36) quality of life questionnaire and consists of 10 questions evaluating the extent of experienced restrictions while conducting usual activities. The total score ranges from 0 to 100. A higher score indicates a better physical functioning."|after approximately 6 weeks|Full analysis set (FAS): This analysis set consist of all screened patients with informed consent, date of registration, at least one documented administration of Spiolto® Respimat® & available PF-10 score at visit 1&2, & confirmed main diagnosis of COPD in whom treatment with long-acting anticholinergics plus bronchodilators is indicated.|||Percentage of patients||95% Confidence Interval|Number
2559600|NCT02675426|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 1|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:~≥ 20% improvement in 68-tender joint count;~≥ 20% improvement in 66-swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and week 1|Full analysis set; participants who prematurely discontinued from study drug prior to week 1 or for whom ACR data were missing at week 1 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2559601|NCT02675426|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:~≥ 70% improvement in 68-tender joint count;~≥ 70% improvement in 66-swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and week 12|Full analysis set; participants who prematurely discontinued from study drug prior to week 12 or for whom ACR data were missing at week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2559602|NCT02675426|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:~≥ 50% improvement in 68-tender joint count;~≥ 50% improvement in 66-swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and week 12|Full analysis set; participants who prematurely discontinued from study drug prior to week 12 or for whom ACR data were missing at week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2559603|NCT02675426|Secondary|Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)|The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.|Baseline and week 12|Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to week 12 was used.|||units on a scale||95% Confidence Interval|Least Squares Mean
2559604|NCT02675426|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 12|Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days.|Baseline and week 12|Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to week 12 was used.|||minutes||95% Confidence Interval|Least Squares Mean
2559605|NCT02675426|Secondary|Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12|"Low disease activity based on the clinical disease activity index (CDAI) is defined as a CDAI score ≤ 10.~CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity."|Week 12|Full analysis set; participants who prematurely discontinued from study drug prior to week 12 or for whom CDAI data were missing at week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2559606|NCT02675426|Secondary|Percentage of Participants Achieving Clinical Remission Based on DAS28 (CRP) at Week 12|"Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6.~DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity."|Week 12|Full analysis set; participants who prematurely discontinued from study drug prior to week 12 or for whom DAS28 (CRP) data were missing at week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2559621|NCT02674659|Primary|PCSK-9 Level|this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program. The method that we use to check PCSK-9 level is ELISA method|3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)|Patients who completed the cardiac rehabilitation program|||ng/ml||Standard Deviation|Mean
2559622|NCT02674568|Secondary|Number of Participants With TEAEs Occurring in at Least 10% of All Participants During Initial Treatment|TEAEs were defined as AEs that were newly occurring or worsened following study treatment.|From first dose of study drug through the end of the initial treatment period (84 ± 6 days)|Safety analysis population: all participants who received any amount of study drug.|||Participants|||Count of Participants
2559607|NCT02675426|Secondary|Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12|"The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).~The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement."|Baseline and Week 12|Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to week 12 was used.|||units on a scale||95% Confidence Interval|Least Squares Mean
2559608|NCT02675426|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12|"The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.~A negative change from Baseline in the overall score indicates improvement."|Baseline and week 12|Full analysis set participants with available data at baseline; multiple imputation was used for missing data.|||units on a scale||95% Confidence Interval|Least Squares Mean
2559609|NCT02675426|Secondary|Change From Baseline in in Disease Activity Score 28 (CRP) at Week 12|The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline in DAS28 (CRP) indicates improvement in disease activity.|Baseline and week 12|Full analysis set participants with available data at baseline; multiple imputation was used for missing data.|||units on a scale||95% Confidence Interval|Least Squares Mean
2559610|NCT02675426|Primary|Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12|"The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was low disease activity, based on a Disease Activity Score 28 (DAS28)-CRP score of ≤ 3.2 at week 12.~The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.~A DAS28 score less than or equal to 3.2 indicates low disease activity."|Week 12|Full analysis set; participants who prematurely discontinued from study drug prior to week 12 or for whom DAS28 data were missing at week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2559611|NCT02675426|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12|"The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) at Week 12. Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:~≥ 20% improvement in 68-tender joint count;~≥ 20% improvement in 66-swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and week 12|Full analysis set; participants who prematurely discontinued from study drug prior to week 12 or for whom ACR data were missing at week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2559612|NCT02674854|Primary|Intraocular Pressure (IOP)|Mean intraocular pressure(IOP) at 08:00, 10:00 and 16:00 hours, at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry.|3 months|Intent to treat (ITT) population with Monte Carlo Markov Chain (MCMC) imputation|||mmHg||Standard Deviation|Mean
2559613|NCT02674659|Secondary|Diastolic Blood Pressure|this outcome measurement will be achieved by taking the patient's blood pressure after cardiac rehabilitation program|3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)||||mmHg||Standard Deviation|Mean
2559614|NCT02674659|Secondary|Systolic Blood Pressure|this outcome measurement will be achieved by taking the patient's blood pressure after cardiac rehabilitation program|3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)||||mmHg||Standard Deviation|Mean
2559615|NCT02674659|Secondary|Fasting Blood Glucose|Blood glucose concentration was taken after 10-12-hour fasting. This outcome measurement will be achieved by taking the patient's blood sample after cardiac rehabilitation program|3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)||||mg/dL||Standard Deviation|Mean
2559616|NCT02674659|Secondary|Triglyceride|This outcome measurement will be achieved by taking the patient's blood sample after cardiac rehabilitation program|3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)||||mg/dL||Standard Deviation|Mean
2559617|NCT02674659|Secondary|Total Cholesterol|this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program|3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)||||mg/dL||Standard Deviation|Mean
2559618|NCT02674659|Secondary|High-Density Lipoprotein|this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program|3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)||||mg/dL||Standard Deviation|Mean
2559619|NCT02674659|Secondary|Body Mass Index|Body Mass Index is calculated by calculating the measured body weight divided by the height square in measure. We take BMI data after cardiac rehabilitation program in every participant.|3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)||||kg/m^2||Standard Deviation|Mean
2559620|NCT02674659|Secondary|Low Density Lipoprotein|this outcome measurement will be achieved by taking patient's blood sample after cardiac rehabilitation program|3-4 weeks (after completion of 12 sessions of cardiac rehabilitation program)||||mg/dL||Standard Deviation|Mean
2559623|NCT02674568|Secondary|Number of Participants With Treatment-Related Adverse Events (TEAEs) During Initial Treatment|An adverse event (AE) is defined as any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: is fatal or life-threatening; results in death or hospitalization; is disabling/incapacitating or a congenital anomaly/birth defect; is medically significant. AE severity was graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03 terminology: grade 1=mild; grade 2=moderate; grade 3=severe; grade 4 life-threatening; grade 5=death. TEAEs were defined as AEs that were newly occurring or worsened following study treatment.|From first dose of study drug through the end of the initial treatment period (84 ± 6 days)|Safety analysis population: all participants who received any amount of study drug.|||Participants|||Count of Participants
2559624|NCT02674568|Secondary|Number of Anti-Therapeutic Antibody (ATA) Positive Participants||up to 122.4 weeks; mean (SD) duration of follow-up was 29.0 (23.77) weeks|All participants who received rovalpituzumab tesirine and had at least one sample screened for ATA against rovalpituzumab tesirine antibody-drug conjugate concentration.|||Participants|||Count of Participants
2559625|NCT02674568|Secondary|Rovalpituzumab Tesirine Antibody-Drug Conjugate Plasma Concentrations by Study Visit||Cycle 1: Day 1, 30 minutes pre-infusion; Day 1, 30 minutes post-infusion; Day 3; Day 15; Day 29. Cycle 2: Day 1, 30 minutes pre-infusion; Day 1, 30 minutes post-infusion; Day 3; Day 15; Day 29; End of Treatment (up to Day 29).|Pharmacokinetic Analysis Population: all participants who receive at least 1 dose of study treatment and at least 1 post-baseline blood sample following a dose of study treatment and had an assessment at given time point.|||ng/mL||Standard Deviation|Mean
2559626|NCT02674568|Secondary|Duration of Clinical Benefit|"Duration of clinical benefit is defined as time from the date of first documented CR or PR or SD of ≥ 42 days from first dose date (-7 days to allow for scheduled visit window per the protocol) to the documented date PD or death, whichever occurs first. Analyzed based on response assessments from both the IRC and investigators.~CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|up to 122.4 weeks; mean (SD) duration of follow-up was 29.0 (23.77) weeks|Modified Intent to Treat Population: all participants who received any amount of study drug with best overall response of CR or PR or SD.|||months||95% Confidence Interval|Median
2559627|NCT02674568|Secondary|Clinical Benefit Rate|"Clinical benefit rate is defined as the percentage of participants with an overall response of CR or PR or stable disease (SD) with SD of a minimum duration of 42 days from the first dose date. Analyzed based on response assessments from both the IRC and investigators.~CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.~PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. (The appearance of one or more new lesions is also considered progression.)"|up to 122.4 weeks; mean (SD) duration of follow-up was 29.0 (23.77) weeks|Modified Intent to Treat Population: all participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
2559628|NCT02674568|Secondary|Progression-Free Survival|"Progression-free survival is defined as the time from the first dose date to the documented date of PD or death, whichever occurred first. Participants who neither progressed nor died were censored at the last evaluable disease assessment. Analyzed based on response assessments from both the IRC and investigators. Based on Kaplan-Meier estimates.~PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. (The appearance of one or more new lesions is also considered progression.)"|up to 122.4 weeks; mean (SD) duration of follow-up was 29.0 (23.77) weeks|Modified Intent to Treat Population: all participants who received any amount of study drug.|||months||95% Confidence Interval|Median
2559629|NCT02674568|Secondary|Duration of Objective Response|"Duration of objective response is defined as the time from the date of first documented CR or PR of participants with a confirmed response to the documented date of progressive disease (PD) or death, whichever occurred first. Participants who neither progressed nor died are censored at the last evaluable disease assessment. Analyzed based on response assessments from both the IRC and investigators. Based on Kaplan-Meier estimates.~CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. (The appearance of one or more new lesions is also considered progression.)"|up to 122.4 weeks; mean (SD) duration of follow-up was 29.0 (23.77) weeks|Modified Intent to Treat Population: all participants who received any amount of study drug and had an objective response.|||months||95% Confidence Interval|Median
2559630|NCT02674568|Secondary|Overall Response Rate|"Overall response rate is defined as the percentage of participants with a response of CR or PR, regardless of confirmation, per RECIST v 1.1 prior to receiving any subsequent anticancer therapy and retreatment. Any participants not exhibiting a response (CR or PR) as defined above were considered non-responders. Analyzed based on response assessments from both the IRC and investigators.~CR: disappearance of all target lesions.Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."|up to 122.4 weeks; mean (SD) duration of follow-up was 29.0 (23.77) weeks|Modified Intent to Treat Population: all participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
2559651|NCT02674204|Secondary|Change in Left Ventricular Untwisting Rate as Measured by CMRI||Baseline to 12 months of follow-up|As accrual fell well below target, change in left ventricular untwisting rate as measured by CMRI was not calculated.||||||
2559631|NCT02674568|Primary|Overall Survival|Overall survival is defined as the time from the first dose date to death for any reason. Participants who were alive at the clinical data cut-off were censored at the last known alive date. Based on Kaplan-Meier estimates.|up to 122.4 weeks; mean (SD) duration of follow-up was 29.0 (23.77) weeks|Modified Intent to Treat Population: all participants who received any amount of study drug.|||months||95% Confidence Interval|Median
2559632|NCT02674568|Primary|Objective Response Rate|"Objective response is defined as a participant with the best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, prior to receiving any subsequent anticancer therapy and retreatment, and is confirmed by a consecutive response assessment at least 4 weeks (28 days) from the initial determination of CR/PR. Analyzed based on response assessments from both the Independent Review Committee (IRC) and investigators.~CR: disappearance of all target lesions.Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."|up to 122.4 weeks; mean (SD) duration of follow-up was 29.0 (23.77) weeks|Modified Intent to Treat Population: all participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
2559633|NCT02674477|Secondary|Number of Participants Enrolled in Post-discharge Treatment for Other Mental Health Appointments 30 Days After Hospital Discharge||30 days after discharge from the hospital|We only analyzed those who were referred to other mental health treatment, and for whom we were able to receive the information from their treatment program|||Participants|||Count of Participants
2559634|NCT02674477|Secondary|Number of Participants Enrolled in Post-discharge Substance Abuse Treatment Appointments 30 Days After Hospital Discharge||30 days after discharge from the hospital|We only analyzed those who were referred to substance abuse treatment, and for whom we were able to receive the information from their treatment program|||Participants|||Count of Participants
2559635|NCT02674477|Primary|Acceptability of Treatment Based on Survey Questionnaire Completed by Participants|The acceptability assessment asks about hospital satisfaction for both groups. The questionnaire is a series of questions on Qualtrics on a scale of 0-10. Higher scores signified a more positive response and a better outcome.|prior to discharge from the hospital up to 30 days||||score on a scale||Standard Error|Mean
2559636|NCT02674412|Secondary|Change in Percentage of Normal Swallows Recorded in a Series of 10 Measured Swallows.|A normal swallow is defined as a swallow with a Distal Contractile Index greater than 450mm Hg|14 days||||percentage of swallows||Standard Deviation|Mean
2559637|NCT02674412|Secondary|Change in Gastroesophageal Reflux Disease - Health Related Quality Questionnaire Score|A 16-question questionnaire with a score range from 0 to 80, with higher scores indicating worse outcomes (more severe symptoms of GERD).|Change in the score from Baseline to 14 days||||Scores on a scale||Standard Deviation|Mean
2559638|NCT02674412|Primary|Change in Distal Contractile Index (DCI) on High Resolution Esophageal Manometry|DCI is a measure of the strength of muscle contractions in the esophagus while swallowing. It is measured in mm Hg, and values greater than 450mm Hg are considered Normal.|Change in the score from Baseline to 14 days||||mm Hg||Standard Deviation|Mean
2559639|NCT02674334|Secondary|Change in Mini Mental State Exam (MMSE) > 2 or a Score of 23 up to Two Weeks After Surgery Minus Baseline Value|Change in total score of the MMSE measurement taken at baseline before surgery compared to the follow up measurement taken up to two weeks after surgery. Total range is zero to 30 with higher values indicating a better outcome. Indicator of cognitive decline measured by a change in Mini Mental State Exam (MMSE) > 2 or a score of 23 for two time points; up to two weeks after surgery minus the baseline value.|baseline and up to two weeks|Participants who underwent elective shoulder surgery in the beach chair position at West Virginia University Medicine Hospital.|||scores on a scale|participants|Standard Error|Mean
2559640|NCT02674334|Primary|Percentage of Participants With 20+% Cerebral Desaturation Events|Cerebral desaturation event defined as a 20% or greater decrease from baseline Mean Arterial Pressure, while undergoing elective ambulatory surgery in the beach chair position|one day|Participants undergoing elective shoulder surgery in the beach chair position at West Virginia University Medicine Hospital.|||Participants|||Count of Participants
2559641|NCT02674204|Secondary|Change in Native T2 as Measured by CMRI||Baseline to 12 months of follow-up|As accrual fell well below target, change in native T2 as measured by CMRI was not calculated.||||||
2559642|NCT02674204|Secondary|Change in Extracellular Volume as Measured by CMRI||Baseline to 12 months of follow-up|As accrual fell well below target, change in extracellular volume as measured by CMRI was not calculated.||||||
2559643|NCT02674204|Secondary|Change in Post Contrast T1 as Measured by CMRI||Baseline to 12 months of follow-up|As accrual fell well below target, change in post contrast T1 as measured by CMRI was not calculated.||||||
2559644|NCT02674204|Secondary|Change in Native T1 as Measured by CMRI||Baseline to 12 months of follow-up|As accrual fell well below target, change in native T1 as measured by CMRI was not calculated.||||||
2559645|NCT02674204|Secondary|Change in Left Ventricular Concentricity as Measured by CMRI||Baseline to 12 months of follow-up|As accrual fell well below target, change in left ventricular concentricity as measured by CMRI was not calculated.||||||
2559646|NCT02674204|Secondary|Change in Left Ventricular Mass as Measured by CMRI||Baseline to 12 months of follow-up|As accrual fell well below target, change in left ventricular mass as measured by CMRI was not calculated.||||||
2559647|NCT02674204|Secondary|Change in Cardiac Output as Measured by CMRI||Baseline to 12 months of follow-up|As accrual fell well below target, change in cardiac output as measured by CMRI was not calculated.||||||
2559648|NCT02674204|Secondary|Change in Left Ventricular End Systolic Volume as Measured by CMRI||Baseline to 12 months of follow-up|As accrual fell well below target, change in left ventricular end systolic volume as measured by CMRI was not calculated.||||||
2559649|NCT02674204|Secondary|Change in Left Ventricular End Diastolic Volume as Measured by CMRI||Baseline to 12 months of follow-up|As accrual fell well below target, change in left ventricular end diastolic volume as measured by CMRI was not calculated.||||||
2559650|NCT02674204|Secondary|Change in Left Ventricular Ejection Fraction as Measured by CMRI||Baseline to 12 months of follow-up|As accrual fell well below target, change in left ventricular ejection fraction as measured by CMRI was not calculated.||||||
2559657|NCT02673918|Secondary|Ability to Perform Activities of Daily Living|QuickDASH (Disabilities of the Arm, Shoulder, and Hand) scores 0 to 100 with higher scores indicating more limitations in upper-body functioning.|12 weeks|At baseline, 35 participants in part 1 and 20 participants in part 2 completed the QuickDASH questionnaire. At follow-up, 24 participants in part 1 and 17 participants in part 2 completed the questionnaire.|||score on a scale||Standard Deviation|Mean
2559658|NCT02673918|Secondary|Clinical Outcomes in Upper-body Function: Pain|Patient-reported pain on a 0-10 Visual Analogue Scale in the breast/arm region. A higher score indicates greater level of pain. Changes from baseline will be calculated. This data was only collected for part 1.|12 weeks|Participants in part 2 did not have a clinical assessment at follow up and this data is therefore not collected for part 2, but only collected for part 1.|||score on a scale||Inter-Quartile Range|Median
2559659|NCT02673918|Secondary|Clinical Outcomes in Upper-body Function: Arm Circumference|Arm circumference at 5 points along the arm. Changes from baseline will be calculated.|12 weeks|Handling errors compromised data integrity. Specifically, data was not collected at the end of study time point. This prohibited reporting and analysis of data.||||||
2559660|NCT02673918|Secondary|Clinical Outcomes in Upper-body Function: Muscle Strength|Upper body muscle strength was tested using Manual Muscle Testing among participants in part 1 only.|12 weeks|A 3-level categorical outcome was applied (not limited, moderately limited, greatly limited).|||Participants|||Count of Participants
2559661|NCT02673918|Secondary|Clinical Outcomes in Upper-body Function: Mobility|Active shoulder mobility for flexion and external rotation. Changes from baseline to follow-up (12 weeks later) will be calculated. This data was only collected for participants in part 1.|12 weeks|A 3-level categorical outcome was applied (not limited, moderately limited, greatly limited).|||Participants|||Count of Participants
2559662|NCT02673918|Secondary|Motivation for Rehabilitation Exercises|To answers questions on motivation, the participants' reaction to the intervention, intend to use, and perceived appropriateness of the rehabilitation exercises will be answered. Behavioral changes in motivation to do home-based rehabilitation exercises will be measured as this is fundamental to adherence. The study method is theoretically based in the framework of Theory of Planned Behavior and has been validated in measuring motivation for exercise among cancer survivors including breast cancer patients. The Intention, Attitude and Subjective Norm Questionnaire is a 19-item Theory of Planned Behavior questionnaire modified for use with online home-based rehabilitation. All questions are answered using a 7 point Likert scale and produces effect sizes (Cohen's D). The Theory of Planned Behavior scale is scored on a 0 to 7 scale with a higher score indicating a greater level of motivation.|12 weeks|"In part 1, the subscale Intention had too low internal consistency to be included in the analysis. No results are therefore reported for this group."|||score on a scale||Standard Deviation|Mean
2559663|NCT02673918|Primary|Adherence|Participants in part 1 and part 2 were asked to perform the rehabilitation program at least four times weekly for the duration of the study (12 weeks). Adherence was calculated as the number and proportion of participants who reported in a follow-up questionnaire that they had performed four or more weekly sessions. As such, participants who reported to have completed the home-based rehabilitation program 4 times per week were categorized as having adhered to the program. Likewise, participants who reported to have completed the program 3 times or fewer per week were categorized as not having adhered to the program.|12 weeks|This is the number of participants in part 1 and part 2 who completed the study and who's data was analysed.|||Participants|||Count of Participants
2559664|NCT02673918|Primary|Capacity/ Resources|The amount of time spent with each participant during the standard upper-body assessments, instruction of the home-based intervention and assistance needed with using the website during the study period will be tracked. In addition, any additional appointments required to teach the home-based rehabilitation program or to assist in using the website will be recorded. This information will help to determine the resources needed to administer the online component of the home-based program on a larger scale to a broader group of participants. This data was only collected for Part 1.|12 weeks|The data on capacity was only collected for Part 1 participants and not for part 2.|||minutes||Standard Deviation|Mean
2559665|NCT02673918|Primary|"Number of Participants Reporting Being Very Satisfied or Somewhat Satisfied With the Program"|"At the end of the study data describing participant satisfaction will be collected to answers questions on acceptability. All participants in part 1 and part 2 will be given a questionnaire, delivered by Easy Research, and will be asked to rank various aspects of the intervention such as the home-based exercises supported by videos, mode of delivery, software, etc. as not at all satisfied, not very satisfied, somewhat satisfied or very satisfied. Feasibility will be defined as >75% of participants reporting they are very or somewhat satisfied with the intervention."|12 weeks|This is the number of participants in part 1 and part 2 who completed the study and who's data was analyzed.|||Participants|||Count of Participants
2559666|NCT02673918|Primary|Retention|Participants who are enrolled in the study but fail to complete the end of study assessment will be recorded as dropouts. Feasibility will be defined as a drop out of <10%|12 weeks||||Participants|||Count of Participants
2559667|NCT02673918|Primary|Recruitment Rate|This outcome represent the number and proportion (%) of eligible patients who consented to participate in the study. Recruitment was open for 10 weeks for participants in Part 1 and for 20 weeks for participants in Part 2.|10 weeks for part 1 and 20 weeks for part 2|This was the number of women who were eligible and invited to participate.|||Participants|||Count of Participants
2559668|NCT02673619|Secondary|Number of Participants With Local Tolerability Assessments|Skin tolerability was assessed by a 5-point tolerability scale ranging from 0 to 4; where 0 (no irritation), 1 (mild), 2 (moderate), 3 (severe) to 4 (Very Severe).The participants with data available at specified time points were represented by n=x in the category titles.|Day 1, 8, 15, 22, 27, 28, 29, 30, 36 and 43|Safety Population|||Participants|||Number
2559669|NCT02673619|Secondary|Change From Baseline in Weight|Weight measurement was performed as a measure of safety. Baseline value was the latest assessment prior to first dosing. Change from Baseline value was calculated by post-dose visit value minus Baseline value.|Baseline and Up to Day 29|Safety Population|||Kilograms (Kg)||Standard Deviation|Mean
2560133|NCT02668198|Primary|Positive Recurrent Adenomas Using White Light Near Focus Imaging Confirmed by Histology|The number of recurrent adenomas diagnosed positive with white light imaging near focus confirmed by standard histopathology of biopsy.|approximately 6 to 12 months post endoscopic mucosal resection||||adenomas confirmed positive diagnoses|||Number
2559670|NCT02673619|Secondary|Change From Baseline in Heart Rate|Heart rate was measured in a seated position, after 5 minutes rest. Baseline value was the latest assessment prior to first dosing. Change from Baseline value was calculated by post-dose visit value minus Baseline value. The participants with data available at specified time points were represented by n=x in the category titles.|Baseline, Day 15, 27, 28 and 29|Safety Population|||Beats/minute (min)||Standard Deviation|Mean
2559671|NCT02673619|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital signs including SBP and DBP were measured in a seated position, after 5 minutes rest. Baseline value was the latest assessment prior to first dosing. Change from Baseline value was calculated by post-dose visit value minus Baseline value. The participants with data available at specified time points were represented by n=x in the category titles.|Baseline, Day 15, 27, 28 and 29|Safety Population|||Millimiters of mercury (mmHg)||Standard Deviation|Mean
2559672|NCT02673619|Secondary|Change From Baseline in Body Temperature Assessment as a Safety Measure|Body temperature was measured as a vital sign in seated position, after 5 min rest. Baseline value was the latest assessment prior to first dosing. Change from Baseline value was calculated by post-dose visit value minus Baseline value. The participants with data available at specified time points were represented by n=x in the category titles.|Baseline, Day 15, 27, 28 and 29|Safety Population|||Celsius (C)||Standard Deviation|Mean
2559673|NCT02673619|Secondary|Number of Participants With Abnormal Urine Analysis|Urine sample were taken to analyze glucose and protein levels, blood and ketones body.Urinalysis analytes were measured by dipstick test. Results have been reported in a semi-quantitative manner as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations of the analyte in the urine sample. Abnormal laboratory values have been presented in the table. The participants with data available at specified time points were represented by n=x in the category titles.|Day 1, 15 and 29|Safety Population|||Participants|||Number
2559674|NCT02673619|Secondary|Number of Participants With Abnormal Values of Chemistry Parameters Assessment as a Safety Measure|"Blood samples were collected to analyze the abnormal clinical chemistry parameters by Potential Clinical Importance Criteria. The data was presented for only those parameters for which abnormal values were found (calcium, alanine aminotransferase [ALT]). Participants in the higher dose cohort (UMEC group) had abnormal calcium values and for ALT, the abnormal values were found in lower dose cohort (UMEC group). Hence, data was presented only for these specific cohorts. Participants were counted in the category for their values > ref range high and < ref range low. The measurements taken at Day 1, Day 15 and Day 29 were presented. The participants with data available at specified time points were represented by n=x in the category titles. n=0 in category titles represents that the data was not available for participants in respective category or arm."|Day 1, 15 and 29|Safety Population. This outcome measures the number of participants with abnormal values of clinical chemistry parameters, therefore, only the summary for the cohort/lab parameter with abnormal data at a certain time point was presented.|||Participants|||Number
2559675|NCT02673619|Secondary|Number of Participants With Abnormal Values of Hematological Parameters|Blood samples were collected from participants for evaluation of hematology parameters by Potential Clinical Chemistry Criteria. The data was presented for only those hematology parameters for which abnormal values were found (neutrophils and hemoglobin) . During the analysis, no participant in the higher dose cohort- vehicle group, nor in the lower dose cohort (for both UMEC and vehicle groups) had abnormal hematology values that met the pre-specified criteria for potential clinical importance. Hence, the data for only higher dose cohort was presented. The measurements taken at Day 29 were presented. Participants were counted in the category for their values greater than (>) reference (ref) range high and less than (<) ref range low. The participants with data available at specified time points were represented by n=x in the category titles.|Day 29|Safety Population. This outcome measures the number of participants with abnormal values of hematological parameters, therefore, only the summary for the cohort/lab parameter with abnormal data at a certain time point was presented.|||Participants|||Number
2559676|NCT02673619|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Single measurements of 12-lead ECGs were obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. ECG values were recorded as abnormal not clinically significant (NCS) and abnormal clinically significant (CS). The participants with data available at specified time points were represented by n=x in the category titles.|Day 1, 15 and 29|Safety Population|||Participants|||Number
2559677|NCT02673619|Secondary|Number of Participants With Adverse Event (AE) and Serious Adverse Events (SAE's)|An AE was any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was defined as any untoward medical occurrence that, that results in death, life-threatening, requires hospitalization or prolongation of existing hospitalization, disability/incapacity, any a congenital anomaly/birth defect or other situations at any dose.|Up to Day 43|This analysis was performed on safety population comprised of all participants who received study medication.|||Participants|||Number
2559678|NCT02673619|Secondary|Population Pharmacokinetic Profile After Repeat Dosing of UMEC|Population pharmacokinetic profiling was planned to characterize the population pharmacokinetics of UMEC administered topically to both palms in participants with palmar hyperhidrosis. Due to the fact that the majority of the pharmacokinetic samples were below the limit of quantitation, a population pharmacokinetic analysis could not be performed.|Pre dose on Day 27 and 28; 3, 6, 9, 10, 12, 16, 24 hours post dose on Day 29; 36 and 48 hours post dose on Day 30|PKCNC Population||||||
2559679|NCT02673619|Secondary|Plasma Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau)|Trough (pre-dose at the end of each dosing interval) plasma concentration (Ctau) was analyzed at indicated time-points. Trough concentration samples were used for the assessment/attainment of steady state (ss). Samples were collected at nominal times relative to the proposed time of UMEC dosing. NA represents the data was not available for specific arm or category.|Pre dose on Day 27 and 28; 3, 6, 9, 10, 12, 16, 24 hours post dose on Day 29; 36 and 48 hours post dose on Day 30|PKCNC Population|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2559748|NCT02672553|Secondary|Subjects Who Required a Thoracic Resternotomy Over Time|Number of Subjects who had a surgical opening of their chest after their initial aortic heart valve surgery shown over various time points.|30 days, 3 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point Analysis is based on the AI cohort|||Participants|||Count of Participants
2559680|NCT02673619|Secondary|The Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration [AUC(0-t)] and AUC Over the Dosing Interval Tau, [AUC(0-tau)] After Repeat Dosing of UMEC|Blood samples were collected to measure AUC(0-t) at indicated time-points. AUC(0-t) and AUC(0-tau) was calculated by the linear up and log down trapezoidal method. Samples were collected at nominal times relative to the proposed time of UMEC dosing. The participants with data available at specified time points were represented by n=x in the category titles.|Pre dose on Day 28; 3, 6, 9, 10, 12, 16, 24 hours post dose on Day 29; 36 and 48 hours post dose on Day 30|PKCNC Population|||Log (h*pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2559681|NCT02673619|Secondary|The Apparent Terminal Phase Half-life (t1/2) After Repeat Dosing of UMEC|Blood samples were planned to be collected to measure t1/2. The outcome measure was not analyzed due to lack of data availability.|Day 28|PKCNC Population. The terminal phase half-life could not be derived for any of the participants included in the study because of insufficient data in the elimination phase.||||||
2559682|NCT02673619|Secondary|The Terminal Plasma Elimination Rate Constant (Lambda z)|Blood samples were planned to be collected to measure Lambda Z. The outcome measure was not analyzed due to lack of data availability.|Day 28|PKCNC Population. The terminal plasma elimination rate constant could not be derived for any of the participants included in the study because of insufficient data in the elimination phase.||||||
2559683|NCT02673619|Secondary|Time of the Maximum Measured Plasma Concentration (Tmax) After Repeat Dosing of UMEC|Blood samples were collected to measure Tmax at indicated time-points. Tmax is the time to reach Cmax, determined directly from the concentration-time data. Mean and standard deviation has been presented for Tmax values.|Pre dose on Day 28; 3, 6, 9, 10, 12, 16, 24 hours post dose on Day 29; 36 and 48 hours post dose on Day 30|PKCNC Population|||Hours||Standard Deviation|Mean
2559684|NCT02673619|Secondary|Maximum Plasma Concentration (Cmax)|Blood samples were collected to measure Cmax at Day 28. Cmax is the maximum observed concentration, determined directly from the concentration-time data. The geometric mean and geometric coefficient were presented for all log transformed Cmax values.|Day 28|PKCNC Population|||Log (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2559685|NCT02673619|Secondary|Plasma Concentration After Repeat Dosing of UMEC|Blood samples were collected at indicated time points. Samples were collected at nominal times relative to the proposed time of UMEC dosing. NA represents that the values were not available for specific arm or category. The participants with data available at specified time points were represented by n=x in the category titles.|Pre dose on Day 27 and 28; 3, 6, 9, 10, 12, 16, 24 hours post dose on Day 29; 36 and 48 hours post dose on Day 30|The analysis was performed on pharmacokinetic concentration (PKCNC) Population , comprised of all participants in the Safety set for whom at least one pharmacokinetic sample was obtained and analyzed.|||Picogram/milliliter (pg/mL)||Standard Deviation|Mean
2559686|NCT02673619|Secondary|Percentage of Participants With at Least 2-point Decrease From Baseline to Day 29 in HDSS Score|The HDSS was assessed based on a score 1 to 4. The HDSS is a 4-point scale ranging from 1 (sweating never noticeable and never interferes daily activities), 2 (sweating tolerable but sometimes interferes daily activities), 3 (sweating barely tolerable and frequently interferes daily activities) and 4 (sweating intolerable and always interferes daily activities). Baseline value was the latest assessment prior to first dosing. The summary of percentage of participants from both the cohorts with at least 2-point decrease from Baseline in HDDS scores was presented.|Baseline and Day 29|Full Analysis Population|||Percentage of participants|||Number
2559687|NCT02673619|Secondary|Number of Participants With Shift of Response in HDSS Score at Day 29|The HDSS was assessed based on a score 1 to 4 .The HDSS is a 4-point scale ranging from 1 (sweating never noticeable and never interferes daily activities), 2 (sweating tolerable but sometimes interferes daily activities), 3(sweating barely tolerable and frequently interferes daily activities) and 4 (sweating intolerable and always interferes daily activities s). A shift table describing change in response in participants from 1.85 percent cohort to 1.15 percent cohort has been presented for weekly average HDSS scores.|Baseline and Day 29|Full Analysis Population|||Participants|||Number
2559688|NCT02673619|Secondary|Percentage Change From Baseline/Day1 in Amount of Sweat Produced at Day 29|The amount of sweat produced was assessed by gravimetric measurement . Participants remained at rest for at least 20-30 min before the measurements in order to reduce external interference. Baseline value was the latest assessment prior to first dosing. The latest pre-dose value was considered as Baseline value. Percentage change from Baseline was calculated with post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. The summary of percentage change from Baseline in sweat production was presented for the average of both palms.|Baseline and Day 29|Full Analysis Population|||Percentage change of sweat produced||Standard Deviation|Mean
2559689|NCT02673619|Secondary|Change From Baseline in Amount of Sweat Produced at Day 29|The amount of sweat produced was assessed by gravimetric measurement . Participants remained at rest for at least 20-30 min before the measurements in order to reduce external interference. Baseline value was the latest assessment prior to first dosing. The latest pre-dose value was considered as Baseline value.Change from Baseline value was calculated by post-dose visit value minus Baseline value. The summary of change from Baseline in sweat production has been presented for the average of both palms.|Baseline and Day 29|Full Analysis Population|||Milligrams (mg)||Standard Deviation|Mean
2559690|NCT02673619|Secondary|Percentage of Participants With at Least 50% Reduction From Baseline in Sweat Production at Day 29|Percentage of participants at Day 29 post-treatment with at least a 50 percent reduction from Baseline in sweat production was measured by gravimetric analysis. Participants remained at rest for at least 20-30 min before the measurements in order to reduce external interference. The latest pre-dose value was considered as Baseline value. The summary of percentage of participants from both the cohorts with at least 50 percent reduction from Baseline in sweat production was presented for the average of both palms.|Baseline and Day 29|Full Analysis Population|||Percentage of participants|||Number
2559731|NCT02672553|Secondary|Health Care Utilization|The average amount of time the subjects spent in the intensive care unit, the intermediate care length of stay, and the average total length of hospital stay after their heart valve replacement procedure.|Day of surgical procedure through discharge from the hospital, an average of 1.5 weeks|This outcome is reported for subjects where data is available. Analysis is based on the ITT cohort|||Days||Standard Deviation|Mean
2559691|NCT02673619|Primary|Percentage of Participants With at Least 30 Percent Reduction From Baseline in Sweat Production at Day 29|Percentage of participants at Day 29 post-treatment with at least a 30 percent reduction from Baseline in sweat production measured by gravimetry. Participants remained at rest for at least 20-30 min before the measurements in order to reduce external interference. The latest pre-dose value was considered as Baseline value. The summary of percentage of participants from both the cohorts with at least 30 percent reduction from Baseline in sweat production was presented for the average of both palms.|Baseline and Day 29|Full Analysis Population|||Percentage of participants|||Number
2559692|NCT02673619|Primary|Posterior Probability That the Response Rate is Greater Than 50%|A response rate is defined as percentage of participants who achieved at least 30 percent decrease from Baseline in gravimetric sweat production at Day 29. Baseline was latest assessment prior to first dosing. A response rate of greater than 50 percent was considered to be clinically meaningful (greater than 50 percent of participants achieving at least 30 percent decrease from Baseline in gravimetric sweat production at Day 29). The posterior probability that response rate in sweat production is greater than 50 percent was analyzed. The evaluation was performed using Bayesian analysis, in which latest pre-dose value was used as Baseline.|Baseline and Day 29|This analysis was based on full analysis population comprised of all participants receiving study medication and having at least 1 non-missing change from Baseline efficacy assessment at/before Day 29.This analysis assessed whether response rate in UMEC arm exceeded a threshold that would warrant further development and is not relevant for vehicle.|||Posterior Probability|||Number
2559693|NCT02673541|Secondary|Number of Participants With Adverse Events|5. To compare the safety and tolerability of the AXIOS™ stent vs. multiple double pigtail stents in the management of walled-off pancreatic necrosis as assessed by the collected of adverse events over the course of the study, including but not limited to: bleeding, infections, stent migration, surgery and pain.|Subject followed for an average of one year|details of the adverse events are in the adverse events section|||Participants|||Count of Participants
2559694|NCT02673541|Secondary|Frequency of Stent Migration|4. To compare the frequency of stent migration using the AXIOS™ stent vs. multiple double pigtail stents in the management of walled-off pancreatic necrosis.|Subject followed for an average of one year|data not collected||||||
2559695|NCT02673541|Secondary|Number of Additional Procedures|3. To compare the number of additional procedures (surgical, percutaneous, or nasocystic) required to achieve definitive resolution of walled-off pancreatic necrosis using the AXIOS™ stent vs. multiple double pigtail stents.|Subject followed for an average of one year|data not collected||||||
2559696|NCT02673541|Secondary|Number of Endoscopic Sessions|2. To compare the number of endoscopic sessions required to achieve definitive resolution of walled-off pancreatic fluid necrosis using the AXIOS™ stent vs. multiple double pigtail stents.|Subject followed for an average of one year|Data not collected||||||
2559697|NCT02673541|Secondary|Number of Participants With Definitive Resolution|1. To compare the relative efficacy in terms of definitive resolution of walled off pancreatic necrosis using the AXIOS™ stent vs. multiple double pigtail stents.|Subject followed for an average of one year||||participants|||Number
2559698|NCT02673541|Primary|Cost Differences|To compare the cost differences of the AXIOS™ stent vs. multiple double pigtail stents in the management of walled-off pancreatic necrosis.|Subject followed for an average of one year|data was not collected or analyzed||||||
2559699|NCT02673489|Secondary|Percentage of Subjects Who Achieve HCV RNA < LLOQ, TND Through Follow up Week 24|"HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up.~Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria."|At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment, Follow Up Week 4, Follow Up Week 12, Follow Up Week 24|All treated participants|||Percentage||95% Confidence Interval|Number
2559700|NCT02673489|Secondary|Percentage of Subjects Who Achieve HCV RNA < LLOQ, TD or TND Through Follow up Week 24|HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria. SVR12 is based on Next Value Carried Backwards approach.|At Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, End of Treatment (24 weeks), Follow Up Week 4 (28 weeks), Follow Up Week 12 (36 weeks), Follow Up Week 24 (48 weeks)|All treated participants|||Percentage||95% Confidence Interval|Number
2559701|NCT02673489|Secondary|Percentage of Participants Who Achieve SVR12 in the Presence and Absence of Baseline NS5A (Non-structural Protein 5A) Resistance-associated Polymorphisms|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach.|Week 12 (Follow-up period)|All treated participants|||Percentage of participants||95% Confidence Interval|Number
2559702|NCT02673489|Primary|Percentage of Participants With Sustained Virologic Response (SVR12)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA measurements are excluded after the start of non-study anti-HCV medication on treatment or during follow-up. Modified (mITT) approach is based on treated subjects. The numerator is based on subjects meeting the response criteria and the Next Value Carried Backwards approach.|Week 12|All treated participants|||Percentage of participants||95% Confidence Interval|Number
2559703|NCT02673372|Primary|Reduction of Pain Score at 30 Minutes|The primary outcome will be the comparative reduction of NRS pain scores between the 2 groups at 30 minutes. The NRS Pain scale ranges from 0 to 10 (0 being no pain at all to 10 being very severe pain; 5 is moderate pain)|30 minutes||||score on a scale||Standard Deviation|Mean
2559729|NCT02672553|Secondary|Amount of Aortic Valvular Regurgitation Over Time.|"Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.~Higher numbers on the scale show a worsening outcome."|Discharge, 30 days, 3 month, 1 year|The outcome is reported for subjects where data is available. Analysis is based on the AI cohort|||Participants|||Count of Participants
2559704|NCT02673333|Primary|Objective Response Rate (ORR)|"using RECIST v1.1 A Simon two stage minimax design will be employed to carry out this objective. In the first stage, 21 patients will be enrolled. If at least 3 out of 21 patients respond (partial response - PR or complete response - CR), we will enroll an additional 18 patients for a total of 39 patients. At the end of the study, 8 of 39 patients will need to respond to consider the therapy promising. The study will be complete when all subjects have either completed 24 months of drug therapy, progressed, or discontinued from the study for other reasons.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"|2 years||||Participants|||Count of Participants
2559705|NCT02673203|Secondary|Nutirion Intake: Protein|Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily protein intake (g/day).|3-5 days||||g/day||95% Confidence Interval|Least Squares Mean
2559706|NCT02673203|Secondary|Nutirion Intake: Fat|Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily fat intake (g/day).|3-5 days||||g/day||95% Confidence Interval|Least Squares Mean
2559707|NCT02673203|Secondary|Nutirion Intake: Carbohydrate|Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily carbohydrate intake (g/day).|3-5 days||||g/day||95% Confidence Interval|Least Squares Mean
2559708|NCT02673203|Secondary|Nutirion Intake: Energy|Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily energy intake (kcal/day).|3-5 days||||kcal/day||95% Confidence Interval|Least Squares Mean
2559709|NCT02673203|Secondary|Average Daily Hunger Rating|Average daily hunger was measured using a self-report scale. Hunger is measured on a scale from 1-10. 10 is the most hungry, 1 is the least hungry.|3-5 days||||score on a scale||95% Confidence Interval|Least Squares Mean
2559710|NCT02673203|Secondary|Difference in Glucose Peak and Nadir|The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the difference in glucose peak and nadir (mg/dl).|3-5 days||||mg/dl||95% Confidence Interval|Least Squares Mean
2559711|NCT02673203|Primary|Glucose Nadir|The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose nadir (mg/dl).|3-5 days||||mg/dl||95% Confidence Interval|Least Squares Mean
2559712|NCT02673203|Primary|Glucose Peak|The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose peak (mg/dl).|3-5 days||||mg/dl||95% Confidence Interval|Least Squares Mean
2559713|NCT02673203|Primary|Rate of Changing Glucose Level|The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the rate of changing glucose level (mg/dl/min).|3-5 days||||mg/dl/min||95% Confidence Interval|Least Squares Mean
2559714|NCT02673138|Secondary|Differences in Glucagon Levels Following the Interruption of the Basal Subcutaneous Insulin Infusion||20 hours||||pg/mL||Standard Error|Mean
2559715|NCT02673138|Secondary|Differences in Free Fatty Acid Levels Following Interruption of Basal Subcutaneous Insulin Infusion||20 hours||||mmol/L||Standard Error|Mean
2559716|NCT02673138|Primary|Differences in BHB (Beta-hydroxybutyrate) Levels Following Interruption of Basal||20 hours||||mmol/L||Standard Error|Mean
2559717|NCT02673138|Primary|Differences in Plasma Glucose Levels Following the Interruption of Basal Subcutaneous Infusion of Insulin|The primary outcome measure for this study will be differences in plasma glucose levels following the interruption of basal subcutaneous infusion of insulin under the two study conditions; i.e., control study during treatment with insulin alone vs. experimental study during treatment with insulin plus canagliflozin or other SGLT2 inhibitor.|20 hours||||mg/dL||Standard Error|Mean
2559718|NCT02672852|Secondary|Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 52|ITT Population in Part B for re-randomized participants (ITT_B_R)|||percentage of participants|||Number
2559719|NCT02672852|Secondary|Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 52|ITT Population in Part B for re-randomized participants (ITT_B_R)|||percentage of participants|||Number
2559730|NCT02672553|Secondary|Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.|Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.|Baseline, Discharge, 30 days, 3 Months, 1 Year|The outcome is reported for subjects where data is available. Analysis is based on the AI cohort|||centimeters squared/meters squared||Standard Deviation|Mean
2559747|NCT02672553|Secondary|Subjects Who Received a Permanent Pacemaker Over Time.|Number of Subjects who received a Permanent Pacemaker shown over various time points.|30 days, 3 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort|||Participants|||Count of Participants
2559720|NCT02672852|Secondary|Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 52|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 52|ITT Population in Part B for re-randomized participants (ITT_B_R)|||percentage of participants|||Number
2559721|NCT02672852|Secondary|Percentage of Participants Achieving an sPGA Score of Clear or Almost Clear at Week 104|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 104|ITT Population in Part B for re-randomized participants (ITT_B_R)|||percentage of participants|||Number
2559722|NCT02672852|Secondary|Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16|The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. NRI was used for missing data.|Week 16|ITT Population in Part A1 (ITT_A1)|||percentage of participants|||Number
2559723|NCT02672852|Secondary|Percentage of Participants Achieving an sPGA Score of Clear at Week 16|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 16|ITT Population in Part A1 (ITT_A1)|||percentage of participants|||Number
2559724|NCT02672852|Secondary|Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 16|ITT Population in Part A1 (ITT_A1)|||percentage of participants|||Number
2559725|NCT02672852|Secondary|Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data.|Week 16|ITT Population in Part A1 (ITT_A1)|||percentage of participants|||Number
2559726|NCT02672852|Primary|Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 52|ITT Population in Part B for re-randomized participants (ITT_B_R): All participants who were randomized to Arm 1 at Baseline and re randomized at Week 28.|||percentage of participants|||Number
2559727|NCT02672852|Primary|Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data.|Week 16|ITT Population in Part A1(ITT_A1)|||percentage of participants|||Number
2559728|NCT02672852|Primary|Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data.|Baseline, Week 16|Intent to treat (ITT) Population in Part A1(ITT_A1): all participants who were randomized at Baseline.|||percentage of participants|||Number
2559732|NCT02672553|Secondary|Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time|The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status. Subjects took this questionnaire at Baseline, 30 days, 3 Months,and 1 Year.|Baseline, 30 days, 3 Months, 1 Year|The outcome is reported where data is available. Analysis is based on the ITT cohort|||units on a scale||Standard Deviation|Mean
2559733|NCT02672553|Secondary|Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time|"Subject's Average Score at Baseline and at each follow-up interval until 2 year - SF-12.~The Medical Outcomes Study Short-Form 12 (SF-12) - Physical Component Summary (PCS) and Mental Component Summary (MCS).~The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worse health status."|Baseline, 30 days, 3 Months, 1 Year|The outcome is reported where data is available. Analysis is based on the ITT cohort|||units on a scale||Standard Deviation|Mean
2559734|NCT02672553|Secondary|Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time|The EuroQol-5 Dimension (EQ-5D) is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.|Baseline, 30 days, 3 Months, 1 Year|The outcome is reported where data is available. Analysis is based on the ITT cohort|||units on a scale||Standard Deviation|Mean
2559735|NCT02672553|Secondary|Conversion of Subjects Undergoing Minimally Invasive Surgical Incision to Full Sternotomy for the Randomized to Edwards INTUITY Group During Surgery.|Subjects Randomized to Edwards INTUITY Group's Surgical Aortic Valve undergoing Minimally Invasive Surgical incision being converted to a Full Sternotomy open procedure During Surgery.|Prior to Surgery|Analysis is based on the ITT cohort|||Participants|||Count of Participants
2559736|NCT02672553|Secondary|Subjects With a Cardiac Reoperation for Any Reason Over Time|Number of subjects who experienced a Cardiac reoperation for any reason shown over various time points.|30 days, 3 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort|||Participants|||Count of Participants
2559737|NCT02672553|Secondary|Subjects With a Cardiac Tamponade Over Time|Number of subjects who experienced a Cardiac Tamponade shown over various time points. Cardiac tamponade is when fluid in the pericardium (the sac around the heart) builds up and results in compression (squeezing) of the heart.|30 days, 3 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort|||Participants|||Count of Participants
2559738|NCT02672553|Secondary|Subjects With a Thromboembolism Over Time|Number of subjects who experienced a Thromboembolism shown over various time points. A thromboembolism is an obstruction of a blood vessel by a blood clot that has become dislodged from another site in the circulation.|30 days, 3 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort|||Participants|||Count of Participants
2559739|NCT02672553|Secondary|Subjects With a Myocardial Infarction Over Time|Number of subjects who experienced a Myocardial Infarction shown over various time points. A Myocardial infarction, commonly known as a heart attack, occurs when blood flow decreases or stops to a part of the heart, causing damage to the heart muscle.|30 days, 3 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort|||Participants|||Count of Participants
2559740|NCT02672553|Secondary|Subjects With a Deep Sternal Would Infection Over Time|Number of subjects who experienced a Deep Sternal Wound Infection shown over various time points.|30 days, 3 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort|||Participants|||Count of Participants
2559741|NCT02672553|Secondary|Subjects With Endocarditis Over Time|Number of subjects who experienced Endocarditis shown over various time points. Endocarditis is an infection of the endocardium, which is the inner lining of your heart chambers and heart valves.|30 days, 3 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort|||Participants|||Count of Participants
2559742|NCT02672553|Secondary|Subjects With Renal Failure Over Time|Number of subjects who experienced Renal (kidney) Failure shown over various time points.|30 days, 3 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort|||Participants|||Count of Participants
2559743|NCT02672553|Secondary|Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time|Number of subjects who experienced a Cerebral Vascular Accident or Permanent Stroke shown over various time points.|30 days, 3 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort|||Participants|||Count of Participants
2559744|NCT02672553|Secondary|Subjects Who Experienced Respiratory Failure Over Time|Number of subjects who experienced a Respiratory Failure shown over various time points. Respiratory failure happens when not enough oxygen passes from your lungs to your blood.|30 days, 3 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort|||Participants|||Count of Participants
2559745|NCT02672553|Secondary|Subjects Who Experienced Major Bleeding Over Time.|Number of subjects who experienced Major Bleeding shown over various time points.|30 days, 3 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort|||Participants|||Count of Participants
2559746|NCT02672553|Secondary|Subjects With a Paravalvular Leak > or Equal to 3+ and/or Requiring Intervention Over Time|"Number of subjects who experienced a Paravalvular Leak shown over various time points.~Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.~Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak.~Higher numbers on the scale show a worsening outcome."|30 days, 3 Months, 1 Year, 2 Years.|Cumulative number of subjects with an event by each time point. Analysis is based on the AI cohort|||Participants|||Count of Participants
2559749|NCT02672553|Secondary|Conversion of Edwards INTUITY Surgical Aortic Valve to Control Surgical Aortic Heart Valves During Surgery.|Subjects randomized to the Edwards INTUITY group that were converted to the control group and received commercially available surgical aortic heart valves during surgery.|Prior to Surgery|Analysis is based on the ITT cohort|||Participants|||Count of Participants
2559750|NCT02672553|Secondary|Amount of Paravalvular Leak Over Time.|"Number of subjects who experienced a Paravalvular Leak shown over various time points.~Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.~Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak.~Higher numbers on the scale show a worsening outcome."|Discharge, 30 days, 3 month, 1 year|The outcome is reported for subjects where data is available. Analysis is based on the AI cohort|||Participants|||Count of Participants
2559751|NCT02672553|Secondary|Subject's Effective Orifice Area (EOA) Measurement Over Time.|Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.|Baseline, Discharge, 30 days, 3 Months, 1 Year|The outcome is reported for subjects where data is available. Analysis is based on the AI cohort|||centimeters squared||Standard Deviation|Mean
2559752|NCT02672553|Secondary|Subject's Average Peak Gradients (mmHg) Measurements Over Time.|Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.|Baseline, Discharge, 30 days, 3 Months, 1 Year|The outcome is reported for subjects where data is available. Analysis is based on the AI cohort|||mmHg||Standard Deviation|Mean
2559753|NCT02672553|Secondary|Subject's Average Mean Gradients (mmHg) Measurements Over Time.|Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.|Baseline, Discharge, 30 days, 3 Months, 1 Year|The outcome is reported for subjects where data is available. Analysis is based on the AI cohort|||mmHg||Standard Deviation|Mean
2559754|NCT02672553|Secondary|Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. Patients with cardiac disease but without resulting limitation of physical activity.~Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.~Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.~Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest."|Baseline and 2 Years.|The outcome is reported for subjects where data is available. Analysis is based on the ITT cohort|||Participants|||Count of Participants
2559755|NCT02672553|Primary|Median Amount of Time Subject Spent on Cardiopulmonary Bypass|Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.|At time of surgery; an average of 1 hour|The outcome is reported for subjects where data is available. Analysis is based on the AI cohort|||Minutes||Full Range|Median
2559756|NCT02672553|Primary|Median Subject Time Spent on Cardiopulmonary Cross Clamp|Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.|At time of surgery; an average of 1 hour|The outcome is reported for subjects where data is available. Analysis is based on the AI cohort|||Minutes||Full Range|Median
2559757|NCT02672514|Primary|Acute Kidney Injury||within the first 30 days (plus or minus 3 days) after surgery||||participants|||Number
2559758|NCT02672423|Primary|PK: Maximum Observed Drug Concentration (Cmax)|Maximum observed drug concentration.|Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||Nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2559759|NCT02672423|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])|Area under the concentration versus time curve from zero to infinity.|Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||Nanograms*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2559760|NCT02672176|Other Pre-specified|PROMIS Physical Function|PROMIS Physical Function (www.healthmeasures.net) The Patient Reported Outcomes Measurement Information System Measures (PROMIS) Physical Function instrument assess the current physical function in the individual. It is a four-item scale measuring self-reported capability of physical activities, using a five item Likert scale (1= not at all, 5 = very much), yielding possible raw scores of 4 to 20. The raw scores are translated to T-scores using a score conversion table, with a possible range of 22.5 to 57.0. A score of 50 equals the mean. Higher scores are associated with higher capability. This instrument has demonstrated validity and reliability with an alpha of 0.91 when evaluated in 4880 patients in a diverse cohort of cancer patients in the US.|9 months||||T-score||Standard Deviation|Mean
2559761|NCT02672176|Other Pre-specified|PROMIS Physical Function|PROMIS Physical Function (www.healthmeasures.net) The Patient Reported Outcomes Measurement Information System Measures (PROMIS) Physical Function instrument assess the current physical function in the individual. It is a four-item scale measuring self-reported capability of physical activities, using a five item Likert scale (1= not at all, 5 = very much), yielding possible raw scores of 4 to 20. The raw scores are translated to T-scores using a score conversion table, with a possible range of 22.5 to 57.0. A score of 50 equals the mean. Higher scores are associated with higher capability. This instrument has demonstrated validity and reliability with an alpha of 0.91 when evaluated in 4880 patients in a diverse cohort of cancer patients in the US.|3 months||||T-score||Standard Deviation|Mean
2561392|NCT02650921|Secondary|Question 1 From Subject Satisfaction Questionnaire|Question 1: I am happier with the overall appearance of my treated hand compared to my untreated hand|Week 12|ITT|||Participants|||Count of Participants
2559762|NCT02672176|Other Pre-specified|PROMIS Physical Function|PROMIS Physical Function (www.healthmeasures.net) The Patient Reported Outcomes Measurement Information System Measures (PROMIS) Physical Function instrument assess the current physical function in the individual. It is a four-item scale measuring self-reported capability of physical activities, using a five item Likert scale (1= not at all, 5 = very much), yielding possible raw scores of 4 to 20. The raw scores are translated to T-scores using a score conversion table, with a possible range of 22.5 to 57.0. A score of 50 equals the mean. Higher scores are associated with higher capability. This instrument has demonstrated validity and reliability with an alpha of 0.91 when evaluated in 4880 patients in a diverse cohort of cancer patients in the US.|Baseline||||T-score||Standard Deviation|Mean
2559763|NCT02672176|Other Pre-specified|PROMIS Emotional Distress Anxiety|PROMIS Emotional Distress Anxiety (www.healthmeasures.net) The Patient Reported Outcomes Measurement Information System Measures (PROMIS) Emotional Distress Anxiety instrument measures self-reported fear, anxious misery and hyperarousal symptoms. Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. The four-item instrument assesses anxiety over the past seven days using a five item Likert scale (1= not at all, 5 = very much), yielding possible raw scores of 4 to 20. The raw scores are translated to T-scores using a score conversion table, with a possible range of 40.3 to 81.6. A score of 50 equals the mean. Higher scores indicate greater emotional distress anxiety. This instrument has demonstrated validity and reliability with an alpha of 0.92 when evaluated in 961 in patients with chronic hepatitis C.|9 months||||T-score||Standard Deviation|Mean
2559764|NCT02672176|Other Pre-specified|PROMIS Emotional Distress Anxiety|PROMIS Emotional Distress Anxiety (www.healthmeasures.net) The Patient Reported Outcomes Measurement Information System Measures (PROMIS) Emotional Distress Anxiety instrument measures self-reported fear, anxious misery and hyperarousal symptoms. Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. The four-item instrument assesses anxiety over the past seven days using a five item Likert scale (1= not at all, 5 = very much), yielding possible raw scores of 4 to 20. The raw scores are translated to T-scores using a score conversion table, with a possible range of 40.3 to 81.6. A score of 50 equals the mean. Higher scores indicate greater emotional distress anxiety. This instrument has demonstrated validity and reliability with an alpha of 0.92 when evaluated in 961 in patients with chronic hepatitis C.|3 months||||T-score||Standard Deviation|Mean
2559765|NCT02672176|Other Pre-specified|PROMIS Emotional Distress Anxiety|PROMIS Emotional Distress Anxiety (www.healthmeasures.net) The Patient Reported Outcomes Measurement Information System Measures (PROMIS) Emotional Distress Anxiety instrument measures self-reported fear, anxious misery and hyperarousal symptoms. Anxiety is best differentiated by symptoms that reflect autonomic arousal and experience of threat. The four-item instrument assesses anxiety over the past seven days using a five item Likert scale (1= not at all, 5 = very much), yielding possible raw scores of 4 to 20. The raw score is translated to a T-score using a score conversion table, with a possible range of 40.3 to 81.6. A score of 50 equals the mean. Higher scores indicate greater emotional distress anxiety. This instrument has demonstrated validity and reliability with an alpha of 0.92 when evaluated in 961 in patients with chronic hepatitis C.|Baseline||||T-score||Standard Deviation|Mean
2559766|NCT02672176|Secondary|Perceived Stress Measured by PSS|Perceived Stress Score (PSS): This is a 4-item instrument administered to patients to measure the degree to which situations in one's life are determined as stressful. The sum total of the responses can range from 0 to 16, with higher scores indicating greater stress. This instrument has acceptable reliability with an alpha of 0.60. This scale has been used and validated in a number of chronic diseases including diabetes.|9 months||||units on a scale||Standard Deviation|Mean
2559767|NCT02672176|Secondary|Perceived Stress Measured by PSS|Perceived Stress Score (PSS): This is a 4-item instrument administered to patients to measure the degree to which situations in one's life are determined as stressful. The sum total of the responses can range from 0 to 16, with higher scores indicating greater stress. This instrument has acceptable reliability with an alpha of 0.60. This scale has been used and validated in a number of chronic diseases including diabetes.|3 months||||units on a scale||Standard Deviation|Mean
2559768|NCT02672176|Secondary|Perceived Stress Measured by PSS|Perceived Stress Score (PSS): This is a 4-item instrument administered to patients to measure the degree to which situations in one's life are determined as stressful. The sum total of the responses can range from 0 to 16, with higher scores indicating greater stress. This instrument has acceptable reliability with an alpha of 0.60. This scale has been used and validated in a number of chronic diseases including diabetes.|Baseline||||units on a scale||Standard Deviation|Mean
2559769|NCT02672176|Secondary|Depression Severity Measured by PHQ-9|Depressive symptoms were measured with the PHQ-9. This is a 9-question instrument commonly administered to patients in a primary care setting to screen for the presence and severity of depression. The sum total of the responses ranges from 0 to 27. The total score determines the level of depressive symptoms. Higher scores indicate more depressive symptoms. In general, a score of 10 or above is suggestive of the presence of depression. This instrument has demonstrated validity and reliability with an alpha of 0.89 when evaluated in 3000 primary care patients.|9-months||||units on a scale||Standard Deviation|Mean
2559770|NCT02672176|Secondary|Depression Severity Measured by PHQ-9|Depressive symptoms were measured with the PHQ-9. This is a 9-question instrument commonly administered to patients in a primary care setting to screen for the presence and severity of depression. The sum total of the responses ranges from 0 to 27. The total score determines the level of depressive symptoms. Higher scores indicate more depressive symptoms. In general, a score of 10 or above is suggestive of the presence of depression. This instrument has demonstrated validity and reliability with an alpha of 0.89 when evaluated in 3000 primary care patients.|3 months||||units on a scale||Standard Deviation|Mean
2559771|NCT02672176|Secondary|Depression Severity Measured by PHQ-9|Depressive symptoms were measured with the PHQ-9. This is a 9-question instrument commonly administered to patients in a primary care setting to screen for the presence and severity of depression. The sum total of the responses ranges from 0 to 27. The total score determines the level of depressive symptoms. Higher scores indicate more depressive symptoms. In general, a score of 10 or above is suggestive of the presence of depression. This instrument has demonstrated validity and reliability with an alpha of 0.89 when evaluated in 3000 primary care patients.|Baseline||||units on a scale||Standard Deviation|Mean
2561393|NCT02650921|Secondary|Evaluate GAIS by Subject|Global Aesthetic Improvement Scale|24 weeks|ITT|||Participants|||Count of Participants
2559772|NCT02672176|Primary|Diabetes Self-Efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)- Scores at 9-months|Diabetes self-efficacy (Diabetes Empowerment Scale (DES)-Short Form) (http://diabetesresearch.med.umich.edu/Tools_SurveyInstruments.php). This eight-item survey instrument is derived from the 37 item DES survey, measuring diabetes-related psychosocial self-efficacy. The scale uses a 5-point Likert scale with raw scores on the scale ranging from 8 to 40. Total score is calculated as the sum of the eight questions divided by the number of items in the survey (range is 1 to 8), with higher scores indicating greater self-efficacy. The tool is a valid and reliable measure of overall diabetes-related psychosocial self-efficacy with an alpha of 0.84. Concurrent validity was established with attitudes about having diabetes, understanding diabetes and improved A1C scores. A 0.25 point difference in this score is equivalent to a shift of at least one point in two questions in the DES tool; in other words, they have improved their confidence in engaging in self-management behavior in two areas.|9-months||||units on a scale||Standard Deviation|Mean
2559773|NCT02672176|Primary|Diabetes Self-Efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)|Diabetes self-efficacy (Diabetes Empowerment Scale (DES)-Short Form) (http://diabetesresearch.med.umich.edu/Tools_SurveyInstruments.php). This eight-item survey instrument is derived from the 37 item DES survey, measuring diabetes-related psychosocial self-efficacy. The scale uses a 5-point Likert scale with raw scores on the scale ranging from 8 to 40. Total score is calculated as the sum of the eight questions divided by the number of items in the survey (range is 1 to 8), with higher scores indicating greater self-efficacy. The tool is a valid and reliable measure of overall diabetes-related psychosocial self-efficacy with an alpha of 0.84. Concurrent validity was established with attitudes about having diabetes, understanding diabetes and improved A1C scores. A 0.25 point difference in this score is equivalent to a shift of at least one point in two questions in the DES tool; in other words, they have improved their confidence in engaging in self-management behavior in two areas|3 months||||units on a scale||Standard Deviation|Mean
2559774|NCT02672176|Primary|Diabetes Self-efficacy Measured Using the Diabetes Empowerment Scale Short Form (DES-SF)- Scores at Baseline|Diabetes self-efficacy (Diabetes Empowerment Scale (DES)-Short Form) (http://diabetesresearch.med.umich.edu/Tools_SurveyInstruments.php). This eight-item survey instrument is derived from the 37 item DES survey, measuring diabetes-related psychosocial self-efficacy. The scale uses a 5-point Likert scale with raw scores on the scale ranging from 8 to 40. Total score is calculated as the sum of the eight questions divided by the number of items in the survey (range is 1 to 8), with higher scores indicating greater self-efficacy. The tool is a valid and reliable measure of overall diabetes-related psychosocial self-efficacy with an alpha of 0.84. Concurrent validity was established with attitudes about having diabetes, understanding diabetes and improved A1C scores. A 0.25 point difference in this score is equivalent to a shift of at least one point in two questions in the DES tool; in other words, they have improved their confidence in engaging in self-management behavior in two areas|Baseline|Diabetes self-efficacy at baseline|||Units on a scale||Standard Deviation|Mean
2559775|NCT02672111|Secondary|Summary of Need to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population)|"The following results summarize the need to use VAS over a period of 12 months - 48 weeks. Need to Use assessments were administered using a unipolar 100 mm VAS. Subjects were asked Since your last scheduled assessment visit, indicate your worst or strongest need to use opioids, where 0 = No need to use and 100 mm = Strongest possible need."|12 months- 48 week|Efficacy Population|||score on a scale||Standard Deviation|Mean
2559776|NCT02672111|Secondary|Summary of Desire to Use Visual Analog Scale (VAS) at Selected Time Points (Efficacy Population)|"The following table summarizes the desire to use measurements over a period of 12 months - 48 weeks. Desire to Use assessments were administered using a unipolar 100 mm VAS. Subjects were asked Since your last scheduled assessment visit, indicate your worst or strongest desire to use opioids, where 0 = No desire to use and 100 mm = Strongest possible desire."|12 months- 48 week|Efficacy Population|||score on a scale||Standard Deviation|Mean
2559777|NCT02672111|Secondary|Summary of Subjective Opiate Withdrawal Scale (SOWS) at Selected Time Points (Efficacy Population)|"Summary of SOWS over time to show withdrawal symtons, from baseline to end of treatment. This form contains 16 questions that rate the intensity of withdrawal from 0 (Not at all) to 4 (Extremely), with higher scores associated with greater withdrawal symptoms and total range for all items of 0-64"|12 months- 48 week|Efficacy Population|||score on a scale||Standard Deviation|Mean
2559778|NCT02672111|Secondary|Summary of Clinical Opiate Withdrawal Scale (COWS) at Selected Time Points (Efficacy Population)|A summary of COWS (administered by the Clinician) over 48 weeks to show withdrawal symptoms from baseline to end of treatment. This scale consists of 11 common opiate withdrawal signs or symptoms, rated on a numeric scale from 0 to 4 or 5 and based on a timed period of observation of the subject by the rater. Higher scores are associated with greater withdrawal symptoms with a total range for all items of between 0-48|12 months- 48 week|Efficacy Population|||score on a scale||Standard Deviation|Mean
2559779|NCT02672111|Secondary|Summary of Retention in Treatment (Efficacy Population)|The following is a summary of treatment retention over 48 weeks|48 weeks of treatment|Efficacy Population|||weeks||Standard Deviation|Mean
2559780|NCT02672111|Secondary|Mean Percentage of Self-reported No Illicit Opioid Use (Efficacy Population)|The following is a summary of Mean Percentage of Self-Reported No Illicit Opioid Use (Efficacy Population)|12 months (48 weeks)|Efficacy Population|||percentage of no illicit opioid use||Standard Deviation|Mean
2559781|NCT02672111|Secondary|Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population)|The following is a summary of Mean Percentage of Negative Urine Toxicology Results for Illicit Opioid Use Supported by Self Reported Illicit Opioid Use (Efficacy Population)|12 months (48 weeks)|Efficacy Population|||percentage of negative urine samples||Standard Deviation|Mean
2559782|NCT02672111|Primary|Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Full Exposure Safety Population|Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Full Exposure Safety Population|12 months- 48 week|Full Exposure Safety Population-Subjects treated with CAM2038|||participants|||Number
2560134|NCT02668198|Primary|Positive Recurrent Adenomas Using White Light Near Focus Imaging|The number of positive diagnoses using white light near focus optical imaging only.|approximately 6 to 12 months post endoscopic mucosal resection||||adenomas with positive diagnoses|||Number
2559783|NCT02672111|Primary|Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population|Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Overall Safety Population|12 months- 48 week|Overall Safety Population-Subjects treated with CAM2038|||participants|||Number
2559784|NCT02672033|Secondary|Pathologic Complete Response Rate (pCR)|No data displayed because Outcome Measure has zero total participants analyzed.|Up to 5 years post-treatment|Data was not collected||||||
2559785|NCT02672033|Secondary|Overall Survival (OS)|No data displayed because Outcome Measure has zero total participants analyzed.|Up to 5 years post-treatment|Data was not collected||||||
2559786|NCT02672033|Secondary|Local Control (LC)|Cumulative incidence approach will be used to estimate the local failure rates. No data displayed because Outcome Measure has zero total participants analyzed.|Up to 5 years post-treatment|No data was collected||||||
2559787|NCT02672033|Secondary|Disease Specific Survival (DSS)|Cumulative incidence approach will be used to estimate DSS. No data displayed because Outcome Measure has zero total participants analyzed.|Up to 5 years post-treatment|No data was collected||||||
2559788|NCT02672033|Primary|Incidence of Chronic Toxicity as Assessed by the NCI CTCAE Version 4.0|No data displayed because Outcome Measure has zero total participants analyzed.|Up to 5 years post-treatment|Data was not collected||||||
2559789|NCT02672033|Primary|Incidence of Acute and Subacute Toxicity Defined as Grade 4 or 5 Adverse Events as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|No data displayed because Outcome Measure has zero total participants analyzed.|Up to 3 months|Data was not collected||||||
2559790|NCT02672033|Primary|Ability to Accrue Sufficient Patients to Draw Conclusions About Endpoints in a Timely and Expedient Manner|No data displayed because Outcome Measure has zero total participants analyzed.|Up to 1 year|Data was not collected||||||
2559791|NCT02671760|Secondary|Safety and Tolerability in Terms of Residual Sleepiness|Digit Symbol Substitution Test. The test score is number of correct answers in 90 seconds. Higher scores indicate favorable response (i.e., less residual sleepiness). The duration of the challenge is the 90 second time limit; there is no theoretical maximum score to attain.|8 hours||||Correct answers||Standard Deviation|Mean
2559792|NCT02671760|Secondary|Safety and Tolerability in Terms of Residual Sleepiness|Karolinska Sleepiness Scale. This is a 9-point scale with values ranging from 1 (extremely alert) to 9 (extremely sleepy). Lower scores indicate less residual sleepiness.|8 hours||||Units on a scale||Standard Deviation|Mean
2559793|NCT02671760|Secondary|Adverse Events|Safety and tolerability assessed in terms of the incidence of AEs|8 hours||||Number of Events|||Number
2559794|NCT02671760|Secondary|Latency to REM Sleep Onset|Time required to achieve REM sleep|8 hours||||minutes||Standard Deviation|Mean
2559795|NCT02671760|Secondary|Awakenings||8 hours||||Awakenings||Standard Deviation|Mean
2559796|NCT02671760|Secondary|Latency to Persistent Sleep|Time it takes to fall asleep|8 hours||||minutes||Standard Deviation|Mean
2559797|NCT02671760|Primary|Total Sleep Time||8 hours||||minutes||Standard Deviation|Mean
2559798|NCT02671500|Secondary|Percentage of Participants With Overall Virologic Failure|Virologic failure was defined as: (1) On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) or (2) Virologic relapse: confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2559799|NCT02671500|Secondary|Change From Baseline in HCV RNA||Baseline and up to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2559800|NCT02671500|Secondary|Percentage of Participants With HCV RNA < LLOQ On Treatment||Weeks 1, 2, 4, 6, 8, 10, and 12|Participants in the Full Analysis Set with available data were analyzed.|||Percentage of participants||95% Confidence Interval|Number
2559801|NCT02671500|Secondary|Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)|SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2559802|NCT02671500|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||Percentage of participants||95% Confidence Interval|Number
2559803|NCT02671500|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||Percentage of participants|||Number
2559804|NCT02671500|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set included participants who were enrolled into the study and received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2559805|NCT02671461|Secondary|Percentage of Participants Composite of Adjudicated Recurrent Ischemic Stroke, Myocardial Infarction, or Cardiovascular Death|The percentage of treated participants with composite of adjudicated recurrent ischemic stroke, myocardial infarction, or cardiovascular death was reported by arm.|Day 90|Insufficient data available to perform analysis due to study termination||||||
2559806|NCT02671461|Secondary|Percentage of Participants With Composite of Unrecognized Brain Infarction Assessed by MRI at Day 28 and MACE at Day 90|The percentage of participants with unrecognized brain infarction at Day 28 and MACE at Day 90 was to be reported by arm for all treated participants.|Day 90|Insufficient data available to perform analysis due to study termination||||||
2559807|NCT02671461|Secondary|Percentage of Participants With Adjudicated Symptomatic Recurrent Stroke (Including Fatal and Non-fatal)|The percentage of participants with adjudicated symptomatic recurrent stroke at Day 28 was to be reported by arm for all treated participants.|Day 28|Insufficient data available to perform analysis due to study termination||||||
2561394|NCT02650921|Secondary|Evaluate GAIS by Subjects|Global Aesthetic Improvement Scale|20 weeks|ITT|||Participants|||Count of Participants
2559808|NCT02671461|Secondary|Percentage of Participants With Major Adverse Cardiovascular Events (MACE)|MACE was defined as a composite of adjudicated recurrent stroke, myocardial infarction, or cardiovascular death. The percentage of treated participants experiencing these events at Day 90 was to be reported by arm.|90 days|Insufficient data available to perform analysis due to study termination||||||
2559809|NCT02671461|Primary|Percentage of Participants With Composite of Adjudicated Major Bleeding and Adjudicated Clinically Relevant Non-major (CRNM) Bleeding During the Treatment Period|The percentage of participants with composite of major bleeding and CRNM bleeding was to be reported. Point estimates and 95% CIs for event rates were to be presented by treatment, together with point estimates and 95% CIs for the difference of event rates between each BMS-986141 arm and placebo.|Up to 90 days|Insufficient data available to perform analysis due to study termination||||||
2559810|NCT02671461|Primary|Number of Participants With Composite of Symptomatic Ischemic Stroke by Day 28 and Unrecognized Brain Infarction Assessed by MRI at Day 28|The incidence of a composite of symptomatic ischemic stroke by Day 28 and unrecognized brain infarction assessed by MRI at Day 28 was to be reported by arm in all treated participants.|28 Days|Insufficient data available to perform analysis due to study termination||||||
2559811|NCT02671266|Secondary|Amount of Initial Monetary Transfer During Trust Game|Participants will have the decision of sending between 0 to 10 game dollars to another participant, without any expectation of monetary return. This initial investment amount will serve as a measure of trust, with a transfer of 0 game dollars indicating no trust and a transfer of 10 game dollars indicating maximum trust.|At least 45 minutes post nasal spray administration|Sample includes BDD and healthy control participants who completed at least one drug visit. OCD group was excluded from analysis due to difficulties with recruitment.|||units on a scale||Standard Deviation|Mean
2559812|NCT02671266|Secondary|Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task|The outcome measures are response latencies (in milliseconds) on engagement and disengagement trials for disgust, happy, and neutral cue types. Longer response latencies reflect more sustained attention.|At least 45 minutes post nasal spray administration|Data reported for BDD and HC participants who completed at least one drug visit. One HC patient in the oxytocin first arm did not complete second placebo visit. Another HC patient in the placebo first arm had missing data from the placebo visit due to administrative error. OCD group was excluded from analyses due to difficulties with recruitment.|||milliseconds||Standard Deviation|Mean
2559813|NCT02671266|Secondary|Interpretation Questionnaire|This questionnaire includes 33 ambiguous scenarios, representing 3 conditions: BDD threat scenarios, social anxiety threat scenarios, and general threat scenarios. Each item involves 3 possible thoughts that may come to mind in the scenarios which reflect positive, negative, and neutral interpretations. Participants will be asked to rate the likelihood of having each of the thoughts on a scale of 0 (very unlikely) to 4 (very likely). Total scores are reported for negative threat interpretations for each of the 3 conditions (BDD threat, social anxiety threat, general threat), with scores ranging from 0 (very unlikely) to 44 (very likely).|At least 45 minutes post nasal spray administration|One participant (who received oxytocin first) misunderstood the IQ so was excluded from analysis. One subject who received oxytocin first missed the second placebo drug visit. Another subject who received placebo first accidentally did not receive the Interpretation Questionnaire due to administration error. OCD group was excluded from analysis.|||score on a scale||Standard Deviation|Mean
2559814|NCT02671266|Primary|Emotion Recognition Questionnaire|This questionnaire includes 48 items for 2 conditions- a self-referent and other-referent condition. Scores are reported for each condition (self-referent or other-referent) reflecting the number of correct responses. Scores range from 0 (least accurate) to 24 (most accurate) for each condition of the questionnaire.|45 minutes post nasal spray administration|Data reported for BDD and healthy control participants who completed at least one drug visit. There was one patient in the oxytocin first arm who did not complete second placebo drug visit. OCD group was excluded from analyses due to difficulties with recruitment.|||score on a scale||Standard Deviation|Mean
2559815|NCT02671136|Primary|Counts of Each Subgingival Bacterial Species|Subgingival microbial samples will be obtained at baseline and end of the study. Subgingival microbial samples will be collected from three randomly selected sites with probing depth =>5mm. Collected microbial samples will be processed for HOMINGS analysis (The Human Oral Microbe Identification Microarray). Counts and proportions of each bacterial species will be determined for each subject and then averaged across subjects in the two groups. Differences in bacterial profiles will be analyzed using the repeated measures ANCOVA (Analysis of Covariance) procedure for paired observations.|12 weeks|No analysis conducted due to not enough subjects recruited and study terminated early.||||||
2559816|NCT02670928|Secondary|Percentage Hange From Baseline in Body Mass Index (BMI) at Month 12|Changes of Baseline in Body Mass Index (BMI) levels expressed in percents compared to Baseline at 12 months of follow-up|Month 12|Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.|||Percent change||Standard Deviation|Mean
2559817|NCT02670928|Secondary|Percentage Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12|Analysis of percentage changes in Fasting Plasma Glucose (FPG, mmol/l) levels compared to Baseline at 12 months of follow-up|Basline, Month 12|Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.|||Percent change||Standard Error|Mean
2559818|NCT02670928|Secondary|Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 12|Analysis of percentage changes in Glycosylated hemoglobin (HbA1c, %) levels compared to Baseline at 12 months follow-up|Baseline, Month 12|Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.|||Percent change||Standard Deviation|Mean
2559819|NCT02670928|Secondary|Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12|Patients were asked 'When did blood sugar level decrease most recently?' and the responses were reported on a Change in Quality of Life (QoL) expressed in percents using the Novartis survey in hypoglycemia and scale of individual perception of PhA (Scale of Borg)|Baseline, Month 12|Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.|||Percentage of participants|||Number
2561395|NCT02650921|Secondary|Evaluate GAIS by Subjects|Global Aesthetic Improvement Scale|16 weeks|ITT|||Participants|||Count of Participants
2559820|NCT02670928|Secondary|Percentage Change From Baseline in Lipid Protein of High and Low Density at Month 12|Analysis of percentage in lipid profile (LDL, mmol/l and HDL, mmol/l) compared to Baseline at 12 months of follow-up|Baseline, Month 12|Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.|||Percent change||Standard Error|Mean
2559821|NCT02670928|Secondary|Percentage Change From Baseline in Triglycerides at Month 12|Analysis of percentage in lipid profile (triglycerides, mmol/l) compared to Baseline at 12 months of follow-up|Baseline, Month 12|Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.|||Percent change||Standard Error|Mean
2559822|NCT02670928|Secondary|Percentage Change From Baseline in Cholesterol at Month 12|Analysis of percentage changes in lipid profile (cholesterol, mmol/l) compared to Baseline at 12 months of follow-up|Baseline, Month 12|Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.|||Percent change||Standard Error|Mean
2559823|NCT02670928|Secondary|Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline|Number (portion) of patients achieved weight loss by at least 5% in comparison with Baseline at 3, 6, 9 months of follow-up|Baseline, Month 3, Month 6, Month 9, Month 12|Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.|||Percentage of Participants|||Number
2559824|NCT02670928|Secondary|Percentage of Patients Who Achieved a Decrease in Blood Pressure Values From Baseline at Month 12|Decrease in blood pressure value was defined as at least 5 millimeters mercury (mmHg) in systolic and diastolic values in comparison to Baseline|Baseline, Month 12|Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.|||Percentage of Participants|||Number
2559825|NCT02670928|Primary|Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at Month 12|Number (portion) of patients in the active group and control group in whom the body weight decreased by at least 5% compared to Baseline values at 12 months of follow-up|Baseline, Month 12|Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.|||Participants|||Number
2559826|NCT02670915|Secondary|Change in Anti-insulin Aspart Antibody Development: Total|Change from baseline (week 0) in 'total anti-insulin aspart antibodies (specific for insulin aspart and those cross-reacting with human insulin)' was evaluated after 26 weeks of randomisation. This endpoint was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). The results are based on the last on-treatment value.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Number of participants analysed = number of participants contributed to the analysis.|||Percentage of B/T||Standard Deviation|Mean
2559827|NCT02670915|Secondary|Change in Anti-insulin Aspart Antibody Development: Cross-reacting With Human Insulin|Change from baseline (week 0) in 'antibodies for insulin aspart, those cross-reacting with human insulin' was evaluated after 26 weeks of randomisation. This endpoint was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). The results are based on the last on-treatment value.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Number of participants analysed = number of participants contributed to the analysis.|||Percentage of B/T||Standard Deviation|Mean
2559828|NCT02670915|Secondary|Change in Anti-insulin Aspart Antibody Development: Specific|Change from baseline (week 0) in 'antibodies specific for insulin aspart' was evaluated after 26 weeks of randomisation. This endpoint was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). The results are based on the last on-treatment value.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Number of participants analysed = number of participants contributed to the analysis.|||Percentage of B/T||Standard Deviation|Mean
2559829|NCT02670915|Secondary|Change in Lipid Profile: Low Density Lipoproteins (LDL)|Change from baseline (week 0) in LDL after 26 weeks of randomisation is presented as ratio to baseline values. The results are based on the last on-treatment value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2559830|NCT02670915|Secondary|Change in Lipid Profile: High Density Lipoproteins (HDL)|Change from baseline (week 0) in HDL after 26 weeks of randomisation is presented as ratio to baseline values. The results are based on the last on-treatment value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2559831|NCT02670915|Secondary|Change in Lipid Profile: Total Cholesterol|Change from baseline (week 0) in total cholesterol after 26 weeks of randomisation is presented as ratio to baseline values. The results are based on the last on-treatment value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2559832|NCT02670915|Secondary|Change in Biochemistry: Total Bilirubin|Change from baseline (week 0) in total bilirubin was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||umol/L||Standard Deviation|Mean
2559985|NCT02669784|Primary|Ascending Sinotubular Junction Measurement|Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. Measurement was taken at the ascending aorta near the sinotubular junction.|At 30 days|Ascending Sinotubular Junction Measurement was assessed for the following scans: Chest, Abdomen & Pelvis, and Chest, Abdomen, & Pelvis|||Hounsfield units||Full Range|Mean
2559833|NCT02670915|Secondary|Change in Biochemistry: Albumin|Change from baseline (week 0) in albumin was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||g/dL||Standard Deviation|Mean
2559834|NCT02670915|Secondary|Change in Biochemistry: Potassium|Change from baseline (week 0) in potassium was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||mmol/L||Standard Deviation|Mean
2559835|NCT02670915|Secondary|Change in Biochemistry: Sodium|Change from baseline (week 0) in sodium was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||mmol/L||Standard Deviation|Mean
2559836|NCT02670915|Secondary|Change in Biochemistry: Alkaline Phosphatase (AP)|Change from baseline (week 0) in AP was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||U/L||Standard Deviation|Mean
2559837|NCT02670915|Secondary|Change in Biochemistry: Aspartate Aminotransferase (AST)|Change from baseline (week 0) in AST was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||U/L||Standard Deviation|Mean
2559838|NCT02670915|Secondary|Change in Biochemistry: Alanine Aminotransferase (ALT)|Change from baseline (week 0) in ALT was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||U/L||Standard Deviation|Mean
2559839|NCT02670915|Secondary|Change in Biochemistry: Creatinine|Change from baseline (week 0) in creatinine was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||umol/L||Standard Deviation|Mean
2559840|NCT02670915|Secondary|Change in Haematology: Leukocytes|Change from baseline (week 0) in leukocytes was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||10^9 cells/L||Standard Deviation|Mean
2559841|NCT02670915|Secondary|Change in Haematology: Thrombocytes|Change from baseline (week 0) in thrombocytes was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||10^9 cells/L||Standard Deviation|Mean
2559842|NCT02670915|Secondary|Change in Haematology: Erythrocytes|Change from baseline (week 0) in erythrocytes was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||10^12 cells/L||Standard Deviation|Mean
2559869|NCT02670915|Secondary|Change in IG Peak After Start of Meal|Change in IG peak after start of meal during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2559843|NCT02670915|Secondary|Change in Haematology: Haematocrit|Change from baseline (week 0) in haematocrit was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||% of red blood cells||Standard Deviation|Mean
2559844|NCT02670915|Secondary|Change in Haematology: Haemoglobin|Change from baseline (week 0) in haemoglobin was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||mmol/L||Standard Deviation|Mean
2559845|NCT02670915|Secondary|Change in SD Score of Body Mass Index|Change from baseline (week 0) in SD score of BMI was evaluated after 26 weeks of randomisation. SD scores for BMI were determined in a similar way as SD scores for weight by use of a suitable reference population based on age and sex. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Standard deviation score||Standard Deviation|Mean
2559846|NCT02670915|Secondary|Change in SD Score of Body Weight|Change from baseline (week 0) in standard deviation (SD) score of body weight was evaluated after 26 weeks of randomisation. SD-scores are defined to be able to normalise the body weight in the various age groups. To estimate the growth of children, standardised weight is calculated for each year of age and for each sex. Thus, a child with a weight equal to the mean value for its age and sex has an SD score of 0, while a child with a weight 2 SDs above the mean value for its age and sex has an SD score of +2. The SD scores are derived from the age and sex of the subjects and the body weight together with growth curves defined for a reference population. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Standard deviation score||Standard Deviation|Mean
2559847|NCT02670915|Secondary|Change in Body Mass Index|Change from baseline (week 0) in body mass index (BMI) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||kg/m^2||Standard Deviation|Mean
2559848|NCT02670915|Secondary|Change in Height|Change from baseline (week 0) in height was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Meter||Standard Deviation|Mean
2559849|NCT02670915|Secondary|Change in Body Weight|Change from baseline (week 0) in body weight was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed at baseline= Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||kg||Standard Deviation|Mean
2559850|NCT02670915|Secondary|Change in Vital Sign: Pulse|Change from baseline (week 0) in pulse was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Beats/minute||Standard Deviation|Mean
2559851|NCT02670915|Secondary|Change in Vital Sign: Blood Pressure|Change from baseline (week 0) in blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP)) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||mmHg||Standard Deviation|Mean
2559861|NCT02670915|Secondary|Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification|Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.|Week 0-26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Episodes|||Number
2559852|NCT02670915|Secondary|Change in Physical Examination|The following physical examinations were done: 1) Cardiovascular system. 2) Central and peripheral nervous system. 3) Gastrointestinal system including the mouth. 4) General appearance. 5) Head, ears, eyes, nose, throat and neck. 6) Musculoskeletal system. 7) Respiratory system. 8) Skin. Presented results are number of participants with the following outcomes: normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS). Presented results are baseline (week 0) and last on-treatment values. Number of participants analysed = number of participants contributed to the analysis.|Week 0, Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Participants|||Number
2559853|NCT02670915|Secondary|Number of Treatment Emergent Injection Site Reactions|Treatment emergent was defined as an event that has onset up to 7 days after last day of IMP and excluding the events occurring in the run-in period. The results are based on the on-treatment period.|Week 0-26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Events|||Number
2559854|NCT02670915|Secondary|Number of Treatment Emergent Adverse Events (AEs)|Treatment emergent was defined as an event that has onset up to 7 days after last day of IMP (faster aspart or NovoRapid®/NovoLog®) and excluding the events occurring in the run-in period. The results are based on the on-treatment period.|Week 0-26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Events|||Number
2559855|NCT02670915|Secondary|Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification|Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.|Week 0-26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Episodes|||Number
2559856|NCT02670915|Secondary|Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification|Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.|Week 0-26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Episodes|||Number
2559857|NCT02670915|Secondary|Number of Treatment Emergent Meal Related (From Start of Meal Until 2 Hours After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification|Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.|Week 0-26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Episodes|||Number
2559858|NCT02670915|Secondary|Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification|Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. The results are based on the on-treatment period.|Week 0-26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Episodes|||Number
2559859|NCT02670915|Secondary|Number of Treatment Emergent Meal Related (From 2-4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification|Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.|Week 0-26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Episodes|||Number
2559860|NCT02670915|Secondary|Number of Treatment Emergent Meal Related (From Start of Meal Until 4 Hours After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification|Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.|Week 0-26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Episodes|||Number
2559986|NCT02669758|Primary|Number of Participants With Adverse Events (AEs)||Up to 52 weeks|Safety population includes all subjects who received at least one dose of study drug.|||Participants|||Count of Participants
2559862|NCT02670915|Secondary|Number of Treatment Emergent Meal Related (From Start of Meal Until 1 Hour After Start of Meal) Hypoglycaemic Episodes According to ADA/ISPAD Classification|Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. The results are based on the on-treatment period.|Week 0-26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Episodes|||Number
2559863|NCT02670915|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Nocturnal (23:00-7:00, Both Included)|Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. Nocturnal period: The period between 23:00 and 07:00 (both included). The results are based on the on-treatment period.|Week 0-26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Episodes|||Number
2559864|NCT02670915|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Daytime|Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) BG confirmed. 3) Severe or BG confirmed symptomatic. 4) Severe or BG confirmed. 5) Asymptomatic BG confirmed. Daytime period: The period between 07:01 and 22:59 (both included). The results are based on the on-treatment period.|Week 0-26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Episodes|||Number
2559865|NCT02670915|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to Novo Nordisk/ISPAD Classification: Total|Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to Novo Nordisk classification: 2) Symptomatic blood glucose (BG) confirmed: episode that is BG confirmed by PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. 3) Asymptomatic BG confirmed: episode that is BG confirmed by PG value <3.1 mmol/L without symptoms consistent with hypoglycaemia. 4) Severe or BG confirmed symptomatic: an episode that is severe according to the ISPAD classification or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. 5) BG confirmed: an episode that is BG confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 6) Severe or BG confirmed: an episode that is severe according to the ISPAD Classification or BG confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. The results are based on the on-treatment period.|Week 0-26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Episodes|||Number
2559866|NCT02670915|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Nocturnal (23:00-7:00, Both Included)|Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. Nocturnal period: The period between 23:00 and 07:00 (both included). The results are based on the on-treatment period.|Week 0-26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Episodes|||Number
2559867|NCT02670915|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to ADA/ISPAD Classification: Daytime|Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic. 3) Asymptomatic. 4) Probable symptomatic. 5) Pseudo-hypoglycaemia. Daytime period: The period between 07:01 and 22:59 (both included). The results are based on the on-treatment period.|Week 0-26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Episodes|||Number
2559868|NCT02670915|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA)/ISPAD Classification: Total|Treatment emergent: if the onset of the episode occurred on or after the first day of treatment with investigational medicinal product (IMP) after randomisation, and no later than 1 day after the last day on IMP. Classification of hypoglycaemia: 1) Severe (according to ISPAD classification). Following are according to ADA classification: 2) Documented symptomatic: episode during which typical symptoms of hypoglycaemia are accompanied by a PG level ≤3.9 mmol/L. 3) Asymptomatic: episode not accompanied by typical symptoms of hypoglycaemia, but with a PG level ≤3.9 mmol/L. 4) Probable symptomatic: an episode during which symptoms of hypoglycaemia are not accompanied by a PG determination but that was presumably caused by a PG level ≤3.9 mmol/L. 5) Pseudo-hypoglycaemia: episode during which the person with diabetes reports any of the typical symptoms of hypoglycaemia with a PG level >3.9mmol/L, but approaching that level. The results are based on the on-treatment period.|Week 0-26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Episodes|||Number
2559933|NCT02670473|Primary|Lens Fit - Centration|Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable.|Baseline, 1 week, 2 weeks, and 4 weeks||||percentage of eyes|||Number
2559870|NCT02670915|Secondary|Change in Time to the IG Peak After Start of Meal|Change in time to the IG peak after start of meal during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||Minute||Standard Deviation|Mean
2559871|NCT02670915|Secondary|Change in AUCIG,0-4h|Change in area under the IG curve 0-4 hours post meal (AUCIG,0-4h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2559872|NCT02670915|Secondary|Change in AUCIG,0-2h|Change in area under the IG curve 0-2 hours post meal (AUCIG,0-2h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2559873|NCT02670915|Secondary|Change in AUCIG,0-1h|Change in area under the IG curve 0-1 hour post meal (AUCIG,0-1h) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2559874|NCT02670915|Secondary|Change in AUCIG,0-30min|Change in area under the IG curve 0-30 minutes post meal (AUCIG,0-30min) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. IG was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2559875|NCT02670915|Secondary|Change in AUCIG,0-15min|Change in area under the IG curve 0-15 minutes post meal (AUCIG,0-15min) during meal test and based on CGM measurements was evaluated after 26 weeks of randomisation. Interstitial glucose (IG) was measured every 5 minutes. The endpoint was calculated as the area under the IG curve using the trapezoidal method and weighted by duration. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2559876|NCT02670915|Secondary|Change in 2-hour PPG Increment|Change from baseline (week 0) in 2-hour PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 2-hour (after the meal) at the visit. PPG increment was derived as 2-hour PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2559877|NCT02670915|Secondary|Change in 2-hour PPG|Change from baseline (week 0) in 2-hour PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 2-hour after the meal intake at the visit. The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2559878|NCT02670915|Secondary|Change in 1-hour PPG Increment|Change from baseline (week 0) in 1-hour PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 1-hour (after the meal) at the visit. PPG increment was derived as 1-hour PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2559879|NCT02670915|Secondary|Change in 1-hour PPG|Change from baseline (week 0) in 1-hour PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 1-hour after the meal intake at the visit. The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2559880|NCT02670915|Secondary|Change in 30-minute PPG Increment|Change from baseline (week 0) in 30-minute PPG increment based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the pre-prandial glucose (before the meal) the PPG at 30-minute (after the meal) at the visit. PPG increment was derived as 30-minute PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2561396|NCT02650921|Secondary|Evaluate GAIS by Subjects|Global Aesthetic Improvement Scale|12 weeks|ITT|||Participants|||Count of Participants
2559881|NCT02670915|Secondary|Change in 30-minute PPG|Change from baseline (week 0) in 30-minute PPG based on meal test was evaluated after 26 weeks of randomisation. In connection to wearing the CGM for 11 to 13 days up to week 0 and up to week 26, the subgroup of participants had a standardised liquid meal test at the 2 visits, monitoring the PPG at 30-minute after the meal intake at the visit. The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2559882|NCT02670915|Secondary|Change in Mean Time to the IG Peak After Meal|Change from baseline (week 0) in mean time to the IG peak after meal based on CGM was evaluated after 26 weeks of randomisation. A subgroup of subjects wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||Minutes||Standard Deviation|Mean
2559883|NCT02670915|Secondary|Change in Mean IG Peak After Start of Meal|Change from baseline (week 0) in mean IG peak after start of meal based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2559884|NCT02670915|Secondary|Change in Mean IG Increment (0-1 Hours and 0-2 Hours After Start of the Meal)|Change from baseline (week 0) in mean IG increment (0-1 hours and 0-2 hours after start of the meal) based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. Presented values are mean of all the meals (breakfast, lunch and evening meal). The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2559885|NCT02670915|Secondary|Percentage of Time Spent Within IG Target 4.0-10.0 mmol/L (71-180 mg/dL) Both Included|Percentage of time spent within IG target 4.0-10.0 mmol/L (71-180 mg/dL), both included based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.|Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||Percentage of time||Standard Deviation|Mean
2559886|NCT02670915|Secondary|Percentage of Time Spent With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL)|Percentage of time spent with IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) based on CGM was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.|Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||Percentage of time||Standard Deviation|Mean
2559887|NCT02670915|Secondary|Incidence of Episodes With IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL)|Incidence of episodes (number of episodes per 24 hours) with IG <=2.5, 3.0, 3.9 mmol/L (45, 54, 70 mg/dL) and IG >10.0, 12.0 mmol/L (180, 216 mg/dL) based on CGM was calculated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.|Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||Episodes per 24 hours|||Number
2559888|NCT02670915|Secondary|Change of Time Spent in Low Interstitial Glucose (IG) (IG <=3.9 mmol/L [70 mg/dL])|Change from baseline (week 0) in the time spent in low IG (<=3.9 mmol/L [70 mg/dL]) based on continuous glucose monitoring (CGM) was evaluated after 26 weeks of randomisation. A subgroup of participants wore a CGM for between 11 and 13 days up to week 0 (randomisation) and up to week 26 to monitor their IG on a continuous basis. The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||Minutes/day||Standard Deviation|Mean
2559889|NCT02670915|Secondary|Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose|Individual meal (breakfast, lunch and main evening meal) insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Units (U)/kg||Standard Deviation|Mean
2559890|NCT02670915|Secondary|Insulin Dose (Units/kg/Day): Total Bolus|Total bolus insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Units (U)/kg||Standard Deviation|Mean
2559891|NCT02670915|Secondary|Insulin Dose (Units/kg/Day): Total Basal|Total basal insulin dose (Units/kg/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Units (U)/kg||Standard Deviation|Mean
2560135|NCT02668198|Primary|Positive Recurrent Adenomas Using White Light Imaging Confirmed by Histology|The number of recurrent adenomas diagnosed positive with white light imaging confirmed by standard histopathology of biopsy.|approximately 6 to 12 months post endoscopic mucosal resection||||adenomas confirmed positive diagnoses|||Number
2559892|NCT02670915|Secondary|Insulin Dose (Units/Day): Individual Meal Insulin Dose|Individual meal (breakfast, lunch and main evening meal) insulin dose (Units/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value.|Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Units (U)||Standard Deviation|Mean
2559893|NCT02670915|Secondary|Insulin Dose (Units/Day): Total Bolus|Total bolus insulin dose (Units/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value. Number of participants analysed = number of participants contributed to the analysis.|Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Units (U)||Standard Deviation|Mean
2559894|NCT02670915|Secondary|Insulin Dose (Units/Day): Total Basal|Total basal insulin dose (Units/day) was evaluated after 26 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period: the observation period from date of first dose of randomised NovoRapid®/NovoLog® / faster aspart and no later than 7 days after the day of last dose of NovoRapid®/NovoLog® / faster aspart. The on-treatment observation period includes data collected up to and including 7 days after treatment discontinuation. Number of participants analysed = number of participants contributed to the analysis. Analysis population description: Safety analysis set (SAS) included all participants receiving at least one dose of the investigational product (faster aspart) or its comparator (NovoRapid®/NovoLog®).|Week 26|SAS. One participant was randomised to the postmeal faster aspart group but was exposed to mealtime faster aspart throughout the study. The participant was included in the mealtime faster aspart group for the SAS. Therefore, number of participants analysed = Faster aspart (meal): 261, Faster aspart (post): 258 and NovoRapid (meal): 258.|||Units (U)||Standard Deviation|Mean
2559895|NCT02670915|Secondary|Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines, Without Severe Hypoglycaemia|Percentage of participants (yes/no) reaching HbA1c less than 7.5 % according to ISPAD guidelines, without severe hypoglycaemia was evaluated after 26 weeks of randomisation. Severe hypoglycaemia according to ISPAD guidelines: hypoglycaemic episode associated with severe neuroglycopenia, usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose). The results are based on the last in-trial value.|Week 26|FAS.|||Percentage of participants|||Number
2559896|NCT02670915|Secondary|Percentage of Subjects Reaching HbA1c Target (HbA1c Less Than 7.5 %) According to ISPAD Guidelines|Percentage of participants (yes/no) reaching HbA1c less than 7.5 % according to International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value.|Week 26|FAS.|||Percentage of participants|||Number
2559897|NCT02670915|Secondary|Change in 1,5-anhydroglucitol|Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||ug/mL||Standard Deviation|Mean
2559898|NCT02670915|Secondary|Change in FPG|Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2559899|NCT02670915|Secondary|Fluctuation in the 8-point SMPG Profile|Fluctuation in the 8-point SMPG profile was evaluated after 26 weeks of randomisation. Fluctuation in 8-point SMPG profile was the average absolute difference from the mean of the SMPG profile. The results are based on the last in-trial value.|Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Geometric Coefficient of Variation|Geometric Mean
2559900|NCT02670915|Secondary|Change in 8-point SMPG Profile: Mean of the 8-point Profile|Change from baseline (week 0) in mean of the 8-point SMPG profile was evaluated after 26 weeks of randomisation. SMPG values were recorded at 8 time-points on two consecutive days: before and after (60 minute after the start of the meal) breakfast, lunch and main evening meal, before bedtime, and before breakfast on the next day. Mean of the 8-point profile was derived as the mean of all corresponding mean SMPG recorded at 8 different time points. The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2559901|NCT02670915|Secondary|Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG Increment|Change from baseline (week 0) in individual meal (breakfast, lunch and main evening meal) PPG increment was evaluated after 26 weeks of randomisation. PPG increment for each meal was derived from the 8-point profile as the difference between PPG values (1 hour after the meal) and the PG value before meal. The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2559902|NCT02670915|Secondary|Change in 8-point SMPG Profile: Individual Meal (Breakfast, Lunch and Main Evening Meal) PPG|Change from baseline (week 0) in individual meal (breakfast, lunch and main evening meal) PPG was evaluated after 26 weeks of randomisation. PPG for each meal was recorded by the participant as part of the 8-point SMPG profile. The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2559903|NCT02670915|Secondary|Change in 8-point SMPG Profile: PPG Increment Over All Three Meals|Change from baseline (week 0) in mean PPG increment over all three meals was evaluated after 26 weeks of randomisation. Postprandial glucose (PPG) increment for each meal (breakfast, lunch and main evening meal) was derived from the 8-point profile as the difference between PPG (1 hour after the meal) values and the plasma glucose (PG) value before meal. The mean of the derived increments was then calculated separately for each meal. Mean PPG increment over all three meals was derived as the mean of all corresponding mean meal increments. The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis. .|||mmol/L||Standard Deviation|Mean
2559904|NCT02670915|Secondary|Change in 8-point SMPG Profile: Mean PPG Over All Three Meals|Change from baseline (week 0) in mean post prandial glucose (PPG) over all three meals was evaluated after 26 weeks of randomisation. PPG for each meal (breakfast, lunch and main evening meal) was recorded by the participant as part of the 8-point self-measured plasma glucose (SMPG) profile. Mean PPG over all three meals was derived as the mean of all corresponding mean meal. The results are based on the last in-trial value.|Week 0, Week 26|FAS. Number of participants analysed = number of participants contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2559905|NCT02670915|Primary|Change in the Percentage of HbA1c|Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related participant-site contact and included data collected after a subject discontinued trial product.|Week 0, Week 26|Full analysis set (FAS), which included all randomised participants. Number of participants analysed = number of participants contributed to the analysis.|||Percentage of HbA1c||Standard Deviation|Mean
2559906|NCT02670811|Secondary|Triglycerides Measurements|Triglycerides measurements in baseline and after 8 weeks of treatment (intake period).|Baseline and 8th week||||mg/dL||Standard Deviation|Mean
2559907|NCT02670811|Secondary|High Density Lipoproteins|High density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period).|Baseline and 8th week||||mg/dL||Standard Deviation|Mean
2559908|NCT02670811|Secondary|Low Density Lipoproteins Measurements|Low density lipoproteins measurements in baseline and after 8 weeks of treatment (intake period).|Baseline and 8th week||||mg/dL||Standard Deviation|Mean
2559909|NCT02670811|Secondary|Total Cholesterol Measurements|Total cholesterol in baseline and after 8 weeks of treatment (Intake period).|Baseline and 8th week||||mg/dL||Standard Deviation|Mean
2559910|NCT02670811|Secondary|Diastolic Blood Pressure Measurements|From randomization (baseline), eight weeks of intervention and two weeks post-treatment.|Baseline to 10 weeks||||mmHg||Standard Deviation|Mean
2559911|NCT02670811|Primary|Systolic Blood Pressure Measurements|From randomization (baseline), eight weeks of intervention and two weeks after intervention was over.|Baseline to 10 weeks||||mmHg||Standard Deviation|Mean
2559912|NCT02670629|Primary|Patients With Residual Radiographic Deformities Obtained in Both Groups.|The cast was removed afer 6 weeks and rehabilitation in house was started as soon as the pain was over. The simple X rays were evaluated with the Montoya Classification, which stratifies the patients with regards of time until radiographic consolidation and bone remodeling. The radial tilt, radial shortening and radial variation was recorded and compared with the control group. This radiologic measures were reported in terms of degrees and millimeters were needed.|10 weeks||||participants|||Number
2559913|NCT02670629|Other Pre-specified|Aesthetic Results Measured by Clinical Radial Alignment in Degrees in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction in Comparison to Those Treated With Anatomical Reduction in Both Groups.|Patients were evaluated in comparison to the other extremity in terms of clinically evident deformity and appearance. Varus, Valgus, antecurvatum and recurvatum was measured and recorded appropriately. This was later compared to the data obtained in those patients who were treated with an anatomic reduction.|10 weeks||||degrees||Standard Deviation|Mean
2559914|NCT02670629|Secondary|Residual Functional Deficits Assessed by the UEFI (Upper Extremity Functional Index)in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction.|"Patients were evaluated using a modified Upper Extremity Functional Index (UEFI) scale fot the appropriate age in order to assess functional deficits in the fractured limb in patients with distal radius fractures treated without an anatomical reduction.~Evaluates the impairment the subject perceives they encounter when performing 20 types of activities of daily living. Each of the 20 actions in the UEFI is evaluated on a 5-point scale.~Minimum Value 0 maximum value 4 per action, where 0 indicates most severe limitation and 80 suggests least limitation."|10 weeks||||units on a scale||Standard Deviation|Mean
2559915|NCT02670629|Secondary|Pain Assessed by the Visual Analogue Scale (VAS) in Patients With Distal Radius Fractures Treated Without an Anatomical Reduction in Comparison to Those Treated With Anatomical Reduction.|"The Visual Analogue Scale (VAS) was used in order to assess the residual pain in the experimental group, this is, in patients with distal radius fractures treated without an anatomical reduction, this was later compared to the results obtained in the group in which a reduction was performed.~Minimum value 0 maximum value 10. Higher score means a worse outcome."|10 weeks||||units on a scale||Standard Deviation|Mean
2559916|NCT02670629|Primary|Radial Shortening in Degrees - Residual Radiographic Deformities in Terms of the Radial Tilt, Radial Shortening and Radial Variation, Obtained in Both Groups.|The cast was removed afer 6 weeks and rehabilitation in house was started as soon as the pain was over. The simple X rays were evaluated with the Montoya Classification, which stratifies the patients with regards of time until radiographic consolidation and bone remodeling. The radial tilt, radial shortening and radial variation was recorded and compared with the control group. This radiologic measures were reported in terms of degrees and millimeters were needed.|10 weeks||||degrees||Standard Deviation|Geometric Mean
2559917|NCT02670551|Secondary|Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 6|"The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of other participants the physician has observed. The participant was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating among the most extremely ill participants. A negative change from Baseline indicates improvement."|Baseline (Week 0) to Week 6|ITT Population included all participants from the safety population who had at least 1 postbaseline assessment of the MADRS total score. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
2559987|NCT02669667|Secondary|Number of Participants Positive for Anti-Drug Antibodies to MEDI9314|Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9314. The number of participants with positive serum antibodies to MEDI9314 were presented.|Baseline (Day 1 [predose]) and Day 240|As-treated population included participants who received any study drug and summarized according to the treatment they actually received.|||Participants|||Count of Participants
2559918|NCT02670551|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Week 6|The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants were rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each of the 10 items was scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement.|Baseline (Week 0) to Week 6|The Intent-to-Treat (ITT) Population included all participants from the safety population who had at least 1 postbaseline assessment of the MADRS total score. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
2559919|NCT02670538|Secondary|Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score|"CGI-S is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of other patients the physician has observed. The participant was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating among the most extremely ill patients. A negative change from Baseline indicates improvement. MMRM with fixed factors (treatment group, pooled study center, and visit), baseline (a covariate), and interactions (treatment group by visit, baseline by visit)."|Baseline (Week 0) to Week 6|ITT population consisted of all participants in Safety Population who had at least 1 postbaseline assessment of MADRS total score.|||score on a scale||Standard Error|Least Squares Mean
2559920|NCT02670538|Primary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)|MADRS is a 10-item, clinician-rated scale that evaluates the participants depressive symptomatology during the past week. Participants were rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each of the 10 items was scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Mixed-effects Model for Repeated Measures (MMRM) with fixed factors (treatment group, pooled study center, and visit), baseline (a covariate), and interactions (treatment group by visit, baseline by visit).|Baseline (Week 0) to Week 6|ITT Population consisted of all participants in Safety Population who had at least 1 postbaseline assessment of MADRS total score.|||score on a scale||Standard Error|Least Squares Mean
2559921|NCT02670473|Secondary|Corneal Staining|Corneal staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0.5 steps 0=normal, 4=severe.|Baseline, 1 week, 2 weeks, and 4 weeks||||percentage of eyes|||Number
2559922|NCT02670473|Secondary|Conjunctival Staining|Conjunctival staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. (Scale 0-4, 0.5 steps 0=normal, 4=severe).|Baseline, 1 week, 2 weeks, and 4 weeks||||percentage of eyes|||Number
2559923|NCT02670473|Secondary|Wearing Times|Average wearing time and comfortable wearing times for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks measured by hours.|Baseline, 1 week, 2 weeks, and 4 weeks||||hours||Standard Deviation|Mean
2559924|NCT02670473|Secondary|Lens Preference Overall|Subject's overall preference for one of two contact lenses. Forced choice: enfilcon A habitual lens (control) or fanfilcon A lens (test).|1 week, 2 weeks, and 4 weeks|One participant withdrew from the study after week 1.|||percentage of subjects|||Number
2559925|NCT02670473|Secondary|Overall Satisfaction|Subjective rating of overall satisfaction for enfilcon A habitual lens (control) at baseline and fanfilcon A lens (test) at 1 week, 2 weeks, and 4 weeks. Scale 1-4, 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied.|Baseline, 1 week, 2 weeks, and 4 weeks|One participant withdrew from the study after week 1.|||percentage of subjects|||Number
2559926|NCT02670473|Secondary|Overall Vision Satisfaction|Subjective rating of overall vision satisfaction for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dissatisfied, 10=very satisfied.|Baseline, 1 week, 2 weeks, and 4 weeks||||units on a scale||Standard Deviation|Mean
2559927|NCT02670473|Secondary|Handling|Subjective rating of handling for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.|Baseline, 1 week, 2 weeks, and 4 weeks||||units on a scale||Standard Deviation|Mean
2559928|NCT02670473|Secondary|Dryness Overall|Subjective rating of overall dryness for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dry, 10=no dryness.|Baseline, 1 week, 2 weeks, and 4 weeks||||units on a scale||Standard Deviation|Mean
2559929|NCT02670473|Secondary|Overall Comfort|Subjective rating of overall comfort for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=could feel, 10=cannot feel.|Baseline, 1 week, 2 weeks, and 4 weeks||||units on a scale||Standard Deviation|Mean
2559930|NCT02670473|Primary|Overall Fit Acceptance|Overall fit acceptance for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect.|Baseline, 1 week, 2 weeks, and 4 weeks||||percentage of eyes|||Number
2559931|NCT02670473|Primary|Lens Tightness on Push-up|Lens fit evaluation of tightness on push-up test for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: 0%-100%, 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement.|Baseline, 1 week, 2 weeks, and 4 weeks||||percentage of lens tightness||Standard Deviation|Mean
2559932|NCT02670473|Primary|Lens Fit - Post-blink Movement|Lens fit evaluation of post-blink movement for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-5 Likert scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement.|Baseline, 1 week, 2 weeks, and 4 weeks||||percentage of eyes|||Number
2559934|NCT02670343|Primary|% of Mean Difference in T Concentration Compared to Plain Collection Tube|"The measured outcome presented is the difference as a percent of mean of T results when comparing T Concentrations measured in three different types of NaF containing collection tubes (NaF+EDTA, NaF+Oxalate and NaF) to T measured in blood collected in plain tubes. The % of Mean Difference in T concentration for each tube type was obtained by taking the average at each time point a T concentration was obtained, and calculating the mean difference between the test ((NaF+EDTA, NaF+Oxalate and NaF) tubes and the control (plain) tube.~The concentration of total T will be determined in the serum/plasma samples of all subjects using validated LC/MS/MS methods at the Endocrine and Metabolic Research Lab."|Sample collection at -0.5, and 0 hours pre-dose and post-dose samples collected at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12, hours after a single dose of oral TU.||||Difference as % of Mean of T results||Standard Deviation|Mean
2559935|NCT02670330|Secondary|Change From Baseline In BSAI Of Total Body Wound Burden Up To Month 30|"A wound was defined as an open area on the skin (that is, epidermal covering disrupted). Total body wound burden was calculated using BSAI; the percentage, ranging from 0% to 100%, of affected BSA was recorded for each defined body region (that is, head/neck, upper limbs, trunk [includes groin], and lower limbs), multiplied by the weighting factor, then summed for all body regions to calculate the BSAI that would range from 0% to 100%. The BSAI for total body wound burden was to be assessed by the same study physician at each visit for a particular participant.~The mean change from baseline in total body wound burden was assessed every 3 months. Only participants with data available for analysis at each time point are presented."|Baseline, up to Month 30|Intent-to-treat (ITT) population: all participants who rolled over from Study SD-005 and had data available for analysis at each specified time point.|||Percentage of BSAI||Standard Deviation|Mean
2559936|NCT02670330|Secondary|Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin Up To Month 30|Lesional skin was defined as areas that contained any of the following: blisters, erosions, ulcerations, scabbing, bullae, or eschars, as well as areas that were weeping, sloughing, oozing, crusted, or denuded. The percentage, ranging from 0% to 100%, of affected body surface area (BSA) was recorded for each defined body region (that is, head/neck, upper limbs, trunk [includes groin], and lower limbs), multiplied by the weighting factor, then summed for all body regions to calculate the BSAI that would range from 0% to 100%. The BSA for lesional skin was to be assessed by the same study physician on each visit for a particular participant. The mean change from baseline in BSAI was assessed every 3 months. Only participants with data available for analysis at each time point are presented.|Baseline, up to Month 30|Intent-to-treat (ITT) population: all participants who rolled over from Study SD-005 and had data available for analysis at each specified time point.|||Percentage of BSAI||Standard Deviation|Mean
2559937|NCT02670330|Primary|Number Of Participants With Treatment Emergent Adverse Events (TEAEs)|TEAEs were defined as adverse events that started or worsened on or after baseline visit.|From baseline to 30 days after last application of study drug (up to a maximum of 37 months)|Safety Population: all participants who applied/were administered the study drug at least once.|||Participants|||Count of Participants
2559938|NCT02669940|Other Pre-specified|Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis|Virologic response is defined as HCV RNA < 50 IU/mL or undetectable/negative.|From baseline until end of treatment (12 or 24 weeks after actual first dose)|Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.|||percentage of participants||95% Confidence Interval|Number
2559939|NCT02669940|Other Pre-specified|Percentage of Participants Achieving SVR24: Additional Analysis|SVR24 is defined as HCV RNA levels < 50 IU/mL or undetectable/negative 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.|24 weeks after last actual dose of study drug|Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.|||percentage of participants||95% Confidence Interval|Number
2559940|NCT02669940|Other Pre-specified|SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis|Relapse is defined as HCV RNA < 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL or positive posttreatment.|12 weeks after last actual dose of study drug|Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.|||percentage of participants||95% Confidence Interval|Number
2559941|NCT02669940|Other Pre-specified|SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis|Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.|12 weeks after the last actual dose of study drug|Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.|||percentage of participants||95% Confidence Interval|Number
2559942|NCT02669940|Other Pre-specified|SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis|Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL or undetectable/negative followed by HCV RNA ≥50 IU/mL or positive during treatment.|12 weeks after the last actual dose of study drug|Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.|||percentage of participants||95% Confidence Interval|Number
2560000|NCT02669615|Secondary|Transplant-Related Mortality (TRM) Following Autologous Stem-Cell Transplantation (ASCT)|TRM will be summarized descriptively (death within 100 days without relapse following ASCT).|100 days||||Participants|||Count of Participants
2561397|NCT02650921|Secondary|GAIS by Treating Investigator|Global Aesthetic Improvement Scale|24 weeks|ITT|||Participants|||Count of Participants
2559943|NCT02669940|Other Pre-specified|Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis|Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL or undetectable/negative followed by HCV RNA ≥50 IU/mL or positive during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive. Relapse is defined as HCV RNA < 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL or positive posttreatment.|12 weeks after last actual dose of study drug|Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.|||percentage of participants||95% Confidence Interval|Number
2559944|NCT02669940|Other Pre-specified|Percentage of Participants Achieving SVR12: Additional Analysis|SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL or undetectable/negative 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.|12 weeks after the last actual dose of study drug|Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for >55 days (for 12-week treatment) or >139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.|||percentage of participants||95% Confidence Interval|Number
2559945|NCT02669940|Secondary|Percentage of Participants Achieving Virological Response at End of Treatment|Virologic response is defined as HCV RNA < 50 IU/mL.|From baseline until end of treatment (12 or 24 weeks after actual first dose)|Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.|||percentage of participants||95% Confidence Interval|Number
2559946|NCT02669940|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)|SVR24 is defined as HCV RNA levels < 50 IU/mL 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.|24 weeks after last actual dose of study drug|Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.|||percentage of participants||95% Confidence Interval|Number
2559947|NCT02669940|Secondary|SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data||12 weeks after last actual dose of study drug|Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment).|||percentage of participants||95% Confidence Interval|Number
2559948|NCT02669940|Secondary|SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure|On-treatment virologic failure included virological breakthrough and failure to suppress. Virological breakthrough was defined as at least one documented HCV RNA < 50 IU/mL or undetectable/negative followed by HCV RNA ≥ 50 IU/mL during treatment. Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.|12 weeks after last actual dose of study drug|Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.|||percentage of participants||95% Confidence Interval|Number
2559949|NCT02669940|Secondary|SVR12 Non-Response: Percentage of Participants With Relapse|Relapse is defined as HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment.|12 weeks after last actual dose of study drug|Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.|||percentage of participants||95% Confidence Interval|Number
2559950|NCT02669940|Secondary|SVR12 Non-Response: Percentage of Participants With Failure to Suppress|Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.|12 weeks after the last actual dose of study drug|Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.|||percentage of participants||95% Confidence Interval|Number
2559951|NCT02669940|Secondary|SVR12 Non-Response: Percentage of Participants With Breakthrough|Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment.|12 weeks after the last actual dose of study drug|Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.|||percentage of participants||95% Confidence Interval|Number
2559952|NCT02669940|Secondary|Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse|Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL. Relapse is defined as HCV RNA < 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment.|12 weeks after last actual dose of study drug|Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.|||percentage of participants||95% Confidence Interval|Number
2559953|NCT02669940|Primary|Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12)|SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.|12 weeks after the last actual dose of study drug|Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for >55 days (for 12-week treatment) or >139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.|||percentage of participants||95% Confidence Interval|Number
2559954|NCT02669914|Secondary|Overall Survival (OS)|-Defined as the interval from the start of study therapy to death from any cause|Up to 2 years after completion of treatment (estimated to be 2 years and 6 months)|One participant in Cohort A was lost to follow-up and is not evaluable for this outcome measure. There were not any participants enrolled to Cohort B or Cohort C.|||days||Full Range|Median
2559955|NCT02669914|Secondary|Progression-free Survival (PFS)|"PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.~At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Unequivocal progression of existing non-target lesions."|Up to 2 years after completion of treatment (estimated to be 2 years and 6 months)|There were not any participants enrolled in Cohort B or Cohort C.|||days||Full Range|Median
2559956|NCT02669914|Secondary|Duration of Response Considering Both Intracranial and Extracranial Disease|"Defined as the interval from the first documentation of objective response (complete response or partial response) to the earlier of the first documentation of disease progression or death from any cause~Intracranial disease: response and progression will be evaluated using the updated response assessment criteria for high-grade gliomas: Response Assessment in Neuro-Oncology (RANO) working group guideline~Extracranial disease: response and progression will be evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)"|Completion of treatment (estimated to be 6 months)|Two participants were not evaluable in Cohort A as the extracranial response per RECIST was not done. The remaining two participants were not evaluable for this outcome measure because they didn't have an objective response. There were not any participants enrolled in Cohort B or Cohort C.||||||
2559957|NCT02669914|Secondary|Duration of Response of Extracranial Disease|"Defined as the interval from the first documentation of objective response (complete response or partial response) to the earlier of the first documentation of disease progression or death from any cause~Extracranial disease: response and progression will be evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)"|Completion of treatment (estimated to be 6 months)|Two participants were not evaluable in Cohort A as the extracranial response per RECIST was not done. The remaining two participants were not evaluable for this outcome measure because they didn't have an objective response per RECIST. There were not any participants enrolled in Cohort B or Cohort C.||||||
2559958|NCT02669914|Secondary|Duration of Response of Intracranial Disease|"Defined as the interval from the first documentation of objective response (complete response or partial response) to the earlier of the first documentation of disease progression or death from any cause~Intracranial disease: response and progression will be evaluated using the updated response assessment criteria for high-grade gliomas: Response Assessment in Neuro-Oncology (RANO) working group guideline"|Completion of treatment (estimated to be 6 months)|None of the participants in Cohort A were evaluable for this outcome measure as they did not have an objective response per RANO guidelines. There were not any participants enrolled to Cohort B or Cohort C.||||||
2559959|NCT02669914|Secondary|Overall Disease Control Rate Considering Both Intracranial and Extracranial Disease|"Defined as the percentage of subjects who achieve a complete response, partial response, or stable disease based on assessment of brain and systemic lesions~Intracranial disease: response and progression will be evaluated using the updated response assessment criteria for high-grade gliomas: Response Assessment in Neuro-Oncology (RANO) working group guideline~Extracranial disease: response and progression will be evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)"|Completion of treatment (estimated to be 6 months)|Two participants were not evaluable in Cohort A as the extracranial response per RECIST was not done. There were not any participants enrolled in Cohort B or Cohort C.|||Participants|||Count of Participants
2559960|NCT02669914|Secondary|Overall Response Rate Considering Both Intracranial and Extracranial Disease|"Defined as the percentage of patients who achieve a complete response or partial response based on assessment of brain and systemic lesions~Intracranial disease~Complete response: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters~Extracranial disease~Complete response: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters"|Completion of treatment (estimated to be 6 months)|Two participants were not evaluable in Cohort A as the extracranial response per RECIST was not done. There were not any participants enrolled in Cohort B or Cohort C.|||Participants|||Count of Participants
2559972|NCT02669849|Secondary|Percentage of Motor Level Responders|The motor level score for the right or left side assesses contraction strength of 10 key muscles in the upper and lower extremities on each side of the body; each muscle receives a score from 0 (total paralysis) to 5 ([normal] active movement). A motor level responder was defined as a subject with improvement by ≥2 motor levels on either side of the body (i.e., baseline level C4 changed to C6, C7, C8 on the left; or baseline level C5 changed to C7, C8 on the right).|At 6 months post-treatment|"The Overall Number of Participants Analyzed included all randomized subjects who received study drug. As per the amended protocol, the 3 mg arm was no longer planned to be assessed for any primary or secondary outcome measure."|||percentage of participants|||Number
2559961|NCT02669914|Secondary|Overall Disease Control Rate of Extracranial Disease|"Defined as the percentage of patients who achieve a complete response, partial response, or stable disease based on assessment of systemic lesions~Complete response: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters~Stable disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study"|Completion of treatment (estimated to be 6 months)|Two participants were not evaluable in Cohort A as the extracranial response per RECIST was not done. There were not any participants enrolled in Cohort B or Cohort C.|||Participants|||Count of Participants
2559962|NCT02669914|Secondary|Overall Response Rate of Extracranial Disease|"Defined as the percentage of patients who achieve a complete response or partial response based on assessment of systemic lesions~Complete response: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters"|Completion of treatment (estimated to be 6 months)|Two participants were not evaluable in Cohort A as the extracranial response per RECIST was not done. There were not any participants enrolled in Cohort B or Cohort C.|||Participants|||Count of Participants
2559963|NCT02669914|Secondary|Overall Disease Control Rate of Intracranial Disease|"Defined as the percentage of patients who achieve a complete response, partial response, or stable disease based on assessment of brain lesions~CR: Requires: complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; No new lesions; stable or improved nonenhancing (T2/FLAIR) lesions.; off corticosteroids (or on physiologic replacement doses only) and stable or improved clinically.~PR: Requires:• ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks. • No progression of nonmeasurable disease. • Stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; the corticosteroid dose at the time of the scan evaluation should be no greater than the dose at time of baseline scan. • Stable or improved clinically"|Completion of treatment (estimated to be 6 months)|There were not any participants enrolled in Cohort B or Cohort C.|||Participants|||Count of Participants
2559964|NCT02669914|Secondary|Safety of MEDI4736 in Advanced Solid Epithelial-derived Tumor Patients With Brain Metastases as Measured by Number of Participants With Treatment-emergent Adverse Events|-The severity of AEs will be graded by the investigator according to the CTCAE, Version 4.03|30 days after completion of treatment (estimated to be 7 months)|There were not any participants enrolled in Cohort B or Cohort C.|||Participants|||Count of Participants
2559965|NCT02669914|Primary|Overall Response Rate of Intracranial Disease|"-% of subjects who achieve a complete response (CR) or partial response (CR) based on assessment of brain lesions~CR: Requires: complete disappearance of all enhancing measurable and nonmeasurable disease sustained for at least 4 weeks; No new lesions; stable or improved nonenhancing (T2/FLAIR) lesions.; off corticosteroids (or on physiologic replacement doses only) and stable or improved clinically.~PR: Requires:• ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks. • No progression of nonmeasurable disease. • Stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; the corticosteroid dose at the time of the scan evaluation should be no greater than the dose at time of baseline scan. • Stable or improved clinically"|Completion of treatment (estimated to be 6 months)|There were not any participants enrolled in Cohort B or Cohort C.|||Participants|||Count of Participants
2559966|NCT02669862|Secondary|PWA Responder|The percentage of participants who were responders with the target wart judged to be clear (PWA = 0) at Visit 10.|Day 57|PP population = participants completing protocol to visit 10|||percentage of responders|||Number
2559967|NCT02669862|Secondary|Durability of Response - Percentage of Participants That Were Clear at Visit 10 That Are Still Clear at Visit 13|Percentage of subjects whose target wart was clear at Visit 10 and who remained clear at Visit 13 for active treatment groups|visit 10 to visit 13|Only the number of participants clear at visit 10 are compared to the number of participants clear at visit 13 to get the percentage clear for active treatment groups only.|||percentage participants||95% Confidence Interval|Number
2559968|NCT02669862|Primary|Efficacy Based on Mean Change in Physician Wart Assessment Over Time|The primary effectiveness will consist of the mean change from Visit 2 to Visit 10 in Physician Wart Assessment (PWA) performed using Analysis of Covariance (ANCOVA) with Visit 2 PWA as the covariate. Physician Wart Analysis is a measurement scale from 0 to 3 that evaluates the wart with 0 being clear and 3 being clinically diagnosable wart that is raised, with an obviously rough surface.|57 Days|Number of participants analyzed is the number of participants completing the protocol through visit 10.|||units on a scale||Standard Deviation|Mean
2559969|NCT02669849|Secondary|Area Under Plasma Concentration Time Curve (AUC) of VX-210||up to 53 hours post-treatment|Pharmacokinetic analysis set included all participants for which PK data was collected. As per the amended protocol, the 3 mg arm was no longer planned to be assessed for any primary or secondary outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2559970|NCT02669849|Secondary|Maximum Observed Plasma Concentration (Cmax) of VX-210||up to 53 hours post-treatment|Pharmacokinetic analysis set included all participants for which PK data was collected. As per the amended protocol, the 3 mg arm was no longer planned to be assessed for any primary or secondary outcome measure.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2559971|NCT02669849|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-210||up to 53 hours post-treatment|Pharmacokinetic analysis set included all participants for which PK data was collected. As per the amended protocol, the 3 mg arm was no longer planned to be assessed for any primary or secondary outcome measure.|||hours (h)||Full Range|Median
2560001|NCT02669615|Primary|AUC0-t (Pharmacokinetics)|Area under the plasma concentration-time curve to the last measurable time point (AUC0-t) calculated by the trapezoidal rule. The area under the concentration-time curve (AUC) is calculated to determine the total drug exposure over a period of time.|Day -2||||ng*min/ml||Full Range|Median
2559973|NCT02669849|Secondary|Percentage of American Spinal Injury Association Impairment Scale (AIS) Grade Responders|AIS ranks impairment according to body-wide motor/sensory results: Grade A: Complete (no sensory or motor function is preserved in the sacral segments S4 to 5); Grade B: Sensory Incomplete (sensory but not motor function is preserved below the neurological level and includes the sacral segments S4 to 5); Grade C: Motor Incomplete (motor function is preserved at the most caudal sacral segments); Grade D: Motor Incomplete (motor incomplete status as defined above, with at least half or more of key muscle functions below the single neurological level of injury having a muscle grade >=3; Grade E: Normal (sensation and motor function as tested are graded as normal in all segments). An AIS responder was defined as a subject with improvement by ≥2 AIS grades (i.e., baseline AIS Grade A changed to Grade C, D, or E; baseline AIS Grade B changed to D or E at 6 months after treatment).|At 6 months post-treatment|"The Overall Number of Participants Analyzed included all randomized subjects who received study drug. As per the amended protocol, the 3 mg arm was no longer planned to be assessed for any primary or secondary outcome measure."|||percentage of participants|||Number
2559974|NCT02669849|Secondary|Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) Quantitative Prehension Score|GRASSP measures participant's ability to perform specific functional tasks with the arms, hands, and fingers. GRASSP quantitative prehension score ranges from 0-60, where a higher score indicates a better performance.|At 6 months post-treatment|"The Overall Number of Participants Analyzed included all randomized subjects who received study drug. As per the amended protocol, the 3 mg arm was no longer planned to be assessed for any primary or secondary outcome measure."|||units on a scale||Standard Deviation|Mean
2559975|NCT02669849|Secondary|Capabilities of Upper Extremity Test (CUE-T) Score|CUE-T measures a participant's ability to perform specific functional movements/tasks with the arms and hands (for example: grasping a pencil, pushing or lifting a weight). CUE-T score ranges from 0-128, where a higher score indicates an improvement in participant's ability.|At 6 months post-treatment|"The Overall Number of Participants Analyzed included all randomized subjects who received study drug. As per the amended protocol, the 3 mg arm was no longer planned to be assessed for any primary or secondary outcome measure."|||units on a scale||Standard Deviation|Mean
2559976|NCT02669849|Secondary|Spinal Cord Independence Measure (SCIM) III Self-Care Subscore|SCIM self-care subscore measures self-care abilities (feeding, dressing, grooming, bathing), respiration and sphincter management and mobility. The score ranges from 0-20, where a higher score represents a better outcome.|At 6 months post-treatment|"The Overall Number of Participants Analyzed included all randomized subjects who received study drug. As per the amended protocol, the 3 mg arm was no longer planned to be assessed for any primary or secondary outcome measure."|||units on a scale||Standard Deviation|Mean
2559977|NCT02669849|Primary|Change in Upper Extremity Motor Score (UEMS)|UEMS focuses selectively on the hand and arm control most relevant to individuals with a cervical spinal cord injury. UEMS ranges from 0 to 50, where a higher score indicates a better movement of hand and arm.|From baseline at 6 months post-treatment|"The Overall Number of Participants Analyzed included all randomized subjects who received study drug. As per the amended protocol, the 3 mg arm was no longer planned to be assessed for any primary or secondary outcome measure."|||units on a scale||Standard Deviation|Mean
2559978|NCT02669784|Primary|CTA Vessel Opacification Grading 2|"5 Point Grading Scale was used to determine CTA Vessel Opacification by a second Board Certified Radiologist.~Poor opacification with no difference in attenuation of the lumen compared to the wall of the vessel. Non diagnostic.~Decreased opacification. Little to no difference in attenuation between the lumen and the wall. Non diagnostic.~Moderate opacification of the lumen of the vessel. Diagnostic~Good opacification of the lumen of the vessel.~Excellent opacification of the lumen of the vessel with distinct difference in attenuation of the wall and lumen of the vessel."|30 days||||score on a scale||Full Range|Mean
2559979|NCT02669784|Primary|CTA Vessel Opacification Grading 1|"5 Point Grading Scale was used to determine CTA Vessel Opacification by a Board Certified Radiologist.~Poor opacification with no difference in attenuation of the lumen compared to the wall of the vessel. Non diagnostic.~Decreased opacification. Little to no difference in attenuation between the lumen and the wall. Non diagnostic.~Moderate opacification of the lumen of the vessel. Diagnostic study.~Good opacification of the lumen of the vessel.~Excellent opacification of the lumen of the vessel with distinct difference in attenuation of the wall and lumen of the vessel."|30 days||||score on a scale||Full Range|Mean
2559980|NCT02669784|Primary|Left Common Femoral Artery Measurement|Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the right common femoral artery.|30 days|All participants in the Contrast (Omnipaque) Low dose (40mL) underwent only a CTA of the chest or abdomen which is incapable of measuring the Left common femoral artery|||Hounsfield units||Full Range|Mean
2559981|NCT02669784|Primary|Right Common Femoral Artery Measurement|Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the right common femoral artery.|30 days|All participants in the Contrast (Omnipaque) Low dose (40mL) underwent only a CTA of the chest or abdomen which is incapable of measuring the right common femoral artery.|||Hounsfield units||Full Range|Mean
2559982|NCT02669784|Primary|Burfication Measurement|Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the distal abdominal aorta prior to the bifurcation.|30 days|Burfication measurements were taken from the following scans: Abdomen, Abdomen & Pelvis, and Chest, Abdomen, & Pelvis.|||Hounsfield units||Full Range|Mean
2559983|NCT02669784|Primary|Celiac Measurement|Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the proximal abdominal aorta at the level of the celiac axis.|30 days|Celiac Measurement was assessed for all scans: Chest, Abdomen, Abdomen & Pelvis, and Chest, Abdomen, & Pelvis.|||Hounsfield units||Full Range|Mean
2559984|NCT02669784|Primary|Descending Thoracic Aorta Measurement|Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the distal abdominal aorta prior to the bifurcation.|30 days|Descending Thoracic Aorta Measurement was assessed for the following scans: Chest, and Chest, Abdomen, & Pelvis|||Hounsfield units||Full Range|Mean
2559988|NCT02669667|Secondary|Serum Concentrations of MEDI9314|Baseline indicates the last assessment prior to first dose. For this study, the lower limit of quantification (LLOQ) for MEDI9314 serum concentrations were 19.53 μg/mL. Where serum concentrations were below this value, a serum concentration of 9.770 μg/mL was imputed.|Baseline (Day 1 [predose]) and Day 240|PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The “Number Analyzed” denotes the number of participants evaluated for this outcome measure.|||μg/mL||Standard Deviation|Mean
2559989|NCT02669667|Secondary|Terminal Phase Elimination Half-life (t1/2) of MEDI9314|Terminal phase elimination half-life of MEDI9314|Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240|The PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The “Number Analyzed” denotes the number of participants evaluated for this outcome measure.|||Day||Standard Deviation|Mean
2559990|NCT02669667|Secondary|Time to Maximum Observed Serum Drug Concentration (Tmax) of MEDI9314|The time to maximum observed serum drug concentration of MEDI9314.|Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240|PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters.|||Day||Full Range|Median
2559991|NCT02669667|Secondary|Maximum Observed Serum Drug Concentration (Cmax) of MEDI9314|The maximum observed serum drug concentration of MEDI9314.|Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240|PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters.|||µg/mL||Standard Deviation|Mean
2559992|NCT02669667|Secondary|Area Under the Serum Drug Concentration Versus Time Curve, to Last Quantifiable Time Point (AUClast)|The area under the serum drug concentration versus time curve, to last quantifiable time point of MEDI9314.|Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240|The PK population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The “Number Analyzed” denotes the number of participants evaluated for this outcome measure.|||μg*d/mL||Standard Deviation|Mean
2559993|NCT02669667|Secondary|Area Under the Serum Drug Concentration Versus Time Curves From Zero to Infinity (AUC 0-inf) of MEDI9314|The area under the serum drug concentration versus time curves from zero to infinity of MEDI9314.|Day 1 (predose); at the end of infusion (for IV groups); 24, 48, 72, and 96 hours post dose; and on Days 8, 10, 15, 22, 29, 36, 43, 57, 85, 113, 141, 197, and 240|Pharmacokinetic (PK) population included all participants in the as-treated population who received MEDI9314 and who have detectable post-dosing MEDI9314 serum concentrations for accurate estimation of PK parameters. The “Number Analyzed” denotes the number of participants evaluated for this outcome measure.|||µg*d/mL||Standard Deviation|Mean
2559994|NCT02669667|Primary|Number of Participants With TEAEs Related to Injection Site Reactions|Adverse events of special interest observed in participants with clinically significant injection site reaction were assessed.|From the start of study drug administration upto Day 240|As-treated population included participants who received any study drug and summarized according to the treatment they actually received.|||Participants|||Count of Participants
2559995|NCT02669667|Primary|Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs|An abnormal laboratory finding which required an action or medical intervention by the investigator, or a finding judged by the investigator as medically significant should be reported as an adverse event. Laboratory evaluation (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.|From the start of study drug administration upto Day 240|As-treated population included participants who received any study drug and summarized according to the treatment they actually received.|||Participants|||Count of Participants
2559996|NCT02669667|Primary|Number of Participants With Physical Examination Abnormalities Reported as TEAEs|Adverse events observed in participants with clinically significant physical abnormalities were assessed.|From the start of study drug administration upto Day 240|As-treated population included participants who received any study drug and summarized according to the treatment they actually received.|||Participants|||Count of Participants
2559997|NCT02669667|Primary|Number of Participants With Vital Signs Abnormalities Reported as TEAEs|Vital sign parameters included blood pressure, heart rate, and temperature. TEAEs observed in participants with clinically significant vital signs abnormalities were reported.|From the start of study drug administration upto Day 240|As-treated population included participants who received any study drug and summarized according to the treatment they actually received.|||Participants|||Count of Participants
2559998|NCT02669667|Primary|Number of Participants With Electrocardiogram Abnormalities Reported as TEAEs|TEAEs observed in participants with clinically significant ECG abnormalities were reported.|From the start of study drug administration upto Day 240|As-treated population included participants who received any study drug and summarized according to the treatment they actually received.|||Participants|||Count of Participants
2559999|NCT02669667|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any AE that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug and up to Day 240.|From the start of study drug administration upto Day 240|As-treated population included participants who received any study drug and summarized according to the treatment they actually received.|||Participants|||Count of Participants
2560003|NCT02669433|Secondary|Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24|To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment. CIBIC+ is recorded on a 7-point scale with a score of 4 indicating no change, scores above 4 indicating worsening, and scores below 4 indicating improvement.|Change from Baseline at 24 weeks|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2560004|NCT02669433|Secondary|Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24|The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.|Change from Baseline at 24 weeks|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2560005|NCT02669433|Primary|Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24|The primary endpoint was to assess the effects of intepirdine versus placebo on the UPDRS Part III after 24 weeks of treatment. UPDRS Part III scores range from 0 to 108, with higher scores indicating worse outcome.|Change from Baseline at 24 weeks|UPDRS Primary Population|||units on a scale||Standard Error|Least Squares Mean
2560006|NCT02669407|Secondary|Change in Clinical Symptoms, as Measured by 6 Minute Walk Test|The 6 Minute Walk Test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.|Baseline, 90 minutes, 24 hours|Participants who completed the study.|||meters||Standard Deviation|Mean
2560007|NCT02669407|Secondary|Dyspnea as Measured on Likert Scale|The scale ranges from -3 (markedly worse) to 3 (markedly improved). 0 = no change.|15, 30, 45, 60, 75, 90 minutes; 24 hours|Participants who completed the study.|||Participants|||Count of Participants
2560008|NCT02669407|Secondary|Change in Creatinine Level|Creatinine measurements are used to evaluate renal function. Higher creatinine levels indicate less stability.|Baseline; 90 minutes|Participants who completed the study.|||mg/dL||Inter-Quartile Range|Median
2560009|NCT02669407|Secondary|Change in Blood Urea Nitrogen (BUN)|BUN represents the major nitrogen excretion pathway and is used to evaluate renal function. Higher BUN levels indicate less stability.|Baseline; 90 minutes|Participants who completed the study.|||mg/dL||Inter-Quartile Range|Median
2560010|NCT02669407|Secondary|Urine Output Measured in ml Over 3 Hours||Baseline, post-procedure (0-3 hours)|Participants who completed the study.|||ml over 3 hours||Standard Deviation|Mean
2560011|NCT02669407|Secondary|N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Level|NT-proBNP level is elevated in heart failure and reflects its severity. A higher value indicates less stability.|Baseline; 90 minutes|Participants who completed the study.|||pg/dL||Inter-Quartile Range|Median
2560012|NCT02669407|Secondary|Left Ventricular Diameter||Baseline, 30 mins|Participants who completed the study|||cm||Standard Deviation|Median
2560013|NCT02669407|Secondary|Right Ventricular Diameter||Baseline, 30 mins|Data not collected||||||
2560014|NCT02669407|Secondary|Pulmonary Artery Systolic Pressure||Baseline, 30 minutes||||mmHg||Standard Deviation|Mean
2560015|NCT02669407|Secondary|Ejection Fraction (LVEF)||Baseline, 90 minutes|Participants who completed the study|||percentage of ejected blood per contract||Standard Deviation|Mean
2560016|NCT02669407|Secondary|Cardiac Index||baseline, 30 minutes|Participants who completed the study.|||L/min/m^2||Standard Deviation|Mean
2560017|NCT02669407|Primary|Pulmonary Capillary Wedge Pressure||baseline, 30 minutes|Participants who completed the study.|||mmHg||Standard Deviation|Mean
2560018|NCT02669407|Primary|Pulmonary Arterial Mean Pressure||baseline, 30 minutes|Participants who completed the study.|||mmHg||Standard Deviation|Mean
2560019|NCT02669407|Primary|Central Venous Pressure||Baseline, 90 minutes|Participants who completed the study|||mmHg||Standard Deviation|Mean
2560020|NCT02669264|Secondary|Number of Participants With Anti-drug Antibody Response (ADA) Against ADCT-402|Blood serum samples were collected and analysed to determine the presence or absence of ADA.|Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2||||Participants|||Count of Participants
2560021|NCT02669264|Secondary|Apparent Volume of Distribution (Vd Beta) for ADCT-402 Administered Every Week (QW)|Vd beta for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.|Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||liters||Standard Deviation|Mean
2560022|NCT02669264|Secondary|Apparent Volume of Distribution (Vd Beta) for ADCT-402 Administered Every 3 Weeks (Q3W)|Vd beta for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.|Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||liters||Standard Deviation|Mean
2560023|NCT02669264|Secondary|Apparent Clearance at Steady State for ADCT-402 Administered Every Week (QW)|Apparent clearance for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.|Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||L/day||Standard Deviation|Mean
2560024|NCT02669264|Secondary|Apparent Clearance at Steady State for ADCT-402 Administered Every 3 Weeks (Q3W)|Apparent clearance for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.|Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||L/day||Standard Deviation|Mean
2560025|NCT02669264|Secondary|Apparent Terminal Phase Elimination Half-life (T1/2) for ADCT-402 Administered Every Week (QW)|T1/2 for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.|Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||days||Standard Deviation|Mean
2560026|NCT02669264|Secondary|Apparent Terminal Phase Elimination Half-life (T1/2) for ADCT-402 Administered Every 3 Weeks (Q3W)|T1/2 for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.|Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||days||Standard Deviation|Mean
2560027|NCT02669264|Secondary|Terminal Elimination Phase Rate Constant for ADCT-402||Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|This analysis was planned, but data was not collected as the study was terminated prematurely.||||||
2560028|NCT02669264|Secondary|Mean Residence Time for ADCT-402||Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|This analysis was planned, but data was not collected as the study was terminated prematurely.||||||
2560029|NCT02669264|Secondary|Volume of Distribution at Steady State for ADCT-402||Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|This analysis was planned, but data was not collected as the study was terminated prematurely.||||||
2560030|NCT02669264|Secondary|Accumulation Index (AI) for ADCT-402 Administered Weekly (QW)|AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort. AI is the ratio of AUC 0-24 after multiple doses versus a single dose. It is the increase in drug plasma concentration after multiple dosing until a steady state is reached.|Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||ratio||Standard Deviation|Mean
2560031|NCT02669264|Secondary|Accumulation Index (AI) for ADCT-402 Administered Every 3 Weeks (Q3W)|AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts. AI is the ratio of AUC 0-24 after multiple doses versus a single dose. It is the increase in drug plasma concentration after multiple dosing until a steady state is reached.|Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||ratio||Standard Deviation|Mean
2560032|NCT02669264|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) for ADCT-402 Administered Every Week (QW)|AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.|Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||day*ug/L||Standard Deviation|Mean
2560033|NCT02669264|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUC0-tau) for ADCT-402 Administered Every 3 Weeks (Q3W)|AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.|Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||day*ug/L||Standard Deviation|Mean
2560034|NCT02669264|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for ADCT-402 Administered Weekly (QW)|AUC∞ for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.|Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||day*ug/L||Standard Deviation|Mean
2560035|NCT02669264|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC∞) for ADCT-402 Administered Every 3 Weeks (Q3W)|AUC∞ for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.|Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||day*ug/L||Standard Deviation|Mean
2560036|NCT02669264|Secondary|Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every Week (QW)|AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.|Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||day*ug/L||Standard Deviation|Mean
2560136|NCT02668198|Primary|Positive Recurrent Adenomas Using White Light Imaging|The number of positive diagnoses using white light optical imaging only.|approximately 6 to 12 months post endoscopic mucosal resection||||adenomas with positive diagnoses|||Number
2561398|NCT02650921|Secondary|GAIS by Treating Investigator|Global Aesthetic Improvement Scale|20 weeks|ITT|||Participants|||Count of Participants
2560037|NCT02669264|Secondary|Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402 Administered Every 3 Weeks (Q3W)|AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.|Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||day*ug/L||Standard Deviation|Mean
2560038|NCT02669264|Secondary|Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every Week (QW)|Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.|Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||days||Standard Deviation|Mean
2560039|NCT02669264|Secondary|Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402 Administered Every 3 Weeks (Q3W)|Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.|Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||days||Standard Deviation|Mean
2560040|NCT02669264|Secondary|Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every Week (QW)|Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the QW cohort.|Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||µg/L||Standard Deviation|Mean
2560041|NCT02669264|Secondary|Maximum Observed Serum Concentration (Cmax) for ADCT-402 Administered Every 3 Weeks (Q3W)|Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for the Q3W cohorts.|Day 1 (before infusion, end of infusion, and 1, 3 and 6 hours after infusion) and Days 2, 3, 5, 8 and 15 for Cycles 1 and 2|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||µg/L||Standard Deviation|Mean
2560042|NCT02669264|Secondary|Progression-free Survival|Progression-free survival is defined among the efficacy population as the time from first dose of study drug until the first date of either disease progression or death due to any cause.|From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug|This analysis was planned, but data was not collected as the study was terminated prematurely.||||||
2560043|NCT02669264|Secondary|Overall Survival|Overall survival is defined as the time from the first dose of study drug treatment until the date of death due to any cause.|From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug|This analysis was planned, but data was not collected as the study was terminated prematurely.||||||
2560044|NCT02669264|Secondary|Duration of Response|"Duration of response is defined among responders (complete response [CR], complete response with incomplete blood count recovery [Cri], and partial response [PR]) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause.~Disease progression is defined as:~For participants with CR or CRi, the first date of reappearance of blast cells in bone marrow and/or peripheral blood to a level ≥5%, or development of extramedullary disease.~For participants with PR, the first date of an increase in blast cells in bone marrow and/or peripheral blood such that the patient does not continue to meet the criteria for PR."|From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug|This analysis was planned, but data was not collected as the study was terminated prematurely.||||||
2560045|NCT02669264|Secondary|Overall Response Rate (ORR)|"ORR is defined as the number of participants with a best overall response of complete response (CR), complete response with incomplete blood count recovery (Cri) or partial response (PR) at the time each participant discontinues treatment with ADCT-402.~CR is defined as achieving each of the following:~Bone marrow differential showing ≤5% blast cells.~Absolute neutrophil count (ANC) ≥1.0 x 10^9/L and platelet count ≥100 x 10^9/L.~Absence of extramedullary disease.~Participant is independent of red blood cell transfusions.~Cri is defined as achieving all CR criteria except that values for ANC may be <1.0 x 10^9/L and/or values for platelets may be <100 x 10^9/L.~PR is defined as achieving each of the following:~ANC ≥1.0 x 10^9/L and platelet count ≥100 x 10^9/L.~Bone marrow differential showing a ≥50% decrease from baseline in the percentage of bone marrow blast cells to a level >5% and ≤25%, or bone marrow differential showing <5% blast cells."|From 6 days prior to Day 1 of Cycle 3 and 5, and at each subsequent cycle, until discontinuation, assessed up to 12 months after last dose of study drug|This analysis was planned, but data was not collected as the study was terminated prematurely.||||||
2560046|NCT02669264|Primary|Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to study drug. A treatment-emergent AE (TEAE) is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug. An SAE is defined as any event that results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)||||Participants|||Count of Participants
2560281|NCT02666222|Primary|Incidence of Serious Adverse Device Events (SADEs) and Device Failures and Replacements at Each Follow-up.|ENDPOINT #3: The analysis of the incidence of SADEs and device failures and replacements at each follow-up.|SADEs, PAS phase through Year 5 of Follow Up|Cumulative through 5-Year Follow-up|||participants|||Number
2560047|NCT02669264|Primary|Number of Participants Reporting at Least One Treatment Emergent Adverse Event (TEAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participants enrolled into this study regardless of its causal relationship to study drug. A TEAE is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug.|From first dose of study drug up to 12 weeks after last dose (up to 39 weeks)|Safety analysis set|||Participants|||Count of Participants
2560048|NCT02669264|Primary|Recommended Dose of ADCT-402 for Part 2|The recommended dose was to be established by the dose escalation steering committee and based on safety findings during part 1 of the study.|Day 1 to End of Cycle 1 (3 weeks)|This analysis was planned, but data was not collected as the study was terminated prematurely.||||||
2560049|NCT02669264|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|"A DLT is defined as any of the following events, except those that are clearly due to underlying disease or extraneous causes:~A hematologic DLT is defined as:~- Grade 3 or higher event of neutropenia or thrombocytopenia, or a Grade 4 anemia, with a hypocellular bone marrow lasting for 6 weeks or more after the start of a cycle, in the absence of residual leukemia (i.e., with <5% blasts). In case of a normocellular bone marrow with <5% blasts, 8 weeks with ≥Grade 3 pancytopenia will be considered a DLT.~A non-hematologic DLT is defined as:~Grade 4 tumor lysis syndrome (Grade 3 TLS will not constitute DLT unless it leads to irreversible end-organ damage).~Grade 3 or higher AE (including nausea, vomiting, diarrhea, and electrolyte imbalances lasting more than 48 hours despite optimal therapy; excluding all grades of alopecia).~CTCAE Grade 3 or higher hypersensitivity reaction (regardless of premedication).~CTCAE Grade 3 or higher skin ulceration."|Day 1 to End of Cycle 1 (3 weeks)|Safety analysis set|||Participants|||Count of Participants
2560050|NCT02669095|Primary|Overall Comfort|Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. CLUE Comfort was assessed at 1-, 2-, 3 and 4- week Follow-up evaluations. The average CLUE comfort score for each lens was reported for each visit.|Up to 4 Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Units on a scale||Standard Deviation|Mean
2560051|NCT02669095|Primary|Acceptable Lens Fitting|Lens fit was assessed and recorded for each subject and eye at post lens fitting, 1-, 2-, 3- and 4- week follow-up evaluations. Lens fit was a binary response acceptable and unacceptable lens fit. The proportion of eyes with acceptable lens fitting at post lens fit and across all four follow-ups was combined and reported.|Up to 4 Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Proportion of eyes|Subject Eyes||Number
2560052|NCT02669082|Secondary|Change From Baseline in Actigraphy-Measured Daytime Activity Level, as Evaluated by the Number of Footsteps, at the End of the Treatment Period|Daytime activity level, as evaluated by the number of footsteps, were assessed by actigraphy, a non-intrusive tool that measures an individual's movement. Mean value from the past 7 days at each timepoint was evaluated. A positive change from Baseline indicates improvement.|Baseline and the end of the Treatment Period (up to Week 8)|FAS was defined as all participants given at least 1 dose of study drug.|||steps||Standard Deviation|Mean
2560053|NCT02669082|Secondary|Change From Baseline in Diary-Measured Number of Nocturnal Awakenings at the End of the Treatment Period|The number of nocturnal awakenings were recorded by the participant in a diary. Mean value from the past 7 days at each timepoint was evaluated. A negative change from Baseline indicates improvement.|Baseline and the end of the Treatment Period (up to Week 8)|FAS was defined as all participants given at least 1 dose of study drug.|||nocturnal awakenings||Standard Deviation|Mean
2560054|NCT02669082|Secondary|Change From Baseline in Diary-Measured Total Nocturnal Sleep Time at the End of the Treatment Period|Total nocturnal sleep time by diary was calculated as total time in bed (awaking hour - bedtime hour) from which sleep latency was subtracted. Mean value from the past 7 days at each timepoint was evaluated. A positive change from Baseline indicates improvement.|Baseline and the end of the Treatment Period (up to Week 8)|FAS was defined as all participants given at least 1 dose of study drug.|||minutes||Standard Deviation|Mean
2560055|NCT02669082|Secondary|Change From Baseline in Actigraphy-Measured Sleep Efficiency at the End of the Treatment Period|Sleep efficiency was defined as percentage of sleep in the period potentially filled by sleep-ratio of total sleep time to time in bed calculated as [(Total sleep time/total time in bed) * 100]. Sleep efficiency was assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. Mean value from the past 7 days at each timepoint was evaluated. A positive change from Baseline indicates improvement.|Baseline and the end of the Treatment Period (up to Week 8)|FAS was defined as all participants given at least 1 dose of study drug.|||percentage of sleep||Standard Deviation|Mean
2560056|NCT02669082|Secondary|Change From Baseline in Actigraphy-Measured Number of Nocturnal Awakenings at the End of the Treatment Period|The number of nocturnal awakenings were assessed by actigraphy which is a non-intrusive tool that measures an individual's movement during sleep. Mean value from the past 7 days at each time point was evaluated. A positive change from Baseline indicates a worsening.|Baseline and the end of the Treatment Period (up to Week 8)|FAS was defined as all participants given at least 1 dose of study drug.|||nocturnal awakenings||Standard Deviation|Mean
2560057|NCT02669082|Secondary|Change From Baseline in Actigraphy-Measured Nocturnal Wake Time at the End of the Treatment Period|Nocturnal wake time is the total time that is scored between nocturnal sleep onset and final wake-up. Nocturnal wake time was assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. Mean value from the past 7 days at each timepoint was evaluated. A positive change from Baseline indicates a worsening.|Baseline and the end of the Treatment Period (up to Week 8)|FAS was defined as all participants given at least 1 dose of study drug.|||minutes||Standard Deviation|Mean
2560137|NCT02667912|Secondary|Changes of Nighttime Mean Diastolic BP||From baseline to 12 months|ITT analysis by Last Observation Carried Forward (LOCF) method in the subjects with the available data. (6 month data were used in 4 late (>6 months) dropouts and also in 1 patient without 12 month’ ABPM, 1 month data were used in 2 early (<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis)|||mmHg||Standard Deviation|Mean
2560058|NCT02669082|Secondary|Change From Baseline in Actigraphy-Measured Total Nocturnal Sleep Time at the End of the Treatment Period|Total nocturnal sleep time was assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. Total nocturnal sleep time by actigraphy was total time in bed from which sleep latency, nocturnal wake time, and the time from waking up to leaving the bed were subtracted. Mean value from the past 7 days at each timepoint was evaluated. A positive change from Baseline indicates improvement.|Baseline and the end of the Treatment Period (up to Week 8)|FAS was defined as all participants given at least 1 dose of study drug.|||minutes||Standard Deviation|Mean
2560059|NCT02669082|Secondary|Change From Baseline in Diary-Measured Sleep Latency at the End of the Treatment Period|"Sleep latency was defined as time period measured from lights out, or bedtime, to the beginning of sleep. Sleep latency was recorded by the participant in a diary. Mean value from the past 7 days at each timepoint was evaluated. A negative change from Baseline indicates improvement."|Baseline and the end of the Treatment Period (up to Week 8)|FAS was defined as all participants given at least 1 dose of study drug.|||minutes||Standard Deviation|Mean
2560060|NCT02669082|Primary|Change From Baseline in Actigraphy-Measured Sleep Latency at the End of the Treatment Period|"Sleep latency was defined as time period measured from lights out, or bedtime, to the beginning of sleep. Sleep latency was assessed by actigraphy, a non-intrusive tool that measures an individual's movement during sleep. Mean value from the past 7 days was evaluated. A negative change from Baseline indicates improvement."|Baseline and the end of the Treatment Period (up to Week 8)|Full Analysis Set (FAS) was defined as all participants given at least 1 dose of study drug.|||minutes||Standard Deviation|Mean
2560061|NCT02669043|Primary|Hamilton Depression Rating Scale (HDRS, HAM-D)|Continuous score of depression symptoms. The higher the score, the more severe the depression. HAMD scores range from 0 to 81.|48 hours|Patients who completed the study. Outcome measure was at 48 hours.|||units on a scale||Full Range|Mean
2560062|NCT02669017|Secondary|Number of Participants With Anti-drug Antibody Response (ADA) Against ADCT-402|"Blood serum samples were collected and analysed to determine the presence or absence of ADA.~ADA is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4."|Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)|All participants who were tested for ADA.|||Participants|||Count of Participants
2560063|NCT02669017|Secondary|Accumulation Index (AI) for ADCT-402|"AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199). AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1 (Q3W schedule: 3 week cycle length; Q6W schedule: 6 week cycle length). It is the increase in drug plasma concentration after multiple dosing until a steady state is reached.~Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol."|Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)|Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||ratio||Standard Deviation|Mean
2560064|NCT02669017|Secondary|Volume of Distribution at Steady State (Vss) for ADCT-402|"Vss for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).~Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol."|Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)|Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||liters||Standard Deviation|Mean
2560065|NCT02669017|Secondary|Apparent Clearance (CL) at Steady State for ADCT-402|"CL of Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).~Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol."|Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)|Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||liters/day||Standard Deviation|Mean
2560066|NCT02669017|Secondary|Terminal Half-life (Thalf) of ADCT-402|"Thalf of Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).~Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol."|Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)|Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||days||Full Range|Median
2560067|NCT02669017|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for ADCT-402|"AUCinf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).~Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol."|Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)|Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||day*ng/mL||Standard Deviation|Mean
2560138|NCT02667912|Secondary|Changes of Nighttime Mean Diastolic BP||From baseline to 6 months|PPS|||mmHg||Standard Deviation|Mean
2560143|NCT02667912|Secondary|Changes of Daytime Mean Systolic BP||From baseline to 12 months|ITT analysis by Last Observation Carried Forward (LOCF) method. (Six month data were used in 4 late (>6 months) dropouts and also in 1 patient without 12 month’ ABPM, 1 month data were used in 2 early (<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis)|||mmHg||Standard Deviation|Mean
2560068|NCT02669017|Secondary|Area Under the Serum Concentration-Time Curve From Time 0 to the End of the Dosing Interval (AUCtau) for ADCT-402|"AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).~Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol."|Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)|Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||day*ng/mL||Standard Deviation|Mean
2560069|NCT02669017|Secondary|Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-402|"AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).~Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol."|Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)|Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||day*ng/mL||Standard Deviation|Mean
2560070|NCT02669017|Secondary|Time to Reach the Maximum Serum Concentration (Tmax) for ADCT-402|"Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).~Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol."|Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)|Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||days||Full Range|Median
2560071|NCT02669017|Secondary|Maximum Observed Serum Concentration (Cmax) for ADCT-402|"Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199).~Results for Part 1 and Part 2 have been pooled for the same dosage and schedule, as specified in the protocol."|Q3W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (3 weeks cycle); Q6W schedule: Day 1 (pre-dose and 1 to 6 hours post-dose), and days 2, 3, 5, 8, 15 and 21 of Cycles 1 and 2 (6 week cycle)|Only participants with evaluable pharmacokinetic (PK) results were included in the analysis. Where data is not presented, the PK profiles were non-measurable or short-lived in duration; therefore, no analysis could be performed.|||ng/mL||Standard Deviation|Mean
2560072|NCT02669017|Secondary|Progression-free Survival (PFS)|"PFS is defined among the efficacy population as the time from first dose of study drug until either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification for response.~Disease progression is defined as progressive metabolic disease or one of the follow:~Target node progression.~An individual extranodal lesion must be abnormal with length >1.5cm and/or increase of length >50%.~New or clear progression of nonmeasured lesions.~Regrowth of previously resolved lesions or new nodes >1.5 cm in length.~New or recurrent bone marrow involvement.~PFS is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4."|Baseline to End of Study (a maximum of 18 months)|All participants who received at least one dose of study treatment with a valid baseline disease assessment and at least one valid post-baseline disease assessment. Results are pooled for all arms as specified in the protocol.|||months||95% Confidence Interval|Median
2560073|NCT02669017|Secondary|Overall Survival (OS)|"OS is defined as the time from the first dose of study drug treatment until the date of death due to any cause.~OS is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4."|Baseline to End of Study (a maximum of 18 months)|All participants who received at least one dose of study treatment with a valid baseline disease assessment and at least one valid post-baseline disease assessment. Results are pooled for all arms as specified in the protocol.|||months||95% Confidence Interval|Median
2560074|NCT02669017|Secondary|Duration of Response (DoR)|"DoR is defined among responders (complete response [CR] and partial response [PR]) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause. Tumor response was assessed using the 2014 Lugano Classification for response.~Disease progression is defined as progressive metabolic disease or one of the follow:~Target node progression.~An individual extranodal lesion must be abnormal with length >1.5cm and/or increase of length >50%.~New or clear progression of nonmeasured lesions.~Regrowth of previously resolved lesions or new nodes >1.5 cm in length.~New or recurrent bone marrow involvement.~DoR is presented overall for all participants who received ADCT-402, as specified in protocol section 7.4."|Baseline to End of Study (a maximum of 18 months)|All participants who received at least one dose of study treatment with a valid baseline disease assessment and at least one valid post-baseline disease assessment. Results are pooled for all arms as specified in the protocol.|||months||95% Confidence Interval|Median
2560075|NCT02669017|Secondary|Overall Response Rate (ORR)|"ORR was defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) at the time each participant discontinued treatment with ADCT-402, before the start of subsequent anticancer therapy or procedure. Tumor response was assessed using the 2014 Lugano Classification for response.~CR is defined as achieving either of the following:~Complete metabolic response.~Complete radiologic response (target node regress to <1.5 cm, no nonmeasured lesions, no organ enlargement, no new lesions and normal bone marrow morphology).~PR is defined as achieving either of the following:~Partial metabolic response (findings indicate residual disease).~Partial remission (>50% decrease in target measurable nodes, regression/ absence/ no increase of nonmeasured lesions, spleen regressed by >50% in length and no new lesions)."|Baseline to End of Study (a maximum of 18 months)|All participants who received at least one dose of study treatment with a valid baseline disease assessment and at least one valid post-baseline disease assessment.|||Participants|||Count of Participants
2560144|NCT02667912|Secondary|Changes of Daytime Systolic BP||From baseline to 6 months|PPS|||mmHg||Standard Deviation|Mean
2560145|NCT02667912|Secondary|Changes of Office Diastolic BP||From baseline to 12 months||||mmHg||Standard Deviation|Mean
2560076|NCT02669017|Primary|Number of Participants Reporting at Least One Treatment Emergent Serious Adverse Event (SAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant enrolled into this study regardless of its causal relationship to study drug. A treatment emergent AE (TEAE) is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug. An SAE is defined as any event that results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|Day 1 to End of Study (a maximum of 18 months)|All participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2560077|NCT02669017|Primary|Number of Participants Reporting at Least One Treatment Emergent Adverse Event (TEAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participants enrolled into this study regardless of its causal relationship to study drug. A TEAE is defined as any event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug.|Day 1 to End of Study (a maximum of 18 months)|All participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2560078|NCT02669017|Primary|Recommended Dose of ADCT-402 for Part 2|The recommended dose was established by the dose escalation steering committee and based on safety findings during Part 1 of the study.|Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)|All participants in Part 1 who completed at least one cycle of treatment.|||μg/kg|||Number
2560079|NCT02669017|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|"A DLT is defined as any of the following events, except those that are clearly due to underlying disease or extraneous causes:~A hematologic DLT is defined as:~CTCAE Grade 3 or 4 febrile neutropenia or neutropenic infection.~CTCAE Grade 4 neutropenia lasting >7 days.~CTCAE Grade 4 thrombocytopenia.~CTCAE Grade 3 thrombocytopenia with clinically significant bleeding, or Grade 3 thrombocytopenia requiring a platelet transfusion.~CTCAE Grade 4 anemia.~A non-hematologic DLT is defined as:~CTCAE Grade 4 tumor lysis syndrome (TLS). Grade 3 TLS will not constitute DLT unless it leads to irreversible end-organ damage.~CTCAE Grade 3 or higher AE (including nausea, vomiting, diarrhea, and electrolyte imbalances lasting more than 48 hours despite optimal therapy; excluding all grades of alopecia).~CTCAE Grade 3 or higher hypersensitivity reaction (regardless of premedication).~CTCAE Grade 2 or higher skin ulceration."|Q3W schedule: Day 1 to End of Cycle 1 (3 weeks); Q6W schedule: Day 1 to End of Cycle 1 (6 weeks)|All participants in Part 1 who completed at least one cycle of treatment.|||Participants|||Count of Participants
2560080|NCT02668952|Secondary|Serum Chloride at 48 Hours|Serum chloride measurement at 48 hours postoperatively|2 days||||mmol/L||Standard Deviation|Mean
2560081|NCT02668952|Secondary|Serum Creatinine Level at 48 Hours|Serum creatinine level 48 hours postoperatively|2 days||||mg/dL||Standard Deviation|Mean
2560082|NCT02668952|Secondary|Postoperative Arterial pH|Arterial pH, measured 24 hours after surgery|One day||||pH||Standard Deviation|Mean
2560083|NCT02668952|Secondary|Proportion of Patients With Need for Dialysis|Clinically-determined need for dialysis prior to discharge from hospital|One week||||percentage of patients|||Number
2560084|NCT02668952|Secondary|Serum Chloride Level at 24 Hours|Serum chloride ion measurement at 24 hours postoperatively|1 day||||mmol/L||Standard Deviation|Mean
2560085|NCT02668952|Secondary|Serum Creatinine Level at 24 Hours|Serum creatinine measurement at 24 hours|1 day||||mg/dL||Standard Deviation|Mean
2560086|NCT02668952|Primary|Change in [TIMP2]*[IGFBP7] Biomarker|The difference in the [TIMP2]*[IGFBP7] biomarker between the preoperative value and a repeated measurement at 24 hours postoperatively. Positive values represent increase; negative values represent decrease|Baseline and postoperatively at 24 hours||||(ng/mL)^2/1000||Standard Deviation|Mean
2560087|NCT02668822|Secondary|Change From Baseline in the Mean Pelvic Pain Score at Treatment Cycle 2|The mean pelvic pain score was to be calculated as the mean of the highest scores for pelvic pain observed within the 4-day cramping window of the screening or treatment cycle. The baseline mean pelvic pain score was to be defined as the mean value of the 2 mean pelvic pain scores of the 2 menstruations during the screening period. The change from baseline in mean pelvic pain score at Treatment Cycle 2 was to be presented.|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|The population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, the committee to determine cramping windows was not assembled, cramping windows were not determined & data could not be analyzed.||||||
2560088|NCT02668822|Secondary|Percentage of Participants With ≥3-point Reduction in Peak Pelvic Pain Score and a Decrease in Number of Ibuprofen Tablets Taken at Treatment Cycle 2, Compared to Baseline|Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The baseline peak pelvic pain score and number of ibuprofen tablets taken were to be defined as the mean value of the 2 peak pelvic pain scores and the mean value of the total number of ibuprofen tablets taken during the cramping window of each of the 2 menstruations during the screening period, respectively. The percentage of participants with a reduction in peak pelvic pain score of ≥3 points and a decrease in the use of ibuprofen at Treatment Cycle 2 as compared to baseline was to be presented.|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|The population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, the committee to determine cramping windows was not assembled, cramping windows were not determined & data could not be analyzed.||||||
2560139|NCT02667912|Secondary|Changes of Nighttime Mean Systolic BP||From baseline to 12 months|ITT analysis by Last Observation Carried Forward (LOCF) method in the subjects with the available data. (Six month data were used in 4 late (>6 months) dropouts and also in 1 patient without 12 month’ ABPM, 1 month data were used in 2 early (<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis)|||mmHg||Standard Deviation|Mean
2560140|NCT02667912|Secondary|Changes of Nighttime Mean Systolic BP||From baseline to 6 months|PPS|||mmHg||Standard Deviation|Mean
2560089|NCT02668822|Secondary|"Percentage of Participants With Pelvic Pain Score of 0 or 1 and no Use of Ibuprofen Tablets at Treatment Cycle 2"|"Participants were asked to rate their worst pain or cramps on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The percentage of participants with no or minimal pelvic pain (score of 0 or 1) and no use of ibuprofen at Treatment Cycle 2 was to be presented."|Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|The population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during Treatment Cycle 2. Due to termination, the committee to determine cramping windows was not assembled, cramping windows were not determined & data could not be analyzed.||||||
2560090|NCT02668822|Secondary|Change From Baseline in the Number of Days With no Impact on Items of Physical, Work/School and Social/Leisure Activities at Treatment Cycle 2|Participants were asked to indicate how much pain or cramps limited their physical, work/school and social/leisure activities and over the previous 24 hours. The level of negative impact of dysmenorrhea on daily life was scored on a 5-point scale (0=Not at all to 4=Extremely impacted). For each of the 3 impact items, the baseline score was to be defined as the mean value obtained from the 2 menstruations during the screening period. The change from baseline to Treatment Cycle 2 in the number of days during the cramping window with no impact of dysmenorrhea (score = 0) on each of the following items was to be presented: work/school, physical activities and leisure/social activities.|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|The population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, the committee to determine cramping windows was not assembled, cramping windows were not determined & data could not be analyzed.||||||
2560091|NCT02668822|Secondary|Change From Baseline in Peak Pelvic Pain Score at Treatment Cycle 2|Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps). The peak pelvic pain score was to be calculated as the highest (daily) pelvic pain score observed within the 4-day cramping window of the cycle. The baseline peak pelvic pain score was to be defined as the mean value of the 2 peak pelvic pain scores during the cramping window of each of the 2 menstruations during the screening period. The change from baseline in peak pelvic pain score at Treatment Cycle 2 was to be presented.|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|The population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, the committee to determine cramping windows was not assembled, cramping windows were not determined & data could not be analyzed.||||||
2560092|NCT02668822|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who discontinued study treatment due an AE is presented.|Up to approximately 112 days|The population consisted of all participants in whom a vaginal ring was inserted.|||Participants|||Number
2560093|NCT02668822|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who experienced an AE is presented.|Up to approximately 126 days|The population consisted of all participants in whom a vaginal ring was inserted.|||Participants|||Number
2560094|NCT02668822|Primary|Percentage of Participants With ≥3 Point Reduction in Peak Pelvic Pain Score and no Increase in Number of Ibuprofen Tablets Taken at Treatment Cycle 2, Compared to Baseline|Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The peak pelvic pain score was to be calculated as the highest (daily) pelvic pain score observed within the cramping window of the cycle and the total number of ibuprofen tablets taken was to be based on the 4-day cramping window. The baseline peak pelvic pain score and number of ibuprofen tablets taken were to be defined as the mean value of the 2 peak pelvic pain scores and the mean value of the total number of ibuprofen tablets taken during the cramping window of each of the 2 menstruations during the screening period, respectively. The percentage of participants with a reduction in peak pelvic pain score of ≥3 points and no increase in the use of ibuprofen at Treatment Cycle 2 as compared to baseline was to be presented.|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|The population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, the committee to determine cramping windows was not assembled, cramping windows were not determined & data could not be analyzed.||||||
2560095|NCT02668783|Secondary|Change From Baseline in Mean Pelvic Pain Score at Treatment Cycle 2|The mean pelvic pain score was to be calculated as the mean of the highest scores for pelvic pain observed within the 4-day cramping window of the screening or treatment cycle. The baseline mean pelvic pain score was to be defined as the mean value of the 2 mean pelvic pain scores of the 2 menstruations during the screening period. The change from baseline in mean pelvic pain score at Treatment Cycle 2 was to be presented.|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|Population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, committee to determine cramping windows was not assembled, cramping windows were not determined & efficacy data could not be analyzed.||||||
2560141|NCT02667912|Secondary|Changes of Daytime Mean Diastolic BP||From baseline to 12 months|ITT analysis by Last Observation Carried Forward (LOCF). (Six month data were used in 4 late (>6 months) dropouts and also in 1 patient without 12 month’ ABPM, 1 month data were used in 2 early (<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis)|||mmHg||Standard Deviation|Mean
2560142|NCT02667912|Secondary|Changes of Daytime Mean Diastolic BP||From baseline to 6 months|PPS|||mmHg||Standard Deviation|Mean
2560096|NCT02668783|Secondary|Percentage of Participants With ≥3 Point Reduction in Peak Pelvic Pain Score and a Decrease in Ibuprofen Tablet Intake at Treatment Cycle 2, Compared to Baseline|Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The baseline peak pelvic pain score and number of ibuprofen tablets taken were to be defined as the mean value of the 2 peak pelvic pain scores and the mean value of the total number of ibuprofen tablets taken during the cramping window of each of the 2 menstruations during the screening period, respectively. The percentage of participants with a reduction in peak pelvic pain score of ≥3 points and a decrease in the use of ibuprofen at Treatment Cycle 2 as compared to baseline was to be presented.|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|Population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, committee to determine cramping windows was not assembled, cramping windows were not determined & efficacy data could not be analyzed.||||||
2560097|NCT02668783|Secondary|"Percentage of Participants With Pelvic Pain Score of 0 or 1 and no Use of Ibuprofen Tablets at Treatment Cycle 2"|"Participants were asked to rate their worst pain or cramps on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The percentage of participants with no or minimal pelvic pain (score of 0 or 1) and no use of ibuprofen at Treatment Cycle 2 was to be presented."|Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|Population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during Treatment Cycle 2. Due to termination, committee to determine cramping windows was not assembled, cramping windows were not determined & efficacy data could not be analyzed.||||||
2560098|NCT02668783|Secondary|Change From Baseline in the Number of Days With no Impact on Items of Physical, Work/School and Social/Leisure Activities at Treatment Cycle 2|Participants were asked to indicate how much pain or cramps limited their physical, work/school and social/leisure activities and over the previous 24 hours. The level of negative impact of dysmenorrhea on daily life was scored on a 5-point scale (0=Not at all to 4=Extremely impacted). For each of the 3 impact items, the baseline score was to be defined as the mean value obtained from the 2 menstruations during the screening period. The change from baseline to Treatment Cycle 2 in the number of days during the cramping window with no impact of dysmenorrhea (score = 0) on each of the following items was to be presented: work/school, physical activities and leisure/social activities.|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|Population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, committee to determine cramping windows was not assembled, cramping windows were not determined & efficacy data could not be analyzed.||||||
2560099|NCT02668783|Secondary|Change From Baseline in Peak Pelvic Pain Score at Treatment Cycle 2|"Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps).~The peak pelvic pain score was to be calculated as the highest (daily) pelvic pain score observed within the 4-day cramping window of the cycle. The baseline peak pelvic pain score was to be defined as the mean value of the 2 peak pelvic pain scores during the cramping window of each of the 2 menstruations during the screening period. The change from baseline in peak pelvic pain score at Treatment Cycle 2 was to be presented."|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|Population was to consist of all participants in whom a vaginal ring was inserted & who had ≥1 day of diary entry each within 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, committee to determine cramping windows was not assembled, cramping windows were not determined & efficacy data could not be analyzed.||||||
2560100|NCT02668783|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who discontinued study treatment due to an AE is presented.|Up to approximately 128 days|All randomized participants in whom a vaginal ring was inserted.|||Participants|||Number
2560101|NCT02668783|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who experienced an AE is presented.|Up to approximately 158 days|All randomized participants in whom a vaginal ring was inserted.|||Participants|||Number
2560102|NCT02668783|Primary|Percentage of Participants With ≥3 Point Reduction in Peak Pelvic Pain Score and no Increase in Number of Ibuprofen Tablets Taken at Treatment Cycle 2, Compared to Baseline.|Participants were asked to rate their worst pain or cramps in the past 24 hours on a scale of 0 to 10 (0=No pain or cramps to 10=Extreme pain or cramps) and to indicate the number of ibuprofen tablets they took during the 4-day cramping window. The peak pelvic pain score was to be calculated as the highest (daily) pelvic pain score observed within the cramping window of the cycle and the total number of ibuprofen tablets taken was to be based on the 4-day cramping window. The baseline peak pelvic pain score and number of ibuprofen tablets taken were to be defined as the mean value of the 2 peak pelvic pain scores and the mean value of the total number of ibuprofen tablets taken during the cramping window of each of the 2 menstruations during the screening period, respectively. The percentage of participants with a reduction in peak pelvic pain score of ≥3 points and no increase in the use of ibuprofen at Treatment Cycle 2 as compared to baseline was to be presented.|Baseline 4-day cramping window and Treatment Cycle 2 4-day cramping window, as determined by committee for each participant|Population was to consist of all participants in whom vaginal ring was inserted & who had ≥1 day of diary entry each within a 4-day cramping window during a baseline cycle & a treatment cycle. Due to termination, committee to determine cramping windows was not assembled, cramping windows were not determined & efficacy data could not be analyzed.||||||
2560146|NCT02667912|Secondary|Changes of Office Diastolic BP||From baseline to 6 months|PPS|||mmHg||Standard Deviation|Mean
2560103|NCT02668640|Secondary|Percentage of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22.|Baseline, Week 12, and Week 24|Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data|||percentage of participants|||Number
2560104|NCT02668640|Secondary|Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22.|Baseline, Week 12, and Week 24|Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data|||Participants|||Count of Participants
2560105|NCT02668640|Secondary|Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Activity Impairment Score|The Work Productivity and Activity Impairment Questionnaire (WPAI) is a participant-reported questionnaire to measure work and activity impairment during the past seven days. Activity impairment was calculated via WPAI question 6, the participant's rating of how much rheumatoid arthritis affected their ability to do regular daily activities, other than working at a job (0 = no effect; 10 = completely impacted productivity) / 10 * 100. Negative values indicate improvement from baseline.|Baseline, Week 12, and Week 24|Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data|||percent impairment||Inter-Quartile Range|Median
2560106|NCT02668640|Secondary|Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Overall Work Impairment Score|The Work Productivity and Activity Impairment Questionnaire (WPAI) is a participant-reported questionnaire to measure work and activity impairment during the past seven days. The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the participant's rheumatoid arthritis impair the productivity while working past seven days from visit). Data were calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent, with higher numbers indicating greater impairment and less productivity. Negative values indicate improvement from baseline.|Baseline, Week 12, and Week 24|Observed population: participants continuing adalimumab treatment after the baseline visit who had at least Baseline data for this endpoint|||percent impairment||Inter-Quartile Range|Median
2560107|NCT02668640|Secondary|Median Change From Baseline in EuroQol 5-dimension, 3-level Quality of Life Questionnaire (EQ-5D-3L) Index|The EQ-5D-3L measures the participant's overall health state in a descriptive system of health-related quality of life (QoL) states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which has three response choices. The responses record three levels of severity ('no problems', 'having some or moderate problems', and 'being unable to do/extreme problems') within a particular EQ-5D-3L dimension. In addition, a 20 cm visual analogue scale (VAS) measures the participant's self-rated current health state on a scale from 0-100, from 0 (worst imaginable health state) to 100 ('best imaginable health state). The EQ-5D-3L results were converted into a weighted health state index with scores ranging from approximately 0 (death) to 1 (full health). A positive change from baseline indicates improvement.|Baseline, Week 12, and Week 24|Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data|||units on a scale||Inter-Quartile Range|Median
2560108|NCT02668640|Secondary|Median Change From Baseline in Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Scores at Weeks 12 and 24|The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 PCS and MCS scores range from 1-100: higher scores indicate a better state of health and an increase from baseline represents improvement.|Baseline, Week 12, and Week 24|Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data|||units on a scale||Inter-Quartile Range|Median
2560109|NCT02668640|Secondary|Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 12|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative median indicates improvement from baseline.|Baseline and Week 12|Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data|||units on a scale||Inter-Quartile Range|Median
2561399|NCT02650921|Secondary|GAIS by Treating Investigator|Global Aesthetic Improvement Scale|16 weeks|ITT|||Participants|||Count of Participants
2560110|NCT02668640|Primary|Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 24|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative median indicates improvement from baseline.|Baseline and Week 24|Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data|||units on a scale||Inter-Quartile Range|Median
2560111|NCT02668432|Secondary|Intensive Care Unit Length of Stay (ICU LOS)|Number of days spent in intensive care unit after admission.|28 days||||days||Inter-Quartile Range|Median
2560112|NCT02668432|Secondary|28-day Mortality|Survival to 28 days post initiation of treatment.|28 days||||participants|||Number
2560113|NCT02668432|Secondary|Concomitant Rhythm Control Medication or Intervention Use|Use of additional medications used with amiodarone to control heart rhythm.|7 days|Outcome measure data were not collected or analyzed for this outcome, study terminated early due to lack of funding and due to Investigator leaving institution||||||
2560114|NCT02668432|Secondary|Percentage of Time of Concomitant Rate Control Medication Use|Percentage of time of Additional medications used to control heart rate in addition to amiodarone. The reported data represents a cumulative percentage of time for the entire group of participants.|7 days||||percentage of time|||Number
2560115|NCT02668432|Secondary|Percentage of Time of Dobutamine Use|Percentage of time of use of Dobutamine in addition to amiodarone intervention. The reported data represents a cumulative percentage of time for the entire group of participants.|7 days||||percentage of time|||Number
2560116|NCT02668432|Secondary|Percentage of Time of Corticosteroid Use|Percentage of time of use of a corticosteroid for treatment in addition to amiodarone use. The reported data represents a cumulative percentage of time for the entire group of participants.|7 days||||percentage of time|||Number
2560117|NCT02668432|Secondary|Percentage of Time of Vasopressor Phenylephrine Use|Percentage of time of use of the vasopressor Phenylephrine in addition to amiodarone. The reported data represents a cumulative percentage of time for the entire group of participants.|7 days||||percentage of time|||Number
2560118|NCT02668432|Secondary|Percentage Time of Vasopressor Vasopressin Use|Percentage time of use of the vasopressor Vasopressin in addition to amiodarone. The reported data represents a cumulative percentage of time for the entire group of participants.|7 days||||percentage of time|||Number
2560119|NCT02668432|Secondary|Percentage Time of Vasopressor Norepinephrine Use|Percentage time of Use of the vasopressor Norepinephrine in addition to the amiodarone. The reported data represents a cumulative percentage of time for the entire group of participants.|7 days||||percentage of time|||Number
2560120|NCT02668432|Secondary|Heart Rate (HR)|Heart rate (HR) measured over 7 days|7 days||||Beats per minute||Full Range|Mean
2560121|NCT02668432|Secondary|Systolic Blood Pressure (SBP)|Systolic blood pressure (SBP) measured over 7 days|7 days||||mmHg||Full Range|Mean
2560122|NCT02668432|Secondary|Mean Arterial Pressure (MAP)|Mean arterial pressure (MAP) measured over 7 days|7 days||||mmHg||Full Range|Mean
2560123|NCT02668432|Secondary|Percentage of Time Patients Spent in Atrial Fibrillation|Percentage of time in atrial fibrillation vs normal sinus rhythm or other during a 7 day period. The reported data represents a cumulative percentage of time for the entire group of participants.|7 days||||percentage of time|||Number
2560124|NCT02668432|Secondary|Percentage of Time of Conversion to Normal Sinus Rhythm|Percentage of time patients spent with conversion from atrial fibrillation to normal sinus rhythm. The reported data represents a cumulative percentage of time for the entire group of participants.|7 days||||percentage of time|||Number
2560125|NCT02668432|Secondary|Percentage of Time Spent Hemodynamically Unstable After Initiation of Amiodarone Infusion to Day 7 or Death|Hemodynamic instability: 1. SBP <90 mmHg OR MAP < 70 mmHg AND HR ≥ 120 bp for ≥ 2 hours OR 2. HR ≥ 120 for ≥ 2 hours OR 3. Fluid boluses ± vasopressors or dobutamine. The reported data represents a cumulative percentage of time for the entire group of participants.|7 days||||percentage of time|||Number
2560126|NCT02668432|Primary|Mean HR Every 6 Hours Within the First 7 Days|"Evaluate two amiodarone dosing strategies, a full loading dose versus a partial loading dose, in patients with new-onset atrial fibrillation (AF) due to severe sepsis or septic shock to assess the effect on:~• Mean heart rate every 6 hours within the first 7 days following initiation of amiodarone"|7 days||||Beats per minute||Standard Error|Least Squares Mean
2560127|NCT02668302|Primary|Inflammation Score|Inflammation score was determined at baseline and Day 90 using a visual analogue scale (VAS), ranging from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes), as determined by an independent sinus surgeon based on a centralized, blinded video-endoscopy review.|Change from baseline to Day 90|Intent-to-treat population (all randomized participants). Values adjusted for any surgical or steroid intervention by caring forward last observation before intervention. Scores for 9 participants (7 treatment, 2 control) were missing because the video-endoscopies for those participants had insufficient content to allow grading.|||units on a scale||Standard Deviation|Mean
2560128|NCT02668198|Primary|Positive Recurrent Adenomas Using Biopsy|The number of positive diagnoses determined by standard histopathology assessment of biopsy.|approximately 6 to 12 months post endoscopic mucosal resection||||adenomas with positive diagnoses|||Number
2560129|NCT02668198|Primary|Positive Recurrent Adenomas Using Narrow Band Imaging Near Focus Confirmed by Histology|The number of recurrent adenomas diagnosed positive with narrow band imaging near focus confirmed by standard histopathology of biopsy.|approximately 6 to 12 months post endoscopic mucosal resection||||adenomas confirmed positive diagnoses|||Number
2560130|NCT02668198|Primary|Positive Recurrent Adenomas Using Narrow Band Imaging Near Focus|The number of positive diagnoses using narrow band optical imaging near focus only.|approximately 6 to 12 months post endoscopic mucosal resection||||adenomas with positive diagnoses|||Number
2560147|NCT02667912|Secondary|Changes of Office Systolic BP||From baseline to 12 months|ITT analysis by Last Observation Carried Forward (LOCF) method in the subjects with the available data . (Six month data were used in 4 late (>6 months) dropouts and also in 1 patient without 12 month’ ABPM, 1 month data were used in 2 early (<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis)|||mmHg||Standard Deviation|Mean
2560148|NCT02667912|Secondary|Changes of Office Systolic BP||From baseline to 6 months|PPS|||mmHg||Standard Deviation|Mean
2560149|NCT02667912|Secondary|Changes of 24h-mean Diastolic BP||From baseline to 12 months|ITT analysis by Last Observation Carried Forward (LOCF) method in the subjects with the available data . (Six month data were used in 4 late (>6 months) dropouts and also in 1 patient without 12 month’ ABPM, 1 month data were used in 2 early (<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis)|||mmHg||Standard Deviation|Mean
2560150|NCT02667912|Secondary|Changes of 24h-mean Systolic BP||From baseline to 12 months|ITT analysis by Last Observation Carried Forward (LOCF) method in the subjects with the available data . (Six month data were used in 4 late (>6 months) dropouts and also in 1 patient without 12 month’ ABPM, 1 month data were used in 2 early (<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis)|||mmHg||Standard Deviation|Mean
2560151|NCT02667912|Secondary|Changes of 24h-mean Diastolic BP||From baseline to 6 months|PPS|||mmHg||Standard Deviation|Mean
2560152|NCT02667912|Secondary|Changes of Estimated Glomerular Filtration Rate (eGFR)||From baseline to 12 months|ITT analysis by Last Observation Carried Forward (LOCF) method in the subjects with the available data. (Six month data were used in 4 late (>6 months) dropouts and also in 1 patient without 12 month’ ABPM, 1 month data were used in 2 early (<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis)|||ml/min/square meter||Standard Deviation|Mean
2560153|NCT02667912|Secondary|Changes of Estimated Glomerular Filtration Rate (eGFR)||From baseline to 6 months|The subjects with available data|||ml/min/square meter||Standard Deviation|Mean
2560154|NCT02667912|Secondary|Changes of Serum Creatinine||From baseline to 12 months|Intention-to-treat (ITT) analysis by Last Observation Carried Forward (LOCF) method. (Six month data were used in 4 late (>6 months) dropouts and also in 1 patient without 12 month’ ABPM, 1 month data were used in 2 early (<6 months) dropouts. One patient had no post procedure data at all and was excluded from analysis)|||μmol/l||Standard Error|Mean
2560155|NCT02667912|Secondary|Changes of Serum Creatinine||From baseline to 6 months||||μmol/l||Standard Deviation|Mean
2560156|NCT02667912|Secondary|Changes of Arterial Resistance Index Measured by Doppler Flowmetry in the Left Segmental Renal Arteries|Resistance index calculated as the relative difference between a peak systolic and end diastolic blood flow velocities assessed by ultrasound Doppler flowmetry|From baseline to 6 months||||ratio||Standard Deviation|Mean
2560157|NCT02667912|Secondary|Changes of Arterial Resistance Index Measured by Doppler Flowmetry in the Right Segmental Renal Arteries|Resistance index is calculated as the relative difference between a peak systolic and end diastolic blood flow velocities assessed by ultrasound Doppler flowmetry|From baseline to 6 months|Per protocol set (PPS)|||ratio||Standard Deviation|Mean
2560158|NCT02667912|Secondary|Number of Adverse Events||From baseline to 12 months|A baseline population except those who refused to continue in the study before final assessment and thereby whose status was unknown at 12 months follow up (5 in the distal denervation arm and 3 patients in conventional denervation arm).|||adverse event|||Number
2560159|NCT02667912|Secondary|Number of Adverse Events||From baseline to 6 months||||adverse event|||Number
2560160|NCT02667912|Primary|Changes of 24h-mean Systolic BP Assessed by Ambulatory Blood Pressure Monitoring (ABPM)||From baseline to 6 months|The subjects who completed 6 months follow up without serious violations of the study protocol - per protocol set|||mmHg||Standard Deviation|Mean
2560161|NCT02667821|Other Pre-specified|Changes in Blood Flow Through Vertebral Artery|Phase contrast MRI provides velocity measurements that can be used for analysis of the blood flow and tissue motion. At the level of C1-2, the contralateral and ipsilateral vertebral arteries (VA), defined to the direction of head motion, were assessed and anatomical images were established to localize the VA circulation. Mean and SDs were calculated for VA blood flow (mL/s) for each of the head conditions and VA side. Differences between task maneuvers and VA flow and velocity were evaluated using a repeated-measures analysis of variance with factors of head position and VA side, and a level of significance was set at .05|The series of fMRI sequences will be performed on each participant immediately after each procedure.||||mL/s||Standard Deviation|Mean
2560162|NCT02667821|Secondary|Changes in Tissue Perfusion in the Posterior Cerebrum and Cerebellum Will be Assessed Using Arterial Spin Labeling (ASL) MRI Technique.|ASL allows one to separate the blood flow from the BOLD effect, thus giving clear measures of perfusion. More specifically ASL will be used to measure blood perfusion and allow extraction of metabolic difference from flow differences in BOLD imaging. It is a quantitative technique, yielding values with units of ml/(100g of tissue)·min-1.|The series of ASL sequences will be performed on each participant immediately after each condition. Through study completion, data will be presented after an average of 1 year.||||ml/100g of tissue/minute||Standard Deviation|Mean
2560163|NCT02667821|Primary|Changes in Blood Flow Through the Vertebral Artery and Posterior Cerebral and Cerebellar Circulation|Phase contrast MRI provides velocity measurements that can be used for analysis of the blood flow and tissue motion. At the level of C1-2, the contralateral and ipsilateral vertebral arteries (VA), defined to the direction of head motion, were assessed and anatomical images were established to localize the VA circulation. Mean and SDs were calculated for VA blood velocity (cm/s) for each of the head conditions and VA side. Differences between task maneuvers and VA flow and velocity were evaluated using a repeated-measures analysis of variance with factors of head position and VA side, and a level of significance was set at .05|The series of fMRI sequences will be performed on each participant immediately after each condition. Through study completion, data will be presented after an average of 1 year.||||cm/s||Standard Deviation|Mean
2560186|NCT02667626|Primary|Number of Participants Using a WHO Class I or II Contraception|Use of World Health Organization Class I or II contraceptive methods (intrauterine devices, female sterilization, male partner sterilization, combined hormonal contraception, progestin implants or injections)|24 weeks||||Participants|||Count of Participants
2560164|NCT02667704|Secondary|Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)|Area under the concentration-time curve of Nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity). PK plasma samples were taken at: 1 hour (h) before drug administration and 30 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 144.5h, 145h, 145.5h, 146h, 146.5h, 147h, 148h, 149h, 150h, 152h, 154h, 156h, 168h, 180h, 192h, 216h after drug administration. Two different visits; Visit 2 (R): -1 to 72 h, Visit 3 (T) 144 to 216 h. AUC0-infinity was calculated for each visit separately.|Up to 216 hours. The details are mentioned in description.|Pharmacokinetic parameter analysis set (PKS): all subjects in the treated set who provided at least one primary or secondary pharmacokinetic (PK) parameter not flagged for exclusion due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.|||ng*h / mL||Geometric Coefficient of Variation|Geometric Mean
2560165|NCT02667704|Primary|Maximum Measured Concentration of Nintedanib in Plasma (Cmax)|Maximum measured concentration of Nintedanib in plasma (Cmax). PK plasma samples were taken at: 1 hour (h) before drug administration and 30 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 144.5h, 145h, 145.5h, 146h, 146.5h, 147h, 148h, 149h, 150h, 152h, 154h, 156h, 168h, 180h, 192h, 216h after drug administration. Two different visits; Visit 2 (R): -1 to 72 h, Visit 3 (T) 144 to 216 h. Cmax was determined for each visit separately.|Up to 216 hours. The details are mentioned in description.|Pharmacokinetic parameter analysis set (PKS): all subjects in the treated set who provided at least one primary or secondary pharmacokinetic (PK) parameter not flagged for exclusion due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2560166|NCT02667704|Primary|Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 to the Last Quantifiable Concentration (AUC0-tz)|Area under the concentration-time curve of Nintedanib in plasma over the time interval from 0 to the last quantifiable concentration (AUC0-tz). PK plasma samples were taken at: 1 hour (h) before drug administration (approximate time for predose sample) and 30 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 144.5h, 145h, 145.5h, 146h, 146.5h, 147h, 148h, 149h, 150h, 152h, 154h, 156h, 168h, 180h, 192h, 216h after drug administration. Two different visits; Visit 2 (R): -1 to 72 h, Visit 3 (T) 144 to 216 h. AUC0-tz was calculated for each visit separately.|Up to 216 hours. The details are mentioned in description.|Pharmacokinetic parameter analysis set (PKS): all subjects in the treated set who provided at least one primary or secondary pharmacokinetic (PK) parameter not flagged for exclusion due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.|||nanogram (ng)*hour (h) /millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
2560167|NCT02667639|Secondary|RPH-104 - Maximum Plasma Concentration (Cmax)|Mean Cmax. Highest concentration determined in the measuring interval.|Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30||||ng/mL||Standard Deviation|Mean
2560168|NCT02667639|Secondary|RPH-104 - Elimination Half-life (t1/2)|Mean t½. Definition of t½ is terminal elimination half-life.|Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30||||hr||Standard Deviation|Mean
2560169|NCT02667639|Secondary|RPH-104 - Time to Maximum Concentration (Tmax)|Median Tmax. Definition of Tmax is time at which Cmax occurs.|Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30||||hr||Full Range|Median
2560170|NCT02667639|Secondary|RPH-104 - Area Under the Curve (AUC)|Mean AUC 0-t (area under the concentration- time curve from time zero to day 30)|Day 1, Day 2, Day3, Day 4, Day 5, Day 6, Day 9, Day 12, Day 15, Day 20, Day 25, Day 30||||hr*ng/mL||Standard Deviation|Mean
2560171|NCT02667639|Primary|Clinical Laboratory Tests|Percentage of participants with abnormal clinical laboratory tests. Normal laboratory ranges of the central laboratory were used.|Until 30 days after administration||||percentage of participants|||Number
2560172|NCT02667639|Primary|Body Temperature|Percentage of participants with abnormal body temperature. Among adults, the average body temperature ranges from 97°F (36.1°C) to 99°F (37.2°C).|Until 30 days after administration||||percentage of participants|||Number
2560173|NCT02667639|Primary|Oxygen Saturation|Percentage of participants with abnormal oxygen saturation. Normal pulse oximeter readings usually range from 95 to 100 percent. Values under 90 percent are considered low.|Until 30 days after administration||||percentage of participants|||Number
2560174|NCT02667639|Primary|Blood Pressure|Percentage of participants with abnormal blood pressure. An optimal blood pressure level is a reading under 120/80 mmHg|Until 30 days after administration||||percentage of participants|||Number
2560175|NCT02667639|Primary|Respiratory Rate|Percentage of participants with abnormal respiratory rate. The normal respiration rate for an adult at rest is 12 to 20 breaths per minute.|Until 30 days after administration||||percentage of participants|||Number
2560176|NCT02667639|Primary|Serious Adverse Events|Number of Participants with Study Drug Related Serious Adverse Events|Until 60 days after administration||||Participants|||Count of Participants
2560177|NCT02667639|Primary|Adverse Events|Number of participants with study drug related adverse events|Until 60 days after administration||||participants|||Number
2560178|NCT02667626|Other Pre-specified|Menopause Quality of Life (MENQOL)|Change in score|12 and 24 weeks|||||||
2560179|NCT02667626|Other Pre-specified|Confidence for Managing Reproductive Health Issues Scale|Change in score|12 and 24 weeks|||||||
2560180|NCT02667626|Other Pre-specified|Female Sexual Function Inventory|Change in score|12 and 24 weeks|||||||
2560181|NCT02667626|Other Pre-specified|Insomnia Scale|Change in score|12 and 24 weeks|||||||
2560182|NCT02667626|Other Pre-specified|Social Support (MOS Social Support)|Change in score|12 and 24 weeks|||||||
2560183|NCT02667626|Other Pre-specified|Depression (PHQ-8)|Change in score|12 and 24 weeks|||||||
2560184|NCT02667626|Secondary|Healthcare Provider Preparedness Scale|Change in score|24 weeks|Data were not collected||||||
2560185|NCT02667626|Primary|Number of Participants With a 50% Decrease in Vulvovaginal Atrophy Score|The Vulvovaginal Atrophy Score is a 4-item scale on vaginal dryness, soreness, irritation and dyspareunia experienced in the prior 4 weeks]. Each item has a 4-point Likert scale response (0-none, 1-mild, 2-moderate, 3-severe). The scale is summarized by averaging responses, with higher scores indicating a greater level of vaginal atrophy.|Baseline and 24 weeks||||Participants|||Count of Participants
2560187|NCT02667626|Primary|Number of Participants With the Reproductive Concerns After Cancer Scale - Fertility Concerns Subscale Score <=3|Fertility concerns subscale score <=3. Scores for the fertility subscale calculated by averaging responses (range 1-5) to the 3 subscale questions. The minimum score is 1, the maximum score is 5, Higher scores indicate worse outcome.|24 weeks||||Participants|||Count of Participants
2560188|NCT02667626|Primary|Number of Participants With a 50% Decrease in Hot Flash Score|50% decrease in hot flash score. The hot flash score is calculated as the weighted sum of the number of hot flashes in each severity category multiplied by a severity-exclusive weight (1-mild, 2-moderate, 3-severe, 4-very severe). The minimum is 0 and there is no maximum. For example a woman can experience an unlimited number of hot flashes per day. Higher score indicates worse outcome.|Baseline and 24 weeks||||Participants|||Count of Participants
2560189|NCT02667288|Secondary|Per Subject Percent of Lesion Clearance|Physician Lesion Assessment (PWA) average Per-Subject Percent of target lesions judged to be clear at Visit 12 in the per protocol population. The PWA scale is a 4 point scale used by the investigator to assess the subject's Target SK lesions.|Day 148|Per Protocol Population|||percentage of lesions cleared||Standard Deviation|Mean
2560190|NCT02667288|Primary|Proportion of Subjects With Lesion Clearance|Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment (PWA) Scale. The PWA scale is a 4 point scale used by the investigator to assess each subject target SK Lesion.|Study day 148|ITT Population|||Participants|||Count of Participants
2560191|NCT02667275|Secondary|Percent of Lesions Cleared Scale|Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8|Study day 106||||Participants|||Count of Participants
2560192|NCT02667275|Primary|Proportion of Subjects With All Target Lesions Cleared According to Physician Lesion Assessment Scale|Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The Physician Lesion Assessment Scale is a 4 point scale used by the investigator to assess the subject's target sk lesions.|Study day 106||||Participants|||Count of Participants
2560193|NCT02667236|Secondary|Proportion of Subjects With 3 of 4 Target Lesion Clearance|Proportion of Subjects for whom at least 3 of 4 target lesions were judged to be clear on the Physician Lesion Assessment (PLA=0) at Visit 8|Day 106 of the study|ITT population; all randomized subjects|||Participants|||Count of Participants
2560194|NCT02667236|Primary|Proportion of Subjects With Target Lesion Clearance as Assessed by the Physician Lesion Assessment|Proportion of subjects for whom all target lesions were judged to be clear on the Physician Lesion Assessment Scale (PLA=0) at Visit 8. The PLA Scale is a 4 point scale used by the investigator to assess each subject's target SK Lesion.|Day 106 of the study|ITT Population; all randomized subjects|||Participants|||Count of Participants
2560195|NCT02666950|Other Pre-specified|Pharmacokinetic (PK) Parameters t1/2 of WEE1 Inhibitor AZD1775|PK will be primarily descriptive|Day 1, course 1; pre-treatment, 30 min, 1 hr, 2 hr, 4 hr, 6hr and 24 hr after WEE1 inhibitor AZD administration|||||||
2560196|NCT02666950|Other Pre-specified|Pharmacokinetic (PK) Parameters Tmax of WEE1 Inhibitor AZD1775|PK will be primarily descriptive|Day 1, course 1; pre-treatment, 30 min, 1 hr, 2 hr, 4 hr, 6hr and 24 hr after WEE1 inhibitor AZD administration|||||||
2560197|NCT02666950|Other Pre-specified|Pharmacokinetic (PK) Parameters Cmax of WEE1 Inhibitor AZD1775|PK will be primarily descriptive|Day 1, course 1; pre-treatment, 30 min, 1 hr, 2 hr, 4 hr, 6hr and 24 hr after WEE1 inhibitor AZD administration|||||||
2560198|NCT02666950|Other Pre-specified|Pharmacokinetic (PK) Parameters Vd of WEE1 Inhibitor AZD1775|PK will be primarily descriptive.|Day 1, course 1; pre-treatment, 30 min, 1 hr, 2 hr, 4 hr, 6hr and 24 hr after WEE1 inhibitor AZD administration|||||||
2560199|NCT02666950|Other Pre-specified|Pharmacokinetic (PK) Parameters AUC of WEE1 Inhibitor AZD1775|PK will be primarily descriptive.|Day 1, course 1; pre-treatment, 30 min, 1 hr, 2 hr, 4 hr, 6hr and 24 hr after WEE1 inhibitor AZD administration|||||||
2560200|NCT02666950|Other Pre-specified|Change in QOL as Assessed by the European Organization for Treatment and Research of Cancer Quality of Life Questionnaire Core Questionnaire 30|Scale score trajectories over time and changes from baseline over time will be examined using repeated measures or growth curve models, as appropriate, stream plots and mean plots with standard deviation error bars overall. Scores and changes at each cycle will be statistically tested using paired t-tests, and standardized response means (i.e. effect sizes) (mean of the change from baseline scores at a given cycle, divided by the standard deviation of the change scores) will be interpreted (after applying Middel's adjustment) using Cohen's cut-offs.|Baseline to 2 years|||||||
2560201|NCT02666950|Other Pre-specified|Change in Patients' Reported Outcomes as Assessed by the Brief Fatigue Inventory (BFI)|BFI, as well as linear analog scales capturing early satiety, abdominal discomfort, inactivity, concentration problems, numbness/tingling in the hands/feet, night sweats, itching, bone pain, fever, and weight loss will be used.|Baseline to 2 years|||||||
2560202|NCT02666950|Other Pre-specified|Change in Biomarker Levels|Continuous biomarker levels will be explored in a graphical manner including mean plots and plots of change and percent change from baseline and other summary measures. Any potential relationships between the baseline level or change in the level of each biomarker and clinical outcome such as overall response, 6-month progression and survival, and adverse event incidence will be further analyzed using Wilcoxon rank sum tests or logistic regression methods, as appropriate. Association between a dichotomized biomarker and overall response will be assessed using a chi-squared test.|Baseline to up to 113 days (after course 4)|||||||
2560203|NCT02666950|Secondary|Time to Response, Defined as the Time From Registration to the Earliest Date of Documentation of Response|Time to response, defined as the time from registration to the earliest date of documentation of response. The distribution of time to progression will be estimated using the method of Kaplan-Meier.|Up to 17 months|No patients responded, thus no patients were analyzed for this outcome measure. Since only one patient was accrued on one arm, patient confidentiality prevents the reporting of results by arm.||||||
2560249|NCT02666352|Primary|Tmax of Ruzasvir|Tmax is the time required to reach maximum plasma drug concentration (i.e., Cmax). The Tmax of ruzasvir 60 mg (given in combination with uprifosbuvir 450 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||hr||Full Range|Median
2560204|NCT02666950|Secondary|Time to Progression, Defined as the Time From Registration to the Earliest Date of Documentation of Disease Progression|Time to progression (TTP) is defined to be the length of time from study registration to a) date of disease progression as defined by section 11.0 of the protocol, or b) last follow-up. If a patient dies without documentation of disease progression, the patient will be considered to have had a tumor progression at the time of death unless there is sufficient documented evidence to conclude no progression occurred prior to death. Time to progression curves were compared via the log-rank test. Progression is defined as a >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions compared to pretreatment MRI and/or CT scan.|Up to 17 months|Since only one patient was accrued on one arm, patient confidentiality prevents the reporting of results by arm.|||months||Full Range|Median
2560205|NCT02666950|Secondary|Overall Survival|Overall survival time is defined as the time from registration to death due to any cause.|From registration to death due to any cause, assessed up to 17 months|Since only one patient was accrued on one arm, patient confidentiality prevents the reporting of results by arm.|||months||Full Range|Median
2560206|NCT02666950|Secondary|Percentage of Participants With Grade 3 or Higher Adverse Events Considered At Least Possibly Related to Treatment|"The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below."|Up to 30 days post-treatment|Since only one patient was accrued on one arm, patient confidentiality prevents the reporting of results by arm.|||percentage of patients|||Number
2560207|NCT02666950|Secondary|Duration of Response|Duration of response defined for all evaluable patients who have achieved a response as the date at which the patient's earliest best objective status is first noted to be a CR/CRi response to the earliest date progression is documented|Up to 17 months|No patients responded, thus no patients were analyzed for this outcome measure. Since only one patient was accrued on one arm, patient confidentiality prevents the reporting of results by arm.||||||
2560208|NCT02666950|Secondary|Clinical Benefit as Measured by the Number of Patients Who Were Not RBC Transfusion-dependent Post-Baseline|Clinical benefit as measured by the number of patients who did not receive a RBC transfusion post-Baseline|Up to 17 months|Since only one patient was accrued on one arm, patient confidentiality prevents the reporting of results by arm.|||Participants|||Count of Participants
2560209|NCT02666950|Primary|Complete Response Rate (CR or CRi) Per the National Comprehensive Cancer Network (NCCN) Guidelines or According to Specific Criteria From Expert Panels|Complete response rate will be evaluated over all courses of study treatment. The proportion of CR/CRi responses will be estimated by the number of CR/CRi responses divided by the total number of evaluable patients.|Up to 17 months|Since only one patient was accrued on one arm, patient confidentiality prevents the reporting of results by arm.|||percentage of patients|||Number
2560210|NCT02666664|Other Pre-specified|Percentage of Participants Achieving LDL-C <70 mg/dL at Week 12, 24, and 52|The percentage of participants who achieved lowering in lipid values of LDL-C below 70 mg/dL have been reported. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Observed data was used for the analysis, no imputation for the missing data was performed.|Week 12, Week 24, and Week 52|Full Analysis Set. Only participants with available data were analyzed.|||Percentage of participants|||Number
2560211|NCT02666664|Other Pre-specified|Percent Change From Baseline to Week 52 in hsCRP|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the last value prior to first dose of study drug. Percent change from baseline was calculated as: [(hsCRP value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed.|Baseline; Week 52|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Inter-Quartile Range|Median
2560212|NCT02666664|Other Pre-specified|Percent Change From Baseline to Week 24 in hsCRP|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the last value prior to first dose of study drug. Percent change from baseline was calculated as: [(hsCRP value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed.|Baseline; Week 24|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Inter-Quartile Range|Median
2560213|NCT02666664|Other Pre-specified|Percent Change From Baseline to Week 52 in apoB|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apoB. Baseline was defined as the last value prior to first dose of study drug. Percent change from baseline was calculated as: [(apoB value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed.|Baseline; Week 52|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Standard Deviation|Mean
2560214|NCT02666664|Other Pre-specified|Percent Change From Baseline to Week 24 in apoB|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apoB. Baseline was defined as the last value prior to first dose of study drug. Percent change from baseline was calculated as: [(apoB value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed|Baseline; Week 24|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Standard Deviation|Mean
2560250|NCT02666352|Primary|C24hr of Ruzasvir|C24hr is a measure of plasma drug concentration 24 hours after dosing. The C24hr of ruzasvir 60 mg (given in combination with uprifosbuvir 450 mg) was calculated for each arm.|24 hours post-dose|All participants are included in the analysis.|||nM||95% Confidence Interval|Geometric Least Squares Mean
2561400|NCT02650921|Secondary|GAIS by Treating Investigator|Global Aesthetic Improvement Scale|12 weeks|ITT|||Participants|||Count of Participants
2560215|NCT02666664|Other Pre-specified|Percent Change From Baseline to Week 52 in TC|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(TC value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed.|Baseline; Week 52|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Standard Deviation|Mean
2560216|NCT02666664|Other Pre-specified|Percent Change From Baseline to Week 24 in TC|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(TC value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed.|Baseline; Week 24|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Standard Deviation|Mean
2560217|NCT02666664|Other Pre-specified|Percent Change From Baseline to Week 52 in Non-HDL-C|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for non-HDL-C. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(non-HDL-C value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed.|Baseline; Week 52|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Standard Deviation|Mean
2560218|NCT02666664|Other Pre-specified|Percent Change From Baseline to Week 24 in Non-HDL-C|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for non-HDL-C. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(non-HDL-C value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed.|Baseline; Week 24|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Standard Deviation|Mean
2560219|NCT02666664|Other Pre-specified|Percent Change From Baseline to Week 52 in LDL-C|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(LDL-C value at Week 52 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate.|Baseline; Week 52|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Standard Error|Least Squares Mean
2560220|NCT02666664|Other Pre-specified|Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the last value prior to first dose of study drug. Percent change from baseline was calculated as: [(hsCRP value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Observed data was used for the analysis, no imputation for the missing data was performed. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate.|Baseline; Week 12|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Standard Error|Least Squares Mean
2560221|NCT02666664|Other Pre-specified|Percent Change From Baseline to Week 12 in Apolipoprotein B (apoB)|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apoB. Baseline was defined as the last value prior to first dose of study drug. Percent change from baseline was calculated as: [(apoB value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate.|Baseline; Week 12|Full Analysis Set. Only participants with available data were analyzed.|||percent change||Standard Error|Least Squares Mean
2560222|NCT02666664|Other Pre-specified|Percent Change From Baseline to Week 12 in Total Cholesterol (TC)|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(TC value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate.|Baseline; Week 12|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
2560223|NCT02666664|Other Pre-specified|Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for non-HDL-C. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(non-HDL-C value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate.|Baseline; Week 12|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
2560251|NCT02666352|Primary|Maximum Plasma Drug Concentration (Cmax) of Ruzasvir|Cmax is the maximum observed plasma drug concentration after dosing. The Cmax for ruzasvir 60 mg (given in combination with uprifosbuvir 450 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||nM||95% Confidence Interval|Geometric Least Squares Mean
2560224|NCT02666664|Other Pre-specified|Percent Change From Baseline to Week 24 in LDL-C|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(LDL-C value at Week 24 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Percent change was analyzed using the ANCOVA method, which included treatment, randomization stratum as factors, and baseline value as covariate.|Baseline; Week 24|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
2560225|NCT02666664|Secondary|Absolute Change From Baseline to Week 12 in LDL-C|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Absolute change from baseline was calculated as: LDL-C value at Week 12 minus Baseline value. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen.|Baseline; Week 12|Full Analysis Set. Only participants with available data were analyzed.|||mg/dL||Standard Deviation|Mean
2560226|NCT02666664|Secondary|Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)|Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the values at screening (Week -2) and predose Day 1/Week 0. Percent change from baseline was calculated as: [(LDL-C value at Week 12 minus Baseline value) divided by (Baseline Value)] multiplied by 100. Missing data were imputed with the use of a pattern-mixture model to account for adherence to the trial regimen. Least Square mean= LS mean. Percent change was analyzed using the analysis of covariance (ANCOVA) method, which included treatment, randomization stratum as factors, and baseline value as covariate.|Baseline; Week 12|Full Analysis Set: all randomized participants|||percent change||Standard Error|Least Squares Mean
2560227|NCT02666664|Primary|Change From Baseline to Week 52 in Hemoglobin Level|Blood samples were drawn at defined time points during the course of the study to monitor hemoglobin levels.|Baseline and Week 52|Safety Population. Only participants with available data were analyzed.|||grams per deciliter (g/dL)||Standard Deviation|Mean
2560228|NCT02666664|Primary|Change From Baseline to Week 52 in Creatinine Level|Blood samples were drawn at defined time points during the course of the study to monitor creatinine levels.|Baseline and Week 52|Safety Population. Only participants with available data were analyzed.|||mg/dL||Standard Deviation|Mean
2560229|NCT02666664|Primary|Change From Baseline to Week 52 in Uric Acid (Urate) Level|Blood samples were drawn at defined time points during the course of the study to monitor uric acid (urate) levels.|Baseline and Week 52|Safety Population. Only participants with available data were analyzed.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2560230|NCT02666664|Primary|Percentage of Participants With the Indicated Event of Special Interest: Renal Disorder|"Treatment-emergent AESIs were predefined and monitored throughout the study. TEAEs potentially related to renal events were assessed using the following preferred terms: renal failure, renal impairment, acute kidney injury (system organ class: renal and urinary disorders); blood creatinine increased, glomerular filtration rate decreased, blood urea increased, estimated glomerular filtration rate (eGFR) <30 milliliter per minute per 1.73 square meter (ml/min/1.73m^2), and change from baseline in creatinine >1 mg/dL (system organ class: investigations); and gout (system organ class: metabolism and nutrition disorders). The percentage of unique participants is reported in the Overall renal disorder AESIs category; a participant could have been represented in more than one of the individual renal disorder AESIs."|Up to approximately 52 weeks|Safety Population|||percentage of participants|||Number
2560231|NCT02666664|Primary|Percentage of Participants With the Indicated Event of Special Interest: New Onset or Worsening Diabetes Mellitus|"Treatment-emergent AESIs were predefined and monitored throughout the study. New onset or worsening diabetes was assessed using the following preferred terms: type 2 diabetes mellitus, diabetes mellitus, hyperglycaemia, glucose tolerance impaired, diabetes mellitus inadequate control, and impaired fasting glucose (system organ class: metabolism and nutrition disorders); blood glucose increased, glycosylated haemoglobin increased, blood glucose abnormal, and glucose urine present (system organ class: investigations); and glycosuria (system organ class: renal and urinary disorders). The percentage of unique participants is reported in the Overall new onset/worsening diabetes mellitus AESIs category; a participant could have been represented in more than one of the individual new onset/worsening diabetes mellitus AESIs."|Up to approximately 52 weeks|Safety Population|||percentage of participants|||Number
2560232|NCT02666664|Primary|Percentage of Participants With the Indicated Event of Special Interest: Neurocognitive Disorder|"Treatment-emergent AESIs were predefined and monitored throughout the study. Neurocognitive disorder was assessed using the following preferred terms: memory impairment, amnesia, and cognitive disorder (system organ class: nervous system disorders); confusional state and disorientation (system organ class: psychiatric disorders). The percentage of unique participants is reported in the Overall neurocognitive disorder AESIs category; a participant could have been represented in more than one of the individual neurocognitive disorder AESIs."|Up to approximately 52 weeks|Safety Population|||percentage of participants|||Number
2560233|NCT02666664|Primary|Percentage of Participants With the Indicated Event of Special Interest: Muscular Disorder|"Treatment-emergent AESIs were predefined and monitored throughout the study. Muscular safety was assessed using the following preferred terms and laboratory abnormalities: myalgia, muscle spasms, pain in extremity, muscular weakness (system organ class: musculoskeletal and connective tissue disorders), and creatine kinase >5 ULN (repeated and confirmed). The percentage of unique participants is reported in the Overall muscular disorder AESIs category; a participant could have been represented in more than one of the individual muscular disorder AESIs."|Up to approximately 52 weeks|Safety Population|||percentage of participants|||Number
2560234|NCT02666664|Primary|Percentage of Participants With the Indicated Event of Special Interest: Metabolic Acidosis|Treatment-emergent AESIs were predefined and monitored throughout the study. Metabolic acidosis was assessed using the preferred term metabolic acidosis (system organ class: metabolism and nutrition disorders).|Up to approximately 52 weeks|Safety Population|||percentage of participants|||Number
2561401|NCT02650921|Secondary|Improvement in Hand as Evaluated by IPR|Independent Photographic Reviewer's assessment of improvement (Yes/No)|24 weeks|ITT|||Participants|||Count of Participants
2560235|NCT02666664|Primary|Percentage of Participants With the Indicated Event of Special Interest: Hypoglycemia|"Treatment-emergent AESIs were predefined and monitored throughout the study. Hypoglycemia was assessed using the following preferred terms: hypoglycaemia (system organ class: metabolism and nutrition disorders); blood glucose abnormal and blood glucose decreased (system organ class: investigations). The percentage of unique participants is reported in the Overall hypoglycemia AESIs category; a participant could have been represented in more than one of the individual hypoglycemia AESIs."|Up to approximately 52 weeks|Safety Population|||percentage of participants|||Number
2560236|NCT02666664|Primary|Percentage of Participants With the Indicated Event of Special Interest: Hepatic Disorders|"Treatment-emergent AESIs were predefined and monitored throughout the study. TEAEs potentially related to hepatic events were assessed using the following preferred terms and laboratory abnormalities: aspartate aminotransferase (AST) increased, Alanine aminotransferase (ALT) increased, Hepatic enzyme increased, Blood bilirubin increased, liver function test (LFT) abnormal, LFT increased, hepatic enzyme abnormal, transaminases increased, potential Hy's Law cases (PHLC) [AST and (&)/or ALT >3 x upper limit of normal (ULN) with concurrent total bilirubin >2 x ULN], AST and/or ALT >3 x ULN, and total bilirubin >2 x ULN (system organ class: investigations). AST and ALT values were repeated and confirmed. Repeated and confirmed was defined as a participant having the last on-study LFT > x ULN, the last on-treatment LFT > x ULN, or LFT > x ULN followed by another LFT > x ULN."|Up to approximately 52 weeks|"Safety Population. The percentage of unique participants is reported in the Overall hepatic disorder AESIs category; a participant could have been represented in more than one of the individual hepatic disorder AESIs."|||percentage of participants|||Number
2560237|NCT02666664|Primary|Percentage of Participants With the Indicated Event of Special Interest: Creatine Kinase Elevations|TEAEs of special interest (AESIs) were predefined and monitored throughout the study. Creatine kinase elevations were assessed using the following preferred term: Blood creatine phosphokinase increased (system organ class: investigations).|Up to approximately 52 weeks|Safety Population|||percentage of participants|||Number
2560238|NCT02666664|Primary|Percentage of Participants With Adjudicated Major Adverse Cardiovascular Event|TEAEs, defined as AEs that began or worsened in severity after the first dose of double-blind study drug and up to 30 days after receiving the last dose of double-blind study drug, were collected and reported. Cardiovascular events were considered as adverse events of special interest. Treatment-emergent = TE.|Up to approximately 52 weeks|Safety Population|||percentage of participants|||Number
2560239|NCT02666664|Primary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)|TEAEs, defined as adverse events (AEs) that began or worsened in severity after the first dose of double-blind study drug and up to 30 days after receiving the last dose of double-blind study drug, were collected and reported.|Up to approximately 52 weeks|Safety Population: all randomized participants who received at least 1 dose of investigational medicinal product. Participants were included in the treatment group that they received, regardless of their randomized treatment.|||percentage of participants|||Number
2560240|NCT02666560|Secondary|Time Spent in Single Support as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. This was record in percentage of time spent in double support (%).|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.||||percentage of time||Standard Deviation|Mean
2560241|NCT02666560|Secondary|Time Spent in Double Support as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. This was record in percentage of time spent in double support (%).|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.||||percentage of time||Standard Deviation|Mean
2560242|NCT02666560|Secondary|Cadence as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of cadence was recorded in steps per minute.|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.||||steps per minute||Standard Deviation|Mean
2560243|NCT02666560|Secondary|Step Time as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of step time was recorded in seconds.|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.||||seconds||Standard Deviation|Mean
2560244|NCT02666560|Secondary|Velocity as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of velocity was recorded in cm's per second.|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.||||cm/s||Standard Deviation|Mean
2560245|NCT02666560|Primary|Step Length as Measured by the Gaitrite Walk-way System.|The Gaitrite is a portable gait analysis walk-way system that enables the temprospatial measures of gait to be recorded. The temprospatial measure of length was recorded in centimetres.|Data was collected at a single time point for each condition. Conditions occurred within a two week time period.||||cm||Standard Deviation|Mean
2560246|NCT02666352|Primary|Vz/F of Ruzasvir|Vz/F is the apparent volume of distribution during the terminal phase after non-intravenous administration. The Vz/F of ruzasvir 60 mg (given in combination with uprifosbuvir 450 mg) was calculated for each arm.|Pre-dose (0) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||L||Geometric Coefficient of Variation|Geometric Mean
2560247|NCT02666352|Primary|CL/F of Ruzasvir|CL/F is a measure of the apparent rate at which drug is removed from the body via renal, hepatic, and other clearance pathways after oral administration. The CL/F of ruzasvir 60 mg (given in combination with uprifosbuvir 450 mg) was calculated for each arm.|Pre-dose (0) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2560248|NCT02666352|Primary|Apparent t1/2 of Ruzasvir|Apparent t1/2 is a measure of how long it takes to clear 50% of drug after reaching Cmax. The t1/2 for ruzasvir 60 mg (given in combination with uprifosbuvir 450 mg) was calculated for each arm.|Pre-dose (0) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||hr||Geometric Coefficient of Variation|Geometric Mean
2560252|NCT02666352|Primary|AUC0-24hr of Ruzasvir|AUC0-24hr is a measure of the mean plasma drug concentration from time of dosing to 24 hours post-dose. The AUC0-24hr for ruzasvir 60 mg (given in combination with uprifosbuvir 450 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose|All participants are included in the analysis.|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2560253|NCT02666352|Primary|AUC0-inf of Ruzasvir|AUC0-inf is a measure of the mean plasma drug concentration from time of dosing to infinity. The AUC0-inf for ruzasvir 60 mg (given in combination with uprifosbuvir 450 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2560254|NCT02666352|Primary|AUC0-last of Ruzasvir|AUC0-last is a measure of the mean plasma drug concentration from time of dosing to the last quantifiable sample. The AUC0-last for ruzasvir 60 mg (given in combination with uprifosbuvir 450 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2560255|NCT02666352|Primary|Apparent t1/2 of Uprifosbuvir Metabolite M6|Apparent t1/2 is a measure of how long it takes to clear 50% of drug after reaching Cmax. The t1/2 for the M6 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||hr||Geometric Coefficient of Variation|Geometric Mean
2560256|NCT02666352|Primary|Tmax of Uprifosbuvir Metabolite M6|Tmax is the time required to reach maximum plasma drug concentration (i.e., Cmax). The Tmax for the M6 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||hr||Full Range|Median
2560257|NCT02666352|Primary|C24hr of Uprifosbuvir Metabolite M6|C24hr is a measure of plasma drug concentration 24 hours after dosing. The C24hr of the M6 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|24 hours post-dose|All participants are included in the analysis.|||nM||95% Confidence Interval|Geometric Least Squares Mean
2560258|NCT02666352|Primary|Cmax of Uprifosbuvir Metabolite M6|Cmax is the maximum observed plasma drug concentration after dosing. The Cmax for the M6 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||nM||95% Confidence Interval|Geometric Least Squares Mean
2560259|NCT02666352|Primary|AUC0-24hr of Uprifosbuvir Metabolite M6|AUC0-24hr is a measure of the mean plasma drug concentration from time of dosing to 24 hours post-dose. The AUC0-24hr for the M6 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose|All participants are included in the analysis.|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2560260|NCT02666352|Primary|AUC0-inf of Uprifosbuvir Metabolite M6|AUC0-inf is a measure of the mean plasma drug concentration from time of dosing to infinity. The AUC0-inf for the M6 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2560261|NCT02666352|Primary|AUC0-last of Uprifosbuvir Metabolite M6|AUC0-last is a measure of the mean plasma drug concentration from time of dosing to the last quantifiable sample. The AUC0-last for the M6 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2560262|NCT02666352|Primary|Apparent t1/2 of Uprifosbuvir Metabolite M5|Apparent t1/2 is a measure of how long it takes to clear 50% of drug after reaching Cmax. The t1/2 for the M5 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||hr||Geometric Coefficient of Variation|Geometric Mean
2560263|NCT02666352|Primary|Tmax of Uprifosbuvir Metabolite M5|Tmax is the time required to reach maximum plasma drug concentration (i.e., Cmax). The Tmax for the M5 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||hr||Full Range|Median
2560264|NCT02666352|Primary|Lag Time (Tlag) for Uprifosbuvir Metabolite M5|"Tlag is a measure of the time delay between drug administration and the onset of absorption, where onset of absorption is defined as the time point prior to the first observed/measured non-zero plasma concentration. The Tlag of the M5 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm (in this study Tlag was only calculated for the M5 uprifosbuvir metabolite)."|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||hr||Full Range|Median
2560265|NCT02666352|Primary|C24hr of Uprifosbuvir Metabolite M5|C24hr is a measure of plasma drug concentration 24 hours after dosing. The C24hr of the M5 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|24 hours post-dose|All participants are included in the analysis.|||nM||95% Confidence Interval|Geometric Least Squares Mean
2560266|NCT02666352|Primary|Cmax of Uprifosbuvir Metabolite M5|Cmax is the maximum observed plasma drug concentration after dosing. The Cmax for the M5 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||nM||95% Confidence Interval|Geometric Least Squares Mean
2561402|NCT02650921|Secondary|Improvement in Hand as Evaluated by IPR|Independent Photographic Reviewer's assessment of improvement (Yes/No)|20 weeks|ITT|||Participants|||Count of Participants
2560267|NCT02666352|Primary|AUC0-24hr of Uprifosbuvir Metabolite M5|AUC0-24hr is a measure of the mean plasma drug concentration from time of dosing to 24 hours post-dose. The AUC0-24hr for the M5 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose|All participants are included in the analysis.|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2560268|NCT02666352|Primary|AUC0-inf of Uprifosbuvir Metabolite M5|AUC0-inf is a measure of the mean plasma drug concentration from time of dosing to infinity. The AUC0-inf for the M5 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2560269|NCT02666352|Primary|AUC0-last of Uprifosbuvir Metabolite M5|AUC0-last is a measure of the mean plasma drug concentration from time of dosing to the last quantifiable sample. The AUC0-last for the M5 metabolite of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2560270|NCT02666352|Primary|Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) of Uprifosbuvir|Vz/F is the apparent volume of distribution during the terminal phase after non-intravenous administration. The Vz/F of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||L||Geometric Coefficient of Variation|Geometric Mean
2560271|NCT02666352|Primary|Apparent Total Clearance From Plasma After Oral Administration (CL/F) of Uprifosbuvir|CL/F is a measure of the apparent rate at which drug is removed from the body via renal, hepatic, and other clearance pathways after oral administration. The CL/F of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2560272|NCT02666352|Primary|Apparent Terminal Half-Life (t1/2) of Uprifosbuvir|t1/2 is a measure of how long it takes to clear 50% of drug after reaching Cmax. The t1/2 for uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||hr||Geometric Coefficient of Variation|Geometric Mean
2560273|NCT02666352|Primary|Time to Reach Cmax (Tmax) of Uprifosbuvir|Tmax is the time required to reach maximum plasma drug concentration (i.e., Cmax). The Tmax for uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||hr||Full Range|Median
2560274|NCT02666352|Primary|Plasma Drug Concentration at 24 Hours (C24hr) of Uprifosbuvir|C24hr is a measure of plasma drug concentration 24 hours after dosing. The C24hr of uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|24 hours post-dose|All participants are included in the analysis.|||nM||Full Range|Median
2560275|NCT02666352|Primary|Maximum Plasma Drug Concentration (Cmax) of Uprifosbuvir|Cmax is the maximum observed plasma drug concentration after dosing. The Cmax for uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||nM||95% Confidence Interval|Geometric Least Squares Mean
2560276|NCT02666352|Primary|Area Under the Plasma Drug Concentration-Time Curve From Start of Dosing to 24 Hours Post-Dose (AUC0-24hr) of Uprifosbuvir|AUC0-24hr is a measure of the mean plasma drug concentration from time of dosing to 24 hours post-dose. The AUC0-24hr for uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose|All participants are included in the analysis.|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2560277|NCT02666352|Primary|Area Under the Drug Plasma Concentration-Time Curve From Start of Dosing to Infinity (AUC0-inf) of Uprifosbuvir|AUC0-inf is a measure of the mean plasma drug concentration from time of dosing to infinity. The AUC0-inf for uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2560278|NCT02666352|Primary|Area Under the Drug Plasma Concentration-Time Curve From Start of Dosing to Time of the Last Quantifiable Sample (AUC0-last) of Uprifosbuvir|AUC0-last is a measure of the mean plasma drug concentration from time of dosing to the last quantifiable sample. The AUC0-last for uprifosbuvir 450 mg (given in combination with ruzasvir 60 mg) was calculated for each arm.|Pre-dose (0), and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||µM*hr||95% Confidence Interval|Geometric Least Squares Mean
2560279|NCT02666222|Secondary|Improvement in Quality of Life as Reflected by Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire|"APHAB results were obtained from baseline aided condition through Year 5 of follow up. The APHAB responses are in terms of percent of time an individual experiences problems, on a scale of 0-100%; lower scores indicate fewer problems.Compared scores with Esteem to scores in baseline aided condition, calculated as APHAB Global score at baseline minus APHAB Global score at Year 5, giving a difference in benefit score. The Global Score is the mean of the scores (% of problems) for Ease of Communication (EC), Reverberation (RV), and Background Noise (BN) subscales of the APHAB. A positive difference in benefit score indicates more benefit with Esteem."|Baseline through Year 5 of Follow Up|5 Year Follow-up|||difference score in units on a scale||Full Range|Mean
2560280|NCT02666222|Primary|Bone Conduction Stability|ENDPOINT #5: Difference between Baseline and 5 Year Pure-Tone Average (PTA; average of 500, 1000, 2000 Hz thresholds); calculated as PTA at Year 5 minus PTA at baseline. Smaller magnitude dB difference indicates better outcome.|Baseline through 5 Year Follow-Up|Difference between Baseline and 5 Year PTA (average of 500, 1000, 2000 Hz thresholds)|||dB||Standard Error|Mean
2560282|NCT02666222|Primary|Change From Baseline (Pre-implant Aided Condition) at Year 5 in Word Recognition Score (WRS) at 50 dB HL|ENDPOINT #2: WRS at Year 5 minus WRS at baseline. Positive difference (in % correct) indicates better outcome.|Baseline through Year 5 of Follow Up|5 Year Follow-up Visit|||percentage of correct responses||Standard Error|Mean
2560283|NCT02666222|Primary|Change From Baseline (Pre-implant Aided Condition) at Year 5 in Speech Reception Threshold (SRT)|ENDPOINT #1: SRT at baseline minus SRT at Year 5. Positive difference (i.e. lower value of SRT with the Esteem) indicates better outcome.|Baseline through Year 5 of Follow Up|5 Year Follow-up|||dB||Standard Error|Mean
2560284|NCT02665689|Secondary|Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment|"All adverse events were documented. Causal relationship to study treatment was assessed by the investigators.~Intended time frame was baseline to 24 months. None of the patients reached time points beyond 12 months due to study discontinuation."|Baseline to 12 months||||participants|||Number
2560285|NCT02665689|Secondary|Number of Participants With Retinal Detachment, Central Retinal Artery Occlusion, or Endophthalmitis and/or Ocular Adverse Events That Are Related to Treatment|All ocular adverse events presented from baseline to 24 months will be documented.|Baseline to 12 months|Patients in study arm A discontinued before month 12. None of the patients reached time points beyond month 12 due to trial discontinuation.|||participants|||Number
2560286|NCT02665689|Secondary|Number of Panretinal Laser Photocoagulation (PRP) Treatments Necessary for Neovascular Complications|"Need for PRP is up to the investigator's decision. Assessment was done on every visit.~Intended time frame was baseline to 24 months. None of the patients reached time points beyond month 12 due to study discontinuation.~Unit of measure is any separate investigator's decision to perform panretinal laser photocoagulation (PRP) for neovascular complications. Each PRP is counted separately."|Baseline to 12 months||||number of PRPs across participants|||Number
2560287|NCT02665689|Secondary|Time to Reach Target HbA1c||24 months|Originally, target HbA1c should have been defined individually for each patient by the investigator acc. to the patient’s general status by risk factors for vasculopathy (Body-Mass-Index, smoking, blood pressure, lipid Status). However, definition of target HbA1c values was waived and only HbA1c values were documented (not shown here).||||||
2560288|NCT02665689|Secondary|Macular Thickness Change at 6, 12, 18 and 24 Months Compared to Baseline|"As the time point 12 months for the evaluation of this secondary endpoint was reached only for patients of study arm B, a comparison of both study arms was not possible and thus analysis of the endpoint was waived completely. None of the patients reached time points beyond month 12 due to trial discontinuation. Results are only shown descriptively.~Macular thickness (study eye) is shown as change in thickness [µm] compared to individual baseline value. A reduction in thickness means improvement."|Baseline to 12 months|For none of the patients in study arm A 12-month data was available. Time points beyond 6 months (18, 24 months) were reached by none of the patients due to trial discontinuation. Results are only shown descriptively.|||µm|||Number
2560289|NCT02665689|Secondary|Difference of Best Corrected Visual Acuity Measured in ETDRS Letters Score Between Month 6, 12, 24 and Baseline Visit|"As the time point 12 months for the evaluation of this secondary endpoint was reached only for patients of study arm B, a comparison of both study arms was not possible and thus analysis of the endpoint was waived completely. Time point 24 months was reached by none of the patients due to trial discontinuation. Results are only shown descriptively.~Best-corrected visual acuity (BCVA) score is shown as change in ETDRS letters score at the distinct time point compared to baseline. Higher scores mean a better outcome."|Baseline to 12 months|BCVA score compared to baseline.|||Letters improved|||Number
2560290|NCT02665689|Secondary|Number of Treatments With Ranibizumab up to 6, 12, 18 and 24 Months of Treatment|"For the number of treatments at 6, 12, 18 and 24 months, an ANOVA without any covariates was planned to be applied at each endpoint 6, 12, 18 and 24 months.~As the time point 12 months for the evaluation of this secondary endpoint was reached only for patients of study arm B, a comparison of both study arms was not possible and thus statistical analysis of the endpoint was waived completely. None of the patients reached time points beyond month 12.~Results are only shown descriptively. Ranibizumab injections were summed up per study arm as well as cumulative at each time point."|Baseline to 12 months|At month 6, the two patients in study arm A had received six treatments each; the two patients in study arm B had received three and five treatments, respectively. At month 12, the two patients in study arm B had received three and six treatments, respectively. For none of the patients in study arm A, 12-month data was available.|||Ranibizumab injections|||Number
2560291|NCT02665689|Primary|Difference of Best Corrected Visual Acuity Measured in ETDRS Letters Score Between Month 12 Baseline Visit|Measured by the difference in ETDRS letters score between month 12 and baseline according to internal guideline of Charité department of ophthalmology.|Baseline to 12 months|Of the four enrolled patients, only the two patients had 12-month visit. Since the time point for the evaluation of the primary endpoint was reached only for patients of study arm B, a comparison of both study arms was not possible and thus analysis of the primary endpoint was waived.||||||
2560292|NCT02665468|Secondary|Physician Accessibility and Engagement|"To explore the impact of secure messaging use on healthcare encounters, the investigators will compare each arm at 6-month follow-up assessment with responses from Health Care Climate Questionnaire (HCCQ), a 15-item scale adapted to assess the degree to which patient healthcare provider is accessible and supportive (taking the participant's perspective, encouraging and answering questions, supporting their plans) This is a Likert scale ranging from 1 = Strongly Disagree to 7 = Strongly Agree; where in all but one question - 1 = Strongly Agree is the desired response. Responses were totaled, inverting the one question and mean was determined."|Six months|Participants who completed 6-month follow-up survey|||units on a scale||Standard Deviation|Mean
2560293|NCT02665468|Secondary|Care Coordination: Patient Assessment of Chronic Illness Care|To explore the impact of secure messaging use on healthcare encounters, the investigators will use the Patient Assessment of Chronic Illness Care (PACIC) designed to assess patients' perceptions of the degree to which their care experiences are consistent with the chronic care model and includes subscale scores for patient activation, goal setting/tailoring, and follow-up/coordination. Investigators compared arms at 6-month follow-up using scale 0 (not a problem) - 4 (very big problem), where 0 indicates the desired response.|Six month follow-up|Participants who completed 6-month follow-up assessment|||units on a scale||Standard Deviation|Mean
2561403|NCT02650921|Secondary|Improvement in Hand as Evaluated by IPR|Independent Photographic Reviewer's assessment of improvement (Yes/No)|16 weeks|ITT|||Participants|||Count of Participants
2560294|NCT02665468|Secondary|Patient Self-reported Access to Communication|"To explore the impact of secure messaging use on healthcare encounters, the investigators will compare the responses of each arm at 6-month follow-up assessment for Patient Self-reported Access to communication using 2 Questions adapted from the Survey of Healthcare Experience of Patients Scale which inquires, How easy is it for you to communicate with your doctor when you need to? and, How easy is it for you to get to see your nurse when you need to? Responses to scale were 1= Never, 2= Sometimes, 3= Usually, 4= Always; where Always was the best score."|Six month follow-up|Participants who completed the 6-month follow-up survey|||units on a scale||Standard Deviation|Mean
2560295|NCT02665468|Primary|Change in Rate of Use|Measure the change in rate of use of secure messaging in intervention versus control Veterans, reported as participants in each arm that sent a secure message during study period.|Baseline and Six months|The number of participants who received the Supported Adoption Intervention as analyzed was 2 less (these materials were returned/wrong address) than initially randomized and baseline characteristics are presented for.|||Participants|||Count of Participants
2560296|NCT02665455|Primary|Point Accuracy Determined as % Within Consensus Error Grid Zone A|"Point accuracy of Sensor based glucose values versus fingerstick blood glucose determined as % within Consensus Error Grid zone A.~Zone A is defined as the zone of clinical accurate measurements with no effect on clinical action."|14 days||||percentage of results||95% Confidence Interval|Number
2560297|NCT02665364|Post-Hoc|Number of Participants Who Achieved a Composite SRI-4 (CS ≤7.5mg/Day) Excluding IFN-K Subjects Without Positive Anti-IFNalpha Neutralizing Antibodies at Week 36|participant who had the following criteria defined as : SRI-4 plus CS ≤7.5mg/day -excluding IFN-K Patients without positive anti-IFN-alpha neutralizing antibodies|At week 36|A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 72 had a Composite SRI-4 (CS ≤7.5mg/day) at Week 36 visit. 93 subjects received placebo, among them, 77 had a Composite SRI-4 (CS ≤7.5mg/day) at Week 36 visit.|||Participants|||Count of Participants
2560298|NCT02665364|Post-Hoc|Number of Participants Who Achieved a Composite SRI-4 (CS ≤5mg/Day) Excluding IFN-K Subjects Without Positive Anti-IFNalpha Neutralizing Antibodies at Week 36|Subjects who had the following criteria defined as : SRI-4 plus CS ≤5mg/day -excluding IFN-K subjects without positive anti-IFN-alpha neutralizing antibodies|At week 36|A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 72 had a Composite SRI-4 (CS ≤5mg/day) at Week 36 visit. 93 subjects received placebo, among them, 77 had a Composite SRI-4 CS ≤5mg/day at Week 36 visit.|||Participants|||Count of Participants
2560299|NCT02665364|Other Pre-specified|CS Mean Daily Dose at W36|mean daily dose of corticosteroid (CS) (prednisone equivalent)|At W36||||mg/day||Standard Error|Mean
2560300|NCT02665364|Secondary|Number of Participants With Treatment-related Adverse Events|Number of participants who reported any treatment-related adverse events until month 9|9 months||||Participants|||Count of Participants
2560301|NCT02665364|Secondary|Number of Participants With Neutralizing Anti-IFN-alpha Antibodies at W36|Individual serum antibody neutralizing capacity against recombinant IFN-alpha2b was measured by reporter gene assay using Interferon Sensitive Response Element (ISRE) reporter.|At week 36|"91 subjects received IFN-K, among them, 79 were positive for Anti-IFN-alpha antibodies at Week 36 visit.~No Neutralizing Anti-IFN-alpha antibodies were performed on placebo subjects."|||Participants|||Count of Participants
2560302|NCT02665364|Secondary|Number of Participants Who Achieved a Composite SRI-4 Including CS ≤5mg/Day at Week 36|"SRI-4 plus CS ≤ 5mg/day responder was defined as a participant who had the following criteria at Week 36:~reduction ≥4 points in SELENA-SLEDAI at week 36 compared with baseline, and~no new BILAG A at week 36, and~no more than 1 new BILAG B at week 36, and~no deterioration in PGA (<10% worsening) on 100-mm VAS compared with baseline plus corticosteroids (CS) ≤5mg equivalent prednisolone per day at week 36"|At Week 36|A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 79 had CS ≤5mg/day at Week 36 visit. 93 subjects received placebo, among them, 77 had CS ≤5mg/day at Week 36 visit.|||Participants|||Count of Participants
2560303|NCT02665364|Secondary|Number of Participants Who Achieved a Composite SRI-4 Including CS ≤7,5mg/Day at Week 36|"SRI (4) plus CS ≤ 7.5 mg/day responder was defined as a participant who had the following criteria at week 36:~reduction ≥4 points in SELENA-SLEDAI at week 36 compared with baseline, and~no new BILAG A at week 36, and~no more than 1 new BILAG B at week 36, and~no deterioration in PGA (<10% worsening) on 100-mm VAS compared with baseline plus CS ≤7.5mg equivalent prednisolone per day at week 36"|At Week 36|A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 79 had CS ≤7,5mg/day at Week 36 visit. 93 subjects received placebo, among them, 77 had CS ≤7,5mg/day at Week 36 visit.|||Participants|||Count of Participants
2560304|NCT02665364|Secondary|CLASI Total Activity Change From Baseline at Week 36|Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) was specifically developed to assess the cutaneous manifestations of SLE. It measures both disease activity and permanent damage (e.g. dyspigmentation and scarring) over the entire body surface. CLASI total activity score ranges from 0 to 70, with higher scores indicating more severe skin disease.|Baseline and Week 36||||scores on a scale||Standard Deviation|Mean
2560305|NCT02665364|Secondary|SLICC/ACR-DI Change From Baseline at Week 36|Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index for systemic lupus erythematosus (SLICC/ACR-DI) captures permanent changes which have occurred in patients with SLE, regardless of causality. The questionnaire contains 41 items covering 12 different organ systems. The score of items ranges from 1 to 3 and the total score from 0 to 47. By definition score 0 corresponds to diagnostics and damage over time can only be stable or increase, theoretically to a maximum of 47 points.|Baseline and Week 36|A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 82 completed SLICC/ACR/DI questionnaire at Week 36 visit. 93 subjects received placebo, among them, 83 completed Week 36 visit.|||scores on a scale||Standard Deviation|Mean
2560318|NCT02665221|Other Pre-specified|Flu-like Symptom Scale at Last Visit Compared to Base Line.|Study was terminated. No data analyzed because the Logpad being used by subjects was flawed.|6 Hours|Study was terminated. Logpad used by subjects was defective and data was not collected. No data analyzed.||||||
2560574|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as Fair"||Up to 72 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
2560306|NCT02665364|Secondary|SELENA-SLEDAI - Change From Baseline to Week 36|Safety of Estrogens in Systemic Lupus Erythematosus National Assessment (SELENA)-SLEDAI, is a slightly modified version of the SLEDAI. This is a weighted index in which signs and symptoms, laboratory tests, and Physician's Global Assessment (PGA) for each of nine organ systems are given a weighted score and summed up if present at the time of the visit or in the preceding 10 days. The maximum theoretical score for the SELENA SLEDAI is 105 (all 24 descriptors present simultaneously) with 0 indicating inactive disease.|Baseline and Week 36|A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 84 completed Week 36 visit. 93 subjects received placebo, among them, 83 completed Week 36 visit.|||SELENA SLEDAI Score||Standard Deviation|Mean
2560307|NCT02665364|Secondary|BILAG Global Score Change From Baseline to Last Available Value (LVA) Between Week 24 and Week 36|"British Isles Lupus Assessment Group (BILAG)-2004 index, it categorizes disease activity into 5 different levels from A to E, with Grade A representing very active disease and Grade E indicating no current or previous disease activity. Scoring was based on a total of 101 items, grouped into 9 organ/systems and the summation of the numerical values for the nine-system scores was given by the following formula: Numerical global score = A*12 + B*8 + C*1, where A, B and C represent the number of Grades A, B and C respectively at each assessment. Grades D and E are considered as 0 (Chee-Seng Yee et al, 2010). The minimum score is 0 with no predefined maximum. The higher scores mean a worse outcome.~The BILAG global score change from baseline to Last Available Value (LVA) week 24 and week 36 were presented analyzed."|Last Available Value (LVA) between week 24 and week 36|A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 87 had a Last available value (LAV) between Week 24 and Week 36 analyzed. 93 subjects received placebo, among them, 84 had LAV between Week 24 and Week 36 analyzed.|||scores on a scale||Standard Deviation|Mean
2560308|NCT02665364|Secondary|Number of Participants Who Achieved a Lupus Low Disease Activity State (LLDAS) at Week 36|"Lupus low disease activity state (LLDAS) was conceptually defined as 'a state which, if sustained, is associated with a low likelihood of adverse outcome, considering disease activity and medication safety'. Subsequently defined using consensus methodology, LLDAS is attained if all the following items are met:~SLEDAI-2K ≤4, with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity~No new features of lupus disease activity compared with the previous assessment~SELENA-SLEDAI physician global assessment (PGA, scale 0-3) ≤1~Current prednisolone (or equivalent) dose ≤7.5 mg daily~Well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents, excluding investigational drugs"|At Week 36||||Participants|||Count of Participants
2560309|NCT02665364|Secondary|Number of Participants Who Achieved a Systematic Lupus Erythematosus (SLE) Responder Index (SRI)-4 at Week 36|"SLE Responder Index (SRI); SRI-4 responder was defined as a subject who had the following criteria at week 36:~reduction ≥4 points in SELENA-SLEDAI at week 36 compared with baseline, and~no new BILAG A at week 36, and~no more than 1 new BILAG B at week 36, and~no deterioration in PGA (<10% worsening) on 100-mm VAS compared with baseline"|W36 (9 months)|A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 84 completed Week 36 visit. 93 subjects received placebo, among them, 83 completed Week 36 visit.|||Participants|||Count of Participants
2560310|NCT02665364|Primary|Number of Participants Who Achieved a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) With Superimposed CS Tapering at Week 36|"British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) responder was defined as a subject who had the following criteria at week 36:~All BILAG A scores at baseline improve to B/C/D and all BILAG B scores improve to C/D at W36, and~No BILAG worsening in other body systems: no new BILAG A or ≥ 2 new BILAG B scores at W36, and~No worsening in SLEDAI-2K total score at W36 compared with baseline, and~No deterioration in Physician Global Assessment (PGA) (< 10% worsening) on Visual Analog Scale (VAS) 100 mm at W36 compared with baseline, and~No addition or increased dose level of anti-malarial drugs or immunosuppressive drugs or CS* between W24 and W36 (*≤5 mg prednisolone or equivalent /day at W24 and no increase until W36)."|At Week 36|A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 85 completed Week 36 visit. 93 subjects received placebo, among them, 84 completed Week 36 visit.|||Participants|||Count of Participants
2560311|NCT02665364|Primary|Percent Change From Baseline in IFN Gene Signature at W36|The biological endpoint aimed at evaluating the neutralization of the IFN gene signature following treatment with IFN-K compared to placebo, as measured by the % change from baseline of the expression of IFN-induced genes.|Baseline and Last Available Value (LVA) between week 24 and week 36|A total of 185 subjects were randomized and 184 were treated. 91 subjects received IFN-K, among them, 87 had a Last available value (LAV) between Week 24 and Week 36 analyzed. 93 subjects received placebo, among them, 84 had LAV between Week 24 and Week 36 analyzed.|||percent change||Standard Deviation|Mean
2560312|NCT02665286|Secondary|Patient Satisfaction With Treatment|The number of participants with affirmative response to the following question: Do you want the same medication combination during a subsequent episode of LBP. This is a patient-centered outcome that allows each individual to determine the desirability of the intervention.|1 week||||Participants|||Count of Participants
2560313|NCT02665286|Secondary|Medications--Patient Self Report of Medication Use|Participants still using medication such as analgesics for LBP after treatment|1 week||||Participants|||Count of Participants
2560314|NCT02665286|Secondary|Cases of Moderate or Severe LBP|Participants with moderate to severe low back pain after treatment as report on the following ordinal scale: severe, moderate, mild, or none|1 week||||Participants|||Count of Participants
2560315|NCT02665286|Primary|Functional Impairment as Measured on the Roland Morris Disability Questionnaire|"Change in Roland Morris Disability Questionnaire between baseline and 1 week.~The low back pain functional disability scale is the RMDQ. The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment."|1 week||||units on a scale||95% Confidence Interval|Mean
2560316|NCT02665260|Secondary|Number of Subjects Who Experienced an Adverse Event|Number of subjects who experienced an adverse event as assessed by patient-reported outcomes questionnaire at each visit|33 weeks||||Participants|||Count of Participants
2560317|NCT02665260|Primary|Number of Subjects Who Achieve Complete Clearance at 6 Weeks|Assess number of subjects who achieve a lesion count of zero at 6 weeks (end of open-label phase)|6 weeks||||Participants|||Count of Participants
2560319|NCT02665221|Secondary|Number of Patients Experiencing Injection Site Reaction Erythema, Itching and Pain.|Study was terminated. No data analyzed. Study was terminated. No data analyzed because the Logpad being used by subjects was flawed.|6 Hours|Study was terminated. No data analyzed. Study was terminated. No data analyzed because the Logpad being used by subjects was flawed.||||||
2560320|NCT02665221|Secondary|Width of Injection Site Erythema in Millimeters 6 hr After Application of Preparation H to First Injection Site Erythema Compared to Baseline Width of Injection Site Erythema at Least 2 Hours After Injection.|Study was terminated. No data analyzed|6 Hours|Study was terminated. Logpad used by subjects was defective and data was not collected. No data analyzed.||||||
2560321|NCT02665221|Primary|Patient Erythema Self-Assessment (PSA) Score 6 hr After Application of Preparation H to First Injection Site Erythema Compared to Baseline PSA Score of Injection Site Erythema at Least 2 Hours After PLEGRIDY Injection.||6 Hours|Study was terminated. Logpad used by subjects was defective and data was not collected. No data analyzed.||||||
2560322|NCT02664987|Secondary|Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale|"The Eastern Cooperative Oncology Group Performance Status (ECOG PS) scale ranges from 0 to 4:~0- Fully active, able to carry on all pre-disease performance without restriction~Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work~Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours~Capable of only limited self-care, confined to bed or chair more than 50% of waking hours~Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair~A higher score indicates greater functional impairment."|Day 1||||percentage of patients|||Number
2560323|NCT02664987|Secondary|Sleep Disturbance Within Last 7 Days Assessed Using Questionnaire Answered by Patient|"Patients answered yes or no to the following question:~Have you had trouble sleeping due to your cancer pain within the last 7 days?"|Past 7 days up to Day 1||||percentage of patients|||Number
2560324|NCT02664987|Primary|Intensity of Pain Currently and Over Past 24 Hours as Measured by NRS Scores Indicated by Patient|"Patients indicated their pain intensity using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).~Their current pain intensity and pain in the last 24 hours were indicated on separate scales. A higher score indicates higher pain intensity."|Past 1 day up to Day 1||||units on a scale||Standard Deviation|Mean
2560325|NCT02664987|Primary|Quality of Life as Measured Using EQ-5D-3L Questionnaire Answered by Patient|EQ-5D-3L summary indices were calculated using the algorithm developed based on the valuation of EQ-5D-3L health states from an adult Thai population (Tongsiri & Cairns, 2011). Applying the Thai algorithm, EQ-5D-3L summary indices range from -0.45 to 0.80, with an EQ-5D-3L summary index of 0.80 indicating the best overall health-related quality of life.|Day 1||||units on a scale||Standard Deviation|Mean
2560326|NCT02664987|Primary|Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators|"The scale used to measure a patient's satisfaction with pain control ranges from 1 to 5:~Very satisfied~Satisfied~Acceptable~Dissatisfied~Very dissatisfied~Patients and Investigators will each indicate their opinion on separate scales."|Day 1||||percentage of patients|||Number
2560327|NCT02664987|Primary|Prescription Pattern of Analgesics (Opioid or Non-opioid)|At Visit 1 (Day 1) which was the only visit in the study, data was collected on whether each patient was receiving only opioid, only non-opioid or both opioid and non-opioid analgesic treatments for pain control.|Day 1||||percentage of patients||95% Confidence Interval|Number
2560328|NCT02664961|Secondary|Frequency and Severity of Adverse Events|Determine frequency and severity of adverse events as assessed by NCI CTCAE (Version 4.03)|20 months||||Participants|||Count of Participants
2560329|NCT02664961|Secondary|TRC105 Immunogenicity as Assessed by Anti-Product Antibody (APA).|Anti-Product Antibody (APA) concentrations will be measured using validated ELISA methods at the time points specified in the protocol. APA concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles. Number of patients with positive APA titers on study will be reported.|8 weeks||||Participants|||Count of Participants
2560330|NCT02664961|Secondary|Maximum Plasma Concentration (Cmax) of TRC105.|Mean serum TRC105 concentrations were assessed at cycle 1 and cycle 2 on day 1, 8, 15, and 22 and on day 1 of every subsequent cycle using validated methods in order to determine the Cmax of TRC105|cycle 2 day 1 (28 days after initiation of dosing)||||ng/mL||Full Range|Mean
2560331|NCT02664961|Secondary|Overall Response Rate on Bevacizumab Alone|Overall Response Rate on bevacizumab alone according to RECIST 1.1 in combination with serum hCG levels. Disease progression is defined as >20% increase (the absolute increase must be ≥10 IU/L) above the nadir on consecutive measurements separated by at least two weeks; Partial response is defined as a hCG decrease of 50% or more from starting value on consecutive measurements; Complete response will be defined as normalization of hCG on consecutive measurements separated by at least two weeks; Stable disease will be defined as the absence of response or progression on 3 consecutive measurements separated by at least two weeks.|8 weeks|No patients received bevacizumab alone.||||||
2560332|NCT02664961|Secondary|Progression-Free Survival (PFS)|Median Progression-Free Survival (PFS) via Serum hCG levels and response evaluation according to RECIST version 1.1 as a preliminary measure of the antitumor activity of TRC105. Disease progression is defined as >20% increase (the absolute increase must be ≥10 IU/L) above the nadir on consecutive measurements separated by at least two weeks; Partial response is defined as a hCG decrease of 50% or more from starting value on consecutive measurements; Complete response will be defined as normalization of hCG on consecutive measurements separated by at least two weeks; Stable disease will be defined as the absence of response or progression on 3 consecutive measurements separated by at least two weeks. Patients must have screening (baseline) and at least one on study CT scan to be considered evaluable.|8 weeks|Progression Free Survival|||weeks||Full Range|Median
2560352|NCT02664311|Secondary|Fluoroscopy Time|Fluoro time as recorded by RNs from Xray machine|Immediate post-procedure||||minutes||Standard Deviation|Mean
2560353|NCT02664311|Secondary|Freedom From AF||1 year||||Participants|||Count of Participants
2560354|NCT02664311|Primary|Isolation Time|Comparison of Time (in Minutes) From Obtaining Access to Left Atrium Via Transseptal Catheterization to Demonstrated Isolation of All Pulmonary Veins - hypothesis is that with Jet ventilation there will be a shorter time to pulmonary vein isolation in comparison to conventional ventilation|Immediate post procedure||||minutes||Standard Deviation|Mean
2560333|NCT02664961|Primary|Overall Response Rate on TRC105 Alone and on the Combination of TRC105 and Bevacizumab|Antitumor Activity of Single Agent TRC105 and the Combination of TRC105 and Bevacizumab will be assessed via RECIST 1.1 and by measuring circulating bHCG. Disease progression is defined as >20% increase (the absolute increase must be ≥10 IU/L) above the nadir on consecutive measurements separated by at least two weeks; Partial response is defined as a hCG decrease of 50% or more from starting value on consecutive measurements; Complete response will be defined as normalization of hCG on consecutive measurements separated by at least two weeks; Stable disease will be defined as the absence of response or progression on 3 consecutive measurements separated by at least two weeks.|8 weeks|All patients who had a baseline scan and at least 1 on study assessment|||Participants|||Count of Participants
2560334|NCT02664610|Secondary|Mean Change in Diastolic Blood Pressure||Baseline to 6 months||||mmHg||Standard Deviation|Mean
2560335|NCT02664610|Primary|Mean Change in Systolic Blood Pressure||Baseline to 6 months||||mmHg||Standard Deviation|Mean
2560336|NCT02664532|Secondary|Total Laryngoscopy Duration in Seconds|The duration of intubation was defined as the time taken from placement of the laryngoscope in the mouth to the time taken to remove the laryngoscope from the mouth following intubation.|180 seconds||||Seconds||Standard Deviation|Mean
2560337|NCT02664532|Secondary|Number of Intubation Attempts|"An intubation attempt is defined as intubation activities occurring during a single continuous laryngoscopy maneuver. Thus, even if several attempts were made to place an endotracheal tube during the course of a single laryngoscopy, this would be counted as a single intubation attempt."|180 seconds||||participants|||Number
2560338|NCT02664532|Secondary|Cormack Lehane Grading|Grade 1 Full view of glottis Grade 2 Only posterior commissure visible Grade 3 Only epiglottis visible Grade 4 No glottis structure visible|60 seconds||||participants|||Number
2560339|NCT02664532|Primary|Ease of Intubation or Degree of Difficulty With Intubation|Degree of difficulty with intubation Grade 1 Intubation easy Grade 2 Intubation requiring an increased anterior lifting force/optimal external laryngeal manipulation (OELM)/assistance to pull the right corner of the mouth upwards to augment space Grade 3 Intubation requiring more than one attempt or bougie guided intubation Grade 4 failure to intubate with the assigned laryngoscope|60 seconds||||participants|||Number
2560340|NCT02664415|Secondary|Computed Score on the Control and Attention Task (i.e., Flanker Task)|The Flanker is a measure of executive function, specifically tapping inhibitory control and attention.The scores range from 0 to 10. A higher scores indicate higher levels of ability to attend to relevant stimuli and inhibit attention from irrelevant stimuli.|Measured from Baseline ATI through ART resumption.|Participants who received at least 1 full dose of VRC01 or Placebo and underwent ATI.|||score||Full Range|Median
2560341|NCT02664415|Secondary|Neuropsychological Battery Performance|This is a NPZ-4 score,a 4-test NP battery evaluated fine motor function/manual dexterity [Grooved Pegboard test (GP), non-dominant hand], psychomotor speed [Color Trails 1 (CT1), Trail Making A (TM)], and executive function/set shifting [Color Trails 2 (CT2)]. Individual test raw scores were converted to z-scores. Z-scores range from -3 standard deviations up to +3 standard deviations. Higher scores indicate better test performance and lower cognitive impairment.|Measured from Baseline ATI through ART resumption.|Participants who received at least one full dose of VRC01 or Placebo and underwent ATI.|||Z-score||Full Range|Median
2560342|NCT02664415|Secondary|Number of Participants With Acute Retroviral Syndrome (ARS)|This is the number of participants who have developed during ATI.|Measured from Baseline ATI through ART resumption.|Participants who received at least one full dose of VRC01 or Placebo and underwent treatment interruption.|||Participants|||Count of Participants
2560343|NCT02664415|Secondary|Number of Participants Hospitalized.|Participants were monitored for up to 10 weeks after the last infusion of VRC01 or placebo|Measured up to 10 weeks after the last infusion of VRC01 or placebo|Participants who have been randomized to receive VRC01 or Placebo.|||Participants|||Count of Participants
2560344|NCT02664415|Secondary|Total HIV DNA in the Peripheral Compartment|This is total HIV DNA levels at baseline ATI, ART resumption and 6 month after ART resumption|Measured from ATI through 6 months after ART resumption|Participants who received at least 1 full dose of VRC01 or Placebo and underwent ATI.|||copies/10^6 CD4 T cells||Full Range|Median
2560345|NCT02664415|Secondary|Change in CD4+ T Cell Count From ATI to ART Resumption|This is change in CD4+ T cell count from ATI to ART resumption.|Measured from Baseline ATI through ART resumption|Participants who received at least 1 full dose of VRC01 or Placebo and underwent ATI.|||cells/mm^3||Full Range|Median
2560346|NCT02664415|Secondary|Number of Participants With Detectable HIV-1 RNA Via Single Copy Assay|This is number of participants who had detectable HIV-1 RNA via the ultrasensitive single copy assay prior to detectability on the routine assay.|Measured from Baseline ATI through ART resumption.|Participants who received at least 1 full dose of VRC01 or Placebo and underwent ATI.|||Participants|||Count of Participants
2560347|NCT02664415|Secondary|Time to ART Resumption for Any Reason After Cessation of ART|This is the days from ATI to ART resumptions.|Measured from Baseline ATI through ART resumption.|Participants who received at least one full dose of VRC01 or placebo and underwent ATI.|||days||Full Range|Median
2560348|NCT02664415|Secondary|Level of Rebound Viremia After Cessation of ART|This is the HIV-1 RNA levels (copies/mL) at first detection and ART resumption.|Measured from Baseline ATI through ART resumption.|Participants who received at least 1 full dose of VRC01 or Placebo and underwent ATI.|||copies/mL||Full Range|Median
2560349|NCT02664415|Secondary|Time to Viral Rebound After Cessation of ART|"This is the days from Analytic Treatment Interruption (ATI) to:~HIV RNA >= 20 copies/mL.~HIV RNA >= 1000 copies/mL"|Measured from Baseline ATI through ART resumption.|Participants who received at least 1 full dose of VRC01 or Placebo and underwent ATI.|||days||Full Range|Median
2560350|NCT02664415|Primary|Number of Participants With Sustained Virologic Suppression|Number of participants who sustained virologic control (HIV RNA <50 copies/mL), without indication for ART resumption at week 24.|Measured through 24 weeks after ATI|This is the number of participants who received at least one full dose of VRC01 or placbo, underwent Analytic Treatment Interruption (ATI).|||Participants|||Count of Participants
2560351|NCT02664415|Primary|Number of Participants With Serious Adverse Event|Participants were monitored for up to 10 weeks after the last infusion of VRC01 or placebo|Measured up to 10 weeks after last infusion of VRC01 or placebo|Participants who were randomized to receive VRC01 or placebo.|||Participants|||Count of Participants
2560357|NCT02664272|Primary|Mean Difference D Between the Position of the Last Trial Rasp and the Final Implant Position of the SL-PLUS™ MIA Ti/HA Femoral Hip Stem as Measured by an Intraoperative Fluoroscopic Measurement|"Difference D was measured using standardized fluoroscopic images taken during surgery. Investigators also reported any stem position corrections made as well as type of rasping instrument used.~The difference D is given in millimeters (mm) and is defined as D = x1 - x2 with x1 being the distance between the shoulder of the trial rasp and the tip of the greater trochanter and x2 being the distance between the shoulder of the implant and the tip of the greater trochanter."|Intraoperative examination only||||mm|hips|95% Confidence Interval|Mean
2560358|NCT02664220|Secondary|Number of Participants Who Visited the Emergency Room|Whether or not a patient visited the emergency room for care directly related to the operation within 30 days after the operation will be determined through chart review, clinical encounters, and phone calls.|30 days post surgery||||Participants|||Count of Participants
2560359|NCT02664220|Secondary|Number of Participants Who Were Readmitted to the Hospital|Whether or not a patient was readmitted to the hospital within 30 days after the operation will be determined through chart review, clinical encounters, and phone calls.|30 days post surgery||||Participants|||Count of Participants
2560360|NCT02664220|Secondary|Total Hospital Length of Stay|Total hospital length of stay will be the aggregate of all days in the hospital including any appendicitis-related readmissions within 30 postoperative days.|30 days post surgery||||days||Standard Deviation|Mean
2560361|NCT02664220|Primary|Number of Participants With Postoperative Intra-abdominal Abscess|30 days postoperative intra-abdominal abscess was confirmed by an image using a standardized definition and protocol|30 days post surgery||||Participants|||Count of Participants
2560362|NCT02663817|Primary|Percent Change in Radiation Dose to Healthy Human Tissue.|The study is computational in nature. A new treatment planning paradigm is proposed, where from the newly proposed treatment plans, and the treatment plans generated with the standard of care, radiation doses to different organs and tissues would be derived. Radiotherapy toxicity (to healthy human tissue) is proportional to radiation dose - more radiation dose results in higher toxicity. Thereby, if radiation dose is decreased, the toxicity would also be decreased. The dosimetric differences which the investigators observe between the standard of care and their novel optimization approach are reported as percent change with respect to the standard of care.|Baseline, up to three years.|Two participants with prostate cancer were screen failures.|||Percent change in radiation dose||Full Range|Mean
2560363|NCT02663752|Secondary|Changes in Transferrin Saturation Levels|From baseline to time of response (responder group) or time to last follow up (non-responders)|Baseline, 18 months|There was no treatment administration specific to this study. The trial was terminated due to low enrollment. Because of the limited number of data collected an efficacy analysis was not possible.||||||
2560364|NCT02663752|Secondary|Changes in Serum Transferrin Levels|From baseline to time of response (responder group) or time to last follow up (non-responders)|Baseline, 18 months|There was no treatment administration specific to this study. The trial was terminated due to low enrollment. Because of the limited number of data collected an efficacy analysis was not possible.||||||
2560365|NCT02663752|Secondary|Deferasirox Dose Used|Deferasirox dose is defined as the average daily dose (mg/kg/d) given to the patient from treatment initiation to the emergence of hematological response in the responder group or the time of enrollment in the study in the non-responder group.|18 months|There was no treatment administration specific to this study. The trial was terminated due to low enrollment. Because of the limited number of data collected an efficacy analysis was not possible.||||||
2560366|NCT02663752|Secondary|Changes in Serum Ferritin Levels|From baseline to time of response (responder group) or time to last follow up (non-responders)|Baseline, 18 months|There was no treatment administration specific to this study. The trial was terminated due to low enrollment. Because of the limited number of data collected an efficacy analysis was not possible.||||||
2560367|NCT02663752|Secondary|Time to Response|The time to response is defined as the time (in months) between the date of deferasirox initiation and the date of the first documented hematological response only in the responder group.|18 months|There was no treatment administration specific to this study. The trial was terminated due to low enrollment. Because of the limited number of data collected an efficacy analysis was not possible.||||||
2560368|NCT02663752|Primary|Fold Increase/Decrease in Gene Transcription From Baseline Bone Marrow Aspirate of Responders Versus Non-responders'|Using next-generation sequencing, gene expression profiling in responder and non-responder patients were to be performed on existing bone marrow aspirate samples. Gene transcription were then to be compared between the two groups and the fold increase/decrease in differentially expressed genes were to be calculated.|18 months|There was no treatment administration specific to this study. The trial was terminated due to low enrollment. Because of the limited number of data collected an efficacy analysis was not possible.||||||
2560369|NCT02663687|Secondary|Volume of Distribution Influenced by Fraction of Dose Absorbed (Vz/F) Following Extravascular Administration of SHP623|Vz/F is the volume of distribution associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed for subcutaneous (SC) administration. Vz/F of SHP623 (rC1 INH) were calculated from observed concentration-versus-time data. The unit of measure is unit per microgram per milliliter [U/(mcg/ml)].|Pre-dose, 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216, 312, 648 hours post-dose.|PK set consisted of all participants in the safety analysis set for whom the primary PK data were considered sufficient and interpretable.|||U/(mcg/ml)||Standard Deviation|Mean
2560370|NCT02663687|Secondary|Total Body Clearance for Extravascular Administration (CL/F) of SHP623 for Subcutaneous (SC) Administration|CL/F is the total body clearance for extravascular administration of SHP623 for SC administration divided by the fraction of dose absorbed. CL/F of SHP623 (rC1 INH) was calculated based on observed concentration-versus-time data. The unit of measure is unit per hour*microgram per milliliter [U/(hr*mcg/ml)].|Pre-dose, 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216, 312, 648 hours post-dose.|PK set consisted of all participants in the safety analysis set for whom the primary PK data were considered sufficient and interpretable.|||U/(hr*mcg/ml)||Standard Deviation|Mean
2560575|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as Poor"||Up to 72 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
2560371|NCT02663687|Secondary|Volume of Distribution Associated With the Terminal Slope (Vz) Following Intravenous (IV) Administration of SHP623|Vz is the volume of distribution associated with the terminal slope following IV administration. Vz was calculated for SHP 623 (rC1 INH) antigen from observed concentration-versus-time data. The unit of measure is unit per microgram per milliliter [U/(mcg/ml)].|Pre-dose, 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216, 312, 648 hours post-dose.|PK set consisted of all participants in the safety analysis set for whom the primary PK data were considered sufficient and interpretable.|||U/(mcg/ml)||Standard Deviation|Mean
2560372|NCT02663687|Secondary|Total Body Clearance (CL) for Intravascular (IV) Administration of SHP623|CL is the total body clearance of SHP623 for IV administration. The unit of measurement is unit per hour*microgram per milliliter [U/(hr*mcg/ml)].|Pre-dose, 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216, 312, 648 hours post-dose.|PK set consisted of all participants in the safety analysis set for whom the primary PK data were considered sufficient and interpretable.|||U/(hr*mcg/ml)||Standard Deviation|Mean
2560373|NCT02663687|Secondary|Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of SHP623|AUClast is the area under the curve from the time 0 to the last measurable concentration of SHP623 (rC1 INH), which was calculated from observed concentration-versus-time data. AUClast of SHP623 for both treatment period 1 (IV) and treatment period 2 (SC) was presented in the categories for each dosing group. The unit of measure is hour*microgram per milliliter (hr*mcg/ml).|Pre-dose, 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216, 312, 648 hours post-dose.|PK set consisted of all participants in the safety analysis set for whom the primary PK data were considered sufficient and interpretable.|||hr*mcg/ml||Standard Deviation|Mean
2560374|NCT02663687|Secondary|Area Under the Plasma Concentration Curve From Time Zero to 168 Hours Postdose (AUC 0-168) of SHP623|AUC 0-168 is the area under the concentration curve over the interval from 0 to 168 hours after dosing of SHP623. AUC 0-168 of SHP623 (rC1 INH) was calculated based on observed concentration-versus-time data. AUC 0-168 of SHP623 for both treatment period 1 (IV) and treatment period 2 (SC) was presented in the categories for each dosing group. The unit of measure is hour*microgram per milliliter (hr*mcg/ml).|Pre-dose, 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216, 312, 648 hours post-dose.|PK set consisted of all participants in the safety analysis set for whom the primary PK data were considered sufficient and interpretable.|||hr*mcg/ml||Standard Deviation|Mean
2560375|NCT02663687|Secondary|Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC 0-inf) of SHP623|AUC 0-inf is the area under the curve extrapolated to infinity, calculated using the observed value of the last non-zero concentration. AUC 0-inf of SHP623 (rC1 INH) antigen was calculated from observed concentration-versus-time data. AUC 0-inf of SHP623 for both treatment period 1 (IV) and treatment period 2 (SC) was presented in the categories for each dosing group. The unit of measure is hour*microgram per milliliter (hr*mcg/ml).|Pre-dose, 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216, 312, 648 hours post-dose.|PK set consisted of all participants in the safety analysis set for whom the primary PK data were considered sufficient and interpretable.|||hr*mcg/ml||Standard Deviation|Mean
2560376|NCT02663687|Secondary|Terminal Half-life (t1/2) of SHP623|t1/2 is the time required for the concentration of the drug to reach half of its original value. t1/2 of SHP623 (rC1 INH) antigen for both treatment period 1 (IV) and treatment period 2 (SC) was presented in the categories for each dosing group.|Pre-dose, 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216, 312, 648 hours post-dose.|PK set consisted of all participants in the safety analysis set for whom the primary PK data were considered sufficient and interpretable.|||hour (h)||Full Range|Median
2560377|NCT02663687|Secondary|Time of Maximum Plasma Concentration (Tmax) of SHP623 Sampled During a Dosing Interval|Tmax of SHP623 (rC1 INH) antigen was calculated based on observed concentration-versus-time data. Tmax of SHP623 for both treatment period 1 (IV) and treatment period 2 (SC) was presented in the categories for each dosing group.|Pre-dose, 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216, 312, 648 hours post-dose.|PK set consisted of all participants in the safety analysis set for whom the primary PK data were considered sufficient and interpretable.|||hour (h)||Full Range|Median
2560378|NCT02663687|Secondary|Maximum Observed Plasma Concentration (Cmax) of SHP623 Occurring at Time of Maximum Observed Concentration During a Dosing Interval (Tmax)|Cmax of SHP623 recombinant human C1 esterase inhibitor (rC1 INH) antigen at Tmax was calculated based on observed concentration-versus-time data. Cmax at Tmax of SHP623 for both treatment period 1 (IV) and treatment period 2 (SC) was presented in the categories for each dosing group.|Pre-dose, 0, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 216, 312, 648 hours post-dose.|Pharmacokinetic (PK) set consisted of all participants in the safety analysis set for whom the primary PK data were considered sufficient and interpretable.|||microgram per milliliter (mcg/ml)||Standard Deviation|Mean
2560379|NCT02663687|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs ) Including Serious Adverse Events (SAEs)|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE was considered to be a TEAE in a specific treatment period of the study if the date and time of onset were after investigational product administration in that period and if it occurred less than equals to (<=) Day 28 and was both not present at the start of that period and was not a chronic condition that was part of the participant's medical history, or it was present at the start of that period or as part of the participant's medical history but the severity or frequency increased during that period <= Day 28. An SAE was defined as any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose.|From the start of study treatment up to 28 days after the last dose of the study treatment (up to 56 days)|Safety analysis set consisted of all participants who were administered at least 1 dose of investigational product.|||Participants|||Number
2560468|NCT02663674|Secondary|Number of the Days of School or Work Missed Due to Illness in the Cocci Positive PP Population|Number of the days of school or work missed due to illness by participant self-report|Visit 1 (Day 1) through Visit 4 (Day 42-46)|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.|||days||Standard Deviation|Mean
2560380|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 180|All Randomized Modified Intent-to-Treat (mITT) population – This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Median
2560381|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 90|All Randomized Modified Intent-to-Treat (mITT) population – This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Median
2560382|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 43|All Randomized Modified Intent-to-Treat (mITT) population – This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Median
2560383|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 29|All Randomized Modified Intent-to-Treat (mITT) population – This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Median
2560384|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 22|All Randomized Modified Intent-to-Treat (mITT) population – This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Median
2560385|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 1|All Randomized Modified Intent-to-Treat (mITT) population – This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Median
2560386|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 180|The All-Randomized PP population includes all participants who took at least one dose of study medication.|||score on a scale||Inter-Quartile Range|Median
2560387|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 90|The All-Randomized PP population includes all participants who took at least one dose of study medication.|||score on a scale||Inter-Quartile Range|Median
2560388|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 43|The All-Randomized PP population includes all participants who took at least one dose of study medication.|||score on a scale||Inter-Quartile Range|Median
2560389|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 29|The All-Randomized PP population includes all participants who took at least one dose of study medication.|||score on a scale||Inter-Quartile Range|Median
2560390|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 22|The All-Randomized PP population includes all participants who took at least one dose of study medication.|||score on a scale||Inter-Quartile Range|Median
2560391|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 1|The All-Randomized PP population includes all participants who took at least one dose of study medication.|||score on a scale||Inter-Quartile Range|Median
2560392|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 180|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Median
2560393|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 90|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Median
2560394|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 43|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Median
2560395|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 29|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Median
2560569|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Rated the Healthcare Professional Global Assessment (HPGA) of Method of Pain Control Over 72 Hours as Good or Excellent"||Up to 72 hours|Overall number of HCPs who completed the assessment. In rare cases, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
2560396|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 22|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Median
2560397|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive Modified Intent-to-Treat Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 1|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Median
2560398|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 180|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.|||score on a scale||Inter-Quartile Range|Median
2560399|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 90|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.|||score on a scale||Inter-Quartile Range|Median
2560400|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 43|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.|||score on a scale||Inter-Quartile Range|Median
2560401|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 29|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.|||score on a scale||Inter-Quartile Range|Median
2560402|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 22|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.|||score on a scale||Inter-Quartile Range|Median
2560469|NCT02663674|Secondary|Number of the Days of School or Work Missed Due to Illness in the All Randomized PP Population|Number of the days of school or work missed due to illness by participant self-report|Visit 1 (Day 1) through Visit 4 (Day 42-46)|The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.|||days||Standard Deviation|Mean
2560403|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci-positive Per-protocol Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 1|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.|||score on a scale||Inter-Quartile Range|Median
2560404|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 180|The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.|||score on a scale||Inter-Quartile Range|Median
2560405|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 90|The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.|||score on a scale||Inter-Quartile Range|Median
2560406|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 43|The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.|||score on a scale||Inter-Quartile Range|Median
2560407|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 29|The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.|||score on a scale||Inter-Quartile Range|Median
2560408|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 22|The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.|||score on a scale||Inter-Quartile Range|Median
2560409|NCT02663674|Secondary|The Median for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 1|The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.|||score on a scale||Inter-Quartile Range|Median
2560410|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 180|All Randomized Modified Intent-to-Treat (mITT) population – This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Standard Deviation|Mean
2560411|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 90|All Randomized Modified Intent-to-Treat (mITT) population – This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Standard Deviation|Mean
2560412|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 43|All Randomized Modified Intent-to-Treat (mITT) population – This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Standard Deviation|Mean
2560413|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 29|All Randomized Modified Intent-to-Treat (mITT) population – This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Standard Deviation|Mean
2560414|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 22|All Randomized Modified Intent-to-Treat (mITT) population – This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Standard Deviation|Mean
2560415|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized mITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 1|All Randomized Modified Intent-to-Treat (mITT) population – This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Standard Deviation|Mean
2560416|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 180|The All-Randomized PP population includes all participants who took at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
2560417|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 90|The All-Randomized PP population includes all participants who took at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
2560418|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 43|The All-Randomized PP population includes all participants who took at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
2560419|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 29|The All-Randomized PP population includes all participants who took at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
2560570|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Rate the Healthcare Professional Global Assessment (HPGA) of Method of Pain Control Over 48 Hours as Good or Excellent"||Up to 48 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
2560420|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 22|The All-Randomized PP population includes all participants who took at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
2560421|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, All Randomized PP Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 1|The All-Randomized PP population includes all participants who took at least one dose of study medication.|||score on a scale||Standard Deviation|Mean
2560422|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 180|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Standard Deviation|Mean
2560423|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 90|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Standard Deviation|Mean
2560424|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 43|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Standard Deviation|Mean
2560425|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 29|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Standard Deviation|Mean
2560426|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 22|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Standard Deviation|Mean
2560427|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive mITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 1|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Standard Deviation|Mean
2560428|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 180|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take >=80% of their expected pills.|||score on a scale||Standard Deviation|Mean
2560429|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 90|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take >=80% of their expected pills.|||score on a scale||Standard Deviation|Mean
2560430|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 43|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take >=80% of their expected pills.|||score on a scale||Standard Deviation|Mean
2560431|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 29|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take >=80% of their expected pills.|||score on a scale||Standard Deviation|Mean
2560432|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 22|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take >=80% of their expected pills.|||score on a scale||Standard Deviation|Mean
2560433|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, Cocci Positive PP Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 1|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the subject needed to take >=80% of their expected pills.|||score on a scale||Standard Deviation|Mean
2560434|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 180|The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.|||score on a scale||Standard Deviation|Mean
2560435|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 90|The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.|||score on a scale||Standard Deviation|Mean
2560436|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 43|The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.|||score on a scale||Standard Deviation|Mean
2560437|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 29|The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.|||score on a scale||Standard Deviation|Mean
2560438|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 22|The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.|||score on a scale||Standard Deviation|Mean
2560439|NCT02663674|Secondary|The Mean for the Mental Component Summary (MCS) and the Physical Component Summary (PCS) Scores of the SF-12v2 Instrument, ITT Population|The SF-12v2 uses 12 questions to measure functional health and well-being from the study participant's perspective across eight domains: physical functioning, role, bodily pain, general health perceptions, vitality, social functioning, emotional role, and mental health. Mental and physical composite scores (MCS & PCS) are computed using the scores of twelve questions and range from 0 to 100, where a higher score indicates better health.|Day 1|The Intent-to-Treat (ITT) population includes all randomized participants with data at the time point.|||score on a scale||Standard Deviation|Mean
2560440|NCT02663674|Secondary|The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants, Regardless of Coccidioidomycosis Status or Adherence to Study Drug|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 2 (Day 20-23)|Intent-to-Treat (ITT) population – This efficacy analysis population includes all randomized participants.|||Participants|||Count of Participants
2560441|NCT02663674|Secondary|Incidence Rate of All-cause Mortality|Mortality information was obtained through medical records or next of kin.|Day 1 through Day 43|The population includes all participants who took at least one dose of study medication.|||participants|||Number
2560442|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 7 (Day 173-187)|All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||Participants|||Count of Participants
2560443|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 6 (Day 83-97)|All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||Participants|||Count of Participants
2560444|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 4 (Day 42-46)|All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||Participants|||Count of Participants
2560445|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 3 (Day 27-30)|All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||Participants|||Count of Participants
2560446|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized mITT Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 2 (Day 20-23)|All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||Participants|||Count of Participants
2560447|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 7 (Day 173-187)|The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.|||Participants|||Count of Participants
2560448|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 6 (Day 83-97)|The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.|||Participants|||Count of Participants
2560449|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 4 (Day 42-46)|The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.|||Participants|||Count of Participants
2560450|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 3 (Day 27-30)|The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.|||Participants|||Count of Participants
2560451|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the All Randomized Per Protocol Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 2 (Day 20-23)|The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.|||Participants|||Count of Participants
2560470|NCT02663674|Secondary|Number of the Days of School or Work Missed Due to Illness in the Cocci Positive mITT Population|Number of the days of school or work missed due to illness by participant self-report|Visit 1 (Day 1) through Visit 4 (Day 42-46)|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||days||Standard Deviation|Mean
2560602|NCT02662569|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12||Baseline and week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2560452|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 7 (Day 173-187)|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||Participants|||Count of Participants
2560453|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 6 (Day 83-97)|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||Participants|||Count of Participants
2560454|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 4 (Day 42-46)|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||Participants|||Count of Participants
2560455|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 3 (Day 27-30)|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||Participants|||Count of Participants
2560456|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive mITT Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 2 (Day 20-23)|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||Participants|||Count of Participants
2560457|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 7 (Day 173-187)|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.|||Participants|||Count of Participants
2560458|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 6 (Day 83-97)|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.|||Participants|||Count of Participants
2560471|NCT02663674|Secondary|Number of the Days of School or Work Missed Due to Illness in the ITT Population|Number of the days of school or work missed due to illness by participant self-report|Visit 1 (Day 1) through Visit 4 (Day 42-46)|The Intent-to-Treat (ITT) population includes all randomized participants.|||days||Standard Deviation|Mean
2560459|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 4 (Day 42-46)|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.|||Participants|||Count of Participants
2560460|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 3 (Day 27-30)|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.|||Participants|||Count of Participants
2560461|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the Cocci Positive Per Protocol Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 2 (Day 20-23)|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.|||Participants|||Count of Participants
2560462|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 7 (Day 173-187)|The Intent-to-Treat (ITT) population includes all randomized participants.|||Participants|||Count of Participants
2560463|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 6 (Day 83-97)|The Intent-to-Treat (ITT) population includes all randomized participants.|||Participants|||Count of Participants
2560464|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 4 (Day 42-46)|The Intent-to-Treat (ITT) population includes all randomized participants.|||Participants|||Count of Participants
2560465|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 3 (Day 27-30)|The Intent-to-Treat (ITT) population includes all randomized participants.|||Participants|||Count of Participants
2560466|NCT02663674|Secondary|Number of Participants Responding to the Individual Items of the PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities - Short Form 4a in the ITT Population|"The PROMIS Ability to Participate in Social Roles and Activities - Short Form 4a uses 4 questions to measure the participant's ability to participate in social roles and activities in the context of family, friends, leisure, and work. Four individual items are answered as Never, Rarely, Sometimes, Usually, or Always with an Always response indicating the most trouble participating in social roles and activities."|Visit 2 (Day 20-23)|The Intent-to-Treat (ITT) population includes all randomized participants.|||Participants|||Count of Participants
2560467|NCT02663674|Secondary|Number of the Days of School or Work Missed Due to Illness in the All Randomized mITT Population|Number of the days of school or work missed due to illness by participant self-report|Visit 1 (Day 1) through Visit 4 (Day 42-46)|All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||days||Standard Deviation|Mean
2560472|NCT02663674|Secondary|The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 4 (Day 42-46)|The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.|||score on a scale||Inter-Quartile Range|Median
2560473|NCT02663674|Secondary|The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 4 (Day 42-46)|The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.|||score on a scale||Inter-Quartile Range|Mean
2560474|NCT02663674|Secondary|The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 3 (Day 27-30)|The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.|||score on a scale||Inter-Quartile Range|Median
2560475|NCT02663674|Secondary|The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 3 (Day 27-30)|The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.|||score on a scale||Inter-Quartile Range|Mean
2560476|NCT02663674|Secondary|The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 2 (Day 20-23)|The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.|||score on a scale||Inter-Quartile Range|Median
2560477|NCT02663674|Secondary|The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Per-Protocol (PP) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 2 (Day 20-23)|The All Randomized Per-Protocol (PP) population includes randomized participants who were compliant with the intervention administration regardless of cocci-status and have coccidioidal serology data available at the Day 1 and 22 visits.|||score on a scale||Inter-Quartile Range|Mean
2560571|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Rated the Healthcare Professional Global Assessment (HPGA) of Method of Pain Control Over 24 Hours as Good or Excellent"||Up to 24 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
2561404|NCT02650921|Secondary|Improvement in Hand as Evaluated by IPR|Independent Photographic Reviewer's assessment of improvement (Yes/No)|12 weeks|ITT|||Participants|||Count of Participants
2560478|NCT02663674|Secondary|The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 4 (Day 42-46)|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.|||score on a scale||Inter-Quartile Range|Median
2560479|NCT02663674|Secondary|The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 4 (Day 42-46)|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.|||score on a scale||Inter-Quartile Range|Mean
2560480|NCT02663674|Secondary|The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 3 (Day 27-30)|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.|||score on a scale||Inter-Quartile Range|Median
2560481|NCT02663674|Secondary|The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 3 (Day 27-30)|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.|||score on a scale||Inter-Quartile Range|Mean
2560482|NCT02663674|Secondary|The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 2 (Day 20-23)|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.|||score on a scale||Inter-Quartile Range|Median
2560483|NCT02663674|Secondary|The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Per-Protocol (PP) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 2 (Day 20-23)|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected pills.|||score on a scale||Inter-Quartile Range|Mean
2560484|NCT02663674|Secondary|The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 4 (Day 42-46)|All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Median
2560485|NCT02663674|Secondary|The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 4 (Day 42-46)|All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Mean
2560486|NCT02663674|Secondary|The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 3 (Day 27-30)|All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Median
2560487|NCT02663674|Secondary|The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 3 (Day 27-30)|All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Mean
2560488|NCT02663674|Secondary|The Median and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 2 (Day 20-23)|All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Median
2560501|NCT02663674|Secondary|The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 2 (Day 20-23)|The Intent-to-Treat (ITT) population includes all randomized participants.|||score on a scale||Inter-Quartile Range|Mean
2560489|NCT02663674|Secondary|The Mean and Quartiles of the FLEET CAP Score and Each Component in the All Randomized Modified Intent-to-Treat (mITT) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 2 (Day 20-23)|All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Mean
2560490|NCT02663674|Secondary|The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 4 (Day 42-46)|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Median
2560491|NCT02663674|Secondary|The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 4 (Day 42-46)|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Mean
2560492|NCT02663674|Secondary|The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 3 (Day 27-30)|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Median
2560493|NCT02663674|Secondary|The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 3 (Day 27-30)|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Mean
2560527|NCT02663232|Secondary|Percentage of Participants Categorized by Tumor Sample Type (Paraffin-embedded Tissue Blocks, Paraffin Block Slides, Cytology Slides, or Other)||Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
2560528|NCT02663232|Secondary|Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites)||Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
2560529|NCT02663232|Secondary|Median Time Since Diagnosis of Melanoma|Median time from the diagnosis of primary melanoma to advanced disease was determined in years.|Day 1|All participants enrolled in the study were included in the analysis except for one participant with missing data.|||years||Full Range|Median
2560530|NCT02663232|Secondary|Percentage of Participants Categorized By LDH Level|Normal LDH levels range from 140 units per liter (U/L) to 280 U/L.|Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
2560494|NCT02663674|Secondary|The Median and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 2 (Day 20-23)|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Median
2560495|NCT02663674|Secondary|The Mean and Quartiles of the FLEET CAP Score and Each Component in the Cocci Positive Modified Intent-to-Treat (mITT) Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 2 (Day 20-23)|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||score on a scale||Inter-Quartile Range|Mean
2560496|NCT02663674|Secondary|The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 4 (Day 42-46)|The Intent-to-Treat (ITT) population includes all randomized participants.|||score on a scale||Inter-Quartile Range|Median
2560497|NCT02663674|Secondary|The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 4 (Day 42-46)|The Intent-to-Treat (ITT) population includes all randomized participants.|||score on a scale||Inter-Quartile Range|Mean
2560498|NCT02663674|Secondary|The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 3 (Day 27-30)|The Intent-to-Treat (ITT) population includes all randomized participants.|||score on a scale||Inter-Quartile Range|Median
2560499|NCT02663674|Secondary|The Mean and Quartiles of the FLEET CAP Score and Each Component in the ITT Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 3 (Day 27-30)|The Intent-to-Treat (ITT) population includes all randomized participants.|||score on a scale||Inter-Quartile Range|Mean
2560500|NCT02663674|Secondary|The Median and Quartiles of the FLEET CAP Score and Each Component in the ITT Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 2 (Day 20-23)|The Intent-to-Treat (ITT) population includes all randomized participants.|||score on a scale||Inter-Quartile Range|Median
2560502|NCT02663674|Secondary|The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the All Randomized mITT Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. Note that a participant who responds earlier before Day 43 does not need to achieve a clinical response at Day 43, as well.|Visit 2 - Visit 4 (Day 20-46)|All Randomized Modified Intent-to-Treat (mITT) population - This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||Participants|||Count of Participants
2560503|NCT02663674|Secondary|The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants Who Took at Least One Dose of Study Medication|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. Note that a participant who responds earlier before Day 43 does not need to achieve a clinical response at Day 43, as well.|Visit 2 - Visit 4 (Day 20-46)|The population includes all participants who took at least one dose of study medication.|||Participants|||Count of Participants
2560504|NCT02663674|Secondary|The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci Positive Modified Intent-to-Treat Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome. Note that a participant who responds earlier before Day 43 does not need to achieve a clinical response at Day 43, as well.|Visit 2 - Visit 4 (Day 20-46)|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||Participants|||Count of Participants
2560505|NCT02663674|Secondary|The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in All Randomized Participants Who Took at Least One Dose of Study Medication|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 2 (Day 20-23)|The population includes all participants who took at least one dose of study medication.|||Participants|||Count of Participants
2560506|NCT02663674|Secondary|The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the All Randomized mITT Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 2 (Day 20-23)|All Randomized Modified Intent-to-Treat (mITT) population – This efficacy analysis population includes all randomized participants who took at least one dose of study medication regardless of cocci-status. Note that it is not necessary for a participants to be adherent to study drug to be eligible for inclusion in the mITT population.|||Participants|||Count of Participants
2560531|NCT02663232|Secondary|Percentage of Participants Categorized by Primary Tumor Location|Primary tumor location included limbs (upper and lower extremities), trunk, head/neck, mucosa, uveal, acral, other (other than these specified locations), unknown (exact location unknown), and not available.|Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
2560532|NCT02663232|Secondary|Percentage of Participants With Sun Exposure|Data were obtained to classify the population with sun exposure as those with low, intermittent or chronic exposure. For the sub-analysis of low, intermittent and chronic exposure, percentages were calculated based on the population with any sun exposure.|Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
2560507|NCT02663674|Secondary|The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci Positive Modified Intent-to-Treat Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 2 (Day 20-23)|Cocci Positive Modified Intent-to-Treat (mITT) population includes all randomized participants who meet the case definition of coccidioidomycosis pneumonia and took at least one dose of study medication. Note that it was not necessary for a participant to be adherent to study drug to be eligible for inclusion in the mITT population.|||Participants|||Count of Participants
2560508|NCT02663674|Primary|The Proportion of Participants Who Achieve a Clinical Response, Defined as at Least a 50% Reduction in Composite FLEET CAP Score From Baseline, in the Cocci-positive Per-protocol Population|The Modified Scoring System for Evaluating Treatment Response in Early Coccidioidal Pneumonia (FLEET CAP) score is a clinical scoring system that allows a constellation of clinical symptoms to be quantified and scored over time: cough, fatigue, chest pain, dyspnea, sputum production, night sweats, fever and hypoxia. The recall period for symptom assessments was during the past week, with the exception of fever and hypoxia, which was measured on the day the FLEET CAP was administered. All symptoms are graded on a 0-3 severity scale, except for night sweats and hypoxia which are graded on a 0-2 severity scale, where 0 indicates the symptom is absent or normal. The range of total scores is from 0-22, where higher scores correspond to a worse outcome.|Visit 2 (Day 20-23)|The cocci-positive per-protocol population includes randomized participants who met the case definition of cocci pneumonia, were adherent with the intervention and had coccidioidal serology data available at the Day 1 and 22 visits. To be considered adherent at the Day 22 visit, the participant needed to take >=80% of their expected capsules.|||Participants|||Count of Participants
2560509|NCT02663453|Secondary|Assessment of Aspartate Aminotransferase (AST)|blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration|3 month||||U/L||Standard Deviation|Mean
2560510|NCT02663453|Secondary|Assessment of Alanine Aminotransferase (ALT)|blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration|3 month||||U/L||Standard Deviation|Mean
2560511|NCT02663453|Secondary|Assessment of Gamma Glutamyltranspeptidase (GGT)|blood samples were obtained before enrollment, week 1, 2 and 3 (U/L) after parenteral nutrition administration|3 month||||U/L||Standard Deviation|Mean
2560512|NCT02663453|Secondary|Head Circumference Gain|in-hospital head circumference gain at birth until discharge (cm/week)|up to 24 weeks||||cm/week||Standard Deviation|Mean
2560513|NCT02663453|Secondary|Height Gain|in-hospital height gain at birth until discharge (cm/week)|up to 24 weeks||||cm/week||Standard Deviation|Mean
2560514|NCT02663453|Secondary|Weight Gain|in-hospital weight gain at birth until discharge (gram/day)|up to 24 weeks||||gram/day||Standard Deviation|Mean
2560515|NCT02663453|Secondary|Incidence of Extrauterine Growth Restriction (EUGR)|weight that is less than the tenth percentile for corrected gestational age by the time of discharge|up to 24 weeks||||Participants|||Count of Participants
2560516|NCT02663453|Secondary|Neonatal Morbidities|retinopathy of prematurity, bronchopulmonary dysplasia|4 months||||Participants|||Count of Participants
2560517|NCT02663453|Primary|Incidence of Neonatal Cholestasis|direct bilirubin level of more than 2 mg/dL|3 months||||Participants|||Count of Participants
2560518|NCT02663232|Secondary|Percentage of Participants With Adequate Quality/Quantity of Tumor Sample||Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
2560519|NCT02663232|Secondary|Percentage Participants Categorized by the Percentage of Tumor Cells Referred to the Technique|The samples were classified based on the percentage of tumor cells referred to the technique as follows: <60 percent (%), 60-80%, >80% and Unknown.|Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
2560520|NCT02663232|Secondary|Percentage of Participants Categorized by Method of BRAF Mutation Testing (Cobas® 4800 BRAF V600 Mutation Test or Others)||Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
2560521|NCT02663232|Secondary|Percentage of Participants Categorized by Method of DNA Extraction (Cobas® BRAF V600 Mutation Test or Others)||Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
2560522|NCT02663232|Secondary|Percentage of Participants With Vascular Invasion|Vascular invasion is defined as the appearance of cancer cells in the lymphatic and blood streams.|Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
2560523|NCT02663232|Secondary|Percentage of Participants With Regression|Regression in melanoma is the replacement of tumor tissue with fibrosis, degenerated melanoma cells, lymphocytic proliferation, and telangiectasia formation.|Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
2560524|NCT02663232|Secondary|Percentage of Participants With Ulceration||Day 1|All participants enrolled in the study were included in the analysis|||percentage of participants|||Number
2560525|NCT02663232|Secondary|Percentage of Participants Categorized by Breslow Thickness|Breslow thickness is defined as the total vertical height of the melanoma, from the very top (called the granular layer) to the area of deepest penetration in the skin. An instrument called an ocular micrometer is used to measure the thickness of the excised (removed) tumor. In general, the higher the Breslow thickness, the worse the prognosis. The classifications were lesser than or equal to (≤) 1.0 millimeters (mm), 1.01 - 2.0 mm, 2.01 - 4.0 mm, greater than (>) 4.0 mm and Unknown.|Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
2560526|NCT02663232|Secondary|Percentage of Participants Categorized by Method of Fixation (Buffered Formalin or Others)||Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
2560534|NCT02663232|Secondary|Percentage of Participants Categorized by Melanoma Stage|Melanoma stages were categorized (according to American Joint Committee on Cancer [AJCC]) as IIIc (advanced stage of melanoma), M1a (metastases to skin, subcutaneous, or distant lymph nodes, normal lactate dehydrogenase (LDH) level, M1b (lung metastases, normal LDH) and M1c (metastases to all other visceral sites and normal LDH or distant metastases to any site combined with an elevated serum LDH level). Of these Stage IIIc was used as the referral category for comparisons.|Day 1|All participants enrolled in the study were included in the analysis.|||percentage of participants|||Number
2560535|NCT02663232|Primary|Percentage of Participants With V600 BRAF Mutation Status|Presence or absence of mutations in the V600 BRAF oncogene was determined in all eligible participants. Data collection and management of BRAF mutation testing was carried out using the Biomarker point® online platform. The platform was used as an electronic case report form (e-CRF) for collecting information in electronic format via a website. Percentage of participants with BRAF mutation status (mutated BRAF, wild type, not available) were reported.|Day 1|All enrolled participants were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2560536|NCT02663128|Primary|PK: Area Under the Concentration Versus Time Curve (AUC) of LY3314814 (AZD3293)||Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose|All participants who received at least one dose of study drug and had evaluable PK data.|||nanogram*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2560537|NCT02663128|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of LY3314814 (AZD3293)||Day 1 of Periods 1, 2, and 3:Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose|All participants who received at least one dose of study drug and had evaluable PK data.|||Hour (h)||Full Range|Median
2560538|NCT02663128|Primary|Pharmacokinetics(PK): Maximum Concentration (Cmax) of LY3314814 (AZD3293)||Day 1 of Periods 1, 2, and 3: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 56, 72, 96, and 120 hours post-dose|All participants who received at least one dose of study drug and had evaluable PK data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2560539|NCT02662764|Primary|Total Amount of Supplemental Morphine (mg) Utilized|Supplemental opioid medication (2 mg IV morphine) was allowed in the first 30 minutes after the first on-demand dose of study drug had been administered, if necessary, to keep a patient comfortable. Otherwise, supplemental opioid medication (2 mg IV morphine, no more frequently than hourly) was allowed for pain due to ambulation or with the initiation of passive range of motion therapy throughout the remainder of the study.|Up to 72 hours|Amount of supplemental morphine (mg) utilized by patients|||amount of morphine (mg) used||Standard Deviation|Mean
2560540|NCT02662764|Primary|Average Inter-dosing Interval (in Minutes)||Up to 72 hours||||average interval (minutes) between doses||Standard Deviation|Mean
2560541|NCT02662764|Primary|Average Hourly Use of Study Drug|Average number of study drug doses used per hour, adjusting by treatment exposure time and study period|Up to 72 hours||||average number of study doses per hour||Standard Deviation|Mean
2560542|NCT02662764|Primary|Number of Study Drug Doses Used||Up to 72 hours||||doses||Standard Deviation|Mean
2560543|NCT02662764|Primary|Nurse Usability Questionnaire (NUQ)|Questionnaire regarding the usability of Zalviso completed by HCPs who had set up at least 5 Zalviso Systems for patients|Up to 72 hours||||percentage of HCPs|||Number
2560544|NCT02662764|Primary|Patient Usability Questionnaire (PUQ)|Questionnaire completed by patients at the end of his/her participation in the study regarding the usability of Zalviso.|Up to 72 hours||||percentage of patients|||Number
2560545|NCT02662764|Primary|Pain Relief (PR) at Each Evaluation Time Point|At protocol-specified time points, the patient is asked to self-record his/her current level of pain relief on 5-point numerical rating scale where 0 equaled no pain relief and 4 equaled complete pain relief. The baseline score references the baseline pain intensity score and the following timepoints reference pain relief scores.|Up to 72 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||units on a scale||Standard Error|Mean
2560546|NCT02662764|Primary|Pain Intensity Difference (PID) at Each Evaluation Time Point|The PID at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. The higher the PID score, the lower the pain intensity. The scores ranged from - 239 to 624.|Up to 72 hours||||units on a scale||Standard Error|Mean
2560547|NCT02662764|Primary|Pain Intensity (PI) at Each Evaluation Time Point|At protocol-specified time points, the patient is asked to self-record his/her current level of pain on an 11-point numerical rating scale where 0 equals no pain and 10 equals the worst possible pain.|Up to 72 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||units on a scale||Standard Error|Mean
2560548|NCT02662764|Primary|Total Pain Relief (TOTPAR) Over the 72-hour Study Period (TOTPAR72)|Total pain relief over the 72-hour study period. A higher TOTPAR means a greater relief in pain. Range of scores was from 0.00 to 288.00.|Up to 72 hours||||units on a scale||Standard Error|Mean
2560549|NCT02662764|Primary|Total Pain Relief (TOTPAR) Over the 48-hour Study Period (TOTPAR48)|Total pain relief over the 48-hour study period. A higher TOTPAR score means a greater relief in pain. Range of scores was from 0.00 to 192.00.|Up to 48 hours||||units on a scale||Standard Error|Mean
2560550|NCT02662764|Primary|Total Pain Relief (TOTPAR) Over the 24-hour Study Period (TOTPAR24)|Total pain relief over the 24-hour study period. A higher TOTPAR score means a greater relief in pain. Range of scores was from 0.00 to 96.00.|Up to 24 hours||||units on a scale||Standard Error|Mean
2560572|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as Excellent"||Up to 72 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
2560573|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as Good"||Up to 72 hours|This assessment was completed by subjects who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
2560551|NCT02662764|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 72-hour Study Period (SPID-72) Study Period|The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and at protocol-specified time points throughout the 72 hour period. The time-weighted SPID72 is the time-weighted summed PID over the 72-hour study period. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity. The scores ranged from -239 to 624.|Up to 72 hours||||units on a scale||Standard Error|Mean
2560552|NCT02662764|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48) Study Period|The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and at protocol-specified time points and throughout the 48 hour period. The time-weighted SPID48 is the time-weighted summed PID over the 48-hour study period. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.The scores ranged from -144 to 408.|Up to 48 hours||||units on a scale||Standard Error|Mean
2560553|NCT02662764|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24)|The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and at protocol-specified time points throughout the 24 hour period. The time-weighted SPID24 is the time-weighted summed PID over the 24-hour study period. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.The scores ranged from - 72 to 204.|Up to 24 hours||||units on a scale||Standard Error|Mean
2560554|NCT02662764|Primary|Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Prior to or During the 72 Hour Study Period||Up to 72 hours||||percentage of patients|||Number
2560555|NCT02662764|Primary|Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia After the 24-hour Study Period and Prior to or During the 48 Hour Study Period||Up to 48 hours||||percentage of patients|||Number
2560556|NCT02662764|Primary|Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Over the 24-hour Study Period||Up to 24 hours||||percentage of patients|||Number
2560557|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as Excellent"||Up to 72 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
2560558|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as Good"||Up to 72 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
2560559|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as Fair"||Up to 72 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
2560560|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as Poor"||Up to 72 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
2560561|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as Excellent"||Up to 48 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
2560562|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA )at 48 Hours as Good"||Up to 48 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
2560563|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as Fair"||Up to 48 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
2560564|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as Poor"||Up to 48 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
2560565|NCT02662764|Primary|"Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as Excellent at 24 Hours"||Up to 24 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
2560566|NCT02662764|Primary|"Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as Good at 24 Hours"||Up to 24 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
2560567|NCT02662764|Primary|"Percentage of Healthcare Professional Global Assessment (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as Fair at 24 Hours"||Up to 24 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
2560568|NCT02662764|Primary|"Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as Poor at 24 Hours"||Up to 24 hours|Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.|||percentage of HCPs|||Number
2560576|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as Excellent"||Up to 48 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
2560577|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as Good"||Up to 48 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
2560578|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as Fair"||Up to 48 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
2560579|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as Poor"||Up to 48 hours|This assessment was completed by subjects who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
2560580|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as Excellent at 24 Hours"||Up to 24 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
2560581|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as Good at 24 Hours"||Up to 24 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
2560582|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as Fair at 24 Hours"||Up to 24 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
2560583|NCT02662764|Primary|"Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as Poor at 24 Hours"||Up to 24 hours|This assessment was completed by subjects who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
2560584|NCT02662764|Primary|"Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 72 Hours as Good or Excellent"||Up to 72 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
2560585|NCT02662764|Primary|"Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 48 Hours as Good or Excellent"||Up to 48 hours|This assessment completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
2560586|NCT02662764|Primary|"Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 24 Hours as Good or Excellent"||Up to 24 hours|This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.|||percentage of patients|||Number
2560587|NCT02662764|Primary|Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet That Caused an Analgesic Gap||Up to 72 hours||||percentage of participants|||Number
2560588|NCT02662764|Primary|Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System||Up to 72 hours||||percentage of patients|||Number
2560589|NCT02662764|Primary|Number of Zalviso System Notifications to the Nurse to Retrain Patient to Not Pull Down on the Controller While Dosing||Up to 72 hours||||Notifications|||Number
2560590|NCT02662764|Primary|Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet (i.e., a Dispense Failure)||Up to 72 hours||||percentage of patients|||Number
2560591|NCT02662764|Primary|Number of Misplaced Tablets (i.e., Tablet Found Outside the Patient's Mouth)||Up to 24 hours||||tablets|||Number
2560592|NCT02662764|Primary|Percentage of Patients With Misplaced Tablet(s)||Up to 72 hours||||percentage of patients|||Number
2560593|NCT02662764|Primary|Percentage of Patients, if Any, With Tablet Dispensed When the Zalviso System Was in Lockout||Up to 72 hours||||percentage of patients|||Number
2560594|NCT02662764|Primary|Percentage of Patients, if Any, With Tablets Dispensed But Not Requested||Up to 72 hours||||percentage of patients|||Number
2560595|NCT02662764|Primary|Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System||Up to 72 hours||||percentage of patients|||Number
2560596|NCT02662608|Primary|Number of Participants With Disease Progression|Tumor response for measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) to establish disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|6 weeks||||Participants|||Count of Participants
2560597|NCT02662569|Secondary|Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2560598|NCT02662569|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2560599|NCT02662569|Secondary|Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2560600|NCT02662569|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2560601|NCT02662569|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2560620|NCT02662556|Secondary|"Percentage of Healthcare Professionals Who Responded to the Global Assessments as Excellent or Good"|"Healthcare professionals were asked Overall, how would you rate the method of pain control? Poor (1) Fair (2) Good (3) Excellent (4)"|12 hours or until patients' termination from study||||percentage of healthcare professionals||95% Confidence Interval|Number
2560621|NCT02662556|Secondary|"Percentage of Patients Who Responded to the Global Assessments as Excellent or Good"|"Patients were asked Overall, how would you rate the method of pain control? Poor (1), Fair (2), Good (3), or Excellent (4)"|12 hours or at patients' termination from study|135 patients completed the scale|||percentage of subjects||95% Confidence Interval|Number
2560622|NCT02662556|Secondary|Time-weighted Summed Pain Intensity Difference (SPID) Over the First Hour (SPID1).|The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 1 hour period. The time-weighted SPID1 is the time-weighted summed PID over the 1-hour study period. The scores ranged from -6.67 to 6.77. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.|1 hours||||units on a scale||Standard Error|Mean
2560623|NCT02662556|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).|The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour period. The time-weighted SPID12 is the time-weighted summed PID over the 12-hour study period. The scores ranged from -13.75 to 100.5. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.|12-hours||||units on a scale||Standard Error|Mean
2560624|NCT02662387|Secondary|Time Between Admission to Pediatric ICU to Discharge From Pediatric ICU|Actual length of stay in pediatric ICU from admission to discharge|From subject enrollment to hospital discharge, not >170 hr||||hours||Full Range|Median
2560625|NCT02662387|Primary|Change of Respiratory Status Using the Modified Bronchiolitis Severity Score, in Children Using External Nasal Dilators as an Adjuvant to High Flow Nasal Cannula Oxygen Therapy Compared to Those Receiving High Flow Nasal Cannula Therapy Alone|Change of respiratory status using the Modified Bronchiolitis Severity Score in children using External Nasal Dilators as an adjuvant to High Flow Nasal Cannula oxygen therapy compared to those receiving High Flow Nasal Cannula therapy alone - shows that there is change in respiratory parameters, with positive number reflecting increases, and negative numbers reflecting decreases in number Modified Bronchiolitis Severity Score is measured by combining the individual score for five respiratory parameters (respiratory rate, breath sounds, work of breathing, oxygen saturation, mental status); score for each parameter ranges from 0-3; final score of each parameter is measured by adding them up; and so MBSS score ranges from 0-15; higher the score, worse the clinical status)|Change from baseline to time of hospital discharge, no greater than 1 month||||number/score||Full Range|Mean
2560626|NCT02662244|Secondary|Clinical and Photographic Evidence of Extent of Blistering Occurring After Each Treatment|"The treatment area will be assessed for blistering using the following scale:~0 = absence~1 = mild~2 = moderate~3 = severe"|30 days|Clinical and photographic evidence of extent of blistering after treatment was evaluated by the investigator with the above scores|||score on a scale|blistering|Full Range|Mean
2560627|NCT02662244|Secondary|Clinical and Photographic Evidence of Extent of Erythema Occurring After Each Treatment|"The treatment area will be assessed for erythema using the following scale:~0 = absence~1 = mild~2 = moderate~3 = severe"|30 days|Clinical and photographic evidence of extent of erythema was evaluated by the investigator with the above scores.|||score on a scale|erythema|Full Range|Mean
2560628|NCT02662244|Secondary|• Clinical and Photographic Evidence of Extent of Edema Occurring After Each Treatment|"3. The treatment area will be assessed for edema using the following scale:~0 = absence~1 = mild~2 = moderate~3 = severe"|30 days|Clinical and photographic evidence of extent of edema was evaluated by the investigator with the above scores at b|||score on a scale|edema|Full Range|Mean
2560629|NCT02662244|Secondary|• Clinical and Photographic Evidence of Extent of Purpura After Each Treatment|"11. The treatment area will be assessed post laser and at the final evaluation visit for purpura using the following scale:~0 = absence~1 = mild~2 = moderate~3 = severe"|30 days|All participants' purpura was analyzed on a scale of 0 to 3|||score on a scale|purpura|Full Range|Mean
2560630|NCT02662244|Primary|This is a Study to Measure the Efficacy of the Nd:YAG Laser to Cause Complete Regression of Basal Cell Carcinoma.|"The primary outcome data collected during the study will include:~Number of tumors that showed histologic complete regression."|The primary outcome of the study is histologic clearance of BCC tumor 30 days|31 Adults over 18 years with a biopsy‐proven BCC of any non‐aggressive subtype with a residual clinical lesion were included. BCC lesions were required to be less than 2.1 cm in diameter and located on the trunk or extremities. The number of tumors that showed complete regression were analyzed for primary outcome.|||tumors|tumors||Number
2560631|NCT02662036|Secondary|Cost of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl When Accounting for Length of Hospital Stay and Use of Other Analgesics||Up to 2 weeks post-operation|Data was not collected for this outcome measure. There was no funding to collect or analyze the data. Also it was determined that the concept of cost was highly variable at the hospital and any data that was obtained would lack granular costs on most items. Lacking this granularity would make any results meaningless.||||||
2560632|NCT02662036|Secondary|Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery|"Quality of Recovery -15 questionnaire~Part A has 10 questions that asks how the participant has been feeling in the last 24 hours with answers ranging from 0=none of the time to 10=all of the time~Part B has 5 questions asking the participant if they have had any of the following including pain, nausea, vomiting, anxiety, and depression) with answers ranging from 0=none of the time to 10=all of the time.~The total score allowed is 150 (range 0-150) with the higher the number the worse the participant is feeling and the lower the number the better the participant is feeling"|At post operative day 2, discharge, and at 1-2 week follow-up||||score on a scale||Full Range|Median
2560633|NCT02662036|Secondary|Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores|"Pain scale uses Wong-Baker FACES Pain Rating Scale~The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain"|72 hours after surgery||||score on a scale||Full Range|Median
2560634|NCT02662036|Secondary|Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores|"Pain scale uses Wong-Baker FACES Pain Rating Scale~The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain"|48 hours after surgery||||score on a scale||Full Range|Median
2560635|NCT02662036|Secondary|Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores|"Pain scale uses Wong-Baker FACES Pain Rating Scale~The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain"|24 hours after surgery||||score on a scale||Full Range|Median
2560636|NCT02662036|Secondary|Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores|"Pain scale uses Wong-Baker FACES Pain Rating Scale~The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain"|12 hours after surgery||||score on a scale||Full Range|Median
2560637|NCT02662036|Secondary|Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Duration of Urinary Catheter||Up to 2 weeks post-operation||||days||Full Range|Median
2560638|NCT02662036|Secondary|Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Time Until Ambulation||Up to 2 weeks post-operation||||days||Full Range|Median
2560639|NCT02662036|Secondary|Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Length of Hospital Stay||Up to day of discharge from hospital, up to 7 days||||days||Full Range|Median
2560640|NCT02662036|Secondary|Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay||Up to day of discharge from hospital (expected hospital stay of 5 days)||||mg||Full Range|Median
2560641|NCT02662036|Primary|Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay||Up to day of discharge from hospital (expected hospital stay of 5 days)||||mg||Full Range|Median
2560642|NCT02661828|Secondary|Number of Participants Who Meet Criteria for Antidepressant Discontinuation Syndrome|"Antidepressant Discontinuation Syndrome is defined as greater than or equal to 4 new or worsened Discontinuation Emergent Signs and Symptoms Scale (DESS) symptoms at a visit during the study.~Symptoms are rated on a scale of 1-5:~New symptom~Old symptom but worse~Old symptom but improved~Old symptom but unchanged~Symptom not present"|Duration of Study (Up to 14 Months)||||Participants|||Count of Participants
2560643|NCT02661828|Secondary|Physician Withdrawal Checklist (PWC-20) Scores|"To determine a change in the Intensity of Discontinuation symptoms, the Physician Withdrawal Checklist (PWC-20) will be administered by a trained clinician/rater to assess the intensity of discontinuation symptoms. The assessment has 20 items evaluated to detect withdrawal symptoms. Symptoms are rated on a scale of 0-3.~0. Not present~Mild~Moderate~Severe~Total scores range from 0 to 60 with higher scores indicating more severe symptoms."|Baseline (Post-Taper), Visit 4 (3 Weeks Post Baseline)||||units on a scale|||Number
2560644|NCT02661828|Primary|Discontinuation Emergent Signs and Symptoms Scale (DESS) Scores|"To determine a change in the frequency of Discontinuation symptoms, the Discontinuation Emergent Signs and Symptoms Scale (DESS) will be administered by a trained clinician/rater to assess the frequency of discontinuation symptoms. The assessment has 43 items to evaluate discontinuation-emergent symptoms resulting from withdrawal from their antidepressant medication. Symptoms are rated on a scale of 1-5:~New symptom~Old symptom but worse~Old symptom but improved~Old symptom but unchanged~Symptom not present~Total score = sum of number of new symptoms and old (but worse) symptoms (score = 1) and old and unchanged symptom, absent, or old symptom but improved (score = 0); total possible range 0 to 43. Higher score = more symptoms."|Baseline (Post-Taper), Visit 4 (3 Weeks Post Baseline)||||units on a scale|||Number
2560645|NCT02661815|Secondary|Progression-free Survival (PFS)|No assessed, study was terminated.|2 years|||||||
2560646|NCT02661815|Secondary|Duration Of Overall Response, Measured From The Time Measurement Criteria Are Met For PR or CR Until The First Date Recurrent Or Progressive Disease Is Objectively Documented.|Not assessed, study was terminated.|2 years|||||||
2560647|NCT02661815|Secondary|Peripheral Neurotoxicity Assessed Using TNS by Measuring 5 Categories|No assessed TNS would only be assessed during escalation which we did not reach as the study was terminated.|0 years|||||||
2560648|NCT02661815|Primary|Best Overall Response Measured From, Start Of Treatment To The End|This is now the primary outcome measure as the study was terminated prematurely.|13 months|Of the six participants, four were evaluable for response by RECIST version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least 30% decrease|||participants|||Number
2560649|NCT02661815|Primary|Analysis Report on the MTD In The Dose Escalation Portion Of The Study|Not assessed, the MTD was not reached as the study was terminated.|2 years|Data not collected as study was terminated before MTD was reached.|||Participants|||Count of Participants
2560650|NCT02661737|Primary|Incidence of Device-related Adverse Events||Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years||||Participants|||Count of Participants
2560651|NCT02661594|Primary|Maximal Mean ΔΔQTcF|"Maximal mean placebo-corrected change from baseline of QTcF (QT interval corrected for heart rate using the Fridericia formula) for single 5 mg and 40 mg iv doses of APD421. At each time point (2 mins, 8 mins, etc) the QTcF is compared to the pre-dosing baseline value, in order to calculate the change in QTcF (ΔQTcF). The value of ΔQTcF at each time point is then compared against the same time point for a placebo infusion, and the difference is calculated (ΔΔQTcF)."|24 hours||||milliseconds||90% Confidence Interval|Mean
2560652|NCT02661256|Secondary|Pharyngeal Residue|the presence of residual barium coating the pharyngeal walls, pooling in the vallecula or pyriform sinuses post swallow (absent/mild/severe). This measure is subjective (mild = light coating and sever = significant coating of residual barium).|<5 seconds post swallow trigger||||participants|||Number
2560653|NCT02661256|Secondary|Nasopharyngeal Reflux|the occurrence of barium detected in the nasopharynx, posterior or superior to the velum|<2 seconds post swallow trigger||||percentage of nasopharyngeal reflux||Standard Deviation|Mean
2560655|NCT02661256|Secondary|Percentage of Laryngeal Length|Will be measuredmeasured by deep penetration, the occurrence of barium underneath the epiglottis, in the laryngeal vestibule to the level of the vocal folds|<2 seconds post swallow trigger||||percentage of deep penetration||Standard Deviation|Mean
2560656|NCT02661256|Secondary|Tracheal Aspiration|the occurrence of barium below the level of the true vocal cords|<5 seconds post swallow trigger||||percentage of aspiration||Standard Deviation|Mean
2560657|NCT02661256|Primary|Pharyngeal Phase Dysphagia|presence of atypical or disordered movements during the pharyngeal phase of swallowing|<5 seconds post swallow trigger||||Participants|||Count of Participants
2560658|NCT02661178|Secondary|Effect of Food on the Bioavailability (AUC24) of Emodepside (BAY 44-4400) After Single Oral Dose Administered as Solution or IR Tablets in One Arm Only|Results of the statistical analysis of the effect of food on Emodepside exposure, after a single dose of 10 mg Emodepside LSF solution.|From pre-dose until 336h post-dose (may be extended to 504h post-dose)|emodepside assessed in fasted condition: only one cohort (10mg solution) assessed with high fat high calories meal.|||ng*h/mL||Full Range|Least Squares Mean
2560659|NCT02661178|Secondary|Effect of Food on the Bioavailability (Cmax) of Emodepside (BAY 44-4400) After Single Oral Dose Administered as Solution or IR Tablets in One Arm Only|Results of the statistical analysis of the effect of food on Emodepside exposure, after a single dose of 10 mg Emodepside LSF solution.|From pre-dose until 336h post-dose (may be extended to 504h post-dose)|emodepside assessed in fasted condition: only one cohort (10mg solution) assessed with high fat high calories meal.|||ng/ml||Full Range|Least Squares Mean
2560660|NCT02661178|Secondary|The AUC Last, Norm of Emodepside in Plasma|The area under the concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration normalized by dose and body weight (AUClast/(Dose administered*body weight))|From pre-dose until 336h post-dose (may be extended to 504h post-dose)|PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).|||(h*ng/mL)/(mg*kg)||Geometric Coefficient of Variation|Geometric Mean
2560661|NCT02661178|Secondary|Frel of the IR (Immediate Release) Tablet of Emodepside|The average relative bioavailability (Frel) of the IR tablet was calculated|From pre-dose until 336h post-dose (may be extended to 504h post-dose)|PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).|||Frel percentage||90% Confidence Interval|Number
2560662|NCT02661178|Secondary|The AUC Last of Emodepside in Plasma|The area under the concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration (t), calculated using the linear trapezoidal method for increasing concentrations and the log trapezoidal method for decreasing concentrations|From pre-dose until 336h post-dose (may be extended to 504h post-dose)|PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2560663|NCT02661178|Secondary|The Vz/F of Emodepside in Plasma|Apparent volume of distribution (Vz/F) was calculated as Vz/F = Dose/(λz × AUC∞), where λz is the apparent terminal elimination rate constant, estimated by linear regression of log-transformed concentration versus time data|From pre-dose until 336h post-dose (may be extended to 504h post-dose)|PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).|||Litres||Geometric Coefficient of Variation|Geometric Mean
2560664|NCT02661178|Secondary|The AUC 24, Norm of Emodepside in Plasma|Area under the concentration-time curve from time zero (pre-dose) to 24 h, normalized by dose and body weight (AUC 24, norm) was calculated as AUC0-24/(Dose administered*body weight)|From pre-dose until 336h post-dose (may be extended to 504h post-dose)|PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).|||(h*ng/mL)/(mg*kg)||Geometric Coefficient of Variation|Geometric Mean
2560665|NCT02661178|Secondary|The AUC 0-24/D of Emodepside in Plasma|Dose-normalized area under the concentration-time curve (AUC) from time zero (pre-dose) to 24 h was calculated as AUC0-24/Dose administered|From pre-dose until 336h post-dose (may be extended to 504h post-dose)|PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).|||(h.ng/mL)/mg)||Geometric Coefficient of Variation|Geometric Mean
2560666|NCT02661178|Secondary|The AUC 0-24 of Emodepside in Plasma|Area under the plasma concentration-time curve from time zero (pre-dose) to 24 h was calculated using the trapezoidal method|From pre-dose until 336h post-dose (may be extended to 504h post-dose)|PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2560667|NCT02661178|Secondary|The CL/F of Emodepside in Plasma|Apparent total clearance from plasma (CL/F) was calculated as CL/F = Dose/AUC∞|From pre-dose until 336h post-dose (may be extended to 504h post-dose)|PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).|||L/hour||Geometric Coefficient of Variation|Geometric Mean
2561405|NCT02650921|Secondary|Responder Rate Using Validated Hand Grading Scale|A responder is defined as a hand with at least one point improvement from baseline.|24 weeks|ITT|||Participants|||Count of Participants
2560668|NCT02661178|Secondary|The MRT of Emodepside in Plasma|The mean residence time (MRT) was calculated as MRT = AUMC/AUC∞, where AUMC is the area under the first moment of the concentration-time curve from zero time (pre-dose) extrapolated to infinite time|From pre-dose until 336h post-dose (may be extended to 504h post-dose)|PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).|||Hours||Geometric Coefficient of Variation|Geometric Mean
2560669|NCT02661178|Secondary|The t½ of Emodepside in Plasma|Terminal half-life (t½), calculated according to the equation t½ = ln2/λz, where λz is the apparent terminal elimination rate constant, estimated by linear regression of log-transformed concentration versus time data|From pre-dose until 336h post-dose (may be extended to 504h post-dose)|PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived)|||Hours||Geometric Coefficient of Variation|Geometric Mean
2560670|NCT02661178|Secondary|The Tmax of Emodepside in Plasma|Time to reach maximum plasma concentration (Tmax) was obtained directly from the concentration-time data|From pre-dose until 336h post-dose (may be extended to 504h post-dose)|PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived)|||Hours||Full Range|Mean
2560671|NCT02661178|Secondary|The Cmax, Norm of Emodepside in Plasma|The observed maximum plasma concentration (Cmax) normalized by dose and body weight was calculated as Cmax/(Dose administered*body weight)|From pre-dose until 336h post-dose (may be extended to 504h post-dose)|PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).|||(ng/mL)/(mg*kg)||Geometric Coefficient of Variation|Geometric Mean
2560672|NCT02661178|Secondary|The Cmax/D of Emodepside in Plasma|Dose-normalized observed maximum plasma concentration (Cmax/D) was calculated as Cmax/Dose administered|From pre-dose until 336h post-dose (may be extended to 504h post-dose)|PK Concentration data were summarized using the PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).|||(ng/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
2560673|NCT02661178|Secondary|The Cmax of Emodepside in Plasma|Maximum observed plasma concentration (Cmax) was obtained directly from the concentration-time data|From pre-dose until 336h post-dose (may be extended to 504h post-dose)|PK Concentration were summarized using PK concentration population (all subjects who received at least one dose of study drug and for whom a PK sample was analyzed). PK parameters were summarized using the PK Parameter population (all subjects in the PK Concentration Population for whom PK parameters could be derived).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2560674|NCT02661178|Secondary|The AUC∞/D of Emodepside in Plasma|Dose-normalized area under the plasma drug concentration versus time curve from time zero to infinity (AUC∞/D), calculated as AUC∞/Dose administered.|From pre-dose until 336h post-dose (may be extended to 504h post-dose)|It is unacceptable to use AUCinf data if>40% of the AUC has been extrapolated.This is in line with literature(Gabrielson&Weiner, 2000).The AUCinf values with<20% of the area extrapolated (reliable results) have not been summarised in the tables because n is either 1 or 2 per treatment (n=2 only for 1m solution).|||No values calculated|||Number
2560675|NCT02661178|Secondary|The AUC∞ of Emodepside in Plasma|The area under the plasma drug concentration versus time curve from time zero to infinity (AUC∞)|From pre-dose until 336h post-dose (may be extended to 504h post-dose)|It is unacceptable to use AUCinf data if>40% of the AUC has been extrapolated.This is in line with literature(Gabrielson&Weiner, 2000).The AUCinf values with<20% of the area extrapolated (reliable results) have not been summarised in the tables because n is either 1 or 2 per treatment (n=2 only for 1m solution).|||h*ng/ml||Standard Deviation|Geometric Mean
2560676|NCT02661178|Primary|Safety and Tolerability as Measured by Ophthalmological Examination Findings in One Study Arm Only|Subjects attended a specialist eye hospital for ophthalmology assessments by a Consultant Ophthalmologist. Opthalmology assessments included:ocular symptoms, past ocular history, auto-refraction, best corrected distance visual acuity, color vision assessment, amsler grid assessment, ocular alignment and ocular motility assessment, confrontation visual field assessment, slit lamp examination (anterior segment), intraocular pressure (Goldmann Tonometry), optical coherence scanning of tomography, post mydriatic ocular media (at Screening visit 2 only) and retinal examination with slit lamp and lens.|Up to 14 days post dose (may be extended to 21 days)|AEs were determined in the Safety Population. Opthalmology examinations were only performed for the Emodepside 40mg group (n=6) and the corresponding placebo group (n=2)|||participants|||Number
2560677|NCT02661178|Primary|Safety and Tolerability as Measured by Clinical Laboratory Parameters|Clinical laboratory parameters included hematology, biochemistry, serology and coagulation in blood samples and urinalysis in urine samples|Up to 14 days post dose (may be extended to 21 days)|AEs were determined in the Safety Population. In Part 1 n=63 (n=62 subjects completed). One subject in the 1mg emodepside group was withdrawn after receiving 0.1mg emodepside LSF, owing to an AE. He consented to follow-up safety assessment until Day 7 as a 0.1mg emodepside group.|||participants|||Number
2560678|NCT02661178|Primary|Safety and Tolerability as Measured by 12-lead ECG|The following variables were recorded in 12-lead ECGs and extracted from continuous 12-lead ECG recordings: ventricular rate, PR interval, QRS interval, QTcB and QTcF interval.|Up to 14 days post dose (may be extended to 21 days)|AEs were determined in the Safety Population. In Part 1 n=63 (n=62 subjects completed). One subject in the 1mg emodepside group was withdrawn after receiving 0.1mg emodepside LSF, owing to an AE. He consented to follow-up safety assessment until Day 7 as a 0.1mg emodepside group.|||participants|||Number
2561406|NCT02650921|Secondary|Responder Rate Using Validated Hand Grading Scale|A responder is defined as a hand with at least one point improvement from baseline|20 weeks|ITT|||Participants|||Count of Participants
2560679|NCT02661178|Primary|Safety and Tolerability as Measured by Vital Signs|Vital signs included heart rate, systolic and diastolic blood pressure,|Up to 14 days post dose (may be extended to 21 days)|AEs were determined in the Safety Population. In Part 1 n=63 (n=62 subjects completed). One subject in the 1mg emodepside group was withdrawn after receiving 0.1mg emodepside LSF, owing to an AE. He consented to follow-up safety assessment until Day 7 as a 0.1mg emodepside group.|||participants|||Number
2560680|NCT02661178|Primary|Safety and Tolerability as Measured by Physical and Neurological Examination Findings|Abnormal or clinically significant neurological examination findings during the study or reported as an AE|Up to 14 days post dose (may be extended to 21 days)|AEs were determined in the Safety Population. In Part 1 n=63 (n=62 subjects completed). One subject in the 1mg emodepside group was withdrawn after receiving 0.1mg emodepside LSF, owing to an AE. He consented to follow-up safety assessment until Day 7 as a 0.1mg emodepside group.|||participants|||Number
2560681|NCT02661178|Primary|Safety and Tolerability as Measured by Adverse Events|Deaths, serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)|Up to 14 days post dose (may be extended to 21 days)|"AEs were determined in the Safety Population. In Part 1 n=63 (n=62 subjects completed). One subject in the 1mg emodepside group was withdrawn after receiving 0.1mg emodepside LSF, owing to an AE. He consented to follow-up safety assessment until Day 7 as a 0.1mg emodepside group.~In Part 2, n=16 (n=16 subjects completed)"|||participants|||Number
2560682|NCT02661126|Primary|t½ of Ruzasvir|t1/2 is the amount of time required to clear 50% of ruzasvir from plasma following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2560683|NCT02661126|Primary|Vz/F of Ruzasvir|Vz/F is the apparent volume of distribution of ruzasvir following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2560684|NCT02661126|Primary|CL/F of Ruzasvir|CL/F is the apparent total body clearance of ruzasvir following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||Liters/hour||Geometric Coefficient of Variation|Geometric Mean
2560685|NCT02661126|Primary|Tmax of Ruzasvir|Tmax is the time required to reach the maximum post-dose plasma concentration of ruzasvir following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis|||Hours||Full Range|Median
2560686|NCT02661126|Primary|C24 of Ruzasvir|C24 is the plasma concentration of ruzasvir 24 hours following oral administration of MK-3682B.|24 hours post-dose|All participants are included in the analysis.|||nM||95% Confidence Interval|Geometric Mean
2560687|NCT02661126|Primary|Cmax of Ruzasvir|Cmax is the maximum amount of ruzasvir in plasma following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||nM||95% Confidence Interval|Geometric Mean
2560688|NCT02661126|Primary|AUC0-24 of Ruzasvir|AUC0-24 is a measure of total exposure to ruzasvir in plasma from dosing to 24 hours following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose|All participants are included in the analysis.|||uM*hr||95% Confidence Interval|Geometric Mean
2560689|NCT02661126|Primary|AUC0-∞ of Ruzasvir|AUC0-∞ is a measure of total exposure to ruzasvir in plasma from the start of dosing to infinity following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||uM*hr||95% Confidence Interval|Geometric Mean
2560690|NCT02661126|Primary|AUC0-last of Ruzasvir (MK-8408)|AUC0-last is a measure of total exposure to ruzasvir in plasma from the start of dosing to the time of the last quantifiable (<LLOQ) sample following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||uM*hr||95% Confidence Interval|Geometric Mean
2560691|NCT02661126|Primary|t½ of Grazoprevir|t1/2 is the amount of time required to clear 50% of grazoprevir from plasma following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|"All participants except 1 are included in the analysis. One participant in the Moderate RI group did not have a well characterized terminal phase and their value was set to missing."|||Hours||Geometric Coefficient of Variation|Geometric Mean
2560692|NCT02661126|Primary|Vz/F of Grazoprevir|Vz/F is the apparent volume of distribution of grazoprevir following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|"All participants except 1 are included in the analysis. One participant in the Moderate RI group did not have a well characterized terminal phase and their value was set to missing."|||Liters||Geometric Coefficient of Variation|Geometric Mean
2560693|NCT02661126|Primary|CL/F of Grazoprevir|CL/F is the apparent total body clearance of grazoprevir following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|"All participants except 1 are included in the analysis. One participant in the Moderate RI group did not have a well characterized terminal phase and their value was set to missing."|||Liters/hour||Geometric Coefficient of Variation|Geometric Mean
2560694|NCT02661126|Primary|Tmax of Grazoprevir|Tmax is the time required to reach the maximum post-dose plasma concentration of grazoprevir following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis|||Hours||Full Range|Median
2560695|NCT02661126|Primary|C24 of Grazoprevir|C24 is the plasma concentration of grazoprevir 24 hours following oral administration of MK-3682B.|24 hours post-dose|All participants are included in the analysis.|||nM||95% Confidence Interval|Geometric Mean
2560696|NCT02661126|Primary|Cmax of Grazoprevir|Cmax is the maximum amount of grazoprevir in plasma following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||nM||95% Confidence Interval|Geometric Mean
2560697|NCT02661126|Primary|AUC0-24 of Grazoprevir|AUC0-24 is a measure of total exposure to grazoprevir in plasma from the start of dosing to 24 hours post-dose following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose|All participants are included in the analysis.|||uM*hr||95% Confidence Interval|Geometric Mean
2560698|NCT02661126|Primary|AUC0-∞ of Grazoprevir|AUC0-∞ is a measure of total exposure to grazoprevir in plasma from the start of dosing to infinity following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|"All participants except 1 are included in the analysis. One participant in the Moderate RI group did not have a well characterized terminal phase and their value was set to missing."|||uM*hr||95% Confidence Interval|Geometric Mean
2560699|NCT02661126|Primary|AUC0-last of Grazoprevir (MK-5172)|AUC0-last is a measure of total exposure to grazoprevir in plasma from the start of dosing to the time of the last quantifiable (<LLOQ) sample following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||uM*hr||95% Confidence Interval|Geometric Mean
2560700|NCT02661126|Primary|t½ of Uprifosbuvir Metabolite M6|t1/2 is the amount of time required to clear 50% of uprifosbuvir metabolite M6 from plasma following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2560701|NCT02661126|Primary|Tmax of Uprifosbuvir Metabolite M6|Tmax is the time required to reach the maximum post-dose plasma concentration of uprifosbuvir metabolite M6 following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis|||Hours||Full Range|Median
2560702|NCT02661126|Primary|C24 of Uprifosbuvir Metabolite M6|C24 is the plasma concentration of uprifosbuvir metabolite M6 24 hours following oral administration of MK-3682B.|24 hours post-dose|All participants are included in the analysis.|||nM||95% Confidence Interval|Geometric Mean
2560703|NCT02661126|Primary|Cmax of Uprifosbuvir Metabolite M6|Cmax is the maximum amount of uprifosbuvir metabolite M6 in plasma following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||nM||95% Confidence Interval|Geometric Mean
2560704|NCT02661126|Primary|AUC0-24 of Uprifosbuvir Metabolite M6|AUC0-24 is a measure of total exposure to uprifosbuvir metabolite M6 in plasma from dosing to 24 hours following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose|All participants are included in the analysis.|||uM*hr||95% Confidence Interval|Geometric Mean
2560705|NCT02661126|Primary|AUC0-∞ of Uprifosbuvir Metabolite M6|AUC0-∞ is a measure of total exposure to uprifosbuvir metabolite M6 in plasma from the start of dosing to infinity following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||uM*hr||95% Confidence Interval|Geometric Mean
2560706|NCT02661126|Primary|AUC0-last of Uprifosbuvir Metabolite M6|AUC0-last is a measure of total exposure to uprifosbuvir metabolite M6 in plasma from the start of dosing to the time of the last quantifiable (<LLOQ) sample following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||uM*hr||95% Confidence Interval|Geometric Mean
2560707|NCT02661126|Primary|t½ of Uprifosbuvir Metabolite M5|t1/2 is the amount of time required to clear 50% of uprifosbuvir metabolite M5 from plasma following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2560708|NCT02661126|Primary|Lag Time (Tlag) of Uprifosbuvir Metabolite M5|Tlag is the time from dosing to first appearance in plasma of uprifosbuvir metabolite M5 following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis|||Hours||Full Range|Median
2560709|NCT02661126|Primary|Tmax of Uprifosbuvir Metabolite M5|Tmax is the time required to reach the maximum post-dose plasma concentration of uprifosbuvir metabolite M5 following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis|||Hours||Full Range|Median
2560710|NCT02661126|Primary|C24 of Uprifosbuvir Metabolite M5|C24 is the plasma concentration of uprifosbuvir metabolite M5 24 hours following oral administration of MK-3682B.|24 hours post-dose|All participants are included in the analysis.|||nM||95% Confidence Interval|Geometric Mean
2560711|NCT02661126|Primary|Cmax of Uprifosbuvir Metabolite M5|Cmax is the maximum amount of uprifosbuvir metabolite M5 in plasma following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||nM||95% Confidence Interval|Geometric Mean
2560712|NCT02661126|Primary|AUC0-24 of Uprifosbuvir Metabolite M5|AUC0-24 is a measure of total exposure to uprifosbuvir metabolite M5 in plasma from dosing to 24 hours following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose|All participants are included in the analysis.|||uM*hr||95% Confidence Interval|Geometric Mean
2560713|NCT02661126|Primary|AUC0-∞ of Uprifosbuvir Metabolite M5|AUC0-∞ is a measure of total exposure to uprifosbuvir metabolite M5 in plasma from the start of dosing to infinity following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||uM*hr||95% Confidence Interval|Geometric Mean
2560714|NCT02661126|Primary|AUC0-last of Uprifosbuvir Metabolite M5|AUC0-last is a measure of total exposure to uprifosbuvir metabolite M5 in plasma from the start of dosing to the time of the last quantifiable (<LLOQ) sample following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||uM*hr||95% Confidence Interval|Geometric Mean
2560715|NCT02661126|Primary|Apparent Terminal Half-life in Plasma (t½) of Uprifosbuvir|t1/2 is the amount of time required to clear 50% of uprifosbuvir from plasma following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2560716|NCT02661126|Primary|Apparent Volume of Distribution (Vz/F) of Uprifosbuvir|Vz/F is the apparent volume of distribution of uprifosbuvir following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2560717|NCT02661126|Primary|Apparent Total Body Clearance (CL/F) of Uprifosbuvir|CL/F is the apparent total body clearance of uprifosbuvir following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||Liters/hour||Geometric Coefficient of Variation|Geometric Mean
2560718|NCT02661126|Primary|Time to Reach Maximum Plasma Concentration (Tmax) of Uprifosbuvir|Tmax is the time required to reach the maximum post-dose plasma concentration of uprifosbuvir following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis|||Hours||Full Range|Median
2560719|NCT02661126|Primary|Plasma Concentration 24 Hours Post-dose (C24) of Uprifosbuvir|C24 is the plasma concentration of uprifosbuvir 24 hours following oral administration of MK-3682B.|24 hours post-dose|All Healthy Control participants are included in the analysis. Since >50% of participants in the Moderate RI group had C24 values <LLOQ, no data are presented for this group as per Merck policy.|||nM||Full Range|Median
2560720|NCT02661126|Primary|Maximum Plasma Concentration (Cmax) of Uprifosbuvir|Cmax is the maximum amount of uprifosbuvir in plasma following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||nM||95% Confidence Interval|Geometric Mean
2560721|NCT02661126|Primary|AUC From Dosing to 24 Hours Post-dose (AUC0-24) of Uprifosbuvir|AUC0-24 is a measure of total exposure to uprifosbuvir in plasma from dosing to 24 hours following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, and 24 hours post-dose|All participants are included in the analysis.|||uM*hr||95% Confidence Interval|Geometric Mean
2560722|NCT02661126|Primary|AUC From Dosing to Infinity (AUC0-∞) of Uprifosbuvir|AUC0-∞ is a measure of total exposure to uprifosbuvir in plasma from the start of dosing to infinity following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||uM*hr||95% Confidence Interval|Geometric Mean
2560723|NCT02661126|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Dosing to Time of Last Measurable Concentration (AUC0-last) of Uprifosbuvir (MK-3682)|AUC0-last is a measure of total exposure to uprifosbuvir in plasma from the start of dosing to the time of the last quantifiable (< lower limit of quantification [LLOQ]) sample following oral administration of MK-3682B.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 48, 72, 96, and 120 hours post-dose|All participants are included in the analysis.|||uM*hr||95% Confidence Interval|Geometric Mean
2560724|NCT02661061|Secondary|Depression Relapse Rate During Treatment and Follow-up Phase|Clinical outcomes are secondary in this pilot trial. The 24-item Hamilton Rating Scale for Depression (HRSD-24) was used to assess for the main clinical outcome, the relapse rate over six months. Criteria for relapse are ≥10 point increase in HRSD-24 compared to baseline score plus HRSD ≥16; in addition, increase in the HRSD should be maintained one week later (if indicated, additional follow-ups will be arranged). Hospital admission, and deliberate self-harm/suicide also constitute relapse. Relapse may also occur during the eight-week treatment phase and is captured here.|8 months||||Participants|||Count of Participants
2560725|NCT02661061|Primary|Completion Rate for Randomised Treatment Phase|The outcomes for this pilot trial are process outcomes, primarily rates of recruitment and retention. Thus, the completion rate for the randomised treatment phase is the primary outcome. The study is not designed to assess efficacy.|2 years|All randomised participants who received one infusion were analysed (intention to treat)|||Participants|||Count of Participants
2560726|NCT02660983|Secondary|Double Blind (DB) Phase: Change From Baseline in Executive Function Test (Korean Trail Making Test Elderly [K-TMT-e]) Score (LOCF) at Week 24|The trail making test (TMT) was an evaluation tool used to assess the cognitive function, especially for executive function. The K-TMT-e has two parts that are referred to as part A (component: serial numbers) and part B (component: serial numbers and days). The K-TMT-e was a timed test and the goal was to complete the tests accurately and as quickly as possible. Higher scores reveal greater impairment. K-TMT-e Score was measured as time taken by participants to complete goal. LOCF=last observation carried forward.|Baseline and Week 24|The FAS, LOCF, included all randomized participants who received at least one dose of study drug and had at least one postdose primary efficacy measurement. Number analyzed signifies participants who were evaluable at a particular part of study for this outcome measure.|||seconds||Standard Error|Least Squares Mean
2560727|NCT02660983|Secondary|Double Blind (DB) Phase: Change From Baseline in Mini-mental State Examination (MMSE) Score (LOCF) at Week 24|MMSE is a well-known, gold standard test for measuring the cognitive state of dementia participants. It includes items evaluating orientation to time and place, recall of objects, attention, language, and conversational abilities. The total score ranges from 0 (most impaired) to 30 (no impairment). The lower score means severe cognitive deficit. A positive change score indicated improvement from baseline. LOCF=last observation carried forward.|Baseline and Week 24|The FAS, LOCF, included all randomized participants who received at least one dose of study drug and had at least one postdose primary efficacy measurement. Overall number of participants analyzed included participants who were evaluable at a particular time point for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2560752|NCT02660827|Secondary|Age 7-13 Years Old Subjects Mean Change in % of Time in Hypoglycemia (<70 mg/dL)|mean change in % of time in hypoglycemia (< 70 mg/dL) from baseline to 3 months treatment period|baseline and 3 months|7-13 years old subjects wearing MMT-670G insulin pump, participating in clinical evaluation of the suspend before low feature.|||percent of time||Standard Deviation|Mean
2560728|NCT02660983|Primary|Double Blind (DB) Phase: Clinicians Interview-based Impression of Change-plus Caregiver Input (CIBIC-plus) Score (LOCF)|"The CIBIC-plus rates change in global functioning relative to baseline on a scale. The score ranges from 1 (Marked improvement) to 7 (Marked worsening). A score of 4 represents no change from baseline. LOCF=last observation carried forward."|Week 24|The FAS, LOCF, included all randomized participants who received at least one dose of study drug and had at least one postdose primary efficacy measurement. Overall number of participants analyzed included participants who were evaluable at a particular time point for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2560729|NCT02660983|Primary|Double Blind (DB) Phase: Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score (LOCF) at Week 24|The ADAS-Cog was a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). The ADAS-cog scores range from 0 to 70, with negative change from baseline indicating clinical improvement. LOCF=last observation carried forward.|Baseline and Week 24|The FAS, LOCF, included all randomized participants who received at least one dose of study drug and had at least one postdose primary efficacy measurement. Overall number of participants analyzed included participants who were evaluable at a particular time point for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2560730|NCT02660918|Secondary|Time Between Recovery Initiation and Discharge|Time between arrival to the recovery room after surgery and discharge to home|hours between recovery initiation and discharge||||hours||Standard Deviation|Mean
2560731|NCT02660918|Secondary|Postoperative Anti-emetic|Data was collected on any nausea medicine administered following the endometrial ablation.|Postoperative||||Participants|||Count of Participants
2560732|NCT02660918|Secondary|Postoperative Toradol|Data was collected on whether or not the patient received Toradol following the endometrial ablation. Toradol is a non-narcotic pain medication.|Postoperative||||Participants|||Count of Participants
2560733|NCT02660918|Secondary|Postoperative Opioid Administered Following the Procedure But Prior to Discharge.|Narcotic medications administered in the recovery area before the patient was discharged from the Surgicenter.|Predischarge from hospital||||Participants|||Count of Participants
2560734|NCT02660918|Secondary|Postoperative Complication|Any unanticipated complication related to the endometrial ablation.|1 Day Postoperative||||Participants|||Count of Participants
2560735|NCT02660918|Secondary|Occurrence of Intraoperative Complication|This represents any unanticipated complication related to the endometrial ablation.|During Surgery||||Participants|||Count of Participants
2560736|NCT02660918|Primary|Remaining Tylenol Tablets With Codeine Not Taken at the End of Day 1 Following Discharge|All patients were given 10 tablets of Tylenol with codeine upon discharge for pain. This Outcome measure details the remaining number of tablets after day 1.|Postoperative|Data was only available for 38 patients in the Control group and 38 patients in the Treatment group|||Pills||Standard Deviation|Mean
2560737|NCT02660918|Primary|Intraoperative Total Blood Loss|Amount of operative blood lost measured in milliliters|Intraoperative|Data was only available for 37 patients in the Control group and 33 patients in the Treatment group|||cc||Standard Deviation|Median
2560738|NCT02660918|Primary|Postoperative Pain Score|"Pain will be assessed using a 10 point visual analog scale. On the scale 0 represented no pain and 10 represented the highest pain level. Eligibility for analgesia was available for patients who reported pain higher than 5 out of 10 on the scale.~Pain levels were assessed by trained nursing staff blinded to the study. Lower numbers on the 10 point scale represented a positive outcome.~Patients"|Immediate postoperatively through 8 hours post operation.|not avaialble|||units on a scale||Standard Deviation|Mean
2560739|NCT02660853|Secondary|Exhaled Hydrogen Sulphide||Baseline Visit, 12 months|Data were not collected||||||
2560740|NCT02660853|Secondary|Exhaled Nitric Oxide||Baseline Visit, 12 months|Data were not collected||||||
2560741|NCT02660853|Secondary|Corticosteroid Insensitivity in Peripheral Blood Mononuclear Cells||Baseline Visit, 12 months|No data collected||||||
2560742|NCT02660853|Secondary|Sputum Microbiome||Baseline Visit, 12 months|No data collected||||||
2560743|NCT02660853|Secondary|PCR for Respiratory Viruses|nasopharyngeal swabs|Baseline Visit, 12 months|No data collected||||||
2560744|NCT02660853|Secondary|Sputum Analysis|Eosinophils as percentage of total count|From baseline visit and 12 months|Severe asthma at baseline|||Percentage of total sputum counts||Standard Deviation|Mean
2560745|NCT02660853|Secondary|Markers of Oxidative Stress in Urine|8-isoprostanes|Baseline Visit, 12 months||2020-02-29|02/2020||||
2560746|NCT02660853|Secondary|Markers of Oxidative Stress in Urine|malondialdehyde (MDA)|Baseline Visit, 12 months||2020-02-29|02/2020||||
2560747|NCT02660853|Secondary|Exhaled Breath Condensate|pH and free Iron|Baseline Visit, 12 months|No data collected||||||
2560748|NCT02660853|Primary|Percent Predicted FEV1|From date of screening visit until date of first asthma exacerbation visit Percent predicted Forced Expiratory Volume in First Second|Baseline Visit, 12 months||||% of predicted value||Standard Deviation|Mean
2560749|NCT02660827|Secondary|Age 7-13 Years Old Subjects PLGM Performance - Event Rate Without Hypoglycemia at YSI-FST <=65 mg/dL|Event rate without Hypoglycemia at YSI-FST <=65 mg/dL among 105 subjects who underwent the PLGM experiments. The event rate without hypoglycemia is the number of experiments without hypoglycemia/total number of experiments and hypoglycemic events are defined based on the occurrence of 2 or more continuous YSI-FST <= 65mg/dL during in-clinic procedures.|Up to 12 hours after the start of PLGM period|7-13 years old subjects wearing MMT-670G insulin pump, participating in clinical evaluation of the suspend before low feature.|||percentage of total experiments|||Number
2560750|NCT02660827|Secondary|Age 7-13 Years Old - Number of Diabetic Ketoacidosis (DKA) Event|Number of Diabetic Ketoacidosis (DKA) events occurred during 3-month treatment period.|3 months|7-13 years old subjects wearing MMT-670G insulin pump, participating in clinical evaluation of the suspend before low feature.|||events|||Number
2560751|NCT02660827|Secondary|Age 7-13 Years Old - Number of Severe Hypoglycemic Event|Number of severe hypoglycemic events occurred during 3-month treatment period.|3 months|7-13 years old subjects wearing MMT-670G insulin pump, participating in clinical evaluation of the suspend before low feature.|||events|||Number
2560753|NCT02660827|Secondary|Age 7-13 Years Old Subjects Mean Change in % of Time in Hyperglycemia (> 180 mg/dL)|mean change in % of time in hyperglycemia (> 180 mg/dL) from baseline to 3 months treatment period|baseline and 3 months|7-13 years old subjects wearing MMT-670G insulin pump, participating in clinical evaluation of the suspend before low feature.|||Percent of time||Standard Deviation|Mean
2560754|NCT02660827|Secondary|Age 7-13 Years Old Subjects Mean Change in % of Time in Euglycemia (70-180 mg/dL)|mean change in % of time in Euglycemia (70-180 mg/dL) from baseline to 3 months treatment period|baseline and 3 months|7-13 years old subjects wearing MMT-670G insulin pump, participating in clinical evaluation of the suspend before low feature.|||Percentage of time||Standard Deviation|Mean
2560755|NCT02660827|Primary|Age 7-13 Years Old Subjects Change in A1C|Descriptive analysis of change in A1C from baseline to end of 3-month treatment period|Baseline and end of 3-month treatment period|7-13 years old subjects wearing MMT-670G insulin pump, participating in clinical evaluation of the suspend before low feature.|||percentage of hemoglobin||Standard Deviation|Mean
2560756|NCT02660801|Primary|Muscular Response, Inferior Level Ratio, Normalized RMS|To assess the muscular response during therapeutic modalities, the resulting bipolar sEMG signals were first digitally band-pass filtered using a frequency bandwidth of 20-450 Hz (2nd order Butterworth filter). For SMa, the peak root mean square (RMS) value was computed for each electrode using a 250 ms window (125 ms before and 125 ms after the peak force). The RMS values obtained for each electrode were then normalized (nRMS) to the respective RMS value calculated during the sEMG normalization trial.|During the spinal manipulation and mobilization||||ratio||Standard Deviation|Mean
2560757|NCT02660801|Primary|Muscular Response, Superior Level Ratio|To assess the muscular response during therapeutic modalities, the resulting bipolar sEMG signals were first digitally band-pass filtered using a frequency bandwidth of 20-450 Hz (2nd order Butterworth filter). For SMa, the peak root mean square (RMS) value was computed for each electrode using a 250 ms window (125 ms before and 125 ms after the peak force). The RMS values obtained for each electrode were then normalized (nRMS) to the respective RMS value calculated during the sEMG normalization trial.|During the spinal manipulation and mobilization||||ratio||Standard Deviation|Mean
2560758|NCT02660801|Primary|Pressure Provoked Pain|Pressure provoked pain intensity was assessed immediately after each spinal stiffness assessment using a 0 to 100 visual analog pain scale minimum value=0, maximum value=100. 0 is no pain while 100 is the worse outcome|immediately after the therapeutic modality application||||score on a scale||Standard Deviation|Mean
2560759|NCT02660801|Primary|Terminal Spinal Stiffness|Terminal stiffness was defined as the ratio of the variation of force and displacement between 10 and 45 N|two-minutes before spinal mobilization delivery up to two-minutes after||||N/mm||Standard Deviation|Mean
2560760|NCT02660801|Primary|Global Spinal Stiffness|Global stiffness was defined as the slope of the straight-line best fitting the force-displacement data between 10 and 45 N|two-minutes before spinal manipulation delivery up to two-minutes after||||N/mm||Standard Deviation|Mean
2560761|NCT02660580|Secondary|Observed Serum Concentration at Week 24 and 52|Observed serum concentrations at week 24 and 52 were reported.|Week 24 and 52|"The ETP-PK analysis included all participants in ETP SAF who had at least 1 measurable post-dose concentration in ETP, without any important protocol deviations that could have impacted quality of PK data during ETP. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified time points."|||ng/mL||Standard Deviation|Geometric Mean
2560762|NCT02660580|Secondary|Observed Serum Concentration at Week 16|Observed serum concentrations at week 16 were reported.|Week 16|"The Pharmacokinetic (PK) Analysis Set included all participants in the SAF who also had at least 1 measurable post-dose concentration. Here Number of Participants analyzed signifies those who were evaluable for this outcome measure."|||Nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2560763|NCT02660580|Secondary|Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52|Anti-Drug Antibodies (ADAs) Titers for adalimumab at Week 24, 32, 40 and 50 was reported. Data was collected using validated bioanalytical method.|Week 24, 32, 40 and 52|"ETP-SAF analysis set was used. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified category."|||Titers||Full Range|Median
2560764|NCT02660580|Secondary|Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 16|Anti-Drug Antibodies (ADAs) Titers for adalimumab at week 16 was reported. Data was collected using validated bioanalytical method.|Week 16|"SAF analysis set was used. Here Number of Participants analyzed signifies those who were evaluable for this outcome measure."|||Titers||Full Range|Median
2560765|NCT02660580|Secondary|Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52|Number of participants With positive treatment emergent Anti-Drug Antibodies (ADAs) and positive Neutralizing Antibodies (NAbs) to Adalimumab were reported. Data was collected using validated bioanalytical method.|Week 24, 32, 40 and 52|"ETP-SAF analysis set was used. Here Number analyzed signifies participants who were evaluable for this outcome measure at specified category."|||Participants|||Count of Participants
2560766|NCT02660580|Secondary|Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 16|Number of participants with treatment emergent Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab were reported from baseline to week 16. Data was collected using validated bioanalytical method.|Week 16|"SAF analysis set was used. Here Number of participants analyzed signifies those who were evaluable for this outcome measure and Number analyzed signifies those participants who were evaluable for this outcome measure at specified category."|||Participants|||Count of Participants
2560767|NCT02660580|Secondary|Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 24 and 52|Patient global assessment for joints was measured on a 100 millimeter (mm) VAS scale, where 0 = no pain and 100 = worst possible pain.|Week 24 and 52|"ETP-PP analysis set was used. Here Number analyzed signifies participants who were evaluable for this outcome measure at specified category."|||mm||Standard Deviation|Mean
2560768|NCT02660580|Secondary|Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 16|Patient global assessment for joints was measured on a 100 millimeter (mm) VAS scale, where 0 = no pain and 100 = worst possible pain.|Week 16|"PP analysis set was used. Here Number of participants analyzed signifies participants who were evaluable for this outcome measure at specified category."|||millimeter (mm)||Standard Deviation|Mean
2560769|NCT02660580|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24, and 52|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Week 24 and 52|"ETP-PP analysis set was used. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified category."|||Units on a scale||Standard Deviation|Mean
2560770|NCT02660580|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 16|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Week 16|"PP analysis set was used. Here Number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Units on a scale||Standard Deviation|Mean
2560771|NCT02660580|Secondary|European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 24 and 52|The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level on a visual analog scale, where the participant was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state.|Week 24 and 52|"ETP-PP analysis set was used. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified category."|||Units on a scale||Standard Deviation|Mean
2560772|NCT02660580|Secondary|European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on Visual Analogue Scale (VAS) Score at Week 16|The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level on a visual analog scale, where the participant was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state.|Week 16|"PP analysis set was used. Here Number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Units on a scale||Standard Deviation|Mean
2560773|NCT02660580|Secondary|European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 24 and 52|The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The responses are converted into a single index value, with scores ranging from -0.594 to 1 (a higher score indicates better health state).|Week 24 and 52|"ETP-PP analysis set was used. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified category."|||Units on a scale||Standard Deviation|Mean
2560774|NCT02660580|Secondary|European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 16|The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The responses are converted into a single index value, with scores ranging from -0.594 to 1 (a higher score indicates better health state).|Week 16|"PP analysis set was used. Here Number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Units on a scale||Standard Deviation|Mean
2560775|NCT02660580|Secondary|Dermatology Life Quality Index (DLQI) at Week 24 and 52|The DLQI is a 10-item validated quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI measures how much participant's skin problems has affected his life. Responses range from 0=Not at all to 3=Very much. The DLQI total score is the sum of individual 10 items and could range from 0 to 30 (higher score indicated greater negative impact on life).|Week 24 and 52|"ETP-PP analysis set was used. Here Number analyzed signifies number of participants who were evaluable for this outcome measure at specified category."|||Units on a scale||Standard Deviation|Mean
2560776|NCT02660580|Secondary|Dermatology Life Quality Index (DLQI) at Week 16|The DLQI is a 10-item validated quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI measures how much participant's skin problems has affected his life. Responses range from 0=Not at all to 3=Very much. The DLQI total score is the sum of individual 10 items and could range from 0 to 30 (higher score indicated greater negative impact on life).|Weeks 16|PP analysis set was used.|||Units on a scale||Standard Deviation|Mean
2560777|NCT02660580|Secondary|Number of Participants With Clinically Significant Abnormalities in 12-Electrocardiogram (12-ECG)|Number of participants with clinically significant abnormalities in 12-ECG were reported. Clinical significance was determined by the investigator.|Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54|Safety analysis set was used for Core Treatment Period. ETP-SAF was used for Extended Treatment Period.|||Participants|||Count of Participants
2560778|NCT02660580|Secondary|Number of Participants With Clinically Meaningful Differences in Vital Signs|Number of participants with clinically meaningful abnormalities in vital signs were reported. Clinical meaningful was determined by the investigator.|Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54|Safety analysis set was used for Core Treatment Period. ETP-SAF was used for Extended Treatment Period.|||Participants|||Count of Participants
2560779|NCT02660580|Secondary|Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52|Number of participants ANA and anti-ds DNA values were reported. For ANA, positivity is defined as any participants with ANA titer greater than (>) 1:160 and negativity is defined as ANA titer less than (<) 1:160. For anti-ds DNA, positivity is defined as any participants with adsDNA > 15 units per milliliter (U/mL), intermediate category is defined as value between 10 U/mL to 15 U/mL and negativity is defined as adsDNA < 10 U/mL.|Week 24, 32, 40 and 52|"ETP-SAF included all re-randomized participants who received at least 1 dose of MSB11022 or EU-approved Humira in ETP. Here Number of participants analyzed signifies those participants who were evaluable for this outcome measure & Number analyzed signifies those participants who were evaluable for this outcome measure for specified categories."|||Participants|||Count of Participants
2560780|NCT02660580|Secondary|Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16|Number of participants ANA and anti-ds DNA values were reported. For ANA, positivity is defined as any participants with ANA titer greater than (>) 1:160 and negativity is defined as ANA titer less than (<) 1:160. For anti-ds DNA, positivity is defined as any participants with adsDNA > 15 units per milliliter (U/mL), intermediate category is defined as value between 10 U/mL to 15 U/mL and negativity is defined as adsDNA < 10 U/mL.|Week 16|Safety analysis set was used.|||Participants|||Count of Participants
2560781|NCT02660580|Secondary|Number of Participants With Clinically Meaningful Differences in Laboratory Values|Based on categories of low, normal, or high according to the laboratory normal ranges, there were no clinically meaningful differences across the treatment groups in the numbers of participants with shifts in Laboratory parameters including hematology, chemistry and urinalysis from normal at Core Baseline to either low or high during the overall treatment period. Clinical meaningful was determined by the investigator.|Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54|Safety Analysis Set (SAF) was used for up to Week 16. The ETP-SAF was used in Extended Treatment Period.|||Participants|||Count of Participants
2560782|NCT02660580|Primary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI 75) at Week 16|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI-75 response is defined as the percentage of participants who achieved at least a 75% improvement in PASI score from Baseline.|Week 16|The per-protocol (PP) Analysis Set included all randomized and treated participants who did not have any major protocol deviations during the Core Treatment Period with respect to factors likely to affect the efficacy of treatment.|||Percentage of Participants|||Number
2560783|NCT02660580|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54|Adverse event(AE) was defined as any untoward medical occurrence in participants which does not necessarily have causal relationship with treatment. AE was any unfavorable and unintended sign(including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal product, whether/not considered related to medicinal product. A serious adverse event(SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Term TEAE is defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs.|Baseline (Day 1 of Extended Treatment Period) up to Week 54|ETP-SAF Analysis Set was used. Participants were analyzed according to actual treatment received initially during the relevant treatment period.|||Participants|||Count of Participants
2560784|NCT02660580|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16|Adverse event(AE) was defined as any untoward medical occurrence in participants which does not necessarily have causal relationship with treatment. AE was any unfavorable and unintended sign(including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal product, whether/not considered related to medicinal product. A serious adverse event(SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Term TEAE is defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs.|Baseline (Day 1 of Core Treatment Period) up to Week 16|Safety (SAF) Analysis Set included all randomized participants who received at least 1 dose of MSB11022 or EU-Humira. Participants in SAF were analyzed according to actual treatment received initially during the relevant treatment period.|||Participants|||Count of Participants
2560785|NCT02660580|Secondary|Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52|PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).|Baseline (Day 1 of Extended Treatment Period), Week 52|"ETP-PP Analysis set was used. Here Number of participants analyzed signifies those who were evaluable for this outcome measure. Only categories for which participants recorded a PGA response were included below."|||Participants|||Count of Participants
2560808|NCT02660242|Secondary|Number of Participants With Hyperglycemia (≥250 mg/dL) During Exercise and Early Recovery|Comparison of occurrence of hyperglycemia (≥250 mg/dL from blood glucose) during exercise and early recovery between each exercise strategy.|0 to 75 minutes following exercise initiation||||Participants|||Count of Participants
2561407|NCT02650921|Secondary|Responder Rate Using Validated Hand Grading Scale|A responder is defined as a hand with at least one point improvement from baseline|16 weeks|ITT|||Participants|||Count of Participants
2560786|NCT02660580|Secondary|Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24|PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).|Baseline (Day 1 of Extended Treatment Period), Week 24|"ETP-PP Analysis set was used. Only categories for which participants recorded a PGA response were included below. Here Number of participants analyzed signifies those who were evaluable for this outcome measure."|||Participants|||Count of Participants
2560787|NCT02660580|Secondary|Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16|PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).|Baseline (Day 1 of Core Treatment Period), Week 16|PP Analysis set was used. Only categories for which participants recorded a PGA response were included below.|||Participants|||Count of Participants
2560788|NCT02660580|Secondary|Time to Achieve PASI 100|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 100% improvement in PASI from baseline was measured.|Baseline (Day 1 of Core Treatment Period) up to Month 13.5|ETP-PP analysis set was used.|||Month||Full Range|Median
2560789|NCT02660580|Secondary|Time to Achieve PASI 90|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 90% improvement in PASI from baseline was measured.|Baseline (Day 1 of Core Treatment Period) up to Month 4|PP analysis set was used.|||Months||Full Range|Median
2560790|NCT02660580|Secondary|Time to Achieve PASI 75|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 75% improvement in PASI from baseline was measured.|Baseline (Day 1 of Core Treatment Period) up to Month 4|PP analysis set was used.|||Months||Full Range|Median
2560791|NCT02660580|Secondary|Time to Achieve PASI 50|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 50% improvement in PASI from baseline was measured.|Baseline (Day 1 of Core Treatment Period) up to Month 4|PP analysis set was used.|||Months||Full Range|Median
2560792|NCT02660580|Secondary|"Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52"|PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).|Baseline (Day 1 of Extended Treatment Period), Week 24 and 52|"ETP-PP Analysis set was used. Here Number analyzed indicates number of participants who were evaluable for this outcome measure at specified category. Number of participants with PGA response of Clear or Almost clear at Week 24 and 52 were presented."|||Participants|||Count of Participants
2560793|NCT02660580|Secondary|"Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 16"|PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates Clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal [focal] scaling), 2 indicates Mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates Moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates Severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).|Baseline (Day 1 of Core Treatment Period), Week 16|PP Analysis set was used. Number of participants with PGA response of Clear or Almost clear at Week 16 were presented.|||Participants|||Count of Participants
2560836|NCT02658877|Other Pre-specified|The Effect of Omalizumab on Newly Identified sHBEC Targets (Gene Expression) Analyzed Using Gene Analyses||16 Weeks of Treatment of omalizumab or placebo|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2560794|NCT02660580|Secondary|Percent Change From Baseline in PASI at Week 24 and 52|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity.|Baseline (Day 1 of Extended Treatment Period), Weeks 24 and 52|"The ETP-PP analysis set was used. Here Number analyzed Signifies those participants who were evaluable for this outcome measure at specified time points."|||Percent change||Standard Deviation|Geometric Mean
2560795|NCT02660580|Secondary|Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI response rate at Week 52 is measured as the percentage of participants who achieved at least 50, 75, 90 and 100% improvement from baseline PASI at Week 52.|Week 52|"The ETP-PP Analysis Set was used. Here Number of participants analyzed signifies those who were evaluable for this outcome measure."|||Percentage of Participants|||Number
2560796|NCT02660580|Secondary|Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI response rate at Week 24 is measured as the percentage of participants who achieved at least 50, 75, 90 and 100% improvement from baseline PASI at Week 24.|Week 24|"The Extended Treatment Period (ETP)-PP Analysis Set included participants who were in PP Analysis Set & were re-randomized & received treatment in Extended Treatment Period. Here Number of participants analyzed signifies those who were evaluable for this outcome measure."|||Percentage of Participants|||Number
2560797|NCT02660580|Secondary|Percentage of Participants Who Achieved PASI 50, 90 and 100 at Week 16|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI 50, 90 and 100 response rate at Week 16 is measured as the percentage of participants who achieved at least 50, 90 and 100% improvement from baseline PASI score at Week 16.|Week 16|PP analysis set was used.|||Percentage of Participants|||Number
2560798|NCT02660580|Secondary|Percent Change From Baseline in PASI at Week 16|PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Percent change from Baseline in PASI score was reported.|Baseline (Day 1 of Core Treatment Period), Week 16|The PP Analysis set was used.|||Percent change||Standard Deviation|Mean
2560799|NCT02660242|Secondary|CGM Metrics During Late Recovery - Time > 250 mg/dL|Comparison of percentage of time > 250 mg/dL from CGM between the exercise strategies.|90 min after the standard meal until 1200 noon the day after each exercise session|Included data were limited to periods with at least 12 hours of CGM data|||percentage||Standard Deviation|Mean
2560800|NCT02660242|Secondary|CGM Metrics During Late Recovery - Time > 180 mg/dL|Comparison of percentage of time > 180 mg/dL from CGM between the exercise strategies.|90 min after the standard meal until 1200 noon the day after each exercise session|Included data were limited to periods with at least 12 hours of CGM data|||percentage||Standard Deviation|Mean
2560801|NCT02660242|Secondary|CGM Metrics During Late Recovery - Time in Range (70-180 mg/dL)|Comparison of percentage of time in range (70-180 mg/dL) from CGM between the exercise strategies.|90 min after the standard meal until 1200 noon the day after each exercise session|Included data were limited to periods with at least 12 hours of CGM data|||percentage||Standard Deviation|Mean
2560802|NCT02660242|Secondary|CGM Metrics During Late Recovery - Time < 70 mg/dL|Comparison of percentage of time < 70 mg/dL from CGM between the exercise strategies.|90 min after the standard meal until 1200 noon the day after each exercise session|Included data were limited to periods with at least 12 hours of CGM data|||percentage||Standard Deviation|Mean
2560803|NCT02660242|Secondary|CGM Metrics During Late Recovery - Time < 54 mg/dL|Comparison of percentage of time < 54 mg/dL from CGM between the exercise strategies.|90 min after the standard meal until 1200 noon the day after each exercise session|Included data were limited to periods with at least 12 hours of CGM data|||percentage||Standard Deviation|Mean
2560804|NCT02660242|Secondary|CGM Metrics During Late Recovery - Coefficient of Variation|Comparison of the coefficient of variation from CGM between the exercise strategies.|90 min after the standard meal until 1200 noon the day after each exercise session|Included data were limited to periods with at least 12 hours of CGM data|||percentage||Inter-Quartile Range|Median
2560805|NCT02660242|Secondary|CGM Metrics During Late Recovery - Mean Glucose|Comparison of mean glucose from CGM between the exercise strategies.|90 min after the standard meal until 1200 noon the day after each exercise session|Included data were limited to periods with at least 12 hours of CGM data.|||mg/dL||Inter-Quartile Range|Median
2560806|NCT02660242|Secondary|CGM Metrics During Late Recovery - Peak Glucose|Comparison of peak glucose from CGM between the exercise strategies.|90 min after the standard meal until 1200 noon the day after each exercise session|Included data were limited to periods with at least 12 hours of CGM data.|||mg/dL||Inter-Quartile Range|Median
2560807|NCT02660242|Secondary|Continuous Glucose Monitor (CGM) Metrics During Late Recovery - Nadir Glucose|Comparison of nadir glucose from CGM between the exercise strategies.|90 min after the standard meal until 1200 noon the day after each exercise session|Included data were limited to periods with at least 12 hours of CGM data.|||mg/dL||Inter-Quartile Range|Median
2560809|NCT02660242|Secondary|Number of Participants With Hypoglycemia (<70 mg/dL) During Exercise and Early Recovery|Comparison of occurrence of hypoglycemia (<70 mg/dL from blood glucose) during exercise and early recovery between each exercise strategy.|0 to 75 minutes following exercise initiation||||Participants|||Count of Participants
2560810|NCT02660242|Primary|Glycemic Response During Exercise and Early Recovery|Comparison of glycemic response (from blood glucose) during exercise and early recovery between each exercise strategy.|0 to 75 minutes following exercise initiation (0, 5, 10, 15, 25, 35, 45, 50, 55, 60, 75 min)||||mg/dL||Standard Deviation|Mean
2560811|NCT02660229|Secondary|Investigator's Overall Satisfaction With IV Infusion on 5 Days After Randomization|The investigators made an assessment using the CGI-C on a 7-point scale (1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse).|5 days|"FAS set. However, OxyNorm 1 subject (S08-09) and Morphine sulfate 1 subject (S08-15) were not assessed on Day 5 after baseline.~So, the data was missed."|||Participants|||Count of Participants
2560812|NCT02660229|Secondary|Patient's Overall Satisfaction With Each Continuous Infusion on Day 5 After Randomization|The subjects made an assessment of overall treatment satisfaction regarding pain using the PGI-C on a 7-point scale (1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse) after baseline and at the end of the study (Day 5).|5 days|FAS set. However, OxyNorm 1 subject (S08-09) and Morphine sulfate 1 subject (S08-15) were not assessed on Day 5 after baseline. So, missing data was excluded from analysis. Oxynorm group 32 subjects and Morphine group 31 subjects were analysed for PGIC.|||Participants|||Count of Participants
2560813|NCT02660229|Secondary|Total Dose of IV(IV Infusion+Bolus Injection) Study Drug Administered During the Treatment Duration|"The dose of the study drugs intravenously administered was checked and recorded every day. The information on the dose administered from baseline to each assessment time point was collected based on records on the chart, and in the event of dose change/end of treatment, pertinent date and time, and dose were recorded accurately on the chart.~‡ Total administered dose of the study drugs (mg)= IV infusion (mg/hr) * [(End date - start date) * 24 + (end time - start time)] + bolus injection (mg)"|5 days|FAS set.|||mg||Standard Deviation|Mean
2560814|NCT02660229|Primary|Change in the Mean Pain Score(NRS) From Baseline(Day 0) to Day 5.|"For the pain assessment value for efficacy assessment, Subjects perform pain grading through Numeric rating score(NRS) from 1 to 10 for the mean pain intensity over the past 7 days at Screening, and mean pain intensity over the past 24 hours at Baseline (Day 0), Day 1, Day 2, Day 3, Day 4, Day 5.~Verbal measurement can be conducted by subjects without using visual data. '0' indicates 'no pain', and as the number increases, the pain gets more severe, and '10' indicates the worst pain."|5 days|Primary endpoint was analysed FAS set.|||units on a scale||Standard Deviation|Mean
2560815|NCT02660112|Primary|Change in Ventricular Hypertrophy as Shown on Cardiac MRI|Left ventricular mass and left ventricular (LV) mass indexed to body surface area estimated by Left Ventricle (LV)cavity dimension and wall thickness at end-diastole. Normal values of LV mass indexed to body surface area are found to be 49-115 gL/m2 in men and 43-95 g/m2 in women.|Baseline, 24 weeks||||mL/m2||Standard Deviation|Mean
2560816|NCT02660112|Primary|Change From Baseline in Friedreich Ataxia Rating Scale (FARS) Composite Score|"The Friedreich Ataxia Rating Scale (FARS) is made up of a measure of ataxia, an activities of daily living subscale and a neurological subscale. This scale also includes the 8m walk at maximum speed (8MW), the 9-hole peg test (9HPT), PATA rate (assesses speech speed by repetitions of pronouncing PaTa ) and low-contrast letter acuity.~FARS is made up of a measure of ataxia, an activities of daily living subscale and a neurological subscale. This scale also includes the 8m walk at maximum speed (8MW), the 9-hole peg test (9HPT), PATA rate and low-contrast letter acuity. The scores from the three subscales are added to generate a total score ranging from 0 to 159, with a higher score indicating a greater level of disability."|Baseline, 24 weeks|One subject did not complete week 24 questionnaire|||score on a scale||Standard Deviation|Mean
2560817|NCT02659787|Primary|"Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire Subjective Response With and Without Buprenorphine"|"The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: Feel Drug, Feel High, and Want More. The Feel Drug, Feel High, Like Drug, and Want More subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0 -100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome."|0 through 3 hours after dosing.||||units on a scale||Standard Error|Mean
2560818|NCT02659709|Secondary|Use of Medication Reminder|Responses collected from participants about use of medication reminders for their glaucoma drops obtained by completing a 20 item questionnaire.|1 hour|Participants responding Yes to using their glaucoma eye drops as prescribed without reminders.|||Participants|||Count of Participants
2560819|NCT02659709|Secondary|Glaucoma Medication Compliance|Responses collected from participants about compliance to using their glaucoma drops as prescribed obtained by completing a 20 item questionnaire.|1 hour|Participants responding Yes using their glaucoma eye drops as prescribed.|||Participants|||Count of Participants
2560820|NCT02659709|Primary|Patients Having Access to Social Media Via Smartphone or Tablet in the Home|Responses collected from participants about their personal access, through other members in the home, to social media via smartphone or tablet technology obtained by completing a 20 item questionnaire.|1 hour|Participants responding Yes to anyone in the house owning a smartphone or tablet.|||Participants|||Count of Participants
2560821|NCT02659709|Primary|Patients Owning Smartphone/Tablet Technology|Responses collected from participants about owning access to social media via smartphone or tablet technology obtained by completing a 20 item questionnaire.|1 hour|Participants responding Yes to owning a smartphone or tablet.|||Participants|||Count of Participants
2560822|NCT02659540|Secondary|Overall Survival|Overall survival (OS) will be measured for each subject from the date of the first dose of study drug until the recorded date of death or last follow-up. Subjects who are still alive will be censored on the date of last follow-up. Every effort will be made to follow subjects for OS after they discontinue the study.|Up to 3 years post-study||2020-12-31|12/2020||||
2560837|NCT02658877|Other Pre-specified|The Effect of Omalizumab on Newly Identified sHBEC Targets (Gene Expression) Analyzed Using Cufflinks.||16 Weeks of Treatment of omalizumab or placebo|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2560823|NCT02659540|Secondary|Progression-free Survival|Progression-free survival will be defined as the number of days from the date of first dose of study drug to the date of earliest disease progression or to the date of death, if disease progression does not occur. Subjects who do not progress and are still alive will be censored on the date of last follow-up or start of new treatment, whichever comes first. Every effort will be made to follow subjects for progression after they discontinue the study.|Up to 3 years post-study||2020-12-31|12/2020||||
2560824|NCT02659540|Secondary|Duration of Response|Duration of response will be determined for each subject with time origin at the first occurrence of response until the first occurrence of progression or date of death if the subject dies due to any causes before progression. Every effort will be made to follow subjects for progression after they discontinue the study.|Up to 3 years post-study||2020-12-31|12/2020||||
2560825|NCT02659540|Secondary|Number of Subjects With Tumor Response at Week 18 by irRECIST|Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), at Weeks 12, 18, and 24, and every 12 weeks (± 7 days) thereafter until progression or start of alternate anticancer therapy. Per irRECIST, measurable lesions are categorized as follows: irCR: Complete disappearance of all target lesions; irPR: ≥ 30% decrease from baseline in the TMTB; irPD: ≥ 20% increase from nadir in TMTB; irSD: not meeting above criteria (Bohnsack et al. Ann Oncol 2014;25: iv361-iv72).|18 weeks|The population comprises all subjects who received at least one dose of study treatment and had a Week 18 imaging assessment.|||Participants|||Count of Participants
2560826|NCT02659540|Secondary|Number of Subjects With Tumor Response at Week 12 by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)|Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), at Weeks 12, 18, and 24, and every 12 weeks (± 7 days) thereafter until progression or start of alternate anticancer therapy. Per irRECIST, measurable lesions are categorized as follows: irCR: Complete disappearance of all target lesions; irPR: ≥ 30% decrease from baseline in the total measurable tumor burden (TMTB); irPD: ≥ 20% increase from nadir in TMTB; irSD: not meeting above criteria (Bohnsack et al. Ann Oncol 2014;25: iv361-iv72).|12 weeks|The population comprises all subjects who received at least one dose of study treatment and had a Week 12 imaging assessment.|||Participants|||Count of Participants
2560827|NCT02659540|Secondary|Number of Subjects With Tumor Response at Week 18 by RECIST 1.1|Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 28 days before the first dose of study treatment), at Weeks 12, 18, and 24, and every 12 weeks (± 7 days) thereafter until progression or start of alternate anticancer therapy. Per RECIST 1.1, target lesions are categorized as follows: CR: Disappearance of all target lesions; PR: ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions; SD: small changes that do not meet above criteria (Eisenhauer et al. Eur J Cancer 2009;45:228-47).|18 weeks|The population comprises all subjects who received at least one dose of study treatment and had a Week 18 imaging assessment.|||Participants|||Count of Participants
2560828|NCT02659540|Secondary|Number of Subjects With Tumor Response at Week 12 by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 28 days before the first dose of study treatment), at Weeks 12, 18, and 24, and every 12 weeks (± 7 days) thereafter until progression or start of alternate anticancer therapy. Per RECIST 1.1, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria (Eisenhauer et al. Eur J Cancer 2009;45:228-47).|12 weeks|The population comprises all subjects who received at least one dose of study treatment and had a Week 12 imaging assessment.|||Participants|||Count of Participants
2560829|NCT02659540|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs)|Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent was signed through 100 days after the last dose of study treatment. Treatment-emergent AEs were those that occurred or worsened after administration of the first dose of study treatment.|Up to 25 months|The population comprises all subjects who received at least one dose of study treatment.|||Participants|||Count of Participants
2560830|NCT02659501|Primary|The Effect of Liposomal Bupivacaine on Length of Hospital Stay|Length of hospital stay will be determined for patients in each group, in total hours.|24-60 hours||||hrs||Standard Deviation|Mean
2560831|NCT02659501|Primary|The Effect of Liposomal Bupivacaine on Postoperative Diazepam Consumption|Benzodiazepine consumption, in mg of diazepam, was recorded for all patients and compared over the first 24 hours post-operatively.|24 hours||||mg of diazepam/hr||Standard Deviation|Mean
2560832|NCT02659501|Primary|The Effect of Liposomal Bupivacaine on Postoperative Opioid Consumption|Postoperative opioid consumption will be determined in each group. Opioid consumption post-operatively will be determined for patients in each group in standardized units of morphine milligram dosing equivalents per hour.|24 hours||||Morphine equivalent dosage per hour||Standard Deviation|Mean
2560833|NCT02659501|Primary|The Effect of Liposomal Bupivacaine on Antiemetic Consumption|The effect of liposomal bupivacaine on antiemetic consumption was assessed in mg of ondansetron consumed over first 24 hours post-operatively.|24 hours||||mg of ondansetron||Standard Deviation|Mean
2560834|NCT02659501|Primary|The Effect of Liposomal Bupivacaine on Average Postoperative Pain Levels on Postoperative Day 1.|Postoperative pain levels were determined with a numeric rating scale (NRS), rating pain from 0 - 10, where 0 = no pain, 10 = worst possible pain. Higher scores indicate a worse outcome. Pain levels were determined during routine vital signs every 4 hours post-operatively.|Average Pain Scores 24 hours Post-Operatively||||Pain Level||Standard Deviation|Mean
2560835|NCT02658877|Other Pre-specified|"The Effect of Omalizumab on Gene Signature Generation Analyzed Using Gene Analysis Techniques"||16 Weeks of Treatment of omalizumab or placebo|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2560842|NCT02658877|Primary|Measurement in the Reduction of the Effect of Omalizumab on IL-33 Gene Expression Using Nonparametric Wilcoxon in sHBEC in Moderate Persistent Asthma||16 Weeks of Treatment of omalizumab or placebo|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2560843|NCT02658877|Primary|Measurement in the Reduction of the Effect of Omalizumab on IL-33 Gene Expression Using Two Group T-test in Moderate Persistent Asthma||16 Weeks of Treatment of omalizumab or placebo|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2560844|NCT02658877|Primary|Measurement in the Reduction of the Effect of Omalizumab on Thymic Stromal Lymphopoietin (TSLP) Using Nonparametric Wilcoxon in sHBEC in Moderate Persistent Asthma||16 Weeks of Treatment of omalizumab or placebo|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2560845|NCT02658877|Primary|Measurement in the Reduction of the Effect of Omalizumab on Thymic Stromal Lymphopoietin (TSLP) Using Two Group T-test in Moderate Persistent Asthma||16 Weeks of Treatment of omalizumab or placebo|Most (n=124) of these patients failed screening criteria and investigator did not move forward||||||
2560846|NCT02658461|Secondary|Total Participant Time Per Episode of Care Spent in the Chair for Administration of Trastuzumab|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Start and stop 'chair' times were recorded to determine the total time spent in the treatment chair during a single episode of care. The average time spent in the chair per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample|||minutes|Participants|Standard Deviation|Mean
2560847|NCT02658461|Secondary|Total Participant Time Per Episode of Care Spent in the Care Unit for Administration of Trastuzumab|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Arrival and discharge times were recorded to determine the total time spent in the care unit during a single episode of care. The average time spent in the care unit per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample|||minutes|Participants|Standard Deviation|Mean
2560848|NCT02658461|Secondary|Number of Consumable Medical Supplies Used Per Episode of Care in the Preparation of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the preparation of trastuzumab IV infusion were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.|Data collection up to 1 year|Consumables Sample for Trastuzumab IV Infusion; number (n) of observations per item are shown.|||consumables|Participants|Standard Deviation|Mean
2560849|NCT02658461|Secondary|Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab IV infusion were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.|Data collection up to 1 year|Consumables Sample for Trastuzumab IV Infusion: All observations of an episode of care with trastuzumab IV infusion that utilized any of the recorded consumable supplies; number (n) of observations per item are shown.|||consumables|Participants|Standard Deviation|Mean
2560850|NCT02658461|Secondary|Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab SC Injection|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab SC injection were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.|Data collection up to 1 year|Consumables Sample for Trastuzumab SC Injection: All observations of an episode of care with trastuzumab SC injection that utilized any of the recorded consumable supplies; number (n) of observations per item are shown.|||consumables|Participants|Standard Deviation|Mean
2560851|NCT02658461|Secondary|Number of Consumable Medical Supplies Used Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. Consumable medical supplies used in the administration of trastuzumab single-use injection device were counted during a single episode of care. The average number of each type of consumable used per episode was calculated.|Data collection up to 1 year|Consumables Sample for Trastuzumab Single-Use Injection Device: All observations of an episode of care with trastuzumab single-use injection device that utilized any of the recorded consumable supplies; number (n) of observations per item are shown.|||consumables|Participants|Standard Deviation|Mean
2560852|NCT02658461|Secondary|Total HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the preparation of trastuzumab IV infusion was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample|||minutes|Participants|Standard Deviation|Mean
2560853|NCT02658461|Secondary|Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab IV infusion was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample|||minutes|Participants|Standard Deviation|Mean
2560854|NCT02658461|Secondary|Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab SC injection was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample|||minutes|Participants|Standard Deviation|Mean
2560875|NCT02658084|Secondary|Phase 2 - Objective Response Rate (ORR)|Rate of participants achieving a best overall response of complete response (CR) or partial response (PR) to protocol therapy according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 criteria.|Up to 5 Years|The Phase 2 arm did not open to accrual. No participants were enrolled to Phase 2.||||||
2560855|NCT02658461|Secondary|Total HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab single-use injection device was recorded during each episode of care. Total HCP time was determined by adding together the time spent on all tasks. The average total HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample|||minutes|Participants|Standard Deviation|Mean
2560856|NCT02658461|Secondary|Task-Specific HCP Time Required Per Episode of Care in the Preparation of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the preparation of trastuzumab IV infusion was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample; number (n) of observations per task are shown.|||minutes|Participants|Standard Deviation|Mean
2560857|NCT02658461|Secondary|Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab IV infusion was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample; number (n) of observations per task are shown.|||minutes|Participants|Standard Deviation|Mean
2560858|NCT02658461|Secondary|Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab SC Injection|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab SC injection was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample; number (n) of observations per task are shown.|||minutes|Participants|Standard Deviation|Mean
2560859|NCT02658461|Secondary|Task-Specific HCP Time Required Per Episode of Care in the Administration of Trastuzumab Single-Use Injection Device|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time spent on each pre-specified task in the administration of trastuzumab single-use injection device was recorded during each episode of care. The average task-specific HCP time per episode was calculated and expressed in minutes.|Data collection up to 1 year|Total Sample; number (n) of observations per task are shown.|||minutes|Participants|Standard Deviation|Mean
2560860|NCT02658461|Secondary|Monetary Cost of Health Care Resources Used Per Episode of Care in Preparation and Administration of Trastuzumab IV Infusion|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from NHS reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the preparation and administration of trastuzumab IV infusion during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.|Data collection up to 1 year|Total Sample|||pounds|Participants|Standard Deviation|Mean
2560861|NCT02658461|Primary|Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab SC Injection|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from NHS reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the administration of trastuzumab SC injection during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.|Data collection up to 1 year|Total Sample|||pounds|Participants|Standard Deviation|Mean
2560862|NCT02658461|Primary|Monetary Cost of Health Care Resources Used Per Episode of Care in Administration of Trastuzumab Single-Use Injection Device|The study observed 36 episodes of care (12 per study arm) to collect data on infusion/injection-related tasks. HCP time was estimated using hourly salary data from National Health Service (NHS) reference costs. Consumable supplies were costed using hospital pharmacy data and online sources. Analysis was limited to only those items with an individual cost of £0.05 or more. Monetary cost of health care resources was determined by adding the costs of consumable supplies and HCP time spent in the administration of trastuzumab single-use injection device during a single episode of care. The average monetary cost per episode was calculated and expressed in pounds.|Data collection up to 1 year|Total Sample: All observations of an episode of care for the given treatment route.|||pounds|Participants|Standard Deviation|Mean
2560863|NCT02658357|Secondary|Safety and Efficacy of a Risperidone Implant as Assessed by the Positive and Negative Syndrome Scale (PANSS)||12 months|The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.||||||
2560864|NCT02658357|Primary|Cmax for Active Moiety, 9-hydroxy-risperidone and Risperidone||6 months|The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.||||||
2560865|NCT02658357|Primary|Area Under the Curve (AUC) for Active Moiety, 9-hydroxy-risperidone and Risperidone||6 months|The product was sold to another company prior to data analysis. The new company closed before the results were completed, so no results are available for this study.||||||
2560866|NCT02658240|Secondary|The Time to Ambulation|The time to ambulation during 48 hours postoperative period|Postoperative 48 hours||||Hours||Inter-Quartile Range|Median
2560867|NCT02658240|Secondary|Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours|Total amounts of postoperative opioid requirements for 48 hours postoperatively|Postoperative 48 hours||||Oral Morphine Equivalent (mg)||Standard Deviation|Mean
2560868|NCT02658240|Primary|Postoperative Pain Score With Movement|The Visual Analog Pain Score (VAS) with movement on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively|Postoperative 48 hours||||units on a scale||Inter-Quartile Range|Mean
2561408|NCT02650921|Primary|Responder Rate Using Validated Hand Grading Scale|A responder is defined as a hand with at least one improvement from baseline.|12 Weeks|ITT population|||Participants|||Count of Participants
2560876|NCT02658084|Secondary|Phase 2 - Overall Survival (OS) Rate|Overall Survival (OS) is defined as the elapsed time from date from first treatment received on study to death or date of censoring. Patients alive or those lost to follow-up will be censored at the last date of contact (or last date known to be alive).|Up to 5 Years|The Phase 2 arm did not open to accrual. No participants were enrolled to Phase 2.||||||
2560877|NCT02658084|Secondary|Phase 2 - Clinical Benefit Rate (CBR)|Rate of participants achieving best overall response of complete response (CR), partial response (PR) or stable disease (SD) for >/= 6 months on protocol therapy, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria|Up to 5 years|The Phase 2 arm did not open to accrual. No participants were enrolled to Phase 2.||||||
2560878|NCT02658084|Primary|Phase 1 - Rate of Participants Experiencing Adverse Events|Rate of participants experiencing adverse events including dose-limiting toxicities (DLTs) and serious adverse events (SAEs).|18 months|For adverse events, participants who received at least one dose of study therapy. For dose-limiting toxicities, participants who experienced a dose-limiting toxicity during the first two cycles of study therapy.|||participants|||Number
2560879|NCT02658084|Primary|Phase 2 - Rate of Progression-Free Survival (PFS)|Rate of Progression-Free Survival (PFS) in participants receiving the RP2D of vinorelbine in combination with Trastuzumab Emtansine therapy. PFS is defined as the time from date from first treatment received on study until documented disease progression or death (by any cause, in the absence of progression). In progression-free patients, PFS will be censored at the last evaluable tumor assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.|Up to 5 years|The Phase 2 arm did not open to accrual. No participants were enrolled to Phase 2.||||||
2560880|NCT02658084|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Vinorelbine in Combination With a Fixed Dose of Trastuzumab Emtansine.|Identifying the Maximum Tolerated Dose (MTD) of Vinorelbine combined with a fixed dose of Trastuzumab Emtansine to be recommended for the phase II portion of the study (RP2D).|2 years|Approximately 15 to 21 participants would be needed to establish the recommended phase II dose (RP2D). Only 2 participants were enrolled therefore the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) were not determined.||||||
2560881|NCT02657928|Other Pre-specified|Molecular Biomarkers Associated With a Response to Treatment With Letrozole and Ribociclib|Whether response rates to letrozole and ribociclib in patient derived xenograft avatars correlate to responses noted in the patients will be determined. Fisher's Exact test will be used to measure the associations.|Baseline|||||||
2560882|NCT02657928|Other Pre-specified|Creation of Patient Derived Xenograft Models for Future Translational Experiments|Xenograft will be created on each patient. For patient derived xenograft experiments, response to therapy will be based on tumor volumes measured by ultrasound. Tumor growth curves will be plotted graphically and notated to indicate the outcome status of the originating patients. End of study tumor volumes will be correlated with outcome status of the originating patient as well.|28 days following treatment initiation|||||||
2560883|NCT02657928|Secondary|The Number of Treatment-related Grade 3 or Higher Adverse Events|The number of treatment-related Grade 3 or higher adverse events using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0|Up to 30 days post-treatment||||events|||Number
2560884|NCT02657928|Secondary|The Number of Patients With Confirmed Response (Complete Response or Partial Response)|The number of patients with confirmed response (complete response or partial response) using Response Evaluation Criteria in Solid Tumors version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 2 years||||Participants|||Count of Participants
2560885|NCT02657928|Secondary|The Number of Patients With CA-125 Response|The number of patients with CA-125 response, defined as a 50% or greater reduction in baseline CA-125.|Up to 2 years|Patients with CA-125 response data available with abnormal values at baseline are included in this analysis.|||Participants|||Count of Participants
2560886|NCT02657928|Secondary|Overall Survival|Overall survival time is defined as the time from registration to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|From registration to death from any cause, assessed up to 2 years||||months||95% Confidence Interval|Median
2560887|NCT02657928|Secondary|Progression-free Survival|Progression free survival (PFS) is defined as the time from the date of registration to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|From registration to the first of either disease progression or death from any cause, assessed up to 2 years||||months||95% Confidence Interval|Median
2560888|NCT02657928|Primary|Percentage of Patients Alive and Free of Progression at 12 Weeks (PFS12)|The percentage of patients who are progression-free at 12 weeks (PFS12) is defined as patients who are alive and progression free at 12 weeks. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|At 12 weeks|Per protocol analysis population: 19 evaluable patients per cohort|||percentage of patients|||Number
2560889|NCT02657915|Secondary|Change in Volume of T2 Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915)|Change in disease activity from baseline with brain magnetic MRI was calculated and reported. MRI analysis included volume of T2 lesions as disease activity.|Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)|The PP population was defined as participants from the ITT population who completed the study, did not miss more than one dose of BIIB033 (Opicinumab) or placebo, and did not receive MS modifying therapies in RENEW Study (NCT01721161).|||millilitres (mL)||Standard Deviation|Mean
2560900|NCT02657889|Secondary|Phase 2: Disease Control Rate (DCR)|DCR is defined as the percentage of patients who achieved a CR or PR or stable disease (SD) using RECIST (v1.1) as assessed by the Investigator.|Up to 40 weeks|The analysis was performed on all patients who received at least one dose of study medication.|||percentage of participants||90% Confidence Interval|Number
2560890|NCT02657915|Secondary|Change in Number of Gadolinium (Gd)-Enhanced Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915)|Change in disease activity from baseline with brain magnetic resonance imaging (MRI) was calculated and reported. MRI analysis included number of consensus GD-enhanced lesions as a measure of disease activity.|Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)|The PP population was defined as participants from the ITT population who completed the study, did not miss more than one dose of BIIB033 (Opicinumab) or placebo, and did not receive MS modifying therapies in RENEW Study (NCT01721161).|||lesions||Standard Deviation|Mean
2560891|NCT02657915|Secondary|Severity of CNS Demyelinating Disease as Assessed Using the Multiple Sclerosis Functional Composite (MSFC) Assessment|MSFC has 3 component- timed 25-foot walk (T25FW), 9-hole peg test (9HPT) [dominant and nondominant hands] and (3-second) paced auditory serial addition Test (PASAT). The MSFC Z-score is calculated by creating Z-scores for each component of the MSFC and averaging them to create an overall composite score. MSFC Z-score = (Z25-foot-walk + Z9HPT + ZPASAT-3)/3, where Zj refers to Z-scores of component j. A Z-score represented the number of standard deviations participant's test result was higher (Z >0) or lower (Z <0) than the average test result (Z = 0) from the reference population. Higher scores indicate better outcomes.|Day 1 (NCT02657915)|The PP population was defined as participants from the ITT population who completed the study, did not miss more than one dose of BIIB033 (Opicinumab) or placebo, and did not receive MS modifying therapies in RENEW Study (NCT01721161).|||Z-score||Standard Deviation|Mean
2560892|NCT02657915|Secondary|Severity of CNS Demyelinating Disease as Assessed Using the Symbol- Digit Modalities Test (SDMT)|SDMT is a screening test for cognitive impairment. Participants were given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best). Originate from the occipital cortex, the area of the brain involved in receiving and interpreting visual signals.|Day 1 (NCT02657915)|The PP population was defined as participants from the ITT population who completed the study, did not miss more than one dose of BIIB033 (Opicinumab) or placebo, and did not receive MS modifying therapies in RENEW Study (NCT01721161).|||score on a scale||Standard Deviation|Mean
2560893|NCT02657915|Secondary|Severity of Central Nervous System (CNS) Demyelinating Disease as Assessed Using the Expanded Disability Status Scale (EDSS)|The EDSS score is based on neurological testing and an examination of functional systems (FS), which are areas of the central nervous system which control bodily functions. These functional systems are: pyramidal (ability to walk), Cerebellar (coordination), brain stem (speech and swallowing), sensory (touch and pain), bowel and bladder functions, visual, mental and Other (includes any other neurological findings due to MS). An overall score ranging from 0 (normal) to 10 (disability) was calculated. Higher scores indicate greater disability.|Day 1 (NCT02657915)|The PP population was defined as participants from the ITT population who completed the study, did not miss more than one dose of BIIB033 (Opicinumab) or placebo, and did not receive MS modifying therapies in RENEW Study (NCT01721161).|||score on a scale||Standard Deviation|Mean
2560894|NCT02657915|Secondary|Time to Diagnosis of CDMS|The diagnosis of CDMS was made on the basis of clinical criteria and requires that a patient experience at least 2 neurologic events consistent with demyelination, separated both in time and in location in the central nervous system. Time to diagnosis of CDMS in Study NCT02657915 was the time from the diagnosis of acute optic neuritis (AON) to the date of confirmed MS. Measured in Days using the Median (50th percentile) for each arm.|RENEW Study (NCT01721161) to Day 1 (NCT02657915)|The PP population was defined as participants from the ITT population who completed the study, did not miss more than one dose of BIIB033 (Opicinumab) or placebo, and did not receive MS modifying therapies in RENEW Study (NCT01721161).|||days||Inter-Quartile Range|Median
2560895|NCT02657915|Secondary|Number of Participants That Developed Clinically Definite Multiple Sclerosis (CDMS) After Enrollment in RENEW Study (NCT01721161)|The diagnosis of clinically definite multiple sclerosis (CDMS) was made on the basis of clinical criteria and requires that a patient experience at least 2 neurologic events consistent with demyelination, separated both in time and in location in the central nervous system.|RENEW Study (NCT01721161) to Day 1 (NCT02657915)|The PP population was defined as participants from the ITT population who completed the study, did not miss more than one dose of BIIB033 (Opicinumab) or placebo, and did not receive MS modifying therapies in RENEW Study (NCT01721161).|||participants|||Number
2560896|NCT02657915|Primary|FF-VEP Latency of the Affected Eye as Compared to the Baseline of the Fellow Eye at 2 Years (+ up to 12 Months) After the Last Study Visit Assessment (Week 32) in RENEW Study (NCT01721161)|A full field visual evoked potential (FF-VEP) is an evoked potential caused by a visual stimulus, such as an alternating checkerboard pattern on a computer screen. Responses are recorded from electrodes that are placed on the back of the head and are observed as a reading on an electroencephalogram (EEG). These responses usually originate from the occipital cortex, the area of the brain involved in receiving and interpreting visual signals.|Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)|Per protocol (PP) population: defined as participants from ITT population who completed the study, did not miss more than 1 dose of BIIB033 (Opicinumab) or placebo, and did not receive MS modifying therapies in RENEW Study (NCT01721161). The statistical analysis plan specified that efficacy analyses performed in PP were considered primary analyses.|||milliseconds (msec)||Standard Deviation|Mean
2560897|NCT02657889|Secondary|Phase 1 and Phase 2: To Evaluate the Pharmacokinetics (PK) of Niraparib and Associated Major Metabolite M1 During Combination Treatment.|Area Under the Curve (AUC), Minimum Concentration (Cmin), Maximum Concentration (Cmax), Clearance After Oral Administration (CL/F), Volume of Distribution After Oral Administration (Vz/F), AUC at Steady State (AUCss), Cmin at Steady State (Cmin,ss), Cmax at Steady State (Cmax,ss).|Approximately 9 months|||||||
2560898|NCT02657889|Secondary|Phase 2: Overall Survival (OS)|Patients were followed off treatment every 90 days for survival status. Overall survival is defined as the time from first dose to the date of death by any cause. No maximum timeframe was specified in the protocol.|From date of first dose to the date of death by any cause.|||||||
2560899|NCT02657889|Secondary|Phase 2: Progression Free Survival (PFS)|From date of first dose to the earlier date of assessment of progression or death by any cause in the absence of progression. No maximum timeframe was specified in the protocol.|From date of first dose to the earlier date of assessment of progression of death by any cause in the absence of progression.|||||||
2560938|NCT02656836|Secondary|Proportion of Patients With an Adverse Event|Any adverse event or complication associated with the use of the device. Expected side effects will be corneal erosion, and ocular irritation.|One month|||||||
2560901|NCT02657889|Secondary|Phase 2: Duration of Response (DOR)|From first documentation of response (CR or PR) using RECIST (v1.1) as assessed by the investigator until time of first documented progression or death by any cause. No maximum timeframe was specified in the protocol.|From first documentation of response (CR or PR) using RECIST (v1.1) as assessed by the Investigator until time of first documented progression.|||||||
2560902|NCT02657889|Secondary|Phase 2: Overall Response Rate (ORR) as Measured by Immune-related RECIST (irRECIST)|ORR by irRECIST is defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR) using immune-related RECIST criteria.|Radiographic evaluations were conducted every 9 weeks while on study treatment (every 12 weeks after 1 year of scans) independent of cycle delays and/or dose interruptions, and/or at any time when progression of disease is suspected.|Data were not collected.||||||
2560903|NCT02657889|Secondary|To Evaluate the Safety and Tolerability of Combination Treatment With Niraparib and Pembrolizumab Using Common Terminology Criteria for Adverse Events (CTCAE, v4.03)|Percentage of patients with at least 1 Treatment-Emergent Adverse Event. Refer to the adverse event tables for specific details.|AEs were collected up to 90 days following the last dose of study treatment, where the median duration of treatment was 3 months.|The analysis was performed on all patients who received at least one dose of study medication.|||Participants|||Count of Participants
2560904|NCT02657889|Primary|Phase 2: Objective Response Rate (ORR)|ORR is defined as the percentage of patients who achieved a best overall response of Complete Response (CR) or Partial Response (PR), per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions as assessed by the Investigator: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|Up to 40 weeks|The analysis was performed on all patients who received at least one dose of study medication.|||percentage of participants||90% Confidence Interval|Number
2560905|NCT02657889|Primary|Phase 1: Number of Subjects Reporting Dose-Limiting Toxicities (DLTs)|"DLTs are defined as:~Any treatment-related Grade ≥ 3 non-hematologic clinical (non-laboratory) AE~Any treatment-related Grade 3 or Grade 4 non-hematologic lab abnormality if:~Medical intervention is required to treat the patient, or~The abnormality leads to hospitalization, or~The abnormality persists for ≥ 7 days.~Any treatment-related hematologic toxicity specifically defined as:~Thrombocytopenia Grade 4 for ≥ 7 days, or Grade 3 or 4 associated with bleeding or requiring platelet transfusion;~Neutropenia Grade 4 for ≥ 7 days, or Grade 3 or 4 associated with infection or febrile neutropenia;~Anemia Grade 4, or Grade 3 or 4 requiring blood transfusion.~Any treatment-related AE leading to niraparib dose interruption per the following criteria:~A dose interruption for a non-DLT lab abnormality lasting ≥ 14 days.~A dose in interruption per dose modification rules for nonhematologic AE leading to < 80% of an intended dose being administered."|During Cycle 1, ie, during the first 21 days of treatment|The assessment of DLTs in Phase 1 included only those patients completing the first cycle of therapy, unless the patient discontinued study drug due to a DLT.|||Participants|||Count of Participants
2560906|NCT02657629|Primary|Weight Gain in Grams Per Day||Daily until hospital discharge (up to maximum of 3 months of age)||||grams/day||Standard Deviation|Mean
2560907|NCT02657564|Secondary|Number of Participants With Acute Electrolyte Disturbance (Including Serum Caclium, Phosphate, Sodium, Potassium, Chloride, and Magnesium).|The screening visit (visit 1) induced a blood specimen for serum chemistry analysis. Immediately before the colonoscopy, study staff collected blood specimens for chemistry analysis (visit 2). The patients returned within 28 days after the colonoscopy for a final renal safety evaluation (visit 3). Patients with electrolyte abnormalities during visit 2 or visit 3 were followed every 2-4 weeks until serum electrolyte values returned to normal.|The durations between visits 1-2 and visits 2-3 were within 28 days, respectively. Patients with electrolyte abnormalities during visit 2 or visit 3 were followed every 2-4 weeks until serum electrolyte values returned to normal.||||Participants|||Count of Participants
2560908|NCT02657564|Primary|Number of Participants With Acute Renal Injury Which Included Acute Renal Dysfunction and Acute Kidney Injury|The screening visit (visit 1) induced a blood specimen for serum chemistry analysis. Immediately before the colonoscopy, study staff collected blood specimens for chemistry analysis (visit 2). The patients returned within 28 days after the colonoscopy for a final renal test (visit 3). Patients with a ≥30% increase above baseline creatinine levels during visit 2 or 3 were followed every 2-4 weeks until a peak level was detected (visit 4 and beyond).The serum creatinine level on visit 1 was recorded as the baseline renal function. The presence of renal injuries was determined by the highest serum creatinine level noted during the study period and included acute renal dysfunction, defined as a 30-49% increase above the baseline creatinine level, and acute kidney injury, defined as a ≥50% increase above the baseline serum creatinine. Number of participants with acute renal injury which included acute renal dysfunction and acute kidney injury will be recorded.|The durations between visits 1-2 and visits 2-3 were within 28 days, respectively. Patients with a ≥30% increase above the baseline serum creatinine levels during visit 2 or 3 were followed every 2-4 weeks until a peak level of creatinine was detected.||||participants|||Number
2560909|NCT02657538|Secondary|Lesion Activity|active lesions: 1; inactive lesions: 0|One year|The data were not collected and the Outcome will never be analyzed because of the study population. The participants are all low risk in the analysis of caries, with low amount of gingivitis and good oral hygiene what means that no progression/ change in caries activity will be detectable in any patient. So it doesn't make sense to analyze it.||||||
2560910|NCT02657538|Primary|Caries Extension According to Diagnocam Codes 0-4 (Intra- and Interrater-Reliability, Sensitivity and Specificity)|"The geometrical shape of caries lesions is displayed with the near infrared transillumination method. These shapes are classified as: code 0: no lesion visible; code 1: first visible signs in enamel; code 2: established, clear visible signs in enamel; code 3: clear visible in enamel and punctual contact with dentine; code 4: clearly visible and broad contact with dentine~Intra- and Interrater-Reliability: Reliability indicates the overall consistency of a measurement. To have a high reliability means in this case, that the diagnostic-tool produces similar results under consistent conditions. The interrater-Reability assesses the degree of agreement between two different raters in their diagnostics on a specific test while the intrarater-Reliability assesses the degree of agreement of a single rater who did a diagnostic-test twice under the same testing conditions.~Sensitivity and Specificity: Statistics are not done yet but will be updated when we calculated them"|One year||||weighted Kappa|Participants|95% Confidence Interval|Mean
2560911|NCT02657408|Secondary|Differential Cell Count of Lymphocyte in BAL Fluid 24 h After Segmental LPS Challenge.|"Differential cell count of lymphocyte in BAL fluid 24 h after segmental LPS challenge.~The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method."|Day 29|PDS|||Percentage of lymphocyte||Standard Error|Geometric Mean
2560912|NCT02657408|Secondary|Total Cell Count of Lymphocyte in BAL After 24 Hours of the Segmental LPS Challenge|"Total cell count of lymphocyte after 24 hours of the segmental LPS challenge.~The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method."|Day 29|PDS|||cells*10^3/mL||Standard Error|Geometric Mean
2560913|NCT02657408|Secondary|Differential Cell Count of Macrophage+Monocyte in BAL Fluid 24 h After Segmental LPS Challenge.|"Differential cell count of macrophage+monocyte in BAL fluid 24 h after segmental LPS challenge.~The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.~Cytospin microscopy method cannot clearly differentiate between macrophages and monocytes, the total and differential cell count of macrophages and monocytes are presented together."|Day 29|PDS|||Percentage of macrophage+monocyte||Standard Error|Geometric Mean
2560914|NCT02657408|Secondary|Total Cell Count of Macrophage+Monocyte in BAL Fluid After 24 Hours of the Segmental LPS Challenge|"Total cell count of macrophage+monocyte BAL fluid after 24 hours of the segmental LPS challenge.~The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.~Cytospin microscopy method cannot clearly differentiate between macrophages and monocytes, the total and differential cell count of macrophages and monocytes are presented together."|Day 29|PDS|||cells*10^3/mL||Standard Error|Geometric Mean
2560915|NCT02657408|Secondary|Differential Cell Count of Monocyte in BAL Fluid 24 h After Segmental LPS Challenge.|"Differential cell count of monocyte (determined by flow cytometry) in BAL fluid 24 h after segmental LPS challenge.~The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method.~Monocyte cell count is the only cell count which was assessed by means of flow cytometry."|Day 29|PDS|||Percentage of monocyte||Standard Error|Geometric Mean
2560916|NCT02657408|Secondary|Total Cell Count of Monocyte in BAL Fluid After 24 Hours of the Segmental LPS Challenge|"Total cell count of monocyte in BAL fluid after 24 hours of the segmental LPS challenge.~The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method. Monocyte cell count is the only cell count which was assessed by means of flow cytometry."|Day 29|PDS|||cells*10^3/mL||Standard Error|Geometric Mean
2560917|NCT02657408|Secondary|Differential Cell Count of Eosinophil in BAL Fluid 24 h After Segmental LPS Challenge.|"Differential cell count of eosinophil in BAL fluid 24 h after segmental LPS challenge.~The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method."|Day 29|PDS|||Percentage of eosinophil||Standard Error|Geometric Mean
2560918|NCT02657408|Secondary|Total Cell Count of Eosinophil in BAL Fluid After 24 Hours of the Segmental LPS Challenge|"Total cell count of eosinophil in BAL fluid after 24 hours of the segmental LPS challenge.~The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method."|Day 29|PDS|||cells*10^3/mL||Standard Error|Geometric Mean
2560919|NCT02657408|Secondary|Differential Cell Count of Neutrophils in BAL Fluid 24 h After Segmental LPS Challenge.|"Differential cell count of neutrophils in BAL fluid 24 h after segmental LPS challenge.~The adjusted geometric means (gMeans) are obtained by exponentiating the LS means obtained by fitting an ANOVA model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method."|Day 29|PDS|||Percentage of neutrophils||Standard Error|Geometric Mean
2560920|NCT02657408|Primary|Total Cell Count of Neutrophils in Bronchoalveolar Lavage (BAL) Fluid After 24 Hours of the Segmental Lipopolysaccharide (LPS) Challenge|"Total cell count of neutrophils in Bronchoalveolar Lavage (BAL) fluid after 24 hours of the segmental Lipopolysaccharide (LPS) challenge.~The adjusted geometric means (gMeans) are obtained by exponentiating the Least Square (LS) means obtained by fitting an Analysis of variance (ANOVA) model on the natural log transformed endpoint values, adjusted for treatment effect. Standard errors are derived using the delta method."|Day 29|Pharmacodynamic set (PDS): The pharmacodynamic set included all treated subjects who had evaluable cell counts for the primary or secondary endpoints 24 h after segmental LPS challenge.|||cells*10^3/mililiter (mL)||Standard Error|Geometric Mean
2560921|NCT02657369|Secondary|Median OS|OS was defined as the time from the date of beginning of lenvatinib administration until date of death from any cause. Median OS was estimated using the Kaplan-Meier method. Participants with last known alive date as study terminated by sponsor were censored.|From the date of beginning of lenvatinib administration up to date of death from any cause (up to Month 27)|The full analysis set included all participants who received at least one dose of lenvatinib.|||months||95% Confidence Interval|Median
2560922|NCT02657369|Secondary|Median PFS|PFS was defined as the time from the date of beginning of lenvatinib administration to the date of first documentation of confirmed disease progression or death, whichever occurs first. Median PFS was estimated using the Kaplan-Meier method. Participants who were off study due to lost to follow up, withdrew consent, or study terminated by sponsor, had new anti-cancer treatment, had no baseline/post-baseline tumor assessments, or missed 2 or more visits prior to event were censored.|From the date of beginning of lenvatinib administration to the date of first documentation of confirmed disease progression or death, whichever occurred first (up to Month 27)|The full analysis set included all participants who received at least one dose of lenvatinib.|||months||95% Confidence Interval|Median
2560923|NCT02657369|Secondary|Overall Survival (OS) Rate|Six-month OS rate was defined as the percentage of participants in the analysis population who are alive at 6 months. OS was defined as the time from the date of beginning of lenvatinib administration until date of death from any cause. The Kaplan-Meier estimated rate method was used to estimate six-month OS, along with the corresponding 95% CI. Participants with last known alive date as study terminated by sponsor were censored.|From the date of beginning of lenvatinib administration up to date of death from any cause (up to Month 6)|The full analysis set included all participants who received at least one dose of lenvatinib.|||percentage of participants||95% Confidence Interval|Number
2560924|NCT02657369|Secondary|Progression-free Survival (PFS) Rate|Twelve-week PFS rate was the percentage of participants in the analysis population who remain alive and progression-free at 12 weeks. PFS was defined as the time from the date of beginning of lenvatinib administration to the date of first documentation of confirmed disease progression or death, whichever occurred first. The Kaplan-Meier estimated rate method was used to estimate 12-week PFS, along with the corresponding 95% confidence interval (CI). Participants who were off study due to lost to follow up, withdrew consent, or study terminated by sponsor, had new anti-cancer treatment, had no baseline/post-baseline tumor assessments, or missed 2 or more visits prior to event were censored.|From the date of beginning of lenvatinib administration up to the date of first documentation of confirmed disease progression or death, whichever occurred first (up to Week 12)|The full analysis set included all participants who received at least one dose of lenvatinib.|||percentage of participants||95% Confidence Interval|Number
2560925|NCT02657369|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator review using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for target lesions. CR was defined as disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameters of target lesions, taking as reference the Baseline sum diameters. Confirmation of CR or PR was performed at least 28 days following the initial achievement of the response.|From the date of beginning of lenvatinib administration to the date of first documentation of disease progression or death, whichever occurred first (up to Month 27)|The evaluable analysis set included all participants with histological diagnosis of ATC that was confirmed by central pathology review and who received at least one dose of lenvatinib.|||percentage of participants||95% Confidence Interval|Number
2560926|NCT02657252|Secondary|Number of Participants With Deep Venous Thrombosis (DVT)|Observe after one week of treatment occurred if clinical signs and symptoms of deep vein thrombosis (DVT) and perform duplex ultrasound for confirmation. Compare the results between the two groups to establish a security policy.|1 week||||Participants|||Count of Participants
2560927|NCT02657252|Secondary|Skin Hyperpigmentation|Observed after two months of treatment the occurrence of hyperpigmentation stains in the treated areas. Measuring in centimeters those stains and compare the two treatments together.|2 months||||percentage of hyperpigmentation||95% Confidence Interval|Median
2560928|NCT02657252|Primary|Change From Baseline in Extent of Telangiectasias|Efficiency in promoting the disappearance of the treated telangiectasias, making the comparison between the initial measurements in centimeters and after two months, then comparing the treatment between the two treatments|2 months|Only one lower limb submited to the treatment.|||percent of change negative values||Standard Deviation|Mean
2560929|NCT02657226|Secondary|Hospital Length of Stay|Hospital length of Stay was measured among urine output group and reported as median (Inter-Quartile Range).|30 days||||days||Inter-Quartile Range|Median
2560930|NCT02657226|Secondary|Length of Stay in ICU|Patients with and without AKI were compared among urine output group for duration of stay in ICU and hospital.|30 days|Median (Inter-Quartile Range) were reported.|||days||Inter-Quartile Range|Median
2560931|NCT02657226|Secondary|Mortality|Hazard Ratios were measured to detect the risk of mortality at 30 days from ICU admission.|30 days|Intensive monitoring by urine output and serum creatinine among AKI population is reported.|||Hazard Ratio||95% Confidence Interval|Number
2560932|NCT02657226|Primary|Detection of Acute Kidney Injury (AKI)|We classified AKI according to the maximum Kidney Disease Improving Global Outcomes criteria met during the 7 days after ICU admission using both SC and UO criteria. Admission creatinine levels were the first creatinine value recorded for the index hospital admission. Reference creatinine level was taken as the baseline creatinine level when available; otherwise, it was the lowest between admission creatinine level or creatinine level recorded in the 24 hours following ICU admission estimated using MDRD equation. For all analyses, we used moderate to severe AKI defined as stage 2-3. For UO criteria, at least every 6 hours data was required to stage AKI regardless of whether the patient had intensive or nonintensive UO monitoring overall.Odds ratio were measured between two groups.Odds ratios were determined using multivariable models for intensive vs non-intensive UO and between intensive vs non-intensive creatinine monitoring groups.|7 days from ICU admission|All patients receiving UO or SC monitoring|||Odds Ratio||95% Confidence Interval|Number
2560933|NCT02657031|Secondary|The Number of Patients Experiencing Restlessness|Yes/No|0-60 minutes||||participants|||Number
2560934|NCT02657031|Secondary|The Number of Participants Experiencing Vomiting|Yes/No|0-60 minutes||||participants|||Number
2560935|NCT02657031|Secondary|Nausea|Reduction in 100 mm Visual Analog Scale (VAS) Score. The maximum possible change in VAS score is 100 mm, representing the complete relief of maximum nausea. A change of 0 mm corresponds to no change in nausea level, and a negative value indicates worsening of the nausea after the medication.|0-60 minutes||||mm||Standard Deviation|Mean
2560936|NCT02657031|Secondary|Anxiety|Reduction in 100 mm Visual Analog Scale (VAS) Score. The maximum possible change in VAS score is 100 mm, representing the complete relief of maximum anxiety. A change of 0 mm corresponds to no change in anxiety level, and a negative value indicates worsening of the anxiety after the medication.|0-60 minutes||||mm||Standard Deviation|Mean
2560937|NCT02657031|Primary|Headache Following Intervention|Reduction in 100 mm Visual Analog Scale (VAS) Score. Positive values represent a reduction in headache severity. The maximum possible change in VAS score is 100 mm, representing the complete relief of a maximally severe headache. A change of 0 mm corresponds to no change in headache severity, and a negative value indicates worsening of the headache after the medication.|0-60 minutes||||mm||95% Confidence Interval|Mean
2560940|NCT02656836|Primary|Intraocular Pressure|Intraocular pressure in mmHg units, obtained by tonometers. The investigators will determine agreement of intraocular pressure (IOP) measured using the home tonometer (patient) compared with IOP measured in the clinic.|Two weeks||||mmHg||Standard Deviation|Mean
2560941|NCT02656745|Secondary|Efficacy - Smoking Cessation [7-day Abstinence & 30 Day Abstinence]|To assess whether continued user engagement is correlated with smoking cessation and behaviors.|8 week core study|ITT sample included all subjects who consented to participation, fulfilled study entry criteria, completed the Introductory Questionnaire to receive the access code, and downloaded Clickotine®, and create a user profile. Completer sample included all ITT participants that also completed the outcome survey.|||Participants|||Count of Participants
2560942|NCT02656745|Secondary|Number of Participants With Treatment-related Adverse Events|To evaluate the tolerability and safety of the application|8 week core study|416 participants ultimately downloaded the app and constituted the ITT population.|||Participants|||Number
2560943|NCT02656745|Primary|Number of Participants Who Remain Active Users of the Program|The primary objective is to assess the proportion of the Intent to Treat population who remain active users of the program at the end of the 8 week primary study period. Active use is defined as the manipulation of at least one component of the application per week.|8 week core study|416 participants ultimately downloaded the app and constituted the ITT population.|||Participants|||Count of Participants
2560944|NCT02656693|Secondary|Changes in Percentage of Patients Reporting Excellent/Very Good Health Status Assessed by Using a 5-point Scale Questionnaire From the 36-Item Short Form Health Survey(SF-36)|"Health status will be assessed using 5-point scale response to a single question from the SF-36, In general, would you say that your health is...(1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor). A higher score indicates a worse outcome (5= poor health status)."|12 months after the initial primary care visit||||change in percentage of patients||95% Confidence Interval|Number
2560945|NCT02656693|Secondary|Changes in Self-reported Physical Activity|changes in self-reported physical activity minutes per week|12 months after the initial primary care visit||||minutes/day||95% Confidence Interval|Mean
2560946|NCT02656693|Secondary|Changes in Diet, Specifically Whole Grains, as Measured by the PrimeScreen Questionnaire|changes in diet, specifically whole grains as measured by the PrimeScreen questionnaire, a brief dietary screening tool.|12 months after the initial primary care visit||||servings/day||95% Confidence Interval|Mean
2560947|NCT02656693|Secondary|Changes in Diet, Specifically Fruits/Vegetables, as Measured by the PrimeScreen Questionnaire|changes in diet, specifically fruits/vegetables as measured by the PrimeScreen questionnaire, a brief dietary screening tool.|12 months after the initial primary care visit||||servings/day||95% Confidence Interval|Mean
2560948|NCT02656693|Secondary|Changes in Self-efficacy Around Weight Loss at 12 Months|"Changes in self-efficacy around weight loss at 12 months Self-efficacy will be assessed by asking patients to rate their confidence in their ability to lose weight on a scale from 1 (not at all confident) to 10 (very confident). A rank of 1-7 reflects low self-efficacy, while 8-10 reflects high self-efficacy based on Bandura's theory of self-efficacy."|12 months after initial primary care visit||||score on a scale||95% Confidence Interval|Mean
2560949|NCT02656693|Secondary|Changes in Weight-related Quality of Life Assessed by the Impact of Weight on Quality of Life (IWQOL)-Lite Questionnaire|"Weight-related quality of life will be assessed using the Impact of Weight of Quality of Life (IWQOL)-Lite questionnare. The IWQOL-Lite is a brief, 31-item self-report measure that consists of scores on five scales (physical function, self-esteem, sexual life, public distress, and work) and a total score (sum of scale scores). Participants are asked to rate items with respect to the past week, with responses from never true to always true. Total scores range from 0 (worst possible quality of life) to 100 (best possible quality of life)."|12 months after the initial primary care visit||||score on a scale||95% Confidence Interval|Mean
2560950|NCT02656693|Secondary|Changes in HbA1c Levels|changes in Hemoglobin (HbA1c) levels from enrollment to 12 months|12 months after the initial primary care visit||||% of HbA1c||95% Confidence Interval|Mean
2560951|NCT02656693|Secondary|Changes in Triglycerides|changes in triglycerides from enrollment to 12 months|12 months after the initial primary care visit||||mg/dL||95% Confidence Interval|Mean
2560952|NCT02656693|Secondary|Changes in Cholesterol|changes in total cholesterol from Enrollment to 12 Months|12 months after the initial primary care visit||||mg/dL||95% Confidence Interval|Mean
2560953|NCT02656693|Secondary|Changes in Diastolic Blood Pressure|changes in diastolic blood pressure (BP) from enrollment to 12 months|12 months after the initial primary care visit||||mmHg||95% Confidence Interval|Mean
2560954|NCT02656693|Secondary|Changes in Systolic Blood Pressure|changes in systolic blood pressure (BP) from enrollment to 12 months|12 months after the initial primary care visit||||mmHg||95% Confidence Interval|Mean
2560955|NCT02656693|Primary|Change in Body Weight at 12 Months|change in body weight from enrollment to 12 months|12 months after the initial primary care visit||||lbs||95% Confidence Interval|Mean
2560956|NCT02656485|Secondary|Efficacy|Absolute Change from Baseline in Total Number of Lesions|Baseline and 4 weeks|All efficacy and safety data were analyzed using the ITT/Safety population.|||Lesions||Standard Deviation|Mean
2560957|NCT02656485|Primary|Safety (Number of Participants With Treatment Related Adverse Events)|Number of participants with treatment related adverse events as assessed by physical examination, vital signs, clinical laboratory values, local skin responses|4 weeks|The safety analysis set included all subjects in the ITT/Safety population.|||Participants|||Count of Participants
2560958|NCT02656420|Secondary|Modulation of Air Pollutant Excretion in Sequential Overnight 12-Hour Urine Samples|"Benzene-mercapturic acid (SPMA) excretion was measured in the sequential overnight 12-hour urine samples collected across the 10-day study period. Data from each individual were summed and averaged to provide a single per 12-hours value for each participant."|10 days|Due to irreversible failure of the mass spectrometer used in this analysis, not all urine samples were evaluated for SPMA levels. Only individuals for whom all 10 samples were collected and analyzed are included in this summary (132/169).|||nmol SPMA excreted/ 12 hours||Inter-Quartile Range|Geometric Mean
2560993|NCT02656173|Secondary|Change From Baseline to EoT in Maximum Urine Flow Rate (Qmax)|Urine flow rate was volume voided per micturition (voided volume) divided by time for the micturition (flow time).|Baseline and EoT (up to 12 weeks)|SAF. EoT value was defined as last post-baseline assessment during the double-blind study period for which the safety data are available.|||mL||Standard Deviation|Mean
2560959|NCT02656420|Primary|Sulforaphane Bioavailability Measured in Sequential 12-Hour Urine Samples|"Urinary excretion of broccoli-derived sulforaphane metabolites: sulforaphane-mercapturic acid. The metabolites were measured all 20 of the sequential 12-hour urine collections from each participant over the 10-day intervention period. Data from each individual were summed to provide a single per 24-hours value for each participant."|10 days|Placebo arm samples were not analyzed f because no sulforaphane was administered to this group. Historically, background levels from dietary sources in this population are very low compared to active intervention levels. In addition, one participant in the High Dose Broccoli Sprout arm did not complete the full protocol and was not included.|||micromoles/24 hours||Inter-Quartile Range|Geometric Mean
2560960|NCT02656329|Secondary|Percentage of Participants With Events of Complications of Device|Composite of the percentage of participants with events of hospitalization or death related to major complications of device implantation (i.e., need for thoracotomy, pericardiocentesis, or vascular surgery), complications of long-term device therapy (i.e., infection not leading to hospitalization, lead and/or generator removal/replacement, inappropriate shocks, explanation), and combined as 'complications of device'.|From randomization until the end of the follow-up period (median 304 days)|Analysis was performed on FAS population.|||percentage of participants|||Number
2560961|NCT02656329|Secondary|Percentage of Participants With Implantable Cardioverter Defibrillator (ICD) Implantation|Percentage of participants with ICD implantation were reported.|From randomization until the end of the follow-up period (median 304 days)|Analysis was performed on FAS population.|||percentage of participants|||Number
2560962|NCT02656329|Secondary|Percentage of Participants With Syncope|Percentage of participants with Syncope were reported. Participants who were alive at time of DBL were censored at the last known-alive date by date of DBL.|From randomization until the end of the follow-up period (median 304 days)|Analysis was performed on FAS population.|||percentage of participants|||Number
2560963|NCT02656329|Secondary|Percentage of Participants With Events (Composite of the Occurrence of Resuscitated Life-Threatening Ventricular Tachycardia, Unstable Ventricular Tachyarrhythmias, Sudden Cardiac Death [SCD] and Resuscitated Cardiac Arrest)|Percentage of participants with composite events i.e occurrence of resuscitated life-threatening ventricular tachycardia, unstable ventricular tachy-arrhythmias, SCD and resuscitated cardiac arrest were reported. Participants who were alive at time of database lock (DBL) were censored at the last known-alive date.|From randomization until the end of the follow-up period (median 304 days)|Analysis was performed on FAS population.|||percentage of participants|||Number
2560964|NCT02656329|Secondary|Percentage of Participants With All-Cause Hospitalization|Percentage of participants with all-cause hospitalization were reported.|From randomization until the end of the follow-up period (median 304 days)|Analysis was performed on FAS population.|||percentage of participants|||Number
2560965|NCT02656329|Secondary|Percentage of Participants With Hospitalization for Cardiovascular Cause|Percentage of participants who were hospitalized for cardiovascular cause were reported.|From randomization until the end of the follow-up period (median 304 days)|Analysis was performed on FAS population.|||percentage of participants|||Number
2560966|NCT02656329|Secondary|Percentage of Participants With Cardiac Death|Cardiac death composed of sudden cardiac death, death due to cardiac arrhythmia, death due to heart failure, and death due to other cardiovascular causes.|From randomization until the end of the follow-up period (median 304 days)|Analysis was performed on FAS population.|||percentage of participants|||Number
2560967|NCT02656329|Secondary|Percentage of Participants With Events of Complications of Device: H/M >=1.6 in Full Analysis Set|Composite of the percentage of participants with events of hospitalization or death related to major complications of device implantation (i.e., need for thoracotomy, pericardiocentesis, or vascular surgery), complications of long-term device therapy (i.e., infection not leading to hospitalization, lead and/or generator removal/replacement, inappropriate shocks, explanation), and combined as 'complications of device' for participants with H/M >=1.6. Participants who were alive at time of database lock (DBL) were censored at the last known-alive date.|From randomization until the end of the follow-up period (median 304 days)|Analysis was performed on FAS population. Here, overall number of participants analyzed = participants with H/M >=1.6.|||percentage of participants|||Number
2560968|NCT02656329|Primary|All-cause Mortality|All-cause mortality included all reported deaths of participants during the study due to any cause. Percentage of participants who died due to any cause were reported.|From randomization until the end of the follow-up period (median 304 days)|Analysis was performed on full analysis set (FAS) that was defined as participants included in the safety analysis set who were randomised to the AdreView™ group or the SoC group.|||percentage of participants|||Number
2560969|NCT02656290|Other Pre-specified|Urine Urobilinogen (if Necessary for Subjects 12 Years and Under)|Laboratory Analysis of urobilinogen in urine measures the amount of urobilinogen in a urine sample. Urobilinogen is formed from the reduction of bilirubin. Bilirubin is a yellowish substance found in your liver that helps break down red blood cells.|Baseline, 6 months, and annually for up to 5 years|||||||
2560970|NCT02656290|Other Pre-specified|Subject's Average International Normalized Ratio(INR)/Partial Thromboplastin Time(PTT)|"The INR is a calculation based on results of a prothrombin time (PT). The PT is a blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot.~PTT is a blood test that looks at how long it takes for the blood to clot."|Baseline, 6 months, and annually for up to 5 years|||||||
2560971|NCT02656290|Other Pre-specified|Subject's Average Plasma Free Hemoglobin or Haptoglobin or Serum LDH|"Laboratory Analysis on blood drawn from subjects. Plasma free hemoglobin test measures the level of free hemoglobin in the liquid part of the blood (the serum).~Haptoglobin is a protein produced by the liver. The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues."|Baseline, 6 months, and annually for up to 5 years|||||||
2560972|NCT02656290|Other Pre-specified|Subject's Average Platelet Count|Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.|Baseline, 6 months, and annually for up to 5 years|||||||
2560973|NCT02656290|Other Pre-specified|Subject's Average Hematocrit Percentage|Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component(plasma) in the blood.|Baseline, 6 months, and annually for up to 5 years|||||||
2560974|NCT02656290|Other Pre-specified|Subject's Average Hemoglobin Count|Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.|Baseline, 30 days, 6 months, and annually for up to 5 years|||||||
2560977|NCT02656290|Secondary|Cross-tabulation of Modified Ross Heart Failure Classification for Subjects 12 Years and Under|"The Modified Ross Heart Failure classification system relates symptoms to everyday activities and the adolescent patient's quality of life.~Class I. No limitations or symptoms~Class II. Infants: Mild tachypnea or diaphoresis with feeding Older children: Mild to moderate dyspnea on exertion~Class III. Infants: Growth failure and marked tachypnea or diaphoresis with feeding Older children: Marked dyspnea on exertion~Class IV. Symptoms at rest such as tachypnea, retractions, grunting, or diaphoresis"|Baseline and 1 Year|||||||
2560978|NCT02656290|Secondary|Modified Ross Heart Failure Classification for Subjects 12 Years and Under|"The Modified Ross Heart Failure classification system relates symptoms to everyday activities and the adolescent patient's quality of life.~Class I. No limitations or symptoms~Class II. Infants: Mild tachypnea or diaphoresis with feeding Older children: Mild to moderate dyspnea on exertion~Class III. Infants: Growth failure and marked tachypnea or diaphoresis with feeding Older children: Marked dyspnea on exertion~Class IV. Symptoms at rest such as tachypnea, retractions, grunting, or diaphoresis"|Baseline, 30 days, 6 months, and annually for up to 5 years|||||||
2560979|NCT02656290|Secondary|Cross-tabulation of New York Heart Association (NYHA) Functional Class for Subjects Older Than 12 Years|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).~Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).~Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.~Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases."|Baseline and 1 Year|||||||
2560980|NCT02656290|Secondary|Subject's New York Heart Association (NYHA) Functional Class for Subjects Older Than 12 Years|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).~Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).~Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.~Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases."|Baseline, 30 days, 6 months, and annually thereafter for up to 5 years|||||||
2560981|NCT02656290|Secondary|Transvalvular VTI|Tricuspid valvular regurgitation velocity time interval (VTI) is defined as the measurement in centimeters of the blood flowing backwards through the tricuspid valve, averaged over time.|Baseline, 6 months, and annually thereafter for up to 5 years|||||||
2560982|NCT02656290|Secondary|Doppler Velocity Index (DVI)|The Doppler Velocity Index (DVI) is a calculation of the ratio of the subvalvular velocity obtained by pulse wave Doppler and the maximum velocity obtained by continuous wave Doppler across the prosthetic valve.|Baseline, 6 months, and annually thereafter for up to 5 years|||||||
2560983|NCT02656290|Secondary|Peak Velocity|Peak velocity is defined as the maximum speed in meters per second that the blood is flowing through the pulmonic heart valve in a given direction.|Baseline, 6 months, and annually thereafter for up to 5 years|||||||
2560984|NCT02656290|Secondary|TR Gradient|Tricuspid regurgitation (TR) gradient (peak systolic) is defined as the maximum value measured of blood flowing back through the tricuspid valve during systole as measured in millimeters of mercury.|Baseline, 6 months, and annually thereafter for up to 5 years|||||||
2560985|NCT02656290|Secondary|Subject's Amount of Valvular Regurgitation|Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.|Baseline, 6 months, and annually thereafter for up to 5 years|||||||
2560986|NCT02656290|Secondary|Subject's Average Peak Gradients|Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.|Baseline, 6 months, and annually thereafter for up to 5 years|||||||
2560987|NCT02656290|Secondary|Subject's Average Mean Gradient|Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.|Baseline, 6 months, and annually thereafter for up to 5 years|||||||
2560988|NCT02656290|Secondary|Late Adverse Events|1) All cause mortality, 2) All/Major paravalvular leak, 3) All/Major transvalvular leak, 4) Endocarditis, 5) Explant, 6) Thromboembolism, 7) Valve-related reoperation, 8) Structural valve deterioration, 9) Non-structural valve deterioration, 10) Trial valve-related mortality, 11) Valve thrombosis, 12) All/Major valve-related bleeding, 13) Hemolysis|6 months, and annually for up to 5 years|||||||
2560989|NCT02656290|Secondary|Early Adverse Events|1) All cause mortality, 2) All/Major paravalvular leak, 3) All/Major transvalvular leak, 4) Endocarditis, 5) Explant, 6) Thromboembolism, 7) Valve-related reoperation, 8) Structural valve deterioration, 9) Non-structural valve deterioration, 10) Trial valve-related mortality, 11) Valve thrombosis, 12) All/Major valve-related bleeding, 13) Hemolysis|30 days|||||||
2560990|NCT02656290|Primary|Percent of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 1 Year Post-implant.|Subject's freedom from device or procedure related death and/or reoperation at 1 year post-implant. Time to events were estimated by Kaplan-Meier method.|1 year post-implant|The outcome is reported for subjects who received the Edwards Pericardial Aortic Bioprosthesis Model 11000A device where data is available.|||percentage of subjects|||Number
2560991|NCT02656199|Secondary|Re-intubation|Reinstitution of mechanical ventilation within 48 hours of extubation PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available.|48 hours from removal of ventilatory support|||||||
2560992|NCT02656199|Primary|Extubation Success|"Discontinuation from mechanical ventilation in 48 hours from ultrasound~PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available."|48 hours|PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available.||||||
2560994|NCT02656173|Secondary|Change From Baseline to EoT in Postvoid Residual (PVR) Volume|PVR was measured by ultrasonography.|Baseline and EoT (up to 12 weeks)|SAF. EoT value was defined as last post-baseline assessment during the double-blind study period for which the safety data are available.|||mL||Standard Deviation|Mean
2560995|NCT02656173|Secondary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) with onset during the double-blind treatment period or an AE with onset during the screening period with worsening severity during the double-blind treatment period. The investigator assessed the severity of AEs as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. Serious TEAE was an AE considered serious.|From first dose of study drug up to Week 12|Safety Analysis Set (SAF) consisted of all participants who received at least 1 dose of double-blind study drug.|||Participants|||Count of Participants
2560996|NCT02656173|Secondary|Change From Baseline to EoT in Total Health-Related QoL (HRQoL) Scores as Assessed by the OAB-q|"The OAB-q was a 33-item questionnaire, which consisted of an 8-item symptom bother scale and 25 health-related QoL items that form 4 subscales (coping, concern, sleep, and social interaction) and a total health-related QoL score.~Total HRQL score was derived as sum of HRQL subscale scores (range: 25-150). Higher total HRQL score is indicative of better HRQL."|Baseline and EoT (up to 12 weeks)|FAS. EoT value was defined as last post-baseline assessment during the double-blind study period for which the efficacy data are available.|||units on a scale||Standard Deviation|Mean
2560997|NCT02656173|Secondary|Change From Baseline to EoT in Symptom Bother as Assessed by the Overactive Bladder Questionnaire (OAB-q)|"The OAB-q was a 33-item questionnaire, which consisted of an 8-item symptom bother scale and 25 health-related QoL items that form 4 subscales (coping, concern, sleep, and social interaction) and a total health-related QoL score.~Symptom Bother was derived as sum of scores for questions 1-8 (range: 0-100). Higher Symptom Bother is indicative of greater symptom bother."|Baseline and EoT (up to 12 weeks)|FAS. EoT value was defined as last post-baseline assessment during the double-blind study period for which the efficacy data are available.|||units on a scale||Standard Deviation|Mean
2560998|NCT02656173|Secondary|Change From Baseline to EoT in IPSS Subscale Scores|IPSS subscale scores was calculated by following each formula. Storage subscale was derived as sum of scores for questions 2, 4, and 7 (range: 1-15). Voiding subscale-1 was derived as sum of scores for questions 3, 5, and 6 (range: 1-15). Voiding subscale-2 was derived as sum of voiding subscale-1 and the score for question 1 (range: 1-20). Individual scores and IPSS Quality of Life (QoL) score was the score of each item (range: 1-6) (Questions 1-7 and QoL item). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement.|Baseline and EoT (up to 12 weeks)|FAS. EoT value was defined as last post-baseline assessment during the double-blind study period for which the efficacy data are available.|||units on a scale||Standard Deviation|Mean
2560999|NCT02656173|Secondary|Change From Baseline to EoT in Total International Prostate Symptom Score (IPSS)|The IPSS included an 7-item questionnaire that assesses urinary frequency and incomplete voiding along with a QoL assessment. Total IPSS score was the sum total of the score (range: 0-35) of each item (Questions 1-7). Negative change means improvement.|Baseline and EoT (up to 12 weeks)|FAS. EoT value was defined as last post-baseline assessment during the double-blind study period for which the efficacy data are available.|||units on a scale||Standard Deviation|Mean
2561000|NCT02656173|Secondary|Change From Baseline to EoT in OABSS Subscale Scores|"Each OABSS subscale score was based on each question in the questionnaire: Daytime Frequency (How many times do you typically urinate from waking in the morning until sleeping at night? where scores range from 0-2), Nighttime Frequency (How many times do you typically wake up to urinate from sleeping at night until waking in the morning? where scores range from 0-3), Urgency (How often do you have a sudden desire to urinate, which is difficult to defer? where scores range from 0-5), Urgency Incontinence (How often do you leak urine because you cannot defer the sudden desire to urinate? where scores range from 0-5). A higher score is indicative of worse condition and a negative change from baseline indicates an improvement."|Baseline and EoT (up to 12 weeks)|FAS. EoT value was defined as last post-baseline assessment during the double-blind study period for which the efficacy data are available.|||units on a scale||Standard Deviation|Mean
2561001|NCT02656173|Secondary|Change From Baseline to EoT in Total Overactive Bladder Symptom Score (OABSS)|The OABSS is a 4-item questionnaire that assesses urinary frequency. Total score was the sum total of the score of each item (ranges: 0-15). Negative change means improvement.|Baseline and EoT (up to 12 weeks)|FAS. EoT value was defined as last post-baseline assessment during the double-blind study period for which the efficacy data are available.|||units on a scale||Standard Deviation|Mean
2561002|NCT02656173|Secondary|Change From Baseline to EoT in Mean Volume Voided Per Micturition|The mean volume voided per micturition was calculated from data recorded by participants on a 3-day micturition diary before each visit.|Baseline and EoT (up to 12 weeks)|FAS who had volume voided as > 0. EoT value was defined as last post-baseline assessment during the double-blind study period for which the efficacy data are available.|||mL||Standard Deviation|Mean
2561003|NCT02656173|Secondary|Change From Baseline to EoT in Mean Number of Nocturia Episodes|A nocturia episode was defined as a micturition episode initiated between night time. Night time was defined as the period between sleep onset time and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit.|Baseline and EoT (up to 12 weeks)|FAS who had at least 1 nocturia episode at baseline. EoT value was defined as last post-baseline assessment during the double-blind study period for which the efficacy data are available.|||nocturia episodes||Standard Deviation|Mean
2561004|NCT02656173|Secondary|Change From Baseline to EoT in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit.|Baseline and EoT (up to 12 weeks)|FAS who had at least 1 incontinence episode at baseline. EoT value was defined as last post-baseline assessment during the double-blind study period for which the efficacy data are available.|||incontinence episodes||Standard Deviation|Mean
2561005|NCT02656173|Secondary|Change From Baseline to EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours|An urgency incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit.|Baseline and EoT (up to 12 weeks)|FAS who had at least 1 urgency incontinence episode at baseline. EoT value was defined as last post-baseline assessment during the double-blind study period for which the efficacy data are available.|||urgency incontinence episodes||Standard Deviation|Mean
2561006|NCT02656173|Secondary|Change From Baseline to EoT in Mean Number of Urgency Episodes Per 24 Hours|An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit.|Baseline and EoT (up to 12 weeks)|FAS who had at least 1 urgency episode at baseline. EoT value was defined as last post-baseline assessment during the double-blind study period for which the efficacy data are available.|||urgency episodes||Standard Deviation|Mean
2561007|NCT02656173|Primary|Change From Baseline to Weeks 4, 8, 12 in Mean Number of Micturitions Per 24 Hours|A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit.|Baseline and week 4, 8 and 12|FAS.|||micturitions||Standard Deviation|Mean
2561008|NCT02656173|Primary|Change From Baseline to End of Treatment (EoT) in Mean Number of Micturitions Per 24 Hours|A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by participants on a 3-day micturition diary before each visit.|Baseline and EoT (up to 12 weeks)|Full analysis set (FAS) consisted of all subjects who were randomized and received ≥ 1 dose of double-blind study drug and had a baseline micturition measurement and ≥ 1 post-baseline micturition measurement. EoT value was defined as last post-baseline assessment during the double-blind study period for which the efficacy data are available.|||micturitions||Standard Deviation|Mean
2561009|NCT02656160|Secondary|Change in EMG GG for cmH2O Change in Epiglottic Pressure. (GG%Max/cmH2O)|Effect of dalfampridine on genioglossus muscle responsiveness to increased epiglottic pressure swings during sleep in healthy controls during NREM sleep. The variation of EMG GG is expressed here as % of maximal activation.|1 night||||%max/cmH2O||Inter-Quartile Range|Median
2561010|NCT02656160|Primary|Genioglossus Activity During Sleep Expressed as %Wakefulness Value (Before Drug/Placebo Administration).|The EMG GG was quantified in arbitrary units derived from signal processing of the raw signal and as a percentage of wakefulness (%wake) for between-nights comparison of baseline sleep EMG GG activity. EMG GG analysis was performed on a breath-by-breath basis to identify a maximum value and a minimum value during inspiration and expiration, respectively (EMG GG peak and tonic). The difference between peak and tonic values was used to estimate respiratory related phasic activity. Wakefulness EMG GG values were obtained from a minimum of 10 epochs (30 s each) with the subject lying in the lateral position. Criteria for breath selection during wakefulness were (1) stable breathing (constant epiglottic pressure swings) and (2) absence of movement artifacts (i.e., swallowing, speech, yawns).|1 night||||percentage of wakefulness value||Inter-Quartile Range|Median
2561011|NCT02656069|Post-Hoc|Hypoglycemia Rescue: Glucose or Symptomatic Response Definition|Number of subjects with either an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL or resolution of all neuroglycopenic symptoms of hypoglycemia within 30 minutes after administration of glucagon|At 30 minutes following administration of study drug|Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received|||Participants|||Count of Participants
2561012|NCT02656069|Secondary|Global Assessment of Hypoglycemia|Time to resolution of the overall sensation of hypoglycemia following administration of glucagon|At 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 minutes following administration of glucagon|Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received|||minutes||Standard Deviation|Mean
2561013|NCT02656069|Secondary|Time to Resolution of Hypoglycemia Symptoms|Time to resolution of mean autonomic, mean neuroglycopenic and mean total hypoglycemia symptom scores from baseline through 90 minutes following administration of glucagon.|At 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 and 90 minutes following administration of glucagon|Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received|||minutes||Standard Deviation|Mean
2561014|NCT02656069|Secondary|Plasma Glucose Time to Concentration > 70 mg/dL|Pharmacodynamic endpoint of time to achieve a plasma glucose concentration > 70 mg/dL following administration of glucagon|At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon|Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received|||minutes||Standard Deviation|Mean
2561015|NCT02656069|Secondary|Plasma Glucose Time to Maximum Concentration (Tmax)|Pharmacodynamic endpoint of plasma glucose Tmax from baseline to 4 hours following administration of glucagon|At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon|Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received|||minutes||Standard Deviation|Mean
2561016|NCT02656069|Secondary|Plasma Glucose Maximum Concentration (Cmax)|Pharmacodynamic endpoint of plasma glucose Cmax from baseline to 4 hours following administration of glucagon|At -5, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes following administration of glucagon|Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received|||mg/dL||Standard Deviation|Mean
2561017|NCT02656069|Secondary|Plasma Glucose Area Under the Curve (AUC)|Pharmacodynamic endpoint of plasma glucose AUC from baseline to 90 minutes following administration of glucagon|At -5, 0, 10, 20, 30, 45, 60, and 90 minutes following administration of glucagon|Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received|||mg*min/dL||Standard Deviation|Mean
2561018|NCT02656069|Primary|Hypoglycemia Rescue: Alternate Glucose Response Definition|Number of subjects with either an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL or an increase in from baseline in plasma glucose concentration of at least 20 mg/dL within 30 minutes after administration of glucagon|At 30 minutes following administration of study drug|Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received|||Participants|||Count of Participants
2561019|NCT02656069|Primary|Hypoglycemia Rescue: Per Protocol Population|Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon|At 30 minutes following administration of study drug|All randomized, treated subjects without a major protocol violation|||Participants|||Count of Participants
2561020|NCT02656069|Primary|Hypoglycemia Rescue: Intent-to-Treat Population|Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon|At 30 minutes following administration of study drug|Modified intent-to-treat population of all randomized subjects analyzed by actual treatment received|||Participants|||Count of Participants
2561021|NCT02655887|Secondary|Endpoint Without Hypothesis Testing: Number of Participants Without Device Stent Fracture at 12 Months Follow-Up|Stents were evaluated at the 12 month follow-up for fracture analysis. Evaluable ITT subjects are included in this analysis.|Evaluation at 12 months post-index procedure|Evaluable ITT subjects are included in this analysis. (n) varies in relation to the number of evaluable subjects. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.|||Participants|||Count of Participants
2561022|NCT02655887|Secondary|Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Vessel Revascularization (TVR) (ITT Subjects)|Freedom from Target Vessel Revascularization (TVR) is defined as the first revascularization procedure of the target vessel, as determined by an Independent Core Lab. Freedom from Target Lesion Revascularization (TLR) and Freedom from TVR results are the same through the 12 month analysis as all TLRs were also TVRs in this case.|Evaluation through 30 days, 6 months and 12 months post index procedure|(n) varies in relation to the number of evaluable subjects at 30 days, 6 months and 12 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.|||Participants|||Count of Participants
2561023|NCT02655887|Secondary|Endpoint Without Hypothesis Testing: Number of Participants With Freedom From Target Lesion Revascularization (TLR) (ITT Subjects)|Freedom from Target Lesion Revascularization (TLR) through 30 days is specific to the first revascularization procedure of the target lesion.|Evaluation throrugh 30 day, 6 months and 12 months post index procedure|(n) varies in relation to the number of evaluable subjects at 30 days, 6 months and 12 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.|||Participants|||Count of Participants
2561024|NCT02655887|Secondary|Endpoint Without Hypothesis Testing: Number of Participants With Lesion Success (ITT Subjects)|Lesion Success is defined as the attainment of less or equal to 50% residual stenosis at the conclusion of the index procedure.|At the conclusion of index procedure||||Participants|||Count of Participants
2561025|NCT02655887|Secondary|Endpoint Without Hypothesis Testing: Number of Participants With Acute Procedure Success (ITT Subjects)|Technical success is defined as no major adverse events experienced between index procedure and discharge|Less than 30 days post index procedure||||Participants|||Count of Participants
2561026|NCT02655887|Secondary|Endpoint Without Hypothesis Testing: Number of Participants With Acute Technical Success|Acute technical success is defined as successful deployment of stent(s) to intended target with adequate lesion coverage as assessed by the Investigator.|At time of Index Procedure||||Participants|||Count of Participants
2561027|NCT02655887|Secondary|Endpoint Without Hypothesis Testing: Index of CEAP at 30 Days, 6 Months, and 12 Months Post Procedure|Clinical-Etiologic-Anatomic-Pathophysiologic (CEAP) Classification is a system that describes a doctor's physical exam findings for vein problem(s), the cause of the problem(s), the location in the leg, and the mechanism responsible for the manifestation of the vein problem. For Clinical classification, the clinical components indicates disease severity, ranging from none (0 points) to active ulcers (6 points).For each category of Etiology, Anatomy, and Pathophysiology classifications, at each time point, frequency of each category is reported. Subsequent clinical study reports will present CEAP at 24 and 36-months follow-up. Changes from baseline measures to given time points are presented. Lower mean scores represent an improvement from baseline measure.|Evaluation through 30 day, 6 months and 12 months post index procedure|Evaluable ITT subjects are included in this analysis. (n) varies in relation to the number of evaluable subjects at 30 days, 6 months and 12 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.|||Scores on a scale||Standard Deviation|Mean
2561028|NCT02655887|Secondary|Endpoint With Hypothesis Testing: Index of Quality of Life (QoL) From Baseline to 12 Months|The Quality of Life (QoL) assessment of Chronic Venous Insufficiency Questionnaire (CIVIC-20) is a 20-item questionnaire which provides a global index and an outline of 4 QoL dimensions - pain (4 items), physical (4 items), psychological (9 items) and social (4 items). Items are scored on a scale from 1 to 5. A low score corresponds to greater patient comfort. Total CIVIQ-20 score is the sum of all 20-item scores The score of each dimension was obtained by adding up the scores of each constituent item within that dimension. Twelve-month data is the change between baseline score and 12-month follow-up score. Results calculated for evaluable ITT subjects. Lower values represent a better outcome, that is, a better QoL than that experienced at baseline.|Evaluation at 12 months post-index procedure|Evaluable ITT subjects were included in this analysis. (n) varies in relation to the number of evaluable subjects. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.|||Scores on a scale||95% Confidence Interval|Mean
2561029|NCT02655887|Secondary|Endpoint With Hypothesis Testing: Index of Venous Clinical Severity Score (VCSS) From Baseline to 12 Months|The Venous Clinical Severity Score (VCSS) system includes 10 clinical descriptions (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulceration, size of active ulceration. and level of compliance with medical compression therapy), scored from 0 to 3 (total possible score, 30) with 0 means absent, 1 means mild, 2 means moderate and 3 means severe. Total VCSS is the sum of all VCSS assessment scores from categories for a given time point. Twelve-month data is the change between baseline score and 12-month follow-up score. Results calculated for Intent-to-Treat (ITT) subjects. Lower values represent a better outcome, that is, a level of pain less than that experienced at baseline.|Evaluation at 12 months post-index procedure|Evaluable ITT subjects are included in this analysis.(n) varies in relation to the number of evaluable subjects. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.|||Scores on a scale||95% Confidence Interval|Mean
2561030|NCT02655887|Primary|Number of Participants With Freedom From Major Adverse Events (MAEs)|"Freedom from major adverse events (MAEs) defined as: Target Vessel Revascularization; Device and/or procedure related death; Major amputation of target limb; Pulmonary Embolism which is clinically important; Vascular injury requiring surgical/endovascular intervention; Embolization /migration of stent; Device or procedure related acute DVT involving the treated limb.~Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful."|30 days post-index procedure|ITT subjects. Results adjudicated by CEC. MAEs that occurred prior to day 30 of each subject's follow-up were counted as failures toward primary safety (n= 11). Those subjects were considered not evaluable and not included in the denominator for the primary safety endpoint (total evaluable = 170 subjects).|||Participants|||Count of Participants
2561031|NCT02655887|Primary|Number of Participants With Primary Patency of the Venous Stent at 12 Months Post-Index Procedure|"Primary patency rate at 12 months post-index procedure evaluated against a literature-derived Performance Goal (PG) of 74%. Primary patency defined as: freedom from Target Vessel Revascularization (TVR); freedom from thrombus occlusion and stenosis > 50% as measured by Duplex Ultrasound (DUS).~Please note that both the primary effectiveness and the primary safety endpoint are considered co-primary endpoints. That is, both endpoints need to be significant to claim the study as successful."|12 months post-index procedure|ITT subjects. 25 subjects were excluded from the denominator due to discontinuation or other reasons prior to 12 month follow-up visit.|||Participants|||Count of Participants
2561032|NCT02655679|Secondary|Percentage Change From Baseline in VAS Sleep Score|The participant used a 10-point VAS to evaluate loss of sleep averaged over the last 3 days where 0= None to 10=Worst imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.|Baseline (Day 0) to Day 28|mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.|||percentage change in VAS sleep score||Standard Deviation|Mean
2561033|NCT02655679|Secondary|Percentage Change From Baseline in Pruritus VAS Score|The participant used a 10-point VAS to assess the occurrence of pruritus (itchy skin) over the last 3 days where 0= None to 10=Worst Imaginable for a total possible score of 0 to 10. A negative percentage change indicates improvement.|Baseline (Day 0) to Day 28|mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.|||percentage change in pruritis VAS score||Standard Deviation|Mean
2561034|NCT02655679|Secondary|Percentage Change From Baseline Eczema Area and Severity Index (EASI)|The investigator assessed four body regions: Head and neck, Upper extremities, Trunk including axillae and groin, and Lower extremities including buttocks. Each body region was scored based on BSA where 0=No involvement to 6=90-100%. Each body region was assessed for erythema, infiltration/papulation, excoriation and lichenification using a 4-point scale where 0=None to 3=Severe. EASI total score was determined by combining the individual scores for each of the 4 body regions. The total for each region was calculated by [erythema + infiltration+ excoriation + lichenification * area involvement * a constant (constants Head and Neck=0.1, Upper Limbs=0.2, Trunk=0.3, Lower Limbs=0.4)]. The EASI total score was determined by combining the individual scores for each of the 4 body regions for a total possible score of 0 (best) to 72 (worst). A negative percentage change indicates improvement.|Baseline (Day 0) to Day 28|mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.|||percentage change in EASI||Standard Deviation|Mean
2561035|NCT02655679|Secondary|Percentage Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score|The investigator assessed severity of atopic dermatitis (AD) using scoring atopic dermatitis (SCORAD) score obtained from different individual scales. 6-items: erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness were graded on a 4-point scale where 0=Absent to 3=Severe. The individual scores were added together to get a score of 0 to 18 that was multiplied by 3.5 for a score of 0 to 63. The overall BSA affected by AD (0 to 100 %) was divided by 5 for a score 0 to 20. The participant used a 10-point Visual Analog Scale (VAS) to evaluate loss of sleep and the occurrence of pruritus averaged over the last 3 days where 0=None to Worst Imaginable. The sum of the 2 VAS scores was 0 to 20. The above measures were added together for a total possible SCORAD score of 0 (best) to 103 (worst). A negative percentage change indicates improvement.|Baseline (Day 0) to Day 28|mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.|||percentage change in SCORAD score||Standard Deviation|Mean
2561036|NCT02655679|Secondary|Percentage Change From Baseline in Investigator Global Assessments (IGA) Score|The investigator assessed the participant's atopic dermatitis using the 5-point IGA where 0=clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting) to 4=Severe disease (Deep/bright red erythema with severe induration/papulation with oozing/crusting). A negative percentage change indicates improvement.|Baseline (Day 0) to Day 28|mITT population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.|||percentage change in IGA score||Standard Deviation|Mean
2561037|NCT02655679|Secondary|Percentage Change From Baseline in Total Body Surface Area (BSA)|Percent BSA was estimated using the palmar surface of the participant's hand up to the proximal interphalangeal joint, including the thumb, to approximate 1% of the participant's BSA. The overall BSA affected by atopic dermatitis was evaluated from 0 to 100% and divided by 5 for a maximum of 20. A negative percentage change indicates improvement.|Baseline (Day 0) to Day 28|Modified intent-to-treat (mITT) population included all participants who were randomized and who received at least one dose of study medication and with a Baseline and Day 28 value for efficacy parameters.|||percentage change in total BSA||Standard Deviation|Mean
2561038|NCT02655679|Secondary|Elimination Half-life (t½) for VTP-38543||Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)|PK Population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.|||hour||Standard Deviation|Mean
2561409|NCT02650895|Secondary|Determine Plasma Drug Half Life.|To calculate the plasma CD24Fc half life.|42 days|PK evaluable population|||hr||Standard Deviation|Mean
2561039|NCT02655679|Secondary|Area Under the Plasma Concentration Versus Time Curve, From Time 0 to 12 Hours (AUC0-12hr) for VTP-38543||Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)|PK population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.|||ng*hr/mL||Standard Deviation|Mean
2561040|NCT02655679|Secondary|Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUClast) for VTP-38543||Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)|PK population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.|||ng*hr/mL||Standard Deviation|Mean
2561041|NCT02655679|Secondary|Time to Maximum Plasma Concentrations (Tmax) for VTP-38543||Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)|PK population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.|||hour||Full Range|Median
2561042|NCT02655679|Secondary|Maximum Plasma Concentration (Cmax) for VTP-38543-001||Day 0 (pre-dose, 1, 2, 4, 6, 9, and 12 hours post first dose), and Day 27 (pre-dose, 1, 2, 4, 6, 9, 12, 24, 48, and 72 hours post last dose)|Pharmacokinetic (PK) population included all participants with available plasma concentration data with profiles adequate to determine PK parameters. Number analyzed is the number of participants with serial sampling data available at the given timepoint.|||ng/mL||Standard Deviation|Mean
2561043|NCT02655679|Primary|Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values|A standard 12-lead ECG was performed. The investigator determined if the changes in ECG results were clinically significant.|Baseline (Day 0) to Day 35|Safety population included randomized participants who received at least one dose of study medication.|||Participants|||Count of Participants
2561044|NCT02655679|Primary|Number of Participants With Clinically Significant Changes in Vital Signs|Vital signs included blood pressure, pulse, respiration rate and body temperature. The investigator determined if the changes in vital sign results were clinically significant.|Baseline (Day 0) to Day 35|Safety population included randomized participants who received at least one dose of study medication.|||Participants|||Count of Participants
2561045|NCT02655679|Primary|Number of Participants With Clinically Significant Changes in Clinical Laboratory Values|Clinical Laboratory tests included chemistry, hematology and urinalysis tests collected during the study. The investigator determined if the changes in laboratory results were clinically significant.|Baseline (Day 0) to Day 35|Safety population included randomized participants who received at least one dose of study medication.|||Participants|||Count of Participants
2561046|NCT02655679|Primary|Number of Participants With Treatment-related Adverse Events (AEs)|An Adverse Event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The number of participants with AEs related to treatment are reported.|Baseline (Day 0) to Day 35|Safety population included randomized participants who received at least one dose of study medication.|||Participants|||Count of Participants
2561047|NCT02655666|Secondary|Percentage of Time in the Hyperglycemic Range|Percentage of time in the hyperglycemic range (SG≥10.0 mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual percentage of time in that range for each evaluation period.|Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).|Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).|||percentage of time||Standard Deviation|Mean
2561048|NCT02655666|Secondary|Percentage of Time in the Hypoglycemic Range|Percentage of time in the hypoglycemic range (SG ≤ 3.9 mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual percetage of time in that range for each evaluation period.|Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).|Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).|||percentage of time||Standard Deviation|Mean
2561049|NCT02655666|Secondary|Area Under Curve in the Hyperglycemic Range|Area under Curve in the hyperglycemic range (SG≥10.0 mmol/L) based on all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual Area under Curve for each evaluation period.|Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).|Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).|||mmol/L*min||Standard Deviation|Mean
2561050|NCT02655666|Secondary|Area Under Curve in the Hypoglycemic Range|Area under Curve in the hypoglycemic range (SG≤3.9mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual Area under Curve for each evaluation period.|Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).|Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).|||mmol/L*min||Standard Deviation|Mean
2561051|NCT02655666|Secondary|Number of Events in the Hyperglycemic Range|Number of Events in the Hyperglycemic Range (SG≥10.0 mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual number of events for each evaluation period.|Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).|Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).|||events||Standard Deviation|Mean
2561153|NCT02654652|Primary|Serum DAO Enzyme Concentration|The intestinal permeability using serum DAO enzyme concentration (ng/mL) was determined by sandwich enzyme-linked immunosorbent assay (ELISA) kit (SEA656Hu), according to Cloud-Clone Corporation® (Huston, TX) specifications.|7 days||||ng/mL||Full Range|Median
2561052|NCT02655666|Secondary|Number of Events in the Hypoglycemic Range|Number of events in the hypoglycemic range (SG≤3.9mmol/L) of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual number of events for each evaluation period.|Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).|Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).|||events||Standard Deviation|Mean
2561053|NCT02655666|Secondary|Mean Amplitude of Glycemic Excursion Based on Continuous Glucose Monitoring Data|"Mean Amplitude of Glycemic Excursion (which is often used to characterize glycemic variability, to know the detail of calculation, please refer to Glucose Variability, © 2013 by the American Diabetes Association. ) of each subject for each evaluation period is calculated, and then we present the mean and std of the individual Mean Amplitude of Glycemic Excursion for each evaluation period."|Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).|Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).|||mmol/L||Standard Deviation|Mean
2561054|NCT02655666|Secondary|Coefficient of Variation of Glucose Value Per Each Subject Based on Continuous Glucose Monitoring Data|The coefficient of variation of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual coefficient of variation for each evaluation period.|Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).|Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).|||percentage||Standard Deviation|Mean
2561055|NCT02655666|Secondary|Standard Deviation of Glucose Value Based on Continuous Glucose Monitoring Data|The standard deviation of all available glucose value of each subject for each evaluation period is calculated, and then we present the mean and std of the individual standard deviation for each evaluation period.|Data is collected 7 days following the end of each period (At end of month 3, no glucose data is collected.).|Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).|||mmol/L||Standard Deviation|Mean
2561056|NCT02655666|Secondary|Average Glucose Values Based on Continuous Glucose Monitoring Data|The average glucose value of all available glucose value of each subject for each evaluation period is calculated, and we present the mean and std of the individual average glucose value for each evaluation period.|Data is collected during the 7 days following the end of each period (At end of month 3, no glucose data is collected).|Subject enrolled with Continuous Glucose Monitoring (CGM) data available (Not all subjects have glucose value for analysis at each period.).|||mmol/L||Standard Deviation|Mean
2561057|NCT02655666|Primary|Change in Glycosylated Hemoglobin (A1C)|The change of A1C from baseline to end of study (1 year) will be presented|Change in A1C from baseline to end of study (1 year)|Subject completed the study.|||percent Glycosylated Hemoglobin||Standard Deviation|Mean
2561058|NCT02655510|Primary|The Number of Subjects With Unexpected Serious Adverse Events.|The count of subjects who experience serious adverse events|From day 1 up to 42 days following administration of last dose of study drug||||Participants|||Count of Participants
2561059|NCT02655419|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero up to 6 Hours [AUC(0-6)] of Avibactam (AVI) for Participants With Clinical Cure and Failure at TOC Visit: Intensive Sampling at Day 4 (mMITT Population)|AUC(0-6): area under the plasma concentration-time curve from time 0 upto the 6hrs. Clinical cure;complete resolution or significant improvement of signs and symptoms of the index infection(cIAI)such as no further antimicrobial therapy, drainage, or surgical intervention necessary and does not meet any of failure criteria. Failure: death related to intra-abdominal infection; received treatment with additional antibiotics for ongoing symptoms of cIAI; previously met criteria for failure; persisting or recurrent infection within abdomen; post-surgical wound infections included an open wound with signs of local infection such as purulent exudates, erythema, or warmth that requires additional antibiotics and/or non-routine wound care. Data of AUC(0-6) based on intensive sampling at Day4, is reported in this outcome separately and only for those participants who had clinical response of cure and failure at TOC Visit. TOC visit occurred up to a maximum of 28 days after first dose.|Plasma samples collection for AUC0-6 at: predose, 0.5 1, 2, 3, 3.25, 3.5, 3.75, 4, 5 and 6 hour postdose on Day 4 assessed for participants with cure and failure at Test of Cure Visit (up to a maximum of 28 days)|mMITTpopulation set was used in this analysis. Here, ‘Number analyzed’ = participants evaluable for this outcome measure at specified categories. AUC0-6 was assessed on Day 4 and presented in this OM, only for those participants who had clinical cure or failure at TOC visit.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561060|NCT02655419|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero up to 6 Hours [AUC(0-6)] of Aztreonam (ATM) for Participants With Clinical Cure and Failure at TOC Visit: Intensive Sampling at Day 4 (mMITT Population)|AUC(0-6): area under the plasma concentration-time curve from time 0 upto the 6hrs. Clinical cure;complete resolution or significant improvement of signs and symptoms of the index infection(cIAI)such as no further antimicrobial therapy, drainage, or surgical intervention necessary and does not meet any of failure criteria. Failure: death related to intra-abdominal infection; received treatment with additional antibiotics for ongoing symptoms of cIAI; previously met criteria for failure; persisting or recurrent infection within abdomen; post-surgical wound infections included an open wound with signs of local infection such as purulent exudates, erythema, or warmth that requires additional antibiotics and/or non-routine wound care. Data of AUC(0-6) based on intensive sampling at Day4, is reported in this outcome separately and only for those participants who had clinical response of cure and failure at TOC Visit. TOC visit occurred up to a maximum of 28 days after first dose.|Plasma samples collection for AUC0-6 at: predose, 0.5 1, 2, 3, 3.25, 3.5, 3.75, 4, 5 and 6 hour postdose on Day 4 assessed for participants with cure and failure at Test of Cure Visit (up to a maximum of 28 days)|mMITTpopulation set was used in this analysis. Here, ‘Number analyzed’ = participants evaluable for this outcome measure at specified categories. AUC0-6 was assessed on Day 4 and presented in this OM, only for those participants who had clinical cure or failure at TOC visit.|||hr*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561549|NCT02648646|Secondary|30-second Chair Stand Test|Participant rises from chair to full standing position and sits back down as quickly as possible for 30 seconds. Number of completed sit to stand to sit maneuvers is recorded.|Week 8||||completed maneuvers||Full Range|Median
2561061|NCT02655419|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero up to 6 Hours [AUC(0-6)] of Avibactam (AVI) for Participants With Clinical Cure and Failure at TOC Visit: Intensive Sampling at Day 4 (MITT Population)|AUC(0-6): area under the plasma concentration-time curve from time 0 upto the 6hrs. Clinical cure;complete resolution or significant improvement of signs and symptoms of the index infection(cIAI)such as no further antimicrobial therapy, drainage, or surgical intervention necessary and does not meet any of failure criteria. Failure: death related to intra-abdominal infection; received treatment with additional antibiotics for ongoing symptoms of cIAI; previously met criteria for failure; persisting or recurrent infection within abdomen; post-surgical wound infections included an open wound with signs of local infection such as purulent exudates, erythema, or warmth that requires additional antibiotics and/or non-routine wound care. Data of AUC(0-6) based on intensive sampling at Day4, is reported in this outcome separately and only for those participants who had clinical response of cure and failure at TOC Visit. TOC visit occurred up to a maximum of 28 days after first dose.|Plasma samples collection for AUC0-6 at: predose, 0.5 1, 2, 3, 3.25, 3.5, 3.75, 4, 5 and 6 hour postdose on Day 4 assessed for participants with cure and failure at Test of Cure Visit (up to a maximum of 28 days)|The MITT population included all enrolled participants who received any amount of study drug. Here, ‘Number analyzed’ = participants evaluable for this outcome measure at specified categories. AUC0-6 was assessed on Day 4 and presented in this OM, only for those participants who had clinical cure or failure at TOC visit.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561062|NCT02655419|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero up to 6 Hours [AUC(0-6)] of Aztreonam (ATM) for Participants With Clinical Cure and Failure at TOC Visit: Intensive Sampling at Day 4 (MITT Population)|AUC(0-6): area under the plasma concentration-time curve from time 0 upto the 6hrs. Clinical cure;complete resolution or significant improvement of signs and symptoms of the index infection(cIAI)such as no further antimicrobial therapy, drainage, or surgical intervention necessary and does not meet any of failure criteria. Failure: death related to intra-abdominal infection; received treatment with additional antibiotics for ongoing symptoms of cIAI; previously met criteria for failure; persisting or recurrent infection within abdomen; post-surgical wound infections included an open wound with signs of local infection such as purulent exudates, erythema, or warmth that requires additional antibiotics and/or non-routine wound care. Data of AUC(0-6) based on intensive sampling at Day4, is reported in this outcome separately and only for those participants who had clinical response of cure and failure at TOC Visit. TOC visit occurred up to a maximum of 28 days after first dose.|Plasma samples collection for AUC0-6 at: predose, 0.5 1, 2, 3, 3.25, 3.5, 3.75, 4, 5 and 6 hour postdose on Day 4 assessed for participants with cure and failure at Test of Cure Visit (up to a maximum of 28 days)|The MITT population included all enrolled participants who received any amount of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories. AUC0-6 was assessed on Day 4 and presented in this OM, only for those participants who had clinical cure or failure at TOC visit.|||hr*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561063|NCT02655419|Secondary|Percentage of Participants With Clinical Cure at TOC Visit: Microbiologically Modified Intent-to-Treat (mMITT) Population|Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of the index infection (cIAI) such as no further antimicrobial therapy, drainage, or surgical intervention is necessary and does not meet any of the failure criteria. Failure: death related to intra-abdominal infection; received treatment with additional antibiotics for ongoing symptoms of cIAI; previously met criteria for failure; persisting or recurrent infection within the abdomen; post-surgical wound infections included an open wound with signs of local infection such as purulent exudates, erythema, or warmth that requires additional antibiotics and/or non-routine wound care. TOC visit occurred up to a maximum of 28 days after first dose.|Test of Cure Visit (up to a maximum of 28 days)|The mMITT population included all enrolled participants who had any amount of study drug and had a diagnosis of cIAI (that is,met inclusion criterion ) and an intraabdominal pathogen at baseline. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2561064|NCT02655419|Secondary|Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit: MITT Population|Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of the index infection (cIAI) such as no further antimicrobial therapy, drainage, or surgical intervention is necessary and does not meet any of the failure criteria. Failure: death related to intra-abdominal infection; received treatment with additional antibiotics for ongoing symptoms of cIAI; previously met criteria for failure; persisting or recurrent infection within the abdomen; post-surgical wound infections included an open wound with signs of local infection such as purulent exudates, erythema, or warmth that requires additional antibiotics and/or non-routine wound care. TOC visit occurred up to a maximum of 28 days after first dose.|Test of Cure Visit (up to a maximum of 28 days)|The MITT population included all enrolled participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
2561065|NCT02655419|Primary|Number of Participants With Clinical Significant Physical Examination Findings : MITT Population|Physical examinations included an assessment of abdomen, cardiovascular, general appearance, head, eyes, ears, nose, lymph nodes, skin, musculoskeletal, neurological, respiratory systems and other (edemas). Clinically significant abnormality in physical examination was based on investigator's assessment. LFU visit occured within 20 to 24 days after last infusion.|From first dose of study drug up to the LFU visit (up to maximum of 38 days)|The MITT population included all enrolled participants who received any amount of study drug. Here, ‘number analysed’ = Participants evaluable for this outcome measure at specified categories.|||Participants|||Count of Participants
2561066|NCT02655419|Primary|Number of Participants With Clinically Significant Vital Signs|Vital sign parameters included: Supine systolic blood pressure (millimeters of mercury [mmHg]), Supine diastolic blood pressure (mmHg), Heart rate (beats per minute), Respiratory rate (breaths per minute) and body temperature (degree celsius). Criteria for clinical significance in vital signs was based on investigator's assessment. LFU visit occurred within 20 to 24 days after last infusion.|From first dose of study drug up to LFU visit (up to maximum of 38 days)|The safety analysis included all enrolled participants who received any amount of study drug.|||Participants|||Count of Participants
2561550|NCT02648646|Secondary|Hand Grip Dynamometry Left Hand|Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.|Month 6||||kilograms||Full Range|Median
2561067|NCT02655419|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities in Clinical Chemistry Paramteres|Criteria for abnormality: aspartate aminotransferase, alanine aminotransferase >3.0*ULN & >100% AB, alkaline phosphatase <0.5 *LLN & >80% BB&; >3.0*ULN & >100% AB; bilirubin >1.5*ULN & >100% AB; direct bilirubin >2.0*ULN & >150% AB; protein <0.5*LLN & >50%BB; >1.5*ULN & >50% AB, albumin <0.5*LLN & >50% BB; >1.5*ULN & >50% AB, urea nitrogen <0.2* LLN & >100% BB; >3.0*ULN & >200% AB, creatinine >2.0*ULN & >100% AB, sodium <0.85*LLN & >10% BB;>1.1*ULN &>10% AB; potassium <0.8*LLN &>20% BB; >1.2*ULN &>20% AB, chloride <0.8*LLN &>20% BB;>1.2*ULN & >20% AB, calcium <0.7*LLN & >30% BB; >1.3*ULN & >30% AB, phosphate <0.5*LLN & >50% BB; >3.0*ULN & >200% AB, bicarbonate <0.7*LLN & >40% BB; >1.3*ULN & >40% AB, glucose <0.6*LLN & >40% BB, >3.0*ULN & >200% AB. LFU visit occurred within 20 to 24 days after last infusion.|Baseline up to LFU visit (up to maximum of 38 days)|The safety analysis included all enrolled participants who received any amount of study drug. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2561068|NCT02655419|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities in Hematology Parameters|Criteria for abnormality: Hemoglobin, hematocrit, erythrocytes less than(<) 0.7*lower limit of normal [LLN] and (&) greater than (>) 30 percent (%) below baseline [BB]; >1.3*upper limit of normal [ULN] & >30% above baseline [AB], leukocytes <0.65*LLN & >60% BB; >1.6* ULN & >100% AB; platelets <0.65*LLN & >50% BB; >1.5*ULN & >100% AB; neutrophils <0.65*LLN & >75% BB; >1.6*ULN & >100% AB, lymphocytes <0.25*LLN & >75%BB; >1.5*ULN & >100% AB, basophils, eosinophils, monocytes>4.0*ULN & >300% AB. LFU visit occurred within 20 to 24 days after last infusion.|Baseline up to LFU visit (up to maximum of 38 days)|The safety analysis included all enrolled participants who received any amount of study drug. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2561069|NCT02655419|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for ECG abnormalities: QT value: greater than or equal to (>=) 450 milliseconds (msec), >=480 msec, >=500 msec, >=500 and increase from baseline >=60 msec. Increase from baseline in QT: >=30 msec, >=60 msec. Decrease from baseline in QT: >=30 msec, >=60 msec. QTcB value: >=450 msec, >=480 msec, >=500 msec, >=500 and increase from baseline >=60 msec. Increase from baseline in QT interval using Bazett's correction (QTcB) value: >=30 msec, >=60 msec. Decrease from baseline in QTcB: >=30 msec, >=60 msec. QT interval using Fridericia's correction (QTcF) value: >=450 msec, >=480 msec, >=500 msec, >=500 and increase from baseline >=60 msec. Increase from baseline in QTcF value: >=30 msec, >=60 msec. Decrease from baseline in QTcF value: >=30 msec, >=60 msec. EOT (end of treatment) visit occurred within 24 hours after last infusion.|Baseline up to EOT (up to a maximum of 15 days)|The safety analysis included all enrolled participants who received any amount of study drug.|||Participants|||Count of Participants
2561070|NCT02655419|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAEs was an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; or was an important medical event which may jeopardise the participants or require medical intervention to prevent one of the above outcomes. Treatment-emergent were events between first infusion of study drug and up to late follow-up (LFU) visit (20 to 24 days after last infusion). AEs included both non-serious AEs and SAEs.|From first dose of study drug up to the LFU visit (up to maximum of 38 days)|The safety analysis included all enrolled participants who received any amount of study drug.|||Participants|||Count of Participants
2561071|NCT02655419|Primary|Apparent Clearance (CL) of Aztreonam (ATM) and Avibactam (AVI): Intensive Sampling at Day 4|Clearance of a drug was measure of the rate at which a drug was metabolized or eliminated by normal biological processes.|predose, 0.5 1, 2, 3, 3.25, 3.5, 3.75, 4, 5 and 6 hour postdose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||liter/hour||Geometric Coefficient of Variation|Geometric Mean
2561072|NCT02655419|Primary|Volume of Distribution (Vz) of Aztreonam (ATM) and Avibactam (AVI): Intensive Sampling at Day 4|Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|predose, 0.5 1, 2, 3, 3.25, 3.5, 3.75, 4, 5 and 6 hour postdose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||liter||Standard Deviation|Geometric Mean
2561073|NCT02655419|Primary|Apparent Volume of Distribution at Steady State (Vss) of Aztreonam (ATM) and Avibactam (AVI): Intensive Sampling at Day 4|Apparent volume of distribution at steady state was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|predose, 0.5 1, 2, 3, 3.25, 3.5, 3.75, 4, 5 and 6 hour postdose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||liter||Geometric Coefficient of Variation|Geometric Mean
2561074|NCT02655419|Primary|Plasma Elimination Half-life (t1/2) of Aztreonam (ATM) and Avibactam (AVI): Intensive Sampling at Day 4|Plasma elimination half-life was defined as time measured for the plasma concentration of ATM and AVI to decrease by one half of its initial concentration.|predose, 0.5 1, 2, 3, 3.25, 3.5, 3.75, 4, 5 and 6 hour postdose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||hours||Standard Deviation|Mean
2561075|NCT02655419|Primary|Time of Last Measured Concentration (Tlast) of Aztreonam (ATM) and Avibactam (AVI): Intensive Sampling at Day 4||predose, 0.5 1, 2, 3, 3.25, 3.5, 3.75, 4, 5 and 6 hour postdose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||hours||Full Range|Median
2561076|NCT02655419|Primary|Area Under the Plasma Concentration Time Curve From Time Zero up to the Last Measured Concentration (AUC[0-last]) for Avibactam (AVI): Intensive Sampling at Day 4|AUC(0-last) was defined as the area under the plasma concentration-time curve from time zero up to the time of the last measurable concentration.|predose, 0.5 1, 2, 3, 3.25, 3.5, 3.75, 4, 5 and 6 hour postdose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||hr*ng/mL||Standard Deviation|Geometric Mean
2561077|NCT02655419|Primary|Area Under the Plasma Concentration Time Curve From Time Zero up to the Last Measured Concentration (AUC[0-last]) for Aztreonam (ATM): Intensive Sampling at Day 4|AUC(0-last) was defined as the area under the plasma concentration-time curve from time zero up to the time of the last measurable concentration.|predose, 0.5 1, 2, 3, 3.25, 3.5, 3.75, 4, 5 and 6 hour postdose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||hr*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561078|NCT02655419|Primary|Area Under the Plasma Concentration Time Curve From Time Zero up to 6 Hours (AUC[0-6]) for Avibactam (AVI): Intensive Sampling at Day 4|AUC(0-6) was defined as the area under the plasma concentration-time curve from time zero up to the six hours postdose.|predose, 0.5 1, 2, 3, 3.25, 3.5, 3.75, 4, 5 and 6 hour postdose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||hour*nanogram per milliliter (hr*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2561079|NCT02655419|Primary|Area Under the Plasma Concentration Time Curve From Time Zero up to 6 Hours (AUC[0-6]) for Aztreonam (ATM): Intensive Sampling at Day 4|AUC(0-6) was defined as the area under the plasma concentration-time curve from time zero up to the six hours postdose.|predose, 0.5 1, 2, 3, 3.25, 3.5, 3.75, 4, 5 and 6 hour postdose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||hour*microgram/milliliter (hr*mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2561080|NCT02655419|Primary|Time of Observed Maximum Concentration (Tmax) of Aztreonam (ATM) and Avibactam (AVI): Intensive Sampling at Day 4||predose, 0.5 1, 2, 3, 3.25, 3.5, 3.75, 4, 5 and 6 hour postdose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||hours||Full Range|Median
2561081|NCT02655419|Primary|Maximum Observed Plasma Concentration (Cmax) of Avibactam (AVI): Intensive Sampling at Day 4||predose, 0.5 1, 2, 3, 3.25, 3.5, 3.75, 4, 5 and 6 hour postdose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561082|NCT02655419|Primary|Maximum Observed Plasma Concentration (Cmax) of Aztreonam (ATM): Intensive Sampling at Day 4||predose, 0.5 1, 2, 3, 3.25, 3.5, 3.75, 4, 5 and 6 hour postdose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561083|NCT02655419|Primary|Plasma Concentration of Avibactam (AVI): Intensive Sampling at Day 4, 6 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.|6 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561084|NCT02655419|Primary|Plasma Concentration of Avibactam (AVI): Intensive Sampling at Day 4, 5 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.|5 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561085|NCT02655419|Primary|Plasma Concentration of Avibactam (AVI): Intensive Sampling at Day 4, 4 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.|4 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561086|NCT02655419|Primary|Plasma Concentration of Avibactam (AVI): Intensive Sampling at Day 4, 3.75 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.|3.75 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561137|NCT02655224|Secondary|Number of Participants With TEAEs Related to Standard 12-lead Electrocardiogram (ECG)|Number of participants with TEAEs of which threshold was 5% or above in either treatment group related to ECG was reported.|Up to Week 16|Safety Analysis Set included all participants who received at least 1 dose of study drug for the treatment period.|||Participants|||Count of Participants
2561087|NCT02655419|Primary|Plasma Concentration of Avibactam (AVI): Intensive Sampling at Day 4, 3.5 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.|3.5 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561088|NCT02655419|Primary|Plasma Concentration of Avibactam (AVI): Intensive Sampling at Day 4, 3.25 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.|3.25 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561089|NCT02655419|Primary|Plasma Concentration of Avibactam (AVI): Intensive Sampling at Day 4, 3 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.|3 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561090|NCT02655419|Primary|Plasma Concentration of Avibactam (AVI): Intensive Sampling at Day 4, 2 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.|2 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561091|NCT02655419|Primary|Plasma Concentration of Avibactam (AVI): Intensive Sampling at Day 4, 1 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.|1 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561092|NCT02655419|Primary|Plasma Concentration of Avibactam (AVI): Intensive Sampling at Day 4, 0.5 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.|0.5 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561093|NCT02655419|Primary|Plasma Concentration of Avibactam (AVI): Intensive Sampling at Day 4, 0 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.|Predose (0 hr) on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561094|NCT02655419|Primary|Plasma Concentration of Aztreonam (ATM): Intensive Sampling at Day 4, 6 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.|6 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561095|NCT02655419|Primary|Plasma Concentration of Aztreonam (ATM): Intensive Sampling at Day 4, 5 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.|5 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561096|NCT02655419|Primary|Plasma Concentration of Aztreonam (ATM): Intensive Sampling at Day 4, 4 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.|4 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561138|NCT02655224|Secondary|Number of Participants With TEAEs Related to Weight|Number of participants with TEAEs of which threshold was 5% or above in either treatment group related to weight was reported.|Up to Week 16|Safety Analysis Set included all participants who received at least 1 dose of study drug for the treatment period.|||Participants|||Count of Participants
2561097|NCT02655419|Primary|Plasma Concentration of Aztreonam (ATM): Intensive Sampling at Day 4, 3.75 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.|3.75 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561098|NCT02655419|Primary|Plasma Concentration of Aztreonam (ATM): Intensive Sampling at Day 4, 3.5 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.|3.5 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561099|NCT02655419|Primary|Plasma Concentration of Aztreonam (ATM): Intensive Sampling at Day 4, 3.25 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.|3.25 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561100|NCT02655419|Primary|Plasma Concentration of Aztreonam (ATM): Intensive Sampling at Day 4, 3 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.|3 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561101|NCT02655419|Primary|Plasma Concentration of Aztreonam (ATM): Intensive Sampling at Day 4, 2 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.|2 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561102|NCT02655419|Primary|Plasma Concentration of Aztreonam (ATM): Intensive Sampling at Day 4, 1 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.|1 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561103|NCT02655419|Primary|Plasma Concentration Aztreonam (ATM): Intensive Sampling at Day 4, 0.5 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.|0.5 hr Post dose on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561104|NCT02655419|Primary|Plasma Concentration Aztreonam (ATM): Intensive Sampling at Day 4, 0 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.|Predose (0 hr) on Day 4|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561105|NCT02655419|Primary|Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 4, 5 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.|5 hr Post dose on Day 4|PK population: all participants who had at least 1 plasma concentration data available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ. Intensive rather than sparse sampling was conducted for all participants in low AVI dose cohort(Cohort 1)on Day4 and hence sparse data not reported.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561106|NCT02655419|Primary|Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 4, 2.75 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.|2.75 hr Post dose on Day 4|PK population: all participants who had at least 1 plasma concentration data available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ. Intensive rather than sparse sampling was conducted for all participants in low AVI dose cohort(Cohort 1)on Day4 and hence sparse data not reported.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561107|NCT02655419|Primary|Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 4, 0 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.|Predose (0 hr) on Day 4|PK population: all participants who had at least 1 plasma concentration data available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ. Intensive rather than sparse sampling was conducted for all participants in low AVI dose cohort(Cohort 1)on Day4 and hence sparse data not reported.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561108|NCT02655419|Primary|Plasma Concentration of Aztreonam (ATM): Sparse Sampling at Day 4, 5 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.|5 hr Post dose on Day 4|PK population: all participants who had at least 1 plasma concentration data available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ. Intensive rather than sparse sampling was conducted for all participants in low AVI dose cohort(Cohort 1)on Day4 and hence sparse data not reported.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561109|NCT02655419|Primary|Plasma Concentration of Aztreonam (ATM): Sparse Sampling at Day 4, 2.75 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.|2.75 hr Post dose on Day 4|PK population: all participants who had at least 1 plasma concentration data available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ. Intensive rather than sparse sampling was conducted for all participants in low AVI dose cohort(Cohort 1)on Day4 and hence sparse data not reported.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561110|NCT02655419|Primary|Plasma Concentration of Aztreonam (ATM): Sparse Sampling at Day 4, 0 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.|Predose (0 hr) on Day 4|PK population: all participants who had at least 1 plasma concentration data available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ. Intensive rather than sparse sampling was conducted for all participants in low AVI dose cohort(Cohort 1)on Day4 and hence sparse data not reported.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561111|NCT02655419|Primary|Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 1, 5 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.|5 hr Post dose on Day 1|PK population: all participants who had at least 1 plasma concentration data available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ. Intensive rather than sparse sampling was conducted for all participants in low AVI dose cohort(Cohort 1)on Day4 and hence sparse data not reported.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561112|NCT02655419|Primary|Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 1, 3.25 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.|3.25 hr Post dose on Day 1|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561113|NCT02655419|Primary|Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 1, 0.42 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.|0.42 hr Post dose on Day 1|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561114|NCT02655419|Primary|Plasma Concentration of Avibactam (AVI): Sparse Sampling at Day 1, 0 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 nanogram per milliliter (ng/ml).|Predose (0 hr) on Day 1|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2561115|NCT02655419|Primary|Plasma Concentrations of Aztreonam (ATM): Sparse Sampling at Day 1, 5 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.|5 hr Post dose on Day 1|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561139|NCT02655224|Secondary|Number of Participants With Markedly Abnormal Values of Vital Signs|Vital signs included sitting blood pressure (after the participant has rested for at least 5 minutes), body temperature (oral or tympanic measurement) (degree Celsius [°C]) and pulse (beats per minute [bpm]) are reported.|Up to Week 16|Safety Analysis Set included all participants who received at least 1 dose of study drug for the treatment period.|||Participants|||Count of Participants
2561116|NCT02655419|Primary|Plasma Concentrations of Aztreonam (ATM): Sparse Sampling at Day 1, 3.25 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.|3.25 hr Post dose on Day 1|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561117|NCT02655419|Primary|Plasma Concentration of Aztreonam (ATM): Sparse Sampling at Day 1, 0.42 hr|All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.|0.42 hr Post dose on Day 1|The PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2561118|NCT02655419|Primary|Plasma Concentration of Aztreonam (ATM): Sparse Sampling at Day 1, 0 hr|All participants were to have sparse pharmacokinetics (PK) sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above lower limit of quantification (LLOQ). LLOQ for ATM was 0.1 microgram per milliliter (mcg/ml).|Predose (0 hr) on Day 1|PK population included all participants who had at least 1 plasma concentration data assessment available for ATM-AVI. Here, Overall number of participants analyzed signifies participants who had observations above LLOQ.|||microgram per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2561119|NCT02655237|Secondary|Number of Participants With TEAE Related to Biochemical Bone Metabolism Markers|Number of participants with TEAEs of which threshold was 5% or above in either treatment group related to biochemical bone metabolism markers was reported.|Up to Week 28|Safety analysis set included all participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
2561120|NCT02655237|Secondary|Number of Participants With TEAE (Bone Density Decreased) Related to Bone Mineral Density|Number of participants with TEAEs of which threshold was 5% or above in either treatment group related to bone mineral density was reported.|Up to Week 28|Safety analysis set included all participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
2561121|NCT02655237|Secondary|Number of Participants With Markedly Abnormal Values of Laboratory Test|Number of participants with any markedly abnormal values in laboratory tests collected throughout study is reported. WBC = White blood cells, AST = Aspartate Aminotransferase, ALT = Alanine Aminotransferase, GGT = gamma-glutamyl transferase, ULN = upper limit of normal or upper reference limit.|Up to Week 28|Safety analysis set included all participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
2561122|NCT02655237|Secondary|Number of Participants With TEAE Related to Standard 12-Lead ECGs|Number of participants with TEAEs of which threshold was 5% or above in either treatment group related to ECG was reported.|Up to Week 28|Safety analysis set included all participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
2561123|NCT02655237|Secondary|Number of Participants With TEAE Related to Weight|Number of participants with TEAEs of which threshold was 5% or above in either treatment group related to weight was reported.|Up to Week 28|Safety analysis set included all participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
2561124|NCT02655237|Secondary|Number of Participants With Markedly Abnormal Values of Vital Signs|Vital signs included sitting blood pressure (after the participant has rested for at least 5 minutes), body temperature (oral or tympanic measurement) (degree Celsius [°C]) and pulse (beats per minute [bpm]) is reported.|Up to Week 28|Safety analysis set included all participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
2561125|NCT02655237|Secondary|Number of Participants Who Had One or More Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to Week 28|Safety analysis set included all participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
2561126|NCT02655237|Secondary|Change From Baseline in Uterine Fibroid Symptom and Quality of Life (UFS-QOL)- HRQL Total Scores at Weeks 4, 8, 12, 16, 20, 24 and Follow-up|UFS-QOL was a 37-item self-reporting tool for evaluating QOL in participants with uterine fibroid. It includes eight symptom-related questions and 29 HRQL questions across six subscales (concern, activities, energy/mood, control, self-consciousness, sexual function). The total HRQL score is ranging from 0 to 100. The higher scores indicate better QOL.|Baseline, Weeks 4, 8, 12, 16, 20, 24 and Follow-up (up to Week 28)|FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
2561127|NCT02655237|Secondary|Change From Baseline in Uterine Fibroid Symptom and Quality of Life (UFS-QOL)- Symptom Severity Score at Weeks 4, 8, 12, 16, 20, 24 and Follow-up|UFS-QOL was a 37-item self-reporting tool for evaluating QOL in participants with uterine fibroid. It includes eight symptom-related questions and 29 HRQL questions across six subscales (concern, activities, energy/mood, control, self-consciousness, sexual function). The total symptom severity score is ranging from 0 to 100. The higher scores indicate greater severity.|Baseline, Weeks 4, 8, 12, 16, 20, 24 and Follow-up (up to Week 28)|FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
2561128|NCT02655237|Secondary|Numerical Rating Scale (NRS) Score|Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain.|From Week 6 to 12, from Week 2 to 6, from Week 18 to 24, and for 6 weeks before the final dose (up to Week 24)|FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
2561129|NCT02655237|Secondary|Change From Baseline in Hemoglobin at Weeks 4, 8, 12, 16, 20, 24 and Follow up|Anemia-related measurements consisted of hemoglobin, which were determined at the central laboratory.|Baseline, Weeks 4, 8, 12, 16, 20, 24 and Follow up (up to Week 28)|FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point.|||g/dL||Standard Deviation|Mean
2561130|NCT02655237|Secondary|Percent Change From Baseline in Uterine Volumes at Weeks 2, 4, 8, 12 and 24|"A transvaginal ultrasound was performed for determination of uterine volumes. On the assumption that the uterus was spheroids, the uterine volumes were calculated using 3 diameters (D1, D2, and D3) measured as shown below: D1: the longest diameter of the uterus (unit of length: cm); D2: the longest diameter of the uterus which was perpendicular to D1 (unit of length: cm); D3: the diameter of the uterus which crossed the intersection of D1 and D2 (intersection Z) and was perpendicular to D1/D2 plane (unit of length: cm). The formula used for calculation is Uterine volume=D1*D2*D3*π/6."|Baseline, Weeks 2, 4, 8, 12 and 24|FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point.|||cm^3||Standard Deviation|Mean
2561131|NCT02655237|Secondary|Percent Change From Baseline in Myoma Volumes at Weeks 2, 4, 8, 12 and 24|"A transvaginal ultrasound was performed to determine myoma volumes. Only the largest myoma among those measurable at visit 1 was measured throughout the study. On the assumption that the myoma was spheroids, the myoma volumes were calculated using 3 diameters (D1, D2, and D3). D1: the longest diameter of the myoma; D2: the longest diameter of the myoma which was perpendicular to D1; D3: the diameter of the myoma which crossed the intersection of D1 and D2 (intersection Z) and was perpendicular to D1/D2 plane. The formula used for calculation is Myoma volume= D1*D2*D3*π/6."|Baseline, Weeks 2, 4, 8, 12 and 24|FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point.|||cm^3||Standard Deviation|Mean
2561132|NCT02655237|Secondary|Percentage of Participants With Total PBAC Score of <10 for 6 Weeks Before the Final Dose of Study Drug|PBAC score was used to measure volume of menstrual blood loss. Participants used sanitary products designated by sponsor and recorded the numbers of tampons or towels used, clots and flooding in patient diary. Three diagrams used which represented a lightly, moderately stained or completely saturated pad/tampon. Following scores assigned: 1) 1, 5, or 20 points for each pad; 2) 1, 5, or 10 points for each tampon; 3) 1 or 5 points for each blood clot of <1 cm/=1 cm/>1 in longest diameter; 4) 5 points for each episode of flooding. The total PBAC score (sum of points) ranges from 0 to >500.|For 6 weeks before the final dose of study drug (up to Week 24)|FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of participants|||Number
2561133|NCT02655237|Secondary|Percentage of Participants With Total PBAC Score of <10 From Week 18 to 24|PBAC score was used to measure volume of menstrual blood loss. Participants used sanitary products designated by sponsor and recorded the numbers of tampons or towels used, clots and flooding in patient diary. Three diagrams used which represented a lightly, moderately stained or completely saturated pad/tampon. Following scores assigned: 1) 1, 5, or 20 points for each pad; 2) 1, 5, or 10 points for each tampon; 3) 1 or 5 points for each blood clot of <1 cm/=1 cm/>1 in longest diameter; 4) 5 points for each episode of flooding. The total PBAC score (sum of points) ranges from 0 to >500.|Week 18 to 24|FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of participants|||Number
2561134|NCT02655237|Secondary|Percentage of Participants With Total PBAC Score of <10 From Week 2 to 6|PBAC score was used to measure volume of menstrual blood loss. Participants used sanitary products designated by sponsor and recorded the numbers of tampons or towels used, clots and flooding in patient diary. Three diagrams used which represented a lightly, moderately stained or completely saturated pad/tampon. Following scores assigned: 1) 1, 5, or 20 points for each pad; 2) 1, 5, or 10 points for each tampon; 3) 1 or 5 points for each blood clot of <1 cm/=1 cm/>1 in longest diameter; 4) 5 points for each episode of flooding. The total PBAC score (sum of points) ranges from 0 to >500.|Week 2 to 6|FAS included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of participants|||Number
2561135|NCT02655237|Primary|Percentage of Participants With Total PBAC Score of <10 From Week 6 to 12|PBAC score was used to measure volume of menstrual blood loss. Participants used sanitary products designated by sponsor and recorded the numbers of tampons or towels used, clots and flooding in patient diary. Three diagrams used which represented a lightly, moderately stained or completely saturated pad/tampon. Following scores assigned: 1) 1, 5, or 20 points for each pad; 2) 1, 5, or 10 points for each tampon; 3) 1 or 5 points for each blood clot of <1 cm/=1 cm/>1 in longest diameter; 4) 5 points for each episode of flooding. The total PBAC score (sum of points) ranges from 0 to >500.|Week 6 to 12|Full analysis set (FAS) included all participants who were randomized and received at least 1 dose of the study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of participants|||Number
2561136|NCT02655224|Secondary|Number of Participants With Markedly Abnormal Values of Laboratory Tests|Number of participants with any markedly abnormal values in laboratory tests collected throughout study is reported. WBC = White blood cells, GGT = gamma-glutamyl transferase, LLN = lower limit of normal or lower reference limit, ULN = upper limit of normal or upper reference limit.|Up to Week 16|Safety Analysis Set included all participants who received at least 1 dose of study drug for the treatment period.|||Participants|||Count of Participants
2561140|NCT02655224|Secondary|Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to Week 16|Safety Analysis Set included all participants who received at least 1 dose of study drug for the treatment period.|||Participants|||Count of Participants
2561141|NCT02655224|Secondary|Percentage of Days Without Pain Symptoms (NRS = 0) From Day 1 to 28, From Day 29 to 56, and From Day 57 to 84|Percentage of day without pain symptoms (NRS = 0) was reported. Number of days without pain symptoms is determined by a zero score on the NRS. Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain. Percentage of days without pain symptoms (NRS=0) (%) = [(number of days without pain symptoms (NRS=0) during the last 28 days of the treatment)/(number of days with available data during the last 28 days of the treatment)]*100.|Day 1 to 28, Day 29 to 56, and Day 57 to 84|FAS included all participants who were randomized and received at least 1 dose of study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of days||Standard Deviation|Mean
2561142|NCT02655224|Secondary|Mean NRS Score From Day 1 to 28, From Day 29 to 56, and From Day 57 to 84|Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain.|Day 1 to 28, Day 29 to 56, and Day 57 to 84|FAS included all participants who were randomized and received at least 1 dose of study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
2561143|NCT02655224|Secondary|Percentage of Participants With a Maximum NRS Score of 0 From Day 1 to 28, From Day 29 to 56, and From Day 57 to 84|Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain. The percentage of participants with a score of 0 is reported.|Day 1 to 28, Day 29 to 56, and Day 57 to 84|FAS included all participants who were randomized and received at least 1 dose of study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of participants|||Number
2561144|NCT02655224|Secondary|Percentage of Participants With Maximum NRS Score of 1 or Less From Day 1 to 28, From Day 29 to 56, and From Day 57 to 84|Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain. The percentage of participants with a score of 1 or less is reported.|Day 1 to 28, Day 29 to 56, and Day 57 to 84|FAS included all participants who were randomized and received at least 1 dose of study drug for the treatment period. The number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of participants|||Number
2561145|NCT02655224|Secondary|Percentage of Days Without Pain Symptoms (NRS = 0) During the 28 Days Before the Final Dose of Study Drug|Percentage of day without pain symptoms (NRS = 0) was reported. Number of days without pain symptoms is determined by a zero score on the NRS. Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain. Percentage of days without pain symptoms (NRS=0) during the 28 days before the final dose of study drug (%) = [(number of days without pain symptoms (NRS=0) during the last 28 days of the treatment)/(number of days with available data during the last 28 days of the treatment)]*100.|For 28 days before the final dose of study drug (up to Week 12)|FAS included all participants who were randomized and received at least 1 dose of study drug for the treatment period.|||percentage of days||Standard Deviation|Mean
2561146|NCT02655224|Secondary|Mean NRS Score During the 28 Days Before the Final Dose of Study Drug|Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain.|For 28 days before the final dose of study drug (up to Week 12)|FAS included all participants who were randomized and received at least 1 dose of study drug for the treatment period.|||score on a scale||Standard Deviation|Mean
2561147|NCT02655224|Secondary|Percentage of Participants With a Maximum NRS Score of 0 During the 28 Days Before the Final Dose of Study Drug|Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain. The percentage of participants with a score of 0 is reported.|For 28 days before the final dose of study drug (up to Week 12)|FAS included all participants who were randomized and received at least 1 dose of study drug for the treatment period.|||percentage of participants|||Number
2561148|NCT02655224|Primary|Percentage of Participants With a Maximum NRS Score of 1 or Less During the 28 Days Before the Final Dose of Study Drug|Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain. The percentage of participants with a score of 1 or less is reported.|For 28 days before the final dose of study drug (up to Week 12)|Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of study drug for the treatment period.|||percentage of participants|||Number
2561149|NCT02654782|Secondary|Alveolar-arterial Gradient|Alveolar-arterial gradient will be calculated from arterial blood gases on each patient. This value will be used to compare shunt in each arm.|Calculated throughout the study up to 6 hours in the ICU|The study was terminated early. This was a student project and the student performing the study left Mayo Clinic and there were no funds to continue study. Targeted enrollment of 40 subjects was not met and data was not analyzed.||||||
2561150|NCT02654782|Primary|Total Fluid Administered Indexed to Weight|Adequate fluid volume plays a major part in maintaining the necessary hemodynamics to prevent organ damage during cardiac surgery. This will be measured by the total volume of fluid administered to the subject from the start of surgery up to 6 hours in the intensive care unit.|Start of surgery up to 6 hours into the intensive care unit (ICU)|The study was terminated early. This was a student project and the student performing the study left Mayo Clinic and there were no funds to continue study. Targeted enrollment of 40 subjects was not met and data was not analyzed.||||||
2561154|NCT02654639|Primary|Length of Progression-Free Survival|Disease progression will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI.|From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years.|The study was terminated early due to recruitment difficulties. 4 subjects were enrolled but no outcomes data was collected and no analysis was performed.||||||
2561155|NCT02654483|Secondary|Change in Mean NRS Itch Score During Bathing/Dressing Changes|"Itch is exacerbated by activities such as dressing changes or bathing. NRS itch score during bathing or dressing in the past 24 hours were collected. Numeric rating scale (NRS) for itch severity is comprised of one item and represents the numbers 0 (no itch) to 10 (worst imaginable itch). This study was designed to detect differences between the two treatment groups. This secondary endpoint was the comparative change in Numeric Rating Scale (NRS) itch severity score during bathing/dressing changes from baseline over 8 weeks as determined by application of a linear mixed effects model."|Baseline and 8 weeks|The relative effect of drug on the mean change in NRS itch severity score during dressing changes as compared to baseline is calculated and serves as the secondary endpoint.|||score on a scale||95% Confidence Interval|Mean
2561156|NCT02654483|Secondary|Wound Healing Determination|Wound dimensions, including length, width, and area (in cm2), will be obtained using the Canfield system. Changes in dimensions between visits as well as changes in dimensions from baseline will be recorded. Overall mean % change from baseline is reported as the secondary endpoint.|Baseline and 8 weeks|Eligible participants were: age 13 and older with a clinical diagnosis of EB and a Numeric Rating Scale (NRS) score for pruritus of ≥4 at baseline on average itch or itch during bathing or dressing in the past 24 hours. Patients were required to have itch symptoms lasting ≥6 weeks that did not respond well to the current standard of care.|||percentage change||Standard Deviation|Mean
2561157|NCT02654483|Primary|Comparative Weekly Change in NRS Itch Score Over the 8-week Active Treatment Period|"Determine the efficacy of Serlopitant compared with placebo on reducing EB-associated daily itch score as measured by patient self-reports using a numeric rating scale (NRS) for itch severity.The NRS is comprised of one item and represents the numbers 0 (no itch) to 10 (worst imaginable itch). Because itch is subjective and can vary day to day, nightly NRS scores were recorded in patients' Itch Diaries. NRS recorded by subject daily, from screening visit through the end of the study.~This study was designed to detect differences between the two treatment groups. The primary endpoint was the comparative weekly change in Numeric Rating Scale (NRS) itch severity score from baseline over 8 weeks; derived from a linear mixed effects model which utilizes observations from both the treatment and placebo groups to generate an interaction term of interest. Itch severity changes from day to day and this model can more appropriately report trends in patients' itch severity with treatment."|Baseline and 8 weeks|The relative effect of drug on the mean daily change in NRS itch severity score as compared to baseline is calculated and serves as the primary endpoint. Data is reported as point/week change (delta) in NRS itch score.|||score/week comparative change||95% Confidence Interval|Mean
2561158|NCT02654314|Secondary|Number of Delirium Anti-psychotic Drug Doses Utilized for Delirium During the First 14 Days of Hospitalization.|Number of delirium anti-psychotic drug doses given for symptoms of delirium. Presented are the number of doses per days of hospitalization.|length of hospitalization, not to exceed 14 days||||number of doses per days of hospitalizat||Full Range|Median
2561159|NCT02654314|Secondary|Days Utilizing Restraints|Days utilizing restraints is defined as the number of days restraints were applied because of delirium in the first 14 days of hospitalization.|length of hospitalization, not to exceed 14 days||||days||Full Range|Median
2561160|NCT02654314|Secondary|Length of Hospital Stay|Length of stay is defined as the total time hospitalized for the acute illness (in days).|from day of admission to completion of acute care, not to exceed 30 days||||days||Standard Deviation|Mean
2561161|NCT02654314|Primary|Delirium|Delirium is defined by the Short Form Confusion Assessment Method (CAM). There must be inattention and either an acute or fluctuating course plus either disorganized thinking or an altered level of consciousness to be diagnosed with delirium. Presented is a count of individuals with reported delirium during hospitalization.|length of hospitalization, not to exceed 14 days||||Participants|||Count of Participants
2561162|NCT02654145|Secondary|Ratio to Baseline in Blood Eosinophil Count at Week 32|Blood samples were collected at specific time points to measure blood eosinophils level for evaluation of pharmacodynamic effects in participants with a severe eosinophilic asthma phenotype when they were directly switched to mepolizumab. Baseline was defined as the latest available assessment prior to first dose of mepolizumab and ratio to Baseline at Week 32 was defined as Week 32 value divided by Baseline value and was analyzed using Mixed Model Repeated Measures allowing for covariates of region, Baseline maintenance oral corticosteroid (OCS) therapy, exacerbations in the year prior to the study (as an ordinal variable) and visit. The log transformation was applied to blood eosinophil counts prior to analysis. If a blood eosinophil count of zero was reported, it was imputed with half of the lowest possible blood eosinophil count, where applicable, prior to log transforming the data. The dispersion measure used was log standard error.|Baseline and at Week 32|Intent to treat- all participants who received at least one dose of mepolizumab|||Ratio||Standard Error|Least Squares Mean
2561163|NCT02654145|Secondary|The Rate of Clinically Significant Asthma Exacerbations Over 32 Weeks' Treatment|Clinically significant exacerbations of asthma were defined as worsening of asthma which requires use of systemic corticosteroids and/or hospitalization and/or Emergency Department (ED) visits. The frequency of clinically significant asthma exacerbations over 32 weeks' treatment was analyzed using Negative Binomial Regression via generalized estimating equations with a covariate of time period (pre-treatment versus on- and off treatment).|Up to Week 32|Intent to treat - all participants who received at least one dose of mepolizumab|||Exacerbation rate per year|||Number
2561171|NCT02653872|Primary|Pharmacokinetics (PK) of AZD7986 by Assessment of the Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F).|To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.|Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||Litres||Standard Deviation|Mean
2561164|NCT02654145|Secondary|Mean Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Score at Week 32|The SGRQ Questionnaire is a well-established, self-completed tool, comprising of 50 questions with 76 weighted responses designed to measure Quality of Life in participants with diseases of airway obstruction. It consists of two parts; Part 1 produces the symptom score and Part 2 produces the activity and impact score. A Total score is also calculated which summarizes the impact of the disease on overall health status. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and zero indicates best possible health status. Baseline was defined as the latest available assessment prior to first dose of mepolizumab. Change from Baseline at Week 32 was calculated as Week 32 value of SGRQ score minus Baseline value and was analyzed using Mixed Model Repeated Measures allowing for covariates of region, baseline maintenance OCS therapy, exacerbations in the year prior to the study (as an ordinal variable) and visit.|Baseline and at Week 32|Intent to treat - all participants who received at least one dose of mepolizumab|||Scores on a scale||Standard Error|Least Squares Mean
2561165|NCT02654145|Primary|Mean Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 32|The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. The five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response options for all these questions range from zero (no impairment/limitation) to six (total impairment/ limitation) scale. ACQ-5 score range from 0 to 6. Higher scores indicates worsening of condition. Baseline was defined as the latest available assessment prior to first dose of mepolizumab. Change from Baseline at Week 32 was calculated as Week 32 value of ACQ-5 score minus Baseline value and was analyzed using Mixed Model Repeated Measures allowing for covariates of region, baseline maintenance OCS therapy, exacerbations in the year prior to the study (as ordinal variable) and visit.|Baseline and at Week 32|Intent to treat - all participants who received at least one dose of mepolizumab|||Scores on a scale||Standard Error|Least Squares Mean
2561166|NCT02654132|Secondary|Overall Survival (OS)|OS is the time from randomization to the date of death from any cause. The survival time for subjects who had not died was censored at the last known alive date. OS was censored at the date of randomization for subjects who were randomized but had no follow-up. NOTE: This data is immature and will be analyzed again at time of LPLV final.|Approximately 32 months||2020-04-30|04/2020||||
2561167|NCT02654132|Secondary|Objective Response Rate (ORR)|ORR is the proportion of randomized subjects who achieve a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator's assessment CR: Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR: CR, as defined above, plus the following: Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein level plus urine M-protein level < 100 mg per 24 hour; PR: >= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90% or to < 200 mg per 24 hour.|Approximately 14 months|All randomized participants|||Proportion of participants|||Number
2561168|NCT02654132|Primary|Progression-free Survival (PFS)|"PFS will be defined as the time, in months, from randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following:~1. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder"|Approximately 14 months|All randomized participants|||Months||95% Confidence Interval|Median
2561169|NCT02653872|Primary|Assessment of the Tmax of Verapamil, Itraconazole and OH-itraconazole Following Co-administration of AZD7986 With Verapamil or Itraconazole.|To assess the time to reach maximum observed concentration of Verapamil, Itraconazole and OH-itraconazole (a metabolite of itraconazole) following co-administration of AZD7986 with Verapamil or Itraconazole.|Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||hours||Full Range|Median
2561170|NCT02653872|Primary|Assessment of the Area Under the Plasma Concentration-curve Over the Dosing Interval (AUC [0 - τ]) of Verapamil, Itraconazole and OH-itraconazole Following Co-administration of AZD7986 With Verapamil or Itraconazole.|To assess the area under the plasma concentration-time curve from time over the dosing interval tau (24 hours) of Verapamil, itraconazole and OH-itraconazole (a metabolite of Itraconazole) following co-administration of AZD7986 with Verapamil or Itraconazole.|Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2561182|NCT02653625|Secondary|Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)|An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, regardless of whether related to the medicinal (investigational) product. A TEAE was defined as an AE with an onset that occurred after receiving treatment.|Baseline (Day 1) to Week 24|Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
2561172|NCT02653872|Primary|Pharmacokinetics (PK) of AZD7986 by Assessment of the Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (CL/F).|To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.|Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||L/h||Standard Deviation|Mean
2561173|NCT02653872|Primary|Pharmacokinetics (PK) of AZD7986 by Assessment of the Time to Reach Maximum Plasma Concentration (Tmax)|To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.|Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||hours||Full Range|Median
2561174|NCT02653872|Primary|Pharmacokinetics (PK) of AZD7986 by Assessment of Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz).|To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.|Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||hours||Standard Deviation|Mean
2561175|NCT02653872|Primary|Pharmacokinetics (PK) of AZD7986 by Assessment of the Area Under Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-t]).|To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.|Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2561176|NCT02653872|Primary|Effect of Verapamil and the Effect of Itraconazole on the PK of AZD7986 by Assessment of the Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC).|To assess the effect of verapamil and itraconazole on the PK of AZD7986.|Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2561177|NCT02653872|Primary|Effect of Verapamil and the Effect of Itraconazole on the PK of AZD7986 by Assessment of the Observed Maximum Plasma Concentration (Cmax).|To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.|Period 1,2&3: Day1 (AZD7986),Day5 (AZD7986+Verapamil) & Day6 (AZD7986): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12,24,48,72,96,120 & 144 hours post-dose; Period 3: Day6 (Itraconazole): pre-dose,0.25,0.5,0.75,1,1.5,2,3,4,5,8,9,12 & 24 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and for whom at least 1 of the primary PK parameters for AZD7986 could be calculated for at least 1 treatment period, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2561178|NCT02653768|Secondary|40m Fast-paced Walk|The 40m fast-paced walk is a timed test of walking twice back and forth (as fast as participants are able) over a 10m distance. Lower scores mean better outcome (e.g. faster walking speed).|Change from baseline to 9-month follow-up|Intent to treat|||seconds||Standard Error|Mean
2561179|NCT02653768|Secondary|30-second Chair Stand|The 30 second stair stand asks participants to rise and sit back down in a chair as many times as they can during that time period, without using hands or arms for support. Higher scores mean better outcome (e.g. more stands in 30 seconds).|Change from baseline to 9-month follow-up|Intent to treat|||Number of chair stands||Standard Error|Mean
2561180|NCT02653768|Primary|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)|This is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), with items rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms). The total scale range is 0-96, and higher scores mean a worse outcome.|Change from baseline to 3-month, 6-month, 9-month follow-ups. For STEP-KOA only, change from 9-month to 15-month follow-up.|Intent to treat. Only the STEP-KOA group was assessed at 15 months. This was planned because the AE group could start receiving treatment after 9 months.|||units on a scale||Standard Error|Mean
2561181|NCT02653625|Secondary|Percentage of Participants Who Discontinued Due to a TEAE|An adverse event was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, regardless of whether related to the medicinal (investigational) product. A TEAE was defined as an AE with an onset that occurred after receiving treatment.|Baseline (Day 1) to Week 24|Safety Analysis Set: All enrolled participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
2561551|NCT02648646|Secondary|Hand Grip Dynamometry Left Hand|Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.|Week 8||||kilograms||Full Range|Median
2561183|NCT02653625|Secondary|Percentage of Participants Who Achieved a 50% Decrease in ALP at Week 24|ALP was used as a primary surrogate marker for measuring Primary Sclerosing Cholangitis disease.|Week 24|ITT Population: All enrolled participants who received at least 1 dose of study treatment. Participants who did not return for any post-baseline visits were not included in the efficacy measurements. Number of participants analyzed are the participants with available data at the given time-point.|||percentage of participants|||Number
2561184|NCT02653625|Secondary|Percentage of Participants Who Achieved Serum ALP of Less Than 1.5 Times Upper Limit of Normal (ULN) in Serum ALP at Week 24|ALP was used as a primary surrogate marker for measuring Primary Sclerosing Cholangitis disease. The upper limit of normal ALP was defined according to the central laboratory reference ranges.|Week 24|ITT Population: All enrolled participants who received at least 1 dose of study treatment. Participants who did not return for any post-baseline visits were not included in the efficacy measurements. Number of participants analyzed are the participants with available data at the given time-point.|||percentage of participants|||Number
2561185|NCT02653625|Secondary|Percentage of Participants Who Normalized ALP at Week 24|ALP was used as a primary surrogate marker for measuring Primary Sclerosing Cholangitis disease. Normalization was defined as ALP values outside of the central laboratory reference range at baseline, but within the central laboratory reference range at Week 24.|Week 24|ITT Population: All enrolled participants who received at least 1 dose of study treatment. Participants who did not return for any post-baseline visits were not included in the efficacy measurements. Number of participants analyzed are the participants with available data at the given time-point.|||percentage of participants|||Number
2561186|NCT02653625|Primary|Percentage Change From Baseline Through Week 24 in Serum Alkaline Phosphatase (ALP)|ALP was used as a primary surrogate marker for measuring Primary Sclerosing Cholangitis disease. The percent change from Baseline was defined as 100*(value at each visit - Baseline value)/Baseline value. The Baseline value was defined as the last non-missing value on or before the Baseline visit (Day 1). A negative percentage change from baseline indicates an improvement.|Baseline (Day 1) to Week 24|ITT Population: All enrolled participants who received at least 1 dose of study treatment. Participants who did not return for any post-baseline visits were not included in the efficacy measurements. Number of participants analyzed are the participants with available data at the given time-point.|||percentage change in ALP||Standard Deviation|Mean
2561187|NCT02653560|Primary|24-hour Average Systolic Blood Pressure|Systolic blood pressure was measured through an ambulatory blood pressure monitoring device worn by each participant for 24 hours after completing each treatment phase. This devise measures blood pressure intermittently throughout the day and night and provides the average of all readings.|4 weeks||||mmHg||Standard Deviation|Mean
2561188|NCT02653495|Secondary|Antibody Response D90|Measured by hemagglutination inhibition assay|90 days after vaccination compare to day 28|Data were not collected.||||||
2561189|NCT02653495|Secondary|Gene Expression Profiling D90|Analyze by RNA-seq|90 days post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)|Data were not collected.||||||
2561190|NCT02653495|Secondary|Gene Expression Profiling D28|Analyze by RNA-seq|28 days post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)|Data were not collected.||||||
2561191|NCT02653495|Secondary|Gene Expression Profiling D1|Analyze by RNA-seq|1 day post-vaccination compare to baseline (gene expression screening visit #1 and study visit #1 D0 of vaccination)|Data were not collected.||||||
2561192|NCT02653495|Primary|Antibody Response D28|Measured by hemagglutination inhibition assay|28 days after vaccination compare to baseline (screening visit 1) pre-vaccination|Data were not collected||||||
2561193|NCT02653456|Secondary|Number of Participants With Target Lesion Revascularization|Number of participants with target lesion revascularization as determined by physician evaluation|6 months||||Participants|||Count of Participants
2561194|NCT02653456|Secondary|Number of Participants With Target Lesion Revascularization|Number of participants with target lesion revascularization as determined by physician evaluation|30 days||||Participants|||Count of Participants
2561195|NCT02653456|Secondary|Number of Participants With no Device-related Major Adverse Events|Number of participants with no device-related major adverse events as determined by physician evaluation|at time of procedure, up to an hour||||Participants|||Count of Participants
2561196|NCT02653456|Primary|Crossing the Target Lesion|Crossing the target lesion based on angiographic analysis|at time of procedure||||Participants|||Count of Participants
2561197|NCT02653417|Secondary|Change From Baseline to Week 4 and Week 12 in the Frequency of All Hot Flashes|Change from baseline to week 4 and week 12 in the average number of all hot flashes (mild, moderate, and severe) by eDiary, where change is calculated as week 4 or week 12 minus baseline so that negative values indicate a reduction (improvement) of hot flash frequency.|Baseline, 4 weeks, and 12 weeks|mITT population|||hot flashes per day||Standard Deviation|Mean
2561198|NCT02653417|Secondary|Change From Baseline to Week 4 and Week 12 in the Severity of Hot Flashes|"Change from baseline to week 4 and week 12 in the average daily severity of hot flashes, where change is calculated as week 4 or week 12 minus baseline so that negative values indicate a reduction (improvement) of hot flash severity.~Subjects recorded the number of hot flashes per day using an electronic diary. Daily severity score for hot flashes for each subject was calculated as the sum of the number of mild hot flashes, plus 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of mild, moderate, and severe hot flashes. That is,~Daily Severity Score = (Fmild + 2•Fmod + 3•Fsev)/(Fmild + Fmod + Fsev) where Fmild= frequency of mild hot flashes, Fmod = frequency of moderate hot flashes, Fsev = frequency of severe hot flashes.~The measure is a weighted average of the frequencies of Hot Flashes."|Baseline, 4 weeks, and 12 weeks|mITT population|||hot flash severity score per day||Standard Deviation|Mean
2561199|NCT02653417|Secondary|Change From Baseline to Week 4 in the Frequency of Moderate to Severe Hot Flashes|Change from baseline to week 4 in the average number of moderate and severe hot flashes per day, where change is calculated as week 4 minus baseline so that negative values indicate a reduction (improvement) of hot flash frequency.|Baseline and 4 weeks|mITT population|||moderate to severe hot flashes per day||Standard Deviation|Mean
2561270|NCT02652468|Secondary|Incidence of Graft Failure|Graft failure - defined as < 5% donor chimerism in the CD3 and/or CD33 selected cell populations at any time during the study follow up period once initial engraftment has been achieved. Will be analyzed using KM method.|Up to 1 year after graft|||||||
2561200|NCT02653417|Primary|Change From Baseline to Week 12 in the Frequency of Moderate to Severe Hot Flashes|"Change from baseline to week 12 in the average number of moderate and severe hot flashes per day, where change is calculated as week 12 minus baseline so that negative values indicate a reduction (improvement) of hot flash frequency.~Severity of hot flashes was self-assessed and reported as follows:~Mild: sensation of heat without sweating~Moderate: sensation of heat with sweating, able to continue activity~Severe: sensation of heat with sweating, causing cessation of activity."|Baseline and 12 weeks|The modified intent to treat (mITT) population was used. This included all patients in the safety population who had recorded hot flash data in their eDiaries for at least 5 days during baseline and for at least one day while on double-blind study medication, and was the primary analysis population for all efficacy analyses|||moderate to severe hot flashes per day||Standard Error|Least Squares Mean
2561201|NCT02653326|Secondary|Number of Participants With Adverse Events at 8 Weeks|Development of adverse events during exercise, such as myocardial ischemia or malignant arrhythmias.|8 weeks after randomisation||||Participants|||Count of Participants
2561202|NCT02653326|Secondary|Number of Participants With Adverse Events at 4 Weeks|Development of adverse events during exercise, such as myocardial ischemia or malignant arrhythmias.|4 weeks after randomisation||||Participants|||Count of Participants
2561203|NCT02653326|Primary|Exercise Capacity|Exercise Capacity Assessed as Peak Oxygen Consumption at 8 weeks after randomisation|8 weeks after randomisation|Outcome assessment after telerehabilitation phase was completed. These are complete-case analyses only. Results using multiple imputation techniques for missing data are given below.|||mL/Kg/minute||Standard Deviation|Mean
2561204|NCT02653326|Primary|Exercise Capacity Assessed as Peak Oxygen Consumption at 4 Weeks After Randomisation|Ergospirometric assessment of oxygen consumption (VO2) among study participants.|4 weeks after randomisation|Ergospirometric evaluations were conducted after the initial physiotherapy phase was completed amongst study participants.|||mL/Kg/minute||Standard Deviation|Mean
2561205|NCT02653183|Secondary|Pain Level Before and During Dressing Removal|"Different adhesive on the dressings, can any difference be identified during dressing removal.~Pain level before dressing removal and pain level during dressing removal. Only measured on the last visit, with this point, the patient has not so much pain from the hip/knee joint replacement, which can have an effect on the result of dressing removal pain VAS scale (0-100 mm) 0= No pain, 100= Moste intense pain imainable."|Day 7||||units on a scale||Standard Deviation|Mean
2561206|NCT02653183|Secondary|Local/Systemic Infection|Local/systemic infection? Yes/No|0-5 days||||participants|||Number
2561207|NCT02653183|Secondary|Patients Mobility After Operation|4 point rating scale ( poor, good, very good,excellent)|0-5 days||||participants|||Number
2561208|NCT02653183|Secondary|Nurses/Doctors Satisfaction With Applying the Dressing|4 point rating scale ( poor, good, very good,excellent)|0-5 days||||participants|||Number
2561209|NCT02653183|Secondary|Patients Satisfaction With Wearing the Dressing|4 point rating scale ( poor, good, very good,excellent)|0-5 days||||participants|||Number
2561210|NCT02653183|Secondary|Itching Feeling Under the Dressing|Itching feeling under the dressing? Yes/No|0-5 days||||participants|||Number
2561211|NCT02653183|Secondary|Dressings Adherence to the Staples/Sutures|Dressings adherence to the staples/sutures? Yes/No|0-5 days||||participants|||Number
2561212|NCT02653183|Primary|Composite Variable Ranging From 0 to 7, Combining Complications (Dressing Failure) Related Surgical Wound, Computed as: 3*(Dressing Change) + 2*Blister + (Pain>=30mm) + Redness on the Skin Under the Dressing|Scale range from 0 (no dressing failure) to 7 ( complete dressing failure).|0-5 days||||participants|||Number
2561213|NCT02653170|Other Pre-specified|PROMIS Informational Support Scale (Caregiver).|A validated 4-item questionnaire measuring informational support. Informational support is defined as the perceived availability of helpful information or advice.|90-days post discharge|||||||
2561214|NCT02653170|Other Pre-specified|PROMIS Emotional Support Scale (Caregiver).|A validated 4-item questionnaire measuring emotional support. Emotional support is defined as the perceived feeling of being cared for and valued as a person.|90-days post discharge|||||||
2561215|NCT02653170|Other Pre-specified|Unhealthy Days (Caregiver)|Number of days in the past 30 days that the caregiver reported that their own physical or mental health had not been good.|90-days post discharge|||||||
2561216|NCT02653170|Other Pre-specified|Oberst Caregiver Burden Scale (OCBS) (Caregiver)|Validated 15-item questionnaire measuring caregiver burden in response to providing care to stroke survivors.|90 day post discharge|||||||
2561217|NCT02653170|Other Pre-specified|Home Time (Patient)|Total number of days spent at home since discharge back to home.|90 day post discharge|||||||
2561218|NCT02653170|Other Pre-specified|Stroke Recurrence (Patient)|New onset acute stroke events requiring hospital admission|90 day post discharge|||||||
2561219|NCT02653170|Other Pre-specified|Hospital Readmission (Patient)|Unscheduled hospital admissions|90 day post discharge|||||||
2561220|NCT02653170|Other Pre-specified|Depression Symptoms (PHQ-9) (Patient)|Validated 9-item questionnaire to identify depressive symptoms.|90 day post discharge|||||||
2561221|NCT02653170|Other Pre-specified|NeuroQOL Anxiety Scale (Patient)|Validated QOL scale measuring patient anxiety (administered by computer adaptive testing).|90 day post discharge|||||||
2561222|NCT02653170|Secondary|Change From Baseline (7-days Post Discharge) to 90-days in Depression Symptoms (PHQ-9) (Caregiver)|The Patient Health Questionnaire (PHQ-9) measures severity of depression symptoms. PHQ-9 is a 9-item measure using a four-point Likert scale (not at all, several days, more than half the days, nearly every day). Response items are summed (range 0-27) with higher scores indicating the respondent is experiencing more symptoms of depression.|7 days and 90 days post discharge|Number of observations used in the analysis are larger than indicated above since all available 7-day and 90-day data were utilized (n=265)|||change in PHQ-9 score||Standard Error|Least Squares Mean
2561239|NCT02652780|Secondary|Change From Baseline in ETDRS Total Macular Volume at Week 48 and Week 96|Early Treatment Diabetic Retinopathy Study (ETDRS) total macular volume was measured as a parameter of spectral domain-optical coherence tomography (SD-OCT). SD-OCT was obtained with the Spectralis® OCT (Heidelberg Engineering).|Baseline and Week 48; Baseline and Week 96|All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit (Week 48 or Week 96). All participants received both GS010 and Sham simultaneously.|||mm^3|Eyes|Standard Error|Least Squares Mean
2561223|NCT02653170|Secondary|Change From Baseline (7-days Post Discharge) to 90-days in the Patient Activation Measure Scores (Patient)|Patient questionnaire to assess knowledge, skills, and self-efficacy for managing one's own healthcare. Patient Activation Measure is a 13-item survey using a five-point Likert scale (strongly disagree, disagree, agree, strongly agree, NA) whose response items are summed and converted to an activation score ranging from 0-100. Higher scores indicate a higher level of activation.|7 days and 90 days post discharge|Number of observations used in the analysis are larger than indicated above since all available 7-day and 90-day data were utilized (n=413)|||change in PAM score||Standard Error|Least Squares Mean
2561224|NCT02653170|Primary|Change From Baseline (7-days Post Discharge) to 90-days in the Bakas Caregiving Outcomes Scale Scores (Caregiver)|Instrument designed to measure perceived caregiver life changes in response to providing care to stroke survivors. Bakas is a 15-item measure using a rating scale with 7 points ranging from -3 (changed for the worse) to +3 (changed for the best); responses are converted to a 1-7 scale and summed (range 15-105). Higher scores indicate more positive changes resulting from caregiving experience whereas lower scores indicate negative changes.|7 days and 90 days post discharge|Number of observations used in the analysis are larger than indicated above since all available 7-day and 90-day data were utilized (n=263)|||change in score||Standard Error|Least Squares Mean
2561225|NCT02653170|Primary|Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Mental Health T-scores (Patient)|Patient-centered questionnaire of 10 self-reported items addressing the 2 main quality-of-life domains of physical and mental health which include physical health, physical function, pain, fatigue, quality of life, mental health, satisfaction with social activities, and emotional problems. PROMIS Global-10 Mental Health Quality-of-Life is a 4-item subscale measuring general aspects of physical health using a five-point Likert scale with higher scores reflecting better quality-of-life. Raw scores are summed and converted to a T-score which has a population mean score of 50 with standard deviation of 10; higher scores indicate better QOL (0-100).|7 days and 90 days post discharge|Number of observations used in the analysis are larger than indicated above since all available 7-day and 90-day data were utilized (n=434)|||change in T-score||Standard Error|Least Squares Mean
2561226|NCT02653170|Primary|Change From Baseline (7-days Post Discharge) to 90-days in the PROMIS-10 Global Quality of Life, Physical Health T-scores (Patient)|Patient-centered questionnaire of 10 self-reported items addressing the 2 main quality-of-life domains of physical and mental health which include physical health, physical function, pain, fatigue, quality of life, mental health, satisfaction with social activities, and emotional problems. PROMIS Global-10 Physical Health Quality-of-Life is a 4-item subscale measuring general aspects of physical health using a five-point Likert scale with higher scores reflecting better quality-of-life. Raw scores are summed and converted to a T-score which has a population mean score of 50 with standard deviation of 10; higher scores indicate better QOL (0-100).|7 days and 90 days post discharge|Number of observations used in the analysis are larger than indicated above since both available 7-day and 90-day values were utilized (n=434)|||change in T-score||Standard Error|Least Squares Mean
2561227|NCT02652949|Secondary|Safety and Effectiveness Outcome|"Safety and Effectiveness outcome measures between implant procedure and 60 months. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.~Measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month."|60 Month||2023-12-31|12/2023||||
2561228|NCT02652949|Secondary|Safety and Effectiveness Outcome|"Safety and Effectiveness outcome measures between implant procedure and 48 months. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.~Measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month."|48 Month||2022-12-31|12/2022||||
2561229|NCT02652949|Secondary|Safety and Effectiveness Outcome|"Safety outcome measures between 0-1095 days and Effectiveness outcome measures between 731-1095 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.~Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month."|36 Month||2021-12-31|12/2021||||
2561230|NCT02652949|Secondary|Safety and Effectiveness Outcome|"Safety outcome measures between 0-730 days and Effectiveness outcome measures between 366-730 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.~Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month."|24 Month||2020-12-31|12/2020||||
2561231|NCT02652949|Secondary|Safety and Effectiveness Outcome|"Safety outcome measures between 0-365 days and Effectiveness outcome measures between 184-365 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.~Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month."|12 Month|Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).|||Participants|||Count of Participants
2561271|NCT02652468|Secondary|Incidence of Chronic GVHD|The cumulative incidence of severe chronic GVHD by Day +180 will be recorded. Will be analyzed using KM method. Chronic GVHD will be obtained from the KM estimates along with 95% confidence intervals.|Day +180|||||||
2561232|NCT02652949|Secondary|Safety and Effectiveness Outcome|"Safety outcome measures between 0-183 days and Effectiveness outcome measures between 31-183 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.~Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month."|6 month|"Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International Trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US).~Note that 6-month follow up is not mandatory for subjects enrolled under the Valiant Evo International protocol, resulting in fewer subjects analyzed at 6 months."|||Participants|||Count of Participants
2561233|NCT02652949|Secondary|Safety and Effectiveness Outcome|"Safety and Effectiveness outcome measures between 0-30 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US [OUS]).~Measures include: peri-operative mortality, adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, and endoleaks."|30 Days|Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).|||Participants|||Count of Participants
2561234|NCT02652949|Primary|Composite Safety and Effectiveness Endpoint That is Based on the Percentage of Subjects Who Experienced (a) Access and/or Deployment Failures; and/or (b) Major Device Effect (MDE) Within 30 Days Post Index Procedure|"MDEs include: device-related secondary procedures, device-related mortality, conversion to open surgery, thoracic aortic aneurysm rupture.~Access failure: Inability to insert device due to mechanical failure or anatomic exclusions of the femoral or iliac arteries.~Deployment failure: Deployment failure due to subject anatomy or mechanical failure. Specifically, deployment of the stent graft from the delivery system.~Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects. The poolability on the primary endpoint between US and OUS data were assessed using Fisher's exact test."|30 Days|The 30-day primary endpoint was evaluated for PMA approval when 87 subjects completed 30 day follow-up.|||Participants|||Count of Participants
2561235|NCT02652780|Secondary|Change From Baseline in Color Vision|"The assessment of color vision was measured using the Farnsworth-Munsell 100-Hue Color Test. Each of the 4 trays consisted of 21 caps. Participants were asked to sort the randomly arranged caps following the hue order from the first to the last fixed caps. The total error score (TES) was derived by the frequency the caps were misplaced and the severity, or distance of the misplacement.~Errors were made whenever caps were misplaced from the correct order. Error scores were calculated according to the distance between any two caps. The error score for each individual cap was the sum of the difference between the number of that cap and the numbers of the cap adjacent to it, minus 2. TES was the total sum of the error scores of the entire set of caps.~The best possible score was 0 and there is no defined upper limit to the total error score range. A lower score indicates improved color discrimination ability. A negative change from baseline indicates an improvement in symptoms."|Baseline and Week 48; Baseline and Week 96|All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit (Week 48 or Week 96). All participants received both GS010 and Sham simultaneously.|||score on a scale|Eyes|Standard Deviation|Mean
2561236|NCT02652780|Secondary|Change From Baseline in Contrast Sensitivity at Week 48 and Week 96|"The assessment of contrast sensitivity was measured using the Pelli-Robson chart. The chart uses letters arranged in groups whose contrast varies from high to low. Participants read the letters, starting with the highest contrast, until they are unable to read 2 or 3 letters in a single group. Each eye is assigned a score based on the contrast of the last group in which 2 or 3 letters were correctly read, ranging from 0 to 2.2 log of contrast sensitivity (LogCS) units. A score of 2.0 LogCS, represents a normal sensitivity contrast, and indicates the eye was able to detect 2 of the 3 letters with a contrast of 1 percent (contrast sensitivity = 100 percent or log 2). Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents in visual disability. A positive change from baseline indicates improvement in symptoms."|Baseline and Week 48; Baseline and Week 96|All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit (Week 48 or Week 96). All participants received both GS010 and Sham simultaneously.|||LogCS|Eyes|Standard Error|Least Squares Mean
2561237|NCT02652780|Secondary|Visual Field Mean Deviation in Decibels of Sensitivity Obtained With HVF Analyzer II at Week 48 and Week 96|The assessment of standardized automated visual fields was measured using the Humphrey Visual Field (HVF) Analyzer II. Automated visual fields included the assessment of the mean deviation (MD) in decibels (dB) of sensitivity.|Baseline, Week 48 and Week 96|All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit (Week 48 or Week 96). All participants received both GS010 and Sham simultaneously.|||decibels (dB)|Eyes|Standard Deviation|Mean
2561238|NCT02652780|Secondary|Change From Baseline in the Foveal Threshold Sensitivities Obtained With HVF Analyzer II at Week 48 and Week 96|The assessment of standardized automated visual fields was measured using the Humphrey Visual Field (HVF) Analyzer II. Automated visual fields included the assessment of foveal threshold sensitivities. Foveal threshold sensitivity is measured in decibels (dB), which ranges from 0 dB to 50 dB. A sensitivity threshold of 0 dB indicates not being able to see the most intense perimetric stimulus, while higher dB indicates better/normal foveal vision. A positive change from baseline indicates an improvement of symptoms.|Baseline and Week 48; Baseline and Week 96|All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit (Week 48 or Week 96). All participants received both GS010 and Sham simultaneously.|||decibels (dB)|Eyes|Standard Deviation|Mean
2561272|NCT02652468|Secondary|Incidence of Grade III-IV Acute GVHD as Determined by IBMTR Severity Index Criteria|The cumulative incidence of grade III - IV acute Graft versus host disease (GVHD) by Day +100 will be determined. Will be analyzed using KM method. Acute GVHD will be obtained from t he KM estimates along with 95% confidence intervals.|Day +100|||||||
2561240|NCT02652780|Secondary|Change From Baseline in Papillomacular Bundle Thickness at Week 48 and Week 96|Papillomacular bundle thickness was measured as a parameter of spectral domain-optical coherence tomography (SD-OCT). SD-OCT was obtained with the Spectralis® OCT (Heidelberg Engineering).|Baseline and Week 48; Baseline and Week 96|All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit (Week 48 or Week 96). All participants received both GS010 and Sham simultaneously.|||µm|Eyes|Standard Error|Least Squares Mean
2561241|NCT02652780|Secondary|Change From Baseline in RNFL Temporal Quadrant Thickness at Week 48 and Week 96|Retinal nerve fiber layer (RNFL) temporal quadrant thickness was measured as a parameter of spectral domain-optical coherence tomography (SD-OCT). SD-OCT was obtained with the Spectralis® OCT (Heidelberg Engineering).|Baseline and Week 48; Baseline and Week 96|All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit (Week 48 or Week 96). All participants received both GS010 and Sham simultaneously.|||µm|Eyes|Standard Error|Least Squares Mean
2561242|NCT02652780|Secondary|Change From Baseline in GCL Macular Volume at Week 48 and Week 96|Ganglion cell layer (GCL) macular volume was measured as a parameter of spectral domain-optical coherence tomography (SD-OCT). SD-OCT was obtained with the Spectralis® OCT (Heidelberg Engineering).|Baseline and Week 48; Baseline and Week 96|All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit (Week 48 or Week 96). All participants received both GS010 and Sham simultaneously.|||mm^3|Eyes|Standard Error|Least Squares Mean
2561243|NCT02652780|Secondary|Number of Subject Responders to Treatment at Week 48 and Week 96|A subject responder was defined as a participant whose Early Treatment Diabetic Retinopathy Study (ETDRS) score of the treated eye (that received GS010), was at least 15 letters better than the sham eye, or whose treated eye had a logarithm of the minimal angle of resolution (logMAR) acuity score of at least 0.3 logMAR better than the sham eye.|Week 48 and Week 96|All participants that received study treatments, with data at the applicable post dose visit (Week 48 or Week 96). All participants received both GS010 and Sham simultaneously.|||Participants|||Count of Participants
2561244|NCT02652780|Secondary|Number of Eye Responders to Treatment at Week 48 and Week 96|"An eye was determined as a responder to treatment based on 2 different definitions.~Definition 1: An eye responder was defined by an improvement of the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of at least 15 letters compared to Baseline, or a final visual acuity greater than a Snellen acuity equivalent of 20/200 (a score of at least 1 letter).~Definition 2: An eye responder was defined by an improvement of the ETDRS score of at least 20 letters compared to Baseline."|Baseline; Week 48 and Week 96|All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit (Week 48 or Week 96). All participants received both GS010 and Sham simultaneously.|||Eyes|Eyes||Count of Units
2561245|NCT02652780|Secondary|Change From Baseline in ETDRS Visual Acuity (Quantitative Score) at Week 96|"Visual acuity was derived from the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The visual acuity logarithm of the minimal angle of resolution (LogMAR) score was derived from the number of letters participants could read on the ETDRS chart.~1 ETDRS line = 5 letters~1 ETDRS line = 0.1 LogMAR~A lower LogMAR score denotes better visual acuity and a negative change from baseline indicates an improvement in visual acuity.~Change = (Week 96 score - Baseline score)."|Baseline and Week 96|All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit (Week 96). All participants received both GS010 and Sham simultaneously.|||LogMAR||Standard Error|Least Squares Mean
2561246|NCT02652780|Primary|Change From Baseline in ETDRS Visual Acuity (Quantitative Score) at Week 48|"Visual acuity was derived from the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The visual acuity logarithm of the minimal angle of resolution (LogMAR) score was derived from the number of letters participants could read on the ETDRS chart.~1 ETDRS line = 5 letters~1 ETDRS line = 0.1 LogMAR~A lower LogMAR score denotes better visual acuity and a negative change from baseline indicates an improvement in visual acuity.~Change = (Week 48 score - Baseline score)."|Baseline and Week 48|All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit (Week 48). All participants received both GS010 and Sham simultaneously.|||LogMAR|Eyes|Standard Error|Least Squares Mean
2561247|NCT02652767|Secondary|Change From Baseline in Color Vision|"The assessment of color vision was measured using the Farnsworth-Munsell 100-Hue Color Test. Each of the 4 trays consisted of 21 caps. Participants were asked to sort the randomly arranged caps following the hue order from the first to the last fixed caps. The total error score (TES) was derived by the frequency the caps were misplaced and the severity, or distance of the misplacement.~Errors were made whenever caps were misplaced from the correct order. Error scores were calculated according to the distance between any two caps. The error score for each individual cap was the sum of the difference between the number of that cap and the numbers of the cap adjacent to it, minus 2. TES was the total sum of the error scores of the entire set of caps.~The best possible score was 0 and there is no defined upper limit to the total error score range. A lower score indicates improved color discrimination ability. A positive change from baseline indicates a worsening in symptoms."|Baseline; Week 48 and Week 96|Intent-to-treat (ITT) population: All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit. 1 participant was excluded from the ITT population due to receiving a smaller volume of study treatment than specified in the protocol. Participants received GS010 and Sham simultaneously.|||score on a scale|Eyes|Standard Deviation|Mean
2561256|NCT02652767|Secondary|Number of Eye Responders to Treatment|"An eye was determined as a responder to treatment based on 2 different definitions.~Definition 1: An eye responder was defined by an improvement of the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score of at least 15 letters compared to Baseline, or a final visual acuity greater than a Snellen acuity equivalent of 20/200 (a score of at least 1 letter).~Definition 2: An eye responder was defined by an improvement of the ETDRS score of at least 20 letters compared to Baseline."|Baseline; Week 48; Week 72 and Week 96|Intent-to-treat (ITT) population: All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit. 1 participant was excluded from the ITT population due to receiving a smaller volume of study treatment than specified in the protocol. Participants received GS010 and Sham simultaneously.|||Eyes|Eyes||Count of Units
2561552|NCT02648646|Secondary|Hand Grip Dynamometry Left Hand|Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.|Baseline||||kilograms||Full Range|Median
2561248|NCT02652767|Secondary|Change From Baseline in Contrast Sensitivity|"The assessment of contrast sensitivity was measured using the Pelli-Robson chart. The chart uses letters arranged in groups whose contrast varies from high to low. Participants read the letters, starting with the highest contrast, until they are unable to read 2 or 3 letters in a single group. Each eye is assigned a score based on the contrast of the last group in which 2 or 3 letters were correctly read, ranging from 0 to 2.2 log of contrast sensitivity (LogCS) units. A score of 2.0 LogCS, represents a normal sensitivity contrast, and indicates the eye was able to detect 2 of the 3 letters with a contrast of 1 percent (contrast sensitivity = 100 percent or log 2). Scores less than 2.0 signify poorer contrast sensitivity. Pelli-Robson contrast sensitivity score of less than 1.5 is consistent with visual impairment and a score of less than 1.0 represents in visual disability. A negative change from baseline indicates worsening in symptoms."|Baseline; Week 48; Week 72 and Week 96|Intent-to-treat (ITT) population: All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit. 1 participant was excluded from the ITT population due to receiving a smaller volume of study treatment than specified in the protocol. Participants received GS010 and Sham simultaneously.|||LogCS|Eyes|Standard Error|Least Squares Mean
2561249|NCT02652767|Secondary|Visual Field Mean Deviation in Decibels of Sensitivity Obtained With HVF Analyzer II|The assessment of standardized automated visual fields was measured using the Humphrey Visual Field (HVF) Analyzer II. Automated visual fields included the assessment of the mean deviation (MD) in decibels (dB) of sensitivity.|Baseline; Week 48; Week 72 and Week 96|Intent-to-treat (ITT) population: All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit. 1 participant was excluded from the ITT population due to receiving a smaller volume of study treatment than specified in the protocol. Participants received GS010 and Sham simultaneously.|||decibels (dB)|Eyes|Standard Deviation|Mean
2561250|NCT02652767|Secondary|Change From Baseline in the Foveal Threshold Sensitivities Obtained With HVF Analyzer II|The assessment of standardized automated visual fields was measured using the Humphrey Visual Field (HVF) Analyzer II. Automated visual fields included the assessment of foveal threshold sensitivities. Foveal threshold sensitivity is measured in decibels (dB), which ranges from 0 dB to 50 dB. A sensitivity threshold of 0 dB indicates not being able to see the most intense perimetric stimulus, while higher dB indicates better/normal foveal vision. A positive change from baseline indicates an improvement of symptoms.|Baseline; Week 48; Week 72 and Week 96|Intent-to-treat (ITT) population: All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit. 1 participant was excluded from the ITT population due to receiving a smaller volume of study treatment than specified in the protocol. Participants received GS010 and Sham simultaneously.|||decibels (dB)|Eyes|Standard Deviation|Mean
2561251|NCT02652767|Secondary|Change From Baseline in ETDRS Total Macular Volume|Early Treatment Diabetic Retinopathy Study (ETDRS) total macular volume was measured as a parameter of spectral domain-optical coherence tomography (SD-OCT). SD-OCT was obtained with the Spectralis® OCT (Heidelberg Engineering).|Baseline; Week 48; Week 72 and Week 96|Intent-to-treat (ITT) population: All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit. 1 participant was excluded from the ITT population due to receiving a smaller volume of study treatment than specified in the protocol. Participants received GS010 and Sham simultaneously.|||mm^3|Eyes|Standard Error|Least Squares Mean
2561252|NCT02652767|Secondary|Change From Baseline in RNFL Papillomacular Bundle Thickness|Papillomacular bundle thickness was measured as a parameter of spectral domain-optical coherence tomography (SD-OCT). SD-OCT was obtained with the Spectralis® OCT (Heidelberg Engineering).|Baseline; Week 48; Week 72 and Week 96|Intent-to-treat (ITT) population: All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit. 1 participant was excluded from the ITT population due to receiving a smaller volume of study treatment than specified in the protocol. Participants received GS010 and Sham simultaneously.|||µm|Eyes|Standard Error|Least Squares Mean
2561253|NCT02652767|Secondary|Change From Baseline in RNFL Temporal Quadrant Thickness|Retinal nerve fiber layer (RNFL) temporal quadrant thickness was measured as a parameter of spectral domain-optical coherence tomography (SD-OCT). SD-OCT was obtained with the Spectralis® OCT (Heidelberg Engineering).|Baseline; Week 48; Week 72 and Week 96|Intent-to-treat (ITT) population: All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit. 1 participant was excluded from the ITT population due to receiving a smaller volume of study treatment than specified in the protocol. Participants received GS010 and Sham simultaneously.|||µm|Eyes|Standard Error|Least Squares Mean
2561254|NCT02652767|Secondary|Change From Baseline in GCL Macular Volume|Ganglion cell layer (GCL) macular volume was measured as a parameter of spectral domain-optical coherence tomography (SD-OCT). SD-OCT was obtained with the Spectralis® OCT (Heidelberg Engineering).|Baseline; Week 48; Week 72 and Week 96|Intent -to-treat (ITT) population: All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit. 1 participant was excluded from the ITT population due to receiving a smaller volume of study treatment than specified in the protocol. Participants received GS010 and Sham simultaneously.|||mm^3|Eyes|Standard Error|Least Squares Mean
2561255|NCT02652767|Secondary|Number of Subject Responders to Treatment|"A subject responder was defined as a participant whose Early Treatment Diabetic Retinopathy Study (ETDRS) score of the treated eye (that received GS010), was at least 15 letters better than the sham eye, or whose treated eye had a logarithm of the minimal angle of resolution (LogMAR) acuity score of at least 0.3 LogMAR better than the sham eye.~For the Week 96 analysis, if no score was available for Week 96, the score from the previous visit was used."|Week 48; Week 72 and Week 96|Intent-to-treat (ITT) population: All participants that received study treatments, with data at the applicable post-dose visit. 1 participant was excluded from the ITT population due to receiving a smaller volume of study treatment than specified in the protocol. Participants received GS010 and Sham simultaneously.|||Participants|||Count of Participants
2561268|NCT02652468|Secondary|Progression-free Survival|Progression-free survival will be analyzed using KM method.|Time before any progression by either PET/CT or bone marrow, assessed up to 1 year|||||||
2561269|NCT02652468|Secondary|Treatment-related Mortality|Time to treatment-related mortality - defined as death from any cause other than disease progression - will be analyzed using KM method|Up to 1 year after graft|||||||
2561257|NCT02652767|Secondary|Change From Baseline in ETDRS Visual Acuity (Quantitative Score)|"Visual acuity was derived from the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Visual acuity is measured in logarithm of the minimal angle of resolution (LogMAR), which was derived from the number of letters participants could read on the ETDRS chart.~1 ETDRS line = 5 letters~1 ETDRS line = 0.1 LogMAR~A lower LogMAR score denotes better visual acuity. A positive change from baseline indicates a worsening in symptoms.~Change = (Week 72 score - Baseline score) or (Week 96 score - Baseline score). Missing data was imputed by the linear interpolation method."|Baseline; Week 72 and Week 96|Intent-to-treat (ITT) population: All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit. 1 participant was excluded from the ITT population due to receiving a smaller volume of study treatment than specified in the protocol. Participants received GS010 and Sham simultaneously.|||LogMAR|Eyes|Standard Error|Least Squares Mean
2561258|NCT02652767|Primary|Change From Baseline in ETDRS Visual Acuity (Quantitative Score) at Week 48|"Visual acuity was derived from the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Visual acuity is measured in logarithm of the minimal angle of resolution (LogMAR), which was derived from the number of letters participants could read on the ETDRS chart.~1 ETDRS line = 5 letters~1 ETDRS line = 0.1 LogMAR~A lower LogMAR score denotes better visual acuity. A positive change from baseline indicates a worsening in symptoms.~Change = (Week 48 score - Baseline score)."|Baseline and Week 48|Intent-to-treat (ITT) population: All participants and all eyes that received study treatments, with data at both Baseline and the applicable post-dose visit. 1 participant was excluded from the ITT population due to receiving a smaller volume of study treatment than specified in the protocol. Participants received GS010 and Sham simultaneously.|||LogMAR|Eyes|Standard Error|Least Squares Mean
2561259|NCT02652624|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||cells/µL||Standard Deviation|Mean
2561260|NCT02652624|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2561261|NCT02652624|Primary|Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the US FDA-Defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2561262|NCT02652481|Primary|Percentage of Participants That Decrease in LV ( Left Ventricle) Sensed Amplitude|Decreases in average LV sensed amplitude pre-MR scan and 1 Month post-MR scan were calculated for subjects. Subjects were considered a success if the average sensed amplitude at the MRI + 1 Month Visit remained ≥ 5.0 mV and above 50% of the average pre-MR scan value. Subjects who had an average pre-scan LV sensed amplitude measurement < 5.0 mV were excluded from this analysis.|The time between the MR Scan and MRI + 1 Month|did not include subjects with a MNS between implant and the MRI + 1 Month Visit;failed to meet labeled MRI Conditions of Use, had lead-related complication;had an incomplete scan or no scan; missing lead measurements; missed a visits, subject died or withdrew consent; Average LV sensed amplitude <5mV (3 patients)|||percentage of participants with succes||95% Confidence Interval|Number
2561263|NCT02652481|Primary|Percentage of Participants That Had a Decrease in RV ( Right Ventricle) Sensed Amplitude|Decreases in RV sensed amplitude pre-MR scan and 1 Month post-MR scan were calculated for subjects. Subjects were considered a success if the average sensed amplitude at the MRI + 1 Month Visit remains ≥ 5.0 mV and above 50% of the pre-MR scan value. Subjects who had an average pre-scan RV sensed amplitude measurement < 5.0 mV were excluded from this analysis.|The time between the MR Scan and MRI + 1 Month|Did not include subjects that had a MNS between implant and the MRI+1Month Visit; Failed to meet Conditions of Use; Experienced lead-related complication; Had an incomplete scan or no scan, died or withdrew consent, missed a visit, missed lead measurements; had an average pre-scan RV sensed amplitude measurement < 5.0 mV.|||percentage of participants with succes||95% Confidence Interval|Number
2561264|NCT02652481|Primary|Percentage of Participants That Had an Increase in Average LV ( Left Ventricle) Pacing Threshold ≤ 1.0V (Volt) at 0.5 ms.|Increases in average LV pacing threshold (at 0.5 ms) pre- MR scan and 1 Month post-MR scan were calculated for subjects. Subjects that had an increase in pacing thresholds measurements ≤ 1.0V (at 0.5 ms) from pre-MR Scan at MRI Visit to MRI + 1 Month Visit were considered a success.|The time between the MR Scan and MRI + 1 Month|did not include subjects with a MNS between implant and the MRI + 1 Month Visit;failed to meet labeled MRI Conditions of Use, had lead-related complication;had an incomplete scan or no scan; missing lead measurements; missed a visits, subject died or withdrew consent|||percentage of participants with succes||95% Confidence Interval|Number
2561265|NCT02652481|Primary|Percentage of Participants That Had an Increase in Average Pacing Thresholds ≤ 0.5V (Volt) (at 0.5 ms) in the RV|Increases in RV pacing threshold (at 0.5 ms) pre- MR scan and 1 Month post-MR scan were calculated for subjects. Subjects that had an increase in average pacing thresholds ≤ 0.5V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 Month follow-up were considered a success.|The time between the MR Scan and MRI + 1 Month|Did not include subjects that had a MNS between implant and the MRI+1Month Visit; Failed to meet Conditions of Use; Experienced lead-related complication; Had an incomplete scan or no scan, died or withdrew consent, missed a visit, missed lead measurements|||percentage of participants with success||95% Confidence Interval|Number
2561266|NCT02652481|Primary|Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications|MR scan-related CFR (Complication-free rate) between the MR Scan and the MRI + 1 (Magnetic Resonance Imaging) Month Visit|The time between the MR Scan and MRI + 1 Month|All implanted subjects that completed any portion of the study required MR scan and did not have a Medically Necessary Scan (MNS) performed prior to the MRI+1 Month Visit were included in the Primary Safety Endpoint analysis set.|||percentage of participants||97.5% Confidence Interval|Number
2561267|NCT02652468|Secondary|Overall Survival (OS)|OS will be obtained from the KM estimates along with 95% confidence intervals.|Up to 1 year|||||||
2561273|NCT02652468|Primary|Rate of Engraftment, as Defined as Absolute Neutrophil Count >= 500/Mcl for 3 Consecutive Measurements on Different Days and Platelet Count > 20,000/mm^3 With no Platelet Transfusions in the Preceding 7 Days|To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell depletion using HLA haploidentical donors for stem cell transplant in relapsed lymphoma. Will be obtained from the Kaplan-Meier (KM) estimates along with 95% confidence intervals.|At day 28 after transplantation||||Participants|||Count of Participants
2561274|NCT02652416|Secondary|AUC Tau,ss|"This outcome measure presents area under the concentration-time curve of the analyte [BI 1026706] in plasma at steady state over a uniform dosing interval tau (AUC tau,ss).~All subjects in the TS-MD part who provide at least 1 PK parameter in the MD part that was not excluded were to be considered for this endpoint."|23:55, 47:55, 71:55, 95:55, 119:55, 167:55, 239:55, 263:55, 264:15, 264:30, 264:45, 265:00, 265:30, 266:00, 266:30, 267:00, 268:00, 270:00, 272:00, 274:00, 276:00, 288:00, 298:00, 312:00 and 336:00 (hours:minutes) after drug administration.|PKS-MD part.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2561275|NCT02652416|Secondary|Tmax,ss|"This outcome measure presents time from last dosing to maximum concentration of the analyte [BI 1026706] in plasma at steady state (tmax,ss) .~All subjects in the TS-MD part who provide at least 1 PK parameter in the MD part that was not excluded were to be considered for this endpoint."|23:55, 47:55, 71:55, 95:55, 119:55, 167:55, 239:55, 263:55, 264:15, 264:30, 264:45, 265:00, 265:30, 266:00, 266:30, 267:00, 268:00, 270:00, 272:00, 274:00, 276:00, 288:00, 298:00, 312:00 and 336:00 (hours:minutes) after drug administration.|PKS-MD part.|||h||Full Range|Median
2561276|NCT02652416|Secondary|Cmax,ss|"This outcome measure presents maximum measured concentration of the analyte [BI 1026706] in plasma at steady state over a uniform dosing interval tau.~TS-MD part: This subject set included all subjects from the 100 mg group in the SRD part who were dispensed BI 1026706 and were documented to have taken at least 1 dose of investigational treatment in the MD part. All subjects in the TS-MD part who provide at least 1 PK parameter in the MD part that was not excluded were to be considered for this endpoint."|23:55, 47:55, 71:55, 95:55, 119:55, 167:55, 239:55, 263:55, 264:15, 264:30, 264:45, 265:00, 265:30, 266:00, 266:30, 267:00, 268:00, 270:00, 272:00, 274:00, 276:00, 288:00, 298:00, 312:00 and 336:00 (hours:minutes) after drug administration.|PKS-MD part: This set included all evaluable subjects of the TS-MD part who were administered BI 1026706, and provided at least 1 observation for at least 1 PK secondary endpoint without important protocol violations relevant for the evaluation of PK secondary endpoints.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2561277|NCT02652416|Secondary|t1/2|"This outcome measure presents terminal half-life of the analyte [BI 1026706] in plasma.~All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint."|-1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.|PKS-SRD part.|||h||Geometric Coefficient of Variation|Geometric Mean
2561278|NCT02652416|Secondary|AUC0-infinity|"This outcome measure presents area under the concentration-time curve of the analyte [BI 1026706] in plasma over the time interval from 0 extrapolated to infinity.~All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint."|-1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.|PKS-SRD part.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2561279|NCT02652416|Secondary|AUC0-12|"This outcome measure presents area under the concentration-time curve of the analyte [BI 1026706] in plasma over the time interval from 0 extrapolated to 12 hours (AUC0-12).~All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint."|-1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.|PKS-SRD part.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2561280|NCT02652416|Secondary|Tmax|"This outcome measure presents time from dosing to maximum measured concentration of the analyte [BI 1026706] in plasma.~All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint."|-1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.|PKS-SRD part.|||h||Full Range|Median
2561281|NCT02652416|Secondary|Cmax|"This outcome measure presents maximum measured concentration of the analyte [BI 1026706] in plasma.~TS-SRD part: This subject set included all subjects who were dispensed BI 1026706 and were documented to have taken at least 1 dose of investigational treatment in the SRD part. All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint."|-1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.|PharmacoKinetic Set (PKS)–SRD part: This set included all evaluable subjects of the TS-SRD part who were administered BI 1026706, and provided at least 1 observation for at least 1 pharmacokinetic (PK) secondary endpoint without important protocol violations relevant for the evaluation of PK secondary endpoints.|||nanomole (nmol)/Liter (L)||Geometric Coefficient of Variation|Geometric Mean
2561282|NCT02652416|Primary|Percentage of Subjects With Drug-related Adverse Events (AEs)|The percentage of subjects with drug-related AEs indicate the safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects following oral administration of single rising doses of 25 mg, 50 mg, and 100 mg, followed by multiple doses of 100 mg bid.|From first drug administration to 4 days after last drug intake, up to 19 days.|Treated set (TS) : This subject set included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment.|||Percentage of participants|||Number
2561283|NCT02652390|Secondary|Satisfaction Score|Visual analog scale about treatment satisfaction, score 0 (worst) to 100 (best).|5-7 years||||score on a scale||Standard Deviation|Mean
2561284|NCT02652390|Secondary|Bodily Pain Score|Score for the 2-item bodily pain scale, range 0 (worst) to 100 (best).|5-7 years||||score on a scale||Standard Deviation|Mean
2561288|NCT02652390|Primary|Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand|Number of patients who have had carpal tunnel release surgery on the study hand.|5 to 7 years|Data from all trial participants were available with no withdrawals, drop-outs or missing data.|||Participants|||Count of Participants
2561289|NCT02652260|Secondary|Number of Participants Who Discontinued Treatment Due to an AE for the Combined Treatment Groups 24 Weeks After the Switch|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.|24 weeks post-switch|All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed. One participant in the DSG who discontinued from the study, before switching to MK-1439A, was not included in the analysis.|||Participants|||Count of Participants
2561290|NCT02652260|Secondary|Number of Participants With One or More Drug-related SAEs for the Combined Treatment Groups 24 Weeks After the Switch|A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. A drug-related SAE was determined by the investigator to be related to the drug. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.|24 weeks post-switch|All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed. One participant in the DSG who discontinued from the study, before switching to MK-1439A, was not included in the analysis.|||Participants|||Count of Participants
2561291|NCT02652260|Secondary|Number of Participants With One or More SAEs for the Combined Treatment Groups 24 Weeks After the Switch|A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.|24 weeks post-switch|All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed. One participant in the DSG who discontinued from the study, before switching to MK-1439A, was not included in the analysis.|||Participants|||Count of Participants
2561292|NCT02652260|Secondary|Number of Participants With One or More Drug-related AEs for the Combined Treatment Groups 24 Weeks After the Switch|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE was determined by the investigator to be related to the drug. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.|24 weeks post-switch|All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed. One participant in the DSG who discontinued from the study, before switching to MK-1439A, was not included in the analysis.|||Participants|||Count of Participants
2561293|NCT02652260|Secondary|Number of Participants With One or More AEs for the Combined Treatment Groups 24 Weeks After the Switch|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. For the ISG 24 week post-switch was week 24; for the DSG week 24 post-switch was week 36.|24 weeks post-switch|All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed. One participant in the DSG who discontinued from the study, before switching to MK-1439A, was not included in the analysis.|||Participants|||Count of Participants
2561294|NCT02652260|Secondary|Number of Participants Who Discontinued Treatment Due to an AE Through Study Week 12|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to Week 12|All randomized participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2561553|NCT02648646|Secondary|Hand Grip Dynamometry Right Hand|Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.|Month 6||||kilograms||Full Range|Median
2561295|NCT02652260|Secondary|Number of Participants With One or More Drug-related SAEs Through Study Week 12|A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose. A drug-related SAE was determined by the investigator to be related to the drug.|Up to Week 12|All randomized participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2561296|NCT02652260|Secondary|Number of Participants With One or More Serious Adverse Events (SAEs) Through Study Week 12|A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that results in any of the following: death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; is associated with an overdose.|Up to Week 12|All randomized participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2561297|NCT02652260|Secondary|Number of Participants With One or More Drug-related AEs Through Study Week 12|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE was determined by the investigator to be related to the drug.|Up to Week 12|All randomized participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2561298|NCT02652260|Secondary|Number of Participants With One or More Adverse Events (AEs) Through Study Week 12|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to Week 12|All randomized participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2561299|NCT02652260|Secondary|Change From Time of Switch to Week 24 Post Switch in CD4 T-cell Count for the Combined Treatment Groups|Blood was collected at time of switch and at 24 weeks post-switch in order to determine the CD4 T-cell count. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36.|Baseline (time of switch) and 24 weeks post-switch|All randomized participants who received at least one dose of study treatment, and have required CD4 T-cell data. Based on the protocol-specified plan, the combined treatment groups was analyzed.|||cells/mm^3||95% Confidence Interval|Mean
2561300|NCT02652260|Secondary|Percentage of Participants With HIV-1 RNA <50 and <40 Copies/ml at Week 24 Post-switch for the Combined Treatment Groups|Blood was collected under fasting conditions at 24 weeks post-switch in order to determine the HIV-1 RNA. For the ISG week 24 post-switch was week 24. For the DSG week 24 post-switch was week 36.|24 weeks post-switch|All randomized participants who received at least one dose of study treatment, and have required HIV-1 RNA data. Based on the protocol-specified plan, the combined treatment groups was analyzed.|||Percentage of participants||95% Confidence Interval|Number
2561301|NCT02652260|Secondary|Change in Fasting Lipids Between Time of Switch and Week 24 Post-switch for the Combined Treatment Groups|Blood was collected under fasting conditions at time of switch and 24 weeks post-switch in order to determine the change from baseline of the following lipids: low-density lipoprotein (LDL) cholesterol; Non high-density lipoprotein (HDL) cholesterol; cholesterol; HDL cholesterol; and triglyceride. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36.|Baseline (time of switch) and 24 weeks post-switch|All randomized participants who received at least one dose of study treatment, and have required lipid data. Based on the protocol-specified plan, the combined treatment groups was analyzed.|||mg/dL||Standard Deviation|Mean
2561302|NCT02652260|Secondary|Change From Baseline in Fasting Lipids at Week 12|Blood was collected under fasting conditions on Day 1 and on week 12 in order to determine the concentration of the following lipids: low-density lipoprotein (LDL) cholesterol; Non high-density lipoprotein (HDL) cholesterol; cholesterol; HDL cholesterol; and triglyceride.|Baseline (study Day 1) and study week 12|All randomized participants who received at least one dose of study treatment, and have required lipid data.|||mg/dL||Standard Deviation|Mean
2561303|NCT02652260|Secondary|CNS Toxicity Scores at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups|A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A higher CNS score indicates worse symptoms. A positive change in CNS score indicates worsening symptoms. A negative change indicates improvement in symptoms. For the ISG time of switch was study Day 1, and week 24 post-switch was week 24. For the DSG time of switch was study week 12, and week 24 post-switch was week 36.|Baseline (time of switch) and 24 weeks post-switch|All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed.|||Percentage of maximum score||95% Confidence Interval|Mean
2561554|NCT02648646|Secondary|Hand Grip Dynamometry Right Hand|Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.|Week 8||||kilograms||Full Range|Median
2561304|NCT02652260|Secondary|Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Time of Switch, and at 24 Weeks Post-switch for the Combined Treatment Groups|A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. For the Immediate Switch Group (ISG) time of switch was study Day 1, and week 24 post-switch was week 24. For the Delayed Switch Group (DSG) time of switch was study week 12, and week 24 post-switch was week 36.|Baseline (time of switch) and 24 weeks post-switch|All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data. Based on the protocol-specified plan, the combined treatment groups was analyzed.|||Percentage of participants|||Number
2561305|NCT02652260|Secondary|Change From Baseline in CNS Toxicity Score at Week 12|A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A positive change from baseline score indicates worsening symptoms. A negative change from baseline score indicates improvement in symptoms.|Baseline and Week 12|All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data.|||Percentage of maximum score||95% Confidence Interval|Mean
2561306|NCT02652260|Secondary|Change From Baseline in CNS Toxicity Score at Week 4|A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. The CNS toxicity score was calculated by summing across all 10 CNS toxicities and converting the sum to a percentage of the maximum possible sum of intensities (10 x 3 = 30). A positive change from baseline score indicates worsening symptoms. A negative change from baseline score indicates improvement in symptoms.|Baseline and Week 4|All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data.|||Percentage of maximum score||95% Confidence Interval|Mean
2561307|NCT02652260|Secondary|Percentage of Participants With at Least One CNS Toxicity of at Least Grade 2 Intensity at Week 4|A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. Percentage of participants with at least one CNS toxicity of Grade 2 or higher were recorded, based on the last observation carried forward (LOCF) approach.|Week 4|All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data.|||Percentage of participants|||Number
2561308|NCT02652260|Primary|Percentage of Participants With at Least One Central Nervous System (CNS) Toxicity of at Least Grade 2 Intensity at Week 12|A questionnaire was used to solicit for CNS toxicity based on the following 10 events: dizziness; depression/low mood; insomnia/sleeplessness; anxiety/nervousness; confusion; impaired concentration/attention; headache; somnolence/daytime sleepiness; aggressive mood/behavior; and abnormal dreams. Participants were asked to rate the intensity for each of the 10 events as none (Grade 0), mild (Grade 1), moderate (Grade 2), or severe (Grade 3). Mild = symptom is noticeable but does not interfere with normal activities; moderate = symptom has some impact on normal activities; severe = symptom prevents conduct of normal activities. Percentage of participants with at least one CNS toxicity of Grade 2 or higher were recorded, based on the last observation carried forward (LOCF) approach.|Week 12|All randomized participants who received at least one dose of study treatment, and have baseline data for analyses requiring baseline data.|||Percentage of participants|||Number
2561309|NCT02652221|Primary|Agreement in Measured Liver Stiffness Between ARFI and MRE|The investigators are seeking to define agreement between ARFI and MRE liver stiffness measurements obtained in the same patients on the same day to determine if the modalities can be used interchangeably for measurement of liver stiffness and prediction of significant liver fibrosis|Within 24 hours||||Correlation Coefficient (rho)|||Number
2561310|NCT02652221|Primary|Agreement in Measured Liver Stiffness Between ARFI and MRE|The investigators are seeking to define agreement between ARFI and MRE liver stiffness measurements obtained in the same patients on the same day to determine if the modalities can be used interchangeably for measurement of liver stiffness and prediction of significant liver fibrosis|Within 24 hours||||kPa|||Number
2561311|NCT02652208|Secondary|Satisfaction With the Intervention|"Number of respondents who rated the material as very good or excellent."|Within 1 week after reviewing the decision aid|All participants who completed and returned a survey within the 6 month study period.|||Participants|||Count of Participants
2561312|NCT02652208|Secondary|Treatment Leaning (Percentage of Patients Who Have a Clear Treatment Preference)|To determine the percentage of patients who have a clear treatment preference for their stable chest discomfort.|Within 1 week after reviewing the decision aid|Only participants who indicated they currently had symptoms were asked to complete the item|||Participants|||Count of Participants
2561313|NCT02652208|Primary|Total Knowledge Score|Six multiple choice knowledge items covered important facts patients should know about chest pain or discomfort and treatments. A total knowledge score (0-6) was created by summing the total number of correct responses. A missing knowledge response was marked as incorrect. Any survey with more than three missing knowledge responses did not get a total knowledge score. A higher score indicates higher knowledge on the topic. Both decision aids provided information for answering all knowledge items. Higher knowledge scores are better.|Within 1 week after reviewing the decision aid|All participants who completed and returned a survey within the 6 month study period.|||knowledge score||Standard Deviation|Mean
2561314|NCT02652156|Secondary|Number of Days Required for a Patient to Walk Unassisted|Patients will be assessed each day following the day of surgery for the ability to walk unassisted|Assessed daily for up to 3 days post-surgery||||days||Standard Deviation|Mean
2561315|NCT02652156|Secondary|Number of Days Required for a Patient to Get Out of Bed|Patients will be assessed each day following the day of surgery for the ability to get out of bed.|Assessed daily for up to 3 days post-surgery|All 3 patients in the Single Injection of Bupivacaine cohort required 1 day to be able to get out of bed.|||days||Standard Deviation|Mean
2561316|NCT02652156|Secondary|Patient Reported Pain by VAS Scale|Patients will rate their pain by VAS scale 3 days post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.|Postoperative Day 3|Two patients in each of the Single Injection of Bupivacaine and Continuous Infusion of Ropivacaine groups were discharged prior to post-operative day 3. Pain rating data for these subjects were not collected.|||score on a scale||Standard Deviation|Mean
2561317|NCT02652156|Secondary|Patient Reported Pain by VAS Scale|Patients will rate their pain by VAS scale 2 days post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.|Postoperative Day 2||||score on a scale||Standard Deviation|Mean
2561318|NCT02652156|Secondary|Patient Reported Pain by VAS Scale|Patients will rate their pain by VAS scale 1 day post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.|Postoperative Day 1||||score on a scale||Standard Deviation|Mean
2561319|NCT02652156|Secondary|Postoperative Vomiting (Events)|Total number of vomiting episodes over the three postoperative days.|3 postoperative days|No vomiting events were reported by any study subjects.|||Vomiting Events|||Number
2561320|NCT02652156|Primary|Total Dosage of Narcotic|The total use of analgesic medications will be recorded during the 3 days immediately following surgery.|3 postoperative days|1 patient in the Continuous Infusion of Ropivacaine group required no narcotics immediately following surgery (recovery room) due to continuing effect of the blockade. Patients are removed from study upon discharge in later postoperative days.|||Mophine Equivalent Units||Standard Deviation|Mean
2561321|NCT02651922|Secondary|Tolerability Assess Using a 5 Point Scale|Assessment of tolerability using a 5 point scale (very good, good, satisfactory, bad, very bad)|Evaluation of Tolerability on visit 3 (appr. 12 weeks after baseline)||||participants|||Number
2561322|NCT02651922|Secondary|Change of EQ-5D VAS Scores (Pre - Post)|VAS values (Quality of Life) range from 0 (very poor) to 100 (best possible state).|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)||||participants|||Number
2561323|NCT02651922|Secondary|Change in EQ-5D (Health Questionnaire) Scores (Pre - Post)|EQ-5D™ is a standardised instrument for use as a measure of health Outcome The EQ-5D assesses five aspects of QoL: mobility, self-care, usual activity, pain/discomfort and anxiety/depression. An EQ-5D profile score of 0 points represents the worst QoL (death), while 1 point stands for full health. Data analysis was performed according to the EuroQol manual. The EQ-VAS ranges from 0 (worst QoL) to 100 (best QoL).|Change from Baseline (before treatment) to last visit (end of observation- approx. 12 weeks after baseline)||||participants|||Number
2561324|NCT02651922|Secondary|Change of RS-13 (Resilience Questionnaire) (Pre - Post)|RS-13 is a 13 items self Report questionnaire measure the resilience, which applies a reliance scale ranging from 13 (lowest stress resistance) to 91 (highest stress resistance).|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)||||participants|||Number
2561325|NCT02651922|Secondary|Change of BDEPQ (Benzodiazepine Dependence Questionnaire)|"The Benzodiazepine Dependence Questionnaire (BDEPQ) is a 30 item self report questionnaire designed to measure dependence on benzodiazepine tranquilisers, sedatives and hypnotics. Items cover all aspects of the dependence syndrome with the exception of withdrawal symptoms. Each item is rated on a four point likert scale referring to experiences in the last month.~BDEPQ score ranges from 0 (no dependence) to 85 (most severe dependence)."|Change from visit 2 (approx. 4 weeks after baseline) to last visit (end of observation- approx. 12 weeks after baseline)|"For patient with less than 75% items answered the BDEPQ-Score was not calculated.~For only 132 patients Score was calculated."|||participants|||Number
2561326|NCT02651922|Secondary|Change of Symptom Palpation (Pre - Post)|"Symptom was assessed in a Likert scale ranging from 0 no symptoms at all to 10 very severe symptoms"|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 130 patients showed this symptom."|||participants|||Number
2561327|NCT02651922|Secondary|Change of Symptom Trembling (Pre - Post)|"Symptom was assessed in a Likert scale ranging from 0 no symptoms at all to 10 very severe symptoms"|Change from Baseline (before treatment; week 0) to last visit (end of observation - approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 108 patients showed this symptom."|||participants|||Number
2561328|NCT02651922|Secondary|Change of Symptom Nausea (Pre - Post)|"Symptom was assessed in a Likert scale ranging from 0 no symptoms at all to 10 very severe symptoms"|Change from Baseline (before treatment; week 0) to last visit (end of observation-approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 92 patients showed this symptom."|||participants|||Number
2561410|NCT02650895|Secondary|Pharmacokinetics of AUC|Assessment of CD24Fc pharmacokinetics based on plasma CD24Fc concentration at different time points after administration to determine drug area under curve (AUC).|42 days after treatment.|PK Evaluable Population|||ng*hr/mL||Standard Deviation|Mean
2561329|NCT02651922|Secondary|Change of Symptom Transpiration (Pre - Post)|"Symptom was assessed in a Likert scale ranging from 0 no symptoms at all to 10 very severe symptoms"|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline )|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 121 patients showed this symptom."|||participants|||Number
2561330|NCT02651922|Secondary|Change of Symptom Lack of Concentration (Pre - Post)|"Symptom was assessed in a Likert scale ranging from 0 no symptoms at all to 10 very severe symptoms"|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 142 patients showed this symptom."|||participants|||Number
2561331|NCT02651922|Secondary|Change of Symptom Fear (Pre - Post)|"Symptom was assessed in a Likert scale ranging from 0 no symptoms at all to 10 very severe symptoms"|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 133 patients showed this symptom."|||participants|||Number
2561332|NCT02651922|Secondary|Change of Symptom Exhaustion (Pre - Post)|"Symptom was assessed in a Likert scale ranging from 0 no symptoms at all to 10 very severe symptoms"|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 145 patients showed this symptom."|||participants|||Number
2561333|NCT02651922|Secondary|Change of Symptom Sleep Disturbance (Pre - Post)|"Symptom was assessed in a Likert scale ranging from 0 no symptoms at all to 10 very severe symptoms"|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 146 patients showed this symptom."|||participants|||Number
2561334|NCT02651922|Primary|Change of Symptom Inner Restlessness (Pre - Post)|"Symptom was assessed in a Likert scale ranging from 0 no symptoms at all to 10 very severe symptoms"|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 12 weeks after baseline)|"If a symptom was rated 0, it was considered nonexistent. For any other rating (1 to 10) the symptom was considered existent.~Only 146 patients showed this symptom."|||participants|||Number
2561335|NCT02651688|Primary|Change From Baseline in Weight at Week 48|A negative change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||kg||Standard Deviation|Mean
2561336|NCT02651688|Primary|Change From Baseline in Waist Circumference at Week 48|A negative change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||cm||Standard Deviation|Mean
2561337|NCT02651688|Primary|Change From Baseline in Body Mass Index (BMI) at Week 48|BMI is calculated as weight (kg)/height(cm^2). A negative change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||kg/cm^2||Standard Deviation|Mean
2561338|NCT02651688|Primary|Change From Baseline in Blood Quantose-Insulin Resistance (IR) Score at Week 48|Quantose-IR is a laboratory-developed test that assesses insulin resistance. Quantose-IR score is based on a linear regression algorithm utilizing the quantitative measures (natural log transformed) of alpha-hydroxybutyrate, oleate, linoleoylglycerophosphocholine and insulin and was designed to estimate the natural log of insulin-induced glucose infusion rate normalized by whole body mass. The algorithm score is converted to the Quantose-IR score within a range of 1-120 by an arithmetic calculation where higher scores denote greater insulin resistance. A negative change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||Quantose-IR score||Standard Deviation|Mean
2561339|NCT02651688|Primary|Change From Baseline in Homeostatic Model of Assessment - Insulin Resistance (HOMA-IR) at Week 48|The HOMA-IR is the product of the blood Glucose and Insulin levels, divided by a constant. HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/mL) × fasting plasma glucose (mmol/L)/22.5. A negative change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||units on a scale||Standard Deviation|Mean
2561340|NCT02651688|Primary|Change From Baseline in Blood Leptin Level at Week 48|A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter leptin. A negative change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||ng/mL||Standard Deviation|Mean
2561341|NCT02651688|Primary|Change From Baseline in Blood Tumor Necrosis Factor Alpha (TNF-α) Level at Week 48|A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter TNF-α . A negative change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||pg/mL||Standard Deviation|Mean
2561342|NCT02651688|Primary|Change From Baseline in Blood Interleukin-6 (IL-6) Level at Week 48|A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter IL-6. A negative change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||pg/mL||Standard Deviation|Mean
2561343|NCT02651688|Primary|Change From Baseline in Blood C-reactive Protein (CRP) Level at Week 48|A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter CRP. A negative change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||mg/dL||Standard Deviation|Mean
2561344|NCT02651688|Primary|Change From Baseline in Blood Glucose Level at Week 48|A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter Glucose. A negative change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||pg/mL||Standard Deviation|Mean
2561345|NCT02651688|Primary|Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 48|A blood sample was collected at Baseline and Week 48 for the assessment of the metabolic parameter HbA1c. A negative change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||percentage of HbA1c||Standard Deviation|Mean
2561346|NCT02651688|Primary|Change From Baseline in Ratio of Dihydrotestosterone: Testosterone (DHT:T) at Week 48|The DHT:T ratio was calculated as the value of DHT/value of T using the same units. A negative change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||ratio||Standard Deviation|Mean
2561347|NCT02651688|Primary|Change From Baseline in Ratio of Testosterone: Estradiol (T:E2) at Week 48|The T:E2 ratio was calculated as the value of T/value of E2 using the same units. A positive change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||ratio||Standard Deviation|Mean
2561348|NCT02651688|Primary|Change From Baseline in Blood Estradiol (E2) Level at Week 48|A blood sample was collected at Baseline and Week 48 for the assessment of the hormone parameter E2. A positive change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||pg/mL||Standard Deviation|Mean
2561349|NCT02651688|Primary|Change From Baseline in Blood Dihydrotestosterone (DHT) Level at Week 48|A blood sample was collected at Baseline and Week 48 for the assessment of the hormone parameter DHT. A positive change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||nanogram per deciliter (ng/dL)||Standard Deviation|Mean
2561350|NCT02651688|Primary|Change From Baseline in Blood Testosterone (T) Level at Week 48|A blood sample was collected at Baseline and Week 48 for the assessment of the hormone parameter T. A positive change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||ng/dL||Standard Deviation|Mean
2561351|NCT02651688|Primary|Change From Baseline in Blood Luteinizing Hormone (LH) Level at Week 48|A blood sample was collected at Baseline and Week 48 for the assessment of the hormone parameter LH measured in milli-International Units per milliliter (mIU/mL). A positive change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||mIU/mL||Standard Deviation|Mean
2561352|NCT02651688|Primary|Change From Baseline in Body Strength (Leg Press Weight) at Week 48|Body strength was assessed from maximum chest and leg press weight achieved, using an inclined plane leg press and vertical chest press. A positive change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||pounds (lbs)||Standard Deviation|Mean
2561353|NCT02651688|Primary|Change From Baseline in Body Strength (Chest Press Weight) at Week 48|Body strength was assessed from maximum chest and leg press weight achieved, using an inclined plane leg press and vertical chest press. A positive change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|ITT population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||pounds (lbs)||Standard Deviation|Mean
2561354|NCT02651688|Primary|Change From Baseline in Lean Body Mass (LBM) at Week 48|LBM was assessed using dual-energy X-ray absorptiometry (DXA). A positive change from Baseline indicates improvement.|Baseline (Day 0) to Week 48|Intent to treat (ITT) population consisted of all participants randomized to treatment with enclomiphene or placebo. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||kg||Standard Deviation|Mean
2561355|NCT02651584|Secondary|Number of Subjects Remaining in the Study (Retention Rate)|Number of Subjects Remaining in the Study (Retention Rate) on SL BPN/NX and CAM2038|24 weeks||||Participants|||Count of Participants
2561356|NCT02651584|Secondary|Number of Subjects With Sustained Abstinence of Opioid Use|Number of Subjects with Sustained Abstinence of Opioid Use taking SL BPN/NX and CAM2038|24 weeks||||Participants|||Count of Participants
2561357|NCT02651584|Secondary|Cumulative Distribution Function (CDF) of Percentage of Urine Samples Negative for Illicit Opioids|Cumulative distribution function (CDF) of percentage of urine samples negative for illicit opioids comparing CAM2038 to SL BPN/NX as (supported by self-reported opioid use results)|24 weeks|Includes all subjects who were randomized and receiving at least one dose of study drug.|||percentage of negative urine samples||Full Range|Median
2562632|NCT02636049|Secondary|Incidence of Treatment Emergent Adverse Events|The number of patients that experienced treatment emergent adverse events will be quantified.|10 - 14 days|Safety Population: all enrolled subjects|||participants|||Number
2561358|NCT02651584|Primary|Response Rate, Denoted by Response Rate (Weeks 1-24).|Response Rate, denoted by response rate (Weeks 1-24). A responder is defined as a subject with at least 33% of urine toxicology results collected during the Phase 1 (4 out of 12 urine samples) and 67% of urine toxicology results collected during Phase 2 (4 out of 6 urine samples) being negative for illicit opioids and self - reported illicit opioid use.|24 weeks|Includes all subjects who were randomized and receiving at least one dose of study drug.|||Participants|||Count of Participants
2561359|NCT02651467|Secondary|Change From Baseline in Visual Rating Scale (VRS) at Week 4 and 8|"Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The subjects were asked to rate their pain on a scale of 1 (No Pain) to 10 (Intense Pain)."|Baseline, Week 4 and 8|"Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.~Note: Baseline population only includes those subjects who have a corresponding post-baseline assessment."|||Score on a scale||Standard Deviation|Mean
2561360|NCT02651467|Secondary|Change From Baseline in Tactile Threshold at Week 4 and 8|Pressure was administered using a constant pressure probe (Yeaple Probe). The constant pressure probe allows the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant reporting pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The greater the tactile threshold, the less sensitive the tooth.|Baseline, Week 4 and 8|"Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.~Note: Baseline population only includes those subjects who have a corresponding post-baseline assessment."|||grams||Standard Deviation|Mean
2561361|NCT02651467|Secondary|Change From Baseline in Schiff Sensitivity Score at Week 4|Schiff sensitivity score was assessed as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, using scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of syimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3=Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.|Baseline and Week 4|Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||Score on scale||Standard Deviation|Mean
2561362|NCT02651467|Secondary|Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 vs. Treatment 2)|Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.|Baseline and Week 8|Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. Data shown for Treatment 1& 2 only for this endpoint. Baseline data only includes those participants who have a corresponding post-baseline assessment.|||Score on a scale||Standard Deviation|Mean
2561363|NCT02651467|Primary|Change From Baseline in Schiff Sensitivity Score at Week 8 (Treatment 1 and 2 Versus [vs.] Placebo)|Schiff sensitivity score was assessed by participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth, response of participant was scored using Schiff sensitivity scale range of 0-3; 0=Participant does not respond to air stimulation; 1=Participant responds to air stimulus but does not request discontinuation of stimulus; 2=Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.|Baseline and Week 8|Intent-to-treat (ITT) population (N=218), defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. This analysis was conducted on ITT population. Baseline data only includes those participants who have a corresponding post-baseline assessment.|||Score on scale||Standard Deviation|Mean
2561364|NCT02651415|Secondary|Median Time to Progression Free Survival (PFS)|Median time (in months) to PFS. PFS is defined as the time from start date of study drugs to the date of first documented disease progression (radiological or clinical) or death due to any cause, if death occurs before progression is documented. PFS will be evaluated based on RECIST v1.1 criteria, 20% progression or any new lesion.|From start date of study drugs to the date of first documented disease progression or death due to any cause.||||Months||95% Confidence Interval|Median
2561365|NCT02651415|Secondary|Median Time Course to Development of Worst Grade (Grade 3) HFSR as Assessed by CTCAE v4.03 Criteria When Treated With a Combination of Regorafenib and Perindopril|Median time course for participants to develop worst grade 3 HFSR toxicity is defined as the time (days) from start date of study drug to date of first documented grade 3 HFSR toxicity and will be calculated only for patients who had a HFSR toxicity grade 3.|p to Safety Follow-Up Visit (30 days +/- 7 days after permanently stopping study treatment)||||days||Full Range|Median
2561366|NCT02651415|Secondary|Number of Participants With Maximal Severity of HFSR as Assessed by CTCAE v4.03 Criteria When Treated With a Combination of Regorafenib and Perindopril|The number of participants that experienced an HFSR of grade 3 or above as assessed by CTCAE v4.03 criteria when treated with a combination of regorafenib and perindopril.|Up to Safety Follow-Up Visit (30 days +/- 7 days after permanently stopping study treatment)||||Participants|||Count of Participants
2561367|NCT02651415|Secondary|The Number of Participants That Experienced All Grade Toxicities as Assessed by CTCAE v4.03 Criteria When Treated With a Combination of Regorafenib and Perindopril|All grades of adverse events (including HFSR) will be evaluated using CTCAE v4.03, at baseline and at D1 of each cycle while they are on the study drug and during the 30-day follow-up period (Post therapy).|At baseline and at D1 of each cycle while on the study drug and during the 30-day follow-up period||||participants|||Number
2561368|NCT02651415|Secondary|The Number of Participants That Experienced Any Grade of Hypertension as Assessed by CTCAE v4.03 Criteria When Treated With a Combination of Regorafenib and Perindopril|All grades of hypertension will be evaluated using CTCAE v4.03, weekly for the first six weeks while they are on the study drug, then every second week and during the 30-day follow-up period (Post therapy).|Weekly for the first six weeks while on the study drug, then every second week and during the 30-day follow-up period||||Participants|||Count of Participants
2561369|NCT02651415|Primary|Number of Participants That Have Any Grade HFSR Toxicity|"The trial will measure the toxicities of HFSR in participants receiving both perindopril and regorafenib using the CTCAE v4.03 criteria.~The toxicity of HFSR will be expressed based on the number of participants in the study (N=10) who are experiencing HFSR of all grades."|Up to Safety Follow-Up Visit (30 days +/- 7 days after permanently stopping study treatment)||||Participants|||Count of Participants
2561370|NCT02651194|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
2561371|NCT02651194|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|up to 12 weeks|All participants who received at least 1 dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
2561372|NCT02651194|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug|12 weeks after the last actual dose of study drug|Intent-to-treat population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2561373|NCT02651155|Secondary|Weekly Abdominal Symptoms Score|The abdominal symptoms (bloating and discomfort upon waking in the morning) were scored weekly on a 5-point scale, where: 0=None, 1=Mild, 2=Moderate, 3=Severe or 4=Very severe, with a higher score indicating more severe symptoms. Assessment of weekly abdominal symptoms were recorded by the participant in the diary.|Weeks 1, 2, 3 and 4|FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method.|||scores on a sclae||Standard Deviation|Mean
2561374|NCT02651155|Secondary|Mean Degree Stool Consistency Score|For each participant, the mean stool consistency score was averaged for all SBMs in a given week. The mean degree of stool consistency for each SBM was collected in the participant diary based on the Bristol Stool Chart. The Bristol Stool Chart is a visual medical aid designed to classify the form of human feces into seven categories where: 1=Hard and round (difficult-to-pass), 2=Sausage-shaped but hard stool, 3=Sausage-shaped stool with cracks on the surface, 4=Sausage-shaped, soft stool with smooth surface, or coiled stool, 5=Soft, half-solid (and easy-to-pass) stool with clear crease, 6=Unshaped, loose stool with small, irregular-shaped pieces, or mushy stool or 7=Watery stool without solid pieces (entirely liquid).|Weeks 1, 2, 3 and 4|FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method.|||scores on a scale||Standard Deviation|Mean
2561375|NCT02651155|Secondary|Mean Degree of Straining Score|For each participant, the mean degree of straining was averaged for all SBMs in a given week. The degree of straining for each SBM was collected in the participant diary. The degree of straining is scored on a 5-point scale where: 0=No straining, 1=Mild straining, 2=Moderate straining, 3=Strong straining or 4=Very strong straining with higher scores indicating more severe straining.|Weeks 1, 2, 3 and 4|FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method.|||scores on a scale||Standard Deviation|Mean
2561376|NCT02651155|Secondary|Percentage of Participants Who Had a SBM Within 24 Hours After the First Dose of Study Medication|A SBM is defined as any BM that does not occur within 24 hours after rescue medication use. Percentage of participants who had a SBM within 24 hours after the first dose was assessed and derived from the data on SBMs collected in the participant diary.|Up to 24 hours after the first dose of study medication|FAS included all participants who were randomized to receive study treatment whether or not they received treatment.|||percentage of participants|||Number
2561377|NCT02651155|Secondary|SBM Frequency at Weeks 2, 3 and 4|A SBM is defined as any BM that does not occur within 24 hours after rescue medication use. SBM frequency data was collected in a diary. Participants were given a diary to complete at home where they recorded the date and time of each BM.|Weeks 2, 3 and 4|FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by LOCF method.|||SBMs/week||Standard Deviation|Mean
2561378|NCT02651155|Primary|Spontaneous Bowel Movement (SBM) Frequency at Week 1|A SBM is defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). SBM frequency data was collected in a diary. Participants were given a diary to complete at home where they recorded the date and time of each BM.|Week 1|FAS included all participants who were randomized to receive study treatment whether or not they received treatment. Missing values were imputed by last observation carried forward (LOCF) method.|||SBMs/week||Standard Deviation|Mean
2561379|NCT02651103|Primary|Change in Cerebral Oxygenation Values Throughout the Procedure|Measured on the NIRS cerebral oxygenation monitor attached to the patient|prior to induction of anesthesia in the awake patient and following four ventilation strategies (average time frame of 15 mins. to 5 hours)||||rSO2||Standard Deviation|Mean
2561380|NCT02650921|Secondary|Question 13 From Subject Satisfaction Questionnaire|Question 13: I would have another treatment to maintain these results|Week 12|ITT|||Participants|||Count of Participants
2561381|NCT02650921|Secondary|Question 12 From Subject Satisfaction Questionnaire|Question 12: I would recommend this treatment to a friend|Week 12|ITT|||Participants|||Count of Participants
2561411|NCT02650895|Secondary|Pharmacokinetics of Drug Cmax.|Assessment of CD24Fc pharmacokinetics based on plasma CD24Fc concentration at different time points after administration to determine drug Cmax.|42 days after treatment.|PK Evaluable Population|||ng/mL||Standard Deviation|Mean
2561412|NCT02650895|Secondary|Pharmacokinetics of Drug.|Measurement of plasma CD24Fc concentration at different time points after administration.|42 days after treatment|Pharmacokinetics of CD24Fc|||ng/ml||Standard Deviation|Mean
2561413|NCT02650895|Primary|Assessment of Safety Based Primarily on the Frequency and Nature of Adverse Events, Clinical Laboratory Assessments (Chemistry, Hematology, and Urinalysis), Physical Examinations, Vital Signs, 12-lead ECGs, and Telemetry Monitoring.|List of adverse events in the form of frequency and grade. Assessment of safety based primarily on the frequency and nature of adverse events, clinical laboratory assessments (chemistry, hematology, and urinalysis), physical examinations, vital signs, 12-lead ECGs, and telemetry monitoring from pre-dosing to day 42 visits.|42 days after treatment|Drug-related Treatment-Emergent Adverse Events by System Organ Class and Preferred Term in Intent-to-Treat Population.|||Participants|||Count of Participants
2561414|NCT02650856|Secondary|Therapeutic Effect on Drainage Quantification|The blood quantification will be taken at 6am every day.|up to 2nd day post operative (24 and 48 hrs)||||mL||Standard Deviation|Mean
2561415|NCT02650856|Secondary|Therapeutic Effect on Hematocrit Level|The blood test will be taken at 6am every day. Using the same laboratory parameters.|up to 3rd day post operative (Baseline, 24, 48 and 72hrs)||||percentage of Hematocrite||Standard Deviation|Mean
2561416|NCT02650856|Primary|Therapeutic Effect on Hemoglobin Level|The blood test will be taken at 6am every day. Using the same laboratory parameters.|up to 3rd day post operative (Baseline, 24, 48 and 72hrs)||||g/dL||Standard Deviation|Mean
2561417|NCT02650466|Secondary|Total Number of Serious Adverse Events That Occur During the Course of the Study|Number of participants, regardless of whether they completed the study, who experience serious adverse events will be aggregated through study completion from the clinical report forms and reported at the end of the study.|an average of 140 days||||Participants|||Count of Participants
2561418|NCT02650466|Secondary|Total Number of Adverse Events That Occur During the Course of the Study|Number of participants who experience an adverse event, regardless of whether they completed the study, will be aggregated through study completion. Both anticipated and unanticipated adverse events will be reported.|an average of 140 days|During initial treatment of a wart on a digit, mild pain radiated up the finger from the wart at time of treatment. The pain persisted for 30min. P.O. Tylenol was provided at the time treatment. This did not re-occur during treatments 2,3 and 4.|||participants|# of warts treated||Number
2561419|NCT02650466|Primary|Clinical Clearance of Warts|Response rate is defined in each case in terms of no effect (NE=2), partial response (PR=1), or complete response (CR=0). No Effect (NE) would indicate no clinically apparent reduction in lesion size, Partial Response (PR) would indicate a reduction in lesion size, and Complete Response (CR) would indicate no evidence of the lesion detected.|168 days after first treatment application|The total number of participants who completed the study equals 17. But because one participant had 3 warts that received treated with differing results, they are counted twice (for that participant, one wart cleared and two showed no effect).|||# of warts|# of warts treated||Number
2561420|NCT02650440|Secondary|Berg Scale|Berg Scale is a functional scale of equilibrium performance, based on 14 common everyday items that evaluate the static and dynamic balance. The maximum scale score is 56 and each scale item has five alternatives ranging from 0 to 4 points. A score below 45 is considered a fall risk. This study comparede the change in the balance control applied scale after intervention as compared to baseline.|Baseline and 6 weeks||||units on a scale||Standard Error|Mean
2561421|NCT02650440|Secondary|Lower Limbs Fugl-Meyer|"The Fugl Meyer Scale is a cumulative numerical scoring system that is assessed by an individual: range of motion, pain, tenderness, upper and lower extremity motor function and balance, plus coordination and speed of movement, with total 226 points. A three-point ordinal scale is applied to each item: 0 - can not be performed, 1-performed partially and 2-performed completely. For this study it was only an evaluation of motor function of the extremity of lower limbs with a total score of 0 to 34 points. The lower score indicates greater motor impairment.~This study compared the change in motor function of lower limbs applied scale after intervention as compared to baseline"|Baseline and 6 weeks||||units on a scale||Standard Error|Mean
2561422|NCT02650440|Secondary|Ten-meters Walking Test (10MWT)|Change in the time of the gait applied test after intervention as compared to baseline|Baseline and 6 weeks||||seconds||Standard Error|Mean
2561423|NCT02650440|Secondary|Time Up and Go (TUG)|This test assesses the level of mobility of the individual to measure the time spent to get up from a chair, walk a distance of 3 meters, turn around and return. This study compared the change in the time of the gait applied test after intervention as compared to baseline.|Baseline and 6 weeks||||seconds||Standard Error|Mean
2561424|NCT02650440|Secondary|Six-minute Walking Test (6MWT)|Change in distance of the gait applied test after intervention as compared to baseline|Baseline and 6 weeks||||meters||Standard Error|Mean
2561425|NCT02650440|Primary|Functional Ambulation Scale (FAC)|"The Functional Ambulation Scale (FAC) assesses an individual's independence during gait and follows a six-level scale: 0 - Patient can not walk or ask for help from two or more people; 1 - Patient requires continuous support from a person who assists with weight and balance; 2 - Patient needs continuous or intermittent support from a person to help with balance and coordination; 3 - Patient required for a person without physical contact; 4 - Patient can walk independently on the floor, but requires help on stairs and ramps; 5 - Patient can walk independently.~This study compared the gait independence by the FAC between the two Arms, after intervention as compared to baseline."|Baseline and 6 weeks||||units on a scale||Inter-Quartile Range|Median
2561426|NCT02650219|Secondary|Number of Patients With : Antinuclear and/or Anti-SSa and/or Anti-SSb and/or Anti-RNP and/or Anti-DNA and/or Anti-Sm and/or Anticardiolipid and/or Anti β2Gp1 and/or Antiganglioside Autoantibodies (Genetics Analyses From Blood Samples)|data available from biological analyses (blood samples)|baseline|antinuclear autoantibodies|||participants|||Number
2561427|NCT02650219|Secondary|Number of Patients With : Photosensitivity and/or Raynaud Phenomenon and/or Sicca Syndrome and/or Arthralgia and/or Arthritis and/or Thrombosis (Medical History and Questionnaire)|Features usually associated with auto immune disease- data available from medical record of the patients|Baseline|||||||
2561428|NCT02650219|Secondary|Number of Patients With : Splenectomy and/or Bone Events and/or Pulmonary Hypertension and/or Specific Treatment and Non-specific (Medical History,Physiological Parameters and Questionnaire)|data available from medical record of the patients|Baseline|splenectomy testing|||participants|||Number
2561429|NCT02650219|Primary|Number of Patients With GD Diagnosis Confirmed by : Enzyme Testing of acidβ-glucosidase Activity Activity <15% in Blood Leucocytes Completed When Necsssary by GB1 Mutation Analyses (Analyses From Samples)|"acidβ-glucosidase enzyme testing : a lower than 15% of mean normal activity is considered to be diagnostic.~Decreased enzyme levels will often be confirmed by genetic testing. Numerous different mutations occur; GB1 mutation analyses is sometimes necessary to confirm the diagnosis."|baseline||||participant|||Number
2561430|NCT02650193|Other Pre-specified|Number of Participants With Positive Anti-pegfilgrastim (Anti-drug) Antibodies||Baseline up to approximately Day 94|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2561431|NCT02650193|Other Pre-specified|Duration of Exposure to Study Drug Medication||Baseline up to approximately Day 94|Safety analysis set included all participants who received at least 1 dose of study medication.|||days||Full Range|Median
2561432|NCT02650193|Other Pre-specified|Number of Participants With At Least 1 Concomitant Medication||Baseline up to approximately Day 94|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2561433|NCT02650193|Other Pre-specified|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities|Clinically significant abnormality was based upon investigator's discretion.|Baseline up to approximately Day 94|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2561434|NCT02650193|Other Pre-specified|Number of Participants With Clinically Significant Physical Examination Abnormalities|Physical examination included physical assessment of the spleen. Clinically significant abnormality was based on investigator's discretion.|Baseline up to approximately Day 94|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2561435|NCT02650193|Other Pre-specified|Number of Participants With Clinically Significant Vital Sign Abnormalities|Vital sign assessment included body temperature (tympanic or axillary), heart rate (sitting), blood pressure (sitting systolic and diastolic), and respiratory rate. Clinically significant abnormality was based upon investigator's discretion.|Baseline up to approximately Day 94|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2561436|NCT02650193|Other Pre-specified|Number of Participants With Laboratory Abnormalities|Criteria: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, neutrophils); chemistry (alkaline phosphatase, glucose, lactate dehydrogenase, alanine aminotransferase, aspartate aminotransferase, albumin, creatinine and gamma-glutamyl transpeptidase, blood urea nitrogen, total protein, phosphate, and uric acid); urinalysis. The clinical laboratory results and patterns observed were consistent with the known therapeutic response and the safety profile for the US and EU approved pegylated filgrastim (Neulasta).|Baseline up to approximately Day 94|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2561437|NCT02650193|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) of Special Interest|AEs of Special Interest (AESI) included Potential Allergic Reactions, Splenomegaly, Splenic Rupture, Acute Respiratory Distress Syndrome, Alveolar Hemorrhage, Hemoptysis, Leukocytosis, Thrombocytopenia, Capillary Leak Syndrome, Cytokine Release Syndrome, Cutaneous Vasculitis and Glomerulonephritis.|Baseline up to approximately Day 94|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2561438|NCT02650193|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment Emergent Adverse Event (TEAE) was adverse event that started or worsened in severity after the HSP-130 administration up to and including 30 days post HSP-130 administration (up to Day 94). AEs included both serious and non-serious.|Baseline up to approximately Day 94|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2561439|NCT02650193|Secondary|Protein-Content Corrected Maximum Observed Serum Concentration (Cmax): Cycle 1 and Cycle 4|The protein-content correction was conducted for Cmax parameter: Protein-content corrected Cmax = Nominal Protein-content Cmax / (Actual protein concentration/10.0 mg/mL).|Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication.|||pg/mL||Standard Deviation|Mean
2561440|NCT02650193|Secondary|Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 1 and Cycle 4|The protein-content correction was conducted for AUCinf parameter: Protein-content corrected AUCinf = Nominal Protein-content AUCinf / (Actual protein concentration/10.0 mg/mL).|Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. Here 'number analyzed' signifies number of participants evaluable at the specified timepoints only.|||h*pg/mL||Standard Deviation|Mean
2561441|NCT02650193|Secondary|Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 1 and Cycle 4|The protein-content correction was conducted for AUCt parameter: Protein-content corrected AUCt= Nominal Protein-content AUCt / (Actual protein concentration/10.0 mg/mL).|Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication.|||h*pg/mL||Standard Deviation|Mean
2561741|NCT02646891|Secondary|Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen|Measured at Baseline and 28 days after the final injection (Day 84 for adults; Day 28 for toddlers).|Baseline and Day 28 for toddlers or Day 84 for adults|Per protocol population; participants with valid specimens at each time point.|||titer||95% Confidence Interval|Geometric Mean
2561442|NCT02650193|Secondary|Apparent Clearance (CL/F): Cycle 1 and Cycle 4|CL/F was defined as a quantitative measure of the rate at which a drug substance is removed from the body.|Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. Here 'number analyzed' signifies number of participants evaluable for this outcome measure at specified time points.|||mL/h||Standard Deviation|Mean
2561443|NCT02650193|Secondary|Elimination Rate Constant (λz): Cycle 1 and Cycle 4|Elimination rate constant was defined as the rate at which the drug was removed from the body.|Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. Here, 'number analyzed' signifies number of participants evaluable for this outcome measure at specified time points.|||per hour||Standard Deviation|Mean
2561444|NCT02650193|Secondary|Elimination Half-Life (t1/2): Cycle 1 and Cycle 4|t1/2 is the time taken for plasma concentration of a drug to reduce by 50% of its initial value.|Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. Here 'number analyzed' signifies number of participants evaluable for this outcome measure at specified time points.|||hour||Standard Deviation|Mean
2561445|NCT02650193|Secondary|Time To Achieve Maximum Serum Concentration (Tmax): Cycle 1 and Cycle 4||Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication.|||hour||Full Range|Median
2561446|NCT02650193|Secondary|Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 1 and Cycle 4|AUC0-inf = Area under the serum concentration versus time curve (AUC) from the time of dose administration to extrapolated infinite time (0-inf).|Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. Here, 'number analyzed' field signifies that the number of participants were evaluable at specified time point.|||h*pg/mL||Standard Deviation|Mean
2561447|NCT02650193|Secondary|Time to ANC Recovery: Cycle 1 and Cycle 4|Time to ANC recovery was defined as the time from documentation of the first day with ANC greater than equal to (>=) 2.0 x10^9/L after any day with ANC <2.0 x10^9/L.|Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.|||days||Standard Deviation|Mean
2561448|NCT02650193|Secondary|Incidence of Severe Neutropenia: Cycle 1 and Cycle 4|Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was < 0.5 x10^9/L.|Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.|||participants|||Number
2561449|NCT02650193|Secondary|Incidence of Febrile Neutropenia: Cycle 1 and Cycle 4|Febrile Neutropenia was defined as tympanic or axillary body temperature greater than (>) 38.5 °C for >1 hour and ANC less than (<) 1.0 *10^9/L.|Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.|||participants|||Number
2561450|NCT02650193|Secondary|Area Under the Effect Curve for Absolute Neutrophil Count From Time of Dose Administration to Time Infinity (AUEC_ANC Inf): Cycle 1 and Cycle 4|Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.|Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. Here, “number analyzed” field signifies that the number of participants were evaluable at specified time point.|||hour*10^9 Neutrophils per Liter||Standard Deviation|Mean
2561451|NCT02650193|Secondary|Area Under the Effect Curve (AUEC_ANCt): Cycle 1 and Cycle 4|ANC is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.|Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.|||hour*10^9 Neutrophils per Liter||Standard Deviation|Mean
2561452|NCT02650193|Secondary|Time of ANC Nadir Concentration: Cycle 1 and Cycle 4|Time of ANC Nadir (in hours) was defined as the time from the first dose of study treatment on Day 2 of Cycle 1 and 4 to the time the lowest value was recorded.|Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.|||hour||Standard Deviation|Mean
2561453|NCT02650193|Secondary|Absolute Neutrophil Count Nadir Concentration: Cycle 1 and Cycle 4|Nadir was defined as the lowest count for ANC concentration reported after first dose of study treatment.|Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms.|||*10^9 Neutrophils per Liter||Standard Deviation|Mean
2561454|NCT02650193|Secondary|Duration of Severe Neutropenia (DSN): Cycle 4|Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was < 0.5 x10^9/L. DSN was defined as the days with grade 4 neutropenia (ANC < 0.5 x10^9/L).|Cycle 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose|"FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms. Here, 'Overall number of participants analyzed signifies number of participants evaluable for the specified outcome measure."|||days||Standard Deviation|Mean
2561455|NCT02650193|Secondary|Protein-Content Corrected Maximum Observed Serum Concentration (Cmax): Cycle 0|The protein-content correction was conducted for Cmax parameter: Protein-content corrected Cmax = Nominal Protein-content Cmax / (Actual protein concentration/10.0 mg/mL).|Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication.|||pg/mL||Standard Deviation|Mean
2561456|NCT02650193|Secondary|Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 0|The protein-content correction was conducted for AUCt parameter: Protein-content corrected AUCt= Nominal Protein-content AUCt / (Actual protein concentration/10.0 mg/mL).|Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication.|||h*pg/mL||Standard Deviation|Mean
2561457|NCT02650193|Secondary|Protein-Content Corrected Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 0|The protein-content correction was conducted for AUCinf parameter: Protein-content corrected AUCinf = Nominal Protein-content AUCinf / (Actual protein concentration/10.0 mg/mL).|Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication.|||h*pg/mL||Standard Deviation|Mean
2561458|NCT02650193|Secondary|Apparent Clearance (CL/F): Cycle 0|Clearance of a drug was defined as the rate at which a drug was metabolized or eliminated by normal biological processes.|Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication.|||milliliter per hour (mL/h)||Standard Deviation|Mean
2561459|NCT02650193|Secondary|Elimination Rate Constant (λz): Cycle 0|Elimination rate constant was defined as the rate at which the drug was removed from the body.|Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication.|||per hour||Standard Deviation|Mean
2561460|NCT02650193|Secondary|Elimination Half-Life (t1/2): Cycle 0|t1/2 is the time taken for plasma concentration of HSP 130 to reduce by 50 percent (%) of its initial value.|Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication.|||hour||Standard Deviation|Mean
2561461|NCT02650193|Secondary|Time To Achieve Maximum Serum Concentration (Tmax): Cycle 0||Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication.|||hour||Full Range|Median
2561462|NCT02650193|Secondary|Area Under the Serum Concentration Time Curve From the Time of Dose Administration to the Time of Last Measurable Concentration (AUCt): Cycle 0|AUC0-t= Area under the serum concentration of HSP-130 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).|Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication.|||h*pg/mL||Standard Deviation|Mean
2561463|NCT02650193|Secondary|Area Under the Effect Curve From Time of Dose Administration to Time Infinity for CD34 + (AUEC_CD34+ Inf): Cycle 0||Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose|"FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm. Here Overall number of participants analyzed signifies number of participants evaluable for the specified outcome measure."|||hour*cells per microliter (h*cells/mcL)||Standard Deviation|Mean
2561464|NCT02650193|Secondary|Area Under the Effect Curve for Absolute Neutrophil Count From Time of Dose Administration to Time Infinity (AUEC_ANC Inf): Cycle 0|ANC is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.|Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure.|||hour*10^9 Neutrophils per Liter||Standard Deviation|Mean
2561465|NCT02650193|Secondary|Time of Maximum Effect for CD34+ Count (CD34+ Tmax): Cycle 0||Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.|||hour||Full Range|Median
2561466|NCT02650193|Secondary|Maximum Effect for CD34+ Count (CD34+_Emax): Cycle 0||Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.|||cells per microliter (cells/mcL)||Standard Deviation|Mean
2561467|NCT02650193|Secondary|Area Under the Effect Curve for CD34+ (AUECCD34+): Cycle 0||Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.|||hour*cells per microliter (h*cells/ mcL)||Standard Deviation|Mean
2561468|NCT02650193|Secondary|Time of Maximum Effect for Absolute Neutrophil Count (ANC_Tmax): Cycle 0|ANC was a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.|Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.|||hour||Full Range|Median
2561469|NCT02650193|Secondary|Maximum Effect for Absolute Neutrophil Count (ANC_Emax): Cycle 0|ANC was a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.|Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.|||*10^9 Neutrophils per Liter||Standard Deviation|Mean
2561470|NCT02650193|Primary|Maximum Observed Serum Concentration (Cmax): Cycle 1 and Cycle 4||Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication.|||pg/mL||Standard Deviation|Mean
2561471|NCT02650193|Primary|Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time of Last Measurable Concentration (AUCt): Cycle 1 and Cycle 4|AUC0-t= Area under the serum concentration of HSP-130 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).|Cycle 1 and 4: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication.|||h*pg/mL||Standard Deviation|Mean
2561472|NCT02650193|Primary|Duration of Severe Neutropenia (DSN): Cycle 1|Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was < 0.5 x10^9 per liter. DSN was defined as the days with grade 4 neutropenia (ANC < 0.5 x10^9/L).|Cycle 1: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycle 0: HSP-130 3mg and Cycle 0: HSP-130 6mg arms. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure.|||days||Standard Deviation|Mean
2561473|NCT02650193|Primary|Maximum Observed Serum Concentration (Cmax): Cycle 0||Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication.|||picogram per milliliter (pg/mL)||Standard Deviation|Mean
2561474|NCT02650193|Primary|Area Under the Serum Concentration Time Curve From Time of Dose Administration to Time Infinity (AUCinf): Cycle 0|AUCinf = Area under the serum concentration of HSP-130 versus time curve (AUC) from the time of dose administration to extrapolated infinite time (0-inf).|Cycle 0: Predose (0 hour), 6, 12, 24, 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication.|||hour*picogram per milliliter (h*pg/mL)||Standard Deviation|Mean
2561475|NCT02650193|Primary|Area Under the Effect Curve for Absolute Neutrophil Count (AUECANC): Cycle 0|Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.|Cycle 0: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose|FAS included all participants who received at least 1 dose of study medication. This outcome measure was not planned to be analyzed for Cycles 1-4: HSP-130 6mg arm.|||hour*10^9 Neutrophils per Liter||Standard Deviation|Mean
2561476|NCT02650128|Secondary|180 Day MACE|"MACE defined as:~Cardiac death~Myocardial Infarction - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave~TVR - defined as revascularization at the target vessel (inclusive the target lesion) after the completion of the index procedure"|180 days post-procedure|No imputation of or adjustments for missing data were performed for the primary analyses. The population for all analysis was the Intent-To-Treat (ITT) analysis set. ITT was defined as those subjects who had insertion of the Lithoplasty catheter attempted, defined as the point of enrollment.|||events|||Number
2561477|NCT02650128|Secondary|Quantitative Assessment of the Residual Stenosis in Treated Lesions|Angiographic success defined as success in facilitating stent deliver with <50% residual stenosis and without serious angiographic complications. Serious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow|Post-procedure (within 24 hours following procedure and prior to discharge)|No imputation of or adjustments for missing data were performed for the primary analyses. The population for all analysis was the Intent-To-Treat (ITT) analysis set. ITT was defined as those subjects who had insertion of the Lithoplasty catheter attempted, defined as the point of enrollment.|||Participants|||Count of Participants
2561478|NCT02650128|Primary|Performance|"The ability of the Shockwave System to produce acceptable residual stenosis (<50%) after stenting with no evidence of in-hospital MACE.~Clinical success measured by each patient that achieves both these requirements."|Post-procedure (within 24 hours following procedure and prior to discharge)|No imputation of or adjustments for missing data were performed for the primary analyses. The population for all analysis was the Intent-To-Treat (ITT) analysis set. ITT was defined as the subjects who had insertion of the Lithoplasty catheter attempted, defined as the point of enrollment.|||Participants|||Count of Participants
2561479|NCT02650128|Primary|Safety - Frequency of Major Adverse Cardiac Events (MACE) Within 30 Days of the Procedure.|"MACE defined as:~Cardiac death~Myocardial Infarction - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave~TVR - defined as revascularization at the target vessel (inclusive the target lesion) after the completion of the index procedure"|30 days|No imputation of or adjustments for missing data were performed for the primary analyses. The population for all analysis was the Intent-To-Treat (ITT) analysis set. ITT was defined as those subjects who had insertion of the Lithoplasty catheter attempted, defined as the point of enrollment.|||events|||Number
2561480|NCT02649946|Secondary|Endpoint Without Hypothesis Testing: Number of Participants With Procedure Success|"Procedure Success is defined as anatomic success and resolution of the pre-procedural clinical indicator(s) (clinical success) of a hemodynamically significant stenosis.~Procedure success was assessed on the day the index procedure was performed, which may be a different day for each participant."|On Day of Index Procedure|Procedure Success (mITT Subjects). Number of participants (n) included in this analysis is different from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria.|||Participants|||Count of Participants
2561481|NCT02649946|Secondary|Endpoint Without Hypothesis Testing: Number of Participants withTechnical Success (for Stent Graft Placement)|"Technical Success is defined as successful deployment, based on the operator's opinion, of the implant to the intended location assessed at the time of the index procedure. Therefore, for this measure, only COVERA data are relevant.~mITT results are presented. Number of participants (n) included in this analysis is different from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria.~Technical success was assessed on the day the index procedure was performed, which may be a different day for each participant."|On Day of Index Procedure|Number of Participants with Acute Technical Success (mITT Subjects). Please note that “Technical Success is defined as successful deployment, based on the operator’s opinion, of the implant to the intended location assessed at the time of the index procedure.” Therefore, for this measure, only COVERA data are relevant.|||Participants|||Count of Participants
2561518|NCT02649634|Secondary|BMI at 6 Month Follow up|A digital scale (Tanita BWB-800S), which assessed weight to the nearest 0.1 kg, was used to assess weight for the 6 month follow up assessment, and the height measured at the beginning of the behavioural weight loss program was used to calculate BMI. BMI was calculated as weight in Kilograms divided by height in meter squared.|Mean BMI 6 months after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||kg/m2||Standard Error|Mean
2561482|NCT02649946|Secondary|Endpoint Without Hypothesis Testing: Number of Participants With Post-intervention Secondary Patency|"Secondary Patency is defined as the interval after the index intervention until the access is abandoned. Multiple repetitive treatments can be included in post-intervention secondary patency.~Whereas the measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months, the interim report only provides the 1, 3, and 6 months results. The 12,18 and 24 months results will be provided in the final reporting for the study.~mITT subjects results are presented."|1, 3, 6, 12, 18 and 24 months post index procedure|Post-Intervention Secondary Patency by Follow-Up Period (mITT Subjects). (n) varies in relation to the number of failures (access abandonment) recorded at 30 days, 90 days and 6 months. Accordingly, the (n) for each period may be different from the overall (N) reported in the Participant Flow section.|||Participants|||Count of Participants
2561483|NCT02649946|Secondary|Endpoint Without Hypothesis Testing: Index of Patency Function - Target Lesion (IPF-T)|"IPF-T (Index of Patency Function - Target Lesion) is defined as the time from the index study procedure to study completion or complete access abandonment divided by the number of visits for a reintervention performed at the target lesion in order to maintain vascular access for hemodialysis.~Whereas the measure time frames for the overall study are 1, 3, 6, 12, 18 and 24 months, the interim report only provides the 1, 3, and 6 months results. The 12, 18 and 24 months results will be provided in the final reporting for the study.~The IPF for target lesion patency is representative of the approximate (mean) number of days between interventions to maintain target lesion patency. Higher values represent a better outcome, that is, more time elapsed between the Index study procedure and reinterventions."|1, 3, 6, 12, 18 and 24 months post index procedure|"Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 3 months and 6 months follow-up or did not meet endpoint inclusion criteria.~mITT subjects results are presented."|||Days||Standard Deviation|Mean
2561484|NCT02649946|Secondary|Endpoint Without Hypothesis Testing: Index of Patency Function (IPF)|"IPF is defined as the time from the index study procedure to study completion or access abandonment divided by the number of visits for a reintervention performed on the AV access circuit in order to maintain vascular access for hemodialysis. A visit is defined as one (1) procedural event, regardless of the number or type of interventions performed during the visit. The index procedure is counted as the first visit to ensure all subjects have a denominator of at least one.~Whereas the measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months, the preliminary report only provides the 1, 3, and 6 months results. The 12,18 and 24 months results will be provided in the final reporting for the study.~The IPF is representative of the number of days between interventions to maintain access circuit patency. Higher values represent a better outcome, that is, more time elapsed between the Index study procedure and reinterventions.~mITT results are analyzed."|1, 3, 6, 12, 18 and 24 months post index procedure|"Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 3 months and 6 months follow-up or did not meet endpoint inclusion criteria.~mITT subjects results are presented."|||Days||Standard Deviation|Mean
2561485|NCT02649946|Secondary|Endpoint Without Hypothesis Testing: Total Number of Target Lesion Reinterventions|"Total Number of Target Lesion Reinterventions defined as the number of reinterventions to maintain target lesion patency (mITT subjects).~Whereas the outcome measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months, this preliminary results report only provides the 1, 3, and 6 months results. The 12,18 and 24 months results will be provided in the final reporting for the study."|1, 3, 6, 12, 18 and 24 months post index procedure|"The (n) in each follow-up periods vary from overall enrollment (N) as some subjects discontinued participation before each follow-up or did not meet endpoint inclusion criteria.~The total number of Target Lesion Reinterventions by Follow-Up Period was analyzed as opposed to the number of subjects with at least one AV Target Lesion Reintervention."|||Target Lesion Reinterventions|||Number
2561486|NCT02649946|Secondary|Endpoint Without Hypothesis Testing: Total Number of Arteriovenous (AV) Access Circuit Reinterventions|"Defined as the number of reinterventions to the AV access circuit until access abandonment or through study completion.~Whereas the outcome measure time frames for the overall study are 1, 3, 6, 12,18 and 24 months, the interim report only provides the 1, 3, and 6 months results. The 12,18 and 24 months results will be provided in the final reporting for the study.~MITT results are presented for this analysis."|1, 3, 6, 12, 18 and 24 months post index procedure|"The (n) in each follow-up periods vary from overall enrollment (N) as some subjects discontinued participation before each follow-up or did not meet endpoint inclusion criteria.~The total number of Reinterventions by Follow-Up Period was analyzed as opposed to the number of subjects with at least one AV Access Circuit Reintervention -mITT subjects"|||AV Access Circuit Reinterventions|||Number
2561487|NCT02649946|Secondary|Endpoint Without Hypothesis Testing: Number of Participants Free From Device and Procedure Related AEs Involving the AV Access Circuit|"Number of Participants Free from Device and Procedure Related AEs Involving the AV Access Circuit (ITT population).~Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria.~The relationships with device/procedure of the events are based on CEC adjudications.~Evaluation through 1, 3, 6, 12, 18 and 24 months post index procedure although at the time of reporting, only the 1, 3 and 6 months data was available."|Evaluation through 1, 3, 6, 12, 18, and 24 months post-index procedure|"Number of Participants Free from Device and Procedure (DP) Related AEs Involving the AV Access Circuit (ITT subjects).~Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days, 90 days and 6 months follow-up or did not meet endpoint inclusion criteria."|||Participants|||Count of Participants
2561488|NCT02649946|Secondary|Endpoint Without Hypothesis Testing: Number of Participants With Access Circuit Primary Patency (ACPP)|"ACPP is defined as the interval following the index intervention until the next access thrombosis or repeated intervention.~N = number of subjects in the mITT Population with evaluable data.~Evaluation through 1, 3, 12, 18 and 24 months post index procedure although at the time of reporting to CT.gov, only the 1 and 3 months data was available."|1, 3, 12, 18, and 24 months post index procedure|Number of Participants with ACPP by Follow-up Period (mITT subjects). Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days and 90 days follow-up or did not meet endpoint inclusion criteria.|||Participants|||Count of Participants
2561489|NCT02649946|Secondary|Endpoint Without Hypothesis Testing: Number of Participants With Target Lesion Primary Patency (TLPP)|"Defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site or until the extremity is abandoned for permanent access.~mITT subjects results are presented. N= number of subjects in the mITT Population with evaluable data. Evaluation through 1, 3, 18 and 24 months post index procedure although at the time of this reporting, only the 1 and 3 months data was available.~Secondary endpoints without formal hypothesis testing are limited to descriptive statistics and are presented, for this outcome, at 1 and 3 months follow-up."|1 and 3 months post index procedure|Number of Participants with Target Lesion Primary Patency (TLPP). Number of participants (n) in each follow-up periods varies from overall enrollment (N) as some subjects discontinued participation before the 30 days or 90 days follow-up or did not meet endpoint inclusion criteria.|||Participants|||Count of Participants
2561490|NCT02649946|Secondary|Endpoint With Hypothesis Testing: Number of Participants With Access Circuit Primary Patency (ACPP).|"ACPP is defined as the interval following the index intervention until the next access thrombosis or repeated intervention.~ACPP ends with a reintervention anywhere within the access circuit. Vessel rupture caused by PTA is not an ACPP failure unless achieving hemostasis also causes thrombosis.~Testing of this secondary endpoint is performed in a hierarchical fashion.Thus, In order to perform hypothesis test of ACPP at 6-month, TLPP at 12-months must be successful.Since not all TLPP at 12-month results were available at time of interim CSR report, results of ACPP at 6-month will be presented when the final report for the study is completed."|6 months post index procedure|||||||
2561491|NCT02649946|Secondary|Endpoint With Hypothesis Testing: Number of Patients With Target Lesion Primary Patency (TLPP) at 12 Months Post Index Procedure|TLPP is defined as the interval following the index intervention until the next clinically driven reintervention at the original treatment site or until the extremity is abandoned for permanent access. Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV fistula due to inability to treat the original treatment area. Not all TLPP 12-month data were available at the time of writing the interim analysis report, therefore, the results for this outcome measure will be presented when the final study report is completed.|12 months post-index procedure|||||||
2561492|NCT02649946|Primary|Number of Participants With Freedom From AV Access Circuit Localized or Systemic Serious Adverse Events|Safety is defined as freedom from any adverse event(s) (AEs), localized or systemic, that reasonably suggests the involvement of the AV access circuit (not including stenosis or thrombosis) that require or result in any of the following alone or in combination: additional interventions (including surgery); in-patient hospitalization or prolongation of an existing hospitalization; or death.|30 days post index procedure|Number of Participants Free from Primary Safety Events. All Intended to Treat Subjects (ITT) are included in this analysis. Primary safety endpoint evaluated against standard PTA alone.2 subjects excluded from N COVERA due to discontinuation or death prior to day 23 of follow up. One subject excluded from N PTA arm due to death prior to follow up.|||Participants|||Count of Participants
2561493|NCT02649946|Primary|Effectiveness Endpoint: Number of Participants With Target Lesion Primary Patency (TLPP)|TLPP is defined as the interval following the index intervention until the next clinically driven reintervention at, or adjacent to,the original treatment site or until the extremity is abandoned for permanent access. Primary patency ends when any of the following occurs: a) clinically driven reintervention in the treatment area; b) thrombotic occlusion within the treatment area; c) surgical intervention that excludes the original treatment area from the AV circuit, and/or d) abandonment of the AV fistula due to inability to treat the original treatment area. COVERA Vascular Covered Stent (following PTA) is evaluated against subjects treated PTA alone.|6 months post index procedure|Number of Participants with Target Lesion Primary Patency. Modified Intended to Treat (mITT) population results were analyzed for this effectiveness endpoint. N = number of subjects in mITT population with evaluable data. Excluded subjects that discontinued, expired and or access abandoned prior to day 15.|||Participants|||Count of Participants
2561494|NCT02649842|Other Pre-specified|Percent Change in Cylinder|Percent change in cylinder= ((postop refractive cylinder-preop keratometric cylinder) / (Target refractive cylinder-preop keratometric cylinder))*100|6 months|All subjects implanted with a ZCT450/525/600 in at least one eye|||Percent change||Standard Deviation|Mean
2561495|NCT02649842|Other Pre-specified|Rate of IOL Repositioning Due to IOL Misalignment|Rate of IOL repositioning due to IOL misalignment in primary and fellow eyes with a high cylinder toric IOL|6 months|All subjects implanted with a ZCT450/525/600 in at least one eye|||Participants|||Count of Participants
2561496|NCT02649842|Primary|Rate of Severe Visual Distortions|Rate of severe visual distortions based on data from a self administered subject questionnaire|6 months|All subjects implanted with a high cylinder toric IOL (model ZCT450, ZCT525 or ZCT600) in at least one eye and a high cylinder or low cylinder toric IOL in the fellow eye.|||Participants|||Count of Participants
2561497|NCT02649634|Secondary|Confidence for Change Ratings After the Second Motivational Interviewing or Attention Control Interview, Week 12|"Self-report ratings of confidence for change after the second motivational interview or attention control interview, on 11-point visual analogue scales (Miller & Rollnick, 2002). For the visual analogue scales, participants were asked to rate how confident they feel about succeeding with losing weight on a scale from 0 not confident to 10 was very confident. Thus lower scores reflect lower levels of confidence for change, and higher scores reflect higher levels of confidence for change. Their raw score from 0 to 10 on this measure was taken as their Confidence for Change rating score."|Confidence for change ratings measured immediately after the second MI or attention control interview (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||scores on a scale||Standard Deviation|Mean
2561531|NCT02649322|Primary|Baseline Pain Assessment Before Knee Arthroscopy Via the Visual Analog Scale.|Pain will be assessed via the Visual Analog Scale by the patient before administration of the nerve block. Patient will report on a scale of 0 to 10 what their perceived pain is. 0 is no pain with 10 being worst pain patient ever experienced.|During Baseline Assessment, Taking Approximately 20 Minutes, Before Nerve Block|Comparison of the mean pain on visual analog scale|||score on a scale||Standard Deviation|Mean
2561498|NCT02649634|Secondary|Readiness for Change Ratings After the Second Motivational Interviewing or Attention Control Interview, Week 12|"Self-report ratings of readiness for change after the second motivational interview or attention control interview, on 11-point visual analogue scales (Miller & Rollnick, 2002). For the visual analogue scales, participants were asked to rate how ready they are to lose weight on a scale from 0 not ready to 10 was very ready. Thus lower scores reflect lower levels of readiness for change, and higher scores reflect higher levels of readiness for change. Their raw score from 0 to 10 on this measure was taken as their Readiness for Change rating score."|Readiness for change ratings measured immediately after the second MI or attention control interview (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||scores on a scale||Standard Deviation|Mean
2561499|NCT02649634|Secondary|Importance for Change Ratings After the Second Motivational Interview or Attention Control Interview, Week 12|"Self-report ratings of importance of change after the second motivational interview or attention control interview, on 11-point visual analogue scales (Miller & Rollnick, 2002). For the visual analogue scales, participants were asked to rate how important it is for them personally to lose weight on a scale from 0 not important to 10 was very important. Thus lower scores reflect lower levels of importance for change, and higher scores reflect higher levels of importance for change. Their raw score from 0 to 10 on this measure was taken as their Importance for Change rating score."|Importance of change ratings measured immediately after the second MI or attention control interview (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||scores on a scale||Standard Deviation|Mean
2561500|NCT02649634|Secondary|Confidence for Change Ratings After the First Motivational Interview or Attention Control Interview, Week 1- 2|"Self-report ratings of confidence for change after the first motivational interview or attention control interview, on 11-point visual analogue scales (Miller & Rollnick, 2002). For the visual analogue scales, participants were asked to rate how confident they feel about succeeding with losing weight on a scale from 0 not confident to 10 was very confident. Thus lower scores reflect lower levels of confidence for change, and higher scores reflect higher levels of confidence for change. Their raw score from 0 to 10 on this measure was taken as their Confidence for Change rating score."|Confidence for change ratings measured immediately after the first MI or attention control interview (week 1- 2)||||scores on a scale||Standard Deviation|Mean
2561501|NCT02649634|Secondary|Readiness for Change Ratings After the First Motivational Interview or Attention Control Interview, Week 1 -2|"Self-report ratings of readiness for change after the first motivational interview or attention control interview, on 11-point visual analogue scales (Miller & Rollnick, 2002). For the visual analogue scales, participants were asked to rate how ready they are to lose weight on a scale from 0 not ready to 10 was very ready. Thus lower scores reflect lower levels of readiness for change, and higher scores reflect higher levels of readiness for change. Their raw score from 0 to 10 on this measure was taken as their Readiness for Change rating score."|Readiness for change ratings measured immediately after the first MI or attention control interview (week 1- 2)||||scores on a scale||Standard Deviation|Mean
2561502|NCT02649634|Secondary|Importance of Change Ratings After the First Motivational Interview or Attention Control Interview, Week 1 - 2|"Self-report ratings of importance of change after the first motivational interview or attention control interview, on 11-point visual analogue scales (Miller & Rollnick, 2002). For the visual analogue scales, participants were asked to rate how important it is for them personally to lose weight on a scale from 0 not important to 10 was very important. Thus lower scores reflect lower levels of importance for change, and higher scores reflect higher levels of importance for change. Their raw score from 0 to 10 on this measure was taken as their Importance for Change rating score."|Importance of change ratings measured immediately after the first MI or attention control interview (week 1- 2)||||scores on a scale||Standard Deviation|Mean
2561503|NCT02649634|Secondary|Self-efficacy for Engaging in Physical Activity After the Second Motivational Interviewing or Attention Control Interview, Week 12|Self-efficacy for engaging in physical activity was measured by the Exercise Self-Efficacy questionnaire (ESE; Nigg & Riebe, 2002). Participants rate their confidence that they could exercise on a 5-point Likert scale for six barriers to exercise (e.g., bad weather, stress, availability of equipment). Consists of a global score as well as four subscales: Eating Concern, Restraint, Shape Concern, and Weight Concern. The global score is obtained by summing the subscale scores and then dividing this sum by the number of subscales (i.e. four). Range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).|Mean self-efficacy for engaging in physical activity measured immediately after the second MI or attention control interview (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||ESE score||Standard Deviation|Mean
2561504|NCT02649634|Secondary|Self-efficacy Related to Eating Patterns After the Second Motivational Interviewing or Attention Control Interview, Week 12|Self-efficacy related to eating patterns was measured by the Weight Efficacy Life-Style Questionnaire (WEL; Clark, Abrams, Niaura, Eaton, & Rossi, 1991). This self-report questionnaire yields five subscale scores, which rate self-efficacy for controlling eating in different situations/dimensions: negative emotions, availability, social pressure, physical discomfort, and positive activities. A global/total score (which ranges from 0 - 180) is obtained by summing the scores of each of the five subscales. Higher scores are indicative of greater self-efficacy (i.e., higher scores = better outcome).|Mean self-efficacy related to eating patterns measured immediately after the second MI or attention control interview (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||Global score on WEL||Standard Deviation|Mean
2561532|NCT02649192|Secondary|HAI Titers at Day 56 After Vaccination, by Vitamin A Levels at Screening||Day 56 after vaccination|Subjects with complete HAI data at day 56. Subjects without a day 56 sample were not included in analyses.|||titers||Full Range|Median
2561505|NCT02649634|Secondary|Self-efficacy for Engaging in Physical Activity After the First Motivational Interviewing or Attention Control Interview, Week 1- 2|Self-efficacy for engaging in physical activity was measured by the Exercise Self-Efficacy questionnaire (ESE; Nigg & Riebe, 2002). Participants rate their confidence that they could exercise on a 5-point Likert scale for six barriers to exercise (e.g., bad weather, stress, availability of equipment). Consists of a global score as well as four subscales: Eating Concern, Restraint, Shape Concern, and Weight Concern. The global score is obtained by summing the subscale scores and then dividing this sum by the number of subscales (i.e. four). Range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).|Mean self-efficacy for engaging in physical activity measured immediately after the first MI or attention control interview (week 1 - 2)||||ESE score||Standard Deviation|Mean
2561506|NCT02649634|Secondary|Self-efficacy Related to Eating Patterns After the First Motivational Interviewing or Attention Control Interview, Week 1 - 2|Self-efficacy related to eating patterns was measured by the Weight Efficacy Life-Style Questionnaire (WEL; Clark, Abrams, Niaura, Eaton, & Rossi, 1991). This self-report questionnaire yields five subscale scores, which rate self-efficacy for controlling eating in different situations/dimensions: negative emotions, availability, social pressure, physical discomfort, and positive activities. A global/total score (which ranges from 0 - 180) is obtained by summing the scores of each of the five subscales. Higher scores are indicative of greater self-efficacy (i.e., higher scores = better outcome).|Mean self-efficacy related to eating patterns measured immediately after the first MI or attention control interview (week 1 to 2)||||Global score on WEL||Standard Deviation|Mean
2561507|NCT02649634|Secondary|Eating Disorder Symptomology at 6 Month Follow up|Eating disorder symptomology was measured using the Eating Disorder Examination-Questionnaire (EDE-Q; Fairburn & Beglin, 1994). This self-report questionnaire assesses the presence and degree of specific psychopathology associated with eating disorders over the previous 28 days. Consists of a global score as well as four subscales: Eating Concern, Restraint, Shape Concern, and Weight Concern. The global score is obtained by summing the subscale scores and then dividing this sum by the number of subscales (i.e. four). Range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).|Mean eating disorder symptomology as measured by the global EDE-Q score, 6 months after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||Global EDE-Q score||Standard Error|Mean
2561508|NCT02649634|Secondary|Eating Disorder Symptomology at 1 Month Follow up|Eating disorder symptomology was measured using the Eating Disorder Examination-Questionnaire (EDE-Q; Fairburn & Beglin, 1994). This self-report questionnaire assesses the presence and degree of specific psychopathology associated with eating disorders over the previous 28 days. Consists of a global score as well as four subscales: Eating Concern, Restraint, Shape Concern, and Weight Concern. The global score is obtained by summing the subscale scores and then dividing this sum by the number of subscales (i.e. four). Range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).|Mean eating disorder symptomology as measured by the global EDE-Q score, 1 month after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||Global EDE-Q score||Standard Error|Mean
2561509|NCT02649634|Secondary|Eating Disorder Symptomology at End of the Behavioural Weight Loss Program, Week 12|Eating disorder symptomology was measured using the Eating Disorder Examination-Questionnaire (EDE-Q; Fairburn & Beglin, 1994). This self-report questionnaire assesses the presence and degree of specific psychopathology associated with eating disorders over the previous 28 days. Consists of a global score as well as four subscales: Eating Concern, Restraint, Shape Concern, and Weight Concern. The global score is obtained by summing the subscale scores and then dividing this sum by the number of subscales (i.e. four). Range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).|Mean eating disorder symptomology as measured by the global EDE-Q score, at the end of the behavioural weight loss program (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||Global EDE-Q score||Standard Error|Mean
2561510|NCT02649634|Secondary|Blood Pressure at 6 Month Follow up|A measure of systolic and diastolic blood pressure was taken in a standardized manner according to the Canadian Hypertension Education Program Guidelines (Hemmelgarn et al., 2006). Three different readings of blood pressure were taken at each time point (baseline and 6 month follow up), and the average of the three readings was taken as the measure of blood pressure for each time point.|Mean blood pressure 6 months after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||mmHg||Standard Error|Mean
2561511|NCT02649634|Secondary|Blood Pressure at End of the Behavioural Weight Loss Program, Week 12|A measure of systolic and diastolic blood pressure was taken in a standardized manner according to the Canadian Hypertension Education Program Guidelines (Hemmelgarn et al., 2006). Three different readings of blood pressure were taken at each time point (baseline and end of behavioural weight loss program), and the average of the three readings was taken as the measure of blood pressure for each time point.|Mean blood pressure at the end of the behavioural weight loss program (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||mmHg||Standard Error|Mean
2561533|NCT02649192|Secondary|HAI Titers at Day 56 After Vaccination, Overall||Day 56 after vaccination|Subjects with complete HAI data at day 56. Subjects without a day 56 sample were not included in analyses.|||titers||Full Range|Median
2564519|NCT02608099|Other Pre-specified|Number of Patients With TIAs or Non-Hemorrhagic Strokes|This measurement includes TIAs or non-hemorrhagic strokes.|Randomization to 1 month post catheter ablation||||Participants|||Count of Participants
2561512|NCT02649634|Secondary|Dietary Behaviour at 6 Month Follow up|Dietary behaviour was measured by the Fat-related Dietary Habits Questionnaire (DHQ; Kristal, Shattuck, & Henry, 1990). This self-report questionnaire assesses dietary behaviours and high-fat eating patterns and consists of an overall summary score and five subscale scores assessing different dimensions of fat-related dietary habits. The DHQ consists of an overall summary score and five subscale scores assessing different dimensions of fat-related dietary habits. The overall summary score is the mean of all non-missing subscales scores. Responses are scored on a 4-point scale (usually, often, sometimes, rarely/never). Range of overall summary score is 1 - 4. Higher scores correspond to higher fat intakes (i.e., higher scores = worse outcome).|Mean dietary behaviour score as measured by the overall DHQ score, 6 months after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||Overall score on DHQ||Standard Error|Mean
2561513|NCT02649634|Secondary|Dietary Behaviour at 1 Month Follow up|Dietary behaviour was measured by the Fat-related Dietary Habits Questionnaire (DHQ; Kristal, Shattuck, & Henry, 1990). This self-report questionnaire assesses dietary behaviours and high-fat eating patterns and consists of an overall summary score and five subscale scores assessing different dimensions of fat-related dietary habits. The DHQ consists of an overall summary score and five subscale scores assessing different dimensions of fat-related dietary habits. The overall summary score is the mean of all non-missing subscales scores. Responses are scored on a 4-point scale (usually, often, sometimes, rarely/never). Range of overall summary score is 1 - 4. Higher scores correspond to higher fat intakes (i.e., higher scores = worse outcome).|Mean dietary behaviour score as measured by the overall DHQ score, 1 month after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||Overall score on DHQ||Standard Error|Mean
2561514|NCT02649634|Secondary|Dietary Behaviour at End of the Behavioural Weight Loss Program, Week 12|Dietary behaviour was measured by the Fat-related Dietary Habits Questionnaire (DHQ; Kristal, Shattuck, & Henry, 1990). This self-report questionnaire assesses dietary behaviours and high-fat eating patterns and consists of an overall summary score and five subscale scores assessing different dimensions of fat-related dietary habits. The DHQ consists of an overall summary score and five subscale scores assessing different dimensions of fat-related dietary habits. The overall summary score is the mean of all non-missing subscales scores. Responses are scored on a 4-point scale (usually, often, sometimes, rarely/never). Range of overall summary score is 1 - 4. Higher scores correspond to higher fat intakes (i.e., higher scores = worse outcome).|Mean dietary behaviour score as measured by the overall DHQ score, at the end of the behavioural weight loss program (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||overall score on DHQ||Standard Error|Mean
2561515|NCT02649634|Secondary|Physical Activity at 6 Month Follow up|Physical activity was measured by the Paffenbarger questionnaire (PPAQ; Paffenbarger, Wing, & Hyde, 1978). This self-report questionnaire assesses amount of activity performed during a typical week, and consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants were asked to report the frequency and duration of physical activity in the past week. Participants report the frequency and duration of physical activity in the past week. Scoring yields energy expenditure from physical activity per week (kcal/kg/week). Higher scores translate into greater energy expenditure per week (i.e.,better outcome). Range is 0 - no theoretical maximum. Highest observed score in our study was 10902 kcal/kg/week.|Mean physical activity as measured by the PPAQ, 6 months after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||kilocalories per week||Standard Error|Mean
2561516|NCT02649634|Secondary|Physical Activity at 1 Month Follow up|Physical activity was measured by the Paffenbarger questionnaire (PPAQ; Paffenbarger, Wing, & Hyde, 1978). This self-report questionnaire assesses amount of activity performed during a typical week, and consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants were asked to report the frequency and duration of physical activity in the past week. Participants report the frequency and duration of physical activity in the past week. Scoring yields energy expenditure from physical activity per week (kcal/kg/week). Higher scores translate into greater energy expenditure per week (i.e.,better outcome). Range is 0 - no theoretical maximum. Highest observed score in our study was 10902 kcal/kg/week.|Mean physical activity as measured by the PPAQ, 1 month after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||kilocalories per week||Standard Error|Mean
2561517|NCT02649634|Secondary|Physical Activity at End of the Behavioural Weight Loss Program, Week 12|Physical activity was measured by the Paffenbarger questionnaire (PPAQ; Paffenbarger, Wing, & Hyde, 1978). This self-report questionnaire assesses amount of activity performed during a typical week, and consists of three components: (1) stair climbing, (2) walking, and (3) sports and recreation. Participants were asked to report the frequency and duration of physical activity in the past week. Participants report the frequency and duration of physical activity in the past week. Scoring yields energy expenditure from physical activity per week (kcal/kg/week). Higher scores translate into greater energy expenditure per week (i.e.,better outcome). Range is 0 - no theoretical maximum. Highest observed score in our study was 10902 kcal/kg/week.|Mean physical activity as measured by the PPAQ, at the end of the behavioural weight loss program (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||kilocalories per week||Standard Error|Mean
2561519|NCT02649634|Secondary|BMI at End of Behavioural Weight Loss Program, Week 12|Weight was measured to the nearest 0.1 kg using a balance beam scale, height was measured to the nearest 0.1 cm using a stadiometer at the beginning of the behavioural weight loss program. BMI was calculated as weight in Kilograms divided by height in meters squared.|Mean BMI at the end of the behavioural weight loss program (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||kg/m2||Standard Error|Mean
2561520|NCT02649634|Secondary|Adherence|The mean number of missed behavioural weight loss sessions (out of 24 sessions)|Assessed once at the end of the behavioural weight loss program (week 12)||||number of group sessions||Standard Deviation|Mean
2561521|NCT02649634|Secondary|Weight at 6 Month Follow up|a digital scale (Tanita BWB-800S), which assessed weight to the nearest 0.1 kg, was used for the 6 month follow-up assessment|Mean weight 6 months after the end of the behavioural weight loss program|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||kilograms||Standard Error|Mean
2561522|NCT02649634|Primary|Weight at End of Behavioural Weight Loss Program, 12 Weeks|Weight was measured to the nearest 0.1 kg using a balance beam scale|Mean weight recorded at the end of the behavioural weight loss program (week 12)|The participant numbers above represent the number of people that were analyzed on this specific outcome measure, which varies outcome to outcome, and does not necessarily match the number of participants that completed interviews at various stages as listed in the Participant Flow Module.|||kilograms||Standard Error|Mean
2561523|NCT02649608|Primary|"Duration of ON Time"|"ON state is defined as a period of good control of parkinsonian features with relatively good overall function and mobility. Motor fluctuation assessments are patient-reported outcomes, and guidance will be given to the patients on how to complete them. Date and time will be registered when the patient turns to ON and OFF state. OFF state is defined as a period of poor control of parkinsonian features with relatively poor overall function, such as worsening tremor, rigidity, balance or bradykinesia. Outcome measured in minutes.~Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON' following administration of Lu AE04621."|From dosing up to 24h post-dose|Each patient received 3 or 4 doses of Lu AE04621. The overall number analyzed in each group represents the number of dosing occasion at a particular dose when patients turned 'ON'. Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON'.|||minutes||Standard Deviation|Mean
2561524|NCT02649608|Primary|"Time to Onset of ON Time After Lu AE04621 Administration"|"ON state is defined as a period of good control of parkinsonian features with relatively good overall function and mobility. Motor fluctuation assessments are patient-reported outcomes, and guidance will be given to the patients on how to complete them. Date and time will be registered when the patient turns to ON and OFF state. OFF state is defined as a period of poor control of parkinsonian features with relatively poor overall function, such as worsening tremor, rigidity, balance or bradykinesia.~Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON'."|From dosing to 90 minutes after dosing|Each patient received 3 or 4 doses of Lu AE04621. The overall number of participants analyzed in each group represents the number of dosing occasion at a particular dose. Data are no presented for the dose groups 0.04, 0.08, and 1.0 mg Lu AE04621 since no patients turned 'ON'.|||minutes|dosing occasion when patient turned ON|Standard Deviation|Mean
2561525|NCT02649608|Primary|Apparent Elimination Half-life of Lu AE04621 in Plasma (t½)||From dosing to up to 24 hours after dosing|The overall number of participants analyzed in each group represents the number of dosing occasion at a particular dose, minus occasions with missing or unreliable data. The results are reported for the dose groups with sufficient data to calculate the parameter (missing dose groups for t½ are: 0.04, 0.08, 0.8, 1.0 and 1.2 mg)|||hour||Standard Deviation|Mean
2561526|NCT02649608|Primary|Maximum Observed Concentration (Cmax) for Lu AE04621||From dosing to up to 24 hours after dosing|Each patient received 3 or 4 doses of Lu AE04621. The overall number of participants analyzed in each group represents the number of dosing occasion at a particular dose, minus occasions with missing or unreliable data.|||pg/mL||Standard Deviation|Mean
2561527|NCT02649608|Primary|Area Under the Plasma Concentration-time Curve (AUC(0-24 Hours)) for Lu AE04621||From dosing to up to 24 hours after dosing|The overall number of participants analyzed in each group represents the number of dosing occasion at a particular dose, minus occasions with missing or unreliable data. The results are reported for the dose groups with sufficient data to calculate the parameter (missing dose groups for AUC(0-24 hours) are: 0.04, 0.08, 0.8, 1.0 and 1.2 mg)|||pgxh/mL||Standard Deviation|Mean
2561528|NCT02649608|Primary|Safety and Tolerability Based on the Safety Variables (Adverse Events, Clinical Safety Laboratory Tests, Vital Signs, Weight, and ECG)|Number of patients with an adverse event|Baseline to day 11|Each patient received 3 or 4 doses of Lu AE04621. The overall number of participants analyzed in each group represents the number of patients having received a particular dose.|||Participants|||Count of Participants
2561529|NCT02649322|Secondary|Satisfaction Via a 0 to 10 Rating Scale at Follow up|Patients will be asked to describe how satisfied they were with the knee arthroscopy via a 0 to 10 rating scale. Patient will report on a scale of 0 to 10 what their perceived satisfaction is. 0 is no satisfaction with 10 most satisfaction.|At the follow up appointment, an average of one week after the procedure.|Comparison of the mean satisfaction on visual analog scale|||score on a scale||Standard Deviation|Mean
2561530|NCT02649322|Primary|Pain Assessment After Knee Arthroscopy Via the Visual Analog Scale|Pain will be assess via the Visual Analog Scale by the patient after the knee arthroscopy though first post op office visit and average of one week. Patient will report on a scale of 0 to 10 what their perceived pain is. 0 is no pain with 10 being worst pain patient ever experienced.|During Follow-up Assessment at an Average of 1 Week Post Op|Comparison of the mean pain on visual analog scale|||units on a scale||Standard Deviation|Mean
2561548|NCT02648646|Secondary|30-second Chair Stand Test|Participant rises from chair to full standing position and sits back down as quickly as possible for 30 seconds. Number of completed sit to stand to sit maneuvers is recorded.|Month 6||||completed maneuvers||Full Range|Median
2561534|NCT02649192|Secondary|Percentage of Participants With Seroconversion at Day 56 After Vaccination, by Vitamin A Levels at Screening|Secondary analyses will examine sero-conversion based on antibody functions (HAI or neutralization) defined as antibody titers of <1:40 converting to ≥1:40, or a four-fold increase in titer for participants with a starting titer of ≥1:40. Sero-conversion rate (expressed as percentage) will be estimated with 95% confidence interval for participants sufficient and insufficient in vitamin A at screening.|Day 56 after vaccination|Subjects with complete HAI data at day 56. Subjects without a day 56 sample were not included in analyses.|||percentage of participants||95% Confidence Interval|Number
2561535|NCT02649192|Secondary|Percentage of Participants With Seroconversion at Day 56 After Vaccination, Overall|Secondary analyses will examine sero-conversion based on antibody functions (HAI or neutralization) defined as antibody titers of <1:40 converting to ≥1:40, or a four-fold increase in titer for participants with a starting titer of ≥1:40. Sero-conversion rate (expressed as percentage) will be estimated with 95% confidence interval. The rate difference will be described with point estimate and 95% confidence interval.|Day 56 after vaccination|Subjects with complete HAI data at day 56. Subjects without a day 56 sample were not included in analyses.|||percentage of participants||95% Confidence Interval|Number
2561536|NCT02649192|Primary|Isotype Ratios on Day 56|Isotype ratios will be summarized with descriptive statistics.|Day 56 after vaccination|Subjects with complete isotype data at day 56. Subjects with an undetermined assay result were not included in analyses. In some cases, the limit of detection (LOD) for the assay was reached and that LOD value was used in calculations.|||ratio||Full Range|Median
2561537|NCT02649192|Primary|Percentage of Participants With Positive Responses in Virus-specific Antibody in Sera|The percentage of 2X increases or conversion from undetectable to detectable response in virus-specific antibody toward any vaccine component after 2 immunizations in intervention and control groups will be reported.|Day 56 after vaccination|All enrolled subjects who satisfied the inclusion/exclusion criteria were included in the analysis. For the four participants who didn’t complete the study, results after one immunization were used.|||percentage of participants|||Number
2561538|NCT02648646|Secondary|Rapid Assessment of Physical Activity: Aerobic Score|"Participants are asked to identify from a list of 7 items which one accurately describes their current level of aerobic physical activity. Participants who identify with items 6 or 7 are considered active. Those who identify with items 1-5 are considered to have suboptimal aerobic physical activity levels.~Sedentary:~I rarely or never do any physical activities.~Under-active:~I do some light or moderate physical activities, but not every week.~Under-active regular - light activities:~I do some light physical activity every week.~Under-active regular:~I do moderate physical activities every week, but less than 30 minutes a day or 5 days a week.~I do vigorous physical activities every week, but less than 20 minutes a day or 3 days a week.~Active:~I do 30 minutes or more a day of moderate physical activities, 5 or more days a week.~I do 20 minutes or more a day of vigorous physical activities, 3 or more days a week."|Month 6||||units on a scale||Full Range|Median
2561539|NCT02648646|Secondary|Rapid Assessment of Physical Activity: Aerobic Score|"Participants are asked to identify from a list of 7 items which one accurately describes their current level of aerobic physical activity. Participants who identify with items 6 or 7 are considered active. Those who identify with items 1-5 are considered to have suboptimal aerobic physical activity levels.~Sedentary:~I rarely or never do any physical activities.~Under-active:~I do some light or moderate physical activities, but not every week.~Under-active regular - light activities:~I do some light physical activity every week.~Under-active regular:~I do moderate physical activities every week, but less than 30 minutes a day or 5 days a week.~I do vigorous physical activities every week, but less than 20 minutes a day or 3 days a week.~Active:~I do 30 minutes or more a day of moderate physical activities, 5 or more days a week.~I do 20 minutes or more a day of vigorous physical activities, 3 or more days a week."|Week 8||||units on a scale||Full Range|Median
2561540|NCT02648646|Secondary|Activities-specific Balance Confidence Scale|Participant reports level of confidence in doing an activity without losing balance or becoming unsteady on a scale of 0-100%. The ratings are totaled and divided by 16 (the number of items) to calculate a total score.|Month 6||||percentage of confidence||Full Range|Median
2561541|NCT02648646|Secondary|Activities-specific Balance Confidence Scale|Participant reports level of confidence in doing an activity without losing balance or becoming unsteady on a scale of 0-100%. The ratings are totaled and divided by 16 (the number of items) to calculate a total score.|Week 8||||percentage of confidence||Full Range|Median
2561542|NCT02648646|Secondary|Western Ontario and McMaster Universities Osteoarthritis Index|This questionnaire include 5 questions about knee or hip pain, 2 questions about knee or hip stiffness, and 17 questions about difficulty with performing daily activities that involve the lower body. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). A total score is calculated by summing the item scores and ranges from 0 (no problems) to 96 (extreme problems).|Month 6||||units on a scale||Full Range|Median
2561543|NCT02648646|Secondary|Western Ontario and McMaster Universities Osteoarthritis Index|This questionnaire include 5 questions about knee or hip pain, 2 questions about knee or hip stiffness, and 17 questions about difficulty with performing daily activities that involve the lower body. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). A total score is calculated by summing the item scores and ranges from 0 (no problems) to 96 (extreme problems).|Week 8||||units on a scale||Full Range|Median
2561544|NCT02648646|Secondary|Stair Climb Test|Participant ascends and descends 3 stairs as quickly as possible in a safe manner, using handrail and walking aid if needed. Time to complete task is recorded in seconds.|Month 6||||seconds||Full Range|Median
2561545|NCT02648646|Secondary|Stair Climb Test|Participant ascends and descends 3 stairs as quickly as possible in a safe manner, using handrail and walking aid if needed. Time to complete task is recorded in seconds.|Week 8||||seconds||Full Range|Median
2561546|NCT02648646|Secondary|Timed Up and Go Test|Participant stands up from chair, walks 3 meters, turns around, walks back to chair, and sits down. Time to complete task is recorded in seconds.|Month 6||||seconds||Full Range|Median
2561547|NCT02648646|Secondary|Timed Up and Go Test|Participant stands up from chair, walks 3 meters, turns around, walks back to chair, and sits down. Time to complete task is recorded in seconds.|Week 8||||seconds||Full Range|Median
2561555|NCT02648646|Secondary|Four-tests Balance: One Leg Stand|Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.|Month 6||||seconds||Full Range|Median
2561556|NCT02648646|Secondary|Four-tests Balance: One Leg Stand|Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.|Week 8||||seconds||Full Range|Median
2561557|NCT02648646|Secondary|Four-tests Balance: One Leg Stand|Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.|Baseline||||seconds||Full Range|Median
2561558|NCT02648646|Secondary|Four-tests Balance: Tandem Stand|Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.|Month 6||||seconds||Full Range|Median
2561559|NCT02648646|Secondary|Four-tests Balance: Tandem Stand|Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.|Week 8||||seconds||Full Range|Median
2561560|NCT02648646|Secondary|Four-tests Balance: Tandem Stand|Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.|Baseline||||seconds||Full Range|Median
2561561|NCT02648646|Secondary|Four-tests Balance: Semi-tandem Stand|Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.|Month 6||||seconds||Full Range|Median
2561562|NCT02648646|Secondary|Four-tests Balance: Semi-tandem Stand|Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.|Week 8||||seconds||Full Range|Median
2561563|NCT02648646|Secondary|Four-tests Balance: Semi-tandem Stand|Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.|Baseline||||seconds||Full Range|Median
2561564|NCT02648646|Secondary|Four-tests Balance: Feet Together Stand|Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.|Month 6||||seconds||Full Range|Median
2561565|NCT02648646|Secondary|Four-tests Balance: Feet Together Stand|Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.|Week 8||||seconds||Full Range|Median
2561566|NCT02648646|Secondary|Berg Balance Scale|This is 14 item scale that measures balance among older adults. The participant attempts to complete 14 different balance tests (e.g., stand unsupported with eyes closed, pick up object from floor from standing position), closely supervised by a physical therapist to prevent fall or injury. The test takes no more than 15 minutes to complete and a total score is calculated of 0-56 (high fall risk to low fall risk).|Month 6||||units on a scale||Full Range|Median
2561628|NCT02648022|Secondary|Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80%|Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.|up to 24 weeks||||percentage of participants|||Number
2561567|NCT02648646|Secondary|Berg Balance Scale|This is 14 item scale that measures balance among older adults. The participant attempts to complete 14 different balance tests (e.g., stand unsupported with eyes closed, pick up object from floor from standing position), closely supervised by a physical therapist to prevent fall or injury. The test takes no more than 15 minutes to complete and a total score is calculated of 0-56 (high fall risk to low fall risk).|Week 8||||units on a scale||Full Range|Median
2561568|NCT02648646|Secondary|Rapid Assessment of Physical Activity: Aerobic Score|"Participants are asked to identify from a list of 7 items which one accurately describes their current level of aerobic physical activity. Participants who identify with items 6 or 7 are considered active. Those who identify with items 1-5 are considered to have suboptimal aerobic physical activity levels.~Sedentary:~I rarely or never do any physical activities.~Under-active:~I do some light or moderate physical activities, but not every week.~Under-active regular - light activities:~I do some light physical activity every week.~Under-active regular:~I do moderate physical activities every week, but less than 30 minutes a day or 5 days a week.~I do vigorous physical activities every week, but less than 20 minutes a day or 3 days a week.~Active:~I do 30 minutes or more a day of moderate physical activities, 5 or more days a week.~I do 20 minutes or more a day of vigorous physical activities, 3 or more days a week."|Baseline||||units on a scale||Full Range|Median
2561569|NCT02648646|Secondary|Activities-specific Balance Confidence Scale|Participant reports level of confidence in doing an activity without losing balance or becoming unsteady on a scale of 0-100%. The ratings are totaled and divided by 16 (the number of items) to calculate a total score.|Baseline||||percentage of confidence||Full Range|Median
2561570|NCT02648646|Secondary|Western Ontario and McMaster Universities Osteoarthritis Index|This questionnaire include 5 questions about knee or hip pain, 2 questions about knee or hip stiffness, and 17 questions about difficulty with performing daily activities that involve the lower body. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). A total score is calculated by summing the item scores and ranges from 0 (no problems) to 96 (extreme problems).|Baseline||||units on a scale||Full Range|Median
2561571|NCT02648646|Secondary|Stair Climb Test|Participant ascends and descends 3 stairs as quickly as possible in a safe manner, using handrail and walking aid if needed. Time to complete task is recorded in seconds.|Baseline||||seconds||Full Range|Median
2561572|NCT02648646|Secondary|Timed Up and Go Test|Participant stands up from chair, walks 3 meters, turns around, walks back to chair, and sits down. Time to complete task is recorded in seconds.|Baseline||||seconds||Full Range|Median
2561573|NCT02648646|Secondary|30-second Chair Stand Test|Participant rises from chair to full standing position and sits back down as quickly as possible for 30 seconds. Number of completed sit to stand to sit maneuvers is recorded.|Baseline||||completed maneuvers||Full Range|Median
2561574|NCT02648646|Secondary|Hand Grip Dynamometry Right Hand|Participant squeezes hand dynamometer with maximum strength, and force is recorded in kgs.|Baseline||||kilograms||Full Range|Median
2561575|NCT02648646|Secondary|Four-tests Balance: Feet Together Stand|Four timed static balance tasks of increasing difficulty are completed without assistive devices: 1) feet together stand for up to 10 seconds; 2) semi-tandem stand (heel of one foot placed to the side of the big toe of the other foot) for up to 10 seconds; 3) tandem stand (one foot in front of the other, heel touching toe) for up to 10 seconds; and 4) one leg stand for up to 30 seconds. Time for each test is recorded in seconds. If the participant cannot achieve a task, this is recorded as 0 seconds.|Baseline||||seconds||Full Range|Median
2561576|NCT02648646|Secondary|Berg Balance Scale|This is 14 item scale that measures balance among older adults. The participant attempts to complete 14 different balance tests (e.g., stand unsupported with eyes closed, pick up object from floor from standing position), closely supervised by a physical therapist to prevent fall or injury. The test takes no more than 15 minutes to complete and a total score is calculated of 0-56 (high fall risk to low fall risk).|Baseline||||units on a scale||Full Range|Median
2561577|NCT02648646|Secondary|Number of People With Severe of Falls|Participant will record whether the fall resulted in an injury and the type of injury that occurred. A fall will be considered severe if an injury occurred.|Baseline to Month 6||||Participants|||Count of Participants
2561578|NCT02648646|Secondary|Number of Falls|Participant will record occurrence of falls on a monthly falls calendar. Number of falls over the 6 month program will be calculated.|Baseline to Month 6||||falls|||Number
2561579|NCT02648646|Primary|Acceptability of the Program|Descriptive summary of participants' reports from closing interview of what they like and do not like about the program, any challenges they experienced with doing the program, and whether they plan to continue what they learned.|6 months||||Participants|||Count of Participants
2561580|NCT02648646|Primary|Retention of Participants|Number of participants who participate in the study for the full 6 month program.|6 months||||Participants|||Count of Participants
2561581|NCT02648646|Primary|Participant Safety With the Intervention|Number and type of adverse events related to the intervention.|6 months|8 participants completed the 6-month intervention|||adverse events|||Number
2561582|NCT02648646|Primary|Participant Adherence to Intervention|Number of participants who adhere to the intervention.|6 months|8 participants completed the 6-month intervention|||Participants|||Count of Participants
2561583|NCT02648438|Secondary|Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.|||(h*pmol/L)||Geometric Coefficient of Variation|Geometric Mean
2561630|NCT02648022|Primary|Sustained Viral Response (SVR)|The primary outcome for the study was the proportion of patients that achieve an SVR. Patient adherence to completing the prescribed therapy and SVR were both tracked with medical records. Viral load at 4, 12-and 24-weeks during treatment initiation have been shown to predict final SVR. Final SVR data consists of viral tests conducted at 6 months after the termination of therapy.|up to 24 weeks||||percentage of Participants|||Number
2561584|NCT02648438|Secondary|Oral Bioavailability After Inhaled Treatment (F Oral)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.|||Percentage||Geometric Coefficient of Variation|Geometric Mean
2561585|NCT02648438|Secondary|Absolute Systemic Bioavailability After Inhalation (F Inhalation, Total)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.|||Percentage||Geometric Coefficient of Variation|Geometric Mean
2561586|NCT02648438|Secondary|Area Under the Plasma Concentration-curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.|||(h*pmol/L)||Geometric Coefficient of Variation|Geometric Mean
2561587|NCT02648438|Secondary|Observed Maximum Plasma Concentration (Cmax)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2561588|NCT02648438|Secondary|PK of AZD7594 Following Oral Administration by Assessment of the Absolute Systemic Bioavailability After Oral Administration (Fpo)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.|||Percentage||Geometric Coefficient of Variation|Geometric Mean
2561589|NCT02648438|Primary|Pharmacokinetics (PK) of AZD7594 Delivered by Monodose Inhaler and Multiple-dose DPI or pMDI in Terms of Pulmonary Bioavailability After Inhalation (Fpulmonary)|For oral and inhalation administrations: pre-dose (0 hour) and post-dose at 15, 30 and 45 minutes and 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 24.0, 36.0, 48.0, 72.0 and 96.0 hours following the administration of the investigational product AZD7594. For IV administration: pre-dose (0 hour) and post-dose at 5, 10, 15 (end of infusion), 30, 45, 60 and 90 minutes and 2.0, 4.0, 6.0, 8.0, 12.0, 16.0, 48.0, 72.0 and 96.0 hours following the start of the IV infusion of the investigational product AZD7594|0-96 hours|The PK analysis set will consist of all subjects in the safety analysis set for whom at least 1 PK parameters can be calculated for at least 1 treatment period and who have no major protocol deviations thought to impact on the analysis of the PK data.|||Percentage||Geometric Coefficient of Variation|Geometric Mean
2561590|NCT02648230|Primary|Mean Fractional Flow Reserve (FFR)|The mean FFR will be measured with the pressure catheter (PC) to be compared against the mean FFR measured with a standard Pressure Wire (PW) within the same subject across the same target lesion at the same time. Fractional flow reserve measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum flow in a normal coronary artery.|Through study completion (an average of an hour)||||ratio||Inter-Quartile Range|Mean
2561591|NCT02648217|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes|"Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes, which occurred between 00:01 and 05:59 both inclusive.~Novo Nordisk definition; severe or blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that was severe according to ADA classification or BG confirmed by a plasma glucose (PG) value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.~Severe hypoglycaemia as per ADA classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration."|From week 0 to 4 weeks post Ramadan|Analysis was based on the SAS, which included all subjects receiving at least one dose of the investigational product or its comparator.|||Number of episodes.|||Number
2561661|NCT02647658|Secondary|Number of Patients Who Had Back Surgery|Documentation that patient underwent back surgery in electronic health records|12 months|All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.|||Participants|||Count of Participants
2561592|NCT02648217|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes Both According to the Novo Nordisk Definition for Hypoglycaemic Episodes (Severe or BG Hypoglycaemia) as Well as According to the ADA definition1 Confirmed Symptomatic|"Treatment-emergent hypoglycaemic episodes: If the onset of the episode occurred on or after the first day of investigational medicinal product (IMP; IDegAsp/BIAsp 30) administration, and no later than 1 day after the last day on IMP, before switching to or being treated with another insulin product.~The above mentioned definitions (in endpoint title) should read as the following:~Novo Nordisk definition; severe or blood glucose (BG) confirmed symptomatic hypoglycaemia: An episode that was severe according to ADA classification or BG confirmed by a plasma glucose (PG) value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.~American Diabetes Association (ADA) definition; documented symptomatic hypoglycaemia: An episode, during which typical symptoms of hypoglycaemia were accompanied by a measured PG concentration ≤3.9 mmol/L (70 mg/dL).~Due to character limitation, severe hypoglycaemia as per ADA classification is not defined here; see next outcome measure."|From week 0 to 4 weeks post Ramadan|Analysis was based on the safety analysis set (SAS), which included all subjects receiving at least 1 dose of the investigational product (IDegAsp) or its comparator (BIAsp 30).|||Number of episodes.|||Number
2561593|NCT02648217|Secondary|Number of Subjects Who Achieve FPG Below or Equal to 7.2 mmol/L (ADA Target)|Number of subjects who achieved FPG <=7.2 mmol/L at the end of Ramadan (day 29 of Ramadan). The above written (in the endpoint title) 'ADA target' is not applicable for FPG.|End of Ramadan (day 29 of Ramadan)|Analysis was based on the FAS, which included all randomised subjects. Here, ‘number of subjects analysed’ specifies the number of subjects with available data at specified time-point.|||Number of subjects.|||Number
2561594|NCT02648217|Secondary|Number of Subjects Who Achieve HbA1c Below 7% (53 mmol/Mol (American Diabetes Association (ADA) Target )|Number of subjects who achieved HbA1c below 7% (53 mmol/mol; ADA target) at the end of Ramadan (day 29 of Ramadan).|End of Ramadan (day 29 of Ramadan)|Analysis was based on the FAS, which included all randomised subjects. Here, ‘number of subjects analysed’ specifies the number of subjects with available data at specified time-point.|||Number of subjects|||Number
2561595|NCT02648217|Secondary|Change in Fructosamine|Mean change in fructosamine was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan).|From week 0 to end of Ramadan (day 29 of Ramadan)|Analysis was based on the FAS, which included all randomised subjects. Here, ‘number of subjects analysed’ specifies the number of subjects with available data at specified time-point.|||mmol/L||Standard Deviation|Mean
2561596|NCT02648217|Secondary|Change in Fasting Plasma Glucose (FPG)|Mean change in FPG was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan).|From week 0 to end of Ramadan (day 29 of Ramadan)|Analysis was based on the FAS, which included all randomised subjects. Here, ‘number of subjects analysed’ specifies the number of subjects with available data at specified time-point.|||mmol/L||Standard Deviation|Mean
2561597|NCT02648217|Primary|Change in HbA1c (%) (Glycosylated Haemoglobin)|Mean change in HbA1c was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan).|From week 0 to end of Ramadan (day 29 of Ramadan)|Here, ‘number of subjects analysed’ specifies the number of subjects, who contributed to the analysis.|||Percentage (%) of HbA1c||Standard Error|Least Squares Mean
2561598|NCT02648204|Secondary|Change in Pulse Rate|Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 40|Analysis was based on safety analysis set.|||beats/min||Standard Error|Least Squares Mean
2561599|NCT02648204|Secondary|Change in Lipase|Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.|Week 0, week 40|Analysis was based on safety analysis set. Number of participants analysed=number of participants with available data for lipase.|||ratio to baseline||Standard Error|Geometric Least Squares Mean
2561600|NCT02648204|Secondary|Change in Amylase|Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.|Week 0, week 40|Analysis was based on safety analysis set. Number of participants analysed=number of participants with available data for amylase.|||ratio to baseline||Standard Error|Geometric Least Squares Mean
2561662|NCT02647658|Secondary|Number of Patients Undergoing Interventional Pain Procedures|Receipt of interventional pain procedures including epidural steroid injections measured using electronic health records|12 months|All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.|||Participants|||Count of Participants
2561601|NCT02648204|Secondary|Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes|Percentage of subjects with treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|40 weeks + follow-up of 5 weeks|Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product.|||percentage of subjects|||Number
2561602|NCT02648204|Secondary|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemia Episodes|A treatment emergent hypoglycaemic episode was defined as an episode with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days). Severe or BG-confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association classification or BG-confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|40 weeks + follow-up of 5 weeks|Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product.|||hypoglycaemic episodes|||Number
2561603|NCT02648204|Secondary|Number of Treatment Emergent Adverse Events (TEAEs)|A TEAE was defined as an AE with onset in the 'on-treatment' period (information collected while subjects were considered as exposed to trial product). This corresponded to information collected until the follow-up (5 weeks after the last treatment including a visit window of +7 days).|40 weeks + follow-up of 5 weeks|Analysis was based on the safety analysis set which included all randomised subjects exposed to at least one dose of trial product.|||events|||Number
2561604|NCT02648204|Secondary|Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1% and Weight Loss ≥3%|Percentage of subjects who achieved (yes/no) HbA1c reduction ≥1% and weight loss ≥3% 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|After 40 weeks treatment|Analysis was based on FAS. Number of participants analysed=number of participants with available data for HbA1c and body weight.|||percentage of subjects|||Number
2561605|NCT02648204|Secondary|Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥3%|Percentage of subjects who achieved (yes/no) weight loss of ≥3% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|After 40 weeks treatment|Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight|||percentage of subjects|||Number
2561606|NCT02648204|Secondary|Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c Reduction ≥1%|Percentage of subjects who achieved (yes/no) HbA1c reduction of ≥1% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|After 40 weeks of treatment|Analysis was based on FAS.|||percentage of subjects|||Number
2561607|NCT02648204|Secondary|Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain|Percentage of subjects achieved (yes/no) HbA1c <7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was subset of 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit|After 40 weeks of treatment|Analysis was based on FAS. Number of participants analysed=number of participants with available data for this endpoint.|||percentage of subjects|||Number
2561866|NCT02643979|Secondary|Total Sedation Required to Allow Initiation of Procedure|Using the computerized record system, the amount of Propofol a patient required to allow for the procedure to start quantified and compared between groups.|Day 1||||mg/kg||Standard Deviation|Mean
2561608|NCT02648204|Secondary|Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥10%|Percentage of subjects who achieved weight loss ≥10% after 40 weeks of treatment. Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|After 40 weeks treatment|Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight|||percentage of subjects|||Number
2561609|NCT02648204|Secondary|Subjects Who After 40 Weeks Treatment Achieve (Yes/no) Weight Loss ≥5%|Percentage of subjects who achieved weight loss ≥5% after 40 weeks of treatment. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|After 40 weeks treatment|Analysis was based on FAS. Number of participants analysed=number of participants with available data for body weight.|||percentage of subjects|||Number
2561610|NCT02648204|Secondary|Subjects Who After 40 Weeks Treatment Achieve (Yes/no) HbA1c <7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target|Percentage of subjects who achieved HbA1c target below or equal to <7.0% (53 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|After 40 weeks of treatment|Analysis was based on FAS.|||percentage of subjects|||Number
2561611|NCT02648204|Secondary|Change in Short Form Health Survey (SF-36v2™)|The questionnaire contains 36 items across 8 domains and 2 summary scores. Score range: 0 (worst score) to 100 (best score). Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 40|Analysis was based on FAS. Number analysed=number of participants with available data for SF-36.|||units on a scale||Standard Error|Least Squares Mean
2561612|NCT02648204|Secondary|Change in Waist Circumference|Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=number of participants with available data for waist circumference.|||cm||Standard Error|Least Squares Mean
2561613|NCT02648204|Secondary|Change in Body Mass Index (BMI)|Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=number of participants with available data for BMI.|||kg/m^2||Standard Error|Least Squares Mean
2561629|NCT02648022|Secondary|Percentage of Participants With Treatment Initiation and Completion|The main secondary outcomes for the study include rates of Interferon-based treatment initiation and completion. Treatment data from the HCV clinics were reviewed for each patient at each site. Participants who a) filled at least one prescription for Interferon and ribavirin, and b) had at least one treatment-related physician visit with a medical record note stating they began taking the medications were deemed to have initiated antiviral treatment. Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.|up to 24 weeks||||percentage of Particpants|||Number
2561614|NCT02648204|Secondary|Change in Fasting Blood Lipids (Triglycerides)|Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=number of participants with available data for triglycerides.|||ratio to baseline||Standard Error|Geometric Least Squares Mean
2561615|NCT02648204|Secondary|Change in Fasting Blood Lipids (High Density Lipoprotein [HDL] Cholesterol)|Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=number of participants with available data for HDL cholesterol.|||ratio to baseline||Standard Error|Geometric Least Squares Mean
2561616|NCT02648204|Secondary|Change in Fasting Blood Lipids (Low Density Lipoprotein [LDL] Cholesterol)|Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=number of participants with available data for LDL cholesterol.|||ratio to baseline||Standard Error|Geometric Least Squares Mean
2561617|NCT02648204|Secondary|Change in Fasting Blood Lipids (Total Cholesterol)|Results are based on the data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit. Change from baseline is presented in terms of ratio to baseline value.|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=number of participants with available data for total cholesterol|||ratio to baseline||Standard Error|Geometric Least Squares Mean
2561618|NCT02648204|Secondary|Change From Baseline 7-point Self-measured Plasma Glucose Increment|SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are plasma glucose incremental profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=number of participants with available data for 7-point self-measured plasma glucose increment.|||mmol/L||Standard Error|Least Squares Mean
2561619|NCT02648204|Secondary|Change From Baseline in 7-point Self-measured Plasma Glucose (SMPG) Mean Profile|SMPG values were recorded at 7 time-points: before and 90 minutes after start of breakfast, lunch, and dinner, and at bedtime. Reported results are mean profile from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=Number of participants analysed=number of participants with available data for 7-point self-measured plasma glucose.|||mmol/L||Standard Error|Least Squares Mean
2562103|NCT02641561|Secondary|The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)|> 10% immature neutrophils (band forms).|30 days after ERCP||||Participants|||Count of Participants
2561620|NCT02648204|Secondary|HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target|Percentage of subjects who achieved HbA1c target below or equal to 6.5% (48 mmol/mol) after 40 weeks of treatment. Results are based on data from on-treatment without rescue medication period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. Missing data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|After 40 weeks treatment|Results are based on the FAS.|||percentage of subjects|||Number
2561621|NCT02648204|Secondary|Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire|The questionnaire contains 8 items and evaluates subjects' diabetes treatment in terms of convenience, flexibility and general feelings towards treatment. The result presented is 'Treatment Satisfaction' summary score (sum of 6 of the 8 items). Response options: 6 (best case) to 0 (worst case). Total scores range: 0-36. Higher scores=higher satisfaction. Results are based on data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was period where subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This includes observations recorded at, or after the date of first dose of trial product and not after first occurrence of following: the end-date of the 'on-treatment' observation period or initiation of rescue medication|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=number of participants with available data for diabetes treatment satisfaction questionnaire|||units on a scale||Standard Error|Least Squares Mean
2561622|NCT02648204|Secondary|Change in Systolic and Diastolic Blood Pressure|Results are based on systolic and diastolic blood pressure data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.|Week 0, week 40|Analysis was based on FAS.|||mmHg||Standard Error|Least Squares Mean
2561623|NCT02648204|Secondary|Change in Fasting Plasma Glucose|Results are based on fasting plasma glucose data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.|Week 0, week 40|Analysis was based on FAS. Number of participants analysed=number of participants with available data for fasting plasma glucose.|||mmol/L||Standard Error|Least Squares Mean
2561624|NCT02648204|Secondary|Change in Body Weight (kg)|Results are based on body weight data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on -treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication.|Week 0, week 40|Analysis was based on FAS. Number of subjects analysed=number of subjects with available data for body weight.|||kg||Standard Error|Least Squares Mean
2561625|NCT02648204|Primary|Change in HbA1c|Results are based on HbA1c data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on-treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 40|Analysis was based on FAS.|||percentage of HbA1c||Standard Error|Least Squares Mean
2561626|NCT02648178|Primary|Average Number of E-cigarettes Used Per Day|Average number of e-cigarettes used per day over the 12 week period|12 Weeks||||ecig sessions per day||95% Confidence Interval|Mean
2561627|NCT02648178|Primary|Change in Daily Cigarette Smoking Given 10 or More E-cigarette Sessions in a Day|Participants report of daily cigarette and e-cigarette use for the previous 7 days at each study time-point (baseline and 3, 6, 9, and 12 weeks post-baseline) will be averaged to create usual daily cigarette. Mixed-effects linear regression with a random effect at the participant level will be used to assess the association between usual cigarette use (dependent variable) and usually e-cigarette use (independent predictor) over the study period while accounting for the repeated measures within subject. The model will be fit using restricted maximum likelihood. Time will be included in the model as continuous and categorical, separately, and we assess for stability of the association between cigarette use and e-cigarette over time by including an interaction term between e-cigarette use and time in the model.|12 Weeks||||number of Daily Cigarettes||95% Confidence Interval|Mean
2561914|NCT02643004|Secondary|Lens Surface - Wettability|Lens wettability for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|1 week|A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.|||percentage of subjects|||Number
2561631|NCT02647944|Secondary|Gastric Accommodation Volume at 16 Weeks|Change between postprandial and fasting whole gastric volume by 99mTc-SPECT Imaging. A noninvasive SPECT method was used to measure gastric volume during fasting and 32 min after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication was given s.c. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans were obtained. Each scan required 9-12 min. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content.|16 weeks (approximately 1 hour after 99mTC injection)|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||mL||Inter-Quartile Range|Median
2561632|NCT02647944|Secondary|Gastric Postprandial Volume at 16 Weeks|Gastric fasting volume was measured by single photon emission computed tomography (SPECT) imaging of the stomach after intravenous injection of 99mTC-pertechnetate, which is taken up by the gastric mucosa.|16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||mL||Inter-Quartile Range|Median
2561633|NCT02647944|Secondary|Gastric Fasting Volume at 16 Weeks|Gastric fasting volume was measured by single photon emission computed tomography (SPECT) imaging of the stomach after intravenous injection of 99mTC-pertechnetate, which is taken up by the gastric mucosa.|16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||mL||Inter-Quartile Range|Median
2561634|NCT02647944|Secondary|Satiation Maximum Tolerated Volume at 16 Weeks|After drinking Ensure, participants recorded their sensations every 5 minutes using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation).|16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||mL||Inter-Quartile Range|Median
2561635|NCT02647944|Secondary|Satiation Volume to Fullness at 16 Weeks|After drinking Ensure, participants recorded their sensations every 5 minutes using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation).|16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||mL||Inter-Quartile Range|Median
2561636|NCT02647944|Secondary|Satiety by Buffet Meal, Total Calories Ingested at 16 Weeks|"Satiety (a measure of appetite) was appraised by free feeding buffet meal consisting of standard foods of known nutrient composition. The total amount of food consumed was analyzed by the study dietitian."|16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||kcal||Inter-Quartile Range|Median
2561637|NCT02647944|Secondary|Weight Change at 16 Weeks|Body weight in kg was measured at 16 weeks and compared to baseline.|baseline, 16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||kg||Inter-Quartile Range|Median
2561638|NCT02647944|Secondary|Weight Change at 5 Weeks|Body weight in kg was measured at 5 weeks and compared to baseline.|baseline, 5 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||kg||Inter-Quartile Range|Median
2561639|NCT02647944|Primary|Gastric Emptying of Solids Half-time (T1/2) at 16 Weeks|Gastric emptying of solids was assessed by scintigraphy using a 320 Kcal 99mTc-radiolabeled egg, solid-liquid meal. Gastric Emptying Half-time was the linear interpretation of time to when 50% of radiolabeled meal emptied from the stomach.|16 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||minutes||Inter-Quartile Range|Median
2561640|NCT02647944|Primary|Gastric Emptying of Solids Half-time (T1/2) at 5 Weeks|Gastric emptying of solids was assessed by scintigraphy using a 320 Kcal 99mTc-radiolabeled egg, solid-liquid meal. Gastric Emptying Half-time was the linear interpretation of time to when 50% of radiolabeled meal emptied from the stomach.|5 weeks|Intent to treat analysis; data were imputed for the 5 participants who dropped out.|||minutes||Inter-Quartile Range|Median
2561641|NCT02647905|Other Pre-specified|CGM System Agreement With Reference Control|The percentage of system readings within ±15 mg/dL or 15% of YSI reference values (15/15%)|90 days||||percent of readings within 15/15%|||Number
2561642|NCT02647905|Primary|CGM Relative Difference to Laboratory Reference Reported as MARD|Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 90 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison.|90 days||||percent||95% Confidence Interval|Mean
2561643|NCT02647866|Secondary|Number of Subjects Who Achieve Clinical Remission at Week 52|The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical remission is defined as a total Mayo Clinic score of ≤ 2 and no subscores > 1.|52 weeks||||Participants|||Count of Participants
2561644|NCT02647866|Secondary|Number of Subjects Who Achieve Clinical Remission at Week 12|The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical remission is defined as a total Mayo Clinic score of ≤ 2 and no subscores > 1.|12 weeks||||Participants|||Count of Participants
2561645|NCT02647866|Secondary|Number of Subjects Who Achieve a Clinical Response at Week 52|The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical Response indicates the change from Baseline in the Total Mayo Clinic score <= -3 and the percentage change from Baseline in the Total Mayo Clinic score <= -30% to Week 12, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of <= 1.|52 weeks||||Participants|||Count of Participants
2561663|NCT02647658|Secondary|Number of Patients Referred to Surgery Specialist|Referral to any surgical specialist (orthopaedist, neurosurgeon, anesthesiologist) measured using electronic health records|12 months|All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.|||Participants|||Count of Participants
2561646|NCT02647866|Secondary|Number of Subjects Who Achieve a Clinical Response at Week 12|The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical Response is a reduction in the total Mayo Clinic score of at least 3 points.|12 weeks|Full analysis set - All randomized subjects who received at least one full dose of investigational product and had a Baseline and at least one post-treatment primary efficacy variable.|||Participants|||Count of Participants
2561647|NCT02647866|Secondary|Change From Baseline in Total Mayo Scale Score at Week 52|The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Improvement was based on a reduction (mean change from Baseline [Week 0] to Week 52) in the total Mayo Clinic score.|52 weeks|"The overall number of participants is the number in the full analysis set. The number of patients analyzed is the number of patients who had values at the noted visits.~There were no subjects in the 10.0 mg/kg KHK4083 group in the LTE Therapy Period. There were no subjects in the 1.0 mg/kg KHK4083 group in the OLE Therapy Period."|||score on a scale||Standard Deviation|Mean
2561648|NCT02647866|Secondary|Number of Subjects Who Achieve Clinical Improvement at Week 12|The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Improvement will be based on a reduction in the total Mayo Clinic score.|12 weeks|Full analysis set - All randomized subjects who received at least one full dose of investigational product and had a Baseline and at least one post-treatment primary efficacy variable.|||Participants|||Count of Participants
2561649|NCT02647866|Secondary|Number of Subjects Who Achieve Mucosal Healing at Week 52|The endoscopic Mayo Score (Mayo endoscopic subscore) evaluates ulcerative colitis stage, based only on endoscopic exploration. The scale ranges from 0 to 3, with higher scores = more severe activity. Mucosal healing is defined as modified Mayo endoscopy sub-score (mMES) of 0 or 1.|52 weeks||||Participants|||Count of Participants
2561650|NCT02647866|Secondary|Number of Subjects Who Achieve Mucosal Healing at Week 12|The endoscopic Mayo Score (Mayo endoscopic subscore) evaluates ulcerative colitis stage, based only on endoscopic exploration. The scale ranges from 0 to 3, with higher scores = more severe activity. Mucosal healing is defined as modified Mayo endoscopy sub-score (mMES) of 0 or 1 at Week 12.|12 weeks|Full analysis set - All randomized subjects who received at least one full dose of investigational product and had a Baseline and at least one post-treatment primary efficacy variable.|||Participants|||Count of Participants
2561651|NCT02647866|Secondary|Number of Subjects With Confirmed Anti-KHK4083 Antibodies (Immunogenicity)|The immunogenicity was assessed by determination of the development of anti-drug antibodies (ADA) against KHK4083.|52 weeks|All subjects who received at least one dose of KHK4083, including 14 subjects initially randomized to placebo and who then continued into Open-Label Extension therapy, where they received the maximum tolerated dose of KHK4083.|||Participants|||Count of Participants
2561652|NCT02647866|Primary|Proportion of Subjects Who Show Improvement in the Mucosa at Week 52|Measured by the modified Mayo endoscopy sub-score (mMES), which ranges from 0-3 with higher scores = more severe disease.|52 weeks||||Participants|||Count of Participants
2561653|NCT02647866|Primary|Number of Subjects Who Show Improvement in the Mucosa at Week 12|Measured by the modified Mayo endoscopy sub-score (mMES), which ranges from 0-3 with higher scores = more severe disease.|12 weeks|Full analysis set - All randomized subjects who received at least one full dose of investigational product and had a Baseline and at least one post-treatment primary efficacy variable.|||Participants|||Count of Participants
2561654|NCT02647866|Primary|Number of Subjects With Treatment-related Serious Adverse Events|To determine the safety and tolerability of KHK4083|Up to 52 weeks|Safety Analysis Set - All randomized subjects who received any (even partial dose) investigational product (KHK4083 or placebo).|||Participants|||Count of Participants
2561655|NCT02647866|Primary|Number of Subjects With Treatment-related Adverse Events|To determine the safety and tolerability of KHK4083|Up to 52 weeks|Safety Analysis Set - All randomized subjects who received any (even partial dose) investigational product (KHK4083 or placebo).|||Participants|||Count of Participants
2561656|NCT02647788|Secondary|Number of Pills Used||From the time of surgery to first clinic visit (post-op day 6 to 8)|Of the 111 subjects that completed the study, data about how many capsules were used was available for 100 participants.|||Pills||Standard Deviation|Mean
2561657|NCT02647788|Secondary|Quality of Recovery-9 (QoR-9).|To establish whether the opioid versus non-opioid post-operative pain regimen influences patient satisfaction through Quality of Recovery (QoR) scores in ambulatory hand surgery. This 9 question survey has a maximum score (best outcome) of 18 and minimum (worst outcome) of 3. The survey was administered over the phone on post-operative day 2.|Postoperative Day 2|Of the 111 subjects that completed the study, QoR score was available for 93 participants.|||Scores on a scale||Standard Deviation|Mean
2561658|NCT02647788|Primary|Assessing Change in Pain Using the Visual Analogue Scale (VAS) Pain Score|To establish, through a randomized control trial, whether post-operative Acetaminophen and Ibuprofen (non-opioid regimen) would provide equivalent post-operative analgesia to ambulatory hand surgery patients compared to Acetaminophen and Codeine (opioid regimen). The pain VAS is a continuous scale where 0=no pain and 10=worst pain imaginable.|Subjects reported pain 3 times a day each day after hand surgery (at dinner time, before going to sleep and in the middle of the night), until post-op appointment (between 4 and 8 days after surgery). The numbers reported are the average daily pain scores|111 patients completed the study and their data was included in the analysis|||score on a scale||Standard Deviation|Mean
2561659|NCT02647658|Other Pre-specified|Number of Patients Referred to Physical Therapy|Patient referred to physical therapy or psychologically informed physical therapy measured using electronic health records at the index baseline visit. This is a measure of intervention fidelity post-randomization of the clinics.|Up to 21 days after initial visit for acute low back pain||||Participants|||Count of Participants
2561660|NCT02647658|Other Pre-specified|Number of Patients Prescribed Opioids|Medication prescription for opioids measured using electronic health records at the index baseline visit for the patient. Measure of intervention fidelity post clinic randomization.|Up to 21 days after initial visit for acute low back pain||||Participants|||Count of Participants
2561664|NCT02647658|Secondary|Number of Patients Referred to Other Rehabilitation or Pain Management Specialist|Referral to any non-physical therapy rehabilitation or pain management specialist (chiropractic, physiatrist, pain management) measured using electronic health records|12 months|All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.|||Participants|||Count of Participants
2561665|NCT02647658|Secondary|Number of Patients With Orders for Diagnostic Imaging Tests|Referrals for diagnostic imaging (X-rays and MRI) measured using electronic health records|12 months|All screened except participants who did not provide consent for 12 month follow up from EMR from 1 site.|||Participants|||Count of Participants
2561666|NCT02647658|Secondary|Number of Patients Prescribed Opioids|Medication prescription for opioids measured using electronic health records over 12 months.|12 months|All screened excluding patients that did not consent to EMR data at 12 months at 1 site.|||Participants|||Count of Participants
2561667|NCT02647658|Secondary|Number of Patients Referred to Physical Therapy|Patient referred to physical therapy or psychologically informed physical therapy measured using electronic health records over 12 months.|12 months|All screened excluding those not consented for EMR follow up at 12 months at 1 site.|||Participants|||Count of Participants
2561668|NCT02647658|Primary|Functional Disability|"Measured using the 10-item Oswestry Disability Index (version 2.1a). Also known as the Oswestry Low Back Pain Disability Questionnaire.~A measure of a patient's functional disability. The scale ranges from 0% to 100% with higher scores indicating more disability."|6 months|Participants with assessment data at 6 months.|||score on a scale||95% Confidence Interval|Mean
2561669|NCT02647658|Primary|Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP)|Measured using a 2-item Chronic Low Back Pain (LBP) questionnaire. Patient endorses low back pain that interferes with regular daily activities more than 3 months and more then 1/2 the days in the past 6 months.|6 months from baseline|Among participants with assessment data at 6 months|||Participants|||Count of Participants
2561670|NCT02647645|Secondary|Patient's Own Assessment of Function (PAOF)|"Patient report of cognitive difficulties on the Patient Assessment of Own Functioning. This scale comprises 33 items describing problems in thinking, language, and memory. Participants rate each items according to how often they experience each problem on a six-point scale from almost never (score of 0) to almost always (score of 5). The participant's score is the sum of ratings on all items. The range of possible scores on each item is from 0 to 5, with most persons achieving a score of 1.5 or lower. Higher scores represent more frequent report of cognitive difficulties and thus are considered worse. The range of all possible scores for the full scale of 33 items is is 0 to 165."|3 weeks|All participants who completed training.|||Score on a scale||Standard Error|Mean
2561671|NCT02647645|Secondary|Center for Epidemiological Studies Depression Scale (CES-D)|Participants' mood over the course of the study. We used the Center for Epidemiological Studies--Depression scale (CES-D) to measure mood. This measure includes 20 items that ask the person assessed to report his or her experience of mood symptoms over the past two weeks. Participants completed this measure before and after the study intervention. Scores can range from zero to 60, with most persons attaining a score of 15 or less. Higher scores are considered worse as they indicate more frequent or more severe mood symptoms.|3 weeks|All participants who completed the study.|||units on a scale||Standard Error|Mean
2561672|NCT02647645|Primary|Working Memory: Participants' Rate of Improvement|Participants' rate of improvement on a verbal working memory task. Participants completed a battery of cognitive measures administered by an evaluator blind to treatment assignment. We used the Digits Backward trial of the Digit Span subtest of the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV; Pearson Assessment) to measure working memory. We used raw scores for analyses. These are the largest number of digits the participant could remember and repeat in reverse order. Possible range of scores is from zero to 10. Normal persons typically remember from 5 to 7 digits. Higher scores are considered better. Analysis results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, helper T cell count, and log viral load as covariates.|3 weeks|All participants who completed treatment.|||units on a scale||Standard Error|Mean
2561673|NCT02647346|Secondary|Device-related Injuries||Through study completion or subject withdrawal (34 weeks per-protocol)||||occurence|||Number
2561674|NCT02647346|Secondary|Device-related Trips/Falls||Through study completion or subject withdrawal (34 weeks per-protocol)||||occurence|||Number
2561675|NCT02647346|Secondary|Subject Adherence in Daily Use of the Study Device||Through study completion or subject withdrawal (34 weeks per-protocol)||||uses/week||Standard Deviation|Mean
2561676|NCT02647346|Primary|Occurrence of Plantar Diabetic Foot Ulcer||Through study completion or subject withdrawal (34 weeks per-protocol)||||Participants|||Count of Participants
2561677|NCT02647320|Secondary|Count of Participants With HbA1c Less Than 7.0% at Week 12|HbA1C less than 7% is the success goal for many Type 2 diabetics.|Week 12|mITT|||Participants|||Count of Participants
2561678|NCT02647320|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.|Baseline, Week 12|mITT with a measurement at baseline and Week 12|||mg/dL||Standard Deviation|Mean
2561679|NCT02647320|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 8|Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.|Baseline, Week 8|mITT with a measurement at baseline and Week 8|||mg/dL||Standard Deviation|Mean
2561680|NCT02647320|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4|Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.|Baseline, Week 4|mITT with a measurement at baseline and Week 4|||mg/dL||Standard Deviation|Mean
2561867|NCT02643979|Secondary|Total Dose of Propofol Used During the Procedure|Propofol doses are logged in the computerized Compurecord system used in the operating room. Patients involved in the study had their total Propofol dose required quantified and compared between groups who received Ketamine and groups who did not.|Day 1||||mg/kg||Standard Deviation|Mean
2561681|NCT02647320|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 2|Normal fasting plasma glucose -- or blood sugar -- is between 70 and 100 milligrams per deciliter (mg/dL) for people who do not have diabetes. People with Type 2 diabetes typically have FPG that is too high, so a negative change from baseline means improvement.|Baseline, Week 2|mITT with a measurement at baseline and Week 2|||mg/dL||Standard Deviation|Mean
2561682|NCT02647320|Secondary|Change From Baseline in Cmax of PG in Response to MMTT at Week 12|Cmax measures the highest amount of glucose in the blood, so a negative change means improvement.|Baseline, Week 12|mITT with a measurement at baseline and Week 12|||mg/dL||Standard Deviation|Mean
2561683|NCT02647320|Secondary|Change From Baseline in Maximum Concentration (Cmax) of PG in Response to MMTT at Week 4|Cmax measures the highest amount of glucose in the blood, so a negative change means improvement.|Baseline, Week 4|mITT with a measurement at baseline and Week 4|||mg/dL||Standard Deviation|Mean
2561684|NCT02647320|Secondary|Change From Baseline in AUC0-3h of PG in Response to the MMTT at Week 12|"The MMTT requires a participant to drink a mixed meal, such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement."|Baseline, Week 12|mITT with a measurement at baseline and Week 12|||(mg/dL)*hr||Standard Deviation|Mean
2561685|NCT02647320|Secondary|Change From Baseline in Area-Under-the Curve 0-3 Hours (AUC0-3h) of Plasma Glucose (PG) in Response to the Mixed Meal Tolerance Test (MMTT) at Week 4|"The MMTT requires a participant to drink a mixed meal, such as Boost or Ensure, that contains protein, carbohydrates, and fat. The goal of the test is to find out how much insulin the pancreas makes in response to food by measuring the level of glucose in the blood. The lower the level of glucose in the blood during the first three hours after the test (AUC0-3h), the more insulin the body has made in response to the test. This would mean a negative change shows improvement."|Baseline, Week 4|mITT with a measurement at baseline and Week 4|||(mg/dL)*hr||Standard Deviation|Mean
2561686|NCT02647320|Secondary|Change From Baseline in Triglycerides at Week 12|Triglycerides are a type of fat found in the blood. The body uses them for energy. Some triglycerides are needed for good health. But high triglycerides might raise the risk of heart disease. Since Type 2 diabetics tend to have high triglycerides, a negative change means improvement.|Baseline, Week 12|mITT|||percent change in triglycerides||Standard Deviation|Mean
2561687|NCT02647320|Secondary|Change From Baseline in Non-HDL-C at Week 12|"Non-HDL-C is the measure of bad cholesterol in the blood, including triglycerides and LDL-C, so a negative change means improvement. The equation for Non-HDL-C = LDL-C + (triglycerides/5)."|Baseline, Week 12|mITT|||Percent change in Non-HDL-C||Standard Deviation|Mean
2561688|NCT02647320|Secondary|Change From Baseline in HDL-C at Week 12|"HDL-C is known as the good cholesterol, so a higher score (positive change) means improvement."|Baseline, Week 12|mITT|||percent change in HCL-C||Standard Deviation|Mean
2561689|NCT02647320|Secondary|Change From Baseline in LDL-C at Week 12|"LDL-C is known as the bad cholesterol, so a lower score (negative change) means improvement."|Baseline, Week 12|mITT|||percent change in LDL-C||Standard Deviation|Mean
2561690|NCT02647320|Secondary|Change From Baseline in Total Cholesterol (TC) at Week 12|"Total cholesterol is a measure of the total amount of cholesterol in the blood, including low-density lipoprotein cholesterol (LDL-C) - the bad cholesterol, high-density lipoprotein cholesterol (HDL-C) - the good cholesterol, and triglycerides. The equation to calculate total cholesterol is: LDL + HDL + (triglycerides/5) = total cholesterol."|Baseline, Week 12|mITT|||percent change in TC||Standard Deviation|Mean
2561691|NCT02647320|Primary|Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12|Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the three-month average glucose concentration in the blood. Target HbA1c for Type 2 diabetics was less than 7% at the time of this trial. Negative scores show improvement from baseline.|Baseline, Week 12|Modified Intent to Treat (mITT) Set, defined as all participants in the Safety Set who have a baseline measurement and at least 1 post-baseline measurement. mITT was used for analysis because one of the sites had a fire so 16 participants who were included in the baseline population were not included in analyses.|||percent of HbA1c||Standard Deviation|Mean
2561692|NCT02647281|Secondary|Tmax, T1/2 and Tlag of the Metabolite of GSK3389404 Following Dosing on Day 22 of Part 2|Blood samples were collected to evaluate Tmax, T1/2 and Tlag of the metabolite of GSK3389404 on Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 113+- 2 days).|Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)|Pharmacokinetic Concentration Population. Based on emerging PK results during the course of the study, it was observed that metabolite plasma concentrations were not quantifiable in any PK sample. Hence, PK parameters could not be estimated for metabolite.||||||
2561693|NCT02647281|Secondary|Ctau, C24 and Cmax of the Metabolite of GSK3389404 Following Dosing of GSK3389404 on Day 22 of Part 2|Blood samples were collected to evaluate Ctau, C24 and Cmax of the metabolite of GSK3389404 on Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 113+- 2 days).|Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)|Pharmacokinetic Concentration Population. Based on emerging PK results during the course of the study, it was observed that metabolite plasma concentrations were not quantifiable in any PK sample. Hence, PK parameters could not be estimated for metabolite.||||||
2561694|NCT02647281|Secondary|AUC(0-24) and AUC(0-tau) of the Metabolite of GSK3389404 Following Dosing of GSK3389404 on Day 22 of Part 2|Blood samples were collected to evaluate AUC (0-24) and AUC (0-tau) of the metabolite of GSK3389404 on Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 113+- 2 days).|Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)|Pharmacokinetic Concentration Population. Based on emerging PK results during the course of the study, it was observed that metabolite plasma concentrations were not quantifiable in any PK sample. Hence, PK parameters could not be estimated for metabolite.||||||
2561695|NCT02647281|Secondary|Tmax, T1/2 and Tlag of the Metabolite of GSK3389404 Following Single Dose on Day 1 of Part 2|Blood samples were collected to evaluate Tmax, T1/2 and Tlag of the metabolite of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose|Pharmacokinetic Concentration Population. Based on emerging PK results during the course of the study, it was observed that metabolite plasma concentrations were not quantifiable in any PK sample. Hence, PK parameters could not be estimated for metabolite.||||||
2561696|NCT02647281|Secondary|Cmax, C24 and C168 of the Metabolite of GSK3389404 Following Single Dose on Day 1 of Part 2|Blood samples were collected to evaluate Cmax, C24 and C168 of the metabolite of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose|Pharmacokinetic Concentration Population. Based on emerging PK results during the course of the study, it was observed that metabolite plasma concentrations were not quantifiable in any PK sample. Hence, PK parameters could not be estimated for metabolite.||||||
2561697|NCT02647281|Secondary|AUC (0-t), AUC(0-24), AUC(0-168) and AUC (0-inf) of the Metabolite of GSK3389404 Following Single Dose on Day 1 of Part 2|Blood samples were collected to evaluate AUC (0-t), AUC (0-24), AUC (0-168) and AUC (0-inf) of the metabolite of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose|Pharmacokinetic Concentration Population. Based on emerging PK results during the course of the study, it was observed that metabolite plasma concentrations were not quantifiable in any PK sample. Hence, PK parameters could not be estimated for metabolite.||||||
2561698|NCT02647281|Secondary|Tmax, T1/2 and Tlag of the Metabolite of GSK3389404 Following Single Dose in Part 1|Blood samples were collected to evaluate Tmax, T1/2 and Tlag of the metabolite of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose|Pharmacokinetic Concentration Population. Based on emerging PK results during the course of the study, it was observed that metabolite plasma concentrations were not quantifiable in any PK sample. Hence, PK parameters could not be estimated for metabolite.||||||
2561699|NCT02647281|Secondary|Cmax, C24 and C168 of the Metabolite of GSK3389404 Following Single Dose in Part 1|Blood samples were collected to evaluate Cmax, C24 and C168 of the metabolite of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose|Pharmacokinetic Concentration Population. Based on emerging PK results during the course of the study, it was observed that metabolite plasma concentrations were not quantifiable in any PK sample. Hence, PK parameters could not be estimated for metabolite.||||||
2561700|NCT02647281|Secondary|AUC (0-inf), AUC(0-t), AUC(0-24) of the Metabolite of GSK3389404 After Single Dose in Part 1|Blood samples were collected to evaluate AUC (0-inf), AUC (0-t) and AUC (0-24) of metabolite of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose|Pharmacokinetic Concentration Population. Based on emerging PK results during the course of the study, it was observed that metabolite plasma concentrations were not quantifiable in any PK sample. Hence, PK parameters could not be estimated for metabolite.||||||
2561701|NCT02647281|Secondary|Trough Plasma Concentrations of GSK3389404 in Part 2|For Part 2, mean plasma GSK3389404 pre-dose values between Day 1 to Day 29 and Ctau were plotted against time to assess attainment of GSK3389404 steady state following multiple dose administration. Achievement of plasma GSK3389404 steady-state was assessed by calculating the 90% confidence interval (CI) of the slope of the linear regression of log (Ctau) versus time. NA indicates data was not available.|Pre-dose on Days 8, 15, 22 and 29|Pharmacokinetic Concentration Population|||Ratio||Standard Deviation|Mean
2561702|NCT02647281|Secondary|Time Invariance (LI) of GSK3389404 in Part 2|For Part 2, time invariance was evaluated by comparing AUC (0-tau) for Day 22 to AUC (0-inf) for Day 1. For each dose level, a linear mixed effect model was fitted with the log transformed PK parameter as the dependent variable, day as a fixed effect and subject as a random effect. Only those participants with data available at the specified time points were analyzed.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose; Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)|Pharmacokinetic Concentration Population|||Ratio||Standard Deviation|Mean
2561703|NCT02647281|Secondary|Accumulation Ratio by AUC (RAUC), by Cmax (RCmax), by C24 (RC24) and by Ctau (RCtau) of GSK3389404 in Part 2|For Part 2, the extent of accumulation of GSK3389404 was evaluated by comparing AUC (0-tau), Cmax, C24 and Ctau on Day 22 to AUC (0-168), Cmax, C24 and C168 on Day 1. For each dose level, a linear mixed effect model was fitted with the log transformed PK parameter as the dependent variable, day as a fixed effect and subject as a random effect.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose; Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)|Pharmacokinetic Concentration Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).|||Ratio||Standard Deviation|Mean
2561704|NCT02647281|Secondary|Dose Proportionality of GSK202007 for Dose Range 30 mg - 120 mg After Multiple Dose Administrations|Results of proportionality assessment using power model and ANOVA following multiple doses are presented. Slope estimates and 90% confidence interval are presented for Day 22 of Part 2.|Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115) in Part 2|Pharmacokinetic Concentration Population|||ratio||90% Confidence Interval|Number
2561739|NCT02646891|Secondary|Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Adults and Toddlers|Measured at Baseline and 28 days after the final injection (Day 84 for adults; Day 28 for toddlers).|Baseline and Day 28 for toddlers or Day 84 for adults|Per-protocol population participants with valid specimens at each time point.|||titer||95% Confidence Interval|Geometric Mean
2561705|NCT02647281|Secondary|Dose Proportionality of GSK202007 for Dose Range 10 mg - 120 mg After Single Dose Administrations|Results of dose proportionality assessment using power model and analysis of variance (ANOVA) following single dose administariton (Part 1 and Day 1 in Part 2) are presented. Slope estimates and 90% confidence interval are presented for combined data of Day 1 of Part 1 and 2.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose; Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose in Part 2.|Pharmacokinetic Concentration Population (combined for Part 1 and 2). Only data available at the specified time points was analyzed. (represented by n=X in the category titles).|||ratio||90% Confidence Interval|Number
2561706|NCT02647281|Primary|Cl/F of GSK3389404 Following Dosing on Day 22 of Part 2|Blood samples were collected to evaluate Cl/F of GSK3389404 on Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 113+- 2 days).|Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)|Pharmacokinetic Concentration Population|||Liter per hour||Standard Deviation|Mean
2561707|NCT02647281|Primary|Tmax, T1/2 and Tlag of GSK3389404 Following Dosing on Day 22 of Part 2|Blood samples were collected to evaluate Tmax, T1/2 and Tlag of GSK3389404 on Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 113+- 2 days).|Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)|Pharmacokinetic Concentration Population|||Hour||Standard Deviation|Mean
2561708|NCT02647281|Primary|Observed Concentration at the End of the Dosing Interval (Ctau), C24 and Cmax of GSK3389404 Following Dosing on Day 22 of Part 2|Blood samples were collected to evaluate Ctau, C24 and Cmax of GSK3389404 on Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 113+- 2 days ).|Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)|Pharmacokinetic Concentration Population|||ng/mL||Standard Deviation|Mean
2561709|NCT02647281|Primary|AUC(0-24) and AUC From Time Zero to the End of the Dosing Interval [AUC(0-tau)] of GSK3389404 Following Dosing on Day 22 of Part 2|Blood samples were collected to evaluate AUC (0-24) and AUC (0-tau) of GSK3389404 on Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 113+- 2 days ).|Day 22 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 29, 36, 50, 71 and at Follow-up (Day 115)|Pharmacokinetic Concentration Population|||ng*hour/mL||Standard Deviation|Mean
2561710|NCT02647281|Primary|CL/F of GSK3389404 Following Single Dose on Day 1 of Part 2|Blood samples were collected to evaluate CL/F of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose. Only those participants with data available at the specified time points were analyzed.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose|Pharmacokinetic Concentration Population|||Liter per hour||Standard Deviation|Mean
2561711|NCT02647281|Primary|Tmax, T1/2 and Tlag of GSK3389404 Following Single Dose on Day 1 of Part 2|Blood samples were collected to evaluate Tmax, T1/2 and Tlag of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose|Pharmacokinetic Concentration Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).|||Hour||Standard Deviation|Mean
2561712|NCT02647281|Primary|Cmax, C24 and C168 of GSK3389404 Following Single Dose on Day 1 of Part 2|Blood samples were collected to evaluate Cmax, C24 and C168 of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose|Pharmacokinetic Concentration Population|||ng/mL||Standard Deviation|Mean
2561713|NCT02647281|Primary|AUC (0-t), AUC(0-24), AUC From Time Zero to 168 Hours Post-dose [AUC(0-168)] and AUC (0-inf) of GSK3389404 Following Single Dose on Day 1 of Part 2|Blood samples were collected to evaluate AUC (0-t), AUC (0-24), AUC (0-168) and AUC (0-inf) of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 15 post-dose|Pharmacokinetic Concentration Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).|||ng*hour/mL||Standard Deviation|Mean
2561714|NCT02647281|Primary|Apparent SC Plasma Clearance (CL/F) of GSK3389404 Following Single Dose in Part 1|Blood samples were collected to evaluate CL/F of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose|Pharmacokinetic Concentration Population|||Liter per hour||Standard Deviation|Mean
2561715|NCT02647281|Primary|Time to Maximum Observed Concentration (Tmax), Terminal Half-life (T1/2) and Lag Time (Tlag) of GSK3389404 Following Single Dose in Part 1|Blood samples were collected to evaluate Tmax, T1/2 and Tlag of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose|Pharmacokinetic Concentration Population|||Hour||Standard Deviation|Mean
2561716|NCT02647281|Primary|Maximum Observed Concentration (Cmax), Observed Concentration at 24 Hours (C24) and at 168 Hours (C168) of GSK3389404 Following Single Dose in Part 1|Blood samples were collected to evaluate Cmax, C24 and C168 of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose|Pharmacokinetic Concentration Population|||ng/mL||Standard Deviation|Mean
2561740|NCT02646891|Secondary|Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Adults and Toddlers, by Vaccine Antigen|Measured at Baseline and 28 days after the final injection (Day 84 for adults; Day 28 for toddlers).|Baseline and Day 28 for toddlers or Day 84 for adults|Per-protocol population participants with valid specimens at each time point.|||titer||95% Confidence Interval|Geometric Mean
2561717|NCT02647281|Primary|Area Under the Plasma Concentration Curve (AUC) From Time Zero to Infinity [AUC (0-inf)], AUC From Time Zero to the Time of Last Quantifiable Concentration [AUC(0-t)], AUC From Time Zero to 24 Hours [AUC(0-24)] of GSK3389404 After Single Dose in Part 1|Blood samples were collected to evaluate AUC (0-inf), AUC (0-t) and AUC (0-24) of GSK3389404 on Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose. Pharmacokinetic Concentration Population was defined as participants who underwent plasma PK sampling and had evaluable PK assay results post-dose.|Day 1 (pre-dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose; and on Days 8 and 30 post-dose|Pharmacokinetic Concentration Population|||Nanogram*hour per milliliter(ng*hour/mL)||Standard Deviation|Mean
2561718|NCT02647281|Primary|Number of Participants With 12-lead Electrocardiogram (ECG) Findings in Part 1|12-lead ECGs were recorded at Baseline (Day 1, pre-dose) and at 1, 4, 8, 12, 24 and 48 hour post dose; and on Days 8 and 30. Measurements were obtained after resting for at least 5 minutes in a supine position. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value. Number of participants with worst change from Baseline in ECG have been presented as clinically significant (CS) change or not a clinically significant (NCS) change.|Day 1 (pre-dose) and up to 31 days|Safety Population|||Participants|||Count of Participants
2561719|NCT02647281|Primary|Change From Baseline in Body Temperature at the Indicated Time Points in Part 2|Body temperature was taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 6, 8, 12, 24, 48 and 72 hour post Day 1 dose; on Days 8 and 15; Day 22 (pre-dose) and at 1, 4, 6, 12, 24, 48 and 72 hours post Day 22 dose; on Days 29, 36, 50, 71 and at Follow-up visit (Day 113+- 2 days). Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Day 1 (pre-dose) and up to 115 days|Safety Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).|||Degree Celsius||Standard Deviation|Mean
2561720|NCT02647281|Primary|Change From Baseline in RR at the Indicated Time Points in Part 2|Respiratory rate was taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 6, 8, 12, 24, 48 and 72 hour post Day 1 dose; on Days 8 and 15; Day 22 (pre-dose) and at 1, 4, 6, 12, 24, 48 and 72 hours post Day 22 dose; on Days 29, 36, 50, 71 and at Follow-up visit (Day 113+- 2 days). Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Day 1 (pre-dose) and up to 115 days|Safety Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).|||Breaths per minute||Standard Deviation|Mean
2561721|NCT02647281|Primary|Change From Baseline in PR at the Indicated Time Points in Part 2|Pulse rate was taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 6, 8, 12, 24, 48 and 72 hour post Day 1 dose; on Days 8 and 15; Day 22 (pre-dose) and at 1, 4, 6, 12, 24, 48 and 72 hours post Day 22 dose; on Days 29, 36, 50, 71 and at Follow-up visit (Day 113+- 2 days). Measurements were obtained after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Day 1 (pre-dose) and up to 115 days|Safety Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).|||bpm||Standard Deviation|Mean
2561722|NCT02647281|Primary|Change From Baseline in SBP and DBP at the Indicated Time Points in Part 2|SBP and DBP were taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 6, 8, 12, 24, 48 and 72 hour post Day 1 dose; on Days 8 and 15; Day 22 (pre-dose) and at 1, 4, 6, 12, 24, 48 and 72 hours post Day 22 dose; on Days 29, 36, 50, 71 and at Follow-up visit (Day 113 +- 2 days). Measurements were obtained after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Day 1 (pre-dose) and up to 115 days|Safety Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).|||mmHg||Standard Deviation|Mean
2561723|NCT02647281|Primary|Change From Baseline in Body Temperature at the Indicated Time Points in Part 1|Temperature was taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 8, 12, 24, 48 and 72 hour post dose; and on Days 8 and 30. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Day 1 (pre-dose) and up to 30 days|Safety Population|||Degree Celsius||Standard Deviation|Mean
2561724|NCT02647281|Primary|Change From Baseline in Respiratory Rate (RR) at the Indicated Time Points in Part 1|Respiratory rate was taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 8, 12, 24, 48 and 72 hour post dose; and on Days 8 and 30. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Day 1 (pre-dose) and up to 30 days|Safety Population. Only data available at the specified time points was analyzed. (represented by n=X in the category titles).|||Breaths per minute||Standard Deviation|Mean
2561725|NCT02647281|Primary|Change From Baseline in Pulse Rate (PR) at the Indicated Time Points in Part 1|Pulse rate was taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 8, 12, 24, 48 and 72 hour post dose; and on Days 8 and 30. Measurements were obtained after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Day 1 (pre-dose) and up to 30 days|Safety Population|||Beats per minute (bpm)||Standard Deviation|Mean
2561726|NCT02647281|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1|SBP and DBP were taken at Baseline (Day 1, pre-dose) and at 1, 2, 4, 8, 12, 24, 48 and 72 hour post dose; and on Days 8 and 30. Measurements were obtained after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the last scheduled non-missing measurement taken prior to drug administration. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Day 1 (pre-dose) and up to 30 days|Safety Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2561909|NCT02643082|Secondary|Change From Baseline in FEV1 (L) at Day 15|Change from baseline in Forced Expiratory Volume at 1 second|Baseline and Day 15|ITT Population|||Liters||95% Confidence Interval|Least Squares Mean
2561727|NCT02647281|Primary|Change From Baseline in Complement Factor Bb Levels in Part 2|Blood samples were collected to evaluate complement factors C5a levels. Latest pre-dose assessment at Day 1 or Day 22 was considered as Baseline value. Change from Baseline was calculated as difference between maximum level (lowest of the measurements for specimens collected each after Day 1 and Day 22 study drug administrations) observed post-dose and pre-study drug administration.|Day 1 (pre-dose) and Day 22|Safety Population|||mg/L||Standard Deviation|Mean
2561728|NCT02647281|Primary|Change From Baseline in Complement Factor C5a Levels in Part 2|Blood samples were collected to evaluate complement factors C5a levels. Latest pre-dose assessment at Day 1 or Day 22 was considered as Baseline value. Change from Baseline was calculated as difference between maximum level (lowest of the measurements for specimens collected each after Day 1 and Day 22 study drug administrations) observed post-dose and pre-study drug administration.|Day 1 (pre-dose) and Day 22|Safety Population|||ug/L||Standard Deviation|Mean
2561729|NCT02647281|Primary|Change From Baseline in Complement Factor C3 and C4 Levels in Part 2|Blood samples were collected to evaluate complement factors (C3 and C4) levels. Latest pre-dose assessment at Day 1 or Day 22 was considered as Baseline value. Change from Baseline was calculated as difference between minimum level (lowest of the measurements for specimens collected each after Day 1 and Day 22 study drug administrations) observed post-dose and pre-study drug administration|Day 1 (pre-dose) and Day 22|Safety Population|||G/L||Standard Deviation|Mean
2561730|NCT02647281|Primary|Change From Baseline in Complement Split Product Bb Levels in Part 1|Blood samples were collected to evaluate complement split product Bb levels. Latest pre-dose assessment at Day 1 was considered as Baseline value. Change from Baseline was calculated as difference between maximum level (highest of the measurements for specimens collected) observed post-dose and pre-study drug administration|Day 1 (pre-dose) and up to 31 days|Safety Population|||mg per liter (mg/L)||Standard Deviation|Mean
2561731|NCT02647281|Primary|Change From Baseline in Complement Split Product C5a Levels in Part 1|Blood samples were collected to evaluate complement split product C5a levels. Latest pre-dose assessment at Day 1 was considered as Baseline value. Change from Baseline was calculated as difference between maximum level (highest of the measurements for specimens collected) observed post-dose and pre-study drug administration.|Day 1 (pre-dose) and up to 31 days|Safety Population|||Microgram per liter (ug/L)||Standard Deviation|Mean
2561732|NCT02647281|Primary|Change From Baseline in Complement Factor Component 3 (C3) and C4 Levels in Part 1|Blood samples were collected to evaluate complement factors (C3 and C4) levels. Latest pre-dose assessment at Day 1 was considered as Baseline value. Change from Baseline was calculated as difference between minimum level (lowest of the measurements for specimens collected) observed post-dose and pre-study drug administration.|Day 1 (pre-dose) and up to 31 days|Safety Population|||Gram per liter (g/L)||Standard Deviation|Mean
2561733|NCT02647281|Primary|Number of Participants With Laboratory Values of Potential Clinical Importance in Part 2|Blood samples were collected for hematology, clinical chemistry, coagulation parameters and urinalysis. Abnormalities of potential clinical importance were evaluated as per DAIDS table for grading the severity of adult and pediatric adverse events. Laboratory abnormalities of DAIDS Grade 1 or higher were considered as of potential clinical importance and were summarized.|Up to 115 days|Safety Population|||Participants|||Count of Participants
2561734|NCT02647281|Primary|Number of Participants With Laboratory Values of Potential Clinical Importance in Part 1|Blood samples were collected for hematology, clinical chemistry, coagulation parameters and urinalysis. Abnormalities of potential clinical importance were evaluated as per Division of Acquired Immune Deficiency Syndrome [DAIDS] table for grading the severity of adult and pediatric adverse events. Laboratory abnormalities of DAIDS Grade 1 or higher were considered as of potential clinical importance and were summarized.|Up to 62 days|Safety Population|||Participants|||Count of Participants
2561735|NCT02647281|Primary|Number of Participants With Any Non-serious AE; Any SAE; Any AELD in Part 2|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Participants who received any of the study treatment and had any AE or SAE or AELD were considered for analysis.|Up to 115 days|Safety Population|||Participants|||Count of Participants
2561736|NCT02647281|Primary|Number of Participants With Any Non-serious Adverse Event (AE); Any Serious AE (SAE); Any AEs Leading to Discontinuation of Study Treatment (AELD) in Part 1|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Participants who received any of the study treatment and had any AE or SAE or AELD were considered for analysis. Safety Population comprised of all participants who received at least 1 dose of study treatment.|Up to 62 days|Safety Population|||Participants|||Count of Participants
2561737|NCT02646891|Post-Hoc|Number of Toddlers With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain|The number of toddlers with a 4-fold or greater increase from Baseline 4 weeks after vaccination in neutralizing antibody titers to each of the three rotavirus strains from which the vaccine antigens were derived.|Day 28|Per-protocol population|||Participants|||Count of Participants
2561738|NCT02646891|Post-Hoc|Number of Adults and Infants With ≥ 4-fold Rise in Neutralizing Antibody Titer to Each Rotavirus Strain|"The number of adults and infants with a 4-fold or greater increase from Baseline in neutralizing antibody titers to each of the three rotavirus strains from which the vaccine antigens were derived 4 weeks after the second (Day 56) and third (Day 84) vaccinations.~For infants, antibody titer was adjusted for decay in maternal antibodies."|Day 56 and Day 84|Per-protocol population participants with valid specimens at each time point.|||Participants|||Count of Participants
2561742|NCT02646891|Secondary|Number of Adults and Toddlers With Neutralizing Antibody Responses to Each Rotavirus Strain|Neutralizing antibody response was defined as a ≥ 2.7-fold rise in antibody titer between Baseline and 28 days after the final injection (Day 84 for adults and Day 28 for toddlers) for each of the three rotavirus strains from which the vaccine antigens were derived (Wa, DS-1, and 1076).|Day 84 for adults; Day 28 for toddlers|Per-protocol population|||Participants|||Count of Participants
2561743|NCT02646891|Secondary|Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse, by Vaccine Antigen|Seroresponse was defined as a four-fold rise or greater in IgA antibody titer between Baseline and 28 days after the final injection (Day 84 for adults and Day 28 for toddlers). Measured by enzyme-linked immunosorbent assay (ELISA).|Day 84 for adults; Day 28 for toddlers|Per-protocol population|||Participants|||Count of Participants
2561744|NCT02646891|Secondary|Number of Adults and Toddlers With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse, by Vaccine Antigen|Seroresponse was defined as a four-fold rise or greater in IgG antibody titer between Baseline and 28 days after the final injection (Day 84 for adults and Day 28 for toddlers). Measured by enzyme-linked immunosorbent assay (ELISA).|Day 84 for adults; Day 28 for toddlers|Per-protocol population|||Participants|||Count of Participants
2561745|NCT02646891|Secondary|Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Second Vaccination|Neutralizing antibody response was defined as a ≥ 2.7-fold rise in antibody titer between Baseline and 28 days after the second injection (Day 56). Neutralizing antibodies to each of the three rotavirus strains from which the vaccine antigens were derived (Wa, DS-1, and 1076) were measured using a validated assay. For infants, antibody titers were adjusted for decay in maternal antibodies.|Day 56, prevaccination|Per-protocol population, participants with available data for each strain|||Participants|||Count of Participants
2561746|NCT02646891|Secondary|Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen|Seroresponse was defined as a four-fold rise or greater in antibody titer between Baseline and 28 days after the second injection (Day 56). Measured by enzyme-linked immunosorbent assay (ELISA) to whole viral lysate.|Day 56, pre-vaccination|Per-protocol population; participants with available data for each antigen|||Participants|||Count of Participants
2561747|NCT02646891|Secondary|Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Second Vaccination, by Vaccine Antigen|Seroresponse was defined as a four-fold rise or greater in antibody titer between Baseline and 28 days after the 2nd injection (Day 56). Measured by enzyme-linked immunosorbent assay (ELISA) and adjusted for decay in maternal antibodies. The estimated maternal antibody half-life was derived from linear regression of Log2 transformed titers in placebo recipients from the combined infant cohorts.|Day 56, pre-vaccination|Per-protocol population; participants with available data for each antigen|||Participants|||Count of Participants
2561748|NCT02646891|Secondary|Number of Participants Experiencing Adverse Events (AE) Over the Entire Study Period|"Any symptom starting after 7 days post any study injection was recorded as an adverse event. A serious adverse event (SAE) is any event that occurred from the first dose of study drug that resulted in any of the following outcomes:~Death - Life-threatening AE~Inpatient hospitalization or prolongation of existing hospitalization~Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions~Congenital abnormality or birth defect~Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant or require medical or surgical intervention to prevent one of the outcomes listed in the above definition of serious event.~AEs related to study drug were those events for which there was a reasonable possibility that the study drug caused the event In the opinion of the site investigator."|Up to 6 months after the last injection (224 days for adults and infants; 168 days for toddlers)|Safety population|||Participants|||Count of Participants
2561749|NCT02646891|Primary|Geometric Mean Titers of Neutralizing Antibody Against Rotavirus Strains Among Infants|Neutralizing antibodies to each of the three rotavirus strains from which the vaccine antigens were derived (Wa, DS-1, and 1076) were measured at Baseline and 28 days after the second injection (Day 56 pre-vaccination; secondary outcome) and third injection (Day 84; primary outcome).|Baseline and Days 56 (pre-vaccination) and 84|Per-protocol population participants with valid specimens at each time point.|||titer||95% Confidence Interval|Geometric Mean
2561750|NCT02646891|Primary|Anti-P2-VP8 Immunoglobulin A (IgA) Geometric Mean Titers Among Infants, by Vaccine Antigen|Measured by ELISA at Baseline, 28 days after the second injection (Day 56 pre-vaccination; secondary outcome) and 28 days after the third and final injection (Day 84; primary outcome).|Baseline and Days 56 (pre-vaccination) and 84|Per-protocol population; participants with valid specimens at each time point.|||titer||95% Confidence Interval|Geometric Mean
2561751|NCT02646891|Primary|Anti-P2-VP8 Immunoglobulin G (IgG) Geometric Mean Titers Among Infants, by Vaccine Antigen|Measured by ELISA at Baseline, 28 days after the second injection (Day 56 pre-vaccination; secondary outcome) and 28 days after the third and final injection (Day 84; primary outcome).|Baseline and Days 56 (pre-vaccination) and 84|Per-protocol population; participants with valid specimens at each time point.|||titer||95% Confidence Interval|Geometric Mean
2561752|NCT02646891|Primary|Number of Infants With Neutralizing Antibody Responses 4 Weeks After the Third Vaccination to Each Rotavirus Strain|Neutralizing antibody response was defined as a ≥ 2.7-fold rise in antibody titer between Baseline and 28 days after the final injection (Day 84). Neutralizing antibodies to each of the three rotavirus strains from which the vaccine antigens were derived (Wa, DS-1, and 1076) were measured using a validated assay. For infants, antibody titer was adjusted for decay in maternal antibodies.|Day 84|Per-protocol population participants with available data for each strain|||Participants|||Count of Participants
2561753|NCT02646891|Primary|Number of Infants With Anti-P2-VP8 Immunoglobulin A (IgA) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen|Seroresponse was defined as a four-fold rise or greater in antibody titer between Baseline and 28 days after the final injection (Day 84). Measured by enzyme-linked immunosorbent assay (ELISA) to whole viral lysate.|Day 84|Per-protocol population participants with available data|||Participants|||Count of Participants
2561835|NCT02644356|Secondary|Perceived Course Relevance: Increasing Knowledge of Non-pharmacological Approaches|"Investigator-generated scale of perceived importance and relevance of course content: How relevant is the content of this course for increasing palliative care providers' knowledge of non-pharmacological approaches? Likert scale ranges from 1 (not at all) to 4 (extremely)."|30 day follow-up|There was missing data for one subject for this item.|||units on a scale||Standard Deviation|Mean
2561754|NCT02646891|Primary|Number of Infants With Anti-P2-VP8 Immunoglobulin G (IgG) Seroresponse 4 Weeks After the Third Vaccination, by Vaccine Antigen|Seroresponse was defined as a four-fold rise or greater in antibody titer between Baseline and 28 days after the third injection (Day 84). Measured by enzyme-linked immunosorbent assay (ELISA) and adjusted for decay in maternal IgG antibodies. The estimated maternal antibody half-life was derived from linear regression of Log2 transformed titers in placebo recipients from the combined infant cohorts.|Day 84|Per-protocol population included all randomized participants who adhered to the protocol, completed all their scheduled visits and vaccinations up to the analysis time point and presented no major protocol violations (defined as a protocol violation that was considered to have an impact on the immunogenicity results of the study).|||Participants|||Count of Participants
2561755|NCT02646891|Primary|Number of Participants With Local or Systemic Reactions Within 7 Day of Vaccination|"Reactogenicity data (solicited signs or symptoms) were assessed for 7 days after each injection. Participants and parents were instructed to assess and record daily local reactions (injection site pain/tenderness, redness, swelling, itching), as well as systemic signs and symptoms (fever, headache, vomiting, nausea, fatigue, chills and myalgia for adults; and fever, vomiting, decreased appetite, irritability, and decreased activity for toddlers and infants) in a participant memory aid. Reactions were graded on a scale from mild (Grade 1) to life-threatening (Grade 4).~The overall number of participants who experienced any local or systemic reaction is reported. Grades are based on maximum severity per participant."|7 days following each vaccination|Safety population|||Participants|||Count of Participants
2561756|NCT02646891|Primary|Number of Participants Experiencing Adverse Events (AE) Within 28 Days of Any Vaccination|"Any symptom starting after 7 days post any study injection was recorded as an adverse event. A serious adverse event (SAE) is any event that occurred from the first dose of study drug that resulted in any of the following outcomes:~Death~Life-threatening AE~Inpatient hospitalization or prolongation of existing hospitalization~Persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions~Congenital abnormality or birth defect~Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant or require medical or surgical intervention to prevent one of the outcomes listed above.~The severity of adverse events was graded from Mild (grade 1) to Life Threatening (grade 4).~AEs related to study drug were those events for which there was a reasonable possibility that the study drug caused the event In the opinion of the site investigator."|Up to 28 days after any vaccination (up to Day 28 for toddlers and up to Day 84 for infants and adults)|Safety population included all participants who were randomized and received at least one injection of the study drug.|||Participants|||Count of Participants
2561757|NCT02646826|Secondary|Total Hours of Nightly Sleep|The total hours of nightly sleep will be assessed during the 2-week treatment period with one of three dose levels of Paxerol vs. placebo|Up to 2 weeks||||Hours per night||Standard Deviation|Mean
2561758|NCT02646826|Secondary|Duration of First Undisturbed Sleep (DFUS)|DFUS will be assessed during the 2-week treatment period with one of three dose levels of Paxerol vs. placebo|Up to 2 weeks||||Hours||Standard Deviation|Mean
2561759|NCT02646826|Primary|Clinical Benefit Based on Nocturia Quality of Life (NQOL).|The degree of clinical benefit, via NQOL, associated with one of three dose levels of Paxerol vs. placebo is assessed after the 2-week treatment period. This is on a scale of 0 to 100, with 0 being the best score.|Up to 2 weeks||||score on a scale||Standard Deviation|Mean
2561760|NCT02646826|Primary|Change in Nocturia Episodes|Change in number of nocturia episodes associated with one of three dose levels of Paxerol vs. placebo is assessed during the 2-week treatment period.|Up to 2 weeks||||average nightly voids||Standard Deviation|Mean
2561761|NCT02646761|Secondary|Range of Motion (Flexion)|Flexion of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees.|baseline and 10 weeks|The total number analyzed represents the subjects that did not drop out of the study and completed the 10 weeks follow-up assessment.|||degrees||Standard Deviation|Mean
2561762|NCT02646761|Secondary|Range of Motion (Extension)|Extension of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees.|baseline and 10 weeks|The total number analyzed represents the subjects that did not drop out of the study and completed the 10 weeks follow-up assessment.|||degrees||Standard Deviation|Mean
2561763|NCT02646761|Secondary|Performance Based Outcome Measures|The performance based measures included the 6-minute walk test (measured as distance in meters); stair climb test (measured as time in seconds divided by the number of steps); timed up and go test (measured in seconds); and unilateral balance test (measured in seconds). To combine the 4 performance-based outcome measures into a single composite score, the score for each test was converted to a z score (individual's score - overall mean)/overall standard deviation. As such, the z-score represents the number of SD deviations an individual's score is above or below the overall study mean. A z-score of 0 implies the participants score is the same as the mean score. A z-score of 0.1 would indicate that the participant's z score is .1 (10%) of a standard deviation above or below the overall mean. The average of the z scores for each performance-based outcome measure as the unit of analysis.|10 weeks||||z-score||Standard Deviation|Mean
2561764|NCT02646761|Secondary|Number of Subjects Satisfied With InterACTION Device|"Subjects in the interACTION group were asked Would you consider using the InterACTION device if you had to do rehabilitation again in the future?"|10 weeks||||Participants|||Count of Participants
2561765|NCT02646761|Secondary|Number of Participants That Complied With Rehabilitation Program|Compliance with the use of the InterACTION device was measured by reports generated from the device. Subjects in the Standard Physical Therapy Group completed exercise logs that were monitored at each study visit.|10 weeks||||Participants|||Count of Participants
2561766|NCT02646761|Primary|Value Was Evaluated as the Ratio of Change in the Activities of Daily Living Scale Score to the Costs of Rehabilitation.|The value was calculated the ratio of the difference between the 10 week and baseline Activities of Daily Living Scale (ADLS) of the Knee Outcome Survey divided by the total charges for the physical therapy treatment sessions. The ADLS is a 14-item measure of symptoms and activity limitations for individuals with a variety of knee impairments. Items are scored from 0 to 4, and the total score is the sum of all the items divided by 70 and multiplied by 100. The ADLS score ranges from 0 to 100 with higher scores representing less symptoms and greater levels of activity. Higher ratio of the change in the ADLS score to the costs for rehabilitation represents greater value.|10 weeks||||ratio||Standard Deviation|Mean
2561767|NCT02646566|Secondary|Evolution Score of Nausea (0-180 Mins)|The evolution score of nausea was calculated as the area under the curve (AUC) of the nausea scores on a scale 0-10 (where 0 is no nausea and 10 is the worst nausea imaginable) obtained at five pre-planned time points: pre-dose (0-min), and 5, 15 and 30 minutes and 2 hours after administration of study medication, as well as any spontaneously reported episodes of nausea during the time period, plotted against time. A higher score represents a worse outcome.|0-180 minutes after study drug administration|Modified ITT population|||Score on a scale*min||Standard Deviation|Mean
2561768|NCT02646566|Secondary|Maximum Severity of Nausea|Highest recorded nausea score on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.|30 mins to 24 hours after study drug administration|Modified ITT population|||Score on a scale||Standard Deviation|Mean
2561769|NCT02646566|Secondary|Number of Patients With an Incidence of Nausea|Number of patients with nausea score ≥1 on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.|30 mins to 24 hours after drug administration|Modified ITT population|||Participants|||Count of Participants
2561770|NCT02646566|Secondary|Number of Patients With an Incidence of Significant Nausea|Number of patients with nausea score ≥4 on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.|30 mins to 24 hours after study drug administration|Modified ITT population|||Participants|||Count of Participants
2561771|NCT02646566|Secondary|Number of Patients Receiving Rescue Medication|Number of patients receiving pre-specified anti-emetic rescue medication at any time in the 24 hours post-treatment period|0-24 hours after study drug administration|Modified ITT population|||Participants|||Count of Participants
2561772|NCT02646566|Secondary|Number of Patients With Incidence of Emesis|Number of patients experiencing vomiting or retching during the time period from 30 minutes to 24 hours after administration of study medication|30 mins to 24 hours after study drug administration||||Participants|||Count of Participants
2561773|NCT02646566|Secondary|Time to Treatment Failure|Time to first violation of the criteria for complete response|0-24 hours after study drug administration|Modified ITT population|||minutes||Inter-Quartile Range|Median
2561774|NCT02646566|Secondary|Number of Participants With Complete Response 0-6 Hrs|Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes to 6 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 6-hour period after administration of study medication.|0-6 hours after administration of study medication|Modified ITT population|||Participants|||Count of Participants
2561775|NCT02646566|Secondary|Number of Participants With Complete Response 0-4 Hrs|Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes* to 4 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 4-hour period after administration of study medication.|0-4 hours after administration of study medication|Modified ITT population|||Participants|||Count of Participants
2561776|NCT02646566|Secondary|Number of Participants With Complete Response 0-2 Hrs|Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes* to 2 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 2-hour period after administration of study medication.|0-2 hours after administration of study medication|Modified ITT population|||Participants|||Count of Participants
2561777|NCT02646566|Primary|Number of Participants With Complete Response (Success of Initial PONV Treatment)|The primary efficacy variable was the dichotomous variable: success or failure of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes* to 24 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 24-hour period after administration of study medication.|0-24 hours after administration of study medication|Modified ITT population|||Participants|||Count of Participants
2561778|NCT02646449|Primary|Level of Depressive Symptoms|Level of depressive symptoms, as indicated by the score on the Beck Depression Inventory. The Beck Depression Inventory II scoring range is as follows: 0-13 minimal depressive symptoms, 14-19 mild depressive symptoms, 20-28 moderate depressive symptoms and 29-63 severe depressive symptoms.|12 Weeks||||units on a scale||Standard Deviation|Mean
2561779|NCT02646449|Primary|Drinks Per Drinking Day|Level of drinking, as indicated by the number of drinks per day as recorded on the Timeline Follow-Back calendar.|12 Weeks||||Drinks per drinking day||Standard Deviation|Mean
2561780|NCT02646124|Secondary|Participants Satisfied With Treatment|"Participants who answered Yes when asked the question Do you want to receive the same combination of medications during a subsequent visit to the ER?"|1 week||||Participants|||Count of Participants
2561781|NCT02646124|Secondary|Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 72 Hours|Patients needing any analgesic or LBP medication within the previous 72 hours|Assessed three months after emergency department discharge|data not collected||||||
2561782|NCT02646124|Secondary|Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours|Telephone questionnaire is used to assess patients needing any analgesic or low back pain medication within the previous 24 hours.|One week after discharge from the emergency department||||Participants|||Count of Participants
2561783|NCT02646124|Secondary|Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale|Patients with moderate or serve pain. Worst Lower Back Pain (LBP) over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none.|1 week after discharge from emergency department||||Participants|||Count of Participants
2561836|NCT02644356|Secondary|Perceived Course Relevance: Importance of Knowledge About Non-pharmacological Approaches|"Investigator-generated scale of perceived importance and relevance of course content: How important is it for palliative care providers to know about non-pharmacological approaches to symptom management? Likert scale ranges from 1 (not at all) to 4 (extremely)."|30 day follow-up|There was missing data for one subject for this item.|||units on a scale||Standard Deviation|Mean
2561784|NCT02646124|Primary|Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire|"The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a yes or no. The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score."|Between baseline and one week after emergency department discharge||||units on a scale||95% Confidence Interval|Mean
2561785|NCT02645760|Secondary|Change From Baseline in Repositioning Error on Repositioning Test at Week 7|This test was performed by measuring how accurately the participant during sitting that could reposition the lumbar spine into the former lumbar position, after change position in the sagittal plane. The procedure use a laser pointer adjusted to be level, was positioned to have the mark line directly on 0 cm. After having actively moved around, in maximum flexion-extension and return to neutral position, the laser line on the tape-measure, the deviation from the 0 point was measured in centimeter. change = (baseline score - week 7 score)|baseline and week 7|Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group|||centimeter||Standard Deviation|Mean
2561786|NCT02645760|Secondary|Change From Baseline in Back Range of Motion (Flexion) on Modified-modified Schober's Test at Week 7|Modified-modified Schober's test used a tape measure held directly over the spine between points 15 cm above the posterior superior iliac spine (PSIS) with the participant in the neutral standing position on the foot print. The participant was asked to stand with knees locked and bend forward (lumbar flexion) as far as possible without pain; the increase in distance between the marks gave an estimate of lumbar ROM. change =(baseline score - week 7 score)|baseline and week 7|Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group|||centimeter||Standard Deviation|Mean
2561787|NCT02645760|Secondary|Change From Baseline in Functional Disability on Roland-Morris Disability Questionnaire at Week 7|This outcome was assessed by the Roland-Morris disability questionnaire (RMDQ) Thai version that is designed to assess self-rated physical disability caused by LBP. This questionnaire has 24 items. The participant put a tick on the statement when it applies to him that specific day. The scores range from 0 (no disability) to 24 (maximum disability). change = (baseline score - week 7 score|baseline and week 7|Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group|||units on a scale||Standard Deviation|Mean
2561788|NCT02645760|Primary|Change From Baseline in Pain on 11- Point Numerical Rating Scale at Week 7|The 11 point numerical rating scale (11-NRS) is a method to measure pain intensity. The zero represents no pain while 10 represent the worst imaginable pain.The patient is asked to cross or circle a score that the best represents the pain intensity. Change = (week 7 score - baseline score)|baseline an week 7|Analysis of covariance (ANCOVA) was performed to compare differences between groups for outcome measures. To estimate the adjusted mean differences and the 95% confidence intervals for each outcome measure of each group.|||units on a scale||Standard Deviation|Mean
2561789|NCT02645617|Secondary|Adverse Events|Proportion of participants with any emergency medical care OR report of nausea OR not eating OR vomiting OR difficulty swallowing OR swelling around the mouth OR itchiness around the mouth OR hives OR rash OR stomach ache OR diarrhea|within 48 hours||||Participants|||Count of Participants
2561790|NCT02645617|Primary|Soft Tissue|Proportion of participants with any oral ulcerations OR inflammatory response|within 48 hours||||Participants|||Count of Participants
2561791|NCT02645409|Primary|Number of Participants With Presence of Fluorescence of cT1 RCC in Partial Nephrectomy Specimens|Pathology results will be compared with immunohistochemistry results for each patient. Fluorescence will be looked for in the margins of resection for partial nephectomy and in regional lymph nodes and metastases for radical nephrectomy.|During procedure, an average of 2 hours||||Participants|||Count of Participants
2561792|NCT02645253|Secondary|Pharmacodynamic Analysis of AZD7594 by Assessment of Plasma Concentration of Osteocalcin|Assessment of the plasma PD following a single dose of AZD7594|Day 1 (predose) and Day 16 (24 hours postdose)|The pharmacodynamics analysis set will include all subjects who receive at least 1 dose of IMP and for whom it is possible to calculate the cortisol AUEC on Day -1, Day 1 and/or Day 16 and with no major protocol deviations considered to impact on the analysis of the PD (cortisol, plasma DHEAS and osteocalcin) data.|||μg/L||Standard Deviation|Mean
2561793|NCT02645253|Secondary|Pharmacodynamic Analysis of AZD7594 by Assessment of Plasma Concentration of Dehydroepiandrosterone Sulphate (DHEAS)|Assessment of the plasma PD following a single dose of AZD7594|Day 1 (predose) and Day 16 (24 hours postdose)|The pharmacodynamics analysis set will include all subjects who receive at least 1 dose of IMP and for whom it is possible to calculate the cortisol AUEC on Day -1, Day 1 and/or Day 16 and with no major protocol deviations considered to impact on the analysis of the PD (cortisol, plasma DHEAS and osteocalcin) data.|||μmol/L||Standard Deviation|Mean
2561794|NCT02645253|Secondary|Pharmacodynamic Analysis of AZD7594 by Assessment of the Area Under the Effect Curve for Plasma Cortisol From Time Zero to 24 Hours After Dosing (AUEC [0-24]).|"Assessment of the plasma pharmacodynamics (PD) effects of AZD7594 after single and multiple ascending inhaled doses.~AUEC(0-24) was defined as area under the effect curve for plasma cortisol from time zero to 24 hours after dosing."|Day -1 (- 24 hours predose) up to 24 hours postdose; Day 1 and Day 16|The pharmacodynamics analysis set will include all subjects who receive at least 1 dose of IMP and for whom it is possible to calculate the cortisol AUEC on Day -1, Day 1 and/or Day 16 and with no major protocol deviations considered to impact on the analysis of the PD (cortisol, plasma DHEAS and osteocalcin) data.|||min*nmol/L||Standard Deviation|Mean
2561837|NCT02644356|Secondary|Change in Ratings of Confidence in Explaining the Modality From Baseline to 30 Days|Investigator-generated scale of confidence in communicating about the modality to patients, families and colleagues in PC contexts. Likert-scaled items ranging from 0-10, with 0 as lowest and 10 as highest.|Baseline, 30 days|There was missing data for one subject for this item.|||units on a scale||Standard Deviation|Mean
2561795|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Renal Clearance, Estimated by Dividing Ae(0-96) by AUC(0-96) (CLR)|"Assessment of the urine PK following a single dose of AZD7594.~CLR was defined as the renal clearance, estimated by dividing Ae(0-96) by AUC(0-96)."|Day 1 predose spot-collection and interval collection up to 96 hours postdose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2561796|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Percentage of Dose Excreted Unchanged Into the Urine From Time Zero to the Last Measured Time Point for an AZD7594, Estimated by Dividing Ae(0-last) by Dose (fe(0-last)%)|"Assessment of the urine PK following a single dose of AZD7594.~fe(0-last)% was defined as Percentage of dose excreted unchanged into the urine from time zero to the last measured time point for an AZD7594, estimated by dividing Ae(0-last) by dose."|Day 1 predose spot-collection and interval collection up to 96 hours postdose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||Percentage of dose excreted unchanged||Standard Deviation|Mean
2561797|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Cumulative Amount of AZD7594 Excreted From Time Zero to the Last Sampling Interval (Ae [0-last])|"Assessment of the urine PK following a single dose of AZD7594.~Ae(0-last) was defined as Cumulative amount of AZD7594 excreted from time zero to the last sampling interval."|Day 1 predose spot-collection and interval collection up to 96 hours postdose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||pmol||Standard Deviation|Mean
2561798|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Amount of AZD7594 Excreted Into the Urine From Time t1 to t2 (Ae [t1-t2])|"Assessment of the urine PK following a single dose of AZD7594.~Ae (t1-t2) was defined as the amount of AZD7594 excreted into the urine from time t1 to t2."|Day 1 predose spot-collection and interval collection up to 96 hours postdose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||pmol||Standard Deviation|Mean
2561799|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Temporal Change Parameter (TCP)|"Assessment of the plasma PK following a single dose of AZD7594.~Temporal change parameter, calculated as AUC(0-24) [Day 16]/AUC [Day 1].~NOTE: No results were available for participants belonging to AZD7594 200ug and AZD7594 400ug groups."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2561800|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Accumulation Ratio Calculated as AUC(0-24) on Day 16/AUC (0-24) on Day 1 (RAC).|"Assessment of the plasma PK following a single dose of AZD7594.~Accumulation ratio calculated as AUC(0-24) on Day 16/AUC(0-24) on Day 1."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2561801|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Peak Trough Fluctuation (%Fluctuation).|"Assessment of the plasma PK following a single dose of AZD7594.~Peak trough fluctuation calculated as [100*(Css,max- Css,min)/Cav]."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The pharmacodynamics analysis set will include all subjects who receive at least 1 dose of IMP and for whom it is possible to calculate the cortisol AUEC on Day -1, Day 1 and/or Day 16 and with no major protocol deviations considered to impact on the analysis of the PD (cortisol, plasma DHEAS and osteocalcin) data.|||Percentage of fluctuation||Geometric Coefficient of Variation|Geometric Mean
2561802|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of t1/2λz.|"Assessment of the plasma PK following a single dose of AZD7594.~t1/2λz was defined as half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve.~Participant count analyzed = 1"|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2561803|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of Lamda z (λz)|"Assessment of the plasma PK following a single dose of AZD7594.~λz was defined as terminal elimination rate constant, estimated by log-linear least."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||l/hour||Geometric Coefficient of Variation|Geometric Mean
2561804|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment AUC(0-24)/D.|"Assessment of the plasma PK following a single dose of AZD7594.~AUC(0-24)/D was defined as the area under the plasma concentration-time curve from time zero to 24 hours after dosing divided by the dose administered."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||(pmol*h/L)/umol||Geometric Coefficient of Variation|Geometric Mean
2561805|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Css,Max Divided by the Dose Administered (Css,Max/D).|"Assessment of the plasma PK following a single dose of AZD7594.~Css,max/D was defined as observed maximum plasma concentration divided by the dose administered."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||(pmol/L)/umol||Geometric Coefficient of Variation|Geometric Mean
2561806|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of AUC(0-24)|"Assessment of the plasma PK following a single dose of AZD7594.~AUC(0-24) was defined as area under the plasma concentration-time curve from time zero to 24 hours after dosing"|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data|||pmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2561807|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the AUC(0-last)|"Assessment of the plasma PK following a single dose of AZD7594.~AUC(0-last) was defined as Area under the plasma concentration-time curve from time zero to the time of the last quantifiable analyte concentration."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||pmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2561808|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Tmax at Steady State (Tss,Max).|"Assessment of the plasma PK following a single dose of AZD7594.~tss,max was defined as Time to reach maximum concentration, taken directly from the individual concentration-time curve."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||Hours||Full Range|Median
2561809|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Average Concentration Over One Dosing Interval (Cav)|"Assessment of the plasma PK following a single dose of AZD7594.~Cav was defined as average concentration over one dosing interval."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2561810|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Cmin at Steady State (Cmin, ss)|"Assessment of the plasma PK following a single dose of AZD7594.~Cmin, ss was defined as observed minimum concentration, taken directly from the individual concentration-time curve."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2561811|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Cmax at Steady State (Css,Max).|"Assessment of the plasma PK following a single dose of AZD7594.~Css,max was defined as observed maximum plasma concentration at steady state, taken directly from the individual concentration-time curve."|Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2561812|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Observed Minimum Plasma Concentration (Cmin)|Cmin was defined as observed minimum plasma concentration, taken directly from the individual concentration-time curve|Days 5 to 15: Pre-dose|The pharmacokinetic (PK) analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2561813|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the AUC(0-24) Divided by the Dose Administered (AUC(0-24)/D)|"Assessment of the plasma PK following a single dose of AZD7594.~AUC(0-24)/D was defined as area under the plasma concentration-time curve from time zero to 24 hours after dosing divided by the dose administered."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||(pmol*h/L)/umol||Geometric Coefficient of Variation|Geometric Mean
2561814|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the AUC Divided by the Dose Administered (AUC/D).|"Assessment of the plasma PK following a single dose of AZD7594.~AUC/D was defined as Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered.~NOTE: No results were available for participants belonging to AZD7594 200ug and AZD7594 400ug groups."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||(pmol*h/L)/umol||Geometric Coefficient of Variation|Geometric Mean
2561815|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Cmax Divided by the Dose Administered (Cmax/D).|"Assessment of the plasma PK following a single dose of AZD7594.~Cmax/D was defined as observed maximum plasma concentration divided by the dose administered."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||(pmol/L)/umol||Geometric Coefficient of Variation|Geometric Mean
2561816|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration, Estimated by Dividing CL/F by Lamda z (Vz/F)|"Assessment of the plasma PK following a single dose of AZD7594.~Vz/F was defined as apparent volume of distribution during the terminal phase after extravascular administration, estimated by dividing the apparent clearance (CL/F) by λz.~NOTE: No results were available for participants belonging to AZD7594 200ug and AZD7594 400ug groups."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||Litres||Geometric Coefficient of Variation|Geometric Mean
2561817|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (AZD7594) (CL/F).|"Assessment of the plasma PK following a single dose of AZD7594.~CL/F was defined as apparent total body clearance after extravascular administration estimated as dose divided by AUC (AZD7594).~NOTE: No results were available for participants belonging to AZD7594 200ug and AZD7594 400ug groups."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2561818|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Mean Residence Time From Time Zero Extrapolated to Infinity (MRT).|"Assessment of the plasma PK following a single dose of AZD7594.~MRT was defined as Mean residence time from time zero extrapolated to infinity.~NOTE: No results were available for participants belonging to AZD7594 200ug and AZD7594 400ug groups."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2561819|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Half-life Associated With the Terminal Slope of a Semi-logarithmic Concentration-time Curve (t1/2λz).|"Assessment of the plasma PK following a single dose of AZD7594.~t1/2λz was defined as half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve.~NOTE: No results were available for participants belonging to AZD7594 400ug group."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||Hours||Standard Deviation|Mean
2561820|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 by Assessment of the Terminal Elimination Rate Constant, Estimated by Log-linear Least Squares Regression of the Terminal Part of the Concentration-time Curve(Lamda z or λz).|"Assessment of the plasma PK following a single dose of AZD7594.~λz was defined as terminal elimination rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||l/h||Geometric Coefficient of Variation|Geometric Mean
2561821|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the AUC From Time Zero Extrapolated to Infinity (AUC).|"Assessment of the plasma PK following a single dose of AZD7594.~AUC was defined as area under the plasma concentration-time curve from time zero extrapolated to infinity. AUC is estimated by AUC(0-last) + Clast/λz where Clast is the last observed quantifiable concentration.~NOTE: No results were available for participants belonging to AZD7594 2ug and AZD7594 400ug groups."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||h*pmol/L||Geometric Coefficient of Variation|Geometric Mean
2561822|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the AUC From Time Zero to 24 Hours After Dosing (AUC [0-24]).|"Assessment of the plasma PK following a single dose of AZD7594.~AUC (0-24) was defined as area under the plasma concentration-time curve from time zero to 24 hours after dosing."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||h*pmol/L||Geometric Coefficient of Variation|Geometric Mean
2561838|NCT02644356|Secondary|Change in Ratings of Confidence in Making Evidence-based Recommendations for the Modality in PC Planning From Baseline to 30 Days|Investigator-generated scale of confidence in making evidence-based recommendations about the modality. Likert-scaled items ranging from 0-10, with 0 as lowest and 10 as highest.|Baseline, 30 days|There was missing data for one subject for this item.|||units on a scale||Standard Deviation|Mean
2561823|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Time of Last Quantifiable Analyte Concentration (AUC [0-last])|"Assessment of the plasma PK following a single dose of AZD7594.~AUC (0-last) was defined as the area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||h*pmol/L||Geometric Coefficient of Variation|Geometric Mean
2561824|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Time to Reach Maximum Plasma Concentration (Tmax)|"Assessment of the plasma PK following a single dose of AZD7594.~tmax was defined as time to reach maximum plasma concentration, taken directly from the individual concentration-time curve."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The PK analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||Hours||Full Range|Median
2561825|NCT02645253|Secondary|Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Observed Maximum Plasma Concentration (Cmax)|"Assessment of the plasma PK following a single dose of AZD7594.~Cmax was defined as observed maximum plasma concentration, taken directly from the individual concentration-time curve."|Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.|The pharmacokinetic (PK) analysis set consisted of all subjects in the safety analysis set who received AZD7594 and had at least 1 measured AZD7594 plasma concentration at a scheduled PK time point post-dose, with no major protocol deviations thought to impact on the analysis of the PK data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2561826|NCT02645253|Primary|Safety and Tolerability of AZD7594 by Assessment of the Number of Participants With Adverse Events|To assess the safety and tolerability of single and multiple doses of AZD7594|At screening (Day -28, Day -02 and Day -1), Treatment period (Days 1 to 20) and Follow-up (Day 29).|All subjects who received at least one dose of IMP and for whom any post-dose data were available were included in the safety analysis set.|||Pariticpants|||Number
2561827|NCT02645123|Primary|Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms)|The data was recorded using relevant software (Cortex, Calcium Solver, Skeleton Builder, DV Reference, Sky Scripting, KinTools RT). Κinetic and kinematic data were assessed and analysed at 3 different gait cycle time moments defined by the gait cycle and the amount of ground reaction force (GRF) during both left and right foot contact: moment 1 (T1) was at maximum GRF during heel strike, moment 2 (T2) at minimum GRF during mid stance, and moment 3 (T3) at maximum GRF during acceleration before toe off (http://www.oandplibrary.org/popup.asp?frmItemId=2A1E740F-13FD-4A68-B8A3-83A407795B5F&frmType=image&frmId=1). From these, we extrapolated the quotient (between R and L kinetic and kinematic data) values. A value of 1 would mean absolute symmetry between left and right side (Seliktar and Mizrahi, 1986). the participants walked for 10 times and the mean values of the best 3 measurements were used for analysis.|before the beginning and after the end of 5 weeks for each patient|all participants were chronic low back pain patients with a variable degree of vertebral disc degeneration defined by the modified Pfirrmann scale|||quotient: degrees/degrees=no unit||Standard Deviation|Mean
2561828|NCT02645123|Primary|Change in the Roland-Morris Disability Questionnaire|"The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The Roland-Morris Disability Questionnaire is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain.~For patients with severe disability the Oswestry disability questionnaire is recommended. in this case, we used the 24 question version in which 0 means no disability and 24 means total disability."|before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient||||units on a scale||Standard Deviation|Mean
2561829|NCT02645123|Primary|Change in the Oswestry Low Back Pain Disability Index|this is a self rated questionnaire that is expressed in a percentage with 0% meaning no disability and 100% meaning total disability. The minimum detectable change is reported to be 10% points|before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient||||units on a scale||Standard Deviation|Mean
2561830|NCT02645123|Primary|Change in the Numerical Pain Rating Scale|this scale expresses the self rated pain levels in a 0 to 10 range with 0 meaning no pain and 10 the worst imaginable pain.|before the beginning, after the end of 5 weeks and 6 months after the last treatment session for each patient||||units on a scale||Standard Deviation|Mean
2561831|NCT02645019|Primary|Intracuff Pressure After Probe Removal|Intracuff pressure in cmH2O of cuffed ETT or LMA after EGD probe is removed.|Immediately after probe removal|Number of participants analyzed in each row is number that received each type of airway.|||cmH2O||Standard Deviation|Mean
2561832|NCT02645019|Primary|Intracuff Pressure With Probe in Place|Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD while probe is in place.|At time of EGD while probe is in place|Number of participants analyzed in each row is number that received each type of airway.|||cmH2O||Standard Deviation|Mean
2561833|NCT02645019|Primary|Intracuff Pressures During Probe Insertion|Intracuff pressure in cmH2O of cuffed ETT or LMA during EGD probe insertion.|At time of EGD probe insertion|Number of participants that received each type of airway.|||cmH2O||Standard Deviation|Mean
2561834|NCT02644356|Secondary|Perceived Course Relevance: Potential of Course to Contribute to Improved Patient Care|"Investigator-generated scale of perceived importance and relevance of course content: To what degree do you think this course could potentially contribute to improved patient care? Likert scale ranges from 1 (not at all) to 4 (extremely)."|30 day follow-up|There was missing data for one subject for this item.|||units on a scale||Standard Deviation|Mean
2561865|NCT02643979|Secondary|Number of Participants With Post-operative Nausea and/or Vomiting||up to 6 months||||Participants|||Count of Participants
2561839|NCT02644356|Secondary|Change in Ratings of Confidence in Understanding a Modality's Safety Considerations in PC From Baseline to 30 Days|Investigator-generated scale of confidence in understanding modality safety considerations. Likert-scaled items ranging from 0-10, with 0 as lowest and 10 as highest.|Baseline, 30 days|There was missing data for one subject for this item.|||units on a scale||Standard Deviation|Mean
2561840|NCT02644356|Primary|Change in Test Scores on Knowledge of Course Content From Baseline to 30 Days|Investigator-generated test of change in knowledge about theory, mechanisms of action, delivery, indications for use, evidence of efficacy; total of 45 multiple choice questions covering three modalities: acupuncture, massage, and music interventions. Range of total possible correct responses was from 0-45, with subscores as follows: range for acupuncture, 0-15; massage, 0-16; music interventions, 0-14. Total score is the sum of the combined subscores.|Baseline, 30 days|Disciplines: Nursing, 22; physician, 11; social work, 13; chaplaincy, 4; administrators, 4; counseling/psychology, 2 (some reported more than one discipline).|||units on a scale||Standard Deviation|Mean
2561841|NCT02644278|Primary|Part A: Number of Participants With Clinical Significant Abnormalities in Electrocardiogram(ECG) Parameters|ECG parameters included heart rate, pulse rate, QRS,QT, RR, QTcB and QTcF. Clinical significance was determined by the investigator. Number of participants with clinical significant abnormalities in ECG parameters reported here.|Baseline up to 28 days after the last dose of study treatment, assessed up to 53.1 weeks|The safety analysis set included all participants who had received at least 1 dose of the study treatment.|||Participants|||Count of Participants
2561842|NCT02644278|Primary|Part A: Number of Participants With Clinical Significant Abnormalities Echocardiograms|Echocardiogram is a graphic outline of the heart's movement. Clinical significance was determined by the investigator. Number of participants with clinical significant abnormalities in Echocardiograms reported here.|Baseline up to 28 days after the last dose of study treatment, assessed up to 53.1 weeks|The safety analysis set included all participants who had received at least 1 dose of the study treatment.|||Participants|||Count of Participants
2561843|NCT02644278|Primary|Part A: Number of Participants With Clinical Significant Abnormalities in Vital Signs|Vital signs assessment included blood pressure, pulse rate and body temperature. Clinical significance was determined by the investigator. Number of participants with clinical significant abnormalities in vital Signs reported here.|Baseline up to 28 days after the last dose of study treatment, assessed up to 53.1 weeks|The safety analysis set included all participants who had received at least 1 dose of the study treatment.|||Participants|||Count of Participants
2561844|NCT02644278|Secondary|Part A: Number of Participants With Best Overall Response Evaluated by Response Criteria Evaluation (RECIST 1.1)|The best overall response was defined as the number of participants who had achieved complete response (CR) or partial response (PR) as the best overall response according to radiological assessments as adjudicated by the IRC from randomization until the first occurrence of progressive disease (PD). CR: Complete Response (CR) defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. PD defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started.|Up to 2 years|Full analysis set included all participants who had received at least 1 dose of the study treatment.|||Participants|||Count of Participants
2561845|NCT02644278|Secondary|Part A: Time to Reach Maximum Plasma Concentration From Zero to 96 Hours Post Dose (tmax0-96h) of Pegylated Liposomal Doxorubicin|Tmax is time to reach maximum observed plasma concentration obtained directly from the concentration versus time curve from zero to 96 hours post dose.|Pre-infusion and at 1, 2, 4, 6, 24, 72 and 96 hours after infusion in Cycle 1 (each Cycle is of 28 days)|The Pharmacokinetic (PK) analysis included all participants who had received at least 1 dose of VX-984 or PLD and provided at least 1 measurable post dose concentration of VX-984 or one measurable post dose concentration of PLD.|||Hours||Full Range|Median
2561846|NCT02644278|Secondary|Part A: Maximum Observed Plasma Concentration (Cmax0-96h) From Time Zero to 96 Hours Post Dose of Pegylated Liposomal Doxorubicin|Cmax is the maximum observed plasma concentration obtained directly from concentration versus time curve from zero to 96 hours|Pre-infusion and at 1, 2, 4, 6, 24, 72 and 96 hours after infusion in Cycle 1 (each Cycle is of 28 days)|The Pharmacokinetic (PK) analysis included all participants who had received at least 1 dose of VX-984 or PLD and provided at least 1 measurable post dose concentration of VX-984 or one measurable post dose concentration of PLD.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561847|NCT02644278|Secondary|Part A: Area Under the Plasma Concentration Curve From Time Zero to 96 Hours Post Dose AUC(0-96h) of Pegylated Liposomal Doxorubicin|The AUC(0-96h) was estimated by determining the total area under the curve of the concentration versus curve extrapolated from 0 to 96 hours.|Pre-infusion and at 1, 2, 4, 6, 24, 72 and 96 hours after infusion in Cycle 1 (each Cycle is of 28 days)|The Pharmacokinetic (PK) analysis included all participants who had received at least 1 dose of VX-984 or PLD and provided at least 1 measurable post dose concentration of VX-984 or one measurable post dose concentration of PLD.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2561848|NCT02644278|Secondary|Part A: Minimum Observed Plasma Concentration During Dosing Interval (Cmin) of VX-984|Cmin is minimum observed plasma concentration obtained directly from the concentration versus time curve.|Pre-dose and at 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day -12 and Day 4 in Cycle 1; Pre-dose and at 0.5, 1, 2, 4 hours post-dose on Day 2 in Cycle 1 (each Cycle is of 28 days)|The Pharmacokinetic (PK) analysis included all participants who had received at least 1 dose of VX-984 or PLD and provided at least 1 measurable post dose concentration of VX-984 or one measurable post dose concentration of PLD.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561849|NCT02644278|Secondary|Part A: Time to Reach Maximum Plasma Concentration (Tmax) of VX-984|Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve.|Pre-dose and at 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day -12 and Day 4 in Cycle 1; Pre-dose and at 0.5, 1, 2, 4 hours post-dose on Day 2 in Cycle 1 (each Cycle is of 28 days)|The Pharmacokinetic (PK) analysis included all participants who had received at least 1 dose of VX-984 or PLD and provided at least 1 measurable post dose concentration of VX-984 or one measurable post dose concentration of PLD.|||hours||Full Range|Median
2561850|NCT02644278|Secondary|Part A: Maximum Observed Plasma Concentration (Cmax) of VX-984|Pharmacokinetic PK parameter Cmax was obtained directly from the concentration versus time curve.|Pre-dose and at 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day -12 and Day 4 in Cycle 1; Pre-dose and at 0.5, 1, 2, 4 hours post-dose on Day 2 in Cycle 1 (each Cycle is of 28 days)|The Pharmacokinetic (PK) analysis included all participants who had received at least 1 dose of VX-984 or PLD and provided at least 1 measurable post dose concentration of VX-984 or one measurable post dose concentration of PLD.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2561851|NCT02644278|Secondary|Part A: Area Under Plasma Concentration (AUC) During a Dosing Interval of VX-984|AUC is the area under the plasma concentration curve within 1 dosing interval.|Pre-dose and at 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day -12 and Day 4 in Cycle 1; Pre-dose and at 0.5, 1, 2, 4 hours post-dose on Day 2 in Cycle 1 (each Cycle is of 28 days)|The Pharmacokinetic (PK) analysis included all participants who had received at least 1 dose of VX-984 or PLD and provided at least 1 measurable post dose concentration of VX-984 or one measurable post dose concentration of PLD.|||nanogram hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2561852|NCT02644278|Primary|Part A: Maximum Tolerated Dose (MTD) of VX-984 in Combination With Pegylated Liposomal Doxorubicin (PLD)|The MTD was defined as the combination dose associated with the highest probability that Dose limiting toxicity (DLT) events will occur in 16.6 percent to less than 33.3 percent participants as the combination dose that not exceeded the overdose criterion (more than 25 percent probability that DLT events occurred less than or equal to (>=) 33 percent of participants. DLT was defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0.|Up to Cycle 1 Day 28 (each cycle is 28 days)|DLT evaluable set included all participants in the safety analysis set who either met the minimum exposure criterion and had sufficient safety evaluations (as determined by the Investigators and the Sponsor) or have had a DLT.|||milligram|||Number
2561853|NCT02644278|Primary|Part A: Number of Participants With Toxicity Grade 3 or Higher in Laboratory Abnormalities|The laboratory measurements included hematology and serum chemistry. It had been graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 into Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Life-threatening) and Grade 5 = death. Participants with grade 3 or higher were reported.|Baseline up to 28 days after the last dose of study treatment, assessed up to 53.1 weeks|The safety analysis set included all participants who had received at least 1 dose of the study treatment.|||Participants|||Count of Participants
2561854|NCT02644278|Primary|Part A: Number of Participants Who Experienced Dose Limiting Toxicity (DLT)|DLT was defined using National cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 as any of the following toxicities: Grade 4 neutropenia for more than 7 days; Grade greater than or equal to (>=) 3 febrile neutropenia; Grade 4 or Grade 3 thrombocytopenia with bleeding. Grade >= 3 uncontrolled nausea/vomiting and/or diarrhea despite adequate and optimal treatment and Grade >= 3 any non- hematological adverse event (AE), except the aforementioned gastrointestinal events and alopecia.|Cycle 1 (each cycle is 28 days)|DLT evaluable set included all participants in the safety analysis set who either met the minimum exposure criterion and had sufficient safety evaluations (as determined by the Investigators and the Sponsor) or have had a DLT.|||Participants|||Count of Participants
2561855|NCT02644278|Primary|Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-Emergent adverse events (TEAEs) were defined as AEs that were reported or worsened on or after the start of study drug dosing through the 28-day Safety Follow-up visit. TEAEs included both Serious TEAEs and non-serious TEAEs.|Baseline up to 28 days after the last dose of study treatment, assessed up to 53.1 weeks|The safety analysis set included all participants who had received at least 1 dose of the study treatment.|||Participants|||Count of Participants
2561856|NCT02644122|Secondary|To Assess Disease-related Patient-reported Outcomes Using the EORTC-QLQ-||4 years|||||||
2561857|NCT02644122|Secondary|To Assess the Effect of SF1126 on Overall Survival.||4 years|||||||
2561858|NCT02644122|Secondary|To Assess the Effect of SF1126 on Time to Progression.||4 years|||||||
2561859|NCT02644122|Secondary|Number of Participants With Treatment-related Adverse Events||4 years||||Participants|||Count of Participants
2561860|NCT02644122|Primary|To Determine ORR|best response of PR or CR observed within 6 months of enrollment|6 months|||||||
2561861|NCT02644109|Primary|Serum LDL Cholesterol||1 month||||mg/dl||Standard Deviation|Mean
2561862|NCT02644096|Primary|Change in Physical Dimensions in Health Status of Elderly Patients From 4 Weeks Pre Operatively to 9 Months Post Operatively After THR. Health Status is Measured by the Questionnaire Short-form 36 (SF-36).|"The health status was assessed by Short-Form 36 (SF-36) which is a self-administered generic questionnaire that has been shown to be reliable and valid for measuring functioning, well-being and general health status. The instrument measures the eight health dimensions listed in figure 3. Reflecting the impact of both dysfunctions and general health perception the questionnaire measures: physical function (PF), role physical (RF), bodily pain (BP), social function (SF) role emotional (RE), general health (GH), vitality (VT) and mental health (MH). The questions related to each dimension are scored on a scale from 0 (worst score) to 100 (best score).~All patients who had been consecutively admitted for THR were mailed an introduction letter together with a questionnaire containing a number and a prepaid return envelope. In the questionnaire they were asked to give demographic data and assess their health status"|Four weeks preoperatively and nine moths after discharge.|Patients who have completed the study and contributed with answers on the SF-36 questionnaire.|||Scores on SF-36 questionnaires||95% Confidence Interval|Mean
2561863|NCT02643979|Secondary|Time to Recovery|Monitored via the electronic medical record system as the time between the anesthesia end time and when the patient was safe for discharge from the hospital.|Day 1||||minutes||Standard Deviation|Mean
2561864|NCT02643979|Secondary|Number of Participants With Emergence Delirium|Number of participants with emergence delirium measured from the procedure end until time of discharge.|Day 1||||Participants|||Count of Participants
2561868|NCT02643979|Secondary|Number of Participants With Any Type of Airway Obstruction|The Anesthesiologist caring for the patient during the upper endoscopy made note of any obstructive events defined on a scale ranging from the patient audibly snoring (obstructing) to the patient obstructing and requiring assistance such as a chin lift or jaw thrust to relieve the obstruction and continue to move air adequately.|Day 1||||Participants|||Count of Participants
2561869|NCT02643979|Primary|Number of Participants With Gagging Reaction|"Number of participants with gagging or vomit-like reaction on endoscopic insertion"|Day 1||||Participants|||Count of Participants
2561870|NCT02643862|Secondary|Desensitization Measured to Increased Doses Measured by Proportion of FA Participants Who Pass a DBPCFC to 4,000 mg Each of 2 Allergens at Week 36|"Proportion of FA participants who pass a DBPCFC to 4,000 mg each of 2 allergens at week 36.~Greater than 3 foods at 36 weeks for~Xolair: 21/26 (80.8%) Placebo: 2/7 (28.6%)"|36 weeks|We analyzed an ITT|||Participants|||Count of Participants
2561871|NCT02643862|Primary|Desensitization Measured by Proportion of Food Allergic (FA) Participants Who Pass a DBPCFC to 2,000 mg Protein for Each of 2 Allergens at Week 36|"Proportion of food allergic (FA) participants who pass a DBPCFC to 2,000 mg protein for each of 2 allergens at week 36.~Xolair arm: 30/36 (83.3%) Placebo arm: 4/12 (33.3%)"|36 weeks|this is an ITT population|||Participants|||Count of Participants
2561872|NCT02643693|Primary|Overall Score of the Short Version of the Questionnaire of Smoking Urges (QSU-brief). Total Score; Factor 1 (Reward); Factor 2 (Relief)|"The QSU-Brief questionnaire is an instrument used to measure urge to smoke. Subjects were asked to respond to 10 questions, scored from 1 to 7 on a 7-point scale. A score of 1 on this scale indicates a very low urge to smoke, while a score of 7 indicates a very high urge to smoke. Subjects were asked to complete the questionnaire before, during, and after each ad libitum product use session. (P3L, VUSE, and Subjects' Own Brand of Non-menthol CC).~Two factor scores and a total score were derived. Factor 1 represents the desire and intention to smoke with smoking perceived as rewarding, while Factor 2 represents an anticipation of relief from negative effect with an urgent desire to smoke.~Products were compared over all timepoints using a repeated measure model using values after t0.~The model adjusted for baseline value, sequence, and period with repeated measure over time and a random effect in subjects. Adjusted mean over all timepoints, for each timepoint, were estimated."|QSU-brief questionnaire completed before product use session, then at 60 mins, 120 mins, and 180 mins after starting each product use session.|All the subjects who gave informed consent and completed all three ad libitum use sessions, without major protocol deviations.|||score on a scale||95% Confidence Interval|Least Squares Mean
2561873|NCT02643693|Primary|Change From Baseline Plasma Concentration of Nicotine/Cotinine After Each ad Libitum Use Session.|For each ad libitum use session (P3L, VUSE, and CC), change from baseline plasma concentration of Nicotine/Cotinine was measured from two blood samples collected before product use (to provide baseline measures) and from two blood samples collected following product use (to show change from baseline).|Measured at 15 minutes and 5 minutes prior to each 3 hour product use to provide baseline measures, then at 15 minutes and 30 minutes after product use period to show change from baseline.|All the subjects who gave informed consent and completed all three ad libitum use sessions, without major protocol deviations.|||(ng/mL)||95% Confidence Interval|Geometric Mean
2561874|NCT02643628|Primary|Number of Subjects With Adverse Events||6-months||||Participants|||Count of Participants
2561875|NCT02643628|Primary|Quality of Life Impact Scar (QOLIS)|Quality of Life Scar Impact Scale questionnaire was used to allow the subject to specifically address how acne scarring has affected his/her emotional and functional status. Subjects completed 33 questions ratings between 1 and 7 one being less severe 4 neutral and 7 more severe. Scores are averaged for a total range of 1-7.|6-months for the Treatment arm and 3 months for the Microneedling only arm||||units on a scale||Standard Deviation|Mean
2561876|NCT02643628|Primary|Subject Global Aesthetic Improvement Scale (SGAIS)|The SGAIS is used for the subject to rate the improvement of the acne scar. 5 point Likert Scale ranging from 5 to 1 with 5 = Much Improved and 1 = Much Worse|From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only arm|There were 21 subjects in the microneedling arm however data only available for 19 subjects|||units on a scale||Standard Deviation|Mean
2561877|NCT02643628|Primary|Physician Global Aesthetic Improvement Scale (PGAIS)|The PGAIS is used for the physician to rate the improvement of the acne scar. 5 point Likert Scale ranging from 5 to 1 with 5 = Much Improved and 1 = Much Worse|From week 12 to 6-months for the Treatment arm and 3 months for the Microneedling only arm|There were 21 subjects in the microneedling arm however data only available for 19 subjects|||units on a scale||Standard Deviation|Mean
2561878|NCT02643628|Primary|Acne Scar Assessment Scale (ASAS)|• Acne Scar Assessment Scale (ASAS): a validated 5-point static scale assessing physician impression of acne scar severity where as 1=clear and 5 = severe|6 months post-injection for Bellafill arm. 3 months Microneedling alone arm|All subjects|||units on a scale||Standard Deviation|Mean
2561879|NCT02643615|Secondary|Safety of Using SightSaver Visual Stimulator During Spine Prone Surgeries Under Balanced General Anesthesia Versus TIVA|Number of participants experiencing adverse events related to the study procedures during prone surgery and 24 hours after surgery under balanced general anesthesia versus TIVA|From start of surgery up to 24 hours after surgery||||Participants|||Count of Participants
2561880|NCT02643615|Secondary|The Difference in VEP Changes in Amplitude Among Both Groups|The difference in VEP changes in amplitude with a single and double stimuli using the SightSaver visual stimulator under balanced general anesthesia versus TIVA.|every 30 minutes during the entire procedure for up to 6 hours||||milliseconds (ms)||95% Confidence Interval|Mean
2561881|NCT02643615|Secondary|The Difference in VEP Changes in Amplitude Among Both Groups|VEP waveforms were evaluated using either present baseline - reproducible positive-negative-positive complex of substantial amplitude (≥2 µV) that appeared 100-200 ms after pulse stimulus onset; marginal Baseline - low amplitude (<2 µV) reproducible P100 waveform; or absent baseline - no repeatable response present. Any activity of <0.5 µV was not considered a response. Best derivation for each particular patient was used for monitoring electroretinogram (ERG) recording and confirming the stimulation.|Every 30 minutes during surgery for up to 6 hours||||micorvolts (µV)||95% Confidence Interval|Median
2561910|NCT02643082|Secondary|Airway Volume (iVaw)|iVaw represents the airway Volume, averaged across lobes, without correction for lung lobe volume|Day 15|ITT Population|||mL||95% Confidence Interval|Geometric Least Squares Mean
2561882|NCT02643615|Primary|Efficacy in Detecting Subtle Intraoperative VEP Changes Using SightSaver Visual Stimulator During Spine Prone Surgeries Under Balanced General Anesthesia Versus TIVA.|Number of Participants with Subtle Intraoperative VEP Changes Observed Using SightSaver Visual Stimulator During Spine Prone Surgeries Under Balanced General Anesthesia Versus TIVA|VEP waveforms recorded every 30 minutes during the entire procedure for up to 6 hours.||||Participants|||Count of Participants
2561883|NCT02643472|Secondary|Infant Developmental Status|Infant developmental status was measured using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley III). The Bayley III was administered between 11-13 months of study follow-up, and it used corrected infant age to account for prematurity. Composite scores for cognitive, language, and motor domains were determined and compared between groups. Bayley scores can range from 40-160, and higher scores indicate higher levels of infant development.|One year||||score on a scale||Standard Deviation|Mean
2561884|NCT02643472|Secondary|Infant Immunization Status|Infant immunization status was either provider-reported or accessed via a state registry. The number of neonates with a complete immunization series within 12 months after discharge were compared between groups. Complete immunization status was defined as receipt of 3 diphtheria tetanus acellular pertussis (DTaP) vaccines, 3 pneumococcal conjugate vaccines (PCV13), and either 2 or 3 Hemophilus influenzae b (HIB) vaccines, depending on vaccine type (e.g. PedvaxHIB at 2 and 4 months, ActHIB at 2, 4, and 6 months).|One year||||Participants|||Count of Participants
2561885|NCT02643472|Secondary|Hospitalizations|Infant hospitalizations were parent-reported and totaled over a period of 12 months.|One year||||Hospitalizations||Inter-Quartile Range|Median
2561886|NCT02643472|Secondary|ED Visits|Infant ED visits were parent-reported and totaled over a period of 12 months.|One year||||ED visits||Inter-Quartile Range|Median
2561887|NCT02643472|Secondary|Parental Depression|Parental depression was measured using the 10-item Center for Epidemiological Study Depression Scale (CES-D 10). Mean scores were determined and compared between groups. CES-D 10 scores can range from 0-30, and a score >=10 indicates the presence of depressive symptoms.|baseline; 1 month, 3 months, 6 months, 12 months after discharge||||score on a scale||95% Confidence Interval|Least Squares Mean
2561888|NCT02643472|Secondary|Parental Stress in the Neonatal Intensive Care Unit|The Parental Stressor Scale:Neonatal Intensive Care Unit (PSS:NICU) was used to measure NICU-specific stress. Mean total and subscale scores were determined using Metric 1 (applicable stress) and compared between groups. PSS:NICU scores can range from 1-5, and higher scores indicate higher levels of NICU-specific stress.|Baseline||||score on a scale||Standard Deviation|Mean
2561889|NCT02643472|Secondary|General Stress|General stress was measured using the Perceived Stress Scale (PSS-10), a 10-item instrument which asks respondents to consider their feelings and thoughts during the last month. Total scores range from 0-40, with higher scores indicating higher levels of stress|baseline, 1 week, 1 mo, 3 mo, 6 mo, 12 months after discharge||||score on a scale||95% Confidence Interval|Mean
2561890|NCT02643472|Secondary|Parental Stress|Parental stress was measured using the Parental Stress Scale (PSS). Mean scores were determined and compared between groups. PSS scores can range from 18-90, and higher scores indicate higher levels of parental stress.|baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge||||score on a scale||95% Confidence Interval|Least Squares Mean
2561891|NCT02643472|Secondary|Parental Anxiety|Parental anxiety was measured using the State Trait Anxiety Inventory (STAI). Mean scores were determined and compared between groups. The trait portion (Y-2) was only administered at baseline, while the state portion (Y-1) was administered at every interval and used for longitudinal analyses. STAI scores can range from 20-80, and higher scores indicate higher levels of anxiety.|baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge||||score on a scale||95% Confidence Interval|Least Squares Mean
2561892|NCT02643472|Primary|Parental Self-Efficacy|Parental self-efficacy was measured using the Perceived Maternal Parenting Self-Efficacy Questionnaire (PMPS-E). Mean scores were determined and compared between groups. PMPS-E scores can range from 20-80, and higher scores indicate higher levels of parental self-efficacy.|baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge||||score on a scale||95% Confidence Interval|Least Squares Mean
2561893|NCT02643394|Secondary|Morphine Equivalents of Postoperative Opioid Usage|Total amount of postoperative opioid usage at Postoperative Anesthesia Care Unit (PACU), an expected average of 6 hours|an expected average of 6 hours|Subjects undergoing Functional Endoscopic Sinus Surgery were enrolled to the study.|||Morphine equivalent (mg)||Inter-Quartile Range|Median
2561894|NCT02643394|Primary|Postoperative Pain Score on the Scale of 10 (0=No Pain and 10=Worst Pain)|Pain score on the scale of 10 at 1-h postoperatively in the Post-Anesthesia Care Unit (PACU)|1-h postoperatively|Subjects undergoing Functional Endoscopic Sinus Surgery were enrolled to the study.|||units on a scale||Inter-Quartile Range|Median
2561895|NCT02643355|Secondary|Clinical Opiate Withdrawal Scale Score at the Time of Disposition|"Opiate withdrawal scale score for all patients who received medication by one hour~The Clinical Opiate Withdrawal Scale (COWS) is an 11-item scale, ranging from 0 to 48 (5- 12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal).~This tool can be used to reproducibly rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. The summed score for the complete scale can be used to help clinicians determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids. The 11 items on the scale include scores rate the following symptoms: pulse rate, GI upset, sweating, tremor, restlessness, yawning, pupil size, anxiety, bone or joint aches, gooseflesh skin, runny nose."|Time of Disposition (on average within 6 hours)|Patients who had data available at the time of disposition|||units on a scale||Standard Deviation|Mean
2561896|NCT02643355|Secondary|Clinical Opiate Withdrawal Scale Score at 2 Hours Post Medication|"Opiate withdrawal scale score for all patients who received medication by one hour~The Clinical Opiate Withdrawal Scale (COWS) is an 11-item scale, ranging from 0 to 48 (5- 12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal).~This tool can be used to reproducibly rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. The summed score for the complete scale can be used to help clinicians determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids. The 11 items on the scale include scores rate the following symptoms: pulse rate, GI upset, sweating, tremor, restlessness, yawning, pupil size, anxiety, bone or joint aches, gooseflesh skin, runny nose."|2 hours|Patients who had data available at 2 hours|||units on a scale||Standard Deviation|Mean
2561897|NCT02643355|Secondary|Clinical Opiate Withdrawal Scale Score at 1 Hour Post Medication|"Opiate withdrawal scale score for all patients who received medication by one hour~The Clinical Opiate Withdrawal Scale (COWS) is an 11-item scale, ranging from 0 to 48 (5- 12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal).~This tool can be used to reproducibly rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. The summed score for the complete scale can be used to help clinicians determine the stage or severity of opiate withdrawal and assess the level of physical dependence on opioids. The 11 items on the scale include scores rate the following symptoms: pulse rate, GI upset, sweating, tremor, restlessness, yawning, pupil size, anxiety, bone or joint aches, gooseflesh skin, runny nose."|At 1 hour|Patients who had COWs score calculated at 1 hour|||units on a scale||Standard Deviation|Mean
2561898|NCT02643355|Primary|Number of Participants That Received Rescue Medication for Withdrawal Symptoms Within 1 Hour|Rescue Medication (additional medications given for symptoms) within 1 hour of medication administration|1 Hour|Patients who received medication within 1 hour|||Participants|||Count of Participants
2561899|NCT02643251|Secondary|Mean Daily Worst Pain Intensity Numeric Pain Rating Scale Scores|"The Numeric Pain Rating Scale is a single reading that measures the patients interpretation of their pain on a scale from 0, no pain to 10, worst pain imaginable. The change from baseline can range from -10 to 10. The change from Baseline (worse score from Day -14 to Day -8) to End-of-Treatment (worse score during Days 78 to 84 [±3 days]) in the Numeric Pain Rating Scale score assessing the worse pain in the past 24 hours in the painful areas of the feet from Days 78 to 84 compared to the 7 days at the Baseline Phase (Days -14 to -8). For the primary efficacy endpoint, the mean change in pain intensity from Baseline to Week 12 was analyzed using an analysis of covariance (ANCOVA) model with the Baseline pain intensity score serving as a covariate. The statistical model also included treatment, site, site by treatment interaction, and strata. If the site by treatment interaction term was not significant at the 0.1 level, then it was excluded from the model."|The change from Baseline (worse over Day -14 to Day -8) to End-of-Treatment (worse over Days 78 to 84 [±3 days])||||units on a scale||Standard Deviation|Mean
2561900|NCT02643251|Primary|Change From Baseline to Day 84 (Week 12) in Numeric Pain Rating Scale Score|"The Numeric Pain Rating Scale is a single reading that measures the patients interpretation of their pain on a scale from 0, no pain to 10, worst pain imaginable. The change from baseline can range from -10 to 10. The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days]) in the Numeric Pain Rating Scale score assessing the average pain in the past 24 hours in the painful areas of the feet averaged over Days 78 to 84 compared to the 7 days at the Baseline Phase (Days -14 to -8). For the primary efficacy endpoint, the mean change in pain intensity from Baseline to Week 12 was analyzed using an analysis of covariance (ANCOVA) model with the Baseline pain intensity score serving as a covariate. The statistical model also included treatment, site, site by treatment interaction, and strata. If the site by treatment interaction term was not significant at the 0.1 level, then it was excluded from the model."|The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days])||||units on a scale||Standard Deviation|Mean
2561901|NCT02643225|Primary|The Number of Participants Who Were Diagnosed With Fetal Macrosomia (Birth Weight)|The neonates will be weighed and fetal macrosomia will be diagnosed if fetal weight is 4 kg or more.|at birth|The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee.|||participants|||Number
2561902|NCT02643225|Secondary|Interventricular Septum Thickness|The interventricular septum thickness will be measured by ultrasound examination|36-37 weeks of gestation|The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee.|||mm||Standard Deviation|Mean
2561903|NCT02643225|Secondary|Prediction of Fetal Macrosomia by Measuring HbA1C in Participants|Venous blood samples will be taken from participants in clinical pathology department Ain Shams University, to measure the level of HbA1c using immunoassay technique.|36-37 weeks of gestation|The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee|||percentage of glycosolated hemoglobin||Standard Deviation|Mean
2561904|NCT02643225|Secondary|Umbilical Cordcross-sectional Area|the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device.|36-37 weeks of gestation|The patients will be divided into two groups, 40 pregnant women as case group with gestational diabetes mellitus and 40 non diabetic pregnant women as control group after being approved by the local hospital ethics and research committee|||cm^2||Standard Deviation|Mean
2561905|NCT02643199|Secondary|Number of Satisfactory Fetal Echocardiography Views by Five-Dimensional Ultrasound|"Fetal Echocardiography by Five-Dimensional Ultrasound measurement was done to examine fetal heart in both sagittal Views and transverse views:~Four chamber view~Five chamber view~Left outflow tract~Right outflow tract~3 vessels and Trachea View~Abdomen/Stomach~Ductal arch~aortic arch~Bicaval view then we count howmuch views of nine views were satisfactory"|20 - 36 weeks of gestation||||Number of satisfactory views||Standard Deviation|Mean
2561906|NCT02643199|Primary|Number of Satisfactory Fetal Echocardiography Views by Two-Dimensional Ultrasound|"Fetal Echocardiography by Two-Dimensional Ultrasound measurement was done to examine fetal heart in both sagittal Views and transverse views:~Four chamber view~Five chamber view~Left outflow tract~Right outflow tract~3 vessels and Trachea View~Abdomen/Stomach~Ductal arch~aortic arch~Bicaval view then we count howmuch views of nine views were satisfactory"|20 - 36 weeks of gestation||||Number of satisfactory views||Standard Deviation|Mean
2561907|NCT02643095|Primary|The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses|The primary endpoint of the study is the overall satisfaction and desire to continue wearing the study lenses as measured by a psychometric questionnaire at the completion of the study.|1 month after lens is dispensed||||Participants|||Count of Participants
2561908|NCT02643082|Secondary|Change From Baseline in FRC (L) at Day 15|Change from baseline in Functional Residual Capacity|Baseline and Day 15|ITT Population|||Liters||95% Confidence Interval|Geometric Least Squares Mean
2561916|NCT02643004|Secondary|Lens Surface - Debris|Lens debris for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|1 week|A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.|||percentage of subjects|||Number
2561917|NCT02643004|Secondary|Lens Surface - Debris|Lens debris for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline||||percentage of subjects|||Number
2561918|NCT02643004|Secondary|Lens Surface - Deposition|Lens surface for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|1 week|A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.|||percentage of subjects|||Number
2561919|NCT02643004|Secondary|Lens Surface - Deposition|Lens surface for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline||||percentage of subjects|||Number
2561920|NCT02643004|Secondary|Visual Acuity|Measurement of visual acuity (VA) for senofilcon A and stenfilcon A assessed at baseline and 1 week using logMAR VA chart.|Baseline and 1 week|Protocol deviations occurred and therefore resulted in incomplete data sets.|||LogMAR||Standard Deviation|Mean
2561921|NCT02643004|Secondary|Lens Movement|Lens movement assessed for stenfilcon A and senofilcon A at 1 week using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.|1 Week|A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.|||percentage of subjects|||Number
2561922|NCT02643004|Secondary|Lens Movement|Lens movement assessed for stenfilcon A and senofilcon A at baseline using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.|Baseline||||percentage of subjects|||Number
2561923|NCT02643004|Secondary|Vertical Centration|Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal|1 Week|A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.|||percentage of subjects|||Number
2561924|NCT02643004|Secondary|Vertical Centration|Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal|Baseline||||percentage of subjects|||Number
2561925|NCT02643004|Secondary|Horizontal Centration|Lens fit, horizontal centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal|1 Week|A protocol deviation occurred for 2 participants and therefore resulted in incomplete data sets.|||percentage of subjects|||Number
2561926|NCT02643004|Secondary|Horizontal Centration|Lens fit, horizontal centration will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal|Baseline||||percentage of subjects|||Number
2561927|NCT02643004|Primary|Vision|Subjective responses for vision will be evaluated for each pair using questionnaire. Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent.|Baseline and 1 week|A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.|||units on a scale||Standard Deviation|Mean
2561928|NCT02643004|Primary|Dryness|Subjective responses for dryness will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness.|1 week|A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.|||units on a scale||Standard Deviation|Mean
2561929|NCT02643004|Primary|Comfort|Subjective responses for comfort will be evaluated for each pair using questionnaire. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.|Baseline and 1 week|A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.|||units on a scale||Standard Deviation|Mean
2561930|NCT02643004|Primary|Overall Subjective Score of Lenses|Subjective responses will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, 100=excellent.|Baseline and 1 week|A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.|||units on a scale||Standard Deviation|Mean
2561931|NCT02643004|Primary|Ocular Physiology|Ocular physiology assessment of senofilcon A and stenfilcon A lenses by biomicroscopy for the following: corneal staining, conjunctival hyperaemia, limbal hyperaemia, and conjunctival staining. Scale 0-4, 0.25 steps, 0=normal, 4=severe.|Baseline and 1 week|Protocol deviations occurred for 2 participants and therefore resulted in incomplete data sets.|||units on a scale||Standard Deviation|Mean
2561932|NCT02642965|Other Pre-specified|Change in Micro Ribonucleic Acid (miRNA) Using TaqMan miRNA Assays|Plasma miR-29b and -499 fold change from pre-treatment baseline will be determined at each post-treatment time point using the delta-delta-Ct method. The relationship between 6-hour miR-29b and -499 expression and change in left ventricular global longitudinal strain between the pre-cycle and end of cycle 1 echocardiograms will be determined by calculating a Spearman correlation coefficient.|Baseline up to day 30|||||||
2561933|NCT02642965|Other Pre-specified|Change in in Global Longitudinal Strain|A paired t-test will be used to compare the mean global longitudinal strain between the pre-treatment (at relapse) baseline and post-course 1 echocardiogram.|Baseline up to 28 days|||||||
2561934|NCT02642965|Other Pre-specified|Change in High Sensitive C-reactive Protein (HS-CRP) Levels|Spearman correlation coefficients will be used to correlate the post-treatment values of HS-CRP with previous cumulative anthracycline dose prior to liposome-encapsulated daunorubicin-cytarabine, change in ejection fraction between pre- and post-liposome-encapsulated daunorubicin-cytarabine baseline assessed by echocardiogram before and after course 1, and change in in global longitudinal strain.|Baseline up to day 30|||||||
2561935|NCT02642965|Other Pre-specified|Change in N-terminal Pro B-type Natriuretic Peptide (NT-BNP) Levels|Spearman correlation coefficients will be used to correlate the post-treatment values of NT-BNP with previous cumulative anthracycline dose prior to liposome-encapsulated daunorubicin-cytarabine, change in ejection fraction between pre- and post-liposome-encapsulated daunorubicin-cytarabine baseline assessed by echocardiogram before and after course 1, and change in in global longitudinal strain.|Baseline up to day 30|||||||
2561936|NCT02642965|Other Pre-specified|Change in Troponin Levels|Spearman correlation coefficients will be used to correlate the post-treatment values of troponin with previous cumulative anthracycline dose prior to liposome-encapsulated daunorubicin-cytarabine, change in ejection fraction between pre- and post-liposome-encapsulated daunorubicin-cytarabine baseline assessed by echocardiogram before and after course 1, and change in global longitudinal strain.|Baseline up to day 30|||||||
2561937|NCT02642965|Other Pre-specified|Proportion of Patients Experiencing Toxicities|Proportion of patients experiencing >= grade 3 non-hematologic toxicities, cardiac toxicities, and infections by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.|Up to 8 weeks post-treatment|||||||
2561938|NCT02642965|Other Pre-specified|Time to Peripheral Blood Cell Count Recovery|Descriptive statistics will be used to summarize peripheral blood cell count recovery.|Up to 1 year|||||||
2561939|NCT02642965|Other Pre-specified|Time to Bone Marrow Count Recovery|Descriptive statistics will be used to summarize bone marrow count recovery.|Up to 1 year|||||||
2561940|NCT02642965|Other Pre-specified|Length of Hospitalization Time|Descriptive statistics will be used to summarize length of hospitalization time.|Up to 1 year|||||||
2561941|NCT02642965|Secondary|Liposome-encapsulated Cytarabine Area Under the Curve|Geometric mean liposome-encapsulated cytarabine area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration will be determined for patients in the dose-finding phase.|Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1|Patients in the efficacy phase excluded (n=32). 1 dose finding patient excluded because dose record was not consistent with treatment plan.|||(NANOGRAM x HOUR) / MILLILITER||Full Range|Geometric Mean
2561942|NCT02642965|Secondary|Liposome-encapsulated Cytarabine Time of Maximum Concentration|Median liposome-encapsulated cytarabine time of maximum observed plasma concentration will be determined for patients in the dose-finding phase.|Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1|Patients in the efficacy phase excluded (n=32). 1 dose finding patient excluded because dose record was not consistent with treatment plan.|||HOUR||Full Range|Median
2561943|NCT02642965|Secondary|Liposome-encapsulated Cytarabine Volume of Distribution|Geometric mean liposome-encapsulated cytarabine volume of distribution following IV infusion will be determined for patients in the dose-finding phase.|Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1|Patients in the efficacy phase excluded (n=32). 1 dose finding patient excluded because dose record was not consistent with treatment plan.|||MILLILITER||Full Range|Geometric Mean
2561944|NCT02642965|Secondary|Liposome-encapsulated Cytarabine Clearance|Geometric mean liposome-encapsulated cytarabine clearance following IV infusion will be determined for patients in the dose-finding phase.|Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1|Patients in the efficacy phase excluded (n=32). 1 dose finding patient excluded because dose record was not consistent with treatment plan.|||MILLILITER / HOUR||Full Range|Geometric Mean
2561945|NCT02642965|Secondary|Liposome-encapsulated Daunorubicin Area Under the Curve|Geometric mean liposome-encapsulated daunorubicin area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration will be determined for patients in the dose-finding phase.|Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1|Patients in the efficacy phase excluded (n=32). 1 dose finding patient excluded because dose record was not consistent with treatment plan.|||(NANOGRAM x HOUR) / MILLILITER||Full Range|Geometric Mean
2561946|NCT02642965|Secondary|Liposome-encapsulated Daunorubicin Time of Maximum Concentration|Median liposome-encapsulated daunorubicin time of maximum observed plasma concentration will be determined for patients in the dose-finding phase.|Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1|Patients in the efficacy phase excluded (n=32). 1 dose finding patient excluded because dose record was not consistent with treatment plan.|||HOUR||Full Range|Median
2561947|NCT02642965|Secondary|Liposome-encapsulated Daunorubicin Volume of Distribution|Geometric mean liposome-encapsulated daunorubicin volume of distribution following IV infusion will be determined for patients in the dose-finding phase.|Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1|Patients in the efficacy phase excluded (n=32). 1 dose finding patient excluded because dose record was not consistent with treatment plan.|||MILLILITER||Full Range|Geometric Mean
2561948|NCT02642965|Secondary|Liposome-encapsulated Daunorubicin Clearance|Geometric mean liposome-encapsulated daunorubicin clearance following IV infusion will be determined for patients in the dose-finding phase.|Prior to infusion on day 5 and, 45 and 90 minutes post day 5 infusion of cycle 1|Patients in the efficacy phase excluded (n=32). 1 dose finding patient excluded because dose record was not consistent with treatment plan.|||MILLILITER / HOUR||Full Range|Geometric Mean
2561949|NCT02642965|Secondary|Percentage of Responders (Complete Response or Complete Remission With Partial or Incomplete Platelet Recovery) After First Cycle of Therapy|Response (complete response or complete remission with partial or incomplete platelet recovery) after first cycle of therapy, where response is assessed using the revised Acute Myeloid Leukemia International Working Group Criteria. Percentage of responders is calculated by the total of number of patients with complete response or complete remission with partial or incomplete platelet recovery divided by the number of patients evaluable for response after the first cycle. 95% confidence interval is determined using a binomial exact method.|Up to 4 weeks|1 patient among the 38 eligible patients was not evaluable for response.|||Percentage of responders||95% Confidence Interval|Number
2561950|NCT02642965|Primary|Percentage of Responders (Complete Response or Complete Remission With Partial Platelet Recovery) After up to 2 Cycles|Best response (complete response or complete remission with partial platelet recovery) after up to 2 cycles of therapy, where response is assessed using the revised Acute Myeloid Leukemia International Working Group Criteria. Percentage of responders is calculated using the methods of Jung and Kim. 90% confidence interval is determined using the methods of Koyama and Chen.|Up to 8 weeks|1 patient among the 38 eligible patients was not evaluable for response.|||Percantage of best responders||90% Confidence Interval|Number
2561951|NCT02642965|Primary|Number of Participants With a Dose-limiting Toxicity|Number of patients in the dose-finding phase with a dose-limiting toxicity, graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.|28 days|First 6 patients evaluable for dose limiting toxicity (DLT).|||Participants|||Count of Participants
2561959|NCT02642835|Secondary|Number of Participants Who Needed Surgical Mesh Removal for Erosion|A mesh erosion is when the body rejects the mesh and it is visible in the vagina rather than being buried under the vaginal epithelium. clinic visit|1 hour||||Participants|||Count of Participants
2561960|NCT02642835|Secondary|Number of Participants Who Rated Their Improvement as Better or Very Much Better|The patient global impression of Improvement scale (PGI-I) is a global improvement scale filled out by the patient. It is graded as very much better, much better, a little better. no change, a little worse, much worse or very much worse.clinic visit|1 hour||||Participants|||Count of Participants
2561961|NCT02642835|Secondary|Number of Participants Who Developed New Stress Incontinence|The mesh has caused the prolapse to be successfully repaired but the patient has developed stress incontinence as a separate issue. clinic visit|1 hour||||Participants|||Count of Participants
2561962|NCT02642835|Secondary|Number of Participants Who Underwent Reoperation for Prolapse in a Different Compartment|This is where the mesh has held up and there is no prolapse where it was inserted. This measure refers to when a different part of the vagina has prolapsed.|1 hour||||Participants|||Count of Participants
2561963|NCT02642835|Secondary|Number of Participants Requiring Treatment for Recurrent Prolapse - Prolapse in the Same Part of the Vagina|clinic visit; number of participants who underwent reoperation of recurrent prolapse in the same compartment|1 hour||||Participants|||Count of Participants
2561964|NCT02642835|Secondary|Number of Participants Complaining of a Bulge. Recurrent Prolapse|"Efficacy determined by the question in the pelvic floor prolapse distress inventory usually have a bulge or something falling out that you can see or feel in your vaginal area. Determined at clinic visit by questioning"|1 hour||||Participants|||Count of Participants
2561965|NCT02642835|Secondary|Number of Participants With no Physical Evidence of Recurrent Prolapse as Determined by Physical Examination|"The presence of less than stage 2 prolapse (eg stage 1) anterior wall prolapse determined as anatomical success. A stage one prolapse is higher than 1cm above the vaginal entrance.~A stage 2 prolapse means that the leading edge of the prolapse is between 1cm above the entrance to the vagina up to 1cm below the entrance to the vagina."|1 hour||||Participants|||Count of Participants
2561966|NCT02642835|Primary|The Number of Participants With a Current Mesh Erosion or Treated for a Mesh Erosion Since Inserted|clinic visit. 5 patients were interviewed by phone and were not examined - hence this figure is out of 43 not 48.|1 hour||||Participants|||Count of Participants
2561967|NCT02642679|Secondary|Wound Healing Quality|Assessed using the Vancouver scar scale (VSS) 1-month post-operatively. The VSS is a widely used scale in clinical practice to document change in scar appearance. The scale scores four parameters: pigmentation, vascularity, pliability, and height for a total of 13 points. Normal appearance in each of the parameters garners a score of 0 and scores get higher (2-3) as an increase in parameters is observed. The lower the score, the better the outcome.|Assessed up to 1 month of use||||units on a scale||Standard Deviation|Mean
2561968|NCT02642679|Primary|Wound Healing Rate (Re-epithelialization)|The extent of re-epithelialization was evaluated by the surgeon and a blinded expert using photographs taken on days 10-14 and at 1 month postoperatively.|Assessed up to 1 month postoperatively.||||percent (%)||Standard Deviation|Mean
2561969|NCT02642679|Primary|Pain|Pain reported by Subject using a visual analog scale (VAS). This scale measures an unidimensional measure of pain intensity by means of a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length. The left side of the scale signifies no pain (score of 0), and the right side the other extreme, worst pain imaginable (score of 10). Patients are asked to place a line perpendicular to the VAS scale at the point that represents their pain intensity.|Assessed up to 14 days of use|Pain was evaluated on postoperative day 1, before the dressing was changed on days 5-7, and before and after dressing removal on days 10-14 using the Visual Analog Scale (VAS). The patient was asked to mark his/her pain level on the line between the two endpoints.|||units on a scale||Standard Deviation|Mean
2561970|NCT02642653|Primary|Expressive Language Sample Composite Score in the Home|The primary outcome reflects the diversity of vocabulary used. Higher scores reflect more skill. The lowest possible value is zero. No theoretical maximum can be defined because the wordless picture books can lead to a large and indeterminate set of options for the amount of talk and the vocabulary used. In a previous study of a nonpharmacological intervention, the range at baseline was 9-177, and at post-treatment, the range for the combined treated and nontreated groups was 23-214, although these values were not corrected for the number of C-units produced (McDuffie at el. 2018 Developmental Neurorehabilitation).|20 weeks||||score on a scale||Standard Deviation|Mean
2561971|NCT02642653|Secondary|Visual Analog Scale (VAS) - Social Impairment|"The measure was used to assess parental impressions of progress in two key symptoms: spoken language impairment and social impairment. The distance of the mark from one end is used as the outcome variable for analysis. Caregivers mark on a visual line measuring 10 cm with worst behavior at 0 cm and best behavior at 10 cm. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the 10-weeks and 20-weeks visits. The calculated distance in cm between the marks drawn at the baseline and follow-up visits thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the worst behavior side for the Social Impairment scale, at 20-weeks. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm."|20-weeks||||centimeters||Standard Deviation|Mean
2561972|NCT02642653|Secondary|Visual Analog Scale (VAS) - Social Impairment|"The measure was used to assess parental impressions of progress in two key symptoms: spoken language impairment and social impairment. The distance of the mark from one end is used as the outcome variable for analysis. Caregivers mark on a visual line measuring 10 cm with worst behavior at 0 cm and best behavior at 10 cm. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the 10-weeks and 20-weeks visits. The calculated distance in cm between the marks drawn at the baseline and follow-up visits thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the worst behavior side for the Social Impairment scale, at 10-weeks. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm."|10-weeks||||centimeters||Standard Deviation|Mean
2564520|NCT02608099|Other Pre-specified|Number of Patients With TIAs or Non-Hemorrhagic Strokes|Number of Patients who had TIAs or non-hemorrhagic strokes.|Enrollment to 1 month post catheter ablation||||Participants|||Count of Participants
2561973|NCT02642653|Secondary|Visual Analog Scale (VAS) - Social Impairment|"The measure was used to assess parental impressions of progress in two key symptoms: spoken language impairment and social impairment. The distance of the mark from one end is used as the outcome variable for analysis. Caregivers mark on a visual line measuring 10 cm with worst behavior at 0 cm and best behavior at 10 cm. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the 10-weeks and 20-weeks visits. The calculated distance in cm between the marks drawn at the baseline and follow-up visits thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the worst behavior side for the Social Impairment scale, at baseline. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm."|Baseline||||centimeters||Standard Deviation|Mean
2561974|NCT02642653|Secondary|Visual Analog Scale (VAS) - Spoken Language Impairment|"The measure was used to assess parental impressions of progress in two key symptoms: spoken language impairment and social impairment. The distance of the mark from one end is used as the outcome variable for analysis. Caregivers mark on a visual line measuring 10 cm with worst behavior at 0 cm and best behavior at 10 cm. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the 10-weeks and 20-weeks visits. The calculated distance in cm between the marks drawn at the baseline and follow-up visits thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the worst behavior side for the Spoken Language Impairment scale, at 20-weeks. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm."|20 weeks||||centimeters||Standard Deviation|Mean
2561975|NCT02642653|Secondary|Visual Analog Scale (VAS) - Spoken Language Impairment|"The measure was used to assess parental impressions of progress in two key symptoms: spoken language impairment and social impairment. The distance of the mark from one end is used as the outcome variable for analysis. Caregivers mark on a visual line measuring 10 cm with worst behavior at 0 cm and best behavior at 10 cm. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the 10-weeks and 20-weeks visits. The calculated distance in cm between the marks drawn at the baseline and follow-up visits thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the worst behavior side for the Spoken Language Impairment scale, at 10-weeks. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm."|10 weeks||||centimeters||Standard Deviation|Mean
2561976|NCT02642653|Secondary|Visual Analog Scale (VAS) - Spoken Language Impairment|"The measure was used to assess parental impressions of progress in two key symptoms: spoken language impairment and social impairment. The distance of the mark from one end is used as the outcome variable for analysis. Caregivers mark on a visual line measuring 10 cm with worst behavior at 0 cm and best behavior at 10 cm. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the 10-weeks and 20-weeks visits. The calculated distance in cm between the marks drawn at the baseline and follow-up visits thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the worst behavior side for the Spoken Language Impairment scale, at baseline. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm."|Baseline||||centimeters||Standard Deviation|Mean
2561977|NCT02642653|Secondary|Clinical Global Impression-Improvement (CGI-I) Scale|A clinician rated scale utilizing history from the parents or caregiver and incorporating it into a clinical rating to assess for overall therapeutic response. The 7-point scale ranges from: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; and 7 = Very much worse. Therefore, the lower the score, the greater the overall improvement as rated by the clinician. The CGI-I was used at the 10 week and 20 week visits. Shown here are the CGI-I mean scores from the 20-weeks end-of-study visit.|20 weeks||||units on a scale||Standard Deviation|Mean
2561978|NCT02642653|Secondary|Clinical Global Impression-Improvement (CGI-I) Scale|A clinician rated scale utilizing history from the parents or caregiver and incorporating it into a clinical rating to assess for overall therapeutic response. The 7-point scale ranges from: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; and 7 = Very much worse. Therefore, the lower the score, the greater the overall improvement as rated by the clinician. The CGI-I was used at the 10 week and 20 week visits. Shown here are the CGI-I mean scores from the 10-weeks end-of-study visit.|10 weeks||||units on a scale||Standard Deviation|Mean
2561979|NCT02642653|Secondary|Clinical Global Impression- Severity (CGI-S)|A clinician rated scale utilizing history from the parents or caregiver and incorporating it into a clinical rating for severity. The CGI-S was used at the pre-treatment assessment to judge symptom severity. The 7-point scale ranges from: 1 = Normal; 2 = Borderline Ill; 3 = Mildly Ill; 4 = Moderately Ill; 5 = Markedly Ill; 6 = Severely Ill; and 7 = Extremely Ill. Therefore, the higher the score, the greater the severity of the patient's illness. Shown here are the CGI-S mean scores from the baseline visit.|Baseline||||units on a scale||Standard Deviation|Mean
2561980|NCT02642653|Secondary|FXS- Normed Aberrant Behavior Checklist (ABC) Social Avoidance Subscale|The ABC-C is a 58-item caregiver-rated behavior scale used to examine treatment effects on challenging behaviors for individuals with FXS in the following domains: (1) irritability; (2) lethargy/social withdrawal; (3) stereotypic behavior; (4) hyperactivity; and (5) inappropriate speech. Caregiver rates the subject's behavior as follows: 0 = not a problem, l = the behavior is a problem but slight in degree, 2 = the problem is moderately serious, 3 = the problem is severe in degree. Sansone et al. (2012) further subdivided social withdrawal to rate social avoidance in FXS. The subscale includes 4 items which were originally part of the Lethargy/Withdrawal subscale. This subscale captures core aspects of the FXS phenotype related to gaze avoidance, social ''escape'' behaviors, and social anxiety. Subscale score ranges from 0 to 12, higher scores reflect a more problematic behavior. Shown are the ABC social avoidance subscale mean scores from the 20-weeks end-of-study visit.|20 weeks||||score on a scale||Standard Deviation|Mean
2561992|NCT02642614|Secondary|Change in Absolute Number of Neutrophil in Sputum at the End of the Planned Treatment Period|Change in Absolute Number of Neutrophil in Sputum at the end of the planned treatment period|28 days|Treated set including participants with available data for the endpoint percent change in absolute number of neutrophil in sputum at the end of the planned treatment period|||10^6 cells/ milliliter (mL)||Standard Error|Mean
2561981|NCT02642653|Secondary|FXS- Normed Aberrant Behavior Checklist (ABC) Social Avoidance Subscale|The ABC-C is a 58-item caregiver-rated behavior scale used to examine treatment effects on challenging behaviors for individuals with FXS in the following domains: (1) irritability; (2) lethargy/social withdrawal; (3) stereotypic behavior; (4) hyperactivity; and (5) inappropriate speech. Caregiver rates the subject's behavior as follows: 0 = not a problem, l = the behavior is a problem but slight in degree, 2 = the problem is moderately serious, 3 = the problem is severe in degree. Sansone et al. (2012) further subdivided social withdrawal to rate social avoidance in FXS. The subscale includes 4 items which were originally part of the Lethargy/Withdrawal subscale. This subscale captures core aspects of the FXS phenotype related to gaze avoidance, social ''escape'' behaviors, and social anxiety. Subscale score ranges from 0 to 12, higher scores reflect a more problematic behavior. Shown here are the ABC social avoidance subscale mean scores from the 10-weeks follow-up visit.|10 weeks||||score on a scale||Standard Deviation|Mean
2561982|NCT02642653|Secondary|FXS- Normed Aberrant Behavior Checklist (ABC) Social Avoidance Subscale|The ABC-C is a 58-item caregiver-rated behavior scale used to examine treatment effects on challenging behaviors for individuals with FXS in the following domains: (1) irritability; (2) lethargy/social withdrawal; (3) stereotypic behavior; (4) hyperactivity; and (5) inappropriate speech. Caregiver rates the subject's behavior as follows: 0 = not a problem, l = the behavior is a problem but slight in degree, 2 = the problem is moderately serious, 3 = the problem is severe in degree. Sansone et al. (2012) further subdivided social withdrawal to rate social avoidance in FXS. The subscale includes 4 items which were originally part of the Lethargy/Withdrawal subscale. This subscale captures core aspects of the FXS phenotype related to gaze avoidance, social ''escape'' behaviors, and social anxiety. Subscale score ranges from 0 to 12, higher scores reflect a more problematic behavior.|Baseline||||score on a scale||Standard Deviation|Mean
2561983|NCT02642653|Primary|Expressive Language Sample Composite Score in the Home|The primary outcome reflects the diversity of vocabulary used. Higher scores reflect more skill. The lowest possible value is zero. No theoretical maximum can be defined because the wordless picture books can lead to a large and indeterminate set of options for the amount of talk and the vocabulary used. In a previous study of a nonpharmacological intervention, the range at baseline was 9-177, and at post-treatment, the range for the combined treated and nontreated groups was 23-214, although these values were not corrected for the number of C-units produced (McDuffie at el. 2018 Developmental Neurorehabilitation).|Baseline||||score on a scale||Standard Deviation|Mean
2561984|NCT02642627|Secondary|Adverse Events|Throughout the course of the study, all AEs will be monitored and reported through the CRF. All AEs occurring after study device administration were followed until the event has resolved or stabilized or until follow-up was no longer possible.|month 7||||adverse events|||Number
2561985|NCT02642627|Primary|Change on the Acne Scar Assessment Scale (ASAS)|"A validated 5-point static scale assessing physician impression of acne scar severity. The total range on the scale is 1-5 (1= Clear and 5 = Severe) Clear: No depressions are seen in the treatment area. Macular discoloration may be seen.~Very Mild: A single depression is easily noticeable with direct lighting (deep). Most or all of the depressions seen are only readily apparent with tangential lighting (shallow).~Mild: A few to several, but less than half of all the depressions are easily noticeable with direct lighting (deep). Most of the depressions seen are only readily apparent with tangential lighting (shallow).~Moderate: More than half of the depressions are apparent with direct lighting (deep).~Severe: All or almost all the lesions can be seen with direct lighting (deep)"|Month 1, 4 and 7|The overall number of participants was all subjects enrolled in the clinical trial. The number analyzed includes the number of participants with available data for each time point.|||units on a scale||Standard Deviation|Mean
2561986|NCT02642614|Secondary|Area Under the Concentration-time Curve of BI 1026706 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUC Tau, ss) After the Last Dose (Morning of Day 28)|Area under the concentration-time curve of BI 1026706 in plasma at steady state over a uniform dosing interval tau (AUC tau, ss) after the last dose (morning of Day 28)|-0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.|ePKS including participants with available data for this endpoint|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2561987|NCT02642614|Secondary|Time From Dosing to Maximum Concentration of BI 1026706 in Plasma (Tmax, ss) After the Last Dose (Morning of Day 28)|Time from dosing to maximum concentration of BI 1026706 in plasma (Tmax, ss) after the last dose (morning of Day 28)|-0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.|ePKS including participants with available data for this endpoint|||hour||Full Range|Median
2561988|NCT02642614|Secondary|Maximum Measured Concentration of BI 1026706 in Plasma at Steady State Over a Uniform Dosing Interval Tau (Cmax, ss) After the Last Dose (Morning of Day 28)|Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau (Cmax, ss) after the last dose (morning of Day 28)|-0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.|ePKS including participants with available data for this endpoint|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2561989|NCT02642614|Secondary|Area Under the Concentration-time Curve of BI 1026706 in Plasma (AUC 0-12h) After the First Dose (Morning of Day 1)|Area under the concentration-time curve of BI 1026706 in plasma (AUC 0-12h) after the first dose (morning of Day 1)|-0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.|ePKS|||nanomoles (nmol) * hour (h) / litre (L)||Geometric Coefficient of Variation|Geometric Mean
2561990|NCT02642614|Secondary|Time From Dosing to Maximum Concentration of BI 1026706 in Plasma (Tmax) After the First Dose (Morning of Day 1)|Time from dosing to maximum concentration of BI 1026706 in plasma (Tmax) after the first dose (morning of Day 1)|-0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.|ePKS|||hour||Full Range|Median
2561991|NCT02642614|Secondary|Maximum Measured Concentration of BI 1026706 in Plasma (Cmax) After the First Dose (Morning of Day 1)|Maximum measured concentration of BI 1026706 in plasma (Cmax) after the first dose (morning of Day 1)|-0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.|Extensive pharmacokinetic set (ePKS): The ePKS included all patients in the PKS who signed the informed consent for participating in the extensive PK sub-study.|||nanomoles (nmol) / litre (L)||Geometric Coefficient of Variation|Geometric Mean
2561993|NCT02642614|Primary|Safety and Tolerability of BI 1026706, as Assessed by Frequency (in Percent) of Patients With Treatment Emergent Adverse Events (TEAEs) Over the Treatment Period.|Safety and tolerability of BI 1026706, as assessed by frequency (in percent) of patients with treatment-emergent adverse events (TEAEs) over the treatment period.|From first drug administration until 4 days after last drug administration, up to 32 days|Treated set (TS): The TS included all patients who were randomized and treated with at least 1 dose of trial medication. The treatment assignment was determined based on the first treatment the patient received.|||Percentage of Patients|||Number
2561994|NCT02642575|Secondary|The Volume-based Diameter (dV) of the Follicle by Five-Dimensional Ultrasound|"All women would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) once daily for 5 days starting from 2nd day of the cycle then they will be scanned at 10th day by the same physician using Five Dimensional Ultrasound was done.~Five Dimensional Ultrasound automatically identifies hypoechogenic follicles within the captured ovarian volume and generates a set of measurements for each follicle including the volume-based diameter (dV) of the follicle.~The volume calculation is based on the voxel count within the identified follicle. It therefore represents a true measure of follicular volume."|10th day of the menstrual cycle|67 women were recruited from the Fetal Care Unit who fulfilled the inclusion criteria. Verbal consent was obtained from participants who were included into the study.|||mm^3||Standard Deviation|Mean
2561995|NCT02642575|Secondary|The Mean Follicular Diameter by Five-Dimensional Ultrasound|"All women would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) once daily for 5 days starting from 2nd day of the cycle then they will be scanned at 10th day by the same physician using Five Dimensional Ultrasound was done.~Five Dimensional Ultrasound automatically identifies hypoechogenic follicles within the captured ovarian volume and generates a set of measurements for each follicle. These measurements include the largest diameters in three orthogonal planes, the mean follicular diameter (MFD)"|10th day of the menstrual cycle|67 women were recruited from the Fetal Care Unit who fulfilled the inclusion criteria. Verbal consent was obtained from participants who were included into the study.|||mm||Standard Deviation|Mean
2561996|NCT02642575|Primary|The Mean Follicular Diameter by Two-Dimensional Ultrasound|"All women would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) once daily for 5 days starting from 2nd day of the cycle then they will be scanned at 10th day by the same physician using Two Dimensional Ultrasound was done.~Each follicle was assessed by measuring the maximal diameters on three orthogonal planes.~The mean of three diameters was calculated."|10th day of the menstrual cycle|67 women were recruited from the Fetal Care Unit who fulfilled the inclusion criteria. Verbal consent was obtained from participants who were included into the study.|||mm||Standard Deviation|Mean
2561997|NCT02642536|Secondary|Assessing PTSD Symptom Severity|PTSD symptom severity will be measured by the PCL-M at baseline and post treatment (16 weeks) minimum-maximum total score range (17-85) Higher value represents greater PTSD symptom severity An overall score was obtained from 4 subscales.|baseline||||units on a scale||Standard Deviation|Mean
2561998|NCT02642536|Secondary|Assessing Anxiety Symptom Severity|Anxiety symptom severity will be measured by the GAD-7 at baseline and post treatment (16 weeks) minimum-maximum total score range (0-21) Higher value represents greater anxiety symptom severity An overall score was obtained from the 7-item measure.|baseline||||units on a scale||Standard Deviation|Mean
2561999|NCT02642536|Secondary|Assessing Depression Symptom Severity|Changes in depression symptom severity will be measured at baseline and post treatment (16 weeks) minimum-maximum total score range (0-24) Higher value represents greater depressive symptom severity An overall score was obtained from the 8-item measure.|baseline||||units on a scale||Standard Deviation|Mean
2562000|NCT02642536|Secondary|Assessing PTSD Symptom Severity|PTSD symptom severity will be measured by the PCL-M at baseline and post treatment (16 weeks) minimum-maximum total score range (17-85) Higher value represents greater PTSD symptom severity An overall score was obtained from 4 subscales.|16 weeks||||units on a scale||Standard Deviation|Mean
2562001|NCT02642536|Secondary|Assessing Anxiety Symptom Severity|Anxiety symptom severity will be measured by the GAD-7 at baseline and post treatment (16 weeks) minimum-maximum total score range (0-21) Higher value represents greater anxiety symptom severity An overall score was obtained from the 7-item measure.|16 weeks||||units on a scale||Standard Deviation|Mean
2562002|NCT02642536|Secondary|Assessing Depression Symptom Severity|Changes in depression symptom severity will be measured at baseline and post treatment (16 weeks) minimum-maximum total score range (0-24) Higher value represents greater depressive symptom severity An overall score was obtained from the 8-item measure.|16 weeks|frequency analysis|||units on a scale||Standard Deviation|Mean
2562003|NCT02642536|Primary|Self Efficacy for Practicing Good Dietary Habits|Self-efficacy for practicing healthy dietary habits during difficult times will be assessed at baseline and post treatment (16 weeks) minimum-maximum total score range (20-100) Higher value represents greater sense of self-efficacy for healthy eating during difficult times The score was obtained from 3 subscales|16 weeks||||units on a scale||Standard Deviation|Mean
2562004|NCT02642536|Primary|Self Efficacy for Practicing Good Dietary Habits|Self-efficacy for practicing healthy dietary habits during difficult times will be assessed at baseline and post treatment (16 weeks) minimum-maximum total score range (20-100) Higher value represents greater sense of self-efficacy for healthy eating during difficult times The score was obtained from 3 subscales|baseline||||units on a scale||Standard Deviation|Mean
2562005|NCT02642536|Primary|Number of Days Engaged in Vigorous Activity|Initial assessment of vigor and time spent on physical activity minimum-maximum total score range (0-32) Higher value represents more days spent performing vigorous physical activity The score was obtained from a single item|baseline||||days spent performing vigorous activity||Standard Deviation|Mean
2562006|NCT02642536|Primary|Number of Days Engaged in Vigorous Activity|changes in vigor and time spent on physical activity practice will be measured by the MOVE! 11 assessment at post treatment (16 weeks) minimum-maximum total score range (0-48) Higher value represents more days spent performing vigorous activity|16 weeks||||days spent performing vigorous activity||Standard Deviation|Mean
2562007|NCT02642536|Primary|MOVE! Attendance|Number of MOVE! sessions attended minimum-maximum total score range (2-12) Higher value represents more sessions attended The score was obtained from a single item|16 weeks||||number of sessions||Standard Deviation|Mean
2562008|NCT02642432|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
2562009|NCT02642432|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Treatment Weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
2562010|NCT02642432|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2562011|NCT02642237|Primary|Peak Levels of Interferon Gamma-induced Protein 10 (IP-10) in Nasal Wash Fluid|Interferon gamma-induced protein 10 is a marker of viral-induced inflammation. Higher levels indicate a more pronounced inflammatory response upon a viral infection.|35 days after FLuenz inoculation||||pg/mL||95% Confidence Interval|Geometric Mean
2562012|NCT02642159|Secondary|Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Week 12 and 24 : Overall ITT Analysis|Glucose lowering treatment was calculated for non-insulin treatments as one for each unique treatment received and for insulin treatment as one in total for all participants who have taken one or more treatments. Absolute change = number of glucose-lowering treatments at specified week minus baseline value.|Baseline, Week 12 and 24|ITT population. Here, ‘Number Analyzed’ = participants with available data at the specified time points for each arm, respectively.|||Glucose lowering treatments||Standard Deviation|Mean
2562013|NCT02642159|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 and 24 : Overall ITT Analysis|Absolute change = FPG value at specified week minus FPG value at baseline.|Baseline, Week 12 and 24|ITT population. Here, ‘Number Analyzed’ = participants with available data at the specified time points for each arm, respectively.|||mmol/L||Standard Deviation|Mean
2562014|NCT02642159|Secondary|Absolute Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 and 24 : Overall ITT Analysis|Absolute change = HbA1c value at specified week minus HbA1c value at baseline.|Baseline, Week 12 and 24|ITT population. Here, ‘Number Analyzed’ = participants with available data at the specified time points for each arm, respectively.|||mmol/mol||Standard Deviation|Mean
2562015|NCT02642159|Secondary|Percent Change From Baseline in LDL-C Particle Number at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum|LDL-C particle number was calculated from lipid subfractions by NMR spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|LDL-C particle number ITT population. Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Least Squares Mean
2562016|NCT02642159|Secondary|Percent Change From Baseline in LDL-C Particle Number at Week 24: Overall ITT Analysis|LDL-C particle number was calculated from lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline LDL-C particle number on- or off-treatment (LDL-C particle number ITT population).|||Percent change||Standard Error|Least Squares Mean
2562017|NCT02642159|Secondary|Percent Change From Baseline in HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|HDL-C ITT population. Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Least Squares Mean
2562018|NCT02642159|Secondary|Percent Change From Baseline in HDL-C at Week 24 : Overall ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).|||Percent change||Standard Error|Least Squares Mean
2562019|NCT02642159|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|ITT population. Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Mean
2562020|NCT02642159|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24: Overall ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||Percent change||Standard Error|Mean
2562021|NCT02642159|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|ITT population. Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Mean
2562022|NCT02642159|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 : Overall ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment were included in the imputation model.|From Baseline to Week 24|ITT population.|||Percent change||Standard Error|Mean
2562023|NCT02642159|Secondary|Percent Change From Baseline in Total-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|Total-C ITT population. Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Least Squares Mean
2562024|NCT02642159|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 : Overall ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).|||Percent change||Standard Error|Least Squares Mean
2562025|NCT02642159|Secondary|Percent Change From Baseline in Apo B at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|Apo-B ITT population.Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Least Squares Mean
2562026|NCT02642159|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24: Overall ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo-B value on-or off-treatment (Apo-B ITT population).|||Percent change||Standard Error|Least Squares Mean
2562027|NCT02642159|Secondary|Percent Change From Baseline in Measured LDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum|Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|LDL-C ITT population. Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Least Squares Mean
2562028|NCT02642159|Secondary|Percent Change From Baseline in Measured LDL-C at Week 12: Overall ITT Analysis|Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|LDL-C ITT population.|||Percent change||Standard Error|Least Squares Mean
2562029|NCT02642159|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12: ITT- Intent to Prescribe Fenofibrate Stratum|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|ITT population. Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Least Squares Mean
2562030|NCT02642159|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12: Overall ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||Percent change||Standard Error|Least Squares Mean
2562031|NCT02642159|Secondary|Percent Change From Baseline in Measured LDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum|Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|LDL-C ITT population. Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Least Squares Mean
2562032|NCT02642159|Secondary|Percent Change From Baseline in Measured Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24: Overall ITT Analysis|Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline LDL-C value on-or off-treatment (LDL-C ITT population).|||Percent change||Standard Error|Least Squares Mean
2562033|NCT02642159|Primary|Percent Change From Baseline in Non-HDL-C at Week 24: ITT- Intent to Prescribe Fenofibrate Stratum|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment in the intent to prescribe fenofibrate stratum. The usual care here corresponds to fenofibrate.|From Baseline to Week 24|ITT population. Here, ‘Number of participants analyzed’ = participants from intent to prescribe fenofibrate stratum who were evaluable for this outcome measure.|||Percent change||Standard Error|Least Squares Mean
2562034|NCT02642159|Primary|Percent Change From Baseline in Non-HDL-C at Week 24: Overall Intent-to-treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.|||Percent change||Standard Error|Least Squares Mean
2562035|NCT02641912|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events on administration of investigational product from screening (Day 1) to 5 days after last administration of the product on Day 8. Number of participants with TEAEs were reported.|up to 13 days|Analysis for this outcome was conducted on safety population which included all participants who were randomized and received at least one dose of study treatment during the study.|||Number of participants|||Number
2562036|NCT02641912|Secondary|Mean Response to Post-Product Use Sensory Questionnaire (PPUSQ) on Day 1, Day 3, Day 8|Participants answered 4 questions on PPUSQ as follows: Q1:Which of the following statements best describes how much you liked the product overall?(rated on scale of 1-6, 1=Did not like it at all; 2=Did not like it that much; 3=Like it slightly; 4=Like it somewhat; 5=Like it very much; 6=Like it extremely), Q2:How pleasant would you say the flavor of the product was?(rated on scale of 1-5, 1=Not pleasant at all; 2=Slightly pleasant; 3=Moderately pleasant; 4=Very pleasant; 5=Extremely pleasant), Q3:How gentle would you say the product was?(rated on a scale of 1-7, 1=Not gentle at all; 2=Barely gentle; 3=Slightly gentle; 4=Moderately gentle; 5=Very gentle; 6=Extremely gentle; 7=The most gentle product imaginable), Q4:How fresh would you say your mouth felt after using the product?(rated on a scale of 1-5; 1=Not at all fresh; 2=Not very fresh; 3=Somewhat fresh; 4=Very fresh; 5=Extremely fresh) & response to these questions was reported. Scale score was averaged to calculate the response|Day 1, Day 3, Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||score on a scale||Standard Error|Least Squares Mean
2562037|NCT02641912|Secondary|Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1- QM9 on Day 8|Number Participants were reported who answered following questions with respect to how much they agree or disagree with following statements over the last week & how much they agreed that symptoms were manageable (M). Q40:It's a big issue for me; Q41:My dry mouth makes me feel different to other people; Q42:My mouth is deteriorating, Dry mouth can also affect your quality of life. Q43:Dry mouth is part of my life nowadays; Q44:Dry mouth is a quality of life issue; Q45:My dry mouth stops me enjoying things; Q46:How would you rate your oral health overall?, and Think back over last week about things you have done to relieve your symptoms. How much do you agree or disagree that those things have made following symptoms more manageable? M1:Uncomfortable; M2:Bad taste; M3:Loss of Taste; M4:Lips sticking to roof of mouth; M5:Tongue sticking to roof of mouth; M6: Throat dry; M7:No moisture; M8:Devoid of any wetness M9:Mouth feels tight ?|Prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||Number of participants|||Number
2562038|NCT02641912|Secondary|Number of Participants With Response to DMI QoL Question(Q) Numbers 28 to 39 on Day 8|Number of participants were reported who answered following questions, these questions are about how you have coped with your dry mouth over last week. Please tell us whether you agree or disagree with each of the statements. Q28:I have to drink a lot of water; Q29:I need to carry water with me everywhere I go; Q30:I worry about where I can go to toilet; Q31:I have to drink something with food; Q32:I have to clean my teeth more than most people; Q33:I choose moist foods when I can; Q34:I need sauces to help me eat; Q35:I avoid certain foods or drinks, There are other things that help some people with dry mouth. Please tell us how often over last week, that you have done these things. Q36:I have chewed gum; Q37:I have chewed my food for longer; Q38:I have sucked sweets or mints or pastilles; Q39:I have breathed through my nose rather than my mouth.|Prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||Number of participants|||Number
2562039|NCT02641912|Secondary|Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 8|Number of participants were reported who answered following questions, how often during last week has a dry mouth affected these aspects of your life? Q16:My dry mouth interrupts my sleep; Q17:My dry mouth makes it difficult for me to speak; Q18:My dry mouth interferes with me being intimate with those close to me; Q19:My dry mouth means it takes me longer to eat meals, Having a dry mouth can affect people's moods and emotions. Please tell us how much you agree or disagree that your dry mouth has given you these moods over the last week Q20:Irritable; Q21:Worried; Q22:Frustrated; Q23:Always on my mind; Q24:It gets me down, and How much do you agree or disagree that your dry mouth has affected your time with other people over last week? Q25:Drinking or going to the toilet interrupts my conversations; Q26:I have difficulty using the telephone Q27:I feel different because of the things I have to do to look after my mouth.|Prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||Number of participants|||Number
2562057|NCT02641912|Secondary|Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 1|Participants answered to the 3 question in PPAQ1. Q1= Having a immediate dry mouth relief; Q2= Having a immediate lubricating effect; Q3= Having a immediate moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|5 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562040|NCT02641912|Secondary|Number of Participants With Responses to DMI QoL Question(Q) Numbers 1 to 15 on Day 8|Number of participants were reported who answered following questions, Q1:Thinking back during last week, how often has your dry mouth been a problem?; Having a dry mouth affects people in different ways. Please tell us how much you agree or disagree whether your dry mouth has affected you in these ways in last week Q2:Rawness or soreness? Q3:Uncomfortable? Q4:Bad taste? Q5:Loss of taste? Q6:Lips sticking to teeth? Q7:Tongue sticking to roof of mouth? Q8:Throat dry? Q9:No moisture? Q10:Mouth feels tight? Dry mouth stops some people doing things. How much do you agree or disagree that it has been difficult for you to do following things in last week? Q11:Eating dry foods? Q12:Eating sticky foods? Q13:Eating hard or scratchy foods such as crisps, biscuits or nuts?, and How much do you recognize yourself in following statements, based on last week? Q14:Swallowing has been difficult for me this last week? Q15:Drinking so much means that I go to the toilet more than other people?|Prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||Number of participants|||Number
2562041|NCT02641912|Secondary|Number of Participants With Response to DMI QoL Question (Q) Number 40 to 46 and QM1-QM8 on Day 1|Number Participants were reported who answered following questions with respect to how much they agree or disagree with following statements over the last week & how much they agreed that symptoms were manageable (M). Q40:It's a big issue for me; Q41:My dry mouth makes me feel different to other people; Q42:My mouth is deteriorating, Dry mouth can also affect your quality of life; Q43:Dry mouth is part of my life nowadays; Q44:Dry mouth is a quality of life issue; Q45:My dry mouth stops me enjoying things; Q46:How would you rate your oral health overall?, and Think back over last week about things you have done to relieve your symptoms. How much do you agree or disagree that those things have made following symptoms more manageable? M1: Uncomfortable; M2: Bad taste; M3:Loss of Taste; M4: Lips sticking to roof of mouth; M5: Tongue sticking to roof of mouth; M6: Throat dry; M7: No moisture M8:Devoid of any wetness M9:Mouth feels tight ?|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||Number of participants|||Number
2562042|NCT02641912|Secondary|Number of Participants With Response to DMI QoL Question (Q) Number 28 to 39 on Day 1|Number of participants were reported who answered following questions, these questions were about how participants had coped with their dry mouth over the last week with respect to agree or disagree with each of the following questions. Q28:I have to drink a lot of water; Q29:I need to carry water with me everywhere I go; Q30:I worry about where I can go to the toilet; Q31:I have to drink something with food; Q32:I have to clean my teeth more than most people; Q33:I choose moist foods when I can; Q34:I need sauces to help me eat; Q35:I avoid certain foods or drinks, and There are other things that help some people with dry mouth. Please tell us how often over the last week, that you have done these things. Q36:I have chewed gum; Q37:I have chewed my food for longer; Q38:I have sucked sweets or mints or pastilles; Q39:I have breathed through my nose rather than my mouth.|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||Number of participants|||Number
2562043|NCT02641912|Secondary|Number of Participants With Responses to DMI QoL Question(Q) Numbers 16 to 27 on Day 1|Number of Participants were reported who answered following questions, how often during last week has a dry mouth affected these aspects of your life? Q16:My dry mouth interrupts my sleep; Q17:My dry mouth makes it difficult for me to speak; Q18:My dry mouth interferes with me being intimate with those close to me; Q19:My dry mouth means it takes me longer to eat meals, Having a dry mouth can affect people's moods & emotions. Please tell us how much you agree or disagree that your dry mouth has given you these moods over last week; Q20:Irritable; Q21:Worried; Q22:Frustrated; Q23:Always on my mind; Q24:It gets me down, How much do you agree or disagree that your dry mouth has affected your time with other people over the last week?; Q25:Drinking or going to the toilet interrupts my conversations; Q26:I have difficulty using the telephone; Q27:I feel different because of the things I have to do to look after my mouth.|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||Number of participants|||Number
2562044|NCT02641912|Secondary|Number of Participants With Response to Dry Mouth Inventory Quality of Life (DMI QoL) Question (Q) Numbers 1 to 15 on Day 1|Number of Participants were reported who answered following questions, Q1:Thinking back during last week, how often has your dry mouth been a problem? Having a dry mouth affects people in different ways. Please tell us how much you agree or disagree whether your dry mouth has affected you in these ways in last week Q2:Rawness or soreness? Q3:Uncomfortable? Q4:Bad taste? Q5:Loss of taste? Q6:Lips sticking to teeth? Q7:Tongue sticking to roof of mouth? Q8:Throat dry? Q9:No moisture? Q10:Mouth feels tight? Dry mouth stops some people doing things. How much do you agree or disagree that it has been difficult for you to do following things in last week? Q11:Eating dry foods? Q12:Eating sticky foods? Q13:Eating hard or scratchy foods such as crisps, biscuits or nuts?, How much do you recognize yourself in following statements, based on the last week? Q14:Swallowing has been difficult for me this last week? Q15:Drinking so much means that I go to the toilet more than other people?|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||Number of participants|||Number
2562064|NCT02641912|Secondary|Mean Response to the Question 1 'Relieving the Discomfort of Dry Mouth' in PPAQ3 at 60 and 240 Mins Post Treatment on Day 8|Participants answered to the question 1 'Relieving the discomfort of dry mouth' in PPAQ3 and rated this question on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|60 and 240 mins post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562045|NCT02641912|Secondary|Mean Response to SAoP QoL 2 Prior to Treatment on Day 8|Participants answered to the 6 questions in SAoP QoL 2 as follows: Q1= Looking back over the last 7 days, has your dry mouth caused discomfort?; Q2= Looking back over the last 7 days, has your dry mouth made it uncomfortable to speak?; Q3= Looking back over the last 7 days, has your dry mouth interrupted your sleep?; Q4= Looking back over the last 7 days, has your dry mouth affected your social interactions?; Q5= Looking back over the last 7 days, has your dry mouth caused you to avoid certain foods?; Q6= Looking back over the last 7 days, has your dry mouth interfered with your daily activities? These questions were rated on scale as follows: 0 = not at all; 1 = a little; 2 = somewhat; 3 = quite a bit; 4 = very much. Scale score was averaged to calculate the response.|prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||score on a scale||Standard Deviation|Mean
2562046|NCT02641912|Secondary|Mean Response to Subjective Assessment of Patient's Quality of Life (SAoP QoL1) Prior to Treatment on Day 1|Participants answered to the 6 questions in SAoP QoL as follows: Q1= Does your dry mouth cause discomfort?; Q2= Does your dry mouth make it uncomfortable to speak?; Q3= Does your dry mouth interrupt your sleep?; Q4= Does your dry mouth affect your social interactions?; Q5= Does your dry mouth cause you to avoid certain foods?; Q6= Does your dry mouth interfere with your daily activities? These questions were rated on a scale as follows: 0 = not at all; 1 = a little; 2 = somewhat; 3 = quite a bit; 4 = very much. Scale score was averaged to calculate the response.|Prior to treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy.|||score on a scale||Standard Deviation|Mean
2562047|NCT02641912|Secondary|Mean Response to PPAQ4 Prior to Treatment on Day 3|Participants answered to the 9 questions in PPAQ4. Q1= Providing relief all night; Q2= Reducing the number of times you wake up from dry mouth; Q3= Feeling less parched when you wake up; Q4= Having a long lasting dry mouth relief; Q5= Having a long lasting lubricating effect; Q6= Having a long lasting moisturizing effect; Q7= Having an overall dry mouth relief; Q8= Having an overall lubrication effect; Q9= Having an overall moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|Prior to treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562048|NCT02641912|Secondary|Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 3|Participants answered to the 14 questions in PPAQ3. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|240 mins post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562049|NCT02641912|Secondary|Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 3|Participants answered to the 14 questions in PPAQ3 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|120 mins post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562050|NCT02641912|Secondary|Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 3|Participants answered the 14 questions of PPAQ3 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|60 mins. post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562089|NCT02641587|Primary|Concentration of S-phenylmercapturic Acid (S-PMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors."|5 days|Per Protocol (PP) population|||pg/mg creat||95% Confidence Interval|Geometric Least Squares Mean
2562051|NCT02641912|Secondary|Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 3|Participants answered to the 11 questions in PPAQ2 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|30 mins post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562052|NCT02641912|Secondary|Mean Response to PPAQ1 at 5 Mins Post Treatment on Day 3|Participants answered to the 3 questions in PPAQ1 as follows: Q1= Having a immediate dry mouth relief; Q2= Having a immediate lubricating effect; Q3= Having a immediate moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|5 mins post treatment on Day 3|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562053|NCT02641912|Secondary|Mean Response to PPAQ3 at 240 Mins Post Treatment on Day 1|Participants answered to the 14 questions in PPAQ3 as follows: Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|240 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562054|NCT02641912|Secondary|Mean Response to PPAQ3 at 120 Mins Post Treatment on Day 1|Participants answered to the 14 questions in PPAQ3. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|120 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562055|NCT02641912|Secondary|Mean Response to PPAQ3 at 60 Mins Post Treatment on Day 1|Participants answered to the 14 questions in PPAQ3. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|60 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562056|NCT02641912|Secondary|Mean Response to PPAQ2 at 30 Mins Post Treatment on Day 1|Participants answered to the 11 question in PPAQ2. Q1= Relieving the discomfort of dry mouth; Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|30 mins post treatment on Day 1|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562090|NCT02641587|Primary|Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors."|5 days|Per Protocol (PP) population|||ng/mg creat||95% Confidence Interval|Geometric Least Squares Mean
2562058|NCT02641912|Secondary|Mean Response to Product Performance And Attributes Questionnaire 4(PPAQ4) Prior to Treatment on Day 8|Participants answered the 9 questions of PPAQ4. Q1= Providing relief all night; Q2= Reducing the number of times you wake up from dry mouth; Q3= Feeling less parched when you wake up; Q4= Having a long lasting dry mouth relief; Q5= Having a long lasting lubricating effect; Q6= Having a long lasting moisturizing effect; Q7= Having an overall dry mouth relief; Q8= Having an overall lubrication effect; Q9= Having an overall moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|prior to treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562059|NCT02641912|Secondary|Mean Response to Questions (Q) Number 2 to 14 (Q2 to Q14) From PPAQ3 at 240 Mins. Post Treatment on Day 8|Participants answered Q2- Q14 from PPAQ3. Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|240 mins. post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562060|NCT02641912|Secondary|Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 120 Mins. Post Treatment on Day 8|Participants answered Q2- Q14 from PPAQ3. Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|120 mins. post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562061|NCT02641912|Secondary|Mean Response to Question (Q) Number 2 to 14 (Q2-Q14) From PPAQ3 at 60 Mins. Post Treatment on Day 8|Participants answered Q2- Q14 from PPAQ3. Q2= Feeling comfortable in the mouth; Q3= Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q9= Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal; Q12= Having a long lasting dry mouth relief; Q13= Having a long lasting lubricating effect; Q14= Having a long lasting moisturizing effect. These question were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|60 mins. post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562062|NCT02641912|Secondary|Mean Response to Question(Q) Number 2 to 11 (Q2 to Q11) From PPAQ2 at 30 Mins Post Treatment on Day 8|Participants answered questions, Q2-Q11 in PPAQ2. Q2=Feeling comfortable in the mouth; Q3=Soothing your mouth; Q4= Allowing you to speak without difficulty; Q5= Effectively moistens your mouth; Q6= Effectively lubricates your mouth; Q7= Helping to freshen your breath; Q8= Protecting your mouth from drying out; Q=9 Providing whole mouth comfort; Q10= Helping you to swallow without difficulty; Q11= Helping mouth feel normal. These questions were rated on a scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|30 mins post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562063|NCT02641912|Secondary|Mean Response to Product Performance And Attributes Questionnaire1(PPAQ1) at 5 Mins Post Treatment on Day 8|Participants answered 3 questions in PPAQ1. Q1= Having a immediate dry mouth relief; Q2= Having a immediate lubricating effect; Q3= Having a immediate moisturizing effect. These questions were rated on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|5 mins post treatment on Day 8|Analysis for this outcome was conducted on ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. n= number of participants analyzed for this outcome for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562091|NCT02641587|Primary|Concentrations of Monohydroxybutenylmercapturic Acid (MHBMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors."|5 days|Per Protocol (PP) population|||pg/mg creat||95% Confidence Interval|Geometric Least Squares Mean
2562092|NCT02641561|Secondary|The Number of Participants Who Were Readmitted After ERCP as Assessed by Medical Record and Patients Self-reporting||30 days after ERCP||||Participants|||Count of Participants
2562065|NCT02641912|Secondary|Mean Response to the Question 1 'Relieving the Discomfort of Dry Mouth' in Product Performance And Attributes Questionnaire 2 (PPAQ2) at 30 Mins Post Treatment on Day 8|Participants answered to the question 1 'Relieving the discomfort of dry mouth' in PPAQ2 and rated this question on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|30 mins post treatment on Day 8|ITT population which included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed for this outcome is the part of ITT population for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562066|NCT02641912|Primary|Mean Response to the Question 1 'Relieving the Discomfort of Dry Mouth' in Product Performance and Attributes Questionnaire 3 (PPAQ3) at 120 Minutes(Mins) Post Treatment on Day 8|Participants answered question 1 'Relieving the discomfort of dry mouth' in PPAQ3 and rated this question on scale as follows: N/A = Not Applicable; 1 = poor; 2 = fair; 3 = good; 4 = very good; 5 = excellent. Scale score was averaged to calculate the response.|120 mins post treatment on Day 8|Intent-to-treat (ITT) population which included all participants who were randomized, received study treatment at least once & provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed for this outcome is the part of ITT population for specific question at specific time point.|||score on a scale||Standard Deviation|Mean
2562067|NCT02641730|Secondary|Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score|EQ-5D is designed for self-completion by participants and consists of EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and unable. The EQ VAS records the respondent's self-rated health on a vertical, VAS where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0). Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion their baseline value carried forward to the post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Baseline, Week 16, 32, 52, 72 and Week 84|Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.|||Units on a scale||Standard Deviation|Mean
2562068|NCT02641730|Secondary|Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score|SF-36 consists of 8 individual domains, which are weighted sums of questions in their section. 8 domains are: vitality(VT), physical functioning(PF), bodily pain(BP), general health(GH), Role-Physical(RP), Role-Emotional(RE), social functioning(SF) and mental health(MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on scale scores, summary PCS is derived. Scales contributing most to the scoring of the SF-36 PCS include PF,RP,BP and GH. Other domains not noted contribute to scoring but to a lesser degree. Scoring is derived based on an algorithm as presented in Japanese edition manual. Summary PCS score is also scaled from 0 to 100 with higher scores indicating better health. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Baseline, Week 16, 32, 52, 72 and Week 84|Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.|||Units on a scale||Standard Deviation|Mean
2562069|NCT02641730|Secondary|Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score|SF-36 consists of 8 individual domains, which are weighted sums of questions in their section. 8 domains are: vitality(VT), physical functioning(PF), bodily pain(BP), general health(GH), Role-Physical(RP), Role-Emotional(RE), social functioning(SF) and mental health(MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on scale scores, summary PCS is derived. Scales contributing most to the scoring of the SF-36 PCS include PF,RP,BP and GH. Other domains not noted contribute to scoring but to a lesser degree. Scoring is derived based on an algorithm as presented in Japanese edition manual. Summary PCS score is also scaled from 0 to 100 with higher scores indicating better health. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Baseline, Week 16, 32, 52, 72 and Week 84|Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.|||Units on a scale||Standard Deviation|Mean
2562070|NCT02641730|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI) Score|The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess the impact of the disease on a participant's QOL. It is a 10-item participant-reported outcome questionnaire that, in addition to evaluating overall QOL, can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score that can range from 0 to 30. Higher score indicates more severe disease. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Baseline, Week 16, 32, 52, 72 and Week 84|Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.|||Units on a scale||Standard Deviation|Mean
2562093|NCT02641561|Secondary|The Length of Stay (LOS) of Participants After ERCP if Medical Care is Sought as Assessed in Days||30 days after ERCP||||days||Standard Deviation|Mean
2562071|NCT02641730|Secondary|Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement|The PGA documents the Physician's Global Assessment of the participant's palmoplantar overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants who achieved a PGA score of clear (0) or almost clear (1) and had at least a 2-grade improvement from baseline were reported. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders through Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84|Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.|||Percentage of participants|||Number
2562072|NCT02641730|Secondary|Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1)|The PGA documents the Physician's Global Assessment of the participant's palmoplantar overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants who achieved a PGA score of clear (0) or almost clear (1) were reported. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders through Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84|Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.|||Percentage of participants|||Number
2562073|NCT02641730|Secondary|Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score|The PGA documents the Physician's Global Assessment of the PPP overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84|Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.|||Percentage of participants|||Number
2562074|NCT02641730|Secondary|Percentage of Participants Who Achieved a PPSI-100 Response|PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 72 and Week 84|Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.|||Percentage of participants|||Number
2562075|NCT02641730|Secondary|Percentage of Participants Who Achieved a PPSI-90 Response|PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. PPSI 90 response represents participants who achieved at least a 90% improvement from baseline in the PPSI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84|Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.|||Percentage of participants|||Number
2562076|NCT02641730|Secondary|Percentage of Participants Who Achieved a PPSI-75 Response|PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84|Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.|||Percentage of participants|||Number
2562094|NCT02641561|Secondary|The Number of Participants With Post-procedural Medical Care (ED Visit, Urgent Care, Hospitalization) as Assessed by Medical Record and Patients Self-reporting||30 days after ERCP||||Participants|||Count of Participants
2562095|NCT02641561|Secondary|The Number of Participants With Mortality After ERCP as Assessed by Medical Record Reporting||30 days after ERCP||||Participants|||Count of Participants
2562077|NCT02641730|Secondary|Percentage of Participants Who Achieved a PPSI-50 Response|PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84|Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.|||Percentage of participants|||Number
2562078|NCT02641730|Secondary|Percentage of Participants Who Achieved a PPPASI-100 Response|PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-100 response represents participants who achieved at least a 100% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84|Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.|||Percentage of participants|||Number
2562079|NCT02641730|Secondary|Percentage of Participants Who Achieved a PPPASI-90 Response|PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-90 response represents participants who achieved at least a 90% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84|Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.|||Percentage of participants|||Number
2562080|NCT02641730|Secondary|Percentage of Participants Who Achieved a PPPASI-75 Response|PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-75 response represents participants who achieved at least a 75% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84|Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.|||Percentage of participants|||Number
2562081|NCT02641730|Secondary|Percentage of Participants Who Achieved a PPPASI-50 Response|PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84|Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.|||Percentage of participants|||Number
2562096|NCT02641561|Secondary|The Number of Participants Who Undergo Surgery After ERCP, as Assessed by Surgical Operative Report||30 days after ERCP||||Participants|||Count of Participants
2562097|NCT02641561|Secondary|The Number of Participants With Perforation After ERCP as Assessed by Abdominal Imaging Suggestive of Perforation|Imaging may include Computer Tomography|30 days after ERCP||||Participants|||Count of Participants
2562098|NCT02641561|Secondary|The Number of Participants With Pancreatic Abscess After ERCP as Assessed by Abdominal Imaging Suggestive of Pancreatic Abscess|Imaging may include Computer Tomography|30 days after ERCP||||Participants|||Count of Participants
2562099|NCT02641561|Secondary|The Number of Participants With Pancreatic Pseudocyst After ERCP as Assessed by Abdominal Imaging Suggestive of Pseudocyst|Imaging may include Computer Tomography|30 days after ERCP||||Participants|||Count of Participants
2562082|NCT02641730|Secondary|Change From Baseline in PPSI Total Score|PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84|Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.|||Units on a scale||Standard Deviation|Mean
2562083|NCT02641730|Secondary|Change From Baseline in PPPASI Total Score|PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, which account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84|Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period). Here 'n' signifies the number of participants analyzed at the specified time point.|||Units on a scale||Standard Deviation|Mean
2562084|NCT02641730|Secondary|Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16|PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants who discontinue study agent as they met a TF criterion were considered as non-responders at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Week 16|Population included Randomized analysis set. The missing values were imputed based on TF criterion and LOCF method until Week 60; no imputation performed for missing data after Week 60 (in observational period).|||Percentage of participants|||Number
2562085|NCT02641730|Secondary|Change From Baseline in Palmoplantar Severity Index (PPSI) Total Score at Week 16|PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. A higher score indicates more severe disease. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Baseline and Week 16|Population included Randomized analysis set. The missing values were imputed based on Treatment Failure (TF) criterion and last scheduled observation carried forward (LOCF) method until Week 60; no imputation performed for missing data after Week 60 (in observational period).|||Units on a scale||Standard Deviation|Mean
2562086|NCT02641730|Primary|Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16|PPPASI assesses severity of palmoplantar pustulosis (PPP) lesions and response to therapy. In PPPASI, palms, soles are divided into 4 regions: right palm(RP), left palm(LP), right sole(RS), left sole(LS), that account for 20 percent (%), 20%,30%,30%, respectively, of total surface area(TSA) of palms, soles. Each area is assessed separately for erythema(E), pustules/vesicles (P), desquamation/scales (D), each rated on a scale (0-4). PPPASI produces score range of 0-72 using formula, PPPASI=(E+P+D)Area*0.2(RP)+(E+P+D)Area*0.2 (LP)+(E+P+D)Area*0.3(RS)+(E+P+D)Area*0.3(LS). Higher a score more the severe disease. Participants who discontinue study agent as they met treatment failure(TF) criterion(lack of efficacy/AE of worsening of PPP/who started a protocol-prohibited medication/therapy that could improve PPP), their baseline value carried forward to post baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.|Baseline and Week 16|Randomized analysis set: all randomized participants at Week 0, whether they received study treatment or not and had any post-baseline efficacy assessment. Missing values were imputed based on TF criterion, last observation carried forward (LOCF) method till Week 60;no imputation performed for missing data after Week 60 (in observational period).|||Units on a scale||Standard Deviation|Mean
2562087|NCT02641587|Primary|Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)|"Concentrations measured at Day 90 in urine, adjusted for creatinine.~Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 90 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors."|90 days|Per Protocol (PP) population|||pg/mg creat||95% Confidence Interval|Geometric Least Squares Mean
2562088|NCT02641587|Primary|Levels of Carboxyhemoglobin (COHb)|"% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.~Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors."|5 days|Per Protocol (PP) population|||% of saturation of hemoglobin||95% Confidence Interval|Geometric Least Squares Mean
2562104|NCT02641561|Secondary|The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)|white blood cell (WBC) count < 4000 cells/mm³ (4 x 109 cells/L)|30 days after ERCP||||Participants|||Count of Participants
2562105|NCT02641561|Secondary|The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)|Temperature < 36°C(96.8°F) or > 38°C(100.4°F)|30 days after ERCP||||Participants|||Count of Participants
2562106|NCT02641561|Secondary|The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)|PaCO2 < 4.3 kilopascal (kPa) (32 mmHg)|30 days after ERCP||||Participants|||Count of Participants
2562107|NCT02641561|Secondary|The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)|Respiratory rate > 20 breaths per minute|30 days after ERCP||||Participants|||Count of Participants
2562108|NCT02641561|Secondary|The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)|Heart rate > 90 beats per minutes|30 days after ERCP||||Participants|||Count of Participants
2562109|NCT02641561|Secondary|The Number of Participants With Acute Respiratory Distress Syndrome (ARDS) After ERCP as Assessed by ARDSnet Criterion (Below)|bilateral opacities on chest imaging not explained by other lung pathology, respiratory failure not explained by heart failure or volume, and overload and a pulmonary arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio under 300, PaO2/FiO2 ratio is the partial pressure arterial oxygen and fraction of inspired oxygen|30 days after ERCP||||Participants|||Count of Participants
2562110|NCT02641561|Primary|The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Imaging Suggestive of Acute Pancreatitis|Imaging may include Computer Tomography|30 days after ERCP||||Participants|||Count of Participants
2562111|NCT02641561|Primary|The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Either Elevated Amylase or Lipase 3 x Upper Limit of Normal|amylase or lipase|30 days after ERCP||||Participants|||Count of Participants
2562112|NCT02641522|Other Pre-specified|Adverse Event Monitoring|Monitor adverse events associated with siltuximab treatment. All AE related to study drug will be tabulated along with their grade.|0-to-12 weeks|||||||
2562113|NCT02641522|Primary|Percent Change From Baseline in IL-6 Stimulated Intracellular p-STAT3 at Week 12|Change in IL-6 stimulated intracellular p-STAT3 between Week 12 and baseline|0-to-12 weeks|1 participant was excluded from analysis because of technical problems with processing samples.|||Percent change from Baseline||Standard Deviation|Mean
2562114|NCT02641392|Primary|Number of Participants With Treatment Emergent Adverse Events From Week 0 to Week 208|A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of GED-0301 and up to 28 days after the last GED- 0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale; Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain.|From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 16.1 weeks in the GED-0301 40 mg Alt dose; 16.3 weeks in the GED 40 mg continuous dose and 56.1 weeks in the GED-0301 160 mg Alt dose|Safety population includes participants who were received at least one dose of GED-0301. Participants were included in the group corresponding to the treatment regimen they actually received.|||Participants|||Count of Participants
2562115|NCT02641379|Secondary|Number of Participants With Adverse Events and Serious Adverse Events (Part 2)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 96|The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.|||Number of participants|||Number
2562116|NCT02641379|Secondary|Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2)|Liver fibrosis stage was based upon biopsy and scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline (Day 1) is presented.|Baseline (Day 1)|The ITT population included all participants randomized and allocated to receive treatments.|||Number of participants|||Number
2562117|NCT02641379|Secondary|Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2)|The FSS is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C).|Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed for a given time point.|||scores on a scale||Standard Deviation|Mean
2562237|NCT02639637|Secondary|Glucose|Glucose was measured by the glucose oxidase method using a YSI glucose analyzer|Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days were separated by five weeks, a four-week washout and one-week treatment period.||||mg/dL||Standard Deviation|Mean
2562118|NCT02641379|Secondary|Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)|The SF-36 is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores were presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C). Lower score indicate worsening.|Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.|||scores on a scale||Standard Deviation|Mean
2562119|NCT02641379|Secondary|Percentage of Participants Achieving Sustained Virological Response in Groups C and D by Genotype at the End of Follow-up (Part 2)|The SVR was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA < 15 IU/ml at Week 48 of Group D and at Week 96 of Group C). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 96 for Group C and Week 48 for Group D.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments.|||Percentage of participants||95% Confidence Interval|Number
2562120|NCT02641379|Secondary|Percentage of Participants With Virological Response Rates in Group A1, B1, C and D at the End of the Treatment Period (Part 2)|ETR virological response rate at the end of treatment period was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV RNA quantitative PCR result < 15 IU/ml at Week 24 for Group D, at Week 48 for Group A1, at Week 72 for Groups B1 and C). Participants without a HCV RNA PCR (missing values) at this time point were considered as non-responders in this calculation. The end of treatment period was defined as Week 48 for Group A1, Week 72 for Groups B1 and C1, and Week 24 for Group D.|Up to Week 72|The ITT population included all participants randomized and allocated to receive treatments.|||Percentage of participants||95% Confidence Interval|Number
2562121|NCT02641379|Secondary|Percentage of Participants With Relapse Rates in Groups A1 and B1 at the End of Follow-up (Part 2)|Virological relapse rate was defined as percentage of participants with non-detectable HCV RNA (< 15 IU/ml) at the EoT and detectable HCV RNA (≥ 15 IU/ml) at the end of FU. The end of treatment was defined as Week 48 in Group A1 and Week 72 in Group B1 and the end of follow-up was defined as Week 72 in Group A1 and Week 96 in Group B1.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments.|||Percentage of participants||95% Confidence Interval|Number
2562122|NCT02641379|Secondary|Number of Participants With Adverse Events and Serious Adverse Events (Part 1)|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 96|The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.|||Number of participants|||Number
2562123|NCT02641379|Secondary|Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1)|Liver fibrosis stage was scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline is presented.|Baseline (Day 1)|The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.|||Number of participants|||Number
2562124|NCT02641379|Secondary|Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1)|The Fatigue Severity Scale (FSS) is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A and B) and at Week 96 (for Group B).|Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.|||scores on a scale||Standard Deviation|Mean
2562125|NCT02641379|Secondary|Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)|The Short Form-36 (SF-36) is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual and Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores are presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A and B) and at Week 96 (for Group B). Lower score indicate worsening.|Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.|||scores on a scale||Standard Deviation|Mean
2562254|NCT02639559|Secondary|Number of Recipients With Primary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With BL-8040 (Arm 2 Recipients Only)||Up to 1 year after transplantation|-Donors are not evaluable for this outcome measure.|||Participants|||Count of Participants
2562126|NCT02641379|Secondary|Percentage of Participants Achieving Sustained Virological Response in Groups A, B, C, and D at the End of Follow-up (Part 1)|The SVR was defined as the percentage of participants in each group with a non-detectable HCV RNA result at 24 weeks post-completion of the treatment period (HCV RNA < 15 IU/ml at Week 48 of Group D, at Week 72 of Group A, and at Week 96 of Groups B and C). Participants without a HCV RNA PCR at this time point were considered as non-responders in this calculation. The end of follow-up was defined as Week 72 for Group A, Week 96 for Groups B and C, and Week 48 for Group D.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments.|||Percentage of participants||95% Confidence Interval|Number
2562127|NCT02641379|Secondary|Percentage of Participants With Virological Response Rate in Groups A, B, C, and D at the End of Treatment Period (Part 1)|End of treatment response (ETR) rate was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV negative at Week 24 of Group D, Week 48 of Group A and at Week 72 of Groups B and C). Participants without a HCV RNA results at this time point were considered as non-responders. End of the treatment period was defined as Week 48 for Group A, Week 72 for Groups B and C, and Week 24 for Group D.|Up to Week 72|The ITT population included all participants randomized and allocated to receive treatments.|||Percentage of participants||95% Confidence Interval|Number
2562128|NCT02641379|Primary|Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2)|The Sustained Virological Response (SVR) was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA < 15 IU/ml at Week 72 of Groups A1 and E, and at Week 96 of Group B1). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 72 for Groups A1 and E, and Week 96 for Group B1. The SVR for treatment Groups A1 + B1 and E, stratified for genotype (Genotype I and Genotype IV) is presented.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed according to genotype.|||Percentage of participants||95% Confidence Interval|Number
2562129|NCT02641379|Primary|Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1)|Relapse rate (RR) was defined as the percentage of participants with non-detectable HCV RNA (< 100 copies/ml) at the end of treatment and detectable HCV RNA at the end of follow-up. End of treatment was defined as Week 48 for Group A and Week 72 for Group B, respectively. The end of follow-up was defined as Week 72 for Group A and Week 96 for Group B, respectively. Relapse rate for treatment Groups A and B, stratified for genotype (Genotype I and Genotype IV) and Week 4 response (< 600 units/milliliter [U/ml] and >= 600 U/ml) is presented.|Up to Week 96|The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = number of participants analyzed according to genotype and Week 4 response.|||Percentage of participants||95% Confidence Interval|Number
2562130|NCT02641249|Secondary|Change in the Total Number of Bradycardia Episodes (<100 Beats Per Minute (Bpm), at Least 5 Seconds Long) During Intervention and Without the Intervention|The total number of bradycardia episodes to <100 bpm lasting >5 seconds/episode will be compared during periods of vibration (intervention) to periods of no vibrations (no intervention).|12 hours of intervention/12 hours of no intervention|Premature neonates (29 +/- 2.5 weeks gestational age at birth), with a diagnosis of apnea of prematurity|||bradycardias||Standard Error|Mean
2562131|NCT02641249|Secondary|Change in the Total Number of Intermittent Hypoxic Episodes to <90% Lasting >5 Seconds/Episode During the Intervention and Without Intervention|The total number of intermittent hypoxic episodes to <90% (pulse oximetry) lasting >5 seconds/episode will be compared during periods of vibration (intervention) to periods of no vibrations (no intervention).|12 hours of intervention/12 hours of no intervention|Premature neonates (29 +/- 2.5 weeks gestational age at birth), with a diagnosis of apnea of prematurity|||IH events||Standard Error|Mean
2562132|NCT02641249|Primary|Change in Total Number of Episodes of Apnea/Breathing Pauses During Intervention and Without Intervention|The total number of apneas/breathing pauses will be compared during periods of vibration (intervention) to periods of no vibrations (no intervention).|12 hours of intervention/12 hours of no intervention|Premature neonates (29 +/- 2.5 weeks gestational age at birth), with a diagnosis of apnea of prematurity|||breathing pauses||Standard Error|Mean
2562133|NCT02641067|Primary|Apparent Volume of Distribution of Plasma Doravirine During the Terminal Phase (Vz/F)|Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment|All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2562134|NCT02641067|Primary|Apparent Clearance of Plasma Doravirine After Extravascular Administration (CL/F)|Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment|All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||Liter/hour||Geometric Coefficient of Variation|Geometric Mean
2562135|NCT02641067|Primary|Apparent Terminal Half-life (t1/2) of Plasma Doravirine|Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment|All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2562136|NCT02641067|Primary|Time to Maximum Observed Plasma Concentration (Tmax) of Doravirine|Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment|All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||Hours||Full Range|Median
2562137|NCT02641067|Primary|Area Under the Plasma Concentration Versus Time Curve From 0 Hours to the Time of Last Quantifiable Sample of Doravirine (AUC 0-last)|Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment|All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||μM•hr||Geometric Coefficient of Variation|Geometric Mean
2562138|NCT02641067|Primary|Maximum Observed Plasma Concentration (Cmax) of Doravirine|Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment|All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||nM||90% Confidence Interval|Geometric Mean
2562139|NCT02641067|Primary|Plasma Concentration of Doravirine at 24 Hours Postdose (C24)|Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.|24 hours postdose|All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||nM||95% Confidence Interval|Geometric Mean
2562140|NCT02641067|Primary|Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞) of Doravirine|Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 12, 24, 48, 72 hours post-dose for all participants; and 96 hours post-dose for participants with severe renal impairment|All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||μM•hr||95% Confidence Interval|Geometric Mean
2562141|NCT02640755|Secondary|Best Percentage Change in Tumour Size From Baseline|Assessment of anti-tumour activity through measurement of tumour lesions. Tumour size was defined as the sum of the lengths of the longest diameters of the RECIST 1.1 target lesions.|RECIST 1.1 assessments were performed pre-dose at screening and then once every 8 weeks relative to the start of treatment in the Multiple Dose Period.|The efficacy analysis population consisted of all patients who received at least one dose of study treatment and had a baseline tumour assessment. Patients with available data are presented.|||Percentage change in tumour size||Full Range|Median
2562142|NCT02640755|Secondary|Best Overall Response (BOR) Assessment|"Anti-tumour activity through assessment of BOR. BOR was defined for each patient as follows according to the RECIST 1.1 criteria:~Complete Response (CR): Disappearance of all target lesions since baseline. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions.~Stable Disease (SD): Any cases that do not qualify for either PR or progressive disease (PD).~PD: At least a 20% increase in the sum of the diameters of target lesions. BOR for each patient was determined as the best response recorded from the day study treatment started until progression or until the last evaluable RECIST tumour assessment in the absence of progression."|RECIST 1.1 assessments were performed pre-dose at screening and then once every 8 weeks relative to the start of treatment in the Multiple Dose Period.|The efficacy analysis population consisted of all patients who received at least one dose of study treatment and had a baseline tumour assessment.|||Participants|||Number
2562143|NCT02640755|Secondary|Number of AEs Experienced by Patients.|AEs (including serious AEs [SAEs]) were collected from the time of informed consent (Visit 1) and throughout the study, including the 30-day follow-up. The numbers of patients experiencing any AEs and SAEs, causally related AEs and SAEs, and SAEs which were fatal are presented.|From Day 1 of the Single Dose Period to 30 days after the last dose of AZD2014 administered in the Multiple Dose Period.|The safety analysis population consisted of all patients who received at least one dose of AZD2014 (radiolabelled or non-radiolabelled).|||Participants|||Number
2562144|NCT02640755|Primary|Cumulative Percentage of Total [14C] Radioactivity Excreted in Stool as a Percentage of the Dose (fe Cum%[f])|"fe cum%(f) by the end of each collection period is presented following administration of [14C]-AZD2014.~Radioactivity excreta data for 1 patient was not included due to technical issues with radioactivity sample collection."|Stool was collected during the following periods: 0-6, 6-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||Cumulative % of total [14C]-AZD2014 dose||Standard Deviation|Mean
2562145|NCT02640755|Primary|Cumulative Percentage of Total [14C] Radioactivity Excreted in Urine as a Percentage of the Dose (fe Cum%[R])|"fe cum%(R) by the end of each collection period is presented following administration of [14C]-AZD2014.~Radioactivity excreta data for 1 patient was not included due to technical issues with radioactivity sample collection."|Urine was collected during the following periods: 0-6, 6-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||Cumulative % of total [14C]-AZD2014 dose||Standard Deviation|Mean
2562146|NCT02640755|Primary|Renal Clearance (CL[R]) of AZD2014 From Plasma.|CL(R) of AZD2014 from plasma up to 168 h post-dose.|Blood samples collected: Day 1 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 32, 48, 72, 96, 120, 144 and 168 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2562355|NCT02639338|Secondary|Change From Baseline in HCV RNA||Weeks 1, 2, 4, 8 and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2562147|NCT02640755|Primary|Fraction of AZD2014 Excreted in Urine as a Percentage of the Dose (fe%[R])|Mean fe%(R) values per urine collection period are presented as a percentage of the total [14C]-AZD2014 dose administered on Day 1.|Urine was collected during the following periods: 0-6, 6-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144 and 144-168 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||% of total [14C]-AZD2014 dose||Standard Deviation|Mean
2562148|NCT02640755|Primary|Ratio of AZD2014 Concentration to Total Radioactivity Concentration in Saliva|The mean ratios of saliva AZD2014 to saliva radioactivity concentrations are presented for the timepoints of saliva collection up to 10 hours post-dose. Geometric mean ratios were not calculated after 10 hours. Radioactivity excreta data for 1 patient was not included due to technical issues with radioactivity sample collection.|Saliva was collected at 1, 2, 4, 6, 8 and 10 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||ng/mL:ngEq/mL||Geometric Coefficient of Variation|Geometric Mean
2562149|NCT02640755|Primary|Ratio of Whole Blood Total Radioactivity to Plasma Total Radioactivity|The mean ratios of whole blood total radioactivity to plasma total radioactivity are presented for the timepoints of sample collection up to 12 hours post-dose. Geometric mean ratios were not calculated after 12 hours.|Blood samples collected: Day 1 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post [14C]-AZD2014 dose.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||ngEq/mL:ngEq/mL||Geometric Coefficient of Variation|Geometric Mean
2562150|NCT02640755|Primary|T(Last) for [14C] Radioactivity in Whole Blood and Saliva|Mean [14C] radioactivity t(last) values in whole blood and saliva following administration of [14C]-AZD2014 on Day 1 are presented.|Blood samples collected: Day 1 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 32, 48, 72, 96, 120, 144 and 168 h post [14C]-AZD2014 dose. Saliva was collected at 1, 2, 4, 6, 8, 10, 12 and 24 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||h||Geometric Coefficient of Variation|Geometric Mean
2562151|NCT02640755|Primary|Tmax for [14C] Radioactivity in Whole Blood and Saliva|[14C] radioactivity tmax in whole blood and saliva following administration of [14C]-AZD2014 on Day 1 is presented .|Blood samples collected: Day 1 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 32, 48, 72, 96, 120, 144 and 168 h post [14C]-AZD2014 dose. Saliva was collected at 1, 2, 4, 6, 8, 10, 12 and 24 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||h||Full Range|Median
2562152|NCT02640755|Primary|Cmax for Total [14C] Radioactivity in Whole Blood and Saliva|Mean [14C] radioactivity Cmax values in whole blood and saliva following administration of [14C]-AZD2014 on Day 1 are presented.|Blood samples collected: Day 1 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 32, 48, 72, 96, 120, 144 and 168 h post [14C]-AZD2014 dose. Saliva was collected at 1, 2, 4, 6, 8, 10, 12 and 24 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||ngEq/mL||Geometric Coefficient of Variation|Geometric Mean
2562153|NCT02640755|Primary|Half-life Associated With Terminal Slope (lambda_z) of a Semi-logarithmic Concentration-time Curve (t1/2[lambda_z]) for AZD2014 in Plasma|The mean t1/2(lambda_z) for AZD2014 in plasma following administration of [14C]-AZD2014 on Day 1 is presented.|Blood samples collected: Day 1 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 32, 48, 72, 96, 120, 144 and 168 h ost [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||h||Geometric Coefficient of Variation|Geometric Mean
2562154|NCT02640755|Primary|Terminal Elimination Rate Constant (lambda_z) for AZD2014 in Plasma|The mean lambda_z of AZD2014 in plasma following administration of [14C]-AZD2014 on Day 1 is presented.|Blood samples collected: Day 1 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 32, 48, 72, 96, 120, 144 and 168 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2562155|NCT02640755|Primary|Apparent Volume of Distribution at Steady State (Vss/F) for AZD2014 in Plasma|The mean Vss/F of AZD2014 in plasma following administration of [14C]-AZD2014 on Day 1 is presented.|Blood samples collected: Day 1 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 32, 48, 72, 96, 120, 144 and 168 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||L||Geometric Coefficient of Variation|Geometric Mean
2562356|NCT02639338|Secondary|Percentage of Participants With HCV RNA < LLOQ On Treatment||Weeks 1, 2, 4, 8 and 12|Percentage of participants in Full Analysis Set with on-treatment data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2562156|NCT02640755|Primary|Mean Residence Time (MRT) of AZD2014|The MRT of AZD2014 in plasma following administration of [14C]-AZD2014 on Day 1 is presented.|Blood samples collected: Day 1 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 32, 48, 72, 96, 120, 144 and 168 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||h||Geometric Coefficient of Variation|Geometric Mean
2562157|NCT02640755|Primary|Apparent Total Body Clearance (CL/F) of AZD2014|The mean CL/F of AZD2014 in plasma following administration of [14C]-AZD2014 on Day 1 is presented.|Blood samples collected: Day 1 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 32, 48, 72, 96, 120, 144 and 168 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2562158|NCT02640755|Primary|Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t]) for AZD2014 in Plasma and Saliva|Mean AUC(0-t) values in plasma and saliva for AZD2014 following administration of [14C]-AZD2014 on Day 1 are presented.|Blood samples collected: Day 1 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 32, 48, 72, 96, 120, 144 and 168 h post [14C]-AZD2014 dose. Saliva was collected at 1, 2, 4, 6, 8, 10, 12 and 24 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2562159|NCT02640755|Primary|Area Under the Plasma Concentration-time Curve (AUC) for AZD2014|Mean AUC for AZD2014 following administration of [14C]-AZD2014 on Day 1 is presented.|Blood samples collected: Day 1 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 32, 48, 72, 96, 120, 144 and 168 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2562160|NCT02640755|Primary|Time to Last Measurable Concentration (t[Last]) for AZD2014 in Plasma and Saliva|AZD2014 t(last) values in plasma and saliva following administration of [14C]-AZD2014 on Day 1 are presented.|Blood samples collected: Day 1 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 32, 48, 72, 96, 120, 144 and 168 h post [14C]-AZD2014 dose. Saliva was collected at 1, 2, 4, 6, 8, 10, 12 and 24 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||h||Geometric Coefficient of Variation|Geometric Mean
2562161|NCT02640755|Primary|Time to Maximum Observed Concentration (Tmax) for AZD2014 in Plasma and Saliva|AZD2014 Tmax values for plasma and saliva following administration of [14C]-AZD2014 on Day 1 are presented.|Blood samples collected: Day 1 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 32, 48, 72, 96, 120, 144 and 168 h post [14C]-AZD2014 dose. Saliva was collected at 1, 2, 4, 6, 8, 10, 12 and 24 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||h||Full Range|Median
2562162|NCT02640755|Primary|Maximum Observed Concentration (Cmax) of AZD2014 in Plasma and Saliva|Mean AZD2014 Cmax values in plasma and saliva following administration of [14C]-AZD2014 on Day 1 are presented.|Blood samples collected: Day 1 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 32, 48, 72, 96, 120, 144 and 168 h post [14C]-AZD2014 dose. Saliva was collected at 1, 2, 4, 6, 8, 10, 12 and 24 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2562163|NCT02640755|Primary|Cumulative Percentage of [14C]-AZD2014 Recovered by Day 8|"The mean cumulative percentage of [14C]-AZD2014 dose recovered as total radioactivity by the end of the Single Dose Period (Day 1 - 8) is presented. The total [14C] radioactivity in plasma was converted to concentration equivalents of AZD2014 based on the actual specific activity of the dose.~Radioactivity excreta data for 1 patient was not included due to technical issues with radioactivity sample collection."|From pre-dose Day 1 to Day 8 of the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||Percentage of dose administered||Standard Deviation|Mean
2562164|NCT02640755|Primary|Total Radioactivity Concentrations in Blood Following Administration of [14C]-AZD2014|The mean concentrations of total radioactivity in blood collected from each patient who received a single oral dose of 125 mg [14C]-AZD2014 are presented for time points of blood sampling up to 12 hours post-dose. Geometric mean concentrations were not quantifiable after 12 hours. The total [14C] radioactivity in plasma was converted to concentration equivalents of AZD2014 based on the actual specific activity of the dose.|Blood samples collected: Day 1 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||ngEq/mL||Geometric Coefficient of Variation|Geometric Mean
2562165|NCT02640755|Primary|AZD2014 Concentrations in Saliva Following Administration of [14C]-AZD2014|The mean concentrations of AZD2014 in saliva collected from each patient who received a single oral dose of 125 mg [14C]-AZD2014 are presented for time points of plasma sampling up to 12 hours post-dose. Geometric mean concentrations were not quantifiable after 12 hours.|Saliva was collected at 1, 2, 4, 6, 8, 10 and 12 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2562166|NCT02640755|Primary|Total Radioactivity Concentrations in Saliva Following Administration of [14C]-AZD2014|The mean concentrations of total radioactivity in saliva collected from each patient who received a single oral dose of 125 mg [14C]-AZD2014 are presented for time points of saliva collection up to 12 hours post-dose. Geometric mean concentrations were not quantifiable after 12 hours. The total [14C] radioactivity in saliva was converted to concentration equivalents of AZD2014 based on the actual specific activity of the dose.|Saliva was collected at 1, 2, 4, 6, 8, 10 and 12 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||ngEq/mL||Geometric Coefficient of Variation|Geometric Mean
2562167|NCT02640755|Primary|AZD2014 Concentrations in Plasma Following Administration of [14C]-AZD2014|The mean concentrations of AZD2014 in plasma collected from each patient who received a single oral dose of 125 mg [14C]-AZD2014 are presented for time points of plasma sampling up to 24 hours post-dose. Geometric mean concentrations were not quantifiable after 24 hours.|Blood samples collected: Day 1 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 h post [14C]-AZD2014 dose in the Single Dose Period.|The PK analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2562168|NCT02640755|Primary|Total Radioactivity in Plasma Following Administration of [14C]-AZD2014|The mean concentrations of total radioactivity in plasma collected from each patient who received a single oral dose of 125 mg [14C]-AZD2014 are presented for time points of plasma sampling up to 48 hours post-dose. Geometric mean concentrations were not quantifiable after 48 hours. The total [14C] radioactivity in plasma was converted to concentration equivalents of AZD2014 based on the actual specific activity of the dose.|Blood samples collected: Day 1 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 32 and 48 hours (h) post [14C]-AZD2014 dose in the Single Dose Period.|The Pharmacokinetic (PK) analysis population consisted of all evaluable patients who were dosed with [14C]-AZD2014 in Cycle 0 and who had reportable and evaluable PK concentration data. Patients were excluded if they vomited at or before 3 hours post-dosing or had identified procedural or scientific deficiency as being likely to impact the PK data.|||nanogram equivalent/millilitre (ngEq/mL)||Geometric Coefficient of Variation|Geometric Mean
2562169|NCT02640625|Secondary|Alterations in Systemic Markers of Immune Activation|Explorative assays on soluble inflammation markers and lymphoid cells activation status (Unit of Measure: Descriptive)|8 weeks||2020-12-31|12/2020||||
2562170|NCT02640625|Secondary|Alterations in Systemic T Cell Intracellular Signaling|Explorative assays on T cell receptor signaling mechanism (Unit of Measure: Frequency)|8 weeks||2020-11-30|11/2020||||
2562171|NCT02640625|Secondary|Alterations in Lamina Propria T Cell Subsets|Explorative assays on T cell subsets distribution and function (Unit of Measure: Frequency)|8 weeks||2020-12-31|12/2020||||
2562172|NCT02640625|Secondary|Alterations in Epithelial Gene Expression|Explorative (Unit of Measure: Descriptive)|8 weeks||2020-12-31|12/2020||||
2562173|NCT02640625|Secondary|Alteration in Gut Microbiota Composition|Explorative (Unit of Measure: Descriptive)|8 weeks||2020-12-31|12/2020||||
2562174|NCT02640625|Primary|Delta Blood CD4 Count|Unit of Measure: cells/microL|8 weeks||||cells/microL||Full Range|Median
2562175|NCT02640625|Primary|Delta HIV Viral Load|Unit og Measure: copies/mL|8 weeks||||copies/mL||Full Range|Median
2562176|NCT02640625|Primary|Adverse Effects|Number of Participants who Experienced Adverse Effects|10 weeks||||Participants|||Count of Participants
2562177|NCT02640612|Secondary|Percentage of Patients With European League Against Rheumatism (EULAR) Response (Good Response, Moderate Response, or no Response) at Week 48|"Percentage of patients with European League Against Rheumatism (EULAR) response (good response, moderate response, or no response) were calculated at Week 48 for assessment of this outcome measure.~No response: If improvement in DAS28 (ESR) at w48 <=0.6, or if DAS28(ESR) at w48 >5.1 and improvement is in range >0.6 to <1.2.~Moderate response: If DAS28(ESR) at w48 <=5.1 and improvement is in range >0.6 to <1.2, or, DAS28(ESR) at w48 >3.2 and improvement is in range >=1.2.~Good response: If DAS28(ESR) at w48 <=3.2 and improvement >=1.2."|Week 48.|FAS|||Percentage of patients (%)|||Number
2562178|NCT02640612|Secondary|Percentage of Patients Who Meet the American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) Definition of Remission at Week 48|"The ACR/EULAR remission criteria were based on a Boolean definition. At any time point, the patient must have satisfied all of the following:~Tender joint count (TJC) ≤ 1~Swollen joint count (SJC) ≤ 1~C-reactive protein (CRP) ≤ 1 mg/dL~Patient global assessment of disease activity ≤ 10 (on a 0 to 100 scale) For TJC and SJC, use of a 28-joint count may have missed actively involved joints, particularly in the feet and ankles. It was preferable to include the feet and ankles when evaluating remission."|Week 48.|FAS|||Percentage of patients (%)|||Number
2562214|NCT02640157|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Superiority of Arm A to Arm B|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. Per statistical analysis plan to adjust for multiplicity among the primary and first secondary hypothesis tests, the test for superiority of Arm A to Arm B was not conducted.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2562179|NCT02640612|Secondary|Percentage of Patients Meeting American College of Rheumatology (ACR) 20% Response Criteria at Week 48|The proportion of patients meeting the ACR20 response criteria was assessed. A patient had an ACR20 response if all of the following occurred: A ≥ 20 % improvement in the swollen joint count (66 joints), A ≥ 20 % improvement in the tender joint count (68 joints), A ≥ 20 % improvement in at least three of the following assessments: Patient's assessment of pain, Patient's global assessment of disease activity (equivalent to the General Health component of the Disease Activity Score ([DAS]), Physician's global assessment of disease activity, Patient's assessment of physical function, as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) Acute phase reactant (C-reactive protein [CRP]).|Week 48.|FAS, All patients who discontinue treatment, are lost-to-follow-up or have any severe violation related to any therapy that may significantly impact efficacy assessment prior to the secondary endpoint assessment will be considered as a non-responder (NRI).|||Percentage of patients (%)|||Number
2562180|NCT02640612|Secondary|Change From Baseline in Disease Activity Score in 28 Joints (DAS 28) by Erythrocyte Sedimentation Rate (ESR) at Week 48|The DAS28 (ESR) score was derived using the following formulae: DAS28 (ESR) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.7*ln(ESR) Where: • TJC28 = 28 joint count for tenderness • SJC28 = 28 joint count for swelling • GH = General Health component of the DAS (patient's global assessment of disease activity) • Ln (ESR) = natural logarithm of ESR. Last observation carried forward (LOCF) is the method used for handling missing components post baseline. Baseline for this trial was taken from the baseline of 1297.2. Improvement in DAS28 was also categorized using the European League Against Rheumatism (EULAR) response criteria. The DAS28 provides a number on a scale from 0 to 10 where higher values mean a higher disease activity. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6.|Baseline and Week 48.|FullAnalysisSet(FAS) includes patients from the all subjects assigned set who received at least 1 dose of trial drug in Trial 1297.3 and had at least 1 DAS28(ESR and C-reactive protein) or american college of rheumatology 20% response criteria (ACR20) measured during trial. Classified according to randomized/rerandomized treatments of trial 1297.2.|||Unit on scale||Standard Deviation|Mean
2562181|NCT02640612|Primary|Percentage of Patients With Drug-related Adverse Events (AEs) During the Treatment Phase|"The analysis of AEs was based on the concept of treatment-emergent AEs (TEAEs). Thus, all AEs with an onset after the first dose of trial drug up to a period of ten weeks after the last dose of trial drug were assigned to the current treatment for evaluation. Investigator assessed drug related AEs were AEs with a relationship to drug ticked yes according to the Investigator."|From the first drug administration until 10 weeks after the last drug administration, up to 58 weeks.|Safety Analysis Set (SAF): All patients who received at least 1 dose during trial 1297.3. In the event of doubt as to whether a patient was treated or not, they were assumed to have been treated for the purposes of analysis, and thus included in the SAF. Patients were classified according to randomized/re-randomized treatments of Trial 1297.2.|||Percentage of patients (%)|||Number
2562182|NCT02640573|Primary|Fetal Hemoglobin Response to HU|Change in HbF on hydroxyurea from baseline|Baseline to 6 months|Baseline QoL only; no subsequent values obtained.||||||
2562183|NCT02640547|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment|"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems."|Baseline, end of treatment, and at 12 and 24 weeks after end of treatment|Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants with available data at baseline and each time point are included.|||percent impairment||Inter-Quartile Range|Median
2562184|NCT02640547|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)|"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total work productivity impairment (TWP) indicates the percentage of overall work impairment due to health problems."|Baseline, end of treatment, and at 12 and 24 weeks after end of treatment|Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants who were employed with available data at baseline and each time point are included.|||percent impairment||Inter-Quartile Range|Median
2562185|NCT02640547|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism|"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Presenteeism indicates the percentage of impairment while working due to health problems."|Baseline, end of treatment, and at 12 and 24 weeks after end of treatment|Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants who were employed with available data at baseline and each time point are included.|||percent impairment||Inter-Quartile Range|Median
2562234|NCT02639637|Secondary|Low Frequency Variability of Blood Pressure Activity|Measured using the VITAL-GARD 450c monitor Ivy Biomedical Systems, Branford, CT, USA)|Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days were separated by five weeks, a four-week washout and one-week treatment period.||||mm Hg2||Standard Deviation|Mean
2562186|NCT02640547|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism|"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Absenteeism indicates the percentage of work time missed due to health problems."|Baseline, end of treatment, and at 12 and 24 weeks post treatment|Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants who were employed with available data at baseline and each time point are included.|||percent impairment||Inter-Quartile Range|Median
2562187|NCT02640547|Secondary|Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score|"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. with a separate visual analog scale (VAS).~The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable)."|Baseline, end of treatment, and at 12 and 24 weeks after end of treatment|Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± RBV according to standard of care and within local label recommendations for their specific disease characteristics. Participants with available data at baseline and each time point are included.|||units on a scale||95% Confidence Interval|Least Squares Mean
2562188|NCT02640547|Secondary|Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score|"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS).~Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status."|Baseline, end of treatment, and at 12 and 24 weeks after end of treatment|Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics. Participants with available data at baseline and each time point are included.|||units on a scale||95% Confidence Interval|Least Squares Mean
2562189|NCT02640547|Secondary|Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies||From first dose of study drug through 30 days after last dose. The median duration of treatment was 84 days.|All enrolled participants who received at least one dose of the ABBVIE REGIMEN.|||Participants|||Count of Participants
2562190|NCT02640547|Secondary|Number of Participants Who Received Concomitant Medications|Concomitant medication other than for chromic hepatitis C used from the time when the decision was made to initiate treatment with the ABBVIE REGIMEN until after the last dose.|From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen|All enrolled participants who received at least one dose of the ABBVIE REGIMEN.|||Participants|||Count of Participants
2562191|NCT02640547|Secondary|Number of Participants With Comorbidities||Baseline|Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics.|||Participants|||Count of Participants
2562192|NCT02640547|Secondary|Percentage of the Ribavirin (RBV) Dose Taken in Relation to the Target Dose of RBV|"Adherence to study treatment was calculated as:~Cumulative dose taken / (initial prescribed dose * planned duration)"|From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen|All enrolled participants who received at least one dose of the ABBVIE REGIMEN that included ribavirin|||Participants|||Count of Participants
2562193|NCT02640547|Secondary|Percentage of the Direct Acting Antiviral (DAA) Dose Taken in Relation to the Target Dose of DAA|"Adherence to study treatment was calculated as:~Cumulative dose taken / (initial prescribed dose * planned duration)"|From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen|All enrolled participants who received at least one dose of the ABBVIE REGIMEN.|||Participants|||Count of Participants
2562194|NCT02640547|Secondary|Assigned Treatment Regimen|Treatment regimen was assigned by the physician according to local practice and label. Participants could receive two direct-acting antiviral (DAA) drugs (paritaprevir/ritonavir and ombitasvir) plus ribavirin (RBV) for either 12 or 24 weeks, or three DAAs (paritaprevir/ritonavir, ombitasvir, and dasabuvir) with or without RBV for 12 or 24 weeks.|Baseline|Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics.|||Participants|||Count of Participants
2562195|NCT02640547|Secondary|Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment|"SVR12 non-response was categorized according to the following:~Relapse, defined as HCV RNA < 50 IU/mL at EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened);~Death;~Premature treatment discontinuation with no on-treatment virological failure;~Missing SVR12 data and/or none of the above criteria."|12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)|Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics.|||percentage of participants|||Number
2562235|NCT02639637|Secondary|DPP4 Activity|DPP4 activity was measured by detection of cleavage of a colorimetric substrate.|Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days were separated by five weeks, a four-week washout and one-week treatment period.||||nmol/ml/min||Standard Deviation|Mean
2565276|NCT02599766|Secondary|Mood 4: Satisfaction Therapist Rating|Satisfaction during the therapy sessions was assessed by the therapist using a VAS ranging from 0 (unsatisfied) to 160 (satisfied).|6 weeks||||units on a scale||Standard Deviation|Mean
2562196|NCT02640547|Secondary|Percentage of Participants in the Core Population With Sufficient Follow-up Data for SVR12 Who Achieved Sustained Virological Response 12 Weeks Post-treatment (SVR12)|"Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.~The core population with sufficient follow-up data regarding SVR12 included all core population participants who~had evaluable HCV RNA data ≥ 70 days after the last actual dose of the ABBVIE regimen,~or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline~or had HCV RNA < 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 70 days after the last actual dose of the ABBVIE regimen due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure."|12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)|The core population with sufficient follow-up data regarding SVR12|||percentage of participants||95% Confidence Interval|Number
2562197|NCT02640547|Secondary|Percentage of Participants Achieving Sustained Virological Response 24 Weeks Post-treatment (SVR24)|Sustained virologic response is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug.|24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen)|Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics.|||percentage of participants||95% Confidence Interval|Number
2562198|NCT02640547|Secondary|Percentage of Participants With a Rapid Virological Response at Week 4|"Rapid virological response at week 4 (RVR4) was defined as participants with HCV RNA < 50 IU/mL at week 4.~Due to the non-interventional character of the study, many participants did not have an HCV RNA assessed at treatment week 4 since this is not generally recommended in the label. Participants with missing data at the RVR4 time point were considered as virological failures."|Week 4|Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics.|||percentage of participants||95% Confidence Interval|Number
2562199|NCT02640547|Secondary|Percentage of Participants With Breakthrough|Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.|12 or 24 weeks (depending on the treatment regimen)|Participants who received adequate treatment with the ABBVIE REGIMEN ± RBV according to standard of care and within local label recommendations for their specific disease characteristics, who had at least one undetectable HCV RNA measurement on-treatment and at least one measurement on-treatment thereafter|||percentage of participants||95% Confidence Interval|Number
2562200|NCT02640547|Secondary|Percentage of Participants With Relapse|Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.|End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.|Participants who received adequate treatment with the ABBVIE REGIMEN ± RBV according to standard of care and within local label recommendations for their specific disease characteristics, and with VR at actual EOT and who completed treatment, and had ≥ 1 HCV RNA measurement ≥ 70 days post-treatment or were a treatment failure between EOT and day 70|||percentage of participants||95% Confidence Interval|Number
2562201|NCT02640547|Secondary|Percentage of Participants Achieving Virological Response at End of Treatment|Virologic response is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.|End of treatment (week 12 or 24 depending on the treatment regimen)|Enrolled participants who received adequate treatment with paritaprevir/r and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin according to standard of care and within local label recommendations for their specific disease characteristics.|||percentage of participants||95% Confidence Interval|Number
2562202|NCT02640547|Primary|Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)|Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.|12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)|Enrolled participants who received adequate treatment with paritaprevir/ritonavir (r) and ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) according to standard of care and within local label recommendations for their specific disease characteristics.|||percentage of participants||95% Confidence Interval|Number
2562203|NCT02640482|Secondary|Percentage of Participants With SVR12 in Arm A DB Active Drug With Prior SOF + RBV ± pegIFN Failure|SVR12 was defined as HCV RNA level <LLOQ 12 weeks after the last dose of active study drug.|12 weeks after the last actual dose of active study drug|All randomized participants who received at least one dose of study drug in Arm A DB with prior SOF + RBV ± pegIFN failures.|||percentage of participants|||Number
2562204|NCT02640482|Secondary|Percentage of Participants With Post-treatment Relapse in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of DB treatment and 12 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|Between End of Treatment (Week 12) and 12 weeks after the last dose of Arm A DB active drug (up to Week 24)|All randomized participants who received at least 1 dose of study drug in Arm A DB with HCV RNA < LLOQ at the final treatment visit who completed the DB treatment, excluding participants with prior SOF + RBV ± pegIFN failures.|||percentage of participants||95% Confidence Interval|Number
2562205|NCT02640482|Secondary|Percentage of Participants With On-treatment Virologic Failure in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value of post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Up to Week 12 post baseline|All randomized participants who received at least one dose of study drug in Arm A DB excluding participants with prior SOF + RBV ± pegIFN failures.|||percentage of participants||95% Confidence Interval|Number
2562458|NCT02638259|Secondary|Treatment Period 2 : Proportion of Patients Achieving DAS28 < 2.6 at Weeks 36 and 48;|percentage of participants in DAS28-ESR categories up to week 48|week 36 and week 48|Treatment period 2 per protocol set. Patients with data available|||Participants|||Count of Participants
2562206|NCT02640482|Secondary|Percentage of Participants With SVR12 in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures: Superiority Analysis|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. The secondary efficacy endpoint was the superiority of the percentage of participants who achieved SVR12 in Arm A Double Blind (DB) Active Drug excluding prior SOF + RBV ± pegIFN failures compared with the historical control rate for patients treated with the current standard of care (SOF + RBV for 12 weeks). As pre-specified in the study protocol, the primary outcome measure and the secondary outcome measure are not tested independently from each other. Rather, the two measures are ranked in a fixed sequential testing procedure that only if success was demonstrated for the primary outcome (i.e. non-inferiority test of Arm A SVR12 rate to the standard of care) did we test the first secondary outcome (i.e. superiority test of Arm A SVR12 rate to the standard of care).|12 weeks after the last actual dose of active study drug|All randomized participants who received at least one dose of study drug in Arm A DB excluding participants with prior SOF + RBV ± pegIFN failures.|||percentage of participants|||Number
2562207|NCT02640482|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures: Noninferiority Analysis|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was the noninferiority of the percentage of participants who achieved SVR12 in Arm A Double Blind (DB) Active Drug excluding prior sofosbuvir (SOF) + ribavirin (RBV) ± pegylatedinterferon (pegIFN) failures compared with the historical control rate for patients treated with the current standard of care (SOF + RBV for 12 weeks).|12 weeks after the last actual dose of active study drug|All randomized participants who received at least one dose of study drug in Arm A DB excluding participants with prior SOF + RBV ± pegIFN failures.|||percentage of participants|||Number
2562208|NCT02640404|Primary|Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years)|Solicited systemic reactions: Fever (Grade 1: >=38.0 degree Celsius to <=38.4 degree Celsius; Grade 2: >=38.5 degree Celsius to <=38.9 degree Celsius; Grade 3: >=39.0 degree Celsius), headache, malaise and myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any of the Grade 1, 2 or 3 systemic reactions and Grade 3 systemic reactions were reported.|Within 7 days post-vaccination|Safety analysis set included all participants who received at least 1 dose of study vaccine.|||Participants|||Count of Participants
2562209|NCT02640404|Primary|Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months)|Solicited systemic reactions: Fever (Grade 1: >=38.0 degree Celsius to <=38.5 degree Celsius; Grade 2: >38.5 degree Celsius to <=39.5 degree Celsius; Grade 3: >39.5 degree Celsius), Vomiting (Grade 1: 1 episode per 24 hours, Grade 2: 2-5 episodes per 24 hours, Grade 3: >=6 episodes per 24 hours), Crying abnormal (Grade 1: <1 hour; Grade 2: 1-3 hours; Grade 3: >3 hours), Drowsiness (Grade 1: sleepier than usual or less interested in surroundings; Grade 2: Not interested in surroundings or did not wake up for a feed / meal; Grade 3: Sleeping most of the time or difficult to wake up), Appetite loss (Grade 1: eating less than normal; Grade 2: missed 1 or 2 feeds / meals completely; Grade 3: refuses >=3 feeds / meals or refuses most feeds / meals), Irritability (Grade 1: easily consolable; Grade 2: requiring increased attention; Grade 3: inconsolable). Number of participants with any of the Grade 1, 2 or 3 systemic reactions and Grade 3 systemic reactions were reported.|Within 7 days post-vaccination 1, Within 7 days post-vaccination 2|Safety analysis set included all participants who received at least 1 dose of study vaccine.|||Participants|||Count of Participants
2562210|NCT02640404|Primary|Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years)|Solicited injection (Inj.) site reactions in children (2-11 years), adolescents and adults (12-55 years): Tenderness/Pain (Grade 1: easily tolerated [children], no interference with activity [adolescents and adults]; Grade 2: sufficiently discomforting [children], some interference[adolescents and adults]; Grade 3: unable to perform usual activities[children]; significant interference with daily activities [adolescents and adults]), Erythema and Swelling (Grade 1: >0 to<25 mm [children], >=25 to <=50 mm [adolescents and adults]; Grade 2: >=25 to <50 mm [children], >=51 to <=100 mm [adolescents and adults], Grade 3: >=50 mm [children]; >100 mm[adolescents and adults]). Number of participants with any of Grade 1, 2 or 3 solicited injection-site reactions and Grade 3 solicited injection-site reactions were reported.|Within 7 days post-vaccination|Safety analysis set included all participants who received at least 1 dose of study vaccine.|||Participants|||Count of Participants
2562211|NCT02640404|Primary|Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months)|Solicited injection (Inj.) site reactions: Tenderness/Pain (Grade 1: minor reaction when Inj. site touched; Grade 2: cries/protests when Inj. site touched; Grade 3: cries when injected limb moved, or the movement of the injected limb is reduced), Erythema and Swelling (Grade 1: >0 to <25 mm, Grade 2: >=25 to <50 mm, Grade 3: >=50 mm). Number of participants with any of the Grade 1, 2 or 3 solicited injection-site reactions and Grade 3 solicited injection-site reactions were reported.|Within 7 days post-vaccination 1, Within 7 days post-vaccination 2|Safety analysis set included all participants who received at least 1 dose of study vaccine.|||Participants|||Count of Participants
2562212|NCT02640157|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit|||percentage of participants||95% Confidence Interval|Number
2562213|NCT02640157|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Treatment weeks 1, 2, 4, 8 (end of treatment for Arm C), and 12 (end of treatment for Arms A and B) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population)|||percentage of participants||95% Confidence Interval|Number
2562215|NCT02640157|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm C to Arm A|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. If the first primary efficacy objective (noninferiority of Arm A to Arm B) was achieved, then the second primary efficacy objective, noninferiority in the percentage of participants achieving SVR12 of the 8-week regimen (Arm C) to the 12-week regimen (Arm A) was to be tested. Noninferiority was defined as: a) the lower bound of the 95% CI for the difference was above the noninferiority margin of -6% and the lower bound of the 95% CI for the SVR12 rate within Arm C was greater than 92%, OR b) the lower bound of the 95% CI for the difference was below the noninferiority margin of -6% and the lower bound of the 97.5% CI for the SVR12 rate within Arm C was greater than 92%, OR c) the lower bound of the 97.5% CI for the difference was above the noninferiority margin of -6% and the lower bound of the 95% CI for the SVR12 rate within Arm C was below 92%.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2562216|NCT02640157|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12): Noninferiority of Arm A to Arm B|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ] 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority in the percentage of participants achieving SVR12 of the 12-week regimen (Arm A) to the standard of care (Arm B: 12 weeks of treatment with sofosbuvir [SOF] + daclatasvir [DCV]), defined as: a) the lower bound of the 95% confidence interval (CI) for the difference was above the non-inferiority margin of -6% and the lower bound of the 95% CI for the SVR12 rate within Arm A was greater than 92%; OR b) the lower bound of the 95% CI for the difference was below the non-inferiority margin of -6% and the lower bound of the 97.5% CI for the SVR12 rate within Arm A was greater than 92%; OR c) the lower bound of the 97.5% CI for the difference was above the non-inferiority margin of -6% and the lower bound of the 95% CI for the SVR12 rate within Arm A was below 92%.|12 weeks after the last actual dose of study drug|Intent-to-treat population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were counted as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2562217|NCT02640053|Secondary|Area Under the Curve (AUC) Per Assessment (aAUCpa) of Worst Pain (Item 1 on the Daily Post-Paclitaxel Questionnaire)|"Average Area Under the Curve (AUC) per assessment (aAUCpa) of worst pain (item 1 on the Daily Post-Paclitaxel Questionnaire; Please rate any aches/pain that are new since your last dose of paclitaxel, and that you think might be related to your chemotherapy treatment, by circling ONE number that best describes your aches/pain at its WORST in the last 24 hours.) over 1 week. Scores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL). The aAUCpa is the average of each AUC between each sequential assessment from day 2 through 7 following paclitaxel."|1 week|Patients who completed the Daily Post-Paclitaxel Questionnaire over the first week of paclitaxel were included in this analysis.|||Average(subscale value*assessment)||Full Range|Median
2562218|NCT02640053|Primary|Area Under the Curve (AUC) EORTC CIPN20 Shooting/Burning Pain in Toes or Feet Item Adjusting for Baseline|"Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Shooting/Burning Pain in Toes or Feet over 12 weeks adjusting for baseline (item 1; During the past week, did you have shooting or burning pain in your Toes or Feet?; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much). The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline."|Up to 12 weeks|Patients who completed the EORTC QLQ-CIPN20 at pre-treatment-initiation and at least once post-treatment initiation.|||Average(subscale value*assessment)||Full Range|Median
2562219|NCT02640053|Primary|Area Under the Curve (AUC) EORTC CIPN20 Shooting/Burning Pain in Fingers or Hands Item Adjusting for Baseline|"Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Shooting/Burning Pain in Fingers or Hands over 12 weeks adjusting for baseline (item 1; During the past week, did you have shooting or burning pain in your fingers or hands?; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much). The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline."|Up to 12 weeks|Patients who completed the EORTC QLQ-CIPN20 at pre-treatment-initiation and at least once post-treatment initiation.|||Average(subscale value*assessment)||Full Range|Median
2562220|NCT02640053|Primary|Area Under the Curve (AUC) EORTC CIPN20 Numbness Toes or Feet Item Adjusting for Baseline|"Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Numbness Toes or Feet over 12 weeks adjusting for baseline (item 1; During the past week, did you have numbness in your toes or feet?; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much). The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline."|Up to 12 weeks|Patients who completed the EORTC QLQ-CIPN20 at pre-treatment-initiation and at least once post-treatment initiation.|||Average(subscale value*assessment)||Full Range|Median
2562236|NCT02639637|Secondary|ACE Activity|ACE activity was measured using a commercially available assay (Olympus AU400/AU600, Alpco Diagnotics, Salem, NH.) The lower level of detection was 15 U/L and values below the level of detection were reported at half the level of detection.|Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days were separated by five weeks, a four-week washout and one-week treatment period.|Was not measured during the valsartan study days.|||U/L||Standard Deviation|Mean
2562221|NCT02640053|Primary|Area Under the Curve (AUC) EORTC CIPN20 Numbness Fingers or Hands Item Adjusting for Baseline|"Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Numbness Fingers or Hands over 12 weeks adjusting for baseline (item 1; During the past week, did you have numbness in your fingers or hands?; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much). The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline."|Up to 12 weeks|Patients who completed the EORTC QLQ-CIPN20 at pre-treatment-initiation and at least once post-treatment initiation.|||Average(subscale value*assessment)||Full Range|Median
2562222|NCT02640053|Primary|Area Under the Curve (AUC) EORTC CIPN20 Tingling Toes or Feet Item Adjusting for Baseline|"Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Tingling Toes or Feet over 12 weeks adjusting for baseline (item 1; During the past week, did you have tingling toes or feet?; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much). The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline."|Up to 12 weeks|Patients who completed the EORTC QLQ-CIPN20 at pre-treatment-initiation and at least once post-treatment initiation.|||Average(subscale value*assessment)||Full Range|Median
2562223|NCT02640053|Primary|Area Under the Curve (AUC) EORTC CIPN20 Tingling Fingers or Hands Item Adjusting for Baseline|"Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Tingling Fingers or Hands over 12 weeks adjusting for baseline (item 1; During the past week, did you have tingling fingers or hands?; 1=Not at all, 2=A little, 3=Quite a bit; and 4=Very much). The reported score was transform into 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the individual item is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline."|Up to 12 weeks|Patients who completed the EORTC QLQ-CIPN20 at pre-treatment-initiation and at least once post-treatment initiation.|||Average(subscale value*assessment)||Full Range|Median
2562224|NCT02640053|Primary|Area Under the Curve (AUC) EORTC CIPN20 Sensory Neuropathy Subscale Adjusting for Baseline|Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Sensory Neuropathy Subscale adjusting for baseline. The EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the subscale is calculated as the average of each AUC between each sequential assessment from pre-treatment-initiation to the week-12 assessment then subtract the corresponding baseline Sensory Neuropathy subscale score, with positive scores represent symptoms has improved from baseline and negative scores represent symptoms has worsen from baseline.|Up to 12 weeks|Patients who completed the EORTC QLQ-CIPN20 at pre-treatment-initiation and at least once post-treatment initiation.|||Average(subscale value*assessment)||Full Range|Median
2562225|NCT02639910|Other Pre-specified|Proportion of Patients With MRD-negativity|Proportion of patients who reached MRD-negativity in peripheral blood|2 years||||Participants|||Count of Participants
2562226|NCT02639910|Secondary|Maximum Plasma Concentration (Cmax) of MOR00208|Mean Cmax of tafasitamab (MOR00208) at Cycle 3 Day 15 (after the weekly dosing of tafasitamab in Cycles 1 to 3 including a loading dose at C1D4)|At Cycle 3 Day 15|All patients with available pharmacokinetic data for Cmax at Cycle 3 Day 15.|||ng/mL||Standard Deviation|Mean
2562227|NCT02639910|Secondary|Number of Participants With Treatment-emergent or Treatment-boosted Anti-MOR00208 Antibody Formation|Number of participants with treatment-emergent or treatment-boosted anti-MOR00208 (anti-tafasitamab) antibody formation|2 years||||Participants|||Count of Participants
2562228|NCT02639910|Secondary|Best Objective Response Rate (ORR)|ORR = complete response [CR] + partial response [PR]; Local Evaluation|2 years|Intention-to-treat patient population consists of all enrolled patients. As per study protocol all patients were required to have computed tomography (CT) scans of the neck, chest, abdomen and pelvis to determine tumor response. These were performed at screening, at Day 1 of Cycles 4, 7, 13, and 19, etc. and at end-of-treatment.|||Percentage of participants|||Number
2562229|NCT02639910|Primary|Incidence and Severity of Adverse Events (AEs)|For details please see Section of Adverse Events Overview|2 years||||Participants|||Count of Participants
2562230|NCT02639637|Secondary|Heart Rate||Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days were separated by five weeks, a four-week washout and one-week treatment period.||||beats per minute||Standard Deviation|Mean
2562231|NCT02639637|Secondary|Mean Arterial Pressure||Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days were separated by five weeks, a four-week washout and one-week treatment period.||||mm Hg||Standard Deviation|Mean
2562232|NCT02639637|Secondary|Venous tPA|Measured using an ELISA. This was measured in a few subjects. After it was determined that there was no change in net t-PA release it was not measured in the remainder.|Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days were separated by five weeks, a four-week washout and one-week treatment period.|This was measured in a few subjects. After it was determined that there was no change in net t-PA release it was not measured in the remainder.|||ng/mL||Standard Deviation|Mean
2562233|NCT02639637|Secondary|Arterial tPA|Measured using an ELISA.|Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days were separated by five weeks, a four-week washout and one-week treatment period.|This was measured in a few subjects. After it was determined that there was no change in net t-PA release it was not measured in the remainder.|||ng/mL||Standard Deviation|Mean
2562238|NCT02639637|Secondary|GLP-1|GLP--1 was not analyzed as subjects were studied in the fasting state.|Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days were separated by five weeks, a four-week washout and one-week treatment period.|GLP--1 was not analyzed as subjects were studied in the fasting state.||||||
2562239|NCT02639637|Secondary|Insulin|Plasma insulin measured by radioimmunoassay.|Measured at baseline (time 0) of each study day prior to the infusion of neuropeptide Y. Study days 1 and 2 were separated by five weeks, a four-week washout and one-week treatment period.|The comparison of sitagliptin and placebo were original to the study. Because the purpose of the sitagliptin and valsartan versus placebo and valsartan comparison was to further understand the mechanism for forearm blood flow effects it was not necessary to measure insulin in that added part of the study.|||microU/mL||Standard Deviation|Mean
2562240|NCT02639637|Secondary|NPY Metabolites|"NPY (3-36) concentration measured by micro ultra-hgih pressure liquid chromatography tandem mass spectrometry.~NPY (3-36) is the degradation product of NPY by dipeptidyl peptidase 4. It was measured only in the diabetics studied."|Measured after 5 min infusion of the 1.0 nmol/min dose of neuropeptide Y on study days 1 and 2. Study days 1 and 2 were separated by five weeks.|Because the purpose of measuring NPY metabolites was to assess whether sitagliptin blocks the formation of the metabolites, and because the analysis is laborious and costly, measurements were only completed in the diabetics studied.|||pmol/L||Standard Deviation|Mean
2562241|NCT02639637|Secondary|Venous Norepinephrine|Venous norepinephrine concentration measured by high-performance liquid chromatography|Measured at baseline (time 0) prior to the infusion of neuropeptide Y on each study day. Study days 1 and 2 were separated by five weeks.||||pg/mL||Standard Deviation|Mean
2562242|NCT02639637|Secondary|Arterial Norepinephrine|Arterial norepinephrine concentration measured by high-performance liquid chromatography.|Measured at baseline (time 0) prior to the infusion of neuropeptide Y on each study day. Study days 1 and 2 were separated by five weeks.||||pg/mL||Standard Deviation|Mean
2562243|NCT02639637|Primary|Forearm Blood Flow|Forearm blood flow measured by strain gauge plethysmography in response to 1.0 nmol/min neuropeptide Y, the highest dose that all received.|FBF measured after 5 min of the 1 nmol/min dose of neuropeptide Y on study days 1 and 2. Study days 1 and two were separated by five weeks.||||mL/min/100 mL||Standard Deviation|Mean
2562244|NCT02639559|Secondary|Median Peripheral Blood CD34+ Cell Count (Arm 1 Donor Only)||At 3-4 hours after BL-8040|Recipients are not evaluable for this outcome measure.|||CD34/microliters||Full Range|Median
2562245|NCT02639559|Secondary|Probability of Overall Survival After Transplantation of Hematopoietic Cells Mobilized With BL-8040 (Arm 2 Recipients Only)|-The time from Day 0 to death|Up to 3 years after transplantation||2022-04-30|04/2022||||
2562246|NCT02639559|Secondary|Probability of Event Free Survival After Transplantation of Hematopoietic Cells Mobilized With BL-8040 (Arm 2 Recipients Only)|-An event is defined as either graft failure, disease relapse as evidenced by hematologic, radiographic, or cytogenetic changes, or death. The event free survival is the time from Day 0 to occurrence of the first event.|Up to 3 years after transplantation||2022-04-30|04/2022||||
2562247|NCT02639559|Secondary|Incidence of Disease Relapse/Progression After Transplantation of Hematopoietic Cells Mobilized With BL-8040 (Arm 2 Recipients Only)|-Disease relapse occurs in recipients who entered transplant in CR. Progression occurs in recipients with existent disease at transplant who meet criteria for progressive disease post-transplant. A recipient will be considered relapsed when there is a recurrence of the original malignant disease after transplantation. Date of relapse/progression is defined as the date at which the first observation of hematologic, radiographic, or cytogenetic changes which signify progression/relapse is made|Up to 3 years after transplantation||2022-04-30|04/2022||||
2562248|NCT02639559|Secondary|Cumulative Incidence of Treatment-related Mortality After Transplantation of Hematopoietic Cells Mobilized With BL-8040 (Arm 2 Recipients Only)|-Death that results from a transplant procedure related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause|Up to 1 year after transplantation|-Donors are not evaluable for this outcome measure.|||proportion of participants||95% Confidence Interval|Number
2562249|NCT02639559|Secondary|Incidence of CMV Reactivation After Transplantation of Hematopoietic Cells Mobilized With BL-8040 in CMV Seropositive Recipients|-CMV reactivation will be defined as a positive test for CMV viremia as determined by an antigenemia assay or quantitative PCR that results in the administration of antiviral treatment directed against CMV|Up to 1 year after transplantation|-Donors are not evaluable for this outcome measure.|||Participants|||Count of Participants
2562250|NCT02639559|Secondary|Number of Participants Who Collect 5 x 106 CD34+ Cells/kg of Recipient Weight in a Single Leukapheresis and in 2 Leukapheresis Sessions (Arm 1 Donors Only)||Up to Day 2|-Recipients are not evaluable for this outcome measure. -Only donors who received 1.25 mg/kg of BL-8040 were evaluable for this outcome measure (the 1st 10 donors received 1.00 mg/kg of BL-8040)|||Participants|||Count of Participants
2562251|NCT02639559|Secondary|Cumulative Incidence of Chronic GvHD in Patients Who Have Undergone Transplantation of Hematopoietic Cells Mobilized With BL-8040 (Arm 2 Recipients Only)|"Chronic GVHD rate and severity for the first 365 days after PBSC infusion will be assessed based on the NIH criteria~The cumulative incidence of chronic GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death, relapse, and graft failure."|From Day 100 through 1 year after transplantation|-Donors are not evaluable for this outcome measure.|||proportion of participants||95% Confidence Interval|Number
2562252|NCT02639559|Secondary|Cumulative Incidence of Grade 2-4 Acute Graft Versus Host Disease (GvHD) as Measured by Minnesota Acute GVHD Criteria (Arm 2 Recipients Only)|"Acute GVHD rate and worst severity is noted~4 organ categories (skin, liver, lower GI, and upper GI)~Skin: Grade I: 1-2 , Grade II: 3, Grade III: N/A, Grade IV: 4~Liver: Grade I: 0, Grade II: 1, Grade III: 2-4, Grade IV: N/A~Lower GI: Grade I: 0, Grade II: 1: Grade II: 2-3: Grade IV: 4~Upper GI: Grade I: 0, Grade II: 1, Grade III: N/A, Grade IV: N/A~The cumulative incidence of grade 2-4 acute GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death, relapse, and graft failure."|Day 100|-Donors are not evaluable for this outcome measure.|||proportion of participants||95% Confidence Interval|Number
2562253|NCT02639559|Secondary|Incidence of Secondary Graft Failure After Transplantation of Hematopoietic Cells Mobilized With BL-8040 (Arm 2 Recipients Only)||Up to 1 year after transplantation|-Donors are not evaluable for this outcome measure.|||Participants|||Count of Participants
2562255|NCT02639559|Secondary|Time to Platelet Engraftment Post-transplant in Patients Undergoing Allogeneic Stem Cell Transplant (Arm 2 Recipients Only)|-Time to platelet engraftment is measured by determining the first of 3 consecutive measurements of platelet count ≥ 20,000/μL without platelet transfusion support for 7 days.|Through 90 days|-Donors are not evaluable for this outcome measure. 1 recipient was not evaluable due to now platelet nadir and 1 recipient was not evaluable due to no engraftment.|||days||Full Range|Median
2562256|NCT02639559|Secondary|Time to Neutrophil Engraftment Post-transplant in Patients Undergoing Allogeneic Stem Cell Transplant (Arm 2 Recipients Only)|-Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/μL following conditioning regimen induced nadir.|Up to Day 28|-Donors are not evaluable for this outcome measure.|||days||Full Range|Median
2562257|NCT02639559|Secondary|Safety and Tolerability of BL-8040 in Healthy Donors as Measured by Number and Grade of Adverse Events (Arm 1 Donors Only)|-Adverse events will be graded according to the NCI CTCAE version 4.03|Up to 5 years||2024-04-30|04/2024||||
2562258|NCT02639559|Primary|Number of Donors That Mobilize ≥ 2 x 10^6 CD34+ Cells/kg of Recipients Weight After a Single Injection of BL-8040 After no More Than Two Leukapheresis Collections (Arm 1 - Donors Only)||Up to Day 2|This outcome measure is for Arm 1 - Donors only.|||Participants|||Count of Participants
2562259|NCT02639494|Other Pre-specified|Number of Device Deficiencies Including But Not Limited to Failures, Malfunctions, Use Errors, Product Nonconformities, and Labeling Errors|All device deficiencies including but not limited to failures, malfunctions, use errors, product nonconformities, and labeling errors will be recorded in the case report form|72 hours post-procedure||||Device|Device||Count of Units
2562260|NCT02639494|Other Pre-specified|Any Adverse Event Occurring While the Self-Centering Guide Catheter is in the Subject||72 hours post-procedure||||Participants|||Count of Participants
2562261|NCT02639494|Other Pre-specified|Any Device-related Adverse Event||72 hours post-procedure||||Participants|||Count of Participants
2562262|NCT02639494|Other Pre-specified|Death, All-cause, Cardiovascular, and Non-cardiovascular||72 hours post-procedure||||Participants|||Count of Participants
2562263|NCT02639494|Other Pre-specified|Number of Participants With Cardiac Tamponade||72 hours post-procedure||||Participants|||Count of Participants
2562264|NCT02639494|Other Pre-specified|Number of Participants With Stroke||72 hours post-procedure||||Participants|||Count of Participants
2562265|NCT02639494|Other Pre-specified|Number of Self-Centering Guide Catheters With Device Success|Device success is defined as successful delivery of a guide wire through the Self-Centering Guide Catheter across the stenotic native aortic valve into the left ventricle and successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system. This outcome will be assessed via physician determination and will be recorded in the case report form.|Through study completion, up to 72 hours post-procedure||||Device|Device||Count of Units
2562266|NCT02639494|Other Pre-specified|Successful Recapture of the Distal Self-centering Basket of the Device Into the Guide and Withdrawal of the Self-Centering Guide Catheter Through the Guide System|The outcome measure of successful recapture of the distal self-centering basket of the device into the guide and withdrawal of the Self-Centering Guide Catheter through the guide system will be assessed via physician assessment of the self-centering basket recapture and will be recorded in the case report form.|Through study completion, up to 72 hours post-procedure||||Device|Device||Count of Units
2562267|NCT02639494|Other Pre-specified|Number of Attempts Made to Cross the Stenotic Native Aortic Valve With a PTFE-coated Guidewire||Through study completion, up to 72 hours post-procedure||||Attempts|Device|95% Confidence Interval|Mean
2562268|NCT02639494|Other Pre-specified|Time From Insertion of the Self-Centering Guide Catheter Into the Body to Removal of the Self-Centering Guide Catheter From the Body||Through study completion, up to 72 hours post-procedure|A guide wire was delivered through the self-centering guide catheter in 18/20 patients. In total 23 devices were used.|||minutes|Devices|95% Confidence Interval|Mean
2562269|NCT02639494|Other Pre-specified|Time From Insertion of the Self-Centering Guide Catheter Into the Body to Successful Placement of a PTFE-coated Guidewire Across the Stenotic Native Aortic Valve||Through study completion, up to 72 hours post-procedure|A guide wire was delivered through the self-centering guide catheter in 18/20 patients.|||minutes||95% Confidence Interval|Mean
2562270|NCT02639494|Primary|Number of Self-Centering Guide Catheters Successfully Used to Deliver a Guide Wire Through the Self-Centering Guide Catheter Across the Stenotic Native Aortic Valve Into the Left Ventricle|This outcome will be assessed via physician determination and will be recorded in the case report form.|Through study completion, up to 72 hours post-procedure|20 patients were treated with 23 devies|||Device|Device||Count of Units
2562271|NCT02639429|Secondary|Composite Neonatal Morbidity as Indicated by the Number of Newborns With Measures of Neonatal Morbidity|"Measures of neonatal morbidity assessed:~Apgar score ≤ 7 at 5 mins~Umbilical cord potential of hydrogen (pH) < 7.1~Neonatal injury: brachial plexus injury, fracture~Perinatal death"|From delivery to neonatal discharge (approximately 2 to 7 days)||||Participants|||Count of Participants
2562272|NCT02639429|Secondary|Number of Newborns With Seizures||From delivery to neonatal discharge (approximately 2 to 7 days)||||Participants|||Count of Participants
2562273|NCT02639429|Secondary|Number of Newborns With Culture-proven Sepsis||From delivery to neonatal discharge (approximately 2 to 7 days)||||Participants|||Count of Participants
2562274|NCT02639429|Secondary|Number of Newborns With Meconium Aspiration Syndrome||From delivery to neonatal discharge (approximately 2 to 7 days)|Data was not collected for this outcome measure.||||||
2562275|NCT02639429|Secondary|Number of Newborns With Respiratory Distress Syndrome (RDS)||From delivery to neonatal discharge (approximately 2 to 7 days)||||Participants|||Count of Participants
2562276|NCT02639429|Secondary|Number of Newborns With Transient Tachypnea (TTN)||From delivery to neonatal discharge (approximately 2 to 7 days)||||Participants|||Count of Participants
2562277|NCT02639429|Secondary|Number of Newborns Admitted to the Neonatal Intensive Care Unit (NICU)||From delivery to neonatal discharge (approximately 2 to 7 days)||||Participants|||Count of Participants
2562474|NCT02638259|Secondary|Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24||baseline, Week 4, week 12, week 24|Treatment period 1 per protocol set. Patients with data available|||score on a scale||Standard Deviation|Mean
2562278|NCT02639429|Secondary|Composite Maternal Morbidity as Indicated by the Number of Participants With Measures of Maternal Morbidity|"Measures of maternal morbidity assessed:~Maternal ICU admission~Postpartum endometritis~Surgical-site infections prior to discharge~Venous thromboembolism~Need for transfusion~Maternal death"|Induction to discharge (approximately 5 days)||||Participants|||Count of Participants
2562279|NCT02639429|Secondary|Number of Participants With a Need for Operative Vaginal Delivery||Induction to delivery||||Participants|||Count of Participants
2562280|NCT02639429|Secondary|Number of Participants With Clinical Chorioamnionitis|Clinical chorioamnionitis is indicated by maternal fever ≥ 100.4 Fahrenheit, uterine fundal tenderness, maternal or fetal tachycardia (>100/min and >160/min, respectively), and purulent or foul amniotic fluid.|Induction to delivery||||Participants|||Count of Participants
2562281|NCT02639429|Secondary|Number of Participants Exhibiting Tachysystole Resulting in Fetal Heart Rate Abnormalities|Uterine tachysystole is a condition of excessively frequent uterine contractions during pregnancy. Tachysystole is indicated ≥ 5 contractions in a 10 minute period averaged over a 30-minute window.|Induction to delivery||||Participants|||Count of Participants
2562282|NCT02639429|Secondary|Number of Participants With a Need for Oxytocin Augmentation||Induction to delivery||||Participants|||Count of Participants
2562283|NCT02639429|Secondary|Induction-to-delivery Interval in Hours||Induction to delivery||||hours||Standard Deviation|Mean
2562284|NCT02639429|Secondary|Indication for Cesarean Delivery|"Categories of Indications for Cesarean Delivery:~= Cephalopelvic disproportion~= Failed induction/Failure to progress~= Cord prolapse~= Non-reassuring fetal tracing~= Malpresentation~= Placental abruption~= Other"|Induction to delivery|Only 51 in the Combined arm and 53 in the single arm delivered by cesarean.|||Participants|||Count of Participants
2562285|NCT02639429|Primary|Number of Participants With a Need for Cesarean Delivery||Induction to delivery||||Participants|||Count of Participants
2562286|NCT02639351|Secondary|Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA|The percentage of subjects with at least a 4-fold increase in antibody concentrations to MenC serogroup as measured by ELISA were analysed at day 8, 29 and 181 relative to Day 1 (pre-dose).|At Day 8, Day 29 and Day 181|Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unblinding or analysis.|||Percentage of subjects||95% Confidence Interval|Number
2562287|NCT02639351|Secondary|Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA)|The antibody concentrations were assessed by ELISA and expressed as Geometric Mean Concentrations (GMCs) in microgram per mililiter (μg/mL).|At Day 1 (pre-dose), Day 8, Day 29 and Day 181|Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unblinding or analysis.|||μg/mL||95% Confidence Interval|Geometric Mean
2562288|NCT02639351|Secondary|Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC).|The percentage of subjects who achieved hSBA seroresponse against MenC serogroup was evaluated at Day 8, Day 29 and Day 181 after vaccination. Seroresponse was defined as a post vaccination hSBA ≥ 8 for subjects with a baseline hSBA lower than (<) 4 or had an increase of at least 4 times the baseline hSBA level for subjects with pre vaccination hSBA ≥ 4.|At Day 8, Day 29 and Day 181|Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unblinding or analysis.|||Percentage of subjects||95% Confidence Interval|Number
2562289|NCT02639351|Secondary|GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup|GMR of GMTs of antibodies against MenC serogroup was evaluated at Day 8 and Day 181 relative to Day 1 (pre-dose).|At Day 8 and Day 181|Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unblinding or analysis.|||Ratio||95% Confidence Interval|Geometric Mean
2562290|NCT02639351|Secondary|hSBA GMTs Against N. Meningitidis Serogroup C (MenC)|The antibody concentrations were assessed by hSBA directed against MenC and expressed as GMTs.|At Day 8 and Day 181|Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unblinding or analysis.|||Titer||95% Confidence Interval|Geometric Mean
2562291|NCT02639351|Primary|Geometric Mean Ratio (GMR) of the Titers of Antibodies Measured by hSBA Against MenC Serogroup|GMR of GMTs of antibodies against MenC was evaluated at Day 29 relative to Day 1 (pre-dose).|At Day 29|Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unblinding or analysis.|||Ratio||95% Confidence Interval|Geometric Mean
2562292|NCT02639351|Primary|hSBA GMTs Against N. Meningitidis Serogroup C (MenC)|The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs.|At Day 29|Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unbliding or analysis.|||Titer||95% Confidence Interval|Geometric Mean
2562293|NCT02639351|Primary|Human Complement Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup C (MenC)|The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs.|At Day 1 (pre-dose)|Analysis was performed on the Per Protocol Set (PPS) which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unbliding or analysis.|||Titer||95% Confidence Interval|Geometric Mean
2562294|NCT02639351|Primary|Number of Subjects With Abnormal Laboratory Parameter Values|"The abnormal laboratory parameters values were defined following the FDA CBER Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials dated September 2007, or the institution's normal ranges if they differ from CBER guidance"|At Day 29|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Participants|||Count of Participants
2562295|NCT02639351|Primary|Number of Subjects With Abnormal Laboratory Parameter Values|"The abnormal laboratory parameters values were defined following the FDA CBER Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials dated September 2007, or the institution's normal ranges if they differ from CBER guidance"|At Day 8|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Participants|||Count of Participants
2562296|NCT02639351|Primary|Number of Subjects With Abnormal Laboratory Parameter Values|"The abnormal laboratory parameters values were defined following the FDA CBER Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials dated September 2007, or the institution's normal ranges if they differ from CBER guidance"|At Day 1 (post-dose)|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Participants|||Count of Participants
2562297|NCT02639351|Primary|Number of Subjects With Abnormal Laboratory Parameter Values|The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.|At Day 29|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Participants|||Count of Participants
2562298|NCT02639351|Primary|Number of Subjects With Abnormal Laboratory Parameter Values|The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.|At Day 8|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Participants|||Count of Participants
2562299|NCT02639351|Primary|Number of Subjects With Abnormal Laboratory Parameter Values|The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.|At Day 1 (post-dose)|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Participants|||Count of Participants
2562300|NCT02639351|Primary|Changes in Urinalysis Parameters|Analysis was performed on urine samples collected at day 29 (post-dose) for the following parameter: urine protein in g/L. The change was calculated as difference between the day 1 (pre-dose) results and the day 29 (post-dose) results.|At Day 29|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of g/L||Standard Deviation|Mean
2562301|NCT02639351|Primary|Changes in Urinalysis Parameters|Analysis was performed on urine samples collected at day 8 (post-dose) for the following parameter: urine protein in g/L. The change was calculated as difference between the day 1 (pre-dose) results and the day 8 (post-dose) results.|At Day 8|Analysis was performed on the safety set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of g/L||Standard Deviation|Mean
2562302|NCT02639351|Primary|Changes in Urinalysis Parameters|Analysis was performed on urine samples collected at day 1 (post-dose) for the following parameter: urine protein in g/L. The change was calculated as difference between the day 1 (pre-dose) results and the day 1 (post-dose) results.|At Day 1 (post-dose)|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of g/L||Standard Deviation|Mean
2562303|NCT02639351|Primary|Absolute Values for Urinalysis Parameters- Urine Protein|The absolute value for urinalysis was assessed for the following parameter: urine protein in g/L|At Day 1 (pre-dose)|Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had either post-vaccination AE or reactogenicity records.|||g/L||Standard Deviation|Mean
2562304|NCT02639351|Primary|Changes in Urinalysis Parameters|Analysis was performed on urine samples collected at Day 29 (post-dose) for the following parameter: Urine glucose in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 (post-dose) results.|At Day 29|Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had either post-vaccination AE or reactogenicity records.|||Difference of mmol/L||Standard Deviation|Mean
2562305|NCT02639351|Primary|Changes in Urinalysis Parameters|Analysis was performed on urine samples collected at Day 8 (post-dose) for the following parameter: urine glucose in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 (post-dose) results.|At Day 8|Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had either post-vaccination AE or reactogenicity records.|||Difference of mmol/L||Standard Deviation|Mean
2562306|NCT02639351|Primary|Changes in Urinalysis Parameters|Analysis was performed on urine samples collected at Day 1 (post-dose) for the following parameter: urine glucose in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.|At Day 1 (post-dose)|Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had either post-vaccination AE or reactogenicity records.|||Difference of mmol/L||Standard Deviation|Mean
2562307|NCT02639351|Primary|Absolute Values for Urinalysis Parameters- Urine Glucose|The absolute value for urinalysis was assessed for the following parameter: urine glucose in mmol/L.|At Day 1 (pre-dose)|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||mmol/L||Standard Deviation|Mean
2562308|NCT02639351|Primary|Changes in Urinalysis Parameters|Analysis was performed on urine samples collected at Day 29 for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.|At Day 29|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of μL||Standard Deviation|Mean
2562309|NCT02639351|Primary|Changes in Urinalysis Parameters|Analysis was performed on urine samples collected at Day 8 for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.|At Day 8|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of μL||Standard Deviation|Mean
2562310|NCT02639351|Primary|Changes in Urinalysis Parameters|Analysis was performed on urine samples collected at Day 1 (post-dose) for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.|At Day 1 (post-dose)|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of μL||Standard Deviation|Mean
2562311|NCT02639351|Primary|Absolute Values for Urinalysis Parameters- Urine Erythrocytes (Urine RBC)|Analysis was performed on urine samples collected at Day 1 (pre-dose) for the following parameter: Urine RBC in microliters (μL).|At Day 1 (pre-dose)|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||μL||Standard Deviation|Mean
2562312|NCT02639351|Primary|Changes in Hematology Parameters|Analysis was performed on blood samples collected at Day 29 for the following parameter: HGB in g/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.|At Day 29|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of g/L||Standard Deviation|Mean
2562313|NCT02639351|Primary|Changes in Hematology Parameters|Analysis was performed on blood samples collected at Day 8 for the following parameter: HGB in g/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.|At Day 8|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of g/L||Standard Deviation|Mean
2562314|NCT02639351|Primary|Changes in Hematology Parameters|Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: HGB in g/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.|At Day 1 (post-dose)|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of g/L||Standard Deviation|Mean
2562315|NCT02639351|Primary|Absolute Values for Hematology Parameters- Hemoglobin (HGB)|Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: HGB in gram per liter (g/L).|At Day 1 (pre-dose)|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||g/L||Standard Deviation|Mean
2562316|NCT02639351|Primary|Changes in Hematology Parameters|Analysis was performed on blood samples collected at Day 29 for the following parameter: hematocrit in L/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.|At Day 29|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of L/L||Standard Deviation|Mean
2562317|NCT02639351|Primary|Changes in Hematology Parameters|Analysis was performed on blood samples collected at Day 8 for the following parameter: hematocrit in L/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.|At Day 8|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of L/L||Standard Deviation|Mean
2562318|NCT02639351|Primary|Changes in Hematology Parameters|Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: hematocrit in L/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.|At Day 1 (post-dose)|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of L/L||Standard Deviation|Mean
2562319|NCT02639351|Primary|Absolute Values for Hematology Parameters- Hematocrit|Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: hematocrit in liter per liter (L/L).|At Day 1 (pre-dose)|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||L/L||Standard Deviation|Mean
2562320|NCT02639351|Primary|Changes in Hematology Parameters|Analysis was performed on blood samples collected at Day 29 for the following parameter: RBC in 10^12/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.|At Day 29|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of 10^12/L||Standard Deviation|Mean
2562321|NCT02639351|Primary|Changes in Hematology Parameters|Analysis was performed on blood samples collected at Day 8 for the following parameter: RBC in 10^12/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.|At Day 8|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of 10^12/L||Standard Deviation|Mean
2562322|NCT02639351|Primary|Changes in Hematology Parameters|Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: RBC in 10^12/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.|At Day 1 (post-dose)|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of 10^12/L||Standard Deviation|Mean
2562323|NCT02639351|Primary|Absolute Values for Hematology Parameters- Red Blood Cells (RBC)|Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: RBC in 10^12 cells per liter (10^12/L).|At Day 1 (pre-dose)|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||10^12/L||Standard Deviation|Mean
2562357|NCT02639338|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2562324|NCT02639351|Primary|Changes in Hematology Parameters|Analysis was performed on blood samples collected at Day 29 for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.|At Day 29|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of 10^9/L||Standard Deviation|Mean
2562325|NCT02639351|Primary|Changes in Hematology Parameters|Analysis was performed on blood samples collected at Day 8 for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.|At Day 8|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of 10^9/L||Standard Deviation|Mean
2562326|NCT02639351|Primary|Changes in Hematology Parameters|Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.|At Day 1 (post-dose)|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of 10^9/L||Standard Deviation|Mean
2562327|NCT02639351|Primary|Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes.|Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9 cells per liter (10^9/L)|At Day 1 (pre-dose)|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||10^9/L||Standard Deviation|Mean
2562328|NCT02639351|Primary|Changes in Clinical Serum Chemistry Parameters|Analysis was performed on blood samples collected at Day 29 for the following parameter: CRP in mg/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.|At Day 29|Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of mg/L||Standard Deviation|Mean
2562329|NCT02639351|Primary|Changes in Clinical Serum Chemistry Parameters|Analysis was performed on blood samples collected at Day 8 for the following parameter: CRP in mg/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.|At Day 8|Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of mg/L||Standard Deviation|Mean
2562330|NCT02639351|Primary|Changes in Clinical Serum Chemistry Parameters|Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: CRP in mg/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.|At Day 1 (post-dose)|Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of mg/L||Standard Deviation|Mean
2562331|NCT02639351|Primary|Absolute Values for Clinical Serum Chemistry Parameters- C-reactive Protein (CRP)|Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: CRP in milligram per liter (mg/L).|At Day 1 (pre-dose)|Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||mg/L||Standard Deviation|Mean
2562332|NCT02639351|Primary|Changes in Clinical Serum Chemistry Parameters|Analysis was performed on blood samples collected at Day 29 for the following parameters: ALT and AST in IU/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.|At Day 29|Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of IU/L||Standard Deviation|Mean
2562333|NCT02639351|Primary|Changes in Clinical Serum Chemistry Parameters|Analysis was performed on blood samples collected at Day 8 for the following parameters: ALT and AST in IU/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.|At Day 8|Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of IU/L||Standard Deviation|Mean
2562334|NCT02639351|Primary|Changes in Clinical Serum Chemistry Parameters|Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: ALT and AST in IU/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.|At Day 1 (post-dose)|Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of IU/L||Standard Deviation|Mean
2562335|NCT02639351|Primary|Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)|Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: ALT and AST in International Units per liter (IU/L).|At Day 1 (pre-dose)|Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||IU/L||Standard Deviation|Mean
2562336|NCT02639351|Primary|Changes in Clinical Serum Chemistry Parameters|Analysis was performed on blood samples collected at Day 29 for the following parameter: CREA in μmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.|At Day 29|Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of μmol/L||Standard Deviation|Mean
2562337|NCT02639351|Primary|Changes in Clinical Serum Chemistry Parameters|Analysis was performed on blood samples collected at Day 8 for the following parameter: CREA in μmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.|At Day 8|Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of μmol/L||Standard Deviation|Mean
2562358|NCT02639338|Primary|Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
2562338|NCT02639351|Primary|Changes in Clinical Serum Chemistry Parameters|Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: CREA in μmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.|At Day 1 (post-dose)|Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of μmol/L||Standard Deviation|Mean
2562339|NCT02639351|Primary|Absolute Values for Clinical Serum Chemistry Parameters-Creatinine|Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: Creatinine (CREA) in micro mole per liter (μmol/L)|At Day 1 (pre-dose)|Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||μmol/L||Standard Deviation|Mean
2562340|NCT02639351|Primary|Changes in Clinical Serum Chemistry Parameters|Analysis was performed on blood samples collected at Day 29 for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.|At Day 29|Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of mmol/L||Standard Deviation|Mean
2562341|NCT02639351|Primary|Changes in Clinical Serum Chemistry Parameters|Analysis was performed on blood samples collected at Day 8 for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.|At Day 8|Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data.|||Difference of mmol/L||Standard Deviation|Mean
2562342|NCT02639351|Primary|Changes in Clinical Serum Chemistry Parameters|Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.|At Day 1 (post-dose)|Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||Difference of mmol/L||Standard Deviation|Mean
2562343|NCT02639351|Primary|Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate.|Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: Na, K, Cl, BUN and bicarbonate in millimoles per liter (mmol/L).|At Day 1 (pre-dose)|Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data|||mmol/L||Standard Deviation|Mean
2562344|NCT02639351|Primary|Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs.|SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly or in an important and significant medical event that could jeopardize the subject or could requiered intervention to prevent one of the other outcomes mentioned above. MAAEs were defined as an AE that lead to a visit to a healthcare provider. NOCDs were defined as AEs leading to study or vaccine withdrawal. AESIs were defined according to MedDRA preferred terms.Certain AEs of special interest (AESIs) are monitored after the administration of immunostimulatory agents. These are pre-defined and include AEs in the SOCs of Gastroin-testinal disorders, Liver disorders, Metabolic diseases, Musculo-skeletal disorders, Neuroinflammatory disorders, Skin disorders, Vasculitides and others|From Day 29 up to study end (Day 366)|Analysis was performed on the Unsolicited Safety Set which included all enrolled subjects who received a study vaccination and had post-vaccination unsolicited adverse events data.|||Participants|||Count of Participants
2562345|NCT02639351|Primary|Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs.|SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly or in an important and significant medical event that could jeopardize the subject or could requiered intervention to prevent one of the other outcomes mentioned above. MAAEs were defined as an AE that lead to a visit to a healthcare provider. NOCDs were defined as AEs leading to study or vaccine withdrawal. AESIs were defined according to MedDRA preferred terms.Certain AEs of special interest (AESIs) are monitored after the administration of immunostimulatory agents. These are pre-defined and include AEs in the SOCs of Gastrointestinal disorders, Liver disorders, Metabolic diseases, Musculo-skeletal disorders, Neuroinflammatory disorders, Skin disorders, Vasculitides and others|From Day 1 to Day 29|Analysis was performed on the Unsolicited Safety Set which included all enrolled subjects who received a study vaccination and had post-vaccination unsolicited adverse event data.|||Participants|||Count of Participants
2562346|NCT02639351|Primary|Number of Subjects With Any Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Study Withdrawal, New Onset of Chronic Disease (NOCDs) and Adverse Events of Special Interest (AESIs).|SAEs are untoward medical occurrences that at any dose resulted in death,was life-threatening,required/prolonged hospitalization,persistent/significant disability/incapacity,congenital anomaly/in important & significant medical event that could jeopardize the subject/could required intervention to prevent one of the other outcomes mentioned above.MAAEs are AEs that lead to a visit to a healthcare provider.NOCDs are adverse events that represent new diagnosis of a chronic medical condition that was not present/suspected in a subject prior to study enrolment.AESIs were defined according to MedDRA preferred terms.Certain AESIs are monitored after administration of immunostimulatory agents.These are pre-defined & include AEs in the SOCs of Gastrointestinal disorders,Liver disorders,Metabolic diseases,Musculo-skeletal disorders,Neuroinflammatory disorders,Skin disorders,Vasculitides & others.|From Day 1 to Day 366|Analysis was performed on the Unsolicited Safety Set which included all enrolled subjects who received a study vaccination and had post-vaccination unsolicited adverse events data. Data for this endpoint was analyzed from Day 1 to study termination (Day 366). Data from day of signed informed consent till Day 1(as per protocol) were not collected.|||Participants|||Count of Participants
2562359|NCT02639338|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: all randomized/enrolled participants who took at least 1 dose of the study drug|||percentage of participants||95% Confidence Interval|Number
2562347|NCT02639351|Primary|Number of Subjects With Any Unsolicited AEs|An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. This definition includes intercurrent illnesses or injuries and exacerbation of pre-existing conditions. Unsolicited adverse event were defined as symptoms that were not solicited using a Subject Diary and that were spontaneously communicated by a subject who has signed the informed consent. Unsolicited AEs were collected through the Day 29 visit and the analysis was performed for Day 1-29 time frame, instead of Day 1-14 as required by protocol.|From Day 1 to Day 29|Analysis was performed on the Unsolicited Safety Set which included all enrolled subjects who received a study vaccination and provided post-vaccination unsolicited adverse event data.|||Participants|||Count of Participants
2562348|NCT02639351|Primary|Number of Subjects With Any Solicited Local and Systemic AEs|Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.|From Day 1 to Day 14 (excluding 30 minutes immediately after any vaccination)|Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and provided post-vaccination solicited local and systemic symptoms data|||Participants|||Count of Participants
2562349|NCT02639351|Primary|Number of Subjects With Any Solicited Local and Systemic AEs|Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.|From Day 1 to Day 8 (excluding 30 minutes immediately after vaccination)|Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported solicited local and systemic symptoms|||Participants|||Count of Participants
2562350|NCT02639351|Primary|Number of Subjects With Any Solicited Local and Systemic AEs|Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.|From Day 8 to Day 14|Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported solicited local and systemic symptoms|||Participants|||Count of Participants
2562351|NCT02639351|Primary|Number of Subjects With Any Solicited Local and Systemic AEs|Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade.|From Day 5 to Day 8|Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported solicited local and systemic symptoms|||Participants|||Count of Participants
2562352|NCT02639351|Primary|Number of Subjects With Any Solicited Local and Systemic AEs|Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.|From Day 1 to Day 4 (excluding 30 minutes immediately after vaccination)|Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported local and systemic symptoms|||Participants|||Count of Participants
2562353|NCT02639351|Primary|Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs)|Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature greater than or equal to (≥) 38 degrees Celsius (°C), as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade.|Within 30 minutes of vaccination (Min) at Day 1|Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported solicited local and systemic symptoms.|||Participants|||Count of Participants
2562354|NCT02639338|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2562360|NCT02639247|Secondary|Percentage of Participants With Virologic Failure|"On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2562361|NCT02639247|Secondary|Change From Baseline in HCV RNA||Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2562362|NCT02639247|Secondary|Percentage of Participants With HCV RNA < LLOQ On Treatment||Weeks 1, 2, 4, 8 and 12|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2562363|NCT02639247|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participcants||95% Confidence Interval|Number
2562364|NCT02639247|Primary|Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
2562365|NCT02639247|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: all randomized or enrolled participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2562366|NCT02639052|Secondary|Change in Heat Pain Relief by VAS Pain Intensity Reporting After 1 Week, 1 Month, and 3 Months After Treatment|A secondary endpoint is to see if Botox has a relieving effect on heat pain using a pain visual analog scale (VAS) intensity scale as an outcome measure. The pain VAS intensity scale ranges from a minimum of 0 (no pain - best) to a maximum of 10 (maximum pain - worst). Participants will rate pain intensity after pain is induced with a heat thermode.|Baseline, 1 week, 1 month, 3 months||||units on a scale||Standard Deviation|Mean
2562367|NCT02639052|Primary|Itch by VAS Itch Intensity at 3 Months (Visit 4)|The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.|3 Months from Baseline||||units on a scale||Standard Deviation|Mean
2562368|NCT02639052|Primary|Itch by VAS Itch Intensity at 1 Month (Visit 3)|The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.|1 Month from Baseline||||units on a scale||Standard Deviation|Mean
2562369|NCT02639052|Primary|Itch by VAS Itch Intensity at 1 Week (Visit 2)|The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.|1 week from Baseline||||units on a scale||Standard Deviation|Mean
2562370|NCT02639052|Primary|Itch by VAS Itch Intensity at Baseline (Visit 1)|The primary endpoint is to test the antipruritic effect of Botox using an itch visual analog scale (VAS) intensity scale as an outcome measure. The itch VAS intensity scale ranges from a minimum of 0 (no itch - best) to a maximum of 10 (maximum itch - worst). Participants will rate itch intensity after itch is induced with cowhage.|Baseline (Visit 1)||||units on a scale||Standard Deviation|Mean
2562371|NCT02638974|Secondary|Adapted-DQLI|Adapted-DQLI Minimum: 0 Maximum: 24 The higher the score on the Dermatology Quality of Life Index the more impaired the quality of life|6 weeks||||score on a scale||Standard Deviation|Mean
2562372|NCT02638974|Secondary|Rosenberg Self-Esteem Scale|RSE Minimum: 0 Maximum: 30 Higher scores represent higher self-esteem|6 weeks||||score on a scale||Standard Deviation|Mean
2562373|NCT02638974|Secondary|Becks Hopelessness Scale|BHS, Minimum: 0 Maximum: 20. 0-3 indicates No or minimal hopelessness; 4-8 is mild; 9-14 is moderate and 15+ is severe|6 weeks||||score on a scale||Standard Deviation|Mean
2562374|NCT02638974|Secondary|Becks Depression Inventory|BDI-II Minimum: 0 Maximum: 63. 0-13 indicates minimal depression; 14-19 mild depression; 20-28 moderate depression and 29-63 severe depression|6 weeks||||score on a scale||Standard Deviation|Mean
2562375|NCT02638974|Secondary|Becks Scale for Suicidal Ideation|BSS MInimum: 0 Maximum: 28. The higher the score the greater the suicidal ideation.|6 weeks||||score on a scale||Standard Deviation|Mean
2562376|NCT02638974|Primary|Warwick-Edinburgh Mental Well-being Scale|WEMWBS, Minimum: 14 Maximum: 70. Higher scores represent higher mental wellbeing|6 weeks||||score on a scale||Standard Deviation|Mean
2562377|NCT02638948|Secondary|Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Cartilage Loss at Week 4 and 12|Cartilage loss was assessed by MRI. Scans of 25 joints were read and scored for each participant by assessors. Scores for each location ranged 0-4 on a 9-point scale, with 0= no cartilage loss and 4= complete cartilage loss. Total score was the sum of the 25 individual scores and ranged 0-100 with 0= no cartilage loss and 100= most severe cartilage loss. A negative change from baseline indicates improvement.|Week 4, and Week12|Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here number analyzed = number of randomized and treated participants with non-missing value at each time point|||Scores on a scale||Standard Error|Mean
2562405|NCT02638493|Primary|Semen Clearance (CL) of Emtricitabine|Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate clearance from semen from a 200mg dose of emtricitabine.|Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose||||L/hr||Inter-Quartile Range|Median
2562406|NCT02638493|Primary|Semen Clearance (CL) of Tenofovir|Samples will be analyzed for drug concentrations at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate clearance from semen from a 300mg dose of tenofovir.|Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose||||L/hr||Inter-Quartile Range|Median
2562378|NCT02638948|Secondary|Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Bone Erosion at Week 4 and 12|Bone erosion assessed at a total of 23 anatomic locations: 15 in 1 wrist and 8 in the hand of the same side. Each site is scored in 1.0 increments from 0 (no damage) to 10 (severe damage) according to erosion of the original articular bone (each unit=10% loss of articular bone). The total erosion score for the hands/wrists is the sum of the individual scores for each location. Thus the maximum score achievable per hand/wrist is 230. Increasing score=greater severity.A negative change from baseline indicates improvement.|Week 4 and Week 12|Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here number analyzed = number of randomized and treated participants with non-missing value at each time point|||Scores on a scale||Standard Error|Mean
2562379|NCT02638948|Secondary|Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Osteitis at Week 4 and 12|Osteitis was assessed at a total of 23 anatomic locations: 15 in 1 wrist and 8 in the hand of the same side. Each site is scored in 1.0 increments from 0 to 3, indicating involvement of original articular bone. The total score for the hands/wrists is the sum of the individual scores for each location. Thus the maximum score achievable per hand/wrist is 23 (total number of anatomic locations) * 3 (maximum per joint)=69. Minimum score=0, indicating normal. Increasing score=greater severity. A negative change from baseline indicates improvement.|Week 4, and Week 12|Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here number analyzed = number of randomized and treated participants with non-missing value at each time point|||Scores on a scale||Standard Error|Mean
2562380|NCT02638948|Secondary|Mean Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scores for Synovitis at Week 4 and 12|Synovitis is assessed in 3 wrist regions (A. the distal radioulnar joint; B. the radiocarpal joint; C. the intercarpal and carpometacarpophalangeal, CMC, joints) and in each MCP joint. For each wrist region, possible score ranges from 0-3, with 0=normal, 1=mild, 2=moderate, and 3=severe damage. The total synovitis score per wrist=the sum of the individual scores for the 3 wrist regions. Minimum score per wrist ranges from 0, indicating no damage, to 9 (score of 3*3 wrist regions), indicating most severe damage. A negative change from baseline indicates improvement.|Week 4 and Week 12|Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here number analyzed = number of randomized and treated participants with non-missing value at each time point|||Scores on a scale||Standard Error|Mean
2562381|NCT02638948|Secondary|Trough Observed Plasma Concentration (Ctrough) of BMS-986142|Ctrough was defined as trough observed plasma concentration.|Week 4, 8, and 12|Analysis was performed on pharmacokinetic population which included all participants who received BMS-986142 and had any available concentration-time data.|||nanogram/mL||Geometric Coefficient of Variation|Geometric Mean
2562382|NCT02638948|Secondary|Number of Participants With Adverse Events (AEs), and Serious AEs (SAEs)|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event.|Up to 30 days after treatment discontinuation|All treated participants.|||Participants|||Count of Participants
2562383|NCT02638948|Secondary|Change From Baseline in SDAI Score Over Time up to Week 12|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on a VAS scale ranging from 0 to 10 cm, where higher scores indicate greater affection due to disease activity, and CRP measured in terms of mg/dL. SDAI total score ranges from 0 to 86. SDAI <= 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity.|Baseline, Week 12|Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here 'N' signifies number of participants analyzed who were evaluable for this outcome measure.|||Units on a scale||Standard Error|Mean
2562384|NCT02638948|Secondary|Change From Baseline in CDAI Score Over Time up to Week 12|CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: TJC (28 joints), SJC (28 joints), Participant's Global Assessment of Disease Activity VAS (in cm), and Physician's Global Assessment of Disease VAS (in cm). Total scores ranges from 0 to 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.|Baseline, Week 12|Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here 'N' signifies number of participants analyzed who were evaluable for this outcome measure.|||Units on a scale||Standard Error|Mean
2562385|NCT02638948|Secondary|Change From Baseline in DAS28-ESR Score Over Time up to Week 12|DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission.|Baseline, Week 12|Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here 'N' signifies number of participants analyzed who were evaluable for this outcome measure.|||Units on a scale||Standard Error|Mean
2562407|NCT02638337|Secondary|Change From Baseline in Free Testosterone at Week 12||Baseline and Week 12|Intent-to-treat population with available data|||nmol/L||Standard Deviation|Mean
2562408|NCT02638337|Secondary|Change From Baseline in Testosterone at Week 12||Baseline and Week 12|Intent-to-treat population with available data|||ng/dL||Standard Deviation|Mean
2562386|NCT02638948|Secondary|Change From Baseline in DAS28-CRP Score Over Time up to Week 12|DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS). Marker of inflammation assessed by the high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28 score provides a number indicating the current disease activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission.|Baseline, Day 85 (Week 12)|Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA). Here 'N' signifies number of participants analyzed who were evaluable for this outcome measure.|||Units on a scale||Standard Error|Mean
2562387|NCT02638948|Secondary|Percentage of Participants Achieving Boolean Remission Criteria at Week 12|Boolean remission criteria was defined as: tender joint count28 <= 1; swollen joint count28 <= 1; physician's global assessment <= 1; and CRP <= 1 mg/deciliter.|Week 12|Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA)|||Percentage of participants||95% Confidence Interval|Number
2562388|NCT02638948|Secondary|Percentage of Participants Achieving <= 3.3 Response in Simple Disease Activity Index (SDAI) Score at Week 12|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on a VAS scale ranging from 0 to 10 cm, where higher scores indicate greater affection due to disease activity, and CRP measured in terms of milligram per deciliter (mg/dL). SDAI total score ranges from 0 to 86. SDAI <= 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity.|Week 12|Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA)|||Percentage of participants||95% Confidence Interval|Number
2562389|NCT02638948|Secondary|Percentage of Participants Achieving <= 2.8 Response in Clinical Disease Activity Index (CDAI) Score at Week 12|CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: TJC (28 joints), SJC (28 joints), Participant's Global Assessment of Disease Activity VAS (in cm), and Physician's Global Assessment of Disease VAS (in cm). Total scores ranges from 0 to 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity.|Week 12|Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA)|||Percentage of participants||95% Confidence Interval|Number
2562390|NCT02638948|Secondary|Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints Erythrocyte Sedimentation Rate (DAS28--ESR) Score at Week 12|DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission.|Week 12|Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA)|||Percentage of participants||95% Confidence Interval|Number
2562391|NCT02638948|Secondary|Percentage of Participants Achieving < 2.6 Response in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 12|DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS). Marker of inflammation assessed by the high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28 score provides a number indicating the current disease activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission.|Week 12|Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA)|||Percentage of participants||95% Confidence Interval|Number
2562392|NCT02638948|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% Response Over Time From Baseline to Week 12|ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR70 is defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR70 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100|Baseline, Day 15, Day 29, Day 57, Day 85|Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA)|||Percentage of participants||95% Confidence Interval|Number
2562393|NCT02638948|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Over Time From Baseline to Week 12|ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR70 is defined as achieving at least 50% improvement in both TJC and SJC, and at least 50% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR50 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100|Baseline, Day 15, Day 29, Day 57, Day 85|Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA)|||Percentage of participants||95% Confidence Interval|Number
2562394|NCT02638948|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% Response Over Time From Baseline to Week 12|ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: tender joint count (TJC); swollen joint count (SJC); levels of an acute phase reactant C-reactive Protein levels (CRP); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by health assessment questionnaire disability index (HAQ-DI). ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR20 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100|Baseline, Day 15, Day 29, Day 57, Day 85|Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA)|||Percentage of participants||95% Confidence Interval|Number
2562395|NCT02638948|Primary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12|ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR70 is defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR70 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100|Week 12|Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA)|||Percentage of participants||95% Confidence Interval|Number
2562396|NCT02638948|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: tender joint count (TJC); swollen joint count (SJC); levels of an acute phase reactant C-reactive Protein levels (CRP); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by health assessment questionnaire disability index (HAQ-DI). ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR. Percentage of Participants achieving ACR20 = (number of participants with measure/event of interest)/(number of particpants in the analysis)*100|Week 12|Analysis was performed on efficacy population which excluded participants who were randomized to a treatment arm and discontinued based on the interim analysis (IA).|||Percentage of participants||95% Confidence Interval|Number
2562397|NCT02638597|Secondary|Heaviness of Smoking Index|The outcome measure was Heaviness of Smoking Index at exit. The Heaviness of Smoking Index is a two-item scale, with scores on each item rated on a 1-4 likert scale. The total score of the measure ranges from 2-8, with higher scores indicating worse outcome.|8 weeks after target quit date||||score on a scale||Standard Deviation|Mean
2562398|NCT02638597|Primary|Exhaled Carbon Monoxide (CO)|Exhaled carbon monoxide change from baseline to last available visit.|8 weeks after target quit date||||Parts p/million||Standard Deviation|Mean
2562399|NCT02638493|Secondary|Emtricitabine Triphosphate (FTCtp)/Deoxyadenosine Triphosphate (dCTP) Ratio in Seminal Mononuclear Cells|dCTP concentrations in seminal mononuclear cells will be measured and compared to emtricitabine triphosphate concentrations, using a ratio, and summarized descriptively for each subject, as well as across subjects. As the six seminal cell samples collected per man were pooled for analysis due to low cell recovery, a single ratio value per participant was calculated and summarized by study arm.|Average concentration in a 24 hour dosing interval||||FTCtp:dCTP ratio||Inter-Quartile Range|Median
2562400|NCT02638493|Secondary|Tenofovir Diphosphate (TFVdp)/Deoxyadenosine Triphosphate (dATP) Ratio in Seminal Mononuclear Cells|dATP concentrations in seminal mononuclear cells will be measured and compared to tenofovir diphosphate concentrations, using a ratio, and summarized descriptively for each subject, as well as across subjects. As the six seminal cell samples collected per man were pooled for analysis due to low cell recovery, a single ratio value per participant was calculated and summarized by study arm.|Average concentration in a 24 hour dosing interval||||TFVdp:dATP ratio||Inter-Quartile Range|Median
2562401|NCT02638493|Primary|Peripheral Blood Mononuclear Cell (PBMC) Clearance (CL) of Emtricitabine Triphosphate|Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of emtricitabine triphosphate, an intracellular metabolite of emtricitabine, from peripheral blood mononuclear cells, following a 200mg dose of emtricitabine.|Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose||||fmol/10 E6 cells||Inter-Quartile Range|Median
2562402|NCT02638493|Primary|Peripheral Blood Mononuclear Cell (PBMC) Clearance (CL) of Tenofovir Diphosphate|Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of tenofovir diphosphate, an intracellular metabolite of tenofovir, from peripheral blood mononuclear cells, following a 300mg dose of tenofovir.|Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose||||fmol/10 E6 cells||Inter-Quartile Range|Median
2562403|NCT02638493|Primary|Semen Clearance (CL) of Emtricitabine Triphosphate|Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of emtricitabine triphosphate, an intracellular metabolite of emtricitabine, from seminal mononuclear cells, following a 200mg dose of emtricitabine.|Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose|Semen (SMC) Steady State Concentrations (Css,ave) of Emtricitabine Triphosphate|||fmol/10 E6 cells||Inter-Quartile Range|Median
2562404|NCT02638493|Primary|Semen Clearance (CL) of Tenofovir Diphosphate|Samples will be analyzed for drug concentration at the following time points post dose: 3, 6, 9, 12, 18 and 24 hours, and used to estimate the clearance of tenofovir diphosphate, an intracellular metabolite of tenofovir, from seminal mononuclear cells, following a 300mg dose of tenofovir.|Samples collected at 3, 6, 9, 12, 18 and 24 hours post-dose||||fmol/10x6 cells||Inter-Quartile Range|Median
2562409|NCT02638337|Secondary|Change From Baseline in Sex Hormone-Binding Globulin at Week 12||Baseline and Week 12|Intent-to-treat population with available data|||nmol/L||Standard Deviation|Mean
2562413|NCT02638337|Secondary|Overall Satisfaction With Treatment at Week 12|Participants were asked to record their overall satisfaction with treatment in an electronic diary according to the following categories: Very satisfied, Moderately satisfied, About equally satisfied and dissatisfied, Moderately dissatisfied, and Very dissatisfied.|Week 12|Intent-to-treat population with available data|||Participants|||Count of Participants
2562414|NCT02638337|Secondary|Mean Days of Intercourse Per Week|The mean number of days/week of intercourse as recorded by participants in an electronic daily diary.|Week 1 to Week 12|Intent-to-treat population with available data|||days/week||Standard Deviation|Mean
2562415|NCT02638337|Secondary|Mean Days of Lubricant Use Per Week|The mean number of days/week that lubricant was used as documented by participants in an electronic daily diary.|Week 1 to Week 12|Intent-to-treat population with available data|||days/week||Standard Deviation|Mean
2562416|NCT02638337|Secondary|Change From Baseline in Procollagen 1 N-Terminal Propeptide (P1NP) at Week 12|Procollagen 1 N-terminal propeptide was measured as a marker of bone formation.|Baseline and Week 12|Intent-to-treat population with available data|||ng/mL||Standard Error|Least Squares Mean
2562417|NCT02638337|Secondary|Change From Baseline in Osteocalcin at Week 12|Osteocalcin was measured as a marker for bone formation.|Baseline and Week 12|Intent-to-treat population with available data|||ng/mL||Standard Error|Least Squares Mean
2562418|NCT02638337|Secondary|Change From Baseline in Bone-specific Alkaline Phosphatase at Week 12|Bone-specific alkaline phosphatase was measured as a marker of bone formation.|Baseline and Week 12|Intent-to-treat population with available data|||units/L||Standard Error|Least Squares Mean
2562419|NCT02638337|Secondary|Change From Baseline in Alkaline Phosphatase at Week 12|Alkaline phosphatase was measured as a marker of bone formation.|Baseline and Week 12|Intent-to-treat population with available data|||units/L||Standard Error|Least Squares Mean
2562420|NCT02638337|Secondary|Change From Baseline in Tartrate-Resistant Acid Phosphatase 5b at Week 12|Tartrate-resistant acid phosphatase 5b was measured as a marker of bone resorption.|Baseline and Week 12|Intent-to-treat population with available data|||units/L||Standard Error|Least Squares Mean
2562421|NCT02638337|Secondary|Change From Baseline in Type I Collagen N-Telopeptide (NTX) at Week 12|Type I collagen N-telopeptide was measured as a marker of bone resorption.|Baseline and Week 12|Intent-to-treat population with available data|||nmol bone collagen equivalents (BCE)/L||Standard Error|Least Squares Mean
2562422|NCT02638337|Secondary|Change From Baseline in Deoxypyridinoline at Week 12|Deoxypyridinoline was measured as a marker of bone resorption.|Baseline and Week 12|Intent-to-treat population with available data|||µmol/mol creatinine||Standard Error|Least Squares Mean
2562423|NCT02638337|Secondary|Change From Baseline in Type I Collagen C-Telopeptide (CTX) at Week 12|Type I collagen C-telopeptide was measured as a marker of bone resorption.|Baseline and Week 12|Intent-to-treat population with available data|||ng/mL||Standard Error|Least Squares Mean
2562424|NCT02638337|Secondary|Change From Baseline in Bone Sialoprotein at Week 12|Serum bone sialoprotein (BSP) was measured as a marker of bone resorption.|Baseline and Week 12|Intent-to-treat population with available data|||pg/mL||Standard Error|Least Squares Mean
2562425|NCT02638337|Secondary|Change From Baseline in Urinary Distress Inventory (UDI)-6 Total Score|"The presence or absence of urinary symptoms was assessed using the Urinary Distress Inventory (UDI)-6. The symptoms include frequent urination, urine leakage related to the feeling of urgency, urine leakage related to physical activity, coughing, or sneezing, small amounts of urine leakage, difficulty emptying bladder, and pain and discomfort in the lower abdominal or genital area. If a symptom was present, participants were asked to assess the degree to which they were bothered by it on the following 4-point scale:~= present but doesn't bother her at all;~= present and bothers her slightly;~= present and bothers her moderately;~= present and bothers her greatly. The total score was calculated by adding the 6 scores together (Absent = 0), and ranges from 0 to 24, with lower values indicating less urinary distress."|Baseline and Weeks 4, 8, and 12|Intent-to-treat population with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2562426|NCT02638337|Secondary|Change From Baseline in Female Sexual Function Index Domain Scores at Week 12|"The Female Sexual Function Index consists of 19 questions, organized into 6 domains (desire, arousal, lubrication, orgasm, satisfaction, and pain), answered by the participant on a scale from 1 to 5. Where relevant, some questions also include an option of 0 if not applicable due to no sexual activity. Each domain score was calculated by adding the scores of each item in the domain and multiplying by a domain factor. For all domains, higher values indicate better sexual function, according to the following:~Desire (2 questions): domain score ranges from 1.2 to 6; Arousal (4 questions): domain score ranges from 0 to 6; Lubrication (4 questions): domain score ranges from 0 to 6; Orgasm (3 questions): domain score ranges from 0 to 6; Satisfaction (3 questions): domain score ranges from 0.8 to 6; Pain (3 questions): domain score ranges from 0 to 6."|Baseline and Week 12|Intent-to-treat population with available baseline and Week 12 data|||units on a scale||Standard Error|Least Squares Mean
2562427|NCT02638337|Secondary|Change From Baseline in Female Sexual Function Index Total Score|The Female Sexual Function Index consists of 19 questions organized into 6 domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) answered by the participant on a 5-point scale from 1 to 5. Where relevant, some questions also include an option of 0 if a question is not applicable due to no sexual activity. Each domain score was calculated by adding the scores of each item in the domain and multiplying by a domain factor. The total score was calculated by summing each domain score and ranges from 2 to 36, with higher values indicating better sexual function.|Baseline and Weeks 4, 8, and 12|Intent-to-treat population with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2562428|NCT02638337|Secondary|Change From Baseline in Vulvovaginal Imaging Total Score at Week 12|Vulvovaginal imaging was performed by trained site personnel following a standard procedure. Photographs were assessed by an Independent Panel Review (IPR) in a blinded fashion. Nine parameters (labia majora, labia minora, clitoris, urethra, introitus and elasticity, color, erythema, moisture, and other findings (petechiae, excoriation, ulceration, etc.)) were evaluated on a scale from 0 (normal/none) to 3 (severe). The total score was calculated from the sum of the 9 individual scores and ranged from 0 to 27 with lower values indicating better vulvovaginal health; a negative change from baseline indicates improvement.|Baseline and Week 12|Intent-to-treat population; participants who agreed to participate in the optional vaginal imaging, and with available data at both time points were included.|||units on a scale||Standard Error|Least Squares Mean
2562429|NCT02638337|Secondary|Change From Baseline in Vulvar Health Index|The investigator performed a visual examination of the vulva, assessing the labia majora, labia minora, clitoris, introitus appearance and elasticity, color, discomfort and pain, and presence of other findings (eg, petechiae, excoriations, ulcers, etc). The severity of each characteristic was assessed on a 4-point scale as 0 = normal, 1 = mild, 2 = moderate, and 3 = severe. The total score was calculated by adding the 7 individual scores and ranges from 0 to 21, where lower scores indicate better vulvar health. A negative change from baseline indicates improvement.|Baseline and Weeks 4, 8, and 12|Intent-to-treat population with available data at each timepoint|||units on a scale||Standard Error|Least Squares Mean
2562430|NCT02638337|Secondary|Change From Baseline in Vaginal Health Index|The investigator performed an evaluation of the vagina, assessing overall elasticity, fluid secretion, pH, condition of epithelial mucosa, and moisture. The severity of each characteristic was assessed using a 5-grade scale from 1 (worst) to 5 (best). The total score was calculated as the sum of the 5 individual scores and ranges from 5 to 25, where higher scores indicate better vaginal health|Baseline and Weeks 4, 8, and 12|Intent-to-treat population with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2562431|NCT02638337|Secondary|Percentage of Participants Who Were Responders at Week 4, Week 8, and Week 12|"A participant was defined as a responder if all the following conditions were met::~Increase from baseline in maturation value of at least 10~Decrease from baseline in vaginal pH of at least 0.5~Improvement from baseline (decrease in severity) of at least 1 point in the most bothersome symptom of vaginal dryness"|Baseline and Weeks 4, 8, and 12|Intent-to-treat population with available data at each time point|||percentage of participants|||Number
2562432|NCT02638337|Secondary|Change From Baseline in Maturation Value|"The maturation value is an indicator of the level of maturation attained by the vaginal epithelium.~Vaginal smear samples were taken from the middle third of the lateral vaginal wall and were evaluated at the central laboratory by a qualified pathologist. Parabasal cells (P), intermediary cells (I), and superficial cells (S) were counted and results were expressed as the maturation value (MV), whereby superficial cells were assigned a point value of 1.0, intermediate cells were assigned a point value of 0.5, and parabasal cells were assigned a point value of 0. The maturation value (MV) was defined as:~(percentage of superficial cells * 1) + (percentage of intermediate cells * 0.5) + (percentage of parabasal calls * 0).~Lower MV indicates lower estrogen effect."|Baseline and Weeks 4, 8, and 12|Intent-to-treat population with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2562433|NCT02638337|Secondary|Change From Baseline in Vaginal Bleeding Associated With Sexual Activity|The severity of vaginal bleeding associated with sexual activity was assessed by the participant through the VVA questionnaire as none = 0, mild = 1, moderate = 2, and severe = 3.|Baseline and Weeks 4, 8, and 12|Intent-to-treat population; participants whose baseline values were moderate or severe were included|||units on a scale||Standard Deviation|Mean
2562434|NCT02638337|Secondary|Change From Baseline in Vaginal Pain Associated With Sexual Activity|The severity of vaginal pain associated with sexual activity was assessed by the participant through the VVA questionnaire as none = 0, mild = 1, moderate = 2, and severe = 3.|Baseline and Weeks 4, 8, and 12|Intent-to-treat population; participants whose baseline values were moderate or severe were included|||units on a scale||Standard Deviation|Mean
2562435|NCT02638337|Secondary|Change From Baseline in Difficult or Painful Urination|The severity of difficult or painful urination was assessed by the participant through the VVA questionnaire as none = 0, mild = 1, moderate = 2, and severe = 3.|Baseline and Weeks 4, 8, and 12|Intent-to-treat population; participants whose baseline values were moderate or severe were included.|||units on a scale||Standard Deviation|Mean
2562436|NCT02638337|Secondary|Change From Baseline in Vaginal and/or Vulvar Irritation or Itching|The severity of vaginal and/or vulvar irritation or itching was assessed by the participant through the VVA questionnaire as none = 0, mild = 1, moderate = 2, and severe = 3.|Baseline and Weeks 4, 8, and 12|Intent-to-treat population; participants whose baseline values were moderate or severe were included|||units on a scale||Standard Deviation|Mean
2562437|NCT02638337|Secondary|Change From Baseline in the Severity of Self-reported Most Bothersome Symptom (MBS) of Vaginal Dryness at Weeks 4 and 8|The severity of the most bothersome symptom of vaginal dryness was assessed by the participant through the VVA questionnaire as none = 0, mild = 1, moderate = 2, and severe = 3.|Baseline and Weeks 4 and 8|Intent-to-treat population with available data at baseline|||units on a scale||Standard Deviation|Mean
2562438|NCT02638337|Secondary|Change From Baseline in the Vaginal pH|The pH scale ranges from 0 to 14. A pH of 7 is neutral, less than 7 is acidic, and greater than 7 is basic. A typical vaginal pH in women of reproductive age is between 3.5 and 4.5, increasing to > 4.5 after menopause. Vaginal pH was measured by the investigator using a pH indicator strip at the middle third of the vaginal wall.|Baseline and Weeks 4 and 8|Intent-to-treat population with available baseline data|||pH||Standard Error|Least Squares Mean
2562439|NCT02638337|Secondary|Change From Baseline in the Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear at Weeks 4 and 8|Superficial cells are mature squamous cells in the lining of the vagina that can decrease in number after menopause resulting in vulvovaginal atrophy. Vaginal smear samples were taken from the middle third of the lateral vaginal wall and were evaluated at a central laboratory by a qualified pathologist. An increase in the number of superficial cells indicates improvement in atrophy.|Baseline and Weeks 4 and 8|Intent-to-treat population with available baseline data|||percentage of cells||Standard Error|Least Squares Mean
2562440|NCT02638337|Secondary|Change From Baseline in the Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear at Weeks 4 and 8|Parabasal cells are immature squamous cells in the lining of the vagina. A predominance of parabasal cells indicates absence of estrogenic stimulation and vaginal atrophy. Vaginal smear samples were taken from the middle third of the lateral vaginal wall and were evaluated at a central laboratory by a qualified pathologist. A decrease in parabasal cells indicates improvement in vaginal atrophy.|Baseline and Weeks 4 and 8|Intent-to-treat population with baseline data|||percentage of cells||Standard Error|Least Squares Mean
2562457|NCT02638259|Secondary|Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria|Proportion of patients achieving EULAR/ACR Boolean remission criteria (defined as number of tender joints/swollen joints ≤ 1 and CRP (mg/dL) ≤ 1 and patient global assessment (1-10) ≤ 1) at Weeks 36 and 48;|week 4, week 12, week 24, week 36, week 48|Treatment period 2 per protocol set. Patients with data available|||Participants|||Count of Participants
2562441|NCT02638337|Primary|Number of Participants With Adverse Events|"Treatment-related adverse events (AEs) were defined as AEs that were considered by the investigator to be related to investigational medicinal product, for which causal relationship with the study drug could be reasonably explained.~A serious adverse event (SAE) is defined as any AE occurring at any dose that resulted in any of the following outcomes:~Death~Life-threatening condition~Hospitalization or prolongation of existing hospitalization for treatment~Persistent or significant disability/incapacity~Congenital anomaly/birth defect~Other medically important conditions that, based on medical judgment, may jeopardize the participant's health and may require medical intervention to prevent one of the outcomes listed above."|From the first dose of study drug up to 14 days after the last dose; 14 weeks|Participants who received at least 1 dose of study drug. Four participants randomized to placebo received ospemifene in error and are counted in the ospemifene group for safety assessments. One participant randomized to placebo who enrolled at 2 different sites at the same time was excluded.|||Participants|||Count of Participants
2562442|NCT02638337|Primary|Change From Baseline in the Severity of Self-reported Most Bothersome Symptom (MBS) of Vaginal Dryness at Week 12|The severity of the most bothersome symptom of vaginal dryness was assessed by the participant through the VVA questionnaire as none = 0, mild = 1, moderate = 2, and severe = 3.|Baseline and Week 12|Intent-to-treat population with available baseline data|||units on a scale||Standard Deviation|Mean
2562443|NCT02638337|Primary|Change From Baseline in the Vaginal pH at Week 12|"The pH scale ranges from 0 to 14. A pH of 7 is neutral, less than 7 is acidic, and greater than 7 is basic. A typical vaginal pH in women of reproductive age is between 3.5 and 4.5, increasing to > 4.5 after menopause.~Vaginal pH was measured by the investigator using a pH indicator strip at the middle third of the vaginal wall.~To calculate least squares (LS) means, a mixed-effects model for repeated measures (MMRM) model was used."|Baseline and Week 12|Intent-to-treat population with available baseline data|||pH||Standard Error|Least Squares Mean
2562444|NCT02638337|Primary|Change From Baseline in the Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear at Week 12|"Superficial cells are mature squamous cells in the lining of the vagina that can decrease in number after menopause resulting in vulvovaginal atrophy.~Vaginal smear samples were taken from the middle third of the lateral vaginal wall and were evaluated at a central laboratory by a qualified pathologist.~An increase in the number of superficial cells indicates improvement in atrophy.~To calculate least squares (LS) means, a mixed-effects model for repeated measures (MMRM) model was used."|Baseline and Week 12|Intent-to-treat population with available baseline data|||percentage of cells||Standard Error|Least Squares Mean
2562445|NCT02638337|Primary|Change From Baseline in the Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear at Week 12|"Parabasal cells are immature squamous cells in the lining of the vagina. A predominance of parabasal cells indicates absence of estrogenic stimulation and vaginal atrophy.~Vaginal smear samples were taken from the middle third of the lateral vaginal wall and were evaluated at a central laboratory by a qualified pathologist.~A decrease in parabasal cells indicates improvement in vaginal atrophy. To calculate least squares (LS) means, a mixed-effects model for repeated measures (MMRM) model was used."|Baseline and Week 12|Intent-to-treat population with available baseline data|||percentage of cells||Standard Error|Least Squares Mean
2562446|NCT02638259|Secondary|Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients|To assess the immunogenicity of continuous GP2015 treatment versus a treatment transition from Enbrel to GP2015 after 24 weeks of treatment by measuring the rate of ADA positive participants at Weeks 24, 30, 36 and 48. summary of ADA positive data up to week 48 using a 1% false positive cut point|baseline, week 4, week 12, week 24, week 36, week 48|Safety Set|||Participants|||Count of Participants
2562447|NCT02638259|Secondary|Safety - Overall Study : Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel|Frequency of participants with injection site reactions in GP2015 and Enbrel|up to 48 weeks|Safety Set|||Participants|||Count of Participants
2562448|NCT02638259|Secondary|Treatment Period 2 : ESR Levels at Week 36 and 48||baseline, week 4, week 12, week 24, week 36, week 48|Treatment period 2 per protocol set. Patients with data available|||mm/h||Standard Deviation|Mean
2562449|NCT02638259|Secondary|Treatment Period 2 : CRP Levels at Week 36 and 48||baseline, week 4, week 12, week 24, week 36, week 48|Treatment period 2 per protocol set. Patients with data available|||mg/dL||Standard Deviation|Mean
2562450|NCT02638259|Secondary|Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48;|FACIT: from 0 (worst) to 52 (best), a score of less than 30 indicates severe fatigue|baseline, week 4, week 12, week 24, week 36, week 48|Treatment period 2 per protocol set. Patients with data available|||score on a scale||Standard Deviation|Mean
2562451|NCT02638259|Secondary|Treatment Period 2 :HAQ Index at Weeks 36 and 48;|HAQ: from 0 (best) to 3 (worst)|baseline, week 4, week 12, week 24, week 36, week 48|Treatment period 2 per protocol set. Patients with data available|||score on a scale||Standard Deviation|Mean
2562452|NCT02638259|Secondary|Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 36 and 48;||baseline, week 4, week 12, week 24, week 36, week 48|Treatment period 2 per protocol set. Patients with data available|||Participants|||Count of Participants
2562453|NCT02638259|Secondary|Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI|Proportion of patients in each disease activity category as defined by the Clinical Disease Activity Index (CDAI): high disease activity, CDAI > 22, moderate disease activity, CDAI > 10 to ≤ 22, low disease activity, CDAI > 2.8 to ≤ 10, and remission, CDAI ≤ 2.8 at Weeks 36 and 48;|baseline, week 4, week 12, week 24, week 36 and week 48|Treatment period 2 per protocol set. Patients with data available|||Participants|||Count of Participants
2562454|NCT02638259|Secondary|Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI|Proportion of patients in each disease activity category as defined by the Simplified Disease Activity Index (SDAI): high disease activity, SDAI > 26, moderate disease activity, SDAI > 11 to ≤ 26, low disease activity, SDAI > 3.3 to ≤ 11, and remission, SDAI ≤ 3.3 at Weeks 36 and 48.|baseline, week 4, week 12, week 24, week 36. week 48|Treatment period 2 per protocol set. Patients with data available|||Participants|||Count of Participants
2562455|NCT02638259|Secondary|Treatment Period 2 : ACR-N Scores at Weeks 36 and 48;|ACR-N: negative is worsening, positive (up to 100) is an improvement|week 36 and week 48|Treatment period 2 per protocol set. Patients with data available|||score on a scale||Standard Deviation|Mean
2562459|NCT02638259|Secondary|Treatment Period 2: Proportion of Patients Achieving EULAR Reponse|Proportion of patients achieving EULAR good response (defined as DAS28 ≤ 3.2 and DAS28 improvement from Baseline > 1.2) and moderate response (defined as DAS28 ≤ 3.2 and DAS28 improvement > 0.6 and ≤ 1.2, or DAS28 > 3.2 and ≤ 5.1 and DAS28 improvement > 0.6 or DAS28 > 5.1 but DAS28 improvement > 1.2) at Weeks 36 and 48;|week 4, week 12, week 24, week 36 and week 48|Treatment period 2 per protocol set. Patients with data available|||Participants|||Count of Participants
2562460|NCT02638259|Secondary|Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48||week 4, week 12, week 24, week 36, week 48|Treatment period 2 per protocol set. Patients with data available|||score on a scale||Standard Deviation|Mean
2562461|NCT02638259|Secondary|Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48;|"DAS28-CRP and DAS28-ESR:~best is 0,~< 2.6 - remission,~≥ 2.6 to ≤ 3.2 - low disease activity~> 3.2 to ≤ 5.1 - moderate disease activity~> 5.1 - high disease activity"|Baseline, week 4, week 12, week 24, week 36 and week 48.|Treatment period 2 per protocol set. Patients with data available|||score on a scale||Standard Deviation|Mean
2562462|NCT02638259|Secondary|Treatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24||Weeks 4, 12 and 24|Treatment period 1 per protocol set. Patients with data available|||mm/h||Standard Deviation|Mean
2562463|NCT02638259|Secondary|Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24||Weeks 4, 12 and 24|Treatment period 1 per protocol set. Patients with data available|||mg/dL||Standard Deviation|Mean
2562464|NCT02638259|Secondary|Treatment Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24;|FACIT fatigue scale is a 13- item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function, ranging from 0 (worst) to 52 (best). A score of less than 30 indicates severe fatigue.|Baseline, Weeks 4, 12 and 24;|Treatment period 1 per protocol set. Patients with data available|||score on a scale||Standard Deviation|Mean
2562465|NCT02638259|Secondary|Treatment Period 1 - Health Assessment Questionnaire (HAQ) Index at Baseline, Weeks 4, 12 and 24;|Health assessment questionnaire (HAQ) disability index ranges from 0 (best) to 3 (worst)|Baseline, Weeks 4, 12 and 24;|Treatment period 1 per protocol set. Patients with data available|||score on a scale||Standard Deviation|Mean
2562466|NCT02638259|Secondary|Treatment Period 1- Proportion of Patients Achieving HAQ Index in Normal Range (≤ 0.5) at Weeks 4, 12 and 24;|Health assessment questionnaire (HAQ) disability index ranges from 0 (best) to 3 (worst)|Weeks 4, 12 and 24;|Treatment period 1 per protocol set. Patients with data available|||Participants|||Count of Participants
2562467|NCT02638259|Secondary|Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI|Proportion of patients in each disease activity category as defined by the Clinical Disease Activity Index (CDAI): high disease activity, CDAI > 22, moderate disease activity, CDAI > 10 to ≤ 22, low disease activity, CDAI > 2.8 to ≤ 10, and remission, CDAI ≤ 2.8 at Weeks 4, 12 and 24; SDAI and CDAI are measures of disease activity in RA. The scores were calculated by numerical summation of the number of tender and swollen joints (using the 28-joint count), and the patient's and physician's global assessment of disease activity.|Weeks 4, 12 and 24;|Treatment period 1 per protocol set. Patients with data available|||Participants|||Count of Participants
2562468|NCT02638259|Secondary|Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI|Proportion of patients in each disease activity category as defined by the Simplified Disease Activity Index (SDAI): high disease activity, SDAI > 26, moderate disease activity, SDAI > 11 to ≤ 26, low disease activity, SDAI > 3.3 to ≤ 11, and remission, SDAI ≤ 3.3 at Weeks 4, 12 and 24; SDAI and CDAI are measures of disease activity in RA. The scores were calculated by numerical summation of the number of tender and swollen joints (using the 28-joint count), and the patient's and physician's global assessment of disease activity.|Weeks 4, 12 and 24;|Treatment period 1 per protocol set. Patients with data available|||Participants|||Count of Participants
2562469|NCT02638259|Secondary|Treatment Period 1- ACR-N Scores at Weeks 4, 12 and 24;|"ACR-N (American College of Rheumatology percentage of improvement): negative is worsening, positive (up to 100) is an improvement.~ACR-N is a single number that characterizes the percentage of improvement from Baseline that a patient has experienced in analogy to ACR20 described above. ACR-N of X (such as 38) means that the patient had achieved an improvement of at least X% (such as 38%) in tender and swollen joints, and an improvement of at least X% (such as 38%) in 3 of the 5 other parameters mentioned above."|Weeks 4, 12 and 24;|Treatment period 1 per protocol set. Patients with data available|||score on a scale||Standard Deviation|Mean
2562470|NCT02638259|Secondary|Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24;|"ACR20 response was defined if a patient fulfilled all 3 criteria below:~20% improvement in tender 68 joint-count~20% improvement in swollen 68 joint-count;~And 20% improvement in at least 3 of the following 5 measures:~Patient's assessment of RA pain (visual analogue scale (VAS) 100 mm),~Patient's global assessment of disease activity (VAS 100 mm),~Physician's global assessment of disease activity (VAS 100 mm),~Patient self-assessed disability (HAQ score),~Acute phase reactant (CRP or ESR). ACR50 and ACR70 responses were defined as ACR20 response replacing 20% improvement by 50% improvement and 70% improvement, respectively."|Week 4, week 12 and week 24|Treatment period 1 per protocol set. Patients with data available|||Participants|||Count of Participants
2562471|NCT02638259|Secondary|Treatment Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria|Proportion of patients achieving EULAR/American College of Rheumatology (EULAR/ACR) Boolean remission criteria (defined as number of tender joints/swollen joints ≤ 1 and CRP (mg/dL) ≤ 1 and patient global assessment (1-10) ≤ 1) at Weeks 4, 12 and 24;|week 4, week 12, week 24|Treatment period 1 per protocol set. Patients with data available|||Participants|||Count of Participants
2562472|NCT02638259|Secondary|Treatment Period 1- Proportion of Patients Achieving DAS28 < 2.6 at Weeks 4, 12 and 24|% patients in DAS28-ESR categories up to week 24|week 4, week 12 and week 24|Treatment period 1 per protocol set. Patients with data available|||Participants|||Count of Participants
2562473|NCT02638259|Secondary|Treatment Period 1- Proportion of Patients Achieving EULAR Response|Proportion of patients achieving European League against Rheumatism (EULAR) good response (defined as DAS28 ≤ 3.2 and DAS28 improvement from Baseline > 1.2) and moderate response (defined as DAS28 ≤ 3.2 and DAS28 improvement > 0.6 and ≤ 1.2, or DAS28 > 3.2 and ≤ 5.1 and DAS28 improvement > 0.6 or DAS28 > 5.1 but DAS28 improvement > 1.2) ;|week 4, week 12 and week 24|Treatment period 1 per protocol set. Patients with data available|||Participants|||Count of Participants
2562475|NCT02638259|Secondary|Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24;|"DAS28-CRP is a disease activity score and defined in primary outcome measure. DAS28-ESR is the DAS28 erythrocyte sedimentation rate score.~DAS28-CRP and DAS28-ESR:~best is 0,~< 2.6 - remission,~≥ 2.6 to ≤ 3.2 - low disease activity~> 3.2 to ≤ 5.1 - moderate disease activity~> 5.1 - high disease activity~DAS28-ESR = 0.56 * sqrt(tender28) + 0.28* sqrt(swollen28) + 0.7 * ln(ESR) + 0.014 * GDA where • tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count • CRP is C-reactive protein (mg/l) • ESR is erythrocyte sedimentation rate (mm/h) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm"|week 4, 12, 24|Treatment period 1 per protocol set. Patients with data available|||score on a scale||Standard Deviation|Mean
2562476|NCT02638259|Secondary|Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients|Frequency of patients having anti-drug antibody (ADA) during 24 weeks (Treatment Period 1) using 1% false positive rate|baseline, week 2, week 4, week 12, week 24|Safety Set|||Participants|||Count of Participants
2562477|NCT02638259|Secondary|Treatment Period 1: Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel|Frequency of participants with injection site reactions in GP2015 and Enbrel|Treatment Period 1, up to 24 weeks|Safety Set|||Participants|||Count of Participants
2562478|NCT02638259|Primary|Safety: Change in DAS28-CRP Score From Baseline to Week 24 in Patients Treated With GP2015 and Patients Treated With Enbrel|Disease activity score (DAS) 28-CRP is based on 28-joint count (tender and swollen joints), C-reactive protein and patient's assessment of global disease activity, values range from 0.96 to 10.0 while higher values mean a higher disease activity. • A DAS28-CRP value >5.1 corresponds to a high disease activity • A DAS28-CRP value between 3.2 and 5.1 corresponds to a moderate disease activity • A DAS28-CRP value between 2.6 and 3.2 corresponds to a low disease activity • A DAS28-CRP value < 2.6 corresponds to remission DAS28-CRP = 0.56 * sqrt(tender28) + 0.28* sqrt(swollen28) + 0.36 * ln(CRP+1) + 0.014 * GDA + 0.96 where • tender28 and swollen28 are the number of tender and swollen joints as assessed using 28-joint count • CRP is C-reactive protein (mg/l) • GDA is the global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm|treatment period 1: up to 24 weeks|Treatment Period 1 Per-Protocol set|||scores on a scale||Standard Error|Least Squares Mean
2562479|NCT02638168|Secondary|Affective Reactivity Index (ARI)|Higher scores mean a worse symptoms This scales has 7 items, which are reported as Not true (0), somewhat true (1) certainly true (2) Total score is calculated by summiting all items. Total Score Ranges (0-14)|3 weeks||||score on a scale||Full Range|Mean
2562480|NCT02638168|Secondary|Parent Rated 10-item IOWA|Higher scores mean severe symptoms This scales has 10 items, which are reported as Not at all (0), just a little (1), pretty much (2) and very much (3) Total score is calculated by summiting all items. Total Score Ranges (0-30)|3 weeks||||score on a scale||Full Range|Mean
2562481|NCT02638168|Secondary|Night to Night Variability (Weekends & Weekdays) - in Sleep Onset Latency Measured by Actigraphy|We calculated Night to night variability by the difference between the mean sleep onset latency during the weekend days and the mean sleep onset latency during the weekdays.|3 weeks||||minutes||Full Range|Mean
2562482|NCT02638168|Secondary|Length of Wakings||3 weeks||||minutes||Full Range|Mean
2562483|NCT02638168|Secondary|Number of Wakings||3 weeks||||Wakings||Full Range|Mean
2562484|NCT02638168|Secondary|Sleep Efficiency||3 weeks||||percentage of time spent asleep in bed||Full Range|Mean
2562485|NCT02638168|Secondary|Wake After Sleep Onset (WASO)||3 weeks||||minutes||Full Range|Median
2562486|NCT02638168|Secondary|Total Sleep Time||3 weeks||||minutes||Full Range|Mean
2562487|NCT02638168|Secondary|Sleep Offset||3 weeks||||minutes||Full Range|Mean
2562488|NCT02638168|Secondary|Pittsburgh Side Effects Rating Scale|Pittsburgh Side Effects Rating Scale to evaluate adverse reactions to Methylphenidate Higher scores mean a worse outcome (more side effects with medication) This scales has 13 items, which are reported as None (0), Mild (1), Moderate (2) and Severe (3) Total score is calculated by summiting all items. Total Score Ranges (0-39)|3 weeks||||score on a scale||Full Range|Mean
2562489|NCT02638168|Secondary|Sleep Onset Latency (SOL), Defined as Time in Bed Until Sleep by Actigraphy|Sleep onset latency is defines as duration of time in bed until sleep actigraphy|3 weeks||||minutes||Full Range|Mean
2562490|NCT02638168|Primary|Sleep Onset Latency (SOL) as Reported on the Parent Completed Sleep Log|Sleep onset latency is defines as duration of time in bed until sleep, as reported on the parent completed sleep log|3 weeks||||minutes||Full Range|Mean
2562491|NCT02638129|Secondary|Time From Treatment Period Randomization to the Occurrence of Cardiovascular Death||Day 1 to the occurrence of cardiovascular death (up to 6 years)|The trial was prematurely terminated. Due to the short trial duration and as a result of very limited participant follow-up, insufficient data was collected (or did not exist) to allow for a statistical analysis as described in the protocol. The necessary and sufficient data to conduct the primary and secondary analyses was not available.||||||
2562492|NCT02638129|Secondary|Time From Treatment Period Randomization to the Occurrence of All-Cause Death||Day 1 to the occurrence of all-cause death (up to 6 years)|The trial was prematurely terminated. Due to the short trial duration and as a result of very limited participant follow-up, insufficient data was collected (or did not exist) to allow for a statistical analysis as described in the protocol. The necessary and sufficient data to conduct the primary and secondary analyses was not available.||||||
2562493|NCT02638129|Secondary|Time From Treatment Period Randomization to the First Confirmed Occurrence of Extended Major Adverse Cardiovascular Events (MACE)|Extended MACE defined as cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and unstable angina requiring hospitalization.|Day 1 to first confirmed occurrence of extended MACE (up to 6 years)|The trial was prematurely terminated. Due to the short trial duration and as a result of very limited participant follow-up, insufficient data was collected (or did not exist) to allow for a statistical analysis as described in the protocol. The necessary and sufficient data to conduct the primary and secondary analyses was not available.||||||
2562508|NCT02638051|Secondary|Quality of Life (QoL)|"Karnofsky Performance Score Improvement Rate (KPS IR)~Improvement: increase of KPS for ≥10% after treatment.~Worsening: reduction of KPS for ≥10% after treatment.~NC: change of KPS for <10%."|8 weeks after start of treatment (4 weeks on completion of treatment)||||percentage of participants|||Number
2562494|NCT02638129|Primary|Time From Treatment Period Randomization to the First Confirmed Occurrence of Major Adverse Cardiovascular Events (MACE)|MACE are defined as cardiovascular death, nonfatal myocardial infarction and nonfatal stroke.|Day 1 to first confirmed occurrence of MACE (up to 6 years)|The trial was prematurely terminated. Due to the short trial duration and as a result of very limited participant follow-up, insufficient data was collected (or did not exist) to allow for a statistical analysis as described in the protocol. The necessary and sufficient data to conduct the primary and secondary analyses was not available.||||||
2562495|NCT02638103|Primary|Number of Participants With Suicidal Ideation and Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)|"eC-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent."|Baseline (Day -28 to Day -1), Month 12|Safety population included all participants who received at least 1 dose of fremanezumab.|||Participants|||Count of Participants
2562496|NCT02638103|Primary|Number of Participants With Injection Site Reactions|Number of participants who reported treatment-emergent injection site reactions are summarized. Preferred terms from MedDRA version 18.1 were offered without a threshold applied. Injection site reactions included injection site induration, pain, erythema, haemorrhage, pruritus, swelling, bruising, rash, urticaria, warmth, dermatitis, haematoma, inflammation, discolouration, discomfort, hypersensitivity, hypoaesthesia, irritation, oedema, papule, paraesthesia, vesicles and pallor. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline (Day -28 to Day -1), Month 12|Safety population included all participants who received at least 1 dose of fremanezumab.|||Participants|||Count of Participants
2562497|NCT02638103|Other Pre-specified|Percentage of Participants With At Least 50% Reduction From Baseline in Monthly Average Number of Headache Days of at Least Moderate Severity During the 4-Week Period|Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of at least moderate severity for both CM and EM participants was defined as a calendar day (00:00 to 23:59) where the participant (using the electronic headache diary device) reports: a day with headache pain that lasts at least 4 hours with a peak severity of at least moderate severity or; a day when the participant used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) * 28.|Baseline (Day -28 to Day -1), Month 12|FAS: all participants who received at least 1 dose of fremanezumab, and had at least 10 days of efficacy assessments by electronic diary after first injection for this study. Data for this outcome was collected and reported separately for CM and EM participants. ‘Overall number of participants analyzed' = participants evaluable for this outcome.|||percentage of participants|||Number
2562498|NCT02638103|Other Pre-specified|Percentage of Participants With At Least 50% Reduction From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period at Month 12|A migraine day was defined as when at least 1 of the following situations occurred: A calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for migraine with or without aura; a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period) * 28.|Baseline (Day -28 to Day -1), Month 12|FAS: all participants who received at least 1 dose of fremanezumab, and had at least 10 days of efficacy assessments by electronic diary after first injection for this study. Data for this outcome was collected and reported separately for CM and EM participants. ‘Overall number of participants analyzed' = participants evaluable for this outcome.|||percentage of participants|||Number
2562499|NCT02638103|Primary|Number of Participants With Shift From Baseline to Endpoint in Coagulation Laboratory Test Results|Coagulation parameters included: prothrombin time (PT) (seconds), prothrombin international normalized ratio (INR), activated partial thromboplastin time (aPTT) (seconds). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Shifts from baseline to endpoint were summarized using participant counts grouped into three categories: - Low (below normal range) - Normal (within the normal range of 9.4 to 12.5 seconds) - High (above normal range). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline (Day 0), endpoint (Day 336)|Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed' = participants with both baseline and endpoint coagulation laboratory test results. 'Number analyzed' = participants evaluable for specified categories.|||Participants|||Count of Participants
2562500|NCT02638103|Primary|Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters|ECG parameters included: heart rate, PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF), QT interval corrected using the Bazett's formula (QTcB) and RR interval. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline (Day 0), endpoint (Day 336)|Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed' = participants with both baseline and endpoint electrocardiogram findings.|||Participants|||Count of Participants
2562509|NCT02638051|Secondary|Adverse Events Rate (AER)|Common Terminology Criteria for Adverse Events (CTCAE) (v4.03: June 14, 2010) U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES, National Institutes of Health, National Cancer Institute.|During 4 weeks of treatment course and 4 weeks after treatment||||participants|||Number
2562501|NCT02638103|Primary|Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Values|Potentially clinically significant abnormal vital signs findings included: pulse rate: <=50 beats/minute (bpm) and decrease of >=15 bpm, or >=120 bpm and increase of >=15 bpm; systolic blood pressure: <=90 millimeters of mercury (mmHg) and decrease of >=20 mmHg, or >=180 mmHg and increase of >=20 mmHg; diastolic blood pressure: <=50 mmHg and decrease of >=15 mmHg or >=105 mmHg and increase of >=15 mmHg; respiratory rate: <10 breaths/minute; and body temperature >=38.3 degrees centigrade and change of >=1.1 degrees centigrade. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline (Day 0) up to EOT visit (Day 336)|Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed'=participants with both baseline and post-baseline vital signs values.|||Participants|||Count of Participants
2562502|NCT02638103|Primary|Number of Participants With Potentially Clinically Significant Abnormal Urinalysis Laboratory Tests Results|Potentially clinically significant abnormal urinalysis findings included: blood: >=2 unit increase from baseline, urine glucose (milligrams/decilitre [mg/dL]): >=2 unit increase from baseline, ketones (mg/dL): >=2 unit increase from baseline, urine protein (mg/dL): >=2 unit increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline (Day 0) up to EOT visit (Day 336)|Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed'=participants with both baseline and post-baseline urinalysis values.|||Participants|||Count of Participants
2562503|NCT02638103|Primary|Number of Participants With Potentially Clinically Significant Abnormal Hematology Results|Potentially clinically significant abnormal hematology findings included: hemoglobin: less than (<) 115 grams/liter (g/L) (in males) or less than or equal to (<=) 95 g/L (in females), hematocrit: <0.37 L/L (in male) or <0.32 L/L (in female), leukocytes: >=20*10^9/L or <=3*10^9/L, eosinophils/leukocytes: >=10%, and platelets: >=700*10^9/L or <=75*10^9/L. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline (Day 0) up to EOT visit (Day 336)|Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed'=participants with both baseline and post-baseline hematology parameter values.|||Participants|||Count of Participants
2562504|NCT02638103|Primary|Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results|Potentially clinically significant abnormal serum chemistry findings included: Blood Urea Nitrogen (BUN): greater than or equal to (>=) 10.71 millimoles/liter (mmol/L), creatinine: >=177 micromoles/liter (µmol/L), bilirubin: >=34.2 µmol/L, Alanine Aminotransferase (ALT) (units/liter [U/L]): >=3*upper limit of normal (ULN) Aspartate Aminotransferase (AST) (U/L): >=3*ULN, and Gamma Glutamyl Transferase (GGT) (U/L): >=3*ULN. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline (Day 0) up to end of treatment (EOT) visit (Day 336)|Safety population included all participants who received at least 1 dose of fremanezumab. Here, 'Overall number of participants analyzed'=participants with both baseline and post-baseline serum chemistry values.|||Participants|||Count of Participants
2562505|NCT02638103|Other Pre-specified|Change From Baseline in Monthly Average Number of Headache Days of Any Severity During the 4-Week Period at Month 12|Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of any severity for both CM and EM participants was defined as a calendar day (00:00 to 23:59) where the participant (using the electronic headache diary device) reports: a day with headache pain that lasts at least 4 hours with a peak severity of any severity or; a day when the participant used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages were derived and normalized to 28 days equivalent by the following formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in the e-diary over the relevant period) * 28. The change was calculated as post-baseline value - baseline value.|Baseline (Day -28 to Day -1), Month 12|FAS: all participants who received at least 1 dose of fremanezumab, and had at least 10 days of efficacy assessments by electronic diary after first injection for this study. Data for this outcome was collected and reported separately for CM and EM participants. ‘Overall number of participants analyzed' = participants evaluable for this outcome.|||days/month||Standard Deviation|Mean
2562506|NCT02638103|Other Pre-specified|Change From Baseline in Monthly Average Number of Migraine Days During the 4-Week Period at Month 12|A migraine day was defined as when at least 1 of the following situations occurred: A calendar day(0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for migraine with or without aura; a calendar day(0:00 to 23:59) demonstrating at least 4 consecutive hours (for CM participants) or at least 2 consecutive hours (for EM participants) of a headache meeting criteria for probable migraine, a migraine subtype where only 1 migraine criterion was missing; a calendar day(0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over relevant period/number of days with assessments recorded in e-diary over relevant period)*28. Change was calculated as post-baseline value - baseline value.|Baseline (Day -28 to Day -1), Month 12|Full analysis set (FAS):all participants who received at least 1 dose of fremanezumab, had at least 10 days of efficacy assessments by e-diary after first injection for this study. Data for this outcome was collected and reported separately for CM and EM participants.‘Overall number of participants analyzed'=participants evaluable for this outcome.|||days/month||Standard Deviation|Mean
2562507|NCT02638103|Primary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE was defined as inability to carry out usual activities. Treatment-related AEs were defined as AEs with possible, probable, definite, or missing relationship to study drug. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline (Day 0) up to follow-up visit (Day 533)|Safety population included all participants who received at least 1 dose of fremanezumab.|||Participants|||Count of Participants
2562510|NCT02638051|Primary|Objective Response Rate (ORR)|"Objective Response Rate (ORR) = Complete Remission (CR) + Partial Remission (PR)~WHO criteria of therapeutic effect evaluation at malignant ascites:~Complete Remission (CR): complete absorption of ascites with no obvious regeneration for more than 1 month.~Partial Remission (PR): more than 50% reduction of ascites, with obvious relief of abdominal distention, with maintenance of less than moderate volume of ascites under ultrasound detection for more than 1 month.~No Change (NC): less than 50% reduction of ascites, or no obvious reduction of ascites under ultrasound detection, or even increase of ascites, with obvious abdominal distention."|8 weeks after start of treatment (4 weeks on completion of treatment)||||percentage of participants|||Number
2562511|NCT02637999|Secondary|Number of Participants With Covalently Closed Circular Deoxyribonucleic Acid (cccDNA) Response at Week 72 of Therapy|Virological cccDNA response was defined as reduction of intrahepatic cccDNA by 0.5 log in comparison to baseline at the end of follow up.|Baseline and 72 weeks for arm A and 48 weeks for arms B and C|No data to be reported due to absence of biopsy data. Biopsy data are unavailable because analyses were not performed||||||
2562512|NCT02637999|Secondary|Number of Participants With Biochemical Response at Week 24 of Therapy|Biochemical response was defined as normalization of ALT level as compared to baseline.|Baseline and 24 weeks|For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.|||Participants|||Count of Participants
2562513|NCT02637999|Secondary|Number of Participants With Biochemical Response at Week 12 of Therapy|Biochemical response was defined as normalization of ALT level as compared to baseline.|Baseline and 12 weeks|For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.|||Participants|||Count of Participants
2562514|NCT02637999|Secondary|Number of Participants With Hepatitis D Virus Ribonucleic Acid (HDV RNA) Response at Week 24 of Therapy|HDV RNA response was defined as persistent reduction of HDV RNA by > 1 log IU/mL or negativation (including the patient with negative baseline level)|Baseline and 24 weeks|For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.|||Participants|||Count of Participants
2562515|NCT02637999|Secondary|Number of Participants With Hepatitis D Virus Ribonucleic Acid (HDV RNA) Response at Week 12 of Therapy|HDV RNA response was defined as persistent reduction of HDV RNA by > 1 log IU/mL or negativation (including the patient with negative baseline level)|Baseline and 12 weeks|For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.|||Participants|||Count of Participants
2562516|NCT02637999|Secondary|Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 12 of Therapy|HBV DNA response was defined as persistent reduction of HBV DNA by > 1 log IU/mL or negativation (including the patient with negative baseline level)|Baseline and 12 weeks|For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.|||Participants|||Count of Participants
2562517|NCT02637999|Secondary|Number of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Response at Week 24 of Therapy|HBV DNA response was defined as persistent reduction of HBV DNA by > 1 log IU/mL or negativation (including the patient with negative baseline level)|Baseline and 24 weeks||||Participants|||Count of Participants
2562518|NCT02637999|Secondary|Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 24 of Therapy|HBsAg response was defined as serum HBsAg decline of at least 0.5 log IU/mL (or HBsAg negativation) at week 24 compared to baseline (including the patient with negative baseline level)|Baseline and 24 weeks|For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.|||Participants|||Count of Participants
2562519|NCT02637999|Primary|Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 12 of Therapy|HBsAg response was defined as serum HBsAg decline of at least 0.5 log IU/mL (or HBsAg negativation) at week 12 compared to baseline (including the patient with negative baseline level)|Baseline and 12 weeks|For the efficacy assessments the main analysis set was Full analysis set (FAS): All patients of the Safety set.|||Participants|||Count of Participants
2562520|NCT02637804|Secondary|Papillary Conjunctivitis|Papillary conjunctivitis for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week||||Eyes|Eyes||Number
2562521|NCT02637804|Secondary|Corneal Oedema|Corneal oedema for for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week||||Eyes|Eyes||Number
2562522|NCT02637804|Secondary|Conjunctival Staining|Conjunctival staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week||||Eyes|Eyes||Number
2562523|NCT02637804|Secondary|Corneal Neovascularization|Corneal neovascularization for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week||||Eyes|Eyes||Number
2562524|NCT02637804|Secondary|Corneal Staining|Corneal staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week||||Eyes|Eyes||Number
2562525|NCT02637804|Secondary|Limbal Redness|Limbal redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week||||Eyes|Eyes||Number
2562526|NCT02637804|Secondary|Conjunctival Redness|Conjunctival redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)|1 week||||Eyes|Eyes||Number
2562527|NCT02637804|Secondary|Lens Fit Overall|Lens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Optimum, Good, Acceptable, Not acceptable (cannot wear))|1 week||||Eyes|Eyes||Number
2562528|NCT02637804|Secondary|Lens Fit Overall|Lens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Optimum, Good, Acceptable, Not acceptable (cannot wear))|Baseline||||Eyes|Eyes||Number
2562529|NCT02637804|Secondary|Lens Fit - Post-blink Movement|Lens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Tight, Little tight, Optimal, Little loose, Loose)|1 week||||Eyes|Eyes||Number
2562530|NCT02637804|Secondary|Lens Fit - Post-blink Movement|Lens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose)|Baseline||||Eyes|Eyes||Number
2562531|NCT02637804|Secondary|Lens Fit - Vertical Centration|Lens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Upper, Little upper, Centered, Little lower, Lower)|1 week||||Eyes|Eyes||Number
2562532|NCT02637804|Secondary|Lens Fit - Vertical Centration|Lens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Upper, Little upper, Centered, Little lower, Lower)|Baseline||||Eyes|Eyes||Number
2562533|NCT02637804|Secondary|Lens Fit - Horizontal Centration|Lens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Temporal, Little temporal, Centered, Little nasal, Nasal)|1 week||||Eyes|Eyes||Number
2562534|NCT02637804|Secondary|Lens Fit - Horizontal Centration|Lens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal)|Baseline||||Eyes|Eyes||Number
2562535|NCT02637804|Primary|Lens Preference - Stenfilcon A/Delefilcon A (Group 2)|Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer delefilcon A, prefer delefilcon A).|1 week||||Participants|||Count of Participants
2562536|NCT02637804|Primary|Lens Preference - Stenfilcon A/Narafilcon A (Group 1)|Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer narafilcon A, prefer narafilcon A).|1 week||||Participants|||Count of Participants
2562537|NCT02637804|Primary|Handling|Subjective ratings of handling (lens insertion and lens removal) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor handling, 10=very good handling.|1 week||||units on a scale||Standard Deviation|Mean
2562538|NCT02637804|Primary|Vision|Subjective ratings of vision (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor vision, 10=very good vision).|1 week||||units on a scale||Standard Deviation|Mean
2562539|NCT02637804|Primary|Comfort|Subjective ratings of comfort (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor comfort, 10=very good comfort).|1 week||||units on a scale||Standard Deviation|Mean
2562540|NCT02637804|Primary|Dryness|Subjective ratings of dryness (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very dry, 10=no dryness at all.|1 week||||units on a scale||Standard Deviation|Mean
2562541|NCT02637804|Primary|Red Eye Sensation|Subjective ratings of red eye sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation|1 week||||Eyes|Eyes||Number
2562542|NCT02637804|Primary|Itching Sensation on Removal|Subjective ratings of itching sensation on insertion for each lens pair assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation|1 week||||Eyes|Eyes||Number
2562543|NCT02637804|Primary|Pain and Foreign Body Sensation|Subjective ratings of pain and foreign body sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation|1 week||||eyes|Eyes||Number
2562544|NCT02637557|Secondary|Change From Baseline in the Proportion of Heartburn-Free Days During Week 4|"A heartburn free day was a day where DHSS = 0. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( Heartburn, Burning feeling behind breastbone or in the center of the upper stomach, and Pain behind breastbone or in the center of the upper stomach,) from a particular day."|Week 4|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at treatment week.|||proportion of days||Standard Error|Least Squares Mean
2562545|NCT02637557|Secondary|Change From Baseline in the Proportion of Heartburn-Free Days During Week 8|"A heartburn free day was a day where DHSS = 0. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( Heartburn, Burning feeling behind breastbone or in the center of the upper stomach, and Pain behind breastbone or in the center of the upper stomach,) from a particular day."|Week 8|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at treatment week.|||proportion of days||Standard Error|Least Squares Mean
2562546|NCT02637557|Secondary|Change From Baseline Over Time in the mRESQ-eD Item 'Burping Frequency'|The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their burping over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.|Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.|||units on a scale||Standard Error|Least Squares Mean
2562614|NCT02636608|Secondary|Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days||From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.|Core population who were prescribed ribavirin|||percentage of days||Standard Deviation|Mean
2562547|NCT02637557|Secondary|Change From Baseline Over Time in the mRESQ-eD Item 'Coughing Frequency'|The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their cough over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.|Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.|||units on a scale||Standard Error|Least Squares Mean
2562548|NCT02637557|Secondary|Change From Baseline Over Time in the mRESQ-eD Item 'Acid or Bitter Taste Frequency'|The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of an acid or bitter taste in the mouth over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.|Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.|||units on a scale||Standard Error|Least Squares Mean
2562549|NCT02637557|Secondary|Change From Baseline Over Time in the mRESQ-eD Item 'Regurgitation Frequency'|The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the frequency of their regurgitation (liquid or food moving upwards towards the throat or mouth) over the past 24 hours on a 5-point scale: 0=Never, 1= Rarely, 2=Sometimes, 3=Often, 4=Very often. Daily scores were averaged each week. A negative change from baseline indicates improvement.|Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.|||units on a scale||Standard Error|Least Squares Mean
2562550|NCT02637557|Secondary|Change From Baseline Over Time in the mRESQ-eD Item 'Cough Severity'|The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their cough over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.|Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.|||units on a scale||Standard Error|Least Squares Mean
2562551|NCT02637557|Secondary|Change From Baseline Over Time in the mRESQ-eD Item 'Hoarseness Severity'|The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their hoarseness over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.|Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.|||units on a scale||Standard Error|Least Squares Mean
2562552|NCT02637557|Secondary|Change From Baseline Over Time in the mRESQ-eD Item 'Difficulty Swallowing Severity'|The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their difficulty swallowing over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.|Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.|||units on a scale||Standard Error|Least Squares Mean
2562553|NCT02637557|Secondary|Change From Baseline Over Time in the mRESQ-eD Item 'Pain Behind Breastbone or Center of Upper Stomach Severity'|The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their pain behind the breastbone or in the center of the upper stomach over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.|Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.|||units on a scale||Standard Error|Least Squares Mean
2562554|NCT02637557|Secondary|Change From Baseline Over Time in the Weekly Average of mRESQ-eD Item 'Burning Feeling Behind Breastbone or Center of Upper Stomach Severity'|The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their burning feeling behind the breastbone or in the center of the upper stomach over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from baseline indicates improvement.|Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.|||units on a scale||Standard Error|Least Squares Mean
2562737|NCT02634606|Primary|Change in LDL Cholesterol Over Time Between the 3 Groups|Mixed-effects regression models will be used to evaluate the change in LDL cholesterol over time between the 3 groups|Baseline and 12 weeks|Randomization was not performed prior to study termination||||||
2562555|NCT02637557|Secondary|Change From Baseline Over Time in the Weekly Average of Modified Reflux Symptom Questionnaire - Electronic Diary (mRESQ-eD) Item 'Heartburn Severity'|The mRESQ-eD questionnaire assesses the severity and frequency of the symptoms participants experience due to reflux disease. Participants were asked to rate the severity of their heartburn over the past 24 hours on a 6-point scale: 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe. Daily scores were averaged each week. A negative change from Baseline indicates improvement.|Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Weeks 1, 2, 3, 4, 5, 6, 7, 8|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.|||units on a scale||Standard Error|Least Squares Mean
2562556|NCT02637557|Secondary|Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 4|"DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( Heartburn, Burning feeling behind breastbone or in the center of the upper stomach, and Pain behind breastbone or in the center of the upper stomach,) from a particular day."|Week 4|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.|||days||Standard Error|Least Squares Mean
2562557|NCT02637557|Secondary|Change From Baseline in the Number of Days Where DHSS Was No More Than Very Mild (≤ 1) During Week 8|"DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( Heartburn, Burning feeling behind breastbone or in the center of the upper stomach, and Pain behind breastbone or in the center of the upper stomach,) from a particular day."|Week 8|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and treatment week.|||days||Standard Error|Least Squares Mean
2562558|NCT02637557|Secondary|Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 4|"DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( Heartburn, Burning feeling behind breastbone or in the center of the upper stomach, and Pain behind breastbone or in the center of the upper stomach,) from a particular day. A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week."|Week 4|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values at both baseline and given treatment week.|||percentage of participants||95% Confidence Interval|Number
2562559|NCT02637557|Secondary|Percentage of Participants With a DHSS of No More Than Very Mild (≤ 1) on Any Day During Week 8|"DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( Heartburn, Burning feeling behind breastbone or in the center of the upper stomach, and Pain behind breastbone or in the center of the upper stomach,) from a particular day. A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week."|Week 8|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values both at baseline and given treatment week.|||percentage of participants||95% Confidence Interval|Number
2562560|NCT02637557|Secondary|Percentage of Participants Who Are Overall Heartburn Responders|An overall heartburn responder is a participant who is a weekly heartburn responder for at least 4 of the 8 treatment weeks and for at least 1 of the final 2 treatment weeks (i.e., Week 7 and Week 8). A weekly heartburn responder is a participant with a decrease of >= 30% from baseline in WHSS (see Outcome Measure 1 for description of WHSS). A participant who reported heartburn severity for less than 4 days during a week was not considered a responder for that week.|Week 8|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment|||percentage of participants||95% Confidence Interval|Number
2562561|NCT02637557|Secondary|Change From Baseline to Week 4 in WHSS|"The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( Heartburn, Burning feeling behind breastbone or in the center of the upper stomach, and Pain behind breastbone or in the center of the upper stomach,) from a particular day. A negative change from Baseline indicates improvement."|Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values both at baseline and during the Treatment Period.|||score on a scale||Standard Error|Least Squares Mean
2562562|NCT02637557|Secondary|Change From Baseline to Week 8 in WHSS|"The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( Heartburn, Burning feeling behind breastbone or in the center of the upper stomach, and Pain behind breastbone or in the center of the upper stomach,) from a particular day. A negative change from Baseline indicates improvement."|Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values both at baseline and during the Treatment Period.|||score on a scale||Standard Error|Least Squares Mean
2562563|NCT02637557|Secondary|Percent Change From Baseline to Week 4 in WHSS|"The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( Heartburn, Burning feeling behind breastbone or in the center of the upper stomach, and Pain behind breastbone or in the center of the upper stomach,) from a particular day. A negative change from Baseline indicates improvement."|Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 4|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values both at baseline and during the Treatment Period.|||percentage change in score||Standard Error|Least Squares Mean
2562564|NCT02637557|Primary|Percent Change From Baseline to Week 8 in Weekly Heartburn Severity Score (WHSS)|"The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( Heartburn, Burning feeling behind breastbone or in the center of the upper stomach, and Pain behind breastbone or in the center of the upper stomach,) from a particular day. A negative change from Baseline indicates improvement."|Baseline (derived from the eDiary daily data collected from 7 days before randomization up to the time of randomization), Week 8|modified Intent-to-Treat Population: all randomized participants who received at least one dose of study treatment with values both at baseline and during the Treatment Period.|||percentage change in score||Standard Error|Least Squares Mean
2562565|NCT02637323|Other Pre-specified|Plasma Pharmacokinetic Parameters for FX006 and TCA IR||Up to 20 Weeks|||||||
2562566|NCT02637323|Secondary|Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort|All baseline (pre-treatment) values and all post-baseline values that are recorded as below LLOQ were set to zero for analysis and were included in the descriptive mean calculations. Values below LLOQ were not included in geometric mean calculations.|Up to 20 Weeks|All patients who received study drug and had at least one post-baseline plasma sample obtained and assayed for drug concentration levels.|||pg/mL||95% Confidence Interval|Geometric Mean
2562567|NCT02637323|Primary|Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid|All baseline (pre-treatment) values and all post-baseline values recorded as below LLOQ (<50 pg/mL) were set to zero. Geometric mean summary statistics were computed on adjusted concentration values. One (1) was added to each concentration value observed. BLQ values for the computation of geometric mean are included in the summary with a value of 1 (0+1).|Up to 20 Weeks|All patients who received study drug and had synovial fluid obtained at the Synovial Fluid Visit and assayed for drug concentration levels.|||pg/mL||95% Confidence Interval|Geometric Mean
2562568|NCT02637141|Secondary|Change From Baseline in Total Celiac Disease GSRS (CeD-GSRS) Score at Week 12|"The CeD-GSRS score is derived from a subset of questions from the GSRS questionnaire, including the diarrhea, indigestion, and abdominal pain domains (a total of 10 questions), which are each assessed on a scale of 1 (no discomfort at all) to 7 (very severe discomfort).~The total CeD-GSRS score is calculated as the sum of the scores of all 10 questions, and ranges from 10 (no discomfort at all) to 70 (very severe discomfort in all celiac syndromes)."|Baseline and 12 weeks|Per protocol 1 population with available data|||units on a scale||Standard Error|Least Squares Mean
2562569|NCT02637141|Secondary|Percent Change From Baseline in Total Weekly Gastrointestinal Symptom Rating Scale (GSRS) Score at Week 12|The GSRS is a 15-question 7-scale questionnaire used to assess 5 dimensions of gastrointestinal syndromes: diarrhea, indigestion, constipation, abdominal pain, and reflux. Questions are scored between 1 (no discomfort at all) and 7 (very severe discomfort). The total GSRS score is calculated as the sum of the scores of all 15 questions, and ranges from 15 (no discomfort at all) to 105 (very severe discomfort in all 5 dimensions of gastrointestinal syndromes).|Baseline and 12 weeks|Per protocol 1 population with available data|||percent change||Standard Error|Least Squares Mean
2562570|NCT02637141|Secondary|Number of Participants With Diarrhoea at Baseline and Week 12|"The Bristol Stool Form Scale (BSFS) is a pictorial aid to help study participants identify the shape and consistency of their bowel movements. Participants were asked to complete this form daily using an electronic diary at the time of each bowel movement. The BSFS categorizes bowel movements into 7 types, from Type 1 (separate hard lumps, like nuts; hard to pass) to Type 7 (watery, no solid pieces, entirely liquid).~Diarrhoea was defined as at least one BSFS score >= 6 for the given week."|Baseline and week 12|Per protocol 1 population|||Participants|||Count of Participants
2562571|NCT02637141|Secondary|Number of Weekly Bowel Movements at Baseline and Week 12|Participants were asked to record every bowel movement during the study using an electronic diary. If no bowel movements were experienced on any given day, the participant was required to document this using the electronic diary.|Baseline and week 12|Per protocol 1 population with available data|||bowel movements per week||Standard Deviation|Mean
2562572|NCT02637141|Secondary|Change From Baseline in Anti-Deamidated Gliadin Peptide (DGP) Antibodies at Week 12|Levels of serum anti-DGP antibodies (immunoglobulin A [IgA] and immunoglobulin G [IgG]) were determined using ELISA immunoassay.|Baseline and week 12|Per protocol 1 population with available data|||kU/L||Standard Error|Least Squares Mean
2562573|NCT02637141|Secondary|Percent Change From Baseline in Anti-Tissue Transglutaminase (tTG) Immunoglobulin A (IgA) Antibodies at Week 12|Levels of anti-tTG IgA antibodies in serum were determined using an enzyme-linked immunosorbent assay (ELISA) immunoassay.|Baseline and week 12|Per protocol 1 population with available data|||percent change||Standard Error|Least Squares Mean
2562574|NCT02637141|Secondary|Number of Participants With Improvement in Marsh Score at Week 12|The Marsh classification system describes the stages of damage in the small intestine as seen under a microscope, with possible values of 0, 1, 2, 3a, 3b, or 3c. A score of 0 (best score) indicates that the intestinal lining is normal and celiac disease highly unlikely, a score of 3c (worst score) indicates increased intraepithelial lymphocytes, increased crypt hyperplasia and complete villi atrophy. Improvement is defined as a lower grade on the Marsh score scale compared to baseline.|Baseline and week 12|The per protocol 1 (PP1) population included randomized participants who received at least 1 dose of study drug, were histologically evaluable (provided a post-treatment biopsy sample) and received gluten challenge for at least 1 week.|||Participants|||Count of Participants
2562575|NCT02637141|Secondary|Percent Change From Baseline in Intraepithelial Lymphocyte Density at Week 12|"Intraepithelial lymphocytes (IELS) are white blood cells interspersed between epithelial cells of the small and large intestine where they function to preserve the integrity of the mucosal barrier by protecting the epithelium against pathogen or immune-induced pathology. Increased intraepithelial lymphocytes is associated with celiac disease.~Small bowel biopsies were performed at baseline and week 12; histological assessments were performed by a blinded central pathologist."|Baseline and week 12|The per protocol 1 (PP1) population included randomized participants who received at least 1 dose of study drug, were histologically evaluable (provided a post-treatment biopsy sample) and received gluten challenge for at least 1 week.|||percent change||Standard Error|Least Squares Mean
2562576|NCT02637141|Primary|Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12|"Attenuation of the effects of gluten exposure was assessed by measuring the percent change from baseline in villous height to crypt depth ratio after 10 weeks of gluten challenge.~Villi are the small fingerlike projections that line the small intestine and promote nutrient absorption and are often shortened in patients with celiac disease. Crypts are grooves between the villi that are often elongated in patients with celiac disease. A decreased VH:CD ratio indicates worsening disease.~Small bowel biopsies were performed at baseline and week 12; histological assessments were performed by a blinded central pathologist."|Baseline and week 12|The per protocol 1 (PP1) population included randomized participants who received at least 1 dose of study drug, were histologically evaluable (provided a post-treatment biopsy sample) and received gluten challenge for at least 1 week.|||percent change||Standard Error|Least Squares Mean
2562577|NCT02637063|Secondary|Self-reported Self-efficacy for Lifestyle Behaviors|Five items assessed participants' confidence to engage in JNC-recommended healthy behaviors using a 5-item response option (1=not at all confident (min), 5=very confident (max)). Mean score is reported, with higher scores indicating higher self-efficacy. The scale showed good reliability (alpha=.79).|Baseline, 12 weeks, 24 weeks||||units on a Likert-type scale||Standard Deviation|Mean
2562578|NCT02637063|Secondary|Self-reported Lifestyle Change Preparation Behaviors|"Participants were asked to self-report on days in the past two weeks in which they engaged in specific behaviors to prepare for or support healthy eating and physical activity (i.e., preparation behaviors). The scale comprised 15 items (e.g., thought about what you might do to try to lose weight) assessed on a 5-point scale (1=none (min), 5=12-14 days (max)). Mean score is reported, with higher scores indicating more frequent preparation behaviors. The scale showed good reliability (alpha=.91)."|Baseline, 12 weeks, 24 weeks||||units on a Likert scale||Standard Deviation|Mean
2562579|NCT02637063|Primary|Heart-unhealthy Dietary Intake (Self-reported Number of Fat Servings, Red Meat Servings, Dairy Fat Servings)|Participants were asked about their diet during the past month, using DASH-diet related items adapted from several validated food frequency questionnaires. Participants reported on servings consumed (e.g., never, 1-3 times last month, up to 5 or more times a day) of the following foods: fruits, vegetables, dairy, fats and meat. Number of servings was computed for heart-unhealthy foods (red, processed and high-fat prepared meats).|Baseline, 12 weeks, 24 weeks||||Servings||Standard Deviation|Mean
2562580|NCT02637063|Primary|Heart-healthy Dietary Intake (Number of Fruit/Vegetable Servings, White Meat Servings, Low-fat Dairy Servings)|Participants were asked about their diet during the past month, using DASH-diet related items adapted from several validated food frequency questionnaires. Participants reported on servings consumed (e.g., never, 1-3 times last month, up to 5 or more times a day) of the following foods: fruits, vegetables, dairy, fats and meat. Number of servings was computed for heart-healthy foods (fruits, vegetables and lean meats).|Baseline, 12 weeks, 24 weeks||||Servings||Standard Deviation|Mean
2562581|NCT02637063|Primary|Body Weight|Body weight measurements were taken by participants using a validated, WIFI-enabled weight scale manufactured by BlipCare and provided to study subjects prior to the baseline assessment. Measurements were automatically uploaded over a WIFI connection to the BlipHub app and study outcomes database. Participants were instructed to take weight measurements at the same time of day each time, preferably first thing in the morning after using the bathroom and before eating or drinking. The weight measurement taken on the date and time closest to the completion date and time of each individual's online survey for that assessment point was analyzed. If no measurements were available within two weeks on either side of that date, weight measurements were considered missing for that assessment period.|Baseline, 12 weeks, 24 weeks||||Pounds||Standard Deviation|Mean
2562582|NCT02637063|Primary|Diastolic Blood Pressure|Blood pressure measurements were taken by participants using a validated, WIFI-enabled blood pressure cuff manufactured by BlipCare and provided to study subjects prior to the baseline assessment. Measurements were automatically uploaded over a WIFI connection to the BlipHub app and study outcomes database. Participants followed a standardized measurement protocol based on the American Heart Association protocol for home blood pressure measurement, involving three consecutive measurements, taken one minute apart after a five-minute seated resting period. Measurements were not observed.|Baseline, 12 weeks, 24 weeks||||mm Hg||Standard Deviation|Mean
2562583|NCT02637063|Primary|Systolic Blood Pressure|Blood pressure measurements were taken by participants using a validated, WIFI-enabled blood pressure cuff manufactured by BlipCare and provided to study subjects prior to the baseline assessment. Measurements were automatically uploaded over a WIFI connection to the BlipHub app and study outcomes database. Participants followed a standardized measurement protocol based on the American Heart Association protocol for home blood pressure measurement, involving three consecutive measurements, taken one minute apart after a five-minute seated resting period. Measurements were not observed.|Baseline, 12 weeks, 24 weeks||||mm Hg||Standard Deviation|Mean
2562584|NCT02637037|Secondary|Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration [Vz/F]|To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states.|Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period|PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data.|||L||Standard Deviation|Mean
2562585|NCT02637037|Secondary|Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC [CL/F]|To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states.|Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period|PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data.|||L/h||Standard Deviation|Mean
2562615|NCT02636608|Secondary|Percentage of Participants With Adherence to Ribavirin by Adherence Category|"Adherence to ribavirin is expressed as a percentage of the target dose, and was calculated as:~Cumulative dose taken / (initial prescribed dose * planned duration) * 100"|From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen|Core population who were prescribed ribavirin|||percentage of participants|||Number
2562586|NCT02637037|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve [t½λz]|To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states.|Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period|PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data.|||Hour (h)||Standard Deviation|Mean
2562587|NCT02637037|Secondary|Time to Reach Maximum Plasma Concentration (t Max)|To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states.|Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period|PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data.|||Hour||Full Range|Median
2562588|NCT02637037|Primary|Observed Maximum Plasma Concentration [Cmax] Under Fasted or Fed State|To evaluate the Bioequivalence for Dapagliflozin and Metformin following administration Dapagliflozin/Metformin XR 5/500 mg and 10/1000 mg Manufactured at Mt. Vernon plant, US, Compared to Humacao plant, Puerto Rico, in the Fasted or Fed state|Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period|PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2562589|NCT02637037|Primary|AUC From Time Zero to Time of Last Quantifiable Concentration [AUC (0-t)] Under Fasted or Fed State.|To evaluate the Bioequivalence for Dapagliflozin and Metformin following administration Dapagliflozin/Metformin XR 5/500 mg and 10/1000 mg Manufactured at Mt. Vernon plant, US, Compared to Humacao plant, Puerto Rico, in the Fasted or Fed state|Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period|PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2562590|NCT02637037|Primary|Area Under Plasma Concentration-time Curve [AUC] Under Fasted or Fed State|To evaluate the Bioequivalence for Dapagliflozin and Metformin following administration Dapagliflozin/Metformin XR 5/500 mg and 10/1000 mg Manufactured at Mt. Vernon plant, US, Compared to Humacao plant, Puerto Rico, in the Fasted or Fed state.|Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period|PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2562591|NCT02636907|Secondary|Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Drug-related Adverse Events as Per Investigator Assessment|The percentage of patients with drug-related adverse events as per investigator in the Autoinjector assessment period and Extension Phase. In Extension phase, Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first dose of trial medication and prior to the last date of trial medication during Extension phase treatment period + 10 weeks (70 days) inclusive. The Extension phase treatment period started on the first PFS administration date (Day 57 visit) and ended on Day 351 visit date (included). Thus If a TEAE occurred from the first PFS administration and after the 10 weeks of the last dose during the extension phase, it was to be accounted for in the Extension phase treatment period.|up to Week 60|Safety Analysis Set (SAF): The SAF contained all patients in the all subjects enrolled set (ENR) who received at least 1 dose of trial drug or attempted to inject it as indicated by the questionnaire on self-injection with autoinjector.|||Percentage of participants|||Number
2562592|NCT02636907|Secondary|Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Local Injection Site Reactions|The percentage of patients with local injection site reactions in the Autoinjector assessment period and Extension Phase. In Extension phase, patients were given diaries to record events between each site visit during extension phase. Patients were instructed to accurately record the following on the diary cards: the dates & times of BI 695501 dosing; problems encountered with dosing; the occurrence of any AEs; the use of concomitant therapies; and the PFS storage conditions. Patients were instructed to contact the site if they experienced any AEs between designated site visits. In Extension phase Data is reported as Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first PFS administration date (Day 57 visit) and after the 10 weeks of the last dose during the extension phase, it was to be accounted for in the Extension phase treatment period. Percentage of subjects calculated relative to the total number of subjects in the analysis set|up to Week 60|Safety Analysis Set (SAF): The SAF contained all patients in the all subjects enrolled set (ENR) who received at least 1 dose of trial drug or attempted to inject it as indicated by the questionnaire on self-injection with autoinjector.|||Percentage of participants|||Number
2562593|NCT02636907|Secondary|Autoinjector Assessment Period: The Percentage of Patients With Drug-related Adverse Events Per Investigator Assessment|A treatment-related TEAE was defined as any TEAE assessed by the investigator as related to the trial medication. Data is reported for the autoinjector assessment period. TEAEs were defined as AEs that started or worsened on or after the first dose of trial medication during the treatment period and prior to the last date of trial medication during treatment period + 10 weeks (70 days) inclusive. The autoinjector assessment period started on the first autoinjector administration date (Day 1 visit) and ended on Day 50 visit date (included). If a TEAE occurred in the 10 weeks after the last autoinjector administration but prior to the first injection during the extension phase, it was to be accounted for in the autoinjector assessment period.|Up to 17 weeks.|Safety Analysis Set (SAF): The SAF contained all patients in the all subjects enrolled set (ENR) who received at least 1 dose of trial drug or attempted to inject it as indicated by the questionnaire on self-injection with autoinjector.|||Percentage of participants|||Number
2562594|NCT02636907|Secondary|Autoinjector Assessment Period: The Percentage of Patients With Local Injection Site Reactions|"Qualified trial site personnel contacted the patient 48 hours after each self-injection during the autoinjector assessment period to collect all Adverse Events (AEs), including injection-site reactions. Data is reported as Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first dose of trial medication during the treatment period and prior to the last date of trial medication during treatment period + 10 weeks (70 days) inclusive. The autoinjector assessment period started on the first autoinjector administration date (Day 1 visit) and ended on Day 50 visit date (included). If a TEAE occurred in the 10 weeks after the last autoinjector administration but prior to the first injection during the extension phase, it was to be accounted for in the autoinjector assessment period.~Percentage of subjects calculated relative to the total number of subjects in the analysis set."|Up to 17 weeks.|Safety Analysis Set (SAF): The SAF contained all patients in the all subjects enrolled set (ENR) who received at least 1 dose of trial drug or attempted to inject it as indicated by the questionnaire on self-injection with autoinjector.|||Percentage of participants|||Number
2562595|NCT02636907|Secondary|Autoinjector Assessment Period: Percentage of Any Autoinjector Handling Events|"The percentage of any autoinjector handling event during the self-injection process included any one of the following events which prevented the patient from successfully self-injecting the full content of the autoinjector and which occurred after the training self-injection up to the EoT Visit: removing the cap of the autoinjector (3a); pressing the injection button of the autoinjector (3b); or holding the autoinjector down against the skin until the injection is completed (3c).~Percentage of injections was calculated relative to the total number of injections (both unsuccessful and successful)."|Up to Day 50.|Safety Analysis Set (SAF): The SAF contained all patients in the all subjects enrolled set (ENR) who received at least 1 dose of trial drug or attempted to inject it as indicated by the questionnaire on self-injection with autoinjector.|||Percentage of injections|||Number
2562596|NCT02636907|Primary|Autoinjector Assessment Period: Percentage of Successful Self-injections as Reported in the Questionnaires Completed by Both the Trial Site Personnel and the Patient Analysing All Self-injections|"The percentage of successful self-injections as reported in the questionnaires completed by both the trial site personnel and the patient during the Autoinjector Assessment Period analyzing all self-injections occurring after the training self-injection up to the EoT Visit. Successful self-injections were based on the response to Question 2 (Q2) on the questionnaire, which queried whether the full content of the autoinjector was injected into the body. An injection was considered successful when both the patient and the qualified trial site personnel responded yes to the Q2 on their respective questionnaires. If they responded no to Q2, patients and trial site personnel were instructed to also answer Question 3, which asked what prevented the patient for injecting the full contents of the autoinjector. Planned injections after discontinuation from the trial were not included in the analysis.~Percentage of injections calculated relative to the total number of first injections."|Up to Day 50.|Safety Analysis Set (SAF): The SAF contained all patients in the all subjects enrolled set (ENR) who received at least 1 dose of trial drug or attempted to inject it as indicated by the questionnaire on self-injection with autoinjector.|||Percentage of injections||95% Confidence Interval|Number
2562597|NCT02636712|Secondary|Percentage of Participants Without System-related Complications|No one has any complications related system occurred. So Complication-Free rate is 100%.|Within 3 months after the Pacemaker been implanted.||||percentage of paticipants||95% Confidence Interval|Number
2562598|NCT02636712|Primary|Percentage of Participants With Ventricular Sensed Amplitudes at the MRI Visit + 1 Month Follow up Remains ≥ 5.0 mV and Above 50% of the Pre-MR Scan.|The percentage of participants with ventricular sensed amplitudes at the MRI Visit + 1 Month Follow up remains ≥ 5.0 mV and above 50% of the pre-MR scan is 100%.|Pre-MR scan and 1 Month post-MR Scan.||||percentage of paticipants||95% Confidence Interval|Number
2562599|NCT02636712|Primary|Percentage of Participants With Atrial Sensed Amplitude at the MRI Visit + 1 Month Follow up Remains ≥ 1.0 mV and Above 50% of the Pre-MR Scan Value|The Percentage of participants with atrial sensed amplitude at the MRI Visit + 1 Month Follow up remains ≥ 1.0 mV and above 50% of the pre-MR scan value is 100%.|Pre-MR scan and 1 Month post-MR Scan.||||percentage of paticipants||95% Confidence Interval|Number
2562600|NCT02636712|Primary|Percentage of Participants Reporting an Increase in Pacing Thresholds ≤ 0.5V (at 0.5 ms) From Pre-MR Scan to MRI Visit + 1 Month Follow-up|The percentage of Participants Reporting an Increase in Pacing Thresholds ≤ 0.5V (at 0.5 ms) from Pre-MR Scan to MRI Visit + 1 Month Follow-up is 100 percent.|Pre-MR scan and 1 Month post-MR Scan.||||percentage of participants||95% Confidence Interval|Number
2562601|NCT02636712|Primary|Percentage of Participants Without Complications at MRI Visit + 1 Month.|No one has any complications related MR Scan . So Complication-Free rate is 100%.|Within 1 month after the Pacemaker been implanted.||||percentage of paticipants||95% Confidence Interval|Number
2562602|NCT02636608|Secondary|Satisfaction With the AbbVie Patient Support Program (PSP) Components|At the end of treatment visit participants were asked to indicate their level of satisfaction with each of the PSP services they had used.|End of treatment (weeks 12 or 24 depending on treatment regimen)|Core population who participated in the PSP with available data|||Participants|||Count of Participants
2562603|NCT02636608|Secondary|Utilization of the AbbVie Patient Support Program (PSP) Components|"At the end of treatment visit participants were asked to indicate which of the following PSP services they had used:~Personal support (e.g., Care Coach)~Printed educational material~Online educational materials~Web-portal~App"|End of treatment (week 12 or 24 depending on the treatment regimen)|Core population who participated in the PSP|||Participants|||Count of Participants
2562604|NCT02636608|Secondary|Number of Participants Who Participated in the AbbVie Patient Support Program (PSP)||Up to post treatment week 24|Core population|||Participants|||Count of Participants
2562616|NCT02636608|Secondary|Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category|"Adherence to the ABBVIE treatment regimen is expressed as a percentage of the target dose and was calculated as:~Cumulative dose taken / (initial prescribed dose * planned duration) * 100~The ABBVIE regimen consists of paritaprevir/r and ombitasvir with or without dasabuvir."|From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen.|Core population|||percentage of participants|||Number
2562605|NCT02636608|Secondary|Change From Baseline in Patient Activation Measure 13 (PAM-13)|"PAM-13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. Each of the 13 items can be answered with one of four possible response options, which are disagree strongly (1), disagree (2), agree (3), agree strongly (4). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating that the participant is likely to participate more actively in health care processes and takes more responsibility for his or her health."|Baseline and end of treatment (week 12 or 24 depending on the treatment regimen)|The Core population with available data at baseline and end of treatment.|||units on a scale||95% Confidence Interval|Least Squares Mean
2562606|NCT02636608|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment|"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems."|Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|The Core population with available data at baseline and each time point.|||percent impairment||Standard Deviation|Mean
2562607|NCT02636608|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)|"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total work productivity impairment (TWP) indicates the percentage of overall work impairment due to health problems."|Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|The Core population who were employed and with available data at baseline and each time point.|||percent impairment||Standard Deviation|Mean
2562608|NCT02636608|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism|"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Presenteeism indicates the percentage of impairment while working due to health problems."|Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|The Core population who were employed and with available data at baseline and each time point.|||percent impairment||Standard Deviation|Mean
2562609|NCT02636608|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism|"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Absenteeism indicates the percentage of work time missed due to health problems."|Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|The Core population who were employed and with available data at baseline and each time point.|||percent impairment||Standard Deviation|Mean
2562610|NCT02636608|Secondary|Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score|"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS).~Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status."|Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|Core population with available data at baseline and each time point.|||units on a scale||95% Confidence Interval|Least Squares Mean
2562611|NCT02636608|Secondary|Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score|"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS).~The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable). The higher the score the better the health status."|Baseline, end of treatment (week 12 or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|Core population with available data at baseline and each time point.|||units on a scale||95% Confidence Interval|Least Squares Mean
2562612|NCT02636608|Secondary|Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies||From first dose of study drug through 30 days after last dose (16 or 28 weeks depending on the treatment regimen)|All treated participants|||Participants|||Count of Participants
2562613|NCT02636608|Secondary|Number of Participants Who Received Concomitant Medications|Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir until after the last dose.|From first dose of study drug to end of treatment, 12 to 24 weeks depending on the treatment regimen|All treated participants|||Participants|||Count of Participants
2562617|NCT02636608|Secondary|Percentage of Participants in Each Non-response Category 12 Weeks Post-treatment|"SVR12 non-response was categorized according to the following:~On-treatment virologic failure (breakthrough [at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥ 50 IU/mL]);~Relapse, defined as HCV RNA < 50 IU/mL at EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened);~Death;~Premature treatment discontinuation with no on-treatment virologic failure;~None of the above criteria or missing SVR12 data"|12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)|The Core population|||Participants|||Count of Participants
2562618|NCT02636608|Secondary|Number of Participants With Breakthrough|Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.|12 or 24 weeks (depending on the treatment regimen)|The Core population with at least one documented HCV RNA < 50 IU/mL while on treatment and at least one on-treatment or EOT measurement thereafter.|||Participants|||Count of Participants
2562619|NCT02636608|Secondary|Percentage of Participants With Relapse|Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.|End of treatment (week 12 or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.|The Core population with VR at EOT, who completed treatment, and had ≥ 1 HCV RNA measurement ≥ 70 days post-treatment or were a treatment failure between EOT and day 70.|||percentage of participants||95% Confidence Interval|Number
2562620|NCT02636608|Secondary|Percentage of Participants Achieving Virological Response at End of Treatment|Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.|End of treatment (week 12 or 24 depending on the treatment regimen)|The Core population defined as enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants||95% Confidence Interval|Number
2562621|NCT02636608|Secondary|Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24)|"Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug.~The Core population with sufficient follow-up data regarding SVR24 included all core population participants who~had evaluable HCV RNA data ≥ 126 days after the last actual dose of the ABBVIE REGIMEN~or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline~or had HCV RNA < 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 126 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure."|24 weeks after the last dose of study drug (week 36 or 48 depending on the treatment regimen)|The Core population with sufficient follow-up data regarding SVR24|||percentage of participants||95% Confidence Interval|Number
2562622|NCT02636608|Primary|Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)|Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure.|12 weeks after the last dose of study drug (week 24 or 36 depending on the treatment regimen)|The Core population, defined as enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants||95% Confidence Interval|Number
2562623|NCT02636595|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
2562624|NCT02636595|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Treatment weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
2562625|NCT02636595|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2562626|NCT02636283|Secondary|Quality of Life Questionnaires|Questionnaires describing independent living and quality of life|12 weeks|Study terminated prematurely; outcome measure data was not collected.||||||
2562627|NCT02636283|Secondary|Arterial Elasticity|Pulse wave pressure analysis|12 weeks|Study terminated prematurely; outcome measure data was not collected.||||||
2562628|NCT02636283|Secondary|Insulin Sensitivity|Using Homeostasis Model Assessment (HOMA) index|12 weeks|Study terminated prematurely; outcome measure data was not collected.||||||
2562629|NCT02636283|Secondary|Mitochondrial and Microvascular Function Arterial Elasticity|Post-contraction measures of mitochondrial and microvascular function using MR spectroscopy and functional MRI|12 weeks|Study terminated prematurely; outcome measure data was not collected.||||||
2562630|NCT02636283|Primary|Treadmill Walk Until Pain Initiated in Minutes|Time in minutes on a standardized treadmill test to initiation of pain and time until pain requires patient to stop walking|12 weeks|Study terminated prematurely; outcome measure data was not collected.||||||
2562631|NCT02636049|Secondary|Incidence of Treatment Emergent Serious Adverse Events|The number of patients that experienced treatment emergent serious adverse events (TESEAs) will be quantified.|10 - 14 days|Safety Population: all enrolled subjects|||participants|||Number
2562633|NCT02636049|Primary|Pharmacokinetics of Triferic Iron Administered IV to Healthy Adults: Area Under the Serum Iron Concentration Time Curve From Time Zero to the Time of Last Quantified Concentration (AUC(Last)) of Total Serum Iron|Blood samples will be drawn at time = 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, and 16 hours after the start of Triferic administration on study Day 2 (IV infusion of 6 mg Triferic over 3 hours) and study day 3 (35 microgram/kg IV Triferic dose administered in 30 - 60 seconds) in order to determine the AUC(last) of total serum iron.|16 hours|Pharmacokinetic population: all enrolled subjects who received at least 1 dose of study drug and had sufficient pharmacokinetic samples (a sample at the end of infusion and at least 3 samples during the elimination phase) for analysis.|||hour*microgram/deciliter||Geometric Coefficient of Variation|Geometric Mean
2562634|NCT02636049|Primary|Pharmacokinetics of Triferic Iron Administered IV to Healthy Adults: Maximum Drug Concentration (Cmax) of Total Serum Iron|Blood samples will be drawn at time = 0, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12, and 16 hours after the start of Triferic administration on study Day 2 (IV infusion of 6 mg Triferic over 3 hours) and Day 3 (35 microgram/kg IV dose of Triferic given over 30 - 60 seconds) in order to determine the Peak Serum Concentration, corrected (Cmax) of total serum iron.|16 hours|Pharmacokinetic population: all enrolled subjects who received at least 1 dose of study drug and had sufficient pharmacokinetic samples (a sample at the end of infusion and at least 3 samples during the elimination phase) for analysis.|||microgram/deciliter||Geometric Coefficient of Variation|Geometric Mean
2562635|NCT02635984|Secondary|Percent of Patients With Complete Response in Delayed Phase|Complete response (no emesis and no more than minimal nausea, defined as < 25 mm on a 100 mm visual analog scale [VAS]) in delayed phase (5 days after chemotherapy)|Until study completion; estimated 1.5 years||||Participants|||Count of Participants
2562636|NCT02635984|Secondary|Percent of Patients With Complete Response in Acute Phase|Complete response (no emesis and no more than minimal nausea, defined as < 25 mm on a 100 mm visual analog scale [VAS]) in acute phase (days of chemotherapy)|Until study completion; estimated 1.5 years||||Participants|||Count of Participants
2562637|NCT02635984|Secondary|Percent of Patients With no Nausea in Overall Assessment Period|No nausea (all VAS <5 mm) in overall assessment period (days of chemotherapy plus five days after)|Until study completion; estimated 1.5 years||||Participants|||Count of Participants
2562638|NCT02635984|Secondary|Percent of Participants With no Significant Nausea in Delayed Phase|Reported for delayed [5 days after chemotherapy administration] All assessment with all VAS < 25 mm|Until study completion; estimated 1.5 years||||Participants|||Count of Participants
2562639|NCT02635984|Secondary|Percent of Participants With no Significant Nausea in Acute Phase|Reported as acute [chemotherapy days]. All assessment with all VAS < 25 mm on days of chemotherapy|Until study completion; estimated 1.5 years||||Participants|||Count of Participants
2562640|NCT02635984|Secondary|Percent of Patients Achieving Complete Protection in Overall Assessment Phase|(CP = no emesis, no breakthrough antiemetic use, no significant nausea). To be reported as overall phases [chemotherapy days plus 5 days after]|Until study completion; estimated 1.5 years||||Participants|||Count of Participants
2562641|NCT02635984|Secondary|Percent of Patients With no Significant Nausea in Overall Assessment Period|Reported for overall phases [chemotherapy days plus 5 days after] where all VAS < 25 mm|Until study completion; estimated 1.5 years||||Participants|||Count of Participants
2562642|NCT02635984|Primary|Overall Percentage of Patients Who Had a Complete Response|Overall percentage of patients who had a complete response (CR) defined as no emesis and minimal nausea (< 25 mm on a 100 mm visual analog scale [VAS]) during the overall assessment period (starting day 1 of chemotherapy and continuing for 5 days after discontinuation of chemotherapy) for the first cycle of chemotherapy.|Until study completion; estimated 1.5 years||||Participants|||Count of Participants
2562643|NCT02635880|Secondary|Percentage of Particpant Satisfaction of Improvement in Treated Lesions by the Subject|Degree of improvement in treated lesions at 6 weeks post-final treatment as assessed by the subject through a customized subject satisfaction survey. Survey was based upon a scoring 0 - Extremely Unsatisfied, 1 - Unsatisfied, 2 - Neutral, 3- Satisfied, 4 - Extremely Satisfied.|6 weeks post-final treatment||||% of participants|||Number
2562644|NCT02635880|Primary|Percentage of Participants With Change of Treated Lesions|Degree of change in treated lesions at 6 weeks post-final treatment as assessed using the Global Aesthetic Improvement Scale (GAIS) with a scoring of 0 - for no change, 1 - Mild Improvement, 2 - Moderate Improvement, 3 - Significant Improvement, 4 - Very SIgnificant Improvement.|Baseline and 6 weeks post-final treatment||||% of participants|||Number
2562645|NCT02635828|Secondary|Incidence of Subjects Significant QTc Changes in the EKG|The incidence of significant QTc prolongation was measured by comparing baseline EKG, 24 hours and 120 hours after surgery|24 and 120 hours/discharge after end of surgery||||participants|||Number
2562646|NCT02635828|Primary|PONV Incidence|The incidence of PONV|24 hours after end of surgery|Incidence of PONV|||participants|||Number
2562647|NCT02635646|Secondary|2h OGTT Glucose|Measurement of 2h post OGTT glucose|6 and 12 months||||mg/dl||Standard Deviation|Mean
2562648|NCT02635646|Secondary|Weight|Weight in the relatives of the patients|12 months||||kg||Standard Deviation|Mean
2562649|NCT02635646|Secondary|Family Insulin Resistance and Insulin Secretion (Matsuda Index Measured in the Relatives of the Patients)|Whole body insulin sensitivity as determined by the Matsuda Index as calculated using the following formula: 10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load. Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher scores indicating better insulin sensitivity (the higher the value the better the result). A value of 2.5 or less is indicative of low insulin sensitivity (worst result).|12 months|Matsuda Index measured in the relatives of the patients at the end of the study (12 months)|||score on a scale||Standard Deviation|Mean
2562678|NCT02634983|Secondary|Regional Ventilated Lung Volume|The regional distribution of inhaled gas within the lung was assessed using an inhaled gaseous contrast agent, Hyperpolarized Helium (3He) Lung Imaging. The Regional Ventilated Lung Volume was expressed in percentage (% VDV) of total lung volume for each lobar region.|Day 8 to Day 10 (each treatment period)|The PD Analysis Set, which consisted of all participants with valid results assessed in each treatment period, was considered.|||Percentage of total lung volume||90% Confidence Interval|Least Squares Mean
2562650|NCT02635646|Primary|Individual Insulin Resistance and Insulin Secretion|Whole body insulin sensitivity as determined by the Matsuda Index was calculated using the following formula: 10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load. Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher values indicating better insulin sensitivity (better result, the higher the value the better the result of this variable). A value of 2.5 or less is indicative of low insulin sensitivity (worst result).|12 months|Only the patients that completed the 12-months follow-up were included in this analysis, since some patients drop-out from the study before the 12-months follow-up.|||score on a scale||Standard Deviation|Mean
2562651|NCT02635646|Primary|Individual Insulin Resistance and Insulin Secretion|Whole body insulin sensitivity as determined by the Matsuda Index was calculated using the following formula: 10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load. Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher scores indicating better insulin sensitivity (better result). A value of 2.5 or less is indicative of low insulin sensitivity (worst result).|6 months|The analysis was performed only in patients completing the 6 month follow-up, since there were patients lost during the follow-up by drop-outs|||score on a scale||Standard Deviation|Mean
2562652|NCT02635542|Secondary|Surgical Conditions|Assessed by surgeon questionnaire designed for study to determine any negative effects impeding the progress of surgery or safety, on scale of 1=poor to 5=excellent|During general anesthesia|2 participants in the CIS group and 4 participants in the SUX group had missing data for this outcome.|||units on a scale||Standard Deviation|Mean
2562653|NCT02635542|Primary|Number of Participants With Postoperative Pulmonary Complications|Having at least one of the following complications, determined according to pre-specified criteria: extubation delayed >24hrs, reintubation, mechanical respiratory support, pneumonia, aspiration, ARDS (Acute Respiratory Distress Syndrome), or mortality from respiratory arrest.|72 hours following surgical procedure||||Participants|||Count of Participants
2562654|NCT02635425|Primary|Number of Participants of Severe Ovarian Hyperstimulation Syndrome||2 weeks||||participants|||Number
2562655|NCT02635347|Secondary|Number of Subjects Not Completing Intervention Protocol|Number of subjects that received fewer than 6 interventions,.|Pre-op - Post-op day 4|Number of subjects who completed < 6 interventions|||participants|||Number
2562656|NCT02635347|Secondary|Patient Survival|Percentage of patients alive at 90 days post-transplant|Post-op day 90||||percentage of participants|||Number
2562657|NCT02635347|Secondary|Liver Allograft Survival|Percentage of patients with functioning allograft at 90 days post-transplant|Post-op day 90|Denominator for this and other postoperative outcomes except death and complications was 30 due to the exclusion of subject who died prior to transplantation|||percentage of participants|||Number
2562658|NCT02635347|Secondary|Hospital LOS|Number of days in hospital post-transplant. Starting at post-op day 0 and ending on the calendar date that the patient is leaves the hospital, dies, or post-op day 90, whichever is soonest.|Post-op days 0 up to 90 days||||days||Inter-Quartile Range|Median
2562659|NCT02635347|Secondary|Intensive Care Unit (ICU) Length of Stay (LOS)|Number of days in ICU post-transplant. Starting at post-op day 0 and ending on the calendar date that the patient is transferred out of ICU, dies, or post-op day 90, whichever is soonest.|Post-op days 0 up to 90 days|Denominator for this and other postoperative outcomes except death and complications was 30 due to the exclusion of subject who died prior to transplantation|||days||Inter-Quartile Range|Median
2562660|NCT02635347|Secondary|Clavien-Dindo Grade IIIb or Higher - Number of Complications|In patients with Clavien-Dindo >/= IIIb complications, number of such complications per patient.|Post-op days 0-30||||Complications||Inter-Quartile Range|Median
2562661|NCT02635347|Secondary|Presence of Clavien-Dindo Grade IIIb or Higher Complications|"Percentage of patients with Clavien-Dindo >/= grade III b complications (Dindo D, Demartines N, Clavien P, Annals of Surgery 2004).~The Clavien-Dindo Complications grade ranges from Grade I (Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside) to Grade V (Death). Grade IIIb would be any intervention requiring general anesthesia."|Post-op days 0-30||||percentage of participants|||Number
2562662|NCT02635347|Secondary|Time to Dialysis Discontinuation|In patients who are receiving dialysis pre-op, time to discontinuation of dialysis, if occurring within 90 days of transplantation.|Post-op days 0-90|Time to discontinuation of dialysis|||days||Inter-Quartile Range|Median
2562663|NCT02635347|Secondary|Percentage of Participants Who Developed Acute Kidney Injury (AKI) Stages 2 or 3|"Percentage of participants who developed Acute Kidney Injury (AKI)~Based on Kidney Disease - Improving Global Outcomes (KDIGO) criteria, AKI criteria are:~Stage 2:~- 2.0-2.9 fold rise in serum creatinine from baseline~Stage 3:~> 3.0 fold rise in serum creatinine from baseline, or~Serum creatinine of > 4.0 mg/dL, with an acute (<48 hours) increase of 0.3 mg/dL in serum creatinine or subacute (< 7 days) increase in serum creatinine of 0.5 mg/dL, or~Initiation of renal replacement therapy."|Post-op days 0-7|Denominator for this and other postoperative outcomes except death and complications was 30 due to the exclusion of subject who died prior to transplantation|||percentage of participants|||Number
2562664|NCT02635347|Secondary|Percentage of Participants Who Developed Prolonged Respiratory Insufficiency (PRI)|"Percentage of Participants who developed Prolonged Respiratory Insufficiency (PRI) defined as:~Ventilator support for >2 postoperative days after transplant, or~Reintubation after extubation, within 7 days of transplant. Patients who require brief re-intubation for an endoscopic, radiologic, or surgical procedure would not be considered to have PRI if they are extubated within 2 days of the end of the procedure."|Post-op days 0-7|Denominator for this and other postoperative outcomes except death and complications was 30 due to the exclusion of subject who died prior to transplantation|||percentage of participants|||Number
2562665|NCT02635347|Secondary|Percentage of Participants Who Developed Early Allograft Dysfunction (EAD)|"Percentage of participants who developed Early Allograft Dysfunction (EAD) which is defined as:~Aspartate Transaminase (AST) or Alanine Transaminase (ALT)> 2,000 U/L at any point within the first seven post-transplant days, or~Total Bilirubin (TB) > 10 mg/dL on postoperative day 7,or~International Normalized Ratio (INR)> 1.6 on postoperative day 7."|Post-op days 0-7|Denominator for this and other postoperative outcomes except death and complications was 30 due to the exclusion of subject who died prior to transplantation|||percentage of participants|||Number
2562666|NCT02635347|Secondary|Withdrawal of Consent Due to Pain|- Withdrawal of consent due to discomfort/pain in the lower extremity|Pre-op - Post-op day 7|Participants who withdrew consent due to pain from RIC intervention.|||participants|||Number
2562667|NCT02635347|Secondary|Intervention-related Pain Score|Median intervention-related pain score during each of the post-operative interventions, in extubated patients who are able to communicate. Using the Numerical Rating Scale (NRS, Ferrieira-Valente MA PAIN Volume 152, 2011), patients were asked to rate their pain following the intervention on a scale of 0-10 with 0 being no pain experienced to 10 as the maximum pain felt.|Post-op days 1-4|Unintubated subjects were asked to rate intervention-related pain on a scale from 0-10 for each of the postoperative interventions. The maximum pain score obtained from each subject was recorded and the median score for all subjects was calculated. Scale range from 0 - 10 with 10 indicating highest sensation of pain.|||scores on a scale||Inter-Quartile Range|Median
2562668|NCT02635347|Primary|Percentage of Participants Completing Entire Intervention Protocol|Proportion of enrolled liver recipients that complete all 6 remote ischemic conditioning (RIC) interventions.|Pre-op - Post-op day 4|Participants enrolled to receive RIC during transplant and the initial four post-transplant days and who receive all 6 RIC interventions.Subjects in historical control cohort chosen as described above|||percentage of participants||95% Confidence Interval|Number
2562669|NCT02635204|Secondary|Percent of Subjects With Treatment Success at Day 8 Visit|Percent of subjects with treatment success at Day 8 Visit defined as an IGA of 0 or 1 with at least a 2 grade reduction from baseline. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.|Baseline and Day 8|Intention to treat population defined as all subjects who were randomized and dispensed medication|||percentage of subject|||Number
2562670|NCT02635204|Secondary|Percent Change From Baseline in Body Surface Area at Day 15|Percent change from baseline in body surface area affected by psoriasis at Day 15. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.|Baseline and Day 15|Intention to treat|||percentage change in body surface area||Standard Deviation|Mean
2562671|NCT02635204|Primary|Percentage of Subjects With Treatment Success at Day 15|The percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2-grade reduction from baseline) at the Day 15 visit. Primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.|Day 15 Visit|Intention to treat population defined as all subjects who were randomized and dispensed medication|||percentage of participants|||Number
2562672|NCT02634983|Secondary|Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)|The diffusing capacity of the lung for carbon monoxide (DLCO) is a measure of how easily carbon monoxide (CO) molecules transfer from the alveolar gas to the hemoglobin of the red cells in the pulmonary circulation. To measure the DLCO, the patient inhales a single breath containing a minute amount of CO and holds it for 10 seconds. The breath is then exhaled and the exhaled breath is analyzed for CO. The change in the concentration of the CO is then multiplied by the single breath TLC to calculate the DLCO.|Day 8 (each treatment period)|The PD Analysis Set, which consisted of all participants with valid results assessed in each treatment period, was considered.|||mL/min/mmHg||90% Confidence Interval|Least Squares Mean
2562673|NCT02634983|Secondary|Lung Clearance Index by Multiple Breath Nitrogen Washout (MBNW)|Multiple Breath Nitrogen Washout (MBNW) was performed after 2 hours post-dose spirometry assessments using a multiple breath inert gas washout technique. The device provides the global index of ventilation inhomogeneity assessment (LCI = Cumulative Expired Volume/Functional Residual Capacity).|Day 8 (each treatment period)|The PD Analysis Set, which consisted of all participants with valid results assessed in each treatment period, was considered.|||Ratio||90% Confidence Interval|Least Squares Mean
2562674|NCT02634983|Secondary|FEV1/FVC Ratio|The FEV1/FVC ratio is the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC). The result of this ratio is expressed as FEV1%.|Day 1 (0.25, 1 and 2 hours post-dose), Day 8 (-0.75, -0.25, 0.25, 1 and 2 hours post-dose) (each treatment period)|The PD Analysis Set, which consisted of all participants with valid results assessed in each treatment period, was considered.|||FEV1 Percentage||90% Confidence Interval|Least Squares Mean
2562675|NCT02634983|Secondary|Forced Vital Capacity (FVC)|Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. An increase in FVC indicates improvement in lung function.|Day 1 (0.25, 1 and 2 hours post-dose), Day 8 (-0.75, -0.25, 0.25, 1 and 2 hours post-dose) (each treatment period)|The PD Analysis Set, which consisted of all participants with valid results assessed in each treatment period, was considered.|||Liter||90% Confidence Interval|Least Squares Mean
2562676|NCT02634983|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|The Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.|Day 1 (0.25, 1 and 2 hours post-dose), Day 8 (-0.75, -0.25, 0.25, 1 and 2 hours post-dose) (each treatment period)|The PD Analysis Set, which consisted of all participants with valid results assessed in each treatment period, was considered.|||Liter||90% Confidence Interval|Least Squares Mean
2562677|NCT02634983|Secondary|Pulmonary Perfusion|Lung Perfusion Imaging, or MR perfusion imaging of the lung with gadolinium contrast agent, was performed to determine whether vascular abnormalities producing perfusion deficits corresponded to abnormalities in ventilation (hypoxic vasoconstriction). Pulmonary Perfusion was expressed in ml/100 g lung tissue/min of each lobar region.|Day 8 to Day 10 (each treatment period)|The PD Analysis Set, which consisted of all participants with valid results assessed in each treatment period, was considered.|||ml/100 g lung tissue/min||90% Confidence Interval|Least Squares Mean
2562738|NCT02634580|Secondary|Percent Change From Baseline in VLDL-C at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562679|NCT02634983|Primary|Global Ventilated Lung Volume|The global distribution of inhaled gas within the lung was assessed using an inhaled gaseous contrast agent, Hyperpolarized Helium (3He) Lung Imaging. The Global Ventilated Lung Volume was expressed in percentage (%VV) of total lung volume.|Day 8 to Day 10 (each treatment period)|The PD Analysis Set, which consisted of all participants with valid results assessed in each treatment period, was considered.|||Percentage of total lung volume||90% Confidence Interval|Least Squares Mean
2562680|NCT02634827|Other Pre-specified|Minimal Residual Disease (MRD) Status, Assessed by PCR for FLT3 Mutation (if FLT3 is Repeated) or Flow Cytometry|MRD status will be correlated with response using Fisher's exact test. In addition, the relationship between MRD status (positive vs. negative) and disease-free survival will be evaluated using landmark analyses.|Up to day 1 of course 9|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2562681|NCT02634827|Other Pre-specified|FLT3 Mutation by ITD vs. TKD vs. Both, Assessed by Polymerase Chain Reaction (PCR), Western Blot, and Flow Cytometry|Prognostic and predictive factors including age and FLT3 mutation by ITD vs. TKD vs. both will be assessed. These factors will be summarized and used to help characterize the types of patients accrued to this trial. In addition, differences in the distributions of these risk factors by clinical outcome will be explored (CR/CRi vs. not, OS and disease-free survival). Nonparametric quantitative comparisons by group will be made as appropriate (Fisher's exact or Wilcoxon rank sum). Kaplan-Meier methods and log rank statistics will be used to compare between groups for time to- event measures.|Up to day 1 of course 9|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2562682|NCT02634827|Secondary|PFS|Estimated using the method of Kaplan-Meier. In addition, the progression-free survival rate at 1 year after registration will be reported.|Time from registration to the time of relapse or death due to any cause, assessed up to 2 years|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2562683|NCT02634827|Secondary|Overall Response Rate, Estimated by the Total Number of Complete or Partial Responses (CR, CRi, Morphologic Leukemia-free State, or PR) Divided by the Total Number of Evaluable Patients|Overall response rate, estimated by the total number of complete or partial responses (CR, CRi, morphologic leukemia-free state, or PR) divided by the total number of evaluable patients Exact binomial 95% confidence intervals for the true overall response rate will be calculated.|Up to 2 years|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2562684|NCT02634827|Secondary|OS|Estimated using the method of Kaplan-Meier. In addition, the overall survival rate at 1 year after registration will be reported.|Time from registration to death due to any cause, assessed up to 2 years|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2562685|NCT02634827|Secondary|Incidence of Adverse Events, Graded According to the NCI CTCAE Version 4.0|The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.|Up to 2 years|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2562686|NCT02634827|Secondary|Duration of Complete Response, Defined for All Evaluable Patients Who Have Achieved a CR or CRi as the Date at Which the Patient's Objective Status is First Noted to be a CR or CRi to the Earliest Date Relapse is Documented|The distribution of duration of complete response will be estimated using the method of Kaplan-Meier. If there are a sufficient number of CR/CRi, a landmark analyses may be performed to compare duration of CR/CRi in patients who first achieved a CR/CRi at 2 months vs those who first achieved a CR/CRi at 8 months.|Up to 2 year|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2562687|NCT02634827|Primary|Proportion of Complete Responses to Therapy, Where a Success is Defined as a CR or CRi as the Objective Status|The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial confidence intervals for the true success proportion will be calculated.|Up to 2 years|Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.||||||
2562688|NCT02634814|Primary|Mean Knee Flexion Angle During Walking Gait Measured in Degrees of Knee Flexion|The peak Knee Flexion Angle was calculated using using inverse dynamics calculations in the first 50% of the stance phase of gait and during self selected gait speed.|8-weeks from Baseline|Difference in baseline individuals and number of participants are due to a proportion of patients lost to follow up and measurable outcomes were unable to be analyzed due to error in positioning of knee joint center marker.|||degrees||Standard Deviation|Mean
2562689|NCT02634814|Primary|Mean Internal Knee Extension Moment During Walking Gait Measured in Nm/ Body Weight*m|The peak internal knee extension moment was calculated using using inverse dynamics calculations in the first 50% of the stance phase of gait and normalized to the Body Weight* height (m) of the individual during self selected gait speed.|8-weeks from Baseline|Difference in baseline individuals and number of participants are due to a proportion of patients lost to follow up and measurable outcomes were unable to be analyzed due to error in positioning of knee joint center marker.|||Nm/ Body Weight *m||Standard Deviation|Mean
2562690|NCT02634814|Primary|Mean Maximal Quadriceps Strength as Measured by the Maximal Isometric Voluntary Contractions Normalized to Body Weight|Quadriceps strength was measured in Newton Meters normalized to body weight of the individuals. Strength was assessed in 90 degrees of knee flexion.|8-weeks from Baseline|Difference in baseline individuals and number of participants are due to a proportion of patients lost to follow up and participants electing not to undergo voluntary quadriceps activation.|||Nm/kg body weight||Standard Deviation|Mean
2562691|NCT02634814|Primary|Mean Voluntary Quadriceps Activation as Measured by the Central Activation Ratio Expressed as a Percent of Full Activation|The investigators assessed voluntary quadriceps central activation ratio as a representative variable of lower extremity neuromuscular activation using the supra imposition technique. Quadriceps central activation ratio has been demonstrated to be significantly decreased in knee osteoarthritis (OA) compared to healthy, matched controls, and the investigators have reported acceptable measurement reliability (ICC2,k = 0.85)|8-weeks from Baseline|Difference in baseline individuals and number of participants are due to a proportion of patients lost to follow up and participants electing not to undergo voluntary quadriceps activation.|||percentage of full activation||Standard Deviation|Mean
2562692|NCT02634814|Primary|Mean in Self-reported Disability Score as Measured by the Western Ontario and McMasters Universities Index Between Groups|The Western Ontario and McMasters Universities Index is reliable and valid measure of self reported disability. The physical function consists of 17 items and asks about the magnitude of difficulty when ascending and descending stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, completing heavy household duties, and completing light household duties. Each item is presented in a 5 point Likert-type format and uses the following descriptors for possible answer choices none, mild moderate, severe, and extreme. Each descriptor corresponds to an ordinal scale of 0-4. The scores are summed for the items in each subscale, with total possible ranges as 0-68. Higher scores on the WOMAC indicate greater amounts of functional limitations.|8-weeks from Baseline|A proportion of the participants were lost to follow-up.|||score on a scale||Standard Deviation|Mean
2562693|NCT02634801|Secondary|Mean Adherence on Medication and Satisfaction With Therapy (STAQ)|"Systemic Therapy Adherence Questionnaire (STAQ) is a 38 item questionnaire that was developed by shortening and adapting the Topical Treatment Adherence Questionnaire (TTAQ) for administration to participants under systemic therapy. The following STAQ items are of special interest for this study.~STAQ item 13 (The treatment does not affect my sex life)~STAQ item 16 (I am enjoying life again as a result of the treatment)~STAQ item 20 (The side effects of the treatment were acceptable)~STAQ item 31 (I am satisfied with the efficacy of the treatment)~STAQ item 32 (I am satisfied with the tolerability of the treatment)~STAQ item 35 (The positive aspects of the treatment outweigh the negative ones).~The STAQ items are on a 4-point Likert scale with scores between 0 (strong disagreement) and 3 (strong agreement). LS mean was calculated using ANCOVA with term for treatment."|Week 24|All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for Systemic Therapy Adherence Questionnaire (STAQ).|||units on a scale||95% Confidence Interval|Least Squares Mean
2562694|NCT02634801|Secondary|Percentage of Participants Positive Responses to Genital Psoriasis Question|"Studying psoriasis involvement in the face, neck, and the genitals is of considerable interest for participants. These are locations that bear high potential for stigmatization and/or psychological distress, and, hence, effects in those regions are assumed to heavily influence participant's quality of life.~Following set of binary questions were asked to check the satisfaction of participants.~Does the patient currently have visible psoriasis on face/neck? (Yes/No)~Does the patient currently have psoriasis on the genital area? (Yes/No) The genital area includes the labia majora (hair-bearing), labia minora modified mucus membrane, and perineum in female patients; and the penis glans, penis - shaft, and scrotum in male patients."|Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for binary questions.~Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis."|||Percentage of participants|||Number
2562695|NCT02634801|Secondary|Percentage of Participants With Positive Responses to Neck/Face Psoriasis Question|"Studying psoriasis involvement in the face, neck, and the genitals is of considerable interest for participants. These are locations that bear high potential for stigmatization and/or psychological distress, and, hence, effects in those regions are assumed to heavily influence participant's quality of life.~Following set of binary questions were asked to check the satisfaction of participants.~Does the participant currently have visible psoriasis on face/neck? (Yes/No)~Does the participant currently have psoriasis on the genital area? (Yes/No)"|Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for binary questions.~Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis."|||Percentage of Participants|||Number
2562696|NCT02634801|Secondary|Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Overall Work Impairment Score|"The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100), where 0 (no impairement) and 100 (greater impairment).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for WPAI-PSO.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2562697|NCT02634801|Secondary|Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Impairment in Activities Performed Outside of Work|"The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100), where 0 (no impairement) and 100 (greater impairment).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for WPAI-PSO.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2562739|NCT02634580|Secondary|Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562698|NCT02634801|Secondary|Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Presenteeism Score|"The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100), where 0 (no impairement) and 100 (greater impairment).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for WPAI-PSO Presenteeism score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2562699|NCT02634801|Secondary|Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO), Absenteeism Score|"The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100), where 0 (no impairement) and 100 (greater impairment).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for WPAI-PSO absenteeism score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2562700|NCT02634801|Secondary|"Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) Bolt On - Visual Analog Scale Score"|"The EQ-5D 5L is a standardized measure of health status that includes a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (worst health imaginable)- to 100 (best health imaginable)-millimeter (mm) Visual Analog Scale (VAS).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for EQ-5D 5L + Bolt on VAS.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||Millimeter (mm)||95% Confidence Interval|Least Squares Mean
2562701|NCT02634801|Secondary|"Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) Bolt On - Psoriasis (PSO) Index Score"|"The European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of a descriptive system of the respondent's health which comprises the following 5 dimensions: 1) mobility 2) self-care 3) usual activities 4) pain/discomfort 5) anxiety/depression. The Bolt On PSO is an addition to the EQ-5D-5L that consists of 2 dimensions specific to psoriatic disease: 6) skin irritation (itching) and 7) self-confidence. Index scores for the Bolt On PSO range from 0.0042 to 1.0 (worse to better health).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for EQ-5D 5L Bolt On PSO-Index.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2562702|NCT02634801|Secondary|Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D) + Bolt On UK Population-based Index Score|"The European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of a descriptive system of the respondent's health which comprises the following 5 dimensions: 1) mobility 2) self-care 3) usual activities 4) pain/discomfort 5) anxiety/depression. The EQ-5D-5L health states were converted into a single summary index by applying a crosswalk using a United Kingdom (UK) Population value set to each of the levels in each dimension. This produced participant-level index scores between -0.594 and 1.0 (worse to better health).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for EQ-5D 5L Index.mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
2562703|NCT02634801|Secondary|Change From Baseline on the Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA-CLIN) Total Score|"NAPPA is a clinical and participant-reported outcomes tool, and consists of 3 components: a questionnaire assessing nail-specific quality of life NAPPA-QoL (Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life), a 2-part questionnaire assessing participant relevant needs and treatment benefits NAPPA-PBI (Nail Assessment in Psoriasis and Psoriatic Arthritis - Patient Benefit Index), and a clinical assessment of objective finger nail psoriasis severity NAPPA-CLIN.~Sum of all assessed finger and toes ranging between 0 (no involvement) to 16 (worst involvement).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who had palmoplantar, scalp, or nail involvement at baseline.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2562704|NCT02634801|Secondary|Change From Baseline on the Psoriasis Skin Appearance Bothersomeness (PSAB) Total Score|"PSAB measure is a 3-item scale designed to measure the degree of bothersomeness of skin appearance due to Ps in participants with Ps. Participants are asked to indicate on 3 numeric rating scales (NRS) from 0 (not at all bothered) to 10 (extremely bothered) how bothered they are by any redness or discoloration, thickness, and scaling or flaking on their skin due to Ps.~The scores from the 3 NRS items are summed for a total score ranging from 0 to 30, where 0 indicating no bothersomeness and 30 indicating greater bothersomeness.~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for PSAB.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2562705|NCT02634801|Secondary|Change From Baseline on Patient's Global Assessment (PatGA) of Disease Severity|"The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis today by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for PatGA.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2562706|NCT02634801|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Scores|"The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, lower scores = more disability, higher scores = less disability and better health. In this study, the SF-36 acute version was used, which has a 1-week recall period.~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for SF36 MCS score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2562707|NCT02634801|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS)|"The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, lower scores = more disability, higher scores = less disability and better health. In this study, the SF-36 acute version was used, which has a 1-week recall period.~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for SF36 PCS score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2562708|NCT02634801|Secondary|Change From Baseline on Quick Inventory of Depressive Symptomatology-Self Report (16 Items) (QIDS-SR16)|"QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. Whereas 0-5 indicates no symptoms.~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for QIDS-SR16.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2562709|NCT02634801|Secondary|Change From Baseline on the Skin Pain Visual Analog Scale (VAS)|"The pain VAS is a participant-administered single-item scale designed to measure Skin pain from Psoriasis using a 100 millimeter (mm) horizontal VAS. Overall severity of participant's skin pain from Psoriasis is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (pain as severe as you can imagine).~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for skin pain VAS.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||Millimeter (mm)||95% Confidence Interval|Least Squares Mean
2562710|NCT02634801|Secondary|Change From Baseline on Itch Numeric Rating Scale (NRS) Score|"The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participant's itching from psoriasis (Ps) is indicated by circling the number that best describes the worst level of itching in the past 24 hours.~LS mean change from baseline was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for Itch NRS score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2562711|NCT02634801|Secondary|Patient Benefit Index (PBI) Overall Benefit Score|"The PBI assessment consists of 2 steps: before treatment, every patient defines his/her treatment needs according to a standardized list (Patient Needs Questionnaire [PNQ]). After treatment, the patient rates the degree of benefits achieved (Patient Benefits Questionnaire [PBQ]). 25 items are rated on a 5-point scale with values from 0 (not at all) to 4 (very), allowing for did not apply to me (5) and missing.~For each treatment goal the PNQ importance is derived by dividing the respective PNQ item by the sum of all PNQ items. The weighted sum of each PBQ item with its respective PNQ importance yields the PBI score.~LS mean was calculated using ANCOVA with LOCF and with a term for treatment."|Week 24|All randomized participants who received at least 1 dose of study drug and had a baseline PBI questionnaire such that postbaseline PBI assessments can be valid (nonmissing).|||units on a scale||95% Confidence Interval|Least Squares Mean
2562712|NCT02634801|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score|"The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity).~LS mean change from baseline in PSSI was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for Psoriasis Scalp.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2562713|NCT02634801|Secondary|Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score|"The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline.~LS mean change from baseline in PPASI was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for PPASI.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2562714|NCT02634801|Secondary|Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis|"The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb.~LS mean change from baseline in BSA was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for BSA.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||% Body Surface Affected||95% Confidence Interval|Least Squares Mean
2562715|NCT02634801|Secondary|Change From Baseline on Dermatology Life Quality Index (DLQI) Total Score|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment), and a 5-point change from baseline is considered clinically relevant. LS mean change from baseline in DLQI was calculated using ANCOVA with mBOCF and with terms for baseline and treatment."|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for DLQI.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2562716|NCT02634801|Secondary|Percentage of Participants Achieving DLQI (0,1)|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment), and a 5-point change from baseline is considered clinically relevant."|Week 24|All randomized participants who had a post-baseline measurement for DLQI. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.|||Percentage of Participants|||Number
2562717|NCT02634801|Secondary|Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) and ≥2 Point Improvement From Baseline Among Those With sPGA Score ≥3 at Baseline|"The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline."|Week 24|All randomized participants with baseline sPGA >=3 & received at least 1 dose of study drug and had a post-baseline measurement for sPGA. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.|||Percentage of Participants|||Number
2562728|NCT02634788|Secondary|Time to Peak Pain Relief|Time to peak pain relief is the time to the highest value of pain relief experienced during the study. Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). If no pain relief was observed, then the time was censored at the time of the last pain assessment.|From Time 0 (first dose of study drug) to time of peak pain relief (up to 1437 minutes)|All randomized participants from the ITT Population|||minutes||95% Confidence Interval|Median
2562718|NCT02634801|Secondary|Change From Baseline in PASI Total Score|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). LS mean change from baseline in PASI was calculated using Analysis of Covariance (ANCOVA) with modified Baseline- Observation- Carried Forward (mBOCF) and with terms for baseline and treatment.|Baseline, Week 24|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for PASI.~mBOCF: Participants who discontinued treatment due to Adverse Event (AE) were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2562719|NCT02634801|Secondary|Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) From Baseline|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week 24|All randomized participants who had a post-baseline measurement for PASI 100. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.|||Percentage of Participants|||Number
2562720|NCT02634801|Secondary|Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week 24|All randomized participants who had a post-baseline measurement for PASI 90. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.|||Percentage of Participants|||Number
2562721|NCT02634801|Primary|Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week 24|All randomized participants who had a post-baseline measurement for PASI 75. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.|||Percentage of Participants|||Number
2562722|NCT02634788|Secondary|Participant's Global Evaluation of Study Drug|Global evaluation of study drug was completed at the end of treatment (Day 3) or before early termination if a participant discontinued early. Participants were asked to provide an overall rating of their study medication in controlling pain on a 5-point NRS, where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent. The percentage of participants with scores in each pain relief category are reported.|End of treatment (Day 3) or early termination|All randomized participants from the ITT Population.|||percentage of participants|||Number
2562723|NCT02634788|Secondary|Total Use of Rescue Medication Over 0 to 24 Hours and 0 to 48 Hours|Total use of rescue medication is defined as the number of times a participant took rescue medication.|Over 24 and 48 hours after Time 0 (first dose of study drug)|All randomized participants from the ITT Population who used rescue medication during the specified time intervals.|||number of uses||Standard Deviation|Mean
2562724|NCT02634788|Secondary|Time to First Use of Rescue Medication for Pain|Time to first use of rescue medication is the time from Time 0 (time of administration of the first dose of study drug) to the first use of rescue medication. If rescue medication was not taken the time was censored at the time of the last pain assessment.|From Time 0 to time of first use of rescue medication (up to 280 minutes)|All randomized participants from the ITT Population.|||minutes||95% Confidence Interval|Median
2562725|NCT02634788|Secondary|Percentage of Participants Using Rescue Medication for Pain|The percentage of participants who needed to take an alternate medication for pain relief during the treatment period.|From Time 0 (first dose of study drug) up to 48 hours|All randomized participants from the ITT Population.|||percentage of participants|||Number
2562726|NCT02634788|Secondary|Time to Meaningful Pain Relief|Time to meaningful pain relief was evaluated using the 2 stopwatch method and is defined as the time when the participant stops the second stopwatch. If it was not stopped time was censored at the time that the second stopwatch was stopped or the time of the second dose or the time that rescue medication was used whichever came first.|From Time 0 (first dose of study drug) to time of meaningful pain relief (up to 227 minutes)|All randomized participants from the ITT Population.|||minutes||95% Confidence Interval|Median
2562727|NCT02634788|Secondary|Time to First Perceptible Pain Relief|Time to first perceptible pain relief was evaluated using the 2 stopwatch method and is defined as the time when the participant stops the first stopwatch. If it was not stopped time was censored at the time that the second stopwatch was stopped or the time of the second dose or the time that rescue medication was used whichever came first.|From Time 0 (first dose of study drug) to time of first perceptible pain relief (up to 83 minutes)|All randomized participants from the ITT Population.|||minutes||95% Confidence Interval|Median
2562729|NCT02634788|Secondary|Percentage of Participants With Peak Scores in Each Pain Relief Category|Peak pain relief is the highest value of pain relief experienced during the study. Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). The percentage of participants with peak scores in each pain relief category are reported.|From Time 0 (first dose of study drug) up to 48 hours|All randomized participants from the ITT Population|||percentage of participants|||Number
2562730|NCT02634788|Secondary|Percentage of Participants With Scores in Each Pain Relief Category at 4, 8, 24 and 48 Hours After Time 0|Pain relief was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). The percentage of participants with scores in each pain relief category are reported. Missing values were imputed.|4, 8, 24 and 48 hours after Time 0 (first dose of study drug)|All randomized participants from the ITT Population|||percentage of participants|||Number
2562731|NCT02634788|Secondary|Time to Onset of Analgesia|Time to onset of analgesia was measured as time to first perceptible pain relief confirmed by meaningful pain relief using the 2-stopwatch method. The study staff started 2 stopwatches as soon as the first dose of study drug was administered. Each participant was instructed to stop the first stopwatch when he or she experienced any perceptible pain relief and the second stopwatch when he or she experienced pain relief that was meaningful to them. If the second stopwatch was not stopped, time was censored at the time of the second dose of study drug or the use of rescue medication, whichever came first. If both stopwatches were not stopped time was censored at the time of the second dose of study drug or the use of rescue medication whichever came first. Time to onset of analgesia was defined as the time when the first stopwatch was stopped given that the second stopwatch is stopped.|From Time 0 (first dose of study drug) to time of confirmed meaningful pain relief (up to 64 minutes)|All randomized participants from the ITT Population.|||minutes||95% Confidence Interval|Median
2562732|NCT02634788|Secondary|Total Pain Relief (TOTPAR) Over 4, 8, 24 and 48 Hours After Time 0|TOTPAR was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). TOTPAR scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (first dose of study drug). The TOTPAR scores are the sum of the pain relief at each time point multiplied by the duration in hours since the previous time point. Larger positive numbers indicate more pain relief (maximum=4 at each time point) and smaller positive numbers indicate less pain relief (minimum=0 at each time point). The overall minimum is 0 for each variable and the overall maximum is 4 times the number of hours specified for the variable: TOTPAR-4=(0 to 16), TOTPAR-8=(0 to 32), TOTPAR-24=(0 to 96) and TOTPAR-48=(0 to 192). TOTPAR-4, TOTPAR-8, TOTPAR-24 and TOTPAR-48 were analyzed using an ANCOVA model with factors for treatment, site and baseline pain intensity.|4, 8, 24 and 48 hours after Time 0|All randomized participants from the ITT Population with data available at each timepoint.|||units on a scale||Standard Error|Least Squares Mean
2562733|NCT02634788|Secondary|NRS SPID Over 4 Hours (SPID-4), 8 Hours (SPID-8) and 24 Hours (SPID-24) After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [max=10 at each time point] and negative numbers indicate an increase in pain [min=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified: SPID-4=(-40 to 40), SPID-8=(-80 to 80) and SPID-24=(-240 to 240). The NRS SPID-4, 8 and 24 were analyzed using an ANCOVA model which included treatment and site as main effects and Baseline pain intensity as the covariate.|Baseline and 0 to 4, 0 to 8 and 0 to 24 hours after Time 0|All randomized participants from the Intent-to-Treat (ITT) Population who did not have missing SPID values.|||units on a scale||Standard Deviation|Least Squares Mean
2562734|NCT02634788|Secondary|NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain.|4, 8, 24 and 48 hours after Time 0|All randomized participants from the ITT Population with data available at each timepoint.|||units on a scale||Standard Deviation|Mean
2562735|NCT02634788|Secondary|NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). NRS PID is defined as the difference in pain at each scheduled timepoint relative to Baseline (PID=pain intensity at baseline - pain intensity at time point). A higher value of NRS PID score indicates a higher decrease in pain from Baseline.|Baseline and 4, 8, 24 and 48 hours after Time 0|All randomized participants from the ITT Population with data available at each timepoint.|||units on a scale||Standard Deviation|Mean
2562736|NCT02634788|Primary|Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48)|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum(max)=10 at each time point], and negative numbers indicate an increase in pain [minimum(min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.|Baseline and 0 to 48 hours after Time 0|All randomized participants from the Intent-to-Treat (ITT) Population who did not have missing SPID-48 values. Missing SPID-48 data were not imputed.|||units on a scale||Standard Error|Least Squares Mean
2562740|NCT02634580|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562741|NCT02634580|Secondary|Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562742|NCT02634580|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562743|NCT02634580|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562744|NCT02634580|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562745|NCT02634580|Secondary|Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562746|NCT02634580|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562747|NCT02634580|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562748|NCT02634580|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562749|NCT02634580|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562750|NCT02634580|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562751|NCT02634580|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562752|NCT02634580|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562753|NCT02634580|Secondary|Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562754|NCT02634580|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562755|NCT02634580|Secondary|Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562756|NCT02634580|Secondary|Percentage of Participants Who Achieved a LDL-C of Less Than 70 mg/dL at Week 12||Week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percentage of participants||95% Confidence Interval|Number
2562757|NCT02634580|Secondary|Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL|Mean low density lipoprotein-cholesterol response was defined as LDL-C < 70 mg/dL [1.8 mol/L].|Weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percentage of participants||95% Confidence Interval|Number
2562758|NCT02634580|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||mg/dL||Standard Error|Least Squares Mean
2562759|NCT02634580|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||mg/dL||Standard Error|Least Squares Mean
2562760|NCT02634580|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and week 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562761|NCT02634580|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12|For all efficacy endpoints the two dosing regimens (every 2 weeks and every month) for each treatment were pooled for analysis.|Baseline and Weeks 10 and 12|All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.|||percent change||Standard Error|Least Squares Mean
2562762|NCT02634346|Secondary|Incidence of Adverse Events||Approximately 4 weeks|Number of subjects who received study drug and had a treatment-emergent adverse event|||Participants|||Count of Participants
2562786|NCT02634073|Primary|Time to Observed Maximum Lamivudine Plasma Concentration (Tmax), Time of Last Measurable Plasma Concentration (Tlast) and Absorption Lag Time in Plasma (Tlag)|Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period.|Day 1 to Day 3 in each treatment period||||Hr||Full Range|Median
2562763|NCT02634346|Secondary|Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4|"The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients. Results indicate a change in CGI-S score from baseline to Week 4 based on the observed data. Change is calculated between the baseline visit and Week 4."|4 weeks|Subjects who received at least 1 dose of study drug and had at least 1 post-baseline PANSS assessment.|||units on a scale||Standard Error|Least Squares Mean
2562764|NCT02634346|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4|This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and Week 4.|4 weeks|Subjects that received at least 1 dose of study drug and had at least 1 post-baseline PANSS assessment.|||units on a scale||Standard Error|Least Squares Mean
2562765|NCT02634320|Secondary|Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS)|"The BAS is a 19-item scale completed by the caregiver that focuses on specific subjective and objective consequences of families caring for individuals with severe mental disorders. Respondents are required to indicate whether they have experienced each of the types of burden - 'Not at all', 'A little', 'Some' or A lot' - in the previous four weeks. These are scored 1, 2, 3 and 4, respectively. The total score ranges between 19 and 76. A higher score indicates more perceived burden. Subjects required a reliable informant (caregiver) in order to participate in the study. These caregivers did not receive study treatment, and they are not represented elsewhere in the results data. The data provided indicates the change from baseline to the last treatment visit."|Up to 7 months|Subjects who received at least one dose of study drug, had a last on-treatment visit, and had an unpaid caregiver providing information.|||units on a scale||Standard Deviation|Mean
2562766|NCT02634320|Secondary|Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6)|Responses to 4 mTSR-6 questions have been provided. Results include the number of participants who responded positively to the category during the entire post-baseline treatment period.|Up to 7 months||||participants|||Number
2562767|NCT02634320|Secondary|Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS)|The QLS is a clinician-rated scale that is used to assess health-related quality of life and functioning in patients with schizoprehnia during the preceding 4 weeks. The QLS consists of 21 items in 4 major domains (Intrapsychic Foundations, Interpersonal Relations, Instrumental Role, and Common Objects and Activities). Following a semi-structured interview, each item is rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning).|Up to 7 months|Subjects who had at least one dose of study drug and had a last on-treatment visit.|||units on a scale||Standard Deviation|Mean
2562768|NCT02634320|Secondary|Number of Participants With Adverse Events||Up to 7 months|Safety population includes all subjects who received at least 1 dose of study drug.|||Participants|||Count of Participants
2562769|NCT02634320|Secondary|Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores|The BPRS is an instrument for evaluating change in psychopathology in patients with schizophrenia. It consists of 18 items in which clinicians rate patient symptoms on a 7-point scale (1=not present, 7=extremely severe). Scores range from 18 to 126, with higher scores indicative of more severe psychopathology).|Up to 7 months|Safety population includes all subjects who received at least 1 dose of study drug and had a last on-treatment visit.|||units on a scale||Standard Deviation|Mean
2562770|NCT02634320|Primary|Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores|"The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients. Results indicate a change in CGI-S score from baseline to last visit in the treatment period based on the observed data."|Up to 7 months|Safety population includes all subjects who received at least 1 dose of study drug and had a last on-treatment visit.|||units on a scale||Standard Deviation|Mean
2562771|NCT02634073|Secondary|Change From Baseline in Albumin|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for albumin was calculated as the post-dose Visit Value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/Period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||G//L||Standard Deviation|Mean
2562772|NCT02634073|Secondary|Change From Baseline in Creatinine, Total Bilirubin and Direct Bilirubin|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for creatinine and direct bilirubin were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Change from Baseline in total bilirubine was not assessed. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||micromole (umol)/L||Standard Deviation|Mean
2562773|NCT02634073|Secondary|Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphates|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for AST, ALT and alkaline phosphatase were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||Unit (U)/L||Standard Deviation|Mean
2562893|NCT02632110|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline||||AK Fields|AK Fields||Count of Units
2562774|NCT02634073|Secondary|Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Glucose, Calcium|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for BUN, sodium, potassium, glucose, calcium were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||millimole (mmol)/L||Standard Deviation|Mean
2562775|NCT02634073|Secondary|Change From Baseline in Platelets, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils were calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||10^9 cells/L||Standard Deviation|Mean
2562776|NCT02634073|Secondary|Change From Baseline in Mean Corpuscular Volume (MCV)|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for MCV was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||Femtoliter||Standard Deviation|Mean
2562777|NCT02634073|Secondary|Change From Baseline in Mean Corpuscular Hemoglobin (MCH)|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for MCH was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||Picogram||Standard Deviation|Mean
2562778|NCT02634073|Secondary|Change From Baseline in Hemoglobin|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for hemoglobin was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||G/L||Standard Deviation|Mean
2562779|NCT02634073|Secondary|Change From Baseline in Hematocrit|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for hematocrit was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||Fraction of 1||Standard Deviation|Mean
2562780|NCT02634073|Secondary|Change From Baseline in Erythrocytes|Blood samples were collected at Day -1, Day 3 of every treatment period and at follow-up. Change from Baseline for erythrocytes was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/Period. Day -1 presented the Baseline absolute values; Day 3 and Follow-Up presented the changes from Baseline.|Baseline and up to 5 weeks|Safety Population|||10^12 cells/L||Standard Deviation|Mean
2562781|NCT02634073|Secondary|Number of Participants With Treatment Emergent Laboratory Abnormality Grade|Division of Acquired immune deficiency syndrome (DAIDS) Table AE grades 1, 2, 3, and 4 of laboratory abnormalities were applied and grade were summarized by treatment and day and were listed by participant, treatment, day, and actual date and time. Treatment emergent grades are defined as any new toxicity grades or the worsened grades compared to Baseline grade. Treatment emergent lab abnormality Grade 1 for aspartate aminotransferase and sodium at follow-up visit are summarized.|Up to Week 5|Safety Population|||Participants|||Number
2562782|NCT02634073|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Change from Baseline for DBP and SBP was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period.|Baseline and up to 5 weeks|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2562783|NCT02634073|Secondary|Change From Baseline in Body Temperature|Change from Baseline for body temperature was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period.|Baseline and up to 5 weeks|Safety Population|||Degree centigrade||Standard Deviation|Mean
2562784|NCT02634073|Secondary|Change From Baseline in Pulse Rate|Change from Baseline for pulse rate was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period.|Baseline and up to 5 weeks|Safety Population.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Beats/min||Standard Deviation|Mean
2562785|NCT02634073|Secondary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAE)|An AE is any untoward medical occurrence, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|Up to 5 Weeks|Safety Population: defined as all participants who enrolled into the study and received at least one dose of study drug.|||Participants|||Number
2563024|NCT02630472|Primary|Change in Microbiome Profile|Pre and post treatment endoscopically-obtained sinonasal microbiologic cultures.|Baseline, Week 2, and Week 10|This study was terminated. Partial data was collected and is misleading due to mis-dosing. This outcome measure was not evaluated.||||||
2562787|NCT02634073|Primary|Plasma Lamivudine Apparent Oral Clearance (CL/F)|Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. ANOVA, considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine CL/F|Day 1 to Day 3 in each treatment period|PK Summary Population|||Liter (L)/hr||Geometric Coefficient of Variation|Geometric Mean
2562788|NCT02634073|Primary|Lamivudine Elimination Half-life in Plasma (t1/2)|Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. ANOVA, considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine t1/2.|Day 1 to Day 3 in each treatment period|PK Summary Population|||Hour (Hr)||Geometric Coefficient of Variation|Geometric Mean
2562789|NCT02634073|Primary|Plasma Lamivudine Maximum Observed Concentration (Cmax), Concentration at 24 Hour (h) Post-dose (C24) and Last Measurable Concentration (Ct)|Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. Time of the last measurable concentration (t) was 48 hours for all participants and all treatments. ANOVA, considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine PK parameters.|Day 1 to Day 3 in each treatment period||||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2562790|NCT02634073|Primary|Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24])|Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. AUC was determined using the trapezoidal rule. Analysis of variance (ANOVA), considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine Pharmacokinetic (PK) parameters.|Day 1 to Day 3 in each treatment period|PK Summary Population: defined as participants who had valid lamivudine PK parameter estimates from both reference and test treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||hour (h)*microgram (mcg)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
2562791|NCT02633956|Primary|The Effect of Obeticholic Acid on LDL Particle Concentration (Total) (Least Squares Mean Change From Baseline at Week 16)|The effect of Obeticholic Acid on LDL metabolism in subjects with biopsy confirmed nonalcoholic NASH and the ability of atorvastatin to modulate this effect as measured by change (least squares mean) from baseline at week 16 in LDL particle concentration (total)|Baseline and Week 16|Efficacy evaluable population|||nmol/L||Standard Error|Least Squares Mean
2562792|NCT02633956|Primary|The Effect of Obeticholic Acid on LDL Particle Size (Least Squares Mean Change From Baseline at Week 16)|The effect of Obeticholic Acid on LDL metabolism in subjects with biopsy confirmed NASH and the ability of atorvastatin to modulate this effect as measured by change from baseline (least squares mean) at week 16 in LDL particle size. It is LDL particle diameter size (nm) that is reported.|Baseline and Week 16|Efficacy evaluable population|||nm||Standard Error|Least Squares Mean
2562793|NCT02633956|Primary|The Effect of Obeticholic Acid on Low-density Lipoprotein (LDL) Concentration (Least Squares Mean Change From Baseline at Week 16)|The effect of Obeticholic Acid on LDL metabolism in subjects with biopsy confirmed nonalcoholic steatohepatitis (NASH) and the ability of atorvastatin to modulate this effect as measured by change (least squares mean) from baseline at week 16 in LDL concentration|Baseline and Week 16|Efficacy evaluable population|||mg/dL||Standard Error|Least Squares Mean
2562794|NCT02633800|Secondary|Percentage of Participants With Best Overall Response|Best overall response rate (ORR) is defined as the percentage of participants with Complete Response (CR) or Partial Response (PR)|at approximately 22 months|The trial terminated before sufficient data were collected for this analysis (at approximately 12 months which is prior to the time point for this analysis).||||||
2562795|NCT02633800|Secondary|Median Overall Survival|Overall survival (OS) is defined as the time from the date of randomization to death due to any cause|at approximately 25 months|The trial terminated before sufficient data were collected for this analysis (at approximately 12 months which is prior to the time point for this analysis).||||||
2562796|NCT02633800|Primary|Progression Free Survival (PFS) in the Heregulin (HRG)-High Expression Population|"PFS is defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever comes first.~Median PFS is from Kaplan-Meier analysis. Confidence interval (CI) for median was computed using Brookmeyer-Crowley method."|from Day 0 to end of active study (study termination) - within 12 months|Participants in the heregulin-high expression population|||months||95% Confidence Interval|Median
2562797|NCT02633787|Primary|Geometric Mean Titers of Meningococcal Antibodies Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination|Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.|Pre-booster, 28 Days and 4 years post-booster vaccination|Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2562798|NCT02633787|Primary|Percentage of Participants With Meningococcal Antibody Titers ≥ 1:8 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination|Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.|Pre-booster vaccination, 28 days and 4 years post-booster vaccination|Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
2562799|NCT02633787|Primary|Percentage of Participants With Meningococcal Antibody Titers ≥ 1:4 Before, 28 Days After, and Approximately Four Years Following Menactra Vaccine Booster Vaccination.|Anti-meningococcal antibody titers for serogroups A, C, Y, and W-135 were measured using a serum bactericidal assay with human complement.|Pre-booster vaccination, 28 days, and 4 years post-booster vaccination|Anti-meningococcal antibody titers were assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
2566422|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Total Cholesterol||Baseline, Week 48|Participants with measurements at given time point.|||mmol/L||Standard Deviation|Mean
2562800|NCT02633501|Primary|Contrast to Noise Ratio (CNR) Difference|The Contrast-to-Noise Ratio (CNR) was calculated from the signal intensity measurement of maximum 3 enhanced lesions by 3 independent blinded readers. Only lesions detected by both MRIs after lesion tracking were used. The difference in CNR was calculated as follow: CNR (P03277) - CNR (gadobenate dimeglumine).|1 day procedure|The analysis was done for each of the 3 independent off-site readers using the Per Protocol Set that included all subjects without major protocol deviations. A subject was analyzed as soon as he had a matching evaluation of the CNR at both MRIs by at least 1 off-site reader. Therefore, the numbers of subjects analyzed by reader could be different.|||Ratio||95% Confidence Interval|Least Squares Mean
2562801|NCT02633488|Primary|Flow Mediated Dilation - Endothelial Function|brachial artery ultrasonography % flow-mediated dilatation (FMD) for assessing endothelial function before and after an insulin clamp to assess insulin's effect on the vasculature|before and after 12 weeks on placebo or metformin||||percentage of artery dilation||Standard Error|Mean
2562802|NCT02633371|Primary|Number of Patients With Improvement in Hyperhidrosis Severity at Week 1 or Week 4 as Measured by the Hyperhidrosis Disease Severity Scale (HDSS).|A treatment responder is defined as any participant with a change in the Hyperhidrosis Disease Severity Scale (HDSS) score from a baseline score of 3 or 4 to a score of 1 or 2 at week 1 or week 4.|Week 1 and week 4||||participants|||Number
2562803|NCT02633358|Other Pre-specified|Soluble Interleukin-6 Receptor - the Plasma Level of Participants|Check the soluble Interleukin-6 plasma level at 6 hours and 24 hours after enrollment|between 6 and 24 hours after enrollment||||ng/mL||Standard Error|Mean
2562804|NCT02633358|Other Pre-specified|Interleukin-6/Soluble Interleukin-6 Receptor Complex - the Plasma Level of Participants|Interleukin-6/soluble Interleukin-6 receptor complex plasma level hint the pro-inflammatory pathway via Interleukin-6 trans-signaling|between 6 and 24 hours after enrollment||||pg/mL||Standard Error|Mean
2562805|NCT02633358|Other Pre-specified|Interleukin-6 - the Plasma Level of Participants|IL-6 level change|between 6 and 24 hours after enrollment.|Randomized divided to two groups including therapeutic hypothermia and non-hypothermia group|||pg/mL||Standard Error|Mean
2562806|NCT02633358|Secondary|Neurologic Outcome - Number of Participants|Neurological outcome according to Cerebral performance Category scales: scales 1-2 in favor of favorable neurological outcome; scales 3-5 in favor of poor neurological outcome including severe cerebral disability, coma or vegetative state, brain death.|90 days after enrollment|Randomized divided to two groups including therapeutic hypothermia group and non-hypothermia group|||Participants|||Count of Participants
2562807|NCT02633358|Primary|Survival Rate - Number of Participants Alive|Survival rate according to the number of participants alive in the 90 days after enrollment.|90 days after enrollment|Randomized divided to two groups including therapeutic hypothermia group and non-hypothermia group|||Participants|||Count of Participants
2562808|NCT02633241|Secondary|Recovery Time|number of minutes in the recovery area until the patient appeared awake (eye opening),|from competion of the MRI scan until prepared for discharge - approximately 90 minutes||||minutes||Inter-Quartile Range|Median
2562809|NCT02633241|Secondary|Case Duration|total number of minutes in the MRI scanner,|Duration of the MRI scan - approximately one hour||||minutes||Inter-Quartile Range|Median
2562810|NCT02633241|Secondary|Sedation Infusion Time|The number of minutes that the patient was receiving dexmedetomidine infusion,|For the duration of the MRI scan - approximately one hour||||minutes||Inter-Quartile Range|Median
2562811|NCT02633241|Secondary|Incidence of Technique Failure|lack of adequate sedation for MRI scan in spite of the sedation as described above|During the MRI scan until completion - approximately one hour||||incidents|||Number
2562812|NCT02633241|Primary|Case Times|Number of minutes from the start of sedation medication administration to the time the patient is adequately sedated for the MRI scan,|Timeframe immediately before the MRI scan while sedation medication is administered - approximately 10 minutes||||minutes||Inter-Quartile Range|Median
2562813|NCT02633241|Primary|Incidence of Adverse Events|arterial desaturation, airway obstruction, hypotension and bradycardia|From the time the medication is initiated just (5 minutes) prior to the MRI scan and during the MRI scan and immediately during recovery - approximately one hour and twenty minutes in total.||||incidents||95% Confidence Interval|Number
2562814|NCT02633241|Primary|Incidence of Patient Movement and MRI Interruption||During the MRI scan, until completion, approximately one hour.||||patients|||Number
2562815|NCT02633241|Primary|Dosage/Consumption|Dosage and consumption of dexmedetomidine|Prior to beginning the MRI and throughout the MRI scan - approximately one hour.|Patients who completed the study.|||mcg/kg/min||95% Confidence Interval|Mean
2562816|NCT02633215|Secondary|Change in Wolf Motor Function Test (WMFT)|Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. Each task is scored as amount of time taken to complete a task, which may range from just over 0 to 120 seconds. If the subject is unable to complete the task within 120 seconds, a score of 121 seconds is given. The scores from the 15 individual tasks are averaged, then the log is taken, resulting in the overall score. Therefore, the larger the score, the longer required to perform the tasks. Negative changes in score indicate that a subject, on average, was able to complete the tasks faster at post-intervention or at 1-month follow-up than at baseline.|baseline, post-intervention, 1-month follow-up||||log(seconds)||Standard Error|Mean
2562817|NCT02633215|Secondary|Change in Action Arm Research Test (ARAT)|Score at post-intervention minus baseline, score at 1-month follow-up minus baseline. The possible scores range from 0 to 57, with higher scores indicating better performance.|baseline, post-intervention, 1-month follow-up||||units on a scale||Standard Error|Mean
2562818|NCT02633215|Primary|Change in Fugl Meyer Assessment Motor Score|Score after intervention minus baseline score, score at 1-month follow-up minus baseline score. The possible scores range from 0 to 66, with 66 indicating the best performance.|baseline, post-intervention, 1-month follow-up||||units on a scale||Standard Error|Mean
2562819|NCT02633020|Secondary|Change From Baseline in Total Celiac Disease GSRS (CeD-GSRS) Score at Week 12|"The CeD-GSRS score is derived from a subset of 10 questions from the GSRS questionnaire (questions 1, 4-9, 11, 12 and 14), which are each assessed on a scale of 1 (no discomfort at all) to 7 (very severe discomfort).~The total CeD-GSRS score ranges from 10 (no discomfort at all) to 70 (very severe discomfort in all celiac syndromes)."|Baseline and week 12|Intent-to-treat population with available data.|||units on a scale||Standard Error|Least Squares Mean
2562820|NCT02633020|Secondary|Change From Baseline in Total Weekly Gastrointestinal Symptom Rating Scale (GSRS) Score at Week 12|"The GSRS is a 15-question 7-scale questionnaire used to assess 5 dimensions of gastrointestinal syndromes: diarrhea, indigestion, constipation, abdominal pain and reflux. Questions are scored between 1 (no discomfort at all) and 7 (very severe discomfort).~The total GSRS score is calculated as the sum of the scores of all 15 questions, and ranges from 15 (no discomfort at all) to 105 (very severe discomfort in all 5 dimensions of gastrointestinal syndromes)."|Baseline and week 12|Intent-to-treat population with available data.|||units on a scale||Standard Error|Least Squares Mean
2562821|NCT02633020|Secondary|Percentage of Participants With Diarrhea at Baseline and Week 12|"The Bristol Stool Form Scale (BSFS) is a pictorial aid to help participants identify the shape and consistency of their bowel movements. Participants were asked to complete this form daily using an electronic diary at the time of each bowel movement. The BSFS categorizes bowel movements into 7 types, from Type 1 (separate hard lumps, like nuts; hard to pass) to Type 7 (watery, no solid pieces, entirely liquid).~Diarrhoea was defined at least one BSFS score >= 6 for the given week."|Baseline and week 12|Intent-to-treat population|||percentage of participants|||Number
2562822|NCT02633020|Secondary|Number of Weekly Bowel Movements at Baseline and Week 12|Participants were asked to record every bowel movement during the study using an electronic diary. If no bowel movements were experienced by the participant on any given day, the participant was required to document this in the diary.|Baseline and week 12|The intent-to-treat population consisted of all randomized participants who had received at least one dose of the study drug.|||bowel movements per week||Standard Deviation|Mean
2562823|NCT02633020|Secondary|Percent Change From Baseline in Total Intraepithelial Lymphocyte Count at Week 12|Small bowel biopsies were performed at baseline and week 12; histological assessments were performed by a blinded central pathologist. The total IEL count is the density of IELs vs intestinal epithelial cells measured by immunohistochemistry.|Baseline and week 12|The per protocol population|||percent change||Standard Error|Least Squares Mean
2562824|NCT02633020|Secondary|Percentage of Participants With Improvement in Marsh Score at Week 12|"The Marsh classification system describes the stages of damage in the small intestine as seen under a microscope, with possible values of 0, 1, 2, 3a, 3b, or 3c. A score of 0 (best score) indicates that the intestinal lining is normal and celiac disease highly unlikely, a score of 3c (worst score) indicates increased intraepithelial lymphocytes, increased crypt hyperplasia and complete villi atrophy.~Improvement is defined as a lower grade on the Marsh score scale compared to baseline."|Baseline and week 12|Per protocol population|||percentage of participants|||Number
2562825|NCT02633020|Secondary|Percent Change From Baseline in Villous Height to Crypt Depth (VH:CD) Ratio|"Villi are the small fingerlike projections that line the small intestine and promote nutrient absorption and are often shortened in patients with celiac disease. Crypts are grooves between the villi that are often elongated in patients with celiac disease. A decreased VH:CD ratio indicates worsening disease and increases in the VH:CD ratio indicate an improvement in the histology of intestinal mucosa (Histological Response).~Small bowel biopsies were performed at baseline and week 12; histological assessments were performed by a blinded central pathologist."|Baseline and week 12|Per protocol population|||percent change||Standard Error|Least Squares Mean
2562826|NCT02633020|Secondary|Percent Change From Baseline in the Percentage of Aberrant Intestinal Intraepithelial Lymphocytes With Respect to All Intestinal Epithelial Cells|Percent change from baseline in the percentage of aberrant intestinal IELs with respect to intestinal epithelial cells (Immunological Response 2) is a composite endpoint calculated by multiplying the percent of aberrant IEL versus total IELs (per flow cytometry) by the percent of total IEL versus intestinal epithelial cells as assessed by immunohistochemistry.|Baseline and week 12|The per protocol (PP) population included participants who received study drug and provided evaluable data for efficacy analysis, excluded non-evaluable participants and those with major protocol deviations. Participants with atypical RCD-II were also excluded from analyses of Immunological Response 2.|||percent change||Standard Error|Least Squares Mean
2562827|NCT02633020|Primary|Percent Change From Baseline in the Percentage of Aberrant Intestinal Intraepithelial Lymphocytes With Respect to All Intraepithelial Lymphocytes|"The primary endpoint in this study was the change form baseline in the percentage of aberrant intestinal intraepithelial lymphocytes (IELs) with respect to total IELs, as assessed by flow cytometry (Immunological Response 1).~Intraepithelial lymphocytes (IELS) are white blood cells interspersed between epithelial cells of the small and large intestine where they function to preserve the integrity of the mucosal barrier by protecting the epithelium against pathogen or immune-induced pathology. In refractory coeliac disease type 2, aberrant intraepithelial lymphocytes make up 20% or more of total intraepithelial lymphocytes. Aberrant IELs were defined by flow cytometry as surface cluster of differentiation (CD)3-negative, intracellular CD3-positive IELs (sCD3-, icCD3+)."|Baseline and week 12|The per protocol (PP) population included participants who received study drug and provided evaluable data for efficacy analysis, excluded non-evaluable participants and those with major protocol deviations. Participants with atypical RCD-II were also excluded from analyses of Immunological Response 1.|||percent change||Standard Error|Least Squares Mean
2562828|NCT02632838|Other Pre-specified|Hospital Admissions for Hypertension Related Illnesses|Data obtained from patients' electronic health records. Total number of hospital admissions for hypertension related illnesses were compared at baseline and 6 months.|6 months|All study sample were analyzed|||hospital admissions|||Number
2562829|NCT02632838|Other Pre-specified|Patient Self-efficacy|Medication Adherence Self-Efficacy Scale (MASES) were used to measure the patient self-efficacy in adhering to prescribed hypertension medications. MASES was developed to measure several aspects of self-efficacy, including adherence to prescribed medication for the management of hypertension. The MASES includes 26 items rated on a 3-point Likert scale (1= Not at all Sure, 2= Somewhat Sure, and 3= Very Sure). The range of this scale is from 26 to 78. A total mean score is calculated by averaging responses to all items. Higher scores indicate a great level of self-efficacy The survey scores compared at baseline and 6 months.|baseline and 6-month|All study sample were analyzed.|||units on a scale||Standard Deviation|Mean
2562938|NCT02631746|Primary|Duration of Response|Summarized using descriptive statistics. Binomial proportions and their 90% confidence intervals will be used to estimate the response rates of therapy. The Kaplan-Meier method will be used to evaluate the response duration.|1 year|Duration of response cannot be calculated because of no responders.||||||
2562830|NCT02632838|Other Pre-specified|Health-Related Quality of Life|"Health-Related Quality of Life were measured by 36-Item Short Form Health Survey (SF-36).~The SF-36 consisted of the sum scores of eight subscales (physical functioning, physical role limitations, mental health, emotional role limitations, social functioning, vitality, pain, and general health perceptions), which are the weighted sums of the questions in each sections. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The eight subscales were summarized into two composite scores (physical and mental quality of life). Various studies demonstrated that the reliability of the SF-36 have exceeded 0.80 The SF-36 scores compared at baseline and 6-month later"|baseline and 6-month|All study sample data were analyzed.|||units on a scale||Standard Deviation|Mean
2562831|NCT02632838|Secondary|Blood Pressure Monitoring Adherence|"BP monitoring adherence were used to measure hypertension status monitoring experiences BP monitoring adherence for the mHealth group was calculated by dividing the total number of times iHealth BP-7 was used to measure BP by the total number of expected times it should have been used (one BP measurement performed every day for 6 months).~BP monitoring adherence for the standard follow-up group was calculated by dividing the total number of office visits to measure BP by the total number of expected visits (one office BP measurement every week for 6 months)."|6 months|All study sample were analyzed.|||adherence|||Number
2562832|NCT02632838|Primary|Blood Pressure (BP) Change|"BP change defined as monthly average BP in both systolic and diastolic blood pressure decrease. BP decline were expected as early as 3 month of intervention and kept to decreasing over 6 month period.~For the mHealth group: iHealth's MyVitals BP data were collected by a project research assistant every week. Data were aggregated, and an average of the BP readings recorded at baseline, 3-month and 6-month were used for data analysis.~For the standard follow up group, participants' BP was measured in an upright seated position with feet flat on the floor while being at rest for at least 5 minutes. During each week's office visit, participants were measured twice or more, separated by two minutes in each arm. The Welch Allyn Spot Vital Signs LXi electronic blood pressure monitor was utilized for this group. Data were aggregated, and an average of the BP readings recorded at baseline, 3-month and 6-month were used for data analysis."|baseline, 3 monthly intervals over 6 months of follow up|All study sample were analyzed.|||mm Hg||Standard Deviation|Mean
2562833|NCT02632812|Secondary|Number of Adverse Events||60 days||||adverse events|||Number
2562834|NCT02632812|Primary|Prostaglandin Level (PGE2 Quantification)|Tissue prostaglandin concentration quantified by enzyme-linked immunosorbent assay (ELISA) using Cayman Chemical Monoclonal Prostaglandin E2 EIA Kit (item number 514010)|8 days||||pg/mL (mean tissue PGE2 concentration)||95% Confidence Interval|Mean
2562835|NCT02632812|Primary|Presence of H. Pylori by Biopsy|Giemsa stain was used to diagnose H. pylori (positive = presence of H. pylori)|8 days||||participants|||Number
2562836|NCT02632812|Primary|Intragastric pH||8 days|Intragastric PH measurement was not performed and for this reason it will not be available.||||||
2562837|NCT02632812|Primary|Histopathological Score|"Histopathologic grade score developed for microscopic injury evaluation 0 = Normal gastric mucosa or mild chronic inflammation~= Chronic gastritis without activity~= Chronic gastritis with activity on antrum~= Chronic gastritis with activity on the body~= Chronic gastritis with activity on antrum and on the body"|8 days||||Histopathologic grade score||Full Range|Median
2562838|NCT02632812|Primary|Endoscopic Score - Modified Lanza Score|"Modified Lanza score according to gastroduodenal mucosal injury:~0 = No hemorrhage or erosion observed~= One or two hemorrhages or erosions observed in one gastric area~= Three to five hemorrhages or erosions observed in one gastric area~= Hemorrhages or erosions observed in two gastric areas, six or more hemorrhages or erosions observed in one gastric area, with the total number not exceeding ten in the entire stomach~= Hemorrhages or erosions observed in three or more gastric areas; eleven or more hemorrhages or erosions observed widely in the entire stomach~= Ulcer"|8 days||||Modified Lanza score||Full Range|Median
2562839|NCT02632812|Primary|Endoscopic Score - Cryer Score|"Cryer score according to gastroduodenal mucosal injury:~0 = Normal or erythema~= Any amount of submucosal hemorrhage or edema without erosions~= 1 erosion +- submucosal hemorrhage or edema~= 2-4 erosions +- submucosal hemorrhage or edema~= 5 or more erosions and/or a single ulcer +- submucosal hemorrhage or edema~= Multiple ulcers +- submucosal hemorrhage or edema - Ulcer"|8 days|All recruited volunteers completed the trial.|||Cryer score||Full Range|Median
2562840|NCT02632786|Secondary|Hepatic Best Response|Alkaline Phosphatase response (Response or Non-Response [Stable, Progression]) from baseline through 12 months of treatment in subjects with hepatic involvement|Baseline through 12 months of treatment|Hepatic Evaluable Population|||Participants|||Count of Participants
2562841|NCT02632786|Secondary|NT-proBNP Slope|Rate of change in NT-proBNP (ng/L per infusion). Estimates of the intercept, slope, SE, and associated 95% CI for each treatment group, and the NEOD001 and placebo group difference comparisons are estimated using a general linear mixed effects model. The model fits a random intercept and slope for each subject and includes fixed effects for treatment group, time, treatment group by time interaction, IWRS stratification factors (hematologic response to first-line therapy: CR/VGPR, PR and NT-proBNP <1800 ng/L, ≥1800 ng/L), and an unstructured covariance structure to model the within-subject errors. Time is represented in months as a continuous variable and includes all scheduled time points, including baseline. The p-value is associated with the visit by treatment group interaction term.|Baseline through 12 months of treatment|ITT population|||ng/L per infusion||95% Confidence Interval|Mean
2562842|NCT02632786|Secondary|NIS-LL Total Score|Change in Neuropathy Impairment Score-Lower Limb (NIS-LL) Total Score in subjects with peripheral nerve involvement. NIS-LL is a scoring system graduated from 0 points to a maximum of 88 points (the absence of all motor, sensory, and reflex activity in the lower extremities). The scale is an additive of all deficits (64 potential points for muscle strength, 8 points for reflexes, and 16 points for sensory function) in the lower extremities. A score of 0 is normal and score of 88 is total impairment.|Baseline to 12 months of treatment|Peripheral Neuropathy Evaluable Population|||score on a scale||95% Confidence Interval|Least Squares Mean
2562939|NCT02631746|Primary|Tumor Response, Evaluated Using the New International Criteria Proposed by the Revised Response Evaluation Criteria in Solid Tumors Guideline (Version 1.1)|Summarized using descriptive statistics. Binomial proportions and their 90% confidence intervals will be used to estimate the response rates of therapy.|1 year||||Participants|||Count of Participants
2562843|NCT02632786|Secondary|Number of Participants With Renal Best Response and Non-Response|"Proteinuria and estimated Glomerular Filtration Rate (eGFR) response (Response or Non-Response [Stable, Progression]) from baseline through 12 months of treatment in subjects with renal involvement. Renal best response, as assessed by proteinuria, is defined as the most favorable category among response (ie, ≥30% decrease from baseline or <0.5 g/24 hours postbaseline result if subject does not meet criteria for progression), stable (ie, neither response nor progression), and progression (ie, ≥25% decrease in eGFR from baseline) across all visits after the first infusion of study drug up to and through the end of the study. Subjects are considered non-responders until a response is achieved. Assessments that qualify as both a response and progression are counted as progression.~Non-response is defined as either stable or progression."|Baseline through 12 months of treatment|Renal Evaluable Population|||Participants|||Count of Participants
2562844|NCT02632786|Secondary|6MWT Distance|Change in 6 Minute Walk Test (6MWT) Distance (meters)|Baseline to 12 months of treatment|ITT Population|||meters||Inter-Quartile Range|Median
2562845|NCT02632786|Secondary|SF-36v2 PCS Score|Change in Short Form-36 (SF-36 version 2) questionnaire Physical Component Summary [PCS] Score. PCS scores are calculated based on responses to specific Short Form-36 (version 2) questions using a weight scoring method. The lower the PCS score the more disability, the higher the score the less disability. A score of 50 is the mean in the US General Population and the standard deviation is 10. Minimum is 0 and maximum value is 100.|Baseline to 12 months of treatment|ITT population|||score on a scale||95% Confidence Interval|Least Squares Mean
2562846|NCT02632786|Primary|Number of Participants With Cardiac Response and Non-Response|N-terminal pro-brain natriuretic peptide (NT-proBNP ) best response (Response or Non-Response [Stable, Progression]) from baseline through 12 months of treatment. Cardiac best response, as assessed by NT-proBNP alone, is defined as the most favorable category among response (ie, decrease in NT-proBNP from baseline of >30% and >300 ng/L), stable (ie, neither response nor progression), and progression (ie, increase in NT-proBNP from baseline of >30% and >300 ng/L) across all visits after the first infusion of study drug up to and through the end of the study. Subjects are considered non-responders until a response is achieved. Non-response is defined as either stable or progression.|Baseline through 12 months of treatment|ITT population|||Participants|||Count of Participants
2562847|NCT02632526|Secondary|Pharmacodynamic Analysis by ex Vivo Stimulation of LTB4 Production Using Calcium Ionophore for Part B - Amorphous Suspension|To assess the change from baseline in the ex vivo stimulated LTB4 production using calcium ionophore in venous blood samples following multiple administration of AZD5718 Amorphous suspension (Part B only)|Admission, predose and 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose|All subjects who received at least 1 dose of AZD5718 or placebo and who had at least 1 pre-dose and one post-dose measurement of stimulated LTB4 and who had no major protocol deviations thought to impact on the analysis of the PD data.|||Nanogram/liter (ng/L)||Full Range|Median
2562848|NCT02632526|Secondary|Pharmacodynamic Analysis by ex Vivo Stimulation of Leukotriene B4 (LTB4) Production Using Calcium Ionophore for Part A -Amorphous and Crystalline Suspension|To assess the change from baseline in the ex vivo stimulated LTB4 production using calcium ionophore in venous blood samples following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)|Admission to 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose (Part A only)|All subjects who received at least 1 dose of AZD5718 or placebo and who had at least 1 pre-dose and one post-dose measurement of stimulated LTB4 and who had no major protocol deviations thought to impact on the analysis of the PD data.|||Nanogram/liter (ng/L)||Full Range|Median
2562849|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of Renal Clearance (CLR) Following a Multiple Daily Doses Administration of AZD5718 Amorphous Suspension (Part B Day 9)|To assess the urine PK parameter (CLR) after a single administration of AZD5718 Amorphous suspension in Part B Day 9|Part B only, Day 9 at pooled 3 hour intervals until 24 hours post-dose|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||Liter/hour||Standard Deviation|Mean
2562850|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of Percentage of Dose Excreted Unchanged Into the Urine From 0 to 24 Hours (Cumfe0-24) Following a Multiple Daily Doses Administration of AZD5718 Amorphous Suspension (Part B Day 9)|To assess urine PK parameter (Cumfe0-24) estimated by dividing Ae(0-last) by dose after a single administration of AZD5718 Amorphous suspension in Part B Day 9|Part B only, Day 9 at pooled 3 hour intervals until 24 hours post-dose|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||Percentage of Dose Excreted||Standard Deviation|Mean
2562851|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of Cumulative Amount of Analyte Excreted From 0 to 24 Hours (CumAe0-24) Following a Multiple Daily Doses Administration of AZD5718 Amorphous Suspension (Part B Day 9)|To assess the urine PK parameter (CumAe0-24) after a single administration of AZD5718 Amorphous suspension in Part B Day 9|Part B only, Day 9 at pooled 3 hour intervals until 24 hours post-dose|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||nmol||Standard Deviation|Mean
2562852|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of Renal Clearance (CLR) Following a Single Administration of AZD5718 Amorphous and Crystalline Suspension (Part A)|To assess the urine PK parameter (CLR) after a single administration of AZD5718 Amorphous suspension in Part A|Part A pre-dose and pooled intervals up to 24 hours post-dose|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||Liter/hour||Standard Deviation|Mean
2562853|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of Percentage of Dose Excreted Unchanged Into the Urine From 0 to 24 Hours (Cumfe0-24) Following a Single Administration of AZD5718 Amorphous and Crystalline Suspension (Part A)|To assess urine PK parameter (Cumfe0-24) estimated by dividing Ae(0-last) by dose after a single administration of AZD5718 Amorphous suspension in Part A|Part A pre-dose and pooled intervals up to 24 hours post-dose|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||Percentage of Dose Excreted||Standard Deviation|Mean
2562854|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of Cumulative Amount of Analyte Excreted at the Last Sampling Interval (CumAe0-24) Following a Single Administration of AZD5718 Amorphous and Crystalline Suspension (Part A)|To assess urine PK parameter (CumAe0-24) after a single administration of AZD5718 Amorphous suspension in Part A|Part A pre-dose and pooled intervals up to 24 hours post-dose|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||nmol||Standard Deviation|Mean
2562855|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of the Effect of Food Following Administration of 180 mg AZD5718 With Food (Part B Day 9) and Fasted (Part B Day 10)|The effect of food was evaluated by the assessment of the PK parameter(tmax) following multiple daily doses of 180 mg AZD5718 under fasted condition (Part B Day 10) and immediately following a high-fat breakfast (Part B Day 9)|At Day 9 and Day 10 (Part B only)|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||Hours||Full Range|Median
2562856|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of the Effect of Food Following Administration of 180 mg AZD5718 With Food (Part B Day 9) and Fasted (Part B Day 10)|The effect of food was evaluated by the assessment of the PK parameter (AUC(0-t) following multiple daily doses of 180 mg AZD5718 under fasted condition (Part B Day 10) and immediately following a high-fat breakfast (Part B Day 9)|At Day 9 and Day 10 (Part B only)|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2562857|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of the Effect of Food Following Administration of 180 mg AZD5718 With Food (Part B Day 9) and Fasted (Part B Day 10)|The effect of food was evaluated by the assessment of the PK parameter (Cmax) following multiple daily doses of 180 mg AZD5718 under fasted condition (Part B Day 10) and immediately following a high-fat breakfast (Part B Day 9)|At Day 9 and Day 10 (Part B only)|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2562858|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of the Temporal Change Parameter in Systemic Exposure (TCP) for Part B (Amorphous Suspension) Under Fasted Condition|"To assess rate and extent of absorption of AZD5718 by assessment of the temporal change parameter in systemic exposure (TCP) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B).~TCP calculated as AUCτDay10/AUCDay 1 and presented values for Day 10"|At Day 10 (Part B only)|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||Ratio, no units||Full Range|Mean
2562859|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of the Accumulation Ratio for Cmax (RAC Cmax) for Part B (Amorphous Suspension) Under Fasted Condition|To assess the rate and extent of absorption of AZD5718 by evaluation of accumulation ratio for Cmax (RAC Cmax) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B). Accumulation ratio calculated as Cmax Day 10/Cmax Day 1 (first dose) for Part B under fasted condition.|Day 1 and Day 9 (Part B only)|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||Ratio, no units||Full Range|Mean
2562860|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of the Accumulation Ratio for AUC(0-τ) (RAC AUC(0-τ)) for Part B - Amorphous Suspension|To assess rate and extent of absorption of AZD5718 by assessment of the Rate and extent of absorption of AZD5718 by assessment of accumulation ratio for AUC(0-τ) (RAC AUC(0-τ)) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B) Accumulation ratio calculated as AUC0-τ Day 10/AUC0-τ Day 1 (first dose) for Part B under fasted condition and presented values for Day 10|Day 1 and Day 9 (Part B only)|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||Ratio||Full Range|Mean
2562861|NCT02632526|Secondary|To Evaluate the Relative Bioavailability Between the Amorphous and Crystalline Form of AZD5718 (Part A) by Assessment of Cmax for Part A - Amorphous and Crystalline Suspension|"To assess the relative bioavailability by Cmax between the cohort receiving the crystalline suspension and the corresponding data from the cohort receiving the same dose of the amorphous suspension (Part A only). Crystalline suspension was compared to the reference amorphous suspension.~Note: Geometric mean ratios for crystalline/amorphous suspensions were calculated"|At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||nmol/L||90% Confidence Interval|Geometric Mean
2562862|NCT02632526|Secondary|To Evaluate the Relative Bioavailability Between the Amorphous and Crystalline Form of AZD5718 (Part A) by Assessment of AUC for Part A - Amorphous and Crystalline Suspension|"To assess the relative bioavailability by AUC between the cohort receiving the crystalline suspension and the corresponding data from the cohort receiving the same dose of the amorphous suspension (Part A only). Crystalline suspension was compared to the reference amorphous suspension.~Note: Geometric mean ratios for crystalline/amorphous suspensions were calculated"|At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose)|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||h*nmol/L||90% Confidence Interval|Geometric Mean
2562940|NCT02631746|Primary|Incidence of Adverse Events of Nivolumab, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Toxicity by grade will be summarized using descriptive statistics. The incidence of toxicities will be estimated using the binomial proportion and its 90% confidence interval.|1 year||||Participants|||Count of Participants
2562863|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of the Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) for Part A - Amorphous and Crystalline Suspension|To assess rate and extent of absorption of AZD5718 by assessment of the apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)|At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose)|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||Liters||Standard Deviation|Mean
2562864|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of the Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (CL/F) for Part B - Amorphous Suspension|To assess rate and extent of absorption of AZD5718 by assessment of the Rate and extent of absorption of AZD5718 by assessment of CL/F estimated as dose divided by AUC (for Day 1 only) and dose divided by AUCτ on Day 10 following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B)|Day 1 and Day 10 of Part B|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||Liter/Hour||Standard Deviation|Mean
2562865|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of the Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (CL/F) for Part A - Amorphous and Crystalline Suspension|To assess rate and extent of absorption of AZD5718 by assessment of the apparent total body clearance after extravascular administration estimated as dose divided by AUC (CL/F) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)|At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||Liters/Hours||Standard Deviation|Mean
2562866|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of the Half-life Associated With Terminal Slope of a Semi-logarithmic Plasma Concentration-time Curve (t½λz) for Part B - Amorphous Suspension|To assess the rate and extent of absorption of AZD5718 by evaluation of the half-life associated with terminal slope of a semi-logarithmic plasma concentration-time curve (t½λz) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B)|Day 1 and Day 10 (Part B only)|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||Hours||Standard Deviation|Mean
2562867|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of the Half-life Associated With Terminal Slope of a Semi-logarithmic Plasma Concentration-time Curve (t½λz) for Part A - Amorphous and Crystalline Suspension|To assess Rate and extent of absorption of AZD5718 by assessment of the half-life associated with terminal slope of a semi-logarithmic plasma concentration-time curve (t½λz) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)|At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||Hours||Standard Deviation|Mean
2562868|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of the Time to Reach the Observed Maximum Plasma Concentration (Tmax) for Part B - Amorphous Suspension|To assess the rate and extent of absorption of AZD5718 by evaluation of the time to reach the observed maximum plasma concentration (tmax) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B)|Day 1, Day 9 and Day 10 (Part B only)|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||Hours||Full Range|Median
2562869|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of the Time to Reach the Observed Maximum Plasma Concentration (Tmax) for Part A - Amorphous and Crystalline Suspension|To assess the time to reach the observed maximum plasma concentration (tmax) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)|At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||Hours||Full Range|Median
2562870|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of the Observed Maximum Plasma Concentration (Cmax) for Part B - Amorphous Suspension|To assess the rate and extent of absorption of AZD5718 by evaluation of the observed maximum plasma concentration (Cmax) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B)|Day 1, Day 9 and Day 10 (Part B only)|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2562871|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of the Observed Maximum Plasma Concentration (Cmax) for Part A - Amorphous and Crystalline Suspension|To assess observed maximum plasma concentration (Cmax) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)|At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2562941|NCT02631577|Secondary|Number of Participants Positive for Anti-therapeutic Antibodies (ATAs) to Atezolizumab|The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year|From Baseline up to 30 months||2021-11-30|11/2021||||
2562872|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under the Plasma Concentration-curve Over the Dosing Interval (AUC(0-τ)) for Part B - Amorphous Suspension|To assess the rate and extent of absorption of AZD5718 by evaluation of the area under the plasma concentration-curve over the dosing interval (AUC(0-τ)) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B)|Day 1, Day 9 and Day 10 of Part B|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2562873|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under the Plasma Concentration-curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-last)) for Part A - Amorphous and Crystalline Suspension|To assess area under the area under the plasma concentration-curve from time zero to the time of last quantifiable concentration (AUC(0-last)) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)|At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2562874|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC) for Part B - Amorphous Suspension|To assess the rate and extent of absorption of AZD5718 by evaluation of the area under plasma concentration-time curve from time zero extrapolated to infinity (AUC) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B)|Day 1 of Part B|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2562875|NCT02632526|Secondary|Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under the Plasma Concentration-curve From Time Zero Extrapolated to Infinity (AUC) for Part A - Amorphous and Crystalline Suspension|To assess area under the concentration-time curve from time zero extrapolated to infinity and was estimated by AUC(0-last) + Clast/λz (Clast - the last observed quantifiable concentration) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)|At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)|All subjects in the safety analysis set for whom at least one dose of AZD5718 and who had evaluable PK data, with no major protocol deviations thought to impact on the analysis of the PK data.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2562876|NCT02632526|Primary|Safety and Tolerability of AZD5718 by Assessment of the Number of Participants With Adverse Events Following Oral Administration of SAD (Part A) and MAD (Part B).|To assess the safety and tolerability of AZD5718 following oral administration of SAD (Part A) and MAD (Part B).|From screening to last followup visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B)|All randomized subjects who received at least 1 dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||Participants|||Number
2562877|NCT02632110|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|12 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562878|NCT02632110|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|8 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562879|NCT02632110|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|2 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562880|NCT02632110|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24-48 hours after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562881|NCT02632110|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline||||AK Fields|AK Fields||Count of Units
2562882|NCT02632110|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|12 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562883|NCT02632110|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|8 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562884|NCT02632110|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|2 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562885|NCT02632110|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24-48 hours after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562886|NCT02632110|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline||||AK Fields|AK Fields||Count of Units
2562887|NCT02632110|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|12 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562888|NCT02632110|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|8 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562889|NCT02632110|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|2 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562890|NCT02632110|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|24-48 Hours after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562891|NCT02632110|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 minutes after PDT #1||||AK Fields|AK Fields||Count of Units
2562892|NCT02632110|Other Pre-specified|Stinging/Burning|"﻿Immediately after PDT, the most intensive, acute perception of Stinging/Burning DURING treatment will be recorded.~STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable"|During PDT #1||||AK Fields|AK Fields||Count of Units
2562894|NCT02632110|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|12 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562895|NCT02632110|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|8 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562896|NCT02632110|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|2 weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562897|NCT02632110|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24-48 hours after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562898|NCT02632110|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 minutes after PDT #1||||AK Fields|AK Fields||Count of Units
2562899|NCT02632110|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline||||AK Fields|AK Fields||Count of Units
2562900|NCT02632110|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|12 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562901|NCT02632110|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|8 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562902|NCT02632110|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|2 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562903|NCT02632110|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24-48 hours after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2564040|NCT02614469|Secondary|Safety Assessment (Vital Signs)|Number of participants with clinically significant findings in vital signs by investigator after study drug administration.|Up to 10 days after first study drug administration at Day 1 of Period 1||||participants|||Number
2562904|NCT02632110|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 minutes after PDT #1||||AK Fields|AK Fields||Count of Units
2562905|NCT02632110|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline|split face|||AK Fields|AK Fields||Count of Units
2562906|NCT02632110|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|12 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562907|NCT02632110|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|8 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562908|NCT02632110|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|2 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562909|NCT02632110|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|24-48 hours after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562910|NCT02632110|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Baseline||||AK Fields|AK Fields||Count of Units
2562911|NCT02632110|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|12 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562912|NCT02632110|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|8 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562913|NCT02632110|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|2 Weeks after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2564062|NCT02614287|Secondary|Serum Concentrations of Galcanezumab|Serum Concentrations of Galcanezumab.|Month 12|All randomized participants with measurable serum concentrations at month 12.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2562914|NCT02632110|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24-48 hours after PDT #1|split-face. Number of participants and units analyzed is based on observed data at this visit. Number of subjects with observed data at this visit may differ from number of subjects at baseline or completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562915|NCT02632110|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline|split-face|||AK Fields|AK Fields||Count of Units
2562916|NCT02632110|Secondary|Percent Change|Percent change in the total AK number as compared with Baseline|Baseline and Week 12|split-face|||percent change|AK Fields|Standard Deviation|Mean
2562917|NCT02632110|Secondary|Percent Change|Percent change in the total AK number as compared with Baseline|Baseline and Week 8|split face. Week 8 number of participants and units analyzed is based on observed data at that Visit. Number of subjects at Week 8 may differ from number of subjects completing study as noted in participant flow.|||percent change|AK Fields|Standard Deviation|Mean
2562918|NCT02632110|Secondary|Baseline AKCR|AK clearance rate for only those lesions present at Baseline|Baseline and Week 12|split-face|||percentage cleared|AK Fields|Standard Deviation|Mean
2562919|NCT02632110|Secondary|Baseline AKCR|AK clearance rate (AKCR) for only those lesions present at Baseline|Baseline and Week 8|split-face. Week 8 number of participants and units analyzed is based on observed data at that Visit. Number of subjects at Week 8 may differ from number of subjects completing study as noted in participant flow.|||percentage cleared|AK Fields|Standard Deviation|Mean
2562920|NCT02632110|Secondary|Subject Satisfaction Score|"Subject satisfaction score~= Excellent (very satisfied)~= Good (moderately satisfied)~= Fair (slightly satisfied)~= Poor (not satisfied at all)"|Week 12|split-face.|||AK Fields|AK Fields||Count of Units
2562921|NCT02632110|Secondary|Complete Clearance Rate|Number of AK Fields with 0 Lesions|Week 8|split-face. Week 8 number of participants and units analyzed is based on observed data at that Visit. Number of subjects at Week 8 may differ from number of subjects completing study as noted in participant flow.|||AK Fields|AK Fields||Count of Units
2562922|NCT02632110|Primary|Complete Clearance Rate|Number of AK Fields with 0 lesions|Week 12|Split-face study|||AK Fields|AK Fields||Count of Units
2562923|NCT02631954|Secondary|t1/2|The blood sampleing coleected from the subjects was analyzed and result was obtained.|0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs||||hr||Standard Deviation|Mean
2562924|NCT02631954|Secondary|Kel (Elemination Rate Constant)|The blood sampleing coleected from the subjects was analyzed and result was obtained.|0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs||||1/hr||Standard Deviation|Mean
2562925|NCT02631954|Secondary|AUCt/AUCinf|The blood sampleing coleected from the subjects was analyzed and result was obtained.|0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs||||Ratio||Standard Deviation|Mean
2562926|NCT02631954|Secondary|AUCinf of Voriconazole|The blood sampleing coleected from the subjects was analyzed and result was obtained.|0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs||||hr*ng/mL||Standard Deviation|Mean
2562927|NCT02631954|Secondary|Tmax of Voriconazole|The blood sampleing coleected from the subjects was analyzed and result was obtained.|0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs||||hr||Standard Deviation|Mean
2562928|NCT02631954|Primary|AUCt of Voriconazole|The blood sampleing coleected from the subjects was analyzed and result was obtained.|0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs||||hr*ng/mL||Standard Deviation|Mean
2562929|NCT02631954|Primary|Cmax of Voriconazole|The blood sampleing coleected from the subjects was analyzed and result was obtained.|0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs||||ng/mL||Standard Deviation|Mean
2562930|NCT02631772|Secondary|Hemoglobin Levels|Change in hemoglobin levels over the course of the study|Week 4, Week 8, Week 12, Week 16||||g/dL||Standard Deviation|Mean
2562931|NCT02631772|Secondary|Number of Participants With Virologic Failure|Number of participants who had a nonresponse to treatment or a relapse of disease under study.|12 weeks||||Participants|||Count of Participants
2562932|NCT02631772|Primary|Treatment Efficacy|Treatment efficacy, defined as the percentage of patients achieving sustained virologic response 12 (SVR12) weeks after completing the antiviral regimen|12 Weeks||||% of participants|||Number
2562933|NCT02631746|Secondary|Immune Cell Numbers|Measured from blood and tissue samples.|1 year|Post-treatment data not available because no patients made it to Cycle 3 Day 1.||||||
2562934|NCT02631746|Secondary|HTLV-1 Specific Cytotoxic T Lymphocytes (CTLs)|Measured from PBMC samples.|1 year|Post-treatment data not available because no patients made it to Cycle 3 Day 1.||||||
2562935|NCT02631746|Secondary|HTLV-1 Clonality|Measured from peripheral blood mononuclear cell (PBMC) samples.|1 year|Post-treatment data not available because no patients made it to Cycle 3 Day 1.||||||
2562936|NCT02631746|Secondary|Time on the Viral Load Measurements|Analysis of variance methods will be used to evaluate the effects of treatment and time on the viral load measurements, as well as measurements of viral transcripts. A proportional hazards analysis with viral load measures as time dependent covariates will be used to evaluate the effects of these measures on duration of response.|1 year|Post-treatment data not available because no patients made it to Cycle 3 Day 1.||||||
2562937|NCT02631746|Secondary|Effects of Treatment|Analysis of variance methods will be used to evaluate the effects of treatment.|1 year|Post-treatment data not available because no patients made it to Cycle 3 Day 1.||||||
2563704|NCT02621060|Primary|Total Insulin Secretion|After intervention. Total insulin secretion was calculated with the Insulinogenic index (Δ ABC insulin / Δ ABC glucose).|Week 12.|3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.|||Unitless||Standard Deviation|Mean
2562942|NCT02631577|Secondary|Number of Participants Positive for Human Anti-human Antibodies (HAHA) to Obinutuzumab|The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year|From Baseline up to 30 months||2021-11-30|11/2021||||
2562943|NCT02631577|Secondary|Serum Concentration of Lenalidomide (ng/mL)|The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; HR = Hour|From Baseline up to 30 months||2021-11-30|11/2021||||
2562944|NCT02631577|Secondary|Serum Concentration of Atezolizumab (mcg/mL)|The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year|From Baseline up to 30 months||2021-11-30|11/2021||||
2562945|NCT02631577|Secondary|Serum Concentration of Obinutuzumab (mcg/mL)|The following abbreviations apply in the table: Ind C = Induction Cycle; D = Day; Maint M = Maintenance Month; TRTC = Study Drug Completion or Early Discontinuation; PK FU = Pharmacokinetics and Immunogenicity Follow-up; YR = Year|From Baseline up to 30 months||2021-11-30|11/2021||||
2562946|NCT02631577|Secondary|Number of Participants With Dose-limiting Toxicities (DLTs) During Cycle 2 of Study Treatment|Does limiting toxicity (DLT) is defined as any one of the following events occurring during Cycle 2 of treatment and assessed by the investigator as related to study treatment: - Adverse event of any grade that leads to a delay of more than 14 days at the start of the next treatment cycle; - Hematologic adverse events (neutropenia, thrombocytopenia); - Non-hematologic adverse event, except IRRs, diarrhea, nausea or vomiting|Day 1 - Day 28 of second cycle|The Safety Evaluable Population included participants who received at least one dose of any study treatment.|||Number of Participants|||Number
2562947|NCT02631577|Secondary|Percentage of Participants With Adverse Events and Serious Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|30 months||2021-11-30|11/2021||||
2562948|NCT02631577|Secondary|Percentage of Participants With Objective Response (CR or PR) During the Study||30 months||2021-11-30|11/2021||||
2562949|NCT02631577|Secondary|Percentage of Participants With Objective Response (CR or PR) at EOI|Objective response was evaluated through use of PET-CT scans or CT scans alone, using the Lugano 2014 or modified Lugano 2014 criteria. Response was determined by the IRC and by the Investigator.|6 months (up to CCOD of 23 October 2018)|As no DLTs were observed, the dose of 20 mg lenalidomide was confirmed as the recommended Phase II dose (RP2D) for lenalidomide. Only participants who received lenalidomide induction at the 20 mg RP2D were included in the Efficacy Evaluable population, hence participants in the Atezo-G-L 15 mg arm were not included in the efficacy analysis.|||Percentage of Participants||90% Confidence Interval|Number
2562950|NCT02631577|Secondary|Percentage of Participants Achieving CR at EOI, as Determined by the IRC and Investigator Using Lugano 2014 Criteria|CR was evaluated through use of CT scans, using the Lugano 2014 criteria. Response was determined by the IRC and by the Investigator.|6 months (up to CCOD of 23 October 2018)|As no DLTs were observed, the dose of 20 mg lenalidomide was confirmed as the recommended Phase II dose (RP2D) for lenalidomide. Only participants who received lenalidomide induction at the 20 mg RP2D were included in the Efficacy Evaluable population, hence participants in the Atezo-G-L 15 mg arm were not included in the efficacy analysis.|||Percentage of Participants||90% Confidence Interval|Number
2562951|NCT02631577|Secondary|Percentage of Participants Achieving CR at EOI, as Determined by the Investigator Using Modified Lugano 2014 Criteria|CR was evaluated through use of PET-CT scans, using the Modified Lugano 2014 criteria. Response was determined by the Investigator.|6 months (up to CCOD of 23 October 2018)|As no DLTs were observed, the dose of 20 mg lenalidomide was confirmed as the recommended Phase II dose (RP2D) for lenalidomide. Only participants who received lenalidomide induction at the 20 mg RP2D were included in the Efficacy Evaluable population, hence participants in the Atezo-G-L 15 mg arm were not included in the efficacy analysis.|||Percentage of Participants||90% Confidence Interval|Number
2562952|NCT02631577|Primary|Percentage of Participants Achieving Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria|Complete response (CR) was evaluated through use of PET-CT scans, using the Modified Lugano 2014 criteria. Response was determined by the IRC.|6 months (up to clinical cut-off date (CCOD) of 23 October 2018)|As no DLTs were observed, the dose of 20 mg lenalidomide was confirmed as the recommended Phase II dose (RP2D) for lenalidomide. Only participants who received lenalidomide induction at the 20 mg RP2D were included in the Efficacy Evaluable population, hence participants in the Atezo-G-L 15 mg arm were not included in the efficacy analysis.|||Percentage of Participants||90% Confidence Interval|Number
2562953|NCT02631551|Primary|Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.|Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).|14 days|The Full Analysis Set (FAS) was defined as all subjects who were randomized and received at least one dose of investigational product and had at least one post-baseline primary efficacy assessment. This was the primary analysis set for efficacy analyses.|||units on a scale||Standard Deviation|Mean
2562954|NCT02631057|Primary|Length of Stay (LoS) From Treatment of Oral Anticoagulant Initiation to Hospital Discharge Without Consideration of Baseline|The outcome measure presents LoS from initiation of treatment with oral anticoagulants to hospital discharge without consideration of baseline of patients hospitalized for any reason, who were subsequently treated with Dabigatran or Warfarin for a NVAF.|From the date of index treatment until the date of discharge from hospital, assessed upto 60 months.|The analysis set included patients who received the treatment Dabigatran Etexilate [Prazaxa®] or Warfarin.|||Months||Standard Deviation|Mean
2562955|NCT02630992|Secondary|Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 2|"Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~Plasma concentration of clavulanate 1.425 mg/kg/dose was measured.~Data points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child."|From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.|The participants are the children receiving formulation 2 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration.|||nanograms per milliliter (ng/ml)||Standard Deviation|Mean
2562956|NCT02630992|Secondary|Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 1|"Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.~Plasma concentration of clavulanate 1.6 mg/kg/dose was measured.~Data points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child."|From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.|The participants are the children receiving formulation 1 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration.|||nanograms per milliliter (ng/ml)||Standard Deviation|Mean
2562957|NCT02630992|Secondary|Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 2|"Participants treated with formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~Plasma concentration of amoxicillin 40 mg/kg/dose was measured.~Data points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child."|From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.|The participants are the children receiving formulation 2 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration.|||micrograms per milliliter (mcg/ml)||Standard Deviation|Mean
2562958|NCT02630992|Secondary|Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 1|"Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.~Plasma concentration of amoxicillin 45 mg/kg/dose was measured.~Data points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child."|From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.|The participants are the children receiving formulation 1 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration.|||micrograms per milliliter (mcg/ml)||Standard Deviation|Mean
2562959|NCT02630992|Secondary|The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 2|"Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~The parent or guardian will answer a questionnaire regarding their satisfaction with the therapy their child received. The responses 'very dissatisfied', 'somewhat dissatisfied', 'neither satisfied nor dissatisfied', 'somewhat satisfied' and 'very satisfied' correspond to scores of 1, 2, 3, 4, and 5, respectively."|The end-of-treatment visit. The mean day for this visit was 13.9.|The number of participants is equal to the number of children receiving formulation 2 whose parent or guardian completed a level of satisfaction questionnaire at the end-of-treatment visit.|||units on a scale||Standard Deviation|Mean
2562960|NCT02630992|Secondary|The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 1|"Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.~The parent or guardian will answer a questionnaire regarding their satisfaction with the therapy their child received. The responses 'very dissatisfied', 'somewhat dissatisfied', 'neither satisfied nor dissatisfied', 'somewhat satisfied' and 'very satisfied' correspond to scores of 1, 2, 3, 4, and 5, respectively."|The end-of-treatment visit. The mean day for this visit was 14.9.|The number of participants is equal to the number of children receiving formulation 1 whose parent or guardian completed a level of satisfaction questionnaire at the end-of-treatment visit.|||units on a scale||Standard Deviation|Mean
2562961|NCT02630992|Secondary|The Distribution of Participants Receiving Formulation 2 Demonstrating Resolution of Acute Otitis Media (AOM) and Substantial Improvement of Symptoms That Would Allow Discontinuing Therapy at the Day 7 Visit|"Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~An assessment of participants was conducted at the day 7 visit using the AOM-SOS scale.~The AOM-SOS scale measures five discrete items: tugging of ears, crying, irritability, difficulty sleeping, and fever. Parents are asked to rate these symptoms in comparison with the child's usual state, as none, a little, or a lot, with corresponding scores of 0, 1, and 2. Thus, total scores range from 0 to 10, with higher scores indicating greater severity of symptoms."|Day 1 of administration of amoxicillin-clavulanate until the day 7 visit. The mean day for this visit was 7.6.|The number of participants is equal to the number of children receiving formulation 2 who had a day 7 assessment.|||Participants|||Count of Participants
2563023|NCT02630472|Secondary|Change in Lund-Kennedy Endoscope Score|Pre and post treatment nasal endoscopy scored with a validated staging system for edema, -scored by an independent blind observer.|Baseline, Week 2, and Week 10|This study was terminated. Partial data was collected and is misleading due to mis-dosing. This outcome was not measured.||||||
2562962|NCT02630992|Secondary|The Distribution of Participants Receiving Formulation 1 Demonstrating Resolution of Acute Otitis Media (AOM) and Substantial Improvement of Symptoms That Would Allow Discontinuing Therapy at the Day 7 Visit|"Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.~An assessment of participants was conducted at the day 7 visit using the AOM-SOS scale.~The AOM-SOS scale measures five discrete items: tugging of ears, crying, irritability, difficulty sleeping, and fever. Parents are asked to rate these symptoms in comparison with the child's usual state, as none, a little, or a lot, with corresponding scores of 0, 1, and 2. Thus, total scores range from 0 to 10, with higher scores indicating greater severity of symptoms."|Day 1 of administration of amoxicillin-clavulanate until the day 7 visit. The mean day for this visit was 7.5.|The number of participants is equal to the number of children receiving formulation 1 who had a day 7 assessment.|||Participants|||Count of Participants
2562963|NCT02630992|Secondary|The Distribution of Participants Receiving Formulation 2 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit|"Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~Treatment failure is defined as substantial persistence or worsening of symptoms specifically attributable to AOM or of otoscopic signs of acute inflammation (bulging of the TM or intense erythema) after 72 hours from the initial AOM, such that additional antimicrobial therapy is deemed advisable. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the TM or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable."|From 72 hours after the initial AOM until the end-of-treatment visit. The mean day for this visit was 13.9.|The number of participants is equal to the number of children receiving formulation 2 who had an end-of-treatment assessment at or before the day 12 visit.|||Participants|||Count of Participants
2562964|NCT02630992|Secondary|The Distribution of Participants Receiving Formulation 1 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit|"Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.~Treatment failure is defined as substantial persistence or worsening of symptoms specifically attributable to AOM or of otoscopic signs of acute inflammation (bulging of the TM or intense erythema) after 72 hours from the initial AOM, such that additional antimicrobial therapy is deemed advisable. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the TM or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable."|From 72 hours after the initial AOM until the end-of-treatment visit. The mean day for this visit was 14.9.|The number of participants is equal to the number of children receiving formulation 1 who had an end-of-treatment assessment at or before the day 12 visit.|||Participants|||Count of Participants
2562965|NCT02630992|Primary|The Distribution of Participants Receiving Formulation 2 for Whom Diaper Dermatitis Was Reported and Associated With Study Product|"Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~Diaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent and is limited to events associated with study product.."|Day 1 of administration of amoxicillin-clavulanate until day 12.|The number of participants is equal to the number of children receiving formulation 2.|||Participants|||Count of Participants
2562966|NCT02630992|Primary|The Distribution of Participants Receiving Formulation 1 for Whom Diaper Dermatitis Was Reported and Associated With Study Product|"Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.~Diaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent and is limited to events associated with study product."|Day 1 of administration of amoxicillin-clavulanate until day 12.|The number of participants is equal to the number of children receiving formulation 1.|||Participants|||Count of Participants
2562967|NCT02630992|Primary|The Distribution of Participants Receiving Formulation 2 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product|"Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~Protocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product."|Day 1 of administration of amoxicillin-clavulanate until day 12.|The number of participants is equal to the number of children receiving formulation 2.|||Participants|||Count of Participants
2562968|NCT02630992|Primary|The Distribution of Participants Receiving Formulation 1 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product|"Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.~Protocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product."|Day 1 of administration of amoxicillin-clavulanate until day 12.|The number of participants is equal to the number of children receiving formulation 1.|||Participants|||Count of Participants
2562980|NCT02630706|Secondary|Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)|No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.|Week 12: Pre-Dose|The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo.|||ng/mL||Standard Deviation|Mean
2562969|NCT02630966|Secondary|Duration of Perianal Fistulae Response (of Those Fistulae Draining at Baseline)|Duration of fistula response was measured by number of days with/without drainage. Duration of perianal fistula response (days) was derived as the sum of days with perianal fistula response between Day 1 and the end of the study (Week 30 or early discontinuation). Perianal fistula response is defined as reduction in the number of draining perianal fistulae (of those draining at Baseline) draining of at least 50%.|Up to Week 30|The mFAS included all participants in the FAS who had at least one draining fistula at baseline (Day 1). The FAS included all randomized participants who received at least 1 dose of study medication and have a post baseline assessment of fistula healing.|||days||Full Range|Median
2562970|NCT02630966|Secondary|Time to Last (100%) Perianal Fistulae Closure (of Those Fistulae Draining at Baseline)|Closed fistulae are no longer draining despite gentle finger compression. The time to first fistula closure was analyzed descriptively using Kaplan-Meier product limit methods, with participants for which no fistula closure is reported being censored at the time of their last fistulae assessment or date of last record (Week 30 or early discontinuation). Estimated median time to fistula closure (and 95%CI) are reported.|Up to Week 30|mFAS included participants in FAS with >=1 draining fistula at baseline (Day 1). FAS included all randomized participants who received >=1 dose of study drug, have a post baseline assessment of fistula healing.|||days||95% Confidence Interval|Median
2562971|NCT02630966|Secondary|Time to First Perianal Fistulae Closure (of Those Fistulae Draining at Baseline)|Closed fistulae are no longer draining despite gentle finger compression.The time to first fistula closure was analyzed descriptively using Kaplan-Meier product limit methods, with participants for which no fistula closure is reported being censored at the time of their last fistulae assessment or date of last record (Week 30 or early discontinuation). Estimated median time to fistula closure (and 95%CI) are reported.|Up to Week 30|mFAS included participants in FAS with >=1 draining fistula at baseline (Day 1). FAS included all randomized participants who received >=1 dose of study drug, have a post baseline assessment of fistula healing.|||days||95% Confidence Interval|Median
2562972|NCT02630966|Secondary|Percentage of Participants With 100% Perianal Fistulae Closure (of the Fistulae Draining at Baseline)|Closed fistulae are no longer draining despite gentle finger compression.|Week 30|The mFAS included all participants in the FAS who had at least one draining fistula at baseline (Day 1). The FAS included all randomized participants who received at least 1 dose of study medication and have a post baseline assessment of fistula healing. Data is reported for participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2562973|NCT02630966|Secondary|Percentage of Participants With at Least 50% Reduction of From Baseline in the Number of Draining Perianal Fistulae (of Those Draining at Baseline) at Both Weeks 22 and 30|Closed fistulae are no longer draining despite gentle finger compression.|Weeks 22 and 30|The mFAS includes all participants in the FAS who had at least one draining fistula at baseline (Day 1). The FAS includes all randomized participants who received at least 1 dose of study medication and have a post baseline assessment of fistula healing. Data is reported for participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2562974|NCT02630966|Primary|Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Draining Perianal Fistulae (of Those Draining at Baseline)|Closed fistulae are no longer draining despite gentle finger compression.|Baseline, Week 30|Modified Full Analysis Set (mFAS) included all participants in FAS who had at least one draining fistula at baseline (Day 1). FAS included all randomized participants who received at least 1 dose of study medication and have a post baseline assessment of fistula healing. Data is reported for participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2562975|NCT02630719|Primary|Timolol Eye Drops in the Treatment of Acute Migraine Headache|"Percent of migraine attacks at 0 or 1 on the 4-point Rating Scale recommended by the International Headache Society:~0: no headache~mild headache~moderate headaches~severe headache"|4 months||||percentage of migraine attacks at 0 or 1||Standard Deviation|Mean
2562976|NCT02630706|Secondary|Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)|No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.|Week 26: Pre-Dose|The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo.|||ng/mL||Standard Deviation|Mean
2562977|NCT02630706|Secondary|Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)|No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.|Week 18: 60 min. Post-Dose|The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo.|||ng/mL||Standard Deviation|Mean
2562978|NCT02630706|Secondary|Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)|No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.|Week 18: Pre-Dose|The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo.|||ng/mL||Standard Deviation|Mean
2562979|NCT02630706|Secondary|Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)|No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.|Week 12: 60 min. Post-Dose|The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo.|||ng/mL||Standard Deviation|Mean
2566423|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Total Cholesterol||Baseline, Week 24|Participants with measurements at given time point.|||mmol/L||Standard Deviation|Mean
2562981|NCT02630706|Secondary|Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach (China Subpopulation)|No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.|Week 6: Pre-Dose|The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo.|||ng/mL||Standard Deviation|Mean
2562982|NCT02630706|Secondary|Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach|No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.|Week 26: Pre-Dose|The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo.|||ng/mL||Standard Deviation|Mean
2562983|NCT02630706|Secondary|Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach|No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.|Week 18: 60 min. Post-Dose|The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo.|||ng/mL||Standard Deviation|Mean
2562984|NCT02630706|Secondary|Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach|No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.|Week 18: Pre-Dose|The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo.|||ng/mL||Standard Deviation|Mean
2562985|NCT02630706|Secondary|Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach|No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.|Week 12: 60 min. Post-Dose|The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo.|||ng/mL||Standard Deviation|Mean
2562986|NCT02630706|Secondary|Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach|No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.|Week 12: Pre-Dose|The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo.|||ng/mL||Standard Deviation|Mean
2562987|NCT02630706|Secondary|Ertugliflozin Plasma Concentrations Summary Statistics Over Time: Including Rescue Approach|No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL.|Week 6: Pre-Dose|The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one plasma concentration value above the lower limit of quantification. No ertugliflozin plasma concentrations were determined for participants receiving placebo.|||ng/mL||Standard Deviation|Mean
2562988|NCT02630706|Secondary|Time to Glycemic Rescue Therapy (China Subpopulation)|Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.|Up to 149 days|The analysis population included all randomized participants in China who received at least one dose of investigational product and who received glycemic rescue through Week 26. No participants in the Ertugliflozin 5 mg group were rescued.|||Days||Full Range|Median
2562989|NCT02630706|Secondary|Time to Glycemic Rescue Therapy|Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.|Up to 183 days|The analysis population included all randomized participants who received at least one dose of investigational product who received glycemic rescue through Week 26.|||Days||Full Range|Median
2562990|NCT02630706|Secondary|Percentage of Participants Requiring Glycemic Rescue Therapy Through Week 26 (China Subpopulation)|Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.|Week 26|The analysis population included all randomized participants in China who received at least one dose of investigational product.|||Percentage of Participants|||Number
2562991|NCT02630706|Secondary|Percentage of Participants Requiring Glycemic Rescue Therapy Through Week 26.|Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment.|Week 26|The analysis population included all randomized participants who received at least one dose of investigational product.|||Percentage of Participants|||Number
2562992|NCT02630706|Secondary|Percentage of Participants With HbA1c of <6.5% (48 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach) (China Subpopulation)|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Week 26|The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26.|||Percentage of participants|||Number
2563020|NCT02630472|Other Pre-specified|Rescue Antibiotics|The necessity for rescue oral antibiotics for persistent infection.|Week 2 and Week 10|This study was terminated. Partial data was collected and is misleading due to mis-dosing. This outcome was not measured.||||||
2562993|NCT02630706|Secondary|Percentage of Participants With HbA1c of <6.5% (48 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach)|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Week 26|The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26.|||Percentage of participants|||Number
2562994|NCT02630706|Secondary|Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 (Excluding Rescue Approach) (China Subpopulation)|This change from baseline reflects the Week 26 sitting diastolic blood pressure (DBP) minus the Week 0 sitting DBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26.|||mmHg||95% Confidence Interval|Least Squares Mean
2562995|NCT02630706|Secondary|Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 (Excluding Rescue Approach)|This change from baseline reflects the Week 26 sitting diastolic blood pressure (DBP) minus the Week 0 sitting DBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26.|||mmHg||95% Confidence Interval|Least Squares Mean
2562996|NCT02630706|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 26 (Excluding Rescue Approach) (China Subpopulation)|This change from baseline reflects the Week 26 sitting systolic blood pressure (SBP) minus the Week 0 sitting SBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26.|||mmHg||95% Confidence Interval|Least Squares Mean
2562997|NCT02630706|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 26 (Excluding Rescue Approach)|This change from baseline reflects the Week 26 sitting systolic blood pressure (SBP) minus the Week 0 sitting SBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26.|||mmHg||95% Confidence Interval|Least Squares Mean
2562998|NCT02630706|Secondary|Percentage of Participants With HbA1c of <7.0% (53 mmol/Mol) (Logistic Regression Using Multiple Imputation Based on cLDA Model: Excluding Rescue Approach) (China Subpopulation)|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Week 26|The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26.|||Percentage of participants|||Number
2562999|NCT02630706|Secondary|Percentage of Participants With HbA1c of <7.0% (53 mmol/Mol) (Logistic Regression Using Multiple Imputation Based on cLDA Model: Excluding Rescue Approach)|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Week 26|The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26.|||Percentage of participants|||Number
2563021|NCT02630472|Secondary|Change in Sniffin' Stick-12 Score|"Change in olfactory sense from baseline to week 10 will be measured using the Sniffin' Stick-12 system. Patients will smell each sniffing pen and record the smell they detect. A score between 0-12 will indicate olfactory sense."|Baseline, Week 2 and Week 10|This study was terminated. Partial data was collected and is misleading due to mis-dosing. This outcome was not measured.||||||
2563022|NCT02630472|Secondary|Change in the 22-item Sinonasal Outcomes Test Score|Pre and post treatment quality of life questionnaires (22-item Sinonasal Outcomes Test [SNOT-22]).|Baseline, Week 2, and Week 10|This study was terminated. Partial data was collected and is misleading due to mis-dosing. This outcome was not measured.||||||
2563000|NCT02630706|Secondary|Change From Baseline in Body Weight at Week 26 (Excluding Rescue Approach) (China Subpopulation)|The change in body weight from baseline reflects the Week 26 body weight minus the Week 0 body weight (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26.|||Kilograms||95% Confidence Interval|Least Squares Mean
2563001|NCT02630706|Secondary|Change From Baseline in Body Weight at Week 26 (Excluding Rescue Approach)|The change in body weight from baseline reflects the Week 26 body weight minus the Week 0 body weight (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants and who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26.|||Kilograms||95% Confidence Interval|Least Squares Mean
2563002|NCT02630706|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 26 (Excluding Rescue Approach) (China Subpopulation)|Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at Week 0) which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26.|||mg/dL||95% Confidence Interval|Least Squares Mean
2563003|NCT02630706|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 26 (Excluding Rescue Approach)|Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at Week 0) which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26.|||mg/dL||95% Confidence Interval|Least Squares Mean
2563004|NCT02630706|Primary|Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach) (China Subpopulation)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 26 weeks|The analysis population included all randomized participants in China who received at least one dose of investigational product.|||Percentage of Participants|||Number
2563005|NCT02630706|Primary|Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 26 weeks|The analysis population included all randomized participants who received at least one dose of investigational product.|||Percentage of Participants|||Number
2563006|NCT02630706|Primary|Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach) (China Subpopulation)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 28 weeks|The analysis population included all randomized participants in China who received at least one dose of investigational product .|||Percentage of participants|||Number
2563007|NCT02630706|Primary|Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 28 weeks|The analysis population included all randomized participants who received at least one dose of investigational product.|||Percentage of participants|||Number
2563008|NCT02630706|Primary|Change From Baseline in A1C (%) at Week 26 (Excluding Rescue Approach) (China Subpopulation)|A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants in China who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26.|||Percentage A1C||95% Confidence Interval|Least Squares Mean
2563009|NCT02630706|Primary|Change From Baseline in A1C (%) at Week 26 (Excluding Rescue Approach)|A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants who received at least one dose of investigational product and who had at least one assessment of the respective endpoint at baseline or post baseline up to Week 26.|||Percentage A1C||95% Confidence Interval|Least Squares Mean
2563010|NCT02630693|Secondary|Overall Survival|Time from randomization to death of any cause.|2 years|Intend to treat population|||months||90% Confidence Interval|Median
2563011|NCT02630693|Secondary|Duration of Response|For patients with complete or partial response, duration of response is defined as days from first recorded response to the first date of recurrent or progression or death.|2 years||||days||Inter-Quartile Range|Median
2563012|NCT02630693|Secondary|Number of Participants With Response or No Response|Response rate = Number of (Complete response + partial response) / total treated patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|2 years|Only patients received protocol treatment were included in this analysis|||Participants|||Count of Participants
2563013|NCT02630693|Primary|Progression Free Survival Using the RECIST 1.1 Criteria|progression free survival (PFS) is defined as time from randomization to progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 years|Intend to treat population|||months||95% Confidence Interval|Median
2563014|NCT02630563|Secondary|Plasma Concentration of Mycophenolic Acid and Its Metabolite Mycophenolic Acid Glucuronide at Each Time Point|Mycophenolic Acid Glucuronide (MPAG) is an active metabolite of Mycophenolic Acid (MPA).|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants greater than (>) 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants less than (<) 24 months|The PK population included all randomized and replaced participants adherent to the PK section of the protocol.|||mcg/mL||Standard Deviation|Mean
2563015|NCT02630563|Primary|Area Under the Plasma Concentration-Time Curve From 0 to 12 Hours of Mycophenolic Acid Normalized for Dose And for Body Surface Area|The area under the plasma concentration-time curve from time zero to twelve hours (AUC [0-12h]) is area under the plasma concentration-time curve from time zero through 12 hours. AUC (0-12) hours was computed using the linear trapezoidal rule. For the calculations of AUC (0-12h), concentrations below the limit of quantification were assigned a value of zero if they occurred at the beginning of a profile. When such values appeared at the end of a profile they were assigned as missing data. AUC0-12h was normalized to 600 milligram per square meter (mg/m^2) and 1.5 gram. AUC was reported in microgram hour per milliliter (mcg*h/mL).|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants greater than (>) 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants less than (<) 24 months|The pharmacokinetic (PK) population included all randomized and replaced participants adherent to the PK section of the protocol.|||mcg*h/mL||Standard Deviation|Mean
2563016|NCT02630563|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.|Up to Day 32|The safety population included all participants who were enrolled in the trial|||participants|||Number
2563017|NCT02630563|Secondary|Time to Maximum Plasma Concentration for Mycophenolic Acid and Mycophenolic Acid Glucuronide|Tmax is the amount of time after dosing to when the maximum concentration of MPA and MPAG was achieved.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants > 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants < 24 months|The PK population was used for the analysis.|||hour||Full Range|Median
2563018|NCT02630563|Secondary|Maximum Plasma Concentration for Mycophenolic Acid and Mycophenolic Acid Glucuronide|The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was obtained directly from the measured plasma concentration-time curves.|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants > 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants < 24 months|The PK population was used for the analysis.|||mcg/mL||Standard Deviation|Mean
2563019|NCT02630563|Secondary|Area Under the Plasma Concentration Time Curve From 0-12 Hours for Mycophenolic Acid and Mycophenolic Acid Glucuronide Phenolic Glucuronide of Mycophenolic Acid|The area under the plasma concentration-time curve from time zero to twelve hours (AUC [0-12h]) is area under the plasma concentration-time curve from time zero through 12 hours. AUC (0-12) hours was computed using the linear trapezoidal rule. For the calculations of AUC (0-12h), concentrations below the limit of quantification were assigned a value of zero if they occurred at the beginning of a profile. When such values appeared at the end of a profile they were assigned as missing data. AUC was reported in microgram hour per milliliter (mcg*h/mL).|Pre-dose, 0.5, 0.75, 1.0, 1.5, 2.0, 4.0, 8.0, and 12.0 hours post oral dosing for participants greater than (>) 24 months, and at pre-dose, 0.75, 2.0, 4.0 and 12.0 hours post oral dosing for participants less than (<) 24 months|The PK population included all randomized and replaced participants adherent to the PK section of the protocol|||mcg*h/mL||Standard Deviation|Mean
2566424|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Serum Creatinine||Baseline, Week 48|Participants with measurements at given time point.|||µmol/L||Standard Deviation|Mean
2563025|NCT02630459|Secondary|Change From Baseline in Mean Monthly Acute Migraine-Specific Medication Treatment Days at Months 4, 5 and 6|"An acute migraine-specific medication treatment day was defined as any calendar day during which the participant took a migraine-specific medication (ie, triptan or ergotamine-derivatives).~The change from baseline was calculated using the mean monthly acute migraine-specific medication treatment days over the last three months (months 4, 5 and 6) of the double-blind treatment phase minus the baseline monthly acute migraine-specific medication treatment days.~LS mean was estimated using a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (prior/current treatment), and baseline value as covariates."|4-week baseline phase and months 4, 5 and 6 of double-blind treatment phase.|Participants who received at least 1 dose of the investigational product and had at least 1 change from baseline measurement in acute migraine-specific medication treatment days during the double-blind treatment phase (Efficacy Analysis Set).|||Days||95% Confidence Interval|Least Squares Mean
2563026|NCT02630459|Secondary|Percentage of Participants With at Least a 50% Reduction From Baseline in Mean Monthly Migraine Days at Months 4, 5 and 6|"A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation or recurrence of the migraine headache). A qualified migraine headache was a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: a) ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe, exacerbated with exercise/physical activity; b) ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia.~At least a 50% reduction from baseline in monthly migraine days was determined if; (mean monthly migraine days over the last three months of the double-blind treatment phase minus baseline monthly migraine days) * 100 / baseline monthly migraine days, was less than or equal to -50%."|4-week baseline phase and months 4, 5 and 6 of double-blind treatment phase.|Participants who received at least 1 dose of the investigational product and had at least 1 change from baseline measurement in monthly migraine days during the double-blind treatment phase (Efficacy Analysis Set).|||Percentage of participants|||Number
2563027|NCT02630459|Primary|Change From Baseline in Mean Monthly Migraine Days at Months 4, 5 and 6|A migraine day was defined as any calendar day in which the participant experienced a qualified migraine headache (onset, continuation or recurrence of the migraine headache). A qualified migraine headache was a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: a) ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe, exacerbated with exercise/physical activity; b) ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia. Change from baseline was calculated using the mean monthly migraine days from months 4, 5 and 6 of the double-blind treatment phase minus the number of migraine days during the 4-week baseline phase. Least squares (LS) mean was estimated using a generalized linear mixed model which included treatment, visit, treatment by visit interaction, stratification factor (current, prior only, or no prior/current treatment), and baseline value as covariates.|4-week baseline phase and months 4, 5 and 6 of double-blind treatment phase.|Participants who received at least 1 dose of the investigational product and had at least 1 change from baseline measurement in monthly migraine days during the double-blind treatment phase (Efficacy Analysis Set).|||Days||95% Confidence Interval|Least Squares Mean
2563028|NCT02630251|Secondary|Volume of Distribution (Vz/F) of GSK2820151|Blood samples were collected at indicated timepoints for analysis of Vz/F. The average SD for each participant was calculated over indicated time points Week 1, Day 1and Week 3, Day 4. PK parameters were conducted by non-compartmental methods using Phoenix WinNonlin.|Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)|PK Population|||Liters||Standard Deviation|Mean
2563029|NCT02630251|Secondary|Clearance (CL/F) of GSK2820151|Blood samples were collected at indicated timepoints for analysis of CL/F. The average SD for each participant was calculated over indicated time points Week 1, Day 1and Week 3, Day 4. PK parameters were conducted by non-compartmental methods using Phoenix WinNonlin.|Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)|PK Population|||Liters per hour||Standard Deviation|Mean
2563030|NCT02630251|Secondary|Time Invariance of GSK2820151|Blood samples were collected at indicated timepoints for analysis of time invariance. Time invariance was calculated as the ratio of AUC(0-tau) on Week 3 Day 4 divided by AUC(0-inf) on Week 1 Day 1. The ratio for SD was calculated from AUC(0-tau) on Week 3 Day 4 and AUC(0-inf) on Week 1 Day 1 parameters for each participant.|Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)|PK Population.|||Ratio||Standard Deviation|Mean
2563031|NCT02630251|Secondary|Accumulation Ratio (Ro) of GSK2820151|Blood samples were collected at indicated timepoints for analysis of Ro. Ro was calculated as the ratio of AUC(0-tau) on Week 3 Day 4 divided by AUC(0-tau) on Week 1 Day 1. The ratio was calculated from AUC(0-tau) on Week 3 Day 4 and AUC(0-tau) on Week 1 Day 1 parameters for each participant.|Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)|PK Population|||Ratio||Standard Deviation|Mean
2563032|NCT02630251|Secondary|Trough Concentration (Ctau) of GSK2820151|Blood samples were collected at indicated timepoints for analysis of Ctau. The average SD for each participant was calculated over indicated time points Week 1, Day 1and Week 3, Day 4. PK parameters were conducted by non-compartmental methods using Phoenix WinNonlin.|Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)|PK Population|||Nanograms per milliliter||Standard Deviation|Mean
2563033|NCT02630251|Secondary|Apparent Terminal Phase Half-life (t1/2) of GSK2820151|Blood samples were collected at indicated time-points for analysis of t1/2. The average SD for each participant was calculated over indicated time points Week 1, Day 1and Week 3, Day 4. PK parameters were conducted by non-compartmental methods using Phoenix WinNonlin.|Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)|PK Population|||Hours||Standard Deviation|Mean
2563116|NCT02629354|Primary|Cmax of R-ibuprofen|This outcome measure presents the Cmax of R-ibuprofen in plasma obtained directly from the concentration-time data.|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563034|NCT02630251|Secondary|Area Under the Plasma Concentration-time Curve From Zero to Tau (AUC[0-tau]) of GSK2820151|Blood samples were collected at indicated time-points for analysis of AUC(0-tau). The average SD for each participant was calculated over indicated time points Week 1, Day 1and Week 3, Day 4. PK parameters were conducted by non-compartmental methods using Phoenix WinNonlin.|Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)|PK Population|||Hours* nanogram per milliliter||Standard Deviation|Mean
2563035|NCT02630251|Secondary|Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC[0-inf])|Blood samples were collected at indicated timepoints for analysis of AUC(0-inf). The average SD for each participant was calculated over indicated time points Week 1, Day 1and Week 3, Day 4. PK parameters was conducted by non-compartmental methods using Phoenix WinNonlin.|Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)|PK Population|||Hours* nanogram per milliliter||Standard Deviation|Mean
2563036|NCT02630251|Secondary|Area Under the Plasma Concentration-time Curve From Zero to Time (AUC[0-t]) of GSK2820151|Blood samples were collected at indicated time-points for analysis of AUC(0-t). The average SD for each participant was calculated over indicated time points Week 1, Day 1and Week 3, Day 4. PK parameters were conducted by non-compartmental methods using Phoenix WinNonlin|Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)|PK Population|||Hours* nanogram per milliliter||Standard Deviation|Mean
2563037|NCT02630251|Secondary|Time to Cmax (Tmax) of GSK2820151|Blood samples were collected at indicated timepoints for analysis of Tmax. PK parameters were conducted by non-compartmental methods using Phoenix WinNonlin.|Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)|PK Population|||Hours||Full Range|Median
2563038|NCT02630251|Secondary|Maximum Observed Concentration (Cmax) of GSK2820151|Blood samples were collected at indicated timepoints for analysis of Cmax. The average Standard Deviation (SD) for each participant was calculated over indicated time points Week 1, Day 1and Week 3, Day 4. Pharmacokinetic (PK) parameters were conducted by non-compartmental methods using Phoenix WinNonlin. PK Population consisted of all subjects from the All Treated Population for whom a PK sample is obtained and analyzed|Week 1, Day 1 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 33 hours post-dose); Week 3, Day 4 (Pre-dose, 15 and 30 minutes, 1, 2, 4, 8, 16, 24 and 48 hours)|PK Population|||Nanograms per milliliter||Standard Deviation|Mean
2563039|NCT02630251|Secondary|Messenger Ribonucleic Acid (mRNA) Analysis for PD Data|Blood samples were planned to be collected for analysis of mRNA.|2 years 8 months|PK Population. Data was not collected for this endpoint as the study was terminated.||||||
2563040|NCT02630251|Secondary|Protein Biomarker (Cytokines and Acute Phase Proteins) Analysis for Pharmacodynamic (PD) Data|Blood samples were planned to be collected for analysis of protein PD biomarkers like cytokines and acute phase proteins.|2 years 8 months|PK Population. Data was not collected for this endpoint as the study was terminated.||||||
2563041|NCT02630251|Secondary|Progression Free Survival (PFS)|PFS is defined as the interval of time (in weeks) between the start date of treatment and the earlier of the date of disease progression and the date of death due to any cause. PFS was censored at the last adequate assessment where visit level response is CR, PR, or stable disease.|2 years 8 months|All Treated Population|||Weeks|||Number
2563042|NCT02630251|Secondary|Overall Response Rate (ORR)|The ORR is defined as the percentage of participants with a confirmed complete response (CR) or a partial response (PR) at any time as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.|2 years 8 months|All Treated Population|||Percentage of participants|||Number
2563043|NCT02630251|Secondary|Changes in Cardiac Safety Including Heart Rate|Change in heart rate was assessed. Baseline is defined as the most recent, non-missing value prior to or on the first study treatment dose date for GSK2820151. Change from baseline was calculated as visit value minus Baseline value.|Baseline and up to 2 years 8 months|All Treated Population|||Beats per minute||Standard Deviation|Mean
2563044|NCT02630251|Secondary|Changes in Cardiac Safety Including Corrected QT Interval (QTc)|Changes in cardiac parameters like QTc, PR Interval, QRS duration, and QT interval were assessed. Baseline is defined as the most recent, non-missing value prior to or on the first study treatment dose date for GSK2820151. Change from baseline was calculated as visit value minus Baseline value.|Baseline and up to 2 years 8 months|All Treated Population|||Milliseconds||Standard Deviation|Mean
2563045|NCT02630251|Secondary|Number of Participants With Dose-limiting Toxicities (DLT)|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. DLTs included Grade 4 neutropenia, Febrile neutropenia, Grade 4 anemia, Grade 3 thrombocytopenia, Alanine aminotransferase (ALT) >3 times upper limit of normal (ULN) plus bilirubin >=2 times ULN (>35 percent direct) or ALT between 3-5 times ULN with bilirubin < 2 times ULN but with hepatitis symptoms or rash, Grade 3 nausea, vomiting or diarrhea, Grade 3 hypertension, Grade 4 hypertension, Grade 3 or greater clinically significant non-hematologic toxicity, Grade 2 troponin B elevation were considered as DLT.|Up to 4 weeks|All Treated Population|||Participants|||Count of Participants
2563046|NCT02630251|Primary|Number of Participants With Clinically Significant Abnormalities for Electrocardiogram (ECG)|Triple 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT and corrected QT using Fridericia's formula (QTcF) intervals.|2 years 8 months|All Treated Population|||Participants|||Count of Participants
2563047|NCT02630251|Primary|Number of Participants With Clinically Significant Abnormalities for Vital Signs Parameters|Vital signs included systolic blood pressure and diastolic blood pressure, heart rate, and temperature.|2 years 8 months|All Treated Population|||Participants|||Count of Participants
2563048|NCT02630251|Primary|Number of Participants With Clinically Significant Abnormalities for Gastrointestinal Parameters|Blood samples were collected at indicated time-points for the analysis of gastrointestinal parameters like cytokines and C-peptide.|2 years 8 months|All Treated Population|||Participants|||Count of Participants
2563705|NCT02621060|Primary|Glycated Hemoglobin A1c (A1C)|Shows what a person's average blood glucose level was for the 2 to 3 months before the test high-performance.|Week 12.|3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.|||Percentage of A1C||Standard Deviation|Mean
2563049|NCT02630251|Primary|Number of Participants With Clinically Significant Abnormalities for Urinalysis Parameters|Urine samples were collected at indicated time-points for the analysis of urinalysis parameters like potential of hydrogen (pH), microscopic examination, specific gravity, ketones, protein, glucose, and blood.|2 years 8 months|All Treated Population|||Participants|||Count of Participants
2563050|NCT02630251|Primary|Number of Participants With Clinically Significant Abnormalities for Hematology Parameters|Blood samples were collected at indicated time-points for the analysis of hematology parameters like hemoglobin (HGB), platelet count, red blood cell (RBC) count, white blood cell (WBC) count, neutrophils, lymphocytes, monocytes, eosinophils, and basophils.|2 years 8 months|All Treated Population|||Participants|||Count of Participants
2563051|NCT02630251|Primary|Number of Participants With Clinically Significant Abnormalities for Clinical Chemistry Parameters|Blood samples were collected at indicated time-points for the analysis of clinical chemistry parameters like total and direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total protein, albumin, sodium, potassium, calcium, blood urea nitrogen (BUN), creatinine, chloride, fasting glucose, ionized calcium, gamma-glutamyltransferase, total carbon dioxide , uric acid, and magnesium.|2 years 8 months|All Treated Population|||Participants|||Count of Participants
2563052|NCT02630251|Primary|Number of Participants Withdrawn Due to Toxicities|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Withdrawals due to toxicities were evaluated.|2 years 8 months|All Treated Population|||Participants|||Count of Participants
2563053|NCT02630251|Primary|Number of Participants With Dose Delays and Reduction|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.|2 years 8 months|All Treated Population|||Participants|||Count of Participants
2563054|NCT02630251|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE.|2 years 8 months|All Treated Population included all participants who received at least one dose of GSK2820151.|||Participants|||Count of Participants
2563055|NCT02630186|Secondary|Longitudinal Changes in Blood Based Biomarkers (eg, Mutations in EGFR) in ctDNA|Tumor tissue, plasma, and blood specimens will be used for pharmacodynamic assessment of rociletinib and/or MPDL3280A activity, to evaluate the concordance of mutant EGFR detection between tissue and plasma, and to explore biomarkers that may be predictive of response or resistance to rociletinib and/or MPDL3280A. Biomarkers and changes in biomarker status will be investigated for associations with rociletinib and/or MPDL3280A exposure, safety, and clinical activity. Given the limited sample size, no formal statistical analysis is planned.|Blood samples will be collected from each patient approximately every 3 weeks, up to 24 months|Due to the small number of patients enrolled and small number of samples collected as a result of early termination of the study, these analyses were not conducted.||||||
2563056|NCT02630186|Secondary|Number of Patients Alive at Study Termination|Patients who received the combination of rociletinib and MPDL3280A alive at the termination of this study.|Up to approximately 18.5 months|Count of the number of enrolled patients alive at study termination.|||participants|||Number
2563057|NCT02630186|Secondary|Progression-free Survival Per RECIST v1.1 and Modified RECIST v1.1, Incorporating Immune-related Criteria, in Phase 2|"Conventional response criteria may not be adequate to characterize the antitumor activity of immunotherapeutic agents like MPDL3280A, which can produce delayed responses that may be preceded by initial apparent radiological progression, including the appearance of new lesions. Therefore, modified response criteria have been developed that account for the possible appearance of new lesions and allow radiological progression to be confirmed at a subsequent assessment. In this protocol, patients will be permitted to continue study treatment even after modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease are met if the benefit-risk ratio is judged to be favorable.~These modified criteria are derived from RECIST version 1.1 (v1.1) conventions and immune related response criteria (irRC)."|Approximately every 6-9 weeks, up to 24 months|Given the early termination of the study and that no patients were enrolled in Phase 2 of the study, no conclusions can be drawn.||||||
2563058|NCT02630186|Secondary|Duration of Response Per RECIST v1.1 and Modified RECIST v1.1, Incorporating Immune-related Criteria, in Phase 2|"Conventional response criteria may not be adequate to characterize the antitumor activity of immunotherapeutic agents like MPDL3280A, which can produce delayed responses that may be preceded by initial apparent radiological progression, including the appearance of new lesions. Therefore, modified response criteria have been developed that account for the possible appearance of new lesions and allow radiological progression to be confirmed at a subsequent assessment. In this protocol, patients will be permitted to continue study treatment even after modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease are met if the benefit-risk ratio is judged to be favorable.~These modified criteria are derived from RECIST version 1.1 (v1.1) conventions and immune related response criteria (irRC)."|Approximately every 6-9 weeks, up to 24 months|Given the early termination of the study and that no patients were enrolled in Phase 2 of the study, no conclusions can be drawn.||||||
2563070|NCT02629965|Post-Hoc|Inspiratory Capacity [Litre] Treatment Comparisons of 6-Minute Walk Test (6MWT) in−Completer at Baseline Period|At day 43 adjusted mean (standard error) of inspiratory capacity [Litre] test comparisons after 6 weeks of each test for 6MWT in−completer at baseline period. Adjusted mean was entered instead of mean in statistical analysis.|Day 43, 60 minutes post-dose after 6 weeks of each treatment|Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.|||Litre (L)||Standard Error|Mean
2563519|NCT02623803|Secondary|Pain at Rest|Pain at rest will be measured 30 minutes after arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.|30 minutes after arrival to PACU||||score on a scale||Standard Deviation|Mean
2563059|NCT02630186|Secondary|Objective Response Rate Per Modified RECIST v1.1, Incorporating Immune-related Criteria, in Phase 2|"Conventional response criteria may not be adequate to characterize the antitumor activity of immunotherapeutic agents like MPDL3280A, which can produce delayed responses that may be preceded by initial apparent radiological progression, including the appearance of new lesions. Therefore, modified response criteria have been developed that account for the possible appearance of new lesions and allow radiological progression to be confirmed at a subsequent assessment. In this protocol, patients will be permitted to continue study treatment even after modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for progressive disease are met if the benefit-risk ratio is judged to be favorable.~These modified criteria are derived from RECIST version 1.1 (v1.1) conventions and immune related response criteria (irRC)."|Approximately every 6-9 weeks, up to 24 months|Given the early termination of the study and that no patients were enrolled in Phase 2 of the study, no conclusions can be drawn.||||||
2563060|NCT02630186|Primary|Objective Response Rate Per RECIST v1.1 in Phase 2|"To determine the efficacy of the combination of rociletinib and MPDL3280A based on overall response rate per RECIST v1.1 in the following groups of patients:~Group A: Patients with EGFRm advanced or metastatic NSCLC who have not previously received an EGFR TKI or chemotherapy.~Group B: Patients with EGFRm advanced or metastatic NSCLC who have progressed on a prior EGFR TKI."|Approximately every 6-9 weeks|Given the early termination of the study and that no patients were enrolled in Phase 2 of the study, no conclusions can be drawn.||||||
2563061|NCT02630186|Primary|Minimum Concentration (Cmin) of MPDL3280A|Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmin for MPDL3280A will be assessed using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.|Approximately every 6 weeks up to 24 months|Due to the small number of patients enrolled and small number of PK samples collected as a result of early termination of the study, these analyses were not conducted.||||||
2563062|NCT02630186|Primary|Maximum Concentration (Cmax) of MPDL3280A|Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmax, for MPDL3280A will be assessed using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.|Cycle 1 Day 1|Due to the small number of patients enrolled and small number of PK samples collected as a result of early termination of the study, these analyses were not conducted.||||||
2563063|NCT02630186|Primary|Area Under the Curve (AUC) of Rociletinib and Rociletinib Metabolites|Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. AUC0 24 will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.|Treatment Day 1 and Day 8|Due to the small number of patients enrolled and small number of PK sample collected as a result of early termination of the study, these analyses were not conducted.||||||
2563064|NCT02630186|Primary|Minimum Concentration (Cmin) of Rociletinib and Metabolites|Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmin will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.|Approximately every 6 weeks up to 24 months|Due to the small number of patients enrolled and small number of PK samples collected as a result of early termination of the study, these analyses were not conducted.||||||
2563065|NCT02630186|Primary|Time to Maximum Concentration (Tmax) for Rociletinib and Rociletinib Metabolites|Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Tmax will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.|Treatment Day 1 and Day 15|Due to the small number of patients enrolled and small number of PK samples collected as a result of early termination of the study, these analyses were not conducted.||||||
2563066|NCT02630186|Primary|Maximum Concentration (Cmax) of Rociletinib and Its Metabolites|Blood sampling for PK analyses of both rociletinib and MPDL3280A will be conducted in all patients treated with rociletinib and MPDL3280A. Cmax will be estimated for rociletinib, using non-compartmental models. Comparisons across dose levels will be made to assess proportionality.|Treatment Day 1 and Day 15|Due to the small number of patients enrolled and small number of PK samples collected as a result of early termination of the study, these analyses were not conducted.||||||
2563067|NCT02630186|Primary|Number of Treatment-emergent Adverse Events, as Assessed by NCI CTCAE v4.03|The safety analyses will be performed using the safety population. Safety data analysis will be conducted on all patients receiving at least one dose of rociletinib or MPDL3280A.|Continuously, up to approximately 18.5 months|All patients enrolled in the study.|||Treatment emergent adverse events|||Number
2563068|NCT02629965|Post-Hoc|Inspiratory Capacity [Litre] Treatment Comparisons of Subgroup of Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III/IV|At day 43 adjusted mean (standard error) of inspiratory capacity [Litre] treatment comparisons after 6 weeks of each treatment for subgroup of GOLD stage III/IV. Adjusted mean was entered instead of mean in statistical analysis.|Day 43, 60 minutes post-dose after 6 weeks of each treatment|Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.|||Litre (L)||Standard Error|Mean
2563069|NCT02629965|Post-Hoc|Inspiratory Capacity [Litre] Treatment Comparisons of Subgroup of Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage I/II|At day 43 adjusted mean (standard error) of inspiratory capacity [Litre] treatment comparisons after 6 weeks of each treatment for subgroup of GOLD stage I/II. Adjusted mean was entered instead of mean in statistical analysis.|Day 43, 60 minutes post-dose after 6 weeks of each treatment|Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.|||Litre (L)||Standard Error|Mean
2563083|NCT02629965|Primary|Inspiratory Capacity at Rest Measured at 60 Minutes Post-dose|At day 43 inspiratory capacity at rest measured at 60 minutes post-dose, after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.|Day 43, 60 minutes post-dose after 6 weeks of each treatment|Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.|||Litre (L)||Standard Error|Mean
2563071|NCT02629965|Post-Hoc|Inspiratory Capacity [Litre] Test Comparisons of 6-Minute Walk Treatment (6MWT) in−Completer at Treatment Period|At day 43 adjusted mean (standard error) of inspiratory capacity [Litre] test comparisons after 6 weeks of each treatment for 6MWT in−completer at treatment period. Adjusted mean was entered instead of mean in statistical analysis.|Day 43, 60 minutes post-dose after 6 weeks of each treatment|Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.|||Litre (L)||Standard Error|Mean
2563072|NCT02629965|Post-Hoc|Inspiratory Capacity [Litre] Treatment Comparisons of 6-Minute Walk Test (6MWT) Completer at Baseline Period|At day 43 adjusted mean (standard error) of inspiratory capacity [Litre] test comparisons after 6 weeks of each treatment for 6MWT completer at baseline period. Adjusted mean was entered instead of mean in statistical analysis.|Day 43, 60 minutes post-dose after 6 weeks of each treatment|Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.|||Litre (L)||Standard Error|Mean
2563073|NCT02629965|Post-Hoc|Inspiratory Capacity [Litre] Treatment Comparisons of 6-Minute Walk Test (6MWT) Completer at Treatment Period|At day 43 adjusted mean (standard error) of inspiratory capacity [Litre] test comparisons after 6 weeks of each treatment for 6MWT completer at treatment period. Adjusted mean was entered instead of mean in statistical analysis.|Day 43, 60 minutes post-dose after 6 weeks of each treatment|Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.|||Litre (L)||Standard Error|Mean
2563074|NCT02629965|Secondary|30 Minutes Post-dose Forced Vital Capacity (FVC) (in Litre)|At day 43 adjusted mean (SE) of 30 minute post−dose forced vital capacity (FVC) [Litre] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.|Day 43, 30 minutes post-dose after 6 weeks of each treatment|Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.|||Litre (L)||Standard Error|Mean
2563075|NCT02629965|Secondary|30 Minutes Post-dose Forced Expiratory Volume in One Second (FEV1) (in Litre)|At day 43 adjusted mean (SE) of 30 minute post−dose forced expiratory volume in one second (FEV1) [Litre] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.|Day 43, 30 minutes post-dose after 6 weeks of each treatment|Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.|||Litre (L)||Standard Error|Mean
2563076|NCT02629965|Secondary|60 Minutes Post-dose Slow Vital Capacity (SVC) (in Litre)|At day 43 adjusted mean (SE) of 60 minute post−dose slow vital capacity [Litre] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.|Day 43, 60 minutes post-dose after 6 weeks of each treatment|Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.|||Litre (L)||Standard Error|Mean
2563077|NCT02629965|Secondary|Average Daily Active Strength (Metabolic Equivalents*Minutes) of ≥ 3 METs|At day 43 adjusted mean (SE) of average daily active strength [METs x minute] of >=3 METs treatment comparisons measured by the activity monitor in 2 weeks prior to Week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis.|2 weeks prior to Week 6 per treatment|Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.|||Metabolic equivalents * minutes||Standard Error|Mean
2563078|NCT02629965|Secondary|Average Daily Duration (Minutes) of ≥ 2 Metabolic Equivalents (METs)|At day 43 adjusted mean (SE) of average daily duration [minute] of ≥ 2 METs treatment comparison measured by the activity monitor in 2 weeks prior to Week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis.|2 weeks prior to Week 6 per treatment|Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.|||minute||Standard Error|Mean
2563079|NCT02629965|Secondary|Average Daily Duration (Minutes) of ≥ 3 Metabolic Equivalents (METs)|At day 43 adjusted mean (SE) of average daily duration [minute] of ≥ 3 METs treatment comparisons measured by the activity monitor in 2 weeks prior to Week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis.|2 weeks prior to Week 6 per treatment|Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.|||minute||Standard Error|Mean
2563080|NCT02629965|Secondary|Average Daily Duration (Minutes) of ≥ 4 Metabolic Equivalents (METs)|At day 43 adjusted mean (SE) of average daily duration [minute] of ≥ 4 METs treatment comparisons measured by the activity monitor in the 2 weeks prior to week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis.|2 weeks prior to Week 6 per treatment|Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.|||minute||Standard Error|Mean
2563081|NCT02629965|Secondary|Average Number of Step Per Day (Step/Day)|At day 43 adjusted mean (SE) of average number of step per day [step/day] treatment comparisons in measured by the activity monitor in 2 weeks prior to Week 6 of each treatment. Adjusted mean was entered instead of mean in statistical analysis.|2 weeks prior to Week 6 per treatment|Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.|||step/day||Standard Error|Mean
2563082|NCT02629965|Secondary|6-minute Walk Distance [Meter]|6−minute walk distance [Meter] treatment comparisons after 6 weeks of each treatment. Adjusted mean was entered instead of mean in statistical analysis.|Day 43, 60 minutes post-dose after 6 weeks of each treatment|Full analysis set (FAS): FAS includes participants who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint or a secondary endpoint. The FAS was used for the efficacy analyses.|||Meter (m)||Standard Error|Mean
2563084|NCT02629861|Secondary|Participants With Positive Electronic Columbia Suicide Severity Rating Scale Results After the First Dose of Study Drug|The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) was used to assess the patient's suicidal ideation (severity and intensity) and behavior (Posner et al 2011). The eC-SSRS Baseline/Screening version was completed by the patient at visit 2, and the eC-SSRS Since Last Visit version was completed by the patient at all other time points. Any positive findings on the eC-SSRS Since Last Visit version required evaluation by a physician or doctoral-level psychologist. Findings after the first dose of study drug using the eC-SSRS Since Last Visit version are summarized.|Day 1 to Week 12|Safety population|||Participants|||Count of Participants
2563085|NCT02629861|Secondary|Injection Site Reaction Adverse Events|Counts of participants who reported treatment-emergent injection site reactions as AEs are summarized. Preferred terms from MedDRA version 18.1 are offered without a threshold applied.|Day 1 to Week 12|Safety population|||Participants|||Count of Participants
2563086|NCT02629861|Secondary|Prothrombin Time Shifts From Baseline to Endpoint|Shifts in prothrombin time from baseline to endpoint were summarized using patient counts grouped into three categories: - Low (below normal range) - Normal (within the normal range of 9.4 to 12.5 seconds) - High (above normal range) Shift format is: baseline finding / endpoint finding|Baseline (Day 0), Treatment Endpoint (Week 12)|Safety population of participants with both baseline and posttreatment values|||Participants|||Count of Participants
2563087|NCT02629861|Secondary|Participants With Urinalysis Laboratory Tests Potentially Clinically Significant Abnormal Results|Urinalysis with potentially clinically significant abnormal findings included: - Blood: >=2 unit increase from baseline - Urine Glucose (mg/dL): >=2 unit increase from baseline - Ketones (mg/dL): >=2 unit increase from baseline - Urine Protein (mg/dL): >=2 unit increase from baseline|Treatment Days 28, 56 and 84. Changes from previous reading reflect the baseline reading performed on Day 0.|Safety population of participants with at least one postbaseline result for the tests|||Participants|||Count of Participants
2563088|NCT02629861|Secondary|Participants With Serum Chemistry and Hematology Potentially Clinically Significant Abnormal Results|Serum chemistry and hematology laboratory tests with potentially clinically significant abnormal findings included: - Blood Urea Nitrogen (BUN) High: >=10.71 mmol/L - Bilirubin High: >=34.2 umol/L - Alanine Aminotransferase (ALT): >=3*upper limit of normal (ULN) - Aspartate Aminotransferase (AST): >=3*upper limit of normal (ULN) - Gamma Glutamyl Transferase (GGT): >=3*upper limit of normal (ULN) - Hemoglobin: Male: <115 g/L or Female: <=95 g/L - Hematocrit: Male: <0.37 L/L or Female: <0.32 L/L - Leukocytes: >=20*10^9/L or <=3*10^9/L - Eosinophils/Leukocytes: >=10% - Platelets: >=700*10^9/L or <=75*10^9/L|Treatment Days 28, 56 and 84 (or early withdrawal)|Safety population of participants with at least one postbaseline result for the tests.|||Participants|||Count of Participants
2563089|NCT02629861|Secondary|Participants With Vital Signs Potentially Clinically Significant Abnormal Values|Vital signs were performed before other assessments (eg, blood draws and administration of questionnaires). Vital signs with at least one participant showing potentially clinically significant abnormal findings included: - Pulse Rate Low: <=50 and decrease of >=15 beats per minute - Systolic Blood Pressure Low: <=90 mmHg and decrease of >=20 mmHg - Diastolic Blood Pressure High: >=105 mmHg and increase of >=15 mmHg - Diastolic Blood Pressure Low: <=50 mmHg and decrease of >=15 mmHg - Respiratory Rate Low: <10 breaths / minute|Treatment Days 28, 56 and 84. Changes from previous reading may reflect the baseline reading performed on Day 0.|Safety population of participants with both baseline and post-treatment values for each vital sign.|||Participants|||Count of Participants
2563090|NCT02629861|Secondary|Electrocardiogram Finding Shifts From Baseline to Overall|12-lead ECGs were performed before other assessments (eg, blood draws and administration of questionnaires) and performed in triplicate. The worst post-baseline finding for the patient is summarized. Only patients with both baseline and post-baseline ECGs are included. The ECG was evaluated by the investigator at the time of recording (signed and dated), and the printout was kept in the source documentation file. When potentially clinically significant findings were detected by the investigator, a cardiologist at a central diagnostic center was consulted for a definitive interpretation. Any ECG finding that was judged by the investigator as a potentially clinically significant change (worsening) compared with a baseline value was considered an adverse event. - NCS = abnormal, not clinically significant - CS = abnormal, clinically significant Shift format is: baseline finding / worst post-baseline finding|Baseline (Day 0), Treatment Week 12 (or early withdrawal)|Safety population of participants with both baseline and post-treatment ECGs|||Participants|||Count of Participants
2563091|NCT02629861|Secondary|Change From Baseline in Migraine-Related Disability Score (MIDAS), As Measured by the Migraine Disability Assessment At 4 Weeks After the Last (3rd) Dose of Study Drug|The MIDAS questionnaire is a 5-item instrument developed to assess headache-related disability based on lost days of activity in 3 domains (work, household work, and nonwork) over the previous 3 months. The total score, ie, the sum of the # lost days answered for the first 5 questions, is used for grading of disability, with scores of 0-5 lost days = grade 1 (little or no disability), 6-10 lost days =grade 2 (mild disability), 11-20 lost days = grade 3 (moderate disability), and ≥21 lost days interpreted as grade 4 (severe disability). Negative change from baseline scores indicate a reduction (improvement) in headache-related disability.|Baseline (Day 0), Treatment Week 12 (4 weeks after the 3rd dose)|Full analysis set|||lost days||Inter-Quartile Range|Median
2563092|NCT02629861|Secondary|Change From Baseline in the Monthly Average Number of Migraine Days During the 12 Week Period After the First Dose of Study Medication in Patients Not Receiving Concomitant Preventive Migraine Medications|A subset of patients (specified in the protocol not to exceed 30%) were allowed to use 1 concomitant migraine preventive medication. This outcome only includes those participants who did not take concomitant preventive migraine medication during this study. A migraine day has been previously defined. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The change is calculated as postbaseline value - baseline value.|Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)|Full analysis set of participants who did not receive concomitant migraine prevention medication|||days||Inter-Quartile Range|Median
2563115|NCT02629354|Primary|Cmax of Ibuprofen|This outcome measure presents the Cmax of ibuprofen in plasma obtained directly from the concentration-time data.|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563093|NCT02629861|Secondary|Change From Baseline in the Number of Migraine Days During the 4 Week Period After the First Dose of Study Drug|A migraine day was defined as when at least 1 of the following situations occurred: - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for migraine with or without aura - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing - a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds) Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The change is calculated as postbaseline value - baseline value.|Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 4)|Full analysis set; includes participants with observations|||days||Inter-Quartile Range|Median
2563094|NCT02629861|Secondary|Change From Baseline in the Monthly Average Number of Days of Use of Any Acute Headache Medicine During the 12 Week Period After the First Dose of Study Drug|Patients recorded any migraine medications (name of drug, number of tablets/capsules, and the dose in milligrams per tablet/capsule) taken on each day in their electronic headache diary device. Acute migraine-specific medication included triptans or ergots. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The change is calculated as postbaseline value - baseline value.|Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)|Full analysis set|||days||Inter-Quartile Range|Median
2563095|NCT02629861|Secondary|Percentage of Participants With At Least 50% Reduction In Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug|Responder rates were defined as the percentage of total subjects who reached at least a 50% reduction in the monthly average of headache days (as subjectively reported by participants in the study diary) of at least moderate severity relative to the baseline period. For the overall analysis (Month 1-3), patients who discontinued early were considered nonresponders. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The percentage reduction in monthly average is calculated as: ((baseline value - postbaseline value) / baseline value) * 100|Baseline (Days -28 to Day -1), Treatment Month 1, Month 2, Month 3, Month 1-3 (Days 1 - Week 12)|Full analysis set|||percentage of participants|||Number
2563096|NCT02629861|Primary|Participants With Adverse Events|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents usual activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 12|Safety population|||Participants|||Count of Participants
2563097|NCT02629861|Primary|Change From Baseline in the Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug|A migraine day was defined as when at least 1 of the following situations occurred: - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for migraine with or without aura - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing - a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds) Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The change is calculated as postbaseline value - baseline value.|Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)|Full analysis set|||days||Inter-Quartile Range|Median
2563098|NCT02629822|Secondary|Time to Loss of Virologic Response|The time to loss of virologic response (TLOVR) was reported. For participants who achieved HIV-1 RNA <50 copies/mL of plasma and subsequently had two consecutive HIV-1 RNA values of ≥50 copies/mL measured at least 1 week apart, TLOVR was the time between Day 1 and the date of the first of the two consecutive values ≥50 copies/mL. For participants who achieved and sustained HIV-1 RNA <50 copies/mL, time to loss of virologic response was censored at the time of the last available measurement.|Up to Week 96|All participants who experienced protocol-defined virologic failure, received ≥1 dose of MK-1439A, had baseline and later data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance mutations. Participants who did not experience virologic failure were excluded from the analysis population.|||Days||Full Range|Mean
2563099|NCT02629822|Secondary|Change From Baseline in CD4 Cell Count at Week 96|The change from baseline in CD4 cell count at Week 96 was calculated.|Baseline (Day 1) and Week 96|All participants who received ≥1 dose of MK-1439A, had baseline and Week 96 data for CD4 cell count, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance mutations.|||Cells/mm^3||95% Confidence Interval|Mean
2563100|NCT02629822|Secondary|Change From Baseline in CD4 Cell Count at Week 48|The change from baseline in CD4 cell count at Week 48 was calculated.|Baseline (Day 1) and Week 48|All participants who received ≥1 dose of MK-1439A, had baseline and Week 48 data for CD4 cell count, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance mutations.|||Cells/mm^3||95% Confidence Interval|Mean
2563101|NCT02629822|Secondary|Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 96|The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit. Participants with reading below the LoQ were considered to have <40 copies/mL.|Week 96|All participants who received ≥1 dose of MK-1439A, had baseline and Week 96 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance mutations.|||Percentage of Participants||95% Confidence Interval|Number
2563102|NCT02629822|Secondary|Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 48|The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit. Participants with reading below the LoQ were considered to have <40 copies/mL.|Week 48|All participants who received ≥1 dose of MK-1439A, had baseline and Week 48 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance mutations.|||Percentage of Participants||95% Confidence Interval|Number
2563103|NCT02629822|Secondary|Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 96|The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit.|Week 96|All participants who received ≥1 dose of MK-1439A, had baseline and Week 96 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance mutations.|||Percentage of Participants||95% Confidence Interval|Number
2563104|NCT02629822|Primary|Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 96|The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.|Up to Week 96|All participants who received ≥1 dose of MK-1439A.|||Percentage of Participants|||Number
2563105|NCT02629822|Primary|Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 96|The percentage of participants experiencing ≥1 AE up to Week 96 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.|Up to Week 96|All participants who received ≥1 dose of MK-1439A.|||Percentage of Participants|||Number
2563106|NCT02629822|Primary|Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 48.|The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.|Up to Week 48|All participants who received ≥1 dose of MK-1439A.|||Percentage of Participants|||Number
2563107|NCT02629822|Primary|Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 48|The percentage of participants experiencing ≥1 AE up to Week 48 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined.|Up to Week 48|All participants who received ≥1 dose of MK-1439A.|||Percentage of Participants|||Number
2563108|NCT02629822|Primary|Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 48|The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit.|Week 48|All participants who received ≥1 dose of MK-1439A, had baseline and Week 48 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI resistance mutations.|||Percentage of Participants||95% Confidence Interval|Number
2563109|NCT02629354|Secondary|AUC0-INF of Ibuprofen|This outcome measure presents the area under the plasma concentration of ibuprofen versus time curve, with extrapolation to infinity (AUC0-INF).|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563110|NCT02629354|Secondary|AUC0-INF of R-ibuprofen|This outcome measure presents the area under the plasma concentration of R-ibuprofen versus time curve, with extrapolation to infinity (AUC0-INF).|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563111|NCT02629354|Primary|AUC0-t of Ibuprofen|This outcome measure presents the area under the plasma concentration of ibuprofen versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t).|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563112|NCT02629354|Primary|AUC0-t of R-ibuprofen|This outcome measure presents the area under the plasma concentration of R-ibuprofen versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t).|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563113|NCT02629354|Secondary|Area Under the Plasma Concentration of S-ibuprofen Versus Time Curve, With Extrapolation to Infinity (AUC0-INF)|This outcome measure presents the area under the plasma concentration of S-ibuprofen versus time curve, with extrapolation to infinity (AUC0-INF).|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563114|NCT02629354|Primary|Area Under the Plasma Concentration of S-ibuprofen Versus Time Curve, From Time Zero to t (AUC0-t)|This outcome measure presents the area under the plasma concentration of S-ibuprofen versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t).|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|PK population|||hour (h)*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563985|NCT02615535|Secondary|Change in Beck Depression Inventory-II|Subjects respond to questions on a Likert scale from 0-3 regarding depressive symptoms. There are 21 items. Scores range from 0-63. Lower scores mean a better outcome.|baseline and six weeks||||score on a scale||Standard Error|Mean
2563117|NCT02629354|Primary|Maximum Observed Plasma Concentration (Cmax) of S-ibuprofen|This outcome measure presents the maximum observed concentration (Cmax) of S-ibuprofen in plasma obtained directly from the concentration-time data.|Within 2 hours prior to dosing and at 5, 10,15, 30 and 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours post-dose|Pharmacokinetic (PK) population: all subjects who completed the PK sampling in both periods and with no major protocol deviations considered to impact on the analysis of the PK data were included.|||nanogram (ng)/ millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
2563118|NCT02629159|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:~≥ 70% improvement in 68-tender joint count;~≥ 70% improvement in 66-swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 12|Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2563119|NCT02629159|Secondary|Percentage of Participants With No Radiographic Progression at Week 26|"No radiographic progression is defined as a change from Baseline in mTSS ≤ 0. The mTSS measures the level of joint damage from radiographs of the hands and feet, which were assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score and ranges from 0 (normal) to 448 (worst).~Joint erosion severity was assessed in 16 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).~Joint space narrowing (JSN) was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst)."|Baseline and Week 26|Full analysis set participants with available data at Baseline; linear extrapolation was used for participants who discontinued prior to Week 26 or who were rescued prior to Week 26.|||percentage of participants||95% Confidence Interval|Number
2563120|NCT02629159|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 12|"Participants were asked to indicate the severity of their arthritis pain within the previous week on a visual analog scale (VAS) from 0 to 100. A score of 0 indicates no pain and a score of 100 indicates worst possible pain. A negative change from Baseline indicates improvement."|Baseline and Week 12|Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.|||mm||95% Confidence Interval|Least Squares Mean
2563121|NCT02629159|Secondary|Change From Baseline in in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)|The FACIT Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from Baseline indicates improvement.|Baseline and Week 12|Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.|||units on a scale||95% Confidence Interval|Least Squares Mean
2563122|NCT02629159|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 12|Participants were asked to indicate the time it took for them to get as limber as possible after awakening with morning stiffness over the past 7 days. A negative change from Baseline indicates improvement.|Baseline and Week 12|Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.|||minutes||95% Confidence Interval|Least Squares Mean
2563123|NCT02629159|Secondary|Percentage of Participants Achieving Low Disease Activity Based on CDAI at Week 12|"Low disease activity based on the clinical disease activity index (CDAI) is defined as a CDAI score ≤ 10.~CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity."|Week 12|Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom CDAI data were missing at Week 12 were considered non-responders|||percentage of participants||95% Confidence Interval|Number
2563124|NCT02629159|Secondary|Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12|"The DAS28(CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.~A DAS28(CRP) score less than or equal to 3.2 indicates low disease activity."|Week 12|Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2563125|NCT02629159|Secondary|Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12|"The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).~The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from baseline score indicates an improvement."|Baseline and Week 12|Full analysis set participants with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases to Week 12 was used.|||units on a scale||95% Confidence Interval|Least Squares Mean
2563126|NCT02629159|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:~≥ 50% improvement in 68-tender joint count;~≥ 50% improvement in 66-swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 12|Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2563127|NCT02629159|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12|"The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.~A negative change from Baseline in the overall score indicates improvement."|Baseline and Week 12|Full analysis set participants with available data at baseline; multiple imputation was used for missing data.|||units on a scale||95% Confidence Interval|Least Squares Mean
2563128|NCT02629159|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 26|"The mTSS measures the level of joint damage from radiographs of the hands and feet, assessed by 2 independent, blinded readers. mTSS is calculated as the sum of the total joint erosion score and total joint space narrowing (JSN) score.~Joint erosion severity was assessed in 16 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 280 (worst).~JSN was assessed in 15 joints of each hand and wrist, and 6 joints of each foot, including subluxation, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 168 (worst).~The mTSS is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 448 (worst). A negative change from Baseline in mTSS indicates improvement in joint damage whereas a change from Baseline greater than 0 indicates progression."|Baseline and Week 26|Full analysis set participants with available data at Baseline; linear extrapolation was used for participants who discontinued prior to Week 26 or who were rescued prior to Week 26.|||units on a scale||95% Confidence Interval|Least Squares Mean
2563129|NCT02629159|Secondary|Change From Baseline in DAS28 (CRP) at Week 12|The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.|Baseline and Week 12|Full analysis set participants with available data at Baseline; multiple imputation was used for missing post-baseline data.|||units on a scale||95% Confidence Interval|Least Squares Mean
2563130|NCT02629159|Primary|Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12|"The primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was clinical remission, based on a Disease Activity Score 28 (DAS28)-CRP score of < 2.6 at Week 12.~The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.~A DAS28 score less than 2.6 indicates clinical remission."|Week 12|Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom DAS28 data were missing at Week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2563131|NCT02629159|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12|"The primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was ACR 20% response (ACR20) at Week 12. Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:~≥ 20% improvement in 68-tender joint count;~≥ 20% improvement in 66-swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 12|Full analysis set; participants who prematurely discontinued from study drug prior to Week 12 or for whom ACR data were missing at Week 12 were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2563132|NCT02629133|Secondary|Safety Behavior Checklist (SBC)|Safety Behavior Checklist (SBC) has 15 items that assess the use of strategies suggested to keep victim safe (e.g., hiding money and extra clothing). Scores range from 0 to 15; higher scores are better (indicating more safety behaviors used).|Assessed at baseline, and again at 3 and 6 months after shelter release||||score on a scale||Standard Deviation|Mean
2563133|NCT02629133|Secondary|The Cyber Stalking Scale|The Cyber Stalking Scale measure is a 6 -item measure and assesses the use of technologies in stalking and harassment. Scores range from 0 to 12. Lower is better (indicated less Cyber Stalking).|Assessed at baseline, and again at 3 and 6 months later||||score on a scale||Standard Deviation|Mean
2563134|NCT02629133|Secondary|The Composite Abuse Scale (CAS)|"The CAS is a widely used self-report of behaviors scale with 4 subscales that measure severe, combined abuse, emotional abuse, physical abuse, and harassment. The CAS has recently been published in the Centers for Disease Control and Prevention compendium of intimate partner violence measures. It consists of 30 items presented in a six point format requiring respondents to answer never, only once, several times, monthly, weekly or daily in a twelve month period. Below we present the CAS victimization scores. Scores range from 0 to 145; higher scores are worse."|Assessed at baseline, and again at 3 and 6 months after shelter release||||score on a scale||Standard Deviation|Mean
2563135|NCT02629133|Secondary|The Treatment Services Review (TSR)|The Treatment Services Review will be used to assess total times using substance use services (both treatment and self-help utilization) received (including outpatient, day patient, residential treatment, NA, AA) to capture the extent to which women are reaching out to access recovery-related resources. The TSR will assess number of times attending substance use services, divided by the number of days in the reporting period.|Assessed at baseline, and again at 3 and 6 months later||||times using substance use services/day||Standard Deviation|Median
2563136|NCT02629133|Primary|Alcohol and Substance Use: Timeline Follow-back (TLFB)-Modified Computer Version|The computer-based TLFB will assess drug use and heavy drinking (4+ standard drinks) days for the past week and the past 90 days. For primary analysis, days using drugs and heavy drinking days will be combined to create a single variable that reflects the total number of days that women used drugs or had 4+ drinks. The primary outcome is substance use (heavy drinking or drug using) days over a 6 month post shelter period. We are assessing the change of this number from baseline to 3 months post shelter, and from baseline 6 months post shelter.|Assessed at baseline, and at 3 and 6 months post shelter||||% days of drug use or heavy drinking||Standard Deviation|Median
2563137|NCT02629094|Primary|Improvement of Hepatic Steatosis: Mean Change in Hepatic Percentage of Lipid by MR Spectroscopy|Mean change in hepatic percentage of lipid by MR spectroscopy. This was calculated by subtracting the baseline hepatic percentage value of lipid from the week 24 hepatic percentage value of lipid by MR spectroscopy.|24 weeks|Analyses included participants who completed 24 weeks on study drug eplerenone.|||percentage of lipid||Standard Deviation|Mean
2563138|NCT02629094|Primary|Improvement of Cardiac Steatosis: Mean Change in Intraventricular Septum Percentage of Lipid by MR Spectroscopy.|Mean change in intraventricular septum percentage of lipid by MR spectroscopy. This was calculated by subtracting the baseline intraventicular septum percentage value of lipid from the week 24 intraventicular septum percentage value of lipid by MR spectroscopy.|24 weeks|Analyses included participants who completed 24 weeks on study drug eplerenone.|||percentage of lipid||Standard Deviation|Mean
2563139|NCT02628964|Secondary|Number of Participants Experiencing Withdrawal Symptoms|No data displayed because Outcome Measure has zero total participants analyzed.|Up to 12 weeks|no data were collected for this Outcome Measure||||||
2563140|NCT02628964|Secondary|Number of Nicotine Urges/Cravings||Up to 12 weeks|no data were collected for this Outcome Measure||||||
2563141|NCT02628964|Secondary|Percentage Satisfaction Rating for the E-cigarettes|"Percent of participants who reported either Strongly Agree or Agree to liking using e-cigarettes at 3-weeks"|3 weeks||||percentage of participants|||Number
2563142|NCT02628964|Secondary|Number of Participants Using Additional Tobacco Products and/or Marijuana||Up to 12 weeks|no data were collected for this Outcome Measure||||||
2563143|NCT02628964|Secondary|Percent of Participants in Each Arm Who Reported Side Effects|Percentage of participants who responded yes to a yes/no question about experiencing any side effects|3 weeks||||percentage of participants|||Number
2563144|NCT02628964|Primary|Proportion of Participants Who Achieve 50% Reduction in Number of Cigarettes Per Day at 3 Weeks.|Using the percent difference in number of cigarettes per day from baseline to 3-weeks, the proportion of participants who reduced their cigarette usage per day by 50% or greater|up to 3 weeks||||proportion of participants|||Number
2563145|NCT02628964|Primary|Changes in the Number of Cigarettes Per Day (CPD)||Baseline up to 3 weeks||||cigarettes per day (CPD)||Standard Deviation|Mean
2563146|NCT02628938|Secondary|Self-assessment of Mouth Odor After 7 Days of Use|"Participants were asked to score their own halitosis on a continuous 10-cm visual analogue scale that is marked as no odor on the 0-cm end, and as extremely foul odor on the 10-cm end"|After 7 days of first use||||units on a scale||Standard Deviation|Mean
2563147|NCT02628938|Secondary|Volatile Sulfur Compound Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect)|Scores using breath checker device (Tanita FitScan HC-212SF Breath Checker) were recorded (0=no odor, 1=slight odor, 2=moderate odor, 3=heavy odor, 4=strong odor, 5=intense odor).|After the first use of the prescribed method by 15 minutes, and after 7 days of use||||units on a scale||Standard Deviation|Mean
2563148|NCT02628938|Primary|Organoleptic Scores After the First Use of the Prescribed Method by 15 Minutes (Masking Effect), and After 7 Days of Use (Therapeutic Effect).|"The Organoleptic scores were obtained by a calibrated judge who first tested her ability to detect and distinguish odors even at low concentrations using the Smell Identification Test (Sensonics Inc., Haddon Heights, NJ, USA).~To obtain the score, the patient was asked to close her mouth for approximately 3 minutes while breathing only from the nose. Then he/she was asked to release air from the mouth slowly. The judge kept a distance of about 10 cm between her nose and the patient's mouth to determine the score based on the intensity of the odor.~The intensity ratings of 0 to 5 score was used where Score 0 stands for No odor present, score 1 stands barely noticeable odor, score 2 stands slight but clearly noticeable odor, score 3 stands moderate odor, score 4 stands strong offensive odor and a Score 5 stands extremely foul odor."|After the first use of the prescribed method by 15 minutes, and after 7 days of use||||units on a scale||Standard Deviation|Mean
2563149|NCT02628769|Other Pre-specified|Exploratory Outcome: Levels of Serum Biomarkers Fibrinogen Before and After Treatment With Solithromycin and Placebo.||28 days|No data collected for this Outcome due to early termination of the trial||||||
2563150|NCT02628769|Other Pre-specified|Exploratory Outcome: Levels of the Serum Biomarker C-reactive Protein Before and After Treatment With Solithromycin and Placebo.||28 days|No data collected for this Outcome due to early termination of the trial||||||
2563151|NCT02628769|Other Pre-specified|Exploratory Outcome: Activity of NF-κB in Sputum Macrophages From Patients, Before and After Treatment With Solithromycin and Placebo.||28 days|No data collected for this Outcome due to early termination of the trial||||||
2563152|NCT02628769|Other Pre-specified|Exploratory Outcome: Activity of PI3K in Sputum Macrophages From Patients, Before and After Treatment With Solithromycin and Placebo.||84 days|No data collected for this Outcome due to early termination of the trial||||||
2563153|NCT02628769|Other Pre-specified|Exploratory Outcome: Activity of HDAC2 in Sputum Macrophages From Patients, Before and After Treatment With Solithromycin and Placebo.||28 days|No data collected for this Outcome due to early termination of the trial||||||
2563154|NCT02628769|Secondary|The Number of Adult COPD Patients With Treatment-related Adverse Events, as Assessed by CTCAE v4.0.||28 days||||Participants|||Count of Participants
2563155|NCT02628769|Secondary|COPD Assessment Test (CAT) Scores|"COPD Assessment Test (CAT) scores after treatment with solithromycin and placebo.~score of 0-40 to indicate the impact of the disease, the higher score better outcome"|28 days|Due to the early termination of the study, there were too few subjects and data collected to perform statistical analysis|||score on a scale||Standard Error|Mean
2563156|NCT02628769|Secondary|R5-R20 After Treatment at 28 Days|R5-R20 assessed by impulse oscillometry after treatment with solithromycin and placebo.|28 days|Due to the early termination of the study, there were too few subjects and data collected to perform statistical analysis|||kiloPascals per liter per second||Standard Error|Mean
2563157|NCT02628769|Secondary|FEV1 After Treatment With Solithromycin and Placebo at 28 Days||28 days|Due to the early termination of the study, there were too few subjects and data collected to perform statistical analysis|||litre||Standard Error|Mean
2563158|NCT02628769|Secondary|Concentrations of CXCL8 in Nasal Lining Fluid With Solithromycin and Placebo at 28 Days||28 days|Due to the early termination of the study, there were too few subjects and data collected to perform statistical analysis|||ng/ml||Standard Error|Mean
2563159|NCT02628769|Secondary|Concentrations of Sputum TNF-α Before and After Treatment With Solithromycin and Placebo.||28 days|No data collected for this Outcome due to early termination of the trial||||||
2563160|NCT02628769|Secondary|Concentrations of Sputum MCP-1 Before and After Treatment With Solithromycin and Placebo.||28 days|No data collected for this Outcome due to early termination of the trial||||||
2563161|NCT02628769|Secondary|Concentrations of Sputum MMP-9 Before and After Treatment With Solithromycin and Placebo at 28 Days||28 days|No data collected for this Outcome due to early termination of the trial||||||
2563162|NCT02628769|Secondary|Concentrations of Sputum MPO Before and After Treatment With Solithromycin and Placebo at 28 Days||28 days|No data collected for this Outcome due to early termination of the trial||||||
2563163|NCT02628769|Secondary|Concentrations of Sputum IL-6 Before and After Treatment With Solithromycin and Placebo at 28 Days||28 days|No data collected for this Outcome due to early termination of the trial||||||
2563164|NCT02628769|Secondary|Concentrations of Sputum CXCL8 at 28 Days|Concentrations of sputum CXCL8 after treatment with solithromycin and placebo.|28 days|Due to the early termination of the study, there were too few subjects and data collected to perform statistical analysis|||ng/ml||Standard Error|Mean
2563165|NCT02628769|Primary|Number of Sputum Neutrophils Per mL at 28 Days|A number of sputum neutrophils per mL after treatment with solithromycin and placebo.|28 days|Due to the early termination of the study, there were too few subjects and data collected to perform statistical analysis|||10^6 cells/ml sputum||Standard Error|Mean
2563166|NCT02628743|Secondary|SMA Independence Scale (SMAIS) Score: Caregiver|The SMAIS was developed specifically for SMA in order to assess function-related independence. The SMAIS contains 29 items, assessing the amount of assistance required from another individual to perform daily activities, such as eating or transferring to/from a wheelchair. Each item is scored on a zero to four scale (with an additional option to indicate that an item is non-applicable). Item scores are summed to create the total score. The range of total score is between 0 and 116. Lower scores indicate greater dependence on another individual.|Week 104 and Week 130|Intent-to-Treat Population (ITT) includes all participants who received at least one dose of study medication and have at least one post-baseline assessment of MFM. The number analyzed represents participants who completed the questionnaire.|||score on scale||Standard Deviation|Mean
2563167|NCT02628743|Secondary|SMA Independence Scale (SMAIS) Score: Patient|The SMAIS was developed specifically for SMA in order to assess function-related independence. The SMAIS contains 29 items, assessing the amount of assistance required from another individual to perform daily activities, such as eating or transferring to/from a wheelchair. Each item is scored on a zero to four scale (with an additional option to indicate that an item is non-applicable). Item scores are summed to create the total score. The range of total score is between 0 and 116. Lower scores indicate greater dependence on another individual.|Week 104 and Week 130|Intent-to-Treat Population (ITT) includes all participants who received at least one dose of study medication and have at least one post-baseline assessment of MFM. The number analyzed represents participants who completed the questionnaire.|||score on scale||Standard Deviation|Mean
2563168|NCT02628743|Secondary|Change From Baseline in Revised Utility Index Score (SF-6D_R2): Caregiver|The SF-6D focuses on seven of the eight health domains covered by the SF-36: physical functioning, role participation (combined role-physical and role-emotional), social functioning, bodily pain, mental health, and vitality. SF-6D Health Utility Index (HUI) Score = 0 (worst measured health state) to 1 (best measured health state).|Baseline (Week 1), Weeks 26, 52, 78, 104 and 130|Intent-to-Treat Population (ITT) includes all participants who received at least one dose of study medication and have at least one post-baseline assessment of MFM. The number analyzed represents participants who completed the questionnaire.|||score on scale||Standard Deviation|Mean
2563169|NCT02628743|Secondary|Change From Baseline in SF-36 Domain Scores: Caregiver|The SF-36 was used to assess health-related quality of life at baseline and at on-treatment visits. The SF-36 consisted of 36 questions covering 8 domains (physical functioning, role-functioning physical, bodily pain, general health, vitality, social functioning, role-functioning emotional and mental health), with each domain scoring on a scale 0-100 (a score of 0 = maximum disability and a score of 100 = no disability). The range for all 8 norm-based domains was from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Baseline (Week 1), Weeks 26, 52, 78, 104 and 130|Intent-to-Treat Population (ITT) includes all participants who received at least one dose of study medication and have at least one post-baseline assessment of MFM. The number analyzed represents participants who completed the questionnaire.|||score on scale||Standard Deviation|Mean
2563196|NCT02628418|Primary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Nine Hole Peg Test at End of Inpatient Rehabilitation.|Nine Hole Peg Test (NHPT), a measure of coordination and mono-manual dexterity. It consists in collecting 9 pegs and inserting them into holes in a wooden base within a 50-sec time limit. The score is the average number of pegs inserted/tests performed.|Baseline and end of the study after 30 sessions, an average of 6 weeks||||pegs/sec||95% Confidence Interval|Mean
2563520|NCT02623803|Secondary|Overall Pain|Overall pain will be measured 30 minutes after arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.|30 minutes after arrival to PACU||||score on a scale||Standard Deviation|Mean
2563170|NCT02628743|Secondary|Change From Baseline in Short-Form 36 (SF-36) Physical Composite Scores (PCS) and Mental Composite Scores (MCS): Caregiver|The SF-36 was used to assess health-related quality of life at baseline and at on-treatment visits. The SF-36 consisted of 36 questions covering 8 domains (physical functioning, role-functioning physical, bodily pain, general health, vitality, social functioning, role-functioning emotional and mental health), with each domain scoring on a scale 0-100 (a score of 0 = maximum disability and a score of 100 = no disability). The 8 domains are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite norm-based t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status. Reported here are the Physical Composite Scores (PCS) and Mental Composite Scores (MCS).|Baseline (Week 1), Weeks 26, 52, 78, 104 and 130|Intent-to-Treat Population (ITT) includes all participants who received at least one dose of study medication and have at least one post-baseline assessment of MFM. The number analyzed represents participants who completed the questionnaire.|||score on scale||Standard Deviation|Mean
2563171|NCT02628743|Secondary|Change From Baseline in Degree Patient Caregiving Affected Productivity and Activities Using WPAI:CG Questionnaire|The WPAI:CG consists of four questions about the effects of Spinal Muscular Atrophy (SMA) on the following: employment status, hours missed due to patient caregiving, hours missed due to other reasons, hours actually worked and two questions that measure the degree to which patient caregiving affected productivity and regular daily activities. WPAI:CG outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|Baseline (Week 1), Weeks 26, 52, 78, 104 and 130|Intent-to-Treat Population (ITT) includes all participants who received at least one dose of study medication and have at least one post-baseline assessment of MFM. The number analyzed represents participants who completed the questionnaire.|||percentage of impairment||Standard Deviation|Mean
2563172|NCT02628743|Secondary|Change From Baseline in Work Time Missed, Impairment While Working, Overall Work Impairment and Activity Impairment Assessed Using WPAI:CG Questionnaire Score|The WPAI:CG consists of four questions about the effects of Spinal Muscular Atrophy (SMA) on the following: employment status, hours missed due to patient caregiving, hours missed due to other reasons, hours actually worked and two questions that measure the degree to which patient caregiving affected productivity and regular daily activities. WPAI:CG outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. The outcomes are presented for Percent work time missed (WTM), Percent impairment (IMP), Percent overall work impairment (OWI) and Percent activity impairment (AIM).|Baseline (Week 1), Weeks 26, 52, 78, 104 and 130|Intent-to-Treat Population (ITT) includes all participants who received at least one dose of study medication and have at least one post-baseline assessment of MFM. The number analyzed represents participants who completed the questionnaire.|||percentage||Standard Deviation|Mean
2563173|NCT02628743|Secondary|Change From Baseline in Hours Actually Worked and Work Hours Missed Assessed Using WPAI:CG Questionnaire|The WPAI:CG consists of four questions about the effects of SMA on the following: employment status, hours missed due to patient caregiving (HMC), hours missed due to other reasons (HMO), hours actually worked (HAW) and two questions that measure the degree to which patient caregiving affected productivity and regular daily activities.|Baseline (Week 1), Weeks 26, 52, 78, 104 and 130|Intent-to-Treat Population (ITT) includes all participants who received at least one dose of study medication and have at least one post-baseline assessment of MFM. The number analyzed represents participants who completed the questionnaire.|||hours||Standard Deviation|Mean
2563174|NCT02628743|Secondary|Number of Subjects Employed Assessed Using the Work Productivity and Activity Impairment Questionnaire: Caregiver (WPAI:CG) Questionnaire|The WPAI:CG consists of four questions about the effects of Spinal Muscular Atrophy (SMA) on the following: employment status, hours missed due to patient caregiving, hours missed due to other reasons, hours actually worked and two questions that measure the degree to which patient caregiving affected productivity and regular daily activities.|Baseline (Week 1), Weeks 26, 52, 78, 104 and 130|Intent-to-Treat Population (ITT) includes all participants who received at least one dose of study medication and have at least one post-baseline assessment of MFM. The number analyzed represents participants who completed the questionnaire.|||participants|||Number
2563175|NCT02628743|Secondary|Change From Baseline in Caregiver Proxy EQ-5D-5L VAS Score|The EQ-5D-5L is a self-reported health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Questionnaire was completed by the caregiver.|Baseline (Week 1), Weeks 26, 52, 78, 104 and 130|Intent-to-Treat Population (ITT) includes all participants who received at least one dose of study medication and have at least one post-baseline assessment of MFM. The number analyzed represents participants who completed the questionnaire.|||score on scale||Standard Deviation|Mean
2563176|NCT02628743|Secondary|Change From Baseline in EQ-5D-5L Visual Analogue Scale (EQ-5D-5L VAS) Score|The EQ-5D-5L is a self-reported health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.|Baseline (Week 1), Weeks 26, 52, 78, 104 and 130|Intent-to-Treat Population (ITT) includes all participants who received at least one dose of study medication and have at least one post-baseline assessment of MFM. The number analyzed represents participants who completed the questionnaire.|||score on scale||Standard Deviation|Mean
2563198|NCT02628418|Primary|Side Effects Using Gloreha Device|The feasibility of the device was assessed in terms of side effects (the physiotherapist was required to report any adverse events occurring during the study in regard to the use of Gloreha);|Through study completion. The specific hand intervention consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.||||side effects|||Number
2563177|NCT02628743|Secondary|Change From Baseline in Caregiver Proxy EQ-5D-5L Questionnaire Index Score - Total Score|The EQ-5D-5L is a self-reported health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. Overall scores range from 0 to 1, with low scores representing a higher level of dysfunction. The questionnaire was completed by the caregiver.|Baseline (Week 1), Weeks 26, 52, 78, 104 and 130|Intent-to-Treat Population (ITT) includes all participants who received at least one dose of study medication and have at least one post-baseline assessment of MFM. The number analyzed represents participants who completed the questionnaire.|||score on scale||Standard Deviation|Mean
2563178|NCT02628743|Secondary|Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Index Score - Total Score|The EQ-5D-5L is a self-reported health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. Overall scores range from 0 to 1, with low scores representing a higher level of dysfunction.|Baseline (Week 1), Weeks 26, 52, 78, 104 and 130|Intent-to-Treat Population (ITT) includes all participants who received at least one dose of study medication and have at least one post-baseline assessment of MFM. The number analyzed represents participants who completed the questionnaire.|||score on scale||Standard Deviation|Mean
2563179|NCT02628743|Secondary|Change From Baseline in Caregiver PedsQL Neuromuscular Module Version 3.0 Scale Score|The PedsQL Neuromuscular Module (Version 3.0) includes 25 items using self-report (ages 5 - 18) and/or parent report (ages 5 -18). The instrument covers problems related to neuromuscular disease, communication and family resources. Scale items are linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, and 4 = 0) so that higher scores indicate better health related quality of life. Questionnaire was completed by the caregiver.|Baseline (Week 1), Weeks 26, 52, 78, 104 and 130|Intent-to-Treat Population (ITT) includes all participants who received at least one dose of study medication and have at least one post-baseline assessment of MFM. Scale scores were not computed if more than 50% of items in the scale were missing.|||score on scale||Standard Deviation|Mean
2563180|NCT02628743|Secondary|Change From Baseline in PedsQL Neuromuscular Module Version 3.0 Scale Score|The PedsQL Neuromuscular Module (Version 3.0) includes 25 items using self-report (ages 5 - 18) and/or parent report (ages 5 -18). The instrument covers problems related to neuromuscular disease, communication and family resources. Scale items are linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, and 4 = 0) so that higher scores indicate better health related quality of life.|Baseline (Week 1), Weeks 26, 52, 78, 104 and 130|Intent-to-Treat Population (ITT) includes all participants who received at least one dose of study medication and have at least one post-baseline assessment of MFM. Scale scores were not computed if more than 50% of items in the scale were missing.|||score on scale||Standard Deviation|Mean
2563181|NCT02628743|Secondary|Change From Baseline in Caregiver PedsQL Generic Core Scales Version 4.0 Score|The PedsQL Generic Core Scale includes 23 items. The instrument covers physical, emotional, social and school functioning. Scale items are linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, and 4 = 0) so that higher scores indicate better health related quality of life. Questionnaire was completed by the caregiver.|Baseline (Week 1), Weeks 26, 52, 78, 104 and 130|Intent-to-Treat Population (ITT) includes all participants who received at least one dose of study medication and have at least one post-baseline assessment of MFM. Scale scores were not computed if more than 50% of items in the scale were missing.|||score on scale||Standard Deviation|Mean
2563182|NCT02628743|Secondary|Change From Baseline in Pediatric Quality of Life Questionnaire (PedsQL) Generic Core Scale Version 4.0 Score|The PedsQL Generic Core Scale includes 23 items using self-report and/or parent report (ages 5+). The instrument covers physical, emotional, social and school functioning. Scale items are linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, and 4 = 0) so that higher scores indicate better health related quality of life.|Baseline (Week 1), Weeks 26, 52, 78, 104 and 130|Intent-to-Treat Population (ITT) includes all participants who received at least one dose of study medication and have at least one post-baseline assessment of MFM.|||score on scale||Standard Deviation|Mean
2563183|NCT02628743|Secondary|Plasma Concentrations of Olesoxime|Values are reported separately for QD and BID doses. Dose increase occurred after Week 104.|Pre-dose (Hour 0) at Weeks 1, 13, 26, 39, 52, 78, 104 and 130|Included participants in the safety population that received at least one dose of the study drug and had measurable concentration values.|||ng/mL||Standard Deviation|Mean
2563184|NCT02628743|Secondary|Change From Baseline in MFM Total Score (D1+ D2 + Dimension 3 [D3]) Score|"The MFM scale evaluated motor function in three dimensions. D1 evaluates functions related to standing and transfer, D2 evaluates axial and proximal function in supine and sitting position on mat and chair and D3 evaluates distal motor function. The scoring of each task uses a 4-point Likert scale based on the participant's maximal abilities without assistance: 0, cannot initiate the task or maintain the starting position; 1, performs the task partially; 2, performs the task incompletely or imperfectly (with compensatory/uncontrolled movements or slowness); and 3, performs the task fully and normally. The scores are summed to yield a total score expressed as the percentage of the maximum possible score (the one obtained with no physical impairment); the lower the total score, the more severe the impairment."|Baseline (Week 1), Weeks 26, 52, 78, 104 and 130|ITT population includes all participants who received at least one dose of study medication and have at least one post-baseline assessment of MFM|||percentage of maximum score||Standard Deviation|Mean
2563197|NCT02628418|Primary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Motricity Index at End of Inpatient Rehabilitation|"Motricity Index, a measure of the motor function of the paretic upper limb. Motricity Index used to measure the ability to activate a muscle group to move a body segment through a range of motion and resist external force. The upper extremity motricity index includes: 1. pinch grasp, 2. elbow flexion, and 3. shoulder abduction.~The total upper extremity score involved adding one to the sum of the three actions.~The score of each action ranges from 0 (no ability) to 33 (maximal ability) with a maximum possible score=100."|Baseline and end of the study after 30 sessions, an average of 6 weeks||||units on a scale||95% Confidence Interval|Mean
2563185|NCT02628743|Secondary|Change From Baseline in Motor Function Measure (MFM) Dimension 1 (D1) + Dimension 2 (D2) Score|"The MFM scale evaluated motor function in three dimensions. D1 evaluates functions related to standing and transfer, D2 evaluates axial and proximal function in supine and sitting position on mat and chair and D3 evaluates distal motor function. The scoring of each task uses a 4-point Likert scale based on the participant's maximal abilities without assistance: 0, cannot initiate the task or maintain the starting position; 1, performs the task partially; 2, performs the task incompletely or imperfectly (with compensatory/uncontrolled movements or slowness); and 3, performs the task fully and normally. The scores are summed to yield a total score expressed as the percentage of the maximum possible score (the one obtained with no physical impairment); the lower the total score, the more severe the impairment."|Baseline (Week 1), Weeks 26, 52, 78, 104 and 130|Intent-to-Treat Population (ITT) includes all participants who received at least one dose of study medication and have at least one post-baseline assessment of MFM.|||percentage of maximum score||Standard Deviation|Mean
2563186|NCT02628743|Primary|Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)||Baseline up to approximately 3 years|Safety population included all patients who received at least one dose of study medication.|||percentage of participants|||Number
2563187|NCT02628600|Secondary|Change From Baseline (Day 1) to Month 6 and Month 12 in the 6MWT Distance|A 6-minute walk assessment of exertional capability was performed at Baseline (Day 1) and Month 6 and Month 12/EOT. The standardized protocol based on the American Thoracic Society (ATS) guidelines (http://doi.org/10.1164/ajrccm.166.1.at1102) was used. After assessments were performed for heart rate, blood pressure, pulse oximetry (SpO2), dyspnea, and overall fatigue using the Borg scale, participants were instructed to walk on a prescribed course as far as they could in 6 minutes. Pre-test assessment parameters were repeated after exertion. The maximum distance achieved and post exertion heart rate and SpO2 were compared to pre-test values. The maximum distance achieved was recorded in the electronic case report form.|From baseline to Month 12 or end of treatment|"Baseline: number of participants with data at this visit.~Change from baseline: number of participants with both baseline and 6 month scores."|||meters||Standard Deviation|Mean
2563188|NCT02628600|Secondary|Time to Culture Conversion|The time to culture conversion is defined as the date of conversion for participants achieving culture conversion is defined as the date of the first of 3-consecutive monthly negative sputum cultures. Then, the number of days to culture conversion is defined as the difference between the date of conversion and the date of first dose of LAI.|by Month 12|The Safety population was the set of all enrolled participants who received at least 1 dose of LAI.|||months||Full Range|Median
2563189|NCT02628600|Secondary|Number of Participants Achieving Culture Conversion by Month 6 and Month 12|"6 months: Converters are defined as participants who had 3 consecutive monthly MAC-negative sputum cultures by Month 6 (last opportunity to convert was at Month 4).~12 months: Converters are defined as participants who had 3 consecutive monthly MAC-negative sputum cultures by Month 12 (last opportunity to convert was at Month 10)."|by Month 6 and Month 12|Safety population|||Participants|||Count of Participants
2563190|NCT02628600|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|TEAEs are defined as those AEs that occurred on or after the date of first dose of study medication in INS-312 and within 28 days after the last dose. If it couldn't be determined whether the AE is treatment emergent due to a partial onset date, then it was classified as treatment emergent.|From baseline to 28 days after end of treatment, up to 13 months|Safety population|||participants|||Number
2563191|NCT02628418|Secondary|The Costs Involved in Using Gloreha in the Rehabilitation|Costs were calculated in terms of the time required by healthcare personnel, using the average cost per hour of a physiotherapist per total number of rehabilitation treatments per patient. The equivalent cost of the device for the period of patient treatment was calculated incorporating depreciation, considering the estimated residual value of the device with depreciation rate of 20%.. Indirect costs were not considered because these were common to both groups.|Through study completion, from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.||||Euros/patient|||Number
2563192|NCT02628418|Secondary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Quick-DASH Questionnaire at End of Inpatient Rehabilitation.|"The Arm disability was assessed of the study with the Quick version of the Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) questionnaire.~The Quick-DASH is a 19-item ordinal scale with a 5-level rating of items from 1 (no difficulty) to 5 (unable to do).~Quick-Dash can be divided into an 11-item (abilities and symptoms) and an 8-item optional work module and sports/performing arts module. In the 11-item sub-scale, the subject defines the ability to perform some actions (8 items) and the intensity of some symptoms (3 items), referring to the previous week. The total score range is from 19 (no disability) to 95 (full disability)."|Baseline and end of the study after 30 sessions, an average of 6 weeks||||units on a scale||95% Confidence Interval|Mean
2563193|NCT02628418|Secondary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Pinch Test at End of Inpatient Rehabilitation.|The Pinch test is a measure of hand strength. Each patient, at baseline and at the end of the study, repeated the test 3 times and the mean value was normalized for body mass index (BMI).|Baseline and end of the study after 30 sessions, an average of 6 weeks||||kg / (kg / m ^ 2||95% Confidence Interval|Mean
2563194|NCT02628418|Secondary|Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Grip Test at End of Inpatient Rehabilitation.|The Grip test is a measure of hand strength. Each patient, at baseline and at the end of the study, repeated the test 3 times and the mean value was normalized for body mass index (BMI).|Baseline and end of the study after 30 sessions, an average of 6 weeks||||kg / (kg / m ^ 2)||95% Confidence Interval|Mean
2563195|NCT02628418|Secondary|The Feasibility of This New Neuromotor Rehabilitation Device (Gloreha)|The feasibility of the device was assessed in terms of the level of operator difficulty for the physiotherapist in managing the device, assessed by visual analogue scale (VAS) (0 extremely simple - 10 extremely difficult). This outcome was measured only in the Gloreha Group in which patients were treated with device.|Baseline and end of the study after 30 sessions, an average of 6 weeks||||units on a scale||Standard Deviation|Mean
2563199|NCT02628418|Primary|Number of Patients Who Completed the Hand Rehabilitation Program||Through study completion. The specific hand interventionn consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.||||participants|||Number
2563200|NCT02628236|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 4||||Participants|||Count of Participants
2563201|NCT02628236|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24 hours after PDT||||Participants|||Count of Participants
2563202|NCT02628236|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline||||Participants|||Count of Participants
2563203|NCT02628236|Secondary|Scaling and Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 4||||Participants|||Count of Participants
2563204|NCT02628236|Secondary|Scaling and Dryness at Visit 4|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24 hours after PDT||||Participants|||Count of Participants
2563205|NCT02628236|Secondary|Scaling and Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline||||Participants|||Count of Participants
2563206|NCT02628236|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Week 4||||Participants|||Count of Participants
2563207|NCT02628236|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|24 hours after PDT||||Participants|||Count of Participants
2563208|NCT02628236|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 Minutes after photodynamic therapy||||Participants|||Count of Participants
2563209|NCT02628236|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Intraprocedure||||Participants|||Count of Participants
2563210|NCT02628236|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline||||Participants|||Count of Participants
2563211|NCT02628236|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 4||||Participants|||Count of Participants
2563212|NCT02628236|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24 hours after PDT||||Participants|||Count of Participants
2563213|NCT02628236|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 Minutes after PDT||||Participants|||Count of Participants
2563214|NCT02628236|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline||||Participants|||Count of Participants
2563521|NCT02623803|Secondary|Pain With Coughing|Pain with coughing will be measured upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.|baseline - arrival at the PACU||||score on a scale||Standard Deviation|Mean
2563215|NCT02628236|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 4||||Participants|||Count of Participants
2563216|NCT02628236|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24 hours after PDT||||Participants|||Count of Participants
2563217|NCT02628236|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 Minutes after PDT||||Participants|||Count of Participants
2563218|NCT02628236|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline||||Participants|||Count of Participants
2563219|NCT02628236|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 4||||Participants|||Count of Participants
2563220|NCT02628236|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|24 hours after PDT||||Participants|||Count of Participants
2563221|NCT02628236|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Baseline||||Participants|||Count of Participants
2563222|NCT02628236|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 4||||Participants|||Count of Participants
2563223|NCT02628236|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24 hours after PDT||||Participants|||Count of Participants
2563224|NCT02628236|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline||||Participants|||Count of Participants
2563225|NCT02628236|Primary|AUCt/AUCBL for PpIX|The ratio of AUCt to AUCBL for PpIX|0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose||||ratio||95% Confidence Interval|Geometric Mean
2563226|NCT02628236|Primary|AUCt for PpIX|The area under the observed plasma concentration time-curve from time 0 to the last quantifiable plasma concentration.|0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose||||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2563227|NCT02628236|Primary|AUCBL for PpIX|The area under the concentration time-curve assuming the baseline observed plasma concentration existed from time 0 to tlast.|0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose||||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2563228|NCT02628236|Primary|Time at Which Cmax is Attained (Tmax) for PpIX|Time of the maximum baseline corrected plasma concentration for PpIX measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value.|2 days|One subject had tmax that could not be determined.|||hours||Full Range|Median
2563294|NCT02626611|Secondary|The Number of Participants Able to Tolerate an Oral Dose of 2,000mg Each of 3 Allergens (When Applicable) Separately at Week 36, Will be Reported.|Number of FA participants who pass a DBPCFC to 2,000 mg each of 3 allergens (when applicable) (i.e. no reaction of grade 1 or more according to Bock's criteria) at week 36, will be reported.|36 weeks|Number of participants analyzed reflects only those participants with 3 or more food allergies.|||Participants|||Count of Participants
2563229|NCT02628236|Primary|Maximum Baseline Corrected Plasma Concentration (Cmax) for PpIX|Maximum baseline corrected plasma concentration (Cmax) for PpIX over the 48 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.|2 days|For 50% of the subjects, more than 50% of the PpIX plasma concentrations following topical application of ALA HCI were less than the predose plasma concentration. Therefore, negative values were set to 0 to evaluate median baseline corrected plasma concentration.|||ng/mL||Full Range|Median
2563230|NCT02628236|Primary|The Terminal Exponential Half-life (T1/2,z) for ALA|The terminal slope was calculated by linear least squares regression of the log plasma concentration-time data. The terminal exponential half-life (T1/2,z) will be calculated as 0.693 divided by the absolute value of slope.|2 days|T1/2,z could not be determined in 11 subjects|||hours||Geometric Coefficient of Variation|Geometric Mean
2563231|NCT02628236|Primary|AUCt|AUCt is the area under the baseline corrected plasma concentration-time profile up to the last quantifiable/non-negative plasma concentration|0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24 hours post-dose||||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2563232|NCT02628236|Primary|Time at Which Cmax is Attained (Tmax) for ALA|Time of the maximum baseline corrected plasma concentration for ALA measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value.|2 days||||hours||Full Range|Median
2563233|NCT02628236|Primary|Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA|Maximum baseline corrected plasma concentration (Cmax) for ALA over the 24 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.|2 days||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563234|NCT02628106|Primary|the Change of Tissue Content of Deoxyhemoglobin Assessed by BOLD-MRI|the R2* value at the time after 14days of lipo-PGE1 intravenously minus the value at the baseline，R2* is a measure of the tissue content of deoxyhemoglobin. Which is inversely proportional to oxygen content in tissue|baseline and after 14days of lipo-PGE1 intravenously|A random sample, west China hospital, in accord with a standard 21 people,age > 18 years|||1/ms||Standard Deviation|Mean
2563235|NCT02628093|Secondary|Operative Procedure Time|operative procedure time measured in minutes from the start of the incision to the last stitch in the closure of the surgical incision|Day 0 Surgical Procedure||||minutes||Full Range|Median
2563236|NCT02628093|Secondary|Delayed Thermal Injuries Related to Energy Devices|"Delayed thermal injuries related to Energy devices that occur after surgery within 30 days of the surgical date, measured as categorical variables Yes or No."|DAY 1 to DAY 30 Postsurgery||||percentage of total number in the group|||Number
2563237|NCT02628093|Secondary|Intraoperative Complication Related to the Energy Devices|"Intraoperative adverse event occurrences during surgery due to the energy devices (THUNDERBEAT and LigaSure) measured as categorical variable Yes or No"|Day 0 Surgical procedure||||percentage of total in the group|||Number
2563238|NCT02628093|Secondary|Dryness of the Surgical Field Average Score Mean/sd|Measured by score from 1 to 5 where 1 means Heavy bleeding , hemostasis achieved with the instrument with more than 2 attempts, and 5 means No oozing at vessel or tissue site in entire surgical field .|Day 0 Surgical Procedure||||score on a scale||Standard Deviation|Mean
2563239|NCT02628093|Secondary|Length of Post Surgical Stay in the Hospital|Length of post surgical stay in the hospital measured in days|from Surgery date to the discharge date from the hospital up to 30 days||||days||Standard Deviation|Mean
2563240|NCT02628093|Primary|Versatility Score|Total/Composite score (composite of 5 variables:hemostasis;sealing;cutting;dissection;and tissue manipulation) was measured by a score system from 1 to 5 (1 being worst and 5 best) for each of the 5 variables,weighted by Coefficient of Importance with weight distribution as follow: hemostasis 0.275, sealing 0.275, cutting 0.2, dissection 0.15, and tissue Manipulation 0.1.). The final reported score is a weighted average.|Day 0 Surgical procedure||||score on a scale||Standard Deviation|Mean
2563241|NCT02628093|Primary|Overall Time for Dissection of the Soft Tissues|from the start of colon mobilization to specimen removal from the abdominal cavity|Day 0 Surgical procedure||||minutes||Full Range|Median
2563242|NCT02628028|Secondary|Pharmacokinetics (PK): Clearance Parameter of LY3337641|Apparent total body clearance of drug after oral administration based on population PK analysis was evaluated. As prespecified per protocol, an overall population estimate of clearance is generated and data from Part A and B were combined for the analysis. The sparse data was then analyzed using population PK methods in Non linear Mixed Effects Model (NONMEM) to generate an overall population estimate of clearance.|Part A: Weeks 1, 2, and 4, Day 1 (0.5 to 2 hours postdose); Part B: Weeks 2, 4, 8, and 12, Day 1 (0.5 to 2 hours postdose)|All randomized participants who received at least 1 dose of the study drug and have evaluable PK data in in Part A and Part B.|||Liter per hour (L/hr)||Standard Error|Mean
2563243|NCT02628028|Secondary|Percentage of Participants Who Achieve Clinical Remission Using DAS28-hsCRP in Part B|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Clinical remission is defined as DAS28-hsCRP <2.6.|Week 12|All randomized participants who received at least 1 dose of the study drug, for participants who completed or early discontinued dosing treatment period before the study was terminated in Part B. Missing values due to discontinuation of study or drug, or missing data were imputed using non-responder imputation (NRI).|||Percentage of Participants||95% Confidence Interval|Number
2563295|NCT02626611|Secondary|The Number of Participants Able to Tolerate an Oral Dose of 4,000mg Each of 2 Allergens Separately at Week 36, Will be Reported.|Number of FA participants who pass a DBPCFC to (4,000 mg each of 2 allergens at week 36) (i.e. no reaction of grade 1 or more according to Bock's criteria) .|36 weeks||||Participants|||Count of Participants
2563706|NCT02621060|Primary|2 Hours Plasma Glucose (2-h PG)|Subjects underwent a 2-h oral glucose tolerance test (2-h OGTT) by consuming 75-g of a dextrose load, and one sample was obtained 120 min after glucose administration.|Week 12.|3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.|||mmol/L||Standard Deviation|Mean
2563244|NCT02628028|Secondary|Percentage of Participants Who Achieve Low Disease Activity Using DAS28-hsCRP in Part B|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using VAS. DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.|Week 12|All randomized participants who received at least 1 dose of the study drug, for participants who completed or early discontinued dosing treatment period before the study was terminated in Part B. Missing values due to discontinuation of study or drug, or missing data were imputed using non-responder imputation (NRI).|||Percentage of Participants||95% Confidence Interval|Number
2563245|NCT02628028|Secondary|Change From Baseline in the Disease Activity Score (DAS) 28-high-sensitivity C-reactive Protein (hsCRP) in Part B|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using VAS. DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 12|All randomized participants who received at least 1 dose of the study drug, for participants who completed or early discontinued dosing treatment period before the study was terminated in Part B. Missing values due to discontinuation of study or drug, or missing data were imputed using non-responder imputation (NRI).|||units on a scale||Standard Deviation|Mean
2563246|NCT02628028|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response in Part B|"ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. ACR70 Responder is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria:~Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient's Global Assessment of Arthritis Pain using VAS, HAQ-DI and hsCRP. Participants with missing responses and/or participants who discontinue study or drug before analysis timepoint are deemed non-responders."|Week 12|All randomized participants who received at least 1 dose of the study drug, for participants who completed or early discontinued dosing treatment period before the study was terminated in Part B. Missing values due to discontinuation of study or drug, or missing data were imputed using non-responder imputation (NRI).|||Percentage of Participants||95% Confidence Interval|Number
2563247|NCT02628028|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response in Part B|"ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria:~Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient's Global Assessment of Arthritis Pain using VAS, HAQ-DI and hsCRP. Participants with missing responses and/or participants who discontinue study or drug before analysis timepoint are deemed non-responders."|Week 12|All randomized participants who received at least 1 dose of the study drug, for participants who completed or early discontinued dosing treatment period before the study was terminated in Part B. Missing values due to discontinuation of study or drug, or missing data were imputed using non-responder imputation (NRI).|||Percentage of Participants||95% Confidence Interval|Number
2563248|NCT02628028|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response in Part B|"ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient's Global Assessment of Arthritis Pain using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI) and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and /or participants who discontinue study or drug before analysis timepoint are deemed non-responders."|Week 12|All randomized participants who received at least 1 dose of the study drug, for participants who completed or early discontinued dosing treatment period before the study was terminated in Part B. Missing values due to discontinuation of study or drug, or missing data were imputed using non-responder imputation (NRI).|||Percentage of Participants||95% Confidence Interval|Number
2563249|NCT02628028|Primary|Number of Participants With One or More Treatment-Emergent Adverse Events (TEAEs) or Adverse Events of Special Interest (AESIs) or Any Serious AEs (SAEs) in Part A|TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. Skin Rash was the only event that was considered an AESI. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of SAEs and other non-serious AEs, regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.|Up to 6 Weeks|All randomized participants who received at least 1 dose of the study drug in Part A.|||Participants|||Count of Participants
2563250|NCT02627963|Secondary|Duration of Response (DOR)|Duration of response (DOR) is defined as the time from the first documentation of objective tumor response to the first documentation of tumor progression per RECIST 1.1 or to death due to any cause.|Assessed every 8 weeks from date of randomization until date of progression|ITT Population|||Months||95% Confidence Interval|Median
2563251|NCT02627963|Secondary|Objective Response Rate (ORR)|Objective response rate (ORR) is defined as the percentage of subjects who have at least a 30% reduction in the sum of diameters per RECIST (Version 1.1).|Every 8 weeks from date of randomization until disease progression|ITT Population|||Participants|||Count of Participants
2563252|NCT02627963|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from the date of randomization to date of death due to any cause.|Date of randomization to date of death||2020-06-30|06/2020||||
2563707|NCT02621060|Primary|Fasting Plasma Glucose (FPG)|Reflect the fasting glucose level after a 10- to 12-h overnight fast.|Week 12.|3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.|||mmol/L||Standard Deviation|Median
2563253|NCT02627963|Primary|Progression-free Survival (PFS)|Progression-Free Survival (PFS), as assessed by a blinded independent radiological review (IRR), is defined as the time from randomization to first documentation of objective tumor progression (progressive disease) or death due to any reasons whichever comes first. Disease progression per RECIST 1.1 criteria is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks.|ITT Population|||Months||95% Confidence Interval|Median
2563254|NCT02627924|Secondary|Healthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid Arthritis|The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.|24 weeks|Enrolled participants who did not discontinue adalimumab during the study|||Participants|||Count of Participants
2563255|NCT02627924|Secondary|Healthcare Resource Utilization: Number of Participants With Surgery Related to Rheumatoid Arthritis|The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.|24 weeks|Enrolled participants who did not discontinue adalimumab during the study|||Participants|||Count of Participants
2563256|NCT02627924|Secondary|Healthcare Resource Utilization: Number of Participants With Hospitalization Related to Rheumatoid Arthritis|The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.|24 weeks|Enrolled participants who did not discontinue adalimumab during the study|||Participants|||Count of Participants
2563257|NCT02627924|Secondary|Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis|The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.|24 weeks|Enrolled participants who did not discontinue adalimumab during the study|||Participants|||Count of Participants
2563258|NCT02627924|Secondary|Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis|The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.|24 weeks|Enrolled participants who did not discontinue adalimumab during the study|||Participants|||Count of Participants
2563259|NCT02627924|Secondary|Patient Treatment Satisfaction|"Participants were asked to answer the following four questions as either Very satisfied, Somewhat satisfied, Neither satisfied nor dissatisfied, Somewhat dissatisfied, or Very dissatisfied.~Question 1: Satisfaction with RA treatment in improving morning stiffness in and around the joints~Question 2: Satisfaction with RA treatment improving mobility~Question 3: Satisfaction with RA treatment improving the ability to perform daily living requiring fine motor skills~Questions 4: Satisfaction with RA treatment overall"|Baseline, week 12 and week 24|Participants still receiving adalimumab and with available data at each time point.|||Participants|||Count of Participants
2563260|NCT02627924|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24|The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), overall work impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. A negative change from baseline indicates improvement.|Baseline, week 12, and week 24|Participants still receiving adalimumab and with available data at each time point. Overall work impairment was only assessed in participants who were employed.|||percent impairment||Standard Deviation|Mean
2563261|NCT02627924|Secondary|Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24|The EQ-5D-5L descriptive system comprises 5 dimensions of health-related quality of life states (mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity ('no problems', 'some problems', and 'extreme problems') within a particular EQ-5D-3L dimension. The EQ-5D-3L results were converted into a weighted health state index with scores ranging from approximately 0 (death) to 1 (full health). A positive change from baseline indicates improvement.|Baseline, week 12, and week 24|Participants still receiving adalimumab and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2563262|NCT02627924|Secondary|Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24|"The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).~The summary physical health score included the following subscales: physical functioning, role-physical, bodily pain, and general health. The summary mental health score included the following subscales: vitality, social functioning, role-emotional, and mental health.~Each score ranges from 0 to 100 where higher scores indicate a better quality of life. A positive change from Baseline score indicates an improvement."|Baseline, week 12, and week 24|Participants still receiving adalimumab and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2563263|NCT02627924|Secondary|Percentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24|"The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability.~A clinically meaningful improvement was defined as an improvement of -0.22 points or greater in the HAQ-DI score."|Baseline, week 12 and week 24|Participants still receiving adalimumab and with available data at each time point.|||percentage of participants|||Number
2563264|NCT02627924|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12|The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability.|Baseline and week 12|Participants who were still receiving adalimumab at week 24 and with available HAQ-DI data at baseline and week 12.|||units on a scale||Standard Deviation|Mean
2563265|NCT02627924|Primary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 24|The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability.|Baseline and week 24|Participants who were still receiving adalimumab at week 24 and with available HAQ-DI data at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2563266|NCT02627794|Secondary|35 Days Middle Turbinate Position|35 days middle turbinate position|Participants will be followed for the duration of post op standard of care, an expected average of 90 days.|Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.||||||
2563267|NCT02627794|Secondary|35-day Frequency of Oral Steroid Rescue|35-day frequency of oral steroid rescue|Participants will be followed for the duration of post op standard of care, an expected average of 90 days.|Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.||||||
2563268|NCT02627794|Secondary|35-day Frequency of Postoperative Interventions|35-day frequency of postoperative interventions, including lyses of adhesions and debridement.|Participants will be followed for the duration of post op standard of care, an expected average of 90 days.|Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.||||||
2563269|NCT02627794|Secondary|90-day Sinonasal Outcomes Test-22 (SNOT- 22) Scores|90-day Sinonasal Outcomes Test-22 (SNOT- 22) scores|Participants will be followed for the duration of post op standard of care, an expected average of 90 days.|Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.||||||
2563270|NCT02627794|Secondary|35 and 90-day Post ESS Incidence of Middle Meatal Synechiae|35 and 90-day post ESS incidence of middle meatal synechiae|Participants will be followed for the duration of post op standard of care, an expected average of 90 days.|Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.||||||
2563271|NCT02627794|Secondary|35 and 90-day Intraocular Pressure (IOP) Assessment|35 and 90-day intraocular pressure (IOP) assessed using applanation tonometry and compared to baseline IOP obtained preoperatively|Participants will be followed for the duration of post op standard of care, an expected average of 90 days.|Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.||||||
2563272|NCT02627794|Secondary|90-day Sinonasal Mucosal Inflammation Assessment|90-day sinonasal mucosal inflammation assessed by rigid endoscopy and graded on Lund-Kennedy sinus mucosal endoscopic staging system|Participants will be followed for the duration of post op standard of care, an expected average of 90 days.|Zero participants were analyzed as data were not significant (not enough data); Study closed prior to being able to enroll sample size (N=50) goal.||||||
2563273|NCT02627794|Primary|Incidence of Middle Meatal Synechiae After Endoscopic Sinus Surgery in Silastic and Restora Steroid Eluting Spacer.|The main objective of the trial is to evaluate basic device usability and confirm safety and effectiveness of Restora™ Mometasone Furoate eluting spacer as compared to a Silastic spacer. 35-day sinonasal mucosal inflammation will be assessed by rigid endoscopy and graded on Lund-Kennedy sinus mucosal endoscopic staging system.|Participants will be followed for the duration of post op standard of care, an expected average of 90 days.||||Participants|||Count of Participants
2563274|NCT02627144|Primary|Cumulative Dose of Immunotherapy (Interferon Alpha-2a) in Daily Routine||Up to 52 weeks|FAS. Data were not analyzed for this outcome measure as therapy doses and pattern were not recorded numerically.||||||
2563275|NCT02627144|Primary|Overall Survival (OS) Time|OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.|Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years|FAS|||months||95% Confidence Interval|Median
2563276|NCT02627144|Primary|Progression-free Survival (PFS) Time|PFS time is defined as time between start of therapy and progression or death. Kaplan-Meier estimate was used for evaluation. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|Baseline until progression or intolerable toxicity or death, whichever occurred first, assessed up to 6 years|FAS|||months||95% Confidence Interval|Median
2563277|NCT02627144|Primary|Percentage of Participants With Disease Control|Disease control was defined as having achieved CR, PR, and/or SD during the course of the observation. CR: disappearance of all target lesions and all pathological lymph nodes below 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years|FAS. ‘Number of participants analyzed’ indicate participants who were evaluable for this measure.|||percentage of participants|||Number
2563278|NCT02627144|Primary|Percentage of Participants With Best Overall Tumor Response|Tumor response was assessed as one of the following: Complete response (CR): disappearance of all target lesions and all pathological lymph nodes below 10 millimeter (mm). Partial response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions. Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions.|Baseline until progression or intolerable toxicity, whichever occurred first, assessed up to 6 years|Full analysis set (FAS) included all participants who received at least one dose of study medication and have at least one post dose efficacy assessment, following the intention-to-treat principle. 'Number of participants analyzed' indicate participants with non-missing tumor response data.|||percentage of participants|||Number
2563279|NCT02627118|Primary|BPA Level Following 2 Months of Dialysis|blood sampling of BPA (Bisphenol-A) in ng/mL following 2 months of dialysis with the Fresenius 160NR or the Nipro Elisio 15-H|2 MONTHS OF TREATMENT|When data was collected, BPA level was not measureable in one patient (lab reported the presence of unidentified “interfering substance”) and that patient’s data was removed from final analysis.|||ng/mL||Standard Error|Mean
2563280|NCT02627001|Primary|Received Minute Volume (Liters) as Measured by Wright Respirometer|An Impact 731 Ventilator will be attached to a mask. Subjects will hold a mask seal on a cadaver for 100 seconds. The Impact 731 Ventilator will then deliver standardized tidal volumes of 750 cc (delivered tidal volume) 10 times at six second intervals. A Wright respirometer will then measure received tidal volume for each of these 10 breaths.|1 Minute||||Liters||Inter-Quartile Range|Median
2563281|NCT02626910|Primary|Satisfaction With Medical Care Survey|Multinomial logistic regression models will be used to determine the degree to which people with disabilities and without have satisfaction with medical care obtained from the survey. The scale ranges from 1 (not satisfied) to 4 (very satisfied) with their medical care. Higher scores represent more satisfaction with medical care. Unit of measurement is units on a scale.|One year|Satisfaction with healthcare|||units on a scale||Standard Deviation|Mean
2563282|NCT02626819|Primary|Percent of Patients With Clinically Significant Weight Loss|The percentage of patients who achieve 5-10% weight loss at 12- month study visit.|12 months|At the 12-months, 3 participants in Arm 1 and 2 participants in Arm 2 did not complete the study visit and thus were not included in analysis.|||Participants|||Count of Participants
2563283|NCT02626819|Primary|Percent of Patients Who Achieved 2.5% Weight Loss|Percentage of patients who achieved 2.5% weight loss at 12 months. Weight measured in kg.|12 months|At the 12-months, 3 participants in Arm 1 and 2 participants in Arm 2 did not complete the study visit and thus were not included in analysis.|||Participants|||Count of Participants
2563284|NCT02626819|Primary|Percent of Patients With Clinically Significant Weight Loss|The percentage of patients who achieve 5-10% weight loss at 6- month study visit.|6 months|At the 6-months, 2 participants in Arm 1 and 1 participant in Arm 2 did not complete the study visit and thus were not included in analysis.|||Participants|||Count of Participants
2563285|NCT02626819|Primary|Percent of Patients With 2.5% Weight Loss at 6 Months.|Percentage of patients who achieved 2.5% weight loss at 6 months. Weight measured in kg.|6 months|At the 6-months, 2 participants in Arm 1 and 1 participant in Arm 2 did not complete the study visit and thus were not included in analysis.|||Participants|||Count of Participants
2563286|NCT02626819|Primary|Percent of Patients With Clinically Significant Weight Loss|The percentage of patients who achieve 5-10% weight loss at 3- month study visit.|3 months|At the 3-months, 6 participants in Arm 1 did not complete the study visits and thus were not included in analysis.|||Participants|||Count of Participants
2563287|NCT02626819|Primary|Weight Change (kg)|Change in weight from baseline to the 12-months. Two weight measurements were taken using a Medline MDR500PHY Physician Digital Scale equipped with height rod. The two weight measurements were averaged. Weight was measured in kilograms and height taken at the baseline, using these two measures Body Mass Index was calculated.|12 months|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputations to adjust for missing data|||kilograms||Standard Deviation|Mean
2563288|NCT02626819|Primary|Weight Change (kg)|Change in weight from baseline to 6-months. Two weight measurements were taken using a Medline MDR500PHY Physician Digital Scale equipped with height rod. The two weight measurements were averaged. Weight was measured in kilograms and height taken at the baseline, using these two measures Body Mass Index was calculated.|6 Months|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputation to adjust for missing data|||kilograms||Standard Deviation|Mean
2563289|NCT02626819|Primary|Weight Change (kg)|Weight Change from baseline to 3 months. Two weight measurements were taken using a Medline MDR500PHY Physician Digital Scale equipped with height rod. The two weight measurements were averaged. Weight was measured in kilograms and height taken at the baseline, using these two measures Body Mass Index was calculated.|3 Months|Weight change was analyzed using Wilcoxon Rank-Sum test along with multiple imputations to adjust for missing data.|||kilograms||Standard Deviation|Mean
2563290|NCT02626780|Secondary|Growth of New Hair|The change in hair density (number of hairs per square centimeter) from baseline to 6 months after treatment will be expressed as a percentage.|6 months|Participants that completed 6 month follow-up|||Percentage of hairs/cm^2||Standard Deviation|Mean
2563291|NCT02626780|Primary|Incidence of Treatment-emergent Adverse Events (Safety)|Subjects will be monitored for Adverse events for the duration of the study.|6 months|All participants were monitored for adverse events|||adverse events|||Number
2563292|NCT02626611|Secondary|The Number of Participants Able to Tolerate an Oral Dose of 2,000mg Each of 5 Allergens (When Applicable) Separately at Week 36, Will be Reported.|Number of FA participants who pass a DBPCFC to 2,000 mg each of 5 allergens (when applicable) (i.e. no reaction of grade 1 or more according to Bock's criteria) at week 36, will be reported.|36 weeks|Number of participants analyzed reflects only those participants with 5 or more food allergies|||Participants|||Count of Participants
2563293|NCT02626611|Secondary|The Number of Participants Able to Tolerate an Oral Dose of 2,000mg Each of 4 Allergens (When Applicable) Separately at Week 36, Will be Reported.|Number of FA participants who pass a DBPCFC to 2,000 mg each of 4 allergens (when applicable) (i.e. no reaction of grade 1 or more according to Bock's criteria) at week 36, will be reported.|36 weeks|Number of participants analyzed reflects only those participants with 4 or more food allergies|||Participants|||Count of Participants
2563296|NCT02626611|Primary|The Number of Participants Able to Tolerate an Oral Food Challenge to 2,000 mg at Least of 2 Allergens at Week 36 (i.e. the End of the Randomized Withdrawal/Tolerance Phase), Will be Reported.|Number of FA participants who pass a DBPCFC to 2,000 mg each of 2 allergens (i.e. no reaction of grade 1 or more according to Bock's criteria) at week 36, will be reported.|36 weeks||||Participants|||Count of Participants
2563297|NCT02626520|Secondary|Overall Survival|Time to death from any cause measured from start of treatment|Up to 3 years from registration|Data not collected, study terminated||||||
2563298|NCT02626520|Secondary|R-0 Rate|Rate of patients having surgery who have negative surgical margins (i.e. R-0 resection)|Time of surgery|Data not collected, study Terminated||||||
2563299|NCT02626520|Primary|Relapse Free Survival|Percentage of patients alive and free of detectable disease 1 yr from start of treatment|1 yr form onset of treatment|Due to excessive toxicity of study regimen, the study was permanently closed prior to data analysis.||||||
2563300|NCT02626182|Secondary|Cystic Fibrosis Quality of Life-Revised Respiratory Domain Score|The CFQ-R Respiratory domain score (scale 0-100 with higher scores indicating better quality of life) was assessed at weeks 1 and 13. The change in the score between week 1 and week 13 is reported.|Assessed at weeks 1 and 13|Subjects who received sildenafil 40 mg po tid or placebo tid for 12 weeks|||units on a scale||Standard Deviation|Mean
2563301|NCT02626182|Primary|Cardiopulmonary Exercise Test Work Rate|Work rate (the amount of energy being expended to cycle) was assessed at weeks 1 and 13. The change in maximum work measured during CPET between weeks 1 and 13 is reported.|Weeks 1 and 13|Patients who received sildenafil 40 mg po tid or placebo po tid for 12 weeks|||watts||Standard Deviation|Mean
2563302|NCT02626182|Primary|6 Minute Walk Distance|Change in distance walked between week 1 and week 13 were compared. The difference between the two time points is reported.|Weeks 1, 13|All subjects who received 12 weeks of sildenafil 40 mg po tid or placebo po tid with the exception of 1 extreme outlier in the placebo group who was excluded.|||meters||Standard Deviation|Mean
2563303|NCT02626000|Secondary|Number of Participants With Adverse Events|"The severity of adverse events was assessed by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, and based on the following scale:~Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death."|From first dose of study drug to 30 days after last dose; As of 02 November 2017, the median (range) duration of treatment was 5.6 (0.1 to 57.1) weeks for talimogene laherparepvec and 6.1 (0.1, 63.1) weeks for pembrolizumab.|All enrolled participants in phase 1b who received at least 1 dose of talimogene laherparepvec or pembrolizumab.|||Participants|||Count of Participants
2563304|NCT02626000|Secondary|Overall Survival|Overall survival (OS) was defined as the interval from first dose to the event of death from any cause; otherwise, OS was censored at the date the participant was last known to be alive.|Up to the data cutoff date of 02 November 2017; median (minimum, maximum) time on follow-up was 14.36 (1.4, 67.0) weeks.|Enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab, excluding participants with locoregionally advanced disease with a recurrence < 3 months after prior platinum-containing curatively intended multimodal therapy.|||months||95% Confidence Interval|Median
2563305|NCT02626000|Secondary|Progression Free Survival|Progression-free survival (iPFS) per irRECIST was defined as the interval from first dose to the earlier of a participant overall response of iPD or death from any cause; otherwise, iPFS was censored at the last evaluable tumor assessment. The initial date of an iPD that was consecutively confirmed was used.|Up to the data cutoff date of 02 November 2017; median (minimum, maximum) time on follow-up was 14.36 (1.4, 67.0) weeks.|Enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab, excluding participants with locoregionally advanced disease with a recurrence < 3 months after prior platinum-containing curatively intended multimodal therapy.|||months||95% Confidence Interval|Median
2563306|NCT02626000|Secondary|Disease Control Rate|"Disease control rate (iDCR) was defined as the percentage of participants with a best overall response of iCR or iPR or iSD assessed by the investigator using irRECIST.~Complete response (iCR): Disappearance of all lesions (whether measurable or not and whether baseline or new) and confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented was required. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial response (iPR): Decrease in tumor burden ≥ 30% relative to baseline. Confirmation by a consecutive assessment at least 4 weeks after first documentation required.~Stable disease (iSD): Neither sufficient shrinkage to qualify for iCR or iPR nor sufficient increase to qualify for iPD.~Analyses are presented below for both the unconfirmed and confirmed results."|Up to the data cutoff date of 02 November 2017; median (minimum, maximum) time on follow-up was 14.36 (1.4, 67.0) weeks.|Enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab, excluding participants with locoregionally advanced disease with a recurrence < 3 months after prior platinum-containing curatively intended multimodal therapy.|||percentage of participants||95% Confidence Interval|Number
2563307|NCT02626000|Secondary|Duration of Confirmed Response|Duration of response (iDOR) per irRECIST was defined as the time from the date of an initial response of iCR or iPR that was subsequently confirmed to the earlier of a participant overall response of iPD or death. Participants who did not end their response at the time of analysis were censored at their last evaluable tumor assessment.|Up to the data cutoff date of 02 November 2017; median (minimum, maximum) time on follow-up was 14.36 (1.4, 67.0) weeks.|Enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab, excluding participants with locoregionally advanced disease with a recurrence < 3 months after prior platinum-containing curatively intended multimodal therapy, with a best response of iCR or iPR.|||months||95% Confidence Interval|Median
2563315|NCT02625974|Other Pre-specified|Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit (Part 1)|Using frequencies of matches and mismatches to assess agreement|Up to 420 days (Visit 11) post-treatment|Subjects who have testing missed are excluded in the Number Analyzed at each visit.|||Participants|||Count of Participants
2563316|NCT02625974|Other Pre-specified|Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit (Part 1)|Using frequencies of matches and mismatches to assess agreement|Up to 420 days (Visit 11) post-treatment|Subjects who have both testing missed are excluded in the Number Analyzed in each arm.|||Participants|||Count of Participants
2563308|NCT02626000|Secondary|Best Overall Confirmed Response|"Best overall visit response of iCR, iPR, stable disease (iSD), progressive disease (iPD) or unevaluable (iUE) based on investigator assessment using irRECIST.~iCR: Disappearance of all lesions (whether measurable or not and whether baseline or new). Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm.~iPR: Decrease in tumor size ≥ 30% relative to baseline. iPD: Increase in tumor size ≥ 20% and at least 5 mm absolute increase compared to nadir or qualitative worsening of non-target lesions or a new lesion.~iSD: Neither sufficient shrinkage to qualify for iCR or iPR nor sufficient increase to qualify for iPD.~iUE: Any baseline lesion which was not assessed or was unable to be evaluated leading to an inability to determine the status of that particular tumor.~Not Done: Radiographic imaging was not performed to evaluate the response. iCR, iPR, and iPD required confirmation by a consecutive assessment at least 4 weeks after first documentation."|Up to the data cutoff date of 02 November 2017; median (minimum, maximum) time on follow-up was 14.36 (1.4, 67.0) weeks.|All enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab, excluding participants with locoregionally advanced disease with a recurrence < 3 months after prior platinum-containing curatively intended multimodal therapy.|||Participants|||Count of Participants
2563309|NCT02626000|Secondary|Complete Response Rate|"Complete response rate (iCRR) was defined as the percentage of participants with a best overall response of complete response assessed by the investigator using immune-related Response Evaluation Criteria in Solid Tumors (irRECIST). Response was based on the size of tumors assessed by computed tomography (CT) or magnetic resonance imaging (MRI).~Complete response (iCR): Disappearance of all lesions (whether measurable or not and whether baseline or new) and confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented was required. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Analyses are presented below for both the unconfirmed and confirmed results."|Up to the data cutoff date of 02 November 2017; median (minimum, maximum) time on follow-up was 14.36 (1.4, 67.0) weeks.|All enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab, excluding participants with locoregionally advanced disease with a recurrence < 3 months after prior platinum-containing curatively intended multimodal therapy.|||percentage of participants||95% Confidence Interval|Number
2563310|NCT02626000|Secondary|Objective Response Rate|"Objective response rate was defined as the percentage of participants with a best overall response of complete response or partial response assessed by the investigator using immune-related Response Evaluation Criteria in Solid Tumors (irRECIST). Response was based on the size of tumors assessed by computed tomography (CT) or magnetic resonance imaging (MRI).~Complete response (iCR): Disappearance of all lesions (whether measurable or not and whether baseline or new) and confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented was required. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial response (iPR): Decrease in tumor burden ≥ 30% relative to baseline. Confirmation by a consecutive assessment at least 4 weeks after first documentation required.~Analyses are presented below for both the unconfirmed and confirmed results."|Up to the data cutoff date of 02 November 2017; median (minimum, maximum) time on follow-up was 14.36 (1.4, 67.0) weeks.|All enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab, excluding participants with locoregionally advanced disease with a recurrence < 3 months after prior platinum-containing curatively intended multimodal therapy.|||percentage of participants||95% Confidence Interval|Number
2563311|NCT02626000|Primary|Number of Participants With a Dose Limiting Toxicity (DLT)|"The following toxicities (graded per the Common Terminology Criteria for Adverse Events v 4.0) were considered DLTs if judged by the investigator to be related to either study drug:~grade 4 non-hematologic (non-laboratory) toxicity~≥ grade 3 pneumonitis~grade 3 non-hematologic toxicity for > 3 days with optimal supportive care~grade 3 fatigue was not classified as DLT, regardless of duration~any ≥ grade 3 non-hematologic laboratory value if:~medical intervention was required,~the abnormality led to hospitalization, or~the abnormality persisted at ≥ grade 3 for > 1 week unless deemed not clinically important by investigator and sponsor~grade 3 or 4 febrile neutropenia~thrombocytopenia < 25 x 10⁹/L associated with bleeding event requiring intervention~serious herpetic event: herpetic encephalitis, encephalomyelitis, or disseminated herpetic infection~grade 5 toxicity~other intolerable toxicity leading to permanent discontinuation of either study drug."|First 6 weeks after the initial administration of talimogene laherparepvec and pembrolizumab in combination|The DLT analysis set included DLT-evaluable participants who had the opportunity to be on treatment for at least 6 weeks and had received at least 2 doses of talimogene laherparepvec and 2 doses of pembrolizumab in combination, or who had a DLT during the DLT evaluation period after at least 1 dose of both study drugs in combination.|||Participants|||Count of Participants
2563312|NCT02625974|Other Pre-specified|Relationship Between Conventional ELISA Results in Terms of Cure or No Cure and IHA Results in All Patients|"Cure is defined as sero-reduction (in subjects => 8 months to < 18 years of age at randomization) or sero-conversion (in all subjects).~Sero-reduction is defined as a => 20% reduction in optical density [OD]) measured by two conventional ELISA serology tests and sero-conversion is defined as negative Immunoglobulin G [IgG] concentration measured by two conventional ELISA serology tests."|Up to 420 days (Visit 11) post-treatment|Subjects who have both testing missed are excluded in the Overall Number of Participants Analyzed and Number Analyzed in each arm.|||Participants|||Count of Participants
2563313|NCT02625974|Other Pre-specified|Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results|Sero-reduction is defined as a => 20% reduction in optical density [OD]) using two conventional ELISA serology tests in subjects => 8 months to < 18 years of age at randomization; Others: reactive results that are not sero-reduction in subjects => 8 months to < 18 years of age at randomization; or reactive results in subjects < 8 months of age at randomization.|Up to 420 days (Visit 11) post-treatment|Subjects who have both testing missed are excluded in the Overall Number of Participants Analyzed and Number Analyzed in each arm.|||Participants|||Count of Participants
2563314|NCT02625974|Other Pre-specified|Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit (Part 1)|Using frequencies of matches and mismatches to assess agreement|Up to 420 days (Visit 11) post-treatment|Subjects who have testing missed are excluded in the Number Analyzed at each visit.|||Participants|||Count of Participants
2566425|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Serum Creatinine||Baseline, Week 24|Participants with measurements at given time point.|||µmol/L||Standard Deviation|Mean
2563317|NCT02625974|Other Pre-specified|Number of Subjects Cured With 60-day Regimen Compared With Historical Active Control (Benznidazole)|This exploratory efficacy analysis evaluated the cure rate assessed as seroconversion of nifurtimox after 1-year post-treatment follow-up with that of published data for benznidazole (Sosa Estani et al. 1998 and de Andrade et al. 1996) at 4- and 3-year post-treatment follow-up, respectively, used as historical control.|Up to 420 days (Visit 11) post-treatment||||Participants|||Count of Participants
2563318|NCT02625974|Secondary|Antibody Titer in Plasma Over Time in All Subjects (Part 2)|Measured once per year by recombinant ELISA and total purified antigen ELISA in subjects treated either with the 60- or 30-day nifurtimox treatment regimen.|Up to 4 years after end of treatment||2022-08-31|08/2022||||
2563319|NCT02625974|Secondary|Proportion of Responders With Seronegative Conversion and no Evidence of Cardiomyopathy (Part 2)|Seronegative conversion measured by two types of assays (recombinant ELISA and IHA). Cardiomyopathy as evaluated by electrocardiogram.|Up to 4 years after end of treatment||2022-08-31|08/2022||||
2563320|NCT02625974|Secondary|Incidence of Seronegative Conversion Received at Least One Dose of the 30-day Nifurtimox Treatment Regimen. (Part 2)|Measured once per year by two types of assays (recombinant ELISA and IHA) in subjects received at least one dose of 30-day nifurtimox treatment regimen.|Up to 4 years after end of treatment||2022-08-31|08/2022||||
2563321|NCT02625974|Secondary|Nifurtimox Concentration Over Time in Plasma at Visit 8 (Part 1)|Measured in sub-population.|At Visit 8 (Day 60): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours|"Blood samples for pharmacokinetic parameters ware optional and required consent/assent of the subject/subject’s legally authorized representative(s). A total of 59 subjects contributed blood samples for the analysis.~Number analyzed signifies subjects who were evaluable for the specified parameter at each time point, respectively."|||ug/L||Full Range|Median
2563322|NCT02625974|Secondary|Nifurtimox Concentration Over Time in Plasma at Visit 6 (Part 1)|Measured in sub-population.|At Visit 6 (Day 30): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours|"Blood samples for pharmacokinetic parameters ware optional and required consent/assent of the subject/subject’s legally authorized representative(s). A total of 59 subjects contributed blood samples for the analysis.~Number analyzed signifies subjects who were evaluable for the specified parameter at each time point, respectively."|||ug/L||Full Range|Median
2563323|NCT02625974|Secondary|Nifurtimox Concentration Over Time in Plasma at Visit 3 (Part 1)|Measured in sub-population.|At Visit 3 (Day 7): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours|"Blood samples for pharmacokinetic parameters ware optional and required consent/assent of the subject/subject’s legally authorized representative(s). A total of 62 subjects contributed blood samples for the analysis.~Number analyzed signifies subjects who were evaluable for the specified parameter at each time point, respectively."|||ug/L||Full Range|Median
2563324|NCT02625974|Secondary|Nifurtimox Concentration Over Time in Plasma at Visit 2 (Part 1)|Measured in sub-population.|At Visit 2 (Day 1): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours|"Blood samples for pharmacokinetic parameters ware optional and required consent/assent of the subject/subject’s legally authorized representative(s). A total of 63 subjects contributed blood samples for the analysis.~Number analyzed signifies subjects who were evaluable for the specified parameter at each time point, respectively."|||ug/L||Full Range|Median
2563325|NCT02625974|Secondary|Mean Changes in Vital Signs(Temperature) Between the Treatment Groups From Baseline (Part 1)|Temperature|Baseline and up to 420 days (Visit 11) post-treatment|Number analyzed signifies subjects who were evaluable for the specified parameter for each treatment regimen, respectively.|||°C||Standard Deviation|Mean
2563326|NCT02625974|Secondary|Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline (Part 1)|Heart Rate|Baseline and up to 420 days (Visit 11) post-treatment|Number analyzed signifies subjects who were evaluable for the specified parameter for each treatment regimen, respectively.|||BEATS/MIN||Standard Deviation|Mean
2563327|NCT02625974|Secondary|Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline (Part 1)|Respiratory Rate|Baseline and up to 420 days (Visit 11) post-treatment|Number analyzed signifies subjects who were evaluable for the specified parameter for each treatment regimen, respectively.|||BREATHS/MIN||Standard Deviation|Mean
2563328|NCT02625974|Secondary|Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline (Part 1)|Diastolic Blood Pressure|Baseline and up to 420 days (Visit 11) post-treatment|Number analyzed signifies subjects who were evaluable for the specified parameter for each treatment regimen, respectively.|||mmHg||Standard Deviation|Mean
2563329|NCT02625974|Secondary|Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline (Part 1)|Systolic Blood Pressure|Baseline and up to 420 days (Visit 11) post-treatment|Number analyzed signifies subjects who were evaluable for the specified parameter for each treatment regimen, respectively.|||mmHg||Standard Deviation|Mean
2563330|NCT02625974|Secondary|Number of Subjects With Abnormal ECG Findings Considered as Clinically Significant by Investigators (Part 1)|Clinical significance of abnormal ECG was based on the judgement of the investigator|Up to 420 days (Visit 11) post-treatment|FAS|||Participants|||Count of Participants
2563331|NCT02625974|Secondary|Number of Subjects With Abnormal Urinalysis Findings Considered as Clinically Significant or Reported as Adverse Events (AEs)|Urinalysis was performed and the following parameters evaluated: bilirubin, blood (red blood cells, white blood cells), chorionic gonadotropin β, glucose, ketones, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen.|Up to 420 days (Visit 11) post-treatment|FAS|||Participants|||Count of Participants
2563332|NCT02625974|Secondary|Number of Subjects With Treatment-emergent Low Coagulation Abnormalities by Treatment (Part 1)|"The number analyzed represents the number of subjects at baseline with a normal or higher than normal laboratory assessment who also had at least one valid laboratory value after start of treatment.~The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline."|Up to 420 days (Visit 11) post-treatment|Subjects with missing or low abnormal values at baseline are not included in the number analyzed.|||Participants|||Count of Participants
2563518|NCT02623803|Secondary|Pain With Coughing|Pain with coughing will be measured 30 minutes after arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.|30 minutes after arrival to PACU||||score on a scale||Standard Deviation|Mean
2563333|NCT02625974|Secondary|Number of Subjects With Treatment-emergent High Coagulation Abnormalities by Treatment (Part 1)|"The Number Analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment.~The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline."|Up to 420 days (Visit 11) post-treatment|Subjects with missing or high abnormal values at baseline are not included in the number analyzed.|||Participants|||Count of Participants
2563334|NCT02625974|Secondary|Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment (Part 1)|"The number analyzed represents the number of subjects at baseline with a normal or higher than normal laboratory assessment who also had at least one valid laboratory value after start of treatment.~The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline."|Up to 420 days (Visit 11) post-treatment|Subjects with missing or low abnormal values at baseline are not included in the number analyzed.|||Participants|||Count of Participants
2563335|NCT02625974|Secondary|Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment (Part 1)|"The number analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. Subjects with missing or high abnormal values at baseline are not included in the number analyzed.~The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline."|Up to 420 days (Visit 11) post-treatment|Subjects with missing or high abnormal values at baseline are not included in the number analyzed.|||Participants|||Count of Participants
2563336|NCT02625974|Secondary|Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment (Part 1)|"The number analyzed represents the number of subjects at baseline with a normal or higher than normal laboratory assessment who also had at least one valid laboratory value after start of treatment.~The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline."|Up to 420 days (Visit 11) post-treatment|Subjects with missing or low abnormal values at baseline are not included in the number analyzed.|||Participants|||Count of Participants
2563337|NCT02625974|Secondary|Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment (Part 1)|"The Number Analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment.~The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline."|Up to 420 days (Visit 11) post-treatment|Subjects with missing or high abnormal values at baseline are not included in the number analyzed.|||Participants|||Count of Participants
2563338|NCT02625974|Secondary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|TEAEs comprised events which first occurred or worsened at or after first application of study drug during the course of the study up to and including 7 days after last application of study drug|Up to 420 days (Visit 11) post-treatment|FAS|||Participants|||Count of Participants
2563339|NCT02625974|Secondary|Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results|The qPCR is molecular technique, considered a tool to diagnose acute and congenital Chagas disease, as well as a marker to measure treatment failure when demonstrating positive (detectable) results|Up to 420 days (Visit 11) post-treatment|FAS|||Participants|||Count of Participants
2563340|NCT02625974|Secondary|Number of Subjects With a Positive Serological Response Using Non-conventional Enzyme-linked Immunosorbent Assay-F29 (ELISAF29) Test|The non-conventional ELISA-F29 test is considered an early marker of treatment efficacy in chronic Chagas disease.|Up to 420 days (Visit 11) post-treatment|FAS|||Participants|||Count of Participants
2563341|NCT02625974|Secondary|Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age)||Up to 90 days (Visit 9) post-treatment|Subjects from FAS who were below 8 months of age at randomization|||Participants|||Count of Participants
2563342|NCT02625974|Secondary|Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 11|The evaluation was based on clinical examinations.|Up to 420 days (Visit 11) post-treatment|Number of participants available at each visit.|||Participants|||Count of Participants
2563343|NCT02625974|Secondary|Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 10|The evaluation was based on clinical examinations.|Up to 240 days (Visit 10) post treatment|Number of participants available at each visit.|||Participants|||Count of Participants
2563344|NCT02625974|Secondary|Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 9|The evaluation was based on clinical examinations.|Up to 90 days (Visit 9) post treatment|Number of participants available at each visit.|||Participants|||Count of Participants
2563345|NCT02625974|Secondary|Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 8|The evaluation was based on clinical examinations.|Up to 60 days (Visit 8) end of treatment|Number of participants available at each visit.|||Participants|||Count of Participants
2563346|NCT02625974|Secondary|Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 6|The evaluation was based on clinical examinations.|Up to 30 days (Visit 6)|Number of participants available at each visit.|||Participants|||Count of Participants
2563347|NCT02625974|Secondary|Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 3|The evaluation was based on clinical examinations.|Up to 7 days (Visit 3)|Number of participants available at each visit|||Participants|||Count of Participants
2563348|NCT02625974|Secondary|Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 1|The evaluation was based on clinical examinations.|At Visit 1 (before treatment started)|FAS|||Participants|||Count of Participants
2563349|NCT02625974|Primary|Incidence Rate of Seronegative Conversion for Subjects Received at Least One Dose of the 60-day Nifurtimox Treatment Regimen.(Part 2)|Seronegative conversion measured by two types of assay (recombinant ELISA and indirect hemagglutination assay [IHA]) in subjects who were randomized and received at least one dose of the 60-day nifurtimox treatment regimen.|Up to 4 years after end of treatment||2022-08-31|08/2022||||
2563350|NCT02625974|Primary|Percentage of Participants Cured|"Cure is defined as sero-reduction (in subjects ≥8 months to <18 years of age at randomization) or sero-conversion (in all subjects). Sero-reduction is defined as a ≥20% reduction in optical density [OD]) measured by two conventional ELISA serology tests and sero-conversion is defined as negative Immunoglobulin G (IgG) concentration measured by two conventional ELISA serology tests.~Subjects who have missing conventional serology results at the 12 month time point were treated as failures (ie, no cure).~For the primary objective in the study, superiority over placebo was confirmed if the lower limit of the 95% Confidence Interval (CI) for the nifurtimox (60-day regimen) cure rate is greater than 16%, the larger of the upper limits of the 95% CIs from the two publications."|At 12 months post-treatment|Full Analysis Set (FAS). The primary analyses of efficacy, safety, and background data were performed using the full analysis set (FAS). The FAS was defined as subjects who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2563351|NCT02625922|Secondary|Log-transformed Concentration Values of Heart-type Fatty Acid-binding Protein (H-FABP) Concentrations Compared to Placebo|This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.|Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1)|The full analysis set (FAS) consisted of all randomized patients. Patients were analyzed according to the treatment they had been assigned to at randomization.|||ng/mL||Standard Deviation|Mean
2563352|NCT02625922|Secondary|Log-transformed Concentration of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations Compared to Placebo|This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.|Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15 +/- 1)|The full analysis set (FAS) consisted of all randomized patients.|||pg/mL||Standard Deviation|Mean
2563353|NCT02625922|Secondary|Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentrations After Exercise Compared to Placebo at 4 and 5 Hours|This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.|4 and 5 hours after exercise testing session|The objective was not analyzed because the validation of the hs-cTnI Singulex Erenna® assay was not completed because of the early termination of the study.||||||
2563354|NCT02625922|Primary|Geometric Mean of High Sensitivity Cardiac Troponin I (Hs-cTnI) Concentration After Exercise Compared to Placebo|This cardiac biomarker measurement was obtained to determine plasma concentrations following a cardiac stress test.|Baseline, up to 7 hours after the start of an exercise testing session on treatment period 1 (Day 1) and treatment period 2 (Day 15+/- 1)|The primary analysis of mixed model repeated measures was not performed because the validation of the primary endpoint variable hs-cTnI assay (Singulex Erenna®) was not completed because of the early termination of the study and, therefore, hs-cTnI was not analyzed.||||||
2563355|NCT02625844|Primary|Average Observed Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents (ESAs)|Health care personnel time (hours/year) includes preparation, distribution and administration of Erythropoiesis Stimulating Agents (ESAs)|Up to 3 months||||hours/year|||Number
2563356|NCT02625623|Secondary|Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Stomach Cancer Specific (EORTC QLQ-STO22) Questionnaire Scores at EOT|The EORTC QLQ-STO22 supplements the EORTC QLQ-C30 to assess symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms.|Baseline, EOT (up to Week 66)|"HRQoL analysis set included a subset of the FAS and included FAS participants who met the following criteria: had 1 Baseline HRQoL assessment and had at least 1 post-Baseline HRQoL questionnaire completed. Number of Participants Analyzed signifies the number of participants analyzed in this outcome."|||units on a scale||Standard Deviation|Mean
2563357|NCT02625623|Secondary|Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status Scale Score at EOT|EORTC QLQ-C30 is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnoea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 GHS/QoL score ranges from 0 to 100; High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.|Baseline, EOT (up to Week 66)|HRQoL analysis set included a subset of the FAS and included FAS participants who met the following criteria: had 1 Baseline HRQoL assessment and had at least 1 post-Baseline HRQoL questionnaire completed. “Number of Participants Analyzed” signifies the number of participants analyzed in this outcome.|||units on a scale||Standard Deviation|Mean
2563358|NCT02625623|Secondary|Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Visual Analogue Scale (VAS) at EOT|EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.|Baseline, EOT (up to Week 66)|HRQoL analysis set included a subset of the FAS and included FAS participants who met the following criteria: had 1 Baseline HRQoL assessment, had at least 1 post-Baseline HRQoL questionnaire completed. “Number of Participants Analyzed” signifies the number of participants analyzed in this outcome.|||millimeter (mm)||Standard Deviation|Mean
2563475|NCT02624492|Primary|The MTD of BI 836826 With GemOx- Phase 1b|MTD defined as the highest dose studied for which the number of patients with dose-limiting toxicity (DLT) was 17% or less (i.e. not more than 1 of 6 patients) during the MTD evaluation period (Cycle 1).|14 days from first trial medication|The trial was discontinued prematurely before the MTD based on the frequency of patients with DLTs in the MTD evaluation period, i.e. the 1st treatment cycle, was reached.||||||
2563359|NCT02625623|Secondary|Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score at End of Treatment (EOT)|EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall composite health state index score, with scores ranging from -0.594 to 1. A higher score indicates better health state.|Baseline, EOT (up to Week 66)|Health-related quality of life (HRQoL) analysis set included a subset of the FAS and included FAS participants who met the following criteria: had 1 Baseline HRQoL assessment, had at least 1 post-Baseline HRQoL questionnaire completed. “Number of Participants Analyzed” signifies the number of participants analyzed in this outcome.|||units on a scale||Standard Deviation|Mean
2563360|NCT02625623|Secondary|Objective Response Rate (ORR)|The ORR defined as the percentage of all randomized participants with a confirmed BOR of PR or CR according to RECIST v1.1 and as adjudicated by the IRC.|From randomization up to data cutoff (assessed up to 627 days)|FAS included all participants who were randomized to study treatment.|||percentage of participants||95% Confidence Interval|Number
2563361|NCT02625623|Secondary|Best Overall Response (BOR)|BOR determined by RECIST 1.1 and defined as best-confirmed response of any of following: complete response (CR), partial response (PR), stable disease (SD) and PD recorded from date of randomization until disease progression or recurrence. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in SLD of all lesions. SD=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions. PR or CR confirmed at a subsequent tumor assessment, not sooner than 5 weeks after initial documentation or at an assessment later than the next assessment after the initial documentation of PR or CR. SD confirmed at least 6 weeks after randomization. Confirmed PD = progression <= 12 weeks after date of randomization (and not qualifying for CR, PR or SD).|From randomization up to data cutoff (assessed up to 627 days)|FAS included all participants who were randomized to study treatment.|||Participants|||Count of Participants
2563362|NCT02625623|Secondary|Progression Free Survival (PFS)|The PFS time was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause (whichever occurs first). PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates.|From randomization up to data cutoff (assessed up to 627 days)|FAS included all participants who were randomized to study treatment.|||months||95% Confidence Interval|Median
2563363|NCT02625623|Primary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death due to any cause. For participants who were still alive at the time of data analysis or who were lost to follow-up, OS time was censored at the date of last contact. OS was measured using Kaplan-Meier (KM) estimates.|From randomization up to data cutoff (assessed up to 627 days)|FAS included all participants who were randomized to study treatment.|||months||95% Confidence Interval|Median
2563364|NCT02625571|Secondary|Child Sexual Concerns on the Trauma Symptom Checklist for Young Children (TSCYC)|The sexual concerns subscale on the TSCYC provides another metric of sexual behaviors of children. Scaore are reported in T-score, which have a mean of 50 and a standard deviation of 10. A score of 65-70 typically indicates a borderline or sub-syndromal level of concern, while a score of 70 or above indicates clinically significant concern. As such, a higher score indicates greater concern. While there is technically no limit for calculating minimum and maximum values, the reported range of scores is typically between 40 and 100.|4-6 months||||Score on a scale||Standard Deviation|Mean
2563365|NCT02625571|Primary|Child Sexual Behavior on the Child Sexual Behavior Inventory (CSBI)|Total raw score of the CSBI (potential range = 0-138). Higher scores indicate a greater number and frequency of reported problematic sexual behavior.|4-6 months||||Scores on a scale||Standard Deviation|Mean
2563366|NCT02625545|Secondary|Intent to Treat Population Post Void Residual Change From Baseline to 12 Month Follow-up|Post Residual Void (PVR) is the amount of urine left in the bladder after using the restroom. PVR is determined using ultrasound or bladder scanner.|12 Months|44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.|||percent change||95% Confidence Interval|Mean
2563367|NCT02625545|Secondary|Intent to Treat Population Post Void Residual Measurement at Baseline and 12 Month Follow-up|Post Residual Void (PVR) is the amount of urine left in the bladder after using the restroom. PVR is determined using ultrasound or bladder scanner.|12 Months|44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.|||mL||Standard Deviation|Mean
2563368|NCT02625545|Secondary|Intent to Treat Population Peak Flow Rate Percent Change From Baseline to 12 Month Follow-up|Peak or maximum flow rate [ml/sec] was collected using uroflowmetry, a standard diagnostic used to test to assess how well the urinary tract functions. A lower number indicates a reduced flow rate.|12 Months|37/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit. Includes only cases where voided volume is at least 125ml.|||percent change||95% Confidence Interval|Mean
2563369|NCT02625545|Secondary|Intent to Treat Population Peak Flow Rate Scores at Baseline and 12 Month Follow-up|Peak or maximum flow rate [ml/sec] was collected using uroflowmetry, a standard diagnostic used to test to assess how well the urinary tract functions. A lower number indicates a reduced flow rate.|12 Months|37/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit. Includes only cases where voided volume is at least 125ml.|||mL/sec||Standard Deviation|Mean
2563370|NCT02625545|Secondary|Intent to Treat Population BPHII Score Percent Change From Baseline to 12 Month Follow-up|Present change in Intent to Treat population, Benign Prostatic Hyperplasia Impact Index (BPHII) score from Baseline to 12 Month Follow-up|12 Months|44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.|||percent change||95% Confidence Interval|Mean
2563493|NCT02624050|Secondary|Number of Participants With Refractory Hypotension|Refractory hypotension is defined as a hypotensive event that continues after 3 doses of vasopressors|Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction||||Participants|||Count of Participants
2563371|NCT02625545|Secondary|Intent to Treat Population BPHII Scores at Baseline and 12 Month Follow-up|BPHII (Benign Prostatic Hyperplasia Impact Index) is used to assess the impact of BPH symptoms on subject health and functioning. The BPHII is a self-administered questionnaire with 4 questions about urinary problems during the past month regarding physical discomfort, worry about health, how bothersome symptoms are, and whether the symptoms are interfering with doing usual activities. Scores for each question range from 0 to 4, with higher score indicating greater impact. Maximum score is 16.|12 Months|44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.|||BPHII score||Standard Deviation|Mean
2563372|NCT02625545|Secondary|Intent to Treat Population Quality of Life Score Perfect Change From Baseline to 12 Month Follow-up|Quality of Life (QOL) score results from a disease-specific (BPH) quality of life question (bother score) scored on a scale from 0 to 6 points (delighted to terrible).|12 Months|44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.|||percent change||95% Confidence Interval|Mean
2563373|NCT02625545|Secondary|Intent to Treat Population Quality of Life Scores at Baseline and 12 Month Follow-up|Quality of Life (QOL) score results from a disease-specific (BPH) quality of life question (bother score) scored on a scale from 0 to 6 points (delighted to terrible).|12 Months|44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.|||score on a scale||Standard Deviation|Mean
2563374|NCT02625545|Secondary|Intent to Treat Population International Prostate Symptom Score Percent Change From Baseline to 12 Month Follow-up|Present change in Intent to Treat population International Prostate Symptom Score (IPSS) from Baseline to 12 Month Follow-up|12 Months|44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow-up visit.|||percent change||95% Confidence Interval|Mean
2563375|NCT02625545|Secondary|Intent to Treat Population International Prostate Symptom Scores at Baseline and 12 Month Follow-up|The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic.|12 Months|44/45, 1 Subject was retreated with additional UroLift System devices prior to the 12 month Follow up visit.|||Score on a scale||Standard Deviation|Mean
2563376|NCT02625545|Primary|At 6 Months, the 95% Lower Confidence Limit of the Mean Percent Improvement in IPSS Over Baseline for the UroLift System Must be ≥ 25%.|The International Prostate Symptom Score (IPSS) is a standardized 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). The symptoms must have been experienced in the last month and each answer is scored from 0 to 5 for a maximum score of 35 points.Those patients scoring 7 or below are generally considered mildly symptomatic, whereas 20 or above is considered severely symptomatic.|6 months|Intent to treat Population|||percent change||95% Confidence Interval|Mean
2563377|NCT02625428|Secondary|Number of Patients With a Higher Degree of Renal Transplant Rejection Using Multiple Biopsies Compared to a Single Biopsy.||1 year|This outcome measure was not evaluated or analyzed as all subjects received multiple biopsies||||||
2563378|NCT02625428|Primary|Abnormal Biopsy|Number of subjects with abnormal biopsies in either the primary or secondary biopsy location, by diagnosis from a clinical pathologist|1 year||||Participants|||Count of Participants
2563379|NCT02625402|Secondary|Percentage of Participants With a Clear Treatment Preference|1 item assessing patient's treatment preference (surgery, non-surgical options, or not sure). The percentage who have a clear preference (either for surgery or non surgical options) will be calculated.|In clinic, immediately before the first visit with surgeon||||Participants|||Count of Participants
2563380|NCT02625402|Secondary|Percentage of Participants Who Used the Decision Aid|1 item asking patients how much they reviewed the program (none, some. most, all). The percentage who report viewing most or all will be calculated.|In clinic, immediately before the first visit with surgeon|We wanted to assess how much patients reviewed whichever decision aid they were randomized to before their visit. As such, we assessed how much they reviewed of the program (none, some, most, all) and will share the categorical results.|||Participants|||Count of Participants
2563381|NCT02625402|Primary|Hip and Knee Decision Quality Instruments Knowledge Subscale Scores|5 multiple choice knowledge items from the Hip and Knee Decision Quality Instruments will be averaged into a knowledge subscale score (0-100%) with higher scores indicating higher knowledge.|In clinic, immediately before the first visit with surgeon|The total knowledge score of 5 multiple questions with a total score of 0-100% was generated for all study patients.|||units on a scale||Standard Deviation|Mean
2563382|NCT02625324|Secondary|Safety and Effectiveness Outcome|Safety and Effectiveness outcome measures between implant procedure and 60 months. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort. Measures include: aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, stent graft migration compared to 1 month imaging, aneurysm expansion greater than 5 mm compared to 1 month imaging, and endoleaks.|60 Month||2023-12-31|12/2023||||
2563383|NCT02625324|Secondary|Safety and Effectiveness Outcome|"Safety and effectiveness outcome measure between implant procedure and 48 months. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.~Measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month."|48 month||2022-12-31|12/2022||||
2563494|NCT02624050|Primary|Number of Participants Who Had Hypotensive Events|Hypotensive events under either methohexital or propofol general anesthesia will be counted as the primary outcome measure|Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction||||Participants|||Count of Participants
2566426|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: LDL||Baseline, Week 48|Participants with measurements at given time point.|||mmol/L||Standard Deviation|Mean
2563384|NCT02625324|Secondary|Safety and Effectiveness Outcome|"Safety outcome measures between 0-1095 days and Effectiveness outcome measures between 731-1095 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.~Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month."|36 Month||2021-12-31|12/2021||||
2563385|NCT02625324|Secondary|Safety and Effectiveness Outcome|"Safety outcome measures between 0-730 days and Effectiveness outcome measures between 366-730 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.~Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month."|24 Month||2020-12-31|12/2020||||
2563386|NCT02625324|Secondary|Safety and Effectiveness Outcome|"Safety outcome measures between 0-365 days and Effectiveness outcome measures between 184-365 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.~Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month."|12 Month|Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).|||Participants|||Count of Participants
2563387|NCT02625324|Secondary|Safety and Effectiveness Outcome|"Safety outcome measures between 0-183 days and Effectiveness outcome measures between 31-183 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.~Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month."|6 Month|"Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International Trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US).~Note that 6-month follow up is not mandatory for subjects enrolled under the Valiant Evo International protocol, resulting in fewer subjects analyzed at 6 months."|||Participants|||Count of Participants
2563388|NCT02625324|Secondary|Safety and Effectiveness Outcome|"Safety and Effectiveness outcome measures between 0-30 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US [OUS]).~Measures include: peri-operative mortality, adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, and endoleaks."|30 Days|Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).|||Participants|||Count of Participants
2563389|NCT02625324|Primary|Composite Safety and Effectiveness Endpoint That is Based on the Percentage of Subjects Who Experienced (a) Access and/or Deployment Failures; and/or (b) Major Device Effect (MDE) Within 30 Days Post Index Procedure|"MDEs include: device-related secondary procedures, device-related mortality, conversion to open surgery, thoracic aortic aneurysm rupture.~Access failure: Inability to insert device due to mechanical failure or anatomic exclusions of the femoral or iliac arteries.~Deployment failure: Deployment failure due to subject anatomy or mechanical failure. Specifically, deployment of the stent graft from the delivery system.~Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects. The poolability on the primary endpoint between US and OUS data were assessed using Fisher's exact test."|30 Days|The 30-day primary endpoint was evaluated for PMA approval when 87 subjects completed 30 day follow-up.|||Participants|||Count of Participants
2563390|NCT02625298|Secondary|Presence of Clinical Symptoms|Clinical examination will be used to assess the presence of spontaneous or provoked pain, discomfort during chewing, numbness or tenderness to percussion and/or palpation, altered tooth mobility, tooth crown discoloration or abscess and/or sinus tract.|baseline||||participants|||Number
2563391|NCT02625298|Primary|Changes Between Initial and Post Treatment Dimensions of Periapical Lesions|Changes in the dimensions of periapical lesions will be performed according to the analysis of initial and post treatment radiographs (baseline, 3, 6, 12, and 24-months subsequent to obturation) after being photographed using a digital camera Kodak EasyShare Max (Z990) with millimetre measurer in order to obtain interpretation of sizes of periapical lesions during conversion of pixels in mm2 by digital data processing in Adobe Photoshop CS software. Sucessful radiographic assessment will include decrease in size of the periapical lesion at the recall time of 24 months.|baseline, 3, 6, 12 and 24 months||||square millimeters|tooth|Standard Deviation|Mean
2563392|NCT02625259|Secondary|Part 1: Renal Clearance (CLr) of TAK-117||Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose|The PK-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.|||liter per hour (L/hr)||Standard Deviation|Mean
2563393|NCT02625259|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-117||Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose|The PK-evaluable population where data at specified time points were available. The PK-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2563394|NCT02625259|Primary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-117||Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose|The PK-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2563395|NCT02625259|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117||Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose|The PK-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.|||hours||Full Range|Median
2563396|NCT02625259|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-117||Part 1 and 2: Day 1 or 15 pre-dose and at multiple time points (up to 72 hours) post-dose; Part 3: Day 1 (TAK-117) and Day 15 (TAK-117 + Lansoprazole) pre-dose and at multiple time points (up to 72 hours) post-dose|The pharmacokinetic (PK)-evaluable population included participants who received both doses of TAK-117 study drug in each sequence and had sufficient PK data to reliably estimate PK parameters that were used for PK analyses.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2563397|NCT02625233|Primary|Visual Acuity (logMAR)|The visual acuity (LogMAR) was collected at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The average Visual Acuity (logMAR) across the 4 study visits and at each individual visit was reported for each lens.|Up to 6 Month Follow-up|Subjects that completed all study visits.|||LogMAR|Subject Eyes|Standard Deviation|Mean
2563398|NCT02625233|Primary|Proportion of Eyes Grade 3 or Higher SLF|Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The proportion of subject eyes with SLF grade 3 or higher was reported for each lens.|Up to 6 Month Follow-up|Subjects that were dispensed a study lens.|||Proporiton of Subject Eyes|Subject Eyes||Number
2563399|NCT02625220|Primary|Proportion of Subject Eyes With Acceptable Lens Fit|Acceptability of contact lens fit was assessed via slit lamp and was reported as a binary response as Acceptable or Unacceptable. The proportion of eyes with acceptable fit was reported.|15 Minute Post Insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.|||proportion of Subject Eyes|Subject Eyes||Number
2563400|NCT02625220|Primary|Proportion of Subjects Eyes With Lens Stability With Blink Within 5 Degrees|Lens stability with blink was measured using a slit lamp. The rotational stability of the lens during a series of normal (unforced) blinks was measured for both eyes. The data was dichotomized as 'response=1' if the lens stability was less than or equal to 5 degrees or 'response=0' otherwise. The proportion of eyes with rotational stability of 5 degrees or lower was reported.|15 Minutes Post Insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.|||proportion of Subject Eyes|Subject Eyes||Number
2563401|NCT02625220|Primary|The Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees|Absolute rotation was measured using a slit lamp. Absolute rotation measured at 15-minute post insertion was categorized into a binary outcome as 'response=1' if the absolute rotation is less than or equal to 10 degrees or 'response=0' otherwise. The proportion of eyes with absolute rotation less than or equal to 10 degrees was reported.|15 Minutes Post Insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.|||proportion of Subject Eyes|Subject Eyes||Number
2563402|NCT02625220|Primary|Proportion of Eyes With Monocular Visual Acuity Better Than 20/40|Monocular visual acuity was assessed using distance Snellen visual acuity. Visual Acuity data was dichotomized such that 'response=1' if a subjects has 20/40 or better and 'response=0' if subject has worse than 20/40. The proportion of eyes with 20/40 or better was reported.|7 day follow-up|The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subject was excluded from the analysis population due to a major protocol deviation.|||proportion of Subject Eyes|Subject Eyes||Number
2563403|NCT02625207|Secondary|Part 2: Number of Participants With Laboratory Abnormalities|Criteria: Hemoglobin; hematocrit; red blood cell count: <0.8*LLN, mean corpuscular volume; mean corpuscular hemoglobin concentration; mean platelet volume: <0.9*LLN or >1.1*ULN, platelet: <0.5*LLN or >1.75*ULN, white blood cells <0.6*LLN or >1.5*ULN, lymphocyte; neutrophil: <0.8*LLN or >1.2*ULN, basophil; eosinophil; monocyte: >1.2*ULN, bilirubin (total, direct, indirect) >1.5*ULN, aspartate aminotransferase; alanine aminotransferase; alkaline phosphatase: >3.0*ULN, total protein; albumin: <0.8*LLN or >1.2*ULN; creatinine: >1.3*ULN, uric acid >1.2*ULN, sodium<0.95*LLN or >1.05*ULN, potassium; chloride; calcium; bicarbonate:<0.9*LLN or >1.1*ULN, glucose <0.6*LLN or >1.5*ULN, urine specific gravity <1.003, urine pH <4.5 or >8, urine glucose or ketones (qualitative) >=1, urine protein; urine blood/hemoglobin >=1, urobilinogen; bilirubin; nitrite; leukocyte esterase >=1.|Baseline up to Day 11|Safety analysis set included all participants who received at least 1 dose of study drug. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.|||participants|||Number
2563414|NCT02625207|Secondary|Part 1: Average Plasma Concentration (Cav) of Metabolites of Maraviroc|Cavg is the average plasma concentration of metabolites of maraviroc during the 0 to 12 hour time period. It was calculated as area under the plasma concentration-time curve from 0 to 12 hours (AUC [0-12]) divided by 12. Metabolites of maraviroc included PF-6857639, PF-6857640, PF-06927572 and PF-06927573.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563404|NCT02625207|Secondary|Part 1: Number of Participants With Laboratory Abnormalities|Criteria: Hemoglobin; hematocrit; red blood cell count: <0.8*lower limit of normal, (LLN), mean corpuscular volume; mean corpuscular hemoglobin concentration; mean platelet volume:<0.9*LLN or >1.1* upper limit of normal (ULN), platelet: <0.5*LLN or >1.75*ULN, white blood cells <0.6*LLN or >1.5*ULN, lymphocyte; neutrophil: <0.8*LLN or >1.2*ULN, basophil; eosinophil; monocyte:>1.2*ULN, bilirubin (total, direct, indirect) >1.5*ULN, aspartate aminotransferase; alanine aminotransferase; alkaline phosphatase:>3.0*ULN, total protein; albumin:<0.8*LLN or >1.2*ULN; creatinine: >1.3*ULN, uric acid>1.2*ULN, sodium<0.95*LLN or >1.05*ULN, potassium; chloride; calcium; bicarbonate:<0.9*LLN or >1.1*ULN, glucose <0.6*LLN or >1.5*ULN, urine specific gravity <1.003, urine pH <4.5 or >8, urine glucose or ketones (qualitative) >=1, urine protein; urine blood/hemoglobin >=1, urobilinogen; bilirubin; nitrite; leukocyte esterase >=1.|Baseline up to Day 6|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2563405|NCT02625207|Secondary|Part 2: Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities|Criteria for ECG abnormalities: Maximum PR interval of >=300 msec, maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia's correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum increase of >=25 percent for baseline values of >200 msec and >=50 percent for baseline values of <=200 msec for PR interval, maximum increase from baseline of >=50 percent for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia's Correction).|Baseline up to Day 11|Safety analysis set included all participants who received at least 1 dose of study drug. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.|||participants|||Number
2563406|NCT02625207|Secondary|Part 1: Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities|Criteria for ECG abnormalities: Maximum PR interval of >=300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia's correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum increase of >=25 percent for baseline values of >200 msec and >=50 percent for baseline values of less than or equal to (<=) 200 msec for PR interval, maximum increase from baseline of >=50 percent for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia's Correction).|Baseline up to Day 6|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2563407|NCT02625207|Secondary|Part 2: Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for clinically significant vital sign abnormalities included supine/sitting pulse rate of <40 bpm or >120 bpm, standing pulse rate of <40 bpm or >140 bpm, supine SBP and standing SBP of <90 mm Hg, >=30 mm Hg, supine DBP and standing DBP of <50 mm Hg, >=20 mm Hg.|Baseline up to Day 11|Safety analysis set included all participants who received at least 1 dose of study drug. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.|||participants|||Number
2563408|NCT02625207|Secondary|Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for clinically significant vital sign abnormalities included supine/sitting pulse rate of less than (<) 40 beats per minute (bpm) or greater than (>)120 bpm, standing pulse rate of <40 bpm or >140 bpm, supine systolic blood pressure (SBP) and standing SBP of <90 millimeter of mercury (mm Hg), greater than or equal to (>=) 30 mm Hg, supine diastolic blood pressure (DBP) and standing DBP of <50 mm Hg, >=20 mm Hg.|Baseline up to Day 6|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2563409|NCT02625207|Secondary|Part 2: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 11 days that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to end of study (up to 11 days)|Safety analysis set included all participants who received at least 1 dose of study drug. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.|||participants|||Number
2563410|NCT02625207|Secondary|Part 1: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 days that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to end of study (up to 6 days)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2563411|NCT02625207|Secondary|Part 1: Plasma Concentration of Metabolites of Maraviroc at 12 Hour Post-dose|Metabolites of maraviroc included PF-6857639, PF-6857640, PF-06927572 and PF-06927573.|12 hour post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563412|NCT02625207|Secondary|Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Metabolites of Maraviroc|Metabolites of maraviroc included PF-6857639, PF-6857640, PF-06927572 and PF-06927573.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||hour||Full Range|Median
2563413|NCT02625207|Secondary|Part 1: Maximum Observed Plasma Concentration (Cmax) of Metabolites of Maraviroc|Metabolites of maraviroc included PF-6857639, PF-6857640, PF-06927572 and PF-06927573.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563495|NCT02623959|Other Pre-specified|Assessment of Symptom Burden, Pleurodesis Efficacy, Complications, Health Care Resource Utilization, the Need of Hospitalization for Pain Control, Pain Free Days and Mortality||baseline and 1 month|Due to slow accrual and the design of the study the protocol was terminated and no analysis was done.||||||
2563415|NCT02625207|Secondary|Part 1: Area Under The Plasma Concentration-Time Curve From Time 0 to 12 Hours (AUC [0-12]) of Metabolites of Maraviroc|AUC (0-12) is the area under the plasma concentration versus time curve from time zero (pre-dose) to 12 hours post-dose. Metabolites of maraviroc included PF-6857639, PF-6857640, PF-06927572 and PF-06927573.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2563416|NCT02625207|Secondary|Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Maraviroc||Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.|||hour||Full Range|Median
2563417|NCT02625207|Secondary|Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Maraviroc||Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||hour||Full Range|Median
2563418|NCT02625207|Secondary|Part 2: Plasma Concentration of Maraviroc at 24 Hours Post-dose||24 hours post-dose on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563419|NCT02625207|Secondary|Part 1: Plasma Concentration of Maraviroc at 12 Hours Post-dose||12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563420|NCT02625207|Secondary|Part 2: Maximum Observed Plasma Concentration (Cmax) of Maraviroc||Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563421|NCT02625207|Secondary|Part 1: Maximum Observed Plasma Concentration (Cmax) of Maraviroc||Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563422|NCT02625207|Secondary|Part 2: Average Plasma Concentration (Cavg) of Maraviroc|Cavg is the average plasma concentration of maraviroc during the 0 to 24 hour time period. It was calculated as area under the plasma concentration-time curve from 0 to 24 hours (AUC [0-24]) divided by 24.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563423|NCT02625207|Secondary|Part 1: Average Plasma Concentration (Cavg) of Maraviroc|Cavg is the average plasma concentration of maraviroc during the 0 to 12 hour time period. It was calculated as area under the plasma concentration-time curve from 0 to 12 hours (AUC [0-12]) divided by 12.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2563424|NCT02625207|Primary|Part 1: Metabolite to Parent Ratio for Area Under the Concentration-Time Curve From Time 0 to 12 Hours for Maraviroc and Its Metabolites (MRAUC12)|MRAUC12 is the ratio of AUC12 of maraviroc to AUC12 of maraviroc's metabolites. Metabolites of Maraviroc included PF-6857639, PF-6857640, PF-06927572 and PF-06927573. AUC12 is the area under the plasma concentration-time profile from time 0 to 12 hours post-dose.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2563425|NCT02625207|Primary|Part 2: Area Under The Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC [0-24]) of Maraviroc|AUC (0-24) is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest. Data for Part 2 was planned to be analyzed only in Cohorts 1 and 3, as pre specified in protocol.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2563426|NCT02625207|Primary|Part 1: Area Under The Plasma Concentration-Time Curve From Time 0 to 12 Hours (AUC [0-12]) of Maraviroc|AUC (0-12) is the area under the plasma concentration versus time curve from time zero (pre-dose) to 12 hours post-dose.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12 hours post-dose on Day 5|Pharmacokinetic (PK) parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of primary interest.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2563427|NCT02625181|Secondary|Time to Discharge From the Postanesthesia Care Unit (PACU)|This is the number of minutes from admission to the PACU until discharge, assessed up to 2 days|A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU||||minutes||Standard Deviation|Mean
2563428|NCT02625181|Secondary|The Number of Prophylactic Interventions for PONV|the absolute number of prophylactic interventions applied between the admission of the patient in the holding room until admission to the PACU.|A specific time frame on the day of surgery: from the start of admission at the holding room to the end of the anesthetic case||||prophylactic antiemetics administered||Standard Deviation|Mean
2563429|NCT02625181|Secondary|PONV Incidence: Number of Participants With Postoperative Nausea and Vomiting|The occurrence of PONV, as defined by the administration of antiemetics in the PACU between admission to PACU and discharge from PACU.|PACU recovery period||||Participants|||Count of Participants
2563430|NCT02625181|Primary|Adherence to PONV Guidelines|PONV guideline adherence: percentage of patients who received the exact number of prophylactic interventions for PONV that were recommended by the decision support.|A specific time frame on the day of surgery: the start of admission at the holding room to the end of the anesthetic case||||Participants|||Count of Participants
2563431|NCT02624986|Secondary|Blood Chemistry Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline|Clinical laboratory tests for blood chemistry parameters were performed at local laboratories; any abnormal values (High or Low) were based on local laboratory normal ranges. Laboratory abnormalities are presented by the highest (worst) severity grade (according to NCI-CTCAE v4.0) at baseline to the highest grade post-baseline. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a medical intervention or a change in concomitant therapy. For a patient with multiple post-baseline abnormalities, the highest (worst) grade for a given lab test is reported. BL = Baseline; Blood Gluc., Fast. = blood glucose, fasting; SGOT/AST = serum glutamic-oxaloacetic transaminase/aspartate transaminase; SGPT/ALT = serum glutamic-pyruvic transaminase/alanine transaminase; Triacylglyc. Lipase = triacylglycerol lipase|From Baseline until 35 days after the last dose of study drug (up to 29 months)|Safety Population: participants who received at least one dose of any component of the combination treatment.|||Participants|||Count of Participants
2563432|NCT02624986|Secondary|Hematology Laboratory Test Results Shift Table: Number of Participants by Highest NCI-CTCAE v4.0 Grade at Baseline to Highest Grade Post-Baseline|Clinical laboratory tests for hematology parameters were performed at local laboratories; any abnormal values (High or Low) were based on local laboratory normal ranges. Laboratory abnormalities are presented by the highest (worst) severity grade (according to NCI-CTCAE v4.0) at baseline to the highest grade post-baseline. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a medical intervention or a change in concomitant therapy. For a patient with multiple post-baseline abnormalities, the highest (worst) grade for a given lab test is reported. Abs. = absolute count; BL = baseline; WBC = white blood cell count|From Baseline until 35 days after the last dose of study drug (up to 29 months)|Safety Population: participants who received at least one dose of any component of the combination treatment.|||Participants|||Count of Participants
2563433|NCT02624986|Secondary|Number of Participants by Electrocardiogram (ECG) Results Assessment Shift From Baseline to Specified Post-Baseline Timepoints|"Single, resting, 12-lead ECG recordings were to be obtained after the participant had been resting in a supine position for at least 10 minutes. Any morphologic waveform changes or other ECG abnormalities were to be documented and clinical significance was determined based on the presence of symptoms, per the investigator's judgment. If the ECG assessment was missing at baseline then it was recorded as Missing. The ECG results assessments are presented as the shift from baseline to post-baseline assessments at each timepoint. BL = baseline; Cyc1, D1 = Induction Cycle 1 Day 1; Cyc4, D1 = Induction Cycle 4 Day 1; CS = Clinically Significant; EOI = End of Induction Treatment - Completion/Discontinuation; EOM = End of Maintenance Treatment - Completion/Discontinuation; MM1 = Maintenance Month 1; Unsched = Unscheduled Visit"|Baseline, Induction Cycle 1 Day 1 and Cycle 4 Day 1, End of Induction (up to 6 cycles; 1 cycle is 28 days); Every 2 months during maintenance treatment from Months 1-23; End of Maintenance (up to 24 months); Unscheduled Visits (as clinically indicated)|Safety Population: participants who received at least one dose of any component of the combination treatment. The number analyzed includes participants who were evaluable at each timepoint.|||Participants|||Count of Participants
2563434|NCT02624986|Secondary|Baseline Value and Change From Baseline Values of Body Temperature at Specified Timepoints|Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance|Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6, end of induction, and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (1 cycle is 28 days)|Safety Population: participants who received at least one dose of any component of the combination treatment. The number analyzed includes participants who were evaluable at each timepoint.|||degrees Celsius (C)||Standard Deviation|Mean
2563435|NCT02624986|Secondary|Baseline Value and Change From Baseline Values of Respiratory Rate at Specified Timepoints|Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance|Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6, end of induction, and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (1 cycle is 28 days)|Safety Population: participants who received at least one dose of any component of the combination treatment. The number analyzed includes participants who were evaluable at each timepoint.|||breaths per minute||Standard Deviation|Mean
2563436|NCT02624986|Secondary|Baseline Value and Change From Baseline Values of Pulse Rate at Specified Timepoints|Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance|Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6, end of induction, and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (1 cycle is 28 days)|Safety Population: participants who received at least one dose of any component of the combination treatment. The number analyzed includes participants who were evaluable at each timepoint.|||beats per minute||Standard Deviation|Mean
2563437|NCT02624986|Secondary|Baseline Value and Change From Baseline Values of Diastolic Blood Pressure at Specified Timepoints|Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance|Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6, end of induction, and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (1 cycle is 28 days)|Safety Population: participants who received at least one dose of any component of the combination treatment. The number analyzed includes participants who were evaluable at each timepoint.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2563438|NCT02624986|Secondary|Baseline Value and Change From Baseline Values of Systolic Blood Pressure at Specified Timepoints|Vital signs were measured prior to the infusion while the participant was in a seated position. The baseline value at visit and the change from baseline value at each timepoint are reported. The change from baseline value was calculated by subtracting the post-baseline value from the baseline value. Maint. = maintenance|Baseline, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2-6, end of induction, and then every 2 months (FL) or every month (DLBCL) until end of maintenance or consolidation treatment, respectively (1 cycle is 28 days)|Safety Population: participants who received at least one dose of any component of the combination treatment. The number analyzed includes participants who were evaluable at each timepoint.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2563439|NCT02624986|Secondary|Safety Summary of the Number of Participants With at Least One Adverse Event by Type and Severity According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0)|"The adverse event (AE) severity grading scale for the NCI CTCAE v4.0 was used for assessing AE severity. Any AEs that were not specifically listed in the NCI CTCAE, v4.0 were graded per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. The terms severe and serious are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade."|From first dose until 90 days after the last dose of study drug treatment (up to 31 months)|Safety Population: participants who received at least one dose of any component of the combination treatment.|||Participants|||Count of Participants
2563440|NCT02624986|Secondary|Serum Rituximab Concentrations in DLBCL Participants at Nominal Sampling Timepoints||Pre-infusion (0 hours) at Cycle 1, Day 1 and Cycle 2, Day 1; Post-infusion 0.5 hours at Cycle 1, Day 1 (1 cycle is 28 days)|Pharmacokinetics Evaluable Population: all participants who received at least one dose of study drug. This analysis only includes DLBCL participants who received rituximab. The number analyzed includes participants who were evaluable at each timepoint.|||micrograms per millilitre (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2563441|NCT02624986|Secondary|Serum Obinutuzumab Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints||Pre-infusion (0 hour) and 0.5 hours after end of obinutuzumab infusion on Day 1 of Cycles 1, 2, 4, and 6|Pharmacokinetics Evaluable Population: all participants who received at least one dose of study drug. This analysis only includes FL and DLBCL participants who received obinutuzumab. The number analyzed includes participants who were evaluable at each timepoint.|||micrograms per millilitre (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2563442|NCT02624986|Secondary|Plasma Idasanutlin Concentrations in DLBCL and FL Participants at Nominal Sampling Timepoints Grouped by Idasanutlin Dose and Combination Partner (Obinutuzumab or Rituximab)|The concentration of idasanutlin was determined using a validated assay. The duplication of the predose timepoint (0 hours) on Day 5 as an additional 24-hour timepoint on Day 5 was done in order to conduct pharmacokinetics analysis via non-compartmental analysis, and to derive idasanutlin exposure estimates up to the 24-hour post Day 5 dosing.|Predose (0 hours) and 6 hours postdose on Day 1 of Cycles 1, 2, and 4; Predose (0 hours) and 2, 4, 6, and 24 hours postdose on Day 5 of Cycles 1 and 2; Predose (0 hours) and 6 and 24 hours postdose on Cycle 4, Day 5 (1 cycle is 28 days)|Pharmacokinetics Evaluable Population: all participants who received at least one dose of study drug. For this analysis, FL and DLBCL participants are grouped by idasanutlin dose and combination drug (obinutuzumab or rituximab). The number analyzed includes participants who were evaluable at each timepoint.|||nanograms per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2563443|NCT02624986|Secondary|Percentage of Participants With Best Response of Complete Response or Partial Response During the Study, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria|The investigator was to evaluate responses throughout the study using the Lugano 2014 response criteria for malignant lymphoma for a CT-based best response of a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a ≥50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by >50% in length. Participants without a post-baseline tumor assessment were to be considered non-responders.|Baseline, Cycle 2, end of induction (up to 6 cycles; 1 cycle is 28 days), every 2 months (FL) until end of maintenance or at 4 months (DLBCL) of consolidation treatment, and then every 6 months during follow-up until disease progression (up to 3.5 years)|The study plan was for this efficacy analysis to be based on responses in participants enrolled during the expansion phase (Phase 2), but it was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Phase 1).||||||
2563471|NCT02624492|Secondary|Complete Response (CR) by Central Review Assessment- Phase II|Complete Response (CR) by central review assessment- Phase II; CR: Disappearance of all evidence of disease. Sponsor discontinued the trial for strategic reasons. Consequently, Phase II of the trial was not conducted and hence the endpoint is not evaluated.|up to 32 weeks from first trial medication administration.|Primary and secondary endpoints of Phase II are not applicable (NA) since Phase II has not been conducted||||||
2563472|NCT02624492|Secondary|Maximum Measured Plasma Concentration of BI 836826 (Cmax)- Phase 1b|Pharmacokinetic analyses were planned to be performed. However, after encountering technical difficulties and discontinuation of the BI 836826 programme, the sponsor decided not to re-analyse the samples.|up to 32 weeks from first trial medication administration.|PK parameters were not calculated because the sponsor discontinued development of BI 836826||||||
2566427|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: LDL||Baseline, Week 24|Participants with measurements at given time point.|||mmol/L||Standard Deviation|Mean
2563444|NCT02624986|Secondary|Percentage of Participants With Objective Response at the End of Induction, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria|The investigator was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a ≥50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by >50% in length. Participants without a post-baseline tumor assessment were to be considered non-responders.|Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)|The study plan was for this efficacy analysis to be based on responses in participants enrolled during the expansion phase (Phase 2), but it was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Phase 1).||||||
2563445|NCT02624986|Secondary|Percentage of Participants With Objective Response at the End of Induction, Determined by an IRC on the Basis of CT Scans Alone Using Lugano 2014 Criteria|The IRC was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a CT-based objective response: either a complete (CR) or partial response (PR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 cm in the LDi; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). The PR criteria required all of the following: a ≥50% decrease in sum of the product of perpendicular diameters of up to 6 target measurable nodes and extranodal sites; no new lesions; non-measured lesion that is absent/normal, regressed, but no increase; and spleen must have regressed by >50% in length. Participants without a post-baseline tumor assessment were to be considered non-responders.|Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)|The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Phase 2), but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Phase 1).||||||
2563446|NCT02624986|Secondary|Percentage of Participants With Objective Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Lugano 2014 Criteria|The investigator was to evaluate responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based objective response: either a complete (CR) or partial response (PR). A CR required a complete metabolic response with a score of 1, 2, or 3 on the PET 5-point scale (5PS) for 18-fluorodeoxyglucose (FDG) uptake (scores range from 1 [no uptake above background] to 5 [uptake markedly higher than liver and/or new lesions]), with or without a residual mass in lymph nodes and extralymphatic sites; and a PR required a partial metabolic response with a score of 4 or 5 on the 5PS with reduced 18-FDG uptake compared with baseline and residual mass(es) of any size. For bone marrow involvement, the CR criteria required no evidence of FDG-avid disease, and the PR criteria required residual uptake higher than in normal marrow but reduced compared with baseline. Participants without a post-baseline tumor assessment were to be considered non-responders.|Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)|The study plan was for this efficacy analysis to be based on responses in participants enrolled during the expansion phase (Phase 2), but it was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Phase 1).||||||
2563447|NCT02624986|Secondary|Percentage of Participants With Objective Response at the End of Induction, Determined by the IRC on the Basis of PET-CT Scans Using Lugano 2014 Criteria|The IRC was to evaluate responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based objective response: either a complete (CR) or partial response (PR). A CR required a complete metabolic response with a score of 1, 2, or 3 on the PET 5-point scale (5PS) for 18-fluorodeoxyglucose (FDG) uptake (scores range from 1 [no uptake above background] to 5 [uptake markedly higher than liver and/or new lesions]), with or without a residual mass in lymph nodes and extralymphatic sites; and a PR required a partial metabolic response with a score of 4 or 5 on the 5PS with reduced 18-FDG uptake compared with baseline and residual mass(es) of any size. For bone marrow involvement, the CR criteria required no evidence of FDG-avid disease, and the PR criteria required residual uptake higher than in normal marrow but reduced compared with baseline. Participants without a post-baseline tumor assessment were to be considered non-responders.|Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)|The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Phase 2), but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Phase 1).||||||
2563473|NCT02624492|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point After Drug Administration (AUC0-tz) of BI 836826- Phase 1b|Pharmacokinetic (PK) analyses were planned to be performed. However, after encountering technical difficulties and discontinuation of the BI 836826 programme, the sponsor decided not to re-analyse the samples.|up to 32 weeks from first trial medication administration.|PK parameters were not calculated because the sponsor discontinued development of BI 836826||||||
2563474|NCT02624492|Secondary|Overall Response Based on Investigator's Assessment- Phase 1b|Overall response based on investigator's assessment, i.e. partial remission (PR) and complete remission (CR) by investigator assessment; CR: Disappearance of all evidence of disease PR: Regression of measurable disease and no new sites|up to 32 weeks from first trial medication administration.|Treated set|||participants|||Number
2563745|NCT02620787|Secondary|Tedizolid AUC in Plasma|The area under the plasma drug concentration-time curve (AUC) reflects the actual plasma exposure to drug after administration of a dose of the drug and is expressed in mg*h/L|48-72 hours||||mg*h/L||Standard Deviation|Mean
2563448|NCT02624986|Secondary|Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of CT Scans Alone Using Lugano 2014 Criteria|The investigator evaluated responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a computed tomography (CT)-based complete response (CR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 centimetres in the longest transverse diameter of a lesion [LDi]; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were to be considered non-responders.|Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)|ITT Population: all enrolled participants; exploratory analysis of the dose escalation phase (Phase 1). The study plan was for efficacy analyses to be based on responses in participants enrolled during the expansion phase (Phase 2), but it was not opened (i.e., no enrollment) and the study was terminated early.|||Percentage of participants||90% Confidence Interval|Number
2563449|NCT02624986|Secondary|Percentage of Participants With Complete Response at the End of Induction, Determined by the IRC on the Basis of CT Scans Alone Using Lugano 2014 Criteria|The IRC was to evaluate responses at the end of induction treatment using the Lugano 2014 response criteria for malignant lymphoma for a computed tomography (CT)-based complete response (CR). The CR criteria required a complete radiologic response with all of the following: target nodes/nodal masses must regress to less than or equal to 1.5 centimetres in the longest transverse diameter of a lesion [LDi]; no extralymphatic sites of disease; no non-measured or new lesions; enlarged organs regressing to normal size; and bone marrow normal by morphology (if indeterminate, immunohistochemistry negative). CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were to be considered non-responders.|Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)|The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Phase 2), but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Phase 1).||||||
2563450|NCT02624986|Secondary|Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Lugano 2014 Criteria|The investigator evaluated responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based complete response (CR), which required a complete metabolic response with a score of 1, 2, or 3 with or without a residual mass in lymph nodes and extralymphatic sites on the PET 5-point scale for 18-fluorodeoxyglucose (FDG) uptake (1 = no uptake above background; 2 = uptake less than or equal to [≤] mediastinum; 3 = uptake greater than [>] mediastinum and ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly > liver and/or new lesions; X = new areas of uptake unlikely to be related to lymphoma). The CR criteria for participants with bone marrow involvement at screening required no evidence of FDG-avid disease in the marrow. PET-CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were considered non-responders.|Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)|ITT Population: all enrolled participants; exploratory analysis of the dose escalation phase (Phase 1). The study plan was for efficacy analyses to be based on responses in participants enrolled during the expansion phase (Phase 2), but it was not opened (i.e., no enrollment) and the study was terminated early.|||Percentage of participants||90% Confidence Interval|Number
2563451|NCT02624986|Secondary|Percentage of Participants With Complete Response at the End of Induction, Determined by the Investigator on the Basis of PET-CT Scans Using Modified Lugano 2014 Criteria|The investigator evaluated responses at the end of induction treatment using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based complete response (CR), which required a complete metabolic response with a score of 1, 2, or 3 with or without a residual mass in lymph nodes and extralymphatic sites on the PET 5-point scale for 18-fluorodeoxyglucose (FDG) uptake (1 = no uptake above background; 2 = uptake less than or equal to [≤] mediastinum; 3 = uptake greater than [>] mediastinum and ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly > liver and/or new lesions). The CR criteria were slightly modified to require normal bone marrow by morphology (if indeterminate, immunohistochemistry negative). PET-CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were considered non-responders.|Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)|ITT Population: all enrolled participants; exploratory analysis of the dose escalation phase (Phase 1). The study plan was for efficacy analyses to be based on responses in participants enrolled during the expansion phase (Phase 2), but it was not opened (i.e., no enrollment) and the study was terminated early.|||Percentage of participants||90% Confidence Interval|Number
2563452|NCT02624986|Secondary|Number of Participants With a Dose-Limiting Toxicity|A dose-limiting toxicity (DLT) was defined as at least one of the following events occurring during Cycle 1 (or first 2 cycles in the bridging FL cohort) of treatment and assessed by the investigator as not clearly related to the underlying disease: Any Grade 5 adverse event (AE; severity graded per NCI-CTCAE v4.0) unless due to the underlying malignancy or extraneous causes; AE of any grade that leads to a delay of more than (>)14 days in the start of the next treatment cycle; Grade 3 or 4 non-hematologic AEs (with exceptions); Lab results suggestive of potential drug-induced liver injury (according to Hy's law); Grade 3 or 4 neutropenia in the presence of sustained fever of >38 C (lasting >5 days) or a documented infection; Grade 4 neutropenia or thrombocytopenia lasting >7 days; Grade 3 or 4 thrombocytopenia if associated with Grade ≥3 bleeding; Other toxicities considered clinically relevant and related to study treatment as determined by the investigator and medical monitor.|Cycles 1, 2 (1 cycle is 28 days)|Safety Population: participants who received at least one dose of any study drug.|||Participants|||Count of Participants
2563517|NCT02623803|Secondary|Overall Pain|Overall pain will be measured approximately 12 hours post-operatively using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.|approximately 12 hours post-operatively||||score on a scale||Standard Deviation|Mean
2563453|NCT02624986|Primary|Percentage of Participants With Complete Response at the End of Induction, Determined by an Independent Review Committee (IRC) on the Basis of Positron Emission Tomography and Computed Tomography (PET-CT) Scans Using Modified Lugano 2014 Criteria|The plan was for the IRC to evaluate responses at the end of induction treatment in participants from the expansion phase using Lugano 2014 criteria for malignant lymphoma for a PET-CT-based complete response (CR), which required a complete metabolic response with a score of 1, 2, or 3 with or without a residual mass in lymph nodes and extralymphatic sites on the PET 5-point scale for 18-fluorodeoxyglucose (FDG) uptake (1 = no uptake above background; 2 = uptake less than or equal to [≤] mediastinum; 3 = uptake greater than [>] mediastinum and ≤ liver; 4 = uptake moderately > liver; 5 = uptake markedly > liver and/or new lesions). The CR criteria were slightly modified to require normal bone marrow by morphology (if indeterminate, immunohistochemistry negative). PET-CT scans were performed at end of induction only on participants who had received at least 2 cycles of induction treatment; those without a post-baseline tumor assessment were to be considered non-responders.|Within 6 to 8 weeks after Day 1 of Cycle 6 (up to approximately 28 weeks; 1 cycle is 28 days)|The study plan was for the IRC to analyze the efficacy results in participants from the expansion phase (Phase 2), but the expansion phase was not opened (i.e., no enrollment) because the sponsor decided to terminate the study early due to the modest benefit achieved with the maximum tolerated dose during the dose escalation phase (Phase 1).||||||
2563454|NCT02624791|Secondary|Operational Composite Score|Z-score composite of operational testing outcomes|1 day laboratory study||||Z score||Standard Deviation|Mean
2563455|NCT02624791|Primary|Tactical Composite Score|Z-score composite of tactical testing outcomes|1 day laboratory study||||Z score||Standard Deviation|Mean
2563456|NCT02624713|Primary|Family Eating and Activity Habits Questionnaire 32|"Family Eating and Activity Habits questionnaire (FEAHQ-32) filled out by the participating parents (only in the prospective research group). The FEAHQ is a 32-item self-report instrument designed to assess the eating and activity habits of family members as well as obesogenic factors in the overall home environment (stimulus and behaviour patterns) related to weight. The higher the score, the greater the obsogenic load in a family so its a worse outcome. The lower the score, the less obsogenic load in the family so its a better outcome. There is no minimum or maximum score as reported by Golan & Weizman, 1998 (See reference 5). The score varies from family to family according to the number of persons.The goal is to get a lower score relative to the initial score. The FEAHQ-32 has been validated in English and Hebrew.~This measure was only used to assess the Prospective Research group, as also mentioned under research instruments in the detailed study description."|"Before the program (time 1), at the end of the program (after 6 months - time 2) and 8 months after completing the program (after a total of 14 months from baseline, time 3)"|42 Parents answered the questionnaire before and after the program, and follow up.|||score on a scale||Standard Error|Mean
2563457|NCT02624713|Primary|Number of Participants With >20 on the 26 Children Eating Attitudes Test|Children Eating Attitudes Test- 26 items. The Children Eating Attitudes has been validated for children and adolescents. The items are rated on a 6-point scale: (1) never, (2) rarely, (3) sometimes, (4) often, (5) usually, and (6) always. Scores range from 0 (minimum) to 78 (maximum). Scores above 20 indicates a high level of concern about dieting, body weight, or problematic eating behaviors. Higher scores (above 20) are considered a worse outcome.|"Before the program (time 1), at the end of the program (after 6 months - time 2) and 8 months after completing the program (after a total of 14 months from baseline, time 3)"||||Participants|||Count of Participants
2563458|NCT02624687|Secondary|Sedentary Behavior|Self-reported hours per day|6 months|ITT LOCF|||hours/day||Standard Error|Least Squares Mean
2563459|NCT02624687|Secondary|Physical Activity|Minutes per week of moderate-to-vigorous physical activity by self-report|6 months|ITT LOCF|||minutes/week||Standard Error|Least Squares Mean
2563460|NCT02624687|Secondary|Work Productivity|Health and Work Questionnaire. Higher total score indicates better work productivity (range 0-240 points).|6 months||||points||Standard Deviation|Mean
2563461|NCT02624687|Secondary|Presenteeism|Stanford Presenteeism Scale. A higher score indicates higher presenteeism (range 6-30 points).|6 months||||points||Standard Deviation|Mean
2563462|NCT02624687|Secondary|Unloaded Reach Test|Distance on an unloaded reach test (cm). Greater distance indicates better function.|6 months||||cm||Standard Deviation|Mean
2563463|NCT02624687|Secondary|Timed up and go Test|Timed up and go test (seconds). A lower time indicates better function.|6 months||||seconds||Standard Deviation|Mean
2563464|NCT02624687|Secondary|Chair Stand Test|Time to complete 5 sit-to-stand transitions (seconds). Lower time indicates better function.|6 months||||seconds||Standard Deviation|Mean
2563465|NCT02624687|Secondary|50-ft Walk Test|Time to complete 50 ft. walk test (seconds) at usual pace. Lower time indicates better function.|6 months||||seconds||Standard Deviation|Mean
2563466|NCT02624687|Secondary|Mood|Profile of Mood States Questionnaire. Total mood disturbance score reported here. Higher scores indicate higher mood disturbance (range 0-200 points).|6 months||||points||Standard Deviation|Mean
2563467|NCT02624687|Secondary|Quality of Life (Self-reported)|36-item Short Form Survey (SF-36). This validated survey collects information on quality of life, with scores ranging from 0-100, and where higher scores indicate higher quality of life.The General Health Score is reported.|6 months||||points||Standard Deviation|Mean
2563468|NCT02624687|Primary|Usual Low Back Pain|Pain rated by Visual Analog Scale (Usual Back Pain). This score ranges from 1-10 where a higher score indicates worse pain.|6 months|ITT LOCF|||points (out of 10)||Standard Error|Least Squares Mean
2563469|NCT02624687|Primary|Low Back Pain Disability|Oswestry Disability Index. This measurements is reported as a % (range 1-100%) where a higher score indicates worse low back pain disability.|6 months|ITT LOCF|||Oswestry Disability %||Standard Error|Least Squares Mean
2563470|NCT02624492|Primary|Overall Response, i.e. CR and PR, by Central Review Assessment- Phase II|Overall response based on central review assessment, i.e. CR and PR by central review assessment; CR: Disappearance of all evidence of disease PR: Regression of measurable disease and no new sites. Sponsor discontinued the trial for strategic reasons. Consequently, Phase II of the trial was not conducted and hence the endpoint is not evaluated.|up to 32 weeks from first trial medication administration|Primary and secondary endpoints of Phase II are not applicable (NA) since Phase II has not been conducted||||||
2563476|NCT02624492|Primary|Number of Patients With Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) Evaluation Period- Phase 1b|DLT definition included both non-haematologic and haematologic drug-related Adverse events (AEs). Non-haematologic AEs of Common Toxicity Criteria for Adverse Events (CTCAE) Grade 3 or higher qualified for DLTs with the following exceptions: laboratory abnormalities that could be corrected with treatment within 48 h; nausea, vomiting, or diarrhoea which resolved within 48 h with adequate treatment; neuropathy considered related to oxaliplatin; or an infusion-related reactions (IRR). For haematologic AEs, the following were considered DLTs: Grade 4 neutropenia lasting >7 days (d) despite growth factors support; any febrile neutropenia which did not resolve within 48 hours with appropriate treatment; Grade 4 thrombocytopenia lasting >7 d or Grade 3/4 thrombocytopenia with clinically significant bleeding; failure to recover platelets ≥75*10^9/litres (L) by 4 weeks after start of the cycle; or failure to recover neutrophils ≥1.0*10^9/L by 4 weeks after start of the cycle.|14 days from first trial medication|MTD evaluation set: The MTD evaluation set includes all patients who were documented to have received at least 1 dose of BI 836826 and were not replaced for the MTD evaluation.|||participants|||Number
2563477|NCT02624375|Secondary|Number of Participants With Adverse Events Due to Zostavax|To measure the occurrence of adverse events after Zostavax.|6 months||||Participants|||Count of Participants
2563478|NCT02624375|Primary|Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Skin|To determine if shingles disease boosts the local level of VZV-specific T cells in skin 4 weeks after Zostavax|4 weeks||||Percentage of CD4 T cells||Inter-Quartile Range|Median
2563479|NCT02624375|Primary|Percentage of Th1 Cytokine Positive VZV-specific CD4 T-cells in Blood|To determine if Zostavax, when given as FDA indicated, boosts VZV-specific T-cells in the blood|6 months|10 persons 70 and older who received Zostavax|||percentage of CD4 T cells||Inter-Quartile Range|Median
2563480|NCT02624284|Secondary|Number of Days Abstinent From Cigarettes During Monitored Abstinence Period|Number of days of biochemically verified abstinence during the monitoring period will be recorded.|Assessed during 7-day monitored abstinence period during study days 6 - 12||||Days||Standard Deviation|Mean
2563481|NCT02624284|Secondary|Urge to Smoke for Negative Affect Relief|"The 10-item brief QSU (QSU-B) questionnaire will be used to assess smoking urges. The QSU-B contains 2 subscales (anticipation of reward, relief from negative affect). The QSU-B with a Right Now frame of reference will be administered before the smoking resist paradigm. Urge to smoke for negative affect relief (QSU-B Factor 2) has been linked to outcomes for the smoking resist paradigm. The range of possible scores is 4 to 28, with higher scores indicating greater urges."|During laboratory session on day 5, assessed for up to 2 hours||||units on a scale||Standard Deviation|Mean
2563482|NCT02624284|Primary|Resisting Smoking - Number of Cigarettes Smoked in the Resist Smoking Paradigm|Participant smoking behavior will be assessed during the laboratory session using a validated smoking lapse paradigm. The primary outcome measure is number of cigarettes smoked.|During laboratory session on day 5, assessed for up to 2 hours||||cigarettes||Standard Deviation|Mean
2563483|NCT02624284|Primary|Resisting Smoking - Time to First Cigarette in the Resist Smoking Paradigm|Participant smoking behavior will be assessed during the laboratory session using a validated smoking lapse paradigm. The primary outcome measure is time to first cigarette in minutes.|During laboratory session on day 5, assessed for up to 2 hours||||minutes||Standard Deviation|Mean
2563484|NCT02624050|Secondary|Blood Levels of AVP (at Baseline (Time 0) and 3,5,10 and 15 Min) for Participants Who Received AVP for Refractory Hypotension|Serum concentrations of AVP at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min), following anesthetic induction, determined for Participants who did not receive AVP for refractory hypotension|Time 0,3,5,10 and 15 min following anesthetic induction|Blood samples were not available for some participants at some time points|||pg/ml||Standard Deviation|Mean
2563485|NCT02624050|Secondary|Blood Levels of Arginine Vasopressin (AVP) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction) for Participants Who Did Not Receive AVP for Refractory Hypotension|Serum concentrations of AVP at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction determined for participants who did not receive AVP for refractory hypotension|Time 0,3,5,10 and 15 min following anesthetic induction|Blood samples were not available for some participants at some time points|||pg/ml||Standard Deviation|Mean
2563486|NCT02624050|Secondary|Blood Levels of Angiotensin II (AII) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction)|Serum concentrations of Angiotension II at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction|Time 0,3,5,10 and 15 min following anesthetic induction|Blood samples were not available for some participants at some time points|||pg/ml||Standard Deviation|Mean
2563487|NCT02624050|Secondary|Blood Levels of Epinephrine (at Baseline (Time 0) and 3,5,10 and 15 Min After Induction of Anesthesia)|Serum concentrations of Epinephrine at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction|Time 0,3,5,10 and 15 min following anesthetic induction|Blood Samples were not available for some participants at some time points.|||pg/ml||Standard Deviation|Mean
2563488|NCT02624050|Secondary|Serum Concentration of Norepinephrine (NE) (at Baseline (Time 0) and 3,5,10 and 15 Min After Anesthetic Induction)|Serum concentrations of NE at predetermined time points (Baseline (Time 0) and 3,5,10 and 15 min) following anesthetic induction|Time 0,3,5,10 and 15 min following anesthetic induction|Blood samples were not available for some participants at some time points.|||pg/ml||Standard Deviation|Mean
2563489|NCT02624050|Secondary|Heart Rate|Heart rate will be measured through standard monitoring.|Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction||||bpm||Standard Deviation|Mean
2563490|NCT02624050|Secondary|Diastolic Blood Pressure|Diastolic blood pressure will be measured through standard monitoring.|Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction||||mm Hg||Standard Deviation|Mean
2563491|NCT02624050|Secondary|Systolic Blood Pressure|Systolic blood pressure will be measured through standard monitoring.|Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction||||mm Hg||Standard Deviation|Mean
2563492|NCT02624050|Secondary|Duration of Each Hypotension Episode|This is the length of time that systolic blood pressure was either: (1) < 85 mmHg, or (2) a decrease of more than 30% from the individual's baseline SBP.|Hemodynamic measurements will be taken during the first 15 minutes of anesthetic induction||||min||Standard Deviation|Mean
2563496|NCT02623959|Primary|The Primary Outcomes of Interest Will be Time to Catheter Removal.|This outcome will be analyzed by cause-specific hazard Cox model with treatment group as a covariate. Whenever a catheter is removed the cause for removal will be documented. For the analysis causes will include removal due to decreased drainage (i.e. as per plan) as well as removal due to complications (e.g. infection, empyema, and refractory pain) or other reasons (e.g. catheter plugged but no complication to the patient, patient preference without a complication).|1 month|Due to slow accrual and the design of the study the protocol was terminated. No data was collected and no analysis was done.||||||
2563497|NCT02623855|Secondary|Change in Park Visits Per Week|Self-reported number of park visits in the last week, measured at 0, 1, and 3 months.|3 month||||park visits/week||95% Confidence Interval|Mean
2563498|NCT02623855|Secondary|Change in Cortisol Level in Parents|Salivary cortisol from parents|1 month||||change in ug/dL||95% Confidence Interval|Mean
2563499|NCT02623855|Secondary|Change in Minutes of Moderate Physical Activity Per Day|"Parents will report their physical activity in terms of minutes of moderate physical activity in the week before follow up at 0, 1months follow up.~Pedometers were also given to participants. Of note, because of poor follow through with returning pedometer data, this variable was not analyzed in the study results."|1 month|Minutes of moderate physical activity per average day in the week prior to follow up at 0, 1 and 3 months was measured. Below we list the mean within group change of minutes of moderate physical activity per day.|||change in minutes/day||95% Confidence Interval|Mean
2563500|NCT02623855|Secondary|Change in Cortisol Level in Parents|Salivary cortisol from parents|3 months||||change in ug/dL||95% Confidence Interval|Mean
2563501|NCT02623855|Secondary|Change in Minutes of Moderate Physical Activity Per Day|"Parents will report their physical activity in terms of minutes of moderate physical activity in the week before follow up at 0, 1, and 3 months out.~Pedometers were also given to participants. Of note, because of poor follow through with returning pedometer data, this variable was not analyzed in the study results."|3 months|Minutes of moderate physical activity per average day in the week prior to follow up at 0, 1 and 3 months was measured. Below we list the mean within group change of minutes of moderate physical activity per day.|||change in minutes/day||95% Confidence Interval|Mean
2563502|NCT02623855|Secondary|Change in Park Visits Per Week|Self-reported number of park visits in the last week, measured at 0, 1, and 3 months.|1 month||||park visits/week||95% Confidence Interval|Mean
2563503|NCT02623855|Primary|Change in Stress|measured through the Perceived Stress Score10 (PSS10), a ten item, validated instrument which ranges from 0-40.|1 month||||change in units over time||95% Confidence Interval|Mean
2563504|NCT02623855|Primary|Change in Stress|measured through the Perceived Stress Score10 (PSS10) over 0, 1 and 3 months. The PSS10 is a ten item, validated instrument which ranges from 0-40. Each item on the instrument is summed to create a total score. Higher values correspond with higher stress.|3 months||||change in units over time||95% Confidence Interval|Mean
2563505|NCT02623803|Secondary|Quality of Recovery|This questionnaire is a short 15 question form that measures the quality of a subject's postoperative recovery. The scale is ranked from 0 to 10, where 0 is a poor response and 10 is an excellent response.|Day 15 post-operatively||||score on a scale||Standard Deviation|Mean
2563506|NCT02623803|Secondary|Total Opioid Consumption|Total amount of opioids converted to morphine equivalents in mg administered in the first 24 hours after surgery.|up to 24 hours post-operatively||||mg||Standard Deviation|Mean
2563507|NCT02623803|Secondary|Length of Time to First Bowel Movement|Time of first instance of a bowel movement will be measured as the number of days post operatively for bowel function to return.|up to 3 weeks postoperatively||||days||Standard Deviation|Mean
2563508|NCT02623803|Secondary|Length of Time to First Flatus|Time of first instance of flatus will be measured as the number of days post operatively for bowel function to return.|up to 3 weeks postoperatively||||days||Standard Deviation|Mean
2563509|NCT02623803|Secondary|Pain With Coughing|Pain with coughing will be measured on post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.|post-operative day 1 at 1 pm||||score on a scale||Standard Deviation|Mean
2563510|NCT02623803|Secondary|Pain at Rest|Pain at rest will be measured at post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.|post-operative day 1 at 1 pm||||score on a scale||Standard Deviation|Mean
2563511|NCT02623803|Secondary|Overall Pain|Overall pain will be measured on post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.|post-operative day 1 at 1 pm||||score on a scale||Standard Deviation|Mean
2563512|NCT02623803|Secondary|Pain With Coughing|Pain with coughing will be measured on post-operative day 1 at 1 am using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.|post-operative day 1 at 1 am||||score on a scale||Standard Deviation|Mean
2563513|NCT02623803|Secondary|Pain at Rest|Pain at rest will be measured on post-operative day 1 at 1 am using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.|post-operative day 1 at 1 am||||score on a scale||Standard Deviation|Mean
2563514|NCT02623803|Secondary|Overall Pain|Overall pain will be measured on post-operative day 1 at 1am using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.|post-operative day 1 at 1am||||score on a scale||Standard Deviation|Mean
2563515|NCT02623803|Secondary|Pain With Coughing|Pain with coughing will be measured approximately 12 hours post-operatively using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.|approximately 12 hours post-operatively||||score on a scale||Standard Deviation|Mean
2563516|NCT02623803|Secondary|Pain at Rest|Pain at rest will be measured approximately 12 hours post-operatively using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.|approximately 12 hours post-operatively||||score on a scale||Standard Deviation|Mean
2563522|NCT02623803|Secondary|Pain at Rest|Pain will be measured at rest upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.|baseline - arrival at the PACU||||score on a scale||Standard Deviation|Mean
2563523|NCT02623803|Primary|Opioid Consumption|Total opioid consumption in PACU converted to morphine equivalents in mg.|up to 4 hours post-operatively||||mg||Standard Deviation|Mean
2563524|NCT02623803|Primary|Overall Pain in Postoperative Period|Overall pain will be measured upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.|baseline - arrival at the PACU||||score on a scale||Standard Deviation|Mean
2563525|NCT02623725|Secondary|Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Booster Injection With Either CYD Dengue Vaccine or Placebo|Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: >=39°C; Headache, Malaise, Myalgia, and Asthenia: significant, prevents daily activity.|Within 14 days after booster injection|Analysis was performed on Safety Analysis Set. Here, ‘number analyzed’ = participants with available data for specified category.|||Participants|||Count of Participants
2563526|NCT02623725|Secondary|Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Booster Injection With Either CYD Dengue Vaccine or Placebo|Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions: Pain: significant; prevents daily activity; Erythema and Swelling: >100 millimeters (mm).|Within 7 days after booster injection|Analysis was performed on Safety Analysis Set which included all participants who received either CYD dengue vaccine or placebo.|||Participants|||Count of Participants
2563527|NCT02623725|Secondary|Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo|Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers >=10 (1/dilution).|6 months,12 months, and 24 months post-booster injection in CYD64|Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.|||percentage of participants|||Number
2563528|NCT02623725|Secondary|GMTRs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo|GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT. GMTRs were calculated as the ratio of GMTs post-booster injection and pre-booster injection.|Pre-booster injection (Day 0), 6 months, 12 months, and 24 months post-booster injection in CYD64|Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.|||ratio||95% Confidence Interval|Geometric Mean
2563529|NCT02623725|Secondary|GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo|GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT.|6 months,12 months, and 24 months post-booster injection in CYD64|Analysis was performed on Per-Protocol Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.|||titers (1/dilution)||95% Confidence Interval|Geometric Mean
2563530|NCT02623725|Secondary|Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Following Booster Injection With Either CYD Dengue Vaccine or Placebo|Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers >=10 (1/dilution).|28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64|Analysis was performed on Per-Protocol Analysis Set. Here, ‘number analyzed’ = participants with available data for each specified category.|||percentage of participants|||Number
2563531|NCT02623725|Secondary|GMTRs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo|GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the PRNT. GMTRs were calculated as the ratio of GMTs pre-booster injection and post-dose injection.|28 days post-dose 3 in CYD13 or CYD30 and pre-booster injection (Day 0) in CYD64|Analysis was performed on Per-Protocol Analysis Set. Here, ‘number analyzed’=participants with available data for each specified category.|||ratio||95% Confidence Interval|Geometric Mean
2563532|NCT02623725|Secondary|GMTs of Antibodies Against Each Dengue Virus Serotype Following the Third CYD Dengue Vaccine Injection Received in Study CYD13/CYD30, and Before Booster Injection With Either CYD Dengue Vaccine or Placebo|GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the PRNT.|28 days post-dose 3 in CYD13 or CYD30 and pre-booster injection (Day 0) in CYD64|Analysis was performed on Per-Protocol Analysis Set. Here, ‘number analyzed’ = participants with available data for each specified category.|||titers (1/dilution)||95% Confidence Interval|Geometric Mean
2563533|NCT02623725|Secondary|Percentage of Participants With Seroconversion Against Each Dengue Virus Serotype Following Booster Injection With Either CYD Dengue Vaccine or Placebo|Seroconversion for each serotype was defined as the percentage of participants with either a pre-booster titer <10 (1/dilution) and a post-booster titer >=40 (1/dilution), or a pre-booster titer >=10 (1/dilution) and a >=4-fold increase in post-booster titer as determined by PRNT.|28 days post-booster injection|Analysis was performed on Full analysis set. Here, ‘number analyzed’ = participants with available data for each specified category.|||percentage of participants|||Number
2563534|NCT02623725|Secondary|Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo|Seropositivity against each dengue virus serotype were measured using dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titers greater than or equal to (>=)10 (1/dilution).|Pre-booster injection (Day 0) and 28 days post-booster injection|Analysis was performed on Per-Protocol Analysis Set.|||percentage of participants|||Number
2566428|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Insulin||Baseline, Week 48|Participants with measurements at given time point.|||µEq/mL||Standard Deviation|Mean
2563535|NCT02623725|Secondary|GMTRs of Antibodies Against Each Dengue Virus Serotype Before and Following Booster Injection With Either CYD Dengue Vaccine or Placebo|GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT. GMTRs were calculated as the ratio of GMTs post-booster injection and pre-booster injection.|Pre-booster injection (Day 0) and 28 days post-booster injection|Analysis was performed on Per-Protocol Analysis Set.|||ratio||95% Confidence Interval|Geometric Mean
2563536|NCT02623725|Secondary|GMTs of Antibodies Against Each Dengue Virus Serotype Before And Following Booster Injection (Inj.) With Either CYD Dengue Vaccine or Placebo|GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT.|Pre-booster injection (Day 0) and 28 days post-booster injection|Analysis was performed on Per-Protocol Analysis Set.|||titers (1/dilution)||95% Confidence Interval|Geometric Mean
2563537|NCT02623725|Secondary|GMTs of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group|GMTs of antibodies against each of the 4 dengue virus serotype (parental strains) following booster injection were assessed using PRNT.|28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64|Analysis was performed on Full analysis set which included all participants who received either CYD Dengue Vaccine or placebo and had blood sample drawn and valid post-injection serology results. Here, ‘number analyzed’ = participants with available data for each specified category.|||titers (1/dilution)||95% Confidence Interval|Geometric Mean
2563538|NCT02623725|Primary|Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Booster Injection With CYD Dengue Vaccine in CYD64 Compared to Third CYD Dengue Vaccine Received in CYD13/CYD30: CYD Dengue Vaccine Booster Group|Geometric Mean Titers (GMTs) of antibodies against each of the 4 dengue virus serotype (parental strains) were assessed using the plaque reduction neutralization test (PRNT).|28 days post-dose 3 in CYD13 or CYD30 and 28 days post-booster injection in CYD64|Analysis was performed on Per-Protocol Analysis Set which included all participants who had no protocol deviations from the present study (CYD64). Here, ‘number analyzed’ = participants with available data for each specified category.|||titers (1/dilution)||95% Confidence Interval|Geometric Mean
2563539|NCT02623361|Secondary|Patient Satisfaction|"patient questionaire, patients are contacted 48 h after surgery~patient satisfaction is assessed using a questionnaire, applying a scale from 0 to 10, with 0 indicating not satisfied at all and 10 indicating very satisfied"|48 hours||||units on the numeric rating scale (0-10)||Standard Deviation|Mean
2563540|NCT02623361|Secondary|Leg Strength at Discharge From Ambulatory Center, Surgical Leg|measurement of quadriceps strength (Force) using a dynamometer|2 hours after surgery||||Newton||Standard Deviation|Mean
2563541|NCT02623361|Primary|Numeric Pain Score|highest reported numeric score 0-10 in Post Anesthesia Care Unit (PACU) (primary endpoint) The NRS score is used to rate pain from 0 (no pain) to 10 (worst pain imaginable)|within one hour after surgery|Exclusion criteria for enrollment included age younger than 18 years, contraindications for regional anesthesia, pre-existing neurologic deficits of the lower extremity, and a history of chronic pain requiring chronic opioid medication.|||units on the numeric rating scale (0-10)||Standard Deviation|Mean
2563542|NCT02623348|Secondary|Change in Symptom Severity on Dialysis Symptoms Index|Symptoms range from score of 0 (Not at all bothersome) to 5 (Very Bothersome) over 29 symptoms. Score ranges from 0 - 145|Baseline and 12 weeks||||score on a scale||Inter-Quartile Range|Median
2563543|NCT02623348|Secondary|Change in SDNN (ms)|Standard deviation of N-N intervals as recorded on electrocardiography waveform (ms)|12 weeks||||ms||95% Confidence Interval|Median
2563544|NCT02623348|Secondary|Change in the Short From 36 Vitality Scale|Short Form 36 Vitality Scale (0-100, greater values indicate increased levels of energy/decreased levels of fatigue)|Baseline and 12 weeks||||score on a scale||95% Confidence Interval|Median
2563545|NCT02623348|Secondary|Change in Endothelial Function|Reactive hyperemia index (RHI) using peripheral arterial tonometry. RHI is a non-invasive measure of endothelial function, measured using the EndoPAT 2000 (Itamar Medical). The pulse amplitude in the middle fingers of both hands was recorded for five minutes. A blood pressure cuff was then inflated in one arm (which did not have a vascular access in place) to at least 60 mmHg above systolic blood pressure to achieve full occlusion (minimum 200 mmHg, maximum 300 mmHg). After occlusion for 5 minutes, the cuff was deflated, and the device recorded changes in pulse amplitude for an additional 5 minutes and calculated RHI as the ratio of the post to pre occlusion amplitude of the occluded arm relative to the post to pre occlusion amplitude of the control arm, corrected for baseline vascular tone.|12 weeks||||unitless||95% Confidence Interval|Median
2563546|NCT02623348|Secondary|Change in Total Body Muscle Mass (Adjusted by Height Squared)|(TBMM calculated from measurements of intracellular water from bioimpedance spectrometry)|Baseline and 12 weeks|Note: we were unable to obtain body composition measures from all participants at baseline and 12 weeks (Missing data from: 3 with metal implants, 1 with pacemaker, 2 with poor quality of measurement likely related to fluid shifts)|||kg/m2||Inter-Quartile Range|Median
2563547|NCT02623348|Secondary|Change in Symptom Burden on the Dialysis Symptoms Index|Dialysis symptom index (symptom burden ranges from 0 - 29 symptoms experienced)|Baseline and 12 weeks||||score on a scale||Inter-Quartile Range|Median
2563548|NCT02623348|Secondary|Change in Activities of Daily Living Score|Barthel's Index of Daily Activities (Index range 0-20, higher scores indicate greater functional independence)|Baseline and 12 weeks||||score on a scale||95% Confidence Interval|Median
2563549|NCT02623348|Secondary|Self-reported Physical Functioning|Change in score on the Physical Function scale of the Short-Form 36 Health Survey (scale from 0-100, higher numbers indicate better physical functioning)|Baseline and 12 weeks||||score on a scale||95% Confidence Interval|Median
2563550|NCT02623348|Secondary|Physical Performance|change in score on the Short Physical Performance Battery (0-12), higher scores indicate greater physical performance|Baseline and 12 weeks||||score on a scale||95% Confidence Interval|Median
2563551|NCT02623348|Primary|Physical Activity|change in steps per day from pedometer|Baseline and 12 weeks||||steps/day||95% Confidence Interval|Median
2563564|NCT02623322|Secondary|Maximum Serum Concentration (Cmax) of MHAA4549A||Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose; infusion duration = 2 hours)|The pharmacokinetic (PK)−evaluable population included all participants who received MHA4549A.|||mcg/mL||Standard Deviation|Mean
2563552|NCT02623335|Secondary|Physician Engagement With Patient Measured by Clinic Visit Transcript Coding Using OPTION Coding System|Physician engagement with patient was measured by coding the transcript for the patient's clinic visit, using the Observing Patient Involvement in Decision Making instrument (OPTION) scale. Minimum value for this scale is 0 and maximum is 100. Higher scores indicate increased shared decision making.|Within 2 hours of enrollment in the study|The number of participants analyzed differs from the number of total arm participants due to a low number of cases where full audio recording of clinic visit was unavailable.|||score on a scale||Standard Deviation|Mean
2563553|NCT02623335|Secondary|Number of Participants Who Had Surgery During the Study Period|The total number of participants who had surgery during the study period was tracked through a patient chart review.|From enrollment to end of data collection 3-4 months later|The number of participants analyzed differs from the number of total arm participants due to a low rate of participant drop out from the chart review study activity.|||Participants|||Count of Participants
2563554|NCT02623335|Secondary|Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Anxiety 4a Scale|Changes in family psychological well-being were assessed by participant self-report using the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a scale. Minimum value for this scale is 4 and maximum is 20. Higher values indicate worse well-being.|6-8 weeks post-enrollment, 3-4 months post-enrollment|The number of participants analyzed differs from the number of total arm participants due to a low rate of survey or item non-response.|||score on a scale||Standard Deviation|Mean
2563555|NCT02623335|Secondary|Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Psychosocial Illness Impact- Negative Scale|Changes in family psychological well-being were assessed by participant self-report using the Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact- Negative scale. Minimum value for this scale is 4 and maximum is 20. Higher values indicate worse well-being.|6-8 weeks post-enrollment, 3-4 months post-enrollment|The number of participants analyzed differs from the number of total arm participants due to a low rate of survey or item non-response.|||score on a scale||Standard Deviation|Mean
2563556|NCT02623335|Secondary|Patient and Family Psychological Well-being Measured by Self-report on the PROMIS Psychosocial Illness Impact- Positive Scale|Changes in family psychological well-being were assessed by participant self-report using the Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact- Positive scale. The minimum value for this scale is 4 and the maximum is 16. Higher values indicate better well-being.|6-8 weeks post-enrollment, 3-4 months post-enrollment post-enrollment|The number of participants analyzed differs from the number of total arm participants due to a low rate of survey or item non-response.|||score on a scale||Standard Deviation|Mean
2563557|NCT02623335|Secondary|Participant Autonomy Support Measured by Self-report on the HCCQ Instrument|Participant autonomy support was assessed using the self-report measure Health Care Climate Questionnaire (HCCQ). The minimum value for this scale is 1 and the maximum value is 7. Higher scores indicate greater perceived autonomy support.|24-48 hours after enrollment|The number of participants analyzed differs from the number of total arm participants due to a low rate of survey or item non-response.|||score on a scale||Standard Deviation|Mean
2563558|NCT02623335|Primary|Post-treatment Regret Measured by a Specific Participant Self-report Survey Item|"Post-treatment regret was assessed by the following participant self-report survey item: Looking back, is there anything about your treatment that you would do differently?"|3-4 months post-enrollment|The number of participants analyzed differs from the number of total arm participants due to a low rate of survey or item non-response.|||Participants|||Count of Participants
2563559|NCT02623335|Primary|Perceived Self-efficacy in Patient-physician Interactions Measured by Participant Self-report on the PEPPI-5 Scale|Perceived self-efficacy in patient-physician interactions was measured by participant self-report, using the 5-item Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) scale. Maximum value for this scale is 25 and minimum is 0. Higher scores indicate greater self-efficacy.|24-48 hours after enrollment|The number of participants analyzed differs from the number of total arm participants due to a low rate of survey or item non-response.|||score on a scale||Standard Deviation|Mean
2563560|NCT02623335|Primary|Change in Illness-related Stress Measured by Participant Self-report on MYCaW Instrument|Changes in concerns and well-being were measured using the self-report instrument Measure Yourself Concerns and Well-being (MYCaW) instrument. The minimum value for differences in this scale is -6 and maximum value is 6. Higher scores indicate that problems and concerns have diminished.|24-48 hours after enrollment, 6-8 weeks post-enrollment and 3-4 months post-enrollment|The number of participants analyzed differs from the number of total arm participants due to a low rate of survey or item non-response.|||change in score on a scale||Standard Deviation|Mean
2563561|NCT02623335|Primary|Patient Engagement in Decision Making Measured by Clinic Visit Transcript Coding for Number of and Types of Questions Raised|Patient engagement in decision making was measured by coding the transcript for the patient's clinic visit, using a pre-defined coding scheme that focused on the number and types of questions raised in the audio-recorded treatment decision-making visit. The types of questions that were coded were options questions, expectations questions, risks questions and advance directive questions.|Within 2 hours of enrollment in the study|Due to instances when a full audio recording of the clinic visit was not available, the number of participants analyzed differs from the number of total arm participants.|||Participants|||Count of Participants
2563562|NCT02623322|Secondary|Percentage of Participants With Influenza-Related Deaths||Baseline to Day 100|The safety population included all participants randomized to treatment.|||percentage of participants|||Number
2563563|NCT02623322|Secondary|Time to Alleviation of Symptoms of Influenza A Infection|Time to alleviation of all 7 symptoms (i.e., nasal congestion, sore throat, cough, aches, fatigue, headaches, chills/sweats) was assessed using a rating scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe) for each symptom. The outcome was defined in two ways: time to a total symptom score of <=1 and time to a total symptom score of <=7. Resolution had to be maintained for 24 hours without use of symptom relief medications. For participants who were enrolled with mild symptoms, the symptom score had to be reduced by one point during the study duration.|Baseline to Day 14|ITTI population included all randomized participants who had an influenza A infection confirmed by central PCR. Data are reported for evaluable participants.|||hours||80% Confidence Interval|Median
2563565|NCT02623322|Secondary|Area Under the Concentration-Time Curve (AUC) of MHAA4549A|The AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was measured in micrograms times hours per milliliter (mcg*h/mL).|Up to Day 100 (collections scheduled pre-dose [0 hours]; 60 minutes post-dose; and on Days 3, 5, 7, 30, and 100 post-dose; infusion duration = 2 hours)|Data were collected for this outcome measure.||||||
2563566|NCT02623322|Secondary|Percentage of Participants With Influenza A Relapse/Reinfection||Baseline to Day 100|ITTI population included all randomized participants who had an influenza A infection confirmed by central PCR.|||percentage of participants|||Number
2563567|NCT02623322|Secondary|Percentage of Participants With Complications of Influenza|"Participants with complications of influenza were identified by counting participants with AEs containing the terms, pneumonia, lung, myocarditis, ARDS (acute respiratory distress syndrome), otitis media, or respiratory."|Baseline to Day 100|ITTI population included all randomized participants who had an influenza A infection confirmed by central PCR.|||percentage of participants||80% Confidence Interval|Number
2563568|NCT02623322|Secondary|Percentage of Participants Requiring Antibiotics for Secondary Bacterial Respiratory Infections|"Participants with antibiotic usage for secondary bacterial respiratory infections were identified by counting participants with AEs containing the terms, pneumonia, lung, myocarditis, ARDS (acute respiratory distress syndrome), otitis media, or respiratory."|Baseline to Day 100|The intent-to-treat infected (ITTI) population included all randomized participants who had an influenza A infection confirmed by central PCR.|||percentage of participants||80% Confidence Interval|Number
2563569|NCT02623322|Secondary|Duration of Hospitalization for Influenza-Related Complications||Baseline to Day 100|The intent-to-treat infected (ITTI) population included all randomized participants who had an influenza A infection confirmed by central polymerase chain reaction (PCR).|||days|||Number
2563570|NCT02623322|Secondary|Percentage of Participants Requiring Hospitalization for Influenza-Related Complications||Baseline to Day 100|The intent-to-treat infected (ITTI) population included all randomized participants who had an influenza A infection confirmed by central polymerase chain reaction (PCR).|||percentage of participants|||Number
2563571|NCT02623322|Primary|Percentage of Participants With Adverse Events (AEs)|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.|Baseline to Day 100|The safety population included all participants randomized to treatment.|||percentage of participants|||Number
2563572|NCT02623218|Secondary|Rivermead Post-Concussion Survey|"The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity)."|Post-fight, Post-Acupuncture/Sham - TBI-ACUP and TBI-SHAM groups only|The groups with zero did not take this post-concussion survey because those participants were healthy controls who did not have a concussion.|||Units on a scale||Standard Deviation|Mean
2563573|NCT02623218|Secondary|Changes in Hopkins Verbal Learning Test|The Hopkins Verbal Learning Test consists of a 12-item word list, composed of four words from each of three semantic categories which the patient must learn over three trials. For each trial, the subject is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The score for total recall is the sum of all the correctly-recalled words from each trial, ranging from 0 to 36, with higher scores indicating better recall and retention.|At baseline, post-fight, post-exercise, and post-acupuncture/sham acupuncture|"1 participant in the TBI-SHAM group did not complete the study. Data were not collected for the Post-Exercise Total Recall Raw assessment for all groups, and not for Post Acupuncture/sham Total Recall Raw assessment in the CACUP, C-SHAM and C-EX Arms/Groups."|||Units on a scale||Standard Deviation|Mean
2563574|NCT02623218|Primary|Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA).|"Cerebral blood flow velocity was assessed at baseline, post-fight, and post-acupuncture in the TBI-ACUP arm.~Cerebral blood flow velocity was assessed at baseline, post fight, and post-sham acupuncture in the TBI-SHAM arm.~Cerebral blood flow velocity was assessed at baseline, post exercise, and post-acupuncture in the C-EX arm.~Cerebral blood flow velocity was assessed at baseline, and post-acupuncture in the C-ACUP arm.~Cerebral blood flow velocity was assessed at baseline, and post-sham acupuncture in the C-SHAM arm."|At baseline, post-fight, post-exercise (up to 5 hours from baseline), post acupuncture/post sham acupuncture (within 3 hours from baseline)|1 participant in the TBI-SHAM group did not complete the study|||ml/sec||Standard Deviation|Mean
2563575|NCT02622828|Secondary|World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS2)|The WHO-DAS 2.0 is a generic self-report health status measure, linked to the concepts of health and disability outlined in the International Classification of Functioning, Disability and Health and is intended to identify limitations in six domains with 36 items, including self-care, and community and social functioning experienced over the past 30 days. The WHO-DAS 2.0 is responsive to change, has excellent internal consistency, established content validity, and high convergent validity. The WHO-DAS 2.0 will be used to identify changes in overall health status that occur through the study. Uses a scale of 1-5 - 1=no difficulty and 5=extreme difficulty or cannot do. Sum of items within each domain are then summed across the 6 domains to result in a general disability summary score, converted to a metric from 0-100 with higher score indicating more disability.|Initial and 5 month follow-up|data were not collected||||||
2563576|NCT02622828|Primary|Change in Occupational Performance Using the The Canadian Occupational Performance Measure (COPM) at 5 Months|The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure designed to detect changes in performance and satisfaction in occupations that the individual has self-identified as being important and difficult to perform. The COPM has well-established psychometric properties and will be used as the primary outcome measure and will be used to set treatment goals, determine baseline stability, and detect change in performance of, and satisfaction with, the goals.|Initial and 5 month follow up|data were not collected||||||
2563577|NCT02622724|Post-Hoc|Post-Hoc Analyses Related to the Use of Concomitant Glucocorticoids Medications and Mortality at D28|The overall use of concomitant glucocorticoids treatment in both study treatment groups (active and placebo) were analysed.|Day 28|Subjects who received at least 1 dose of concomitant glucocorticoids during days 0-28|||percentage of participants|||Number
2563578|NCT02622724|Other Pre-specified|Extended Long-term Follow-up Endpoint: Respiratory Functioning (FEV1) at Day 360|Measuring FEV1 (forced expiratory volume in 1 second) assessed pulmonary function (airway obstruction, bronchoconstriction or bronchodilation). FEV1 is the volume exhaled during the first second of a forced expiratory manoeuvre, starting from the level of total lung capacity.|Day 360|Subjects from Full Analysis Set population attending Day 360 visit.|||%FEV1||Standard Deviation|Mean
2563579|NCT02622724|Other Pre-specified|Neurological Functioning (6MWT) at Extended Long-term Follow-up|The 6-minute walk test (6MWT) measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes. According to the ERS/ATS technical standard to which the 6MWT was done, the walk test is done twice and the best result is used. It is an evaluation of the global and integrated responses of all systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood and neuromuscular units and muscle metabolism. The self-paced 6MWT assesses the sub- maximal level of functional capacity and will better reflect the functional exercise level for daily activities. ANOVA parameters estimates (LS Means and 90 % confidence intervals) for the overall treatment difference was analysed.|Day 360|All subjects in Full Analysis Set population who performed atleast one 6MWT test at Day 360, before the study was early terminated.|||maximal distance walked (meters)||Standard Deviation|Mean
2563580|NCT02622724|Other Pre-specified|Extended Long-term Follow-up Exploratory Endpoint: Change in Quality of Life From Baseline to Day 360|Quality of Life was assessed through EQ-5D-3L (EuroQol 5-Dimensions 3-Levels questionnaire). An EQ Visual Analogue Scale (VAS) total score (ranging from 0-100) was measured (0= Worst imaginable health state, 100= Best imaginable health state). The EQ-5D-3L VAS scores are numerically summarised as change from pre-dose (Day 1) to extended long term follow-up (Day 360 visit).|Change from baseline to Day 360|Subjects from Full Analysis Set population who completed QoL questionnaire at Baseline and Day 360. As the study was terminated early, only a limited amount of data were available at the post-baseline time point.|||change score on a scale||Full Range|Median
2563581|NCT02622724|Other Pre-specified|Exploratory, Extended Long-term Follow-up: Overall Mortality at Day 360|Fatalities; as the study was terminated early, the assessment time point for mortality at Day 360 was not reached. Therefore only the overall mortality at study termination is presented.|Day 360 /termination of study|Full Analysis Set, but the study was terminated early. The mortality numbers include 3 study subjects who had SAEs with an onset before the first dose of IMP and who subsequently died.|||Participants|||Count of Participants
2563582|NCT02622724|Other Pre-specified|Pharmacogenetic Analysis|An optional genetic sample was analysed for subjects based on a separate consent. A carrier frequency was analysed for a C/T polymorphism (rs9984723) located in the 3'PRIME_UTR/intron region of IFNAR2-gene, which encodes the beta chain for the IFN-alpha/beta receptor and encompasses a regulatory motif for the glucocorticoid receptor. Biomarker responders were defined by a 3-fold elevation in MxA and a 2-fold in CD73 in comparison to baseline.|Anytime from baseline to Day 28|Only subjects with consent for a genetic sample were analysed. Carriers of the C-allele were analysed in biomarker responders compared to biomarker non-responders. 5 and 6 subjects failed to provide genotype information in analyses for responder and non-responders, respectively.|||Participants|||Count of Participants
2563583|NCT02622724|Other Pre-specified|Changes in Levels of Potential Inflammatory Markers (PIMs)|Evaluation of potential inflammatory markers (PIMs) change from baseline to D14 between treatments arms over time. Potential biomarkers included IL-1ra, IL-6, FGF basic, IP-10 and TNF-α.|From baseline to Day 14|Subjects from Full Analysis Set population for whom samples were available; analysis of last observation performed.|||pg/mL||Standard Deviation|Mean
2563584|NCT02622724|Other Pre-specified|Change in the Treatment-specific Exploratory Biomarker Cluster of Differentiation 73 (CD73) Concentration|Evaluation of Cluster of differentiation 73 (CD73) change from baseline to D14 between treatments arms over time.|From baseline to Day 14|Subjects from Full Analysis Set population for whom samples were available; analysis of last observation performed.|||ng/ml||Standard Deviation|Mean
2563585|NCT02622724|Other Pre-specified|Exploratory Variables Relating to Efficacy: Composite Endpoint (Mortality and Days Free of Mechanical Ventilation) at Day 90|Composite endpoint including mortality and days free of mechanical ventilation (VFDsurv) within 90 days among survivors. Ventilation Free Survival at Day 90 has been classified as Dead, Alive but on a ventilator and Alive and breathing unassisted|Within 90 days|Full Analysis Set (discontinued not included).|||Participants|||Count of Participants
2563586|NCT02622724|Other Pre-specified|Evaluation of Pharmacoeconomics: Number of Days in Hospital|Due to the study terminating early, costs items from hospitals were not collected and pharmacoeconomic analyses could not be done.|Day 28 (or last day in ICU if patient has left the ICU earlier than Day 28, or at withdrawal)|Costs items from hospitals were not collected.||||||
2563587|NCT02622724|Other Pre-specified|Evaluation of Pharmacoeconomics: Number of ICU-free Days|Due to the study terminating early, costs items from hospitals were not collected and pharmacoeconomic analyses could not be done.|Day 28 (or last day in ICU if patient has left the ICU earlier than Day 28, or at withdrawal)|Costs items from hospitals were not collected||||||
2563588|NCT02622724|Other Pre-specified|Evaluation of Pharmacoeconomics: Days Free of Mechanical Ventilation|Due to the study terminating early, costs items from hospitals were not collected and pharmacoeconomic analyses could not be done.|Day 28 (or last day in ICU if patient has left the ICU earlier than Day 28, or at withdrawal)|Costs items from hospitals were not collected||||||
2563589|NCT02622724|Other Pre-specified|Evaluation of Pharmacoeconomics: Days Free of Vasoactive Support|Due to the study terminating early, costs items from hospitals were not collected and pharmacoeconomic analyses could not be done.|Day 28 (or last day in ICU if patient has left the ICU earlier than Day 28, or at withdrawal)|Costs items from hospitals were not collected.||||||
2563590|NCT02622724|Other Pre-specified|Evaluation of Pharmacoeconomics: Days Free of Renal Support|Due to the study terminating early, costs items from hospitals were not collected and pharmacoeconomic analyses could not be done.|Day 28 (or last day in ICU if patient has left the ICU earlier than Day 28, or at withdrawal)|Costs items from hospitals were not collected.||||||
2563591|NCT02622724|Other Pre-specified|Evaluation of Pharmacoeconomics: Days Free of Organ Failure|Due to the study terminating early, costs items from hospitals were not collected and pharmacoeconomic analyses could not be done.|Day 28 (or last day in ICU if patient has left the ICU earlier than Day 28, or at withdrawal)|Costs items from hospitals were not collected.||||||
2563592|NCT02622724|Other Pre-specified|Evaluation of Safety: Laboratory Results|Laboratory safety assessments of biochemistry, haematology and urinalysis were performed daily during the stay at ICU. Laboratory data were classified according to normal ranges as out of range (OOR; not clinically significant), OOR (clinically significant), or OOR (clinically significant and an AE). Laboratory test results were summarised by actual results by baseline and last observation period.|From baseline to Day 28 (or last day in ICU if patient has left the ICU earlier than Day 28, or at withdrawal)|Safety Population -no statistical analyses were made|||Participants|||Count of Participants
2563593|NCT02622724|Other Pre-specified|Evaluation of Safety: Physical Examination|"Physical examination data (covering the major body systems; general appearance, head [ear, nose and throat], cardiovascular, eyes, respiratory, abdomen, urogenital, musculoskeletal, neurological, lymph nodes and skin) were categorized as normal; abnormal, not clinically significant; abnormal, clinically significant or not done. Physical examinations were performed at Screening, then at the Last day in ICU and Day 28 (Out of ICU) or Early Termination, from which the last observation performed is derived. The changes from baseline to the last observations performed are categorized as no change, change clinically significant; change not clinically significant, not done."|From baseline to Last Observation Performed (D28 or last day in ICU if patient has left the ICU earlier than Day 28, or at withdrawal)|Safety population - no statistical analyses were made|||Participants|||Count of Participants
2563594|NCT02622724|Other Pre-specified|Evaluation of Safety: Vital Signs - Blood Pressure|"Vital signs were measured supine pre-dose on Day 1 (baseline) and daily up to Day 28 while the patient was in the ICU. The results at baseline and at last observation performed (LOP) were summarized overall by treatment, variable and time point.~No statistical analyses were made for vital signs."|From baseline to Last Observation Performed (Day 28 or last day in ICU if patient has left the ICU earlier than Day 28, or at withdrawal)|Safety Population - no statistical analyses were made for vital signs.|||mmHg||Standard Deviation|Mean
2563595|NCT02622724|Other Pre-specified|Evaluation of Safety: Vital Signs - Body Temperature|"Vital signs were measured supine pre-dose on Day 1 (baseline) and daily up to Day 28 while the patient was in the ICU. The results at baseline and at last observation performed (LOP) were summarized overall by treatment, variable and time point.~No statistical analyses were made for vital signs."|From baseline to Last Observation Performed (Day 28 or last day in ICU if patient has left the ICU earlier than Day 28, or at withdrawal)|Safety Population - no statistical analyses were made for vital signs.|||degrees Celsius||Standard Deviation|Mean
2563596|NCT02622724|Other Pre-specified|Evaluation of Safety: Vital Signs - Heart Rate|"Vital signs were measured supine pre-dose on Day 1 (baseline) and daily up to Day 28 while the patient was in the ICU. The results at baseline and at last observation performed (LOP) were summarized overall by treatment, variable and time point.~No statistical analyses were made for vital signs."|From baseline to Last Observation Performed (Day 28 or last day in ICU if patient has left the ICU earlier than Day 28, or at withdrawal)|Safety Population - no statistical analyses were made for vital signs.|||bpm||Standard Deviation|Mean
2563597|NCT02622724|Secondary|Long-term Efficacy Endpoints Relating to Neurological Functioning (6MWT)|The 6-minute walk test (6MWT) measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes. According to the ERS/ATS technical standard to which the 6MWT was done, the walk test is done twice and the best result is used. It is an evaluation of the global and integrated responses of all systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood and neuromuscular units and muscle metabolism. The self-paced 6MWT assesses the sub- maximal level of functional capacity and will better reflect the functional exercise level for daily activities. ANOVA parameters estimates (LS Means and 90 % conf.interval) for the overall treatment difference was analysed.|Day 180|All subjects in Full Analysis Set population who performed atleast one 6MWT test at Day 180 visit. Furthest distance walked during the two tests was analysed using an ANOVA model.|||maximum distance walked (meters)||Standard Deviation|Mean
2563598|NCT02622724|Secondary|Long-term Efficacy Endpoints Relating to Respiratory Functioning (FEV1)|Measuring FEV1 (forced expiratory volume in 1 second) assessed pulmonary function (airway obstruction, bronchoconstriction or bronchodilation). FEV1 is the volume exhaled during the first second of a forced expiratory manoeuvre, starting from the level of total lung capacity.|Day 180|Full Analysis Set|||%FEV1||Standard Deviation|Mean
2563599|NCT02622724|Secondary|Long-term Efficacy Endpoint: Change in Quality of Life From Baseline to Day 180|Quality of Life was assessed through EQ-5D-3L (EuroQol 5-Dimensions 3-Levels questionnaire). An EQ Visual Analogue Scale (VAS) total score (ranging from 0-100) was measured (0= Worst imaginable health state, 100= Best imaginable health state). The EQ-5D-3L VAS scores are numerically summarised as change from pre-dose (Day 1) to long term follow-up (Day 180 visit).|Change from baseline to Day 180|Subjects from Full Analysis Set population who completed QoL questionnaire at Baseline and Day 180.|||change score on a scale||Full Range|Median
2563600|NCT02622724|Secondary|Efficacy Endpoint: Evaluation of Pharmacodynamic (PD) Using Myxovirus Resistance Protein A (MxA) Biomarker|Evaluation of MxA biomarker change from baseline to D14 between treatments arms over time.|From baseline to Day 14|Subjects from Full Analysis Set population for whom samples were available; analysis of last observation performed.|||ng/ml||Standard Deviation|Mean
2563601|NCT02622724|Secondary|Efficacy Endpoint: Presence of Neutralising Antibodies to IFN Beta-1a|The immunological response to FP-1201-lyo was assessed by monitoring presence of anti-drug binding antibodies (BAbs) and neutralising antibodies (NAbs) to IFN beta-1a on pre-dose Day 1 and at Day 28, the last day in ICU or early termination (if earlier). The BAbs were determined first, and if present, the NAbs were also determined. Presence of BAbs and NAbs were summarised categorically, using positive/negative classification.|Baseline and Day 28 (or last day in intensive care unit [ICU] or at withdrawal, if earlier)|Full Analysis Set, the subjects who had laboratory evaluation done. Subjects were analysed for IFN beta NAbs only if BAbs were present.|||Participants|||Count of Participants
2563636|NCT02622113|Primary|Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)||Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks|One patient of CANA/CANA group who mistakenly received placebo during TA-7284-11 study, did not continued this study. This patient was included in the full analysis set and was not included in the safety analysis set.|||Participants|||Count of Participants
2563637|NCT02622074|Secondary|Overall Survival (OS) Rate at Month 24||Month 24||2020-11-30|11/2020||||
2563602|NCT02622724|Secondary|Evaluation of Safety: Adverse Events and Deaths|Adverse events (AE) up to Day 28. Per protocol, AEs occurring after Day 28 if the investigator considered a causal relationship with the study drug as well as all deaths up to Day 360 were reported. Treatment-emergent AEs (TEAEs) were defined as AEs that begins or worsens in intensity after at least one dose of study drug has been administered. Serious AEs (SAEs) were defined as any untoward medical occurrence that at any dose resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was an important medical event.|AEs up to Day 28, only related after Day 28 and deaths up to Day 360|The analysis population included all participants who were randomized and received at least 1 dose of study treatment.|||Participants|||Count of Participants
2563603|NCT02622724|Secondary|Other Secondary Efficacy Endpoints: Number of Days in Hospital|Hospitalisation days (including the stay at Intensive Care Units). Patients who died during this period have been assigned a value of 28 for the number of days in ICU or in hospital.|Day 28|Full Analysis Set|||Days||Full Range|Median
2563604|NCT02622724|Secondary|Other Secondary Efficacy Endpoints: Number of ICU-free Days|Number of Intensive Care Unit free days up to Day 28, i.e. the patient is no longer receiving care in ICU. Patients who die during this period have been assigned a value of zero for the number of ICU care free days.|Day 28|Full Analysis Set|||Days||Full Range|Median
2563605|NCT02622724|Secondary|Other Secondary Efficacy Endpoint: Days Free of Mechanical Ventilation|"The total number of days free of mechanical ventilation has been derived from the Patient Status report recorded on each day during the 28-day period. Patients who died during this period have been assigned a value of zero. This variable differs from the calculated Ventilation Free Days (VFD) endpoint, which contribute to the VDFsurv primary efficacy endpoint as it require additional conditions of unassisted breathing (UAB) to be met."|Day 28|Full Analysis Set|||Days||Full Range|Median
2563606|NCT02622724|Secondary|Other Secondary Efficacy Endpoints: Days Free of Vasoactive Support|"Days without vasoactive support. The vasoactive support included catecholamine and non-catecholamine vasopressors, inotropes and vasodilating agents.~Overall, the median number of days free of vasoactive support was 20 days in the active group and 21 days in the placebo group."|Day 28|Full Analysis Set|||Days||Full Range|Median
2563607|NCT02622724|Secondary|Other Secondary Efficacy Endpoints: Days Free of Renal Support|Days without renal support (any renal support was documented). Overall, the median number of days free of renal support was 28 days in the active group and 27 days in the placebo group.|Day 28|Full Analysis Set|||Days||Full Range|Median
2563608|NCT02622724|Secondary|Other Secondary Efficacy Endpoints: Days Free of Organ Failure|The total number of days free of organ failure by Sequential Organ Failure Assessment (SOFA) methodology. Overall, the median number of days free of organ failure was 0 days in both the treatment groups.|Day 28 or last day in intensive care unit [ICU] if patient has left the ICU earlier than Day 28|Full Analysis Set|||Days||Full Range|Median
2563609|NCT02622724|Secondary|Efficacy Endpoint: Mortality in Hospital|This is the number of subjects who died in hospital (i.e. outside of Intensive Care Units) up to Day 28.|Up to Day 28|Full Analysis Set|||Participants|||Count of Participants
2563610|NCT02622724|Secondary|Efficacy Endpoint: Mortality in ICU|All-cause mortality for subjects who died in Intensive Care Units up to Day 28.|Up to Day 28|Full Analysis Set|||percentage of subjects||95% Confidence Interval|Number
2563611|NCT02622724|Secondary|Efficacy Endpoint: All-cause Mortality|Fatalities, mortality all-causes from randomisation up to Day 28|At Day 28|Full Analysis Set (FAS) defined as all randomised subjects that received atleast one dose of study drug.|||percentage of subjects||95% Confidence Interval|Number
2563612|NCT02622724|Primary|Composite Endpoint (VFDsurv; All-cause Mortality and Number of Days Free of Mechanical Ventilation) at Day 28|VFDsurv is a composite measure of all-cause mortality and the number of days free of mechanical ventilation (VFDsurv) within 28 days among survivors. Ventilator-free days (VFDs) correspond to those days when unassisted breathing (UAB) was possible for a complete calendar day. UAB was defined as: spontaneously breathing with face mask, nasal prong oxygen or room air, T-piece breathing, tracheostomy mask breathing, CPAP less than or equal to 5 cmH2O without pressure support or intermittent mandatory ventilation assistance, use of CPAP or BIPAP solely for sleep apnoea management. A patient was reported as ventilator-free after 2 consecutive calendar days of unassisted breathing (a VFD value of 0 is assigned to patients who die without initiating UAB or who require more than 28 days of mechanical ventilation. All patients who die before Day28 are assigned a VFDsurv value of -1).|Day 28|Full Analysis Set (FAS), 296 subjects.|||Days||Full Range|Median
2563613|NCT02622568|Primary|Size of Verrucae (Warts)|Diameter of verrucae (warts) at week 12|12 weeks|Only participants completing study are included in analysis.|||millimeters||Standard Deviation|Mean
2563614|NCT02622321|Secondary|Plasma Trough Concentration of Emicizumab|Plasma concentrations of emicizumab were analyzed using a validated Enzyme Linked Immunosorbent Assay (ELISA). The lower limit of quantification (LLOQ) was 100 nanograms per milliliter (ng/mL).|Arm A: Pre-dose (0 hour [hr]) on Weeks 1-5, 7, 9, 13, 17, 21, 25, 33, 41, 49; Arm B: Pre-dose (0 hr) on Weeks 25-29, 31, 33, 37, 41; Arm C: Pre-dose (0 hr) on Weeks 1-5, 7, 9, 13, 17, 21, 25, 33, 41; Arm D: Pre-dose (0 hr) on Weeks 1-5, 7, 9, 13|Pharmacokinetic (PK) evaluable population included all participants who received at least one dose of emicizumab and had at least one post-dose emicizumab concentration result. Data collection was not planned for time-points in the treatment arms where 0 participants were analyzed.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
2563615|NCT02622321|Secondary|Percentage of Participants With Anti-Emicizumab Antibodies||Baseline up to approximately 1 year|All emicizumab participants included Arms A, C, and D and Arm B participants who switched to receive emicizumab (Arm Bemi). Overall number of participants analyzed=participants with at least one post-baseline antibody assessment.|||percentage of participants|||Number
2563638|NCT02622074|Secondary|Overall Survival (OS) Rate at Month 12|OS was defined as the time from the first dose date of study treatment to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The Kaplan-Meier estimates of the percentage of participants who were surviving at Month 12 are presented.|Month 12|The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.|||Percentage of Participants||90% Confidence Interval|Number
2563616|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: Hemophilia-Specific Quality of Life - Short Form (Haemo-Qol-SF) Questionnaire Total Score in Adolescents Participants (12-17 Years Old)|The Haemo-QoL-SF contains 35 items, which cover nine domains considered relevant for the children's health-related quality of life (physical health, feelings, view of yourself, family, friends, other people, sports and school, dealing with hemophilia and treatment). Items are rated with five respective response options: never, seldom, sometimes, often, and always. Haemo-QoL-SF total score range from 0 to 100, where lower scores reflect better health-related quality of life. Data for this outcome was to be analyzed only if >3 participant (in each arm) have available data.|Week 25|ITT population. Overall number of participants analyzed=participants with available for this outcome measure.|||units on a scale||Standard Deviation|Mean
2563617|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: EQ-5D-5L Index Utility Score|EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The EQ-5D-5L health state profile is designed to record the participant's current health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses from the five domains are used to calculate a single utility index value ranging from 1 to 5, where 1 indicates better health state (no problems) and 5 indicates worst health state (confined to bed).|Week 25|ITT population. Overall number of participants analyzed=participants with available data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2563618|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale Score|EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.|Week 25|ITT population. Overall number of participants analyzed=participants with available data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2563619|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: Haem-A-QoL Questionnaire Total Score in Adult Participants (>/=18 Years Old)|Haem-A-QoL questionnaire has been developed and used in hemophilia A participants. As a hemophilia-specific questionnaire, this measure assesses very specific aspects of dealing with hemophilia. This questionnaire consists of items pertaining to 10 domains specific to living with hemophilia. The 10 domains are: physical health, sports and leisure, school and work, dealing with hemophilia, family planning, feeling, relationships, treatment, view of yourself, and outlook for the future. The total score for each domain range from 0 to 100 with lower scores reflective of better quality of life. Haem-A-QoL Questionnaire Total Score is the average of the all domain scores and range from 0 to 100, with lower scores reflective of better quality of life.|Week 25|ITT population. Overall number of participants analyzed=participants with available data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2563620|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: Hemophilia-Specific Quality of Life (Haem-A-QoL) Questionnaire Physical Health Score in Adult Participants (>/=18 Years Old)|Haem-A-QoL questionnaire has been developed and used in hemophilia A participants. As a hemophilia-specific questionnaire, this measure assesses very specific aspects of dealing with hemophilia. This questionnaire consists of items pertaining to 10 domains specific to living with hemophilia. The 10 domains are: physical health, sports and leisure, school and work, dealing with hemophilia, family planning, feeling, relationships, treatment, view of yourself, and outlook for the future. The total score for each domain range from 0 to 100 with lower scores reflective of better quality of life. Physical Health domain score is reported (range 0 to 100, with lower scores reflective of better physical health).|Week 25|ITT population. Overall number of participants analyzed=participants with available data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2563621|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: ABR for Treated Target Joint Bleeds|Number of treated target joint bleeds over the efficacy period was assessed through ABR using an NB regression model. Treated target joint bleeds included treated (with coagulation factors) joint bleeds in a target joint, defined as a joint in which greater than or equal to (>/=) 3 treated joint bleeds occurred during the last 24 weeks prior to study entry. Bleeds due to surgery/procedure are excluded.|From Baseline up to clinical cut-off date (25 Oct 2016) (up to approximately 1 year)|ITT population|||treated target joint bleeds per year||95% Confidence Interval|Number
2563622|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: ABR for Treated Spontaneous Bleeds|Number of treated spontaneous bleeds over the efficacy period was assessed through ABR using an NB regression model. Treated spontaneous bleeds were defined as treated (with coagulation factors) bleeds with no known contributing factor (e.g., trauma, surgery).|From Baseline up to clinical cut-off date (25 Oct 2016) (up to approximately 1 year)|ITT population|||treated spontaneous bleeds per year||95% Confidence Interval|Number
2563623|NCT02622321|Secondary|Arm C (Prophylactic Treatment): Emicizumab and Arm Cnis: Prophylactic Bypassing Agents in NIS BH29768: ABR for Treated Bleeds|Number of treated bleeds over the efficacy period was assessed through ABR using an NB regression model. Treated bleeds were defined as a bleed for which coagulation factors were administered. Bleeds due to surgery/procedure were excluded. Intra-participant comparison of ABR of treated bleeds prior to study entry, while receiving prophylactic bypassing agents during NIS BH29768 (Arm Cnis), with ABR of treated bleeds on emicizumab prophylaxis (in this study) (Arm C) was reported.|For Arm Cnis: up to 52 weeks before study entry (assessed retrospectively at baseline); for Arm C: From Baseline up to clinical cut-off date (25 Oct 2016) (up to approximately 1 year)|Arm C NIS population included all Arm C participants who participated in NIS BH29768 before study entry and received prophylactic bypassing agents during NIS BH29768.|||treated bleeds per year||95% Confidence Interval|Number
2563655|NCT02621931|Secondary|Injection Site Reaction Adverse Events|Counts of participants who reported treatment-emergent injection site reactions as AEs are summarized. Preferred terms from MedDRA version 18.1 are offered without a threshold applied.|Day 1 to Week 12|Safety population|||Participants|||Count of Participants
2563624|NCT02622321|Secondary|Arm C (Prophylactic Treatment): Emicizumab and Arm Cnis: Prophylactic Bypassing Agents in NIS BH29768: ABR for All Bleeds|Number of all bleeds over the efficacy period was assessed through ABR using an NB regression model. All bleeds included both treated (with coagulation factors) and not treated bleeds. Bleeds due to surgery/procedure were excluded. Intra-participant comparison of ABR of all bleeds prior to study entry, while receiving prophylactic bypassing agents during NIS BH29768 (Arm Cnis), with ABR of all bleeds on emicizumab prophylaxis (in this study) (Arm C) was reported.|For Arm Cnis: up to 52 weeks before study entry (assessed retrospectively at baseline); for Arm C: From Baseline up to clinical cut-off date (25 Oct 2016) (up to approximately 1 year)|Arm C NIS population included all Arm C participants who participated in NIS BH29768 before study entry and received prophylactic bypassing agents during NIS BH29768.|||all bleeds per year||95% Confidence Interval|Number
2563625|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: ABR for Treated Joint Bleeds|Number of treated joint bleeds over the efficacy period was assessed through ABR using an NB regression model. Treated joint bleeds were defined as treated bleeds in a joint associated with unusual sensation (aura) in a joint, in combination with another symptom: unusual sensation, swelling/warmth, pain/decreased range of motion (RoM), difficulty moving the joint. Bleeds due to surgery/procedure were excluded.|From Baseline up to clinical cut-off date (25 Oct 2016) (up to approximately 1 year)|ITT population|||treated joint bleeds per year||95% Confidence Interval|Number
2563626|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm Anis: Episodic Bypassing Agents in NIS BH29768: ABR for Treated Bleeds|Number of treated bleeds over the efficacy period was assessed through ABR using an NB regression model. Treated bleeds were defined as a bleed for which coagulation factors were administered. Bleeds due to surgery/procedure were excluded. Intra-participant comparison of ABR of treated bleeds prior to study entry, while receiving episodic bypassing agents during NIS BH29768 (Arm Anis), with ABR of treated bleeds on emicizumab prophylaxis (in this study) (Arm A) was reported.|For Arm Anis: up to 52 weeks before study entry (assessed retrospectively at baseline); for Arm A: From Baseline up to clinical cut-off date (25 Oct 2016) (up to approximately 1 year)|Arm A NIS population included all Arm A participants who participated in NIS BH29768 before study entry and received episodic bypassing agents during NIS BH29768.|||treated bleeds per year||95% Confidence Interval|Number
2563627|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm Anis: Episodic Bypassing Agents in NIS BH29768: ABR for All Bleeds|Number of all bleeds over the efficacy period was assessed through ABR using an NB regression model. All bleeds included both treated (with coagulation factors) and not treated bleeds. Bleeds due to surgery/procedure were excluded. Intra-participant comparison of ABR of all bleeds prior to study entry, while receiving episodic bypassing agents during non-interventional study (NIS) BH29768 (NCT02476942) (Arm Anis), with ABR of all bleeds on emicizumab prophylaxis (in this study) (Arm A) was reported.|For Arm Anis: up to 52 weeks before study entry (assessed retrospectively at baseline); for Arm A: From Baseline up to clinical cut-off date (25 Oct 2016) (up to approximately 1 year)|Arm A NIS population included all Arm A participants who participated in NIS BH29768 before study entry and received episodic bypassing agents during NIS BH29768.|||all bleeds per year||95% Confidence Interval|Number
2563628|NCT02622321|Secondary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: ABR for All Bleeds|Number of all bleeds over the efficacy period was assessed through ABR using an NB regression model. All bleeds included both treated (with coagulation factors) and not treated bleeds. Bleeds due to surgery/procedure were excluded.|From Baseline up to clinical cut-off date (25 Oct 2016) (up to approximately 1 year)|ITT population|||all bleeds per year||95% Confidence Interval|Number
2563629|NCT02622321|Primary|Arm A (Episodic Treatment): Emicizumab and Arm B (Episodic Treatment): No Emicizumab: Annualized Bleed Rate (ABR) for Treated Bleeds|Number of treated bleeds over the efficacy period was assessed through ABR using a negative binomial (NB) regression model. Treated bleeds were defined as a bleed for which coagulation factors were administered. Bleeds due to surgery/procedure were excluded.|From Baseline up to clinical cut-off date (25 Oct 2016) (up to approximately 1 year)|Intent-to-treat (ITT) population defined as all participants who were randomized to Arm A or Arm B.|||treated bleeds per year||95% Confidence Interval|Number
2563630|NCT02622191|Primary|Lamina Cribrosa (Boundaries of the Retinal Layers) Measurements|Using Spectral Domain optical coherence tomography (SD-OCT), horizontal macular thickness of the lamina cribrosa (boundaries of the retinal layers) is measured in the eyes of each participant in microohms.|1 examination, approximately one hour||||micro-ohms||95% Confidence Interval|Mean
2563631|NCT02622178|Secondary|Retinal Nerve Fiber Layer Thickness|Optical coherence tomography (OCT) images provide measurement of the retinal nerve fiber layer thickness in microns.|1 examination, one hour||||microns (thickness)||Standard Deviation|Mean
2563632|NCT02622178|Primary|Visual Evoked Potential (VEP)|Diopsys Visual evoked potential (VEP) (Diopsys, Inc. Pine Brook, NJ) is used to objectively measure the functional responses of the entire visual pathway from the anterior segment of the eye to the visual cortex. This is the strength of the signal recorded from the back of the head near where vision is processed in the brain while a visual stimulus is presented to patient.|1 examination, one hour|measurement is amplitude in microvolts (uV), the peak strength of the signal, when presented with low contrast stimuli|||microvolts (uV) (amplitude)||Standard Deviation|Mean
2563633|NCT02622113|Secondary|Percentage Change in Body Weight||Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks|Full analysis set, last observation carried forward. Outcome measure for two patients of Placebo/CANA group and one patient of CANA/CANA group was not assessed at a certain timepoint due to dropout.|||percent change||Standard Deviation|Mean
2563634|NCT02622113|Secondary|Change in Fasting Plasma Glucose||Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks|Full analysis set, last observation carried forward. Outcome measure for two patients of Placebo/CANA group and one patient of CANA/CANA group was not assessed at a certain timepoint due to dropout.|||mg/dL||Standard Deviation|Mean
2563635|NCT02622113|Secondary|Change in Percentage of HbA1c||Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks|Full analysis set, last observation carried forward.|||percentage of HbA1c||Standard Deviation|Mean
2563700|NCT02621060|Secondary|Area Under the Curve of Insulin|Before and after intervention area under the curve of insulin|Week 12.||||pmol/L/min||Standard Deviation|Mean
2566429|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Insulin||Baseline, Week 24|Participants with measurements at given time point.|||µEq/mL||Standard Deviation|Mean
2563639|NCT02622074|Secondary|Overall Survival (OS) Rate at Month 6|OS was defined as the time from the first dose date of study treatment to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The Kaplan-Meier estimates of the percentage of participants who were surviving at Month 6 are presented.|Month 6|The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.|||Percentage of Participants||90% Confidence Interval|Number
2563640|NCT02622074|Secondary|Event-Free Survival (EFS) Rate at Month 24||Month 24||2020-11-30|11/2020||||
2563641|NCT02622074|Secondary|Event-Free Survival (EFS) Rate at Month 12|EFS was defined as the time from the first dose date of study treatment to any of the following events: progression of disease that precludes definitive surgery, disease recurrence (for participants with complete surgical resection), progression (for participants with incomplete surgical resection), or death due to any cause. Participants without documented events were censored at the date of the last disease status assessment. The Kaplan-Meier estimates of the percentage of participants who were event free at Month 12 are presented.|Month 12|The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.|||Percentage of Participants||90% Confidence Interval|Number
2563642|NCT02622074|Secondary|Event-Free Survival (EFS) Rate at Month 6|EFS was defined as the time from the first dose date of study treatment to any of the following events: progression of disease that precludes definitive surgery, disease recurrence (for participants with complete surgical resection), progression (for participants with incomplete surgical resection), or death due to any cause. Participants without documented events were censored at the date of the last disease status assessment. The Kaplan-Meier estimates of the percentage of participants who were event free at Month 6 are presented.|Month 6|The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.|||Percentage of Participants||90% Confidence Interval|Number
2563643|NCT02622074|Secondary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator Review: Second Combination Regimen|ORR was defined as the percentage of participants who achieved a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions) according to RECIST 1.1 by Investigator review. Because imaging was assessed prior to surgery, a confirmation assessment of CR or PR was not obtained. Participants with missing outcome for objective response were considered non-responders. The percentage of participants who experienced a CR or PR based on RECIST 1.1 following the second combination regimen is presented.|After completion of the second combination regimen (KAC; Cycle 9) but prior to surgery (Up to ~9 months); Each cycle was 21 days.|The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.|||Percentage of Participants||90% Confidence Interval|Number
2563644|NCT02622074|Secondary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator Review: First Combination Regimen|ORR was defined as the percentage of participants who achieved a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions) according to RECIST 1.1 by Investigator review. Because imaging was assessed prior to surgery, a confirmation assessment of CR or PR was not obtained. Participants with missing outcome for objective response were considered non-responders. The percentage of participants who experienced a CR or PR based on RECIST 1.1 following the first combination regimen is presented.|At the end of Cycle 5 following treatment with the first combination regimen (KNp , KNpCb or KTCb) (Up to ~4 months); Each cycle was 21 days.|The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.|||Percentage of Participants||90% Confidence Interval|Number
2563645|NCT02622074|Secondary|Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0 (No Invasive Residual in Breast or Nodes; Noninvasive Breast Residuals Allowed)|pCR rate (ypT0/Tis ypN0; no invasive residual in breast or nodes; noninvasive breast residuals allowed) was defined as the rate of absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by AJCC staging criteria assessed by local pathologist at the time of definitive surgery. The percentage of participants with a pCR using the alternative definition of ypT0/Tis ypN0 is presented.|At the time of definitive surgery (Up to approximately 9 months)|The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.|||Percentage of Participants||90% Confidence Interval|Number
2563646|NCT02622074|Secondary|Pathological Complete Response (pCR) Rate Using the Definition of ypT0 ypN0 (No Invasive or Noninvasive Residual in Breast or Nodes)|pCR rate (ypT0 ypN0; no invasive or noninvasive residual in breast or nodes) was defined as the rate of absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by American Joint Committee on Cancer (AJCC) staging criteria assessed by local pathologist at the time of definitive surgery. The percentage of participants with a pCR using the definition of ypT0 ypN0 is presented.|At the time of definitive surgery (Up to approximately 9 months)|The efficacy population consisted of all participants with Baseline evaluable disease by Investigator assessment who started with the recommended Phase 2 dose, regardless of dose modification during the course of the study.|||Percentage of Participants||90% Confidence Interval|Number
2563647|NCT02622074|Primary|Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)|The number of participants who discontinued study treatment due to an AE is presented.|Through database cutoff date of 31-May-2018 (Up to approximately 28 months)|The safety population consisted of all participants who received ≥1 dose of study treatment.|||Participants|||Count of Participants
2563648|NCT02622074|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE either prior to or after definitive surgery is presented.|Through database cutoff date of 31-May-2018 (Up to approximately 28 months)|The safety population consisted of all participants who received ≥1 dose of study treatment.|||Participants|||Count of Participants
2563649|NCT02622074|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) Graded Using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)|"The following events, if considered to be study-treatment-related by the Investigator, were considered a DLT:~Hematologic:~Grade 4 neutropenia lasting ≥8 days;~Febrile neutropenia Grade 3 or Grade 4; or~Grade 4 thrombocytopenia requiring platelet transfusion, or Grade 3 thrombocytopenia with bleeding~Non-hematologic:~Grade 4 toxicity;~Grade ≥3 symptomatic hepatic toxicities lasting >48 hours, or Grade ≥3 asymptomatic hepatic toxicities lasting ≥7 days; or~Grade ≥3 non-hematologic, non-hepatic organ toxicity, with exceptions~Other:~Any treatment delays for ≥14 days due to unresolved toxicity;~Grade 5 treatment-related adverse event (AE);~A dose reduction of study treatment during the DLT evaluation period."|Cycle 1 Day 1 through end of Cycle 3 and Cycle 6 Day 1 through end of Cycle 7 (Up to ~150 days from first dose of first combination regimen); Each cycle was 21 days.|The DLT evaluable population consisted of all participants who received ≥1 dose of study treatment.|||Participants|||Count of Participants
2563650|NCT02621983|Secondary|Change in Scores on the University of California San Diego Performance-Based Skills Assessment (UPSA)|Functional ability will be assessed using the University of California San Diego Performance-Based skills assessment (UPSA). The UPSA is a measure of functional ability to perform common activities of daily living. It assess communication, financial, and household skills as well as the ability to manage medication, navigate transportation, and organize and plan an activity. Each measure creates a raw score which is summed to create a composite score. A higher score indicates better functional ability. No clinically significant thresholds. The maximum score an individual could obtain was 87 and the minimum was 0. The score is reported on scale units.|Baseline, 20 weeks|The numbers will differ from the initial secondary outcome because we had two individuals drop out of the study between the week 12 and week 20 assessments.|||units on a scale||Standard Deviation|Mean
2563651|NCT02621983|Secondary|Change in MCCB Scores|Cognitive function will be assessed by using the MATRICS Consensus Cognitive Battery (MCCB). It assesses seven key cognitive domains: processing speed, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The MCCB is a battery of tests with a computerized scoring system that produces T-scores, adjusted for age and sex, that are used by the MCCB software to create composite scores. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. A higher composite score on the MCCB is indicative of better cognitive function, however there are no clinically significant thresholds. The scores reported below are means +/- standard deviations of these composite scores.|Baseline, 20 weeks|We had significant drop out from baseline measurement to week 20, accounting for the difference in numbers when compared to the total enrolled. We also had two drop out in the Aerobic Exercise group between week 12 and week 20 accounting, which explains the difference in number between the primary outcome and this outcome.|||T-score||Standard Deviation|Mean
2563652|NCT02621983|Secondary|Change in Functional Ability|Functional ability will be assessed using the University of California San Diego Performance-Based skills assessment (UPSA). The UPSA is a measure of functional ability to perform common activities of daily living. It assess communication, financial, and household skills as well as the ability to manage medication, navigate transportation, and organize and plan an activity. Each measure creates a raw score which is summed to create a composite score. A higher score indicates better functional ability. No clinically significant thresholds. The maximum score an individual could obtain was 87 and the minimum was 0. The score is reported on scale units.|Baseline, 12 weeks|We had many individuals who dropped out during the course of the 12 week exercise program, this leads to the discrepancy in number of participants analyzed when compared to those who were randomized into the two arms of the study.|||units on a scale||Standard Deviation|Mean
2563653|NCT02621983|Primary|Change in Cognitive Function, Assessed by Scores on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)|Cognitive function will be assessed by using the MATRICS Consensus Cognitive Battery (MCCB). It assesses seven key cognitive domains: processing speed, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The MCCB is a battery of tests with a computerized scoring system that produces T-scores, adjusted for age and sex, that are used by the MCCB software to create composite scores. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better overall cognitive functioning. A higher composite score on the MCCB is indicative of better cognitive function, however there are no clinically significant thresholds. The scores reported below are means +/- standard deviations of these composite scores.|Baseline, 12 weeks|We had significant drop-out during the course of the 12 week exercise paradigm, therefore only 11 from the Aerobic group and 6 from the Balance and Stretching group completed all 12 weeks worth of exercise.|||T-score||Standard Deviation|Mean
2563654|NCT02621931|Secondary|Participants With Positive Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) Results After the First Dose of Study Drug|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) was used to assess the participant's suicidal ideation (severity and intensity) and behavior (Posner et al 2011). Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.~The eC-SSRS Baseline/Screening version was completed by the participant at baseline, and the eC-SSRS Since Last Visit version was completed by the participant at all other time points. Any positive findings on the eC-SSRS Since Last Visit version required evaluation by a physician or doctoral-level psychologist. Findings after the first dose of study drug using the eC-SSRS Since Last Visit version are summarized."|Baseline (Day 0), Treatment Days 28, 56, 84|Safety population|||Participants|||Count of Participants
2563656|NCT02621931|Secondary|Prothrombin Time Shifts From Baseline to Endpoint|Shifts in prothrombin time from baseline to endpoint were summarized using patient counts grouped into three categories: - Low (below normal range) - Normal (within the normal range of 9.4 to 12.5 seconds) - High (above normal range) Shift format is: baseline finding / endpoint finding|Baseline (Day 0), Treatment Endpoint (Week 12)|Safety population of participants with both baseline and post-treatment values|||Participants|||Count of Participants
2563657|NCT02621931|Secondary|Participants With Urinalysis Laboratory Tests Potentially Clinically Significant Abnormal Results|Urinalysis with potentially clinically significant abnormal findings included: - Blood: >=2 unit increase from baseline - Urine Glucose (mg/dL): >=2 unit increase from baseline - Ketones (mg/dL): >=2 unit increase from baseline - Urine Protein (mg/dL): >=2 unit increase from baseline|Treatment Days 28, 56 and 84 (or endpoint). Changes from previous reading reflect the baseline reading performed on Day 0.|Safety population of participants with at least one post-baseline result for the tests.|||Participants|||Count of Participants
2563658|NCT02621931|Secondary|Participants With Serum Chemistry and Hematology Potentially Clinically Significant Abnormal Results|Serum chemistry and hematology laboratory tests with potentially clinically significant abnormal findings included: - Blood Urea Nitrogen (BUN) High: >=10.71 mmol/L - Creatinine High: >=177 umol/L - Bilirubin High: >=34.2 umol/L - Alanine Aminotransferase (ALT): >=3*upper limit of normal (ULN) - Aspartate Aminotransferase (AST): >=3*upper limit of normal (ULN) - Gamma Glutamyl Transferase (GGT): >=3*upper limit of normal (ULN) - Hemoglobin: Male: <115 g/L or Female: <=95 g/L - Hematocrit: Male: <0.37 L/L or Female: <0.32 L/L - Leukocytes: >=20*10^9/L or <=3*10^9/L - Eosinophils/Leukocytes: >=10% - Platelets: >=700*10^9/L or <=75*10^9/L|Treatment Days 28, 56 and 84 (or endpoint)|Safety population of participants with at least one post-baseline result for the tests|||Participants|||Count of Participants
2563659|NCT02621931|Secondary|Participants With Vital Signs Potentially Clinically Significant Abnormal Values|Vital signs were performed before other assessments (eg, blood draws and administration of questionnaires). Vital signs with potentially clinically significant abnormal findings included: - Pulse Rate High: >=120 and increase of >=15 beats per minute - Pulse Rate Low: <=50 and decrease of >=15 beats per minute - Systolic Blood Pressure Low: <=90 mmHg and decrease of >=20 mmHg - Diastolic Blood Pressure High: >=105 mmHg and increase of >=15 mmHg - Diastolic Blood Pressure Low: <=50 mmHg and decrease of >=15 mmHg - Respiratory Rate Low: <10 breaths / minute|Treatment Days 28, 56 and 84 (or endpoint). Changes from previous reading may reflect the baseline reading performed on Day 0.|Safety population of participants with both baseline and post-treatment values for each vital sign.|||Participants|||Count of Participants
2563660|NCT02621931|Secondary|Electrocardiogram (ECG) Findings Shifts From Baseline to Overall|12-lead ECGs were performed before other assessments (eg, blood draws and administration of questionnaires) and performed in triplicate. The worst post-baseline finding for the participant is summarized. Only participants with both baseline and post-baseline ECGs are included. The ECG was evaluated by the investigator at the time of recording (signed and dated), and the printout was kept in the source documentation file. When potentially clinically significant findings were detected by the investigator, a cardiologist at a central diagnostic center was consulted for a definitive interpretation. Any ECG finding that was judged by the investigator as a potentially clinically significant change (worsening) compared with a baseline value was considered an adverse event. - NCS = abnormal, not clinically significant. - CS= abnormal, clinically significant. Shift format is: baseline finding / worst post-baseline finding.|Baseline (Day 0), Treatment Week 12 (or endpoint)|Safety population of participants with both baseline and post-treatment ECGs.|||Participants|||Count of Participants
2563661|NCT02621931|Secondary|Change From Baseline in Migraine-Related Disability Score, As Measured by the 6-Item Headache Impact Test (HIT) At Week 12|The HIT-6 was developed by Kosinski et al (2003) as a short form for reliably assessing the adverse headache impact in clinical practice and clinical research settings. The questionnaire measures the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning, and psychological distress. It also assesses headache severity. Scores range from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the patient, i.e. scores ≤49 represent little or no impact, scores between 50 and 55 represent some impact, scores between 56 and 59 represent substantial impact; and scores ≥60 indicate severe impact. Negative change from baseline values indicate less adverse impact of headache.|Baseline, 12 weeks|Full analysis set|||units on a scale||Inter-Quartile Range|Median
2563662|NCT02621931|Secondary|Change From Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity During the 12 Week Period After the First Dose of Study Medication in Patients Not Receiving Concomitant Preventive Migraine Medications|A subset of patients (specified in the protocol not to exceed 30%) were allowed to use 1 concomitant migraine preventive medication. This outcome only includes those participants who did not take concomitant preventive migraine medication during this study. Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of >= moderate severity was defined as a calendar day where the patient (using the electronic headache diary device) reports: - a day with headache pain that lasts ≥4 hours with a peak severity of >= moderate severity or - a day when the patient used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. Change is post-baseline value - baseline value.|Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)|FAS of participants who did not receive concomitant preventive migraine medications.|||days||Inter-Quartile Range|Median
2563663|NCT02621931|Secondary|Change From Baseline in the Number of Headache Days of At Least Moderate Severity During the 4 Week Period After the First Dose of Study Drug|Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) where the patient (using the electronic headache diary device) reports: - a day with headache pain that lasts ≥4 hours with a peak severity of at least moderate severity or - a day when the patient used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. The change is calculated as post-baseline value - baseline value.|Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 4)|Full analysis set (FAS) included those in the ITT population who received at least 1 dose of study drug and had at least 10 days of post-baseline efficacy assessments on the primary endpoint.|||days||Standard Error|Least Squares Mean
2563664|NCT02621931|Secondary|Change From Baseline in the Monthly Average Number of Days of Use of Any Acute Headache Medicine During the 12 Week Period After the First Dose of Study Drug|Participants recorded any migraine medications (name of drug, number of tablets/capsules, and the dose in milligrams per tablet/capsule) taken on each day in their electronic headache diary device. Acute migraine-specific medication included triptans or ergots. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The change is calculated as post-baseline value - baseline value.|Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)|Full analysis set|||days||Inter-Quartile Range|Median
2563665|NCT02621931|Secondary|Percentage of Participants With At Least 50% Reduction In Monthly Average Number of Headache Days of At Least Moderate Severity|Responder rates were defined as the percentage of total subjects who reached at least a 50% reduction in the monthly average of headache days (as subjectively reported by participants in the study diary) of at least moderate severity relative to the baseline period. For the overall analysis (Month 1-3), patients who discontinued early were considered non-responders. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The percentage reduction in monthly average is calculated as: ((baseline value - post-baseline value) / baseline value) * 100.|Baseline (Days -28 to Day -1), Treatment: Month 1, Month 2, Month 3, Month 1-3 (Days 1 - Week 12)|FAS. One participant in the Placebo and Fremanezumab 675/225/225 mg treatment arms had 0 headache days of >= moderate severity during baseline and treatment and therefore was not included.|||percentage of total participants|||Number
2563666|NCT02621931|Secondary|Change From Baseline in the Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug|A migraine day was defined as when at least 1 of the following situations occurred: - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for migraine with or without aura - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing - a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds). Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The change is calculated as post-baseline value - baseline value.|Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)|Full analysis set (FAS)|||migraine days / month||Standard Error|Least Squares Mean
2563667|NCT02621931|Primary|Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents usual activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 12|Safety population|||Participants|||Count of Participants
2563668|NCT02621931|Primary|Change From Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity During the 12-Week Period After the First Dose of Study Drug|Headaches were subjectively rated by participants as mild, moderate or severe. A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) where the patient (using the electronic headache diary device) reports: - a day with headache pain that lasts ≥4 hours with a peak severity of at least moderate severity or - a day when the patient used acute migraine-specific medication (triptans or ergots) to treat a headache of any severity or duration. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) * 28. The change is calculated as post-baseline value - baseline value.|Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)|Full analysis set (FAS) included those in the intent to treat (ITT) population who received at least 1 dose of study drug and had at least 10 days of post-baseline efficacy assessments on the primary endpoint.|||days||Inter-Quartile Range|Median
2563669|NCT02621892|Secondary|9 of 12 Week Overall Abdominal Pain Responder Rate|An overall abdominal pain responder is defined as a weekly responder for the first 9/12 weeks. The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.|12 weeks||||Participants|||Count of Participants
2563670|NCT02621892|Secondary|9 of 12 Week Overall CSBM Responder Rate|"An overall CSBM responder is defined as a weekly responder for the first 9/12 weeks. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline and a minimum of at least 3 CSBMs that same week. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds yes to the following question; Did you feel like you completely emptied your bowels?"|12 weeks||||Participants|||Count of Participants
2563671|NCT02621892|Secondary|9 of 12 Week Overall Responder Rate|"An overall responder is defined as a weekly responder for the first 9/12 weeks where both CSBM and abdominal pain response criteria were met for the week. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline and a minimum of at least 3 CSBMs that same week. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds yes to the following question; Did you feel like you completely emptied your bowels? The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline."|12 weeks||||Participants|||Count of Participants
2563672|NCT02621892|Secondary|6 of 12 Week Overall Abdominal Pain Responder Rate|An overall abdominal pain responder is defined as a weekly responder for the first 6/12. The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline.|12 weeks||||Participants|||Count of Participants
2563673|NCT02621892|Secondary|6 of 12 Week Overall Complete Spontaneous Bowel Movement (CSBM)Responder Rate|"An overall CSBM responder is defined as a weekly responder for the first 6/12 weeks. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds yes to the following question; Did you feel like you completely emptied your bowels?"|12 weeks||||Participants|||Count of Participants
2563674|NCT02621892|Primary|6 of 12 Week Overall Responder Rate|"An overall responder is defined as a weekly responder for the first 6/12 weeks where both CSBM and abdominal pain response criteria were met for the week. The CSBM response criteria are defined as an increase of one or more change in average weekly CSBMs from baseline. The definition of a CSBM is as follows: A CSBM is a spontaneous bowel movement (SBM) for which the subject responds yes to the following question; Did you feel like you completely emptied your bowels? The abdominal pain response criterion is defined as a decrease of 30% or more of percent change in average weekly worst abdominal pain from baseline."|12 weeks||||Participants|||Count of Participants
2563675|NCT02621619|Secondary|Change in Pain Intensity Over Time|"Pain intensity is measured on the numerical rating scale from 0 (no pain) to 10 (worst pain imaginable).~Change in pain intensity is calculated by subtracting pain intensity at a later time point from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(15 min)].~Change over time is from baseline to a series of time points: 5 minutes, 15 minutes, 30 minutes, and 45 minutes"|baseline to 5 min, 15 min, 30 min, and 45 minutes||||units on a scale||Standard Deviation|Mean
2563676|NCT02621619|Primary|Change in Pain Intensity, Baseline to 60 Minutes After Medication Infused|"Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable).~Change in pain intensity is calculated by subtracting pain intensity at 60 minutes from pain intensity at baseline [e.g. Change = NRS(baseline) - NRS(60 min)].~Note that a positive change number indicates that pain score decreased after medication was given, while a negative change number indicates that pain score increased after medication was given."|baseline and 60 minutes after medication was infused||||units on a scale||Standard Deviation|Mean
2563677|NCT02621606|Primary|[Part 3] Mean Regional Non-displaceable Binding Potential (BPND) of [11C]MK-6884 in Brain Regions of Interest|"Mean BPND of [11C]MK-6884 in each brain ROI was assessed. BPND is the ratio at equilibrium of specifically bound [11C]MK-6884 to that of non-displaceable [11C]MK-6884 in tissue. At time 0, a single IV bolus of [11]MK-6884 is administered and PET scanning initiated, yielding brain regional TACs. These TACs are then used to determine SUV and AUC in order to quantify brain regional [11C]MK-6884 uptake. The target region BPND is estimated using the cerebellum as the reference region with the TE-TR method. Higher values indicate increased specific [11C]MK-6884 binding in the brain ROI."|Up to 90 minutes post dose|Includes only participants with AD in Part 3 receiving [11C]MK-6884 who sufficiently comply with study protocol (N=10). Per protocol, participants in Part 1 were not tested for mean BPND of [11C]MK-6884 and are excluded. Mean BPND data for Part 2 participants are presented in a separate table.|||Ratio||Standard Deviation|Mean
2563678|NCT02621606|Primary|[Part 2] Intra-subject Test-Retest (T-RT) Variability of Non-displaceable Binding Potential (BPND) of [11C]MK-6884 in Brain Regions of Interest (ROI)|"Intra-subject T-RT variability in BPND of [11C]MK-6884 in each brain ROI was assessed. For each healthy elderly participant receiving 2 doses of [11C]MK-6884 in study Part 2, the BPND calculated during the first dose (BPND-1) was compared to the BPND calculated during the second dose (BPND-2) to determine the percent T-RT variability of the BPND of [11C]MK-6884 for each brain ROI.~Percent T-RT variability = [absolute value (BPND-1 - BPND-2) / (average BPND)] * 100. A percent T-RT variability = 0, indicates no variability between BPND-1 and BPND-2."|Up to 24 hours post dose|Includes only healthy elderly participants in Part 2 receiving 2 doses of [11C]MK-6884 who sufficiently comply with study protocol (N=6). Per protocol, participants in Parts 1 and 3 were not tested for intra-subject T-RT variability of BPND of [11C]MK-6884 and are excluded.|||Percent variability||Standard Deviation|Mean
2563679|NCT02621606|Primary|[Part 2] Mean Non-displaceable Binding Potential (BPND) of [11C]MK-6884 in Brain Regions of Interest (ROI)|"Mean BPND of [11C]MK-6884 in each brain ROI was assessed. BPND is the ratio at equilibrium of specifically bound [11C]MK-6884 to that of non-displaceable [11C]MK-6884 in tissue. At time 0, a single IV bolus of [11]MK-6884 is administered and PET scanning initiated, yielding brain regional TACs. These TACs are then used to determine peak standard uptake value (SUV) and area under the curve (AUC) in order to quantify brain regional [11C]MK-6884 uptake. The target region BPND is estimated using the cerebellum as the reference region with the transient equilibrium tissue ratio (TE-TR) method. Higher values indicate increased specific [11C]MK-6884 binding in the brain ROI."|Up to 90 minutes post dose|Includes only healthy elderly participants in Part 2 receiving 2 doses of [11C]MK-6884 who sufficiently comply with study protocol (N=6). Per protocol, participants in Part 1 were not tested for mean BPND of [11C]MK-6884 and are excluded. Mean BPND data for Part 3 participants are presented in a separate table.|||Ratio||Standard Deviation|Mean
2563680|NCT02621606|Primary|[Part 1] Mean Organ Effective Dose of [11C]MK-6884|Mean organ ED of [11C]MK-6884 was calculated as a measure of risk associated with exposure of individual organs to low levels of ionizing radiation. Following [11C]MK-6884 injection, WB PET scans were collected to visually identify organs absorbing [11C]MK-6884 in significant amounts. Around identified organs, 3D volumes were drawn to estimate the percentage of injected activity absorbed. These data were converted into TACs and retention of radioactivity in these regions was used to calculate organ-specific ED of [11C]MK-6884. For sex organs (testes/ovaries), organ EDs were derived for participants of the respective sex. However, organ ED for the uterus was estimable in all participants as the male radiologic phantom was sufficiently hermaphroditic.|Up to 2 hours post dose|Includes only healthy participants in Part 1 (N=3), having estimable data for the individual organ. Per protocol, participants in Parts 2 and 3 were not tested for organ ED of [11C]MK-6884 and are excluded.|||mSv / MBq||Standard Deviation|Mean
2563701|NCT02621060|Secondary|Area Under the Curve of Glucose|Area under the curve of glucose was obtained using the trapezoidal integration.|Week 12.|3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.|||mmol/l/min||Standard Deviation|Mean
2563702|NCT02621060|Primary|Insulin Sensitivity|After intervention Matsuda Index|Week 12.|3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.|||Unitless||Standard Deviation|Mean
2563703|NCT02621060|Primary|First Phase of Insulin Secretion|After intervention with Stumvoll index|Week 12.|3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.|||Unitless||Standard Deviation|Mean
2563681|NCT02621606|Primary|[Part 1] Mean Effective Dose of [11C]MK-6884|Mean effective dose (ED) of [11C]MK-6884 was calculated as a measure of risk associated with exposure of the whole body (WB) to low levels of ionizing radiation. Following [11C]MK-6884 injection, WB positron emission tomography (PET) scans were collected to visually identify organs absorbing [11C]MK-6884 in significant amounts. Around identified organs, three-dimensional (3D) volumes were drawn to estimate the percentage of injected activity absorbed. These data were converted into time-activity curves (TACs) and retention of radioactivity in these regions was entered into a human biodistribution model to determine ED of [11C]MK-6884. ED is expressed in units millisieverts (mSv) / MBq.|Up to 2 hours post-dose|Includes only healthy participants in Part 1 (N=3). Per protocol, participants in Parts 2 and 3 were not tested for ED of [11C]MK-6884 and are excluded.|||mSv / MBq||Standard Deviation|Mean
2563682|NCT02621606|Primary|Number of Participants Discontinuing the Study Due to an Adverse Event (AE)|The number of participants discontinuing the study due to an AE was assessed. An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE.|Up to 15 days|Includes all participants receiving ≥1 dose of [11C]MK-6884 in Parts 1, 2, or 3.|||Participants|||Count of Participants
2563683|NCT02621606|Primary|Number of Participants Experiencing an Adverse Event (AE)|The number of participants experiencing an adverse event (AE) was assessed. An AE is defined as any unfavorable and unintended medical occurrence, sign, symptom, or disease temporally associated with the use of a pharmaceutical product or protocol-specified procedure, whether or not considered related to the pharmaceutical product or protocol-specified procedure. Any worsening of a preexisting condition, temporally associated with the use of the Sponsor's product, is also an AE.|Up to 15 days|Includes all participants receiving ≥1 dose of [11C]MK-6884 in Parts 1, 2, or 3.|||Participants|||Count of Participants
2563684|NCT02621073|Secondary|Number of Operative Debridements Until Wound Healed||12 months||||Operations||Full Range|Mean
2563685|NCT02621073|Primary|Bacterial Load|Semiquantitative wound culture(s) done at each debridement procedure, (up to 3). Organism quantities are listed as scant, moderate, or heavy. Report includes identification of organism, and susceptibility. Wound cultures will be analyzed and reported by the University of Missouri Hospital Laboratory.|approximately 4 weeks||||Participants|||Count of Participants
2563686|NCT02621060|Secondary|Uric Acid|The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinina levels at week 12.|Week 12.|3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.|||mmol/l||Standard Deviation|Mean
2563687|NCT02621060|Secondary|Creatinine|The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12|Week 12.||||mmol/L||Standard Deviation|Mean
2563688|NCT02621060|Secondary|Glutamic Oxaloacetic Transaminase (GOT)|Before and after intervention by spectrophotometry|Week 12.|3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.|||IU/L||Standard Deviation|Mean
2563689|NCT02621060|Secondary|Glutamic Pyruvic Transaminase (GPT)|Before and after intervention by spectrophotometry|Week 12.|3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.|||IU/L||Standard Deviation|Mean
2563690|NCT02621060|Secondary|Very-low Density Lipoprotein (VLDL)|The VLDL levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12|Week 12.|3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.|||mmol/L||Standard Deviation|Mean
2563691|NCT02621060|Secondary|Low-density Lipoprotein Cholesterol (LDL-C)|The LDL-C levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the LDL-C levels at week 12|Week 12.|3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.|||mmol/L||Standard Deviation|Mean
2563692|NCT02621060|Secondary|High-density Lipoprotein Cholesterol (HDL-C)|The HDL-C levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the HDL-C level at week 12|Week 12.|3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.|||mmol/L||Standard Deviation|Mean
2563693|NCT02621060|Secondary|Total Cholesterol (TC)|The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12|Week 12.|3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.|||mmol/L||Standard Deviation|Mean
2563694|NCT02621060|Secondary|Triglycerides (TG)|The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12|Week 12.|3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.|||mmol/L||Standard Deviation|Mean
2563695|NCT02621060|Secondary|Diastolic Blood Plessure (DBP)|The Diastolic blood plessure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12|Week 12.|3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.|||mmHg||Standard Deviation|Mean
2563696|NCT02621060|Secondary|Systolic Blood Pressure (SBP)|The Systolic Blood Pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12|Week 12.|3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.|||mmHg||Standard Deviation|Mean
2563697|NCT02621060|Secondary|Waist Circumference (WC)|Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflects the waist circumference measure at week 12|Week 12.|3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.|||cm||Standard Deviation|Mean
2563698|NCT02621060|Secondary|Body Mass Index|The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12|Week 12.||||kg/m^2||Standard Deviation|Mean
2563699|NCT02621060|Secondary|Body Weight|The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12|Week 12.|3 and 1 subjects dropout in the placebo and chlorogenic acid group respectively.|||kg||Standard Deviation|Mean
2563708|NCT02621047|Secondary|Fraction of Drug Unbound (fu) of Total Alectinib|Total alectinib = unbound alectinib plus alectinib bound to plasma proteins. fu = ratio of unbound alectinib to total alectinib multiplied by 100.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||percentage of total alectinib||Geometric Coefficient of Variation|Geometric Mean
2563709|NCT02621047|Secondary|Vz/F for Unbound Alectinib|Volume of distribution is defined as the theoretical volume which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the fraction absorbed.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||liters||Geometric Coefficient of Variation|Geometric Mean
2563710|NCT02621047|Secondary|Apparent Volume of Distribution (Vz/F) for Total Alectinib|Total alectinib = unbound alectinib plus alectinib bound to plasma proteins. Volume of distribution is defined as the theoretical volume which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the fraction absorbed.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||liters||Geometric Coefficient of Variation|Geometric Mean
2563711|NCT02621047|Secondary|CL/F of Unbound Alectinib|Clearance is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||liters per hour||Geometric Coefficient of Variation|Geometric Mean
2563712|NCT02621047|Secondary|Apparent Oral Clearance (CL/F) of Total Alectinib|Total alectinib = unbound alectinib plus alectinib bound to plasma proteins. Clearance is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||liters per hour||Geometric Coefficient of Variation|Geometric Mean
2563713|NCT02621047|Secondary|t1/2 of Total M4|Total M4 = unbound M4 plus M4 bound to plasma proteins. t1/2 = the time measured for the plasma concentration to decrease by one half.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hours||Geometric Coefficient of Variation|Geometric Mean
2563714|NCT02621047|Secondary|Apparent Terminal Half-life (t1/2) of Total Alectinib|Total alectinib = unbound alectinib plus alectinib bound to plasma proteins. t1/2 = the time measured for the plasma concentration to decrease by one half.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hours||Geometric Coefficient of Variation|Geometric Mean
2563715|NCT02621047|Secondary|Tmax for Total M4|Total M4 = unbound M4 plus M4 bound to plasma proteins|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hours||Full Range|Median
2563716|NCT02621047|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Total Alectinib|Total alectinib = unbound alectinib plus alectinib bound to plasma proteins|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hours||Full Range|Median
2563717|NCT02621047|Secondary|AUC 0-last of Unbound Alectinib + M4||Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2563718|NCT02621047|Secondary|AUC 0-last of Total Alectinib + M4|Total alectinib + M4 = unbound alectinib + M4 plus alectinib + M4 bound to plasma proteins|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2563719|NCT02621047|Secondary|AUC 0-last of Unbound M4||Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563720|NCT02621047|Secondary|AUC 0-last of Total M4|Total M4 = unbound M4 plus M4 bound to plasma proteins|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563721|NCT02621047|Secondary|AUC 0-inf of Unbound Alectinib + M4|AUC 0-inf = AUC from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC 0-t plus AUC t-inf.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2563722|NCT02621047|Secondary|AUC 0-inf of Total Alectinib + M4|Total alectinib + M4 = unbound alectinib + M4 plus alectinib + M4 bound to plasma proteins. AUC 0-inf = AUC from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC 0-t plus AUC t-inf.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2563723|NCT02621047|Secondary|AUC 0-inf of Unbound M4|AUC 0-inf = AUC from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC 0-t plus AUC t-inf.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563796|NCT02618928|Secondary|Number of Participants With Hospitalizations Due to Liver Disease by Category||From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.|Core population with available data|||Participants|||Count of Participants
2563724|NCT02621047|Secondary|AUC 0-inf of Total M4|Total M4 = unbound M4 plus M4 bound to plasma proteins. AUC 0-inf = AUC from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC 0-t plus AUC t-inf.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563725|NCT02621047|Secondary|Cmax of Unbound Alectinib + M4||Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2563726|NCT02621047|Secondary|Cmax of Total Combined Alectinib and M4 (Alectinib + M4)|Total alectinib + M4 = unbound alectinib + M4 plus alectinib + M4 bound to plasma proteins|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||nanomoles per liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2563727|NCT02621047|Secondary|Cmax of Unbound M4||Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563728|NCT02621047|Secondary|Cmax of Total Metabolite of Alectinib (M4)|Total M4 = unbound M4 plus M4 bound to plasma proteins|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563729|NCT02621047|Primary|AUC 0-last for Unbound Alectinib||Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563730|NCT02621047|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measureable Concentration (AUC 0-last) for Total Alectinib|Total alectinib = unbound alectinib plus alectinib bound to plasma proteins|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563731|NCT02621047|Primary|AUC 0-inf for Unbound Alectinib|AUC 0-inf = AUC from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC 0-t plus AUC t-inf.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563732|NCT02621047|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC 0-inf) for Total Alectinib|Total alectinib = unbound alectinib plus alectinib bound to plasma proteins. AUC 0-inf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC 0-t plus AUC t-inf.|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563733|NCT02621047|Primary|Cmax of Unbound Alectinib||Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2563734|NCT02621047|Primary|Maximum Observed Plasma Concentration (Cmax) of Total Alectinib|Total alectinib = unbound alectinib plus alectinib bound to plasma proteins|Predose (0 hour), and at 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose (Dosing day = Day 1)|Pharmacokinetic population included all participants who were enrolled in the study, received study treatment, and had pharmacokinetic data available.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2563735|NCT02621034|Primary|Comparison of Post-operative Pain Between the Three Groups at the 72-hour Interval||72 hours||||units on a scale||Standard Deviation|Mean
2563736|NCT02621034|Primary|Comparison of Post-operative Pain in the Reciproc and Oneshape Groups Through Out the Intervals||72 hours||||units on a scale||Standard Deviation|Mean
2563737|NCT02621034|Primary|Post-operative Pain on the Visual Anlogue Scale (VAS) at the 6-hour Post-operative Interval|"The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, For pain intensity, the scale is most commonly anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10)."|6 hours||||units on a scale||Standard Deviation|Mean
2563738|NCT02620917|Secondary|Number of Patients With HbA1c on Target Using Advanced Pump's Functions, CGM and CHO Counting|number of patients adults with HbA1c <7,0% using advanced pump's functions, CGM and CHO counting number of paediatrics patients with HbA1c < 7.5% using advanced pump's functions, CGM and CHO counting|1 year||||participants|||Number
2563739|NCT02620917|Primary|Number of Patients With Glycated Hemoglobin on Target|number of patients who achieved HbA1c target (< 7,5% in patients < 18 years old; <7% in adult patients);|1 year||||participants|||Number
2563740|NCT02620917|Primary|Patients With Severe Hypoglycemia|Number of patients reporting severe hypoglycemia (requiring assistance by an other person) in the last year|1year||||participants|||Number
2563741|NCT02620917|Primary|Efficacy Assessed by Median of HbA1c,|median of HbA1c measured in the last year|1 year||||mmol/mol||Inter-Quartile Range|Median
2563742|NCT02620878|Secondary|Percentage of Time Artificial Pancreas is Active|percentage of time that the system worked without any technical problem|3 days||||percentage of time||Inter-Quartile Range|Mean
2563743|NCT02620878|Primary|Percentage of Time Spent in Target Range (70-180 mg/dl or 3.9-10.0 mmol/L)|"percentage of time spent in target range (70-180 mg/dl or 3.9-10.0 mmol/L) both during day and night.~All analyses will include a comparison of the results in Artificial pancraes and SAP period"|3 days||||percentage||Standard Deviation|Mean
2563744|NCT02620878|Primary|Percentage of Time Spent With Blood Glucose < 3.9 mmol/L (or 70 mg/dl)|"percentage of time spent in hypoglicemia (< 70 mg/dl or 3.9 mmol/L) both during day and night.~All analyses will include a comparison of the results in Artificial Pancreas and SAP period"|3 days||||percentage||Inter-Quartile Range|Mean
2566430|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: HDL||Baseline, Week 48|Participants with measurements at given time point.|||mmol/L||Standard Deviation|Mean
2563746|NCT02620787|Secondary|Tedizolid Area Under the Curve (AUC) in Tissue|"The area under the drug concentration-time curve (AUC) in tissue reflects the actual tissue exposure to drug after administration of a dose of the drug and is expressed in mg*h/L.~Venous blood was obtained via peripheral intravenous catheter at 48 hours from the start of the first dose (i.e., immediately before administration of the 3rd dose), and at 49, 50, 50.5, 51, 51.5, 52, 54, 56, 60, 64 and 72 hours.~Dialysate samples of 120μL were collected in 200µL microvials simultaneously with plasma at 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 64, 68 and 72 hours following administration of the first dose."|48-72 hours|One volunteer and one patient participant were excluded due to low concentrations|||mg*h/L||Standard Deviation|Mean
2563747|NCT02620787|Primary|Tedizolid Tissue Penetration|The ratio of tedizolid tissue concentrations to blood concentrations following the final tedizolid dose|48-72 hours|One volunteer and one patient participant were excluded due to low concentrations|||ratio||Standard Deviation|Mean
2563748|NCT02620774|Secondary|Number of Participants With Adverse Events|Number of reported or documented adverse events recorded during participation in the study.|Duration of study (34 hours)||||Participants|||Count of Participants
2563749|NCT02620774|Secondary|Tazobactam Total Drug AUC in Plasma|"The tazobactam total drug AUC in plasma over 16 to 24 hours~Note. Ceftolozane/tazobactam doses were administered at 0, 8, and 16 hours. Plasma concentrations were determined at hours 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours after the first dose for determination of tazobactam AUC."|16 to 24 hours post-dose|Seven of the 10 enrolled participants in the Diabetic Wound Infection cohort provided data for tazobactam in plasma. Assay interference was observed in samples for two participants, and one participant had concentrations below the lower limit of the detection for the assay. This explains the difference with participant flow numbers.|||µg•h/mL||Full Range|Median
2563750|NCT02620774|Secondary|Ceftolozane Total Drug AUC in Plasma|"The ceftolozane total drug AUC in plasma over 16 to 24 hours~Note. Ceftolozane/tazobactam doses were administered at 0, 8, and 16 hours. Plasma concentrations were determined at hours 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours after the first dose for determination of ceftolozane AUC."|16 to 24 hours post-dose||||µg•h/mL||Full Range|Median
2563751|NCT02620774|Secondary|Tazobactam AUC in Tissue|"The tazobactam AUC in tissue over 16 to 24 hours~Note. Ceftolozane/tazobactam doses were administered at 0, 8, and 16 hours. Dialysate concentrations were determined at hours 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours after the first dose for determination of tazobactam AUC."|16 to 24 hours post-dose||||µg•h/mL||Full Range|Median
2563752|NCT02620774|Secondary|Ceftolozane Area Under the Curve (AUC) in Tissue|"The ceftolozane AUC in tissue from 16 to 24 hours.~Note. Ceftolozane/tazobactam doses were administered at 0, 8, and 16 hours. Dialysate concentrations were determined at hours 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours after the first dose for determination of ceftolozane AUC."|16 to 24 hours post-dose||||µg•h/mL||Full Range|Median
2563753|NCT02620774|Primary|Tazobactam Tissue Penetration|"The ratio of tazobactam tissue concentration area under the curve (AUC) to plasma concentration AUC following the final (3rd) ceftolozane/tazobactam dose.~Note. Ceftolozane/tazobactam doses were administered at 0, 8, and 16 hours. Plasma and dialysate concentrations were determined at hours 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours after the first dose for determination of tazobactam AUC in blood and tissue."|16-24 hours|Seven of the 10 enrolled participants in the Diabetic Wound Infection cohort provided data for tazobactam in plasma. Assay interference was observed in samples for two participants, and one participant had concentrations below the lower limit of the detection for the assay. This explains the difference with participant flow numbers.|||ratio||Full Range|Median
2563754|NCT02620774|Primary|Ceftolozane Tissue Penetration|"The ratio of ceftolozane tissue concentration area under the curve (AUC) to plasma concentrations AUC following the final (i.e., 3rd) ceftolozane/tazobactam dose.~Note. Ceftolozane/tazobactam doses were administered at 0, 8, and 16 hours. Plasma and dialysate concentrations were determined at hours 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours after the first dose for determination of ceftolozane AUC in blood and tissue."|16-24 hours||||ratio||Full Range|Median
2563755|NCT02620683|Secondary|Topical Anesthesia Effect Contralateral Lower Lip|"Investigator will administer 5-6 drops of the lidocaine to the contralateral lower lip and immediately ask if signs of numbness are present on the lip.~Patients reported presence of numbness lower lip-Yes or No"|At time of administration|Unable to administer in this fashion because Lidocaine would not remain on lip surface therefore data were not collected||||||
2563756|NCT02620683|Secondary|Number of Minutes to Anesthesia Symptoms of Lower Lip|"Patients were instructed to record the time when they experienced the initial indication of anesthesia signs in the lower lip. This was reported as the number of minutes following nerve block injection.~For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered was performed."|Patient report of anesthesia symptom onset following injection||||minutes||Standard Deviation|Mean
2563757|NCT02620683|Secondary|Pain Intensity Scores|"Patients reported pain level immediately after injection of lidocaine via a Likert type scale where 1 = No Pain and 10 = Worst Pain Imaginable.~For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered was performed."|Immediately after lidocaine injection||||units on a scale||Standard Deviation|Mean
2563758|NCT02620683|Primary|Lidocaine Blood Levels 30 Minutes Post Injection|Lidocaine blood levels were obtained 30 minutes post injection micro g/L The difference between injection type- 95% confidence intervals for the difference between injection types was calculated. For the outcome variable, an assessment of treatment difference by subject, calculated as 1% Buffered minus 2% Non-Buffered, was performed using Wilcoxon rank sum tests with Proc NPAR1WAY (SAS v 9.3). Statistical significance was set as P < 0.05 for all outcomes.|30 minutes post injection||||ug/L||Standard Deviation|Mean
2563759|NCT02620384|Other Pre-specified|Number of Participants With Magnesium Electrolyte Abnormality Requiring Replacement|Number of Participants with severe electrolyte abnormalities requiring aggressive replacement defined as magnesium levels less than 1.5 meq/L during the study.|48 Hours|All participants who received both doses of the investigational product and completed the 48 hour assessments were included in the efficacy analysis.|||Participants|||Count of Participants
2563797|NCT02618928|Secondary|Number of Participants With Outpatient Consultations Due to Liver Disease by Category||From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.|Core population with available data|||Participants|||Count of Participants
2563760|NCT02620384|Other Pre-specified|Number of Participants With Potassium Electrolyte Abnormality Requiring Replacement|Severe electrolyte abnormalities requiring aggressive replacement defined as potassium levels less than 3.0 meq/L during the study.|48 Hours|All participants who received both doses of the investigational product and completed the 48 hour assessments were included in the efficacy analysis.|||Participants|||Count of Participants
2563761|NCT02620384|Other Pre-specified|Heart Failure Readmission Within 30 Days|Heart Failure Readmission Within 30 Days|30 Days|All participants who received both doses of the investigational product and completed the 48 hour assessments were included in the efficacy analysis.|||Participants|||Count of Participants
2563762|NCT02620384|Other Pre-specified|All Cause Readmission Within 30 Days|All Cause Readmission Within 30 Days|30 Days|All participants who received both doses of the investigational product and completed the 48 hour assessments were included in the efficacy analysis.|||Participants|||Count of Participants
2563763|NCT02620384|Other Pre-specified|Length of Hospital Stay|Length of hospital stay in days|Inpatient Hospitalization|All participants who received both doses of the investigational product and completed the 48 hour assessments were included in the efficacy analysis.|||days||Standard Deviation|Mean
2563764|NCT02620384|Secondary|All Cause Mortality at 30 Days|All Cause Mortality at 30 Days|30 Days|All participants who received both doses of the investigational product and completed the 48 hour assessments were included in the efficacy analysis.|||Participants|||Count of Participants
2563765|NCT02620384|Secondary|Number of Participants With Inotrope Administration During First 48 Hours|Number of Participants with Inotrope administration during first 48 hours following study enrollment.|48 hours|All participants who received both doses of the investigational product and completed the 48 hour assessments were included in the efficacy analysis.|||Participants|||Count of Participants
2563766|NCT02620384|Secondary|Total Dose Diuretics First 48 Hours|Total dosage loop diuretic in first 48 hours using conversion tool to calculate intravenous Lasix equivalence|48 hours|All participants who received both doses of the investigational product and completed the 48 hour assessments were included in the efficacy analysis.|||Milligrams||Standard Deviation|Mean
2563767|NCT02620384|Secondary|Degree of Improvement in Dyspnea at 6, 12, 24, 36 and 48 Hours.|Dyspnea assessed at 6, 12, 24, 36 and 48 hours with Modified Borg Scale (1-10). Range is from 1 (very slight) to 10 (maximal) dyspnea.|6, 12, 24, 36 and 48 hours.|All participants who received both doses of the investigational product and completed the 48 hour assessments were included in the efficacy analysis.|||score on a scale||Standard Deviation|Mean
2563768|NCT02620384|Secondary|Change in Weight First 48 Hours|Change in weight from the date/time of study enrollment (baseline) and 48 hours.|48 hours|All participants who received both doses of the investigational product and completed the 48 hour assessments were included in the efficacy analysis.|||killograms||Standard Deviation|Mean
2563769|NCT02620384|Primary|Fluid Balance at 48 Hours|Difference in value between input and output in milliliters (ml) at 48 hours. Measurement timing began with administration of first dose of investigational product, ended 48 hours later. Fluid balance = Fluid in minus Fluid out.|48 hours|All participants who received both doses of the investigational product and completed the 48 hour assessments were included in the efficacy analysis.|||Mililiters||Standard Deviation|Mean
2563770|NCT02620384|Primary|Total Urinary Output at 48 Hours|Total urinary output in milliliters (ml) at 48 hours. Measurement timing began with administration of first dose of investigational product, ended 48 hours later.|48 hours|All participants who received both doses of the investigational product and completed the 48 hour assessments were included in the efficacy analysis.|||Milliliters||Standard Deviation|Mean
2563771|NCT02620020|Secondary|Change From Baseline to Week 16 in the Patient Global Assessment (PGA) of Low Back Pain (LBP) Score|The PGA of LBP is a participant assessed 5 point Likert scale of LBP ranging from 0-5 where 1=very well; 2=well; 3=fair; 4=poor; and 5=very poor.|Baseline to Week 16|Analysis was performed on mITT population. Here, number of participants analyzed=participants with available data for specified time point.|||Units on a scale||Standard Error|Least Squares Mean
2563772|NCT02620020|Secondary|Change From Baseline to Week 16 in Roland Morris Disability Questionnaire (RMDQ) Total Score|The RMDQ is a self-administered, widely used health status measure for lower back pain (LBP). It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The score of the RMDQ is the total number of items checked - that is from a minimum of 0 (no disability) to a maximum of 24 (maximum disability), where lower scores indicative of better function.|Baseline to Week 16|Analysis was performed on mITT population. Here, number of participants analyzed = participants with available data for specified time point.|||Units on a scale||Standard Error|Least Squares Mean
2563773|NCT02620020|Secondary|Change From Baseline to Weeks 2, 4, 8, and 12 in the Average Low Back Pain Index Numeric Rating Scale Score (LBPI NRS)|Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.|Baseline to Weeks 2, 4, 8, and 12|Analysis performed on modified intent to treat set (mITT) included all randomized participants who received at least one dose of study drug based on the treatment allocated (as randomized) including data up to 5 weeks after the last dose of study drug. Number of participants analyzed = participants with available data for specified time point.|||Scores on a scale||Standard Error|Least Squares Mean
2563774|NCT02620020|Primary|Change From Baseline to Week 16 in the Average Daily Low Back Pain Index Numeric Rating Scale (LBPI NRS) Score|Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.|Baseline to Week 16|Analysis performed on modified intent to treat set (mITT) included all randomized participants who received at least one dose of study drug based on the treatment allocated (as randomized) including data up to 5 weeks after the last dose of study drug. Number of participants analyzed = participants with available data for specified time point.|||Scores on a scale||Standard Error|Least Squares Mean
2563775|NCT02619812|Primary|Stool Consistency|"The subjects rated their stool consistency using the Bristol Stool Scale. The Bristol Stool Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|30 days|Data were not collected.||||||
2563776|NCT02619812|Primary|Stool Frequency|Stool frequency was self reported in a daily bowel pattern diary for 30 days.|30 days|Data were not collected.||||||
2563777|NCT02619799|Secondary|Perioperative Side Effects|through out the intraoperative period and initial 12 hours postoperatively parturients were assessed for PONV,sedation,respiratory depression hypotension ,bradycardia and shivering.|through out the intraoperative period and first 12 postoperative hours.||||participants|||Number
2563778|NCT02619799|Secondary|Duration of Motor Blockade|assessed with modified bromage scale.|every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery.||||time in minutes||Standard Deviation|Mean
2563779|NCT02619799|Secondary|Onset of Motor Blockade|assessed with modified bromage scale.|every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery.||||time in minutes||Standard Deviation|Mean
2563780|NCT02619799|Secondary|Duration of Sensory Blockade|the duration of sensory blockade was assessed with pinprick .|every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery..||||time in minutes||Standard Deviation|Mean
2563781|NCT02619799|Secondary|Onset of Sensory Blockade|the onset time of sensory blockade was assessed with pinprick .|every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery..||||time in minutes||Standard Deviation|Mean
2563782|NCT02619799|Primary|Duration of Postoperative Analgesia|pain is assessed using visual analogue scale every hour after completion of surgery until first 12 postoperative hours.|first 12 hours after completion of surgery.||||time in minutes||Standard Deviation|Mean
2563783|NCT02619617|Secondary|Pulse Rate|Vital signs by treatment and time point|screening and end of study, up to 9 days after treatment|Safety analysis set|||Beats/min||Standard Deviation|Mean
2563784|NCT02619617|Secondary|Change in Hemoglobin Values From Screening to End of Study|Change in hemoglobin values from screening and end of study|screening and end of study, up to 9 days after treatment|Safety analysis set|||g/L||Standard Deviation|Mean
2563785|NCT02619617|Secondary|Number of Participants Who Were Pain Free at 30 Minutes Post Dose|Participants who were pain free 30 minutes after dosing and reporting improvement of associated autonomic symptoms (for example, lacrimation, blushing, pupil constriction, etc.) over time was tabulated by dose.|30 mins post dose|PD analysis set)|||participants|||Number
2563786|NCT02619617|Primary|Number of Participants With Headache Response (PD Analysis Set)|Defined as very severe, severe, or moderate pain before dosing that becomes mild or nil at 30 minutes post-dosing|30 minutes post dose|PD analysis set: Subjects with protocol deviations which impacted PD data were excluded from the PD analysis|||participants|||Number
2563787|NCT02619591|Primary|Pneumothorax (Positive or Negative)|The presence of a pneumothorax at the time of the ultrasound|up to 20 minutes||||participants|||Number
2563788|NCT02619409|Primary|Duration of Motor Block|(hip felxion) of the non operative leg|12 hours||||hours||Standard Deviation|Mean
2563789|NCT02619409|Primary|Duration of Sensory Block|Duration of the sensory block at the T12 dermatome will be assessed in the post operative phase|12 hours||||hours||Standard Deviation|Mean
2563790|NCT02619175|Secondary|Change in Activities-specific Balance Confidence (ABC) Scale|A self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. Score on a scale (0-100). Higher values represent a better outcome.|1-3 days before the first session of intervention and 1-3 days after the last session of intervention.||||score on a scale||Standard Deviation|Mean
2563791|NCT02619175|Secondary|Change in Fall Threshold|The perturbation level at which the subject lost balance and fell into the safety harness. Score on a scale (1-7). Each unit represents the perturbation intensity where the subject was unable to recover balance and fell into harness system. Higher values represent a better outcome.|1-3 days before the first session of intervention and 1-3 days after the last session of intervention.||||score on a scale||Standard Deviation|Mean
2563792|NCT02619175|Secondary|Change in Berg Balance Scale Score|"A 14-item objective measure (ordinal scale) designed to assess static balance and fall risk.~Minimus score =0, Maximal score=56. Higher values represent a better outcome."|1-3 days before the first session of intervention and 1-3 days after the last session of intervention.||||units on a scale 0-56.||Standard Deviation|Mean
2563793|NCT02619175|Primary|Change in Compensatory Step Velocity|"will be calculated from step length and step swing time data, using a 3D motion analysis system.~Step velocity in response to surface translations toward the non-paretic side."|1-3 days before the first session of intervention and 1-3 days after the last session of intervention.|Analysis was conducted for step responses at perturbation level 3, since step responses were not frequently induced at low perturbation intensities and most subjects were not able to recover balance loss at higher perturbation intensities. Data represent subjects who reached intensity 3 without a fall in previous intensities (n=13 and n=8).|||m/sec||Standard Deviation|Mean
2563794|NCT02619175|Primary|Change in Compensatory Step Execution Time|"Will be calculated as the time from platform perturbation to foot contact using a 3D motion analysis system.~Step execution time in response to surface translations toward the non-paretic side."|1-5 days before the first session of intervention and 1-5 days after the last session of intervention.|Analysis was conducted for step responses at perturbation level 3, since step responses were not frequently induced at low perturbation intensities and most subjects were not able to recover balance loss at higher perturbation intensities. Data represent subjects who reached intensity 3 without a fall in previous intensities (n=13 and n=8).|||msec||Standard Deviation|Mean
2563795|NCT02618928|Secondary|Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)||Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)|Treated participants with available data at baseline and end of treatment.|||percent glycosylated hemoglobin||Standard Deviation|Mean
2566431|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: HDL||Baseline, Week 24|Participants with measurements at given time point.|||mmol/L||Standard Deviation|Mean
2563798|NCT02618928|Secondary|Change From Baseline in Patient Activation Measure 13 (PAM-13)|"PAM 13 is a measure used to assess the patient knowledge, skill, and confidence for self-management, consisting of 13 questions. Each of the 13 items can be answered with one of four possible response options, which are disagree strongly (1), disagree (2), agree (3), agree strongly (4). Scores were summed to calculate the overall raw score, then transformed to a scale with a theoretical range 0 to 100, based on calibration tables, with higher PAM scores indicating higher patient activation."|Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)|The Core population with available data at baseline and end of treatment.|||units on a scale||Standard Deviation|Mean
2563799|NCT02618928|Secondary|Change From Baseline in Beliefs Medication Questionnaire - (18-item BMQ)|The BMQ consists of 2 sections and 18 questions to screen for patients' beliefs, attitudes and concerns about their medication. The BMQ-Specific section comprises two 5-item subscales assessing the necessity of and concerns about the prescribed medication (Specific-Necessity and Specific-Concerns). The BMQ-General section comprises two 4-item subscales assessing beliefs that medicines are harmful and overused by doctors in general (General-Harm and General-Overuse). The 18 items are rated on a Likert scale from 1 (strongly disagree) to 5 (strongly agree). Each subscale score ranges from 1 to 5. High scores in the Specific-Concerns scale represent the notion that adverse reactions are potentially harmful when taking medication on a regular basis, and high scores in the Specific-Necessity scale indicate the patient's need to adhere to medication to maintain health. High scores in the General-Harm and General-Overuse scales represent an overall negative perception of medication.|Baseline and end of treatment (week 8, 12, or 24 depending on the treatment regimen)|The Core population with available data at baseline and end of treatment.|||units on a scale||Standard Deviation|Mean
2563800|NCT02618928|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Activity Impairment|"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total activity impairment (TAI) indicates the percentage of general (non-work) activity impairment due to health problems."|Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|The Core population with available data at baseline and each time point.|||percent impairment||Standard Deviation|Mean
2563801|NCT02618928|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Total Work Productivity Impairment (TWP)|"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total work productivity impairment (TWP) indicates the percentage of overall work impairment due to health problems."|Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|The Core population who were employed and with available data at baseline and each time point.|||percent impairment||Standard Deviation|Mean
2563802|NCT02618928|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Presenteeism|"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Presenteeism indicates the percentage of impairment while working due to health problems."|Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|The Core population who were employed and with available data at baseline and each time point.|||percent impairment||Standard Deviation|Mean
2563803|NCT02618928|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Absenteeism|"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Absenteeism indicates the percentage of work time missed due to health problems."|Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|The Core population who were employed and with available data at baseline and each time point.|||percent impairment||Standard Deviation|Mean
2563804|NCT02618928|Secondary|Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) VAS Score|"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status with a separate visual analog scale (VAS).~The VAS assesses overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable)."|Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|Core population with available data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
2563805|NCT02618928|Secondary|Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score|"The EQ-5D-5L is a health state utility instrument that evaluates preference for health status. The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which are rated on 5 levels of severity (1: indicating no problem, 2: indicating slight problems, 3: indicating moderate problems, 4: indicating severe problems, 5: indicating extreme problems), and a separate visual analog scale (VAS).~Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score by applying country-specific weights.The range for EQ-5D-5L index score is 0 to 1 where '0' is defined as a health state equivalent to being dead and '1' is full health.The higher the score the better the health status."|Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|Core population with available data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
2566432|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Glucose||Baseline, Week 48|Participants with measurements at given time point.|||mmol/L||Standard Deviation|Mean
2563806|NCT02618928|Secondary|Change From Baseline in Fatigue Impact Scale Total Score|"The Fatigue Impact Scale (FIS) questionnaire was used to assess the impact of fatigue on the quality of life of patients.~The FIS consists of 40 items, each of which is scored 0 (no problem) to 4 (extreme problem), providing a total score from of 0 to 160, where a lower score = less fatigue impact"|Baseline, end of treatment (week 8, 12, or 24 depending on the treatment regimen), and at 12 and 24 weeks after end of treatment|Core population with non-missing data at baseline and each time point|||units on a scale||Standard Deviation|Mean
2563807|NCT02618928|Secondary|Number of Participants With Adverse Events, Serious Adverse Events, or Pregnancies||From first dose of study drug through 30 days after last dose (12 to 28 weeks depending on treatment regimen). The median (minimum, maximum) duration of treatment was 84 (4, 167) days.|All treated participants|||Participants|||Count of Participants
2563808|NCT02618928|Secondary|Number of Participants Who Received Concomitant Medications|Concomitant medication other than for chronic hepatitis C used from the time when the decision was made to initiate treatment with paritaprevir/ritonavir and ombitasvir with or without dasabuvir until after the last dose.|From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen|All treated participants|||Participants|||Count of Participants
2563809|NCT02618928|Secondary|Percentage of Ribavirin Treatment Days in Relation to the Target Number of Ribavirin Treatment Days||From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.|Core population who were prescribed ribavirin and with non-missing data|||percentage of days||Standard Deviation|Mean
2563810|NCT02618928|Secondary|Percentage of Participants With Adherence to Ribavirin by Adherence Category|"Adherence to ribavirin is expressed as a percentage of the target dose, and was calculated as:~Cumulative dose taken / (initial prescribed dose * planned duration) * 100"|From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.|Core population who were prescribed ribavirin|||Participants|||Count of Participants
2563811|NCT02618928|Secondary|Percentage of Participants With Adherence to the ABBVIE Regimen, by Adherence Category|"Adherence to the ABBVIE treatment regimen is expressed as a percentage of the target dose and was calculated as:~Cumulative dose taken / (initial prescribed dose * planned duration) * 100 The ABBVIE regimen consists of paritaprevir/r and ombitasvir with or without dasabuvir."|From first dose of study drug to end of treatment, 8 to 24 weeks depending on the treatment regimen.|Core population|||Participants|||Count of Participants
2563812|NCT02618928|Secondary|Number of Participants in Each Non-response Category 12 Weeks Post-treatment|"SVR12 non-response was categorized according to the following:~On-treatment virologic failure (breakthrough [at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment] or failure to suppress [each measured on-treatment HCV RNA value ≥ 50 IU/mL]);~Relapse, defined as HCV RNA < 50 IU/mL at EOT followed by HCV RNA ≥ 50 IU/mL post-treatment in patients who completed treatment (not more than 7 days shortened);~Death~Premature treatment discontinuation with no on-treatment virologic failure;~Insufficient virological response reported or HCV RNA ≥ 50 IU/mL post-EOT and none of the above criteria~Missing SVR12 data and/or none of the above criteria."|12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)|The Core population|||Participants|||Count of Participants
2563813|NCT02618928|Secondary|Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 24 Weeks Post-treatment (SVR24)|"Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 24 weeks after the last dose of study drug.~The Core population with sufficient follow-up data regarding SVR24 included all core population participants who~had evaluable HCV RNA data ≥ 126 days after the last actual dose of the ABBVIE REGIMEN~or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline~or had HCV RNA < 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 126 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure."|24 weeks after the last dose of study drug (week 32, 36, or 48 depending on the treatment regimen)|The Core population with sufficient follow-up data regarding SVR24|||percentage of participants||95% Confidence Interval|Number
2563814|NCT02618928|Secondary|Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)|RVR 4 was defined as participants with HCV RNA < 50 IU/mL at week 4.|Week 4|The Core population includes enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants||95% Confidence Interval|Number
2563815|NCT02618928|Secondary|Percentage of Participants With Breakthrough|Breakthrough was defined as at least one documented HCV RNA < 50 IU/mL followed by HCV RNA ≥ 50 IU/mL during treatment.|8, 12, or 24 weeks (depending on the treatment regimen)|The Core population with virological response on-treatment and with at least one on-treatment measurement thereafter (including EOT).|||percentage of participants||95% Confidence Interval|Number
2563816|NCT02618928|Secondary|Percentage of Participants With Relapse|Relapse was defined as participants with a virologic response (VR; HCV RNA < 50 IU/mL) at end of treatment (EOT) followed by HCV RNA ≥ 50 IU/mL at any time after the end of treatment.|End of treatment (week 8, 12, or 24 depending on the treatment regimen) and up to 24 weeks after the end of treatment.|The Core population with VR at EOT, who completed treatment, and had ≥ 1 HCV RNA measurement ≥ 70 days post-treatment or were a treatment failure between EOT and day 70.|||percentage of participants||95% Confidence Interval|Number
2563817|NCT02618928|Secondary|Percentage of Participants With Sufficient Follow-up Who Achieved Sustained Virological Response 12 Weeks Post-treatment|"Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug.~The Core Population with sufficient follow-up data regarding SVR12 included all core population participants who~had evaluable HCV RNA data ≥ 70 days after the last actual dose of the ABBVIE REGIMEN~or a HCV RNA value ≥ 50 IU/mL at the last measurement post-baseline~or had HCV RNA < 50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥ 70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to adverse event) or virologic failure."|12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)|The Core population with sufficient follow-up data regarding SVR12|||percentage of participants||95% Confidence Interval|Number
2563818|NCT02618928|Secondary|Percentage of Participants Achieving Virological Response at End of Treatment|Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL.|End of treatment (week 8, 12, or 24 depending on the treatment regimen)|The Core population includes enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants||95% Confidence Interval|Number
2563819|NCT02618928|Primary|Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)|Sustained virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) levels less than 50 IU/mL 12 weeks after the last dose of study drug. Participants with missing HCV RNA were counted as virological failure.|12 weeks after the last dose of study drug (week 20, 24, or 36 depending on the treatment regimen)|The Core population includes enrolled participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants||95% Confidence Interval|Number
2563820|NCT02618915|Secondary|Average Weekly Use of FIX Replacement Therapy|The use of on-demand FIX replacement therapy was recorded by dose (IU/kg) administered and the average weekly use of FIX replacement therapy was calculated. Participants were not required to stop prophylactic treatment with recombinant FIX until after Week 4 and may have been restarted on their prophylactic recombinant FIX treatment after Week 14.|Baseline (Screening), Week 0 through Week 52|As Treated Set: all participants who received any amount of DTX101, with an assessment at given time point.|||IU/kg||Standard Deviation|Mean
2563821|NCT02618915|Secondary|Number of Participants Responding to the Haemophilia-Specific Quality of Life Questionnaire|"The Haemophilia-Specific Quality of Life questionnaire asks subjects about their perceptions of their health and treatment. The questionnaire is divided into the following 10 dimensions: physical health, feelings, view of themselves, sports & leisure, work & school, dealing with hemophilia, treatment, future, family planning, and partnership & sexuality. Questions are based on a 5-point Likert-scale (1=never, 2=rarely, 3=sometimes, 4=often, 5=all the time). If the question does not apply to the subject, the not applicable response is allowed in 3 of the domains (sport & leisure, work & school, family planning). Positively worded items need to be re-coded and domains will be transformed ranging from 0 to 100; higher domain and total scores indicating a higher impairment of health-related quality of life."|Baseline (Day 0 predose), Weeks 24, 36, 48, End of Study/Early Withdrawal (up to Week 52)|Safety Set: all participants who received DTX101 including participants who received a partial dose or failed infusion.|||Participants|||Count of Participants
2563822|NCT02618915|Secondary|Number of Participants Responding to the EuroQoL-5D-5 Level (EQ-5D-5L) Questionnaire|"EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ-VAS). The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has no problems (1), some problems (2), or severe problems (3)."|Baseline (Day 0 predose), Weeks 24, 36, 48, End of Study/Early Withdrawal (up to Week 52)|Safety Set: all participants who received DTX101 including participants who received a partial dose or failed infusion.|||Participants|||Count of Participants
2563823|NCT02618915|Secondary|Number of Participants With Cell-Mediated Immune Response to FIX|The development of a cell-mediated immune response to FIX, as determined by enzyme-linked immunospot assay (ELISPOT).|Day 0 (predose), Weeks 6, 8, 12, 16, 32, 40, 48, End of Study (Week 52 for Cohort 1, Week 44 for Cohort 2)/Early Withdrawal|Safety Set: all participants who received DTX101 including subjects who received a partial dose or failed infusion.|||Participants|||Count of Participants
2563824|NCT02618915|Secondary|Number of Participants With Neutralizing Antibodies to FIX (FIX Inhibitors)|The development of neutralizing antibodies to FIX (FIX inhibitors), as determined by a Bethesda assay. A value of < 0.3 inhibitor units was considered to be no neutralizing antibodies.|Day 0 (predose), Weeks 6, 8, 16, 32, 40, End of Study (Week 52 for Cohort 1, Week 44 for Cohort 2)/Early Withdrawal|As Treated Set: all participants who received any amount of DTX101.|||Participants|||Count of Participants
2563825|NCT02618915|Secondary|Annualized FIX Replacement Therapy|The use of on-demand FIX replacement therapy was recorded by dose (IU/kg) administered, and the annualized use of FIX replacement therapy was calculated. Participants were not required to stop prophylactic treatment with recombinant FIX until after Week 4 and may have been restarted on their prophylactic recombinant FIX treatment after Week 14.|Week 0 to Week 52|As Treated Set: all participants who received any amount of DTX101.|||IU/kg||Standard Deviation|Mean
2563826|NCT02618915|Secondary|Change From Baseline in FIX Activity Over Time|Peak plasma level of FIX after IV administration as determined by the aPTT clot-based assay. Change from baseline: postbaseline value - baseline value. For the change from baseline, only participants with a value at both baseline visit and the specific postbaseline visit were included. Participants were not required to stop prophylactic treatment with recombinant FIX until after Week 4 and may have been restarted on their prophylactic recombinant FIX treatment after Week 14.|Baseline, Weeks 2, 4, 6, 8, 12, 16, 24, 32, 40, End of Study (Week 52 for Cohort 1, Week 44 for Cohort 2)/Early Withdrawal|As Treated Set: all participants who received any amount of DTX101.|||IU/dL||Standard Deviation|Mean
2563827|NCT02618915|Secondary|Annualized Bleeding Rate|The number of bleeding episodes per participant was recorded, and the annualized number of bleeding episodes was calculated.|Week 0 to Week 52|As Treated Set: all participants who received any amount of DTX101.|||bleeding episodes/year||Standard Deviation|Mean
2563828|NCT02618915|Primary|Change From Baseline in FIX Activity at Week 6|Peak plasma level of FIX after IV administration as determined by the activated partial thromboplastin time (aPTT) clot-based assay. Change from baseline: postbaseline value - baseline value. For the change from baseline, only participants with a value at both baseline visit and the specific postbaseline visit were included.|Baseline, Week 6|As Treated Set: all participants who received any amount of DTX101.|||IU/dL||Standard Deviation|Mean
2563847|NCT02618759|Secondary|Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 3)|The number of patients in each treatment group that have clinical success. Clinical Success is defined as at least a 2-grade improvement from the baseline IGA score. This measure is limited to patients with a baseline IGA score of 3, so any IGA score of 0 or 1 at Day 28 ± 2 would be a treatment success.|28 Days||||Participants|||Count of Participants
2563829|NCT02618915|Primary|Number of Participants With Adverse Events (AEs), Treatment-Related Adverse Events (TEAEs), and Serious AEs (SAEs)|An AE was defined as any untoward medical occurrence in a participant enrolled into this study (from the time the participant signed the informed consent form until his or her exit from the study), regardless of its causal relationship to study treatment. A TEAE was defined as any event not present before exposure to study product or any event already present that worsened in severity or increased in frequency after exposure to study product.|up to 52 weeks after dosing (Cohort 1) or 44 weeks after dosing (Cohort 2)|Safety Set: all participants who received DTX101 including participants who received a partial dose or failed infusion.|||Participants|||Count of Participants
2563830|NCT02618772|Other Pre-specified|Guardian/Parent's Prediction is Respect to Intervention Drug|This is a measure how how many times the parent/guardian was correct in predicting whether the patient received intranasal saline or intranasal midazolam as the intervention drug.|Day 1: parent asked immediately after procedure complete||||Times correct|||Number
2563831|NCT02618772|Other Pre-specified|Physician's Prediction is Respect to Intervention Drug|This is a measure how how many times the physician was correct in predicting whether the patient received intranasal saline or intranasal midazolam as the intervention drug.|Day 1: physician asked immediately after procedure finished||||Times correct|||Number
2563832|NCT02618772|Other Pre-specified|Length of Procedure (Mins)|This is a measure of the length of the procedure (suturing) in minutes.|Day 1||||minutes||Standard Deviation|Mean
2563833|NCT02618772|Other Pre-specified|Time That the Participant Remained in Hospital After Procedure (Mins)|Length of stay in the emergency department, measured from the end of the procedure to the time of discharge.|Day 1: at discharge from emergency department (i.e. same day)||||minutes||Standard Deviation|Mean
2563834|NCT02618772|Secondary|Per-Protocol: Faces Pain Scale-Revised/ FLACC Scale|"Faces Pain Scale: Validated self-report tool of pain for participants less than 5 years old. It is a scale that allows one to score the sensation of pain from zero to ten. The scale shows a visuals (faces) for each levels 0, 2, 4, 6, 8 and 10 of the scale. For example, 0 is represented by a face visual that expresses no hurt.~FLACC Scale: Tool to assess pain in children unable to use Faces Pain Scale-revised. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 (0 represents no pain)."|Day 1: immediately after intervention|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.|||units on a scale||Standard Deviation|Mean
2563835|NCT02618772|Secondary|Intention to Treat (ITT): Faces Pain Scale-Revised/ FLACC Scale|"Faces Pain Scale: Validated self-report tool of pain for participants less than 5 years old. It is a scale that allows one to score the sensation of pain from zero to ten. The scale shows a visuals (faces) for each levels 0, 2, 4, 6, 8 and 10 of the scale. For example, 0 is represented by a face visual that expresses no hurt.~FLACC Scale: Tool to assess pain in children unable to use Faces Pain Scale-revised. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 (0 represents no pain)."|Day 1: immediately after intervention|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.|||units on a scale||Standard Deviation|Mean
2563836|NCT02618772|Secondary|Per-Protocol: Dartmouth Operative Conditions Scale|A tool to measure the effectiveness and safety of pediatric sedation, regardless of technique used for decreasing anxiety or pain during a procedure. The scale asks the physician to rate patient states (pain/stress, movement, consciousness & sedation side effects) based on observed behaviors (each observed behavior is given a score). The scores are then added together to give a score where -3 to 5 where the lower number is indicative of less anxiety/pain.|Day 1: Immediately after suturing (prior to patient discharge from the ER, i.e. same day)|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.|||units on a scale||Standard Deviation|Mean
2563837|NCT02618772|Secondary|Intention to Treat (ITT): Dartmouth Operative Conditions Scale|A tool to measure the effectiveness and safety of pediatric sedation, regardless of technique used for decreasing anxiety or pain during a procedure. The scale asks the physician to rate patient states (pain/stress, movement, consciousness & sedation side effects) based on observed behaviors (each observed behavior is given a score). The scores are then added together to give a score where -3 to 5 where the lower number is indicative of less anxiety/pain.|Day 1: Immediately after suturing (prior to patient discharge from the ER, i.e. same day)|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.|||units on a scale||Standard Deviation|Mean
2563838|NCT02618772|Secondary|Per-Protocol: State Trait Anxiety Inventory (STAI)|"Validated measurement of anxiety, to be used to test parental/guardian anxiety at two time points. These time points are before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day). The STAI contains 10 items for assessing trait anxiety and 10 for state anxiety. All items are rated on a standard scale (Not at all, Somewhat, Moderately so, Very much so) with a range of 20 to 80 where higher scores indicate greater anxiety and lower scores indicate lower levels of anxiety."|Before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day)|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.|||units on a scale||Standard Deviation|Mean
2563839|NCT02618772|Secondary|Intention to Treat (ITT): State Trait Anxiety Inventory (STAI)|"Validated measurement of anxiety, to be used to test parental/guardian anxiety at two time points. These time points are before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day). The STAI contains 10 items for assessing trait anxiety and 10 for state anxiety. All items are rated on a standard scale (Not at all, Somewhat, Moderately so, Very much so) with a range of 20 to 80 where higher scores indicate greater anxiety and lower scores indicate lower levels of anxiety."|Day 1: Before intervention and immediately after suturing (prior to patient discharge from the ER, i.e. same day)|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.|||units on a scale||Standard Deviation|Mean
2563840|NCT02618772|Secondary|Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS)|"Measurement of patient anxiety used to test effect of anxiolytic pre-medication.The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Each item has Likert scale whereby participant's behavior is rated from 1 to 4 (Note: Vocalizations is the only item rated from 1 to 6), with higher numbers indicating the highest severity within that item. Each participant was given a mYPAS score for the suturing by two independent raters. These raters watched a digital recording of the participant undergoing suturing and from this digital recording used the mYPAS scale to assign a measurement of the participant's anxiety.~The mYPAS scale is rated as follows: Final scores = (Activity/4 + Vocal/6 + Emotional/4 + Arousal/4 + Parents/4) X 20. Scores range from 23 to 100 where a lower score is indicative of a lower level of anxiety and a higher is indicative of a higher level of anxiety."|Day 1: Baseline, Intervention & Lidocaine|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.|||units on a scale||Standard Deviation|Mean
2563841|NCT02618772|Secondary|Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS)|"Measurement of patient anxiety used to test effect of anxiolytic pre-medication.The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Each item has Likert scale whereby participant's behavior is rated from 1 to 4 (Note: Vocalizations is the only item rated from 1 to 6), with higher numbers indicating the highest severity within that item. Each participant was given a mYPAS score for the suturing by two independent raters. These raters watched a digital recording of the participant undergoing suturing and from this digital recording used the mYPAS scale to assign a measurement of the participant's anxiety.~The mYPAS scale is rated as follows: Final scores = (Activity/4 + Vocal/6 + Emotional/4 + Arousal/4 + Parents/4) X 20. Scores range from 23 to 100 where a lower score is indicative of a lower level of anxiety and a higher is indicative of a higher level of anxiety."|Day 1: During Baseline, Intervention & Lidocaine|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.|||units on a scale||Standard Deviation|Mean
2563842|NCT02618772|Primary|Per-Protocol: Modified Yale Preoperative Anxiety Score (mYPAS)|"Measurement of patient anxiety used to test effect of anxiolytic pre-medication.The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Each item has Likert scale whereby participant's behavior is rated from 1 to 4 (Note: Vocalizations is the only item rated from 1 to 6), with higher numbers indicating the highest severity within that item. Each participant was given a mYPAS score for the suturing by two independent raters. These raters watched a digital recording of the participant undergoing suturing and from this digital recording used the mYPAS scale to assign a measurement of the participant's anxiety.~The mYPAS scale is rated as follows: Final scores = (Activity/4 + Vocal/6 + Emotional/4 + Arousal/4 + Parents/4) X 20. Scores range from 23 to 100 where a lower score is indicative of a lower level of anxiety and a higher is indicative of a higher level of anxiety."|Day 1: During suturing|This is for the per-protocol analysis and thus, includes all participants who fulfill the protocol in the terms of eligibility, all interventions, and outcome assessment.|||units on a scale||Standard Deviation|Mean
2563843|NCT02618772|Primary|Intention to Treat (ITT): Modified Yale Preoperative Anxiety Score (mYPAS)|"Measurement of patient anxiety used to test effect of anxiolytic pre-medication.The mYPAS consists of 5 items (activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parents). Each item has Likert scale whereby participant's behavior is rated from 1 to 4 (Note: Vocalizations is the only item rated from 1 to 6), with higher numbers indicating the highest severity within that item. Each participant was given a mYPAS score for the suturing by two independent raters. These raters watched a digital recording of the participant undergoing suturing and from this digital recording used the mYPAS scale to assign a measurement of the participant's anxiety.~The mYPAS scale is rated as follows: Final scores = (Activity/4 + Vocal/6 + Emotional/4 + Arousal/4 + Parents/4) X 20. Scores range from 23 to 100 where a lower score is indicative of a lower level of anxiety and a higher is indicative of a higher level of anxiety."|Day 1: During suturing|This is for the Intention to Treat analysis and thus, includes all participants that received the study intervention i.e., intranasal saline or intranasal midazolam.|||units on a scale||Standard Deviation|Mean
2563844|NCT02618759|Secondary|Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 2)|The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2. This measure is limited to patients with a baseline IGA score of 2.|28 Days||||Participants|||Count of Participants
2563845|NCT02618759|Secondary|Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 2)|The number of patients in each treatment group that have clinical success. Clinical Success is defined as at least a 2-grade improvement from the baseline IGA score. This measure is limited to patients with a baseline IGA score of 2, so only an IGA score of 0 at Day 28 ± 2 would be a treatment success.|28 Days||||Participants|||Count of Participants
2563846|NCT02618759|Secondary|Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 3)|The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2. This measure is limited to patients with a baseline IGA score of 3.|28 Days||||Participants|||Count of Participants
2563896|NCT02617784|Primary|AUC of Oseltamivir in CAPD Participants During Days 1 to 6|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||ng*h/mL||Standard Deviation|Mean
2563848|NCT02618759|Primary|Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2|The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2.|28 Days||||Participants|||Count of Participants
2563849|NCT02618759|Primary|Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2|The number of patients in each treatment group that have clinical success. Clinical Success is at least a 2-grade improvement from the baseline IGA score. The minimum IGA value is 0, and maximum value is 5. A higher number represents a more severe case of plaque psoriasis. Patients are required to have an IGA score of 2 or 3 at baseline, so all clinical success IGA scores will be either 0 or 1.|28 Days||||Participants|||Count of Participants
2563850|NCT02618642|Primary|Calculation of Motor I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses|Based on the results of the electrodiagnostic test, Motor I/T curve was plotted for triangular (▲I/T coeff) pulses.The I/T curve coefficient was calculated as the mean value of the electric charge that caused the motor response (threshold muscle contraction) according to the following equations:▲I/T coeff = (q1+q2+… +q10) /10 , where pulse current × pulse duration = q in coulombs. Comparisons were made based on the changes in the ▲I/T coeff, observed as a result of PILER irradiations.|baseline measurement and 3 weeks after a series of 10 phototherapy treatments||||Coulomb||Standard Deviation|Mean
2563851|NCT02618642|Primary|Calculation of Motor i/t Curve Coefficient for Rectangle (■I/T Coeff)|Based on the results of the electrodiagnostic test, motor I/T curve was plotted for rectangular (■) pulses.The I/T curve coefficient was calculated as the mean value of the electric charge that caused the motor response (threshold muscle contraction) according to the following equations:■I/T coeff = (q1+q2 +…+q13 )/13 , where pulse current × pulse duration = q in coulombs. Comparisons were made based on the changes in the ■I/T coeff, observed as a result of PILER irradiations.|baseline measurement and 3 weeks after a series of 10 phototherapy treatments||||Coulomb||Standard Deviation|Mean
2563852|NCT02618642|Primary|Calculation of Sensory I/T Curve Coefficient for Triangular (▲I/T Coeff) Pulses|Based on the results of the electrodiagnostic test, sensory I/T curve was plotted for triangular (▲I/T coeff) pulses.The I/T curve coefficient was calculated as the mean value of the electric charge that caused the sensory response (notification by the subject of the sensation of current vibrations) according to the following equations:▲I/T coeff = (q1+q2+… +q10) /10 , where pulse current × pulse duration = q in coulombs. Comparisons were made based on the changes in the ▲I/T coeff, observed as a result of PILER irradiations.|baseline measurement and 3 weeks after a series of 10 phototherapy treatments||||Coulomb||Standard Deviation|Mean
2563853|NCT02618642|Primary|Calculation of Sensory i/t Curve Coefficient for Rectangle (■I/T Coeff)|Based on the results of the electrodiagnostic test, sensory I/T curve was plotted for rectangular (■) pulses.The I/T curve coefficient was calculated as the mean value of the electric charge that caused the sensory response (notification by the subject of the sensation of current vibrations) according to the following equations:■I/T coeff = (q1+q2 +…+q13 )/13 , where pulse current × pulse duration = q in coulombs. Comparisons were made based on the changes in the ■I/T coeff, observed as a result of PILER irradiations.|baseline measurement and 3 weeks after a series of 10 phototherapy treatments||||Coulomb||Standard Deviation|Mean
2563854|NCT02618642|Primary|Change in the Pressure Pain Threshold (PPT)|Increase in PPT meant decrease in sensitivity to pressure in the muscle. Decrease in PPT meant increase in sensitivity to pressure in the muscle.|baseline measurement and 3 weeks after a series of 10 phototherapy treatments||||lbs||Standard Deviation|Mean
2563855|NCT02618512|Primary|Safety and Tolerability of SBC-103|The planned primary endpoint of this study was safety and tolerability of SBC-103 in patients with MPS IIIB, as measured by Number of participants with treatment-emergent adverse events, including serious adverse events; infusion-associated reactions; incidence of antidrug antibodies, clinical laboratory tests, cerebrospinal fluid findings, vital signs, and prior and concomitant medications|Planned duration was baseline to 164 weeks but due to early termination of the study, actual is 96 weeks.||||Participants|||Count of Participants
2563856|NCT02618187|Secondary|Endoscopic Improvement|Defined as a decrease in endoscopic subscore >= 1|8 weeks|ITT, where the following were counted as missing: missing post-treatment endoscopy; adding UC medication for a flare during the treatment period; early termination prior to Day 48|||Participants|||Count of Participants
2563857|NCT02618187|Secondary|Clinical Remission|"Defined as a Total Modified Mayo Score <= 2 and an endoscopic subscore <= 1.~The Total Modified Mayo Score is a measure of UC disease activity which ranges from 0 to 12 points and consists of four subscores (stool frequency, rectal bleeding, endoscopy, and physician global assessment), each graded from 0 to 3, with higher scores indicating more severe disease. The four components are summed together for a composite score, with a higher overall score indicating more severe disease (0 = no disease; 12 = worst disease). The Modified Mayo endoscopic subscore excludes friability from an endoscopic subscore of 1."|8 weeks|ITT, where the following were counted as missing: missing post-treatment endoscopy; adding UC medication for a flare during the treatment period; early termination prior to Day 48|||Participants|||Count of Participants
2563858|NCT02618187|Primary|Engraftment of SER-287 Bacteria in All Treatment Arms|The stool microbiomes of SERES-101 subjects, before and after treatment with SER-287, were characterized using whole metagenomic sequencing (WMS). SER-287 drug product was also characterized using WMS. Microbiome engraftment was assessed by the number of spore-forming species in the drug product lots that were also detected in subjects' post-treatment fecal samples but not detected at baseline.|Baseline and 8 weeks|Sensitivity Analysis Population - 1 (all randomized subjects with an evaluable stool sample collected at baseline and one evaluable stool sample collected at Visit 12 or Early Termination (ET) visit collected within a two-week window surrounding Visit 12)|||Richness SER-287 spore-forming species||Standard Deviation|Mean
2563897|NCT02617784|Primary|Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43|Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose|PK Analysis Population (Second Dose Subpopulation).|||ng/mL||Standard Deviation|Mean
2563859|NCT02618187|Primary|Composition of the Intestinal Microbiome|Changes in the composition of the microbiome were characterized by whole metagenomic sequencing (WMS) of subjects' stool samples. Changes in the composition of the microbiome were measured by quantifying the number of unique types of spore-forming bacteria detected in subjects' stool samples after eight weeks of induction treatment versus baseline.|Baseline and 8 weeks|Sensitivity Analysis Population - 1 (all randomized subjects with an evaluable stool sample collected at baseline and one evaluable stool sample collected at Visit 12 or Early Termination (ET) visit collected within a 2 week window surrounding Visit 12)|||Richness of spore-forming species||Standard Deviation|Mean
2563860|NCT02618187|Primary|Safety and Tolerability of SER-287|Treatment-Emergent Adverse Events Incidence by Treatment, System Organ Class and Preferred Term. The treatment period with SER-287 was eight weeks. All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.|Day 246|Safety population|||Participants|||Count of Participants
2563861|NCT02618031|Secondary|Modified Rankin Score (mRS) Between Favorable CIS With Good Revascularization Versus Poor CIS With Good Revascularization.|"Revascularization status will be classified as poor (mTICI = 0-2A) or good (mTICI = 2B, 3). Rate of good clinical outcomes between groups will be compared based on the combination of CIS and revascularization status. Good outcome will be measured based on the modified Rankin scale score according to:~0: No symptoms~No significant disability despite symptoms~Slight disability~Moderate disability~Moderately severe disability~Severe disability~Dead A score of 0-2 is considered a good outcome"|90 days|output = number of patients with a good outcome one patient was lost to follow up|||Participants|||Count of Participants
2563862|NCT02618031|Secondary|Complication Rate Between Favorable CIS Group Versus Poor CIS Group|Complication : Clinically relevant intracranial hemorrhage and vasogenic edema as defined by parenchymal hematoma (PH) 1 or 2|1 day - 1 week|post-operative bleeding was not available for two subjects who died before a postoperative scan|||Participants|||Count of Participants
2563863|NCT02618031|Primary|Modified Rankin Score (mRS) Between Favorable CIS Group Versus Poor CIS Group.|The mRS Score ranges from 0-6 and describes the degree of disability or dependence after a stroke. The grades are no symptoms (0), no significant disability (1), slight disability (2), moderate disability (3), moderately severe disability (4), severe disability (5), and death (6).|90 days|A good outcome is defined as mRS 0-2|||Participants|||Count of Participants
2563864|NCT02617901|Primary|Number of Participants With Observer Agreement Between Bone Age as Assessed From Left Hand and Wrist DXA Compared to Radiographs|"Bone age was assessed from DXA and conventional radiographs of the left hand and wrist based on the Greulich and Pyle and Tanner and Whitehouse methods of bone age assessment.~Interclass correlation was calculated to determine observer agreement between radiographs and DXA"|18 months|Children presenting to Endocrine Clinic|||Participants|||Count of Participants
2563865|NCT02617888|Primary|Number of Excess Double-strand DNA Break Foci Per Cell in Peripheral Blood Samples Post-imaging|The amount of excess DNA double-strand break foci per cell after cardiac computed tomographic angiography (CCTA) in female patients with and without breast shields, minus the amount of foci prior to CCTA. In addition, changes in DNA double-strand breaks from baseline following cardiac testing in the observational arm is being assessed in an observational manner.|Change from baseline double strand DNA breaks at 30 minutes post-imaging|Female patients 18 years or older who were clinically referred to undergo coronary CT angiography between August 2012 and July 2014 at Walter Reed National Military Medical Center (Bethesda, Maryland) were eligible for enrollment.|||gamma-H2AX foci in blood lymphocytes||Standard Deviation|Mean
2563866|NCT02617784|Secondary|Percentage of Oseltamivir Dose Eliminated by Dialysis as Metabolite Oseltamivir Carboxylate in CAPD Participants|Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as [amount of metabolite in dialysate divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||percentage of oseltamivir dose||Standard Deviation|Mean
2563867|NCT02617784|Secondary|Percentage of Oseltamivir Dose Eliminated by Dialysis as Unchanged Drug in CAPD Participants|Dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate dialysis elimination, computed as [amount of drug in dialysate divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||percentage of oseltamivir dose||Standard Deviation|Mean
2563868|NCT02617784|Secondary|Percentage of Oseltamivir Dose Renally Excreted as Metabolite Oseltamivir Carboxylate in CAPD Participants|Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as [amount of metabolite in urine divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Urine samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||percentage of oseltamivir dose||Standard Deviation|Mean
2563869|NCT02617784|Secondary|Percentage of Oseltamivir Dose Renally Excreted as Unchanged Drug in CAPD Participants|Urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate renal excretion, computed as [amount of drug in urine divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Urine samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||percentage of oseltamivir dose||Standard Deviation|Mean
2563870|NCT02617784|Secondary|CLd of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples up to 120 hours and dialysate samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLd, computed as [amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval]. The CLd was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||L/h||Standard Deviation|Mean
2563986|NCT02615535|Secondary|Change in Beck Anxiety Inventory|Subjects rate on a 0-3 likert scales responses to questions about anxiety. Scores range from 0-63. Lower scores mean a better outcome.|baseline and six weeks||||score on a scale||Standard Error|Mean
2563871|NCT02617784|Secondary|CLr of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma and urine samples up to 48 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as [amount of metabolite excreted divided by the AUC48]. The CLr was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 dose; urine samples 0 to 48 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||L/h||Standard Deviation|Mean
2563872|NCT02617784|Secondary|CLr of Oseltamivir in CAPD Participants|Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 6) were used to calculate CLr, computed as [amount of drug excreted divided by the AUC12]. The CLr was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||L/h||Standard Deviation|Mean
2563873|NCT02617784|Secondary|CL/F of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples up to 48 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48 hours from D1 and D36 dose|PK Analysis Population.|||L/h||Standard Deviation|Mean
2563874|NCT02617784|Secondary|CL/F of Oseltamivir in CAPD Participants|Plasma samples up to 12 hours post-dose during the first (Days 1 to 6) and second (Days 36 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D36 dose|PK Analysis Population.|||L/h||Standard Deviation|Mean
2563875|NCT02617784|Secondary|Terminal Elimination Half-Life of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The time required for the concentration to decrease by one-half was recorded and averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population.|||hours||Standard Deviation|Mean
2563876|NCT02617784|Secondary|Elimination Rate Constant of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). Urine and dialysate samples were also obtained up to 48 hours post-dose during the first dose analysis. The elimination rate constant was calculated as [natural log (ln)(2) divided by the half-life] and expressed as inverse hours (1/h).|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose; urine samples 0 to 48 hours from D1 dose; dialysate samples 0 to 48 hours from D1 dose|PK Analysis Population.|||1/h||Standard Deviation|Mean
2563877|NCT02617784|Secondary|Tmax of Metabolite Oseltamivir Carboxylate in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose|PK Analysis Population.|||hours||Standard Deviation|Mean
2563878|NCT02617784|Secondary|Tmax of Oseltamivir in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose|PK Analysis Population.|||hours||Standard Deviation|Mean
2563879|NCT02617784|Secondary|Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in CAPD Participants|Plasma samples were obtained up to 120 post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose|PK Analysis Population.|||ng/mL||Standard Deviation|Mean
2563880|NCT02617784|Secondary|Plasma Concentration of Oseltamivir by Timepoint in CAPD Participants|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6) and up to 168 hours post-dose during the second dose analysis (Days 36 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 and D36 dose AND at 168 hours from D36 dose|PK Analysis Population.|||ng/mL||Standard Deviation|Mean
2563881|NCT02617784|Secondary|Plasma Concentration of Metabolite Oseltamivir Carboxylate in Arterial and Venous Blood by Timepoint in HD Participants|Dialyzer samples were obtained up to 5 hours from the start of dialysis on Days 3 and 40 (corresponding to HD sessions 2 and 18). Arterial concentrations were estimated using the inflow to the dialyzer, and venous concentrations were estimated using the outflow from the dialyzer. The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40|PK Analysis Population.|||ng/mL||Standard Deviation|Mean
2563882|NCT02617784|Secondary|Percentage of Oseltamivir Dose Excreted as Metabolite Oseltamivir Carboxylate in HD Participants|Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate metabolite excretion, computed as [amount of metabolite excreted divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Urine samples 0 to 42 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||percentage of osteltamivir dose||Standard Deviation|Mean
2563898|NCT02617784|Primary|Cmax of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||ng/mL||Standard Deviation|Mean
2563883|NCT02617784|Secondary|Percentage of Oseltamivir Dose Excreted as Unchanged Drug in HD Participants|Urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate drug excretion, computed as [amount of drug excreted divided by the oral oseltamivir dose] multiplied by 100. The value was averaged among all participants and expressed as a percent of the oseltamivir dose administered.|Urine samples 0 to 42 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||percentage of oseltamivir dose||Standard Deviation|Mean
2563884|NCT02617784|Secondary|Dialysis Clearance (CLd) of Metabolite Oseltamivir Carboxylate in HD Participants|Plasma samples up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, in addition to dialyzer samples obtained on Days 3 and 40, were used to calculate CLd, computed as [amount of metabolite recovered in dialysate divided by the AUC over the dialysis interval]. The CLd with each dose was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from from D1 and D38 dose; dialyzer samples 1, 2, 4, 5 hours from start of dialysis on Days 3 and 40|PK Analysis Population; n = number of participants included in the specific dose analysis.|||L/h||Standard Deviation|Mean
2563885|NCT02617784|Secondary|CLr of Metabolite Oseltamivir Carboxylate in HD Participants|Plasma and urine samples up to 42 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as [amount of metabolite excreted divided by the AUC42]. The CLr was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 dose; urine samples 0 to 42 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||L/h||Standard Deviation|Mean
2563886|NCT02617784|Secondary|Renal Clearance (CLr) of Oseltamivir in HD Participants|Plasma and urine samples up to 12 hours post-dose during the first dose analysis (Days 1 to 5) were used to calculate CLr, computed as [amount of drug excreted divided by the AUC12]. The CLr was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12 hours from D1 dose; urine samples 0 to 12 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||L/h||Standard Deviation|Mean
2563887|NCT02617784|Secondary|CL/F of Metabolite Oseltamivir Carboxylate in HD Participants|Plasma samples up to 42 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in L/h.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42 hours from D1 and D38 dose|PK Analysis Population; n = number of participants included in the specific dose analysis.|||L/h||Standard Deviation|Mean
2563888|NCT02617784|Secondary|Oral Plasma Clearance (CL/F) of Oseltamivir in HD Participants|Plasma samples up to 12 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses were used to calculate apparent clearance adjusted for oral bioavailability. The CL/F with each dose was averaged among all participants and expressed in liters per hour (L/h).|Blood samples 0, 1, 2, 4, 8, 12 hours from D1 and D38 dose|PK Analysis Population; n = number of participants included in the specific dose analysis.|||L/h||Standard Deviation|Mean
2563889|NCT02617784|Secondary|Tmax of Metabolite Oseltamivir Carboxylate in HD Participants|Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose|PK Analysis Population; n = number of participants included in the specific dose analysis.|||hours||Standard Deviation|Mean
2563890|NCT02617784|Secondary|Time to Maximum Plasma Concentration (Tmax) of Oseltamivir in HD Participants|Plasma samples were obtained up to 90 hours post-dose during the first (Days 1 to 5) and second (Days 38 to 43) dose analyses, and the observed time of maximum concentration was recorded. The Tmax following each dose was averaged among all participants and expressed in hours.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 and D38 dose|PK Analysis Population; n = number of participants included in the specific dose analysis.|||hours||Standard Deviation|Mean
2563891|NCT02617784|Secondary|Plasma Concentration of Metabolite Oseltamivir Carboxylate by Timepoint in HD Participants|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose|PK Analysis Population; n = number of participants included at specified timepoints in the analysis.|||ng/mL||Standard Deviation|Mean
2563892|NCT02617784|Secondary|Plasma Concentration of Oseltamivir by Timepoint in HD Participants|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5) and up to 114 hours post-dose during the second dose analysis (Days 38 to 43). The concentration at each collection time was recorded and averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49 hours from D1 and D38 dose AND at 90 hours from D1 dose AND at 114 hours from D38 dose|PK Analysis Population; number (n) equals (=) number of participants included at specified timepoints in the analysis.|||ng/mL||Standard Deviation|Mean
2563893|NCT02617784|Primary|AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 36 to 43|Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC48 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose|PK Analysis Population (Second Dose Subpopulation).|||ng*h/mL||Standard Deviation|Mean
2563894|NCT02617784|Primary|AUC of Metabolite Oseltamivir Carboxylate in CAPD Participants During Days 1 to 6|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the AUC was determined from 0 to 48 hours (AUC48) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||ng*h/mL||Standard Deviation|Mean
2563895|NCT02617784|Primary|AUC of Oseltamivir in CAPD Participants During Days 36 to 43|Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from D36 dose|PK Analysis Population (Second Dose Subpopulation).|||ng*h/mL||Standard Deviation|Mean
2563899|NCT02617784|Primary|Cmax of Oseltamivir in CAPD Participants During Days 36 to 43|Plasma samples were obtained up to 168 hours post-dose during the second dose analysis (Days 36 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120, 168 hours from Day 36 (D36) dose|PK Analysis Population (Second Dose Subpopulation).|||ng/mL||Standard Deviation|Mean
2563900|NCT02617784|Primary|Cmax of Oseltamivir in CAPD Participants During Days 1 to 6|Plasma samples were obtained up to 120 hours post-dose during the first dose analysis (Days 1 to 6), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 24, 48, 72, 120 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||ng/mL||Standard Deviation|Mean
2563901|NCT02617784|Primary|AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43|Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC42 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose|PK Analysis Population (Second Dose Subpopulation).|||ng*h/mL||Standard Deviation|Mean
2563902|NCT02617784|Primary|AUC of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 42 hours (AUC42) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||ng*h/mL||Standard Deviation|Mean
2563903|NCT02617784|Primary|AUC of Oseltamivir in HD Participants During Days 38 to 43|Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the AUC12 and AUClast were determined. Values were averaged among all participants and expressed in ng*h/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose|PK Analysis Population (Second Dose Subpopulation).|||ng*h/mL||Standard Deviation|Mean
2563904|NCT02617784|Primary|Area Under the Concentration-Time Curve (AUC) of Oseltamivir in HD Participants During Days 1 to 5|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the AUC was determined from 0 to 12 hours (AUC12) and up to the last measurable concentration (AUClast). Values were averaged among all participants and expressed in nanograms by hours per milliliter (ng*h/mL).|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||ng*h/mL||Standard Deviation|Mean
2563905|NCT02617784|Primary|Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 38 to 43|Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D38 dose|PK Analysis Population (Second Dose Subpopulation).|||ng/mL||Standard Deviation|Mean
2563906|NCT02617784|Primary|Cmax of Metabolite Oseltamivir Carboxylate in HD Participants During Days 1 to 5|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from D1 dose|PK Analysis Population (First Dose Subpopulation).|||ng/mL||Standard Deviation|Mean
2563907|NCT02617784|Primary|Cmax of Oseltamivir in HD Participants During Days 38 to 43|Plasma samples were obtained up to 90 hours post-dose during the second dose analysis (Days 38 to 43), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in ng/mL.|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 38 (D38) dose|PK Analysis Population (Second Dose Subpopulation): All participants who completed treatment and provided evaluable data during the second dose assessment period.|||ng/mL||Standard Deviation|Mean
2563908|NCT02617784|Primary|Maximum Plasma Concentration (Cmax) of Oseltamivir in HD Participants During Days 1 to 5|Plasma samples were obtained up to 90 hours post-dose during the first dose analysis (Days 1 to 5), and the maximum observed concentration was recorded. The Cmax was averaged among all participants and expressed in nanograms per milliliter (ng/mL).|Blood samples 0, 1, 2, 4, 8, 12, 20, 32, 42, 48, 49, 90 hours from Day 1 (D1) dose|Pharmacokinetic (PK) Analysis Population (First Dose Subpopulation): All participants who completed treatment and provided evaluable data during the first dose assessment period.|||ng/mL||Standard Deviation|Mean
2563909|NCT02617667|Primary|Change From Baseline (Visit 1) in Dryness Severity Visual Analog Scale (VAS) at 113 Days|"The primary analysis and objective of the study was to compare the the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. Furthermore, the open label character could have had an impact on patient reported outcomes. The symptom endpoint was the change from baseline in severity of dryness VAS at Day 113. Dryness severity was rated from 0 to 100%, where 0% corresponds to no dryness and 100% corresponds to maximum dryness."|Baseline to 113 Days|Full analysis set population for worst eye. Worst eye: Eyes were eligible for analysis if they met all inclusion criteria. If both eyes qualified, the worst eye was taken as the eye with higher (worse) staining at Visit 1. If staining was the same, the right eye was taken.|||units on a scale||Standard Deviation|Mean
2563910|NCT02617667|Primary|Change From Baseline (Visit 1) in Total Corneal Fluorescein Staining at 113 Days|The primary analysis and objective of the study was to compare the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. The sign endpoint was the change from baseline in total corneal fluorescein staining at day 113. The cornea is divided into five regions: central, superior, inferior, nasal and temporal. Each region is graded from 0-3 based on the National Eye Institute scale, where 0 indicates no staining and 3 maximal staining. The total score is the sum of all these regions. The maximum score for each eye is 15.|Baseline to 113 Days|Full analysis set population for worst eye. Worst eye: Eyes were eligible for analysis if they met all inclusion criteria. If both eyes qualified, the worst eye was taken as the eye with higher (worse) staining at Visit 1. If staining was the same, the right eye was selected as the worst eye.|||units on a scale||Standard Deviation|Mean
2563911|NCT02617628|Secondary|Reincarceration|percent incarcerated|0 to 28 months|This outcome was determined as follows: one XR-NTX injection provided 4 weeks of treatment. Study patients also had counseling, thus weeks in treatment equaled the weeks of protected time from XR-NTX plus the number of weeks a patient had one or more counseling appointments after the protection from the last XR-NTX dose ended.|||Participants|||Count of Participants
2563912|NCT02617628|Primary|Relapse to Opioid Use in Subjects by Month 3|Proportion (count) without relapse by month 3 post release. At each monthly assessment we determined whether a subject relapsed based on the timeline follow-back (TLFB) and/or urine drug screen results (UDS) and self-reported withdrawal.|12 weeks (month 3)|"In treatment arm 1 (before reentry) 38 subjects received vivitrol before leaving prison.~In treatment arm 2 (after reentry) 48 subjects were eligible to receive injections after release from prison. Arm 2 subjects were to return to the research clinic within 7 days after release to receive their first injection."|||Participants|||Count of Participants
2563913|NCT02616900|Secondary|Improvement in Visual Contrast Performance in Log Units.|"The study seeks to quantify, after a period of usage of the device of three months, improvement in contrast performance using a standard optometric Mars Contrast Chart. Outcome is measured in Log Units ranging from 0.04 to 1.92 in decrements of 0.04 log units, a higher score indicating better contrast performance. The scale of the Mars Contrast Chart is interpreted as follows:~0.0 - 0.5 Log Units: Profound Loss 0.5 - 1.0 Log Units: Severe Loss 1.0 - 1.5 Log Units: Moderate Loss 1.5 - 1.75 Log Units: Normal Vision (>60yrs) >1.75 Log Units: Normal Vision (<60yrs)"|Baseline and after three months of device use.||||Log Units||Standard Deviation|Mean
2563914|NCT02616900|Secondary|Improvement in Visual Acuity|"The study seeks to quantify, after a period of usage of the device of three months, improvement in visual acuity using standard optometric charts (e.g. 20/400 to 20/160, etc.). We measured LogMAR acuity on a standard ETDRS chart. Results show an average greater than seven-line improvement (-0.76 LogMAR)."|Baseline and after three months of device use.||||LogMAR||Standard Deviation|Mean
2563915|NCT02616900|Primary|Quality of Life Improvement After Three Months of Device Use|"The study seeks to quantify, after a period of usage of the device of three months, improvement in subjects' Quality of Life using the validated tool, Veterans Affairs (VA) Low Vision (LV) Visual Functioning Questionnaire (VFQ) - 48 Questions (VA LV VFQ-48). Quality of Life is measured in Logits. Individual scores ranged from -5 to +10 (a higher number is a better score). Overall improvement was 0.84 Logits."|Baseline and after three months of device use.||||Logits||Standard Deviation|Mean
2563916|NCT02616783|Secondary|Change in Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||cells/μL||Standard Deviation|Mean
2563917|NCT02616783|Secondary|Change From Baseline in CD4+ Cell Count at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.|||cells/μL||Standard Deviation|Mean
2563918|NCT02616783|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and did not have any major protocol violations.|||Percentage of participants|||Number
2563919|NCT02616783|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and did not have any major protocol violations.|||Percentage of participants|||Number
2563920|NCT02616783|Secondary|Percent Change From Baseline to Week 24 in Hip BMD||Baseline; Week 24|Participants in the Hip DXA Analysis Set with available data were analyzed.|||Percent change||Standard Deviation|Mean
2563921|NCT02616783|Secondary|Percent Change From Baseline to Week 24 in Spine BMD||Baseline; Week 24|Participants in the Spine DXA Analysis Set with available data were analyzed.|||Percent change||Standard Deviation|Mean
2563922|NCT02616783|Primary|Percent Change From Baseline to Week 48 in Hip BMD||Baseline; Week 48|Participants in the Hip DXA Analysis Set with available data were analyzed.|||Percent change||Standard Deviation|Mean
2563923|NCT02616783|Primary|Percent Change From Baseline to Week 48 in Spine BMD||Baseline; Week 48|Participants in the Spine DXA Analysis Set with available data were analyzed.|||Percent change||Standard Deviation|Mean
2563924|NCT02616601|Primary|Percentage of Participants With Treatment Success (Complete Clearance) at Week 6|Percentage of participants with treatment success (complete clearance) at Week 6 (4 weeks after completion of 2 weeks of treatment). Complete clearance was defined as having no (zero) clinically visible actinic keratoses (AK) lesions in the treatment area at the Week 6/End Of Study visit. All AK lesions (baseline and new lesions) independent of size within the treatment area were treated and included in the efficacy lesion count.|Week 6|Participants in mlTT population who met inclusion/exclusion criteria, applied 75%-125% applications of study drug, did not miss applications for more than 3 consecutive days, no evidence of dosing noncompliance, and completed evaluation at Week 6 within ±4 days with no protocol violations that would affect treatment evaluation (PP Population).|||percentage of participants|||Number
2563925|NCT02616523|Other Pre-specified|Complication|complications such as obstipation in the postoperative period|up to two weeks|||||||
2563926|NCT02616523|Secondary|Neuropathic Pain (Pain Questionnaire) dn4|Pain questionnaire dn4 will be send to participants after two months of surgery to evaluate the neuropathic pain. There are minimum 0 points and maximum 10 points. If the score is 4 or higher then the pain is likely to be neuropathic pain.|two months after the surgery||||units on a scale||Standard Deviation|Mean
2563927|NCT02616523|Secondary|Consumption of Piritramide|consumption of piritramide (mg) in the recovery room|one hour after the operation||||mg||Standard Deviation|Mean
2563928|NCT02616523|Primary|Consumption of Fentanyl|consumption of fentanyl (mg) during the procedure|time of the operation||||mg||Standard Deviation|Mean
2563929|NCT02616380|Secondary|Healthcare Resource Utilization: Number of Participants Who Received Concomitant Medications for Rheumatoid Arthritis|The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.|24 weeks|All enrolled participants|||Participants|||Count of Participants
2563930|NCT02616380|Secondary|Healthcare Resource Utilization: Number of Participants With Hospitalization Related to Rheumatoid Arthritis|The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.|24 weeks|All enrolled participants|||Participants|||Count of Participants
2563931|NCT02616380|Secondary|Healthcare Resource Utilization: Number of Participants Who Underwent Procedures Related to Treatment of Rheumatoid Arthritis|The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.|24 weeks|All enrolled participants|||Participants|||Count of Participants
2563932|NCT02616380|Secondary|Healthcare Resource Utilization: Number of Participants With Visits to Healthcare Professionals for Treatment of Rheumatoid Arthritis|The healthcare resource utilization (HCRU) questionnaire collected data on the healthcare resources used over the course of the study.|24 weeks|All enrolled participants|||Participants|||Count of Participants
2563933|NCT02616380|Secondary|Percentage of Participants Achieving a Clinically Meaningful Improvement on the HAQ-DI at Weeks 12 and 24|"The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability.~A clinically meaningful improvement was defined as an improvement of -0.22 points or greater in the HAQ-DI score."|Baseline, week 12 and week 24|Participants still receiving adalimumab and with available data at each time point.|||percentage of participants|||Number
2563934|NCT02616380|Secondary|Change From Baseline in HAQ DI Score at Week 12|The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability.|Week 0 and Week 12|Participants who were still receiving adalimumab at week 24 and with available HAQ-DI data at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2563935|NCT02616380|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) at Weeks 12 and 24|The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in RA consisting of 6 questions, based on patient recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), overall work impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. A negative change from baseline indicates improvement.|Baseline, week 12, and week 24|Participants still receiving adalimumab and with available data at each time point. Overall work impairment was only assessed in participants who were employed.|||percent impairment||Standard Deviation|Mean
2563936|NCT02616380|Secondary|Change From Baseline in EuroQol 5-Dimension 3-Level (EQ-5D-3L) Index at Weeks 12 and 24|The EQ-5D-5L descriptive system comprises 5 dimensions of health-related quality of life states (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which can take one of three responses. The responses record three levels of severity ('no problems', 'some problems', and 'extreme problems') within a particular EQ-5D-3L dimension. The EQ-5D-3L results were converted into a weighted health state index with scores ranging from approximately 0 (death) to 1 (full health). A positive change from baseline indicates improvement.|Baseline, week 12, and week 24|Participants still receiving adalimumab and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2563937|NCT02616380|Secondary|Change From Baseline in Short-Form 36 (SF-36) Physical Component Summary and Mental Component Summary Scores at Weeks 12 and 24|"The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).~The summary physical health score included the following subscales: physical functioning, role-physical, bodily pain, and general health. The summary mental health score included the following subscales: vitality, social functioning, role-emotional, and mental health.~Each score ranges from 0 to 100 where higher scores indicate a better quality of life. A positive change from Baseline score indicates an improvement."|Baseline, week 12, and week 24|Participants still receiving adalimumab and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2563938|NCT02616380|Primary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24|The HAQ-DI is a patient-reported assessment of physical function that includes 20 items in eight categories representing a comprehensive set of functional activities, including dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Patients were asked about their ability to complete these tasks in the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (best) to 3 (worst), with a higher score representing a high-dependency disability.|Baseline and Week 24|Participants who were still receiving adalimumab at week 24 and with available HAQ-DI data at baseline and week 24.|||units on a scale||Standard Deviation|Mean
2563939|NCT02616250|Primary|Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA):|Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1)|week 12/Hour 3|Intent To Treat (ITT) Population|||Participants|||Count of Participants
2563940|NCT02616146|Secondary|Number of Participants With Absence of Withdrawal Bleeding (AWB), by Cycle|Participants were asked to keep a daily diary to record vaginal bleeding events. AWB was defined as no bleeding/spotting during the expected bleeding period. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.|Up to 1 year|FAS Evaluable population, defined as a subset of FAS population that met the following criteria: a) No more than 2 consecutive days with missing bleeding data on Daily Diary unless there was at least one day with BTB-S during the ring-use interval; and b) treatment cycle length (including hormone-free interval) is between 22 and 35 days, inclusive.|||Participants|||Count of Participants
2563941|NCT02616146|Secondary|Number of Participants With Breakthrough Bleeding/Spotting (BTB-S), by Cycle|BTB-S was considered any bleeding/spotting that occurred during expected non-bleeding interval that was neither early nor continued withdrawal bleeding. BTB-S was classified as follows: Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.|Up to 1 year|FAS Evaluable population, defined as a subset of FAS population that met the following criteria: a) No more than 2 consecutive days with missing bleeding data on Daily Diary unless there was at least one day with BTB-S during the ring-use interval; and b) treatment cycle length (including hormone-free interval) is between 22 and 35 days, inclusive.|||Participants|||Count of Participants
2563942|NCT02616146|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.|Up to 1 year|This primary endpoint was based on all randomized participants in whom at least one vaginal ring was inserted or one comparator tablet was ingested.|||Participants|||Count of Participants
2563943|NCT02616146|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.|Up to 1 year|This primary endpoint was based on all randomized participants in whom at least one vaginal ring was inserted or one comparator tablet was ingested.|||Participants|||Count of Participants
2563944|NCT02616146|Primary|Number of In-Treatment Pregnancies Per 100 Woman-Years of Exposure in Participants 18-35 Years of Age (Pearl Index)|The Primary Efficacy Outcome Measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure (one woman-year defined as a period of 365.25 days). NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.|Up to 1 year (13 28-day cycles)|restricted Full Analysis Set (rFAS) population, defined as the population of women with at least one “at risk” treatment cycle without documented use of hormonal or nonhormonal backup contraception during the cycle, or participants with a treatment cycle (at risk or not) in which a pregnancy has occurred.|||Pregnancies per 100 woman years|||Number
2563945|NCT02616029|Secondary|Change From Day 1 in CD4+ Cell Count at Week 48||Day 1, Week 48|||||||
2563946|NCT02616029|Secondary|Change From Day 1 in CD4+ Cell Count at Week 24||Week 24|Participants in the Full Analysis Set with available data were analyzed.|||cells/µL||Standard Deviation|Mean
2563947|NCT02616029|Secondary|Change From Day 1 in CD4+ Cell Count at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.|||cells/µL||Standard Deviation|Mean
2563948|NCT02616029|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA Snapshot Analysis||Week 48|||||||
2563949|NCT02616029|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the FDA Snapshot Analysis|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 24 window was between Day 141 and 210 (inclusive).|Week 24|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2563950|NCT02616029|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the FDA Snapshot Analysis|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was also analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 12 window was between Day 71 and 98 (inclusive).|Week 12|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2563951|NCT02616029|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using PVR||Week 48|||||||
2564021|NCT02614729|Primary|Daily Energy Intake: Total Daily Intake|Energy intake during breakfast, lunch, dinner, and evening snacks of each day 7 testing day (separated by 3-4 weeks) will be measured.|5 months||||kcal||Standard Error|Mean
2563952|NCT02616029|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 Using PVR|The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 24 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL followed by discontinuation from the study.|Week 24|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2563953|NCT02616029|Secondary|Percentage of Participants With Emergence of New Mutations in HIV-1 Reverse Transcriptase and Integrase|This outcome measure was planned to be assessed for any participant with any post Day 1 sample with HIV-1 RNA ≥ 50 copies/mL.|Day 1 up to 48 weeks|||||||
2563954|NCT02616029|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 as Defined by Pure Virologic Response (PVR)|The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 12 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL followed by discontinuation from the study.|Week 12|The Full Analysis Set included all the randomized participants who received at least one dose of study drug and excluded participants with any major protocol violations.|||percentage of participants|||Number
2563955|NCT02615990|Secondary|Number of Patients Discharged From Hospital to an Acute Rehabilitation Facility|The number of participants discharged to am acute rehabilitation facility will be counted and presented as a percentage of the total participants in that arm.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563956|NCT02615990|Secondary|Number of Patients Discharged From Hospital to a Long Term Care Facility|The number of participants discharged to a long term care facility will be counted and presented as a percentage of the total participants in that arm.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563957|NCT02615990|Secondary|Number of Patients Discharged From Hospital to Skilled Nursing Facility|The number of participants discharged to a skilled nursing home will be counted and presented as a percentage of the total participants in that arm.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563958|NCT02615990|Secondary|Number of Patients Discharged From Hospital to Home|The number of participants discharged to their home will be counted and presented as a percentage of the total participants in that arm.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563959|NCT02615990|Secondary|Mid-leg Muscle Circumference|Mid-leg muscle circumference will be measure using a metric tape measure at hospital admission and again just prior to discharge. Data will be presented as the change in muscle circumference (cm) over time.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563960|NCT02615990|Secondary|Independent Ambulation|The number of hospital days required for the participant to regain independent ambulation (the ability to walk 5 meters unassisted) with be measured and presented as total days.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563961|NCT02615990|Secondary|Assessment of Participant Mobility|The ICU Mobility Scale ranks a participant's mobility on a scale of 0-32, were a score of zero is a completely non-mobile individual and a score of 32 is a fully ambulatory individual. Data will be collected at the time of discharge. The data are presented as units on a scale.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563962|NCT02615990|Secondary|Fall Risk|Participant fall risk will be determined prior to discharge using the Berg Balance Scale to assess impairment of balance function through the completion of several functional tasks. The data are presented as units on a scale. The higher the number the lower the fall risk.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563963|NCT02615990|Secondary|Measure of Muscle Power|The Muscle Research Council Muscle Scale will be used to determine actual muscle power generation vs the anticipated power generation prior to discharge. Total score: 0 - 5, 5 is normal muscle function. Data are presented as units on a scale.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563964|NCT02615990|Secondary|Measure of Physical Capacity|Kansas University Hospital Physical Therapy Acute Care Functional Outcome Tool will be utilized to assess the participant's overall physical function prior to discharge. . Total score: 0 - 32, usually divided by 25%, 50%, >75% (minimum, moderate, maximum functionality). The higher the score, the great physical function the participant has.|At discharge (up to 1 year)|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563965|NCT02615990|Secondary|Incidence of Catheter Disruption|Incidence of unplanned removal/displacement of lines/tubes/catheters. Data will be presented as the number of disruptions per participant per group.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563966|NCT02615990|Secondary|Incidence of Physical Instability|Incidence of physical instability with be calculated as the number of falls per participant while hospitalized. Data will be presented as the number of falls per participant per group.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563967|NCT02615990|Secondary|Incidence of Pressure Ulcers|Incidence of pressure ulcers determined by physical observation. Total incidence will be compared between groups and presented as a total count of pressure ulcer diagnoses per group.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563968|NCT02615990|Secondary|Incidence of Deep Vein Thrombosis (DVT)|Incidence of DVT with be determined based on clinical symptoms to include pain and positive duplex ultrasound or other diagnostic tool|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563984|NCT02615535|Secondary|Change in Cognitive and Affective Mindfulness Scale-Revised|Subjects answer questions regarding mindfulness on a Likert Scale from 1-4. There are twelve questions total. Scores range from 4-48. Higher scores mean a better outcome.|baseline and six weeks||||score on a scale||Standard Error|Mean
2563969|NCT02615990|Secondary|Incidence of Urinary Tract Infections While Hospitalized|Incidence of urinary tract infection during hospitalization will be determined by clinical symptoms to include temperature of > 100.8 degrees F, WBC> 12000 WBC/MM3, patient complaints of pain, positive urine culture. Total incidence will be compared between groups and presented as a total count of urinary tract infection diagnoses per group.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563970|NCT02615990|Secondary|Incidence of Pneumonia While Hospitalized|Incidence of pneumonia while hospitalized will be determined by clinical symptoms to include temperature >100.8 degrees F, WBC>12,000 WBC/mm3 , PaO2/Fio2 ratio < 300 mmHg, positive respiratory culture for organisms and chest x-ray indicative of pneumonia. Total incidence will be compared between groups and presented as a total count of pneumonia diagnoses per group.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563971|NCT02615990|Secondary|Hospital Length of Stay|The duration of hospitalization will be measured and compared between groups. Data will be presented as mean number of days the participant is hospitalized.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563972|NCT02615990|Secondary|ICU Length of Stay|The duration of stay in the Trauma ICU will be measured and compared between groups. Data will be presented as mean number of days in the ICU.|Up to three months|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563973|NCT02615990|Primary|Orthostatic Tolerance During Ambulation|Rapid decreases in blood pressure are a common clinical challenge when trauma patients go from standing to full ambulation. Changes in blood pressure will be compared between groups to determine if verticalization with an ERIGO Pro tilt table will alleviate the drop in blood pressure more quickly than standard of care. Participants will have their blood pressure measured upon initial unassisted standing and then during each treatment session there after until discharge. Data will be presented as the number of days of treatment required to achieve blood pressure homeostasis during the positional change from standing to full ambulation.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563974|NCT02615990|Primary|Orthostatic Tolerance During Verticalization|Rapid decreases in blood pressure are a common clinical challenge when trauma patients go from lying down to standing. Changes in blood pressure will be compared between groups to determine if verticalization with an ERIGO Pro tilt table will alleviate the drop in blood pressure more quickly than standard of care. Participants will have their blood pressure measured upon initial verticalization after injury and at each treatment session there after until they achieve ambulation (the ability to move without assistance). Data will be presented as the number of days of treatment required to achieve blood pressure homeostasis during the positional change from lying to standing.|Up to one year|ERIGO Pro manufacture requested the device be returned before any subject completed the protocol||||||
2563975|NCT02615743|Secondary|Change in Child Asthma Control Tool Score (cACT) From Baseline to End of Intervention Period.|The difference in the change of cACT score from first study visit to the third study visit will be compared between the two study groups. Asthma Control Test (ACT) provides a numerical score to determine if asthma symptoms are well controlled. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well controlled asthma.|30 days|There are only 15 participants in the intervention group and 17 in the control group due to loss to follow up.|||units on a scale||Standard Deviation|Mean
2563976|NCT02615743|Secondary|Adherence|Percent adherence will be calculated as observed medication actuations from electronic adherence monitors over expected use (the latter is = prescribed daily regimen number of observation days)|30 days|There are only 15 participants in the intervention group and 17 in the control group due to loss to follow up.|||percent adherence||95% Confidence Interval|Mean
2563977|NCT02615743|Primary|Acceptability|"The rating of the monitoring device will be compared between groups based on responses to a questionnaire asking about acceptability and preferences to determine if there is a difference in the favorability We determined this by the number of participants who found text message reminders helpful to avoid missing doses. After 30 days caregivers of control group participants were given the option to receive daily text messages; they were asked about acceptability 30 days later."|30 days (intervention group) 60 days (control group)|There were 6 participants missing from the intervention group due to loss to followup. There were only 5 caregivers of participants in the control group who agreed to receive daily text messages.|||Participants|||Count of Participants
2563978|NCT02615743|Primary|Comparison of Number and Percentage of Patients That Use Monitoring Device Over 30 Days (Feasibility)|The number and percentage of patients that continue to use the monitoring device throughout the month will be compared between the intervention and control groups.|30 days||||Participants|||Count of Participants
2563979|NCT02615717|Secondary|Beck Anxiety Inventory (BAI)|Self-report measure of 20 symptoms of anxiety Range: 0-60 all items summed Higher score indicates higher severity|within three days||||units on a scale||Standard Deviation|Mean
2563980|NCT02615717|Secondary|Patient Health Questionnaire (PHQ-9)|Self-report measure of 9 symptoms related to depression Range: 0-27, all items summed Higher score indicates higher severity|within three days||||units on a scale||Standard Deviation|Mean
2563981|NCT02615717|Secondary|PTSD Checklist (PCL-5)|Self-report of PTSD symptom severity Scale range: 0-80 Total score utilized, all items summed. Higher score indicates higher severity.|within three days||||units on a scale||Standard Deviation|Mean
2563982|NCT02615717|Primary|Clinician-Administered PTSD Scale (CAPS-5)|Assesses symptoms and severity of Posttraumatic Stress Disorder Range: 0-80; total score utilized. Higher values indicate higher severity Subscales are summed to create a total score; subscales made up of different facets of PTSD.|within three days||||units on a scale||Standard Deviation|Mean
2563983|NCT02615535|Secondary|Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device|"Change in percent Calm as determined by Muse device. Equations behind this algorithm to determine Calm are proprietary and were not shared by the device manufacturer. Ranges from 0% to 100%. Higher scores mean a better outcome."|baseline and at six weeks||||"percentage of Calm"||Standard Error|Mean
2566433|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Glucose||Baseline, Week 24|Participants with measurements at given time point.|||mmol/L||Standard Deviation|Mean
2563987|NCT02615535|Secondary|Change in Trail Making Test|Subjects are asked to sequence numbers and letters represented on a page as quickly as then can. Results are measured in seconds, ranging from 0 (hypothetically) to an infinite number (hypothetically). Results are scaled from 1 to 19. Lower scores mean a better outcome.|baseline and six weeks||||units on a scale||Standard Error|Mean
2563988|NCT02615535|Secondary|Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding|A subject is provided with a key matching nine numbers to nine unique symbols. Numbers are then provided in random order and subjects have 120 seconds to match as many numbers with symbols as possible. All correct responses are scored. Scores range from 0 to 135. Scores are later scaled from 1 to 19. Higher scores mean a better outcome.|baseline and six weeks||||units on a scale||Standard Error|Mean
2563989|NCT02615535|Secondary|Change in Wechsler Adult Intelligence Scale-IV Digit Span|Tests participants digit span, repeating forward sequences of digits from 2 to 8. Scale ranges from 0 to 16. Higher scores mean a better outcome.|baseline and six weeks||||units on a scale||Standard Error|Mean
2563990|NCT02615535|Primary|Change in Neurobehavioral Symptom Inventory|Measures common symptoms after head injury. This scales ranges from 0-4 on 22 items, for a minimum score of 0 and a maximum score of 88. Higher scores mean a greater severity of symptoms.|baseline and six weeks||||units on a scale||Standard Error|Mean
2563991|NCT02615470|Other Pre-specified|The Level of Sustainability of Immunization Services|Change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy from 12 Months Pre- to 12 Months Post-Intervention. A representative of each pharmacy unit reported vaccine doses.|24 months|The unit of analysis was the pharmacy. A representative from each pharmacy unit reported the results. Results presented were collected 12 months after the intervention ended. Not all pharmacies that completed the 6 months survey completed the 12 months survey.|||vaccine doses|Pharmacy|Inter-Quartile Range|Median
2563992|NCT02615470|Secondary|Number of Strategies Implemented to Promote Immunization Activities|During the study, pharmacist-technician pairs engaged in on-going strategies used to advertise, market and assess non-seasonal immunization service processes. Of the total of 10 strategies possible, each pair selected strategies that they implemented. Results were reported by a representative from each pharmacy unit.|6 months|The unit of analysis was the pharmacy, a representative of each pharmacy unit reported the outcome. Two of the enhanced pharmacy did not provide responses regarding strategies to promote immunization activities.|||Process activities engaged|Pharmacy|Inter-Quartile Range|Median
2563993|NCT02615470|Primary|Number of Herpes Zoster and Pneumococcal Vaccinations Administered|The change in the number of pneumococcal and herpes zoster vaccinations administered in pharmacy during the 6-month intervention period from the 6-month baseline.|6 months|The data was reported by the pharmacy unit; participants are part of the pharmacy unit.|||vaccine doses|Pharmacy|Inter-Quartile Range|Median
2563994|NCT02615145|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and/or Pregnancies|An adverse event (AE) is defined as any untoward medical occurrence. If an AE meets any of the following criteria, it is considered serious: results in death, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in significant disability/incapacity, or is an important medical event. TEAEs are defined as any reported event that begins or worsens in severity after initiation of study drug through 30 days post-study drug dosing.|up to 30 days post treatment (treatment period was 12 weeks or 24 weeks)|Safety Population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN (the prescribed ABBVIE REGIMEN was known). Pregnancy data presented for female participants only.|||Participants|||Count of Participants
2563995|NCT02615145|Secondary|Change From Baseline Over Time in WPAI: Total Activity Impairment|"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total activity impairment indicates the percentage of general (non-work) activity impairment due to health problems."|Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT|Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (the prescribed ABBVIE REGIMEN was known). Overall: participants with a measurement at Baseline; data rows = participants with a measurement at Baseline and given time point.|||percentage impairment of activity||Standard Deviation|Mean
2563996|NCT02615145|Secondary|Change From Baseline Over Time in WPAI: Total Work Productivity Impairment|"The WPAI Hepatitis C V2.0 is an HCV specific questionnaire used to measure work absenteeism, work presenteeism, and daily activity impairment. Respondents were asked about time missed from work and time while at work during which productivity was impaired in the past seven days. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity.~Total work productivity impairment indicates the percentage of overall work impairment due to health problems."|Baseline, EoT (treatment period was 12 or 24 weeks),12 and 24 weeks after EoT|Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (the prescribed ABBVIE REGIMEN was known). Overall: participants with a measurement at Baseline; data rows = participants with a measurement at Baseline and given time point.|||percentage of overall work impairment||Standard Deviation|Mean
2563997|NCT02615145|Secondary|Change From Baseline to EoT in PAM-13 Questionnaire|The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Scores range from 0 to 100. Higher scores indicate a higher level of knowledge, skill and confidence.|Baseline, EoT (treatment period was 12 or 24 weeks)|Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known). Participants with a measurement at given time point.|||score on a scale||95% Confidence Interval|Least Squares Mean
2564039|NCT02614469|Secondary|Safety Assessment: Adverse Events|Number of participants with adverse events after study drug administration|Up to 10 days after first study drug administration at Day 1 of Period 1||||participants|||Number
2563998|NCT02615145|Secondary|Change From Baseline in FACIT-F Scale Over Time|The FACIT-F Scale is a 13-item questionnaire that assesses self-reported fatigue during the past 7 days and its impact upon daily activities and function. Scores range from 0 - 100, with higher scores indicating a lesser degree of fatigue.|Baseline, EoT (treatment period was 12 or 24 weeks), 12 and 48 weeks after EoT|Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known). Participants with a measurement at given time point.|||score on a scale||95% Confidence Interval|Least Squares Mean
2563999|NCT02615145|Secondary|Percentage of Planned Duration of ABBVIE REGIMEN and RBV Taken|Planned duration of treatment was 12 or 24 weeks.|Up to Week 12 or Week 24|Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known). Participants taking specified study drug with non-missing data.|||percentage of planned treatment duration||Standard Deviation|Mean
2564000|NCT02615145|Secondary|Mean Duration of of ABBVIE REGIMEN and RBV Taken|Documented by participant interview and/or participant diary.|Up to Week 12 or Week 24|Safety Population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN (the prescribed ABBVIE REGIMEN was known) and had an assessment.|||days||Standard Deviation|Mean
2564001|NCT02615145|Secondary|Percentage of Participants Taking ≥ 1 Co-Medication||up to post-treatment Week 48 (treatment period was 12 or 24 weeks)|Safety Population: all enrolled participants who received at least one dose of the ABBVIE REGIMEN (the prescribed ABBVIE REGIMEN was known).|||percentage of participants|||Number
2564002|NCT02615145|Secondary|Percentage of Participants With ≥ 1 Comorbidity and/or Co-Infection||up to post-treatment Week 48 (treatment period was 12 or 24 weeks)|Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known).|||percentage of participants|||Number
2564003|NCT02615145|Secondary|Change From Baseline in PRISM Over Time|"PRISM is a visual quantitative method to assess the perceived burden of suffering due to illness. The distance between the center of the self (yellow disk) and the illness disk (red disk) is called self-illness separation (SIS) and is measured in cm (range is 0 - 27). The smaller the distance, the higher the burden of suffering."|Baseline, 12 and 48 weeks after EoT (treatment period was 12 or 24 weeks)|Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known). Participants with a measurement at given time point.|||cm||95% Confidence Interval|Least Squares Mean
2564004|NCT02615145|Secondary|Percentage of Participants With Sustained Virological Response 48 Weeks After EoT (SVR48)|SVR48 is defined as participants with HCV RNA < 50 IU/mL 48 weeks after EoT.|48 Weeks After EoT (treatment period was 12 or 24 weeks)|Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known) with sufficient follow-up data regarding SVR48.|||percentage of participants|||Number
2564005|NCT02615145|Secondary|Percentage of Participants With Sustained Virological Response 24 Weeks After EoT (SVR24)|SVR24 is defined as HCV RNA < 50 IU/mL 24 Weeks After EoT.|24 Weeks After EoT (treatment period was 12 or 24 weeks)|Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known) with sufficient follow-up data regarding SVR24.|||percentage of participants|||Number
2564006|NCT02615145|Secondary|Percentage of Participants With Rapid Virological Response at Week 4 (RVR4)|RVR4 is defined as participants with HCV RNA < 50 IU/mL at Week 4.|Week 4|Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known).|||percentage of participants|||Number
2564007|NCT02615145|Secondary|Number of Participants With On-Treatment Virological Failure or Relapse|"The number of participants meeting the following SVR12 non-response categories:~On-treatment virological failure (breakthrough) defined >= 1 documented HCV RNA < 50 IU/mL followed by HCV RNA >= 50 IU/mL during treatment or failure to suppress (each measured on-treatment HCV RNA value >= 50 IU/mL)~Relapse defined as HCV RNA < 50 IU/mL at EoT followed by HCV RNA >= 50 IU/mL post-treatment in participants who completed treatment (<= 7 days shortened)."|Up to post-treatment Week 12 (treatment period was 12 or 24 weeks)|Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known). Participants with non-response 12 weeks after EoT.|||Participants|||Count of Participants
2564008|NCT02615145|Secondary|Percentage of Participants With Virological Response at End of Treatment (EoTR)|Virological response is defined as HCV RNA < 50 IU/mL. End of Treatment (EoT) is defined as the last intake of ABBVIE REGIMEN or RBV.|EoT, (treatment period was 12 weeks or 24 weeks)|Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known).|||percentage of participants|||Number
2564009|NCT02615145|Primary|Percentage of Participants With Sustained Virologic Response (SVR12)|SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (< 50 IU/mL) 12 weeks after the last actual dose of the ABBVIE REGIMEN.|12 weeks after the last dose of study drug (treatment period was 12 or 24 weeks)|Core Population: Participants who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype; the prescribed ABBVIE REGIMEN was known) with sufficient follow-up data regarding SVR12.|||percentage of participants|||Number
2564010|NCT02614924|Secondary|Intubation Time||up to 10 minutes||||seconds||Inter-Quartile Range|Median
2564011|NCT02614924|Primary|Total Time Taken to Complete the Procedure of Awake Intubation||up to 20 minutes||||seconds||Inter-Quartile Range|Median
2564012|NCT02614898|Secondary|Incidence Of Plasma Exchange And Plasma Infusion (PE/PI)|"The number of occurrences of PE/PI per participant-years was calculated and summarized by treatment status.~The study was terminated with only 20% of the planned enrollment and due to the subsequent loss of funding for the program, the samples collected for outcome measure assessment could not be analyzed to generate summary-level data. All participants enrolled in ECU-aHUS-403 were concurrently enrolled in protocol M11-001, and their data will be included in the analyses for M11-001."|Baseline, 24 Months|All enrolled participants. The study was terminated with only 20% of the planned enrollment; because the program lost funding, samples collected could not be analyzed to generate summary-level data. All participants enrolled in ECU-aHUS-403 were concurrently enrolled in protocol M11-001, and their data will be included in the analyses for M11-001.||||||
2564013|NCT02614898|Secondary|Change From Baseline To 24 Months In Estimated Glomerular Filtration Rate (eGFR)|"Change in estimated eGFR over time using the chronic kidney disease-epidemiology (CKD-EPI) formula.~The study was terminated with only 20% of the planned enrollment and due to the subsequent loss of funding for the program, the samples collected for outcome measure assessment could not be analyzed to generate summary-level data. All participants enrolled in ECU-aHUS-403 were concurrently enrolled in protocol M11-001, and their data will be included in the analyses for M11-001."|Baseline, 24 Months|All enrolled participants. The study was terminated with only 20% of the planned enrollment; because the program lost funding, samples collected could not be analyzed to generate summary-level data. All participants enrolled in ECU-aHUS-403 were concurrently enrolled in protocol M11-001, and their data will be included in the analyses for M11-001.||||||
2564014|NCT02614898|Primary|Rate Of Thrombotic Microangiopathy (TMA) Manifestations During Eculizumab Treatment Compared To Off-Treatment|"A TMA manifestation was defined as one of following: Hematologic or renal events due to aHUS; extra-renal clinical signs and symptoms of aHUS; tissue (for example, kidney transplant) biopsy demonstrating TMA due to aHUS.~The study was terminated with only 20% of the planned enrollment and due to the subsequent loss of funding for the program, the samples collected for outcome measure assessment could not be analyzed to generate summary-level data. All participants enrolled in ECU-aHUS-403 were concurrently enrolled in protocol M11-001, and their data will be included in the analyses for M11-001."|Baseline, 24 Months|All enrolled participants. The study was terminated with only 20% of the planned enrollment; because the program lost funding, samples collected could not be analyzed to generate summary-level data. All participants enrolled in ECU-aHUS-403 were concurrently enrolled in protocol M11-001, and their data will be included in the analyses for M11-001.||||||
2564015|NCT02614729|Secondary|Perceived Desire to Eat|"Questionnaires assessing desire to eat will be completed throughout each of the 12-hour testing days (which are separated by 3-4 weeks). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The scale is 0 to 100mm. The questions are worded in the following manner how strong is your feeling of with anchors of not at all (indicated at 0 mm) to extremely (indicated at 100 mm). All measures are reported at area under the curve for 0 to 630 min."|5 months||||Total Desire to Eat AUC (mm*630 min)||Standard Error|Mean
2564016|NCT02614729|Secondary|Perceived Prospective Food Consumption|"Questionnaires assessing prospective food consumption will be completed throughout each of the 12-hour testing days (which are separated by 3-4 weeks). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The scale is 0 to 100mm. The questions are worded in the following manner how strong is your feeling of with anchors of not at all (indicated at 0 mm) to extremely (indicated at 100 mm). All measures are reported at area under the curve for 0 to 630 min."|5 months||||Total PFC AUC (mm*630 min)||Standard Error|Mean
2564017|NCT02614729|Secondary|Perceived Hunger|"Questionnaires assessing hunger will be completed throughout each of the 12-hour testing days (which are separated by 3-4 weeks). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The scale is 0 to 100mm. The questions are worded in the following manner how strong is your feeling of with anchors of not at all (indicated at 0 mm) to extremely (indicated at 100 mm). All measures are reported at area under the curve for 0 to 630 min."|5 months||||Total Fullness AUC (mm*630 min)||Standard Error|Mean
2564018|NCT02614729|Secondary|Perceived Alertness|Alertness will be assessed during each of the 12-hour testing days (which are separated by 3-4 weeks) using the Profile of Mood States 2nd Edition (POMS2) with sub-categories of perceived vigor. POM2 is a self-report measure that allows for the quick assessment of transient, fluctuating feelings, and enduring affect states. There are 35 items. Items are rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The Alertness (Vigor-Activity) scale score indicates the extent to which individual felt alert (vigorous and/or energetic); the higher are her positive feelings and/or energy, the greater is her score (i.e., a low score indicates relatively fewer positive feelings and/or low energy). Ratings on this scale yielded a T-score of 25 (95% CI =18-32), which is ranked at the 1st percentile, and falls within the Very Low score range. The T scores were then used to calculate area under the curve.|5 months||||Total AUC (T-score*min)||Standard Error|Mean
2564019|NCT02614729|Secondary|Reaction Time as a Measure of Cognitive Performance Assessed Using the Stroop Test|Cognitive function will be assessed during each of the 12-hour testing days using CNS Vital Signs, a validated computerized assessment. This system contains a core battery of tasks. Reaction Time is the outcome of interest measured with the Stroop Test. In the first part, the words RED, YELLOW, BLUE, & GREEN (printed in black) appear at random on the screen, & the participant presses the space bar as soon as the test subject sees the word. In the second part, the words RED, YELLOW, BLUE, & GREEN appear on the screen, printed in color. The participant is asked to press the space bar when the color of the word matches what the word says. In the third part, the words RED, YELLOW, BLUE, & GREEN appear on the screen, printed in color. The participant is asked to press the space bar when the color of the word does not match what the word says. Reaction time is in milliseconds.|5 months||||ms||Standard Error|Mean
2564020|NCT02614729|Secondary|Perceived Fullness|"Questionnaires assessing fullness will be completed throughout each of the 12-hour testing days (which are separated by 3-4 weeks). The questionnaires contain validated visual analog scales (VAS) incorporating a 100 mm horizontal line rating scale for each response. The scale is 0 to 100mm. The questions are worded in the following manner how strong is your feeling of with anchors of not at all (indicated at 0 mm) to extremely (indicated at 100 mm). All measures are reported at area under the curve for 0 to 630 min."|5 months||||Total Fullness AUC (mm*630 min)||Standard Error|Mean
2564022|NCT02614703|Primary|Total Number of Subjects With Neoplasia When Using Acetic Acid Chromoendoscopy Versus Standardized Random Biopsies.|Spray of Acetic Acid into the esophageal mucosa during routine esophageal biopsies for Barrett's esophagus surveillance increases the yield of neoplasia.|142 seconds|Thirty-one (31) patients entered the preliminary data analysis. Of these 31 patients, twenty (20) were classified as SSBE, and eleven (11) patients as Long Segment BE (LSBE). These 31 patients were confirmed to have Barrett's esophagus via biopsy and were randomized (Acetic Acid n=20, Control n=11)|||participants|||Number
2564023|NCT02614690|Other Pre-specified|Average Time for First Follow-up Appointment|Average time from reduction and casting to the first follow-up visit.|1-2 weeks||||days||Standard Deviation|Mean
2564024|NCT02614690|Other Pre-specified|Number of Participants With Different Cast Complications||Day 1 to day 56||||participants|||Number
2564025|NCT02614690|Other Pre-specified|Number of Patients With Different Fracture Treatments||4 weeks||||participants|||Number
2564026|NCT02614690|Other Pre-specified|Pain Levels|"Pain levels were assessed using the validated Wong-Baker FACES visual pain rating scale. This scale presents a total of 6 options for pain- none, 1, 2, 3, 4, and 5- with 5 corresponding to the greatest amount of pain. During the analysis it was decided to group these into 5 categories: No pain which was equal to those selecting none, Mild corresponding to those selecting 1, Moderate pain corresponding to those that selected either 2 or 3, and Severe pain corresponding to those that selected either 4 or 5. Patients with no response were placed into the group no response."|one week||||Participants|||Count of Participants
2564027|NCT02614690|Other Pre-specified|Number of Participants With Different Fracture Characteristics||Less than 1 day||||Participants|||Count of Participants
2564028|NCT02614690|Other Pre-specified|Cast Index|The cast index is a measure of potential for cast failure described by Chess et al. in 1994. The cast index is calculated as the sagittal width measure divided by the coronal cast width measure at the fracture site. A ratio between these measures of 0.7 or greater for pediatric forearms is considered acceptable. For each patient in this study the cast index was calculated as described above. The average cast index for each of the 3 groups was then presented as the final result.|Immediately after cast application (<1 day)||||ratio||Standard Deviation|Mean
2564029|NCT02614690|Primary|Complication Rate of the Cast Type|This data will be able to help physicians and ER personnel help this patient population with the least number of cast complications and therefore allow for a more efficient use of resources since cast modifications could be minimized. Metrics used to characterize complications are the radiographic union used to determine speed of healing and the number of unplanned ER or clinic visits for cast modifications.|<60 days corresponding to total study time and consistent with outcome 6||||participants|||Number
2564030|NCT02614586|Secondary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)||Part 2: Day 1 of Intervention Period 1 up to Day 21|Part 2 was not initiated because it was not possible to calculate an ICC due to the magnitude of the intrasubject variability in relation to the intersubject variability.||||||
2564031|NCT02614586|Primary|Change From Baseline in P50 Ratio S2/S1 at Central (Cz) Electrode Following Administration of TAK-058|Participants were planned to check for P50 gating ratio. Stimulus signal of 90 decibel pulses of 0.1 millisecond (msec) was to be generated and recorded the event-related potential waveforms. 32 pairs of auditory clicks were to be presented every 10 seconds, with a 500 msec interclick interval. S1 is defined as the conditioning P50 wave with the most positive peak between 30 and 90 msec after the conditioning stimulus. S2 is defined as the test P50 wave with the positive peak after the test stimulus that was closest in latency to the conditioning P50. Amplitude is the difference between the positive peak and the preceding negative trough for both waves. The data from the vertex (Cz site) was to be collected and the P50 gating ratio (S2/S1) was to be calculated as the ratio of the test P50 amplitude to the conditioning P50 amplitude.|Part 2: Day 1 pre-dose and at multiple time points (up to 2 hours) post-dose in each period.|Part 2 was not initiated because it was not possible to calculate an ICC due to the magnitude of the intrasubject variability in relation to the intersubject variability.||||||
2564032|NCT02614560|Secondary|Overall Survival|Defined as the time from the day of alloSCT to the date of death due to any cause.|Approximately 96 weeks||||weeks||Full Range|Median
2564033|NCT02614560|Secondary|Duration of Response|Defined as the time from the start of the first documented complete response (CR) or complete remission with incomplete blood count recovery (CRi) to the documentation of relapse or death due to any cause.|9 weeks|Part A (pre-alloSCT) only|||weeks||Full Range|Median
2564034|NCT02614560|Secondary|Best Response of CR or CRi|Percentage of patients who achieved a best response of CRi (complete remission with incomplete blood count recovery) or CR (complete remission)|9 weeks|Part A (pre-alloSCT) only|||Participants|||Count of Participants
2564035|NCT02614560|Primary|Rate of MRD Negativity|Rate of MRD (minimal residual disease) negativity at Day -1 (1 day prior to transplant) and Day 30 post-transplant (Part A only)|30 days|All treated patients set, pre-allo cohort|||Percentage of participants||95% Confidence Interval|Number
2564036|NCT02614560|Primary|1-year Survival Rate|1-year survival rate estimated using Kaplan-Meier methods The start date for overall survival is the day of alloSCT.|12 months|All treated patients set|||percentage of participants||95% Confidence Interval|Number
2564037|NCT02614560|Primary|Incidence of Laboratory Abnormalities|Number (count) of participants that experienced a Grade 3 or higher laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.|Approximately 1 year||||Participants|||Count of Participants
2564038|NCT02614560|Primary|Incidence of Adverse Events|AE: Adverse events; TEAE: Treatment-emergent adverse event. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event. An AE is considered serious if it was fatal, life threatening, required hospitalization, was disabling/incapacitating, resulted in a birth defect or congenital anomally, or was otherwise considered to be medically significant.|Approximately 1 year||||Participants|||Count of Participants
2564041|NCT02614469|Primary|Baseline Corrected T1/2: Baseline Corrected Apparent Terminal Half-life|Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2).|-12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose|Baseline Corrected T 1/2 values for 2 subjects were not able to be calculated based on the serum concentration-time curve of these subjects.|||hr||Standard Deviation|Mean
2564042|NCT02614469|Primary|Baseline Corrected Tmax: Baseline Corrected Time of Maximum Serum Concentration|Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2).|-12 to 0 h pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, and 48 hrs post-dose||||hr||Full Range|Median
2564043|NCT02614469|Primary|Baseline Corrected AUC (0-inf): Baseline Corrected Area Under the Serum Concentration-time Curve From Time 0 to Infinity|Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2).|-12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, and 48 hrs post-dose|Baseline Corrected AUC (0-inf) values of 2 subjects were not able to be calculated based on the serum concentration-time curve of these subjects.|||mg*hr/dL||Standard Deviation|Mean
2564044|NCT02614469|Primary|Baseline Corrected AUC (0-t): Baseline Corrected Area Under the Serum Concentration-time Curve From Time 0 to Time t (Time of Last Quantifiable Serum Concentration)|Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2). Negative concentrations were set to zero.|-12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose||||mg*hr/dL||Standard Deviation|Mean
2564045|NCT02614469|Primary|Baseline Corrected Cmax: Baseline Corrected Maximum Serum Concentration|Correction for individual endogenous urate levels was done by subtracting the individual mean endogenous baseline concentration prior to dosing from each post-dose concentration in the profile. The two samples collected at -12 h and 0 h (pre-dose) before the meal were used to measure the mean endogenous baseline concentrations in each dosing period (periods 1 and 2). Negative concentrations were set to zero.|-12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose||||mg/dL||Standard Deviation|Mean
2564046|NCT02614469|Primary|T1/2: Apparent Terminal Half-life||-12 to 0 pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose|T 1/2 of 1 subject was not able to be calculated based on the serum concentration-time curve of the subject.|||hr||Standard Deviation|Mean
2564047|NCT02614469|Primary|Tmax: Time of Maximum Serum Concentration||-12 to 0 hr pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose||||hr||Full Range|Median
2564048|NCT02614469|Primary|AUC (0-inf): Area Under the Serum Concentration-time Curve From Time 0 to Infinity||-12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose|AUC (0-inf) of 1 subject was not able to be calculated based on the serum concentration-time curve of the subject.|||mg*hr/dL||Standard Deviation|Mean
2564049|NCT02614469|Primary|AUC (0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t (Time of Last Quantifiable Plasma Concentration)||-12 to 0 hr pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48 hrs post-dose||||mg*hr/dL||Standard Deviation|Mean
2564050|NCT02614469|Primary|Cmax: Maximum Observed Serum Urate Concentration||-12 to 0 hrs pre-dose and 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hrs post-dose||||mg/dL||Standard Deviation|Mean
2564051|NCT02614287|Secondary|Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12|"The SQAAQ is a self-administered questionnaire that provides an assessment of ease of use and confidence with using a device to administer a subcutaneous injection of study drug. Participants will respond to questionnaire items using a 7-point Likert scale (from Strongly Disagree to Strongly Agree) shortly after the injection. If a caregiver administers the injection, the participants should be prepared to provide the caregiver's ratings of the questions.strongly agree & agree are considered as positive responses."|Baseline through Month 12|All randomized participants who switched from pre-filled syringe and received at least one dose of study drug by autoinjector.|||participants|Number of participant visits||Number
2564052|NCT02614287|Secondary|Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)|"The PSMQ-M is a self-rated scale which measures participants level of satisfaction with study medication.The scale has been modified for use in this study, assessing 3 items related to the clinical trial treatment over the past 4 weeks: satisfaction, preference, and side effects. Satisfaction responses range from very unsatisfied to very satisfied with the current treatment. Preference compares the current study medication to previous medications, with responses from much rather prefer my previous medication to much rather prefer the medication administered to me during the study."|Baseline through Month 12|All randomized participants who received at least one dose of study drug and had month 12 PSMQ-M measurement.|||percentage of Participants|||Number
2564063|NCT02614287|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab|Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab|Baseline through Month 12|Zero participants analyzed. AUC data was not collected as AUC was not pre-specified in protocol.||||||
2564108|NCT02614183|Secondary|Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days|"Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred.~Mean is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, baseline."|Baseline, Month 1 through Month 6|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.|||percentage of participants||Standard Error|Mean
2564053|NCT02614287|Secondary|Overall Mean Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1|"MSQv2.1 is a health status instrument,with a 4-week recall period, developed to address physical & emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family & friends, leisure time, productivity, concentration, energy, tiredness & feelings.It consists of 14 items addressing 3 domains:(1)Role Function-Restrictive (items 1-7);(2)Role Function- Preventive (items 8-11);&(3)Emotional Function (items 12-14).Response options range from none of the time (value 1) to all of the time (value 6), & are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items in that domain.After total raw score is computed for each domain & total score, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement."|Baseline, Month 1 through Month 12|"All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.~Overall mean is derived from the average of months 1 to 12.LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects."|||units on a scale||Standard Error|Least Squares Mean
2564054|NCT02614287|Secondary|Overall Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score|The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month.|Baseline, Month 1 through Month 12|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.|||units on a scale||Standard Error|Least Squares Mean
2564055|NCT02614287|Secondary|Overall Mean Patient Global Impression-Improvement (PGI-I) Score|"The Patient Global Impression of Improvement (PGI -I) scale is a participant-rated instrument that measures the participants own global impression of their symptom improvement. The participant was instructed as follows: Mark the box that best describes your migraine headache condition since you started taking this medicine. Response options were on a 7-point scale in which a score of 1 indicates that the participant's condition is very much better, a score of 4 indicates that the participant has experienced no change, and a score of 7 indicates that the participant is very much worse. Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline PGI-S, and baseline PGI-S by month as fixed effects."|Month 1 through Month 12|All randomized participants who received at least one dose of study drug and had at least one post baseline value.|||units on a scale||Standard Error|Least Squares Mean
2564056|NCT02614287|Secondary|Overall Mean Change From Baseline in the Frequency of Medication Use for the Acute Treatment of Migraines or Headaches|Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.|Baseline, Month 1 through Month 12|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.|||Medication Used Days per Month||Standard Error|Least Squares Mean
2564057|NCT02614287|Secondary|Percentage of Participants With Overall Reduction From Baseline ≥50% in Monthly Migraine Headache Days|"Migraine Headache Day: A calendar day on which a migraine headache or probable migraine headache occurred.~Overall percentage of participants with a given response rate were estimated from the generalized linear mixed models (GLIMMIX) model."|Baseline, Month 1 through Month 12|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline value.|||percentage of Participants|||Number
2564058|NCT02614287|Secondary|Overall Mean Change From Baseline in the Number of Headache Days|"Headache Day: A calendar day on which any type of headache occurred (including migraine, probable migraine, and non-migraine headache).~Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects."|Baseline, Month 1 through Month 12|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline Value.|||Headache Days per Month||Standard Error|Least Squares Mean
2564059|NCT02614287|Secondary|Overall Mean Change From Baseline in the Number of Migraine Headache Days (MHD)|MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 12 from MMRM model. Least squares mean (LSMean) was calculated using mixed model repeated measures (MMRM) model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.|Baseline, Month 1 through Month 12|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline value.|||Migraine Headache Days per Month||Standard Error|Least Squares Mean
2564060|NCT02614287|Secondary|Percentage of Participants Developing Anti-Drug Antibodies to Galcanezumab|"A Treatment Emergent Anti-drug Antibody (TE ADA) evaluable participant is considered to be TE ADA+ if the participant has at least one post-baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post-baseline result of ADA Present with titer >= 1: 20 (treatment-induced).~There were 6 participants in the 120 mg arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for safety analysis."|Month 1 through Month 12|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline evaluable data for TE ADA.|||Percentage of Participants|||Number
2564061|NCT02614287|Secondary|Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)|Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)|Month 12|All randomized participants with measurable plasma concentration.|||ng/mL||Standard Deviation|Mean
2564064|NCT02614287|Primary|Percentage of Participants Who Discontinued Due to Adverse Event|"Adverse Event: Any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.~A summary of other non-serious AEs, and all SAE's, regardless of causality, is reported in the Adverse Events section."|Baseline through Month 12|All randomized participants who received at least one dose of study drug. There were 6 participants in the 120 mg group who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg group for AE analysis.|||Percentage of Participants|||Number
2564065|NCT02614274|Secondary|Patient Reported Survey to Assess Symptoms and Function in Daily Living Via IKDC (International Knee Documentation Committee) Subject Exam|International Knee Documentation Committee (IKDC). Each subscale is scored from 0-100, with 100 being no limitation with activities of daily living or sports activities and the absence of symptoms.|42 days||||units on a scale||Standard Deviation|Mean
2564066|NCT02614274|Secondary|Patient Reported Survey to Assess: Pain, Stiffness, and Physical Function in Patients With Hip and/or Knee Osteoarthritis (OA) Via WOMAC (Western Ontario and McMaster Universities Arthritis Index)|The Western Ontario and McMaster Universities Arthritis Index (WOMAC). A lower score indicates less severe symptoms, a higher score indicates more severe symptoms. The range of scores as is follows: 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Function.|42 days||||units on a scale||Standard Deviation|Mean
2564067|NCT02614274|Secondary|Patient Reported Opinions (About Their Knee) Via KOOS (Knee Injury and Osteoarthritis Outcome Score)|Knee injury and Osteoarthritis Outcome Score (KOOS). A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|42 days||||units on a scale||Standard Deviation|Mean
2564068|NCT02614274|Secondary|Patient Reported Quality of Life Via SF-36 (36-Item Short Form Health Survey) Improvement|"The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software.~Mean+-SD among of improvement is reported."|42 days||||units on a scale||Standard Deviation|Mean
2564069|NCT02614274|Primary|Urine Biomarkers|Urine will be assessed using a proprietary panel of biomarkers of inflammation.|42 days||||pg/ml||Standard Deviation|Mean
2564070|NCT02614274|Primary|Serum Biomarkers|Blood will be assessed using a proprietary panel of biomarkers of inflammation. Blood and urine were collected, processed, and analyzed using a proprietary panel of biomarkers using the Luminex system as previously described (Garner, et al; Roller, et al). In addition, serum hsCRP was analyzed.|42 days||||pg/ml||Standard Deviation|Mean
2564071|NCT02614261|Secondary|Serum Concentrations of Galcanezumab|Serum concentrations of Galcanezumab|Month 3|All randomized participants who received at least one dose of Galcanezumab and had measurable serum concentrations.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2564072|NCT02614261|Secondary|Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)|Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).|Month 3|All randomized participants who received at least one dose of study drug and had measurable plasma concentrations.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2564073|NCT02614261|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab|Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab.|Baseline through Month 3|Zero participants analyzed. AUC data was not collected as AUC was not pre-specified in protocol.||||||
2564074|NCT02614261|Secondary|Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab|A Treatment Emergent Anti-Drug Antibodies (TE ADA) evaluable participant is considered to be TE ADA+ if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post baseline result of ADA Present with titer >= 20.|Month 1 through Month 3|All randomized participants who received at least one dose of study drug and had at least one non-missing test result for ADA for each of the baseline period and the post baseline period.|||Participants|||Count of Participants
2564075|NCT02614261|Secondary|Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score|The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. LSMean was calculated using Analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, and baseline value as fixed effects.|Baseline, Month 3|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2564076|NCT02614261|Secondary|Overall Mean Change From Baseline in Headache Hours|Overall mean is derived from the average of months 1 to 3 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month,baseline, and baseline by month as fixed effects.|Baseline, Month 1 through Month 3|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline measurement.|||Headache Hours per Month||Standard Error|Least Squares Mean
2564181|NCT02613871|Secondary|Plasma HBV DNA Change From Baseline While on Treatment||Weeks 1, 2, 4, 8, and 12|Participants in Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2564077|NCT02614261|Secondary|Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score|"PGI-S scale is a participant-rated instrument that measures participants own global impression of their illness severity. The participant was instructed as follows: Considering migraine as a chronic condition, how would you rate your level of illness? Response options were from 1 (normal, not at all ill) to 7 (extremely ill). LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects."|Baseline, Month 3|All randomized participants who received at least one dose of study drug and had baseline and month 3 measurement.|||units on a scale||Standard Error|Least Squares Mean
2564078|NCT02614261|Secondary|Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache|"Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.~Overall mean is derived from the average of months 1 to 3 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month,baseline, and baseline by month as fixed effects."|Baseline, Month 1 through Month 3|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.|||Days Per Month||Standard Error|Least Squares Mean
2564079|NCT02614261|Secondary|Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role-function Restrictive Domain|"MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family & friends, leisure time, productivity, concentration, energy, tiredness & feelings. It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);&(3) Emotional Function (items 12-14).Response options range from none of the time (value 1) to all of the time (value 6),& are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items in that domain. After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement."|Baseline, Month 3|"All randomized participants who received at least one dose of study drug and had baseline and month 3 measurement.~LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects."|||units on a scale||Standard Error|Least Squares Mean
2564080|NCT02614261|Secondary|Number of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days|MHD: A calendar day on which a migraine headache or probable migraine headache occurred.|Baseline, Month 1 through Month 3|All randomized participants who received at least one dose of study drug and had baseline and month 3 measurement.|||Participants|||Count of Participants
2564081|NCT02614261|Primary|Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD)|"MHD: A calendar day on which a migraine headache or probable migraine headache occurred.~Overall mean is derived from the average of months 1 to 3 from mixed model repeated measures (MMRM) model. Least square(LS) Mean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects."|Baseline, Month 1 through Month 3|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.|||Migraine Headache Days per Month||Standard Error|Least Squares Mean
2564082|NCT02614222|Secondary|Undesired Muscle Weakness Measured Subjectively|Number of participants that report undesired muscle weakness. Undesired muscle weakness will be measured subjectively - whether patient unable to ambulate and/or requiring the use of an immobilizer.|During hospital stay (maximum 3 days)|This data was not collected for 6 (out of 27) participants.|||Participants|||Count of Participants
2564083|NCT02614222|Secondary|Incidence of Postoperative Nausea and Vomiting|Number of participants that reported postoperative nausea and vomiting|During hospital stay (maximum 3 days)|This data was not collected for 4 (out of 27) participants.|||Participants|||Count of Participants
2564084|NCT02614222|Secondary|Number of Patients That Needed Rescue Opioids||During hospital stay (maximum 3 days)|This data was not collected for 4 (out of 27) patients|||Participants|||Count of Participants
2564085|NCT02614222|Secondary|Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire|Patient satisfaction will be recorded in the hospital or via phone on post-op day 1, on a 10-point scale (10 being most satisfied), using a questionnaire.|Post-op day 1|This data was not collected for 5 (out of 27) participants.|||Units on a Scale||Standard Deviation|Mean
2564086|NCT02614222|Secondary|Number of Times Needle Needs Repositioning||Immediately following intervention (within 2 hours)|Data for this outcome measure was not collected.||||||
2564087|NCT02614222|Secondary|Number of Attempts|Number of instrument pricks before target is reached|Immediately following intervention (within 2 hours)|This data was not collected for 3 (out of 27) participants.|||Attempts||Standard Deviation|Mean
2564088|NCT02614222|Secondary|Clinician Rating of the Device|Clinician rates the device on a scale of 1-10. This also includes a questionnaire.|Immediately following intervention (within 2 hours)|Data for this outcome measure was not collected||||||
2564089|NCT02614222|Primary|Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block||Immediately after intervention (within 2 hours)||||Minutes||Standard Deviation|Mean
2564090|NCT02614196|Secondary|Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)|Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).|Month 6|"All randomized participants who had received at least one dose of study drug and had measurable plasma concentration.~As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups."|||ng/mL||Standard Deviation|Mean
2564091|NCT02614196|Secondary|Pharmacokinetics (PK): Serum Concentrations of Galcanezumab|Pharmacokinetics (PK): Serum Concentrations of Galcanezumab.|Month 6|"All randomized participants who received at least one dose of study drug and had measurable serum concentrations.~As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups."|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2564092|NCT02614196|Secondary|Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab|Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject has at least one post-baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post-baseline result of ADA present with titer >= 1: 20.|Month 1 through Month 6|All randomized participants who received at least one dose of study drug & had least one non-missing test result for ADA for each of the baseline period and the post-baseline period. As pre-specified in the analysis plan, outcome measures will not be reported for the ME2 arms/groups but only for the main global study arms/groups.|||percentage of participants|||Number
2564093|NCT02614196|Secondary|Mean Change From Baseline in the Migraine Disability Assessment Test (MIDAS) Total Score|"The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability.~LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors."|Baseline, Month 6|"All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.~As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups."|||units on a scale||Standard Error|Least Squares Mean
2564094|NCT02614196|Secondary|Overall Mean Change From Baseline in Headache Hours|Headache Hours is calculated as the total number of headache hours on which a headache occurred. Overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month and baseline MHD category.|Baseline, Month 1 through Month 6|"All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.~As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups."|||Headache Hours per Month||Standard Error|Least Squares Mean
2564095|NCT02614196|Secondary|Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) Rating|"The PGI-S scale is a participant-rated instrument that measures patients own global impression of their illness severity. The participant was instructed as follows: Considering migraine as a chronic condition, how would you rate your level of illness? Response options were from 1 (normal, not at all ill) to 7 (extremely ill). Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors."|Baseline, Month 4 through Month 6|"All randomized participants who received at least one dose of study drug and had baseline and post baseline value.~As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups."|||units on a scale||Standard Error|Least Squares Mean
2564096|NCT02614196|Secondary|Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache|"Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.~Overall mean is derived from the average of months 1 to 6 from MMRM model.LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed effects."|Baseline, Month 1 through Month 6|"All randomized participants who received at least one dose of study drug and had baseline and post baseline value.~As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups."|||Days per Month||Standard Error|Least Squares Mean
2564097|NCT02614196|Secondary|Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 Role Function Restrictive Domain|"MSQ v2.1 was developed to address physical & emotional limitations of specific concern to individuals with migraine.~It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);&(3) Emotional Function (items 12-14).Response options range from none of the time (value 1) to all of the time (value 6), & are reverse-recoded (value 6 to 1) before the domain scores are calculated.Total raw scores for each domain is the sum of the final item value for all of the items in that domain.After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement.~Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline by month & baseline MHD category as fixed factors."|Baseline, Month 4 through Month 6|"All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline value.~As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups."|||units on a scale||Standard Error|Least Squares Mean
2564098|NCT02614196|Secondary|Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75%, and 100% in Monthly Migraine Headache Days|"Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred.~Mean is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, baseline."|Baseline, Month 1 through Month 6|"All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.~As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups."|||percentage of participants||Standard Error|Mean
2564196|NCT02613481|Primary|Mean Rosenberg Self-Esteem Scale|Self reported self esteem measure Title: Rosenberg Self-Esteem Scale Scale of 1-4, scale design with higher score relating to worse outcome.|6 months post initial injection||||units on a scale||Standard Deviation|Mean
2564099|NCT02614196|Primary|Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days|"Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.~Migraine Headache : A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B):~A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia;~Overall mean is derived from the average of months 1 to 6 from mixed model repeated measures (MMRM) model. Least Square (LS) mean was calculated using mixed model repeated measures (MMRM) model with treatment, pooled country, month, and treatment by month, baseline, and baseline by month as fixed effects."|Baseline, Month 1 through Month 6|"All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.~As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups"|||Migraine Headache Days per Month||Standard Error|Least Squares Mean
2564100|NCT02614183|Secondary|Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)|Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).|Month 6|All randomized participants who had received at least one dose of study drug and had measurable plasma concentrations.|||ng/mL||Standard Deviation|Mean
2564101|NCT02614183|Secondary|Pharmacokinetics (PK): Serum Concentrations of Galcanezumab|Pharmacokinetics (PK): Serum Concentrations of Galcanezumab.|Month 6|All randomized participants who received at least one dose of study drug and had measurable serum concentrations.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2564102|NCT02614183|Secondary|Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab|Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject has at least one post-baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post-baseline result of ADA present with titer >= 1: 20.|Month 1 through Month 6|All randomized participants who received at least one dose of study drug and had least one non-missing test result for ADA for each of the baseline period and the post-baseline period.|||percentage of participants|||Number
2564103|NCT02614183|Secondary|Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score|"The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability.~LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors."|Baseline, Month 6|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.|||units on a scale||Standard Error|Least Squares Mean
2564104|NCT02614183|Secondary|Overall Mean Change From Baseline in Headache Hours|Headache Hours is calculated as the total number of headache hours on which a headache occurred. Overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month and baseline MHD category.|Baseline, Month 1 through Month 6|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.|||Hours per Month||Standard Error|Least Squares Mean
2564105|NCT02614183|Secondary|Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Rating|"The PGI-S scale is a patient-rated instrument that measures patients own global impression of their illness severity. The patient was instructed as follows: Considering migraine as a chronic condition, how would you rate your level of illness? Response options were from 1 (normal, not at all ill) to 7 (extremely ill). Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors."|Baseline, Month 4 through Month 6|All randomized participants who received at least one dose of study drug and had baseline and post baseline value.|||units on a scale||Standard Error|Least Squares Mean
2564106|NCT02614183|Secondary|Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache|"Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.~Overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed effects."|Baseline, Month 1 through Month 6|All randomized participants who received at least one dose of study drug and had baseline and post baseline value.|||Days||Standard Error|Least Squares Mean
2564107|NCT02614183|Secondary|Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 (v2.1) Role Function Restrictive Domain|"MSQ v2.1 was developed to address physical & emotional limitations of specific concern to individuals with migraine.~It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);&(3) Emotional Function (items 12-14).Response options range from none of the time (value 1) to all of the time (value 6), & are reverse-recoded (value 6 to 1) before the domain scores are calculated.Total raw scores for each domain is the sum of the final item value for all of the items in that domain.After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement.~Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline by month & baseline MHD category as fixed factors."|Baseline, Month 4 through Month 6|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.|||units on a scale||Standard Error|Least Squares Mean
2564197|NCT02613481|Primary|Mean Rosenberg Self-Esteem Scale|Self reported self esteem measure Title: Rosenberg Self-Esteem Scale Scale of 1-4, scale design with higher score relating to worse outcome.|3 months post initial injection||||units on a scale||Standard Deviation|Mean
2564109|NCT02614183|Primary|Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days|"Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.~Migraine Headache : A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B):~A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia;~Overall mean is derived from the average of months 1 to 6 from mixed model repeated measures (MMRM) model. Least Square (LS) mean was calculated using mixed model repeated measures (MMRM) model with treatment, pooled country, month, and treatment by month, baseline, and baseline by month as fixed effects."|Baseline, Month 1 through Month 6|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.|||Days||Standard Error|Least Squares Mean
2564110|NCT02614131|Secondary|Plasma Amyloid Beta (Aβ1-40 and Aβ1-42) Concentration Part B|Concentration of plasma amyloid beta 1-40 and 1-42, in participants with Mild Cognitive Impairment (MCI) or Alzheimer Disease, after multiple doses of LY2599666 administered subcutaneously.|Day 85: Pre-dose, 2, 4, 8, 12, 24, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 96, 120, 168, 216, 264, 336, 504, 672 hours post-dose (Part B)|All participants who received at least one dose of study drug in Part B and had evaluable Aβ1-40 or Aβ1-42 data.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2564111|NCT02614131|Secondary|Plasma Amyloid Beta1-40 (Aβ1-40 ) Concentration Part A|Concentration of plasma amyloid beta 1-40 in healthy participants after single dose of LY2599666 administered subcutaneously.|Day 1: Pre-dose and 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 504, 672 hours post-dose (Part A)|All participants who received at least one dose of study drug in Part A and had evaluable Aβ1-40 data.|||picograms per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2564112|NCT02614131|Secondary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 168 Hours (AUC 0-168) of LY2599666 Part B|Area Under the Concentration time versus curve from 0-168 hours after weekly dose of LY2599666 administered subcutaneously.|Day 85: Pre-dose, 2, 4, 8, 12, 24, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 96, 120, 168 hours post-dose (Part B)|All participants who received at least one dose of drug in Part B and had evaluable AUC data.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2564113|NCT02614131|Secondary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC 0-∞) of LY2599666 Part A|Area Under the Concentration versus Time Curve of zero to infinity (0 to ∞) after a single dose of LY2599666 administered subcutaneously.|Day 1: Pre-dose and 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 504, 672 hours post-dose (Part A)|All participants who received at least one dose of drug in Part A and had evaluable AUC data.|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2564114|NCT02614131|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2599666 Part B|PK: Cmax of LY2599666 after multiple doses administered subcutaneously.|Day 85: Pre-dose, 2, 4, 8, 12, 24, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 96, 120, 168, 216, 264, 336, 504, 672 hours post-dose (Part B)|All participants who received at least one dose of drug in Part B and had evaluable Cmax data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2564115|NCT02614131|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2599666 Part A|PK: Cmax of LY2599666 after a single dose administered subcutaneously.|Day 1: Pre-dose and 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 504, 672 hours post-dose (Part A)|All participants who received at least one dose of study drug in Part A and had evaluable Cmax data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2564116|NCT02614131|Primary|Number of Participants With One or More Serious Adverse Event (SAE) Considered by the Investigator to be Related to Study Drug Administration|Number of participants who experienced one or more treatment-emergent serious adverse events related to study treatment. A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline through 4 weeks (Part A) or 16 weeks (Part B )|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2564117|NCT02614079|Primary|Number of Participants With Positive Collision|Positive collision: 75% or greater decrease in amplitude from the baseline waveform. Centroparietal (CPz)-Popliteal Fossa (Fpz) cortical montage (images) will be used as primary montage to evaluate collision results.|Day 1|5 participants completed DSSEP testing after placement of SCS Trial leads.|||Participants|||Count of Participants
2564118|NCT02613910|Secondary|Titer of Human Anti-human Antibody|Blood samples for HAHA titer analysis were planned to be collected at Baseline (Week 0) and at Week 12, 24, 36, 48 and at Follow-up visit (Week 60); and at individualized Follow-up visit at Week 72. Due to the termination of this study, analysis of this information was not performed.|Up to Week 72|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564119|NCT02613910|Secondary|Number of Participants With Positive Human Anti-human Antibody (HAHA) Immune Response|Blood samples for HAHA titer analysis were planned to be collected at Baseline (Week 0) and at Week 12, 24, 36, 48 and at Follow-up visit (Week 60); and at individualized Follow-up visit at Week 72. Due to the termination of this study, analysis of this information was not performed.|Up to Week 72|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564120|NCT02613910|Secondary|Cumulative Dose of Corticosteroids|Cumulative dose of corticosteroids was calculated to evaluate steroid exposure and reductions in steroid dose while maintaining disease control. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564121|NCT02613910|Secondary|Number of Days a Participant is Off Steroid Therapy by Week 60|Number of days, a participant did not require steroid therapy was observed and summarized. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564122|NCT02613910|Secondary|Number of Days Minimal Steroid Therapy is Maintained by Week 60|Minimal steroid therapy is an oral prednisone/prednisolone dose of <= 10 mg/day. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564123|NCT02613910|Secondary|Time to Initial Flare/Relapse After Completing the Ofatumumab SC Treatment Course During the Individualized Follow-up Period|It is the time from Baseline to the time of appearance of >=3 new lesions within 1 month that do not heal spontaneously within 1 week, or to the time when there is an extension of lesions that were present at the Baseline visit. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564124|NCT02613910|Secondary|Time to Initial Flare/Relapse After Completing the Ofatumumab SC Treatment Course|It is the time from Baseline to the time of appearance of >=3 new lesions within 1 month that do not heal spontaneously within 1 week, or to the time when there is an extension of lesions that were present at the Baseline visit. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564125|NCT02613910|Secondary|Number of Participants Who do Not Flare/Relapse on Minimal Steroid Therapy|It was planned to assess as participants who achieved remission on minimal steroid therapy and did not subsequently have a flare/relapse of disease by Week 60. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564126|NCT02613910|Secondary|Number of Participants Who do Not Flare/Relapse|It was planned to assess participants with out an appearance of >= 3 new lesions within 1 month that do not heal spontaneously within 1 week, or an extension (worsening) of lesions that were present at the Baseline visit. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564127|NCT02613910|Secondary|Time to Initial Flare/Relapse by Week 60|Time to initial flare/relapse is time from Baseline to the time of appearance of >= 3 new lesions within 1 month that do not heal spontaneously within 1 week, or to the time when there is an extension of lesions that were present at the Baseline visit. The appearance of 1 or 2 new lesions was not to be considered a flare/relapse. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564128|NCT02613910|Secondary|Duration of Remission After Completing the Ofatumumab SC Treatment Course|Duration of remission after completing the ofatumumab SC treatment course was to be assessed during the individualized Follow-up period for participants who were in remission on minimal steroid therapy by Week 60. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564129|NCT02613910|Secondary|Time to Remission on Minimal Steroid Therapy|Time to remission on minimal steroid therapy is the time from Baseline to the time the participant initially tapered his/her oral prednisone/prednisolone dose to <=10 mg/day and maintained <=10 mg/day of oral prednisone/prednisolone with no new or non-healing (established) lesions for >=8 weeks by Week 60. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564130|NCT02613910|Secondary|Number of Participants Achieving Remission on Minimal Steroid Therapy|Remission is defined as absence of new or non-healing (established) lesions for >=8 weeks and minimal steroid therapy is defined as an oral prednisone/prednisolone dose of <=10 mg/day. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564131|NCT02613910|Secondary|Number of Participants Achieving Remission While Off Steroid Therapy by Week 60|Remission is the absence of new or non-healing (established) lesions for >=8 weeks. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564132|NCT02613910|Secondary|Time to Remission Off Steroid Therapy by Week 60|Remission is the absence of new or non-healing (established) lesions for >=8 weeks. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564133|NCT02613910|Secondary|Number of Participants Achieving Sustained Remission on Minimal Steroid Therapy by Week 60|Sustained remission on minimal steroid therapy is the time from Baseline (Week 0) to the time the participant initially tapered his/her oral prednisone/prednisolone dose to <=10 mg/day and maintained <=10 mg/day of oral prednisone/prednisolone with no new or non-healing (established) lesions for >=8 weeks and maintained that status until Week 60. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564134|NCT02613910|Secondary|Duration of Remission on Minimal Steroid Therapy|Duration of remission on minimal steroid therapy is the total time (sum) of all periods of remission while on minimal steroid therapy (oral prednisone/prednisolone dose <=10 mg/day) up to Week 60. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564135|NCT02613910|Secondary|Time to Sustained Remission on Minimal Steroid Therapy|Time to sustained remission on minimal steroid therapy is the time from Baseline (Week 0) to the time the participant initially tapered his/her oral prednisone/prednisolone dose to <=10 mg/day and maintained <=10 mg/day of oral prednisone/prednisolone with no new or non-healing (established) lesions for >= 8 weeks and maintained that status until Week 60. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564136|NCT02613910|Primary|Change From Baseline in Immunoglobulin (Ig) A, IgM, and IgG Levels|Blood samples for IgA, IgM, and IgG analysis were planned to be collected at Baseline (Week 0) and at Week 12, 24, 36, 48 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564137|NCT02613910|Primary|Number of Participants With Laboratory Results of Potential Clinical Concern|Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156 for evaluation of clinical chemistry parameters; and at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156 for evaluation of hematology parameters. No laboratory values of potential clinical concern were identified for this one participant.|Up to Week 156|Safety Population.|||Participants|||Number
2564138|NCT02613910|Primary|Change From Baseline in Specific Gravity of Urine|Urine samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60) for evaluation of urine specific gravity. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline from the individual post-randomization measurements. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564139|NCT02613910|Primary|Change From Baseline in Urine Power of Hydrogen (pH) at the Indicated Time Points|Urine samples were plannedto be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60) for evaluation of pH. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline from the individual post-randomization measurements. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564140|NCT02613910|Primary|Number of Participants With Change in Urinalysis Results|Urine samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60) for evaluation of appearance, protein, glucose, leukocyte esterase, ketones, hemoglobin, microalbumin, creatinine, microalbumin:creatinine ratio and microscopy which included RBC/high powered field, WBC/ hight powered field, epithelial cells, trichomonas, bacteria, yeast, crystals, ammonium urates, mucous threads, amorphous sediment and casts. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline from the individual post-randomization measurements. Due to the termination of this study, analysis of this information was not performed.|Up to Week 60|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564141|NCT02613910|Primary|Change From Baseline in Creatinine Clearance (Calculated) at the Indicated Time Points|Blood samples were plannedto be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564142|NCT02613910|Primary|Change From Baseline in Sodium, Potassium, Chloride, Calcium, Glucose, Bicarbonate and Blood Urea Nitrogen at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564143|NCT02613910|Primary|Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase and Gamma Glutamyl Transferase at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564144|NCT02613910|Primary|Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564145|NCT02613910|Primary|Change From Baseline in Total Protein and Albumin at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 8, 20, 28, 36, 44, 52 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564146|NCT02613910|Primary|Change From Baseline in Red Blood Cell (RBC) Count and Nucleated RBCs at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2566434|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (µmol/L)||Baseline, Week 48|Participants with measurements at given time point.|||µmol/L||Standard Deviation|Mean
2564147|NCT02613910|Primary|Change From Baseline in CD4: CD8 Ratio at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564148|NCT02613910|Primary|Change From Baseline in White Blood Cell (WBC) Count, Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte, Platelet Count, Bands, Cluster of Differentiation (CD)19+ B-lymphocyte Counts, CD3, CD4 and CD8 at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564149|NCT02613910|Primary|Change From Baseline in Hematocrit at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564150|NCT02613910|Primary|Change From Baseline in Hemoglobin at the Indicated Time Points|Blood samples were planned to be collected at Baseline (Week 0) and at Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56 and at Follow-up visit (Week 60); and at individualized Follow-up visits at Week 72, 84, 96, 108, 120, 132, 144 and 156. Baseline was to be considered as the value obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Up to Week 156|Safety Population. Due to the termination of this study, 0 participants were analyzed.||||||
2564151|NCT02613910|Primary|Number of Participants With Clinically-significant Electrocardiogram (ECG) Abnormalities|12-lead ECG was planned to be taken on Baseline (Week 0) and at Follow-up visit (Week 60). No clinically significant ECG abnormalities were noted for the one participant.|Up to Week 60|Safety Population|||Participants|||Number
2564152|NCT02613910|Primary|Number of Participants With Vital Signs of Clinical Concern|Participants with vitals signs of clinical concern were planned to be summarized. No vital signs of clinical concerns were present for the one participant.|Up to Week 60|Safety Population.|||Participants|||Number
2564153|NCT02613910|Primary|Change From Baseline in Body Temperature at the Indicated Time Points|Body temperature was planned to be taken at pre-dose and 4 hour post-dose on Week 4; pre-dose and 1 hour post-dose from Week 6 to Week 56; and at Follow-up visit (Week 60). Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to termination of study, analysis of this information was not performed.|Baseline (Week 0) and up to Week 60|Safety Population.||||||
2564154|NCT02613910|Primary|Change From Baseline in Heart Rate at the Indicated Time Points|Heart rate was to be taken at pre-dose and 4 hour post-dose on Week 4; pre-dose and 1 hour post-dose from Week 6 to Week 56; and at Follow-up visit (Week 60). Measurements were to be obtained in the sitting position and at the time of the blood pressure measurement. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed|Baseline (Week 0) and up to Week 60|Safety Population.||||||
2564155|NCT02613910|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points|SBP and DBP were to be taken at pre-dose and 4 hour post-dose on Week 4; pre-dose and 1 hour post-dose from Week 6 to Week 56; and at Follow-up visit (Week 60). Measurements were to be obtained after at least 5 minutes of rest. Baseline was to be considered as the measurement obtained on Week 0. The change from Baseline was to be calculated by subtracting the Baseline value from the individual post-randomization values. Due to the termination of this study, analysis of this information was not performed.|Baseline (Week 0) and up to Week 60|Safety Population||||||
2564156|NCT02613910|Primary|Number of Participants With Injection Site Reactions|Number of participants with injection site reactions were planned to be summarized. No cases of injection site reaction were reported for the one participant.|Up to Week 60|Safety Population|||Participants|||Number
2564157|NCT02613910|Primary|Number of Participants With Post-injection Systemic Reactions|All serious post-injection systemic reactions were planned to be monitored closely throughout the study and number of participants with post-injection systemic reactions was to be summarized. No cases of post-injection systemic reactions were reported for the one participant.|Up to Week 60|Safety Population|||Participants|||Number
2564158|NCT02613910|Primary|Number of Participants With Infections|All infections were planned to be monitored closely throughout the study and participants with infections were to be summarized. No cases of infection were reported for the one participant.|Up to Week 60|Safety Population|||Participants|||Number
2564159|NCT02613910|Primary|Number of Participants Withdrawn Due to Treatment-related AEs|Participants withdrawn due to treatment related AEs were to be summarized. One participant was enrolled into the study and was withdrawn early due to study termination. The participant was not withdrawn due to treatment-related AEs.|Up to Week 60|Safety Population.|||Participants|||Number
2564198|NCT02613481|Primary|Mean Subject Self Reported Quality of Life Scale|Self report Likert Scale Title: Facial Volume Restoration Outcome Questionnaire 35 Questions 1-7 rating with higher score meaning a worse outcome|3 months post initial injection||||units on a scale||Standard Deviation|Mean
2564160|NCT02613910|Primary|Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESI)|Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention, events associated with liver injury and impaired liver function were to be categorized as SAE. AEs of special interest included any opportunistic infections, serious post injection systemic reactions, progressive multifocal leukoencephalopathy (PML), hepatitis B virus infection or reactivation, severe mucocutaneous reactions (e.g., toxic epidermal necrolysis and stevens-johnson syndrome), cytopenias and cardiovascular events. Participants with SAEs and AESI were to be summarized. No serious adverse events (SAEs) or adverse events of special interest (AESI) reported.|Up to Week 156|Safety Population. One participant was enrolled into the study and was withdrawn early due to study termination. No SAEs or AESIs were reported for this participant.|||Participants|||Number
2564161|NCT02613910|Primary|Number of Participants With Adverse Events Related to Ofatumumab SC|Participants with AEs related to ofatumumab were to be summarized. No adverse events related to ofatumumab were reported for the one participant enrolled.|Up to Week 60|Safety Population. No adverse events related to ofatumumab were reported for the one participant enrolled.|||Participants|||Number
2564162|NCT02613910|Primary|Number of Participants With Severe Adverse Events|Severity is a category utilized for rating the intensity of an adverse event. Participants with severe AEs were to be summarized. No serious adverse events (SAEs) were reported for the one participant enrolled.|Up to Week 60|Safety Population. No safety events were reported for the one participant enrolled.|||Participants|||Number
2564163|NCT02613910|Primary|Number of Participants With Adverse Events(AEs) and AEs Leading to Permanent Discontinuation of Ofatumumab SC (AELD)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs and those with AEs leading to permanent discontinuation of ofatumumab SC (AELD) were to be summarized. Safety Population consists of all participants enrolled in the study. No safety events were reported for the one participant enrolled.|Up to Week 60|Safety Population. No safety events were reported for the one participant enrolled.|||Participants|||Number
2564164|NCT02613897|Secondary|Change in Free Fatty Acids (FFA)|Measure of change in Free Fatty Acids from study start to 16 weeks|Change from baseline to 16 weeks||||mEq/L||Standard Deviation|Mean
2564165|NCT02613897|Secondary|Change in Fasting Plasma Glucagon (FPG)|A measure of the change in fasting plasma glucagon from study start to 16 weeks|Change from baseline to 16 weeks||||mg/dl||Standard Deviation|Mean
2564166|NCT02613897|Secondary|Change in Glucose Oxidation|Change in percentage of glucose oxidation from study start to 16 weeks|Change from baseline to 16 weeks||||percentage of oxidation||Standard Deviation|Mean
2564167|NCT02613897|Secondary|Change in Lipid Oxidation|Change in lipid oxidation percentage from baseline to 16 weeks|Change from baseline to 16 weeks||||percentage of oxidation||Standard Deviation|Mean
2564168|NCT02613897|Secondary|Mean Oral Glucose Tolerance Test (OGTT)|Measure of change in OGTT from study start to 16 weeks|Change from baseline to 16 weeks||||mg/dl||Standard Deviation|Mean
2564169|NCT02613897|Secondary|HBA1c|Change in blood glucose level measured over a 3 month period from study start to 16 weeks|Change from baseline to 16 weeks||||percentage change in blood glucose level||Standard Deviation|Mean
2564170|NCT02613897|Secondary|Change in BMI|Change in BMI (body mass index) from study start to 16 weeks|Change from baseline to 16 weeks||||Kg/m^2||Standard Deviation|Mean
2564171|NCT02613897|Secondary|Change in Body Weight|Change in body weight from baseline to 16 weeks|Baseline to 16 weeks||||Kg||Standard Deviation|Mean
2564172|NCT02613897|Primary|Change in Endogenous Glucose Production (EGP)|All subjects received a Double-Tracer Oral Glucose Tolerance Test (OGTT) with 75g of glucose containing 14C-glucose together with intravenous primed-continuous infusion of 3(3H)-glucose for 240 minutes, at baseline (prior to) and after 16 weeks of therapy. Blood and urine samples were obtained during the OGTT to determine EGP.|Baseline and 16 weeks||||mg/kg*min||Standard Error|Mean
2564173|NCT02613871|Secondary|Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study||First dose date up to Posttreatment Week 108|Participants in Full Analysis Set were analyzed.|||percentage of participants|||Number
2564174|NCT02613871|Secondary|Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108|"FibroScan is a non-invasive device that assesses the hardness (or stiffness) of the liver using the technique of transient elastography. FibroScan results range from 2.5 kPa to 75 kPa with higher scores indicating greater liver stiffness. Per protocol, cirrhosis status was determined as follows:~Presence of cirrhosis = FibroScan result of > 12.5 kPa~Absence of cirrhosis = FibroScan result of ≤ 12.5 kPa"|Posttreatment Weeks 12, 60, and 108|Participants in Full Analysis Set with available data were analyzed.|||kPa||Standard Deviation|Mean
2564175|NCT02613871|Secondary|Percentage of Participants That Required HBV Therapy During the Study||First dose date up to Posttreatment Week 108|Participants in Full Analysis Set were analyzed.|||percentage of participants|||Number
2564176|NCT02613871|Secondary|Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36||Posttreatment Weeks 4, 12, and 36|Participants in Full Analysis Set were analyzed.|||pg/mL||Standard Deviation|Mean
2564177|NCT02613871|Secondary|Serum LOXL-2 Level Change From Baseline While on Treatment||Weeks 1, 2, 4, 8, and 12|Participants in Full Analysis Set with available data were analyzed.|||pg/mL||Standard Deviation|Mean
2564178|NCT02613871|Secondary|HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108||Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108|Participants in Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2564179|NCT02613871|Secondary|HBsAg Level Change From Baseline While on Treatment||Weeks 1, 2, 4, 8, and 12|Participants in Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2564180|NCT02613871|Secondary|Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108||Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108|Participants in Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2564182|NCT02613871|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as :~Breakthrough (confirmed HCV RNA ≥ LLOQ [15 IU/mL] after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment), or~Relapse (HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement)"|First dose date up to Posttreatment Week 12|Participants in Full Analysis Set were analyzed.|||percentage of participants|||Number
2564183|NCT02613871|Secondary|HCV RNA Change From Baseline While on Treatment||Weeks 1, 2, 4, 8, and 12|Participants in Full Analysis Set were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2564184|NCT02613871|Secondary|Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108|LLOQ = 15 IU/mL|Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108|Participants in Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2564185|NCT02613871|Secondary|Percentage of Participants With HCV RNA < LLOQ While on Treatment|LLOQ = 15 IU/mL|Weeks 1, 2, 4, 8, and 12|Participants in Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2564186|NCT02613871|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ (15 IU/mL) at 4 weeks after stopping study treatment.|Posttreatment Week 4|Participants in Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2564187|NCT02613871|Primary|Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug||First dose date up to 12 weeks|Safety Analysis Set included participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2564188|NCT02613871|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantification (LLOQ; 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2564189|NCT02613507|Secondary|Progression Free Survival Rate|Clinical deterioration in the absence of unequivocal evidence of progression (per RECIST 1.1) is not considered progression for purposes of determining PFS. Subjects who die without a reported prior progression will be considered to have progressed on the date of their death. Subjects who did not have disease progression or die will be censored on the date of their last evaluable tumor assessment. Subjects who did not have any on study tumor assessments and did not die will be censored at the randomization date. Subjects who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy. Six month progression-free survival rate as estimated using the Kaplan-Meier method|From the time of randomization to the date of the first documented tumor progression or death due to any cause (assessed from December 2015 to Oct 2017 approximately 22 months)|All randomized participants|||Percentage||95% Confidence Interval|Number
2564190|NCT02613507|Secondary|Median Progression Free Survival (PFS)|PFS was defined as the time from randomization to the date of the first documented tumor progression as determined by investigators per RECIST 1.1, or death due to any cause. Clinical deterioration in the absence of unequivocal evidence of progression (per RECIST 1.1) was not considered progression for purposes of determining PFS. Subjects who died without a reported prior progression were considered to have progressed on the date of their death. Subjects who did not have disease progression or die were censored on the date of their last evaluable tumor assessment. Subjects who did not have any on study tumor assessments and did not die were censored at the randomization date. Subjects who started any subsequent anti-cancer therapy (including on-treatment palliative RT of non-target bone lesions, skin lesions or CNS lesions) without a prior reported progression were censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy|From the time of randomization to the date of the first documented tumor progression or death due to any cause (assessed from December 2015 to Oct 2017 approximately 22 months)|All randomized participants|||Months||95% Confidence Interval|Median
2564191|NCT02613507|Secondary|Overall Survival in Subpopulations|OS was defined as the time between the date of randomization and the date of death. For subjects without documentation of death, OS was censored on the last date the subject was known to be alive. Test stratified by histology (SQ vs NSQ), PD-L1 status at 1%expression level (positive vs negative/unevaluable).|From randomization to the date of death or date participant was last known to be alive (assessed from December 2015 to Oct 2017 approximately 22 months)|All randomized participants|||Months||95% Confidence Interval|Median
2564192|NCT02613507|Secondary|Objective Response Rate|Investigator assessed ORR was defined as the number of subjects whose best objective response (BOR) was a confirmed complete response (CR) or confirmed partial response (PR), as determined by the investigator, divided by the number of randomized subjects|From date of first dose up to assessed from December 2015 to Oct 2017 approximately 22 months|All randomized participants|||Percentage of participants||95% Confidence Interval|Number
2564193|NCT02613507|Primary|Overall Survival Rate|OS was defined as the time between the date of randomization and the date of death. For subjects without documentation of death, OS was censored on the last date the subject was known to be alive. Rates provided are Kaplan-Meier estimates.|From first dose to the date of death or date participant was last known to be alive (assessed from December 2015 to Oct 2017 approximately 22 months)|All randomized participants|||percentage||95% Confidence Interval|Number
2564194|NCT02613507|Primary|Median Overall Survival|OS was defined as the time between the date of randomization and the date of death. For subjects without documentation of death, OS was censored on the last date the subject was known to be alive|From randomization to the date of death or date participant was last known to be alive (assessed from December 2015 to Oct 2017 approximately 22 months)|All randomized participants|||Months||95% Confidence Interval|Median
2564195|NCT02613481|Primary|Mean Subject Self Reported Quality of Life Scale|Self report Likert Scale Title: Facial Volume Restoration Outcome Questionnaire 35 Questions 1-7 rating with higher score meaning a worse outcome|6 months post initial injection||||units on a scale||Standard Deviation|Mean
2564199|NCT02613403|Primary|Number of Participants Who Experienced AST/ALT >5x Upper Limit Normal (ULN)|The number of participants experiencing AST / ALT >5 times ULN from study week 4 until 2 weeks following completion of study therapy was determined.|From Study Week 4 up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)|All randomized participants in Part A receiving ≥1 dose of study treatment with ≥1 AST/ALT measurement subsequent to study week 4. One participant with prior SOF/LDV failure receiving MK-3682B + RBV withdrew from study before study week 4 and was excluded from analysis. Part B terminated prior to enrollment and was not included for analysis.|||Participants|||Count of Participants
2564200|NCT02613403|Primary|Number of Participants Who Experienced a Non-Overdose Event of Clinical Interest|The number of participants experiencing a non-overdose event of clinical interest (ECI) was determined. Non-overdose ECIs, assessed from initiation of study therapy through 14 days following study treatment cessation, included the following: 1) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >500 IU/L; or 2) AST or ALT >3x nadir value and >3X upper limit normal (ULN).|Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)|All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.|||Participants|||Count of Participants
2564201|NCT02613403|Primary|Number of Participants Who Experienced an Accidental or Intentional Overdose Without Adverse Effect|The number of participants experiencing an accidental or intentional overdose without adverse effect was determined. Per study protocol, any occurrence of a participant receiving either MK-3682B or RBV at any dose higher than prescribed was considered an overdose. If this definition of overdose was met without any associated clinical symptoms or abnormal laboratory results, this occurrence of overdose was reported as an accidental or intentional overdose without adverse effect.|Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)|All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.|||Participants|||Count of Participants
2564202|NCT02613403|Primary|Number of Participants Who Experienced a Serious and Drug-Related Adverse Event|The number of participants experiencing a serious and drug-related AE was assessed.|Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)|All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.|||Participants|||Count of Participants
2564203|NCT02613403|Primary|Number of Participants Who Experienced a Drug-Related Adverse Event|The number of participants experiencing a drug-related AE was assessed. A drug-related AE was an AE thought to be possibly, probably, or definitely related to the study drug as determined by the investigator.|Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)|All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.|||Participants|||Count of Participants
2564204|NCT02613403|Primary|Number of Participants Who Experienced a Serious Adverse Event|The number of participants experiencing a serious adverse event (SAE) was assessed. An SAE is an adverse event that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially require medical or surgical intervention.|Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)|All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.|||Participants|||Count of Participants
2564205|NCT02613403|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|The number of participants discontinuing study drug due to an AE was assessed.|Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)|All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.|||Participants|||Count of Participants
2564206|NCT02613403|Primary|Number of Participants Who Experienced an Adverse Event|The number of participants experiencing an adverse event (AE) was assessed. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening of a preexisting condition that is temporally associated with the use of the study treatment is also considered an AE.|Up to 2 weeks following cessation of study treatment ([MK-3682B + RBV Groups]: Up to Week 18; [MK-3682B Groups]: Up to Week 26)|All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.|||Participants|||Count of Participants
2564207|NCT02613403|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)|The percentage of participants achieving SVR12 was determined, defined as having a plasma HCV ribonucleic acid (RNA) level below the lower limit of quantification (LLOQ) 12 weeks after the end of study therapy. Plasma HCV RNA level was measured using the Roche COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay with a LLOQ of 15 IU/mL.|12 weeks following final dose of study treatment ([MK-3682B + RBV Groups]: Study Week 28; [MK-3682B Groups]: Study Week 36)|All randomized participants in Part A receiving ≥1 dose of study treatment. Part B was terminated prior to participant enrollment and was not included for analysis.|||Percentage||95% Confidence Interval|Number
2564208|NCT02613338|Primary|Femoro-tibial Kinematics - Weight-bearing Flexion|Amount of weight-bearing flexion during DKB, gait, and ramp down. All numbers are positive, indicating magnitude.|3 months post-operative||||degrees||Standard Deviation|Mean
2564209|NCT02613338|Primary|Femoro-tibial Kinematics - Axial Rotation|Amount of axial rotation of the femoral component with respect to the tibial component during DKB, gait, and ramp down. Positive indicated external rotation of femur wrt tibia.|3 months post-operative||||degrees||Standard Deviation|Mean
2564403|NCT02610634|Secondary|Gait Parameter: Gait Speed|Measured in meters per second observed when walking recorded via Vicon 3D motion capture. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
2564210|NCT02613338|Secondary|Max Ground Reaction Force - Ramp Down|"Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the activity.~was normalized with respect to participant's body weight and has been termed maximum reaction force."|3 months post-operative||||proportion of body weight||Standard Deviation|Mean
2564211|NCT02613338|Secondary|Max Ground Reaction Force - Gait|"Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the activity.~was normalized with respect to participant's body weight and has been termed maximum reaction force."|3 months post-operative||||proportion of body weight||Standard Deviation|Mean
2564212|NCT02613338|Secondary|Max Ground Reaction Force - Deep Knee Bend|"Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the activity was normalized with respect to participant's body weight and has been termed maximum reaction force."|3 months post-operative||||proportion of body weight||Standard Deviation|Mean
2564213|NCT02613338|Primary|Femoro-tibial Kinematics - Medial Anterior/Posterior Motion|Amount of anterior sliding (positive) and/or posterior rollback (negative) of the medial condyle during DKB, gait, and ramp down|3 months post-operative||||mm||Standard Deviation|Mean
2564214|NCT02613338|Primary|Femoro-tibial Kinematics - Lateral Anterior/Posterior Motion|Amount of anterior sliding (positive) and/or posterior rollback (negative) of the lateral condyle during DKB, gait, and ramp down|3 months post-operative||||mm||Standard Deviation|Mean
2564215|NCT02613221|Secondary|Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs)|Adverse events (AEs) were any unfavorable medical events encountered in a participant treated with a drug. They were not limited to the events with clear causal relationship with treatment with the concerned drug. Treatment-emergent adverse events (TEAEs) were defined as AEs that had occurred after the initiation of protocol treatment.|From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy, assessed up to approximately 29 months|Safety Analysis Set, The safety analysis set was defined as all participants who received at least one dose of the study drug during the study.|||Participants|||Count of Participants
2564216|NCT02613221|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time from the date of enrollment to the date of the decision to discontinue the protocol treatment, the date of documented progression during the protocol treatment, or the date of death from any cause, whichever had come earlier.|From date of enrollment until the date of the protocol treatment discontinuation, progression or death, assessed up to approximately 29 months|Full analysis set (FAS); FAS was defined as participants who were enrolled and received at least one dose of protocol treatment (the recommended dose confirmed in the phase I part).|||Months||95% Confidence Interval|Median
2564217|NCT02613221|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of participants who had shown CR, PR, or SD as the best overall response in accordance with the RECIST version 1.1 criteria.|From date of enrollment until the end of follow-up period, assessed up to approximately 29 months|Full analysis set (FAS); FAS was defined as participants who were enrolled and received at least one dose of protocol treatment (the recommended dose confirmed in the phase I part).|||Percentage of Participants||95% Confidence Interval|Number
2564218|NCT02613221|Secondary|Duration of Response (DOR)|DOR means that the period from the day when either CR or PR is first confirmed until the day of documented PD or the day of death due to all causes, whichever occurs earlier.|From date of CR or PR until the date of PD or death, assessed up to approximately 29 months|Full analysis set (FAS); FAS was defined as participants who were enrolled and received at least one dose of protocol treatment (the recommended dose confirmed in the phase I part).|||Months||95% Confidence Interval|Median
2564219|NCT02613221|Secondary|Response Rate (RR)|RR was defined as the percentage of participants who had shown complete response (CR) or partial response (PR) as the best overall response in accordance with the RECIST 1.1 criteria. The best overall response was CR, followed by PR, stable disease (SD), progressive disease (PD), and not evaluable (NE). CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters as the best overall response after randomization., SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|From date of enrollment until the end of follow-up period, assessed up to approximately 29 months|Full analysis set (FAS); FAS was defined as participants who were enrolled and received at least one dose of protocol treatment (the recommended dose confirmed in the phase I part).|||Percentage of Participants||95% Confidence Interval|Number
2564220|NCT02613221|Secondary|Progression Free Survival (PFS)|PFS was defined as the period from the day of enrollment until the day of documented progression or the day of death due to all causes whichever comes earlier. Progression included both PD based on diagnostic imaging assessed according to response evaluation criteria in solid tumors (RECIST) ver 1.1 and primary disease progression that cannot be confirmed by diagnostic imaging (clinical progression). PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|From date of enrollment until the date of progression or death, assessed up to approximately 29 months|Full analysis set (FAS); FAS was defined as participants who were enrolled and received at least one dose of protocol treatment (the recommended dose confirmed in the phase I part).|||Months||95% Confidence Interval|Median
2564221|NCT02613221|Secondary|Overall Survival (OS)|OS was defined as the period from the day of enrollment until death by all causes.|From date of enrollment until the death, assessed up to approximately 29 months|Full analysis set (FAS); FAS was defined as participants who were enrolled and received at least one dose of protocol treatment (the recommended dose confirmed in the phase I part).|||Months||95% Confidence Interval|Median
2566435|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (µmol/L)||Baseline, Week 24|Participants with measurements at given time point.|||µmol/L||Standard Deviation|Mean
2564222|NCT02613221|Primary|Progression Free Survival (PFS) Rate at 6 Months|PFS rate at 6 months was defined as the crude rate of surviving participants who survived or were not determined as progressive at 6 months from the day of enrollment. Although the subjects who had no imaging data on progression at 6 months after enrollment or the subjects who had lost to follow-up were included in the denominator, these subjects were not handled as progression-free. Progression included both progression disease (PD) based on diagnostic imaging assessed according to response evaluation criteria in solid tumors (RECIST) ver 1.1 and primary disease progression that cannot be confirmed by diagnostic imaging (clinical progression). PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Up to 6 months|Full analysis set (FAS); FAS was defined as participants who were enrolled and received at least one dose of protocol treatment (the recommended dose confirmed in the phase I part).|||Percentage of Participants||90% Confidence Interval|Number
2564223|NCT02613221|Primary|Number of Participants With Dose Limiting Toxicity (DLT) With Panitumumab Plus TAS-102 Combination Therapy|DLT was evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 and was defined as any of the following events: 1. Grade 4 neutropenia for more than 7 days under maximum supportive therapy; 2. Febrile neutropenia; 3. Platelet counts decreased of Grade 3 requiring platelet transfusion or blood platelet decreased of Grade 4; 4. If Course 2 was not initiated within 14 days due to AE related to the protocol treatment; 5. Grade 3 or higher non-hematologic toxicity that was considered clinically significant, except the following cases, Grade 3 gastrointestinal symptoms that could be controlled with supportive therapy (eg, appropriate use of antiemetics, antidiarrheals), and Grade 3 or higher electrolyte abnormalities that were not deemed clinically significant.|Up to approximately 1 month|DLT Evaluation Set; DLT Evaluation Set was defined as participants who were enrolled and received at least one dose of the study drug in order to assess recommended dose of panitumumab in combination with TAS-102 (Total number of DLT Evaluation Set was 6).|||Participants|||Count of Participants
2564224|NCT02613208|Secondary|Mean Biomarker Cancer Antigen 15.3 (CA 15.3) Level|CTC and CA 15.3 levels were compared to determine any correlation between the two. Both CTC count at baseline and at cycle 2 were considered.|Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])|Only included participants that had available data of CA 15.3 levels at baseline|||U/ml||Standard Deviation|Mean
2564225|NCT02613208|Secondary|Mean Carcinoembryonic Antigen (CEA) Levels||Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])|Only included participants that had available data of CEA levels at baseline|||U/ml||Standard Deviation|Mean
2564226|NCT02613208|Secondary|Mean CTC Count Levels|CTC and CEA levels were compared to determine any correlation between the two. Both CTC count at baseline and at cycle 2 were considered.|Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])|Only included participants that had available data of CTC levels at baseline|||count/7.5 ml (CTC)||Standard Deviation|Mean
2564227|NCT02613208|Secondary|PFS as Assessed Using RECIST v1. in Prognostic Groups|An optimal cut-off point for the CTC count of 0.5 after 2 cycles of treatment was used to define the prognostic groups.|From Baseline up to end of study (up to 18 months)|Included only participants that were evaluable for CTC level after cycle 2.|||months||95% Confidence Interval|Median
2564228|NCT02613208|Secondary|Percentage of Participants With Overall Response (OR) as Assessed Using RECIST v1. in Prognostic Groups|Overall response = CR + PR. An optimal cut-off point for the CTC count of 0.5 after 2 cycles of treatment was used to define the prognostic groups.|Baseline (within 21 days prior to Day 1 Cycle 1), 7 days prior to Day 1 Cycle 3 (Cycle length = 28 days)|Included only participants that were evaluable for CTC level after cycle 2.|||Participants|||Count of Participants
2564229|NCT02613208|Secondary|Optimal Cut-off for Clinical Benefit|Clinical benefit was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). Clinical benefit is defined as partial or complete response as well as tumor stabilization for up to 24 weeks. The optimal cut-off for clinical benefit was calculated from a Receiver Operating Curve (ROC) based on CTC level and used to define the prognostic factors that could better predict clinical outcomes.|Baseline (within 21 days prior to Day 1 Cycle 1), 7 days prior to Day 1 Cycle 3 (Cycle length = 28 days)|Included only participants that were evaluable for CTC level after cycle 2.|||cells/7.5 ml|||Number
2564230|NCT02613208|Secondary|Percentage of Participants With Adverse Events of Toxicity Grading 3 and/or 4|Adverse events (AEs) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v 4.0). Any AEs that are not specifically listed in the NCI CTCAE follow the logic - Grade 3) Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4: Life-threatening consequences or urgent intervention indicated.|From Baseline up to end of study (up to 18 months)|Included only participants that were evaluable for CTC level after cycle 2.|||Participants|||Count of Participants
2564231|NCT02613208|Secondary|Overall Survival|OS was evaluated for the Sensitive group (CTC <5) and Resistant group (CTC ≥5).|From Baseline up to end of study (up to 18 months)|Included only participants that were evaluable for CTC level after cycle 2.|||months||95% Confidence Interval|Median
2564232|NCT02613208|Secondary|Progression Free Survival (PFS) as Assessed Using RECIST v1.1|PFS was evaluated for the Sensitive group (CTC <5) and Resistant group (CTC ≥5).|From Baseline up to end of study (up to 18 months)|Included participants that were evaluable for CTC level after cycle 2.|||months||95% Confidence Interval|Median
2564233|NCT02613208|Secondary|Percentage of Participants With Overall Response as Assessed Using RECIST v1.1|Overall response = Complete Response (CR) + Partial Response (PR). Overall response was evaluated for the Sensitive group (CTC <5) and Resistant group (CTC ≥5).|From Baseline up to end of study (up to 18 months)|Included participants that were evaluable for CTC level after cycle 2.|||Participants|||Count of Participants
2564234|NCT02613208|Primary|Percentage of Participants With Clinical Benefit|Clinical benefit was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). Clinical benefit is defined as partial or complete response as well as tumor stabilization for up to 24 weeks. Results for clinical benefit were reported for 2 groups based on Circulating Tumor Cells (CTC) Levels. The Sensitive group had CTC levels <5 (<5 CTCs in one of the two determinations) and Resistant group had CTC ≥5 (≥ 5 CTCs in the two determinations).|During follow-up (up to 18 months)|Included participants that were evaluable for CTC level after cycle 2.|||Participants|||Count of Participants
2564235|NCT02613182|Primary|Long-term Safety and Tolerability of NEOD001|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome, or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|From initiation of study drug through the last study visit or up to 30 days after date of last dose, whichever came first, assessed up to 24 months||||Participants|||Count of Participants
2564236|NCT02612909|Secondary|Phase 3: Geometric Mean Neutralizing Antibody Titer Ratio, With Respect to Day 1|"The MN assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture.~In Phase 3, MN assay was conducted in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in order to have at least 200 evaluable subjects receiving IVACFLU A/H5N1 and 40 evaluable subjects receiving placebo."|Day 43|Subjects who received 2 injections and had valid sera samples for the day measured|||fold change||95% Confidence Interval|Geometric Mean
2564237|NCT02612909|Secondary|Phase 2: Geometric Mean Neutralizing Antibody Titer Ratio, With Respect to Day 1|The microneutralization (MN) assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture.|Day 22, Day 43|Subjects who received the prior injections (as applicable) and had valid sera samples for the day measured|||fold change||95% Confidence Interval|Geometric Mean
2564238|NCT02612909|Secondary|Phase 3: Geometric Mean Neutralizing Antibody Titer|Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.|Day 1, Day 43|Subjects who received 2 injections and had valid sera samples for the day measured|||titer||95% Confidence Interval|Geometric Mean
2564239|NCT02612909|Secondary|Phase 2: Geometric Mean Neutralizing Antibody Titer|The microneutralization (MN) assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture.|Day 1, Day 22, Day 43|Subjects who received the prior injections (as applicable) and had valid sera samples for the day measured|||titer||95% Confidence Interval|Geometric Mean
2564240|NCT02612909|Secondary|Phase 3: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Neutralizing Antibody Titer|"The MN assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture.~In Phase 3, MN assay was conducted in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in order to have at least 200 evaluable subjects receiving IVACFLU A/H5N1 and 40 evaluable subjects receiving placebo."|Day 43|Subjects who received 2 injections and had valid sera samples for the day measured|||Participants|||Count of Participants
2564241|NCT02612909|Secondary|Phase 2: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Neutralizing Antibody Titer|The microneutralization (MN) assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture.|Day 22, Day 43|Subjects who received the prior injections (as applicable) and had valid sera samples for the day measured|||Participants|||Count of Participants
2564242|NCT02612909|Secondary|Number and Percentage of Subjects Experiencing Unsolicited Serious Adverse Events (SAE)|Defined as an adverse event that led to death, was life-threatening (subject at immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in congenital anomaly/birth defect; resulted in a persistent or significant disability or incapacity.|90 days|Subjects who received injections|||Participants|||Count of Participants
2564243|NCT02612909|Secondary|Number and Percentage of Subjects Experiencing Unsolicited Adverse Events (AE)|"Unsolicited AEs were any AEs that occurred any time after study product was given (temporally related to study product), whether or not deemed related to the product, and were not solicited. Unsolicited AEs were either observed by study staff while the subject was at a clinic for a study visit or reported by the subject at any time. Any solicited sign or symptom starting after 7 days post-study product injection was recorded as an unsolicited AE.~For the Phase 2 study, laboratory results were considered AEs when the result was Grade 2 or above.~Any medical condition that was present at the time that the subject was enrolled was not reported as an AE, but was reported as a pre-existing condition on the Medical History Form. However, if this condition occurred with greater frequency or severity during the study, it was recorded as an AE."|21 days after each vaccination|Subjects who received injections|||Participants|||Count of Participants
2564381|NCT02610634|Other Pre-specified|Falls Efficacy Scale - International (FES-I)|Fear of falling will be measured using the falls efficacy scale - international version. This is a short and valid measure of fear of falling in older adults, which assesses basic and demanding activities (both physical and social). It consists of 16 scenarios (e.g. cleaning the house) and subjects must rate their fear of falling on a scale from 1 (Not at all concerned) to 4 (Very concerned).|Session 1 (full session lasts approx. 3 hours)|||||||
2564244|NCT02612909|Secondary|Number and Percentage of Subjects Experiencing Reactogenicity|"Reported solicited signs and symptoms were recorded by the subject on the Diary Card from Days 1-7 and Days 22-28 in the study, then evaluated by study physician on Days 8, 22, and 29.The evaluated solicited local reactogenicity events were as follows:~Size of redness (at site of injection) in centimeters (cm)~Size of swelling (at site of injection) in cm~Size of induration (hardness at site of injection) in cm~Pain (at site of injection)~Tenderness (at site of injection)~The evaluated solicited systemic reactogenicity events were as follows:~Fever/body temperature (and body location of measurement)~Fatigue/malaise~Generalized muscle aches~Joint aches/pains~Chills~Nausea~Vomiting~Headache"|7 days after each vaccination|Subjects who received injections|||Participants|||Count of Participants
2564245|NCT02612909|Secondary|Number and Percentage of Subjects Experiencing Reactogenicity|"Immediate reactogenicity (30 minutes post-injection) were evaluated on Day 1 and Day 22 and consisted of:~Inspection of the upper arms for the presence or absence of redness, swelling, hardness, pain, or tenderness; and~Documentation of the presence or absence of headache, fever, fatigue/malaise, muscle aches, joint aches, nausea, vomiting, or chills.~Immediate reactogenicity were assessed by a study physician or appropriately trained medical staff."|30 minutes after each injection|Subjects who received injections|||Participants|||Count of Participants
2564246|NCT02612909|Secondary|Phase 3: Geometric Mean Hemagglutination Inhibition (HAI) Titer Ratio, With Respect to Day 1|Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.|Day 43|Subjects who received 2 injections and had valid sera samples for the day measured|||fold change||95% Confidence Interval|Geometric Mean
2564247|NCT02612909|Secondary|Phase 2: Geometric Mean Hemagglutination Inhibition (HAI) Titer Ratio, With Respect to Day 1|Serum specimens were tested for the presence of HAI antibodies to influenza on day 1, day 22, and day 43 (day 1 and 22 prior to injection). The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.|Day 22, Day 43|Subjects who received the prior injections (as applicable) and had valid sera samples for the day measured|||fold change||95% Confidence Interval|Geometric Mean
2564248|NCT02612909|Secondary|Phase 3: Geometric Mean Hemagglutination Inhibition (HAI) Titer|Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.|Day 1, Day 43|Subjects who received 2 injections and had valid sera samples for the day measured|||titer||95% Confidence Interval|Geometric Mean
2564249|NCT02612909|Secondary|Phase 2: Geometric Mean Hemagglutination Inhibition (HAI) Titer|Serum specimens were tested for the presence of HAI antibodies to influenza on day 1, day 22, and day 43 (day 1 and 22 prior to injection). The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.|Day 1, Day 22, Day 43|Subjects who received the prior injections (as applicable) and had valid sera samples for the day measured|||titer||95% Confidence Interval|Geometric Mean
2564250|NCT02612909|Secondary|Phase 3: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Hemagglutination Inhibition (HAI) Titer|Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.|Day 43|Subjects who received 2 injections and had valid sera samples for the day measured|||Participants|||Count of Participants
2564251|NCT02612909|Secondary|Phase 2: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Hemagglutination Inhibition (HAI) Titer|Serum specimens were tested for the presence of HAI antibodies to influenza on day 1, day 22, and day 43 (day 1 and 22 prior to injection). The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.|Day 22, Day 43|Subjects who received the prior injections (as applicable) and had valid sera samples for the day measured|||Participants|||Count of Participants
2564252|NCT02612909|Secondary|Phase 2: Number and Percentage of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer of ≥1:40|Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.|Day 1, Day 22|Subjects who received 2 injections and had valid sera samples for the day measured|||Participants|||Count of Participants
2564253|NCT02612909|Primary|Number and Percentage of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer of ≥1:40|Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study.|Day 1, Day 43|Subjects who received 2 injections and had valid sera samples for the day measured|||Participants|||Count of Participants
2564254|NCT02612857|Secondary|Change From Baseline in CDASI (Cutaneous Disease and Activity Severity Index) Activity Score|Change from baseline in mCDASI (Cutaneous Disease and Activity Severity Index) v2-Activity score as measured at Visits 2, 6, 10, 14, 18, 22 and 26 (EOT/ Week 25). Index is Clinician administered one page instrument designed to evaluate the cutaneous manifestations of DM. CDASI yields a total score that captures overall disease state, an activity score (range:0-100) that reflects the current inflammatory state of disease and a damage score (range: 0-32). The CDASI includes separate measurements for disease activity and damage and yields a total score that captures overall disease state, an activity score that reflects the current inflammatory state of disease, and a damage score. Decreases in CDASI scores are indicative of improvement. In this study, Activity Scores were measured. The scores below are averaged.|28 weeks (24 weeks treatment + 4 weeks follow up)|Some patients did not complete all visits|||units on a scale||95% Confidence Interval|Least Squares Mean
2564255|NCT02612857|Primary|To Assess the Safety and Tolerability of IMO-8400 in Adult Subjects With DM|Number of participants with different types of Treatment Emergent Adverse Events|28 weeks (24 weeks treatment + 4 weeks follow up)||||participants|||Number
2564256|NCT02612727|Primary|Safety of Phototherapy|For a given treatment day, the phototherapy treatment was deemed safe if that infant on that day did not have to be withdrawn from treatment due to hypo- or hyperthermia, sunburn or dehydration. Therefore safety is reported as a percentage of the total treatment days (i.e. number of safe treatment days divided by total number of treatment days).|2 to 10 days||||treatment days|treatment days||Count of Units
2564257|NCT02612727|Primary|Efficacy of Phototherapy|For a given evaluable treatment day, the phototherapy treatment was deemed effective if that infant on that day had a decrease in serum bilirubin level or (if <72hrs old) an rate of increase of less than 0.2 mg/dL/h. Therefore efficacy is reported as a percentage of the evaluable treatment days (i.e. number of effective evaluable treatment days divided by total number of evaluable treatment days).|2 to 10 days|The efficacy analysis used all treatment days where an infant received >=4h of PT and both bilirubin levels were available. 87 infants received 215 treatment days of FSPT, but only 133 of those days (in 79 infants) were analyzable for efficacy. Similarly, 87 infants received 219 days of IntPT, but only 152 days (in 83 infants) were analyzable.|||treatment days|treatment days||Count of Units
2564258|NCT02612623|Primary|Change From Baseline in Awake Cough Frequency After 8 Weeks of Treatment.|Cough monitoring was conducted for 24 hours while awake, at pre-dose on Day 0, and after administration of the study drug on Day 56. The cough frequency is the coughs/hr over each 24 hour period. An independent cough monitoring core lab provided documentation of the time of each cough event over each 24-hour period. A negative change indicates a decrease in cough frequency, while a positive change indicates an increase in cough frequency.|Baseline and Week 8 (Day 56)|All randomized participants who took at least 1 dose of study medication and provided at least one baseline and at least one post-dose observation.|||Coughs/hour||Standard Deviation|Mean
2564259|NCT02612610|Secondary|Taste Questionnaire: Percentage of Participants That Found Taste Effect of Study Medication Bothersome After 12 Weeks of Treatment (Day 84)|"The tolerance to taste-related adverse events (AEs) was evaluated at the end of the study (Day 84) and a structured taste questionnaire was administered to participants experiencing a taste-related AE to determine what degree the participant found the taste effect bothersome by answering the question How bothersome is the taste effect of the medication? The counts and percentages of categorical responses to the individual items were computed for each treatment group."|Day 84|All randomized participants who had taken at least 1 dose of study medication, who had experienced a taste-related AE, and who had Day 84 taste questionnaire data available.|||percentage of participants|||Number
2564260|NCT02612610|Secondary|Taste Questionnaire: Percentage of Participants That Experienced Taste Effect After Taking Medication by Frequency After 12 Weeks of Treatment (Day 84)|"The tolerance to taste-related adverse events (AEs) was evaluated at the end of the study (Day 84) and a structured taste questionnaire was administered to participants experiencing a taste-related AE. Participants were asked to indicate the frequency that they experienced the taste effect by answering the question How frequently do you experience the taste effect after taking each dose of medication? The counts and percentages of categorical frequency responses to the individual items were computed for each treatment group."|Day 84|All randomized participants who had taken at least 1 dose of study medication, who had experienced a taste-related AE, and who had Day 84 taste questionnaire data available.|||percentage of participants|||Number
2564261|NCT02612610|Secondary|Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication Twice Daily|"At the end of the treatment period (Day 85), participants were asked How likely would you be to take this medication? This question was asked in reference to the time frame of Twice daily. The counts and percentages of ordered categorical responses to this question were computed for each treatment group."|Day 85/Early Termination|All randomized participants who had taken at least 1 dose of study medication and had available Acceptability Questionnaire data for the twice daily question at Day 85.|||percentage of participants|||Number
2564262|NCT02612610|Secondary|Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Four Weeks|"At the end of the treatment period (Day 85), participants were asked How likely would you be to take this medication? This question was asked in reference to the time frame of At least four weeks. The counts and percentages of ordered categorical responses to this question were computed for each treatment group."|Day 85/Early Termination|All randomized participants who had taken at least 1 dose of study medication and had available Acceptability Questionnaire data for the four week question at Day 85.|||percentage of participants|||Number
2564263|NCT02612610|Secondary|Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least Six Months|"At the end of the treatment period (Day 85), participants were asked How likely would you be to take this medication? This question was asked in reference to the time frame of At least six months. The counts and percentages of ordered categorical responses to this question were computed for each treatment group."|Day 85/Early Termination|All randomized participants who had taken at least 1 dose of study medication and had available Acceptability Questionnaire data for the six month question at Day 85.|||percentage of participants|||Number
2564382|NCT02610634|Other Pre-specified|Freezing of Gait (FOG) Questionnaire|This is a 10 item questionnaire intended to classify freezing of gait. The questionnaire has 3 parts; distinction of freezers from non-freezers, Freezing severity, frequency and duration and impact of freezing on daily life.|Session 1 (full session lasts approx. 3 hours)|||||||
2564264|NCT02612610|Secondary|Acceptability Questionnaire: Percentage of Participants That Were Likely to Take Study Medication For At Least One Year|"At the end of the treatment period (Day 85), participants were asked How likely would you be to take this medication? This question was asked in reference to the time frame of At least one year. The counts and percentages of ordered categorical responses to this question were computed for each treatment group."|Day 85/Early Termination|All randomized participants who had taken at least 1 dose of study medication and had available Acceptability Questionnaire data for the one year question at Day 85.|||percentage of participants|||Number
2564265|NCT02612610|Secondary|"Percentage of Participants Rated as Very Much Improved or Much Improved by Clinicians According to the Clinician's Global Impression of Change (CGIC) at Day 85/Early Termination"|"The Clinician's Global Impression of Change (CGIC) reflects a clinician's belief about the efficacy of treatment. CGIC is a 7-point scale depicting a clinician's rating of a participant's overall improvement. Clinicians rated the participant's change at Week 12 (Day 85) as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The counts and percentages of ordered responses to the clinician's global perception of change were computed for each treatment group, and the percentage of participants rated by clinicians as having improvement (either very much improved or much improved on the CGIC scale) was reported for each treatment group."|Day 85/Early Termination|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and 1 Day 85 CGIC observation during the treatment period.|||percentage of participants|||Number
2564266|NCT02612610|Secondary|"Percentage of Participants Reporting Very Much Improved or Much Improved According to the PGIC at Day 85/Early Termination"|"The self-reported measure Patient's Global Impression of Change (PGIC) reflects a participant's belief about the efficacy of treatment. PGIC is a 7-point scale depicting a patient's rating of overall improvement. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The counts and percentages of ordered responses to the participant's global perception of change were computed for each treatment group on Day 28 and the percentage of participants with improvements (either very much improved or much improved on the PGIC scale) was reported for each treatment group."|Day 85/Early Termination|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and 1 Day 85 PGIC observation during the treatment period.|||percentage of participants|||Number
2564267|NCT02612610|Secondary|"Percentage of Participants Reporting Very Much Improved or Much Improved According to the PGIC After 8 Weeks of Treatment (Day 56)"|"The self-reported measure Patient's Global Impression of Change (PGIC) reflects a participant's belief about the efficacy of treatment. PGIC is a 7-point scale depicting a patient's rating of overall improvement. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The counts and percentages of ordered responses to the participant's global perception of change were computed for each treatment group on Day 28 and the percentage of participants with improvements (either very much improved or much improved on the PGIC scale) was reported for each treatment group."|Day 56|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and 1 Day 56 PGIC observation during the treatment period.|||percentage of participants|||Number
2564268|NCT02612610|Secondary|"Percentage of Participants Reporting Very Much Improved or Much Improved According to the Patient's Global Impression of Change (PGIC) After 4 Weeks of Treatment (Day 28)"|"The self-reported measure Patient's Global Impression of Change (PGIC) reflects a participant's belief about the efficacy of treatment. PGIC is a 7-point scale depicting a patient's rating of overall improvement. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The counts and percentages of ordered responses to the participant's global perception of change were computed for each treatment group on Day 28 and the percentage of participants with improvements (either very much improved or much improved on the PGIC scale) was reported for each treatment group."|Day 28|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and 1 Day 28 PGIC observation during the treatment period.|||percentage of participants|||Number
2564269|NCT02612610|Secondary|Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score At Day 85/Early Termination|The LCQ instrument is designed to assess the impact of cough on various aspects of a participant's life over the preceding 2 weeks. It consists of 19 items which are divided over 3 domains: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, 19). A 7-point Likert scale is used to rate each item. For each domain, the domain score (range 1-7) is the sum of the individual item scores within the domain divided by the number of items in the domain. The total score is the sum of the three domain scores and ranges from 3-21; a higher score corresponds to a better health status. Baseline LCQ was defined as the LCQ collected at Baseline (Study Day -1). LS mean change from baseline in total LCQ score was reported for each treatment group with associated SE.|Baseline, Day 85/Early Termination|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564270|NCT02612610|Secondary|Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score After 8 Weeks of Treatment (Day 56)|The LCQ instrument is designed to assess the impact of cough on various aspects of a participant's life over the preceding 2 weeks. It consists of 19 items which are divided over 3 domains: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, 19). A 7-point Likert scale is used to rate each item. For each domain, the domain score (range 1-7) is the sum of the individual item scores within the domain divided by the number of items in the domain. The total score is the sum of the three domain scores and ranges from 3-21; a higher score corresponds to a better health status. Baseline LCQ was defined as the LCQ collected at Baseline (Study Day -1). LS mean change from baseline in total LCQ score was reported for each treatment group with associated SE.|Baseline, Day 56|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2566436|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Aspartate Aminotransferase (U/L)||Baseline, Week 48|Participants with measurements at given time point.|||U/L||Standard Deviation|Mean
2564271|NCT02612610|Secondary|Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score After 4 Weeks of Treatment (Day 28)|The LCQ instrument is designed to assess the impact of cough on various aspects of a participant's life over the preceding 2 weeks. It consists of 19 items which are divided over 3 domains: Physical (items 1, 2, 3, 9, 10, 11, 14 and 15), Psychological (4, 5, 6, 12, 13, 16, and 17), and Social (7, 8, 18, 19). A 7-point Likert scale is used to rate each item. For each domain, the domain score (range 1-7) is the sum of the individual item scores within the domain divided by the number of items in the domain. The total score is the sum of the three domain scores and ranges from 3-21; a higher score corresponds to a better health status. Baseline LCQ was defined as the LCQ collected at Baseline (Study Day -1). LS mean change from baseline in total LCQ score was reported for each treatment group with associated SE.|Baseline, Day 28|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564272|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 12|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 12|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564273|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 11|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 11|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564274|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 10|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 10|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564275|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 9|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 9|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564276|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 8|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 8|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564277|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 7|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 7|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564278|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 6|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 6|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564279|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 5|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 5|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564280|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 4|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 4|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564281|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 3|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 3|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564282|NCT02612610|Secondary|Change From Baseline in Weekly Mean DCS at Week 2|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 2|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564283|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily Cough Score (DCS) at Week 1|The DCS has a score ranging from 0 (best) to 10 (worst). Weekly mean daily score was defined as the average of the daily scores for each week. Baseline was defined as the average DCS score collected during the week prior to Day 1 (Day -7 to Day -1). Participants rated the severity of their cough using the DCS each day. LS mean change from baseline of the weekly mean Daily Cough Score with associated SE was reported for each treatment group.|Baseline, Week 1|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564284|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 12|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 12|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564285|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 11|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 11|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564286|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 10|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 10|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564287|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 9|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 9|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564335|NCT02611752|Secondary|Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)|"Analysis Results for Bipolar Alertness/Drowsiness Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item At this moment, my mental state is where values can range from 0 (Very Drowsy) to 100 (Very alert), with 50 being neutral (Neither drowsy nor alert)."|15 days|(Completer Population)|||units on a scale||Standard Error|Least Squares Mean
2564288|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 8|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 8|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564289|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 7|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 7|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564290|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 6|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 6|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564291|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 5|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 5|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564292|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 4|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 4|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564293|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 3|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 3|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564294|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily CSD Total Score at Week 2|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 2|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564295|NCT02612610|Secondary|Change From Baseline in Weekly Mean Daily Cough Severity Diary (CSD) Total Score at Week 1|The daily CSD instrument has a total of 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD is the sum of these 7 item scores (Min=0, Max=70). Mean total daily score (the sum of 7 item scores divided by 7) was derived for each day. Weekly mean total daily score was defined as the average of the mean total daily scores for each week. LS mean change from baseline of the weekly mean total daily CSD score was reported for each treatment group with associated SE. Baseline was defined as the average CSD scores collected during the week prior to Day 1 (Study Day -7 to Day -1).|Baseline, Week 1|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||score on a scale||Standard Error|Least Squares Mean
2564296|NCT02612610|Secondary|Change From Baseline in Sleep Objective Cough Frequency After 12 Weeks of Treatment (Day 84)|Sleep Objective Cough Frequency was defined as the total number of cough events during the monitoring period while the participant was asleep divided by the total duration in hours for the monitoring period that the participant was asleep. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Sleep Objective Cough Frequency = (Post-Treatment Objective Sleep Cough Frequency minus Baseline Sleep Cough Frequency).|Baseline (Study Day -1), Day 84|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||log coughs/hour||Standard Error|Least Squares Mean
2564297|NCT02612610|Secondary|Change From Baseline in Sleep Objective Cough Frequency After 8 Weeks of Treatment (Day 56)|Sleep Objective Cough Frequency was defined as the total number of cough events during the monitoring period while the participant was asleep divided by the total duration in hours for the monitoring period that the participant was asleep. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Sleep Objective Cough Frequency = (Post-Treatment Objective Sleep Cough Frequency minus Baseline Sleep Cough Frequency).|Baseline (Study Day -1), Day 56|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||log coughs/hour||Standard Error|Least Squares Mean
2564298|NCT02612610|Secondary|Change From Baseline in Sleep Objective Cough Frequency After 4 Weeks of Treatment (Day 28)|Sleep Objective Cough Frequency was defined as the total number of cough events during the monitoring period while the participant was asleep divided by the total duration in hours for the monitoring period that the participant was asleep. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Sleep Objective Cough Frequency = (Post-Treatment Objective Sleep Cough Frequency minus Baseline Sleep Cough Frequency).|Baseline (Study Day -1), Day 28|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||log coughs/hour||Standard Error|Least Squares Mean
2564299|NCT02612610|Secondary|Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency at the Follow-up Visit (Day 98)|24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 14 (Day 98) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in 24-hr Objective Cough Frequency were reported for each treatment group at Day 98.|Baseline (Study Day -1), Day 98|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 98 endpoint observation during the treatment period.|||percentage of participants|||Number
2564300|NCT02612610|Secondary|Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84)|24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in 24-hr Objective Cough Frequency were reported for each treatment group at Day 84.|Baseline (Study Day -1), Day 84|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 84 endpoint observation during the treatment period.|||percentage of participants|||Number
2564301|NCT02612610|Secondary|Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56)|24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in 24-hr Objective Cough Frequency were reported for each treatment group at Day 56.|Baseline (Study Day -1), Day 56|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 56 endpoint observation during the treatment period.|||percentage of participants|||Number
2564336|NCT02611752|Secondary|Analysis Results for Unipolar Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)|"Analysis Results for Desire to Use Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) comparing hydromorphone challenge doses in each of the baseline and four challenge sequence with each other, presented as Least Squares (LS) Mean with Standard Error (SE) and 95% Confidence Interval (CI). VAS item At this moment, I desire opiods where values can range from 0 (Definitely not) to 100 (Definitely so)."|15 days|(Completer Population)|||units on a scale||Standard Error|Least Squares Mean
2564302|NCT02612610|Secondary|Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28)|24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in 24-hr Objective Cough Frequency were reported for each treatment group at Day 28.|Baseline (Study Day -1), Day 28|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 28 endpoint observation during the treatment period.|||percentage of participants|||Number
2564303|NCT02612610|Secondary|Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98)|Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at the Follow-up visit (Day 98) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in Awake Objective Cough Frequency were reported for each treatment group at Day 98.|Baseline (Study Day -1), Day 98|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 98 endpoint observation during the treatment period.|||percentage of participants|||Number
2564304|NCT02612610|Secondary|Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84)|Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in Awake Objective Cough Frequency were reported for each treatment group at Day 84.|Baseline (Study Day -1), Day 84|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 84 endpoint observation during the treatment period.|||percentage of participants|||Number
2564305|NCT02612610|Secondary|Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56)|Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in Awake Objective Cough Frequency were reported for each treatment group at Day 56.|Baseline (Study Day -1), Day 56|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 56 endpoint observation during the treatment period.|||percentage of participants|||Number
2564306|NCT02612610|Secondary|Percentage of Participants With ≥70%, ≥50%, and ≥30% Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28)|Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. The percentage of participants that met responder criteria for ≥70%, ≥50%, and ≥30% change (reduction) from baseline levels in Awake Objective Cough Frequency were reported for each treatment group at Day 28.|Baseline (Study Day -1), Day 28|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one Day 28 endpoint observation during the treatment period.|||percentage of participants|||Number
2564307|NCT02612610|Secondary|Change From Baseline in Cough Severity VAS At Day 85/Early Termination|Cough VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline (Study Day -1) and at Day 85/Early Termination. Baseline cough VAS was defined as the cough VAS at Baseline (Study Day -1). LS mean change from baseline with associated SE reported for each treatment group.|Baseline (Study Day -1), Day 85|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||units on a scale||Standard Error|Least Squares Mean
2564308|NCT02612610|Secondary|Change From Baseline in Cough Severity VAS After 12 Weeks of Treatment (Day 84)|Cough VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline (Study Day -1) and at Week 12 (Day 84). Baseline cough VAS was defined as the cough VAS at Baseline (Study Day -1). LS mean change from baseline with associated SE reported for each treatment group.|Baseline (Study Day -1), Day 84|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||units on a scale||Standard Error|Least Squares Mean
2564309|NCT02612610|Secondary|Change From Baseline in Cough Severity VAS After 8 Weeks of Treatment (Day 56)|Cough VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline (Study Day -1) and at Week 8 (Day 56). Baseline cough VAS was defined as the cough VAS at Baseline (Study Day -1). LS mean change from baseline with associated SE reported for each treatment group.|Baseline (Study Day -1), Day 56|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||units on a scale||Standard Error|Least Squares Mean
2564310|NCT02612610|Secondary|Change From Baseline in Cough Severity Visual Analogue Scale (VAS) After 4 Weeks of Treatment (Day 28)|Cough VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline (Study Day -1) and at Week 4 (Day 28). Baseline cough VAS was defined as the cough VAS at Baseline (Study Day -1). LS mean change from baseline with associated SE reported for each treatment group.|Baseline (Study Day -1), Day 28|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||units on a scale||Standard Error|Least Squares Mean
2564311|NCT02612610|Secondary|Change From Baseline in Awake Objective Cough Frequency at the Follow-up Visit (Day 98)|Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at the Follow-up visit (Day 98) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. Change from Baseline in Awake Objective Cough Frequency = (Post-Treatment Awake Cough Frequency minus Baseline Awake Cough Frequency).|Baseline (Study Day -1), Day 98|All randomized participants who had taken at least 1 dose of study medication and provided baseline and follow-up visit (Day 98) data during the treatment period.|||coughs/hour||Standard Deviation|Mean
2564312|NCT02612610|Secondary|Change From Baseline in Awake Objective Cough Frequency After 8 Weeks of Treatment (Day 56)|Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Awake Objective Cough Frequency = (Post-Treatment Awake Cough Frequency minus Baseline Awake Cough Frequency).|Baseline (Study Day -1), Day 56|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||log coughs/hour||Standard Error|Least Squares Mean
2564313|NCT02612610|Secondary|Change From Baseline in Awake Objective Cough Frequency After 4 Weeks of Treatment (Day 28)|Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in Awake Objective Cough Frequency = (Post-Treatment Awake Cough Frequency minus Baseline Awake Cough Frequency).|Baseline (Study Day -1), Day 28,|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||log coughs/hour||Standard Error|Least Squares Mean
2564314|NCT02612610|Secondary|Change From Baseline in 24-Hour Objective Cough Frequency After 12 Weeks of Treatment (Day 84)|24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in 24-Hour Objective Cough Frequency = (Post-Treatment 24-Hour Cough Frequency minus Baseline 24-Hour Cough Frequency).|Baseline (Study Day -1), Day 84|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||log coughs/hour||Standard Error|Least Squares Mean
2564315|NCT02612610|Secondary|Change From Baseline in 24-Hour Objective Cough Frequency After 8 Weeks of Treatment (Day 56)|24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 8 (Day 56) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in 24-Hour Objective Cough Frequency = (Post-Treatment 24-Hour Cough Frequency minus Baseline 24-Hour Cough Frequency).|Baseline (Study Day -1), Day 56|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||log coughs/hour||Standard Error|Least Squares Mean
2564383|NCT02610634|Other Pre-specified|Hoehn & Yahr (H & Y) Scale|The Hoehn and Yahr rating scale is a widely used clinical rating scale, which defines broad categories of motor function in Parkinson's disease (PD). All participants' will be tested who are in H &Y stages I-III.|Session 1 (full session lasts approx. 3 hours)|||||||
2564316|NCT02612610|Secondary|Change From Baseline in 24-Hour Objective Cough Frequency After 4 Weeks of Treatment (Day 28)|24-hr Objective Cough Frequency was defined as the total number of cough events during the monitoring period divided by the total duration in hours for the monitoring period (generally 24 hours). 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 4 (Day 28) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. LS mean change from baseline (in log scale) with associated SE reported for each treatment group. Change from Baseline in 24-Hour Objective Cough Frequency = (Post-Treatment 24-Hour Cough Frequency minus Baseline 24-Hour Cough Frequency).|Baseline (Study Day -1), Day 28|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline endpoint observation during the treatment period.|||log coughs/hour||Standard Error|Least Squares Mean
2564317|NCT02612610|Primary|Change From Baseline in Awake Objective Cough Frequency After 12 Weeks of Treatment (Day 84)|Awake Objective Cough Frequency (per hour) was defined as the total number of cough events during the monitoring period (in general, 24-hr interval) while the participant was awake divided by the total duration (in hours) for the monitoring period that the participant was awake. 24 hour sound recordings were made at Baseline (Study Day -1) and at Week 12 (Day 84) using a digital recording device. An independent cough monitoring center documented the time of each cough event over the 24 hour period, as well as the time when the participant went to sleep and the time the participant woke. Least-squares (LS) mean change from baseline (in log scale) with associated standard error (SE) reported for each treatment group. Change from Baseline in Awake Objective Cough Frequency = (Post-Treatment Awake Cough Frequency minus Baseline Awake Cough Frequency).|Baseline Visit (Day -1), Day 84|All randomized participants who had taken at least 1 dose of study medication and provided at least 1 baseline and at least one post baseline primary endpoint observation during the treatment period.|||log coughs/hour||Standard Error|Least Squares Mean
2564318|NCT02612428|Secondary|Number of Subjects With Early Change in Bilirubin Levels at Study Day 7|To estimate the effect of ELAD on the number of subjects achieving a 20% reduction in total bilirubin by Day 7 (ECBL20 Yes)|Up to Study Day 7||||Participants|||Count of Participants
2564319|NCT02612428|Secondary|Number of Survivors at Study Day 91|Assess the proportion of survivors at Study Day 91|Up to Study Day 91||||Participants|||Count of Participants
2564320|NCT02612428|Primary|Overall Survival|The primary endpoint of the study was a comparison of overall survival (OS) between the ELAD-treated and Control groups, with protocol VTL-308E providing additional survival data up to a maximum of 5 years, that was included as available at the time of database lock (28 Aug 2018).|Up to at least Study Day 91, with protocol VTL-308E providing additional survival data (at 6, 9, 12, 24 months) at the time of database lock (28 August 2018).||||Participants|||Count of Participants
2564321|NCT02612285|Primary|Clinical Response Rate|Effect of SNX-5422 on tumor progression. Complete remissions plus partial remissions plus stable disease at ≥6 months) will be listed by subject. Tumor measurements made using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or appropriate hematological malignancy criteria.|6 months|Subject withdrew from study before any data points gathered||||||
2564322|NCT02612077|Secondary|Quality of Life - Global Health Status|Participants rated their quality of life (global health status) on the European Organization for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire (EORTC QLQ C-30), with total scores ranging from 0 (worst) to 100 (best).|Baseline, 6 and 12 months|Participants in the efficacy analysis set who filled out the questionnaire at inclusion|||units on a scale||Inter-Quartile Range|Median
2564323|NCT02612077|Secondary|Overall Survival|Overall Survival (OS) was defined as the time between the treatment start (date of the first infusion of bevacizumab) and death from any cause. Kaplan Meier estimates of median overall survival were calculated for the metastatic lines of treatment, with a median follow-up of 18, 15 and 13 months, respectively.|Up to 36 months|Efficacy analysis set receiving bevacizumab at inclusion|||Months||95% Confidence Interval|Median
2564324|NCT02612077|Primary|Progression-free Survival|Kaplan Meier estimates of median progression-free survival according to the metastatic line of treatment, for a median follow-up of 18, 15 and 13 months, respectively|within 36 months|Efficacy analysis set receiving bevacizumab at inclusion|||Months||95% Confidence Interval|Median
2564325|NCT02612064|Secondary|Change From Baseline in Tactile Threshold Post First Treatment by Direct Application and on Day 3|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline, 60 seconds post first treatment, Day 3|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||g||Standard Deviation|Mean
2564326|NCT02612064|Secondary|Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline to 60 seconds post first treatment|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||score on a scale||Standard Deviation|Mean
2564384|NCT02610634|Other Pre-specified|The Unified Parkinson's Disease Rating Scale (UPDRS)|The Unified Parkinson's Disease Rating Scale will be used to assess motor and non-motor features of PD and disease severity. The UPDRS is scored from a total of 195 points; higher scores reflect worsening disability.|Session 1 (full session lasts approx. 3 hours)|||||||
2564327|NCT02612064|Primary|Change From Baseline in Schiff Sensitivity Score on Day 3|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.|Baseline to 3 days|Analysis for this outcome was performed on ITT population, defined as all participants who were randomized, received the study treatment at least once and provided at least one post-baseline (post treatment) assessment.|||Score on a scale||Standard Deviation|Mean
2564328|NCT02611830|Secondary|Percentage of Participants Achieving Corticosteroid-free Remission at Week 52|Corticosteroid-free remission is defined as participants using oral corticosteroids at Baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52. Clinical remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).|Week 52|Participants from FAS, who used concomitant oral corticosteroid at Baseline. FAS included all randomized participants who received at least 1 dose of study drug and who only received induction IV therapy and were not randomized into maintenance phase were not included in FAS; participants were analyzed according to randomized treatment assignment.|||percentage of participants||95% Confidence Interval|Number
2564329|NCT02611830|Secondary|Percentage of Participants Achieving Durable Clinical Remission at Week 6 and Week 52|Durable clinical remission is defined as clinical remission at both Weeks 6 and 52. Clinical remission is defined as a complete Mayo score of less than or equal to (≤) 2 points and no individual subscore greater than (>) 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).|Weeks 6 and 52|The FAS included all randomized participants who received at least 1 dose of study drug. Participants who only received induction IV therapy and were not randomized into the maintenance phase were not included in the FAS; participants were analyzed according to the randomized treatment assignment.|||percentage of participants||95% Confidence Interval|Number
2564330|NCT02611830|Secondary|Percentage of Participants Achieving Durable Clinical Response at Week 6 and Week 52|Durable clinical response is defined as clinical response at both Weeks 6 and 52, where clinical response is defined as a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).|Baseline, Weeks 6 and 52|The FAS included all randomized participants who received at least 1 dose of study drug. Participants who only received induction IV therapy and were not randomized into the maintenance phase were not included in the FAS; participants were analyzed according to the randomized treatment assignment.|||percentage of participants||95% Confidence Interval|Number
2564331|NCT02611830|Secondary|Percentage of Participants Achieving Mucosal Healing at Week 52|Mucosal healing is defined as Mayo endoscopic subscore ≤1 point. The findings on endoscopy scale ranges from 0 to 3, where 0=normal or inactive disease 1=mild disease (erythema, decreased vascular pattern, mild friability) 2=moderate disease (marked erythema, lack of vascular pattern, friability, erosions) 3=severe disease (spontaneous bleeding, ulceration).|Week 52|The FAS included all randomized participants who received at least 1 dose of study drug. Participants who only received induction IV therapy and were not randomized into the maintenance phase were not included in the FAS; participants were analyzed according to the randomized treatment assignment.|||percentage of participants||95% Confidence Interval|Number
2564332|NCT02611830|Primary|Percentage of Participants Achieving Clinical Remission at Week 52|Clinical remission is defined as a complete Mayo score ≤ 2 points and no individual subscore > 1 point. The Mayo score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).|Week 52|The Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug. Participants who only received induction IV therapy and were not randomized into the maintenance phase were not included in the FAS; participants were analyzed according to the randomized treatment assignment.|||percentage of participants||95% Confidence Interval|Number
2564333|NCT02611765|Primary|Treatment Success Defined as a Decrease in Rapid Plasma Reagin (RPR) Titer of >= 2 Dilutions (4-fold)|Number of participants who achieve treatment success. Loss to follow-up was assumed to be a failure.|12 months||||participants|||Number
2564334|NCT02611752|Secondary|Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)|"Analysis Results for Unipolar Any Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item At this moment, I fell any drug effects where values can range from 0 (Not at all) to 100 (Extremely)."|15 days|(Completer Population)|||units on a scale||Standard Error|Least Squares Mean
2564366|NCT02610816|Secondary|Percent of Participants With Positive and Negative Milk Skin Prick Tests Responding to 1FED|Reactions to skin prick test (SPT) to milk is positive if the wheal size of the milk test is at least 3 mm larger than the wheal size of the negative control. Treatment response is defined as clinical histologic remission (<15 eos/hpf).|Baseline and 12 weeks|We performed intent to treat analysis including participants who had at least one clinical observation post randomization|||percentage of participants|||Number
2564337|NCT02611752|Secondary|Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w Group (Completer Population)|"Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 32 mg CAM2038 q1w group (Completer Population) , presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item At this moment, I feel bad effects where values can range from 0 (Not at all) to 100 (Extremely)."|15 days|Completer Population|||units on a scale||Standard Error|Least Squares Mean
2564338|NCT02611752|Secondary|Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w Group (Completer Population)|"Analysis of Treatment Phase Unipolar Bad Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) in 24 mg CAM2038 q1w group (Completer Population) , presented as Least Squares (LS) mean with Standard Error (SE) for all 3 doses of hydromorphone in baseline and 4 Challenge Sessions. VAS item At this moment, I feel bad effects where values can range from 0 (Not at all) to 100 (Extremely)."|15 days|Completer Population|||units on a scale||Standard Error|Least Squares Mean
2564339|NCT02611752|Secondary|Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)|"Inferential Analysis Results for Unipolar Good Drug Effects Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) comparing hydromorphone challenge doses in each of the baseling and four challenge sequences with each other, presented as Least Squares (LS) Mean with Standard Error (SE) and 95% Confidence Interval (CI). VAS item At this moment, I feel good drug effects where values can range from 0 (Not at all ) to 100 (Extremely)."|15 days|Completer Population|||units on a scale||95% Confidence Interval|Least Squares Mean
2564340|NCT02611752|Secondary|Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population)|"Inferential Analysis Results for Unipolar High Visual Analog Scale (VAS) for Maximum Effect (Emax) (Completer Population) comparing hydromorphone challenge doses in each of the baseline and four challenge sequence with each other, presented as Least Squares (LS) Mean with Standard Error (SE) and 95% Confidence Interval (CI). VAS item At this moment, I feel high where values can range from 0 (Not at all High) to 100 (Extremely High)."|15 days|Completer Population|||units on a scale||95% Confidence Interval|Least Squares Mean
2564341|NCT02611752|Primary|Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 32 mg|"Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) item At this moment, my liking of this drug is for Qualification/Baseline and Four Challenge sessions (Completer Population) for CAM2038 q1w, 32 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome."|17 days|Mean Drug Liking VAS Scores over Time for CAM2038 q1w 32 mg by Hydromorphone Challenge Session, Completer Population (N=24)|||units on a scale||Standard Error|Least Squares Mean
2564342|NCT02611752|Primary|Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) for Maximum Effect (Emax) Scores for Qualification/Baseline and Four Challenge Sessions (Completer Population) for CAM2038 q1w, 24 mg|"Inferential Analysis Results Drug Liking Visual Analog Scale (VAS) item At this moment, my liking of this drug is for Qualification/Baseline and Four Challenge sessions (Completer Population) for CAM2038 q1w, 24 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome."|17 days|Mean Drug Liking VAS Scores over Time for CAM2038 q1w 24 mg by Hydromorphone Challenge Session, Completer Population (N=22)|||units on a scale||Standard Error|Least Squares Mean
2564343|NCT02611752|Primary|Treatment Phase Drug Liking Visual Analog Scale (VAS) Maximum Effect (Emax) Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 32 mg|"Treatment Phase Drug Liking Visual Analog Scale (VAS) item At this moment, my liking of this drug is for Baseline and Four Challenge sessions Compared to Baseline (Completer Population), where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome."|17 days|Mean Drug Liking VAS Scores over Time for CAM2038 q1w 32 mg by Hydromorphone Challenge Session, Completer Population (N=24)|||units on a scale||Standard Error|Least Squares Mean
2564344|NCT02611752|Primary|Treatment Phase Drug Liking Visual Analog Scale (VAS) Emax Scores for Baseline and Four Challenge Sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg|"Treatment Phase Drug Liking Visual Analog Scale (VAS) item At this moment, my liking of this drug is for Baseline and Four Challenge sessions Compared to Baseline (Completer Population) for CAM2038 q1w, 24 mg, where values can range from 0 (strong disliking) to 100 (strong liking) and 50 is the neutral point. Higher scores mean worse outcome."|17 days|Mean Drug Liking VAS Scores over Time for CAM2038 q1w 24 mg by Hydromorphone Challenge Session, Completer Population (N=22)|||units on a scale||Standard Error|Least Squares Mean
2564345|NCT02611479|Primary|Oswestry Disability Index|"Change in pain and function after spine fusion surgery was measured by the Oswestry Disability Index. Scores range from 0 to 100.~The questionnaire has 10 questions about pain intensity, personal care, lifting ability, walking ability, sitting ability, standing ability, sleeping ability, sex ability, social life, and travelling. Each question is followed by 6 options which describe the amount of disability a patient may face in these situations and the patient marks the statement most applicable to them. Each question is scored on a scale (0-5) with the first option 0 indicating the least amount of disability and 5 indicating the most severe disability. Higher scores indicate worse outcomes, lower scores indicate better outcomes."|Baseline, 60 day, 1 year|140 participants out of the 149 baseline participant population were analyzed since 9 participants were excluded due to incomplete Oswestry Disability Index data.|||score on a scale||Standard Deviation|Mean
2564346|NCT02611154|Secondary|Testosterone Level in Blood as Measured for Safety|Testosterone level in blood to ensure safety levels of testosterone prior to (Day 0) and after the first two weeks of drug administration (Day 19). Steroid levels below the normal range were considered safe to continue study participation.|Day 0 and Day 19||||ng/mL||Full Range|Mean
2564378|NCT02610634|Other Pre-specified|Geriatric Depression Scale (GDS-15)|This involves 15 questions about the mood of the subjects. Scores of 0 to 4 to be in the normal range, 5 to 9 to indicate mild depression, and 10 to 15 to indicate moderate to severe depression.|Session 1 (full session lasts approx. 3 hours)|||||||
2564347|NCT02611154|Secondary|Number of Participants With Suspicious Steroid Profile in Urine Samples at Baseline|"Participants were asked to provide 3 urine samples at Day 1, Day 3, Day 5 to measure their baseline urinary steroid marker levels. To accommodate participant schedules, all baseline samples were collected within a two week timeframe. This outcome is measuring if any participants baseline urine samples resulted in a suspicious steroid profile. For this study, suspicious is defined as any urine sample resulting in testosterone steroid detection above 200ng/mL."|Day 1, Day 3, Day 5||||Participants|||Count of Participants
2564348|NCT02611154|Primary|Steroid Levels in Urine Steroid Profile|"Participants were instructed to follow this dosing pattern:~Begin taking Intranasal Testosterone at Day 1 for 5 consecutive days (Days 1-5), then to take 2 days off (Day 6 and 7) Urine sample at Day 6 Begin taking Intranasal Testosterone at Day 8 for 5 consecutive days (Days 8-12), then to take 3 days off (Day 13, Day 14, Day 15) Urine sample at Day 13 Begin taking Intranasal Testosterone at Day 16 for 5 consecutive days (Days 16-20), then to take 2 days off (Day 21 and 22) Urine sample at Day 21 Begin taking Intranasal Testosterone at Day 23 for 5 consecutive days (Days 23-27 ), then to take 2 days off (Day 28 and 29) Urine sample at Day 28~The first day of the dosing pattern is considered Day 1 and the last day of the pattern is considered Day 29.~Samples 4-8 were analyzed between 0 and 24hours post-dose Sample 9 was analyzed 48 hours post-dose Sample 10 was analyzed 72 hours post-dose Sample 11 was analyzed one week post-dose"|4 weeks of dosing for each participant||||ng/mL||Standard Deviation|Mean
2564349|NCT02610972|Primary|Prevalence of Urine Congophilia Using Congo Red Test GV-005|Prevalence of urine congophilia using Congo Red test GV-005|within 72 hours of urine sample collection||||Participants|||Count of Participants
2564350|NCT02610868|Secondary|Change From Baseline in Drooling Impact Score (DIS)|"The DIS is a 10-item questionnaire with each item rated by the subject to evaluate the impact of sialorrhea on daily activities (e.g., speech, social activities).~Treatment Session (TS)~Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit.~Subject is requested to compare their current status to their last study visit using a 4-point scale ranging from a score of 1, not at all to a score of 4, very much. The DIS total score ranges from 10 to 40. A negative change from baseline indicates a positive clinical outcome."|Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13|"Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U)."|||units on a scale||Standard Deviation|Mean
2564351|NCT02610868|Secondary|Patient Global Impression of Change (PGI-C)|"The PGI-C scale will be used by the subject to rate the change in symptoms of his/her illness (sialorrhea) on an 7-point scale ranging from a score of 1, very much improved to a score of 7, very much worse.~Treatment Session (TS)~Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit."|TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13|"Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U)."|||units on a scale||Standard Deviation|Mean
2564352|NCT02610868|Secondary|Change From Baseline in Patient Global Impression of Severity (PGI-S)|"The PGI-S scale will be used by the subject to rate the severity of his/her illness (sialorrhea) on an 7-point scale ranging from a score of 1, normal to a score of 7, among the most extremely ill.~Treatment Session (TS)~Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit."|Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13|"Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U)."|||units on a scale||Standard Deviation|Mean
2564353|NCT02610868|Secondary|Change From Baseline in Drooling Frequency and Severity Scale Performed by Subject (DFSS-S)|"The DFSS will be used to assess the frequency and severity of drooling on a 5-point scale ranging from a score of 1, dry never drools to a score of 5, profuse clothing hands tray objects become wet. Drooling frequency will be assessed on a 4-point scale ranging from a score of 1, never drools to a score of 4, constantly drools.~Treatment Session (TS)~Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit.~The severity score and frequency score are summed together to create the DFSS total score (range 2 -9). A decrease from baseline indicates improvement."|Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13|"Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U)."|||units on a scale||Standard Deviation|Mean
2564354|NCT02610868|Secondary|Change From Baseline in Drooling Frequency and Severity Scale Performed by Trained Assessor (DFSS-I)|"The DFSS will be used to assess the frequency and severity of drooling on a 5-point scale ranging from a score of 1, dry never drools to a score of 5, profuse clothing hands tray objects become wet. Drooling frequency will be assessed on a 4-point scale ranging from a score of 1, never drools to a score of 4, constantly drools.~Treatment Session (TS)~Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.~The severity score and frequency score are summed together to create the DFSS total score (range 2-9). A decrease from baseline indicates improvement."|Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13|"Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U)."|||units on a scale||Standard Deviation|Mean
2564379|NCT02610634|Other Pre-specified|Addenbrookes Cognitive Examination (ACE-R)|The ACE-R involves testing of attention, orientation, memory, fluency, language and visuospatial abilities.|Session 1 (full session lasts approx. 3 hours)|||||||
2564380|NCT02610634|Other Pre-specified|Montreal Cognitive Assessment (MoCA)|Different cognitive domains are assessed (attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation).|Session 1 (full session lasts approx. 3 hours)|||||||
2564355|NCT02610868|Secondary|Clinical Global Impression of Change (CGI-C)|"CGI-C will be used to record change or improvement of illness (sialorrhea) on a 7-point scale ranging from a score of 1, very much improved to a score of 7, very much worse.~Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.~Treatment Session (TS)"|TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13|"Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U)."|||units on a scale||Standard Deviation|Mean
2564356|NCT02610868|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S)|"CGI-S will be used to record the severity of illness (sialorrhea) on a 7-point scale ranging from a score of 1, normal to a score of 7, among the most extremely ill patients.~Treatment Session (TS)~Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit."|Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13|"Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U)."|||units on a scale||Standard Deviation|Mean
2564357|NCT02610868|Secondary|Change From Baseline in Unstimulated Salivary Flow Rate (USFR): Treatment Sessions 1-4|"For Treatment Sessions 2-4, the change from baseline is calculated using the Week 13 value from the previous Treatment Session as the new baseline. Week 8 was only assessed in Treatment Session 1.~Treatment Session (TS)~Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit."|Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13|"Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U)."|||g/minute||Standard Deviation|Mean
2564358|NCT02610868|Primary|Occurrence of Dental Adverse Events|Treatment Session (TS)|Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1|"Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U)."|||participants|||Number
2564359|NCT02610868|Primary|Columbia Suicide Rating Scale (C-SSRS): Suicidal Ideation, Behavior Scores and Intensity Scores|"Participants Analyzed does not match the Participant Flow because one participant discontinued prior to the first post-injection visit.~Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U)."|Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13||||participants|||Number
2564360|NCT02610868|Primary|Occurrence of Adverse Events of Special Interest (AESI)|"Treatment Session (TS)~AESI includes: Aspiration, Aspirational pneumonia, Choking and Dysphagia."|Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1|"Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U)."|||participants|||Number
2564361|NCT02610868|Primary|Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE)|"TEAEs Related to Study Medication include TEAEs classified as Possibly, Probably and Definitely Related.~Treatment Session (TS)"|Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1|"Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.~All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U or 3000 U)."|||participants|||Number
2564362|NCT02610842|Secondary|Scleroderma Health Assessment Questionnaire|"The Health Assessment Questionnaire, is a self-administered 20-questionnaire that assesses functional ability in eight domains. Questions in each domain are scored in a four-point scale, from 0 (without difficulty) to 3 (unable to do). The maximum score from each domain is added together and divided by the number of categories completed (score ranging from 0 -better to 3 - worse). The Scleroderma Health Assessment Questionnaire (SHAQ) consists of the 20 items from the HAQ and has five additional questions that assess symptoms caused by Systemic Sclerosis (Raynaud Phemonomenon, digital tip ulcers, gastrointestinal and lung symptoms, as well as overall disease symptoms) using visual analogue scales (VAS). Scores on the VAS range from 0 (does not interfere with activities) to 3 (very severe limitations with activities). The overall score is the sum of each of the five VAS sub scores and the scores for the eight HAQ domains divided by 13. The SHAQ index ranges from 0 to 3."|8 weeks||||units on a scale||Standard Deviation|Mean
2564363|NCT02610842|Secondary|Delta Finger-to-palm|The standard finger-to-palm (FTP) measurement is obtained using a ruler to measure the distance (in centimeters)between the tip of the pulp on the 3rd finger and the distal palmar crease while the patient attempts to make a full fist (maximal finger flexion at all 3 finger joints: MCP, PIP, and DIP). The delta FTP is finger extension, the distance between the 3rd fingertip and the distal palmar crease while the patient attempts full finger extension, minus the FTP.|8 weeks||||Centimeters||Standard Deviation|Mean
2564364|NCT02610842|Primary|Visual Analogue Pain Scale|Hand pain (pain-VAS) was assessed using a 10 cm horizontal pain scale. Pain severity was rated from 0-10, where 0 = no pain and 10 = very severe pain|8 weeks||||units on a scale||Standard Deviation|Mean
2564365|NCT02610842|Primary|Cochin Hand Functional Scale|"The purpose of this self-report scale is to measure functional ability in the hand.~The questions ask how much difficulty the person has performing 18 tasks without the help of any assistive device. Kitchen tasks include holding a bowl and a plate full of food, pouring liquid, cutting meat, and peeling fruit. The dressing items include buttoning and opening/closing a zipper. The hygiene items include squeezing a tube of toothpaste and holding a toothbrush. Office items include 2 writing tasks, while other items include turning a doorknob, cutting with scissors, and turning a key in a lock. Score range is from 0-90. A higher score indicates greater disability or more difficulty, whereas a lower score indicates less disability or difficulty."|08 weeks||||units on a scale||Standard Deviation|Mean
2564367|NCT02610816|Secondary|Change From Baseline in Endoscopic Reference Score at 12 Weeks|The EoE Endoscopic Reference Score (EREFS) measures features of EoE including esophageal edema, rings, exudate, furrows, and strictures. The instrument grades edema and furrows as absent (0) or present (1); rings as absent (0), mild (1, subtle circumferential ridges), moderate (2, distinct rings) and severe (3, rings that impair passage of a standard adult diagnostic endoscope); exudates as absent (0), mild (1, less than 10% of the esophageal surface area) or severe (2, greater or equal to 10% of the esophageal surface area); and strictures as absent (0) or present (1) with an estimation of the minimal luminal diameter. Higher scores indicate more severe disease (range 0 - 9). Scores were obtained at baseline and 12 weeks. Change in score is defined as the EREFS total score at 12 weeks minus total score at baseline. 1FED vs 4FED changes are compared. A reduction in score (negative change) is indicative of a reduction in esophageal abnormalities.|Baseline and 12 weeks|We performed intent to treat analysis including participants who had at least one clinical observation post randomization|||units on a scale||Standard Deviation|Mean
2564368|NCT02610816|Secondary|Change From Baseline in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0) Generic Core Scales at 12 Weeks|The PedsQL 4.0 measures physical and psychosocial function. The range for PedsQL 4.0 scores is 0 to 100, with a higher score indicating better quality of life. Scores were obtained at baseline and 12 weeks. Change in score is defined as the PedsQL 4.0 total score at 12 weeks minus total score at baseline. 1FED vs 4FED changes are compared. An increase in score (positive change) is indicative of improved quality of life.|Baseline and 12 weeks|We performed intent to treat analysis including participants who had at least one clinical observation post randomization|||units on a scale||Standard Deviation|Mean
2564369|NCT02610816|Secondary|Change From Baseline in Pediatric Quality of Life Inventory Version 3.0 EoE Module (PedsQL 3.0 EoE) at 12 Weeks|The PedsQL 3.0 EoE measures symptoms and problems related to treatment, worry, communication, food/eating, and feelings. The range for PedsQL 3.0 EoE scores is 0 to 100, with a higher score indicating better quality of life. Scores were obtained at baseline and 12 weeks. Change in score is defined as the PedsQL 3.0 EoE total score at 12 weeks minus total score at baseline. 1FED vs 4FED changes are compared. An increase in score (positive change) is indicative of improved quality of life.|Baseline and 12 weeks|We performed intent to treat analysis including participants who had at least one clinical observation post randomization|||units on a scale||Standard Deviation|Mean
2564370|NCT02610816|Secondary|Percent of 1FED Non-responders on 4FED in Histologic Remission (<15 Eos/Hpf) at 12 Weeks in Phase 2|Percent of 1FED non-responders on 4FED in histologic remission in phase 2. Remission is defined as esophageal peak eosinophil count < 15 eosinophils per high powered field. Complete remission is defined as ≤ 1 peak eos/hpf and partial remission as 2 - 14 peak eos/hpf.|12 weeks|We performed Intent to treat analysis including participants who had at least one clinical observation post randomization.|||percentage of participants|||Number
2564371|NCT02610816|Secondary|Percent of Participants on Swallowed Glucocorticoids (SGC) in Histologic Remission (<15 Eos/Hpf) at 12 Weeks in Phase 2|Percent of 4FED non-responders on SGC in Phase 2 in histologic remission. Remission is defined as esophageal peak eosinophil count < 15 eosinophils per high power field (eos/hpf). Complete remission is defined as ≤ 1 peak eos/hpf and partial remission as 2 - 14 peak eos/hpf.|12 weeks|We performed intent to treat analysis including participants who had at least one clinical observation post randomization|||percentage of participants|||Number
2564372|NCT02610816|Secondary|Percent of Participants in Histologic Remission (<15 Eosinophils Per High Power Field) at 12 Weeks|Percent of participants in remission in 1FED and 4FED groups. Remission is defined as clinical esophageal peak eosinophil count < 15 eosinophils per high power field (eos/hpf). Complete remission is defined as ≤ 1 peak eos/hpf and partial remission as 2 - 14 peak eos/hpf.|12 weeks|We performed intent to treat analysis including participants who had at least one clinical observation post randomization.|||percentage of participants|||Number
2564373|NCT02610816|Primary|Within-group Comparisons (Baseline v. Week 12) of PEESS V2.0 Scores|The PEESS V2.0 questionnaire captures EoE-specific symptoms. The range for PEESS v2.0 scores is 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms. Baseline vs Week 12 scores are compared within each treatment group (1FED and 4FED).|Baseline and 12 weeks|We performed intent to treat analysis including participants who had at least one clinical observation post randomization|||units on a scale||Standard Deviation|Mean
2564374|NCT02610816|Primary|Change From Baseline in Pediatric EoE Symptom Score Version 2.0 (PEESS V2.0) at 12 Weeks|The PEESS V2.0 questionnaire captures EoE-specific symptoms (dysphagia, gastro-esophageal reflux disease (GERD), nausea/vomiting, and pain) as reported by children with EoE (8-18 years of age) and their parents (for children 2-18 years of age). The range for PEESS v2.0 scores is 0 to 100, with a higher score being indicative of more frequent and/or severe symptoms. Scores were obtained at baseline and 12 weeks. Change in score is defined as total score at 12 weeks minus total score at baseline. The parent-proxy PEESS total score change from pre-treatment to post-treatment is the primary efficacy endpoint. 1FED vs 4FED changes are compared. A reduction in score (negative change) is indicative of a reduction in symptoms.|Baseline and 12 weeks|We performed intent to treat analysis including participants who had at least one clinical observation post randomization.|||units on a scale||Standard Deviation|Mean
2564375|NCT02610725|Secondary|Adverse Event Questionnaire|A free response survey asking for detail on any pain or injuries that may be relevant or related to the online yoga class|Post-Intervention||||Participants|||Count of Participants
2564376|NCT02610725|Secondary|Feasibility/Acceptability Questionnaire|"This measure was developed for this study. It includes a Likert Scale item assessing how much participants liked the class (1 Disliked it very much to 10 Liked it very much). It also collects qualitative feedback on what they liked, disliked, as well as any other commentary. Quantitative data from Likert items are the secondary outcome reported."|Post-Intervention||||units on a scale||Standard Deviation|Mean
2564377|NCT02610725|Primary|Positive and Negative Affect Scale|The PANAS is a 20-item questionnaire that contains two 10-item subscales for positive and negative affect, respectively. The positive affect subscale assesses domains of excitement, enthusiasm, and attentiveness, whereas the negative subscale measures domains of distress, guilt, and irritability. Each subscale score can range from 10-50 where higher scores indicate greater levels of affect.|Pre- and post-intervention, 40 min|140 participants completed the PANAS at pre-intervention. 52 had valid data at post-intervention|||units on a scale||Standard Deviation|Mean
2564385|NCT02610634|Other Pre-specified|Contrast Sensitivity|CS will be measured using the Mars CS sheets placed on an adjustable holder. The sheet consists of 48 Latin letters of uniform height; the contrast from the white background decreases with subsequent letters. Room illumination is adjusted so that average CS sheet luminance is between 80 and 120cd/m² (measured via a luminance meter). Assessment is done binocularly with the average distance from the patients eyes being 50cm. Participants read aloud down the sheet starting at the top left. Errors are recorded on the pre-set score sheet and testing is terminated after 2 consecutive errors.|Session 1 (full session lasts approx. 3 hours)|||||||
2564386|NCT02610634|Other Pre-specified|Visual Acuity|VA is measured binocularly used a standard LogMAR chart. Participants will be seated at a distance of 4m from the chart. Participants will be instructed to read aloud down the chart starting from the top left.|Session 1 (full session lasts approx. 3 hours)|||||||
2564387|NCT02610634|Other Pre-specified|Visual Object and Space Perception Battery (VOSP)|This study will use a selection of these tests; incomplete letters, dot counting and position discrimination.|Session 1 (full session lasts approx. 3 hours)|||||||
2564388|NCT02610634|Other Pre-specified|Clock Copying (CLOX 1 and 2)|Participants are required to draw a clock with the numbers and arrows pointed at a particular time. Then the subjects have to copy a clock drawn by the researcher.|Session 1 (full session lasts approx. 3 hours)|||||||
2564389|NCT02610634|Other Pre-specified|Benton's Judgement of Line Orientation (JLO) Test|JLO is a test of visuospatial ability, which involves a subject viewing a set of numbered lines and then being shown two lines of the same orientation. Participants then have to name the numbers that the shown lines correspond to.|Session 1 (full session lasts approx. 3 hours)|||||||
2564390|NCT02610634|Other Pre-specified|CDR Attention Battery (Cognitive Drug Research - CDR, United Biosource Corporation, UK)|The Attention CDR involves a series of computerised tests, which the subjects respond to by pressing one of two buttons. Scores for sub-sections of Simple reaction time, Digit vigilance and Choice reaction time will be obtained.|Session 1 (full session lasts approx. 3 hours)|||||||
2564391|NCT02610634|Secondary|Visual Sampling Parameter: Number of Blinks During Gait|Number of blinks observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins) and one week later in Session 2 for a sub-group (PD and controls n = upto 25) (lasting approx. 60mins)|||||||
2564392|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Duration During Gait|Duration (ms) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
2564393|NCT02610634|Secondary|Visual Sampling Parameter: Fixation Duration During Gait|Duration (ms) of pauses (fixations) between fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
2564394|NCT02610634|Secondary|Visual Sampling Parameter: Fixation Number During Gait|Number of pauses (fixations) between fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
2564395|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Acceleration During Gait|Acceleration (degrees per second squared) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
2564396|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Amplitude During Gait|Distance (degrees) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
2564397|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Velocity During Gait|Velocity (degrees per second) of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
2564398|NCT02610634|Secondary|Visual Sampling Parameter: Saccade Number During Gait|Number of fast eye movements observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins) and one week later in Session 2 for a sub-group (PD and controls n = upto 25) (lasting approx. 60mins)|||||||
2564399|NCT02610634|Secondary|Gait Parameter: Double Support Time|Measured in seconds recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
2564400|NCT02610634|Secondary|Gait Parameter: Single Support Time|Measured in seconds recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
2564401|NCT02610634|Secondary|Gait Parameter: Step Time|Measured in seconds recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins) and one week later in Session 2 for a sub-group (PD and controls n = upto 25) (lasting approx. 60mins)|||||||
2564402|NCT02610634|Secondary|Gait Parameter: Step Length|Measured in meters recorded via Vicon 3D motion capture. Observed during the following walking conditions; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)|||||||
2564404|NCT02610634|Primary|Visual Sampling Parameter: Saccade Frequency During Gait|Number of fast eye movements made per second observed when walking, measured via EOG and Dikablis mobile eye-tracker. Walking conditions include; single task, dual task, through a doorway, whilst turning and with a visual cue in place.|Session 1: observation during gait assessments (lasting approx. 90mins)||||Saccade frequency (sacc/sec)||Standard Deviation|Mean
2564405|NCT02610231|Secondary|Patient Global Impression - Overall Condition (Improvement by Study Visit) (ITT Analysis Set).|The number and percentage of subjects showing improvement (moderate or mild) on PGI-I scores with Istradefylline 20 mg or 40 mg. Each subjects 'key symptom' (the symptom they had most trouble with) on the PGI-I was identified and evaluated at baseline and at Week 12, 26 and 52. In addition, the subject's overall condition and symptoms of fatigue, sleep and motivation to get things done were also evaluated at week 12, 26 and 52. Subjects rated each on a scale 1 to 5 for change from baseline status utilizing the following scale: 1= Moderate improvement (or greater) 2= Mild improvement, 3= No change from baseline, 4 = Mild deterioration, 5= Moderate deterioration (or greater).|From baseline through to study completion at week 52, plus 30 days post last dose||||Participants|||Count of Participants
2564406|NCT02610231|Primary|Evaluation of the Long-term Safety and Tolerability of Oral Istradefylline (20mg or 40mg/Day [mg/d])|The number of subjects experiencing an adverse event as well as clinical laboratory tests (chemistry, haematology and urinalysis) were collected to evaluate the safety profile of istradefylline (20mg or 40mg/day [mg/d]).|From screening through to study completion, an average of 52 weeks|All participants who received at least one dose of assigned study drug (even a partial dose) made up the Safety Analysis Set.|||Participants|||Count of Participants
2564407|NCT02610192|Secondary|Activity Measured With UCLA Activity Score Questionnaire at 1, 3, 6 and 12 Months|"The UCLA Activity Score is a validated measure of subject activity. Subjects rate their current activity level from on a simple scale ranging from 1 to 10. The subject indicated her or his most appropriate activity level, with 1 defined as no physical activity, dependent on others and 10 defined as regular participation in impact sports"|Baseline, 1, 3, 6 and 12 Months|Analyses were performed on available data, with no imputation for missing data.|||score on a scale||Standard Deviation|Mean
2564408|NCT02610192|Secondary|Patellofemoral Pain and Function Measured With Kujala Anterior Knee Pain Assessment Questionnaire (KAKPAQ) Questionnaire at 1, 3, 6 and 12 Months|The KAKPAQ is a 13-item screening instrument designed to assess patellofemoral pain and instability in adolescents and young adults, with a variable ordinal response format (3-5 choices). The questions included knee functional ability; limping, weight bearing, walking, stairs, squatting, running, jumping, prolonged sitting, pain swelling, painful patellar movement, muscle atrophy and flexion deficiency. Each answer had different scores. To calculate the total score, all items were summarized. The score '0' represented the greatest limitation of knee function, whereas the score '100' indicated the ability to perform most knee functions|Baseline, 1, 3, 6 and 12 Months|Analyses were performed on available data, with no imputation for missing data.|||score on a scale||Standard Deviation|Mean
2564409|NCT02610192|Secondary|Function Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Function at 1, 3, 6 and 12 Months|"The NRS is a validated measure of pain, stiffness and function. The NRS is an 11 point Likert type scale anchored by 0 no pain and 10 worst possible pain. Subjects rate their average pain over the last 24 hours. Likewise subjects rate their stiffness and function on an 11 point Likert type scale"|Baseline, 1, 3, 6 and 12 Months|Analyses were performed on available data, with no imputation for missing data.|||score on a scale||Standard Deviation|Mean
2564410|NCT02610192|Secondary|Stifness Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Stiffness at 1, 3, 6 and 12 Months|"The NRS is a validated measure of pain, stiffness and function. The NRS is an 11 point Likert type scale anchored by 0 no pain and 10 worst possible pain. Subjects rate their average pain over the last 24 hours. Likewise subjects rate their stiffness and function on an 11 point Likert type scale"|Baseline, 1, 3, 6 and 12 Months|Analyses were performed on available data, with no imputation for missing data.|||score on a scale||Standard Deviation|Mean
2564411|NCT02610192|Secondary|Pain Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months|"The NRS is a validated measure of pain, stiffness and function. The NRS is an 11 point Likert type scale anchored by 0 no pain and 10 worst possible pain. Subjects rate their average pain over the last 24 hours. Likewise subjects rate their stiffness and function on an 11 point Likert type scale"|Baseline, 1, 3, 6 and 12 Months|Analyses were performed on available data, with no imputation for missing data.|||score on a scale||Standard Deviation|Mean
2564412|NCT02610192|Secondary|Quality of Life (QoL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale QoL at 1, 3, 6 and 12 Months|The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. The original KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QoL) (4 questions). On this scale, 100% indicates no problems and 0% indicates extreme problems|Baseline, 1, 3, 6 and 12 Months|Analyses were performed on available data, with no imputation for missing data.|||score on a scale||Standard Deviation|Mean
2564413|NCT02610192|Secondary|Function in Sport and Recreation (Sport/Rec) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Sport/Rec at 1, 3, 6 and 12 Months|The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. The original KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QoL) (4 questions). On this scale, 100% indicates no problems and 0% indicates extreme problems|Baseline, 1, 3, 6 and 12 Months|Analyses were performed on available data, with no imputation for missing data.|||score on a scale||Standard Deviation|Mean
2564414|NCT02610192|Secondary|Function in Daily Living (ADL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale ADL at 1, 3, 6 and 12 Months|The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. The original KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QoL) (4 questions). On this scale, 100% indicates no problems and 0% indicates extreme problems|Baseline, 1, 3, 6 and 12 Months|Analyses were performed on available data, with no imputation for missing data.|||score on a scale||Standard Deviation|Mean
2564415|NCT02610192|Secondary|Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Symptoms at 1, 3, 6 and 12 Months|The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. The original KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QoL) (4 questions). On this scale, 100% indicates no problems and 0% indicates extreme problems|Baseline, 1, 3, 6 and 12 Months|Analyses were performed on available data, with no imputation for missing data.|||score on a scale||Standard Deviation|Mean
2564416|NCT02610192|Primary|Pain Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months|The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. The original KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QoL) (4 questions). On this scale, 100% indicates no problems and 0% indicates extreme problems.|Baseline, 1, 3, 6 and 12 Months|Analyses were performed on available data, with no imputation for missing data.|||score on a scale||Standard Deviation|Mean
2564417|NCT02609841|Secondary|Incidence of Cardiac Arrhythmias|Incidence of serious cardiac arrhythmias in patients during the observational period. Serious arrhythmias defined as ventricular tachycardia or > 5 sec pause.|12 days|Patients who received all 6 hemodialysis treatments and wore Body Guardian Device, a non-invasive wearable remote cardiac rhythm monitoring system|||% of patients|||Number
2564418|NCT02609841|Secondary|Incidence of Pre-dialysis Hyperkalemia (HK) After the Long Inter-dialytic Period (LIDP) in Patients on ≥3K Dialysate.|Incidence of pre-dialysis hyperkalemia (HK) in patients after the long inter-dialytic period (LIDP) in patients on ≥3K dialysate. Hyperkalemia defined as serum potassium (S-K) >5.0 mEq/L.|12 days|Per protocol population|||% of patients|||Number
2564419|NCT02609841|Primary|Incidence of Pre-dialysis HK After the LIDP in <3K Dialysate Patients|Incidence of pre-dialysis hyperkalemia (HK) in patients after the long inter-dialytic period (LIDP) in patients on <3K dialysate. Hyperkalemia defined as serum potassium (S-K) >5.0 mEq/L.|12 Days|Per Protocol Population: all enrolled subjects who receive 6 dialysis treatments within the 12-day study period|||Percent of participants|||Number
2564420|NCT02609672|Secondary|Change in Cardiovascular Fitness|Cardiovascular fitness will be calculated using the Single Stage Treadmill Walking Test. Predictions of VO2max will be made from heart rate (measured with a heart rate monitor), walking speed, age and gender.|Week 1 and Week 13|Due to equipment problems, 2 participants from the Exercise Group were not able to complete the Single Stage Treadmill Walking Test.|||Change in ml/kg/min||Standard Deviation|Mean
2564421|NCT02609672|Secondary|Change in Isometric Knee and Hip Extensor and Flexor Strength|The peak torque developed during knee and hip extension and flexion during a maximum isometric contraction will be measured by use of a Biodex System 2 isokinetic dynamometer. Data will be presented as Nm/kg (torque/body mass).|Week 1 and Week 13||||Change in Nm/kg||Standard Deviation|Mean
2564422|NCT02609672|Secondary|Change in Grip Strength (Relative)|Grip strength will be assessed using a Jamar hand dynamometer. The hand dynamometer will be set to a fixed position and all values of grip force will be expressed in kg/kg (grip force/body mass).|Week 1 and Week 13||||Change in kg/kg||Standard Deviation|Mean
2564423|NCT02609672|Secondary|Change in Grip Strength (Absolute)|Grip strength will be assessed using a Jamar hand dynamometer. The hand dynamometer will be set to a fixed position and all values of grip force will be expressed in kg.|Week 1 and Week 13||||Change in kg||Standard Deviation|Mean
2564424|NCT02609672|Secondary|Change in Depression Status|Depression will be assessed with the Centre of Epidemiological Studies Depression (CES-D) Scale, a 20-item scale developed for the general population with emphasis on affect. Elements of affect include mood, guilt, worthlessness, helplessness, appetite, and sleep. Each item is scored from 0 (rarely or none of the time), to 3 (most of the time). The items are summed to produce a total score between 0 and 60 with a score of 16 or higher indicating depression.|Week 1 and Week 13||||Change in scores on a scale||Standard Deviation|Mean
2564425|NCT02609672|Secondary|Change in Arthritis-related Self-efficacy|The Arthritis Self-Efficacy Scale (ASES) measures arthritis-specific beliefs regarding perception of performance on certain tasks to cope with the disease. The ASES is measured using 20 questions on a 10-100 scale with respect to three main areas: pain management (5 questions), physical function (9 questions), and other symptoms (6 questions). Each question is scored from 10 (very uncertain), to 100 (very certain), in 10-point increments. The minimum score for each subscale is 10, and the maximum score for each subscale is 100. The scores from each subscale are averaged to produce a normalized total score. Scores closer to 100 indicate greater certainty that a participant can cope with a particular task as a consequence of their disease.|Week 1 and Week 13||||Change in scores on a scale||Standard Deviation|Mean
2564426|NCT02609672|Secondary|Change in Mobility Performance (Timed Up and Go Test)|Mobility performance will be measured using the Timed Up and Go Test. This test measures the time taken to rise from a standard chair with arm rests, walk 3 metres, and return to a seated position. This measure has produced reliable and valid data in persons with knee OA.|Week 1 and Week 13||||Change in Seconds||Standard Deviation|Mean
2564427|NCT02609672|Secondary|Change in Mobility Performance (30-second Chair Stand Test)|Mobility performance will be measured using the 30-second Chair Stand Test. This test measures the number of times participants can rise and lower from a standard height chair, without using arm rests, in a 30-second period.This measure has produced reliable and valid data in persons with knee OA.|Week 1 and Week 13||||Change in number of sit-to-stand cycles||Standard Deviation|Mean
2564428|NCT02609672|Secondary|Change in Mobility Performance (Stair Descent)|Mobility performance will be measured using the Stair Descent Test. For this test, the time taken to descend nine stairs is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.|Week 1 and Week 13||||Change in Seconds||Standard Deviation|Mean
2564429|NCT02609672|Secondary|Change in Mobility Performance (Stair Ascent)|Mobility performance will be measured using the Stair Ascent Test. For this test, the time taken to ascend nine stairs is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.|Week 1 and Week 13||||Change in Seconds||Standard Deviation|Mean
2564430|NCT02609672|Secondary|Change in Mobility Performance (40 Metre Walk Test)|Mobility performance will be measured using the 40 Metre Walk Test. This test measures the time taken to complete a fast-paced 40 metre walk. The time taken to walk 40 metres is recorded in seconds. This measure has produced reliable and valid data in persons with knee OA.|Week 1 and Week 13||||Change in Seconds||Standard Deviation|Mean
2564431|NCT02609672|Secondary|Change in Mobility Performance (Six-Minute Walk Test)|Mobility performance will be measured using the Six-Minute Walk Test (6MWT). For this test, participants are instructed to walk as far as possible in 6 minutes. The distance covered in 6 minutes is recorded in metres. This measure has produced reliable and valid data in persons with knee OA.|Week 1 and Week 13||||Change in Metres||Standard Deviation|Mean
2564432|NCT02609672|Secondary|Change in Resilience|Resilience will be measured using the Resilience Scale 25 Survey, which is a 25-item questionnaire designed to evaluate a participants ability to adapt to stress and adversity. The test is scored out of 175 (scores ranging from 25 to 175), with higher scores indicating higher resilience.|Week 1 and Week 13||||Change in scores on a scale||Standard Deviation|Mean
2564433|NCT02609672|Secondary|Change in Self-reported Knee and Hip Pain|Change in self-reported knee and hip pain will be assessed with 3 valid and reliable questionnaires: the Knee injury and Osteoarthritis Outcome Score (KOOS), the Hip disability and Osteoarthritis Outcome Score (HOOS), and the Intermittent and Constant Osteoarthritis Pain (ICOAP) score. The KOOS and HOOS pain scores represent a normalized score from 0 (extreme symptoms) to 100 (no symptoms). KOOS and HOOS scores closer to 100 indicate fewer symptoms. The ICOAP consists of two sub-scales: constant pain (5 items) and intermittent pain (6 items). The score from each subscale represents a normalized score from 0 (no pain) to 100 (extreme pain). ICOAP scores closer to 0 indicate less pain. The items from each subscale are averaged to produce a normalized ICOAP total score, ranging from 0 (no pain) to 100 (extreme pain).|Week 1 and Week 13||||Change in scores on a scale||Standard Deviation|Mean
2564434|NCT02609672|Primary|Change in Lower Extremity Function|The Lower Extremity Function Scale (LEFS) consists of 20 items, on an adjectival scale, that assess difficulty during mobility tasks ranging from transfers to running. Each item is scored from 0 (extreme difficulty or unable to perform activity), to 4 (no difficulty to perform activity). The minimum possible score is 0, and the maximum possible score is 80. Scores closer to 80 represent better self-reported physical function. It is reliable and valid in knee OA and has superior sensitivity to change compared to similar measures.|Week 1 and Week 13||||Change in scores on a scale||Standard Deviation|Mean
2564435|NCT02609659|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug, excluding reinfection, among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants|||Number
2564436|NCT02609659|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment.|Up to 12 weeks|All participants who received at least 1 dose of study drug (ITT population).|||percentage of participants|||Number
2564437|NCT02609659|Primary|Mean Change in Hemoglobin Values From Baseline to End of Treatment|The mean change in hemoglobin (g/L) from baseline to each study visit and to the final treatment visit (up to 12 weeks) is provided.|Baseline (Day 1) to Weeks 2, 4, 8, and 12, and the Final Treatment Visit (up to 12 weeks)|All participants who received at least 1 dose of study drug (ITT population) with a hemoglobin value at baseline and at given timepoint.|||g/L||Standard Deviation|Mean
2564438|NCT02609659|Primary|Percentage of Participants With Hemoglobin < 10 g/dL During Treatment|The percentage of participants with hemoglobin <10 g/dL during treatment is provided.|up to 12 weeks|All participants who received at least 1 dose of study drug (ITT population) with at least one post-baseline hemoglobin value through the final treatment value.|||percentage of participants|||Number
2564439|NCT02609659|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in participants in the treatment arm 3-DAA + RBV 600 mg) for 12 weeks compared with the historical control rate for subjects treated with 3-DAA + weight-based RBV for 12 weeks.|12 weeks after the last actual dose of study drug|Intent-to-treat population: all participants who received at least 1 dose of study drug; participants with missing data after flanking imputation were counted as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2564440|NCT02609633|Secondary|Percentage of Participants With Overall Treatment Satisfaction With the Use of Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire|Percentage of participants with overall treatment satisfaction with the use of Accu-Chek® CONNECT Diabetes Management system according to the questionnaire answered by children/adolescents and parents were reported.|Month 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analyzed' is the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2564449|NCT02609633|Secondary|Change From Baseline in Diabetes-Related Distress Among School-age Children/Adolescents and Adolescents According to the PAID C&T Child Questionnaire Score at Month 3 and 6|"The PAID Questionnaire encompassed 26 items. Score for each question ranges from 1-2 = Not a Problem to 5-6 = Big Problem (Child version) or 1-2 = Not a Problem to 5-6 = Serious Problem (Teen or Parent versions). The derived total score (26 questions) ranges between 26 and 156, where higher score indicates worsened condition."|Baseline, Months 3 and 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analysed' is the participants who were evaluable for this outcome measure.|||score on a scale||Standard Deviation|Mean
2564441|NCT02609633|Secondary|Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process|Participants preference the Accu-Chek® CONNECT process compared with previous technology/process assessed by questionnaire including following questions; Q 1: Felt more sure of myself using the system, Q 2: Less worried about low BG than used to be, Q 3: Would rather use the system than what used before, Q 4: Felt safer managing diabetes using system than what used before, Q 5: Friends with diabetes should also use the system. Questionnaire was answered by children/adolescents and parents. Here, in children/adolescents post questionnaire for preference the percentage sum is not equal to 100%, because percentage is based on n=41.|Month 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'number analyzed' is the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2564442|NCT02609633|Secondary|Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability|Percentage of participants who frequently used Accu-Chek® CONNECT Diabetes Management System (blood sugar meter [BSM], phone application [PA] and web portal [WP]) according to the questionnaire about usability answered by children/adolescents and Parent were reported. Here, in parent post questionnaire for usability the sum of percentages are not equal to 100%, because percentage is based on n=44.|Month 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analyzed' is the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2564443|NCT02609633|Secondary|Change From Baseline in Percentage of Hypoglycemic BG Measurements Among School-Age Children With Diabetes at Months 3 and 6|A measurement was defined as hypoglycemic if the glucose value was below 70 mg/dl or below 60 mg/dl or below 50 mg/dl.|Baseline, Months 3 and 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analysed' is the participants who were evaluable for this outcome measure.|||percentage of hypoglycemic measurements||Standard Deviation|Mean
2564444|NCT02609633|Secondary|Change From Baseline Blood Glucose Variability Among School-Age Children With Diabetes at Months 3 and 6|Glycemic variability, expressed as mean of all blood glucose(BG) readings per subject within the interval. BG variability was defined as standard deviation (SD) of all glucose readings over the interval.|Baseline, Months 3 and 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'number analysed' is the participants who were evaluable for this outcome measure.|||milligrams per deciliter (mg/dl)||Standard Deviation|Mean
2564445|NCT02609633|Secondary|Change From Baseline in Percentage of Blood Glucose (BG) Measurements Among School-Age Children With Diabetes at Months 3 and 6 Within Glucose Target Range|The percentage of target range measurements was defined as the number of within target range readings in the interval divided by the total number of BG checks in the interval.|Baseline, Months 3 and 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. The number analysed is the participants who were evaluable for this outcome measure.|||percentage of blood glucose measurements||Standard Deviation|Mean
2564446|NCT02609633|Secondary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) Among School-Age Children With Diabetes at Months 3 and 6|Assessment of HbA1c is an indicator of long-term control of diabetes.|Baseline, Months 3 and 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analysed' is the participants who were evaluable for this outcome measure.|||percentage of glycated hemoglobin||Standard Deviation|Mean
2564447|NCT02609633|Secondary|Change From Baseline in Affect Towards Blood Glucose Monitoring Among School-Age Children With Diabetes and Parent/Caregiver According to Blood Glucose Monitoring Communication (BGMC) Parent Questionnaire Score at Months 3 and 6|"The BGMC Questionnaire has 8 questions, each question ranges in response values from 1 (Almost Never) to 3 (Almost Always). The derived total score ranges between 8 and 24, where higher score indicates worsened condition."|Baseline, Months 3 and 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'number analysed' is the participants who were evaluable for this outcome measure.|||score on a scale||Standard Deviation|Mean
2564448|NCT02609633|Secondary|Change From Baseline in Perceived Family Conflict Among School-Age Children With Diabetes and Parent/Caregiver According to Diabetes Family Conflict Scale (DFCS) Parent Questionnaire Score at Months 3 and 6|"The DFCS Questionnaire has 19 questions, each question ranges in response values between 1 (Almost Never) and 3 (Almost Always). The derived total score (19 questions) ranges between 19 and 57, where higher score indicates worsened condition. This questionnaire was answered by Children/adolescents and Parents."|Baseline, Months 3 and 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. The number analysed is the participants who were evaluable for this outcome measure.|||score on a scale||Standard Deviation|Mean
2564461|NCT02609399|Primary|Mean Karnofsky Performance Scale Score During the 2016-2017 Influenza Season|"The Karnofsky Performance Scale is a tool for assessing subject functional impairment.~Subjects provided or received (from a healthcare provider such as a doctor or nurse) a daily rating from 0 (Dead) to 100 (Normal - no complaints, no evidence of disease) from enrollment through Day 14 of the 2016-2017 influenza season."|ED Enrollment Visit through Day 14 ( 2016-2017 influenza season)|All enrolled and randomized subjects with the exception of 1 inadvertent enrollment (subject found to be ineligible shortly after randomization)|||units on a scale||Standard Deviation|Mean
2564450|NCT02609633|Secondary|Change From Baseline in Diabetes-Related Distress Among Parents/Caregivers According to the PAID C&T Child Questionnaire Score at Month 3|"The PAID Questionnaire encompassed 26 items. Score for each question ranges from 1-2 = Not a Problem to 5-6 = Big Problem (Child version) or 1-2 = Not a Problem to 5-6 = Serious Problem (Teen or Parent versions). The derived total score (26 questions) ranges between 26 and 156, where higher score indicates worsened condition."|Baseline, Month 3|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4. Here, 'Number analysed' is the participants who were evaluable for this outcome measure.|||score on a scale||Standard Deviation|Mean
2564451|NCT02609633|Primary|Change From Baseline in Diabetes-Related Distress Among Parents/Caregivers According to the Problem Areas in Diabetes (PAID) Child and Teen (C&T) Parent Questionnaire Score at Month 6|"The PAID Questionnaire encompassed 26 items. Score for each question ranges from 1-2 = Not a Problem to 5-6 = Big Problem (Child version) or 1-2 = Not a Problem to 5-6 = Serious Problem (Teen or Parent versions). The derived total score (26 questions) ranges between 26 and 156, where higher score indicates worsened condition."|Baseline, Month 6|The FAS included all eligible families that have signed an informed consent and completed (with the acceptable level of missing questions to calculate a total score) all questions on the PAID Parent (YP or TP) Questionnaire at both baseline and Visit 4.|||score on a scale||Standard Deviation|Mean
2564452|NCT02609607|Secondary|Change From Baseline In Average Number of Fecal Incontinence Episodes at 4 Weeks|Subjects were asked to record each episode of fecal incontinence in their 'bowel diaries' during a preparatory phase of up to 4 weeks prior to study entry and for 4 weeks after intervention. We used this information to calculate the mean difference in the average number of fecal incontinence episodes / day.|Baseline, 4 weeks|These 'bowel diaries' were not required for entry into the trial. Thus, comparative data for bowel movement frequency was available for 3 of the 6 subjects randomized to placebo, and 2 of the 4 subjects randomized to receive Bisacodyl.|||incontinence episodes per day||Standard Deviation|Mean
2564453|NCT02609607|Secondary|Change From Baseline In Average Number of Daily Bowel Movements at 4 Weeks|Subjects were asked to record each bowel movement in their 'bowel diaries' during a preparatory phase of up to 4 weeks prior to study entry and for 4 weeks after intervention. We used this information to calculate the average difference in number of bowel movements / day before and after exposure to placebo or Bisacodyl. However, these 'bowel diaries' were not required for entry into the trial. Thus, comparative data for bowel movement frequency was available for 3 of the 6 subjects randomized to placebo, and 2 of the 4 subjects randomized to receive Bisacodyl.|Baseline, 4 weeks|These 'bowel diaries' were not required for entry into the trial. Thus, comparative data for bowel movement frequency was available for 3 of the 6 subjects randomized to placebo, and 2 of the 4 subjects randomized to receive Bisacodyl.|||bowel movements per day||Standard Deviation|Mean
2564454|NCT02609607|Secondary|Change From Baseline In Percent of Subjects With Normal Average Stool Form at 4 Weeks|The Bristol Stool Scale (BSS) is a validated measure of stool form, ranging from 1-7. Normal stool form is regarded as average scores of 3 to 4. Subjects were asked to assess the BSS in their 'bowel diaries' during a preparatory phase of up to 4 weeks prior to study entry and for 4 weeks after intervention, but these 'bowel diaries' were not required for entry into the trial.|Baseline, 4 weeks|Comparative data was available for only 3 of the 6 subjects randomized to placebo, and only 1 of the 4 subjects randomized to receive Bisacodyl.|||percentage of participants|||Number
2564455|NCT02609607|Secondary|Change From Baseline in SF-36 Scores at 4 Weeks|The RAND Health Survey (v.1) is a 36 item questionnaire that measures health in multiple domains. The measure is reported as scores on eight subscales: Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Energy/fatigue, Emotional well-being, Social functioning, Pain, and General health. Scores on each subscale range from 0 and 100, with higher scores indicative of better health function in the domain.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
2564456|NCT02609607|Secondary|Change From Baseline in PAC-QOL Scores at 4 Weeks|The Patient Assessment of Constipation Quality of Life (PAC-QOL) Questionnaire is a validated measure of the quality of life impact of constipation. The questionnaire is reported a total score, reported as the average item scores and ranging from 0 to 4, where higher scores represent poorer QOL.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
2564457|NCT02609607|Secondary|Change From Baseline in Fecal Incontinence Quality of Life (FIQL) Score at 4 Weeks|The Fecal Incontinence Quality of Life (FIQL) Scale measures of the impact of fecal incontinence on aspects of quality of life. There are 4 subscales: Lifestyle, Coping/Behavior, Depression/Self-Perception, and Embarrassment, each of which is calculated as an average score ranging from 1 to 5, with higher scores indicating a greater functional status of quality of life.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
2564458|NCT02609607|Secondary|Change From Baseline in Fecal Incontinence Severity Index (FISI) Score at 4 Weeks|The Fecal Incontinence Severity Index (FISI) is measures of fecal incontinence severity. The FISI score ranges from 0 to 61, with higher scores interpreted as worse fecal incontinence severity.|Baseline, 4 Weeks||||units on a scale||Standard Deviation|Mean
2564459|NCT02609607|Secondary|Change From Baseline in Mean PAC-SYM Subscale Scores at 4 Weeks|The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) is a validated measure of constipation severity. The questionnaire has a total score and three subscales: Abdominal Symptoms, Rectal Symptoms, and Stool Form. The mean total score and each of the scale subscores are reported in a range of 0-4, with higher scores meaning worse outcomes. A difference (number) of 0.75 in the mean PAC-SYM total and each of the subscale scores is regarded as a clinically significant change.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
2564460|NCT02609607|Primary|Number of Participants With 30% Improvement From Baseline in Bowel Symptoms at 4 Weeks|"All subjects were asked the following question at study entry ('baseline') and the end of 4 weeks of intervention: Using a scale of 1 to 10 (1 being no problem and 10 being maximally impactful symptoms), how would you rate the severity of your bowel symptoms over the past 2 weeks?~The range of reported values was 2-9. We took a response to be a 30% decrease (i.e. improvement) in the subjective symptom score between the baseline and 4 week assessment."|Baseline, 4 weeks||||Participants|||Count of Participants
2564513|NCT02608177|Secondary|Glycemic Variability|SD of glucose readings|last 6 days of each 28-day treatment period||||mg/dL||Standard Deviation|Mean
2564462|NCT02609399|Primary|Mean Karnofsky Performance Scale Score During the 2015-2016 Influenza Season|"The Karnofsky Performance Scale is a tool for assessing subject functional impairment.~Subjects provided or received (from a healthcare provider such as a doctor or nurse) a daily rating from 0 (Dead) to 100 (Normal - no complaints, no evidence of disease) from enrollment through Day 14 of the 2015-2016 influenza season."|ED Enrollment Visit through Day 14 ( 2015-2016 influenza season)|All subjects enrolled and randomized.|||units on a scale||Standard Deviation|Mean
2564463|NCT02609399|Primary|Mean Symptom Severity Score During the 2016-2017 Influenza Season for Symptom Domains as Assessed Using the FLU-PRO™ Questionnaire|"Symptom evaluation during the 2016-2017 influenza season as recorded through FLU-PRO™: a daily diary developed to assess occurrence and severity of influenza symptoms.~Item responses:~Not at all~A little bit~Somewhat~Quite a bit~Very much"|ED Enrollment Visit through Day 14 ( 2016-2017 influenza season)|All enrolled and randomized subjects with the exception of 1 inadvertent enrollment (subject found to be ineligible shortly after randomization)|||units on a scale||Standard Deviation|Mean
2564464|NCT02609399|Primary|Mean Symptom Severity Score During the 2015-2016 Influenza Season for Symptom Domains as Assessed Using the Influenza-Patient Reported Outcome (FLU-PRO™) Questionnaire|"Symptom evaluation during the 2015-2016 influenza season as recorded through FLU-PRO™: a daily diary developed to assess occurrence and severity of influenza symptoms.~Item responses:~Not at all~A little bit~Somewhat~Quite a bit~Very much"|ED Enrollment Visit through Day 14 ( 2015-2016 influenza season)|All subjects enrolled and randomized.|||units on a scale||Standard Deviation|Mean
2564465|NCT02609308|Secondary|Foot and Ankle Disability Index (FADI)|The Foot and Ankle Disability Index (FADI) assesses activities such as standing, walking on flat or uneven surfaces, walking on inclines, and the length of time of walking without difficulty. It also includes a section for sports activities and ankle or foot pain (or both). The highest score is 136 points, indicating the best clinical situation, free of pain and limitations, while the lowest score is 0.|Sixth month||||units on a scale||Standard Deviation|Mean
2564466|NCT02609308|Secondary|Visual Analogue Scale|Evaluate the pain in a scale of 0 to 10, when 0 is no pain, and 10 is the worst pain|Sixth month||||cm||Standard Deviation|Mean
2564467|NCT02609308|Primary|American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale (AOFAS)|Scale that evaluates pain, function and alignment of foot. The best score is 100 points, and the worst score are 0 points.|Sixth month||||units on a scale||Standard Deviation|Mean
2564468|NCT02609204|Primary|Flash Electroretinogram (FERG) Module Using Diopsys NOVA Latency|Clinical data from participants with a normal eye examination to establish expected normal values of Flash Electroretinogram (FERG) photopic negative response (PhNR) latency in milliseconds.|2 hours||||milliseconds||Standard Deviation|Mean
2564469|NCT02609204|Primary|Flash Electroretinogram (FERG) Module Using Diopsys NOVA (Neuro Optic Vision Assessment) Amplitude|Clinical data from participants with a normal eye examination to establish expected normal values of Flash Electroretinogram (FERG) photopic negative response (PhNR) amplitude in micro volts.|2 hours||||micro volts||Standard Deviation|Mean
2564470|NCT02609178|Primary|△DT Value|"Disocclusion time (DT) is defined as the time from maximum intercuspation to complete disocclusion during lateral movement. DT related tooth contacts with muscle activity. Abnormities in DT would result in change of muscle activity, thus facilitate the occurrence of temporomandibular joint disorders.~In the study, the DT value of each crown would be assessed before try-in (baseline) and immediately after try-in using T-scan (FGP, AVR, CON). Try-in procedure would be finished by the same clinician.~△DT was calculated for minimizing individual difference among participants. The equation for △DT was: △DT(FGP/ AVR/ CON)= DT (FGP/ AVR/ CON)-DT(baseline)"|2 weeks(plus or minus 7 days) after tooth preparation|Including participants who tried in all of the three differently designed artificial crowns.|||seconds||Standard Deviation|Mean
2564471|NCT02609178|Secondary|Likert's Scale|"The questionaire was designed to evaluate participants' feeling towards the occlusal interference. It would be given to the subject after immediately try-in the crowns. In the questionaire:~Score 0 = No interference (feel comfortable while biting on the artificial crown) Score 1 = Moderate interference(could feel the artificial crown is higher when biting on the artificial crown, but when firmly clenched, the upper teeth could bite on the lower ones) Score 2 = High interference(the artificial teeth is higher that the upper teeth couldn't bite on all the lower teeth when firmly clenched)"|2 weeks(plus or minus 7 days) after tooth preparation|Including participants who tried in all of the three differently designed artificial crowns.|||participants|||Number
2564472|NCT02609178|Secondary|Occlusal Adjusting Time for Crowns|Try-in procedure would be finished by the same clinician. The occlusal adjusting time would be counted using a timer and recorded.|2 weeks(plus or minus 7 days) after tooth preparation|Including participants who tried in all of the three differently designed artificial crowns.|||minutes||Standard Deviation|Mean
2564473|NCT02609178|Primary|△OT Value|"Occlusion time (OT) is defined as the time from the first contact of occluding teeth to maximum intercuspation. OT is directly related with patients' occlusal contact pattern; and some have considered it as a capable description of occlusion.~In the study, the OT value of each crown would be assessed before try-in (baseline) and immediately after try-in using T-scan (FGP, AVR, CON). Try-in procedure would be finished by the same clinician.~△OT was calculated for minimizing individual difference among participants. The equation for △OT was:△OT(FGP/ AVR/ CON)= OT (FGP/ AVR/ CON)-OT(baseline)"|2 weeks(plus or minus 7 days) after tooth preparation|Including participants who tried in all of the three differently designed artificial crowns.|||seconds||Standard Deviation|Mean
2564474|NCT02609113|Secondary|Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks|Ultrasound to assess the anatomy of the median nerve|Baseline and 6 weeks||||percentage of Abnormal|||Number
2564475|NCT02609113|Secondary|Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks|Ultrasound to assess the anatomy of the median nerve|Baseline and 6 weeks||||mm^2||Standard Deviation|Median
2564476|NCT02609113|Secondary|Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks|Ultrasound to assess the anatomy of the median nerve|Baseline and 6 weeks|The Median Nerve Echogenicity (% hypoechoic) was the same at 89%.|||percentage of hypoechoic|||Number
2564514|NCT02608177|Primary|Glucose Time in Range|Time with glucose 70-140 mg/dL|last 6 days of each 28-day treatment period||||minutes per day||Standard Deviation|Mean
2564477|NCT02609113|Primary|Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks|Patient reported outcome measure of symptom severity and functional status. Is made of the Symptom severity scale (11 items) score 1 to 5 where lower numbers denotes better outcomes; and the Functional status scale (8 items) score 1 to 5 where lower numbers denotes better outcomes. Total score 1- 95 where lower numbers denotes better outcomes.|Baseline and 6 weeks||||units on a scale||Standard Deviation|Median
2564478|NCT02609100|Secondary|Procedure Related Adverse Events|Adverse events related to the video capsule endoscopy and colonoscopy will be recorded|Up to 60 days||||Adverse Events|||Number
2564479|NCT02609100|Secondary|Duration of Hospital Stay|The duration of hospital stay will be recorded in number of days|Up to 60 days||||Days||Full Range|Mean
2564480|NCT02609100|Secondary|Number of Diagnostic Studies Performed for Evaluation of Gastrointestinal Bleeding|Includes repeat endoscopies or imaging|Up to 60 days||||Participants|||Count of Participants
2564481|NCT02609100|Secondary|Number of Blood Units Transfused|Number of blood units transfused measured in units of packed red blood cells|Up to 60 days||||Units of blood||Full Range|Mean
2564482|NCT02609100|Secondary|Therapeutic Yield of Colonoscopy|Therapeutic yield of colonoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention.|Up to 7 days||||Participants|||Count of Participants
2564483|NCT02609100|Secondary|Therapeutic Yield of Video Capsule Endoscopy|Therapeutic yield of video capsule endoscopy is defined as the proportion of endoscopies leading to a therapeutic intervention.|Up to 7 days||||Participants|||Count of Participants
2564484|NCT02609100|Primary|Number of Participants With Clinically Significant Findings Defined as Lesions Considered to Have a High Potential for Bleeding to Participants With no Significant Findings From Colonoscopy|Colonoscopy identifies clinically significant lesions defined as lesions considered to have high potential for bleeding, such as a large ulceration, tumor or typical angiomata|Up to one hour||||Participants|||Count of Participants
2564485|NCT02609100|Primary|Number of Participants With Clinically Significant Findings Defined as Lesions Considered to Have a High Potential for Bleeding to Participants With no Significant Findings From Video Capsule Endoscopy|Video Capsule Endoscopy identifies clinically significant lesions defined as lesions considered to have high potential for bleeding, such as a large ulceration, tumor or typical angiomata|Up to twenty four hours||||Participants|||Count of Participants
2564486|NCT02608905|Secondary|Arterial Flow Mediated Dilatation (%)|The percentage change in arterial flow mediated dilation (%) from baseline as measured by ultrasound in patients with type 2 diabetes.|12 weeks|The data was not collected||||||
2564487|NCT02608905|Primary|Monocyte Inflammatory Protein Nuclear Factor Kappa-B (NFkappaB) (%)|The percentage change in monocyte inflammatory proteins NFkappaB (%) from baseline in patients with type 2 diabetes.|12 weeks|The data was not collected.||||||
2564488|NCT02608892|Secondary|Proportion of Parents Who Perceive the Duration of the Video as Acceptable|Parents who viewed the intervention video will answer one survey question about their perception of whether the 5-minute video was of appropriate duration (too long/too short/just right)|Within 24 hours after viewing video intervention|All 51 participants in the intervention group provided data for this outcome measure.|||Participants|||Count of Participants
2564489|NCT02608892|Secondary|Proportion of Parents Who Intend to Recommend the Video to Other Parents|Parents who viewed the intervention video will be asked one survey question about if they intend to recommend the video to other parents (yes/no)|Within 24 hours after viewing video intervention|All 51 participants in the intervention group provided data for this outcome measure.|||Participants|||Count of Participants
2564490|NCT02608892|Secondary|The Proportion of Parents Who Intend to Use or Advocate for at Least One of the Pain Management Strategies During Future Procedures|Parents who viewed the intervention video will be asked one survey question about if they intend to use or advocate for breastfeeding, skin to skin care and/or sucrose during future procedures (yes/no)|Within 24 hours after viewing video intervention|All 51 participants in the intervention group provided data for this outcome measure.|||Participants|||Count of Participants
2564491|NCT02608892|Primary|Pain Management Used During Newborn Screening Blood Test|Use of any pain management: breastfeeding or skin to skin care or sucrose|Within 48 hours of viewing video intervention|One participant was lost to follow-up in the intervention group.|||Participants|||Count of Participants
2564492|NCT02608684|Secondary|Frequency and Intensity of Adverse Events (CTCAE v.4), Deemed at Least Possibly Related to Study Participation|As measured at each visit, during safety follow up (30 days after discontinuation of treatment) and during follow up (every nine weeks after discontinuation). Adverse events graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4, with events graded from 1 to 5, where a higher grade reflects greater symptom severity.|Up to 2 years||||Participants|||Count of Participants
2564493|NCT02608684|Secondary|Overall Survival (OS)|Calculated in months from the start of treatment to the date of death from any cause|Up to 2 years||||months||95% Confidence Interval|Median
2564494|NCT02608684|Secondary|Duration of Response|Calculated in months as time from documentation of tumor response to disease progression|Up to 2 years|Among subjects who had a partial or complete response to treatment|||months||Full Range|Median
2564495|NCT02608684|Secondary|Time to Progression|Calculated in months from the start of treatment to disease progression as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Progressive Disease (PD), At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest sum on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.|Up to 2 years||||months||95% Confidence Interval|Median
2564515|NCT02608099|Other Pre-specified|Number of Patients With Cardiovascular Death|Cardiovascular death is included in this measurement.|Randomization to 1 month post catheter ablation||||Participants|||Count of Participants
2564516|NCT02608099|Other Pre-specified|Number of Patients With Death|Death is included in this measurement.|Randomization to 1 month post catheter ablation||||Participants|||Count of Participants
2564517|NCT02608099|Other Pre-specified|Number of Patients With Cardiovascular Death|Cardiovascular death is included in this measurement.|Enrollment to 1 month post catheter ablation||||Participants|||Count of Participants
2564496|NCT02608684|Secondary|Progression-free Survival (PFS) at 6 Months and at 12 Months|Percentage of patients who have not progressed at 6 and 12 months with progression-free survival calculated from the start of treatment to the date of progression or death from any cause. Progression is measured by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Progressive Disease (PD), At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest sum on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.|6 months and 12 months||||percentage of participants||95% Confidence Interval|Number
2564497|NCT02608684|Secondary|Overall Response Rate by iRECIST|Per Immune Response Evaluation Criteria In Solid Tumors Criteria (iRECIST) for target lesions and assessed by CT or MRI, where the threshold is reset if RECIST 1.1 progression is followed at the next assessment by tumor shrinkage: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 2 years||||Participants|||Count of Participants
2564498|NCT02608684|Primary|Overall Response Rate (ORR)|Defined as complete or partial response per RECIST 1.1 criteria with assessment every 6 weeks during first 6 cycles of therapy and every 9 weeks thereafter. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 2 years||||Participants|||Count of Participants
2564499|NCT02608489|Secondary|Number of Participants Who Stop Using the Eye Drops Due to Drug-related Discomfort|Drug-related discomfort is defined as having started after eye drop instillation and lasting several minutes, occurring every time during instillation at any time up to 12 weeks into the follow-up period. Patients that had any adverse events or wanted to stop using the eye drops were excluded from the study, but these patients were included in the safety evaluation.|12 weeks|Overall, 1 of 31 patients (3.22%), a 64-year-old man who underwent bilateral sequential same-day cataract surgery, stopped using the study eye drops owing to severe irritation in the D group.|||participants|||Number
2564500|NCT02608489|Secondary|Grades of Anterior Chamber Cells.|"Anterior chamber inflammation was examined with a slit-lamp clinically, and divided into six grades using the Standardization of Uveitis Nomenclature (SUN) working group grading scheme.~grade 0 : <1 cell in field, grade 0.5 : 1-5 cells in field, grade 1 : 6-15 cells in field, grade 2 : 16-25 cells in field grade 3 : 26-50 cells in field, grade 4 : >50 cells in field Field size is a 1 mm X 1 mm slit beam"|12 weeks||||grade|Participants|Standard Deviation|Mean
2564501|NCT02608489|Primary|Lissamine Green (LG) Conjunctival Staining That is Related to Dry Eye Severity|"Ocular surface damage was assessed by the National Eye Institute (NEI) workshop grading system, and conjunctival LG staining were evaluated. Instillation of 1% lissamine green in both eyes. After 1 or 2 full blinks, the intensity of staining of both medial and lateral bulbar conjunctiva was cored. According to the National Eye Institute (NEI) workshop grading system, the conjunctiva was divided into six sections. The minimum staining score was 0 and the maximum staining score was 18 points (up to 3 points for each section).~0 : best score (no conjunctival damage) 18 : worst score (severe conjunctival damages)"|12 weeks||||Scores on a scale|Participants|Standard Deviation|Mean
2564502|NCT02608489|Primary|Corneal Fluorescein Staining That is Related to Dry Eye Severity.|"Ocular surface damage was assessed by the National Eye Institute (NEI) workshop grading system, and corneal fluorescein staining was evaluated. Instillation of fluorescein in both eyes. After 1 or 2 full blinks, the intensity of staining of both cornea was scored. According to the National Eye Institute (NEI) workshop grading system, the cornea was divided into five sections. The minimum staining score was 0 and the maximum staining score was 15 points (up to 3 points for each section).~0 : best score (no corneal damage) 15 : worst score (severe corneal damages)"|12 weeks||||scores|Participants|Standard Deviation|Mean
2564503|NCT02608489|Primary|Tear Break-up Time (TBUT) That is Related to Dry Eye Severity.|TBUT was assessed by instillation of a drop of 2% sterile fluorescein into the conjunctival sac and recording the interval between the last complete blink and the first appearance of a dry spot or disruption of the tear film.|12 weeks||||seconds|Participants|Standard Deviation|Mean
2564504|NCT02608489|Primary|Changes in HOAs After Blinking That is Related to Dry Eye Severity.|Corneal HOAs and serial measurement of ocular total HOAs were evaluated using a KR-1W wavefront analyzer (Topcon Medical System, Inc., Tokyo, Japan). Serial measurement of total ocular HOAs was measured every second for 10 s after complete blinking in continuous measurement mode. The difference between the fifth and first HOA was used to evaluate the tear film instability.|12 weeks||||microns|Participants|Standard Deviation|Mean
2564505|NCT02608489|Primary|Schirmer I Test Without Anesthesia That is Related to Dry Eye Severity.|Schirmer paper strips were placed into the temporal one third of the lower conjunctival sac for 5 min and the wetness on the strips was measured.|12 weeks||||mm|Participants|Standard Deviation|Mean
2564506|NCT02608489|Primary|an Ocular Surface Disease Index (OSDI) Questionnaire That is Related to Dry Eye Severity.|The OSDI questionnaire consists of 12 questions that evaluate subjective symptoms related to dry eye and vision The score ranges were between 0 and 100 scores and the higher scores represent a worse outcome.|12 weeks||||scores on a scale|Participants|Standard Deviation|Mean
2564507|NCT02608177|Secondary|Biomarkers of Albuminuria|Measured by albumin-creatinine ratio|last 6 days of each 28-day treatment period|Labs not run due to small sample size.||||||
2564508|NCT02608177|Secondary|Biomarkers of Oxidative Stress|Measured by urine F2-isoprostanes|last 6 days of each 28-day treatment period|Labs not run due to small sample size.||||||
2564509|NCT02608177|Secondary|Biomarkers of Oxidative Stress|Measured by plasma F2-isoprostanes|last 6 days of each 28-day treatment period|Labs not run due to small sample size.||||||
2564510|NCT02608177|Secondary|Biomarkers of Systemic Inflammation|Measured by plasma interleukin-6|last 6 days of each 28-day treatment period|Labs not run due to small sample size.||||||
2564511|NCT02608177|Secondary|Biomarkers of Systemic Inflammation|Measured by plasma C-reactive protein (CRP)|last 6 days of each 28-day treatment period|Labs not run due to small sample size.||||||
2564512|NCT02608177|Secondary|Hypoglycemia|Glucose <70 mg/dL for at least 10 minutes|last 6 days of each 28-day treatment period||||events|||Number
2564521|NCT02608099|Other Pre-specified|Number of Patients With Composite of Major Bleeding and Thrombotic Events|"Thrombotic events are defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.~Major bleeding is defined as bleeding meeting BARC criteria type 3 or higher."|Enrollment to 1 month post catheter ablation||||Participants|||Count of Participants
2564522|NCT02608099|Other Pre-specified|Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events|"Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.~Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher."|Enrollment to 1 month post catheter ablation||||Participants|||Count of Participants
2564523|NCT02608099|Other Pre-specified|Number of Patients With Thrombotic Events|Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.|Enrollment to 1 month post catheter ablation||||Participants|||Count of Participants
2564524|NCT02608099|Other Pre-specified|Number of Patients With Major Bleeding|Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher.|Enrollment to 1 month post catheter ablation||||Participants|||Count of Participants
2564525|NCT02608099|Other Pre-specified|Number of Patients With Major Bleeding|Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher.|Randomization to 1 month post catheter ablation||||Participants|||Count of Participants
2564526|NCT02608099|Other Pre-specified|Number of Patients With Clinically-Significant Bleeding|Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.|Enrollment to 1 month post catheter ablation||||Participants|||Count of Participants
2564527|NCT02608099|Secondary|Number of Patients With Composite of Clinically Significant Bleeding and Thrombotic Events|"Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.~Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher."|Randomization to 1 month post catheter ablation||||Participants|||Count of Participants
2564528|NCT02608099|Secondary|Number of Patients With Composite of Major Bleeding and Thrombotic Events|Major bleeding was defined as bleeding meeting BARC criteria type 3 or higher. Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.|Randomization to 1 month post catheter ablation||||Participants|||Count of Participants
2564529|NCT02608099|Primary|Number of Patients With Thrombotic Events|Thrombotic events were defined as a composite of non-hemorrhagic stroke and systemic thromboembolic events.|Randomization to 1 month post catheter ablation||||Participants|||Count of Participants
2564530|NCT02608099|Primary|Number of Patients With Clinically-Significant Bleeding|Clinically significant bleeding was defined as bleeding meeting Bleeding Academic Research Consortium (BARC) criteria type 2 or higher.|Randomization to 1 month post catheter ablation||||Participants|||Count of Participants
2564531|NCT02607956|Secondary|Change From Baseline in CD4+ Cell Count at Week 96 Open-Label||Baseline; open-label Week 96|||||||
2564532|NCT02607956|Secondary|Change From Baseline in CD4+ Cell Count at Week 48 Open-Label||Baseline; open-label Week 48|||||||
2564533|NCT02607956|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded and Missing = Failure Algorithm||Baseline; open-label Week 96|||||||
2564534|NCT02607956|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded and Missing = Failure Algorithm||Baseline; open-label Week 48|||||||
2564535|NCT02607956|Secondary|Change From Baseline in CD4+ Cell Count at Week 144||Baseline; Week 144|Participants in the Full Analysis Set with available data were analyzed.|||cells/μL||Standard Deviation|Mean
2564536|NCT02607956|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with available data were analyzed.|||cells/μL||Standard Deviation|Mean
2564537|NCT02607956|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||cells/μL||Standard Deviation|Mean
2564538|NCT02607956|Secondary|Change From Baseline in log10 HIV-1 RNA at Week 144||Baseline; Week 144|Participants in the Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2564539|NCT02607956|Secondary|Change From Baseline in log10 HIV-1 RNA at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2564540|NCT02607956|Secondary|Change From Baseline in log10 HIV-1 RNA at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2564541|NCT02607956|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 144|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2564542|NCT02607956|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2564543|NCT02607956|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2566437|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Aspartate Aminotransferase (U/L)||Baseline, Week 24|Participants with measurements at given time point.|||U/L||Standard Deviation|Mean
2564544|NCT02607956|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 144|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2564545|NCT02607956|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2564546|NCT02607956|Primary|Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug.|||percentage of participants|||Number
2564547|NCT02607930|Secondary|Change From Baseline in CD4+ Cell Count at Week 96 Open-Label||Baseline; open-label Week 96|||||||
2564548|NCT02607930|Secondary|Change From Baseline in CD4+ Cell Count at Week 48 Open-Label||Baseline; open-label Week 48|||||||
2564549|NCT02607930|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded and Missing = Failure Algorithm||Baseline; open-label Week 96|||||||
2564550|NCT02607930|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded and Missing = Failure Algorithm||Baseline; open-label Week 48|||||||
2564551|NCT02607930|Secondary|Percentage Change From Baseline in Spine BMD at Week 144||Baseline; Week 144|Participants in the Spine DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2564552|NCT02607930|Secondary|Percentage Change From Baseline in Spine BMD at Week 96||Baseline; Week 96|Participants in the Spine DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2564553|NCT02607930|Secondary|Percentage Change From Baseline in Spine BMD at Week 48||Baseline; Week 48|Participants in the Spine DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2564554|NCT02607930|Secondary|Percentage Change From Baseline in Hip BMD at Week 144||Baseline; Week 144|Participants in the Hip DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2564555|NCT02607930|Secondary|Percentage Change From Baseline in Hip BMD at Week 96||Baseline; Week 96|Participants in the Hip DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2564556|NCT02607930|Secondary|Percentage Change From Baseline in Hip BMD at Week 48||Baseline; Week 48|Participants in the Hip DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2564557|NCT02607930|Secondary|Change From Baseline in CD4+ Cell Count at Week 144||Baseline; Week 144|Participants in the Full Analysis Set with available data were analyzed.|||cells/µL||Standard Deviation|Mean
2564558|NCT02607930|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with available data were analyzed.|||cells/µL||Standard Deviation|Mean
2564559|NCT02607930|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||cells/µL||Standard Deviation|Mean
2564560|NCT02607930|Secondary|Change From Baseline in log10 HIV-1 RNA at Week 144||Baseline; Week 144|Participants in the Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2564561|NCT02607930|Secondary|Change From Baseline in log10 HIV-1 RNA at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2564562|NCT02607930|Secondary|Change From Baseline in log10 HIV-1 RNA at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2564563|NCT02607930|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 144|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2564564|NCT02607930|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2564565|NCT02607930|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2564817|NCT02605187|Primary|Opioid Consumption in the 0-48 Hour Study Periods.|Opioid consumption was measured in milligram morphine equivalents in the 0-24 and 24-48 hour study periods.|0-24 and 24-48 hour postoperative periods|Participants who completed the protocol are included in the analysis.|||milligram morphine equivalents (MMEQ)||Inter-Quartile Range|Median
2564566|NCT02607930|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 144|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2564567|NCT02607930|Secondary|Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2564568|NCT02607930|Primary|Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug.|||percentage of participants|||Number
2564569|NCT02607865|Secondary|Change in CoEQ: Scores From the 4 Domains and the 19 Items|Change from baseline (week 0) in Control of Eating Questionnaire (CoEQ) was evaluated at weeks (wk) 26, 52 and 78. The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control' (items 9-12, 19), 'positive mood' (items 5-8), 'craving for savoury' (items 4, 16-18) and 'craving for sweet' (items 3, 13-15). The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the data from the in-trial observation period.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2564570|NCT02607865|Secondary|Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains|The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. The items of the IWQOL-Lite-CT pertain to physical functioning (physical, physical function and pain/discomfort) and psychosocial domains and all items employ a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2564571|NCT02607865|Secondary|Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS)|SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26, 52 and 78. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Score on a scale||Standard Deviation|Mean
2564572|NCT02607865|Secondary|Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses|This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Semaglutide plasma concentrations for participants in the pharmacokinetic (PK) subpopulation are presented. The PK subpopulation consisted of participants from sites in Germany, Japan and the United States receiving oral semaglutide (3 mg, 7 mg or 14 mg). Results are based on the data from the on-treatment observation period and follow-up period. The on-treatment observation period was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Weeks 0-83|Overall number of participants analysed = number of participants in the PK subpopulation. Number Analyzed = number of participants with available data in the PK subpopulation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2564573|NCT02607865|Secondary|Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes|Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 83 (78-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Weeks 0-83|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Participants|||Count of Participants
2564574|NCT02607865|Secondary|Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes|Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-83 (78-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Weeks 0-83|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product.|||Episodes|||Number
2564575|NCT02607865|Secondary|Anti-semaglutide Binding Antibody Levels|This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-83). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-83|Overall number of participants analysed = participants who were found positive for anti-semaglutide antibodies.|||%B/T||Standard Deviation|Mean
2564576|NCT02607865|Secondary|Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)|This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-83|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2564577|NCT02607865|Secondary|Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)|This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-83|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2564578|NCT02607865|Secondary|Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no)|This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-83|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2564579|NCT02607865|Secondary|Occurrence of Anti-semaglutide Binding Antibodies (Yes/no)|This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-83|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2564580|NCT02607865|Secondary|Change in Eye Examination Category|Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2), week 52 and week 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week -2, week 52, week 78|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2564581|NCT02607865|Secondary|Change in Physical Examination|Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2), weeks 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland.|Week -2, week 52, week 78|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2564600|NCT02607865|Secondary|Change in HDL Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of HDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2564582|NCT02607865|Secondary|Change in ECG Evaluation|Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26, 52 and 78. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2564583|NCT02607865|Secondary|Change in SBP and DBP|Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26, 52 and 78. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||mmHg||Standard Deviation|Mean
2564584|NCT02607865|Secondary|Change in Pulse Rate|Change from baseline (week 0) in pulse rate was evaluated at weeks 26, 52 and 78. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Beats/minute||Standard Deviation|Mean
2564585|NCT02607865|Secondary|Change in Lipase (Ratio to Baseline)|Change from baseline (week 0) in lipase (U/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2564586|NCT02607865|Secondary|Change in Amylase (Ratio to Baseline)|Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2564587|NCT02607865|Secondary|Number of TEAEs During Exposure to Trial Product|Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 83 (78-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Weeks 0-83|Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product.|||Events|||Number
2564588|NCT02607865|Secondary|Time to Rescue Medication|Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26, week 0 to week 52 and week 0 to week 78. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Weeks 0-78|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2564589|NCT02607865|Secondary|Time to Additional Anti-diabetic Medication|Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26, week 0 to week 52 and week 0 to week 78. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 78), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Weeks 0-78|Overall number of participants analyzed = FAS which comprised all randomised participants.|||Participants|||Count of Participants
2564590|NCT02607865|Secondary|Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no)|Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2564934|NCT02604199|Secondary|Pharmacokinetics of ARC-520: Maximum Observed Plasma Concentration (Cmax)||Through 48 hours post-dosing on Day 1 and Day 85|Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.||||||
2564591|NCT02607865|Secondary|Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no)|Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26, 52 and 78 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2564592|NCT02607865|Secondary|Participants Who Achieve Weight Loss ≥10% (Yes/no)|Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2564593|NCT02607865|Secondary|Participants Who Achieve Weight Loss ≥5% (Yes/no)|Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2564594|NCT02607865|Secondary|Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no)|Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2564595|NCT02607865|Secondary|Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)|Participants who achieved HbA1c <7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Participants|||Count of Participants
2564596|NCT02607865|Secondary|Change in SMPG - Mean Postprandial Increment Over All Meals|Change from baseline (week 0) in the average of the post-prandial increments over all meals was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2564597|NCT02607865|Secondary|Change in SMPG - Mean 7-point Profile|Change from baseline (week 0) in mean 7-point self-measured plasma glucose (SMPG) profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2564598|NCT02607865|Secondary|Change in Free Fatty Acids (Ratio to Baseline)|Change from baseline (week 0) in free fatty acids (FFA) (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Because of an issue with the handling of the blood samples for FFA, all FFA data were considered invalid for this trial; thus, no conclusion with regards to FFA levels can be made based on the data presented here.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of FFA||Geometric Coefficient of Variation|Geometric Mean
2564599|NCT02607865|Secondary|Change in Triglycerides (Ratio to Baseline)|Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of triglycerides||Geometric Coefficient of Variation|Geometric Mean
2564601|NCT02607865|Secondary|Change in VLDL Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in very-low-density lipoprotein (VLDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of VLDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2564602|NCT02607865|Secondary|Change in LDL Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of LDL cholesterol||Geometric Coefficient of Variation|Geometric Mean
2564603|NCT02607865|Secondary|Change in Total Cholesterol (Ratio to Baseline)|Change from baseline (week 0) in total cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Ratio of total cholesterol||Geometric Coefficient of Variation|Geometric Mean
2564604|NCT02607865|Secondary|Change in Waist Circumference|Change from baseline (week 0) in waist circumference was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||cm||Standard Deviation|Mean
2564605|NCT02607865|Secondary|Change in BMI|Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Kg/m^2||Standard Deviation|Mean
2564606|NCT02607865|Secondary|Change in FPG|Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||mmol/L||Standard Deviation|Mean
2564607|NCT02607865|Secondary|Change in Body Weight (%)|Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 26, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Percentage change||Standard Deviation|Mean
2564608|NCT02607865|Secondary|Change in Body Weight (kg): Weeks 52 and 78|Change from baseline (week 0) in body weight was evaluated at weeks 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Kg||Standard Deviation|Mean
2564609|NCT02607865|Secondary|Change in HbA1c: Weeks 52 and 78|Change from baseline (week 0) in HbA1c was evaluated at weeks 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product.|Week 0, week 52, week 78|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2564610|NCT02607865|Secondary|Change in Body Weight: Week 26|Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Week 0, week 26|Overall number of participants analyzed = FAS which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Kg||Standard Deviation|Mean
2564649|NCT02607306|Secondary|High Density Lipoprotein (HDL) Cholesterol as a Ratio to Baseline at 52 Weeks|High density lipoprotein (HDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.|After 52 weeks of treatment|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2564611|NCT02607865|Primary|Change in HbA1c: Week 26|Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Week 0, week 26|Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2564612|NCT02607800|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2564613|NCT02607800|Secondary|Change From Baseline in HCV RNA||Baseline; Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2564614|NCT02607800|Secondary|Percentage of Participants With HCV RNA < LLOQ On Treatment||Weeks 1, 2, 4, 8, and 12|Percentage of participants in Full Analysis Set with on-treatment data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2564615|NCT02607800|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2564616|NCT02607800|Primary|Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
2564617|NCT02607800|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: all randomized/enrolled participants who took at least 1 dose of the study drug|||percentage of participants||95% Confidence Interval|Number
2564618|NCT02607735|Secondary|Percentage of Participants With Virologic Failure (Deferred Treatment Substudy)|"Virologic failure is defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA LLOQ while on treatment), or~Rebound (confirmed 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA LLOQ at last on-treatment visit."|Up to Posttreatment Week 24 (Deferred Treatment Substudy)|Full Analysis Set in the Deferred Treatment Substudy|||percentage of participants|||Number
2564619|NCT02607735|Secondary|Change From Baseline in HCV RNA (Deferred Treatment Substudy)||Baseline; Weeks 1, 2, 4, 8, and 12 (Deferred Treatment Substudy)|Participants with available data in the Full Analysis Set of the Deferred Treatment Substudy were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2564620|NCT02607735|Secondary|Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)||Weeks 1, 2, 4, 8 and 12 (Deferred Treatment Substudy)|Full Analysis Set from the Deferred Treatment Sub study: all enrolled participants who took at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2564621|NCT02607735|Secondary|Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy)|SVR4, SVR12 and SVR24 was defined as HCV RNA < LLOQ at 4, 12 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy)|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2564622|NCT02607735|Secondary|Percentage of Participants With Virologic Failure (Primary Study)|"Virologic failure is defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA LLOQ while on treatment), or~Rebound (confirmed 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Participants in the Full Analysis Set in the SOF/VEL/VOX group were analyzed. This outcome measure was not assessed for participants in the Placebo group because they did not have a Posttreatment Week 24 visit.|||percentage of participants|||Number
2564623|NCT02607735|Secondary|Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study)|SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Participants in the Full Analysis Set in the SOF/VEL/VOX group were analyzed. This outcome measure was not assessed for participants in the Placebo group because they did not have a Posttreatment Week 24 visit.|||percentage of participants||95% Confidence Interval|Number
2564624|NCT02607735|Secondary|Change From Baseline in HCV RNA (Primary Study)||Baseline; Weeks 1, 2, 4, 8 and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2564625|NCT02607735|Secondary|Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study)||Weeks 1, 2, 4, 8 and 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2564626|NCT02607735|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) (Primary Study)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment, respectively.|Posttreatment Week 4|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2564627|NCT02607735|Primary|Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (Primary Study)||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
2564628|NCT02607735|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Participants in the Full Analysis Set (all randomized/enrolled participants who took at least 1 dose of study drug) in the SOF/VEL/VOX group were analyzed. This outcome measure was not assessed for participants in the Placebo group because they did not have a Posttreatment Week 12 visit.|||percentage of participants||95% Confidence Interval|Number
2564629|NCT02607618|Secondary|Number of Participants With Resolution or Near Resolution of Lesion at Test of Cure Visit|Resolution or Near Resolution of Lesion at Test of Cure (TOC) Visit.|7 to14 days after the end of treatment||||participants|||Number
2564630|NCT02607618|Primary|Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline|≥20% reduction in lesion size at 48 to 72 hours (Early Time Point [ETP]) compared to baseline in all randomized patients (ITT).|Baseline and 48 to 72 hours after first dose of study drug||||percentage of participants||95% Confidence Interval|Number
2564631|NCT02607306|Secondary|Plasma Concentrations of Liraglutide|Samples from the IDegLira and liraglutide arms were assayed for plasma concentrations of liraglutide using validated ELISA assays.|Weeks 2, 8, 16, 26, 44, 52|Full Analysis Set (FAS) included all randomised subjects (819 subjects). All subjects in FAS with at least one valid concentration value were included in the analysis. No imputations of missing concentration values were applied. Number Analyzed = subjects with available data. This endpoint is only applicable for subjects in IDegLira and Lira arm.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2564632|NCT02607306|Secondary|Serum Concentrations of Insulin Degludec|Samples from the IDegLira and IDeg arms were analysed for serum concentrations of insulin degludec using validated ELISA assays.|Weeks 2, 8, 16, 26, 44, 52|Full Analysis Set (FAS) included all randomised subjects (819 subjects). All subjects in FAS with at least one valid concentration value were included in the analysis. No imputations of missing concentration values were applied. Number Analyzed = subjects with available data. This endpoint is only applicable for subjects in IDegLira and IDeg arm.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2564633|NCT02607306|Secondary|Change in Clinical Evaluation: Pulse|Change in pulse after 52 weeks of treatment.|Week 0, week 52|"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation as treated."|||beats per minute||Standard Deviation|Mean
2564634|NCT02607306|Secondary|Change in Clinical Evaluation: Electrocardiogram (ECG)|The result of the ECG was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' ECG results at screening (week -2 to week 0) and week 52.|at screening (week -2 to week 0), at week 52|"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation as treated."|||Participants|||Count of Participants
2564635|NCT02607306|Secondary|Change in Clinical Evaluation: Fundoscopy or Fundus Photography|The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abnormal (Abn), Not Clinically significant (NCS); Abnormal, Clinically significant (CS). Reported results are number of subjects with 'normal'; 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at screening (week -2 to week 0) and week 52.|at screening (week -2 to week 0), at week 52|"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation as treated. Number Analyzed = subjects with available data."|||Participants|||Count of Participants
2564636|NCT02607306|Secondary|Anti-drug Antibodies: Number of Participants Positive or Negative for Anti-liraglutide Antibodies|Anti-liraglutide antibodies were measured at week 52. Number of participants positive or negative for anti-liraglutide antibodies at week 52 were reported.|at week 52|"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation as treated. Missing data were imputed using LOCF method.This endpoint is only applicable for subjects in IDegLira and Lira arm."|||Participants|||Count of Participants
2564637|NCT02607306|Secondary|Anti-drug Antibodies: Anti-insulin Degludec Antibodies|Insulin degludec (IDeg)-specific antibodies were measured at week 52, as %B/T (percentage of bound & precipitated radioactive drug/total added drug to the sample). A sample is measured in 2 different series. In series 1, the radioactive IDeg (tracer) and surplus unlabeled IDeg are added to the sample. In series 2, the tracer and surplus unlabeled human insulin are added to the sample. Series 1 represents unspecific background binding. Series 2 represents IDeg specific antibodies including unspecific background binding. The reported %B/T is calculated by subtracting the background %B/T in series 1 from the %B/T result in series 2. If the background result has higher values than the %B/T in series 2, the resulting value is negative %B/T. Here, a negative %B/T value means that the test samples do not have IDeg-specific antibodies. The reason for getting a negative value for %B/T is due to variation in the analytical background. Thus, the results presented are not a change from baseline.|at week 52|"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation as treated. Missing data were imputed using LOCF method. This endpoint is only applicable for subjects in IDegLira and IDeg arm."|||Percentage B/T||Standard Deviation|Mean
2564638|NCT02607306|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition|"Results represent total number of treatment emergent hypoglycaemic episodes that fall under ADA's definition of hypoglycaemia. ADA's definition of hypoglycaemia includes following categories:~Severe hypoglycaemia~Documented symptomatic hypoglycaemia~Asymptomatic hypoglycaemia~Probable symptomatic hypoglycaemia~Pseudo-hypoglycaemia. Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product."|0-52 weeks|"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation as treated."|||Episodes|||Number
2564639|NCT02607306|Secondary|Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes|"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. Nocturnal period: The period between 00:01 and 05:59 a.m. (both inclusive).~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.~Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration."|0-52 weeks|"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation as treated."|||Episodes|||Number
2564640|NCT02607306|Secondary|Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes|"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.~Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration."|0-52 weeks|"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation as treated."|||Episodes|||Number
2564641|NCT02607306|Secondary|Number of Treatment Emergent Adverse Events (TEAEs)|Treatment emergent adverse event is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.|0-52 weeks|"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation as treated."|||Events|||Number
2564642|NCT02607306|Secondary|Proinsulin as a Ratio to Baseline at 52 Weeks|Proinsulin after 52 weeks of treatment was represented as ratio to baseline (week 0) values.|After 52 weeks of treatment|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2564643|NCT02607306|Secondary|Fasting Glucagon as a Ratio to Baseline at 52 Weeks|Fasting glucagon after 52 weeks of treatment was represented as ratio to baseline (week 0) values.|After 52 weeks of treatment|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2564644|NCT02607306|Secondary|Fasting Human Insulin as a Ratio to Baseline at 52 Weeks|Fasting human insulin after 52 weeks of treatment was represented as ratio to baseline (week 0) values.|After 52 weeks of treatment|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2564645|NCT02607306|Secondary|Fasting C-peptide as a Ratio to Baseline at 52 Weeks|Fasting C-peptide after 52 weeks of treatment was represented as ratio to baseline (week 0) values.|After 52 weeks of treatment|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2564646|NCT02607306|Secondary|Free Fatty Acids as a Ratio to Baseline at 52 Weeks|Free fatty acids after 52 weeks of treatment was represented as ratio to baseline (week 0) values.|After 52 weeks of treatment|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2564647|NCT02607306|Secondary|Triglycerides as a Ratio to Baseline at 52 Weeks|Triglycerides after 52 weeks of treatment was represented as ratio to baseline (week 0) values.|After 52 weeks of treatment|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2564648|NCT02607306|Secondary|Very Low Density Lipoprotein (VLDL) Cholesterol as a Ratio to Baseline at 52 Weeks|Very low density lipoprotein (VLDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.|After 52 weeks of treatment|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2564650|NCT02607306|Secondary|Low Density Lipoprotein (LDL) Cholesterol as a Ratio to Baseline at 52 Weeks|Low density lipoprotein (LDL) cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.|After 52 weeks of treatment|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2564651|NCT02607306|Secondary|Total Cholesterol as a Ratio to Baseline at 52 Weeks|Total cholesterol after 52 weeks of treatment was represented as ratio to baseline (week 0) values.|After 52 weeks of treatment|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2564652|NCT02607306|Secondary|Change in SMBG 9-point Profile - Mean of Postprandial Increments (From Before Meal to 90 Min After for Breakfast, Lunch and Dinner)|Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. The mean increment over all meals was derived as the mean of all available meal increments.|Week 0, week 52|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.|||mmol/L||Standard Deviation|Mean
2564653|NCT02607306|Secondary|Change in SMBG 9-point Profile - Mean of the 9-point Profile|Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day. Mean of the 9-point profile was defined as the area under the profile (calculated using the trapezoidal method) divided by the measurement time.|Week 0, week 52|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.|||mmol/L||Standard Deviation|Mean
2564654|NCT02607306|Secondary|Self-Measured Blood Glucose (SMBG) 9-point Profile: 9-point Profile (Individual Points in the Profile)|Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, at bedtime, at 4:00 a.m. and before breakfast the following day.|After 52 weeks of the treatment|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.|||mmol/L||Standard Deviation|Mean
2564655|NCT02607306|Secondary|Change in Blood Pressure (Systolic and Diastolic)|Change from baseline in blood pressure (systolic and diastolic) after 52 weeks of treatment.|Week 0, Week 52|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||mmHg||Standard Deviation|Mean
2564656|NCT02607306|Secondary|Change in Waist Circumference|Change from baseline (week 0) in waist circumference after 52 weeks of treatment.|Week 0, Week 52|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Cm||Standard Deviation|Mean
2564657|NCT02607306|Secondary|Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment|"Number of subjects with HbA1c less than 6.5% with no weight gain, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia."|After 52 weeks of treatment|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.|||Participants|||Count of Participants
2564658|NCT02607306|Secondary|Responder (Yes/no): HbA1c Less Than 6.5% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.|"Number of subjects with HbA1c less than 6.5% after 52 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia."|After 52 weeks of treatment|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.|||Participants|||Count of Participants
2564659|NCT02607306|Secondary|Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero|Number of subjects with HbA1c less than 6.5% and without weight gain after 52 weeks of treatment.|After 52 weeks of treatment|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Participants|||Count of Participants
2564660|NCT02607306|Secondary|Responder (Yes/no): HbA1c Less Than 6.5%|Number of subjects with HbA1c less than 6.5% after 52 weeks of treatment.|After 52 weeks of treatment|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Participants|||Count of Participants
2564661|NCT02607306|Secondary|Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment|"Number of subjects with HbA1c less than 7.0% and without weight gain, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia."|After 52 weeks of treatment|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.|||Participants|||Count of Participants
2564662|NCT02607306|Secondary|Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.|"Number of subjects with HbA1c less than 7.0% after 52 weeks, who did not experience treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment.~Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia."|After 52 weeks of treatment|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.|||Participants|||Count of Participants
2564663|NCT02607306|Secondary|Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero|Number of subjects with HbA1c less than 7.0% and without weight gain after 52 weeks of treatment.|After 52 weeks of treatment|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Participants|||Count of Participants
2564664|NCT02607306|Secondary|Responder (Yes/no): HbA1c Less Than 7.0%|Number of subjects with HbA1c less than 7.0% after 52 weeks of treatment.|After 52 weeks of treatment|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Participants|||Count of Participants
2564665|NCT02607306|Secondary|Insulin Dose|Actual daily total insulin dose after 52 weeks of treatment.|After 52 weeks of treatment|"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation as treated. Missing data were imputed using LOCF method. This endpoint evaluation is only applicable for subjects in IDegLira and IDeg arm."|||Insulin Units/Day||Standard Deviation|Mean
2564666|NCT02607306|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline (week 0) in FPG after 52 weeks|Week 0, Week 52|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method. Number Analyzed = subjects with available data.|||mmol/L||Standard Deviation|Mean
2564667|NCT02607306|Secondary|Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Superiority of IDegLira vs IDeg|Change from baseline (week 0) in HbA1c after 52 weeks of treatment was measured. Statistical analysis was performed to test the hypothesis: superiority of IDegLira vs. IDeg.|Week 0, Week 52|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Percentage of HbA1c||Standard Deviation|Mean
2564686|NCT02606838|Secondary|Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 30 Gauge Lancets)|Untrained subjects with Diabetes operated the Styx Lancing Device with 30 Gauge lancets to obtain fingerstick capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all. The number of subjects with numeric BGMS results was determined.|1 hour||||participants|||Number
2564789|NCT02605642|Primary|Initial Dose of CT-P13 Infusion Administered to Participants|Initial dose of CT-P13 infusion (dose at the time of CT-P13 treatment initiation) was reported in this outcome measure.|At Day 1 of 2 year observation period|The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. Here “Overall number of participants analyzed” signifies participants who were evaluable for this outcome measure.|||milligram per kilogram||Full Range|Median
2564668|NCT02607306|Secondary|Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes|"Treatment emergent hypoglycaemic episode is defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last day on trial product.~Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value < 3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.~Severe hypoglycaemia according to the ADA definition: an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration."|Weeks 0-52|"Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (819 subjects). Subjects in the safety set contributed to the evaluation as treated."|||Episodes|||Number
2564669|NCT02607306|Secondary|Change From Baseline in Body Weight (kg)|Change from baseline (week 0) in body weight after 52 weeks of treatment.|Week 0, Week 52|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Kg||Standard Deviation|Mean
2564670|NCT02607306|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira|Change from baseline (week 0) in HbA1c after 52 weeks of treatment was measured. Statistical analyses were performed to test the hypotheses: non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Liraglutide (Lira).|Week 0, Week 52|Full Analysis Set (FAS) included all randomised subjects (819 subjects). The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. Missing data were imputed using last observation carried forward (LOCF) method.|||Percentage of HbA1c||Standard Deviation|Mean
2564671|NCT02607254|Secondary|Patient Global Impression of Change (PGIC);|patient assign a number between 1-7 to the level of improvement, 1 showing substantial improvement and 7 showing no improvement at all.|At 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase|Patients with idiopathic small fiber neuropathy|||score on PGIC scale||Standard Deviation|Mean
2564672|NCT02607254|Secondary|Sleep Quality as Assessed by Daily Sleep Interference Rating Scale (SIRS);|a scoring system describing sleep quality between 0-10 with 0 having no problem with sleep and 10 not being to sleep at all.|Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase|Patients with idiopathic small fiber neuropathy|||score on Sleep Interference Rating scale||Standard Deviation|Mean
2564673|NCT02607254|Secondary|Brief Pain Inventory (BPI sf);|Brief pain inventory is a scoring system for average pain intensity on scale of 0-10 with higher number meaning more pain.|Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase|Patients with idiopathic small fiber neuropathy.|||score in brief pain inventory scale||Standard Deviation|Mean
2564674|NCT02607254|Primary|Visual Analogue Score for Pain Intensity.|The primary outcome is change in visual analogue score for pain, with 0 being no pain at all and 10 being the most severe pain and a higher score meaning more pain, after 8 weeks of treatment phase and 4 weeks of randomized withdrawal phase.|Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase|Patient with idiopathic small fiber neuropathy.|||score on visual analogue score||Standard Deviation|Mean
2564675|NCT02606903|Secondary|Number of Subjects With Drug-related Adverse Events (AEs)|Number of subjects with drug-related Adverse Events (AEs). Any event with an onset after the administration of the trial medication up to a period of 70 days was defined as a treatment-emergent AE (TEAE). A treatment-related AE was defined as any TEAE assessed by the investigator as related to the trial medication.|From the first drug administration until 43 days observation period after drug administration and up to 70 days safety follow up period|Safety analysis set (SAF): The SAF consisted of all subjects in the enrolled set who received at least one dose of trial medication and subjects were classified according to treatment received.|||Number of Subjects|||Number
2564676|NCT02606903|Primary|Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)|Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) based on observed concentration at time of last measurable concentration. The rate and extent of absorption of BI 695501 by assessment of (AUC0-∞) following administration via AI or via PFS of a single dose of 40 mg BI 695501. During analysis, it was realized that the PK sample on Day 43 had originally been mistakenly associated with a 1032 h time point, rather than with 1008 h. However, PK parameters are calculated using actual values so this did not impact the analysis results.|PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h after drug administration.|Pharmacokinetic analysis set (PKS): The PKS consisted of all randomized subjects who received the single dose of trial medication, had at least one evaluable primary pharmacokinetic parameter, and were without important protocol deviations or violations thought to significantly affect the pharmacokinetics of BI 695501.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2564687|NCT02606838|Secondary|Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 28 Gauge Lancets)|Untrained subjects with Diabetes operated the Styx Lancing Device with 28 Gauge lancets to obtain AST palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all. The number of subjects with numeric BGMS results was determined.|1 hour|118 (119-1) Subject results were analyzed. One subject result was not evaluable because staff deviated from protocol by interfering with subject operation of the device.|||participants|||Number
2564813|NCT02605187|Secondary|Pruritus Score at 24 and 48 After Delivery|Score was rated on a scale from 0 to 10, where 0=no itching and 10=most itching.|24 and 48 hours following delivery|Participants who completed the protocol are included in the analysis.|||units on a scale||Standard Deviation|Mean
2564677|NCT02606903|Primary|Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 to 1032 Hours After Dose (AUC0-1032)|Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 to 1032 hours after dose (AUC0-1032). The rate and extent of absorption of BI 695501 by assessment of AUC0-1032 following administration via AI or via PFS of a single dose of 40 mg BI 695501. During analysis, it was realized that the PK sample on Day 43 had originally been mistakenly associated with a 1032 h time point, rather than with 1008 h. However, PK parameters are calculated using actual values so this did not impact the analysis results.|PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h after drug administration.|Pharmacokinetic analysis set (PKS): The PKS consisted of all randomized subjects who received the single dose of trial medication, had at least one evaluable primary pharmacokinetic parameter, and were without important protocol deviations or violations thought to significantly affect the pharmacokinetics of BI 695501.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2564678|NCT02606903|Primary|Maximum Measured Concentration of BI 695501 in Plasma (Cmax)|Maximum measured concentration of BI 695501 in plasma (Cmax). The rate and extent of absorption of BI 695501 by assessment of maximum plasma concentration following administration via AI or via PFS of a single dose of 40 mg BI 695501. During analysis, it was realized that the PK sample on Day 43 had originally been mistakenly associated with a 1032 h time point, rather than with 1008 h. However, PK parameters are calculated using actual values so this did not impact the analysis results.|PK plasma samples were taken at: 1 hour (h) before drug administration and 1h, 4h, 8h,12h, 24h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, 132h, 144h, 168h, 216h, 336h, 504h, 672h, 840h, 1008h after drug administration.|Pharmacokinetic analysis set (PKS): The PKS consisted of all randomized subjects who received the single dose of trial medication, had at least one evaluable primary pharmacokinetic parameter, and were without important protocol deviations or violations thought to significantly affect the pharmacokinetics of BI 695501.|||Micro-gram (µg) per milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
2564679|NCT02606877|Secondary|Treatment naïve, Area Under the Concentration-time Curve of Nintedanib in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)|AUC0-∞, area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.|Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.|Pharmacokinetic Analysis Set (PKS) - The PKS includes all patients in the treated set with at least one evaluable primary or secondary PK endpoint. (Observed cases)|||nanogram*hour/mililitre [ng*h/mL]||Standard Error|Geometric Mean
2564680|NCT02606877|Primary|Pirfenidone-treated, Maximum Measured Concentration of Pirfenidone in Plasma at Steady State (Cmax,ss)|Cmax,ss, maximum measured concentration of pirfenidone in plasma at steady state. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.|Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.|Pharmacokinetic Analysis Set (PKS) - The PKS includes all patients in the treated set with at least one evaluable primary or secondary PK endpoint. (Observed cases)|||nanogram/mililitre [ng/mL]||Standard Error|Geometric Mean
2564681|NCT02606877|Primary|Pirfenidone-treated, Area Under the Concentration-time Curve of Pirfenidone in Plasma Over a Dosing Interval at Steady State (AUCτ,ss)|AUCτ,ss, area under the concentration-time curve of pirfenidone in plasma over a dosing interval at steady state. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.|Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.|Pharmacokinetic Analysis Set (PKS) - The PKS includes all patients in the treated set with at least one evaluable primary or secondary PK endpoint. (Observed cases)|||nanogram*hour/mililitre [ng*h/mL]||Standard Error|Geometric Mean
2564682|NCT02606877|Primary|Treatment naïve, Maximum Measured Concentration of Nintedanib in Plasma After Single Dose Administration (Cmax).|Cmax, maximum measured concentration of nintedanib in plasma. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.|Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.|Pharmacokinetic Analysis Set (PKS) - The PKS includes all patients in the treated set with at least one evaluable primary or secondary PK endpoint. (Observed cases)|||nanogram/mililitre [ng/mL]||Standard Error|Geometric Mean
2564683|NCT02606877|Primary|Treatment naïve, Area Under the Concentration-time Curve of the Nintedanib in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz).|AUC0-tz , area under the concentration-time curve of nintedanib in plasma over the time interval from 0 to the last quantifiable concentration. Standard error mentioned in the Method of Dispersion is actually a Geometric Standard Error.|Blood samples were collected at pre-dose and at 0:30, 1:00, 2:00, 3:00, 4:00, 6:00, 8:00 and 10:00 hours post dose.|Pharmacokinetic Analysis Set (PKS) - The PKS includes all patients in the treated set with at least one evaluable primary or secondary PK endpoint. (Observed cases)|||nanogram*hour/mililitre [ng*h/mL]||Standard Error|Geometric Mean
2564684|NCT02606838|Secondary|Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding the Styx Lancing Device|Staff obtained responses from persons with Diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the Styx Lancing Device. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'. The percent of subjects who provided responses that were 'Strongly Agree' or 'Agree' or 'Neutral' about each statement was calculated.|1 hour||||percentage of participants|||Number
2564685|NCT02606838|Secondary|Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 30 Gauge Lancets)|Untrained subjects with Diabetes operated the Styx Lancing Device with 30 Gauge lancets to obtain AST palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all. The number of subjects with numeric BGMS results was determined.|1 hour|117 (119-2) Subject results were analyzed. Two subject results were not evaluable because staff deviated from protocol by interfering with subjects' operation of the device.|||participants|||Number
2564688|NCT02606838|Primary|Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 28 Gauge Lancets)|Untrained subjects with Diabetes operated the Styx Lancing Device with 28 Gauge lancets to obtain fingerstick capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all. The number of subjects with numeric BGMS results was determined.|1 hour||||participants|||Number
2564689|NCT02606734|Primary|Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure|The subject is exited from the study once they are discharged.|1 Day||||percent of contrast media saved||Standard Deviation|Mean
2564690|NCT02606643|Secondary|Vaginal Delivery Within 24 Hours|vaginal delivery within 24 hours-not all deliveries were within 24hours|24 hours|Twenty four hour Vaginal delivery between groups|||participants|||Number
2564691|NCT02606643|Secondary|Deliveries Via Cesarean Delivery|What number of deliveries in the tension and no tension groups were via Cesarean delivery|intraoperative||||participants|||Number
2564692|NCT02606643|Primary|Duration|Hours of labor|hours to delivery 0-26|an alpha level of .05, and a level of power of 80%. These parameters required a sample size of 63 patients per group|||hours||Full Range|Mean
2564693|NCT02606604|Secondary|Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54|The Multiple Sclerosis Quality of Life-54 is a self-report quality of life questionnaire. It measures health-related quality of life using both generic and disease-specific measures and was constructed by experts in the field. There is no overall score for this scale since it contains 12 subscales, two summary scores, and two single-item measures. The quality of life subscale was the chosen outcome measure reported below. The scores range from 0-100. Higher scores on the scale notes improved outcome.|8 weeks||||score on a scale||Standard Error|Mean
2564694|NCT02606604|Secondary|Overall Self-reported Quality of Life Using Multiple Sclerosis Quality of Life- 54|The Multiple Sclerosis Quality of Life-54 is a self-report quality of life questionnaire. It measures health-related quality of life using both generic and disease-specific measures and was constructed by experts in the field. There is no overall score for this scale since it contains 12 subscales, two summary scores, and two single-item measures. The quality of life subscale was the chosen outcome measure reported below. The scores range from 0-100. Higher scores on the scale notes improved outcome.|Baseline||||score on a scale||Standard Error|Mean
2564695|NCT02606604|Secondary|Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale|The Multiple Sclerosis Walking Scale is a 12-item self-report questionnaire that takes approximately 10 minutes to complete and reflects a persons' perception of the impact that multiple sclerosis has on walking ability during the past 2 weeks. Each of the items scored ranges from 1 to 5, in which higher scores indicate a greater impact of multiple sclerosis on their walking. Scores on the 12 items are summed. To transform to a 0‐100 scale, the minimum score of 12 is subtracted from the sum; the result is divided by 48 and then multiplied by 100. The lowest score is 0 and the highest score is 100. Higher scores mean a worse outcome.|8 weeks||||score on a scale||Standard Error|Mean
2564696|NCT02606604|Secondary|Self-reported Walking Using 12 Item Multiple Sclerosis Walking Scale|The Multiple Sclerosis Walking Scale is a 12-item self-report questionnaire that takes approximately 10 minutes to complete and reflects a persons' perception of the impact that multiple sclerosis has on walking ability during the past 2 weeks. Each of the items scored ranges from 1 to 5, in which higher scores indicate a greater impact of multiple sclerosis on their walking. Scores on the 12 items are summed. To transform to a 0‐100 scale, the minimum score of 12 is subtracted from the sum; the result is divided by 48 and then multiplied by 100. The lowest score is 0 and the highest score is 100. Higher scores mean a worse outcome.|Baseline||||score on a scale||Standard Error|Mean
2564697|NCT02606604|Secondary|Self-reported Fatigue Using Modified Fatigue Impact Scale|The Modified Fatigue Impact Scale is a 21 item self-report questionnaire that takes 5-10 minutes to complete. It uses a 5-point likert scale to rate the patient's perception of how Multiple Sclerosis related fatigue affects an individual's life on an everyday basis. It contains three subscales that include: cognitive, physical, and psychosocial dimensions. Scores on the subscales can be analyzed individually or as a summed score to give an overall fatigue score. Higher scores indicate a greater impact of fatigue. The minimum score is a 0 and the maximum score is 81.|8 weeks||||score on a scale||Standard Error|Mean
2564698|NCT02606604|Secondary|Self-reported Fatigue Using Modified Fatigue Impact Scale|The Modified Fatigue Impact Scale is a 21 item self-report questionnaire that takes 5-10 minutes to complete. It uses a 5-point likert scale to rate the patient's perception of how Multiple Sclerosis related fatigue affects an individual's life on an everyday basis. It contains three subscales that include: cognitive, physical, and psychosocial dimensions. Scores on the subscales can be analyzed individually or as a summed score to give an overall fatigue score. Higher scores indicate a greater impact of fatigue. The minimum score is a 0 and the maximum score is 81.|Baseline||||score on a scale||Standard Error|Mean
2564699|NCT02606604|Primary|Gait Velocity: Timed Walking|Gait velocity was reported in meters/second based on a 25 foot walk test called the Timed 25 foot Walk Test. Faster gait speeds are better outcomes.|12 weeks||||meters/second||Standard Error|Mean
2564700|NCT02606604|Primary|Gait Velocity: Timed Walking|Gait velocity was reported in meters/second based on a 25 foot walk test called the Timed 25 foot Walk Test. Faster gait speeds are better outcomes.|8 weeks||||meters/second||Standard Error|Mean
2564701|NCT02606604|Primary|Gait Velocity: Timed Walking|Gait velocity was reported in meters/second based on a 25 foot walk test called the Timed 25 foot Walk Test. Faster gait speeds are better outcomes.|4 weeks||||meters/second||Standard Error|Mean
2564702|NCT02606604|Primary|Gait Velocity: Timed Walking|Gait velocity was reported in meters/second based on a 25 foot walk test called the Timed 25 foot Walk Test. Faster gait speeds are better outcomes.|Baseline||||meters/second||Standard Error|Mean
2564743|NCT02605928|Primary|True Positive Detection of Synovial Fluid Marked in Case Report Form|Measurement device indicates with a sound and visual feedback when needle is in contact with synovial fluid. Physician verifies the location with ultrasound imaging, aspiration of synovial fluid and/or lack of resistance in glucocorticoid injection. Even if the device does not detect the synovial fluid, physician performs the injection when needed. Physician marks to the case report form whether the device provided detections during the puncture and were the detections true or false detections.|During intra-articular injection||||percentage of injected joints|Injected joints|95% Confidence Interval|Number
2564703|NCT02606500|Secondary|Real-time PCR Analysis of Genes That Were Proposed as Biomarkers of Oocyte Quality to Determine Effect of Corifollitropin Alpha on Oocyte Quality on Molecular Level|Expression of some genes that were proposed as biomarkers of oocyte quality was analysed in CC using real-time PCR. Relative expression values of genes were compared between mature oocytes derived from obese women and mature oocytes derived from normal weighing women.|12 months|Gene expression in cumulus cells surrounding mature oocytes was analyzed using quantitative polymerase chain reaction (qPCR). We analyzed 53 CC samples in the Study group and 56 CC samples in Control group.|||Arbitrary units (Relative expression)||Standard Deviation|Mean
2564704|NCT02606500|Primary|Biochemical Pregnancy Rate||1 year||||Biochemical pregnancies|||Number
2564705|NCT02606500|Primary|Number of Frozen Embryos||1 month||||Frozen embryos|||Number
2564706|NCT02606500|Primary|Number of Fertilized Oocytes||1 month||||Fertilized oocytes|||Number
2564707|NCT02606500|Primary|Number of Mature Oocytes|Number of mature oocytes obtained was compared between groups|1 month||||Mature oocytes|||Number
2564708|NCT02606500|Primary|Number of Oocytes Retrieved Per Patient|Number of oocytes obtained in the study group was compared to the number of oocytes obtained in the control group|1 month||||Oocytes||Standard Deviation|Mean
2564709|NCT02606279|Secondary|Change From Baseline in Frailty Status|Evaluated by measurements of grip strength, walking speed and questionnaires|3, 6, and 9 months post-enrollment|Participant did not complete visits, data not collected.||||||
2564710|NCT02606279|Primary|Change From Baseline in Quantity of AT1R and AT2R on Monocytes|Measured by using qPCR and western blot. (Units are arbitrary units)|3, 6, and 9 months post-enrollment|Participant did not complete visits, data not collected.||||||
2564711|NCT02606279|Primary|Change From Baseline in Grip Strength|Measured by dynamometer measurement of grip strength|3, 6, and 9 months post-enrollment|Participant did not complete visits, data not collected.||||||
2564712|NCT02606279|Primary|Change From Baseline in 400m Walk|Measured by time to finish 400 meter walk|3, 6, and 9 months post-enrollment|Participant did not complete visits, data not collected.||||||
2564713|NCT02606253|Other Pre-specified|Change in Patient Congestion Score|"Participants will score their congestion on a 10cm scale ranging from Best (10cm) to Worst (0cm). Change in score (units in centimeters) from baseline to 48 hours."|48 hours||||cm of dyspena analog scale||Inter-Quartile Range|Median
2564714|NCT02606253|Other Pre-specified|Change in Serum Chloride From Baseline|Change in serum chloride (mEq/L) from baseline to 48 hrs|48 hours||||mEq/L||Standard Deviation|Mean
2564715|NCT02606253|Other Pre-specified|Diuretic Efficiency|Diuretic Efficiency is calculated as 48hr urine output/ 48hr Furosemide equivalents in milligrams|48 hours||||UOP / 40mg IV furosemide||Standard Deviation|Mean
2564716|NCT02606253|Other Pre-specified|Number of Patients With Renal Replacement Therapy Utilization|Incidence of Renal replacement therapy utilization (hemodialysis, ultrafiltration) from enrollment to hospital discharge, an average of 5 days|enrollment to hospital discharge an average of 5 days||||Participants|||Count of Participants
2564717|NCT02606253|Other Pre-specified|Number of Patients With New Inotrope Utilization|Incidence of new initiation of dopamine, dobutamine, or milrinone from enrollment to end of study at 48 hours|48 hours||||Participants|||Count of Participants
2564718|NCT02606253|Other Pre-specified|Number of Patients With In-hospital Mortality|Incidence of death from study enrollment to hospital discharge, an average of 5 days|Enrollment to hospital discharge an average of 5 days||||Participants|||Count of Participants
2564719|NCT02606253|Secondary|Mean Change in Serum Sodium|Mean change in serum sodium (mEq/L) from enrollment to end of study at 48 hours|48 hours||||mEq/L||Standard Deviation|Mean
2564720|NCT02606253|Secondary|Change in eGFR From Baseline to 48 Hours|Change in estimated glomerular filtration rate (ml/min/m2) from baseline to 48 hours|48 hours||||ml/min/m2||Standard Deviation|Mean
2564721|NCT02606253|Secondary|Number of Patients With Symptomatic Hypotension|SBP < 85 mmHg plus medical intervention for symptomatic hypotension|48 hours||||Participants|||Count of Participants
2564722|NCT02606253|Secondary|Number of Patients With Cardiac Arrhythmias|Incidence of new atrial or ventricular arrhythmias from enrollment to end of study at 48 hours|48 hours||||Participants|||Count of Participants
2564723|NCT02606253|Secondary|Number of Patients With Escalation of Loop Diuretic Therapy|Provider escalation of loop diuretic dosage at 24 hours for urine output less than 3 L at 24 hours|24 hours||||Participants|||Count of Participants
2564724|NCT02606253|Secondary|Number of Patients With Hypokalemia|Incidence of hypokalemia (serum potassium less than 3.5mEq/L ) from enrollment to end of study|48 hours||||Participants|||Count of Participants
2564725|NCT02606253|Secondary|Potassium Supplementation|Cumulative dose of potassium supplementation (mEq) administered from enrollment to end of study at 48 hours|48 hours||||mEq||Standard Deviation|Mean
2564726|NCT02606253|Secondary|Mean Change in Serum Potassium|Mean change in serum potassium (mEq/L) from enrollment to end of study at 48 hours|48 hours||||mEq/L||Standard Deviation|Mean
2564727|NCT02606253|Secondary|Mean Change in Glomerular Filtration Rate at Discharge|Mean change in glomerular filtration rate from enrollment to end of study at hospital discharge, an average of 5 days|hospital discharge an average of 5 days||||ml/min/m2||Standard Deviation|Mean
2564728|NCT02606253|Secondary|Mean Change in Serum Creatinine|Mean change in serum creatinine (mg/dl) from enrollment to end of study at 48 hours|48 hours||||mg/dl||Standard Deviation|Mean
2564729|NCT02606253|Secondary|Net Urine Output|Net urine output from enrollment to the end of study at 48 hours measured in liters|48 hours|Intention to treat|||liters||Inter-Quartile Range|Median
2564730|NCT02606253|Primary|Weight Change Over 48 Hours|The primary outcome will be 48-hour standing scale weight change (kg) from enrollment among the metolazone, intravenous chlorothiazide, and tolvaptan arms, using metolazone group as the comparator group for all other groups.|48 hours|Intention to treat analysis|||kg||Standard Deviation|Mean
2564772|NCT02605824|Primary|Change in Post-bronchodilator FEV1 (L)|This is a measure of forced expiratory volume measured in one second, following the administration of 4 puffs of albuterol. This outcome will compare the change in post-bronchodilator FEV1 (L) both before and after treatment.|7 days|Only one subject was enrolled into the intervention, and after taking the first dose of NAC, they experienced excessive bronchospasm thus making them ineligible to continue and complete the study.||||||
2564731|NCT02605993|Secondary|Change In Clinical Manifestations Of PNH From Baseline To Day 253 And Day 281|Clinical manifestations were assessed from Baseline to Day 253 for Cohorts 1 to 4 and from Baseline to Day 281 for Cohort 4 only. Clinical manifestations were defined as fatigue, abdominal pain, dyspnea, dysphagia, chest pain, and erectile dysfunction (male participants only). Improvement was defined as present at Baseline and absent at Day endpoint. Worsening was defined as absent at Baseline and present at Day endpoint. No Change was defined as no change from Baseline and time point of endpoint.|Baseline, Day 253 (Cohorts 1 to 4) and Day 281 (Cohort 4)|Full Analysis Set: Participants in the safety set with a Baseline and at least 1 LDH measurement after first dose of ravulizumab. Data summarized only for participants with data at Baseline and the specified time point. LOCF is used for participants with a missing Day 253 or Day 281 assessment. Erectile dysfunction affects only male participants.|||Participants|||Count of Participants
2564732|NCT02605993|Secondary|Percent Change In D-dimer From Baseline To Day 253 And Day 281|The percent change in D-dimer levels were assessed from Baseline to Day 253 for Cohorts 1 to 4 and from Baseline to Day 281 for Cohort 4 only.|Baseline to Day 253 (Cohorts 1 to 4) and Day 281 (Cohort 4)|Full Analysis Set: Participants in the safety set with a Baseline and at least 1 LDH measurement after first dose of ravulizumab. Data summarized only for participants with data at Baseline and the specified time point. LOCF is used for participants with a missing Day 253 or Day 281 assessment.|||Percent Change||Standard Deviation|Mean
2564733|NCT02605993|Secondary|Percent Change In PNH RBC Types II And III Clone Size From Baseline To Day 253|The percent change in paroxysmal nocturnal hemoglobinuria (PNH) red blood cell (RBC), summed types II and III, clone size levels were assessed from Baseline to Day 253 for Cohorts 1 to 4.|Baseline, Day 253 (Cohorts 1 to 4)|Full Analysis Set: Participants in the safety set with a Baseline and at least 1 LDH measurement after first dose of ravulizumab. Data summarized only for participants with data at Baseline and the specified time point. LOCF was used for participants with a missing Day 253 assessment.|||Percent Change||Standard Deviation|Mean
2564734|NCT02605993|Secondary|Percent Change In Reticulocyte/Erythrocyte Count From Baseline To Day 253 And Day 281|The percent change in reticulocyte/erythrocyte count levels was assessed from Baseline to Day 253 for Cohorts 1 to 4 and from Baseline to Day 281 for Cohort 4 only.|Baseline, Day 253 (Cohorts 1 to 4) and Day 281 (Cohort 4)|Full Analysis Set: Participants in the safety set with a Baseline and at least 1 LDH measurement after first dose of ravulizumab. Data summarized only for participants with data at Baseline and the specified time point. LOCF was used for participants with a missing Day 253 or Day 281 assessment.|||Percent Change||Standard Deviation|Mean
2564735|NCT02605993|Secondary|Percent Change In Haptoglobin Levels From Baseline To Day 253 And Day 281|The percent change in haptoglobin levels was assessed from Baseline to Day 253 for Cohorts 1 to 4 and from Baseline to Day 281 for Cohort 4 only.|Baseline, Day 253 (Cohorts 1 to 4) and Day 281 (Cohort 4)|Full Analysis Set: Participants in the safety set with a Baseline and at least 1 LDH measurement after first dose of ravulizumab. Data summarized only for participants with data at Baseline and the specified time point. LOCF was used for participants with a missing Day 253 or Day 281 assessment.|||Percent Change||Standard Deviation|Mean
2564736|NCT02605993|Secondary|Percent Change In Free Hemoglobin Levels From Baseline To Day 253 And Day 281|The percent change in free hemoglobin levels was assessed from Baseline to Day 253 for Cohorts 1 to 4 and from Baseline to Day 281 for Cohort 4 only.|Baseline, Day 253 (Cohorts 1 to 4) and Day 281 (Cohort 4)|Full Analysis Set: Participants in the safety set with a Baseline and at least 1 LDH measurement after first dose of ravulizumab. Data summarized only for participants with data at Baseline and the specified time point. LOCF was used for participants with a missing Day 253 or Day 281 assessment.|||Percent Change||Standard Deviation|Mean
2564737|NCT02605993|Primary|Percent Change In LDH Levels From Baseline To Day 253 And Day 281|The percent change in LDH levels was assessed from Baseline to Day 253 for Cohorts 1 to 4 and from Baseline to Day 281 for Cohort 4 only.|Baseline, Day 253 (Cohorts 1 to 4) and Day 281 (Cohort 4)|Full Analysis Set: Participants in the safety set with a Baseline and at least 1 LDH measurement after first dose of ravulizumab. Data summarized only for participants with data at Baseline and the specified time point. Last observation carried forward (LOCF) was used for participants with a missing Day 253 or Day 281 assessment.|||Percent Change||Standard Deviation|Mean
2564738|NCT02605954|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the E/C/F/TAF group with available data were analyzed.|||cells/µL||Standard Deviation|Mean
2564739|NCT02605954|Secondary|Change From Baseline in CD4+ Cell Count at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.|||cells/µL||Standard Deviation|Mean
2564740|NCT02605954|Secondary|Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Only the participants who were randomized to E/C/F/TAF group were analyzed.|||percentage of participants|||Number
2564741|NCT02605954|Secondary|Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 12|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 12 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 12|Full Analysis Set|||percentage of participants|||Number
2564742|NCT02605954|Primary|Percentage of Participants Who Have HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Algorithm at Week 24|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: participants who were randomized and received at least one dose of study drug (either E/C/F/TAF or ABC/3TC+3rd agent on or after Day 1).|||percentage of participants|||Number
2564814|NCT02605187|Secondary|Count of Participants With Presence of Pruritus|Count of participants with pruritus through 48 hours after delivery.|0-24 and 24-48 hours after delivery|Participants who completed the protocol are included in the analysis.|||Participants|||Count of Participants
2564744|NCT02605876|Secondary|Peak Internal Knee Valgus Moment|"Change score (Post-Pre) for the peak internal knee valgus moment during the first 50% of the stance phase. This value reflects the internal (i.e. muscle and other soft tissue) response to external loading of the knee joint in the frontal plane of motion, and is indicative of medial tibiofemoral joint loading during walking. Though a normal value has not been established, typical values for the raw scores (i.e. not change scores) range 2-4 % body weight x height."|Immediately prior to and following the interventions (within 5 minutes)||||% body weight x height||95% Confidence Interval|Mean
2564745|NCT02605876|Secondary|Peak Internal Knee Extension Moment|"Change score (Post-Pre) for the peak internal knee extension moment during the first 50% of the stance phase. This value reflects the internal (i.e. muscle and other soft tissue) response to external loading of the knee joint in the sagittal plane of motion, and is indicative of quadriceps muscle function during walking. Though a normal value has not been established, typical values for the raw scores (i.e. not change scores) range 2-4 % body weight x height."|Immediately prior to and following the interventions (within 5 minutes)||||% body weight x height||95% Confidence Interval|Mean
2564746|NCT02605876|Primary|Instantaneous Ground Reaction Force Loading Rate|"Change score (Post-Pre) loading rate calculated as the peak of the first time derivative of the vertical ground reaction force time series curve during the first 50% of the stance phase. Though a normal value has not been established, typical values for the raw scores (i.e. not change scores) range 50-70 multiples of body weight per second."|Immediately prior to and following the interventions (within 5 minutes)||||multiples of body weight per second||95% Confidence Interval|Mean
2564747|NCT02605876|Primary|Knee Proprioception|Change score (Post-Pre) for the absolute sagittal plane joint reposition error. This value, measured in degrees, represents the absolute difference between a target knee flexion angle and the angle the subject reproduces, and assesses how well the subject can perceive the position of his/her knee in space. Typical values for the raw scores (i.e. not change scores) range from 0.5 - 5 degrees.|Prior to and immediately following vibration interventions (within 5 minutes)||||degrees||95% Confidence Interval|Mean
2564748|NCT02605876|Primary|Quadriceps Strength|"Change score (Post-Pre) for maximal isometric knee extension peak torque in Newton*meters/kilogram body mass. Though a normal value has not been established, typical values for the raw values (i.e. not changes scores) range 1.5-3.5 Newton*meters/kilogram body mass."|Prior to and immediately following vibration interventions (within 10 minutes)||||Newton*meters/kilogram body mass||95% Confidence Interval|Mean
2564749|NCT02605876|Primary|Linear Ground Reaction Force Loading Rate|"Change score (Post-Pre) for the ground reaction force during the first 50% of the stance phase calculated as the slope of the vertical ground reaction force time series curve from heelstrike to the first ground reaction force peak. Though a normal value has not been established, typical values for the raw scores (i.e. not change scores) range 8.5-9.5 multiples of body weight per second."|Prior to and immediately following vibration interventions (within 5 minutes).||||multiples of body weight per second||95% Confidence Interval|Mean
2564750|NCT02605863|Primary|Number of Participants With Recurrent Disease|Bladder cystoscopy, urine cytology, and pathology report|1 year|There were no participants enrolled in the high risk arm.|||Participants|||Count of Participants
2564751|NCT02605837|Secondary|Apparent Volume of Distribution (Vz/F) of Budesonide in Plasma|Vz/F of budesonide in plasma was reported.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Week 8, 12 and 16|PK set included all participants in the safety set who received BOS treatment and provided at least one quantifiable plasma concentration of budesonide. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
2564752|NCT02605837|Secondary|Apparent Oral Clearance (CL/F) of Budesonide in Plasma|CL/F of budesonide in plasma was reported.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Week 8, 12 and 16|PK set included all participants in the safety set who received BOS treatment and provided at least one quantifiable plasma concentration of budesonide. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2564753|NCT02605837|Secondary|Terminal Half-Life (t1/2) of Budesonide in Plasma|t1/2 of budesonide in plasma was reported|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Week 8, 12 and 16|PK set included all participants in the safety set who received BOS treatment and provided at least one quantifiable plasma concentration of budesonide. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||hour||Geometric Coefficient of Variation|Geometric Mean
2564754|NCT02605837|Secondary|Terminal Rate Constant (Lambda Z) of Budesonide in Plasma|Lambda Z of budesonide in plasma was reported.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Week 8, 12 and 16|PK set included all participants in the safety set who received BOS treatment and provided at least one quantifiable plasma concentration of budesonide. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||per hour||Geometric Coefficient of Variation|Geometric Mean
2564755|NCT02605837|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Budesonide in Plasma|Tmax of budesonide in plasma was reported.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Week 8, 12 and 16|PK Set included all participants in the safety set who received BOS treatment and provided at least one quantifiable plasma concentration of budesonide. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||hour||Full Range|Median
2564756|NCT02605837|Secondary|Maximum Observed Concentration (Cmax) of Budesonide in Plasma|The Cmax of budesonide in plasma was reported.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Week 8, 12 and 16|PK set included all participants in the safety set who received BOS treatment and provided at least one quantifiable plasma concentration of budesonide. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Picograms per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2564815|NCT02605187|Secondary|Count of Participants Who Need Opioid Use|Count of participants who need opioid use through 48 hours after delivery.|0-24 and 24-48 hours after delivery|Participants who completed the protocol are included in the analysis.|||Participants|||Count of Participants
2565241|NCT02600715|Secondary|Number of Participants With Evidence of Infection or Positive Urine Culture|Urinalysis results showing evidence of infection or positive urine culture at 2-week follow-up appointment.|2 Weeks|One patient did not complete 2-week follow-up appointment.|||Participants|||Count of Participants
2564757|NCT02605837|Secondary|Area Under the Plasma Concentration-Time Curve (AUCtau) Between the Defined Interval of Budesonide Doses|Area under the curve for the defined interval between doses (12 hours), calculated using the linear-up/log-down trapezoidal rule.The AUCtau of plasma budesonide was reported. Hours times pico grams per milliliter was abbreviated as h.pg/mL.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Week 8, 12 and 16|PK set included all participants in the safety set who received BOS treatment and provided at least one quantifiable plasma concentration of budesonide. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||h.pg/mL||Geometric Coefficient of Variation|Geometric Mean
2564758|NCT02605837|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AE)|An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs that start or deteriorate on or after the first dose of double-blind IP (Week 44) and through the safety follow-up contact, or 31 days after the last dose of IP for participants who did not have a safety follow-up contact. Number of participants with TEAE's were reported.|From start of study drug administration up to follow-up (Week 20)|Safety analysis set included all participants who received at least one dose of any double-blind IP.|||Participants|||Count of Participants
2564759|NCT02605837|Secondary|Change From Baseline in the Dysphagia Symptom Questionnaire (DSQ) Pain Score (Question 4) at the Final Treatment Period Evaluation (Week 16)|DSQ pain score was calculated by summing the scores of responses to Question 4 (extent to which the participant experienced pain while swallowing) only, by using the following formula: DSQ pain score= [(sum of points from question 4 in the daily DSQ)×14]/ Number of diaries reported with non-missing data. Scale range was 0 - 4 for question 4, with higher values representing a worse outcome. Scale range for DSQ pain score was 0 - 56, with higher values representing a worse outcome. A negative change from baseline indicates that symptoms decreased. Change from baseline in DSQ pain score (question 4) after 12 weeks of double blind treatment at Week 16 were reported.|Baseline, Week 16|FAS included all randomized participants who received at least one dose of a double-blind IP. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||score on scale||Standard Error|Least Squares Mean
2564760|NCT02605837|Secondary|Change From Baseline in the Dysphagia Symptom Questionnaire (DSQ) + Pain Score (Questions 2 +3+4) at the Final Treatment Period Evaluation (Week 16)|DSQ contained 4 questions, all participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). DSQ + pain score was calculated by summing the scores of responses to questions 2, 3, and 4 by using following formula: DSQ + pain score= ([sum of points from questions 2+3+4 in the daily DSQ] ×14)/ Number of diaries reported with non-missing data. Scale range was 0 - 2 for question 2, 0 - 4 for question 3 and 0 - 4 for question 4, with higher values representing a worse outcome. Scale range for DSQ + pain score was 0 - 140, with higher values representing a worse outcome. A negative change from baseline indicates that symptoms decreased.|Baseline, Week 16|FAS included all randomized participants who received at least one dose of a double-blind IP. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Score on scale||Standard Error|Least Squares Mean
2564761|NCT02605837|Secondary|Number of Participants With Overall Binary Response II at the Final Treatment Period Evaluation (Week 16)|Overall binary response II was defined as a reduction in the DSQ score of >=50% from baseline to the final treatment period evaluation and a peak eosinophil count of <=6/HPF across all esophageal levels at the final treatment period evaluation. Participant was considered as responder at Week 16 if he/she achieved a minimum of 50% reduction in DSQ combined score between baseline and Week 16 and had peak eosinophil count of <=6/HPF across all esophagus levels. Number of participants with overall binary response II after 12 weeks of double blind treatment at Week 16 were reported.|Week 16|FAS included all randomized participants who received at least one dose of a double-blind IP.|||Participants|||Count of Participants
2564762|NCT02605837|Secondary|Number of Participants With Overall Binary Response I at the Final Treatment Period Evaluation (Week 16)|Overall binary response I was defined as a reduction in the DSQ score of >=30% from baseline to the final treatment period (week 16) evaluation and a peak eosinophil count of <=6/HPF across all esophageal levels at the final treatment period evaluation. Participant was considered as responder at Week 16 if he/she achieved a minimum of 30% reduction in DSQ combined score between baseline and Week 16 and has peak eosinophil count of <=6/HPF across all esophagus levels. Number of participants with overall binary response I after 12 weeks of double blind treatment at Week 16 were reported.|Week 16|FAS included all randomized participants who received at least one dose of a double-blind IP.|||Participants|||Count of Participants
2564763|NCT02605837|Secondary|Number of Participants With Dysphagia Symptom Response (Binary Response) at the Final Treatment Period Evaluation (Week 16)|Dysphagia symptom response (binary response [i.e, responders versus. non-responders]) was defined as a >=50% reduction in the DSQ combined score (questions 2+3), from baseline to the final treatment period evaluation (Week 16). DSQ contained 4 questions, all participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). DSQ score= ([sum of points from questions 2+3 in the daily DSQ]×14)/ Number of diaries reported with non-missing data. Number of participants with binary response after 12 weeks of double blind treatment at Week 16 were reported.|Week 16|FAS included all randomized participants who received at least one dose of a double-blind IP.|||Participants|||Count of Participants
2564773|NCT02605642|Secondary|Change From Baseline in Physician Global Assessment (PGA) of Rheumatoid Diseases Activity at Months 6, 12, 18 and 24|PGA of disease activity was measured on a 0 to 100 mm VAS, where 0 mm = no disease activity and 100 mm = extremely active. Higher scores indicated worsening of condition.|Baseline, Months 6, 12, 18 and 24|Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of PGA. Here ‘Number analyzed’ = Participants evaluable for this outcome measure at specified rows.|||millimeters||Standard Deviation|Mean
2564764|NCT02605837|Secondary|Change From Baseline in the Histopathologic Epithelial Features Combined Total Score Ratio (TSR) at the Final Treatment Period Evaluation (Week 16)|Change from baseline in histopathologic epithelial features combined total score of grade and stage ratio after 12 weeks of double blind treatment at Week 16 were reported by measuring eight histopathologic epithelial features: basal layer hyperplasia, eosinophil density, eosinophil micro-abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells, lamina propria fibrosis were scored on a 4-point scale (0=normal, 3=worst) for both the severity of the abnormality (grade) and the amount of tissue affected by the abnormality (stage). Thus each of the 3 levels had a minimum score of 0 and maximum possible score of 24, and a possible total grade or stage score of 72 for a maximum combined score of 144. Combined total score ratio (TSR) =(proximal TSR + mid TSR + distal TSR)/N, where N is the number of non missing sections for TSR. A negative change from baseline indicates that epithelial inflammation decreased.|Baseline, Week 16|FAS included all randomized participants who received at least one dose of a double-blind IP. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||score on scale||Standard Error|Least Squares Mean
2564765|NCT02605837|Secondary|Change From Baseline in the Peak Eosinophil Count at the Final Treatment Period Evaluation (Week 16)|Change from baseline in the peak eosinophil count after 12 weeks of double blind treatment at week 16 for each available esophageal level (proximal, mid, distal, maximum) were reported.|Baseline, Week 16|FAS included all randomized participants who received at least one dose of a double-blind IP. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure at each specific category.|||eosinophil count||Standard Error|Least Squares Mean
2564766|NCT02605837|Secondary|Number of Participants With Peak Eosinophil Count Less Than (<)15/High-Powered Field (HPF) or Less Than or Equal to (<=)1/High-Powered Field (HPF) at the Final Treatment Period Evaluation (Week 16)|Participant was considered as responder at Week 16 if he/she had peak eosinophil count of <15/HPF or <=1/HPF across all esophagus levels. Number of participants with peak eosinophil count < 15/HPF or <=1/HPF after 12 weeks of double blind treatment at Week 16 were reported.|Week 16|FAS included all randomized participants who received at least one dose of a double-blind IP.|||Participants|||Count of Participants
2564767|NCT02605837|Secondary|Change From Baseline in Total Endoscopy Score at the Final Treatment Period Evaluation (Week 16)|Endoscopic findings with separate evaluations of the proximal and distal esophagus were recorded with respect to 5 categories: 1) exudates or plaques (grade 0-2); 2) fixed esophageal rings (grade 0-3); 3) edema (grade 0-2); 4) furrows (grade 0-2); and 5) strictures (grade 0-1). An endoscopy score for each category was calculated and summed for each anatomic location (proximal and distal). The minimum and maximum endoscopy score was 0 and 10 points respectively for each location (proximal and distal) and the total endoscopy score was the sum of the scores for the proximal and distal locations (maximum total score of 20 points respectively). The higher score indicated worse appearance. A negative change from baseline indicates that appearance improved. Endoscopic findings after 12 weeks of double blind treatment at Week 16 were reported.|Baseline, Week 16|FAS included all randomized participants who received at least one dose of a double-blind IP. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||score on scale||Standard Error|Least Squares Mean
2564768|NCT02605837|Secondary|Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Combined Score at the Final Treatment Period Evaluation (Week 16)|DSQ contained 4 questions, all participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). DSQ combined score= ([sum of points from questions 2+3 in the daily DSQ]×14)/ Number of diaries reported with non-missing data. Scale range was 0 - 2 for question 2 and 0 - 4 for question 3, with higher values representing a worse outcome. Scale range for DSQ combined score was 0 - 84, with higher values representing a worse outcome. A negative change from baseline indicates that symptoms decreased. Change from baseline in DSQ after 12 weeks of double blind treatment at Week 16 was reported.|Baseline, Week 16|FAS included all randomized participants who received at least one dose of a double-blind IP. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Score on scale||Standard Error|Least Squares Mean
2564769|NCT02605837|Primary|Number of Participants With Dysphagia Symptom Response at the Final Treatment Period Evaluation (Week 16)|Dysphagia symptom response was defined as greater than or equal to (>=) 30 percent (%) reduction in the Dysphagia Symptom Questionnaire (DSQ) combined score (questions 2+3). DSQ contained 4 questions, all participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). DSQ score= ([sum of points from questions 2+3 in the daily DSQ]×14)/ Number of diaries reported with non-missing data. Dysphagia symptom response after 12 weeks of double blind treatment at Week 16 was reported.|Week 16|FAS included all randomized participants who received at least one dose of a double-blind IP.|||Participants|||Count of Participants
2564770|NCT02605837|Primary|Number of Participants With Histologic Response at the Final Treatment Period Evaluation (Week 16)|Histologic response was defined as a peak eosinophil count of less than or equal to (<=) 6/ high-powered field (HPF) across all available esophageal levels at final treatment period evaluation (Week 16). Histologic response after 12 weeks of double blind treatment at Week 16 was reported.|Week 16|FAS included all randomized participants who received at least one dose of a double-blind IP.|||Participants|||Count of Participants
2564771|NCT02605824|Secondary|Change CT Mucus Score|The CT Mucus Score describes the number of segments of the lungs that are impacted by mucus. This outcome will compare the change in CT mucus score both at baseline and following each treatment period.|7 days|Only one subject was enrolled into the intervention, and after taking the first dose of NAC, they experienced excessive bronchospasm thus making them ineligible to continue and complete the study.||||||
2565242|NCT02600715|Secondary|Post Void Residual (PVR)|Distribution of patients with volume in ml of post-void residual urine obtained via catheter greater than 200 ml at 2-week follow-up appointment.|2 Weeks|One patient did not complete 2-week follow-up post-void residual exam.|||Participants|||Count of Participants
2564774|NCT02605642|Secondary|Change From Baseline in Mental Component Summary (MCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24|The SF-12v2 is a self-administered, validated, multipurpose SF questionnaire to measure generic health status. It consists of 12 items, which are categorized into eight domains (subscales) of functioning and well-being: physical function, role limitations due to physical problems, bodily pain, general health perceptions, energy and vitality, social functioning, role limitations due to emotional problems, and mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. These eight domains are further summarized into PCS and mental component summary (MCS). The score range for each of these 2 summary scores was from 0 (poor health) to 100 (better health). Higher scores indicated a better health-related quality of life.|Baseline, Months 6, 12, 18 and 24|Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of SF-12v2. Here ‘Number analyzed’ = Participants evaluable for this outcome measure at specified rows.|||units on a scale||Standard Deviation|Mean
2564775|NCT02605642|Secondary|Change From Baseline in Physical Component Summary (PCS) Score of Short Form 12 Version 2 (SF-12v2) Health Survey at Months 6, 12, 18 and 24|The SF-12v2 is a self-administered, validated, multipurpose SF questionnaire to measure generic health status. It consists of 12 items, which are categorized into eight domains (subscales) of functioning and well-being: physical function, role limitations due to physical problems, bodily pain, general health perceptions, energy and vitality, social functioning, role limitations due to emotional problems, and mental health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. These eight domains are further summarized into PCS and mental component summary (MCS). The score range for each of these 2 summary scores was from 0 (poor health) to 100 (better health). Higher scores indicated a better health-related quality of life.|Baseline, Months 6, 12, 18 and 24|Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of SF-12v2. Here ‘Number analyzed’ = Participants evaluable for this outcome measure at specified rows.|||units on a scale||Standard Deviation|Mean
2564776|NCT02605642|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-3 Levels (EQ-5D-3L) Index Score at Months 6, 12, 18 and 24|EQ-5D-3L is a standardized, participant-administered measure of self-reported health outcomes. It consists of two parts: EQ-5D descriptive system (Part I) and the EQ-VAS (Part II). For Part I, i.e. EQ-5D-3L index score, participants rated their current health state on 5 single-item dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with each dimension having three levels of function:. 1=no problems, 2=some problems and 3=extreme problems. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of -0.074 to 1.00; higher scores indicating a better health state.|Baseline, Months 6, 12, 18 and 24|Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of EQ-5D-3L. Here ‘Number analyzed’ = Participants evaluable for this outcome measure at specified rows.|||units on a scale||Standard Deviation|Mean
2564777|NCT02605642|Secondary|Change From Baseline in European Quality of Life- 5 Dimensions 3 Level Version (EQ-5D-3L) Visual Analog Scale (VAS) Score at Months 6, 12, 18 and 24|EQ-5D-3L is a standardized, participant-administered measure of health outcomes. It consists of two parts: EQ-5D descriptive system (Part I) and the EQ-VAS (Part II). EQ-5D-3L Part II uses a vertical graduated VAS to measure health status on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state.|Baseline, Months 6, 12, 18 and 24|Analysis was performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of EQ-5D-3L. Here ‘Number analyzed’ = Participants evaluable for this outcome measure at specified rows.|||units on a scale||Standard Deviation|Mean
2564778|NCT02605642|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Months 6, 12, 18 and 24|"HAQ-DI assesses the degree of difficulty a participant had experienced in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale from 0 to 3 with 0 =no difficulty, 1 =some difficulty, 2 = much difficulty, and 3 =unable to do. Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 = no difficulty to 3 =unable to do. Higher score indicate more difficulty in performing daily living activities."|Baseline, Months 6, 12, 18 and 24|Analysis performed on participants who had received at least one dose of CT-P13 during the study observation period and had at least one post-dose assessment of HAQ-DI. Here ‘Number analyzed’ = Participants evaluable for this outcome measure at specified rows.|||units on a scale||Standard Deviation|Mean
2564779|NCT02605642|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24|BASFI is a validated self assessment tool to determine the degree of functional limitation in participants with AS. It is comprised of 10 questions which were answered by participants using a VAS ranging from 0 (being easy) to 10 (impossible). BASFI total score was calculated as the average score of the 10 questions, and ranges from 0 (no functional impairment) to 10 (maximal impairment), higher scores indicated more impairment.|Baseline, Weeks 6, 12, 18 and 24|Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for BASFI. ‘Overall number of participants analyzed’: participants who were evaluable for this outcome measure. ‘Number analyzed’ = Participants evaluable for this outcome measure at specified rows.|||units on a scale||Standard Deviation|Mean
2564788|NCT02605642|Primary|Number of Participants by Initial Frequency of CT-P13 Infusion Received|Initial frequency of CT-P13 infusion was categorized as: once every 4, 6, 8 weeks and other. 'Other' included all other frequencies other than specified. Number of participants by baseline infusion frequency (in weeks) were reported.|Baseline (Day 1) of 2 year observation period|The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. Here “Overall number of participants analyzed” signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2564780|NCT02605642|Secondary|Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis (AS) at Months 6,12,18 and 24|ASDAS is used to assess disease activity in participants with AS. It is a score combining the assessment of overall pain (Q1), duration of morning stiffness (Q2), peripheral pain/swelling (Q3), PtGA (assessed on a sale of 0 to 10, where 0 = not active and 10=very active), and C-reactive protein (CRP) in milligrams per liter (mg/L). ASDAS total score was derived using the following formula: ASDAS=0.12*Q1+0.06*Q2+0.11*GH+0.07*Q3+0.58*ln (CRP+1). The level of AS disease activity was interpreted as inactive disease (ASDAS< 1.3), moderate disease activity (1.3 <= ASDAS < 2.1), high disease activity (2.1<= ASDAS <=3.5) and very high disease activity (ASDAS > 3.5).|Baseline, Weeks 6, 12, 18 and 24|Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for ASDAS. ‘Overall number of participants analyzed’: participants who were evaluable for this outcome measure. ‘Number analyzed’ = Participants evaluable for this outcome measure at specified rows.|||units on a scale||Standard Deviation|Mean
2564781|NCT02605642|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in Participants With Ankylosing Spondylitis (AS) at Months 6, 12, 18 and 24|BASDAI is a self-reported measure of disease activity in participants with AS. Participants answered 6 questions measuring symptoms of AS (fatigue, spinal pain, joint pain or swelling, areas of localized tenderness, morning stiffness duration and severity). The BASDAI total score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score was then divided by 5. BASDAI=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The total BASDAI score ranges from 1=none to 10=severe, where lower score indicated less disease activity. The level of AS disease activity was interpreted as low (BASDAI < 4) or high (BASDAI > 4).|Baseline, Weeks 6, 12, 18 and 24|Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for BASDAI. ‘Overall number of participants analyzed’: participants who were evaluable for this outcome measure. ‘Number analyzed’ = Participants evaluable for this outcome measure at specified rows.|||units on a scale||Standard Deviation|Mean
2564782|NCT02605642|Secondary|Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Psoriatic Arthritis (PsA) at Months 6, 12, 18 and 24|DAS28 calculated from the number of TJC and SJC using 28 joints count, ESR (millimeters per hour; ranged from 0 to 150), and participant's GH on a 100 mm VAS (ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worsening of health condition). Total DAS28 score ranged from 0 (none) to 9.4 (extreme disease activity), higher scores indicated more disease activity. DAS28 <= 3.2 implied low, > 3.2 to <=5.1 implied moderate, and >5.1 implied high disease activity. DAS28=0.56*sqrt(28TJC)+0.28*sqrt(28SJC)+0.70*ln(ESR)+0.014*GH; where ln = natural logarithm and sqrt = square root of.|Baseline, Months 6, 12, 18 and 24|Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for DAS28. ‘Overall number of participants analyzed’: participants who were evaluable for this outcome measure. ‘Number analyzed’ = Participants evaluable for this outcome measure at specified rows.|||units on a scale||Standard Deviation|Mean
2564783|NCT02605642|Secondary|Change From Baseline in Disease Activity Score-28 (DAS28) in Participants With Rheumatoid Arthritis (RA) at Months 6, 12, 18 and 24|DAS28 calculated from the number of tender joint count (TJC) and swollen joint count (SJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters per hour; ranged from 0 to 150), and a participant's general health assessment (GH) on a 100 millimeter (mm) visual analog scale (VAS) (ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worsening of health condition). Total DAS28 score ranged from 0 (none) to 9.4 (extreme disease activity), higher scores indicated more disease activity. DAS28 less than or equal to (<=) 3.2 implied low, greater than (>) 3.2 to <=5.1 implied moderate, and >5.1 implied high disease activity. DAS28=0.56*sqrt(28TJC)+0.28*sqrt(28SJC)+0.70*ln(ESR)+0.014*GH; where ln = natural logarithm and sqrt = square root of.|Baseline, Months 6, 12, 18 and 24|Analysis performed on participants who had received at least one dose of CT-P13 and had at least one post-dose assessment for DAS28. ‘Overall number of participants analyzed’: participants who were evaluable for this outcome measure. ‘Number analyzed’ = Participants evaluable for this outcome measure at specified rows.|||units on a scale||Standard Deviation|Mean
2564784|NCT02605642|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of infusion up to 2 years, that were absent before treatment or that worsened relative to pretreatment state. Serious infections including sepsis (excluding opportunistic infections and tuberculosis) were the pre-defined TEAE of special Interest for this study. AEs included both serious and non-serious adverse events.|During the observation period of 2 years|The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.|||Participants|||Count of Participants
2564785|NCT02605642|Primary|Number of Participants Who Had At Least One Concomitant Medication Related to the Treatment of Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)|Concomitant medications included corticosteroids, non-steroidal anti- inflammatory drugs (NSAID'S) and immunosuppressant. Participants were counted in more than one categories. 'Others' included DMARDS and other medications apart from the categories specified.|During the observation period of 2 years|The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.|||Participants|||Count of Participants
2564786|NCT02605642|Primary|Number of Participants With Change in CT-P13 Infusion Dose|Participants who had change in the dose of infusion (either dose reduction or increase in dose) during the observation period were reported.|During the observation period of 2 years|The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.|||Participants|||Count of Participants
2564787|NCT02605642|Primary|Total Dose of CT-P13 Infusion Received During Observation Period|Total dose of infusion received by the participants were evaluated.|During the observation period of 2 years|The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.|||milligram per kilogram||Full Range|Median
2564790|NCT02605642|Primary|Disease Duration in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA), as Recorded on the Day of Inclusion in Study|Disease duration was defined as the number of months from initial diagnosis of rheumatoid disease (RA, AS or PsA) to the date of informed consent, which was recorded at the time of inclusion in the study (Day 1).|At Day 1 of 2 year observation period|The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified rows.|||months||Full Range|Median
2564791|NCT02605642|Primary|Treatment Persistence With CT-P13 in Participants With Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA)|Persistence (in days) was defined as a continuous variable measured in time from index date until date of drug discontinuation. Drug discontinuation was defined as either switching to another non infliximab BDMARD or elapsing of a drug free interval of 16 weeks from CT-P13. For participants undergoing a switch to CT-P13 from Remicade, the index date was considered the date from which Remicade was originally commenced and for participants who initiated treatment with CT-P13 as their first biologic, the index date was considered the date from which CT-P13 was initiated.|During the observation period of 2 years|The safety population was defined as all participants who received at least one dose of CT-P13 during the study observation period.|||days||Standard Deviation|Mean
2564792|NCT02605395|Secondary|Mean Terminal Half Life (t1/2) of Rabeprazole|Half life is the period of time required for the concentration or amount of drug in the body to be reduced by one-half. Blood samples were collected for pharmacokinetic analysis in each period at specified time points. Pharmacokinetic parameters of Rabeprazole were estimated using standard non-compartmental methods. t1/2 was calculated as: t1/2 = Ln(2) / (-b), where b was obtained as the slope of the linear regression of the Ln-transformed plasma concentrations versus time in the terminal period of the plasma curve.|Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2|All subject population|||Hour||Standard Deviation|Mean
2564793|NCT02605395|Secondary|Mean Apparent First-order Elimination or Terminal Rate Constant (Ke) of Rabeprazole|Blood samples were collected for pharmacokinetic analysis in each period at specified time points. Pharmacokinetic parameters of Rabeprazole were estimated using standard non-compartmental methods. Ke was derived from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.|Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2|All subject population|||Per hour||Standard Deviation|Mean
2564794|NCT02605395|Secondary|Mean Time to the Maximum Plasma Concentration (Tmax) of Rabeprazole|Blood samples were collected for pharmacokinetic analysis in each period at specified time points. Pharmacokinetic parameters of Rabeprazole were estimated using standard non-compartmental methods. Tmax was computed directly from the measured data.|Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2|All subject population.|||Hour||Standard Deviation|Mean
2564795|NCT02605395|Primary|Mean Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC [0 to Infinity]) of Rabeprazole|Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods.|Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2|All subject population.|||Hour*nanograms per milliliter||Standard Deviation|Mean
2564796|NCT02605395|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC [0-t]) of Rabeprazole|Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods. AUC (0-t) was calculated from measured data points from time of administration to time of last quantifiable concentration (Clast) by the linear trapezoidal rule.|Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2|All subject population.|||Hour*nanograms per milliliter||Standard Deviation|Mean
2564797|NCT02605395|Primary|Maximal Measured Plasma Concentration (Cmax) of Rabeprazole|Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods. The Cmax was computed directly from measured data.|Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2|All subject population comprised of all participants who received at least one dose of study medication.|||Nanograms per milliliter||Standard Deviation|Mean
2564798|NCT02605304|Secondary|CD4+ T-cell (CD4) Count Change From Baseline|Change in CD4 count was calculated as value at the post entry visit minus the value at study entry.|Entry and at 12 (and 24 in Arm B) weeks after study entry|All participants enrolled with CD4 result available at entry and at the post-entry visit.|||cells/mm^3||Inter-Quartile Range|Median
2564799|NCT02605304|Secondary|Number of Participants With HIV-1 RNA >50 Copies/mL|HIV-1 RNA testing was performed at a central laboratory using Abbott RealTime HIV-1 assay (Abbott Laboratories, Lake Bluff, IL, USA).|Entry (Week 0); at 4, 12 (and 24 in Arm B) weeks after study entry, and at 4 weeks after treatment discontinuation|All participants enrolled with HIV-1 RNA results available at the visit.|||Participants|||Count of Participants
2564800|NCT02605304|Secondary|Number of Participants With Unquantifiable HCV RNA|Unquantifiable HCV was defined as HCV RNA below the LLOQ of the assay (15 IU/mL), either TD or TND. HCV RNA testing was conducted at a central laboratory using the COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, version 2.0 (Roche Diagnostics, Rotkreuz, Switzerland).|Entry (Week 0); at 1, 4, 8, 12 (and 16, 20, 24 in Arm B) weeks after study entry|All participants enrolled who had HCV RNA results available at the visit.|||Participants|||Count of Participants
2564816|NCT02605187|Primary|Pain Scores|Pain scores at rest and at movement post-cesarean delivery. Score was rated on a scale from 0 to 10, where 0=no pain and 10=worst imaginable pain.|3, 6, 12, 24, 36 and 48 hours after delivery|Participants who completed the protocol are included in the analysis.|||units on a scale||Standard Deviation|Mean
2565794|NCT02589171|Secondary|Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale|Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.|6 weeks||||units on a scale||Standard Deviation|Mean
2564801|NCT02605304|Secondary|Percentage of Participants With Sustained Virologic Response at 24 Weeks After Treatment Discontinuation (SVR24)|SVR24 was defined as HCV RNA below the LLOQ of the assay (either TD or TND) at 24 weeks after treatment discontinuation. The sample from a visit greater than 20 weeks after treatment discontinuation which was closest to the targeted week (24 weeks post treatment), not followed by any HCV RNA result ≥LLOQ, was used. If there was no HCV RNA sample within this window, then the participant was considered not to have achieved SVR24. HCV RNA testing was conducted at a central laboratory using the COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, version 2.0 (Roche Diagnostics, Rotkreuz, Switzerland). Wilson (score) method was used for confidence intervals.|At 24 weeks after treatment discontinuation (i.e., at 36 weeks after study entry in Arm A and at 48 weeks after study entry in Arm B).|All participants enrolled.|||percentage of participants||90% Confidence Interval|Number
2564802|NCT02605304|Secondary|Percentage of Participants With Sustained Virologic Response at 4 Weeks After Treatment Discontinuation (SVR4)|SVR4 was defined as HCV RNA below the LLOQ of the assay (either TD or TND) at 4 weeks after treatment discontinuation. The sample within the visit window, closest to the targeted time was used. If there was no HCV RNA sample within visit window, then the participant was considered not to have achieved SVR4, unless there were preceding and subsequent HCV RNA measurements that were both <LLOQ (either TD or TND). HCV RNA testing was conducted at a central laboratory using the COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, version 2.0 (Roche Diagnostics, Rotkreuz, Switzerland). Wilson (score) method was used for confidence intervals.|At 4 weeks after treatment discontinuation (i.e., at 16 weeks after study entry in Arm A and at 28 weeks after study entry in Arm B).|All participants enrolled.|||percentage of participants||90% Confidence Interval|Number
2564803|NCT02605304|Secondary|Percentage of Participants With Protocol-specified Renal Events|The study protocol defined renal events as (1) ≥Grade 2 creatinine clearance (CRCL) after study entry, or (2) new urinalysis proteinuria and/or glucosuria, defined as ≥1+ or an increase ≥1+ from baseline. The percentage of participants who experienced any renal event, and the percentages of participants who experienced each component of the outcome are provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple events. Each participant is counted at most once within category, and in the overall summary line.|From study entry to study completion (Week 36 in Arm A, Week 48 in Arm B)|All participants enrolled.|||percentage of participants|||Number
2564804|NCT02605304|Primary|Percentage of Participants With Grade 3 or Higher Adverse Event (AE), Serious AE (SAE), or AE Reported as the Reason for Permanent Discontinuation of Study Treatment|Percentage of participants who experienced an AE (diagnosis, sign/symptom or laboratory abnormality) of ≥Grade 3, SAE according to International Conference on Harmonisation (ICH) criteria, or AE reported as the reason for permanent study treatment discontinuation, during study treatment and up to 30 days after study treatment. Events that were ongoing at the same grade from prior to study treatment initiation were excluded. AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (V2.0) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening. The percentage of participants who experienced any event (overall), and the percentage of participants who experienced each component of the outcome are provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple events. Each participant is counted at most once within category, and in the overall summary line.|From study treatment initiation to 30 days after study treatment discontinuation. Duration of treatment was 12 weeks in Arm A and 24 weeks in Arm B.|All participants enrolled.|||percentage of participants|||Number
2564805|NCT02605304|Primary|Percentage of Participants With Sustained Virologic Response at 12 Weeks After Treatment Discontinuation (SVR12)|SVR12 was defined as HCV RNA below the LLOQ of the assay (either target detected [TD] or target not detected [TND]) at 12 weeks after treatment discontinuation. The sample within the visit window, closest to the targeted time was used. If there was no HCV RNA sample within visit window, then the participant was considered not to have achieved SVR12, unless there were preceding and subsequent HCV RNA measurements that were both <LLOQ (either TD or TND). HCV RNA testing was conducted at a central laboratory using the COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, version 2.0 (Roche Diagnostics, Rotkreuz, Switzerland). Wilson (score) method was used for confidence intervals.|At 12 weeks after treatment discontinuation (i.e., at 24 weeks after study entry in Arm A and at 36 weeks after study entry in Arm B).|All participants enrolled.|||percentage of participants||90% Confidence Interval|Number
2564806|NCT02605187|Secondary|Patient Overall Satisfaction With Postoperative Analgesia|Score was rated on a scale from 0 to 100, where 0=completely unsatisfied and 100=completely satisfied.|24 and 48 hours after delivery|Participants who completed the protocol are included in the analysis.|||units on a scale||Standard Deviation|Mean
2564807|NCT02605187|Secondary|Time to Discharge|Minutes from delivery until discharge.|Delivery through discharge (average 4 days)|Participants who completed the protocol are included in the analysis.|||minutes||Standard Deviation|Mean
2564808|NCT02605187|Secondary|Average Number of Vomiting Episodes After Delivery||0-24 and 24-48 hours after delivery|Participants who completed the protocol are included in the analysis.|||vomiting episodes||Standard Deviation|Mean
2564809|NCT02605187|Secondary|Counts of Participants Who Need Medical Treatment for Nausea|Counts of participants who need medical treatment of nausea through 48 hours after delivery.|0-24 and 24-48 hours after delivery|Participants who completed the protocol are included in the analysis.|||Participants|||Count of Participants
2564810|NCT02605187|Secondary|Nausea Score Score at 24 and 48 After Delivery|Score was rated on a scale from 0 to 10, where 0=no nausea and 10=most nausea.|0-24 and 24-48 hours after delivery|Participants who completed the protocol are included in the analysis.|||units on a scale||Standard Deviation|Mean
2564811|NCT02605187|Secondary|Counts of Participants With Presence of Nausea|Count of participants with nausea through 48 hours after delivery.|0-48 hours after delivery|Participants who completed the protocol are included in the analysis.|||Participants|||Count of Participants
2564812|NCT02605187|Secondary|Count of Participants Who Need Medical Treatment of Pruritus|Count of participants who need medical treatment of pruritus during first 48 hours after delivery.|0-24 and 24-48 hours after delivery|Participants who completed the protocol are included in the analysis.|||Participants|||Count of Participants
2565795|NCT02589171|Secondary|Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale|Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.|1 week||||units on a scale||Standard Deviation|Mean
2564818|NCT02605174|Other Pre-specified|Number of Participants With Treatment Emergent Events|Safety and Tolerability was assessed by the number of participants with at least 1 treatment emergent event (TEAE). A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section|From Baseline Up to End of Study (Up to 11 Weeks)|All randomized participants who had received at least one dose of study drug. Results are displayed by the first dose taken.|||participants|||Number
2564819|NCT02605174|Other Pre-specified|Percentage of Participants With Resource Utilization|Use of health care for treatment 6 months prior to enrolling in the study and information reported during time on study|6 Months Prior to Enrolling in Study to End of Study (Up to 11 Weeks) Within 7 Days of Treating a Single Migraine Attack|All randomized participants who had received at least one dose of study drug and had evaluable resource utilization data.|||percentage of participants|||Number
2564820|NCT02605174|Other Pre-specified|Percentage of Participants With Photophobia Free|The percentage of participants without photophobia.|2 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable photophobia free data.|||percentage of participants|||Number
2564821|NCT02605174|Other Pre-specified|Percentage of Participants With Phonophobia Free|The percentage of participants without phonophobia.|2 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable phonophobia free data.|||percentage of participants|||Number
2564822|NCT02605174|Other Pre-specified|Percentage of Participants Nausea Free|The percentage of participant without nausea.|2 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable nausea free data.|||percentage of participants|||Number
2564823|NCT02605174|Other Pre-specified|Percentage of Participants Use of Rescue Medication|The percentage of participants who used rescue medication.|From 24 Post Dose Up to 48 Hours|All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.|||percentage of participants|||Number
2564824|NCT02605174|Other Pre-specified|Percentage of Participants Use of Rescue Medication|The percentage of participants who used rescue medication.|From 2 Hours Post Dose Up to 24 Hours|All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.|||percentage of participants|||Number
2564825|NCT02605174|Other Pre-specified|Percentage of Participants Use of Rescue Medication|The percentage of participants who used rescue medication.|2 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.|||percentage of participants|||Number
2564826|NCT02605174|Other Pre-specified|Number of Participants With Headache Recurrence|The number of participants with headache recurrence (moderate or severe at baseline which became pain-free at 2 hours post dose and worsened again up to 48 hours post dose)|From 2 Hours Post Dose Up to 48 Hours|All randomized participants who received at least one dose of study drug and had evaluable headache recurrence data.|||Participants|||Count of Participants
2564827|NCT02605174|Other Pre-specified|Percentage of Participants With Headache Relief|The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.|2 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable headache relief data.|||percentage of participants|||Number
2564828|NCT02605174|Primary|Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free|The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.|2 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable MBS data.|||percentage of participants|||Number
2564829|NCT02605174|Primary|Percentage of Participants Headache Pain Free at 2 Hours Post Dose|The percentage of participants defined as mild, moderate, or severe headache pain becoming none.|2 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable headache pain free data.|||percentage of participants|||Number
2564830|NCT02605122|Secondary|Summary of Clinical Cure|Clinical cure was assessed using the latest efficacy evaluation conducted on Day 16 (+/- 4 days) post-randomization, and was defined as resolution of all presenting signs/symptoms of CABP (excluding cough), no development of new signs/symptoms of CABP, and no requirement for an additional antibiotic.|Short-term follow-up at 16 days (+/- 4 days)|Not all subjects had the Clinical cure assessment performed.|||percentage of participants||95% Confidence Interval|Number
2564831|NCT02605122|Secondary|Summary of Clinical Improvement|Clinical improvement was assessed using the latest efficacy evaluation conducted on last day of treatment (+48 hours), and was defined identically to the early clinical response.|Last day of Treatment (+48 hours)|Not all subjects had the Clinical Improvement assessment performed.|||percentage of participants||95% Confidence Interval|Number
2564832|NCT02605122|Secondary|Summary of Early Clinical Response|Early clinical response (ECR) was defined using the latest efficacy evaluation from Day 2 (if subject discharged prior to Day 2), Day3, or Day 4, and was defined as improvement in at least 1 presenting sign/symptom of CABP with no deterioration in any signs/symptoms of CABP and no requirement for an additional antibiotic.|During Treatment Days 3 to 4|Not all subjects had the Early Clinical Improvement assessment performed.|||percentage of participants||95% Confidence Interval|Number
2564833|NCT02605122|Primary|Overview of Adverse Events By Treatment Arm|Summary of subjects experiencing Treatment Emergent Adverse Events (TEAE) through Day 16 visit and Treatment Emergent Serious Adverse Events (TESAE) through Day 28 visit (28 days +/- 4 days after randomization)|Up to 28 days post-treatment|Treatment through Day 28 (28 days +/- 4days after randomization)|||Participants|||Count of Participants
2564834|NCT02604810|Secondary|Mean Steady-state Trough (Pre-dose) Concentration of Total IgG Following IV Administration of IGIV-C 10% or SC Administration of IGSC 20%||For intravenous infusion, pre-dose at Week 1 and Week 3 or Week 4 and for subcutaneous infusion, predose at Weeks 13, 14, 17, and 21||||mg/dL||Full Range|Mean
2564851|NCT02604550|Secondary|Number of Percocet Tablets Consumed|Participants recorded the total number of Percocet 7.5/325 (acetaminophen and oxycodone) tablets they took every day, in order to assess post-surgical use of opioids between the study arms,|Post surgery, Day 0 to Day 6|This analysis includes participants who completed the study and used a smartphone application to record the number of Percocet tablets taken for 6 days post-surgery.|||count of tablets||Standard Deviation|Mean
2564835|NCT02604810|Primary|AUC in the IV Phase and SC Phases: Steady-state AUC of Total IgG Over a Regular Dosing Interval|The primary PK endpoint (steady-state AUC values) analysis was performed using analysis of variance (ANOVA) using PK data from a total of 49 subjects from the IV phase and 39 subjects from the SC phase.|For intravenous infusion, predose, 0,1,3-16 hours and 1,2,3,5,7,14,21 or 28 days (2, 7, 21, or 28 days for pediatric subjects) post-dose and for subcutaneous infusion, pre-dose,1,3,4,5,7 days (3 and 7 days for pediatric subjects) post-dose|The PK population consisted of all subjects who received study drugs and had sufficient and valid total IgG concentration versus time data for either the IV or SC Phase to allow calculation of AUC0-τ,SC or AUC0-τ,IV (the primary PK endpoint).|||h*mg/dL||90% Confidence Interval|Geometric Mean
2564836|NCT02604589|Secondary|Surgical Intensive Care Unit (SICU) Length of Stay|Integer days of admission to the surgical intensive care unit. For patients not requiring admission to surgical intensive care, patient is not analyzed. Usual range is 3-5 days.|from admission to Surgical Intensive Care unit to discharge from Surgical Intensive Care Unit|Only patients analyzed who had surgical intensive care unit admission.|||days||Standard Deviation|Mean
2564837|NCT02604589|Secondary|Hospital Length of Stay|Integer days of inpatient admission in the hospital stay that included randomization.|from randomization to discharge, usually within the range of 5-15 days|One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. This leaves only one subject to analyze, so standard deviation =0|||days||Standard Deviation|Mean
2564838|NCT02604589|Secondary|Mortality|All cause death, death associated with infusion catheter, within 30 days from date of randomization. This outcome will be scored as yes/no and cause of death will be collected.|30 days|One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group|||Participants|||Count of Participants
2564839|NCT02604589|Secondary|Morbidity|Collection of complications observed at any point during the hospital admission that included randomization, including pneumothorax, hemothorax, acute respiratory distress syndrome, pneumonia, empyema, need for tracheostomy, need for mechanical ventilation, length of time on mechanical ventilation, and an assessment of the degree of association of each event with the catheter insertion procedure or with underlying trauma. Each of these outcomes will be scored as yes/no.|3 days or hospital length of stay, whichever is longer|One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group|||number of complications|||Number
2564840|NCT02604589|Secondary|Time to Improvement in Pain Intensity|Determine the impact of catheter-infused medications on self-reported pain intensity reported as a change from baseline (admission) at 24, 48, 72 hours and at 3 days post catheter placement or at discharge (or PCA placement in comparator group) on a 0-10 point Likert scale, with 0=no pain, and 10= the worst pain ever. Response will be defined as time to a decrease of at least two points on the scale.|3 days or hospital length of stay, if less than 3 days|One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. Only one subject remains to be analyzed in that group so standard deviation = 0|||days||Standard Deviation|Mean
2564841|NCT02604589|Secondary|Time to Improvement in Pulmonary Function|Determine the impact of catheter-infused medications on maximal inspiratory lung volume measured by incentive spirometer (IS) as a change from baseline at 24, 48, 72 hours and at 3 days post catheter placement or at discharge (or PCA placement in comparator group). Endpoint will be the time to improvement of vital capacity to greater than 1.4 liters (or 15 mL/kg).|3 days or hospital length of stay, if less than 3 days|One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group. This leaves only one member to analyze; therefore standard deviation = 0.|||days||Standard Deviation|Mean
2564842|NCT02604589|Primary|Narcotic Use|Quantity of systemic narcotic used (hydromorphone hydrochloride, Dilaudid) averaged per day over the length of hospital stay, in mg/24 hours.|3 days or hospital length of stay, if less than 3 days|One subject withdrawn in Bupivicaine 0.5% (HIGH DOSE) group|||mg/24 hours over days 1-3||Standard Deviation|Mean
2564843|NCT02604550|Secondary|"Percent of Patients Rating Their Satisfaction as Excellent or Good"|Patient satisfaction will be reported on a scale of excellent, good, satisfactory, or poor, two weeks following surgery.|2 Weeks Post-Surgery|This analysis includes participants who completed the study and used a smartphone application to record study outcome measures following surgery.|||percentage of participants|||Number
2564844|NCT02604550|Secondary|Time to Straight Less Raise|The amount of time (in hours) it takes for participants to have the ability to perform a straight leg raise post-surgery.|Post-Surgery (up to 6 days)|This analysis includes participants who completed the study and used a smartphone application to record when they were able to perform a straight leg raise following surgery.|||hours||Standard Deviation|Mean
2564845|NCT02604550|Secondary|Patient-Reported Itching|Total occurrences of patient-reported itching post-surgery.|Post-Surgery (up to 6 days)|This analysis includes participants who completed the study and used a smartphone application for 6 days post-operatively to record every time they experienced itching.|||occurrence of itching|||Number
2564846|NCT02604550|Secondary|Patient-Reported Sedation|Total occurrences of patient-reported feelings of sedation post-surgery.|Post-Surgery (up to 6 days)|This analysis includes participants who completed the study and used a smartphone application for 6 days post-operatively to record every time they experienced feelings of sedation.|||occurrence of sedation|||Number
2564847|NCT02604550|Secondary|Patient-Reported Constipation|Total occurrences of patient-reported constipation post-surgery.|Post-Surgery (up to 6 days)|This analysis includes participants completing the study and who used a smartphone application for 6 days post-operatively to record every time they experienced constipation.|||occurrence of constipation|||Number
2564848|NCT02604550|Secondary|Patient-Reported Vomiting|Total occurrences of patient-reported vomiting post-surgery.|Post-Surgery (up to 6 days)|This analysis includes participants who completed the study and used a smartphone application for 6 days post-operatively to record every time they experienced vomiting.|||occurrence of vomiting|||Number
2564849|NCT02604550|Secondary|Patient-Reported Nausea|Total occurrences of patient-reported nausea post-surgery.|Post-Surgery (up to 6 days)|This analysis includes participants completing the study who used a smartphone application for 6 days post-operatively to record every time they experienced nausea.|||occurrence of nausea|||Number
2564850|NCT02604550|Secondary|Total Hours of Sleep|The total hours of sleep first postoperative night, between 0 to 12 hours.|First Postoperative Night (up to 12 hours)|This analysis includes participants who completed the study and used a smartphone application to record their number of hours of sleep during the night following their surgery.|||hours||Standard Deviation|Mean
2564852|NCT02604550|Primary|Pain Score|Pain scores range from 0 (no pain at all) to 10 (worst imaginable pain). Pain level was reported at the time of discharge from the surgery recovery room, the evening of the day of surgery, and then three times per day for six days post-surgery. During the six days after surgery, the morning assessment asked about typical knee pain levels overnight, the afternoon assessment asked about knee pain levels since the morning entry, and the evening assessment asked about knee pain levels since the afternoon entry.|Post-surgery (day of surgery to 6 days post-surgery)|This analysis includes participants who completed the study and used a smartphone application to record pain level for 6 days post-surgery.|||units on a scale||Standard Deviation|Mean
2564853|NCT02604433|Secondary|Participants With Pre-Existing and/or Treatment-Emergent Antidrug Antibodies (ADA) (Data Cut-off Date: 11 May 2018)|"Number of participants with positive ADA prior to taking study drug and/or during study. A participant was counted as treatment-emergent if there was a positive post-baseline sample while the baseline sample was ADA negative, or there was a positive post-baseline sample with a titer ≥ 4-fold of the baseline titer while the baseline sample was ADA positive. A participant was counted as preexisting if the baseline sample was ADA positive and the participant was not qualified for treatment-emergent."|Timeframe: predose Day 1, Days 22, 64, 106, 148, 232, 316|Safety population of participants with ADA samples collected|||Participants|||Count of Participants
2564854|NCT02604433|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE) (Data Cut-off Date: 11 May 2018)|An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. A TEAE includes AEs between the first dose date of either study drug and 90 days after the last dose of study drug. A serious AE is any AE occurring at any dose that - Results in death - Is life-threatening - Requires or prolongs existing inpatient hospitalization - Results in persistent or significant disability/incapacity - Is a congenital anomaly/birth defect - Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03): - Grade 1 = Mild - Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention) - Grade 3 = Severe (limitation in activity; medical intervention required) - Grade 4 = Life-threatening - Grade 5 = Death|Day 1 up to 97 weeks (maximum treatment as of data cut-off date)|Safety population Included all randomized participants who received at least 1 dose of treatment.|||Participants|||Count of Participants
2564855|NCT02604433|Secondary|Pharmacokinetic (PK) Parameters: Bayesian Estimate of Area Under the Concentration-Time Curve at Steady State for the Starting Dose (AUCss) (Data Cut-off Date: 11 May 2018)||Blood serum samples taken pre-dose on Days 1, 22, 64, 85, 106, 127, 169, 211, 253, 295, 337. Blood serum samples also taken on Days 135 and 142 (Days 8 + 15 after Dose 6)|Pharmacokinetic (PK) population Included all participants who received at least 1 dose of luspatercept and had measurable luspatercept serum concentrations.|||day*μg/mL||Geometric Coefficient of Variation|Geometric Mean
2564856|NCT02604433|Secondary|Pharmacokinetic (PK) Parameters: Bayesian Estimate of Maximum Concentration at Steady State for the Starting Dose (Cmax,ss) (Data Cut-off Date: 11 May 2018)||Blood serum samples taken pre-dose on Days 1, 22, 64, 85, 106, 127, 169, 211, 253, 295, 337. Blood serum samples also taken on Days 135 and 142 (Days 8 + 15 after Dose 6)|Pharmacokinetic (PK) population Included all participants who received at least 1 dose of luspatercept and had measurable luspatercept serum concentrations.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2564857|NCT02604433|Secondary|Pharmacokinetic (PK) Parameters: Bayesian Estimate of Maximum Concentration for the Starting Dose (Cmax) (Data Cut-off Date: 11 May 2018)||Blood serum samples taken pre-dose on Days 1, 22, 64, 85, 106, 127, 169, 211, 253, 295, 337. Blood serum samples also taken on Days 135 and 142 (Days 8 + 15 after Dose 6)|Pharmacokinetic (PK) population Included all participants who received at least 1 dose of luspatercept and had measurable luspatercept serum concentrations.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2564858|NCT02604433|Secondary|Pharmacokinetic (PK) Parameters: Bayesian Estimate of Time to Reach Maximum Concentration (Tmax) (Data Cut-off Date: 11 May 2018)||Blood serum samples taken pre-dose on Days 1, 22, 64, 85, 106, 127, 169, 211, 253, 295, 337. Blood serum samples also taken on Days 135 and 142 (Days 8 + 15 after Dose 6)|Pharmacokinetic (PK) population Included all participants who received at least 1 dose of luspatercept and had measurable luspatercept serum concentrations.|||days||Full Range|Median
2564859|NCT02604433|Secondary|Pharmacokinetic (PK) Parameters: Bayesian Estimate of Elimination Half-life (t1/2) (Data Cut-off Date: 11 May 2018)||Blood serum samples taken pre-dose on Days 1, 22, 64, 85, 106, 127, 169, 211, 253, 295, 337. Blood serum samples also taken on Days 135 and 142 (Days 8 + 15 after Dose 6)|Pharmacokinetic (PK) population Included all participants who received at least 1 dose of luspatercept and had measurable luspatercept serum concentrations.|||days||Geometric Coefficient of Variation|Geometric Mean
2564860|NCT02604433|Secondary|Pharmacokinetic (PK) Parameters: Bayesian Estimate of Apparent Volume of Distribution of the Central Compartment (V1/F) (Data Cut-off Date: 11 May 2018)||Blood serum samples taken pre-dose on Days 1, 22, 64, 85, 106, 127, 169, 211, 253, 295, 337. Blood serum samples also taken on Days 135 and 142 (Days 8 + 15 after Dose 6)|Pharmacokinetic (PK) population Included all participants who received at least 1 dose of luspatercept and had measurable luspatercept serum concentrations.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2564861|NCT02604433|Secondary|Pharmacokinetic (PK) Parameters: Bayesian Estimate of Apparent Clearance (CL/F) (Data Cut-off Date: 11 May 2018)||Blood serum samples taken pre-dose on Days 1, 22, 64, 85, 106, 127, 169, 211, 253, 295, 337. Blood serum samples also taken on Days 135 and 142 (Days 8 + 15 after Dose 6)|Pharmacokinetic (PK) population Included all participants who received at least 1 dose of luspatercept and had measurable luspatercept serum concentrations.|||L/day||Geometric Coefficient of Variation|Geometric Mean
2564886|NCT02604342|Secondary|Percentage of Participants With Adverse Events (AEs)|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline through study end (up to 33 months)|Safety (SAF) population included all participants who received at least one dose of any study drug.|||Percentage of Participants|||Number
2564992|NCT02603419|Secondary|Expansion Phase: Terminal Elimination Half-Life (t1/2) of Avelumab After Single and Multiple Dose|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.|pre-dose and 1 hour post-dose on Day 1 of Cycles 1, 2 and 3|Data for this outcome measure was not collected due to early termination of study.||||||
2564862|NCT02604433|Secondary|Post-Baseline Transfusion Event Frequency (Data Cut-off Date: 11 May 2018)|The number of transfusion events were evaluated, as these relate directly to hours or days devoted to receiving RBC transfusions that can impact patients' quality of life. For the definition of transfusion events, if multiple transfusions happen on the same date, they are counted as one event; if multiple transfusions happen on two consecutive dates, they are counted as one event; if multiple transfusions happen on three consecutive dates, they are counted as two events. Events are counted while on while on treatment inclusive of 3 weeks after the last treatment.|Transfusion data is collected continuously at week (wk) -24 (12 weeks pre ICF) up to 9 wks post last dose. Efficacy cutoff = defined as: death, study discontinuation, last dose+20, 11 May 18; median exposure is 64.1 wks (Q1, Q3: 52.5,70.0; Min, Max: 3,97)|Intent to treat population of participants who had post-baseline infusions|||transfusions||Standard Deviation|Mean
2564863|NCT02604433|Secondary|Time to Erythroid Response in Participants With ≥ 33% Reduction and ≥ 50% Reduction in RBC Transfusion Burden (Data Cut-off Date: 11 May 2018)|Time to erythroid response was defined as the time from first dose of the study drug to first erythroid response. This is reported for participants with a ≥ 33% reduction from baseline in RBC transfusion burden (with a reduction of at least 2 units) for any 12-week interval., as well as participants with a ≥ 50% reduction from baseline in RBC transfusion burden (with a reduction of at least 2 units) for any 12-week interval.|Transfusion data is collected continuously at week (wk) -24 (12 weeks pre ICF) up to 9 wks post last dose. Efficacy cutoff = defined as: death, study discontinuation, last dose+20, 11 May 18; median exposure is 64.1 wks (Q1, Q3: 52.5,70.0; Min, Max: 3,97)|Intent to treat population|||days||Standard Deviation|Mean
2564864|NCT02604433|Secondary|Kaplan-Meier Estimates for Duration of Transfusion Independence in Participants Who Were Transfusion Independent For ≥ 8 Weeks (Data Cut-off Date: 11 May 2018)|"Transfusion independence was defined as the absence of any transfusion during any consecutive rolling 8-week time interval within the treatment period, ie, Days 1 to 56, Days 2 to 57 and so on. Participants discontinued from double-blind treatment for lack of therapeutic effect or with less than 56 days of assessment during the double-blind treatment period were counted as nonresponders."|Transfusion data is collected continuously at week (wk) -24 (12 weeks pre ICF) up to 9 wks post last dose. Efficacy cutoff = defined as: death, study discontinuation, last dose+20, 11 May 18; median exposure is 64.1 wks (Q1, Q3: 52.5,70.0; Min, Max: 3,97)|ITT population of participants who were transfusion independent for >=8 weeks|||days||95% Confidence Interval|Median
2564865|NCT02604433|Secondary|Mean Duration of Reduction in Transfusion Burden In Participants With a >= 33% Reduction and >=50% Reduction in Red Blood Cell (RBC) Transfusion Burden During Any Rolling 12-week Interval Up to the Efficacy Cutoff Date (11 May 2018)|The duration of response was defined as Last Day of Response - First Day of Response + 1. For participants who continued to respond at the efficacy cutoff, the end day of the response was censored at the date of efficacy cutoff and the duration of response was calculated as date of efficacy cutoff - first day of response + 1 day. The efficacy cutoff date was defined as the minimum date among death date, study discontinuation date, last dose date + 20, and 11 May 2018. The response of transfusion burden reduction was assessed based on rolling method.|Transfusion data is collected continuously at week (wk) -24 (12 weeks pre ICF) up to 9 wks post last dose. Efficacy cutoff = defined as: death, study discontinuation, last dose+20, 11 May 18; median exposure is 64.1 wks (Q1, Q3: 52.5,70.0; Min, Max: 3,97)|Intent to treat population|||days||Standard Deviation|Mean
2564866|NCT02604433|Secondary|Percentage Of Participants Who Were Transfusion Independent For ≥ 8 Weeks During Treatment (Data Cut-off Date: 11 May 2018)|"Transfusion independence was defined as the absence of any transfusion during any consecutive rolling 8-week time interval within the treatment period, i.e, Days 1 to 56, Days 2 to 57 and so on. Participants discontinued from double-blind treatment for lack of therapeutic effect or with less than 56 days of assessment during the double-blind treatment period were counted as nonresponders. Transfusion records were collected up to a minimum of (death date, or study discontinuation date, or last dose date + 20 days, or 11 May 2018) were used for the analysis."|Transfusion data is collected continuously at week (wk) -24 (12 weeks pre ICF) up to 9 wks post last dose. Efficacy cutoff = defined as: death, study discontinuation, last dose+20, 11 May 18; median exposure is 64.1 wks (Q1, Q3: 52.5,70.0; Min, Max: 3,97)|Intent to treat population|||percentage of participants|||Number
2564867|NCT02604433|Secondary|Number of Days in Higher Care Hospital Units; [Healthcare Resource Utilization (HRU)] (Data Cut-off Date: 11 May 2018)|Types of hospitals units considered to be 'higher care' are - Intensive Care Unit - Coronary Care Unit|HRU data is collected continuously from Week-12 (informed consent) up to 9 weeks post last dose. Up to data cutoff date of 11 May 2018 (48 weeks post last participant enrolled day 1), median exposure is 64.1 weeks (Q1,Q3:52.5,70.0; Min, Max: 3,97)|Intent to treat population of study participants who spent time in higher care hospital units|||days||Standard Deviation|Mean
2564868|NCT02604433|Secondary|Percentage of Participants Who Utilized Healthcare Resources During Treatment [Healthcare Resource Utilization (HRU)] (Data Cut-off Date: 11 May 2018)|Percentage of participants who had a doctor office visit (non-study scheduled), or emergency room visit, or a hospitalization after signing informed consent.|HRU data is collected continuously from Week-12 (informed consent) up to 9 weeks post last dose. Up to data cutoff date of 11 May 2018 (48 weeks post last participant enrolled day 1), median exposure is 64.1 weeks (Q1,Q3:52.5,70.0; Min, Max: 3,97)|Intent to Treat Population|||percentage of participants|||Number
2564869|NCT02604433|Secondary|Baseline Values and Mean Change From Baseline in the 36-item Short Form Health Survey (SF-36) Questionnaire Physical Component Summary at Weeks 24 and 48 (Data Cut-off Date: 11 May 2018)|The SF-36 is a generic, self-administered instrument consisting of 8 multi-item scales that assess 8 health domains. The Physical Component Summary is one of two summary scales that summarize information from the 8 health scales. This information is also converted to norm-based scores using a T-score transformation, with a mean of 50 and a standard deviation (SD) of 10. Higher norm-based T-scores indicate better heath/QoL, based on data from a nationally representative sample of adults from the US. The range of possible T-scores for the Physical Component Summary is 5.02 - 79.78 and the minimally important differences between readings is considered 2.0. The completion of the SF-36 for a given visit was defined as ≥ 50% of all items being answered (ie, ≥ 18 items of the 36 items). Positive change from baseline values indicate improvement.|Baseline: 4 weeks prior to Day 1; Treatment: Weeks 24 and 48|HRQoL evaluable population are participants with an evaluable SF-36 questionnaire at screening visit and at least one post-screening visit for the ITT population.|||T-score||Standard Deviation|Mean
2564870|NCT02604433|Secondary|Baseline Values and Mean Change From Baseline in the 36-item Short Form Health Survey (SF-36) Questionnaire General Health Domain at Weeks 24 and 48 (Data Cut-off Date: 11 May 2018)|The SF-36 is a generic, self-administered instrument consisting of 8 multi-item scales that assess 8 health domains. Survey items 1, 11a-11d comprise the General Health domain which is reported here. The raw score for each health domain is transformed into a 0 (worst) to 100 (best) domain score. The 0-100 scale score for each health domain is further converted to norm-based scores using a T-score transformation, with a mean of 50 and a standard deviation (SD) of 10. Higher norm-based T-scores indicate better heath/QoL, based on data from a nationally representative sample of adults from the US. The range of possible T-scores for the General Health domain is 18.95 - 66.50 and the minimally important differences between readings is considered 2.0. The completion of the SF-36 for a given visit was defined as ≥ 50% of all items being answered (ie, ≥ 18 items of the 36 items). Positive change from baseline values indicate improvement.|Baseline: 4 weeks prior to Day 1; Treatment: Weeks 24 and 48|HRQoL evaluable population are participants with an evaluable SF-36 questionnaire at screening visit and at least one post-screening visit for the ITT population.|||T-score||Standard Deviation|Mean
2564871|NCT02604433|Secondary|Baseline Values and Mean Change From Baseline in the 36-item Short Form Health Survey (SF-36) Questionnaire Physical Functioning Domain at Weeks 24 and 48 (Data Cut-off Date: 11 May 2018)|The SF-36 is a generic, self-administered instrument consisting of 8 multi-item scales that assess 8 health domains. Survey items 3a-3j comprise the Physical Functioning domain which is reported here. The raw score for each health domain is transformed into a 0 (worst) to 100 (best) domain score. The 0-100 scale score for each health domain is further converted to normbased scores using a T-score transformation, with a mean of 50 and a standard deviation (SD) of 10. Higher norm-based T-scores indicate better heath/QoL, based on data from a nationally representative sample of adults from the US. The range of possible T-scores for the Physical Functioning domain is 19.26 - 57.54 and the minimally important differences between readings is considered 3.0. The completion of the SF-36 for a given visit was defined as ≥ 50% of all items being answered (ie, ≥ 18 items of the 36 items). Positive change from baseline values indicate improvement.|Baseline: 4 weeks prior to Day 1; Treatment: Weeks 24 and 48|HRQoL evaluable population are participants with an evaluable SF-36 questionnaire at screening visit and at least one post-screening visit for the ITT population.|||T-score||Standard Deviation|Mean
2564872|NCT02604433|Secondary|Baseline Values and Mean Change From Baseline in the Transfusion-dependent Quality of Life (TranQol) Questionnaire Physical Health Domain at Weeks 24 and 48 (Data Cut-off Date: 11 May 2018)|The TranQol is a disease-specific, self-administered, well-validated health-related quality of life tool developed for beta-thalassemia patients. The adult self-report version used in this study, includes 10 questions concerning physical assessed on a 5-point response scale. Scores are calculated according to author's guidelines and scoring rules. The Physical Health Domain ranges from 0 (worst) to 100 (best). The TranQoL was considered completed at a given visit when ≥ 75% of all items were answered (ie, ≥ 27 items of the 36 items or a nonmissing total score). Positive change from baseline values indicate improvement.|Baseline: 4 weeks prior to Day 1; Treatment: Weeks 24 and 48|HRQoL evaluable population are participants with an evaluabe TranQoL questionnaire at screening visit and at least one post-screening visit for the ITT population.|||units on a scale||Standard Deviation|Mean
2564873|NCT02604433|Secondary|Baseline Values and Mean Change From Baseline in the Transfusion-dependent Quality of Life (TranQol) Questionnaire Total Score at Weeks 24 and 48|The TranQol is a disease-specific, self-administered, well-validated health-related quality of life tool developed for beta-thalassemia patients. The adult self-report version used in this study, includes 36 questions assessed on a 5-point response, that are grouped into 5 domains (Physical Health, Emotional Health, Sexual Health, Family Functioning, School/Career Functioning). Scores are calculated according to author's guidelines and scoring rules. The total score ranges from 0 (worst) to 100 (best). The TranQoL was considered completed at a given visit when ≥ 75% of all items were answered (ie, ≥ 27 items of the 36 items or a nonmissing total score). Positive change from baseline values indicate improvement.|Baseline: 4 weeks prior to Day 1; Treatment: Weeks 24 and 48|HRQoL evaluable population are participants with an evaluable TranQoL questionnaire at screening visit and at least one post-screening visit for the Intent to Treat population.|||units on a scale||Standard Deviation|Mean
2564874|NCT02604433|Secondary|Baseline Values and Mean Change From Baseline In Myocardial Iron By T2* Magnetic Resonance Imaging (MRI) at Week 48 (Data Cut-off Date: 11 May 2018)|MRI parameter T2* (Unit: ms) is considered as the most reliable way to assess cardiac iron overload and heart failure (HF) risk compared to other methods in Beta-Thalassemia patients, clinical management being nowadays based on it (e.g. T2*<6ms: high HF risk)|Baseline: Day 1; Treatment: Week 48|Intent to Treat Population of participants with data at the timepoints.|||ms||Standard Deviation|Mean
2564875|NCT02604433|Secondary|Baseline Values and Mean Change From Baseline In Total Hip And Lumbar Spine Bone Mineral Density (BMD) At Week 48 By Dual Energy X-Ray Absorptiometry (DXA) (Data Cut-off Date: 11 May 2018)|For BMD, the lumbar spine and total hip were measured at baseline and 48 weeks by dual energy x-ray absorptiometry (DXA). Baseline was defined as the last value on or before the first dose of study drug is administered; if multiple values are present for the same date, the average of these values was used. If during the 48 week double-blinded treatment period, a participant has only one assessment, it is counted as 'Week 48' visit; if a participant has multiple assessments, the last one is used as 'Week 48' visit. The analysis was done on the population that had at least 2 measurements.|Baseline: Day 1; Treatment: Week 48|Intent to treat population of participants with data at the relevant time points.|||gm/cm^2||Standard Deviation|Mean
2564876|NCT02604433|Secondary|Baseline Values and Mean Change From Baseline At Week 48 In Mean Serum Ferritin (Data Cut-off Date: 11 May 2018)|For each participant, the baseline mean serum ferritin level was calculated during the 12 weeks prior to first study drug administration. The postbaseline mean serum ferritin level was calculated during the last 12 weeks of the 48-week double-blind Treatment Period or last 12 weeks of study treatment, if discontinued early. The change was calculated as the difference of post baseline mean serum ferritin level and baseline mean serum ferritin level.|Baseline: Day -83 to Day 1; Treatment: Week 37 to Week 48|Intent to treat population of participants with data at the relevant time points.|||μg/L||Standard Deviation|Mean
2565243|NCT02600715|Secondary|Postoperative Voiding Trial Results|Distribution of patients with postoperative volume in ml of post-void residual urine obtained via catheter greater than 200ml.|Postoperative (before leaving the clinic, within 3 hours of the end of the BoNT procedure)||||Participants|||Count of Participants
2564877|NCT02604433|Secondary|Baseline Values and Mean Change From Baseline At Week 48 In Mean Daily Dose Of Iron Chelation Therapies (ICT) Deferasirox, Deferiprone and Deferoxamine Mesilate/Deferoxamine (Data Cut-off Date: 11 May 2018)|This outcome tests the hypothesis that reducing the transfusion burden will likely reduce ICT daily dosage requirements, which will provide a number of benefits to the participants. The baseline mean daily dose was calculated using the ICT dosage during the 12 weeks prior to first study drug administration and the postbaseline mean daily dose was calculated during the last 12 weeks of the 48-week double-blind Treatment Period or the last 12 weeks of the study treatment for early discontinued participants. DM/D = Deferoxamine Mesilate / Deferoxamine|Baseline: Day -83 to Day 1; Treatment: Week 37 to Week 48|Intent to Treat Population. Data are provided for participants who did not change ICT drug from baseline to post baseline and for whom only 1 ICT had been used.|||mg||Standard Deviation|Mean
2564878|NCT02604433|Secondary|Baseline Values and Mean Change From Baseline At Week 48 In Derived Liver Iron Concentration (LIC) By Magnetic Resonance Imaging (MRI) (Data Cut-off Date: 11 May 2018)|In β-thalassemia adult patients who are transfused, iron overload occurs mainly as a result of accumulation of iron from transfusions and, to a lesser extent, increased intestinal absorption of iron due to hepcidin suppression. Baseline was defined as the last value on or before the first dose of study drug was administered; if multiple values were present for the same date, the average of these values was used. If a participant had 1 postbaseline assessment, it was used as the Week 48 value. If a participant had multiple postbaseline assessments, the last one was used as the Week 48 value. The value of LIC was either the value collected from the electronic case report form or the value derived from the T2*, R2*, or R2 parameter, depending on which techniques and software were used for magnetic resonance imaging LIC acquisition. Participants with an LIC value > 43 mg/g were not included in the analysis.|Baseline: Week -12 to Day -1; Treatment: Week 48|Intent to Treat Population of participants with data at the timepoints.|||mg/g dry weight||Standard Deviation|Mean
2564879|NCT02604433|Secondary|Baseline Values and Mean Change From Baseline in Transfusion Burden (RBC Units) to the Fixed Week 13 to Week 24 Interval (Data Cut-off Date: 11 May 2018)|Baseline was defined as the total number of RBC units transfused during the 12-week interval on or prior to Dose 1 Day 1. This is compared to the total number of RBC units transfused during the 12-week interval from treatment weeks 13-24.|Baseline: Day -83 to Day 1; Treatment: Weeks 13 to Week 24|Intent to Treat Population|||RBC units||Standard Deviation|Mean
2564880|NCT02604433|Secondary|Percentage Of Participants Who Achieve >=50% Reduction From Baseline in Transfusion Burden From Week 37 to Week 48 (Data Cut-off Date: 11 May 2018)|This hematological improvement outcome was defined as the percentage of participants who achieved a red blood cell (RBC) transfusion burden reduction from baseline ≥ 50% with a reduction of at least 2 units during Week 37 to Week 48 compared to the 12-week interval on or prior to Dose 1 Day 1. Transfusion records collected up to a minimum of (death date, study discontinuation date, last dose date + 20 days or 11 May 2018) were used for the analysis.|Baseline: Day -83 to Day 1; Treatment: Week 37 to Week 48|Intent to Treat Population|||percentage of participants|||Number
2564881|NCT02604433|Secondary|Percentage Of Participants Who Achieve >=50% Reduction From Baseline in Transfusion Burden From Week 13 to Week 24 (Data Cut-off Date: 11 May 2018)|This hematological improvement outcome was defined as the percentage of participants who achieved a red blood cell (RBC) transfusion burden reduction from baseline ≥ 50% with a reduction of at least 2 units during Weeks 13 - 24 compared to the 12-week interval on or prior to Dose 1 Day 1. Transfusion records collected up to a minimum of (death date, study discontinuation date, last dose date + 20 days or 11 May 2018) were used for the analysis.|Baseline: Day -83 to Day 1; Treatment: Weeks 13 to Week 24|Intent to Treat Population|||percentage of participants|||Number
2564882|NCT02604433|Secondary|Percentage Of Participants Who Achieve >=33% Reduction From Baseline in Transfusion Burden From Week 37 to Week 48 (Data Cut-off Date: 11 May 2018)|This hematological improvement outcome was defined as the percentage of participants who achieved a red blood cell (RBC) transfusion burden reduction from baseline ≥ 33% with a reduction of at least 2 units during Weeks 37 - 48 compared to the 12-week interval on or prior to Dose 1 Day 1. Transfusion records collected up to a minimum of (death date, study discontinuation date, last dose date + 20 days or 11 May 2018) were used for the analysis.|Baseline: Day -83 to Day 1; Treatment: Weeks 37 to Week 48|Intent to Treat Population|||percentage of participants|||Number
2564883|NCT02604433|Primary|Percentage of Participants Who Achieved Erythroid Response From Week 13 to Week 24 (Data Cut-off Date: 11 May 2018)|Erythroid Response was defined as red blood cell (RBC) transfusion burden reduction from baseline ≥ 33% with a reduction of at least 2 units during Week 13 - 24 compared to the 12-week interval on or prior to Dose 1 Day 1. Transfusion records collected up to a minimum of (death date, study discontinuation date, last dose date + 20 days or 11 May 2018) were used for the analysis.|Baseline: Day -83 to Day 1; Treatment: Weeks 13 to Week 24|Intent to Treat Population|||percentage of participants|||Number
2564884|NCT02604407|Secondary|Clinical Global Impression of Improvement (CGI-I) Score at Visit 6 (Week 4)|CGI scales permit a global evaluation of the participant's severity and improvement over time. CGI-I was performed to rate the severity of a participant's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Visit 6 (Week 4)|Full-analysis set (FAS) consisted of all participants in the safety set who had at least 1 postdose baseline primary efficacy assessment (ADHD-RS with prompt total score) on treatment with number of participants evaluable for this outcome.|||Units on a scale||Standard Deviation|Mean
2564885|NCT02604407|Primary|Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4)|The ADHD-RS was developed to measure the behaviors of children with Attention deficit hyperactivity disorder (ADHD). The adult ADHD-RS with prompts consists of 18 items designated to reflect current symptomatology of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), with the total score for the rating scale ranging from 0 to 54. Higher score = more severe symptoms.The scale is subdivided into 2 subscales of 9 symptoms each: hyperactivity/impulsivity and inattentiveness. Adult prompts are included with the ADHD-RS to create a semistructured measurement that allows the clinician to probe the extent, frequency, breadth, severity, and consequences of these symptoms to ascertain impairment in an adult population.|Baseline, Visit 6 (Week 4)|Full Analysis Set (FAS) consisted of all participants in the safety set who had at least 1 post dose baseline primary efficacy assessment (ADHD-RS with prompt total score) on treatment.|||Units on a scale||Standard Deviation|Mean
2564887|NCT02604342|Secondary|TTD in Composite of Three Symptoms (Cough, Dyspnea, and Chest Pain) Using EORTC QLQ-LC13 Score for ITT Population|TTD for a composite of three symptoms (cough, dyspnea, chest pain) in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for any component of the composite of the three following symptoms [cough, dyspnea [multi-item subscales QLQ-LC13] and chest pain]) as measured by the EORTC QLQ-LC13.|Baseline through study end (up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||months||95% Confidence Interval|Median
2564888|NCT02604342|Secondary|TTD in Composite of Three Symptoms (Cough, Dyspnea, and Chest Pain) Using EORTC QLQ-LC13 Score for C-ITT Population|TTD for a composite of three symptoms (cough, dyspnea, chest pain) in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for any component of the composite of the three following symptoms [cough, dyspnea [multi-item subscales QLQ-LC13] and chest pain]) as measured by the EORTC QLQ-LC13.|Baseline through study end (up to 33 months)|C-ITT included participants in ITT population with CNS metastasis at baseline (as per IRC assessment).|||months||95% Confidence Interval|Median
2564889|NCT02604342|Secondary|Time to Deterioration (TTD) in Lung Cancer Symptoms Using EORTC QLQ-LC30 Score for C-ITT Population|TTD in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for symptoms domains (or decrease for functioning domains from baseline for cough, dyspnea [single item and multi-item scales] chest pain [single item], pain in arm/shoulder and fatigue as measured by the EORTC QLQ-C30.|Baseline through study end (up to 33 months)|C-ITT included participants in ITT population with CNS metastasis at baseline (as per IRC assessment).|||months||95% Confidence Interval|Median
2564890|NCT02604342|Secondary|Time to Deterioration (TTD) in Lung Cancer Symptoms Using EORTC QLQ-LC30 Score for ITT Population|TTD in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for symptoms domains (or decrease for functioning domains from baseline for cough, dyspnea [single item and multi-item scales] chest pain [single item], pain in arm/shoulder and fatigue as measured by the EORTC QLQ-C30.|Baseline through study end (up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||months||95% Confidence Interval|Median
2564891|NCT02604342|Secondary|Time to Deterioration (TTD) in Lung Cancer Symptoms Using EORTC QLQ-LC13 Score for C-ITT Population|TTD in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for symptoms domains (or decrease for functioning domains from baseline for cough, dyspnea [single item and multi-item scales] chest pain [single item], pain in arm/shoulder and fatigue as measured by the EORTC QLQ-LC13.|Baseline through study end (up to 33 months)|C-ITT included participants in ITT population with CNS metastasis at baseline (as per IRC assessment). Number analyzed indicates number of participants evaluated for specified categories.|||months||95% Confidence Interval|Median
2564892|NCT02604342|Secondary|Time to Deterioration (TTD) in Lung Cancer Symptoms Using EORTC QLQ-LC13 Score for ITT Population|TTD in the overall population is defined as time from randomization to the earliest time with a ≥10-point increase from baseline for symptoms domains (or decrease for functioning domains from baseline for cough, dyspnea [single item and multi-item scales] chest pain [single item], pain in arm/shoulder and fatigue as measured by the EORTC QLQ-LC13.|Baseline through study end (up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified categories.|||months||95% Confidence Interval|Median
2564893|NCT02604342|Secondary|Compliance of European Quality of Life (EuroQoL) 5 Dimension 5 Levels (EQ-5D-5L) Questionnaire Over Time|Percentage of participants who filled out an ED-5D-5L questionnaire at a visit. EQ-5D-5L: A generic preference-based health utility measure that provides a single index value for health status. The instrument consists of two parts. The first part, health-state classification, contains five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.|Baseline through Week 60|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||percentage of participants|||Number
2564894|NCT02604342|Secondary|Compliance of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer-13 (EORTC QLQ-LC13) Over Time|Percentage of participants who filled out an EORTC QLQ-LC13 questionnaire at a visit. The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis.|Baseline through Week 138|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||percentage of participants|||Number
2564895|NCT02604342|Secondary|Compliance of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Over Time|Percentage of participants who filled out an EORTC QLQ-C30 questionnaire at a visit. The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden.|Baseline through Week 138|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||percentage of participants|||Number
2564896|NCT02604342|Secondary|Plasma Concentration of Alectinib Metabolite||Predose (2 hours) at Baseline, Week 3 and Week 6|The PK Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2564897|NCT02604342|Secondary|Plasma Concentration of Alectinib||Predose (2 hours) at Baseline, Week 3 and Week 6|The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2564931|NCT02604199|Secondary|Pharmacokinetics of ARC-520: Terminal Elimination Rate Constant (Kel)||Through 48 hours post-dosing on Day 1 and Day 85|Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.||||||
2564898|NCT02604342|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from randomization to death from any cause. OS was confounded by cross-over of participants to the alectinib arm.|Randomization to death from any cause, through study end (up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||months||95% Confidence Interval|Median
2564899|NCT02604342|Secondary|Duration of Response for Lesions in the CNS (C-DOR) Using RECIST Version 1.1 as Assessed by IRC|DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. C-DOR was defined in a similar way for lesions in the CNS, taking into account all lesions in the body. DOR was evaluated for participants who had a BOR of CR or PR.|From the first documented CR or PR to the first documented disease progression, death, or study end (up to 33 months)|C-ITT included participants in ITT population with CNS metastasis at baseline (as per IRC assessment). Number analyzed indicates number of participants with a BOR of CR or PR.|||months||95% Confidence Interval|Median
2564900|NCT02604342|Secondary|Percentage of Participants With ORR in C-ITT Population Using RECIST Version 1.1 as Assessed by IRC|ORR was defined as the percentage of participants who attained CR or PR. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|Baseline through study end (up to 33 months)|C-ITT included participants in ITT population with CNS metastasis at baseline (as per IRC assessment).|||percentage of participants|||Number
2564901|NCT02604342|Secondary|Percentage of Participants With Disease Control in C-ITT Population Using RECIST Version 1.1 as Assessed by IRC|Disease Control Rate (DCR) was defined as the percentage of participants who attained CR, PR, or stable disease (SD) of at least 5 weeks. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters, SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters since the treatment started.|From first documented CR, PR, or SD lasting at least 5 weeks through study end (up to 33 months)|C-ITT included participants in ITT population with CNS metastasis at baseline (as per IRC assessment).|||percentage of participants|||Number
2564902|NCT02604342|Secondary|Time to CNS Progression in C-ITT Population Using RECIST Version 1.1 as Assessed by IRC|"Time to CNS progression was defined as the time from randomization until radiographic evidence of CNS progression. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.~This outcome measure assessment was part of the primary analysis and was not repeated during final analysis."|Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)|C-ITT included participants in ITT population with CNS metastasis at baseline (as per IRC assessment).|||months||95% Confidence Interval|Median
2564903|NCT02604342|Secondary|PFS in C-ITT Population Using RECIST Version 1.1 as Assessed by Investigator and IRC|"PFS was defined as the time from randomization to the first documented disease progression, as determined using RECIST v1.1, or death from any cause, whichever occurred first. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.~This outcome measure assessment was part of the primary analysis and was not repeated during final analysis."|Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)|Intent-to-treat population with CNS metastasis (C-ITT) included participants in ITT population with CNS metastasis at baseline (as per IRC assessment).|||months||95% Confidence Interval|Median
2564904|NCT02604342|Secondary|Duration of Response (DOR) Using RECIST Version 1.1 as Assessed by Investigator and IRC|"DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.~The IRC assessment was part of the primary analysis and was not repeated during final analysis."|From the first documented CR or PR to the first documented disease progression, death, or study end (up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants with a BOR of CR or PR.|||months||95% Confidence Interval|Median
2564905|NCT02604342|Secondary|Percentage of Participants With Disease Control Using RECIST Version 1.1 as Assessed by Investigator and IRC|"Disease control rate (DCR) was defined as the percentage of participants who attained CR, PR, or stable disease (SD) of at least 5 weeks. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters, SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters since the treatment started.~The IRC assessment was part of the primary analysis and was not repeated during final analysis."|Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||percentage of participants|||Number
2564906|NCT02604342|Secondary|Percentage of Participants With Objective Response of CR or PR Using RECIST Version 1.1 as Assessed by Investigator and IRC|"ORR was defined as the percentage of participants who attained CR or PR. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.~The IRC assessment was part of the primary analysis and was not repeated during final analysis."|Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||percentage of participants|||Number
2564907|NCT02604342|Secondary|PFS Using RECIST Version 1.1 as Assessed by IRC|"PFS was defined as the time from randomization to the first documented disease progression, as determined using RECIST v1.1, or death from any cause, whichever occurred first. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.~This outcome measure was assessed as part of the primary analysis and was not repeated during final analysis."|Approximately 15 months (Tumor assessments at baseline, every 6 weeks until progressive disease (PD), death or withdrawal from study prior to PD)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||months||95% Confidence Interval|Median
2564908|NCT02604342|Secondary|Percentage of Participants With CNS Objective Response Rate (ORR) With Measurable CNS Metastases at Baseline Using RECIST Version 1.1 as Assessed By IRC|Overall response rate in subjects with confirmed CNS response (C-ORR) was defined as the percentage of subjects who attained Complete Response (CR) or Partial Response (PR) for lesions in the CNS. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|Baseline through study end (up to 33 months)|ITT population with measurable CNS metastasis (mc-ITT) included all participants in ITT population with measurable CNS metastasis at baseline (as per IRC).|||percentage of participants|||Number
2564909|NCT02604342|Primary|Progression-Free Survival (PFS) Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Investigator|PFS was defined as the time from randomization to the first documented disease progression, as determined using RECIST v1.1, or death from any cause, whichever occurred first. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.|Randomization to first documented disease progression, death from any cause, or study end (up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug.|||months||95% Confidence Interval|Median
2564910|NCT02604264|Primary|Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days|"This was calculated by dividing the cumulative number of PBCs by cumulative time at-risk as follows.~The National Healthcare Safety Network (NHSN) Center for Disease Control (CDC) 21-day outpatient hemodialysis patient rule is as follows: A PBC is considered a new event and counted only if it occurred 21 days or more after a previously reported PBC in the same patient; new PBC events are based on blood cultures drawn as an outpatient or within one calendar day after a hospital admission. Following a PBC additional same-type events were counted beginning 21 days following the initial event; the CVC-days were counted during this period. The CVC-days were calculated by summing the number of days each patient was at-risk of accruing a PBC. This analysis included all subjects that participated in the study that were not otherwise censored to more accurately count CVC-days."|Up to 12 months||||PBCs per 1,000 CVC-days|||Number
2564911|NCT02604212|Secondary|Pharmacokinetics of ARC-520: Terminal Elimination Half-Life (t1/2)||Through 48 hours post-dosing on Day 1 and Day 85|Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.||||||
2564912|NCT02604212|Secondary|Pharmacokinetics of ARC-520: Terminal Elimination Rate Constant (Kel)||Through 48 hours post-dosing on Day 1 and Day 85|Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.||||||
2564913|NCT02604212|Secondary|Pharmacokinetics of ARC-520: Apparent Volume of Distribution (V)||Through 48 hours post-dosing on Day 1 and Day 85|Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.||||||
2564914|NCT02604212|Secondary|Pharmacokinetics of ARC-520: Clearance (CL)||Through 48 hours post-dosing on Day 1 and Day 85|Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.||||||
2564915|NCT02604212|Secondary|Pharmacokinetics of ARC-520: Maximum Observed Plasma Concentration (Cmax)||Through 48 hours post-dosing on Day 1 and Day 85|Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.||||||
2564916|NCT02604212|Secondary|Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)||Through 48 hours post-dosing on Day 1 and Day 85|Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.||||||
2564917|NCT02604212|Secondary|Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast)||Through 48 hours post-dosing on Day 1 and Day 85|Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.||||||
2564918|NCT02604212|Secondary|Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)||Through 48 hours post-dosing on Day 1 and Day 85|Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.||||||
2564932|NCT02604199|Secondary|Pharmacokinetics of ARC-520: Apparent Volume of Distribution (V)||Through 48 hours post-dosing on Day 1 and Day 85|Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.||||||
2564933|NCT02604199|Secondary|Pharmacokinetics of ARC-520: Clearance (CL)||Through 48 hours post-dosing on Day 1 and Day 85|Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.||||||
2564919|NCT02604212|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and Discontinuations Due to AEs|An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment. A treatment emergent AE (TEAE) was defined as an AE that was not present prior to the first study drug administration and started at/after the time of initiation of administration of study drug, or an AE which was present prior to initiation of study drug administration, which increased in severity after study drug administration. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction.|Through Day 169 (± 3 days)|Safety Population: all participants who received at least one dose of study drug or placebo, and had at least one post-dose safety assessment.|||participants|||Number
2564920|NCT02604212|Secondary|Change From Baseline at Day 113 in Log qHBsAg, by Category|Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit.|Baseline, Day 113|Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.|||log IU/mL||Standard Deviation|Mean
2564921|NCT02604212|Secondary|Change From Baseline at Day 99 in Log qHBsAg, by Category|Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit.|Baseline, Day 99|Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.|||log IU/mL||Standard Deviation|Mean
2564922|NCT02604212|Secondary|Change From Baseline at Day 85 in Log qHBsAg, by Category|Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit.|Baseline, Day 85|Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.|||log IU/mL||Standard Deviation|Mean
2564923|NCT02604212|Secondary|Change From Baseline at Day 71 in Log qHBsAg, by Category|Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit.|Baseline, Day 71|Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.|||log IU/mL||Standard Deviation|Mean
2564924|NCT02604212|Secondary|Change From Baseline at Day 57 in Log qHBsAg, by Category|Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit.|Baseline, Day 57|Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.|||log IU/mL||Standard Deviation|Mean
2564925|NCT02604212|Secondary|Change From Baseline at Day 43 in Log qHBsAg, by Category|Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit.|Baseline, Day 43|Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.|||log IU/mL||Standard Deviation|Mean
2564926|NCT02604212|Secondary|Change From Baseline at Day 29 in Log qHBsAg, by Category|Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit.|Baseline, Day 29|Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.|||log IU/mL||Standard Deviation|Mean
2564927|NCT02604212|Secondary|Change From Baseline at Day 15 in Log qHBsAg, by Category|Change in log qHBsAg from baseline, categorized into the following groups: no decrease, decrease > 0 to < 0.5 log IU/mL; decrease 0.5 to 1.0 log IU/mL; decrease > 1.0 log IU/mL, tabulated by dose and treatment for each visit.|Baseline, Day 15|Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.|||log IU/mL||Standard Deviation|Mean
2564928|NCT02604212|Secondary|Change From Baseline in Log qHBsAg Over Time|Change From Baseline in log qHBsAg up to Day 99 in response to multiple doses of ARC-520 versus placebo, using a a mixed effect model for repeated measures (MMRM). Includes parameter baseline as a continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit.|Baseline, Days 15, 29, 43, 57, 71, 85, 99|Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.|||log IU/mL||Standard Deviation|Mean
2564929|NCT02604212|Primary|Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113|Change From Baseline in log qHBsAg at Day 113 in response to multiple doses of ARC-520 versus placebo, using a a mixed effect model for repeated measures (MMRM). Includes parameter baseline as a continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit.|Baseline, Day 113|Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.|||log IU/mL||Standard Error|Least Squares Mean
2564930|NCT02604199|Secondary|Pharmacokinetics of ARC-520: Terminal Elimination Half-Life (t1/2)||Through 48 hours post-dosing on Day 1 and Day 85|Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.||||||
2565244|NCT02600715|Secondary|Number of Participants Declining to Complete Procedure Due to Pain Intolerance|Number of patients that decline to proceed with entire procedure (20 injections) due to pain or discomfort.|Intraoperative||||Participants|||Count of Participants
2564935|NCT02604199|Secondary|Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)||Through 48 hours post-dosing on Day 1 and Day 85|Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.||||||
2564936|NCT02604199|Secondary|Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast)||Through 48 hours post-dosing on Day 1 and Day 85|Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.||||||
2564937|NCT02604199|Secondary|Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)||Through 48 hours post-dosing on Day 1 and Day 85|Due to the early suspension and termination of the study, all pharmacokinetic analyses were removed from the initial statistical analysis plan for this study. No collected samples were analyzed and all were destroyed.||||||
2564938|NCT02604199|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs|An AE is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. An SAE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction. A treatment emergent AE (TEAE) was defined as an AE that was not present prior to the first study medication administration and started at/after the time of initiation of administration of study medication, or an AE which was present prior to initiation of study medication administration, which increased in severity after study medication administration.|Through Day 169|Safety Population: all participants who received at least 1 dose of study treatment or placebo, and had at least 1 post-dose safety assessment.|||Participants|||Count of Participants
2564939|NCT02604199|Secondary|Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) Over Time|Change From Baseline in log qHBsAg at Day 113 in response to multiple doses of ARC-520 versus placebo, using a a mixed effect model for repeated measures (MMRM). Includes parameter baseline as a continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit.|Baseline, Day 15, 29, 43, 57, 71, 85, 99|Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.|||log IU/mL||Standard Error|Least Squares Mean
2564940|NCT02604199|Primary|Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 113|Change From Baseline in log qHBsAg at Day 113 in response to multiple doses of ARC-520 versus placebo, using a a mixed effect model for repeated measures (MMRM). Includes parameter baseline as a continuous covariate, and treatment and visit as fixed factors, interaction of treatment and visit, and interaction of parameter baseline and visit.|Baseline, Day 113|Intent to treat population: all participants who received at least 1 dose of study drug and had valid qHBsAg values at baseline and at least one time point on or after the Day 15 visit.|||log IU/mL||Standard Error|Least Squares Mean
2564941|NCT02604173|Secondary|Oxygen Saturation|measurement of oxygen saturation (%) by finger tip pulse oximeter.|24 hours||||percent saturation||Standard Deviation|Mean
2564942|NCT02604173|Secondary|Number of Participants With Severe Acute Mountain Sickness|Number of participants with severe acute mountain sickness (AMS) by Lake Lousie Questionnaire (LLQ) (score > 5).|24 hours||||Participants|||Count of Participants
2564943|NCT02604173|Primary|Number of Participants With Acute Mountain Sickness|Number of participants with acute mountain sickness (AMS) by Lake Lousie Questionnaire (LLQ)|24 hours||||Count of participants|||Number
2564944|NCT02604160|Secondary|Number of Participants With Anti-LY3113593 Antibodies Detection|Participants with a detection of anti-LY3113593 antibodies at baseline and post-baseline time point at the following levels of 1:20, 1:40 or 1:80 titer.|Day 1: Predose; Day 15, 29, 57, 85 and 113|All participants who received at least one dose of study drug, and have at least one post dose safety assessment.|||Participants|||Count of Participants
2564945|NCT02604160|Secondary|Pharmacodynamics (PD): Change From Baseline to Week 8 in Hemoglobin (Hb)||Predose; 0.5, 4 hours post-dose|Zero participants were analyzed; data not collected. Change from baseline to week 8 in Hemoglobin (Hb) was not assessed since study was concluded early at part A.||||||
2564946|NCT02604160|Secondary|PK: Area Under the Concentration Versus Time (AUCτ)|Area under the concentration versus time (AUCτ) is the AUC over the dosing interval (Q4W)|Predose; 0.5, 4 hours post-dose|All participants who received at least one dose of study drug and had evaluable PK data. PK was not assessed in placebo.|||microgram.hour/milliliter (ug*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2564947|NCT02604160|Secondary|Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3113593||Predose; 0.5, 4 hours post-dose|All participants who received at least one dose of study drug and have evaluable PK data. PK was not assessed in placebo.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2564948|NCT02604160|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|A summary of other non-serious adverse events (AEs) and all serious adverse events, regardless of causality, is located in the reported adverse events section.|Baseline through Day 29|All participants who received at least one dose of study drug or placebo, and have at least one post dose safety assessment.|||Participants|||Count of Participants
2564949|NCT02604017|Secondary|Percentage of Participants With Post-treatment Relapse in Mono-infected HCV GT1, DAA-Naïve Participants|Post-treatment relapse was defined as confirmed HCV RNA ≥LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels <LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve, received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
2565245|NCT02600715|Secondary|Post-operative Pain Score|Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).|Postoperative (within 10 minutes of the end of the BoNT procedure)||||units on a scale||Inter-Quartile Range|Median
2564950|NCT02604017|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels <LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
2564951|NCT02604017|Secondary|Percentage of Participants With On-treatment Virologic Failure in Mono-infected HCV GT1, DAA-Naïve Participants|On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA <LLOQ during treatment, or HCV RNA ≥LLOQ at end of treatment with at least 6 weeks of treatment.|Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment|All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve.|||percentage of participants||95% Confidence Interval|Number
2564952|NCT02604017|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of >1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥100 IU/mL after HCV RNA <LLOQ during treatment, or HCV RNA ≥LLOQ at end of treatment with at least 6 weeks of treatment.|Treatment Weeks 1, 2, 4, 8 (end of treatment for 8-week treatment arm), and 12 (end of treatment for 12-week treatment arm) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population).|||percentage of particpants||95% Confidence Interval|Number
2564953|NCT02604017|Secondary|Percentage of Participants With SVR12 in HCV GT1-infected, Prior Sofosbuvir (SOF) Treatment-Experienced Participants|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.|12 weeks after last actual dose of study drug|All participants in the ITT population who were HCV GT1-infected, prior SOF-treatment experienced; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2564954|NCT02604017|Secondary|Percentage of Participants With SVR12 in Co-infected HCV GT1/Human Immunodeficiency Virus Type 1 (HIV-1) Participants|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.|12 weeks after last actual dose of study drug|All participants in the ITT population who were co-infected HCV GT1/HIV-1; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2564955|NCT02604017|Secondary|Percentage of Participants With SVR12|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.|12 weeks after last actual dose of study drug|All participants in the ITT population; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2564956|NCT02604017|Secondary|Percentage of Participants With SVR12 in Mono-infected HCV GT1 Participants|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug.|12 weeks after last actual dose of study drug|All participants in the ITT population who were mono-infected HCV GT1; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2564957|NCT02604017|Primary|Percentage of Participants With SVR12: Noninferiority of 8-Week Treatment Arm to 12-Week Treatment Arm in Mono-infected HCV GT1, DAA-Naïve Participants|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.|12 weeks after the last actual dose of study drug|All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2564958|NCT02604017|Primary|Percentage of Participants With SVR12: Noninferiority of 8-Week Arm to 12-Week Arm in Mono-infected HCV GT1, DAA-Naïve Participants, Excluding Those Who Discontinued/Experienced Virologic Failure by Week 8 or Had No HCV RNA Value at Week 12 or Later|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of mono-infected HCV GT1, DAA-naïve participants (excluding those who discontinued/experienced virologic failure by Week 8 or had no HCV RNA value at Week 12 or later) who achieved SVR12 in the 8-week treatment arm compared with the 12-week treatment arm.|12 weeks after last actual dose of study drug|All participants in the ITT population who were mono-infected HCV GT1 DAA-naïve (excluding those who discontinued/experienced virologic failure by Week 8 or had no HCV RNA value at Week 12 or later); participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2564959|NCT02604017|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Mono-infected Hepatitis C Virus Genotype 1 (HCV GT1), Direct-acting Antiviral Agent (DAA) Naïve Participants in the 12-Week Treatment Arm|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. The primary efficacy endpoint was noninferiority of the percentage of participants who achieved SVR12 in the 12-week treatment group compared with the historical control rate for HCV GT1 subjects who are treatment-naïve or treated with pegylated-interferon alfa-2a or alfa-2b and ribavirin (pegIFN/RBV).|12 weeks after the last actual dose of study drug|All participants in the ITT population who were mono-infected HCV GT1, DAA-naïve; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants|||Number
2564970|NCT02603952|Primary|Number of Participants With Any Solicited Influenza Symptoms From Day 1 Through Day 10|Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).|Day 1 (post-dose) through Day 10|As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.|||Participants|||Count of Participants
2565246|NCT02600715|Secondary|Pre-analgesia Pain Score|Measured using NRS. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain).|Baseline||||units on a scale||Inter-Quartile Range|Median
2564960|NCT02603952|Secondary|Percentage of Participants With Virus Containing Known Oseltamivir Resistance-Associated Mutations|Genotypic analysis was performed to identify all amino acid changes in neuraminidase (NA) gene between each baseline (Day1) sample and the participant's corresponding last sample sequenced. Percentage of participants with virus containing known oseltamivir resistance-associated mutations (change in the NA genes) is reported. Due to the fact that the percentage of participants with virus containing known oseltamivir resistance-associated mutation was zero across all participant samples analyzed, no additional per arm analyses were performed.|From Baseline (Day 1) to Day 13|PP population. Participants without confirmed influenza A at baseline were excluded from the PP population. Participants with confirmed Influenza A positive and Influenza A concentrations greater than the LLOQ were analyzed.|||Percentage of Participants|||Number
2564961|NCT02603952|Secondary|Number of Participants With Viral Susceptibility to MEDI8852 as Determined by a Cell Based Microneutralization Assay|Viral susceptibility to MEDI8852 was measured by a Madin-Darby canine kidney (MDCK) cell-based microneutralization assay (Virospot) for viruses recovered from baseline samples and viruses recovered from samples following treatment that contain amino acid changes within the MEDI8852 binding site. Participants with detectable levels (50% tissue culture infectious dose [TCID50]) of virus were considered susceptible and were reported. Due to the fact that the number of participants with viral susceptibility to MEDI8852 binding site was zero across all participant samples analyzed, no additional per arm analyses were performed.|From Baseline (Day 1) to Day 13|PP population. Participants without confirmed influenza A at baseline were excluded from the PP population. Participants with quantifiable Influenza A (greater than LLOQ) and a unique hemagglutinin gene sequence were analyzed.|||Participants|||Count of Participants
2564962|NCT02603952|Secondary|Percentage of Participants With Amino Acid Changes in MEDI8852 Binding Site|Genotypic analysis was performed to identify all amino acid changes in MEDI8852 binding site between each baseline (Day1) sample and the participant's corresponding last sample sequenced. Percentage of participants with changes in the amino acid corresponding to MEDI8852 binding site is reported. Due to the fact that the percentage of participants with amino acid changes in MEDI8852 binding site was zero across all participant samples analyzed, no additional per arm analyses were performed.|From Baseline (Day 1) to Day 13|PP population. Participants without confirmed influenza A at baseline were excluded from the PP population. Participants with confirmed Influenza A positive and Influenza A concentrations greater than the lower limit of quantification (LLOQ) were analyzed.|||Percentage of Participants|||Number
2564963|NCT02603952|Secondary|Number of Days of Influenza Viral Shedding as Measured by qRT-PCR|Number of days of viral shedding for participants who shed influenza virus is reported. qRT-PCR was used to measure influenza viral shedding from the nasopharyngeal swabs.|From Baseline (Day 1) to Day 7; and Day 9 to Day 13|PP population. Participants without confirmed influenza A at baseline were excluded from the PP population. Participants with shedding data available for Day 1 to Day 7 and Day 9 to Day 13 were analyzed for this outcome measure.|||Days||Standard Deviation|Mean
2564964|NCT02603952|Secondary|Quantitation of Influenza Viral Shedding as Measured by qRT-PCR|qRT-PCR was used to measure influenza viral shedding from the nasopharyngeal swabs.|Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13|PP population included all randomized participants who received any portion of their protocol-specified treatment regimen with valid assay results from nasopharyngeal specimens obtained at any post-dosing time point. Participants without confirmed influenza A at baseline were excluded from the PP population.|||Log10 (viral copies/mL)||Standard Deviation|Mean
2564965|NCT02603952|Secondary|Percentage of Participants With Influenza Viral Shedding as Measured by Quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR)|Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure influenza viral shedding from the nasopharyngeal swabs. Percentage of participants who shed influenza virus are reported.|Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13|Per-protocol (PP) population included all randomized participants who received any portion of their protocol-specified treatment regimen with valid assay results from nasopharyngeal specimens obtained at any post-dosing time point. Participants without confirmed influenza A at baseline were excluded from the PP population.|||Percentage of Participants||95% Confidence Interval|Number
2564966|NCT02603952|Primary|Number of Participants With Treatment Emergent Adverse Events of Special Interest (TEAESIs)|An AE is any untoward medical occurrence attributed to study drug in a participant who received study drug. An AESI was one of scientific and medical interest specific to understanding of the study drug and may have required close monitoring and rapid communication by the investigator to the sponsor. Treatment-emergent events were between administration of study drug and Day 101 that were absent before treatment or that worsened relative to pre treatment state.|Day 1 (post-dose) through Day 101|As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.|||Participants|||Count of Participants
2564967|NCT02603952|Primary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)|A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between administration of study drug and Day 101 that were absent before treatment or that worsened relative to pre-treatment state.|Day 1 (post-dose) through Day 101|As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.|||Participants|||Count of Participants
2564968|NCT02603952|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent events were between administration of study drug and Day 28 that were absent before treatment or that worsened relative to pre-treatment state.|Day 1 (post-dose) through Day 28|As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.|||Participants|||Count of Participants
2564969|NCT02603952|Primary|Number of Participants With Any Solicited Influenza Symptoms From Day 10 Through Day 13|Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).|Day 10 through Day 13|As-treated population included all participants who were randomized and received any portion of their protocol-specified treatment regimen.|||Participants|||Count of Participants
2564971|NCT02603926|Secondary|Hippocampal Volume, as Measured by Structural MRI|Patients will undergo structural Magnetic Resonance Imaging (MRI) at baseline/pre-treatment and at 14 weeks/post-treatment. The MRI is interpreted by a trained clinician and hippocampal volume in cubic centimeters is measured and recorded. Larger values reflect greater volumes of the hippocampus, and greater hippocampal volume post-treatment may be indicative of increased neurogenesis. Mean hippocampal volume and standard deviation at baseline/pre-treatment and post-treatment is reported here.|Baseline/pre-treatment and 14 weeks/post-treatment|1 subject was unable to undergo structural MRI procedure at baseline and post-treatment.|||cubic centimeters||Standard Deviation|Mean
2564972|NCT02603926|Secondary|CATSYS Dot-to-Dot Tremor Intensity (CATSYS DTD TI)|The CATSYS system is a portable device recording various measures of neuromotor control, including tremor. The CATSYS Dot-to-Dot Tremor Intensity (DTD TI) protocol quantifies tremor by having a participant hold a tremor pen as they would an ordinary pen, with the elbow joint bent at a right angle and free of body contact, and the pen positioned approximately 4 inches from the navel. Subjects are instructed to use the pen first to tap the center of two circular stickers, approximately 0.5 inch in diameter, placed on opposite ends of the bottom portion of the computer monitor; then, subjects are instructed to trace a line across the table using the tremor pen. The pen is connected to a computer with sensors that measure tremor intensity (TI) in units of meters per second (m/s). Larger values reflect greater tremor intensity. Mean right-hand and left-hand TI and standard deviation at baseline/pre-treatment and at 14 weeks/post-treatment are reported here.|Baseline/pre-treatment and 14 weeks/post-treatment|CATSYS DTD TI was completed by all subjects.|||meters per second (m/s)||Standard Deviation|Mean
2564973|NCT02603926|Secondary|Behavioral Dyscontrol Scale - 2 (BDS-2) Total Score|The BDS-2 is a validated 9-item assessment measuring the ability to regulate purposeful, goal-directed activity and to engage in activities of daily living, with focus on motor items. Each of the 9 items is scored on a scale of 0 to 3, resulting in a summed total score ranging from 0 to 27. Higher scores reflect fewer errors and stronger ability to regulate motor activities. Mean and standard deviation for total score at baseline/pre-treatment and at 14 weeks/post-treatment are presented here.|Baseline/pre-treatment and 14 weeks/post-treatment|BDS-2 was completed for all enrolled subjects.|||score on a scale||Standard Deviation|Mean
2564974|NCT02603926|Primary|California Verbal Learning Test II (CVLT2) Trial 1-5 Free Recall Total Raw Score|California Verbal Learning Test II (CVLT2) is an assessment measuring working memory. Trials 1-5 measure the total number of words remembered after 5 repeated trials and are summed to generate a raw score (called Trial 1-5 Free Recall Total Raw Score) ranging from 0 to 80, with higher scores reflecting better working memory. Mean and standard deviation for raw score at baseline/pre-treatment and at 14 weeks/post-treatment are presented here.|Baseline/pre-treatment and 14 weeks/post-treatment|Primary outcome measure (CVLT2) was completed for all enrolled subjects.|||score on a scale||Standard Deviation|Mean
2564975|NCT02603887|Secondary|Overall Survival|Participants in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease|Time of start of treatment to death from any cause up to 2 years and 6 months||||Participants|||Count of Participants
2564976|NCT02603887|Secondary|Clinical Benefit Rate|Minor response or better assessed by IMWG criteria for multiple myeloma after 8 cycles of therapy with pembrolizumab|From cycle 1 to cycle 8, up to 168 days|Clinical benefit rate is described as minor response or better assessed by IMWG criteria for multiple myeloma after 8 cycles of therapy with pembrolizumab. 1 participant of 13 achieved sCR|||Participants|||Count of Participants
2564977|NCT02603887|Secondary|Number of Participants That Had Progression to Multiple Myeloma|Progressive disease assessed by IMWG criteria for multiple myeloma after 8 cycles of therapy with pembrolizumab.|At 30 months from study entry||||Participants|||Count of Participants
2564978|NCT02603887|Primary|Overall Response Rate (ORR)|Overall response rate is defined as patients who have achieved partial response or higher as described per IMWG criteria for multiple myeloma after 8 cycles of therapy with pembrolizumab. Will be measured according to International Myeloma Working Group Criteria (IMWG) criteria. Response rate will be estimated accordingly. Each cycle has a duration of 21 days.|From cycle 1 to cycle 8, up to 168 days||||Participants|||Count of Participants
2564979|NCT02603809|Other Pre-specified|Supportive Analysis of Primary Endpoint: Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough|"Participants had their blood pressure measured at the study site using the BpTRU® device. The BpTRU® is an automatic unattended office blood pressure measurement device. Six measurements, at rest, per participant per visit were performed. The mean of the last 5 measurements was used for the analysis.~The absolute change in mean trough sitting diastolic blood pressure (SiDBP) measured by from baseline (i.e., at randomization) to week 8 (Day 56). A negative change indicates a decrease in the diastolic blood pressure from the start of treatment."|Baseline (Day -1 to Day 1) and end of double-blind treatment (Day 55 and Day 56)|The Full Analysis Set (FAS) includes all participants randomized who had a baseline mean trough SiDBP. Participants were evaluated according to the study treatment they have been assigned to. Missing data was analyzed by LOCF (Last Observation Carried Forward).|||mmHg||Standard Deviation|Mean
2564980|NCT02603809|Secondary|Ratio of Group Mean at Trough to Group Mean at Peak for Diastolic Blood Pressure Based on Ambulatory Blood Pressure Monitoring (ABPM)|"Ratio of group mean at trough to group mean at peak was calculated from the diastolic ambulatory blood pressure monitoring performed over a 24-hour period with the ABPM device. The trough (the smallest blood pressure reduction) and the peak (the highest blood pressure reduction) ratio show the extent of blood pressure lowering throughout the 24-hour dosing interval in the group.~The group mean trough (at 20-24 hours) to group mean (at 2-6 hours) peak of diastolic blood pressure were examined to evaluate the extent to which once-daily dosing criteria were met (trough-to-peak values greater than 0.5).~The ratio is positive if there was a decrease in diastolic blood pressure at both the trough and peak times at the end of treatment (Day 55 to Day 56) when compared to baseline (Day -1 to Day 1).~For ambulatory blood pressure monitoring the baseline was the period from the time of last run-in placebo intake up to the time of the first double-blind treatment intake."|Baseline (Day -1 to Day 1) and end of double-blind treatment (Day 55 and Day 56)|All participants in a treatment group with a full set of ABPM (Ambulatory Blood Pressure Monitoring) values over the 24-hour period at baseline and at Week 8.|||Ratio of mean at trough to mean at peak|||Number
2564981|NCT02603809|Secondary|Change From Baseline to End of Double-blind Treatment in 24-hour Diastolic and Systolic Ambulatory Blood Pressure Monitoring (ABPM)|"Diastolic and systolic ambulatory blood pressure monitoring was performed over a 24-hour period with the ABPM device (Mobil-o-Graph) set to record diastolic and systolic blood pressure at a pre-defined time. Over a 24-hour period 3 measurements per hour during the day and 2 per hour during the night were made. The blood pressure measurements were derived from the area under the diastolic and systolic blood pressure curves and divided by the time span and averaged.~For ambulatory blood pressure monitoring the baseline was the period from the time of last run-in placebo intake up to the time of the first double-blind treatment intake."|Baseline (Day -1 to Day 1) and end of double-blind treatment (Day 55 and Day 56)|All participants in a treatment group with a full set of ABPM (Ambulatory Blood Pressure Monitoring) values over the 24-hour period at baseline and at Week 8.|||mmHg||Standard Error|Mean
2564982|NCT02603809|Secondary|Response Rates at End of Double-blind Treatment Period Based on Trough Sitting Systolic Blood Pressure|"Participants had their blood pressure measured at the study site using the BpTRU® device. The BpTRU® is an automatic unattended office blood pressure measurement device. Six measurements, at rest, per participant per visit were performed. The mean of the last 5 measurements was used for the analysis.~A participant was a responder if the reduction from baseline in mean trough sitting systolic blood pressure (SiSBP) was 20 mmHg or greater-than 20 mmHg."|Baseline (Day 1) and end of double-blind treatment (Day 56)|Modified Per Protocol Set (mPPS).|||Participants|||Count of Participants
2564983|NCT02603809|Secondary|Response Rates at End of Double-blind Treatment Period Based on Trough Sitting Diastolic Blood Pressure|"Participants had their blood pressure measured at the study site using the BpTRU® device. The BpTRU® is an automatic unattended office blood pressure measurement device. Six measurements, at rest, per participant per visit were performed. The mean of the last 5 measurements was used for the analysis.~A participant was a responder if the reduction from baseline in mean trough sitting diastolic blood pressure (SiDBP) was 10 mmHg or greater-than 10 mmHg."|Baseline (Day 1) and end of double-blind treatment (Day 56)|Modified Per Protocol Set (mPPS).|||Participants|||Count of Participants
2564984|NCT02603809|Secondary|Control Rates at the End of the Double-blind Treatment Period Based on Trough Sitting Diastolic and Systolic Blood Pressure|"Participants had their blood pressure measured at the study site using the BpTRU® device. The BpTRU® is an automatic unattended office blood pressure measurement device. Six measurements, at rest, per participant per visit were performed. The mean of the last 5 measurements was used for the analysis. The Canadian Hypertension Education Program (CHEP) issued guidelines proposing cut-offs of 85 mmHg for diastolic blood pressure and 135 mmHg for systolic blood pressure specifically focusing on measurement by automated office blood pressure measurement. The number of participants at the end of the 8-week treatment period that had values below the protocol and CHEP cut-off values are reported.~The initial protocol control rates at Week 8 (Day 56) on trough SiDBP are also reported and were defined as a SiDBP of less than 90 mmHg and a SiSBP of less than 140 mmHg."|End of double-blind treatment (Day 56)|Modified Per Protocol Set (mPPS). All participants who had diastolic and systolic blood pressure measurements at Week 8 of the double-blind treatment period and that did not have any major protocol deviation were analyzed.|||Participants|||Count of Participants
2564985|NCT02603809|Secondary|Change From Baseline to End of Double-blind Treatment in Sitting Systolic Blood Pressure at Trough|"Participants had their blood pressure measured at the study site using the BpTRU® device. The BpTRU® is an automatic unattended office blood pressure measurement device. Six measurements, at rest, per participant per visit were performed. The mean of the last 5 measurements was used for the analysis.~The absolute change in mean trough sitting systolic blood pressure (SiSBP) measured by from baseline (i.e., at randomization) to week 8 (Day 56). A negative change indicates a decrease in the systolic blood pressure from the start of treatment."|Baseline (Day 1) and end of double-blind treatment (Day 56)|Modified Per-protocol set (mPPS). All participants who had a mean trough sitting systolic blood pressure (SiSBP) at Week 8 of the double-blind treatment period and that did not have any major protocol deviation were analyzed.|||mmHg||Standard Deviation|Mean
2564986|NCT02603809|Primary|Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough|"Participants had their blood pressure measured at the study site using the BpTRU® device. The BpTRU® is an automatic unattended office blood pressure measurement device. Six measurements, at rest, per participant per visit were performed. The mean of the last 5 measurements was used for the analysis.~The absolute change in mean trough sitting diastolic blood pressure (SiDBP) measured by from baseline (i.e., at randomization) to week 8 (Day 56). A negative change indicates a decrease in the diastolic blood pressure from the start of treatment."|Baseline (Day 1) and end of double-blind treatment (Day 56)|Modified Per-protocol set (mPPS). All participants who had a mean trough sitting diastolic blood pressure (SiDBP) at Week-8 of the double-blind treatment period and that did not have any major protocol deviation were analyzed.|||mmHg||Standard Deviation|Mean
2564987|NCT02603666|Primary|Elastographic Value in kPa Measured by Fibroscan|Elastographic values given in kPa by Fibroscan. All patients undergo elastographic measurement of the liver and ultrasound of the liver. The grade of fibrosis is to be established by setting the cut-off for cystic fibrosis patients.|Within 28 days in connection with their annual evaluation at a single point of time||||kPa||95% Confidence Interval|Mean
2564988|NCT02603419|Secondary|Expansion Phase: Number of Participants With Phenotype of Tumor Infiltrating Lymphocytes (TILs) in Tumor Biopsy||Pre-treatment tumor biopsy for baseline and on-treatment biopsy at Day 7 of Cycle 3|Data for this outcome measure was not collected due to the limited number of participants were enrolled into the expansion phase prior to study termination.||||||
2564989|NCT02603419|Secondary|Expansion Phase: The Last Time Point of the Last Quantifiable Concentration (Tlast) of Avelumab After Single and Multiple Dose|The last time point of the last quantifiable concentration (tlast), after single and multiple dose.|pre-dose and 1 hour post-dose on Day 1 of Cycles 1, 2 and 3|Data for this outcome measure was not collected due to early termination of study.||||||
2564990|NCT02603419|Secondary|Expansion Phase: Pre-Dose Concentration During Multiple Dosing (Ctrough) of Avelumab After Single and Multiple Dose||pre-dose and 1 hour post-dose on Day 1 of Cycles 1, 2 and 3|Data for this outcome measure was not collected due to early termination of study.||||||
2564991|NCT02603419|Secondary|Expansion Phase: Time to Attain Maximum Observed Plasma Concentration (Tmax) of Avelumab After Single and Multiple Dose||pre-dose and 1 hour post-dose on Day 1 of Cycles 1, 2 and 3|Data for this outcome measure was not collected due to early termination of study.||||||
2564993|NCT02603419|Secondary|Expansion Phase: Area Under the Plasma Concentration-Time Profile From Time Zero (Pre-Dose) to the Next Dose (AUC0-tau) of Avelumab, After Single and Multiple Dose|AUCtau was defined as area under the plasma concentration-time profile from time zero (pre-dose) to the next dose (AUC0-tau) of avelumab, after single and multiple dose.|pre-dose and 1 hour post-dose on Day 1 of Cycles 1, 2 and 3|Data for this outcome measure was not collected due to early termination of study.||||||
2564994|NCT02603419|Secondary|Expansion Phase: Maximum Observed Plasma Concentration (Cmax) of Avelumab After Single and Multiple Dose||pre-dose and 1 hour post-dose on Day 1 of Cycles 1, 2 and 3|Data for this outcome measure was not collected due to early termination of study.||||||
2564995|NCT02603419|Secondary|Expansion Phase: Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinity (AUC0-inf), After Single and Multiple Dose|AUC(0-inf) was defined as area under the plasma concentration-time profile from time zero to infinity AUC(0-inf), after single and multiple dose.|pre-dose and 1 hour post-dose on Day 1 of Cycles 1, 2 and 3|Data for this outcome measure was not collected due to early termination of study.||||||
2564996|NCT02603419|Secondary|Expansion Phase: Number of Participants With Acute and Chronic Graft Versus Host Disease (GVHD)|Acute GvHD is a reaction of donor immune cells against host tissues. The three main tissues that acute GvHD affects are the skin, liver and gastrointestinal tract. Chronic GvHD is a syndrome of variable clinical features resembling autoimmune and other immunologic disorders. Manifestations of chronic GvHD may be restricted to a single organ or site or may be widespread, with profound impact on quality of life.|From treatment start in expansion phase up to 90 days after last administration of study drug (maximum duration of 14 months)|FAS included all randomized participants.|||Participants|||Count of Participants
2564997|NCT02603419|Secondary|Expansion Phase: Number of Participants With Laboratory Abnormalities of Grade 3 Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03|As per NCI-CTCAE v 4.03, Grade >= 3 criteria were; Alanine aminotransferase: 0 LLN, 0.58 ULN microkat/L (microkatal /L); GGT: 0 LLN, 0.63 ULN microkat/L, Glucose: 4.11 LLN, 5.88 ULN mmol/L, LOW Sodium: 136 LLN, 146 ULN mmol/L; Prothrombin intl. normalized ratio: 0.9 LLN, 1.2 ULN; LOW lymphocytes (10^9/L); 1.5 LLN, 4.0 ULN; Platelets (10^9/L): 130 LLN, 400 ULN. Only those category in which at least one participant had data were reported.|From first dose of study drug to 90 days after last administration of study drug (maximum duration of 14 months)|Safety analysis set included all participants who receive at least one dose of study drug.|||Participants|||Count of Participants
2564998|NCT02603419|Secondary|Expansion Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Related TEAEs and TEAEs Graded >=3 Based on, National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03: Grade 3: severe or medically significant but not immediately life-threatening, or prolongation of existing hospitalization indicated; Grade 4: life-threatening consequence; Grade 5: death related to AE. SAE was an AE resulting in any of following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or congenital anomaly. TEAEs: an event that emerged during treatment period (From first dose of study drug until end of expansion phase [From first dose of study drug to 90 days after last administration of study drug (maximum duration of 14 months)] that was absent before treatment, or worsened during treatment period relative to pre-treatment state. AE was considered related to study drug if event was assessed by investigator as probably or possibly related.|From first dose of study drug to 90 days after last administration of study drug (maximum duration of 14 months)|Safety analysis set included all participants who receive at least one dose of study drug.|||Participants|||Count of Participants
2564999|NCT02603419|Secondary|Expansion Phase: Overall Survival|Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.|From treatment start in expansion phase until death (maximum duration of 14 months)|Data for this outcome measure was not collected due to the limited number of participants were enrolled into the expansion phase prior to study termination.||||||
2565000|NCT02603419|Secondary|Expansion Phase: Progression-Free Survival (PFS) as Assessed by Investigator and by Blinded Independent Central Review (BICR)|PFS was defined as time (in months) from date of randomization to the first documentation of disease progression or death (due to any cause), whichever occurred first. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.|From treatment start in expansion phase to date of first documentation of objective Progressive Disease (PD) or death due to any cause, whichever occurs first (maximum duration of 14 months)|Data for this outcome measure was not collected due to the limited number of participants were enrolled into the expansion phase prior to study termination.||||||
2565001|NCT02603419|Secondary|Expansion Phase: Percentage of Participants With Disease Control (DC) as Assessed by Investigator and by Blinded Independent Central Review (BICR)|Disease Control (DC) was defined as the best overall response of CR, PR, or SD. CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if >1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75 percent in the sum of the products of the greatest diameters. PR was defined >=50% decreased in the sum of products of the greatest diameters (SPD) of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >=50% in the SPD and Stable Disease was defined as less than a PR but not progressive disease. To qualify as a best overall response of SD, at least one SD assessment must be observed >=6 weeks after start date and before disease progression.|From treatment start in expansion phase to PD, death or start of new anti-cancer therapy (maximum duration of 14 months)|Data for this outcome measure was not collected due to the limited number of participants were enrolled into the expansion phase prior to study termination.||||||
2565002|NCT02603419|Secondary|Expansion Phase: Duration of Response (DR) as Assessed by Investigator and by Blinded Independent Central Review (BICR)|Duration of Response (DR) is defined, for participants with an objective response, as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective progression of disease (PD) or to death due to any cause, whichever occurs first. CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if >1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75 percent in the sum of the products of the greatest diameters. PR was defined >=50% decreased in the sum of products of the greatest diameters (SPD) of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >=50% in the SPD.|From first documentation of objective response in expansion phase to date of first documentation of objective PD or death due to any cause (maximum duration of 14 months)|Data for this outcome measure was not collected due to the limited number of participants were enrolled into the expansion phase prior to study termination.||||||
2565003|NCT02603419|Secondary|Expansion Phase: Time to Tumor Response (TTR) as Assessed by Investigator and by Blinded Independent Central Review (BICR)|Time to Tumor Response (TTR) was defined, for participants with an objective response as the time from 'start date' to the first documentation of objective tumor response (CR or PR). CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if >1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75 percent in the sum of the products of the greatest diameters. PR was defined >=50% decreased in the sum of products of the greatest diameters (SPD) of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >=50% in the SPD.|From treatment start in expansion phase to first documentation of objective response (CR or PR) (maximum duration of 14 months)|Data for this outcome measure was not collected due to the limited number of participants were enrolled into the expansion phase prior to study termination.||||||
2565004|NCT02603419|Secondary|Expansion Phase: Percentage of Participants With Objective Response as Assessed by Investigator|Objective response was defined as CR or PR according to the Response Criteria for Malignant Lymphoma, from 'start date' until disease progression or death due to any cause. CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if >1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75 percent in the sum of the products of the greatest diameters. PR was defined >=50% decreased in the SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >=50% in the SPD. (PD: >= 20% and >= 5-mm increase in sum of target lesion diameters in reference to smallest sum on study and/or substantial worsening in non-target disease).|From treatment start in expansion phase until disease progression or death due to any cause (maximum duration of 14 months)|Data for this outcome measure was not collected due to the limited number of participants were enrolled into the expansion phase prior to study termination.||||||
2565005|NCT02603419|Secondary|Lead-in Phase: Progression-Free Survival (PFS) as Assessed by Investigator|PFS was defined as time (in months) from date of randomization to the first documentation of disease progression or death (due to any cause), whichever occurred first. Progression as per RECIST 1.1, was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered as progression of disease.|From randomization to the date of progression of disease or death due to any cause, whichever occurs first (maximum duration of 32 months)|The FAS included all randomized participants.|||months||95% Confidence Interval|Median
2565006|NCT02603419|Secondary|Lead-in Phase: Duration of Response (DR) as Assessed by Investigator|DR is defined, for participants with an objective response, as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective PD or to death due to any cause, whichever occurs first. CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if >1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75 percent in the sum of the products of the greatest diameters. PR was defined >=50% decreased in the SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >=50% in the SPD.(PD: >= 20% and >= 5-mm increase in sum of target lesion diameters in reference to smallest sum on study and/or substantial worsening in non-target disease).|From first documentation of objective response to date of first documentation of objective PD or death due to any cause (maximum duration of 32 months)|The FAS included all randomized participants. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2565007|NCT02603419|Secondary|Lead-in Phase: Time to Tumor Response (TTR) as Assessed by Investigator|TTR was defined, for participants with an objective response as the time from 'start date' to the first documentation of objective tumor response (CR or PR). CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if >1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75 percent in the sum of the products of the greatest diameters. PR was defined >=50% decreased in the SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >=50% in the SPD.|From the date of randomization to the first documentation of objective response (CR or PR) (maximum duration of 32 months)|The FAS included all randomized participants. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||months||Full Range|Median
2565277|NCT02599766|Secondary|Mood 3: Satisfaction Self-assessment|Assessed via visual analogue scale as rating by the therapist Satisfaction during the therapy sessions was assessed by the patient themselves using a VAS ranging from 0 (unsatisfied) to 160 (satisfied).|6 weeks||||units on a scale||Standard Deviation|Mean
2565008|NCT02603419|Secondary|Lead-in Phase: Percentage of Participants With Disease Control (DC) as Assessed by Investigator|DC: best overall response of CR, PR, or stable disease (SD). CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if >1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75% in sum of the products of greatest diameters. PR was defined >=50% decreased in SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >=50% in SPD and SD was defined as < PR but not progressive disease. To qualify as a best overall response of SD, at least one SD assessment must be observed >=6 weeks after start date and before disease progression. (Disease progression: >= 20% and >= 5-mm increase in sum of target lesion diameters in reference to smallest sum on study and/or substantial worsening in non-target disease).|From randomization to PD, death or start of new anti-cancer therapy (maximum duration of 32 months)|FAS included all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2565009|NCT02603419|Secondary|Lead-in Phase: Percentage of Participants With Objective Response as Assessed by Investigator|Objective response: complete response (CR) or partial response (PR) according to the Response Criteria for Malignant Lymphoma, from 'start date' until disease progression (Disease progression: >= 20% and >= 5-mm increase in sum of target lesion diameters in reference to smallest sum on study and/or substantial worsening in non-target disease) or death due to any cause. CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if >1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75 percent in sum of products of greatest diameters. PR was defined >= 50% decreased in the SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >=50% in the SPD.|From randomization until disease progression or death due to any cause (maximum duration of 32 months)|The FAS included all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2565010|NCT02603419|Secondary|Lead-in Phase: Number of Participants With T Cell Immunophenotype||Day 1 of Cycles 1, 2, 3, 4, 7, 10 and at End of Treatment (maximum duration of 29 months)|Data for this outcome measure was not collected and analyzed, as the assay (which was planned for this parameter) could not be used due to quality issues.||||||
2565011|NCT02603419|Secondary|Lead-in Phase: Number of Participants With Gene Expression of Transcripts Associated With Immune Activation and Regulation||Day 1 (pre-dose) and Day 14 of Cycle 1, Day 7 of Cycle 2, Day 1 (pre-dose) of Cycle 3, 5, 7; and at End of Treatment (maximum duration of 29 months)|Data for this outcome measure was not collected and analyzed due to lack of availability of tumor biopsy tissue for analysis.||||||
2565012|NCT02603419|Secondary|Lead-in Phase: Number of Participants With Phenotype of Tumor Infiltrating Lymphocytes (TILs) in Tumor Biopsy||Day 1 (pre-dose) and Day 14 of Cycle 1, Day 7 of Cycle 2, Day 1 (pre-dose) of Cycle 3, 5, 7; and at End of Treatment (EOT) (maximum duration of 29 months)|Data for this outcome measure was not collected and analyzed due to lack of availability of tumor biopsy tissue for analysis.||||||
2565013|NCT02603419|Secondary|Expansion Phase: Number of nAb Ever Positive Participants For Serum nAb Titer for Avelumab|Serum samples were assayed for nAb using a validated analytical method.|Day 1 up to Month 14|Analysis was performed on participants who had received at least one dose of study drug and who had nAb ever-positive results. Here “0” in overall number of participants analyzed signifies that there were no nAb ever-positive participants in the specified group.||||||
2565014|NCT02603419|Secondary|Lead-in Phase: Number of nAb Ever Positive Participants For Serum nAb Titer for Avelumab|Serum samples were assayed for nAb using a validated analytical method. Number of nAb ever positive participants for serum nAb titer (1) is reported.|Day 1 up to Month 29|Analysis was performed on participants who had received at least one dose of study drug and who had nAb ever-positive results. Here “0” in overall number of participants analyzed signifies that there were no nAb ever-positive participants in that specified group.|||Participants|||Count of Participants
2565015|NCT02603419|Secondary|Expansion Phase: Number of ADA Ever Positive Participants For Each Serum ADA Titers for Avelumab|Serum samples were assayed for ADA using a validated analytical method. Number of ADA ever positive participants for each serum ADA titer (180, 4860, 43740 and 131220) are reported.|Day 1 up to Month 14|Analysis was performed on participants who had received at least one dose of study drug and who had ADA ever-positive results.|||Participants|||Count of Participants
2565016|NCT02603419|Secondary|Lead-in Phase: Number of ADA Ever Positive Participants For Each Serum ADA Titers for Avelumab|Serum samples were assayed for ADA using a validated analytical method. Number of ADA ever positive participants for each serum ADA titer (180, 4860, 43740 and 131220) are reported.|Day 1 up to Month 29|Analysis was performed on participants who had received at least one dose of study drug and who had ADA ever-positive results. Here “0” in overall number of participants analyzed signifies that there were no ADA ever-positive participants in that specified group”.|||Participants|||Count of Participants
2565017|NCT02603419|Secondary|Expansion Phase: Number of Participants With Neutralizing Antibodies (nAb) Status|nAb against avelumab in serum samples was determined and reported separately for nAb never-positive and nAb ever-positive participants. nAb never-positive participants were those who had no positive (titer less than cutpoint [0.71]) nAb results at any time point. nAb ever-positive participants were defined as those who had at least one positive (titer greater than or equal to cutpoint [0.71]) nAb result at any time point.|Day 1 up to Month 14|The immunogenicity analysis set included all participants who received at least one dose of study drug and who had at least one nAb sample collected for avelumab.|||Participants|||Count of Participants
2565018|NCT02603419|Secondary|Lead-in Phase: Number of Participants With Neutralizing Antibodies (nAb) Status|nAb against avelumab in serum samples was determined and reported separately for nAb never-positive and nAb ever-positive participants. nAb never-positive participants were those who had no positive (titer less than cutpoint [0.71]) nAb results at any time point. nAb ever-positive participants were defined as those who had at least one positive (titer greater than or equal to cutpoint [0.71]) nAb result at any time point.|Day 1 up to Month 29|The immunogenicity analysis set included all participants who received at least one dose of study drug and who had at least one nAb sample collected for avelumab.|||Participants|||Count of Participants
2565019|NCT02603419|Secondary|Expansion Phase: Number of Participants With Anti-Drug Antibodies (ADA) Status|ADA against avelumab in serum samples was determined and reported separately for ADA never-positive and ADA ever-positive participants. ADA never-positive participants were those who had no positive (titer less than cutpoint [22.5% inhibition]) ADA results at any time point. ADA ever-positive participants were defined as those who had at least one positive (titer greater than or equal to cutpoint [22.5% inhibition]) ADA result at any time point.|Day 1 up to Month 14|The immunogenicity analysis set included all participants who received at least one dose of study drug and who had at least one ADA sample collected for avelumab.|||Participants|||Count of Participants
2565020|NCT02603419|Secondary|Lead-in Phase: Number of Participants With Anti-Drug Antibodies (ADA) Status|ADA against avelumab in serum samples was determined and reported separately for ADA never-positive and ADA ever-positive participants. ADA never-positive participants were those who had no positive (titer less than cutpoint [22.5 percentage (%) inhibition]) ADA results at any time point. ADA ever-positive participants were defined as those who had at least one positive (titer greater than or equal to cutpoint [22.5% inhibition]) ADA result at any time point.|Day 1 up to Month 29|The immunogenicity analysis set included all participants who received at least one dose of study drug and who had at least one ADA sample collected for avelumab.|||Participants|||Count of Participants
2565021|NCT02603419|Secondary|Lead-in Phase: Number of Participants With Laboratory Abnormalities Graded Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03|Hematology: Anemia (Grade)G3: Hg <8.0 grams/deciliter (g/dL); lymphocyte count decreased G3: <0.5-0.2*10^9/L, G4: <0.2*10^9/L; neutrophil count decreased: G3: <1.0-0.5*10^9/L, G4: <0.5*10^9/L; platelet count decreased: G3:<50.0-25.0*10^9/L, G4: <25.0*10^9/L; white blood cell (WBC) decreased: G3: <0.2*10^9/L, G4: <1.0*10^9/L. Chemistry: [ALT, ALP increased and AST G3: >5.0-20.0*ULN, G4: >20.0*ULN]. blood bilirubin increased: G3: >3.0-10.0*ULN, G4: >10.0 *ULN. [cholesterol high: G3: >10.34 - 12.92, G4: >12.92; hypokalemia G3: <3.0-2.5, G4: <2.5]mmol/L, creatine phosphokinase (Cpk) increased: G3: >5*ULN-10*ULN, G4: >10*ULN; gamma-glutamyl transferase (Ggt) increased: G3: >5.0-20.0*ULN, G4: >20.0*ULN; [hypertriglyceridemia G3: >500-1000, G4: >1000; hypermagnesemia, G3: >3.0-8.0, G 4: >8.0]mg/dL, Lipase increased: G3: >2.0 - 5.0*ULN, G4: >5.0*ULN, Serum amylase increased: G3: >2.0 - 5.0*ULN, G4: >5.0*ULN. Only those category in which at least one participant had data were reported.|From first dose of study drug up to 90 days after the last administration of the study drug (maximum duration of 32 months)|Safety analysis set included all participants who receive at least one dose of study drug. Here, ‘Number analyzed’ (‘n’) = Participants evaluable for this outcome measure for each specified category.|||Participants|||Count of Participants
2565022|NCT02603419|Secondary|Lead-in Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Related TEAEs and TEAEs Graded >=3 as Per National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03: Grade 3: severe or medically significant but not immediately life-threatening, or prolongation of existing hospitalization indicated; Grade 4: life-threatening consequence; Grade 5: death related to AE. SAE was an AE resulting in any of following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or congenital anomaly. A TEAEs: an event that emerged during treatment period (From first dose of study drug until end of open label phase [From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months)] that was absent before treatment,or worsened during treatment period relative to pre-treatment state. AE was considered related to study drug if event was assessed by investigator as probably or possibly related.|From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months)|Safety analysis set included all participants who receive at least one dose of study drug.|||Participants|||Count of Participants
2565023|NCT02603419|Primary|Lead-in Phase: The Last Time Point of the Last Quantifiable Concentration (Tlast) of Avelumab After Multiple Dose|The last time point of the last quantifiable concentration (tlast) of avelumab, after multiple dose.|pre-dose, 1, 6, 24, 144, 312, 336 and 504 hours post-dose on Day 1 of Cycle 2|Data for this outcome measure was not collected due to early termination of study.||||||
2565024|NCT02603419|Primary|Lead-in Phase: The Last Time Point of the Last Quantifiable Concentration (Tlast) of Avelumab After Single Dose|The last time point of the last quantifiable concentration (Tlast) of avelumab, after single dose.|pre-dose, 1, 6, 24, 144, 312 and 527 hours post-dose on Day 1 of Cycle 1|The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab.|||hours||Full Range|Median
2565025|NCT02603419|Primary|Lead-in Phase: Pre-Dose Concentration During Multiple Dosing (Ctrough) of Avelumab After Multiple Dose||pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 2|The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2565026|NCT02603419|Primary|Lead-in Phase: Time to Attain Maximum Observed Plasma Concentration (Tmax) of Avelumab After Multiple Dose|Time to reach maximum observed plasma concentration of avelumab, after multiple dose.|pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 2|The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||hours||Full Range|Median
2565027|NCT02603419|Primary|Lead-in Phase: Time to Attain Maximum Observed Plasma Concentration (Tmax) of Avelumab After Single Dose|Time to reach maximum observed plasma concentration of avelumab, after single dose.|pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 1|The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||hours||Full Range|Median
2565278|NCT02599766|Secondary|Mood 2: Bipolar Mood Dimension (Good-bad)|Assessed via the Mehrdimensionaler Befindlichkeitsfragebogen (MDBF) We analysed the bipolar mood dimension (good-bad) ranging from 4 (not at all good mood) to 20 (very good mood).|6 weeks||||units on a scale||Standard Deviation|Mean
2565028|NCT02603419|Primary|Lead-in Phase: Terminal Elimination Half-Life (t1/2) of Avelumab After Multiple Dose|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half of avelumab, after multiple dose.|pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 2|The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||days||Geometric Coefficient of Variation|Geometric Mean
2565029|NCT02603419|Primary|Lead-in Phase: Terminal Elimination Half-Life (t1/2) of Avelumab After Single Dose|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half of avelumab, after single dose.|pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 1|The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||days||Geometric Coefficient of Variation|Geometric Mean
2565030|NCT02603419|Primary|Lead-in Phase: Area Under the Plasma Concentration-Time Profile From Time Zero (Pre-Dose) to the Next Dose (AUC0-tau) of Avelumab After Multiple Dose|AUCtau was defined as area under the plasma concentration-time profile from time zero (pre-dose) to the next dose (AUC0-tau) of avelumab, after multiple dose.|pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 2|The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||hr*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2565031|NCT02603419|Primary|Lead-in Phase: Area Under the Plasma Concentration-Time Profile From Time Zero (Pre-Dose) to the Next Dose (AUC0-tau) of Avelumab After Single Dose|AUCtau was defined as area under the plasma concentration-time profile from time zero (pre-dose) to the next dose (AUC0-tau) of avelumab, after single dose.|pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 1|The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||hr*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2565032|NCT02603419|Primary|Lead-in Phase: Maximum Observed Plasma Concentration (Cmax) of Avelumab After Multiple Dose||pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 2|The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2565033|NCT02603419|Primary|Lead-in Phase: Maximum Observed Plasma Concentration (Cmax) of Avelumab After Single Dose||pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 1|The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2565034|NCT02603419|Primary|Lead-in Phase: Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinity (AUC0-inf) of Avelumab After Multiple Dose|AUC(0-inf) was defined as area under the plasma concentration-time profile from time zero to extrapolated infinity AUC(0-inf), after multiple dose.|pre-dose, 1, 6, 24, 144, 312, 336 and 504 hours post-dose on Day 1 of Cycle 2|Data for this outcome measure was not collected due to early termination of study.||||||
2565035|NCT02603419|Primary|Lead-in Phase: Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinity (AUC0-inf) of Avelumab After Single Dose|AUC(0-inf) was defined as area under the plasma concentration-time profile from time zero to extrapolated infinity AUC(0-inf), after single dose.|pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 1|The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||hour*microgram/mL (hr*mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2565036|NCT02603419|Primary|Expansion Phase: Percentage of Participants With Objective Response as Assessed by Blinded Independent Central Review (BICR)|Objective response: complete response (CR) or partial response (PR) according to the Response Criteria for Malignant Lymphoma, from 'start date' until disease progression (Disease progression: >= 20% and >= 5-mm increase in sum of target lesion diameters in reference to smallest sum on study and/or substantial worsening in non-target disease) or death due to any cause. CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if >1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75 percent in sum of products of greatest diameters. PR was defined >= 50% decreased in the sum of products of the greatest diameters (SPD) of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >=50% in the SPD.|From treatment start in expansion phase until progressive disease or death due to any cause (maximum duration of 14 months)|Data for this outcome measure (OM) was not collected due to the limited number of participants were enrolled into the expansion phase prior to study termination.||||||
2565037|NCT02603419|Primary|Lead-in Phase: Percent Target Occupancy (CD3+ T-Cells) at Day 1 of Cycle 2|Target occupancy on peripheral blood CD3+ T-cells by avelumab was investigated in human blood in vitro by flow cytometry.|Day 1 of Cycle 2|The TO analysis set included all participants who received at least one dose of study drug and who had at least one receptor occupancy blood sample collected both pre and post Cycle 1 Day 1 dose. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percentage of occupancy||Standard Deviation|Mean
2565279|NCT02599766|Secondary|Mood 1: Motivation|Assessed via visual analogue scale as self-rating Scale ranging from 0 (not motivated) to 160 (highly motivated)|6 weeks||||units on a scale||Standard Deviation|Mean
2565038|NCT02603419|Primary|Lead-in Phase: Percent Target Occupancy (CD3+ T-Cells) at Day 2 of Cycle 1|Target occupancy on peripheral blood CD3+ T-cells by avelumab was investigated in human blood in vitro by flow cytometry.|Day 2 of Cycle 1|The TO analysis set included all participants who received at least one dose of study drug and who had at least one receptor occupancy blood sample collected both pre and post Cycle 1 Day 1 dose.|||percentage of occupancy||Geometric Coefficient of Variation|Geometric Mean
2565039|NCT02603419|Primary|Lead-in Phase: Percent Target Occupancy (CD14+ Monocytes) at Day 1 of Cycle 2|Target occupancy on peripheral blood CD14+ T-cells by avelumab was investigated in human blood in vitro by flow cytometry.|Day 1 of Cycle 2|The TO analysis set included all participants who received at least one dose of study drug and who had at least one receptor occupancy blood sample collected both pre and post Cycle 1 Day 1 dose. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percentage of occupancy||Geometric Coefficient of Variation|Geometric Mean
2565040|NCT02603419|Primary|Lead-in Phase: Percent Target Occupancy (CD14+ Monocytes) at Day 2 of Cycle 1|Target occupancy on peripheral blood CD14+ T-cells by avelumab was investigated in human blood in vitro by flow cytometry.|Day 2 of Cycle 1|The Target Occupancy (TO) analysis set included all participants who received at least one dose of study drug and who had at least one receptor occupancy blood sample collected both pre and post Cycle 1 Day 1 dose.|||percentage of occupancy||Geometric Coefficient of Variation|Geometric Mean
2565041|NCT02603393|Secondary|Mean Change From Baseline in Forced Vital Capacity (FVC)|Change from baseline in forced vital capacity following 26 weeks of treatment. Trough FVC is defined as the average of the pre-dose FVC measurements at -45 min and -15 min prior to dosing at each visit except Day 182 which is the average of the post-dose FVC measurements at 23h15min and 23h45min after dosing at Day 181. Baseline is considered the Day 1 average of pre-dose measurements.|Baseline, 26 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.|||Liters||Standard Error|Least Squares Mean
2565042|NCT02603393|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication|Change from baseline in mean daily number of puffs of rescue medication (number of puffs taken in the previous 12 hours) over 26 weeks of treatment.|Baseline, 26 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.|||Number of puffs per day||Standard Error|Least Squares Mean
2565043|NCT02603393|Secondary|Transition Dyspnea Index (TDI) Score|Transitional Dyspnea Index (TDI) score presents the degree of impairment due to dyspnea. The lower the score the worse the severity of dyspnea. The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.|26 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.|||Score on a scale||Standard Error|Least Squares Mean
2565044|NCT02603393|Secondary|Transition Dyspnea Index (TDI) Score|Transitional Dyspnea Index (TDI) score presents the degree of impairment due to dyspnea. The lower the score the worse the severity of dyspnea. The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.|12 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.|||Score on a scale||Standard Error|Least Squares Mean
2565045|NCT02603393|Secondary|Mean Change From Baseline in St. George's Respiratory Questionnaire|"The St. George Respiratory Questionnaire C (SGRQ-C) is used to provide the health status measurements in this study. Baseline SGRQ-C is defined as the assessment taken right before the first dose of the double-blind drug on Day 1. Higher values correspond to greater impairment of health status. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status."|Baseline, 26 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. patients in the FAS were analyzed according to the treatment they were randomized to.|||Score on a scale||Standard Error|Least Squares Mean
2565057|NCT02603172|Secondary|Part C: t1/2 of GSK3039294 and GSK2315698|This analysis was planned but not performed for Part C as the study was terminated early during Part B.|Day 1 (pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose); Day 2 to 20 (pre-dose); Day 21 (pre-dose, and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose; Week 4 and 5|PK population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.||||||
2565058|NCT02603172|Secondary|Part C: Cmax/D of GSK3039294 and GSK2315698|This analysis was planned but not performed for Part C as the study was terminated early during Part B.|Day 1 (pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose); Day 2 to 20 (pre-dose); Day 21 (pre-dose, and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose; Week 4 and 5|PK population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.||||||
2565046|NCT02603393|Secondary|Mean Change From Baseline in St. George's Respiratory Questionnaire|"The St. George Respiratory Questionnaire C (SGRQ-C) is used to provide the health status measurements in this study. Baseline SGRQ-C is defined as the assessment taken right before the first dose of the double-blind drug on Day 1. Higher values correspond to greater impairment of health status. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status."|Baseline, 12 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.|||Score on a scale||Standard Error|Least Squares Mean
2565047|NCT02603393|Secondary|Mean Change From Baseline in Pre-dose Trough FEV1|Trough FEV1 is defined as the average of the pre-dose FEV1 measurements at -45 min and -15 min prior to dosing at each visit except Day 182 which is the average of the post-dose FEV1 measurements at 23h15min and 23h45min after dosing at Day 181. Baseline FEV1 is considered the Day 1 average of pre-dose measurements.|26 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.|||Liters||Standard Error|Least Squares Mean
2565048|NCT02603393|Secondary|Annualized Rate of COPD Exacerbations Requiring Hospitalisation|COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event.|26 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.|||COPD Exacerbations/year||95% Confidence Interval|Number
2565049|NCT02603393|Secondary|Annualized Rate of COPD Exacerbations Requiring Treatment With Systemic Glucocorticosteroids and/or Antibiotics, Moderate Exacerbations Only|COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event|26 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.|||COPD Exacerbations/year||95% Confidence Interval|Number
2565050|NCT02603393|Secondary|Annualized Rate of Moderate or Severe COPD Exacerbations|Moderate or severe COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event.|26 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.|||COPD exacerbations/year||95% Confidence Interval|Number
2565051|NCT02603393|Primary|Mean Change From Baseline in Post-dose Trough FEV1|Mean change from baseline in post-dose trough forced expiratory volume in 1 second (FEV1) following 26 weeks of treatment. Trough FEV1 is defined as the mean of the two FEV1 values measured at 23 hr 15 min and 23 hr 45 min after the morning dose taken at site on Day 181. Baseline FEV1 is defined as the average of the pre-dose FEV1 measured at -45 min and -15 min at Day 1.|Baseline, 26 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug. Patients in the FAS were analyzed according to the treatment they were randomized to.|||Liters||Standard Error|Least Squares Mean
2565052|NCT02603211|Secondary|Malignancy Estimation Using Risk Score|"The tumor risk score is calculated from the tumor size and deformation index. The scale will be from 0 to 5. With 0 being likely to be benign and 5 being likely to be malignant.~We weigh the size 30% and deformation index 70% to come with the risk score. The tumor size is given in millimeters and deformation index is unitless.~Deformation Index represents the hardness of the tumor. The amount at which the probe tip gets deformed by applying a force is called deformation index.~Under the condition that the applied force, depth of the tumor and size of the tumor phantom are kept constant, the softer tumor makes the probe tip deform less than the stiffer tumor. Hence the deformation index for stiffer inclusion will be higher than the softer tumors."|1 year||||participants|||Number
2565053|NCT02603211|Primary|Size Error in Millimeters|We obtain the image of the tumor and estimate its size. We compare this with the mammogram size data to compute the size error.|1 year||||milimeters||Standard Error|Mean
2565054|NCT02603172|Secondary|Part C: Time to Repletion of SAP|This analysis was planned but not performed for Part C as the study was terminated early during Part B.|Day 1 (pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose); Day 2 to 20 (pre-dose); Day 21 (pre-dose, and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose; Week 4 and 5|PK population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.||||||
2565055|NCT02603172|Secondary|Part C: Plasma SAP Levels of GSK3039294|This analysis was planned but not performed for Part C as the study was terminated early during Part B.|Day 1 (pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose); Day 2 to 20 (pre-dose); Day 21 (pre-dose, and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose; Week 4 and 5|PK population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.||||||
2565056|NCT02603172|Secondary|Part C: Tmax of GSK3039294 and GSK2315698|This analysis was planned but not performed for Part C as the study was terminated early during Part B.|Day 1 (pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose); Day 2 to 20 (pre-dose); Day 21 (pre-dose, and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose; Week 4 and 5|PK population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.||||||
2565280|NCT02599766|Secondary|Neutral Emotional Display|Emotional display is assessed via video coding in Noldus Observer. Percentage of the defined behavior during the therapy sessions is collected and aggregated to one measure of neutral emotion.|6 weeks||||percentage of neutral emotion||Standard Deviation|Mean
2565059|NCT02603172|Secondary|Part C: Cmax of GSK3039294 and GSK2315698|This analysis was planned but not performed for Part C as the study was terminated early during Part B.|Day 1 (pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose); Day 2 to 20 (pre-dose); Day 21 (pre-dose, and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose; Week 4 and 5|PK population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.||||||
2565060|NCT02603172|Secondary|Part C: AUC(0-t)/D of GSK3039294 and GSK2315698|This analysis was planned but not performed for Part C as the study was terminated early during Part B.|Day 1 (pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose); Day 2 to 20 (pre-dose); Day 21 (pre-dose, and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose; Week 4 and 5|PK population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.||||||
2565061|NCT02603172|Secondary|Part C: AUC(0-t) of GSK3039294 and GSK2315698|This analysis was planned but not performed for Part C as the study was terminated early during Part B.|Day 1 (pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose); Day 2 to 20 (pre-dose); Day 21 (pre-dose, and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose; Week 4 and 5|PK population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.||||||
2565062|NCT02603172|Secondary|Part C: AUC(0-inf)/D of GSK3039294 and GSK2315698|This analysis was planned but not performed for Part C as the study was terminated early during Part B.|Day 1 (pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose); Day 2 to 20 (pre-dose); Day 21 (pre-dose, and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose; Week 4 and 5|PK population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.||||||
2565063|NCT02603172|Secondary|Part C: AUC(0-inf) of GSK3039294 and GSK2315698|This analysis was planned but not performed for Part C as the study was terminated early during Part B.|Day 1 (pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose); Day 2 to 20 (pre-dose); Day 21 (pre-dose, and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose; Week 4 and 5|PK population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.||||||
2565064|NCT02603172|Secondary|Part B: Plasma Serum Amyloid P Component (SAP) Level of GSK3039294|Blood samples were collected at specified time points for GSK3039294. Pharmacodynamic (PD) population consist of all participants who received at least one dose of study medication and who also had a baseline measurement and at least one post-treatment PD measure.|Cohort 3:Days1(pre-dose, 2hour post-dose),2(pre-dose),4(pre-dose),5(pre-dose, 30min,1,2,3,4,6 hours post-dose),7(pre-dose)and 21post-dose;Cohort4:Days1(pre-dose, 2 hour post-dose),2(pre-dose),4(pre-dose), 5(pre-dose, and 2 hours post-dose) and 35post-dose|PD population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||ng/mL||Standard Deviation|Mean
2565065|NCT02603172|Secondary|Part B: Tmax of GSK3039294 and GSK2315698|Blood samples were collected at specified time points for GSK3039294 and GSK2315698. tmax was determined using standard non-compartmental methods.|Cohort 3- Day 4 and 5: pre-dose, and 0.5, 1, 2, 3, 4, and 6 hours post-dose; Cohort 4: Day 4 (pre-dose), Day 5 (pre-dose and 0.5, 1, 2, 3, 4, and 6 hours post-dose)|PK population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours||Full Range|Median
2565066|NCT02603172|Secondary|Part B: t1/2 of GSK3039294 and GSK2315698|Blood samples were collected at specified time points for GSK3039294 and GSK2315698. t1/2 was determined using standard non-compartmental methods.|Cohort 3- Day 4 and 5: pre-dose, and 0.5, 1, 2, 3, 4, and 6 hours post-dose; Cohort 4: Day 4 (pre-dose), Day 5 (pre-dose and 0.5, 1, 2, 3, 4, and 6 hours post-dose)|PK population. Data was not collected for Cohort 4a and 4b as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3). Data was not calculated for Cohort 3 as the concentration-time data does not provide an accurate representation of the terminal elimination phase for the drug. Hence, t1/2 was not derived.||||||
2565067|NCT02603172|Secondary|Part B: Cmax/D of GSK3039294 and GSK2315698|Blood samples were collected at specified time points for GSK3039294 and GSK2315698. Cmax/D was determined using standard non-compartmental methods. NA indicates that, data could not be calculated because only one participant was analyzed.|Cohort 3- Day 4 and 5: pre-dose, and 0.5, 1, 2, 3, 4, and 6 hours post-dose; Cohort 4: Day 4 (pre-dose), Day 5 (pre-dose and 0.5, 1, 2, 3, 4, and 6 hours post-dose)|PK population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2565068|NCT02603172|Secondary|Part B: Cmax of GSK3039294 and GSK2315698|Blood samples were collected at specified time points for GSK3039294 and GSK2315698. Cmax was determined using standard non-compartmental methods. NA indicates data could not be calculated because only one participant was analyzed.|Cohort 3- Day 4 and 5: pre-dose, and 0.5, 1, 2, 3, 4, and 6 hours post-dose; Cohort 4: Day 4 (pre-dose), Day 5 (pre-dose and 0.5, 1, 2, 3, 4, and 6 hours post-dose)|PK population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2565069|NCT02603172|Secondary|Part B: AUC(0-t)/D of GSK3039294 and GSK2315698|Blood samples were collected at specified time points for GSK3039294 and GSK2315698. AUC(0-t)/D was determined using standard non-compartmental methods.|Cohort 3- Day 4 and 5: pre-dose, and 0.5, 1, 2, 3, 4, and 6 hours post-dose; Cohort 4: Day 4 (pre-dose), Day 5 (pre-dose and 0.5, 1, 2, 3, 4, and 6 hours post-dose)|PK population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||h*ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2565070|NCT02603172|Secondary|Part B: AUC(0-t) of GSK3039294 and GSK2315698|Blood samples were collected at specified time points for GSK3039294 and GSK2315698. AUC(0-t) was determined using standard non-compartmental methods.|Cohort 3- Day 4 and 5: pre-dose, and 0.5, 1, 2, 3, 4, and 6 hours post-dose; Cohort 4: Day 4 (pre-dose), Day 5 (pre-dose and 0.5, 1, 2, 3, 4, and 6 hours post-dose)|PK population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2565071|NCT02603172|Secondary|Part B: AUC([0-inf]/D) of GSK3039294 and GSK2315698|Blood samples were collected at specified time points for GSK3039294 and GSK2315698. AUC(0-inf)/D was determined using standard non-compartmental methods.|Cohort 3- Day 4 and 5: pre-dose, and 0.5, 1, 2, 3, 4, and 6 hours post-dose; Cohort 4: Day 4 (pre-dose), Day 5 (pre-dose and 0.5, 1, 2, 3, 4, and 6 hours post-dose)|PK population. Data was not collected for Cohort 4a and 4b as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3). Data was not calculated for Cohort 3 as the concentration-time data does not provide an accurate representation of the terminal elimination phase for the drug. Hence, AUC([0-inf]/D) was not derived.||||||
2565072|NCT02603172|Secondary|Part B: AUC(0-inf) of GSK3039294 and GSK2315698|Blood samples were collected at specified time points for GSK3039294 and GSK2315698. AUC(0-inf) was determined using standard non-compartmental methods.|Cohort 3- Day 4 and 5: pre-dose, and 0.5, 1, 2, 3, 4, and 6 hours post-dose; Cohort 4: Day 4 (pre-dose), Day 5 (pre-dose and 0.5, 1, 2, 3, 4, and 6 hours post-dose)|PK population. Data was not collected for Cohort 4a and 4b as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3). Data was not calculated for Cohort 3 as the concentration-time data does not provide an accurate representation of the terminal elimination phase for the drug. Hence, AUC (0-inf) was not derived.||||||
2565073|NCT02603172|Secondary|Part B: Area Under the Concentration-time Curve From Time Zero to 6 Hours Post Dose (AUC[0-6]) of GSK3039294 and GSK2315698|Blood samples were collected at specified time points for GSK3039294 and GSK2315698. AUC(0-6) was determined using standard non-compartmental methods.|Cohort 3- Day 4 and 5: pre-dose, and 0.5, 1, 2, 3, 4, and 6 hours post-dose; Cohort 4: Day 4 (pre-dose), Day 5 (pre-dose and 0.5, 1, 2, 3, 4, and 6 hours post-dose)|PK population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2565074|NCT02603172|Secondary|Part A: Time to Reach Cmax (Tmax) of GSK3039294 and GSK2315698|Blood samples were collected at specified time points for GSK3039294 and GSK2315698. tmax was determined using standard non-compartmental methods.|Pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 and 48 hours post-dose|PK population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours||Full Range|Median
2565075|NCT02603172|Secondary|Part A: Terminal Half-life (t1/2) of GSK3039294 and GSK2315698|Blood samples were collected at specified time points for GSK3039294 and GSK2315698. t1/2 was determined using standard non-compartmental methods.|Pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 and 48 hours post-dose|PK population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours||Geometric Coefficient of Variation|Geometric Mean
2565076|NCT02603172|Secondary|Part A: Cmax Corrected for Dose of Prodrug (Cmax/D) of GSK3039294 and GSK2315698|Blood samples were collected at specified time points for GSK3039294 and GSK2315698. Cmax/D was determined using standard non-compartmental methods.|Pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 and 48 hours post-dose|PK population. Data could not be calculated because only one participant was analyzed. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). NA indicates that data could not be calculated because only one participant was analyzed.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2565077|NCT02603172|Secondary|Part A: Maximum Observed Plasma Concentration (Cmax) of GSK3039294 and GSK2315698|Blood samples were collected at specified time points for GSK3039294 and GSK2315698. Cmax was determined using standard non-compartmental methods.|Pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 and 48 hours post-dose|PK population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). NA indicates that data could not be calculated because only one participant was analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2565078|NCT02603172|Secondary|Part A: AUC(0-t) Corrected for Dose of Prodrug (AUC[0-t]/D) of GSK3039294 and GSK2315698|Blood samples were collected at specified time points for GSK3039294 and GSK2315698. AUC(0-t)/D was determined using standard non-compartmental methods.|Pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 and 48 hours post-dose|PK population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||h*ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2565079|NCT02603172|Secondary|Part A: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-t]) of GSK3039294 and GSK2315698|Blood samples were collected at specified time points for GSK3039294 and GSK2315698. AUC(0-t) was determined using standard non-compartmental methods.|Pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 and 48 hours post-dose|PK population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2565080|NCT02603172|Secondary|Part A: AUC(0-inf) Corrected for Dose of Prodrug (AUC[0-inf]/D) of GSK3039294 and GSK2315698|Blood samples were collected at specified time points for GSK3039294 and GSK2315698. AUC(0-inf)/D was determined using standard non-compartmental methods.|Pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 and 48 hours post-dose|PK population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||h*ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2566438|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (µmol/L)||Baseline, Week 48|Participants with measurements at given time point.|||µmol/L||Standard Deviation|Mean
2565081|NCT02603172|Secondary|Part A: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC[0-inf]) of GSK3039294 and GSK2315698|Blood samples were collected at specified time points for GSK3039294 and GSK2315698. AUC(0-inf) was determined using standard non-compartmental methods. Pharmacokinetic (PK) population consists of all participants administered at least one dose of study medication and who had at least one PK sample taken and analyzed.|Pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24 and 48 hours post-dose|PK population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2565082|NCT02603172|Primary|Part C: Number of Participants With Abnormal Cardiac Telemetry Findings|The cardiac monitoring was planned to be measured by using an appropriate nonimplantable recording device which is acceptable to the participants. This was evaluated the arrhythmic background of eligible cardiac amyloidosis participants such that false positive attribution of arrhythmias to GSK3039294 during repeat dosing was minimized. This analysis was planned but not performed for Part C as the study was terminated early during Part B.|Up to Day 35|Safety Population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.||||||
2565083|NCT02603172|Primary|Part C: Number of Participants With Abnormal Vital Signs|Vital signs included systolic and diastolic BP, pulse rate, heart rate and temperature. This analysis was planned but not performed for Part C as the study was terminated early during Part B.|Up to Day 35|Safety Population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.||||||
2565084|NCT02603172|Primary|Part C: Number of Participants With Abnormal 12-lead ECG Findings|Triplicate ECG was planned to be measured in semi-supine position after 5 minutes rest. A single 12-lead ECG was measured by using ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part C. Change from Baseline was calculated as any visit post Baseline value minus Baseline value. This analysis was planned but not performed for Part C as the study was terminated early during Part B.|Up to Day 35|Safety Population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.||||||
2565085|NCT02603172|Primary|Part C: Number of Participants With Emergent Urinalysis Parameters by PCI Criteria|Urine samples were planned to be collected and urinalysis included analysis of specific gravity, pH, glucose, protein, blood, ketones by dipstick. This analysis was planned but not performed for Part C as the study was terminated early during Part B.|Up to Day 63|Safety Population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.||||||
2565086|NCT02603172|Primary|Part C: Number of Participants With Emergent Hematology Parameters by PCI Criteria|Hematology parameters that were planned for analysis were as follows: WBC count , neutrophil count , hemoglobin , hemocrit , platelet count , and lymphocytes. This analysis was planned but not performed for Part C as the study was terminated early during Part B.|Up to Day 63|Safety Population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.||||||
2565087|NCT02603172|Primary|Part C: Number of Participants With Emergent Clinical Chemistry by PCI Criteria|PCI parameters for the clinical chemistry that were planned for analysis are as follows: albumin, calcium, glucose, magnesium, phosphorous , potassium , sodium , and total CO2. This analysis was planned but not performed for Part C as the study was terminated early during Part B.|Up to Day 63|Safety Population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.||||||
2565088|NCT02603172|Primary|Part C: Number of Participants With AEs and SAEs|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other important medical events judged by the investigator that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention. This analysis was planned but not performed for Part C as the study was terminated early during Part B.|Up to Day 63|Safety Population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.||||||
2565089|NCT02603172|Primary|Part B: Number of Participants With Abnormal Cardiac Telemetry Findings|The cardiac monitoring was measured by using an appropriate nonimplantable recording device which is acceptable to the participants. This was evaluated the arrhythmic background of eligible cardiac amyloidosis participants such that false positive attribution of arrhythmias to GSK3039294 during repeat dosing was minimized.|Cohort 3: Up to Day 8|Safety population.|||Participants|||Count of Participants
2565090|NCT02603172|Primary|Part B: Mean Change From Baseline in Heart Rate by 12-lead ECG|Triplicate ECG was measured in semi-supine position after 5 min rest. A single 12-lead ECG was measured by using ECG machine that automatically measures heart rate. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part B. Change from Baseline was calculated as any visit post Baseline value minus Baseline value.|Cohort 3: Baseline (pre-dose), Day 1 (1 hour), Days 2, 3, 4, 5, 6, 7 (pre-dose and 1 hour), 8 and 21; Cohort 4: Up to Day 35|Safety population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B.|||Beats per minute||Standard Deviation|Mean
2565102|NCT02603172|Primary|Part A: Number of Participants With Emergent Hematology by PCI Criteria|PCI ranges for the hematology parameters were as follows: white blood cell (WBC) count (low: <0.67 10^9 cells/L and high: >1.82 10^9 cells/L), neutrophil count (low: <0.83 10^9 cells/L), hemoglobin (high: >1.03 g/L in male, >1.13 g/L in female), hemocrit (high: >1.02 proportion of red blood cell [RBC] in blood for male, >1.17 proportion of RBC in blood for female), platelet count (low: <0.67 10^9 cells/L and high: 1.57 10^9 cells/L), and lymphocytes (low: <0.81 10^9 cells/L).|Day 1|Safety population|||Participants|||Count of Participants
2565091|NCT02603172|Primary|Part B: Mean Change From Baseline in 12-lead ECG|Triplicate ECG was measured in semi-supine position after 5 minutes rest. A single 12-lead ECG was measured by using ECG machine that automatically measured PR, QRS, QT, and QTcF intervals. Baseline is defined as the latest available assessment pre the first dose of study drug in Part B. Change from Baseline was calculated as any visit post Baseline value minus Baseline value.|Cohort 3: Baseline (pre-dose), Day 1 (1 hour), Days 2, 3, 4, 5, 6, 7 (pre-dose and 1 hour), 8 and 21; Cohort 4: Up to Day 35|Safety population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B.|||Millisecond||Standard Deviation|Mean
2565092|NCT02603172|Primary|Part B: Number of Participants With Abnormal Urinalysis Data by Dipstick|Urine samples were collected and urinalysis included analysis of specific gravity, pH, glucose, protein, blood, ketones by dipstick. The dipstick test gives results in a semi-quantitative manner.|Cohort 3 and 4: Up to Day 3|Safety population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B.|||Participants|||Count of Participants
2565093|NCT02603172|Primary|Part B: Number of Participants With Emergent Hematology by PCI Criteria|PCI ranges for the hematology parameters were as follows: WBC count (low: <0.67 10^9 cells/L and high: >1.82 10^9 cells/L), neutrophil count (low: <0.83 10^9 cells/L), hemoglobin (high: >1.03 g/L in male, >1.13 g/L in female), hemocrit (high: >1.02 proportion of RBC in blood for male, >1.17 proportion of RBC in blood for female), platelet count (low: <0.67 10^9 cells/L and high: 1.57 10^9 cells/L), and lymphocytes (low: <0.81 10^9 cells/L).|Cohort 3 and 4: Up to Day 3|Safety population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B.|||Participants|||Count of Participants
2565094|NCT02603172|Primary|Part B: Number of Participants With Emergent Clinical Chemistry by PCI Criteria|PCI ranges for the clinical chemistry parameters were as follows: albumin (low: <0.86 g/L), calcium (low: <0.91 mmol/L and high: >1.06 mmol/L), glucose (low: <0.71 mmol/L and high: >1.41 mmol/L), magnesium (low: <0.63 mmol/L and high: >1.03 mmol/L), phosphorous (low: <0.80 mmol/L and high: >1.14 mmol/L), potassium (low: <0.86 mmol/L and high: >1.10 mmol/L), sodium (low: <0.96 mmol/L and high: >1.03 mmol/L), and total CO2 (low: <0.86 mmol/L and high: >1.14 mmol/L).|Cohort 3 and 4: Up to Day 3|Safety population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B.|||Participants|||Count of Participants
2565095|NCT02603172|Primary|Part B:Number of Participants With AEs and SAEs|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other important medical events judged by the investigator that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention.|Cohort 3: Up to Day 21; Cohort 4: Up to Day 35|Safety population. Data was not collected as study was terminated, due to safety reasons during conduct of Part B (end of Cohort 3) whereas Cohort 4a and 4b were not recruited in Part B.|||Participants|||Count of Participants
2565096|NCT02603172|Primary|Part A: Mean Change From Baseline in Temperature|Temperature was measured in semi-supine position after 5 min rest for the participants at indicated time points. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value.|Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Safety population.|||Celsius||Standard Deviation|Mean
2565097|NCT02603172|Primary|Part A: Mean Change From Baseline in Pulse Rate|Pulse rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value.|Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Safety population.|||Beats per minute||Standard Deviation|Mean
2565098|NCT02603172|Primary|Part A: Mean Change From Baseline in Blood Pressure (BP)|Systolic BP and diastolic BP were measured in semi-supine position after 5 min rest for the participants at indicated time points. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value.|Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Safety population.|||Millimeter of mercury||Standard Deviation|Mean
2565099|NCT02603172|Primary|Part A: Mean Change From Baseline in Heart Rate by 12-lead ECG|Triplicate ECG was measured in semi-supine position after 5 min rest. A single 12-lead ECG was measured by using ECG machine that automatically measures the heart rate. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value.|Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Safety population.|||Beats per minute||Standard Deviation|Mean
2565100|NCT02603172|Primary|Part A: Mean Change From Baseline in 12-lead Electrocardiogram (ECG)|Triplicate ECG was measured in semi-supine position after 5 minutes (min) rest. A single 12-lead ECG was measured by using ECG machine that automatically measured PR, QRS, QT, and Fridericia's formula (QTcF) intervals. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value.|Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|Safety Population|||Millisecond||Standard Deviation|Mean
2565101|NCT02603172|Primary|Part A: Number of Participants With Abnormal Urinalysis Data by Dipstick|Urine samples were collected and urinalysis included analysis of specific gravity, potential of hydrogen (pH), glucose, protein, blood, ketones by dipstick. The dipstick test gives results in a semi-quantitative manner.|Day 1|Safety population|||Participants|||Count of Participants
2565796|NCT02589171|Secondary|Pain at the 12mm Camera Port Site as Assessed by a Visual Analog Scale|Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.|day 1||||units on a scale||Standard Deviation|Mean
2565103|NCT02603172|Primary|Part A: Number of Participants With Emergent Clinical Chemistry by Potentially Clinical Importance (PCI) Criteria|PCI ranges for the clinical chemistry parameters were as follows : albumin (low: <0.86 gram [g] per liter [L]), calcium (low: <0.91 millimole [mmol]/L and high: >1.06 mmol/L), glucose (low: <0.71 mmol/L and high: >1.41 mmol/L), magnesium (low: <0.63 mmol/L and high: >1.03 mmol/L), phosphorous (low: <0.80 mmol/L and high: >1.14 mmol/L), potassium (low: <0.86 mmol/L and high: >1.10 mmol/L), sodium (low: <0.96 mmol/L and high: >1.03 mmol/L), and total carbon dioxide (CO2) (low: <0.86 mmol/L and high: >1.14 mmol/L).|Day 1|Safety population.|||Participants|||Count of Participants
2565104|NCT02603172|Primary|Part A:Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participants or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization clinical chemor prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other important medical events judged by the investigator that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention. Safety population consist of all participants who received at least one dose of the study medication.|Up to Day 14|Safety population.|||Participants|||Count of Participants
2565105|NCT02603120|Secondary|Percentage Change From Baseline in Hip BMD at Week 48||Baseline; Week 48|Participants in the Hip DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2565106|NCT02603120|Secondary|Hip Bone Mineral Density at Baseline||Baseline|Hip DXA Analysis Set: participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline hip BMD values.|||g/cm^2||Standard Deviation|Mean
2565107|NCT02603120|Secondary|Percentage Change From Baseline in Spine BMD at Week 48||Baseline; Week 48|Participants in the Spine DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2565108|NCT02603120|Secondary|Spine Bone Mineral Density (BMD) at Baseline||Baseline|Spine dual X-ray absorptiometry (DXA) Analysis Set: participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline spine BMD values.|||g/cm^2||Standard Deviation|Mean
2565109|NCT02603120|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||cells/µL||Standard Deviation|Mean
2565110|NCT02603120|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Defined by the US FDA-defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set|||percentage of participants|||Number
2565111|NCT02603120|Primary|Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.|||percentage of participants|||Number
2565112|NCT02603107|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline to Week 48|Participants in the Full Analysis Set with available data were analyzed.|||cells/μL||Standard Deviation|Mean
2565113|NCT02603107|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set|||percentage of participants|||Number
2565114|NCT02603107|Primary|Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set: all participants who were randomized into the study and received at least 1 dose of study drug.|||percentage of participants|||Number
2565115|NCT02602496|Other Pre-specified|Change in Body Mass Index (Value at Week 8 Minus Value at Week 0)|Body mass index will be measured on participants at the beginning (week 0) and end of the study (week 8). Changes in body mass index will be determined.|8 weeks|Weight and height were measured to calculate the BMI. The outcome mean is the mean difference between the beginning and end of the treatment period.|||kg/m^2||Standard Error|Mean
2565116|NCT02602496|Secondary|Change in Branched Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)|Branched chain fatty acids (BCFA) are mostly saturated fatty acids (SFA) with one or more methyl branches on the carbon chain. BCFAs were extracted from stool samples and measured using gas chromatography.|8 weeks|The outcome mean is the mean difference between the beginning and the end of the study.|||mmol/g||Standard Error|Mean
2565117|NCT02602496|Secondary|Change in Fecal Short Chain Fatty Acids (Value at Week 8 Minus Value at Week 0)|Short-chain fatty acids (SCFAs) are the end products of fermentation of dietary fibers by the anaerobic intestinal microbiota. SCFAs have been shown to exert multiple beneficial effects on mammalian energy metabolism.|8 weeks|Mean outcome is the mean difference between the beginning and end of the study. SCFAs were extracted from stool samples and measured using gas chromatography.|||mmol/g||Standard Error|Mean
2565118|NCT02602496|Secondary|Change in Gut Microbiota Shannon's Alpha Diversity (Value at Week 8 Minus Value at Week 0)|The Shannon Diversity Index is a quantitative measure that reflects how many different bacterial species there are in a sample. The greater the index, the more diverse the gut microbiota. A negative change indicates a decrease in diversity and a positive change indicates an increase in diversity.|8 weeks|Alpha diversity was analyzed through the Shannon's Index. The mean outcome is the mean difference between the end and beginning of the treatment period.|||Shannon's Index||Standard Error|Mean
2565119|NCT02602496|Primary|Change in Lipopolysaccharide Binding Protein (Value at Week 8 Minus Value at Week 0)|Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for lipopolysaccharide binding protein concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.|8 weeks|Lipopolysaccharide binding protein was analyzed using an ELISA kit. The mean outcome is the mean of difference between the end and beginning of the treatment period.|||mcg/mL||Standard Error|Mean
2565120|NCT02602496|Primary|Change in High Sensitivity C-reactive Protein (Value at Week 8 Minus Value at Week 0)|Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for high sensitivity C-reactive protein concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.|8 weeks|C-reactive protein was analyzed using an ELISA kit. The mean outcome is the mean of difference between the end and beginning of the treatment period.|||mg/mL||Standard Error|Mean
2565121|NCT02602496|Primary|Change in Tumor Necrosis Factor-α (Value at Week 8 Minus Value at Week 0)|Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for tumor necrosis factor-α concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.|8 weeks|TNF-α was analyzed using an ELISA kit. The mean outcome is the mean of difference between the end and beginning of the treatment period.|||pg/mL||Standard Error|Mean
2565122|NCT02602496|Primary|Change in Interleukin-6 (Value at Week 8 Minus Value at Week 0)|Plasma samples collected from participants at the beginning (week 0) and end of the study (week 8) will be analyzed for interleukin-6 concentrations using an enzyme linked immunosorbent assay. Changes in the concentrations of these inflammatory markers will be determined from week 0 to week 8.|8 weeks|IL-6 was analyzed using an ELISA kit. The mean outcome is the mean of difference between the end and beginning of the treatment period.|||pg/mL||Standard Error|Mean
2565123|NCT02602223|Primary|Amount of Preservation of Alveolar Ridge Dimensions Following Ridge Preservation Procedures i.e., Vertical Ridge Height Change in Millimeters as Assessed Through Analysis of CBCT Scans.|Radiographic stent with a radiopaque reference plane (RRP) will be used to obtain pre-extraction CBCT scans. Approximately 3.5(±0.5)-months post extractions, a second CBCT will be taken. Radiographic Analyses will be done using radiographic image analysis software by a calibrated examiner. Initial relative crest iRC will be determined as described above from the initial CBCT. In the second CBCT, vertical distance from the iRC from initial CBCT will be used to recreate the iRC. New relative crest will be determined for each of the three planes (nRC) as above. The difference between iRC and nRC indicates change in vertical dimension at each plane (RΔVD) i.e., iRC - nRC = (RΔVD). Positive (RΔVD) values indicate relative loss of crestal bone height and negative (RΔVD) values indicate relative gain of crestal bone height.|3-4 months|Change in vertical dimension at each plane (RΔVD) i.e., iRC - nRC = (RΔVD). Positive (RΔVD) values indicate relative loss of crestal bone height and negative (RΔVD) values indicate relative gain of crestal bone height.|||millimeters||Standard Deviation|Mean
2565124|NCT02602223|Primary|Amount of Preservation of Alveolar Ridge Dimensions Following Ridge Preservation Procedures i.e., Horizontal Ridge Width Height Change in Millimeters as Assessed Through Analysis of CBCT Scans.|Radiographic stent with radiopaque reference plane (RRP) will be used to obtain pre-extraction CBCT scans. Approximately 3-months post extractions, a second CBCT will be taken. Radiographic Analyses will be done using radiographic image analysis software by a calibrated examiner. The initial relative crest (iRC) reference point will be determined. The buccal and lingual crests at the central plane of site will be marked and distances from this crest to RRP will be measured in mm. The average distance of the buccal crest height and the lingual crest height will be calculated and that value will be used to determine the iRC for that site. Initial Bucco-lingual (iRBL) measurements will be recorded at 1 mm, 3 mm and 7 mm from iRC in all five planes. The final bucco-lingual (fRBL) measurements will be recorded on the second CBCT, using the same method as described before and using the iRC reference. Differences between iRBL and the fRBL reflect change in horizontal ridge width (RΔHD).|3-4 months|Change in horizontal ridge width (RΔHD).|||millimeters||Standard Deviation|Mean
2565125|NCT02602223|Primary|Post Operative Pain|A visual Analog score (VAS) pain scale form (scale of 1 to 10) will be provided with instructions to record pain levels on both surgical sites every day for 2-weeks post-surgery. VAS score of 10 indicates highest level of pain and 0 indicates no pain. Subjects will also asked to log any pain medications taken in that 2-week period. Subjects will be seen at 1&2 weeks for post-operative evaluation and VAS forms will be collected. Data will be reported as Average VAS score.|0-2 weeks|VAS score at 24 hours post operative|||Units on a scale of 10||Standard Deviation|Mean
2565126|NCT02602223|Primary|Evaluation of Preservation of Ridge Quality Through Histological Analysis for Microarchitectural Parameters Expressed as Percentages.|Approximately 3.5(±0.5)-months post extractions, a 2.5x10mm core of bone will be removed from the center of the residual ridge using a 2.5mm inner-diameter trephine bur. Cores will be immediately placed into 10%-formalin. Cores will be process and embedded in polymethylmethacrylate and sectioned to 5μm thickness and sections will be stained with Goldener's Trichrome. With the Goldener's trichrome, mineralized bone appears as green or blue regions, osteoid appears orange-red, nuclei appears blue-grey and graft remnants appear grey. Additional differentiation between graft and new bone will be achieved by morphologically assessing each sample individually. A slide scanner will be used to image the sample (20x magnification), and a software program will be used for the histomorphometric analysis, to quantify the amount of total mineralized bone, new bone / osteoid, soft tissue, and residual graft remnants in percentages .|3-4 months|New bone/osteoid Percentages|||Percentage of New bone||Standard Deviation|Mean
2565156|NCT02601625|Secondary|Evaluation of Immunogenicity of Anifrolumab IV Infusions and SC Injections by the Measurement of Anti-drug Antibody (ADA).|Immunogenicity was assessed in all groups by the presence or absence of ADA, which was determined in serum samples using validated bioanalytical methods. The reported results are based on the confirmatory assay (positive/negative) of the ADA. The number of participants with positive, negative and missing results are reported for each time point using the safety analysis set.|Pre-dose and at Days 5 and Day 29, up to 85 days|The safety analysis set included all subjects who received at least 1 dose of IMP (anifrolumab or placebo) and for whom any safety post-dose data were available.|||Participants|||Number
2565127|NCT02602223|Primary|Evaluation of Preservation of Ridge Quality Through Microtomographic Analysis for Microarchitectural Parameters Expressed as Percentages.|Approximately 3-months post extractions, a 2.5x10mm core of bone will be removed from the center of the residual ridge using a 2.5mm inner-diameter trephine bur. Cores will be immediately placed into 10%-formalin. A high-resolution microtomographic scanner will be used and images will be scanned at a voxel size of 8µm3. Moist bone cores will be wrapped in paraffin and scanned in air. Cores will be rotated in 0.7 degree increments with 450milli second time exposition. A 0.5m aluminum filter will be used to remove image noise. After scanning, 3D microstructural image data will be reconstructed using software. Structural indices will be calculated using a software. The micro-architectural variables; bone volume density (BV/TV), and bone surface density (BS/BV); will be quantified and reported as percentages.|3-4 month|The micro-architectural variable; bone volume density (BV/TV),was quantified and is reported as percentages.|||Percentage of BV/TV||Standard Deviation|Mean
2565128|NCT02602223|Primary|Amount of Preservation of Alveolar Ridge Dimensions i.e..,Clinical Horizontal Ridge Width Change in Millimeter as Result of Ridge Preservation Procedures|A radiographic stent will be fabricated with reproducible access holes ≈5 mm apical to the mid-facial and mid-lingual gingival margin of the teeth to be extracted. On day of surgery, a calibrated examiner masked to treatment allocation, will record initial clinical bucco-lingual (iCBL) ridge measurements in millimeters (mm), through the access holes in the stent, using calipers. Approximately 3.5(±0.5)-months post extractions, the calibrated examiner masked to treatment allocation, will record the final clinical bucco-lingual (fCBL) ridge measurements in mm using the calipers as described earlier. The difference between fCBL and iCBL will be calculated as change in clinical horizontal ridge width dimensions in mm (cΔHD).|3-4 months|change in clinical horizontal ridge width dimensions in mm - cΔHD|||millimeters|Participants|Standard Deviation|Mean
2565129|NCT02602080|Secondary|Opioid Dose Among Patients Receiving Opioids in the PACU|Total opioid dose taken by patients who took any opioids in the PACU, measured in oral morphine equivalents (mg OME)|Duration of PACU stay (Average 2 hours)||||mg OME||Inter-Quartile Range|Mean
2565130|NCT02602080|Secondary|Patients Receiving Opioids in the PACU|Yes/no for patients that were given opioids for pain management in the PACU. If opioids were consumed, the oral morphine equivalents for the patients taking opioids was totaled.|PACU stay before discharge (average 2 hours)||||Participants|||Count of Participants
2565131|NCT02602080|Secondary|Number of Participants Satisfied With Anesthesia|Lowest satisfaction score on a 11 grade Likert scale (0=no satisfaction, 10=maximal satisfaction).|PACU before discharge, an average of 2 hours||||score on a scale||Inter-Quartile Range|Mean
2565132|NCT02602080|Secondary|Number of Participants With Emesis|Yes/no question. If yes, the investigators will then seek intensity of emesis|Average 2 hours after surgery (at discharge from the recovery room after surgery)||||Participants|||Count of Participants
2565133|NCT02602080|Secondary|Number of Participants With Emesis|Yes/no question. If yes, the investigators will then seek intensity of emesis|1 hour after surgery||||Participants|||Count of Participants
2565134|NCT02602080|Secondary|Antiemetic Consumption|Yes/no question if antiemetic consumption occured.|Duration of stay in recovery room after surgery (average 2 hours)||||Participants|||Count of Participants
2565135|NCT02602080|Primary|Intensity of Nausea|On a 11 grade Likert scale (0=no nausea, 10=worst possible nausea)|2 hours after surgery|Patients receiving either block+spinal+sedation for foot and ankle surgery or block+general or block+sedation for total shoulder arthroscopy|||Participants|||Count of Participants
2565136|NCT02602080|Primary|Intensity of Nausea|On an 11 grade Likert scale (0=no nausea, 10=worst possible nausea)|1 hour after surgery||||Participants|||Count of Participants
2565137|NCT02602080|Primary|Number of Participants With Nausea|Yes/no question. If yes, the investigators will then seek intensity of nausea.|Average 2 hours after surgery (at discharge from the recovery room after surgery)|Patients receiving either block+spinal+sedation for foot and ankle surgery or block+general or block+sedation for total shoulder arthroscopy|||Participants|||Count of Participants
2565138|NCT02602080|Primary|Number of Participants With Nausea 1 Hour After Post-anesthesia Care Unit (PACU) Admission|Yes/no response to whether patient had nausea in the PACU 1 hour after admission. If yes, investigators will seek out intensity|1 hour after surgery|Patients receiving either block+spinal+sedation for foot and ankle surgery or block+general or block+sedation for total shoulder arthroscopy|||Participants|||Count of Participants
2565139|NCT02601976|Other Pre-specified|Mean of Physical Component Score & Mental Component Score to Determine Quality of Life|To determine and compare the changes in quality of life (QOL) from baseline to end of the treatment. Health-Related Quality of Life (HRQOL) Questionnaire (SF-36) was used to measure the quality of life. The SF-36 is a widely used questionnaire, and consists of 36 questions measuring eight concepts: Physical Function (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Function (SF), Role Emotional (RE), and Mental Health (MH). The scoring of the SF-36 questionnaire in our study was conducted upon a 0-100 scale, with higher scores reflecting better health status.|Upto 48 weeks||||score on a scale||Standard Deviation|Mean
2565140|NCT02601976|Other Pre-specified|Number of Participants With Rapid Virological Response (RVR)|To evaluate the Rapid Virological Response (RVR) of all patients treated with PegInterferon Alfa-2a plus Ribavirin at 4 weeks of treatment|4 weeks||||Participants|||Count of Participants
2565141|NCT02601976|Secondary|Number of Participants Who Reported Adverse Events|To determine the number of patients treated with PegInterferon Alfa-2a plus Ribavirin who experience any adverse drug reaction. All ADR are reported as per patient information leaflet|Upto 48 weeks||||Participants|||Count of Participants
2565142|NCT02601976|Primary|Number of Participants With End Treatment Response|To determine the End Treatment Response (ETR) rate of all patients treated with PegInterferon alfa-2a plus Ribavirin|Upto 48 weeks||||Participants|||Count of Participants
2565143|NCT02601976|Primary|Number of Participants With Sustained Virological Response (SVR)|To determine the SVR at 24 weeks after completion of treatment, among those who achieved ETR|Post treatment Week 24|Among those who achieved ETR (i.e. 56 participants) were eligible for SVR analysis after 24 weeks of post treatment.|||Participants|||Count of Participants
2565281|NCT02599766|Secondary|Negative Emotional Display|Emotional display is assessed via video coding in Noldus Observer. Percentage of the defined behavior during the therapy sessions is collected and aggregated to one measure of negative emotion.|6 weeks||||percentage of negative emotion||Standard Deviation|Mean
2565144|NCT02601820|Secondary|Change in HCV-PRO Mean Score From Baseline to 1 Year Post-treatment|"HCV-specific Functional Well-Being was measured using the disease-specific HCV-PRO. The scale includes 16 items that measure physical, emotional and social functioning, productivity, intimacy, and perception of quality of life.~The Means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T5 HCV-PRO mean score.~Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.~HCV-PRO mean change scores could range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes.~To aid in interpretation of clinically significant change, a >5% change from baseline was set as the minimally important change (MIC) threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful."|Baseline to 1 year post-treatment|1430 of 1601 patients had post-treatment HCV RNA available to determine SVR status: 1362 achieved SVR, 68 did not. SVR data were missing on 171 patients. Of 1430, T5 records were missing for 93 cases (1337 remaining). Of the remaining 1337 records, HCV-PRO data were missing for 156 patients (1181 remaining: 1132 with SVR, 49 with no SVR)|||units on a scale||95% Confidence Interval|Mean
2565145|NCT02601820|Secondary|Changes in HCV Symptom Mean Scores From Baseline to 1 Year Post-Treatment|"Change in Symptoms was measured using surveys below. Change scores were calculated as baseline mean minus T5 mean. Lower change scores (-) indicate symptom improved~PROMIS Fatigue mean change score range = +/- 53.9~PROMIS Sleep Disturbance mean change score range = +/- 47.1~PROMIS Nausea mean change score range = +/- 44.0~PROMIS Diarrhea mean change score range = +/- 42.8~PROMIS Anger mean change score range = +/- 50.5.~PROMIS Anxiety mean change score range = +/- 41.4~PROMIS Depression mean change score range = +/- 43.1~PROMIS Cognitive Concern mean change score range = +/- 39.5~PROMIS Pain mean change score range = +/- 36.4~PROMIS Belly Pain mean change score range = +/- 50.2~Headache HIT-6 mean change score range = +/- 42 A 5% change from baseline is considered the clinically minimally important change (MIC). The 5% MIC = +/- 2.5 points.~Change scores were calculated for two subgroups: Patients who did and did not achieve SVR"|Baseline to 1 year post-treatment|1430 patients had post-treatment HCV RNA available to determine SVR status: 1362 achieved SVR, 68 did not. SVR data were missing on 171 patients. T5 records were missing for 93 cases. Discrepancies from 1362 and 68 due to missing survey data at T5 for specific measure.|||units on a scale||95% Confidence Interval|Mean
2565146|NCT02601820|Secondary|Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 1 Year Post-Treatment|"Change in Overall Symptom Burden from Baseline to 1 year post-treatment was measured using the Memorial Symptom Assessment Scale (MSAS). The total Overall Symptom Burden mean change score (TMSAS) was calculated as Baseline TMSAS mean score minus T5 TMSAS mean score.~Lower scores (-) indicate better outcomes. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.~TMSAS Mean Change Scores could range from +/- 4. To aid in interpretation of clinically significant change, a >5% change from baseline was set as the minimally important change (MIC) threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful"|Baseline to 1 year post-treatment|1430 of 1601 patients had post-treatment HCV RNA available to determine SVR status: 1362 achieved SVR, 68 did not. SVR data were missing on 171 patients. Of 1430, T5 records were missing for 93 cases (1337 remaining). Of the remaining 1337 records, TMSAS data were missing for 17 patients (1320 remaining: 1269 with SVR, 51 with no SVR)|||units on a scale||95% Confidence Interval|Mean
2565147|NCT02601820|Secondary|Change in HCV-PRO Mean Score From Baseline to 3-months Post Treatment|"HCV-specific Functional Well-Being was measured using the disease-specific HCV-PRO.~The means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T4 HCV-PRO mean score. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.~HCV-PRO Mean Change Scores could range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes.~To aid in interpretation of clinically significant change, a >5% change from baseline was set as the minimally important change (MIC) threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful."|Baseline to 3-months post-treatment|Of 1601 patients enrolled, 1430 patients had post-treatment HCV RNA available to determine SVR status. Of these, 1362 achieved SVR, 68 did not achieve SVR. SVR data were missing on 171 patients. Additional missing numbers due to missing HCV-PRO survey data at 3-months post-treatment.|||units on a scale||95% Confidence Interval|Mean
2565148|NCT02601820|Secondary|Change in HCV Symptom Mean Scores From Baseline to 3-months Post Treatment|"Change in Symptoms was measured using surveys below. Change scores were calculated as baseline mean minus T4 mean. Lower change scores (-) indicate symptom improved~PROMIS Fatigue mean change score range = +/- 53.9~PROMIS Sleep Disturbance mean change score range = +/- 47.1~PROMIS Nausea mean change score range = +/- 44.0~PROMIS Diarrhea mean change score range = +/- 42.8~PROMIS Anger mean change score range = +/- 50.5.~PROMIS Anxiety mean change score range = +/- 41.4~PROMIS Depression mean change score range = +/- 43.1~PROMIS Cognitive Concern mean change score range = +/- 39.5~PROMIS Pain mean change score range = +/- 36.4~PROMIS Belly Pain mean change score range = +/- 50.2~Headache HIT-6 mean change score range = +/- 42 A 5% change from baseline is considered the clinically minimally important change (MIC). The 5% MIC = +/- 2.5 points.~Change scores were calculated for two subgroups: Patients who did and did not achieve SVR"|Baseline to 3-months post-treatment|Of 1601 patients enrolled, 1430 patients had post-treatment HCV RNA available to determine SVR status. Of these, 1362 achieved SVR, 68 did not achieve SVR. SVR data were missing on 171 patients. Missing numbers below are due to missing PRO survey data at T4.|||units on a scale||95% Confidence Interval|Mean
2565157|NCT02601625|Primary|Safety: Summary of Erythema Injection Site Reaction (SC Cohorts) Assessed in Participants|Erythema was measured as the largest diameter across the needle site on the skin in millimetres (mm). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average of the two injection site diameters (mm) were reported.|Immediately after dosing, at 10, 20 minutes and 1 hour after injection|The safety analysis set included all participants who received at least 1 dose of IMP (anifrolumab or placebo) and for whom any safety post-dose data were available.|||Millimeter||Standard Deviation|Mean
2565282|NCT02599766|Secondary|Positive Emotional Display|Emotional display is assessed via video coding in Noldus Observer. Percentage of the defined behavior during the therapy sessions is collected and aggregated to one measure of positive emotion.|6 weeks||||percentage of positive emotion||Standard Deviation|Mean
2565149|NCT02601820|Secondary|Change in Total Memorial Symptom Assessment Scale (TMSAS) Mean Score From Baseline to 3-months Post Treatment|"Change in Overall Symptom Burden from Baseline to 3-months post-treatment was measured using the Memorial Symptom Assessment Scale (MSAS).~The total Overall Symptom Burden mean change score (TMSAS) was calculated as Baseline TMSAS mean score minus T4 TMSAS mean score.~Lower scores (-) indicate better outcomes. Change scores were calculated for two subgroups: (1) Patients who achieved SVR and (2) patients who did not achieve SVR.~TMSAS Mean Change Scores could range from +/- 4.~To aid in interpretation of clinically significant change, a >5% change from baseline was set as the minimally important change (MIC) threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful."|Baseline to 3-months post-treatment|Of 1601 patients enrolled, 1430 patients had post-treatment HCV RNA available to determine SVR status. Of these, 1362 achieved SVR, 68 did not achieve SVR. SVR data were missing on 171 patients. Additional missing numbers (from 1362 to 1313 and 68 to 58) were due to missing MSAS survey data at 3-months post-treatment.|||units on a scale||95% Confidence Interval|Mean
2565150|NCT02601820|Secondary|Percentage of Participants With Nonadherence During HCV Treatment|Medication adherence was measured using the Voils' Medication Adherence Survey (VMAS). The VMAS consists of 3 items that evaluated the extent of adherence using a 5-point Likert scale from 1=None of the time to 5=All of the time. The 3 items assess how often participants missed doses, skip doses, or do not take doses over the past 7 days and are averaged into a single score. A dichotomous variable was created to categorize patients as 100% (adherent) or <100% (nonadherent) during HCV treatment at early treatment (T2) and late treatment (T3).|Up to 24 weeks of HCV Treatment|Of 1601 enrolled patients, 1562 had VMAS adherence data at either early treatment (T2) or late treatment (T3). 1513 patients had adherence data at T2. 1476 patients had adherence data at T3.|||percentage of participants||95% Confidence Interval|Number
2565151|NCT02601820|Secondary|Cumulative Out of Pocket Costs During HCV Treatment|"Cumulative out of pocket (OOP) costs incurred by patients during HCV treatment was measured by a survey recording 5 direct and 5 indirect costs of treatment. OOP costs were collected early on-treatment (T2), late on-treatment (T3), and early post-treatment (T4) in case patients paid bills after treatment ended.~The Mean is the average dollar ($$) amount for Total OOP Cost of HCV Treatment for the cohort, calculated by summing the OOP costs for each patient reported at T2+T3+T4."|Up to 24 weeks of HCV Treatment|Of 1601 patients enrolled, OOP cost data was recorded by 1578 patients. Due to unreliable data, especially at the upper limit, 40 cases (2.53%) were eliminated from each tail (lower and upper limit), totaling 80 cases (5.06%) of the 1578 sample. OOP dollar amount below based on 1498 cases.|||units on a scale||95% Confidence Interval|Mean
2565152|NCT02601820|Secondary|Change in HCV-PRO Mean Scores From Baseline to On-Treatment|"HCV-specific Functional Well-Being was measured using the disease-specific HCV-PRO. The scale includes 16 items that measure physical, emotional and social functioning, productivity, intimacy, and perception of quality of life.~The Means provided are the HCV-PRO Mean Change Scores, calculated as Baseline HCV-PRO mean score minus T2 HCV-PRO mean score or Baseline HCV-PRO mean score minus T3 HCV-PRO mean score.~HCV-PRO mean change scores range from +/- 100. Higher change scores (+) indicate better HCV-PRO outcomes.~To aid in interpretation of clinically significant change, a >5% change from baseline was set as the minimally important change (MIC) threshold. A 5% change in HCV-PRO = 4 points; therefore HCV-PRO change scores > +/- 4.0 were considered clinically meaningful."|Baseline to up to 24 weeks of HCV Treatment|"Of 1533 patients with data records at T2, 1346 had analyzable HCV-PRO data at T2.~Of 1524 patients with data records at T3, 1356 had analyzable HCV-PRO data at T3. Discrepancies due to missing HCV-PRO data."|||units on a scale||95% Confidence Interval|Mean
2565153|NCT02601820|Secondary|Change in Treatment-Related Symptom Mean Scores From Baseline to On-Treatment|"Change in Treatment-Related Symptoms was measured using multiple surveys from the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) and the Headache Impact Test (HIT-6). Mean CHANGE Scores were calculated as baseline mean score minus T2 mean score or baseline mean score minus T3 mean score. Lower change scores (-) indicate symptoms improved.~PROMIS Fatigue-7 mean change score range = +/- 53.9~PROMIS Sleep Disturbance-8a mean change score range = +/- 47.1~PROMIS Nausea/Vomiting-4 mean change score range = +/- 44.0~PROMIS Diarrhea-6 mean change score range = +/- 42.8~PROMIS Anger-5 mean change score range = +/- 50.5.~PROMIS Anxiety-4 mean change score range = +/- 41.4~HIT-6 mean change score range = +/- 42~To aid in interpretation of clinical significance, a 5% change from baseline is considered a minimally important change (MIC). The 5% MIC change in a PROMIS or HIT-6 score is +/- 2.5 points."|Baseline to up to 24 weeks of HCV Treatment|Sample size may differ for each mean change score due to missing survey data.|||units on a scale||95% Confidence Interval|Mean
2565154|NCT02601820|Primary|Change in the Total Memorial Symptom Assessment Scale Mean Score (TMSAS) From Baseline to On-Treatment|"Change in Overall Symptom Burden was measured using the Memorial Symptom Assessment Scale (MSAS). Patients indicate the presence or absence of a symptom, and if present, rate the symptom on severity, frequency and interference. The total MSAS score (TMSAS) can range from 0 (no symptom) to 4 (symptom present and worst severity, frequency and distress). Change in TMSAS score is calculated as Baseline TMSAS mean score minus T2 TMSAS mean score or Baseline TMSAS mean score minus T3 TMSAS mean score.~Change scores could range from +/- 4.0. Higher scores (+) indicate worse symptom burden.~To aid in interpretation of clinically significant change, a >5% change from baseline was set as the minimally important change (MIC) threshold. A 5% change in the TMSAS = 0.3 points; therefore TMSAS change scores > +/- 0.3 were considered clinically meaningful."|Baseline to up to 24 weeks of HCV Treatment|"Of 1533 patients with complete record at T2, 1517 provided sufficient TMSAS data to calculate change score.~Of 1524 patients with complete record at T3, 1513 provided sufficient TMSAS data to calculate change score.~Discrepancies due to missing TMSAS data at T2 or T3."|||units on a scale||95% Confidence Interval|Mean
2565155|NCT02601625|Primary|Safety: Summary of the Induration Injection Site Reaction (SC Cohorts) Assessed in Participants|Induration was measured as the largest diameter across the needle site on the skin in millimetres (mm). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average of the two injection site diameters (mm) were reported.|Immediately after dosing, at 10, 20 minutes and 1 hour after injection|The safety analysis set included all participants who received at least 1 dose of IMP (anifrolumab or placebo) and for whom any safety post-dose data were available.|||Millimeter||Standard Deviation|Mean
2565158|NCT02601625|Primary|Safety: Summary of Local Injection Site Pruritus (SC Cohorts) Assessed in Participants|"Local injection site pruritus was assessed using a 100 mm participant rated Visual Analog Scale (VAS 0mm - 100mm ungraduated scale, where 0 = no itching to 100 = worst imaginable itching). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average VAS score (0mm-100mm) of the two injection sites were reported."|Immediately after dosing, at 10, 20 minutes and 1 hour after injection|The safety analysis set included all participants who received at least 1 dose of IMP (anifrolumab or placebo) and for whom any safety post-dose data were available.|||Millimeter||Standard Deviation|Mean
2565159|NCT02601625|Primary|Safety: Summary of Local Injection Site Pain (SC Cohorts) Assessed in Participants|"Local injection site pain was assessed using a 100 mm participant rated Visual Analog Scale (VAS 0mm - 100mm ungraduated scale, where 0 = no pain to 100 = worst imaginable pain). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average VAS score (0mm-100mm) of the two injection sites were reported."|Immediately after dosing, at 10, 20 minutes and 1 hour after injection|The safety analysis set included all participants who received at least 1 dose of IMP (anifrolumab or placebo) and for whom any safety post-dose data were available.|||Millimeter||Standard Deviation|Mean
2565160|NCT02601625|Primary|Safety: Number of Participants With Adverse Events (AEs)|To assess the safety and tolerability of single doses of anifrolumab|From screening to final follow-up visit, up to 16 weeks|The safety analysis set included all participants who received at least 1 dose of investigational medicinal product (IMP) (anifrolumab or placebo) and for whom any safety post-dose data were available.|||Participants|||Number
2565161|NCT02601625|Primary|Pharmacokinetics: Area Under Serum Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC) Following Single Dose of Anifrolumab|"To evaluate AUC of anifrolumab after single administration of two doses subcutaneously and one dose intravenously.~Up to 13 blood samples were collected in total."|On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days|The PK analysis set consisted of all participants in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations that had an impact on the analysis of the PK data|||day*μg/mL||Standard Deviation|Mean
2565162|NCT02601625|Primary|Pharmacokinetics: Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) Following Single Dose of Anifrolumab|"To evaluate AUC(0-t) of anifrolumab after single administration of two doses subcutaneously and one dose intravenously~Up to 13 blood samples were collected in total."|On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days|The PK analysis set consisted of all participants in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations that had an impact on the analysis of the PK data|||day*μg/mL||Standard Deviation|Mean
2565163|NCT02601625|Primary|Pharmacokinetics: Observed Maximum Serum Concentration (Cmax) Following Single Dose of Anifrolumab.|"To evaluate Cmax of anifrolumab after single administration of two doses subcutaneously and one dose intravenously.~Up to 13 blood samples were collected in total."|On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days|The pharmacokinetic (PK) analysis set consisted of all participants in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations that had an impact on the analysis of the PK data|||ug/mL||Standard Deviation|Mean
2565164|NCT02601573|Secondary|Percentage of Participants Achieving SVR24 (Sustained Virologic Response 24 Weeks After the End of All Study Therapy)|The percentage of participants achieving SVR24 (i.e., HCV RNA < LLOQ 24 weeks after completing study treatment) was determined. Plasma HCV RNA levels were determined with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.|Up to Week 40|All randomized participants who received at least 1 dose of study drug, were not lost to follow-up for reasons unrelated to study treatment, and had SVR24 data available are included.|||Percentage of Participants||95% Confidence Interval|Number
2565165|NCT02601573|Primary|Percentage of Participants Discontinuing From Study Therapy Due to an AE|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 16 weeks|All participants who received at least 1 dose of study drug are included.|||Percentage of Participants|||Number
2565166|NCT02601573|Primary|Percentage of Participants Experiencing an Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 18 weeks (up to 2 weeks after completion of study treatment)|All participants who received at least 1 dose of study drug are included.|||Percentage of Participants|||Number
2565167|NCT02601573|Primary|Percentage of Participants Achieving SVR12 (Sustained Virologic Response 12 Weeks After the End of All Study Therapy)|The percentage of participants achieving SVR12 (i.e., HCV ribnonucleic acid [RNA] < Lower Limit of Quantification [LLOQ] 12 weeks after completing study treatment) was determined. Plasma HCV RNA levels were determined with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL.|Up to Week 28|All randomized participants who received at least 1 dose of study drug, were not lost to follow-up for reasons unrelated to study treatment, and had SVR12 data available are included.|||Percentage of Participants||95% Confidence Interval|Number
2565168|NCT02601560|Secondary|Number of Participants With Positive Anti-Drug Antibodies for MEDI6012|Participants were tested for immunogenicity to MEDI6012. The neutralization assay measures the capacity of participant's plasma (antibodies) to inhibit the binding of MEDI6012 to its target.|Day 1 (pre-dose), 15, 29 and 57|Immunogenicity population: All participants in the as-treated population with at least one serum sample available for immunogenicity testing.|||Participants|||Count of Participants
2565283|NCT02599766|Secondary|Social Functioning: Attention|Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of the defined attention behavior is collected and aggregated to one measure.|6 weeks||||percentage of attention||Standard Error|Mean
2565169|NCT02601560|Secondary|Elimination Half Life (t1/2) of MEDI6012|The t1/2 is the time measured for the plasma concentration to decrease by one half.|Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)|PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (<2.5 mcg/mL).|||hrs||Standard Deviation|Mean
2565170|NCT02601560|Secondary|Area Under the Concentration Time Curve to Infinite Time (AUC [0-inf]) of MEDI6012|The area under the concentration-time curve to infinite time of MEDI6012.|Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)|PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (<2.5 mcg/mL).|||mcg*hr/mL||Standard Deviation|Mean
2565171|NCT02601560|Secondary|Area Under the Concentration Time Curve From Time Zero to Last Quantifiable Concentration (AUC [0-last]) of MEDI6012|Area under the plasma concentration time-curve from zero to the last measured concentration (AUC [0-last]) of MEDI6012.|Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)|PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (<2.5 mcg/mL).|||mcg*hr/mL||Standard Deviation|Mean
2565172|NCT02601560|Secondary|Area Under the Concentration Time Curve From 0 to 168 Hrs (AUC [0-168]) of MEDI6012|The area under the concentration-time curve from 0 to 168 hrs of MEDI6012.|Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)|PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (<2.5 mcg/mL).|||mcg*hr/mL||Standard Deviation|Mean
2565173|NCT02601560|Secondary|Time to Reach Concentration Maximum (Tmax) of MEDI6012|The time at which Cmax of MEDI6012 was observed determined directly from raw concentration time data.|Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)|PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (<2.5 mcg/mL).|||hrs||Full Range|Median
2565174|NCT02601560|Secondary|Maximum Observed Serum Concentration (Cmax) of MEDI6012|The first occurrence of the maximum observed plasma concentration of MEDI6012 determined directly from the raw concentration time data.|Pre-dose and within 5 minutes; 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hrs post-dose Day 1 for IV and SC dose, Day 15 and Day 29; additional 30 min after start of 1-hour infusion (IV cohorts only)|PK population. PK data of MEDI6012 80 mg SC dose group was not interpretable as concentration levels were predominantly beneath the limit of quantitation (<2.5 mcg/mL).|||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
2565175|NCT02601560|Secondary|Change From Baseline in Serum Concentration of Lecithin-Cholesterol Acyltransferase (LCAT) at Day 57|The change from baseline in serum concentration of lecithin-cholesterol acyltransferase was estimated.|Baseline (Day 1) and Day 57|Pharmacokinetic (PK) population: All participants in the as-treated population who had atleast one detectable LCAT serum concentration measurement.|||mcg/mL||Standard Deviation|Mean
2565176|NCT02601560|Secondary|Change From Baseline in Serum Concentration of Pre Beta 1-High Density Lipoprotein at Day 29|The change from baseline in serum concentration of pre beta 1-high density lipoprotein was estimated.|Baseline (Day 1) and Day 29|As-treated population.|||mg/dL||Standard Deviation|Mean
2565177|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) Post Dose for Apolipoprotein B|The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of apolipoprotein B.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
2565178|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Low Density Lipoprotein-Cholesterol (Direct)|The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of low density lipoprotein cholesterol (direct).|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
2565179|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Unesterified Cholesterol|The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein unesterified cholesterol.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
2565180|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesteryl Ester|The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein cholesteryl ester.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
2565181|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Unesterified Cholesterol|The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of high density lipoprotein unesterified cholesterol.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
2565247|NCT02600715|Primary|Change in Bladder Injection Pain|The primary outcome will be calculated difference in numeric rating scale (NRS) pain score prior to procedure and midway through procedure. Scale is one question and has a range from a score of 0 (no pain) to 10 (worst possible pain). Measure will be reported as the intraoperative pain score minus the preoperative pain score.|Baseline and intraoperative||||units on a scale||Inter-Quartile Range|Median
2565182|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Non-High Density Lipoprotein Cholesterol|The AUC(0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of non-high density lipoprotein cholesterol.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
2565183|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for High-Density Lipoprotein Cholesteryl Ester|The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of high density lipoprotein cholesteryl ester.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
2565184|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Cholesteryl Ester|The AUC(0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of cholesteryl ester.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
2565185|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Free Cholesterol|The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of free cholesterol.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
2565186|NCT02601560|Secondary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hrs (AUC [0-96 Hrs]) for Total Cholesterol|The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of total cholesterol.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion and 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated population|||mg/dL||Standard Deviation|Mean
2565187|NCT02601560|Primary|Baseline-adjusted Area Under the Curve From Time 0 to 96 Hours (Hrs) (AUC [0-96 Hrs]) for High-Density Lipoprotein-Cholesterol (HDL-C)|The AUC (0-96 hrs) is the area under the concentration-time curve from time 0 to 96 hrs of HDL-C.|Pre-dose, 12, 24, 48, 72 and 96 hrs post-dose Day 1 for IV and SC dose; additional within 5 minutes after completion of infusion, 4 and 8 hrs post-dose Day 1 (IV cohorts only)|As-treated Population.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2565188|NCT02601560|Primary|Number of Participants With TEAEs Related to Clinical Laboratory Evaluations|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.|Baseline (Day 1) up to Day 57|As-treated Population|||Participants|||Count of Participants
2565189|NCT02601560|Primary|Number of Participants With TEAEs Related to Vital Sign Parameters|TEAEs observed in participants with clinically significant vital signs abnormalities were assessed. Vital signs parameters included blood pressure, respiration rate, pulse, pulse oximetry, and body temperature.|Baseline (Day 1) up to Day 57|As-treated Population|||Participants|||Count of Participants
2565190|NCT02601560|Primary|Number of Participants With TEAEs Related to Electrocardiogram (ECG) Evaluations|TEAEs observed in participants with clinically significant ECG abnormalities were assessed. TEAEs are the events between first dose of study drug and up to 57 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline (Day 1) up to Day 57|As-treated Population|||Participants|||Count of Participants
2565191|NCT02601560|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are the events between first dose of study drug and up to 57 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline (Day 1) up to Day 57|As-treated Population: All participants who received any amount of study drug were included in this population.|||Participants|||Count of Participants
2565192|NCT02601469|Primary|Number of Participants With HPA Axis Suppression|Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of ≤ 18 mcg/100ml.|28 days||||Participants|||Count of Participants
2565193|NCT02601300|Secondary|The Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE)|A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of mongersen and up to 28 days after the last mongersen dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain.|From the first day of mongersen until 28 days after the last dose of IP or at follow-up visit, whichever occurred earlier; maximum duration of treatment was 56 weeks|Safety population included all participants who were enrolled and received at least 1 dose of IP.|||Participants|||Count of Participants
2565212|NCT02601209|Secondary|The Number of Patients Who Experienced Grade 3+ Adverse Events (Phase II Analysis Group 2 - Initial Treatment Period)|The number of patients who experienced grade 3+ adverse events for Phase II Analysis Group 2 for the initial treatment period is reported below.|Up to 4 months|Phase II Analysis Group 2 - Initial Treatment Period; This analysis excludes cancel patients (who never received treatment i.e. Withdrew before initiation of regimen )|||Participants|||Count of Participants
2565194|NCT02601300|Secondary|Percentage of Participants Who Achieved a Clinical Response in the Total Mayo Score at Week 8|"Clinical response in the TMS was defined as a decrease from baseline in the TMS of ≥ 3 points and ≥ 30%, along with a reduction in the RBS of ≥ 1 point or an absolute RBS of ≤ 1 at Week 8. The TMS is an instrument designed to measure disease activity of ulcerative colitis. The TMS ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease.~Stool frequency subscore~Rectal bleeding subscore~Endoscopic subscore~Physician's Global Assessment"|Baseline to Week 8|The intent to treat population included all participants who received at least one dose of IP. The primary approach to handling missing data was NRI method, where participants who had insufficient data for response determination at Week 8 were considered non-responders for Total Mayo score.|||percentage of participants||95% Confidence Interval|Number
2565195|NCT02601300|Secondary|Percentage of Participants Who Achieved a Clinical Remission in the Total Mayo Score (TMS) at Week 8|"Clinical remission in total Mayo score was defined as a total Mayo score of ≤ 2, with no individual subscore >1. The TMS is an instrument designed to measure disease activity of ulcerative colitis. The TMS ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease.~Stool frequency subscore (SFS)~Rectal bleeding subscore (RBS)~Endoscopic subscore~Physician's Global Assessment (PGA)"|Baseline to Week 8|The intent to treat population included all participants who received at least one dose of IP. The primary approach to handling missing data was NRI method, where participants who had insufficient data for response determination at Week 8 were considered non-responders for Total Mayo score.|||percentage of participants||95% Confidence Interval|Number
2565196|NCT02601300|Secondary|Percentage of Participants Who Achieved a Mayo Endoscopic Response at Week 8|"Endoscopic response was defined as a decrease from baseline of at least 1 point in the Mayo endoscopic subscore. The Mayo endoscopy subscore findings are defined as:~0 = Normal or inactive disease~= Mild Disease (erythema, decreased vascular pattern, mild friability)~= Moderate Disease (marked erythema, lack of vascular pattern, friability erosions)~= Severe Disease (spontaneous bleeding, ulceration) The endoscopy subscores were centrally reviewed. Two-sided 95% CIs for the within-group percentage were based on the Wilson score method."|Baseline and Week 8|The intent to treat population included all participants who received at least one dose of IP. The primary approach to handling missing data was NRI method, where participants who had insufficient data for response determination at Week 8 were considered non-responders for Mayo endoscopic response.|||percentage of participants||95% Confidence Interval|Number
2565197|NCT02601300|Secondary|Percentage of Participants Who Achieved a Clinical Response in the Modified Mayo Score at Week 8|"Clinical response in the MMS was defined as a decrease from baseline in the MMS of at least 2 points and at least 25%, along with a reduction in the RBS of at least 1 point or an absolute RBS ≤ 1. The MMS was based on the stool frequency, rectal bleeding, and endoscopic subscores of the TMS and excluded the PGA subscore. The MMS ranges from 0 to 9 points with higher scores indicating greater disease severity. The RBS was defined as:~0 = No blood seen~= Streaks of blood with stool less than half the time~= Obvious blood with stool most of the time~= Blood alone passes The daily bleeding score represents the most severe bleeding score represents the most severe bleeding of the day."|Baseline to Week 8|The intent to treat population included all participants who received at least one dose of IP. The primary approach to handling missing data was NRI method, where participants who had insufficient data for response determination at Week 8 were considered non-responders for MMS.|||percentage of participants||95% Confidence Interval|Number
2565198|NCT02601300|Secondary|Percentage of Participants Who Achieved a Mayo Endoscopic Subscore of ≤ 1 by Individual Segment at Week 8|"A Mayo endoscopic subscore by individual segment (rectum, sigmoid, descending colon, transverse colon, ascending colon/cecum) of ≤ 1 was evaluated at week 8.~The endoscopy subscore findings are defined as:~0 = Normal or inactive disease~= Mild Disease (erythema, decreased vascular pattern, mild friability)~= Moderate Disease (marked erythema, lack of vascular pattern, friability erosions)~= Severe Disease (spontaneous bleeding, ulceration) The endoscopy scores were centrally reviewed. Two-sided 95% CIs for the within-group percentage were based on the Wilson score method."|Baseline to Week 8|The intent to treat population included all participants who received at least one dose of IP. Only participants with sufficient data for response determination in each segment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2565199|NCT02601300|Secondary|Percentage of Participants Who Achieved a Mayo Endoscopic Subscore of ≤ 1 at Week 8|"A Mayo endoscopic subscore of ≤ 1 was assessed and evaluated in participants who achieved a Mayo endoscopic subscore at Week 8. The endoscopy subscore findings are defined as:~0 = Normal or inactive disease~= Mild Disease (erythema, decreased vascular pattern, mild friability)~= Moderate Disease (marked erythema, lack of vascular pattern, friability erosions)~= Severe Disease (spontaneous bleeding, ulceration) The endoscopy scores were centrally reviewed. Two-sided 95% CIs for the within-group percentage were based on the Wilson score method."|Baseline to Week 8|The intent to treat population included all participants who received at least one dose of IP. The primary approach to handling missing data was NRI method, where participants who had insufficient data for response determination at Week 8 were considered non-responders for Mayo Endoscopic Subscore.|||percentage of participants||95% Confidence Interval|Number
2565200|NCT02601300|Secondary|Percentage of Participants Who Achieved a Modified Mayo Score of ≤ 2, With Rectal Bleeding Subscore (RBS) of 0 and Stool Frequency Subscore (SFS) and Mayo Endoscopic Subscore ≤ 1 at Week 8|"A MMS was used to evaluate disease activity using 3 components: stool frequency, rectal bleeding and endoscopy; the MMS ranges from 0-9 with higher scores indicating greater disease severity.~Stool frequency subscore was defined as 0-3:~0 = Normal number of stools for patient~= 1-2 stools per day more than normal~= 3-4 stools more than normal~= 5 or more stools more than normal~Rectal bleeding (subscore 0-3) was defined as:~0 = No blood seen~= Streaks of blood with stool less than half the time~= Obvious blood with stool most of the time~= Blood alone passes~Endoscopic subscore: Findings were defined as:~0 = Normal or inactive disease~= Mild Disease (erythema, decreased vascular pattern, mild friability)~= Moderate Disease (marked erythema, lack of vascular pattern, friability erosions)~= Severe Disease (spontaneous bleeding, ulceration)"|Baseline to Week 8|The intent to treat population included all participants who received at least one dose of IP. The primary approach to handling missing data was NRI method, where participants who had insufficient data for response determination at Week 8 were considered non-responders for the MMS response.|||percentage of participants||95% Confidence Interval|Number
2565201|NCT02601300|Primary|Percentage of Participants Who Achieved Clinical Remission in the Modified Mayo Score (MMS) at Week 8|Clinical remission was defined as a modified Mayo score of ≤ 2, with no individual subscore > 1, at Week 8. The MMS was based on a modification of the total Mayo score (TMS) which included the stool frequency, rectal bleeding, and endoscopic subscores of the TMS and excluded the Physician's Global Assessment (PGA) subscore, since this was a global measure that is subjective in nature. The MMS ranges from 0 to 9 points with higher scores indicating greater disease severity. The endoscopy subscores was centrally reviewed. Two-sided confidence intervals for the within-group percentage were based on the Wilson score method.|Baseline to Week 8|The intent to treat population included all participants who received at least one dose of IP. The primary approach to handing missing data was non-responder imputation (NRI) method, where participants who had insufficient data for response determination at Week 8 were considered non-responders for clinical remission.|||percentage of participants||95% Confidence Interval|Number
2565202|NCT02601209|Other Pre-specified|Cohort-specific Evaluation of 4-month Clinical Benefit Rate (CBR) (Phase II, Analysis Group II)|Analyses will be exploratory in nature.|4 months|||||||
2565203|NCT02601209|Other Pre-specified|Overall Survival (OS) in Crossover Patients (Phase II)|Kaplan-Meier methodology will be used to estimate the distribution of >>> OS.|Time between date the patient initiated sapanisertib and death due to any cause (or last contact for surviving patients and those lost to follow-up), assessed up to 2 years|||||||
2565204|NCT02601209|Other Pre-specified|Time to Progression (TTP) in Crossover Patients (Phase II)|Kaplan-Meier methodology will be used to estimate the distribution of >>> TTP.|Time between date the patient initiated sapanisertib and disease progression, assessed up to 2 years|||||||
2565205|NCT02601209|Other Pre-specified|Duration of Response in Crossover Patients (Phase II)|Will be analyzed using Kaplan-Meier methodology.|Time between each patient's best tumor response and progression >>> (or date of last disease assessment for patients who die without progression or are lost to follow-up), assessed up to 2 years|||||||
2565206|NCT02601209|Other Pre-specified|Progression-free Survival (PFS) (Phase II)|Defined as either disease progression or death (in cases where patients have died without evidence of disease progression) in crossover patients.|Up to 2 years|||||||
2565207|NCT02601209|Secondary|Overall Survival (OS) (Phase II Analysis Group 2 - Initial Treatment Period)|Overall survival (OS) (Phase II Analysis Group 2 - Initial Treatment Period). Kaplan-Meier methodology will be used to estimate the distribution of OS.|Time between randomization and death due to any cause (or last contact for surviving patients and those lost to follow-up), assessed up to 2 years|Phase II Analysis Group 2 - Initial Treatment Period|||months||95% Confidence Interval|Median
2565208|NCT02601209|Secondary|Time to Progression (TTP) (Phase II Analysis Group 2 - Initial Treatment Period)|Time to progression is defined as the time between randomization and disease progression. Kaplan-Meier methodology will be used to estimate the distribution of TTP. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion,b. At least a 20% increase in PBSD. c. PD via FDG-PET imaging. d. unequivocal progression of existing non-target lesions and non-target lymph nodes. e. Symptomatic deterioration.|Time between randomization and disease progression, assessed up to 2 years|Phase II Analysis Group 2 - Initial Treatment Period|||months||95% Confidence Interval|Median
2565209|NCT02601209|Secondary|Number of Patients Having CR, PR, or SD at 6 Months (Phase II Analysis Group 2 - Initial Treatment Period)|Will be defined as the number of patients having either complete response (CR), partial response (PR), or stable disease for at least 6 months after starting treatment. The frequencies and rates of tumor response categories (CR, PR, SD, PD, and too early/not evaluated) will be summarized by dose cohort and treatment arm. Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to < 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion,b. At least a 20% increase in PBSD. c. PD via FDG-PET imaging. d. unequivocal progression of existing non-target lesions and non-target lymph nodes. e. symptomatic deterioration. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the MSD.|Up to 6 months|Phase II Analysis Group 2 - Initial Treatment Period|||Participants|||Count of Participants
2565210|NCT02601209|Secondary|Duration of Response (Phase II Analysis Group 2 - Initial Treatment Period)|Duration of response is defined as the time between each patient's best tumor response and progression (or date of last disease assessment for patients who die without progression or are lost to follow-up). Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to < 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD.|Time between each patient's best tumor response and progression(or date of last disease assessment for patients who die without progression or are lost to follow-up), assessed up to 2 years|Phase II Analysis Group 2 - Initial Treatment Period; Only patients that had a complete response or partial response are included in this analysis.|||months||Full Range|Median
2565211|NCT02601209|Secondary|Tumor Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD], and Progressive Disease [PD])(Phase II Analysis Group 2 - Initial Treatment Period)|The frequencies (and percentages) of tumor response categories (CR, PR, SD, PD) will be summarized for Phase II Analysis Group 2. Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to < 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion, b. At least a 20% increase in PBSD. c. PD via FDG-PET imaging. d. unequivocal progression of existing non-target lesions and non-target lymph nodes. e. symptomatic deterioration. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the MSD.|Up to 2 years|Phase II Analysis Group 2 - Initial Treatment Period; Patients with tumor response data available are included in this analysis.|||Participants|||Count of Participants
2565240|NCT02600715|Secondary|Participant Satisfaction With Pain Control|Measured using one question Likert scale. This will be a 4-level scale ranging from 'not at all satisfied,' 'slightly satisfied,' 'mostly satisfied,' and 'very much satisfied.'|Postoperative (within 10 minutes of the end of the BoNT procedure)||||Participants|||Count of Participants
2565213|NCT02601209|Primary|Progression-free Survival (PFS) (Phase II Analysis Group 2 - Initial Treatment Period)|Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and an upper confidence boundary from a 1-sided, 85% confidence interval are estimated using the Kaplan-Meier methods.|Up to 2 years|Phase II Analysis Group 2 - Initial Treatment Period|||months||95% Confidence Interval|Median
2565214|NCT02601209|Primary|Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)|The Maximum Tolerated Dose (MTD) of sapanisertib (MLN0128) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. The number of patients reporting a dose-limiting event is reported.|28 days|Phase I|||Participants|||Count of Participants
2565215|NCT02600871|Secondary|Rate of New Lesion Development|New lesions, defined as a new abscess, pustule, carbuncle, or furuncle at least 5cm away from the initial wound, that developed in the subject within 30 days of enrollment|30 Days||||Participants|||Count of Participants
2565216|NCT02600871|Secondary|Infection Rates of Household Contacts|New lesions (abscess, pustule, carbuncle, or furuncle) that developed in household contacts of subjects within 30 days of enrollment|30 Days||||Participants|||Count of Participants
2565217|NCT02600871|Primary|Number of Participants With a Clinical Cure|Clinical cure was defined as improvement in the initial wound with respect to a decrease in measured size, erythema, and purulent discharge. Wound management at the follow up visits was left up to the discretion of the treating provider, but additional interventions for patients not clinically improving or worsening were considered a lack of clinical cure.|7-10 Days||||Participants|||Count of Participants
2565218|NCT02600845|Secondary|Percentage of Blood Glucose Tagged Data|Tagged data specifies the timing of blood glucose recording and includes: fasting, before breakfast, after breakfast, before lunch, after lunch, before dinner, after dinner, and bedtime. The percentage of blood glucose tagged data per interval was calculated as the total number of tagged blood glucose readings during the interval divided by the total number of readings within the interval.|Weeks 12 and 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||percentage||Standard Deviation|Mean
2565219|NCT02600845|Secondary|Change From Baseline in Mean Daily Self-Monitoring of Blood Glucose (SMBG) Frequency at Weeks 12 and 24|An increase in SMBG frequency indicates more glycemic control. The average number of daily SMBG measurements per interval was calculated based on the total number of blood glucose readings recorded during the study visit interval.|Baseline, Weeks 12 and 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||glucose checks per day||Standard Deviation|Mean
2565220|NCT02600845|Secondary|Change From Baseline in the Number of Blood Glucose Checks at Weeks 12 and 24|An increase in the number of blood glucose checks indicates more glycemic control.|Baseline, Weeks 12 and 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||blood glucose checks||Standard Deviation|Mean
2565221|NCT02600845|Secondary|Percent of Follow-Up Visits With Sufficient SMBG Data|Sufficient SMBG data is based on the ability of the healthcare provider to make informed decisions regarding therapy adjustments.|Up to Week 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||percentage of follow-up visits||Standard Deviation|Mean
2565222|NCT02600845|Secondary|Number of Participants With Competency in Self-monitoring of Blood Glucose (SMBG) at Week 24|Competency was defined as appropriate response to high and low glucose values.|Week 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||Participants|||Count of Participants
2565223|NCT02600845|Secondary|Incidence of Hypoglycemia|A hypoglycemic reading was defined as a glucose value that fell below the 70 mg/dL level. The incidence of hypoglycemia was defined as the number of hypoglycemic readings in the interval divided by the total number of blood glucose checks in the interval.|Baseline, Weeks 12 and 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||hypoglycemic readings||Standard Deviation|Mean
2565224|NCT02600845|Secondary|Change From Baseline to Week 24 in Glycemic Variability|Glycemic variability refers to swings in blood glucose levels. Mean glycemic variability is expressed as a standard deviation of blood glucose data. A negative number indicates a decrease in glucose variability. A positive number indicates and increase in glucose variability.|Baseline, Week 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2565225|NCT02600845|Secondary|Change From Baseline to Week 24 in Mean Blood Glucose Level|Blood glucose is a type of sugar in blood and is measured to assess a participant's control of diabetes.|Baseline, Week 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||milligrams per deciliter||Standard Deviation|Mean
2565226|NCT02600845|Secondary|Mean Change From Baseline to Week 24 in Percentage of Glucose Readings in Target Range|Glucose target range was specified as 70-180 milligrams per deciliter (mg/dL).|Baseline, Week 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||percent||Standard Deviation|Mean
2565227|NCT02600845|Secondary|Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24|Assessment of HbA1c is an indicator of long-term control of diabetes.|Baseline, Weeks 12 and 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||percent||Standard Deviation|Mean
2565228|NCT02600845|Secondary|Change From Baseline to Week 24 in Diabetes Distress Scale (DDS) Score|Participants rated their level of diabetes distress by answering 17 questions in in the following areas: Regimen-related Distress, Emotional Burden, Diabetes-related Interpersonal Distress and Physician-related Distress (PD) on a 6-point scale: 1=Not a problem to 6=A very serious problem. The Average Total score ranged from 1 (best) to 6 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline DDS, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.|Baseline, Week 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24. Data from evaluable participants are reported.|||score on a scale||95% Confidence Interval|Mean
2565229|NCT02600845|Primary|Treatment Satisfaction: Diabetes Treatment Satisfaction Questionnaire (DTSQc) Score at Week 24|The Diabetes Treatment Satisfaction Questionnaire for change from Baseline (DTSQc) to study end contains 6 items which can be rated from -3='much worse now' to 3='much better now'). The total score is the sum of the scores of the 6 items and ranges from -18 to 18. A higher score indicates more satisfaction. This questionnaire was administered at the end of the study (Week 24) only.|Week 24|The full analysis set (FAS) was defined as all participants enrolled and trained who had provided data using the ACCU-CHEK Connect system within 14 days of Scheduled Visit 4 during the investigation, and had completed the DTSQc at Week 24.|||score on a scale||95% Confidence Interval|Mean
2565230|NCT02600819|Secondary|PK Parameter: Ctau of EVG, COBI, FTC, and TFV|Ctau is defined as the observed drug concentration at the end of the dosing interval. Ctau has been presented in lieu of Cmin (specified in the protocol) to align with other Gilead studies. This change has no impact on the PK analysis as Ctau and Cmin are equivalent for all analytes.|0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2565231|NCT02600819|Secondary|PK Parameter: Cmax of EVG, COBI, FTC, TAF, and TFV|Cmax is defined as the maximum concentration of drug.|0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2565232|NCT02600819|Secondary|PK Parameter: AUClast of EVG, COBI, FTC, Tenofovir Alafenamide (TAF), and TFV|AUClast is defined as the area under the concentration versus time curve from time zero to the last observable concentration.|0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
2565233|NCT02600819|Secondary|Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG), Cobicistat (COBI), Emtricitabine (FTC), and Tenofovir (TFV)|AUCtau is defined as area under the concentration versus time curve over the dosing interval (i.e., concentration of drug over time).|0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set (participants who were enrolled into the study, participated in the intensive PK substudy, received at least 1 dose of E/C/F/TAF, and had at least 1 nonmissing plasma PK concentration value for any analyte of interest) with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
2565234|NCT02600819|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the FDA Snapshot Algorithm|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2565235|NCT02600819|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2565236|NCT02600819|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|The Full Analysis Set included participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2565237|NCT02600819|Secondary|Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 96||First Dose Date up to Week 96|Participants in the Safety Analysis Set were analyzed.|||percentage of participants|||Number
2565238|NCT02600819|Primary|Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 48||First Dose Date up to Week 48|The Safety Analysis Set included participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2565239|NCT02600767|Primary|Absence of Malaria Parasites in Blood.|Investigators will evaluate the percentage of patients who remain free of malaria parasites in the blood during the 28-day follow-up period.|28 days||||Participants|||Count of Participants
2565248|NCT02600637|Secondary|Repeatable Battery for Assessment of Neuropsychological Status Battery Overall Cognitive Change Score|Determine whether the MBSR treatment has any effect on overall cognitive performance by comparing the change score (post-intervention minus pre-intervention) in overall Cognitive standard score on RBANS for MBSR versus Education control group. Positive change score indicates improvement in overall cognitive performance. The possible range of standard scores on the RBANS is 40-154, where 40 is severely impaired cognition and 154 is superior range cognition.|Over the 8 week assessment period for each participant, up to a total of 5 months||||units on a scale||Standard Deviation|Mean
2565249|NCT02600637|Primary|Anxiety Score Change on State-Trait Anxiety Inventory Questionnaire|Determine whether the MBSR treatment has any effect on anxiety by comparing change score (post-intervention minus pre-intervention) on State-Trait Anxiety Inventory (STAI) for MBSR versus Education control group. A negative change score indicates improvement in anxiety symptoms. Full range of scores on the STAI is 20-80, where 20 is minimal/no anxiety and 80 is severe anxiety.|Over the 8 week assessment period for each participant, up to a total of 5 months||||units on a scale||Standard Deviation|Mean
2565250|NCT02600637|Primary|Depression Score Change on Geriatric Depression Scale|Determine whether the MBSR treatment has any effect on depression by comparing change scores (post-intervention minus pre-intervention) on the Geriatric Depression Scale (GDS) for MBSR versus Education control group. A negative change score indicates improvement in depressive symptomatology. Full score range possible on the GDS is 0-30, where 0 means no depression and 30 means severe depression.|Over the 8 week assessment period for each participant, up to a total of 5 months||||units on a scale||Standard Deviation|Mean
2565251|NCT02600611|Secondary|Resolution or Near Resolution of Lesion at Test of Cure Visit|Resolution or near resolution of lesion at Test of Cure (TOC) visit|7 to14 days after the end of treatment|all randomized patients (ITT population)|||participants|||Number
2565252|NCT02600611|Primary|≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline in All Randomized Patients.|≥20% reduction in lesion size at 48 to 72 hours (Early Time Point [ETP]) compared to baseline in all randomized patients (ITT).|Baseline and 48-72 hours after first dose of study drug|all randomized patients (ITT).|||percentage of participants|||Number
2565253|NCT02600403|Primary|Visual Field|Visual field pattern standard deviation in decibels (dB). Visual field results compare visual field loss to age matched controls (people with no eye diseases or visual field loss). Brightness of the flashes of light used to test peripheral vision during a visual field test is measured in decibels. With a localized defect in the visual field, pattern standard deviation (PSD) quantifies amount of loss and progression of glaucoma when in the beginning stages of the disease.|12 months||||dB||Standard Deviation|Mean
2565254|NCT02600403|Primary|Visual Evoked Potential Latency|VEP latency at high contrast as measured in milliseconds (ms). Electroencephalogram (EEG) measures electrical activity in the brain. VEP measures electrical activity in areas of the brain responsible for vision by using EEG electrodes. VEP latencies measure the duration in time of the energy generated (duration of the signal) from the eye's response to a visual stimulus during the VEP.|12 months||||Milli-seconds (ms)||Standard Deviation|Mean
2565255|NCT02600403|Primary|Visual Evoked Potential Amplitudes|VEP amplitudes at high contrast as measured in microvolts (μV). Electroencephalogram (EEG) measures electrical activity in the brain. VEP measures electrical activity in areas of the brain responsible for vision by using EEG electrodes. The amplitude measurement is the peak of the energy generated (strongest strength of the signal) from the eye's response to the visual stimulus during the VEP.|12 months||||micro volts (uV)||Standard Deviation|Mean
2565256|NCT02600403|Primary|Average Cup to Disc Ratio|Cup to disc ratio is used to evaluate structural changes comparing the size of the cup to the size of the disc during dilated ophthalmic examination. High eye pressure can cause the cup to enlarge, closer to the size of the disc. This measurement is used to follow progression in glaucoma. A normal range for cup to disc ratio would be 0.0 to 0.4. Advanced glaucoma would be 0.8 to 0.9 cup to disc ratio.|12 months||||ratio||Standard Deviation|Mean
2565257|NCT02600403|Primary|Retinal Nerve Fiber Layer (RNFL) Thickness Measurement|Retinal nerve fiber layer (RNFL) thickness in different quadrants of optic nerve and macula are measured pre and postoperatively to evaluate structural changes.|12 months||||um||Standard Deviation|Mean
2565258|NCT02600403|Primary|Visual Field Mean Deviation|Visual field mean deviation as measured in decibels (dB) is the amount of visual field loss compared to age matched controls (people with no eye diseases or visual field loss). Brightness of the flashes of light used to test peripheral vision during a visual field test is measured in decibels. Brighter light has lower number in decibels. The dimmer the light, the higher the number in decibels with a range of 0 to 40 dB.|12 months||||dB (decibels)||Standard Deviation|Mean
2565259|NCT02600351|Secondary|Number of Participants With Emerging Resistance|The full-length NS3, NS5A, and NS5B coding regions were deep sequenced at pretreatment (baseline) for all participants included in the Full Analysis Set, and at posttreatment for all participants who relapsed.|Up to Posttreatment Week 24|Full Analysis Set by Actual Treatment who have pre-existing NS5B, NS5A, and NS3/4A resistance-associated variants (RAVs) at baseline and who experienced virologic failure were analyzed. There were no participants with pre-existing RAVs who experienced virologic failure in the LDV/SOF+RBV 12 weeks, without cirrhosis group.|||Participants|||Count of Participants
2565260|NCT02600351|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA <LLOQ at last on-treatment visit.|Up to Posttreatment Week 24|Full Analysis Set by Actual Treatment|||percentage of participants|||Number
2565261|NCT02600351|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment.|Up to 24 weeks|Full Analysis Set by Actual Treatment|||percentage of participants|||Number
2565262|NCT02600351|Secondary|Percentage of Participants With HCV RNA < the Lower Limit of Quantitation (LLOQ) at 4 and 24 Weeks Posttreatment|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set by Actual Treatment|||percentage of participants||95% Confidence Interval|Number
2565263|NCT02600351|Primary|Percentage of Participants Who Discontinued From Study Treatment for an Adverse Event||Up to 24 weeks|Safety Analysis Set|||percentage of participants|||Number
2565264|NCT02600351|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Cessation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set by Actual Treatment: participants were grouped according to their cirrhotic status and the treatment/duration they actually received.|||percentage of participants||95% Confidence Interval|Number
2565265|NCT02600325|Secondary|SVR12 (Reinfection Equals Failure)|Sustained viral response (SVR) 12 weeks after the end of therapy in all patients who started treatment in which reinfections are considered failure|week 12||||Participants|||Count of Participants
2565266|NCT02600325|Primary|SVR12 (Reinfection Not Considered Failure)|Sustained viral response (SVR) 12 weeks after the end of therapy in all patients who started treatment in which reinfections are not considered failure|12 weeks||||participants|||Number
2565267|NCT02599961|Secondary|Change From Baseline Over Time in SF-12v2 Health Survey MCS Score|SF-12v2 was assessed for adults 18 years of age and older. Eight domain scores were used to generate 2 component summary scores: physical health (PCS) and mental health (MCS). The PCS and MCS scores have mean of 50 and SD of 10. The T-score based scoring method scores the data in relation to U.S. general population T-scores. Therefore, all scores obtained that are below 50 can be interpreted as below the U.S. general population T-score and scores above 50 can be interpreted as above the U.S. general population T-score. Higher global scores are associated with better quality of life.|Baseline (from NCT01993186), Month 0, Month 6, Month 12, Month 18|Adult participants with a baseline and postbaseline assessment at given time point.|||T-score||Standard Deviation|Mean
2565268|NCT02599961|Secondary|Change From Baseline Over Time in SF-12v2 Health Survey PCS Score|SF-12v2 was assessed for adults 18 years of age and older. Eight domain scores were used to generate 2 component summary scores: physical health (PCS) and mental health (MCS). The PCS and MCS scores have mean of 50 and SD of 10. The T-score based scoring method scores the data in relation to U.S. general population T-scores. Therefore, all scores obtained that are below 50 can be interpreted as below the U.S. general population T-score and scores above 50 can be interpreted as above the U.S. general population T-score. Higher global scores are associated with better quality of life.|Baseline (from NCT01993186), Month 0, Month 6, Month 12, Month 18|Adult participants with a baseline and postbaseline assessment at given time point.|||T-score||Standard Deviation|Mean
2565269|NCT02599961|Secondary|Change From Baseline Over Time in SF-10 Health Survey for Children Psychosocial Summary Score|The SF-10 Health Survey for Children was administered to caregivers of participants aged 5-17 years. Responses are used to generate 2 component summary scores: Physical Summary Score and the Psychosocial Summary Score. The T-score based scale scores were centered so that a score of 50 corresponds to the average score in a comprehensive 2006 sample (a combination of general population and supplemental disability and chronic condition samples). Higher scores are associated with better quality of life.|Baseline (from NCT01993186), Month 0, Month 6, Month 12, Month 18, Month 24, Month 30|Pediatric participants with a baseline and postbaseline assessment at given time point.|||T-score||Standard Deviation|Mean
2565270|NCT02599961|Secondary|Change From Baseline Over Time in SF-10 Health Survey for Children Physical Summary Score|The SF-10 Health Survey for Children was administered to caregivers of participants aged 5-17 years. Responses are used to generate 2 component summary scores: Physical Summary Score and the Psychosocial Summary Score. The T-score based scale scores were centered so that a score of 50 corresponds to the average score in a comprehensive 2006 sample (a combination of general population and supplemental disability and chronic condition samples). Higher scores are associated with better quality of life.|Baseline (from NCT01993186), Month 0, Month 6, Month 12, Month 18, Month 24, Month 30|Pediatric participants with a baseline and postbaseline assessment at given time point.|||T-score||Standard Deviation|Mean
2565271|NCT02599961|Secondary|Change From Baseline Over Time in CNS Total Score|The CNS evaluates measures of neurological function and development delay, and is the sum of scores for the following domains: Weight, Height, Head Circumference, General Medical Exam, Funduscopic Exam, Cranial Nerves, Stance & Gait, Involuntary Movements, Sensation, Cerebellar Function, Muscle Bulk, Tone & Strength, Myotatic Reflexes, Toe Sign, Other Findings. The CNS is only scored when all domains are measured and ranges from 0 (abnormal exam) to 76 (normal exam). Higher scores are associated with higher neurological function.|Baseline (from NCT01993186), Month 0, Month 6, Month 12, Month 24, Month 36|Participants with a baseline and postbaseline assessment at given time point.|||score on a scale||Standard Deviation|Mean
2565272|NCT02599961|Secondary|Change From Baseline Over Time in Overall Seizure Frequency Per 4 Weeks|The number of observable seizures were recorded by the subject or caregiver via diary throughout the study. Observable seizures were defined as: generalized tonic-clonic; generalized tonic; generalized clonic; generalized atonic; partial/focal with secondary generalization; myoclonic, myoclonic (astatic) atonic, myoclonic tonic; complex partial/focal; simple partial/focal motor; absence.|Baseline (from NCT01993186), Month 0-3, Month 4-6, Month 7-9, Month 10-12, Month 13-18, Month 19-24, Month 25-30, Month 31-36|Participants with a baseline and postbaseline assessment at given time point.|||seizures per 4 weeks||Standard Deviation|Mean
2565273|NCT02599961|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Discontinuations Due to TEAEs, and Deaths|An adverse event (AE) was defined as any untoward medical occurrence, whether or not considered drug related. Serious adverse events (SAEs) are AEs that at any dose, in the view of either the investigator or sponsor, results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or disability; a congenital anomaly/birth defect; other important medical event. An AE was considered a TEAE if it occurred on or after the first dose in this study, and was not present prior to the first dose in this study, or it was present at the first dose in this study but increased in severity during the study. Severity was based on Common Terminology Criteria for Adverse Events (CTCAE): 1 = mild, 2 = moderate, 3 = severe, 4 = life threatening, and 5 = death related to AE.|From first dose of study drug up to 36 months. The mean (SD) treatment duration was 667.9 (357) days.||||Participants|||Count of Participants
2565274|NCT02599766|Secondary|Motor Activity|Assessed via actimeter at the patients wrist during sessions, measuring acceleration of the hand. It records data in 15-s epochs for maximum sensitivity. Data were calculated to yield average activity Counts per minute.|6 weeks||||counts per minute||Standard Deviation|Mean
2565275|NCT02599766|Secondary|Heart Rate|Assessed via EKG (Polar) during the sessions and measured in beat/min.|6 weeks||||beats per minute||Standard Deviation|Mean
2565284|NCT02599766|Secondary|Social Functioning: Physical Contact|Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of the defined physical contact is collected and aggregated to one measure.|6 weeks||||percentage of physical contact||Standard Deviation|Mean
2565285|NCT02599766|Secondary|Social Functioning: Nonverbal Communication|Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of the defined nonverbal behaviors is collected and aggregated to one measure.|6 weeks||||percentage of nonverbal communication||Standard Deviation|Mean
2565286|NCT02599766|Secondary|Social Functioning: Verbal Communication|Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentages of the defined verbal behaviors is collected and aggregated to one measure.|6 weeks||||percentage of verbal communication||Standard Deviation|Mean
2565287|NCT02599766|Primary|Social Functioning: Total Social Behavior|Interaction and communication behavior is assessed via video coding in Noldus Observer. Percentage of all social behaviors are collected and aggregated to one measure, the total social behavior.|6 weeks||||percentage of shown behavior||Standard Deviation|Mean
2565288|NCT02599649|Primary|Overall Response Rate (ORR)|Overall response rate (ORR) defined as complete response plus partial response (CR + PR) and hematological improvement (HI). MDS International Working Group criteria used to assess response.|116 days|Initially, a sample size of 20 patients for each cohort was planned, but the enrollment was stopped after the sponsor's decision not to pursue the development of lirilumab for myeloid malignancies. The study did not enroll long enough to reach the arms that combined Nivolumab + Lirilumab +/- Azacitidine.|||Participants|||Count of Participants
2565289|NCT02599441|Secondary|Medial Clear Space on Standard Xray||Baseline||||mm||Standard Deviation|Mean
2565290|NCT02599441|Secondary|Medial Clear Space on Gravity Stress Xray||Baseline||||mm||Standard Deviation|Mean
2565291|NCT02599441|Primary|Medial Clear Space Distance in the Ankle Joint|measured on weight bearing CBCT|Baseline- single-day study||||mm||Standard Deviation|Mean
2565292|NCT02599194|Secondary|Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs|Lesion size in centimeters (cm) were assessed in 2 dimensions from the computed tomography (CT) component of PET/CT and the area in cm2 calculated for lesion locations at baseline and after treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported the difference in area in cm² for each lesion (a number without dispersion).|Baseline and up to 2 years|"Lesion locations not detected both before and after treatment are reported as N/A for 2-D area (in the effect that an assessment could be made with the other radiolabel).~Lesions detected at either before or after treatment only are reported as the difference from zero."|||cm2|Lesion locations assessed||Number
2565293|NCT02599194|Secondary|Number of Treatment-Related Adverse Events|Safety and tolerability of 18F-FSPG and 18F-FDG were assessed as treatment-related adverse events, and reported as the number of events related to each treatment, without dispersion.|Baseline to up to 2 years||||adverse events|||Number
2565294|NCT02599194|Primary|Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment|Standard Uptake Values (SUVs) for the radiotracers labels 18F-FSPG and 18F-FDG were assessed in tumor tissues of study participants, before (baseline), and after therapeutic treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported as the difference of means from baseline to post-treatment (a number without dispersion), for all lesions for which an SUVmax value was assessed. A negative result indicates less uptake of radiotracer suggesting a small volume of tumor.|Baseline and up to 2 years|"Locations (ie, of lesions) that did not produce an SUVmax value either before or after treatment are omitted from the mean. Note that an analysis mean of differences would have a dispersion, but an analysis for difference of means is simply the delta (a number) between 2 measures of central tendency (mean), and does not have a dispersion."|||g/mL|Lesion locations assessed||Number
2565295|NCT02599129|Secondary|Number of Subjects With Dermatology Life Quality Index (DLQI) of 3 or Above|Number of subjects achieving a DLQI (Dermatology Life Quality Index), patient global assessment score of 3 or above at week 24 (0, no regrowth; 1, <25% of regrowth; 2, 25%-49% of regrowth; 3, 50%-74% of regrowth; 4, 75%-99% of re- growth; 5, 100% of regrowth).|Week 24||||Participants|||Count of Participants
2565296|NCT02599129|Secondary|Number of Subjects Acheiving Physician's Global Assessment (PGA) Score of 3 or Above|Number of subjects achieving a Physician's Global Assessment (PGA) score of 3 or above at week 24 (0, no regrowth; 1, <25% of regrowth; 2, 25%-49% of regrowth; 3, 50%-74% of regrowth; 4, 75%-99% of re- growth; 5, 100% of regrowth).|Week 24||||Participants|||Count of Participants
2565297|NCT02599129|Secondary|Number of Subjects Achieving a SALT Score of 90 at Week 28|Number of subjects achieving a SALT score of 90|week 28||||Participants|||Count of Participants
2565298|NCT02599129|Secondary|Number of Subjects Achieving a SALT Score of 90 at Week 24|Number of subjects achieving a SALT score of 90 at week 24|week 24||||Participants|||Count of Participants
2565299|NCT02599129|Primary|Number of Subjects Achieving Severity of Alopecia Tool (SALT) Score of 50|Number of subjects achieving a Severity of Alopecia Tool (SALT) score of 50 at Week 24|Week 24||||Participants|||Count of Participants
2565300|NCT02598934|Secondary|"Percentage of Participants Who Were Very Confident or Confident to Items on the Boniva Confidence Scale (BCS) at Month 6"|The BCS is designed to measure the participant's confidence level that Boniva (ibandronate) therapy is effective in treating osteoporosis and reducing the risk of fracture. Response options ranged on a 5-point scale from 'Not At All Confident' to 'Very Confident.' A Boniva confidence responder was defined as a participant who reported a response of 'confident' or 'very confident' on the 2 items in BCS. (1) ibandronate was effective in treating osteoporosis and (2) ibandronate reduces the risk of breaking a bone.|Month 6|ITT population|||percentage of participants|||Number
2565370|NCT02597920|Primary|Patient Characterization at Baseline - Creatinine Clearance|Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.|Baseline|Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.|||millilitre/ minute [mL/min]||Standard Deviation|Mean
2565301|NCT02598934|Secondary|Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP)|Serum BSAP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.|||percent change||Standard Deviation|Mean
2565302|NCT02598934|Secondary|Percent Change From Baseline to Month 6 in Serum Osteocalcin|Serum osteocalcin is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.|||percent change||Standard Deviation|Mean
2565303|NCT02598934|Secondary|Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)|Serum P1NP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus Baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.|||percent change||Standard Deviation|Mean
2565304|NCT02598934|Secondary|Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX)|Urine NTX is a measure of bone resorption and is measured as millimoles bone collagen equivalents per millimoles creatinine. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.|||percent change||Standard Deviation|Mean
2565305|NCT02598934|Primary|Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX)|Serum CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).|Baseline, Month 6|ITT population observed cases: all participants of ITT population with available data for this outcome measure.|||percent change||Standard Deviation|Mean
2565306|NCT02598622|Primary|Grade of Neurotoxicity Will be Captured by an Adaptation of the Total Peripheral Neuropathy Score.||Days 1 - 21|Only 2 out of 8 participants were able to complete protocol related therapy and therefore no data were collected for analysis.||||||
2565307|NCT02598583|Secondary|Change In Clinical Manifestations Of PNH From Baseline To Day 169|Clinical manifestations are defined as fatigue, abdominal pain, dyspnea, dysphagia, chest pain, and erectile dysfunction (ED) by cohort. Improvement is defined as present at baseline and absent at Day 169 endpoint. Worsening is defined as absent at Baseline and present at Day 169 endpoint.|Baseline, Day 169|The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 clinical manifestation of PNH assessed post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point. ED affects only male participants.|||Participants|||Count of Participants
2565308|NCT02598583|Secondary|Percent Change In D-dimer Levels From Baseline To Day 169|Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion.|Baseline, Day 169|The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 D-dimer measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point.|||Percent change||Standard Deviation|Mean
2565309|NCT02598583|Secondary|Percent Change In Paroxysmal Nocturnal Hemoglobinuria (PNH) Red Blood Cell (RBC) Clones From Baseline To Day 169|Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion.|Baseline, Day 169|The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 PNH RBC clones measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point.|||Percent change||Standard Deviation|Mean
2565310|NCT02598583|Secondary|Percent Change In Reticulocyte/Erythrocyte Count From Baseline To Day 169|Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion.|Baseline, Day 169|The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 reticulocyte/erythrocyte count measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point.|||Percent change||Standard Deviation|Mean
2565311|NCT02598583|Secondary|Percent Change In Haptoglobin Levels From Baseline To Day 169|Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion.|Baseline, Day 169|The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 haptoglobin measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point.|||Percent change||Standard Deviation|Mean
2565312|NCT02598583|Secondary|Percent Change In Free Hemoglobin Levels From Baseline To Day 169|Baseline was defined as the last non-missing assessment value prior to the first ALXN1210 infusion.|Baseline, Day 169|The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 free hemoglobin measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point.|||Percent change||Standard Deviation|Mean
2565385|NCT02597543|Secondary|Late Gadolinium Enhancement|Late gadolinium enhancement demonstrates myocardial scar by cardiac MRI. This is measured the day of the cardiac MRI scan and is a one time measurement. Time frame is measurement of late gadolinium enhancement from date of heart-transplantation.|Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation.||||percentage of myocardium||Standard Deviation|Mean
2565313|NCT02598583|Primary|Percent Change In Lactate Dehydrogenase (LDH) Levels From Baseline To Day 169|Baseline was defined as the average of all available assessments prior to first ALXN1210 infusion.|Baseline, Day 169|The full analysis set included all enrolled participants who received at least 1 dose of ALXN1210 and who had a Baseline measurement with at least 1 LDH measurement post-first ALXN1210 dose. Data were summarized only for participants with assessment at Baseline and the specified time point.|||Percent change||Standard Deviation|Mean
2565314|NCT02598297|Secondary|Time to First Symptomatic Progression (TTSP)|Time to first symptomatic progression as determined by Myelofibrosis 7 Item Symptom Scale (MF-7)|From randomization until symptomatic progression (MF-7)(estimated to be assessed up to 48 months)|The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that any time to event endpoint would not be derived.||||||
2565315|NCT02598297|Secondary|Time to First Progressive Splenomegaly (TTPS)|Time to first progressive splenomegaly as determined by spleen volume (by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT).|From randomization until earliest time to progressive splenomegaly (estimated to be assessed up to 48 months)|The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that any time to event endpoint would not be derived.||||||
2565316|NCT02598297|Secondary|Quality-adjusted Life Years From Baseline|EQ-5D-5L (EuroQol-5D-5L, is a standardized instrument for measuring health outcomes, is consists of a descriptive system and a visual analogue scale - scores can be summarized into a single index score that provides a simple measure of health for clinical and economic appraisal ) The EQ-5D-5L health states will be converted into index values (utilities) from which the QALY (Quality - adjusted life years) will be calculated. QALY will be summarized descriptively by treatment arm.|Change from Baseline compared with scheduled study visits at the following intervals every 4 weeks up to week 24, every 8 weeks up to Week 48, every 12 weeks past Wk 48 until End of treatment and 30 day follow up visit|The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that any time to event endpoint would not be derived.||||||
2565317|NCT02598297|Secondary|Progression Free Survival (PFS-2)|PFS-2 assessed by 25% increase over new baseline of PFS-1 in any of the following: ● Progressive splenomegaly ● 25 % increase in MF-7 score with absolute score ≥ 30|From date of randomization until second disease progression or death, whichever comes first (estimated to be assessed up to 72 months)|The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that any time to event endpoint would not be derived||||||
2565318|NCT02598297|Secondary|Plasma Ruxolitinib Concentrations|Characterize pharmacokinetics (PK)by utilizing a population PK approach.|Week 12, Wk 48|The Pharmacokinetics (PK) Analysis Set (PAS) consisted of all patients set who have received at least one dose of ruxolitinib and provided evaluable PK data. The PK analysis was never done as the study terminated early.||||||
2565319|NCT02598297|Secondary|Overall Survival|To evaluate the effect of ruxolitinib on overall survival|Time from randomization to date of death due to any cause (estimated to be assessed up to 48 months).|The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that any time to event endpoint would not be derived.||||||
2565320|NCT02598297|Secondary|Number of Participants With Specific Subscale Scores (From Baseline) Using EQ-5D|"EQ-ED5 profiles were summarized at baseline and at each scheduled assessment for each of the 5 dimensions separately (Mobility, self-care, usual activities, pain discomfort, anxiety/depression) Only participants with baseline score and at least one non-missing post-baseline score during the treatment period were included. Percentages were based on all these evaluable participants.~The 5 scores for mobility, self-care, usual activities, pain/discomfort and anxiety/depression are all self-explanatory (eg I have no problems walking to I am unable to walk), except for the following overall health check, where 100 is the best of health, and 0 is the worst health."|From Baseline and assessed every 4 weeks until end of treatment|The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. Only the categories with non-zero counts are presented with these results. Only subjects with baseline score and at least one non-missing post-baseline score during the treatment period 1 were included. % is based on all these evaluable subjects.|||Participants|||Count of Participants
2565321|NCT02598297|Secondary|Percentage Change in Symptoms From Baseline Using MF-7|Percentage change from Baseline in MF-7 total symptom score and 7 individual symptoms at each visit was summarized with descriptive statistics. For this scale, symptoms range from 0 to 10 for the severity experienced within the past 24 hours, with 0 being for absence of symptoms and 10 for worst imaginable symptoms.|From Baseline and assessed every 4 weeks until end of treatment|The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.|||Percentage change in scores||Standard Deviation|Mean
2565322|NCT02598297|Secondary|Percentage Change in Spleen Volume From Baseline|Change in spleen volume (by MRI/CT) from baseline|From baseline and assessed on 12 week intervals until end of treatment (EOT)|The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment.|||Percentage change from baseline||Standard Deviation|Mean
2565323|NCT02598297|Secondary|Time to Primary Progression (TTP)|TTP is defined as time from randomization until disease progression as defined for PFS-1 excluding death as an event.|From randomization till progression (estimated to be assessed up to 48 months)|The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that any time to event endpoint would not be derived.||||||
2565386|NCT02597543|Secondary|Re-transplantation|Re-transplantation of the heart after enrollment (date of cardiac MRI). Measured 10 months after enrollment.|10 months after enrollment (from date of cardiac MRI)||||Participants|||Count of Participants
2565387|NCT02597543|Secondary|Hospitalization for Cardiac Related Causes|Hospitalization for cardiac related causes after enrollment. Time frame after enrollment (date of cardiac MRI) was 10 months|10 months after enrollment (from date of cardiac MRI)||||Participants|||Count of Participants
2565324|NCT02598297|Primary|Progression Free Survival (PFS-1)|"Progression free survival (PFS-1) from date of randomization until the occurrence of any of the criteria for disease progression:~Progressive splenomegaly~Circulating peripheral blast counts > 10%~Leukemic transformation~Hb < 10g/dl with absolute decrease of at least 3 g/dl from baseline~White blood cell (WBC) counts > 25 x 103/ μL~MF-7 score ≥ 30~Death from any cause"|From randomization till disease progression (estimated to be assessed up 48 months)|The Full Analysis Set (FAS) included all subjects who were randomized to a study treatment. This endpoint was not analyzed as study was terminated and it was specified in the statistical analysis plan (SAP) that the primary endpoint of PFS and any other time to event endpoint would not be derived.||||||
2565325|NCT02598193|Secondary|Total Number of Days From the Initiation of Combination Treatment to Discontinuation of Pirfenidone, Nintedanib, or Both Study Treatments||Baseline up to Week 24|Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1.|||Number of Days||Standard Deviation|Mean
2565326|NCT02598193|Secondary|Total Number of Participant Days of Combination Treatment With Pirfenidone and Nintedanib||Baseline up to Week 24|Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1.|||Participant Days|||Number
2565327|NCT02598193|Secondary|Percentage of Participants Who Discontinue Pirfenidone, Nintedanib, or Both Study Treatments Because of Adverse Events Before the Week 24 Visit||Baseline up to Week 24|Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1.|||Percentage of Praticipants||95% Confidence Interval|Number
2565328|NCT02598193|Secondary|Percentage of Participants With Adverse Events and Serious Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline up to Week 28|Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1.|||Percentage of Participants|||Number
2565329|NCT02598193|Primary|Percentage of Participants Who Complete 24 Weeks of Combination Treatment on Pirfenidone at a Dose of 1602-2403 mg/Day and Nintedanib at a Dose of 200-300 mg/Day||Week 24|Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1.|||Percentage of Participants||95% Confidence Interval|Number
2565330|NCT02598128|Other Pre-specified|Ease of Use of RELiZORB (Per-Protocol Population)|Effect of enteral nutrition on select activities of daily living. Patients judged the size of breakfast after overnight enteral tube feeding with the following choices: No breakfast; Small breakfast; Normal breakfast; Big breakfast; Other.|Period C: Single assessment on Day 19 or 20|Per Protocol Population.|||Participants|||Count of Participants
2565331|NCT02598128|Primary|Long Chain Polyunsaturated Fatty Acid Plasma Concentration (Intent to Treat Population)|AUC analysis of plasma fatty acid concentration for DHA + EPA baseline adjusted over 24-hours|Day 1 first intervention and Day 9 second intervention.||||ug*h/mL||Standard Deviation|Mean
2565332|NCT02598128|Primary|Number of Patients With Adverse Events and Unanticipated Adverse Device Effects|1) Frequency and severity of adverse events; 2) Patients with at least one unanticipated adverse device effects (UADE)|27 days|Safety Population|||Participants|||Count of Participants
2565333|NCT02598089|Secondary|Geometric Fold Rises (GMFRs) of Neutralizing Antibodies (MNT) Post-vaccination/Pre-vaccination for Each of the 3 Antigens||Pre- (Day 1) and Post-vaccination (Day 22)|All vaccinated subjects who have valid post-vaccination immunogenicity measures with no major protocol violations|||fold rise||95% Confidence Interval|Geometric Mean
2565334|NCT02598089|Secondary|Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 1) and Post-Vaccination (Day 22) for Each of the 3 Antigens||Pre- (Day 1) and Post-vaccination (Day 22)|All vaccinated subjects who have valid post vaccination immunogenicity measures with no major protocol deviations|||Titers||95% Confidence Interval|Geometric Mean
2565335|NCT02598089|Secondary|Geometric Mean Fold Rises (GMFRs) of Serum Hemaggluntination Inhibition (HAI) Antibodies|Geometric mean fold rises (GMFRs) of serum hemaggluntination inhibition (HAI) antibodies post-vaccination/pre-vaccination for each of the 3 antigens|Day 22/Day1||||fold rise||95% Confidence Interval|Geometric Mean
2565336|NCT02598089|Secondary|Geometric Mean Titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) Antibodies for Each Antigen|Geometric mean titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) antibodies pre- (Day 1) and post-vaccination (Day 22) for each of the 3 antigens.|Pre- (Day 1) and post-vaccination (Day 22)||||Titers||95% Confidence Interval|Geometric Mean
2565337|NCT02598089|Secondary|Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine|A seroprotected subject was defined as a vaccinated subject who had a serum Hemagluttination Inhibition (HAI) titer >/= 1:40. The 3 influenza strains assessed were B, H1, and H3.|Day 1 and Day 22 post vaccination||||Participants|||Count of Participants
2565338|NCT02598089|Secondary|Number and Percentage of Subjects With Seroconversion Against Each of the 3 Antigens|"Seroconversion is defined as a serum HAI titer meeting the following criteria:~pre-vaccination titer <1:10 and a post-vaccination titer ≥ 1:40 or~pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination measured on Day 22."|Day 22||||Participants|||Count of Participants
2565339|NCT02598089|Primary|Number and Percentage of Participants With Serious Adverse Events (SAEs)||Over the entire study period (Day 91)|The analysis was conducted for subjects who were randomized and received a study vaccination|||Participants|||Count of Participants
2565388|NCT02597543|Secondary|Myocardial Ischemia/Infarction|Myocardial ischemia or infarct occurring from time of enrollment (when cardiac MRI performed) over subsequent 10 month period.|10 months after enrollment (when cardiac MRI was performed)||||Participants|||Count of Participants
2565692|NCT02590588|Secondary|Quality of Life|Evaluate quality of life according to Functional Assessment of Cancer Therapy Lymphoma Subscale (FACT-Lym) assessment tool|3 months|'There was only one patient enrolled and he did not remain on study long enough for his first protocol-specified quality of life assessment||||||
2565340|NCT02598089|Primary|Number and Percentage of Participants With Unsolicited Adverse Events|"Unsolicited AEs were any AEs that occurred any time after the vaccine/placebo was administered (temporally related to investigational product), whether or not deemed related to the product, and are not solicited (specifically asked of the subject). Unsolicited AEs were to be observed by the study center personnel while the subject was at the study center for a study visit or reported by the subject at any time. Any sign or symptom that would normally be considered a solicited AE (for example, fever, nausea, injection site pain) starting after 7 days post-vaccination were to be recorded as an unsolicited AE. In this study, laboratory results were considered AEs when (1) the result was judged to be clinically significant by the Principal Investigator, regardless of grade; or (2) the result is Grade 2 or higher.~Note: all unsolicited AEs were mild in intensity. Please see Adverse Events section of this report for detailed information of AEs."|Within 21 days post-vaccination|The analysis was conducted for subjects who were randomized and received a study vaccination.|||Participants|||Count of Participants
2565341|NCT02598089|Primary|Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity|Number of subjects reporting solicted systemic reactions (fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache) post-vaccination with study vaccine or placebo|7-day period (Days 1-7) post-vaccination|The analysis was conducted for subjects who were randomized and received a study vaccination|||Participants|||Count of Participants
2565342|NCT02598089|Primary|Number and Percentage of Participants Reporting Solicited Local Reactogenicity|Number of subjects reporting solicited local reactions (redness, swelling, pain, hardness, and tenderness) at the injection site post-vaccination with study vaccine or placebo.|7-day period (Days 1-7) post-vaccination.|The analysis was conducted for subjects who were randomized and received a study vaccination|||Participants|||Count of Participants
2565343|NCT02598089|Primary|Number of Participants With Immediate Adverse Events|Any adverse event occurring within the 30 minute post vaccination period.|30-minute post-vaccination period.|The analysis was conducted for subjects who were randomized and received a study vaccination.|||participants||95% Confidence Interval|Number
2565344|NCT02598076|Secondary|Change in Quality of Life|Change from baseline to 4 month follow-up, in quality of life in epilepsy (QOLIE)-10 score. Quality of Life in Epilepsy (QOLIE)-10 scale is a validated, reliable instrument measuring quality of life on a scale from 10 (best) to 50 (worst). Total score was used. No sub-scales were used.|4 months|Participants who provided QOLIE-10 information at 4-month follow-up|||units on QOLIE-10 scale||Standard Deviation|Mean
2565345|NCT02598076|Secondary|PNES Freedom|Patients are classified as PNES free if they have had no PNES in 3 months, otherwise they are classified as not PNES free.|4 months|Participants who provided information at 4 month telephone follow-up|||Participants|||Count of Participants
2565346|NCT02598076|Secondary|Change in Number of Monthly Emergency Department Visits|Change from baseline number of Emergency Department visits per month.|4 months|Participants who provided this data at 4 month telephone follow-up.|||ED visits per month||Standard Deviation|Mean
2565347|NCT02598076|Secondary|Percent Decrease in PNES Frequency|Percent decrease in monthly PNES frequency|4 months|Analysis population includes all participants for whom follow-up data was available. Patients who were lost to contact (after 7 phone calls and a mailed letter) for whom follow-up data was not available, were excluded from analysis.|||percentage of baseline seizures||Standard Deviation|Mean
2565348|NCT02598076|Primary|Adherence|Patients are classified as adherent if they attend 8 or more of the recommended 12 weekly psychotherapy sessions over a 16 week period. Otherwise they are classified as non-adherent.|4 months|Analysis population includes all participants for whom follow-up data was available. Patients who were lost to contact (after 7 phone calls and a mailed letter) for whom follow-up data was not available, were excluded from analysis.|||Participants|||Count of Participants
2565349|NCT02597946|Secondary|Duration of Response (DOR) in Part A|"Duration of response (DoR) defined as the time from the first documented response PR or CR to the date of tumor progression evaluated according to RECIST 1.1 or death in part A.~Partial Response (PR): At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Complete Response (CR): Disappearance of all target lesions.~No patient had objective response and DoR was not analysed."|CT Scan at Weeks 8 & 12(for week 12 tumor assessment, time window is +1week), then every 8 weeks thereafter, after week 52, assessments will be performed every 12 weeks until progression or start of further treatment, ie up to approximately 12 Months|No patient had objective response and DoR was not analysed.||||||
2565350|NCT02597946|Secondary|Time to Progression (TTP) in Part A|"Time to progression (TTP) defined as the time from the date of starting treatment of afatinib to the date of disease progression per RECIST 1.1 in part A.~Median and 95% CI are calculated from an unadjusted Kaplan−Meier curve."|From the date of starting treatment of afatinib to the date of disease progression , ie up to approximately 12 Months|Treated Set|||Months||95% Confidence Interval|Median
2565351|NCT02597946|Secondary|Overall Survival (OS)|"Overall survival (OS) defined as the time from start of treatment of afatinib until death from any cause.~Median and 95% CI are calculated from an unadjusted Kaplan−Meier curve."|From start of treatment of afatinib until death from any cause, ie up to approximately 12 Months|Treated Set|||Months||95% Confidence Interval|Median
2565352|NCT02597946|Secondary|Progression Free Survival (PFS) in Part A|"Progression Free Survival (PFS) defined as the time from the date of starting treatment of afatinib to the date of disease progression per RECIST 1.1, or to the date of death no matter which happens first in part A.~Median and 95% confidence interval (CI) are calculated from an unadjusted Kaplan−Meier curve."|From the date of starting treatment of afatinib to the date of disease progression or to the date of death, ie up to approximately 12 Months|Treated set|||Months||95% Confidence Interval|Median
2565389|NCT02597543|Primary|Myocardial Perfusion Reserve|Myocardial perfusion reserve calculates the increase in myocardial perfusion after stress in comparison to rest. Outcome measure time frame specifies when the myocardial perfusion reserve was obtained in relation to date of heart-transplant for each patient. This was a one time measurement made after heart-transplantation.|Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation.||||arbitrary units||Standard Deviation|Mean
2565797|NCT02589171|Primary|Technical Effectiveness as Assessed by Number of Participants With Presence of Port Site Hernia Post-operatively|Abdominal ultrasound will be used to detect port site hernia.|6 weeks|Data were not available for 1 in the Carter Thomason arm.|||Participants|||Count of Participants
2565353|NCT02597946|Secondary|Percentage of Patients With Disease Control (DC) in Part A|"Percentage of patients with disease control (DC) in part A. Disease control defined as patients who have achieved confirmed complete response, partial response and stable disease as measured by CT scan or MRI according to RECIST 1.1 in part A.~Tumour Response is based on clinical, radiological or other assessment. Clopper−Pearson method used for confidence limits.~Partial Response (PR): At least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Complete Response (CR): Disappearance of all target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR, taking as reference the baseline sum LD, nor sufficient increase to qualify for Progression (PD) taking as reference the smallest sum LD since the treatment started."|CT Scan at Weeks 8 & 12(for week 12 tumor assessment, time window is +1week), then every 8 weeks thereafter, after week 52, assessments will be performed every 12 weeks until progression or start of further treatment, ie up to approximately 12 Months|Treated set|||Percentage of participants||95% Confidence Interval|Number
2565354|NCT02597946|Primary|Percentage of Patients With Objective Response (OR) in Part A According to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1|"Percentage of patients with objective response (OR) in part A according to RECIST 1.1. Objective Response defined as patients with tumour size reduction of a predefined amount using RECIST 1.1 in part A. Objective response included both confirmed Partial Response (PR) plus Complete Response (CR) as measured by Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) according to RECIST 1.1.~Partial Response (PR): At least a 30% decrease in the sum of longest diameter (LD) of target lesions asking as reference the baseline sum LD. Complete Response (CR): Disappearance of all target lesions."|CT Scan at Weeks 8 & 12 (for week 12 tumor assessment, time window is +1week), then every 8 weeks thereafter, after week 52, assessments will be performed every 12 weeks until progression or start of further treatment , ie., up to approximately 12 Months|Treated Set|||Percentage of participants|||Number
2565355|NCT02597933|Secondary|Absolute Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Dyspnoea Score at Week 52|"Absolute change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) dyspnoea score at Week 52.~FACIT-Dyspnoea (Dyspnoea) 10 Item Short Form include a 4-point rating scale (no shortness of breath=0; mildly short of breath=1; moderately short of breath = 2; severely short of breath =3; or I did not do this in the past 7 days =4).~A raw score is calculated as: Sum individual item scores * 10 / number of items answered. Raw scores are then converted to scale scores using the table included in the FACIT Dyspnoea Scale Short Form Scoring Guideline. FACIT dyspnea scale score ranges between 0 and 75.9.~The FACIT-Dyspnea short forms are scored such that a high score represents high levels of dyspnea.~Least square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and up to 52 weeks after the start of administration|Treated set|||Unit on a scale||Standard Error|Least Squares Mean
2565356|NCT02597933|Secondary|Absolute Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52|"Absolute change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) score at Week 52.~The HAQ-DI score is calculated as follows:~Each question is scored 0-3 (where 0= without difficulty & 3= unable to do). There are 8 categories (Dressing & Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, Activities), each including 2 or 3 questions. The score for each category corresponds to maximum question score within each category.~Finally, HAQ-DI score corresponds to sum of the sub-scores of all 8 categories divided by number of categories completed. Please note that if there are fewer than 6 categories with responses, then a score cannot be calculated.~The HAQ-DI score scale has 25 possible values (i.e., 0, 0.125, 0.250, 0.375 … 3). A high score corresponds to worse impairment.~Least square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and up to 52 weeks after the start of administration|Treated set|||unit on a scale||Standard Error|Least Squares Mean
2565357|NCT02597933|Secondary|Absolute Change From Baseline in Digital Ulcer Net Burden at Week 52|"Absolute change from baseline in digital ulcer net burden (defined as the number of new digital ulcers (DUs) plus the number of DUs that have been verified at any earlier assessment during the trial) at Week 52.~It is calculated at a visit by counting the total number of fingertips with ulcers (i.e. number of fingers with presence of digital ulcer ticked Yes) at the corresponding visit~Least square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and up to 52 weeks after the start of administration|Treated set|||fingers||Standard Error|Least Squares Mean
2565358|NCT02597933|Secondary|Absolute Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco) in % Predicted at Week 52|"Absolute change from baseline in Carbon Monoxide Diffusion Capacity (DLco) in % predicted at Week 52.~Least square mean is actually the adjusted mean. Adjusted mean is based on all analysed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and up to 52 weeks after the start of administration|Treated set|||% predicted DLco||Standard Error|Least Squares Mean
2565359|NCT02597933|Secondary|The Percentage (%) of Responder Based on Combined Response Index in Systemic Sclerosis (CRISS) at Week 52|"The percentage (%) of responder based on Combined Response Index in Systemic Sclerosis (CRISS) at Week 52.~This is a composite endpoint, based on the mRSS, FVC percent predicted, HAQ-DI, patient's global impression of overall health Visual Analogue Scale (VAS) and physician's global impression of patient's overall health VAS, as well as the absence of significant worsening of interstitial lung disease, a new scleroderma renal crisis, left ventricular failure or pulmonary arterial hypertension.~The CRISS index score represents a probability of improvement and ranges between 0 and 1.~This is a 2 stage process to predict probability of improvement:~Step 1 - absence of major organ progression (SRC etc.) - score 0 Step 2 - predicted probability of improvement - (score 0 - 1)"|Week 52|Treated set|||(%) of responder based on CRISS|||Number
2565360|NCT02597933|Secondary|Time to Death|Time to event analysis of patients with death. The number of observed patients with death are reported.|From date of first trial drug intake up to date of death or last contact date (ie., up to 100 weeks)|Treated set|||Participants|||Count of Participants
2565406|NCT02597127|Primary|Percentage Change in LDL-C From Baseline to Day 180|Percent Change in LDL-C (beta-quantification) from Baseline to Day 180 in MITT Population|Baseline to 180 days|Modified intent-to-treat (MITT) population|||Percent change||95% Confidence Interval|Least Squares Mean
2565407|NCT02597062|Secondary|Overall Survival|Median time to death in months will be reported|3 years|All treated patients|||months||95% Confidence Interval|Median
2565361|NCT02597933|Secondary|Relative Change From Baseline [%] of mRSS at Week 52|"Relative change from baseline [%] of mRSS at Week 52.~The modified Rodnan Skin Score (mRSS) is an evaluation of the patient's skin thickness rated by clinical palpation using a 0 to 3 scale. The scale differentiates between 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness with inability to pinch the skin into a fold.~The palpation is done for each of the 17 surface anatomic areas of the body: face, anterior chest, abdomen, fingers (right and left separately), forearms, upper arms, thighs, lower legs, dorsum of hands and feet. The sum of these individual values is defined as the total skin score. The mRSS has a range from 0 (no thickening) to 51 (severe thickening in all 17 areas). A high score corresponds to worse skin thickness.~Least square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52)."|Baseline and up to 52 weeks after the start of administration|Treated set|||percent change||Standard Error|Least Squares Mean
2565362|NCT02597933|Secondary|Absolute Change From Baseline in FVC in mL at Week 52|Absolute change from baseline in FVC in mL at Week 52. Least square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52).|Baseline and up to 52 weeks after the start of administration|Treated Set|||mL||Standard Error|Least Squares Mean
2565363|NCT02597933|Secondary|Annual Rate of Decline in FVC in Percentage (%) Predicted Over 52 Weeks|"Annual rate of decline in FVC in percentage (%) predicted over 52 weeks.~For this endpoint reported means represent the adjusted rate."|up to 52 weeks after the start of administration|Treated set|||% predicted/yr||Standard Error|Mean
2565364|NCT02597933|Secondary|Absolute Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 52.|"This is the second key secondary endpoint.~The Saint George's Respiratory Questionnaire measures the health status in patients with chronic airflow limitation. It consists of 2 parts that cover 3 domains: symptoms, activities, and impacts. The symptom domain relates to the effect, frequency and severity of respiratory symptoms. The activity domain relates to activities that cause or are limited by breathlessness. The impact domain evaluates a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. The scores of these domains range from 0 (no impairment) to 100 (worst possible). The calculated total score summarises the impact of the disease on overall health status. A high score corresponds to worse health.~Least square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52)."|Baseline and up to 52 weeks after the start of administration|Treated set|||unit on scale||Standard Error|Least Squares Mean
2565365|NCT02597933|Secondary|Absolute Change From Baseline in the Modified Rodnan Skin Score (mRSS) at Week 52|"This is the first key secondary endpoint.~The modified Rodnan Skin Score (mRSS) is an evaluation of the patient's skin thickness rated by clinical palpation using a 0 to 3 scale. The scale differentiates between 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness with inability to pinch the skin into a fold.~The palpation is done for each of the 17 surface anatomic areas of the body: face, anterior chest, abdomen, fingers (right and left separately), forearms, upper arms, thighs, lower legs, dorsum of hands and feet. The sum of these individual values is defined as the total skin score. The mRSS has a range from 0 (no thickening) to 51 (severe thickening in all 17 areas). A high score corresponds to worse skin thickness.~Least square mean is actually the adjusted mean. Adjusted mean was based on all analysed patients in the model (not only patients with a baseline and measurement at Week 52)."|Baseline and up to 52 weeks after the start of administration|Treated Set|||unit on scale||Standard Error|Least Squares Mean
2565366|NCT02597933|Primary|Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks|"Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.~For this endpoint reported means represent the adjusted rate."|up to week (wk) 52 after the start of administration|Treated Set|||millilitre (mL)/year (yr)||Standard Error|Mean
2565367|NCT02597920|Secondary|Description of PACT-Q1 Items for Patients in Cohort B at Baseline|The PACT-Q1 is composed of a single dimension (7 items), covering the expectations of patients regarding their anticoagulant treatment, and was to be administered before treatment initiation. The 7 items are: A1: How confident are you that your anticoagulant treatment will prevent blood clots? A2: Do you expect that your anticoagulant treatment will relieve some of the symptoms you experience? A3: Do you expect that your anticoagulant treatment will cause side effects such as minor bruises or bleeding? A4: How important is it for you to have an anticoagulant treatment that is easy to take? A5: How concerned are you about making mistakes when taking your anticoagulant treatment? A6: How important is it for you to take care of your anticoagulant treatment by yourself? A7: How concerned are you about how much you pay for your anticoagulant treatment? Responses ranged from 1 (Not at all) to 5 (Extremely/ Completely/ Very much).|Baseline|Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible. PACT-Q1 score at Visit 1 obtained after discontinuation of treatment or using incorrect procedure was excluded from the summary.|||Units on scale||Standard Deviation|Mean
2565368|NCT02597920|Secondary|Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment|The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).|Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).|Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible. PACT-Q2 score obtained after discontinuation of treatment or using incorrect procedure was excluded from the summary for that particular visit.|||Units on Scale||Standard Deviation|Mean
2565369|NCT02597920|Primary|Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration|Vitamin K Antagonist (VKA) treatment duration at baseline is only applicable for Cohort A patients and is one of the baseline patient characteristics.|Baseline|Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.|||Years||Standard Deviation|Mean
2565371|NCT02597920|Primary|Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score|CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. CHA2DS2-VASc stroke risk score and HAS-BLED bleeding risk score at baseline are patient characteristics.|Baseline|Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.|||Units on scale||Standard Deviation|Mean
2565372|NCT02597920|Primary|Patient Characterization at Baseline - Categorical Parameters|Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history and at baseline (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP).|Baseline|Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.|||Percentage of participants|||Number
2565373|NCT02597920|Primary|Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups|The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching method is used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group are summarized and used for comparison.|Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).|Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible. PACT-Q2 score obtained after discontinuation of treatment or using incorrect procedure was excluded from the summary for that particular visit.|||Units on Scale||Standard Deviation|Mean
2565374|NCT02597920|Primary|Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment|The PACT-Q is a self-administered questionnaire which was developed as a means to investigate patients´ satisfaction with anticoagulant treatment and treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score (CDS). Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores are more favorable. The two dimension scores are presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).|Baseline, Visit 2 (7-124 days after initiation on Pradaxa® or VKA), Visit 3 (125-365 days after initiation on Pradaxa® or VKA).|Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible. PACT-Q2 score obtained after discontinuation of treatment or using incorrect procedure was excluded from the summary for that particular visit.|||Units on Scale||Standard Deviation|Mean
2565375|NCT02597907|Primary|The Incidence of Postoperative Nausea and Vomiting|The incidence of postoperative nausea and vomiting during 24 hours postoperatively|24 hours||||Participants|||Count of Participants
2565376|NCT02597855|Secondary|Best Corrected Visual Acuity|Best corrected visual acuity assessed at baseline, 3 months, and 6 months|baseline, 3 months, and 6 monthsc|Participants who were finished 6 months follow up period.|||LogMAR||Standard Deviation|Mean
2565377|NCT02597855|Primary|Regression Rate of Polyp on Indocyanine Green Angiography|Indocyanine green angiography performed initially and at 3 months were used to determine the polyp regression. The definition of complete polyp regression is that the polyps at initial visit disappeared at 3 months on indocyanine green angiography. The partial regression means the polyps remain, but the size decreased >30%.|3 months|Participants who were finished 6 months follow up period.|||participants|||Number
2565378|NCT02597582|Secondary|Postoperative Injected Analgesic Amount|The amount of injected form analgesic used (Meperidine 50 mg/ampule)|2 weeks||||Ampule||Standard Deviation|Mean
2565379|NCT02597582|Secondary|Postoperative Oral Analgesic Consumption|The amount of analgesic consumption via oral ingestion after operation|2 weeks||||capsules||Standard Deviation|Mean
2565380|NCT02597582|Secondary|Postoperative Subjective Pain Status|Visual analogue scale of subjective pain status after operation|2 weeks|Pain visual analogue scale (VAS) (no pain: 0, intolerable pain: 10)|||units on a scale||Standard Deviation|Mean
2565381|NCT02597582|Secondary|Postoperative Drainage Amount|The amount of drainage from closed system drainage tube|2 weeks||||ml||Standard Deviation|Mean
2565382|NCT02597582|Secondary|Intraoperative Blood Loss|Intraoperative blood loss was estimated by the sum of the volume in the suction bottle and the increased weight of wet gauzes containing blood after neck dissection.|1 day||||ml||Standard Deviation|Mean
2565383|NCT02597582|Primary|Opreation Duration|The duration from incision of cervial skin till the completion of lymph node dissection|1 day||||minutes||Standard Deviation|Mean
2565384|NCT02597543|Secondary|Mean Segmental T1 Values of the Left Ventricle|T1 values are obtained at the time of the cardiac MRI and indicate the amount of myocardial edema. This was a one time measurement. Outcome measure time frame indicates when T1 values of the left ventricle were obtained in relation to heart-transplantation.|Range of 1 to 12 years after heart transplantation for subjects and an average of 4 years after heart-transplantation.||||Percentage of myocardium||Standard Deviation|Mean
2565390|NCT02597452|Secondary|Post-stratification of the Analysis of the Reliability by Breast Imaging Reporting and Data System Level|breakdown of the iBE clinically relevant findings and negative findings by the BIRAD levels determination from the gold standard final results|through study completion an average of 18 months|The specificity of iBE relevant findings (BIRADs 0, 3-5) vs benign findings (BIRADS 1, 2) from the results of mammography|||Participants|||Count of Participants
2565391|NCT02597452|Secondary|Inter-rate Reliability of the iBE and the CBE Position of Lesions Detected|comparing the position(s) results of two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam|through study completion an average of 18 months|Difficulty enrolling patients for this outcome as a result of the participants undergoing the iBE and CBE twice by two different healthcare professionals. Subjects declined to continue after first healthcare professional exams was complete. Comparison data between healthcare professionals was not available to analyze.||||||
2565392|NCT02597452|Secondary|Inter-rate Reliability of the iBE and the CBE Number of Lesions Detected|comparing the number of breast lesions detected two independent healthcare professionals consecutive evaluations of the same patient with the iBE device and clinical breast exam|through study completion an average of 18 months|Difficulty enrolling patients for this outcome as a result of the participants undergoing the iBE and CBE twice by two different healthcare professionals. Subjects declined to continue after first healthcare professional exams was complete. Comparison data between healthcare professionals was not available to analyze.||||||
2565393|NCT02597452|Secondary|Size Detection of the Breast Lesions Identified by iBE|The size detected of the breast lesion (cm) by mammogram or ultrasound|approximately one month after imaging|The size was not measured by iBE. Only 4 of the 7 lesions were detected by iBE and size data was not available to analyze.||||lesions||
2565394|NCT02597452|Secondary|Position of the Breast Lesion as Measured by iBE and Mammography|agreement of the position of the lesion, defined by time coordinate measured by iBE and mammography or ultrasound that fall within a 3 hour time quadrants on a clock of each other.|approximately one month after imaging|Number of subjects who had a lesion identified by iBE and mammogram, ultrasound, or MRI.|||lesions|lesions||Count of Units
2565395|NCT02597452|Primary|Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results|comparing the calculated the specificities or the percentage of true negative lesions (based on imaging results) of the iBE and CBE|approximately one month after imaging||||percentage of true negative lesions|||Number
2565396|NCT02597452|Primary|Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results|comparing the calculated the sensitivities or the percentage of true positive breast lesions (based on imaging results) of the iBE and CBE|approximately one month after imaging scan||||percentage of true positive lesions|||Number
2565397|NCT02597127|Secondary|Percentage Change in Other Lipids and Inflammatory Markers From Baseline to Day 180|This outcome measure evaluated the percent change from baseline to Day 180 in triglycerides, very-low-density lipoprotein (VLDL) cholesterol, lipoprotein(a), and high sensitivity C-reactive protein (hsCRP) in participants (single and double dose) in the mITT population.|Baseline, Day 180||||percent change||Inter-Quartile Range|Median
2565398|NCT02597127|Secondary|Number of Participants Who Attained Global Lipid Modification Targets for Level of Atherosclerotic Cardiovascular Disease Risk|"This outcome measure evaluated the proportion of participants (single and double dose) in the mITT population who attained a global lipid modification target by baseline cardiovascular risk group, looking specifically at LDL-C levels (mg/dL) in the category of cardiovascular disease (CVD).~CVD was defined as a participant who had at least 1 of the following: prior myocardial infarction, prior percutaneous coronary intervention, prior coronary artery bypass graft, prior stroke, prior transient ischemic attack, peripheral artery disease."|Baseline, Day 180||||Participants|||Count of Participants
2565399|NCT02597127|Secondary|Percentage Change in Other Lipids and Apolipoproteins From Baseline to Day 180|This outcome measure evaluated the percent change from baseline to Day 180 in cholesterol (total, high-density lipoprotein [HDL], non-HDL) and apolipoproteins (B, A1) in participants (single and double dose) in the mITT population.|Baseline, Day 180||||percent change||Standard Deviation|Mean
2565400|NCT02597127|Secondary|Percentage Change in PCSK9 Levels From Baseline at Day 180|This outcome measure evaluated the percent change in proprotein convertase subtilisin/kexin type 9 (PCSK9) from baseline to Day 180 in participants (single and double dose) in the mITT population.|Baseline, Day 180||||percent change||Standard Deviation|Mean
2565401|NCT02597127|Secondary|Number of Participants With Greater Or Equal To 50% LDL-C Reduction From Baseline At Day 180|This outcome measure evaluated the number of participants (single and double dose) in the mITT population with an LDL-C reduction greater than 50% of the baseline value at Day 180.|Baseline, Day 180||||Participants|||Count of Participants
2565402|NCT02597127|Secondary|Number of Participants With Individual Responsiveness as Measured By LDL-C Levels at Day 90 and Day 180|This outcome measure evaluated the individual responsiveness of participants to inclisiran (single and double dose) in the mITT population as defined by an LDL-C level of <25 mg/deciliter [dL] at Day 90 and Day 180.|Day 90, Day 180||||Participants|||Count of Participants
2565403|NCT02597127|Secondary|Number of Participants With an LDL-C Greater Than 80% of the Baseline Value at Day 180 and Day 210|This outcome measure evaluated the number of participants (single and double dose) in the mITT population with an LDL-C greater than 80% of the baseline value at Day 180 and Day 210.|Baseline, Day 180, Day 210||||Participants|||Count of Participants
2565404|NCT02597127|Secondary|Percent Change From Baseline In LDL-C Levels At Day 60, Day 120, and Day 210|This outcome measure evaluated the effects of both single- and double-dose inclisiran on LDL-C levels in the mITT population from baseline to Day 60, Day 120, and Day 210.|Baseline, Day 60, Day 120, and Day 210||||Percent change||95% Confidence Interval|Mean
2565405|NCT02597127|Secondary|Percentage Change in LDL-C From Baseline to Day 90|Percent Change in LDL-C (beta-quantification) from Baseline to Day 90 in MITT Population|Baseline to 90 days|In this analysis, the single and double-dose 200mg arms were combined, as were the single and double-dose 300mg arms. The second dose for patients in double-dose arms was given on Day 90. Therefore, up to day 90, those patients in double-dose arms received the same treatment as patients in the single dose arms within the same dose amount.|||Percent change||95% Confidence Interval|Least Squares Mean
2565408|NCT02597062|Secondary|Progression-free Survival|"Median time to progression or death assessed by biochemistry, radiology and immunology tests will be reported. Progression is evaluated in this study using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC) with any one or more of the following:~Increase of ≥ 25% from lowest response value in: Serum M-component and/or Urine M-component and/or Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels or Bone marrow plasma cell percentages.~Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL (0.115 g/L) or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder."|3 years|All treated patients were included in the analysis|||months||95% Confidence Interval|Median
2565409|NCT02597062|Primary|Overall Response Rate After 4 Cycles|"Response rate to protocol treatment after 4 cycles is define by stringent complete response, complete response, partial response, very good partial response, minimal response.~Complete response: Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow biopsy Stringent complete response: Complete response plus Absence of clonal cells in bone marrow d by immunohistochemistry or immunofluorescence Very good partial response: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein with urine M-protein level <100 mg/24 hours.~Partial response: ≥50% reduction in serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours Minimal response: 25-49% reduction in serum M-protein, and 50-89% reduction in 24-hour urinary M-protein, if ≥ 200 mg/24 hours at baseline"|4 months|All eligible patients how have received treatment.|||Participants|||Count of Participants
2565410|NCT02597049|Secondary|Number of Participants With Adjudicated Cardiovascular (CV) Events|Death and selected nonfatal CV adverse events (AEs) were adjudicated by an independent committee of physicians with cardiology expertise external to the Sponsor. Nonfatal CV events that were to be adjudicated were myocardial infarction (MI); hospitalization for unstable angina; hospitalization for heart failure; coronary interventions such as coronary artery bypass graft (CABG) or ( percutaneous coronary intervention (PCI); and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack (TIA).|Baseline through 24 Weeks|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2565411|NCT02597049|Secondary|Number of Participants With Adjudicated Acute Pancreatitis Events|"The number of participants with events of pancreatitis confirmed by adjudication were summarized cumulatively at 24 weeks. Pancreatitis events were adjudicated by a committee of physicians external to the Sponsor.~A summary of serious and other non-serious events regardless of causality is located in the Reported Adverse Events module."|Baseline through 24 Weeks|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2565412|NCT02597049|Secondary|Number of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia|Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.|Baseline through 24 Weeks|All participants who had at least one dose of study drug.|||Participants|||Count of Participants
2565413|NCT02597049|Secondary|Rate of Hypoglycemic Events Adjusted Per 30 Days|A hypoglycemic event is defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a PG level of ≤70 mg/dL (≤3.9 mmol/L).|Baseline through 24 Weeks|All participants who received at least one dose of study drug.|||Number of events/participant/30 days||Standard Deviation|Mean
2565414|NCT02597049|Secondary|Change From Baseline in Fasting Glucagon at 24 Weeks|Change from baseline in fasting glucagon was analyzed using an ANCOVA model with last observation carried forward (LOCF) included in treatment, country, SGLT2i dose, metformin use, and baseline HbA1c strata as fixed effects and baseline fasting glucagon as a covariate (with and without post rescue data).|Baseline, Week 24|All participants who received at least one dose of study drug and with non-missing baseline values and at least one post-baseline value at the specified time point.|||picomole per liter (pmol/L)||Standard Error|Least Squares Mean
2565415|NCT02597049|Secondary|Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks|The self-monitored plasma glucose (SMPG) data were collected at the following 6 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, metformin use, SGLT2 inhibitor use, country, visit, baseline HbA1c strata, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, Week 24|All participants who received at least one dose of study drug and had baseline SMPG value and at least one post-baseline SMPG value.|||mg/dL||Standard Error|Least Squares Mean
2565416|NCT02597049|Secondary|Change From Baseline in Fasting Serum Glucose (Central Laboratory) at 24 Weeks|LS mean of change from baseline was calculated using last observation carried forward (LOCF) by treatment group, adjusted for treatment, country, SGLT2 inhibitor dose, metformin use, baseline HbA1c strata, and baseline fasting serum glucose using analysis of covariance (ANCOVA).|Baseline, Week 24|All participants who received at least one dose of study drug and had baseline and at least one post-baseline value.|||milligram/deciliter (mg/dL)||Standard Error|Least Squares Mean
2565417|NCT02597049|Secondary|Change From Baseline in Body Weight at 24 Weeks|LS mean of the body weight change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, baseline HbA1c strata, treatment-by-visit interactions as fixed effects, and baseline body weight as a covariate and participant as a random effect, via a MMRM analysis|Baseline, Week 24|All participants who received at least one dose of study drug.|||kilograms (kg)||Standard Error|Least Squares Mean
2565418|NCT02597049|Secondary|Percentage of Participants With HbA1c <7%|Number of participants with an HbA1c value of <7% at Week 24 is measured using longitudinal logistic regression with repeated measurements. The model will include independent variables of treatment, country, SGLT2 inhibitor dose, metformin use, visit, treatment-by-visit interaction, and baseline HbA1c as a covariate.|24 Weeks|All participants who received at least one dose of Dulaglutide with HbA1c <7% at Week 24.|||percentage of participants|||Number
2565419|NCT02597049|Primary|Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)|LS mean of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The efficacy estimand excluded post-rescue data and compared the benefit of randomized treatments when taken as directed without rescue medication.|Baseline, Week 24|All randomized participants who received at least one dose of study drug and had a baseline and post-baseline value excluding values collected after rescue medication.|||percentage of HbA1c||Standard Error|Least Squares Mean
2565420|NCT02597049|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)|Least Squares mean (LS) of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The treatment-regimen estimand used all data including post-rescue data and compared the benefit of treatment regimens as they were actually taken.|Baseline, Week 24|All randomized participants who received at least one dose of study medication and had evaluable data.|||percentage of HbA1c||Standard Error|Least Squares Mean
2565421|NCT02596971|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab|"Atezo-G-CHOP: Induction: Predose on D1 of Cy2,3,5,6 (1 Cy: 21 days); Maintenance: Predose on D1 of Month 1,2,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years); Atezo-R-CHOP: Predose on D1 of Cy 2,3,5,8,16,25 (1 Cy: 21 days); at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years). Predose time point was any time prior to dose for Cycles 2,3,5,6,8 during induction phase, for Cycles 16,25 during consolidation treatment, and for Months 1 to 24 during maintenance phase."|Atezo-G-Benda: Induction: Predose on D1 of Cy2,3,5,6 (1Cy: 28 days), Cy3D15: Predose; Maintenance: Predose on D1 of Month 1,4,7,15,23; at 120 days and 1 year of last atezolizumab dose or at treatment discontinuation (up to 4 years)|The analysis population consisted of all participants who received at least one dose of study drug.|||percentage of participants|||Number
2565422|NCT02596971|Secondary|Percentage of Participants With Human Anti-Chimeric Antibodies (HACAs) to Rituximab||Induction: Predose (any time prior to dose) on D1 of Cy2,3,5,8 (1Cy: 21 days); Maintenance: Predose (any time prior to dose) on D1 of Month 1; at 120 days and 1 year of last rituximab dose or at treatment discontinuation (up to 4 years)|The safety analysis population consisted of all participants who received at least one dose of study drug in the Atezo-R-CHOP cohort.|||percentage of participants|||Number
2565423|NCT02596971|Secondary|Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab||Induction: Predose (any time prior to dose) on D1 of Cy1,5,6 (1Cy: 21/28 days); Maintenance: Predose (any time prior to dose) on D1 of Month 1; at 120 days and 1 year of last obinutuzumab dose or at treatment discontinuation (up to 4 years)|The safety analysis population consisted of all participants who received at least one dose of study drug in the Atezo-G-Benda cohort|||percentage of participants|||Number
2565424|NCT02596971|Secondary|Observed Serum Rituximab Concentration|"Predose time point was any time prior to dose for Cycle 1 and within 5 hour prior to dose for other cycles (Cycles 2,5,8) during induction phase and for Months 1 to 24 during maintenance phase. Infusion duration for administration of first infusion should begin at an initial rate of 50 mg/hour. If no infusion-related or hypersensitivity reaction occurs, increase the infusion rate in 50 mg/hour increments every 30 minutes to a maximum of 400 mg/hour. If no reaction occurs, increase the infusion rate in 100 mg/hour increments every 30 minutes to a maximum of 400 mg/hour."|Predose, 0.5h postinfusion on D1 of Cy1,2,5,8 (1Cy: 21 days); at 120 days and 1 year after last rituximab dose or at treatment discontinuation (up to 4 years)||2021-04-30|04/2021||||
2565425|NCT02596971|Secondary|Observed Serum Atezolizumab Concentration|"Atezo-G-Benda: Induction:Predose on D1 of Cy5,6 & D1,15 of Cy2,3 (1Cy:21/28 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years); Atezo-G-CHOP: Induction:Predose on D1 of Cy2,3,5,6 (1Cy:21 days), Cy2D1:0.5h postinfusion; Maintenance:Predose on D1 of Month 1,2,3,4,7,15,23, Month 2 D1: 0.5h postinfusion; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years). Predose time point was within 5 hour prior to dose for Cy2,3,5,6 during induction phase and for Months 1 to 24 during maintenance phase. infusion length: 30-60 minutes."|Atezo-R-CHOP: Predose on D1 of Cy2,3,5,8,9,10,11,12,16,20,25 (1Cy:21 days), 0.5h postinfusion of D1 of Cy2,9; at 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years)||2021-04-30|04/2021||||
2565426|NCT02596971|Secondary|Observed Serum Obinutuzumab Concentration|"Predose time point was any time prior to dose for Cycle (Cy) 1 and within 5 hour prior to dose for other cycles (Cy 2,5,6) and for Months 1 to 24 during maintenance phase. Infusion duration for administration of first infusion should begin at an initial rate of 50 milligrams per hour (mg/hour). If no reaction occurs, increase the infusion rate in 100 mg/hour increments every 30 minutes to a maximum of 400 mg/hour."|Induction: Predose, 0.5 hour (h) postinfusion on Day (D) 1 of Cy1,2,5,6 (1Cy: 21/28 days); Maintenance: Predose, 0.5h postinfusion on Day 1 of Month 1,3,7,15,23; 120 days & 1 year of last dose or at treatment discontinuation (up to 4 years)||2021-04-30|04/2021||||
2565427|NCT02596971|Secondary|Percentage of Participants With Best Response of CR or PR During Study, as Determined by Investigator Using Modified Cheson 2007 Criteria||Baseline up to approximately 4 years (assessed at Baseline, 6 to 8 weeks after Day [D] 1 of Cycle [Cy] 6 or 8 (1Cy: 21 or 28 days), then every 2 months up to 24 months, at 35 days of last dose, and at every 3 months post-treatment follow-up [up 4 years])||2020-04-30|04/2020||||
2565441|NCT02596958|Secondary|Percentage of Participants With Eastern Cooperative Group(ECOG) Performance Status Grades|ECOG Performance Status measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0 is equal to (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50% of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.|||percentage of participants|||Number
2565428|NCT02596971|Secondary|Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Lugano 2014 Criteria|Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT scan. OR: a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes & extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR with a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.|Up to approximately 6 months|Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab).|||percentage of participants||90% Confidence Interval|Number
2565429|NCT02596971|Secondary|Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Lugano 2014 Criteria|Tumor response assessment was performed by IRC according to modified Lugano classification using PET/CT scan. OR defined as a response of CR or PR. CR: a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with/without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR: a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.|Up to approximately 6 months|Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab).|||percentage of participants||90% Confidence Interval|Number
2565430|NCT02596971|Secondary|Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria|Objective response: having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.|Up to approximately 6 months|Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab).|||percentage of participants||90% Confidence Interval|Number
2565431|NCT02596971|Secondary|Percentage of Participants With Objective Response (CR or PR) at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria|Objective response: having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All positron emission tomography (PET) evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.|Up to approximately 6 months|Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab).|||percentage of participants||90% Confidence Interval|Number
2565432|NCT02596971|Secondary|Percentage of Participants With CR at EOI, as Determined by the Investigator Using Modified Cheson 2007 Criteria|Complete response according to modified Cheson 2007 criteria using PET/CT scan: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population. Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy.|Up to approximately 6 months|Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab).|||percentage of participants||90% Confidence Interval|Number
2565475|NCT02596321|Secondary|D. Pteronyssinus Specific IgG4 Change From Baseline to End of Treatment|secondary endpoint of D. pteronyssinus specific IgG4 change from baseline to end of treatment|60 days from baseline||||mg antibody/ml||Standard Deviation|Mean
2565476|NCT02596321|Primary|D. Farinae Specific IgG4 Change From Baseline to End of Treatment|primary efficacy endpoint of D. Farinae specific IgG4 change from baseline to end of treatment|60 days from baseline||||mg antibody/ml||Standard Deviation|Mean
2565433|NCT02596971|Secondary|Percentage of Participants With CR at EOI, as Determined by the IRC Using Modified Cheson 2007 Criteria|Complete response according to the modified Cheson 2007 criteria using PET/CT scan: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. Partial Response (PR): at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.|Up to approximately 6 months|Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab).|||percentage of participants||90% Confidence Interval|Number
2565434|NCT02596971|Secondary|Percentage of Participants With CR at EOI, as Determined by the Investigator Using Lugano 2014 Criteria|Tumor response assessment was performed by the investigator according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. 90% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.|Up to approximately 6 months|Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of r/r FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab).|||percentage of participants||90% Confidence Interval|Number
2565435|NCT02596971|Primary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline up to approximately 4 years|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.|||percentage of participants|||Number
2565436|NCT02596971|Primary|Percentage of Participants With Complete Response (CR) at End of Induction (EOI), as Determined by the Independent Review Committee (IRC) Using Modified Lugano 2014 Criteria|Primary end point was positron emission tomography (PET) CR at EOI by IRC according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to [</=] mediastinum), or 3 (uptake less than [<] mediastinum but </=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites; no new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. All PET evaluable 1L FL and 1L DLBCL patients with at least one dose of atezolizumab were included in efficacy population.|Up to approximately 6 months|Only Atezo-G-Benda and Atezo-R-Chop cohorts were evaluated for efficacy. 2 participants excluded from Atezo-G-Benda cohort (diagnosis of relapsed/refractory [r/r] FL). 2 participants excluded in R-Chop-Atezo cohort (they were excluded prior to Cycle 2, were not treated with atezolizumab).|||percentage of participants||90% Confidence Interval|Number
2565437|NCT02596958|Secondary|Overall Survival|Overall survival was defined as the time (months) between the start of therapy and the date of death.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here 'number of participants analyzed' = participants assessed for this outcome measure.|||months||Standard Deviation|Mean
2565438|NCT02596958|Secondary|Percentage of Participants Who Died||Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.|||percentage of participants|||Number
2565439|NCT02596958|Secondary|Progression Free Survival (PFS)|PFS was defined as the time (months) between the start of therapy and progression (unequivocal progression of existing non-target lesions) or death. Progression: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started. PFS was estimated using Kaplan-Meier method.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.|||months||95% Confidence Interval|Median
2565440|NCT02596958|Secondary|Percentage of Participants With Disease Control|Disease control was defined as having achieved CR (commonly defined as disappearance of all target lesions, all non-target lesions, and no new lesion), PR (commonly defined as at least a 30% decrease in the sum of the LD of target lesions, no progression in non-target lesion, and no new lesion), or SD (commonly defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, in addition to no new target lesions) during the course of observation which were assessed as per investigator discretion. PD: commonly defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started and NE.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.|||percentage of participants|||Number
2565492|NCT02596022|Primary|Number of Choices to Self-administer Cocaine (Out of 5 Choices)|Participants provided 5 choices (cocaine 25 mg now vs. $11 later), with choices spaces 15 minutes apart over the course of the session.|24 hours post-infusion||||number of cocaine choices||Standard Deviation|Mean
2565442|NCT02596958|Secondary|Percentage of Participants With Best Tumor Response Over Time|Best tumor response (assessed as per clinical routine of the individual center) was categorized according to the following criteria at the investigator discretion: complete response (CR: commonly defined as disappearance of all target lesions, all non-target lesions, and no new lesion), partial response (PR: commonly defined as at least a 30 percent [%] decrease in the sum of the longest diameter [LD] of target lesions, no progression in non-target lesion, and no new lesion), stable disease (SD: commonly defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD], in addition to no new target lesions). PD: commonly defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started and not evaluable (NE).|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it. Here, number of participants analyzed = participants with non-missing tumor response data.|||percentage of participants|||Number
2565443|NCT02596958|Secondary|Number of Cycles of Systemic Therapy|Number of cycles of systemic therapy was the mean number of cycles received by participants in combination therapy with Avastin and chemotherapy and with Avastin monotherapy (maintenance).|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it.|||cycles||Standard Deviation|Mean
2565444|NCT02596958|Secondary|Percentage of Participants Who Withdrew or Modified Treatment|Percentage of participants who withdrew treatment or experienced at least 1 dose deviation in relation to the planned Avastin therapy were reported.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it.|||percentage of participants|||Number
2565445|NCT02596958|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs), Toxicities, Avastin-Related ADRs, and Serious ADRs|ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. Serious ADRs were defined as any untoward medical occurrence or effect that at any dose resulted in death or life-threatening conditions or required hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect or medically important condition. Toxicity was defined as an adverse event that had an attribution (the relationship to investigational agent) of possible, probable or definite. Avastin-related ADRs (an adverse event with a possible relationship or a relationship to the treatment with AVASTIN) were due to Avastin. ADRs includes serious as well as non-serious ADRs.|Up to 74 months|Analysis population was defined as all participants included in the observational study, regardless of whether they finished it or not.|||percentage of participants|||Number
2565446|NCT02596945|Secondary|Average Duration in Days Mircera Was Administered at a Stable Dose||Up to 9 months|MES population.|||days||Standard Deviation|Mean
2565447|NCT02596945|Secondary|Percentage of Participants With Hemoglobin Values in the Range of 11-13 g/dL During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)||Month 7 to Month 9|MES population.|||percentage of participants|||Number
2565448|NCT02596945|Primary|Percentage of Participants With Hemoglobin Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)||Month 7 to Month 9|Modified Efficacy Set (MES) population (All participants who received at least 1 dose of study drug and for whom at least 2 hemoglobin measurements were available during the evaluation period (Month 7 to Month 9).|||percentage of participants|||Number
2565449|NCT02596893|Primary|The Percentage of Participants Who Achieved a Clinical Remission at Week 12|Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score < 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the affect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.|Week 12|ITT population; includes participants who had either completed that timepoint visit or discontinued at any time due to reasons other than study terminated by sponsor; the Non-responder Imputation (NRI)|||Percentage of Participants||95% Confidence Interval|Number
2565450|NCT02596893|Secondary|The Number of Participants Who Discontinued IP Due to an Treatment Emergent Adverse Events|A TEAE was defined as any AE occurring or worsening on or after the first dose of GED-0301 and up to 28 days after the last GED-0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain.|From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 52.6 weeks|The safety population consisted of all participants who were randomized and received at least 1 dose of IP|||participants|||Number
2565451|NCT02596893|Secondary|The Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE) From Week 0 to Week 52|A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of GED-0301 and up to 28 days after the last GED-0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.|From the first day of GED-0301 until 28 days after the last dose of investigational product (IP); maximum treatment duration was 52.6 weeks|The safety population consisted of all participants who were randomized and received at least 1 dose of IP.|||Participants|||Count of Participants
2565505|NCT02595970|Secondary|DLQI (Dermatology Life Quality Index) Over Time|"DLQI score has a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired~MEANING OF DLQI SCORES 0 - 1 no effect on patient's life 2 - 5 small effect on patient's life 6 - 10 moderate effect on patient's life 11 - 20 very large effect on patient's life 21 - 30 extremely large effect on patient's life"|weeks 0, 16, 52|Full Analysis Set (observed)|||DLQI score (range : 0 - 30)||Standard Deviation|Mean
2565452|NCT02596893|Secondary|Percentage of Participants With Endoscopic Remission Centrally Read at Week 52|"Endoscopic remission is defined as a simple endoscopic score for Crohn's disease (SES-CD) of ≤2 at the specified timeframe. The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include:~Ulcers scored as:~0: no~aphthous (0.1-0.5 cm)~large (0.5-2 cm)~very large (>2 cm)~Surface involved disease 0: 0%~<50%~50-75%~>75%~Surface involved by ulcerations:~0: 0%~<10%~10-30%~>30% - Narrowings:~0: No~Single, can be passed~Multiple, can be passed~Cannot be passed Grand Total = SES-CD score"|Week 52|ITT population; includes participants who had either completed that timepoint visit or discontinued at any time due to reasons other than study terminated by sponsor. NRI.|||percentage of participants||95% Confidence Interval|Number
2565453|NCT02596893|Secondary|Percentage of Participants With Endoscopic Response-25 Centrally Read at Week 12|"An endoscopic response-25 is defined as a reduction of at least 25% compared with baseline in simple endoscopic score for Crohn's disease (SES-CD). The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include:~Ulcers scored as:~0: no~aphthous (0.1-0.5 cm)~large (0.5-2 cm)~very large (>2 cm)~Surface involved disease 0: 0%~<50%~50-75%~>75%~Surface involved by ulcerations:~0: 0%~<10%~10-30%~>30% - Narrowings:~0: No~Single, can be passed~Multiple, can be passed~Cannot be passed Grand Total = SES-CD score"|Week 0, Week 12|ITT population; includes participants who had either completed that timepoint visit or discontinued at any time due to reasons other than study terminated by sponsor. NRI.|||percentage of participants||95% Confidence Interval|Number
2565454|NCT02596893|Secondary|Percentage of Participants Who Achieved a Sustained Clinical Remission at Both Week 12 and 52|For participants who achieved a sustained clinical remission at both week 12 and 52, the clinical remission is a CDAI score < 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.|Weeks 12 and 52|ITT population; includes participants who had either completed that timepoint visit or discontinued at any time due to reasons other than study terminated by sponsor. NRI.|||percentage of participants||95% Confidence Interval|Number
2565455|NCT02596893|Secondary|The Percentage of Participants Who Achieved a Corticosteroid-Free Clinical Remission at Week 52|The percentage of participants who were receiving oral corticosteroids for Crohn's disease, at baseline and achieved a clinical remission (CDAI score <150) at Week 52 without corticosteroids. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.|Week 52|ITT population; includes participants who received oral corticosteroids at baseline and had either completed that timepoint visit or discontinued at any time due to reasons other than study terminated by sponsor. NRI.|||percentage of participants||95% Confidence Interval|Number
2565456|NCT02596893|Secondary|The Percentage of Participants Who Achieved a Clinical Remission at Week 4|A clinical remission is a CDAI score < 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.|Week 4|ITT population; includes participants who had either completed that timepoint visit or discontinued at any time due to reasons other than study terminated by sponsor. NRI.|||percentage of participants||95% Confidence Interval|Number
2565457|NCT02596893|Secondary|The Percentage of Participants Who Achieved a Clinical Response at Week 4|A clinical response is defined as a decrease from baseline in CDAI ≥ 100 points. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.|Week 4|ITT Population; includes participants who had either completed that timepoint visit or discontinued at any time due to reasons other than study terminated by sponsor. NRI.|||percentage of participants||95% Confidence Interval|Number
2565458|NCT02596893|Secondary|The Percentage of Participants Who Achieved a Clinical Response at Week 12|A clinical response is defined as a CDAI score decrease from baseline ≥ 100 points. The CDAI is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.|Week 12|ITT population; Includes participants who had either completed that timepoint visit or discontinued at any time due to reasons other than study terminated by sponsor. NRI.|||percentage of participants||95% Confidence Interval|Number
2565459|NCT02596893|Secondary|Percentage of Participants With Endoscopic Response-50 Centrally Read at Week 52|"An endoscopic response-50 is defined as a reduction of at least 50% compared with baseline in simple endoscopic score for Crohn's Disease (SES-CD). The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include:~Ulcers scored as:~0: no~aphthous (0.1-0.5 cm)~large (0.5-2 cm)~very large (>2 cm)~Surface involved disease 0: 0%~<50%~50-75%~>75%~Surface involved by ulcerations:~0: 0%~<10%~10-30%~>30% - Narrowings:~0: No~Single, can be passed~Multiple, can be passed~Cannot be passed Grand Total = SES-CD score"|Week 52|ITT population; Includes participants who had either completed that timepoint visit or discontinued at any time due to reasons other than study terminated by sponsor. NRI.|||percentage of participants||95% Confidence Interval|Number
2565693|NCT02590588|Secondary|Evaluate Safety and Tolerability of Agent|Number of Participants With Treatment-Related Adverse Events as Assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0|3 months|There was only one patient enrolled and he did experience treatment-related adverse events.|||Participants|||Count of Participants
2565460|NCT02596893|Secondary|Percentage of Participants Who Achieved Clinical Remission at Week 52|Clinical remission is defined as a CDAI score < 150 and is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.|Week 52|ITT population; Includes participants who had either completed that timepoint visit or discontinued at any time due to reasons other than study terminated by sponsor. NRI.|||percentage of participants||95% Confidence Interval|Number
2565461|NCT02596867|Secondary|Assess the Safety, Toxicity and Adherence to Propranolol.|Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.(Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4)|3 weeks|Two patients with breast cancer are included in this analysis. One patient was a stage I breast cancer and the second patient was a stage III breast cancer, AEs were assessed during and after treatment|||Participants|||Count of Participants
2565462|NCT02596867|Primary|Evaluate the Effect of the Beta Blocker Propranolol on Reducing the Tumor Proliferative Index Using Ki-67.|to evaluate effect of beta adrenergic blockades on breast cancer at by Ki67 percentage change- we are looking at at least 10% mean change in the tumor proliferative index following propranolol treatment|3 weeks|Two patients with breast cancer are included in this analysis. One patient was a stage I breast cancer and the second patient was a stage III breast cancer.|||% mean difference of Ki67|||Number
2565463|NCT02596854|Primary|Mean Diagnostic Image Quality Difference Between Conventional Versus Synthetic MR Utilizing a 5 Point Likert Scale|Images were read by board-certified radiologists who reviewed each image and assessed it on a 5 Point scale (1=unacceptable, 2=poor image quality, 3=Acceptable, 4=Good, 5=Excellent) based on the quality of the image (eg, signal-to-noise, clarity of anatomic boundaries, and other parameters). The outcome was reported as the mean diagnostic image quality score difference (synthetic - conventional).|1 day|Clinical indication for MRI of the brain based on site standard of care. This is a crossover study design where all subjects are enrolled into a single group producing two data types. The hypothesis test is a function of conventional and post-processed image quality within this patient group (one value summarized for this single population).|||units on a 5-point scale||Standard Deviation|Mean
2565464|NCT02596750|Primary|Visual Analog Scale Pain|"100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity."|30 min|All participants|||Units on a Scale|Forearm|Standard Deviation|Mean
2565465|NCT02596750|Primary|Visual Analog Scale Pain|"100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity."|10 min|All participants|||Units on a Scale|Forearm|Standard Deviation|Mean
2565466|NCT02596750|Primary|Visual Analog Scale Pain|"100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity."|5 min|All participants|||Units on a Scale|Forearm|Standard Deviation|Mean
2565467|NCT02596750|Primary|Visual Analog Scale Pain|"100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity."|2 min|All participants|||Units on a Scale|Forearms|Standard Deviation|Mean
2565468|NCT02596711|Primary|Number of Abstinent Participants|Rates of biochemically verified 7-day point prevalence smoking abstinence. Collected with the Timeline Follow-back interview procedure and verified with a expired carbon monoxide testing with a Bedfont Smokelyzer monitor.|Collected at the 3- and 6-month follow-up visits||||Participants|||Count of Participants
2565469|NCT02596711|Primary|Patch Adherence: Percentage of Days With Patch|Adherence to NRT patch (days of NRT patch use) collected with the Timeline followback interview procedure.|This outcome was collected at each study timepoint and measured the 12 weeks of NRT patch treatment.||||percentage of NRT patch days||Standard Deviation|Mean
2565470|NCT02596711|Primary|Intervention Feasibility & Acceptability|"The central aim of this pilot study was to evaluate the feasibility and acceptability of our treatment interventions. As such, we examined between-group differences on session satisfaction. After completing each session, participants anonymously rated their level of satisfaction with the counseling session. This investigator created scale (Session Satisfaction Scale) used a 5-point Likert scale (from 1 = Extremely Unsatisfied to 5 = Extremely Satisfied). Mean satisfaction scores were computed for each participant as the average of all session satisfaction scores. Higher scores indicating greater levels of satisfaction. Treatment group session satisfaction group means were tabulated by group (calculated as the average for all participants in each treatment group) and used as a proxy measure of overall intervention acceptability and feasibility."|Averaged across 3 study visits (Week 0 to Week 12)||||score on a scale||Standard Deviation|Mean
2565471|NCT02596620|Primary|Percentage of Participants With Successful Eradication of H. Pylori|Successful eradication of H. pylori is defined as (1) negative results of both rapid urease test and histology, or (2) a negative result of urea breath test at 4 weeks.|Negative results of H.pylori 4 weeks after eradication||||percentage of eradication||95% Confidence Interval|Number
2565472|NCT02596451|Primary|Absolute Change in the Total WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Subscale Score for the Target Knee|The total WOMAC Pain Subscale score was determined by summing the individual scores from each of the five questions using a 5-point Likert scale (i.e., 'none'=0; 'mild'=1, 'moderate'=2; 'severe'=3; 'extreme'=4) comprising the WOMAC Pain Subscale Rating for the Target Knee.|Baseline and week 4||||units on a scale||Standard Deviation|Mean
2565473|NCT02596321|Secondary|D. Pteronyssinus Specific IgE Change From Baseline to End of Treatment|the secondary endpoint of D. pteronyssinus specific IgE change from baseline to end of treatment compared to placebo|60 days from baseline||||kUA/L||Standard Deviation|Mean
2565474|NCT02596321|Secondary|D. Farinae Specific IgE Change From Baseline to End of Treatment|the secondary endpoint of D. farinae specific IgE change from baseline to end of treatment compared to placebo|60 days from baseline||||kUA/L||Standard Deviation|Mean
2565477|NCT02596230|Secondary|Objective 2: Incidence Rate of All-cause Mortality|"Incidence rate of all-cause mortality per 100 patient-years (1/(100*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model.~For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation."|12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).|Restricted set: The restricted population was composed of all eligible patients, which lay within the region of propensity score overlap. The propensity scores are estimated after the multiple imputation is performed based on eligible patients who took the prescribed treatment at least once.|||events per 100 patient-years||95% Confidence Interval|Number
2565478|NCT02596230|Secondary|Objective 2: Incidence Rate of VTE-related Mortality|"Incidence rate of VTE-related Mortality per 100 patient-years (1/(100*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model.~For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation."|12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).|Restricted set: The restricted population was composed of all eligible patients, which lay within the region of propensity score overlap. The propensity scores are estimated after the multiple imputation is performed based on eligible patients who took the prescribed treatment at least once.|||events per 100 patient-years||95% Confidence Interval|Number
2565479|NCT02596230|Secondary|Objective 2: Incidence Rate of Recurrent DVT and/or PE|"Incidence rate of Recurrent Deep Vein Thrombosis (DVT) and/or Pulmonary Embolism (PE) per 100 patient-years (1/(100*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model.~For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation."|12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).|Restricted set: The restricted population was composed of all eligible patients, which lay within the region of propensity score overlap. The propensity scores are estimated after the multiple imputation is performed based on eligible patients who took the prescribed treatment at least once.|||events per 100 patient-years||95% Confidence Interval|Number
2565480|NCT02596230|Primary|Objective 2: Symptomatic Recurrent VTE (Venous Thromboembolism) Including VTE Related Mortality|"Incidence rate of Symptomatic Recurrent VTE (Venous Thromboembolism) including VTE related mortality per 100 patient-years (1/(100*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model.~For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation."|12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).|Restricted set: The restricted population was composed of all eligible patients, which lay within the region of propensity score overlap. The propensity scores are estimated after the multiple imputation is performed based on eligible patients who took the prescribed treatment at least once.|||events per 100 patient-years||95% Confidence Interval|Number
2565481|NCT02596230|Primary|Objective 2: Incidence Rate of ISTH (International Society on Thrombosis and Haemostasis) Major Bleeding and CRNMB (Clinically Relevant Non Major Bleeding) Per 100 Patient-years (Pt-yrs)|"Incidence rate of ISTH (International Society on Thrombosis and Haemostasis) major bleeding and CRNMB (clinically relevant non major bleeding) per 100 patient-years (1/(100*patient-years)). Each patient in the two treatment groups was weighted proportionally to the probability of that patient being assigned to the opposite treatment group, conditional on relevant observed baseline variables. The propensity scores were estimated using the multivariable logistic regression model.~For the restricted patient set, as a sensitivity analysis, the calculation of incidence rates and cumulative risks was performed without censoring at permanent discontinuation."|12 months following acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).|Restricted set: The restricted population was composed of all eligible patients, which lay within the region of propensity score overlap and who took the prescribed treatment at least once.|||events per 100 patient-years||95% Confidence Interval|Number
2565482|NCT02596230|Primary|Objective 1: Anticoagulant Treatment|"Type of treatment received following acute Venous Thromboembolism (VTE) event of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen.~The arm presented in this endpoint was separated into three arms in the participant flow tables (Not assigned to Dabigatran etexilate or Vitamin K antagonist,Dabigatran etexilate (1) and Vitamin K antagonist (1)) in order to distinguish patients participating in both objectives from patients only in objective 2."|Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).|All eligible patients with a DVT and/or PE (regardless of treatment) were enrolled for cross-sectional characterisation of the VTE patient population.|||Participants|||Count of Participants
2565506|NCT02595970|Secondary|saSPI (s, p and i) Over Time|"Self-administered Simplified Psoriasis Index (saSPI)~SPI for Simplified Psoriasis Index. SPI is composed of 3 domains :~s for the severity, min =0 and max=50~p for the psychosocial, min=0 and max=10~i for the intervention, min = 0 and max = 10 For each domain, high values represented a worse outcome The 3 subscales cannot be combined Please use sore on a scale for the unit of measure"|weeks 0, 16, 52|Full Analysis Set (observed)|||saSPI score||Standard Deviation|Mean
2565694|NCT02590588|Secondary|Organ Response|Number of patients with organ response using standard AL amyloidosis criteria.|3 months|Number of patients with organ response using standard AL amyloidosis criteria.||||||
2565483|NCT02596230|Primary|Objective 1: Index Event|"Type of index event (e.g., DVT or PE or DVT and PE) diagnosed at the time of acute Venous Thromboembolism (VTE) event of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen.~The arm presented in this endpoint was separated into three arms in the participant flow tables (Not assigned to Dabigatran etexilate or Vitamin K antagonist,Dabigatran etexilate (1) and Vitamin K antagonist (1)) in order to distinguish patients participating in both objectives from patients only in objective 2."|Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).|All eligible patients with a DVT and/or PE (regardless of treatment) were enrolled for cross-sectional characterisation of the VTE patient population.|||Participants|||Count of Participants
2565484|NCT02596230|Primary|Objective 1: Sex|"Sex of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen.~The arm presented in this endpoint was separated into three arms in the participant flow tables (Not assigned to Dabigatran etexilate or Vitamin K antagonist,Dabigatran etexilate (1) and Vitamin K antagonist (1)) in order to distinguish patients participating in both objectives from patients only in objective 2."|Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).|All eligible patients with a DVT and/or PE (regardless of treatment) were enrolled for cross-sectional characterisation of the VTE patient population.|||Participants|||Count of Participants
2565485|NCT02596230|Primary|Objective 1: Age|"Age in years of eligible patients collected for Objective 1 during baseline at the time of index event. Aim of Objective 1 was to characterize the Venous Thromboembolism (VTE) patient population including the initial acute event phase, i.e. all patients regardless of treatment. Patients who enrolled in Objective 1 and were treated with VKA or dabigatran were also eligible for Objective 2. The aim of objective 2 was to analyze the safety and effectiveness of dabigatran regimens in the treatment of DVT and PE over 1 year of follow-up in comparison to a VKA regimen.~The arm presented in this endpoint was separated into three arms in the participant flow tables (Not assigned to Dabigatran etexilate or Vitamin K antagonist,Dabigatran etexilate (1) and Vitamin K antagonist (1)) in order to distinguish patients participating in both objectives from patients only in objective 2."|Baseline collected within 14 days but not more than 6 months after diagnosis of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE).|All eligible patients with a DVT and/or PE (regardless of treatment) were enrolled for cross-sectional characterisation of the VTE patient population|||years||Standard Deviation|Mean
2565486|NCT02596035|Secondary|Total Duration of All Immune Modulating Medications Given for the Immune-Mediated Event|Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil.|Up to 100 days of the last dose of study drug (Approximately 2 years)|Analysis was performed in all treated participants who received any dose of nivolumab. Here, ‘number analyzed’ signifies those participants who were evaluable for specified categories.|||Weeks||Full Range|Median
2565487|NCT02596035|Secondary|Percentage of Participants Who Receive More Than Equal to (>=) 40 mg Prednisone Equivalents for the Immune-Mediated Event|Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil|Up to 100 days of the last dose of study drug (Approximately 2 years)|Analysis was performed in all treated participants who received any dose of nivolumab. Here, ‘number analyzed’ signifies those participants who were evaluable for specified categories.|||Percentage of participants|||Number
2565488|NCT02596035|Secondary|Percentage of Participants Who Receive Immune Modulating Medication for the Immune-Mediated Event (Any Grade)|Immune modulating medication includes corticosteroids, infliximab, cyclophosphamide, Intravenous immunoglobulin (IVIG), and mycophenolate mofetil|Up to 100 days of the last dose of study drug (Approximately 2 years)|Analysis was performed in all treated participants who received any dose of nivolumab. Here, ‘number analyzed’ signifies those participants who were evaluable for specified categories.|||Percentage of participants|||Number
2565489|NCT02596035|Secondary|Median Time to Resolution of High Grade (Grade 3-5) Immune Mediated Adverse Events|Time-to resolution of grade 3-5 AE was defined as the longest time from onset to complete resolution or improvement to the grade at baseline among all clustered select AEs in the category experienced by the participant. Events which worsened into grade 5 events (death) or have a resolution date equal to the date of death are considered unresolved. If a clustered AE is considered as unresolved, the resolution date will be censored to the last known date alive.|Up to 100 days of the last dose of study drug (Approximately 2 years)|Analysis was performed in all treated participants who received any dose of nivolumab. Here, ‘number analyzed’ signifies those participants who were evaluable for specified categories.|||Days||Full Range|Median
2565490|NCT02596035|Secondary|Median Time to Onset of High Grade (Grade 3-5) Immune Mediated Adverse Events|Time to onset was calculated from first dosing date to the event onset date. If a participant never experienced the given AE, the participant will be censored at the last contact date.|Up to 100 days of the last dose of study drug (Approximately 2 years)|Analysis was performed in all treated participants who received any dose of nivolumab. Here, ‘number analyzed’ signifies those participants who were evaluable for specified categories.|||Days||Full Range|Median
2565491|NCT02596035|Primary|Percentage of Participants Who Experienced High-Grade (Grade 3-4 and Grade 5) Immune Mediated Adverse Events (IMAEs)|IMAEs were tabulated using worst grade per Common Terminology Criteria for Adverse Events, National Cancer Institute (NCI CTCAE) Version 4.0 criteria by system organ class and MedDRA version 20.1 preferred term.|Up to 100 days of the last dose of study drug (Approximately 2 years)|Analysis was performed in all treated participants who received any dose of nivolumab.|||Percentage of participants|||Number
2565493|NCT02596009|Primary|Peak Inspiratory Flows Rates Summary by Inhalation Devices - FAS|"The peak inspiratory flows (PIF) rates obtained from the inhalation flow profiles generated by the COPD patients through the three dry powder inhalation (DPI) devices(Breezhaler®, Ellipta® and Handihaler®) were measured and compared (without drug or placebo administration). Each patient were required to generate inhalation flow profiles through all three DPI devices in a randomized cross-over sequence. The inspiratory measurements were taken in each of these devices in the same visit.~This FAS dataset includes PIF data from additional patients with corrected inhaler internal resistance values."|Visit 2 (Day 1)|Full Analysis Set (FAS): The FAS set consisted of all randomized patients who carried out inhalation maneuver through at least one inhaler.|||L/min||Standard Deviation|Mean
2565494|NCT02596009|Primary|Peak Inspiratory Flows Rates Summary by Inhalation Devices - PPS|The peak inspiratory flows (PIF) rates obtained from the inhalation flow profiles generated by the COPD patients through the three dry powder inhalation (DPI) devices(Breezhaler®, Ellipta® and Handihaler®) were measured and compared (without drug or placebo administration). Each patient were required to generate inhalation flow profiles through all three DPI devices in a randomized cross-over sequence. The inspiratory measurements were taken in each of these devices in the same visit.|Visit 2 (Day 1)|Per-protocol set (PPS): This PPS population consisted of all randomized patients, who completed inhalation flow maneuvers through all three inhaler devices.|||L/min||Standard Deviation|Mean
2565495|NCT02595983|Secondary|Number of Participants in Each Polyneuropathy Disability (PND) Stage Based on Worst Post-Baseline Score|PND Scores: Stage 0: No symptoms, Stage 1: Sensory disturbances but preserved walking capabilities, Stage 2: Impaired walking capacity, but ability to walk without a stick or crutches, Stage 3A/B: Walking with help of 1 or 2 sticks or crutches, Stage 4: confined to wheel chair. For each stage (0-4) at baseline, the number of participants is presented at their worst post-baseline score for each stage (0-4) post-baseline. Worst post-baseline is defined the highest PND classification for a participant recorded after the first dose of study drug.|Baseline, Months 6, 12, 18|Safety analysis set: All participants who received at least a single dose of study drug and for whom data were collected post-baseline. Data collection was limited due to the discontinuation of the drug treatment early in the study as per protocol amendment.|||Participants|||Count of Participants
2565496|NCT02595983|Secondary|Norfolk Quality of Life-Diabetic Neuropathy (QoL-DN) Questionnaire Score|The Norfolk QoL-DN questionnaire is a standardized 35-item patient-reported outcomes measure that is sensitive to the different features of diabetic neuropathy - small fiber, large fiber, and autonomic nerve function. The minimum and maximum values are -4 and 136, respectively. A higher score indicates a worse outcome.|Baseline, Months 6, 12, 18|Safety analysis set: All participants who received at least a single dose of study drug and for whom data were collected at each time point. Data collection was limited due to the discontinuation of the drug treatment early in the study as per protocol amendment.|||score on a scale||Standard Deviation|Mean
2565497|NCT02595983|Secondary|Change From Baseline in Modified Neurological Impairment Score (mNIS +7) Composite Score Over 18 Months|The mNIS+7 is a composite score that measures neurologic impairment which includes the following components: physical exam of lower limbs, upper limbs and cranial nerves to assess motor strength/weakness, electrophysiologic measurement of small and large nerve fiber function, sensory testing and postural blood pressure. The minimum and maximum values are 0 and 304, respectively. A higher score indicates a worse outcome. A negative change from baseline indicates an improvement.|Baseline, Months 6, 12, 18|Safety analysis set: All participants who received at least a single dose of study drug and for whom data were collected at each time point. Data collection was limited due to the discontinuation of the drug treatment early in the study as per protocol amendment.|||score on a scale||Standard Deviation|Mean
2565498|NCT02595983|Secondary|Percentage Change From Baseline in Serum TTR Over 18 Months|A negative percentage change from baseline indicates a reduction in serum TTR level.|Weeks 3, 7, 12, 18, 24, 26 (Month 6), 39 (Month 9), 52 (Month 12), 57, 78 (Month 18)|Safety analysis set: All participants who received at least a single dose of study drug and for whom data were collected at each time point. Data collection was limited due to the discontinuation of the drug treatment early in the study as per protocol amendment.|||percentage change from baseline in TTR||Standard Deviation|Mean
2565499|NCT02595983|Primary|Percentage Change From Baseline in Serum TTR at Month 6|A negative percentage change from baseline at Month 6 indicates a reduction in serum TTR level.|Month 6|Safety analysis set: All participants who received at least a single dose of study drug and for whom data were collected at Month 6.|||percentage change from baseline in TTR||Standard Deviation|Mean
2565500|NCT02595970|Primary|Changes of saSPI (s) at Week 16 Compared to Baseline|The primary efficacy objective of the study was to evaluate the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed. proSPI (s) score range is 0 to 50. Higher score means worse condition|Week 0 (baseline) to 16 weeks|Full Analysis Set (FAS): The FAS comprised all patients from the IS who were administered at least one dose of investigational drug with at least one Baseline and one post-baseline SPI evaluation.|||scores on a scale||Standard Deviation|Mean
2565501|NCT02595970|Secondary|Correlation Between proSPI (for Components p and i) and PASI|Correlation between proSPI (p, i) and PASI score by visit (Full Analysis Set (observed)) is summarized in table below|Over time (from Week 0 to Week 52)|Full Analysis Set (observed)|||Spearman correlation coefficient||95% Confidence Interval|Number
2565502|NCT02595970|Secondary|Correlation Between proSPI (for Each Component: s, p and i) and DLQI|Correlation between proSPI (for each component: s, p and i) and DLQI is summarized in table below|weeks 0, 16, 52|Full Analysis Set (observed)|||Spearman correlation coefficient||95% Confidence Interval|Number
2565503|NCT02595970|Secondary|Psoriasis Symptom Diary (PSD) Score|"assessment of pain, itching and scaling using the Psoriasis Symptom Diary questionnaire over time~PSD scores range from 0 to 10, with higher scores indicating a worse condition for each assessment: pain, itching and scaling"|weeks 0, 16, 52|Full Analysis Set (observed)|||scores on a scale||Standard Deviation|Mean
2565504|NCT02595970|Secondary|Self-administered PASI (SA-PASI)|self-administered PASI (SA-PASI) score|weeks 0, 16, 52|Full Analysis Set (observed)|||saPASI score (range: 0 to 72)||Standard Deviation|Mean
2565507|NCT02595970|Secondary|proSPI (s, p and i) Over Time|"Professional Version of Simplified Psoriasis Index (proSPI)~SPI for Simplified Psoriasis Index. SPI is composed of 3 domains :~s for the severity, min =0 and max=50~p for the psychosocial, min=0 and max=10~i for the intervention, min = 0 and max = 10 For each domain, high values represented a worse outcome The 3 subscales cannot be combined Please use sore on a scale for the unit of measure"|weeks 0, 16, 52|Full Analysis Set (observed)|||scores on a scale||Standard Deviation|Mean
2565508|NCT02595970|Secondary|Correlation Between PASI and proSPI (s)|Psoriasis Area Severity Index vs Professional Version of Simplified Psoraisis Index (proSPI) score|week 0, 16, 52|Full Analysis Set (observed)|||Spearman Correlation coefficient||95% Confidence Interval|Number
2565509|NCT02595970|Secondary|PASI (Psoriasis Area Severity Index) Score|PASI administered by a professional score range: 0 (no disease) to 72 (maximal disease)|week 0, 16, 52|Full Analysis Set (observed)|||scores on a scale||Standard Deviation|Mean
2565510|NCT02595970|Primary|proSPI (s) at Week 16 Compared to Baseline|The primary efficacy outcome of this study evaluates the benefit of secukinumab on the severity of psoriasis based on the SPI. This index comprises 3 components: severity (SPIs), psychosocial (SPIp) and intervention (SPIi) and were evaluated by both health care professional (professional, proSPI) and the patient (self-administered: saSPI). Only the severity components were evaluated for the primary objective: proSPI (s) and saSPI (s). Changes at Week 16 compared to Baseline in patients suffering from moderate to severe plaque psoriasis were analyzed for the purpose of this study.|Week 0 (baseline) to 16 weeks|The primary analysis was performed on the FAS. To assess for robustness of the results, the primary analysis was repeated for the FAS (on observed data).|||scores on a scale||Standard Deviation|Mean
2565511|NCT02595723|Primary|Rey Auditory Verbal Learning Test (RAVLT)|Rey Auditory Verbal Learning Test (RAVLT) is a test of verbal learning and declarative memory. During the test, 15 nouns that are read aloud for 5 consecutive trials. Each trial is followed by a free recall test (participant is asked to recall the words that were just read to them). The sum of correctly recalled words across 5 trials is called the total raw score. The raw scores on the total recall (number of words correct across trials 1-5) are converted to standardized T-scores (Mean=50; SD=10; range 20-100) based on participant age and gender. The scores below are presented as T-scores, with higher scores indicative of better performance.|4 days after intervention administration||||T-scores||Standard Deviation|Mean
2565512|NCT02595567|Primary|Feasibility of Using Indwelling Tunneled Pleural Catheters for the Management of Hepatic Hydrothorax|Feasibility of using ITPC's for the management of hepatic hydrothorax was assessed by the ability of patients to drain pleural effusions routinely via an indwelling tunneled pleural catheter for control of dyspnea related to pleural fluid accumulation. Feasibility was defined as successful catheter placement and improvement in shortness of breath following the procedure. Shortness of breath measurement was descriptive and self reported by patients on routine clinical follow up. Feasibility was also defined as patient ability to drain pleural effusions routinely at home. This was documented by patient logs documenting drainage.|From date of ITPC administration until the date of first documented complication such as infection that would require catheter removal or date of pleurodesis, whichever came first, assessed up to 12 months||||Participants|||Count of Participants
2565513|NCT02595502|Primary|Overall Comfort|Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 134+138+134=406 (Observations- 1 per subject per period, however 1 observation was not recorded) from period 1, 2 and 3 respectively. For the delefilcon A lens 138+134+138=410 from period 1, 2 and 3 respectively.|1 Week|The analysis population consists of subjects that completed the study without a major protocol deviation.|||units on a scale|Number of Observations|Standard Deviation|Mean
2565514|NCT02595450|Secondary|Overall Survival (OS) Time|Time from the start of study treatment to date of death due to any cause. Kaplan-Meier estimates were used for calculating OS.|Up to 6 years|As per the study design, no follow up data was collected and documentation ended with end of erlotinib therapy. Due to less events, median OS was not reached.|||months||Full Range|Median
2565515|NCT02595450|Primary|Percentage of Participants With Best Overall Response|Percentage of participants with best overall response of complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were reported. Per RECIST Version 1.1: CR was defined as complete disappearance of all target lesions and non-target disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No new lesions. PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. SD was defined as not qualifying for CR, PR, PD.|Up to 6 years|Analysis population included participants who received at least 2 documented treatment cycles. Missing data was not reported.|||percentage of participants|||Number
2565516|NCT02595450|Primary|Progression-free Survival (PFS) Time|Time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. Progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions, or unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for calculating PFS.|Up to 6 years|Analysis population included participants who received at least 2 documented treatment cycles.|||months||95% Confidence Interval|Median
2565517|NCT02595437|Other Pre-specified|Treatment-emergent Adverse Events (TEAEs)|The incidence of treatment-emergent AEs (TEAEs) and treatment-emergent serious AEs (TESAEs) will be grouped by body system. Adverse events were recorded from study Day 1 through the following up visit (approximately 1.5 weeks).|1.5 weeks|Safety Population: all patients who received any amount of study medication are included in the safety population.|||Participants|||Count of Participants
2565518|NCT02595437|Secondary|Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: AUC(0-end).|The PK will be done by assessing the mean absolute and baseline-corrected AUC(0-end) of total iron. The absolute AUC (0-end) includes the of iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.|0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours|Pharmacokinetic Group: all patients who received at least one dose of study drug and have sufficient PK samples (a sample at the end of infusion and at least 3 samples during the elimination phase)|||hours* micrograms/ deciliters||Geometric Coefficient of Variation|Geometric Mean
2565519|NCT02595437|Secondary|Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: AUC(Last).|The PK will be done by assessing the mean absolute and baseline-corrected AUC(last) of total iron. The absolute AUC (last) includes the iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.|0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours|Pharmacokinetic Group: all patients who received at least one dose of study drug and have sufficient PK samples (a sample at the end of infusion and at least 3 samples during the elimination phase)|||hours* micrograms/ deciliters||Geometric Coefficient of Variation|Geometric Mean
2565520|NCT02595437|Secondary|Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: Cmax.|The PK will be done by assessing the mean absolute and baseline-corrected Cmax of total iron. The absolute Cmax includes the concentration of iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.|0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours|Pharmacokinetic Group: all patients who received at least one dose of study drug and have sufficient PK samples (a sample at the end of infusion and at least 3 samples during the elimination phase)|||micrograms/ deciliters||Geometric Coefficient of Variation|Geometric Mean
2565521|NCT02595437|Primary|Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: AUC(0-end).|The PK will be done by assessing the mean absolute and baseline-corrected AUC(0-end) of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute AUC (0-end) includes iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected AUC (0-end) factors out the iron present in the serum prior to dosing and includes the administered iron only.|0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours|Pharmacokinetic Group: all patients who received at least one dose of study drug and have sufficient PK samples (a sample at the end of infusion and at least 3 samples during the elimination phase)|||hours* micrograms/ deciliters||Geometric Coefficient of Variation|Geometric Mean
2565522|NCT02595437|Primary|Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: AUC(Last).|The PK will be done by assessing the mean absolute and baseline-corrected AUC(last) of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute AUC(last) includes iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected AUC(last) factors out the iron present in the serum prior to dosing and includes the administered iron only.|0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours|Pharmacokinetic Group: all patients who received at least one dose of study drug and have sufficient PK samples (a sample at the end of infusion and at least 3 samples during the elimination phase)|||hours* micrograms/ deciliters||Geometric Coefficient of Variation|Geometric Mean
2565523|NCT02595437|Primary|Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: Cmax.|The PK will be done by assessing the mean absolute and baseline-corrected Cmax of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute Cmax includes the concentration of iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.|0, 1, 2, 4, 4.5, 5, 6, 8, 10 hrs|Pharmacokinetic Group: all patients who received at least one dose of study drug and have sufficient PK samples (a sample at the end of infusion and at least 3 samples during the elimination phase)|||microgram/deciliter||Geometric Coefficient of Variation|Geometric Mean
2565524|NCT02595073|Secondary|Change From Baseline in %BSA Affected at Day 28 ± 2|The change in %BSA Affected from Visit 1 Baseline (Day 1) to Visit 4 End of Treatment (Day 28 ± 2)|28 days||||percentage of BSA||Standard Error|Least Squares Mean
2565525|NCT02595073|Primary|The Number of Patients in Each Treatment Group That Have Clinical Success|Clinical Success defined using the following scores at Visit 4 (Day 28 ± 2): At least a 2-grade improvement from the baseline IGA score (i.e., clear [0] or almost clear [1]) AND A score of clear or mild (0 or 1) for both erythema and induration/papulation/edema|28 days||||Participants|||Count of Participants
2565526|NCT02595008|Primary|Number of Participants With HPA Axis Suppression|Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of ≤ 18 mcg/100ml.|28 days.||||Participants|||Count of Participants
2565527|NCT02594826|Secondary|Knowledge About Cervical Cancer|"Women's knowledge was assessed using 10 items. For each item, women responded whether the statement was true (Yes, No, or Don't know). Don't know responses were scored as incorrect. Each item that was answered correctly was scored as '1'. Correct responses were summed across all 10 items. Therefore, women's knowledge scores could range from 0 (no correct responses) to 10 (all correct responses), where higher scores represent greater knowledge."|12 months post-program|Preliminary data cleaning revealed that of the 705 participants who were included in the primary analysis, 29 participants had failed to answer 1/3 or more of the items on the questionnaire. Therefore, due to extensive missing data, these participants were excluded from the analysis of the secondary outcomes.|||units on a scale||Standard Error|Mean
2565528|NCT02594826|Primary|Number of Women Who Receive a Pap Smear Test|Number of women who receive a Pap smear test in each group|12 months||||participants|||Number
2565576|NCT02592876|Secondary|Objective Response Rate (ORR)|ORR is defined as the proportion of patients with complete remission (CR) or partial remission (PR) per independent review facility (IRF) at the end of treatment.|Up to 4 months|The modified Intent-to-Treat (mITT) analysis set includes all patients who were randomized to the recommended dose level of 19A+RICE or RICE and received at least 1 cycle of study treatment.|||Participants|||Count of Participants
2565529|NCT02594644|Secondary|Visual Analog Pain Scale|"The secondary will be any pain associated with the microneedle pretreatment and with the application of the PDT using the 100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity."|Immediately Post-Treatment||||Millimeters||Standard Error|Mean
2565530|NCT02594644|Primary|Difference in the Percentage of Complete Clearance of the Actinic Keratoses|The primary endpoint will be the difference in the percentage of complete clearance of the actinic keratoses as an intraindividual comparison between the treatment groups.|Baseline, 2 Months||||Percentage of AK Clearance||Standard Error|Mean
2565531|NCT02594163|Secondary|Number and Severity of Adverse Events (AEs)|All AEs are included in the summaries, unless treatment-emergent is specified.|Approximately 1 year|Safety population|||Participants|||Count of Participants
2565532|NCT02594163|Secondary|Overall Survival (OS)|OS is defined as the time randomization to death from any cause|Up to 1.5 years|Intent-to-treat analysis set|||months||Full Range|Median
2565533|NCT02594163|Secondary|Duration of Response (DOR)|DOR is defined as the time from first observation of response to disease progression/relapse, receipt of subsequent lymphoma chemotherapy other than the components of the study treatment regimen, or death from any cause, whichever occurs first.|Up to 10.5 months|Patients achieving a CR (including CMR) or PR (including PMR)|||months||Full Range|Median
2565534|NCT02594163|Secondary|Complete Remission (CR) Rate|CRR is the proportion of patients who achieve CR (including Complete Metabolic Response (CMR)) as best response to combination therapy on study.|Approximately 1 year||||Participants|||Count of Participants
2565535|NCT02594163|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from randomization to disease progression/relapse, receipt of subsequent lymphoma chemotherapy other than the components of the study treatment regimen, or death from any cause, whichever occurs first.|Up to 11.8 months||||months||Full Range|Median
2565536|NCT02594163|Primary|Objective Response Rate (ORR)|ORR is defined as the percentage of patients who achieve a Complete Response (CR) (including Complete Metabolic Response (CMR)) or Partial Response (PR) (including Partial Metabolic Response (PMR)) as best response to combination therapy on study|Approximately 1 year||||percentage of participants||95% Confidence Interval|Number
2565537|NCT02594098|Secondary|Fold-Change in A12 Level|Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of A12 as compared to baseline|at Week 16||||fold-change||Standard Error|Mean
2565538|NCT02594098|Secondary|Fold-Change in A9 Level|Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of A9 at Week 16 as compared to baseline.|at Week 16|data only for those who returned for week 16 visit|||fold-change||Standard Error|Mean
2565539|NCT02594098|Secondary|Fold-Change in A8 Level|Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of A8 at week 16 as compared to baseline|at Week 16|Data analysis only for those who returned for Week 16 visit|||fold-change||Standard Error|Mean
2565540|NCT02594098|Secondary|Fold-Change in S100A7 Level|Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of S100A7 at week 16 as compared to baseline.|at Week 16|Data analysis only for those who returned for Week 16 visit|||fold-change||Standard Error|Mean
2565541|NCT02594098|Secondary|Fold-Change in CXCL1 Level|Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of CXCL1 at week 16 as compared to baseline.|at Week 16|Data analysis only for those who returned for Week 16 visit|||fold-change||Standard Error|Mean
2565542|NCT02594098|Secondary|Fold-Change in CCL20 Level|Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of CCL20 at week 16 as compared to baseline.|at Week 16|Data analysis only for those who returned for Week 16 visit|||fold-change||Standard Error|Mean
2565543|NCT02594098|Secondary|Fold-Change in Elafin/Pi3 Level From Baseline|Change of IL-17 regulated keratinocyte products assessed by a change of the mRNA gene expression levels of elafin/Pi3 at week 16 as compared to baseline|at Week 16|Data analysis only for those who returned for Week 16 visit|||fold-change||Standard Error|Mean
2565544|NCT02594098|Secondary|Percentage Change From Baseline in EASI Scores|Percentage change in EASI scores at Week 16 as compared to baseline. Eczema Area and Severity Index (EASI) total score from 0-72, with higher score indicating more severity.|at Week 16|Data analysis only for those who returned for Week 16 visit|||percentage change||Standard Error|Mean
2565545|NCT02594098|Secondary|Percentage Change From Baseline in SCORAD Score|Percentage change in SCORAD scores at Week 16 as compared to baseline. SCORing Atopic Dermatitis (SCORAD) full score is 0-103, with higher score indicating more symptoms.|at Week 16|data for participants who returned for the week 16 visit|||percentage change||Standard Error|Mean
2565546|NCT02594098|Secondary|Number of Patients With Static Investigator's Global Assessment (IGA) Score 0 or 1|"The proportion of patients who achieve a score of clear-0 or almost clear-1 in the static IGA score at Week 16 as compared to Baseline. The static IGA score represents an overall static evaluation of dermatitis, performed by the investigator at each visit. It utilizes a scale of 6-points; total scale ranging from 0 (clear) to 5 (very severe disease)."|Week 16, Week 32, Week 52|data for participants who returned for the respective week visit|||Participants|||Count of Participants
2565547|NCT02594098|Secondary|Number of Patients Who Achieve EASI-50 Score|The proportion of patients who achieve an improvement of 50% or greater from their Baseline EASI score up to week 52. The EASI index assigns proportionate values to 4 body regions. Each region is assigned a score of 0 to 3, indicating none, mild, moderate, and severe clinical expression. The percentage of area involved is also assigned an eruption proportional score from 0 to 6. The total body score for each body region is obtained by multiplying the sum of the severity scores by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gives the EASI total from 0-72, with higher score indicating more severity.|Week 4, Week 16, Week 32, Week 52|data for participants who returned for the respective week visit|||Participants|||Count of Participants
2565695|NCT02590588|Secondary|Progression Free Survival|Evaluate time to progression|1 year|The evaluation of progression-free survival requires that a patient responds, and then progresses. There was only one patient enrolled and he did not remain on study long enough for his first 3 month response evaluation.||||||
2565548|NCT02594098|Secondary|Number of Patients With SCORAD-50|The proportion of patients who achieve an improvement of 50% or greater from their Baseline objective SCORAD up to week 52. SCORing Atopic Dermatitis (SCORAD) -The intensity part of the SCORAD index consists of six items: erythema, edema⁄papulation, excoriations, lichenification, oozing⁄crusts and dryness. Each item graded on a scale 0-3. The subjective items include daily pruritus and sleeplessness, graded on a 10-cm visual analogue scale, with maximum subjective score 20. SCORAD full score is 0-103, with higher score indicating more symptoms.|Week 4, Week 16, Week 32, Week 52|data for participants who returned for the respective week visit|||Participants|||Count of Participants
2565549|NCT02594098|Secondary|Fold-Change in K16 Expression of Lesional Skin|Epidermal hyperplasia assessed using change in the epidermal proliferation marker Ki67 at week 16 as compared to baseline. Staining quantification was performed with ImageJ 1.42|at Week 16||||fold-change||Standard Error|Mean
2565550|NCT02594098|Primary|Fold-Change in Epidermal Thickness of Lesional Skin|Epidermal hyperplasia assessed using change in epidermal thickness at week 16 as compared to baseline|at Week 16|Data only for those that returned for week 16 visit|||fold-change||Standard Error|Mean
2565551|NCT02593903|Primary|Number of Participants With Urinary Tract Infection|Urinary tract infection (UTI) will be diagnosed based on urine culture positive at 50,000CFUs per mL with one or both of the following: fever >38 Celsius, or significant fussiness and irritability with voiding per parent report. Asymptomatic bacteriuria is known and expected in this population; therefore culture positive results alone will not be sufficient to meet the definition of UTI.|4-8 days post-operation|Out of the consented and randomized participants these were the patients that we were able to obtain a post Op Urine sample|||Participants|||Count of Participants
2565552|NCT02593864|Primary|Change at 6 Months From Baseline in Serum COMP Biomarker Levels in Response to a Mechanical Stimulus (6 Month - Baseline)|Serum samples were collected before and after a 30 minute walking activity. Levels of serum cartilage oligomeric matrix protein (COMP) 3.5 hours following the 30-minute walk, expressed as a percentage of pre-activity resting values, were assessed, and values at 6 months were compared to baseline.|Baseline to 6 months|These analyses were based on available data from 15 subjects at both the baseline and follow-up visits for analysis of changes in COMP|||Percent of Resting||Standard Deviation|Mean
2565553|NCT02593864|Primary|Change at 6 Months From Baseline in First Peak Knee Adduction Moment (KAM): (6 Month Value - Baseline)|Knee adduction moment describes the medial/lateral load distribution of the knee measured while walking in a gait laboratory. Before normalization to account for size, the knee adduction moment is expressed in Nm. However, to account for different sized people, the knee adduction moment is transformed and expressed in percentage of body weight times height (%BW*ht). Higher knee adduction moments have been linked to more severe osteoarthritis (OA). Knee adduction moment will be analyzed at baseline and after 6 months of variable-stiffness shoe wear. Values at 6 months (in variable-stiffness shoe) will be compared to baseline (in control shoe).|Baseline to 6 months|These results were based on gait data for 18 subjects that was available at both the baseline and follow-up visits|||%Bw*Ht||Standard Deviation|Mean
2565554|NCT02593773|Secondary|Change From Baseline to Week 26 in Total Friedreich Ataxia Rating Scale Score (FARStot)|The FARS assessment includes neurological signs that specifically reflect neural substrates affected in FA. Based on a neurological examination, bulbar, upper limb, lower limb, peripheral nerve, and upright stability/gait functions are assessed. FARStot scores range from 0 (normal) to 125 (most impairment). A negative change from baseline indicates improvement.|From Baseline to Week 26 for all participants and from Baseline of HZNP-ACT-301 (NCT02415127)to Week 26 of HZNP-ACT-302 (52-week treatment duration) for participants receiving active treatment in both studies.|Because the Sponsor discontinued the development of ACTIMMUNE® for the treatment of Friedreich's Ataxia, the planned analyses of the efficacy endpoints were not conducted. Any raw data collected for this endpoint exist as by-subject listings only, and are unanalyzed per protocol.||||||
2565555|NCT02593773|Secondary|Number of FARS-mNeuro Responders and Non-Responders at Week 26|A participant was considered a responder if they had an improvement (decrease) of at least 3 points from Baseline at Week 26 for the FARS-mNeuro score. The FARS assessment includes neurological signs that specifically reflect neural substrates affected in FA. Based on a neurological examination, bulbar, upper limb, lower limb, peripheral nerve, and upright stability/gait functions were assessed. The FARS-mNeuro score excludes the peripheral nervous system subscale score and the facial and tongue atrophy and fasciculations from the bulbar subscale score. Scores range from 0 (normal) to 93 (most impairment).|Week 26|Because the Sponsor discontinued the development of ACTIMMUNE® for the treatment of Friedreich's Ataxia, the planned analyses of the efficacy endpoints were not conducted. Any raw data collected for this endpoint exist as by-subject listings only, and are unanalyzed per protocol.||||||
2565556|NCT02593773|Secondary|Change From Baseline at Week 26 in Timed 25-Foot Walk (T25FW)|The T25FW is a quantitative measure of lower extremity function. Participants are directed to 1 end of a clearly marked 25-foot course and instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the participant walk back the same distance, and the score for the test is the average of the 2 walks (after reciprocal transformation). Participants may use assistive devices when performing this task, with the same assistive device used at each assessment. A negative change from Baseline indicates improvement.|From Baseline to Week 26 for all participants and from Baseline of HZNP-ACT-301 (NCT02415127)to Week 26 of HZNP-ACT-302 (52-week treatment duration) for participants receiving active treatment in both studies.|Because the Sponsor discontinued the development of ACTIMMUNE® for the treatment of Friedreich's Ataxia, the planned analyses of the efficacy endpoints were not conducted. Any raw data collected for this endpoint exist as by-subject listings only, and are unanalyzed per protocol.||||||
2565577|NCT02592876|Secondary|Number of Participants With Laboratory Abnormalities|Number of participants who experienced a maximum post-baseline laboratory toxicity of Grade 3 or higher (per National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.03).|Up to 4 months|The safety analysis set includes all patients who received any amount of denintuzumab mafodotin or any component of RICE. Treatment group is determined using the actual treatment arm received, regardless of the randomization treatment assignment.|||Participants|||Count of Participants
2565696|NCT02590588|Primary|Overall Response|Evaluate hematologic response according to standard criteria|3 months|Number of participants with hematologic response is zero. There was only one patient enrolled and he did not remain on study long enough for his first 3 month response evaluation.||||||
2565557|NCT02593773|Secondary|Change From Baseline to Week 26 in Activities of Daily Living (ADL) Score|Participants and/or their caregivers rated 9 areas of daily living skills (speech, swallowing, cutting food and handling utensils, dressing, personal hygiene, falling, walking, quality of sitting position, and bladder function) on a 5-point scale (0=normal, 4=greatest loss of function) with allowable increments of 0.5 if the participant or caregiver strongly felt that a task falls between 2 scores. ADL scores can range from 0 (normal) to 36 (greatest loss of function). A negative change from baseline indicates improvement.|From Baseline to Week 26 for all participants and from Baseline of HZNP-ACT-301 (NCT02415127)to Week 26 of HZNP-ACT-302 (52-week treatment duration) for participants receiving active treatment in both studies.|Because the Sponsor discontinued the development of ACTIMMUNE® for the treatment of Friedreich's Ataxia, the planned analyses of the efficacy endpoints were not conducted. Any raw data collected for this endpoint exist as by-subject listings only, and are unanalyzed per protocol.||||||
2565558|NCT02593773|Primary|Change From Baseline to Week 26 in the Friedreich's Ataxia Rating Scale (FARS)-mNeuro Score|The FARS assessment includes neurological signs that specifically reflect neural substrates affected in FA. Based on a neurological examination, bulbar, upper limb, lower limb, peripheral nerve, and upright stability/gait functions were assessed. The FARS-mNeuro score excludes the peripheral nervous system subscale score and the facial and tongue atrophy and fasciculations from the bulbar subscale score. Scores range from 0 (normal) to 93 (most impairment). A negative change from baseline is an improvement.|From Baseline to Week 26 for all participants and from Baseline of HZNP-ACT-301 (NCT02415127)to Week 26 of HZNP-ACT-302 (52-week treatment duration) for participants receiving active treatment in both studies.|Because the Sponsor discontinued the development of ACTIMMUNE® for the treatment of Friedreich's Ataxia, the planned analyses of the efficacy endpoints were not conducted. Any raw data collected for this endpoint exist as by-subject listings only, and are unanalyzed per protocol.||||||
2565559|NCT02593773|Primary|Number of Participants With Positive/Negative Neutralizing Antibody (NAb) and Anti-Drug Antibody (ADA) Tests|NAb testing only for those participants with a positive ADA test. Baseline is defined as the last non-missing measurement/assessment on the date of Week 26 Visit from study HZNP-ACT-301 (NCT02415127). If this measurement was missing or otherwise unavailable, it was the last non-missing measurement/assessment on or prior to first dose in this study. If the participant discontinued the study, then premature withdrawal assessments were mapped to the nearest scheduled visit based on schedule of the assessment and the study day. If the mapped visit was already available then the visit was mapped to the next schedule visit. Last on study assessment is the last non-missing post-baseline assessment for each participant.|Baseline/Day 1 (Week 26 of Study HZNP-ACT-301 [NCT02415127]), Week 4, Week 13, Week 26, and Week 28 (follow-up safety visit)|Safety Population, defined as all participants who received at least 1 dose of open-label study drug after the Baseline Visit. Participants with an assessment at each time point are presented.|||participants|||Number
2565560|NCT02593773|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs|An adverse event (AE) is any untoward medical occurrence, whether or not the event is considered related to the investigational product. A TEAE is any adverse change from the subject's baseline condition, including any laboratory test value abnormality judged as clinically significant by the investigator, that occurs on or after the date of the first dose of study drug administered at home and throughout the duration of the clinical study, whether the adverse event is considered related to the treatment or not. An SAE is an AE that results in death, is life-threatening, results in persistent or significant disability or incapacity, inpatient hospitalization or prolongation of an existing hospitalization, is a congenital anomaly or birth defect, or other medically important event.|Baseline/Day 1 (Week 26 of Study HZNP-ACT-301 [NCT02415127]) through Week 28 (follow-up safety visit)|Safety Population, defined as all participants who received at least 1 dose of open-label study drug after the Baseline Visit.|||participants|||Number
2565561|NCT02593630|Secondary|Healed at 4 Weeks|Number of participants that are fully healed (epithelialized, no superficial ulcerations) at 4 weeks.|At the 4-week followup visit||||Participants|||Count of Participants
2565562|NCT02593630|Secondary|Intraoperative Pain|Intraoperative pain, measured on a standard 10 point pain scale (0=no pain, 5=moderate pain, 10 severe pain) using a pain face diagram.|Time of surgery, approximately 10-15 minutes||||units on a scale (0 - 10)||Inter-Quartile Range|Median
2565563|NCT02593630|Primary|Intraoperative Duration|Duration from placement of instrument to dressing|Intraoperative, 10-15 minutes||||minutes||Inter-Quartile Range|Median
2565564|NCT02593396|Secondary|Mean Difference of Malay Version of Sexual Desire Inventory 2 (SDI-2) Score at Weeks 6 Between Placebo and Active Groups|This scale contains 14 items which yield two domain scores: dyadic sexual desire (DSD) and solitary sexual desire (SSD). Items 1,2, 10, 14 are 8-point Likert scale from '0' (= not at all) to '7' (= more than once a day) concerning frequency of desire. Remaining Items are 9-point Likert scale from '0' (= 'no desire') to '8' (= 'strong desire'). DSD has 8 items and SSD has 3 items. The total sores for DSD range from 0 to 62, and SSD, range from 0 to 23. All items are summed up to dictate the total sexual desire (total score = 0 to 112). Higher scores reflect higher sexual desire.|Assessed at baseline, day 14(week 2), day 28(week four) and day 42 (week 6), data at day 42 (week 6) reported|Intention-to-treat (ITT) analyses were used for all efficacy variables and included all patients who had been randomized, took at least 1 dose of study trial medication and had at least one efficacy assessment after the baseline visit. There were four patients in each arm did not come for first efficacy assessment, Hence, excluded from analysis.|||score on a scale||Standard Deviation|Mean
2565578|NCT02592876|Secondary|Number of Participants With Adverse Events (AEs)|Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. AE severity and seriousness are assessed independently. 'Severity' characterizes the intensity of an AE and is graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. An AE is considered 'serious' if it is life-threatening, fatal, requires hospitalization, or is otherwise considered to be medically significant.|Up to 4 months|The safety analysis set includes all patients who received any amount of denintuzumab mafodotin or any component of RICE. Treatment group is determined using the actual treatment arm received, regardless of the randomization treatment assignment.|||Participants|||Count of Participants
2565565|NCT02593396|Secondary|Mean Difference of Malay Version of International Index of Erectile Function (Mal-IIEF-15) at Week 6 Between Placebo and Active Group|Mal-IIEF-15 is a 15-item, multi-dimensional self-reporting instrument for the evaluation of male sexual function for the past 4 weeks, consisted of five domains; 1) Erectile Function: sum of items 1, 2, 3, 4, 5 & 15. Total score range =1-30. 2) Orgasmic Function: sum of items 9 and 10. Total score range = 0 -10. 3) Sexual Desire: sum of items 11 and 12. Total score range = 2 -10. 4) Intercourse Satisfaction : sum of scores for Questions 6, 7 and 8. Total score range = 0 -15. 5) Overall Satisfaction: sum of items 13 and 14.Total score range = 2 -10. Items 1-10 is 6-point Likert-type scale from '0' (= No sexual activity) to '5' (= Almost always or always). Items 11-15 is 5-point Likert-type scale from '1' (= Almost never or never) to '5 '(= 'Almost always or always').The total Mal-IIEF-15 range from 5 (minimum) to 75 (Maximum). Higher score indicates better outcome in all domain.|assessed at baseline, day 14(week 2), day 28(week four) and day 42 (week 6), data at day 42 (week 6) reported|Intention-to-treat (ITT) analyses were used for all efficacy variables and included all patients who had been randomized, took at least 1 dose of study trial medication and had at least one efficacy assessment after the baseline visit. There were four patients in each arm did not come for first efficacy assessment, Hence, excluded from analysis.|||score on a scale||Standard Deviation|Mean
2565566|NCT02593396|Primary|Number of Participants With a Score of ≤2 (Much/Very Much Improved) on the Clinical Global Impression Scale Adapted for Sexual Function (CGI-SF) at Week 6 Between Placebo and Active Group|This scale assesses the changes of the sexual function. Scores range from 1 (normal/very much improved) to 7 (most extreme sexual dysfunction/very much worse). Lower scores indicate better sexual functioning.|assessed at baseline, day 14(week 2), day 28(week four) and day 42 (week 6), data at day 42 (week 6) reported|Intention-to-treat (ITT) analyses were used for all efficacy variables and included all patients who had been randomized, took at least 1 dose of study trial medication and had at least one efficacy assessment after the baseline visit. There were four patients in each arm did not come for first efficacy assessment, Hence, excluded from analysis.|||Participants|||Count of Participants
2565567|NCT02593305|Primary|Change in Systolic Blood Pressure During Metaboreflex Testing Following 4 Weeks of Dietary Nitrate Supplementation and Placebo in Older Adults.|Muscle metaboreflex examined by measuring systolic blood pressure responses to ischemic isometric muscle contraction in older adults before and after 4 weeks of beet root juice supplementation and placebo.|Pre and post 4 weeks dietary nitrate supplementation and pre and post 4 weeks of placebo.||||mmHg||Standard Error|Mean
2565568|NCT02593305|Primary|Change in Carotid Chemosensitivity Following 4 Weeks of Dietary Nitrate Supplementation and Placebo in Older Adults|Carotid chemosensitivity examined by measuring hypoxia ventilatory responsiveness in older adults before and after 4 weeks of beet root juice supplementation and placebo. Chemoreflex sensitivity was quantified as the change in ventilation in relation to the change in pulse oxygen saturation.|Pre and post 4 weeks dietary nitrate supplementation and pre and post 4 weeks of placebo.||||L/min/%SpO2||Standard Error|Mean
2565569|NCT02593149|Primary|Positive Blood Cultures (PBC's) Per 1,000 Central Venous Catheter (CVC)-Days|"This was calculated by dividing the cumulative number of PBCs by cumulative time at-risk as follows.~The National Healthcare Safety Network (NHSN) Center for Disease Control (CDC) 21-day outpatient hemodialysis patient rule is as follows: A PBC is considered a new event and counted only if it occurred 21 days or more after a previously reported PBC in the same patient; new PBC events are based on blood cultures drawn as an outpatient or within one calendar day after a hospital admission. Following a PBC additional same-type events were counted beginning 21 days following the initial event; the CVC-days were counted during this period. The CVC-days were calculated by summing the number of days each patient was at-risk of accruing a PBC. This analysis included all subjects that participated in the study that were not otherwise censored to more accurately count CVC-days."|Through the 13-month intervention period.||||PBCs per 1,000 CVC-days|||Number
2565570|NCT02592876|Secondary|Number of Patients Receiving Autologous Stem Cell Transplant (ASCT)|Number of patients receiving ASCT after completion of study treatment (EOT), prior to subsequent anticancer therapy.|Up to 30 months|The modified Intent-to-Treat (mITT) analysis set includes all patients who were randomized to the recommended dose level of 19A+RICE or RICE and received at least 1 cycle of study treatment.|||Participants|||Count of Participants
2565571|NCT02592876|Secondary|Number of Patients Achieving Peripheral Blood Stem Cell (PBSC) Mobilization|Defined as the number of patients who are able to adequately mobilize PBSC per investigator assessment on or after completion of study treatment, prior to subsequent anticancer therapy.|Up to 30 months|The modified Intent-to-Treat (mITT) analysis set includes all patients who were randomized to the recommended dose level of 19A+RICE or RICE and received at least 1 cycle of study treatment.|||Participants|||Count of Participants
2565572|NCT02592876|Secondary|Overall Survival (OS)|OS is defined as the time from date of randomization to date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the patient is known to be alive.|Up to 30 months|The modified Intent-to-Treat (mITT) analysis set includes all patients who were randomized to the recommended dose level of 19A+RICE or RICE and received at least 1 cycle of study treatment.|||months||Inter-Quartile Range|Median
2565573|NCT02592876|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from randomization to first documentation of disease progression per investigator, death due to any cause, or receipt of subsequent anticancer therapy, whichever comes first.|Up to 30 months|The modified Intent-to-Treat (mITT) analysis set includes all patients who were randomized to the recommended dose level of 19A+RICE or RICE and received at least 1 cycle of study treatment.|||months||Inter-Quartile Range|Median
2565574|NCT02592876|Secondary|Duration of Objective Response (OR)|Duration of OR is defined as the time from the start of the first radiographic documentation of OR per investigator to the first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy, whichever comes first.|Up to 27.9 months||||months||Inter-Quartile Range|Median
2565575|NCT02592876|Secondary|Duration of Complete Response (CR)|Defined as the time from the start of the first radiographic documentation of CR per investigator to the first documentation of progressive disease, death due to any cause, or receipt of subsequent anticancer therapy, whichever comes first.|Up to 27.9 months|The modified Intent-to-Treat (mITT) analysis set includes all patients who were randomized to the recommended dose level of 19A+RICE or RICE and received at least 1 cycle of study treatment.|||months||Inter-Quartile Range|Median
2565579|NCT02592876|Primary|Complete Remission Rate Per Independent Review Facility|Number of patients with complete metabolic response by PET (positive emission tomography) and CT (computed tomography) scans, or complete radiologic response by CT only.|Up to 4 months|The modified Intent-to-Treat (mITT) analysis set includes all patients who were randomized to the recommended dose level of 19A+RICE or RICE and received at least 1 cycle of study treatment.|||Participants|||Count of Participants
2565580|NCT02592655|Primary|Investigator Limb Occlusion Assessment|Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of each tourniquet intervention to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered a successful occlusion. This assessment was made by the investigator and ultrasonographer applying the intervention.|For 1 sustained minute after application of each tourniquet intervention.||||Participants|||Count of Participants
2565581|NCT02592655|Primary|Radiologist Limb Occlusion Assessment|"Duplex and color flow ultrasound are used to assess distal blood flow at the popliteal artery for 1 sustained minute following the application of a each tourniquet intervention to the middle upper thigh. If no flow is observed for 1 sustained minute then it is considered successful occlusion. A still image is then saved for later evaluation by the blinded outcome assessor.~The 5 cm tape was discontinued after the 4th participant because the tape was considered to unacceptably narrow after stretching and this was considered a mechanical failure even if occlusion was observed. Therefore the 5 cm tape data was not evaluated by the radiologist."|For 1 sustained minute after application of each tourniquet intervention.|"One ultrasound image from one of the participants of the pneumatic tourniquet (ATS) group failed to capture anatomy and was therefore not included in the analysis.~One ultrasound image from one of the participants of the windlass tourniquet (SOFTT-W) group failed to capture anatomy and was therefore not included in the analysis."|||Participants|||Count of Participants
2565582|NCT02592629|Primary|Change in Pain Assessment|Pain assessed on a visual analog scale from 1 (no pain) to 10 (worst pain imaginable). Pain score at 10 minutes post-injection is subtracted from baseline pre-injection score. Positive numbers to represent increases and negative numbers to represent decreases.|change from baseline assessment before injection at 10 minutes post injection||||units on a scale||Standard Deviation|Mean
2565583|NCT02592486|Secondary|The Number of Patients With Seroprotection Rate in Quadrivalent Influenza Vaccine.|Seroprotection rates (post-vaccination titer ≥1:40) were calculated to assess the immunogenicity of influenza vaccination.|4 to 6 weeks after vaccination (I1) and 24 weeks to 27 weeks after vaccination (I2)|Immunogenicity was assessed in patients who received the allocated intervention (i.e., received at least 1 dose of the study vaccine), and had a blood sample taken within the planned time period.|||Participants|||Count of Participants
2565584|NCT02592486|Secondary|The Geometric Mean Concentrations of Specific Antibodies to the 6 Serotypes (23F, 3, 4, 6B 14 and 19A)|Pneumococcal IgG concentrations were converted using natural log transformations and presented as a geometric mean concentration.|Before vaccination (at baseline; in designated P0), 4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)|Immunogenicity was assessed in patients who received the allocated intervention (i.e., received at least 1 dose of the study vaccine), and had a blood sample taken within the planned time period.|||micrograms per milliliter||95% Confidence Interval|Geometric Mean
2565585|NCT02592486|Secondary|The Number of Patients With Positive Antibody Response in Serotype 3, 4, 6B, 1 4 and 19A of Pneumococcal Antibody.|Positive antibody response was defined as ≥2-fold increase in IgG concentrations 4-6 weeks after PPSV23 vaccination in respective serotypes of the pneumococcal antibody.|4 to 6 weeks after vaccination (P1), 24 weeks to 27 weeks after vaccination (P2)|Immunogenicity was assessed in patients who received the allocated intervention (i.e., received at least 1 dose of the study vaccine), and had a blood sample taken within the planned time period.intervention (1 patient: fever, 2 patients: patient's decision|||Participants|||Count of Participants
2565586|NCT02592486|Primary|The Number of Patients With Positive Antibody Response in Serotype 23F of Pneumococcal Antibody.|The primary endpoint was the number of patients with positive antibody responses (≥2-fold increase in IgG concentrations 4-6 weeks after PPSV23 vaccination) in serotype 23F of the pneumococcal antibody.|1month after the dose of PPV23|"In the sequential group, 5 patients were excluded from primary analysis because of the reasons below.~1 patient: eligibility error, 1 patient: lost to follow-up (patient's decision), 3 patient: discontinued intervention (1 patient: fever, 2 patients: patient's decision"|||Participants|||Count of Participants
2565587|NCT02592447|Secondary|Self-reported Quality of Life (QoL) Scores - Change From Baseline Per Scoring Category|Baseline versus follow-up quality of life will be assessed with the Functional Assessment of Cancer Therapy General Scale (FACT-G) v.4, a 27-item measure yielding total score and scores for physical, social/family, emotional, and functional well-being of demonstrated reliability, validity, and sensitivity to change. FACT-G consists of 4 subscales: physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB) and social well-being (SWB). Scores on the four subscales are summed to produce a total score ranging from 0 to 108 with higher scores indicating better quality of life.|Baseline and at 18 weeks||||score on a scale||Standard Deviation|Mean
2565588|NCT02592447|Primary|Self-reported Fatigue Scores - Change From Baseline Per Scoring Category|Baseline versus follow-up fatigue will be assessed with the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue) v.4, a 13-item self-report measure yielding total score with demonstrated reliability, validity, sensitivity to change and an identified Minimally Clinically Important Difference (MID). The fatigue subscale consists of 13 items asking about fatigue in the past 7 days. Items are summed to produce a score ranging from 0-52 with lower scores indicating greater fatigue. A difference of 3 points on the fatigue subscale indicates a clinically-important difference.|Baseline and at 18 weeks||||score on a scale||Standard Deviation|Mean
2565589|NCT02592434|Secondary|Double Blind Phase: Number of Participants With Change From Baseline in Vital Sign Measures|Change in vital Signs included: Sitting diastolic blood pressure (mmHG): >=20mmHg IFB and >= 20mmHg DFB. Sitting systolic blood pressure mmHG: >= 30mmHg IFB and >= 30mmHg DFB. Supine diastolic blood pressure mmHG: >= 20mmHg IFB and >= 20mmHg DFB. Supine systolic blood pressure mmHG: >= 30mmHg IFB and >= 30mmHg DFB.|From the first dose of study drug in double blind up to week 44|The DBSAS consists of all participants who have received at least one dose of study medication in double-blind phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure and “n” signifies participants evaluable for this outcome measure at specified time points.|||Participants|||Count of Participants
2565590|NCT02592434|Secondary|Open-Label Phase: Number of Participants With Change From Baseline in Vital Sign Measures|Change in vital Signs included: Sitting diastolic blood pressure [mmHG]: >=20mmHg increase from baseline (IFB) and >= 20mmHg decrease from baseline (DFB). Sitting systolic blood pressure mmHG: >= 30mmHg IFB and >= 30mmHg DFB. Supine diastolic blood pressure mmHG: >= 20mmHg IFB and >= 20mmHg DFB. Supine systolic blood pressure mmHG: >= 30mmHg IFB and >= 30mmHg DFB.|From the first dose of study drug up to Week 18|OLFAS: all participants who were enrolled into OL phase of study and received at least one dose of study medication in open-label phase.Here, ‘n’ signifies participants evaluable for this outcome measure at specified time points.|||Participants|||Count of Participants
2565591|NCT02592434|Secondary|Double Blind Phase: Number of Participants With Vital Sign Abnormalities|Vital Sign Abnormalities criteria included: diastolic blood pressure (mmHG) of <50 mmHg, Pulse rate (BPM) of <40 bpm or >120 bpm, sitting diastolic blood pressure (mmHG) of <50 mmHg, sitting pulse rate beats per minute (bpm) of <40 bpm or >120 bpm, sitting systolic blood pressure (mmHG) of <90 mmHg, supine diastolic blood pressure (mmHG) of <50 mmHg, supine pulse rate (BPM) of <40 bpm or >120 bpm, supine systolic blood pressure (mmHG) of <90 mmHg, systolic blood pressure (mmHG) of <90 mmHg.|From the first dose of study drug in double blind up to week 44|The DBSAS consists of all participants who have received atleast one dose of study medication in double-blind phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure and “n” signifies participants evaluable for this outcome measure at specified time points.|||Participants|||Count of Participants
2565592|NCT02592434|Secondary|Open-Label Phase: Number of Participants With Vital Sign Abnormalities|Vital Sign Abnormalities criteria included: sitting diastolic blood pressure millimeters of Mercury (mmHG) of <50 mmHg, sitting pulse rate beats per minute (bpm) of <40 or 120 bpm, sitting systolic blood pressure (mmHG) of <90 mmHg, supine diastolic blood pressure (mmHG) of <50 mmHg, supine pulse rate (BPM) of <40 bpm or >120 bpm, supine systolic blood pressure (mmHG) of 90 mmHg.|From the first dose of study drug up to Week 18|The OLFAS consists of all participants who were enrolled into open-label phase of the study and received at least one dose of study medication in open-label phase. Here, ‘number analyzed’ signifies participants evaluable for this outcome measure at specified time points.|||Participants|||Count of Participants
2565593|NCT02592434|Secondary|Double Blind Phase: Number of Participants With Physical Examination Abnormalities|Physical examination included: abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, lymph nodes, neurological, nose, skin, and throat. Abnormality in physical examination was based on investigator's discretion.|Weeks 18, 20, 24, 28, 32, 36, 40 and 44|The DBSAS consists of all participants who have received at least one dose of study medication in double-blind phase. Here, ‘number analyzed’ signifies participants evaluable for this outcome measure at specified time points.|||Participants|||Count of Participants
2565594|NCT02592434|Secondary|Open-Label Phase: Number of Participants With Physical Examination Abnormalities|Physical examination included: abdomen, ears, extremities, eyes, general appearance, head, heart, lungs, lymph nodes, neurological, nose, skin, and throat. Abnormality in physical examination was based on investigator's discretion.|Baseline, Weeks 2, 4, 8, 12 and 18|The OLFAS consists of all participants who were enrolled into open-label phase of the study and received at least one dose of study medication in open-label phase. Here, ‘number analyzed’ signifies participants evaluable for this outcome measure at specified time points.|||Participants|||Count of Participants
2565595|NCT02592434|Secondary|Double Blind Phase: Number of Participants With Laboratory Abnormalities|Criteria: Hg, hematocrit Ery; <0.8* LLN, Ery. Mean Corpuscular Volume; <0.9*LLN, >1.1* ULN, Platelets; <0.5*LLN, >1.75*ULN, leu; <0.6*LLN, >1.5*ULN, Ly, Ly/leu, Neutrophils, Neutrophils/leu <0.8*LLN, Basophils/leu, Eosinophils, Eosinophils/leu, Monocytes, Monocytes/leu >1.2*ULN, Prothrombin Time >1.1*ULN, Ery Sedimentation Rate >1.5*ULN. Bilirubin, Direct Bilirubin, Indirect Bilirubin >1.5*ULN, AST, ALT, Gamma Glutamyl Transferase (GGT), Alkaline Phosphatase >3.0*ULN, Albumin >1.2*ULN, Creatinine >1.3*ULN, HDL Cholesterol (Chol)<0.8*LLN, LDL Chol, LDL Chol Friedewald Est PEG >1.2*ULN, Triglycerides >1.3*ULN, Calcium <0.9*LLN, Bicarbonate <0.9*LLN, Glucose >1.5*ULN, Creatine Kinase >2.0*ULN, C Reactive Protein >1.1*ULN, Chol >1.3*ULN. Urinalysis: Specific Gravity >1.030, pH >8, urine Glucose, Ketones, Protein, Hg, Nitrite, Leu Esterase >=1, Ery, Leu >=20, Hyaline Casts >1.Only those category in which at least 1 participant had data is reported.|From the first dose of study drug in double blind up to Week 44|The DBSAS consists of all participants who have received atleast one dose of study medication in double-blind phase.|||Participants|||Count of Participants
2565596|NCT02592434|Secondary|Open-Label Phase: Number of Participants With Laboratory Abnormalities|Criteria: Hemoglobin(Hg),hematocrit erythrocytes(Ery); <0.8*lower limit of normal (LLN), Ery. Mean Corpuscular Volume; <0.9*LLN, >1.1*upper limit of normal (ULN), Platelets; <0.5*LLN, >1.75*ULN, Leukocytes (leu); <0.6*LLN, >1.5*ULN, Lymphocytes (Ly), Ly/leu, Neutrophils, Neutrophils/leu <0.8*LLN, Basophils/leu, Eosinophils, Eosinophils/leu, Monocytes, Monocytes/leu >1.2*ULN, Ery Sedimentation Rate >1.5*ULN. Bilirubin, Indirect Bilirubin >1.5*ULN, AST, ALT, Gamma Glutamyl Transferase, Alkaline Phosphatase >3.0*ULN, Albumin >1.2*ULN, Creatinine >1.3*ULN, HDL Cholesterol (Chol)<0.8*LLN, LDL Chol, LDL Chol Friedewald Est PEG >1.2*ULN, Triglycerides >1.3*ULN, Calcium <0.9*LLN, Bicarbonate <0.9*LLN, Glucose >1.5*ULN, Creatine Kinase >2.0*ULN, C Reactive Protein >1.1*ULN, Chol >1.3*ULN. Urinalysis: Specific Gravity >1.030, Glucose, Ketones, Protein, Hg, Nitrite, Leu Esterase >=1, Ery, Leu >=20, Hyaline Casts >1.Only those category in which at least 1 participant had data is reported.|From the first dose of study drug up to Week 18|The OLFAS consists of all participants who were enrolled into open-label phase of the study and received at least one dose of study medication in open-label phase. Here, ‘number analyzed’ signifies participants evaluable for this outcome measure at specified time points.|||Participants|||Count of Participants
2565597|NCT02592434|Secondary|Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Genitalia)|Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: Testicular volume < 4 ml or long axis < 2.5 cm, Stage 2: 4 ml-8 ml (or 2.5-3.3 cm long), 1st pubertal sign in males, Stage 3: 9 ml-12 ml (or 3.4-4.0 cm long), Stage 4: 15-20 ml (or 4.1-4.5 cm long), Stage 5: > 20 ml (or > 4.5 cm long). Tanner Stage for genitalia at Week 44 was summarized and reported using number of participants in each stage.|Week 44|The DBSAS consists of all participants who have received atleast one dose of study medication in double-blind phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2565598|NCT02592434|Secondary|Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Genitalia)|Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: Testicular volume < 4 ml or long axis < 2.5 cm, Stage 2: 4 ml-8 ml (or 2.5-3.3 cm long), 1st pubertal sign in males, Stage 3: 9 ml-12 ml (or 3.4-4.0 cm long), Stage 4: 15-20 ml (or 4.1-4.5 cm long), Stage 5: > 20 ml (or > 4.5 cm long). Tanner Stage for genitalia at Day 1 was summarized and reported using number of participants in each stage.|Day 1|The OLFAS consists of all participants who were enrolled into open-label phase of the study and received at least one dose of study medication in open-label phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2565599|NCT02592434|Secondary|Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Breast Exam)|"Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: No glandular breast tissue palpable, Stage 2: Breast bud palpable under areola (1st pubertal sign in females), Stage 3: Breast tissue palpable outside areola; no areolar development, Stage 4: Areola elevated above contour of the breast, forming double scoop appearance, Stage 5: Areolar mound recedes back into single breast contour with areolar hyperpigmentation, papillae development and nipple protrusion. Tanner Stage for Breast at Week 44 was summarized and reported using number of participants in each stage."|Week 44|The DBSAS consists of all participants who have received at least one dose of study medication in double-blind phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2565600|NCT02592434|Secondary|Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Breast Exam)|"Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: No glandular breast tissue palpable, Stage 2: Breast bud palpable under areola (1st pubertal sign in females), Stage 3: Breast tissue palpable outside areola; no areolar development, Stage 4: Areola elevated above contour of the breast, forming double scoop appearance, Stage 5: Areolar mound recedes back into single breast contour with areolar hyperpigmentation, papillae development and nipple protrusion. Tanner Stage for Breast at Day 1 was summarized and reported using number of participants in each stage."|Day 1|The OLFAS consists of all participants who were enrolled into open-label phase of the study and received at least one dose of study medication in open-label phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2565601|NCT02592434|Secondary|Double Blind Phase: Number of Participants With Tanner Staging Evaluation (Pubic Hair)|Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males) were assessed in this study and with values in the scale ranging from: Stage 1: no hair, Stage 2: downy hair, Stage 3: Scant terminal hair, Stage 4: Terminal hair that fills the entire triangle overlying the pubic region and Stage 5: Terminal hair that extends beyond the inguinal crease onto the thigh. Tanner Stage for pubic hair at Week 44 was summarized and reported using number of participants in each stage.|Week 44|The double-blind safety analysis set (DBSAS) consists of all participants who have received at least one dose of study medication in double-blind phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2565602|NCT02592434|Secondary|Open-Label Phase: Number of Participants With Tanner Staging Evaluation (Pubic Hair)|Tanner stage is a scale used to document the stage of development of puberty by assessing the secondary sexual characteristics: Pubic hair (both male and female), breast size (for females); and size of the genitalia (for males).were assessed in this study and with values in the scale ranging from: Stage 1: no hair, Stage 2: downy hair, Stage 3: Scant terminal hair, Stage 4: Terminal hair that fills the entire triangle overlying the pubic region and Stage 5: Terminal hair that extends beyond the inguinal crease onto the thigh. Tanner Stage for pubic hair at Day 1 was summarized and reported using number of participants in each stage.|Day 1|The OLFAS consists of all participants who were enrolled into open-label phase of the study and received at least one dose of study medication in open-label phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2565603|NCT02592434|Secondary|Double Blind Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases|Serious infection defined as any infection that requires hospitalization for treatment or requires parenteral antimicrobial therapy or meets other criteria that require it to be classified as a serious adverse event. Cytopenia was categorized as: lymphocyte counts <500 lymphocytes/mm^3, neutrophil counts <1000 neutrophils/mm^3, platelet counts <100000 platelets/mm^3, any single hemoglobin (hg) value <8 g/dL and any single hemoglobin value drops >=2 g/dL below baseline. Number of Participants With serious infections, cytopenia, malignancies and Cardiovascular Diseases are reported.|From the first dose of study drug in double blind up to week 44|The DBFAS consists of all participants randomized to double-blind phase who received at least one dose of study medication in double-blind phase.|||Participants|||Count of Participants
2565604|NCT02592434|Secondary|Open-Label Phase: Number of Participants With Serious Infections, Cytopenia, Malignancies and Cardiovascular Diseases|Serious infection defined as any infection that requires hospitalization for treatment or requires parenteral antimicrobial therapy or meets other criteria that require it to be classified as a serious adverse event. Cytopenia was categorized as: lymphocyte counts: <500 lymphocytes/ millimeter^3 (mm), neutrophil counts <1000 neutrophils/mm^3, platelet counts <100,000 platelets/mm^3, any single hemoglobin value <8 grams/decilitre (g/dL) and any single hemoglobin value drops >=2 g/dL below baseline. Number of Participants With serious infections, cytopenia, malignancies and Cardiovascular Diseases are reported.|From the first dose of study drug up to Week 18|The OLFAS consists of all participants who were enrolled into open-label phase of the study and received at least one dose of study medication in open-label phase.|||Participants|||Count of Participants
2565605|NCT02592434|Secondary|Open-Label Phase: Taste Assessment of Tofacitinib Oral Solution on Day 14|Oral solution was given only to participants weighing <40 kg and to the participants who were unable to swallow tablets. Taste assessment was evaluated using a 5 categories questionnaire. Participants were asked to answer in one of the following categories to describe the taste of oral solution of tofacitinib: dislike very much, dislike a little, not sure, like a little and like very much. Number of participants within each category are reported.|Day 14|The OLFAS consists of all participants who were enrolled into open-label phase of the study and received at least one dose of study medication in open-label phase. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2565606|NCT02592434|Secondary|Double Blind Phase:Change From Double-Blind Baseline in Physician's Global Assessment (PGA) of Psoriasis Assessments at Weeks 20, 24, 28, 32, 36, 40 and 44|The PGA of psoriasis was scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 5 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and ranged as 0= no symptom to 5=severe, higher score indicates more severity.|Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44|DBPsA included all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase with PsA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||score on scale||Standard Deviation|Mean
2565607|NCT02592434|Secondary|Open-Label Phase: Changes From Baseline in Physician's Global Assessment (PGA) of Psoriasis Assessments at Weeks 2, 4, 8, 12 and 18|The PGA of psoriasis was scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 5 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and ranged as 0= no symptom to 5=severe, higher score indicates more severity.|Baseline, Weeks 2, 4, 8, 12 and 18|OLPsA included all participants who were enrolled into the open-label phase of study and received at least 1 dose of study medication in the open-label phase with PsA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||score on scale||Standard Deviation|Mean
2565608|NCT02592434|Secondary|Double Blind Phase: Changes From Double Blind Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 20, 24, 28, 32, 36, 40 and 44|Percentage of body surface area affected by psoriasis was estimated using the palm method. One of the participant's palm to PIP and thumb together represented 1% of total BSA. Regions of the body were assigned specific number of palms with percentage (Head and Neck = 10% [10 palms], Upper extremities = 20% [20 palms], Trunk [axillae and groin] = 30% [30 palms], Lower extremities [buttocks] = 40% [40 palms]). The number of palms of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44|DBPsA included all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase with PsA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||percentage of BSA||Standard Deviation|Mean
2565609|NCT02592434|Secondary|Open-Label Phase: Changes From Baseline in Percentage of Body Surface Area (BSA) Affected With Psoriasis at Weeks 2, 4, 8, 12 and 18|Percentage of body surface area affected by psoriasis was estimated using the palm method. One of the participant's palm to proximal interphalangeal (PIP) and thumb =\together represented 1% of total BSA. Regions of the body were assigned specific number of palms with percentage (Head and Neck = 10% [10 palms], Upper extremities = 20% [20 palms], Trunk [axillae and groin] = 30% [30 palms], Lower extremities [buttocks] = 40% [40 palms]). The number of palms of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline, Weeks 2, 4, 8, 12 and 18|OLPsA (OL psoriatic arthritis PsA) included all participants who were enrolled into the open-label phase of study and received at least 1 dose of study medication in the open-label phase with PsA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||percentage of BSA||Standard Deviation|Mean
2565610|NCT02592434|Secondary|Double Blind Phase: Change From Double-Blind Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 20, 24, 28, 32, 36, 40 and 44|Participants with ERA undergo Overall Back Pain and Nocturnal Back Pain assessment. For Overall Back Pain, parent/legal guardian/participant were asked to provide a response to the question: What is the amount of back pain at any time that your child experienced in the past week? And For Nocturnal Back Pain: What is the amount of back pain at night that your child experienced in the past week?. Response to these questions was provided by parent/legal guardian/participant using a VAS of 0-10, where 0= No Pain and 10= Most Severe Pain, higher score indicated more severe pain.|Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44|DBERA included all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase with ERA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||score on scale||Standard Deviation|Mean
2565611|NCT02592434|Secondary|Open-Label Phase: Change From Baseline in the Overall Back Pain and Nocturnal Back Pain Responses at Week 2, 4, 8, 12 and 18|Participants with ERA undergo Overall Back Pain and Nocturnal Back Pain assessment. For Overall Back Pain, parent/legal guardian/participant were asked to provide a response to the question: What is the amount of back pain at any time that your child experienced in the past week? And For Nocturnal Back Pain: What is the amount of back pain at night that your child experienced in the past week?. Response to these questions was provided by parent/legal guardian/participant using a VAS of 0-10, where 0= No Pain and 10= Most Severe Pain, higher score indicated more severe pain.|Baseline, Weeks 2, 4, 8, 12 and 18|OLERA included all participants who were enrolled into the open-label phase of study and received at least 1 dose of study medication in the open-label phase with ERA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||score on scale||Standard Deviation|Mean
2566439|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (µmol/L)||Baseline, Week 24|Participants with measurements at given time point.|||µmol/L||Standard Deviation|Mean
2565612|NCT02592434|Secondary|Double Blind Phase: Change From Double Blind Baseline in the Modified Schober's Test at Week 20, 24, 28, 32, 36, 40 and 44|Participants with ERA undergo Modified Schober's Test. In the Modified Schober's Test, a mark was placed 5 cm below the midpoint of a line that joined the posterior superior iliac spines. Another mark was placed 10 cm above the first. The participant then bent maximally forward with the knees fully extended. The distance between the two marks was then re-measured. The full measurement between the two lines was recorded to the nearest tenth of a centimeter and is reported.|Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44|DBERA included all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase with ERA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||cm||Standard Deviation|Mean
2565613|NCT02592434|Secondary|Open-Label Phase: Change From Baseline in the Modified Schober's Test at Week 2, 4, 8, 12 and 18|Participants with ERA undergo Modified Schober's Test. In the Modified Schober's Test, a mark was placed 5 cm below the midpoint of a line that joined the posterior superior iliac spines. Another mark was placed 10 cm above the first. The participant then bent maximally forward with the knees fully extended. The distance between the two marks was then re-measured. The full measurement between the two lines was recorded to the nearest tenth of a centimeter and is reported.|Baseline, Weeks 2, 4, 8, 12 and 18|OLERA included all participants who were enrolled into the open-label phase of study and received at least 1 dose of study medication in the open-label phase with ERA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||centimeter (cm)||Standard Deviation|Mean
2565614|NCT02592434|Secondary|Double Blind Phase: Change From Double-Blind Baseline in the Tender Entheseal Assessment at Weeks 20, 24, 28, 32, 36, 40 and 44|Participants with ERA undergo Tender entheseal assessment. Tender entheseal assessment: Entheses were assessed and coded as: 1= any tenderness, 0= no tenderness, NE= not evaluable. Total number of tender entheses: 66*(total number of tender entheses with counts > 0)/number of non-missing tender entheses. If > 33 tender entheseal counts were missing, total number of tender entheses was defined as missing.|Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44|DBERA included all participants randomized to the DB phase who received at least 1 dose of study medication in the DB phase with ERA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||tender entheses score||Standard Deviation|Mean
2565615|NCT02592434|Secondary|Open-Label Phase: Change From Baseline in the Tender Entheseal Assessment at Weeks 2, 4, 8, 12 and 18|Participants with enthesitis-related arthritis (ERA) undergo Tender entheseal assessment. Tender entheseal assessment: Entheses were assessed and coded as: 1= any tenderness, 0= no tenderness, NE= not evaluable. Total number of tender entheses: 66*(total number of tender entheses with counts > 0)/number of non-missing tender entheses. If > 33 tender entheseal counts were missing, total number of tender entheses was defined as missing.|Baseline, weeks 2, 4, 8, 12 and 18|OLERA included all participants who were enrolled into the open-label phase of study and received at least 1 dose of study medication in the open-label phase with ERA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||tender entheses score||Standard Deviation|Mean
2565616|NCT02592434|Secondary|Double Blind Phase: Percentage of Participants With Active Uveitis at Week 24 and Week 44|"Uveitis is the inflammation of the uvea. Participants were assessed for presence of uveitis (according to Standard Uveitis Nomenclature [SUN]). If Uveitis was present in participant at Baseline, it was considered as active uveitis; If Uveitis was not present in participant at Baseline, it was considered as Inactive uveitis. As per SUN, Uveitis is defined as: anterior (in which anterior chamber is primary site of inflammation); intermediate (primary site of inflammation: vitreous); posterior (primary site of inflammation: retina or choroid). Percentage of participants with active uveitis (of any type) are reported."|Week 24 and Week 44|The double-blind safety analysis set (DBSAS) consists of all participants who have received at least one dose of study medication in double-blind phase.|||percentage of participants|||Number
2565617|NCT02592434|Secondary|Open-Label Phase: Percentage of Participants With Active Uveitis at Baseline|"Uveitis is the inflammation of the uvea. Participants were assessed for presence of uveitis (according to Standard Uveitis Nomenclature [SUN]). If Uveitis was present in participant at Baseline, it was considered as active uveitis; If Uveitis was not present in participant at Baseline, it was considered as Inactive uveitis. As per SUN, Uveitis is defined as: anterior (in which anterior chamber is primary site of inflammation); intermediate (primary site of inflammation: vitreous); posterior (primary site of inflammation: retina or choroid). Percentage of participants with active uveitis (of any type) are reported."|Baseline|The OLFAS consists of all participants who were enrolled into open-label phase of the study and received at least one dose of study medication in open-label phase.|||percentage of participants|||Number
2565618|NCT02592434|Secondary|Double Blind Phase:Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire (CHAQ)- Discomfort Index at Weeks 20, 24, 28, 32, 36, 40 and 44|CHAQ is a validated instrument and comprises of two indices, Disability and Discomfort, and global assessment of arthritis (overall well-being). Discomfort Index included: assessment of discomfort, the parent/legal guardian/participant were asked to provide a response to the question: How much pain do you think your child had because of his or her illness in the past week?, The parent/legal guardian/ participant rated the overall pain on a 0 to 10 VAS, where '0' indicates 'No Pain' and '10' indicates 'Very Severe Pain', higher scores indicates more severity.|Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36,40 and 44|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||score on scale||Standard Deviation|Mean
2565625|NCT02592434|Secondary|Open Label Phase: JIA ACR Core Variable- Change From Baseline in Parent/Legal Guardian/Participant Global Evaluation of Overall Well-Being at Weeks 2, 4, 8, 12 and 18|The parent/or legal guardian/participant rated the overall well-being on a 21-numbered circle VAS ranges from 0 to 10 (in 0.5 increments), with '0' as 'Very Well' and '10' as 'Very Poorly', higher scores=more disease activity.|Baseline, Weeks 2, 4, 8, 12 and 18|The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||score on scale||Standard Deviation|Mean
2565619|NCT02592434|Secondary|Open Label Phase: Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ)- Discomfort Index at Weeks 2, 4, 8, 12 and 18|CHAQ is a validated instrument and comprises of two indices, Disability and Discomfort, and global assessment of arthritis (overall well-being). Discomfort Index included: assessment of discomfort, the parent/legal guardian/participant were asked to provide a response to the question: How much pain do you think your child had because of his or her illness in the past week?, The parent/legal guardian/ participant rated the overall pain on a 0 to 10 VAS, where '0' indicates 'No Pain' and '10' indicates 'Very Severe Pain', higher scores indicates more severity.|Baseline, Weeks 2, 4, 8, 12 and 18|The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||score on scale||Standard Deviation|Mean
2565620|NCT02592434|Secondary|Double Blind Phase: Change From Double-Blind Baseline in Child Health Questionnaire (CHQ) Responses at Week 44|CHQ: 50-item, 14 subscale (Global health, physical functioning, social limitations: emotional, social limitations: physical, bodily pain, behavior, global behavior, mental health, self-esteem, general health, Change in health, emotional impact on parent, time impact on parent, family activities, family cohesion) parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents. Each subscale rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Two summary scores: Physical Health and Psychosocial Health were weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.|Double-Blind Baseline (Week 18), Week 44|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||score on a scale||Standard Error|Least Squares Mean
2565621|NCT02592434|Secondary|Open-Label Phase: Change From Baseline in Child Health Questionnaire (CHQ) Responses at Week 4 and Week 18|CHQ: 50-item, 14 subscale (Global health, physical functioning, social limitations: emotional, social limitations: physical, bodily pain, behavior, global behavior, mental health, self-esteem, general health, Change in health, emotional impact on parent, time impact on parent, family activities, family cohesion) parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents. Each subscale rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Two summary scores: Physical Health and Psychosocial Health were weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.|Baseline, Week 4 and Week 18|The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||score on scale||Standard Deviation|Mean
2565622|NCT02592434|Secondary|Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Scores at Weeks 20, 24, 28, 32, 36, and 40|CHAQ: valid assessment of functional disability, discomfort in participants with rheumatic diseases. It comprises of three indices: Disability and Discomfort, and global assessment of arthritis (overall well-being). CHAQ-DI: as a measure of functional ability, consists of 30 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed, among a total of 30 items. Each question was rated on a 4-point scale of difficulty in performance ranges from 0 (no difficulty) to 3 (unable to do). To calculate overall score, participant must have a domain score in at least 6 of the 8 domains. Scores of 8 domains were averaged to calculate the CHAQ-DI total score which ranges from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction), higher score indicates more disability. Change from double-blind baseline at Weeks 20, 24, 28, 32, 36, and 40 in DI total score is reported.|Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, and 40|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||score on scale||Standard Deviation|Least Squares Mean
2565623|NCT02592434|Secondary|Open Label Phase: JIA ACR Core Variable- Change From Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Scores at Weeks 2, 4, 8, 12 and 18|CHAQ is a valid assessment of functional disability, discomfort in participants with rheumatic diseases. It comprises of three indices: Disability and Discomfort, and global assessment of arthritis (overall well-being). CHAQ-DI: as a measure of functional ability, consists of 30 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed, among a total of 30 items. Each question was rated on a 4-point scale of difficulty in performance ranges from 0 (no difficulty) to 3 (unable to do). To calculate the overall score, the participant must have a domain score in at least 6 of the 8 domains. Scores of 8 domains were averaged to calculate the CHAQ-DI total score which ranges from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction), higher score indicates more disability. Change from baseline at Weeks 2, 4, 8, 12 and 18 in DI total score is reported.|Baseline, Weeks 2, 4, 8, 12 and 18|The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||score on scale||Standard Deviation|Mean
2565624|NCT02592434|Secondary|Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Parent/Legal Guardian/Participant Global Evaluation of Overall Well-Being at Weeks 20, 24, 28, 32, 36, 40 and 44|The parent/or legal guardian/participant rated the overall well-being on a 21-numbered circle VAS ranges from 0 to 10 (in 0.5 increments), with '0' as 'Very Well' and '10' as 'Very Poorly', higher scores=more disease activity.|Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||score on scale||Standard Error|Least Squares Mean
2565626|NCT02592434|Secondary|Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Physician Global Evaluation of Disease Activity at Weeks 20, 24, 28, 32, 36, 40 and 44|Physician global evaluation of disease activity was measured on a 21-numbered circle VAS ranges from 0 to 10 (in 0.5 increments), with '0' as 'No Activity' and '10' as 'Maximum Activity', higher score indicated more disease activity.|Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||score on scale||Standard Error|Least Squares Mean
2565627|NCT02592434|Secondary|Open Label Phase: JIA ACR Core Variable- Change From Baseline in Physician Global Evaluation of Disease Activity at Week 2, 4, 8, 12 and 18|Physician global evaluation of disease activity was measured on a 21-numbered circle VAS ranges from 0 to 10 (in 0.5 increments), with '0' as 'No Activity' and '10' as 'Maximum Activity', higher score indicated more disease activity.|Baseline, Weeks 2, 4, 8, 12 and 18|The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||score on scale||Standard Deviation|Mean
2565628|NCT02592434|Secondary|Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Number of Joints With Limited Range of Motion at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44|The maximum number of joints with limitation of movement was 67 and these were defined as those in the joint assessment with 'limitation of motion'.|Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||joints with limited range of motion||Standard Error|Least Squares Mean
2565629|NCT02592434|Secondary|Open Label Phase: JIA ACR Core Variable- Change From Baseline in Number of Joints With Limited Range of Motion at Weeks 2, 4, 8, 12 and 18|The maximum number of joints with limitation of movement was 67 and these were defined as those in the joint assessment with 'limitation of motion'.|Baseline, Weeks 2, 4, 8, 12 and 18|The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||joints with limited range of motion||Standard Deviation|Mean
2565630|NCT02592434|Secondary|Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Number of Joints With Active Arthritis at Weeks 20, 24, 28, 32, 36, 40 and 44|Number of joints with active arthritis defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness. Number of joints ranged from 0 to 71.|Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||joints with active arthritis||Standard Error|Least Squares Mean
2565631|NCT02592434|Secondary|Open Label Phase: JIA ACR Core Variable- Change From Baseline in Number of Joints With Active Arthritis at Week 2, 4, 8, 12 and 18|Number of joints with active arthritis defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness. The score range of the number of joints is from 0-71.|Baseline, Weeks 2, 4, 8, 12 and 18|The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||joints with active arthritis||Standard Deviation|Mean
2565632|NCT02592434|Secondary|Double Blind Phase: Percentage of Participants With Presence of JIA ACR Clinical Remission|"JIA ACR Clinical Remission Criteria included: Clinical inactive disease for 6 months continuously while on medications for JIA. Clinical Inactive Disease criteria included: No joints with active arthritis, No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to sJIA, No active uveitis (as defined by the SUN Working Group), Normal ESR (within normal limits of the method used where tested) or, if elevated, not attributable to JIA, Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]) score of 'best possible' (score of 0) on the scale used, morning stiffness of less than or equal to (<=) 15 minutes."|From Week 18 in double blind phase up to Week 44|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.|||percentage of participants|||Number
2565633|NCT02592434|Secondary|Double Blind Phase: Percentage of Participants With JIA ACR Inactive Disease at Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44|"JIA ACR Inactive Disease criteria included: No joints with active arthritis, No fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to sJIA, No active uveitis (as defined by the Standardized Uveitis Nomenclature (SUN) Working Group), Normal ESR (within normal limits of the method used where tested) or, if elevated, not attributable to JIA, Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]) score of 'best possible' (score of 0) on the scale used, morning stiffness of <=15 minutes."|Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||percentage of participants|||Number
2565697|NCT02590562|Secondary|Participant's Pain Assessment|Participants scored the intensity of pain produced by RA on 10 cm VAS from 0 = no pain to 10 = extreme pain.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||cm||Standard Deviation|Mean
2565698|NCT02590562|Secondary|Participant's Fatigue Assessment|Participants scored the fatigue on 10 cm VAS from 0 = no fatigue to 10 = very fatigue.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||cm||Standard Deviation|Mean
2565634|NCT02592434|Secondary|Double Blind Phase: Percentage of Participants With JADAS-27 CRP Inactive Disease Activity at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44|JADAS-27 inactive disease is defined by a JADAS score less than or equal to 1. JADAS-27 Inactive Disease cutoff values are defined as: 1) Polyarthritis: Inactive Disease: <=1 and 2) Oligoarthritis (<4 active joints): Inactive Disease: <=1. JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.|Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.|||percentage of participants|||Number
2565635|NCT02592434|Secondary|Open-Label Phase: Percentage of Participants With JADAS-27 CRP Inactive Disease Activity at Week 2, 4, 8, 12 and 18|JADAS-27 inactive disease is defined by a JADAS score less than or equal to 1. JADAS-27 Inactive Disease cutoff values are defined as: 1) Polyarthritis: Inactive Disease: <=1 and 2) Oligoarthritis (<4 active joints): Inactive Disease: <=1. JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.|Weeks 2, 4, 8, 12 and 18|The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||percentage of participants|||Number
2565636|NCT02592434|Secondary|Double Blind Phase: Percentage of Participants With JADAS-27 CRP Minimum Disease Activity at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44|Minimum Disease Activity is defined by a JADAS-27 CRP score less than or equal to 3.8 for participants with polyarthritis, and less than or equal to 2 for participants with oligoarthritis. JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.|Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.|||percentage of participants|||Number
2565637|NCT02592434|Secondary|Open-Label Phase: Percentage of Participants With JADAS-27 CRP Minimum Disease Activity at Weeks 2, 4, 8, 12 and 18|Minimum Disease Activity is defined by a JADAS-27 CRP score less than or equal to 3.8 for participants with polyarthritis, and less than or equal to 2 for participants with oligoarthritis. JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease(maximum of 27 defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.|Weeks 2, 4, 8, 12 and 18|The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||percentage of participants|||Number
2565638|NCT02592434|Secondary|Double Blind Phase: Change From Double-Blind Baseline in JADAS-27 Erythrocyte Sedimentation Rate (ESR) Score at Weeks 20, 24, 28, 32, 36, 40 and 44|JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) ESR. The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.|Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||score on scale||Standard Error|Least Squares Mean
2565699|NCT02590562|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|"The HAQ consists of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question has 4 response options, ranging from no difficulty to unable to do, corresponding to scores from 0 to 3. HAQ total score = sum of each of the 20 items' scores, with a summary score ranging from 0 to 60, where higher score indicates greater disability."|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2565639|NCT02592434|Secondary|Open Label Phase: Change From Baseline in JADAS-27 Erythrocyte Sedimentation Rate (ESR) Score at Week 2, 4, 8, 12 and 18|JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 ESR score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease (maximum of 27 and defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) ESR. The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.|Baseline, weeks 2, 4, 8, 12 and 18|The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||score on scale||Standard Deviation|Mean
2565640|NCT02592434|Secondary|Double Blind Phase: Change From Double-Blind Baseline in Juvenile Arthritis Disease Activity Score (JADAS) 27 C-Reactive Protein (CRP) Score at Week 20, 24, 28, 32, 36, 40 and 44|JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease(defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in mg/L and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.|Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||score on scale||Standard Error|Least Squares Mean
2565641|NCT02592434|Secondary|Open Label Phase: Change From Baseline in Juvenile Arthritis Disease Activity Score 27 (JADAS-27) C-Reactive Protein (CRP) Score at Weeks 2, 4, 8, 12 and 18|JADAS-27 is a validated composite disease activity measure for JIA. JADAS-27 CRP score was derived from four components; 1) Physician global assessment of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 2) Parent/legal guardian/subject global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor]), 3) Number of joints with active disease(defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 4) CRP (measured in milligram per liter [mg/L] and value normalized to 0 to 10 scale). The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.|Baseline, Weeks 2, 4, 8, 12 and 18|The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||score on scale||Standard Deviation|Mean
2565642|NCT02592434|Secondary|Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 100 Response at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44|JIA ACR100 response defined as: >=100% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.|Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.|||percentage of participants|||Number
2565643|NCT02592434|Secondary|Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 100 Response at Week 2, 4, 8, 12 and 18|JIA ACR100 response defined as: >=100% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.|Weeks 2, 4, 8, 12 and 18|The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||percentage of participants|||Number
2565670|NCT02591537|Secondary|Pain on Test Versus Control Side Using a Wong-Baker Scale.|Subjects will report pain level on each side of their abdomen at day 14. The Wong-Baker scale is: 0 points = no hurt, 2 = hurts little bit, 4 = hurts little more, 6 = hurts even more, 8 = hurts whole lot, 10 = hurts worst. A grand mean and standard deviation (reported below) were determined by combining participant scores.The identical group mean and standard deviation values reported below are correct.|Day 14|Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing. Five participants did not report their day 14 measurements.|||units on a scale|wounds|Standard Deviation|Mean
2566440|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Alanine Aminotransferase (U/L)||Baseline, Week 48|Participants with measurements at given time point.|||U/L||Standard Deviation|Mean
2565644|NCT02592434|Secondary|Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 90 Response at Double Blind Baseline (Week 18), Week 20, 24, 28, 32, 36, 40 and 44|JIA ACR90 response defined as: >=90% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.|Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36, 40 and 44|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.|||percentage of participants|||Number
2565645|NCT02592434|Secondary|Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 90 Response at Week 2, 4, 8, 12 and 18|JIA ACR90 response defined as: >=90% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.|Weeks 2, 4, 8, 12 and 18|The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here “n” signifies participants evaluable for this outcome measure at specified time points.|||percentage of participants|||Number
2565646|NCT02592434|Secondary|Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Response at Double Blind Baseline (Week 18),Week 20, 24, 28, 32, 36 and 40|JIA ACR70 response defined as: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.|Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36 and 40|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.|||percentage of participants|||Number
2565647|NCT02592434|Secondary|Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Response at Weeks 2, 4, 8, 12 and 18|JIA ACR70 response defined as: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.|Weeks 2, 4, 8, 12 and 18|The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||percentage of participants|||Number
2565648|NCT02592434|Secondary|Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Response at Double Blind Baseline, Weeks 20, 24, 28, 32, 36 and 40|JIA ACR50 response defined as: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.|Double blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36 and 40|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.|||percentage of participants|||Number
2565671|NCT02591537|Secondary|Wound Degree of Epithelialization Percent Change by Digital Photography at Each Time Point Post Wounding.|Wound degree of epithelialization percent change by digital photography at day 14.|Day 14|Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing.|||percentage of epithelialization|wounds|Standard Deviation|Mean
2565649|NCT02592434|Secondary|Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Response at Weeks 2, 4, 8, 12 and 18|JIA ACR50 response defined as: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.|Weeks 2, 4, 8, 12 and 18|The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||percentage of participants|||Number
2565650|NCT02592434|Secondary|Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Double Blind Baseline, Weeks 20, 24, 28, 32, 36 and 40|JIA ACR30 response defined as: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.|Double Blind Baseline (Week 18), Weeks 20, 24, 28, 32, 36 and 40|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.|||percentage of participants|||Number
2565651|NCT02592434|Secondary|Open-Label Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Weeks 2, 4, 8, 12 and 18|JIA ACR30 response defined as: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.|Weeks 2, 4, 8, 12 and 18|The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, “n” signifies participants evaluable for this outcome measure at specified time points.|||percentage of participants|||Number
2565652|NCT02592434|Secondary|Double Blind Phase: Time to Disease Flare|Time to disease flare: time (in days) from first dose of study drug until the day of disease flare in double blind phase. According to PRCSG/PRINTO, disease flare: worsening of >=30% in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. 6 core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.|Day 1 of Week 19 up to week 44|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.|||days||95% Confidence Interval|Median
2565653|NCT02592434|Secondary|Open-Label Phase: Time to Disease Flare|Time to disease flare:time (in days) from first dose of study drug until the day of disease flare in open-label phase. According to PRCSG/PRINTO, disease flare: worsening of >=30% in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. 6 core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.|Day 1 up to week 18|The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA.|||days||95% Confidence Interval|Median
2565672|NCT02591537|Primary|Healing in Days.|Wound healing will be defined as 90% re-epithelialization. Mean time to healing will be compared between the OxyGenesys treated sites and the control treated sites.|14 days|Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing.|||days|wounds|Standard Deviation|Mean
2565798|NCT02589171|Primary|Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively|Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.|6 weeks||||Participants|||Count of Participants
2565654|NCT02592434|Secondary|Double Blind Phase: Percentage of Participants With Disease Flare According to PRCSG/PRINTO Disease Flare Criteria at Week 20, 24, 28, 32, 36 and 40|According to PRCSG/PRINTO, disease flare defined as worsening of >=30% in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. Six core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.|Weeks 20, 24, 28, 32, 36 and 40|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.|||percentage of participants|||Number
2565655|NCT02592434|Secondary|Open-Label Phase: Percentage of Participants With Disease Flare According to Pediatric Rheumatology Collaborative Study Group/Pediatric Rheumatology International Trials Organization (PRCSG/PRINTO) Disease Flare Criteria at Week 2, 4, 8, 12 and 18|According to PRCSG/PRINTO, disease flare defined as worsening of >=30% in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. Six core variables were: 1) Number of joints with active arthritis (joint with swelling or in absence of swelling, limited range of motion accompanied by pain/ tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) ESR.|Weeks 2, 4, 8, 12 and 18|The OLJAS included all participants who were enrolled into the open-label phase of the study and received at least one dose of study medication in open-label phase and had polyarticular course JIA. Here, ‘number analyzed’ (n) signifies participants evaluable for this outcome measure at specified time points.|||percentage of participants|||Number
2565656|NCT02592434|Secondary|Double Blind Phase: JIA ACR Core Variable- Change From Double-Blind Baseline in Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) Total Score at Week 44|CHAQ is a valid assessment of functional disability, discomfort in participants with rheumatic diseases. It comprises of three indices: Disability and Discomfort, and global assessment of arthritis (overall well-being). CHAQ-DI: as a measure of functional ability, consists of 30 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed, among a total of 30 items. Each question was rated on a 4-point scale of difficulty in performance ranges from 0 (no difficulty) to 3 (unable to do). To calculate the overall score, the participant must have a domain score in at least 6 of the 8 domains. Scores of 8 domains were averaged to calculate the CHAQ-DI total score which ranges from 0 (no or minimal physical dysfunction) to 3 (very severe physical dysfunction), higher score indicates more disability. Change from double-blind baseline at Week 44 in DI total score is reported.|Baseline, Week 44|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2565657|NCT02592434|Secondary|Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 70 Response at Week 44|JIA ACR70 response defined as: >=70% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.|Week 44|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.|||percentage of participants|||Number
2565658|NCT02592434|Secondary|Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 Response at Week 44|JIA ACR30 response defined as: >=30% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.|Week 44|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.|||percentage of participants|||Number
2565673|NCT02591511|Primary|Stroke Health Education Knowledge Questionnaire|The stroke knowledge questionnaire is the primary outcome of this study. The questions are single-choice questions. The content of the questions are based on the stroke health education manual and adapted to APP format in this study. For the 12 risk factors, each risk factor was sorted out 3 questions. There are total of 36 (3x12 = 36) questions of stroke knowledge, a score of 1 for each question, the highest score of 3 for each risk factor, the highest score of 36 points and the lowest score of 0 point. The higher score represents the better outcome.|4 weeks||||score on a scale||Standard Deviation|Mean
2565659|NCT02592434|Secondary|Double Blind Phase: Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 50 Response at Week 44|JIA ACR50 response defined as: >=50% improvement in 3 out of 6 JIA core set variables with no more than 1 out of 6 JIA core set variables worsened by >=30%. Six core variables: 1) Number of joints with active arthritis (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness), 2) Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a VAS of 0 [no activity] to 10 [maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on a VAS of 0 [very well] to 10 [very poor], 5) CHAQ-DI: 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score, which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction); 6) ESR.|Week 44|The DBJAS included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.|||percentage of participants|||Number
2565660|NCT02592434|Primary|Double Blind Phase: Percentage of Participants With Disease Flare According to Pediatric Rheumatology Collaborative Study Group/Pediatric Rheumatology International Trials Organization (PRCSG/PRINTO) Disease Flare Criteria at Week 44|According to PRCSG/PRINTO, disease flare defined as worsening of >=30 percent(%) in >=3 of 6 variables of JIA core set, with no more than 1 variable improving by >=30%. Six core variables: 1) Number of joints with active arthritis (joint with swelling/in absence of swelling, limited range of motion accompanied by pain/tenderness), 2)Number of joints with limited range of motion, 3) Physician global evaluation of disease activity (assessed on a Visual Analog Scale[VAS] of 0[no activity] to 10[maximum activity]), 4) Parent/legal guardian/participant global assessment of overall well-being (assessed on VAS of 0[very well] to 10[very poor], 5) Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI): 30 questions in 8 domains, each question answered on scale of 0=without difficulty to 3=unable to do; scores of each domain were averaged to derive total CHAQ-DI score,which ranges from 0 (minimum dysfunction) to 3 (most severe dysfunction);6) Erythrocyte Sedimentation Rate(ESR).|Week 44|The Double Blind polyarticular course JIA analysis set (DBJAS) included all participants randomized to the double-blind phase, received at least 1 dose of study medication in the double-blind phase and had polyarticular course JIA.|||percentage of participants|||Number
2565661|NCT02592421|Secondary|Change in Glucagon During EGP Measurement|Measurement of change in glucagon during EGP measurement from baseline to the last hour of the study|Baseline to 240-300 minutes||||ng/ml||Standard Deviation|Mean
2565662|NCT02592421|Secondary|Change in Plasma Insulin During Measurement of EGP|Measurement of change in plasma insulin concentration during measurement of of EGP from baseline to last hour of the study|Baseline to 240-300 minutes||||microUnits/mL||Standard Deviation|Mean
2565663|NCT02592421|Primary|Change in Endogenous Glucose Production (EGP)|The change in endogenous glucose production is measured from baseline until the last hour of the study|Baseline to 240-300 minutes||||mg/kg.min||Standard Deviation|Mean
2565664|NCT02592421|Primary|Change in Plasma Glucose Concentration|Change from baseline to the last hour of the study (240-300 minutes) in plasma glucose concentration|Baseline to 240-300 minutes||||mg/dl||Standard Deviation|Mean
2565665|NCT02591537|Secondary|Scar Quality Analysis; Colorimeter|Scar quality was to be assessed for each study participant using a colorimeter at day 42. A colorimeter was to be used to measure the extent of erythema, and melanin content, of the skin. Unfortunately, the data for this study endpoint were not collected properly, and despite our best efforts, there is no way to resolve this issue. Thus, no data can be reported for this study outcome.|Day 42|Data were not collected.||||||
2565666|NCT02591537|Secondary|Scar Quality Analysis; Elastometer|Scar quality was to be assessed for each study participant using an elastometer at day 42. An elastometer is used to assess scar elasticity. Unfortunately, the data for this study endpoint were not collected properly, and despite our best efforts, there is no way to resolve this issue. Thus, no data can be reported for this study outcome.|Day 42|Data were not collected.||||||
2565667|NCT02591537|Secondary|Scar Quality Analysis; Visual Analogue Scale|Scar quality of each study participant was assessed by using the Visual Analogue Scale (VAS) at day 42. The VAS is an 11-point scale that ranges from 0 (normal skin) to 10 (worst possible scar). The values on the scale indicate the observer's global impression of the scar (lower numbers are better than higher numbers).|Day 42|Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing. One participant did not report for her day 42 measurement.|||units on a scale|wounds|Standard Deviation|Mean
2565668|NCT02591537|Secondary|Scar Quality Analysis; Modified Vancouver Scar Scale (MVS)|Scar quality will be assessed and analyzed between the two groups using the Modified Vancouver Scar Scale at day 42. The MVS assessment is the tool that the Investigator will use to evaluate scar pliability (0 points = normal, 1 = supple, 2 = yielding, 3 = firm, 4 = adherent), height (0 = normal, 1 = 1-2 mm, 2 = 3-4 mm, 3 = 5-6 mm, 4 = > 6 mm), vascularity (0 = normal, 1 = pink, 2 = red, 3 = purple), and pigmentation (0 = normal, 1 = slight, 2 = moderately, 3 = severely). An average score for each participant was calculated by combining scores from each subscale. Average participant scores in each study group were combined to produce a grand mean and standard deviation for each group (reported below).|Day 42|Each participant was assigned to both study groups (acted as her own control), as four wounds on one side of each participant were treated with OxyGenesys dressing, and four wounds on the opposite side of each participant were treated with the Tegaderm control dressing. One participant did not report for her day 42 measurement.|||units on a scale|wounds|Standard Deviation|Mean
2565669|NCT02591537|Secondary|Biopsy & Histology of Wounds.|Biopsies will be taken from all wounds at day 28. Analysis of tissue samples will specifically evaluate differences and rates of collagen deposition, angiogenesis and re-epithelialization between the two study arms.|Day 28|Each participant was assigned to both study groups (acted as her own control). Samples were collected, but not analyzed because the comparative broad healing endpoints did not provide compelling evidence for tissue processing. No data are presented because the Outcome Measure has zero total participants analyzed.||||wound biopsies||
2565799|NCT02589171|Primary|Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively|Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.|1 week||||Participants|||Count of Participants
2565674|NCT02591290|Other Pre-specified|Number of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Vaccination|Solicited injection (Inj.) site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference), erythema and swelling (Grade 1: >=25 to <=50 mm; Grade 2: >=51 to <=100 mm; Grade 3: >100 mm); Solicited systemic reactions: Fever (Grade 1: >=37.5 degree Celsius to <=38.4 degree Celsius, Grade 2: >=38.5 degree Celsius to <=38.9 degree Celsius, Grade 3: >=39.0 degree Celsius), headache, malaise and myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any of the Grade 1, 2 or 3 solicited injection-site and systemic reactions and Grade 3 solicited injection-site and systemic reactions were reported.|Within 7 days post-vaccination 1, Within 7 days post-vaccination 2|Safety analysis set included all participants who received at least 1 dose of study vaccine.|||Participants|||Count of Participants
2565675|NCT02591290|Other Pre-specified|Number of Participants With >=4-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers Following Vaccination|Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR in the serum specimens. Number of participants with >=4-fold rise in each meningococcal serogroups antibody titer at Day 28 post-vaccination 1 and at Day 28 post-vaccination 2 were reported.|Day 28 post-vaccination 1, Day 28 post-vaccination 2|PP analysis set included all participants who received 2 study vaccinations and provided the valid blood samples of pre-vaccination and post-1st and post-2nd vaccination.|||Participants|||Count of Participants
2565676|NCT02591290|Primary|Number of Participants With Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers >=1:128|Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by Serum Bactericidal Assay using Baby Rabbit complement (SBA-BR).|Day 0 (pre-vaccination), Day 28 post-vaccination 1, Day 28 post-vaccination 2|Per Protocol (PP) analysis set included all participants who received 2 study vaccinations and provided the valid blood samples of pre-vaccination and post-1st and post-2nd vaccination.|||Participants|||Count of Participants
2565677|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of LDL-C.||Three months.|Bellow concentration data of LDL-C was after treatment with oral melatonin 2 weeks.|||mmol/L||Standard Deviation|Mean
2565678|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TG.||Three months.|Bellow concentration data of TG was after treatment with oral melatonin 2 weeks.|||mmol/L||Standard Deviation|Mean
2565679|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of TC.||Three months.|Bellow concentration data of TC was after treatment with oral melatonin 2 weeks.|||mmol/L||Standard Deviation|Mean
2565680|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of FFA.||Three months.|Below concentration data of FFA was after treatment with oral melatonin 2 weeks.|||umol/L||Standard Deviation|Mean
2565681|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Glu.||Three months.|Bellow concentration data of Glu was after treatment with oral melatonin 2 weeks.|||mmol/L||Standard Deviation|Mean
2565682|NCT02591238|Primary|Smoke-induced Vascular Injury and Melatonin's Effect in This Process Assessed by the Concentration of Fbg.||Three months|Bellow concentration data of Fbg was after treatment with oral melatonin 2 weeks.|||g/L||Standard Deviation|Mean
2565683|NCT02591056|Primary|Change in Combined Circumference Measurements|Combined circumference measurement is calculated as the sum of the measurements for the individual body areas of the hips, waist and upper abdomen. Change in combined circumference measurements is calculated as the difference in measurements from baseline to after completion of the 6-week procedure administration period. A negative (-) change indicates a reduction in combined circumference measurement across the evaluation period and is positive for study success. A positive (+) change indicates an increase in combined circumference measurements across the evaluation period and is negative for study success. A mean change for the study subject group of -3.0 inches or more in combined circumference measurements will be considered a clinically meaningful and statistically significant positive change indicative of study success.|Baseline and 6 Weeks||||inches||Standard Deviation|Mean
2565684|NCT02590939|Secondary|Pain Score 24 Hours|Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 24 hours compared to baseline (if rescue therapy was not used)|24 hours||||units on a scale||Standard Deviation|Mean
2565685|NCT02590939|Secondary|Pain Score 2 Hours|Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 2 hours compared to baseline (if rescue therapy was not used)|2 hours||||units on a scale||Standard Deviation|Mean
2565686|NCT02590939|Secondary|Pain Score 24 Hours|Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 24 hours compared to baseline (if rescue therapy was not used)|24 hours||||percent change||Standard Deviation|Mean
2565687|NCT02590939|Secondary|Rescue Medication 24 Hours|Number of patients not having required rescue medication within 24 hours|24 hours||||Participants|||Count of Participants
2565688|NCT02590939|Secondary|Pain Score 2 Hours|Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 2 hours compared to baseline (if rescue therapy was not used)|2 hours||||percent change||Standard Deviation|Mean
2565689|NCT02590939|Secondary|Rescue Medication 2 Hours|Number of patients not having required rescue medication at 2 hours|2 hours||||Participants|||Count of Participants
2565690|NCT02590939|Primary|Pain Score 1-hour|Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 1 hour compared to baseline|1 hour||||units on a scale||Standard Deviation|Mean
2565691|NCT02590939|Primary|Pain Score 1-hour|Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 1 hour compared to baseline|1 hour||||percent change||Standard Deviation|Mean
2565800|NCT02589171|Primary|Technical Effectiveness as Assessed by Number of Participants With Surgical Site Occurrences Post-Operatively|Surgical site occurrences include hematoma, seroma, or infection and were assessed by physical exam.|immediately post op||||Participants|||Count of Participants
2565700|NCT02590562|Secondary|Patient's Global Assessment (PtGA) of Disease Activity|PtGA of disease activity was measured on a 0 to 10 cm VAS, with 0 cm = very well controlled and 10 cm = very poorly controlled.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||cm||Standard Deviation|Mean
2565701|NCT02590562|Secondary|Physician's Global Assessment (PGA) of Disease Activity|PGA of disease activity was measured on a 0 to 10 centimeter (cm) VAS, with 0 cm = no disease activity and 10 cm = extreme disease activity.|Day 1 (enrollment visit)|Overall Population|||cm||Standard Deviation|Mean
2565702|NCT02590562|Secondary|DAS28 by Biological Agent as Monotherapy or Combination With csDMARDs|Biological agent monotherapy meant participants using a biological agent without concomitant csDMARDs. DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2565703|NCT02590562|Secondary|DAS28 by Duration of Treatment of Biological Agent|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure in respective arms.|||units on a scale||Standard Deviation|Mean
2565704|NCT02590562|Secondary|Number of Participants With Duration of Treatment of Biological Agent|Number of participants with duration of treatment of biological agent <3 months, >= 3 to <6 months, >= 6 to <12 months, and >= 12 months.|Day 1 (enrollment visit)|Overall Population|||participants|||Number
2565705|NCT02590562|Secondary|Number of Participants Experiencing High Disease Activity to Clinical Remission Using the SDAI|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
2565706|NCT02590562|Secondary|Simplified Disease Activity Index (SDAI)|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2565707|NCT02590562|Secondary|Number of Participants Experiencing High Disease Activity to Clinical Remission Using the CDAI|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
2565708|NCT02590562|Secondary|Clinical Disease Activity Index (CDAI) Scores|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and Physician's Global Assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2565709|NCT02590562|Secondary|Number of Participants Experiencing High Disease Activity to Clinical Remission Using the DAS28|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
2565726|NCT02590562|Secondary|Number of Participants With Concurrent RA Extra-articular Symptoms|Number of participants with concurrent RA extra-articular symptoms including RA subcutaneous nodule, RA vasculitis, interstitial pneumonia, Felty's syndrome, and other symptoms were presented. One participant could have more than one concurrent RA extra-articular symptoms.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
2565710|NCT02590562|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and Patient's Global Assessment (PtGA) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity; DAS28-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(10*CRP+1) + 0.014*PtGA of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2565711|NCT02590562|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28.|Day 1 (enrollment visit)|Overall Population|||tender joint count||Standard Deviation|Mean
2565712|NCT02590562|Secondary|Swollen Joint Count (SJC)|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28.|Day 1 (enrollment visit)|Overall Population|||swollen joint count||Standard Deviation|Mean
2565713|NCT02590562|Secondary|Number of Participants With Abnormal Total Cholesterol Values|Normal range for total cholesterol is <5.2 mmol/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
2565714|NCT02590562|Secondary|Total Cholesterol Values|Normal range for total cholesterol is <5.2 mmol/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||mmol/L||Standard Deviation|Mean
2565715|NCT02590562|Secondary|Number of Participants With Abnormal Triglyceride Values|Normal range for triglyceride is <1.7 mmol/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
2565716|NCT02590562|Secondary|Triglyceride Values|Normal range for triglyceride is <1.7 millimoles per liter (mmol/L).|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||mmol/L||Standard Deviation|Mean
2565717|NCT02590562|Secondary|Number of Participants With Positive Rheumatoid Factor (RF)|"RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. Central lab was not used in this study; the definitions of positive RF followed participating hospitals' standardized criteria. CRF collected data as positive or negative directly."|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
2565718|NCT02590562|Secondary|Number of Participants With Positive Anti-cyclic Citrullinated Peptide (ACCP) Antibody|"ACCP antibodies are important markers of bone erosion in RA. Central lab was not used in this study; the definitions of positive ACCP followed participating hospitals' standardized criteria. CRF collected data as positive or negative directly."|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
2565719|NCT02590562|Secondary|Number of Participants With Anemia|Anemia was defined as an adult male with hemoglobin value <120 g/L or an adult female with hemoglobin value <110 g/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
2565720|NCT02590562|Secondary|Hemoglobin Values|Hemoglobin levels were measured in gram per liter (g/L). Anemia was defined as an adult male with hemoglobin value <120 g/L or an adult female with hemoglobin value <110 g/L.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||g/L||Standard Deviation|Mean
2565721|NCT02590562|Secondary|Number of Participants With Abnormal ESR Values|"ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation. Central lab was not used in this study; the definitions of abnormal ESR followed participating hospitals' standardized criteria. CRF collected data as directly normal or abnormal."|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
2565722|NCT02590562|Secondary|Erythrocyte Sedimentation Rate (ESR) Values|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. A higher rate is consistent with inflammation.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||mm/hr||Standard Deviation|Mean
2565723|NCT02590562|Secondary|Number of Participants With Abnormal CRP Values|"The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Central lab was not used in this study; the definitions of abnormal CRP followed participating hospitals' standardized criteria. Case report form (CRF) collected data as directly normal or abnormal."|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
2565724|NCT02590562|Secondary|C-Reactive Protein (CRP) Values|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||mg/L||Standard Deviation|Mean
2565725|NCT02590562|Secondary|Number of Participants With Concurrent Interstitial Lung Disease Using Methotrexate||Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
2565727|NCT02590562|Secondary|Number of Participants With RA Duration|Number of participants with RA duration of <= 6 months, >6 months and <= 3 years, >3 years and <= 10 years, and 10 years.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
2565728|NCT02590562|Secondary|RA Duration Since Diagnosis|RA duration = (the date of participants signing the informed consent form - date of RA diagnosis + 1) /365.25|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||years||Standard Deviation|Mean
2565729|NCT02590562|Secondary|Number of RA Related Operations|RA related operations also included prosthesis.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||RA related operations||Standard Deviation|Mean
2565730|NCT02590562|Secondary|Height||Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||centimeters (cm)||Standard Deviation|Mean
2565731|NCT02590562|Secondary|Weight||Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||kilograms||Standard Deviation|Mean
2565732|NCT02590562|Secondary|Number Participants With Past Medical History of Concurrent Chronic Disease, Tuberculosis, Hepatitis, and Imaging Manifestations of Joint Damage||Day 1 (enrollment visit)|Overall Population|||participants|||Number
2565733|NCT02590562|Primary|Average Daily Dose of Each Previously Concomitant NSAIDs|One participant could have received multiple concomitant NSAIDs treatment.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.|||mg/day||Standard Deviation|Mean
2565734|NCT02590562|Primary|Average Daily Dose of Each Currently Concomitant NSAIDs|One participant could have received multiple concomitant NSAIDs treatment.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.|||mg/day||Standard Deviation|Mean
2565735|NCT02590562|Primary|Average Duration of Treatment With Each Concomitant csDMARD|One participant could have received multiple concomitant csDMARDs treatment.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.|||weeks||Standard Deviation|Mean
2565736|NCT02590562|Primary|Average Weekly Dose of Each Concomitant csDMARD|One participant could have received multiple concomitant csDMARDs treatment.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.|||mg/week||Standard Deviation|Mean
2565737|NCT02590562|Primary|Number of Participants Using One, Two, or Three (or More) Concomitant csDMARDs|Number of participants using one concomitant csDMARD, two concomitant csDMARDs (methotrexate + hydroxychloroquine [HCQ], methotrexate + salazosulfapyridine [SASP], methotrexate+ leflunomide, SASP + HCQ, and other combinations), or three (or more) concomitant csDMARDs (methotrexate + SASP + HCQ, and other combinations) are presented.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
2565738|NCT02590562|Primary|Average Duration of Treatment With Each Concomitant External Medicine||Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with available data for specified category.|||weeks||Standard Deviation|Mean
2565739|NCT02590562|Primary|Average Weekly Dose of Each Concomitant Glucocorticoid|Average weekly dose of each concomitant glucocorticoid (prednisone acetate, oral; betamethasone [BMZ] dipropionate and betamethasone sodium phosphate, intra-articular (IA) injection; and methylprednisolone, intravenous drip infusion, oral) is presented.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with specified concomitant glucocorticoid treatment.|||mg/week||Standard Deviation|Mean
2565740|NCT02590562|Primary|Number of Participants With Reasons for Switching Types of Biological Agent Who Used a Different Biological Agent in the Past|Participants who used a different biological agent in the past and switched are shown by reason for switching. One participant could have switched types of biological agent due to multiple reasons.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
2565741|NCT02590562|Primary|Number of Participants With Previous Use of the Same Biological Agent|Participants who used the same biological agent in the past and were using that same biological agent at the time of study enrollment.|Day 1 (enrollment visit)|Overall Population|||participants|||Number
2565742|NCT02590562|Primary|Average Duration of Treatment for Each Biological Agent|Average duration of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented.|Day 1 (enrollment visit)|Overall Population. n = participants with specified treatment of biological agent.|||weeks||Standard Deviation|Mean
2565743|NCT02590562|Primary|Average Weekly Dose of Treatment for Each Biological Agent|Average weekly dose of treatment of each biological agent (adalimumab, tocilizumab, etanercept, or infliximab) is presented.|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure. n = participants with specified treatment of biological agent.|||milligrams (mg) per week||Standard Deviation|Mean
2565744|NCT02590562|Primary|Number of Participants Receiving a Biological Agent as Monotherapy by Types of Biological Agents|Number of participants who received a biological agent as monotherapy is presented by biological agent (adalimumab, tocilizumab, etanercept, and infliximab).|Day 1 (enrollment visit)|Overall Population. Number of participants analyzed = participants evaluable for this outcome measure.|||participants|||Number
2565745|NCT02590562|Primary|Number of Participants Receiving a Biological Agent Concomitant With Other Drugs|Number of participants receiving treatment of a biological agent concomitant with the following drugs: glucocorticoid, NSAIDs, other external medicine, or concomitant glucocorticoid and concomitant NSAIDs. The same participant could use 2 or 3 of concomitant glucocorticoid, NSAIDs and other external medicine.|Day 1 (enrollment visit)|Overall Population|||participants|||Number
2565789|NCT02589171|Secondary|Pain as Assessed by Number of Participants Who Took Pain Medications||week 6||||Participants|||Count of Participants
2565746|NCT02590562|Primary|Number of Participants Receiving Biological Agent as Monotherapy or in Combination With Conventional Synthesis Disease-modifying Anti-rheumatic Drugs (csDMARDs) Therapy|Biological agent monotherapy meant participants using a biological agent without concomitant csDMARDs. Biological agent monotherapy included biological agent only, biological agent + glucocorticoid, biological agent + non-steroidal anti-inflammatory drugs [NSAIDs], and biological agent + glucocorticoid + NSAIDs.|Day 1 (enrollment visit)|Overall Population|||participants|||Number
2565747|NCT02590432|Secondary|Time to First Recurrence of Intolerable Diarrhea|Time to first recurrence of intolerable diarrhea was defined as event/censored date - double-blind start date + 1, where event date (responders) = first recurrence of intolerable diarrhea date during the double-blind treatment period; censoring date (non-responders) = double-blind end date. Only includes participants reporting intolerable diarrhea during the open-label treatment period.|From first dose in the Double-blind Treatment Period to Week 52|Double-blind safety population consisted of all participants in the randomized population who received ≥ 1 dose of study treatment during the Double-blind Treatment Period. Number of Participants Analyzed were the participants reporting intolerable diarrhea during the Open-label Treatment Period.|||days||95% Confidence Interval|Median
2565748|NCT02590432|Secondary|Time to First Recurrence of Diarrhea|Time to first recurrence of diarrhea was defined as event/censored date - double-blind start date + 1, where event date (responders) = first recurrence of diarrhea date during the double-blind treatment period; censoring date (non-responders) = double-blind end date. Only includes participants reporting intolerable diarrhea during the open-label treatment period.|From first dose in the Double-blind Treatment Period to Week 52|Double-blind safety population consisted of all participants in the randomized population who received ≥ 1 dose of study treatment during the Double-blind Treatment Period. Number of Participants Analyzed were the participants reporting intolerable diarrhea during the Open-label Treatment Period.|||days||95% Confidence Interval|Median
2565749|NCT02590432|Secondary|Percentage of Participants With Treatment Emergent Adverse Events (TEAE)|An adverse event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period.|From first dose of study treatment up to Week 52|Safety population included all participants in the screened population who received ≥ 1 administration of study treatment.|||percentage of participants|||Number
2565750|NCT02590432|Secondary|Number of Participants With Recurrence of Intolerable Diarrhea|Participants reporting any instance of intolerable diarrhea during the Double-blind Treatment Period (Non-responder otherwise). Only includes participants reporting intolerable diarrhea during the Open-label Treatment Period.|From first dose in the Double-blind Treatment Period to Week 52|Double-blind safety population consisted of all participants in the randomized population who received ≥ 1 dose of study treatment during the Double-blind Treatment Period. Number of Participants Analyzed were the participants reporting intolerable diarrhea during the Open-label Treatment Period.|||Participants|||Count of Participants
2565751|NCT02590432|Secondary|Number of Participants With Recurrence of Diarrhea|Participant reporting any instance of diarrhea during the Double-blind Treatment Period.|From first dose in the Double-blind Treatment Period to Week 52|Double-blind safety population consisted of all participants in the randomized population who received ≥ 1 dose of study treatment during the Double-blind Treatment Period. Number of Participants Analyzed were the participants reporting intolerable diarrhea during the Open-label Treatment Period.|||Participants|||Count of Participants
2565752|NCT02590432|Secondary|Constipation Treatment Satisfaction Assessment Postbaseline for Participants With Chronic Idiopathic Constipation (CIC)|Participants rated degree of satisfaction with LINZESS®'s ability to relieve constipation symptoms on a 5-point ordinal scale where 1=Not at all satisfied, 2=A little satisfied, 3=Moderately satisfied, 4=Quite satisfied and 5=Very satisfied. Higher scores indicate greater satisfaction.|Weeks 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period)|ITT population consisted of all participants in the safety population who had ≥ 1 postbaseline assessment for any efficacy or health outcomes parameter. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
2565753|NCT02590432|Secondary|IBS Treatment Satisfaction Assessment Postbaseline for Participants With IBS-C|Participants rated degree of satisfaction with the LINZESS®'s ability to relieve IBS symptoms on a 5-point ordinal scale where, 1=Not at all satisfied, 2=A little satisfied, 3=Moderately satisfied, 4=Quite satisfied and 5=Very satisfied. Higher scores indicate greater satisfaction.|Weeks 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period)|ITT population included all participants in the safety population who had ≥ 1 postbaseline assessment for any efficacy or health outcomes parameter. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
2565754|NCT02590432|Secondary|Change From Baseline in Degree of Relief of IBS Symptoms for Participants With IBS-C|Participants rated degree of relief of IBS symptoms during previous 7 days on a 7-point balanced ordinal scale where, 1=completely relieved, 2=considerably relieved, 3=somewhat relieved, 4=unchanged, 5=somewhat worse, 6=considerably worse and 7=as bad as I can imagine. Lower scores indicate greater relief. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Weeks 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period)|Intent-to-treat (ITT) population included all participants in the safety population who had ≥ 1 postbaseline assessment for any efficacy or health outcomes parameter. Number analyzed were the participants with analysis values at both baseline and postbaseline during the specified time period.|||score on a scale||Standard Deviation|Mean
2565790|NCT02589171|Secondary|Pain as Assessed by Number of Participants Who Took Pain Medications||week 1||||Participants|||Count of Participants
2565791|NCT02589171|Secondary|Pain at the Stapler Port Site as Assessed by a Visual Analog Scale|Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.|6 weeks||||units on a scale||Standard Deviation|Mean
2565755|NCT02590432|Secondary|Change From Baseline in Participant Assessment of Irritable Bowel Syndrome (IBS) Symptom Severity for Participants With Irritable Bowel Syndrome With Constipation (IBS-C)|Participants rated IBS symptoms severity during the previous 7 days on a 5-point ordinal scale where, 1=None, 2=Mild, 3=Moderate, 4=Severe and 5=Very severe. Higher scores indicate greater severity. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Week 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period)|ITT population consisted of all participants in the safety population who had ≥ 1 postbaseline assessment for any efficacy or health outcomes parameter. Number analyzed were the participants with analysis values at both baseline and postbaseline during the specified time period.|||score on a scale||Standard Deviation|Mean
2565756|NCT02590432|Secondary|Change From Baseline in Participant's Assessment of Constipation Severity|Participants rated constipation severity during the previous 7 days on a 5-point ordinal scale where, 1=None, 2=Mild, 3=Moderate, 4=Severe and 5=Very Severe. Higher scores indicate greater severity. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Weeks 2, 4, 12, 26, 40 and 52 (Open Label Treatment Period)|Intent to Treat (ITT) population included all participants in the safety population who had ≥ 1 postbaseline assessment for any efficacy or health outcomes parameter. Number analyzed were the participants with analysis values at both baseline and postbaseline during the specified time period.|||score on a scale||Standard Deviation|Mean
2565757|NCT02590432|Primary|Number of Participants With Positive Treatment-Related Anti-Drug Antibodies (ADA) in Serum|Participants who met either of the following criteria: 1) treatment-induced ADA-positive (≥ 1 postbaseline ADA-positive sample) for baseline ADA negative or ADA-undetermined participants or 2) treatment-boosted ADA-positive (≥ 1 postbaseline ADA-positive sample with titer values ≥ 4-fold the baseline titer value) for baseline ADA-positive participants were reported as a ADA positive responder.|Baseline (Day 1) up to 52 weeks or 8 months post last dose if ADA positive at Week 52 (approximately 84 weeks)|Safety population included all participants in the screened population (all participants who had signed an informed consent form (ICF) for the study and received a patient identification number) who received ≥ 1 administration of study treatment. Participants with ≥ 1 assessable postbaseline sample were analyzed (ADA-undetermined excluded).|||Participants|||Count of Participants
2565758|NCT02590406|Secondary|Hemodynamic Changes|Evaluation of the changes in vital signs during and after the pre-oxygenation phase in the two combinations of position and ventilation mode|From the beginning of the pre-oxygenation to the end of the protocol|||||||
2565759|NCT02590406|Secondary|Time to 97% Saturation||Evaluation of the time needed to the beginning of the ventilation to the moment where the saturation is 97%|4 values missing in the BC group and 5 values missing in RT group.|||seconds||Standard Deviation|Mean
2565760|NCT02590406|Secondary|Minimum Arterial Saturation of Oxygen Obtained|Evaluation of the minimal saturation obtained after the resumption of the ventilation|After the end of the Non-hypoxic apnea time|One patient missing in the BC group|||percent||Standard Deviation|Mean
2565761|NCT02590406|Secondary|Maximum Expired Fraction of Oxygen Obtained|Evaluation of the maximum expired oxygen fraction obtained in the two groups|After 3 minutes of pre-oxygenation||||Maximum expired fraction of oxygen obtai||Standard Deviation|Mean
2565762|NCT02590406|Secondary|Time to Expired Oxygen Fraction > 0,9|Evaluation of time needed to obtain an expired fraction of oxygen of > 0,9 in the two groups during the pre-oxygenation|During the pre-oxygenation period||||seconds||Standard Deviation|Mean
2565763|NCT02590406|Primary|Non Hypoxic Apnea Time|Change of Non-hypoxic apnea time in obese patient during a General Anesthesia induction, as a result of different pre-oxygenation position and ventilation mode; 1-Beach Chair and No positive pressure ventilation, 2-Reverse Trendelenburg and positive pressure ventilation and PEEP. End of measure time frame is 5 minutes after intubation|After a 3 minutes pre-oxygenation period||||seconds||Standard Deviation|Mean
2565764|NCT02590354|Secondary|Assessment of the Kinetics of HIV Viral Load Rebound After Treatment Interruption Based on the Repetitive Plasma Viral Load Measurements.|The kinetics will be on the plasma viral load (expressed in copies/ml) measured two-weekly (or four-weekly after W12) until W48 after treatment interruption. A viral load of 19 means <20 copies/mL (lower limit of detection).|At screening, baseline, week 2, week 4, week 6, week 8, End of Intervention (relapse), 4 weeks after relapse and 12 weeks after relapse|The population analyzed are the subjects enrolled in phase 2 (treatment interruption).|||copies/mL||Inter-Quartile Range|Median
2565765|NCT02590354|Secondary|Evaluation of the Reservoir Replenishment Upon Interruption of Antiretroviral Treatment (TI) by Quantifying the Viral Reservoir at Baseline (i.e. Just Before TI) and at Viral Rebound (Unspliced RNA).|Assessment of the viral reservoir magnitude on cryopreserved Peripheral Blood Mononuclear Cells (PBMCs) prior and after treatment interruption by means of unspliced RNA.|At screening, baseline, week 2, week 4, week 6, week 8 and at 12 weeks after relapse|Population analyzed are the subjects enrolled in phase 2 (treatment interruption).|||copies/10^6PBMCs||Inter-Quartile Range|Median
2565766|NCT02590354|Secondary|Evaluation of the Reservoir Replenishment Upon Interruption of Antiretroviral Treatment (TI) by Quantifying the Viral Reservoir at Baseline (i.e. Just Before TI) and at Viral Rebound (Total HIV DNA).|Assessment of the viral reservoir magnitude on cryopreserved Peripheral Blood Mononuclear Cells (PBMCs) prior and after treatment interruption by means of Total HIV DNA.|At screening, baseline, week 2, week 4, week 6, week 8 and at 12 weeks after relapse|Population analyzed are the subjects enrolled in phase 2 (treatment interruption).|||copies/10^6PBMCs||Inter-Quartile Range|Median
2565767|NCT02590354|Secondary|Number of Patients With and the Severity of Adverse Events That Are Related to the Study Intervention, Graded According to NCI CTCAE Version 4.0|Confirmation of the safety of a treatment interruption strategy in selected patients will be based on the number and intensity of AEs graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE) on a five-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening and Death).|23 months|Population analyzed are the subject enrolled in het treatment interruption phase.|||Participants|||Count of Participants
2565792|NCT02589171|Secondary|Pain at the Stapler Port Site as Assessed by a Visual Analog Scale|Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.|1 week||||units on a scale||Standard Deviation|Mean
2565793|NCT02589171|Secondary|Pain at the Stapler Port Site as Assessed by a Visual Analog Scale|Pain Score is based on a visual analog scale (VAS), with a range of 0 to 10. 0 indicates no pain and 10 indicates the most painful.|day 1||||units on a scale||Standard Deviation|Mean
2565768|NCT02590354|Primary|Assessment of the Number of Participants With a HIV Plasma Viral Load Below the Lower Limit of Detection 48 Weeks Following Interruption of Antiretroviral Treatment|The number of post treatment controllers (PTC - i.e. patients under ART at baseline that show low peripheral blood proviral DNA and still will show sustained viral suppression at 48 weeks after treatment interruption) will be determined. The assessment will be based on the plasma viral load (expressed in copies/ml) measured two-weekly (or four-weekly after W12) until W48 after treatment interruption. Patients below the lower limit of detection (<50 HIV RNA copies/ml plasma) at 48 weeks after treatment interruption will be considered as PTC.|48 weeks after treatment interruption|Analysis population contains all subjects enrolled in phase 2 (treatment interruption phase)|||Participants|||Count of Participants
2565769|NCT02590068|Secondary|Interferon-gamma Response|Interferon-gamma response: by ELIspot expressed as number of spot-forming cells per million PBMCs|18 months|Samples were not analyzed and no assays were performed for this protocol.||||||
2565770|NCT02590068|Secondary|Responder Cell Frequency|Responder cell frequency: VZV specific CD4+ T cells post-vaccination (expressed in %)|18 months|Samples were not analyzed and no assays were performed for this protocol.||||||
2565771|NCT02590068|Secondary|Serum Biomarkers of Immune Activation(Expressed in%)|Serum biomarkers of immune activation will be measured and expressed in percentage.|18 months|Samples were not analyzed and no assays were performed for this protocol.||||||
2565772|NCT02590068|Secondary|Interferon Stimulated Gene (ISG) Expression|Interferon stimulated gene (ISG) expression in PBMC will be expressed as fold-change (FCH) above baseline|18 months|Samples were collected and cryopreserved. RNA was collected for these samples and batched, but the RNA-Seq (for RNA expression measurements) was not run. The samples wee not analyzed and no assays were performed for this protocol.||||||
2565773|NCT02590068|Primary|Serum Zoster Antibody Level|Serum zoster antibody level would be measured by gpELISA expressed in (units/mL)|18 months|Samples were collected but none were tested for antibody levels||||||
2565774|NCT02590003|Secondary|Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)|The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. Symptoms were measured following 4 21-day cycles of chemotherapy.|week 12|The study was terminated after only 3 patients were randomized and all 3 did not respond to treatment, these data were not collected at week 12||||||
2565775|NCT02590003|Secondary|Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)|The higher the score, the greater the symptoms. The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. A maximum score of 136 could be obtained. Symptoms were measured following 2 21-day cycles of chemotherapy.|week 6|Only 2 patients were assessed at this timepoint.|||units on a scale||Standard Deviation|Mean
2565776|NCT02590003|Secondary|Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)|The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. A maximum score of 136 could be obtained.|baseline||||units on a scale||Standard Deviation|Mean
2565777|NCT02590003|Secondary|Grade 3-5 Adverse Events|Adverse events were characterized using Common Terminology Criteria for Adverse Events (CTCAE)|Up to week 13||||Participants|||Count of Participants
2565778|NCT02590003|Secondary|Overall Survival||Up to 12 months|The study was terminated after only 3 patients were randomized and all 3 did not respond to treatment.|||Participants|||Count of Participants
2565779|NCT02590003|Secondary|Progression-free Survival||start of treatment to disease progression, up to 12 months|The study was terminated after only 3 patients were randomized and all 3 did not respond to treatment.|||Participants|||Count of Participants
2565780|NCT02590003|Secondary|Overall Response Rate||start of treatment to disease progression/recurrence, up to 12 months|The study was terminated after only 3 patients were randomized and all 3 did not respond to treatment.|||Participants|||Count of Participants
2565781|NCT02590003|Primary|Treatment Failure-free Survival||90 days||||Participants|||Count of Participants
2565782|NCT02589808|Primary|Number of Participants With Same Results With GE VScan and Full Transthoracic Echocardiogram|Number of participants who had the same results with both diagnostic device (GE VScan and full transthoracic echocardiogram)|30min||||Participants|||Count of Participants
2565783|NCT02589639|Secondary|Percentage of Patients With Investigator Defined Drug−Related Adverse Events (AEs)|Percentage of patients with investigator defined drug−related Adverse Events (AEs) are presented|From 1st intake of study drug to last intake of study drug + 7 days; up to 53 weeks|Treated set (TS): TS consisted of all randomised patients who were treated with at least 1 dose of the study drug during the 52-week double blind treatment period. The TS was the basis for safety analyses.|||Percentage of participants|||Number
2565784|NCT02589639|Primary|Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) After 16 Weeks of Treatment.|"The primary endpoint was the change from baseline in HbA1c after 16 weeks of treatment.~The term baseline refers to the last observation prior to the administration of any randomised study drug.~Means presented are the adjusted means."|Baseline and 16 weeks|Full analysis set (FAS) with last observation carried forward at 16 weeks (LOCF)-16; The FAS consisted of all patients in the TS who had a baseline measurement of the primary endpoint.|||percentage of HbA1c||Standard Error|Mean
2565785|NCT02589626|Secondary|Change From Baseline in HbA1c After 52 Weeks of Treatment|Change from baseline in HbA1c after 52 weeks of treatment is presented. Means presented are the adjusted means.|baseline and 52 weeks|Full Analysis Set (Observed cases (OC))|||% of HbA1c||Standard Deviation|Mean
2565786|NCT02589626|Primary|Percentage of Patients With Drug-related Adverse Events (AEs) During 52 Weeks of Treatment|Percentage of patients with drug-related Adverse events (AEs) during 52 weeks of treatment are presented|52 weeks|The treated set (TS) consisted of all patients who were randomised and treated with at least 1 dose of the study drug. The assignment of patients to treatment group was based on the first study drug intake in the double-blind treatment period.|||Percentage of participants|||Number
2565787|NCT02589405|Primary|Number of Participants Satisfied and Very Satisfied With Regimen|Number of subjects satisfied and very satisfied with the three-part treatment regimen|12 weeks|Only Data Observed: All subjects that answered this question (which explains the discrepancy with the total number of participants) -|||participants|||Number
2565788|NCT02589171|Secondary|Hospital Stay Duration||from the the time of hospital admission to the time of hospital discharge (about 1.29 to 2.95 days)||||days||Standard Deviation|Mean
2565801|NCT02589171|Primary|Technical Effectiveness as Assessed by Depth of Needle Penetration to Complete Closure at Both the Camera Port Site and Stapler Port Site||at the time of surgery|Data were not available for 12 participants in the NeoClose arm and 16 participants in the Carter Thomason arm. For each participant analyzed, there were needle depth data available for 1, 2, 3, or 4 stitches per participant.|||centimeters|stitch|Standard Deviation|Mean
2565802|NCT02589171|Primary|Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Stapler Port Site||at the time of surgery|Data were not available for 3 in the Carter Thomason arm.|||seconds||Standard Deviation|Mean
2565803|NCT02589171|Primary|Technical Effectiveness as Assessed by the Time Required to Complete Closure at the Camera Port Site||at the time of surgery|Data were not available for 1 in the Carter Thomason arm.|||seconds||Standard Deviation|Mean
2565804|NCT02589171|Primary|Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Stapler Port Site||at the time of surgery|Data were not available for 5 in the NeoClose arm and 6 in the Carter Thomason arm.|||number of sutures||Standard Deviation|Mean
2565805|NCT02589171|Primary|Technical Effectiveness as Assessed by Number of Sutures Required to Complete Closure at the Camera Port Site||at the time of surgery|Data were not available for 4 in the NeoClose arm and 3 in the Carter Thomason arm.|||number of sutures||Standard Deviation|Mean
2565806|NCT02589145|Secondary|Pharmacodynamic Studies|Evaluated IRF4, SPIB, STAT1, p-STAT1, CARD11, I-kappa-Kinase-beta and p-I-kappa-Kinase-beta in PBMNC pre- and post-treatment (at baseline and on day -1).|Up to 2 years post transplant|Due to low accrual, the pharmacodynamic studies could not be determined for this outcome.||||||
2565807|NCT02589145|Secondary|Toxicity Profile|Determined the toxicity profile|Up to 2 years post transplant|Due to low accrual, the Toxicity profile could not be determined for this outcome.||||||
2565808|NCT02589145|Secondary|Overall Remission Rate (ORR)|Determined overall remission rate (ORR) rate|Up to 2 years post transplant|Due to low accrual, the ORR could not be determined for this outcome.||||||
2565809|NCT02589145|Secondary|Complete Remission (CR) Rate|Determined complete remission (CR) rate|Up to 2 years post transplant|Due to low accrual, CR rate could not be determined for this outcome.||||||
2565810|NCT02589145|Secondary|Overall Survival (OS)|Assessed the 2-year overall survival (OS)|Up to 2 years post transplant|Due to low accrual, OS could not be determined for this outcome.||||||
2565811|NCT02589145|Primary|Event-free Survival (EFS)|Determined the 2-year event-free survival (EFS)|Up to 2 years post transplant|Due to low accrual, EFS could not be determined for this outcome.||||||
2565812|NCT02589145|Primary|Maximum Tolerated Dose (MTD)|Established the maximum tolerated dose (MTD) of lenalidomide combined with vorinostat/gemcitabine/busulfan/melphalan with autologous stem-cell transplant ASCT). Maximum tolerated dose (MTD) of lenalidomide based on DLT was defined as any Grade 4 or 5 nonhematologic, noninfectious toxicity or any grade 3 mucositis or skin toxicity lasting > 5 days at their peak severity. Lenalidomide doses were chosen adaptively for successive cohorts with a minimum size of 2 patients. Toxicity scoring followed the National Cancer Institute Common Toxicity Criteria, version 4.|Enrollment up to day 30 post transplant for each dosing cohort|Due to low accrual, MTD could not be determined for this outcome.||||||
2565813|NCT02588976|Secondary|Glass Bead Activated Clotting Time||Routine measurements during cardiac surgery||||seconds||Standard Deviation|Mean
2565814|NCT02588976|Primary|Kaolin-activated Clotting Time||Routine measurements during cardiac surgery||||seconds||Standard Deviation|Mean
2565815|NCT02588872|Secondary|Biologic Testing of Synovial Fluid Via ELISA Assays|ELISA analysis will be performed for the following biological markers: IL-1β, IL-1ra, IL-6, IL-8, TNFα|Primary outcome will be change from pre-treatment to 6-month post treatment.|IL-1B|||units on a scale||Standard Error|Mean
2565816|NCT02588872|Secondary|Lysholm Knee Score|This is a scale from 1-100, 100 being high function and 1 being very poor function that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.|This will be assessed as a change from pre-treatment visit to 1 year post treatment.||||units on a scale||Standard Error|Mean
2565817|NCT02588872|Secondary|Western Ontario and McMaster Universities Arthritis Index|This is a scale from 1-100, 100 being high function and 1 being very poor function that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.|This will be assessed as a change from pre-treatment visit to 1 year post treatment. 6-weeks post-treatment, 6-months post treatment, and finally at 1-year post treatment will be documented for the purpose of trending data.||||units on a scale||Standard Error|Mean
2565818|NCT02588872|Secondary|Visual Analogue Scale (VAS)|This is a scale from 1-100, 100 being the worst pain imaginable and 1 being no pain at all that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.|This will be assessed as a change from pre-treatment visit to 1 year post treatment.||||units on a scale||Standard Error|Mean
2565819|NCT02588872|Primary|International Knee Documentation Committee Score (IKDC|This is a scale from 1-100, 100 being high function and 1 being very poor function that will be assessed via paper questionnaire at the delineated time intervals. The Primary outcome assessed will be at an average of 1-year post treatment.|This will be assessed as a change from pre-treatment visit to 1 year post treatment.|9 HA patients and 3 PRP from the original cohort were lost to follow up which is why 50 HA and 49 PRP patients were included in final analysis.|||units on a scale||Standard Error|Mean
2565820|NCT02588599|Secondary|Change in Millimeters (mm) of Clear Nail Bed|Millimeter (mm) of clear nail from the base of the toenail was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 6 months after the end of the procedure administration phase. An increase in mm of clear nail between the two measurement points indicates that the toenail has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail has worsened and is negative for study success.|Baseline and 6 Months|Each participant in this study had only one great toenail treated.|||millimeters|Participants|Standard Deviation|Mean
2566441|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Alanine Aminotransferase (U/L)||Baseline, Week 24|Participants with measurements at given time point.|||U/L||Standard Deviation|Mean
2565821|NCT02588599|Primary|Percent (%) of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth|Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 6 months post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria.|6 Months|Each participant had only one great toenail treated in this study.|||Percent of Toenails|Participants||Number
2565822|NCT02588573|Primary|Visual Acuity|High contrast visual acuity at high illumination was measured with each lens at each visit using a logMAR chart.|Baseline and 8 hours||||LogMAR|eyes|Standard Deviation|Mean
2565823|NCT02588573|Primary|Conjunctival Staining|"Conjunctival staining was graded in each quadrant with scale 0-4, 0.5 steps, 0=normal, 4=severe of four areas:~N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central"|8 hours||||units on a scale|eyes|Standard Deviation|Mean
2565824|NCT02588573|Primary|Limbal Hyperemia|Limbal hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.|Baseline and 8 hours||||units on a scale|eyes|Standard Deviation|Mean
2565825|NCT02588573|Primary|Bulbar Hyperemia|Bulbar hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.|Baseline and 8 hours||||units on a scale|eyes|Standard Deviation|Mean
2565826|NCT02588573|Primary|Comfort Preference|Lens preference in regards to comfort of etafilcon A and somofilcon A. Categories: Strongly prefer etafilcon A lens, slightly prefer etafilcon A lens, no preference, slightly prefer somofilcon A lens, strongly prefer somofilcon A lens|Baseline and 8 hours||||participants|||Number
2565827|NCT02588573|Primary|Comfort|Subjective ratings for lens comfort of etafilcon A and somofilcon A. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever.|8 hours||||units on a scale|eyes|Standard Deviation|Mean
2565828|NCT02588339|Secondary|Percentage of Participants With Relapse-free Survival (RFS)|Relapse-free survival: Time from transplant date to death or primary disease relapse. Time-to-event data such as relapse-free survival is measured from the date of transplantation. RFS will be analyzed using the Kaplan-Meier method.|1 year||||percentage of participants|||Number
2565829|NCT02588339|Secondary|Percentage of Participants With Overall Survival (OS)|Overall survival: Time from transplant date to death from any cause. Time-to-event data such as overall survival is measured from the date of transplantation. OS will be analyzed using the Kaplan-Meier method.|1 year||||percentage of participants|||Number
2565830|NCT02588339|Secondary|Number of Participants With Non-relapse Mortality|Incidence of primary disease relapse and non-relapse related death will be reported per standard definitions. These will be treated as competing risk events. Non-relapse death is defined as death in continuous remission from primary disease requiring transplantation.|1 year||||Participants|||Count of Participants
2565831|NCT02588339|Secondary|Number of Participants With Primary Disease Relapse|Incidence of primary disease relapse and non-relapse related death will be reported per standard definitions. These will be treated as competing risk events.|1 year||||Participants|||Count of Participants
2565832|NCT02588339|Secondary|Time to Stable Engraftment|Stable engraftment for white blood count (WBC) is defined as a sustained absolute neutrophil count > 500 over 3 days without cytokine support. Stable platelet engraftments is defined as count of > 20,000 over 7 days without transfusion support. Time to engraftment is defined as time from day 0 to day of sustained engraftment per above criteria for both platelets and WBC.|100 days post transplant|Participants with stable engraftment were analyzed|||days||95% Confidence Interval|Median
2565833|NCT02588339|Secondary|Number of Participants Stratified by Chronic Graft Versus Host Disease (GVHD) Stage|GVHD with onset after 100 days post-HCT with presence of at least one diagnostic manifestation of chronic c-GVHD or distinct manifestation confirmed by biopsy or other relevant tests (e.g., PFT). Classified as: 1- Classic chronic GVHD - meets criteria for chronic GVHD and has no features consistent with aGVHD or 2-Overlap syndrome - features of acute and chronic GVHD exist together. C-GVHD will be measured prospectively in all participants on days 90+/-14 , 120 +/- 14, 150 +/- 14, 180+/- 14, 270+/- 30, and 365 +/- 30 as per standardized scoring system.|100 days post transplant||||Participants|||Count of Participants
2565834|NCT02588339|Primary|Number of Participants Stratified by Acute Graft Versus Host Disease GVHD Stage|Cumulative incidence of acute GVHD grades II-IV by day 100. Investigators will consider ≥43% incidence of grade II-IV aGVHD not acceptable. Investigators will use 23% incidence rate of GVHD as target. GVHD severity stage and grading and distribution will be measured weekly from day of transplant to day 90 +/- 14 using standard scoring system. Stage of GVHD will be given for each site of involvement (e.g. skin, liver, and gut), as well as a composite score for overall acute GVHD grade. Pathologic confirmation of aGVHD will be dictated by usual clinical practice, and not mandated by this protocol.|100 days post transplant||||Participants|||Count of Participants
2565835|NCT02588261|Secondary|EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)|The EQ-5D is a generic preference-based measure that indirectly measures the utility for health that generates an index-based summary score based upon societal preference weights. The EQ-5D-5L consists of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale (VAS) for health status. Each item has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). The VAS ranges from 0 (worst health status) and 100 (best health status).|Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)|The analysis population was the SAF, with available data.|||Units on a scale||Standard Deviation|Mean
2565836|NCT02588261|Secondary|European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30)|EORTC-QLQ-LC30 is a 30-item cancer-specific questionnaire with multitrait scaling was used to create five functional domain scales: Physical, Role, Emotional, Social and Cognitive; two items evaluate global QoL; in addition, three symptom scales assess Fatigue, Pain and Emesis; and six single items assess other symptoms. The total score ranges from 0 to 100, with a high score for a functional scale representing a high/healthy level of functioning and a high score for a symptom scale or item representing a high level of symptomatology or problems.|Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)|The analysis population was the SAF, with available data.|||units on a scale||Standard Deviation|Mean
2566245|NCT02582814|Primary|Hypoglycemia|To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.|From baseline to 52 weeks||||Participants|||Count of Participants
2565837|NCT02588261|Secondary|European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 (EORTC-QLQ-LC13)|The EORTC-QLQ-LC13 is a validated module of the EORTC-QLQ-Core 30, which includes module items that evaluate symptoms such as cough, hemoptysis, shortness of breath, sore mouth or tongue, dysphagia, tingling hands or feet, hair loss and pain. The total score for the questionnaire ranges from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.|Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)|The analysis population was the SAF, with available data.|||units on a scale||Standard Deviation|Mean
2565838|NCT02588261|Secondary|Functional Assessment of Cancer Therapy - EGFR Inhibitors Subscale (FACT-EGFRI-18) Questionnaire|"ACT-EGFRI-18 is an 18-item Likert-scaled questionnaire, used to assess the effect of EGFR inhibitors on quality of life (QoL). The questionnaire is arranged in three HRQL dimensions: physical (seven items), social/emotional (six items), and functional well-being (five items). The response scores ranged from 0 to 4, and the response categories include not at all, a little bit, somewhat, quite a bit, and very much. Negatively worded items (e.g., My skin bleeds easily or My skin condition affects my mood) are reverse-scored, so that participants who experience a higher impact of symptom burden on HRQL receive a lower score (range 0-72)."|Day 1 of each cycle up to data cut off 09 May 2017 (approximately 15 months)|The analysis population was the SAF, with available data.|||units on a scale||Standard Deviation|Mean
2565839|NCT02588261|Secondary|Number of Participants With Adverse Events (AEs)|Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A treatment-emergent AE (TEAE) was defined as an AE observed after starting administration of the study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization.|From first dose of study drug up to 30 days after last dose of study drug taken up to data cut-off 09 May 2017|The analysis population was SAF.|||participants|||Number
2565840|NCT02588261|Secondary|Duration of Response (DOR)|DOR was defined as the time from the date of the first response CR/PR (whichever was first recorded) as assessed by IRR to the date of radiographical progression or date of censoring. If a participant had not progressed, the participant was censored at the date of last radiological assessment or at the date of first CR/PR if no post-baseline radiological assessment was available. Results are based Kaplan-Meier estimate.|From date of first response up to data cut-off date 09 May 2017 (approximately 15 months)|The analysis population was the FAS. Only participants with best overall response as CR or PR (without confirmation) were included in the analysis.|||months||95% Confidence Interval|Median
2565841|NCT02588261|Secondary|Percentage of Participants With Disease Control|Percentage of participants with disease control was defined as the proportion of participants whose best overall response was rated as CR, PR or stable disease (SD) among all analyzed participants based on RECIST V1.1. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters. SD was defined as neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum of diameters while on study drug.|From date of first dose of study drug up to data cut-off date 09 May 2017 (approximately 15 months)|The analysis population was the FAS.|||percentage of participants||95% Confidence Interval|Number
2565842|NCT02588261|Secondary|PFS as Assessed by the Investigator|PFS was defined as the time from the date of randomization until the date of radiological disease progression or until death due to any cause, based on RECIST V1.1, as assessed by local investigator. Results are based Kaplan-Meier estimate. If a participant had neither progressed nor died, who received any further anticancer therapy for the disease before radiological progression, the participant was censored at the date of last radiological assessment. If progression or death occurred after missing 2 scheduled radiological assessments, the participant was censored at the date of last radiological assessment or at the date of randomization if no post-baseline radiological assessment was available.|From date of randomization up to data cut-off date 09 May 2017 (approximately 15 months)|The analysis population was the FAS.|||months||95% Confidence Interval|Median
2565843|NCT02588261|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR was defined as the proportion of participants with best overall response as complete response (CR) or partial response (PR) without confirmation based on the RECIST v1.1 as assessed by the blinded IRR. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to < 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters.|From date of first dose of study drug up to data cut-off date 09 May 2017 (approximately 15 months)|The analysis population was the FAS.|||percentage of participants||95% Confidence Interval|Number
2565844|NCT02588261|Secondary|Percentage of Deaths|All events of death after the first study drug administration were included.|From date of randomization up to data cut-off date 21 Dec 2017 (approximately 22 months)|The analysis population was the safety analysis set (SAF), which consisted of all participants who took at least one dose of study drug.|||percentage of participants|||Number
2565857|NCT02588092|Secondary|Accumulation Index (AI) for ADCT-301 for the QW Dosing Schedule|AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort. AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 7 days divided by AUC from 7 to 14 days for Cycle 1.|Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2565845|NCT02588261|Primary|Progression Free Survival (PFS) as Assessed by Independent Radiologic Review (IRR)|PFS was defined as the time from the date of randomization until the date of radiological disease progression or until death due to any cause, based on the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by IRR. Results are based Kaplan-Meier estimate. If a participant had neither progressed nor died, who received any further anticancer therapy for the disease before radiological progression, the participant was censored at the date of last radiological assessment. If progression or death occurred after missing 2 scheduled radiological assessments, the participant was censored at the date of last radiological assessment or at the date of randomization if no post-baseline radiological assessment was available.|From date of randomization up to data cut-off date 09 May 2017 (approximately 15 months)|The analysis population was the full analysis set (FAS), which consisted of all participants who were randomized.|||months||95% Confidence Interval|Median
2565846|NCT02588092|Secondary|Number of Participants With Anti-drug Antibody Response (Against ADCT-301)|Blood serum samples were collected and analysed to determine the presence or absence of ADA. Results were pooled for Part 1 participants as specified in the protocol.|Day 1 to the end of Cycle 2 (6 weeks)||||Participants|||Count of Participants
2565847|NCT02588092|Secondary|Clearance (CL) for ADCT-301 for the QW Dosing Schedule|CL for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.|Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed.|||L/day||Geometric Coefficient of Variation|Geometric Mean
2565848|NCT02588092|Secondary|Clearance (CL) for ADCT-301 for the Q3W Dosing Schedule|CL for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.|Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed.|||L/day||Geometric Coefficient of Variation|Geometric Mean
2565849|NCT02588092|Secondary|Apparent Terminal Phase Elimination Half-life (Thalf) for ADCT-301 for the QW Dosing Schedule|Thalf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.|Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed.|||days||Geometric Coefficient of Variation|Geometric Mean
2565850|NCT02588092|Secondary|Apparent Terminal Phase Elimination Half-life (Thalf) for ADCT-301 for the Q3W Dosing Schedule|Thalf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.|Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed.|||days||Geometric Coefficient of Variation|Geometric Mean
2565851|NCT02588092|Secondary|Terminal Elimination Phase Rate Constant (λz) for ADCT-301 for the QW Dosing Schedule|λz analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.|Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)|This analysis was planned, but data was not collected as the study was terminated prematurely.||||||
2565852|NCT02588092|Secondary|Terminal Elimination Phase Rate Constant (λz) for ADCT-301 for the Q3W Dosing Schedule|λz analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.|Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)|This analysis was planned, but data was not collected as the study was terminated prematurely.||||||
2565853|NCT02588092|Secondary|Mean Residence Time (MRT) for ADCT-301 for the QW Dosing Schedule|MRT analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.|Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)|This analysis was planned, but data was not collected as the study was terminated prematurely.||||||
2565854|NCT02588092|Secondary|Mean Residence Time (MRT) for ADCT-301 for the Q3W Dosing Schedule|MRT analysis was planned for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.|Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)|This analysis was planned, but data was not collected as the study was terminated prematurely.||||||
2565855|NCT02588092|Secondary|Volume of Distribution at Steady-state (Vss) for ADCT-301 for the QW Dosing Schedule|Vss for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.|Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed.|||liters||Geometric Coefficient of Variation|Geometric Mean
2565856|NCT02588092|Secondary|Volume of Distribution at Steady-state (Vss) for ADCT-301 for the Q3W Dosing Schedule|Vss for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.|Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed.|||liters||Geometric Coefficient of Variation|Geometric Mean
2565858|NCT02588092|Secondary|Accumulation Index (AI) for ADCT-301 for the Q3W Dosing Schedule|AI for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort. AI is the ratio of area under the serum concentration-time curve (AUC) from 0 to 21 days for Cycle 2 divided by AUC from 0 to 21 days for Cycle 1.|Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2565859|NCT02588092|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for ADCT-301 for the QW Dosing Schedule|AUCinf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.|Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed.|||day*μg/L||Geometric Coefficient of Variation|Geometric Mean
2565860|NCT02588092|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for ADCT-301 for the Q3W Dosing Schedule|AUCinf for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.|Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed.|||day*μg/L||Geometric Coefficient of Variation|Geometric Mean
2565861|NCT02588092|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUCtau) for ADCT-301 for the QW Dosing Schedule|AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.|Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)|The analysis was planned, but the data was not collected as study was terminated prematurely.||||||
2565862|NCT02588092|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to the End of the Dosing Interval (AUCtau) for ADCT-301 for the Q3W Dosing Schedule|AUCtau for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.|Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed.|||day*μg/L||Geometric Coefficient of Variation|Geometric Mean
2565863|NCT02588092|Secondary|Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-301 for the QW Dosing Schedule|AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.|Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed.|||day*μg/L||Geometric Coefficient of Variation|Geometric Mean
2565864|NCT02588092|Secondary|Area Under the Serum Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for ADCT-301 for the Q3W Dosing Schedule|AUClast for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.|Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed.|||day*μg/L||Geometric Coefficient of Variation|Geometric Mean
2565865|NCT02588092|Secondary|Time to Reach the Maximum Observed Serum Concentration (Tmax) for ADCT-301 for the QW Dosing Schedule|Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.|Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed.|||days||Geometric Coefficient of Variation|Geometric Mean
2565866|NCT02588092|Secondary|Time to Reach the Maximum Observed Serum Concentration (Tmax) for ADCT-301 for the Q3W Dosing Schedule|Tmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohort.|Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed.|||days||Geometric Coefficient of Variation|Geometric Mean
2565867|NCT02588092|Secondary|Maximum Observed Serum Concentration (Cmax) of ADCT-301 for the QW Dosing Schedule|Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for QW cohort.|Before infusion, end of infusion, 5, 24, 48, and 96 hours after infusion on days 1 and 8, and before and after infusion on Day 15 of Cycle 1 and 2 (1 cycle = 21 days)|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed.|||μg/L||Geometric Coefficient of Variation|Geometric Mean
2565909|NCT02586974|Primary|Intraoperative Change in Body Core Temperature|body core temperature of patients undergoing robot-assisted radical prostatectomy (RARP), measured with a disposable esophageal probe|Intraoperative at hourly intervals||||degrees °C||Standard Deviation|Mean
2566442|NCT02581202|Secondary|Absolute Values and Change From Baseline in Anthropometric Measurements At Week 48||Baseline, Week 48|Participants with measurements at given time point.|||cm||Standard Deviation|Mean
2565868|NCT02588092|Secondary|Maximum Observed Serum Concentration (Cmax) of ADCT-301 for the Q3W Dosing Schedule|Cmax for Pyrrolobenzodiazepine (PBD) conjugated antibody (Ab), total Ab and free warhead (SG3199) for Q3W cohorts.|Before infusion, end of infusion, 1, 3, 6, 24, 48, and 96 hours after infusion, and on Days 8 and 19 of Cycle 1 and 2 (1 cycle = 21 days)|Only participants with evaluable pharmacokinetic results were included in the analysis. Where data is not presented, the pharmacokinetic profiles were nonmeasurable or short-lived in duration; therefore, no analysis could be performed.|||μg/L||Geometric Coefficient of Variation|Geometric Mean
2565869|NCT02588092|Secondary|Number of Participants With Progression Free Survival (PFS)|PFS is defined as the time from first dose of study drug until the first date of either disease progression or death due to any cause. A summary of antitumor activity was not conducted due to a limited number of responders.|Screening, Day 19 visit (+/- 3 days) of Cycle 2 and each subsequent cycle up to 12 months after the last dose of study drug (1 cycle = 21 days)|The analysis was planned, but the data was not collected as study was terminated prematurely.||||||
2565870|NCT02588092|Secondary|Overall Survival (OS)|OS is defined as the time from the first dose of study drug treatment until the date of death due to any cause. A summary of antitumor activity was not conducted due to a limited number of responders.|Screening, Day 19 visit (+/- 3 days) of Cycle 2 and each subsequent cycle up to 12 months after the last dose of study drug (1 cycle = 21 days)|The analysis was planned, but the data was not collected as study was terminated prematurely.||||||
2565871|NCT02588092|Secondary|Overall Response Rate (ORR)|ORR is defined as the percentage of participants with a best overall response of CR, CRi, or PR at the time each participant discontinues treatment with ADCT-301. A summary of antitumor activity was not conducted due to a limited number of responders.|Screening, Day 19 visit (+/- 3 days) of Cycle 2 and each subsequent cycle up to 12 months after the last dose of study drug (1 cycle = 21 days)|The analysis was planned, but the data was not collected as study was terminated prematurely.||||||
2565872|NCT02588092|Secondary|Duration of Response (DOR)|"DOR is defined among responders (complete response [CR], CR with incomplete blood count recover [CRi], or partial response [PR]) as the time from the earliest date of first response until the first date of either disease progression or death due to any cause. A summary of antitumor activity was not conducted due to a limited number of responders.~CR:~Bone marrow differential showing ≤5% blast cells.~Absolute neutrophil count (ANC) ≥1.0 x 10^9/L and platelet count ≥100 x 10^9/L.~Absence of extramedullary disease.~Participant is independent of red blood cell transfusions.~CRi is defined as achieving all CR criteria except that values for ANC may be <1.0 x 10^9/L and/or values for platelets may be <100 x 10^9/L.~PR:~ANC ≥1.0 x 10^9/L and platelet count ≥100 x 10^9/L.~Bone marrow differential showing a ≥50% decrease from baseline in the percentage of bone marrow blast cells to a level >5% and ≤25%, or bone marrow differential showing <5% blast cells."|Screening, Day 19 visit (+/- 3 days) of Cycle 2 and each subsequent cycle up to 12 months after the last dose of study drug (1 cycle = 21 days)|The analysis was planned, but the data was not collected as study was terminated prematurely.||||||
2565873|NCT02588092|Primary|Number of Participants Reporting One or More Treatment Emergent Serious Adverse Event (SAE)|An SAE is defined as any event that results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Hospitalization for elective procedures or for protocol compliance is not considered an SAE.|Day 1 to a maximum of 24 weeks (+ 30 days)||||Participants|||Count of Participants
2565874|NCT02588092|Primary|Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs)|A TEAE is defined as any adverse event not present before exposure to study drug or any event already present that worsens in either intensity or frequency after exposure to study drug.|Day 1 to a maximum of 24 weeks (+ 30 days)||||Participants|||Count of Participants
2565875|NCT02588092|Primary|Recommended Dose of ADCT-301 for Part 2|The recommended dose was to be established by the dose escalation steering committee and based on safety findings during part 1 of the study.|Day 1 to Day 21 (Cycle 1)|The analysis was planned, but the data was not collected as study was terminated prematurely.||||||
2565876|NCT02588092|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities (DLT)|"A DLT is defined as any of the following events, except those that are clearly due to underlying disease or extraneous causes:~A hematologic DLT is defined as:~- Grade 3 or higher event of neutropenia or thrombocytopenia, or a Grade 4 anemia, with a hypocellular bone marrow lasting for 6 weeks or more after the start of a cycle, in the absence of residual leukemia (i.e., with <5% blasts). In case of a normocellular bone marrow with <5% blasts, 8 weeks with ≥Grade 3 pancytopenia will be considered a DLT.~A non-hematologic DLT is defined as:~Grade 4 tumor lysis syndrome.~Grade 3 or higher AE (including nausea, vomiting, diarrhea, and electrolyte imbalances lasting more than 48 hours despite optimal therapy; excluding all grades of alopecia).~CTCAE Grade 3 or higher hypersensitivity reaction (regardless of premedication).~CTCAE Grade 3 or higher skin ulceration.~Peripheral sensory or motor neuropathy ≥ Grade 2."|Day 1 to Day 21 (Cycle 1)||||Participants|||Count of Participants
2565877|NCT02587819|Post-Hoc|Change in Lesion Size.|BCC lesion area was measured at Baseline and after 28 days treatment. Percantage change in lesion area was caculated.|28 days|Final area of lesion was not recorded for one subject.|||percentage change in tumour area||Standard Error|Mean
2565878|NCT02587819|Primary|Pharmacokinetics - Measure Subject Antibody Response to the Active Pharmaceutical Ingredient Using an Indirect Fluorescent Immuno Assay.|The active ingredient of BSCT is sheep IgG which may causes an immunogenic response if it enters the systemic circulation. To monitor this response patient blood samples collected at Screening, Visit 2 (Baseline), Visit 6 (EOT), and at Visit 8 (EOS) was tested for anti-sheep IgG antibodies (indicative of immune response against API).|8 weeks|Anti sheep IgG antibody titres were measured from 21 subjects at screening and baseline, 20 subjects at Visit 6 (Day 29 EOT) and 19 subjects at Visit 8 (Day 57 follow up). The percentage of patients with detectable anti sheep antibodies is reported.|||percentage of subjects|||Number
2565910|NCT02586909|Primary|Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments|The primary outcome measure is to study the safety of Intepridine (RVT-101) by determining the incidence of AEs, changes in physical examinations, vital signs measurements, ECGs and clinical laboratory assessments|Baseline to 12 months or Early Termination||||Participants|||Count of Participants
2565879|NCT02587819|Primary|Pharmacokinetics - Measure Serum Concentration of Total Sheep IgG Using an ELISA.|To determine PK, blood levels of sheep IgG were measured in samples collected at Visit 2 (Baseline), Visit 5, predose at Visit 6 (EOT), and then at 1 h, 2 h, and 4 h after the last dose of study medication.|28 days|At all timepoints, the serum concentration of sheep IgG was too low to be quantified in most of the subjects. One subject had measurable sheep IgG at 1 hr post dose at Visit 6 (EOT) and 3 other subjects had measurable sheep IgG at predose timepoints. In outcome measure below NA represents readings less than lower limit of quantification.|||ng/ml||Full Range|Median
2565880|NCT02587819|Primary|Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)|Adverse events and any changes in physical examinations will be monitored, as described in the Code of Federal Regulations (CFR) Title 21 Part 312. In particular local cutaneous irritation including erythema, peeling, dryness, itching, and burning/ stinging that first occur during the study or represent a worsening from Baseline will be recorded as AEs.|8 weeks|All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments was at 57 days post-Baseline.|||participants|||Number
2565881|NCT02587650|Secondary|Evaluation of the Adverse Effect Profile of Each Kinase Inhibitor|Frequencies of toxicities will be tabulated according to CTCAE v4.03 to assess drug safety and tolerability|Up to 2 years|Evaluable patients would be those with baseline staging, treatment for at least 8 weeks, and at least one post-baseline staging scan while on treatment. No participants meet the criteria to be considered evaluable for this analysis.||||||
2565882|NCT02587650|Secondary|Progression Free Survival|Progression free survival (PFS) defined as the time from treatment start to the progression or death and overall survival defined as the time from treatment start to death will be estimated using Kaplan-Meier methodology|up to 2 years|Evaluable patients would be those with baseline staging, treatment for at least 8 weeks, and at least one post-baseline staging scan while on treatment. No participants meet the criteria to be considered evaluable for this analysis.||||||
2565883|NCT02587650|Secondary|Overall Survival|Overall defined as the time from treatment start to the progression or death and overall survival defined as the time from treatment start to death will be estimated using Kaplan-Meier methodology.|From treatment start to death, assessed up to 2 years|Evaluable patients would be those with baseline staging, treatment for at least 8 weeks, and at least one post-baseline staging scan while on treatment. No participants meet the criteria to be considered evaluable for this analysis.||||||
2565884|NCT02587650|Secondary|Clinical Benefit Rate (CBR)|Clinical benefit rate is defined as the proportion of patients achieving a complete response (CR) or partial response (PR) or stable disease (SD) for > 24 weeks using the same RECIST 1.1 decision matrix used to calculate ORR. The CBR will be estimated for each arm along with a 95% confidence interval|Up to 2 years|Evaluable patients would be those with baseline staging, treatment for at least 8 weeks, and at least one post-baseline staging scan while on treatment. No participants meet the criteria to be considered evaluable for this analysis.||||||
2565885|NCT02587650|Primary|Confirmed Overall Response Rate (ORR)|Defined as a complete or partial response as per Response Evaluation Criteria in Solid Tumors version 1.1 criteria with confirmatory measurements a minimum of 4 weeks after the response-defining determination. Analysis of study results will include ORR estimations of ALK, NTRK, ROS1, RET, MET, and BRAF rearrangement-positive patients.|24 weeks|Evaluable participants would be those with baseline staging, treatment for at least 8 weeks, and at least one post-baseline staging scan while on treatment. No participants meet the criteria to be considered evaluable for this analysis.||||||
2565886|NCT02587520|Primary|Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged >=65 Years|An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR is therefore an ADR observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.|Within 7 days after vaccination|"Analysis was performed on safety analysis set. Here, number analyzed=number of participants with available data for each specified category."|||Participants|||Count of Participants
2565887|NCT02587520|Primary|Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 19-64 Years|An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR is therefore an ADR observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.|Within 7 days after vaccination|"Analysis was performed on safety analysis set. Here, number analyzed=number of participants with available data for each specified category."|||Participants|||Count of Participants
2565888|NCT02587520|Primary|Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years|A solicited reaction (SR) is an adverse event (AE) that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. An SR is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature & onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and solicited systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.|Within 7 days after vaccination|"Safety analysis set that was defined as those participants who had received study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Here, number analyzed= number of participants with available data for each specified category."|||Participants|||Count of Participants
2566443|NCT02581202|Secondary|Absolute Values and Change From Baseline in Anthropometric Measurements At Week 24||Baseline, Week 24|Participants with measurements at given time point.|||cm||Standard Deviation|Mean
2565889|NCT02587234|Secondary|Change in Action Research Arm Test (ARAT)|"Values given are score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline.~The ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement).~Performance on each item is rated on a 4-point ordinal scale ranging from:~3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty~1: Performs test partially 0: Can perform no part of test The maximum score on the ARTS is 57 points (possible range 0 to 57)."|baseline, post-intervention, 1-month follow-up|Two subjects from the Sham PNS group were lost to follow-up.|||units on a scale||95% Confidence Interval|Mean
2565890|NCT02587234|Secondary|Change in Fugl Meyer Assessment Motor Score|Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline. The scores can range from 0 to 66, with higher scores indicating better performance. The scores are calculated by summing the scores to the 33 individual tasks.|baseline, post-intervention, 1-month follow-up|Two subjects from the Sham PNS group were lost to follow-up.|||units on a scale||95% Confidence Interval|Mean
2565891|NCT02587234|Primary|Change in Wolf Motor Function Test (WMFT), Timed Portion|Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline|baseline, post-intervention, 1-month follow-up|Two subjects in the Sham PNS group were lost to follow-up.|||log(seconds)||95% Confidence Interval|Mean
2565892|NCT02587143|Primary|Pain Level on the Visual Analog Scale (NRS-11)|patients will measure their pain score on a visual analog scale (NRS-11: Numeric Rate Score, from 0 -no pain- to 10 points -the worst pain ever-) after the puncture|scores on a scale immediately after the puncture||||scores on scale||Inter-Quartile Range|Median
2565893|NCT02587117|Secondary|Burning Sensation or Pain by Using NRS (Numerical Rating Scale)|Standard self-response Numerical Rating Scale (NRS) of 0 (no oral discomfort) to 10 (worst imaginable oral discomfort) to represent the intensity of burning sensation or pain or discomfort. The mean of NRS burning sensation score was calculated after eight weeks of treatment and considered as 8th week NRS burning sensation score.|8 weeks minus baseline||||Scores on a scale||Standard Deviation|Mean
2565894|NCT02587117|Primary|Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score|Reticular: score 0= no white striations; score 1= white striations. Erythematous: score 0= no lesion; score 1= lesion <1 cm2; score 2: lesion 1-3 cm2; score 3= lesion >3 cm2. Ulceration: score 0= no lesion; score 1= lesion <1 cm2; score 2= lesion 1-3 cm2; score 3= lesion >3 cm2. Total weighted score was derived by sum total scores of each lesion and multiplication with weighted score 1.5 & 2.0 in total erythematous and total ulceration scores as ΣR + ΣE × 1.5 + ΣU × 2.0.Total weighted score was dependent on the number of lesions of each participant which was not the same across participants. Higher value of the total score represent worse outcome & zero value represent no lesion.|8 weeks minus baseline||||Scores on a scale||Standard Deviation|Mean
2565895|NCT02587065|Secondary|Number of Participants With Clinical Abnormal Laboratory Values|Participants with clinical abnormal laboratory values were reported throughout the studies.|Baseline up to Week 24|FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time point.|||Participants|||Count of Participants
2565896|NCT02587065|Secondary|Number of Participants With AE Stratified by Severity|Severity of AEs was evaluated based on the following criteria- Mild: Symptoms barely noticeable to participant or does not make participant uncomfortable; does not influence performance or functioning; prescription drug not ordinarily needed for relief of symptom(s) but may be given because of personality of participant. Moderate: Symptoms of a sufficient severity to make participant uncomfortable; performance of daily activity is influenced; participant is able to continue in study; treatment for symptom(s) may be needed. Severe: Symptoms cause severe discomfort; symptoms cause incapacitation or significant impact on participant's daily life; severity may cause cessation of treatment with study treatment; treatment for symptom(s) may be given and/or participant hospitalized.|Baseline up to Week 24|FAS population included all enrolled participants who took at least one dose of the study medication.|||Participants|||Count of Participants
2565897|NCT02587065|Secondary|Number of Participants With Adverse Events (AE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can herefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|Baseline up to Week 24|FAS population included all enrolled participants who took at least one dose of the study medication.|||Participants|||Count of Participants
2565898|NCT02587065|Secondary|Percent Change in Relapse-Free Participants at Week 24|Relapses are defined as neurologic symptoms lasting more than 24 hours which occur at least 30 days after the onset of a preceding event. Percent change in relapse-free participants had been calculated with respect to the number of relapse-free participants at baseline. Here, negative sign indicates decrease in number of relapse free participants at specified timepoint as compared to baseline.|Baseline, Week 24|FAS population included all enrolled participants who took at least one dose of the study medication. Number of participants analyzed are the participants who were evaluable for this outcome measure.|||percentage change|||Number
2565899|NCT02587065|Secondary|Change From Baseline in Annualized Relapse Rate (ARR) at Week 24|Relapses are defined as neurologic symptoms lasting more than 24 hours which occur at least 30 days after the onset of a preceding event. ARR was calculated as the total number of relapses for all participants divided by the total participant-years of exposure to that treatment. Here negative sign indicates decrease in annual relapse rate as compared to baseline.|Baseline, Week 24|FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time point.|||relapses per participant-year|||Number
2565911|NCT02586896|Secondary|Engagement in Participants With Higher Levels of Environmental Instability at Baseline|"Using the same timeframe as initiation, engagement is defined as the number days of medication use for opioid dependence, based on Form 90-D self-report verified by clinic dosing logs and Prescription Drug Monitoring Program records."|3 months||||% days||Standard Error|Mean
2567014|NCT02573012|Secondary|Number of Administrations of Flare Rescue Medication|Proportion of participants who received courses of RA flare rescue medication by number of courses received.|Randomization to 24 weeks||||Percentage of Participants|||Number
2565900|NCT02587065|Secondary|Change From Baseline in Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Week 12 and 24|MusiQoL is a self-administered questionnaire consisting of 31 items describing nine dimensions of health-related quality of life (QoL): activities of daily living, psychological wellbeing, symptoms, relationship with friends, relationship with family, sentimental and sexual life, coping rejection, relationship with healthcare system). All items are scored based on frequency/extent of an event on a five-point scale ranging from never/not at all (option 1) to always/very much (option 5). Total score is obtained by linearly transforming and standardizing on a 0-100 scale. Higher scores indicate a better level of health-related QoL for each dimension and for the global index score. Here, negative values indicate improvement in MusiQoL score from baseline.|Baseline, Weeks 12 and 24|FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time point.|||score on a scale||Standard Deviation|Mean
2565901|NCT02587065|Secondary|Change From Baseline in Adapted Sclerosis Treatment Concerns Questionnaire (MSTCQ) Score at Weeks 12 and 24|MSTCQ is a 20-item questionnaire adapted for 'Peg-interferon Beta 1a' containing two domains: injection system satisfaction (1-9) and side effects (1-11). All questions in the MSTCQ have a five-point response choice, with a minimum possible total score of 20 and a maximum possible total score of 100. Lower total scores indicating better outcomes. Questionnaires were completed electronically by participants, by means of a participant I-PAD at each study visit. Here, negative values indicate improvement in MSTCQ score from baseline.|Baseline, Weeks 12 and 24|FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time point.|||score on a scale||Standard Deviation|Mean
2565902|NCT02587065|Secondary|Change From Baseline in Fatigue Status Scale (FSS) Score at Weeks 12 and 24|FSS is a questionnaire composed of nine statements on the state of fatigue experienced during the previous week. The answers are within a scale of agreement ranging from 1 to 7, where 1 represents less fatigue and 7 indicates highest fatigue. The total score was obtained summing the number given at each item and it ranges from 7 to 63. An overall score of ≥36 indicates a state of fatigue. Questionnaires were completed electronically by participants, by means of a participant i-PAD at each study visit. Here, negative values indicate improvement in FSS score from baseline.|Baseline, Weeks 12 and 24|FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time-point.|||score on a scale||Standard Deviation|Mean
2565903|NCT02587065|Secondary|Change From Baseline in Number of Participants With Adherence to Study Treatment at Weeks 12 and 24|Adherence to treatment was evaluated using a questionnaire assessing adherence and the reasons for not taking drug at the recommended frequency of administration. Participants who had taken the prescribed doses of treatment in the previous 28 days were evaluated.|Baseline, Weeks 12 and 24|FAS population included all enrolled participants who took at least one dose of the study medication. Overall number of participants analyzed are the participants who were evaluated for the outcome measure.|||participants|||Number
2565904|NCT02587065|Secondary|Change From Baseline in the Score of All Domains of TSQM-9 at Week 24|TSQM is a 14-item instrument consisting of four scales: effectiveness scale (questions 1 to 3), side effects scale (questions 4 to 8), convenience scale (questions 9 to 11) and global satisfaction scale (questions 12 to 14). In TSQM-9, the five items related to side effects of medication were not included. The scores were computed by adding items for each domain. The lowest possible score was subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. Questionnaires were completed electronically by participants, by means of a participant i-PAD at each study visit.|Baseline, Week 24|FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time point.|||score on a scale||Standard Deviation|Mean
2565905|NCT02587065|Primary|Change From Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12|TSQM is a 14-item instrument consisting of four scales: effectiveness scale (questions 1 to 3), side effects scale (questions 4 to 8), convenience scale (questions 9 to 11) and global satisfaction scale (questions 12 to 14). In TSQM-9, the five items related to side effects of medication were not included. The scores were computed by adding items for each domain. The lowest possible score was subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that was then multiplied by 100. TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. Questionnaires were completed electronically by participants, by means of a participant i-PAD at each study visit.|Baseline, Week 12|FAS population included all enrolled participants who took at least one dose of the study medication. Number analyzed are the participants who were evaluated at each time point.|||score on a scale||Standard Deviation|Mean
2565906|NCT02586974|Secondary|Postoperative Pain|postoperative pain in patients undergoing robot-assisted radical prostatectomy (RARP) as measured by the Numeric Pain Rating Score (NRS), measured at patient awakening and after 12, 24, and 48 h from surgery. NRS goes from 0 to 10, where 0 means no pain and 10 the maximum pain possible.|changes in postoperative pain measured at patient awakening and then every 30 min in the recovery room, until discharge to the ward. Successively, it was measured at 12, 24, and 48 h||||Units on a scale||Standard Deviation|Mean
2565907|NCT02586974|Secondary|Cytokine Tumor Necrosis Factor (TNF)-Beta|mean levels of the pro-inflammatory cytokine tumor necrosis factor (TNF)-beta in patients undergoing robot-assisted radical prostatectomy (RARP), measured just before induction of anesthesia, after 2 h of pneumoperitoneum, 2 h from exsufflation, and 24 h after surgery|changes in cytokine levels just before induction of anesthesia, after 2 h of pneumoperitoneum, 2 h from exsufflation, and 24 h after surgery||||IU||Standard Deviation|Mean
2565908|NCT02586974|Secondary|Cytokine Interleukin-6 (IL-6)|mean levels of the pro-inflammatory cytokine interleukin-6 (IL-6) in patients undergoing robot-assisted radical prostatectomy (RARP), measured just before induction of anesthesia, after 2 h of pneumoperitoneum, 2 h from exsufflation, and 24 h after surgery|changes in cytokine levels measured just before induction of anesthesia, after 2 h of pneumoperitoneum, 2 h from exsufflation, and 24 h after surgery||||IU||Standard Deviation|Mean
2565912|NCT02586896|Secondary|Initiation in Participants With Higher Levels of Environmental Instability at Baseline|"Initiation is defined as a dichotomous outcome (yes/no), and is considered to have occurred if patients report any substance abuse counseling sessions (excluding SBCM) from the time of the baseline assessment up to the day before the three-month interview, as captured via self-report on the Form 90-D."|3 months|Intention to treat|||% of participants||Standard Error|Mean
2565913|NCT02586896|Secondary|Score on World Health Organization Quality of Life (WHOQoL) Brief Questionnaire|The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. Participants express how much they have experienced the items in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). Raw domain score is the sum of respective item scores. All domain scores are reported between 4 and 20.|3 months|Intention to treat|||units on a scale||Standard Deviation|Mean
2565914|NCT02586896|Secondary|Number of Participants With Successful Outcome for Opioid Use|"Successful outcome will be defined as 1) 3-month urine negative for opioids (opiates, oxycodone, methadone, buprenorphine, or propoxyphene) unless prescribed for opioid dependence, and 2) no more than two days of self-reported opioid use on the Form 90-D in the 4 weeks (30 days) prior to the 3-month evaluation."|3 months|Intention to treat|||Participants|||Count of Participants
2565915|NCT02586896|Primary|Engagement in Treatment for Opioid Dependence|"Using the same timeframe as initiation, engagement is defined as the number days of medication use for opioid dependence, based on Form 90-D self-report verified by clinic dosing logs and Prescription Drug Monitoring Program records."|3 months|Intention to treat|||% days||Standard Deviation|Mean
2565916|NCT02586896|Primary|Initiation of Treatment for Opioid Dependence|"Initiation is defined as a dichotomous outcome (yes/no), and is considered to have occurred if patients report any substance abuse counseling sessions (excluding SBCM) from the time of the baseline assessment up to the day before the three-month interview, as captured via self-report on the Form 90-D."|3 months|Intention to treat|||Participants|||Count of Participants
2565917|NCT02586805|Secondary|Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Day 14 Through Day 182|HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attacks during day 14 after study drug administration through day 182 was analyzed by the same poisson regression model as in the primary endpoint analysis.|From Day 14 to Day 182|ITT population included all randomized participants who received any exposure to the investigational product.|||Attacks per 4 weeks||95% Confidence Interval|Least Squares Mean
2565918|NCT02586805|Secondary|Rate of Moderate or Severe Investigator Confirmed Hereditary Angioedema (HAE) Attacks|HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Moderate and severe investigator-confirmed HAE attacks were the attacks that were moderate or severe as per the HAE attack assessment and reporting procedures (HAARP) defined severity. The overall severity of attack was determined by the investigator using following definitions: mild (transient or mild discomfort), moderate (mild to moderate limitation in activity), severe (marked limitation in activity). Rate of moderate or severe investigator confirmed HAE attack was analyzed using the GLM for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.|From Day 0 to Day 182|ITT population included all randomized participants who received any exposure to the investigational product.|||Attacks per 4 weeks||95% Confidence Interval|Least Squares Mean
2565919|NCT02586805|Secondary|Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attack Requiring Acute Treatment|HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attack was analyzed using the GLM for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.|From Day 0 to Day 182|ITT population included all randomized participants who received any exposure to the investigational product.|||Attacks per 4 weeks||95% Confidence Interval|Least Squares Mean
2565920|NCT02586805|Primary|Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During Treatment Period|HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attacks was analyzed using a generalized linear model (GLM) for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset variable in the model.|From Day 0 to Day 182|ITT population included all randomized participants who received any exposure to the investigational product.|||Attacks per 4 weeks||95% Confidence Interval|Least Squares Mean
2565921|NCT02586675|Secondary|Overall Survival (OS) at Six Months|Occurrence of Overall Survival at 6 months. OS: On study date to expired date or last visit date if not deceased.|6 months|All participants.|||percentage of participants||95% Confidence Interval|Number
2565922|NCT02586675|Secondary|Progression-free Survival (PFS) at Six Months|Occurrence of Progression Survival at 6 months. PFS: On study date to date of progression or the same as overall survival time if not progressed. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|6 months|All participants.|||percentage of participants||95% Confidence Interval|Number
2565964|NCT02585960|Secondary|Area Under the Plasma Concentration of BAX 855 From Zero to Infinity (AUC0-inf)|Area under the plasma concentration versus time curve from time 0 to infinity of BAX 855 were reported.|Pre-infusion, 15 - 30 minutes, 3, 8, 24, 48, 72 and 96 hours post-infusion|"Pharmacokinetic analysis set (PKAS) included all participants in the SAS that had at least one quantifiable post-dose FVIII activity level without major protocol deviations or events with potential to affect the PK analysis. Here Number of participants analyzed refer to number of participants evaluable for this outcome at specified time points."|||International units*hour per deciliter||Standard Deviation|Mean
2565923|NCT02586675|Primary|Recommended Phase II Dose (RP2D)|400-600 mg of Ribociclib, when taken with Tamoxifen 20 mg. The Phase I portion of the study is a dose escalation to confirm the dose limiting toxicity (DLT) and the RP2D for ribociclib with Tamoxifen. DLT is defined as an adverse event or abnormal laboratory value assessed as having a reasonable possibility related to the study medication, unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment (cycle 1) with LEE011 and Tamoxifen. National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 4.03 will be used for all grading. In this study, a DLT will occur if CTCAE grade 4 neutropenia lasts more than 4 consecutive days, if CTCAE grade 3 thrombocytopenia is associated with clinically significant bleeding or if there is grade 4 thrombocytopenia.|Up to 12 months|All participants|||dose in mg|||Number
2565924|NCT02586506|Secondary|The Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA Inhaler at the End of the Study|Participants' ability to correctly use the ELLIPTA inhaler was assessed at Visit 2 using the Correct Use Checklist by an ELLIPTA trained health care professional. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution.|Day 28|mITT Population|||Percentage||95% Confidence Interval|Number
2565925|NCT02586506|Secondary|The Percentage of Participants Who Rated the Ability to Tell How Many Doses Were Remaining in the ELLIPTA Inhaler as Easy or Very Easy at the End of the Study|"Participants rated how easy it was to determine how many doses were left in the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). Easy to use was defined as the combination of an easy or very easy rating choice. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution."|Day 28|mITT Population|||Percentage||95% Confidence Interval|Number
2565926|NCT02586506|Primary|The Percentage of Participants With Asthma Who Rated the Use of the ELLIPTA Inhaler as Easy or Very Easy, Among Those Who Demonstrated Correct Use of the Inhaler at the End of the Study.|"Participants rated how easy it was to use the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). Easy to use was defined as the combination of an easy or very easy rating choice. The percentage was reported overall for the single treatment group along with a 95% confidence interval (CI) for the percentage calculated using the exact binomial distribution."|Day 28|Modified Intent-to-Treat (mITT) Population: all participants who were screened and received at least one dose of study treatment (placebo) and were randomised to receive the ELLIPTA inhaler ease of use questionnaire version A or B at Visit 2.|||Percentage||95% Confidence Interval|Number
2565927|NCT02586493|Secondary|The Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA Inhaler at the End of the Study.|Participants' ability to correctly use the ELLIPTA inhaler was assessed at Visit 1 and Visit 2 using the Correct Use Checklist by an ELLIPTA trained health care professional. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution.|Day 30|mITT Population|||Percentage of Participants||95% Confidence Interval|Number
2565928|NCT02586493|Secondary|The Percentage of Participants Who Rated the Ability to Tell How Many Doses Were Remaining in the ELLIPTA Inhaler as Easy or Very Easy at the End of the Study.|"Participants rated how easy it was to determine how many doses were left in the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). Easy to use was defined as the combination of an easy or very easy rating choice. The percentage was reported overall for the single treatment group along with a 95% CI for the percentage calculated using the exact binomial distribution."|Day 30|mITT Population|||Percentage of Participants||95% Confidence Interval|Number
2565929|NCT02586493|Primary|Percentage of Participants With COPD Who Rate the Use of the ELLIPTA Inhaler as Easy or Very Easy, Among Those Who Demonstrate Correct Use of the Inhaler at the End of the Study.|"Participants rated how easy it was to use the ELLIPTA inhaler, using a four-point Likert scale (1-very easy, 2-easy, 3-difficult, 4-very difficult). Easy to use was defined as the combination of an easy or very easy rating choice. The percentage was reported overall for the single treatment group along with a 95% confidence interval (CI) for the percentage calculated using the exact binomial distribution. The percentage is based off the number of participants analyzed i.e the number of subjects in the MITT population (subjects who received a dose of study medication and were randomised)."|Day 30|Modified Intent-to-Treat (mITT) Population: all participants who were screened and received at least one dose of study treatment (placebo) and were randomised to receive the ELLIPTA inhaler ease of use questionnaire version A or B at Visit 2. Only participants with data available at the analysis time point were analyzed.|||Percentage||95% Confidence Interval|Number
2565930|NCT02586415|Other Pre-specified|Recanalization (Imaging Outcome)|Recanalization of the primary arterial occlusive lesion at 24-hours on CTA/MRA|24 hours (±6)|||||||
2565931|NCT02586415|Other Pre-specified|Reperfusion (Imaging Outcome)|Successful reperfusion defined as a >90% reduction in Tmax>6sec lesion volume between baseline and 24 hours|between baseline and 24 hours (+/- 6 hours)|||||||
2565932|NCT02586415|Other Pre-specified|Lesion Growth (Imaging Outcome)|Lesion growth between the RAPID-identified ischemic core on baseline imaging and the infarct volume at 24 hours (±6)|24 hours (±6)|||||||
2565933|NCT02586415|Other Pre-specified|Infarct Volume (Imaging Outcome)|Infarct volume on diffusion-weighted MRI (or CT if MRI not feasible) at 24 (±6) hours after randomization|24 (+/- 6) hours|||||||
2565934|NCT02586415|Other Pre-specified|Parenchymal Hematoma Type 2 (Safety Outcome)|PH 2 rates on the 24 hour scan (±6)|24 (±6) hours|||||||
2565935|NCT02586415|Other Pre-specified|Count of Participants With Symptomatic Intracranial Hemorrhage (Primary Safety Outcome)|Defined as NIHSS worsening of 4 or more points associated with brain hemorrhage within 36 hours of randomization|36 hours||||Participants|||Count of Participants
2565973|NCT02585960|Secondary|Treatment of Bleeding Episodes: Number of BAX 855 Infusions Per Bleeding Episode Required Until Bleed Resolution|Infusions of BAX 855 that were required until bleed resolution were reported.|From start of study treatment up to 12 months (completion or termination)|"FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. Here Number of participants analyzed refer to number of participants with treated bleeds."|||Infusions||Standard Deviation|Mean
2565936|NCT02586415|Secondary|Count of Patients With mRS 0-2 at Day 90 as a Measure of Functional Independence|"The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with 0 being perfect health without symptoms to 6 being death. 0 - No symptoms.~No significant disability. Able to carry out all usual activities, despite some symptoms.~Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~Moderate disability. Requires some help, but able to walk unassisted.~Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~Dead."|day 90|intention to treat|||Participants|||Count of Participants
2565937|NCT02586415|Primary|The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90|"The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with 0 being perfect health without symptoms to 6 being death. 0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead."|Day 90|intention to treat|||score on a scale||Inter-Quartile Range|Median
2565938|NCT02586025|Secondary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time|Left ventricular ejection fraction (LVEF) is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction. A normal LVEF ranges from 55% to 70%, as measured by echocardiogram (preferred) or multiple-gated acquisition (MUGA) scan. The same method should be used throughout the study for each participant and preferably performed and evaluated by the same assessor. Here, we report the change from baseline in LVEF over time.|Baseline; Day 1 of Cycles 2, 4, 5, 8, 11, and 20 (1 cycle = 21 days)|Safety Evaluable Population|||percentage points of LVEF||95% Confidence Interval|Mean
2565939|NCT02586025|Secondary|Maximum Change From Baseline in Left Ventricular Ejection Fraction (LVEF)|Left ventricular ejection fraction (LVEF) is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction. A normal LVEF ranges from 55% to 70%, as measured by echocardiogram (preferred) or multiple-gated acquisition (MUGA) scan. The same method should be used throughout the study for each participant and preferably performed and evaluated by the same assessor. Here, we report the maximum change from baseline in LVEF at any point during the study.|Baseline; Day 1 of Cycles 2, 4, 5, 8, 11, and 20 (1 cycle = 21 days)|Safety Evaluable Population|||percentage points of LVEF||Standard Deviation|Mean
2565940|NCT02586025|Secondary|Percentage of Participants Who Experienced a Secondary Cardiac Event|A secondary cardiac event is defined as an asymptomatic or mildly symptomatic (NYHA Class II) drop in left ventricular ejection fraction (LVEF) by multiple-gated acquisition (MUGA) scan or echocardiogram confirmed by a second LVEF assessment within approximately 3 weeks showing also a documented drop. A significant LVEF drop is defined as an absolute decrease of at least 10 points below the baseline measurement and to below 50%.|From Baseline until end of study (up to 5 years)|Safety Evaluable Population|||percentage of participants|||Number
2565941|NCT02586025|Secondary|Percentage of Participants Who Experienced a Primary Cardiac Event|A primary cardiac event is defined as heart failure (New York Heart Association [NYHA] Class III or NYHA Class IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction points from baseline and to below 50%.|From Baseline until end of study (up to 5 years)|Safety Evaluable Population|||percentage of participants|||Number
2565942|NCT02586025|Secondary|Percentage of Participants With At Least One Adverse Event During the Treatment-Free Follow-Up Period|The percentage of participants who experienced at least one adverse event during the treatment-free follow-up period is reported here. The treatment-free follow-up period started the day after the end of the overall study treatment period and continued until disease progression or recurrence or until 5 years after randomization of the last patient, whichever occurred first. At the clinical cut-off date for the primary analysis (23-Oct-2017), limited data were collected during the treatment-free follow-up period; full data will be reported at study completion.|From end of overall study treatment until disease progression or recurrence (up to 5 years)|Safety Evaluable Population|||percentage of participants|||Number
2565943|NCT02586025|Secondary|Percentage of Participants With At Least One Adverse Event During the Adjuvant Treatment Period|The percentage of participants who experienced at least one adverse event during the adjuvant period is reported here. The adjuvant treatment period began after primary surgery, upon receiving the first dose of any of the adjuvant study medications. It ended 42 days after the last dose of adjuvant study treatment upon treatment completion or discontinuation. The duration of one treatment cycle is 21 days; the administration of therapy in Cycle 5 should not occur until 2 weeks after surgery. At the clinical cut-off date for the primary analysis (23-Oct-2017), the majority of participants had not completed the adjuvant treatment. Limited data were collected during the adjuvant period; full data will be reported at study completion.|From Cycle 5 up to Cycle 20 (1 cycle = 21 days)|Safety Evaluable Population|||percentage of participants|||Number
2565944|NCT02586025|Secondary|Percentage of Participants With At Least One Adverse Event During the Neoadjuvant Treatment Period|The percentage of participants who experienced at least one adverse event during the neoadjuvant period is reported here. The neoadjuvant treatment period began after randomization upon receiving the first dose of any of the neoadjuvant study medications and ended before receiving the first dose of adjuvant study treatment. The duration of one treatment cycle is 21 days; the administration of therapy in Cycle 5 should not occur until 2 weeks after surgery.|Baseline up to end of Cycle 4 (1 cycle = 21 days)|Safety Evaluable Population|||percentage of participants|||Number
2565985|NCT02585934|Secondary|The Dependence Scale (DS) Score Change From Baseline to Week 24|The DS measures the amount of assistance patients with dementia require in performing daily activities. The scale consists of 13 items, representing a range of severity from mild to severe levels of dependency. The score range is from 0 to 15 with higher scores indicating greater dependency.|Baseline, 24 weeks|ITT population at both timepoints|||units on a scale||Standard Error|Least Squares Mean
2565945|NCT02586025|Secondary|Kaplan-Meier Estimate of the Percentage of Participants With 3 Years of Overall Survival|The Kaplan-Meier approach will be used to estimate the percentage of participants with 3 years of overall survival (OS). OS was defined as the time from randomization to death from any cause. After treatment completion/discontinuation, follow-up data will be collected every 3 months for 1 year and then every 6 months thereafter, until disease progression or recurrence or until 5 years after randomization of the last participant, whichever occurs first. Data from participants who are alive at the time of the analysis are planned to be censored as of the last date they were known to be alive.|From Baseline to OS event or date last known to be alive (up to 5 years)|ITT population. At the time of the clinical cut-off date (23 October 2017) for the primary analysis, OS data were not mature and were not yet analyzed. The collection of survival follow-up data is ongoing and results will be analyzed and reported upon completion of the study.||||||
2565946|NCT02586025|Secondary|Kaplan-Meier Estimate of the Percentage of Participants With 3 Years of Disease-Free Survival|The Kaplan-Meier approach will be used to estimate the percentage of participants with 3 years of disease-free survival (DFS). DFS was defined as the time from first date of no disease (i.e., date of surgery) to first documentation of one of the following events: Disease recurrence (local, regional, distant, or contralateral) after surgery. Any evidence of contralateral disease in situ was not identified as disease recurrence; Death from any cause. After treatment completion/discontinuation, follow-up data will be collected every 3 months for 1 year and then every 6 months thereafter, until disease progression or recurrence or until 5 years after randomization of the last participant, whichever occurs first. Participants were considered to be disease-free if they underwent surgery and no recurrence of disease was reported thereafter. Data from participants who do not have an event at analysis are planned to be censored as of the date they are last known to be alive and event-free.|From surgery to DFS event or date last known to be alive and event-free (up to 5 years)|Only participants who underwent surgery are planned to be included in the analysis. At the time of the clinical cut-off date (23 October 2017) for the primary analysis, DFS data were not mature and were not yet analyzed. The collection of survival follow-up data is ongoing and results will be analyzed and reported upon completion of the study.||||||
2565947|NCT02586025|Secondary|Kaplan-Meier Estimate of the Percentage of Participants With 3 Years of Event-Free Survival|The Kaplan-Meier approach will be used to estimate the percentage of participants with 3 years of event-free survival (EFS). EFS is defined as the time from randomization to the first documentation of one of the following events: Disease progression (before surgery) as determined by the investigator with use of RECIST v1.1 Any evidence of contralateral disease in situ was not identified as progressive disease; Disease recurrence (local, regional, distant, or contralateral) after surgery; Death from any cause. After treatment completion/discontinuation, follow-up data will be collected every 3 months for 1 year and then every 6 months thereafter, until disease progression or recurrence or until 5 years after randomization of the last participant, whichever occurs first. Participants who do not have an EFS event at the time of the analysis are planned to be censored as of the date they are last known to be alive and event-free.|From Baseline to EFS event or date last known to be alive and event-free (up to 5 years)|ITT population. At the time of the clinical cut-off date (23 October 2017) for the primary analysis, EFS data were not mature and were not yet analyzed. The collection of survival follow-up data is ongoing and results will be analyzed and reported upon completion of the study.||||||
2565948|NCT02586025|Secondary|Percentage of Participants With an Objective Response (Complete or Partial Response) During Cycles 1-4, According to RECIST Version 1.1|An objective response was defined as the percentage of participants who achieved a complete response or partial response as the best tumor response during the neoadjuvant period (that is, during Cycles 1‒4 prior to surgery), as determined by the investigator on the basis of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. No confirmation was required for objective response. Only participants with measurable disease at baseline were included in the analysis. The duration of one treatment cycle is 21 days; the administration of therapy in Cycle 5 should not occur until 2 weeks after surgery.|At surgery (Cycle 4 Days 22-35)|ITT Population|||percentage of participants||95% Confidence Interval|Number
2565949|NCT02586025|Secondary|Percentage of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease During Cycles 1-4, According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Clinical responses that include the percentage of participants with a Complete Response, Partial Response, Stable Disease, or Progressive Disease were determined by the investigator during Cycles 1‒4 (prior to surgery) on the basis of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Only participants with measurable disease at baseline were included in the analysis. The analysis was based on the Intent-to-Treat (ITT) population with participants grouped by the treatment assigned at the time of randomization. The duration of one treatment cycle is 21 days; the administration of therapy in Cycle 5 should not occur until 2 weeks after surgery.|At surgery (Cycle 4 Days 22-35)|ITT Population|||percentage of participants||95% Confidence Interval|Number
2565950|NCT02586025|Secondary|Percentage of Participants With bpCR as Assessed by the Local Pathologist|This bpCR was assessed by the local pathologist. bpCR is defined as the absence of any residual invasive cancer on the hematoxylin and eosin evaluation of the resected breast specimen after completion of neoadjuvant therapy and surgery (that is, ypT0/is in accordance with current AJCC staging system). The analysis was based on the Intent-to-Treat (ITT) population with participants grouped by the treatment assigned at the time of randomization. Participants whose bpCR assessment was missing or invalid were counted as not achieving bpCR. The duration of one treatment cycle is 21 days; the administration of therapy in Cycle 5 should not occur until 2 weeks after surgery.|At surgery (Cycle 4 Days 22-35)|ITT Population|||percentage of participants||95% Confidence Interval|Number
2565951|NCT02586025|Secondary|Percentage of Participants With Breast Pathologic Complete Response (bpCR), Defined as ypT0/is According to the American Joint Committee on Cancer Staging System as Assessed by the IRC|This bpCR was assessed by the IRC. bpCR is defined as the absence of any residual invasive cancer on the hematoxylin and eosin evaluation of the resected breast specimen after completion of neoadjuvant therapy and surgery (that is, ypT0/is, in accordance with current AJCC staging system). The analysis was based on the Intent-to-Treat (ITT) population with participants grouped by the treatment assigned at the time of randomization. Participants whose bpCR assessment was missing or invalid were counted as not achieving bpCR. The duration of one treatment cycle is 21 days; the administration of therapy in Cycle 5 should not occur until 2 weeks after surgery.|At surgery (Cycle 4 Days 22-35)|ITT Population|||percentage of participants||95% Confidence Interval|Number
2565952|NCT02586025|Secondary|Percentage of Participants With tpCR as Assessed by the Local Pathologist|This tpCR was assessed by the local pathologist. tpCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes after completion of neoadjuvant therapy and surgery (that is, ypT0/is, ypN0, in accordance with the current American Joint Committee on Cancer [AJCC] staging system). The analysis was based on the Intent-to-Treat (ITT) population with participants grouped by the treatment assigned at the time of randomization. Participants whose tpCR assessment was missing or invalid were counted as not achieving tpCR. The duration of one treatment cycle is 21 days; the administration of therapy in Cycle 5 should not occur until 2 weeks after surgery.|At surgery (Cycle 4 Days 22-35)|ITT Population|||percentage of participants||95% Confidence Interval|Number
2565953|NCT02586025|Primary|Percentage of Participants With Total Pathologic Complete Response (tpCR) as Assessed by the Independent Review Committee (IRC)|This tpCR was assessed by the independent review committee (IRC). tpCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes after completion of neoadjuvant therapy and surgery (that is, ypT0/is, ypN0, in accordance with the current American Joint Committee on Cancer [AJCC] staging system). The analysis was based on the Intent-to-Treat (ITT) population with participants grouped by the treatment assigned at the time of randomization. Participants whose tpCR assessment was missing or invalid were counted as not achieving tpCR. The duration of one treatment cycle is 21 days; the administration of therapy in Cycle 5 should not occur until 2 weeks after surgery.|At surgery (Cycle 4 Days 22-35)|ITT Population|||percentage of participants||95% Confidence Interval|Number
2565954|NCT02585999|Secondary|NGMN Levels Over 12 Weeks of Continuous Patch Use|Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess NGMN|12 weeks|Analysis was performed on all samples. Thus samples for 28 participants were analyzed, including the one participant who began the study but withdrew early [lost to follow up]. The first blood draw occurred at the end of the first patch week; there was no baseline draw prior to patch use.|||ng/ml||Standard Deviation|Mean
2565955|NCT02585999|Primary|Change in Serum EE2 Levels Over 12 Weeks of Continuous Contraceptive Patch Use|Liquid chromatography-tandem triple quadrupole mass spectrometry was utilized to assess EE2|Total of 18 blood draws - once at the end of each patch week and two times during weeks four, eight and twelve (with the additional blood draw occurring mid-week); and blood draws performed for three continuous days after the final patch was removed|Analysis was performed on all samples. Thus samples for 28 participants were analyzed, including the one participant who began the study but withdrew early [lost to follow up]. The first blood draw occurred at the end of the first patch week; there was no baseline draw prior to patch use.|||pg/ml||Standard Deviation|Mean
2565956|NCT02585960|Secondary|Incremental Recovery (IR) Over Time|Incremental recovery was calculated by BAX 855 increment (IU/dL) / BAX 855 dose (IU/kg).|Baseline, Month 3, 6, 7.5, 9, 10.5, 12 (Completion or termination)|"PKAS included all participants in the SAS that had at least one quantifiable post-dose FVIII activity level without major protocol deviations or events with potential to affect the PK analysis. Here Number of participants analyzed refer to number of participants evaluable for this outcome at specified time points."|||IU/dL per IU/kg||Standard Deviation|Mean
2565957|NCT02585960|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution was defined as the theoretical volume in which the total amount of drug was uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steadystate.|Pre-infusion, 15 - 30 minutes, 3, 8, 24, 48, 72 and 96 hours post-infusion|PKAS included all participants in the SAS that had at least one quantifiable post-dose FVIII activity level without major protocol deviations or events with potential to affect the PK analysis.|||Deciliters per kilogram (dL/kg)||Standard Deviation|Mean
2565958|NCT02585960|Secondary|Total Body Clearance (CL) of BAX 855|Total body clearance of BAX 855 from blood by the kidney were reported.|Pre-infusion, 15 - 30 minutes, 3, 8, 24, 48, 72 and 96 hours post-infusion|PKAS included all participants in the SAS that had at least one quantifiable post-dose FVIII activity level without major protocol deviations or events with potential to affect the PK analysis.|||Deciliters per kilogram * hour (dL/kg*h)||Standard Deviation|Mean
2565959|NCT02585960|Secondary|Time to Maximum Concentration of BAX 855 in Plasma (Tmax)|Tmax of BAX 855 were reported.|Pre-infusion, 15 - 30 minutes, 3, 8, 24, 48, 72 and 96 hours post-infusion|PKAS included all participants in the SAS that had at least one quantifiable post-dose FVIII activity level without major protocol deviations or events with potential to affect the PK analysis.|||hour (h)||Full Range|Median
2565960|NCT02585960|Secondary|Maximum Plasma Concentration (Cmax) of BAX 855|Cmax of BAX 855 were reported.|Pre-infusion, 15 - 30 minutes, 3, 8, 24, 48, 72 and 96 hours post-infusion|"PKAS included all participants in the SAS that had at least one quantifiable post-dose FVIII activity level without major protocol deviations or events with potential to affect the PK analysis. Here Number of participants analyzed refer to number of participants evaluable for this outcome at specified time points."|||International units per deciliter(IU/dL)||Standard Deviation|Mean
2565961|NCT02585960|Secondary|Mean Residence Time (MRT) of BAX 855|MRT of BAX 855 were reported.|Pre-infusion, 15 - 30 minutes, 3, 8, 24, 48, 72 and 96 hours post-infusion|Pharmacokinetic analysis set (PKAS) included all participants in the SAS (participants enrolled who had at least 1 BAX 855 infusion) that had at least one quantifiable post-dose FVIII activity level without major protocol deviations or events with potential to affect the PK analysis.|||hour (h)||Full Range|Median
2565962|NCT02585960|Secondary|Plasma Half-life (T1/2) of BAX 855|T1/2 of BAX 855 in plasma were reported.|Pre-infusion, 15 - 30 minutes, 3, 8, 24, 48, 72 and 96 hours post-infusion|PKAS included all participants in the SAS that had at least one quantifiable post-dose FVIII activity level without major protocol deviations or events with potential to affect the PK analysis.|||hour (h)||Full Range|Median
2565963|NCT02585960|Secondary|Incremental Recovery (IR) at Maximum Plasma Concentration (Cmax) of BAX 855|IR at Cmax of BAX 855 were reported.|Pre-infusion, 15 - 30 minutes, 3, 8, 24, 48, 72 and 96 hours post-infusion|"PKAS included all participants in the SAS that had at least one quantifiable post-dose FVIII activity level without major protocol deviations or events with potential to affect the PK analysis. Here Number of participants analyzed refer to number of participants evaluable for this outcome at specified time points."|||(IU/dL) / (IU/kg)||Standard Deviation|Mean
2565965|NCT02585960|Secondary|Change From Baseline in Physical Component Scores (PCS) of the Short Form-36 (SF-36) Health Survey|Short Form (36) Health Survey (SF-36) is a 36-item validated, generic health related quality of life (HR QoL) instrument. PCS is a summary scale of the dimensions physical functioning, role physical, bodily pain, and general health. The component score is normalized to a standard population. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both sub-scores and summary scores.|Baseline, Month 12 (completion or termination)|"FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. Here Number of participants analyzed refer to number of participants evaluable for this outcome at specified time points."|||Score on a scale||Standard Deviation|Mean
2565966|NCT02585960|Secondary|Number of Participants With Positive Inhibitory Antibodies and Binding Antibodies to Factor VIII (FVIII), BAX 855, Polyethylene Glycol (PEG), and Chinese Hamster Ovary (CHO) Protein|Positive Inhibitory Antibodies and Binding Antibodies to Factor VIII (FVIII), BAX 855, Polyethylene Glycol (PEG), and Chinese Hamster Ovary (CHO) Protein were reported here.|From start of study treatment up to 12 months (completion or termination)|SAS included all participants enrolled who had at least one BAX 855 infusion.|||Participants|||Count of Participants
2565967|NCT02585960|Secondary|Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters Reported as Treatment Related Adverse Events|Clinical laboratory assessments included clinical chemistry, hematology, lipid panel, genetics, T-cell, B-cell and NK cell (TBNK) and viral serology.|From start of study treatment up to 12 months (completion or termination)|SAS included all participants enrolled who had at least one BAX 855 infusion.|||Participants|||Count of Participants
2565968|NCT02585960|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs Reported as Treatment Related Adverse Events|Vital signs included systolic and diastolic blood pressure, pulse rate, respiratory rate, body temperature.|From start of study treatment up to 12 months (completion or termination)|SAS included all participants enrolled who had at least one BAX 855 infusion.|||Participants|||Count of Participants
2565969|NCT02585960|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any unfavorable and unintended sign (an abnormal laboratory finding), symptom (rash, pain, discomfort, fever, dizziness, etc.), disease (peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an investigational product (IP), whether or not considered causally related to the IP. A SAE was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/results in death, life-threatening, required in-patient hospitalization or resulted in prolongation of an existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event that was not immediately life-threatening or resulted in death or required hospitalization but jeopardize the participant or required medical or surgical intervention to prevent any of the above outcomes.|From start of study treatment up to 12 months (completion or termination)|SAS included all participants enrolled who had at least one BAX 855 infusion.|||Participants|||Count of Participants
2565970|NCT02585960|Secondary|Blood Loss Per Participant in Case of Surgery|"The intraoperative blood loss was measured by determining the volume of blood and fluid removal through suction into the collection container (waste box and/or cell saver) and the estimated blood loss into swabs and towels during the procedure, per the anesthesiologist's record. Postoperatively, blood loss was determined by the drainage volume collected, which mainly consisted of drainage fluid via vacuum or gravity drain, as applicable. In cases where no drain was present, blood loss was determined by the surgeon's clinical judgment, as applicable or entered as not available. Blood loss was evaluated intra-operatively (from start to end of the procedure), post-operatively (from the end of procedure up to 24 h post procedure), and perioperatively (from the start of procedure to participant discharge from hospital or 14 days after completion of procedure; whichever was first)."|Day 0 through discharge or 14 days post-surgery|Surgery analysis set included all participants in the FAS (randomized to one of the two prophylactic arms and treated prophylactically for any period of time) who underwent some form of surgery (including dental) during the course of study participation.|||Milliliters (mL)||Standard Deviation|Mean
2565971|NCT02585960|Secondary|Number of Participants With Hemostatic Efficacy Ratings for BAX 855 Treatment of Operative Bleeds|The participant or caregiver rated the overall treatment response using a 4-point efficacy rating scale as Excellent: Full relief of pain and cessation of objective signs of bleeding after a single infusion and no additional infusion is required for the control of bleeding; Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion and possibly requires more than 1 infusion for complete resolution; Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after a single infusion and required more than 1 infusion for complete resolution and None: No improvement or condition worsens. Hemostatic efficacy was evaluated intra-operatively (from start to end of the procedure), post-operatively (from the end of procedure up to 24 h post procedure), and perioperatively (from the start of procedure to participant discharge from hospital or 14 days after completion of procedure; whichever was first).|Day 0 through discharge or 14 days post-surgery|Surgery analysis set included all participants in the FAS (randomized to one of the two prophylactic arms and treated prophylactically for any period of time) who underwent some form of surgery (including dental) during the course of study participation.|||Participants|||Count of Participants
2565972|NCT02585960|Secondary|Change From Baseline in Hemophilia Joint Health Score (HJHS)- Total Score|HJHS was assessed based on the following components of the elbow, knee, and ankle joints: swelling, duration of swelling, muscle atrophy, crepitus on motion, flexion loss, extension loss, joint pain, and strength, together with an assessment of the global gait. The HJHS is a validated 11-item scoring tool based on radiologic and clinical evaluation, sensitive to detect early signs and minor changes. HJHS ranges from 0 to 124. Higher values in the HJHS represent worse situation for the participant.|Baseline, Month 12|"FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. Here Number of participants analyzed refer to number of participants evaluable for this outcome at specified time points."|||Score on a scale||Standard Deviation|Mean
2566032|NCT02585700|Secondary|Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens.||Pre- (Day 0) and post-vaccination (Day 21)|All vaccinated subjects who have valid post vaccination immunogenicity measures with no major protocol violations|||Titers||95% Confidence Interval|Mean
2565974|NCT02585960|Secondary|Number of Bleeding Episodes: Overall Hemostatic Efficacy Rating at Bleed Resolution|The participant or caregiver rated the overall treatment response using a 4-point efficacy rating scale as Excellent: Full relief of pain and cessation of objective signs of bleeding after a single infusion and no additional infusion is required for the control of bleeding; Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion and possibly requires more than 1 infusion for complete resolution; Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after a single infusion and required more than 1 infusion for complete resolution and None: No improvement or condition worsens.|From start of study treatment up to bleed resolution (up to 12 months)|"FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. Here Number of participants analyzed refer to number of participants evaluable for this outcome at specified time points."|||Treated Bleeds|Bleeds||Number
2565975|NCT02585960|Secondary|Number of Bleeding Episodes: Overall Hemostatic Efficacy Rating at Number of Infusions|The participant or caregiver rated the overall treatment response using a 4-point efficacy rating scale as Excellent: Full relief of pain and cessation of objective signs of bleeding after a single infusion and no additional infusion is required for the control of bleeding; Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion and possibly requires more than 1 infusion for complete resolution; Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after a single infusion and required more than 1 infusion for complete resolution and None: No improvement or condition worsens.|8 hours after study drug administration|"FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. Here Number of participants analyzed refer to number of participants evaluable for this outcome at specified time points."|||Treated Bleeds|Bleeds||Number
2565976|NCT02585960|Secondary|Total Weight-adjusted Consumption of BAX 855|Total weight-adjusted consumption of BAX 855 were reported.|From start of study treatment up to 12 months (completion or termination)|FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time.|||International units per kilogram (IU/kg)||Standard Deviation|Mean
2565977|NCT02585960|Secondary|Annualized Joint Bleeding Rate (AJBR) for Second Six Months|Annualized joint bleeding rate was determined by dividing the number of joint bleeds by observation period in years. An acute joint bleed include some or all of the following: 'aura', pain, swelling, warmth of the skin over the joint, decreased range of motion and difficulty in using the limb compared with baseline or loss of function.|Day 183 to Day 364 (6 months)|"FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. Here Number of participants analyzed refer to number of participants evaluable for this outcome at specified time points."|||Bleeds per year||Standard Deviation|Mean
2565978|NCT02585960|Secondary|Annualized Traumatic Bleeding Rate for Second Six Months|Annualized traumatic bleeding rate was determined by dividing the number of traumatic bleeds by observation period in years. A bleed was defined as traumatic if it was related to injury/trauma.|Day 183 to Day 364 (6 months)|"FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. Here Number of participants analyzed refer to number of participants evaluable for this outcome at specified time points."|||Bleeds per year||Standard Deviation|Mean
2565979|NCT02585960|Secondary|Annualized Spontaneous Bleeding Rate for Second Six Months|Annualized spontaneous bleeding rate was determined by dividing the number of spontaneous bleeds by observation period in years. A bleed was defined as spontaneous if it was not related to injury/trauma.|Day 183 to Day 364 (6 months)|"FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. Here Number of participants analyzed refer to number of participants evaluable for this outcome at specified time point."|||Bleeds per year||Standard Deviation|Mean
2565980|NCT02585960|Secondary|Total Annualized Bleeding Rate for Second Six Months|Annualized bleeding rate was determined by dividing the number of bleeds by observation period in years.|Day 183 to Day 364 (6 months)|"FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. Here Number of participants analyzed refer to number of participants evaluable for this outcome at specified time point."|||Bleeds per year||Standard Deviation|Mean
2565981|NCT02585960|Primary|Percentage of Participants With a Total Annualized Bleeding Rate (ABR) of Zero for Second Six Months|Annualized bleeding rate was determined by dividing the number of bleeds by observation period in years.|Day 183 to Day 364 (6 months)|Full analysis set (FAS) included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time.|||Percentage of participants|||Number
2565982|NCT02585934|Secondary|Measurement of Concentrations of RVT-101 (Intepirdine) in Plasma|Measurement collected at timepoints Week 6, Week 12, Week 18, and Week 24|Week 6, Week 12, Week 18, Week 24|PK population at specified timepoints: Week 6, Week 12, Week 18, and Week 24|||ng/mL||95% Confidence Interval|Geometric Mean
2565983|NCT02585934|Secondary|ADAS-Cog-13 Score Change From Baseline to Week 24|13-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. Most items are evaluated by tests, but some are dependent on clinician ratings on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 additional items: delayed word recall and total digit cancellation. Scores for the ADAS-Cog-13 range from 0 to 85 with higher scores indicating greater dysfunction.|Baseline, 24 weeks|ITT at both timepoints|||units on a scale||Standard Error|Least Squares Mean
2565984|NCT02585934|Secondary|Neuropsychiatric Inventory (NPI) Score Change From Baseline to Week 24|The NPI is a behavior rating scale composed of a 12-item structured interview of the caregiver that is scored from 0 to 144 (the higher the score, the greater the psychiatric disturbance). It assesses 12 behavioral disturbances occurring in dementia patients: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor activity, night-time behavior disturbances, and eating disturbances. Both the frequency and the severity of each behavior are determined.|Baseline and Week 24|ITT Population at both timepoints|||units on a scale||Standard Error|Least Squares Mean
2566091|NCT02584686|Secondary|SEP-Q2 Question Before Treatment|"Number of patients answering Yes to the Sexual Encounter Profile question 2 (SEP-Q2: Were you able to insert your penis into your partner's vagina?)"|Baseline||||participants|||Number
2565986|NCT02585934|Secondary|Clinical Global Impression of Change - Plus Caregiver Interview (CIBIC+) Score at Week 24|"The CIBIC+ assessment measures the global functioning of the subject. The CIBIC+ is scored as a seven-point categorical rating, ranging from a score of 1 (indicating very much improved), to a score of 4 (indicating no change), or to a score of 7 (indicating very much worse.) Lower CIBIC+ scores indicate better (more desirable) function"|24 weeks|ITT population at the Week 24 timepoint|||units on a scale||Standard Error|Least Squares Mean
2565987|NCT02585934|Primary|Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score Change From Baseline to Week 24|The ADCS-ADL scale measures functional impairment in terms of activities of daily living. The score ranges from 0 to 78. The lower the score, the greater the impairment; higher scores indicate better (more desirable) function|Baseline, 24 weeks|ITT Population with data at both endpoints|||units on a scale||Standard Error|Least Squares Mean
2565988|NCT02585934|Primary|Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Score Change From Baseline to Week 24|The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.|Baseline, 24 weeks|ITT Population with data at both timepoints.|||units on a scale||Standard Error|Least Squares Mean
2565989|NCT02585895|Secondary|Percent Change From Baseline in Total Cholesterol/High-density Lipoprotein Cholesterol Ratio||Baseline and Week 4|Randomized participants with non-missing data|||percent change||Standard Error|Least Squares Mean
2565990|NCT02585895|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein-Cholesterol||Baseline and Week 4|Randomized participants with non-missing data|||percent change||Standard Error|Least Squares Mean
2565991|NCT02585895|Secondary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol||Baseline and week 4|Randomized participants with non-missing data|||percent change||Standard Error|Least Squares Mean
2565992|NCT02585895|Primary|Percentage of Participants With Apheresis Avoidance at the End of Randomized Therapy|"Avoidance of apheresis at end of randomized therapy was defined as no apheresis at week 5 and week 6. Aperesis at weeks 5 or 6 was based on LDL-C level at week 4:~participants with LDL-C ≥ 100 mg/dL at week 4 received apheresis at week 5 (participants who received apheresis QW before study entry) or week 6 (participants who received apheresis Q2W prior to study entry). If LDL-C was < 100 mg/dL at week 4, no apheresis was performed at week 5 or week 6, irrespective of assigned treatment group.~Participants who ended the study prior to week 6 were considered as not achieving apheresis avoidance."|Week 5 and week 6|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2565993|NCT02585843|Secondary|Change From Baseline to Day 7 on the Seven-Level Likert Scale|Dyspnea will be assessed using a Seven-Level Likert Scale at baseline and the day 7 visit. The outcome measure will be reported as a difference between these two assessments (value at 7 days minus the value at baseline). The values on this scale range from 1 to 7 with higher numbers indicating overall better subjective assessment related to the symptom of dyspnea. Therefore, positive numbers represent an overall improvement in dyspnea during the study intervention and the higher (more positive) this difference is, the better the subject's relief of dyspnea at the conclusion of the study intervention.|7 days||||units on a scale||Standard Deviation|Mean
2565994|NCT02585843|Secondary|Change in Score on the Visual Analogue Scale (VAS)|Dyspnea will be assessed at baseline and at 7 days with the score on the visual analogue scale (VAS). The scores range from 0 (minimum) to 100 (maximum) with higher numbers representing improvements in dyspnea (i.e. better) and lower numbers representing worsening of dyspnea (i.e. worse).|7 days||||units on a scale||Standard Deviation|Mean
2565995|NCT02585843|Secondary|Change in 6-minute Walk Test Distance (6MWT)|At baseline and final visit. The 6MWT will be conducted per American Thoracic Society guidelines.|7 days||||meters||Standard Deviation|Mean
2565996|NCT02585843|Secondary|Change in Estimated Jugular Venous Pressure (cmH2O)|Change in estimated jugular venous pressure by physical exam in cmH2O between baseline and 7 days|7 days||||cmH2O||Standard Deviation|Mean
2565997|NCT02585843|Primary|Change in Body Weight|change in body weight measured in kilograms between weight at baseline and weight at 7 days|7 days||||kilogram||Standard Deviation|Mean
2565998|NCT02585830|Primary|Insulin Sensitivity|After an overnight fast, participants completed an oral glucose tolerance test (OGTT) in the morning. Participants consumed a 75g dextrose drink and serum for glucose and insulin concentrations were collected at baseline and every 30 minutes for 3 hours. The homeostatic model assessment for insulin resistance (HOMA-IR) was calculated as [fasting insulin (μU/ml) x fasting glucose (mmol/l)] / 22.5); lower HOMA-IR indicates better insulin sensitivity. The Matsuda Index was calculated as √10,000 / [[fasting insulin (μU/ml) x fasting glucose (mmol/l)] x [mean OSTT insulin (μU/ml) x mean OSTT glucose (mmol/l)]]; high Matsuda Index indicates better insulin sensitivity.|3 hours|1 participant with missing data|||units on a scale||Standard Deviation|Mean
2565999|NCT02585830|Primary|Dim Light Melatonin Onset and Offset|~1mL saliva was collected at 30- to 60- minute intervals in dim light (<5 lux in the angle of gaze, approximately the light level of candlelight or civil twilight) from approximately 5pm until noon the next day. Dim light melatonin onset (DLMOn) was defined as the linear interpolated clock time at which evening salivary melatonin concentrations increased and remained above a threshold of 3pg/mL. Melatonin offset (DLMOff) was the linear interpolated clock time at which salivary melatonin concentrations fell below this threshold. Later DLMOn and DLMOff are indicative of a later circadian rhythm.|1 day||||decimal hours||Standard Deviation|Mean
2566000|NCT02585778|Secondary|Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - On-Treatment Analysis|Glucose lowering treatment was calculated for non-insulin treatments as one for each unique treatment received and for insulin treatment as one in total for all participants who have taken one or more treatments. Absolute change = number of glucose-lowering treatments at specified weeks minus baseline value.|Baseline, Weeks 12 and 24|mITT population.|||glucose lowering treatments||Standard Deviation|Mean
2566001|NCT02585778|Secondary|Absolute Change From Baseline in Number of Glucose-Lowering Treatments at Weeks 12 and 24 - ITT Analysis|Glucose lowering treatment was calculated for non-insulin treatments as one for each unique treatment received and for insulin treatment as one in total for all participants who have taken one or more treatments. Absolute change = number of glucose-lowering treatments at specified weeks minus baseline value.|Baseline, Weeks 12 and 24|ITT population.|||glucose lowering treatments||Standard Deviation|Mean
2566002|NCT02585778|Secondary|Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - On-Treatment Analysis|Absolute change = daily insulin dose/kg at specified weeks minus baseline value.|Baseline, Weeks 12 and 24|mITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively.|||U/kg||Standard Deviation|Mean
2566003|NCT02585778|Secondary|Absolute Change From Baseline in Insulin Daily Dose/Kg at Weeks 12 and 24 - ITT Analysis|Absolute change = daily insulin dose/kg at specified weeks minus baseline value.|Baseline, Weeks 12 and 24|ITT population . Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively.|||U/kg||Standard Deviation|Mean
2566004|NCT02585778|Secondary|Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - On-Treatment Analysis|Absolute change = total daily insulin dose at specified weeks minus baseline value.|Baseline, Weeks 12 and 24|mITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively.|||units (U)||Standard Deviation|Mean
2566005|NCT02585778|Secondary|Absolute Change From Baseline in Total Daily Insulin Dose at Weeks 12 and 24 - ITT Analysis|Absolute change = total daily insulin dose at specified weeks minus baseline value.|Baseline, Weeks 12 and 24|ITT population . Here, ‘Number Analyzed’ = participants with available data at the specified time points for each arm, respectively.|||units (U)||Standard Deviation|Mean
2566006|NCT02585778|Secondary|Absolute Change From Baseline in FPG at Weeks 12 and 24 - On-Treatment Analysis|Absolute change = FPG value at specified weeks minus FPG value at baseline.|Baseline, Weeks 12 and 24|mITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively.|||mmol/L||Standard Deviation|Mean
2566007|NCT02585778|Secondary|Absolute Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 12 and 24 - ITT Analysis|Absolute change = FPG value at specified weeks minus FPG value at baseline.|Baseline, Weeks 12 and 24|ITT population. Here, ‘Number Analyzed’ = participants with available data at the specified time points for each arm, respectively.|||mmol/L||Standard Deviation|Mean
2566008|NCT02585778|Secondary|Absolute Change From Baseline in HbA1c at Weeks 12 and 24 - On-Treatment Analysis|Absolute change = HbA1c value at specified weeks minus HbA1c value at baseline.|Baseline, Weeks 12 and 24|mITT population. Here, 'Number Analyzed' = participants with available data at the specified time points for each arm, respectively.|||percentage of hemoglobin||Standard Deviation|Mean
2566009|NCT02585778|Secondary|Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 - ITT Analysis|Absolute change = HbA1c value at specified weeks minus HbA1c value at baseline.|Baseline, Weeks 12 and 24|ITT population. Here, ‘Number Analyzed’ = participants with available data at the specified time points for each arm, respectively.|||percentage of hemoglobin||Standard Deviation|Mean
2566010|NCT02585778|Secondary|Percent Change From Baseline in LDL-C Particle Size at Week 24 - ITT Analysis|LDL-C particle size was calculated from lipid subfractions by NMR spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline LDL-C particle size value on- or off-treatment (LDL-C particle size ITT population).|||percent change||Standard Error|Least Squares Mean
2566011|NCT02585778|Secondary|Percent Change From Baseline in LDL-C Particle Number at Week 24 - ITT Analysis|LDL-C particle number was calculated from lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy. Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline LDL-C particle number value on- or off-treatment (LDL-C particle number ITT population).|||percent change||Standard Error|Least Squares Mean
2566012|NCT02585778|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach for handling of missing data followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2566013|NCT02585778|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2566014|NCT02585778|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach for handling of missing data followed by robust regression model. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2566015|NCT02585778|Secondary|Percentage of Participants Reaching Calculated Non-HDL-C <80 mg/dL at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|Up to Week 24|Non-HDL-C mITT population.|||percentage of participants|||Number
2566016|NCT02585778|Secondary|Percentage of Participants Reaching Calculated Non-HDL-C <100 mg/dL at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|Up to Week 24|Participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment (Non-HDL-C mITT population).|||percentage of participants|||Number
2566017|NCT02585778|Secondary|Percentage of Participants Reaching Calculated LDL-C <50 mg/dL (1.3 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from last observation carried forward (LOCF) approach (for T1DM participants) and multiple imputation approach model (for T2DM participants) including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection). The maximum likelihood estimate did not exist as response rate was zero in a treatment group of T1DM participants.|Up to Week 24|mITT population.|||percentage of participants|||Number
2566018|NCT02585778|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|Up to Week 24|mITT population.|||percentage of participants|||Number
2566019|NCT02585778|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment (Total-C ITT population).|||percent change||Standard Error|Least Squares Mean
2566020|NCT02585778|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).|||percent change||Standard Error|Least Squares Mean
2566021|NCT02585778|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2566022|NCT02585778|Secondary|Percent Change From Baseline in Measured LDL-C at Week 12 - ITT Analysis|Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline measured LDL-C value on- or off-treatment at Week 12 (Measured LDL-C ITT population at Week 12).|||percent change||Standard Error|Least Squares Mean
2566023|NCT02585778|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment at Week 12 (ITT population at Week 12).|||percent change||Standard Error|Least Squares Mean
2566024|NCT02585778|Secondary|Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis|Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline measured LDL-C value on- or off-treatment (Measured LDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2566025|NCT02585778|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|Modified ITT population (mITT): all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2566026|NCT02585778|Primary|Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs)|Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days).|From Baseline up to 10 weeks after last study drug administration (maximum of 32 weeks)|Safety population: all randomized participants who received at least one dose or part of a dose of a study drug (treated).|||percentage of participants|||Number
2566027|NCT02585778|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2566028|NCT02585713|Secondary|Time to the First Event of the Composite Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)|Analyzed using the same methods described above for the primary endpoint.Time to the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE) is defined as the time from randomization to the date the patient experienced the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE).|Up to 3 months post-treatment||||months||95% Confidence Interval|Median
2566029|NCT02585713|Secondary|Composite Bleeding Rate: Major Bleed or a Clinically Relevant Non-major Bleed|A similar analysis as described for the primary safety analysis will be used. The rate (percentage) of patients experiencing major bleeding or a clinically relevant non-major bleed at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk.|Up to 6 months||||percentage of patients||95% Confidence Interval|Number
2566030|NCT02585713|Primary|6 Month Bleeding Rate|The rate (percentage) of patients experiencing major bleeding at 6 months from treatment initiation and its associated 95% confidence interval was estimated separately by treatment arm using a cumulative incidence function, treating death without bleeding as a competing risk.|Up to 6 months|Primary Analysis Population|||percentage of patients||95% Confidence Interval|Number
2566031|NCT02585700|Secondary|Geometric Mean Fold Rises (GMFRs) of MNT (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens.|The 3 influenza strains assessed were B/Massachusetts, H1/A/California an d H3/A/Texas|Pre- (Day 0) and post-vaccination (Day 21)|All vaccinated subjects who have valid post vaccination immunogenicity measures with no major protocol violations|||fold rise||95% Confidence Interval|Mean
2566033|NCT02585700|Secondary|Geometric Mean Fold Rises (GMFRs) of Serum (HAI) Antibodies (Post-vaccination / Pre-vaccination) for Each of the 3 Antigens.|The 3 influenza strains assessed were B/Massachusetts, H1/A/California an d H3/A/Texas|Pre- (Day 0) and post-vaccination (Day 21)|All vaccinated subjects who have valid post vaccination immunogenicity measures with no major protocol violations|||fold rise||95% Confidence Interval|Mean
2566034|NCT02585700|Secondary|Geometric Mean Titers (GMTs) of Serum Hemagglutination Inhibition (HAI) Antibodies Pre- (Day 0) and Post-vaccination (Day 21) for Each of the 3 Antigens|The 3 influenza strains assessed were B/Massachusetts, H1/A/California an d H3/A/Texas|Pre- (Day 0) and post-vaccination (Day 21)|All vaccinated subjects with no major protocol violations who have valid post vaccination immunogenicity measures|||Titers||95% Confidence Interval|Mean
2566035|NCT02585700|Secondary|Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine|A seroprotected subject was defined as a vaccinated subject who had a serum Hemagluttination Inhibition (HAI) titer ≥ 1:40. The 3 influenza strains assessed were B/Massachusetts, H1/A/California an d H3/A/Texas|Day 0 and Day 21 post vaccination|All vaccinated subjects who have valid post vaccination immunogenicity measures with no major protocol violations|||Participants|||Count of Participants
2566036|NCT02585700|Secondary|Number and Percentage of Seroconverted Subjects Against 3 Strains of Influenza Vaccine.|"Seroconversion is defined as a serum HAI titer meeting the following criteria:~pre-vaccination titer <1:10 and a post-vaccination titer ≥ 1:40 or~pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination measured on Day 21.~The 3 influenza strains assessed were B/Massachusetts, H1/A/California and H3/A/Texas"|Day 21|The analysis was conducted for subjects who were randomized and received a study vaccination|||Participants|||Count of Participants
2566037|NCT02585700|Primary|Number and Percentage of Subjects With Occurrence of Serious Adverse Events (SAE)||Over the entire study period (Day 90).|The analysis was conducted for subjects who were randomized and received a study vaccination|||Participants|||Count of Participants
2566038|NCT02585700|Primary|Number and Percentage of Subjects With Occurrence of Unsolicited Adverse Events|These data are presented broadly as number per group for the study. Please see AE reporting section for more specific details on AEs.|Within 21 days post vaccination|The analysis was conducted for subjects who were randomized and received a study vaccination|||Participants|||Count of Participants
2566039|NCT02585700|Primary|Number and Percentage of Subjects With Solicited Systemic Reactogenicity|Number of subjects reporting solicited systemic reactions (fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache) post-vaccination with study vaccine or Placebo|7-day period (Days 0-6) post-vaccination.|The analysis was conducted for subjects who were randomized and received a study vaccination|||Participants|||Count of Participants
2566040|NCT02585700|Primary|Number and Percentage of Subjects With Solicited Local Reactogenicity|Number of subjects reporting solicited local reactions (redness, swelling, induration, pain and tenderness) at the injection site post-vaccination with study vaccine or placebo|7-day period (Days 0-6) post-vaccination.|The analysis was conducted for subjects who were randomized and received a study vaccination|||Participants|||Count of Participants
2566041|NCT02585700|Primary|Number of Subjects With Immediate Adverse Events|Number of subjects with observed immediate adverse events, including allergic reaction or anaphylaxis, following administration of the study product.|30-minute post-vaccination period.|The analysis was conducted for subjects who were randomized and received a study vaccination|||Participants|||Count of Participants
2566042|NCT02585245|Primary|The Percent of Participants Identified With Malnutrition Using the NRS 2002 and ThedaCare Nutrition Risk Screen|Sensitivity: True Positives/ (True Positives +False Negatives) Specificity: True Negatives/ (True Negatives + False Positives)|24 hr within admission to the hospital||||percentage of participants||95% Confidence Interval|Number
2566043|NCT02584998|Secondary|The Number of Participants Who Received Any Colorectal Cancer Screening Test in the 6-month Period After Enrollment Into the Study.|The receipt of any colorectal cancer screening test in the 6-month period after enrollment into the study. For patients in the usual care arm, 6 months was counted from the date of mailed letter to arms 2 and 3 within that block of participants.|6 months|We analyzed all randomized patients to identify any CRC screening at 6 months from mailed screening invitation.|||Participants|||Count of Participants
2566044|NCT02584998|Primary|The Number of Participants Who Completed the Mailed FIT Test Screening Within 6 Months|The completion rate of mailed FIT test within 6 months of the mailing of the screening invitation. The absence of FIT result in the electronic medical record (CRPS) will be considered a failure to complete the FIT test|6 months|For this outcome, we just analyzed patients in Arm 3 (n=261), the mailed-FIT kit, arm, as they were the only patients eligible to return a mailed fit kit.|||Participants|||Count of Participants
2566045|NCT02584959|Secondary|Mean Change in Angioedema Quality of Life Questionnaire Scores From Baseline to Week 13|The AE-QoL is a questionnaire on the quality of life of patients suffering from recurrent angioedema. It consists of 17 specific questions that are associated with work, physical activity, free time, social relations, and food. Each of the 17 questions has a five-point response scale ranging from 1 (Never) to 5 (Very Often). The AE-QoL consists of 4 dimensions (functioning=4 questions(qns) fatigue/mood=5 qns, fears/shame=6 qns, nutrition=2 qns) and a total score (all 17 questions).All scores were calculated by using the following formula: (Σ items - min Σ items / max Σ items - min Σ items) x 100. Σ items=sum of response by participant, min Σ items=minimum response possible, max Σ items=maximum response possible. Scores range from 0 to 100 , with higher scores indicating greater impairment. Absolute change calculated as visit score at week 13 minus score at baseline per period.|Baseline to week 13 for treatment period 1 and 2||||Mean change in AE-QoL scores||Standard Deviation|Mean
2566046|NCT02584959|Secondary|Participant Experience With Self-administration: Better Long-term Option and Preferred Administration|"The self-administration survey includes the number of visits needed for participants to be able to self-administer investigational product with confidence and all participants could self-administer without supervision.~Visit 28 summarizes treatment period 1 of the experimental/experimental arm and treatment periods 1 and 2 of the experimental/placebo arm and the placebo/experimental arm. Visit 28b summarizes treatment period 2 of the experimental/experimental arm."|Week 14 for treatment period 1 and 2|Visit 28b summarizes only treatment period 2 of the Experimental/Experimental arm. Therefore no participants were analyzed in the placebo group.|||Participants|||Count of Participants
2566047|NCT02584959|Secondary|Participant Experience With Self-administration: How Many Visits for Confidence With Self-administration|"The self-administration survey includes the number of visits needed for participants to be able to self-administer investigational product with confidence and all participants could self-administer without supervision.~Visit 28 summarizes treatment period 1 of the experimental/experimental arm and treatment periods 1 and 2 of the experimental/placebo arm and the placebo/experimental arm. Visit 28b summarizes treatment period 2 of the experimental/experimental arm."|Week 14 for treatment period 1 and 2|Visit 28b summarizes only treatment period 2 of the Experimental/Experimental arm. Therefore no participants were analyzed in the placebo group.|||Number of visits||Standard Deviation|Mean
2566048|NCT02584959|Secondary|Participant Experience With Self-administration: Overall Experience With the Syringe|Self-administration survey with questions about the overall experience with the syringe was assessed in week 14 (visit 28 and 28b). Visit 28 summarizes treatment period 1 of the experimental/experimental arm and treatment periods 1 and 2 of the experimental/placebo arm and the placebo/experimental arm. Visit 28b summarizes treatment period 2 of the experimental/experimental arm.|Week 14 for treatment period 1 and 2|Visit 28b summarizes only treatment period 2 of the Experimental/Experimental arm. Therefore no participants were analyzed in the placebo group.|||Participants|||Count of Participants
2566049|NCT02584959|Secondary|Assess Disease Activity as Measured by the Angioedema Activity Score (AAS) Normalized Per Month|Disease activity was measured using a 98-day Angioedema Activity Score (AAS). The AAS collects information of disease activity in the last 24 hours. The following items are assessed: experience of swelling, severity of the swelling, timing of the swelling, extent of discomfort due to the swelling, extent that the swelling caused limitations in daily life, and feelings of being disfigured by the swelling. The instrument uses a binary response option for the first item and a three-point response scale for the 5 items thereafter. The daily AAS was the sum of the AAS items per day. Total daily ASS scores range between 0 and 15 points. Higher values stand for higher disease activity. The normalized 98-day AAS per month for a participant is calculated by (the sum of daily AAS within a treatment period/the number of days that a subject has AAS records within the treatment period)*30.4.|Weeks 1 to 14 for treatment period 1 and 2|Data were not collected for the Experimental/Experimental Arm for this outcome measure and this represents the full analysis set.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2566050|NCT02584959|Secondary|PK Parameters: Tmax for Complement C4 Concentrations (Placebo Group)|tmax=time of maximum observed plasma concentration. Participant wise data was reported for this outcome.|Within 15 min prior dosing at week 1, week 2, week 8, week 16, week 24, week 27/28 and 48 (± 3) hours after dose in week 27/28 in period 1 and 2 and in addition 24 (±3) hours, 72 (±6) hours and 96 (±6) hours post dose in week 28 for period 2.|All participants included who have taken at least one dose of investigational product and for whom the primary PK data are considered sufficient and interpretable. No summary analysis was done and participant wise data are reported.|||mg/L|||Number
2566051|NCT02584959|Secondary|PK Parameters: Tmax|tmax=time of maximum observed plasma concentration|Within 15 min prior dosing at week 1, week 2, week 8, week 16, week 24, week 27/28 and 48 (± 3) hours after dose in week 27/28 in period 1 and 2 and in addition 24 (±3) hours, 72 (±6) hours and 96 (±6) hours post dose in week 28 for period 2.|"All participants included who have taken at least one dose of investigational product and for whom the primary PK data are considered sufficient and interpretable.~For Complement C4 Concentration no summary analysis was done for participants in the placebo group and participant wise data for 2 participants are reported in Outcome measure #19."|||hours||Standard Deviation|Mean
2566052|NCT02584959|Secondary|PK Parameters: Cmax and Cmin for Complement C4 Concentrations (Treatment Placebo)|"Cmax=maximum observed plasma concentration and Cmin=minimum observed plasma concentration.~Participant wise data was reported for this outcome."|Within 15 min prior dosing at week 1, week 2, week 8, week 16, week 24, week 27/28 and 48 (± 3) hours after dose in week 27/28 in period 1 and 2 and in addition 24 (±3) hours, 72 (±6) hours and 96 (±6) hours post dose in week 28 for period 2.|All participants included who have taken at least one dose of investigational product and for whom the primary PK data are considered sufficient and interpretable. No summary analysis was done and participant wise data are reported.|||mg/L|||Number
2566053|NCT02584959|Secondary|PK Parameters: Cmax and Cmin for Complement C4 Concentrations (Treatment C1 INH)|Cmax=maximum observed plasma concentration and Cmin=minimum observed plasma concentration|Within 15 min prior dosing at week 1, week 2, week 8, week 16, week 24, week 27/28 and 48 (± 3) hours after dose in week 27/28 in period 1 and 2 and in addition 24 (±3) hours, 72 (±6) hours and 96 (±6) hours post dose in week 28 for period 2.|All participants included who have taken at least one dose of investigational product and for whom the primary PK data are considered sufficient and interpretable.|||mg/L||Standard Deviation|Mean
2566054|NCT02584959|Secondary|PK Parameters: Cmax and Cmin for C1 INH Antigen Concentrations|Cmax=maximum observed plasma concentration and Cmin=minimum observed plasma concentration|Within 15 min prior dosing at week 1, week 2, week 8, week 16, week 24, week 27/28 and 48 (± 3) hours after dose in week 27/28 in period 1 and 2 and in addition 24 (±3) hours, 72 (±6) hours and 96 (±6) hours post dose in week 28 for period 2|All participants included who have taken at least one dose of investigational product and for whom the primary PK data are considered sufficient and interpretable.|||µg/mL||Standard Deviation|Mean
2566055|NCT02584959|Secondary|PK Parameters: Cmax and Cmin for Functional C1 INH Binding Activity|Cmax=maximum observed plasma concentration and Cmin=minimum observed plasma concentration|Within 15 min prior dosing at week 1, week 2, week 8, week 16, week 24, week 27/28 and 48 (± 3) hours after dose in week 27/28 in period 1 and 2 and in addition 24 (±3) hours, 72 (±6) hours and 96 (±6) hours post dose in week 28 for period 2.|All participants included who have taken at least one dose of investigational product and for whom the primary PK data are considered sufficient and interpretable.|||mU/mL||Standard Deviation|Mean
2566092|NCT02584686|Secondary|Global Assessment Question (GAQ)|"Assessment of the effect of treatment by asking Has the treatment you have been taking improved your erectile function?. The number answering Yes in both the treatment and control groups are calculated."|1 month||||participants|||Number
2566093|NCT02584686|Secondary|SHIM Score After Treatment|Assessment of the Sexual Health Inventory for men (SHIM) questionnaire before treatment for both groups. It is a questionnaire that helps asses if the patient has erectile dysfunction (ED) and assesses its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED.|1 month||||units on SHIM scale||Standard Deviation|Mean
2566056|NCT02584959|Secondary|PK Parameters: AUC (0-96) and AUC (0-t) for Complement C4 Concentrations (Treatment Placebo)|AUC(0-96)=area under the plasma concentration-time curve from time zero to last measurable concentration; AUC(0-t)=area under the plasma concentration-time curve from time zero extrapolated to the end of the dosing interval tau, where tau is approximately 84 hours (ie, average of every 3 or 4 days) AUC(0-96) = AUC(0-tau). Participant wise data was reported for this outcome.|Within 15 min prior dosing at week 1, week 2, week 8, week 16, week 24, week 27/28 and 48 (± 3) hours after dose in week 27/28 in period 1 and 2. In addition 24 (±3) hours, 72 (±6) hours and 96 (±6) hours post dose in week 28 for period 2.|All participants included who have taken at least one dose of investigational product and for whom the primary PK data are considered sufficient and interpretable. No summary analysis was done and participant wise data are reported.|||mg*h/L|||Number
2566057|NCT02584959|Secondary|PK Parameters: AUC (0-96) and AUC (0-t) for Complement C4 Concentrations (Treamtment C1 INH)|AUC(0-96)=area under the plasma concentration-time curve from time zero to last measurable concentration; AUC(0-t)=area under the plasma concentration-time curve from time zero extrapolated to the end of the dosing interval tau, where tau is approximately 84 hours (ie, average of every 3 or 4 days) AUC(0-96) = AUC(0-tau).|Within 15 min prior dosing at week 1, week 2, week 8, week 16, week 24, week 27/28 and 48 (± 3) hours after dose in week 27/28 in period 1 and 2. In addition 24 (±3) hours, 72 (±6) hours and 96 (±6) hours post dose in week 28 for period 2.|All participants included who have taken at least one dose of investigational product and for whom the primary PK data are considered sufficient and interpretable.|||mg*h/L||Standard Deviation|Mean
2566058|NCT02584959|Secondary|PK Parameters: AUC (0-96) and AUC (0-t) for C1 INH Antigen Concentrations|AUC(0-96)=area under the plasma concentration-time curve from time zero to last measurable concentration; AUC(0-t)=area under the plasma concentration-time curve from time zero extrapolated to the end of the dosing interval tau, where tau is approximately 84 hours (ie, average of every 3 or 4 days) AUC(0-96) = AUC(0-tau).|Within 15 min prior dosing at week 1, week 2, week 8, week 16, week 24, week 27/28 and 48 (± 3) hours after dose in week 27/28 in period 1 and 2. In addition 24 (±3) hours, 72 (±6) hours and 96 (±6) hours post dose in week 28 for period 2.|All participants included who have taken at least one dose of investigational product and for whom the primary PK data are considered sufficient and interpretable.|||mcg*h/mL||Standard Deviation|Mean
2566059|NCT02584959|Secondary|PK Parameters: AUC (0-96) and AUC (0-t) for Functional C1 INH Binding Activity|AUC(0-96)=area under the plasma concentration-time curve from time zero to last measurable concentration; AUC(0-t)=area under the plasma concentration-time curve from time zero extrapolated to the end of the dosing interval tau, where tau is approximately 84 hours (ie, average of every 3 or 4 days) AUC(0-96) = AUC(0-tau).|Within 15 min prior dosing at week 1, week 2, week 8, week 16, week 24, week 27/28 and 48 (± 3) hours after dose in week 27/28 in period 1 and 2. In addition 24 (±3) hours, 72 (±6) hours and 96 (±6) hours post dose in week 28 for period 2.|All participants included who have taken at least one dose of investigational product and for whom the primary PK data are considered sufficient and interpretable.|||mU*h/mL||Standard Deviation|Mean
2566060|NCT02584959|Secondary|Number of Patients With Positive Anti-C1 INH Antibodies|Anti-C1 INH antibodies were measured during study time.|Weeks 1 to 14 for treatment period 1 and 2||||Participants|||Count of Participants
2566061|NCT02584959|Secondary|Number of Participants With Injection Site Reactions|Injection site reactions (Erythema, Swelling, Cutaneous pain, Burning sensation, Itching/Pruritus, Warm sensation) were recorded on a designated eCRF page by the site personnel who monitored the local reaction for 1 hour after IP administration 5 times during each treatment period.|Weeks 1 to 14 for treatment period 1 and 2||||Participants|||Count of Participants
2566062|NCT02584959|Secondary|Number of Patients With Adverse Events (AEs)|Treatment-emergent adverse events (TEAE) were counted by the treatment most recently taken when the event occurred. Participants were counted once per category per treatment.|Weeks 1 to 14 for treatment period 1 and 2||||Participants|||Count of Participants
2566063|NCT02584959|Secondary|Response to Icatibant When Administered for an Acute Attack|The number of Acute Hereditary Angioedema Attacks that required Icatibant as acute therapy is presented by the number of Icatibant injections.|Weeks 1 to 14 for treatment period 1 and 2|For treatment with C1 INH (Overall treatment with C1 INH group) all participants who received C1 INH in each of the randomized arms (experimental/placebo, placebo/experimental and experimental/experimental) are included.|||Attacks requiring Icatibant|Attacks requiring Icatibant||Count of Units
2566064|NCT02584959|Secondary|Number of Angioedema Attacks Requiring Acute Treatment|Angioedema attacks were normalized per month.|Weeks 1 to 14 for treatment period 1 and 2|Data were not collected for the Experimental/Experimental Arm for this outcome measure and this represents the full analysis set.|||Number of attacks||95% Confidence Interval|Least Squares Mean
2566065|NCT02584959|Secondary|Number of Attack-free Days|Attack free days were normalized per month.|Weeks 1 to 14 for treatment period 1 and 2|Data were not collected for the Experimental/Experimental Arm for this outcome measure and this represents the full analysis set.|||Days||95% Confidence Interval|Least Squares Mean
2566066|NCT02584959|Secondary|Cumulative Attack Severity|"Severity of the angioedema attack sign/symptom was characterized as None: no symptom; Mild: noticeable symptom but easily tolerated by the participant and did not interfere with routine activities; Moderate: symptom interfered with the participant's ability to attend school or participate in family life and social/recreational activities; Severe: symptom significantly limited the participant's ability to attend school or participate in family life and social/recreational activities.~Symptom severity score was assigned as Mild = 1, Moderate = 2 and Severe = 3. Cumulative attack severity score was the sum of the maximum symptom severity scores recorded for each angioedema attack in a treatment period.~Cumulative attack-severity score normalized per month [(raw score/number of days of participation in that treatment period)*30.4] was reported here. Cumulative attack-severity score normalized per month ranged from 0 to 19.83 and higher scores represent worse symptoms."|Weeks 1 to 14 for treatment period 1 and 2|Data were not collected for the Experimental/Experimental Arm for this outcome measure and this represents the full analysis set.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2566094|NCT02584686|Secondary|SHIM Score Before Treatment|Assessment of the Sexual Health Inventory for men (SHIM) questionnaire before treatment for both groups. It is a questionnaire that helps asses if the patient has erectile dysfunction (ED) and assesses its degree. Results range from 1 to 25. A score of 1-7 denotes Severe ED, 8-11 Moderate ED, 12-16, Mild to Moderate ED, 17-21 Mild ED, 22-25 No ED.|Baseline||||units on the SHIM scale||Standard Deviation|Mean
2566067|NCT02584959|Secondary|Proportion of Participants Meeting at Least a 50% Reduction in NNA (Normalized Number of Angioedema Attacks) During the Experimental Injection Treatment Period Relative to the Pre-treatment Assessment.|The angioedema attacks were recorded in the electronic patient diary. The investigator completed a separate angioedema eCRF for each attack based on the review of the patients diary. Time-Normalized Number of Attacks was expressed as the number of attacks per month (ie, 30.4 days) of exposure. NNA = 30.4 x (number of attacks during treatment period) / (days of treatment period).|Weeks 1 to 14 for treatment period 1 and 2|Full analysis set from the crossover sequences (Experimental/Placebo arm and Placebo/Experimental arm) was used for analysis of this outcome measure.Participants with zero attacks in the placebo period were excluded because a percent reduction could not be calculated. Analysis was done on participants with pretreatment and post-treatment NNA values|||Participants|||Count of Participants
2566068|NCT02584959|Secondary|Proportion of Participants Meeting at Least a 50% Reduction in NNA (Normalized Number of Angioedema Attacks) During the Experimental Injection Treatment Period Relative to the Placebo Period Excluding the First 2 Weeks of Each Treatment Period.|The angioedema attacks were recorded in the electronic patient diary. The investigator completed a separate angioedema eCRF for each attack based on the review of the patients diary. Time-Normalized Number of Attacks was expressed as the number of attacks per month (ie, 30.4 days) of exposure. NNA = 30.4 x (number of attacks during treatment period) / (days of treatment period).|Weeks 3 to 14 for treatment period 1 and 2|Analysis done on participants from the crossover sequences (Experimental/Placebo, Placebo/Experimental) who were dosed in both treatment periods. As the measure is implicitly a within subject comparison of the two arms the full analysis set is reported here. Participants with 0 attacks in the placebo period were excluded as %-reduct. not calculated|||Participants|||Count of Participants
2566069|NCT02584959|Secondary|Time-Normalized Number of Attacks (NNA) for Participants During Each Treatment Period Excluding the First 2 Weeks.|The angioedema attacks were recorded in the electronic patient diary. The investigator completed a separate angioedema eCRF for each attack based on the review of the patients diary. Time-normalized number of angioedema attacks was expressed as the number of attacks per month (ie, 30.4 days) of exposure. NNA=30.4 * (number of attacks during treatment period) / (days of treatment period).|Weeks 3 to 14 for treatment period 1 and 2|Data were not collected for the Experimental/Experimental Arm for this outcome measure and this represents the full analysis set.|||Number of Attacks||95% Confidence Interval|Least Squares Mean
2566070|NCT02584959|Secondary|Proportion of Participants Meeting at Least a 50% Reduction in NNA (Normalized Number of Angioedema Attacks) During the Experimental Injection Treatment Period Relative to the Placebo Period.|The angioedema attacks were recorded in the electronic patient diary. The investigator completed a separate angioedema eCRF for each attack based on the review of the patients diary. Time-Normalized Number of Attacks was expressed as the number of attacks per month (ie, 30.4 days) of exposure. NNA = 30.4 x (number of attacks during treatment period) / (days of treatment period).|Weeks 1 to 14 for treatment period 1 and 2|Analysis done on participants from the crossover sequences (Experimental/Placebo, Placebo/Experimental) who were dosed in both treatment periods. As the measure is implicitly a within subject comparison of the two arms the full analysis set is reported here. Participants with 0 attacks in the placebo period were excluded as %-reduct. not calculated|||Participants|||Count of Participants
2566071|NCT02584959|Primary|Time-Normalized Number of Attacks (NNA) for Participants During a Treatment Period|"The angioedema attacks were recorded in the electronic patient diary. The investigator completed a separate angioedema eCRF for each attack based on the review of the patients diary.~Time-normalized number of angioedema attacks was expressed as the number of attacks per month (ie, 30.4 days) of exposure. NNA=30.4 * (number of attacks during treatment period) / (days of treatment period)."|Weeks 1 to 14 for treatment period 1 and 2|Data were not collected for the Experimental/Experimental Arm for this outcome measure and this represents the full analysis set.|||Number of attacks||95% Confidence Interval|Least Squares Mean
2566072|NCT02584855|Secondary|Double-Blind Withdrawal Period: Change From Baseline in Physical Functioning Assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI)|"The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.Least Square (LS) mean calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment group, baseline measure, geographic region, cDMARD use, treatment week, baseline measure-by-treatment week interaction term, and treatment week-by-treatment interaction term as fixed factors.~Participants were randomized only if they met randomization criteria which was at anytime from week 36 to week 64."|Baseline, 40 Weeks from Double Blind Randomization (Week 36 to 64)|All participants who received at least one dose of study drug had a baseline and post baseline measure in the Double-Blind Withdrawal Period.|||score on a scale||Standard Error|Least Squares Mean
2566073|NCT02584855|Secondary|Double-Blind Withdrawal Period: Time to Re-Gain MDA Following Relapse in MDA|MDA is achieved if 5 of 7 outcome measures are fulfilled: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or BSA ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1. Time to first response (in weeks) = (date of first response - date of first injection of study treatment in the Relapse Period + 1)/7.|Relapse in MDA After Double Blind Randomization through Week 104 (or Early Termination)|All participants who received at least one dose of study drug and relapsed in MDA After Double Blind Randomization Until Re-Gain MDA. Censored participants were: Ixekizumab= 3 and Placebo= 3.|||weeks||95% Confidence Interval|Median
2566095|NCT02584686|Secondary|EHS After Treatment|"Clinical assessment of the Erection hardness score (EHS) in both groups after ICI after 2 weeks.~The Erection Hardness Score (EHS) is designed to measure the rigidity of erection. It ranges from 0 (no erection) to 4 (Fully rigid and hard erection).~0 - Penis does not enlarge.~- Penis is larger, but not hard.~- Penis is hard, but not hard enough for penetration.~- Penis is hard enough for penetration, but not completely hard.~- Penis is completely hard and fully rigid. The average score is reported for each group."|2 weeks||||units on EHS scale||Standard Deviation|Mean
2566074|NCT02584855|Secondary|Open-Label Treatment Period: Time to Achieve Randomization Criteria (Meeting MDA for 3 Consecutive Months Over 4 Consecutive Visits)|"Time to meeting MDA for 3 Consecutive Months Over 4 Consecutive Visits. Time to first response (in weeks) = [(date of first response - date of first injection of study treatment in the Open-Label Treatment Period)+1]/7.~Open-Label Treatment Period ended at the time when a participant was randomized so the end time was not the same for all participants. Participants were randomized only if they met randomization criteria which was at anytime from week 36 to week 64."|Open Label Baseline through Double-Blind Randomization (Week 36 to 64)|All participants who received at least one dose of study drug in initial open-label treatment period. Censored participants were 239.|||weeks||95% Confidence Interval|Median
2566075|NCT02584855|Secondary|Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Entheseal Points|Tender entheseal points was based on the assessment of the 18 entheseal points. Loss of Response = Not Meeting less than or equal to 1 Tender Entheseal Point. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.|Double Blind Randomization through Week 104 (or Early Termination or Relapse)|All participants who received at least one dose of study drug in the randomized withdrawal Intent-to-Treat Population who had tender Entheseal Point <= 1 at time of randomization. Censored participants: Ixekizumab= 58 and Placebo= 58.|||weeks||95% Confidence Interval|Median
2566076|NCT02584855|Secondary|Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Health Assessment Questionnaire-Disability Index (HAQ-DI)|"The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.~Loss of Response = Not Meeting less than or equal to 0.5 HAQ-DI. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7."|Double Blind Randomization through Week 104 (or Early Termination or Relapse)|All participants who received at least one dose of study drug in the randomized withdrawal Intent-to-Treat population Who had HAQ-DI <= 0.5 at Time of randomization. Censored participants: Ixekizumab= 55 and Placebo=53.|||weeks||95% Confidence Interval|Median
2566077|NCT02584855|Secondary|Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Patients Global Assessment of Disease Activity (PatGA) Visual Analog Scale (VAS) Score|"Participants scored their overall assessment of their psoriatic arthritis (PsA) activity on a 0 to 100 mm horizontal VAS. The scale ranged from 0 (no disease activity) to 100 (extremely active disease activity). The scores were measured to the nearest millimeter from the left.~Loss of Response = Not Meeting less than or equal to 20 PatGA. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7."|Double Blind Randomization through Week 104 (or Early Termination or Relapse)|All participants who received at least one dose of study drug in the randomized withdrawal Intent-to-Treat population Who had PatGA VAS <= 20 at time of randomization. Censored participants: Ixekizumab= 57 and Placebo=18.|||weeks||95% Confidence Interval|Median
2566078|NCT02584855|Secondary|Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Pain Visual Analog Scale (VAS) Score|The pain VAS is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two endpoints whereby the respondent places a mark on the line to indicate his or her response The scale ranges from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Loss of Response = Not Meeting less than or equal to 15 Pain VAS. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7.|Double Blind Randomization through Week 104 (or Early Termination or Relapse)|All participants who received at least one dose of study drug in the randomized withdrawal Intent-to-Treat Population who had Pain VAS <= 15 at time of randomization. Censored participants: Ixekizumab=42 and Placebo= 7.|||weeks||95% Confidence Interval|Median
2566079|NCT02584855|Secondary|Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: BSA|"BSA is an investigator evaluated measure, where the percentage of involvement of psoriasis on each participant's BSA is assessed. BSA was measured on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb. Loss of Response = Not meeting less than or equal to 3% BSA.~Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7."|Double Blind Randomization through Week 104 (or Early Termination or Relapse)|All participants who received at least one dose of study drug in the randomized Withdrawal Intent-to-Treat Population who had BSA <= 3% at time of randomization. Censored participants: Ixekizumab=70 and Placebo= 59.|||weeks||95% Confidence Interval|Median
2566080|NCT02584855|Secondary|Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Psoriasis Area and Severity Index (PASI)|"The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.~Loss of Response = Not Meeting less than or equal to 1 PASI total score. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7."|Double Blind Randomization through Week 104 (or Early Termination or Relapse)|All participants who received at least one dose of study drug in the randomized withdrawal intent-to-treat population Who had PASI <= 1 at time of randomization. Censored participants: Ixekizumab = 64 and Placebo = 43.|||weeks||95% Confidence Interval|Median
2566152|NCT02583425|Primary|The Number of Headache Hours in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches)||28 days Baseline period and 28 days of Treatment period (Total 56 days)||||Hours||Standard Deviation|Mean
2566081|NCT02584855|Secondary|Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Swollen Joint Count 66 (SJC)|"SJC is the number of swollen joints determined for each participant by examination of 66 joints. SJC possible values range from 0 to 66. A lower SJC indicated less joints with swelling. A higher SJC indicated more joints with swelling. Swelling was defined as palpable fluctuating synovitis of the joint.~Loss of Response = Not Meeting less than or equal to 1 SJC. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7."|Double Blind Randomization through Week 104 (or Early Termination or Relapse)|All participants who received at least one dose of study drug in the randomized withdrawal Intent-to-Treat population who had swollen joint counts <= 1 at time of randomization. Censored participants: Ixekizumab= 61 and Placebo = 40.|||weeks||95% Confidence Interval|Median
2566082|NCT02584855|Secondary|Double-Blind Withdrawal Period: Time to Loss of Response in Each Individual Component of MDA: Tender Joint Count 68 (TJC)|"TJC is the number of tender and painful joints determined for each participant by examination of 68 joints.TJC possible values range from 0 to 68. A lower TJC indicated less number of joints with tenderness. A higher TJC indicated more joint tenderness. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy.~Loss of Response = Not Meeting less than or equal to 1 TJC. Time to loss of response (in weeks) = (date of loss of response - date of first injection of randomized dose of study treatment in the Randomized Double-Blind Withdrawal Period + 1)/7."|Double Blind Randomization through Week 104 (or Early Termination or Relapse)|All participants who received at least one dose of study drug in the randomized withdrawal Intent-to-Treat Population who had tender joint counts <= 1 at time of randomization. Censored participants: Ixekizumab= 29 and Placebo= 16.|||weeks||95% Confidence Interval|Median
2566083|NCT02584855|Secondary|Double-Blind Withdrawal Period: Percentage of Participants Who Relapse in MDA|Relapsed participants are defined as participants no longer meeting Coates criteria for MDA. MDA is achieved if 5 of 7 outcome measures are fulfilled: TJC ≤1; SJC ≤1; psoriasis activity and severity index (PASI total score) ≤1 or body surface area (BSA) ≤3; participant pain VAS score of ≤15; participant global disease activity VAS score of ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1.|Double Blind Randomization through Week 104 (or Early Termination or Relapse)|All participants who received at least one dose of study drug in randomized withdrawal Intent-to-Treat population.|||percentage of participants||95% Confidence Interval|Number
2566084|NCT02584855|Primary|Double-Blind Withdrawal Period: Time to Relapse (No Longer Meeting Coates Criteria for Minimal Disease Activity [MDA])|Relapse is loss of MDA response. MDA is achieved if 5 of 7 outcome measures are fulfilled:TJC ≤1;SJC ≤1;psoriasis activity & severity index(PASI total score) ≤1 or body surface area(BSA) ≤3;participant pain VAS score of ≤15;participant global disease activity VAS score of ≤20;HAQ-DI score ≤0.5;and tender entheseal points ≤1.Participants met the randomization criteria if they had MDA for 3 consecutive months over 4 consecutive visits.Time-to relapse was calculated in weeks as follows:((Date of Relapse) - Date of first injection of randomized study treatment in period 3)+1) divided by 7.If the date of first dose is missing,the date of randomization will be used.Participants completing Period 3 will be censored at date of completion(the date of the last scheduled visit in the period).Participants without a date of completion or discontinuation for Period 3 will be censored at latest non-missing date out of the following dates:date of last dose & date of last attended visit in Period 3.|Double Blind Randomization through Week 104 (or Early Termination or Relapse)|All participants who received at least one dose of study drug in randomized withdrawal Intent-to-Treat population. Censored participants were Ixekizumab = 49 and Placebo =12.|||Weeks||95% Confidence Interval|Median
2566085|NCT02584790|Secondary|The Sensitivity, Specificity, Positive Predicted Valve and Negative Predicted Valve of Detecting Mucosal Residual NPC Using NBI Suspicious/ Non Suspicous Pattern|"Non suspicious pattern = grade A + grade B Suspicious pattern = grade C + D~The sensitivity, specificity, positive predicted valve and negative predicted valve of detecting mucosal residual NPC using NBI suspicious/ non suspicous pattern can be thus calculated."|Post-radiotherapy eight weeks|NBI non suspicious pattern = 36 NBI suspcious pattern = 4 Total = 40|||Percentage of participants|||Number
2566086|NCT02584790|Secondary|Assocication of Residual NPC With NBI Non Suspicious Pattern Group and NBI Suspicious Pattern Group|"Non suspicious pattern = grade A + grade B Suspicious pattern = grade C + D~The sensitivity, specificity, positive predicted valve and negative predicted valve of detecting mucosal residual NPC using NBI suspicious/ non suspicous pattern can be thus calculated."|Post-radiotherapy eight weeks|NBI non suspicious pattern = 36 NBI suspcious pattern = 4 Total = 40|||Participants|||Count of Participants
2566087|NCT02584790|Primary|Positive Nasopharynx Biopsy Results Detected by NBI System in Those Post-radiotherapy 8th Week NPC Patient|"4 grading of NBI vessel patterns can be identified in those post-radiotherapy 8 weeks NPC patients.~Grade A: normal vessel size and length, regular pattern Grade B: normal vessel size, short, regular spiderweb like pattern Grade C: irregular vessel size and length, distorted and irregular pattern Grade D: thickened vessel size, elongated, distorted, and earthworm pattern"|Post-radiotherapy 8th week||||participants|||Number
2566088|NCT02584686|Secondary|SEP-Q3 Question After Treatment|"Number of patients answering Yes to the Sexual Encounter Profile question 3 (SEP-Q3: Did your erection last long enough for you to have successful intercourse?) after treatment.~This analysis compares the number of patients who were able to maintain their erection long enough to complete sexual intercourse after treatment in the (BTX) A group versus the Saline group."|1 month||||participants|||Number
2566089|NCT02584686|Secondary|SEP-Q3 Question Before Treatment|"Number of patients answering Yes to the Sexual Encounter Profile question 3 (SEP-Q3: Did your erection last long enough for you to have successful intercourse?) before treatment."|Baseline||||participants|||Number
2566090|NCT02584686|Secondary|SEP-Q2 Question After Treatment|"Number of patients answering Yes to the Sexual Encounter Profile question 2 (SEP-Q2: Were you able to insert your penis into your partner's vagina?) after treatment.~This analysis compares the number of patients who were able to perform vaginal intromission (insert the penis into the partner's vagina) after treatment in the (BTX) A group versus the Saline group."|1 month||||participants|||Number
2566096|NCT02584686|Secondary|EHS Before Treatment|"Clinical assessment of the Erection hardness score (EHS) in both groups after ICI at baseline.~The Erection Hardness Score (EHS) is designed to measure the rigidity of erection. It ranges from 0 (no erection) to 4 (Fully rigid and hard erection).~0 - Penis does not enlarge.~- Penis is larger, but not hard.~- Penis is hard, but not hard enough for penetration.~- Penis is hard enough for penetration, but not completely hard.~- Penis is completely hard and fully rigid. The average score is reported for each group."|Baseline||||units on EHS scale||Standard Deviation|Mean
2566097|NCT02584686|Primary|Cavernosal Artery Mean PSV After Treatment|Cavernosal artery mean peak systolic velocity (PSV) after treatment, on color Doppler examination, in the patient and control groups.|2 weeks||||cm/s||Standard Deviation|Mean
2566098|NCT02584686|Primary|Cavernosal Artery Mean PSV Before Treatment|Baseline mean Peak systolic velocity (PSV) in the Cavernosal arteries, on color Doppler examination, in the patient and control groups, before treatment.|Baseline||||cm/s||Standard Deviation|Mean
2566099|NCT02584673|Secondary|Number of Times Needle Needs Repositioning||Immediately following intervention (within 2 hours)|This data was not collected||||||
2566100|NCT02584673|Secondary|Number of Attempts|Number of instrument pricks before target is reached|Immediately following intervention (within 2 hours)|This data was not collected||||||
2566101|NCT02584673|Secondary|Clinician Rating of the Device||Immediately following intervention (within 2 hours)|This data was not collected||||||
2566102|NCT02584673|Primary|Time Needed to Correctly Insert the Arterial or Midline Catheter.||Immediately following intervention (within 2 hours)||||Seconds||Standard Deviation|Mean
2566103|NCT02584660|Secondary|Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire|The Satisfaction to Site-of-Care Questionnaire (standard-of-care versus early discharge on rivaroxaban therapy) was administered after 7 days on anticoagulant therapy. Satisfaction to Site-of-Care (hospitalization versus home care) rates the participant's level of satisfaction to care and location with care received as well as preference to location of care provided. Participants rated the 3 items of this scale of 1=Very satisfied; 2=Quite satisfied; 3=Neither; 4=Quite dissatisfied; and 5=Very dissatisfied for satisfaction questions and for the 1 preference question responses included 1=In the hospital; 2=In the community; and 3=No preference. Higher score indicates more level of satisfaction.|Day 7|The safety population included all randomized participants who took at least 1 dose of study drug.|||Percentage of participants|||Number
2566104|NCT02584660|Secondary|Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)|ACTS is defined as a validated measure for assessing treatment satisfaction. The ACTS comprised of 2 subscales: Burdens (13 items: Item 1 to 13 [how much of limitation from taking part in vigorous physical activities, limitation from usual activities, bothered by bruising, bothered to avoid other medicines, limitation to diet, daily hassle, occasional hassle, difficult to follow treatment, time-consuming, worrying, frustrating, burden, negative impact on life respectively) and Benefits (4 items: Items 14 to 17 for evaluating confidence, reassurance, satisfaction, positive impact respectively) as a result of anti-clot treatment. The treatment experience scores ranged from 'Not at all' to 'Extremely' on a 5-point Likert scale (psychometric rating); higher scores indicate greater satisfaction with treatment.|Day 90|The safety population included all randomized participants who took at least 1 dose of study drug.|||Percentage of participants|||Number
2566105|NCT02584660|Secondary|Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason|Mean combined duration of Initial and subsequent ED Stay and hospitalization for any reason within 30 and 90 days from randomization was analyzed.|Up to 30 and 90 Days|The ITT included all participants who were randomized into the study.|||Days||Standard Deviation|Mean
2566106|NCT02584660|Secondary|Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding|Percentage of participants of unplanned hospitalization for VTE symptoms or bleeding-related hospital or physician visits were analyzed.|Up to 7, 14, 30 and 90 Days|The ITT included all participants who were randomized into the study.|||Percentage of Participants|||Number
2566107|NCT02584660|Secondary|Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death|Reoccurrence of symptomatic, objectively confirmed VTE, defined as recurrent pulmonary embolism (PE) or new or recurrent deep vein thrombosis (DVT) (including symptomatic upper extremity DVT) or VTE related death were analyzed.|Up to 7, 14, 30, and 90 Days|The ITT included all participants who were randomized into the study.|||Percentage of participants|||Number
2566108|NCT02584660|Primary|Mean Duration of Hospitalization|Mean number of days of initial inpatient hospitalization (beginning from randomization to discharge from the hospital) plus any subsequent hospitalization(s) related to bleeding and/or venous thromboembolism (VTE) events up to 30 days were calculated.|Up to Day 30|The intention to treat analysis set (ITT) included all participants who were randomized into the study.|||Days||Standard Deviation|Mean
2566109|NCT02584504|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 20, 24, 36, 48 and 64 -OLTP Analysis||Baseline, Weeks 20, 24, 36, 48 and 64|Open-label treatment (OLT) population included all randomized participants who received at least one dose or part of dose of open-label investigational medicinal product. Here, “number analyzed” signifies participants with available data at each specified time-point.|||Percent change||Standard Deviation|Mean
2566110|NCT02584504|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 12: ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment.|From Baseline to Week 12|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).|||percent change||Standard Error|Least Squares Mean
2566111|NCT02584504|Secondary|Percent Change From Baseline in Fasting Triglycerides (TGs) at Week 12: ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment.|From Baseline to Week 12|ITT population.|||percent change||Standard Error|Mean
2566246|NCT02582814|Primary|Overall Adverse Event Summary|To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.|From baseline to 52 weeks||||Participants|||Count of Participants
2566112|NCT02584504|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12- ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment.|From Baseline to Week 12|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2566113|NCT02584504|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12: ITT Analysis|Adjusted means and standard errors at Week 12 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment were included in the imputation model.|From Baseline to Week 12|ITT population.|||percent change||Standard Error|Mean
2566114|NCT02584504|Secondary|Percentage of Participants Reaching Calculated LDL-C Goal at Week 12- On-Treatment Analysis|Calculated LDL-C goal was defined as calculated LDL-C <100 mg/dL (2.59 mmol/L) for heFH participants or non-FH participants who had a history of documented CHD, or <120 mg/dL (3.10 mmol/L) for non-FH participants who had a history of documented diseases or other risk factors as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. Adjusted percentages at Week 12 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).|Up to Week 12|mITT population.|||percentage of participants|||Number
2566115|NCT02584504|Secondary|Percentage of Participants Reaching Calculated LDL-C Goal at Week 12- ITT Analysis|Calculated LDL-C goal was defined as calculated LDL-C <100 mg/dL (2.59 mmol/L) for heterozygous familiar hypercholesterolemia (heFH) participants or non-familial hypercholesterolemia (non-FH) participants who had a history of documented CHD, or <120 mg/dL (3.10 mmol/L) for non-FH participants who had a history of documented diseases or other risk factors as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012. Adjusted percentages at Week 12 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 12|ITT population.|||percentage of participants|||Number
2566116|NCT02584504|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12- ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment.|From Baseline to Week 12|Participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment (Total-C ITT population).|||percent change||Standard Error|Least Squares Mean
2566117|NCT02584504|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12- On-treatment Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).|From Baseline to Week 12|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on- treatment (non-HDL-C mITT population).|||percent change||Standard Error|Least Squares Mean
2566118|NCT02584504|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12: ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment.|From Baseline to Week 12|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2566119|NCT02584504|Secondary|Percent Change From Baseline in Apo-B at Week 12- On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data at from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).|From Baseline to Week 12|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo-B mITT population).|||percent change||Standard Error|Least Squares Mean
2566120|NCT02584504|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 12: ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment.|From Baseline to Week 12|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).|||percent change||Standard Error|Least Squares Mean
2566121|NCT02584504|Secondary|Percent Change From Baseline in Calculated LDL-C to Averaged Week 10 to 12- On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection) and assigning a weight of 0.5 for Week 10 and 12 time points.|From Baseline to Week 12|mITT population.|||percent change||Standard Error|Least Squares Mean
2566122|NCT02584504|Secondary|Percent Change From Baseline in Calculated LDL-C to Averaged Week 10 to 12: ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment and assigning a weight of 0.5 for Week 10 and 12 time points.|From Baseline to Week 12|ITT population.|||percent change||Standard Error|Least Squares Mean
2566123|NCT02584504|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12- On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 12 (i.e. up to 21 days after last double-blind injection).|From Baseline to Week 12|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2566124|NCT02584504|Primary|Percent Change From Baseline in Calculated LDL-C at Week 12- Intent to Treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 12 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 12 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 12|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2566125|NCT02584452|Secondary|Total Postop Opioid Consumption of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block.|Total postop opioid consumption measured by total pain pills on POD 1 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block.|Post Operative Day1||||Participants|||Count of Participants
2566126|NCT02584452|Secondary|Subjective Pain Scores on POD 3 of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block|Subjective pain scores on POD 3 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block using Subjective Numeric Pain Scale score (on an 11 point scale when 0 is no pain and 10 is worst pain).|Post Operative Day 3|Data was unavailable for 1 participant in the Long Acting Single Bolus Adductor Canal Nerve Block group on post operative day 3.|||Participants|||Count of Participants
2566127|NCT02584452|Secondary|Subjective Assessment of Experience With Analgesia|Subjective assessment of experience with analgesia at post operative week 6 using rating of below expectations; met expectations; exceeded expectations|Post Operative Week 6|Data was unavailable for 1 participant in each group.|||Participants|||Count of Participants
2566128|NCT02584452|Secondary|Postoperative Nausea and Vomiting|Postoperative nausea and vomiting score on POD 1 following discharge from PACU|POD 1 following discharge from PACU||||Participants|||Count of Participants
2566129|NCT02584452|Secondary|Evaluation of Ambulation at Post Operative Week 6 Assessing Independently vs Assistance, With or Without Pain||Post Operative Week 6|Data was unavailable for 1 participant in each group.|||Participants|||Count of Participants
2566130|NCT02584452|Secondary|Subjective Postoperative Pain Score at Post Operative Week 6 of Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block|Subjective postoperative pain score at post operative week 6 of preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to preoperative femoral nerve block plus postoperative saphenous nerve block using Subjective Numeric Pain Scale score with and without activity (on an 11 point scale when 0 is no pain and 10 is worst pain).|Post Operative Week 6|Data was unavailable for 1 participant in each group.|||Participants|||Count of Participants
2566131|NCT02584452|Secondary|Physical Therapy Participation With a Subjective Assessment of Participant Ability to Participate in PT (Full, Partial, None)||Post Operative Day 1|Data was unavailable for 1 participant in both groups.|||Participants|||Count of Participants
2566132|NCT02584452|Secondary|Quadriceps Strength on POD Week 6- Pts Receiving (1) Long-acting Single Bolus Adductor Canal Nerve Block Comparied to (2) Continuous Adductor Canal Nerve Catheter.|Quadriceps strength on POD week 6- pts receiving (1) long-acting single bolus adductor canal nerve block comparied to (2) continuous adductor canal nerve catheter using Straight Leg Raise Tests, 0-5/5 scale, and knee extension, 0-5/5 scale. On both scales (straight leg raise test and knee extension) 0 indicates the minimum value (low muscle contraction/no movement) and 5 indicates the maximum (normal muscle contraction /pt holds position against pressure).|Post Operative Week 6|Data was unavailable for 1 participant in each group.|||Participants|||Count of Participants
2566133|NCT02584452|Secondary|Total Postop Opioid Consumption of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block.|Total postop opioid consumption measured by total pain pills on POD 2 and 3 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block.|Post Operative Day 2 and 3|Data was unavailable for 1 participant in the Long Acting Single Bolus Adductor Canal Nerve Block group on post operative days 2 and 3.|||Participants|||Count of Participants
2566134|NCT02584452|Secondary|Subjective Pain Scores on POD 1 of Patients Receiving (1) Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to (2) Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block|Subjective pain scores on POD 1 of patients receiving (1) preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to (2) preoperative femoral nerve block plus postoperative saphenous nerve block using Subjective Numeric Pain Scale score (on an 11 point scale when 0 is no pain and 10 is worst pain).|Post Operative Day 1||||Participants|||Count of Participants
2566135|NCT02584452|Primary|Quadriceps Strength of on POD 1 of Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postoperative Saphenous Nerve Block at 48 Hours After Discharge From PACU|Quadriceps strength on POD 1 of preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to preoperative femoral nerve block plus postoperative saphenous nerve block using Straight Leg Raise Tests, 0-5/5 scale, and knee extension, 0-5/5 scale. On both scales (straight leg raise test and knee extension) 0 indicates the minimum value (low muscle contraction/no movement) and 5 indicates the maximum (normal muscle contraction /pt holds position against pressure).|Post Operative Day 1|Data was unavailable for 1 participant in both groups.|||Participants|||Count of Participants
2566136|NCT02584452|Primary|Subjective Postoperative Pain Scores After Preoperative Femoral Nerve Block Plus Postoperative Continuous Adductor Canal Nerve Catheter Compared to Preoperative Femoral Nerve Block Plus Postop Saphenous Nerve Block at 48 Hours After Discharge From PACU.|Subjective subjective postoperative pain scores at POD 2 of preoperative femoral nerve block plus postoperative continuous adductor canal nerve catheter compared to preoperative femoral nerve block plus postoperative saphenous nerve block at 48 hours after discharge from PACU using Subjective Numeric Pain Scale score (on an 11 point scale when 0 is no pain and 10 is worst pain).|Post Operative Day 2|Data was unavailable for 1 participant in the Long Acting Single Bolus Adductor Canal Nerve Block group.|||Participants|||Count of Participants
2566265|NCT02582684|Secondary|CD4+ Cell Count|CD4+ cell counts by study week.|Baseline, weeks 4, 12, 24, and 48|All eligible participants enrolled with CD4 count results available at a given visit.|||cells/mm^3||Inter-Quartile Range|Median
2566137|NCT02583477|Secondary|Mean Plasma Concentrations of AZD5069 in Cohort 2|Mean peak and trough plasma concentration of AZD5069 are presented. Concentration of AZD5069 was calculated by plasma concentration-time profile.|Predose (within 60 minutes prior to treatment with any IP) on Day 1 of Cycles 1, 2, 3, 4, and 7; and postdose (within 10 minutes after end of MEDI4736 infusion) on Day 1 of Cycles 1, 2, and 7|The PK analysis set included all participants who received at least 1 dose of IP per protocol for whom any post-dose data were available and who did not violate or deviate from the protocol in ways that would significantly affect the PK analyses.|||nanomoles per liter||Standard Deviation|Mean
2566138|NCT02583477|Secondary|Mean Plasma Concentrations of MEDI4736 in Cohort 2|Mean peak and trough plasma concentrations of MEDI4736 are presented.|Predose (within 60 minutes prior to treatment with any IP) on Day 1 of Cycles 1, 2, 3, 4, and 7; and post infusion (within 10 minutes after end of MEDI4736 infusion) on Day 1 of Cycles 1 and 7|The Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of IP per protocol for whom any post-dose data were available and who did not violate or deviate from the protocol in ways that would significantly affect the PK analyses.|||nanograms per milliliter||Standard Deviation|Mean
2566139|NCT02583477|Secondary|Number of Participants With Anti-Drug Antibody (ADAs) for MEDI4736 in Cohort 2|Samples were measured for the presence of ADAs and ADA-neutralizing antibodies for MEDI4736 using validated assays. Persistently positive is defined as positive at >=2 post-baseline assessments or positive at the last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. NAB = neutralizing antibody.|On Day 1 of Cycles 1, 2, 3, 4, and 7; At months 3 and 6 after last dose|The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.|||Participants|||Count of Participants
2566140|NCT02583477|Secondary|Overall Survival at 12 Months (OS12) in Cohort 2|OS12 is defined as percentage of participants alive at 12 months from first dose of study treatment. OS12 was calculated using the Kaplan-Meier estimate of OS at 12 months.|From first dose of study treatment (Day 1) up to 12 months|The efficacy analysis set included all participants who received at least 1 dose of IP and with no important protocol deviation that could impact the efficacy evaluation.|||percentage of participants||80% Confidence Interval|Number
2566141|NCT02583477|Secondary|Overall Survival at 6 Months (OS6) in Cohort 2|OS6 is defined as percentage of participants alive at 6 months from first dose of study treatment. OS6 was calculated using the Kaplan-Meier estimate of OS at 6 months.|From first dose of study treatment (Day 1) up to 6 months|The efficacy analysis set included all participants who received at least 1 dose of IP and with no important protocol deviation that could impact the efficacy evaluation.|||percentage of participants||80% Confidence Interval|Number
2566142|NCT02583477|Secondary|Median Overall Survival (OS) in Cohort 2|OS is defined as the time from the date of first dose until death due to any cause (i.e. date of death or censoring - date of first dose + 1). OS was calculated using the Kaplan-Meier technique. Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive (censored at end of study).|RECIST assessments performed at baseline (within 28 days before start of study treatment), every 6 weeks +/-7 days for first 48 weeks, then every 12 weeks +/-7 days thereafter until confirmed objective disease progression. Up to approximately 30 months.|The efficacy analysis set included all participants who received at least 1 dose of IP and with no important protocol deviation that could impact the efficacy evaluation.|||months||95% Confidence Interval|Median
2566143|NCT02583477|Secondary|Progression-Free Survival Rate at 6 Months (PFS6) in Cohort 2|The PFS6 was defined as percentage of participants alive and progression-free after 6 months. The PFS6 was calculated using Kaplan-Meier estimates. Tumor progression was determined based on Investigator assessment and RECIST v1.1.|RECIST assessments were performed at baseline (within 28 days before start of study treatment) and every 6 weeks +/- 7 days up to 6 months|The efficacy analysis set included all participants who received at least 1 dose of IP and with no important protocol deviation that could impact the efficacy evaluation.|||percentage of participants||80% Confidence Interval|Number
2566144|NCT02583477|Secondary|Progression-Free Survival Rate at 3 Months (PFS3) in Cohort 2|The PFS rate was defined as percentage of participants alive and progression-free after 3 months. The PFS3 was calculated using Kaplan-Meier estimates. Tumor progression was determined based on Investigator assessment and RECIST v1.1.|RECIST assessments were performed at baseline (within 28 days before start of study treatment) and every 6 weeks +/- 7 days up to 3 months|The efficacy analysis set included all participants who received at least 1 dose of IP and with no important protocol deviation that could impact the efficacy evaluation.|||percentage of participants||80% Confidence Interval|Number
2566145|NCT02583477|Secondary|Median Progression-Free Survival (PFS) in Cohort 2|PFS is defined as the time from the date of first dose until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraws from allocated therapy or receives another anticancer therapy prior to progression. PFS was determined using Investigator assessments according to RECIST v1.1 and calculated using the Kaplan-Meier technique.|RECIST assessments performed at baseline (within 28 days before start of study treatment), every 6 weeks +/-7 days for first 48 weeks, then every 12 weeks +/-7 days thereafter until confirmed objective disease progression. Up to approximately 30 months.|The efficacy analysis set included all participants who received at least 1 dose of IP and with no important protocol deviation that could impact the efficacy evaluation.|||months||95% Confidence Interval|Median
2566153|NCT02583269|Secondary|Change in Systemic Cytokine Levels (Log VEGF)|A mixed model ANOVA model will fit with the outcome of interest (cytokine or growth factor) as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8.|Baseline to up to 8 weeks|Arms were combined for cytokine and phenolic analyses as pre-specified per protocol|||log pg/mL||Standard Error|Least Squares Mean
2566154|NCT02583269|Secondary|Change in Systemic Cytokine Levels (Log IL-8)|A mixed model ANOVA model will fit with the outcome of interest (cytokine or growth factor) as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8.|Baseline to up to 8 weeks|Arms were combined for cytokine and phenolic analyses as pre-specified per protocol|||log pg/mL||Standard Error|Least Squares Mean
2566146|NCT02583477|Secondary|Disease Control Rate (DCR) in Cohort 2|DCR at 6 months is defined as the percentage of participants who had a best objective response (BoR) of CR or PR in the first 6 months (i.e. 24+1=25 weeks to allow for a late assessment within the assessment window) or who had demonstrated stable disease (SD) for a minimum interval of 24 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 161 days) following the start of treatment. DCR at 12 months is defined as the percentage of participants who had a BoR of CR or PR in the first 12 months (i.e. 48+1=49 weeks to allow for a late assessment within the assessment window) or who had demonstrated SD for a minimum interval of 48 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 329 days) following the start of treatment. DCR was determined using Investigator assessments according to RECIST v1.1.|RECIST assessments were performed at baseline (within 28 days before start of study treatment) and every 6 weeks +/- 7 days for first 48 weeks up to 6 months and 12 months|The efficacy analysis set included all participants who received at least 1 dose of IP and with no important protocol deviation that could impact the efficacy evaluation.|||percentage of participants|||Number
2566147|NCT02583477|Secondary|Duration of Response (DoR) in Cohort 2|DoR was defined as the time from the first documentation of CR/PR (which is subsequently confirmed) until the date of progression/death, or the last evaluable RECIST assessment for participants that did not progress or did progress after 2 missed visits of the last evaluable assessment (or first dose). PD was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. DoR was determined using Investigator assessments according to RECIST v1.1 and was calculated using the Kaplan-Meier technique.|RECIST assessments performed at baseline (within 28 days before start of study treatment), every 6 weeks +/-7 days for first 48 weeks, then every 12 weeks +/-7 days thereafter until confirmed objective disease progression. Up to approximately 30 months.|The efficacy analysis set included all participants who received at least 1 dose of IP and with no important protocol deviation that could impact the efficacy evaluation. Participants with confirmed response were evaluated, only one participant showed response.|||weeks||Inter-Quartile Range|Median
2566148|NCT02583477|Primary|Objective Response Rate (ORR) in Cohort 2|ORR is defined as the percentage of participants with a confirmed overall response of complete response (CR) or partial response (PR). A confirmed response of CR/PR means that a response of CR/PR is recorded at 1 visit and confirmed by repeat imaging, preferably at the next regularly scheduled imaging visit and not less than 4 weeks after the visit when the response was first observed with no evidence of progression between the initial and CR/PR confirmation visit. CR is defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 millimeters (mm). PR is defined as at least a 30% decrease in the sum of diameters of TLs, taking as reference the baseline sum of diameters as long as criteria for PD were not met. ORR was determined using Investigator assessments according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).|RECIST assessments performed at baseline (within 28 days before start of study treatment), every 6 weeks +/-7 days for first 48 weeks, then every 12 weeks +/-7 days thereafter until confirmed objective disease progression. Up to approximately 30 months.|The efficacy analysis set included all participants who received at least 1 dose of IP and with no important protocol deviation that could impact the efficacy evaluation.|||percentage of participants||80% Confidence Interval|Number
2566149|NCT02583477|Primary|Number of Participants With AEs|An AE is the development of an undesirable medical condition or deterioration of a pre-existing medical condition following or during exposure to study treatment, whether or not considered causally related to study treatment. An undesirable medical condition can be symptoms, signs or abnormal results of an investigation. A serious AE (SAE) is an AE that fulfills one or more following criteria: death, life-threatening, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity or substantial disruption of ability to conduct normal life functions, congenital abnormality or birth defect, and an important medical event that may jeopardize participant or may require medical intervention to prevent one of outcomes listed above. AEs leading to discontinuation of study treatment were those with action taken was 'Drug Permanently Discontinued' for any study treatment. Only treatment emergent AEs were presented.|From first dose of study treatment administration (Day 1) until 90 days after the last dose of IP or initiation of the first subsequent anticancer therapy (whichever occurred first), approximately 30 months.|The safety analysis set included all participants who received at least 1 dose of IP and for whom any post-dose data were available.|||Participants|||Count of Participants
2566150|NCT02583477|Primary|Number of Participants With Dose-Limiting Toxicities (DLT)|"DLT period was defined as first treatment cycle for Cohort 1, and first dose of AZD5069 and MEDI4736 to end of Cycle 1 or until a participant experienced a DLT, whichever occurs first for Cohort 2.~A DLT was defined as any of below listed laboratory abnormalities or adverse events (AE) related to MEDI4736 collected during DLT period.~Liver transaminase elevation >= 5× but <= 8× upper limit of normal (ULN) that doesn't resolve to Grade 2 within 5 days~Transaminase elevation > 8× ULN or total bilirubin > 5× ULN~Any Grade 4 immune-related AE (irAE) not attributed to local tumor response, Grade >=3 colitis, Grade >=2 pneumonitis that doesn't resolve to <= Grade 1 within 7 days, Grade 3 irAE, that doesn't resolve to Grade <=1 or baseline status within 14 days~Any Grade >=3 non-irAE toxicity that doesn't resolve to Grade <=1 or baseline status within 14 days A DLT was defined as any Grade 3 or worse AE related to AZD5069 that occurs from first dose of AZD5069 up to end of DLT period."|Cohort 1: From time of first dose of MEDI4736 on Day 1 up to Day 28 of Cycle 1 and Cohort 2: From time of first dose of AZD5069 and MEDI4736 on Day 1 up to Day 28 of Cycle 1 or until a participant experiences a DLT, whichever occurs first.|"For Cohort 1: Participants who completed DLT evaluation period and/or discontinued study treatment early due to a DLT and who have not missed >=2 infusions of gemcitabine.~For Cohort 2: Participants who received 50% of planned doses of AZD5069 during DLT period as well as MEDI4736 infusion and remained active on study at end of Day 28 of Cycle 1."|||Participants|||Count of Participants
2566151|NCT02583425|Secondary|The Number of Acute Headache Medication Doses in the Baseline Period (28 Days of Subjects Using Their Usual Medication for Headaches) and in the Treatment Period (28 Days of Subjects Using DFN-11 for Headaches)||28 days Baseline period and 28 days of Treatment period (Total 56 days)||||Number of doses of acute medication used||Standard Deviation|Mean
2566155|NCT02583269|Secondary|Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by PROMIS-Fatigue SF|A mixed model ANOVA model will be fit with phenolic level as the outcome and time (baseline, every 4 weeks) as a fixed effect and subject as a random effect. Contrasts will be use to estimate changes from baseline to each follow-up time period.|Baseline to up to 1 year|||||||
2566156|NCT02583269|Secondary|Change in Component Phenolic Levels in Blood|A mixed model analysis of variance (ANOVA) model will be fit with phenolic level as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8.|Baseline to up to 8 weeks|Outcome measure was not measured||||||
2566157|NCT02583269|Secondary|Change in Component Phenolic Levels in Urine|A mixed model analysis of variance (ANOVA) model will be fit with phenolic level as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8.|Baseline to up to 8 weeks||||ug/ml||Standard Error|Mean
2566158|NCT02583269|Secondary|Progression-free Survival (PFS)|PFS will summarized using the Kaplan-Meier method.|Up to 4 years|||||||
2566159|NCT02583269|Secondary|Overall Survival (OS)|OS will summarized using the Kaplan-Meier method. Median survival rates and associated 95% confidence intervals will be calculated.|Up to 4 years|||||||
2566160|NCT02583269|Secondary|Overall Response Rate of MGE (Complete Response, Partial Response, and Stable Disease)|Response will be characterized using a frequency table.|At 8 weeks|As pre-specified in the protocol, data will be collected and analyzed for all arms combined. At 8 weeks, only 16 patients were evaluable.|||Participants|||Count of Participants
2566161|NCT02583269|Secondary|Incidence of Adverse Events (AEs), Assessed Using NCI CTCAE Version 4.0|AEs/toxicity will be assessed at weeks 4, 8 and every 4 weeks thereafter if patients remain on treatment. Any expected toxicities, any laboratory based toxicities, and any grade 3 or higher gastrointestinal toxicities, and any grade 4 or higher toxicities will be summarized using frequency tables overall and by week.|Up to 1 year||||Participants|||Count of Participants
2566162|NCT02583269|Secondary|Change in Systemic Cytokine Levels|A mixed model ANOVA model will fit with the outcome of interest (cytokine or growth factor) as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8.|Baseline to up to 8 weeks|Arms were combined for cytokine and phenolic analyses as pre-specified per protocol|||pg/mL||Standard Error|Least Squares Mean
2566163|NCT02583269|Secondary|Change in Quality of Life and Fatigue in Cancer Patients Taking MGE as Measured by FACT-G|A mixed model ANOVA model will be fit with phenolic level as the outcome and time (baseline, every 4 weeks) as a fixed effect and subject as a random effect. Contrasts will be use to estimate changes from baseline to each follow-up time period.|Baseline to up to 1 year|||||||
2566164|NCT02583269|Secondary|Change in Total Phenolic Levels in Urine|A mixed model analysis of variance (ANOVA) model will be fit with phenolic level as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8.|Baseline to up to 8 weeks|Arms were combined for cytokine and phenolic analyses as pre-specified per protocol|||ug/ml||Standard Error|Mean
2566165|NCT02583269|Secondary|Change in Total Phenolic Levels in Blood|A mixed model analysis of variance (ANOVA) model will be fit with phenolic level as the outcome and time (baseline, 4, and 8 weeks) as a fixed effect and subject as a random effect. Contrasts will be used to estimate the changes from baseline to week 4 and week 8.|Baseline to up to 8 weeks|Arms were combined for cytokine and phenolic analyses as pre-specified per protocol|||ug/ml||Standard Error|Mean
2566166|NCT02583269|Secondary|Best Response|Best response will be characterized using a frequency table.|At the end of treatment, up to 1 year|||||||
2566167|NCT02583269|Secondary|Adherence to MGE Treatment, as Measured by Percent of Pills Taken at the End of Every 4 Week Period|Pill count will be calculated from counting the number of pills returned as well as by summarizing the patient's pill diary. The percent of pills taken will be summarized by dose level using the mean and 95% confidence interval.|Up to 1 year|||||||
2566168|NCT02583269|Primary|Number of Participants With Dose-Limiting Toxicity|Maximum tolerable dose of muscadine grape extract is defined as the dose level immediately below the dose level that induced a dose-limiting toxicity (DLT) in >= 2 patients, as assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0DLT will be assessed by severity of adverse events.|29 days|As pre-specified in the protocol, data collection and analysis for all arms will be combined. MTD was not determined, as there was not a dose level with ≥2 dose limiting toxicities (DLT). One DLT at dose level 2 and therefore 3 additional participants were enrolled. No subsequent DLTs and the study was stopped at dose level 5, per protocol.|||Participants|||Count of Participants
2566169|NCT02583256|Secondary|Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains|"The percentage of subjects achieving anti-NA titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 after vaccination is reported against homologous strains~Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013."|Day 22, Day 181|The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.|||percentage of subjects||95% Confidence Interval|Number
2566170|NCT02583256|Secondary|Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains|"The percentage of subjects achieving MN titer ≥1:20, ≥1:40, ≥1:80 ≥1:160, ≥1:320 and ≥1:640 at Day 22 and Day 181 after vaccination is reported against homologous strains.~Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013."|Day 22, Day 181|The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data (MN titer ≥1:20, ≥1:40, ≥1:80, >four-fold rise), and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.|||percentage of subjects||95% Confidence Interval|Number
2566171|NCT02583256|Secondary|Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness|Safety of revaccination was assessed in terms of percentage of subjects reporting otitis media, or pneumonia, or influenza-like illness up to 12 months after last vaccination.|Day 1 to Day 366|The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred).|||percentage of subjects|||Number
2566172|NCT02583256|Secondary|Safety Endpoint: Percentage of Subjects With Diagnosis of Failure to Thrive or Short Stature|Safety of revaccination was assessed in terms of percentage of subjects reporting diagnosis of failure to thrive or short stature up to 12 months after last vaccination.|Day 1 to Day 366|The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred).|||percentage of subjects|||Number
2566173|NCT02583256|Secondary|Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE.|"Safety of revaccination was assessed in terms of percentage of subjects reporting SAEs, AEs leading to withdrawal, NOCD, AESI and medically attended AE. Each subject was followed for a period of 12 months after receipt of the study vaccine.~NOCDs include AEs that represents a new diagnosis of a chronic medical condition that was not present or suspected in a subject prior to study enrollment. AESIs include potentially immune-mediated disorders which were reported by the investigators."|Day 1 to Day 366|The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited adverse event (AE) data (including those where it was reported/confirmed that no events had occurred).|||percentage of subjects|||Number
2566174|NCT02583256|Secondary|Safety Endpoint: Percentage of Subjects With Unsolicited AEs|Safety of revaccination was assessed in terms of percentage of subjects reporting unsolicited AEs during the overall study period (Day 1 to Day 366).|Day 1 to Day 366|The unsolicited safety set consisting of all subjects who received a study vaccination with documented safety assessments for unsolicited AE data (including those where it was reported/confirmed that no events had occurred).|||percentage of subjects|||Number
2566175|NCT02583256|Secondary|Safety Endpoint: Percentage of Subjects With Solicited AEs|Safety of revaccination was assessed in terms of percentage of subjects reporting solicited AEs up to 7 days after vaccination.|Day 1 to Day 7 after vaccination|The solicited safety set consisting of all subjects who received a study vaccination with evaluable solicited AE data recorded on a diary card.|||percentage of subjects|||Number
2566176|NCT02583256|Secondary|Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains|"The GMR is the geometric mean of the fold increase in anti-NA titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed against homologous strains using ANCOVA with study specific covariates.~Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013."|Day 22/Day 1 and Day 181/Day 1|The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.|||ratio||95% Confidence Interval|Geometric Mean
2566177|NCT02583256|Secondary|Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains|"To further characterize immune response, adjusted anti-NA GMT and 95% CI were analyzed for Day 1, Day 22, and Day 181 against homologous strains.~Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013."|Day 1, Day 22, Day 181|The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.|||titer||95% Confidence Interval|Geometric Mean
2566178|NCT02583256|Secondary|Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains|"The GMR is the geometric mean of the fold increase in MN titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed for the homologous strains using ANCOVA with study specific covariates.~Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013."|Day 22/Day 1 and Day 181/Day 1|The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.|||ratio||95% Confidence Interval|Geometric Mean
2566179|NCT02583256|Secondary|Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains|"To further characterize immune response, MN GMT and 95% CI were analyzed for Day 1, Day 22, and Day 181 against homologous strains.~Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013."|Day 1, Day 22, Day 181|The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.|||titer||95% Confidence Interval|Geometric Mean
2566180|NCT02583256|Secondary|Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains|"The percentage of subjects achieving HI titer ≥1:40 at Day 22 and Day 181 after vaccination and the percentage of subject who experienced seroconversion is reported for homologous strains. Seroconversion was defined in subjects seronegative at baseline (i.e. HI titer <1:10 on Day 1) as post-vaccination HI titer ≥1:40 and defined in subjects seropositive at baseline (i.e. HI titer ≥1:10 on Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.~The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B/Victoria lineage strain, B/Malaysia/2506/2004."|Day 22, Day 181|The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.|||percentage of subjects||95% Confidence Interval|Number
2566181|NCT02583256|Secondary|Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains|"The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed for the heterologous strains using ANCOVA with study specific covariates.~The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B Victoria lineage strain, B/Malaysia/2506/2004."|Day 22/Day 1 and Day 181/Day 1|The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.|||ratio||95% Confidence Interval|Geometric Mean
2566182|NCT02583256|Secondary|Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains|"GMT and 95% CI were analyzed for Day 22 for the heterologous strains using ANCOVA with study specific covariates.~The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B/ Victoria lineage strain, B/Malaysia/2506/2004."|Day 1, Day 22, Day 181|The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.|||titer||95% Confidence Interval|Geometric Mean
2566183|NCT02583256|Secondary|Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains|"The percentage of subjects achieving HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 at Day 22 after vaccination is reported against homologous strains.~Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013."|Day 22|The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.|||percentage of subjects||95% Confidence Interval|Number
2566184|NCT02583256|Secondary|Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains|"The percentage of subjects achieving HI titer ≥1:40 at Day 22 and Day 181 after vaccination is reported against homologous strains.~Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013."|Day 22, Day 181|The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.|||percentage of subjects||95% Confidence Interval|Number
2566185|NCT02583256|Secondary|Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains|"The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed against homologous strains using ANCOVA with study specific covariates.~Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013."|Day 22, Day 181|The immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.|||ratio||95% Confidence Interval|Geometric Mean
2566186|NCT02583256|Secondary|Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)|"The percentage of subjects achieving seroconversion at Day 22 after vaccination is reported against homologous strains. Seroconversion was defined in subjects seronegative at baseline (i.e. HI titer <1:10 on Day 1) as postvaccination HI titer ≥1:40 and defined in subjects seropositive at baseline (i.e. HI titer ≥1:10 on Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.~Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013."|Day 1, Day 22|The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.|||percentage of subjects||95% Confidence Interval|Number
2566187|NCT02583256|Secondary|Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)|"GMT and 95% CI were analyzed for Day 181 against homologous strains using ANCOVA with study specific covariates.~Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013."|Day 181|The Immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.|||titer||95% Confidence Interval|Geometric Mean
2566188|NCT02583256|Secondary|Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison)|"GMT and 95% CI were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.~Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013."|Day 22|The immunogenicity PPS consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop RT-PCR-confirmed influenza infection between baseline and Visit 2.|||titer||95% Confidence Interval|Geometric Mean
2566189|NCT02583256|Primary|Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis|"GMT and 95% CI were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.~Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013."|Day 22|The immunogenicity full analysis set (FAS) consisting of all subjects who received a study vaccination and provided immunogenicity data at both Visit 1 (baseline) and at least one post-vaccination visit.|||titer||95% Confidence Interval|Geometric Mean
2566244|NCT02582814|Primary|Diabetic Ketoacidosis (DKA)|To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.|From baseline to 52 weeks||||Participants|||Count of Participants
2566190|NCT02583256|Primary|Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis|"GMT and 95% confidence interval (CI) were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.~Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013."|Day 22|Immunogenicity per protocol set (PPS) consisting of all subjects who received a study vaccination and provided immunogenicity data, and who correctly received the study vaccine, had no major protocol deviations, and did not develop reverse transcription polymerase chain reaction(RT-PCR) confirmed influenza infection between baseline and Visit 2.|||titer||95% Confidence Interval|Geometric Mean
2566191|NCT02583230|Secondary|Quick Inventory of Depressive Symptomatology Clinician Rating (QIDS-C)|This measure assesses depressive symptom severity. The total score is obtained by adding the scores for each of the nine symptom domains of the DSM-IV MDD (major depressive disorder) criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes (Rush et al. 2003). Sixteen items are used to rate the nine criterion symptom domains of a major depressive episode. Each item is rated 0-3. For symptom domains that require more than one item, the highest score of the item relevant for each domain is taken. The total score ranges from 0-27. Higher values represent a worse outcome. Specifically, scores of 0-5 indicate no depression; 6-10 is mild; 11-15 is moderate; 16-20 is severe; and 21-27 is very severe.|Baseline, Week 4, and Week 8||||units on a scale||Standard Deviation|Mean
2566192|NCT02583230|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The PHQ-9 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-27. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-27 is severe.|Baseline, Week 4, and Week 8||||units on a scale||Standard Deviation|Mean
2566193|NCT02583230|Primary|Adherence to Antidepressant Medication|Number of days medication was taken when a dose was expected. Measured through % of days adherent on Wisepill pillbox as well as 2. Self-reported adherence: Patient Adherence Questionnaire (PAQ).|8 weeks||||% of days adherent|||Number
2566194|NCT02583048|Secondary|Percentage of Participants Who Died|Among participants who took at least one dose of study TB treatment, percentage of participants who died on or before week 24. Note that the all-cause mortality includes deaths that occurred at any time during treatment or follow-up through week 128.|From initiation of study TB treatment (week 0) to week 24|Participants who took at least one dose of study TB treatment.|||Percentage of participants||95% Confidence Interval|Number
2566195|NCT02583048|Secondary|Percentage of Participants Who Discontinued Study TB Drug(s) For Any Reason|Percentage of participants who discontinued study TB drug(s) for any reason|From initiation of study TB treatment (week 0) to week 24|Participants who took at least one dose of study TB treatment.|||Percentage of participants||95% Confidence Interval|Number
2566196|NCT02583048|Secondary|Percentage of Participants With an Occurrence of Grade 3 or Higher Adverse Event|Participants with an occurrence of an adverse event (laboratory value, sign/symptom, diagnosis) of grade 3 or 4. Severity grading based on DAIDS AE Grading Table Version 2.0. Participants were counted once at the highest grade (grade 3 or grade 4).|From initiation of study TB treatment (week 0) to week 24|Participants who took at least one dose of study TB treatment.|||Percentage of participants||95% Confidence Interval|Number
2566197|NCT02583048|Secondary|Means of PK Parameters for Delamanid and Its DM-6705 Metabolite|PK parameters consist of Cmin, Cmax and AUC. Estimated using noncompartmental methods applied to concentrations from intensive PK sampling, and visit-specific geometric mean ratios (Arm 3 relative to Arm 2). Concentrations dataset not yet provided to pharmacologist, therefore analysis results are delayed.|Weeks 2, 8 and 24||2020-12-31|12/2020||||
2566198|NCT02583048|Secondary|Means of PK Parameters for Bedaquiline and Its M2 Metabolite|PK parameters consist of Cmin, Cmax and AUC. Estimated using noncompartmental methods applied to concentrations from intensive PK sampling, and visit-specific geometric mean ratios (Arm 3 relative to Arm 1). Concentrations dataset not yet provided to pharmacologist, therefore analysis results are delayed.|At weeks 2, 8 and 24||2020-12-31|12/2020||||
2566199|NCT02583048|Secondary|Percentage of Participants With an Occurrence of QTcF Increase From Baseline of >30 and ≤60 Milliseconds (ms)|Participants who experienced QTcF increase from baseline of >30 and ≤60 ms at least once at any time from week 2 to 24. QTcF calculated as average of 1-3 available QTcF values per visit.|Baseline and at weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24|Participants who took at least one dose of study treatment.|||Percentage of participants||95% Confidence Interval|Number
2566200|NCT02583048|Secondary|Percentage of Participants With an Occurrence of QTcF >480 and ≤500 Milliseconds (ms)|Participants who experienced QTcF >480 and ≤500 ms at least once at any time from week 2 to 24. QTcF calculated as average of 1-3 available QTcF values per visit.|At weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24|Participants who took at least one dose of study TB drug(s).|||Percentage of participants||95% Confidence Interval|Number
2566201|NCT02583048|Secondary|Changes in QTcF From Baseline|Change from baseline in QTcF, calculated as the difference between each post-baseline week and week 0. (QTcF calculated as average of 1-3 available QTcF values per visit.)|Baseline and at weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 and 28.|Participants with baseline and at least one post baseline QTcF collected at a scheduled visit while taking study TB drug(s).|||milliseconds (ms)||Full Range|Median
2566202|NCT02583048|Secondary|Percentage of Participants With an Increase in QTcF From Baseline of Greater Than 60 Milliseconds (ms)|Participants who experienced QTcF increase from baseline greater than 60 ms at least once at any time from week 2 to 24. QTcF calculated as average of 1-3 available QTcF values per visit.|Baseline and at weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24|Participants who took at least one dose of study TB treatment.|||Percentage of participants||95% Confidence Interval|Number
2566203|NCT02583048|Secondary|Percentage of Participants With an Occurrence of QTcF Greater Than 500 Milliseconds (ms)|Participants who experienced QTcF greater than 500 ms at least once at any time from week 2 to 24. QTcF calculated as average of 1-3 available QTcF values per visit.|At weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24|Participants who took at least one dose of study TB treatment.|||Percentage of participants||95% Confidence Interval|Number
2566204|NCT02583048|Primary|Post-Baseline QTcF|Baseline and post-baseline absolute QTcF in milliseconds (ms) estimated using an ANOVA model, where baseline QTcF was represented by QTcF durations measured at week 0, and post-baseline QTcF was represented by QTcF durations measured at weeks 8 through 24 (pooled). QTcF calculated as average of 1-3 available QTcF values per visit. Interim analysis conducted when week 24 QT data was available for ≥12 participants stipulated 99.9% confidence interval; original coverage of 95% was widened to 95.1%.|Baseline and at weeks 8, 10, 12, 14, 16, 18, 20, 22, and 24.|Participants with a baseline QTcF measurement, and at least one post-baseline QTcF measurement from a visit conducted at week 8 through 24, prior to permanent discontinuation of study Tuberculosis (TB) drug and without a temporary discontinuation of study TB drug of 7 or more days immediately preceding the measurement.|||milliseconds (ms)||95.1% Confidence Interval|Least Squares Mean
2566205|NCT02583048|Primary|Mean Change From Baseline in QTcF|Mean change from baseline in QTcF (ie, QTcF prolongation) in milliseconds (ms), where baseline QTcF was represented by QTcF durations measured at week 0, and post-baseline QTcF was represented by QTcF durations measured at weeks 8 through 24 (pooled). QTcF calculated as average of 1-3 available QTcF values per visit.|Baseline and at weeks 8, 10, 12, 14, 16, 18, 20, 22 and 24|Participants with a baseline QTcF measurement, and at least one post-baseline QTcF measurement from a visit conducted at week 8 through 24, prior to permanent discontinuation of study Tuberculosis (TB) drug and without a temporary discontinuation of study TB drug of 7 or more days immediately preceding the measurement.|||milliseconds (ms)||95.1% Confidence Interval|Mean
2566206|NCT02582983|Primary|Number of Participants With Premature Withdrawal Due to Adverse Events||Up to 96 weeks|The analysis population was defined as the number of participants who enrolled in the study and received at least one dose of study drug.|||participants|||Number
2566207|NCT02582983|Primary|Number of Participants With Serious Adverse Events (SAEs)|"A serious adverse event is any untoward medical occurrence that at any dose: results in death, or is life-threatening, or requires inpatient hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. The term life-threatening in the definition of serious refers to an event in which the patient was at risk of death at the time of the event, not an event which hypothetically might have caused death if it were more severe."|Up to 28 days after permanent discontinuation of study treatment (approximately 100 weeks)|The analysis population was defined as the number of participants who enrolled in the study and received at least one dose of study drug.|||participants|||Number
2566208|NCT02582970|Secondary|Mean Direct Medical Cost for Cancer Related Medical Care Utilization|Direct medical cost included cost of out-patient consultation and cost of hospitalization.|Baseline up to approximately 3 years|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Number Analyzed = participants who were evaluable for specified categories of this outcome measure.|||Thousands in New Taiwan Dollar||Standard Deviation|Mean
2566209|NCT02582970|Secondary|Number of Participants With Best Overall Response|The best overall response was defined as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Progressive disease (PD): at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Complete response (CR): disappearance of all TL and non-TL. If immunocytology was available, no disease was to be detected by that methodology. Partial response (PR): at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Stable disease (SD): neither sufficient shrinkage to qualify for PR or increase to qualify for PD.|Baseline up to approximately 3 years|ITT population.|||participants|||Number
2566210|NCT02582970|Secondary|Progression-Free Survival Time|Progression-free survival was defined as the duration from the date of starting first-line therapy to the date of documented disease progression or death from any cause. Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-TL. Progression-free survival was estimated using Kaplan-Meier analysis.|Baseline up to approximately 3 years|ITT population.|||months||95% Confidence Interval|Median
2566211|NCT02582970|Secondary|Percentage of Participants With Disease Progression or Death|Disease progression was defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions (TL).|Baseline up to approximately 3 years|ITT population.|||percentage of participants|||Number
2566212|NCT02582970|Secondary|Duration of Survival|Duration of survival was defined as the time period from the start of first line therapy to death. Duration of survival was estimated using Kaplan-Meier analysis.|Baseline up to approximately 3 years|ITT population.|||months||95% Confidence Interval|Median
2566213|NCT02582970|Secondary|Percentage of Participants Who Died||Baseline up to approximately 3 years|ITT population.|||percentage of participants|||Number
2566214|NCT02582970|Primary|Percentage of Participants With Adverse Events|An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug.|Baseline up to approximately 3 years|ITT population.|||percentage of participants|||Number
2566215|NCT02582840|Secondary|Seated Systolic Blood Pressure (mmHG) Change From Baseline to Day 7 - Pharmacodynamic (PD) Set||Baseline (the last available assessment on or prior to the first dose of study medication), Day 7|Pharmacodynamic set Part A (PD-A): The PD set consisted of all randomized subjects who received at least one dose of randomized study medication for Part A, and who had a non missing baseline value and at least one post-baseline value for at least one pharmacodynamic variable.|||mmHG||Standard Deviation|Mean
2566216|NCT02582840|Secondary|Fasting Plasma Glucose (FPG) (mg/dL) Change From Baseline to Day 7 - Pharmacodynamic (PD) Set||Baseline (the last available assessment on or prior to the first dose of study medication), Day 7|Pharmacodynamic set Part A (PD-A): The PD set consisted of all randomized subjects who received at least one dose of randomized study medication for Part A, and who had a non missing baseline value and at least one post-baseline value for at least one pharmacodynamic variable.|||mg/dL||Standard Deviation|Mean
2566217|NCT02582840|Secondary|Daily Bolus Insulin (IU) Percent Change From Baseline to Day 7 - Pharmacodynamic (PD) Set|Mean percent change from baseline was calculated using the geometric mean back-transformed from the results calculated under the logarithm transformation.|Baseline (the last available assessment on or prior to the first dose of study medication), Day 7|Pharmacodynamic set Part A (PD-A): The PD set consisted of all randomized subjects who received at least one dose of randomized study medication for Part A, and who had a non missing baseline value and at least one post-baseline value for at least one pharmacodynamic variable.|||percent change||Standard Error|Mean
2566218|NCT02582840|Secondary|Daily Basal Insulin (IU) Percent Change From Baseline to Day 7 - Pharmacodynamic (PD) Set|Mean percent change from baseline was calculated using the geometric mean back-transformed from the results calculated under the logarithm transformation.|Baseline (the last available assessment on or prior to the first dose of study medication), Day 7|Pharmacodynamic set Part A (PD-A): The PD set consisted of all randomized subjects who received at least one dose of randomized study medication for Part A, and who had a non missing baseline value and at least one post-baseline value for at least one pharmacodynamic variable.|||percent change||Standard Error|Mean
2566219|NCT02582840|Secondary|Total Daily Insulin (IU) Percent Change From Baseline to Day 7 - Pharmacodynamic (PD) Set|Total daily insulin dose is defined as the sum of all insulin doses (basal+bolus+premixed) for each day. Mean percent change from baseline was calculated using the geometric mean back-transformed from the results calculated under the logarithm transformation.|Baseline (the last available assessment on or prior to the first dose of study medication), Day 7|Pharmacodynamic set Part A (PD-A): The PD set consisted of all randomized subjects who received at least one dose of randomized study medication for Part A, and who had a non missing baseline value and at least one post-baseline value for at least one pharmacodynamic variable.|||percent chagne||Standard Error|Mean
2566220|NCT02582840|Primary|24-hour Urinary Glucose (g/24h) Mean Change From Baseline on Day 7 - Pharmacodynamic (PD) Set|The 24-hour period is defined based on the morning void, from the first morning void to the one of the next day.|Baseline (the last available assessment prior to the first dose of study medication), Day 7|Pharmacodynamic set Part A (PD-A): The PD set consisted of all randomized subjects who received at least one dose of randomized study medication for Part A, and who had a non missing baseline value and at least one post-baseline value for at least one pharmacodynamic variable.|||g/24-hour||Standard Deviation|Mean
2566221|NCT02582840|Primary|Dapagliflozin Ratio of Metabolite to Parent AUC of 7 Days Repeated Doses of Dapagliflozin - Pharmacokinetic (PK) Set|Serial blood samples for determination of study drug were collected predose Day 1, Day 7 (60 minutes prior to dose), Day 7 (0, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose).|Day 1-7|Pharmacokinetic set – Part A (PK-A): The PK set consisted of all randomized subjects who had at least one dose of randomized study medication for Part A and had an evaluable plasma concentration data of dapagliflozin and/or its major metabolite dapagliflozin 3-O-glucuronide.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2566222|NCT02582840|Primary|Dapagliflozin 3-O-Glucuronide Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-T) of 7 Days Repeated Doses of Dapagliflozin - Pharmacokinetic (PK) Set|Serial blood samples for determination of study drug were collected predose Day 1, Day 7 (60 minutes prior to dose), Day 7 (0, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose).|Day 1-7|Pharmacokinetic set – Part A (PK-A): The PK set consisted of all randomized subjects who had at least one dose of randomized study medication for Part A and had an evaluable plasma concentration data of dapagliflozin and/or its major metabolite dapagliflozin 3-O-glucuronide.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2566223|NCT02582840|Primary|Dapagliflozin 3-O-Glucuronide Time of Maximum Observed Plasma Concentration (Tmax) of 7 Days Repeated Doses of Dapagliflozin - Pharmacokinetic (PK) Set|Serial blood samples for determination of study drug were collected predose Day 1, Day 7 (60 minutes prior to dose), Day 7 (0, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose).|Day 1-7|Pharmacokinetic set – Part A (PK-A): The PK set consisted of all randomized subjects who had at least one dose of randomized study medication for Part A and had an evaluable plasma concentration data of dapagliflozin and/or its major metabolite dapagliflozin 3-O-glucuronide.|||hours||Full Range|Median
2566224|NCT02582840|Primary|Dapagliflozin 3-O-Glucuronide Minimum Observed Plasma Concentration (Cmin) of 7 Days Repeated Doses of Dapagliflozin - Pharmacokinetic (PK) Set|Serial blood samples for determination of study drug were collected predose Day 1, Day 7 (60 minutes prior to dose), Day 7 (0, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose).|Day 1-7|Pharmacokinetic set – Part A (PK-A): The PK set consisted of all randomized subjects who had at least one dose of randomized study medication for Part A and had an evaluable plasma concentration data of dapagliflozin and/or its major metabolite dapagliflozin 3-O-glucuronide.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2566225|NCT02582840|Primary|Dapagliflozin 3-O-Glucuronide Maximum Observed Plasma Concentration (Cmax) of 7 Days Repeated Doses of Dapagliflozin - Pharmacokinetic (PK) Set|Serial blood samples for determination of study drug were collected predose Day 1, Day 7 (60 minutes prior to dose), Day 7 (0, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose).|Day 1-7|Pharmacokinetic set – Part A (PK-A): The PK set consisted of all randomized subjects who had at least one dose of randomized study medication for Part A and had an evaluable plasma concentration data of dapagliflozin and/or its major metabolite dapagliflozin 3-O-glucuronide.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2566226|NCT02582840|Primary|Dapagliflozin Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-T) of 7 Days Repeated Doses of Dapagliflozin - Pharmacokinetic (PK) Set|Serial blood samples for determination of study drug were collected predose Day 1, Day 7 (60 minutes prior to dose), Day 7 (0, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose).|Day 1-7|Pharmacokinetic set – Part A (PK-A): The PK set consisted of all randomized subjects who had at least one dose of randomized study medication for Part A and had an evaluable plasma concentration data of dapagliflozin and/or its major metabolite dapagliflozin 3-O-glucuronide.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2566227|NCT02582840|Primary|Dapagliflozin Time of Maximum Observed Plasma Concentration (Tmax) of 7 Days Repeated Doses of Dapagliflozin - Pharmacokinetic (PK) Set|Serial blood samples for determination of study drug were collected predose Day 1, Day 7 (60 minutes prior to dose), Day 7 (0, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose).|Day 1-7|Pharmacokinetic set – Part A (PK-A): The PK set consisted of all randomized subjects who had at least one dose of randomized study medication for Part A and had an evaluable plasma concentration data of dapagliflozin and/or its major metabolite dapagliflozin 3-O-glucuronide.|||hours||Full Range|Median
2566228|NCT02582840|Primary|Dapagliflozin Minimum Observed Plasma Concentration (Cmin) of 7 Days Repeated Doses of Dapagliflozin - Pharmacokinetic (PK) Set|Serial blood samples for determination of study drug were collected predose Day 1, Day 7 (60 minutes prior to dose), Day 7 (0, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose).|Day 1-7|Pharmacokinetic set – Part A (PK-A): The PK set consisted of all randomized subjects who had at least one dose of randomized study medication for Part A and had an evaluable plasma concentration data of dapagliflozin and/or its major metabolite dapagliflozin 3-O-glucuronide.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2566229|NCT02582840|Primary|Dapagliflozin Maximum Observed Plasma Concentration (Cmax) of 7 Days Repeated Doses of Dapagliflozin - Pharmacokinetic (PK) Set|Serial blood samples for determination of study drug were collected predose Day 1, Day 7 (60 minutes prior to dose), Day 7 (0, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose).|Day 1-7|Pharmacokinetic set – Part A (PK-A): The PK set consisted of all randomized subjects who had at least one dose of randomized study medication for Part A and had an evaluable plasma concentration data of dapagliflozin and/or its major metabolite dapagliflozin 3-O-glucuronide.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2566230|NCT02582814|Primary|Vital Signs (Blood Pressure)|To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.|From baseline to 52 weeks|Subjects with both non-missing baseline and non-missing Week 52 were included.|||mmHg||Standard Deviation|Mean
2566231|NCT02582814|Primary|Clinical Laboratory Measures, Urine Test Results (Any Marked Abnormality)|To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.|From baseline to 52 weeks|Subjects with non-missing post-baseilne measurements were included.|||Participants|||Count of Participants
2566232|NCT02582814|Primary|ECGs|To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.|From baseline to 52 weeks||||Participants|||Count of Participants
2566233|NCT02582814|Primary|Vital Signs (Heart Rate)|To evaluate safety and tolerability of long-term treatment (52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM with inadequate glycemic control under standard insulin therapy.|From baseline to 52 weeks|Subjects with both non-missing baseline and non-missing Week 52 were included.|||bpm||Standard Deviation|Mean
2566234|NCT02582814|Secondary|Adjusted Change From Baseline in SBP in Subjects With Baseline SBP/DBP >= 140/90 mmHg|To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin|From baseline to 24/52 weeks|Subjects with baseline SBP >= 140mmHg and/or baselien DBP >= 90mmHg were included in analysis.|||mmHg||95% Confidence Interval|Least Squares Mean
2566235|NCT02582814|Secondary|Proportion of Subjects Achieving HbA1c < 7.0 Percent|To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin|From baseline to 24/52 weeks|Subjects with non-missing HbA1c baseline and Week24/52 (LOCF) values were included.|||percentage of participants||95% Confidence Interval|Number
2566236|NCT02582814|Secondary|Proportion of Subjects Achieving HbA1c Reduction of 0.5 Percent|To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin|From baseline to 24/52 weeks|Subjects with non-missing HbA1c baseline and Week24/52 (LOCF) values were included.|||percentage of participants||95% Confidence Interval|Number
2566237|NCT02582814|Secondary|Proportion of Subjects Achieving HbA1c Reduction of 0.5 Percent Without Severe Hypoglycemia|To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin|From baseline to 24/52 weeks|Subjects with non-missing HbA1c baseline and Week24/52 (LOCF) values were included.|||percentage of participants||95% Confidence Interval|Number
2566238|NCT02582814|Secondary|Adjusted Change From Baseline in Post-prandial Glucose Measured by 6-point SMBG|To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin therapy.|From baseline to 24/52 weeks|All available post-baseline data were included in analysis. Nubmer of observations at each time point is presented in the table below.|||mg/dL||95% Confidence Interval|Least Squares Mean
2566239|NCT02582814|Secondary|Adjusted Change From Baseline in Average Daily Glucose Measured by 6-point SMBG|To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin therapy.|From baseline to 24/52 weeks|All available post-baseline data were included in analysis. Nubmer of observations at each time point is presented in the table below.|||mg/dL||95% Confidence Interval|Least Squares Mean
2566240|NCT02582814|Secondary|Adjusted Change From Baseline in Glycoalbumin|To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin therapy.|From baseline to 24/52 weeks|All available post-baseline data were included in analysis. Nubmer of observations at each time point is presented in the table below.|||percent||95% Confidence Interval|Least Squares Mean
2566241|NCT02582814|Secondary|Adjusted Percent Change From Baseline in Body Weight|To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin therapy.|From baseline to 24/52 weeks|All available post-baseline data were included in analysis. Nubmer of observations at each time point is presented in the table below.|||percent change||95% Confidence Interval|Least Squares Mean
2566242|NCT02582814|Secondary|Adjusted Percent Change From Baseline in Total Daily Insulin Dose|To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin therapy.|From baseline to 24/52 weeks|All available post-baseline data were included in analysis. Nubmer of observations at each time point is presented in the table below.|||percent change||95% Confidence Interval|Least Squares Mean
2566243|NCT02582814|Secondary|Adjusted Change From Baseline in HbA1c|To assess the efficacy of long-term treatment (24/52 weeks) of dapagliflozin 5mg and 10 mg in Japanese patients with T1DM inadequately controlled on insulin therapy.|From baseline to 24/52 weeks|All available post-baseline data were included in analysis. Nubmer of observations at each time point is presented in the table below.|||percent||95% Confidence Interval|Least Squares Mean
2566247|NCT02582749|Secondary|Analgesic Use by WHO Ladder Score|Analgesic use scores for subjects on both arms will be assigned by the treating physician based on the subject's daily analgesic use on average. A single numeric score (0, 1, 2 or 3) will be assigned based on the 3-step WHO pain ladder.|From baseline until 30 days after the last treatment, assessed for a maximum of 24 months|Data was not collected or analyzed for this objective due to the termination of the study by the funder||||||
2566248|NCT02582749|Secondary|Change in Pain Over Time|Subjects on both arms self-reported evaluation of worst pain item, as well as the subscale scores for pain severity and pain interference as determined by subject responses on the BPI-SF questionnaire.|From baseline until 30 days after the last treatment, assessed for a maximum of 24 months|Data was not collected or analyzed for this objective due to the termination of the study by the funder||||||
2566249|NCT02582749|Secondary|Time to ALP Progression|ALP progression of 25% or greater from baseline/nadir for subjects on both arms|From date of randomization until date of ALP progression, assessed up to 24 months|Data was not collected or analyzed for this objective due to the termination of the study by the funder||||||
2566250|NCT02582749|Secondary|12-Week Alkaline Phosphatase (ALP) Normalization|ALP normalization for subjects with abnormal ALP at randomization|From date of randomization until completion of 12 weeks of therapy|Data was not collected or analyzed for this objective due to the termination of the study by the funder||||||
2566251|NCT02582749|Secondary|2-Year Overall Survival (OS)|OS for subjects on both arms|From date of randomization to death from any cause, assessed up to 24 months|Data was not collected or analyzed for this objective due to the termination of the study by the funder||||||
2566252|NCT02582749|Secondary|2-Year PSA Progression Free Survival (PFS)|PSA PFS for subjects on both arms defined as first PSA level increase|From date of randomization to first occurrence of PSA progression, symptomatic deterioration, or death due to any cause, assessed up to 24 months|Data was not collected or analyzed for this objective due to the termination of the study by the funder||||||
2566253|NCT02582749|Secondary|Median Time to Castration Resistance|Castration resistance for subjects on both arms determined by first PSA level increase and/or radiographic progression by first imaging assessment showing progression|From date of ADT (first LHRH agonist/antagonist/surgical castration) to date of PSA and/or radiographic progression, assessed for a maximum of 24 months|Data was not collected or analyzed for this objective due to the termination of the study by the funder||||||
2566254|NCT02582749|Secondary|PSA Partial Response Rates|Subjects on both arms with PSA between 0.2 and ≤ 4 ng/mL after 7 months of androgen deprivation therapy.|From date of first dose of ADT until completion of 7 cycles (28 weeks)|Data was not collected or analyzed for this objective due to the termination of the study by the funder||||||
2566255|NCT02582749|Secondary|PSA Complete Response Rates|Subjects on both arms with PSA ≤ 0.2 ng/mL after 7 months of androgen deprivation therapy|From date of first dose of androgen deprivation therapy (ADT) until completion of 7 cycles (28 weeks)|Data was not collected or analyzed for this objective due to the termination of the study by the funder||||||
2566256|NCT02582749|Secondary|Secondary Neoplasms|Secondary neoplasms of subjects on both arms assessed by bone scan or axial imaging|From date of first dose until 30 days after the last treatment, assessed for a maximum of 24 months|Data was not collected or analyzed for this objective due to the termination of the study by the funder||||||
2566257|NCT02582749|Secondary|Time to First Skeletal-Related Event (SRE)|SRE of subjects on both arms assessed by bone scan or axial imaging|From date of first dose until 30 days after the last treatment, assessed for a maximum of 24 months|Data was not collected or analyzed for this objective due to the termination of the study by the funder||||||
2566258|NCT02582749|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI Common Terminology Criteria for Adverse Events v 4.0 (CTCAE)|The intensity of AEs for subjects on both arms graded according to CTCAE v4.0 on a five-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening and Death)|From date of first dose until 30 days after the last treatment, assessed for a maximum of 24 months|Data was not collected or analyzed for this objective due to the termination of the study by the funder||||||
2566259|NCT02582749|Primary|Radiological Progression-Free Survival (rPFS)|rPFS assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) to compare outcomes of subjects on experimental arm vs control arm|From date of randomization to disease progression or death from any cause, up to a maximum of 24 months.|Data was not collected or analyzed for this objective due to the termination of the study by the funder||||||
2566260|NCT02582684|Secondary|Number of Participants With Grade 3 of Higher Adverse Events|Number of participants who experienced an AE (sign/symptom or laboratory abnormality) of Grade 3 or higher. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see reference in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening.|from study treatment dispensation through up to week 52 or until study discontinuation|All eligible participants enrolled.|||Participants|||Count of Participants
2566261|NCT02582684|Secondary|Creatinine Clearance|Creatinine clearance was estimated by the Cockcroft-Gault equation.|Baseline, weeks 4, 12, 24, 32, 40 and 48|All eligible participants enrolled with creatinine clearance results available at a given time point.|||mL/min||Inter-Quartile Range|Median
2566262|NCT02582684|Secondary|Fasting Lipids and Glucose|Fasting lipids include: total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, and glucose. Fasting was set to be 8 hours prior to the sample collection.|Baseline and week 48|All eligible participants enrolled with lipids results available at a given time point.|||mg/dL||Inter-Quartile Range|Median
2566263|NCT02582684|Secondary|Number of HIV-1 Drug Resistance Mutation Occurrences in Participants|Number of HIV-1 drug resistance mutation occurrences participants with virologic failure and FDA snapshot non-successes. Participants that had one drug class resistance mutation may have one or more mutations.|at the time of virologic failure|Of the enrolled eligible participants, those with virologic failures had resistance testing done.|||number of mutation occurrences|||Number
2566264|NCT02582684|Secondary|Change in CD4+ Cell Count|Change in CD4+ cell counts by study week. Change was calculated as value at the later visit minus the value at baseline.|Baseline, weeks 4, 12, 24, and 48|All eligible participants enrolled with CD4 cell count results available at baseline and the given visit.|||cells/mm^3||Inter-Quartile Range|Median
2566266|NCT02582684|Secondary|Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- As Treated|Proportion of participants with HIV-1 RNA < 200 copies/mL by week, as treated population.|Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48|As Treated: purely virologic missing=ignored. The numerator includes participants with HIV-1 RNA < 200 copies/mL and still on initial treatment; the denominator includes participants on initial treatment with an HIV-1 RNA evaluation at the given week.|||proportion of participants||95% Confidence Interval|Number
2566267|NCT02582684|Secondary|Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL- As Treated|Proportion of participants with HIV-1 RNA < 50 copies/mL by week, as treated population.|Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48|As Treated: purely virologic missing = ignored. The numerator includes participants with HIV-1 RNA < 50 copies/mL and still on initial treatment; the denominator includes participants on initial treatment with an HIV-1 RNA evaluation at the given week.|||proportion of participants||95% Confidence Interval|Number
2566268|NCT02582684|Secondary|Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- ITT Missing = Ignored|Proportion of participants with HIV-1 RNA < 200 copies/mL by week, ITT (missing = ignored) population.|Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48|ITT Missing = Ignored. The numerator includes participants with HIV-1 RNA < 200 copies/mL; the denominator includes all participants with an HIV-1 RNA evaluation at the given week.|||proportion of participants||95% Confidence Interval|Number
2566269|NCT02582684|Secondary|Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL - Missing = Ignored|Proportion of participants with HIV-1 RNA < 50 copies/mL by week, ITT (missing = ignored) population.|Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48|ITT Missing = Ignored. The numerator includes participants with HIV-1 RNA < 50 copies/mL; the denominator includes all participants with an HIV-1 RNA evaluation at the given week.|||proportion of participants||95% Confidence Interval|Number
2566270|NCT02582684|Secondary|Proportion of Participants With Plasma HIV-1 RNA < 200 Copies/mL - Missing = Failure|Proportion of participants with HIV-1 RNA < 200 copies/mL by week, ITT (missing/off study/off treatment = failure) population.|Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48|The population here is the ITT (missing/off study/off treatment = failure) population. The numerator includes participants with HIV-1 RNA < 200 copies/mL and still on initial treatment; the denominator includes all participants with potential for the given week of follow-up based on the date of registration.|||proportion of participants||95% Confidence Interval|Number
2566271|NCT02582684|Secondary|Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/mL - Missing = Failure|Proportion of participants with HIV-1 RNA < 50 copies/mL by week, ITT (Intention To Treat; missing/off study/off treatment = failure) population.|Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48|The population here is the ITT (missing/off study/off treatment = failure) population. The numerator includes participants with HIV-1 RNA < 50 copies/mL and still on initial treatment; the denominator includes all participants with potential for the given week of follow-up based on the date of registration.|||proportion of participants||95% Confidence Interval|Number
2566272|NCT02582684|Secondary|Virologic Failure|"Virologic failure is defined as follows:~Weeks 16 or 20: confirmed plasma HIV-1 RNA > 400 copies/mL~Week 24 or later: confirmed plasma HIV-1 RNA > 200 copies/mL~Participants were evaluated for virologic failure regardless of whether on study treatment.~Confirmation was determined based on any two consecutive evaluations meeting the virologic failure definition regardless of the time between them.~Participants discontinuing the study (for any reason, including death and lost to follow-up) were considered virologic failures if their last measurement met the definition of virologic failure but no confirmatory measurement was obtained. All other participants' follow-up was censored immediately after the last available plasma HIV-1 RNA measurement."|Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48|All eligible participants enrolled.|||Participants|||Count of Participants
2566273|NCT02582684|Secondary|Virologic Status at Week 48|"Numbers of Participants With Virologic Success, Virologic Non-Success, and no Virologic Data at Week 48 Window are provided below.~Virologic success is defined as HIV-1 RNA <50 copies/mL and on study treatment (FDA Snapshot definition)."|At 48 weeks after study entry|All eligible participants enrolled.|||Participants|||Count of Participants
2566274|NCT02582684|Secondary|Virologic Status at Week 12|"Numbers of Participants With Virologic Success, Virologic Non-Success, and no Virologic Data at Week 12 Window are provided below.~Virologic success is defined as HIV-1 RNA <50 copies/mL and on study treatment (FDA Snapshot definition)."|At 12 weeks after study entry|All eligible participants enrolled.|||Participants|||Count of Participants
2566275|NCT02582684|Primary|Virologic Status at Week 24|"Numbers of Participants With Virologic Success, Virologic Non-Success, and no Virologic Data at Week 24 Window are provided below.~Virologic success is defined as HIV-1 RNA <50 copies/mL and on study treatment (FDA Snapshot definition)."|At 24 weeks after study entry|All eligible participants enrolled.|||Participants|||Count of Participants
2566276|NCT02582671|Secondary|Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria|The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented.|12 weeks after the last actual dose of study drug|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants|||Number
2566277|NCT02582671|Secondary|Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria|Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure.|Up to 24 weeks|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype).|||percentage of participants|||Number
2566278|NCT02582671|Secondary|Percentage of Participants Meeting Relapse Criteria|Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment.|Up to 12 weeks after the last actual dose of study drug|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants|||Number
2566279|NCT02582671|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL).|Up to 24 weeks|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants|||Number
2566280|NCT02582671|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment.|Up to 24 weeks|Core population (those meeting inclusion criteria and treated according to the standard of care and w/in local label guidelines for specific disease characteristics [cirrhotic status, genotype]) who had at least 1 undetectable or unquantifiable, on-treatment HCV RNA measurement and at least 1 on-treatment or end of treatment measurement thereafter|||percentage of participants||95% Confidence Interval|Number
2566281|NCT02582671|Secondary|Percentage of Participants With Relapse|Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL.|From the end of treatment through the end of study (maximum of 48 weeks post-treatment)|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants||95% Confidence Interval|Number
2566282|NCT02582671|Secondary|Percentage of Participants With Virologic Response at End of Treatment (EOT)|Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment.|Up to 24 weeks|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||Percentage of participants||95% Confidence Interval|Number
2566283|NCT02582671|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|"SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria:~evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN~an HCV RNA value ≥50 IU/mL at the last measurement post-baseline~HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure"|12 weeks after the last actual dose of study drug|Core population (CP) and core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) are defined in the outcome measure description|||percentage of participants||95% Confidence Interval|Number
2566284|NCT02582658|Other Pre-specified|Percentage of Participants With Adherence to Planned ABBVIE Regimen Target Dose Taken|Adherence to the ABBVIE REGIMEN was defined as percentage of target dose (adherence=cumulated number of pills taken / [initially prescribed number of pills x planned duration]) and categorized as follows: >105%, >95% to <=105%, >80% to <=95%, >50% to <=80%, <=50%.|Up to 24 weeks of treatment|Core Population (CP)|||percentage of participants|||Number
2566285|NCT02582658|Other Pre-specified|Percentage of Participants Deviating From the Target ABBVIE Regimen Duration|Deviations from the target dose of the ABBVIE REGIMEN were defined as the actual duration is shortened/prolonged (exceedence) for more than 7 days.|Up to 24 weeks of treatment|Core Population (CP)|||percentage of participants|||Number
2566286|NCT02582658|Other Pre-specified|Percentage of Participants With Adherence to Planned RBV Target Dose Taken|Adherence to RBV is defined as percentage of target dose (adherence=cumulated number of pills taken / [initially prescribed number of pills x planned duration]) and categorized as follows: >105%, >95% - <=105%, >80% - <=95%, >50% - <=80%, <=50%.|Up to 24 weeks of treatment|All participants in the Core Population (CP) who received RBV|||percentage of participants|||Number
2566287|NCT02582658|Other Pre-specified|Patient Support Program (PSP) Utilization and Satisfaction Assessment|The AbbVie PSP included educational and information material (including printed, online, pillbox), digital and mobile resource (web-portal), digital and mobile resources (reminders). The PSP utilization and satisfaction assessment evaluated the frequency of utilization (usually daily, several times per week, usually once weekly, less than once weekly) and patient's overall satisfaction (very good, good, satisfactory) with their respective PSP.|Up to 24 weeks of treatment|Core Population (CP)|||percentage of participants|||Number
2566288|NCT02582658|Other Pre-specified|Change in Mean Score From Baseline to 12 Weeks After End of Treatment (EOT) in Work Productivity and Activity Impairment (WPAI) Version 2: Hepatitis C Questionnaire|The WPAI questionnaire was used to measure work absenteeism, work presenteeism, work productivity impairment and daily activity impairment. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity: Presenteeism - percentage of impairment while working due to health problem; Total work productivity impairment - percentage of overall work impairment due to health problem Absenteeism - percentage of work time missed due to health problem; Total activity impairment - percentage of general (non-work) activity impairment due to health problem|Day 0 to post treatment week 12|Core Population (CP)|||percentage||Standard Deviation|Mean
2566322|NCT02582242|Secondary|7-point SMPG Profiles: Change From Baseline in PPG Increment at Individual Meal (Breakfast, Lunch and Main Evening Meal)|Change from baseline in PPG increment at individual meal (breakfast, lunch and main evening meal) was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method.|Week 0, Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at specified time points.|||mmol/L||Standard Deviation|Mean
2566289|NCT02582658|Other Pre-specified|Quality of Life Measured With the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire|The EQ-5D-5L is a health state utility instrument that evaluates preference for health status (utility). The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. The EQ-5D visual analogue scale (VAS) records the participant's self-rated health status on a vertical graduated scale from 0 to 100, with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state. An increase in EQ-5D-5L VAS score indicates improvement.|Day 0 and post treatment week 12|Core Population (CP)|||score on a scale||Standard Deviation|Mean
2566290|NCT02582658|Other Pre-specified|Percentage of Participants With Co-morbidities and/or Co-infections|Percentage of participants with co-morbidities and/or co-infections at baseline (Day 0).|Day 0|Core Population (CP)|||percentage of participants|||Number
2566291|NCT02582658|Other Pre-specified|Percentage of Participants With Concomitant Medications|Percentage of participants taking at least 1 concomitant medication|Day 0 to end of treatment (up to 24 weeks)|The safety population (SP) was defined as enrolled patients who received at least 1 dose of ABBVIE REGIMEN.|||percentage of participants|||Number
2566292|NCT02582658|Other Pre-specified|Total Score of Participant Activation According to the Patient Activation Measure (PAM-13) Questionnaire|"The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Each of the 13 items can be answered with one of four possible response options, which are disagree strongly (1), disagree (2), agree (3), agree strongly (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4. The responses to the 13 questions are summed and transformed into a PAM Score between 0 and 100; a higher score indicates more knowledge and confidence to take action for self-management."|Day 0 and End of Treatment (EoT)|Core Population (CP)|||score on a scale||Standard Deviation|Mean
2566293|NCT02582658|Other Pre-specified|Percentage of Planned Duration of Ribavirin (RBV) Taken|Adherence to RBV is defined as percentage of target dose (adherence=cumulated dose taken/ [initially prescribed dose x planned duration]).|Up to 24 weeks of treatment|All participants in the Core Population (CP) who received RBV|||percentage of planned RBV dose taken||Standard Deviation|Mean
2566294|NCT02582658|Secondary|Percentage of Participants With Post-treatment Relapse|The percentage of participants with relapse (defined as HCV RNA <50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL)|Up to 12 weeks after last dose of study drug|Core Population (CP)|||percentage of participants|||Number
2566295|NCT02582658|Secondary|Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up)|SVR12 is defined as HCV RNA levels < 50 IU/mL 12 weeks after the last actual dose of study drug in the Core Population Sufficient Follow-up (CPSFU).|12 weeks after last dose of study drug|CP subjects with evaluable HCV RNA data ≥70 days after last dose AbbVie Regimen, or HCV RNA value ≥50IU/mL at last measurement postbaseline, or HCV RNA <50IU /mL at last measurement postbaseline, but no HCV RNA value ≥70 days after last dose AbbVie Regimen due to safety or virologic failure (relapse reported but date/value of HCV RNA test missing).|||percentage of participants||95% Confidence Interval|Number
2566296|NCT02582658|Secondary|Percentage of Participants With On-treatment Virologic Failure (Breakthrough)|The percentage of participants with on-treatment virologic failure (breakthrough [defined as at least one documented HCV RNA <50 IU/mL followed by HCV RNA >= 50 IU/mL during treatment]).|Up to approximately 24 weeks|Core Population (CP)|||percentage of participants|||Number
2566297|NCT02582658|Secondary|Percentage of Participants With Virological Response at End of Treatment (EoTR)|The percentage of participants with virological response (HCV RNA <50 IU/mL) at end of treatment (EoT, defined as last intake of ABBVIE REGIMEN or ribavirin [RBV]).|Up to 24 weeks of treatment|Core Population (CP)|||percentage of participants||95% Confidence Interval|Number
2566298|NCT02582658|Primary|Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12)|SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL 12 weeks after the last actual dose of study drug.|12 Weeks after the last dose of study drug|The Core Population (CP) was defined as all patients in the safety population (SP; all enrolled subjects who received at least 1 dose of study drug) who met eligibility criteria and were adequately treated according to the standard of care and within local label recommendations.|||percentage of participants||95% Confidence Interval|Number
2566299|NCT02582632|Other Pre-specified|Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12: mITT-GT Population|SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.|Baseline and 12 weeks after the last actual dose of study drug|The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection; participants with baseline HCV RNA < 6,000,000 IU/mL. Flanking imputation.|||percentage of participants||95% Confidence Interval|Number
2566300|NCT02582632|Other Pre-specified|Percentage of Female Participants Responding With SVR12: mITT-GT Population|SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.|12 weeks after the last actual dose of study drug|The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection; female participants. Flanking imputation.|||percentage of participants||95% Confidence Interval|Number
2566323|NCT02582242|Secondary|7-point SMPG Profiles: Change From Baseline in 2-hour PPG at Individual Meal (Breakfast, Lunch and Main Evening Meal)|Change from baseline in 2-hour postprandial glucose (PPG) at individual meal (breakfast, lunch and main evening meal) was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method.|Week 0, Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at specified time points.|||mmol/L||Standard Deviation|Mean
2566301|NCT02582632|Other Pre-specified|Percentage of Participants With Post-Treatment Relapse12: mITT-GT Population|Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution.|Up to 12 weeks after last dose of study drug|The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection. Participants who did not complete treatment or had no post treatment data available or had HCV RNA ≥ LLOQ at the Final Treatment Visit were not included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2566302|NCT02582632|Other Pre-specified|Percentage of Participants With On-Treatment Virologic Failure During Treatment Period: mITT-GT Population|On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the Wilson score method.|Up to 8 weeks while on treatment|The mITT-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection.|||percentage of participants||95% Confidence Interval|Number
2566303|NCT02582632|Other Pre-specified|Percentage of Participants Who Achieve SVR12: mITT-GT Population|SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.|12 weeks after the last actual dose of study drug|The modified ITT (mITT)-GT population includes participants who received at least 1 dose of study drug but excludes the participants who do not have HCV GT1b infection. Flanking imputation.|||percentage of participants||95% Confidence Interval|Number
2566304|NCT02582632|Secondary|Percentage of Participants With Baseline HCV RNA < 6,000,000 IU/mL Responding With SVR12|SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.|Baseline and 12 weeks after the last actual dose of study drug|ITT population: all enrolled participants who received at least 1 dose of study drug and with baseline HCV RNA < 6,000,000 IU/mL. Flanking imputation.|||percentage of participants||95% Confidence Interval|Number
2566305|NCT02582632|Secondary|Percentage of Female Participants Responding With SVR12|SVR12 is defined as HCV RNA < LLOQ 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.|12 weeks after the last actual dose of study drug|ITT population: all enrolled female participants who received at least 1 dose of study drug. Flanking imputation.|||percentage of participants||95% Confidence Interval|Number
2566306|NCT02582632|Secondary|Percentage of Participants With Post-Treatment Relapse12|Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) excluding reinfection among participants with HCV RNA < LLOQ at final treatment visit who complete treatment and have post-treatment HCV RNA data. Completion of treatment is defined as a study drug duration ≥ 51 days for participants who receive 8 weeks of treatment. HCV reinfection is defined as confirmed HCV RNA ≥ LLOQ after the end of treatment in a participant who had HCV RNA < LLOQ at final treatment visit, along with the post treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis of the NS3 or NS5A, and/or NS5B gene sequences. Confidence interval calculated using the normal approximation to the binomial distribution.|Up to 12 weeks after last dose of study drug|ITT population: all enrolled participants who received at least 1 dose of study drug. Participants who did not complete treatment or had no post treatment data available or had HCV RNA ≥ LLOQ at the Final Treatment Visit were not included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2566307|NCT02582632|Secondary|Percentage of Participants With On-Treatment Virologic Failure During Treatment Period|On-treatment virologic failure is defined as breakthrough (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA (two consecutive HCV rna measurements > 1 log^10 IU/mL above nadir) at any time point during treatment) or failure to suppress during treatment (all on-treatment values of HCV RNA ≥ LLOQ) with at least 6 weeks (defined as study drug duration ≥ 36 days) of treatment. Confidence interval calculated using the normal approximation to the binomial distribution.|Up to 8 weeks while on treatment|ITT population: all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2566308|NCT02582632|Primary|Percentage of Participants Who Achieve Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks after the last dose of study drugs without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Confidence interval calculated using the normal approximation to the binomial distribution.|12 weeks after the last actual dose of study drug|Intent to Treat (ITT) population: all enrolled participants who received at least 1 dose of study drug. Flanking imputation.|||percentage of participants||95% Confidence Interval|Number
2566337|NCT02582151|Primary|Patient Perception of Bladder Condition Questionnaire|Patient perception of bladder condition (PPBC) question. It is scored from 0 (My bladder condition does not cause me any problems at all) to 5 (My bladder condition causes me many severe problems). Higher numbers are worse outcomes.|3 months||||units on a scale||Inter-Quartile Range|Median
2567015|NCT02573012|Secondary|Time to First Administration of Flare Rescue Medication|Time of onset of first administration of RA flare rescue medication since randomization date|Randomization to 24 weeks||||Weeks||Standard Deviation|Mean
2566309|NCT02582515|Primary|Hopkins Motor/Vocal Tic Scale (HM/VTS)|"Participants can nominate up to five motor and five vocal tics they deem bothersome on the HM/VTS. Each bothersome tic is then rated by a clinician on a 5-point scale ranging from none (0) to severe (4).~The individual tic scores are summed (minimum of 0 and maximum of 40) and averaged together to create an average tic severity score. Lower scores represent less tic severity, and higher scores indicate greater tic severity.~The primary outcome will be the difference in the average score of the two bothersome tics on the HM/VTS that were targeted in treatment (range: 0-8). Change scores were calculated by subtracting the average of the two bothersome tics on the HM/VTS at post-treatment from the average of the two bothersome tics on the HM/VTS at the pre-treatment assessment. Positive scores indicate improvement/decrease in targeted tic severity, with negative scores indicating increase in targeted tic severity"|Pre-treatment, One Week post-treatment||||score on a scale||Standard Deviation|Mean
2566310|NCT02582255|Secondary|Incidence of Any Serious Adverse Events (SAEs), Any Solicited AEs, Any Unsolicited AEs, and Any Important Medical Events (IMEs).|Incidence, severity and relationship) of any serious adverse events (SAEs), any solicited AEs, any unsolicited AEs, and any Important Medical Events (IMEs) with the exception of severe related AEs. (primary objective), as well as any laboratory deviations of one or two doses of SABIN mOPV2 in healthy IPV-vaccinated children aged 1 to 5 years.|3 months|All subjects receiving at least one dose of vaccine.|||Participants|||Count of Participants
2566311|NCT02582255|Secondary|Seroprotection Rate for Type 2 Polio Neutralizing Antibodies.|Seroprotection rate for type 2 polio neutralizing antibodies measured at D 28 after the secon dose of mOPV2.|3 months|All subjects receiving two doses of vaccine.|||Participants|||Count of Participants
2566312|NCT02582255|Primary|Seroprotection Rate of Type 2 Polio Neutralizing Antibodies.|Seroprotection rate at type 2 polio neutralizing antibodies measured at D28 after the first dose of mOPV2.|1 month|All participants who received two doses of vaccines.|||Participants|||Count of Participants
2566313|NCT02582255|Primary|SAEs and Severe AEs|Incidence of SAEs and severe AEs grade 3 considered consistent with a causal association to study vaccine throughout the study period in children 1 to 5 years.|3 months|All participants who received at least one dose of vaccine.|||Participants|||Count of Participants
2566314|NCT02582242|Secondary|Change From Baseline in Patient-reported Treatment Satisfaction as Assessed by the Diabetes Treatment Satisfaction Questionnaire (Status) (DTSQs)|Change from baseline in patient-reported treatment satisfaction (as assessed by the DTSQs) was evaluated after 24 weeks of treatment. The DTSQs is a self-completion questionnaire used to investigate the subject's treatment satisfaction. The DTSQ contained 8 questions, which were scored on a scale from 0 to 6. Out of 8 questions, 6 were related to the overall treatment satisfaction and 2 were related to glycaemic control (hypoglycaemia and hyperglycaemia). Results for the 6 questions relating to overall treatment satisfaction are presented together whereas the 2 questions relating to blood glucose are presented separately. For the overall treatment satisfaction, a higher score (0−36) was related to a better perception of treatment satisfaction. For hypoglycaemia and hyperglycaemia, a lower score (0−6) was related to a better blood glucose control. Missing data was imputed using the LOCF method.|Week 0, Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data.|||Score on a scale||Full Range|Median
2566315|NCT02582242|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method.|Week 0, Week 24|Safety analysis set included all subjects who received at least one dose of investigational product (BIAsp 30).|||Kilogram (kg)||Standard Deviation|Mean
2566316|NCT02582242|Secondary|Total Daily Insulin Dose|Total daily insulin dose was the sum of doses given before breakfast and before main evening meal for the BID treatment group, and the sum of doses given before breakfast, before lunch and before main evening meal for the TID treatment group. Missing data was imputed using the LOCF method.|Week 1, Week 24|Safety analysis set included all subjects who received at least one dose of investigational product (BIAsp 30). Number analyzed = number of subjects contributed to the evaluation at the specified time point.|||Units (U)||Standard Deviation|Mean
2566317|NCT02582242|Secondary|Incidence of Treatment Emergent Adverse Events (TEAEs)|Incidence of TEAEs was recorded during 24 weeks of treatment. A TEAE was defined as an event that has onset date (or increase in severity) on or after the first day of exposure to trial product (in week 0) and no later than 7 days after the last day on trial product.|Week 0-24|Safety analysis set included all subjects who received at least one dose of investigational product (BIAsp 30). Number analyzed = number of subjects with corresponding numbers of TEAEs.|||Number of adverse events|||Number
2566318|NCT02582242|Secondary|7-point SMPG Profiles: Fluctuation in the 7-point Profile|Fluctuation in the 7-point SMPG profile was evaluated after 24 weeks of treatment. Fluctuation in 7-point SMPG profile was the average absolute difference to the mean of the profile of the 7-point SMPG measurements accumulated over the profile. Missing data was imputed using the LOCF method.|Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at the specified time point.|||mmol/L||Geometric Coefficient of Variation|Geometric Mean
2566319|NCT02582242|Secondary|7-point SMPG Profiles: Change From Baseline in Mean of the 7-point Profile|Change from baseline in mean of the 7-point SMPG profiles was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method.|Week 0, Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at the specified time point.|||mmol/L||Standard Deviation|Mean
2566320|NCT02582242|Secondary|7-point SMPG Profiles: Change From Baseline in Mean of PPG Increment Over 3 Main Meals (Breakfast, Lunch and Main Evening Meal)|Change from baseline in mean of PPG increment at individual meal (breakfast, lunch and main evening meal) was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method.|Week 0, Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data.|||mmol/L||Standard Deviation|Mean
2566321|NCT02582242|Secondary|7-point SMPG Profiles: Change From Baseline in Mean of 2-hour PPG Over 3 Main Meals (Breakfast, Lunch and Main Evening Meal)|Change from baseline in mean of 2-hour PPG at individual meal (breakfast, lunch and main evening meal) was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method.|Week 0, Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at the specified time point.|||mmol/L||Standard Deviation|Mean
2566324|NCT02582242|Secondary|7-point SMPG Profile|"7-point self-measured plasma glucose (SMPG) profiles was evaluated after 24 weeks of treatment.~Subjects were instructed to perform the following SMPG measurements:~Before breakfast.~120 minutes after the start of breakfast.~Before lunch.~120 minutes after the start of lunch.~Before main evening meal.~120 minutes after the start of main evening meal.~At bedtime. Missing data was imputed using the LOCF method."|Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at specified time points.|||mmol/L||Standard Deviation|Mean
2566325|NCT02582242|Secondary|Change From Baseline in FPG by Central Laboratory Analysis|Change from baseline in fasting plasma glucose (FPG) by central laboratory analysis was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method.|Week 0, Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at the specified time point.|||mmol/L||Standard Deviation|Mean
2566326|NCT02582242|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes Classified According to Novo Nordisk Definition|"Treatment emergent hypoglycaemic episodes were defined as the hypoglycaemic episodes, which occurred on or after the first day of trial product administration (in week 0), and no later than 7 days after the last day on trial product.~Novo Nordisk (NN) classification of hypoglycaemia:~Severe hypoglycaemia: According to the ADA classification.~Blood glucose (BG) confirmed hypoglycaemia: an episode that is BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.~Severe or BG confirmed hypoglycaemia: an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia."|Week 0-24|Safety analysis set included all subjects who received at least one dose of investigational product (BIAsp 30).|||Count of hypoglycaemic episodes|||Number
2566327|NCT02582242|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition|"ADA classification of hypoglycaemia:~Severe:Episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. PG concentrations may not be available during event, but neurological recovery following return of PG to normal is considered sufficient evidence that the event was induced by low PG concentration~Asymptomatic:Episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L~Documented symptomatic:Episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤3.9 mmol/L~Pseudo:Episode during which person with diabetes reports any of the typical symptoms of hypoglycaemia with measured PG concentration >3.9 mmol/L but approaching that level~Probable symptomatic:Episode during which symptoms of hypoglycaemia are not accompanied by PG determination but that was presumably caused by a PG concentration ≤3.9 mmol/L"|Week 0-24|Safety analysis set included all subjects who received at least one dose of investigational product (BIAsp 30). Treatment emergent hypoglycaemic episodes were defined as the hypoglycaemic episodes, which occurred on or after the first day of trial product administration (in week 0), and no later than 7 days after the last day on trial product.|||Count of hypoglycaemic episodes|||Number
2566328|NCT02582242|Secondary|Proportion of Subjects Achieving HbA1c Below 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes (According to the Novo Nordisk Classification)|Percentage of subjects achieving HbA1c <7.0% (yes or no) without severe or BG confirmed hypoglycaemic episodes (according to the Novo Nordisk classification) was evaluated after 24 weeks of treatment. Severe or BG confirmed hypoglycaemia: an episode that is severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose (PG) value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA: Episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. PG concentrations may not be available during event, but neurological recovery following return of PG to normal is considered sufficient evidence that the event was induced by low PG concentration.|Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data.|||Percentage (%) of participants|||Number
2566329|NCT02582242|Secondary|Proportion of Subjects Achieving HbA1c Below 7.0% Without Severe Hypoglycaemic Episodes.|Percentage of subjects achieving HbA1c <7.0% (yes or no) without severe hypoglycaemic episodes was evaluated after 24 weeks of treatment. Severe hypoglycaemia: Episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during event, but neurological recovery following return of PG to normal is considered sufficient evidence that the event was induced by low PG concentration.|Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data.|||Percentage (%) of participants|||Number
2566330|NCT02582242|Secondary|Proportion of Subjects Achieving HbA1c Below 7.0%|Percentage of subjects achieving HbA1c <7.0% (yes or no) was evaluated after 24 weeks of treatment.|Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data.|||Percentage (%) of participants|||Number
2566331|NCT02582242|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c was evaluated after 24 weeks of treatment. Missing data was imputed using the last observation carried forward (LOCF) method.|Week 0, Week 24|FAS included all randomised subjects who were dosed and had any post randomisation data.|||Percentage (%) of HbA1c||Standard Deviation|Mean
2566332|NCT02582151|Secondary|Physician Assessment of Patient Benefit (Global Response Scale)|Completed by physicians based on their assessment after discussion with the patient as to the amount of benefit they received. Reported on a scale of 0 (no benefit) to 7 (substantial benefit)|3 months||||units on a scale||Inter-Quartile Range|Median
2566333|NCT02582151|Secondary|24hr Incontinence Pad Weights||3 months||||grams||Inter-Quartile Range|Median
2566334|NCT02582151|Secondary|3-day Voiding Diary|Daily urinary frequency as recorded by the patient over 3 days. Summarised as an average daily frequency.|3 months||||voids per 24 hrs||Inter-Quartile Range|Median
2566335|NCT02582151|Secondary|Qualiveen-Short Form Questionnaire|Patient reported questionnaire that measures quality of life among neurogenic bladder patients. Score ranges from 0 to 32. A higher score is worse.|3 months||||units on a scale||Inter-Quartile Range|Median
2566336|NCT02582151|Secondary|Neurogenic Bladder Symptom Score (NBSS) Questionnaire|The NBSS is a patient reported symptom score covering three domains: incontinence, storage/voiding, and consequences. It is scored from 0 to 72, and a higher score is worse outcome.|3 months||||Units on a scale||Inter-Quartile Range|Median
2566338|NCT02581995|Other Pre-specified|Change From Baseline in Body Temperature at Week 52|Temperature was measured in a consistent and standardized way according to locally established practice.|Baseline, Week 52|SAF included all participants who received at least 1 injection of study drug. Participants who were evaluable for this measure at given time point for the arm were included in the category.|||celsius||Standard Deviation|Mean
2566339|NCT02581995|Other Pre-specified|Change From Baseline in Heart Rate at Week 52|Heart rate was measured in a consistent and standardized way according to locally established practice.|Baseline, Week 52|SAF included all participants who received at least 1 injection of study drug. Participants who were evaluable for this measure at given time point for the arm were included in the category.|||beats per minute (beats/min)||Standard Deviation|Mean
2566340|NCT02581995|Other Pre-specified|Change From Baseline in Diastolic Blood Pressure at Week 52|Diastolic blood pressure was measured in a consistent and standardized way according to locally established practice.|Baseline, Week 52|SAF included all participants who received at least 1 injection of study drug. Participants who were evaluable for this measure at given time point for the arm were included in the category.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2566341|NCT02581995|Other Pre-specified|Change From Baseline in Systolic Blood Pressure at Week 52|Systolic blood pressure was measured in a consistent and standardized way according to locally established practice.|Baseline, Week 52|SAF included all participants who received at least 1 injection of study drug. Participants who were evaluable for this measure at given time point for the arm were included in the category.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2566342|NCT02581995|Other Pre-specified|Change From Baseline in Pre-injection Intraocular Pressure for Study Eye Every 4 Weeks|Intraocular pressure (IOP) was measured using applanation tonometry Goldmann, Tonopen or approved alternative). The same method of intraocular pressure measurement was used in each participant throughout the study. For the measurement of intraocular pressure, a local anesthetic combined with fluorescein was applied topically to the eye being tested (example: one drop of oxybuprocain plus fluorescein). In the below table, pre-injection intraocular pressure for study eye was reported.|Baseline, Weeks 4, 8, 12, 16, 24, 32, 40, 48, 52|SAF included all participants who received at least 1 injection of study drug. Participants who were evaluable for this measure at given time points for the arm were included in the categories.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2566343|NCT02581995|Secondary|Proportion of Participants Progressing to Greater or Equal to (>=) 61 on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) as Assessed by Fundus Photography (FP)|"The ETDRS DRSS was assessed by FP according to the following scale for both eyes. The following severities are possible.~10 = Diabetic retinopathy (DR) absent, 14 = DR questionable, 15 = DR questionable, 20 = Micro-aneurysms only, 35 = Mild Non-proliferative diabetic retinopathy (NPDR), 43 = Moderate NPDR, 47 = Moderately severe NPDR, 53 = Severe NPDR, 61 = Mild Proliferative diabetic retinopathy (PDR), 65 = Moderate PDR, 71 = High-risk PDR, 75 = High-risk PDR, 81 = Advanced PDR: fundus partially obscured, center of macula attached, 85 = Advanced PDR: posterior fundus obscured, or center of macula detached, 90 = cannot grade, even sufficiently for level 81 or 85."|Baseline, Week 52|Subjects in the FAS with gradable baseline and Week 52 FP and a DRSS of less than (<) 61 at baseline. Participants who were evaluable for this measure at given time point for the arm were included in the category.|||proportion of participants|||Number
2566344|NCT02581995|Secondary|Change From Baseline to Week 52 in Central Retinal Thickness (CRT) Measured by Optical Coherence Tomography (OCT)|Retinal and lesion characteristics were evaluated using spectral domain optical coherence tomography (OCT). For all visits where the OCT procedure was scheduled, images were captured and read by the investigator. All OCTs were electronically archived at the study sites as part of the source documentation.|Baseline, Week 52|FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire. Participants who were evaluable for this measure at given time point for the arm were included in the category.|||microns||95% Confidence Interval|Mean
2566345|NCT02581995|Secondary|Change From Baseline to Week 52 in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score])|Visual function was assessed using the ETDRS protocol (Early Treatment Diabetic Retinopathy Study Research Group 1985) starting at 4 meters. The values might range from 0 to 100. A higher score represents better functioning.|Baseline, Week 52|FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.|||score on a scale||95% Confidence Interval|Mean
2566346|NCT02581995|Secondary|Change From Baseline to Week 52 in the NEI VFQ 25 Distant Activities Subscale|"NEI VFQ-25 is a condition-specific measure which was designed to capture the specific impact of vision loss on HRQoL. The calculation for NEI VFQ-25 sub-scale scores and total score was performed according to the NEI VFQ-25 Scoring Algorithm - August 2000. Items within each sub-scale are averaged together to create the 12 sub-scale Scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Sub-scales with at least one item answered can be used to generate a sub-scale score. Hence, scores represent the average for all items in the subscale that the respondent answered. The NEI VFQ-25 distant activities subscale was scored from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. Distant activities are defined as activities requiring distance vision, such as recognizing faces or reading street signs."|Baseline, Week 52|FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.|||score on a scale||95% Confidence Interval|Mean
2566363|NCT02581488|Other Pre-specified|Time to Closure for Ulcers Achieving Closure by End of Follow-up|Days to closure for ulcers that closed by end of follow-up period.|10 weeks||||days||Standard Deviation|Mean
2566364|NCT02581488|Other Pre-specified|Time to Closure for Ulcers Achieving Closure in Treatment Period|Days to closure for ulcers that closed by end of treatment period.|6 weeks||||days||Standard Deviation|Mean
2566365|NCT02581488|Secondary|Target Ulcer Infection Rates in Each Treatment Group During the Treatment Period as Determined by Investigator-reported Adverse Events||6 weeks||||Participants|||Count of Participants
2566366|NCT02581488|Primary|Mean Percent Change in Ulcer Area From Baseline to the End of the Treatment.|Ulcer area was measured using the ARANZ Silhouette digital imaging and measurement device.|6 weeks||||percentage of change from baseline (cm2)||Standard Deviation|Mean
2566347|NCT02581995|Secondary|Change From Baseline to Week 52 in the NEI VFQ 25 Near Activities Subscale|"NEI VFQ-25 is a condition-specific measure which was designed to capture the specific impact of vision loss on HRQoL. The calculation for NEI VFQ-25 sub-scale scores and total score was performed according to the NEI VFQ-25 Scoring Algorithm - August 2000. Items within each sub-scale are averaged together to create the 12 sub-scale Scores. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Sub-scales with at least one item answered can be used to generate a sub-scale score. Hence, scores represent the average for all items in the subscale that the respondent answered.The NEI VFQ-25 near activities subscale was scored from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf."|Baseline, Week 52|FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.|||score on a scale||95% Confidence Interval|Mean
2566348|NCT02581995|Primary|Change From Baseline to Week 52 in NEI VFQ-25 Total Score|"National eye institute 25-item visual function questionnaire (NEI VFQ-25) is a condition-specific measure which was designed to capture the specific impact of vision loss on health-related quality of life (HRQoL). The calculation for NEI VFQ-25 sub-scale scores and total score was performed according to the NEI VFQ-25 Scoring Algorithm - August 2000. The NEI VFQ-25 consists of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. In this format scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score."|Baseline, Week 52|FAS included all participants who received at least one injection of study drug and completed the baseline and at least one post-baseline NEI VFQ-25 questionnaire.|||score on a scale||95% Confidence Interval|Mean
2566349|NCT02581930|Other Pre-specified|Pharmacokinetic Analysis on Ibrutinib Concentrations in Plasma Using WinNonlin|The following parameters will be estimated: maximum concentration, time of maximum concentration, area under the concentration verses time curve, half-life, apparent clearance, apparent volume of distribution.|Pre-dose on days 1 and day 8 of course 1 and post-dose, 0.5, 1, 2, 4, 6, and 24 hours on day 8 of course 1|||||||
2566350|NCT02581930|Other Pre-specified|Change in Th1, Th2, and Various Immune Regulatory Cell Populations in Peripheral Blood Mononuclear Cells and Assessed by Flow Cytometry|Will be assessed by comparisons using analysis of variance followed by paired t-test or other tests (Wilcoxon rank-sum test), if normality assumption is not satisfied even when data transformation is performed.|Baseline up to 1 year|||||||
2566351|NCT02581930|Other Pre-specified|Expression Levels of ITK and Putative Targets of Ibrutinib (e.g. Tec, ErbB4, Hck, Yes, BTK)|Assessed by IHC and 2-color IF and analyzed by Aperio imaging. Exploratory analysis will also be performed to assess the predictive ability of each tissue biomarker by fitting logistic model or Cox model with biomarker as a covariate. Antitumor response rate or PFS information will be used to investigate possible cut-points for the biomarker. Logistic regression analysis will be conducted to assess whether a profile of immune response in tumor biopsies (or in peripheral blood) can be developed that distinguishes patients who respond to treatment versus those who do not.|Up to 1 year|||||||
2566352|NCT02581930|Secondary|Overall Survival|Estimated using the Kaplan Meier method.|Duration of time from day 1 of treatment to death as a result of any cause, assessed up to 1 year||||months||Full Range|Median
2566353|NCT02581930|Secondary|Progression Free Survival|Progression free survival (PFS) is defined as the duration of time from Day 1 of treatment to time of progression (based on clinical or radiographic grounds) or death as a result of any cause, whichever occurs first.|1 year||||months||Full Range|Median
2566354|NCT02581930|Primary|Number of Subjects With Antitumor Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria 1.1|Antitumor response defined as the sum of complete response (CR) and partial response (PR). CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (<1 cm). PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|1 year||||Participants|||Count of Participants
2566355|NCT02581839|Secondary|Median Overall Survival (OS)|The study team will generate a Kaplan-Meier curve of OS.|up to 2 years from start of treatment||||months||Full Range|Median
2566356|NCT02581839|Secondary|Systemic Disease Response Rate|The study team will estimate systemic disease response rate (and 95% CI) and perform a Kaplan-Meier analysis for systemic response in this patient population|up to 2 years from start of treatment|Data not collected due to too few participants on study for a significant length of time||||||
2566357|NCT02581839|Secondary|Number of Patients With CBR|The study team will sum the proportion of the patients with complete response, partial response and stable disease at 12 weeks (CBR)|At 12 weeks||||Participants|||Count of Participants
2566358|NCT02581839|Secondary|Number of Patients Treated With Eribulin Who Experienced Serious Adverse Events|The study team will evaluate rates (and 95% CI) of toxicity in patients treated with eribulin.|up to 2 years from start of treatment||||Participants|||Count of Participants
2566359|NCT02581839|Secondary|Median Duration of CNS Response|The study team will calculate the duration of CNS response. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.|up to 2 years from start of treatment||||weeks||Full Range|Median
2566360|NCT02581839|Secondary|Objective Response Rate (RR)|The study team will calculate the percent of participants with complete and partial response. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.|up to 2 years from start of treatment||||percentage of participants|||Number
2566361|NCT02581839|Primary|Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS)|The study team will assess the percent of participants without CNS progression at 3 months. The study team will generate a Kaplan- Meier curve of CNS PFS and estimate the PFS and 95% confidence interval (CI) of the PFS. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.|At 12 weeks||||percentage of participants||95% Confidence Interval|Number
2566362|NCT02581488|Post-Hoc|Incidence of Debridements During Treatment Period|Number of debridements performed during the treatment period by treatment group.|6 weeks||||occurences|||Number
2566367|NCT02581475|Secondary|Adenomas Per Patient in the Proximal Colon Among 2 Group.||During routine screening and surveillance colonoscopy, for up toafter 1 hour, the number of adenomas was recorded. About 1 month after this study, mean number of adenomas in proximal colon was calculated.||||adenomas per patient||Standard Deviation|Mean
2566368|NCT02581475|Secondary|Duration of the Total Colonoscopy Among 2 Group.||During routine screening and surveillance colonoscopy, for up to 1 hour, the duration of colonoscopy was recorded. About 1 month after this study, mean duration of the colonoscopy was calculated.||||minute||Standard Deviation|Mean
2566369|NCT02581475|Secondary|Withdrawal Time in the Proximal Colon Among 2 Group.||During routine screening and surveillance colonoscopy, for up to 1 hour, withdrawal time was recorded. About 1 month after this study, mean withdrawal time was calculated.||||minute||Standard Deviation|Mean
2566370|NCT02581475|Primary|Difference of Adenoma Detection Rate in the Proximal Colon Among 2 Group.|Adenoma detection rate in the proximal colon was the proportion of participants wiht more than one adenomas in proximal colon.|During routine screening and surveillance colonoscopy, for up to 1 hour, number of adenomas was recorded. About 1 month after this study, adenoma detetion rates were calculated.||||proportion of participants||95% Confidence Interval|Number
2566371|NCT02581410|Secondary|Number of Subjects With Any pIMDs|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From 30 days post last vaccination (Month 3) until study end at Month 14|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2566372|NCT02581410|Secondary|Number of Subjects With Any and Related SAEs|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as related to the vaccination.|From 30 days post last vaccination (Month 3) until study end at Month 14|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2566373|NCT02581410|Secondary|Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells|gE-specific CD4+ T-cells, expressing at least two activation markers (from among interferon gamma [IFN-γ], interleukin-2 [IL-2], tumour necrosis factor alpha [TNF-α] and cluster of differentiation 40-ligand [CD40L]), as determined by in vitro Intracellular Cytokine Staining (ICS).|At Months 0, 1, 3 and 14.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available up to Month 14.|||CD4+ T-cells/million T-cells||Standard Deviation|Mean
2566374|NCT02581410|Secondary|Anti-gE Ab Concentrations|VZV gE IgG antibody concentrations were determined by ELISA. Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).|At Months 0, 1, 3 and 14.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available up to Month 14.|||mIU/mL||95% Confidence Interval|Geometric Mean
2566375|NCT02581410|Primary|Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2566376|NCT02581410|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as related to the vaccination.|From first vaccination (Month 0) up to 30 days post last vaccination (Month 3)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2566377|NCT02581410|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Symptoms (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) period after each dose.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2566378|NCT02581410|Primary|Number of Days With Solicited General Symptoms|Solicited general symptoms were assessed during the 7-day (Days 0-6) period after each dose.|During the 7-day (Days 0-6) period after each dose.|The analysis was performed on subjects with solicited general symptoms from the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.|||Days||Inter-Quartile Range|Median
2566379|NCT02581410|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)] . Any = Occurrence of the symptom regardless of its intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) period after each dose.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.|||Participants|||Count of Participants
2567016|NCT02573012|Secondary|Percentage of Participants With >=1 Administration of Flare Rescue Medication|The proportion of participants with at least one administration of RA flare rescue medication.|Randomization to 24 weeks||||Percentage of Participants|||Number
2566380|NCT02581410|Primary|Number of Days With Solicited Local Symptoms|Solicited local symptoms were assessed during the 7-day (Days 0-6) period after each dose.|During the 7-day (Days 0-6) period after each dose.|The analysis was performed on subjects with solicited local symptoms from the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.|||Days||Inter-Quartile Range|Median
2566381|NCT02581410|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of the symptom regardless of its intensity grade. Grade 3 pain = Significant pain at rest that prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) period after each dose.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptom sheets filled in.|||Participants|||Count of Participants
2566382|NCT02581410|Primary|Anti-glycoprotein E (Anti-gE) Antibody (Ab) Concentrations|Varicella Zoster Virus (VZV) gE Ab.Immunoglobulin G (IgG) was determined by Enzyme Linked Immunosorbent Assay (ELISA). Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL). Geometric mean antibody concentrations were adjusted for group-matching variable.|One month after dose 2, at Month 3|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available at Month 3.|||mIU/mL||95% Confidence Interval|Geometric Mean
2566383|NCT02581345|Secondary|Median Time to Seroconversion|Time to seroconversion (in days) was defined as the time to the observation of the first confirmed positive ADA response. Participants with confirmed positive ADA response at baseline (Week 0 predose) were excluded.|Up to Week 52|Safety Analysis Set. Only those participants who had a postdose seroconversion time were analyzed.|||days||Full Range|Median
2566384|NCT02581345|Secondary|Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 52 (Completion/Termination Visit)|The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.|Week 52|Safety Analysis Set|||Participants|||Count of Participants
2566385|NCT02581345|Secondary|Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 25|The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.|Week 25|Safety Analysis Set|||Participants|||Count of Participants
2566386|NCT02581345|Secondary|Immunogenicity: Number of Participants With ADA and nADA by Titer at Week 16|The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.|Week 16|Safety Analysis Set|||Participants|||Count of Participants
2566387|NCT02581345|Secondary|Immunogenicity: Number of Participants With ADA and nADA by Titer at Baseline|The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose); if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. In confirmed positive samples, an assay was used to determine the relative titer of the ADA; a subsequent neutralizing antibodies assay was used to determine the presence of neutralizing antibodies.|Baseline (Week 0)|Safety Analysis Set|||Participants|||Count of Participants
2566408|NCT02581345|Secondary|Percent Change From Baseline in PASI Score at Week 16|The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Percent change from Baseline was calculated as: (post-Baseline value - Baseline value) / (Baseline value) * 100.|Baseline; Week 16|PP Analysis Set. Only those participants contributing data at Week 16 were analyzed.|||percent change||Standard Deviation|Mean
2566388|NCT02581345|Secondary|Immunogenicity: Number of Participants With ADA at Week 52 (Completion/Termination Visit)|The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose; if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. The same convention applied for the neutralizing assay results.|Week 52|Safety Analysis Set|||Participants|||Count of Participants
2566389|NCT02581345|Secondary|Immunogenicity: Number of Participants With ADA at Week 25|The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose; if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. The same convention applied for the neutralizing assay results.|Week 25|Safety Analysis Set|||Participants|||Count of Participants
2566390|NCT02581345|Secondary|Immunogenicity: Number of Participants With ADA at Week 16|The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose; if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. The same convention applied for the neutralizing assay results.|Week 16|Safety Analysis Set|||Participants|||Count of Participants
2566391|NCT02581345|Secondary|Immunogenicity: Number of Participants With Anti-Drug Antibodies (ADA) at Baseline|The M923 confirmation assay was evaluated only if the EU Humira confirmation assay was negative. Overall Result: a participant was considered to be positive if a confirmed positive result was observed at any assay (including predose; if a participant had either a negative result in the screening assay or a positive result at screening followed by a negative result in all confirmation tiers, the overall result was negative. Overall Status: a participant was considered to have developed ADA or neutralizing ADAs if a confirmed positive result was observed at any time during the treatment period inclusive of the predose results; the designation of negative required either a negative screening assay or a negative confirmation result at each sampling time. The same convention applied for the neutralizing assay results.|Baseline (Week 0)|Safety Analysis Set|||Participants|||Count of Participants
2566392|NCT02581345|Secondary|Pharmacokinetics: Serum Concentrations by Treatment|Serum samples were collected at Baseline (Week 0, perdose), approximately 1 week (peak) after IP administration (Weeks 8 and 16), and 2 weeks after dose administration as a trough sample collected prior to the next dose administration (Weeks 17, 21, 25, 29, 37, 41).|Baseline (Week 0), Week 8, 16, 17, 21, 25, 29, 37, and 41|Pharmacokinetic (PK) Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 measured concentration at a scheduled PK time point after start of dosing. Only participants with evaluable data were analyzed.|||nanograms per milliter (ng/mL)||Standard Deviation|Mean
2566393|NCT02581345|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|TEAEs are adverse events that occurred during or after study drug administration. For more details on adverse events please refer the safety section.|Up to Week 52|Safety Analysis Set|||Participants|||Count of Participants
2566394|NCT02581345|Secondary|Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 48 (Completion/Termination Visit)|Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.|Week 48|Safety Analysis Set|||Participants|||Count of Participants
2566395|NCT02581345|Secondary|Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Week 16|Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.|Week 16|Safety Analysis Set|||Participants|||Count of Participants
2566396|NCT02581345|Secondary|Number of Participants With Clinically Significant Abnormalities in Electrocardiogram Parameters at Baseline|Clinically significant abnormalities were classified as such by the Investigator and reported as adverse events.|Baseline|Safety Analysis Set|||Participants|||Count of Participants
2566397|NCT02581345|Secondary|Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 48 (Completion/Termination Visit)|Laboratory results included hematology [Red Blood Cell Count, Hemoglobin, Hematocrit, Platelet count, Mean cell volume, White blood cell count (total leucocytes), Neutrophils absolute, Neutrophils, Lymphocytes absolute, Lymphocytes, Monocytes absolute, Monocytes, Eosinophils absolute, and Eosinophils], chemistry (Aspartate transaminase, Alanine transaminase, Alkaline Phosphatase, Gamma glutamyl transferase, Total bilirubin, Creatine kinase, C-reactive protein, Cholesterol, Triglycerides, Total protein, Sodium, Potassium, Chloride, Urea, Creatinine, Albumin, Phosphate, Glucose, and Uric acid) and urinalysis [pH and Specific Gravity] parameters. Clinically meaningful changes were classified as such by the Investigator and reported as adverse events.|Week 48|Safety Analysis Set|||Participants|||Count of Participants
2566409|NCT02581345|Secondary|Absolute PASI Score at Week 52 (Follow-Up Visit)|The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score.|Week 52|PP Analysis Set. Only those participants contributing data at Week 52 were analyzed.|||units on a scale||Standard Deviation|Mean
2566398|NCT02581345|Secondary|Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Week 16|Laboratory results included hematology [Hemoglobin, Hematocrit, Platelet count, Mean cell volume, White blood cell count (total leucocytes), Neutrophils absolute, Neutrophils, Lymphocytes absolute, Lymphocytes, Monocytes, Eosinophils absolute, and Eosinophils], chemistry (Aspartate transaminase, Alanine transaminase, Gamma glutamyl transferase, Creatine kinase, C-reactive protein, Cholesterol, Triglycerides, Total protein, Potassium, Urea, Creatinine, Phosphate, Glucose, and Uric acid) and urinalysis [Specific Gravity] parameters. Laboratory results of a few hematology (Red Blood Cell Count and Monocytes absolute), chemistry (Alkaline Phosphatase, Total bilirubin, Sodium, Chloride, and Albumin), and urinalysis (pH) parameters were not assessed at Baseline and Week 16. Clinically meaningful changes were classified as such by the Investigator and reported as adverse events.|Week 16|Safety Analysis Set|||Participants|||Count of Participants
2566399|NCT02581345|Secondary|Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters at Baseline|Laboratory results included hematology [Hemoglobin, Hematocrit, Platelet count, Mean cell volume, White blood cell count (total leucocytes), Neutrophils absolute, Neutrophils, Lymphocytes absolute, Lymphocytes, Monocytes, Eosinophils absolute, and Eosinophils], chemistry (Aspartate transaminase, Alanine transaminase, Gamma glutamyl transferase, Creatine kinase, C-reactive protein, Cholesterol, Triglycerides, Total protein, Potassium, Urea, Creatinine, Phosphate, Glucose, and Uric acid) and urinalysis [Specific Gravity] parameters. Laboratory results of a few hematology (Red Blood Cell Count and Monocytes absolute), chemistry (Alkaline Phosphatase, Total bilirubin, Sodium, Chloride, and Albumin), and urinalysis (pH) parameters were not assessed at Baseline and Week 16. Clinically meaningful changes were classified as such by the Investigator and reported as adverse events.|Baseline|Safety Analysis Set|||Participants|||Count of Participants
2566400|NCT02581345|Secondary|Number of Participants With Clinically Meaningful Changes in Vital Signs|Vital signs included body temperature, respiratory rate, pulse rate, systolic and diastolic blood pressure, and weight. Clinically meaningful changes were classified as such by the Investigator and reported as adverse events.|Up to Week 52|Safety Analysis Set|||Participants|||Count of Participants
2566401|NCT02581345|Secondary|Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 48 (Completion/Termination Visit)|"The EQ-5D-5L health score was measured on a Visual Analog Scale (VAS) anchored by 0 = worst health you can imagine and 100 = best health you can imagine."|Week 48|PP Analysis Set. Only those participants contributing data at Week 48 were analyzed.|||units on a scale||Standard Deviation|Mean
2566402|NCT02581345|Secondary|Health-Related Quality of Life During Treatment: EQ-5D-5L at Week 16|"The EQ-5D-5L health score was measured on a Visual Analog Scale (VAS) anchored by 0 = worst health you can imagine and 100 = best health you can imagine."|Week 16|PP Analysis Set. Only those participants contributing data at Week 16 were analyzed.|||units on a scale||Standard Deviation|Mean
2566403|NCT02581345|Secondary|Health-Related Quality of Life During Treatment: EuroQoL 5-Dimension Health Status Questionnaire (EQ-5D-5L) at Baseline|"The EQ-5D-5L health score was measured on a Visual Analog Scale (VAS) anchored by 0 = worst health you can imagine and 100 = best health you can imagine. Baseline was defined as the last scheduled observation prior to dosing, typically Day 1, predose."|Baseline|Analysis was performed using PP Analysis Set including participants with evaluable data for part 1 and part 2 of the study.|||units on a scale||Standard Deviation|Mean
2566404|NCT02581345|Secondary|Health-Related Quality of Life During Treatment: DLQI Score at Week 48 (Completion/Termination Visit)|The DLQI score was calculated by summing the individual scores of each question at a given time point, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is impaired. For the analysis of responses, the participant's results were assessed on a scoring scale on which 3 = very much or yes (applicable to question 7 only), 2 = a lot, 1 = a little, 0 = not at all or not relevant. Interpretation of DLQI scoring can be taken as 0 - 1 = no effect at all on participant's life, 2 - 5 = small effect on participant's life, 6 - 10 = moderate effect on participant's life, 11 - 20 = very large effect on participant's life, and 21 - 30 = extremely large effect on participant's life.|Week 48|PP Analysis Set. Only those participants contributing data at Week 48 were analyzed.|||units on a scale||Standard Deviation|Mean
2566405|NCT02581345|Secondary|Health-Related Quality of Life During Treatment: DLQI Score at Week 16|The DLQI score was calculated by summing the individual scores of each question at a given time point, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is impaired. For the analysis of responses, the participant's results were assessed on a scoring scale on which 3 = very much or yes (applicable to question 7 only), 2 = a lot, 1 = a little, 0 = not at all or not relevant. Interpretation of DLQI scoring can be taken as 0 - 1 = no effect at all on participant's life, 2 - 5 = small effect on participant's life, 6 - 10 = moderate effect on participant's life, 11 - 20 = very large effect on participant's life, and 21 - 30 = extremely large effect on participant's life.|Week 16|PP Analysis Set. Only those participants contributing data at Week 16 were analyzed.|||units on a scale||Standard Deviation|Mean
2566406|NCT02581345|Secondary|Health-Related Quality of Life During Treatment: Dermatology Life Quality Index (DLQI) Score at Baseline|The DLQI score was calculated by summing the individual scores of each question at a given time point, resulting in a maximum score of 30 and a minimum score of 0. The higher the score, the more quality of life is impaired. For the analysis of responses, the participant's results were assessed on a scoring scale on which 3 = very much or yes (applicable to question 7 only), 2 = a lot, 1 = a little, 0 = not at all or not relevant. Interpretation of DLQI scoring can be taken as 0 - 1 = no effect at all on participant's life, 2 - 5 = small effect on participant's life, 6 - 10 = moderate effect on participant's life, 11 - 20 = very large effect on participant's life, and 21 - 30 = extremely large effect on participant's life.|Baseline|Analysis was performed using PP Analysis Set including participants with evaluable data for part 1 and part 2 of the study.|||units on a scale||Standard Deviation|Mean
2566407|NCT02581345|Secondary|Percent Change From Baseline in PASI Score at Week 52 (Follow-Up Visit)|The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Percent change from Baseline was calculated as: (post-Baseline value - Baseline value) / (Baseline value) * 100.|Baseline; Week 52|PP Analysis Set. Only those participants contributing data at Week 52 were analyzed.|||percent change||Standard Deviation|Mean
2566410|NCT02581345|Secondary|Absolute PASI Score at Week 16|The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score.|Week 16|PP Analysis Set. Only those participants contributing data at Week 16 were analyzed.|||units on a scale||Standard Deviation|Mean
2566411|NCT02581345|Secondary|Absolute PASI Score at Baseline|The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score.|Baseline|Analysis was performed using PP Analysis Set including participants with evaluable data for part 1 and part 2 of the study are included in the analyses.|||units on a scale||Standard Deviation|Mean
2566412|NCT02581345|Secondary|Number of Participants Achieving PASI 90 Response at Week 52 (Follow-Up Visit)|The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 90 are defined as having an improvement (reduction) of at least 90% compared to Baseline.|Baseline; Week 52|PP Analysis Set. Only those participants contributing data at Week 52 were analyzed.|||Participants|||Count of Participants
2566413|NCT02581345|Secondary|Number of Participants Achieving PASI 90 Response at Week 16|The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 90 are defined as having an improvement (reduction) of at least 90% compared to Baseline.|Baseline; Week 16|PP Analysis Set|||Participants|||Count of Participants
2566414|NCT02581345|Secondary|Number of Participants Achieving PASI 75 Response at Week 52 (Follow-Up Visit)|The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 75 are defined as having an improvement (reduction) of at least 75% compared to Baseline.|Baseline; Week 52|PP Analysis Set. Only those participants contributing data at Week 52 were analyzed.|||Participants|||Count of Participants
2566415|NCT02581345|Secondary|Number of Participants Achieving PASI 50 Response at Week 52 (Follow-Up Visit)|The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 50 are defined as having an improvement (reduction) of at least 50% compared to Baseline.|Baseline; Week 52|PP Analysis Set. Only those participants contributing data at Week 52 were analyzed.|||Participants|||Count of Participants
2566416|NCT02581345|Secondary|Number of Participants Achieving PASI 50 Response at Week 16|The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 50 are defined as having an improvement (reduction) of at least 50% compared to Baseline.|Baseline; Week 16|PP Analysis Set|||Participants|||Count of Participants
2566417|NCT02581345|Secondary|Percentage of Participants With a Response of Clear or Almost Clear on the Static Physician Global Assessment (sPGA) at Week 16|The sPGA response rate was defined as the percentage of participants who had achieved a clear or almost clear response on the 6-point sPGA scale. The sPGA was the physician's determination of the participant's psoriasis lesions overall at a given time point. Overall lesions were categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis was assessed at a given time point on a 6-point scale on which 0 = cleared, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe.|Week 16|PP Analysis Set|||percentage of participants||95% Confidence Interval|Number
2566418|NCT02581345|Primary|Percentage of Participants Who Achieved a 75% Reduction in Psoriasis Area and Severity Index (PASI) (PASI 75) Scores at Week 16|The PASI combines assessments of the extent of body surface involvement in 4 anatomical regions (head, arms, trunk, and legs) and the severity of scaling, redness, and thickness in each region, yielding an overall score of 0 for no disease to 72 for the most severe disease. Each of the body areas was scored by itself, and then the 4 scores were combined into the final PASI score. Participants achieving PASI 75 are defined as having an improvement (reduction) of at least 75% in the Week 16 PASI score compared to the score at Baseline.|Baseline; Week 16|Per Protocol (PP) Analysis Set: subgroup of the Intent-To-Treat (ITT) Analysis Set that included all participants who did not have any deviations from the protocol deemed significant enough for exclusion from the efficacy analysis and received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2566419|NCT02581202|Secondary|Number of Participants With Adverse Events|Adverse events were not recorded in a solicited manner as in an interventional trial, but were recorded by spontaneous reporting in line with the requirements described in European Medicines Agency (EMA) Guideline on Good Pharmacovigilance Practices (GVP) module VI and local pharmacovigilance practice of the Russian Federation.|up to Week 48||||Participants|||Count of Participants
2566420|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 48: Triglycerides||Baseline, Week 48|Participants with measurements at given time point.|||mmol/L||Standard Deviation|Mean
2566421|NCT02581202|Secondary|Absolute Values and Change From Baseline in Metabolic Parameters at Week 24: Triglycerides||Baseline, Week 24|Participants with measurements at given time point.|||mmol/L||Standard Deviation|Mean
2566444|NCT02581202|Secondary|Number of Participants Who Developed Resistance to Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Protease Inhibitors (PIs)||Week 48|Participants with HIV-1 RNA viral load detected levels of ≥ 50 copies/mL up to Week 24.|||Participants|||Count of Participants
2566445|NCT02581202|Secondary|Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 48||Baseline, Week 48|Participants with valid measurements at given time point.|||cells/mm^3||Standard Deviation|Mean
2566446|NCT02581202|Secondary|Absolute Values and Change From Baseline in CD4+ T-cell Counts (Cells/mm^3) at Week 24||Baseline, Week 24|Participants with valid measurements at given time point.|||cells/mm^3||Standard Deviation|Mean
2566447|NCT02581202|Secondary|Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 48||Baseline, Week 48|Participants with valid measurements at given time point.|||percentage of lymphocytes that are CD4+||Standard Deviation|Mean
2566448|NCT02581202|Secondary|Absolute Values and Change From Baseline in CD4+ T-cell Counts (%) at Week 24||Baseline, Week 24|Participants with valid measurements at given time point.|||percentage of lymphocytes that are CD4+||Standard Deviation|Mean
2566449|NCT02581202|Secondary|Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Base-10 Logarithm Transformed Data)||Baseline, Week 48|Participants with data on HIV-1 RNA viral load at given time point.|||log10 copies/mL||Standard Deviation|Mean
2566450|NCT02581202|Secondary|Absolute Values and Change From Baseline in HIV-1- RNA Viral Load at Week 48 (Untransformed Data)|Statistics for absolute HIV-1 RNA viral load, where all participants with undetectable HIV-1-RNA viral load data were included into calculations with half of the lower indication limit (50/2 copies/mL, or 25.00 copies/mL).|Baseline, Week 48|Participants with data on HIV-1 RNA viral load at given time point.|||copies/mL||Standard Deviation|Mean
2566451|NCT02581202|Secondary|Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Base-10 Logarithm Transformed Data)||Baseline, Week 24|Participants with data on HIV-1 RNA viral load at given time point.|||log10 copies/mL||Standard Deviation|Mean
2566452|NCT02581202|Secondary|Absolute Values and Change From Baseline (BL) in HIV-1- RNA Viral Load at Week 24 (Untransformed Data)||Baseline, Week 24|Participants with data on HIV-1 RNA viral load at given time point.|||copies/mL||Standard Deviation|Mean
2566453|NCT02581202|Secondary|Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 24||Week 24|Participants with an assessment at given time point.|||percentage of participants||95% Confidence Interval|Number
2566454|NCT02581202|Primary|Percentage of Participants on Dual Therapy (LPV/r + 3TC) With Undetectable HIV-1 RNA Level at Week 48||Week 48|Participants with an assessment at given time point.|||percentage of participants||95% Confidence Interval|Number
2566455|NCT02581189|Secondary|Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria|The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented.|12 weeks after the last actual dose of study drug|Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants|||Number
2566456|NCT02581189|Secondary|Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria|Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure.|12 weeks after the last actual dose of study drug|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants|||Number
2566457|NCT02581189|Secondary|Percentage of Participants Meeting Relapse Criteria|Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment.|12 weeks after the last actual dose of study drug|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants|||Number
2566458|NCT02581189|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL).|12 weeks after the last actual dose of study drug|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants|||Number
2566459|NCT02581189|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment.|Up to 24 weeks|Core population (those meeting inclusion criteria and treated according to the standard of care and w/in local label guidelines for specific disease characteristics [cirrhotic status, genotype]) who had at least 1 undetectable or unquantifiable, on-treatment HCV RNA measurement and at least 1 on-treatment or end of treatment measurement thereafter|||percentage of participants||95% Confidence Interval|Number
2566460|NCT02581189|Secondary|Percentage of Participants With Relapse|Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL.|Up to 48 weeks after the last actual dose of study drug|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants||95% Confidence Interval|Number
2567017|NCT02573012|Secondary|Percentage of Visits With RA Flares||Randomization to 24 weeks||||Percentage of visits with flares|||Number
2566461|NCT02581189|Secondary|Percentage of Participants With Virologic Response at End of Treatment (EoT)|Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment.|Up to 24 weeks|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants||95% Confidence Interval|Number
2566462|NCT02581189|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|"SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria:~evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN~an HCV RNA value ≥50 IU/mL at the last measurement post-baseline~HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure"|12 weeks after the last actual dose of study drug|Core population (CP) and core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) are defined in the outcome measure description|||percentage of participants||95% Confidence Interval|Number
2566463|NCT02581163|Secondary|Percentage of Participants With Missing Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) Data and/or Nonresponders Who Did Not Meet Specific SVR12 Nonresponder Criteria|The number of participants with missing SVR12 data or SVR12 nonresponder participants who did not meet criteria for on-treatment virologic failure, relapse, premature treatment discontinuation, and who did not have an Insufficient virological response reported was documented.|12 weeks after the last actual dose of study drug|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants|||Number
2566464|NCT02581163|Secondary|Percentage of Participants Meeting Premature Study Drug Discontinuation Criteria|Premature study drug discontinuation was defined as participants who prematurely discontinued study drug with no on-treatment virologic failure.|12 weeks after the last actual dose of study drug|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants|||Number
2566465|NCT02581163|Secondary|Percentage of Participants Meeting Relapse Criteria|Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA greater than or equal to 50 IU/mL post-treatment.|12 weeks after the last actual dose of study drug|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants|||Number
2566466|NCT02581163|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as breakthrough (at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) less than 50 IU/mL followed by HCV RNA greater than or equal to 50 IU/mL during treatment) or failure to suppress (each measured on-treatment HCV RNA value greater than or equal to 50 IU/mL).|12 weeks after the last actual dose of study drug|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants|||Number
2566467|NCT02581163|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as at least 1 documented hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL followed by HCV RNA level greater than or equal to 50 IU/mL during treatment.|Up to 24 weeks|Core population (those meeting inclusion criteria and treated according to the standard of care and w/in local label guidelines for specific disease characteristics [cirrhotic status, genotype]) who had at least 1 undetectable or unquantifiable, on-treatment HCV RNA measurement and at least 1 on-treatment or end of treatment measurement thereafter|||percentage of participants|||Number
2566468|NCT02581163|Secondary|Percentage of Participants With Relapse|Relapse was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment followed by HCV RNA level greater than or equal to 50 IU/mL.|Up to 48 weeks after the last actual dose of study drug|Participants meeting inclusion criteria, treated according to standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype), with virologic response at end of treatment (EOT), completing Tx with ≥ 1 HCV RNA measurement ≥ 70 days post Tx or were a Tx failure between EOT and day 70|||percentage of participants||95% Confidence Interval|Number
2566469|NCT02581163|Secondary|Percentage of Participants With Virologic Response at End of Treatment (EoT)|Virologic response was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL at the end of treatment.|Up to 24 weeks|Core population: Participants meeting all inclusion criteria and who were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype)|||percentage of participants||95% Confidence Interval|Number
2566495|NCT02580799|Secondary|Percentage of Participants With Pathological Grade|Modified Bloom-Richardson Grade scoring system was used which considers the amount of glandular/tubular differentiation, nuclear features and the mitotic activity of tumor cells. Tubular, Nuclear and Mitosis scoring pattern was discussed in outcome 11, each score was added to give a final total score ranging from 3-9. Tumors with 3, 4 or 5 points are classified as being of low malignancy or Grade I, those with 6 or 7 points of intermediate malignancy or Grade II, and those with 8 or 9 points of high malignancy or Grade III.|Up to 70 days|FAS population.|||percentage of participants|||Number
2566608|NCT02578745|Secondary|Number of Participants With Any COMPONENT of SSI or Composite Wound Complication|Proportion of Participants with Surgical site infection; Proportion of Participants with wound separation; Proportion of participants with hematoma; Proportion of participants with seroma.|30 days||||Participants|||Count of Participants
2566470|NCT02581163|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|"SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than 50 IU/mL 12 weeks after the last actual dose of study drug. The core population (CP) consisted of participants who met all inclusion criteria and were adequately treated according to the standard of care and within local label recommendations for their specific disease characteristics (cirrhotic status, genotype). The core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) was defined as all CP participants who fulfilled one of the following criteria:~evaluable HCV RNA data ≥70 days after the last actual dose of the ABBVIE REGIMEN~an HCV RNA value ≥50 IU/mL at the last measurement post-baseline~HCV RNA <50 IU/mL at the last measurement post-baseline, but no HCV RNA measurement ≥70 days after the last actual dose of the ABBVIE REGIMEN due to reasons related to safety (e.g. dropped out due to AE) or virologic failure"|12 weeks after the last actual dose of study drug|Core population (CP) and core population with sufficient follow-up data 12 weeks after the last actual dose of study drug (CPSFU12) are defined in the outcome measure description.|||percentage of participants||95% Confidence Interval|Number
2566471|NCT02581137|Other Pre-specified|Microbiome Signatures Correlated With Treatment Response|Will first evaluate changes in alpha diversity among matched pairs using non-parametric analogous Wilcoxon rank-sum test (Mann-Whitney test). To test for significant differences in beta diversity (e.g. if pretreatment and post-treatment samples cluster in principle coordinates analysis space), PERMANOVA will be used.|Baseline to up to 14 weeks|||||||
2566472|NCT02581137|Other Pre-specified|Change in Saliva Microbiome Analyzed Using Flow Cytometry|This will characterize changes in the saliva microbiome before and after metformin intervention, including both the absolute microbial load and taxonomic composition. Will first evaluate changes in alpha diversity among matched pairs using non-parametric analogous Wilcoxon rank-sum test (Mann-Whitney test). To test for significant differences in beta diversity (e.g. if pretreatment and post-treatment samples cluster in principle coordinates analysis space), permutational multivariate analysis of variance (PERMANOVA) will be used.|Baseline to up to 14 weeks|||||||
2566473|NCT02581137|Secondary|Change in Serum and Saliva Inflammatory and Angiogenic Cytokines|Nonparametric methods, e.g. signed rank test, will be performed to evaluate each of the changes in tissue, serum, and saliva markers.|Baseline to up to 14 weeks|||||||
2566474|NCT02581137|Secondary|Change in Serum Metabolic Markers|Nonparametric methods, e.g. signed rank test, will be performed to evaluate each of the changes in tissue, serum, and saliva markers.|Baseline to up to 14 weeks|||||||
2566475|NCT02581137|Secondary|Change in Measurements of Metformin Hydrochloride Concentrations in Serum and Saliva|Nonparametric methods, e.g. signed rank test, will be performed to evaluate each of the changes in tissue, serum, and saliva markers.|Baseline to up to 14 weeks|||||||
2566476|NCT02581137|Secondary|Impact of Genomic Alterations on the Biological and Biochemical Consequences and Clinical Response to Metformin Hydrochloride|Nonparametric methods, e.g. signed rank test, will be performed to evaluate each of the changes in tissue, serum, and saliva markers. A univariate logistic regression model with the clinical response as the outcome variable will be fitted to explore if any genomic alterations are associated with the clinical response to metformin hydrochloride.|Up to 14 weeks|||||||
2566477|NCT02581137|Secondary|Changes in Frequent Dysregulated Molecular Mechanisms and OCT Expression|Nonparametric methods, e.g. signed rank test, will be performed to evaluate each of the changes in tissue, serum, and saliva markers. A univariate logistic regression model with the clinical response as the outcome variable will be fitted to explore if any of the expression of frequent dysregulated mechanisms and OCT3 level are associated with the clinical response to metformin hydrochloride.|Baseline to up to 14 weeks|||||||
2566478|NCT02581137|Secondary|Changes in Cell Proliferation and Its Molecular Targets|Nonparametric methods, e.g. signed rank test, will be performed to evaluate each of the changes in tissue, serum, and saliva markers.|Baseline to up to 14 weeks|||||||
2566479|NCT02581137|Secondary|Histologic Response to Metformin Intervention|"Number of participants with complete and partial histologic response to metformin intervention.~Criteria for complete and partial histologic response are:~Complete Response (CR): Complete reversal of dysplasia or hyperplasia to normal epithelium in the target lesion.~Partial Response (PR): Improvement of the degree of dysplasia or hyperplasia in the target lesion."|Baseline to up to 14 weeks||||Participants|||Count of Participants
2566480|NCT02581137|Primary|Clinical Response to Metformin Intervention|"Number of participants with complete and partial clinical response to metformin intervention.~Criteria for complete and partial clinical response are:~Complete Response (CR): Disappearance of all evidence of lesion(s). Partial Response (PR): Greater than or equal to 50% reduction in the sum of the products of diameters of lesion(s) measurable at baseline. Non-measurable lesion(s) may not increase greater than or equal to 25% in size and no new lesion may appear."|Baseline to up to 14 weeks||||Participants|||Count of Participants
2566481|NCT02581111|Secondary|Acute Change in Oxygenation (P/F Ratio)|Change in PaO2:FiO2 ratio from ABG at 4-6 hours after randomization compared to baseline prior to randomization|Baseline and ABG at 4-6 hours after intervention||||mm Hg||Inter-Quartile Range|Median
2566482|NCT02581111|Secondary|Number of Participants Who Had Lungs Transplanted|Whether one or both lungs were transplanted from this organ donor (dichotomized)|At time of organ recovery (within 72 hours)||||Participants|||Count of Participants
2566483|NCT02581111|Primary|Change in Oxygenation (P/F Ratio) From Baseline to Final Pre-recovery Arterial Blood Gas (ABG)|Change in ratio of partial pressure of oxygen in arterial blood (PaO2) to fraction of inspired oxygen (FiO2) from final ABG performed before organ recovery compared to baseline ABG|Baseline and at time of organ recovery, within 72 hours||||mm Hg||Inter-Quartile Range|Median
2566484|NCT02580799|Primary|Kappa Coefficient as a Measure of Agreement Between Abroad and Trial Sites (A, B, C, D and E) Concerning the IHC Test of Breast Tissue Samples|Inter-laboratory variation between the sites was assessed using Kappa test, K values to be interpreted as follows: a) <0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|Up to 70 days|FAS population.|||kappa coefficient|||Number
2566633|NCT02578706|Primary|Change in sCD14 From Baseline to Week 24|Soluble CD14 (sCD14) levels in blood. sCD14 is a nonspecific maker of monocyte activation.|baseline and 24 weeks||||pg/mL||Standard Deviation|Mean
2566485|NCT02580799|Primary|Percentage of Participants With IHC Evaluation Between Abroad and Trial Sites (A, B, C, D and E)|IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have HER2 and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|"FAS population. n included the number of participants evaluable for the specified category."|||percentage of participants|||Number
2566486|NCT02580799|Primary|Kappa Coefficient as a Measure of Agreement Between Sites C, D and E Concerning the IHC Test of Breast Tissue Samples|Inter-laboratory variation between the sites was assessed using Kappa test, K values to be interpreted as follows: a) <0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.|||kappa coefficient|||Number
2566487|NCT02580799|Primary|Percentage of Participants With IHC Evaluation Between Site C and Others (Sites D and E)|IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have HER2 and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|"FAS population. Here “number of participants analyzed” included evaluable for the outcome measure and n included the number of participants evaluable for the specified category."|||percentage of participants|||Number
2566488|NCT02580799|Secondary|Percentage of Participants With Different IHC Results|"The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it's called HER2 negative. If the score is 2+, it's called borderline. A score of 3+ is called HER2 positive. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells."|Up to 70 days|FAS population.|||percentage of participants|Participants||Number
2566489|NCT02580799|Secondary|Percentage of Participants With HER2 Test Form Based on Primary Antibody|The primary antibodies included; Biocabe EP 10454, Cerb B2 (SP3 clone), Her2 Neu (SP3) Cell marque, Neomarkers (thermo) cerb B2-Ab-17 and Thermo SP3.|Up to 70 days|FAS population.|||percentage of participants|Participants||Number
2566490|NCT02580799|Secondary|Percentage of Participants With HER2 Test Form Based on Antigen Retrieval|Fixation of tissue samples cross-link proteins and masks antigenic sites; antigen retrieval process was performed before IHC staining in order to reverse the masking of antigenic sites. Antigen retrieval process was performed in this study using the following solutions: 1 hour Cell Conditioning 1 (CC1), 30 minutes (min) CC1 mild, 64 min CC1, CC1 Ethylenediaminetetraacetic acid (EDTA) standard, and Cell Conditioning 2 (CC2) 30 min.|Up to 70 days|FAS population.|||percentage of participants|Participants||Number
2566491|NCT02580799|Secondary|Percentage of Participants With HER2 Test Form Based on Different Automated Slide Stainers|Different slide stainers like Ventana, Ventana Benchmark 4XT, Ventana Benchmark Ultra and Ventana Benchmark XT were used to report HER2 test results on data registration forms (120 forms from trial sites [24 from each site] and 30 from the reference site).|Up to 70 days|FAS population.|||percentage of participants|Participants||Number
2566492|NCT02580799|Secondary|Percentage of Participants With HER2 Test Form Based on Country|Reference site was considered as Abroad and the tests were performed in a laboratory in Amsterdam, Netherlands. A total of 150 data registration forms (120 forms from trial sites [24 from each site] and 30 from the reference site) were collected.|Up to 70 days|FAS population.|||percentage of participants|Participants||Number
2566493|NCT02580799|Secondary|Percentage of Participants With Specified Density of Hormone Receptors|The specific density of hormone receptors was examined by the amount of uptake of estrogen and progesterone hormones when analyzed using IHC staining procedure. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.|||percentage of participants|||Number
2566494|NCT02580799|Secondary|Percentage of Participants With Different Hormone Receptors|Presence of hormone receptors was examined by the amount of uptake of estrogen and progesterone hormones when analyzed using IHC staining procedure.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.|||percentage of participants|||Number
2566634|NCT02578680|Other Pre-specified|Progression-Free Survival (PFS) as Assessed by Investigator Immune-related RECIST (irRECIST) Response Criteria||Up to 24 months||2020-04-30|04/2020||||
2566496|NCT02580799|Secondary|Percentage of Participants With Pathological Score|Modified Bloom-Richardson Grade scoring system was used which considers the amount of glandular/tubular differentiation, nuclear features and the mitotic activity of tumor cells. Tubular score (TS) 1: >75 percent (%) of tumor area forming tubular structures, TS 2: 10% to 75% of tumor area forming tubular structures, TS 3: <10% of tumor area forming tubular structures. Nuclear score (NS) 1: nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size, NS 2: cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape, NS 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms. Mitosis score (MS) 1: ≤7 mitoses per 10 high power fields, MS 2: 8-14 mitoses per 10 high power fields and MS 3: ≥15 mitoses per 10 high power fields.|Up to 70 days|FAS population.|||percentage of participants|||Number
2566497|NCT02580799|Secondary|Percentage of Participants With Initial Tumor Node Metastasis (TNM) Stage According to Council Decision|TNM system is based on size of primary tumor (T), amount of spread to lymph nodes (N) and presence of metastasis (M). T1: tumor ≤20 millimeters (mm), T2: tumor >20 mm to ≤50 mm, T3: >50 mm and TX: tumor cannot be assessed. N0: no lymph node metastasis, N1: metastasis to ipsilateral level I, II axillary lymph nodes, N2: N1 metastasis that is clinically fixed/matted or in clinically detected ipsilateral internal mammary nodes, N3: metastases in ipsilateral infraclavicular lymph nodes, with/without level I, II axillary node involvement, or in clinically detected ipsilateral internal mammary lymph nodes and clinically evident level I, II axillary lymph node metastasis; or metastasis in ipsilateral supraclavicular lymph nodes, NX: Regional lymph nodes cannot be assessed. M0: no clinical/radiographic evidence of distant metastasis, M1: distant detectable metastases as determined by clinical and radiographic means and/or histologically proven >0.2 mm, and MX: metastases cannot be assessed.|Up to 70 days|"FAS population. Here “number of participants analyzed” included evaluable for the outcome measure and n included the number of participants evaluable for the specified category."|||percentage of participants|||Number
2566498|NCT02580799|Secondary|Percentage of Participants With Diagnosis of Primary Tumor|Primary tumor diagnosis was classified into invasive ductal carcinoma, invasive ductal carcinoma + integrin linked kinase (ILK) antibody and mixed (invasive ductal + lobular) and reported.|Up to 70 days|FAS population.|||percentage of participants|||Number
2566499|NCT02580799|Primary|Kappa Coefficient as a Measure of Agreement Between Site B and Others (Sites C, D and E) Concerning the IHC Test of Breast Tissue Samples|Inter-laboratory variation between the sites was assessed using Kappa test, K values to be interpreted as follows: a) <0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.|||kappa coefficient|||Number
2566500|NCT02580799|Primary|Percentage of Participants With IHC Evaluation Between Sites B and Others (Sites C, D and E)|IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have HER2 and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|"FAS population. Here “number of participants analyzed” included evaluable for the outcome measure and n included the number of participants evaluable for the specified category."|||percentage of participants|||Number
2566501|NCT02580799|Primary|Kappa Coefficient (K) as a Measure of Agreement Between Site A and Others (Sites B, C, D and E) Concerning the IHC Test of Breast Tissue Samples|Inter-laboratory variation between the sites was assessed using Kappa test, K values were interpreted as follows: a) less than (<) 0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.|Up to 70 days|FAS population. Here “number of participants analyzed” included evaluable for the outcome measure.|||kappa coefficient|||Number
2566502|NCT02580799|Primary|Percentage of Participants With Immunohistochemical (IHC) Evaluation Between Site A and Others (Sites B, C, D and E)|IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have Human Epidermal Growth Receptor (HER2) and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.|Up to 70 days|"FAS population. Here “number of participants analyzed” included evaluable for the outcome measure and n included the number of participants evaluable for the specified category."|||percentage of participants|||Number
2566503|NCT02580591|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26|Change from baseline in Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.|Baseline to week 26|FAS observed cases excluding data after change in use of anti-hypertensives (OC-H)|||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2567018|NCT02573012|Secondary|Time to First RA Flare|The mean time of onset for the first RA flare since randomization.|Randomization to 24 weeks||||Weeks||Standard Deviation|Mean
2566504|NCT02580591|Secondary|Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26|Change from baseline in Total daily insulin dose (TDID) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.|Baseline to week 26|FAS (OC)|||Unit/kilogram (U/kg)||Standard Error|Least Squares Mean
2566505|NCT02580591|Secondary|Change From Baseline in Body Weight at Week 26|Change from baseline in body weight is presented With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.|Baseline to week 26|FAS (OC)|||Kilogram (kg)||Standard Error|Least Squares Mean
2566506|NCT02580591|Secondary|Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycemic Adverse Events (AEs) With Confirmed Plasma Glucose (PG)|Rate per patient-year of investigator-reported symptomatic hypoglycemic adverse events (AEs) with confirmed plasma glucose (PG) <54 milligram per deciliter (mg/dL) (<3.0 millimoles per litre (mmol/L)) and/or severe hypoglycemic AEs (i.e. all investigator-reported AEs that had confirmed PG <54 mg/dL [<3.0 mmol/L] with symptoms reported and all severe hypoglycemic events that were confirmed by adjudication) is presented for (i) From week 5 to 26 and (ii) From week 1 to 26. Least squares mean is actually an adjusted event rate. This is key secondary endpoints.|Week 5 to Week 26, Week 1 to Week 26|FAS (OC)|||Events per patient year||95% Confidence Interval|Least Squares Mean
2566507|NCT02580591|Primary|Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD))|Change from baseline in Glycated hemoglobin (HbA1c) for modified intention-to-treat population set (mITT) (observed case - all data [OC-AD]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.|Baseline to week 26|Modified intention-to-treat set (mITT) (observed case – all data [OC-AD]): Patients in the TS who had a baseline and at least 1 post-baseline HbA1c measurement.|||Percentage (%)||Standard Error|Least Squares Mean
2566508|NCT02580591|Primary|Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 for Full Analysis Set (FAS) (Observed Cases [OC])|Change from baseline in Glycated hemoglobin (HbA1c) for full analysis set (FAS) (observed cases [OC]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomized trial medication. Least squares mean is adjusted mean change from baseline.|Baseline to week 26|Full analysis set (FAS) (observed cases [OC]): Patients in the Treated Set (TS) who had a baseline and at least 1 on-treatment HbA1c measurement.|||Percentage (%)||Standard Error|Least Squares Mean
2566509|NCT02580357|Other Pre-specified|Tissue Thickness|Through four fixed points marked 5 and 7 mm from the gingival margin in the operated region, tissue thickness of palatine masticatory mucosa. One stent was made to standardize the points to be measured. The stent was positioned, and with a periodontal probe and the points were marked. Then the stent was removed and measurements were taken. For this, an endodontic spacer with a rubber cursor was put on the marked points for it to reach the palatine bone plate. Then the cursor was taken to the tissue carefully to not pressuring it. The distance between the spacer tip and the cursor was measured using a digital pachymeter and measured in millimeters (mm).|Before the procedure and 3 months after the procedure|||||||
2566510|NCT02580357|Secondary|Postoperative Discomfort|"After air jet application, patients were requested to score postoperative discomfort through on a visual analogue scale (VAS) of 10 centimeters, in which 0 meant no pain and 10 meant extreme pain. After this, a postoperative discomfort average for all groups was obtained."|7, 14, 45, and 60 days after surgical procedure||||units on a scale||Standard Deviation|Mean
2566511|NCT02580357|Primary|Change in the Remaining Wound Area (RWA)|For this, standardized photographs were taken (brightness, distance and angle). A scale was used as a reference to measure this area. These photographs were exported to image software ( Image J - NIH, Bethesda, USA) and remaining wound area was measured in square millimeters (mm²).|7,14, 45 and 60 post operative days||||Square millimeters|Photographs|Standard Deviation|Mean
2566512|NCT02580318|Primary|Percent Alcohol Concentration Measured by Breathalyzer||20 minutes|number of participants that completed breath alcohol content are reported.|||percent Breathalyzed alcohol content||Standard Deviation|Mean
2566513|NCT02580240|Secondary|All Cause Mortality|Death from any cause at 90 days after the onset of septic shock|90 days||||Participants|||Count of Participants
2566514|NCT02580240|Primary|28-day Mortality|Death from any cause at 28 days after the onset of septic shock|28 days||||Participants|||Count of Participants
2566515|NCT02580188|Other Pre-specified|Postoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)|Postoperative pain is controlled by IV patient controlled analgesia using fentanyl. If patient complain of severe pain (VNRS score of 7 or more), additional analgesics can be used according to the attending physician.|48hr after end of operation||||score on a scale||Inter-Quartile Range|Median
2566516|NCT02580188|Other Pre-specified|Postoperative Pain is Evaluated by Verbal Numerical Rating Scale (VNRS, 0 = no Pain, 10 = the Severest Pain Imaginable)|Postoperative pain is controlled by IV patient controlled analgesia using fentanyl. If patient complain of severe pain (VNRS score of 7 or more), additional analgesics can be used according to the attending physician.|24hr after end of operation||||score on a scale||Inter-Quartile Range|Median
2566517|NCT02580188|Primary|Number of Participants With Increased Intra-abdominal Pressure (IAP) Alarm as > 15 mmHg|"Intra-abdominal pressure was maintained at 12 mmHg during pneumoperitoneum(using the carbon dioxide gas insufflation) and the pressure alarm for IAP was set at < 15 mmHg.~Intra-abdominal pressure is measured in a separate machine connected to a carbon dioxide gas injection line."|intraoperative, an averrage of 3 hour||||Participants|||Count of Participants
2566573|NCT02579759|Secondary|Number of Subjects With at Least One TEAE|"Safety selection was to include all randomized patients that have received at least one dose of study treatment.~Safety and tolerability of PXT3003 were compared to placebo on the incidence of treatment-emergent adverse events (TEAEs); they were evaluated by type/nature, severity/intensity, seriousness, and relationship to study drug."|The period between the patient signing the informed consent and 30 days after the end of study (i.e. completion/early discontinuation/last contact as recorded on the 'Study Completion on Early Termination' form up to 15 months)|FAS selection|||participants|||Number
2566518|NCT02580058|Secondary|Change From Baseline in EQ-VAS Score at End of Treatment|The EuroQol- 5 Dimensions- 5 Levels (EQ-5D-5L) questionnaire consists of the EQ-5D-5L descriptive system and a visual analogue scale (the EuroQol-visual analogue scale [EQ-VAS]). The respondent's self-rated health is assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS.|Baseline and end of treatment/withdrawal visit|The analysis is based on the FAS. The FAS included all participants who were randomized. 'Number Analyzed' represents number of participants in the FAS with an assessment at the visit or with at least a baseline and post-baseline assessment at visit.|||scores on a scale||Standard Deviation|Mean
2566519|NCT02580058|Secondary|Time to Deterioration in Abdominal/GI Symptom Subscale of EORTC QLQ-OV28|The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer 28 (EORTC QLQ-OV28) is a 28 item instrument with 7 functional domain subscales. Time to deterioration was defined as the time from randomization to the first time the participant's score showed a 15-point or higher increase in the score of the abdominal/GI symptom subscale of the EORTC QLQ-OV28.|From Day 1 of Cycle 1 to prior to end of treatment/withdrawal visit, based on cutoff date: 19 September 2018.|The analysis is based on the FAS. The FAS included all participants who were randomized.|||months||95% Confidence Interval|Median
2566520|NCT02580058|Secondary|Number of Participants With Improved, Stable and Deterioration Based on 10-Point Change for EORTC QLQ-C30 Global QoL|The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) is a 30 question survey and includes 5 functional domain subscales, global health status/quality of life, disease/treatment related symptoms, and the perceived financial impact of disease. Higher scores are reflective of a greater presence of symptoms.|Day 1 of Cycle 1, Day 1 of each subsequent cycle, end of treatment/withdrawal visit and the 30, 60 and 90 days safety follow up visits, based on cutoff date: 19 September 2018.|The analysis is based on the FAS. The FAS included all participants who were randomized. 'Number Analyzed' in represents number of participants in the FAS with a score at baseline and post-baseline.|||Participants|||Count of Participants
2566521|NCT02580058|Secondary|Number of Participants With CD8 Expression for PFS (Based on BICR Assessment) and for OS|Tumor infiltrating CD8 positive (CD8+) T lymphocytes was assessed by immunohistochemistry. Participants were considered positive for CD8 T cells if their baseline tissue sample demonstrated presence of >=1% CD8+ cells across the area of the tumor.|Biomarkers are measured only at screening.|The biomarker analysis set included participants who had at least 1 screening biomarker assessment. 'Number of Participants Analyzed' is based on number of participants in the biomarker analysis set within each treatment group with reported CD8 status.|||Participants|||Count of Participants
2566522|NCT02580058|Secondary|Number of Participants With PD-L1 Expression for PFS (Based on BICR Assessment) and for OS|PD-L1 expression was assessed by immunohistochemistry. Participants were considered positive for PD-L1 if their baseline tissue sample demonstrated PD-L1 expression on >=1% of tumor cells or >=5% of immune cells.|Biomarkers are measured only at screening.|The biomarker analysis set included participants who had at least 1 screening biomarker assessment. 'Number of Participants Analyzed' is based on number of participants in the biomarker analysis set within each treatment group with reported PD-L1 status.|||Participants|||Count of Participants
2566523|NCT02580058|Secondary|Number of Participants With % Left Ventricular Ejection Fraction (LVEF) Decrease From Baseline|LVEF decrease was summarized by multiple-gated acquisition (MUGA)/ echocardiogram (ECHO) parameter. Participants with a LVEF% >=10 points and >= 15 points decrease from baseline during the on-treatment period were summarized.|Screening, Cycle 3 Day 1 (repeated every 2 cycles) to the end of treatment/withdrawal visit, based on cutoff date: 19 September 2018.|'Number of Participants Analyzed' is based on number of participants in the safety analysis set with a baseline and a post-baseline assessment within each treatment group.|||Participants|||Count of Participants
2566524|NCT02580058|Secondary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Categorical summarization ECG criteria were as follows: 1) QT interval, QTcB, QTcF and QTcP: increase from baseline >30 ms or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR): change from baseline >=20 bpm and absolute value <=50 bpm or >=120 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS: >= 120 ms.|From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.|'Number of Participants Analyzed' is based on the safety analysis set, which included all participants who received at least 1 dose of study treatment. 'Number Analyzed' included the number of participants in the safety analysis set who had a at least 1 post-baseline ECG assessment performed.|||Participants|||Count of Participants
2566525|NCT02580058|Secondary|Change From Baseline in Vital Signs - Pulse Rate|Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized.|From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.|'Number of Participants Analyzed' is based on the safety analysis set, which included all participants who received at least 1 dose of study treatment. 'Number Analyzed' included the number of participants in the safety analysis set with at least a baseline and post-baseline assessment at the visit.|||bpm||Standard Deviation|Mean
2566526|NCT02580058|Secondary|Change From Baseline in Vital Signs - Blood Pressure|Vital signs included blood pressure and pulse rate. Changes from baseline in sitting diastolic blood pressure (DBP) and systolic blood pressure (SBP) were summarized.|From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.|'Number of Participants Analyzed' is based on the safety analysis set, which included all participants who received at least 1 dose of study treatment. 'Number Analyzed' included the number of participants in the safety analysis set with at least a baseline and post-baseline assessment at the visit.|||mm Hg||Standard Deviation|Mean
2566547|NCT02579876|Secondary|Eosinophilic Esophagitis Symptom Score (Intent to Treat Population)|"Symptoms of Eosinophilic Esophagitis range from abdominal pain, gastroesophageal reflux, vomiting, and difficult swallowing. Investigator assessment of the subject's symptoms was completed on a 4-point Likert scale for 3 separate symptoms (vomiting, abdominal pain and dysphagia).~Investigator assessment of the subject's symptoms was completed on a 4-point Likert scale for 3 separate symptoms (vomiting, abdominal pain and dysphagia). (0-none, 1-mild, 2-moderate, 3-severe, ). Total score is reported with a range of 0 to 9. A lower score is better."|Total Symptom Score at End of DB Phase, Month 11||||units on a scale||Standard Deviation|Mean
2567019|NCT02573012|Secondary|Percentage of Participants With >=1 Flare|Percentage of participants with >=1 flare|24 weeks||||Percentage of Participants|||Number
2566527|NCT02580058|Secondary|Number of Participants With Laboratory Abnormalities|The number of participants with following laboratory abnormalities meeting any of the Grades 1 to 4 classified according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading version 4.03 were summarized: hematology (anemia, lymphocyte count decreased, neutrophil count decreased; and platelet count decreased) and chemistry laboratory tests (creatinine increased; serum amylase increased and lipase increased).|From screening to the end of treatment/withdrawal visit, up to 2.7 years, based on cutoff date: 19 September 2018.|'Number of Participants Analyzed' is based on the safety analysis set, which included all participants who received at least 1 dose of study treatment. 'Number Analyzed' included the number of participants in the safety analysis set who can be evaluated for CTCAE criteria for each parameter in each treatment group.|||Participants|||Count of Participants
2566528|NCT02580058|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An adverse event (AE) is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; progression of the malignancy under study. Treatment emergent AEs are those events with onset dates occurring during the on-treatment period for the first time, or if the worsening of an event is during the on-treatment period.|From Cycle 1 Day 1 to 90 days after the last dose of study treatment (up to 2.7 years by primary completion date of 19 September 2018).|Analysis is based on the safety analysis set. The safety analysis set included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2566529|NCT02580058|Secondary|DC Rate Based on Investigator Assessment|Percentage of participants achieving DC based on investigator assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or SD according to the RECIST version 1.1.|Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.|The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
2566530|NCT02580058|Secondary|Disease Control (DC) Rate Based on BICR Assessment|Percentage of participants achieving DC based on BICR assessment is presented in this endpoint. DC is a best overall response of CR (disappearance of all target lesions), PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions), non-complete response/non-progressive disease or stable disease (SD) according to the RECIST version 1.1.|Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.|The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
2566531|NCT02580058|Secondary|DR Based on Investigator Assessment|DR is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR [disappearance of all target lesions] or PR [>=30% decrease under the baseline of the sum of diameters of all target measurable lesions]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.|Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.|The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized. Number analyzed are participants with confirmed CR or PR in the FAS within each treatment group.|||months||95% Confidence Interval|Median
2566532|NCT02580058|Secondary|Duration of Response (DR) Based on BICR Assessment|DR is defined, for participants with an OR per RECIST version 1.1, as the time from the first documentation of objective tumor response (CR [disappearance of all target lesions] or PR [>=30% decrease under the baseline of the sum of diameters of all target measurable lesions]) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.|Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.|The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized. Number analyzed are participants with confirmed CR or PR in the FAS within each treatment group.|||months||95% Confidence Interval|Median
2566533|NCT02580058|Secondary|PFS Based on Investigator Assessment According to RECIST Version 1.1|PFS is defined as the time from date of randomization to the date of the first documentation of PD or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method.|From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.|The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized.|||month||95% Confidence Interval|Median
2566534|NCT02580058|Secondary|ORR Based on Investigator Assessment|Percentage of participants achieved OR based on investigator assessment is presented for this endpoint. OR is defined as a CR (disappearance of all target lesions) or PR (>=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. The ORR on each randomized treatment arm were estimated by dividing the number of participants with OR (CR or PR) by number of participants randomized to the respective treatment arm.|Tumor assessments as assessed by investigator were conducted at every 8 weeks from screening until documented disease progression, up to 30 months; based on cutoff date: 19 September 2018.|The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
2566571|NCT02579759|Secondary|Incidence of SAEs|Safety and tolerability of PXT3003 were compared to placebo on the incidence of serious adverse events (SAEs).|The period between the patient signing the informed consent and 30 days after the end of study (i.e. completion/early discontinuation/last contact as recorded on the 'Study Completion on Early Termination' form up to 15 months).|FAS selection|||participants|||Number
2566535|NCT02580058|Secondary|Objective Response Rate (ORR) Based on BICR Assessment|Percentage of participants achieved objective response (OR) based on BICR assessment is presented for this endpoint. OR is defined as a complete response (CR, disappearance of all target lesions) or partial response (PR, >=30% decrease under the baseline of the sum of diameters of all target measurable lesions) according to the RECIST (version 1.1) recorded from randomization until disease progression or death due to any cause. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met and before the first documentation of disease progression. Only tumor assessments performed on or before the start date of any further anti-cancer therapies are considered in the assessment of best overall response.|Tumor assessments as assessed by BICR were conducted at every 8 weeks from screening until documented disease progression (approximately up to 30 months); based on cutoff date: 19 September 2018.|The secondary efficacy endpoint was analyzed in FAS. The FAS included all participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
2566536|NCT02580058|Primary|Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|PFS is defined as the time from date of randomization to the date of the first documentation of progression of disease (PD) or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method. PFS based on BICR assessment was evaluated for this endpoint.|From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.|The primary analyses of PFS based on BICR assessment were performed using FAS. The FAS included all participants who were randomized.|||months||95% Confidence Interval|Median
2566537|NCT02580058|Primary|Overall Survival (OS)|OS is defined as the time from the date of randomization to the date of death due to any cause. OS time was summarized by treatment arm using the Kaplan-Meier method.|From randomization until the date of first documented progression or date of deaths from any cause, whichever came first, assessed up to 30 months (based on cutoff date: 19 September 2018).|The primary analyses of OS were performed based on the Full Analysis Set (FAS). The FAS included all participants who were randomized.|||months||95% Confidence Interval|Median
2566538|NCT02579928|Primary|Montgomery-Asberg Depression Rating Scale Score 1 Day After Infusion|"A change in depressive symptoms (measured by Montgomery-Asberg Depression Rating Scale, revised (MADRS) score) on 1 day after infusion, for the cohort of subjects enrolled in the MDD arm of this trial.~Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.~Usual cutoff points are:~0 to 6 - normal /symptom absent. 7 to 19 - mild depression. 20 to 34 - moderate depression. >34 - severe depression."|1 day after the infusion|A total of 17 patients were randomized to receive either Ketamine or Midazolam in the first infusion, one participant in withdrew from the trail after the first infusion because of improvement in her depressive symptoms and did not receive the second infusion.|||units on a scale||95% Confidence Interval|Mean
2566539|NCT02579915|Secondary|Patient Health Questionnaire-9||6-8 weeks after first treatment session|||||||
2566540|NCT02579915|Secondary|7-item Generalized Anxiety Disorder Scale||6-8 weeks after first treatment session|||||||
2566541|NCT02579915|Primary|Hamilton Anxiety Rating Scale|Number of participants who achieved a 20% reduction in their interview-administered Hamilton Anxiety Rating Scale Total Score.|6-8 weeks after first treatment session|We only analyzed participants who completed their post-treatment assessment, which is required to calculate their % reduction in symptoms.|||Participants|||Count of Participants
2566542|NCT02579876|Secondary|Pediatric Eosinophil Esophagitis Symptom Score (PP Population)|Pediatric Eosinophilic Esophagitis Symptom Score at end of DB phase using the validated Pediatric Eosinophilic Esophagitis Symptom Score (PEESS).The PEESS® is a 20 question survey asking patient symptom intensity and frequency on a 5 point scale (0 to 4) for each question for the preceding month. Therefore, the total score can range from 0 to 80. The total score is reported and lower score is better.|Month 11, End of Double Blind Placebo Control||||score on a scale||Standard Deviation|Mean
2566543|NCT02579876|Secondary|Endoscopy Score (Per Protocol Patients)|"Upper endoscopies with biopsies (2 each of proximal and distal, plus any inflamed areas) will be completed before and after each treatment period. Each endoscopy will be scored using a validated standardized measure which examines 4 major esophageal features (rings, furrows, exudates and edema) and the presence of minor features of narrow caliber esophagus, feline esophagus, stricture and crepe paper esophagus. Each feature is graded: 0-none, 1 mild, 2-moderate, 3-severe. The scores including both major and minor criteria are summed.~Total score is presented and lower score is better. The range is from 0-12"|Month 11 (end of double blind phase)||||score on a scale||Standard Deviation|Mean
2566544|NCT02579876|Secondary|Pediatric Eosinophilic Esophagitis Symptom Score (ITT)|Measure of Pediatric Eosinophilic Esophagitis symptom Score (PEESS) at the end of DB phase for the Intent to Treat Population The PEESS® is a 20 question survey asking patient symptom intensity and frequency on a 5 point scale (0 to 4) for each question for the preceding month. Therefore, the total score can range from 0 to 80. The total score is reported and lower score is better|Month 11, end of Double Blind Phase||||units on a scale||Standard Deviation|Mean
2566545|NCT02579876|Secondary|Eosinophils Per HPF at End of Double Bind Protocol (Per Protocol) Patients|Maximum Eosinophils/HPF after milk reintroduction at the end of double bind phase|End of DB Phase, at 11 months||||Eos/hpf||Standard Deviation|Mean
2566546|NCT02579876|Secondary|Esophageal Endoscopy Score (ITT)|"Upper endoscopies with biopsies (2 each of proximal and distal, plus any inflamed areas) will be completed before and after each treatment period. Each endoscopy will be scored using a validated standardized measure which examines 4 major esophageal features (rings, furrows, exudates and edema) and the presence of minor features of narrow caliber esophagus, feline esophagus, stricture and crepe paper esophagus. Each feature is graded: 0-none, 1 mild, 2-moderate, 3-severe. The scores are summed including both minor and major criteria.~Total score is presented and lower score is better. The range is from 0-12"|At end of DB phase, at 11 months||||score on a scale||Standard Deviation|Mean
2566572|NCT02579759|Secondary|Incidence of AE Leading to Withdrawal of Study Drug|Safety and tolerability of PXT3003 were compared to placebo on the incidence of TEAEs leading to withdrawal of study drug.|The period between the patient signing the informed consent and 30 days after the end of study (i.e. completion/early discontinuation/last contact as recorded on the 'Study Completion on Early Termination' form up to 15 months)|FAS selection|||participants|||Number
2566548|NCT02579876|Primary|Change in Eosinophils/High Power Field at End of Double-blind (DB) (Per Protocol Patients)|"Esophageal biopsy samples will be obtained prior to randomization and after completion of treatment. Intraepithelial eosinophils will be counted in all high powered fields (HPFs) using light microscopy. A HPF will be counted only if at least half of the field is occupied by tissue. The maximum eosinophil count per HPF will be reported for each esophageal biopsy site (at each of 2 levels).~The maximum eosinophil count for each patient will be calculated from either level. For the final outcome, mean from each individual patients maximum eosinophil count/hpf along with standard deviation will be calculated."|Month 11(end of double blind phase)||||Eosinophils (Eos)/high power field||Standard Deviation|Mean
2566549|NCT02579876|Primary|Change in Maximum Esophageal Eosinophil Count From Baseline to End of Double-blind Treatment. (Intent to Treat Population)|"Esophageal biopsy samples will be obtained prior to randomization and after completion of treatment. Intraepithelial eosinophils will be counted in all high powered fields (HPFs) using light microscopy. A HPF will be counted only if at least half of the field is occupied by tissue. The maximum eosinophil count per HPF will be reported for each esophageal biopsy site (at each of 2 levels).~The maximum eosinophil count for each patient will be calculated from either level. For the final outcome, mean from each individual patients maximum eosinophil count/hpf along with standard deviation will be calculated."|From baseline to month 11 (end of double blind phase)||||Eosinophils (Eos)/high power field (HPF)||Standard Deviation|Mean
2566550|NCT02579863|Secondary|Number of Participants Discontinuing Study Treatment Due to an AE|An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.|Up to approximately 30 months|The analysis population consisted of all randomized participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2566551|NCT02579863|Secondary|Number of Participants Who Experienced One or More Adverse Events (AEs)|An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.|Up to approximately 30 months|The analysis population consisted of all randomized participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2566552|NCT02579863|Secondary|Second Progression Free Survival (PFS2)|PFS2 was defined as the time from randomization to subsequent disease progression after initiation of new anti-cancer therapy, or death from any cause, whichever occurred first, by investigator assessment. PFS was assessed by Clinical Adjudication Committee (CAC) blinded central review according to the IMWG response criteria based on the development of new bone lesions or soft tissue plasmacytomas or on a definite increase in the size of existing bone lesions or soft tissue plasmacytomas. PFS2 was not completed due to incomplete enrollment for a clinical hold.|Up to approximately 30 months|The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized. PFS2 was not completed due to incomplete enrollment for a clinical hold.||||||
2566553|NCT02579863|Secondary|Disease Control Rate (DCR) Evaluated According to the IMWG Response Criteria by CAC Blinded Central Review|Disease control rate was defined as the percentage of participants who achieved confirmed sCR, CR, VGPR, PR, or have demonstrated SD for at least 12 weeks prior to any evidence of progression. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours; SD = not meeting the criteria for CR, VGPR, PR, or PD; PD = development of new bone lesions or soft tissue plasmacytomas or on a definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Data cutoff date was July 9, 2018.|Up to approximately 30 months|The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2566554|NCT02579863|Secondary|Duration of Response (DOR) Evaluated According to IMWG Response Criteria by CAC Blinded Central Review|Response duration was defined as the time from first documented evidence of at least a partial response (sCR+CR+VGPR+PR]), until confirmed disease progression or death. DOR was calculated from product-limit (Kaplan-Meier) method for censored data. The data cutoff date was July 9, 2018. This is an event-driven (events of disease progression and death) outcome measure. At the time of data cut-off, there were an insufficient number of events from the censored data to be able to estimate certain parameters (e.g. medians). Full Range is the minimum and maximum of the observed duration of response.|Up to approximately 30 months|The analysis population included all randomized participants who demonstrated at least a partial response. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2566555|NCT02579863|Secondary|Overall Response Rate (ORR) Evaluated According to the IMWG Response Criteria by CAC Blinded Central Review|ORR was defined as the percentage of the participants in the analysis population who achieved at least a partial response (stringent complete response [sCR]+complete response [CR]+very good partial response [VGPR]+partial response [PR]) according to the IMWG. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. The data cutoff date was July 9, 2018.|Up to approximately 30 months|The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2566606|NCT02578745|Secondary|Number of Participants With Positive Wound Culture|Rate of positive wound culture in participants with SSI after cesarean.|30 days||||Participants|||Count of Participants
2566556|NCT02579863|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. The data cutoff date was July 9, 2018. This is an event-driven (events of death) outcome measure. At the time of data cut-off, there were an insufficient number of events from the censored data to be able to estimate certain parameters (e.g. medians).|Up to approximately 30 months|The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2566557|NCT02579863|Primary|Progression Free Survival (PFS) Assessed by Clinical Adjudication Committee (CAC) Blinded Central Review According to the International Myeloma Working Group (IMWG) Response Criteria|PFS was defined as the time from randomization to the first documented disease progression (events of new bone lesions, soft tissue plasmacytomas or an increase in existing lesions, or death due to any cause). The median PFS was calculated from the product-limit (Kaplan-Meier) method for censored data. The data cutoff date was July 9, 2018. Due to the smaller number of events, the tail of the estimated survival distribution was close to the median for both arms. The higher variability of the tail estimates resulted in observing the median estimate in the experimental arm but not in the standard of care arm even when number of events in 2 arms were similar. Additionally, since median of the experimental arm was in the tail of the estimated survival distribution, standard error of the survival estimates was missing before upper limit of the 95% confidence interval was reached, resulting in a missing upper limit of 95% confidence interval for the experimental arm.|Up to approximately 30 months|The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2566558|NCT02579772|Secondary|Change in Pulmonary Ventilation - Minute Ventilation (VE)|During cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)|end-exercise value (Day 4)||||liters/min||Standard Error|Mean
2566559|NCT02579772|Secondary|Change in Pulmonary Oxygen Uptake - Dynamics (Mean Response Time)|Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)|Day 4||||seconds||Standard Error|Mean
2566560|NCT02579772|Secondary|Change in Skeletal Muscle Vascular Function - Capillary Blood Flow Dynamics (Mean Response Time)|Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)|Day 4||||seconds||Standard Error|Mean
2566561|NCT02579772|Secondary|Change in Skeletal Muscle Deoxygenation - Dynamics (Mean Response Time)|Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)|Day 4||||seconds||Standard Error|Mean
2566562|NCT02579772|Secondary|Change in Central Cardiovascular Function - Cardiac Output|During cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)|end-exercise value (Day 4)||||liters/min||Standard Error|Mean
2566563|NCT02579772|Primary|Exercise Capacity - Time to Exhaustion|Cycling time to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)|end-exercise value (Day 4)||||seconds||Standard Error|Mean
2566564|NCT02579772|Primary|Plasma Redox Status - Circulating Glutathione|Fluorescent detection of plasma glutathione from samples collected during day 4 of each experimental arm (placebo vs. N-acetylcysteine)|pre-exercise value (day 4)||||micromolar||Standard Error|Mean
2566565|NCT02579759|Other Pre-specified|Number of Participants With ONLS Therapy Response 2|"ONLS Therapy Response 2 was defined as the number of participants with no deterioration (responders) on final ONLS Total Score.~A higher response rate indicates a better clinical condition."|From Baseline to Month 15|Completers selection|||Number of Participants|||Number
2566566|NCT02579759|Other Pre-specified|Number of Participants With ONLS Therapy Response 1|ONLS Therapy Response 1 was defined as the number of participants (responders) with an improvement on final ONLS Total Score of at least one point. A higher response rate indicate a better clinical condition.|From Baseline to Month 15|Completers selection|||Number of Participants|||Number
2566567|NCT02579759|Other Pre-specified|Plasma Concentrations of 6β-naltrexol at Trough and at 90 Min After Drug Intake|"Plasma concentration of PXT3003 components were measured at trough (prior to dose) and peak (90 minutes post dose).~The mean plasma values of the baseline correspond to half of the administered dose."|At Month 12 and Month 15|PP selection LLOQ = 50 pg/mL The placebo arm has not been described for this endpoint.|||pg/mL||Standard Deviation|Mean
2566568|NCT02579759|Other Pre-specified|Plasma Concentrations of Naltrexone at Trough and at 90 Min After Drug Intake|"Plasma concentration of PXT3003 components were measured at trough (prior to dose) and 90 minutes after drug intake.~The mean plasma values of the baseline correspond to half of the administered dose."|At Month 12 and month 15|PP selection LLOQ = 30 pg/mL The placebo arm has not been described for this endpoint.|||pg/mL||Standard Deviation|Mean
2566569|NCT02579759|Other Pre-specified|Plasma Concentrations of Baclofen at Trough and at 90 Min After Drug Intake|"Plasma concentration of PXT3003 components were measured at trough (prior to dose) and 90 minutes after drug intake.~The mean plasma values of the baseline correspond to half of the administered dose."|At Month 12 and Month 15|PP selection LLOQ = 30 pg/mL The placebo arm has not been described for this endpoint.|||pg/mL||Standard Deviation|Mean
2566570|NCT02579759|Other Pre-specified|Mean of the CMTNS-v2 Sensory Symptoms|"This outcome measure is the mean of the available CMTNS-v2 Sensory Symptoms values at month 12 and month 15.~The CMTNS-v2 is a specific scale designed to assess severity of impairment in CMT disease. It is a 36-point scale based on nine items to quantify impairment (sensory symptoms, pin sensibility, vibration and arm and leg strength), activity limitations (motor symptoms arms and legs) and electrophysiological function (amplitudes of ulnar CMAP and SNAP). The CMTNS-v2 goes from 0 (no impairment) to 36 (maximum impairment) whom each sub-items goes from 0 to 4.~The CMTNS-v2 Sensory Symptoms is the first item of the CMTNS-v2. It is a 4-point score: 0 (no impairment) to 4 (maximum impairment).~Lower CMTNS-v2 Sensory Symptoms values indicate a better clinical condition.~Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin)."|From Baseline to Month 15|mFAS selection|||Scores on the CMTNS-v2 Sensory Symptoms||Standard Deviation|Mean
2566607|NCT02578745|Secondary|Pain Score on a 0 to 10 on Likert Scale|Participant pain scores on postoperative day 2 on a 0 (minimum) to 10 (maximum) 0n Likert Scale, where 0 is no pain and 10 is the worse pain. Higher score means worse outcome|Postoperative days 2||||units on a scale||Inter-Quartile Range|Median
2566574|NCT02579759|Secondary|Mean of the Results at the Nine-Hole Peg Test (9-HPT)|"This outcome measure is the mean of the available 9-HPT values at month 12 and month 15.~The Nine-Hole Peg Test (9HPT) is a simple timed test of fine motor coordination of extremitied in the upper limbs. It measures the time needed by the patient to insert 9 pegs in nine holes and to remove them (normal required time 18 seconds).~Lower 9HPT values indicate a better clinical condition.~Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin)."|From Baseline to Month 15|mFAS selection|||Seconds (s)||Standard Deviation|Mean
2566575|NCT02579759|Secondary|Mean of the CMTNS-v2 Examination Score (CMTES-v2)|"This outcome measure is the mean of the available CMTNS-v2 Examination Score values at month 12 and month 15.~The CMTNS-v2 is a specific scale designed to assess severity of impairment in CMT disease. It is a 36-point scale based on nine items to quantify impairment (sensory symptoms, pin sensibility, vibration and arm and leg strength), activity limitations (motor symptoms arms and legs) and electrophysiological function (amplitudes of ulnar CMAP and SNAP). The CMTNS-v2 goes from 0 (no impairment) to 36 (maximum impairment) whom each sub-items goes from 0 to 4.~The CMTES-v2 is summed of item 1 to 7 of the CMTNS-v2 (limited to impairment items and excluding electrophysiological items). It is a 28-point score: 0 (no impairment) to 28 (maximum impairment).~Lower CMTES-v2 values indicate a better clinical condition.~Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin)."|From Baseline to Month 15|mFAS selection|||Scores on the CMTES-v2||Standard Deviation|Mean
2566576|NCT02579759|Secondary|Mean of the CMTNS-v2 Sensory Score|"This outcome measure is the mean of the available CMTNS-v2 Sensory Score values at month 12 and month 15.~The CMTNS-v2 is a specific scale designed to assess severity of impairment in CMT disease. It is a 36-point scale based on nine items to quantify impairment (sensory symptoms, pin sensibility, vibration and arm and leg strength), activity limitations (motor symptoms arms and legs) and electrophysiological function (amplitudes of ulnar CMAP and SNAP). The CMTNS-v2 goes from 0 (no impairment) to 36 (maximum impairment) whom each sub-items goes from 0 to 4.~The CMTNS-v2 Sensory score is summed of items 1+4+5 of CMTNS-v2 (Sensory symptoms, Pinprick sensibility and Vibration). It is a 12-point score: 0 (no impairment) to 12 (maximum impairment).~Lower CMTNS-v2 Sensory Score values indicate a better clinical condition.~Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin)."|From Baseline to Month 15|mFAS selection|||Scores on the CMTNS-v2 Sensory Score||Standard Deviation|Mean
2566577|NCT02579759|Secondary|Mean of Ten Meter Walking Test (10MWT)|"This outcome measure is the mean of the available 10MWT values at month 12 and month 15.~The 10MWT is a simple to administer, standardized, reliable and valid evaluation of functional exercise capacity and gait that has been used to evaluate neurologic disorders and CMT patients.~Lower Time to Walk 10 Meters values indicate a better clinical condition.~Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin)."|From Baseline to Month 15|mFAS selection|||Seconds (s)||Standard Deviation|Mean
2566578|NCT02579759|Primary|Overall Neuropathy Limitation Scale (ONLS) Total Score|"The primary efficacy variable used in the main analysis is the mean of the available ONLS values at month 12 and month 15.~The ONLS is a disability scale that was derived and improved from the Overall Disability Sum Score (ODSS) to measure limitations in the everyday activities of the upper limbs (rated on 5 points) and the lower limbs (rated on 7 points). The total score is a 12-point scale: 0 (no disability) to 12 (maximum disability). Lower values in the ONLS indicate a better clinical condition.~Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin)."|From Baseline to Month 15|mFAS selection|||Scores on the ONLS||Standard Deviation|Mean
2566579|NCT02579603|Secondary|Predose Plasma Concentrations at Steady State (Cpre,ss) of Pirfenidone|Predose plasma concentrations at steady state (Cpre,ss) of pirfenidone at Week 2 (Visit 4) and Week 4 (Visit 5)|Prior to intake of study medication on week 2 and week 4|PKS set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2566580|NCT02579603|Secondary|Predose Plasma Concentrations at Steady State (Cpre,ss) of Nintedanib at Baseline, Weeks 2 and 4|Predose plasma concentrations at steady state (Cpre,ss) of nintedanib at baseline (Visit 3), Week 2 (Visit 4) and Week 4 (Visit 5)|baseline, prior to intake of study medication on week 2 and week 4|Pharmacokinetic Set (PKS): This analysis set included all patients who had been treated with study medication and who provided evaluable data for at least 1 PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2566581|NCT02579603|Primary|Percentage of Patients With On-treatment Gastrointestinal (GI) AEs (SOC GI Disorders) From Baseline to Week 12|"Percentage of patients with on-treatment gastrointestinal (GI) Adverse events (AEs) (SOC GI disorders) from baseline to week 12.~On-treatment AEs were defined as AEs with an onset from the first dose of randomised treatment up to the last dose of randomised treatment (inclusive)."|Baseline to week 12|Treated set : The treated set (104 patients) consisted of all randomised patients who were dispensed study medication and were documented to have taken at least 1 dose of randomised investigational treatment.|||percentage of participants|||Number
2566582|NCT02579421|Primary|Change in Marijuana Use as Defined by the TLFB|Marijuana use as defined by the TLFB at the week 4 visit relative to the baseline visit.|5 weeks. Baseline to week 4|Some participant data was not included in the analysis because it was missing|||MJ use occasions per day||Standard Deviation|Mean
2566583|NCT02579135|Primary|3-item Self-report of Sexual Communication Intentions Over Next 3 Months|We assessed intentions to communicate about sex with items from the AIDS Risk Behavior Assessment. Three items captured the likelihood of communicating with a partner in the next 3 months about (1) sexual limits and boundaries, (2) STDs and pregnancy, and (3) condom use. Options ranged from 0% to 100% to indicate the likelihood of communicating with a partner. We averaged scores to create a composite (possible range 0-100); higher scores indicated greater likelihood of sexual communication (alpha = 0.84).|Immediate post-test at completion of intervention and 3-month follow-up||||units on a scale||Standard Deviation|Mean
2566584|NCT02579135|Primary|7-item Self-report of Sexual Communication Self-efficacy|"We used the validated Self-Efficacy for HIV Prevention Scale to assess communication self-efficacy. Seven items assessed confidence communicating about sexual topics (e.g., How sure are you that you could talk to your partner about safer sex?). Participants responded from 1 for couldn't do it to 4 for very sure. Scores were averaged with higher scores indicating greater confidence in communicating about sex (alpha = 0.82)."|Immediate post-test at completion of intervention and 3-month follow-up||||units on a scale||Standard Deviation|Mean
2566585|NCT02579135|Primary|6-item Self-report of Program Acceptability|Program acceptability was assessed through a questionnaire that was adapted from prior acceptability surveys. Specifically, six items were included to assess six aspects of acceptability: (i) an intent to return to the website, (ii) whether one would recommend the program to a friend, (iii) whether one would use information from the program in the future, (iv) how much one liked the program, (v) how much one learned from the program and (vi) how much one felt the program kept their attention. The first three questions were coded with dichotomous response options (yes/no—unsure), whereas the last three items used a four point Likert-type scale ranging from 1=not at all to 4=a lot. For analyses, these last 3 items were dichotomized into 1=a lot and 0=not a lot.|Immediate post-test at completion of intervention|Data on acceptability only analyzed among girls who completed the Project HEART intervention|||Participants|||Count of Participants
2566586|NCT02579057|Secondary|Urine Sodium|Total urinary sodium produced during the 6 hour urine collection|6-hour period||||mEq/L||Standard Deviation|Mean
2566587|NCT02579057|Secondary|Number of Participants With Side Effects|Cumulative total of pain, local skin reactions (including hematoma and induration) and electrolyte abnormalities.|Up to 6 hours||||Participants|||Count of Participants
2566588|NCT02579057|Secondary|Heart Failure Symptom Scoring/Symptom Improvement|Will evaluate if subjective heart failure symptoms improve over the period of diuresis. Measured by Kansas City Cardiomyopathy Questionnaire|6-hour period|Data was not collected on enough patients to accurately analyze this endpoint. No data analysis was performed for this outcome.||||||
2566589|NCT02579057|Primary|Urine Output|The volume of urine produced in milliliters over the 6 hours after drug delivery will be measured.|6-hour period||||mL||Standard Deviation|Mean
2566590|NCT02578992|Secondary|Visual Analog Scale of Sore Throat|"All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit.~Scale range: 0-10. 0 is considered to be a better outcome while 10 is a worse outcome."|after anesthesia emergence 30 minutest, at post-anesthesia care unit||||units on a scale||Full Range|Mean
2566591|NCT02578992|Secondary|Mean Arterial Pressure|compare the mean arterial pressure between two groups.|before and after intubation, up to 5 minutes||||mmHg||Standard Deviation|Mean
2566592|NCT02578992|Secondary|Modified Cormack-Lehane Grade|"The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.~Scale range (1, 2, 3, 4). Grade 1 is considered to be a better outcome while grade 4 is considered to be a worse outcome."|during intubation, after epiglottis was identified on the video monitor||||units on a scale||Full Range|Mean
2566593|NCT02578992|Primary|Intubation Time|the interval from the intubating stylet touched the mouth to capnogram shown, with all attempts, and was recorded by an independent observer with a stop watch.|from the intubating stylet touched the mouth to the capnogram shown, up to 30 seconds, and the sum of all attempts||||seconds||Inter-Quartile Range|Median
2566594|NCT02578940|Secondary|Safety of 18F Fluciclovine Injection in Patients Undergoing PET/CT.|Safety was assessed from data on the occurrence of adverse events (AEs) and changes in clinical laboratory tests, vital signs, injection-site status and physical examination findings from the time of administration of 18F fluciclovine injection throughout the study period.|1 month|Treatment-emergent Adverse Events|||Participants|||Count of Participants
2566595|NCT02578940|Secondary|PSA Threshold for Positive Lesion Detection by 18F Fluciclovine PET/CT in BCR|PSA levels in relation to scan positivity were analysed to determine the optimal PSA threshold for detecting recurrent prostate cancer by 18F fluciclovine PET/CT|1 month|Full Analysis Set|||percentage of Detection Rate||95% Confidence Interval|Number
2566596|NCT02578940|Secondary|Response Rate to Radical Salvage Therapy|To establish the proportion of patients who have a sustained response to radical salvage therapy.|7 months|Full Analysis Set|||Participants|||Count of Participants
2566597|NCT02578940|Primary|Impact on Patient Treatment /Management|The record of the revised management plan post fluciclovine (18F) PET/CT scan in comparison to the pre-scan intended management plan.|1 month|For the primary analysis population, of the 104 patients included in the EAS, 58 patients with a positive 18F fluciclovine scan and 46 patients with a negative 18F fluciclovine scan had a pre-18F fluciclovine PET/CT management plan.|||Participants|||Count of Participants
2566598|NCT02578862|Secondary|Number of Patients Treated With Post-operative Anti-emetics|patients receiving medication for post-operative nausea and/or vomiting|24 hours following surgery completion||||Participants|||Count of Participants
2566599|NCT02578862|Secondary|Post-anesthesia Care Unit Recovery Time|Hours spent in post-anesthesia care unit post-operatively|Immediately following surgery (postoperative day zero)||||hours||Inter-Quartile Range|Median
2566600|NCT02578862|Secondary|Surgical Time|Total time spent in surgery (hours)|At time of surgery||||hours||Inter-Quartile Range|Median
2566601|NCT02578862|Secondary|Intraoperative Blood Loss|Amount of blood loss (milliliters) during surgery|At time of surgery||||mL||Inter-Quartile Range|Median
2566602|NCT02578862|Secondary|Sinus-related Quality of Life|Sinonasal Outcomes Test (SNOT-22) (validated)- measures sinus symptoms. Minimum 0 Maximum 110. Higher scores indicate worse sinus symptoms.|3 months and 6 months||||units on a scale||Inter-Quartile Range|Median
2566603|NCT02578862|Primary|Intraoperative Visual Field Assessment|"Wormald Visualization Scale (validated)~Grade Assessment (0-10) -Higher scores indicate worsening visualization~0 No bleeding~1-2 points of ooze~3-4 points of ooze~5-6 points of ooze~7-8 points of ooze~9-10 points of ooze (sphenoid fills in 60 seconds)*~10 points of ooze, obscuring surface (sphenoid fills in 50 seconds)*~Mild bleeding/oozing from entire surgical surface with slow accumulation of blood in the post nasal space (sphenoid fills by 40 seconds)~Moderate bleeding from entire surgical surface with moderate accumulation of blood in the post nasal space at (sphenoid fills by 30 seconds)~Moderately severe bleeding with rapid accumulation of blood in the post nasal space (sphenoid fills by 20 seconds)~Severe bleeding with nasal cavity filling rapidly(sphenoid fills in10 seconds)"|Performed intraoperatively at the end of surgical case||||units on a scale||Inter-Quartile Range|Median
2566604|NCT02578745|Secondary|Number of Participants With Any Prophylactic Negative Pressure-related Adverse Events.|Rate of composite of adverse events potentially attributable to NPWT including skin blisters, erythema, wound bleeding.|30 days||||Participants|||Count of Participants
2566605|NCT02578745|Secondary|Number of Participants With Methicillin-resistant Staphylococcus Aureus.|Rate of methicillin-resistant Staphylococcus aureus in patients with SSI after cesarean.|30 days||||Participants|||Count of Participants
2566609|NCT02578745|Primary|Number of Participants With Composite Surgical Site Infection (SSI) or Other Wound Complication.|Superficial or deep SSIs or other wound complications (separation, hematoma, seroma) after cesarean. SSI will be defined according to the Centers for Disease Control (CDC) criteria as infections at the surgical site occurring within 30 days of cesarean delivery, and classified as superficial, deep, or organ/space occupying.|30 days||||Participants|||Count of Participants
2566610|NCT02578706|Secondary|Change in Cholesterol Uptake by Monocytes|substudy|baseline and 24 weeks|data not collected||||||
2566611|NCT02578706|Secondary|Change in Thrombus Formation (High Shear) From Baseline to 24 Weeks|substudy - Change in thrombus formation by Badimon chamber (high shear) from baseline to 24 weeks. Thrombus formation on a blood vessel measured by immunohistochemistry staining of tissue cross sections. The high shear chambers (inner lumen diameter 0.1 mm, Reynolds number 60, shear rate 1690 s- 1) mimic the rheologic conditions of a moderately stenosed coronary artery.|baseline and 24 weeks||||μ(2)/mm||Standard Deviation|Mean
2566612|NCT02578706|Secondary|Change in Thrombus Formation (Low Shear) From Baseline to 24 Weeks|substudy - Change in thrombus formation by Badimon chamber (low shear) from baseline to 24 weeks. Thrombus formation on a blood vessel measured by immunohistochemistry staining of tissue cross sections. μ(2)/mm is the area of thrombus. The low shear chamber (inner lumen diameter 0.2 mm, Reynolds number 30, shear rate 500 s- 1) simulates flow conditions of a normal coronary artery.|baseline and 24 weeks||||μ(2)/mm||Standard Deviation|Mean
2566613|NCT02578706|Secondary|Change in Alpha Angle From Baseline to 24 Weeks|Alpha angle is measured using thromboelastography, measured by a tangent to the clotting curve through the 2mm point|baseline and 24 weeks||||degree||Standard Deviation|Mean
2566614|NCT02578706|Secondary|Change in Maximum Clot Firmness (MCF) From Baseline to 24 Weeks|Maximum Clot Firmness (MCF) is measured using thromboelastography. maximum ampliture in mm|baseline and 24 weeks||||mm||Standard Deviation|Mean
2566615|NCT02578706|Secondary|Change in Clot Formation Time (CFT) From Baseline to 24 Weeks|Clot formation time is measured using thromboelastography. time from 2 to 20 mm amplitude in seconds.|baseline and 24 weeks||||seconds||Standard Deviation|Mean
2566616|NCT02578706|Secondary|Change in Coagulation Time (CT) From Baseline to 24 Weeks|Clot formation kinetics, or coagulation time, is measured using thromboelastography. time to 2mm amplitude in seconds.|baseline and 24 weeks||||seconds||Standard Deviation|Mean
2566617|NCT02578706|Secondary|Change in Monocyte Platelet Aggregates From Baseline to 24 Weeks|Change in % platelet monocyte aggregates from baseline to week 24|baseline and 24 weeks||||% platelet monocyte aggregates||Standard Deviation|Mean
2566618|NCT02578706|Secondary|Change in Platelet Aggregometry in Response to Arachidonic Acid 1500µM From Baseline to Week 24|Change in % platelet aggregation in response to stimulation by arachidonic acid 1500µM from baseline to week 24|baseline and 24 weeks||||% platelet aggregation||Standard Deviation|Mean
2566619|NCT02578706|Secondary|Change in Spontaneous Platelet Aggregometry From Baseline to Week 24|Change in spontaneous % platelet from baseline to week 24. Spontaneous platelet aggregation?|baseline and 24 weeks||||% platelet||Standard Deviation|Mean
2566620|NCT02578706|Secondary|Change in Platelet Aggregometry in Response to Epi 5µM From Baseline to Week 24|Change in % platelet aggregation in response to stimulation by light transmission aggregometry as measured by epinephrine 5µM from baseline to week 24|baseline and 24 weeks||||% platelet aggregation||Standard Deviation|Mean
2566621|NCT02578706|Secondary|Change in Platelet Aggregometry in Response to Collagen 2µg/mL From Baseline to Week 24|Change in % platelet aggregation in response to stimulation by Collagen 2µg/mL from baseline to week 24|baseline and 24 weeks||||% platelet aggregation||Standard Deviation|Mean
2566622|NCT02578706|Secondary|Change in Platelet Aggregometry in Response to ADP 20µM From Baseline to Week 24|Change in % platelet aggregation in response to stimulation by Adenosine Diphosphate (ADP) from baseline to week 24|baseline and 24 weeks||||% platelet aggregation||Standard Deviation|Mean
2566623|NCT02578706|Secondary|Change in sCD40L From Baseline to Week 24|Soluble CD40-ligand levels|baseline and 24 weeks||||pg/mL||Standard Deviation|Mean
2566624|NCT02578706|Secondary|Change in sTNFR II From Baseline to Week 24|Soluble tumor necrosis factor receptor (sTNFR) serum concentration|baseline and 24 weeks||||pg/ml||Standard Deviation|Mean
2566625|NCT02578706|Secondary|Change in sTNFR I From Baseline to Week 24|Soluble tumor necrosis factor receptor (sTNFR) serum concentration|baseline and 24 weeks||||pg/ml||Standard Deviation|Mean
2566626|NCT02578706|Secondary|Change in D-dimer From Baseline to Week 24|D-Dimer level looks at coagulation of blood. D-dimers are not normally present in blood except when coagulation has occurred.|Baseline and 24 weeks||||mcg/L||Standard Deviation|Mean
2566627|NCT02578706|Secondary|Change in IL-6 From Baseline to Week 24|Interleukin 6 gene encodes a cytokine that functions in inflammation and implicated in a variety of inflammatory-associated disease states.|baseline and 24 weeks||||pg/mL||Standard Deviation|Mean
2566628|NCT02578706|Secondary|Change in Monocyte Activation sCD163 From Baseline to Week 24|Soluble CD163 is a specific macrophage activation marker, associated with morphological disease grade. A high sCD163 indicates more disease.|baseline and 24 weeks||||10^3 cells/µl||Standard Deviation|Mean
2566629|NCT02578706|Secondary|Change in Non-classical Monocyte Subsets From Baseline to Week 24|The non-classical monocyte shows low level expression of CD14 and additional co-expression of the CD16 receptor (CD14+CD16++ monocyte).[|baseline and 24 weeks||||10^3 cells/µl||Standard Deviation|Mean
2566630|NCT02578706|Secondary|Change in Intermediate Monocyte Subsets From Baseline to Week 24.|The intermediate monocyte with high level expression of CD14 and low level expression of CD16 (CD14++CD16+ monocytes).|Baseline and 24 weeks||||10^3 cells/µl||Standard Deviation|Mean
2566631|NCT02578706|Secondary|Change in Classical Monocyte Subsets From Baseline to Week 24|The classical monocyte is characterized by high level expression of the CD14 cell surface receptor (CD14++ CD16− monocyte)|baseline and 24 weeks||||10^3 cells/µl||Standard Deviation|Mean
2566632|NCT02578706|Secondary|Number of Subjects With at Least One Grade 3 or Higher Sign/Symptom or Laboratory Abnormality|Safety as measured by a Summary of the number of subjects with at least one grade 3 or higher sign/symptom or laboratory abnormality. A grade 3 sign/symptom was defined as medically significant but not immediately life threatening.|24 weeks||||Participants|||Count of Participants
2566635|NCT02578680|Secondary|Number of Participants Who Discontinued Any Study Drug Due to an AE|The number of participants who discontinued any randomized study drug due to an AE is presented.|Through Database Cutoff Date of 08-Nov-2017 (Up to approximately 21 months)|The analysis population consisted of all randomized participants who received ≥1 dose of study drug.|||Participants|||Count of Participants
2566636|NCT02578680|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a study participant administered study drug and which does not necessarily have to have a causal relationship with this study drug. For participants who switched from the Control group to receiving pembro, AEs that occurred after the first dose of pembro are excluded from this interim analysis, but will be included in the final analysis. The number of participants who experienced an AE is presented.|Through Database Cutoff Date of 08-Nov-2017 (Up to approximately 21 months); Serious AEs: Up to 90 days after last dose of study treatment, Other AEs: Up to 30 days after last dose of study treatment|The analysis population consisted of all randomized participants who received ≥1 dose of study drug.|||Participants|||Count of Participants
2566637|NCT02578680|Secondary|Duration of Response (DOR) Per RECIST 1.1 as Assessed by Blinded Central Imaging|For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. DOR assessments were based on blinded central imaging review with confirmation. The DOR per RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented.|From time of first documented evidence of CR or PR through database cutoff date of 08-Nov-2017 (Up to approximately 21 months)|The analysis population consisted of all randomized participants who experienced a confirmed CR or confirmed PR.|||Months||Full Range|Median
2566638|NCT02578680|Secondary|Overall Response Rate (ORR) Per RECIST 1.1 as Assessed by Blinded Central Imaging|ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The percentage of participants who experienced a CR or PR is presented.|Through Database Cutoff Date of 08-Nov-2017 (Up to approximately 21 months)|The analysis population consisted of all randomized participants.|||Percentage of Participants||95% Confidence Interval|Number
2566639|NCT02578680|Primary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. The OS is presented.|Through Database Cutoff Date of 08-Nov-2017 (Up to approximately 21 months)|The analysis population consisted of all randomized participants.|||Months||95% Confidence Interval|Median
2566640|NCT02578680|Primary|Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging|PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 is presented.|Through Database Cutoff Date of 08-Nov-2017 (Up to approximately 21 months)|The analysis population consisted of all randomized participants.|||Months||95% Confidence Interval|Median
2566641|NCT02578316|Secondary|Objective Tumor Response|A response of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) was assigned by the investigator as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. CR was defined as disappearance of all target lesions. Any pathological lymph node had to be reduced in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. PD was defined as a 20% or greater increase in the sum of the longest diameter of measured lesions, taking as reference the smallest sum longest diameter recorded since treatment start or the appearance of one or more new lesions. CR or PR was confirmed no less than 4 weeks after first observation of the response. For SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 6 weeks. SD is defined as lasting at least 5 weeks.|Baseline to first date of documented CR, PR, SD, or PD, assessed up to 1 year|The Response Evaluable Population is the group of participants who received at least a partial dose of study treatment who had measureable disease per RECIST at baseline.|||Percentage of participants|||Number
2566642|NCT02578316|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Safety was assessed by monitoring and recording all AEs including all Common Terminology Criteria for Adverse Events (CTCAE) grades (for both increasing and decreasing severity) and SAEs; regular monitoring of hematology, blood chemistry, and urine values; results of physical examinations, regular measurement of vital sign measurements, and 12-lead electrocardiogram (ECG), as detailed in the Schedule of Visits and Procedures. The relationship of AEs to treatment was based on investigator judgment. Details of AEs and SAEs are provided in the reported adverse event section.|Date of first dose of study treatment till 30 days after the last dose, assessed up to 1 year|The Safety Analysis Set was the group of participants who received at least one partial dose of study drug and had at least one postdose safety assessment.|||Percentage of participants|||Number
2566643|NCT02578316|Primary|Percentage Recovery of 14^C- Lenvatinib Related Material in the Feces|Fecal samples were collected at specific time points, then analyzed for the amount of 14^C- lenvatinib related material. The percentage of the 14^C- lenvatinib dose excreted in feces (Aefeces%) was calculated from time of dosing to the last quantifiable measurement. If radioactivity levels were still present at the end of the Study Phase, sampling continued until each sample contained less than 1% of the total radioactive dose. Percentage recovery of 14^C- lenvatinib related material in the feces was summarized as the Geometric Mean (CV%) percent cumulative for all participants and expressed as percent of 14^C- lenvatinib.|Day 1 to Day 8|PK Analysis Set|||Percentage of 14^C-lenvatinib||Geometric Coefficient of Variation|Geometric Mean
2566644|NCT02578316|Primary|Percentage Recovery of 14^C- Lenvatinib Related Material in the Urine|Urine samples were collected at specific time points, then analyzed for the amount of 14^C- lenvatinib related material. The total radioactive dose of 14^C-lenvatinib excreted in urine (Aeurine%) was calculated from the time of dosing to the last quantifiable measurement. If radioactivity levels were still present at the end of the Study Phase, sampling continued until each sample contained less than 1% of the total radioactive dose. Percentage recovery of 14^C- lenvatinib related material in the urine was summarized as the Geometric Mean (CV%) percent cumulative for all participants and expressed as percent of 14^C- lenvatinib.|Pre-dose, post-dose at 0-6, 6-12, 12-18, 18-24, 24-30, 30-36, 36-42, 42-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours|PK Analysis Set|||Percentage of 14^C-lenvatinib||Geometric Coefficient of Variation|Geometric Mean
2566645|NCT02578316|Primary|Renal Clearance of Lenvatinib (CLr)|CLr was determined based on the interval amount and cumulative amount of the analyte excreted in the urine divided by its corresponding AUC over the same collection interval. Aeurine(0-t)/AUC(0-t), where t is the last measurable concentration, was calculated for lenvatinib only and was summarized as the Geometric Mean (CV%) for all participants and expressed in L/hr.|Pre-dose, post-dose at 0-6, 6-12, 12-18, 18-24, 24-30, 30-36, 36-42, 42-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours|PK Analysis Set|||L/hour||Geometric Coefficient of Variation|Geometric Mean
2566646|NCT02578316|Primary|Apparent Terminal Volume of Distribution in the Terminal Phase of Lenvatinib (Vz/F)|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. Vz/F for lenvatinib only was calculated as Dose/[(λz)·(AUC(0-inf))] and was summarized as the Geometric Mean (CV%) for all participants and expressed in liters (L).|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set|||L||Geometric Coefficient of Variation|Geometric Mean
2566647|NCT02578316|Primary|Apparent Clearance (CL/F) of Lenvatinib From Plasma|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. The CL/F for parent lenvatinib only was calculated as Dose/[AUC(0-inf)] and was summarized as the Geometric Mean (CV%) for all participants and expressed in L/hr.|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set|||L/hour||Geometric Coefficient of Variation|Geometric Mean
2566648|NCT02578316|Primary|Percentage of Area Under the Plasma Concentration Curve Extrapolated to Infinity (%AUC(Extra))|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. %AUC(extra) was calculated as [(AUC(0-inf) - AUC(0-t)/AUC(0-inf) ]*100 and was summarized as the Geometric Mean (CV%) for all participants and expressed in (ng·hr/mL).|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set|||Percent lenvatinib||Geometric Coefficient of Variation|Geometric Mean
2566649|NCT02578316|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC(0-inf))|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. The AUC(0-inf) was calculated as AUC(0-t) + Ct/λz where Ct is the last measurable concentration and was summarized as the Geometric Mean (CV%) for all participants and expressed in ng·hr/mL.|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
2566650|NCT02578316|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time t (AUC(0-t))|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. The AUC(0-t) was calculated by the combination of linear/log (from Tmax) trapezoidal rule where 't' is the time of last quantifiable plasma concentration following dosing. AUC(0-t) was summarized as the Geometric Mean (CV%) for all participants and expressed in nanograms·hour/milliliter (ng·hr/mL).|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
2566651|NCT02578316|Primary|Terminal Exponential Half-life (t1/2) of Radiolabeled 14^C-Lenvatinib and Non-Radiolabeled Lenvatinib in Plasma|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. The terminal phase t1/2 is the time required to divide the plasma concentration of study drug by two after reaching pseudo-equilibrium, and not the time required to eliminate half of the administered dose of study drug. The t1/2 during the apparent terminal disposition phase was calculated at 0.693/λz and was summarized as the Geometric Mean (CV%) for all participants and expressed as hours.|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set|||Hours||Geometric Coefficient of Variation|Geometric Mean
2566652|NCT02578316|Primary|Terminal Phase Rate Constant (λz) of Radiolabeled 14^C-Lenvatinib and Non-Radiolabeled Lenvatinib in Plasma|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. The terminal phase rate constant represents the rate at which study drug was eliminated from the body and was determined by log-linear regression of the plasma concentrations against time in the terminal phase and was summarized as the Geometric Mean (CV%) for all participants and expressed as 1/hours.|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set|||1/hour||Geometric Coefficient of Variation|Geometric Mean
2566714|NCT02577107|Secondary|Plasma VEGF Concentration at Baseline, Visit 2, 3, 4, 5, 6 After 1st Injection|Blood sample will be collected for systemic VEGF. VEGF will be measured by a blinded laboratory using ELISA kits. Baseline, Visit Visit 2, 3, 4, 5, 6 after 1st injection|Baseline, Visit 2, 3, 4, 5, 6|Per-protocol Set refers to all subjects who completed the study without any major deviation from the study protocol.|||pg/mL||Standard Deviation|Mean
2566653|NCT02578316|Primary|Time of Maximum Plasma Concentration (Tmax) of Radiolabeled 14^C-Lenvatinib and Non-Radiolabeled Lenvatinib|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. Individual blood/plasma concentration-time data were analyzed using 'non-compartmental' analysis. Tmax was determined from visual inspection of the individual blood/plasma concentration-time profile and was summarized as the Geometric Mean (CV%) for all participants and expressed as hours.|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|PK Analysis Set|||Hours||Geometric Coefficient of Variation|Geometric Mean
2566654|NCT02578316|Primary|Maximum Plasma Concentration (Cmax) of Radiolabeled 14^C-Lenvatinib and Non-Radiolabeled Lenvatinib|Blood samples were drawn at specific time points then analyzed for the amount of 14^C-lenvatinib and non-radiolabeled lenvatinib in the plasma. Individual blood/plasma concentration-time data were analyzed using 'non-compartmental' analysis. Cmax was determined from visual inspection of the individual blood/plasma concentration-time profile and was summarized as the Geometric Mean and percent coefficient of variation for the Geometric Mean (CV%) for all participants and expressed as nanograms/milliliter (ng/mL).|Day 1 (pre-dose, post-dose at 15 and 30 minutes, 1, 2, 4, 6, 8 and 12 hours), Day 2 (24 hours), Day 3 (48 hours), Day 4 (72 hours), Day 5 (96 hours), Day 6 (120 hours), Day 7 (144 hours) and Day 8 (168 hours)|The Pharmacokinetic (PK) Analysis Set is the group of participants who received the Study Phase dose of 14^C-lenvatinib and have any evaluable post 14^C- lenvatinib dose plasma and/or blood concentration data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2566655|NCT02578238|Primary|Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs/ADRs and Unexpected AEs/ADRs|An AE is defined as any untoward medical occurrence, which does not necessarily have a causal relationship with their treatment. If an AE meets any of the following criteria, it is considered a serious AE: results in death, is life-threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, is an important medical event requiring medical or surgical intervention to prevent serious outcome. An ADR label was used for an AE when causal relationship with a pharmaceutical drug could not be excluded.|From Day 0 (informed consent) to up to 70 days following the last administration of Humira®. The mean length of treatment was 52.81 (±45.58) weeks (calculated based on participants with available start date data [n=142]).||||percentage of participants||95% Confidence Interval|Number
2566656|NCT02578199|Secondary|Body Weight in Pounds|Body weight in pounds measured 6 months after starting treatment (3 month follow-up after active treatment ends).|6 months||||pounds||Standard Deviation|Mean
2566657|NCT02578199|Primary|Body Weight in Pounds|Body weight in pounds measured 3 months after starting treatment.|3 months|27 participants completed treatment, 28 participants completed the post treatment assessment (i.e., one participant who dropped from treatment completed the post treatment assessment).|||pounds||Standard Deviation|Mean
2566658|NCT02578186|Primary|Mean Latency to Persistent Sleep|Per Protocol population based on subjects who completed treatment crossover|4 weeks|Subjects with evaluable data for mean latency to persistent sleep for both treatment periods were included in the efficacy analysis provided they meet the other defined Per Protocol criteria. All data for each treatment and endpoint were averaged for all days in which the study medication was taken in a given treatment period.|||minutes||Standard Error|Mean
2566659|NCT02577991|Primary|Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score|Outcome measure used to measure the incidence and severity of postoperative trouble swallowing|Evaluated at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year|All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team|||percentage of patients|||Number
2566660|NCT02577991|Primary|Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op|Most commonly utilized pain scale; scored 0-10 with higher values indicating increased severity of pain experienced by the patient|Obtained at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year; analyzed for all time points through 6 months post op|All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team|||Score on a scale||Inter-Quartile Range|Median
2566661|NCT02577991|Primary|Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op|Outcome measure used to measure for neck pain that includes personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Summative scores for 10 questions (range 0-50) with each question scored 0-5 where higher scores for each question indicates greater extent of disability/difficulty for the associated activity. Reported as a mean percentage + standard deviation of difficulty/disability experienced by the patient.|Obtained at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year|All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team|||percentage of disability/difficulty||Standard Deviation|Mean
2566662|NCT02577991|Primary|Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op|Outcome measure used to measure the incidence and severity of postoperative trouble with hoarseness of voice; summative score of 10 questions (range 0-40) with each question scored 0-4 with higher scores indicating greater severity/frequency of disability or handicap reported by the patient. Reported as a percentage of patients in each group reporting an 'abnormal' VHI-10 score defined as a summative score >11|baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year.|All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team|||percentage of patients|||Number
2567181|NCT02570074|Secondary|UBT-time Curve (AUBT24)|For pathogens E. coli ATCC 25922, E. coli ATCC BAA-2323, K. pneumoniae ATCC 33495, K. pneumoniae ATCC 700603 and P. mirabilis ATCC 35659|24 hours at Day 1 and Day 5||||titers * hours||Standard Deviation|Mean
2566663|NCT02577991|Primary|Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op|Outcome measure used to measure the incidence and severity of postoperative trouble swallowing. Summative score of 10 questions (range 0-40) with each question scored 0-4 with higher scores indicating greater severity/frequency of difficulty or disability reported by the patient for the indicated activity; EAT-10 >3 = dysphagia & EAT-10 >15 = severe dysphagia|baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year.|All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team|||percentage|||Number
2566664|NCT02577978|Secondary|Get-up-and-Go Test|Used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down.|Between 6 months and 1 year post-operatively||||seconds||Standard Deviation|Mean
2566665|NCT02577978|Secondary|Assessing Knee Stability Using the KT-1000 Arthrometer (at 90 Degrees)|Used for grading the stability of the knee in various degrees of flexion according to section 4 of the International Knee Documentation Committee's Knee Ligament Standard Evaluation Form where normal (-1 to 2 mm); nearly normal (3 to 5 mm); abnormal (6 to 10 mm); severely abnormal (>10 mm)|1 year post-operatively||||millimeters||Standard Deviation|Mean
2566666|NCT02577978|Secondary|Assessing Knee Stability Using the KT-1000 Arthrometer (at 30 Degrees)|Used for grading the stability of the knee in various degrees of flexion according to section 4 of the International Knee Documentation Committee's Knee Ligament Standard Evaluation Form where normal (-1 to 2 mm); nearly normal (3 to 5 mm); abnormal (6 to 10 mm); severely abnormal (>10 mm)|1 year post-operatively||||millimeters||Standard Deviation|Mean
2566667|NCT02577978|Primary|Score for the Knee Society Score (KSS) Function Component at 1 Year Post-operatively|Physician completed Knee Society Score questionnaire used to measure a patient's functional ability before and after total knee arthroplasty (TKA); score range is reported between 0-100 with improvement in outcomes reflected as a higher numerical value (e.g. a 'complete' return to pre-disease functionality would be reported as a score of 100)|12 months post-operatively||||score on a scale||Standard Deviation|Mean
2566668|NCT02577978|Primary|Score for the Knee Society Score (KSS) Knee Component at 1 Year Post-operatively|Physician completed Knee Society Score questionnaire used to measure a patient's functional ability before and after total knee arthroplasty (TKA); score range is reported between 0-100 with improvement in outcomes reflected as a higher numerical value (e.g. a 'complete' return to pre-disease functionality would be reported as a score of 100)|12 months post-operatively||||score on a scale||Standard Deviation|Mean
2566669|NCT02577978|Primary|International Knee Documentation Committee (IKDC) Questionnaire Assessed Through 2 Years Post-op|The International Knee Documentation Committe (IKDC) Questionnaire is a subjective scale that provides patients with an overall function score based on a summative score for 3 sub categories (knee function, sports activities, pain/symptoms). A score between 0-100 is obtained as the sum of scores for each individual question, with increasing composite scores correlating positively with patient functional status/quality of life.|Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.||||score on a scale||Standard Deviation|Mean
2566670|NCT02577978|Primary|Total Score Calculated Using the Forgotten Joint Score in Order to Assess the Subject's Ability to Forget the Artificial Joint in Everyday Life|"Patient completed questionnaire used to assess the patients' ability to forget about a joint as a result of successful treatment. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60 where a high score indicates an improved outcome. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score with higher scores indicating improved physical function/reduced impact of symptoms on activity:~Final score = 100 - ((sum(item01 to item12) - 12)/48*100)"|12 months post-operatively||||score on a scale||Standard Deviation|Mean
2566671|NCT02577978|Primary|PROMIS Computerized Adaptive Tests (CATs) for Pain Behavior Through 2 Years Post-operative|Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Pain Behavior domain an increased value indicates greater severity/frequency of pain reported by the patient|Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.||||score on a scale||Standard Deviation|Mean
2566672|NCT02577978|Primary|PROMIS Computerized Adaptive Tests (CATs) for Pain Interference Through 2 Years Post-operative|Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Pain Interference domain an increased value indicates greater severity/frequency of pain reported by the patient.|Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.||||score on a scale||Standard Deviation|Mean
2566673|NCT02577978|Primary|PROMIS Computerized Adaptive Tests (CATs) for Physical Function Through 2 Years Post-operative|Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Physical Function domain higher scores indicated improved physical function as reported by the patient|Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.||||score on a scale||Standard Deviation|Mean
2566704|NCT02577445|Primary|Incidence of All Cause Mortality, SAEs, Stimulation Complaints, Device and/or Cardiovascular Related Events From Implant up to 5 Years.|"Collect short and long term clinical data on safety of the remede system implanted in daily practice.~This outcome measure was intended to be collected up to 5 years, but at time of early study termination the data were only monitored until 24 months for 1 patient."|From implant up to 5 years (collected until 24 month FU)|Viewing the limited amount of data at early study termination, the data should be interpreted with caution.|||Participants|||Count of Participants
2566674|NCT02577978|Primary|Veteran's RAND 12 (VR-12) Physical Composite Score (PCS) Through 2 Years Post Operative|Veteran's RAND 12 Item Health Survey used to assess health-related quality of life, to estimate disease burden, and to evaluate disease-specific benchmarks. Scores for the Physical Composite Score (MCS) range from 6.3 to 71.8 and are evaluated as a summative T-score with population mean of 50 (Standard Deviation = 10);higher scores indicate improved physical wellness/function as reported by patients.|Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.||||score on a scale||Standard Deviation|Mean
2566675|NCT02577978|Primary|Veteran's RAND 12 (VR-12) Mental Composite Score (MCS) Through 2 Years Post Operative|Veteran's RAND 12 Item Health Survey used to assess health-related quality of life, to estimate disease burden, and to evaluate disease-specific benchmarks. Scores for the Mental Composite Score (MCS) range from 5.2 to 76.3 and are evaluated as a summative T-score with population mean of 50 (Standard Deviation = 10);higher scores indicate improved mental wellness/function as reported by patients.|Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.||||score on a scale||Standard Deviation|Mean
2566676|NCT02577978|Primary|Oxford Knee Score (OKS) Pre-operative Through 2 Years Post-operative|Patient completed Oxford Knee Score questionnaire used to assess the patient's perspective of outcome following Total Knee Arthroplasty (TKA); score range is reported between 0-48 with improvement in outcomes reflected as a higher numerical value (e.g. a 'complete' return to pre-disease functionality would be reported as a score of 48)|Pre-operatively on day of surgery, 6 weeks, 3 months, 6 months, 12 months and 24 months post-operatively||||score on a scale||Standard Deviation|Mean
2566677|NCT02577900|Secondary|the Change in Concentration of Interleukin-1 Alpha (IL-1α) Level Inside Wound Fluid at Week 1 and Week 4||Week 1, Week 4||||ng/ ml||Standard Deviation|Mean
2566678|NCT02577900|Secondary|the Change in Concentration of Tumor Necrosis Factor Alpha (TNF-α) Level Inside Wound Fluid at Week 1 and Week 4||Week 1, Week 4||||ng/ ml||Standard Deviation|Mean
2566679|NCT02577900|Secondary|the Change in Concentration of Matrix Metalloproteinases-9 (MMP-9) Level Inside Wound Fluid at Week 1 and Week 4||Week 1, Week 4||||ng/ ml||Standard Deviation|Mean
2566680|NCT02577900|Secondary|Change in Ulcer Size||12 weeks||||percentage of ulcer size changes||Standard Deviation|Mean
2566681|NCT02577900|Primary|Number of Participants With Complete Healing of Ulcer During the Observation Period|The number of participants have absence of a visible wound achieved by complete epithelialization|12 weeks||||participants|||Number
2566682|NCT02577887|Secondary|Number of MRI Scans by Country|The total number of scans performed by country|1 year|All study participants|||scans|||Number
2566683|NCT02577887|Secondary|Number of Pacemaker Patients With Atrial Tachycardia/Fibrillation (AT/AF), Ventricular Tachycardia/Fibrillation (VT/VF), Pacemaker-mediated Tachycardia (PMT) and Automatic Mode Switching (AMS) Episodes|At each follow-up, devices were interrogated and device session records were uploaded. Episodes of AT/AF, VT/VF, PMT and AMS were measured by the pacemakers diagnostics features.|1 year|All patients that completed the 12-month follow-up visit.|||Participants|||Count of Participants
2566684|NCT02577887|Secondary|Number of Subjects Programmed With Advanced Pacemaker Features|Advanced pacemaker features include Autocapture, Auto sensitivity control (ASC), Ventricular Intrinsic Preference (VIP®), Patient Notifier, RF telemetry, and newer advanced features.|1 year|All study participants that completed that 12-month visit and had the feature enabled for the duration of the study. Subjects that had a change in the status of the feature (e.g. ON to OFF) are not included in the count shown here.|||Participants|||Count of Participants
2566685|NCT02577887|Primary|Percentage of Participants With Complications in the General Pacemaker Population|The rate of device related adverse events that require a medical intervention and/or hospitalization for treatment.|1 year|All subjects.|||percentage of subjects||95% Confidence Interval|Number
2566686|NCT02577822|Primary|PROMIS Computerized Adaptive Tests (CATs) for Pain Interference Through 2 Years Post-operative|Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Pain Interference domain higher scores indicated greater impact on patient's ability to perform daily activities and social function|Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.|Discrepancies between the total number of patients analyzed and patients included in participant flow is due to patients lost to follow-up during the course of the study despite attempts to contact them by the research team|||T-Score||Standard Deviation|Mean
2566687|NCT02577822|Primary|PROMIS Computerized Adaptive Tests (CATs) for Physical Function Through 2 Years Post-operative|Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Physical Function domain higher scores indicated improved physical function as reported by the patient|Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.|Discrepancies between the total number of patients analyzed and patients included in participant flow is due to patients lost to follow-up during the course of the study despite attempts to contact them by the research team|||T-Score||Standard Deviation|Mean
2566688|NCT02577822|Secondary|EBRA (Ein-Bild-Roentgen-Analyse) Femoral Component Analysis (EBRA-FCA) of Implant Subsidence Through 2 Years Post Operative|"EBRA-FCA is a commonly employed technique to evaluate implant migration via radiographic measurements taken over the duration of recovery. The mean subsidence values measured in millimeters were recorded for both the short and standard stem cohorts at each of the clinic visits for SOC.~Of note, the individual responsible for performing and recording these measurements could not be reached during upload of the final study data and consequently the dispersion values for this measure were not available at the time of publication. The dispersion values for these measures have been recorded as '0' for each time point pending any response from the individual to obtain the original data."|Assessed 6 weeks post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.||||millimeters||Standard Deviation|Mean
2566689|NCT02577822|Primary|PROMIS Computerized Adaptive Tests (CATs) for Pain Behavior Through 2 Years Post-operative|Patient-reported outcome (PRO) measures use answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function. Values are reported as T-scores with a reference population mean of 50 (SD=10); for the Pain Behavior domain higher scores indicate more frequent and severe incidence of pain during daily activities|Pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.|Discrepancies between the total number of patients analyzed and patients included in participant flow is due to patients lost to follow-up during the course of the study despite attempts to contact them by the research team|||T-Score||Standard Deviation|Mean
2566690|NCT02577822|Primary|Mean VR-12 Physical Composite Score Through 2 Years Post Operative|Veteran's RAND 12 Item Health Survey used to assess health-related quality of life, to estimate disease burden, and to evaluate disease-specific benchmarks. Scores for the Physical Composite Score (PCS) range from 6.3 to 71.8 and are evaluated as a summative T-score with population mean of 50 (Standard Deviation = 10);higher scores indicate improved mental wellness/function as reported by patients.|Assessed pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.|Discrepancies between the total number of patients analyzed and patients included in participant flow is due to patients lost to follow-up during the course of the study despite attempts to contact them by the research team|||T-Score||Standard Deviation|Mean
2566691|NCT02577822|Primary|Mean VR-12 Mental Composite Score Through 2 Years Post Operative|Veteran's RAND 12 Item Health Survey used to assess health-related quality of life, to estimate disease burden, and to evaluate disease-specific benchmarks. Scores for the Mental Composite Score (MCS) range from 5.2 to 76.3 and are evaluated as a summative T-score with population mean of 50 (Standard Deviation = 10);higher scores indicate improved mental wellness/function as reported by patients.|Assesed pre-operatively, 6 weeks post-operatively, 3 months post-operatively, 6 months post-operatively, 12 months post-operatively, and 2 years post-operatively.|Discrepancies between the total number of patients analyzed and patients included in participant flow is due to patients lost to follow-up during the course of the study despite attempts to contact them by the research team|||T-Score||Standard Deviation|Mean
2566692|NCT02577718|Secondary|Incidence of Catheter-Associated Infections|Catheter-Associated Infections will be measured by microbiological culture defined as either Catheter-Related Bloodstream Infection (CRBSI) as defined by the Infectious Diseases Society of America (IDSA), particularly in neutropenic patients, or Central Line-Associated Bloodstream Infection (CLABSI) as defined by the Centers for Disease Control and Prevention (CDC), particularly in non-neutropenic patients|60 Days|619 catheter days on NiCE Lock Solution / 1853 catheter days off NiCE Lock Solution|||infections per 1000 catheter days|catheter days||Number
2566693|NCT02577718|Primary|Number of Participants With Drug-Related Hypotension|Drug-related hypotension is defined as a significant drop in measured blood pressure (BP) that exceeds the normal BP variability of a patient by 30%, that is associated with clinical signs and symptoms (dizziness and syncope) and is unexplained by factors other than the lock solution (such as other antihypertensive drugs, sepsis, bleeding). BP variability will be based on the standard deviation (SD) of a patient's blood pressure measured in the 3 days preceding participation in this trial and will be calculated at the time of trial entry.|From date of randomization until date of first Drug-Related Hypotension within 10 minutes of each flush, assessed up to 60 days|All patients receiving at least one dose|||Participants|||Count of Participants
2566694|NCT02577601|Primary|Number of Participants With Follicle Rupture|Following dosing with UPA, subjects underwent daily visits with ultrasound monitoring until evidence of follicle rupture (complete disappearance or >50% reduction of the mean size of the leading follicle).|within 5 days of taking the study drug||||Participants|||Count of Participants
2566695|NCT02577510|Secondary|Pain With Procedure|visual analogue scale- 0-10 - 0 is equal to no pain, while 10 is equal to maximum pain|less than 30 minutes||||units on a scale|sides|Standard Deviation|Mean
2566696|NCT02577510|Secondary|Needle Pass|how often needle changes angle to make target|less than 30 minutes||||attempts|sides|Standard Deviation|Mean
2566697|NCT02577510|Secondary|Success Rate|percentage of patients with successful block|less than 30 minutes||||Participants|||Count of Participants
2566698|NCT02577510|Primary|Anesthesia Related Time|The main outcome will be the total anesthesia-related time, defined as the sum of performance and onset times|less than 30 minutes||||seconds|sides|Standard Deviation|Mean
2566699|NCT02577445|Other Pre-specified|Collect Clinical Characteristics and Symptoms of Patients With Central Sleep Apnea|Characterstics and symptoms of patients screened for sleep disordered breathing were not collected and analyzed.|screening|||||||
2566700|NCT02577445|Secondary|Incidence of All Cause Mortality and Hospitalizations up to 2 Years After Diagnosis of Central Sleep Apnea|Collect site reported safety data on all patients diagnosed with central sleep apnea and not treated with the remede system|Up to 2 years (collected until 6M FU)|No conclusion can be drawn on all-cause mortality and all-cause hospitalization rates for this group of patients;only 3 subjects diagnosed with CSA (not implanted) reached the 6M FU at the time of study termination. No deaths and/or hospitalizations had been reported in this subject group at the time of study termination.No 12M data is available.|||Participants|||Count of Participants
2566701|NCT02577445|Secondary|Change in Reverse Remodelling Response as Assessed by Echo Compared to Baseline|Evaluate reverse remodeling response in patients with reduced ejection fraction at baseline|12 months post implant|No data available; no patient had completed a 12 months echo prior to the premature study stop||||||
2566702|NCT02577445|Secondary|Impact on Quality of Life Compared to Baseline|Evaluate impact on Quality of Life by using a general questionnaire, a sleep-specific questionnaire and a questionnaire specific for heart failure patients|Up to 5 years post-implant|No data available on Quality of Life questionnaires; no patient completed the questionnaires at baseline AND at the 12M/24M follow-up at the time of premature study stop.||||||
2566703|NCT02577445|Secondary|Change in Apnea-hypopnea Index as Assessed by Polygraphy Compared to Baseline|Evaluate changes in sleep study results at 12 months compared to baseline|12 months post-implant|A complete dataset is only available for 1 patient and due to confidentiality reasons for this 1 patient we prefer not to present this data.||||||
2566705|NCT02577315|Secondary|Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)|Area under the concentration-time curve of the Metformin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity observed). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2566706|NCT02577315|Secondary|Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)|Area under the concentration-time curve of the Empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity observed). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2566707|NCT02577315|Primary|Maximum Measured Concentration of the Metformin in Plasma (Cmax)|Maximum measured concentration of the Metformin in plasma (Cmax). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2566708|NCT02577315|Primary|Maximum Measured Concentration of the Empagliflozin in Plasma (Cmax)|Maximum measured concentration of the Empagliflozin in plasma (Cmax). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2566709|NCT02577315|Primary|Area Under the Concentration-time Curve of the Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from the TS who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Thus, subject was included, even if he/she contributed only 1 PK value for one period.|||nanogram (ng)*h /millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
2566710|NCT02577315|Primary|Area Under the Concentration-time Curve of the Empagliflozin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the Empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric means (gMeans) represent adjusted gMeans and geometric coefficient of variation (gCV) reflects the intra-individual gCV (%) from the mixed model analysis.|PK plasma samples were taken at: 2 hours (h) before drug administration and 20 minutes, 40 minutes, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration.|Pharmacokinetic analysis set (PKS): all subjects from treated set (TS) who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint value that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation. Subject was included, even if he/she contributed only 1 PK value for one period.|||nanomol (nmol)* hours (h) / Litre (L)||Geometric Coefficient of Variation|Geometric Mean
2566711|NCT02577146|Secondary|The Number of Cases With Concordant Treatment Recommendations Based on the Ultrasound and CT Scan.||42 days|28 cases were not included in analysis due to screen failures, subject non-compliance and missing data.|||Cases|||Number
2566712|NCT02577146|Primary|Time in Days From Diagnosis to Stone Passage.|Number of days that have elapsed from date of diagnosis to date of stone passage or intervention to maximum observation time (42 days).|42 days|28 cases were not included in analysis due to screen failures, subject non-compliance and missing data.|||Days||95% Confidence Interval|Median
2566713|NCT02577107|Secondary|Plasma VEGF Concentration at Baseline, Visit 7, 8, 9, 10, 11 After 3rd Injection|Blood sample will be collected for systemic VEGF. VEGF will be measured by a blinded laboratory using ELISA kits. Baseline, Visit 7, 8, 9, 10, 11 after 3rd injection|Baseline, Visit 7, 8, 9, 10, 11|Per-protocol Set refers to all subjects who completed the study without any major deviation from the study protocol.|||pg/mL||Standard Deviation|Mean
2567182|NCT02570074|Secondary|Urine Fosfomycin Concentrations [mg/L]|Urine Fosfomycin concentrations [mg/L]|Day 1: 24 hours||||mg/L||Standard Deviation|Mean
2567183|NCT02570074|Secondary|Urinary Bactericidal Kinetics (UBK)||3 months|Data not collected.||||||
2566715|NCT02577107|Secondary|Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After Third Injection at Visit 10 (Day 67 +/- 1 Day)|Change from baseline in plasma Vascular endothelial growth factor (VEGF) concentration after third injection at Visit 10 (Day 67 +/- 1 day). Blood sample was collected for systemic VEGF. VEGF will be measured by a blinded laboratory using ELISA kits.|Baseline, Visit 10 (Day 67 +/- 1 day)|Per-protocol Set refers to all subjects who completed the study without any major deviation from the study protocol.|||pg/mL||Standard Deviation|Mean
2566716|NCT02577107|Primary|Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After First Injection at Visit 5 (Day 8 +/- 1 Day)|Change from baseline in plasma Vascular endothelial growth factor (VEGF) concentration after first injection at Visit 5 (Day 8 +/- 1 day).Blood sample was collected for systemic VEGF. VEGF was measured by a blinded laboratory using ELISA kits.|Baseline, Visit 5 (Day 8 +/- 1 day)|Per-protocol Set refers to all subjects who completed the study without any major deviation from the study protocol.|||pg/mL||Standard Deviation|Mean
2566717|NCT02577029|Secondary|Log Change From Baseline in Quantitative HBV Deoxyribonucleic Acid (DNA) Serum Levels Over Time||Baseline, Weeks 52, 60, 72 and 96|The study was terminated prior to any participant reaching Week 60 of treatment; therefore, this outcome measure could not be analyzed.||||||
2566718|NCT02577029|Secondary|Percentage of Participants With HDV With Undetectable HDV Ribonucleic Acid (RNA) After 48 Weeks of Concomitant ARC-520 Injection and PEG IFN Alpha 2a Therapy Over Time (Cohort 7 Only)||Weeks 52, 60, 72 and 96|The study was terminated prior to any participant reaching Week 52 of treatment; therefore, this outcome measure could not be analyzed.||||||
2566719|NCT02577029|Secondary|Percentage of Participants With Resistance to the Combination Therapy From Baseline to Week 60|Resistance is defined as > 1.0 log IU/mL increase in HBV DNA from nadir, confirmed by repeat test.|Baseline, Week 60|The study was terminated prior to any participant reaching Week 60 of treatment; therefore, this outcome measure could not be analyzed.||||||
2566720|NCT02577029|Secondary|Percentage of Participants With Resistance to ARC-520 Injection by Week 52|Resistance is defined as > 1.0 log IU/mL quantitative HBsAg (qHBsAg) increase from nadir, confirmed by repeat test.|Week 52|The study was terminated prior to any participant reaching Week 52 of treatment; therefore, this outcome measure could not be analyzed.||||||
2566721|NCT02577029|Secondary|Percentage of Participants With HBeAg Loss and Anti-Hepatitis B e Antigen (Anti-HBe) Seroconversion (if HBeAg-Positive at Study Entry) Over Time||Weeks 52, 60, 72 and 96|The study was terminated prior to any participant reaching Week 52 of treatment; therefore, this outcome measure could not be analyzed.||||||
2566722|NCT02577029|Secondary|Percentage of Participants With Anti-HBs Seroconversion Over Time||Weeks 52, 60, 72 and 96|The study was terminated prior to any participant reaching Week 52 of treatment; therefore, this outcome measure could not be analyzed.||||||
2566723|NCT02577029|Secondary|Time to Anti-HBs (Antibody to Hepatitis B Surface Antigen) Seroconversion||Baseline through Week 96|This analysis was not done since no events of HBsAg loss were observed to to Week 36. (No participant reached Week 96 of treatment due to study termination).||||||
2566724|NCT02577029|Secondary|Time to HBsAg Loss||Baseline through Week 96|This analysis was not done since no events of HBsAg loss were observed to to Week 36. (No participant reached Week 96 of treatment due to study termination).||||||
2566725|NCT02577029|Secondary|Percentage of Participants Achieving a 1-log Reduction in HBsAg and Achieving an HBsAg Level < 100 IU/L Over Time||Weeks 52, 60, 72 and 96|The study was terminated prior to any participant reaching Week 52 of treatment; therefore, this outcome measure could not be analyzed.||||||
2566726|NCT02577029|Secondary|Percentage of Participants With HBsAg Loss (Based on Qualitative Assay) Over Time|The qualitative HBsAg assay gives a binary result, positive or negative.|Weeks 52, 60, 72 and 96|The study was terminated prior to any participant reaching Week 52 of treatment; therefore, this outcome measure could not be analyzed.||||||
2566727|NCT02577029|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Considered Possibly or Probably Related to Treatment|"The Principal Investigator (or medically qualified designee) will use clinical judgment to determine the relationship. An adverse event (AE) was considered possibly related when there is a reasonable possibility that the incident, experience, or outcome may have been caused by the product under investigation. An AE was considered probably related when there are facts, evidence, or arguments to suggest that the event is related to the product under investigation. Only AEs that occurred post-dose were considered treatment-emergent. Clinically significant abnormal laboratory findings or other abnormal assessments that are detected during the study or are present at baseline and significantly worsen following the start of the study will be reported as AEs."|From first dose of study drug up to 36 weeks of treatment, plus up to 48 weeks of follow-up||||Participants|||Count of Participants
2566728|NCT02577029|Primary|Percentage of Participants Achieving a 1-log Reduction in Hepatitis B Surface Antigen (HBsAg) at Week 60 Compared to Baseline|The percentage of participants with chronic HBV achieving a 1-log reduction in HBsAg compared to baseline (mean of pre-dose values) at Week 60 after completion of 48 weeks of ARC-520 Injection.|Baseline, Week 60|The study was terminated prior to any participant reaching Week 60 of treatment; therefore, this outcome measure could not be analyzed.||||||
2566729|NCT02577016|Secondary|Change From Baseline in FPG at Week 24|Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, and treatment by time by prior use of AHAs with the constraint that the mean baseline FPG is the same for both treatment groups.|Baseline and Week 24|All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of FPG (baseline or post-baseline).|||mg/dL||95% Confidence Interval|Least Squares Mean
2566741|NCT02577003|Primary|Change From Baseline in HbA1c at Week 24|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. Statistical analysis based on a constrained longitudinal data analysis (cLDA) model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline HbA1c is the same for both treatment groups.|Baseline and Week 24|All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of HbA1c (baseline or post-baseline).|||Percent||95% Confidence Interval|Least Squares Mean
2566730|NCT02577016|Secondary|Change From Baseline in Glucose Total Area Under the Plasma Concentration Curve From Hour 0 to Hour 2 (AUC0-2hr) After Meal at Week 24|Change from Baseline in Glucose Total AUC0-2hr after Meal at Week 24 is defined as Week 24 Glucose Total AUC0-2hr after a meal minus Week 0 Glucose Total AUC0-2hr after a meal. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, and treatment by time by prior use of AHAs with the constraint that the mean baseline glucose total AUC0-2hr after meal is the same for both treatment groups.|Baseline and Week 24 (just before loading meal [0 min], 30 min, 60 min and 120 min)|All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of glucose total AUC0-2hr after meal (baseline or post-baseline).|||mg･hr/dL||95% Confidence Interval|Least Squares Mean
2566731|NCT02577016|Secondary|Change From Baseline in 2-hr PMG at Week 24|Change from baseline in 2-hr PMG at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, and treatment by time by prior use of AHAs with the constraint that the mean baseline 2-hr PMG is the same for both treatment groups.|Baseline and Week 24|All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of 2-hr PMG (baseline or post-baseline).|||mg/dL||95% Confidence Interval|Least Squares Mean
2566732|NCT02577016|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 24 weeks|All randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
2566733|NCT02577016|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 26 weeks|All randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
2566734|NCT02577016|Primary|Change From Baseline in HbA1c at Week 24|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent. Statistical analysis based on a constrained longitudinal data analysis (cLDA) model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, and treatment by time by prior use of AHAs with the constraint that the mean baseline is the same for both treatment groups.|Baseline and Week 24|All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of HbA1c (baseline or post-baseline).|||Percent||95% Confidence Interval|Least Squares Mean
2566735|NCT02577003|Secondary|Change From Baseline in Body Weight at Week 24|Change from baseline in body weight at Week 24 is defined as Week 24 body weight minus Week 0 body weight. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs and treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline body weight is the same for both treatment groups.|Baseline and Week 24|All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of body weight after meal (baseline or post-baseline).|||kg||95% Confidence Interval|Least Squares Mean
2566736|NCT02577003|Secondary|Change From Baseline in Glucose Total AUC0-2hr After Meal at Week 24|Change from baseline in glucose total AUC0-2hr after meal at Week 24 is defined as Week 24 glucose total AUC0-2hr after a meal minus Week 0 glucose total AUC0-2hr after a meal. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs and treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline glucose total AUC0-2hr after meal is the same for both treatment groups.|Baseline and Week 24 (just before the loading meal [0 min], 30 min, 60 min and 120 min)|All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of glucose total AUC0-2hr after meal (baseline or post-baseline).|||mg･hr/dL||95% Confidence Interval|Least Squares Mean
2566737|NCT02577003|Secondary|Change From Baseline in 2-hr PMG at Week 24|Change from baseline in 2-hr PMG at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline 2-hr PMG is the same for both treatment groups.|Baseline and Week 24|All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of 2-hr PMG (baseline or post-baseline).|||mg/dL||95% Confidence Interval|Least Squares Mean
2566738|NCT02577003|Secondary|Change From Baseline in FPG at Week 24|Change from baseline in FPG at Week 24 is defined as Week 24 FPG minus Week 0 FPG. Statistical analysis based on a cLDA model with terms for treatment, time, prior use of AHAs, the interactions of treatment by time, time by prior use of AHAs, treatment by time by prior use of AHAs, and baseline eGFR value with the constraint that the mean baseline FPG is the same for both treatment groups.|Baseline and Week 24|All randomized participants who received at least one dose of treatment period study medication and have at least one measurement of FPG (baseline or post-baseline).|||mg/dL||95% Confidence Interval|Least Squares Mean
2566739|NCT02577003|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 24 weeks|All randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
2566740|NCT02577003|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 26 weeks|All randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
2566742|NCT02576977|Secondary|Second Progression Free Survival (PFS2)|PFS2 was defined as the time from randomization to subsequent disease progression after initiation of new anti-cancer therapy, or death from any cause, whichever occurred first, by investigator assessment. PFS was assessed by CAC blinded central review according to the IMWG response criteria based on the development of new bone lesions or soft tissue plasmacytomas or on a definite increase in the size of existing bone lesions or soft tissue plasmacytomas. PFS2 was not completed due to incomplete enrollment due to a clinical hold.|Up to approximately 30 months|The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized. PFS2 was not completed due to incomplete enrollment due to a clinical hold.||||||
2566743|NCT02576977|Secondary|Disease Control Rate (DCR) Evaluated According to the IMWG Response Criteria by CAC Blinded Central Review|Disease control rate was the percentage of participants who achieved confirmed sCR, CR, VGPR, PR, or have demonstrated stable disease (SD) for at least 12 weeks prior to any evidence of progression and not meeting the criteria for CR, VGPR, PR, or progressive disease (PD). PD was development of or an increase in the size of bone lesions or soft tissue plasmacytomas. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum FLC assay ratio and absence of clonal cells in bone marrow by immunohistochemistry/fluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. The data cutoff date was July 9, 2018.|Up to approximately 30 months|The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2566744|NCT02576977|Secondary|Participants Discontinuing Study Investigational Product Due to an AE|An adverse event was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.|Up to approximately 21 months|The analysis population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Participants|||Count of Participants
2566745|NCT02576977|Secondary|Participants Experiencing One or More Adverse Events (AEs)|An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.|Up to approximately 33 months|The analysis population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Participants|||Count of Participants
2566746|NCT02576977|Secondary|Overall Response Rate (ORR) Evaluated According to the IMWG Response Criteria by CAC Blinded Central Review|ORR was defined as the percentage of the participants in the analysis population who achieved at least a partial response (stringent complete response [sCR]+complete response [CR]+very good partial response [VGPR]+partial response [PR]) according to the IMWG. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. The data cutoff date was July 9, 2018.|Up to approximately 30 months|The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2566747|NCT02576977|Primary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Median overall survival was calculated from the product-limit (Kaplan-Meier) method for censored data. The data cutoff date was July 9, 2018.|Up to approximately 30 months|The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2566748|NCT02576977|Primary|Progression Free Survival (PFS) Assessed by Clinical Adjudication Committee (CAC) Blinded Central Review According to the International Myeloma Working Group (IMWG) Response Criteria|Progression free survival was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. PFS was assessed by CAC blinded central review according to the IMWG criteria based on the development of new bone lesions or soft tissue plasmacytomas or on a definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Median PFS was calculated from the product-limit (Kaplan-Meier) method for censored data. The data cutoff date was July 9, 2018.|Up to approximately 30 months|The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2566749|NCT02576951|Secondary|Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP|Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP.|Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable plasma Cmax CGRP data in Part B.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2566750|NCT02576951|Secondary|Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP)|Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve from time zero to tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP).|Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable plasma AUC zero to tlast CGRP data in Part B.|||day*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2566751|NCT02576951|Secondary|Part B: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP)|Part B: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP).|Part B: Predose, 8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable plasma Tmax CGRP data in Part B.|||Days||Full Range|Median
2566752|NCT02576951|Secondary|Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP|Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP.|Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable plasma Cmax CGRP data in Part A.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2566753|NCT02576951|Secondary|Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC [0 to Tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP)|Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC [0 to Tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP).|Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable plasma AUC CGRP data in Part A.|||day*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2566754|NCT02576951|Secondary|Part A: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP)|Part A: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP).|Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable plasma Tmax CGRP data in Part A.|||Days||Full Range|Median
2566755|NCT02576951|Primary|Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab|Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.|Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose|All randomized participants who received at least one dose of study drug in part B and had evaluable Cmax PK data.|||Microgram per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2566756|NCT02576951|Primary|Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity of Galcanezumab|Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) from Time Zero to Infinity of Galcanezumab.|Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose|All randomized participants who received at least one dose of study drug in Part B and had evaluable AUC zero to infinity PK data.|||day*microgram per milliliter(day*μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2566757|NCT02576951|Primary|Part A: Number of Participants With an Injection Site Adverse Event|If an injection site reaction is present, it will be fully characterized (including erythema, induration, pain, itching). A summary of other nonserious adverse event (AE), and all serious adverse events (SAE), regardless of causality, is located in the reported adverse events section.|Part A: Predose through 48 hours post dose|All randomized participants who received at least one dose of study drug in Part A and had at least one post dose safety assessment.|||Participants|||Count of Participants
2566758|NCT02576938|Secondary|Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Baricitinib|Pharmacokinetics (PK): Maximum serum concentration (Cmax) of Baricitinib|Week (Wk) 0: Predose, 15-30 minutes (min) postdose; Wk 4: 1.5 - 4 hour (hr) postdose; Wk 8: 4 - 8 hr postdose; Wk 12: Predose; Wk 16: 30 - 90 min postdose.|All participants who received at least 1 dose of study drug and provided at least 1 post-dose PK sample. PK sample was not collected for the placebo group.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2566759|NCT02576938|Secondary|Change From Baseline in the Itch Numerical Rating Scale (NRS) at Week 16|"The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participant's itching is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Changes from baseline were analyzed with an MMRM with fixed effects for treatment, time, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit were included as covariates."|Baseline, Week 16|All participants who received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2566760|NCT02576938|Secondary|Change From Baseline in the Dermatologic Life Quality Index (DLQI) at Week 16|"The DLQI is a simple, participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include Not at all, A little, A lot, and Very much, with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of Not relevant which is scored as 0. For all questions, if unanswered the question is scored as 0. Totals range from 0 to 30 (less to more impairment). Changes from baseline in DLQI score were analyzed with an MMRM with fixed effects for treatment, time, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit were included as covariates."|Baseline, Week 16|All participants who have received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2566761|NCT02576938|Secondary|Change From Baseline in the Investigator's Global Assessment (IGA) at Week 16|The IGA consists of a 6-point severity scale to measure characteristics of erythema, infiltration, papulation, oozing and crusting as guidelines for the overall severity assessment. The scale ranges from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease).|Baseline, Week 16|All participants who received at least one dose of study drug and had IGA data at Week 16 .|||units on a scale||Standard Deviation|Mean
2566779|NCT02576652|Secondary|Remodeling-based Formation Units Including Overfilled Units in the Femoral Neck|"Femoral neck bone samples were prepared according to standard procedures for bone histology and bone histomorphometry at a central bone histomorphometry facility.~Remodeling based formation units in active bone‐forming, tetracycline‐labeled surfaces were identified by a scalloped cement line. The number of remodeling based formation units including overfilled units was evaluated at the cancellous, periosteal, and endocortical regions and is reported in units per mm of bone surface."|Days 22-58 (at the time of hip replacement surgery)|Enrolled participants who had an evaluable biopsy for fluorochrome labeling.|||units/mm||Standard Deviation|Mean
2566762|NCT02576938|Secondary|Change From Baseline in the Scoring Atopic Dermatitis (SCORAD) at Week 16|The SCORAD index uses the rule of nines to assess disease extent and evaluates five clinical characteristics to determine disease severity: (1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation and (5) lichenification. SCORAD also assesses subjective symptoms of pruritus and sleep loss with Visual Analogue Scales (VAS) where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These three aspects: extent of disease (A: 0-102), disease severity (B: 0-18) and subjective symptoms (C:0-20) combine using A/5 + 7*B/2+ C to give a maximum possible score of 103 where 0 = no disease and 103 = severe disease. Changes from baseline were analyzed with an MMRM with fixed effects for treatment, visit, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit included as covariates.|Baseline, Week 16|All participants who received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2566763|NCT02576938|Secondary|Percentage Change From Baseline in the EASI at Week 16|The Eczema Area and Severity Index (EASI) assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe. Changes from baseline were analyzed with an MMRM with fixed effects for treatment, visit, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit included as covariates.|Baseline, Week 16|All participants who received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2566764|NCT02576938|Secondary|Change From Baseline in the EASI at Week 16|The Eczema Area and Severity Index (EASI) assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe. Change from baseline were analyzed with a Mixed-effect Model Repeated Measure (MMRM) with fixed effects for treatment, visit, country, and the treatment-by-visit interaction, plus baseline and baseline-by-visit included as covariates.|Baseline, Week 16|All participants who received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2566765|NCT02576938|Primary|Percentage of Participants With a 50% or Greater Reduction in the Eczema Area and Severity Index (EASI 50)|The EASI 50, defined as ≥ 50% reduction from baseline in EASI score, assesses extent of disease based on dividing the skin into 4 regions (head/neck, trunk, upper limbs, and lower limbs) and measures the following clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3.The EASI confers a maximum score of 72 with 0 = clear; 0.1 -1 = almost clear; 1.1 -7 = mild; 7.1 - 21 = moderate; 21.1 - 50 = severe; 50.1 - 72 = very severe.|Week 16|All participants who received at least one dose of study drug and had EASI 50 data at Week 16.|||percentage of participants|||Number
2566766|NCT02576899|Primary|Quality of Life as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire|The Quality of Life Enjoyment and Satisfaction Questionnaire is a commonly used self-report measure to assess quality of life in several domains: general activities, physical health, subjective feelings, leisure time activities, social relationships, work, and household duties. Higher scores indicate better enjoyment and satisfaction with life. The scoring of the Quality of Life Enjoyment and Satisfaction Questionnaire involves summing the first 14 items to yield a total score. The total score ranges from 14 to 70 and is expressed as a percentage based on the maximum total score of the items completed (0-100).|Change in Quality of Life from Baseline to from Baseline to End of Treatment (12 week outcome)||||units on a scale||Standard Deviation|Mean
2566767|NCT02576899|Primary|Functional Impairment as Measured by the Mental Health Subscale of The Short Form 36 Health Survey (SF-36)|The Short Form 36 Health Survey (SF-36) is a 36-item self-report measure of current physical, mental health, and social functioning. We are reporting the mental health functioning outcome. A total score was computed by summing and transforming the five-item scores into a score between 0 (lowest mental health) and 100 (highest mental health). Lower scores indicate more severe functioning related to mental health problems.|Change in Functional Impairment from Baseline to End of Treatment (12 week outcome)||||units on a scale||Standard Deviation|Mean
2566768|NCT02576899|Primary|PTSD Symptoms as Measured by the PTSD Checklist (PCL-5)|The PCL-5 is a brief, self-report symptom checklist that assesses the 20 symptoms of PTSD outlined in the Diagnostic and Statistical Manual-5 (DSM-5) and was designed to assess symptom changes during and after treatment in addition to screening. The PCL has shown satisfactory temporal stability, internal consistency, test-retest reliability, and convergent validity. The minimum value of the PCL-5 is 0, and the maximum value is 80. Higher scores indicate more severe PTSD symptoms.|Change in PTSD symptoms from Baseline to End of Treatment (12 week outcome)||||units on a scale||Standard Deviation|Mean
2566769|NCT02576899|Primary|7-day Point Prevalence of Smoking Abstinence|Smoking outcomes will include a self-report of the number of cigarettes smoked at end of treatment, 1-month follow-up, and the 3-month follow-up, verified by carbon monoxide (CO) breath tests (< 8 ppm).|Change in smoking abstinence from Baseline to End of Treatment (12 week outcome)||||Participants|||Count of Participants
2566770|NCT02576678|Primary|Terminal Phase Elimination Half-Life|Terminal-phase elimination half-life (t ½). PK parameters were calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.|For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.|The PK population included all enrolled participants who received one dose of apremilast and had evaluable PK data. PK data was considered evaluable if there were measurable drug levels of apremilast in plasma from at least 3 time points that extended over a minimal 5-hour period within 12 hours post a dose, eg, predose, 2 and 8 hours post a dose.|||hours||Geometric Coefficient of Variation|Geometric Mean
2566771|NCT02576678|Secondary|Taste and Acceptability of Apremilast Tablets Using the Faces Likert Scale|Taste and acceptability of the apremilast tablet was assessed using a faces Likert Scale on Day 1, initial dosing. The scale consists of options from 1 (dislike very much, illustrated by a frowning face) to 5 (like very much, illustrated by a smiling face).|Day 1|The Safety Population consisted of all participants who received at least 1 dose of apremilast.|||Participants|||Count of Participants
2566772|NCT02576678|Primary|Apparent Total Volume of Distribution When Dosed Orally, Based on Study-State (Vss/F) or in the Terminal Phase (Vz/F)|Apparent total volume of distribution when dosed orally, based on study-state (Vss/F) or in the terminal phase (Vz/F). Pharmacokinetic parameters were calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.|For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.|The PK population included all enrolled participants who received one dose of apremilast and had evaluable PK data. PK data was considered evaluable if there were measurable drug levels of apremilast in plasma from at least 3 time points that extended over a minimal 5-hour period within 12 hours post a dose, eg, predose, 2 and 8 hours post a dose.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2566773|NCT02576678|Primary|Apparent Total Plasma Clearance When Dosed Orally (CL/F) for Apremilast|Apparent total plasma clearance (CL/F) of apremilast was calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.|For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.|The PK population included all enrolled participants who received one dose of apremilast and had evaluable PK data. PK data was considered evaluable if there were measurable drug levels of apremilast in plasma from at least 3 time points that extended over a minimal 5-hour period within 12 hours post a dose, eg, predose, 2 and 8 hours post a dose.|||Liters/hour||Geometric Coefficient of Variation|Geometric Mean
2566774|NCT02576678|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration of Apremilast (AUC0-t)|Area under the plasma concentration-time curve from time zero to the last quantifiable time point and was calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.|For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.|The PK population included all enrolled participants who received one dose of apremilast and had evaluable PK data. PK data was considered evaluable if there were measurable drug levels of apremilast in plasma from at least 3 time points that extended over a minimal 5-hour period within 12 hours post a dose, eg, predose, 2 and 8 hours post a dose.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2566775|NCT02576678|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose of Apremilast (AUC0-12)|Area under the plasma concentration-time curve from time zero to the 12 hours post dose was calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.|For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.|The PK population included all enrolled participants who received one dose of apremilast and had evaluable PK data. PK data was considered evaluable if there were measurable drug levels of apremilast in plasma from at least 3 time points that extended over a minimal 5-hour period within 12 hours post a dose, eg, predose, 2 and 8 hours post a dose.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2566776|NCT02576678|Primary|Time to Maximum Plasma Concentration (Tmax) of Apremilast|Time to maximum observed plasma concentration obtained directly from the observed concentration versus time data. PK parameters were calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.|For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.|The PK population included all enrolled participants who received one dose of apremilast and had evaluable PK data. PK data was considered evaluable if there were measurable drug levels of apremilast in plasma from at least 3 time points that extended over a minimal 5-hour period within 12 hours post a dose, eg, predose, 2 and 8 hours post a dose.|||hours||Full Range|Median
2566777|NCT02576678|Primary|Maximum Observed Plasma Concentration (Cmax) of Apremilast|Maximum observed plasma concentration (Cmax) of apremilast. PK parameters were calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.|For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.|The PK population included all enrolled participants who received one dose of apremilast and had evaluable PK data. PK data was considered evaluable if there were measurable drug levels of apremilast in plasma from at least 3 time points that extended over a minimal 5-hour period within 12 hours post a dose, eg, predose, 2 and 8 hours post a dose.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2566778|NCT02576678|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|A TEAE is an adverse event with a start date on or after the date of the first dose of apremilast and no later than 28 days after the last dose of apremilast. An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. A serious AE is any untoward AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization or in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or constitutes an important medical event. The investigator assessment of severity/intensity of an event was defined as mild, moderate or severe.|From first dose of apremilast until 28 days after the last dose; up to 29 July 2019; median treatment duration for adolescents apremilast 20 mg and 30 mg was 50.00 and 50.57 weeks respectively and for children was 50.00 weeks.|The safety population consisted of all participants who received at least 1 dose of apremilast|||Participants|||Count of Participants
2567184|NCT02570074|Secondary|Urinary Bactericidal (UBT) Titers for E. Coli ATCC 25922|UBT for E.coli ATCC 25922|3 months||||Reciprocal Titers||Inter-Quartile Range|Median
2567185|NCT02570074|Secondary|Amount Excreted in the Urine (Ae)||Pooled over 24 hours at Day 1 and Day 5||||mg||Standard Deviation|Mean
2566780|NCT02576652|Secondary|Overfilled Remodeling-based Formation Units in the Femoral Neck|"Femoral neck bone samples were prepared according to standard procedures for bone histology and bone histomorphometry at a central bone histomorphometry facility.~Remodeling-based formation units in active bone‐forming, tetracycline‐labeled surfaces were identified by a scalloped cement line. The number of overfilled remodeling-based formation units was evaluated at the cancellous, periosteal, and endocortical regions and is reported as units per mm of bone surface."|Days 22-58 (at the time of hip replacement surgery)|Enrolled participants who had an evaluable biopsy for fluorochrome labeling.|||units/mm||Standard Deviation|Mean
2566781|NCT02576652|Secondary|Modeling Based Formation Units in the Femoral Neck|"Femoral neck bone samples were prepared according to standard procedures for bone histology and bone histomorphometry at a central bone histomorphometry facility.~Modeling based formation units in active bone‐forming, tetracycline‐labeled surfaces were identified by a smooth cement line. The number of modeling based formation units was evaluated at the cancellous, periosteal, and endocortical regions and is reported in units per mm of bone surface."|Days 22-58 (at the time of hip replacement surgery)|Enrolled participants who had an evaluable biopsy for fluorochrome labeling.|||units/mm||Standard Deviation|Mean
2566782|NCT02576652|Primary|Percentage of Participants With Modeling Based Bone Formation in the Femoral Neck|"Femoral neck bone samples were prepared according to standard procedures for bone histology and bone histomorphometry at a central bone histomorphometry facility.~Modeling based formation units in active bone‐forming, tetracycline‐labeled surfaces were identified by a smooth cement line.~The percentage of participants with fluorochrome labeling present in the cancellous or periosteal, or endocortical surfaces of the femoral neck indicative of modeling-based bone formation is reported."|Days 22-58 (at the time of hip replacement surgery)|All enrolled participants who had an evaluable biopsy for fluorochrome labeling.|||percentage of participants|||Number
2566783|NCT02576639|Secondary|Apparent Volume of Distribution (Vz/F)||Day 91|This PK parameter was not analyzed because data was not collected.||||||
2566784|NCT02576639|Secondary|Area-under-plasma Concentration Time Curve up to Infinity (AUCinf)|CNP520 concentrations in plasma|Day 91|This PK parameter was not analyzed because data was not collected.||||||
2566785|NCT02576639|Secondary|Summary of CSF PK Concentrations|CSF samples were collected by lumbar puncture for assessment.|Days 1, 14, 28, 42, 56, 70 and 91|The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.|||ng/mL||Standard Deviation|Mean
2566786|NCT02576639|Secondary|Summary of Plasma PK Parameter: Racc|Racc = the accumulation ratio . Blood samples were collected to assess Racc.|Day 91|The PK analysis set was used for the analysis. Only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed.|||ratio||Standard Deviation|Mean
2566787|NCT02576639|Secondary|Summary of PK Parameter: CLss/F|CLss/F = the apparent systemic clearance from plasma observed during a dosing interval at steady state following extravascular administration. Blood samples were collected to assess CLss/F.|Day 91|The PK analysis set was used for the analysis. Only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed.|||mL/h||Standard Deviation|Mean
2566788|NCT02576639|Secondary|Summary of Plasma PK Parameter: T1/2|T1/2 = the terminal elimination half-life. Blood samples were collected to assess T/12.|Day 91|The PK analysis set was used for the analysis. Only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed.|||hour||Standard Deviation|Mean
2566789|NCT02576639|Secondary|Summary of Plasma PK Parameter: Tlag|Tlag = time delay between drug administration and first observed concentration above the lower limit of quantification (LOQ) in plasma . Blood samples were collected to assess Tlag.|Days 1 and 91|The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.|||hour||Full Range|Median
2566790|NCT02576639|Secondary|Summary of Plasma PK Parameter: Tmax|Tmax = the time to reach the maximum concentration after drug administration. Blood samples were collected to assess Tmax.|Days 1 and 91|The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.|||hour||Full Range|Median
2566791|NCT02576639|Secondary|Summary of Plasma PK Parameter: AUCtau|AUCtau = the area under the plasma concentration-time curve from zero to the end of the dosing interval tau. Blood samples were collected to assess AUCtau.|Days 1 and 91|The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.|||h*ng/mL||Standard Deviation|Mean
2566792|NCT02576639|Secondary|Summary of Plasma PK Parameter: Cmax|Cmax = the observed maximum plasma concentration following drug administration. Blood samples were collected to assess Cmax. The PK analysis set was used for the analysis.|Days 1, 91|The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point.|||ng/mL||Standard Deviation|Mean
2566793|NCT02576639|Secondary|Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations|CSF samples were collected by lumbar puncture for assessment.|Day 92|The pharmacodynamics (PD) analysis set was analyzed. The PD set included only randomized participants who had available PD data and no protocol deviations with relevant impact on PD data.|||Percentage change||Standard Deviation|Mean
2566794|NCT02576639|Primary|Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths|Safety monitoring was conducted throughout the study.|13 weeks|The safety analysis set, which included participants who received at least 1 dose of study drug (CNP520 or placebo), was analyzed.|||Participants|||Number
2566891|NCT02575079|Secondary|Perception of Parafilm|The perception of parafilm from provider and caregiver surveys regarding parafilm ease of use, perceived benefit, and other parameters will be reported|Month 3 (average time till removal of CVC)|A survey was initially planned for in the protocol but was removed from the study procedures prior to any participants completing the survey.||||||
2566795|NCT02576587|Secondary|Vascular Measures- Augmentation Index|"Augmentation Index (Alx) is an indication of systemic arterial stiffness and measures the contributions of wave reflection to central systolic pressure. Scores vary based on age and gender and in a normal, healthy population research has shown can range from -10% or less up to 50%. A negative augmentation index suggests low artery stiffness (late arriving wave reflections) and a positive index is a reflection of increase artery stiffness (reflective wave arriving early in the cardiac cycle). Waveforms will be processed using the SphygmoCor software (model EM3, version CvMS 9.0, Atcor Medical Pty, West Ryde, Australia) for this measurement.~It is calculated at the onset of reflected wave, Alx = AP/PP x 100. Alx = Augmentation Index, the percentage of the pulse pressure due to the AP; PP = Pulse Pressure; AP = Augmentation Pressure, the contribution of the reflected wave to the pulse pressure."|Baseline and 12 week follow up|Cases selected for follow-up and having available SphygmoCor measurements|||percentage of augmentation pressure||Standard Deviation|Mean
2566796|NCT02576587|Secondary|Vascular Measures- Pulse Wave Velocity|Radial measurements were performed on the same arm using the SphygmoCor device after sphygmomanometric pressure was obtained with use of an applanation tonometry probe containing a solid state high fidelity Millar transducer over the radial artery with a minimum of two consecutive measurements to obtain pulse wave analysis results. For pulse wave velocity, lead II ECG (LL, LA, RA) was performed along with cardotid and femoral applanation tomometry. Orientation and pressure applied to the transducer were adjusted to optimize applanation of the artery between the transducer and the underlying tissue. Waveforms were processed using the SphygmoCor software (model EM3, version CvMS 9.0, Atcor Medical Pty, West Ryde, Australia).)|Baseline and 12 week follow up|Cases selected for follow-up and having available SphygmoCor measurements|||m/s||Standard Deviation|Mean
2566797|NCT02576587|Secondary|Echocardiographic Measures- LA Systolic Strain by A2C View|Left atrial systolic strain, a measure of left atrial remodeling which is inversely related to fibrosis in PAF, is measured by 2-dimensional echocardiography. Apical four-chamber (A4C) and two-chamber (A2C) views are the most commonly used approaches to measure the strain rate (%) of left atrial.|Baseline and 12 week follow up||||percentage of left atrial volume||Inter-Quartile Range|Median
2566798|NCT02576587|Secondary|Echocardiographic Measures- LA Systolic Strain by A4C View|Left atrial systolic strain, a measure of left atrial remodeling which is inversely related to fibrosis in PAF, is measured by 2-dimensional echocardiography. Apical four-chamber (A4C) and two-chamber (A2C) views are the most commonly used approaches to measure the strain rate (%) of left atrial.|Baseline and 12 week follow up||||percentage of left atrial volume||Inter-Quartile Range|Median
2566799|NCT02576587|Secondary|Echocardiographic Measures- LA Volume Index|"Increased left atrial volume and strain are known risk factors of AF and PAF. Left atrial volume index (LAVI) is left atrial size indexed to Body surface area (BSA). The reference range of LAVI is 16-28 mL/m^2.~Mildly abnormal: 29-33 mL/m^2; Moderately abnormal: 34-39 mL/m^2; Severely abnormal: greater than or equal to 40 mL/m^2.~Echocardiography measurements were not available for some subjects due to image quality."|Baseline and 12 week follow up||||mL/m^2||Inter-Quartile Range|Median
2566800|NCT02576587|Secondary|Echocardiography Measures- Left Atrial Volume|Increased left atrial volume and strain are known risk factors of AF and PAF. Echocardiography measurements were not available for some subjects due to image quality.|Baseline and 12 week follow up|Cases found to have an apnea hypopnea index >=15 were asked to continue in the study for 3 months wearing a Continuous Positive Airway Pressure (CPAP) machine.|||mL||Inter-Quartile Range|Median
2566801|NCT02576587|Primary|Number of Participants With Paroxymal Atrial Fibrillation (PAF)|Patients with diagnosis of PAF were defined as cases. PAF is the primary outcome of baseline analysis, which aimed to quantify the association of sleep apnea and PAF.|Baseline|Cases and controls who had matched control/case were included in baseline analysis. Only 150 cases were one-to-one matched with controls.|||Participants|||Count of Participants
2566802|NCT02576535|Post-Hoc|Number of Participants Experiencing Seizures||10 years||||participants|||Number
2566803|NCT02576535|Primary|Number of Participants With Complete Occlusion of AVM on Serial MRI Confirmed With Angiography||10 years||||participants|||Number
2566804|NCT02576535|Primary|Number of Participants Experiencing Hemorrhage From the Arteriovenous Malformation (AVM)||10 years||||participants|||Number
2566805|NCT02576535|Primary|Number of Participants With Presence of New Neurological Symptoms Without Evidence of MRI Abnormalities||10 years||||participants|||Number
2566806|NCT02576535|Primary|Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Associated With New Neurological Symptoms||10 years||||participants|||Number
2566807|NCT02576535|Secondary|Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms||10 years||||participants|||Number
2566808|NCT02576249|Secondary|Tegner Activity Level Scale|"The Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury.~A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score >6 can only be achieved if the person participates in recreational or competitive sport."|baseline (pre-injection), 2 weeks, 3 months||||units on a scale||Standard Deviation|Mean
2566809|NCT02576249|Secondary|Pain Scale Score|Pain was measured by a Visual Analog Scale (VAS) marked from 0 (no pain) to 10 (unbearable pain) at rest and with activity. It was collected at baseline (pre-injection), immediately post-injection on the day of surgery, and at 2 weeks and 3 months.|Pre-injection, immediately post-injection, 2 weeks, 3 months||||units on a scale||Standard Deviation|Mean
2566810|NCT02576249|Primary|The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale|The KOOS holds 42 items in five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.|3 months after the injection||||units on a scale||Standard Deviation|Mean
2567186|NCT02570074|Secondary|Renal Clearance (CLR)||Pooled over 24 hours at Day 1 and Day 5||||L/h||Standard Deviation|Mean
2566811|NCT02576145|Secondary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes|Up to Month 12|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.|||participants|||Number
2566812|NCT02576145|Secondary|Number of Participants With a Positive Delayed Type Hypersensitivity (DTH) Response After KLH Immunization|DTH skin reactions were assessed 48 hours after each KLH immunization given on Day 1 and on Day 29. A positive response was defined as an induration >=5 mm.|Day 1 and Day 29|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.|||participants|||Number
2566813|NCT02576145|Secondary|Number of KLH Antibody Nonresponders Who Underwent Rechallenge and Mounted a KLH Antibody Response|Nonresponders (participants who failed to mount antibody responses to KLH) were rechallenged with KLH 6 months after Day 29 (Day 196). For nonresponders, positive antibody response to KLH was defined as at least a 2-fold increase in antibody concentration at any time point up to Day 252 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. All humoral responses were assessed by enzyme-linked immunosorbent assay (ELISA).|Up to Day 252|All patient population: All participants who were enrolled in the study and received at least 2 vaccine doses were included in this population. Only participants who were KLH Antibody nonresponders were evaluated.|||participants|||Number
2566814|NCT02576145|Secondary|Percentage of Participants With Positive Antibody Response to KLH Immunization at Month 6|Positive antibody response was defined as at least a 2-fold increase in antibody concentration on Month 6 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. All humoral responses were assessed by enzyme-linked immunosorbent assay (ELISA). Due to the small number of participants enrolled in the study, percentage of participants with positive antibody response to KLH immunization at Month 6 was not reported.|Month 6|||||||
2566815|NCT02576145|Secondary|Mean Percent Expression of HLA-DR+, CD45RO+ and CD45RA+|Blood samples were obtained for flow activated cell sorter (FACS) analyses of HLA-DR+, CD45RO+ and CD45RA+ on Days 1, 29, and 57. These cells are present on white blood cells and are used as markers to associate cells with immune functions.|Days 1, 29 and 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.Only participants with data available at a particular time point were analyzed.|||Percent expression||Standard Deviation|Mean
2566816|NCT02576145|Secondary|Mean Percent Expression of CD3, CD4, and CD8|Blood samples were obtained for flow activated cell sorter (FACS) analyses of T cell subsets (CD3, CD4, and CD8) on Days 1, 22, 29, 43, and 57. These cells are present on white blood cells and are used as markers to associate cells with immune functions.|Days 1, 22, 29, 43 and 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population. Only participants with data available at a particular time point were analyzed.|||Percent expression||Standard Deviation|Mean
2566817|NCT02576145|Secondary|Mean Percent Expression of 2A3/CD25+ Antibody|CD25 is an antigen that is present on a subset of peripheral blood lymphocytes. The expression of CD25+ on T cell was investigated using antibody 2A3. Blood samples were drawn for evaluation of CD25+ at screening and on Days 29, 57, and 168.|Screening, Day 29, Day 57 and Day 168|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population. Only participants with data available at a particular time point were analyzed.|||Percent expression||Standard Deviation|Mean
2566818|NCT02576145|Secondary|Geometric Mean Antibody Concentrations for KLH (IgM and IgG) and TT (IgG)|Due to the small number of participants enrolled in the study, geometric means at Baseline and on Days 22, 29, 43 and 57 were not reported.|Screening, Day 22, Day 29, Day 43 and Day 57|||||||
2566819|NCT02576145|Secondary|Number of Tetanus Cellular Nonresponders Who Were Rechallenged and Mounted a Cellular Tetanus Response|Nonresponders (participants who mount humoral responses but no cellular responses to tetanus vaccination) were rechallenged with TT 6 months after Day 29 (Day 196). For nonresponders, positive cellular response to TT was defined as an increase in the BrdU percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, at any time point up to Day 252. All cellular responses were assessed by BrdU proliferation assay.|up to Day 252|All patient population: All participants who were enrolled in the study and received at least 2 vaccine doses were included in this population. Only participants who were tetanus cellular nonresponders were evaluated.|||participants|||Number
2566820|NCT02576145|Secondary|Number of KLH Cellular Nonresponders Who Were Rechallenged and Mounted a Cellular Response to KLH Immunization|Nonresponders (participants who failed to mount cellular responses to KLH) were rechallenged with KLH 6 months after Day 29 (Day 196). For nonresponders, positive cellular response to KLH was defined as an increase in the 5-bromo-2-deoxyuridine (BrdU) percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point up to Day 252. All cellular responses were assessed by BrdU proliferation assay.|Up to Day 252|All patient population: All participants who were enrolled in the study and received at least 2 vaccine doses were included in this population. Only participants who were KLH cellular nonresponders were evaluated.|||participants|||Number
2566832|NCT02576054|Secondary|Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 30 Months|Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay. Antibody titers were expressed as mMU/mL.|24 months postdose 3 (30 months)|All participants that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 30 data within an acceptable date range of 24 months postdose 3.|||mMU/mL||95% Confidence Interval|Geometric Mean
2566935|NCT02573779|Secondary|Rates of Late-onset Sepsis|the number of patients with late-onset sepsis will be collected|6-10 weeks||||Participants|||Count of Participants
2566821|NCT02576145|Secondary|Number of Participants Who Developed a Positive Antibody Response to KLH and Positive Cellular Responses to Both KLH and TT Immunizations|Positive antibody response was defined as at least a 2-fold increase in antibody concentration on either Day 43 or Day 57 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. Positive cellular response was defined as an increase in the 5-bromo-2-deoxyuridine (BrdU) percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point on Days 22, 29, 43 or 57. All humoral responses were assessed by ELISA and all cellular responses were assessed by BrdU proliferation assay.|Baseline, Day 22, Day 29, Day 43 and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.|||participants|||Number
2566822|NCT02576145|Secondary|Number of Participants Who Developed a Positive Cellular Response to Tetanus Toxoid (TT)|Positive cellular response was defined as an increase in the BrdU percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point on days 22, 29, 43 or 57. All cellular responses were assessed by BrdU proliferation assay.|Baseline, Day 22, Day 29, Day 43 and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.|||participants|||Number
2566823|NCT02576145|Secondary|Number of Participants Who Developed a Positive Humoral Response to Tetanus Toxoid (TT)|Humoral response to TT was defined as >=1.5 fold increase in antibody concentration from baseline in participants with protective anti-TT IgG level >=0.1 IU/mL. All humoral responses were assessed by ELISA.|Baseline, Day 22, Day 29, Day 43 and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.|||participants|||Number
2566824|NCT02576145|Secondary|Number of Participants Who Developed Both a Positive Antibody Response and a Positive Cellular Response to KLH Immunization|Positive antibody response was defined as at least a 2-fold increase in antibody concentration on either Day 43 or Day 57 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. Positive cellular response was defined as an increase in the 5-bromo-2-deoxyuridine (BrdU) percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point on Days 22, 29, 43 or 57. All humoral responses were assessed by ELISA and all cellular responses were assessed by BrdU proliferation assay.|Baseline, Day 22, Day 29, Day 43 and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.|||participants|||Number
2566825|NCT02576145|Secondary|Number of Participants Who Developed a Positive Cellular Response to KLH Immunization|Positive cellular response was defined as an increase in the 5-bromo-2-deoxyuridine (BrdU) percent total net of at least 1.5-fold compared with baseline, where baseline was assigned a value of 0.5 if <=0, on at least one time point on Days 22, 29, 43 or 57. All cellular responses were assessed by BrdU proliferation assay.|Baseline, Day 22, Day 29, Day 43, and Day 57|All patient population: All participants who were enrolled in the study and received at least 1 vaccine dose were included in this population.|||participants|||Number
2566826|NCT02576145|Primary|Number of Participants Who Developed a Positive Antibody Response (IgG) to Keyhole Limpet Hemocyanin (KLH) Immunization|Positive antibody response was defined as at least a 2-fold increase in antibody concentration on either Day 43 or Day 57 compared with baseline where baseline was assigned a value of 1 if it was below the limit of quantification. All humoral responses were assessed by enzyme-linked immunosorbent assay (ELISA).|Baseline and Day 43 or Day 57|All patient population: All participants who were enrolled in the study and received at least 2 vaccine doses and had Day 43 and 57 assessments were included in this population.|||participants|||Number
2566827|NCT02576067|Secondary|Change in Max TBR Within the Carotid Arteries|Change in max target-to-background (TBR) - The mean of max TBR within the carotid arteries as an average of the slices from the left and right carotid)|baseline and 8 months||||ratio||Inter-Quartile Range|Median
2566828|NCT02576067|Secondary|Change in Max Target-to-background (TBR)|Change in max target-to-background (TBR) - The mean of max TBR within the carotid arteries as an average of the slices from the left and right carotid) at follow up imaging as compared to baseline.|baseline and 8 months||||ratio||Inter-Quartile Range|Median
2566829|NCT02576067|Primary|Change in Arterial Inflammation|Change in arterial inflammation - The relative change at 8 months as compared to baseline in arterial inflammation as measured by the most diseased segment (MDS) of the index vessel. The MDS is defined as the 1.5 cm segment within the carotid artery (right or left carotid) that demonstrates the highest PET/CT activity, and is calculated as a mean of maximum TBR values derived from 3 contiguous axial segments. The index vessel in turn is defined as the vessel (either aorta, right, or left carotid) with the greatest mean TBR at baseline. (MDS TBR Index Vessel)|baseline and 8 months||||percent change||Inter-Quartile Range|Median
2566830|NCT02576054|Secondary|Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 30 Months|Serum antibodies to HPV types were measured with a competitive luminex immunoassay. The serostatus cutoffs (mMU/mL) for HPV types were as follows: HPV Type 6: ≥20; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24.|24 months postdose 3 (30 months)|All participants that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 30 data within an acceptable date range of 24 months postdose 3.|||Percentage of Participants||95% Confidence Interval|Number
2566831|NCT02576054|Secondary|Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18: Persistence at 18 Months|Serum antibodies to HPV types were measured with a competitive luminex immunoassay. The serostatus cutoffs (mMU/mL) for HPV types were as follows: HPV Type 6: ≥20; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24|12 months postdose 3 (18 months)|All participants that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 18 data within an acceptable date range of 12 months postdose 3.|||Percentage of Participants||95% Confidence Interval|Number
2566936|NCT02573779|Secondary|Rates of Spontaneous Intestinal Perforation (SIP)|the number of patients who develop a spontaneous intestinal perforation will be collected|6-10 weeks||||Participants|||Count of Participants
2566833|NCT02576054|Secondary|Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18: Persistence at 18 Months|Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay. Antibody titers were expressed as mMU/mL.|12 months postdose 3 (18 months)|All participants that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 18 data within an acceptable date range of 12 months postdose 3.|||mMU/mL||95% Confidence Interval|Geometric Mean
2566834|NCT02576054|Secondary|Geometric Mean Titers for Serum Anti-HPV Types 6, 11, 16, and 18 Participants Aged 9 to 15 Years Versus Participants Aged 16 to 26 Years|Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay. Antibody titers were expressed mMU/mL. GMTs obtained for each anti-HPV from this study were compared to each of the ant-HPV GMTs obtained in study V501-122 (NCT NCT01862874) in which Japanese males 16 to 26 years received V501 in the same 3 dose regimen, to test a hypothesis that would demonstrate non-inferiority.|Four weeks postdose 3 (Month 7)|Participants 9 to 15 years old (PN200) or 16 to 26 years old (PN122) that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 7 serology result within 21 to 49 days post dose 3.|||mMU/mL||95% Confidence Interval|Geometric Mean
2566835|NCT02576054|Primary|Percentage of Participants With a Vaccine-related Serious Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The percentage of participants that experienced 1 or more SAEs that were considered at least possibly related to the study vaccine was summarized.|Up to 30 months|All participants who received at least 1 study vaccination and had follow-up safety data.|||Percentage of Participants|||Number
2566836|NCT02576054|Primary|Percentage of Participants With a Serious Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The percentage of participants that experienced 1 or more SAEs was summarized.|Up to Day 15 after any vaccination|All participants who received at least 1 study vaccination and had follow-up safety data.|||Percentage of Participants|||Number
2566837|NCT02576054|Primary|Percentage of Participants With a Systemic Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The parent/guardian of the participant was to record the presence of any VRC-prompted systemic AEs that occurred in the 5 days after any vaccination. The percentage of participants with a systemic AE was summarized.|Up to Day 15 after any vaccination|All participants who received at least 1 study vaccination and had follow-up safety data.|||Percentage of Participants|||Number
2566838|NCT02576054|Primary|Percentage of Participants With an Injection-site Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The parent/guardian of the participant was to record the presence of any vaccination report card (VRC)-prompted injection-site AEs that occurred in the 5 days after any vaccination. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.|Up to Day 5 after any vaccination|All participants who received at least 1 study vaccination and had follow-up safety data.|||Percentage of Participants|||Number
2566839|NCT02576054|Primary|Percentage of Participants With Elevated Oral Temperature (>=37.5° C)|The parent/guardian of the participant was to record the participant's oral temperature in the evening after each study vaccination and daily for 4 days after each study vaccination. Elevated temperature was defined as ≥99.5°F (≥37.5ºC). The percentage of participants that had an elevated temperature was summarized.|Up to Day 5 after any vaccination|All participants who received at least 1 study vaccination and had follow-up safety data.|||Percentage of Participants|||Number
2566840|NCT02576054|Primary|Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18|Antibodies to HPV Types 6, 11, 16, and 18 were measured using a competitive luminex immunoassay 4 weeks after 3rd vaccination (Month 7). Antibody titers were expressed as milli Merck units/mL (mMU/mL). Seroconversion was defined as an anti-HPV 6 titer ≥20 mMU/mL, an anti-HPV 11 titer ≥16 mMU/mL, an anti-HPV 16 titer of ≥20 mMU/mL and an anti-HPV 18 titer of ≥24 mMU/mL.|Four weeks postdose 3 (Month 7)|All participants that received all 3 vaccinations within acceptable day ranges, were seronegative to the relevant HPV type at Day 1, did not have protocol violations that could interfere with evaluation of the immune response, and provided Month 7 serology result within 21 to 49 days post dose 3.|||Percentage of Participants||95% Confidence Interval|Mean
2566841|NCT02576041|Secondary|Time to Reaction Evaluated During the F1 Simulator|During the test, at different times, the patient will be requested (by led enlighten on the dashboard) to execute actions on the steering-wheel. The delay in executing the requested actions will be registered.|7±3 days of active treatment|Adult outpatient of eighter sex affected by Allergic Rhinitis (seasonal or perennial) and/or chronic urticaria (induced or not induced) able to perform a preliminary driving test on F1-high speed simulator without experiencing sign or symptoms of intolerance towards the drive simulation (e.g. nausea, vomiting or dizziness).|||msec||Standard Deviation|Mean
2566842|NCT02576041|Secondary|Maintenance of Constant Speed Evaluated During the F1 Simulator|Different speed were maintained as requested by the simulator. Variations during the test were recorded. The mean deviation from the requested speed was registered.|7±3 days of active treatment|The study included adult outpatient of either sex,affected by Allergic Rhinitis (seasonal or perennial) and/or Chronic Urticaria (induced or not induced),able to perform a preliminary driving test on F1-high speed simulator without experiencing signs or symptoms of intolerance towards the drive simulation (e.g. nausea, vomiting or dizziness, etc).|||Km/h||Standard Deviation|Mean
2566843|NCT02576041|Primary|Standard Deviation Lateral Position (SDLP) Evaluated During the F1 Simulator Test|SDLP (mainly assessing attention capacities). This is a measure of weaving and quality in keeping the requested path. The vehicle position was constantly monitored. The deviation from central position was registered.|7+3 days of active treatment|The study included adult outpatient of either sex affected by allergic rhinitis (seasonal or perennial) and/or chronic urticaria (induced or not induced) able to perform a preliminary driving test on F1-high speed simulator without experiencing sign or symptoms of intolerance towards the drive simulation (e.g. nausea, vomiting or dizziness).|||meters||Standard Deviation|Mean
2566844|NCT02575950|Secondary|Number of Participants With Occurrence of Unacceptable LSR Scores or Unacceptable Safety and Tolerability Events at All Visits|"Unacceptable LSRs, safety and tolerability in an individual participant were defined as:~Clinically relevant signs or symptoms that in the opinion of the investigator were deemed unacceptable.~Occurrence of LSRs as specified below:~One of the following~Grade 4 crusting~Grade 4 erosion/ulceration~Grade 4 vesiculation/pustulation extending significantly outside treatment areas~Two of the following~Grade 4 erythema~Grade 3 crusting~Grade 4 swelling extending significantly outside treatment areas~Grade 3 erosion/ulceration~Grade 3 vesiculation/pustulation"|At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12||||Participants|||Count of Participants
2566845|NCT02575950|Secondary|Participant's Component LSR Score: Vesiculation/Pustulation|"The vesiculation/postulation score was determined according to the 5 point scale below.~0=not present~vesicles only~Transudate or pustulates with or without vesicles <50%~Transudate or pustulates, with or without vesicles >50%~Transudate or pustulates, with or without vesicles extending outside treatment area~4=Marked swelling extending outside treatment area"|At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12|6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.|||Participants|||Count of Participants
2566846|NCT02575950|Secondary|Participant's Component LSR Score: Swelling|"The swelling score was determined according to the 5 point scale below. 0=Not present~Slight, lesion specific oedema~Palpable oedema extending beyond individual lesions~Confluent and/or visible oedema~Marked swelling extending outside treatment area"|At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12|6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.|||Participants|||Count of Participants
2566847|NCT02575950|Secondary|Participant's Component LSR Score: Flaking/Scaling|"The flaking/scaling score was determined according to the 5 point scale below. 0=not present~Isolated scale, specific to lesion~Scale<50%~Scale>50%~Scaling extending outside treatment area"|At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12|6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.|||Participants|||Count of Participants
2566848|NCT02575950|Secondary|Participant's Component LSR Score: Erythema|"The erythema score was determined according to the 5 point scale below. Erythema 0=not present~slightly pink <50%~Pink or light red >50%~Red,restricted to treatment area~Red extending outside treatment area"|At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12|6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.|||Participants|||Count of Participants
2566849|NCT02575950|Secondary|Participant's Component LSR Score: Crusting|"The crusting score was determined according to the 5 point scale below.~0=not present~isolated crusting~Crusting<50%~Crusting>50%~Crusting extending outside treatment area"|At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12|6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.|||Participants|||Count of Participants
2566850|NCT02575950|Secondary|Participant's Component LSR Score: Erosion/Ulceration|"The Erosion/Ulceration score was determined according to the 5 point scale below.~0=not present~Lesion specific erosion~Erosion extending beyond individual lesions~Erosion >50%~Black eschar or ulceration"|At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12|6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.|||Participants|||Count of Participants
2566851|NCT02575950|Secondary|Composite Local Skin Response (LSR) Score at All Visits|"The Local Skin Responses consists of the following 6 components: erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR component is given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity. The composite LSR score (0-24) is the sum of the scores graded from 0 to 4 on all six individual LSR categories.~Please see following outcome measure descriptions on the grading scale for the individual components:~Erosion/ulceration: 6. Secondary outcome measure~Crusting: 7. Secondary outcome measure.~Erythema: 8. Secondary outcome measure.~Flaking/scaling: 9. Secondary outcome measure.~Swelling: 10. Secondary outcome measure.~Vesiculation/pustulation: 11. Secondary outcome measure."|At baseline (Day 1), Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12|6 participants did not complete the trial and 7 participants had one or more missing visits during the trial.|||score on a scale||Standard Deviation|Mean
2566866|NCT02575833|Secondary|Time to Onset of ≥ 1 mm ST-segment Depression|"Time to onset of ≥ 1 mm ST-segment depression was defined as the time the participant received study drug to the time of event onset during the exercise treadmill test. If no event occurred the participant was censored at the exercise treadmill test stop time.~Heart rate and rhythm were monitored during the exercise treadmill test by electrocardiography (ECG)."|Day 1|Participants who received study drug and completed the post-randomization exercise treadmill test.|||seconds||90% Confidence Interval|Median
2566867|NCT02575833|Secondary|Time to Onset of Exercise-induced Angina|Time to onset of angina was defined as the time the participant received study drug to the time of event onset during the exercise treadmill test. If no event occurred the participant was censored at the exercise treadmill test stop time.|Day 1|Participants who received study drug and completed the post-randomization exercise treadmill test|||seconds||90% Confidence Interval|Median
2566852|NCT02575950|Secondary|Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area|"The IGA score was determined according to the 5 point scale below.~0=Clear skin with no inflammatory and non-inflammatory lesions~Almost clear; rare non-inflammatory lesions with no more than one small inflammatory lesion~Mild severity; greater than Grade 1; some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions)~Moderate severity; greater than Grade 2; up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesions~Severe; greater than Grade 3; up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions"|At Week 12 (Day 84)|The analysis was based on the full analysis set (FAS). The FAS consisted of all participants except the first 2 participants included in Cohort 1 (according to protocol) were included in the FAS, thus the FAS comprised 38 participants. At Week 12, FAS comprised 32 participants as 6 participants discontinued before Week 12.|||Participants|||Count of Participants
2566853|NCT02575950|Secondary|Non-inflammatory Lesion Count|Count of non-inflammatory lesions in acne lesion areas|At Week 12 (Day 84)|The analysis was based on the full analysis set (FAS). The FAS consisted of all participants except the first 2 participants included in Cohort 1 (according to protocol) were included in the FAS, thus the FAS comprised 38 participants. At Week 12, FAS comprised 32 participants as 6 participants discontinued before Week 12.|||Lesions||Standard Deviation|Mean
2566854|NCT02575950|Secondary|Inflammatory Lesion Count|Count of inflammatory lesions in acne lesion areas|At Week 12 (Day 84)|The analysis was based on the full analysis set (FAS). The FAS consisted of all participants except the first 2 participants included in Cohort 1 (according to protocol) were included in the FAS, thus the FAS comprised 38 participants. At Week 12, FAS comprised 32 participants as 6 participants discontinued before Week 12.|||Lesions||Standard Deviation|Mean
2566855|NCT02575950|Primary|Total Lesion Count (Inflammatory and Non-inflammatory)|Total lesion count (inflammatory and non-inflammatory) in acne lesion areas.|At Week 12 (Day 84)|The analysis was based on the full analysis set (FAS). At Week 12, FAS comprised 32 subjects as 6 subjects discontinued before Week 12. The overall number of participants analyzed is irrespective of the number of participants providing data or not.|||Lesions||95% Confidence Interval|Least Squares Mean
2566856|NCT02575911|Secondary|Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op|Prediction error was summarized as a percentage of eyes within 0.5 D and 1.0 D of target at one and three months postoperative|Month 1, Month 3 postoperative|This analysis population includes the number of eyes treated with surgery and data available at the specified time point.|||percentage of eyes|Eyes||Number
2566857|NCT02575911|Secondary|Manifest Refraction Spherical Equivalent (MRSE)|The participant was manually refracted to his/her best correction using a phoropter and standard Snellen eye charts. Each eye contributed separately to the analysis.|Baseline, Month 1, Month 3 postoperative|This analysis population includes number of eyes in specified category.|||diopter|Eyes|Standard Deviation|Mean
2566858|NCT02575911|Secondary|Best Corrected Distance Visual Acuity (BCDVA) by Visit|BCDVA (measurement with the participant's best spectacle correction) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed.|Baseline, Month 1, Month 3 postoperative|This analysis population includes total number of eyes in specified category at visit.|||percentage of eyes|Eyes||Number
2566859|NCT02575911|Secondary|Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative|UCDVA (measurement of uncorrected (without spectacles or other visual corrective devices) distance visual acuity) was assessed at a distance of 6 meters or 20 feet using a standard Snellen eye chart, both monocularly and binocularly, and reported categorically as a percentage of eyes analyzed.|Month 1, Month 3 postoperative|This analysis population includes the number of eyes treated with surgery and data available.|||percentage of eyes|Eyes||Number
2566860|NCT02575911|Secondary|Opaque Bubble Layer (OBL) at Day 0, Operative Day|Opaque bubble layer was assessed by the investigator during the surgery on a scale from 0 to 5 where 0 = No OBL and 5 = 100% OBL in the stromal bed area. Each eye contributed separately to the analysis.|Day 0, operative day|Safety Analysis Set|||units on a scale|Eyes|Standard Deviation|Mean
2566861|NCT02575911|Secondary|Stromal Bed Quality at Day 0, Operative Day|Stromal bed quality was assessed by the investigator on a roughness scale from 0 to 5 where 0 = Very rough surface and 5 = Very smooth surface. Each eye contributed separately to the analysis.|Day 0, operative day|Safety Analysis Set|||units on a scale|Eyes|Standard Deviation|Mean
2566862|NCT02575911|Secondary|Ease of Flap Dissection at Day 0, Operative Day|Ease of flap dissection (ease of lifting the flap during surgery) was assessed on a scale from 0 to 5 where 0 = Unable to lift flap and 5 = Able to lift flap without any resistance using blunt instrument. Each eye contributed separately to the analysis.|Day 0, operative day|Safety Analysis Set|||units on a scale|Eyes|Standard Deviation|Mean
2566863|NCT02575911|Secondary|Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative|Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness precision (variability of the achieved flap thickness) was defined as the standard deviation of the flap thickness measurement. Each eye contributed separately to the analysis.|Month 1, Month 3 postoperative|This analysis population includes the number of eyes treated with surgery and data available.|||micrometers|Eyes|Standard Deviation|Mean
2566864|NCT02575911|Secondary|Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative|Flap thickness was assessed by OCT and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.|Month 1 postoperative|This analysis population includes the number of eyes treated with surgery and data available.|||micrometers|Eyes|Standard Deviation|Mean
2566865|NCT02575911|Primary|Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative|Flap thickness was assessed by optical coherence tomography (OCT) and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.|Month 3 postoperative|This analysis population includes the number of eyes treated with surgery and data available.|||micrometers|Eyes|Standard Deviation|Mean
2566868|NCT02575833|Primary|Change From Baseline in Total Exercise Time|"Total exercise time was assessed using an exercise treadmill test according to the standard Bruce protocol.~The Bruce protocol is a standardized multistage treadmill test for assessing cardiovascular health, where the participant walks on an uphill treadmill in a graded exercise test with electrodes on the chest to monitor cardiac function. Every 3 minutes, the speed and incline of the treadmill are increased. There are 7 such stages for a total possible exercise time of 21 minutes."|Baseline and day 1, after dosing|Participants who received study drug and completed the baseline and post-randomization exercise treadmill tests|||seconds||Standard Error|Least Squares Mean
2566869|NCT02575807|Primary|Phase 2: Progression Free Survival (PFS)|Number of weeks from the date of first dose of study treatment to the first date of objectively determined progressive disease (PD) or death from any cause, estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). PD is determined by mRECIST.|Subjects followed for disease progression from first dose of study treatment until 30 days after last dose of study treatment or initiation of new cancer treatment, whichever comes first, assessed up to 20 weeks.|Analysis performed on subjects in the Phase 2 SAF.|||weeks||95% Confidence Interval|Median
2566870|NCT02575807|Secondary|Overall Survival (OS)|Number of weeks from the date of first dose of study treatment to the date of death from any cause, estimated using KM methods with 95% CIs for subjects in the SAF. Subjects without documentation of death at the time of analysis were censored as of the date the subject was last known to be alive. For subjects lost to follow up, the last visit or last contact date where the subject is documented to be alive will be used to estimate last known date alive.|OS was assessed from the first dose of study treatment until death or study termination, whichever comes first, assessed up to 100 weeks.|Analysis performed on subjects in the Phase 1 and Phase 2 SAF.|||weeks||95% Confidence Interval|Median
2566871|NCT02575807|Secondary|Duration of Response (DOR)|Number of weeks from date of CR or PR designation until PD designation, as determined by mRECIST, RECIST v1.1 and GCIG CA-125 criteria.|Subjects followed for disease progression from date of CR or PR designation until documented disease progression or study termination, whichever comes first, assessed up to 100 weeks.|No study subjects achieved CR or PR designation; therefore, per the final SAP DOR was not derived.|||Participants|||Count of Participants
2566872|NCT02575807|Secondary|Disease Control Rate (DCR)|The protocol-specified DCR was defined as the percentage of evaluable subjects with a BOR of CR or PR, or SD as determined by mRECIST, RECIST v1.1, and GCIG CA-125 criteria.|BOR was assessed from the first dose of study treatment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever comes first, assessed up to 100 weeks.|Analysis performed on subjects in the Phase 1 and Phase 2 SAF.|||Participants|||Count of Participants
2566873|NCT02575807|Secondary|Phase 1: Progression Free Survival (PFS)|Number of weeks from the date of first dose of study treatment to the first date of objectively determined progressive disease (PD) or death due to any cause, estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). PD is determined by mRECIST, RECIST v1.1, and GCIG CA-125.|Subjects followed for disease progression from first dose of study treatment until 30 days after last dose of study treatment or initiation of new cancer treatment, whichever comes first, assessed up to 100 weeks|Analysis performed on subjects in the Phase 1 SAF.|||weeks||95% Confidence Interval|Median
2566874|NCT02575807|Secondary|Phase 1: Objective Response Rate (ORR) by mRECIST|ORR was evaluated for Phase 1 subjects based upon the best overall response (BOR) for individual study subjects. BOR was determined by the highest post-baseline qualitative response value for each assessed subject as measured by modified response evaluation criteria in solid tumors (mRECIST), RECIST v1.1, and GCIG CA-125 criteria and given the following hierarchy of overall response results: complete response (CR) > partial response (PR) > stable disease (SD) > progressive disease (PD) > not evaluable (NE). The protocol-specified ORR was defined as the percentage of evaluable subjects with a BOR of CR or PR; however, this percentage was not calculated per the final study Statistical Analysis Plan (SAP). Therefore, the number of evaluable subjects with BOR mRECIST values of CR, PR, SD, PD, and NE are provided for this outcome measure.|BOR was assessed from the first dose of study treatment until documented disease progression, starting of a new cancer treatment, death, or study termination, whichever is earlier, assessed up to 100 weeks.|Analysis performed on subjects in the SAF who had ≥1 post-baseline response assessment. Three subjects in the Phase 1 SAF did not complete ≥1 post-baseline response assessment and were therefore not evaluated for this outcome measure.|||Participants|||Count of Participants
2566875|NCT02575807|Primary|Phase 2: Objective Response Rate (ORR)|ORR was evaluated for Phase 2 subjects based upon the best overall response (BOR) for individual study subjects. BOR was determined by the highest post-baseline qualitative response value for each assessed subject as measured by modified response evaluation criteria in solid tumors (mRECIST) and given the following hierarchy of overall response results: complete response (CR) > partial response (PR) > stable disease (SD) > progressive disease (PD) > not evaluable (NE). The protocol-specified ORR was defined as the percentage of evaluable subjects with a BOR of CR or PR; however, this percentage was not calculated per the final study Statistical Analysis Plan (SAP). Therefore, the number of evaluable subjects with BOR mRECIST values of CR, PR, SD, PD, and NE are provided for this outcome measure.|BOR was assessed from the first dose of study treatment until documented disease progression, initiation of a new cancer treatment, death, or study termination, whichever comes first, assessed up to 20 weeks.|Analysis performed on subjects in the SAF who had ≥1 post-baseline response assessment. One subject in the Phase 2 SAF did not complete ≥1 post-baseline response assessment and was therefore not evaluated for this outcome measure.|||Participants|||Count of Participants
2566876|NCT02575807|Primary|Phase 2: Adverse Events (AEs)|Count of subjects in the Phase 2 cohorts with incidences of AEs.|Subjects followed from the start of study treatment until 30 days following the final dose of study drug, an average of 2 months.|Analysis performed on subjects in the Phase 2 safety analysis set.|||Participants|||Count of Participants
2566877|NCT02575807|Primary|Phase 1: Adverse Events (AEs) by CTCAE Grade 3 or Higher|Count of subjects in the Phase 1 cohorts with incidences of CTCAE Grade 3 or higher AEs.|Subjects followed from the start of study treatment until 30 days following the final dose of study drug, an average of 3 months.|Analysis performed on subjects in the Phase 1 safety analysis set.|||Participants|||Count of Participants
2566937|NCT02573779|Secondary|Rates of Necrotizing Enterocolitis (NEC)|the number of patients with a diagnosis of NEC (Stage ≥ IIA) will be collected|6-10 weeks||||Participants|||Count of Participants
2566878|NCT02575807|Primary|Phase 1: Number of Subjects Reporting Hematologic and/or Non-hematologic Dose-limiting Toxicity (DLT)|"Count of subjects in the Phase 1 cohorts who reported a hematologic and/or non-hematologic DLT. Non-hematological DLTs are defined as follows, excluding the safety events specified for exemption in Section 5.3.1 of the study protocol:~any treatment-emergent adverse event (TEAE) not attributable to disease or disease-related processes that occurs during the DLT observation period (Cycle 1) and is Grade 3 or higher according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4;~any use of systemic steroids; and/or~a study drug dose interruption lasting ≥ 7 days for an adverse event with an unclear relationship to study drug.~Hematological DLTs are defined as:~Grade 4 neutropenia lasting >7 days;~Grade ≥3 febrile neutropenia;~Grade 4 anemia;~Grade 4 thrombocytopenia or ≥ Grade 3 thrombocytopenia lasting >7 days or associated with bleeding; and/or~Dose delay >7 days secondary to myelosuppression."|Subjects followed for DLTs for 21 days following the first dose of CRS-207 (treatment Cycle 1 for CRS-207).|Analysis performed on subjects in the Phase 1 safety analysis set (SAF).|||Participants|||Count of Participants
2566879|NCT02575365|Secondary|the Correlation Between Effect of Fingolimod on Cognitive Performances and Brain Atrophy (Gray Matter Atrophy and Thalamic Atrophy) by Comparing Baseline and Month 24.|Correlation between effect of fingolimod on cognitive performances based on cognitive tests and brain atrophy based on MRI assessments will be explored.|baseline, month 24|The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted.||||||
2566880|NCT02575365|Secondary|Change From Baseline in Serum Levels of 24S-hydroxycholesterol (24OHC) , Osteopontin and Matrix Metalloproteinases (and Also MMPI's)|Serum samples will be collected at baseline and at months 6, 12 and 24 from each participant after evaluation for inclusion and exclusion criteria for measurement of 24 hydroxy cholesterol, osteopontin and matrix metalloproteinases (including MMPI's).|baseline, month 6, month , month 12 and month 24|The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted.||||||
2566881|NCT02575365|Secondary|Change From Baseline in Brain Gray Matter Atrophy and Thalamic Atrophy|MRI scans will be obtained by using 1,5T MRI for measuring gray matter atrophy and thalamic atrophy and a standard scanning protocol will be used for MRI in all centers.|baseline, month 6, month 12, month 18 and month 24|The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted.||||||
2566882|NCT02575365|Secondary|Change From Baseline in Stroop Test|The Stroop Color and Word Test assesses cognitive processing and provides valuable diagnostic information on brain dysfunction, cognition, and psychopathology|baseline, month 6, month 12 and month 24|The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted.||||||
2566883|NCT02575365|Secondary|Change From Baseline in PASAT Test|The Paced Auditory Serial Addition Test (PASAT) has been widely used in MS trials and it is considered to be a measure of sustained attention, divided attention, concentration, and information processing speed.|baseline ,months 6, month 12 and month 24|The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted.||||||
2566884|NCT02575365|Primary|Change From Baseline in The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) Battery Test at 24 Months|The Brief International Cognitive Assessment for MS (BICAMS Battery) includes 3 cognitive tests, 1-Symbol Digit Modalities Test (SDMT, 2-the second edition of the California Verbal Learning Test (CVLT2) and 3-the revised Brief Visuospatial Memory Test (BVMTR).|baseline and month 24|The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted.||||||
2566885|NCT02575365|Primary|Change From Baseline in The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) Battery Test at 12 Months|The Brief International Cognitive Assessment for MS ( BICAMS Battery ) includes 3 cognitive tests, 1-Symbol Digit Modalities Test (SDMT, 2-the second edition of the California Verbal Learning Test (CVLT2) and 3-the revised Brief Visuospatial Memory Test (BVMTR).|baseline , month 12.|The trial terminated early because there were only 4 patients who enrolled and only baseline visit was conducted.||||||
2566886|NCT02575300|Secondary|Duration of Response|Duration of response, defined as time from first observation of an objective response which is subsequently confirmed, to first disease progression or death due to any cause.|Up to 18 months|No participants experienced objective response||||||
2566887|NCT02575300|Secondary|Occurrence of Possibly Related Adverse Events (AEs)|Adverse events possibly related to study treatment with Ibrutinib. Safety and tolerability will be assessed according to the NIH/NCI Common TerminologyCriteria for Adverse Events version 4 (CTCAE v4).|Up to 18 months|All participants who received at least one dose of study drug and had at least one adverse event that was possibly probably or definitely related to study treatment.|||Participants|||Count of Participants
2566888|NCT02575300|Secondary|Overall Survival (OS)|Overall Survival determined from the time of drug administration to death from any cause.|Up to 24 months||||months||95% Confidence Interval|Median
2566889|NCT02575300|Secondary|Progression Free Survival (PFS)|Progression free survival at one year. PFS, determined as the time from administration of the initial dose of ibrutinib until objective tumor progression using RECIST, or death. Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm.|1 year||||months||95% Confidence Interval|Median
2566890|NCT02575300|Primary|Overall Radiographic Response Rate (ORR)|"Response rate as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. For this study, measurable disease is defined as the presence of at least one measurable lesion.~Measurable lesions must be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded) with a minimum size of: 10 mm by CT scan (CT scan slice thickness no greater than 5 mm (when CT scans have slice thickness >5 mm, the minimum size should be twice the slice thickness); 10 mm caliper measurement by clinical exam (lesions which cannot be accurately measured with calipers should be recorded as non-measurable); 20 mm by chest X-ray.~Complete Response (CR): complete disappearance of all target lesions, confirmed by repeat assessments at no less than 4 weeks after the criteria for response are first met. Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter."|Up to 18 months|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2567187|NCT02570074|Secondary|Elimination Half-life (t½)||Pooled over 24 hours at Day 1 and Day 5||||h||Standard Deviation|Mean
2566892|NCT02575079|Secondary|Death|Deaths from infection and death from any cause among participants in the parafilm study are reported.|Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)|Participants in the parafilm study are included in this analysis.|||Participants|||Count of Participants
2566893|NCT02575079|Secondary|Number of ICU Admissions Secondary to Sepsis|The cumulative number of ICU admissions secondary to sepsis among participants in the parafilm study is reported.|Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)|Participants in the parafilm study are included in this analysis.|||ICU admissions|||Number
2566894|NCT02575079|Secondary|Duration of Antibiotic Treatment Exposure|Total duration of antibiotic treatment exposure (excluding prophylactic antibiotics) among participants in the parafilm study will be reported.|Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)|Data on duration of antibiotic treatments were not collected.||||||
2566895|NCT02575079|Secondary|Number of Antibiotic Treatment Courses Per Participant|The number of antibiotic treatment courses per participant in the parafilm study will be recorded.|Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)|Data on antibiotic treatment courses were not collected.||||||
2566896|NCT02575079|Primary|Observed Outpatient Percentage of Catheter-days With Correctly Applied Parafilm|"For observed compliance, the outpatient nurse recorded whether the patient's parafilm was correctly applied/intact (yes), not applied (no), or incorrectly applied/not intact (yes-inc) at the beginning of the visit. The percentage of outpatient observed catheter-days where parafilm was correctly in use/intact was calculated."|Time between initial BMT discharge and either CVL removal or transfer back to primary MD (an expected average of 2-3 months)|Observed outpatient compliance was not performed as it was difficult to implement this in a busy clinic setting.||||||
2566897|NCT02575079|Primary|Reported Outpatient Percentage of Catheter-days With Correctly Applied Parafilm|For outpatient reported compliance, parents of study participants provided their logs to outpatient staff who documented the number of days parafilm was correctly in use/intact vs not in use or incorrectly in use/not intact. The cumulative percentage of catheter-days where parafilm was intact was calculated.|Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)|The population used for this analysis consists of caretakers who returned outpatient logs of parafilm use at the end of the study. Forty-one participants used parafilm in the outpatient setting and of these 34 returned the outpatient logs.|||percent of catheter-days|||Number
2566898|NCT02575079|Primary|Observed Inpatient Percentage of Catheter-days With Correctly Applied Parafilm|"Observed compliance occurred during weekly line rounds. Rounding providers indicated whether a patient's parafilm is intact and correctly applied, not applied, or incorrectly applied or not intact. The percentage of observed catheter-days where patients had correct use of intact parafilm were to be calculated. To track observed inpatient compliance with applying parafilm, data fields were added to the entered to the nursing charts of the participant's electronic medical record (EMR). The primary field added was a no/question about parafilm applied. Per study protocol, the intent was to document nursing changing of the parafilm, at the time it was changed. However, on reviewing the data, it appears that nursing just charted once per day whether they had changed parafilm or not, while the parafilm may have been changed earlier by a different nurse."|Time between initial bone marrow transplant (BMT) discharge and either central venous line (CVL) removal or transfer back to primary MD (an expected average of 2-3 months)|The data collected indicated that nursing staff did not understand how the parafilm monitoring needed to be charted for the purposes of data analysis. Although a data field was created in the EMR, in practice, the data collected was not an accurate assessment of parafilm use, thus no data are available for analysis of this outcome measure.||||||
2566899|NCT02575079|Primary|Reported Inpatient Percentage of Central-line Days With Correctly Applied Parafilm|In the inpatient setting, compliance was measured by once daily recording of parafilm change by nursing in the electronic medical record. These data were significantly limited by electronic medical record charting on parafilm change being required only once per day. Thus, once daily data collection failed to capture daily parafilm change, given multiple nursing shifts on a single calendar day. Nonetheless, the percentage of catheter-days with intact correctly applied parafilm, as reported by nursing staff, was calculated.|At discharge (an expected average of 6 weeks from admission)|Participants in the parafilm study are included in this analysis. Percentage of inpatient days where nursing charted parafilm change in the electronic medical record is reported for the entire parafilm cohort.|||percentage of central-line days|||Number
2566900|NCT02575079|Primary|Rate of Central Line Associated Bloodstream Infections (CLABSI)|Central line associated bloodstream infections (CLABSI) is the identification of a bacterial infection from a blood culture drawn from a central venous catheter (CVC) in the absence of a primary source of infection from another body site. The CLABSI rate (total number of CLABSI/1000 catheter-days) in parafilm study participants will be calculated and compared to the CLABSI rate in a historical cohort of pediatric patients who are serving as a control group.|Baseline (at the time of placement of the CVC or admission for HCT, whichever occurs later) to end of study (CVC removal or transfer back to primary service, whichever occurs sooner, average of 3 months)||||CLABSI/1000 catheter-days||95% Confidence Interval|Number
2566901|NCT02574858|Primary|Number of Subjects With Abnormal EKG|Review of EKG for abnormalities after intervention with QRH-882260. Paired EKGs will be reviewed for electrical changes post QRH-882260 ingestion.|30 minutes||||Participants|||Count of Participants
2566902|NCT02574858|Primary|Number of Subjects With Abnormal Lab Values|Review of laboratory values for abnormalities after intervention with QRH-882260. If the first post-procedure labs are outside normal range, they must be within 20% of the subject's baseline lab values or returning towards normal range. Lab values not meeting these criteria must be repeated weekly until they peak and weekly until normal or within 20% of baseline level or within normal range.|48 hours||||Participants|||Count of Participants
2566938|NCT02573779|Secondary|Days to Final Enteral Feed Volume|Number of days for infant to reach full enteral feeds.|6-10 weeks|Infants in both groups|||days||Standard Deviation|Mean
2566903|NCT02574845|Secondary|Area Under the Curve of Rosuvastatin From 0 Extrapolated to Infinity (AUC0-∞)|This outcome measure presents area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).|Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.||||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2566904|NCT02574845|Primary|Maximum Concentration of Rosuvastatin (Cmax)|This outcome measure presents the maximum measured concentration of rosuvastatin in plasma (Cmax).|Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.|PKS|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2566905|NCT02574845|Primary|Area Under the Curve of Rosuvastatin From 0 to the Last Quantifiable Data Point (AUC0-tz)|This outcome measure presents the area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).|Blood sampling within 3 hours (h) prior to the study drug administration, at the time of administration (0:00) and 30 minutes, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11h, 12h, 24h, 34h, and 48h thereafter.|The pharmacokinetic (PK) parameter set (PKS) includes all randomised subjects who took at least one dose of study medication and provided at least one primary or secondary PK parameter that was not excluded from analysis due to non-evaluability or protocol violation relevant for the evaluation of the pharmacokinetics.|||nanomol (nmol) * hour (h) / Litre (L)||Geometric Coefficient of Variation|Geometric Mean
2566906|NCT02574832|Primary|Time to T 10 Level|Elapsed time in minutes to achieve T 10 level of anesthesia. Assessed by the anesthesia care provider using crushed ice. T 10 level is numbness up to the level of the belly button.|20 minutes after drug administration||||Minutes||Full Range|Mean
2566907|NCT02574481|Secondary|6-Minute Walk Test - Speed|Change in speed walked from baseline to 12 months|Baseline to 12 months|Per PK sub-study design, secondary endpoint not analyzed.|||m/min||Standard Deviation|Mean
2566908|NCT02574481|Secondary|6-Minute Walk Test - Distance Walked|Change in distance walked from baseline to 12 months.|Change in baseline to 12-Months|Per PK sub-study design, secondary endpoint not analyzed.|||m||Standard Deviation|Mean
2566909|NCT02574481|Secondary|Walking Impairment Questionnaire (WIQ) Scores|The WIQ is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score. WIQ scores reported as change from baseline.|Baseline to 12 Months|Not all subjects were able to complete questionnaires.Per PK sub-study design, secondary endpoint not analyzed.|||Units on a scale||Standard Deviation|Mean
2566910|NCT02574481|Secondary|Number of Participants With Hemodynamic Improvement|Defined as an increase in the ankle-brachial index by greater than of equal to 0.10 compared with baseline or to an ankle-brachial index of greater than or equal to 0.90, without need for repeat target lesion revascularization.|12 Months|Per PK sub-study design, secondary endpoint not analyzed.|||Participants|||Count of Participants
2566911|NCT02574481|Secondary|Count of Participants Meeting Primary Sustained Clinical Improvement|Defined as improvement in Rutherford classification (defined as chronic, symptomatic lower limb ischemia in categories 2, 3 or 4) by one or more categories compared with baseline, without target lesion revascularization.|12 Months|Per PK sub-study design, secondary endpoint not analyzed.|||Participants|||Count of Participants
2566912|NCT02574481|Secondary|Number of CEC-adjudicated Events Through 12 Months|Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reach on (or beyond) the earliest visit window.|12 Months|Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reach on (or beyond) the earliest visit window.|||participants|||Number
2566913|NCT02574481|Primary|Number of Participants Reaching Primary Patency|Primary patency of target lesion at 12-months assessed by duplex ultrasound and adjudicated by an independent core laboratory|12 Months|Primary Patency: percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without clinically-driven TLR or, bypass of the target lesion before or on the DUS FU visit. Per PK sub-study design, primary efficacy (patency) not analyzed.|||Participants|||Count of Participants
2566914|NCT02574481|Primary|Percentage of Participants With Major Adverse Events (MAEs)|MAEs defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization (TLR) through 12 months|12 Months||||percentage of participants|||Number
2566915|NCT02574312|Secondary|Number of Participants With Treatment-related Adverse Events||3 Months Post Surgery|All subjects who received the study device|||Participants|||Number
2566916|NCT02574312|Secondary|Posterior Tibial Slope Between Subjects Operated on With RUI and SUI Instrumentation||3 Months Post Surgery|All patients with readable radiographs who were enrolled without major protocol violations|||Degrees|Radiographs|Standard Deviation|Mean
2566917|NCT02574312|Secondary|Femoral Component Flexion Angle Between Subjects Operated on With RUI and SUI Instrumentation||3 Months Post Surgery|All patients with readable radiographs who were enrolled without major protocol violations|||Degrees|Radiographs|Standard Deviation|Mean
2566918|NCT02574312|Secondary|Tibial Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation||3 Months Post Surgery|All patients with readable radiographs who were enrolled without major protocol violations|||Degrees|Radiographs|Standard Deviation|Mean
2566919|NCT02574312|Secondary|Femoral Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation||3 Months Post Surgery|All patients with readable radiographs who were enrolled without major protocol violations|||Degrees|Radiographs|Standard Deviation|Mean
2566920|NCT02574312|Primary|Difference in Absolute Mechanical Axis Alignment Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation||3 Months Post Surgery|All patients with readable radiographs who were enrolled without major protocol violations|||Degrees|Radiographs|Standard Deviation|Mean
2566921|NCT02574260|Secondary|Number of Participants Alive at the Time of Study Discontinuation or Completion||At end of study, median duration of treatment was 267 days||||participants|||Number
2567188|NCT02570074|Secondary|Elimination Rate Constant (z)||Pooled over 24 hours at Day 1 and Day 5||||1/h||Standard Deviation|Mean
2566922|NCT02574260|Secondary|Number of Participants With an Objective Response|"Objective response is defined as participants with an overall best response of complete response or partial response. The objective response to treatment was assessed by computed tomography (CT) scanning or other clinical measurement using modified Response Evaluation Criteria In Solid Tumors (RECIST).~Responses must have been confirmed two visits not less than 4 weeks apart.~Tumor burden for a visit was calculated as the sum of the longest diameters of all tumors identified and measured up to that visit. Tumor response at each visit was derived from tumor burden, as follows:~Complete response (CR): zero tumor burden~Partial response (PR): a 30% or greater decrease in tumor burden~Progressive disease (PD): a 20% or greater increase in tumor burden~Stable disease (SD): none of the above (a < 30% decrease and < 20% increase in tumor burden)"|Every 12 weeks from the start of therapy in this extension protocol, or 12 weeks from the last assessment in the 002/03 protocol (whichever date is later) through 30 days after administration of the last dose; median duration of treatment was 267 days.||||participants|||Number
2566923|NCT02574260|Primary|Number of Participants With Adverse Events|"The severity of an adverse event (AE) was graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 3 (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death).~Serious adverse events include death, life-threatening events, events requiring or prolonging hospitalization, result in persistent or significant disability/incapacity, or a congenital anomaly/birth defect, or otherwise important medical events that may jeopardise the patient or require intervention to prevent one of the above outcomes."|From the first dose of talimogene laherparepvec in Study 002-03-E and within 30 days of the last dose; median duration of treatment was 267 days.||||participants|||Number
2566924|NCT02574247|Post-Hoc|Association Between Medial Olivocochlear Reflex Inhibition and Slope of the Psychometric Function of Untrained Speech Perception Tasks|Partial Spearman rank correlation computed between medial olivocochlear reflex inhibition (in decibels) and slope of the psychometric function (in decibel per decibel) of untrained speech tasks (Coordinate Response Measure -- CRM; Institute of Electrical and Electronics Engineers -- IEEE) obtained from performance across two signal-to-noise ratios. Age and high-frequency pure-tone average were controlled for in this post-hoc analysis. Results obtained at first study visit.|Baseline (First study visit - 3 hour session)|In order to increase statistical power, the baseline results for medial olivocochlear reflex inhibition results and speech perception from the Training, Control, and Speech Groups were pooled for this analysis.|||Spearman partial rank correlation|||Number
2566925|NCT02574247|Secondary|Change in Auditory Training Phoneme Task Performance|Difference in signal-to-noise ratio (in decibels) on auditory training phoneme tasks (onsets, nuclei, and codas), computed between first and last measurement.|First and last measurements (baseline and last session up to a year later)|Due to the small sample size, statistical analyses of group data were not performed. Data were not collected in the Control or Speech groups.|||Signal-to-noise ratio change in decibels||Full Range|Median
2566926|NCT02574247|Secondary|Change in Auditory Training Sentence Task Performance|Difference in percent correct of auditory training sentences, computed between first and last measurements.|First and last measurements (baseline and last session up to a year later)|Due to the small sample size, statistical analyses of group data were not performed. Data were not collected in the Control or Speech groups.|||Difference in percentage correct||Full Range|Median
2566927|NCT02574247|Primary|Association Between Medial Olivocochlear Reflex Inhibition and Untrained Speech Perception Tasks|Spearman rank correlation computed between medial olivocochlear reflex inhibition (in decibels) and performance (in percent correct) on Coordinate Response Measure (CRM) task and Institute of Electrical and Electronics Engineers (IEEE) sentences, each presented at two decibel signal-to-noise ratios (dB SNR). Results obtained at first study visit.|Baseline (First study visit - 3 hour session)|In order to increase statistical power, the baseline results for medial olivocochlear reflex inhibition results and speech perception from the Training, Control, and Speech Groups were pooled for this analysis|||Spearman Rank Correlation Coefficient|||Number
2566928|NCT02574247|Primary|Change in Magnitude of Medial Olivocochlear Reflex Inhibition|Decibel difference in medial olivocochlear reflex inhibition computed between final visit and baseline visit, where medial olivocochlear reflex inhibition is quantified as amplitude difference (in decibels) between transient-evoked otoacoustic emissions obtained with versus without broadband noise presented to the contralateral ear.|First and last measurements (baseline and last session up to a year later)|Due to the small sample size in each group, statistical comparisons between groups were not performed. Data were not collected in the Speech Group.|||decibel difference||Full Range|Median
2566929|NCT02573948|Secondary|HIV Incidence|HIV incidence was calculated by 100person/year. With zero conversion, we choose 2.5% unilateral confidence interval.|52 weeks|HIV negative cohort participants with HCV test result available at W24 a/or W52|||infections per 100 person-years||2.5% Confidence Interval|Number
2566930|NCT02573948|Secondary|Incidence of HCV Infection|The HCV incidence was calculated by 100person/year|52 weeks|HCV negative cohort participants with HCV test result available at W24 a/or W52|||infections per 100 person-years||95% Confidence Interval|Number
2566931|NCT02573948|Secondary|HIV Seroconversion|Number of new HIV infection among HIV negative (at RDS) cohort participants over 1 year period.|52 weeks|HIV negative cohort participants with HIV test result available at W24 and/or W52.|||Participants|||Count of Participants
2566932|NCT02573948|Secondary|HCV Seroconversion|Number of new HCV infection among HCV negative (at RDS) cohort participants over 1 year period|52 weeks|HCV negative cohort participants with HCV test result available at W24 and/or W52.|||Participants|||Count of Participants
2566933|NCT02573948|Primary|Number of Cohort Participants Attending the Last Follow-up Visit at W52|Number of participants who were followed up and not lost to follow-up after enrolment into cohort.|52 weeks|Participants were invited to follow-up visits at W4, W12, W24 and W52|||Participants|||Count of Participants
2566934|NCT02573870|Primary|Change From Baseline in 0 to 4 Hours Post-dose Weighted Mean Heart Rate at Day 42, Derived From Electrocardiograms (ECGs)|ECG measurements were taken in supine position after obtaining vital signs. Weighted mean was derived by calculating the area under the curve (AUC), and then dividing by the relevant time interval. Baseline was the pre-dose measurement on Day 1. Change from Baseline in 0 to 4 hours post-dose weighted mean heart rate was measured on Days 1, 28 and 42 and was analyzed using a mixed models repeated measures (MMRM) model. Intent-To-Treat (ITT) Population: all randomized participants who received at least one dose of study medication.|Baseline and Day 42|ITT Population|||Beats per minute (bpm)||Standard Error|Least Squares Mean
2566943|NCT02573779|Primary|Intestinal Microbiome Diversity|Stool samples during the first 6 weeks of life will be analyzed to compare development of microbial diversity|6 weeks|Stool samples were selected for microbiota analysis from infants who had samples collected at every time point over the first 6 weeks of life (n=90).|||taxa represented||Standard Error|Mean
2566944|NCT02573467|Secondary|Number of Patients With Anti-BYM338 Antibodies|Investigated the development of immunogenicity against BYM338.|end of double-blind treatment (up to 8 months)|Safety set: The safety set consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension. Only those participants who provided a sample were analyzed.|||Participants|||Number
2566945|NCT02573467|Secondary|Change in Muscles of the Thigh|Magnetic resonance imaging (MRI) was planned to be used to characterize changes in muscles of the thigh in a subset of patients.|up to 1 year, up to 2 years|No participants were analyzed. The optional MRI assessment was not initiated as the study was stopped.||||||
2566946|NCT02573467|Secondary|Change From Core Study Baseline in Short Physical Performance Battery (SPPB) Score|The SPPB evaluated lower extremities function by testing gait speed, ability to keep standing balance and time to rise from a chair five times. The sub-score for each test ranged from 0 to 4. The summary score, which was a summation of scores from the 3 tests, ranged from 0 to 12. An increase in score indicates improvement in physical performance. A negative change from baseline indicates deterioration. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.|Core study baseline, week 52, week 78, week 104 and >=week 117|The full analysis set, which consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension, was considered for the analysis. Participants with both core baseline (BL) and post core-BL values for each time point were analyzed for that time point.|||score on a scale||Standard Deviation|Mean
2566947|NCT02573467|Secondary|Estimated Annual Number of Falls Per Participant Within Treatment Group|Participants documented any fall occurrences in a paper diary during the study.|Core baseline to end of extension double-blind treatment (up to a maximum of 32 months)|Safety set: The safety set consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension.|||Annual number of falls per participant|||Number
2566948|NCT02573467|Secondary|Change From Core Study Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score|Self-reported physical function was assessed by a newly developed patient reported outcome named sporadic inclusion body myositis (sIBM) functional assessment (sIFA). The sIFA consists of 11 items scored on an 11 point numerical rating scale from 0 (no difficulty) to 10 (unable to do) across 3 domains: upper body functioning, lower body functioning and general functioning. Participants completed the assessment where the recall period was the past week prior to completing the patient reported outcome (PRO). The total score on the sIFA scale ranges from 0 (minimum) to 110 (maximum). Higher values represent a worse outcome. A positive change from baseline indicates deterioration. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.|Core study baseline, week 52, week 78, week 104, and >=week 117|The full analysis set, which consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension, was considered for the analysis. Participants with both core baseline (BL) and post core-BL values for each time point were analyzed for that time point.|||score on a scale||Standard Deviation|Mean
2566949|NCT02573467|Secondary|Change From Core Study Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side|Quantitative Muscle Testing (QMT) was used to describe the long-term evolution of quadriceps muscle strength on the right side. The QMT was performed using the same portable fixed dynamometry (PFD) used in the core study. A negative change from baseline indicates deterioration. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.|Core study baseline, week 52, week 78, week 104 and >=week 117|The full analysis set, which consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension, was considered for the analysis. Participants with both core baseline (BL) and post core-BL values for each time point were analyzed for that time point.|||newtons||Standard Deviation|Mean
2566950|NCT02573467|Primary|Change From Core Study Baseline in 6 Minute Walking Distance Test (6MWD)|The 6MWD test measures the distance (in meters) that a participant can walk in a 6 minute time frame. A positive change from baseline indicates improvement. The efficacy analysis and time points were based on windowed visits relative to the first dose of the double-blind treatment in the core study.|Core study baseline, weeks 52, 78, 104, and >=117|The full analysis set, which consisted of all participants who were assigned to treatment in the core study and who received at least one dose of study drug during the extension, was considered for the analysis. Participants with both core baseline (BL) and post core-BL values for each time point were analyzed for that time point.|||meters||Standard Deviation|Mean
2566951|NCT02573467|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths.|Safety monitoring was conducted throughout the study. AEs starting on or after the day of first administration of extension study drug until last administration of study drug + 56 days are considered. SAEs starting on or after the day of first administration of extension study drug are considered. Deaths which occurred on or after the day of first administration of extension study drug are considered.|to end of study (up to 14 months, including the 6-month treatment-free follow-up period)|Safety set: The safety set consisted of all participants who received at least one dose of study drug during the extension study.|||Participants|||Number
2566952|NCT02573402|Secondary|Maximum Bladder Capacity as Evaluated by Urodynamic Study||2 weeks|One subject declined to repeat the post-TTNS urodynamic study, leaving 11 remaining in the TTNS group for the urodynamic measurements.|||mL||Standard Deviation|Mean
2566953|NCT02573402|Secondary|Maximum Bladder Capacity as Evaluated by Urodynamic Study||baseline||||mL||Standard Deviation|Mean
2566954|NCT02573402|Secondary|Maximum Detrusor Pressure as Evaluated by Urodynamic Study||2 weeks|One subject declined to repeat the post-TTNS urodynamic study, leaving 11 remaining in the TTNS group for the urodynamic measurements.|||cm H2O||Standard Deviation|Mean
2566955|NCT02573402|Secondary|Maximum Detrusor Pressure as Evaluated by Urodynamic Study||baseline||||cm H2O||Standard Deviation|Mean
2566956|NCT02573402|Primary|Mean Change in Pain Score as Indicated by Numeric Pain Scale (NPS)|"Participants received 30 minutes of TTNS (or sham stimulation) on each of 10 days over a 16-day period, and on each of the 10 days, pain was recorded immediately before stimulation (baseline) and at about 30 minutes later at the end of stimulation. For a single subject's mean change in pain score: [Average of the post-stimulation measurements for all 10 time points] minus [Average of baseline measurements for all 10 time points time point] = [mean change in pain score]. The value reported is the mean of all participants' mean change in pain score. The range of possible pain scores on the numeric pain scale is 1 to 10, with higher scores indicating higher level of pain."|baseline, about 30 minutes||||units on a scale||Standard Deviation|Mean
2566957|NCT02573402|Primary|Number of Participants Who Were Unexpectedly Discharged to an Acute Care Hospital||about 4 weeks||||Participants|||Count of Participants
2566958|NCT02573402|Primary|Number of Participants With Skin Irritation|Number of participants with skin irritation, which includes cellulitis, burn, or pressure injury. The one instance of skin irritation was pressure injury.|about 4 weeks||||Participants|||Count of Participants
2566959|NCT02573402|Primary|Number of Participants With Infection|All infections were urinary tract infections (UTIs).|about 4 weeks||||Participants|||Count of Participants
2566960|NCT02573311|Secondary|Percentage of Men Who Took Two or More Capsules Per Day Within the First 12/24 Weeks of Using Study Product Out of the Total Population in Cohort 1|Percentage of men who took two or more capsules per day within the first 12/24 weeks of using study product out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval|Week 12 and Week 24|FAS AU1|||Percentage of participants||95% Confidence Interval|Number
2566961|NCT02573311|Secondary|Percentage of Men Who Seek the Advice of a Physician Within the First 12/24 Weeks of the Study Out of the Total Population in Cohort 1|Percentage of men who sought advice of a physician within the first 12/24 weeks of the study out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval|Week 12 and Week 24|FAS AU1|||Percentage of participants||95% Confidence Interval|Number
2566962|NCT02573311|Secondary|"Percentage of Men Who Report at Baseline a Symptom or Condition Under the Ask A Doctor Before Use Section of the DFL and Initiate Contact With a Doctor Out of the Total Population of Cohort 1 Who Report a Symptom or Condition"|"Percentage of men who reported at baseline a symptom or condition under the Ask A Doctor Before Use section of the DFL and initiated contact with a doctor out of the total population of men in Cohort 1 who reported a symptom or condition is presented along with 95% exact two sided Clopper-Pearson confidence interval."|24 weeks|Full Analysis Set for Actual Use and Ask a Doctor Before Use (FAS-AU1-ASK) is a subset of the FAS-AU1 population which included all men who reported a symptom or condition listed under the “Ask a doctor before use” section of the DFL.|||Percentage of participants||95% Confidence Interval|Number
2566963|NCT02573311|Secondary|"Percentage of Men Who Report at Baseline a Symptom or Condition Under the Ask A Doctor Before Use Section of the DFL and Initiate Contact With a Doctor Out of the Total Population in Cohort 1"|"Percentage of men who reported at baseline a symptom or condition under the Ask A Doctor Before Use section of the DFL and initiated contact with a doctor out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval."|24 weeks|FAS AU1|||Percentage of participants||95% Confidence Interval|Number
2566964|NCT02573311|Secondary|"Percentage of Men Who Report a Condition Listed Under the Stop Use and Ask a Doctor if Section of the DFL Within the First 12 Weeks of Using Study Product Out of the Total Population in Cohort 1"|"Percentage of men who reported a condition listed under the Stop use and ask a doctor if section of the DFL within the first 12 weeks of using the study product out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval"|12 weeks|FAS AU1|||Percentage of participants||95% Confidence Interval|Number
2566965|NCT02573311|Secondary|"Percentage of Men Who Report Condition Listed Under Stop Use and Ask a Doctor if Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 24 Weeks"|"Percentage of men who reported a condition listed under the Stop use and ask a doctor if section of the DFL within 24 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 who reported a condition listed under the Stop use and ask a doctor if section of the DFL within 24 weeks of using study product is presented along with 95% exact two sided Clopper-Pearson confidence interval."|Week 24|Full Analysis Set for Actual Use and Stop Use and Ask If – Condition Within the First 24 Weeks: (FAS-AU1-COND24): These populations are subsets of the FAS-AU1 population which will include all men who report a condition listed under the “Stop use and ask a doctor if” section of DFL within the first 24 weeks of using the study product.|||Percentage of participants||95% Confidence Interval|Number
2566966|NCT02573311|Secondary|"Percentage of Men Who Report Condition Listed Under Stop Use and Ask a Doctor if Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 12 Weeks"|"Percentage of men who reported a condition listed under the Stop use and ask a doctor if section of the DFL within 12 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 who reported a condition listed under the Stop use and ask a doctor if section of the DFL within 12 weeks of using study product is presented along with 95% exact two sided Clopper-Pearson confidence interval."|Week 12|Full Analysis Set for Actual Use and Stop Use and Ask If – Condition Within the First 12 Weeks: (FAS-AU1-COND12): These populations are subsets of the FAS-AU1 population which will include all men who report a condition listed under the “Stop use and ask a doctor if” section of DFL within the first 12 weeks of using the study product.|||Percentage of participants||95% Confidence Interval|Number
2566967|NCT02573311|Secondary|"Percentage of Men Who Report a Condition Listed Under the Stop Use and Ask a Doctor if Section of the DFL During the Study (24 Weeks) and do Not Stop Use or Initiate Contact With a Doctor Out of the Total Population in Cohort 1"|"Percentage of men who reported a condition listed under the Stop use and ask a doctor if section of the DFL during the study (i.e., 24 weeks) and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval."|24 weeks|FAS AU1|||Percentage of participants||95% Confidence Interval|Number
2567189|NCT02570074|Secondary|Apparent Volume of Distribution (Vss)||Pooled over 24 hours at Day 1 and Day 5||||L||Standard Deviation|Mean
2566968|NCT02573311|Primary|"Percentage of Men Who Report a Condition Listed Under the Stop Use and Ask a Doctor if Section of the DFL Within the First 12 Weeks of Using Study Product and do Not Stop Use or Initiate Contact With Doctor Out of Total Population in Cohort 1"|"Percentage of men who reported a condition listed under the Stop use and ask a doctor if section of the Drug Facts Label (DFL) within the first 12 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population is presented along with 95% exact two sided Clopper-Pearson confidence interval."|12 weeks|Full Analysis Set for Actual Use (FAS-AU1) included all men who were currently not using a prescription medicine for BPH, purchased the study product, took at least one dose of study drug within the first 12 weeks of purchase and participated in at least 1 phone interview within the first 12 weeks of using the study product.|||Percentage of participants||95% Confidence Interval|Number
2566969|NCT02573233|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse event (AE) was defined as any untoward medical occurrence in a participant who received investigational medicinal product (IMP) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed or worsened or became serious during between the first administration of study medication to the end of the 12 week Post-treatment Period. Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included both serious and non-serious AEs.|Baseline up to Week 24|Analysis was performed on safety population which consisted of all participants randomized and exposed to study medication, regardless of the amount of treatment administered.|||Participants|||Count of Participants
2566970|NCT02573233|Secondary|Pharmacokinetics (PK) Assessment: Serum Functional Dupilumab Concentration|Serum functional dupilumab concentrations were determined using an enzyme-linked immunosorbent assay (ELISA) method.|Week 0, Week 2, 6, 8, 12, 18, End of study (Week 24)|"Analysis was performed on PK population which consisted of all participants with at least one non-missing and eligible post-baseline dupilumab serum concentration data. Data for this outcome measure was not planned to be analyzed for placebo arm. Here, number analyzed represents number of subjects with available data for specified time points."|||ng/mL||Standard Deviation|Mean
2566971|NCT02573233|Secondary|Number of Participants With Antidrug Antibodies (ADA)|Anti-drug antibodies were detected using a validated immunoassay. Incidence of ADA were classified as following: 1) Pre-existing immunoreactivity - an ADA positive response in the assay at baseline with all post treatment ADA results negative or an ADA positive response at baseline with all post treatment ADA responses less than 4-fold over baseline titer levels. 2) Treatment-emergent ADA: an ADA positive response in the assay post first dose, when baseline results were negative or missing. 3) Treatment-boosted ADA: an ADA positive response in the assay post first dose that was greater-than or equal to 4-fold over baseline titer levels, when baseline results were positive.|From Baseline up to 24 weeks|Analysis was performed on ADA population which consisted of all participants with at least one qualified ADA result in the ADA assay following the first dose of the study medication.|||Participants|||Count of Participants
2566972|NCT02573233|Secondary|Average Change in Fractional Exhaled Nitric Oxide (FeNO) From Baseline to Week 6 Through Week 12|"FeNO is a surrogate marker for airway inflammation. FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 mL/s, and reported in ppb.~The average change in FeNO from baseline to Week 6 through Week 12 was calculated as follows: For each participant the change in FeNO from Baseline to Week 6, Week 8, Week 10 and Week 12 was calculated (value at Week X - value at baseline). Subsequently the weekly mean of these 4 change from baseline values was determined (Weeks 6, 8, 10 and 12). Using these weekly mean values the overall arithmetic mean and standard deviation of the average change in FeNO from baseline to Week 6 through Week 12 was calculated."|From Baseline to Week 6 through Week 12|Analysis was performed on secondary PD population.|||ppb||Standard Deviation|Mean
2566973|NCT02573233|Secondary|Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 12|FeNO is a surrogate marker for airway inflammation. FeNO was analyzed using a NIOX instrument or similar analyzer using a flow rate of 50 mL/second, and reported in ppb.|Baseline, Week 12|Analysis was performed on secondary PD population which consisted of all randomized and treated participants. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||ppb||Standard Deviation|Mean
2566974|NCT02573233|Primary|Change From Baseline in T-Helper Lymphocytes Count in the Bronchial Submucosa at Week 12|T-helper i.e. CD4 positive lymphocytes were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.|Baseline, Week 12|Analysis was performed on PD population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||cells/mm^2||Inter-Quartile Range|Median
2566975|NCT02573233|Primary|Change From Baseline in T-Lymphocytes Count in the Bronchial Submucosa at Week 12|T-Lymphocytes i.e. CD3 positive cells were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.|Baseline, Week 12|Analysis was performed on PD population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||cells/mm^2||Inter-Quartile Range|Median
2566976|NCT02573233|Primary|Change From Baseline in Mast Cells Count (Tryptase Positive) in the Bronchial Submucosa at Week 12|Inflammatory cells i.e. mast cells were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.|Baseline, Week 12|Analysis was performed on PD population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||cells/mm^2||Standard Deviation|Mean
2566977|NCT02573233|Primary|Change From Baseline in Mast Cells Count (Chymase Positive) in the Bronchial Submucosa at Week 12|Inflammatory cells i.e. mast cells were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.|Baseline, Week 12|Analysis was performed on PD population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||cells/mm^2||Standard Deviation|Mean
2567190|NCT02570074|Secondary|Total Body Clearance (CL)||Pooled over 24 hours: Day 1||||L/h||Standard Deviation|Mean
2567191|NCT02570074|Primary|Number of Subjects Who Prematurely Discontinue Study Drug||Dosing period: 7 days||||Participants|||Count of Participants
2566978|NCT02573233|Primary|Change From Baseline in Mucin-Stained Area in the Bronchial Submucosa at Week 12|Mucin was identified by staining with Alcian-blue periodic acid-Schiff and/or immunostaining for MUC5AC and then the mucin-positive area was measured and expressed per square millimeter.|Baseline, Week 12|Analysis was performed on PD population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||cells/mm^2||Standard Deviation|Mean
2566979|NCT02573233|Primary|Change From Baseline in Eosinophils Cells Count in the Bronchial Submucosa at Week 12|Inflammatory cells i.e. eosinophils were counted in the bronchial submucosa of biopsy thin sections using quantitative immunohistochemistry and reported as the number of cells per square millimeter.|Baseline, Week 12|Analysis was performed on pharmacodynamic (PD) population which consisted of all randomized participants who underwent baseline and Week12/end of treatment (EOT) bronchoscopies and have adequate biopsies for analysis at both baseline and EOT. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||cells/mm^2||Inter-Quartile Range|Median
2566980|NCT02573181|Secondary|Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)|The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMTs of each pneumococcal serotype was calculated. Titer levels were determined with multiplexed OPA (MOPA-4).|Baseline (Day 1) and Day 30 after vaccination|Randomized and vaccinated participants with no protocol violations, and with data for both Day 1 and Day 30, are included.|||Percentage of Participants||95% Confidence Interval|Number
2566981|NCT02573181|Secondary|Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)|The GMFR (Day 30 GMT / Day 1 GMT) from baseline (Day 1) to Day 30 of each OPA serotype was calculated. Titer levels were determined with multiplexed OPA (MOPA-4).|Baseline (Day 1) and Day 30 after vaccination|Randomized and vaccinated participants with no protocol violations, and with data for both Day 1 and Day 30, are included.|||GMFR||95% Confidence Interval|Geometric Mean
2566982|NCT02573181|Secondary|Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA)|The OPA GMTs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Titer levels were determined with multiplexed OPA (MOPA-4).|Baseline (Day 1) and Day 30 after vaccination|Randomized and vaccinated participants with no protocol violations are included.|||Titers||95% Confidence Interval|Geometric Mean
2566983|NCT02573181|Primary|Percentage of Participants With ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)|The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMCs of each pneumococcal serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence.|Baseline (Day 1) and Day 30 after vaccination|Randomized and vaccinated participants with no protocol violations, and with data for both Day 1 and Day 30, are included.|||Percentage of Participants||95% Confidence Interval|Number
2566984|NCT02573181|Primary|Geometric Mean Fold Rise (GMFR) From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)|The GMFR (Day 30 geometric mean concentration [GMC] / Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated. Concentrations of each pneumococcal serotype were determined using pneumococcal electrochemiluminescence.|Baseline (Day 1) and Day 30 after vaccination|Randomized and vaccinated participants with no protocol violations, and with data for both Day 1 and Day 30, are included.|||GMFR||95% Confidence Interval|Geometric Mean
2566985|NCT02573181|Primary|Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG)|The IgG GMCs of each pneumococcal serotype were calculated on Day 1 (baseline) and Day 30 after vaccination. Concentrations were determined using pneumococcal electrochemiluminescence.|Baseline (Day 1) and Day 30 after vaccination|Randomized and vaccinated participants with no protocol violations are included.|||µg/mL||95% Confidence Interval|Geometric Mean
2566986|NCT02573181|Primary|Percentage of Participants With a Solicited Systemic Adverse Event (AE)|Solicited systemic AEs consisted of fatigue, arthralgia, myalgia, and headache.|Up to Day 14 after vaccination|All participants who received study vaccination are included.|||Percentage of Participants|||Number
2566987|NCT02573181|Primary|Percentage of Participants With a Solicited Injection-site Adverse Event (AE)|Solicited injection-site AEs consisted of erythema/redness, swelling, and pain/tenderness.|Up to Day 5 after vaccination|All participants who received study vaccination are included.|||Percentage of Participants|||Number
2566988|NCT02573181|Primary|Percentage of Participants With an Adverse Event (AE)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Day 44 after vaccination|All participants who received study vaccination are included.|||Percentage of Participants|||Number
2566989|NCT02573155|Other Pre-specified|Elimination Half-life of AZD8871 in Parts 1 and 2|Elimination half-life (t½λz) for AZD8871 on Day 1 of each treatment period. t½λz was generally calculated over a period of less than 3 times the resultant half-life|Predose, and 5 min, 15 min, 30 min, and 45 min, at 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h and 36 h (Day 2) post-dose|Pharmacokinetic population: defined as all randomised subjects who have received at least 1 dose of investigational product in at least 1 treatment period and have evaluable PK parameters. AZD8871 plasma PK assessed following dosing with AZD8871 only (not placebo, indacaterol, or tiotropium).|||Hours||Standard Deviation|Mean
2566990|NCT02573155|Other Pre-specified|AUC of AZD8871 in Parts 1 and 2|AUC (area under the concentration-time curve from time 0 to infinity) of AZD8871 on Day 1 of each treatment period|Predose, and 5 min, 15 min, 30 min, and 45 min, at 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h and 36 h (Day 2) post-dose|Pharmacokinetic population: defined as all randomised subjects who have received at least 1 dose of investigational product in at least 1 treatment period and have evaluable PK parameters. AZD8871 plasma PK assessed following dosing with AZD8871 only (not placebo, indacaterol, or tiotropium).|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2567033|NCT02572817|Secondary|Incidence of New ARDS During the Study|Incidence of new ARDS during the study among those participants without ARDS at randomization|From Day 0 to Day 28|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment, further subset to those participants without ARDS at randomization.|||Participants|||Count of Participants
2566991|NCT02573155|Secondary|AUC(0-24) of AZD8871 in Parts 1 and 2|AUC(0-24) (area under the concentration-time curve from zero to 24h) of AZD8871 on Day 1 of each treatment period.|Pre-dose, and 5 min, 15 min, 30 min, 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h, and 36 h (Day 2) post-dose|Pharmacokinetic population: defined as all randomised subjects who have received at least 1 dose of investigational product in at least 1 treatment period and have evaluable PK parameters. AZD8871 plasma PK assessed following dosing with AZD8871 only (not placebo, indacaterol, or tiotropium).|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2566992|NCT02573155|Secondary|AUC(0-t) of AZD8871 in Parts 1 and 2|AUC(0-t) (area under the concentration-time curve from time zero to time of the last quantifiable measurable concentration) of AZD8871 on Day 1 of each treatment period.|Pre-dose, and 5 min, 15 min, 30 min, 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h, and 36 h (Day 2) post-dose|Pharmacokinetic population: defined as all randomised subjects who have received at least 1 dose of investigational product in at least 1 treatment period and have evaluable PK parameters. AZD8871 plasma PK assessed following dosing with AZD8871 only (not placebo, indacaterol, or tiotropium).|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2566993|NCT02573155|Secondary|Tmax of AZD8871 in Parts 1 and 2|tmax (time to reach maximum concentration) of AZD8871 on Day 1 of each treatment period.|Pre-dose, and 5 min, 15 min, 30 min, 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h, and 36 h (Day 2) post-dose|Pharmacokinetic population: defined as all randomised subjects who have received at least 1 dose of investigational product in at least 1 treatment period and have evaluable PK parameters. AZD8871 plasma PK assessed following dosing with AZD8871 only (not placebo, indacaterol, or tiotropium).|||Hours||Full Range|Median
2566994|NCT02573155|Secondary|Cmax of AZD8871 in Parts 1 and 2|Cmax (maximum observed plasma drug concentrations) of AZD8871 on Day 1 of each treatment period.|Pre-dose, and 5 min, 15 min, 30 min, 45 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h (Day 1), 24 h, and 36 h (Day 2) post-dose|Pharmacokinetic population: defined as all randomised subjects who have received at least 1 dose of investigational product in at least 1 treatment period and have evaluable PK parameters. AZD8871 plasma PK assessed following dosing with AZD8871 only (not placebo, indacaterol, or tiotropium).|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2566995|NCT02573155|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 2|Pharmacodynamics of AZD8871 before (-45 min and -15 min pre-dose) and after single dosing of AZD8871 Forced expiratory volume in 1 second (FEV1) on Day 2 (defined as the average of the values 23:00 and 24:00 hours after the morning dose of investigational product)|Baseline (Day 1) to 36 hours post-dose (Day 2)|The PP population is defined as all randomised subjects who satisfied the main I/E criteria, received IP, completed at least 1 treatment period, and did not present major violations to the protocol|||Liters||Standard Deviation|Mean
2566996|NCT02573155|Primary|Number of Participants With Clinically Relevant Abnormalities in Clinical Biochemistry, Hematology and Urinalysis|"A composite of clinically relevant abnormalities in clinical biochemistry, hematology and urinalysis laboratory evaluations. Laboratory tests (haematology, blood chemistry, and urinalysis) were performed at screening, at Day -1 (Part 1 only), at 24 hours (Day 2) and at follow-up (7 [±2] days) after IP administration. Coagulation was only performed at screening; TSH, T4 only at screening, at Day-1 and at follow-up.~Abnormal findings were flagged to the principal investigator who assessed clinical relevance based on medical criteria at individual subject level. Clinically relevant findings were assessed until the abnormality was considered non-clinically relevant."|From the time of informed consent up to 7 days after the last dose of IP.|Safety population: all randomized subjects who received at least 1 dose of the investigational product|||Participants|||Count of Participants
2566997|NCT02573155|Primary|Number of Participants With Clinically Relevant Abnormalities in Electrocardiograms (HR, QTcF and Other ECG Parameters).|"HR, QTcF and other ECG abnormalities were assessed by local digital 12-lead ECG performed in triplicate at the time points indicated:~ECG (Parts 1 and 2) was assessed at Screening, Day 1 baseline, 10 min, 30 min, 1 hour (h), 2 h, 3 h, 4 h, 8 h, 12 h, 24 h, 36 h after dosing.~Telemetry (Part 1), assessed with at least 2 lead real time display, was recorded at Day -1 (4-6 hours continuous recording, at the time this was more convenient for the logistics of the unit) and on Day 1 from the time of the IP administration up to at least 24 hours, but if advised by the Investigator or designee, then up to 36 hours after IP administration.~Abnormal findings were flagged to the principal investigator who assessed clinical relevance based on medical criteria at individual subject level. Clinically relevant findings were assessed until the abnormality was considered non-clinically relevant."|From the time of informed consent up to 36 hours after last dose of IP.|Safety population: all randomized subjects who received at least 1 dose of the investigational product|||Participants|||Count of Participants
2566998|NCT02573155|Primary|Number of Participants With Clinically Relevant Abnormalities in Blood Pressure|"Blood pressure (BP) measurements (diastolic [DBP] and systolic BP [SBP]) taken after ~5 minutes rest in supine position, at screening, baseline (≤1 hour before IP administration), 10 and 30 minutes, 1, 2, 3, 4, 8, 12 hours (Day 1) and 24 and 36 hours (Day 2) after IP administration. Normal BP at screening: SBP 100-140 mmHg (subjects aged ≤59 years) and 100-150 mmHg (subjects aged ≥60 years), and DBP 40-90 mmHg.~Criteria for notable changes in BP:~High SBP: (≥180 and increase over baseline (predose) ≥20) or (≥200 and baseline <200) Low SBP: (≤ 90 and decrease over baseline ≥20) or (≤75 and baseline >75) High DBP: (≥105 and increase over baseline ≥15) or (≥115 and baseline <115) Low DBP: (≤50 and decrease over baseline ≥15) or (≤40 and baseline >40) All out of range values were flagged to the principal investigator who assessed clinical relevance based on medical criteria at individual subject level. Clinically relevant findings were assessed until considered non-clinically relevant."|From the time of informed consent up to 36 hours after last dose of IP.|Safety population: all randomized subjects who received at least 1 dose of the investigational product|||Participants|||Count of Participants
2567013|NCT02573012|Secondary|Cumulative Prednisone Exposure (Dose)|"In Post-randomization prednisone arm, Cumulative dose = (number of capsules taken during week 1 to 4 * 1 mg) + (3/4 * number of capsules taken during week 5 to 8 * 1 mg) + (1/2 * number of capsules taken during week 9 to 12 * 1 mg) + (1/4 * number of capsules taken during week 13 to 16 * 1 mg). In continued arm, cumulative dose = (1/4 * number of capsule taken * 5 mg).~Cumulative prednisone dose is defined as cumulative blinded prednisone + cumulative flare rescue prednisone."|Randomization to 24 weeks|Safety Population. The cumulative flare rescue prednisone dose population is based upon the number of participants who required rescue treatment.|||mg||Standard Deviation|Mean
2566999|NCT02573155|Primary|The Number of Participants With Mild Persistent Asthma (Part 1) and COPD (Part 2) With at Least 1 Treatment-emergent Adverse Event|An adverse event is the development of an undesirable medical condition, or the deterioration of a pre-existing medical condition, following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition can be symptoms, signs, or the abnormal results of laboratory parameters (haematology, blood chemistry, urinalysis, physical examination, 12-lead ECGs and telemetry, and vital signs). AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 18.1.|From the time of informed consent up to 14 (±2) days after the last dose of investigational product. Unresolved AEs were followed up by the investigator for as long as medically indicated.|Safety population: all randomized subjects who received at least 1 dose of the investigational product.|||Participants|||Count of Participants
2567000|NCT02573012|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 24|The SDAI is the numerical sum of 5 outcome parameters: tender and swollen joint count based on a 28-joint assessment, patient and physician global assessment of disease activity according to 100-mm visual analog scale (VAS) and level of C-reactive protein in milligrams per deciliter (mg/dL, normal <1 mg/dl). The total SDAI score range is 0-86, where higher scores indicate increased disease activity. A positive change in score indicates worsening, and a negative change indicates improvement.|Randomization to Week 24||||Score on a scale||95% Confidence Interval|Least Squares Mean
2567001|NCT02573012|Secondary|Changes From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Score|The WPAI:SHP is a 6-item questionnaire to measure performance impairment of work and regular daily activity and yields 4 types of scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (WI) (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Total score and each score range from 0 (not affected/no impairment) to 100 (completely affected/impaired). Higher scores indicate greater impairment and less productivity. A positive change in score indicates impairment, and a negative change indicates improvement.|Baseline and Week 24|Intent to Treat population.|||Score on a scale||Standard Deviation|Mean
2567002|NCT02573012|Secondary|Changes From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Final Score|The RAID is a participant-completed questionnaire specific for RA consisting of a 0-10 rating for pain, functional disability, fatigue, sleep, physical well-being, emotional well-being and coping. Scores are weighted to produce a final numerical result. A positive change in score indicates worsening, and a negative change indicates improvement.|Baseline and Week 24||||Score on a scale||Standard Deviation|Mean
2567003|NCT02573012|Secondary|Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Erythrocyte Sedimentation Rate (ESR)|Change from baseline in the acute phase reactant ESR|Baseline to Week 24||||mm/hr||Standard Deviation|Mean
2567004|NCT02573012|Secondary|Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: High Sensitivity C-Reactive Protein (hsCRP)|Change from baseline in the acute phase reactant hsCRP|Baseline to Week 24||||mg/dL||Standard Deviation|Mean
2567005|NCT02573012|Secondary|Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Health Assessment Questionnaire-Disability Index (HAQ-DI)|A measure of self-perceived disability containing 20 questions in eight categories and including additional section about aid from other people and devices needed to correct the disabilities. Scores range from 0 to 3, with higher scores indicating worse disability.|Baseline to Week 24||||Score on a scale||Standard Deviation|Mean
2567006|NCT02573012|Secondary|Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Physician's Global Assessment of Disease Activity|The ACR physician's global assessment of disease activity is scored on a visual analog scale (VAS) from 0 (symptom-free and no arthritis symptoms) to 100 mm (maximum arthritis disease activity). A positive change in score indicates worsening, and a negative change indicates improvement.|Baseline to Week 24||||cm||Standard Deviation|Mean
2567007|NCT02573012|Secondary|Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Patient's Global Assessment of Disease Activity|The ACR patient's global assessment of disease activity is scored on a visual analog scale (VAS) from 0 (symptom-free and no arthritis symptoms) to 100 mm (maximum arthritis disease activity). A positive change in score indicates worsening, and a negative change indicates improvement.|Baseline to Week 24||||cm||Standard Deviation|Mean
2567008|NCT02573012|Secondary|Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Patient's Assessment of Pain|The ACR patient's assessment of pain is scored on a visual analog scale (VAS) from 0 (no pain) to 100 mm (unbearable pain). A positive change in score indicates worsening, and a negative change indicates improvement.|Baseline to Week 24||||mm||Standard Deviation|Mean
2567009|NCT02573012|Secondary|Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Tender 68 Joint Counts|Count of tender joints based on 68 assessed joints.|Baseline to Week 24||||Tender joints||Standard Deviation|Mean
2567010|NCT02573012|Secondary|Changes From Baseline in American College of Rheumatology (ACR) Core Set Components at Week 24: Swollen 66 Joint Counts|Count of swollen joints based upon 66 assessed joints.|Baseline to Week 24||||Swollen joints||Standard Deviation|Mean
2567011|NCT02573012|Secondary|Percentage of Participants Who Permanently Discontinue Study Treatment Due to Insufficient Flare Control|Percentage of participants who permanently discontinue study treatment due to insufficient flare control|24 weeks||||Percentage of Participants|||Number
2567012|NCT02573012|Secondary|Percentage of Participants Who Maintain LDA (DAS28 ESR Score <=3.2) or Remission (DAS28 ESR Score <2.6) and the Percentage of Participants Who Maintain the Baseline Disease Activity Level|"The proportion of participants who maintained LDA and the proportion of participants who maintained the baseline disease activity level at Week 24.~LDA was defined as DAS28 ESR score <= 3.2. Remission was defined as DAS28 ESR score <= 2.6. Participants who maintained the baseline activity was defined as DAS28-ESR at Week 24 <= DAS28-ESR at baseline."|Randomization to Week 24|Intent to Treat population. The number of participants for LDA at Week 24 and Remission at Week 24 are based upon the number with LDA at baseline and DAS28-ESR ≤ 2.6 at baseline respectively.|||Percentage of Participants|||Number
2567020|NCT02573012|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index is calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter (cm) visual analog scale (VAS) + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 100 mm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores range from 0 to 76, with higher scores indicating increased disease activity. A positive change in score indicates worsening, and a negative change indicates improvement.|Baseline and Week 24||||Score on a scale||95% Confidence Interval|Least Squares Mean
2567021|NCT02573012|Secondary|Treatment Success|Treatment success was defined as the percentage of participants with stable low disease activity (LDA) (DAS28-ESR score ≤ 3.2) at Week 24 post-randomization, who did not suffer a flare due to RA and who showed no confirmed adrenal insufficiency that required replacement therapy. DAS28 has the following standardized cut-offs for disease activity and remission: DAS28 > 5.1 = high disease activity; DAS28 between 3.2 and 5.1 = moderate disease activity; DAS28 ≤ 3.2 = low disease activity; DAS28 ≤ 2.6 = remission.|Week 24||||Percentage of Participants||95% Confidence Interval|Number
2567022|NCT02573012|Primary|Change From Baseline in Disease Activity Score in 28 Joints - Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 24 Post-randomization|The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint count, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100-millimeter (mm) visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A positive change in score indicates worsening, and a negative change indicates improvement.|Baseline to Week 24||||Score on a scale||95% Confidence Interval|Least Squares Mean
2567023|NCT02572817|Secondary|Number of Participants With Serious Adverse Events (SAEs).|Number of participants with reported serious adverse events (SAEs) throughout the study duration.|From Day 0 to Day 28|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment.|||Participants|||Count of Participants
2567024|NCT02572817|Secondary|Number of Participants With Grade 3 and 4 Adverse Events (AEs).|Number of participants with reported grade 3 and 4 adverse events (AEs) throughout the study duration. In cases where participants had multiple reports of grade 3 and 4 AEs, they were only counted once.|From Day 0 to Day 28|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment.|||Participants|||Count of Participants
2567025|NCT02572817|Secondary|Hemagglutination Inhibition Assay (HAI) Titers at Days 1, 3, 7 for A/HongKong/4801/2014 H3N2|Hemagglutination inhibition assay (HAI) titers as measured by serial dilutions at Days 1, 3, 7 for A/HongKong/4801/2014 H3N2. HAI for A/HongKong/4801/2014 H3N2 was tested in all influenza seasons while the study was ongoing.|Day 1, Day 3, Day 7|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment|||ratios||95% Confidence Interval|Geometric Mean
2567026|NCT02572817|Secondary|Hemagglutination Inhibition Assay (HAI) Titers at Days 1, 3, 7 for A/H1N1|Hemagglutination inhibition assay (HAI) titers as measured by serial dilutions at Days 1, 3, 7 for A/H1N1. HAI for A/H1N1 was tested in all influenza seasons while the study was ongoing.|Day 1, Day 3, Day 7|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment|||ratios||95% Confidence Interval|Geometric Mean
2567027|NCT02572817|Secondary|Detectable Influenza Virus at Day 3|Detectable influenza virus at Day 3 in oropharyngeal samples|Day 3|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment. This group was further subset wo those with available OP sample results at Day 3.|||Participants|||Count of Participants
2567028|NCT02572817|Secondary|Disposition After Initial Hospitalization|"Disposition at discharge after initial hospitalization was categorized as follows:~Death, Ongoing at 28 days, Chronic nursing facility, Rehabilitation, Home with home health care, Home without assistance.~The number of deaths at discharge after initial hospitalization do not necessarily match the overall number of deaths."|From Day 0 to Day 28|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment|||Participants|||Count of Participants
2567029|NCT02572817|Secondary|Change From Baseline to Day 3 and Day 7 in Pediatric Logistic Organ Dysfunction (PELOD) Score|"The Pediatric Logistic Organ Dysfunction (PELOD) score was only measured for the pediatric participants.~The range is from 0 to 71, with lower values representing a better outcome. Baseline is defined as the Day 0. Change was defined as the value at Day 3 or Day 7 minus the value at baseline."|Day 0, Day 3, Day 7|Modified intent-to-treat pediatric population: subgroup of randomized pediatric participants who received any study treatment|||units on a scale||Inter-Quartile Range|Median
2567030|NCT02572817|Secondary|Change From Baseline to Day 3 and Day 7 in Sequential Organ Failure Assessment (SOFA) Score|"The Sequential Organ Failure Assessment (SOFA) score was only measured for the adult participants.~The range is from 0 to 24, with lower values representing a better outcome. Baseline is defined as the Day 0. Change was defined as the value at Day 3 or Day 7 minus the value at baseline."|Day 0, Day 3, Day 7|Modified intent-to-treat adult population: subgroup of randomized adult participants who received any study treatment.|||units on a scale||Inter-Quartile Range|Median
2567031|NCT02572817|Secondary|Incidence of New ECMO Use During the Study|Incidence of new ECMO use during the study among those participants not on ECMO at randomization|From Day 0 to Day 28|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment, further subset to those participants who were not on ECMO at randomization.|||Participants|||Count of Participants
2567032|NCT02572817|Secondary|Duration of Extracorporeal Membrane Oxygenation (ECMO)|"Duration (in days) of ECMO use among those participants on ECMO at randomization.~The duration is restricted to duration between randomization and last visit."|From Day 0 to Day 28|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment, further subset to those participants who were on ECMO at randomization.|||days||Inter-Quartile Range|Median
2567034|NCT02572817|Secondary|Duration of Acute Respiratory Distress Syndrome (ARDS)|"Duration (in days) of ARDS use among those participants with ARDS at randomization.~The duration is restricted to duration between randomization and last visit."|From Day 0 to Day 28|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment, further subset to those participants with ARDS at randomization.|||days||Inter-Quartile Range|Median
2567035|NCT02572817|Secondary|Incidence of New Mechanical Ventilation Use Stay Use During the Study|Incidence of new mechanical ventilation use during the study among those participants who were not on mechanical ventilation at randomization|From Day 0 to Day 28|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment, further subset to those participants who were not on mechanical ventilation at randomization.|||Participants|||Count of Participants
2567036|NCT02572817|Secondary|Duration of Mechanical Ventilation Use|"Duration (in days) of mechanical ventilation use among those participants who were on mechanical ventilation at randomization.~The duration is restricted to duration between randomization and last visit."|From Day 0 to Day 28 visit. The window of the Day 28 visit was 28-32 days from study entry|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment, further subset to those participants who were on mechanical ventilation at randomization.|||days||Inter-Quartile Range|Median
2567037|NCT02572817|Secondary|Incidence of New ICU Admission Use During the Study|Incidence of new ICU admission during the study among those participants who were not in ICU at randomization|From Day 0 to Day 28|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment, further subset to those participants who were not in the ICU at randomization.|||Participants|||Count of Participants
2567038|NCT02572817|Secondary|Duration of Intensive Care Unit (ICU) Stay|"Duration (in days) of ICU stay among those participants who were in ICU at randomization.~The duration is restricted to duration between randomization and last visit."|From Day 0 to Day 28|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment, further subset to those participants who were in the ICU at randomization.|||days||Inter-Quartile Range|Median
2567039|NCT02572817|Secondary|Incidence of New Oxygen Use During the Study|Incidence of new oxygen use during the study among those participants who did not require oxygen at randomization|From Day 0 to Day 28|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment, further subset to those participants who did not require oxygen at randomization.|||Participants|||Count of Participants
2567040|NCT02572817|Secondary|Duration of Supplemental Oxygen|"Duration (in days) of total supplemental oxygen use among those participants who required new or increased oxygen at randomization.~The duration is restricted to duration between randomization and last visit."|From Day 0 to Day 28 visit. The window of the Day 28 visit was 28-32 days from study entry.|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment, further subset to those participants who required new or increased oxygen at randomization.|||days||Inter-Quartile Range|Median
2567041|NCT02572817|Secondary|Change From Baseline to Day 3 and Day 7 in Pediatric Early Warning (PEW) Score|"The Pediatric Early Warning (PEW) score was only measured for the pediatric participants.~The range is from 0 to 26, with lower values representing a better outcome. Baseline is defined as the Day 0. Change was defined as the value at Day 3 or Day 7 minus the value at baseline."|Day 0, Day 3, Day 7|Modified intent-to-treat pediatric population: subgroup of randomized pediatric participants who received any study treatment|||units on a scale||Inter-Quartile Range|Median
2567042|NCT02572817|Secondary|Change From Baseline to Day 3 and Day 7 in National Early Warning (NEW) Score|"The National Early Warning (NEW) score was only measured for the adult participants.~The range of the NEW score is from 0 to 20, with lower values representing a better outcome.~Baseline is defined as the Day 0. Change was defined as the value at Day 3 or Day 7 minus the value at baseline."|Day 0, Day 3, Day 7|Modified intent-to-treat adult population: subgroup of randomized adult participants who received any study treatment|||units on a scale||Inter-Quartile Range|Median
2567043|NCT02572817|Secondary|Composite of Mortality and Hospitalization at Day 7, Day 14, Day 28|"Two categories were considered for the composite of mortality and hospitalization:~Dead or hospitalized Alive and not hospitalized"|Day 7, Day 14, Day 28|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment|||Participants|||Count of Participants
2567044|NCT02572817|Secondary|In-hospital Mortality During Initial Hospitalization|Number of deaths in the hospital during initial hospitalization|From Day 0 to Day 28|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment|||Participants|||Count of Participants
2567045|NCT02572817|Secondary|28-day Mortality|Number of deaths during study follow-up|From Day 0 to Day 28|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment|||Participants|||Count of Participants
2567046|NCT02572817|Secondary|Duration of Initial Hospitalization|Duration (in days) of initial hospitalization, restricted to duration between randomization and last visit|From Day 0 to Day 28|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment|||days||Inter-Quartile Range|Median
2567047|NCT02572817|Secondary|Clinical Status at Day 28|"The clinical status at Day 28 was based on a 6-point ordinal scale:~Death~In ICU~Non-ICU hospitalization, requiring supplemental oxygen (O2)~Non-ICU hospitalization, not requiring supplemental oxygen~Not hospitalized, but unable to resume normal activities~Not hospitalized with full resumption of normal activities A higher score corresponds to a better health outcome"|Day 28|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment|||Participants|||Count of Participants
2567048|NCT02572817|Secondary|Clinical Status at Day 14|"The clinical status at Day 14 was based on a 6-point ordinal scale:~Death~In ICU~Non-ICU hospitalization, requiring supplemental oxygen (O2)~Non-ICU hospitalization, not requiring supplemental oxygen~Not hospitalized, but unable to resume normal activities~Not hospitalized with full resumption of normal activities A higher score corresponds to a better health outcome"|Day 14|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment|||Participants|||Count of Participants
2567192|NCT02570074|Primary|Day 5: Area Under the Concentration Time Curve (AUC Tau-infinity)|To estimate the fosfomycin pharmacokinetic parameter area-under-the-plasma concentration-time curve (AUC 0-tau) at steady-state for orally-dosed fosfomycin tromethamine in healthy adult participants|24 hours||||mg*hours/L||Standard Deviation|Mean
2567049|NCT02572817|Secondary|Clinical Status at Day 3|"The clinical status at Day 3 was based on a 6-point ordinal scale:~Death~In ICU~Non-ICU hospitalization, requiring supplemental oxygen (O2)~Non-ICU hospitalization, not requiring supplemental oxygen~Not hospitalized, but unable to resume normal activities~Not hospitalized with full resumption of normal activities A higher score corresponds to a better health outcome"|Day 3|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment|||Participants|||Count of Participants
2567050|NCT02572817|Secondary|Clinical Status at Day 2|"The clinical status at Day 2 was based on a 6-point ordinal scale:~Death~In ICU~Non-ICU hospitalization, requiring supplemental oxygen (O2)~Non-ICU hospitalization, not requiring supplemental oxygen~Not hospitalized, but unable to resume normal activities~Not hospitalized with full resumption of normal activities A higher score corresponds to a better health outcome"|Day 2|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment|||Participants|||Count of Participants
2567051|NCT02572817|Secondary|Clinical Status at Day 1|"The clinical status at Day 1 was based on a 6-point ordinal scale:~Death~In ICU~Non-ICU hospitalization, requiring supplemental oxygen (O2)~Non-ICU hospitalization, not requiring supplemental oxygen~Not hospitalized, but unable to resume normal activities~Not hospitalized with full resumption of normal activities A higher score corresponds to a better health outcome"|Day 1|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment|||Participants|||Count of Participants
2567052|NCT02572817|Primary|Clinical Status at Day 7|"The clinical status at Day 7 was based on a 6-point ordinal scale:~Death~In ICU~Non-ICU hospitalization, requiring supplemental oxygen (O2)~Non-ICU hospitalization, not requiring supplemental oxygen~Not hospitalized, but unable to resume normal activities~Not hospitalized with full resumption of normal activities A higher score corresponds to a better health outcome"|Day 7|Modified intent-to-treat population: subgroup of randomized participants who received any study treatment (with available data).|||Participants|||Count of Participants
2567053|NCT02572752|Secondary|AUC0-inf|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). The unadjusted geometric mean (gMean) and geometric coefficient variation (gCV) was calculated for Test treatment (T), Reference 1 treatment (R1) and Reference 2 treatment (R2) separately.|-1:00 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 5:30h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2567054|NCT02572752|Primary|Cmax|Maximum measured concentration of the analyte in plasma (Cmax). The unadjusted geometric mean (gMean) and geometric coefficient variation (gCV) was calculated for Test treatment (T), Reference 1 treatment (R1) and Reference 2 treatment (R2) separately.|-1:00 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 5:30h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2567055|NCT02572752|Primary|AUC0-tz|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The unadjusted geometric mean (gMean) and geometric coefficient variation (gCV) was calculated for Test treatment (T), Reference treatment 1 (R1) and Reference treatment 2 (R2) separately.|-1:00 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 5:30h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration.|Pharmacokinetic Set (PKS) : This analysis set included all treated subjects who provided at least 1 observation for at least 1 primary endpoint, and who had no important protocol violations impacting statistical evaluation of PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2567056|NCT02572609|Primary|AUC0-t|Area under the plasma concentration-time curve, calculated by the trapezoidal methods from time 0 to time t, where t is the time for the last concentration experimentally determined above the Limit of Quantification (LOQ).|0:00h (hours), 0:15h, 0:30h, 0:45h, 1:00h, 1:15h, 1:30h, 1:45h, 2:00h, 2:20h, 2:40, 3:00, 3:30h, 4:00h, 5:00h, 6:00h, 8:00h, 12:00h, 16:00h, 24:00h, 36:00h and 48:00h|PK set|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2567057|NCT02572609|Primary|Cmax|Maximum plasma concentration achieved|0:00h (hours), 0:15h, 0:30h, 0:45h, 1:00h, 1:15h, 1:30h, 1:45h, 2:00h, 2:20h, 2:40, 3:00, 3:30h, 4:00h, 5:00h, 6:00h, 8:00h, 12:00h, 16:00h, 24:00h, 36:00h and 48:00h|The pharmacokinetic set (PK Set): 36 subjects provided 1 evaluable value of reference product and 1 evaluable value of test product for the primary PK endpoints (Cmax and AUC0-t) without important protocol violations with respect to the statistical evaluation of PK endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2567058|NCT02572427|Secondary|Knowledge Concerning Intubation of Neonates|Score on cognitive test on intubation of neonates.Scores ranged on scale from 0 to 21 , with higher score indicating greater knowledge (better outcome).|30 minutes||||scores on a scale||Standard Deviation|Mean
2567059|NCT02572427|Primary|Skill in Intubating Neonatal Manikin|Time in seconds needed to intubate neonatal manikin Skill test on neonatal resuscitation in simulation lab|Up to two minutes||||seconds||Standard Deviation|Mean
2567060|NCT02572401|Secondary|Proportion Condom-protected Intercourse|The denominator is the number intercourse acts in the past 90 days and the numerator is the number of condom-protected intercourse acts in the past 90 days. Calculated separately for steady partners and casual partners and analyzed as a repeated outcome.|Baseline, 6 months, 12 months post-intervention|Participants who provided data on the outcome measure at baseline and at least one post-intervention assessment.|||proportion||Standard Deviation|Mean
2567061|NCT02572401|Secondary|Insertive Anal Intercourse|A binary variable indicating whether the participant reported having insertive anal intercourse in the past 90 days. Measured separately for steady partners and casual partners and analyzed as a repeated outcome.|Baseline, 6 months, 12 months post-intervention|Participants who provided data on the outcome measure at baseline and at least one post-intervention assessment.|||Participants|||Count of Participants
2567062|NCT02572401|Secondary|Multiple Partners|Participants whose number of intercourse partners in the past 90 days was 2 or greater are coded as having multiple partners, and those who reported having 0 or 1 intercourse partners in the past 90 days are coded as not having multiple partners.|Baseline, 6 months, 12 months post-intervention|Participants who provide data on the outcome measure at baseline and at least one post-intervention assessment.|||Participants|||Count of Participants
2567063|NCT02572401|Secondary|Unprotected Intercourse|A binary variable indicating whether the participants reported having intercourse in the past 90 days without using a condom. It was constructed by subtracting the sum of the condom-protected intercourse acts from the total number of intercourse acts in the past 90 days. If the difference was one or greater the participant was coded as having unprotected intercourse; if the difference was zero or if the person reported no intercourse in the past 90 days, the person was coded as not having unprotected intercourse. Calculated separately for steady partners and casual partners and analyzed as a repeated outcome.|Baseline, 6 months, 12 months post-intervention|Participants providing the outcome measure at baseline and at least one post-intervention assessment.|||Participants|||Count of Participants
2567064|NCT02572401|Primary|Consistent (100%) Condom Use|A binary variable reflecting whether or not the participant reports using a condom every time he had vaginal or anal intercourse with a woman in the previous 3 months. It will be based on a comparison of the number of protected intercourse acts and the number of intercourse acts. Men who report at least one intercourse act and whose number of reported protected acts equals their number of acts use condoms during 100% of intercourse acts and will be defined as practicing consistent condom use. Men who report at least one intercourse act and whose reported number of protected acts is less than their number of acts will be coded as not practicing consistent condom use. Separate binary variables reflect consistent condom use with steady partners and casual partners analyzed as a repeated outcome.|Baseline, 6 months, 12 months post-intervention|Participants providing primary outcome data at baseline and at least one post-intervention assessment.|||Participants|||Count of Participants
2567065|NCT02572388|Primary|Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Laboratory Adverse Events.|Occurrence of laboratory adverse events defined as clinically significant changes from baseline. Haematology (Full Blood Count) and Biochemistry (Kidney and Liver Function Tests) will be assessed.|At Day 0 (baseline), day 7 and day 28 post vaccination||||participants|||Number
2567066|NCT02572388|Primary|Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Serious Adverse Events.|Occurrence of serious adverse events collected from enrolment until the end of the follow-up period.|6 months|There is no SAEs in groups 2 and 3|||Number of Serious AEs|||Number
2567067|NCT02572388|Primary|Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Unsolicited Adverse Events.|Occurrence of unsolicited local and systemic adverse events.|Unsolicited AEs to be assessed up to 28 days post vaccination.||||participants|||Number
2567068|NCT02572388|Primary|Safety and Tolerability of Administration of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Solicited Local and Systemic Adverse Events.|Occurrence of solicited local and systemic adverse events (i.e: pain, redness, swelling and pruritus at injection site and temperature, feverishness, myalgia, arthralgia, malaise, headache and nausea).|Assessment of solicited AEs in the first 7 days post vaccination.||||Number of Adverse Events per group|||Number
2567069|NCT02572167|Secondary|Progression-free Survival Post-autologous Stem Cell Transplant|PFS is defined as the time from the start of study treatment to the first documentation of disease progression or to death, whichever comes first.|Up to approximately 3 years|||||||
2567070|NCT02572167|Secondary|Duration of Objective Response||Up to approximately 3 years|||||||
2567071|NCT02572167|Secondary|Duration of Complete Response||Up to approximately 3 years|||||||
2567072|NCT02572167|Secondary|Objective Response Rate|Number of patients with complete metabolic response (CMR) or partial metabolic response (PMR)|Up to 3.42 months|The efficacy evaluable analysis set includes all patients who had an adequate baseline disease assessment, received any amount of either drug, and subsequently had an adequate response assessment.|||Participants|||Count of Participants
2567073|NCT02572167|Primary|Complete Remission Rate|Number of patients with complete metabolic response (CMR) at end of treatment|Up to 3.42 months|The Efficacy Evaluable analysis set includes all patients who had an adequate baseline disease assessment, received any amount of either drug, and subsequently had an adequate response assessment.|||Participants|||Count of Participants
2567074|NCT02572167|Primary|Number of Participants With Adverse Events (AEs)|Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. The timeframe includes a 6.01 safety reporting period and additional long-term follow up through 28.9 months.|Up to 28.9 months|The safety analysis set includes all patients who receive any amount of brentuximab vedotin or nivolumab.|||Participants|||Count of Participants
2567075|NCT02572076|Primary|Number of Participants With Boston Bowel Preparation Scale( BBPS) >1 in All Colon Segments After the Use of MCS|"The rating of the cleansing quality was evaluated by using the Boston Bowel Preparation Scale (BBPS), Segment score of 0-3 given to each of the 3 segments of the colon (Left side, Transverse and right side):~Score 0- Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.~Score 1- A portion of the mucosa of the colon segment is seen, but other areas of the colon segment are not seen well due to staining, residual stool, and/or opaque liquid.~Score 2- A minor amount of residual staining, small fragments of stool, and/or opaque liquid are visible, but the mucosa of the colon segment are seen well.~Score 3-The entire mucosa of the colon segment is seen well with no residual staining, small fragments of stool, or opaque liquid.~subject consider as having adequate cleaning if BBPS>1 in all colon segments"|Within 24 hours- During the colonoscopy procedure||||Participants|||Count of Participants
2567076|NCT02571972|Secondary|Maximum Pigment Epithelial Detachment Height|Measurement based on SD-OCT|3 visits (8-12 weeks)|Only 8 of 10 eyes completed study visit 3. The protocol only required follow-up through study visit 2.|||microns|Eyes|Standard Deviation|Mean
2567077|NCT02571972|Secondary|Maximum Subretinal Fluid Height|Measurement based on SD-OCT|3 visits (8-12 weeks)|Only 8 of 10 eyes completed study visit 3. The protocol only required follow-up through study visit 2.|||microns|Eyes|Standard Deviation|Mean
2567078|NCT02571972|Secondary|Visual Acuity|LogMAR Visual acuity on enrollment and final visit|3 visits (8-12 weeks)||||logMAR|Eyes|Standard Deviation|Mean
2567079|NCT02571972|Primary|Mean Central Subfield Thickness (CST)|Mean central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT) on 1 visit prior to enrollment and all visits subsequent to study enrollment|3 visits (8-12 weeks)|Only 8 of 10 eyes completed study visit 3. The protocol only required follow-up through study visit 2.|||microns||Standard Deviation|Mean
2567080|NCT02571634|Secondary|Sedation Level Assessed by POSS Tool|At baseline, 15 minutes post medication receipt, 30 minutes , 45 minutes and at discharge a Pasero-Opioid Sedation Scale Score was obtained. This scale is to measure alertness and amount of sedation. POSS was the abbreviated term used for this scale. The guidelines for that scale include: S= sleeping easily aroused 1= alert and awake; 2= slightly drowsy easily aroused; 3= frequently drowsy, drifts off to sleep during conversation; 4= somnolent, minimal or no response|Baseline, 15 min, 30 min, 45 min, discharge||||POSS sedation scores||Standard Error|Mean
2567081|NCT02571634|Secondary|Adverse Events|Volunteers are monitored closely with vs, and sedation levels and any adverse issues will be recorded.|24 hours|All 23 subjects were monitored with blood pressure, heart rate, oxygen saturation and sedation scores to determine any adverse events.|||number of adverse events|||Number
2567082|NCT02571634|Secondary|Patient Satisfaction Using a Likert Satisfaction Survey|At 24 hour after the procedure a call was made asking the volunteer to provide a number on a scale to describe their satisfaction with their pain control and their overall satisfaction. A 5 point likert scale was used 1 = very satisfied, 2 satisfied, 3 neither satisfied nor dis-satisfied, 4 not satisfied and 5 very unsatisfied.|24 hours|Subjects were asked about pain control satisfaction and overall satisfaction using a 5 point likert scale. 1 = very satisfied, 2= satisfied, 3= neither satisfied nor dis-satisfied, 4= not satisfied and 5 = very unsatisfied|||Units on scale||Standard Deviation|Mean
2567083|NCT02571634|Secondary|Pain Score Differences Using the DVPRS (Defense and Veterans Pain Rating Scale) Tool.|DVPRS pain scores will be recorded baseline and at 15 minutes post dosing, 30 minutes, 45 minutes and discharge. The DVPRS is a pain scale utilizing color coding descriptive terms and faces to describe pain levels from 0 meaning no pain and 10 the most excruciating pain ever.|Baseline, 15 min, 30 min, 45 min, and discharge||||pain score||Standard Error|Mean
2567084|NCT02571634|Primary|Safety and Tolerability as Measured by the Number of Adverse Events|Adverse events will be recorded by a yes or no as to their occurence|24 hours||||adverse events|||Number
2567085|NCT02571452|Secondary|Insomnia Severity (ISI)|Insomnia Severity Index (ISI) is a specific index of perceived insomnia severity. Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on quality of life; and worry about sleep problems. Scores range from 0-28, with higher scores meaning greater impairment. The ISI was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.|Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only|An intent-to-treat analysis was conducted on the 46 participants that completed BBTI treatment. Participants in the PMRT group did not complete the 6-month follow-up assessment and were not included in the analysis.|||score on a scale||Standard Deviation|Mean
2567086|NCT02571452|Secondary|Insomnia Severity (ISI)|The ISI is a specific index of perceived insomnia severity. Areas assessed include problems with sleep onset, sleep maintenance, and early morning awakening; dissatisfaction with sleep; interference with daily functioning; impact on quality of life; and worry about sleep problems. Scores range from 0-28, with higher scores meaning greater impairment. The measure was administered at Baseline (week 0), Mid-treatment (week 3) & Post-treatment (week 5).|Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate|An intent-to-treat analysis was conducted on all participants that started treatment (91), not including the two pilot participants.|||score on a scale||Standard Deviation|Mean
2567087|NCT02571452|Primary|Work and Social Adjustment Scale (WSAS)|The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others. Scores range from 0-40, with higher scores meaning greater impairment. The WSAS was administered at Follow-up (6 months Post-treatment) for participants receiving the experimental treatment only.|Change from Post-treatment to Follow-up (after 6 months)--for treatment arm only|An intent-to-treat analysis was conducted on the 46 participants that completed BBTI treatment. Participants in the PMRT group did not complete the 6-month follow-up assessment and were not included in the analysis.|||score on a scale||Standard Deviation|Mean
2567088|NCT02571452|Primary|Work and Social Adjustment Scale (WSAS)|The WSAS assesses functioning at work, home, management, social leisure activities, private leisure activities, and relationships with others. Scores range from 0-40, with higher scores meaning greater impairment. The measure was administered at Baseline (week 0), Mid-treatment (week 3) & Post-treatment (week 5).|Change from Mid-treatment to Post-treatment (week 3 to week 5), with Baseline as a covariate|An intent-to-treat analysis was conducted on all participants that started treatment (91), not including the two pilot participants.|||score on a scale||Standard Deviation|Mean
2567089|NCT02571439|Other Pre-specified|Itching.|Itching will be assessed postoperatively on a scale of 0 to 10 at 24 hours after surgery. The minimum value was 0 for no itching and maximum value was 10 for severe itching. The responses are whole numbers ranging from 0 to 10 with increasing numbers representing increasing itching.|up to 24 hours after surgery||||scale of 0-10||Inter-Quartile Range|Median
2567090|NCT02571439|Other Pre-specified|Number of Participants With Postoperative Nausea/Vomiting|"outcomes will be assessed postoperatively as number of patients with postoperative nausea/vomiting present or not present at 24 hours after surgery"|up to 24 hours after surgery||||Participants|||Count of Participants
2567091|NCT02571439|Other Pre-specified|Sedation|sedation will be assessed postoperatively on a scale of 0 to 10. The minimum value was 0 for not sedated or awake and maximum value was 10 for extremely sedated. The responses are whole numbers ranging from 0 to 10 with increasing numbers representing increasing sedation.|up to 24 hours after surgery||||scale of 0-10||Inter-Quartile Range|Median
2567092|NCT02571439|Other Pre-specified|Total Narcotic Consumption|Total narcotic consumption, measured in mg of morphine 24 hours after surgery|24 hours after surgery||||mg of morphine||Inter-Quartile Range|Median
2567093|NCT02571439|Secondary|Severity of Postoperative Pain at Rest|postoperative pain will be assessed using the visual analog scale postoperatively at 48 hours after surgery.|48 hours after surgery||||Units on a scale||Inter-Quartile Range|Median
2567094|NCT02571439|Secondary|Severity of Postoperative Pain at Rest|postoperative pain will be assessed using the visual analog scale postoperatively at 24 hours after surgery. v|24 hours after surgery||||Units on a scale||Inter-Quartile Range|Median
2567095|NCT02571439|Secondary|Severity of Postoperative Pain at Rest|postoperative pain will be assessed using the visual analog scale postoperatively at 8 hours after surgery. v|8 hours after surgery||||Units on a scale||Inter-Quartile Range|Median
2567096|NCT02571439|Secondary|Severity of Postoperative Pain at Rest|postoperative pain will be assessed using the visual analog scale postoperatively at 4 hours after surgery. visual analog pain scale is a response scale to measure pain with a score of 0 representing no pain and a score of 10 representing the worst pain imaginable. The minimum value was 0 for no pain and maximum value was 10 for the worst pain imaginable. The responses are whole numbers ranging from 0 to 10 with increasing numbers representing increasing pain.|4 hours after surgery||||Numerical rating scale for pain||Inter-Quartile Range|Median
2567097|NCT02571439|Secondary|Time From Delivery of Neonate to Ready to Exit Operating Room|Two independent observers (who are not the surgeon or anesthesiologist performing the procedures) will collect data on time outcomes to reduce error and the procedure will be filmed on a random sample of 10% of patients to verify the times assigned by the study personnel. Filming will be started after the patient is draped so that the patients face is not in the recording.|Time measures will be recorded in the operating room, upto 6 hours||||minutes||Standard Deviation|Mean
2567098|NCT02571439|Primary|Time Taken to Perform the Block|Two independent observers (who are not the surgeon or anesthesiologist performing the procedures) will collect data on time outcomes to reduce error and the procedure will be filmed on a random sample of 10% of patients to verify the times assigned by the study personnel. Filming will be started after the patient is draped so that the patients face is not in the recording.|The time taken to perform the block in the operating room is measured, upto 60 minutes||||minutes||Standard Deviation|Mean
2567099|NCT02571244|Secondary|Carbon Monoxide Verified Smoking Abstinence|Carbon Monoxide verified Smoking Abstinence at third-month follow up. Abstinence defined as Carbon Monoxide ≤ 6.|At third-month follow up|Intention to Treat Analysis|||Participants|||Count of Participants
2567100|NCT02571244|Secondary|Self Reported Smoking Abstinence|No smoking (even a puff) in the past 7 days at the third month after randomization.|Smoking abstinence at the third month after randomization|The primary analysis was intention-to-treat and involved all patients who were randomly assigned. The 7-day point prevalence abstinence rate, at 3-month assessment, was assessed as a secondary outcome.|||Participants|||Count of Participants
2567101|NCT02571244|Secondary|Self Reported Seek for Specialized Tobacco Treatment|self reported seek for specialized tobacco treatment after hospitalization|at the third month after randomization|It was included only patients that were able to be contacted for follow up (per protocol analysis).|||Participants|||Count of Participants
2567102|NCT02571244|Secondary|Daily Cigarettes Consumption at 3 Months Among Continuing Smokers|The experimental group self reported daily cigarettes consumption at the third month after randomization with be compared to the control group.|At the third month after randomization|It was included only patients that were able to be contacted for follow up (per protocol analysis).|||Number of cigarettes smoked per day||Standard Deviation|Mean
2567103|NCT02571244|Primary|Self Reported Smoking Abstinence|No smoking (even a puff) in the past 7 days at the first month follow up.|Smoking abstinence at the first month after randomization|The primary analysis was intention-to-treat and involved all patients who were randomly assigned. The 7-day point prevalence abstinence rate was assessed as the first outcome (1-month assessment).|||Participants|||Count of Participants
2567104|NCT02571218|Secondary|Acute Ablation Procedure Outcome|Acute AF termination or significant AF cycle length slowing during RF application in ablation procedure|During Ablation|Success rate of radiofrequency catheter ablation to terminate atrial fibrillation during the ablation procedure.|||Participants|||Count of Participants
2567105|NCT02571218|Primary|Long-term Clinical Success Rate|Freedom from symptomatic AF off antiarrhythmic drug therapy assessed from the end of the 3 months blanking period to 12 months following the ablation procedure, documented by implantable loop recorder (ILR) monitoring or trans-telephonic (TT) ECG monitoring.|12 months|Success rate of patient's undergoing radiofrequency catheter ablation during follow up.|||Participants|||Count of Participants
2567106|NCT02571153|Secondary|Percentage of Participants With Tramadol Consumption|Percentage of Participants with Tramadol during the ward stay|24 hours|Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.|||percentage of participants|||Number
2567107|NCT02571153|Secondary|The Severity of Postoperative Pain|"The severity of postoperative pain was rated the higher score of pain (NRS) during the hospital ward stay.~Pain was evaluated using a 0-10 numeric pain rating scale (NRS), where zero meant no pain and 10 the worst imaginable pain."|24 hours|Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.|||units on a scale||80% Confidence Interval|Mean
2567108|NCT02571153|Secondary|Morphine Consumption (mg) at PACU|Morphine consumption (mg) at PACU (about 90 to 120 minutes)|During the stay at postanesthesia recovery room (about 90 to 120 minutes)|Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.|||mg||80% Confidence Interval|Mean
2567109|NCT02571153|Secondary|Occurrence of Pain at PACU Using a 0-10 Numeric Pain Rating Scale|Occurrence of pain at the PACU. Average Pain will be calculated. The pain score will be evaluated using a 0-10 numeric pain rating scale, where zero mean no pain and 10 the worst imaginable pain.|90 minutes postanesthesia at recovery room|Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.|||units on a scale||80% Confidence Interval|Mean
2567110|NCT02571153|Secondary|Occurrence of Postoperative, Nausea and Vomiting|Percentage of participants with postoperative nausea and vomiting at the PACU and during the hospital ward stay|24 hours|Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.|||percentage of participants|||Number
2567111|NCT02571153|Secondary|Length of PACU Stay|Length of stay at postanesthesia recovery room|During the stay at postanesthesia recovery room (about 90 to 120 minutes)|Patients aged 18 to 65 years old, with an ASA physical status I or II, who would be scheduled to undergo laparoscopic cholecystectomy.|||minutes||80% Confidence Interval|Mean
2567193|NCT02570074|Primary|Day 1: Area Under the Concentration Time Curve (AUC 0-infinity)|To estimate the fosfomycin pharmacokinetic parameter area-under-the-plasma concentration-time curve (AUC 0-infinity) at steady-state for orally-dosed fosfomycin tromethamine in healthy adult participants|24 hours||||mg*hour/L||Standard Deviation|Mean
2567112|NCT02571153|Primary|Quality of Postoperative Recovery Assessed by QoR-40 Questionnaire 24 Hours After Surgery|Quality of postoperative functional recovery assessed by the questionnaire QoR40 The quality of postoperative functional recovery was assessed by the QoR-40 questionnaire, which assesses five dimensions of recovery (physical comfort - 12 items; emotional state - 7 items; physical independence - 5 items; physiological support - 7 items; and pain - 7 items). Each item was rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR-40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery). The QoR-40 was administered by a blind investigator 24 hours after surgery.|24 hours|Total of 152 patients were first assessed for eligibility in this study; however, 17 were excluded because they refused participation, or met any of the exclusion criteria. Thus, 135 participants were randomly allocated to the study groups. Later, 6 participants in group S, 8 in group K2, and 2 in group K4 were excluded due to protocol deviations.|||units on a scale||80% Confidence Interval|Mean
2567113|NCT02571075|Secondary|Vomiting Post Operatively|It will be documented yes or no if the participant had any emesis while in recovery prior to discharge home.|1-3 hours post operatively||||Participants|||Count of Participants
2567114|NCT02571075|Secondary|Nausea Post Operatively|It will be documented yes or no if the participant voiced any complaint of nausea while in recovery.|1-3 hours postoperativey||||Participants|||Count of Participants
2567115|NCT02571075|Secondary|Return to Diet|Subjects will record on their diary the date they returned to a regular diet (defined to them what is regular for them)|Within 10 days post operatively||||days||Standard Deviation|Mean
2567116|NCT02571075|Primary|The Morphine Equivalent of Opioid Use|The intraoperative and recovery room morphine equivalents will be calculated and upon diary return what use is recorded by the patient will be done as well. The participant is instructed to write down the type and amount they take throughout that time period.|Intraoperative to 10 days post operative utilizing the Johns Hopkins Opioid conversion system.|Some results based on 10 day diary return but inpatient data available on all subjects|||mg||Standard Deviation|Mean
2567117|NCT02571075|Primary|Pain Scores|Pain scores will be collected daily during the post op period in the recovery room using a numbers scale with faces; specifically the Wong-Baker FACES® Pain Rating Scale where 10 is described as worst possible and 0 is No pain. This was recorded by the participant at home using the same type scale and this was is provided to them. The Hypothesis is that subjects receiving intraoperative auricular acupuncture during a tonsillectomy will have statistically significantly less post-operative pain scores compared to those that do not.|10 days after the procedure.|Only a 50 % diary return completing the full 10 day diary data but had the full inpatient data|||units on a scale||Standard Deviation|Mean
2567118|NCT02571049|Primary|The Percentage of Subjects Reporting Pain Freedom at 60 Minutes Post-treatment||60 minutes post-treatment||||Percentage of responders|||Number
2567119|NCT02570750|Secondary|Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score in Obese Participants|PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). Participants who had bone marrow index >30 kilogram per meter square were said to be obese in this outcome measure.|Baseline, Week 12, 24|"Per protocol set included all treated participants. Here, N (overall number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
2567120|NCT02570750|Secondary|Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12|PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Week 12|Per protocol set included all treated participants.|||units on a scale||Standard Deviation|Mean
2567121|NCT02570750|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 50 (PASI50) Response at Week 12 and 24|PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI50 response was defined as at least a 50% reduction in PASI relative to baseline.|Week 12, 24|Per protocol set included all treated participants.|||percentage of participants|||Number
2567139|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor|Examined for both at the end of level 2 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|8 weeks||||percent of participants|||Number
2567295|NCT02568852|Secondary|Thrombin Time(TT)|measures of the extrinsic and intrinsic pathway of coagulation|Post-operative 1st hour|All patients have gall bladder disease who are between 18-80 years old.|||seconds||Standard Deviation|Mean
2567122|NCT02570750|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24|PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to baseline.|Week 12, 24|Per protocol set included all treated participants.|||percentage of participants|||Number
2567123|NCT02570750|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI)|The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.|Baseline, Week 12, 24|Per protocol set included all treated participants.|||units on a scale||Standard Deviation|Mean
2567124|NCT02570750|Primary|Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24|PASI is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated on a scale of 0 (no involvement) to 6 (90-100 percent involvement), severity was estimated by clinical signs: erythema (E), induration (I), scaling (S) on a 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI = sum of severity parameters for each section*area score*weighing factor (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).|Baseline, Week 24|Per protocol set included all treated participants.|||units on a scale||Standard Deviation|Mean
2567125|NCT02570711|Primary|Overall Response Rate (ORR)|The overall response rate (ORR) of ACP-196 plus nab-paclitaxel/gemcitabine compared with nab-paclitaxel/gemcitabine in patients with previously untreated metastatic pancreatic cancer|At screening, Cycle 3, and Day 1 of every other cycle afterwards (e.g., Cycle 5 Day 1). Every cycle is 28 days.||||Participants|||Count of Participants
2567126|NCT02570425|Secondary|Preference of Device Questionnaire 8 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score|Device preference for either Spiromax or Turbohaler device 8 weeks after baseline visit assessed by PASAPQ Part II Q15 score|8 weeks||||percent of participants|||Number
2567127|NCT02570425|Secondary|Preference of Device Questionnaire 4 Weeks After Baseline Visit Assessed by PASAPQ Part II Q15 Score|Device preference for either Spiromax or Turbohaler device 4 weeks after baseline visit assessed by PASAPQ Part II Q15 score|4 weeks||||percent of participants|||Number
2567128|NCT02570425|Secondary|Preference of Participant Device Questionnaire Assessed by PASAPQ Part II Q15 Score|Device preference for either Spiromax or Turbohaler device at baseline assessed by PASAPQ Part II Q15 score|0 weeks (Visit 1)||||percent of participants|||Number
2567129|NCT02570425|Secondary|Type of Participant Handling Errors Recalled by Expert Assessors 8 Weeks After Baseline Visit by All Participants||8 weeks||||errors|||Number
2567130|NCT02570425|Secondary|Type of Participant Handling Errors by Expert Assessors 4 Weeks After Baseline Visit by All Participants||4 weeks||||errors|||Number
2567131|NCT02570425|Secondary|Type of Participant Handling Errors Recalled by Expert Assessors at Baseline Visit by All Participants||0 weeks (Visit 1)||||errors|||Number
2567132|NCT02570425|Secondary|Number of Assessor-observed Errors Recalled 8 Weeks After Baseline Visit by All Participants|Quantity of errors made at each level recalled by expert assessors at 8 weeks after baseline visit by all participants|8 weeks||||errors|||Number
2567133|NCT02570425|Secondary|Number of Assessor-observed Errors Recalled at 4 Weeks After Baseline Visit by All Participants|Quantity of errors made at each level recalled by expert assessors at 4 weeks after baseline visit by all participants|4 weeks||||errors|||Number
2567134|NCT02570425|Secondary|Number of Assessor-observed Errors Recalled During Baseline Visit by All Participants|Quantity of errors made at each level recalled during baseline visit by all participants using an expert assessor|0 weeks (Visit 1)||||errors|||Number
2567135|NCT02570425|Secondary|The Number of Levels Out of a 6 Level Training Process Required by Each Patient on Achieving Device Mastery as Assessed by Expert Assessor|Number of levels required to achieve device mastery out of a 6 level training processrequired by each patient at each visit as assessed by expert assessor|4 weeks||||levels||Standard Deviation|Mean
2567136|NCT02570425|Secondary|Number of Participants Achieving Device Mastery in Levels 1-6 After 8 Weeks From Baseline Visit as Assessed by Expert Assessor|Number of participants achieving mastery at each level in the 6 level training process after 8 weeks from baseline visit as assessed by expert assessor|8 weeks||||participants|||Number
2567137|NCT02570425|Secondary|Number of Participants Achieving Device Masteryin Levels 1-6 After 4 Weeks From Baseline Visit as Assessed by Expert Assessor|Number of participants achieving mastery at each level in the 6 level training process after 4 weeks from baseline visit as assessed by expert assessor|0 weeks (Visit 1)||||participants|||Number
2567138|NCT02570425|Secondary|Number of Participants Achieving Device Mastery at Levels 1-6 as Assessed by Expert Assessor|Number of participants achieving mastery at each level in the 6 level training process at baseline visit as assessed by expert assessor|0 weeks (Visit 1)||||participants|||Number
2567161|NCT02570126|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination|From Day 0 through the end of study (Day 84)||||Subjects|||Number
2567140|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 8 as Assessed by Expert Assessor|Examined for both at the end of level 1 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|8 weeks||||percent of participants|||Number
2567141|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor|Examined at the end of level 2 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|4 weeks||||percent of participants|||Number
2567142|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process at Week 4 as Assessed by Expert Assessor|Examined at the end of level 1 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|4 weeks||||percent of participants|||Number
2567143|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 2 Out of a 6 Level Training Process as Assessed by Expert Assessor|Examined for both at the end of level 2 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|0 weeks (Visit 1)||||percent of participants|||Number
2567144|NCT02570425|Secondary|Percentage of Participants Achieving Device Mastery at the End of Level 1 Out of a 6 Level Training Process as Assessed by Expert Assessor|Examined for both at the end of level 1 (out of 6 level training process). This will be compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate.|0 weeks (Visit 1)||||percent of participants|||Number
2567145|NCT02570425|Primary|Percentage of Participants Maintaining Correct Inhaler Technique for Spiromax Compared With Turbohaler 4 Weeks After Training as Assessed by Expert Assessor|"Examine if recall of device mastery is superior for the SPIROMAX inhaler as compared to the TURBOHALER after training to device mastery on both devices.~The proportion of subjects achieving mastery of inhaler technique between the two inhaler devices was compared using McNemar's test of equality of paired proportions with a 0.050 two- sided significance level. A Conditional Logistic Regression Model was used to quantify the difference between the two inhalers by calculating the odds ratio for achieving mastery for Spiromax® (with Turbohaler® as the reference device) along with a 95% confidence interval for quantifying the precision of the odds ratio estimate."|4 weeks||||percent of participants|||Number
2567146|NCT02570295|Other Pre-specified|Daily Distance Covered on Foot|Daily distance covered on foot was measured using two accelerometers and one heart rate sensor. Data from weeks 2-9 of the basic military were combined and a single value (mean) was calculated for each group.|Weeks 2 - 9 of the basic military training|The overall number of participants analyzed is smaller than the corresponding number in the participant flow module, because only an exemplary sample of 40 participants per group were chosen to wear the sensors due to financial reasons.|||km per day||Standard Deviation|Mean
2567147|NCT02570295|Other Pre-specified|Daily Energy Expenditure|Daily energy expenditure was measured using two accelerometers and one heart rate sensor. Data from weeks 2-9 of the basic military were combined and a single value (mean) was calculated for each group.|Weeks 2 - 9 of the basic military training|The overall number of participants analyzed is smaller than the corresponding number in the participant flow module, because only an exemplary sample of 40 participants per group were chosen to wear the sensors due to financial reasons.|||Megajoule per day||Standard Deviation|Mean
2567148|NCT02570295|Other Pre-specified|Questionnaire About Sport Lessons|Duration of each sport session was registered in a questionnaire by the military personnel. The minimum would be 0 minutes of sport per week, for the maximum the scale is open-ended. Data of sport lessons during the whole basic military are combined and presented as a mean value for each group.|During the whole basic military training (18 weeks)||||minutes of sport per week||Standard Deviation|Mean
2567149|NCT02570295|Secondary|Attrition Rate|Withdrawals from the military service are reported by the training school's secretariat|During the whole basic military training (18 weeks)||||participants|||Number
2567150|NCT02570295|Secondary|Questionnaire About Health and Physical Activities||Week 1 of the basic military training and 3 months after finishing the basic military training|The overall number of participants analyzed is smaller than the corresponding number in the participant flow module, because only participants who completed the questionnaire at both time points were included in the analysis.|||Minutes of physical activity per week||Standard Deviation|Mean
2567151|NCT02570295|Secondary|Military Performance According to Military Marks|Military marks are given by superior Army personnel. The total score ranges from 1 (insufficient) to 5 (excellent). In total, three marks are given during the whole basic military training (after 7, 11 and 16 weeks). Data from those three time points are combined in a single value (mean).|During the basic military training (18 weeks)|The overall number of participants analyzed is smaller than the corresponding number in the participant flow module, because only participants from whom military marks were available for the whole basic military training were included in the analysis.|||units on a scale 1-5||Standard Deviation|Mean
2567152|NCT02570295|Secondary|Psychological Questionnaires|2 questionaires concerning resilience were used: The Resilience Scale 11 (Schumacher, Leppert, Gunzelmann, Strauss & Brähler, 2005) and the Brief Resilience Scale (Smith, Dalen, Wiggings, Tooley, Christopher & Bernard, 2008). A mean was calculated for each time point. The total score ranges from 1 (worst result) to 7 (best result).|Weeks 2, 10 and 16 of the basic military training|The overall number of participants analyzed is smaller than the corresponding number in the participant flow module, because only participants who the psychological questionnaires at all three time points were included in the analysis.|||units on a scale 1-7||Standard Deviation|Mean
2567153|NCT02570295|Secondary|Physical Fitness Measured With the Swiss Physical Fitness Test Battery (SPFTB)|"Physical Fitness is measured with the Swiss physical fitness test battery (SPFTB).~The SPFTB contains a progressive endurance run, a trunk muscle strength test, a standing long jump, a seated shot put, and a one-leg standing test. From the results of those performance tests (0 to 25 points each), a total fitness score is calculated (sum of all points). The minimum total score (worst result) is 0 points, the maximum total score (best result) is 125 points. A detailed description of the SPFTB can be found in the publication of Wyss, Marti, Rossi, Kohler and Mäder (2007)."|Weeks 2, 10 and 16 of the basic military training|The overall number of participants analyzed is smaller than the corresponding number in the participant flow module, because only participants who completed all three fitness tests were included in the analysis.|||units on a scale from 0 to 125||Standard Deviation|Mean
2567154|NCT02570295|Primary|Number of Participants With Injuries|All injuries which are registered in the patient's medical record are collected and classified. A classification system which takes into account anatomical site, circumstances of the accident, and severity of the injury is used.|During the basic military training (18 weeks)|The overall number of participants analyzed is smaller than the corresponding numbers in the participant flow module, because only participants who finished the whole 18-weeks basic military training were included in the analysis.|||participants with injuries|||Number
2567155|NCT02570165|Secondary|Change From Baseline in Trough FEV1 at Day 42|Trough FEV1 at Day 42 is the mean volume of air that can be forced out in one second after taking a deep breath at the approximately 23 Hrs and 24 Hrs assessments after the last administration of study drug. Batefenterol dose for each individual was compared with placebo or UMEC/VI. Change from Baseline was calculated as trough FEV1 on Day 42 minus baseline, where Baseline is defined as the average of Day1 pre-dose FEV1 measured at -30 minutes and 0 minutes. The Maximum Likelihood Estimation (MLE) method of dose response modeling with Emax modeling without Bayesian priors was used. Participants with FEV1 values available at Baseline and Day 42 after 24 hrs after the last administration of study drug were analyzed.|Baseline and Day 42|ITT Population|||mL||Standard Error|Mean
2567156|NCT02570165|Primary|Change From Baseline in Weighted Mean FEV1 Over 0 to 6 Hours Post-dose at Day 42|FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath. Weighted-mean change from Baseline was the weighted-mean FEV1 on Day 42 minus Baseline where Baseline is defined as the average of Day1 pre-dose FEV1 measured at -30 minutes and 0 minutes. The 0-6 hour (Hr.) serial FEV1 was collected at Day 1 (Visit 2) and Day 42 (Visit 6). The weighted-mean was derived by calculating the area under the curve (AUC) of FEV1 over the 6 hour period, and then dividing it by the 6-hour time interval. Batefenterol dose for each individual was compared with placebo or UMEC/VI. The change from Baseline in FEV1 was statistically analyzed using Bayesian Emax modeling of the dose response curve. Intent-to-Treat (ITT) Population comprised of all participants randomized to treatment and who received at least one dose of study medication. Participants with FEV1 values available at Baseline and Day 42 were analyzed.|Baseline and Day 42|ITT Population.|||Milliliters (mL)||Standard Error|Mean
2567157|NCT02570139|Secondary|Prevention of IAD.|Number of subjects with areas of buttock and thighs that were free of IAD at baseline and remained free of damage with ongoing incontinence through 5 days of treatment.|Measured at study day 5|This is the population who went thru 5 days|||Participants|||Count of Participants
2567158|NCT02570139|Secondary|Pain Scores During Incontinence Management|Pain scores during incontinence management were measured on a 0-10 scale, and analyzed only for subjects from the intent-to-treat dataset who could report pain. Adult pain was measured on 0-10 Wong-Baker FACES® Pain Scale Visual Analog to see if there is pain reduction (0 - no pain; 10 - worst pain). Pain in pediatric patients was measured with the 0-10 FLACC (Face, Legs, Activity, Cry, Consolability Behavioral) Tool. FLACC tool scores pain based on 5 categories, each scored on 0-2 scale and a total score calculated from the sum of the 5 categories for a total possible 0 (no pain) - 10 (worst pain) score. Data from the 2 scales were combined for analysis. Reduction in pain scores collected during product application were reported and least squares means adjusted for baseline pain score as a covariate were calculated. Negative value indicates reduction in pain score; positive value indicates increased pain score.|Up to 21 days depending on length of hospitalization|The patient population analyzed were those who could report pain|||Change in Score on 0-10 Scale||Standard Error|Least Squares Mean
2567159|NCT02570139|Secondary|Re-epithelialization to a Category 1 or Lower|Looking for healing of denuded skin to re-epithelialized skin.|Up to 21 days depending on length of hospitalization|Review and analysis of healing of denuded skin to re-epithelialization.|||Participants|||Count of Participants
2567160|NCT02570139|Primary|Percent Change From Baseline to End of Study in Incontinence Associated Dermatitis (IAD) Scores|Primary endpoint was percent decrease in Incontinence Associated Dermatitis (IAD) score from baseline to end of subject's participation. A negative value indicates increased IAD score; a positive value indicates decreased IAD score. IAD scores were calculated for 6 anatomical zones for color, presence of lesions, and skin loss using 3M's Skin Condition Assessment Tool. Skin condition assessed for 1) epidermal loss depth & area involved; 2) skin color intact skin & % area if not normal color. Intensity scored based on % area involved. Epidermal loss intensity rating scores ranged from 0 (none) - 4 (76-100%) partial (skin open, not weeping) or complete (skin open & weeping). Color of intact skin rating scores ranged from 0 (skin color normal) - 4 (76-100%) skin color pink or red. Scores for each of the 6 body zones were combined to obtain a single IAD score for each subject. IAD scores ranged from 0 (best) - 720 (worst).|up to 21 days depending on length of hospitalization|Analysis was done using the intent-to-treat (ITT) population, using all subjects who had at least one dose of their assigned product.|||percentage change||Standard Error|Mean
2567178|NCT02570074|Secondary|Urinary Bactericidal (UBT) Titers for K. Pneumoniae ATCC 33495|UBT for E.coli K. Pneumoniae ATCC 33495|24 hours on Day 1 and Day 5||||Reciprocal Titers||Inter-Quartile Range|Median
2567162|NCT02570126|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination|43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)|Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with the administered dose 43 days following each vaccination and across doses for each of the 2 groups (VAR_HSA_F Group and VAR Group)|||Subjects|||Number
2567163|NCT02570126|Secondary|Number of Subjects Reporting Febrile Convulsions|Any febrile convulsion = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 febrile convulsion = febrile convulsion which prevented normal, everyday activities. Related febrile convulsion = assessed by the investigator as causally related to study vaccination|43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)|Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with at least one documented dose 43 days following each vaccination and across doses for each of the 2 groups (VAR_HSA_F Group and VAR Group)|||Subjects|||Number
2567164|NCT02570126|Secondary|Number of Subjects Reporting Rash|Any rash = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 rash = rash which prevented normal, everyday activities. Related rash = assessed by the investigator as causally related to study vaccination|43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)|Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with at least one documented dose 43 days following each vaccination and across doses for each of the 2 groups (VAR_HSA_F Group and VAR Group)|||Subjects|||Number
2567165|NCT02570126|Secondary|Number of Subjects Reporting Fever|Any fever (≥ 38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination. Grade 3 fever = temperature > 39.5°C. Related fever = assessed by the investigator as causally related to study vaccination|43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)|Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with the documented dose 43 days following each vaccination and across doses for each of the 2 groups (VAR_HSA_F Group and VAR Group)|||Subjects|||Number
2567166|NCT02570126|Secondary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed were pain, injection site redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = subject crying when limb was moved or as spontaneously painful. Grade 3 redness and swelling = above (>) 20 mm|4-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)|Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with at least one documented dose 4 days following each vaccination and across doses for each of the 2 groups (VAR_HSA_F Group and VAR Group)|||Subjects|||Number
2567167|NCT02570126|Secondary|Number of Subjects With a Seroresponse to VZV (Immuno Sub Cohort)|For VZV, seroresponse was defined as, post-vaccination anti-VZV antibody concentration ≥ 50 mIU/mL among subjects who were seronegative (antibody concentration below (< ) 25 mIU/mL) before vaccination|At Day 42 and Day 84 post vaccination|Immunogenicity analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity. Seropositivity was assessed in sub cohort of the ATP cohort for immunogenicity for each group (immuno sub cohort) who had blood taken and tested for anti-varicella antibodies at Day 0, Day 42, and Day 84|||Subjects|||Number
2567168|NCT02570126|Secondary|Evaluation of Immune Response to Varicella Vaccine With Respect to Anti Varicella Zoster Virus (Anti-VZV) Antibody Concentrations (Immuno-sub Cohort)|Anti-VZY antibody concentrations were expressed in terms of Geometric Mean Concentrations (GMCs)|At Day 42 and Day 84 post vaccination|Immunogenicity analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity. Immune response (in terms of GMC) was assessed in sub cohort of the ATP cohort for immunogenicity for each group (immuno sub cohort) who had blood taken and tested for anti-varicella antibodies at Day 0, Day 42, and Day 84|||mIU/mL||95% Confidence Interval|Geometric Mean
2567169|NCT02570126|Secondary|Number of Subjects Reporting Fever|Fever was defined as axillary temperature greater than or equal to (≥) 38.0°C (≥ 100.4°F)|15 days post each dose of varicella vaccination|Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with documented dose 15-days post each dose of varicella vaccination for each of the 2 groups (VAR_HSA_F Group and VAR Group)|||Subjects|||Number
2567170|NCT02570126|Primary|Number of Subjects Reporting Fever|Fever was defined as axillary temperature above (>) 39.0 °C (> 102.2°F)|15-days (Days 0-14) post Dose 1 of varicella vaccination|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with administration of either Varilrix HSA-free or Varilrix™vaccine documented. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with documented dose 15-days (Days 0-14) post Dose 1 of varicella vaccination|||Subjects|||Number
2567171|NCT02570074|Secondary|Urinary Inhibitory (UIT) Titers for P. Mirabilis ATCC 35659|UIT for P. Mirabilis ATCC 35659|24 hours on Day 1 and Day 5||||Reciprocal Titers||Inter-Quartile Range|Median
2567172|NCT02570074|Secondary|Urinary Inhibitory (UIT) Titers for K. Pneumoniae ATCC 700603|UIT for K. Pneumoniae ATCC 700603|24 hours on Day 1 and Day 5||||Reciprocal Titers||Inter-Quartile Range|Median
2567173|NCT02570074|Secondary|Urinary Inhibitory (UIT) Titers for K. Pneumoniae ATCC 33495|UIT for E.coli K. Pneumoniae ATCC 33495|24 hours on Day 1 and Day 5||||Reciprocal Titers||Inter-Quartile Range|Median
2567174|NCT02570074|Secondary|Urinary Inhibitory (UIT) Titers for E. Coli ATCC BAA-2323|UIT for E. Coli ATCC BAA-2323|24 hours on Day 1 and Day 5||||Reciprocal Titers||Inter-Quartile Range|Median
2567175|NCT02570074|Secondary|Urinary Inhibitory (UIT) Titers for E. Coli ATCC 25922|UIT for E.coli ATCC 25922|24 hours on Day 1 and Day 5||||Reciprocal Titers||Inter-Quartile Range|Median
2567176|NCT02570074|Secondary|Urinary Bactericidal (UBT) Titers for P. Mirabilis ATCC 35659|UBT for P. Mirabilis ATCC 35659|24 hours on Day 1 and Day 5||||Reciprocal Titers||Inter-Quartile Range|Median
2567177|NCT02570074|Secondary|Urinary Bactericidal (UBT) Titers for K. Pneumoniae ATCC 700603|UBT for K. Pneumoniae ATCC 700603|24 hours on Day 1 and Day 5||||Reciprocal Titers||Inter-Quartile Range|Median
2567194|NCT02570074|Primary|Maximum Plasma Concentration (Cmax)|To estimate the fosfomycin pharmacokinetic parameter maximum plasma concentration (Cmax) at steady-state for orally-dosed fosfomycin tromethamine in healthy adult participants|24 hours|Please note that one person did not complete the Fosfomycin 3 doses QoD regimen.|||mg/L||Standard Deviation|Mean
2567195|NCT02570074|Primary|Day 5: Plasma PK Concentrations [mg/L]|Day 5 mean and standard deviation plasma concentrations [mg/L] at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours from dose|Day 5: 0, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours from dose|Please note that one person did not complete the Fosfomycin 3 doses QoD regimen.|||mg/L||Standard Deviation|Mean
2567196|NCT02570074|Primary|Day 1: Plasma PK Concentrations [mg/L]|Day 1 mean and standard deviation plasma concentrations [mg/L] at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours from dose|Day 1: 0, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours from dose|Please note that one person did not complete the Fosfomycin 3 doses QoD regimen.|||mg/L||Standard Deviation|Mean
2567197|NCT02570074|Primary|Number (%) of Grade 2 or Higher AEs Regardless of Relationship to Study Drug||3 months||||Participants|||Count of Participants
2567198|NCT02570022|Secondary|Morphine Equivalents|Patients recorded opioid intake for four days postoperatively. Patients average daily morphine consumption was determined by averaging total patients daily morphine consumption by the number of patients.|four days postoperatively||||mg of morphine equivalent||Standard Deviation|Mean
2567199|NCT02570022|Primary|Pain Levels|Patients recorded pain levels every four hours using Visual analog scales for four days post operatively. Average daily pain was calculated for each patient. Range of the visual analog scale was 0-10, where 0 indicated a lower amount of pain and 10 indicated higher amount of pain.|four days postoperatively||||units on a scale||Standard Deviation|Mean
2567200|NCT02569996|Secondary|Disease-free Survival (DFS)|Disease free survival (DFS) being defined as time from first documented complete response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.|From first documented complete response to induction treatment to relapse or progression or death, whichever occurs first, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis. Subset of the ITT population was used since not the entire ITT population provided appropriate data for analysis.|||months||95% Confidence Interval|Mean
2567201|NCT02569996|Secondary|Duration of Response (DR)|Duration of Response (DR) defined as time from first documented response to induction treatment to relapse or progression or death from the follicular lymphoma. Mean DR was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.|From first documented response to induction treatment to relapse or progression or death, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis. Subset of the ITT population was used since not the entire ITT population provided appropriate data for analysis|||months||95% Confidence Interval|Mean
2567202|NCT02569996|Secondary|Time to Next Anti-lymphoma Treatment (TTNLT)|Time to next anti-lymphoma treatment (TTNLT) defined as time from baseline to institution of a new antilymphoma regimen (including chemo-, radio- or immunotherapies). Mean TTNLT was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval.|From baseline (Week 0) to institution of a new antilymphoma regimen, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.|||months||95% Confidence Interval|Mean
2567203|NCT02569996|Secondary|Time to Progression (TTP)|Time to progression (TTP) defined as time from baseline to disease progression or relapse, death from the follicular lymphoma or institution of a new regimen because of the follicular lymphoma. Mean TTP was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis.|From baseline (Week 0) to disease progression, relapse, death from the follicular lymphoma or institution of a new regimen, whichever occurs first, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.|||months||95% Confidence Interval|Mean
2567204|NCT02569996|Secondary|Overall Survival (OS)|Overall survival, defined as the time between baseline (Week 0) and the date of death irrespective of the cause of death. Mean OS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population was used for this analysis.|From randomization until death, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.|||months||95% Confidence Interval|Mean
2567205|NCT02569996|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect, requires intervention to prevent permanent impairment or damage, or results in death|Up to 27 months|Safety population: All participants who received at least one dose of study medication and had safety data after the first dose of study drug.|||participants|||Number
2567206|NCT02569996|Primary|Event-free Survival|Event-free survival (EFS) was defined as the time from baseline (Week 0) to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first. Mean EFS was estimated by the Kaplan-Meier estimation and provided with their 95% confidence interval. ITT population (patients who received at least one maintenance MabThera infusion) was used for this analysis.|From randomization to the time to progression, relapse, death from any cause, or institution of a new treatment, whichever occurs first, assessed up to 5 years|ITT population: All participants who received at least one maintenance rituximab infusion were included in the analysis.|||months||95% Confidence Interval|Mean
2567207|NCT02569957|Secondary|Proportion of Patients Experiencing Adverse Events, Evaluated Using the National Cancer Institute CTCAE Version 4.0|Tabulated and reported with the corresponding exact binomial confidence intervals.|Up to 24 months|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
2567208|NCT02569957|Secondary|Duration of Response|Compared between the two arms using the two-sample Wilcoxon test.|Up to 24 months|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
2567209|NCT02569957|Secondary|Objective Tumor Response Rates|Evaluated using the exact binomial confidence intervals and compared between the two arms using the Fisher's exact test.|Up to 24 months|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
2567210|NCT02569957|Secondary|Overall Survival|Compared between the two arms using the log-rank test.|Up to 24 months|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
2567211|NCT02569957|Secondary|Progression-free Survival|Compared between the two arms using the log-rank test.|Up to 24 months|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
2567212|NCT02569957|Secondary|Change in Number of Circulating Tumor Cells|Compared pre-therapy and post- 1 cycle of therapy with a Fisher's exact test.|Baseline to day 29|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
2567213|NCT02569957|Secondary|Change in Expression Levels of NFκB in Tissue Samples|Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels.|Baseline to up to day 20 after first course of topotecan hydrochloride|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
2567214|NCT02569957|Secondary|Change in Expression Levels of HIF-1 Alpha in Tissue Samples|Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels.|Baseline to up to day 20 after first course of topotecan hydrochloride|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
2567215|NCT02569957|Secondary|Change in Expression Levels of FABP4 in Tissue Samples|Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels.|Baseline to up to day 20 after first course of topotecan hydrochloride|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
2567216|NCT02569957|Secondary|Change in Expression Levels of TOMM20 in Tissue Samples|Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels.|Baseline to up to day 20 after first course of topotecan hydrochloride|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
2567217|NCT02569957|Secondary|Change in Expression Levels of MCT1 in Tissue Samples|Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels.|Baseline to up to day 20 after first course of topotecan hydrochloride|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
2567218|NCT02569957|Secondary|Change in Expression Levels of Cav-1 in Tissue Samples|Evaluated in a generalized linear mixed effects model adjusting for the random subject effects. The expression levels will be log or otherwise transformed, if necessary, to satisfy the normal distribution assumption of the model. The fitted model will be used to evaluate the post-treatment change in the expression levels.|Baseline to up to day 20 after first course of topotecan hydrochloride|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
2567219|NCT02569957|Primary|Proportion of Patients Who Demonstrate a Downregulation of MCT4|The two-sided Fisher's exact test with alpha 0.05 will be used to compare the proportions of subjects who demonstrate a downregulation of MCT4 between subjects treated with topotecan hydrochloride and NAC and topotecan hydrochloride alone.|Baseline to up to day 20 after first course of topotecan hydrochloride|The trial was halted prematurely due to slow accrual. Data were not collected and the Outcome will never be analyzed.||||||
2567220|NCT02569853|Secondary|The Percentage of Subjects in the Double-blind Period Who Are Pain Free at 1 Hour After Dosing as Reported by the Subject in the eDiary||1 hour|Subjects analyzed had efficacy data at the time of specified assessment|||Percentage of responders|||Number
2567221|NCT02569853|Primary|The Percentage of Subjects in the Double-blind Period Who Are Pain Free at 2 Hours After Dosing as Reported by the Subject in the eDiary||2 hours|Subjects analyzed had efficacy data at the time of specified assessment|||Percentage of responders|||Number
2567222|NCT02569710|Secondary|Number of Participants With HCV Nonstructural Protein NS5A, NS5B, and NS3/4A Sequence in Participants With Virologic Failure|Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants with virologic failure.|Up to Week 24 (Follow up visit)|Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Participants who had virologic failure were included in this outcome measure.|||Participants|||Count of Participants
2567223|NCT02569710|Secondary|Time to Achieve Undetectable HCV RNA or < LLOQ HCV RNA|Time to achieve undetectable HCV RNA or < LLOQ HCV RNA was reported.|Up to Week 24 (follow up visit)|Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Data was not collected and analyzed for this outcome measure as per the change in planned analysis.||||||
2567296|NCT02568852|Secondary|Thrombin Time(TT)|measures of the extrinsic and intrinsic pathway of coagulation|pre-operative|All patients have gall bladder disease who are between 18-80 years old.|||seconds||Standard Deviation|Mean
2567224|NCT02569710|Secondary|Percentage of Participants Who Achieved HCV RNA <LLOQ|Percentage of participants who achieved HCV RNA <LLOQ was reported.|Day 2, 3, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)|Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.|||Percentage of participants|||Number
2567225|NCT02569710|Secondary|Percentage of Participants Who Achieved HCV RNA Less Then (<) LLOQ Undetectable|Percentage of participants who achieved HCV RNA less then (<) LLOQ undetectable was reported.|Day 2, 3, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)|Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.|||Percentage of participants|||Number
2567226|NCT02569710|Secondary|Percentage of Participants With On-treatment Failure|On-treatment failure was defined by participants who did not achieve SVR12 and with confirmed HCV RNA >= LLOQ at the actual end of study drug treatment.|Up to 12 weeks|Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.|||Percentage of participants|||Number
2567227|NCT02569710|Secondary|Percentage of Participants With Virologic Relapse During the Follow-up Period|Viral relapse is defined as participants SVR12, with HCV RNA <LLOQ at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow up.|Follow up period (Up to Week 12 after end of treatment)|Safety set included all participants enrolled into study who had received at least 1 dose of any study drug, whether prematurely withdrawn from study or not.|||Percentage of participants|||Number
2567228|NCT02569710|Secondary|Average Plasma Concentration at Steady State (Css,Avg) of Odalasvir|Css,avg is the average plasma concentration at steady state of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||ng/ml||Standard Deviation|Mean
2567229|NCT02569710|Secondary|Tlast of Odalasvir|Tlast is the time corresponding to last measurable plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||Hours||Full Range|Median
2567230|NCT02569710|Secondary|Clast of Odalasvir|Clast is the last measurable plasma concentration (Clast) of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||ng/ml||Standard Deviation|Mean
2567231|NCT02569710|Secondary|AUC (0-24) for Odalasvir|AUC(0-24) is the area under the plasma concentration-time curve from time zero to time 24 hours for odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||ng*h/mL||Standard Deviation|Mean
2567232|NCT02569710|Secondary|AUC (0-last) of Odalasvir|AUC(0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||ng*h/ml||Standard Deviation|Mean
2567233|NCT02569710|Secondary|Tmax of Odalasvir|Tmax is the time to reach the maximum plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||Hours||Full Range|Median
2567234|NCT02569710|Secondary|Ctrough of Odalasvir|Ctrough is the trough plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||ng/ml||Standard Deviation|Mean
2567297|NCT02568852|Secondary|aPTT(Activated Partial Thromboplastin Time)|measures of the intrinsic pathway of coagulation|Post-operative 24th hours|All patients have gall bladder disease who are between 18-80 years old.|||seconds||Standard Deviation|Mean
2567235|NCT02569710|Secondary|Cmax of Odalasvir|Cmax is the maximum observed plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||ng/ml||Standard Deviation|Mean
2567236|NCT02569710|Secondary|Cmin of Odalasvir|Cmin is the minimum observed plasma concentration of odalasvir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||ng/ml||Standard Deviation|Mean
2567237|NCT02569710|Secondary|Average Plasma Concentration at Steady State (Css,Avg) of Simeprevir|Css,avg is the average plasma concentration at steady state of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||ng/ml||Standard Deviation|Mean
2567238|NCT02569710|Secondary|Tlast of Simeprevir|Tlast is the time corresponding to last measurable plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||Hours||Full Range|Median
2567239|NCT02569710|Secondary|Clast of Simeprevir|Clast is the maximum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||ng/ml||Standard Deviation|Mean
2567240|NCT02569710|Secondary|AUC (0-24) of Simeprevir|AUC (0-24) is the area under the plasma concentration-time curve from time 0 to 24 hours of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||ng*h/ml||Standard Deviation|Mean
2567241|NCT02569710|Secondary|AUC (0-last) of Simeprevir|AUC (0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||ng*h/ml||Standard Deviation|Mean
2567242|NCT02569710|Secondary|Tmax of Simeprevir|Tmax is the Time to reach the maximum plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||Hours||Full Range|Median
2567243|NCT02569710|Secondary|Ctrough of Simeprevir|Ctrough is the trough plasma concentration of Simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||ng/ml||Standard Deviation|Mean
2567244|NCT02569710|Secondary|Cmax of Simeprevir|Cmax is the maximum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||ng/ml||Standard Deviation|Mean
2567298|NCT02568852|Secondary|aPTT(Activated Partial Thromboplastin Time)|measures of the intrinsic pathway of coagulation|Post-operative 1st hour|All patients have gall bladder disease who are between 18-80 years old.|||seconds||Standard Deviation|Mean
2567299|NCT02568852|Secondary|aPTT(Activated Partial Thromboplastin Time)|measures of the intrinsic pathway of coagulation|pre-operative|All patients have gall bladder disease who are between 18-80 years old.|||seconds||Standard Deviation|Mean
2567245|NCT02569710|Secondary|Cmin of Simeprevir|Cmin is the minimum measured plasma concentration of simeprevir. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||ng/ml||Standard Deviation|Mean
2567246|NCT02569710|Secondary|Average Plasma Concentration at Steady State (Css,Avg) of ALS-022227|Css,avg is the average plasma concentration at steady state of ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||ng/ml||Standard Deviation|Mean
2567247|NCT02569710|Secondary|Time Corresponding to Last Measurable Plasma Concentration (Tlast) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)|Tlast is the time corresponding to last measurable plasma concentration for AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||Hours||Full Range|Median
2567248|NCT02569710|Secondary|Last Measurable Plasma Concentration (Clast) of AL-335 and Its Metabolite (ALS-022399 and ALS-022227)|Clast is the last measurable plasma concentration (Clast) of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||ng/ml||Standard Deviation|Mean
2567249|NCT02569710|Secondary|Area Under the Plasma Concentration Time-Curve at 24 Hours (AUC0-24) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)|AUC(0-24) is the area under the plasma concentration-time curve from time zero to time 24 hours for AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||ng*h/mL||Standard Deviation|Mean
2567250|NCT02569710|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Plasma Concentration (AUC [0-last]) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)|AUC(0-last) is the area under the plasma concentration-time curve from time 0 to last measurable plasma concentration of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||nanogram*hours per milliliters (ng*h/mL)||Standard Deviation|Mean
2567251|NCT02569710|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)|Tmax is the time to reach the maximum plasma concentration of AL-335, ALS-022399 and ALS-022227. For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||Hours||Full Range|Median
2567252|NCT02569710|Secondary|Trough Plasma Concentration (Ctrough) for AL-335 and Its Metabolites (ALS-022399 and ALS-022227)|Ctrough is the trough plasma concentration for AL-335 and its metabolites (ALS-022399 and ALS-022227). For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis. Here, 'n' signifies the number of participants analyzed for specified analyte.|||ng/ml||Standard Deviation|Mean
2567253|NCT02569710|Secondary|Maximum Observed Plasma Concentration (Cmax) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)|Cmax is the maximum observed plasma concentration of AL-335 and its metabolites (ALS-022227). For PK analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||ng/mL||Standard Deviation|Mean
2567300|NCT02568852|Secondary|D-Dimer|A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis|Post-operative 24th hours|All patients have gall bladder disease who are between 18-80 years old.|||mg/L||Standard Deviation|Mean
2567254|NCT02569710|Secondary|Minimum Observed Plasma Concentration (Cmin) of AL-335 and Its Metabolites (ALS-022399 and ALS-022227)|Cmin is the minimum observed plasma concentration of AL-335 and its metabolites (ALS-022399 and ALS-022227). For Pharmacokinetic (PK) analyses, cohorts were grouped by treatment dosage (not duration of treatment) for participants without cirrhosis (Cohort 1; Cohort 1b+4; Cohort 2+3+5) and for participants with cirrhosis (Cohort 6; Cohort 7+8+9+11).|Predose, 0.5, 1, 2, 3, 4, 6, 9, and 24 hours postdose (Week 2), 2-4 hours postdose (Weeks 3 and 6), 6-8 hours postdose (Weeks 4 and 8)|PK set: all safety set participants except those who violated inclusion/exclusion criteria, deviated from protocol, or if data were unavailable/incomplete which influenced PK analysis.|||nanogram per milliliter (ng/ml)||Standard Deviation|Mean
2567255|NCT02569710|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at Week 4, 12 and 24 After End of Treatment|Participants were considered to have achieved SVR if the Hepatitis C virus (HCV) Ribonucleic acid (RNA) less than (<) Lower limit of quantification (LLOQ) (<15 international unit per milliliter [IU/mL]) detectable or undetectable at Week 4, 12 and 24 after the actual end of study drug treatment.|At Week 4, 12 and Week 24 after end of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)|Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.|||Percentage of participants||95% Confidence Interval|Number
2567256|NCT02569710|Primary|Percentage of Participants With Worst Treatment Emergent Abnormalities of Electrocardiogram (ECG) Parameters|Percentage of participants with worst treatment emergent abnormalities of ECG parameters (Fridericia Corrected QT interval [QTcF], Bazett Corrected QT interval [QTcB], Heart rate, QRS and PR, was reported. For QTcF abnormality was defined as 30 milliseconds (ms) less than or equal to (<=) QTcF increase from baseline <= 60 ms; for QTcB abnormality was defined as 30 ms <= QTcB increase from baseline <= 60 ms; for heart rate - abnormal low: <= 50 beats per minute (bpm) and abnormal high: >= 120 bpm; for QRS - abnormal high: >120 ms; for PR - abnormally low: PR < 120 ms; abnormally high - 200 ms < PR <= 240 ms and 240 ms < PR <= 300 ms.|Up to 43 weeks|Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.|||Percentage of participants|||Number
2567257|NCT02569710|Primary|Percentage of Participants by Treatment Emergent Toxicity Grade - Urinalysis Parameter (Protein)|Percentage of participants by treatment emergent toxicity grade (Grade 1, 2, 3, 4, 3+4) for urinalysis parameter (protein) was reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.|Up to 43 weeks|Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.|||Percentage of participants|||Number
2567258|NCT02569710|Primary|Percentage of Participants by Treatment Emergent Toxicity Grade - Prothrombin International Normalized Ratio (INR)|Percentage of participants by treatment emergent toxicity grade for coagulation parameter (Prothrombin International Normalized Ratio) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.|Up to 43 weeks|Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.|||Percentage of participants|||Number
2567259|NCT02569710|Primary|Percentage of Participants by Treatment Emergent Toxicity Grade - Blood Chemistry Parameters|Percentage of participants by treatment emergent toxicity grade (Grade 1,2,3,4,3+4) for Blood Chemistry (Calcium, Phosphate, Potassium, Sodium, Bicarbonate, Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase, Bilirubin, Direct bilirubin, Glucose, Cholesterol, Triglycerides, Urate, Triacylglycerol lipase, Creatinine, Creatinine clearance, Albumin and Creatine kinase) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.|Up to 43 weeks|Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.|||Percentage of participants|||Number
2567260|NCT02569710|Primary|Percentage of Participants by Treatment Emergent Toxicity Grade - Hematology Parameters|Percentage of participants by treatment emergent toxicity grade (1, 2, 3, 4 and 3+4) for Hematology parameters (hemoglobin, lymphocytes, neutrophils, leukocytes, platelets) were reported. Toxicity grades were defined as Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe and Grade 4: potentially life-threatening. A toxicity is treatment-emergent if it is worse than the baseline or if baseline is missing.|Up to 43 weeks|Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.|||Percentage of participants|||Number
2567261|NCT02569710|Primary|Percentage of Participants With Maximum Decrease From Baseline in Mean Ejection Fraction|Percentage of participants with maximum decrease from baseline in mean ejection fraction was reported. Percentages are based on the number of participants with available data.|Baseline up to End of treatment (up to 43 weeks)|Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.|||Percentage of participants|||Number
2567262|NCT02569710|Primary|Percentage of Participants With Worst Post-Baseline Values of Vital Signs|Percentage of participants with worst post-baseline values of vital signs (Systolic blood pressure [sBP], Diastolic blood pressure [dBP], and Heart rate) were reported. For sBP, abnormally low: less than or equal to [<=] 90 millimeters mercury [mmHg]; Grade 1 or mild: greater than [>] 140 to less than [<] 160 mmHg; Grade 2 or moderate: >=160 to <180 and Grade 3 or severe: >=180 mmHg. For dBP, abnormally low: <=50 mmHg; Grade 1 or mild: >90 to <100 mmHg; Grade 2 or moderate: >=100 to <110 mmHg and Grade 3 or severe: >=110 mmHg. For Heart Rate, abnormally low: <=50 beats per minute [bpm] and abnormally high: >=120 bpm.|Up to 43 weeks|Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.|||Percentage of participants|||Number
2567301|NCT02568852|Secondary|D-Dimer|A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis|Post-operative 1st hour|All patients have gall bladder disease who are between 18-80 years old.|||mg/L||Standard Deviation|Mean
2567263|NCT02569710|Primary|Body Mass Index (BMI) at End of Treatment|BMI was calculated by dividing the body weight (in kilogram) by the square of height (in meters). BMI at end of treatment was reported.|End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)|Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Here, N (number of participants analyzed) signifies number of participants evaluable for this endpoint.|||Kilograms per square meter (Kg/m^2)||Standard Deviation|Mean
2567264|NCT02569710|Primary|Body Weight at End of Treatment|Body weight (measured using a calibrated scale) at end of treatment was reported.|End of treatment (Cohort 3: 6 weeks; Cohort 1, Cohort 1b+ Cohort 4, Cohort 2, Cohort 5a, and Cohort 6, 7, 8: 8 weeks; Cohort 4, Cohort 5b, Cohort 9 and Cohort 11: 12 weeks)|Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not. Here, N (number of participants analyzed) signifies number of participants evaluable for this endpoint.|||Kilograms (kg)||Standard Deviation|Mean
2567265|NCT02569710|Primary|Number of Participants With Treatment Emergent Adverse Event (TEAE)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between administration of study drug and up to 43 weeks that were absent before treatment or that worsened relative to pre-treatment state.|Up to 43 weeks|Safety set included all participants enrolled into the study who had received at least 1 dose of any study drug, whether prematurely withdrawn from the study or not.|||Participants|||Count of Participants
2567266|NCT02569658|Secondary|Number of Participants With Stroke|Must be diagnosed via CT scan or MRI|30 days post-operative||||Participants|||Count of Participants
2567267|NCT02569658|Secondary|Number of Participants With Pulmonary Embolism|Must be diagnosed via CT chest or V/Q lung scan|30 days post-operative||||Participants|||Count of Participants
2567268|NCT02569658|Secondary|Number of Participants With Deep Vein Thrombosis|Must be diagnosed via ultrasound duplex|30 days post-operative||||Participants|||Count of Participants
2567269|NCT02569658|Secondary|Number of Patients Transfused|Patients who received a post-op transfusion of pack red blood cells|Average of 3 days post-operatively||||Participants|||Count of Participants
2567270|NCT02569658|Secondary|Number of Units Transfused|Units of pack red blood cells that the patients recieved|Average of 3 days post-operatively||||Units of PRBCs|||Number
2567271|NCT02569658|Primary|Post-operative Blood Loss|Equated based on the patient's predicted blood volume and change in hemoglobin from the pre-operative level to the lowest post-operative level.|Average of 3 days post-operatively||||mL||Standard Deviation|Mean
2567272|NCT02569541|Secondary|Clinical Success at 24 Months|"Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 24-Month Visit.~Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia"|24 months after start of treatment|ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study.|||Participants|||Count of Participants
2567273|NCT02569541|Secondary|Clinical Success at 21 Months|"Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 21-Month Visit.~Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia"|21 months after start of treatment|ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study.|||Participants|||Count of Participants
2567274|NCT02569541|Secondary|Clinical Success at 18 Months|"Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 18-Month Visit.~Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia"|18 months after start of treatment|ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study.|||Participants|||Count of Participants
2567285|NCT02569398|Secondary|Change From Baseline in Neuropsychological Assessment Battery Daily Living Tests (NABDLTs) Score at Endpoint (Month 24)|The Neuropsychological Assessment Battery Daily Living Tests (NABDLTs) Score represent a series of performance based measures covering 5 domains (Attention, Memory, Language, Spatial, and Executive function). These are valid, clinically meaningful measures that objectively assess functional deficits. Participant performance scores on NAB subtests are summed, and then normalized to yield an index score. Index scores can range from less than or equal to (< =) 55 to greater than or equal to (> =) 145, and are normalized to a mean of 100 and standard deviation of 15. Higher scores indicate less impairment.|Baseline and Endpoint (Month 24)|As the study was terminated early with lesser participants and lesser sample size, data for this endpoint was not collected and analyzed per change in planned analysis.||||||
2567275|NCT02569541|Secondary|Clinical Success at 15 Months|"Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 15-Month Visit.~Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia"|15 months after start of treatment|ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study.|||Participants|||Count of Participants
2567276|NCT02569541|Secondary|Clinical Success at 12 Months|"Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 12-Month Visit.~Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia"|12 months after start of treatment|ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study.|||Participants|||Count of Participants
2567277|NCT02569541|Secondary|Clinical Success at 9 Months|"Number of participants in the ITT analysis set who meet all the criteria for clinical success at the 9-Month Visit.~Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia"|9 months after start of treatment|ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study.|||Participants|||Count of Participants
2567278|NCT02569541|Secondary|Safety and Tolerability|"Number of participants with TEAEs, SAEs, deaths, and discontinuations due to AEs.~Treatment-emergent adverse events, defined as events with a start date on or after the initiation of study drug through 28 days after the last dose of study drug, are reported."|Entire study period - up to 24 months|Safety population - all enrolled subjects who received at least 1 dose of study drug.|||Participants|||Count of Participants
2567279|NCT02569541|Primary|Clinical Success at 6 Months|"Number of participants in the intent to treat (ITT) analysis set who meet all the criteria for clinical success at the 6-Month Visit.~Clinical success was defined to occur when subjects met all of the following criteria: 1) Subject was not hospitalized due to worsening of the study-qualifying orthopedic infection. 2) Subject did not undergo a definitive surgical procedure (such as amputation). 2) No additional antibiotics (after completion of companion antibiotics) are required for treatment of the orthopedic infection due to the inclusionary pathogen. 3) Wound is closed, or the open area decreased in size (L x W) and, if a skin graft was done, the graft remains viable without evidence of infection. 4) No purulent discharge from the surgical wound, or new or recurring sinus tract. 5) No worsening of redness, tenderness, or swelling at the primary infection site. 5) No bacteremia"|6 months after start of treatment|ITT Population - all subjects who provided informed consent, met all eligibility criteria, and were enrolled in the study.|||Participants|||Count of Participants
2567280|NCT02569437|Secondary|Visual Analog Scale|The visual analog scale for overall symptoms will be used to define disease severity. Range of 0 to 10. As per the European Position Paper 2012, mild, moderate, and severe disease will be defined as 0 to and including 3, > 3 to and including 7, and > 7 to and including 10, respectively.|Baseline and 12 weeks|There were 12 subject withdrawals in the treatment group and 14 in the placebo group.|||units on a scale||Standard Deviation|Mean
2567281|NCT02569437|Secondary|Subjective Symptom Composite Scoring|"A subjective symptom score will be extracted from the patient's score (on a scale of 0-5, where 0 defines no problems with the given symptom and 5 defines maximal problems ) on the SNOT-22 for each fo the following symptoms: blockage/congestion, runny nose, post-nasal discharge, facial pain/pressure, and sense of taste/smell. Range of 0 to 25, with higher score reflecting worse symptoms."|Baseline and 12 weeks|There were 12 subject withdrawals in the treatment group and 14 in the placebo group.|||units on a scale||Standard Deviation|Mean
2567282|NCT02569437|Secondary|Middle Meatus Culture|Culture swab for the presence or absence of microbial growth|Baseline and 12 weeks||||Participants|||Count of Participants
2567283|NCT02569437|Secondary|Endoscopic Nasal Polyp Score|"0- Absence of nasal polyps~Polyps confined to the middle meatus and not beyond the inferior border of the middle turbinate~Polyps reaching below the lower border of the middle turbinate~Large polyps extending to the lower border of the inferior turbinate or medial to the middle turbinate~Large polyps extending to the lower border of the inferior turbinate or medial to the middle turbinate Nasal polyp scores. The score is determined for each nostril, and the two scores added for a total nasal polyp score. Range of 0 to 8, graded on a size system from 0 to 4 and summed from the right and left nostrils."|Baseline and 12 weeks|There were 12 subject withdrawals in the treatment group and 14 in the placebo group.|||units on a scale||Standard Deviation|Mean
2567284|NCT02569437|Primary|Sino-nasal Outcome Test (SNOT 22)|a validated 22 item quality of life questionnaire for patients with chronic rhinosinusitis. Range of 0 to 110, higher scores indicate worse outcome|Baseline and 12 weeks|An additional 7 patients in the treatment group and 10 patients in the placebo group completed SNOT-22 scores via phone calls, even after study withdrawal.|||units on a scale||Standard Deviation|Mean
2567286|NCT02569398|Secondary|Change From Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score at Endpoint (Month 24)|"The CDR-SB is an interviewer administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 6 individual category ratings, or box scores, were added together to give the CDR-Sum of Boxes which ranges from 0-18. Higher score indicates severe impairment."|Baseline and Endpoint (Month 24)|As the study was terminated early with lesser participants and lesser sample size, data for this endpoint was not collected and analyzed per change in planned analysis.||||||
2567287|NCT02569398|Secondary|Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score at Endpoint (Month 24)|RBANS is 20 to 25 minute battery developed for cognitive assessment, detection, and characterization of dementia. RBANS includes 12 subtests that measure following 5 indices: (1)Attention Index, composed of Digit Span and Coding; (2)Language Index, consisting of Picture Naming and Semantic Fluency subtests; (3)Visuospatial/Construction Index, made up of Figure Copy and Line Orientation subtests; (4)Immediate Memory Index, composed of List Learning and Story Memory subtests, and (5)Delayed Memory Index, consisting of List Recall, List Recognition, Story Recall, and Figure Recall subtests. Completion of RBANS yields 5 index scores based on participant performance on various subtests, as well as a composite Total Index score for battery. Total index scores range from 40 to 160, and are normalized to a mean of 100 and standard deviation (SD) of 15. Higher scores indicate less impairment.|Baseline and Endpoint (Month 24)|ITT analysis set included all randomized participants. Here ‘N’ (Number of participants analyzed) was defined as the number of participants evaluable at this outcome measure.|||Score on a scale||Standard Deviation|Mean
2567288|NCT02569398|Secondary|Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Prevention Instrument (ADCS-ADLPI) Total Score at Endpoint (Month 24)|"The Alzheimer's Disease Cooperative Study - Activities of Daily Living -Prevention Instrument (ADCS-ADLPI) is a functional measure composed of 18 items that includes 15 activities of daily living rated on a 4-point scale and 3 high level function items. Study participants and their informants independently rate the participant's level of ability (with no difficulty = 3, with some difficulty = 2, with a lot of difficulty = 1, did not do/don't know = 0). Informants are additionally asked to evaluate whether activities were completed less often, required more time to complete, and if any errors were made performing the task. High-level function items are rated as yes or no. The scores range from 0 to 45 with higher scores indicating less impairment. The total score is the sum of the scores of the 15 activities of daily living questions (range: 0-45) with higher scores indicating less impairment."|Baseline and Endpoint (Month 24)|ITT analysis set included all randomized participants. Here ‘n’ (number analyzed) was defined as the number of participants evaluable at specified category.|||Score on a Scale||Standard Deviation|Mean
2567289|NCT02569398|Secondary|Change From Baseline in Cognitive Function Index (CFI) Score at Endpoint (Month 24)|The CFI is a modified version of the Mail-in Cognitive Function Screening Instrument, a participant- and informant-reported outcome measure developed by the Alzheimer's Disease Cooperative Study (ADCS). This assessment includes 15 questions (14 of which contribute to the total score, and 1 additional unscored item) that assess the participant's perceived ability to perform high-level functional tasks in daily-life and sense of overall cognitive functional ability. Study participants and their informants independently rate the participant's abilities. A participant-reported and an informant-reported total score is calculated which ranges from 0 to 14 (yes=1; no=0; maybe=0.5 for each question) with higher scores indicating greater impairment.|Baseline and Endpoint (Month 24)|ITT analysis set included all randomized participants. Here 'N' (number of Participants Analyzed) indicates the number of participants analyzed at this outcome measure and ‘n’ (number analyzed) was defined as the number of participants evaluable at specified category.|||Score on a scale||Standard Deviation|Mean
2567290|NCT02569398|Primary|Change From Baseline in Preclinical Alzheimer Cognitive Composite (PACC) Score at Endpoint (Month 24)|PACC has 4 components: Free and Cued Selective Reminding Test (0 (worst)-48 (best recall); Delayed Paragraph Recall test (Range 0 (worst)-25 (best recall); Wechsler Adult Intelligence scale: (ranges 0 [none]-135 [best performance]) and Mini Mental State Examination (Range 0 [worst] - 30 [best performance]). Component scores are transformed using an established normalization method into z-scores. Each of 4 component change scores is divided by baseline sample standard deviation (SD) of that component. These z scores are summed to form the composite score. Thus, a change of 1 baseline standard deviation on each component would correspond to a 4-point change on the composite. A z-score of 0 is equal to the mean and implies how many SD higher or lower score as compared with baseline score, with increase signifying improvement.|Baseline and Endpoint (Month 24)|Intent to treat (ITT) analysis set (all randomized participants) with participants in whom PACC change score is non-missing at greater than or equal to (>=) 1 post-baseline time point.|||z-score||Standard Deviation|Mean
2567291|NCT02569112|Primary|General Improvement in Skin Laxity of the Flank Area|Independent reviewer to identify the six month post-treatment photograph of the flank area treated with multi-polar radiofrequency, pulsed electro-magnetic fields and vacuum suction using the Global Aesthetic Improvement Scale (GAIS) where 3 = very much improved, 2 = much improved, 1 = improved, 0 = no change, -1 = worse, -2 = Much worse and -3 = very much worse.|6 months||||units on a scale|flank|Standard Deviation|Mean
2567292|NCT02569086|Primary|50% f T>MIC: Free Piperacillin Concentration Maintained at a Level Four Times Above the MIC 50% of the Dosing Interval.|The piperacillin plasma concentration-time profiles were best described by a two-compartment model. Each individual model predicted T>MIC was compared to clinical breakpoint MIC for P.aeruginosa (16 mg/L). The number of patients who achieved the pre-defined PK/PD target were reported.|Participants will be followed to day five (120 hours) after initiation of piperacillin/tazobactam treatment.||||participants|||Number
2567293|NCT02569086|Primary|100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval.|The piperacillin plasma concentration-time profiles were best described by a two-compartment model. Each individual model predicted T>MIC was compared to clinical breakpoint MIC for P.aeruginosa (16 mg/L). The number of patients who achieved the pre-defined PK/PD target were reported.|Participants will be followed to day five (120 hours) after initiation of piperacillin/tazobactam treatment.||||participants|||Number
2567294|NCT02568852|Secondary|Thrombin Time(TT)|measures of the extrinsic and intrinsic pathway of coagulation|Post-operative 24th hours|All patients have gall bladder disease who are between 18-80 years old.|||seconds||Standard Deviation|Mean
2567302|NCT02568852|Secondary|D-Dimer|A fibrin degradation product (or FDP) present in the blood after a blood clot is degraded by fibrinolysis|pre-operative|All patients have gall bladder disease who are between 18-80 years old.|||mg/L||Standard Deviation|Mean
2567303|NCT02568852|Secondary|PT(Prothrombin Time)|measures of the extrinsic pathway of coagulation|Post-operative 24th hours|All patients have gall bladder disease who are between 18-80 years old.|||seconds||Standard Deviation|Mean
2567304|NCT02568852|Secondary|PT(Prothrombin Time)|measures of the extrinsic pathway of coagulation|Post-operative 1st hour||||seconds||Standard Deviation|Mean
2567305|NCT02568852|Secondary|PT(Prothrombin Time)|measures of the extrinsic pathway of coagulation|pre-operative|All patients have gall bladder disease who are between 18-80 years old.|||seconds||Standard Deviation|Mean
2567306|NCT02568852|Secondary|Fibrinogen Level|A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation|Post-operative 24th hour|All patients have gall bladder disease who are between 18-80 years old.|||mg/dL||Full Range|Median
2567307|NCT02568852|Secondary|Fibrinogen Level|A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation|Post-operative 1 st hour|All patients have gall bladder disease who are between 18-80 years old.|||mg/dL||Full Range|Mean
2567308|NCT02568852|Secondary|Fibrinogen Level|A soluble plasma glycoprotein, that is converted by thrombin into fibrin during blood clot formation|pre-operative|All patients have gall bladder disease who are between 18-80 years old.|||mg/dL||Full Range|Mean
2567309|NCT02568852|Primary|Duration of Operation|group1 and group 2(Duration of Operation)|up to 2 hours|All patients have gall bladder disease who are between 18-80 years old.|||minutes||Full Range|Mean
2567310|NCT02568683|Secondary|Number of VCR Doses||Baseline to end of study (maximum: 24 weeks)|Participants in the Full Analysis Set were analyzed.|||doses||Standard Deviation|Mean
2567311|NCT02568683|Secondary|Duration of Exposure to ENTO||Baseline to end of study (maximum: 24 weeks)|Participants in the Full Analysis Set were analyzed.|||weeks||Standard Deviation|Mean
2567312|NCT02568683|Secondary|Number of Participants With AEs and Lab Abnormalities Not Defined as DLTs in Participants With Relapsed or Refractory B-cell NHL: Dose Escalation Stage|The number of participants with AEs and lab abnormalities not defined as DLTs in participants in the dose escalation stage with relapsed or refractory B-cell NHL are presented.|Cycle 1 (28-day cycle)|Participants in the Full Analysis Set were analyzed.|||Participants|||Count of Participants
2567313|NCT02568683|Primary|Number of Participants With Adverse Events (AEs) and Laboratory (Lab) Abnormalities Defined as Dose Limiting Toxicities (DLTs) in Participants With Relapsed or Refractory B-cell NHL: Dose Escalation Stage|"Occurrence of any of the following toxicities during Cycle 1 was considered DLT if judged by the Investigator to be possibly, probably, or definitely related to the administration of any drug in the treatment regimen:~Grade 4 (or higher) non-hematologic toxicity~Grade 3 non-hematologic toxicity lasting ≥ 7 days despite optimal supportive care~Note: Grade 3 or higher neuropathy was considered DLT if occurring during Cycle 1 regardless of duration.~Any Grade 3 non-hematologic laboratory value if:~Medical intervention was required to treat the patient, or~Abnormality led to hospitalization, or~Abnormality persisted for > 1 week~Grade 4 Neutropenia (absolute neutrophil count [ANC] < 500 /μL) persisting for > 14 days or associated with febrile neutropenia~Grade 4 thrombocytopenia (platelets < 25,000 cells/μL) persisting for > 14 days (or > 25,000 cells/μL, but requiring prophylactic platelet transfusion to maintain this level)"|Cycle 1 (28-day cycle)|DLT Analysis Set included participants in the Full Analysis Set (included all participants who received at least 1 dose of ENTO) who received 37 of 56 Cycle 1 doses of ENTO and completed the full Cycle 1 dose of VCR or who experienced a DLT during the DLT assessment window.|||Participants|||Count of Participants
2567314|NCT02568644|Secondary|Change in Serum Levels of Biomarkers.|Evaluated biomarkers: neurotrophic factors and inflammatory mediators.|2 hours|Brain derived neurotrophic factor - BDNF (pg/mL)|||BDNF (pg/mL)||95% Confidence Interval|Median
2567315|NCT02568644|Primary|Change in Headache Severity.|"The severity of headache was assessed with faces pain scale. It is a self-reported pain scale consisting of face drawings which have a score ranging from zero (absence of pain) to five (maximal intensity of pain).~Higher scores mean a worse outcome."|2 hours||||units on a scale||Standard Deviation|Mean
2567316|NCT02568644|Primary|Change in Headache Severity.|The severity of headache was assessed with visual numeric scale. Scale ranges: from zero (absence of pain) to 10 (maximum intensity of pain). Higher scores mean a worse outcome.|2 hours||||units on a scale||Standard Deviation|Mean
2567317|NCT02568644|Primary|Change in Headache Severity.|The severity of headache was assessed with four-point scale. Scale ranges: 0 - Absence of pain, 1 - Mild Pain, 2 - Moderate Pain and 3 - Severe pain Higher scores mean a worse outcome|2 hours||||units on a scale||Standard Deviation|Mean
2567318|NCT02568397|Secondary|Pharmacodynamics: Ratio of Maximum Effect to Baseline Effect (ERmax) of Thrombin Time|Ratio of maximum effect to baseline effect following administration of 150 mg dabigatran etexilate alone on Day 1, 50 mg LY3314814 and 150 mg dabigatran dosed concurrently on Day 16, and 50 mg LY3314814 and 150 mg dabigatran (dosed 4 hours later) on Day 20|Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose|All participants who received at least one dose of study drug and had evaluable Pharmacodynamic (PD) data.|||ratio of maximum effect||Full Range|Median
2567319|NCT02568397|Secondary|Pharmacodynamics: Area Under the Effect Versus Time Curve (AUEC) of Thrombin Time||Days 1, 16 and 20: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose|All participants who received at least one dose of study drug and had evaluable Pharmacodynamic (PD) data.|||seconds*hour (s*h)||Standard Deviation|Mean
2567320|NCT02568397|Secondary|Pharmacokinetics: Area Under the Lanabecestat Pharmacokinetic (PK) Concentration Versus Time Curve During One Dosing Interval (24 Hours) (AUCtau)||Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose|All participants who received one dose of study drug and had evaluable PK data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2567321|NCT02568397|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Lanabecestat||Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose|All participants who received one dose of study drug and had evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2567339|NCT02568007|Secondary|Anthropometrics: Mid-arm Circumference|Change in mid-arm circumference as measure by centimeters and z-score percentiles|two months|Too few patients to be analyzed||||||
2567322|NCT02568397|Primary|Pharmacokinetics: Area Under The Dabigatran Pharmacokinetic (PK) Concentration Versus Time Curve From Zero to Infinity (AUC[0-infinity)||Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose|All participants who received at least one dose of study drug and had evaluable PK data.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2567323|NCT02568397|Primary|Pharmacokinetics (PK) : Maximum Concentration (Cmax) of Dabigatran||Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 36 hours postdose|All participants who received at least one dose of study drug and have evaluable pharmacokinetic (PK) data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2567324|NCT02568384|Other Pre-specified|Average Change in Total Daily Insulin Dose From Study Start to End of Study|Subjects' self-reported Total Daily Insulin Doses at visit 1 were compared with their self-reported Total Daily Insulin Doses at Visit 2 (end of study).|3 weeks||||insulin units||Full Range|Mean
2567325|NCT02568384|Other Pre-specified|Average Change in Subject Body Weight From Study Start to End of Study|Subject Body Weight results at visit 1 were compared with Body Weight results at Visit 2 (end of study).|3 weeks||||pounds||Full Range|Mean
2567326|NCT02568384|Other Pre-specified|Average Change in Subject Fructosamine From Study Start to End of Study|Laboratory reports were used to compare Fructosamine results from subjects at visit 1 with Fructosamine results at Visit 2 (end of study).|3 weeks|Change in umol/L|||umol/L||Full Range|Mean
2567327|NCT02568384|Other Pre-specified|HbA1c% From Study Start to End of Study|Laboratory reports were used to compare HbA1c results from subjects at visit 1 with HbA1c results at Visit 2 (end of study).|3 weeks|Change in %HbA1c.|||%HbA1c||Full Range|Mean
2567328|NCT02568384|Secondary|Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neither Agree Nor Disagree' With Questionnaire Statements Regarding Clarity and Utility of User Instructions For Onyx Glucose Meter and App System|Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the clarity and utility of user instructions for the Onyx Glucose Meter and App System. Subjects could respond '1Strongly Agree' or '2Agree' or '3Neither Agree nor Disagree' or '4Disagree' or '5Strongly Disagree' or '6No Opinion'.|3 weeks|While 43 subjects completed the questionnaire, responses with 'No opinion' were not counted in the total used to calculate percent of responses for each statement.|||percentage of responses <or = 3|||Number
2567329|NCT02568384|Secondary|Percent of Responses From Persons With Diabetes That Rated Ease of Use For Onyx Glucose Meter and App System as Either Very Simple or Simple or Neither Simple Nor Difficult|Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on the basic operation of the Onyx Glucose Meter and App System. Subjects could respond '1Very Simple' or '2Simple' or '3Neither Simple nor Difficult' or '4Difficult' or '5Very Difficult' or '6No Opinion'.|3 weeks|While 43 subjects completed the questionnaire, responses with 'No opinion' were not counted in the total used to calculate percent of responses for each statement.|||Percentage of Responses|||Number
2567330|NCT02568384|Primary|"Percent of Responses From Persons Who Performed Each Software Operations Task and Rated Each Statement as Strongly Agree, Agree, or Neither Agree Nor Disagree."|"For software operations tasks, subjects rated statements about software operations tasks as 1Strongly Agree, 2Agree, 3Neither Agree nor Disagree, 4Disagree, 5Strongly Disagree, or 6No opinion. Software operations tasks included:~Obtain a synced blood glucose reading~Initiation and use of insulin bolus calculator~Access and interpret glucose displays such as expanded graph (modal day) and sequential views."|3 weeks|While 43 subjects completed the questionnaire, responses with 'No opinion' were not counted in the total used to calculate percent of responses for each statement.|||Percent of Responses|||Number
2567331|NCT02568345|Primary|Sugammadex ED90|"Complete reversal of neuromuscular blockade occured when the patient had a TOF T4/T1 ≥ 0.9 within eight minutes of sugammadex infusion.~The sequencial design method of up-and-down was applied to determine the minimum effective dose in 90% of patients (ED90). An effective dose is one that achieves complete reversal of neuromuscular blockade that is defined as a measure of TOF equal or higher than 0.9, or a relationship between T4 an T1 measure ≥ 0.9, within eight minutes of sugammadex infusion."|8 minutes||||mg/kg||99% Confidence Interval|Number
2567332|NCT02568254|Primary|Overall Comfort|Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|2- Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Units on a scale||Standard Deviation|Mean
2567333|NCT02568046|Primary|Number of Participants With Adverse Events (AEs) by Nature, Severity, and Occurrence Measured From Baseline to End of Trial Participation, as Assessed by the Common Terminology Criteria for AEs (Version 4.03) (CTCAE v4.03).|AEs were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. The incidence and type of AEs (e.g., treatment-emergent AE [TEAE]) were summarized according to MedDRA system organ classes and preferred terms. An AE was considered as treatment-emergent if it occurred after the first treatment administration.|15 months|All safety analyses were conducted using the Full Analysis Set (FAS) population, defined as all patients who received at least 1 dose of trial treatment.|||Participants|||Count of Participants
2567334|NCT02568007|Secondary|24 Hour Diet Recall|Change in calorie intake will be recorded|two months|Too few patients to be analyzed||||||
2567335|NCT02568007|Secondary|Percentage of Participants Experiencing Side Effects From Cyproheptadine|Patients will answer affirmative or negative to a descriptive list of side effects commonly experienced when taking cyproheptadine. Examples of these descriptive variables include nausea, emesis, etc. Percentage of patients experiencing each side effect will be calculated and compared across the course of study.|two months|Too few patients to be analyzed||||||
2567336|NCT02568007|Secondary|Anthropometrics: Weight|Change in weight as measured in kilograms and z-score percentiles|two months|Too few patients to be analyzed||||||
2567337|NCT02568007|Secondary|Anthropometrics: Height|Change in height as measured in centimeters and z-score percentiles|two months|Too few patients to be analyzed||||||
2567338|NCT02568007|Secondary|Anthropometrics: BMI|Change in BMI as measured by kilograms divided by meters squared and z-score percentiles|two months|Too few patients to be analyzed||||||
2567341|NCT02568007|Primary|Feeding Behavior Questionnaire|"Participants' guardians will complete the Mealtime Behavior Questionnaire (MBQ). This is a validated, 31-item, parent-report questionnaire assessing the mealtime behavior structure in young children above 2 years. The questionnaire measures variables including: 1) food refusals/avoidance; 2) food manipulation; 3) mealtime aggression and 4) choking/gagging/vomiting related to meals. Each behavior is assigned a frequency scale with 1 corresponding to never and 5 corresponding to always. The MBQ then consist of a total score and four subcategory scores (listed above)."|two months|Too few patients to analyze||||||
2567342|NCT02567968|Secondary|Heart Rate|This measurement was made in order to determine whether caffeine altered heart rate in a deleterious manner.|Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.||||beats per minute||Standard Deviation|Mean
2567343|NCT02567968|Secondary|Mean Arterial Blood Pressure|This measurement was made in order to determine whether caffeine altered blood pressure in a deleterious manner.|Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.||||mmHg||Standard Deviation|Mean
2567344|NCT02567968|Secondary|Minute Ventilation|The volume of gas inhaled or exhaled from a person's lungs per minute. We wished to determine whether caffeine altered minute ventilation.|Continuous monitoring from time lma inserted until subject started to gag and it was removed, up to 2 hours post-anesthesia.||||L/minute||Standard Deviation|Mean
2567345|NCT02567968|Secondary|Bispectral Index|A bispectral index (BIS) measurement system was employed to measure depth of anesthesia. Using electrodes attached to the forehead to measure EEG, BIS outputs a dimensionless number between 0 and 100 that is proportional to the brain concentration of anesthetic and is thereby proportional to an individual's level of consciousness (Greenwald S, Chiang HH, Devlin P, Smith C, Sigl J, Chamoun N: The Bispectral Index (Bis2.0) as a Hypnosis Measure. Anesthesiology 1994; 81: A477-a477). When the test subjects arrive, prior to anesthesia, their BIS values are in the range of 95 - 99. That corresponds to an awake and alert state. During anesthesia, most subjects are in the range of 20 - 40, corresponding to an anesthetized state. As the anesthetic wears off, the BIS values rise until they are back in the 95 - 99 range that they were prior to anesthesia. In particular, we wished to determine whether BIS exhibited more rapid recovery after caffeine infusion as compared to saline (control).|Continuous monitoring from start of anesthesia until discharge of test subject, up to 2 hours post-anesthesia.|One subject was missing data at the last timepoint for the Placebo session|||units on a scale||Standard Deviation|Mean
2567346|NCT02567968|Secondary|Cognitive Test3 - Divided Attention Task|Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. The test was first applied at 15 minutes following anesthesia, if the subject was awake and then repeated every 15 minutes. In the Divided Attention Task (DAT), participants were asked to fly an airplane over the center of a winding road with a joystick and simultaneously press a button whenever targets randomly flashed on the screen. The computer program tracked the root mean squared (RMS) deviation of the plane from the center of the road and the latency for pressing the trigger when the target appeared.|Test was given at 15, 30, 45, 60 minutes after terminating anesthesia.|Some participants could not be tested at the early timepoints due to not being fully awake etc.|||mm away from optimal||Standard Deviation|Mean
2567347|NCT02567968|Secondary|Cognitive Test2 - Sternberg Test of Memory|Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. The test was first applied at 15 minutes following anesthesia, if the subject was awake and then repeated every 15 minutes. In the Sternberg Test of Memory (STM) participants were asked to memorize a string of numbers. Afterwards, a computer would flash a series of random numbers on the screen and the participant was asked whether the number on the computer screen was part of the earlier string or not. In three rounds, participants were given a string of 2, then 4, then 6 numbers. The latency until the subject answered the question was monitored and this is the data summarized here.|Test was given at 15, 30, 45, 60 minutes after terminating anesthesia.|Some participants could not be tested at the early timepoints due to not being fully awake etc.|||ms||Standard Deviation|Mean
2567348|NCT02567968|Secondary|Cognitive Test1 - Visual Analog Scale --- Feel Bad|"Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. Fifteen minutes after terminating anesthesia each subject was asked to complete a series of psychomotor tests, if they were able. Otherwise the testing started at 30 minutes. The tests were repeated every 15 minutes. The first test, a visual analog scale (VAS) test consisted of two 100-mm lines, each labelled with of feel good or feel bad displayed on a computer screen. Test subjects were asked to rate how they currently felt by placing a cursor on each of the line (0=not at all, 100=extremely). The test repeated every 15 minutes."|Test was given at 15, 30, 45, 60, 75, 90, 105 and 120 minutes after terminating anesthesia.|Some participants could not be tested at the early timepoints due to not being fully awake etc.|||units on a scale||Standard Deviation|Mean
2567349|NCT02567968|Secondary|Cognitive Test1 - Visual Analog Scale --- Feel Good|"Normally patients receiving anesthesia exhibit significant cognitive problems for hours after anesthesia is terminated. The goal is to determine whether caffeine helps ameliorate the cognitive issues. Fifteen minutes after terminating anesthesia each subject was asked to complete a series of psychomotor tests, if they were able. Otherwise the testing started at 30 minutes. The tests were repeated every 15 minutes. The first test, a visual analog scale (VAS) test consisted of two 100-mm lines, each labelled with of feel good or feel bad displayed on a computer screen. Test subjects were asked to rate how they currently felt by placing a cursor on each of the line (0=not at all, 100=extremely). The test repeated every 15 minutes."|Test was given at 15, 30, 45, 60, 75, 90, 105 and 120 minutes after terminating anesthesia.|Some participants could not be tested at the early timepoints due to not being fully awake etc.|||units on a scale||Standard Deviation|Mean
2567372|NCT02567656|Primary|Safety of RP6530|Number of participants with Treatment-Related Adverse Events as Assessed by CTACE v4.0|28 days|DLT assessment performed in patients who participated in dose escalation phase; A toxicity will be considered dose-limiting if it occurs during the first cycle (4-weeks) treatment with Tenalisib and is considered related to Tenalisib.|||Participants|||Count of Participants
2571686|NCT02513732|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|0 to 4 years|ITT population|||Participants|||Count of Participants
2567350|NCT02567968|Primary|Waking Time - Re-establishment of the Gag Reflex.|"The goal of the study is to determine whether caffeine speeds emergence from anesthesia. The time between terminating delivery of anesthetic and the subject starting to gag was measured. Anesthesia suppresses the gag reflex. Immediately after anesthetizing the test subject, a laryngeal mask airway (LMA) device was inserted into the test subject airway. After anesthesia was terminated and emergence from anesthesia was taking place, the gag reflex was re-established, and the LMA produced a gag response in all test subjects. This objective and unequivocal measurement constituted the emergence time for each subject. The emergence time was defined as the time between terminating the anesthesia and the test subject starting to gag."|followed from the end of anesthesia to gag reflex, up to 2 hours||||minutes||Standard Deviation|Mean
2567351|NCT02567708|Secondary|Plasma Concentration of GSK2269557|Blood samples were collected from participants for pharmacokinetic (PK) analysis at Day 7, Day 14 and Day 28 pre dose. On Day 28 samples were also collected between 5-10 minutes post dose and between 2.5-3.5 hours post dose. The analysis was performed on PK Population which comprised of participants in the ITT Population for whom a PK sample was obtained and analyzed. The number of participants with data available at the specified data points are represented by n= X in the category titles.|Pre dose at Day 7 and Day 14. At Day 28 pre dose, 5-10 minutes and 2.5-3.5 hours post dose|PK Population|||Picograms per Milliliter (Pg/mL)||95% Confidence Interval|Geometric Mean
2567352|NCT02567708|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Single measurements of 12-lead ECGs were obtained after 5 minutes rest in a semi-supine position at Baseline (Day 1 pre dose) , Day 7, Day 28 pre-dose in each treatment period using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc). ECG values were recorded as abnormal not clinically significant (NCS) and abnormal clinically significant (CS). The number of participants with data available at the specified data points are represented by n= X in the category titles.|Up to Day 28 for each treatment period|Safety Population|||Participants|||Number
2567353|NCT02567708|Secondary|Number of Participants With Abnormal Vital Sign Values|Number of participants with abnormal values of vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate were evaluated. Vital signs outside the range of potential clinical importance are presented at the indicated timepoints: Day 7, Day 14, Day 28 and follow-up/Early withdrawal. The number of participants with data available at the specified data points are represented by n=X in the category titles.|From start of IP up to Week 14|Safety Population|||Participants|||Number
2567354|NCT02567708|Secondary|Number of Participants With Abnormal Values of Hematology Parameters|Blood samples were collected from participants for evaluation of hematology parameters by Potential Clinical Importance Criteria. The hematology parameters included hematocrit, hemoglobin, lymphocytes, total neutrophils, platelets and white blood cells (WBC). Participants were counted in the category that their value changes to (low, normal or high), unless there is no change in their category. The number of participants with data available at the specified data points are represented by n=X in the category titles.|From start of IP up to Week 14|Safety Population|||Participants|||Number
2567355|NCT02567708|Secondary|Number of Participants With Abnormal Values of Clinical Chemistry Parameters|Blood samples were collected from participants for evaluation of clinical chemistry parameters by Potential Clinical Importance Criteria. The clinical chemistry parameters included albumin, calcium, creatinine, glucose, potassium and sodium. Participants were counted in the category that their value changes to (low, normal or high), unless there is no change in their category. The number of participants with data available at the specified data points are represented by n=X in the category titles.|From start of IP up to Week 14|Safety Population|||Participants|||Number
2567356|NCT02567708|Secondary|Number of Participants With On-treatment Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The analysis was performed on Safety Population which comprised of all participants who were randomized into the study.|From the Start of IP up to Week 14|Safety Population|||Participants|||Number
2567357|NCT02567708|Secondary|Percentage of Rescue Free Days Over the Treatment Period|Daily recordings of rescue medication use were collected in an eDiary by participants. Percentage of rescue free days was calculated as the number of rescue free days divided by length of treatment period.|Up to Day 28 for each treatment period|ITT Population.|||Percentage of days||Standard Deviation|Mean
2567358|NCT02567708|Secondary|Mean Number of Inhalations Per Day of Rescue Medication (Salbutamol) Over the Treatment Period|Daily recordings of rescue medication use were collected in an eDiary by participants. The mean number of inhalations per day of rescue medication was calculated for each participant as number of inhalations over the time period of interest divided by number of days when rescue medication was taken over the time period of interest.|Up to Day 28 for each treatment period|ITT Population. Only those participants with data available at specified time point were analyzed.|||Inhalations/day||Standard Deviation|Mean
2567359|NCT02567708|Secondary|Change From Baseline in Trough Fractional Exhaled Nitric Oxide (FeNO) at Day 7, Day 14 and Day 28|Participants with asthma have high levels of NO in their exhaled breath. Evaluation of FeNO is a quantitative, noninvasive method of measuring airway inflammation to assess airway diseases including asthma. FeNO was measured in the clinic using a handheld electronic device. Change from Baseline for Day 7, Day 14 and Day 28 was calculated as the post-Baseline value minus the Baseline value where Baseline was defined as Day 1 (pre-dose). The number of participants with data available at the specified time points are represented by n=X in the category titles.|Baseline, Day 7, Day 14 and Day 28 for each treatment period|ITT Population.|||Part per billion (PPB)||95% Confidence Interval|Median
2567360|NCT02567708|Secondary|Change From Baseline in Daily Peak Expiratory Flow (PEF) Averaged Over the Treatment Period|Triplicate measurements of PEF were collected in an eDiary pre-dose before breakfast (AM), and approximately 12 hours later at evening (PM). The average change from Baseline was calculated by summing the total value of the endpoint (i.e. change from Baseline) within the time period of interest and dividing by the number of days with non-missing data for that endpoint to obtain an average for each subject. The AM Baseline is the Day 1 AM value, the PM Baseline is the last PM reading prior to taking the first dose of blinded study medication within that Treatment Period. The number of participants with data available at the specified time points are represented by n=X in the category titles.|Baseline and up to Day 28 for each treatment period|ITT Population|||Liter/minute||Standard Deviation|Mean
2567361|NCT02567708|Secondary|Change From Baseline in Daily FEV1 Averaged Over the Treatment Period|Triplicate measurements of FEV1 were collected in an eDiary pre-dose before breakfast [ante meridiem (AM)], and approximately 12 hours later at evening [post-meridiem (PM)]. The average change from Baseline was calculated by summing the total value of the endpoint (i.e. change from Baseline) within the time period of interest and dividing by the number of days with non-missing data for that endpoint to obtain an average for each subject. The AM Baseline is the Day 1 AM value, the PM Baseline is the last PM reading prior to taking the first dose of blinded study medication within that Treatment Period. The number of participants with data available at the specified time points are represented by n=X in the category titles.|Baseline and up to Day 28 for each treatment period|ITT Population.|||Liter||Standard Deviation|Mean
2567362|NCT02567708|Secondary|Change From Baseline in Asthma Control Test (ACT) Score at Day 28|The total ACT score is the sum of five-item questionnaires developed as a measurement of asthma control. Total score can range from five (worse control) to 25 (full control), with higher scores reflecting greater asthma control. Total ACT score at Day 1 (Baseline) and Day 28 in both Treatment Periods was used for this analysis. Change from Baseline in ACT was calculated as post-Baseline value minus Baseline value where Baseline was defined as Day 1 (pre-dose).|Baseline and Day 28 for each treatment period|ITT Population. Only those participants with data available at specified time point were analyzed.|||Score on a scale||95% Confidence Interval|Median
2567363|NCT02567708|Secondary|Change From Baseline in FEV1/FVC at Day 7, Day 14 and Day 28|FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the total amount of air exhaled during the FEV test. Change from Baseline in FEV1/FVC at Day 7, Day 14 and Day 28 was calculated as post-Baseline value minus Baseline value where Baseline was defined as Day 1 (pre-dose). The number of participants with data available at the specified time points are represented by n=X in the category titles.|Baseline, Day 7, Day 14 and Day 28 for each treatment period|ITT Population.|||Percentage of exhaled air||95% Confidence Interval|Median
2567364|NCT02567708|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Day 7, Day 14 and Day 28|FVC is defined as the total amount of air exhaled during the FEV test. Data was collected pre-dose at Baseline (Day 1), Day 7, Day 14 and Day 28. Change from Baseline was calculated as the post-Baseline value minus the Baseline value where Baseline was defined as Day 1 (pre-dose). The number of participants with data available at the specified time points are represented by n=X in the category titles.|Baseline, Day 7, Day 14 and Day 28 for each treatment period|ITT Population.|||Liter||95% Confidence Interval|Median
2567365|NCT02567708|Secondary|Change From Baseline in Trough FEV1 at Day 7 and Day 14|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The trough FEV1 is the maximum volume of air that can be forced out in one second after taking a deep breath approximately 24 hrs after the last administration of study drug. Change from Baseline values were calculated as post-Baseline values minus Baseline value where Baseline was defined as Day 1 (pre-dose). The number of participants with data available at the specified time points are represented by n=X in the category titles.|Baseline, Day 7 and Day 14 for each treatment period|ITT Population.|||Liters||95% Confidence Interval|Median
2567366|NCT02567708|Secondary|Weighted Mean (0-4 Hours) FEV1 at Day 28|The weighted mean FEV1 on Day 28 was calculated using data collected pre-dose and at 1 hour, 2 hours, 3 hours, and 4 hours post-dose. The weighted mean FEV1 was derived by calculating the average area under the curve using the trapezoidal rule, and then dividing by the relevant time interval.|Day 28 for each treatment period|ITT Population. Only those participants with data available at specific time point were analyzed.|||Liters||95% Confidence Interval|Median
2567367|NCT02567708|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 in Per Protocol (PP) Population|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is the maximum volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug. FEV1 was measured using a spirometer. Change from Baseline is calculated as post-Baseline value minus Baseline value where Baseline is defined as Day 1 (pre-dose). The analysis was performed on the PP Population which comprised of all participants in the ITT Population not identified as major protocol violators.|Baseline and Day 28 for each treatment period|PP Population|||Liters||95% Confidence Interval|Median
2567368|NCT02567708|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 in Intent-To-Treat (ITT) Population|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is the maximum volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug. FEV1 was measured using a spirometer. Change from Baseline is calculated as post-Baseline value minus Baseline value where Baseline is defined as Day 1 (pre-dose).|Baseline and Day 28 for each treatment period|The analysis was performed on the ITT Population which comprised of all participants who received at least one dose of trial medication and have at least one post-dose efficacy assessment. Six participants had entered the study without spirometric evidence of disease, and were excluded from the ITT population prior to unblinding.|||Liters||95% Confidence Interval|Median
2567369|NCT02567656|Secondary|Peak Plasma Concentration (Cmax)|Peak Plasma Concentration (Cmax) of RP6530|Day 1 of Cycle 1|Peak Plasma Concentration (Cmax) of RP6530 at Cycle 1 day 1|||ng/mL||Standard Deviation|Mean
2567370|NCT02567656|Secondary|Duration of Response (DOR) With RP6530|The time period from the response achieved in patient until the disease progression.|24 months|Duration of Response (DoR) is defined as the time when the measurement criteria are first met for PR or CR (whichever is reported first) until the date of documented disease progression or death. Overall number of Participants analyzed for DoR will be the participants who met response as CR or PR|||Days||Full Range|Median
2567371|NCT02567656|Secondary|Overall Response Rate (ORR) With RP6530|ORR is defined as sum of CR and PR rates, Response assessment for PTCL based on IWG criteria (Cheson 2007) and CTCL on mSWAT/Global assessment (ISCL/EORTC guideline).|8 months|Patients were considered for efficacy analysis as per protocol only if they had one post treatment efficacy assessment at C3D1|||Participants|||Count of Participants
2567398|NCT02567188|Primary|Mean Hb Value at Month 3 Before Inclusion||Pre-baseline (Month -3)|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||gm/L||Standard Deviation|Mean
2567373|NCT02567552|Primary|Endometrial Gene Expression Difference|Genes with a significantly high gene expression difference (adj-p-value < 0.05, Fold Change>3)|5 days|We assessed the expressed genes with a significantly high gene expression difference between treatments (adj-p-value < 0.05, Fold Change>3) This analysis could not be performed in 1 patient of the prolutex group because of the poor quality of the sample collected|||Endometrial genes|Endometrial genes||Number
2567374|NCT02567552|Secondary|Number of Participants With Side Effects During the Study|"Number of Participants with side effects during the study"|5 days||||participants|||Number
2567375|NCT02567552|Secondary|Blood LH Level|Blood Luteinizing hormone level 5 days after progesterone treatment|5 days||||pg/mL||Standard Deviation|Mean
2567376|NCT02567552|Secondary|Blood Progesterone Level|Blood progesterone level 5 days after progesterone treatment|5 days||||ng/mL||Standard Deviation|Mean
2567377|NCT02567552|Secondary|Blood Estradiol Level|Blood estradiol level 5 days after progesterone treatment|5 days||||pg/mL||Standard Deviation|Mean
2567378|NCT02567552|Secondary|Blood LH Level|Blood Luteinizing hormone level on the day of follicular puncture|day 0||||pg/mL||Standard Deviation|Mean
2567379|NCT02567552|Secondary|Blood Progesterone Level|Blood progesterone level on the day of follicular puncture|day 0||||ng/mL||Standard Deviation|Mean
2567380|NCT02567552|Secondary|Blood Estradiol Level|Blood estradiol level on the day of follicular puncture|day 0||||pg/mL||Standard Deviation|Mean
2567381|NCT02567552|Secondary|Endometrial Thickness|Endometrial thickness measurement by means of transvaginal ultrasound.|5 days||||mm||Standard Deviation|Mean
2567382|NCT02567552|Primary|Endometrial Gene Expression|Gene expression profile of endometrial|5 days|"We assessed the gene expression of 238 endometrial genes to detect differences in gene expression between treatments.~This analysis could not be performed in 1 patient of the prolutex group because of the poor quality of the sample collected"|||Endometrial genes|Endometrial genes||Number
2567383|NCT02567552|Primary|Endometrial Maturation Using Noyes' Criteria|Endometrial dating of luteal phase days according to the Noyes criteria|5 days||||days||Standard Deviation|Mean
2567384|NCT02567552|Primary|Decidualization of Stromal Cell|Rate of transformation of endometrial stromal fibroblasts into specialized secretory decidual cells (three categories: less than 25%, between 26% and 50%, and over 50%)|5 days||||participants|||Number
2567385|NCT02567552|Primary|Predecidual Transformation|Histologic dating of the endometrium at day 5: early secretory phase, media secretory phase or late secretory phase|5 days||||participants|||Number
2567386|NCT02567188|Secondary|Percentage of Participants Who Required Renal Replacement Therapy|Renal replacement therapy was defined as hemodialysis and peritoneal dialysis.|Months 3, 6, 9, and 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure and n= participants evaluable for specified time points.|||percentage of participants|||Number
2567387|NCT02567188|Secondary|Percentage of Participants Who Required Blood Transfusion||Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure and n= participants evaluable for specified time points.|||percentage of participants|||Number
2567388|NCT02567188|Secondary|Number of Participants With Different Medication Treatment|Number of participants who were receiving different treatments (antihypertensive, immunosuppressive, iron supplements, and others) before and/or after baseline were reported. Same participant could be reported in more than one category.|Pre-baseline (Month -6) to Month 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure.|||participants|||Number
2567389|NCT02567188|Secondary|Percentage of Participants With Changes in AntihypertensiveTreatment|Percentage of participants who had any change in their antihypertensive medication at a specified visit were reported.|Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12|All enrolled participants. Here, number of participants analyzed = participants evaluable for this outcome measure and n= participants evaluable for specified time points.|||percentage of participants|||Number
2567390|NCT02567188|Secondary|Percentage of Participants With Changes in Immunosuppressive Treatment|Percentage of participants who had any change in their immunosuppressive medication at a specified visit were reported.|Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12|All enrolled participants. Here, number of participants analyzed = participants evaluable for this outcome measure and n= participants evaluable for specified time points.|||percentage of participants|||Number
2567391|NCT02567188|Primary|Percentage of Participants With Hb Fluctuation From Baseline to Month 12|Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits.|Baseline to Month 12|All enrolled participants. Here, number of participants analyzed= participants with at least 2 non-missing Hb assessments between baseline and Month 12.|||percentage of participants|||Number
2567392|NCT02567188|Primary|Percentage of Participants With Hb Fluctuation From Pre-Baseline (Month -6) to Baseline|Hb fluctuation was defined as change in Hb value >15 gm/L between 2 visits.|Pre-baseline (Month -6) to Baseline|All enrolled participants. Here, number of participants analyzed= participants with at least 2 non-missing Hb assessments between pre-baseline (Month -6) and baseline.|||percentage of participants|||Number
2567393|NCT02567188|Primary|Mean Hb Value at Month 12 After Inclusion||Month 12|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||gm/L||Standard Deviation|Mean
2567394|NCT02567188|Primary|Mean Hb Value at Month 9 After Inclusion||Month 9|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||gm/L||Standard Deviation|Mean
2567395|NCT02567188|Primary|Mean Hb Value at Month 6 After Inclusion||Month 6|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||gm/L||Standard Deviation|Mean
2567396|NCT02567188|Primary|Mean Hb Value at Month 3 After Inclusion||Month 3|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||gm/L||Standard Deviation|Mean
2567397|NCT02567188|Primary|Mean Hb Value at Baseline||Baseline|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||gm/L||Standard Deviation|Mean
2567399|NCT02567188|Secondary|Percentage of Participants With Changes in Iron Supplement|Percentage of participants who had any change in their iron supplement medication at a specified visit were reported.|Pre-baseline (Months -6 and -3), baseline, Months 3, 6, 9 and 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure and n= participants evaluable for specified time points.|||percentage of participants|||Number
2567400|NCT02567188|Secondary|Correlation of Hb Levels With Levels of Inflammation||Baseline to 12 months|The units usage at and between study centres did change during the study and therefore no descriptive statistics could be performed on the laboratory variables.||||||
2567401|NCT02567188|Secondary|Correlation of Hb Levels With Underlying Disease||Baseline to 12 months|The units usage at and between study centres did change during the study and therefore no descriptive statistics could be performed on the laboratory variables.||||||
2567402|NCT02567188|Secondary|Percentage of Participants With Number of MIRCERA Dose Changes||Baseline to Month 12|All enrolled participants. Here, number of participants analyzed= participants with available data for this outcome measure.|||percentage of participants|||Number
2567403|NCT02567188|Secondary|Percentage of Participants With Change in MIRCERA Treatment|Change in MIRCERA treatment included changes in dose, frequency, and route of administration.|Months 3, 6, 9, and 12|All enrolled participants. Here, number of participants analyzed= participants evaluable for this outcome measure. n = number of participants evaluable at the specified time frame.|||percentage of participants|||Number
2567404|NCT02567188|Primary|Mean Hb Value at Month 6 Before Inclusion||Pre-baseline (Month -6)|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||gm/L||Standard Deviation|Mean
2567405|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 12 After Inclusion||Month 12|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||percentage of participants|||Number
2567406|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 9 After Inclusion||Month 9|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||percentage of participants|||Number
2567407|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 6 After Inclusion||Month 6|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||percentage of participants|||Number
2567408|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of > 100 and < 120 gm/L at Month 3 After Inclusion||Month 3|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||percentage of participants|||Number
2567409|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Baseline||Baseline|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||percentage of participants|||Number
2567410|NCT02567188|Primary|Percentage of Participants Reaching a Hb Value of >100 and < 120 gm/L at Month 3 Before Inclusion||Pre-baseline (Month -3)|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||percentage of participants|||Number
2567411|NCT02567188|Primary|Percentage of Participants Reaching a Hemoglobin (Hb) Value of Greater Than (>) 100 and Less Than (<) 120 Grams Per Liter (gm/L) at Month 6 Before Inclusion||Pre-baseline (Month -6)|All enrolled participants. Here, number of participants analyzed= participants with non-missing Hb assessment at specified time frame for this outcome measure.|||percentage of participants|||Number
2567412|NCT02566785|Secondary|Activity Balance Confidence Scale|Total range = 0-100% Higher values represent better outcome Total score is averaged = total%/16 responses|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2567413|NCT02566785|Primary|Dynamic Gait Index|8 increasingly challenging walking tasks (normal gait speed, changes in gait speed, walking with horizontal and vertical head movements, walking with pivot turn, walking over and around obstacles and stair climbing). A walkway path measured at 20 feet was used. A research assistance observed and scored all participants using a 0-3 scale, 0 = severe gait impairment, 1 = moderate gait impairment, 2 = mild/minimal impairment, 3 = normal gait, with a total possible scale range of 0 to 24 points. Scores ≤ 19 points was used to classify falling risk (Shumway-Cook et al. 1997).|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2567414|NCT02566785|Primary|Pre/Post Scores on the 30 Second Sit to Stand Test Will be Used to Detect Any Changes in Leg Strength and Endurance That Occur During the 12 Week Group Exercise Sessions.||Baseline and 12 weeks|Two of the participants in the WLC group were there for testing at 12 weeks.|||number of sit to stand cycles||Standard Deviation|Mean
2567415|NCT02566759|Secondary|Part 2 and 3: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-831||Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 24 hours) post-dose|The PK set included all participants with at least 1 estimable PK parameter for TAK-831. Due to discomfort observed in participants from the CSF collection procedure, Part 3 of the study was terminated hence no participants were analyzed.|||ng*hr/mL||Standard Deviation|Mean
2567416|NCT02566759|Secondary|Part 1, 2 and 4: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831||Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose|The PK set included all participants with at least 1 estimable PK parameter for TAK-831.|||ng*hr/mL||Standard Deviation|Mean
2567417|NCT02566759|Secondary|Part 1, 2 and 4: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831||Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose|The PK set included all participants with at least 1 estimable PK parameter for TAK-831.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
2567608|NCT02564887|Secondary|Swallowing Impairment|"visual analog scale related to patient perceived swallowing impairment at that point in time.~Minimum - 0 Maximum - 100 Higher is worse Score reported is the overall score at that time and not a change from baseline."|8 week||||score on a scale||Full Range|Mean
2567418|NCT02566759|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831||Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose; Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 24 hours) post-dose|The PK set included all participants with at least 1 estimable PK parameter for TAK-831. Due to discomfort observed in participants from the CSF collection procedure, Part 3 of the study was terminated hence no participants were analyzed.|||hours||Full Range|Median
2567419|NCT02566759|Secondary|Part 2 and 3: Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-831||Day 16 (Part 2) and Day 14 (Part 3) pre-dose and at multiple time points (up to 24 hours) post-dose|The PK set included all participants with at least 1 estimable PK parameter for TAK-831. Due to discomfort observed in participants from the CSF collection procedure, Part 3 of the study was terminated hence no participants were analyzed.|||ng/mL||Standard Deviation|Mean
2567420|NCT02566759|Secondary|Part 1, 2 and 4: Cmax: Maximum Observed Plasma Concentration for TAK-831||Day 1 pre-dose and at multiple time points (up to 96 hours in Part 1 and up to 72 hours in Part 2 and 4) post-dose|The PK set included all participants with at least 1 estimable PK parameter for TAK-831.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2567421|NCT02566759|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose|Markedly abnormal criteria for ECG was assessed. The lower cut-off point criteria and upper cut-off point criteria are as follow: heart rate <50 beats per minute (bpm) to >120 bpm; PR interval less than or equal to (<=) 80 millisecond (msec) to greater than or equal to (>=) 200 msec; QRS interval <=80 msec to >=180 msec; QT interval <=300 msec to >=460 msec; QTcB interval <=300 msec to >=500 msec or >=30 msec change from baseline and >=450 msec; QT interval with Fridericia's correction method (QTcF) interval <=50 msec to >=500 msec or >=30 msec change from baseline and >=450 msec.|Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4|The safety set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2567422|NCT02566759|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose|Markedly abnormal criteria for vital signs measurement was assessed. The lower criteria and upper criteria for abnormality are as follow: systolic blood pressure at less than (<) 85 millimeter of mercury (mm Hg) to greater than (>) 180 mm Hg; diastolic blood pressure < 50 mm Hg to >110 mm Hg; pulse rate <50 bpm to >120 bpm; Temperature <35.6 degree Celsius to >37.7 degree Celsius.|Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4|The safety set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2567423|NCT02566759|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose|Clinical laboratory tests included hematology, serum chemistry and urinalysis.|Baseline up to Day 15 in Part 1, Day 30 in Part 2, Day 28 in Part 3 and Day 25 in Part 4|The safety set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2567424|NCT02566759|Primary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)||Baseline up to 30 days after the last dose of study drug (Part 1 Day 31, Part 2 Day 46, Part 3 Day 44 and Part 4 Day 43)|The safety set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2567425|NCT02566590|Primary|The Percent Change in Bilateral Thigh Lean Mass Density (Grams) as Measured by DEXA Scan Will be Compared Between Baseline and After 5-days of Bed Rest|Thigh lean mass (grams) will be measured by DEXA scan at baseline and after 5-days of bed rest. The change in thigh lean mass will be calculated between these two time points. This outcome will be measured for the Control and the NMES + PRO groups.|Baseline and after 5-days of Bed rest||||Percent Change||Standard Error|Mean
2567426|NCT02566577|Secondary|Change in Levels of IL-2|Plasma IL-2 concentration will be measured by enzyme-linked immunosorbent assay (ELISA). Change is the difference in the levels of IL-2 from baseline to Day 1 (first post-transfusion day). Higher concentrations of IL-2 indicate increased vascular inflammation.|Baseline (prior to transfusion), Day 1 (first post-transfusion day)|Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.||||||
2567427|NCT02566577|Secondary|Change in Levels of IL-6|Plasma IL-6 concentration will be measured by enzyme-linked immunosorbent assay (ELISA). Change is the difference in the levels of IL-6 from baseline to Day 1 (first post-transfusion day). Higher concentrations of IL-6 indicate increased vascular inflammation.|Baseline (prior to transfusion), Day 1 (first post-transfusion day)|Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.||||||
2567428|NCT02566577|Secondary|Change in High-sensitivity C-reactive Protein (hsCRP)hsCRP|Levels of high-sensitivity C-reactive protein (hsCRP) in the blood will be measured by using Dade Behring nephelometry. Higher levels of hsCRP indicate increased vascular inflammation.|Baseline (prior to transfusion), Day 1 (first post-transfusion day)|Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.||||||
2567429|NCT02566577|Secondary|Change in Levels of Nitric Oxide Metabolites|Nitric oxide metabolites like nitrite, nitrate, S-nitrosothiols (SNO-Hb and SNO-thiol) will be measured from blood samples using high-performance liquid chromatography (HPLC). Higher levels of nitric oxide metabolites indicate higher levels of nitric oxide (NO) synthesis and better vascular reactivity.|Baseline (prior to transfusion), Day 1 (first post-transfusion day)|Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.||||||
2567430|NCT02566577|Secondary|Change in Oxidative Stress Markers|Oxidative stress will be measured using high-performance liquid chromatography (HPLC) to collect plasma cystine, cysteine, glutathione, and glutathione disulfide levels. Higher levels of cystine, cysteine, glutathione, and glutathione disulfide indicate higher levels of vascular inflammation.|Baseline (prior to transfusion), Day 1 (first post-transfusion day)|Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.||||||
2567512|NCT02565628|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06669571 on Day 1 and Day 7|Tmax of PF-06669571 was observed directly from data on Day 1 and Day 7, as time of first occurrence.|0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7|The PF-06669571 PK concentration analysis set was used for this analysis, and it was defined as all subjects randomized and treated who have at least 1 measureable concentration of interest.|||hr||Full Range|Mean
2567431|NCT02566577|Secondary|Peak VO2 Lean|Subjects will undergo graded treadmill testing following American Heart Association guidelines using the modified Balke protocol. A treadmill with full metabolic cart will be used for the cardiopulmonary testing. Peak VO2 lean is the peak oxygen uptake adjusted for lean body mass and is reported as a lean body weight-adjustment parameter in mL/kg per minute.|Day 1 (first post-transfusion day)|Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.||||||
2567432|NCT02566577|Secondary|O2 Pulse|Subjects will undergo graded treadmill testing following American Heart Association guidelines using the modified Balke protocol. A treadmill with full metabolic cart will be used for the cardiopulmonary testing. O2 (oxygen) pulse is the amount of O2 consumed from the volume of blood delivered to tissues by each heartbeat; this index is calculated as: O2 pulse = VO2 / heart rate. A higher O2 pulse indicates better vascular reactivity.|Day 1 (first post-transfusion day)|Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.||||||
2567433|NCT02566577|Secondary|Respiratory Exchange Ratio (RER):|Subjects will undergo graded treadmill testing following American Heart Association guidelines using the modified Balke protocol. A treadmill with full metabolic cart will be used for the cardiopulmonary testing. RER is the ratio of VCO2 (carbon dioxide output) to VO2 (oxygen uptake). A higher RER indicates better vascular reactivity.|Day 1 (first post-transfusion day)|Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.||||||
2567434|NCT02566577|Secondary|Maximal Oxygen Uptake (VO2Max)|Subjects will undergo graded treadmill testing following American Heart Association guidelines using the modified Balke protocol. A treadmill with full metabolic cart will be used for the cardiopulmonary testing. Maximal oxygen uptake (VO2Max) is the value achieved when the oxygen uptake remains stable despite a progressive increase in the intensity of exercise. The VO2Max will be calculated from the cardiac output and the arteriovenous oxygen difference during peak exercise. VO2Max is expressed in milliliters of oxygen per minute per kilogram of body weight (ml/min/kg). A higher VO2Max indicates better vascular reactivity.|Day 1 (first post-transfusion day)|Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.||||||
2567435|NCT02566577|Primary|Change in Reactive Hyperemic Index (RHI)|Reactive Hyperemia Index (RHI) will be measured using Pulsatile Arterial Tonometry (PAT). Baseline blood pressure of both hands is measured and PAT probes are placed one on each hand at the same finger (fingers 2, 3 or 4). Following an equilibration period of 10 minutes, the blood pressure cuff will be inflated to 60 mmHg above systolic pressure for 5 minutes followed by deflation of the cuff and the pulsatile recordings from both study and control fingers will be measured. RHI will be calculated from the ratio of the digital pulse volume during reactive hyperemia (following cuff deflation) and baseline. A higher RHI indicates better nitric oxide-dependent endothelial function.|Baseline (prior to transfusion), Day 1 (first post-transfusion day)|Data were not collected. The study subjects could not complete the proposed study procedure due to preexisting comorbidities.||||||
2567436|NCT02566577|Primary|Change in Flow-mediated Vasodilation (FMD)|Brachial artery flow-mediated dilation (FMD) will be performed by using ultrasonography. The brachial artery of the non-dominant arm will be imaged using a high-resolution 13 MHz ultrasound transducer. A blood pressure cuff on the forearm will be inflated to supra-systolic pressures to produce 5 minutes of ischemia. After cuff deflation, imaging of the brachial artery will be performed continuously for the next 120 seconds and the flow-mediated dilation will be calculated. Change in FMD is the percent change in the diameter of the brachial artery from baseline (prior to transfusion) to Day 1 (first post-transfusion day). A higher FMD indicates better nitric oxide-dependent endothelial function.|Baseline (prior to transfusion), Day 1 (first post-transfusion day)|The data are not stratified by data points/study periods, as the data points were not collected due to non-compliant nature of the enrolled subjects. Majority of the subjects did not complete the study entirety.|||percentage of FMD||Standard Deviation|Mean
2567437|NCT02566369|Primary|Investigator Global Assessment (IGA) Success Rate at Week 12|Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.|From Baseline to Week 12||||Participants|||Count of Participants
2567438|NCT02566317|Other Pre-specified|Dynamic Glucose Control|Continuous glucose monitoring in prediabetics|3 months|||||||
2567439|NCT02566317|Other Pre-specified|Ecological Momentary Assessment of Mood|Periodic monitoring of mood, energy, fatigue in smartphone users|1 year|||||||
2567440|NCT02566317|Other Pre-specified|Ambulatory Blood Pressure|Dynamic changes in ambulatory blood pressure in prehypertensives|3 months|||||||
2567441|NCT02566317|Other Pre-specified|Sleep Substudy|24h wrist accelerometry in individuals with minor-moderate sleep complaints|1 year|||||||
2567442|NCT02566317|Secondary|Clustered Metabolic Risk Score From Baseline to 12 Months|Clustered metabolic risk score (fasting glucose, insulin, triglycerides, HDL-cholesterol, blood pressure); value at 12 months minus value at baseline; higher scores indicate better outcome. The Z-score for each component (fasting glucose, insulin, triglycerides, HDL-cholesterol, blood pressure) based on the baseline mean and standard deviation of the entire group was computed and summed for each participant (HDL z-score was subtracted rather than added). The sum of these z-scores represents the metabolic risk score.|1 year|In MOVE+ (n=247), 10 did not attend posttest visit, 3 were unable to perform a blood draw, 19 refused blood draw, 3 had an insufficent sample, and 8 were missing covariates. In STAND+ (n=292), 16 did not attend posttest visit, 3 were unable to perform a blood draw, 27 refused blood draw, 3 had an insufficent sample, and 5 were missing covariates.|||units on a scale||95% Confidence Interval|Mean
2567443|NCT02566317|Primary|Mean Change in Sitting Time at Work From Baseline to 12 Months|Measured via 7d of activPAL accelerometry (value at 12 months minus value at baseline)|1 year|Among those who completed the study in the MOVE+ arm (n=247), 16 did not have sufficient valid workdays and 7 were missing covariates. Among those who completed the study in the STAND+ arm (n=292), 17 did not have sufficient valid workdays and 12 were missing covariates.|||Mean Change, minutes per 8h workday||95% Confidence Interval|Mean
2567561|NCT02565485|Secondary|Interventions to Correct Maternal Hypotension or Fetal Heart Rate Abnormalities (Position Change, Supplemental Oxygen, Vasopressor Support, Emergent Operative Delivery)||First 60 minutes following epidural placement||||Participants|||Count of Participants
2567444|NCT02566317|Primary|Mean Change in Light-intensity Physical Activity at Work From Baseline to 12 Months|Measured via 7d of activPAL accelerometry (value at 12 months minus value at baseline)|1 year|Among those who completed the study in the MOVE+ arm (n=247), 16 did not have sufficient valid workdays and 7 were missing covariates. Among those who completed the study in the STAND+ arm (n=292), 17 did not have sufficient valid workdays and 12 were missing covariates.|||Mean change, minutes per 8hr workday||95% Confidence Interval|Mean
2567445|NCT02566265|Primary|Number of Participants With Treatment Failure by Primary Endpoint|Any documented flu infection during the 2015-2016 flu season or evidence of disease progression.|1 year||||Participants|||Count of Participants
2567446|NCT02566135|Primary|Total Intubation Time||5 minutes||||Second||Standard Deviation|Mean
2567447|NCT02566135|Primary|Time of Insertion||5 minutes||||Seconds||Standard Deviation|Mean
2567448|NCT02566135|Secondary|Diastolic Blood Pressure|"Diastolic blood pressure measured at following time intervals.~Base line~After Dexmedetomidine injection~After Induction~Supraglottic airway insertion~Ventilating bougie insertion~ETT insertion~3 minute after ETT insertion~5 minute after ETT insertion~7 minute after ETT insertion~10 minutes after ETT insertion~15 minute after ETT insertion The study period was upto 15 minutes. thereafter study ends."|25 minutes||||mmhg||Standard Deviation|Mean
2567449|NCT02566135|Secondary|Systolic Blood Pressure|"Systolic blood pressure measured at following time intervals.~Base line~After Dexmedetomidine injection~After induction of anaesthesia~Supraglottic airway insertion~Ventilating bougie insertion~ETT insertion~3 minute after ETT insertion~5 minute after ETT insertion~7 minute after ETT insertion~10 minute after ETT insertion~15 minute after ETT insertion. The study period was upto 15 minutes and thereafter the study ends."|25 minutes||||mmhg||Standard Deviation|Mean
2567450|NCT02566135|Secondary|Heart Rate|"Heart rate to observe at the following time intervals.~Base line~After induction~After dexmedetomidine injection~Supraglottic airway insertion~Ventilating bougie insertion~ETT insertion~3minute after ETT insertion~5 minute after ETT insertion~7 minute after ETT insertion~10 minute after ETT insertion~15 minute after ETT insertion Study period is upto 15 minutes, thereafter the study ends here."|25 minutes||||beats per minute||Standard Deviation|Mean
2567451|NCT02566135|Primary|Number of Attempts for Railroading of Endotracheal Tube Over Ventilating Bougie||30 seconds||||attempt|||Number
2567452|NCT02566135|Primary|Number of Attempts for Ventilating Bougie Insertions Through I-gel or C-LMA||45 seconds||||attempt|||Number
2567453|NCT02566135|Primary|Number of Attempts for I-gel or Classic-LMA Insertions||60 seconds||||attempt|||Number
2567454|NCT02566109|Other Pre-specified|Exploratory Algorithmic Modeling|To use exploratory algorithmic modeling to obtain optimal strategies for determining the combination of metrics (10-min MR, ECHO, serum biomarkers) at 2-months that predict the 6-month post Chemotherapy deteriorations in cardiovascular function.|Baseline to 6 months|||||||
2567455|NCT02566109|Secondary|End Systolic Volume (ESV): Compare Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline|To compare magnetic resonance imaging (MRI) metric of End Systolic Volume (ESV) with echocardiogram (ECHO) at baseline|Baseline|All 6 participants that received both an ECHO. Only 5 had an MRI at baseline|||mL||Standard Deviation|Mean
2567456|NCT02566109|Secondary|End Diastolic Volume (EDV): Compare Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline|To compare magnetic resonance imaging (MRI) metric of End Diastolic Volume (EDV) with echocardiogram (ECHO) at baseline|Baseline|All 6 participants that received both an ECHO. Only 5 had an MRI at baseline|||mL||Standard Deviation|Mean
2567457|NCT02566109|Secondary|Left Ventricular Ejection Fraction (LVEF): Comparison of Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline|To compare Magnetic Resonance Imaging (MRI) metric of Left Ventricular Ejection Fraction (LVEF) with Echocardiogram (ECHO) at baseline|Baseline|All 6 participants that received both an ECHO. Only 5 had an MRI at baseline|||percentage of fluid expelled||Standard Deviation|Mean
2567458|NCT02566109|Primary|Pulse Wave Velocity (PWV) at Baseline and 6 Months|To compare baseline and 6 month measures in pulse wave velocity (PWV)|Baseline and 6 months|Only 5 received MRI at baseline and 3 at 6 months.|||Meters/sec||Standard Deviation|Mean
2567459|NCT02566109|Primary|End Systolic Volume (ESV) at Baseline, 2 Month, and 6 Months|To compare baseline, 2-month (using Fast MRI), and 6 month measures in end Systolic Volume (ESV)|Baseline, 2 months, and 6 months|Only 5 received MRI at baseline, 4 at 2 months using Fast MRI, and 3 at 6 months.|||mL||Standard Deviation|Mean
2567460|NCT02566109|Primary|End Diastolic Volume (EDV) at Baseline, 2 Month, and 6 Months|To compare baseline, 2-month (using Fast MRI), and 6 month measures in end Diastolic Volume (EDV)|Baseline, 2 months, and 6 months|Only 5 received MRI at baseline, 4 at 2 months using Fast MRI, and 3 at 6 months.|||mL||Standard Deviation|Mean
2567461|NCT02566109|Primary|Left Ventricular Ejection Fraction (LVEF) at Baseline, 2 Month Using Fast MRI, and 6 Months|To compare baseline, 2-month (using Fast MRI), and 6 month measures in left ventricular (LV) ejection fraction|Baseline, 2 months, and 6 months|Only 5 received MRI at baseline, 4 at 2 months using Fast MRI, and 3 at 6 months.|||percentage of fluid ejected||Standard Deviation|Mean
2567462|NCT02566083|Primary|Rate of Severe Visual Distortions|The rate of severe visual distortions under overall circumstances for the five visual distortion items of interest (lines that slant, tilt, split or separate; flat surfaces appearing curved; objects appearing further away or closer than they are; objects appearing to have a different size or shape; and physical discomfort related to vision). The six month data were used for this endpoint if available and if not an earlier visit was used. If a subject had a lens repositioning the questionnaire prior to the repositioning was used if available.|6 months|All subjects bilaterally implanted with a toric IOL (ZCT300 or ZCT400) and all subjects bilaterally implanted with a control IOL (ZCB00). All subjects who were monocularly implanted with a toric IOL (ZCT300/400) or control were excluded from the analysis.|||Participants|||Count of Participants
2567463|NCT02566044|Secondary|Cohorts 1, 2: Change From Baseline in Lung Clearance Index (LCI) From Baseline to Day 7 for Cohort 1, Day 14 for Cohort 2.|Change in Lung Clearance Index (LCI) will be conducted by multiple breath nitrogen washout according to international standards|Baseline to EOS|Pharmacodynamics analysis set: The PD analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.|||Ratio||Standard Deviation|Mean
2567562|NCT02565485|Secondary|New Onset Hypotension (>20% Decrease in Systolic and/or Diastolic Blood Pressure)||First 60 minutes following epidural placement||||Participants|||Count of Participants
2567464|NCT02566044|Secondary|Cohorts 1 and 2: Change From Baseline in Percent Predicted Forced Expiratory Volume in the First Second by Spirometry (% Predicted FEV1)|To evaluate the response to multiple doses of inhaled QBW276 in percent predicted forced expiratory volume in the first second by spirometry according to international standards over 1 or 2 weeks of treatment compared with placebo in patients with cystic fibrosis.|Baseline to End of study (EOS)|Pharmacodynamics analysis set: The PD analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.|||Percent predicted FEV1||Standard Deviation|Mean
2567465|NCT02566044|Primary|Cohorts 1 and 2: Pharmacokinetics Accumulation Ratio (Racc) of QBW276, QBP545, and QBV697 in Plasma|The accumulation ratio (Racc) will be reported using blood samples taken on days 1 -7 in cohort 1 and days 1-14 in cohort 2. Accumulation ratio (Racc) for QBW276 and metabolites was not calculated by PK software for patients where BLOQ values were observed for all blood samples in their PK profile.|Cohort 1: 7 days; Cohort 2: 14 days|Pharmacokinetic set: The PK analysis set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data.|||Ratio||Standard Error|Mean
2567466|NCT02566044|Primary|Cohorts 1 and 2: Pharmacokinetics (AUCtau) of QBW276, QBP545, and QBV697 in Plasma|Blood collection will be used to observe the maximum plasma concentration (AUCtau) following administration of QBW276. Pharmacokinetic blood samples were collected at the time points. In Cohorts 1 and 2 this consisted of multiple samples through 6 hours after inhalation on Days 1 and 7 in Cohort 1 and Days 1 and 14 in Cohort 2 with predose samples on selected days. The AUCtau, was determined using the actual recorded sampling times and noncompartmental methods. Since steady state was likely reached by Day 7, AUCtau on Days 7 or 14 correspond to AUClast,ss|Day 1, 7 and 14|Pharmacokinetic set: The PK analysis set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data.|||hr*ng/mL||Standard Deviation|Mean
2567467|NCT02566044|Primary|Cohorts 1 and 2: Pharmacokinetics (Tmax) of QBW276, QBP545, and QBV697 in Plasma|Blood collection will be used to observe the maximum plasma concentration (Tmax) following administration of QBW276. Pharmacokinetic blood samples were collected at the time points. In Cohorts 1 and 2 this consisted of multiple samples through 6 hours after inhalation on Days 1 and 7 in Cohort 1 and Days 1 and 14 in Cohort 2 with predose samples on selected days. The Tmax, was determined using the actual recorded sampling times and noncompartmental methods. Since steady state was likely reached by Day 7, Tmax on Days 7 or 14 correspond to Tmax,ss|Day 1, 7 and 14|Pharmacokinetic set: The PK analysis set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data.|||hr||Full Range|Median
2567468|NCT02566044|Primary|Cohorts 1 and 2: Pharmacokinetics (Cmax) of QBW276, QBP545, and QBV697 in Plasma|Blood collection will be used to observe the maximum plasma concentration (Cmax) following administration of QBW276. Pharmacokinetic blood samples were collected at the time points. In Cohorts 1 and 2 this consisted of multiple samples through 6 hours after inhalation on Days 1 and 7 in Cohort 1 and Days 1 and 14 in Cohort 2 with predose samples on selected days. The Cmax, was determined using the actual recorded sampling times and noncompartmental methods. Since steady state was likely reached by Day 7, Cmax on Days 7 or 14 correspond to Cmax,ss|Cohort 1: day 1, 7; Cohort 2: day 1, 14|Pharmacokinetic set: The PK analysis set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data.|||ng/mL||Standard Deviation|Mean
2567469|NCT02566044|Primary|Cohorts 1 and 2: Safety Assessments, Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).|Adverse events were summarized by the number of patients having any adverse event overall and presented in the safety section. Study was prematurely terminated|Cohort 1: day 1-7; Cohort 2: day 1-14|Safety set: The safety analysis set included all patients that received any study drug|||Participants|||Number
2567470|NCT02566031|Secondary|Daily Rescue Medication Use (Number of Puffs)|The total number of puffs of rescue medication used over the last 24 hours will be recorded in the patient diary in the morning. The total number of puffs of rescue medication per day over the full 12 weeks will be calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the patient. The mean daily number of puffs of rescue medication used over 12 weeks will be summarized by treatments|Week 12|"The full analysis set (FAS) consisted of all randomized patients who received at least one dose of study treatment and have at least one evaluable post-baseline assessment.~Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization"|||Puffs/day||Standard Deviation|Mean
2567471|NCT02566031|Secondary|Number of Participants With Change From Baseline on Total Score of COPD Assessment Test (CAT)|Total score of COPD Assessment Test (CAT) will be measured at week 12. This questionnaire is completed by the patient. The score ranges from 0-40 where higher scores represent worse health status. Mild: Score = 0 - 10, Moderate: Score = 11 - 20, Severe: Score = 21 - 30, Very Severe: Score = 31 - 40. The CAT total score was the sum of 8 item scores (each ranging from 0 to 5). If 1 or 2 items were missing, they were replaced with the mean of the completed items. If 3 or more items were missing, the CAT total score was set missing|Week 12|"The full analysis set (FAS) consisted of all randomized patients who received at least one dose of study treatment and have at least one evaluable post-baseline assessment.~Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization"|||Number of participants|||Number
2567472|NCT02566031|Secondary|Baseline Transitional Dyspnea Index (TDI) Focal Score|A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing). TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. TDI captures changes from baseline, each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score.|Week 12|"The full analysis set (FAS) consisted of all randomized patients who received at least one dose of study treatment and have at least one evaluable post-baseline assessment.~Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization"|||Score||Standard Deviation|Mean
2567473|NCT02566031|Secondary|Trough Forced Expiratory Volume In One Second (FEV1) After 4 Weeks of Treatment|Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the mean of 45 minute and 15 minute pre-dose values.|mean of 45 min and 15 min pre-dose week 4|"The full analysis set (FAS) consisted of all randomized patients who received at least one dose of study treatment and have at least one evaluable post-baseline assessment.~Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization"|||Liters||Standard Deviation|Mean
2567474|NCT02566031|Primary|Trough Forced Expiratory Volume In One Second (FEV1) After 12 Weeks of Treatment|Spirometry was performed according to internationally accepted standards. Trough FEV1 is defined as the mean of 45 minute and 15 minute pre-dose values.|Week 12|"The full analysis set (FAS) consisted of all randomized patients who received at least one dose of study treatment and have at least one evaluable post-baseline assessment.~Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization"|||Liters||Standard Deviation|Mean
2567475|NCT02566005|Secondary|Estimated Blood Loss||Day 1||||ml||Standard Deviation|Mean
2567476|NCT02566005|Secondary|Incidence of Patient Discomfort||Day 1|data not collected||||||
2567477|NCT02566005|Secondary|Incidence of Uterine Tachysystole||Day 1||||Participants|||Count of Participants
2567478|NCT02566005|Secondary|Incidence of Chorioamnionitis||Day 1||||Participants|||Count of Participants
2567479|NCT02566005|Secondary|The Time From Active Phase to Delivery||Day 1||||hours||Standard Deviation|Mean
2567480|NCT02566005|Secondary|The Time From Induction Until to Active Phase Labor||Day 1||||hours||Standard Deviation|Mean
2567481|NCT02566005|Primary|Per Treatment Protocol: Time (Hours) From Induction to Delivery||day 1|those participants on treatment protocol|||hours||Standard Deviation|Mean
2567482|NCT02566005|Primary|Time From Induction to Delivery: CD|Time (hours) from induction to delivery: Cesarean Delivery (CD)|Day 1||||hours||Standard Deviation|Mean
2567483|NCT02566005|Primary|Time From Induction to Delivery: VD|Time (hours) from induction to delivery: Vaginal Delivery (VD)|Day 1||||hours||Standard Deviation|Mean
2567484|NCT02566005|Primary|Time (Hours) From Induction to Delivery: Multiparous||Day 1|for nulliparous participants|||hours||Standard Deviation|Mean
2567485|NCT02566005|Primary|Time (Hours) From Induction to Delivery: Nulliparous||Day 1|for nulliparous participants|||hours||Standard Deviation|Mean
2567486|NCT02566005|Primary|The Time Interval From Induction to Delivery: All Participants|During labor from the start of the induction to the delivery|Day 1||||hours||Standard Deviation|Mean
2567487|NCT02565810|Secondary|Subject Preference of SC Delivery Administration of SB5 Using Questionnaire||at Week 6|Overall number of participants analyzed means number of subjects with available assessment results|||number of responders|||Number
2567488|NCT02565810|Secondary|Overall Impression of SC Delivery Administration of SB5 Using Questionnaire|Objective: To evaluate whether overall impressions of SC administrations at Week 2 and Week 6 were comparable between the SC administrations of SB5 via the Pen and via the PFS.|at Week 2 and at Week 6|Only number of subjects with available assessment results at each visit were counted as 'Overall number of participants analyzed'.|||Participants|||Count of Participants
2567489|NCT02565810|Primary|The Change in Injection Site Pain Score Using an 11-point Visual Numeric Scale|Injection site pain evaluation questionnaire will be rated on an 11-point numeric rating scale ranging from 0 (no pain) to 10 (pain as bad as it could be) at two-time points post-injection (immediately post-injection and between 15 to 30 minutes post-injection) at Weeks 0, 2, 4, and 6.|Difference of injection site pain score (Week 6 - Week 2)||||Difference (scores on a scale)||97.5% Confidence Interval|Number
2567490|NCT02565784|Secondary|Percentage of Participants Improved in Upper Cheek Fullness - Judged by Investigator|"The Merz aesthetic scale for upper cheek fullness is a validated photograph-based outcome instrument designed specifically for assessing cheek fullness. The scale is graded 0-4 where 0 is Full upper cheek and 4 is Very severely sunken upper cheek.~A participant is assessed as improved if she scores at least one grade improvement from baseline."|6 and 12 Months after first and second treatment, respectively|All 100 participants were injected in the upper cheeks, but 1 participant was not injected in left upper cheek at baseline.|||percentage of participants||95% Confidence Interval|Number
2567491|NCT02565784|Secondary|Percentage of Participants Improved in Nasolabial Fold Severity (Merz Aesthetic Scale) - Judged by Investigator|"The Merz aesthetic scale for nasolabial folds (NLFs) is a validated photograph-based outcome instrument designed specifically for assessment of NLFs. The scale is graded 0-4 where 0 is No folds and 4 is Very severe folds.~A participant is considered improved if she scores at least one grade improvement from baseline."|6 and 12 Months after first and second treatment, respectively|In total, 88 participants were injected in the right NLF and 86 participants were injected in the left NLF|||percentage of participants||95% Confidence Interval|Number
2567492|NCT02565784|Primary|"Percentage of Participants Improved in Global Facial Aesthetic Appearance - Judged by Participant"|"Number of improved participants according to Global Aesthetic Improvement Scale (GAIS) 6 months after initial treatment.~The GAIS is a qualitative 5-graded scale evaluating aesthetic improvement: Very much improved, Much improved, Improved, No change, Worse.~A participant is considered improved if she answers Very much improved, Much improved, or Improved."|6 Months||||percentage of participants||95% Confidence Interval|Number
2567493|NCT02565706|Secondary|Response to Survey Items Assessing Knowledge of Area Farmers' Markets|Farmers' Market-specific Knowledge Score range:0-2 Higher scores indicate greater knowledge|Pretest, posttest, and 3- and 6-month follow-up||||Units on a scale||Standard Error|Least Squares Mean
2567494|NCT02565706|Secondary|Response to Survey Items Assessing Food-specific Knowledge Using a True/False Format|Food-specific Knowledge Score range: 2-13 Higher scores indicate greater knowledge|Pretest, posttest, and 3- and 6-month follow-up||||Units on a scale||Standard Error|Least Squares Mean
2567495|NCT02565706|Secondary|Response to Survey Items Assessing Knowledge of Locally Grown Seasonal Fruits and Vegetables Found at Farmers' Markets in July Using a Yes/no Format.|Knowledge of Locally Grown Seasonal Fruits and Vegetables found at Farmers' Markets in July Score range:0-9 Higher scores indicate greater knowledge|Pretest, posttest, and 3- and 6-month follow-up||||Units on a scale||Standard Error|Least Squares Mean
2567496|NCT02565706|Secondary|Response to an Item Assessing Behavioral Intentions to Purchase Fruits and Vegetables at a Farmers' Market in the Next Two Weeks Using a Yes/no Format.|Intentions to Purchase Fruits and Vegetables at a Farmers' Market Scores: no (0), Yes (1). Higher scores (yes responses) indicate that the respondent intends to purchase fruits and vegetables at a farmers' market in the next two weeks. Odds ratios and 95% confidence intervals indicate the likelihood of the outcome (intending to purchase fruits and vegetables at a farmers' market in the next two weeks) among those in the WIC Fresh Start (FMNP) arm relative to the comparator arm.|Pretest, posttest, and 3- and 6-month follow-up|The WIC Fresh Start Program (FMNP) arm is being compared with the three other study arms.|||Odds ratio||95% Confidence Interval|Number
2567497|NCT02565706|Secondary|Response to an Item Assessing Whether the Participant Purchased Fruits and Vegetables at a Farmers' Market in the Past Two Weeks Using a Yes/no Format.|Recent Farmers' Market Fruit and Vegetable Purchases Scores: No (0), Yes (1). Higher scores (yes responses) indicate that the respondent purchased fruits and vegetables at a farmers' market in the past two weeks. Odds ratios and 95% confidence intervals indicate the likelihood of the outcome (having purchased fruits and vegetables at a farmers' market in the past two weeks) among those in the WIC Fresh Start (FMNP) arm relative to the comparator arm.|Pretest, posttest, and 3- and 6-month follow-up|The WIC Fresh Start (FMNP) arm is being compared with the three other study arms.|||Odds ratio||95% Confidence Interval|Number
2567498|NCT02565706|Secondary|Response to Survey Items Assessing Farmers' Market Fruit and Vegetable Preparation Skills Using 7-point Likert Rating Scales.|Farmers' Market Fruit and Vegetable Preparation Skills Score range:12-84 Higher scores indicate greater skills|2 weeks||||Units on a scale||Standard Error|Least Squares Mean
2567499|NCT02565706|Secondary|Response to an Item Assessing Whether the Participant Ever Purchased Fruits and Vegetables at a Farmers' Market Using a Yes/no Format.|Lifetime Farmers' Market Fruit and Vegetable Purchases Scores: No (0), Yes (1). Higher scores (yes responses) indicate indicate that the respondent has ever purchased fruits and vegetables at a farmers' market. Odds ratios and 95% confidence intervals indicate the likelihood of the outcome (having ever purchased fruits and vegetables at a farmers' market) among those in the WIC Fresh Start (FMNP) arm relative to the comparator arm.|Pretest, posttest, and 3- and 6-month follow-up|The WIC Fresh Start (FMNP) arm is being compared with the three other study arms.|||Odds ratio||95% Confidence Interval|Number
2567500|NCT02565706|Secondary|Response to Survey Items Assessing Positive Outcome Expectations for Consuming Locally Grown Fruits and Vegetables Using a Yes/no Format.|Positive Outcome Expectations for Consuming Locally Grown Fruit and Vegetables Score range:0-3 Higher scores indicate more favorable ratings|Pretest, posttest, and 3- and 6-month follow-up||||Units on a scale||Standard Error|Least Squares Mean
2567501|NCT02565706|Secondary|Response to Survey Items Assessing Farmers' Market Asking Skills Using a Yes/no Format.|Farmers' Market Asking Skills Score range: 0-3 Higher scores indicate greater skills|Pretest, posttest, and 3- and 6-month follow-up||||Units on a scale||Standard Error|Least Squares Mean
2567502|NCT02565706|Secondary|Response to Survey Items Assessing Fruit and Vegetable Food Safety Skills Using 7-point Likert Rating Scales.|Fruit and Vegetable Food Safety Skills Score range: 19-85 Higher scores indicate greater skills|Pretest, posttest, and 3- and 6-month follow-up||||Units on a scale||Standard Error|Least Squares Mean
2567503|NCT02565706|Secondary|Response to Survey Items Assessing Awareness of Locally Grown, Seasonal Fruits and Vegetables Using a Yes/no Format.|Familiarity with Locally Grown Seasonal Items Score range: 0-3 Higher scores indicate greater familiarity|Pretest, posttest, and 3- and 6-month follow-up||||Units on a scale||Standard Error|Least Squares Mean
2567504|NCT02565706|Secondary|Response to Survey Items Assessing Attitudes Towards Farmers' Market Fruits and Vegetables Using 7-point Likert Rating Scales.|Attitudes towards Farmers' Market Fruits and Vegetables Score range: 6-42 Higher scores indicate more favorable attitudes|Pretest, posttest, and 3- and 6-month follow-up||||Units on a scale||Standard Error|Least Squares Mean
2567505|NCT02565706|Secondary|Response to an Item Assessing Knowledge of WIC-authorized Farmers' Markets Using a Yes/no Format.|Knowledge of a farmers' market with farmers approved by WIC to accept WIC farmers' Market Nutrition Program and Cash Value vouchers Scores: No (0) and yes (1). Higher scores (yes responses) indicate that the respondent knows of a farmers' market with farmers approved by WIC to accept WIC farmers' Market Nutrition Program and Cash Value vouchers. Odds ratios and 95% confidence intervals indicate the likelihood of the outcome (knowledge of such markets) among those in the WIC Fresh Start (FMNP) arm relative to the comparator arm.|Pretest, posttest, and 3- and 6-month follow-up|The WIC Fresh Start Program (FMNP) arm is being compared with each other study arm for this analysis.|||Odds ratio||95% Confidence Interval|Number
2567506|NCT02565706|Secondary|Response to Survey Items Assessing Knowledge of the WIC Farmers' Market Nutrition Program Using a True/False Format.|Index of Knowledge of the FMNP Score range: 0-6 Higher scores indicates greater knowledge|Pretest, posttest, and 3- and 6-month follow-up||||Units on a scale||Standard Error|Mean
2567507|NCT02565706|Secondary|Number of Participants Who Redeemed Cash Value Vouchers at Farmers' Markets|The state WIC agency is providing data on cash value voucher redemption.|6 months (2015 farmers' market season [June to November 2015])||||Participants|||Count of Participants
2567508|NCT02565706|Primary|Quantity of Fruit and Vegetable Intake|Cups per day consumed of fruits and vegetables as assessed by a validated fruit and vegetable screener.|Pretest, posttest, and 3- and 6-month follow-up|Data are reported for the 6-month follow-up assessment.|||Cups per day consumed||Standard Error|Least Squares Mean
2567509|NCT02565706|Primary|Frequency of Fruit and Vegetable Intake|Times per day fruits and vegetable are consumed as assessed by a validated food frequency questionnaire.|Pretest, posttest (2 weeks after pretest), and 3- and 6-month follow-up||||Times per day consumed||Standard Error|Least Squares Mean
2567510|NCT02565706|Primary|Number of Participants Who Redeemed FMNP Vouchers|The state WIC agency is providing data on FMNP voucher redemption.|6 months (2015 farmers' market season [June to November 2015])||||participants|||Number
2567511|NCT02565628|Secondary|Area Under Curve From Time Zero to 24 Hours (AUC24) of PF-06669571 on Day 7|AUC24 of PF-06669571 refers to the area under the curve from time zero to 24 hours post dose on Day 7. AUC24 was determined by using linear/log trapezoidal method|0, 1, 3, 5, 8, 12 and 24 hours post-dose on Day 7|The PF-06669571 PK parameter analysis set was used for this analysis, and it was defined as all subjects randomized and treated who have at least 1 of the PK parameters of interest measured.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2567513|NCT02565628|Secondary|Area Under Curve From Time Zero to 12 Hours (AUC12) of PF-06669571 on Day 1 and Day 7|AUC12 of PF-06669571 refers to the area under the curve from time zero to 12 hours post dose on Day 1 and Day 7. AUC12 was determined by using linear/log trapezoidal method.|0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7|The PF-06669571 PK parameter analysis set was used for this analysis, and it was defined as all subjects randomized and treated who have at least 1 of the PK parameters of interest measured.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2567514|NCT02565628|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-06669571 on Day 1 and Day 7|Cmax of PF-06669671 was observed directly from data on Day 1 and Day 7|0, 1, 3, 5, 8 and 12 hours post-dose on both Day 1 and Day 7|The PF-06669571 pharmacokinetics(PK) concentration analysis set was used for this analysis, and it was defined as all subjects randomized and treated who have at least 1 measureable concentration of interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2567515|NCT02565628|Primary|Number of Participants With Laboratory Abnormalities That Met Categorical Criteria for Concern (Without Regard to Baseline Abnormality)|Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute total neutrophils, absolute eosinophils, absolute basophils, absolute monocytes, and absolute lymphocytes),liver function(total bilirubin, direct bilirubin, aspartate, aspartate aminotransferase, alanine, alanine aminotransferase, alkaline phosphatase, total protein, and albumin), renal function (blood urea nitrogen, creatinine, and uric acid), electrolytes (sodium, potassium, chloride, calcium, and venous bicarbonate), clinical chemistry(glucose) ,and urinalysis (pH, qualitative glucose, qualitative protein, qualitative blood, qualitative ketones, qualitative bilirubin, nitrites, leukocyte esterase, urine urobilinogen, urine leukocyte, esterase and microscopy).|Screening, Days 1, 4, and 7, and follow-up visit|All enrolled participants who started treatment.|||participants|||Number
2567516|NCT02565628|Primary|Primary: Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern(Increase From Baseline)|Number of participants with ECG(standard 12-lead) meeting the following criteria was reported: Criterion A: maximum PR interval increase from baseline percentage change (PctChg)>=25/50%; Criterion B: maximum QRs complex increase from baseline PctChg >=50%; Criterion C: maximum QTcF interval increase from baseline 30<=change<60 msec; Criterion D: maximum QTcF interval increase from baseline change >=60 msec.|Screening, Days 1, 7, and 8, and follow-up visit|All enrolled participants who started treatment|||participants|||Number
2567517|NCT02565628|Primary|Number of Participants With Electrocardiogram (ECG) That Met Categorical Criteria for Concern (Absolute Value)|The number of participants with ECG absolute values meeting the following criteria was reported: Criterion A: maximum PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization) >=300 msec; Criterion B: maximum QRs complex(time from Q wave to the end of S wave, corresponding to ventricle depolarization) >=140 msec; Criterion C: maximum QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia's formula) 450-<480 msec; Criterion D: maximum QTcF interval 480-<500 msec; Criterion E: maximum QTcF interval (Fridericia's correction) >=500 msec|Screening, Days 1, 7, and 8, and follow-up visit|All enrolled participants who started treatment|||participants|||Number
2567518|NCT02565628|Primary|Number of Participants With Supine and Standing Vital Sign Abnormalities (Decrease From Baseline)|The number of participants with vital signs data of maximum decrease from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in supine systolic BP (SBP) >=30 mmHg; Criterion B: maximum decrease from baseline in standing SBP >=30 mmHg; Criterion C: maximum decrease from baseline in supine diastolic BP(DBP) >=20 mmHg; Criterion D: maximum decrease from baseline in standing diastolic BP(DBP) >=20 mmHg|Screening, Days -1, 1, 7 and 8, and follow-up visit|All enrolled participants who started treatment|||participants|||Number
2567519|NCT02565628|Primary|Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Increase From Baseline)|The number of participants with vital signs data of maximum increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in supine systolic BP (SBP) >=30 millimeters of mercury (mmHg); Criterion B maximum increase from baseline in standing SBP >=30 mmHg; Criterion C: maximum increase from baseline in supine diastolic BP(DBP) >=20 mmHg; Criterion D: maximum increase from baseline in standing diastolic BP(DBP) >=20 mmHg|Screening, Days -1, 1, 7 and 8, and follow-up visit|All enrolled participants who started treatment|||participants|||Number
2567520|NCT02565628|Primary|Number of Participants With Supine and Standing Vital Sign Abnormalities of Potential Clinical Concern (Absolute Values)|Number of participants with supine and standing vital signs data of absolute values meeting criteria of potential clinical concern. Absolute values were analyzed for supine/standing systolic blood pressure (SBP), supine/standing diastolic blood pressure (DBP), and supine/standing pulse rate. Number of participants with vital signs data meeting the following criteria was reported: (1) absolute supine SBP <90 millimeters of mercury (mmHg); (2) absolute standing SBP <90 mmHg; (3)absolute supine DBP<50mmHg; (4)absolute standing DBP<50mmHg (5) absolute supine pulse rate <40 beats per minute (bpm); (6) absolute supine pulse rate >120 bpm;(7) absolute standing pulse rate <40 bpm; (8) absolute standing pulse rate >140 bpm.|Screening, Days -1, 1, 7 and 8, and follow-up visit|All enrolled participants who started treatment|||participants|||Number
2567521|NCT02565628|Primary|Number of Participants With Treatment Emergent Adverse Events (All Causalities)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.|Day 1 to 28 calendar days after the last dose of investigational product|All enrolled participants who started treatment|||participants|||Number
2567522|NCT02565628|Primary|Number of Participants With New Onset and Worsening of Post-Baseline Suicidality.|Number of participants with new onset and worsening of post-baseline suicidality was reported|Day 8 or follow-up visit (Day 7 - 14 after last dose of PF-06669571)|All enrolled participants who started treatment|||participants|||Number
2567567|NCT02565381|Secondary|Nicotine Patch Use|Days of nicotine replacement therapy use in past week, repeatedly measured at the 8 assessment visits occurring on Fridays.|8 weeks|Participants with missing data at a given time point were excluded from calculation of mean past-week patch use at that time point.|||Days||Standard Deviation|Mean
2567523|NCT02565628|Primary|Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category by Study Visit on Day -2, Day 8 or Early Withdrawal, and Early Withdrawal/Follow-Up Visit|"The number of participants in each C-CASA category was mapped from Columbia-Suicide Severity Rating Scale (C-SSRS) data. C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (3) (Yes on preparatory acts or behavior), suicidal ideation (4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act or some intent to act, with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7) (Yes on Has subject engaged in non-suicidal self-injurious behavior)."|Day -2, Day 8, and follow-up visit (Day 7 - 14 after last dose of PF-06669571)|All enrolled participants who started treatment.|||participants|||Number
2567524|NCT02565628|Primary|Maximum Percent Change From Baseline in Movement Disorder Society-Sponsor Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III at Day 7.|The total MDS-UPDRS score is the most common method of evaluating the severity of Parkinson's disease across behaviors, activities of daily living, motor abilities, and other complications of Parkinson's disease. The MDS-UPDRS focuses primarily on measuring impairments associated with Parkinson's disease, with subsections organized according to motor and non-motor aspects of the disease. Part III assesses the motor signs of Parkinson's disease. Higher total scores indicate more severe motor signs of Parkinson's disease. Negative changes from baseline indicate improvement. MDS-UPDRS Part III total motor score is comprised of 33 sub-scores based on 18 items, several with right, left or other body distribution scores. Each question is anchored with five responses that are linked to commonly accepted clinical terms: 0 = normal, 1 = slight, 2 = mild, 3 = moderate and 4 = severe.|Day 7|All enrolled participants who started treatment.|||Percentage||Standard Error|Least Squares Mean
2567525|NCT02565615|Secondary|Precentage of Participants With Discontinuation From the Study by Dose Group Within Each CVD Risk Level|Percentage of participants who dropped out of the study and reasons for discontinuation were summarized by the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.|12 weeks of follow-up|"The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. Atorvastatin Unknown Dosage arm within each CVD risk level was exclude since incomplete information on medication."|||Percent|||Number
2567526|NCT02565615|Secondary|Precentage of Participants With Discontinuation From the Study for Overall|Percentage of participants who dropped out of the study and reasons for discontinuation were summarized overall.|12 weeks of follow-up|The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin. Number analyzed refers to number of participants evaluable for specified category.|||Percent|||Number
2567527|NCT02565615|Secondary|Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Creatine Kinase|The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for creatine kinase was reported according to the CVD risk stratification. Low-risk: 10 years CV risk <5%; Moderate-risk: 10 years CVD risk 5%~10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10%~15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.|Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)|"The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. Atorvastatin Unknown Dosage arm within each CVD risk level was exclude since incomplete information on medication."|||U/L||Standard Deviation|Mean
2567528|NCT02565615|Secondary|Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid|The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline for bilirubin, blood urea nitrogen, cholesterol (total), creatinine, triglycerides, uric acid data were reported according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.|Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)|"The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. Atorvastatin Unknown Dosage arm within each CVD risk level was exclude since incomplete information on medication."|||mg/dL||Standard Deviation|Mean
2567529|NCT02565615|Secondary|Change From Baseline for Clinical Laboratory by Dose Group Within Each CVD Risk Level-ALT and AST|The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for ALT and AST date were reported according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.|Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)|"The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. Atorvastatin Unknown Dosage arm within each CVD risk level was exclude since incomplete information on medication."|||IU/L||Standard Deviation|Mean
2567530|NCT02565615|Secondary|Change From Baseline for Clinical Laboratory Overall- Creatine Kinase|The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for creatine kinase was reported.|Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)|The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin. Number analyzed refers to number of participants evaluable for specified category.|||U/L||Standard Deviation|Mean
2567568|NCT02565381|Secondary|Counseling Visit Attendance|Percentage of 8 counseling visits attended.|8 weeks||||percentage of visits||Standard Deviation|Mean
2567531|NCT02565615|Secondary|Change From Baseline for Clinical Laboratory Overall- Bilirubin, Blood Urea Nitrogen, Cholesterol, Creatinine, Triglycerides, Uric Acid|The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline for bilirubin, blood urea nitrogen, cholesterol (total), creatinine, triglycerides, uric acid data were reported.|Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)|The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin. Number analyzed refers to number of participants evaluable for specified category.|||mg/dL||Standard Deviation|Mean
2567532|NCT02565615|Secondary|Change From Baseline for Clinical Laboratory Overall- ALT and AST|The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline for ALT and AST date were reported.|Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)|The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin. Number analyzed refers to number of participants evaluable for specified category.|||IU/L||Standard Deviation|Mean
2567533|NCT02565615|Secondary|Number of Participants With Elevated Abnormal Laboratory in CK, ALT and AST by Dose Group Within Each CVD Risk|The elevated abnormal laboratory data was summarized: significant elevated CK: CK values 10 times the upper limit of normal; Persistent elevation in alanine aminotransferase, aspartate aminotransferase, or both: 2 consecutive measurements obtained 4 to 10 days apart that was more than 3 times the upper limit of the normal range according to the CVD risk stratification. Low-risk: 10 years CV risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.|Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)|"The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. Atorvastatin Unknown Dosage arm within each CVD risk level was exclude since incomplete information on medication."|||Participants|||Count of Participants
2567534|NCT02565615|Secondary|Number of Participants With Elevated Abnormal Laboratory in Creatine Kinanse (CK), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) for Overall|The elevated abnormal laboratory data was summarized: significant elevated CK: CK values 10 times the upper limit of normal; Persistent elevation in alanine aminotransferase, aspartate aminotransferase, or both: 2 consecutive measurements obtained 4 to 10 days apart that was more than 3 times the upper limit of the normal range.|Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)|The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin. Number analyzed refers to number of participants evaluable for specified category.|||Participants|||Count of Participants
2567535|NCT02565615|Secondary|Number of Participants With Adverse Events of Special Interest (AESI) by Dose Group Within Each CVD Risk Level|AESI were categorized as muscle symptoms: myalgia, fatigue, weakness, creatine kinase (CK) values 10 times the upper limit of normal, or rhabdomyolysis, and muscle damage based on significant elevated CK; major cardiovascular events: myocardial infarction, stroke, unstable angina requiring re-hospitalization, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting; Death according to the CVD risk stratification. Low-risk: 10 years CV risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CV risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.|Baseline (Day 1) to Week 12 (±28 Days) or any unplanned visit (if occurred: any date during Week 4 to Week 16)|"The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. Atorvastatin Unknown Dosage arm within each CVD risk level was exclude since incomplete information on medication."|||Participants|||Count of Participants
2567536|NCT02565615|Secondary|Number of Participants With Adverse Events of Special Interest (AESI) for Overall|AESI were categorized as muscle symptoms: myalgia, fatigue, weakness, creatine kinase (CK) values 10 times the upper limit of normal, or rhabdomyolysis, and muscle damage based on significant elevated CK; major cardiovascular events: myocardial infarction, stroke, unstable angina requiring re-hospitalization, revascularization with either percutaneous coronary intervention or coronary-artery bypass grafting; Death.|Baseline to Week 12 (±28 Days) or any unplanned visit (if occurred:any date during Week 4 to Week 16)|The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin.|||Participants|||Count of Participants
2567537|NCT02565615|Secondary|Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) by Dose Group Within Each CVD Risk Level|All causalities adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage; Treatment-related AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; The event has a causal relationship with the treatment or usage. The AEs were categorized by the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.|Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )|"The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. Atorvastatin Unknown Dosage arm within each CVD risk level was exclude since incomplete information on medication."|||Participants|||Count of Participants
2567563|NCT02565485|Primary|Incidence of New-onset Category II or III Fetal Heart Rate Tracings|Each fetal heart rate tracing was evaluated in 15 min increments from the completion of epidural placement and initial dose administration. ACOG Category I, II, and III was assigned to each 15 min increment.|First 60 minutes following epidural placement||||Participants|||Count of Participants
2567564|NCT02565381|Other Pre-specified|Use of Text Messaging Program|Text messaging group only: number who enrolled in SmokefreeTXT, number who replied to query texts sent by SmokefreeTXT.|8 weeks||||Participants|||Count of Participants
2567538|NCT02565615|Secondary|Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-related) for Overall|All causalities adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage; Treatment-related AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; The event has a causal relationship with the treatment or usage.|Baseline to Week 12 (±28 days) or any unplanned visit (if occurred: any date during Week 4 to Week 16 )|The Safety Analysis population included all participants who received at least 1 dose of study drug atorvastatin. Number analyzed refers to number of participants evaluable for specified category.|||Participants|||Count of Participants
2567539|NCT02565615|Secondary|Study Drug Exposure Within Each CVD Risk Group -Daily Dose|Daily dose was calculated by total dose divided by the total days of receiving atorvastatin according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.|Day 1 to Week 12|"The analysis set included all participants who received at least 1 dose of atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. Atorvastatin Unknown Dosage arm within each CVD risk level was exclude since incomplete information on medication."|||mg/day||Standard Deviation|Mean
2567540|NCT02565615|Secondary|Study Drug Exposure Within Each CVD Risk Group - Total Dose and Week 12 Dose|Atorvastatin total dose: calculated from Day 1 to Week 12 or last dose; Week 12 dose: dose taken at Week 12 according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.|Day 1 to Week 12|"The analysis set included all participants who received at least 1 dose of atorvastatin and only counted the participants at the dose levels: ≤10 mg, 20 mg, 30 mg and 40 mg. Atorvastatin Unknown Dosage arm within each CVD risk level was exclude since incomplete information on medication."|||mg||Standard Deviation|Mean
2567541|NCT02565615|Secondary|Study Drug Exposure for Overall - Daily Dose|Daily dose was calculated by total dose divided by the total days of receiving atorvastatin.|Day 1 to Week 12|The analysis set included all participants who received at least 1 dose of atorvastatin and evaluable for specified category (daily dose).|||mg/day||Standard Deviation|Mean
2567542|NCT02565615|Secondary|Study Drug Exposure for Overall - Total Dose and Week 12 Dose|Atorvastatin total dose: calculated from Day 1 to Week 12 or last dose day; Week 12 dose: dose taken at Week 12|Day 1 to Week 12|"The analysis set included all participants who received at least 1 dose of atorvastatin. Atorvastatin Unknown Dosage did not have Week 12 dose. Number analyzed refers to number of participants evaluable for specified category."|||mg||Standard Deviation|Mean
2567543|NCT02565615|Secondary|Percent Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Level|Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG) according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Percent change from baseline was reported.|Baseline to Week 12|"The full analysis set (FAS) analysis population included all enrolled in the study that received at least 1 dose of atorvastatin and completed 12- week follow-up. Atorvastatin Unknown Dosage arm did not meet FAS criteria. Number analyzed refers to number of participants evaluable for specified category."|||Percent Change||Standard Deviation|Mean
2567544|NCT02565615|Secondary|Change From Baseline for Lipid Parameters at Week 12 Within Each CVD Risk Group|Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG) according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes. The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from baseline data was reported.|Baseline to Week 12|"The full analysis set (FAS) analysis population included all enrolled in the study that received at least 1 dose of atorvastatin and completed 12- week follow-up. Atorvastatin Unknown Dosage arm did not meet FAS criteria. Number analyzed refers to number of participants evaluable for specified category."|||mg/dL||Standard Deviation|Mean
2567545|NCT02565615|Secondary|Percent Change From Baseline for Lipid Parameters at Week 12 for Overall|Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG). The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Percent change from baseline was reported.|Baseline to Week 12|"The full analysis set (FAS) analysis population included all enrolled in the study that received at least 1 dose of atorvastatin and completed 12- week follow-up. Atorvastatin Unknown Dosage arm did not meet FAS criteria. Number analyzed refers to number of participants evaluable for specified category."|||Percent Change (%)||Standard Deviation|Mean
2567546|NCT02565615|Secondary|Change From Baseline for Lipid Parameters at Week 12 for Overall|Lipid parameters included LDL-C, High-Density Lipoprotein Cholesterol (HDL-C), Total Cholesterol (TC), and Triglycerides (TG). The baseline data was collected within 1 month before taking atorvastatin or within 24 hours after starting atorvastatin. Change from Baseline data was reported.|Baseline to Week 12|"The full analysis set (FAS) analysis population included all enrolled in the study that received at least 1 dose of atorvastatin and completed 12- week follow-up. Atorvastatin Unknown Dosage arm did not meet FAS criteria. Number analyzed refers to number of participants evaluable for specified category."|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
2567565|NCT02565381|Other Pre-specified|Mobile Phone Retention|Percentage of participants who still have their mobile phone at the end of the study.|8 weeks||||Participants|||Count of Participants
2567566|NCT02565381|Other Pre-specified|Recruitment Time|Total time to recruit, enroll, and randomize 75 study participants.|Until target number of participants is reached; anticipate ~6 months||||months|||Number
2567547|NCT02565615|Primary|Achievement Rate for LDL-C by Dose Group Within Each Cardiovascular Disease (CVD) Risk Level|Achievement Rate was defined as ratio of number of participants who achieved LDL-C target value to number of participants who completed 12-week follow up according to the CVD risk stratification. Low-risk: 10 years CVD risk <5%; Moderate-risk: 10 years CVD risk 5% to 10%; High-risk: Coronary Heart Disease (CHD) or CHD risk equivalents, or 10 years CVD risk 10% to 15%; Very-high risk: acute coronary syndromes, or ischemic cardiovascular disease combined with diabetes.|12 weeks|"The full analysis set (FAS) analysis population included all enrolled in the study that received at least 1 dose of atorvastatin and completed 12- week follow-up. Atorvastatin Unknown Dosage arm did not meet FAS criteria. Number analyzed refers to number of participants evaluable for specified category."|||Ratio||95% Confidence Interval|Number
2567548|NCT02565615|Primary|Achievement Rate for Low Density Lipoprotein-Cholesterol (LDL-C) for Overall|Achievement Rate was defined as ratio of number of participants who achieved LDL-C target value to number of participants who completed 12-week follow up.|12 weeks|"The full analysis set (FAS) analysis population included all enrolled in the study that received at least 1 dose of atorvastatin and completed 12- week follow-up. Atorvastatin Unknown Dosage arm did not meet FAS criteria."|||Ratio||95% Confidence Interval|Number
2567549|NCT02565576|Secondary|Plasma CFZ533 Concentration at Steady State Conditions (Week 17)||week 17|pharmacokinetic set, participants treated with CFZ533 only, with measure|||micrograms/mL||Standard Deviation|Mean
2567550|NCT02565576|Secondary|Total Soluble CD40 (sCD40) in Plasma|PD|week1, week 25|pharmacodynamic analysis set, participants with measure|||ng/ml||Standard Deviation|Mean
2567551|NCT02565576|Secondary|Free CD40 on B Cells|CD40 receptor occupancy by CFZ533 in peripheral blood was assessed by flow cytometry analysis, measuring free or total CD40 receptors on whole blood B cells. Free CD40 on CD19-positive B cells, using PE-conjugated CFZ533 whose binding was prevented by bound, unconjugated CFZ533 (drug bound to CD40 on peripheral blood B cells). The more CD40 was occupied by unlabeled CFZ533, the less binding of labeled CFZ533, manifest as a lower mean fluorescence intensity (MFI) of CD40 on B cells. MFI from free CD40 on B cells was converted into Molecules of Equivalent Soluble Fluorochrome (MESF) using PE-MESF beads.|week 1, week 25|Pharmacodynamic analysis set, participants with measure|||MESF||Standard Deviation|Mean
2567552|NCT02565576|Secondary|Mean Change From Baseline in the Myasthenia Gravis Quality of Life (MG QOL-15)|The MG-QOL15 is a 15-item survey, completed by MG patients and it is designed to assess some aspects of quality of life (QoL) related to MG (Burns et al 2011) e.g. assesment of mood, eating, speaking, driving a car etc.. The higher score on MG-QOL15 scale (0-60 points) indicates worse QoL.|week 25|PD analysis set, participants with measure|||score||Standard Deviation|Mean
2567553|NCT02565576|Secondary|Mean Changes From Baseline in the QMG Score at Week 49|QMG (quantitative myasthenia gravis) score is an established validated measure of disease severity used in MG trials (Jaretzki et al 2000). The scoring system is based on quantitative testing of sentinel muscle groups by means of a 4 point scale ranging from 0 (no symptoms) to 3 (severe symptoms). The scale measures ocular, bulbar, respiratory, and limb function, grading each finding, and the total score ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits) (Sharshar et al 2000, Bedlack et al 2005). A decrease in the QMG score indicated an improvement. Results given as a change in the score as compared from baseline|week 49|PD analysis set, participants with measure|||score on a scale||Standard Deviation|Mean
2567554|NCT02565576|Secondary|Mean Change From Baseline in the Myasthenia Gravis-specific Activities of Daily Living Scale (MG-ADL)|The MG-ADL is an 8-item survey to assess functional performance of daily activities that are sometimes impaired by MG e.g. talking, breathing, swallowing etc. (Muppidi et al 2011). The higher score on MG-ADL scale (0-24 points) indicates worse functional performance of daily activities.|week 25|PD analysis set, participants with measure|||score||Standard Deviation|Mean
2567555|NCT02565576|Secondary|Number of Patients Who Discontinued Due to Inefficacy or Worsening||week 49|Full analysis set|||Participants|||Count of Participants
2567556|NCT02565576|Secondary|Proportion of Patients Intolerant to Steroid Taper||week 49|this data was not collected. No analysis could be performed for this outcome measure.|||Participants|||Count of Participants
2567557|NCT02565576|Secondary|Proportion of Patients With Improvement or Worsening by ≥ 3 Points in the QMG Score|QMG score is an established validated measure of disease severity used in MG trials (Jaretzki et al 2000). The scoring system is based on quantitative testing of sentinel muscle groups by means of a 4 point scale ranging from 0 (no symptoms) to 3 (severe symptoms). The scale measures ocular, bulbar, respiratory, and limb function, grading each finding, and the total score ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits) (Sharshar et al 2000, Bedlack et al 2005).|at week 49|PD analysis set, participants with measure|||Participants|||Count of Participants
2567558|NCT02565576|Secondary|Mean Changes From Baseline in the Myasthenia Gravis Composite (MGC) Score. Posterior Median Was Used as Measure Type.|"The Myasthenia Gravis Composite (MGC) score is another key efficacy outcome measure, ranging from 0 to 50. It is reliable and demonstrates concurrent and longitudinal construct validity in the MG practice care setting (Burns et al 2010). The MGC scale covers 10 important functional domains most frequently involved in patients with MG. The proportion of bulbar and respiratory items reflect the clinical importance of these domains in the disease, and are appropriately weighted.~The assessment of each of the 10 test items provides immediate insight into the status of that particular functional domain. A decrease in this score shows an improvement."|From baseline to week 49||||score||90% Confidence Interval|Median
2567559|NCT02565576|Primary|Mean Change From Baseline in the Quantitative Myastenia Gravis (QMG) Score at Week 25. Posterior Median Was Used as Measure Type.|QMG score is an established validated measure of disease severity used in MG trials (Jaretzki et al 2000). The scoring system is based on quantitative testing of sentinel muscle groups by means of a 4 point scale ranging from 0 (no symptoms) to 3 (severe symptoms). The scale measures ocular, bulbar, respiratory, and limb function, grading each finding, and the total score ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits) (Sharshar et al 2000, Bedlack et al 2005).|week 25|pharmacodynamic (PD) analysis set, participants with non-detectable AChR or MuSK autoantibodies were excluded from the PD analysis set.|||score||90% Confidence Interval|Median
2567560|NCT02565485|Secondary|Adverse Events (Pulmonary Edema)|Pulmonary edema occurring after preload bolus through delivery was considered an adverse event.|Duration of intrapartum course||||Participants|||Count of Participants
2567570|NCT02565381|Secondary|Change in Behavioral Health|Past-month drug use severity (score range 0-1), past-month alcohol use severity (score range 0-1), and past-month psychiatric severity (0-1) were each assessed with the Addiction Severity Index (ASI) - 5th Edition, at baseline and at the 10th and 14th study visits. For each ASI measure, higher scores represent greater drug, alcohol, or psychiatric severity. Changes in ASI scores between baseline and 4 or 8 weeks can range from -1 to +1. When interpreting changes in scores, negative values indicate decreases in scores from baseline to 4 or 8 weeks, and positive values indicate increases in scores from baseline to 4 or 8 weeks.|4 weeks and 8 weeks|Participants with missing data at a particular time point are excluded from calculation of mean change in ASI scores at that time point.|||units on a scale||Standard Deviation|Mean
2567571|NCT02565381|Secondary|Change in Cigarette Consumption|Changes in the average number of cigarettes per day relative to baseline, defined by self-report and repeatedly assessed at the 8 assessment visits occurring on Fridays.|Once per week for 8 weeks|Participants with missing data at a given time point are excluded from calculation of mean changes in cigarette consumption for that time point.|||Cigarettes per day||Standard Deviation|Mean
2567572|NCT02565381|Secondary|Smoking Abstinence at End of Study|Point-prevalence smoking abstinence, defined as an exhaled carbon monoxide level <8ppm, at the 14th (final) study visit.|8 weeks||||Participants|||Count of Participants
2567573|NCT02565381|Secondary|Percentage of Visits Abstinent of Smoking|Percentage of 14 assessment visits at which a participant is abstinent of smoking, defined as an exhaled carbon monoxide level <8ppm.|8 weeks|Participants with missing data at a given time point were assumed non-abstinent at that time point.|||percentage of visits||Standard Deviation|Mean
2567574|NCT02565381|Primary|Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks|The primary outcome is a repeated-measures assessment of smoking abstinence, defined as an exhaled carbon monoxide <8ppm and assessed 14 times over the 8-week study period (3 times/week for the first 2 weeks, 2 times/week for the next 2 weeks, and once every week for the last 4 weeks)|Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study period|Participants with missing data at a given time point were assumed non-abstinent at that time point.|||Participants|||Count of Participants
2567575|NCT02565147|Other Pre-specified|Index Of Microcirculatory Resistance (IMR)|"IMR, a predictor of clinical outcome, is a readily available, quantitative, and reproducible method for invasively assessing coronary microvascular function. It is measured using the thermodilution technique and defined as mean distal coronary pressure, expressed in millimeters (mm) of mercury (Hg), multiplied by the mean hyperemic transit time (s) (mmHg*s). Higher IMR values indicate poorer microcirculation and are associated with a worse clinical outcome. A cutoff point of 32 (associated with better clinical outcomes) was selected as the threshold. Only participants at study locations with previous experience in IMR measurements participated in this sub study.~The number of participants and their mean reported IMR at the end of PPCI are presented."|1 day (end of PPCI)|All participants enrolled into the randomized trial (Intent-to-treat [ITT] Population) who took part in the IMR sub study (IMR-ITT).|||mmHg*s||Standard Deviation|Mean
2567576|NCT02565147|Secondary|Death At Day 90|Participant survival during the clinical follow-up period is presented as the number of participants with reported death at 90 days post PPCI.|90 days post PPCI|All enrolled participants who underwent successful PPCI and CMR without major protocol deviations (Per-Protocol Population).|||Participants|||Number
2567577|NCT02565147|Secondary|Percentage of Participants With In-Hospital Net Adverse Cardiac Events (NACE) At Day 5|"The NACE at 5 days is the composite of major bleeding (Bleeding Academic Research Consortium Type 3 or greater [BARC type ≥3]), death, re-infarction, and ischaemia driven revascularization (IDR).~In brief, BARC ≥3 includes: Type 3a-3c, clinical, laboratory, and/or imaging evidence of bleeding; Type 4, coronary artery bypass grafting-related bleeding; Type 5, fatal bleeding that directly results in death that is either clinically suspicious or is confirmed as the cause of death.~A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint.~The percentage of participants with in-hospital NACE up to Day 5 is presented."|5 days post PPCI or at discharge, whichever occurs first|All enrolled participants who underwent successful PPCI and CMR without major protocol deviations (Per-Protocol Population).|||Percentage of Participants|||Number
2567578|NCT02565147|Secondary|TIMI Flow And Myocardial Blush Grade (MBG) At End Of PPCI|"TIMI flow (grade 0-3) is an angiographic determination of briskness of epicardial coronary blood flow: TIMI 0 flow (no perfusion); TIMI 1 flow (penetration without perfusion); TIMI 2 flow (partial reperfusion); TIMI 3 flow (complete perfusion/normal flow).~MBG (grade 0-3) is an angiographic method for determination of blood flow in the distal myocardial vascular bed. Blush grades: 0 = failure of dye to enter the micro-vasculature; 1 = dye slowly enters but fails to exit the micro-vasculature; 2 = delayed entry and exit of dye from the micro-vasculature; 3 = normal entry and exit of dye from the micro-vasculature. Blush that is only mildly intense throughout the washout phase, but fades minimally, is also classified as grade 3.~The number of participants and their mean reported TIMI flow and MBG grades at the end of PPCI are presented."|1 day (end of PPCI)|All enrolled participants who underwent successful PPCI and CMR without major protocol deviations (Per-Protocol Population) and participants with a detectable TIMI Flow and MBG at the end of PPCI.|||Units on a Scale||Standard Deviation|Mean
2567579|NCT02565147|Secondary|CMR Assessment Of LVEF At Day 90|Percentage of cardiac LVEF as assessed by CMR. LVEF is a measurement of the percentage of blood ejected out of the left ventricle with each contraction. The number of participants and their mean reported LVEF, as a percentage of blood, at Day 90 are presented.|90 days post PPCI|All enrolled participants who underwent successful PPCI and CMR without major protocol deviations (Per-Protocol Population) and participants with a successful CMR assessment of LVEF at Day 90.|||Percentage of Blood||Standard Deviation|Mean
2567580|NCT02565147|Secondary|CMR Assessment Of Left Ventricular Ejection Fraction (LVEF) At Day 5|Percentage of cardiac LVEF as assessed by CMR. LVEF is a measurement of the percentage of blood ejected out of the left ventricle with each contraction. The number of participants and their mean reported LVEF, as a percentage of blood, at Day 5 are presented.|5 days post PPCI|All enrolled participants who underwent successful PPCI and CMR without major protocol deviations (Per-Protocol Population).|||Percentage of Blood||Standard Deviation|Mean
2567581|NCT02565147|Secondary|CMR Assessment Of Micro-vascular Obstruction (MVO) At Day 5|"Early and late assessment of MVO, expressed as grams, as assessed by CMR. MVO is an established complication of coronary reperfusion therapy for acute myocardial infarction. MVO occurs in the setting of reperfusion following prolonged myocardial ischemia and provides incremental prognostic information beyond infarct size, to which it is related. Early MVO is a prolonged (approximately 60 s) perfusion deficit in dynamic gadolinium (Gd) first-pass images that is determined within 2 minutes (min) of administration of the Gd-based contrast agent. Late MVO is usually assessed as a hypointense infarct core on late-Gd-enhancement images acquired 10 min after contrast administration.~The number of participants and their mean reported early and late MVO, as grams, at Day 5 are presented."|5 days post PPCI|All enrolled participants who underwent successful PPCI and CMR without major protocol deviations (Per-Protocol Population) and participants with a successful CMR assessment of MVO.|||Grams||Standard Deviation|Mean
2567582|NCT02565147|Secondary|CMR Assessment Of Myocardial Salvage Index (MSI) At Day 5|MSI is a CMR-derived parameter of myocardial recovery and treatment efficacy that allows comparisons among infarcts of different sizes. MSI is calculated as the difference between the area at risk (AAR) and the final infarct size, divided by the AAR, and it is expressed as a percentage of AAR. An MSI of 100% indicates maximum treatment success, whereas an MSI of 0% indicates no treatment benefit. The number of participants and their mean-reported MSI at Day 5 are presented.|5 days post PPCI|All enrolled participants who underwent successful PPCI and CMR without major protocol deviations (Per-Protocol Population) and participants with a successful CMR assessment of MSI.|||Percentage of AAR||Standard Deviation|Mean
2567583|NCT02565147|Primary|CMR Assessment Of Infarct Size At Day 5|Size of cardiac infarct, expressed as grams, as assessed by CMR. The use of CMR has dramatically improved the ability for accurate infarct size estimations and is therefore currently considered the gold standard. The number of participants and their mean reported infarct size, as grams, at Day 5 are presented.|5 days post PPCI|All enrolled participants who underwent successful PPCI and CMR without major protocol deviations (Per-Protocol Population).|||Grams||Standard Deviation|Mean
2567584|NCT02565108|Primary|PK: Geometric Mean Ratios Of CLB And N-CLB For AUCtau On Day 33 Compared With Day 1|The Day 33 compared to Day 1 geometric mean ratios of CLB and N-CLB were calculated for AUCtau to look for evidence of drug-drug interactions between GWP42003-P/Placebo and CLB and between GWP42003-P/Placebo and N-CLB. A standard 90% CI approach for the between time point ratios of geometric means of AUCtau was carried out on a logarithmic scale using a linear mixed effect model. The no-effect boundary was set between 0.5 and 2.0, and if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0], a lack of meaningful effect was declared. Estimates were back transformed to provide summaries on the original scale. The model included a fixed effect term for PK assessment period. An unstructured covariance matrix was used. Kenward and Roger's method was used to calculate the denominator degrees of freedom for the fixed effects.|Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33|PK Set: All participants who received at least 1 dose of GWP42003-P or placebo, who had not reduced their CLB dose between Day 1 and Day 33, and who provided some on-treatment data.|||Ratio||90% Confidence Interval|Number
2567585|NCT02565108|Secondary|Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)|"A TEAE was defined as an adverse event with an onset date on or after the first dose of IMP. If an adverse event (AE) had a partial onset date and it was unclear from the partial date (or the stop date) whether the AE started prior to or following the first dose of IMP then the AE was considered a TEAE. The number of participants who experienced 1 or more severe TEAEs after screening up to Day 71.~A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module."|Postdose on Day 2 up to Safety follow-up (Day 71)|Safety Set: all participants who received at least 1 dose of IMP (GWP42003-P or placebo). Participants were analyzed according to the treatment they received.|||Participants|||Count of Participants
2567586|NCT02565108|Primary|PK: Geometric Mean Ratios Of CLB And N-CLB For Cmax On Day 33 Compared With Day 1|The Day 33 compared to Day 1 geometric mean ratios of CLB and N-CLB were calculated for Cmax to look for evidence of drug-drug interactions between GWP42003-P/Placebo and CLB and between GWP42003-P/Placebo and N-CLB. A standard 90% confidence interval (CI) approach for the between time point ratios of geometric means of Cmax was carried out on a logarithmic scale using a linear mixed effect model. The no-effect boundary was set between 0.5 and 2.0, and if the 90% CI for the ratio of the geometric means of a PK variable fell within the interval [0.5, 2.0], a lack of meaningful effect was declared. Estimates were back transformed to provide summaries on the original scale. The model included a fixed effect term for PK assessment period. An unstructured covariance matrix was used. Kenward and Roger's method was used to calculate the denominator degrees of freedom for the fixed effects.|Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33|PK Set: All participants who received at least 1 dose of GWP42003-P or placebo, who had not reduced their CLB dose between Day 1 and Day 33, and who provided some on-treatment data.|||Ratio||90% Confidence Interval|Number
2567587|NCT02565108|Primary|PK: Area Under The Plasma Concentration‑Time Curve Over A Dosing Interval, Where Tau Is The Dosing Interval (AUCtau) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33|"The AUCtau of CLB and its primary metabolite N-CLB was measured on Day 1 (before first GWP42003-P dose; participants were taking CLB only) and Day 33 (following 21 days of GWP42003-P or placebo maintenance; participants were taking CLB and GWP42003-P or CLB and placebo). PK samples were taken at time points relative to the morning dose of CLB, as follows: Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 12 h, and 24 h.~One participant in the placebo group was excluded from the PK set because placebo was administered on Day 1, after predose sampling. Six participants in the GWP42003-P group were excluded from the PK set because of GWP42003-P and/or CLB dose modification, discontinuation of IMP, discontinuation from trial, or administration of incorrect IMP dose."|Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33|PK Set: All participants who received at least 1 dose of GWP42003-P or placebo, who had not reduced their CLB dose between Day 1 and Day 33, and who provided some on-treatment data.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2567607|NCT02564887|Secondary|Swallowing Impairment-Objective|"functional oral intake scale (FOIS) The Functional Oral Intake Scale is an ordinal scale that is used to assess the current status and meaningful change in the oral intake.~Minimum - 1 Maximum - 7 Higher is better Score reported is the overall score at that point in time and not a change from baseline."|8 week||||score on a scale||Full Range|Mean
2567588|NCT02565108|Primary|PK: Time To The Maximum Plasma Concentration (Tmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33|"The tmax of CLB and its primary metabolite N-CLB was measured on Day 1 (before beginning GWP42003-P treatment; participants were taking CLB only) and Day 33 (following 21 days of GWP42003-P or placebo maintenance; participants were taking CLB and GWP42003-P or CLB and placebo). PK samples were taken at time points relative to the morning dose of CLB, as follows: Predose, 15 min, 30 min, 1 h, 1.5 h, 2 h, 4 h, 6 h, 12 h, and 24 h.~One participant in the placebo group was excluded from the PK set because placebo was administered on Day 1, after predose sampling. Six participants in the GWP42003-P group were excluded from the PK set because of GWP42003-P and/or CLB dose modification, discontinuation of IMP, discontinuation from trial, or administration of incorrect IMP dose."|Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33|PK Set: All participants who received at least 1 dose of GWP42003-P or placebo, who had not reduced their CLB dose between Day 1 and Day 33, and who provided some on-treatment data.|||h||Full Range|Median
2567589|NCT02565108|Primary|Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of CLB And N-CLB With GWP42003-P Treatment, Days 1 And 33|"The Cmax of CLB and its primary metabolite N-desmethylclobazam (N-CLB) was measured on Day 1 (before beginning GWP42003-P treatment; participants were taking CLB only) and Day 33 (following 21 days of GWP42003-P or placebo maintenance; participants were taking CLB and GWP42003-P or CLB and placebo). PK samples were taken at time points relative to the morning dose of CLB, as follows: Predose, 15 minutes (min), 30 min, 1 hour (h), 1.5 h, 2 h, 4 h, 6 h, 12 h, and 24 h.~One participant in the placebo group was excluded from the PK set because placebo was administered on Day 1, after predose sampling. Six participants in the GWP42003-P group were excluded from the PK set because of GWP42003-P and/or CLB dose modification, discontinuation of IMP, discontinuation from trial, or administration of incorrect IMP dose."|Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h postdose on Days 1 and 33|PK Set: All participants who received at least 1 dose of GWP42003-P or placebo, who had not reduced their CLB dose between Day 1 and Day 33, and who provided some on-treatment data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2567590|NCT02564952|Primary|Number Of Participants Who Experienced Severe OLE-Emergent AEs|"An OLE-emergent AE was defined as an AE with an onset date after the first dose of IMP in the OLE phase of the study. The number of participants who experienced 1 or more severe OLE-emergent AEs after the first dose of IMP in the OLE phase of the study up to the Safety follow-up visit (28 [± 3] days following the last dose of IMP) is presented.~A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module."|Postdose on Day 2 of Visit 4 up to Safety follow-up (28 [± 3] days following the last dose of IMP)|The OLE population included all participants who completed the double-blind phase and entered the OLE phase of the study. The OLE population was the primary analysis set for all safety endpoints reported.|||Participants|||Count of Participants
2567591|NCT02564926|Primary|Adjusted Mean Changes From Baseline in Percentage of Total Body Fat Assessed by DXA Scan|Adjusted mean percent changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment|From baseline to Week 52||||percent change||95% Confidence Interval|Least Squares Mean
2567592|NCT02564926|Secondary|Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52|Adjusted Mean Change in High Sensitivity C-Reactive Protein (hsCRP) at Week 52|From baseline to Week 52||||mg/L||95% Confidence Interval|Least Squares Mean
2567593|NCT02564926|Secondary|Adjusted Mean Change in Adinopectin at Week 52|Adjusted Mean Change in Adinopectin at Week 52|From baseline to Week 52||||ng/mL||95% Confidence Interval|Least Squares Mean
2567594|NCT02564926|Secondary|Adjusted Mean Change in Lean Body Mass at Week 52|Adjusted Mean Change in Lean Body Mass at Week 52|From baseline to Week 52||||Kg||95% Confidence Interval|Least Squares Mean
2567595|NCT02564926|Secondary|Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52|Adjusted Mean Change in Visceral to Subcutaneous Adipose Tissue Ratio at Week 52|From baseline to Week 52||||ratio||95% Confidence Interval|Least Squares Mean
2567596|NCT02564926|Secondary|Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) Area at Week 52|Adjusted Mean Change in Subcutaneous Adipose Tissue (SAT) area at Week 52|From baseline to Week 52||||cm^2||95% Confidence Interval|Least Squares Mean
2567597|NCT02564926|Secondary|Adjusted Mean Change in Visceral Adipose Tissue (VAT) Area at Week 52|Adjusted Mean Change in Visceral Adipose Tissue (VAT) area at Week 52|From baseline to Week 52||||cm^2||95% Confidence Interval|Least Squares Mean
2567598|NCT02564926|Secondary|Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52|Adjusted Mean Change in Diastolic Blood Pressure (DBP) at Week 52|From baseline to Week 52||||mmHg||95% Confidence Interval|Least Squares Mean
2567599|NCT02564926|Secondary|Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52|Adjusted Mean Change in Systolic Blood Pressure (SBP) at Week 52|From baseline to Week 52||||mmHg||95% Confidence Interval|Least Squares Mean
2567600|NCT02564926|Secondary|Adjusted Mean Change in Body Mass Index (BMI) at Week 52|Adjusted Mean Change in Body Mass Index (BMI) at Week 52|From baseline to Week 52||||kg/m^2||95% Confidence Interval|Least Squares Mean
2567601|NCT02564926|Secondary|Adjusted Mean Change in Waist Circumference at Week 52|Adjusted Mean Change in Waist Circumference at Week 52|From baseline to Week 52||||cm||95% Confidence Interval|Least Squares Mean
2567602|NCT02564926|Secondary|Adjusted Mean Change in Total Body Weight at Week 52|Adjusted Mean Change in Total Body Weight at Week 52|From baseline to Week 52||||kg||95% Confidence Interval|Least Squares Mean
2567603|NCT02564926|Secondary|Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52|Adjusted Mean Change in Fasting Blood Sugar (FBS) at Week 52|From baseline to Week 52||||mg/dL||95% Confidence Interval|Least Squares Mean
2567604|NCT02564926|Secondary|HbA1c <7.0% at Week 52|HbA1c <7.0% at Week 52|52 weeks||||Participants|||Count of Participants
2567605|NCT02564926|Secondary|Adjusted Mean Change in HbA1c at Week 52|Adjusted Mean Change in HbA1c at Week 52|From baseline to Week 52||||percentages||95% Confidence Interval|Least Squares Mean
2567606|NCT02564926|Primary|Adjusted Mean Changes From Baseline in Total Body Fat Mass by DXA Scan|Adjusted mean changes in total body fat mass from baseline using DXA scan in 52 weeks after the start of the treatment|From baseline to Week 52||||grams||95% Confidence Interval|Least Squares Mean
2568200|NCT02556918|Secondary|Amount of Subcutaneous (SC) Insulin in Intensive Care Unit (ICU) 48 Hours|Amount of subcutaneous (SC) insulin in intensive care unit (ICU) 48 hours during recovery period.|48 hours during recovery period||||units||Standard Deviation|Mean
2567609|NCT02564887|Secondary|Swallowing Impairment-Self Report|"Patient perceived outcome measure related to their view of their swallowing problem/difficulties at that point in time.~Eating Assessment Tool (EAT-10). Minimum score 0 Maximum score 40 Higher score is worse Number reported is final overall score"|8 week||||score on scale||Full Range|Mean
2567610|NCT02564887|Secondary|Change Over Time of Pharyngeal Residue After Swallowing|"The change in pharyngeal retention measured using the normalized residue ratio scale (NRR) is being assessed.~The NRR quantifies the amount of residue remaining in the valleculae and pyriform sinuses after a swallow as a ratio of the total area of each of these two pharyngeal spaces.~Value represents the area of space that is occupied by barium at the end of a swallow.~The change from baseline to 8 weeks is documented.~A positive change (+) is worsening of symptoms. A negative change (-) is bettering of symptoms."|8 week|"While the Traditional Therapy Only and the Traditional Therapy with IOPI groups each contain n=10 participants, only 6 swallowing evaluations underwent evaluation for this particular measure.~Detailed swallowing evaluations were only performed in participants who were felt to be safe to undergo the evaluations."|||units on a scale||Full Range|Mean
2567611|NCT02564887|Secondary|Airway Protection During Swallowing|"Penetration-aspiration scale score of the modified barium swallow (MBS) data for small, thin liquids Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled.~Minimum 1 Maximum 8 Lower is better The score being evaluated is an absolute score at the time of collection and not the change over time."|8 week|Not all participants were evaluated using a modified barium swallow test. Reasons that a participant did not perform the MBS, would be safety (the clinician did not feel that is was safe for the participant to undergo the MBS) or not indicated (an MBS was not clinically indicated at that time). Only completed MBS tests were evaluated.|||score on a scale||Full Range|Mean
2567612|NCT02564887|Primary|Tongue Pressure Generation (i.e. Tongue Strength) in Kilopascals (kPa) Using the IOPI Device|Change in tongue strength from baseline measurements; 2nd measurement collected post treatment (approximately 8 weeks from baseline)|8 weeks||||kPa||Full Range|Mean
2567613|NCT02564718|Primary|Anti-factor Xa Activity (Anti-Xa) Values at Day 8|The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.|10-16 hours post-dose on Day 8 (both bid and tid dosing)|PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.|||microgram per liter (mcg/L)||Standard Deviation|Mean
2567614|NCT02564718|Primary|Anti-factor Xa Activity (Anti-Xa) Values at Day 3|The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.|2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing)|PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.|||microgram per liter (mcg/L)||Standard Deviation|Mean
2567615|NCT02564718|Primary|Anti-factor Xa Activity (Anti-Xa) Values at Day 1|The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.|2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing)|PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.|||microgram per liter (mcg/L)||Standard Deviation|Mean
2567616|NCT02564718|Primary|Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 3|The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway and is sensitive for deficiencies of factors I, II, V, VIII, IX, X, XI and XII.|10-16 hours post-dose on Day 8 (baseline), 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing)|PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.|||seconds (sec)||Standard Deviation|Mean
2567617|NCT02564718|Primary|Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 1|The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway and is sensitive for deficiencies of factors I, II, V, VIII, IX, X, XI and XII.|10-16 hours post-dose on Day 8 (baseline), 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing)|PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.|||seconds (sec)||Standard Deviation|Mean
2567618|NCT02564718|Primary|Change From Baseline in Prothrombin Time at Day 3|Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.|10-16 hours post-dose on Day 8 (baseline), 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing)|PDS included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.|||seconds (sec)||Standard Deviation|Mean
2567619|NCT02564718|Primary|Change From Baseline in Prothrombin Time at Day 1|Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.|10-16 hours post-dose on Day 8 (baseline), 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing)|Pharmacodynamic (PD) analysis set (PDS) included all participants with at least 1 blood sample for clotting parameters in accordance with the PD sampling strategy were included in the PD analysis.|||seconds (sec)||Standard Deviation|Mean
2567620|NCT02564718|Primary|Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 8|Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated.|10 to 16 hours post-dose on Day 8 (bid dosing)|PKS included all participants with at least one PK sample in accordance with the PK sampling strategy.|||microgram per liter (mcg/L)||Geometric Coefficient of Variation|Geometric Mean
2567621|NCT02564718|Primary|Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 3|Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated.|2 to 8 hours post-dose (bid dosing) and 30 minutes to 3 hours post-dose; 7 to 8 hours post-dose on Day 3 (tid dosing)|PKS included all participants with at least one PK sample in accordance with the PK sampling strategy.|||microgram per liter (mcg/L)||Geometric Coefficient of Variation|Geometric Mean
2567635|NCT02564263|Secondary|Number of Participants Experiencing an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced ≥1 AE will be presented.|Through End-of-Trial Analysis data cutoff date of 31-Dec-2020 (up to approximately 5 years)||2021-12-31|12/2021||||
2567622|NCT02564718|Secondary|Number of Participants With Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging|Symptomatic recurrence of thromboembolism and asymptomatic deterioration was documented using the appropriate imaging test and confirmed by CIAC which was unaware of treatment assignment. Asymptomatic deterioration in thrombotic burden on repeat imaging, as assessed by the CIAC. Adjudication results were the basis for the final analyses.|From start of study drug administration until 30-day post study treatment period|Full analysis set (FAS) included all participants from whom informed consent was obtained and who contributed any data thereafter.|||count of participants|||Number
2567623|NCT02564718|Secondary|Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events|Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and •associated with a fall in hemoglobin of 2 gram/deciliter (g/dL) or more, •leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or •occurring in a critical site, example: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or •contributing to death. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with: •medical intervention, or •unscheduled contact (visit or telephone call) with a physician, or •cessation (temporary) of study treatment, or •discomfort for the child such as pain|From start of study drug administration until 30-day post study treatment period|Safety analysis set (SAF) included all participants who received at least one dose of rivaroxaban.|||count of participants|||Number
2567624|NCT02564718|Primary|Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1|Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated.|30 minutes to 1.5 hours post-dose; 2 to 4 hours post-dose (bid dosing) and 30 minutes to 3 hours post-dose; 7 to 8 hours post-dose on Day 1 (tid dosing)|Pharmacokinetic (PK) analysis set (PKS) included all participants with at least one PK sample in accordance with the PK sampling strategy.|||microgram per liter (mcg/L)||Geometric Coefficient of Variation|Geometric Mean
2567625|NCT02564497|Secondary|Half Life (T-HALF)||Day 1 to Day 71|All randomized, treated participants with evaluable PK data|||h||Standard Deviation|Mean
2567626|NCT02564497|Secondary|Volume of Distribution at Steady State (Vss)||Day 1 to Day 71|All randomized, treated participants with evaluable PK data|||L||Geometric Coefficient of Variation|Geometric Mean
2567627|NCT02564497|Secondary|Total Body Clearance (CLT)|CLT was the volume of belatacept cleared by the system, normalized by baseline body weight. Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA). CLT was measured in liters per hour.|Day 1 to Day 71|All randomized, treated participants with evaluable PK data|||L/h||Geometric Coefficient of Variation|Geometric Mean
2567628|NCT02564497|Secondary|Area Under the Serum Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC 0-T)|(AUC[0-T]) was derived from serum concentration versus time data and measured in nanogram hours per milliliter (ng.h/mL). Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA)|Day 1 to Day 71|All randomized, treated participants with evaluable PK data|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2567629|NCT02564497|Secondary|Time of Maximum Observed Serum Concentration (Tmax)|Tmax was derived from serum concentration versus time data. Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA). Tmax was measured in hours (h).|Day 1 to Day 71|All randomized, treated participants with evaluable PK data|||h||90% Confidence Interval|Median
2567630|NCT02564497|Primary|Maximum Observed Serum Concentration (Cmax) of Belatacept|Cmax was derived from serum concentration versus time data. Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA). Cmax was measured in nanograms per milliliter.|Day 1 to Day 71|All randomized, treated participants with evaluable PK data|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2567631|NCT02564497|Primary|Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (INF) of Belatacept.|(AUC[INF]) was derived from serum concentration versus time data and measured in nanogram hours per milliliter (ng*h/mL). Serum samples were analyzed for belatacept by a validated enzyme-linked immunosorbent assay (ELISA)|Day 1 to Day 71|All randomized, treated participants with evaluable PK data|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2567632|NCT02564432|Secondary|Time to Equilibrium of the Bacterial Community Types Over the Duration of the Study|Times required to reach stable Bacterial Community Types (CT) after the Stage 2 surgery. Dirichlet multinomial mixture modeling was used to examine the heterogeneity and optimal number of the community compositions within each sample site. Often, skin samples clustered optimally to a single community type. Five community types (CT1‐5) were identified: CT1 was defined by mixed communities of obligate anaerobes. CT2 was defined as those with median Shannon diversity index of ~4.5. CT3 was defined as the microbial community with the Shannon index of ~ 0.6 and dominated by Streptococcus. CT4 and CT5 were characterized by high relative abundances of Corynebacterium (median = 49%) and Staphylococcus (median = 34%), respectively. Patients, post-surgery, stabilized to one of CT1 - CT5 stomal microbiota.|On Day 3 after first surgery and day 3 prior to and days, 3, 14 and week 6 and months 3, 6, 9 and 12 after second surgery.|Ten unilateral transfemoral amputees with a percutaneous osseointegrated prosthetic docking system.|||Months||Standard Deviation|Mean
2567633|NCT02564432|Primary|Bacterial Community Types as Determined by Percentage RNA Sequence Reads|To compare, within each participant, the Bacterial Community Type dynamics over time, we used Loess regression to visualize local (temporal) trends in the data. Specifically, it takes the scatter-plot of values (relative abundances, diversity indices) and uses smoothing to identify local trends in the data. As percentage RNA sequence reads were the measure of central tendency, measure of dispersion of the data was not possible to calculate.|On Day 3 after first surgery and day 3 prior to and days, 3, 14 and week 6 and months 3, 6, 9 and 12 after second surgery.|Microbiota from implant stoma and ipsilateral thigh skin.|||Percentage RNA sequence reads|||Number
2567634|NCT02564263|Secondary|Number of Participants Discontinuing Study Treatment Due an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE will be presented.|Through End-of-Trial Analysis data cutoff date of 31-Dec-2020 (up to approximately 5 years)||2021-12-31|12/2021||||
2567636|NCT02564263|Secondary|Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)|ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants with a PD-L1 CPS ≥10 who experienced a CR or PR is presented.|Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)|The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
2567637|NCT02564263|Secondary|Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus|ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of participants with SCC of the esophagus who experienced a CR or PR is presented.|Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)|The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
2567638|NCT02564263|Secondary|Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)|PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by blinded independent central review per RECIST 1.1 is presented for participants with a PD-L1 CPS ≥10.|Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)|The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2567639|NCT02564263|Secondary|Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus|PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by blinded independent central review per RECIST 1.1 is presented for participants with SCC of the esophagus.|Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)|The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2567640|NCT02564263|Secondary|Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants|ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. The percentage of all participants who experienced a CR or PR is presented.|Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)|The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
2567641|NCT02564263|Secondary|Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants|PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by blinded independent central review per RECIST 1.1 in all participants is presented.|Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)|The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2567642|NCT02564263|Primary|Overall Survival (OS) in All Participants|OS was defined as the time from randomization to death due to any cause. Median OS in all participants is presented.|Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)|The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2567643|NCT02564263|Primary|Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)|OS was defined as the time from randomization to death due to any cause. Median OS in participants with a PD-L1 CPS ≥10 is presented.|Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)|The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2567644|NCT02564263|Primary|Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus|OS was defined as the time from randomization to death due to any cause. Median OS in participants with SCC of the esophagus is presented.|Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)|The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2567745|NCT02563990|Secondary|Postoperative Physical Therapy Milestone Achievement|The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).|postoperative week 4||||score on a scale||Full Range|Mean
2567645|NCT02564211|Secondary|Change From Baseline in HbA1c|Participants had HbA1c levels determined at baseline and at Week 52. HbA1c is reported as a percentage. A negative number reflects a decrease in percentage.|Baseline and Week 52|All participants who received at least 1 dose of treatment period study medication. had at least 1 measurement of the outcome variable (baseline or post-baseline) and had baseline data for those analyses that required baseline data.|||Percent||95% Confidence Interval|Mean
2567646|NCT02564211|Primary|Percentage of Participants Who Had Study Drug Discontinued Due to an AE|The percentage of participants who had study treatment stopped due to an AE regardless if they completed study.|Up to 52 weeks|All participants who received at least 1 dose of treatment period study medication.|||Percentage of Participants|||Number
2567647|NCT02564211|Primary|Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)|An AE was any unfavorable or unintended sign, symptom, or disease, and a causal relationship to the relevant investigational product is not considered. An AE could therefore be any unfavorable and unintended sign, including results from laboratory assessments, physical examination, electrocardiograms, and vital sign assessments. The percentage of participants that had AE was recorded.|Up to 54 weeks|All participants who received at least 1 dose of treatment period study medication.|||Percentage of participants|||Number
2567648|NCT02564120|Other Pre-specified|Number of Diagnostic Tests and Procedures During Follow-up|Number of diagnostic tests and procedures including biopsies, radiographic scans, laboratory tests, and procedures to assess cancer progression (active surveillance) or recurrence and work-up for treatment-related morbidity. Assessed through analysis of healthcare claims linked to cohort data.|4 years|We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info & either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy.|||tests or procedures||Standard Deviation|Mean
2567649|NCT02564120|Other Pre-specified|Number of Physician Visits During Follow-up|Number of physician and specialist visits during treatment, subsequent monitoring of recurrence and management of prostate cancer treatment-related morbidity. Assessed through analysis of healthcare claims linked to cohort data.|4 years|We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info & either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy.|||visits||Standard Deviation|Mean
2567650|NCT02564120|Secondary|5-year Mortality|Percentage of patients who died within 5 years of follow-up.|From date of diagnosis until date of death or end of follow-up up to 5 years|We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info & either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy.|||percentage of participants||95% Confidence Interval|Number
2567651|NCT02564120|Secondary|Decisional Regret|"Decisional regret was measured by a validated scale for prostate cancer. The five items of the decisional regret scale assess (on a Likert scale) a patient's feeling that he chose the wrong treatment, a wish to change the decision, or doubt about treatment value.~Answers are converted to a score from 0 (no regret) to 100 (maximum regret). Decisional regret provides an assessment of the overall decisional and treatment experience from a patient perspective."|4 years|We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info & either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy.|||percentage of participants||95% Confidence Interval|Number
2567652|NCT02564120|Secondary|Prostate Cancer Anxiety|Prostate cancer anxiety was measured by the validated Memorial Anxiety Scale for Prostate Cancer (MAX-PC), with 18 questions assessing anxiety related to prostate cancer (11 items, total score 0 to 33), PSA testing (3 items, total score 0 to 9), and fear of recurrence (4 items, total score 0 to 12). The subscale for prostate cancer anxiety asks the patient to report how frequently comments about prostate cancer were true for them during the past week (not at all, rarely, sometimes, or often). The subscale for PSA testing anxiety asks the patient to indicate how frequently situations have ever been true for them. The subscale for anxiety related to prostate cancer recurrence asks the patient to indicate how much they agree or disagree with statements about their own health during the past week. A higher score in each subscale indicates more anxiety.|4 years|We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info & either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy.|||score on a scale||95% Confidence Interval|Mean
2567653|NCT02564120|Primary|Prostate Cancer Recurrence|Percentage of patients who had a recurrence of prostate cancer during 5 years of follow-up.|From date of completion of treatment (radiation or surgery) until the date of recurrence or date of death from any cause, whichever came first, assessed up to 5 years.|We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info & either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy.|||percentage of participants||95% Confidence Interval|Number
2567654|NCT02564120|Primary|Overall Quality of Life|Short Form-12 (SF12) - Measures health-related quality of life. Consists of Likert response formats that assess overall health, mental health, vitality, social functioning, and whether ones health or pain limits their daily physical activities. The SF-12 also contains four categorical questions (yes or no) that assess limitations in functioning due to physical and emotional health. The SF-12 provides the Mental Component Summary score (MCS) and Physical Component Summary score (PCS), calculated using norm-based scoring, with the mean set at 50 and standard deviation 10. A lower score indicates lower QOL.|4 years|We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info & either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy.|||score on a scale||95% Confidence Interval|Mean
2567655|NCT02564120|Primary|Cancer-specific Quality of Life|"Prostate Cancer Symptom Indices (PCSI) - measures treatment-related morbidity and adverse effects and is comprised of 4 functional scales measuring Sexual Dysfunction, Bowel Problems, Urinary Incontinence, and Urinary Obstruction/Irritation. Four parallel distress indices measure distress from symptoms. In each index, patient answers are converted to a score from 0 (no symptom/distress) to 100 (maximum symptoms/distress). A 5-10 point difference in QOL is considered clinically meaningful."|4 years|We analyzed data from NC ProCESS, a population-based, prospective prostate cancer patient cohort. The analytic cohort were men who completed baseline survey info & either underwent active surveillance or received initial treatment with stereotactic body radiation therapy, radical prostatectomy, external beam radiation therapy, or brachytherapy.|||score on a scale||95% Confidence Interval|Mean
2567656|NCT02564055|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|"Single measurements of 12-lead ECGs were obtained at Baseline , Week 1, Week 12, Week 14 (follow up 1), EW and at any time post-screen using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc). Baseline was defined as the latest assessment prior to the first dose. For multiple ECGs at one visit, or Any visit post-screen, a participant was categorized as Abnormal if >=1 assessment was abnormal. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles)."|Baseline, Week 1, 12, 14, EW ( up to Week 14), post-screen|Safety population|||Participants|||Number
2567657|NCT02564055|Secondary|Number of Participants With Vital Signs of Potential Clinical Importance|Blood samples were collected from participants for evaluation of vital signs by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included SBP, DBP and pulse rate. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Baseline, Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Participants|||Number
2567658|NCT02564055|Secondary|Change From Baseline in Temperature|Temperature were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 1, 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Degree Celsius||Standard Deviation|Mean
2567659|NCT02564055|Secondary|Change From Baseline in Pulse Rate|Pulse rate were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 1, 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Beats per minute (bpm)||Standard Deviation|Mean
2567660|NCT02564055|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 1, 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2567661|NCT02564055|Secondary|Number of Participants With Immunoglobulin Data Outside the Reference Range|Blood samples were collected from participants for evaluation of immunoglobulin data outside the reference range at Baseline, Week 4, Week 8, Week 12 and any visit post-screen. The immunoglobulin parameters included IgA, IgG and Ig M. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Baseline, Week, 4, 8, 12, post-screen (up to Week 16)|Safety population|||Participants|||Number
2567662|NCT02564055|Secondary|Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels|Blood samples were collected to evaluate change from Baseline in IgA, IgG, IM values at Baseline throughout the 12 weeks of study treatment. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week, 4, 8 and 12|Safety population|||G/L||Standard Deviation|Mean
2567663|NCT02564055|Secondary|Number of Participants With Immunopheotyping Data Outside the Reference Range|Blood samples were collected from participants for evaluation of immunophenotyping parameters by Potential Clinical Importance Criteria at Baseline, Week 4, Week 8, Week 12 nd any visit post-screen. The immunophenotyping parameters included CD 19, CD3, CD3+CD8+, CD3+CD4+, CD16+CD56+, CD3+CD4+CD25+CD127, CD3+CD4+foxP3+CD25+CD127 and T and NK lympho. CD3, CD3+CD8+ and CD3+CD4+ were also evaluated by using treg flow cyto. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Baseline, Week, 4, 8, 12 and post-screen (up to Week 16)|Safety population|||Participants|||Number
2567664|NCT02564055|Secondary|Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels|Blood samples were collected to evaluate change from Baseline in total T lympho, B lympho, T and B NK cells and (Foxp3) values at Baseline throughout the 12 weeks of study treatment. The immunophenotyping parameters included cluster of differentiation (CD)19, CD3, CD3+CD8+, CD3+CD4+, CD16+CD56+, CD3+CD4+CD25+CD127, CD3+CD4+foxP3+CD25+CD127 and T and NK lympho. CD3, CD3+CD8+ and CD3+CD4+ were also evaluated by using treg flow cytometry (cyto). Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week, 4, 8 and 12|Safety population|||GI/L||Standard Deviation|Mean
2567746|NCT02563990|Secondary|Postoperative Physical Therapy Milestone Achievement|The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).|postoperative week 3||||score on a scale||Full Range|Mean
2567665|NCT02564055|Secondary|Number of Participants With Hematology Data of Potential Clinical Importance|Blood samples were collected from participants for evaluation of hematology parameters by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included hematocrit, hemoglobin, lymphocytes, neutrophils, platelet and leukocytes. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Baseline, Week 2, 4, 8, 12, 14, early withdrawal, and post screen (up to Week 16)|Safety Population|||Participants|||Number
2567666|NCT02564055|Secondary|Change From Baseline in Erythrocyte Count|Blood samples were collected to evaluate change from Baseline in erythrocytes and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Weeks 2, 4, 8, 12, 14, EW (week up to 14)|Safety Population|||Tetra cells per liter (TI/L)||Standard Deviation|Mean
2567667|NCT02564055|Secondary|Change From Baseline in Mean Corpuscle Volume (MCV)|Blood samples were collected to evaluate change from Baseline in MCV and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Femtoliter (fL)||Standard Deviation|Mean
2567668|NCT02564055|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH)|Blood samples were collected to evaluate change from Baseline in MCH and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Picogram (Pg)||Standard Deviation|Mean
2567669|NCT02564055|Secondary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)|Blood samples were collected to evaluate change from Baseline in hemoglobin and MCHC and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||G/L||Standard Deviation|Mean
2567670|NCT02564055|Secondary|Change From Baseline in Hematocrit Levels|Blood samples were collected to evaluate change from Baseline in hematocrit and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
2567671|NCT02564055|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count|Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet and leukocytes and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Giga cells per liter (GI/L)||Standard Deviation|Mean
2567672|NCT02564055|Secondary|Number of Participants With Chemistry Data of Potential Clinical Importance|Blood samples were collected from participants for evaluation of clinical chemistry parameters by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included alk.phosph., ALT, AST, bilirubin, calcium, CO2, creatinine, glucose and potassium. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Participants|||Number
2567673|NCT02564055|Secondary|Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN)|Blood samples were collected to evaluate change from Baseline in calcium, chloride, CO2, glucose, potassium, sodium and BUN values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2567674|NCT02564055|Secondary|Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate|Blood samples were collected to evaluate change from Baseline in direct and total bilirubin, creatinine and urate values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2567675|NCT02564055|Secondary|Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT)|Blood samples were collected to evaluate change from Baseline in Alk.phosph., ALT, AST and GGT values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||International unit per liter (IU/L)||Standard Deviation|Mean
2567676|NCT02564055|Secondary|Change From Baseline in Albumin and Total Protein|Blood samples were collected to evaluate change from Baseline in albumin and total protein values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.|Week 1, 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Gram per Liter (G/L)||Standard Deviation|Mean
2567677|NCT02564055|Secondary|Number of Participants With Reported Tolerability Score of 0 to 4 Over Time|Participants were asked to use a 5-point tolerability scale from 0 (none) to 4 (severe) to assess the presence and degree of burning/stinging and itching at the application sites that has generally been experienced following application of the study treatment. The score represented an 'average' across all application sites. A score of 3 or 4 was reported as an AE. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Week 1, 2, 4, 8, 12, 14, EW (up to Week 14)|Safety Population|||Participants|||Number
2567678|NCT02564055|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. Treatment emergent AEs (TEAE) is defined as AE occurred on or after study treatment start date and on or before last visit. Number of participants with AEs and serious TEAEs were presented. The analysis was performed on Safety population which comprised of all participants who receive at least one dose of study treatment.|Weeks 1, 2, 4, 8, 12, 14, EW (up to week 14)|Safety Population|||Participants|||Number
2567679|NCT02564055|Secondary|Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit|The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants who have an IGA score of clear or almost clear and a minimum 2 grade improvement from Baseline to each study visit in IGA score was presented. The statistical analysis was performed using a repeated measures factorial logistic regression model with covariates for dose, frequency of administration, and study day as well as a dose by frequency interaction term. The analysis was performed on ITT Population which comprised of all randomized participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category title).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to week 16)|ITT Population|||Percentage of participants|||Number
2567680|NCT02564055|Secondary|Mean Change From Baseline in IGA Score|The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. Score ranges from 0 (clear) to 4 (severe). Higher values represent a severe disease. Mean change from Baseline in IGA score was presented using mean and SD at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit. Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Scores on a scale||Standard Deviation|Mean
2567681|NCT02564055|Secondary|Mean Change From Baseline in Body Surface Area (Percent BSA)|The extent of BSA affected by AD is a general indicator of disease severity and the assessment of BSA with AD was performed separately for four body surface regions: the head (h), the upper extremities (u), the trunk (t) and the lower extremities (l), corresponding to 10, 20, 30, and 40 percent of the total body area, respectively. Mean change from Baseline in percent BSA was presented using mean and SD at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit. Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Percentage of surface area||Standard Deviation|Mean
2567682|NCT02564055|Secondary|Mean Percent Change From Baseline in Individual Signs of TSS|The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) and TSS (maximum score 15) was calculated based on these signs. Mean percent change from Baseline in individual signs of TSS was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. NA indicates that data were not available. If the participant had more than 3 missing days during the week, then the weekly average was not calculated and treated as missing data and excluded from the analysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Percentage Change||Standard Deviation|Mean
2567683|NCT02564055|Secondary|Mean Change From Baseline in Individual Signs of TSS|The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) and TSS (maximum score 15) was calculated based on these signs. Mean change from Baseline in individual signs of TSS was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. If the participant had more than 3 missing days during the week, then the weekly average was not calculated and treated as missing data and excluded from the analysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Scores on a scale||Standard Deviation|Mean
2567684|NCT02564055|Secondary|Mean Percent Change From Baseline in TSS|A target lesion of at least 3 cm^2 was selected at Baseline. The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) , with higher values indicating greater severity of symptoms. TSS (maximum score 15) was calculated based on these signs. Mean percent change from Baseline in TSS at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Percentage Change||Standard Deviation|Mean
2567685|NCT02564055|Secondary|Mean Change From Baseline in Total Severity Score (TSS)|A target lesion of at least 3 centimeter square (cm^2) was selected at Baseline. The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe), with higher values indicating greater severity of symptoms. TSS (maximum score 15) was calculated based on these signs. Mean change from Baseline in TSS at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Scores on a scale||Standard Deviation|Mean
2567686|NCT02564055|Secondary|Percentage of Participants With >=75 Percent Improvement From Baseline in EASI|The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Percentage of participants with >=75 percent improvement in EASI score from Baseline to Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW were presented and statistical analysis was performed using a repeated measures factorial logistic regression model. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Percentage of participants|||Number
2567687|NCT02564055|Secondary|Percentage of Participants With >=50 Percent Improvement From Baseline in EASI|The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Percentage of participants with >=50 percent improvement in EASI score from Baseline to Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW were presented and statistical analysis was performed using a repeated measures factorial logistic regression model. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Percentage of participants|||Number
2567688|NCT02564055|Secondary|Percentage of Participants With an IGA Score of 0 or 1 at Each Visit|The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants with an IGA score of 0 or 1 at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Percentage of participants|||Number
2567689|NCT02564055|Secondary|Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit|The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants with a minimum 2-grade improvement in IGA score from Baseline at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and early withdrawal (EW) visit was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Percentage of participants|||Number
2567690|NCT02564055|Secondary|Mean Percent Change From Baseline in EASI Score|The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale (0 [absent] to 3 [severe]) for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Body area involvement ranged from 0 (0%) to 6 (90-100%). Total EASI score was calculated as a sum of scores of all 4 specified body region. Range for EASI total score is 0 (absent) to 72 (severe). Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean percent change from Baseline was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Percentage Change||Standard Deviation|Mean
2567700|NCT02564042|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2567691|NCT02564055|Secondary|Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score|The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale (0 [absent] to 3 [severe]) for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Body area involvement ranged from 0 (0%) to 6 (90-100%). Total EASI score was calculated as a sum of scores of all 4 specified body region. Range for EASI total score is 0 (absent) to 72 (severe). Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean change from Baseline was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)|ITT Population|||Scores on a scale||Standard Deviation|Mean
2567692|NCT02564055|Secondary|Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit|NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Percentage of participants who achieved a minimum 3-point improvement in itch/pruritus (NRS) from Baseline to each study visit were measured. Baseline was defined as the latest assessment prior to first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Week 1, 2, 4, 8, 12, 14, 16, early withdrawal (EW) (up to Week 16)|ITT Population|||Percentage of Participants|||Number
2567693|NCT02564055|Secondary|Mean Percent Change From Baseline in Weekly Average of Daily Itch/Pruritus NRS Score|NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Mean percent change in weekly average of daily itch/pruritus based on the NRS was presented using mean and SD from Baseline to Week 12. Baseline was defined as the latest assessment prior to first dose and Change from Baseline was defined as post-dose weekly average value minus Baseline value.|Baseline and up to Week 12|ITT Population|||Percentage Change||Standard Deviation|Mean
2567694|NCT02564055|Secondary|Mean Change From Baseline in Weekly Average of Daily Itch/Pruritus (Numeric Rating Scale [NRS]) Score|NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Mean change from Baseline to Week 12 in weekly average of daily itch/pruritus based on the NRS was presented using mean and standard deviation (SD). Baseline was defined as the latest assessment prior to first dose and Change from Baseline was defined as post-dose weekly average value minus Baseline value.|Baseline and up to Week 12|ITT Population|||Scores on a scale||Standard Deviation|Mean
2567695|NCT02564055|Primary|Percentage of Participants Who Have an Investigator Global Assessment (IGA) Score of Clear or Almost Clear (0 or 1) at Week 12 and a Minimum 2 Grade Improvement in IGA Score From Baseline to Week 12 for Intent to Treat (ITT) Population|The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. The percentage of participants who have an IGA score of clear or almost clear at Week 12 and a minimum 2 grade improvement from Baseline to Week 12 in IGA score was presented. . The analysis was performed on ITT Population which comprised of all randomized participants.|Baseline and up to Week 12|ITT Population. Only those participants with data available at specified data points were analyzed.|||Percentage of participant|||Number
2567696|NCT02564042|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|"Single 12-lead ECGs were obtained over a brief recording period at each specified time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. For multiple ECGs at one visit, or Any time post-screen, a participant is categorized as Abnormal if >=1 assessment is abnormal. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title)."|Up to Week 14|Safety Population|||Participants|||Number
2567697|NCT02564042|Secondary|Number of Participants With Vital Signs of Clinical Importance|The vital signs including SBP, DBP and pulse rate were measured from Baseline throughout the study. The number of participants with clinically significant abnormal vital signs were presented. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Week 14|Safety Population|||Participants|||Number
2567698|NCT02564042|Secondary|Change From Baseline in Temperature|Temperature was measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||degree Celsius||Standard Deviation|Mean
2567699|NCT02564042|Secondary|Change From Baseline in Pulse Rate|Pulse rate was measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||beats per minute||Standard Deviation|Mean
2567741|NCT02564016|Secondary|Count of Participants Who Experienced Epidural Reactivation Failure||one year||||Participants|||Count of Participants
2567701|NCT02564042|Secondary|Change From Baseline in Immunophenotype Data|Blood samples were collected for the evaluation of change from Baseline in immunophenotype levels including CD19, CD3, CD3TFLC, CD3+CD8+, CD3+CD8+ TFLC, CD3+CD4+, CD3+CD4+ TFLC, CD16+CD56+, CD3+CD4+CD25+CD127 flow cytometry (CD3+CD4+CD25+CD127), CD3+CD4+foxP3+CD25+CD127 flow cytometry (CD3+CD4+fP3+CD25+CD127) and T-B cell NKL. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 12|Safety Population|||GI/L||Standard Deviation|Mean
2567702|NCT02564042|Secondary|Number of Participants With Immunophenotyping Data Outside the Reference Range|Blood samples were collected for the evaluation of change in levels of cluster of differentiation (CD)19, CD3, CD3 Treg flow cytometry (CD3TFLC), CD3+CD8+, CD3+CD8+ TFLC, CD3+CD4+, CD3+CD4+ TFLC, CD16+CD56+, CD3+CD4+CD25+CD127 flow cytometry (CD3+CD4+CD25+CD127), CD3+CD4+foxP3+CD25+CD127 flow cytometry (CD3+CD4+fP3+CD25+CD127) and T Cell B Cell Natural Killer Lymphocytes flow cytometry (T-B cell NKL). Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Week 12|Safety Population|||Participants|||Number
2567703|NCT02564042|Secondary|Number of Participants With Ig Data Outside the Reference Range|Blood samples were collected for the evaluation of change in Ig levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Week 12|Safety Population|||Participants|||Number
2567704|NCT02564042|Secondary|Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels|Blood samples were collected for the evaluation of change in IgA, IgG and IgM levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 12|Safety Population|||g/L||Standard Deviation|Mean
2567705|NCT02564042|Secondary|Number of Participants With Hematology Data of Clinical Importance|Blood samples were collected for the evaluation of hematology parameters including hematocrit, Hgb, lymphocytes, neutrophils and platelets. The number of participants with clinically significant abnormal values of the mentioned hematology parameters was presented. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Week 14|Safety Population|||Participants|||Number
2567706|NCT02564042|Secondary|Number of Participants With Chemistry Data of Potential Clinical Importance|Blood samples were collected for the evaluation of clinical chemistry parameters including alk phos, ALT, AST, bil, calcium, CO2, creatinine, glucose and potassium. The number of participants with chemistry data of potential clinical importance for the mentioned parameters was presented. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Week 14|Safety Population|||Participants|||Number
2567707|NCT02564042|Secondary|Change From Baseline in Erythrocyte Count|Blood samples were collected for the evaluation of change in erythrocyte count from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||Tetra unit/L (TI/L)||Standard Deviation|Mean
2567708|NCT02564042|Secondary|Change From Baseline in Erythrocyte Mean Corpuscular Volume|Blood samples were collected for the evaluation of change in erythrocyte mean corpuscular volume from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||Femtoliter (fL)||Standard Deviation|Mean
2567709|NCT02564042|Secondary|Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level|Blood samples were collected for the evaluation of change in erythrocyte mean corpuscular hemoglobin level from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||Picogram (pg)||Standard Deviation|Mean
2567710|NCT02564042|Secondary|Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC)|Blood samples were collected for the evaluation of change in Hgb levels and MCHC from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||G/L||Standard Deviation|Mean
2567711|NCT02564042|Secondary|Change From Baseline in Hematocrit Levels|Blood samples were collected for the evaluation of change in hematocrit levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
2567742|NCT02564016|Secondary|Count of Participants Whose BMI Affected the Reactivation Rate of Labor Epidurals for Postpartum Tubal Ligation Surgery Following Vaginal Delivery.||one year||||Participants|||Count of Participants
2567712|NCT02564042|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count|Blood samples were collected for the evaluation of change in levels of basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocyte count from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||Giga unit/liter (GI/L)||Standard Deviation|Mean
2567713|NCT02564042|Secondary|Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels|Blood samples were collected for the evaluation of change in levels of calcium, chloride, CO2, glucose, potassium, sodium, and urea from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||millimoles (mmol)/L||Standard Deviation|Mean
2567714|NCT02564042|Secondary|Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.|Blood samples were collected for the evaluation of change in levels of direct bil, bil, creatinine and urate from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||micromoles (µmol)/L||Standard Deviation|Mean
2567715|NCT02564042|Secondary|Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.|Blood samples were collected for the evaluation of change in levels of alk phos, ALT, AST and GGT from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||International Units (IU)/L||Standard Deviation|Mean
2567716|NCT02564042|Secondary|Change From Baseline in Albumin and Protein Level|Blood samples were collected for the evaluation of change in albumin and protein levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 14|Safety Population|||grams/liter (g/L)||Standard Deviation|Mean
2567717|NCT02564042|Secondary|Number of Participants With Reported Local Tolerability Scores|The assessment of the presence and degree of burning/stinging and itching at the application site following application of the study treatment was done at each specified study visit using a 5 point tolerability scale. The scores ranged from 0 to 4 where 0=None and 4=Strong/Severe. The score represented an average across all application sites. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Week 14|Safety Population|||Participants|||Number
2567718|NCT02564042|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs|An AE is defined as any untoward medical occurrence in a participant under clinical investigation, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. A TEAE is defined as an AE which occurred on or after study treatment start date and on or before the last visit. Number of participants with AEs and SAEs were presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.|Up to Week 16|Safety Population|||Participants|||Number
2567719|NCT02564042|Secondary|Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit|The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of responders that is, participants who achieved a PGA score of 0 or 1 and a minimum 2-grade improvement from baseline were summarized. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 16|mITT Population|||Percentage of participants|||Number
2567720|NCT02564042|Secondary|Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit|The participant reported itch severity was obtained from the response of the participants to the itch NRS item in the psoriasis symptom diary (PSD). PSD was developed to assess daily self-reports of psoriasis symptoms and the functional impact related to the underlying pathophysiology of the disease. The participants answered questions related to the severity and impact of the signs and symptoms daily using a 11 point NRS with scores ranging from 0 (absent) to 10 (worst imaginable). Mean change in itch/pruritis NRS from Baseline to each study visit was presented. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the post dose weekly average value minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 16|mITT Population|||Scores on a scale||Standard Deviation|Mean
2568201|NCT02556918|Secondary|Amount of Subcutaneous (SC) Insulin Taken in Intensive Care Unit (ICU)|Total amount of SC insulin taken by ICU patients during recovery period.|2 days (average time of discharge from ICU)||||units||Standard Deviation|Mean
2567721|NCT02564042|Secondary|Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit|A single target lesion of at least 3 centimeter (cm) x 3 cm was selected at Baseline. For the selected lesion, the severity of erythema, scaling and plaque thickness (induration) was assessed by the investigator on a 5-point scale ranging from 0=none to 4=severe. The mean change in individual grading scores from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 16|mITT Population|||Scores on a scale||Standard Deviation|Mean
2567722|NCT02564042|Secondary|Mean Change in PGA Score From Baseline to Each Study Visit|The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The mean change in PGA scores from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 16|mITT Population|||Scores on a scale||Standard Deviation|Mean
2567723|NCT02564042|Secondary|PGA Scores at Each Study Visit|The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The mean of PGA scores at each study visit was summarized. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Week 16|mITT Population|||Scores on a scale||Standard Deviation|Mean
2567724|NCT02564042|Secondary|Mean Change in PASI Score From Baseline to Each Study Visit|The PASI is a standard clinical tool for assessing the severity of psoriasis based on severity of erythema, thickness and scale, as well as the extent of BSA affected with psoriasis. The 3 clinical signs were graded on a 5 point scale (0=None to 4=Severe) and the percent of BSA affected is scored on a 7-point scale (0=0% involvement to 6=90-100%) for each of 4 specified body regions (head, upper extremities, trunk and lower extremities). The individual scores were multiplied by a weighted factor for each body region. The sum of these scores gave the overall PASI score. PASI score ranged from 0=no psoriasis to 72=worse psoriasis. The mean change in PASI score from Baseline was summarized for each study visit. Baseline was the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 16|mITT Population|||Scores on a scale||Standard Deviation|Mean
2567725|NCT02564042|Secondary|Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit|The extent of BSA affected by psoriasis is a general indicator of disease severity and was measured throughout the study. The extent of BSA to which study treatment was applied was also recorded. For the purpose of approximate clinical estimation, the total palmar surface of the palm plus 5 digits was assumed to be approximately equivalent to 1 percent BSA. Assessment of BSA affected with psoriasis was performed separately for four body surface regions: the head, the upper extremities, the trunk and the lower extremities, corresponding to 10, 20, 30 and 40 percent of the total body area, respectively. The mean change in percent BSA affected from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 16|mITT Population|||Percentage of BSA||Standard Deviation|Mean
2567726|NCT02564042|Secondary|Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit|The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of participants who achieved a PGA score of 0 or 1 from Baseline at each study visit was summarized. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Week 16|mITT Population|||Percentage of participants|||Number
2567727|NCT02564042|Secondary|Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit|The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of participants who achieved a minimum 2-grade improvement from Baseline for each study visit were summarized. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 16|mITT Population|||Percentage of participants|||Number
2567743|NCT02564016|Primary|Number of Participants With Successful Epidural Reactivation|The goal of this study is to evaluate the effect of continuous postpartum epidural saline infusion on the reactivation of labor epidurals for postpartum tubal ligation surgery following vaginal delivery.|one year||||participants|||Number
2567744|NCT02563990|Secondary|Opioid Administration|Intraoperative and immediate postoperative opioid administration. Calculated as morphine milliequivalent (in milligrams).|day 1||||milligrams||Standard Error|Mean
2567728|NCT02564042|Secondary|Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit|The PASI is a standard clinical tool for assessing the severity of psoriasis based on severity of erythema, thickness and scale, as well as the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs were graded on a 5 point scale (0 to 4) and the % BSA affected was scored on a 7-point scale (0 to 6) for each of the 4 specified body regions (head, upper extremities, trunk and lower extremities). The individual scores were multiplied by a weighted factor for each body region. The sum of these scores gave the overall PASI score. Higher scores indicated more severe disease. The percentage of participants with >=75% improvement in PASI from Baseline were summarized. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Week 16|mITT Population|||Percentage of participants|||Number
2567729|NCT02564042|Primary|Percentage of Participants Who Have a Physician Global Assessment (PGA) Score of 0 or 1 at Week 12 and a Minimum 2-grade Improvement in PGA Score From Baseline to Week 12|The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of responders that is, participants who achieved a PGA score of 0 or 1 and a minimum 2-grade improvement from Baseline were summarized. Baseline was defined as the latest assessment prior to the first dose. The analysis was performed on modified intent-to-treat (mITT) Population which comprised of all randomized participants except those enrolled at center ID 220008.|Baseline and up to Week 12|mITT Population|||Percentage of participants|||Number
2567730|NCT02564029|Secondary|Number of Participants With Treatment-emergent Adverse Events (AEs)|The all causalities treatment-emergent AEs by System Organ Class and Preferred Term in >5% of subjects. AEs included serious AEs and non-serious AEs.|19 weeks|The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period.|||Participants|||Number
2567731|NCT02564029|Secondary|Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings||17 weeks|The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period.|||Participants|||Number
2567732|NCT02564029|Secondary|Number of Participants With Clinically Significant Change From Baseline in Blood Pressure and Pulse Rate||17 weeks|The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period.|||Participants|||Number
2567733|NCT02564029|Secondary|Number of Participants With Clinically Significant Laboratory Test Abnormalities|Safety laboratory tests included hematological, clinical chemistry (serum) and urinalysis safety tests.|17 weeks|The Safety Analysis Set included all participants who received at least 1 dose of investigational product in the respective study treatment period.|||Participants|||Number
2567734|NCT02564029|Secondary|Plasma Concentration of Lorazepam||1, 2, 3, 4 and 6 hours post-dose|All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.|||ng/mL||Standard Deviation|Mean
2567735|NCT02564029|Secondary|Time for Cmax (Tmax) of PF-06372865||1, 2, 4 and 6 hours post-dose|All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.|||hour||Full Range|Median
2567736|NCT02564029|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06372865||Pre-dose, 1, 2, 3, 4 and 6 hours post-dose|All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2567737|NCT02564029|Secondary|Maximum Plasma Concentration (Cmax) of PF-06372865||1, 2, 4 and 6 hours post-dose|All enrolled participants treated who had at least 1 measureable concentration in the respective study dose period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2567738|NCT02564029|Secondary|The Percentage of Participants With Complete Suppression, Partial Response, and no Response to Intermittent Photic Stimulation (IPS)|Complete suppression: SPR = 0 in all three eye conditions at the same time point. Partial response: A reduction in SPR of at least 3 units from baseline for at least 3 time points, and no time points with at least 3 units of increase, in the most sensitive eye condition; without meeting the complete suppression definition. No response: Did not meet complete suppression or partial response definitions.|Pre-dose, 1, 2, 4 and 6 hours post-dose|Full analysis set: all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 primary efficacy measurement in at least 1 study treatment period.|||Percentage of participants|||Number
2567739|NCT02564029|Secondary|The SPR in the Eye Closure, Eyes Closed, and Eyes Open Condition|The SPR was defined as the number of frequency steps between and including the lower and upper bound at which a generalized electroencephalogram (EEG) epileptiform activity had occurred, whereby subjects were exposed to 14 different frequencies ranging from 2 to 60 flashes per second. The SPR is then an integer score that ranges from 0 to 14 with lower scores representing better outcomes. The outcome measure was based on the average Least Squares Mean (LSmean) effect over the first 6 hours postdose.|Pre-dose, 1, 2, 4 and 6 hours post-dose|Full analysis set: all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 primary efficacy measurement in at least 1 study treatment period.|||Units on a scale||Standard Error|Least Squares Mean
2567740|NCT02564029|Primary|The Standardized Photosensitivity Range (SPR) in the Subject's Most Sensitive Eye Condition|The SPR was defined as the number of frequency steps between and including the lower and upper bound at which a generalized electroencephalogram (EEG) epileptiform activity had occurred, whereby subjects were exposed to 14 different frequencies ranging from 2 to 60 flashes per second. The SPR is then an integer score that ranges from 0 to 14 with lower scores representing better outcomes. The primary outcome measure was based on the average Least Squares Mean (LSmean) effect over the first 6 hours postdose.|Pre-dose, 1, 2, 4 and 6 hours post-dose|Full analysis set: all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 primary efficacy measurement in at least 1 study treatment period.|||Units on a scale||Standard Error|Least Squares Mean
2567747|NCT02563990|Secondary|Postoperative Physical Therapy Milestone Achievement|The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).|postoperative week 2||||score on a scale||Full Range|Mean
2567748|NCT02563990|Secondary|Postoperative Physical Therapy Milestone Achievement|The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).|postoperative week 1||||score on a scale||Full Range|Mean
2567749|NCT02563990|Secondary|Postoperative Pain Scores (Numeric Rating Scale, 0-10)|Patients will rate their pain after surgery on a scale from 0-10, with 0 being no pain, and 10 being the worst pain of their life.|postoperative on day 1||||score on a scale||Inter-Quartile Range|Median
2567750|NCT02563990|Secondary|Number of Events of Sciatic Nerve Block 30 Minutes After Block Placement|Sensory testing will use a pinprick method in the femoral (anterior thigh), saphenous (medial calf proximal to the medial malleolus, top of the patella) and sciatic (posterolateral calf, plantar surface of the foot) nerve distributions; if patients are unable to feel the stimulus in the sciatic nerve distribution, then an outcome of a sciatic nerve block will be recorded.|post-procedure and postoperative on day 1||||Events|||Number
2567751|NCT02563990|Secondary|Number of Events of Femoral Nerve Block 30 Minutes After Block Placement|Sensory testing will use a pinprick method in the femoral (anterior thigh), saphenous (medial calf proximal to the medial malleolus, top of the patella) and sciatic (posterolateral calf, plantar surface of the foot) nerve distributions; if patients are unable to feel the stimulus in the femoral nerve distribution, then an outcome of a femoral nerve block will be recorded.|post-procedure and postoperative on day 1||||Events|||Number
2567752|NCT02563990|Primary|Spread of Injectate|Our primary endpoint is the spread of injectate, defined as the distance between the uppermost and lowermost limits of spread of local anesthetic as assessed by ultrasound.|Immediate post-procedure on day 1||||cm||Full Range|Mean
2567753|NCT02563899|Secondary|Percentage of Participants With 2-point Decrease From Baseline to Day 15 in HDSS Score|HDSS is a 4-point scale which used to assess the impact of disease. The scores are define as, 1- My (underarm) sweating is never noticeable and never interferes with my daily Activities; 2- My (underarm) sweating is tolerable but sometimes interferes with my daily activities; 3- My (underarm) sweating is barely tolerable and frequently interferes with my daily activities; 4- My (underarm) sweating is intolerable and always interferes with my daily activities. Average score of both left and right underarms were used for analysis. The possible average score range from 1 (minimum) to 4 (maximum). Increase in score on scale represents worsening. Assessments conducted at Day 1, pre-dose time point (average pre-dose measurements for both left and right underarm measurements) were considered as Baseline values. Change from baseline was calculated as Day 15 Visit Value minus Baseline values. Percentage of participants with 2-point decrease from Baseline to Day 15 in HDSS score were reported.|Baseline (Pre-dose, Day 1) and Day 15|Full Analysis population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
2567754|NCT02563899|Secondary|Change in Hyperhidrosis Disease Severity Scale (HDSS) at Day 15|The HDSS is a 4-point scale which used to assess the impact of disease. The scores were define as, 1- My (underarm) sweating is never noticeable and never interferes with my daily Activities; 2- My (underarm) sweating is tolerable but sometimes interferes with my daily activities; 3- My (underarm) sweating is barely tolerable and frequently interferes with my daily activities; 4- My (underarm) sweating is intolerable and always interferes with my daily activities. Average score of both left and right underarms were used for analysis. The possible average score range from 1 (minimum) to 4 (maximum). The reduction in score on the scale presents betterment and increase in the score represents worsening. Assessments conducted at Day 1, pre-dose time point (average pre-dose measurements for both left and right underarm measurements) were considered as Baseline values. Change from baseline was calculated as Day 15 Visit Value minus Baseline values.|Baseline (Pre-dose, Day 1) and Day 15|Full Analysis population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Score on Scale||Standard Error|Mean
2567755|NCT02563899|Secondary|Percentage of Participants With Cut-points for Percent Change From Baseline in Sweat Production at Day 15|Amount of sweat produced was determined by gravimetry analysis for axilla. Filter paper in a sealed container was weighed. After drying the axillary surface, the filter paper was removed from the container and applied to the axilla. The paper was covered with plastic wrap and tape around the edges with paper tape. The filter paper was left in contact with the axilla for a period of 5 minutes as measured by a stopwatch. The filter paper was then replaced in the sealed container and re-weighed. Rate of sweat production was calculated in milligrams/minute. Assessments conducted at Day 1, Pre-dose time point (average pre-dose measurements for both left and right measurements) were considered as Baseline values. Percent change from Baseline= 100 x ( Day 15 value - Baseline value) / Baseline value. The percentage of participants with cutpoints (-30%, -50, -75%) for percent change from Baseline in sweat production were presented.|Baseline (Pre-dose, Day 1) and Day 15|Full Analysis population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
2567756|NCT02563899|Secondary|Change From Baseline in Amount of Sweat Produced at Day 15|Amount of sweat produced was determined by gravimetry analysis for axilla. Filter paper in a sealed container was weighed. After drying the axillary surface, the filter paper was removed from the container and applied to the axilla. The paper was covered with plastic wrap and tape around the edges with paper tape. The filter paper was left in contact with the axilla for a period of 5 minutes as measured by a stopwatch. The filter paper was then replaced in the sealed container and re-weighed. Rate of sweat production was calculated in milligrams/minute (mg/min). Participants remained at rest for 20-30 minute before the measurements in order to reduce external interference. Measurements were carried out in a climate-controlled environment (21-24°C). Assessments conducted at Day 1, Pre-dose time point (average pre-dose measurements for both left and right measurements) were considered as Baseline values. Change from baseline was calculated as Day 15 value minus Baseline value.|Baseline (Pre-dose, Day 1) and Day 15|Full Analysis population comprised of participants receiving study medication and having at least 1 post baseline visit. Only those participants available at the specified time points were analyzed.|||mg/ min||Standard Deviation|Mean
2567757|NCT02563899|Primary|Number of Participants With Local Tolerability Assessment Score Over 28 Days|The investigator or designated evaluator assessed skin tolerability at each visit using the 5-point tolerability scale. Tolerability of the topical application was assessed and scored as, 0- none (no evidence of local intolerance), 1-mild (minimal erythema and/or edema, slight glazed appearance), 2-moderate (definite erythema and/or edema with peeling and/or cracking but needs no adaptation of posology), 3-severe (erythema, edema glazing with fissures, few vesicles or papules), 4- very severe (strong reaction spreading beyond the treated area, bullous reaction, erosions).|Days 1, 2, 4, 5, 6, 7, 8, 9, 10, 13, 14, 15, 16, and 23|Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093).|||Participants|||Count of Participants
2567758|NCT02563899|Primary|Number of Participants With Abnormal Values of Potential Clinical for Vital Signs|The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (<85 and >160 millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.|Up to 28 days|Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093).|||Participants|||Count of Participants
2567759|NCT02563899|Primary|Number of Participants With Urinalysis Abnormalities of Potential Clinical Importance at Any Time on Treatment|The urinalysis parameters analyzed were specific gravity, pH, glucose, protein, blood and ketones by dipstick, microscopic examination. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important urinalysis findings at any visit were reported.|Up to Day 28|Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093).|||Participants|||Count of Participants
2567760|NCT02563899|Primary|Number of Participants With Clinical Hematology Abnormalities of Potential Clinical Importance at Any Time on Treatment.|The hematology parameters analyzed were basophils, eosinophils, erythrocyte mean corpuscular hemoglobin concentration, erythrocyte mean corpuscular hemoglobin, erythrocyte mean corpuscular volume, erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, platelets, and reticulocytes. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important hematology findings at any visit were reported.|Up to Day 28|Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093).|||Participants|||Count of Participants
2567761|NCT02563899|Primary|Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance at Any Time on Treatment|The clinical chemistry parameters analyzed were albumin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, bicarbonate, blood urea nitrogen, calcium, chloride, creatinine, gamma glutamyl transferase, glucose, potassium, sodium, total and direct bilirubin, total protein, uric acid. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important clinical chemistry findings at any visit were reported.|Up to day 28|Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093).|||Participants|||Count of Participants
2567762|NCT02563899|Primary|Number of Participants With Abnormal Values of Potential Clinical for Electrocardiogram (ECG)|Single 12-lead ECGs was obtained at Day 1, Day 14 and Day 28 during the study. The standard ECG criteria of potential clinical importance were 1) absolute QTc Interval, > 450 milliseconds (msec), 2) absolute PR Interval, <110 msec, 3) absolute QRS Interval, < 75 msec and 4) increase from baseline in QTc > 60 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Up to Day 28|Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093).|||Participants|||Count of Participants
2567763|NCT02563899|Primary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Event (SAE)|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Over a period of 28 days|Safety population of study number 202093, LHH117157 (Cohort B) and AC4112008 were used to report AEs.|||Participants|||Count of Participants
2567764|NCT02563899|Primary|Composite Population Pharmacokinetics Parameter: Duration of the Zero Order Process and Lag Time for the First Order Absorption Process (ALAG1)|Pharmacokinetic blood sampling was done at Pre-dose, 3h, 6h, 9h, 10h, 12h, 16h, 24h, 36h, 48h of current study (202093), pre-dose, 10, 20, 30, 32, 35, 45 minute, 1h, 2h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h for study AC4112008, and Pre-dose, 2h, 4h, 5h, 6h, 8h, 8.5h, 9h, 9.5h, 10h, 11h, 12h, 13h, 14h, 16h, 24h, 30h, 36h, 48h, 72h for study number LHH117157. Plasma umeclidinium concentration time data following administration to axilae of hyperhidrosis participants from the current study (202093) were pooled with data from the occluded axilla cohort from study LHH117157 and the IV infusion data from study AC4112008 in order modify the existing population PK model for dermal umeclidinium. Plasma concentration-time data was subjected to nonlinear mixed effects modelling using the program NONMEM to develop a population PK model. The data for ALAG1 was reported as mean (estimate) with RSE. RSE= (Standard error of the estimate/ Final parameter estimate) x 100.|Day 12 to Day 16|Pharmacokinetic Concentration Populations from studies 202093 (16 participants), AC4112008 (9 participants) and LHH117157 (6 participants) were pooled to population PK parameter analysis.|||h||Standard Error|Mean
2567772|NCT02563899|Primary|Mean Time to Reach Cmax (Tmax) of Umeclidinium After Repeat Dosing|Pharmacokinetic blood sampling was done at Day 14 (pre-dose), Day 15 (3 h, 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose). Tmax was determined directly from the concentration-time data.|Day 14 to Day 16|Pharmacokinetic Concentration Population. Only those participants available at the specified time points were analyzed.|||h||Standard Deviation|Mean
2567765|NCT02563899|Primary|Composite Population Pharmacokinetics Parameter: Absolute Plasma Bioavailability Following Administration to Axilae (FA) Fraction of the Bioavailable Drug Absorbed Through a Zero Order Process (F2 [FIXED])|Pharmacokinetic blood sampling was done at Pre-dose, 3h, 6h, 9h, 10h, 12h, 16h, 24h, 36h, 48h of current study (202093), pre-dose, 10, 20, 30, 32, 35, 45 minute, 1h, 2h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h for study AC4112008, and Pre-dose, 2h, 4h, 5h, 6h, 8h, 8.5h, 9h, 9.5h, 10h, 11h, 12h, 13h, 14h, 16h, 24h, 30h, 36h, 48h, 72h for study number LHH117157. Plasma umeclidinium concentration time data following administration to axilae of hyperhidrosis participants from the current study (202093) were pooled with data from the occluded axilla cohort from study LHH117157 and the IV infusion data from study AC4112008 in order modify the existing population PK model for dermal umeclidinium. Plasma concentration-time data was subjected to nonlinear mixed effects modelling using the program NONMEM to develop a population PK model. The data for FA and F2 (FIXED) was reported as mean (estimate) with RSE. RSE= (Standard error of the estimate/ Final parameter estimate) x 100.|Day 12 to Day 16|Pharmacokinetic Concentration Populations from studies 202093 (16 participants), AC4112008 (9 participants) and LHH117157 (6 participants) were pooled to population PK parameter analysis.|||Ratio||Standard Error|Mean
2567766|NCT02563899|Primary|Composite Population Pharmacokinetics Parameter: Absorption Rate Constant (Ka)|Pharmacokinetic blood sampling was done at Pre-dose, 3h, 6h, 9h, 10h, 12h, 16h, 24h, 36h, 48h of current study (202093), pre-dose, 10, 20, 30, 32, 35, 45 minute, 1h, 2h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h for study AC4112008, and Pre-dose, 2h, 4h, 5h, 6h, 8h, 8.5h, 9h, 9.5h, 10h, 11h, 12h, 13h, 14h, 16h, 24h, 30h, 36h, 48h, 72h for study number LHH117157. Plasma umeclidinium concentration time data following administration to axilae of hyperhidrosis participants from the current study (202093) were pooled with data from the occluded axilla cohort from study LHH117157 and the IV infusion data from study AC4112008 in order modify the existing population PK model for dermal umeclidinium. Plasma concentration-time data was subjected to nonlinear mixed effects modelling using the program NONMEM to develop a population PK model. The data for Ka was reported as mean (estimate) with RSE. RSE= (Standard error of the estimate/ Final parameter estimate) X 100.|Day 12 to Day 16|Pharmacokinetic Concentration Populations from studies 202093 (16 participants), AC4112008 (9 participants) and LHH117157 (6 participants) were pooled to population Pk parameter analysis.|||1/h||Standard Error|Mean
2567767|NCT02563899|Primary|Composite Population Pharmacokinetics Parameter: Elimination Clearance (CL) and Inter-compartmental Clearance (Q)|Pharmacokinetic blood sampling was done at Pre-dose, 3h, 6h, 9h, 10h, 12h, 16h, 24h, 36h, 48h of current study (202093), pre-dose, 10, 20, 30, 32, 35, 45 minute, 1h, 2h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h for study AC4112008, and Pre-dose, 2h, 4h, 5h, 6h, 8h, 8.5h, 9h, 9.5h, 10h, 11h, 12h, 13h, 14h, 16h, 24h, 30h, 36h, 48h, 72h for study number LHH117157. Plasma umeclidinium concentration time data following administration to axilae of hyperhidrosis participants from the current study (202093) were pooled with data from the occluded axilla cohort from study LHH117157 and the IV infusion data from study AC4112008 in order modify the existing population PK model for dermal umeclidinium. Plasma concentration-time data was subjected to nonlinear mixed effects modelling using the program NONMEM to develop a population PK model. The data for CL and Q was reported as mean (estimate) with RSE. RSE= (Standard error of the estimate/ Final parameter estimate) X 100.|Day 12 to Day 16|Pharmacokinetic Concentration Populations from studies 202093 (16 participants), AC4112008 (9 participants) and LHH117157 (6 participants) were pooled to population Pk parameter analysis.|||L/h||Standard Error|Mean
2567768|NCT02563899|Primary|Composite Population Pharmacokinetics Parameter: Volume of Distribution in Central Compartment (V1) and Volume of Distribution in Peripheral Compartment (V2)|Pharmacokinetic blood sampling was done at Pre-dose, 3h, 6h, 9h, 10h, 12h, 16h, 24h, 36h, 48h of current study (202093), pre-dose, 10, 20, 30, 32, 35, 45 minute, 1h, 2h, 4h, 6h, 8h, 12h, 16h, 24h, 36h, 48h for study AC4112008, and Pre-dose, 2h, 4h, 5h, 6h, 8h, 8.5h, 9h, 9.5h, 10h, 11h, 12h, 13h, 14h, 16h, 24h, 30h, 36h, 48h, 72h for study number LHH117157. Plasma umeclidinium concentration time data following administration to axilae of hyperhidrosis participants from the current study (202093) were pooled with data from the occluded axilla cohort from study LHH117157 and the IV infusion data from study AC4112008 in order modify the existing population PK model for dermal umeclidinium. Plasma concentration-time data was subjected to nonlinear mixed effects modelling using the program NONMEM to develop a population PK model. The data for V1 and V2 was reported as mean (estimate) with relative standard error (RSE). RSE= (Standard error of the estimate/ Final parameter estimate) X 100.|Day 12 to Day 16|Pharmacokinetic Concentration Populations from studies 202093 (16 participants), AC4112008 (9 participants) and LHH117157 (6 participants) were pooled to population Pk parameter analysis.|||Litre (L)||Standard Error|Mean
2567769|NCT02563899|Primary|Mean Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Across All Treatments (0-t) and AUC Over the Dosing Interval (0-tau) of Umeclidinium After Repeat Dosing|Pharmacokinetic blood sampling was done at Day 14 (pre-dose), Day 15 (3 h, 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose). Calculated using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid. Geometric mean of log-transformed values of AUC were reported.|Day 14 to Day 16|Pharmacokinetic Concentration Population. Only those participants available at the specified time points were analyzed.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2567770|NCT02563899|Primary|Terminal Phase Half-life (t1/2) of Umeclidinium After Repeat Dosing|Pharmacokinetic blood sampling was done at Day 14 (pre-dose), Day 15 (3 h, 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose). Derivation of t1/2 was planned. However, the parameter could not be derived for any of the participant included in the study because of insufficient data in the elimination phase (< 3 data points, coefficient of determination (R^2) was not adequate).|Day 14 to Day 16|Pharmacokinetic Concentration Population||||||
2567771|NCT02563899|Primary|Mean Terminal Plasma Elimination Rate Constant (Lambda Z) of Umeclidinium After Repeat Dosing|Pharmacokinetic blood sampling was done at Day 14 (pre-dose), Day 15 (3 h, 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose). Derivation of lambda-Z was planned. However, the parameter could not be derived for any of the participant included in the study because of insufficient data in the elimination phase (< 3 data points, coefficient of determination (R^2) was not adequate).|Day 14 to Day 16|Pharmacokinetic Concentration Population||||||
2567773|NCT02563899|Primary|Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) After Repeat Dosing of Umeclidinium|Pharmacokinetic blood sampling was done at Day 14 (pre-dose), Day 15 (3 h, 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose). Cmax and Ctau was determined directly from the concentration-time data.|Day 14 (pre-dose), Day 15 (3 h, 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose)|Pharmacokinetic Concentration Population. Only those participants available at the specified time points were analyzed.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2567774|NCT02563899|Primary|Mean Plasma Concentration After Repeat Dosing of Umeclidinium|Pharmacokinetic blood sampling was done at the following time points: Day 12 (pre-dose), Day 13 (pre-dose), Day 14 (pre-dose), Day 15 (3 hours [h], 6 h, 9 h, 10 h, 12 h, 16 h, and 24 h following the Day 14 dose), Day 16 (36 h and 48 h following the Day 14 dose). Approximately 3 ml of blood was taken at each timepoint. Mean and standard deviation of the umeclidinium concentration was reported. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Day 12 to Day 16|Pharmacokinetic Concentration Population defined as all participants in the Safety population for whom at least one pharmacokinetic sample was obtained and analyzed. Safety Population is defined as all participants who received at least one dose of a study drug in this study (202093)|||picogram per millilitre (pg/ml)||Standard Deviation|Mean
2567775|NCT02563860|Secondary|Visual Memory Novelty Score as Assessed by TobiiTX 300 Eyetracking System|"Novelty score is considered a composite measure of visual memory.Test is a standardized neuropsychological test( Rose test) adapted for eye tracking system.~The present study made use of a well-established battery of visual paired comparison problems .There were nine problems: five using achromatic photos of faces and four using multicolored abstract patterns paired stimuli , separated by 23°. For each problem, two identical stimuli are briefly presented side by side for familiarization, then the familiar and a new one are paired on test~Recognition(memory) is indexed by a novelty score (percentage of looking to the novel target on test).~Higher novelty scores were related to better recognition (index of better memory) Scores range from 0.0-1.0 (0-100%) and indicate 1) more overall looking at novel target and (2) more fixations to novel targets.~Score of .5 (50%) indicates looking by change only with no recognition."|final week of treatment, Week 32|Calculation done on intent-to-treat population|||percent||Inter-Quartile Range|Median
2567776|NCT02563860|Primary|Gait Velocity as Measured by GAITRite System|To perform quantitative gait assessment using a computerized walkway with embedded pressure sendors (GAIT rite)|During final week of treatment, week 32||||cm/sec||Inter-Quartile Range|Median
2567777|NCT02563834|Secondary|Myocardial Perfusion Rate|PET measure of total myocardial perfusion (blood flow)|4 Hours||||ml/min/100g||Standard Error|Mean
2567778|NCT02563834|Secondary|Myocardial Oxidation Rate|PET measure of total oxidation rate|4 Hours||||ml/min/100g||Standard Error|Mean
2567779|NCT02563834|Primary|Myocardial Fatty Acid Uptake Rate|PET measure of fatty acid uptake rate|4 Hours||||umol/min/100g||Standard Error|Mean
2567780|NCT02563808|Primary|Difference in Consideration of Regret|Compare decisions about a hypothetical surgery for breast cancer, and examined whether regret is a consideration in treatment decisions between those who received the experimental and those who received the standard version of the decision aid. The values represent numbers of participants who reported that regret played a role in their decision-making.|11 months||||participants reported regret played role|||Number
2567781|NCT02563548|Secondary|Dose-Expansion Phase: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)|ECGs including clinical significance was evaluated by the Investigator. Criteria for clinical significance were as per investigator's discretion.|Cycle 1 Day 1 up to 30 days after last dose of study drug (maximum exposure: 60 weeks for GAC, and 46 weeks for NSCLC)|Safety population included all enrolled participants in either the Dose Escalation or Dose Expansion portion of the study, who received at least 1 dose of any study medication (PEGPH20 or pembrolizumab).|||Participants|||Count of Participants
2567782|NCT02563548|Secondary|Dose-Expansion Phase: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters and Vital Signs|Clinical laboratory parameters included hematology (haemoglobin [Hb], hematocrit, red blood cell count, white blood cell count, neutrophils [ANC], lymphocytes, monocytes, eosinophils, basophils, granulocytes, mean corpuscular Hb, mean corpuscular volume, and platelet count) and blood chemistry (glucose, blood urea nitrogen [BUN], alanine aminotransferase [ALT], aspartate aminotransferase [AST], albumin, bilirubin, bicarbonate, calcium, chloride, magnesium, potassium, sodium, thyrotropin, thyroxin, triiodothyronine, alkaline phosphatase [ALP], electrolytes, and creatinine). Vital signs included measurement of blood pressure (systolic and diastolic), pulse, respiratory rate, and body temperature. Criteria for clinical significance were as per investigator's discretion.|Cycle 1 Day 1 up to 30 days after last dose of study drug (maximum exposure: 60 weeks for GAC, and 46 weeks for NSCLC)|Safety population included all enrolled participants in either the Dose Escalation or Dose Expansion portion of the study, who received at least 1 dose of any study medication (PEGPH20 or pembrolizumab).|||Participants|||Count of Participants
2567783|NCT02563548|Secondary|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.|Cycle 1 Day 1 up to 30 days after last dose of study drug (maximum exposure: 60 weeks for GAC, and 46 weeks for NSCLC)|Safety population included all enrolled participants in either the Dose Escalation or Dose Expansion portion of the study, who received at least 1 dose of any study medication (PEGPH20 or pembrolizumab).|||Participants|||Count of Participants
2567784|NCT02563548|Secondary|Dose-Escalation and Expansion Phase: Clearance (CL) of PEGPH20|PK parameters for PEGPH20 were calculated using noncompartmental methods and summarized using descriptive statistics by dose.|Pre PEGPH20 dose (within 2 hours [hrs] pre-dose); 0.25,1, 2-4, and 6-8 hrs post PEGPH20 dose at Cycle 1 Day 1 (cycle length = 21 days)|CL could not be determined due to the AUC% extrapolation of greater than 20%.||||||
2567785|NCT02563548|Secondary|Dose-Escalation and Expansion Phase: Volume of Distribution (Vd) of PEGPH20|PK parameters for PEGPH20 were calculated using noncompartmental methods and summarized using descriptive statistics by dose.|Pre PEGPH20 dose (within 2 hours [hrs] pre-dose); 0.25,1, 2-4, and 6-8 hrs post PEGPH20 dose at Cycle 1 Day 1 (cycle length = 21 days)|Vd could not be determined due to the AUC% extrapolation of greater than 20%.||||||
2567786|NCT02563548|Secondary|Dose-Escalation and Expansion Phase: Area Under the Plasma Concentration Vs. Time Curve From Time 0 to Last Quantifiable Concentration (AUClast) of PEGPH20|PK parameters for PEGPH20 were calculated using noncompartmental methods and summarized using descriptive statistics by dose.|Pre PEGPH20 dose (within 2 hours [hrs] pre-dose); 0.25,1, 2-4, and 6-8 hrs post PEGPH20 dose at Cycle 1 Day 1 (cycle length = 21 days)|Evaluable PK population included participants with at least one PK parameter for PEGPH20 following dosing on Day 1 of Cycle 1.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2567787|NCT02563548|Secondary|Dose-Escalation and Expansion Phase: Terminal Elimination Half-Life (t1/2) of PEGPH20|PK parameters for PEGPH20 were calculated using noncompartmental methods and summarized using descriptive statistics by dose.|Pre PEGPH20 dose (within 2 hours [hrs] pre-dose); 0.25,1, 2-4, and 6-8 hrs post PEGPH20 dose at Cycle 1 Day 1 (cycle length = 21 days)|Evaluable PK population included participants with at least one PK parameter for PEGPH20 following dosing on Day 1 of Cycle 1. 'Overall number of participants analyzed'=participants evaluable for this outcome measure.|||hours||Standard Deviation|Mean
2567788|NCT02563548|Secondary|Dose-Escalation and Expansion Phase: Maximum Observed Plasma Concentration (Cmax) of PEGPH20|Pharmacokinetic (PK) parameters for PEGPH20 were calculated using noncompartmental methods and summarized using descriptive statistics by dose.|Pre PEGPH20 dose (within 2 hours [hrs] pre-dose); 0.25,1, 2-4, and 6-8 hrs post PEGPH20 dose at Cycle 1 Day 1 (cycle length = 21 days)|Evaluable PK population included participants with at least one PK parameter for PEGPH20 following dosing on Day 1 of Cycle 1.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2567789|NCT02563548|Secondary|Dose- Expansion Phase: PFS, as Assessed by Investigator Based on irRC|PFS was defined as the time from first dose date until the first occurrence of either radiographic or clinical disease progression as determined by the Investigator or death from any cause before discontinuation from treatment. Disease progression was defined as at least a 20% increase in tumor burden from nadir. PFS was analyzed using Kaplan-Meier methods.|From first dose until the first occurrence of either radiographic or clinical disease progression or death from any cause (maximum exposure: 60 weeks for GAC, and 46 weeks for NSCLC)|Efficacy evaluable population included all HA-high participants who received at least 1 dose of the RP2D of PEGPH20 and at least 1 dose of pembrolizumab.|||months||80% Confidence Interval|Median
2567790|NCT02563548|Secondary|Dose- Expansion Phase: DCR, as Assessed by Investigator Based on irRC: Percentage of Participants Who Achieved CR, PR or SD|DCR was defined as percentage of participants who achieved CR, PR, or stable disease (SD). CR was defined as disappearance of all lesions including non-index lesions and new non-measurable lesions, lymph nodes must be <10 mm in short axis). PR was defined as at least a 30% decrease in tumor burden from baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in tumor burden from nadir.|From first dose until first occurrence of CR, PR or SD (maximum exposure: 60 weeks for GAC, and 46 weeks for NSCLC)|Tumor response evaluable population included all HA-high participants who received at least 1 dose of the RP2D of PEGPH20 and at least 1 dose of pembrolizumab; and who had at least one post-baseline tumor assessment on or post Cycle 2.|||percentage of participants||80% Confidence Interval|Number
2567791|NCT02563548|Secondary|Dose- Expansion Phase: DOR, as Assessed by Investigator Based on irRC|DOR was defined as the time from the date on which objective response (CR or PR) was first determined until the first date on which radiographic disease progression was determined. CR was defined as disappearance of all lesions including non-index lesions and new non-measurable lesions, lymph nodes must be <10 mm in short axis). PR was defined as at least a 30% decrease in tumor burden from baseline. Disease progression was defined as at least a 20% increase in tumor burden from nadir. DOR was analyzed using Kaplan-Meier methods.|From the date of first objective response (CR or PR) until the date of first radiographic disease progression (maximum exposure: 60 weeks for GAC, and 46 weeks for NSCLC)|Tumor response evaluable population included all HA-high participants who received at least 1 dose of the RP2D of PEGPH20 and at least 1 dose of pembrolizumab; and who had at least one post-baseline tumor assessment on or post Cycle 2. 'Overall number of participants analyzed'=participants with a confirmed objective response.|||months||80% Confidence Interval|Median
2567792|NCT02563548|Secondary|Dose Expansion Phase: Objective Response Rate (ORR): Percentage of Participants With Objective Response, as Assessed by Investigator Based on Immune-Response Related Criteria (irRC)|ORR was defined as percentage of participants who achieved either CR or PR, as assessed by investigator based on irRC. CR was defined as disappearance of all lesions including non-index lesions and new non-measurable lesions, lymph nodes must be <10 mm in short axis). PR was defined as at least a 30% decrease in tumor burden from baseline.|Cycle 1 Day 1 of dose-expansion phase until death, disease progression, or unacceptable toxicity (maximum exposure: 60 weeks for GAC, and 46 weeks for NSCLC)|Tumor response evaluable population included all HA-high participants who received at least 1 dose of the RP2D of PEGPH20 and at least 1 dose of pembrolizumab; and who had at least one post-baseline tumor assessment on or post Cycle 2.|||percentage of participants||80% Confidence Interval|Number
2567793|NCT02563548|Secondary|Dose-Escalation and Expansion Phase: Overall Survival|Overall survival was defined as the time from first dose date until death from any cause. Overall survival was analyzed using Kaplan-Meier methods.|From first dose until death from any cause (maximum exposure: 46 weeks for GAC, and 27 weeks for NSCLC in dose-escalation phase; maximum exposure: 60 weeks for GAC, and 46 weeks for NSCLC in dose-expansion phase)|Efficacy evaluable population included all HA-high participants who received at least 1 dose of the RP2D of PEGPH20 and at least 1 dose of pembrolizumab.|||months||80% Confidence Interval|Median
2567877|NCT02561585|Secondary|Hair Length|Hair length measured in millimeters.|At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)|The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis.|||mm||Standard Deviation|Mean
2567794|NCT02563548|Secondary|Dose-Escalation and Expansion Phase: Progression-Free Survival (PFS), as Assessed by Investigator Based on RECIST v1.1|PFS was defined as the time from first dose date until the first occurrence of either radiographic or clinical disease progression as determined by the Investigator or death from any cause before discontinuation from treatment. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study thus far, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. PFS was analyzed using Kaplan-Meier methods.|From first dose until first occurrence of either radiographic or clinical disease progression or death (maximum exposure: 46 weeks for GAC, and 27 weeks for NSCLC in dose-escalation; 60 weeks for GAC, and 46 weeks for NSCLC in dose-expansion)|Efficacy evaluable population included all HA-high participants who received at least 1 dose of the RP2D of PEGPH20 and at least 1 dose of pembrolizumab.|||months||80% Confidence Interval|Median
2567795|NCT02563548|Secondary|Dose-Escalation and Expansion Phase: Disease Control Rate (DCR), as Assessed by Investigator Based on RECIST v1.1: Percentage of Participants Who Achieved CR, PR or Stable Disease (SD)|DCR was defined as percentage of participants who achieved CR, PR, or stable disease (SD). CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study thus far, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of one or more new lesions; and unequivocal progression of existing non-target lesions.|From first dose until first occurrence of CR, PR or SD (maximum exposure: 46 weeks for GAC, and 27 weeks for NSCLC in dose-escalation phase; maximum exposure: 60 weeks for GAC, and 46 weeks for NSCLC in dose-expansion phase)|Tumor response evaluable population included all HA-high participants who received at least 1 dose of the RP2D of PEGPH20 and at least 1 dose of pembrolizumab; and who had at least one post-baseline tumor assessment on or post Cycle 2.|||percentage of participants||80% Confidence Interval|Number
2567796|NCT02563548|Secondary|Dose-Escalation and Expansion Phase: Duration of Response (DOR), as Assessed by Investigator Based on RECIST v1.1|DOR was defined as the time from the date on which objective response (CR or PR) was first determined until the first date on which radiographic disease progression was determined. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study thus far, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of one or more new lesions; and unequivocal progression of existing non-target lesions. DOR was analyzed using Kaplan-Meier methods.|From date of first objective response (CR or PR) until date of first radiographic disease progression (maximum exposure: 46 weeks for GAC, and 27 weeks for NSCLC in dose-escalation; 60 weeks for GAC, and 46 weeks for NSCLC in dose-expansion)|Tumor response evaluable population included all HA-high participants who received at least 1 dose of the RP2D of PEGPH20 and at least 1 dose of pembrolizumab; and who had at least one post-baseline tumor assessment on or post Cycle 2. 'Overall number of participants analyzed'=participants with a confirmed objective response.|||months||80% Confidence Interval|Median
2567797|NCT02563548|Secondary|Dose-Escalation Phase: ORR: Percentage of Participants With Objective Response, as Assessed by Investigator Based on RECIST Version 1.1|ORR was defined as percentage of participants who achieved either a CR or PR, as assessed by investigator based on RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Cycle 1 Day 1 of dose-escalation phase until death, disease progression, or unacceptable toxicity (maximum exposure: 46 weeks for GAC, and 27 weeks for NSCLC)|Tumor response evaluable population included all HA-high participants who received at least 1 dose of the RP2D of PEGPH20 and at least 1 dose of pembrolizumab; and who had at least one post-baseline tumor assessment on or post Cycle 2.|||percentage of participants||80% Confidence Interval|Number
2567798|NCT02563548|Primary|Dose Expansion Phase: Objective Response Rate (ORR): Percentage of Participants With Objective Response, as Assessed by Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|ORR was defined as percentage of participants who achieved either a complete response (CR) or partial response (PR), as assessed by investigator based on RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions; Any pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Cycle 1 Day 1 of dose-expansion phase until death, disease progression, or unacceptable toxicity (maximum exposure: 60 weeks for GAC, and 46 weeks for NSCLC)|Tumor response evaluable population included all hyaluronan- high (HA-high) participants who received at least 1 dose of the RP2D of PEGPH20 and at least 1 dose of pembrolizumab; and who had at least one post-baseline tumor assessment on or post Cycle 2.|||percentage of participants||80% Confidence Interval|Number
2567799|NCT02563548|Primary|Dose Escalation Phase: Recommended Phase 2 Dose (RP2D) of PEGPH20 in Combination With Pembrolizumab|The RP2D was determined based on the overall safety profile of the participants enrolled during the dose-escalation part of the study.|Cycle 1 (21 days)|DLT evaluable population included all participants enrolled in dose escalation part who received at least 1 of the 3 full planned doses of PEGPH20 and 1 complete dose of pembrolizumab in Cycle 1 and had been followed for the first 21 days of treatment or had experienced a DLT during the initial 21 days (Cycle 1) of the study.|||µg/kg|||Number
2568197|NCT02556918|Secondary|Number of Patients With Hypoglycemic Events in Intensive Care Unit (ICU)|Number of patients with events (blood glucose less than 70 mg/dL) in patients in intensive care unit (ICU).|2 days (average time of discharge from ICU)||||Participants|||Count of Participants
2567800|NCT02563548|Primary|Dose-Escalation Phase: Maximum Tolerated Dose (MTD) of PEGPH20 in Combination With Pembrolizumab|MTD of PEGPEM combination (PEGPH20 + Pembrolizumab) was defined as the highest dose level at which no more than 1 of 6 evaluable participants had experienced a DLT in the first 3 weeks of treatment. DLT was defined as any of the following: i) Any treatment-emergent Grade greater than or equal to (≥) 3 toxicity that was considered related to either PEGPH20 or pembrolizumab or the combination of PEGPH20 and pembrolizumab (nausea, vomiting, MSEs, and diarrhea were considered DLTs only if they reached Grade ≥ 3 despite adequate supportive care measures); ii) Grade 3 musculoskeletal events (MSEs) were considered DLTs only if they did not reduce to Grade ≤ 2 within 48 hours despite therapeutic intervention; iii) Hypersensitivity/infusion reactions related to PEGPH20 or pembrolizumab dosing were not considered DLTs (hypersensitivity reactions were generally not related to the dose level of a drug since they could occur even upon a low level of exposure).|Cycle 1 (21 days)|After 9 participants enrolled in “Dose Escalation: PEGPH20 2.2 µg/kg + Pembrolizumab” group with only 1 DLT, the Sponsor decided to stop further dose escalation beyond 2.2 μg/kg, hence MTD was not established.||||||
2567801|NCT02563548|Primary|Dose-Escalation Phase: Number of Participants With Dose-Limiting Toxicity (DLT)|DLTs were defined as any of the following: i) Any treatment-emergent Grade greater than or equal to (≥) 3 toxicity that was considered related to either PEGPH20 or pembrolizumab or the combination of PEGPH20 and pembrolizumab (nausea, vomiting, MSEs, and diarrhea were considered DLTs only if they reached Grade ≥ 3 despite adequate supportive care measures); ii) Grade 3 musculoskeletal events (MSEs) were considered DLTs only if they did not reduce to Grade ≤ 2 within 48 hours despite therapeutic intervention; iii) Hypersensitivity/infusion reactions related to PEGPH20 or pembrolizumab dosing were not considered DLTs (hypersensitivity reactions were generally not related to the dose level of a drug since they could occur even upon a low level of exposure).|Cycle 1 (21 days)|DLT evaluable population included all participants enrolled in dose escalation part who received at least 1 of the 3 full planned doses of PEGPH20 and 1 complete dose of pembrolizumab in Cycle 1 and had been followed for the first 21 days of treatment or had experienced a DLT during the initial 21 days (Cycle 1) of the study.|||Participants|||Count of Participants
2567802|NCT02563106|Primary|Percentage of Patients With Clostridium Difficile Infection at 4- Weeks of Follow-up.|Percentage of subjects with CDI, based on the protocol definition of CDI (defined as 3 or more unformed stools per 24 hour period and a stool sample being positive for C. difficile toxin A and/or B [or their respective genes, tcdA and/or tcdB], based on the clinical site local laboratory results) from Day 1 to the 4-week Follow-up Visit in the SYN-004 treatment group compared to the placebo group, imputing early termination without CDI as not being treatment failures.|Day 1 to the 4 week Follow-up Visit.|The Modified Intent-to-Treat (mITT) analysis set included randomized subjects who received at least 1dose of study drug. Number of subjects with CDI, imputing early termination without CDI as not being treatment failures.|||Participants|||Count of Participants
2567803|NCT02563093|Secondary|Geometric Mean Titer Ratios of Influenza Antibodies Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay.|21 days post-vaccination|Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.|||Titer ratio||95% Confidence Interval|Geometric Mean
2567804|NCT02563093|Secondary|Number of Participants Achieving Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroconversion was defined as either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in titer post-vaccination.|21 days post-vaccination|Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.|||Participants|||Number
2567805|NCT02563093|Secondary|Number of Participants Achieving Seroprotection Pre and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroprotection was defined as the number of participants with a titer ≥ 40 (1/dilution) at pre-vaccination and 21 days post-vaccination.|Day 0 (Pre-vaccination) and 21 days post-vaccination|Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.|||Participants|||Number
2567806|NCT02563093|Secondary|Geometric Mean Titers of Influenza Antibodies Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay.|Day 0 (pre-vaccination) and 21 days post-vaccination|Anti-influenza antibodies were assessed in the Per-protocol Analysis Set.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
2567807|NCT02563093|Primary|Number of Participants With Solicited Injection-Site or Systemic Reactions After Receipt of the 2015-2016 Formulation of Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose Vaccine|"Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 solicited injection-site reactions: Pain, Significant; prevents daily activity. Erythema, Swelling, Induration, and Ecchymosis >100 mm. Grade 3 solicited systemic reactions: Fever, ≥ 39.0°C or ≥ 102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity.~A participant (18 to < 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was excluded from the Per-protocol analysis Set and was included in the Fluzone Quadrivalent vaccine Group in the Safety Analysis Set and the assigned group in the Full Analysis Set."|Day 0 up to Day 7 post-vaccination|The vaccine safety outcomes were assessed in the Safety Analysis Set. A participant (18 to < 65 Years) who was assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to < 65 Years) group in the Safety Analysis Set.|||Participants|||Number
2567808|NCT02563028|Secondary|Number of Participants With Intolerance to the SightSaver Visual Stimulator|Whether the SightSaverTM Visual Stimulator is well tolerated by patients. This outcome will be assessed in the PACU will comprise a clinical exam of the periorbital structures and a patient questionnaire|Postoperatively, after recovery from anesthesia (approximately 3 hours after surgery)||||Participants|||Count of Participants
2567809|NCT02563028|Secondary|Correlation of Change in VEPs With Identifiable Intraoperative Event|Whether changes in VEPs vary with any identifiable intraoperative change in patient condition (including hypotension, hypertension, tachycardia, bradycardia, arrhythmias, oxygen saturation, CO2 level, hypothermia and hyperthermia), surgical event (including sudden or ongoing hemorrhage, neurological injury), or anesthetic change (including increasing/decreasing doses of anesthetics, depth of anesthesia and use of vasoactive drugs). This outcome will be measured in realtime, intraoperatively. Number of participants with change in VEPs associated with increases or decreases of isoflurane and nitrous oxide are reported.|Duration of surgery (approximately 3 hours)|Correlation of change in VEPs was qualitatively examined in 18 patients, but not systematically quantified.|||participants|||Number
2567810|NCT02563028|Secondary|Number of Participants With Change in VEP Signal Strength|Number of participants with change in VEP signal strength. This outcome will be measured in realtime, intraoperatively.|Duration of surgery (approximately 3 hours)|Patients who were >18 years old and were undergoing posterior spine surgery with general anesthesia were approached for the study. Eligible surgeries were microdiscectomy or instrumented fusion (lumbar, thoracic, or thoraco-lumbar). There were no restrictions on the number of surgical levels for inclusion in the study.|||Participants|||Count of Participants
2567811|NCT02563028|Primary|Number of Participants With Presence of VEPs|The primary outcome will be the presence of VEPs during spine surgery. This outcome will be measured in realtime, intraoperatively. Outcome measure: Visual evoked potential morphology, varying in amplitude (µV) and latency.|Duration of surgery (approximately 3 hours)|Patients >18 years old who underwent posterior spine surgery with general anesthesia were enrolled. Surgeries were microdiscectomy or instrumented fusion, irrespective of surgical type or patient position (supine or prone).|||Participants|||Count of Participants
2567812|NCT02562989|Primary|Intra-subject Test-Retest (T-RT) Variability of Standardized Uptake Value Ratio (SUVR) in Brain Regions of Interest|"For each AD/MCI participant receiving 2 doses of MK-6240, the SUVR (60-90 min) during initial dose (SUVR_1) was compared to the SUVR (60-90 min) during the second dose (SUVR_2) to determine the percent test-retest (T-RT) variability of the SUVR (60-90 min) for each brain ROI.~T-RT variability = (absolute value (SUVR_1 - SUVR_2) / average SUVR) * 100. If T-RT variability = 0, indicates no variability between SUVR_1 and SUVR_2."|Up to 16 weeks following initial dose of [18F]MK-6240|Includes only elderly AD/MCI participants (Part 2); per protocol, young (Part 1) and elderly (Part 2) healthy participants did not receive retest scan. Of the 6 AD/MCI participants, only 2 received T-RT scans. In one participant, motion artifacts prevented T-RT analysis. For the one participant included, T-RT scans were separated by 16 weeks.|||Percent|||Number
2567813|NCT02562989|Primary|Standardized Uptake Value Ratio (SUVR) of [18F]MK-6240 in Brain Regions of Interest|"As a surrogate of regional [18F[MK-6240 tracer distribution volume (VT), mean standardized uptake value ratios (SUVRs), were calculated for specific brain regions of interest (ROIs) in healthy elderly as well as AD/MCI elderly participants in Part 2 of the study. Calculated using calibrated PET scan images from each participant, SUVR is the relative ratio of pixel intensities at a specific brain ROI compared to a reference region (RR; cerebellar cortex, for this study). For an individual participant, the average SUVR for each brain ROI is calculated starting at 60 minutes and ending at 90 minutes following [18F]MK-6240 administration to quantify tracer retention; referred to as SUVR (60-90min).~An SUVR (60-90 min) < 1 indicates decreased tracer retention at brain ROI relative to RR.~An SUVR (60-90 min) = 1 indicates no difference in tracer retention at brain ROI relative to RR.~An SUVR (60-90 min) > 1 indicates increased tracer retention at brain ROI relative to RR."|From 60 to 90 minutes following [18F]MK-6240 administration|The analysis population included healthy elderly as well as AD/amnesic MCI participants enrolled in Part 2 of this study. As per study protocol, participants enrolled in Part 1 did not receive testing for SUVR (60-90 min) and, as a result, were not included in the analysis population.|||SUVR (60-90 min)||Standard Deviation|Mean
2567814|NCT02562989|Primary|Organ Effective Dose of [18F]MK-6240|Mean organ ED of [18F]MK-6240 was calculated from WB PET scans of healthy young participants included in Part 1 of study. Organ ED, reported as micrograys (µGy) / MBq, is a measure of organ-specific radiation exposure risk. Following [18F]MK-6240 PET tracer administration, organ-specific TACs and radioactivity residence times were utilized to calculate organ ED for specific organs of the body.|Up to approximately 5 hours following [18F]MK-6240 administration|The analysis population included only healthy young participants enrolled in Part 1 of this study (N=3). As per study protocol, participants enrolled in Part 2 did not receive testing for effective dose of [18F]MK-6240 and, as a result, were not included in the analysis population.|||µGy / MBq||Standard Deviation|Mean
2567815|NCT02562989|Primary|Effective Dose of [18F]MK-6240|Mean effective dose (ED) of [18F]MK-6240 was calculated from whole-body (WB) PET scans of healthy young participants included in Part 1 of study. ED, reported as microsieverts (µSv) / megabecquerel (MBq), is a measure of WB radiation exposure risk that accounts for differences in individual organ exposure and organ susceptibility to ionizing radiation. Following [18F]MK-6240 PET tracer administration, organ-specific time-activity curves (TACs) and radioactivity residence times were utilized to calculate exposure risk for individual organs. These values calculated for individual organs were then entered into a human biodistribution model to determine ED of [18F]MK-6240.|Up to approximately 5 hours following [18F]MK-6240 administration|The analysis population included only healthy young participants enrolled in Part 1 of this study (N=3). As per study protocol, participants enrolled in Part 2 did not receive testing for effective dose of [18F]MK-6240 and, as a result, were not included in the analysis population.|||µSv / MBq||Standard Deviation|Mean
2567816|NCT02562989|Primary|Number of Participants Who Discontinued Study Due to an AE|The number of participants discontinuing study due to an AE was monitored.|Part 1: Up to 5 weeks; Part 2: up to 16 weeks|All participants as treated, consisting of all participants who received at least 1 dose of [18F]MK-6240|||Participants|||Count of Participants
2567817|NCT02562989|Primary|Number of Participants With Adverse Events (AEs)|The number of participants experiencing an adverse event (AE) was monitored. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening of a preexisting condition that is temporally associated with the use of the study treatment is also considered an AE.|Part 1: Up to 5 weeks; Part 2: up to 16 weeks|All participants as treated, consisting of all participants who received at least 1 dose of [18F]MK-6240|||Participants|||Count of Participants
2567818|NCT02562924|Secondary|Change in SNOT-22 Nasal Symptom Scores|"The SNOT-22 consists of 22 questions; items 1 to 12 represent the physical problems associated with rhinosinusitis, items 13 to 18 represent the functional limitations, and items 20 to 22 represent the emotional consequences. Each question is scored by the patient from 0 (no problem) to 5 (the problem is as bad as it can be).~The first seven questions relate to nasal symptoms. The nasal symptoms score is calculated by summing the scores for these first seven questions. The range is 0 to 35. Higher scores reflect more severe quality of life impairment as subjectively reported by the patient. The nasal symptom scores from the 3 study groups are compared for the average change in score from baseline to day 119."|119 days|The population analyzed for this outcome is the population of participants for which we had data points at day 119. Please note that this is different than the number of participants that completed the study (Budesonide: 13 enrolled, 11 analyzed; MEDIHONEY: 12 enrolled, 6 analyzed; MEDIHONEY and budesonide: 12 enrolled, 9 analyzed).|||score on a scale||Standard Deviation|Mean
2567819|NCT02562924|Secondary|Change in Sinonasal Outcome Test (SNOT-22) Questionnaire Score|The SNOT-22 consists of 22 questions; items 1 to 12 represent the physical problems associated with rhinosinusitis, items 13 to 18 represent the functional limitations, and items 20 to 22 represent the emotional consequences. Each question is scored by the patient from 0 (no problem) to 5 (the problem is as bad as it can be). The overall score can theoretically range from 0 to 110, with higher scores reflecting more severe quality of life impairment as subjectively reported by the patient. Overall SNOT-22 scores from the 3 study groups are compared for the average change in score from baseline to day 119.|119 days|The population analyzed for this outcome is the population of participants for which we had data points at day 119. Please note that this is different than the number of participants that completed the study (Budesonide: 13 enrolled, 11 analyzed; MEDIHONEY: 12 enrolled, 6 analyzed; MEDIHONEY and budesonide: 12 enrolled, 9 analyzed).|||score on a scale||Standard Deviation|Mean
2567820|NCT02562924|Secondary|Nasal Drainage Cultures|Nasal drainage cultures from the 3 study groups will be compared for the average percent change between a patient's positive intraoperative cultures compared to the patient's cultures at day 35.|35 days|This secondary objective describes analyzing quantitative changes in microbiology between day of surgery and post-operative day 35. These data were not collected, but rather the qualitative data (which microorganisms were present) were. Therefore we are not able to complete analysis on this secondary objective.||||||
2567821|NCT02562924|Primary|Change in Lund-Kennedy Endoscopic Scores|"Characteristics of each sinonasal cavity are assessed endoscopically to provide a score based on polyp disease, mucosal edema/crusting/scarring and nasal secretions. A score is provided for the left and right. The scores are totaled to provide a number between 0 and 20.~Polyps: 0 = absence of polyp; 1 = polyps in middle meatus only; 2 = polyps beyond middle meatus Edema: 0 = absent; 1 = mild; 2 = severe Discharge: 0 = no discharge; 1 = clear, thin discharge; 2 = thick, purulent discharge Scarring: 0 = absent; 1 = mild; 2 = severe Crusting: 0 = absent; 1 = mild; 2 = severe~This scoring system has since been the instrument of choice to endoscopically evaluate outcomes of interventions in non-neoplastic sinonasal disease prospectively over time in research and clinical practice. The higher the score, the worse the outcome. Endoscopy scores from the 3 study groups are compared for the average unit change between baseline and day 119."|119 days|The population analyzed for this outcome is the population of participants for which we had data points at day 119. Please note that this is different than the number of participants that completed the study (Budesonide: 13 enrolled, 11 analyzed; MEDIHONEY: 12 enrolled, 6 analyzed; MEDIHONEY and budesonide: 12 enrolled, 9 analyzed).|||score on a scale||Standard Deviation|Mean
2567822|NCT02562521|Secondary|Wisconsin Predicting Patient's Relapse Questionnaire|Items from the Wisconsin Predicting Patient's Relapse questionnaire (WI-PREPARE) will be administered. This is a brief scale comprised of 7 items that assesses proneness to smoking relapse. Items are summed to create a total score. Total range=1-13 with higher scores indicating greater likelihood of smoking relapse.|Month 6|These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.|||units on a scale||Standard Deviation|Mean
2567823|NCT02562521|Secondary|Wisconsin Predicting Patient's Relapse Questionnaire|Items from the Wisconsin Predicting Patient's Relapse questionnaire (WI-PREPARE) will be administered. This is a brief scale comprised of 7 items that assesses proneness to smoking relapse. Items are summed to create a total score. Total range=1-13 with higher scores indicating greater likelihood of smoking relapse.|Baseline|These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.|||units on a scale||Standard Deviation|Mean
2567824|NCT02562521|Secondary|Number of People Who Quit Smoking at 6 Months|Smoking cessation is operationally defined as successfully quitting smoking at 6 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).|Month 6|These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.|||Participants|||Count of Participants
2567825|NCT02562521|Secondary|Number of People Who Quit Smoking at 5 Months|Smoking cessation is operationally defined as successfully quitting smoking at 5 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).|Month 5|These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.|||Participants|||Count of Participants
2567826|NCT02562521|Secondary|Number of People Who Quit Smoking at 4 Months|Smoking cessation is operationally defined as successfully quitting smoking at 4 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).|Month 4|These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.|||Participants|||Count of Participants
2567827|NCT02562521|Secondary|Number of Participants Who Quit Smoking at 3 Months|Smoking cessation is operationally defined as successfully quitting smoking at 3 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).|Month 3|These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.|||Participants|||Count of Participants
2567828|NCT02562521|Secondary|Number of Participants Who Quit Smoking at 2 Months|Smoking cessation is operationally defined as successfully quitting smoking at 2 months measured with TLFB (a standardized, validated, and reliable experimenter-administered rating scale that will be used to obtain quantity and frequency estimates of smoking) and confirmed with expired breath carbon monoxide reading (CO less than or equal to 4 parts per million).|Month 2|These analyses are conducted for the subset of dining hall employees who enrolled in the treatment program. Results are combined across the treatment and delayed control groups during the follow-up period because both groups received the same treatment components so we did not differentiate outcomes between arm/group during the follow-up period.|||Participants|||Count of Participants
2567829|NCT02562521|Primary|Number of Participants Who Quit Smoking for at Least 24 Hours in the Prior Six Weeks|A survey of dining hall employees will be used to determine the proportion of the dining hall employees who quit smoking for at least 24 hours in the prior six weeks in the treatment and delayed treatment control groups. Values present the number of individuals who report quitting successfully for at least 24 hours among individuals who reported smoking.|6 weeks|These analyses are conducted for the subset of dining hall employees who reported being smokers.|||Participants|||Count of Participants
2567830|NCT02562521|Primary|Number of Participants With a Smoking Quit Attempt in the Prior Six Weeks|A survey of dining hall employees will be used to determine the proportion of the dining hall employees who made a quit attempt in the prior six weeks in the treatment and delayed treatment control groups. Values present the proportion of dining hall employees who smoke who reported making a quit attempt.|6 weeks|These analyses are conducted for the subset of dining hall employees who reported being smokers.|||Participants|||Count of Participants
2567831|NCT02562482|Secondary|Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Modified Intent-to-Treat|Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection.|4 weeks after last study injection|Modified Intent-to-Treat (mITT) population included all enrolled subjects who received at least one injection with non-missing immunogenicity data at their Week 8 visit, without exclusions for protocol deviations or censoring for CHIKV infection|||titer||95% Confidence Interval|Geometric Mean
2567832|NCT02562482|Secondary|Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Intent-to-Treat Population|Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection.|Week 8|Intent-to-Treat (ITT) population included all enrolled subjects, analyzed according to the randomized vaccine, with immunogenicity data.|||titer||95% Confidence Interval|Geometric Mean
2567833|NCT02562482|Secondary|Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT) - Per Protocol Population|Antibody responses as measured by neutralization antibody (NAb) assay 4 weeks after last study injection.|Week 8|Subjects who received 2 injections within window as assigned by the randomization schedule and didn't experience any other major protocol deviations prior to Week 8 visit, including those that were CHIKV-infected prior to receipt of 2nd injection who didn't experience deviations prior to infection. None were CHIKV-infected prior to 2nd injection.|||titer||95% Confidence Interval|Geometric Mean
2567834|NCT02562482|Primary|Number of Subjects With Confirmed Chikungunya Virus (CHIKV) Infection Events|Confirmed Chikungunya infections by positive polymerase chain reaction (PCR) results reported from receipt of first study injection through the last expected study visit at 72 weeks.|Through study completion, an average of 72 weeks after first injection|Population included all enrolled subjects who received at least one injection. Four subjects in Group 1 did not receive product.|||Participants|||Count of Participants
2567835|NCT02562482|Primary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs were reported from receipt of first study injection through the last expected study visit at 72 weeks. Grading (Mild, Moderate, Severe, Life-threatening, and Death) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007). The relationship between a SAE and the study product was assessed by the investigator on the basis of his or her clinical judgment and the definitions outlined in the protocol. A subject with multiple SAEs is counted only once.|Through study completion, an average of 72 weeks after first injection|Population included all enrolled subjects who received at least one injection and provided safety data (via diary card and/or laboratory results) following the injection. Four subjects in Group 1 did not receive product and one subject in Group 2 did not provide a diary card following the first injection and were excluded from analysis.|||Participants|||Count of Participants
2567878|NCT02561585|Secondary|Percentage of Patients Who Achieve 50% Improvement in the SALT Score|The event of having at least 50% reduction in SALT score at Week 12 (Day 84) as compared to baseline (Day 1)|At Week 12 (Day 84)|The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11). Only the participants completing Week 12 have been included in the analysis.|||Participants|||Count of Participants
2567836|NCT02562482|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|"Unsolicited AEs were reported from receipt of first study injection through 4 weeks after the last study injection administered. After the indicated time period through the last expected study visit at 72 weeks, only new chronic medical conditions and SAEs (reported as a separate outcome and in the AE module) were collected as unsolicited AEs. A subject with multiple experiences of the same event is counted once using the event of worst severity. The number reported for Any AE is the number of subjects reporting at least one or more AEs."|Through study completion, an average of 72 weeks after first injection|Population included all enrolled subjects who received at least one injection and provided safety data (via diary card and/or laboratory results) following the injection. Four subjects in Group 1 did not receive product and one subject in Group 2 did not provide a diary card following the first injection and were excluded from analysis.|||Participants|||Count of Participants
2567837|NCT02562482|Primary|Number of Subjects With an Abnormal Laboratory Result|Safety laboratory parameters included hematology (hemoglobin, hematocrit, platelets, red blood cell (RBC), white blood cell (WBC), neutrophil, monocyte, lymphocyte, basophil and eosinophil counts, mean corpuscular volume (MCV)) and chemistry (ALT). Complete blood count, differential, platelet and ALT results were collected at screening (≤ 56 days before enrollment), Day 0 prior to study product administration (baseline), and Days 28 and 56.|4 weeks after last injection|Population included all enrolled subjects who had laboratory results available at any study visit post baseline.|||Participants|||Count of Participants
2567838|NCT02562482|Primary|Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Injection|"Subjects recorded the occurrence of solicited symptoms on a memory aid for 7 days after any injection and reviewed the memory aid with clinic staff at a follow up visit. Subjects are counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for Any Systemic Symptom is the number of subjects reporting any systemic symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007)."|7 days after any injection|Population included all enrolled subjects who received at least one injection and provided safety data (via diary card and/or laboratory results) following the injection. Four subjects in Group 1 did not receive product and one subject in Group 2 did not provide a diary card following the first injection and were excluded from analysis.|||Participants|||Count of Participants
2567839|NCT02562482|Primary|Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Injection|"Subjects recorded the occurrence of solicited symptoms on a memory aid for 7 days after any injection and reviewed the memory aid with clinic staff at a follow up visit. Subjects are counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for Any Local Symptom is the number of subjects reporting any local symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA Guidance - September 2007)."|7 days after any injection|Population included all enrolled subjects who received at least one injection and provided safety data (via diary card and/or laboratory results) following the injection. Four subjects in Group 1 did not receive product and one subject in Group 2 did not provide a diary card following the first injection and were excluded from analysis.|||Participants|||Count of Participants
2567840|NCT02561897|Secondary|Thromboembolic and Cardiovascular Events|Thrombotic events (embolism or stroke) through 6 months following the procedure in the Edoxaban and Warfarin groups and the rates of MACE events through 6 months following the procedure in the Edoxaban and Warfarin groups|Within 6 months of procedure||||Participants|||Count of Participants
2567841|NCT02561897|Primary|Major Bleeding|Major local or systemic bleeding as defined in the protocol at 30 days after implant procedure|Within 30 days of procedure||||Participants|||Count of Participants
2567842|NCT02561832|Primary|Part A: Number of Subjects Reporting Adverse Events (AEs)|Treatment-emergent AEs (TEAEs) defined as events occurring on or after cycle 1, day 1 up to and including 30 days after last dose (approximately 114 days).|From day 1 cycle 1, up to and including 30 days after last dose|Safety analysis set consisting of all subjects who received at least one dose of study treatment|||Participants|||Number
2567843|NCT02561806|Secondary|Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Impairment in Activities Performed Outside of Work|"The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO impairment in activities performed outside of work score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes).~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants(Pts) who received at least 1 dose of study drug & had baseline & post-baseline data for WPAI-PSO impairment in activities performed outside work.~mBOCF:Pts who discontinued treatment due to AE were imputed by their baseline observation, pts who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2567865|NCT02561806|Secondary|Percentage of Participants With a ≥75% Improvement in PASI (PASI 75) From Baseline|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week 12|All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for PASI 75. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
2567844|NCT02561806|Secondary|Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Work Impairment Score.|"The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO work impairment score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes).~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for WPAI-PSO work impairment score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2567845|NCT02561806|Secondary|Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Presenteeism|"The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO Presenteeism score is derived from these questions. each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes).~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for WPAI-PSO presenteeism score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2567846|NCT02561806|Secondary|Change From Baseline on the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Absenteeism|"The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work & WPAI-PSO absenteeism score is derived from these questions. Each WPAI score is expressed as an impairment percentage (0-100), with higher scores representing greater impairment (worse outcomes).~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for WPAI-PSO absenteeism score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2567847|NCT02561806|Secondary|Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) United Kingdom(UK) Population-based Index Score|"The EQ-5D-5L descriptive system comprises 5 dimensions, each with 5 levels. The EQ-5D-5L health states were converted into a single summary index by applying a crosswalk using a UK Population value set to each of the levels in each dimension. This produced patient-level index scores between -0.594 and 1.0 (worse to better health).~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug & had baseline & post-baseline EQ-5D 5L UK population-based index score measurement.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2567848|NCT02561806|Secondary|Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) VAS|The EQ-5D 5L is a standardized measure of health status that includes a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (worst health imaginable)- to 100 (best health imaginable)-millimeter (mm) Visual Analog Scale (VAS). ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects.|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for EQ-5D 5L VAS.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||mm||95% Confidence Interval|Least Squares Mean
2567849|NCT02561806|Secondary|"Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D 5L) Bolt On Psoriasis (PSO) -Index"|"The European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of a descriptive system of the respondent's health which comprises the following 5 dimensions: 1) mobility 2) self-care 3) usual activities 4) pain/discomfort 5) anxiety/depression. The Bolt On PSO is an addition to the EQ-5D-5L that consists of 2 dimensions specific to psoriatic disease: 6) skin irritation (itching) and 7) self-confidence. Index scores for the Bolt On PSO range from 0.0042 to 1.0 (worse to better health).~ANCOVA model was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for EQ-5D 5L Bolt On PSO-Index.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2567850|NCT02561806|Secondary|Change From Baseline on Patient Global Assessment of Disease Severity (PatGA)|"The Patient Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis today from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been.~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for PatGA.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2567851|NCT02561806|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score|"The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. SF-36 acute version was used, which has a 1 week recall period.~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for SF36 MCS score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2567852|NCT02561806|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score;|"The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. Items from 8 domains contribute to the PCS. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. SF-36 acute version was used, which has a 1 week recall period.~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for SF-36 PCS score.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2567853|NCT02561806|Secondary|Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale.|"The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 items questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for HADS anxiety subscale.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2567854|NCT02561806|Secondary|Change From Baseline on the Hospital Anxiety and Depression Scale (HADS) Depression Subscale|"The HADS is a participant-rated instrument used to assess both anxiety and depression. This instrument consists of 14 items questionnaire, each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for HADS depression subscale.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2567855|NCT02561806|Secondary|Percentage of Participants With Dermatology Life Quality Index (DLQI) (0,1)|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment). A score of 0 or 1 indicates no impact of disease on a participants quality of life."|Week 12|All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for DLQI. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
2567856|NCT02561806|Secondary|Change From Baseline on the Skin Pain Visual Analog Scale (VAS) (0,100)|"Skin Pain VAS is a participant administered scale designed to measure skin pain from psoriasis using a 100-millimeter (mm) horizontal VAS. Overall severity of a participant's skin pain from psoriasis at the present time is indicated by placing a single mark on the horizontal scale (0 = no skin pain; 100 = severe skin pain).~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for skin pain VAS.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||mm||95% Confidence Interval|Least Squares Mean
2567857|NCT02561806|Secondary|Change From Baseline in Itch Numeric Rating Scale (NRS)|"The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for Itch NRS.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2567956|NCT02561156|Secondary|Part 2: Cmax: Maximum Observed Plasma Concentration for TAK-653 on Day 6||Day 6 pre-dose at multiple timepoints (up to 24 hours) post dose|The PK analysis set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in urine.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2567858|NCT02561806|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score|"NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail(fn) Ps. This scale is used to evaluate severity of fn bed Ps & fn matrix Ps by area of involvement in the fn unit. fn is divided with imaginary horizontal & longitudinal lines into quadrants. Each fn is given a score for fn bed Ps 0(none) to 4(Ps in 4 quadrants of the fn) & fn matrix Ps 0(none) to 4(Ps in 4 quadrants in matrix), depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed or matrix Ps in each quadrant.NAPSI score of a fn is sum of scores in fn bed & fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from range 0 to 80. Higher scores indicate more severe ps.~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who had nail psoriasis at baseline & received at least 1 dose of study drug and had baseline & post-baseline NAPSI measurement.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2567859|NCT02561806|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score|"The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity).~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who had psoriasis in scalp region at baseline & received at least 1 dose of study drug & had baseline & post-baseline PSSI data.~mBOCF: Participants who discontinued treatment due to AE were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2567860|NCT02561806|Secondary|Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score|"The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no Ps) to 72. (the most severe disease) The PPASI was only assessed if participants have palmoplantar psoriasis at baseline.~ANCOVA model with mBOCF was used to produce LS mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants(Pts) who had psoriasis in palmoplantar regions at baseline & received at least 1 dose of study drug & had baseline & post-baseline PPASI data.~mBOCF:Pts who discontinued treatment due to AE were imputed by their baseline observation, Pts who discontinued due to other reasons were imputed by their last observation."|||units on a scale||95% Confidence Interval|Least Squares Mean
2567861|NCT02561806|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis|"The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb.~ANCOVA model with modified baseline observation carried forward (mBOCF) was used to produce Least Square (LS) mean with baseline, treatment group, region weight group as fixed effects."|Baseline, Week 12|"All randomized participants who received at least 1 dose of study drug & had a baseline & post-baseline measurement for BSA affected by Ps.~mBOCF: Participants who discontinued treatment due to Adverse Event (AE) were imputed by their baseline observation, Participants who discontinued due to other reasons were imputed by their last observation."|||Percent Body Surface Affected||95% Confidence Interval|Least Squares Mean
2567862|NCT02561806|Secondary|Percentage of Participants With a sPGA (0) Remission|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA assessed as 0, indicates complete resolution of plaque Ps.|Week 12|All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for sPGA (0). Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
2567863|NCT02561806|Secondary|Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) With at Least a 2-Point Improvement From Baseline|"The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline."|Week 12|All randomized participants with baseline sPGA >=3 & received at least 1 dose of study drug and had a post-baseline measurement for sPGA. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
2567864|NCT02561806|Secondary|Percentage of Participants With a 100% Improvement of PASI (PASI 100) From Baseline|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week 12|All randomized participants who received at least 1 dose of study drug and had a post-baseline measurement for PASI 100. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
2567894|NCT02561195|Secondary|Percentage of Participants With Treatment Emergent Adverse Events (AEs)||From Vaccination 4 up to 28 days after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
2567866|NCT02561806|Primary|Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week 12|All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline measurement for PASI 90. Participants who did not meet the clinical response criteria or had missing data were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
2567867|NCT02561702|Primary|Number of Participants With a Decrease in Cramp Intensity|Participant will be evaluated for muscle cramps 120 minutes following a single dose of oral mexiletine. The Clinical Evaluator applied pressure to provoke hamstring cramps bilaterally, one at a time 2 hours after dose. The cramp intensity of the right hamstring was reported by the subject on a scale of 1-10 with 1 being weak and 10 being severe.|120 minutes||||participants|||Number
2567868|NCT02561702|Primary|Number of Participants With a Decrease in Cramp Duration|Participant will be evaluated for muscle cramps 120 minutes following a single dose of oral mexiletine. The Clinical Evaluator applied pressure to provoke hamstring cramps bilaterally, one at a time 2 hours after dose. The cramp duration in seconds of the right hamstring was used.|120 minutes||||participants|||Number
2567869|NCT02561585|Secondary|Treatment Satisfaction Questionnaire for Medication Score|"The Treatment Satisfaction Questionnaire for Medication (TSQM II) is a validated, general measure of treatment satisfaction for medication - accounting for effectiveness, side effects, convenience, and global satisfaction - that is comparable across medication types and patient conditions.~The individual derived score for each of the 4 dimensions (effectiveness, side effects, convenience, and global satisfaction) of the TSQM II questionnaire ranged from 0-100, with a higher score indicating greater satisfaction to treatment."|At Week 12 (Day 84)|The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis.|||units on a scale||Standard Deviation|Mean
2567870|NCT02561585|Secondary|Subcategory and Total Score of the Alopecia Areata Quality of Life Questionnaire (AA-QLI)|"The scale includes 21 questions measuring the degree to which the patient was affected by the AA in the last month, scored from 1 (not affected at all) to 4 (highly affected).~The AA-QLI transformed scores for each of the subcategories 'subjective symptoms', 'relationship' and 'objective signs' ranging from (min-max) 9-36, 9-36, and 3-12. Total score ranges from 0-84.~Low score indicating that the participant was least affected by AA."|At baseline (Day 1) and at Week 12 (Day 84)|The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis.|||units on a scale||Standard Deviation|Mean
2567871|NCT02561585|Secondary|Participant's Global Assessment of Hair Regrowth|The participant will assess the hair regrowth before the investigator does any assessments of hair regrowth.|At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)|The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis.|||Participants|||Count of Participants
2567872|NCT02561585|Secondary|Global Assessment of Overall Hair Regrowth Compared to Baseline|Based on standardized photographs|At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)|The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis.|||Participants|||Count of Participants
2567873|NCT02561585|Secondary|Hair Color|Absolute color of hair. Hair color is not applicable for alopecia areata totalis and universalis.|At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)|The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis.|||Participants|||Count of Participants
2567874|NCT02561585|Secondary|Hair Type|Hair type being either vellus hair or terminal hair. Hair type is not applicable for participants with alopecia areata totalis and universalis.|At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)|The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis.|||Participants|||Count of Participants
2567875|NCT02561585|Secondary|Relative Hair Thickness|Thickness relative to participant's normal scalp hair. Relative assessment not applicable for participants with alopecia areata totalis and universalis.|At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)|The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis.|||Participants|||Count of Participants
2567876|NCT02561585|Secondary|Hair Growth Rate|Change in hair length measured in millimeters per day.|At Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)|The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis.|||mm/day||Standard Deviation|Mean
2568202|NCT02556918|Secondary|Mean Post-operative Blood Glucose (BG) Concentration|Mean post-operative blood glucose (BG) concentration during recovery period.|10 days (average time of discharge from the hospital)||||mmol/L||Standard Deviation|Mean
2567879|NCT02561585|Secondary|Summary of Relative Change in SALT Score|The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss.|From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)|The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis.|||percentage change||Standard Deviation|Mean
2567880|NCT02561585|Secondary|Summary of Change in SALT Score|The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss.|From baseline (Day 1) to Week 4 (Day 28), Week 8 (Day 56), and Week 12 (Day 84)|The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis.|||units on a scale||Standard Deviation|Mean
2567881|NCT02561585|Secondary|Summary of Absolute SALT Score|"The SALT (Severity of Alopecia Areata Tool) score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss.~Summary of observed values of the absolute SALT score."|At baseline (Day 1), Week 4 (Day 28), Week 8 (Day 56) and Week 12 (Day 84)|The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants who attended the individual visits where included in the analysis.|||units on a scale||Standard Deviation|Mean
2567882|NCT02561585|Primary|Change in Severity of Alopecia Areata Tool (SALT) Score|The SALT score indicates the sum area of scalp with hair loss and ranges from 0 - 100 (min-max), with higher scores indicating more hair loss. A negative change in SALT score indicates lesser (improvement) hair loss while positive high scores indicate more (worsening) hair loss.|From baseline (Day 1) to Week 12 (Day 84)|The full analysis set (FAS) was defined as all randomized participants who received at least one application of LEO 124249 (20) ointment or LEO 124249 vehicle (11) and had at least one post-baseline efficacy assessment. Only the participants completing Week 12 have been included in the calculation of the change from baseline in the SALT score.|||units on a scale||Standard Deviation|Mean
2567883|NCT02561572|Secondary|Pain Score||24 h postop|Unable to collect data on wards after PACU discharge.||||||
2567884|NCT02561572|Secondary|Pain Score in the Postanaesthetic Care Unit (PACU)|The number of patients experiencing moderate/severe pain in PACU.|Immediately postop||||Participants|||Count of Participants
2567885|NCT02561572|Secondary|Incidence of Postoperative Nausea and Vomiting (PONV)||24 h postop|Unable to collect data on wards after discharge from PACU||||||
2567886|NCT02561572|Secondary|Incidence of Postoperative Nausea and Vomiting (PONV) in the Postanaesthetic Care Unit (PACU)||Within 30 minutes of surgery||||Participants|||Count of Participants
2567887|NCT02561572|Secondary|Amsterdam Preoperative Anxiety and Information Scale Scores|The Amsterdam Pre-operative Anxiety and Information Scale has four questions relating to anxiety (APAISa, Table 2) and has been shown to correlate well with the full version of the State-Trait Anxiety Inventory. The scores from the anxiety elements of the questionnaire are added together giving a possible of total score of 4 (low anxiety) to 20 (high anxiety).|30 minutes after intervention||||units on a scale||Inter-Quartile Range|Median
2567888|NCT02561572|Primary|State-Trait Anxiety Inventory Score|Patients completed the six item short form of the State-Trait Anxiety Inventory (STAI-S6) in order to assess baseline anxiety levels prior to any intervention. The STAI-S6 is a standardised short form of the 40-item Spielberger State-Trait Anxiety Inventory that has three anxiety-present and three anxiety-absent questions (Table 1). Scores from the STAI-S6 are prorated up to allow comparison with the full version of the questionnaire, with scores ranging from 20 (low anxiety) to 80 (high anxiety). The STAI-S6 has been shown to correlate well with the full version, [12] but is much quicker for participants to complete.|30 minutes after intervention||||units on a scale||Inter-Quartile Range|Median
2567889|NCT02561338|Post-Hoc|Change From Baseline in MMTT (Mixed Meal Tolerance Test) β-cell Function Index|Disposition index, i.e DI, by the insulin secretion sensitivity index-2 (ISSI-2). This is an calculated value which represents the ability of a person's pancreatic beta cells to lower blood glucose. A higher number means the pancreas is better able to secrete insulin and improve glucose levels. HOMA IR is an index used to evaluate the individual's insulin resistance level. The HOMA-IR index of normal individuals is 1. With the increase of insulin resistance, HOMA-IR index will be higher than 1.|Baseline and week 12|Both of disposition index and HOMA-IR could reflect the function of β cell.|||units on a scale||Inter-Quartile Range|Median
2567890|NCT02561338|Secondary|Change From Baseline in FPG||Baseline and 12 weeks||||mmol/L||Standard Deviation|Mean
2567891|NCT02561338|Secondary|Change From Baseline in 2hPPG|Using a standard meal tolerance test, to assess 2-h postprandial glucose (2hPPG). In this test, subjects were received meals standardised by China National Cereals, which supplied by Oils and Foodstuffs Corporation and contained 353 kcal, 75 g carbohydrate, 1.48 g fat, and 8.0 g protein. Collect the blood samples to detect blood glucose 2 hours after starting the meal.|Baseline and 12 weeks||||mmol/L||Standard Deviation|Mean
2567892|NCT02561338|Primary|After 12-week Treatment, the Change From Baseline in HbA1c|Assess the percentage of Hemoglobin A1c (HbA1c) changes at week 12. In the group HMS5552 dose3, a subject without follow-up data for HbA1c available was excluded. And in the group HMS5552 dose4, two subjects without follow-up data for HbA1c available were excluded. So the overall number of baseline participants is not consistent with numbers provided in any of the rows in the participant flow module.|Baseline and 12 weeks||||Percentage of glycated hemoglobin||95% Confidence Interval|Least Squares Mean
2567893|NCT02561195|Secondary|Percentage of Participants With Treatment Emergent Serious Adverse Events (SAEs)||From Vaccination 4 up to 6 months after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
2567895|NCT02561195|Secondary|Percentage of Participants With Systemic Events by Severity Within 14 Days of Vaccination 4||within 14 days of Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
2567896|NCT02561195|Secondary|Percentage of Participants With Local Reactions by Severity Within 14 Days of Vaccination 4||within 14 days of Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
2567897|NCT02561195|Secondary|Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 8, 30, Month 6, 12, 18, 24, 30 and 36||Day 8, 30 and Month 6, 12, 18, 24, 30, 36|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
2567898|NCT02561195|Secondary|Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 30, Month 6, 12, 18, 24, 30 and 36||Day 8, 30 and Month 6, 12, 18, 24, 30, 36|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
2567899|NCT02561195|Secondary|Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 30 and Month 6, 12, 18, 24, 30, 36||Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
2567900|NCT02561195|Secondary|Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Month 6, 12, 18, 24, 30, 36||Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
2567901|NCT02561195|Secondary|Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Month 6, 12, 18, 24, 30, 36||Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
2567902|NCT02561195|Secondary|Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Day 8, 30 and Month 6, 12, 18, 24, 30, 36||day 8, 30; month 6, 12, 18, 24, 30, 36 after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
2567903|NCT02561195|Secondary|Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Day 8, 30 and Month 6, 12, 18, 24, 30, 36||Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
2567904|NCT02561195|Secondary|Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 8, 30 and Month 6, 12, 18, 24, 30, 36||Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
2567905|NCT02561195|Secondary|Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 8, 30 and Month 6, 12, 18, 24, 30, 36||Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
2567906|NCT02561195|Secondary|Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 8, 30 and Month 6, 12, 18, 24, 30, 36||Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4|The data for the immunogenicity at Day 8, 30 and Month 6, 12, 18, 24, 30, 36 after Vaccination 4 and safety outcome measures after Vaccination 4 are not available at primary completion date and will be posted once the study completion date is achieved.||||||
2567907|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18|Toxin A and toxin B antibodies were measured using neutralization assay.|Day 30, 37, 187 and Month 2, 6, 7, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2567908|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18|Toxin A antibodies were measured using neutralization assay.|Day 30, 37, 187 and Month 2, 6, 7, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2567999|NCT02560493|Secondary|Changes in Diastolic Blood Pressure|Resting blood pressure will be assessed at Screening, Week 0, and Week 24 using standard clinical procedures on a standard mercury manometer. The participant's age-, sex-, and height-specific percentile will be calculated.|Change between Baseline (Week 0) and 6 months (Week 24)|One participant was lost to follow-up.|||percentile||Standard Error|Least Squares Mean
2567909|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18|Toxin A antibodies were measured using neutralization assay.|Day 30, 37, 187 and Month 2, 6, 7, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2567910|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13|Toxin A and toxin B antibodies were measured using neutralization assay.|Day 8, 15, 30, 37 and Month 2, 4, 7, 13|Evaluable immunogenicity population: All eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations. N= number of participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2567911|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13|Toxin B antibodies were measured using neutralization assay.|Day 8, 15, 30, 37 and Month 2, 4, 7, 13|Evaluable immunogenicity population: All eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations. N= number of participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2567912|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13|Toxin A antibodies were measured using neutralization assay.|Day 8, 15, 30, 37 and Month 2, 4, 7, 13|Evaluable immunogenicity population: All eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations. N= number of participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2567913|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18|GMFR for toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Day 30, 37, 187 and Month 2, 6, 7, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||fold rise||95% Confidence Interval|Geometric Mean
2567914|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18|GMFR in toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Day 30, 37, 187 and Month 2, 6, 7, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||fold rise||95% Confidence Interval|Geometric Mean
2567915|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13|GMFR in toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Day 8, 15, 30, 37 and Month 2, 4, 7, 13|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations. Here, N= number of participants evaluable for this outcome measure.|||fold rise||95% Confidence Interval|Geometric Mean
2567916|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13|Geometric mean fold rise (GMFR) in toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.|Day 8, 15, 30, 37 and Month 2, 4, 7, 13|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.|||fold rise||95% Confidence Interval|Geometric Mean
2567917|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18|GMC of toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations.|Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||neutralization units/mL||95% Confidence Interval|Geometric Mean
2567955|NCT02561156|Secondary|Part 2: Cmax,ss: Maximum Observed Plasma Concentration at Steady State for TAK-653||Day 18 pre-dose and at multiple time points (up to 24 hours) post dose|The PK analysis set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in urine. The PK analysis population where data at specified time points was available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2567918|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18|GMC of toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations.|Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||neutralization units/mL||95% Confidence Interval|Geometric Mean
2567919|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13|GMC of toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations.|Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.|||neutralization units/mL||95% Confidence Interval|Geometric Mean
2567920|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13|Geometric mean concentration (GMC) of toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. Confidence interval (CI) for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations.|Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.|||neutralization units/mL||95% Confidence Interval|Geometric Mean
2567921|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18|Toxin A and toxin B antibodies were measured using neutralization assay.|Day 1, 30, 37, 187 and Month 2, 6, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2567922|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18|Toxin B antibodies were measured using neutralization assay.|Day 1, 30, 37, 187 and Month 2, 6, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2567923|NCT02561195|Secondary|Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18|Toxin A antibodies were measured using neutralization assay.|Day 1, 30, 37, 187 and Month 2, 6, 12, 18|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2567924|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13|Toxin A and toxin B antibodies were measured using neutralization assay.|Day 1, 8, 15, 30 and Month 2, 4, 7, 13|Evaluable immunogenicity population: All eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations. N= number of participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2567925|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13|Toxin B antibodies were measured using neutralization assay.|Day 1, 8, 15, 30 and Month 2, 4, 7, 13|Evaluable immunogenicity population: All eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations. N= number of participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2567926|NCT02561195|Secondary|Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13|Toxin A antibodies were measured using neutralization assay.|Day 1, 8, 15, 30 and Month 2, 4, 7, 13|Evaluable immunogenicity population: All eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2567927|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants With Treatment Emergent Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. Treatment-emergent serious adverse events are events between first dose of study drug and up to 6 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.|From Vaccination 1 up to 6 months after Vaccination 3 (Month 12)|Safety population: all participants who received at least 1 dose of the investigational product.|||percentage of participants|||Number
2567928|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants With Treatment Emergent Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. Treatment-emergent serious adverse events are events between first dose of study drug and up to 6 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.|From Vaccination 1 up to 6 months after Vaccination 3 (Month 7)|Safety population: all participants who received at least 1 dose of the investigational product.|||percentage of participants|||Number
2567929|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants With Treatment Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.|From Vaccination 1 up to 28 days after Vaccination 3 (Day 208)|Safety population: all participants who received at least 1 dose of the investigational product.|||percentage of participants|||Number
2567930|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants With Treatment Emergent Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.|From Vaccination 1 up to 28 days after Vaccination 3 (Day 58)|Safety population: all participants who received at least 1 dose of the investigational product.|||percentage of participants|||Number
2567931|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3|Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).|within 14 days after Vaccination 3|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
2567932|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3|Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).|within 14 days after Vaccination 3|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
2567933|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2|Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).|within 14 days after Vaccination 2|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
2567934|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2|Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).|within 14 days after Vaccination 2|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
2571687|NCT02513732|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|0 to 3 years|ITT population|||Participants|||Count of Participants
2567935|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1|Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).|within 14 days after Vaccination 1|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
2567936|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1|Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 degree Celsius (C)), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).|within 7 days after Vaccination 1|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
2567937|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3|Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and grade 4 (necrosis).|within 14 days after Vaccination 3|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
2567938|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3|Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and grade 4 (necrosis).|within 14 days after Vaccination 3|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
2567939|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2|Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and grade 4 (necrosis).|within 14 days after Vaccination 2|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
2567940|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2|Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and grade 4 (necrosis).|within 14 days After Vaccination 2|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
2567941|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1|Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and grade 4 (necrosis).|within 14 days After Vaccination 1|"Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
2567942|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1|Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (grade 1) (did not interfere with activity), moderate (grade 2)(interfered with activity), severe (grade 3) (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 centimeter [cm]), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and grade 4 (necrosis).|within 7 days After Vaccination 1|"Safety population: all participants who received at least 1 dose of the investigational product. Here N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
2567943|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Month 7|Toxin A and toxin B antibodies were measured using neutralization assay.|Month 7 (1 month after Vaccination 3 of Month 0, 1 and 6 regimen)|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2567944|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 37|Toxin A and toxin B antibodies were measured using neutralization assay.|Day 37 (7 days after Vaccination 3 of Day 1, 8 and 30 regimen)|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2567945|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Month 7|Toxin B antibodies were measured using neutralization assay.|Month 7 (1 month after Vaccination 3 of Month 0, 1 and 6 regimen)|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2567946|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 37|Toxin B antibodies were measured using neutralization assay.|Day 37 (7 days after Vaccination 3 of Day 1, 8 and 30 regimen)|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2567947|NCT02561195|Primary|Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Month 7|Toxin A antibodies were measured using neutralization assay.|Month 7 (1 month after Vaccination 3 of Month 0, 1 and 6 regimen)|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2567948|NCT02561195|Primary|Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 37|Toxin A antibodies were measured using neutralization assay.|Day 37 (7 days after Vaccination 3 of Day 1, 8 and 30 regimen)|Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2567949|NCT02561156|Primary|Part 2: Number of Participants With Treatment-emergent Suicidal Ideation or Suicidal Behavior as Measured Using C-SSRS|Treatment-emergent suicidal ideation or behavior compared to baseline will be measured by an increase in suicidal ideation category (1-5 on the C-SSRS) or suicidal behavior category (6-10 on the C-SSRS) during treatment from the maximum suicidal ideation/behavior category at baseline, or any suicidal ideation/behavior during treatment if there is none at baseline. C-SSRS is used to assess whether participant experienced suicidal ideation (1: wish to be dead; 2: non-specific active suicidal thoughts; 3: active suicidal ideation with any methods (not plan) without intent to act; 4: active suicidal ideation with some intent to act, without specific plan; 5: active suicidal ideation with specific plan and intent) and suicidal behavior (6: actual attempt; 7: interrupted attempt; 8: aborted attempt; 9: preparatory acts or behavior; 10: suicidal behavior).|Baseline up to Day 21|The safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2567950|NCT02561156|Secondary|Part 2: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-653||Days 6 and 18 pre-dose and at multiple timepoints (up to 24 hours) post-dose|The PK analysis set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in urine. The PK analysis population where data at specified time points was available.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2567951|NCT02561156|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-653||Part 1 Cohort 1-5: Day 1 pre-dose and at multiple timepoints (up to 144 hours) post-dose; Part 1 Cohort 6: Day 1 pre-dose and at multiple timepoints (up to 168 hours) post-dose; Part 2: Day 1 pre-dose and at multiple timepoints up to 120 hours) post-dose|The PK analysis set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in urine.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2567952|NCT02561156|Secondary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-653||Part 1 Cohort 1-5: Day 1 pre-dose and at multiple timepoints (up to 144 hours) post-dose; Part 1 Cohort 6: Day 1 pre-dose and at multiple timepoints (up to 168 hours) post-dose; Part 2: Day 1 pre-dose and at multiple timepoints up to 120 hours) post-dose|The PK analysis set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in urine.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2567953|NCT02561156|Secondary|Part 2: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-653 on Day 18||Day 18 pre-dose and at multiple time points (up to 24 hours) post dose|The PK analysis set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in urine. The PK analysis population where data at specified time points was available.|||hours||Full Range|Median
2567954|NCT02561156|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-653 on Day 1||Part 1 Cohort 1-5: Day 1 pre-dose and at multiple timepoints (up to 144 hours) post-dose; Part 1 Cohort 6: Day 1 pre-dose and at multiple timepoints (up to 168 hours) post-dose; Part 2: Day 1 pre-dose and at multiple timepoints up to 120 hours) post-dose|The PK analysis set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in urine.|||hours||Full Range|Median
2567957|NCT02561156|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-653 on Day 1||Part 1 Cohort 1-5: Day 1 pre-dose and at multiple timepoints (up to 144 hours) post-dose; Part 1 Cohort 6: Day 1 pre-dose and at multiple timepoints (up to 168 hours) post-dose; Part 2: Day 1 pre-dose and at multiple timepoints (up to 120 hours) post-dose|The pharmacokinetics (PK) analysis set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in urine.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2567958|NCT02561156|Primary|Part 1: Number of Participants With Treatment-emergent Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)|Treatment-emergent suicidal ideation or behavior compared to baseline will be measured by an increase in suicidal ideation category (1-5 on the C-SSRS) or suicidal behavior category (6-10 on the C-SSRS) during treatment from the maximum suicidal ideation/behavior category at baseline, or any suicidal ideation/behavior during treatment if there is none at baseline. C-SSRS is used to assess whether participant experienced suicidal ideation (1: wish to be dead; 2: non-specific active suicidal thoughts; 3: active suicidal ideation with any methods (not plan) without intent to act; 4: active suicidal ideation with some intent to act, without specific plan; 5: active suicidal ideation with specific plan and intent) and suicidal behavior (6: actual attempt; 7: interrupted attempt; 8: aborted attempt; 9: preparatory acts or behavior; 10: suicidal behavior).|Cohort 1-5: Baseline up to Day 7; Cohort 6: Baseline up to Day 8|The safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2567959|NCT02561156|Primary|Part 2: Percentage of Participants Who Experience Clinically Significant Abnormal Changes in Safety EEG Measurements at Least Once Postdose||Baseline up to Day 18|The safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2567960|NCT02561156|Primary|Part 1: Percentage of Participants Who Experience Clinically Significant Abnormal Changes in Safety Electroencephalogram (EEG) Measurements at Least Once Postdose||Cohort 1-5: Baseline up to Day 7; Cohort 6: Baseline up to Day 8|The safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2567961|NCT02561156|Primary|Part 2: Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety ECG at Least Once Postdose||Baseline up to Day 8|The safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2567962|NCT02561156|Primary|Part 1: Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) at Least Once Postdose||Cohort 1-5: Baseline up to Day 7; Cohort 6: Baseline up to Day 8|The safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2567963|NCT02561156|Primary|Part 2: Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Postdose||Baseline up to Day 21|The safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2567964|NCT02561156|Primary|Part 1: Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Postdose||Cohort 1-5: Baseline up to Day 7; Cohort 6: Baseline up to Day 8|The safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2567965|NCT02561156|Primary|Part 2: Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Postdose||Baseline up to Day 8|The safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2567966|NCT02561156|Primary|Part 1: Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Postdose||Cohort 1-5: Baseline up to Day 7; Cohort 6: Baseline up to Day 8|The safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2567967|NCT02561156|Primary|Part 2: Percentage of Participants Who Discontinued the Treatment Due to an AE||Baseline up to Day 31|The safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2567968|NCT02561156|Primary|Part 1: Percentage of Participants Who Discontinued the Treatment Due to an Adverse Event (AE)||Baseline up to Day 14|The safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2567969|NCT02561156|Primary|Part 2: Percentage of Participants Who Experience at Least One TEAE||Baseline up to Day 31|The safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2567970|NCT02561156|Primary|Part 1: Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)||Baseline up to Day 14|The safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2567971|NCT02560922|Secondary|Patient Global Impression of Arthritis Symptom Change From Baseline (BL) at 3 and 9 Months|"This measure asks participants to describe their change in pain on a 7-point rating scale with the following options: very much improved, much improved, minimally improved, no change, minimally worse, much worse, and very much worse. The total range is 0-7, with lower scores indicating more improvement."|Baseline, 3 months and 9 months|All randomized participants|||units on a scale||95% Confidence Interval|Mean
2567972|NCT02560922|Secondary|Change From Baseline to Month 3 and Change From Baseline to 9 Month in Arthritis Self-Efficacy Scale|This scale includes 8 items asking respondents how certain they are that they can manage arthritis pain and keep it from interfering with specific activities All items are scored on a scale of 1 (very uncertain) to 10 (very certain), with higher scores indicating greater self-efficacy for managing arthritis symptoms.|Baseline, 3 months and 9 months|All randomized participants|||units on a scale||95% Confidence Interval|Mean
2567973|NCT02560922|Secondary|Change From Baseline to Month 3 and Change From Baseline to 9 Month in Patient Health Questionnaire 8 (PHQ-8)|This 8-item survey of depressive symptoms includes items corresponding to the depression criteria listed in the Diagnostic and Statistics Manual Fourth Edition (DSM-IV) [38]. All items are scored as 0 (not at all) to 3 (nearly every day), with higher scores indicating more depressive symptoms.|Baseline, 3 months and 9 months|All randomized participants|||units on a scale||95% Confidence Interval|Mean
2567974|NCT02560922|Secondary|Change From Baseline to Month 3 and Change From Baseline to 9 Month in Coping Strategies Questionnaire (CSQ)|"This scale includes 48 items that assess 6 cognitive domains (Catastrophizing, Diverting Attention, Ignoring Sensations, Coping Self-Statements, Reinterpreting Pain Sensations, Praying-Hoping) and 1 behavioral domain (Increasing Behavioral Activities). Each domain includes 6 items, and participants rate the frequency of their use of specific coping strategies on a 7-point Likert scale from 0 (Never do that) to 6 (Always do that). A Total Coping Attempts score was created, which includes 5 cognitive domains and 1 behavioral domain but excludes the Catastrophizing domain, similar to prior studies. Total range is 252, with higher scores indicating more coping attempts."|Baseline, 3 months, 9 months|All randomized participants|||units on a scale||95% Confidence Interval|Mean
2567975|NCT02560922|Secondary|Change From Baseline to Month 3 and Change From Baseline to 9 Month in SF-12 Mental Component Health Score|This 12-item measure covers domains of general health, physical health, work and activity limitations, and emotional health. Mental Health and Physical Health Composite Scores were computed, both of which range from 0-100 with lower scores indicating poorer health.|Baseline, 3 months and 9 months|This variable was analyzed as a change score (baseline to 3-month and baseline to 9-month), due to normality assumptions. Therefore only participants with complete data at baseline and follow-up could be included in the analysis, resulting in a smaller sample than the total population.|||units on a scale||95% Confidence Interval|Mean
2567976|NCT02560922|Secondary|Change From Baseline to Month 3 and Change From Baseline to 9 Month in Short Form (SF)-12 Physical Component Health Score|This 12-item measure covers domains of general health, physical health, work and activity limitations, and emotional health. Mental Health and Physical Health Composite Scores were computed, both of which range from 0-100 with lower scores indicating poorer health.|Baseline, 3 months and 9 months|All randomized participants|||units on a scale||95% Confidence Interval|Mean
2567977|NCT02560922|Secondary|Change From Baseline to Month 3 and Change From Baseline to 9 Month in PROMIS Pain Interference (Short Form 6a)|The PROMIS Pain Interference (Short Form 6a) instrument measures the self-reported consequences of pain across aspects of life including social, cognitive, emotional, physical and recreational activities; this instrument refers to the past seven days. This validated scale has five response options, with scores ranging from one to five. Scores are converted to t-scores, and higher scores indicate greater pain interference.|Baseline, 3 months and 9 months|All randomized participants|||t-score||95% Confidence Interval|Mean
2567978|NCT02560922|Secondary|Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Function Subscale|In addition to the pain subscale, the WOMAC includes stiffness (2 items) and function (17 items) subscales. All items are listed rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms), with ranges of 0-68 for the function subscale, with higher scores indicating worse symptoms and function.|Baseline, 3 months and 9 months|All randomized participants|||units on a scale||95% Confidence Interval|Mean
2567979|NCT02560922|Secondary|Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Total Score|In addition to the pain subscale, the WOMAC includes stiffness (2 items) and function (17 items) subscales. All items are listed rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms), with ranges of 0-96 for the total score (pain, stiffness, and function subscales), with higher scores indicating worse symptoms and function.|Baseline, 3 months and 9 months|All randomized participants|||units on a scale||95% Confidence Interval|Mean
2567980|NCT02560922|Primary|Change From Baseline to Month 3 and Change From Baseline to 9 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale|Change over time in the primary outcome measure for this study, the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Pain Subscale is a measure of lower extremity pain. It includes 5 items rated on a Likert scale of 0 (no symptoms) to 4 (extreme symptoms), with a total range of 0-20 with higher scores indicating worse symptoms and function.|Baseline, 3 months and 9 months|All randomized participants|||units on a scale||95% Confidence Interval|Mean
2567981|NCT02560753|Other Pre-specified|Safety and Tolerability of Treatment With T3D-959 Over a 2-week Period in Subjects With Mild-to-moderate AD. New|Number of participants with treatment related adverse events (AEs) as assessed by analysis of adverse events, including symptoms, and abnormal findings on physical and neurological examinations, and standard labs.|after 14 days of treatment|3 mg group:A subject Dc'd prior to the EOT & another subject became uncooperative at EOT and refused to take the DSST. Her results for EOT were missing. 30 mg: A subject DC'd prior to EOT, another subject was described as being very agitated at the EOT. The results presented omitted this subject’s EOT data.|||participants|||Number
2567982|NCT02560753|Secondary|Change From Baseline in the Total Score of the 11-item Alzheimer's Disease Assessment Scale - Cognitive Subscale|The 11-item Alzheimer's Disease Assessment Scale (ADAS-Cog 11) is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis. The score can range between 0 and 70. A higher score indicates more cognitive impairment. A positive change in the score indicates cognitive worsening. The minimum severity score is 0 and the maximum severity score is 70.|after 14 days of treatment|3 mg group:A subject Dc'd prior to the EOT & another subject became uncooperative at EOT and refused to take the DSST. Her results for EOT were missing. 30 mg: A subject DC'd prior to EOT, another subject was described as being very agitated at the EOT. The results presented omitted this subject’s EOT data.|||score on a scale||Standard Deviation|Mean
2567983|NCT02560753|Secondary|Change From Baseline in the Score of the Digit Symbol Substitution Test|The digit symbol substitution test assesses attention, psychomotor speed, complex scanning, visual tracking, and immediate memory. This test consists of 4 rows each with 25 small blank squares; above each square is a number between 1 and 9. At the top is a 'key,' which pairs each number (1 through 9) with an unfamiliar symbol. The participant has 90 seconds to work as quickly as possible (left to right across the rows) to fill in each blank square with the appropriate symbol based on the number above the square. Results are presented as total number correct; therefore, lower numbers indicate greater impairment. Scores on the DSST range from 0-93.|after 14 days of treatment|3 mg group:A subject Dc'd prior to the EOT & another subject became uncooperative at EOT and refused to take the DSST. Her results for EOT were missing. 30 mg: A subject DC'd prior to EOT, another subject was described as being very agitated at the EOT. The results presented omitted this subject’s EOT data.|||score on a scale||Standard Deviation|Mean
2567984|NCT02560753|Primary|The Effect of Treatment With T3D-959 on Changes in Resting State Blood Oxygen Level Dependent (BOLD) Signal in Functional Magnetic Resonance Imaging (fMRI) of the Brain Areas Associated With Cognitive Tasks.|Changes in BOLD fMRI parameters such as GoF (see Study Description) over the course of two weeks of treatment, were obtained in this study. BOLD fMRI has been used in cross sectional and longitudinal studies of Alzheimer's subjects, for instance in the Alzheimer's Disease Neuroimaging Initiative studies. However, no studies monitoring Default Mode Networks measured parameters such as GoF, in the context of an effective AD therapeutic, as a result it is difficult to interpret the observed small changes listed in BOLD fMRI parameters obtained in this trial. Instead the changes in the listed BOLD fMRI parameters (EOT - BL) are reported without interpretation. These values represent changes in fMRI connectivity patterns over time and are unitless.|after 14 days of treatment||||unitless||Standard Deviation|Mean
2567985|NCT02560753|Primary|Change From Baseline (End of Treatment - Baseline) for FDG-PET Imaging With Whole Brain and White Matter as Reference Region|"Changes in relative brain glucose metabolism (delta R CMRgl) were measured by FDG-PET. At each time point, a ratio of the PET reading in a pre-defined region of interest (sROI), known to be affected by AD, and in a reference region (RR) that is spared in AD, is determined. This ratio is defined as sROI index (spared region). A second RR, brain white matter (WM), was also used in this calculation: sROI index (WM) value. delta sROI is defined as change in the sROI index values, over the treatment period. In this study we are looking for changes in delta sROI with increasing doses of T3D-959. Dose dependent changes in delta sROI (AD spared) are compared to those observed with the WM as the RR: delta sROI (WM). Dose related changes in delta sROI suggests T3D-959 is entering the brain and effecting glucose metabolism in a dose dependent fashion."|after 14 days of treatment|Both + & - values for delta sROI represent “better outcomes” with regard to the demonstrating pharmacological activity of a PPAR delta, such as T3D-959, in the brain. It is unknown at this time, both from this presented data and from the literature, whether the pharmacological action of a PPAR delta agonist will translate to better outcomes in AD.|||ratio||Standard Deviation|Mean
2567986|NCT02560701|Secondary|Medication Adherence for Bipolar Disorder - Psychotropic Medications|Mean number of annual psychotropic medication fills in the follow-up period among bipolar patients|YEAR 2||||medication fills per year||Standard Deviation|Mean
2567987|NCT02560701|Other Pre-specified|Annual Patient Out-of-pocket Costs for Patients With Bipolar Disorder|Annual patient out-of-pocket costs (paid deductible, coinsurance, and copayment amounts) for patients with Bipolar Disorder in the baseline period|YEAR 2, YEAR 3||||U.S. Dollars per year||Standard Deviation|Mean
2567988|NCT02560701|Secondary|Access To Outpatient Services for Bipolar Disorder|Mean number of annual outpatient mental health visits for bipolar patients, averaged across baseline and follow-up periods|YEAR 2||||visits per year||Standard Deviation|Mean
2567989|NCT02560701|Primary|Medication Adherence for Bipolar Disorder|Mean number of annual bipolar medication fills in the follow-up period among bipolar patients|YEAR 2||||Medication fills per year||Standard Deviation|Mean
2567990|NCT02560701|Primary|Emergency Department Visits Among Patients With Bipolar Disorder|Mean number of annual emergency department visits in the follow-up period among bipolar patients|Year 3||||ED visits per year||Standard Deviation|Mean
2567991|NCT02560701|Primary|Inpatient Hospitalizations Among Bipolar Patients|Mean number of annual inpatient hospitalizations in the follow-up period among bipolar patients|Year 3||||hospitalizations per year||Standard Deviation|Mean
2567992|NCT02560584|Secondary|Proportion of Patients With One or More Carcinoma in Situ (CIS) Lesions Detected With Blue Light Cystoscopy With Cysview and None With White Light Cystoscopy|In the subsection of patients with histologically confirmed CIS, the proportion of patients detected only by blue light cystoscopy with Cysview is measured.|At time of cystoscopy procedure|Number of patients with histologically confirmed CIS|||Participants|||Count of Participants
2567993|NCT02560584|Secondary|Proportion of Patients With Adverse Events Considered Causally Related to Cysview and/or Blue Light in the Surveillance Examination Compared With the OR Examination||At time of cystoscopy procedure|This is a within patient control trial, where the white light (WL) cystoscopy was the comparator. Enrolled participants received a WL and blue light (BL) surveillance examination after Cysview instillation. Operating room (OR) cystoscopy in WL and BL was performed for patients with suspicion of recurrence after surveillance cystoscopy.|||Participants|||Count of Participants
2567994|NCT02560584|Primary|Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy|In the subsection of patients with histologically confirmed malignancy, the proportion of patients detected only by the use of blue light cystoscopy with Cysview is measured.|At time of cystoscopy procedure|Patients with histologically confirmed malignancy|||Participants|||Count of Participants
2567995|NCT02560493|Secondary|Changes in Diet|Dietary information will be collected from the participant at Week 0 and Week 24. Healthy diet score will be determined by the NCI Self-administered 24-hour Dietary Recall (ASA24-Kids). This survey is administered on a computer through a web-based program.|Change between Baseline (Week 0) and 6 months (Week 24)|Some participants did not complete the dietary recalls.|||kcal/day||Standard Error|Least Squares Mean
2567996|NCT02560493|Secondary|Changes in Physical Activity|Physical activity will be assessed with an Actigraph GT3X+ accelerometer (ActiGraph, of Ft. Walton Beach, FL) to determine changes in habitual physical activity outside of the gaming intervention. Participants will wear the accelerometer for two bouts of 7-days following Week 0 baseline clinic visit and Week 24 clinic visit, but not during the gaming intervention.|Change between Baseline (Week 0) and 6 months (Week 24)|Several participants did not meet criteria for complete accelerometry data (at least 4 days of 10 hours/day including 1 weekend day) at both time points.|||minutes/day||Standard Error|Least Squares Mean
2567997|NCT02560493|Secondary|Changes in Fasting Glucose|A blood sample will be taken at Week 0 and Week 24 by a trained phlebotomist following standard clinic procedures after an 8-hour fast. Serum concentrations of glucose will be obtained from a DXC600 by Beckman Coulter.|Change between Baseline (Week 0) and 6 months (Week 24)|One participant was lost to follow-up.|||mg/dL||Standard Error|Least Squares Mean
2567998|NCT02560493|Secondary|Changes in Total Cholesterol|A blood sample will be taken at Week 0 and Week 24 by a trained phlebotomist following standard clinic procedures after an 8-hour fast. Serum concentrations of total cholesterol will be assayed on a DXC600 from Trinity.|Change between Baseline (Week 0) and 6 months (Week 24)|One participant was lost to follow-up.|||mg/dL||Standard Error|Least Squares Mean
2568000|NCT02560493|Secondary|Changes in Systolic Blood Pressure|Resting blood pressure will be assessed at Screening, Week 0, and Week 24 using standard clinical procedures on a standard mercury manometer. The participant's age-, sex-, and height-specific percentile will be calculated.|Change between Baseline (Week 0) and 6 months (Week 24)|One participant was lost to follow-up.|||percentile||Standard Error|Least Squares Mean
2568001|NCT02560493|Secondary|Changes in Body Fat|A dual energy x-ray absorptiometry (DXA) scan will be completed at Week 0 and Week 24 with a GE iDXA whole-body scanner (GE Medical Systems, Milwaukee, WI) to measure adiposity, including total body fat mass and regional fat mass in the extremities and trunk.|Change between Baseline (Week 0) and 6 months (Week 24)|One participant was lost to follow-up.|||kg||Standard Error|Least Squares Mean
2568002|NCT02560493|Primary|Changes in Body Mass Index Z-score (BMIz) Compared to a Control Group|Height and weight will be collected at Screening, Week 0, and Week 24. Standing height will be measured in cm with a Harpenden stadiometer (Holtain Limited, Crymych, UK) with shoes removed while the participant holds breath and an assessor applies light traction to align the participant's head along the Frankfort Horizontal Plane. Weight will be measured in kg with a Michelli GSE 460 scale (G.T. Michelli Co., Baton Rouge, LA) while wearing a hospital gown and undergarments. Measures will be taken twice and recorded to the nearest 0.1 units, with a third if the initial 2 measures are greater than 0.5 units apart. BMIz will be calculated based on the child's age, sex, height, and weight using the 2000 Centers for Disease Control and Prevention (CDC) Growth Charts. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean|Change between Baseline (Week 0) and 6 months (Week 24)|One participant was lost to follow-up.|||z-score||Standard Error|Least Squares Mean
2568003|NCT02560389|Secondary|Functional Activation of Anterior Cingulate Cortex|Differential functional activation of the anterior cingulate cortex will be assessed with respect to the conditioned stimulus versus the control stimulus. The investigators will compare, at an aggregate level, the differential functional activation between the placebo, 100 mg, and 200 mg L-DOPA groups.|Within 30 days of the MRI|"Data was excluded for following number of participants due to artifacts caused by excessive head motion during the scan.~Placebo n=4 participants, 100mg L-DOPA n=3 participants, 200mg L-DOPA n=3 participants"|||percentage change||Standard Error|Mean
2568004|NCT02560389|Secondary|Percentage Change in Functional Activation of Amygdala|"Amygdala is the part of the brain which controls emotions, survival instincts, and memory. PTSD patients exhibit hyperactivity in the amygdala in response to stimuli.~Differential functional activation of the amygdala will be assessed with respect to the conditioned stimulus versus the control stimulus. The investigators will compare, at an aggregate level, the differential functional activation between the placebo, 100 mg, and 200 mg L-DOPA groups."|Within 30 days of the MRI|"fMRI data was excluded for following number of participants due to artifacts caused by excessive head motion during the scan.~Placebo n=4 participants, 100mg L-DOPA n=3 participants, 200mg L-DOPA n=3 participants"|||Percentage change||Standard Deviation|Mean
2568005|NCT02560389|Primary|Galvanic Skin Response|Differential galvanic skin response will be assessed with respect to the conditioned stimulus versus the control stimulus. The investigators will compare, at an aggregate level, the differential galvanic skin response between the placebo, 100 mg, and 200 mg L-DOPA groups.|Within 30 days of the MRI||||Unitless||Standard Deviation|Mean
2568006|NCT02560324|Secondary|Side Effects of Ramelteon|Side effects will be assessed at each in-person visit using a Side Effects Checklist (SEC) that lists 21 possible side effects of ramelteon. The scale for rating each side effect is None=0, Mild=1, Moderate=2, and Severe=3. The higher the score, the more side effects reported by the participant. The minimum score is 0 and the maximum score is 3 for each possible item on the scale. The Outcome Measure is an average of the 21 listed side effects.|Baseline (weeks 1 and 5); Quit assessments (weeks 2 and 6)||||scores on a scale||Standard Deviation|Mean
2568007|NCT02560324|Secondary|Objective Sleep Disturbance|Sleep efficiency (% of time in bed spent sleeping) will be assessed via the SensewearPro armbands during each quit assessment.|Week 2 and Week 6||||% of time in bed spent sleeping||Standard Deviation|Mean
2568008|NCT02560324|Secondary|Subjective Sleep Disturbance|Sleep onset latency will be assessed via daily sleep diaries during each quit assessment.|Week 2 and Week 6||||minutes||Standard Deviation|Mean
2568009|NCT02560324|Primary|Total Number of Smoke-free Days (Biochemically Verified) During Each 5-day Quit Assessment.|The quit assessment will begin the Monday morning of each quit week and will end that Friday. The total number of days of abstinence will be assessed.|Week 2 and Week 6||||days of smoking abstinence||Standard Deviation|Mean
2568010|NCT02560051|Secondary|Safety of Drug Regimen as Measured by Number of Adverse Events||From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 10 months||||adverse event|||Number
2568011|NCT02560051|Secondary|Quality of Life Measure by FACT-P Scale|"The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.~The time point is about 12 weeks after completion of the last cycle. For the arm completing 3 cycles, the time point is 36 weeks after treatment initiation. For the arm completing 4 cycles, the time point is 44 weeks after treatment initiation. For the arm completing 5 cycles, the time point is 52 weeks after treatment initiation."|about 12 weeks after completion of the last cycle|Fewer were analyzed than the number that started study because some participants were taken off study at different points in treatment or follow-up because of adverse events, progression, and withdrawal from study.|||units on a scale||Full Range|Median
2568053|NCT02559622|Secondary|Change From Baseline in Sex Hormone-binding Globulin (SHBG) at Week 4, 12, 24 and 52|Sex hormone-binding globulin (SHBG), a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for SHBG of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively."|||nanomole per Liter (nmol/L)||95% Confidence Interval|Mean
2568012|NCT02560051|Secondary|Quality of Life Measure by FACT-P Scale|The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.|post cycle 5, which is about about 40 weeks after treatment initiation|This time point is after 5 cycles of chemo so so no participants in the groups that had only 3/4 cycles were included. For the other group fewer were analyzed than the number that started study because for some treatment was prematurely stopped at different points in treatment because of adverse events, progression, and withdrawal from study.|||units on a scale||Full Range|Median
2568013|NCT02560051|Secondary|Quality of Life Measure by FACT-P Scale|The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.|post cycle 4, which is about 32 weeks after treatment initiation|"This is after 4 cycles of chemo so no one in group definitive local therapy were analyzed. For the other groups fewer were analyzed than the number that started study because for some participants treatment or follow-up was prematurely stopped at different points because of adverse events, progression, and withdrawal from study."|||units on a scale||Full Range|Median
2568014|NCT02560051|Secondary|Quality of Life Measure by FACT-P Scale|The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.|post cycle 3, which is about 24 weeks after treatment initiation|Fewer were analyzed than the number that started study because some participants were taken off study at different points throughout the study because of adverse events, progression, and participant withdrawal from study. Additionally, some participants did not wish to complete the FACT-P questionnaire.|||units on a scale||Full Range|Median
2568015|NCT02560051|Secondary|Quality of Life Measure by FACT-P Scale|The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.|post cycle 2, which is about 16 weeks after treatment initiation|Fewer were analyzed than the number that started study because not all participants completed the full number of cycles of treatment assigned. For some participants treatment was prematurely discontinued at different points through the course of treatment because of adverse events, progression, and participant withdrawal from study.|||units on a scale||Full Range|Median
2568016|NCT02560051|Secondary|Quality of Life Measure by FACT-P Scale|The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale is a tool used for assessing the health-related quality of life (QoL) in men with prostate cancer. It consists of 27 core items which assess patient function in four domains (Physical, Social/Family, Emotional, and Functional well-being), and it is further supplemented by 12 site specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert type scale, and then combined to produce a global QoL score, with a range of scores of 0 to 156. Higher scores represent better QoL.|post cycle 1, which is about 8 weeks after treatment initiation||||units on a scale||Full Range|Median
2568017|NCT02560051|Secondary|Efficacy as Measured by Number Who PSA Progressed|PSA progression defined as increase in Prostate Specific Antigen (PSA) >0.3 ng/mL over 2 measurements|From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 10 months||||Participants|||Count of Participants
2568018|NCT02560051|Secondary|Efficacy as Measured by PSA Level|"Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.~The time point is the end of treatment, which is about about 8 weeks after the start of the last cycle. For the arm completing 3 cycles, the time point is 24 weeks after treatment initiation. For the arm completing 4 cycles, the time point is 32 weeks after treatment initiation. For the arm completing 5 cycles, the time point is 40 weeks after treatment initiation."|end of treatment, which is about about 8 weeks after the start of the last cycle|Fewer were analyzed than the number that started study because some participants were taken off study at different points in treatment or follow-up because of adverse events, progression, and withdrawal from study.|||ng/mL||Full Range|Median
2568019|NCT02560051|Secondary|Efficacy as Measured by PSA Level|Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.|Cycle 5 Day 1, which is about about 32 weeks after treatment initiation|This time point is after 5 cycles of chemo so so no participants in the groups that had only 3/4 cycles were included. For the other group fewer were analyzed than the number that started study because for some treatment was prematurely stopped at different points in treatment because of adverse events, progression, and withdrawal from study.|||ng/mL||Full Range|Median
2568077|NCT02559414|Secondary|Percentage Monocyte-Platelet Aggregates|Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to inflammation|14 Days||||%aggregation||Standard Error|Mean
2568078|NCT02559414|Secondary|Percentage Platelet Aggregation in PRP After Stimulation With ADP 5μM for 5 Min||Baseline, 14 Days||||%aggregation||Standard Error|Mean
2568020|NCT02560051|Secondary|Efficacy as Measured by PSA Level|Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.|Cycle 4 Day 1, which is about 24 weeks after treatment initiation|"This time point is after 4 cycles of chemotherapy so no one in group definitive local therapy were analyzed. For the other groups fewer were analyzed than the number that started study because for some participants treatment was prematurely stopped at different points in treatment because of adverse events, progression, and withdrawal from study."|||ng/mL||Full Range|Median
2568021|NCT02560051|Secondary|Efficacy as Measured by PSA Level|Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.|Cycle 3 Day 1, which is about 16 weeks after treatment initiation|Fewer were analyzed than the number that started study because not all participants completed the full number of cycles of treatment assigned. For some participants treatment was prematurely discontinued at different points through the course of treatment because of adverse events, progression, and participant withdrawal from study.|||ng/mL||Full Range|Median
2568022|NCT02560051|Secondary|Efficacy as Measured by PSA Level|Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.|Cycle 2 Day 1, which is about 8 weeks after treatment initiation|Fewer were analyzed than the number that started study because not all participants completed the full number of cycles of treatment assigned. For some participants treatment was prematurely discontinued at different points through the course of treatment because of adverse events, progression, and participant withdrawal from study.|||ng/mL||Full Range|Median
2568023|NCT02560051|Secondary|Efficacy as Measured by PSA Level|Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.|Cycle 1 Day 1, which is the day of treatment initiation||||ng/mL||Full Range|Median
2568024|NCT02560051|Secondary|Efficacy as Measured by PSA Level|Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.|baseline||||ng/mL||Full Range|Median
2568025|NCT02560051|Secondary|Efficacy as Measured by Number of Participants With Pathology/Biopsy Positive for Disease||about 10 months after treatment initiation|Fewer were analyzed than the number that started or completed the study because not all participants were biopsied following treatment.|||Participants|||Count of Participants
2568026|NCT02560051|Primary|Efficacy as Measured by Number Who Progressed|Progression defined as increase in Prostate Specific Antigen (PSA) >0.3 ng/mL over 2 measurements or larger/new lesion|From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 10 months||||Participants|||Count of Participants
2568027|NCT02560038|Secondary|Efficacy as Measured by Number Who Progressed|"Progression is defined using RECIST 1.1 criteria:  At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)."|From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months||||Participants|||Count of Participants
2568028|NCT02560038|Secondary|Safety of Drug Regimen as Measured by Number of Adverse Events|Toxicity assessment will be observational. Numbers and types of events will be quantified and graded according to CTCAE.|From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months||||adverse event|||Number
2568029|NCT02560038|Primary|Efficacy as Measured by the Objective Response Rate (ORR).|Objective Response Rate (ORR) is defined as the proportion of patients achieving either a complete response or a partial response based on imaging at any time during the study. Complete response or partial response is based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 6 months||||Participants|||Count of Participants
2568030|NCT02560025|Secondary|Number of Participants With Serious Adverse Events|Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4). Adverse events were considered to be Serious Adverse Events (SAE) if they were grade 3 or greater and deemed to be possibly, probably, or definitely related to the study treatment.|From the start of treatment until 30 days after the last dose of a study drug is received, up to approximately 11 months|The three participants found to be ineligible after enrollment were excluded from the analysis|||Participants|||Count of Participants
2568031|NCT02560025|Secondary|Remission Duration||2 Years||2019-10-31|10/2019||||
2568032|NCT02560025|Secondary|Relapse Free Survival||1 Year||2019-10-31|10/2019||||
2568033|NCT02560025|Secondary|Overall Survival||1 Year||2019-10-31|10/2019||||
2568034|NCT02560025|Primary|Number of Participants That Achieved Complete Remission With Incomplete Blood Count Recovery (CRi)|"The number of participants that achieved a best overall response of CRi while on study.~Complete Remission with Incomplete Blood Count Recovery (CRi): Same as for CR but without achievement of ANC at least 1000/uL (CRi) and/or platelet count of 100,000/uL (CRp)."|From the start of treatment until the end of study treatment, up to approximately 10 months|The three participants found to be ineligible after enrollment were excluded from the analysis|||Participants|||Count of Participants
2568035|NCT02560025|Primary|Number of Participants That Achieved Complete Remission|"The number of participants that achieved a best overall response of complete remission while on study.~Complete remission (CR): Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/μL and a platelet count of 100,000/μL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, existing extramedullary disease. If possible, at least one bone marrow biopsy should be performed to confirm CR."|From the start of treatment until the end of study treatment, up to approximately 10 months|The three participants found to be ineligible after enrollment were excluded from the analysis|||Participants|||Count of Participants
2568036|NCT02560012|Primary|Number of Participants Who Progressed|"The PFS is defined as the time elapsed between treatment initiation and tumor progression or death from any cause, with censoring of patients who are lost to follow-up. Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1):  At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)."|From date of enrollment until the date of first documented progression, date of death from any cause, or date that the study was stopped, whichever came first, an average of 16 months|All participants who received personalized therapy (sunitinib, temsirolimus, sorafenib, or pazopanib) based on their tumor's profile.|||Participants|||Count of Participants
2568037|NCT02559713|Primary|Concentration of Vedolizumab in Breast Milk on Day 57|Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk in participants with analysis of vedolizumab concentration from the pooled milk sample was done by ELISA.|Day 57|Participants from PK Set, included all participants who were enrolled and received 1 dose of vedolizumab in study and had at least 1 measurable milk concentration, who received vedolizumab Q8W regimen prior to Day 1 with data available for this outcome measure were analyzed.|||ug/mL||Standard Deviation|Mean
2568038|NCT02559713|Primary|Concentration of Vedolizumab in Breast Milk on Day 29|Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).|Day 29|PK Set included all participants who were enrolled and received 1 dose of vedolizumab in the study and had at least 1 measurable milk concentration. Number analyzed is the number of participants who received specific vedolizumab regimen prior to Day 1.|||ug/mL||Standard Deviation|Mean
2568039|NCT02559713|Primary|Concentration of Vedolizumab in Breast Milk on Day 15|Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).|Day 15|PK Set included all participants who were enrolled and received 1 dose of vedolizumab in the study and had at least 1 measurable milk concentration. Number analyzed is the number of participants who received specific vedolizumab regimen prior to Day 1.|||ug/mL||Standard Deviation|Mean
2568040|NCT02559713|Primary|Concentration of Vedolizumab in Breast Milk on Day 8|Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).|Day 8|PK Set included all participants who were enrolled and received 1 dose of vedolizumab in the study and had at least 1 measurable milk concentration. Number analyzed is the number of participants who received specific vedolizumab regimen prior to Day 1.|||ug/mL||Standard Deviation|Mean
2568041|NCT02559713|Primary|Concentration of Vedolizumab in Breast Milk on Day 4|Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants unable to return to the clinic could have their milk samples collected at home by a qualified and trained homecare nurse. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).|Day 4|PK Set included all participants who were enrolled and received 1 dose of vedolizumab in the study and had at least 1 measurable milk concentration at the given timepoint. Number analyzed is the number of participants who received specific vedolizumab regimen prior to Day 1.|||ug/mL||Standard Deviation|Mean
2568042|NCT02559713|Primary|Concentration of Vedolizumab in Breast Milk at 1 Hour After the End of Infusion on Day 1|Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by ELISA. Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).|Day 1 (approximately 60 minutes after the end of infusion)|PK Set included all participants who were enrolled and received 1 dose of vedolizumab in the study and had at least 1 measurable milk concentration at the given timepoint. Number analyzed is the number of participants who received specific vedolizumab regimen prior to Day 1.|||ug/mL||Standard Deviation|Mean
2568111|NCT02557698|Secondary|Skin Surface pH at the Left Midvolar Forearm|Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH on the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.|Day 28 +/- 3||||non-dimensional||Standard Deviation|Mean
2568043|NCT02559713|Primary|Concentration of Vedolizumab in Breast Milk at Predose on Day 1|Milk from each breast was completely emptied using an electric milk pump at the specified time point for the determination of vedolizumab concentrations in the milk. Analysis of vedolizumab concentration from the pooled milk sample was done by enzyme-linked immunosorbent assay (ELISA). Participants were categorized as per their past vedolizumab regimens, received prior to Day 1: vedolizumab every 4 weeks (Q4W), vedolizumab every 6 weeks (Q6W), vedolizumab every 8 weeks (Q8W).|Day 1 (60 minutes prior to the start of infusion)|Pharmacokinetic Set (PK) included all participants who were enrolled and received 1 dose of vedolizumab in the study and had at least 1 measurable milk concentration. Number analyzed is the number of participants who received specific vedolizumab regimen prior to Day 1.|||ug/mL||Standard Deviation|Mean
2568044|NCT02559687|Secondary|Overall Survival (OS)|OS was defined as the time from first day of study treatment to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.|Up to approximately 28 months|All allocated participants who received at least 1 dose of study treatment.|||Months||95% Confidence Interval|Median
2568045|NCT02559687|Secondary|Progression Free Survival (PFS) According to RECIST 1.1 Assessed by BICR|PFS was defined as the time from first day of study treatment to the first documented PD or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of ≥1 new lesions was also considered PD. PFS as assessed by blinded independent central review per RECIST 1.1 was reported.|Up to approximately 28 months|All allocated participants who received at least 1 dose of study treatment.|||Months||95% Confidence Interval|Median
2568046|NCT02559687|Secondary|Duration of Response (DOR) According to RECIST 1.1 Assessed by BICR|For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. DOR assessments were based on blinded central imaging review with confirmation. The DOR per RECIST 1.1 for all participants who experienced a confirmed CR or PR was reported.|Up to approximately 28 months|All allocated participants who received at least 1 dose of study treatment and who experienced a confirmed CR or confirmed PR.|||Months||Full Range|Median
2568047|NCT02559687|Secondary|Number of Participants That Discontinued Study Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants that discontinued study treatment due to an AE was reported.|Up to approximately 24 months|All allocated participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2568048|NCT02559687|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants who experienced ≥1 AE was reported.|Up to approximately 28 months|All allocated participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2568049|NCT02559687|Primary|Objective Response Rate (ORR) According to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR)|ORR was defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR based on modified RECIST 1.1 was reported.|Up to approximately 28 months|All allocated participants who received at least 1 dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2568050|NCT02559622|Secondary|Change From Baseline in Leptin at Week 4, 12, 24 and 52|Leptin, a soluble biomarker of impaired lipid metabolism was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for Leptin of impaired lipid metabolism at week 4, 12, 24 and 52 for each arm, respectively"|||ng/mL (nanogram per milliliter)||95% Confidence Interval|Mean
2568051|NCT02559622|Secondary|Change From Baseline in Adiponectin at Week 4, 12, 24 and 52|Adiponectin, a soluble biomarker of impaired lipid metabolism was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for Adiponectin of impaired lipid metabolism at week 4, 12, 24 and 52 for each arm, respectively."|||ug/mL||95% Confidence Interval|Mean
2568052|NCT02559622|Secondary|Change From Baseline in Triglycerides, Total Cholesterol, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), Apolipoprotein A-1 (ApoA-1) and Apolipoprotein B (ApoB) at Week 4, 12, 24 and 52|Triglycerides, Total cholesterol, Low density lipoprotein (LDL), High density lipoprotein (HDL), Apolipoprotein A-1 (ApoA-1) and Apolipoprotein B (ApoB), soluble biomarkers of impaired lipid metabolism were determined in fasting blood samples to evaluate the effect of secukinumab on impaired lipid metabolism.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for Triglycerides, Total cholesterol, LDL, HDL, ApoA-1 and ApoB of impaired lipid metabolism at week 4, 12, 24 and 52 for each arm, respectively."|||mg/dL||95% Confidence Interval|Mean
2568054|NCT02559622|Secondary|Change From Baseline in Hemoglobin A1c (Glycated Hemoglobin) at Week 4, 12, 24 and 52|Hemoglobin A1c (glycated hemoglobin), a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for Hemoglobin A1c of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively."|||millimole per mole of Haemoglobin||95% Confidence Interval|Mean
2568055|NCT02559622|Secondary|Change From Baseline in Homeostatic Model Assessment (HOMA) Insulin Resistance at Week 4, 12, 24 and 52|HOMA insulin resistance, a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for HOMA insulin resistance of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively."|||Insulin Resistance Index||95% Confidence Interval|Mean
2568056|NCT02559622|Secondary|Change From Baseline in Homeostatic Model Assessment (HOMA) Beta-cell Function at Week 4, 12, 24 and 52|Homeostatic Model Assessment (HOMA) beta-cell function, a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for HOMA beta-cell function of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively."|||Percentage||95% Confidence Interval|Mean
2568057|NCT02559622|Secondary|Change From Baseline in Fasting Insulin at Week 4, 12, 24 and 52|Fasting Insulin, a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on Dysglycemia.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for Fasting Insulin of Dysglycemia at week 4, 12, 24 and 52 for each arm, respectively."|||micro units per millilitre (uU/mL)||95% Confidence Interval|Mean
2568058|NCT02559622|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 4, 12, 24 and 52|Fasting plasma glucose (FPG), a soluble biomarker of Dysglycemia was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for FPG at week 4, 12, 24 and 52 for each arm, respectively."|||mg/dL||95% Confidence Interval|Mean
2568059|NCT02559622|Secondary|Change From Baseline in Chemokine (C-c Motif) Ligand 5 (CCL5), Monocyte Chemoattractant Protein 1 (MCP-1) and Macrophage Inflammatory Proteins (MIP) 1 Alpha and 1 Beta at Week 4, 12, 24 and 52|Chemokine (c-c motif) ligand 5 (CCL5), Monocyte chemoattractant protein 1 (MCP-1) and Macrophage inflammatory proteins (MIP) 1 alpha (1A) and 1 beta (1B), soluble biomarkers of systemic inflammation were determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for CCL5, MCP-1, MIP-1A and MIP-1B at week 4, 12, 24 and 52 for each arm, respectively."|||picograms per milliliter (pg/mL)||95% Confidence Interval|Mean
2568060|NCT02559622|Secondary|Change From Baseline in S-100 Protein B (Total) at Week 4, 12, 24 and 52|S100 calcium-binding protein B (S100B-protein), a soluble biomarker of systemic inflammation was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for S100B-protein at week 4, 12, 24 and 52 for each arm, respectively."|||Microgram per Liter (ug/L)||95% Confidence Interval|Mean
2568061|NCT02559622|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 4, 12, 24 and 52|High sensitivity C-reactive protein (hsCRP), a soluble biomarker of systemic inflammation was determined in fasting blood samples to evaluate the effect of secukinumab on systemic inflammation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for hsCRP at week 4, 12, 24 and 52 for each arm, respectively."|||Milligrams per deciliter (mg/dL)||95% Confidence Interval|Mean
2568062|NCT02559622|Secondary|Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 52|Magnetic resonance imaging (MRI) was used to evaluate vessel wall morphometry to determine plaque burden. As a measure of plaque burden, average wall area was computed by subtracting vessel lumen area from total vessel area. Exploratory 3.0 Tesla MRI technique was applied to assess structure and function of the carotid and the aorta. A 2D axial dark blood T1, T2, proton density weighted spin echo based images and time of flight images were acquired from the bilateral carotid arteries as well as the descending aorta.|Baseline, Week 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for MRI sub-study at week 52 for each arm, respectively. MRI was applied in a sub-study population of 33 participants."|||mm^2||95% Confidence Interval|Mean
2568063|NCT02559622|Secondary|Change From Baseline in Average Wall Area Assessed as a Measure of Total Plaque Burden at Week 12|Magnetic resonance imaging (MRI) was used to evaluate vessel wall morphometry to determine plaque burden. As a measure of plaque burden, average wall area was computed by subtracting vessel lumen area from total vessel area. Exploratory 3.0 Tesla MRI technique was applied to assess structure and function of the carotid and the aorta. A 2D axial dark blood T1, T2, proton density weighted spin echo based images and time of flight images were acquired from the bilateral carotid arteries as well as the descending aorta.|Baseline, Week 12|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for MRI sub-study at week 12 for each arm, respectively. MRI was applied in a sub-study population of 33 participants."|||millimeter square (mm^2)||95% Confidence Interval|Mean
2568079|NCT02559414|Primary|Percentage Platelet Aggregation in PRP After Stimulation With Arachidonic Acid 1600 μM for 5 Min|The primary objective of these analyses will be to compare the effects of aspirin versus control and clopidogrel versus control for the outcome of platelet activity. Aspirin is expected to decrease arachidonic acid-induced platelet aggregation by 50% versus control. Clopidogrel is expected to decrease ADP-induced platelet aggregation by 50% versus control.|Baseline, 14 Days||||%aggregation||Standard Error|Mean
2568112|NCT02557698|Secondary|Skin Surface pH at the Left Midvolar Forearm|Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH on the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.|Day 14 +/- 2||||non-dimensional||Standard Deviation|Mean
2568064|NCT02559622|Secondary|Change From Baseline in Pulse Wave Velocity (PWV) at Week 4, 12, 24 and 52|Regional arterial pulse wave velocity (PWV) was directly related to arterial stiffness and was defined as the time it takes for the blood pressure wave to travel from a proximal site to a distal site (relative to the heart) divided by the distance (PWV = ∆distance/∆time [m/s]). The foot of the arterial pulse wave was being recorded by using the SphygmoCor XCEL device. XCEL simultaneously measures the pressure waveform at the femoral site (using a partially inflated custom blood pressure cuff) and the carotid site (using hand-held applanation tonometry). The foot-to-foot time between the two pressure waveforms was the time interval used in the PWV calculation.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, n signifies the sum of participants for all repeated measurements during calculation of mean, evaluable for pulse wave velocity (PWV) at Week 4, 12, 24 and 52 for each arm, respectively."|||meters per second (m/s)||95% Confidence Interval|Mean
2568065|NCT02559622|Secondary|Change From Baseline in Aortic Augmentation Index at Heart Rate of 75 (AIx-75) at Week 4, 12, 24 and 52|Pulse wave analysis was performed on the central aortic pressure waveform as derived by SphygmoCor XCEL from the brachial pressure waveform recorded in a partially-inflated blood pressure cuff around the upper arm. The waveform derivation employs a validated generalized transfer function to convert a brachial waveform to a central waveform and has been shown to produce measurement results corresponding to measurements using intra-arterial pressure catheters. The augmentation index is derived from the waveform by determining the percentage of the central pulse pressure during systole due to wave reflection. AIx was heart-rate corrected to calculate the AIx at a heart rate of 75 bpm, i.e. AIx-75.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for pulse wave analysis at weeks 4, 12, 24 and 52 for each arm, respectively."|||Percentage change in Alx-75||95% Confidence Interval|Mean
2568066|NCT02559622|Secondary|Change From Baseline in Flow Mediated Dilation (FMD) at Week 4, 12, 24 and 52|FMD is non-invasive method evaluated by Doppler Ultrasound test, to assess endothelial function. FMD was calculated as the percent maximal deviation from the baseline arterial diameter (D):FMD = 100*[(D maximum - D baseline) / D baseline]. Here, arterial diameter (brachial artery) was measured at rest (1 minute), during inflation of the distal cuff to 100 mmHg for 4.5 minutes and for 4.5 minutes following deflation. A positive change in FMD constitutes an improvement in endothelial function.|Baseline, Week 4, 12, 24 and 52|"The analysis was performed in FAS population. Here, Number analyzed signifies participants evaluable for FMD at weeks 4, 12, 24 and 52 for each arm, respectively."|||Percentage change in FMD||95% Confidence Interval|Mean
2568067|NCT02559622|Primary|Flow Mediated Dilation (FMD) at Week 12 Followed by Secukinumab 300 mg vs Pooled Placebo Treatment|Flow Mediated Dilation (FMD) is non-invasive method evaluated by Doppler Ultrasound test, to assess endothelial function. FMD was calculated as the percent maximal deviation from the baseline arterial diameter (D):FMD = 100*[(D maximum - D baseline) / D baseline]. Here, arterial diameter (brachial artery) was measured at rest (1 minute), during inflation of the distal cuff to 100 millimeter of mercury (mmHg) for 4.5 minutes and for 4.5 minutes following deflation.|Week 12|"The analysis was performed in Full analysis set (FAS) population, defined as all participants from the randomized set who received at least one dose of study drug. Here, Number analyzed signifies participants evaluable for FMD at Week 12 for each arm, respectively."|||Percentage maximal increase in diameter||Standard Deviation|Mean
2568068|NCT02559570|Secondary|Change From Baseline in 4-week Fecal Incontinence Daytime Symptoms Based on Evening Assessment|"Participants recorded the presence of incontinence episodes in daytime daily since pre-treatment period (14-day prior to randomization) in the evening eDiary for participants randomized following protocol amendment #3. The 4-week daytime fecal incontinence was calculated as the mean of non-missing participant scores reported in the evening eDiary during the Treatment Period. Baseline value was the average of values collected 14 days before randomization. Change from Baseline was calculated as the 4-week fecal incontinence daytime symptoms during the treatment period - fecal incontinence daytime symptoms at baseline. A negative change from Baseline indicates improvement.~No data is reported for LIN 145 μg as it was an exploratory arm group."|Baseline (14-day prior to randomization) to Week 4|Participants from ITT population included all participants who had at least 1 postbaseline entry on BM characteristic assessments that determined occurrences of SBMs (i.e. BM frequency and rescue medication use) who were randomized following the implementation of fecal incontinence assessment in the protocol (amendment #3).|||incontinence episodes||Standard Deviation|Mean
2568069|NCT02559570|Secondary|Change From Baseline (CFB) in 4-week Overall Complete Spontaneous Bowel Movement Frequency Rate (CSBM/Week) During the Treatment Period|SBM was defined as a BM that occurred in the absence of laxative, suppository, or enema use on the calendar day of the BM or the calendar day before the BM. A CSBM was an SBM that was associated with a sense of complete evacuation. Participants recorded their assessment of the sensation of incomplete evacuation for each BM in the morning and evening eDiary. The 4-week overall CSBM frequency rate was calculated as [total number of CSBMs in the analysis period/number of days in the analysis period]*7). Baseline value was based on values collected 14 days before randomization and up to randomization. Change from Baseline was calculated as the CSBM frequency rate during the 4-week treatment period - CSBM frequency rate at baseline. A positive change from Baseline indicates improvement. LSM and SE were calculated using ANCOVA method.|Baseline (14-day prior to randomization and up to randomization) to Week 4|ITT population, all participants who had at least 1 postbaseline entry on BM characteristic assessments that determined occurrences of SBMs (i.e. BM frequency and rescue medication use). No data is reported for LIN 145 μg as it was an exploratory arm group. An observed-cases approach to missing postbaseline data was applied.|||CSBMs/week||Standard Error|Least Squares Mean
2568080|NCT02559310|Secondary|Investigator's Assessment of Clinical Response (IACR)|IACR was defined as resolution or improvement of a subject's clinical signs and symptoms such that no additional antibacterial therapy was administered for the treatment of the current episode of CABP.|IACR was assessed at the Test of Cure visit, 5 - 10 days after the last dose of study drug.|Clinically Evaluable population: Subset of ITT population having met additional pre-defined criteria.|||Participants|||Count of Participants
2568081|NCT02559310|Secondary|Investigator's Assessment of Clinical Response (IACR)|IACR was defined as resolution or improvement of a subject's clinical signs and symptoms such that no additional antibacterial therapy was administered for the treatment of the current episode of CABP|IACR was assessed at the Test-of-Cure visit; 5-10 days after the last dose of study drug.|Modified ITT population: All randomized subjects who received any amount of study drug.|||Participants|||Count of Participants
2568070|NCT02559570|Secondary|Change From Baseline (CFB) in 4-week Abdominal Bloating Daytime Symptoms Based on Evening Assessment|Participants recorded their assessment of abdominal bloating in the evening eDiary. Participants answered the question: How big and full did your tummy feel? on a scale, where: 0=none, 1=a tiny bit, 2=a little, 3=medium or 4=very, with a higher score indicating more severe bloating. Baseline value was the average of values collected 14 days before randomization. The 4-week daytime abdominal bloating symptoms were calculated as the average of non-missing scores reported in the evening eDiary during the treatment period. Change from Baseline was calculated as the 4-week daytime abdominal bloating score during the treatment period - daytime abdominal bloating score at baseline. A negative change from Baseline indicates improvement. LSM and SE were calculated using ANCOVA method.|Baseline (14-day prior to randomization) to Week 4|ITT population, all participants who had at least 1 postbaseline entry on BM characteristic assessments that determined occurrences of SBMs (i.e. BM frequency and rescue medication use). No data is reported for LIN 145 μg as it was an exploratory arm group. An observed-cases approach to missing postbaseline data was applied.|||score on a scale||Standard Error|Least Squares Mean
2568071|NCT02559570|Secondary|Change From Baseline (CFB) in 4-week of Severity of Straining|Severity of straining was scored on 5-point scale for question-When you pooped, how hard did you push? The score ranges from 0= not hard at all,1= I pushed a tiny bit hard,2= I pushed a little hard,3= I pushed hard,4= I pushed very hard with higher scores indicating more severe straining. Participants recorded degree of straining for each BM in morning and evening eDiary. Data was derived as adult derivation and weighted average. Scores during 4-week treatment period were calculated following two approaches - (1) following derivation similar in earlier adult studies, as mean of participant's non-missing, SBM associated straining scores during 4-week treatment period (adult derivation) and (2) as observed weighted average of daily straining scores during that period. Daily straining score was the average of non-missing morning and/or evening assessments of straining score from the SBMs reported by the participants on that specific day. LSM and SE were calculated using ANCOVA method.|Baseline (14-day prior to randomization and up to randomization) to Week 4|ITT population-participants who had at least 1 postbaseline entry on BM characteristic that determined occurrences of SBMs (BM frequency and rescue medication use). No data is reported for LIN 145 μg as it was exploratory arm group. Observed-cases approach used. Overall number of participants analyzed = who had data at Baseline and post-baseline.|||score on a scale||Standard Error|Least Squares Mean
2568072|NCT02559570|Secondary|Change From Baseline (CFB) in 4-week Stool Consistency|Participants used 7-point pediatric Bristol Stool Form (p-BSFS) scale to rate stool consistency for each BM in morning and evening eDiary where 1=small hard lumps or balls like pebbles,2=fat sausage shape but lumpy and hard,3=a sausage but with cracks on it,4=sausage or snake, smooth and soft,5=chicken nuggets, soft smooth blobs,6=oatmeal, fluffy mushy pieces,7=milkshake, watery. Scores in 4-week treatment period were calculated by 2 approaches-1) following derivation similar in earlier adult studies, mean of participants non-missing, SBM associated p-BSFS scores during 4-week treatment period (adult derivation),2) observed weighted average of daily p-BSFS scores during that period. Daily p-BSFS score was average of non-missing morning and/or evening assessments of p-BSFS score from SBMs reported by participants on that specific day. Baseline value was based on values collected 14 days before randomization up to randomization. LSM and SE were calculated using ANCOVA method.|Baseline (14-day prior to randomization and up to randomization) to Week 4|ITT population-participants who had at least 1 postbaseline entry on BM characteristic that determined occurrences of SBMs (BM frequency and rescue medication use). No data is reported for LIN 145 μg as it was exploratory arm group. Observed-cases approach used. Overall number of participants analyzed = who had data at Baseline and post-baseline.|||score on a scale||Standard Error|Least Squares Mean
2568073|NCT02559570|Primary|Change From Baseline (CFB) in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate During the Treatment Period|SBM was defined as a BM that occurred in the absence of laxative, suppository, or enema use on the calendar day of the BM or the calendar day before the BM. SBM rate was defined as SBMs/week during the 4-week Treatment period. Participants recorded the occurrence of BMs and use of rescue medication, morning and evening, daily in an eDiary since pretreatment period. The SBM frequency rate (SBMs/week) during the analysis period for each participant were calculated as [(total number of SBMs in the analysis period/number of days in the analysis period)*7]. Baseline value was based on values collected 14 days before randomization up to randomization. Change from Baseline was calculated as the SBM frequency rate during the 4-week treatment period - SBM frequency rate at baseline. A positive change from Baseline indicates improvement. Least squares mean (LSM) and standard error (SE) were calculated using analysis of covariance (ANCOVA) method.|Baseline (14-day prior to randomization and up to randomization) to Week 4|ITT population, all participants who had at least 1 postbaseline entry on BM characteristic assessments that determined occurrences of SBMs (i.e. BM frequency and rescue medication use). No data is reported for LIN 145 μg as it was an exploratory arm group. An observed-cases approach to missing postbaseline data was applied.|||SBMs/week||Standard Error|Least Squares Mean
2568074|NCT02559570|Secondary|Change From Baseline (CFB) in 4-week Daytime Abdominal Pain|The abdominal pain score was measured using 5-point scale. Participants answered the questions, How much did your tummy hurt as: 0=none, 1=a tiny bit, 2=a little, 3=some, and 4=a lot. The 4-week daytime abdominal pain was calculated as the average of nonmissing scores in evening eDiary during the Treatment Period with higher value indicating greater symptom severity. Baseline value was the average of non-missing values collected 14 days before randomization. Change from Baseline was calculated as the daytime abdominal pain score during the 4-week treatment period (i.e. average of non-missing daytime scores during 4-week treatment period) - daytime abdominal pain score at baseline. A negative change from Baseline indicates improvement. LSM and SE were calculated using ANCOVA method.|Baseline (14-day prior to randomization) to Week 4|ITT population, all participants who had at least 1 postbaseline entry on BM characteristic assessments that determined occurrences of SBMs (i.e. BM frequency and rescue medication use). No data is reported for LIN 145 μg as it was an exploratory arm group. An observed-cases approach to missing postbaseline data was applied.|||score on a scale||Standard Error|Least Squares Mean
2568075|NCT02559414|Secondary|Percentage Leukocyte-Platelet Aggregate|Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to endothelial function.|14 Days||||%aggregation||Standard Error|Mean
2568076|NCT02559414|Secondary|Percentage Monocyte-Platelet Aggregates|Secondary objectives will compare the effect of each antiplatelet therapy drug on biomarkers related to immune activity|14 Days||||%aggregation||Standard Error|Mean
2568082|NCT02559310|Primary|Early Clinical Response (ECR)|ECR was defined as survival with improvement in at least 2 signs and symptoms of CABP (relative to baseline), no worsening of any CABP sign or symptom, and no use of concomitant antibiotics (other than adjunctive linezolid, as allowed by the study protocol) for the treatment of CABP through the ECR assessment.|ECR was assessed 96 +/- 24 hours after the first dose of study drug.|Intent to Treat Analysis Set: All randomized subjects|||Participants|||Count of Participants
2568083|NCT02559206|Primary|Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR2 or IR vs. Placebo|"A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period.~Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder.~Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week.~Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week.~A participant with <4 days of completed eDiary data for that week is not considered a responder for that week."|up to Week 12|Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).|||Participants|||Count of Participants
2568084|NCT02559206|Primary|Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR1 or IR vs. Placebo|"A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period.~Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder.~Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week.~Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week.~A participant with <4 days of completed eDiary data for that week is not considered a responder for that week."|up to Week 12|Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).|||Participants|||Count of Participants
2568085|NCT02559206|Primary|Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR2 or IR vs. Placebo|A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.|Baseline, up to Week 12|Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).|||CSBMs/week||Standard Error|Least Squares Mean
2568086|NCT02559206|Primary|Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR1 or IR vs. Placebo|A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.|Baseline, up to Week 12|Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).|||CSBMs/week||Standard Error|Least Squares Mean
2568087|NCT02559206|Primary|Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo|"Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom at its worst in past 24 hours. A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week."|Baseline, up to Week 12|Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).|||score on a scale||Standard Error|Least Squares Mean
2568088|NCT02559206|Primary|Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo|"Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom at its worst in past 24 hours. A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week."|Baseline, up to Week 12|Intent to Treat Population: all randomized participants who received at least one dose of study drug (evaluated according to assigned treatment).|||score on a scale||Standard Error|Least Squares Mean
2568089|NCT02558894|Secondary|Presence of ADAs for Tremelimumab|ADA prevalence was the proportion of the ADA evaluable set who had an ADA positive result at any point in time, baseline or post-baseline. ADA incidence (treatment-emergent ADA) was the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA positive patients as a proportion of the evaluable patient population. Treatment-boosted ADA was defined as baseline positive ADA titre boosted to a 4-fold or higher level following IP administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Results are reported as number of patients with detectable anti- tremelimumab antibodies satisfying each of the indicated categories. Note: 'positive' is denoted by 'pos' in some category titles.|Immunogenicity samples were collected on Day 1 (Week 0), Week 4 and Week 12, and additionally at 3 months and 6 months after the last dose (follow-up).|The ADA evaluable set included all patients in the safety analysis set (i.e. those who had received any IP) who had non-missing baseline ADA data and at least 1 non-missing post-baseline ADA result.|||Participants|||Count of Participants
2568090|NCT02558894|Secondary|Presence of Antidrug Antibodies (ADAs) for Durvalumab (MEDI4736)|ADA prevalence was the proportion of the ADA evaluable set who had an ADA positive result at any point in time, baseline or post-baseline. ADA incidence (treatment-emergent ADA) was the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA positive patients as a proportion of the evaluable patient population. Treatment-boosted ADA was defined as baseline positive ADA titre boosted to a 4-fold or higher level following IP administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Results are reported as number of patients with detectable anti-durvalumab antibodies satisfying each of the indicated categories. Note: 'positive' is denoted by 'pos' in some category titles.|Immunogenicity samples were collected on Day 1 (Week 0), Week 4, Week 12 and Week 24, and additionally at 3 months and 6 months after the last dose (follow-up).|The ADA evaluable set included all patients in the safety analysis set (i.e. those who had received any IP) who had non-missing baseline ADA data and at least 1 non-missing post-baseline ADA result.|||Participants|||Count of Participants
2568091|NCT02558894|Secondary|PK of Tremelimumab|To evaluate PK, blood samples were collected pre- and post-dose and tremelimumab concentrations in serum were determined. On Day 1 of Cycles 1 and 4 (Weeks 0 and 12), PK samples were collected pre-dose (within 60 minutes prior to treatment with any IP) and post-dose at the end of infusion (within 10 minutes of end of infusion of tremelimumab). On Day 1 of Cycle 2 (Week 4), PK samples were collected pre-dose (within 60 minutes prior to treatment with any IP) only. The 3-month follow-up sample for tremelimumab was relative to the respective last dose. Results are reported as mean pre- or post-dose tremelimumab concentrations as indicated by the individual categories (1 cycle=4 weeks). Samples below lower limit of quantification were treated as missing in the analyses.|Blood samples were collected pre-dose on Day 1 (Week 0), Week 4 and Week 12, post-dose on Day 1 and Week 12, and additionally at 3 months after the last dose (follow-up).|The PK analysis set included all patients who received at least 1 dose of IP, and had PK sampling data post-dose without important deviations or events to affect PK (n=64). Only patients with data available at the timepoints of testing were included in the analyses.|||mcg/mL||Standard Deviation|Mean
2568092|NCT02558894|Secondary|Pharmacokinetics (PK) of Durvalumab (MEDI4736)|To evaluate PK, blood samples were collected pre- and post-dose and durvalumab (MEDI4736) concentrations in serum were determined. On Day 1 of Cycles 1, 4 and 7 (Weeks 0, 12 and 24), PK samples were collected pre-dose (within 60 minutes prior to treatment with any IP) and post-dose at the end of infusion (within 10 minutes of end of infusion of durvalumab and within 10 minutes of end of infusion of tremelimumab [for patients receiving durvalumab plus tremelimumab]). On Day 1 of Cycle 2 (Week 4), PK samples were collected pre-dose (within 60 minutes prior to treatment with any IP) only. The 3-month follow-up sample for durvalumab was relative to the respective last dose. Results are reported as mean pre- or post-dose durvalumab concentrations as indicated by the individual categories (1 cycle=4 weeks). Samples below lower limit of quantification were treated as missing in the analyses.|Blood samples were collected pre-dose on Day 1 (Week 0), Week 4, Week 12 and Week 24, post-dose on Day 1, Week 12 and Week 24, and additionally at 3 months after the last dose (follow-up).|The PK analysis set included all patients who received at least 1 dose of IP, and had PK sampling data post-dose without important deviations or events to affect PK (n=64). Only patients with data available at the timepoints of testing were included in the analyses.|||Micrograms per millilitre (mcg/mL)||Standard Deviation|Mean
2568093|NCT02558894|Secondary|Disease Control Rate (DCR) Using Investigator Assessments According to RECIST 1.1|DCR at 3 months was defined as the percentage of patients who have a BoR of CR or PR in the first 3 months or who have demonstrated SD for a minimum interval of 13 weeks following the start of treatment. DCR at 6 months was defined as the percentage of patients who have a BoR of CR or PR in the first 6 months or who have demonstrated SD for a minimum interval of 26 weeks following the start of treatment. DCR at 12 months was defined as the percentage of patients who have a BoR of CR or PR in the first 12 months or who have demonstrated SD for a minimum interval of 52 weeks following the start of treatment. Results are reported as the percentage of patients with disease control for each of the indicated categories.|From date of first infusion until confirmed disease progression or death (up to 3 months, 6 months and 12 months)|The FAS included all randomised patients.|||Percentage of participants||95% Confidence Interval|Number
2568094|NCT02558894|Secondary|Best Objective Response (BoR) Using Investigator Assessments According to RECIST 1.1|BoR was calculated based on the overall visit responses from each RECIST assessment. It was the best response a patient had following date of first dosing but prior to starting any subsequent cancer therapy and prior to RECIST progression or last evaluable assessment in absence of RECIST progression. Categorisation of BoR was based on RECIST using the following response categories: CR and PR for status of 'Response'; Stable Disease (SD) ≥6 weeks, Progressive Disease (PD) and Not Evaluable (NE) for status of 'Non-response'. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD was defined as at least a 20% increase in the sum of diameters of TLs taking as reference the smallest sum on study. NE was only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit. Results are reported as number of patients with BoR for each of the indicated categories.|From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)|The FAS included all randomised patients.|||Participants|||Count of Participants
2568095|NCT02558894|Secondary|Survival Status, Presented as OS Rate, at 6 Months and at 12 Months|OS was defined as the time from the date of randomisation until death due to any cause. OS rates were calculated using Kaplan-Meier estimates of the cumulative probability of survival at each indicated time period. The OS rate at 6 months and 12 months was equivalent to the percentage of patients with OS after 6 months and 12 months, respectively.|From date of first infusion until death (up to 6 months and 12 months)|The FAS included all randomised patients.|||Percentage of participants||95% Confidence Interval|Number
2568096|NCT02558894|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomisation until death due to any cause. Results are reported as median OS, calculated using the Kaplan-Meier technique.|From date of first infusion until death (up to approximately 18 months for the data analysis cut-off)|The FAS included all randomised patients.|||Months||95% Confidence Interval|Median
2568097|NCT02558894|Secondary|PFS Rate at 3 Months and at 6 Months|PFS was defined as the time from the date of randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient had withdrawn from randomised therapy or had received another anti-cancer therapy prior to progression. PFS rates were calculated using Kaplan-Meier estimates of the cumulative probability of PFS. The PFS rate at 3 months and 6 months was equivalent to the percentage of patients with PFS after 3 months and 6 months, respectively.|From date of first infusion until confirmed disease progression or death (up to 3 months and 6 months)|The FAS included all randomised patients.|||Percentage of participants||95% Confidence Interval|Number
2568098|NCT02558894|Secondary|Progression-free Survival (PFS) Using Investigator Assessments According to RECIST 1.1|PFS was defined as the time from the date of randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient had withdrawn from randomised therapy or had received another anti-cancer therapy prior to progression. Results are reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique.|From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)|The FAS included all randomised patients.|||Months||95% Confidence Interval|Median
2568099|NCT02558894|Primary|Objective Response Rate (ORR) in All Patients Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|ORR was defined as the percentage of patients with at least one visit response of confirmed complete response (CR) or partial response (PR). CR was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have had reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of TLs, taking as reference the baseline sum of diameters. A confirmed response meant that a response of CR/PR was recorded at 1 visit and confirmed by repeat imaging, preferably at the next regularly scheduled imaging visit and not less than 4 weeks after the visit when response was first observed with no evidence of progression between the initial and CR/PR confirmation visits. Results are reported as percentage of patients with a confirmed response and percentage of patients with confirmed or unconfirmed responses (i.e., including single visit responses).|From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)|The FAS included all randomised patients.|||Percentage of participants||95% Confidence Interval|Number
2568100|NCT02558829|Other Pre-specified|Agreement (Positive/Negative) for MAC Core Study Part and MAC Repeatability Extension (Amendment 1)|Amendment no 1 (repeatability extension) had been issued for selected sites in Europe to obtain exploratory data on the repeatability of the MAC in a subset of subjects that had completed the core study. Pre-defined MAC cut-off point GH: 2.8 ng/mL. Agreements were calculated with two-sided 95% confidence intervals.|90 minutes|All subjects included in the modified intention-to-treat (mITT) analysis who also participated in the repeatability extension, i.e. N=34 (comprising 13 Group A, 12 Group B, and 9 Group C subjects).|||Participants|||Count of Participants
2568101|NCT02558829|Other Pre-specified|Sensitivity and Specificity of the MAC, GH: 2.8 ng/mL|Exploratory evaluation of sensitivity and specificity of the MAC as performance characteristic, based on test outcome in Group A and Group D subjects.|90 minutes|All high likelihood AGHD subjects of Group A (N=38) of the mITT population as ‘true’ AGHD subjects and all healthy matching subjects of Group D (N=25) of the mITT population as ‘true’ AGHD negative subjects|||Participants|||Count of Participants
2568102|NCT02558829|Secondary|ECG: Change in Heart Rate From Baseline at 60 Minutes Post-dose|During the GHSTs, ECGs were measured at pre-dose (up to 15 min before) and 60 minutes post-dose. Furthermore, ECGs were measured at screening and at End-of-Study (EOS) Visit.|60 minutes|All subjects of Group A, B, C, D in the safety population. Because of single ECGs missing, the number of participants analyzed here is lower than the number of the subjects in the SAF.|||beats per minute||Standard Deviation|Mean
2568103|NCT02558829|Secondary|Number of Participants With Any Test Emergent Adverse Event (TEAE), With Any TEAE Likely or Possibly Related, and With Any Test Emergent Severe AE|GHST ('Test') emergent AEs (TEAEs): AEs occurring or observed from the day of first GHST (administration of an IMP) throughout End-of-Study (EOS) visit or Early Termination, whichever occurred first. TEAEs were analyzed and compared for both GHSTs. Detailed listings are presented in the Adverse Events section. The frequencies presented in this section refer to number of subjects with any TEAE, each subject was counted only once within each category.|up to 70 days|All subjects of Group A, B, C, D in the safety population.|||Participants|||Count of Participants
2568104|NCT02558829|Secondary|Overall Agreements (Positive/ Negative) for MAC and ITT|As part of the secondary efficacy analysis, the percent of overall agreement was analyzed, using the same methodology described for the analyses for the primary efficacy variables.|90 minutes|All subjects from Groups A, B, C, D included in the modified intention-to-treat (mITT) analysis, N=140|||Participants|||Count of Participants
2568105|NCT02558829|Primary|Co-primary Efficacy Variables: Percent Positive and Percent Negative Agreement of Macimorelin-GHST (MAC) With ITT|"In the primary efficacy analysis, the estimated percentages of the agreements and the two-sided 95% confidence interval (or one-sided 97.5% confidence interval) of the percent agreement based on Clopper-Pearson are presented. The probability for a Negative Agreement equals the sum of the probability of both tests being correct (negative test results for both tests for subjects with true non-AGHD) and the probability of both tests being wrong (negative test results for both tests for subjects with true AGHD).~The performance of the GHST with Macimorelin was considered to be acceptable if the lower bound of the two-sided 95% confidence interval (or lower bound of the one-sided 97.5% confidence interval) for the primary efficacy variables was 75% or higher for 'percent negative agreement', and 70% or higher for the 'percent positive agreement'.~The following cut-off values for stimulated GH levels were used: - MAC: GH: 2.8 ng/mL, - ITT: GH: 5.1 ng/mL."|90 minutes|All subjects from Groups A, B, C, D included in the modified intention-to-treat (mITT) analysis, N=140|||Participants|||Count of Participants
2568106|NCT02558790|Primary|Change in Adult ADHD Investigator Symptom Rating Scale (AISRS) Score|"The Adult ADHD Investigator Symptom Report Scale (AISRS) assesses each of the 18 individual symptoms of ADHD in DSM-IV on a Likert scale from 0 (not present) to 3 (severe), with a total possible score of 54.~The change in AISRS score from baseline to endpoint (12 weeks) was calculated as the later time point score minus the earlier time point score."|Baseline and 12 Weeks||||units on a scale||Standard Deviation|Mean
2568107|NCT02558400|Secondary|Extent of Exposure|Exposure to study medication in days for all treatment groups|12 months|The safety population= all randomized subjects who received at least 1 dose of study medication. The safety population summarized subjects as-treated. 1 Subject was randomized to netarsudil but received latanoprost. Therefore, 1 less subject is in the netarsudil group and 1 additional subject is in the latanoprost group for the safety population.|||days||Standard Deviation|Mean
2568108|NCT02558400|Primary|Intraocular Pressure (IOP)|The primary efficacy variable was mean IOP at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry. Secondary analysis were conducted as a part of safety measurements to month 12 on treatment.|Primary efficacy endpoint measured for 3 months (data collected at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90)|Intent to Treat (ITT) population|||mmHg||Standard Deviation|Mean
2568109|NCT02558374|Secondary|Extent of Exposure|Exposure to study medication in days for all treatment groups|6 months|Safety Population|||days||Standard Deviation|Mean
2568110|NCT02558374|Primary|IOP (Intraocular Pressure)|The primary efficacy outcome is mean IOP|3 months|Per-Protocol Population|||mmHg||Standard Deviation|Mean
2571688|NCT02513732|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|0 to 2 years|ITT population|||Participants|||Count of Participants
2568113|NCT02557698|Secondary|Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.|Day 28 +/- 3||||µm||Standard Deviation|Mean
2568114|NCT02557698|Secondary|Skin Surface Mean Roughness (Rz) in µm at the Left Midvolar Forearm|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.|Day 14 +/- 2||||µm||Standard Deviation|Mean
2568115|NCT02557698|Secondary|Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness|Day 28 +/- 3||||µm||Standard Deviation|Mean
2568116|NCT02557698|Secondary|Skin Surface Mean Roughness (Ra) in µm at the Left Midvolar Forearm|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness|Day 14 +/- 2||||µm||Standard Deviation|Mean
2568117|NCT02557698|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm|"SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher the SCH. Per investigational site three replicate measurements were carried out.~Visit 3 (day 28)"|Day 28 +/- 3||||Arbitrary Units||Standard Deviation|Mean
2568118|NCT02557698|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Left Midvolar Forearm|"SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher the SCH. Per investigational site three replicate measurements were carried out.~Visit 2 (day 14)"|Day 14 +/- 2||||Arbitrary Units||Standard Deviation|Mean
2568119|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Trunk|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28) - end of study visit"|Day 28 +/- 3|ODS score 0-4|||Participants|||Count of Participants
2568120|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Trunk|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day 14)"|Day 14 +/- 2|ODS score 0-4|||Participants|||Count of Participants
2568121|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Right Lower Leg|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28)"|Day 28 +/- 3|ODS score 0-4|||Participants|||Count of Participants
2568122|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Right Lower Leg|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day 14) - intermediate visit"|Day 14 +/- 2|ODS score 0-4|||Participants|||Count of Participants
2568123|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Left Lower Leg|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28) - end of study visit"|Day 28 +/- 3|ODS score 0-4|||Participants|||Count of Participants
2568124|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Left Lower Leg|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day 14) - intermediate visit"|Day 14 +/- 2|ODS score 0-4|||Participants|||Count of Participants
2568198|NCT02556918|Secondary|Number of Subjects With Hyperglycemia (Blood Glucose Greater Than or Equal to 300 mg/dL) in Non-ICU|Number of subjects with hyperglycemia (blood glucose greater than or equal to 300 mg/dL) in non-ICU recovery period.|10 days (average time of discharge from the hospital)||||Participants|||Count of Participants
2568125|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Right Arm|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 3 (day 28)"|Day 28 +/- 3|ODS score 0-4|||Participants|||Count of Participants
2568126|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Right Arm|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day14)"|Day 14 +/- 2|ODS score 0-4|||Participants|||Count of Participants
2568127|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Left Arm|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness by the investigator using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks)"|Day 28 +/- 3||||Participants|||Count of Participants
2568128|NCT02557698|Secondary|Overall Dry Skin (ODS) Score at the Left Arm|"The Overall Dry Skin score is a standardized instrument to clinically assess the presence or severity of skin dryness using a five point rating scale according to Serup1995, Kang et al. 2014 on both arms, lower legs and trunk.~(0=Absent, 1=Faint scaling, faint roughness and dull appearance, 2=Small scales in combination with a few larger scales, slight roughness and whitish appearance, 3=Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks, 4=Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks) Visit 2 (day14) - intermediate visit"|Day 14 +/- 2|ODS score 0-4|||Participants|||Count of Participants
2568129|NCT02557698|Secondary|Skin Surface pH at the Right Lateral Lower Leg|Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH of the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.|Day 28 +/- 3||||non-dimensional||Standard Deviation|Mean
2568130|NCT02557698|Secondary|Skin Surface pH at the Right Lateral Lower Leg|Skin surface pH was measured using the Skin-pH-Meter PH905 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Parra et al. 2003). The pH of the skin surface may differ from the pH of the stratum corneum. Means of triple measurements/images per skin area.|Day 14 +/- 2||||non-dimensional||Standard Deviation|Mean
2568131|NCT02557698|Secondary|Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.|Day 28 +/- 3||||µm||Standard Deviation|Mean
2568132|NCT02557698|Secondary|Skin Surface Mean Roughness (Rz) in µm at the Right Lateral Lower Leg|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. The parameter Rz was calculated. Rz=mean roughness of five equally spaced sampling lenghts.|Day 14 +/- 2||||µm||Standard Deviation|Mean
2568133|NCT02557698|Secondary|Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness|Day 28 +/- 3||||µm||Standard Deviation|Mean
2568134|NCT02557698|Secondary|Skin Surface Mean Roughness (Ra) in µm at the Right Lateral Lower Leg|Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra=mean roughness|Day 14 +/- 2||||µm||Standard Deviation|Mean
2568135|NCT02557698|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg|"SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher is SCH. Per investigational site three replicate measurements were carried out.~Visit 3 (day 28)"|Day 28 +/- 3||||Arbitrary Units||Standard Deviation|Mean
2568136|NCT02557698|Secondary|Stratum Corneum Hydration (SCH) in Arbitrary Units at the Right Lateral Lower Leg|"SCH was measured using the Corneometer (Courage+Khazaka, Cologne, Germany) according to international guidelines which measured the hydratation level of the stratum corneum as electrical capacitance (Berardesca et al. 1997). The higher the values, the higher the SCH. Per investigational site three replicate measurements were carried out.~Visit 2 (day 14)"|Day 14 +/- 2||||Arbitrary Units||Standard Deviation|Mean
2568137|NCT02557698|Secondary|Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg|"TEWL was measured using the Tewameter TM300 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Rogiers 2001). This open chamber intrument measured water evaporation from the skin by temperature and humidity sensors inside the cylinder. Means of triple measurements per skin area in g/m2/h at the right lateral lower leg.~Visit 3 (day 28)"|Day 28 +/- 3||||g/m2/h||Standard Deviation|Mean
2568138|NCT02557698|Secondary|Transepidermal Water Loss (TEWL) in g/m2/h at the Right Lateral Lower Leg|"TEWL was measured using the Tewameter TM300 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Rogiers 2001). This open chamber intrument measured water evaporation from the skin by temperature and humidity sensors inside the cylinder. Means of triple measurements per skin area in g/m2/h at the right lateral lower leg.~Visit 2 (day14)"|Day 14 +/- 2||||g/m2/h||Standard Deviation|Mean
2568139|NCT02557698|Secondary|Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm|"TEWL was measured using the Tewameter TM300 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Rogiers 2001). This open chamber intrument measured water evaporation from the skin by temperature and humidity sensors inside the cylinder. Means of triple measurements per skin area in g/m2/h on the left midvolar forearm.~Visit 2 (day14) - intermediate visit"|Day 14 +/- 2||||g/m2/h||Standard Deviation|Mean
2568140|NCT02557698|Primary|Transepidermal Water Loss (TEWL) in g/m2/h at the Left Mid Volar Forearm|"TEWL was measured using the Tewameter TM300 (Courage+Khazaka, Cologne, Germany) according to international guidelines (Rogiers 2001). This open chamber intrument measured water evaporation from the skin by temperature and humidity sensors inside the cylinder. Means of triple measurements per skin area in g/m2/h on the left midvolar forearm.~Visit 3 (day 28) - end of study visit"|Day 28 +/- 3|Male or female gender, aged between 6 months and 85 years|||g/m2/h||Standard Deviation|Mean
2568141|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.|Up to 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.|||percentage of participants|||Number
2568142|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each body weight-normalized dose group (<5mg/kg/day, 5-10 mg/kg/day, 10-15 mg/kg/day, 15-20 mg/kg/day, and >20 mg/kg/day) is presented.|Up to 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.|||percentage of participants|||Number
2568143|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose group (600 mg, 800 mg, 1000 mg, 1200 mg, and 1400 mg) is presented.|Week 4, 12, 24, at EOT Visit, 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.|||percentage of participants|||Number
2568144|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with viral relapse or breakthrough in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each cumulative dose group (<60%, 60-69%, 70-79%, 80-89%, and >90%) is reported.|Up to 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.|||percentage of participants|||Number
2568145|NCT02557646|Secondary|Percentage of Participants With Viral Relapse or Breakthrough|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough is reported.|Up to 24 weeks after EOT (maximum up to 96 weeks)|ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.|||percentage of participants|||Number
2568146|NCT02557646|Secondary|Percentage of Participants With SVR According to IL-28B Polymorphism|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR for each IL-28B allele (CC allele, CT allele, TT allele) is presented.|24 weeks after EOT (maximum up to 96 Weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||percentage of participants|||Number
2568199|NCT02556918|Secondary|Number of Subjects With Hyperglycemia in Intensive Care Unit (ICU)|Number of subjects with hyperglycemia (blood glucose greater than or equal to 300 mg/dL) in ICU recovery period.|2 days (average time of discharge from ICU)||||Participants|||Count of Participants
2568147|NCT02557646|Secondary|Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response for each IL-28B allele (CC allele, CT allele, TT allele) is presented.|Up to EOT (maximum up to 72 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||percentage of participants|||Number
2568148|NCT02557646|Secondary|Percentage of Participants With SVR According to Dose Reduction of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.|24 weeks after EOT (maximum up to 96 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||percentage of participants|||Number
2568149|NCT02557646|Secondary|Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.|Up to EOT (maximum up to 72 weeks)|ITT Population.|||percentage of participants|||Number
2568150|NCT02557646|Secondary|Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each body weight-normalized dose group is presented.|24 weeks after EOT (maximum up to 96 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||percentage of participants|||Number
2568151|NCT02557646|Secondary|Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each body weight-normalized (measured in milligram per kilogram per day [mg/kg/day]) dose group is presented.|Up to EOT (maximum up to 72 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||percentage of participants|||Number
2568152|NCT02557646|Secondary|Percentage of Participants With SVR According to Starting Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose group is presented.|24 weeks after EOT (maximum up to 96 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||percentage of participants|||Number
2568153|NCT02557646|Secondary|Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose group is presented.|Up to EOT (maximum up to 72 weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||percentage of participants|||Number
2568154|NCT02557646|Secondary|Percentage of Participants With Virologic Response|Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response.|Week 4, 12, 24 and at EOT (maximum up to 72 weeks)|ITT Population.|||percentage of participants|||Number
2568172|NCT02557399|Secondary|Percentage of Participants With a Minimum of 2-grade Improvement in Investigator's Static Global Assessment (ISGA) Score From Baseline to Weeks 1, 2, 4, 8 and 12|Responder was defined as participants with a minimum 2-grade improvement in ISGA score from Baseline. ISGA scale was scored from 0-5 (0= Clear skin with no inflammatory or non-ILs, 1= Almost clear: rare non-ILs present, with no more than rare papules, 2= Mild severity: greater than Grade 1, some non-ILs with no more than few inflammatory lesions, 3= Moderate severity: greater than Grade 2, many non-ILS, may have some ILs, but no more than 1 small nodular lesion, 4= Severe: greater than Grade 3, up to many non-ILs and ILs, but no more than a few nodular lesions, 5= Very severe: many non -ILs and ILs and more than a few nodular lesions. May have cystic lesions). Percentage of participants was calculated by dividing number of participants with 2-grade improvement in ISGA score from Baseline by total number of participants value multiplied by 100.|Week 1, 2, 4, 8, 12|ITT population.|||Percentage of participants|||Number
2568155|NCT02557646|Primary|Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin|Determination of hepatitis C virus (HCV) titers was performed using COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C, at Weeks 4, 12 and 24 of the treatment period (and, optionally, at the end of treatment [EOT] visit), and at the end of the 24-week follow-up period. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100.|24 weeks after EOT (maximum up to 96 Weeks)|ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||percentage of participants|||Number
2568156|NCT02557555|Primary|Survey to Determine Utility and Effect of Educational Materials|In order to assess the educational value of the pamphlet provided to parturients we evaluated all the questions pertaining education. There is no nominal value reported in units as all the data is merely described as the percentage of patients responding to educational questions. For example, 93% of patients (91/98) responded Yes to the question -Do you think the pamphlet you received did a better job explaining your options for control of labor pain than what you answered in the previous question <patient research>?|expected average of no later than 48 hours following delivery|The answers from 100 female patients, ages 18-45 admitted to the L&D who answered our survey were analyzed to gage the educational value of our labor analgesia informational pamphlet.|||percentage of patients responding|||Number
2568157|NCT02557516|Secondary|Overall Survival|The overall survival (OS) is defined as the time from first dose administration until death from any cause. Alive patients were censored at the most recent date they were known to be alive. Subjects with no assessment post-Baseline were censored at the day of the first dose administration.|Up to 24 months.|22 patients were included in the ITT / Safety population|||Month||95% Confidence Interval|Median
2568158|NCT02557516|Secondary|Progression Free Survival|The Progression Free Survival (PFS) is defined as the time from first dose administration until the occurrence of progressive disease, relapsed disease or death from any cause. Patients without an event at the time of the analyse were censored at his or her last disease assessment date. Patients with no post-Baseline assessment were censored at the day of the first dose administration.|Up to 24 months|All 22 enrolled patients were included in the ITT / Safety population|||Month||95% Confidence Interval|Median
2568159|NCT02557516|Secondary|Duration of Remission|The duration of remission (DOR) is defined as the time from the date of first evaluation of the remission (cCR, uCR or PR) to the first documentation of progressive disease, relapsed disease or death. In case an assessment of progressive / relapsed disease or death does not exist, the DOR was censored at the time of the last disease assessment date. The DOR was calculated only for the patients with a remission that was assessed at 52 weeks.|Up to 24 months|21 patients evaluated for efficacy. 1 patient treated at 4 mg/kg was withdrawn due to grade 3 hemolytic anemia attribuated to disease progression at W4 and considered as not evaluable for efficacy. Due to the small size of the trial no subgroup analyses have been conducted.|||Month||95% Confidence Interval|Median
2568160|NCT02557516|Secondary|Best Overall Response / Remission Rates|"Measure of best overall response at any time during the study. cCR: confirmed complete response/remission; uCR: unconfirmed complete response / remission; PR: partial response/remission; SD: stable disease; PD: progressive disease.~Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL), Complete Response (CR) is defined as lymphocytes <4x109/l, absence of lymphadenopathy, hepatomegaly and splenomegaly at CT scan, no constitutional symptoms, no cytopenia, normocellular bone marrow. Partial Response (PR) is a reduction > 50% in lymphocytes, lymphadenopathy, spleen or liver, no cytopenia. PD if appearance of any new lesion, or increase in lymphocytes > 50%, or occurrence of cytopenia attributable to CLL.~In order to have a confirmed CR (cCR), the CR must be confirmed by a scan and a bone marrow assessment assessed at least 2 months after the first occurrence of CR. Otherwise it would be an unconfirmed CR (uCR)."|From beginning of study drug treatment to the end of study (up to 24 months)|Efficacy population: 21 patients who received at least one dose of monalizumab. According to the protocol, patients who discontinued treatment due to disease progression before the end of 8 weeks were replaced. Of note,1 patient (grade 3 hemolytic anemia due to disease progression at W4) was replaced and was then excluded from efficacy population.|||Participants|||Count of Participants
2568161|NCT02557516|Primary|Rate of Complete Response (CR)|The rate of complete response (CR) was evaluated using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) grading scale and confirmed by a bone marrow biopsy. Per International Workshop on Chronic Lymphocytic Leukemia (IWCLL), Complete Response (CR) is defined as lymphocytes <4x109/l, absence of lymphadenopathy, hepatomegaly and splenomegaly at CT scan, no constitutional symptoms, no cytopenia, normocellular bone marrow. Partial Response (PR) is a reduction > 50% in lymphocytes, lymphadenopathy, spleen or liver, no cytopenia. PD if appearance of any new lesion, or increase in lymphocytes > 50%, or occurrence of cytopenia attributable to CLL.|CR assessed 52 weeks after the beginning of combination treatment|Efficacy population: 21 patients who received at least one dose of monalizumab. According to the protocol, patients who discontinued treatment due to disease progression before the end of 8 weeks were replaced. Of note,1 patient (grade 3 hemolytic anemia due to disease progression at W4) was replaced and was then excluded from efficacy population.|||Participants|||Count of Participants
2568162|NCT02557516|Primary|Number of Dose Limiting Toxicities|Number of dose-limiting toxicities, measured during the phase 1, dose escalation, part of the study.|8 weeks|During phase 1 part of the study (dose escalation) the total number of patients evaluated for safety parameters is 13; 3 patients received at least one dose of monalizumab 1 mg/kg, 6 patients received 2 mg/kg , and 4 patients received 4 mg/kg.|||Dose Limiting Toxicy|||Number
2568163|NCT02557399|Secondary|Number of Participants With Severity of AEs|The severity of AEs was assessed by the investigator; events were assigned to one of the following categories: mild, an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate, an event that was sufficiently discomforting to interfere with normal everyday activities; and severe, an event that prevented normal everyday activities.|Up to Week 12|ITT population.|||Participants|||Count of Participants
2568164|NCT02557399|Secondary|Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging|Local tolerability score for erythema (no redness, faint red or pink coloration, barely perceptible, light red or pink coloration, medium red coloration, beet red coloration), dryness (none, barely perceptible dryness with no flakes or fissure formation, easily perceptible dryness with no flakes or fissure formation, easily noted dryness and flakes but no fissure formation, easily noted dryness with flakes and fissure formation), peeling (no peeling, mild localized peeling, mild and diffuse peeling, moderate and diffuse peeling, moderate to prominent, dense peeling) and itching and burning/stinging (normal-no discomfort, noticeable discomfort that causes intermittent awareness, continuous awareness, intermittent awareness and interferes occasionally with normal daily activities, a definite continuous discomfort that interferes with normal daily activities) was assessed on a scale of 0 to 4 (0= absent, 1= slight, 2= mild, 3= moderate and 4= severe).|Week 1, 2, 4, 8 and 12|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2568165|NCT02557399|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate. For liver injury and impaired liver function, alanine aminotransferase greater than or equal to (>=)3 times upper limit of normal (ULN) and total bilirubin >=2xULN (less than [>] 35% direct) was defined.|Up to Week 12|ITT population.|||Participants|||Count of Participants
2568166|NCT02557399|Secondary|Change From Baseline in Quality of Life (QoL) Score at Week 2, 4, 8 and 12|QOL questionnaire was assessed using Skindex-16 with 16 questions in 3 multi-item scales: symptoms, emotions and functioning for the past week: skin condition-itching, burning or stinging, hurting, being irritated, persistence/reoccurrence of skin condition, worry about condition, appearance of skin, frustration about skin, embarrassment about skin, being annoyed about your skin, feeling depressed about skin, effects of your skin on your interactions with others, effects of your skin condition on your desire to be with people, skin condition making it hard to show affection, effects of your skin condition on your daily activities and skin condition making it hard to work or do what you enjoy. Data for adjusted mean has been reported. The Baseline value was the latest pre-dose assessment value. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Scores range from 0-never bothered to 100-always bothered.|Baseline(Day 1) and Week 2, 4, 8 and 12|ITT population. Only those participants with data available at the specified time points were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2568167|NCT02557399|Secondary|Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12|Participants had to rate each question on a 5-point scale of 0 to 4 (4: yes, very easy to use, 3: yes, easy, 2: slightly easy, 1: slightly difficult, 0: No) where larger score indicates more preferable participant's feeling. There were 5 questions in the questionnaire: ease of application, comfort, satisfaction with treatment (ST), comparison with prior therapies (CPT) and willingness to continue using the product (WCP).|Week 1, 2, 4, 8 and 12|ITT population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2568168|NCT02557399|Secondary|Number of Participants Who Continued Treatment at Weeks 1, 2, 4, 8 and 12|Number of participants who continued the treatment till Week 12 was measured. Overall data for participants who have not missed any dose during the treatment period has been reported.|Up to Week 12|ITT population.|||Participants|||Number
2568169|NCT02557399|Secondary|Number of Participants With Treatment Adherence Rate at Weeks 1, 2, 4, 8 and 12|The investigator (or sub-investigator), the product storage manager, or the blinded coordinator dispensed a study compliance log to record participant's compliance with investigational product application from Baseline to the end of study treatment. The product storage manager or the blinded coordinator evaluated the participant's compliance with study treatment, using the study compliance log at each visit, and recorded the compliance data in the eCRF.|Week 1, 2, 4, 8 and 12|ITT population.|||Participants|||Number
2568170|NCT02557399|Secondary|Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12|Responder was defined as participants with at least a 50% reduction in TLs, ILs and non-ILs. Data for number of participants is reported. Percentage of participants was calculated by dividing number of responders by total number of participants value multiplied by 100.|Week 1, 2, 4, 8 and 12|ITT population. Only those participants with data available at the specified time points were analyzed.|||Percentage of participants|||Number
2568171|NCT02557399|Secondary|Percentage of Participants With ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8 and 12|Responder was defined as participant with ISGA score of 0 or 1. ISGA scale was scored from 0-5 (0= Clear skin with no inflammatory or non-ILs, 1= Almost clear: rare non-ILs present, with no more than rare papules, 2= Mild severity: greater than Grade 1, some non-ILs with no more than few inflammatory lesions, 3= Moderate severity: greater than Grade 2, many non-ILS, may have some ILs, but no more than 1 small nodular lesion, 4= Severe: greater than Grade 3, up to many non-ILs and ILs, but no more than a few nodular lesions, 5= Very severe: many non -ILs and ILs and more than a few nodular lesions. May have cystic lesions). Percentage of participants was calculated by dividing number of participants with 0-1 ISGA score post Baseline by total number of participants value multiplied by 100.|Week 1, 2, 4, 8 and 12|ITT population.|||Percentage of participants|||Number
2568173|NCT02557399|Secondary|Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12|The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator). A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM. The Baseline value was the latest pre-dose assessment value.|Baseline (Day 1) and Week 1, 2, 4, 8, 12|ITT population. Only those participants with data available at the specified time points were analyzed.|||lesion count||Standard Error|Least Squares Mean
2568174|NCT02557399|Secondary|Percent Change Form Baseline in Lesion Counts (ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12|The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones). Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator).|Baseline (Day 1) and Week 1, 2, 4, 8, 12|ITT population. Only those participants with data available at the specified time points were analyzed.|||Percent change in lesions||Standard Error|Least Squares Mean
2568175|NCT02557399|Secondary|Percent Change From Baseline in TLs to Weeks 1, 4, 8 and 12|The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator). A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.|Baseline (Day 1) and Week 1, 4, 8, 12|ITT population. Only those participants with data available at the specified time points were analyzed.|||Percent change in lesions||Standard Error|Least Squares Mean
2568176|NCT02557399|Primary|Percent Change in Total Lesion Counts (TLs) From Baseline to Week 2|The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-inflammatory lesions were counted by diagnosis based on palpation of the investigator (or sub-investigator).|Baseline (Day 1) and Week 2|Intent-to-Treat (ITT) population comprised of all randomized participants who received at least one application of study product. Only those participants with data available at the indicated time points were analyzed|||Percent change in lesions||Standard Error|Least Squares Mean
2568177|NCT02557035|Secondary|Percentage of Patients With no Rescue Medication in the Overall Phase||0-120 hours||||Participants|||Count of Participants
2568178|NCT02557035|Secondary|Percentage of Patients With no Rescue Medication in the Delayed Phase||>24-120 hours||||Participants|||Count of Participants
2568179|NCT02557035|Secondary|Percentage of Patients With no Rescue Medication in the Acute Phase||0-24 hours||||Participants|||Count of Participants
2568180|NCT02557035|Secondary|Percentage of Patients With no Emetic Episodes in the Overall Phase||0-120 hours||||Participants|||Count of Participants
2568181|NCT02557035|Secondary|Percentage of Patients With no Emetic Episodes in the Delayed Phase||>24-120 hours||||Participants|||Count of Participants
2568182|NCT02557035|Secondary|Percentage of Patients With no Emetic Episodes in the Acute Phase||0-24 hours||||Participants|||Count of Participants
2568183|NCT02557035|Secondary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase||0-120 hours||||Participants|||Count of Participants
2568184|NCT02557035|Secondary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase||>24-120 hours||||Participants|||Count of Participants
2568185|NCT02557035|Primary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase||0-24 hours||||Participants|||Count of Participants
2568186|NCT02556918|Secondary|Number of Subjects Returning to the ER Within 30 Days|Number of subjects returning to the ER within 30 days (all-cause).|30 days||||Participants|||Count of Participants
2568187|NCT02556918|Secondary|Number of Subjects Readmitted to the Hospital|Number of subjects readmitted to the hospital within 30 days (all-cause).|30 days||||Participants|||Count of Participants
2568188|NCT02556918|Secondary|Number of Cerebrovascular Events|Number of cerebrovascular events including permanent stroke and reversible ischemic neurologic deficit|10 days (average time of discharge from the hospital)||||events|||Number
2568189|NCT02556918|Secondary|Number of Intensive Care Unit (ICU) Readmission|Number of re-admissions to intensive care unit during the same hospital course.|10 days (average time of discharge from the hospital)||||readmissions|||Number
2568190|NCT02556918|Secondary|Total Length of Hospital Stay|Total number of days spent in hospital|10 days (average time of discharge from the hospital)||||days||Inter-Quartile Range|Median
2568191|NCT02556918|Secondary|Length of Intensive Care Unit (ICU) Stay|Total number of days spent in intensive care unit (ICU)|2 days (average time of discharge from ICU)||||days||Inter-Quartile Range|Median
2568192|NCT02556918|Secondary|Duration of Intubation|Duration that patients required to be intubated|10 days (average time of discharge from the hospital)||||days||Standard Deviation|Mean
2568193|NCT02556918|Secondary|Composite of Perioperative Complications|Number of perioperative complications including hospital mortality, infection,acute renal failure, and acute mycordial infarction.|10 days (average time of discharge from the hospital)||||events|||Number
2568194|NCT02556918|Secondary|Number of Patients With Severe Hypoglycemic Events in Non-intensive Care Unit (ICU)|Number of Patients With hypoglycemic events (blood glucose less than 40 mg/dL) in patients in non-intensive care unit (ICU).|10 days (average time of discharge from the hospital)||||Participants|||Count of Participants
2568195|NCT02556918|Secondary|Number of Patients With Severe Hypoglycemic Events in Intensive Care Unit (ICU)|Number of Patients With severe hypoglycemia (blood glucose less than 40 mg/dL) in patients in intensive care unit (ICU).|2 days (average time of discharge from ICU)||||Participants|||Count of Participants
2568196|NCT02556918|Secondary|Number of Patients With Hypoglycemic Events in Non-intensive Care Unit (ICU)|Number of Patients With hypoglycemic events (blood glucose less than 70 mg/dL) in patients in non-intensive care unit (ICU).|10 days (average time of discharge from the hospital)||||Participants|||Count of Participants
2568203|NCT02556918|Secondary|Median Number of Days of Subcutaneous (SC) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII)|Median number of days patients requiring SC insulin after discontinuation of CII|Up to 14 days (time of discharge from the hospital)|Some patients were not transitioned to SQ insulin because they stayed on CII due to complications, these patients were taken off the analysis|||days||Inter-Quartile Range|Median
2568204|NCT02556918|Secondary|Number of Patients Requiring Subcutaneous (SQ) Insulin After Discontinuation of Continuous Intravenous Insulin Infusion (CII)|Number of patients requiring subcutaneous (SQ) insulin after discontinuation of continuous intravenous insulin infusion (CII)|10 days (average time of discharge from the hospital)|Some patients were not transitioned to SQ insulin because they stayed on CII due to complications, these patients were taken off the analysis|||Participants|||Count of Participants
2568205|NCT02556918|Secondary|Duration of Continuous Intravenous Insulin Infusion (CII)|Total hours of continuous intravenous insulin infusion (CII)|Up to 48 hours (average time of discharge from ICU)||||hours||Standard Deviation|Mean
2568206|NCT02556918|Secondary|Mean Insulin Dose Per Day During Intensive Care Unit (ICU) Recovery|Mean insulin infusion dose per day of ICU patients during recovery period.|2 days (average time of discharge from ICU)||||unit/day||Standard Deviation|Mean
2568207|NCT02556918|Secondary|Total IV Insulin in ICU|Total IV insulin in ICU during recovery period.|2 days (average time of discharge from ICU)||||units||Standard Deviation|Mean
2568208|NCT02556918|Secondary|Mean Blood Glucose (BG) Concentration in the Intensive Care Unit (ICU)|Mean blood glucose (BG) concentration of ICU patients during recovery period.|2 days (average time of discharge from ICU)||||mmol/L||Standard Deviation|Mean
2568209|NCT02556918|Secondary|Number of Patients Requiring Continuous Intravenous Insulin Infusion (CII)|Number of patients requiring CII to achieve a blood glucose level (BG) target between 150-200 mg/dl|2 days (average time of discharge from ICU)||||Participants|||Count of Participants
2568210|NCT02556918|Primary|Number of Patients With Persistent Hyperglycemia|Number of patients with two consecutive fasting and/or pre-meal blood glucose (BG) greater than 180 mg/dl, or with average daily BG greater than 80 mg/dl who require rescue therapy with subcutaneous (SC) insulin after discontinuation of continuous intravenous insulin infusion (CII).|10 days (average time of discharge from the hospital)||||Participants|||Count of Participants
2568211|NCT02556918|Primary|Number of Patients With Hyperglycemia in the Intensive Care Unit (ICU)|Number of patients with blood glucose (BG) levels greater than 180 mg/dl|2 days (average time of discharge from ICU)||||Participants|||Count of Participants
2568212|NCT02556801|Other Pre-specified|Number and Severity of Systemic Reactions|"The total number and severity (Grade I, Grade II or Grade III) of systemic reactions in the active treatment groups and placebo treatment group. The grading was done according to the World Allergy Organization grading system:~Grade 0: No symptoms or non-immunotherapy-related symptoms Grade I: Mild systemic reactions, symptoms: localized urticaria, rhinitis or mild asthma (PF < 20% decrease from baseline) Grade II: Moderate systemic reactions, symptoms: Slow onset (>15 min) of generalized urticaria and/or moderate asthma (PF < 40% decrease from baseline) Grade III: Severe (non-life-threatening) systemic reactions, symptoms: Rapid onset (<15 min) of generalized urticaria, angioedema or severe asthma (PF > 40% decrease from baseline) Grade IV: Anaphylactic shock, symptoms: Immediate evoked reaction of itching, flushing, erythema, generalized urticaria, stridor (angioedema), immediate asthma, hypotension, etc."|Ongoing during 10 months treatment period|The Safety population consists of all randomized subjects who received at least one dose of the study drug. The subjects were included in the treatment group corresponding to the study drug they actually received.|||reactions|||Number
2568213|NCT02556801|Other Pre-specified|Number and Severity of Local Reactions|"The total number and severity (mild, moderate or severe) of local reactions (reported as TEAE) in the active treatment groups and placebo treatment group.~Intensity grading:~Mild: Awareness of symptoms but easily tolerated, no disruption of normal activities.~Moderate: Discomfort enough to cause interference with usual activity. Severe: Incapacitating with inability to work or do usual activity."|Ongoing during 10 months treatment period|The Safety population consists of all randomized subjects who received at least one dose of the study drug. The subjects were included in the treatment group corresponding to the study drug they actually received.|||reactions|||Number
2568214|NCT02556801|Secondary|Change From Baseline in Serum Specific Immunoglobulin (IgG4) Levels After 5 Months (Visit 4) and 10 Months (Visit 6) of Treatment|Changes from baseline in serum specific immunoglobulin levels (IgG4 ATG, IgG4 AP1 and IgG4 AP5) after 5 months of treatment (Visit 4) and after 10 months of treatment (Visit 6). Measurements at visit 1 will be used as baseline.|5 and 10 months after treatment start compared to first day of treatment (IgG4 at baseline measured at Visit 2, before IMP injection)|The Intention-to-Treat population (ITT) consists of all randomized subjects who received at least one dose of the study drug and for whom at least one post-baseline measurement for the primary efficacy endpoint was available.|||Geometric Mean fold change||95% Confidence Interval|Geometric Mean
2568215|NCT02556801|Secondary|Change From Baseline in Serum Specific Immunoglobulin (IgG) Levels After 5 Months (Visit 4) and 10 Months (Visit 6) of Treatment|Changes from baseline in serum specific immunoglobulin levels (IgG ATG, IgG AP1 and IgG AP5) after after 5 months of treatment (Visit 4) and after 10 months of treatment (Visit 6). Measurements at visit 1 will be used as baseline.|5 and 10 months after treatment start compared to first day of treatment (IgG at baseline measured at Visit 2, before IMP injection)|The Intention-to-Treat population (ITT) consists of all randomized subjects who received at least one dose of the study drug and for whom at least one post-baseline measurement for the primary efficacy endpoint was available.|||Geometric Mean fold change||95% Confidence Interval|Geometric Mean
2568216|NCT02556801|Secondary|Change From Baseline in Serum Specific Immunoglobulin (IgE) Levels After 5 Months (Visit 4) and 10 Months (Visit 6) of Treatment|Changes from baseline in serum specific immunoglobulin levels (IgE) after after 5 months of treatment (Visit 4) and after 10 months of treatment (Visit 6). Measurements at visit 1 will be used as baseline.|5 and 10 months after treatment start compared to first day of treatment (IgE at baseline measured at Visit 2, before IMP administration)|The Intention-to-Treat population (ITT) consists of all randomized subjects who received at least one dose of the study drug and for whom at least one post-baseline measurement for the primary efficacy endpoint was available.|||Geometric Mean fold change||95% Confidence Interval|Geometric Mean
2568217|NCT02556801|Secondary|Mean Combined Symptom and Medication Scores (CSMS) During the Grass Pollen Season.|The mean CSMS will be calculated as an average of all non-missing daily CSMS during the grass pollen season. Subjects that did not complete at least 75% of their diary data, and subjects who have been on holidays outside the region for more than 7 days during the actual grass pollen season will be excluded from the analysis. The daily CSMS will be computed according to the definition given by the EAACI Position Paper. The actual grass pollen season would start on the first of 3 consecutive days that have a grass pollen count ≥ 10 ppm3 per 24 hours and the season would end on the first of 3 consecutive days that have a grass pollen count < 10 ppm3 per 24 hours. The defined pollen season could consist of several separate periods that comply with this definition. The CSMS has a range from 0 to 6 and the higher the score, the more severe symptoms a subject is experiencing.|during the grass pollen season: estimated between 6 and 10 months after start of treatment at Visit 2|The Intention-to-Treat population (ITT) consists of all randomized subjects who received at least one dose of the study drug and for whom at least one post-baseline measurement for the primary efficacy endpoint was available.|||mean Combined Symptom Medication Score||Standard Error|Least Squares Mean
2568218|NCT02556801|Secondary|Change From Baseline in Mean Total Nasal Symptom Score (TNSS) After 5 Months of Treatment (Visit 4)|The change from baseline of the mean TNSS at visit 4. The mean TNSS at visit 4 will be calculated as an average of all non-missing TNSS between 1 and 6 hours after start of Environmental Exposure Chamber (EEC) challenge at visit 4. The baseline will be calculated as an average of all non-missing TNSS between 1 and 6 hours after start of during EEC challenge at visit 2. TNSS will be computed as the sum of individual scores for four nasal symptoms (running nose, congestion, itchy nose, and sneezing). Each of the four symptoms will be rated on a scale of 0-3 as follows: 0, none; 1, mild; 2, moderate; and 3, severe. The range of TNSS is from 0 to 12 units on a scale. The highest the score, the more severe symptoms a subject experiences. Negative change of TSS between baseline and visit 6 was expected (reduced symptoms), more negative change at visit 4 versus baseline represents better outcome of the study.|5 months after treatment start compared to first day of treatment (TSS at baseline measured at Visit 2, before IMP injection)||||mean Total Nasal Symptom Score||Standard Error|Least Squares Mean
2568219|NCT02556801|Secondary|Change From Baseline in Mean Total Nasal Symptom Score (TNSS) After 10 Months of Treatment (Visit 6)|The change from baseline of the mean TNSS at visit 6. The mean TNSS at visit 6 will be calculated as an average of all non-missing TNSS between 1 and 6 hours after start of EEC challenge at visit 6. The baseline will be calculated as an average of all non-missing TNSS between 1 and 6 hours after start of Environmental Exposure Chamber (EEC) challenge at visit 2. TNSS will be computed as the sum of individual scores for four nasal symptoms (running nose, congestion, itchy nose, and sneezing). Each of the four symptoms will be rated on a scale of 0-3 as follows: 0, none; 1, mild; 2, moderate; and 3, severe. The range of TNSS is from 0 to 12 units on a scale. The highest the score, the more severe symptoms a subject experiences.Negative change of TNSS between baseline and visit 6 was expected (reduced symptoms), more negative change at visit 6 versus baseline represents better outcome of the study.|10 months after treatment start compared to first day of treatment (TSS at baseline measured at Visit 2, before IMP injection)||||mean Total Nasal Symptom Score||Standard Error|Least Squares Mean
2568220|NCT02556801|Secondary|Change From Baseline in Mean Total Symptom Score (TSS) After 5 Months of Treatment (Visit 4)|The change from baseline of the mean TSS at visit 4. The mean TSS at visit 4 will be calculated as an average of all non-missing TSS between 1 and 6 hours after start of Environmental Exposure Chamber (EEC) challenge at visit 4. The baseline will be calculated as an average of all non-missing TSS between 1 and 6 hours after start of EEC challenge at visit 2. The range of TSS is from 0 to 24 units on a scale. The highest the score, the more severe symptoms a subject experiences. Negative change of TSS between baseline and visit 4 was expected (reduced symptoms), more negative change at visit 4 versus baseline represents better outcome of the study.The highest the score, the more severe symptoms a subject experiences.|5 months after treatment start compared to first day of treatment (TSS at baseline measured at Visit 2, before IMP administration)|The Intention-to-Treat population (ITT) consists of all randomized subjects who received at least one dose of the study drug and for whom at least one post-baseline measurement for the primary efficacy endpoint was available.|||mean Total Symptom Score||Standard Error|Least Squares Mean
2568221|NCT02556801|Secondary|Change From Baseline in Mean Total Symptom Score (TSS) After 10 Months of Treatment (Visit 6)|The change from baseline of the mean TSS at visit 6. The baseline will be calculated as an average of all non-missing TSS scores between 1 and 6 hours after start of Environmental Exposure Chamber (EEC) challenge at visit 2. The range of TSS is from 0 to 24 units on a scale. The highest the score, the more severe symptoms a subject experiences. Negative change of TSS between baseline and visit 6 was expected (reduced symptoms), more negative change at visit 6 versus baseline represents better outcome of the study.|10 months after treatment start compared to first day of treatment (TSS at baseline measured at Visit 2, before IMP administration)|The Intention-to-Treat population (ITT) consists of all randomized subjects who received at least one dose of the study drug and for whom at least one post-baseline measurement for the primary efficacy endpoint was available.|||mean Total Symptom Score||Standard Error|Least Squares Mean
2568222|NCT02556801|Primary|Mean Total Symptom Score (TSS) After 10 Months of Treatment (Visit 6) Compared to Placebo|The primary endpoint was the TSS after 10 months of treatment (at visit 6). The mean TSS at visit 6 was calculated as an average of all non-missing TSS scores between 1 and 6 hours after start of Environmental Exposure Chamber (EEC) challenge at visit 6. TSS was computed as the sum of individual scores for eight nasal and non-nasal symptoms (rhinorrhea, congestion, sneezing, itchiness, itchy/gritty eyes, tearing/watery eyes, red/burning eyes, and ear/palate itching). Each of eight symptoms was rated on a scale of 0-3 as follows: 0, none; 1, mild; 2, moderate; 3, severe. The range of TSS is from 0 to 24 units on a scale. The highest the score, the more severe symptoms a subject experiences. Negative change of TSS between baseline and visit 6 was expected (reduced symptoms), more negative change at visit 6 versus baseline represents better outcome of the study.|10 months after treatment start (baseline - Visit 2)|The Intention-to-Treat population (ITT) includes all randomized subjects who received at least one dose of the study drug and for whom at least one post-baseline measurement for the primary efficacy endpoint was available.|||Score on a scale||Standard Error|Least Squares Mean
2568787|NCT02550132|Primary|Vertebral Displacement of the Sixth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
2568223|NCT02556788|Primary|Investigator Global Assessment (IGA) Score of 1 (Almost Clear) or 0 (Clear)|Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (Clear) and at least a 2-grade improvement from Baseline to Week 12.|From Baseline to Week 12||||Participants|||Count of Participants
2568224|NCT02556632|Primary|Change in the Severity of Skin Reactions Using the Radiation Dermatitis Scale (RDS). Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration)|"The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions after completion of RT.~The RDS score ranges from 0-4 with higher scores indicating worse outcome."|Baseline to up to 1 week after completion of radiation therapy|Note: Of the 64 who were randomized to Arm 1, 60 completed 1-week post; of the 65 who were randomized to Arm II, 58 completed 1-week post; of the 62 who were randomized to Arm III, 52 completed 1-week post.|||units on a scale||Standard Deviation|Mean
2568225|NCT02556632|Primary|Incidence of Moist Desquamation (Present vs. Absent)|The degree to which each topical intervention decreases the incidence of moist desquamation will be examined using Fisher's exact test. Each agent's potential as a preventative intervention will be determined through comparison of the proportion of subjects with no to minimal radiation dermatitis within each arm using Fisher's exact test.|Baseline up to completion of radiation therapy|Note: Of the 64 who were randomized to Arm 1, 59 completed the study; of the 65 who were randomized to Arm II, 59 completed the study; of the 62 who were randomized to Arm III, 53 completed the study|||Participants|||Count of Participants
2568226|NCT02556632|Primary|Mean Radiation Dermatitis Severity (RDS) Score. Range: 0 (no Dermatitis) - 4 (Violaceous Erythema With Diffuse Desquamation Occurring in Sheets; Patchy Crusting; Superficial Ulceration)|"The mean 1 week post-RT RDS score for each arm will be compared using ANOVA to determine if the topical interventions reduce the severity of skin reactions at the end of RT.~The RDS score ranges from 0-4 with higher scores indicating worse outcome."|Baseline up to 1 week post radiation therapy|Note: Of the 64 who were randomized to Arm 1, 59 completed the study; of the 65 who were randomized to Arm II, 59 completed the study; of the 62 who were randomized to Arm III, 53 completed the study|||units on a scale||Standard Deviation|Mean
2568227|NCT02556333|Primary|HIV RNA Change From Baseline to Day 10|An HIV RNA decline of >=0.5 log by day 10 will be considered to be an adequate virologic response, to proceed to the second phase of the study.|10 days|One patient with multiple drug resistant HIV infection enrolled into this study.|||log HIV RNA copies/mL|||Number
2568228|NCT02556307|Secondary|Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin||Up to 99.6 Weeks|All treated participants were included.|||weeks||Standard Deviation|Mean
2568229|NCT02556307|Secondary|Hemoglobin Values||Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)|"Number of participants analyzed=treated participants with data available for hemoglobin. Here, n specifies number of participants with data available for specified category."|||gram per liter||Standard Deviation|Mean
2568230|NCT02556307|Secondary|Leukocyte Values||Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)|"Number of participants analyzed=treated participants with data available for leukocyte value. Here, n specifies number of participants with data available for specified category."|||billion cells per liter||Standard Deviation|Mean
2568231|NCT02556307|Secondary|Thrombocyte Values||Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)|"Number of participants analyzed=treated participants with data available for thrombocyte value. Here, n specifies number of participants with data available for specified category."|||billion cells per liter||Standard Deviation|Mean
2568232|NCT02556307|Secondary|HCV RNA Values||Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)|"Number of participants analyzed=treated participants with data available for HCV RNA. Here, n specifies number of participants with data available for specified category."|||IU/mL||Standard Deviation|Mean
2568233|NCT02556307|Secondary|Percentage of Participants With Undetectable HCV RNA|Undetectable HCV RNA=a single last HCV RNA <20 IU/mL|Weeks 4, 12 and at end of treatment (up to 99.6 weeks)|All treated participants were included in the analysis.|||percentage of participants|||Number
2568234|NCT02556307|Primary|Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment|SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment).|6 months after the last study drug administration (up to 123.6 weeks)|All treated participants were included in the analysis. Here, 'n' specifies the number of participants included in the analysis as per the specified category (genotype or previous treatment).|||percentage of participants|||Number
2568235|NCT02556255|Post-Hoc|Number of Lesions With Post-intervention Residual Diameter Stenosis of ≤30% With Adjunctive Therapy Assessed by Fluoroscopic Angiography in Cases Where Adjunctive Therapy is Medically Applicable|EX-PAD-01 study secondary efficacy endpoint of the post adjunctive therapy residual diameter stenosis, was set per protocol with a threshold at <30%, however, in many other atherectomy studies, this threshold is set at ≤30%, Therefore results with this threshold are presented as well|Intraoperative (at the end of the index procedure, after the last adjunctive therapy, e.g. last balloon or last stent)|This endpoint is analyzed for lesions (53) and not for participants (50)|||lesions|lesions||Count of Units
2568248|NCT02556203|Secondary|Number of Participants With Cardiovascular Death or Thromboembolic Event|Composite of CV-death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism (per adjudication).|Through study completion, on average 16 months|Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).|||Participants|||Count of Participants
2568467|NCT02554279|Secondary|Number of Oocytes Retrieved||At oocyte retrieval visit (approximately 36 hours after hCG administration)|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product. The number of participants analyzed represent the participants with oocytes retrieved.|||oocytes||Standard Deviation|Mean
2568236|NCT02556255|Secondary|Change in Grade of Walking Impairment Questionnaire (WIQ) Post B-Laser™ Device Procedure Compared to Baseline|"Change in Grade of Walking Impairment Questionnaire (WIQ) Post B-Laser™ Device Procedure Compared to Baseline. WIQ score ranges from 0-100 with higher score indicating a better walking outcomes.~The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent increases while negative results represent decrease, so higher WIQ score at the later time point represents an improvement through time and vice versa."|baseline and 30 days, 6 months and 12 months post procedure|"The number analyzed in one or more rows differs from overall number since it excludes missing data at different time-points.~Answers to all questions in the Walking Impairment Questionnaire (WIQ) must be provided to obtain a valid result, incomplete questionnaires were not considered."|||score on a scale||Standard Deviation|Mean
2568237|NCT02556255|Secondary|Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline|"Change in Rutherford Classification Post B-Laser™ Device Procedure Compared to Baseline.~Rutherford Classification has seven stages, from Stage 0 to Stage 6, when the lower value indicate a better outcome: 0= Asymptomatic; 1= Mild claudication; 2= Moderate claudication; 3= Severe claudication; 4= Rest pain; 5= Ischemic ulceration not exceeding ulcer of the digits of the foot; 6= Severe ischemic ulcers or frank gangrene.~The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent decrease while negative results represent increases, so lower Rutherford score at the later time point represents an improvement through time and vice versa."|baseline and 30 days, 6 months and 12 months post procedure|The number analyzed in one or more rows differs from overall number since it excludes missing data at different time-points|||Participants|||Count of Participants
2568238|NCT02556255|Secondary|Change in Ankle-Brachial Index (ABI) Post B-Laser™ Device Procedure Compared to Baseline|"Change in Ankle-Brachial Index (ABI) post B-Laser™ device procedure compared to baseline.~ABI is calculated as the ratio of the ankle blood pressure to the arm blood pressure. The normal value ranges between 0.9 to 1.3.~The change is calculated as the value at the later time point minus the value at the earlier time point, when positive results represent increases while negative results represent decrease, so higher ABI score at the later time point represents an improvement through time and vice versa."|baseline and 30 days, 6 months and 12 months post procedure|The number analyzed in one or more rows differs from overall number since it excludes missing data at different time-points|||ratio||Standard Deviation|Mean
2568239|NCT02556255|Secondary|Number of Lesions With Post-intervention Residual Diameter Stenosis of <30% With Adjunctive Therapy Assessed by Fluoroscopic Angiography in Cases Where Adjunctive Therapy is Medically Applicable|The ability of the B-Laser™ catheter to achieve a post-intervention residual diameter stenosis of <30% with adjunctive therapy assessed by fluoroscopic angiography in cases where adjunctive therapy is medically applicable|Intraoperative (at the end of the index procedure, after the last adjunctive therapy, e.g. last balloon or last stent)|This endpoint is analyzed for lesions (53) and not for participants (50)|||lesions|lesions||Count of Units
2568240|NCT02556255|Secondary|Number of Participants With 30 Day Freedom From Device/Procedure* Related Adverse Events|"(*NOTE: Device- or Procedure-related AE Refers Only to the ATHERECTOMY PROCEDURE (With B-Laser™) and Not the Entire Index Procedure.)~Clinically Significant Dissections requiring intervention~Clinically Significant Embolus requiring intervention~Clinically Pseudo-aneurysm requiring intervention"|30 days post procedure||||Participants|||Count of Participants
2568241|NCT02556255|Secondary|Number of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (2)|"(*NOTE: Device- or Procedure-related AE Refers Only to the ATHERECTOMY PROCEDURE (With B-Laser™) and Not the Entire Index Procedure.)~Emboli, defined as a new occlusion of any visualized runoff vessel which cannot be reversed with an intravascular vasodilator~Flow limiting dissection"|Perioperative (until discharge), an average of 6 days||||Participants|||Count of Participants
2568242|NCT02556255|Primary|Number of Lesions With Technical Success Rate: the Ability of the B-Laser™ Catheter to Cross the Target Lesion Stenosis Over the Wire.|The technical success will be evaluated visually by the performing physician during procedure by fluoroscopy. It is evaluated per lesion and not per subject|Intraoperative (during the index procedure, after B-Laser™ catheter crossing, before adjunctive therapy)|Generally angiographic outcomes are evaluated per lesions (53) and not per participants (50). Yet, this specific endpoint is analyzed for 52 lesions (instead of 53), since the data for this timepoint in one participant with one lesion was missing for evaluation of this specific endpoint.|||lesions|lesions||Count of Units
2568243|NCT02556255|Primary|Number of Participants With Perioperative (Until Discharge) Freedom From Device/Procedure* Related Adverse Events (1)|"(*NOTE: Device- or procedure-related AE refers only to the ATHERECTOMY PROCEDURE (with B-Laser™) and not the entire index procedure.)~Clinically Significant Perforations requiring intervention~Clinically Significant Dissections requiring intervention~Clinically Significant Embolus requiring intervention~Clinically Pseudo-aneurysm requiring intervention"|Perioperative (until discharge), an average of 6 days||||Participants|||Count of Participants
2568244|NCT02556255|Primary|Number of Participants With 30 Day Freedom From Major Adverse Events|"Need for emergency surgical revascularization of the target limb~Unplanned target limb amputation above the ankle~Clinically driven Target Lesion Revascularization (TLR)~Cardiovascular related deaths"|30 days post procedure||||Participants|||Count of Participants
2568245|NCT02556203|Secondary|Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds|Composite of BARC 2,3 or 5 bleedings|Through study completion, on average 16 months|Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).|||Participants|||Count of Participants
2568246|NCT02556203|Secondary|Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds|ISTH major bleeds|Through study completion, on average 16 months|Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).|||Participants|||Count of Participants
2568247|NCT02556203|Secondary|Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds|Composite of TIMI major and minor bleedings|Through study completion, on average 16 months|Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).|||Participants|||Count of Participants
2568249|NCT02556203|Secondary|Number of Participants With Net-clinical Benefit|The net-clinical-benefit defined as the adjudicated composite of all-cause death, any stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep vein thrombosis, non-CNS systemic embolism (efficacy); VARC life-threatening, disabling and VARC major bleeds (safety).|Through study completion, on average 16 months|Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).|||Participants|||Count of Participants
2568250|NCT02556203|Primary|Number of Participants With Primary Bleeding Event (PBE)|PBE is defined according to VARC (Valve Academic Research Consortium) definitions as the adjudicated composite of: Life-threatening, disabling or major bleeding.|Through study completion, on average 16 months|Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).|||Participants|||Count of Participants
2568251|NCT02556203|Primary|Number of Participants With Death or First Thromboembolic Event (DTE)|Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism.|Through study completion, on average 16 months|Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall)|||Participants|||Count of Participants
2568252|NCT02556203|Primary|Number of Participants With Death or First Thromboembolic Event (DTE)|Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism.|Through study completion, on average 14 months|Safety analysis set (SAF): Included all randomized subjects who had been exposed to study drug at least once (1608 subjects overall).|||Participants|||Count of Participants
2568253|NCT02556177|Primary|Neuropsychological Assessments|Neuropsychological assessments collected from subjects who completed the study.|Per patient scanning over 3 months||||Neuropsychological assessments|||Number
2568254|NCT02556177|Primary|MRI Image Data Sets|MRI image data sets collected from subjects who completed the study.|Per patient scanning over 3 months||||Images collected|||Number
2568255|NCT02556138|Secondary|Mean Percentage of Excess Weight Loss (%EWL) After Balloon Removal|The percentage of excess weight loss (%EWL) is a common metric for reporting weight loss after bariatric surgery. The %EWL can vary depending on the definitions of ideal body weight (IBW) used and the preoperative weight.|6 months|Intent to treat analysis|||percentage of weight loss||Standard Deviation|Mean
2568256|NCT02556138|Secondary|Mean Percentage of Total Body Weight Loss (%TBWL) After Balloon Removal|%TBWL at 6 months = Number of kg lost at 6 months/starting weight in kg|6 months|Intent to treat analysis|||percentage of weight loss||Standard Deviation|Mean
2568257|NCT02556138|Primary|Number of Subjects With >= 15% Excess Body Weight Loss at 6 Months|The percentage of excess weight loss (%EWL) is a common metric for reporting weight loss after bariatric surgery. The %EWL can vary depending on the definitions of ideal body weight (IBW) used and the preoperative weight.|6 months|Intent to treat analysis|||Participants|||Count of Participants
2568258|NCT02555878|Secondary|Percentage of Participants With Time to the First Occurrence of Any Bleeding|Percentage of participants with time to the first occurrence of any bleeding event was reported. Any bleeding is defined as a composite of major bleeding, clinically relevant non-major bleeding, or minor bleeding.|From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)|The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2568259|NCT02555878|Secondary|Percentage of Participants With Time to the First Occurrence of Minor Bleeding|Percentage of participants with time to the first occurrence of minor bleeding was reported. Minor bleeding (that is, minimal bleeding) is defined as overt bleeding episodes not meeting the criteria for major or clinically relevant non-major bleeding event.|From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)|The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2568260|NCT02555878|Secondary|Percentage of Participants With Time to the First Occurrence of Clinically Relevant Non-major Bleeding|Percentage of participants with time to the first occurrence of clinically relevant non-major bleeding was reported. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, or unscheduled contact with a physician, or temporary cessation of study treatment, or discomfort such as pain, or impairment of activities of daily life.|From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)|The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2568261|NCT02555878|Secondary|Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 4|Percentage of participants with time to first occurrence of composite efficacy endpoint 4 (composite of objectively confirmed symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, VTE-related deaths or major bleeding events up to Day 180) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.|Up to Day 180|The ITT population consisted of all randomized participants.|||Percentage of participants|||Number
2568262|NCT02555878|Secondary|Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 3|Percentage of participants with time to first occurrence of composite efficacy endpoint 3 (composite of objectively confirmed symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, asymptomatic lower extremity proximal DVT, symptomatic non-fatal PE, incidental PE, VTE-related deaths, fatal/non-fatal ATE [MI, stroke {ischemic infarction with or without hemorrhagic conversion or primary hemorrhagic events - intraparenchymal hemorrhage, subdural hematoma or epidural hematoma} or any ATE] or fatal/non-fatal visceral VTE) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.|Up to Day 180|The ITT population consisted of all randomized participants.|||Percentage of participants|||Number
2568480|NCT02553928|Primary|Adverse Events|Number of patients who reported adverse events|baseline to week 16 (end of study)|All patients treated|||Participants|||Count of Participants
2568263|NCT02555878|Secondary|Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 2|Percentage of participants with time to first occurrence of composite efficacy endpoint 2 (composite of objectively confirmed symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE or VTE-related deaths) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.|Up to Day 180|The ITT population consisted of all randomized participants.|||Percentage of participants|||Number
2568264|NCT02555878|Secondary|Percentage of Participants With Time to the First Occurrence of Composite Efficacy Endpoint 1|Percentage of participants with time to first occurrence of composite efficacy endpoint 1 (composite of objectively confirmed symptomatic and asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, incidental PE or all-cause mortality) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.|Up to Day 180|The ITT population consisted of all randomized participants.|||Percentage of participants|||Number
2568265|NCT02555878|Secondary|Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Visceral VTE|Percentage of participants with time to the first occurrence of fatal or non-fatal visceral VTE as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.|Up to Day 180|The ITT population consisted of all randomized participants.|||Percentage of participants|||Number
2568266|NCT02555878|Secondary|Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Arterial Thromboembolic Events (ATE)|Percentage of participants with time to first occurrence of fatal/non-fatal ATE (a composite of occurrence of myocardial infarction (MI), stroke [ischemic infarction with or without hemorrhagic conversion or primary hemorrhagic events - intraparenchymal hemorrhage, subdural hematoma or epidural hematoma] or any other ATE recorded) event as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.|Up to Day 180|The ITT population consisted of all randomized participants.|||Percentage of participants|||Number
2568267|NCT02555878|Secondary|Percentage of Participants With All-Cause Mortality|Percentage of participants with all-cause mortality as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported. Overall deaths occurred during observation period (defined by start to end date of the observation period [that is approximately 180 days] are reported here.|Up to Day 180|The ITT population consisted of all randomized participants.|||Percentage of participants|||Number
2568268|NCT02555878|Secondary|Percentage of Participants With Time to the First Occurrence of Symptomatic VTE Events or VTE-Related Deaths|Percentage of participants with time to first occurrence of the composite endpoint of symptomatic VTE events (symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, or symptomatic non-fatal PE) or VTE related deaths as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.|Up to Day 180|The ITT population consisted of all randomized participants.|||Percentage of participants|||Number
2568269|NCT02555878|Primary|Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH)|Major bleeding is defined as clinically overt bleeding that is associated with a reduction in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or occurrence at a critical site defined as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal, or fatal outcome.|From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)|The safety analysis population consisted of all randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2568270|NCT02555878|Primary|Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components)|Percentage of participants with time to the first occurrence of primary efficacy endpoint (composite and components) was reported. The primary efficacy composite endpoint is time to first occurrence of objectively confirmed symptomatic and asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, incidental PE, or VTE-related death as adjudicated by an independent blinded Clinical Endpoint Committee (CEC).|Up to Day 180|The Intent-to-treat (ITT) population consisted of all randomized participants.|||Percentage of participants|||Number
2568271|NCT02555722|Secondary|Ease of Insertion and Removal - Enfilcon A Lens (Control)|Ease of Insertion (EOI) and removal (EOR) was assessed. Subjects were asked to rate ease of insertion and removal on scale 0-5 (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, or 5=unmanageable.|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|"All sites, control completed subjects' eyes. Three subjects data was not collected during Week 1 visit. One subject data was not collected during Month 2 visit.~Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3."|||Eyes|Eyes||Count of Units
2568272|NCT02555722|Secondary|Ease of Insertion and Removal - Fanfilcon A Lens (Test)|Ease of Insertion (EOI) and removal (EOR) was assessed. Subjects were asked to rate ease of insertion and removal on scale 0-5 (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, or 5=unmanageable.|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|"All sites, test subjects' completed eyes. One subject data was not collected at 2 week visit.~Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3."|||eyes|eyes||Count of Units
2568273|NCT02555722|Secondary|Overall Vision Quality - Enfilcon A Lens (Control)|Overall vision quality (OVQ) and vision at night (VAN) is assessed at the specific time points. Subjects were asked to rate vision from 0-5, (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, 5= unacceptable).|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|"All sites, control completed subjects. Three subjects data was not collected during Week 1 visit. One subject data was not collected during Month 2 visit.~Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3."|||eyes|eyes||Count of Units
2568274|NCT02555722|Secondary|Overall Vision Quality - Fanfilcon A Lens (Test)|Overall vision quality (OVQ) and vision at night (VAN) is assessed at the specific time points. Subjects were asked to rate vision from 0-5, (0=excellent, 1=very good, 2=good, 3=poor, 4=very poor, 5= unacceptable).|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|"All sites, test subjects' completed. One subject data was not collected at 2 week visit.~Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3."|||eyes|eyes||Count of Units
2568275|NCT02555722|Secondary|Comfort - Enfilcon A Lens (Control)|Enfilcon A lens (control) are assessed regarding comfort for the following: comfort upon insertion (CUI), comfort during the day (CDD), end of the day comfort (EDC), overall comfort (OC), and comfort at visit (CV). Subjects were asked to rate comfort from 0-5 (0=excellent, 1=very comfortable, 2=comfortable, 3=slightly uncomfortable, 4=very uncomfortable, or 5=causes pain).|Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months follow-up|"All sites, control completed subjects. Three subjects data was not collected during Week 1 visit. One subject data was not collected during Month 2 visit.~Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3."|||eyes|eyes||Count of Units
2568276|NCT02555722|Secondary|Comfort - Fanfilcon A Lens (Test)|Fanfilcon A lens (test) are assessed regarding comfort for the following: comfort upon insertion (CUI), comfort during the day (CDD), end of the day comfort (EDC), overall comfort (OC), and comfort at visit (CV). Subjects were asked to rate comfort from 0-5 (0=excellent, 1=very comfortable, 2=comfortable, 3=slightly uncomfortable, 4=very uncomfortable, or 5=causes pain).|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|"All sites, test subjects' completed eyes. One subject data was not collected at 2 week visit.~Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3."|||Eyes|Eyes||Count of Units
2568277|NCT02555722|Primary|Average Wearing Time - Enfilcon A Lens (Control)|Average lens wearing time for enfilcon A lens (control) measured in hours.|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|All sites, control completed subjects' eyes. Three subjects data was not collected during Week 1 visit. One subject data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.|||hours||Standard Deviation|Mean
2568278|NCT02555722|Primary|Average Wearing Time - Fanfilcon A Lens (Test)|Average lens wearing time for fanfilcon A lens (test) measured in hours.|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|All sites, test subjects' completed eyes. One subject data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.|||hours||Standard Deviation|Mean
2568279|NCT02555722|Primary|Visual Acuity - Enfilcon A Lens (Control)|Visual acuity is assessed for enfilcon A lens (control) using Snellen chart.|Week 1, Week 2, Month 1, Month 2, Month 3|All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit.|||eyes|Eyes||Number
2568280|NCT02555722|Primary|Visual Acuity - Fanfilcon A Lens (Test)|Visual acuity is assessed for fanfilcon A lens (test) using Snellen chart.|Week 1, Week 2, Month 1, Month 2, Month 3|All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit.|||eyes|Eyes||Number
2568281|NCT02555722|Primary|Palpebral Conjunctiva - Enfilcon A Lens (Control)|Palpebral conjunctiva is assessed for enfilcon A lens (control). Grading scale: absent/present|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.|||percentage of eyes|Eyes||Number
2568282|NCT02555722|Primary|Palpebral Conjunctiva - Fanfilcon A Lens (Test)|Palpebral conjunctiva is assessed for fanfilcon A lens (test). Grading scale: Absent/present|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.|||percentage of eyes|Eyes||Number
2568283|NCT02555722|Primary|Bulbar Hyperemia - Enfilcon A Lens (Control)|Bulbar hyperemia is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.|||percentage of eyes|Eyes||Number
2568284|NCT02555722|Primary|Bulbar Hyperemia - Fanfilcon A Lens (Test)|Bulbar hyperemia is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.|||percentage of eyes|Eyes||Number
2568285|NCT02555722|Primary|Limbal Hyperemia - Enfilcon A Lens (Control)|Limbal hyperemia is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|All sites, control completed subjects' eyes Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.|||percentage of eyes|Eyes||Number
2568286|NCT02555722|Primary|Limbal Hyperemia - Fanfilcon A Lens (Test)|Limbal hyperemia is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.|||percentage of eyes|Eyes||Number
2568287|NCT02555722|Primary|Corneal Staining - Enfilcon A Lens (Control)|Corneal staining with fluorescein is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe; Grading regions: S - Superior, T - Temporal, C - Central, N - Nasal, I - Inferior;|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.|||percentage of eyes|Eyes||Number
2568327|NCT02555228|Secondary|Volume of Additional Manual Flushes Required During Endoscopy in Mls|The volume of additional water (in mls) flushed during the gastroscopy in order to remove obscuring foam or bubbles.|This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.||||mls||Standard Deviation|Mean
2568288|NCT02555722|Primary|Corneal Staining - Fanfilcon A Lens (Test)|Corneal staining with fluorescein is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe; Grading regions: S - Superior, T - Temporal, C - Central, N - Nasal, I - Inferior;|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3|||percentage of eyes|Eyes||Number
2568289|NCT02555722|Primary|Corneal Vascularization - Enfilcon A Lens (Control)|Corneal vascularization is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|All sites, control completed subjects' eyes. Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.|||percentage of eyes|Eyes||Number
2568290|NCT02555722|Primary|Corneal Vascularization - Fanfilcon A Lens (Test)|Corneal vascularization is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.|||percentage of eyes|Eyes||Number
2568291|NCT02555722|Primary|Corneal Infiltrates - Enfilcon A Lens (Control)|Corneal infiltrates is assessed for enfilcon A lens (control). Grading scale: absent/present|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|All sites, control completed subjects' eyes Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.|||percentage of eyes|Eyes||Number
2568292|NCT02555722|Primary|Corneal Infiltrates - Fanfilcon A Lens (Test)|Corneal infiltrates is assessed for fanfilcon A lens (test). Grading scale: Absent/present|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.|||percentage of eyes|Eyes||Number
2568293|NCT02555722|Primary|Stromal Edema - Enfilcon A Lens (Control)|Stromal edema is assessed for enfilcon A lens (control). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|All sites, control completed subjects' eyes Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.|||percentage of eyes|Eyes||Number
2568294|NCT02555722|Primary|Stromal Edema - Fanfilcon A Lens (Test)|Stromal edema is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected during at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.|||percentage of eyes|Eyes||Number
2568295|NCT02555722|Primary|Epithelial Edema - Enfilcon A Lens (Control)|Epithelial edema is assessed for enfilcon A lens (control). Grading scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|All sites, control completed subjects' eyes Three subjects (6 eyes) data were not collected during Week 1 visit. One subject (2 eyes) data was not collected during Month 2 visit. Unscheduled visits included: 2 subjects visiting between weeks 1 and 2, and one subject visiting between months 2 and 3.|||percentage of eyes|Eyes||Number
2568296|NCT02555722|Primary|Epithelial Edema - Fanfilcon A Lens (Test)|Epithelial edema is assessed for fanfilcon A lens (test). Grading Scale 0-4, 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|All sites, test subjects' completed eyes. One subject (2 eyes) data was not collected at 2 week visit. Unscheduled visits included one subject visiting between week 2 and 1 month visit and one subject visiting between months 2 and 3.|||percentage of eyes|Eyes||Number
2568297|NCT02555631|Secondary|Number of Participants That Participated in Each Session|this is measured by direct observation at selected sessions; report by the lifestyle coach; and discussion during focus groups at the end of the 16 weeks|16 weeks||||Participants|||Number
2568298|NCT02555631|Secondary|Number of Sessions Attended|with a measured goal of at least attendance observed and recorded at 9/16 sessions on average|16 weeks||||Sessions Attended||Standard Deviation|Mean
2568299|NCT02555631|Secondary|Number of Men Enrolled During 8 Weeks of Recruitment|measured by numbers of men and the timeframe in which the recruitment takes place;|8 weeks||||Participants|||Count of Participants
2568300|NCT02555631|Primary|Change in Weight in Pounds|the goal is to lose 5-7% of baseline body weight for pre-diabetic men|Baseline, 16 weeks||||percentage of body weight lost||Full Range|Mean
2568301|NCT02555618|Secondary|Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs|The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.|22 Days|Safety Analysis Set included all participants who received vaccination with study vaccine.|||percentage of participants|||Number
2568302|NCT02555618|Secondary|Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)|Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|22 days|Safety Analysis Set included all participants who received vaccination with study vaccine.|||percentage of participants|||Number
2568303|NCT02555618|Secondary|Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)|Participants recorded solicited injection site and systemic adverse events in a Subject Diary. Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis. Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting.|22 Days|Safety Analysis Set included all participants who received vaccination with study vaccine.|||percentage of participants|||Number
2568304|NCT02555618|Secondary|Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen)|Geometric mean fold increase in SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||fold increase||95% Confidence Interval|Geometric Mean
2568305|NCT02555618|Secondary|Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen)|Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||percentage of participants||95% Confidence Interval|Number
2568306|NCT02555618|Secondary|GMT of SRH Antibody Titer (Vero-Derived Antigen)|GMT of SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||titer||95% Confidence Interval|Geometric Mean
2568307|NCT02555618|Secondary|Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen)|Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of >4 mm^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm^2 achieving a SRH antibody titer of ≥25 mm^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||percentage of participants||95% Confidence Interval|Number
2568308|NCT02555618|Secondary|Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen)|Geometric mean fold increase in HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.|Baseline and Day 22|FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||fold increase||95% Confidence Interval|Geometric Mean
2568309|NCT02555618|Secondary|Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen)|Seroprotection rate, defined as the percentage of participants with HI antibody titer ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||percentage of participants||95% Confidence Interval|Number
2568310|NCT02555618|Secondary|GMT of HI Antibody Titer (Vero-Derived Antigen)|GMT of HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||titer||95% Confidence Interval|Geometric Mean
2568311|NCT02555618|Secondary|Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen)|Seroconversion rate, defined as the percentage of participants with a Baseline HI antibody titer of ≥10 achieving a minimal 4-fold increase, or a Baseline HI antibody titer of <10 achieving a HI antibody titer of ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||percentage of participants||95% Confidence Interval|Number
2568312|NCT02555618|Secondary|Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen)|Geometric mean fold increase in SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||fold increase||95% Confidence Interval|Geometric Mean
2568313|NCT02555618|Secondary|Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen)|Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm^2, was measured by SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||percentage of participants||95% Confidence Interval|Number
2568314|NCT02555618|Secondary|GMT of SRH Antibody Titer (Egg-Derived Antigen)|GMT of SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||mm^2||95% Confidence Interval|Geometric Mean
2568315|NCT02555618|Secondary|Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen)|Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of >4 mm^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm^2 achieving a SRH antibody titer of ≥25 mm^2, as measured by single radial hemolysis (SRH) antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||percentage of participants||95% Confidence Interval|Number
2569355|NCT02543801|Secondary|Narcotic Consumption|Total amount of narcotics administered as calculated in oral morphine equivalent dose immediate post operatively up to 48 hours.|Starting immediately post operatively up to 48 hours||||morphine equivalents||Standard Deviation|Mean
2568316|NCT02555618|Secondary|Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen)|Geometric mean fold increase in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline.|Baseline and Day 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||fold increase||95% Confidence Interval|Geometric Mean
2568317|NCT02555618|Secondary|Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen)|Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||percentage of participants||95% Confidence Interval|Number
2568318|NCT02555618|Primary|Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)|Geometric mean titer (GMT) of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.|Days 1 and 22|FAS included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||titer||95% Confidence Interval|Geometric Mean
2568319|NCT02555618|Primary|Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)|"Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.~Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer <10."|Baseline and Day 22|Full Analysis Set (FAS) included all randomized participants who received vaccination with study vaccine. 1 participant in the TAK-850 group discontinued the study before completion of the specified final observation and is excluded.|||percentage of participants||95% Confidence Interval|Number
2568320|NCT02555371|Secondary|Percentage of Participants With Time to First Exacerbation Requiring Hospitalization or ED Visit in Part C|Exacerbations of asthma requiring hospitalization or ED visit were assessed. The analysis was performed from Cox Proportional Hazards Model with covariates of treatment group, region, exacerbations in the year prior to randomization (as an ordinal variable) and Baseline maintenance OCS therapy (OCS versus no OCS). Percentage of participants with an exacerbation over time and its 95% confidence intervals were estimated using Kaplan-Meier estimates|Weeks 12, 24, 36 and 52|Intent-to-Treat Population.|||Percentage of participants||95% Confidence Interval|Number
2568321|NCT02555371|Secondary|Percentage of Participants With 0.5 Point or More Increase in Asthma Control Questionnaire (ACQ)-5 Score From Baseline in Part C|The ACQ-5 is a five-item, self-completed questionnaire. Five questions (concerning nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheeze) enquire about the frequency and/or severity of symptoms over the previous week. The response ranges from zero (no impairment/limitation) to six (total impairment/ limitation) scale. Increase in score of >= 0.5 units from Baseline indicates decrease in asthma control. Baseline is the latest available assessment prior to first dose of double-blind treatment within Part C. Percentage of participants with a 0.5 point or more increase in ACQ-5 score from Baseline over time during the on-treatment period of Part C and its 95% confidence interval were estimated using Kaplan-Meier estimates.|Baseline and Weeks 12, 24, 36 and 52|Intent-to-Treat Population.|||Percentage of participants||95% Confidence Interval|Number
2568322|NCT02555371|Secondary|Ratio to Baseline in Blood Eosinophil Count in Part C|Blood samples were collected at specific time points to measure blood eosinophils level. Baseline was defined as the latest available assessment prior to first dose of double-blind treatment within Part C. Ratio to Baseline is defined as visit value divided by Baseline value and was analyzed using Mixed Model Repeated Measures with covariates of Baseline, region, exacerbations in the year prior to randomization (as an ordinal variable), Baseline maintenance oral corticosteroids (OCS) therapy (OCS versus no OCS), treatment and visit, plus interaction terms for visit by Baseline and visit by treatment group. The log transformation was applied to blood eosinophil counts prior to analysis. If a blood eosinophil count of zero was reported, a small value was added prior to log transforming the data. The dispersion measure used was log standard error.|Baseline and Weeks 12, 24, 36 and 52|Intent-to-Treat Population. Only those participants available at the specified time points were analyzed for each treatment and represented as n=X in category titles|||Ratio||Standard Error|Least Squares Mean
2568323|NCT02555371|Primary|Percentage of Participants With First Clinically Significant Exacerbation in Part C|Clinically significant exacerbation was defined as worsening of asthma which requires use of systemic corticosteroids (e.g., prednisone) for at least 3 days or a single intramuscular (IM) corticosteroid dose and/or hospitalization and/or emergency department (ED) visits. For participants on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required. Percentage of participants with clinically significant exacerbation over time during the on-treatment period of Part C and 95% confidence interval were estimated using Kaplan-Meier estimates. Intent-to-Treat Population includes all randomized participants who received at least one dose of double-blind study medication within Part C.|Weeks 12, 24, 36 and 52|Intent-to-Treat Population.|||Percentage of participants||95% Confidence Interval|Number
2568324|NCT02555306|Secondary|Change From Baseline in Central Subfield Thickness (CST) at Day 90.|Bioactivity measures include CST (μm) measured by SD-OCT. Bioactivity will be considered evident if a considerable decrease in CST is observed.|Baseline (Day1) and Day 90.||||microns||Standard Deviation|Mean
2568325|NCT02555306|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90.|"BCVA measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters, with a range of [0, 97] in ETDRS letters.~An increase in BCVA indicates an improvement in the best corrected vision."|Baseline (Day1) and Day 90.||||ETDRS letters||Standard Deviation|Mean
2568326|NCT02555228|Secondary|Adverse Events in Each Group Which May or May Not be Related to Simethicone Solution||Participants will be followed from ingestion of the premedication to the time of discharge from the endoscopy center, an estimated duration. of 3 hours||||number of events|||Number
2568328|NCT02555228|Secondary|Mucosal Visibility Score Per Area as Determined by Mc Nally Score:|"Area E: esophagus~Area D: duodenum~Area A: antrum and angularis~Area B: body and fundus~Mc Nally score per area:~Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured"|This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.||||units on a scale||Standard Deviation|Mean
2568329|NCT02555228|Primary|Total Cumulative Mucosal Visibility Score|"Total cumulative mucosal visibility score (TMVS) of all areas during the gastroscopy as determined by Mc Nally score:~Score of 1: no bubbles Score of 2: minimal-occasional bubbles; must actively look for them Score of 3: moderate-obviously present Score of 4: severe-so many bubbles that vision is obscured~Total areas covered:~(E) esophagus (D) duodenum (A) Antrum and angularis (B) body and fundus"|This will be calculated during the diagnostic gastroscopy, an expected duration of 10 minutes.||||units||Standard Deviation|Mean
2568330|NCT02555215|Secondary|Number of Participants Experiencing Disability Progression|Measured by at least a 1.0-point increase on the EDSS from baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from baseline EDSS = 0 that is sustained for 24 weeks.|Baseline to Week 96|Participants who received at least 1 dose of BG00012 in this study and had an evaluation of the efficacy endpoint under analysis.|||Participants|||Count of Participants
2568331|NCT02555215|Secondary|Change From Baseline in the Degree of Disability|The Expanded Disability Status Scale (EDSS) measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.|Baseline to Week 96|Participants who received at least 1 dose of BG00012 in this study and had an evaluation of the efficacy endpoint under analysis.|||score on a scale||Standard Deviation|Mean
2568332|NCT02555215|Secondary|Percentage of Participants Experiencing One or More Relapses|Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Investigator. New or recurrent neurologic symptoms that evolved gradually over months were considered disability progression, not an acute relapse, and were not treated with steroids.|Baseline to Week 96||||percentage of participants|||Number
2568333|NCT02555215|Secondary|Average Annualized Relapse Rate (ARR)|"Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Investigator. New or recurrent neurologic symptoms that evolved gradually over months were considered disability progression, not an acute relapse, and were not treated with steroids.~The ARR was calculated as the total number of relapses that occurred during the previous 12 months and during the 120 weeks on treatment for participants in Study 109MS202 that continued into Study 109MS311, divided by the total number of person-years followed prior to the study and by the total number of person-years followed during the study, respectively."|Baseline to Week 96|Participants who received at least 1 dose of BG00012 in this study and had an evaluation of the efficacy endpoint under analysis.|||relapses per person-years|||Number
2568334|NCT02555215|Secondary|Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 64 to Week 72|T2 hyperintense lesions were measured by MRI brain scans.|Week 64 to Week 72|Participants who received at least 1 dose of BG00012 in this study and had an evaluation of the efficacy endpoint under analysis.|||Participants|||Count of Participants
2568335|NCT02555215|Secondary|Total Number of New or Newly Enlarging T2 Hyperintense Lesions From Week 16 to Week 24|T2 hyperintense lesions were measured by MRI brain scans.|Week 16 to Week 24|Participants who received at least 1 dose of BG00012 in this study and had an evaluation of the efficacy endpoint under analysis.|||Participants|||Count of Participants
2568336|NCT02555215|Primary|Number of Participants Discontinuing Treatment Due to an Adverse Event|An AE is any untoward medical occurrence that does not necessarily have a causal relationship with treatment.|Baseline to Week 96||||participants|||Number
2568337|NCT02555215|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence that does not necessarily have a causal relationship with treatment. An SAE is any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.|Baseline to Week 96|The safety population was defined as all participants who received at least 1 dose of BG00012.|||participants|||Number
2568338|NCT02554981|Secondary|Change From Baseline in the Ocular Discomfort Scale Post Wilkins Test in the Worst Eye|Participants assessed ocular discomfort post Wilkins Rate of Reading Test using the Ora Calibra™ 5-point scale where 0=no discomfort to 4=constant discomfort. A positive number change from Baseline indicates a worsening and a negative number change from Baseline indicates an improvement.|Baseline, Month 6|"Participant from the ITT population, all enrolled participants who received at least one dose of study drug, with data available for analysis. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2568339|NCT02554981|Secondary|Change From Baseline in Reading on the OSDI©|The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Reading question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2568351|NCT02554981|Primary|Change From Baseline in Words Read Incorrectly|The numbers of words read incorrectly are counted. A positive change from Baseline indicates a worsening (more words read incorrectly) and a negative change from Baseline indicates an improvement.|Baseline, Month 6|"ITT population was defined as all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."|||incorrect words||Standard Deviation|Mean
2568340|NCT02554981|Secondary|Change From Baseline in Poor Vision on the OSDI©|The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Poor Vision question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2568341|NCT02554981|Secondary|Change From Baseline in Blurred Vision on the OSDI©|The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Blurred Vision question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2568342|NCT02554981|Secondary|Change From Baseline in Watching Television (TV) on the OSDI©|The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Watching TV question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.|Baseline, Month 6|"Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2568343|NCT02554981|Secondary|Change From Baseline in Working With a Computer or Bank Machine on the OSDI©|The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Working with a Computer or Bank Machine question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.|Baseline, Month 6|"Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2568344|NCT02554981|Secondary|Change From Baseline in Driving at Night on the OSDI©|The OSDI© consists of 12 questions measuring the presence of ocular symptoms. The Driving at Night question was assessed using a 5-point scale (0=none of the time to 4=all of the time). Higher OSDI© scores are associated with greater severity. A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates worsening.|Baseline, Month 6|"Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2568345|NCT02554981|Secondary|Change From Baseline in OSDI© Total Score|The OSDI© questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0 to 100 point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement.|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2568346|NCT02554981|Secondary|Change From Baseline in Interblink Interval (IBI) in the Worst Eye|A device was used to assess IBI. The IBI measures the time in seconds between blinks in the worse eye. A positive number change from baseline indicates a worsening (more frequent blinks) and a negative number change from baseline (less frequent blinks) indicates an improvement.|Baseline, Month 6|"ITT population included all enrolled participants who received at least 1 dose of study drug. n in the category is the number of participants with data available at the given time-point."|||seconds||Standard Deviation|Mean
2568347|NCT02554981|Secondary|Change From Baseline in Ocular Protection Index (OPI) 2.0 in the Worse Eye|A device was used to assess OPI 2.0. This technology measures blink and tear film break-up area. These values demonstrate the average area of tear deficiency/corneal exposure. The worse eye is defined as the worse eye at Baseline. A negative value indicates an improvement in corneal protection.|Baseline, Month 6|"Participants from the ITT population, all enrolled participants who received at least one dose of study drug with data available for analysis. n in the category is the number of participants with data available at the given time-point."|||percent of area||Standard Deviation|Mean
2568348|NCT02554981|Secondary|Change From Baseline in Tear Film Break Up Time (TFBUT) in the Worse Eye|TFBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. The worse eye is defined as the Worse Eye at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a worsening.|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."|||seconds||Standard Deviation|Mean
2568349|NCT02554981|Primary|Change From Baseline in Reading Rate|Reading speed was assessed as the number of words read correctly calculated as words/minute. A positive change from Baseline indicates an improvement (more words read correctly/minute) and a negative change from Baseline indicates a worsening (less words read correctly/minute).|Baseline, Month 6|"ITT population was defined as all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."|||correct words/minute||Standard Deviation|Mean
2568350|NCT02554981|Primary|Change From Baseline in Time to Read Passage|The time to read passage (selected portion of text ) in seconds was assessed. A negative change from Baseline indicates an improvement (less time to read the passage).|Baseline, Month 6|"ITT population was defined as all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."|||seconds||Standard Deviation|Mean
2568352|NCT02554981|Primary|Change From Baseline in Font Size|The minimum font (letter) size read correctly was assessed. Smaller font size (less points) indicates better ability. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening.|Baseline, Month 6|"ITT population was defined as all enrolled participants who received at least one dose of study drug. n in the category is the number of participants with data available at the given time-point."|||points||Standard Deviation|Mean
2568353|NCT02554981|Primary|Change From Baseline in the Central Region Staining Score With Lissamine Green in the Worse Eye|Staining with lissamine green in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2568354|NCT02554981|Primary|Change From Baseline in the Total Conjunctival Staining Score With Lissamine Green in the Worse Eye|Total conjunctival staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2568355|NCT02554981|Primary|Change From Baseline in the Total Corneal Staining Score With Lissamine Green in the Worse Eye|Total corneal staining with lissamine green was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2568356|NCT02554981|Primary|Change From Baseline in the Central Region Staining Score With Fluorescein in the Worse Eye|Staining with fluorescein in the central region of the eye was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2568357|NCT02554981|Primary|Change From Baseline in the Total Conjunctival Staining Score With Fluorescein in the Worse Eye|Total conjunctival staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2568358|NCT02554981|Primary|Change From Baseline in the Total Corneal Staining Score With Fluorescein in the Worse Eye|Total corneal staining with fluorescein was measured in the worse eye using the Ora Calibra™ (Scale 1.0) 5-point scale where 0= none (best), no staining to 4=severe staining (worst). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). The worse eye is defined as the worst eye at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Month 6|"ITT population included all enrolled participants who received at least one dose of the study drug. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2568359|NCT02554929|Secondary|The Preschool Anxiety Scale - Parent Report|The Preschool Anxiety Scale - Parent report (PAS-P) is a 29-item parent-report questionnaire for use with 3- to 6-year-old children. Parents report on their child's anxiety symptoms in different scenarios. Parents rate items on a 5-point Likert scale.|The PAS-P was completed by parents at all 3 time-points: 1) Pre-treatment (baseline), 2) Post-treatment, and 3) 6-month follow-up (from baseline date).||||units on a scale||Standard Deviation|Mean
2568360|NCT02554929|Secondary|Selective Mutism Questionnaire (SMQ)|The Selective Mutism Questionnaire (SMQ) is a 17-item parent questionnaire that assesses the degree and frequency of speech in 3-to-11-year-old children and provides a proxy measure of selective mutism severity. Parents report on their child's behavior with regards to speaking in the previous two weeks across three broad domains (or subscales): at school (five items), at home/with family (five items), and in social situations (seven items). Parents rate items using a three-point scale that ranges from 0 = never to 3 = always. Lower total scores on the Selective Mutism Questionnaire suggest less speech.|The SMQ was completed by parents at all 3 time-points: 1) Pre-treatment (baseline), 2) Post-treatment, and 3) 6-month follow-up (from baseline date).||||units on a scale||Standard Deviation|Mean
2568415|NCT02554786|Secondary|Change Form Baseline in Percentage of Mornings With no Symptoms on Awakening|"All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for mornings with no symptoms on awakening was Did you have asthma symptoms upon awakening in the morning? to be answered with None with scores from 0 (no problem)-4 (very severe problems)."|Up to Week 52|FAS consisted of all participants in the RAN set who received at least one dose of study medication.|||percentage of mornings||Standard Error|Least Squares Mean
2568361|NCT02554929|Secondary|Change in Children's Global Assessment Scale (CGAS)|The Children's Global Assessment Scale (CGAS) is a clinician rating of overall adaptive functioning during the previous month for children and adolescents between 4 to 16 years of age. CGAS scores are rated on a 100-point scale, with 1 being the most impaired and 100 being least impaired, and descriptors for each 10-point interval such that each 10-point interval defines a range of children's functioning in all areas of their life. CGAS scores were secondary outcome measures. The Change in Children's Global Assessment Scale (CGAS) measures level of general functioning on a 100 point scale - 1 (needs constant supervision) to 100 (superior functioning). Every 10 points global functioning moves to the next category.|Change from Baseline on the CGAS at 6 months post-treatment end. Treatment groups run for 11 weeks.||||units on a scale||Standard Error|Mean
2568362|NCT02554929|Secondary|Change in Children's Global Assessment Scale (CGAS)|The Children's Global Assessment Scale (CGAS) is a clinician rating of overall adaptive functioning during the previous month for children and adolescents between 4 to 16 years of age. CGAS scores are rated on a 100-point scale, with 1 being the most impaired and 100 being least impaired, and descriptors for each 10-point interval such that each 10-point interval defines a range of children's functioning in all areas of their life. CGAS scores were secondary outcome measures. The Change in Children's Global Assessment Scale (CGAS) measures level of general functioning on a 100 point scale - 1 (needs constant supervision) to 100 (superior functioning). Every 10 points global functioning moves to the next category.|Change from Baseline on the CGAS within 4 weeks of treatment end. Treatment groups run for 11 weeks.||||units on a scale||Standard Error|Mean
2568363|NCT02554929|Secondary|Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P)|The Anxiety Disorders Interview Schedule for DSM-IV: Parent Version (ADIS-P) is a semi-structured, clinician-administered, interview of parents used to diagnose anxiety and other related disorders in children and adolescents. Parents were asked to rate for interference or impairment using a 9-point scale ranging from 0 to 8, with 0 being not impaired or not interfering and 8 being significant impairment or interference. A final Clinician Severity Rating (CSR) was then established using the same scale, with a CSR of 4 (moderate degree of impairment) or greater required to establish a diagnosis.|Change from Baseline in CSR within 4 weeks of treatment end. Treatment groups run for 11 weeks.||||units on a scale||Standard Error|Mean
2568364|NCT02554929|Primary|Change in Clinical Severity Ratings (CSR) of SAD & SM on the Anxiety Disorders Interview Schedule - Parent Version (ADIS-P)|The Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual of Mental Disorders (DSM-IV): Parent Version (ADIS-P) is a semi-structured, clinician-administered, interview of parents used to diagnose anxiety and other related disorders in children and adolescents. Parents were asked to rate for interference or impairment using a 9-point scale ranging from 0 to 8, with 0 being not impaired or not interfering and 8 being significant impairment or interference. A final Clinician Severity Rating (CSR) was then established using the same scale, with a CSR of 4 (moderate degree of impairment) or greater required to establish a diagnosis.|Change from Baseline in CSR of SAD & SM at 6 months after treatment ends. Treatment groups run for 11 weeks.||||units on a scale||Standard Error|Mean
2568365|NCT02554890|Secondary|N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Values and Change From Baseline at Week 8|"BNP and NT-proBNP are small proteins produced in large amounts when the heart senses it needs to work harder, such as in heart failure. The test measuring BNP to NT-proBNP is measuring how much of each of these biomarkers are present in order to evaluate heart failure.~Plasma NT-proBNP (pg/mL) values were Week 8 visit."|Baseline, Week 8|Full analysis set (FAS): consisted of all randomized patients with the exception for those patients who had not been qualified for randomization and had not received study treatment, but had been inadvertently randomized into the study.|||pg/ml||95% Confidence Interval|Geometric Mean
2568366|NCT02554890|Secondary|Change From Baseline in BNP to NTproBNP Ratio|Time-averaged (Weeks 4 and 8) change from baseline in BNP to NT-proBNP ratio. BNP and NT-proBNP are small proteins produced in large amounts when the heart senses it needs to work harder, such as in heart failure. The test measuring BNP to NT-proBNP is measuring how much of each of these biomarkers are present in order to evaluate heart failure.|baseline, Week 4 and Week 8|FAS|||Ratio||95% Confidence Interval|Geometric Mean
2568367|NCT02554890|Secondary|Change From Baseline in Urinary cGMP to Urinary Creatinine Ratio|"Time-averaged (Weeks 4 and 8) change from baseline in urinary cGMP to urinary creatinine ratio.~Urinary cGMP to urinary creatinine ratio is how much urinary cGMP (which reflects natriuretic peptide activity) compared to a compound in the urine called creatinine (which helps your doctor evaluate how well your kidneys are functioning)."|Baseline, Week 4 and Week 8|FAS|||Ratio||95% Confidence Interval|Geometric Mean
2568368|NCT02554890|Secondary|Change From Baseline in Urinary cGMP|Time-averaged (Weeks 4 and 8) change from baseline in urinary cGMP. Urinary Cyclic GMP (cGMP) is a biomarker measured in the urine that reflects the activity of biomarkers such as BNP (Brain Natriuretic Peptide)|Baseline, Week 4 and Week 8|FAS|||Ratio||95% Confidence Interval|Geometric Mean
2568369|NCT02554890|Secondary|Change From Baseline in High Sensitivity Troponin (Hs-Troponin)|time-averaged (Weeks 4 and 8) change from baseline in hs-troponin T. hs-Troponin-T is a biomarker that is released from the heart under stress or injury conditions.|Baseline, Week 4/Week 8|FAS|||Ratio||95% Confidence Interval|Geometric Mean
2568370|NCT02554890|Secondary|Number of Patients With Incidences of Angioedema|Angioedema is a type of abrupt swelling that occurs under the skin and/or mucous membranes and is often localized to the head, neck, throat, and/or tongue, but may occur elsewhere, including the genitalia and intestines. Severe cases may be associated with difficulty in breathing.|8 weeks of treatment|FAS|||Participants|||Number
2568371|NCT02554890|Secondary|Number of Patients With Incidences of Hyperkalemia|Hyperkalemia is defined as Potassium level >5.5 mEq/L. Hyperkalemia is the medical term that describes a potassium level in your blood that's higher than normal. Potassium is a chemical that is critical to the function of nerve and muscle cells, including those in your heart.|8 weeks of treatment|FAS|||Participants|||Number
2568372|NCT02554890|Secondary|Number of Patients With Incidences of Symptomatic Hypotension|Examine the effect of LCZ696 vs. enalapril on incidence of symptomatic hypotension during 8 weeks of treatment Hypotension is low blood pressure. Patients with hypotension may experience symptoms when their blood pressure drops, compared to the patient's normal values. Symptoms of hypotension can include dizziness, lightheadedness, blurred vision, weakness, fatigue, nausea, palpitations, and headache.|8 weeks of treatment|FAS|||participants|||Number
2568373|NCT02554890|Primary|N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Values and Time-averaged Change From Baseline|"To assess the effect of in-hospital initiation of sacubitril/valsartan vs. enalapril on the time-averaged percentage change of NT-proBNP from baseline in patients who have been stabilized following hospitalization for ADHF and reduced ejection fraction (left ventricular ejection fraction [LVEF] ≤ 40%) between week 4 and 8.~Number of patients with both a baseline value and a value at Week 4 or Week 8. Plasma NT-proBNP (pg/mL) values were averaged from Week 4 and Week 8 visits. N-terminal pro b-type natriuretic peptide (NTproBNP) are peptide (small proteins) that are either hormones or part of the peptide that contained the hormone at one time. They are continually produced in small quantities in the heart and released in larger quantities when the heart senses that it needs to work harder, as in heart failure."|Baseline, Week 4 and Week 8|Full analysis set (FAS): consisted of all randomized patients with the exception for those patients who had not been qualified for randomization and had not received study treatment, but had been inadvertently randomized into the study.|||pg/ml||95% Confidence Interval|Geometric Mean
2568374|NCT02554877|Secondary|Changes From Baseline in Body Weight at Weeks 2, 4, 8, and 12.|The body weight change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2, 4, 8 and 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.|||kg||Standard Deviation|Mean
2568375|NCT02554877|Secondary|Percent Changes From Baseline for Non‑High Density Lipoprotein (HDL) Cholesterol at Weeks 2, 4, 8 and 12|Non-HDL-C percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) on Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2, 4, 8 and 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
2568376|NCT02554877|Secondary|Percent Changes From Baseline for High Density Lipoprotein‑Cholesterol (HDL‑C) at Weeks 2, 4, 8 and 12|High density lipoprotein-cholesterol (HDL-C) percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2, 4, 8 and 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
2568377|NCT02554877|Secondary|Percent Changes From Baseline for Total Cholesterol at Weeks 2, 4, 8 and 12|Total cholesterol percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) on Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2, 4, 8 and 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
2568378|NCT02554877|Secondary|Percent Changes From Baseline for Triglycerides at Weeks 2, 4, 8 and 12|Triglycerides percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days. Triglycerides MMRM was not appropriate as the data were very skewed and not normally distributed, therefore per SAP non-parametric analysis were reported, presenting medians and CIs for medians, instead. If the data had many outliers even after the log transformation the following non parametric analysis was presented instead of the MMRM. An outlier was defined as any data point falling outside of 3.5 x standard deviations the median.|Baseline, Weeks 2, 4, 8 and 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.|||% (percent change)||Full Range|Median
2568379|NCT02554877|Secondary|Percent Changes From Baseline for Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Weeks 2, 4, 8 and 12|Fasting low density lipoprotein-cholesterol (LDL-C) percent change from baseline (defined as the mean of Day 14 and Day 1 pre-dose) at Weeks 2,4,8 and 12. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2, 4, 8 and 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received. n represented the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
2568380|NCT02554877|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Hypoglycemic Adverse Events (HAEs).|An adverse event (AE) was any untoward medical occurrence in a participant administered a study drug; the event need not necessarily have a causal relationship with the treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reasons: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. An HAE was identified by characteristic symptoms or blood glucose levels. Any events occurring following start of treatment (defined as blinded therapy, including single blind placebo administration on Day 14) or increasing in severity were counted as treatment emergent AE.|Baseline up to Day 119|The safety analysis set was used, which defined as all participants who received at least 1 dose of study drug.|||participants|||Number
2568381|NCT02554877|Secondary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria|Vital signs included seated supine systolic and diastolic blood pressure (BP) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from baseline, diastolic <50 mm Hg; 2), pulse rate <40 or greater than (>) 120 beats per minute (bpm).|Baseline up to Day 98|The safety analysis set was used, which defined as all participants who received at least 1 dose of study drug.|||participants|||Number
2568382|NCT02554877|Secondary|Number of Participants With Change From Baseline and Absolute Values in 12-lead Electrocardiograms (ECGs) Meeting Categorical Summarization Criteria|ECG criteria of potential clinical concern were 1), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval): >=140 milliseconds (msec); >=50% increase from baseline; 2), the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=300 msec; >=25 percent (%) increase when baseline >200 msec; or increase >=50% when baseline less than or equal to (<=)200 msec; 3), time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >=500 msec; increase from baseline >=30 - <60, >=60 msec.|Baseline up to Day 98|The safety analysis set was used, which defined as all participants who received at least 1 dose of study drug.|||participants|||Number
2568383|NCT02554877|Secondary|Number of Participants With Laboratory Test Abnormalities|The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis, and some other tests.|Baseline up to 98 days|The safety analysis set was used, which defined as all participants who received at least 1 dose of study drug.|||participants|||Number
2568384|NCT02554877|Secondary|Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) <7% as Well as <6.5% at Week 12.|HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Week 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received.|||% (percentage of participants)||95% Confidence Interval|Number
2568385|NCT02554877|Secondary|Change From Baseline in Fasting Plasma Glucose at Weeks 2, 4, 8, and 12|Fasting plasma glucose response changed from baseline at Weeks 2,4,8 and 12. Baseline was defined as the average of the measurements obtained during Day 14 visit window and Day 1 pre-dose measurement. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2,4,8 and 12|All participants randomized and who had received at least 1 dose of randomized treatment. n represented the available number of participants for analysis at post-baseline days.|||mg/dL||Standard Deviation|Mean
2568386|NCT02554877|Secondary|Change From Baseline in HbA1c (%) at Weeks 2, 4, and 8|HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study. n represented the available number of participants for analysis at post-baseline days.|Baseline, Weeks 2, 4, 8|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received.n represented the available number of participants for analysis at post-baseline days.|||percentage of HbA1c||Standard Deviation|Mean
2568387|NCT02554877|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 as Compared to Placebo|HbA1c was a form of hemoglobin which was measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Baseline was defined as the last pre-dose measurement prior to first double blind dosing for the study.|Baseline, Week 12|All participants randomized and who received at least 1 dose of randomized treatment, participants were assigned to the randomized treatment regardless of what treatment was received.|||percentage of HbA1c||Standard Deviation|Mean
2568388|NCT02554799|Other Pre-specified|Apparent Volume of Distribution|Exploratory: Apparent volume of distribution of one MMV390048 prototype formulation administered with food or milk|Up to 672 hours post-dose|||||||
2568389|NCT02554799|Other Pre-specified|Oral Plasma Clearance|Exploratory: Oral plasma clearance of one MMV390048 prototype formulation administered with food or milk|Up to 672 hours post-dose|||||||
2568390|NCT02554799|Other Pre-specified|Terminal Elimination Rate Constant|Exploratory: terminal elimination rate constant of one MMV390048 prototype formulation administered with food or milk|Up to 672 hours post-dose|||||||
2568391|NCT02554799|Other Pre-specified|Terminal Elimination Half-life|Exploratory: Terminal elimination half-life of one MMV390048 prototype formulation administered with food or milk|Up to 672 hours post-dose|||||||
2568392|NCT02554799|Other Pre-specified|Area Under the Plasma Concentration-time Curve (AUC)|Exploratory: Area under the plasma concentration-time curve from zero to infinity of one MMV390048 prototype formulation administered with food or milk|Up to 672 hours post-dose|||||||
2568393|NCT02554799|Other Pre-specified|Time to Reach Maximum Plasma Concentration (Tmax)|Exploratory: Time to reach maximum plasma concentration of one MMV390048 prototype formulation administered with food or milk|Up to 672 hours post-dose|||||||
2568394|NCT02554799|Primary|Apparent Volume of Distribution (Vz/F)|Apparent volume of distribution (Vz/F) of two MMV390048 prototype formulations administered in the fasted state|Up to 672 hours post-dose||||Litres||Standard Deviation|Mean
2568395|NCT02554799|Primary|Oral Plasma Clearance (CL/F)|Oral plasma clearance (CL/F) of two MMV390048 prototype formulations administered in the fasted state|Up to 672 hours post-dose||||L/hours||Standard Deviation|Mean
2568396|NCT02554799|Primary|Terminal Elimination Rate Constant (Lambda z)|Terminal elimination rate constant (lambda z) of two MMV390048 prototype formulations administered in the fasted state|Up to 672 hours post-dose||||1/hours||Standard Deviation|Mean
2568397|NCT02554799|Primary|Terminal Elimination Half-life (t1/2)|Terminal elimination half-life (t1/2) of two MMV390048 prototype formulations administered in the fasted state|Up to 672 hours post-dose||||hours||Standard Deviation|Mean
2568398|NCT02554799|Primary|AUC: Area Under the Plasma Concentration-time Curve From Zero to Infinity|Area under the plasma concentration-time curve (AUC) of two MMV390048 prototype formulations administered in the fasted state|From Pre-dose to 672 hours post-dose||||h*ng/mL||Standard Deviation|Mean
2568399|NCT02554799|Primary|Tmax: Time to Reach Peak Plasma Concentration|Time to reach maximum plasma concentration (Tmax) of two MMV390048 prototype formulations administered in the fasted state|Up to 672 hours post-dose||||hours||Standard Deviation|Mean
2568400|NCT02554799|Primary|Cmax: Peak Plasma Concentration|Maximum concentration (Cmax) of two MMV390048 prototype formulations administered in the fasted state|Up to 672 hours post-dose||||ng/mL||Standard Deviation|Mean
2568401|NCT02554786|Secondary|Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is any untoward medical occurrence (i.e., any unfavorable and unintended sign including abnormal laboratory findings, symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. An SAE is defined as any adverse event (appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s) or medical conditions(s) which meets any one of the following criteria: is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant, i.e. defined as an event that jeopardizes the participants or may require medical or surgical intervention.|Approximately up to 56 weeks|Safety Set consisted of all participants who received at least one dose of study medication.|||percentage of participants|||Number
2568402|NCT02554786|Secondary|Percentage of Participants With Composite Endpoint of Serious Asthma Outcomes|A composite endpoint of serious asthma outcomes is defined as asthma-related hospitalization, asthma-related intubation, or asthma-related death and was reviewed by the Adjudication Committee.|Up to Week 52|Safety Set consisted of all participants who received at least one dose of study medication.|||percentage of participants|||Number
2568403|NCT02554786|Secondary|Trough FEV1 Measured After 26 Weeks of Treatment|Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.|Week 26|FAS consisted of all participants in the RAN set who received at least one dose of study medication.|||L||Standard Error|Least Squares Mean
2568404|NCT02554786|Secondary|Asthma Quality of Life Questionnaire (AQLQ)|"AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with a recall time of two weeks and each question to be answered on a 7-point scale (1-totally limited/problems all the time, 7-not at all limited/no problems). It consists of 4 domains:~Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items)~Activity limitation = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items)~Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items)~Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items)~Overall Score = Mean of Items 1 to 32 (32 items)"|Up to Week 52 (Day 364)|FAS consisted of all participants in the RAN set who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2568405|NCT02554786|Secondary|Change From Baseline in Percentage of Rescue Medication Free Days|All participants were given salbutamol/albuterol to use as rescue medication throughout the study along with e-Diary to record rescue medication use. Rescue medication free days is defined as any day where the participant did not use any puffs of rescue medication during daytime and night-time.|Up to Weeks 26 and 52|FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents number of participants with data at respective visit.|||percentage of days||Standard Error|Least Squares Mean
2568406|NCT02554786|Secondary|Total Amounts of Systemic Corticosteroids (in Doses) Used to Treat Asthma Exacerbations|The treatment of asthma exacerbations including the initiation of systemic corticosteroids were done according to investigator's or treating physician's medical judgement and in line with national and international recommendations. If systemic corticosteroids were required, a participant could return to the study after successfully completing a taper of approximately 7-10 days.|Up to Week 52|FAS consisted of all participants in the RAN set who received at least one dose of study medication.|||milligrams||Standard Deviation|Mean
2568407|NCT02554786|Secondary|Percentage of Participants Who Permanently Discontinued Study Medication Due to Asthma Exacerbations||Up to Week 52|FAS consisted of all participants in the RAN set who received at least one dose of study medication.|||percentage of participants|||Number
2568408|NCT02554786|Secondary|Time in Days to Permanent Discontinuation of Study Medication Due to Asthma Exacerbations|The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.|Up to Week 52|FAS consisted of all participants in the RAN set who received at least one dose of study medication.|||days||Full Range|Median
2568409|NCT02554786|Secondary|Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category|The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.|Up to Week 52|FAS consisted of all patients in the RAN set who received at least one dose of study medication.|||percentage of participants|||Number
2568410|NCT02554786|Secondary|Duration in Days of Asthma Exacerbations by Exacerbation Category|The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.|Up to Week 52|FAS consisted of all participant in the RAN set who received at least one dose of study medication.|||days||Standard Deviation|Mean
2568411|NCT02554786|Secondary|Annual Rate of Asthma Exacerbations by Exacerbation Category|The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.|Up to Week 52|FAS consisted of all participants in the RAN set who received at least one dose of study medication.|||exacerbations per year||95% Confidence Interval|Mean
2568412|NCT02554786|Secondary|Time to First Hospitalization for Asthma Exacerbation|The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.|Up to Week 52|FAS consisted of all participants in the RAN set who received at least one dose of study medication.|||days||Full Range|Median
2568413|NCT02554786|Secondary|Time to First Asthma Exacerbation by Exacerbation Category|The exacerbation categories were: All (mild, moderate and severe) and combination of moderate or severe and severe.|Up to Week 52|FAS consisted of all participants in the RAN set who received at least one dose of study medication.|||days||Full Range|Median
2568414|NCT02554786|Secondary|Rescue Medication Usage|All participants were given salbutamol/albuterol to use as rescue medication throughout the study along with e-Diary to record rescue medication use. The number of puffs of rescue medication during the past 12 hours is recorded twice (morning/evening) by the participant prior to taking study medication. The mean daily number of puffs of rescue medication use will be calculated for each participant, done separately for morning (night-time), evening (daytime), and daily (night-time plus daytime) rescue medication use|Up to Weeks 26 and 52|FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents number of participants included in the analysis.|||number of puffs||Standard Error|Least Squares Mean
2568416|NCT02554786|Secondary|Change From Baseline in Percentage of Nights With no Night-time Awakenings|"All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. The question asked for nights with no night-time awakenings was How did you sleep last night? had to be answered with I did not wake up because of any breathing problems with scores from 0 (no problem)-4 (very severe problems)."|Up to Week 52|FAS consisted of all participants in the RAN set who received at least one dose of study medication.|||percentage of nights||Standard Error|Least Squares Mean
2568417|NCT02554786|Secondary|Change Form Baseline in Percentage of Days With no Daytime Symptoms|All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. For days with no daytime symptoms, all 5 evening questions must have a score = 0 with respect to shortness of breath, wheeze, cough, chest tightness and impact on usual daily activities due to symptoms, each with scores from 0 (no problems) to 4 (very severe problems).|Up to Week 52|FAS consisted of all participants in the RAN set who received at least one dose of study medication.|||percentage of days||Standard Error|Least Squares Mean
2568418|NCT02554786|Secondary|Change From Baseline in Percentage of Asthma Symptoms Free Days|All participants were provided with an electronic diary (e-Diary) to record clinical symptoms. They were instructed to routinely complete the e-Diary twice daily at the same time each morning and again approximately 12 hours later in the evening. The e-Diary was reviewed at each visit until study completion. Asthma symptoms free days are days with no daytime symptoms, no night-time awakenings and no symptoms on awakening. The daytime asthma symptom score was based on the daily e-diary recordings by participants with respect to shortness of breath, wheeze, cough, chest tightness, and impact on usual daily activities due to symptoms.|Up to Week 52|FAS consisted of all participants in the RAN set who received at least one dose of study medication.|||percentage of days||Standard Error|Least Squares Mean
2568419|NCT02554786|Secondary|Percentage of Participants Achieving the Minimal Important Difference (MID) ACQ ≥ 0.5 at Weeks 26 and 52|Change from baseline in ACQ-7 scores of ≤ 0.5 was defined as minimal clinically important difference and were considered clinically meaningful. The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means > 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means < 50% of predicted FEV1). The total score was calculated as the mean of all questions|Weeks 26 (Day 183) and 52 (Day 364)|FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents number of participants with data at the respective visit.|||percentage of participants|||Number
2568420|NCT02554786|Secondary|Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment|PEF is a person's maximum speed of expiration. All the participants were instructed to record PEF twice daily using a mini Peak Flow Meter device, once in the morning (before taking the morning dose) and once approximately 12 h later in the evening (before taking the evening dose). At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the e-PEF/diary. The best of 3 values were used.|Up to Weeks 26 and 52|Full Analysis Set (FAS) consisted of all patients in the RAN set who received at least one dose of study medication. n represents tthe number of participants with data at respective visit.|||L/min||Standard Error|Least Squares Mean
2568421|NCT02554786|Secondary|Trough Forced Expiratory Flow (FEF)Between 25% and 75% of FVC (FEF25-75)|FEF is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Trough FEF25-75% is defined as average of the two FEF25-75% measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. It was assessed by performing spirometric assessment.|Up to Week 52 (Day 365)|FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective visit.|||Litres/second (L/s)||Standard Error|Least Squares Mean
2568422|NCT02554786|Secondary|Trough Forced Vital Capacity (FVC)|FVC is the total amount of air exhaled during the FEV test. Trough FVC is defined as average of the two FVC measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. It was assessed by performing spirometric assessment.|Up to Week 52 (Day 365)|FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective visit.|||L||Standard Error|Least Squares Mean
2568423|NCT02554786|Secondary|Post Dose FEV1 (5 Minutes-1 Hour)|Post-dose FEV1 measurements were analyzed at 5 minutes, 15 minutes, 30 minutes and 1 hour. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.|Up to Week 52 (Day 364)|FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective time point.|||L||Standard Error|Least Squares Mean
2568424|NCT02554786|Secondary|Pre-dose FEV1 at Weeks 4 and 12|Pre-dose trough FEV1 is defined as average of the two FEV1 measurements taken 45 min and 15 min pre evening dose. It was assessed by performing spirometric assessment. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.|Weeks 4 (Day 30) and 12 (Day 86)|FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective visit.|||L||Standard Deviation|Least Squares Mean
2568425|NCT02554786|Secondary|Trough FEV1 at Week 52|Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.|Week 52|FAS consisted of all participants in the RAN set who received at least one dose of study medication.|||L||Standard Error|Least Squares Mean
2568426|NCT02554786|Secondary|Asthma Control Questionnaire (ACQ-7) at Weeks 4, 12, 26 and 52|The ACQ-7 measured asthma symptom control and consists of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway calibre (FEV1 % predicted). All 7 questions of the ACQ-7 were equally weighted. Items 1-5 were scored along a 7-point response scale, where 0 = totally controlled and 6 = severely uncontrolled. Item 6 is scored between 0 = no rescue medication and 6 = More than 16 puffs/inhalations most days. The 7th item was scored by the investigator based on the FEV1 % predicted from the masterscope at the site (i.e., Score = 0 means > 95% of predicted FEV1, 1 = 90 - 95%, 2 = 80 - 89%, 3 = 70 - 79%, 4 = 60 - 69%, 5 = 50 - 59%, and Score = 6 means < 50% of predicted FEV1). The total score was calculated as the mean of all questions.|Weeks 4, 12, 26 and 52|FAS consisted of all participants in the RAN set who received at least one dose of study medication. n represents the number of participants with data at respective visit|||score on a scale||Standard Error|Least Squares Mean
2568427|NCT02554786|Primary|Trough Forced Expiratory Volume in One Second (Trough FEV1) at Week 26|Trough FEV1 was assessed by performing spirometric assessment. It is defined as average of the two FEV1 measurements taken 23 hr 15 min and 23 hr 45 min post-evening dose. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.|26 weeks|Full Analysis Set (FAS) consisted of all participants in the RAN set who received at least one dose of study medication.|||litre (L)||Standard Error|Least Squares Mean
2568428|NCT02554682|Primary|Parent-teen Communication About Stopping a Friend From Riding With a Driver Who is Under the Influence of Drugs or Alcohol|"Six months after baseline, parents reported on the frequency that they talked about stopping a friend from riding with a driver who is under the influence of drugs or alcohol. Parents selected from one of the following response choices: never talked about (0); talked about once or twice (1); talked about three or four times (2); talked about a lot, about 5 times or more (3)."|6 months post-enrollment|Parent Population|||units on a scale||Standard Deviation|Mean
2568429|NCT02554682|Primary|Parent-teen Communication About Stopping a Friend From Driving Under the Influence of Drugs or Alcohol|"Six months after baseline, parents reported on the frequency that they talked about stopping a friend from driving under the influence of drugs or alcohol. Parents selected from one of the following response choices: never talked about (0); talked about once or twice (1); talked about three or four times (2); talked about a lot, about 5 times or more (3).stopping a friend from riding with a driver who is under the influence of drugs or alcohol"|6 months post-enrollment|Parent Population|||units on a scale||Standard Deviation|Mean
2568430|NCT02554682|Primary|Parent-teen Communication About What to do if the Teen Needs a Safe Ride Home|"Six months after baseline, parents reported on the frequency that they talked about what to do if the teen needs a safe ride home. Parents selected from one of the following response choices: never talked about (0); talked about once or twice (1); talked about three or four times (2); talked about a lot, about 5 times or more (3)."|6 months post-enrollment|Parent Population|||units on a scale||Standard Deviation|Mean
2568431|NCT02554682|Primary|Parent-teen Communication About Driving Under the Influence of Drugs or Alcohol|"Six months after baseline, parents reported on the frequency that they talked about driving under the influence of drugs or alcohol. Parents selected from one of the following response choices: never talked about (0); talked about once or twice (1); talked about three or four times (2); talked about a lot, about 5 times or more (3)."|6 months post-enrollment|Parent Population|||units on a scale||Standard Deviation|Mean
2568432|NCT02554682|Primary|Parent-teen Communication About What to do if Stopped by a Police Officer|"Six months after baseline, parents reported on the frequency that they talked about what to do if stopped by a police officer. Parents selected from one of the following response choices: never talked about (0); talked about once or twice (1); talked about three or four times (2); talked about a lot, about 5 times or more (3)."|6 months post-enrollment|Parent Population|||units on a scale||Standard Deviation|Mean
2568433|NCT02554682|Primary|Parent-teen Communication About What to do in a Crash|"Six months after baseline, parents reported on the frequency that they talked about what to do in a crash. Parents selected from one of the following response choices: never talked about (0); talked about once or twice (1); talked about three or four times (2); talked about a lot, about 5 times or more (3)."|6 months post-enrollment|Parent Population|||units on a scale||Standard Deviation|Mean
2568434|NCT02554682|Primary|Parent-teen Communication About Being a Safe Passenger|"Six months after baseline, parents reported on the frequency that they talked about being a safe passenger. Parents selected from one of the following response choices: never talked about (0); talked about once or twice (1); talked about three or four times (2); talked about a lot, about 5 times or more (3)."|6 months post-enrollment|Parent Population|||units on a scale||Standard Deviation|Mean
2568435|NCT02554682|Primary|Parent-teen Communication About Dangers of Distracted Driving|"Six months after baseline, parents reported on the frequency that they talked about dangers of distracted driving. Parents selected from one of the following response choices: never talked about (0); talked about once or twice (1); talked about three or four times (2); talked about a lot, about 5 times or more (3)."|6 months post-enrollment|Parent Population|||units on a scale||Standard Deviation|Mean
2568436|NCT02554682|Primary|Parent-teen Communication About Wearing a Seatbelt|"Six months after baseline, parents reported on the frequency that they talked about wearing a seatbelt. Parents selected from one of the following response choices: never talked about (0); talked about once or twice (1); talked about three or four times (2); talked about a lot, about 5 times or more (3)."|6 months post-enrollment|Parent Population|||units on a scale||Standard Deviation|Mean
2568437|NCT02554682|Primary|Parent-teen Communication About Pennsylvania's Graduated Driver Licensing Laws|"Six months after baseline, parents reported on the frequency that they talked about about Pennsylvania's GDL laws. Parents selected from one of the following response choices: never talked about (0); talked about once or twice (1); talked about three or four times (2); talked about a lot, about 5 times or more (3)."|6 months post-enrollment|Parent Population|||units on a scale||Standard Deviation|Mean
2568448|NCT02554435|Secondary|Change From Baseline in Self-regulation|Measured by the Rovinak et al scale. Sub-scales include exercise goals and exercise plans. The possible scores on both subscales range between 10 and 50, with higher scores representing more favorable outcomes in exercise goals and planning.|Change in self-regulation from baseline and 12-weeks||||units on a scale||Standard Deviation|Mean
2568449|NCT02554435|Secondary|Resting Pulse||Resting pulse at the end of the 12 week intervention||||bpm||Standard Deviation|Mean
2568438|NCT02554682|Primary|Parent-teen Communication About the Kinds of Risky Driving Situations That Might Come up in His or Her Friend Group|"Six months after baseline, parents reported on the frequency that they talked about the kinds of risky driving situations that might come up in his or her friend group. Parents selected from one of the following response choices: never talked about (0); talked about once or twice (1); talked about three or four times (2); talked about a lot, about 5 times or more (3)."|6 months post-enrollment|Parent Population|||units on a scale||Standard Deviation|Mean
2568439|NCT02554682|Primary|Parent-teen Communication About Reasons the Teen Wants to Drive|"Six months after baseline, parents reported on the frequency that they talked about reasons the teen wants to drive. Parents selected from one of the following response choices: never talked about (0); talked about once or twice (1); talked about three or four times (2); talked about a lot, about 5 times or more (3)."|6 months post-enrollment|Parent Population|||units on a scale||Standard Deviation|Mean
2568440|NCT02554682|Primary|Frequency of Communication About Sex|Frequency of communication about sex was measured with a single item followed by 4-point Likert-type response categories. Parents were asked: Since your teen's last well-child visit how much have you talked with your teen about sex? (Not at all (1), A little bit (2), Quite a bit (3), or A lot (4)). Teens were asked: Since your last well-child visit, how often have you and your (mother/father) talked about sex? (Never (1), Rarely (2), Sometimes (3), or Often (4)).|4-6 months post-enrollment|Arm 1 only. Parents and teens analyzed separately. Arm 2 (teen driving) had different primary outcomes (see outcomes 4-15) and therefore was not included here.|||units on a scale||Standard Deviation|Mean
2568441|NCT02554682|Primary|Frequency of Communication About Alcohol|Frequency of communication about alcohol was measured with a single item followed by 4-point Likert-type response categories. Parents were asked: Since your teen's last well-child visit how much have you talked with your teen about alcohol? (Not at all (1), A little bit (2), Quite a bit (3), or A lot (4)). Teens were asked: Since your last well-child visit, how often have you and your (mother/father) talked about alcohol? (Never (1), Rarely (2), Sometimes (3), or Often (4)).|4-6 months post-enrollment|Arm 1 only. Parents and teens analyzed separately. Arm 2 (teen driving) had different primary outcomes (see outcomes 4-15) and therefore was not included here.|||units on a scale||Standard Deviation|Mean
2568442|NCT02554682|Primary|Quality of Parent-teen Communication (General- All Groups)|Parents completed the 20-item Parent-Adolescent Communication Scale (PACS) (Barnes & Olson, 1985) which is scored such that a higher total score (sum of all items across scales) indicated better parent-adolescent communication. Teens answered the same questions, with only minor changes in wording when necessary. Scores were summed into an index that ranged from 41-96, α parent = 0.84, and 43-96, α teen = 0.87.|4-6 months post-enrollment|Arm 1 only. Parents and teens analyzed separately. Arm 2 (teen driving) had different primary outcomes (see outcomes 4-15) and therefore was not included here.|||units on a scale||Standard Deviation|Mean
2568443|NCT02554656|Secondary|Clinical Response Rate by Diagnostic Name (Name of Infection)|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall clinical effectiveness of VFEND was assessed as effective, not effective, or indeterminate by the physician based on the clinical course at the end of the observation period or at the time of treatment discontinuation. Overall effectiveness of VFEND was determined by the physician based on the clinical course. Participants achieved clinical effectiveness by Diagnosis (Infection) were counted to assess whether it contributes to the clinical effectiveness."|16 weeks at maximum|"The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at the end of the observation period or at the time of treatment discontinuation. The efficacy analysis sets were 74 participants. Participants assessed as indeterminate (n=7) at the final observation were excluded from the calculation."|||Percentage of Participants||95% Confidence Interval|Number
2568444|NCT02554656|Secondary|Overall Clinical Response|"Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall clinical effectiveness of VFEND was assessed as effective, not effective, or indeterminate by the physician based on the clinical course at the end of the observation period or at the time of treatment discontinuation."|16 weeks at maximum|"The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at the end of the observation period or at the time of treatment discontinuation. The efficacy analysis sets were 74 participants. Participants assessed as indeterminate (n=7) at the final observation were excluded from the calculation."|||Parcentage of Participants||95% Confidence Interval|Number
2568445|NCT02554656|Secondary|Incidence of Aadverse Reactions by Diagnosis (Infection)|An ADR was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Relatedness to VFEND was assessed by the physician. Participants with ADRs were counted by diagnosis (infection) to assess whether it was a risk factor for the occurrence of ADRs.|16 weeks at maximum|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once.|||Percentage of Participants||95% Confidence Interval|Number
2568446|NCT02554656|Secondary|Number of Participants With Adverse Drug Reactions Not Expected From the LPD (Unknown Adverse Drug Reaction)|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to VFEND was assessed by the physician.|16 weeks at maximum|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once.|||Participants|||Number
2568447|NCT02554656|Primary|Number of Participants With Adverse Reactions|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to VFEND was assessed by the physician.|16 weeks at maximum|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once.|||Participants|||Number
2568450|NCT02554435|Secondary|Psychological Feelings|Measured by the Psychological Need Satisfaction in Exercise Scale. Sub-scales include perceived competence, perceived autonomy, and perceived relatedness. Each sub-scale had a range from 1 to 5. Higher scores, in each sub-scale, represent a more favorable outcome.|Psychological feelings at the end of the 12 week intervention||||units on a scale||Standard Deviation|Mean
2568451|NCT02554435|Secondary|Physical Function Measured by the Short Physical Performance Battery|"Physical function is operationalized by 3 functional tests, including repeated chair stands (5 consecutive stands), balance (semi-tandem stand, side-by-side stand, tandem stand) and 8 feet walk. The time it took for participants to complete each test was timed in seconds. The faster the repeated chair stand and 8 feet walk tests were performed, the better the function of the individual. Therefore, lower scores represent a better outcome. These tests were not bound by maximums. The higher score for tandem balance, maximum of 10, represents a better outcome. The balance test is comprised of three positions but time is only recorded for one. Participants start with the semi-tandem, then if they are able to hold the position for 10 seconds they continue to tandem balance test. If they are not able to hold the semi-tandem position for 10 seconds, they then complete the side by side test. In this study, all participants proceeded to the tandem test, so outcome is labeled tandem balance."|Physical function at the end of the 12 week intervention||||seconds||Standard Deviation|Mean
2568452|NCT02554435|Secondary|Quality of Life Measured by the SF-36 Questionnaire|Sub-scales include physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, energy/vitality, and pain. All sub-scales have a range of 0 to 100. High scores and scores closer to 100 represent a better outcome for each sub-scale.|Quality of life at the end of the 12 week intervention||||units on a scale||Standard Deviation|Mean
2568453|NCT02554435|Secondary|Exercise Motivation|"Measured by Behavioral Regulation in Exercise Questionnaire-2. Sub-scales include intrinsic, identified, introjected, extrinsic, and amotivation. Each subscale ranges from 0 - 4, with 0 being lowest and 4 being highest level of motivation for the given subscale. The different subscales measure varying forms of autonomous motivation; therefore high scores (maximum of 4) of intrinsic and identified are better. Alternatively, low scores of introjected, extrinsic, and amotivation are better."|Exercise motivation at the end of the 12 week intervention||||units on a scale||Standard Deviation|Mean
2568454|NCT02554435|Secondary|Blood Pressure||Blood pressure at the end of the 12 week intervention||||mmHg||Standard Deviation|Mean
2568455|NCT02554435|Secondary|Waist-to-Hip Ratio|Waist-to-Hip ratio was calculated by divided the waist circumference (in inches) by the hip circumference (in inches).|Waist-to-hip ratio at the end of the 12 week intervention||||ratio||Standard Deviation|Mean
2568456|NCT02554435|Secondary|Body Mass Index (BMI)||BMI at the end of the 12 week intervention||||kg/m^2||Standard Deviation|Mean
2568457|NCT02554435|Secondary|Weight||Weight at the end of the 12 week intervention||||kg||Standard Deviation|Mean
2568458|NCT02554435|Primary|Steps Per Day|Measured by a SenseWear Armband. Average steps per day over a 7 day period|Steps per day at the end of the 12 week intervention||||steps||Standard Deviation|Mean
2568459|NCT02554435|Primary|6-minute Walk Test|distance walked in 6 minutes|Fitness at the end of the 12 week intervention||||feet||Standard Deviation|Mean
2568460|NCT02554435|Primary|Composite Measure for Cardiovascular Risk Measured by the Framingham Non-laboratory Risk Calculator|Factors within the risk calculator include of age in years, systolic blood pressure, gender, and body mass index. These factors are used to create a composite score to estimate the individual's risk for a cardiac event within the next 10 years. The risk score is not bound by maximums and minimums, however a lower number is more favorable. Among women, a composite risk score of 10 equates to a 6% risk of a cardiovascular event, a risk score of 15 equates to a 13% risk, a risk score of 20 equates to a 28.5% risk, and a risk score of 21 or higher equates to >30% risk of a cardiovascular event within the next 10 years. Among men, a composite risk score of 10 equates to a 9% risk, a risk score of 15 equates to a 21.5% risk, and a risk score of 18 or higher equates to >30% risk of a cardiovascular event within the next 10 years.|Cardiovascular risk at the end of the 12 week intervention||||Risk score||Standard Deviation|Mean
2568461|NCT02554435|Primary|Physical Activity Minutes Measured by a SenseWear Armband|Minutes of moderate-vigorous physical activity over a 7 day period|Physical activity minutes at the end of the 12 week intervention||||minutes per day||Standard Deviation|Mean
2568462|NCT02554279|Secondary|Quality of Blastocysts|Assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cell).|5 days after oocyte retrieval|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||percentage of embryos|Embryos reaching blastocyst stage||Number
2568463|NCT02554279|Secondary|Quality of Embryos|Assessed by cleavage stage.|3 days after oocyte retrieval|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||blastomeres|Total number of blastomere|Standard Deviation|Mean
2568464|NCT02554279|Secondary|Quality of Embryos|Assessed by blastomere uniformity, cell size, the degree of fragmentation, and visual signs of multinucleation.|3 days after oocyte retrieval|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||percentage of embryos|Total number of embryos||Number
2568465|NCT02554279|Secondary|Fertilization Rate|Defined as 100 times the ratio of number of fertilized 2 pronuclei oocytes to the number of oocytes retrieved, for each participant.|On day 1 post-insemination|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||percentage of each participant||Standard Deviation|Mean
2568466|NCT02554279|Secondary|Number of Metaphase II Oocytes||At oocyte retrieval visit (approximately 36 hours after hCG administration)|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product. The number of participants analyzed represent the participants with oocytes retrieved.|||metaphase II oocytes||Standard Deviation|Mean
2568549|NCT02552810|Secondary|Percentage of Patients With Plaque Index|Modified Plaque Index (mPI) was evaluated as the amount of plaque at the cervical part of the implant-supported crown, scored by running a probe along the implant-supported crown surface. Measured as Yes or Not.|At 5 years.||||percentage of participants|||Number
2568468|NCT02554279|Secondary|Follicular Development as Assessed by TVUS|Defined as percentage of participants with follicles having a diameter of ≤9 mm, 10-11 mm, 12-14 mm, 15-16 mm, and ≥17 mm.|On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||percentage of participants|||Number
2568469|NCT02554279|Secondary|Follicular Development as Assessed by TVUS|Defined as average follicle size and average size of 3 largest follicles.|On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||mm||Standard Deviation|Mean
2568470|NCT02554279|Secondary|Early Pregnancy Loss|Defined as participants with 2 positive β-hCG tests but no ongoing pregnancy at 10-11 weeks of gestation in the fresh cycle. Percentage of participants with early pregnancy loss is presented.|At 10-11 weeks of gestation in the fresh cycle|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||percentage of participants|||Number
2568471|NCT02554279|Secondary|Clinical Pregnancy Rate|Defined as percentage of participants with transvaginal ultrasound (TVUS) showing at least 1 intrauterine gestational sac with fetal heart beat at 6-7 weeks of gestation.|4-5 weeks after blastocyst transfer in the fresh cycle|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||percentage of participants|||Number
2568472|NCT02554279|Secondary|Positive β-human Chorionic Gonadotropin (hCG) Rate|Defined as the percentage of participants with 2 positive β-hCG tests within 2 days in serum.|First test approximately 10-14 days after blastocyst transfer in the fresh cycle, with a second test approximately 2 days later if first test was positive|The mITT analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||percentage of participants|||Number
2568473|NCT02554279|Primary|Ongoing Pregnancy Rate|Defined as the percentage of participants with the presence of at least 1 intrauterine pregnancy with a detectable fetal heartbeat at 10-11 weeks of gestation.|8-9 weeks after blastocyst transfer in the fresh cycle|The modified intent-to-treat (mITT) analysis set comprised all randomized participants who received at least 1 dose of investigational medicinal product.|||percentage of participants|||Number
2568474|NCT02554019|Secondary|Percent Changes in Systemic Lupus Erythematosus Disease Activity Index 2000|"Percent changes in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline SLEDAI-2K score.~The SLEDAI-2K is a global index that measures SLE disease activity. It includes 24 items for the 9 organs/systems. Scores range from 0 to 105; a score of 6 is considered clinically important. The index measures disease activity within the last 10 days. Higher scores mean worse outcome. Negative percent change means reduced disease activity."|Baseline to week 14 and at week 28|Intension-To-Treat Set included 36 subjects (12 of each Group). At week 14, 1 subject in Placebo Group had no end of Treatment result; at week 28, 1 subject of 50 mg and 2 subjects of Placebo had no results. The efficacy outcome was based on observed cases.|||percentage of change||Standard Deviation|Mean
2568475|NCT02554019|Secondary|Number of Participants With Improvement of Skin|"Number of Participants with 50% improvement in Cutaneous Lupus Erythematosus Disease Area and Sensitivity Index (CLASI) Activity score. The CLASI is an assessment over 13 body regions (scalp, ears, nose - including malar area, rest of the face, V-area neck - frontal, post. neck & shoulders, chest, abdomen, back and buttocks, arms, hands, legs, feet) and consists of 2 scores: total activity score and total damage score. Only the activity score was used in this study.~The minimum score possible on this scale is 0 and the maximum score is 70. The higher scores mean a worse outcome."|At week14 and week 28|Intension-To-Treat Set included 36 subjects (12 of each Group). At week 14, 1 subject in Placebo Group had no end of Treatment result; at week 28, 1 subject of 50 mg and 2 subjects of Placebo had no results. The efficacy outcome was based on observed cases.|||Participants|||Count of Participants
2568476|NCT02554019|Secondary|Number of Participants With Improvements of Joints|Number of Participants with 50% improvement of swollen/tender joints. A total of 66/68 joints was assessed for the swollen/tender joint count. A joint that is normal (no tenderness or swelling), without signs of inflammation will be graded as 0. A joint with tenderness will be graded as 1 for tender joint count and a joint with swelling will be graded as 1 for swollen joint count. Joints suspected or known to have ischemic osteonecrosis are not to be taken into consideration. Higher scores indicate more disease activity.|At week14 and week 28|Intension-To-Treat Set included 36 subjects (12 of each Group). At week 14, 1 subject in Placebo Group had no end of Treatment result; at week 28, 1 subject of 50 mg and 2 subjects of Placebo had no results. The efficacy outcome was based on observed cases.|||Participants|||Count of Participants
2568477|NCT02554019|Primary|Number of Participants With Changes of Safety Parameters|Number of Participants with changes in vital signs, ECGs, Safety laboratory parameters (full blood count including white differential count, clinical chemistry, thyroid hormones, urinalysis, and faecal occult blood test), Development of anti-drug antibodies against BT063 (anti-BT063), Immunological status of potential viral and bacterial infections (HBV, HCV, HIV, tetanus, diphtheria tuberculosis), EBV / CMV Serology, Premature withdrawals.|Baseline through End of Trial Visit (Week 14)||||Participants|||Count of Participants
2568478|NCT02554019|Primary|Number of Participants With Adverse Events|Number of Participants with Adverse Events (Including SAEs and AEs leading to discontinuation) from Baseline through End of Trial Visit (Week 14)|Baseline through End of Trial Visit (Week 14)||||Participants|||Count of Participants
2568479|NCT02553928|Secondary|ADCS - CGIC Score at Week 12|The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) is a semi-structured interview designed to assess clinically relevant changes in patients with Alzheimer's disease. Items in the ADCS-CGIC interview provide general information, and information about cognition, behaviour, social and daily functioning. Responses to ADCS-CGIC interview result in a global clinical judgement of severity (at baseline) and clinically relevant change at subsequent visits. Severity rated at baseline is only used for reference. The severity at baseline is rated on a 7-point Likert-type scale from 1(normal, not ill at all) to 7 (among the most extremely ill patients). The ADCS-CGIC relevant change is rated on a 7-point Likert-type scale from 1 (marked improvement) to 7 (marked worsening).|ADCS - CGIC score at Week 12|Full analysis set - all randomised patients who took at least one dose of investigational medicinal product, and who had a valid baseline assessment and at least one valid post-baseline assessment of the ADCS-CGIC.|||units on a scale||Standard Error|Mean
2568481|NCT02553915|Secondary|Percent Change in High-sensitivity C-reactive Protein (Hs-CRP) in mg/L|To evaluate whether EPA treatment produces decreases in plasma hs-CRP in mg/L. Levels compared at week o (baseline) and week 12 to obtain percent change. Greater percent decrease in the negative direction indicates better outcome.|12 weeks|Study completers with available biomarker data|||percentage of change in plasma levels||Standard Deviation|Mean
2568482|NCT02553915|Secondary|Percent Changes in Levels of Expression of Inflammation-related Genes for Interleukin (IL)-6 and Tumor Necrosis Factor (TNF)-α (in ΔΔCt Units)|To evaluate whether EPA treatment produces decreases in the expression of inflammation pathway-related genes for IL-6 and TNF-α (in ΔΔCt units). Levels compared at week 0 (baseline) and at week 12 to obtain percent change from baseline. Greater decrease (change in negative direction) indicates better outcome.|12 weeks|Completers with available genetic marker data|||percentage of gene expression level||Standard Deviation|Mean
2568483|NCT02553915|Secondary|Percent Change in Plasma Concentrations of Mitogen-stimulated PBMC IL-6 (pg/mL) and Plasma Tumor Necrosis Factor (TNF)-α (pg/mL)|To evaluate whether EPA treatment produces decreases in plasma levels of mitogen-stimulated PBMC IL-6 and TNF-α (both in in pg/mL). Percent change calculated by comparing week 12 to week 0 (baseline). Greater decrease (change in negative direction) indicates better outcome.|12 weeks|Study completers with available biomarker data|||percentage of change in plasma levels||Standard Deviation|Mean
2568484|NCT02553915|Primary|Percent Change in IDS-C Score After 12 Weeks of Treatment|"To evaluate whether EPA treatment produces a decrease in ratings of depression severity, when compared with placebo-treated subjects; and whether the changes in IL-6 or mitogen- stimulated PBMC TNF-α expression will mediate changes observed in ratings of depression.~Inventory of Depressive Symptomatology-30 item-Clinician Rated (IDS-C30) is a depression severity scale, where lower scores indicate less depressive severity and higher scores indicate greater severity. Minimum score is 0 (zero) and maximum score is 84. Change in score over 12 weeks (from week 0 to week12) is calculated as a percent change from baseline. Greater percent change in the negative direction indicates better outcome."|12 weeks|Study completers with available data|||percentage change in score||Standard Deviation|Mean
2568485|NCT02553915|Primary|Mean Change in Depression Severity Score (IDS-C30) After 12 Weeks of Treatment|To evaluate whether EPA treatment produces a decrease in ratings of depression severity after 12 weeks of treatment, when compared with placebo-treated subjects. Comparison is made between pre-treatment and post-12 weeks treatment. Inventory of Depressive Symptomatology-30 item-Clinician Rated (IDS-C30) is a depression severity scale, where lower scores indicate less depressive severity and higher scores indicate greater severity. Minimum score is 0 (zero) and maximum score is 84.|12 weeks|Study completers with available IDS-C30 data|||score on a scale||Standard Deviation|Mean
2568486|NCT02553915|Primary|Percent Change in Plasma Concentration of Inflammatory Biomarkers IL-6 (pg/mL) and PBMC TNF-α (pg/mL)|To evaluate whether a dose-response relationship exists between dose of EPA and decrease either in plasma interleukin-6 (IL-6) levels (pg/mL) or in mitogen-stimulated peripheral blood mononuclear cell (PBMC) Tumor Necrosis Factor-α (TNF-α) expression and secretion (pg/mL), when compared with placebo. Levels of inflammatory biomarkers were assessed at baseline (week 0) and at week 12 for comparison. Percent changes were calculated as relative to baseline values. Greater percent decrease indicates better outcome.|12 weeks|Study completers with available biomarker data|||percentage of change in plasma levels||Standard Deviation|Mean
2568487|NCT02553798|Other Pre-specified|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 44/ET|The Dermatology Life Quality Index DLQI is a ten question questionnaire, used to measure the impact of skin disease on the quality of life of an affected person. The scoring of each question is as follows: Very much (3), A lot (2), A little (1), Not at all (0), Not relevant (0). Is calculated by summing the score of each question resulting in a max of 30 and a min of 0. Higher the score the more Quality of life is impaired.|Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET|Participant|||scores on a scale||Standard Deviation|Mean
2568488|NCT02553798|Other Pre-specified|Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS)|Hyperhidrosis Disease Severity Scale (HDSS) is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects' condition based on how it affects daily activities.|Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET|Participant|||participants|||Number
2568489|NCT02553798|Other Pre-specified|Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4|Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject's axilla with the arm down by the subject's side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min.|Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET|Participant|||mg/5 min||Standard Deviation|Mean
2568490|NCT02553798|Primary|Long-term Safety Assessed Through Adverse Events and Local Skin Reactions|The Total Participants at risk are based on the Safety population, defined as, Participants who were randomized and received at least one confirmed dose of study drug.|Day 1 - Week 44|Participant|||Adverse Events and Local Skin Reactions|||Number
2568491|NCT02553772|Secondary|Change From Baseline in the Schirmer Test|The Schirmer Test measures tears produced by the eye over 5 minutes using a paper strip inserted into the eye. The results indicate the presence of dry eye (Normal = greater than 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. The worse eye defined as the eye with the lowest score at baseline is used to calculate the change at Day 90. A positive number change from baseline indicates an increase in tears (improvement).|Baseline, Day 90|"ITT population included all randomized participants. n is the number of participants in the category with data available at the given time-point."|||mm||Standard Deviation|Mean
2568492|NCT02553772|Secondary|Change From Baseline in Conjunctival Staining Score|Total conjunctival staining with lissamine green was measured in the worse eye using a 6-point scale where 0= none (best), no staining to 5=severe staining (worst). The total score is calculated as the sum of the 6 regions of the conjunctiva, resulting in a minimum possible score of 0 maximum possible score of 30 (severe staining score of 5 in 6 regions). The worse eye is defined as eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Day 90|"ITT population included all randomized participants. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2568493|NCT02553772|Secondary|Change From Baseline in Corneal Staining Score|Total corneal staining with fluorescein was measured in the worse eye using a 6-point scale where 0= none, no staining (best) to 5=severe staining (worst). The total score is calculated as the sum of 5 regions of the cornea, resulting in a possible minimum score of 0 and a maximum possible score of 25 (severe staining score of 5 in all 5 regions). The worse eye is defined as the eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement).|Baseline, Day 90|"ITT population included all randomized participants. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2568494|NCT02553772|Secondary|Change From Baseline in Tear Break-up Time (TBUT)|TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. The worse eye is used for the calculations and is defined as the eye with the shortest average TBUT at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a worsening.|Baseline, Day 90|"ITT population included all randomized participants. n in the category is the number of participants with data available at the given time-point."|||seconds||Standard Deviation|Mean
2568495|NCT02553772|Primary|Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score|The OSDI© consists of 12 questions the patient is asked measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale where 0=none of the time and 4=all of the time. The score is converted to a 0 to 100-point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement.|Baseline, Day 90|Intent-to-treat population included all randomized participants.|||score on a scale||Standard Deviation|Mean
2568496|NCT02553746|Secondary|Number of Participants With Any Complication.|Number of patients who had any complication after the technique|24hours after the end of the technique.||||Participants|||Count of Participants
2568497|NCT02553746|Secondary|Patient Satisfaction.|The patient is asked if he is satisfied with the technique (Definitely not, Not completely, Yes) and if he would choose the same technique in the future (Yes/No).|12hours after the end of the technique.||||Participants|||Count of Participants
2568498|NCT02553746|Secondary|Low Back Pain Intensity.|The patient is asked to evaluate the lumbar pain by the 11scale Numerical Rating Scale (0 no pain, 10 maximum possible pain).|12hours and 24hours after the end of the technique.|Data not collected||||||
2568499|NCT02553746|Secondary|Number of Patients With Low Back Pain.|Number of patients who reported low back pain after the technique.|12hours and 24hours after the end of the technique.||||Participants|||Count of Participants
2568500|NCT02553746|Secondary|Depth of the Epidural Space Measured by the Needle.|The distance between the skin and the ligamentum flavum measured by the markers on the Tuohy needle.|An expected average of 5 minutes after the beginning of the procedure.|||||||
2568501|NCT02553746|Secondary|Depth of the Epidural Space Measured by Ultrasound.|The distance between the skin and the ligamentum flavum measured by the built-in ultrasound caliper.|An expected average of 3 minutes after the beginning of the procedure.|Data not collected||||||
2568502|NCT02553746|Primary|Time Required.|Time passed from the positioning of the patient on the table until the end of the neuraxial anesthesia|An expected average of 15 minutes.||||seconds||Standard Deviation|Mean
2568503|NCT02553746|Primary|Number of Participants With Change of the Intervertebral Space.|Number of patients to whom the operator had to perform the puncture at a different intervertebral place than the initial one.|An expected average of 10 minutes after the technique.||||Participants|||Count of Participants
2568504|NCT02553746|Primary|Repositioning Frequency.|How many times did the operator change the trajectory of the needle.|An expected average of 10 minutes after the technique.||||repositioning attempts||Standard Deviation|Mean
2568505|NCT02553746|Primary|Number of Attempts Required.|How many times did the operator withdraw the needle and repeated the puncture.|An expected average of 10 minutes after the technique..||||number of attempts||Standard Deviation|Mean
2568506|NCT02553746|Primary|Number of Participants With Success of the Technique at the First Attempt|Number of patients with completion of the technique without any withdrawal or reposition of the needle.|An expected average of 10 minutes after the technique.||||Participants|||Count of Participants
2568507|NCT02553746|Primary|Number of Participants With Successful Techniques|For spinal and epidural anesthesia, success of the technique is defined as the installation of sensory block before surgery. For epidural catheter placement success of the technique is defined as the installation of sensory block after the end of surgery.|An expected average of 10 minutes after the technique.||||Participants|||Count of Participants
2568508|NCT02553629|Secondary|Mean Arterial Blood Pressure|"Mean arterial pressure (MAP in mmHg) will be monitored at 10 minute intervals for 2 hours in the post anesthesia care unit.~The data will be averaged per subject and the mean of the mean values are reported."|2 hours postoperative||||millimeters of mercury||Standard Deviation|Mean
2568509|NCT02553629|Secondary|Respiration|"Respiration will be measured by counting the respiratory rate at 10 min interval for 2 hours in the post anesthesia care unit. The breaths per min (unit 1/min) will be logged.~The data were averaged per subject and the mean of the mean data are reported."|2 hours postoperative||||breaths per minute||Standard Deviation|Mean
2568510|NCT02553629|Secondary|Pain|pain will be scored using numeric rating scale (0-10, with 0 = no pain and 10 = most pain imaginable), at 10 minute intervals at the post anesthesia care unit, but only the mean value will be used in the analysis and reported.|postoperative, for up to 2 hours||||units on a scale||Standard Deviation|Mean
2568511|NCT02553629|Secondary|Extubation|The investigators will assess the time from the injection of the reversal agent until the time to removal of the endotracheal tune (extubation).|intraoperative||||minutes||Inter-Quartile Range|Mean
2568512|NCT02553629|Primary|Surgical Rating|"During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating. This will be done at 10 min intervals from the start of surgery until the end of surgery scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The mean difference in ratings between procedures under deep neuromuscular block and those during moderate neuromuscular block will be evaluated.~The rating scale will be averaged for each subject and the mean values will be reported."|intraoperative||||units on a scale||Standard Deviation|Mean
2568513|NCT02553538|Primary|Percentage of Cancer Screening Tests Completed - As Treated|The primary outcome was the average cancer screening test completion rate over the follow-up period for each eligible patient, with all eligible cancers combined in as treated analyses - excluding patients who either left the network or died during follow-up. The cancer screening test completion rate for each subject was calculated daily, then averaged across the 8-month study period. On any given day, the screening test completion rate was calculated as the number of tests completed divided by the number of eligible tests.|8 Months||||percentage of completed screening visits||95% Confidence Interval|Mean
2568514|NCT02553538|Secondary|Percentage of Patients Completing Any Cancer Screening Test (As Treated)|The percentage of patients completing any cancer screening during follow-up among those who were eligible and overdue for at least one cancer screening at baseline in intention to treat analyses, as the percentage of patients completing each type of cancer screening among those who were eligible and overdue at baseline, removing patients who left our primary care network or who died during follow-up from both intervention and control arms, and also removed patients the navigators were not able to contact from the intervention arm.|8 Months||||percentage of patients|||Number
2568515|NCT02553538|Secondary|Percentage of Patients Completing Any Cancer Screening Test (Intention to Treat)|The percentage of patients completing any cancer screening during follow-up among those who were eligible and overdue for at least one cancer screening at baseline in intention to treat analyses, as the percentage of patients completing each type of cancer screening among those who were eligible and overdue at baseline in intention to treat analyses.|8 Months||||percentage of patients|||Number
2568516|NCT02553538|Primary|Percentage of Cancer Screening Tests Completed - Intention to Treat|The primary outcome was the overall cancer screening test completion rate over the follow-up period for each eligible patient, with all eligible cancers combined in intention to treat analyses. For example, a patient who was eligible for a total of 3 screening tests at a given time could have a completion rate of 0% (none of the 3 tests completed) 33%, 67%, or 100% (all 3 tests completed). By assessing each patient's completion rate over the 8-month follow-up period, the average completion rate over time was estimated from the area under the curve. We also calculated the completion rate for each individual cancer as the percentage of time screening was up to date among eligible patients during follow-up.|8 months||||percentage of screening visits completed||95% Confidence Interval|Mean
2568517|NCT02553512|Secondary|Blood Pressure Management After Use of Digital Health Offering|Summary of provider actions following review of final report with patient (dose or medication change, adherence counseling, referral to a hypertension specialist)|4 weeks||||Participants|||Count of Participants
2568518|NCT02553512|Secondary|Change in Systolic and Diastolic Blood Pressure After Use of Digital Health Offering|Decrease in systolic and diastolic blood pressure (measured in mm Hg) after 2 weeks when compared to baseline|2 weeks||||mm Hg||95% Confidence Interval|Mean
2568519|NCT02553512|Secondary|Proportion of Patients Capable of Achieving Blood Pressure Control on Existing Treatment|Percentage of participants|2 weeks||||percentage of participants|||Number
2568520|NCT02553512|Primary|Pattern of Medication-taking (% Scheduling Adherence)|Percent scheduling adherence is determined by the number of ingestion sensors detected within a ± 2-hour time window around the prescribed dosing period, divided by the number of ingestion sensors detected by the wearable sensor during that dosing period, over the 2-week time frame.|2 weeks||||percentage of scheduling adherence||Full Range|Median
2568521|NCT02553512|Primary|Frequency of Medication-taking (% Taking Adherence)|Percent timing adherence is determined by the number of ingestion sensors detected by the wearable monitor, divided by the total number of ingestion sensors prescribed, for the 2 week-time frame.|2 weeks||||percentage of taking adherence||Full Range|Median
2568522|NCT02553499|Secondary|Trough (Minimum) Concentration (Ctrough) of Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) Receptor Target Engagement|GITR protein is internalized upon binding by MK-1248. To evaluate GITR target engagement, a GITR receptor availability assay was developed to assess the availability of surface GITR following administration of MK-1248. GITR is detected on CD4+CD25+ and CD4+CD95+ T-cell sub-populations using flow cytometry and compared to pre-dose baseline. GITR target engagement is calculated as 100% - (%) GITR receptor availability. The Ctrough of percent GITR target engagement on CD4+CD25+ T-cells is presented. Timepoints: Arm 1: Screening; Cycles 1-4 Day 1: Predose MK-1248, At end of MK-1248 infusion (0.5 hours), 2 hours after start of MK-1248 infusion (2 hours); Cycles 1-4 Days 2, 8 & 15. Arm 2: Screening; Cycles 1-4 Day 1: Predose pembrolizumab, At end of MK-1248 infusion (0.5 hours), 2 hours after start of MK-1248 infusion (2 hours): Cycles 1-4 Days 2, 3, 8 & Day 15: Cycles 5-6: Predose. Each cycle was 21 days.|At designated timepoints (Up to ~4.5 months)|The analysis population consisted of all participants who received MK-1248 and had blood samples assessed for GITR receptor target engagement.|||Percent Target Engagement||Geometric Coefficient of Variation|Geometric Mean
2568523|NCT02553499|Secondary|Maximum Concentration (Cmax) of Glucocorticoid-induced Tumor Necrosis Factor Receptor-related Protein (GITR) Receptor Target Engagement|GITR protein is internalized upon binding by MK-1248. To evaluate GITR target engagement, a GITR receptor availability assay was developed to assess the availability of surface GITR following administration of MK-1248. GITR is detected on CD4+CD25+ and CD4+CD95+ T-cell sub-populations using flow cytometry and compared to pre-dose baseline. GITR target engagement is calculated as 100% - (%) GITR receptor availability. The Cmax of percent GITR target engagement on CD4+CD25+ T-cells is presented. Timepoints: Arm 1: Screening; Cycles 1-4 Day 1: Predose MK-1248, At end of MK-1248 infusion (0.5 hours), 2 hours after start of MK-1248 infusion (2 hours); Cycles 1-4 Days 2, 8 & 15. Arm 2: Screening; Cycles 1-4 Day 1: Predose pembrolizumab, At end of MK-1248 infusion (0.5 hours), 2 hours after start of MK-1248 infusion (2 hours): Cycles 1-4 Days 2, 3, 8 & Day 15: Cycles 5-6: Predose. Each cycle was 21 days.|At designated timepoints (Up to ~4.5 months)|The analysis population consisted of all participants who received MK-1248 and had blood samples assessed for GITR receptor target engagement.|||Percent Target Engagement||Geometric Coefficient of Variation|Geometric Mean
2568534|NCT02553317|Other Pre-specified|Number of Days of Plasma Exchange|The number of days of PE during the overall study drug treatment period, including the number of days of PE during the open-label study drug treatment period. Data were analyzed according to the initial treatment allocation (both before and after switch to open-label caplacizumab).|Overall study drug treatment period, a median (min, max) of 36 (2, 82) days.|ITT Population (for the respective study period, i.e., overall treatment period)|||days||Standard Error|Mean
2568524|NCT02553499|Secondary|Area Under the Concentration-Time Curve From 0 to Infinity (AUC0-inf) of MK-1248 in Serum|AUC0-infinity is the area under the serum concentration-time curve from time zero to infinity. It is a measure of the amount of MK-1248 in blood serum from pre-dose to infinite time. Blood samples were obtained at designated timepoints for the analysis of MK-1248 AUC0-inf. No blood samples were collected for the MK-1248 0.6 mg group in Cycle 4, for the MK-1248 10 mg group in Cycle or for the MK-1248 60 mg + Pembrolizumab group in Cycle 4. Timepoints: Cycles 1-4 Day 1: Predose, post MK-1248 infusion end (~0.5 hours), 2 hours post MK-1248 infusion start (~2 hours); Cycles 1-4 Days 2, 3, 5, 8 & 15. Each cycle was 21 days. (Up to ~3 months)|At designated timepoints (Up to ~3 months)|The analysis population consisted of all participants who received MK-1248 and had blood samples assessed for MK-1248 AUC0-inf.|||Days*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2568525|NCT02553499|Secondary|Trough Concentration (Ctrough) of MK-1248 in Serum|Ctrough is the lowest concentration of MK-1248 in blood serum just before the next dose. Blood samples were obtained at designated timepoints for the analysis of MK-1248 Ctrough, except for during Cycle 1. No blood samples were collected for the analysis of Ctrough in Cycle 1. No samples were collected for the MK-1248 0.6 mg group in Cycles 3 or 4, for the MK-1248 10 mg group in Cycles 1-4, or for the MK-1248 60 mg + Pembrolizumab group in Cycle 4. Timepoints: Cycles 1-4 Day 1: Predose, post MK-1248 infusion end (~0.5 hours), 2 hours post MK-1248 infusion start (~2 hours); Cycles 1-4 Days 2, 3, 5, 8 & 15. Each cycle was 21 days. (Up to ~3 months)|At designated timepoints (Up to ~3 months)|The analysis population consisted of all participants who received MK-1248 and had blood samples assessed for MK-1248 Ctrough. Ctrough data were not collected for the MK-1248 10 mg group|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2568526|NCT02553499|Secondary|Maximum Concentration (Cmax) of MK-1248 in Serum|Cmax is the maximum (peak) concentration of MK-1248 observed in blood serum. Blood samples were obtained at designated timepoints for the analysis of MK-1248 Cmax. Timepoints: Cycles 1-4 Day 1: Predose, post MK-1248 infusion end (~0.5 hours), 2 hours post MK-1248 infusion start (~2 hours); Cycles 1-4 Days 2, 3, 5, 8 & 15. Each cycle was 21 days. (Up to ~3 months)|At designated timepoints (Up to ~3 months)|The analysis population consisted of all participants who received MK-1248 and had blood samples assessed for MK-1248 Cmax.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2568527|NCT02553499|Primary|Number of Participants Experiencing a Dose-Limiting Toxicity (DLT)|The occurrence of any of the following toxicities during Cycle 1 (21 days), if possibly, probably or definitely related to study treatment, was considered a DLT: 1. Grade 4 non-hematological toxicity 2. Grade 4 hematological toxicity lasting >7 days, except thrombocytopenia a. Grade 4 thrombocytopenia of any duration b. Grade 3 thrombocytopenia is a DLT if associated with bleeding 3. Any Grade 3 non-hematological toxicity, with the exceptions 4. Any Grade 3 or Grade 4 non-hematological laboratory abnormality, if medical intervention was required, or abnormality led to hospitalization, or abnormality persisted for >1 week 5. Febrile neutropenia Grade 3 or Grade 4 6. Any drug-related AE which caused participant to discontinue study treatment during Cycle 1 7. Grade 5 toxicity 8. Any treatment-related toxicity which caused a >2-week delay in initiation of Cycle 2.|Cycle 1 (Up to 21 days)|The DLT analysis population consisted of all participants who received MK-1248 and were observed for safety for 21 days after the first dose of MK-1248 or experienced a DLT prior to 21 days after the first dose of MK-1248.|||Participants|||Count of Participants
2568528|NCT02553421|Primary|Notification Rate of ivWatch Device|The notification rate is defined as the number of ivWatch device infiltration notifications issued in a certain amount of time, typically reported in units of notifications per day. The notification rate is the number of notifications per day, excluding cases with clinician confirmed infiltrations. This metric is measured using the subjects in the alarming group since the number of notifications could potentially depend on how quickly nurses reset the device.|Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week|The number of participated in the Alarming group that did not have an infiltration diagnosed by a clinician.|||Notifications per day||95% Confidence Interval|Number
2568529|NCT02553421|Primary|Infiltration Sensitivity|The infiltration sensitivity is defined as the percentage of the clinician-confirmed infiltrations that are detected by the ivWatch device before the clinician's diagnosis. This metric is measured and reported separately for non-alarming and alarming groups, since an infiltration notification by the ivWatch device could bias the clinician's diagnosis.|Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week||||percentage of infiltrations detected||95% Confidence Interval|Number
2568530|NCT02553421|Primary|Time Infiltration Detected by Nurse|The difference in time to detection between the clinician and the ivWatch device is measured from the non-alarming group. This measurement reveals how much earlier the infiltration could have been detected by the ivWatch device compared to the clinician assessments. This metric is measured using the patients in the non-alarming group since an infiltration notification by the ivWatch device could bias the clinician's diagnosis.|Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week||||hours||95% Confidence Interval|Mean
2568531|NCT02553317|Other Pre-specified|Number of Days in Hospital|The number of days in hospital during the overall study drug treatment period, including the number of days in hospital during the open-label study drug treatment period. Data were analyzed according to the initial treatment allocation (both before and after switch to open-label caplacizumab).|Overall study drug treatment period, a median (min, max) of 36 (2, 82) days.|ITT Population (for the respective study period, i.e., overall treatment period)|||days||Standard Error|Mean
2568532|NCT02553317|Other Pre-specified|Number of Days in Intensive Care Unit|The number of days in intensive care unit (ICU) during the overall study drug treatment period, including the number of days in ICU during the open-label study drug treatment period. Data were analyzed according to the initial treatment allocation (both before and after switch to open-label caplacizumab).|Overall study drug treatment period, a median (min, max) of 36 (2, 82) days.|ITT Population (for the respective study period, i.e., overall treatment period)|||days||Standard Error|Mean
2568533|NCT02553317|Other Pre-specified|Total Volume of Plasma Exchange|The total volume of PE during the overall study drug treatment period, including the total volume of PE during the open-label study drug treatment period. Data were analyzed according to the initial treatment allocation (both before and after switch to open-label caplacizumab).|Overall study drug treatment period, a median (min, max) of 36 (2, 82) days.|ITT Population (for the respective study period, i.e., overall treatment period)|||liter(s)||Standard Error|Mean
2568535|NCT02553317|Secondary|Time to Normalization of Organ Damage Marker Levels|"Time to first normalization of LDH, cardiac troponin I (cTnI) and serum creatinine was defined as: first time of LDH ≤ ULN and cTnI ≤ ULN and serum creatinine ≤ ULN - time of first i.v. loading dose of study drug after randomization + 1 minute. Subjects in either initial treatment group who switched to open-label caplacizumab before having reached the endpoint were censored at time of switch.~Of note, the key secondary endpoints were hierarchically ordered to allow statistical testing for these endpoints at the same nominal significance level of 5% without adjustment, as long as the tests occurred in the pre-defined sequential order, and given that all null hypotheses tested for endpoints with a higher rank (including the primary endpoint) were rejected. No confirmatory testing was done for this fourth key secondary endpoint, as the statistical test was not significant for the proportion of subjects with refractory disease (i.e., the third key secondary endpoint)."|Overall study period, a median (min, max) of 65 (2, 110) days. For both treatment groups, normalizations occurring during the open-label period were not evaluated in this analysis.|ITT Population (for the respective study period, i.e., overall study period) with biomarker level data available|||days||95% Confidence Interval|Median
2568536|NCT02553317|Secondary|Number and Percentage of Subjects With Refractory Disease|Number and percentage of subjects with refractory TTP, defined as absence of platelet count doubling after 4 days of standard treatment, and lactate dehydrogenase (LDH) > upper limit of normal (ULN) (i.e., third key secondary endpoint).|The study drug treatment period, a median (min, max) of 36 (2, 82) days.|ITT Population (for the respective study period, i.e., overall treatment period)|||Participants|||Count of Participants
2568537|NCT02553317|Secondary|Number and Percentage of Subjects With a Recurrence of TTP in the Overall Study Period|Number and percentage of subjects with a recurrence of TTP during the Overall Study Period (i.e., including follow-up [FU]) (i.e., second key secondary endpoint).|The overall study period (covers both the overall treatment period and the follow-up period), a median (min, max) of 65 (2, 110) days.|ITT Population (for the respective study period, i.e., overall study period)|||Participants|||Count of Participants
2568538|NCT02553317|Secondary|Number and Percentage of Subjects With TTP-Related Death, Recurrence of TTP, or a Major Thromboembolic Event During the Study Drug Treatment Period|Number and percentage of subjects with TTP-related death, a recurrence of TTP, or at least one treatment-emergent major thromboembolic event during the study drug treatment period (i.e., first key secondary endpoint).|The study drug treatment period, a median (min, max) of 36 (2, 82) days. For both treatment groups, only events that occurred prior to a switch to open-label caplacizumab were evaluated for this analysis.|ITT Population (for the respective study period, i.e., overall treatment period)|||Participants|||Count of Participants
2568539|NCT02553317|Primary|Time to Platelet Count Response|Platelet count response was defined as initial platelet count ≥ 150,000/μL with subsequent stop of daily PE within 5 days. It refers to the first time both conditions, platelet count ≥ 150,000/μL and the stop of daily PE within 5 days, were met.|Only data from the DB daily PE period (median = 5 days) up to the cut-off were used. The cut-off point was defined by whichever occured first: 1) 45 days of daily PE after start of study drug, 2) stop of daily PE, 3) stop of study drug (median = 34 days)|Intent-to-treat (ITT) population (for the respective study period, i.e., DB treatment period)|||days||95% Confidence Interval|Median
2568540|NCT02553135|Secondary|Number of Participants Who Experience an Adverse Event|Adverse events during treatment and follow-up period|24 months||||Participants|||Count of Participants
2568541|NCT02553135|Secondary|Changes in Microperimetry From Baseline|Microperimetry assessments. A negative change from baseline indicates disease worsening.|Baseline to 24 months||||Average Threshold dB||Standard Deviation|Mean
2568542|NCT02553135|Secondary|Change in Retinal Macular Autofluorescence From Baseline|Measured in mm^2 by Fundus Autofluorescence and shows changes in the integrity and metabolism of retinal cells. A negative change from baseline indicates a decrease in size of the retained retina (worsening; disease progression).|12 and 24 months||||mm^2||Standard Deviation|Mean
2568543|NCT02553135|Primary|Change in Best Corrected Visual Acuity From Baseline|Patients will have an assessment of visual acuity using the Early Treatment of Diabetic Retinopathy Study (ETDRS) vision charts in both eyes. Low Luminance BCVA was measured by placing a 2.0 log unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard BCVA. If the BCVA in both eyes was similar the Patient determines the worse eye be selected as the study eye. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.|Baseline, 24 Months||||Letters||Standard Deviation|Mean
2568544|NCT02552966|Secondary|NGSSIQ Score|NGSSI questionnaire score|2 weeks|Fifteen subjects completed the post-treatment questionnaire. While 20 subjects (as indicated on the participant flow section) completed the baseline questionnaire, this section reflects the results of the 15 subjects who completed the questionnaire at 2 weeks post UESAD treatment.|||units on a scale||Standard Deviation|Mean
2568545|NCT02552966|Secondary|GerdQ Score|GERDQ score. Scale of 0-12, higher score indicates increased symptom severity.|2 weeks|Fifteen subjects completed the post-treatment GERDQ questionnaire. While 20 subjects completed the questionnaire at baseline, this section contains results from the 15 who completed the questionnaire 2 weeks post UESAD treatment.|||units on a scale||Standard Deviation|Mean
2568546|NCT02552966|Secondary|RSI Score|Respiratory symptom index (RSI) score. Values between 0 and 45. Higher value is associated with increased symptom severity.|2 weeks|15 subjects completed the RSI post-treatment. The subject flow shows 20 subjects completing this questionnaire at baseline, but this section reflects the 15 subjects who completed this questionnaire post-treatment.|||units on a scale||Standard Deviation|Mean
2568547|NCT02552966|Primary|Salivary Pepsin Concentration|Average salivary pepsin concentration|2 weeks|Twelve subjects provided post-treatment salivary samples for pepsin analysis. While the subject flow shows 20 subjects (all of which completed baseline pepsin analysis), only 12 completed post-treatment testing.|||ng/mL||Standard Deviation|Mean
2568548|NCT02552810|Secondary|Percentage of Patients With Bleeding on Probing|Presence of bleeding within 10 seconds after probing. Measured as Yes or Not.|At 5 years.||||percentage of participants|||Number
2568550|NCT02552810|Secondary|Esthetic Parameters Measured as the Changes in Mesial and Distal Papilla Height (PH) and Buccal Peri-implant Mucosa Changes at the Zenith (REC), Expressed in mm.|"A customized millimeter tubular support (stent) was placed temporarily around each dental implant. For each site, mesial and distal soft tissue dimensions (papilla height, PH), and buccal peri-implant mucosa dimension at the zenith (REC) were measured, and reported in millimeters. Two measurements were recorded. The first at definitive crown delivery (baseline), and the second at the 5 years follow-up examination. Changes in PH and REC were reported in millimeters as the difference between values recorded at the 5-year follow-up and the baseline.~The full procedure was published in:~Canullo L, Iurlaro G, Iannello G. Double-blind randomized controlled trial study on post-extraction immediately restored implants using the switching platform concept: soft tissue response. Preliminary report. Clinical Oral Implants Research [Internet]. 2009 Apr;20(4):414-20."|At 5 years.||||mm||Standard Deviation|Mean
2568551|NCT02552810|Secondary|Peri-implant Marginal Bone Level Changes (Express in mm).|At the time of loading with the provisional crown (T0), periapical standardized digital or analogical radiographs were taken in order to control the perfect adaptation of the abutment on the implant and control peri-implant bone level. The customized film holder was made using an hard silicone on the bite of film holders (Rinn XCP; Dentsply Rinn, Elgin, IL, USA) and the parallel technique was used. Radiographs were also taken at 12 (T1), 24 (T2), 48 (T4), and 60 months (T5) after the final restoration delivery, to evaluate marginal bone level changes.|At 5 years.||||mm||Standard Deviation|Mean
2568552|NCT02552810|Secondary|Any Biological or Technical Complications.|Complications: any biological (pain, swelling, suppuration, etc) and/or mechanical complications (fracture of the framework and/or the veneering material, screw loosening, etc) were considered.|During all the follow-up (5 years)||||participants|||Number
2568553|NCT02552810|Primary|Success Rate of the Implants and Prostheses (Participants).|"An implant was considered a failure if it presented any mobility, assessed by tapping or rocking the implant head with the metallic handles of two instruments, and/or any signs of radiolucency, progressive marginal bone loss or infection, and any mechanical complications (e.g. implant fracture) rendering the implant unusable, though still mechanically stable in the bone. This was evaluated on an intraoral radiograph taken with a paralleling technique strictly perpendicular to the implant-bone interface. The implant stability was assessed at initial loading and following 3 years of application, with the prostheses removed.~A prosthesis was considered a failure if it needed to be replaced by an alternative prosthesis."|During all the follow-up (5 years)||||percentage of participants|||Number
2568554|NCT02552368|Secondary|Canadian Occupational Performance Measure (COPM)|The COPM is an evidence-based outcome measure designed to capture a client's self-perception of performance in 5 patient-identified tasks over time. Patients identified 5 functional activities that they wanted to perform more independently or with greater ease. COPM measurements consisted of a semi-structured interview in which patients rated their performance & satisfaction with each activity on an ordinal scale from 1 to 10. A performance score of 1 indicated they are unable to perform identified task, & a score of 10 indicates they are able to complete the functional task as easy as prior to stroke. A satisfaction score of 1 indicated they were not satisfied at all to 10 indicating they are extremely satisfied with how they complete the identified functional task. Patients would rate (5) functional tasks for their performance and satisfaction. Scores were averaged between the scores from the 5 functional activities.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2568555|NCT02552368|Primary|Change in Action Research Arm Test (ARAT) Score|"The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia (Lyle, 1981). It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation (Platz, Pinkowski, Kim, di Bella, & Johnson, 2005).~The ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from:~3) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty~1) Performs test partially 0) Can perform no part of test~The maximum score achievable on this measure is 57 points."|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2568556|NCT02552355|Primary|Glucose Tolerance|Oral glucose tolerance test was used to measure glucose tolerance. These data are reported as the mean at baseline (pre) and the mean at 12 weeks (post).|Baseline and 12 weeks||||mg/dL||Standard Deviation|Mean
2568557|NCT02552355|Secondary|Glucose Profiles From Real-Time Continuous Glucose Monitoring|Data derived from Continuous Glucose Monitoring was used to calculate mean glucose and mean average glucose excursions (MAGE). These data are reported as the percent change at baseline (pre), 6-8 weeks (Mid), and 12 weeks (post) .|Baseline, Weeks 6-8, 12 weeks|Only a subset of subjects were studied.|||percent change of milligrams/deciliter||Standard Error|Mean
2568558|NCT02552355|Secondary|Intracellular Signaling Proteins|Protein content of intracellular signaling proteins that are implicated in mitochondrial biogenesis, mitochondrial function and insulin sensitivity were measured by Western blotting. Densitometry results are reported as a ratio of protein divided by total amount of protein expressed. All proteins of interest are expressed as phosphorylated relative to total. These data are reported as the percent change from baseline compared to 12 weeks.|Baseline and 12 weeks|Proteins were analyzed in a subset of participants due to limited tissue availability.|||percent change of densitometry ratio||Standard Error|Mean
2568559|NCT02552355|Primary|DNA Synthesis|Incorporation of Deuterium Oxide into DNA will be measured before and after the 12 week interventions.|Baseline and 12 weeks|No data was collected.||||||
2568560|NCT02552355|Primary|Peak Aerobic Capacity|Indirect calorimetry was used to measure peak oxygen consumption during a maximal, graded exercise test. These data are reported as the percent change from baseline compared to 12 weeks.|Baseline and 12 weeks||||percent change of Liters/Minute||Standard Error|Mean
2568561|NCT02552355|Primary|Insulin Sensitivity|Oral glucose tolerance test was used to measure whole-body insulin sensitivity. These data are reported as the mean at baseline (pre) and the mean at 12 weeks (post).|Baseline and 12 weeks||||microInternational units/mL||Standard Deviation|Mean
2568562|NCT02552355|Primary|Body Composition|Dual energy x-ray absorptiometry was used to assess fat-free and fat mass. These data are reported as the mean at baseline (pre) and mean at 12 weeks (post).|Baseline and 12 weeks||||Kilograms||Standard Deviation|Mean
2568563|NCT02552355|Primary|Protein Synthesis|Incorporation of deuterium into proteins to calculate cumulative synthesis rates. Protein synthesis was measured in sub cellular fractions of skeletal muscle including mixed, cytoplasmic and mitochondrial enriched fractions. These data are reported as the mean at 12 weeks.|12 weeks|The number analyzed differs from the over all number due to subject withdrawal from study and/or limited muscle sample.|||% of protein synthesis rate per day||Standard Error|Mean
2568564|NCT02552355|Primary|Mitochondrial Function|Oxygen consumption was assessed via high-resolution mitochondrial respirometry in permeabilized skeletal muscle. This outcome was assessed via 2 different protocols; Protocol 1 was a substrate-uncoupler-inhibitor titration (SUIT) and Protocol 2 was an adenosine diphosphate (ADP) titration. These data are reported as the percent change from baseline compared to 12 weeks.|Baseline and 12 weeks|The number analyzed differs from the overall number due to subject withdrawal from study and/or limited muscle sample.|||percent change in pmol/s/mg tissue||Standard Error|Mean
2568565|NCT02552303|Secondary|Number of Subjects Who Dropped Out|"Drop-out rates will be calculated by the number of protocol weeks the subject completed before withdrawing from the study. Drop out rates for subjects taking active v. placebo study medication were compared.~Withdrawal indicates subjects who were either lost-to-follow-up (LTFU), chose to withdraw (self-withdrawn), were withdrawn by the study's PI (withdrawn by the investigator)."|up to 8 weeks of active study||||Participants|||Count of Participants
2568566|NCT02552303|Primary|The Change in Sleep Continuity From Baseline to Follow-up, as Measured by the Insomnia Severity Index (ISI).|"This outcome measure is based on changes in sleep continuity, as assessed by the Insomnia Severity Index (ISI), which is administered once at baseline and once at follow-up. The ISI (Morin, 1993) was used to assess perceived sleep difficulties or current insomnia symptom severity (i.e., past two weeks). The ISI is a 7-item, self-report instrument with good reliability and validity, and positively correlated with clinician-rated insomnia diagnoses (Bastien, Vallières, & Morin, 2001). Total scores on the full 7-item scale range from 0 - 28 with higher values representing greater sleep continuity disturbance or insomnia severity.~The four different treatment groups will be compared for differences."|ISI is measured once at baseline and once at follow-up (8-10 weeks apart)||||units on a scale (ISI)||Standard Deviation|Mean
2568567|NCT02552147|Post-Hoc|Global Aggressive Behavior Improvement|Caregivers asked which treatment week showed the greatest improvement in aggressive or irritable behavior|Baseline and 7 days||||Participants|||Count of Participants
2568568|NCT02552147|Post-Hoc|Aberrant Behavior Checklist - Inappropriate Speech Subscale Change From Baseline|Aberrant Behavior Checklist (ABC) measures symptom subscales for individuals with neurodevelopmental disorders. The ABC-Inappropriate speech subscale measures Inappropriate speech and related symptoms and the subscale score range is 0 (least symptomatic) to 12 (most symptomatic). The ABC is completed by parents/caregivers.|Baseline and 7 days||||units on a scale||Standard Deviation|Mean
2568569|NCT02552147|Post-Hoc|Aberrant Behavior Checklist - Hyperactivity Subscale Change From Baseline|Aberrant Behavior Checklist (ABC) measures symptom subscales for individuals with neurodevelopmental disorders. The ABC-hyperactivity subscale measures hyperactivity and related symptoms and the subscale score range is 0 (least symptomatic) to 48 (most symptomatic). The ABC is completed by parents/caregivers.|Baseline and 7 days||||units on a scale||Standard Deviation|Mean
2568570|NCT02552147|Post-Hoc|Aberrant Behavior Checklist - Stereotypic Behavior Subscale Change From Baseline|Aberrant Behavior Checklist (ABC) measures symptom subscales for individuals with neurodevelopmental disorders. The ABC-stereotypic behavior subscale measures stereotypic behaviors and related symptoms and the subscale score range is 0 (least symptomatic) to 21 (most symptomatic). The ABC is completed by parents/caregivers.|Baseline and 7 days||||units on a scale||Standard Deviation|Mean
2568571|NCT02552147|Post-Hoc|Aberrant Behavior Checklist - Lethargy/Social Withdrawal Subscale Change From Baseline|Aberrant Behavior Checklist (ABC) measures symptom subscales for individuals with neurodevelopmental disorders. The ABC-lethargy/social withdrawal subscale measures lethargy/social withdrawal and related symptoms and the subscale score range is 0 (least symptomatic) to 48 (most symptomatic). The ABC is completed by parents/caregivers.|Baseline and 7 days||||units on a scale||Standard Deviation|Mean
2568572|NCT02552147|Secondary|Nightly Sleep Quality|Caregivers rated nightly sleep quality from 0 (worst) to 10 (best). Average rating for each treatment week is compared.|Day 7||||units on a scale||Standard Deviation|Mean
2568573|NCT02552147|Secondary|Change in State/Trait Anxiety Inventory (STAI) Score|The State-Trait Anxiety Inventory (STAI) is a measure of trait and state anxiety. It ranges from a score of 20 (least affected) to 80 (most affected).|Baseline and day 7|Data were not collected.||||||
2568574|NCT02552147|Secondary|Change in Frustration and Irritability Ratings During Frustration-induction Go-NoGo Task|Subjects will perform a computerized frustration-induction task and complete a rating scale of irritability and frustration levels.|Baseline and one week|Data were not collected.||||||
2568575|NCT02552147|Secondary|Change in Qualitative Description of Irritability and Aggression Symptoms|"Brief qualitative reports of the patient's subjective experience will be recorded by asking In what ways did you find the patch helpful or harmful during the past week, if at all?."|Baseline and 7 days|Data were not collected.||||||
2568576|NCT02552147|Secondary|Change in Social Responsiveness Scale-Adults (SRS-A)|The Social Responsiveness Scale (SRS) - 2 quantifies impairments in social behaviors seen in autism spectrum disorder and related conditions and their severity. The version used in this study is completed by parents/caregivers. The raw score range is 0 (unaffected) to > 134 (extremely affected). The ABC is completed by parents/caregivers.|Baseline and 7 days.|All participants completing all study visits and for which ratings scales were completed in accordance with study protocol.|||units on a scale||Standard Deviation|Mean
2568577|NCT02552147|Primary|Change From Baseline in Aberrant Behavior Checklist Irritability Subscale (ABC-I)|Aberrant Behavior Checklist (ABC) measures symptom subscales for individuals with neurodevelopmental disorders. The ABC-irritability subscale measures irritability and related symptoms and the subscale score range is 0 (least symptomatic) to 45 (most symptomatic). The ABC is completed by parents/caregivers.|Baseline and 7 days.|All participants who completing all study visits and for which ratings scales were completed in accordance with study protocol.|||units on a scale||Standard Deviation|Mean
2568625|NCT02552121|Secondary|Part 1: Number of Participants Who Experienced a Bleeding Event||Baseline to end of trial (Part 1), up to 72 weeks||||Participants|||Count of Participants
2568578|NCT02552121|Secondary|Part 2: Duration of Response|Duration of response was defined as as the number of days from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the date of first progressive disease (PD) or death.|Baseline to end of trial (Part 2), up to 36 weeks|Duration of Response could not be estimated in the Dose Escalation or the Cohort Expansion parts of the trial because patients with a confirmed response were discontinued due to toxicity or other reason different from progressive disease (PD) or death.||||||
2568579|NCT02552121|Secondary|Part 1: Duration of Response|Duration of response was defined as as the number of days from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) to the date of first progressive disease (PD) or death.|Baseline to end of trial (Part 1), up to 72 weeks|Duration of Response could not be estimated in the Dose Escalation or the Cohort Expansion parts of the trial because patients with a confirmed response were discontinued due to toxicity or other reason different from progressive disease (PD) or death.||||||
2568580|NCT02552121|Secondary|Part 2: Progression Free Survival (PFS)|Progression-free survival was defined as the time in weeks from date of first dose until the date of disease progression or death, whichever is earliest.|Baseline to end of trial (Part 2), up to 36 weeks||||weeks||95% Confidence Interval|Median
2568581|NCT02552121|Secondary|Part 1: Progression Free Survival (PFS)|Progression-free survival was defined as the time in weeks from date of first dose until the date of disease progression or death, whichever is earliest.|Baseline to end of follow-up; maximum time of follow-up was 24 weeks||||weeks||95% Confidence Interval|Median
2568582|NCT02552121|Secondary|Part 2: Number of Participants Who Experienced Disease Control|Participants were defined as having disease control at a specific time point if they had an evaluation of complete response (CR) or partial response (PR) at the time point (with a window of +/- 7 days) or had an evaluation of stable disease (SD), PR or CR at any point from the time point minus 7 days or later.|6, 12, 24 and 36 weeks post first infusion (Part 2)||||Participants|||Count of Participants
2568583|NCT02552121|Secondary|Part 1: Number of Participants Who Experienced Disease Control|Participants were defined as having disease control at a specific time point if they had an evaluation of complete response (CR) or partial response (PR) at the time point (with a window of +/- 7 days) or had an evaluation of stable disease (SD), PR or CR at any point from the time point minus 7 days or later.|6, 12, 24 and 36 weeks post first infusion (Part 1)||||Participants|||Count of Participants
2568584|NCT02552121|Secondary|Part 2: Best Overall Response (OR)|"Best OR (by investigators assessment) was the best response recorded from the start of the treatment until disease progression or death. Complete response: the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Based on non-target lesions, complete response was defined as disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis).~Partial response (PR): ≥ 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LDs.~Stable Disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of LDs while in trial. Based on non-target lesions, stable disease was defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits."|Baseline to end of trial (Part 2), up to 36 weeks||||participants|||Number
2568585|NCT02552121|Secondary|Part 1: Best Overall Response (OR)|"Best OR (by investigators assessment) was the best response recorded from the start of the treatment until disease progression or death. Complete response: the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Based on non-target lesions, complete response was defined as disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (< 10 mm short axis).~Partial response (PR): ≥ 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LDs.~Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of LDs while in trial. Based on non-target lesions, stable disease was defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits."|Baseline to end of trial (Part 1), up to 72 weeks||||participants|||Number
2568586|NCT02552121|Secondary|Part 2: Response Evaluation Based on CA125 (Cancer Antigen 125 [Ovarian and Endometrial Cancer]): Percentage of Change From Baseline to End of Study||Baseline to end of trial (Part 2), up to 36 week|CA 125 was only assessed for participants with Ovarian cancer. No participants from Cohort 5 participated in the End of Trial visit.|||percentage of change||Standard Deviation|Mean
2568587|NCT02552121|Secondary|Part 1: Response Evaluation Based on CA125 (Cancer Antigen 125 [Ovarian and Endometrial Cancer]): Percentage of Change From Baseline to End of Study||Baseline to end of follow-up; maximum follow-up was 24 weeks|CA 125 is only assessed for participants with ovarian and endometrial cancer, 1 participant in Cohort 1 and 1 participant in Cohort 2 had the indication of ovarian or endometrial cancer. No participants from Cohort 1 with the indication of ovarian and endometrial Cancer had results at the End of Study visit.|||percentage of change||Standard Deviation|Mean
2568588|NCT02552121|Secondary|Part 1: Response Evaluation Based on PSA (Prostate Specific Antigen [Prostate Cancer]): Percentage Change From Baseline to End of Study||Baseline to end of follow-up; maximum follow-up was 24 weeks|PSA is only assessed for participants with prostate cancer. 2 participants in Part 1 Cohort 1 and 1 participant in Part 1 Cohort 2 had the indication of prostate cancer.|||percentage of change||Standard Deviation|Mean
2568589|NCT02552121|Secondary|Part 2: Anti-tumor Activity Measured by Percentage of Change in Sum of Lesion Measurements||Baseline to end of trial (Part 2), up to 36 weeks||||percentage of change||Standard Deviation|Mean
2568590|NCT02552121|Secondary|Part 1: Number of Patients Who Experienced Anti-tumor Activity Measured by Tumor Shrinkage||Baseline to end of trial (Part 1), up to 72 weeks||||Participants|||Count of Participants
2568591|NCT02552121|Secondary|Part 2: Number of Participants With a Positive Anti-drug Antibody (ADA) Immunogenicity Result||Baseline to end of trial (Part 2), up to 36 weeks||||Participants|||Count of Participants
2568592|NCT02552121|Secondary|Part 1: Number of Participants With a Positive Anti-drug Antibody (ADA) Immunogenicity Result||Baseline to end of follow-up; maximum follow-up was 24 weeks||||Participants|||Count of Participants
2568593|NCT02552121|Secondary|Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for Free Toxin (MMAE)|Data is only available for Part 1, for Part 2 inadequate samples were collected to fully evaluate separate PK parameters after doses 1, 2, and 3.|Before infusion on Day 1, 8 and 15 of Cycle 1|Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2568594|NCT02552121|Secondary|Part 2: Tmax: Time to Reach the Maximum Plasma Concentration for Free Toxin (MMAE)|Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).|Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1|Insufficient samples were collected for cohorts 3-6 to calculate PK parameters. Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the cycle. Includes data for all randomized participants for whom data were available.|||hours||Geometric Coefficient of Variation|Geometric Mean
2568595|NCT02552121|Secondary|Part 1: Tmax: Time to Reach the Maximum Plasma Concentration for Free Toxin (MMAE)||Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1|Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.|||hours||Geometric Coefficient of Variation|Geometric Mean
2568596|NCT02552121|Secondary|Part 2: Cmax: Maximum Observed Plasma Concentration for Free Toxin (MMAE)|Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).|Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1|Insufficient samples were collected for cohorts 3-6 to calculate PK parameters. Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the cycle. Includes data for all randomized participants for whom data were available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2568597|NCT02552121|Secondary|Part 1: Cmax: Maximum Observed Plasma Concentration for Free Toxin (MMAE)||Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1|Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2568598|NCT02552121|Secondary|Part 2: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Free Toxin (MMAE)|Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).|Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1|Insufficient samples were collected for cohorts 3-6 to calculate PK parameters. Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the cycle. Includes data for all randomized participants for whom data were available.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2568599|NCT02552121|Secondary|Part 1: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Free Toxin (MMAE)||Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1|Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2568600|NCT02552121|Secondary|Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for Total HuMax-TF (Conjugated and Non-conjugated)|Data is only available for Part 1, for Part 2, inadequate samples were collected to fully evaluate separate PK parameters after doses 1, 2, and 3.|Before infusion on Day 1, 8 and 15 of Cycle 1|Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Data includes all randomized participants for whom data were available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2568601|NCT02552121|Secondary|Part 1 & Part 2: Apparent Volume of Distribution (Vz) for Total HuMax-TF (Conjugated and Non-conjugated)|Vz could not be estimated for Part 1 or Part 2 participants due to insufficient number of samples taken.|0 to 2 hours post-dose on days 1, 8, 15, +24 hrs 1st infusion, +24 hrs 3rd infusion, +72 hrs 3rd infusion, +168 hrs 3rd infusion (Part 1) and 0 to 2 hours post-dose on day 1, and pre-dose days 8 and 15 (Part 2) of Cycle 1|Vz could not be estimated for Part 1 or Part 2 participants.||||||
2568602|NCT02552121|Secondary|Part 1 and Part 2: Total Clearance (CL) of Total HuMax-TF (Conjugated and Non-conjugated)|CL could not be estimated for Part 1 or Part 2 participants due to insufficient number of samples taken.|0 to 2 hours post-dose on days 1, 8, 15, +24 hrs 1st infusion, +24 hrs 3rd infusion, +72 hrs 3rd infusion, +168 hrs 3rd infusion (Part 1) and 0 to 2 hours post-dose on day 1, and pre-dose days 8 and 15 (Part 2) of Cycle 1|CL could not be estimated for Part 1 or Part 2 participants.||||||
2568603|NCT02552121|Secondary|Part 1: Terminal Phase Elimination Half-life (T1/2) for Total HuMax-TF (Conjugated and Non-conjugated)|Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase, and therefore t1/2 could not be determined.|Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1|Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported.|||hours||Geometric Coefficient of Variation|Geometric Mean
2568604|NCT02552121|Secondary|Part 2: Tmax: Time to Reach the Maximum Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated)|Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).|Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1|Insufficient samples were collected for cohorts 3-6 to calculate PK parameters. Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the cycle. Includes data for all randomized participants for whom data were available.|||hours||Geometric Coefficient of Variation|Geometric Mean
2568605|NCT02552121|Secondary|Part 1: Tmax: Time to Reach the Maximum Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated)||Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1|Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.|||hours||Geometric Coefficient of Variation|Geometric Mean
2568606|NCT02552121|Secondary|Part 2: Cmax: Maximum Observed Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated)|Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).|Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1|Insufficient samples were collected for cohorts 3-6 to calculate PK parameters. Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the cycle. Includes data for all randomized participants for whom data were available.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2568607|NCT02552121|Secondary|Part 1: Cmax: Maximum Observed Plasma Concentration for Total HuMax-TF (Conjugated and Non-conjugated)||Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1|Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2568608|NCT02552121|Secondary|Part 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Total HuMax-TF (Conjugated and Non-conjugated)|Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase.|Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1|Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Includes data for all randomized participants for whom data were available.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2568609|NCT02552121|Secondary|Part 2: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Total HuMax-TF (Conjugated and Non-conjugated)|Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).|Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1|Insufficient samples were collected for cohorts 3-6 to calculate PK parameters. Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the cycle. Includes data for all randomized participants for whom data were available.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2568610|NCT02552121|Secondary|Part 1: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Total HuMax-TF (Conjugated and Non-conjugated)||Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1|Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2568611|NCT02552121|Secondary|Part 1: Apparent Volume of Distribution (Vz) for Tisotumab Vedotin (HuMax-TF-ADC)|Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase, and therefore Vz could not be determined.|Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1|Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Includes data for all randomized participants for whom data were available.|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
2568612|NCT02552121|Secondary|Part 1: Total Clearance (CL) of Tisotumab Vedotin (HuMax-TF-ADC)|Data is only available for Part 1, for Part 2 inadequate pharmacokinetic samples were collected after the third dose to define a terminal phase, and therefore CL could not be determined.|Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1|Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Includes data for all randomized participants for whom data were available.|||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
2568626|NCT02552121|Secondary|Part 2: Number of Participants Who Experienced a Skin Rash||Baseline to end of trial (Part 2), up to 36 weeks||||Participants|||Count of Participants
2568627|NCT02552121|Secondary|Part 1: Number of Participants Who Experienced a Skin Rash||Baseline to end of follow-up; maximum time of follow-up was 24 weeks||||Participants|||Count of Participants
2568613|NCT02552121|Secondary|Part 1: Terminal Phase Elimination Half-life (T1/2) for Tisotumab Vedotin (HuMax-TF-ADC)|Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase, and therefore t1/2 could not be determined.|Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1|Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Includes data for all randomized participants for whom data were available.|||hours||Geometric Coefficient of Variation|Geometric Mean
2568614|NCT02552121|Secondary|Part 1: Trough Concentration (Ctrough) Steady State Plasma Pharmacokinetic for Tisotumab Vedotin (HuMax-TF-ADC)|Data is only available for Part 1, for Part 2 inadequate samples were collected to fully evaluate separate PK parameters after doses 1, 2, and 3.|Before infusion of Day 1, 8 and 15 of Cycle 1|Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2568615|NCT02552121|Secondary|Part 2: Tmax: Time to Reach the Maximum Plasma Concentration for Tisotumab Vedotin (HuMax-TF-ADC)|Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).|Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1|Insufficient samples were collected for cohorts 3-6 to calculate PK parameters. Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the cycle. Includes data for all randomized participants for whom data were available.|||hours||Geometric Coefficient of Variation|Geometric Mean
2568616|NCT02552121|Secondary|Part 1: Tmax: Time to Reach the Maximum Plasma Concentration for Tisotumab Vedotin (HuMax-TF-ADC)||Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1|Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.|||hours||Geometric Coefficient of Variation|Geometric Mean
2568617|NCT02552121|Secondary|Part 2: Cmax: Maximum Observed Plasma Concentration for Tisotumab Vedotin (HuMax-TF-ADC)|Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).|Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1|Insufficient samples were collected for cohorts 3-6 to calculate PK parameters. Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the cycle. Includes data for all randomized participants for whom data were available.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2568618|NCT02552121|Secondary|Part 1: Cmax: Maximum Observed Plasma Concentration for Tisotumab Vedotin (HuMax-TF-ADC)||Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8, and 15, +24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), and +168 hours 3rd infusion (Day 22) of Cycle 1|Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2568619|NCT02552121|Secondary|Part 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Tisotumab Vedotin (HuMax-TF-ADC)|Data is only available for Part 1, for Part 2 inadequate samples were collected after the third dose to define a terminal phase.|Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8 and 15, + 24 hours 1st infusion (Day 2), +24 hours 3rd infusion (Day 16), +72 hours 3rd infusion (Day 18), +168 hours 3rd infusion (Day 22) of Cycle 1|Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Includes data for all randomized participants for whom data were available.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2568620|NCT02552121|Secondary|Part 2: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Tisotumab Vedotin (HuMax-TF-ADC)|Due to severe ocular toxicity, participants switched to receive Tisotumab vedotin at 2.0 mg/kg administered as an intravenous infusion, over a minimum of 30 minutes, once every 3 weeks (1q3wk). Data has only been provided for participants who received the original dosing schedule of 3 times every 4 weeks (3q4wk).|Before infusion, end of infusion (+15 minutes) and +2 hours post infusion on day 1, and before infusion on days 8 and 15 of Cycle 1|Insufficient samples were collected for cohorts 3-6 to calculate PK parameters. Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the cycle. Includes data for all randomized participants for whom data were available.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2568621|NCT02552121|Secondary|Part 1: AUC0-t: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration for Tisotumab Vedotin (HuMax-TF-ADC)||Before infusion, end of infusion (+15 minutes), and +2 hours post infusion on days 1, 8 and 15, + 24 hours 1st infusion (Day 2), + 24 hours 3rd infusion (Day 16), + 72 hours 3rd infusion (Day 18), + 168 hours 3rd infusion (Day 22) of Cycle 1|Insufficient samples were taken in Cycle 2 and beyond to calculate PK parameters, therefore only Cycle 1 is reported. Cycle 1 is an overall value, calculated over the entire cycle.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2568622|NCT02552121|Secondary|Part 2: Number of Participants Who Experienced a Neuropathy Event||Baseline to end of trial (Part 2), up to 36 weeks||||Participants|||Count of Participants
2568623|NCT02552121|Secondary|Part 1: Number of Participants Who Experienced a Neuropathy Event||Baseline to end of follow-up; maximum time of follow-up was 24 weeks||||Participants|||Count of Participants
2568624|NCT02552121|Secondary|Part 2: Number of Participants Who Experienced a Bleeding Event||Baseline to end of trial (Part 2), up to 36 weeks||||Participants|||Count of Participants
2568628|NCT02552121|Secondary|Part 2: Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Markedly abnormal laboratory values are defined as any grade >=3 laboratory abnormality events.|Baseline to end of trial (Part 2), up to 36 weeks||||Participants|||Count of Participants
2568629|NCT02552121|Secondary|Part 1: Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Markedly abnormal laboratory values are defined as any grade >=3 laboratory abnormality events.|Baseline to end of follow-up; maximum time of follow-up was 24 weeks||||Participants|||Count of Participants
2568630|NCT02552121|Primary|Part 2: Number of Participants Reporting One or More Treatment-related Adverse Events|A treatment-related AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; which has a causal relationship with the treatment.|Baseline to end of trial (Part 2), up to 36 weeks||||Participants|||Count of Participants
2568631|NCT02552121|Primary|Part 1: Number of Participants Reporting One or More Treatment-related Adverse Events|A treatment-related AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; which has a causal relationship with the treatment.|Baseline to end of follow-up; maximum time of follow-up was 24 weeks||||Participants|||Count of Participants
2568632|NCT02552121|Primary|Part 2: Number of Participants Reporting One or More Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3 Adverse Events|A CTCAE AE was determined using the CTCAE grading systems based on NCI-CTCAE version 4.03 assessed by the investigator.|Baseline to end of trial (Part 2), up to 36 weeks||||Participants|||Count of Participants
2568633|NCT02552121|Primary|Part 1: Number of Participants Reporting One or More Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3 Adverse Events|A CTCAE AE was determined using the CTCAE grading systems based on NCI-CTCAE version 4.03 assessed by the investigator.|Baseline to end of follow-up; maximum time of follow-up was 24 weeks||||Participants|||Count of Participants
2568634|NCT02552121|Primary|Part 2: Number of Participants Reporting One or More Infusion-related Adverse Events|An infusion-related adverse event (AE) was defined as an AE occurring during infusion where the onset date and time of the event occurred within infusion time (+24 hours), and the event was judged as related to tisotumab vedotin by the investigator.|Day 1, Day 8 & Day 15 (+1 day) until end of trial (Part 2), up to 36 weeks||||Participants|||Count of Participants
2568635|NCT02552121|Primary|Part 1: Number of Participants Reporting One or More Infusion-related Adverse Events|An infusion-related adverse event (AE) was defined as an AE occurring during infusion where the onset date and time of the event occurred within infusion time (+24 hours), and the event was judged as related to tisotumab vedotin by the investigator.|Day 1, Day 8 & Day 15 (+1 day) until end of treatment (Part 1), approximately 48 weeks||||Participants|||Count of Participants
2568636|NCT02552121|Primary|Part 2: Number of Participants Reporting One or More Serious Adverse Events (SAE)|"A SAE is defined as an AE that met one or more of the following criteria/outcomes which were classified as serious:~Required inpatient hospitalization or prolongation of existing hospitalization. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.~Was a congenital anomaly/birth defect. Medically important determined by the investigator. Resulted in death. Was life-threatening."|Baseline to end of trial (Part 2), up to 36 weeks||||Participants|||Count of Participants
2568637|NCT02552121|Primary|Part 1: Number of Participants Who Experienced at Least One or More Serious Adverse Event (SAE)|"A SAE is defined as an AE that met one or more of the following criteria/outcomes which were classified as serious:~Required inpatient hospitalization or prolongation of existing hospitalization. Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.~Was a congenital anomaly/birth defect. Medically important determined by the investigator. Resulted in death. Was life-threatening."|Baseline to end of follow-up; maximum time of follow-up was 24 weeks||||Participants|||Count of Participants
2568638|NCT02552121|Primary|Part 2: Number of Participants Who Experience at Least One Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline to end of trial (Part 2), up to 36 weeks||||Participants|||Count of Participants
2568639|NCT02552121|Primary|Part 1: Number of Participants Who Experience at Least One Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline to end of follow-up; maximum time of follow-up was 24 weeks||||Participants|||Count of Participants
2568640|NCT02551887|Secondary|Second Dose HPV Vaccine Uptake|The rate of second dose of HPV vaccine uptake, is recorded as the number of patients who receive the second dose of HPV vaccine.|Nine Months|Number in the control condition who were eligible for 2 doses of vaccine.|||Participants|||Number
2568641|NCT02551887|Primary|First Dose HPV Vaccine Uptake|The outcome of primary interest, HPV vaccine uptake, is recorded as the number of patients who receive the first dose of HPV vaccine.|Nine Months|Number of patients that received the first dose of HPV vaccine.|||Participants|||Number
2568642|NCT02551874|Secondary|Change From Baseline in the Mean Value of 24-hour Glucose at Week 2|Change from baseline in the mean value of 24-hour glucose readings measured by Continuous Glucose Monitoring with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior to titrated insulin glargine plus metformin with or without SU after 2 weeks of open-label treatment.|Baseline and Week 2|The randomized subject data set consisted of all randomized subjects who received at least 1 dose of study medication.|||mg/deciliter (dL)||95% Confidence Interval|Least Squares Mean
2568654|NCT02551770|Secondary|Change in Bleeding on Probing (BoP)|For the categorical variable BoP, the frequency of bleeding (present or absent) will be counted (absolute and in percent) over all measured sites around the identified study teeth for each treatment group. The results will be compared between the 12-month follow-up and baseline.|Baseline and 12 Month Follow-Up Visit|ITT data set.|||Sites|Sites||Count of Units
2568643|NCT02551874|Secondary|Percentage of Subjects Achieving a Therapeutic Glycemic Response at Week 24|To examine whether the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 10%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.|Baseline and Week 24|The randomized subject data set consisted of all randomized subjects who received at least 1 dose of study medication.|||Adjusted % Participants||95% Confidence Interval|Number
2568644|NCT02551874|Secondary|Percentage of Subjects Achieving a Therapeutic Glycemic Response, Without Hypoglycaemia, at Week 24|To compare the percentage of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, without any reported hypoglycemia, with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.|Baseline and Week 24|The randomized subject data set consisted of all randomized subjects who received at least 1 dose of study medication.|||Adjusted % Participants||95% Confidence Interval|Number
2568645|NCT02551874|Secondary|Percentage of Subjects With Confirmed Hypoglycaemia at Week 24|Hypoglycemia defined as plasma glucose ≤70 mg/dL (3.9 mmol/L)|Baseline and Week 24|The randomized subject data set consisted of all randomized subjects who received at least 1 dose of study medication.|||Adjusted % Participants||95% Confidence Interval|Number
2568646|NCT02551874|Secondary|Mean Change From Baseline in Total Body Weight at Week 24|To compare the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU versus titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment|Baseline and Week 24|The number of participants is the number of subjects in the randomized subject data set with non-missing baseline assessments and at least one post-baseline assessment.|||kg||95% Confidence Interval|Least Squares Mean
2568647|NCT02551874|Primary|Mean Change From Baseline in HbA1c at Week 24|To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU is noninferior (noninferiority margin of 0.3%) to titrated insulin glargine plus metformin with or without SU after 24 weeks of open-label treatment.|Baseline and Week 24|The randomized subjects data set consisted of all randomized subjects who received at least 1 dose of study medication.|||% HbA1c||95% Confidence Interval|Least Squares Mean
2568648|NCT02551822|Secondary|Patient Global Impression of Improvement (PGI-I) Questionnaire Scale Results|"The Patient Global Impression of Improvement (PGI-I) scale is a global index that may be used to rate the response of a condition to a therapy. It is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a 7 point scale, 1 indicating the participant's condition is Very much better (best possible outcome), and 7 being Very much worse (worst possible outcome). The answers to the 7 questions were then averaged to a score."|Three months after change in program from cycling to continuous or vice versa.|2 Participants in group A and 2 participants in group B withdrew from the study prior to completion.|||units on a scale||Standard Deviation|Mean
2568649|NCT02551822|Secondary|Voiding Diary: Urge Incontinence Episodes|Bladder Diaries (BD) are a useful clinical tool and one of the most common outcome measure used in studies of urinary incontinence and other forms of lower urinary tract dysfunction. The patient is asked to prospectively record the frequency, number and volume of voids and incontinence episodes. The National Institutes of Health (NIH) recommends diary duration of at least three days for research studies.|Three months after change in program from cycling to continuous or vice versa.|2 Participants from group A and two participants from group B withdrew from the study prior to completion.|||Number of leaks per day on 3 day diary||Standard Deviation|Mean
2568650|NCT02551822|Primary|Overactive Bladder Questionnaire-Short Form (OABq) Short Form Symptom Bother Scale Result|"The Overactive Bladder Questionnaire (OAB-q) assesses symptom bother & health-related quality of life (HRQL) for overactive bladder. The short form OAB-q SF, provides a quick assessment of symptom bother, consisting of a 6-item symptom bother scale. The questionnaire is on a 6 point scale, 1 indicates symptom is not bothersome (best outcome), 6 indicates symptom bothers the participant a very great deal (worst possible outcome). The majority of the participants were missing the HRQL portion of the questionnaire, so this portion of the questionnaire was not included in the analysis. These are the raw scores ranges for each question prior to being transformed. The possible scores for complete surveys range from 13 (if the participant marked not bothersome for all 6) to 78 (if the participant marked a very great deal for all 6 questions) once transformed. The reported numbers are the transformed scores [(actual raw score-lowest possible score)/possible raw score range] X 100."|Three months after change in program from cycling to continuous or vice versa.|Two participants in group A and two participants in group B withdrew from the study prior to completion.|||units on a scale||Standard Deviation|Mean
2568651|NCT02551809|Primary|Tolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events|Safety endpoints include local tolerability at the injection site, amyloid-related imaging abnormalities, vital signs, physical examination, 12-lead ECG, laboratory tests and other AEs and SAEs.|78 weeks||||Participants|||Count of Participants
2568652|NCT02551770|Secondary|Change in Post-surgical Pain|Post-surgical pain will be measured on a 100 millimeter visual analog scale. The range is 0 (no pain) to 99 (nearly maximum pain). The lower the value, the better the outcome. The subjects will be instructed to mark their level of pain on a line for both the test quadrant and the control quadrant. The average change in pain level will be determined and compared between the two arms.|1-2 days post surgery, 1 week post surgery, and 2 weeks post surgery|ITT dataset.|||mm||Standard Deviation|Mean
2568653|NCT02551770|Secondary|Change in Root Dentin Hypersensitivity|"Presence of root dentin hypersensitivity will be recorded as none (no reaction from the subject), mild (sensible with no pain), moderate (sensible with slight pain), or severe (sensible with pain that persists for a while) after a conventional air blast is applied to the study tooth. Changes in the frequency of categories will be determined and compared between the two treatment arms. An improvement is defined as a decreased reaction (for example, severe to mild), a deterioration is defined as increased reaction (for example, none to moderate), and unchanged is no change to reaction (for example, mild to mild)."|Baseline and 12 Month Follow-Up Visit|ITT data set study teeth. Baseline collected at either visit 1 or visit 2 based on different versions of CIP.|||Study Teeth|Study Teeth||Count of Units
2568655|NCT02551770|Secondary|Change in Full Mouth Plaque Score (FMPS)|FMPS will be calculated based on the number of tooth surfaces with plaque over the total number of tooth surfaces x 100. The value is presented as a percent. The difference in FMPS between 12 months and baseline will be determined.|Baseline and 12 Month Follow-Up Visit|ITT data set.|||Full Mouth Plaque Score|Tooth surfaces||Number
2568656|NCT02551770|Secondary|Change in Pocket Probing Depth (PPD)|PPD will be measured in millimeters on the study teeth in 6 locations. Outcome is mean change of PPD from baseline at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth at baseline. Analysis will compare the mean change of PPD for test and control treatment arms.|Baseline and 12 Month Follow-Up Visit|ITT dataset.|||mm||Standard Deviation|Mean
2568657|NCT02551770|Secondary|Change in Gingival Margin (GM)|GM will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of GM from baseline at surgery to 12-months-post surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of GM for test and control treatment arms.|Baseline and 12 Month Follow-Up Visit|from the ITT dataset. Missing data was not entered.|||mm||Standard Deviation|Mean
2568658|NCT02551770|Primary|Change in Clinical Attachment Levels (CAL)|CAL will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of CAL from baseline measurements at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of CAL for test and control treatment arms.|Baseline and 12 Month Follow-Up Visit|The ITT data set with imputation of missing values (five CAL values were missing at 12 month follow-up and were replaced with values from 9 month follow-up).|||mm||Standard Deviation|Mean
2568659|NCT02551744|Primary|Number of Participants With Ulcer Recurrence|Follow-up endoscopy was performed at the end of the 6th month|six month|Intention to treat|||participants|||Number
2568660|NCT02551731|Secondary|Part B: Time to Relapse as Confirmed by Video-EEG||Up to Week 64|Due to concerns of participant confidentiality this outcome measure was not analyzed. Only 1 participant participated in Part B due to study termination.||||||
2568661|NCT02551731|Secondary|Part B: Percentage of Participants Who Have a Relapse of Spasms Based on Video-EEG||Up to Week 64|Due to concerns of participant confidentiality this outcome measure was not analyzed. Only 1 participant participated in Part B due to study termination.||||||
2568662|NCT02551731|Secondary|Part B: Median Reduction in Seizure-burden Comparing Seizure Diaries Throughout Part B.||Up to Week 64|Due to concerns of participant confidentiality this outcome measure was not analyzed. Only 1 participant participated in Part B due to study termination.||||||
2568663|NCT02551731|Secondary|Part B: Investigator Impression of Efficacy and Tolerability of Study Drug as Measured by the Change in CGI-I Responses at Every Visit Throughout Part B||Up to Week 64|Due to concerns of participant confidentiality this outcome measure was not analyzed. Only 1 participant participated in Part B due to study termination.||||||
2568664|NCT02551731|Secondary|Part B: Parent Impression of Efficacy and Tolerability of Study Drug as Measured by the Change in Clinical Global Impression of Improvement Assessment (CGI-I), Responses at Every Visit Throughout Part B||Up to Week 64|Due to concerns of participant confidentiality this outcome measure was not analyzed. Only 1 participant participated in Part B due to study termination.||||||
2568665|NCT02551731|Secondary|Part A: Time to Complete Responder Relapse|Complete response was defined as complete resolution of spasms and hypsarrythmia (if present at baseline) confirmed by video-EEG at Day 14.|Day 14|Efficacy Analysis Population: included all participants who received study drug for at least 14 days and underwent video EEG on Day 14.|||Days|||Number
2568666|NCT02551731|Secondary|Part A: Percentage of Complete Responders With Relapse|Complete response was defined as complete resolution of spasms and hypsarrythmia (if present at baseline) confirmed by video-EEG at Day 14.|Day 14|Efficacy Analysis Population: included all participants who received study drug for at least 14 days and underwent video EEG on Day 14.|||Percentage of participants|||Number
2568667|NCT02551731|Secondary|Part A: Percentage of Participants With a Partial Response to Treatment|Partial response was defined as a substantive change in background EEG or reduction in spasms on video EEG obtained at Day 14.|Day 14|Efficacy Analysis Population: included all participants who received study drug for at least 14 days and underwent video EEG on Day 14.|||Percentage of participants|||Number
2568668|NCT02551731|Secondary|Part A: Parent Impression of Efficacy and Tolerability of Study Drug|Parent impression of efficacy and tolerability, as measured by Clinical Global Impression-Global Improvement Scale (CGI-I), was summarized by visit and status of response (Complete/Partial and No Response) at Visit 3 (Day 14), Visit 4 (Week 4), Visit 5 (Week 8), Visit 6 (Week 10), and end of study. The CGI-I was also analyzed in a continuous scale, as follows: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, and 7 = Very much worse|Visit 3 (Day 14), Visit 4 (Week 4), Visit 5 (Week 8), Visit 6 (Week 10), and end of study.|Efficacy Analysis Population: included all participants who received study drug for at least 14 days and underwent video EEG on Day 14.|||Units on a scale||Standard Deviation|Mean
2568669|NCT02551731|Secondary|Part A: Median Reduction in Seizure-burden Comparing Video-EEG at Baseline to Repeat Video-EEG at Day 14||Baseline, Day 14|Efficacy Analysis Population: included all participants who received study drug for at least 14 days and underwent video EEG on Day 14.|||Number of spasms||Inter-Quartile Range|Median
2568670|NCT02551731|Secondary|Part A: Percentage of Participants With Absence of Hypsarrhythmia at Day 14||Day 14|Efficacy Analysis Population: included all participants who received study drug for at least 14 days and underwent video EEG on Day 14.|||Percentage of participants|||Number
2568671|NCT02551731|Secondary|Part A: Percentage of Participants With Absence of Infantile Spasms at Day 14||Day 14|Efficacy Analysis Population: included all participants who received study drug for at least 14 days and underwent video EEG on Day 14.|||Percentage of participants|||Number
2568672|NCT02551731|Primary|Part B: Percentage of Participants Experiencing Adverse Events (AEs), Treatment-Emergent AEs (TEAEs), and Serious Adverse Events (SAEs)||Up to Week 64|Safety Analysis Population: included all participants who received at least one dose of study drug.|||Percentage of participants|||Number
2569456|NCT02542072|Secondary|Overall Lens Handling|Handling (ease of insertion and ease of removal) for comfilcon A and samfilcon A lenses. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.|Baseline, 2 weeks, 4 weeks||||units on a scale||Standard Deviation|Mean
2568673|NCT02551731|Primary|Part A: Percentage of Participants Who Are Considered Complete Responders at Day 14|Complete response was defined as complete resolution of spasms and hypsarrythmia (if present at baseline) confirmed by video-electroencephalogram (EEG) at Day 14.|Day 14|Efficacy Analysis Population: included all participants who received study drug for at least 14 days and underwent video EEG on Day 14.|||Percentage of participants|||Number
2568674|NCT02551692|Primary|Change in Smoke Intake During Cue Exposure Task|Measured by number of puffs.|Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)|Subjects who completed the study.|||puffs||Standard Deviation|Mean
2568675|NCT02551692|Primary|Change in Latency to Smoke During Cue Exposure Task|The latency is the interval between smoking one cigarette and wanting, craving, or needing another.|Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)|Subjects who completed the study.|||seconds||Standard Deviation|Mean
2568676|NCT02551692|Primary|Change in Craving Score During Cue Exposure Task|Scores range from 0 (no craving) to 100 (extreme craving).|Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)|Subjects who completed the study.|||score on a scale||Standard Deviation|Mean
2568677|NCT02551653|Primary|Standardized Uptake Values (SUV) of Radiolabeled GSK2256098 Measured by PET Scan|The PET scan was acquired to measure the uptake of radiolabeled GSK2256098 in the heart and lungs, assessed as the mean standardized uptake value (SUV) averaged over the 60 minute period between 30 and 90 minutes. The analysis was performed on Safety Population which comprised of all participants who received a microdose of study treatment.|Day 1|Safety Population|||Grams per milliliter (g/mL)||Standard Deviation|Mean
2568678|NCT02551653|Primary|Volume of Distribution of Radiolabeled GSK2256098 Measured by PET Scan|The PET scan was acquired to measure the uptake of radiolabeled GSK2256098 in the heart and lungs, assessed as the volume of distribution (VT). The analysis was performed on Safety Population which comprised of all participants who received a microdose of study treatment.|Day 1|Safety Population|||Milliliter per cubic centimeter(mL/cm^3)||Standard Deviation|Mean
2568679|NCT02551432|Other Pre-specified|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|find out predictive biomarker for pembrolizumab. Factors potentially associated with pembrolizumab response will b analyzed for providing the rationale for future patient selection.|3 months|||||||
2568680|NCT02551432|Secondary|Safety(Toxicity)|Safety will be assessed for all subjects and documented according to the CTCAE v4.0|3 months|||||||
2568681|NCT02551432|Secondary|Overall Response (OS)|Tumor response will be assessed based on modified RECIST 1.1|from first dose to death due to any cause, whichever came first, assessed up to 24 months||||months||95% Confidence Interval|Median
2568682|NCT02551432|Secondary|Progression-free Survival|Tumor response will be assessed based on modified RECIST 1.1|from first dose to disease progression or death due to any cause, whichever came first, up to 24months||||months||95% Confidence Interval|Median
2568683|NCT02551432|Primary|Objective Response Rate|Tumor response will be assessed based on modified RECIST 1.1|3 months||||Participants|||Count of Participants
2568684|NCT02551224|Secondary|Comfort of the Mouth Pieces for Performing a Tight Seal With the Lips.|To measure in COPD patients naïve to DPIs, the comfort of the mouth pieces when performing a tight seal with the lips using the Breezhaler® and Ellipta® devices.The mean (SD) score on a scale of 1 - 5 (1 = not at all easy, 2= not very easy, 3=somewhat easy, 4=very easy, 5 = extremely easy)|6 hours|full analysis set|||units on a scale||Standard Deviation|Mean
2568685|NCT02551224|Primary|Patient's Preference on the Feedback Mechanisms of Dose Delivery Confirmation Using the Breezhaler® and Ellipta® Devices|"This study will measure patient's perceptions of dose delivery, using a preference questionnaire on use of the Breezhaler® & Ellipta® devices, in COPD patients naïve to DPI devices.The mean (SD) score on a scale of 1- 5 (1 = not at all confident/not at all; 5 = extremely confident/a very great deal) 1a. How confident were you that you received the full dose of medication from your inhaler?~1=Not At All Confident, 2=Not Very Confident, 3=Somewhat Confident, 4=Confident, 5=Extremely Confident~1b. How certain were you that there was no drug remaining in the device?~1=Not At All Certain,2=Not Very Certain, 3=Somewhat Certain,4=Certain, 5=Extremely Certain~1c. To what extent did the device help you to know that you have received all the medication?~1=Not At All, 2=A Little, 3=Somewhat, 4=Very Much, 5=A Very Great Deal"|6 hours|Full analysis set|||units on a scale||Standard Deviation|Mean
2568686|NCT02551055|Secondary|Plasma Concentration of MLN1117-1003||MLN1117 300 mg + Alisertib arms: Cycle 1 Day 3; MLN1117 300 mg + Paclitaxel arms and MLN1117 200 mg + Docetaxel arms: Cycle 1 Day 2; MLN1117 300 mg + TAK-659 arm: Cycle 1 Days 1 and 17|Pharmacokinetic (PK) evaluable population included all participants in Part 1 (dose escalation of the study for whom there were sufficient dosing and MLN1117 concentration-time data was available).|||ng/mL||Standard Deviation|Mean
2568687|NCT02551055|Secondary|Overall Survival (OS) Based on RECIST Criteria V 1.1 Assessment|OS is defined as the time from the date of randomization to the date of death.|From randomization up to end of Part 2, then every 12 weeks until participant death or until 1 year after the last dose of study drug, whichever occurs first (up to 336 days)|Study was terminated before the initiation of Part 2 of the study.||||||
2568688|NCT02551055|Secondary|Time to Disease Progression (TTP) Based on RECIST Criteria V 1.1 Assessment in Part 2|TTP is defined as the time from the date of randomization to the date of first documentation of PD. PD is defined as 20% increase in the sum of the longest diameter of target lesions for measurable neoplastic disease.|Days 25-28 for MLN1117+TAK-659, MLN1117+Alisertib, and MLN1117+Paclitaxel and Days 18-21 for MLN1117+Docetaxel of Cycles 2, 4, 6; every other cycle until study discontinuation due to disease progression, unacceptable toxicity, or death (up to 336 days)|Study was terminated before the initiation of Part 2 of the study.||||||
2568689|NCT02551055|Secondary|Duration of Response (DOR) Based on RECIST Criteria V 1.1 Assessment in Part 2|DOR is defined as the time from the date of first documentation of a response to the date of first documentation of PD according to RECIST version 1.1 criteria. PD is defined as 20% increase in the sum of the longest diameter of target lesions for measurable neoplastic disease.|Days 25-28 for MLN1117+TAK-659, MLN1117+Alisertib, and MLN1117+Paclitaxel and Days 18-21 for MLN1117+Docetaxel of Cycles 2, 4, 6; every other cycle until study discontinuation due to disease progression, unacceptable toxicity, or death (up to 336 days)|Study was terminated before the initiation of Part 2 of the study.||||||
2571689|NCT02513732|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|0 to 1 year|ITT population|||Participants|||Count of Participants
2568690|NCT02551055|Secondary|Percentage of Participants With Disease Control Based on RECIST Criteria V 1.1 Assessment in Part 2|Disease control rate is defined as the percentage of participants with complete response (CR) + Partial response (PR) + stable disease (SD) according to RECIST version 1.1 criteria. CR is defined as disappearance of all target lesions, PR is defined as 30% decrease in the sum of the longest diameter of target lesions and SD is defined as not qualifying for CR, PR, or PD.|Days 25-28 for MLN1117+TAK-659, MLN1117+Alisertib, and MLN1117+Paclitaxel and Days 18-21 for MLN1117+Docetaxel of Cycles 2, 4, 6; every other cycle until study discontinuation due to disease progression, unacceptable toxicity, or death (up to 336 days)|Study was terminated before the initiation of Part 2 of the study.||||||
2568691|NCT02551055|Secondary|Progression-Free Survival (PFS) Based on RECIST Criteria V 1.1 Assessment in Part 2|PFS is defined as the time from the date of randomization to the date of first documentation of Progressive disease (PD) or death due to any cause, whichever occurs first. PD is defined as an increase of >=20% from the nadir (or baseline, if it represents the point at which the sum of target disease was lowest).|Days 25-28 for MLN1117+TAK-659, MLN1117+Alisertib, and MLN1117+Paclitaxel and Days 18-21 for MLN1117+Docetaxel of Cycles 2, 4, 6; every other cycle until study discontinuation due to disease progression, unacceptable toxicity, or death (up to 336 days)|Study was terminated before the initiation of Part 2 of the study.||||||
2568692|NCT02551055|Secondary|Number of Participants With Dose Delays, Dose Reductions, and Dose Interruptions Due To AE in Part 1 and 2|Per dose modification guidelines, participants who have the study drug held because of treatment related or possibly related AEs may resume study drug treatment after resolution of the AE but may either maintain the same dose level or have doses of study drug reduced (dose reduction) by at least 1 dose level and if needed, by 2 dose levels.|From first dose of study drug through 30 days after the last dose of study drug (approximately up to 366 days)|Safety population is defined as all participants who received at least 1 dose of any study drug. Participants are analyzed according to the treatment actually received.|||Participants|||Count of Participants
2568693|NCT02551055|Secondary|Number of Participants With at Least 1 TEAE and Serious TEAE in Part 1 and 2|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; or a medically important event. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|From first dose of study drug through 30 days after the last dose of study drug (approximately up to 366 days)|Safety population is defined as all participants who received at least 1 dose of any study drug. Participants are analyzed according to the treatment actually received.|||participants|||Number
2568694|NCT02551055|Primary|Overall Response Rate in Part 2|Overall response is defined as complete response (CR) plus partial response (PR) according to Response Evaluation Criteria in Solid tumors (RECIST) version 1.1 criteria. According to RECIST: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions.|Days 25-28 for MLN1117+TAK-659, MLN1117+Alisertib, and MLN1117+Paclitaxel and Days 18-21 for MLN1117+Docetaxel of Cycles 2, 4, 6; every other cycle until study discontinuation due to disease progression, unacceptable toxicity, or death (up to 336 days)|Study was terminated before the initiation of Part 2 of the study.||||||
2568695|NCT02551055|Primary|Number of Participants With at Least 1 Dose Modification Due to AE in Part 1|A decision regarding which study drug requires dose modification is dependent upon the toxicity, its onset, and time course. The causal relationship of each AE should will be assessed in relation to MLN1117 and to the combination agent in each cohort so that dose modifications can be made accordingly. Intrapatient dose reductions of MLN1117 are not permitted during Part 1 Cycle 1 unless the participant experiences a DLT attributed to MLN1117. Per dose modification guidelines, participants who have the study drug held because of treatment related or possibly related AEs may resume study drug treatment after resolution of the AE but may either maintain the same dose level or have doses of study drug reduced (dose reduction) by at least 1 dose level and if needed, by 2 dose levels. When a dose reduction of MLN1117 occurs, the MLN1117 dose will be reduced to the next lower dose that has been established as a safe dose during dose escalation (Part 1).|From first dose of study drug through 30 days after the last dose of study drug (approximately up to 366 days)|Safety population is defined as all participants who received at least 1 dose of any study drug. Participants are analyzed according to the treatment actually received.|||participants|||Number
2568696|NCT02551055|Primary|Number of Participants With at Least 1 Treatment-Emergent Serious Adverse Event (SAE) in Part 1|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; or a medically important event. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|From first dose of study drug through 30 days after the last dose of study drug (approximately up to 366 days)|Safety population is defined as all participants who received at least 1 dose of any study drug. Participants are analyzed according to the treatment actually received.|||participants|||Number
2568697|NCT02551055|Primary|Number of Participants With at Least 1 ≥ Grade 3 TEAE in Part 1|"An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. There are 5 grades of the CTCAE; grade refers to severity. Grade 5 is the most severe, grade 1 is the least severe. As per version 4.0 of the CTCAE, Grade 3 = AE with severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4 = AE with life-threatening consequences; urgent intervention indicated and Grade 5 = Death related to AE."|From first dose of study drug through 30 days after the last dose of study drug (approximately up to 366 days)|Safety population is defined as all participants who received at least 1 dose of any study drug. Participants are analyzed according to the treatment actually received.|||participants|||Number
2568698|NCT02551055|Primary|Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE) in Part 1|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|From first dose of study drug through 30 days after the last dose of study drug (approximately up to 366 days)|Safety population is defined as all participants who received at least 1 dose of any study drug. Participants are analyzed according to the treatment actually received.|||participants|||Number
2568699|NCT02551055|Primary|Number of Participants Who Experienced Cycle 1 Dose Limiting Toxicity (DLT) in Part 1|Toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. DLT defined as any of following considered related to any of treatment by investigator: Grade 4 neutropenia (absolute neutrophil count <500 cells/mm^3) for >7 days; ≥ Grade 3 neutropenia with coincident fever or infection; Grade 4 thrombocytopenia for >7 days; Grade 3 thrombocytopenia with clinically significant bleeding; Platelet count <10,000/mm^3 at any time; Delay in initiation of subsequent therapy cycle by >7 days due to treatment-related toxicity; ≥Grade 3 nonhematological toxicity except Grade 3 arthralgia/myalgia, fatigue that lasts <1 month, diarrhea, fasting hyperglycemia lasting ≤14 days, rash lasting ≤7 days and any other Grade 3 nonhematological toxicity that could be safely, reliably controlled to ≤Grade 1 with appropriate treatment; ≥ Grade 2 nonhematologic toxicities that are considered by investigator to be related to study drugs and dose-limiting.|Up to Cycle 1 (28 days for MLN1117+TAK-659, MLN1117+Alisertib, MLN1117+Paclitaxel or 21 days for MLN1117+Docetaxel)|DLT-evaluable population defined as all participants in Part 1 of study who either experience DLT during Cycle 1 or complete treatment with at least 75% of the planned doses of MLN1117 and the combination partner, and have sufficient follow-up data for the investigators and sponsor to determine whether DLT occurred.|||participants|||Number
2568700|NCT02550873|Other Pre-specified|Change From Baseline in FVC Volume||0 to 28 weeks|All treated subjects|||milliliters||90% Confidence Interval|Least Squares Mean
2568701|NCT02550873|Secondary|Mortality Due to Disease Related Events|Number of patients who died over the 28 week study period due to disease-related events (defined as cough, IPF exacerbation, IPF progression and respiratory decline AEs)|0 to 28 weeks|Safety population|||Participants|||Count of Participants
2568702|NCT02550873|Secondary|Mortality Due to Respiratory Deterioration|Tolerability/safety was assessed over the 28-week study period by the incidence of mortality due to respiratory deterioration|0 to 28 weeks|Safety population|||Participants|||Count of Participants
2568703|NCT02550873|Secondary|All Cause Mortality|Tolerability/safety was assessed over the 28-week study period by the incidence of all cause mortality|0 to 28 weeks|Safety population|||Participants|||Count of Participants
2568704|NCT02550873|Secondary|Percentage of Subjects With Infusion Related Reactions|Infusion Related Reactions were defined as events of headache, fever, facial flushing, pruritus, myalgia, nausea, chest tightness, dyspnea, vomiting, erythema, abdominal discomfort, diaphoresis, shivers, hypertension, hypotension, lightheadedness, palpitations, urticaria and somnolence occurring between the start of a study treatment infusion and one hour after completion of the infusion.|0 to 28 weeks|All treated patients|||Participants|||Count of Participants
2568705|NCT02550873|Secondary|Percentage of Subjects Reporting Respiratory Decline SAEs [Safety and Tolerability]|Tolerability/safety was assessed over the 28-week study period by the number of reported serious respiratory decline AEs|0 to 28 weeks|Safety population|||Participants|||Count of Participants
2568706|NCT02550873|Secondary|Percentage of Subjects Reporting Respiratory Decline AEs|"Tolerability/safety was assessed over the 28-week study period by the number of reported respiratory decline AEs, defined as follows:~Unscheduled visits to a healthcare professional for respiratory status deterioration.~Urgent care visits for respiratory status deterioration.~Hospitalization due to a worsening or exacerbation of respiratory symptoms."|0 to 28 weeks|Safety population|||Participants|||Count of Participants
2568707|NCT02550873|Secondary|Percentage of Subjects Reporting Serious Adverse Events (SAEs)|Tolerability/safety was assessed over the 28-week study period by incidence of SAEs|0 to 28 weeks|Safety population|||Participants|||Count of Participants
2568708|NCT02550873|Secondary|Percentage of Subjects Discontinuing Study Drug Due to AEs|Tolerability/safety was assessed over the 28-week study period by the proportion of subjects who discontinued study drug due to AEs|0 to 28 weeks|Safety population|||Participants|||Count of Participants
2568709|NCT02550873|Secondary|Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)|Tolerability/safety was assessed over the 28-week study period by the number of reported TEAEs|0 to 28 weeks|Safety population (All randomized patients who received at least one dose of study treatment)|||Participants|||Count of Participants
2568710|NCT02550873|Secondary|Change From Baseline in % Predicted Diffusion Capacity of Carbon Monoxide (DLCO).|Pulmonary Function Tests to discern the mean change from Baseline to Week 28 in % predicted diffusion capacity of carbon monoxide (DLCO).|0 to 28 weeks||||percentage of predicted DLCO||90% Confidence Interval|Least Squares Mean
2568711|NCT02550873|Secondary|Number of Subjects With Stable Disease, Defined as a Change in FVC of < 100 mL From Baseline to Week 28.||0 to 28 weeks|All treated subjects with FVC data at Baseline and Week 28|||Participants|||Count of Participants
2568712|NCT02550873|Secondary|Number of Subjects With Stable Disease, Defined as a Change in FVC [% Predicted] of < 5% From Baseline to Week 28.||0 to 28 weeks|All treated subjects with data at baseline and week 28|||Participants|||Count of Participants
2568713|NCT02550873|Secondary|Number of Subjects With an Increase in FVC of ≥ 100 mL and ≥ 200 mL From Baseline to Week 28||0 to 28 weeks|All treated patients with FVC data at Baseline and Week 28|||Participants|||Count of Participants
2568714|NCT02550873|Secondary|Number of Subjects With an Increase in FVC [% Predicted] of ≥ 5% and ≥10% From Baseline to Week 28.||0 to 28 weeks||||Participants|||Count of Participants
2568715|NCT02550873|Secondary|Number of Subjects With a Decline in FVC of ≥ 100 mL and ≥ 200 mL From Baseline to Week 28.||0 to 28 weeks|All treated patients with data at baseline and Week 28|||Participants|||Count of Participants
2568716|NCT02550873|Secondary|Number of Subjects With a Decline in FVC [% Predicted] of ≥ 5% and ≥ 10% From Baseline to Week 28.|Pulmonary Function Tests for the Proportion (%) of subjects with a decline in FVC% predicted of ≥ 5% and ≥ 10% from Baseline to Week 28.|0 to 28 weeks|All treated patients with data at baseline and 28 weeks|||Participants|||Count of Participants
2568717|NCT02550873|Secondary|Correlation Between Mean Change From Baseline in FVC [% Predicted] and Mean Change From Baseline in ILA|Correlation between mean change from Baseline in FVC [% predicted] and mean change from Baseline in volume of parenchymal features on HRCT representative of ILA, including ground glass density, reticular changes, and honeycombing by quantitative imaging software.|0 to 28 weeks|All patients from the ATS population who had FVC and HRCT data at both the Baseline and Week 28 time points.|||Correlation coefficient||95% Confidence Interval|Number
2568718|NCT02550873|Secondary|Change From Baseline in % of Normal Lung on HRCT (%)|Mean change from baseline in % of total lung volume of parenchymal features on HRCT representative of normal lung (non-ILA), including normal and mild low attenuation areas, using quantitative imaging software.|0 to 28 weeks|All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points.|||percentage of total lung volume||90% Confidence Interval|Least Squares Mean
2568719|NCT02550873|Secondary|Change From Baseline in Volume of Normal Lung on HRCT|Mean change from baseline in volume of parenchymal features on HRCT representative of normal lung (non-ILA), including normal and mild low attenuation areas, using quantitative imaging software.|0 to 28 weeks|All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points.|||milliliters||90% Confidence Interval|Least Squares Mean
2568720|NCT02550873|Secondary|Change From Baseline in % of Total Lung Volume of ILA on HRCT|Mean change from baseline in % of total lung volume of parenchymal features on HRCT representative of ILA, including ground glass density, reticular changes, and honeycombing, using quantitative imaging software|0 to 28 weeks|All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points.|||percentage of total lung volume||90% Confidence Interval|Least Squares Mean
2568721|NCT02550873|Secondary|Change From Baseline in Volume of Interstitial Lung Abnormalities (ILA) on HRCT|Mean change from baseline in volume of parenchymal features on HRCT representative of ILA, including ground glass density, reticular changes, and honeycombing, using quantitative imaging software|0 to 28 weeks|All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points.|||milliliters||Standard Error|Mean
2568722|NCT02550873|Secondary|Change From Baseline in Total Lung Volume on High-resolution Computed Tomography (HRCT)|Mean change from baseline in total lung volume on HRCT using quantitative imaging software.|0 to 28 weeks|All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points.|||milliliters||90% Confidence Interval|Least Squares Mean
2568723|NCT02550873|Secondary|Change From Baseline in 6-Minute Walk Distance (6MWD)||0 to 28 weeks|All treated patients|||meters||90% Confidence Interval|Least Squares Mean
2568724|NCT02550873|Primary|Change From Baseline in Forced Vital Capacity (FVC) [% Predicted]|Determine the effect size of PRM-151 relative to placebo in change from Baseline to Week 28 in mean FVC% predicted, pooling subjects on a stable dose of pirfenidone or nintedanib with subjects not on other treatment for IPF.|0 to 28 weeks|All treated patients|||Percentage of predicted FVC||90% Confidence Interval|Least Squares Mean
2568725|NCT02550652|Secondary|Change From Baseline of Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Score|Each VAS had a range from 0-100 with higher scores indicating greater symptom impact on global health status.|Baseline (Day 1), Weeks 4, 12, 24, 36, 52/early termination|Modified intent-to-treat population will include all randomized participants who have received any amount of study drug. Participants who received an incorrect therapy were reported under the treatment arm to which they were randomized.|||score on scale||Standard Deviation|Mean
2568726|NCT02550652|Secondary|Terminal Plasma Half-Life (t1/2) of Obinutuzumab||Day 0, Week 24, Week 52|Pharmacokinetic population included all patients randomized to and received any dose of obinutuzumab given as study medication.|||day||Standard Deviation|Mean
2568727|NCT02550652|Secondary|Volume of Distribution Under Steady State (Vss) of Obinutuzumab||Day 0, Week 24, Week 52|Pharmacokinetic population included all patients randomized to and received any dose of obinutuzumab given as study medication.|||L||Standard Deviation|Mean
2568728|NCT02550652|Secondary|Systemic Clearance of Obinutuzumab||Day 0, Week 24, Week 52|Pharmacokinetic population included all patients randomized to and received any dose of obinutuzumab given as study medication.|||L/day||Standard Deviation|Mean
2568729|NCT02550652|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of Obinutuzumab||Week 0, Week 24, Week 52|Pharmacokinetic population included all patients randomized to and received any dose of obinutuzumab given as study medication.|||ug/mL*day||Standard Deviation|Mean
2568730|NCT02550652|Secondary|Maximum Observed Plasma Concentration (Cmax) of Obinutuzumab||Week 0, Week 24, Week 52|Pharmacokinetic population included all patients randomized to and received any dose of obinutuzumab given as study medication.|||ug/mL||Standard Deviation|Mean
2568731|NCT02550652|Secondary|Percent Change From Baseline in Circulating CD19-Positive B-Cell Levels|CD19+ B cell is a transmembrane protein that is encoded by the gene CD19.|Baseline, Week 2, Week 4, Week 12, Week 24, Week 52|Modified intent-to-treat population will include all randomized participants who have received any amount of study drug. Participants who received an incorrect therapy were reported under the treatment arm to which they were randomized.|||Percent change of cells/uL||Standard Deviation|Mean
2568732|NCT02550652|Secondary|Percentage of Participants With Anti-Drug Antibody (ADA) to Obinutuzumab|Antibodies are a blood protein produced in response to and counteracting a specific antigen.|From baseline to Week 52 (up to approximately 38 months)|The safety population was defined as all participants who have received at least one dose of study medication.|||percentage of participants|||Number
2568752|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in AST ≥10 Times ULN|Participants had AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of AST that were 10x ULN or greater were recorded. The AST ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
2571076|NCT02520310|Secondary|Forward Stroke Volume (FSV)|Defined as the volume of blood pumped from the left ventricle per heartbeat.|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2568733|NCT02550652|Secondary|Percentage of Participants With Adverse Events of Special Interest: Infusion Related Reactions, Infections, Thrombocytopenia and Neutropenia|Neutropenia is defined as low neutrophil count (ANC <1.0 x 109/L). Infusion related reaction is defined as a type of hypersensitivity reaction (pruritus, chills, diaphoresis, fever) that develops during or shortly after administration of a drug. Thrombocytopenia is defined as deficiency of platelets (<150 x 10^9/L) in the blood. Infections include all events of infections under the SOC of infections and infestations in this study.|From baseline to Week 52 (up to approximately 38 months)|The safety population was defined as all participants who have received at least one dose of study medication.|||percentage of participants|||Number
2568734|NCT02550652|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs, including AEs of Special Interest and AEs of Particular Interest, were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).|From Baseline up to Week 52 (up to approximately 38 months)|The safety population was defined as all participants who have received at least one dose of study medication.|||percentage of participants|||Number
2568735|NCT02550652|Secondary|Percentage of Participants Who Achieve Protocol Defined Third mCRR (mCRR3) at Week 52|mCRR3 is defined by normalization of serum creatine as evidenced by serum creatinine ≤ the ULN range of central laboratory values and urinary protein to creatinine ratio < 0.5.|Week 52|Modified intent-to-treat population will include all randomized participants who have received any amount of study drug. Participants who received an incorrect therapy were reported under the treatment arm to which they were randomized.|||percentage of participants|||Number
2568736|NCT02550652|Secondary|Percentage of Participants Who Achieve Protocol Defined Second mCRR (mCRR2) at Week 52|mCRR2 is defined by normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 RBCs/HPF and the absence of red cell casts), and urinary protein to creatinine ratio <0.5. Normalization of serum creatinine as evidenced by the following: Serum creatinine ≤15% above baseline if baseline (Day 1) serum creatinine is above the normal range of the central laboratory values or ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values.|Week 52|Modified intent-to-treat population will include all randomized participants who have received any amount of study drug. Participants who received an incorrect therapy were reported under the treatment arm to which they were randomized.|||percentage of participants|||Number
2568737|NCT02550652|Secondary|Percentage of Participants Who Achieve Protocol Defined Modified CRR (mCRR1) at Week 52|mCRR1 has got two components only, i.e. serum Creatinine and urinary protein to creatinine ratio. mCRR1 is defined by attainment of normalization of serum creatinine as evidenced by 1.) serum creatinine ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN or serum creatinine ≤15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine ≤ the ULN range of central laboratory values and 2.) Urinary protein to creatinine ratio <0.5.|Week 52|Modified intent-to-treat population will include all randomized participants who have received any amount of study drug. Participants who received an incorrect therapy were reported under the treatment arm to which they were randomized.|||percentage of participants|||Number
2568738|NCT02550652|Secondary|Change From Baseline in C4 Levels at Week 52|Complement C4 is a blood test that reflects activation of complement pathway associated with immune deposition in certain autoimmune diseases.|Baseline, Week 52|Modified intent-to-treat population will include all randomized participants who have received any amount of study drug. Participants who received an incorrect therapy were reported under the treatment arm to which they were randomized.|||g/L||Standard Deviation|Mean
2568739|NCT02550652|Secondary|Change From Baseline in Complement Component 3 (C3) Levels at Week 52|Complement C3 is a blood test that reflects activation of complement pathway associated with immune deposition in certain autoimmune diseases.|Baseline and Week 52|Modified intent-to-treat population will include all randomized participants who have received any amount of study drug. Participants who received an incorrect therapy were reported under the treatment arm to which they were randomized.|||g/L||Standard Deviation|Mean
2568740|NCT02550652|Secondary|Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody Levels at Week 52|Anti-dsDNA antibodies are a group of anti-nuclear antibodies targeting double stranded DNA.|Baseline and Week 52|Modified intent-to-treat population will include all randomized participants who have received any amount of study drug. Participants who received an incorrect therapy were reported under the treatment arm to which they were randomized.|||log IU/mL||Standard Deviation|Mean
2568741|NCT02550652|Secondary|Percentage of Participants With First Protocol Defined CRR Over the Course of 52 Weeks|CRR included normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 RBCs/HPF and the absence of red cell casts) and urinary protein to creatinine ratio < 0.5. Normalization of serum creatinine is defined as serum creatinine ≤ the ULN range of central laboratory values if baseline serum creatinine is above the ULN or serum creatinine ≤ 15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values. Percentage of participants with response at various time points were measured using Kaplan Meier method.|From Baseline to Week 52|Modified intent-to-treat population will include all randomized participants who have received any amount of study drug. Participants who received an incorrect therapy were reported under the treatment arm to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
2568753|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in ALT ≥10 Times ULN|Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of ALT that was 10x ULN or greater were recorded. The ALT ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
2568742|NCT02550652|Secondary|Percentage of Participants Who Achieve Protocol Defined CRR at Week 24|CRR defined as normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 red blood cells (RBCs)/high-power field (HPF) and the absence of red cell casts) and urinary protein to creatinine ratio < 0.5. Normalization of serum creatinine is defined as serum creatinine ≤ the upper limit of normal (ULN) range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN or serum creatinine ≤ 15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values.|Week 24|Modified intent-to-treat population will include all randomized participants who have received any amount of study drug. Participants who received an incorrect therapy were reported under the treatment arm to which they were randomized.|||percentage of participants|||Number
2568743|NCT02550652|Secondary|Percentage of Participants Who Achieve Protocol Defined Partial Renal Response (PRR) at Week 52|PRR defined as serum creatinine ≤15% above baseline value, no urinary red cell casts and either RBCs/HPF ≤ 50% above baseline or < 10 RBCs/HPF, 50% improvement in urine protein:creatinine ratio, with one of following conditions met: 1. If baseline urine protein:creatinine ratio is ≤ 3.0, then a urine protein:creatinine ratio of < 1.0. 2. If baseline protein:creatinine ratio is > 3.0, then a urine protein:creatinine ratio of < 3.0.|From baseline to Week 52|Modified intent-to-treat population will include all randomized participants who have received any amount of study drug. Participants who received an incorrect therapy were reported under the treatment arm to which they were randomized.|||percentage of participants|||Number
2568744|NCT02550652|Secondary|Percentage of Participants With First Protocol Defined Overall Response Over the Course of 52 Weeks|OR includes both CRR and partial renal response(PRR). CRR as defined in the primary outcome measure above. PRR defined as 50% improvement in upcr, with one of these conditions met: 1. If baseline upcr is ≤3.0, then upcr of <1.0. 2. If baseline pcr is > 3.0, then upcr of <3.0, serum creatinine ≤15% above baseline value, and no urinary red cell casts and either RBCs/HPF ≤50% above baseline or <10 RBCs/HPF. Percentage of participants with response at various time points were measured using Kaplan Meier method.|From baseline to Week 52 (up to approximately 38 months)|Modified intent-to-treat population will include all randomized participants who have received any amount of study drug. Participants who received an incorrect therapy were reported under the treatment arm to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
2568745|NCT02550652|Secondary|Percentage of Participants Who Achieve Protocol Defined Overall Response (OR) at Week 52|OR includes both CRR and partial renal response (PRR). CRR as defined in the primary outcome measure above. PRR defined as 50% improvement in urine protein:creatinine ratio, with one of following conditions met: 1. If baseline urine protein:creatinine ratio is ≤ 3.0, then urine protein:creatinine ratio of <1.0. 2. If baseline protein:creatinine ratio is > 3.0, then urine protein:creatinine ratio of <3.0, serum creatinine ≤15% above baseline value, and no urinary red cell casts and either RBCs/HPF ≤50% above baseline or <10 RBCs/HPF.|From baseline to Week 52|Modified intent-to-treat population will include all randomized participants who have received any amount of study drug. Participants who received an incorrect therapy were reported under the treatment arm to which they were randomized.|||percentage of participants|||Number
2568746|NCT02550652|Primary|Percentage of Participants Who Achieve Protocol Defined Complete Renal Response (CRR) at Week 52|Percentage of participants with normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 red blood cells (RBCs)/high-power field (HPF) and the absence of red cell casts) and urinary protein to creatinine ratio < 0.5. Normalization of serum creatinine is defined as serum creatinine ≤ the upper limit of normal (ULN) range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN or serum creatinine ≤ 15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values.|From baseline to Week 52|Modified intent-to-treat population will include all randomized participants who have received any amount of study drug. Participants who received an incorrect therapy were reported under the treatment arm to which they were randomized.|||percentage of participants|||Number
2568747|NCT02550288|Primary|Percentage of Participants Who Have Elevations in CK ≥10xULN and Drug-Related Muscle Symptoms|Participants had CK levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly-related to study drug were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
2568748|NCT02550288|Primary|Percentage of Participants Who Have Elevations in CK ≥10xULN With Muscle Symptoms|Participants had CK levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
2568749|NCT02550288|Primary|Percentage of Participants Who Have Elevations in Creatine Kinase (CK) ≥10xULN|Participants had creatine phosphokinase (CK) levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
2568750|NCT02550288|Primary|Percentage of Participants With Potential Hy's Law Condition|Percentage of Participants with Potential Hy's Law Condition (defined as serum ALT or serum AST elevations >3xULN, with serum alkaline phosphatase <2xULN and total bilirubin (TBL) ≥2xULN) was summarized. The ALT and AST ULNs were 40 U/L. The ULN for alkaline phosphatase was 359 IU/L and the ULN for total bilirubin was 1.2 mg/dL.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
2568751|NCT02550288|Primary|Percentage of Participants Who Have Consecutive Elevations in ALT and/or AST ≥10 Times ULN|Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 10x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
2568754|NCT02550288|Primary|Percentage of Participants Who Have Consecutive Elevations in ALT and/or AST ≥5 Times ULN|Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 5 x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
2568755|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in AST ≥5 Times ULN|Participants had AST levels assessed throughout the 12 week treatment period. Participants who had an assessment of AST that was 5x ULN or greater were recorded. AST ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
2568756|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in ALT ≥5 Times ULN|Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had an assessment of ALT that was 5x ULN or greater were recorded. The ALT ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
2568757|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in ALT and/or AST ≥3 Times ULN|Participants had ALT and AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 3 x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
2568758|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in Aspartate Aminotransferase (AST) ≥3 Times ULN|Participants had AST levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of AST that were 3 x ULN or greater were recorded. The AST ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
2568759|NCT02550288|Primary|Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal (ULN)|Participants had ALT levels assessed throughout the 12 week treatment period. Participants who had 2 consecutive assessments of ALT that were 3 x ULN or greater were recorded. The ALT ULN was 40 U/L.|up to 12 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
2568760|NCT02550288|Primary|Percentage of Participants Who Experience 1 or More Hepatitis-related AEs|Hepatitis-related AEs included Cholestasis, Cytolytic Hepatitis, Hepatic Cyst, Hepatic Failure, Hepatic Lesion, Hepatic Necrosis, Hepatitis, Hepatitis Cholestatic, Hepatitis Fulminant, Hepatitis Infectious, Hepatocellular Injury, Hepatomegaly, Jaundice, Jaundice Cholestatic.|up to 14 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
2568761|NCT02550288|Primary|Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs|Allergic Reaction or Rash AEs included Allergy to Arthropod Sting, Anaphylactoid Reaction, Anaphylactic Reaction, Anaphylatic Shock, Anaphylactoid Shock, Angioedema, Conjunctivitis Allergic, Contrast Media Reaction, Dermatitis, Dermatitis Allergic, Dermatitis Atopic, Dermatitis Bullous, Dermatitis Contact, Dermatitis Psoriasiform, Drug Hypersensitivity, Eczema, Eosinophila, Erythema, Eye Allergy, Face Oedema, Hypersensitivity, Mechanical Urticaria, Palmar Erythema, Periorbital Oedema, Photodermatosis, Photosensitivity Allergic reaction, Photosensitivity Reaction, Pigmentation Disorder, Pruritus, Pruritus Generalised, Rash, Rash Erythematous, Rash Follicular, Rash Generalised, Rash Maculo-Papular, Rash Papulosquamous, Rash Pruritic, Rash Pustular, Rash Vesicular, Rhinitis, Rhinitis Allergic, Rosacea, Skin Exfoliation, Skin Disorder, Skin Hyperpigmentation, Skin Lesion, Skin Mass, Skin Ulcer, Subcutaneous Nodule, Swelling Face, Systemic Lupus Erythematosus Rash, Urticaria.|up to 14 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
2568762|NCT02550288|Primary|Percentage of Participants Who Experience 1 or More Gallbladder-related AEs|Gallbladder-related AEs included Bile Duct Obstruction, Bile Duct Stone, Bile Duct Stenosis, Biliary Colic, Cholangitis, Cholecystectomy, Cholecystitis, Cholelithiasis, Gallbladder Disorder, Gallbladder Perforation, Hepatic Pain, and Hydrocholecystis.|up to 14 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
2568763|NCT02550288|Primary|Percentage of Participants Who Experience 1 or More Gastrointestinal-related Adverse Events (AEs)|Gastrointestinal-related AEs included all preferred terms within system organ class of Gastrointestinal Disorders except Chapped Lips and Toothache.|up to 14 weeks|All randomized participants who received at least 1 dose of actual study treatment.|||Percentage of Participants|||Number
2568764|NCT02550288|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12|Participants had LDL-C levels assessed at baseline and after 12 weeks of study drug administration. The change from baseline was calculated.|Baseline and Week 12|All participants who received at least 1 dose of study treatment, and had a baseline observation or at least 1 post-baseline observation. One participant who received misallocated study medication during placebo run-in period was excluded from the main population for the analysis of efficacy data.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2568765|NCT02550210|Secondary|Mean Resection Specimen Volume|Volumes will be measured and descriptive statistics will be employed. The specimen volume is determined by recording the water displacement and specimen scanning.|30 days from surgery||||cm3||Standard Deviation|Mean
2568766|NCT02550210|Secondary|The Distances Between the Specimen Edges as Determined by the Breast Cancer Locator and by the Supine MRI/Optical Scan/ Tracker System|Distances will be measured and descriptive statistics will be employed.|30 days||||cm||Standard Deviation|Mean
2568767|NCT02550210|Secondary|Positive Margin Rate|The positive margin rate as defined by standard pathologic evaluation of the entire specimen.|30 Days||||percentage|||Number
2568768|NCT02550210|Primary|The Distance Measured by Pathology From the Tumor Edge to the Center of the Ink Spots, as Marked by the Black Inked Pins.|Five measurements will be made per patient and the mean difference in distance will be derived between the palpated and the co-registered supine MRI-optical scan image predicted tumor edges. The BCL will be considered accurate if all 5 measurements are > 0 cm from the tumor edge.|30 Days||||cm||Standard Deviation|Mean
2568769|NCT02550197|Primary|Percentage of Participants Reporting Solicited Injection-Site or Systemic Reaction After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Solicited Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm. Grade 3 Solicited Systemic reactions: Fever, ≥ 39.0˚C; Headache, Malaise, Myalgia, and Shivering, Significant; prevents daily activity.|Day 0 up Day 7 post-vaccination|Solicited injection-site and systemic reactions were analyzed in the Safety Analysis Set.|||Percentage of Participants|||Number
2568770|NCT02550197|Primary|Percentage of Participants Reporting Solicited Reactions Listed in The Former Committee for Medicinal Products for Human Use Note for Guidance Within 3 Days After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|The solicited reactions evaluated were Injection-site Induration (≥50 mm for at least 4 consecutive days), Injection-site Ecchymosis (injection site bruising), Pyrexia (recorded temperature >38.0˚C for at least 1 day), Malaise, and Shivering (rigors).|Day 0 up Day 3 post-vaccination|Solicited reactions were analyzed in the Safety Analysis Set.|||Percentage of Participants|||Number
2568771|NCT02550197|Primary|Geometric Mean Titer Ratios of Influenza Virus Antibodies After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titer ratios of influenza antibodies were assessed in the Immunogenicity Analysis Set.|||Titer ratio||95% Confidence Interval|Geometric Mean
2568772|NCT02550197|Primary|Percentage of Participants Achieving Seroconversion or Significant Increase Against Influenza Antigens After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as titers < 10 (1/dil) on Day 0 and post-injection titer ≥ 40 (1/dil) on Day 21, and Significant increase was defined as titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-injection titer on Day 21.|Day 21 post-vaccination|Immunogenicity was assessed in the Immunogenicity Analysis Set.|||Percentage of Participants|||Number
2568773|NCT02550197|Primary|Percentage of Participants With Influenza Antibodies Titers < 10 (1/Dil) Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Immunogenicity was assessed in the Immunogenicity Analysis Set.|||Percentage of Participants|||Number
2568774|NCT02550197|Primary|Percentage of Participants Achieving Seroprotection Against Influenza Antigens Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 21.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroprotection was assessed in the Immunogenicity Analysis Set.|||Percentage of Participants|||Number
2568775|NCT02550197|Primary|Geometric Mean Titers of Influenza Antibodies Before and After Vaccination With a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route|Immunogenicity was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titers of influenza antibodies were assessed in the Immunogenicity Analysis Set.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2568776|NCT02550132|Primary|Vertebral Displacement of the Eighth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
2568777|NCT02550132|Primary|Vertebral Displacement of the Seventh Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
2568778|NCT02550132|Primary|Vertebral Displacement of the Sixth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
2568779|NCT02550132|Primary|Vertebral Displacement of the Eighth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
2568780|NCT02550132|Primary|Vertebral Displacement of the Seventh Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
2568781|NCT02550132|Primary|Vertebral Displacement of the Sixth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
2568782|NCT02550132|Primary|Vertebral Displacement of the Eighth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
2568783|NCT02550132|Primary|Vertebral Displacement of the Seventh Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
2568784|NCT02550132|Primary|Vertebral Displacement of the Sixth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
2568785|NCT02550132|Primary|Vertebral Displacement of the Eighth Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
2568786|NCT02550132|Primary|Vertebral Displacement of the Seventh Thoracic Vertebra|Absolute posterior to anterior vertebral displacement during the spinal manipulation in centimeter|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||cm||Standard Error|Mean
2568788|NCT02550132|Primary|Right T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
2568789|NCT02550132|Primary|Right T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
2568790|NCT02550132|Primary|Left T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
2568791|NCT02550132|Primary|Left T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 300N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
2568792|NCT02550132|Primary|Right T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
2568793|NCT02550132|Primary|Right T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
2568794|NCT02550132|Primary|Left T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
2568795|NCT02550132|Primary|Left T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 250N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
2568796|NCT02550132|Primary|Right T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
2568797|NCT02550132|Primary|Right T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
2568798|NCT02550132|Primary|Left T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
2568799|NCT02550132|Primary|Left T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 200N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
2568800|NCT02550132|Primary|Right T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
2568801|NCT02550132|Primary|Right T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
2568802|NCT02550132|Primary|Left T8 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
2568803|NCT02550132|Primary|Left T6 Normalized Root Mean Square (RMS) Value|Normalized amplitude (RMS) of surface electromyography response. The normalisation was achieved by dividing the obtained RMS by the RMS value before thrust application.|During the 150N spinal manipulation procedure, assessed up to 2 seconds following thrust onset||||ratio||Standard Error|Mean
2568804|NCT02550106|Secondary|Angioedema Activity Using the Angioedema Activity Score (AAS)|The Angioedema Activity Score (AAS) was completed by patients on a daily basis. The AAS is a validated questionnaire to determine the severity and impact of the angioedema episode. Te daily AAS values are added over 7 days before baseline and W12. Weekly AAS (AAS7) scores range from 0 to 105, with higher scores indicative of a higher disease activity.|baseline and week 12|FAS|||scores on a scale||Standard Deviation|Mean
2568805|NCT02550106|Secondary|The Dermatology Life Quality Index (DLQI)|The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is designed for people aged 16 years and above. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).|baseline and week 12|FAS|||scores on a scale||Standard Deviation|Mean
2568806|NCT02550106|Secondary|The Angioedema Quality of Life (AE-QoL)|"The angioedema Quality of Life Questionnaire is a valuable tool to assess changes of QoL impairment in angioedema patients.~The results of all the answered questions are summed up and transferred to a scale ranging from 0 to 100, with higher scores indicative of a higher QoL impairment"|baseline and week 12|FAS|||scores on a scale||Standard Deviation|Mean
2568807|NCT02550106|Secondary|The Quality of Life Using the Chronic Urticaria Quality of Life (CU-QoL) Questionnaire|"The Cu-QoL is a questionnaire collecting retrospective information over the last 2 weeks before baseline and W12.~The CU-QoL total score is transformed to range from 0 to 100, with higher scores indicating worse Health Related Quality of life."|baseline and week 12|FAS|||scores on a scale||Standard Deviation|Mean
2568808|NCT02550106|Secondary|Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 28, With or Without the Presence of Angioedema|The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control.|week 28|FAS|||scores on a scale||Standard Deviation|Mean
2568809|NCT02550106|Secondary|Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 24, With or Without the Presence of Angioedema|The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control|week 24|FAS|||scores on a scale||Standard Deviation|Mean
2568810|NCT02550106|Secondary|Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 20, With or Without the Presence of Angioedema|The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control.|week 20|FAS|||scores on a scale||Standard Deviation|Mean
2568811|NCT02550106|Secondary|Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 16, With or Without the Presence of Angioedema|The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control.|week 16|FAS|||scores on a scale||Standard Deviation|Mean
2568812|NCT02550106|Secondary|Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12|"The UCT is a questionnaire collecting retrospective information over the last 4 weeks before baseline and W12.~The UCT score ranges from 0 to 16 with higher scores reflecting lower control of the disease.~A score of ≥12 indicates well-controlled urticaria."|baseline and week 12|FAS|||scores on a scale||Standard Deviation|Mean
2568813|NCT02550106|Secondary|CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema|"A total score of UAS7 is calculated by adding for 7 days the daily UAS. The UAS7 is the sum of the daily UAS over 7 days before baseline and W12. The UAS7 score ranges from 0 to 42 with higher scores reflecting higher activity of the disease.~Scores were categorized into five diseases states : urticaria‐free (score =0), well‐controlled (scores 1-6), mild (scores 7-15), moderate (scores 16-27) and severe urticaria (scores 28-42)."|baseline and week 12|Full Analysis Set (FAS)|||scores on a scale||Standard Deviation|Mean
2568814|NCT02550106|Secondary|Percent of Participants With UAS7≤6 (Patients Achieving Disease Control), in Adult Patients With CSU, With or Without the Presence of Angioedema|2 patients with angioedema status were missing at baseline and not included|WEEK 12|"Full Analysis Set~2 patients with angioedema status missing at baseline were not included so that FAS = 83 + 51 + 2= 136"|||percent of participants||95% Confidence Interval|Number
2568815|NCT02550106|Primary|Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12|"Number of participants with an Urticaria Control Test score of greater than or equal to 12 at Week 12~The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control."|WEEK 12|(Full analysis set, LOCF)|||percent of participants||95% Confidence Interval|Number
2568816|NCT02549755|Primary|To Compare Changes in 11C-acetate Uptake at One and Three Months Following Radiotherapy With Pre-treatment Uptake of 11C-acetate|The single patient enrolled in the trial showed no uptake in the liver tumor on the pretreatment scan and was dropped from the trial.|At three months|||||||
2568817|NCT02549716|Secondary|Incidence of Vasospasm|The investigators will measure the incidence of vasospasm in patients with subarachnoid hemorrhage (SAH) who receive 1g Q6 of IV acetaminophen starting on post-bleed day 0 and continuing for 14 consecutive days (typical vasospasm window). Clinical vasospasm will be defined as the presence of new focal neurological deficits (motor or speech deficits) that developed after subarachnoid hemorrhage (SAH), a decrease in the Glasgow Coma Score (GCS) of 2 or more points for >6hrs, a new cerebral infarction unrelated to post-treatment (coiling or clipping) complications, re-bleed, progressive hydrocephalus, electrolyte or metabolic disturbance, or infection. The incidence of clinical vasospasm will be identified in the patients Electronic Medical Record (EMR) after the 14 day period.|Days 0-14 following diagnosis with subarachnoid hemorrhage.|Outcome measure was not analyzed because study was terminated early.||||||
2568818|NCT02549716|Secondary|Number of Febrile Periods|Patients in both IV and PO groups will have their temperatures taken at the times listed. This will help determine if route of entry of acetaminophen plays a significant role in the number of febrile periods.|Time = 0, 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes after first drug administration. Additionally, every 24 hours after time t=0 for 14 days (14 additional samples from both blood and CSF).|Outcome measure was not analyzed because study was terminated early||||||
2568819|NCT02549716|Secondary|Concentrations of Interleukin-1 (IL-1), Interleukin-6 (IL-6), and Thromboxane A-2 (TXA-2) in Cerebral Spinal Fluid (CSF) and Blood|Patients in both IV and PO groups will have samples taken from their Cerebral Spinal Fluid (CSF) and blood at the above times after acetaminophen is administered for the first time. They will then have additional samples taken every 24 hours following the time of first drug administration for 14 days. These samples will be examined to determine concentrations of Interleukin-1 (IL-1), Interleukin-6 (IL-6), and thromboxane A-2 (TXA-2) in both the Cerebral Spinal Fluid (CSF) and blood. This will enable the team to determine if route of entry of acetaminophen plays a significant role in the level of inflammatory markers in critically ill patients.|Time = 0, 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes after first drug administration. Additionally, every 24 hours after time t=0 for 14 days (14 additional samples from both blood and CSF).|Outcome measure was not analyzed because study was terminated early||||||
2568820|NCT02549716|Primary|Bioavailability of Acetaminophen in Cerebral Spinal Fluid (CSF) and Blood|Patients in both IV and PO groups will have samples taken from their Cerebral Spinal Fluid (CSF) and blood at the above times after acetaminophen is administered for the first time. They will then have additional samples taken every 24 hours following the time of first drug administration for 14 days. Patients will also have a sample collected every 35 hours (1 hour before the 6th loading dose) to determine the steady state level of acetaminophen.|Time = 0, 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes after first drug administration|Outcome measure was not analyzed because study was terminated early.||||||
2568821|NCT02549573|Other Pre-specified|Hospital Anxiety and Depression Scale - Change From Baseline in Depression|The Hospital Anxiety and Depression Scale is a 14-item Investigator-rated scale designed to determine levels of anxiety and depression in people with physical health problems. Seven items relate to anxiety and 7 items related to depression, where the scale ranges from 0 (best score possible) to 21 (worst score possible). A negative change from baseline represents a decrease in depression.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
2568822|NCT02549573|Other Pre-specified|Change From Baseline in Patient Global Impression of Severity (PGI-S)|Self reported (caregiver, if applicable) impression of the severity of the subject's illness on a 7-point scale ranging from normal (1) to among the most extremely ill subjects (7). A negative change from baseline represents a decrease in the severity of the subject's illness.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. One subject in APO+ group did not have an end of study assessment for PGI-S.|||units on a scale||Standard Deviation|Mean
2568823|NCT02549573|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S)|Investigator's impression of the severity of the subject's illness on a 7-point scale ranging from normal (1) to among the most extremely ill subjects (7). A negative change from baseline represents a decrease in the severity of the subject's illness.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
2568824|NCT02549573|Secondary|Change From Baseline in MDS-UPDRS Part I B|MDS-UPDRS Part I B is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 28 (worst score possible). A negative change from baseline represents an improvement in non-motor experiences of daily living (subject rated).|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
2568825|NCT02549573|Secondary|Change From Baseline in MDS-UPDRS Part IV|MDS-UPDRS Part IV is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 24 (worst score possible). A negative change from baseline represents fewer motor complications.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
2568826|NCT02549573|Secondary|Change From Baseline in MDS-UPDRS Part II|MDS-UPDRS Part II is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 52 (worst score possible). A negative change from baseline represents an improvement in motor experience of daily living.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
2568827|NCT02549573|Other Pre-specified|Change From Baseline in Number of Falls as Reported by the Subject in the Past 1 Week|Subject reported number of falls. A negative change from baseline represents a decrease in the frequency of falls.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||number of falls reported||Standard Deviation|Mean
2568828|NCT02549573|Other Pre-specified|Number of Participants in Each Category of Patient Global Impression of Change (PGI-C)|Self reported (caregiver, if applicable) impression of change in the subject's symptoms from baseline assessment visit to end of study assessment, on a 7-point scale ranging from much improved to very much worse.|After week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||Participants|||Count of Participants
2568829|NCT02549573|Other Pre-specified|Hospital Anxiety and Depression Scale - Change From Baseline in Anxiety|The Hospital Anxiety and Depression Scale is a 14-item Investigator-rated scale designed to determine levels of anxiety and depression in people with physical health problems. Seven items relate to anxiety and 7 items related to depression, where the scale ranges from 0 (best score possible) to 21 (worst score possible). A negative change from baseline represents a decrease in anxiety.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
2568830|NCT02549573|Other Pre-specified|Change From Baseline in Parkinson's Fatigue Scale (PFS-16)|PFS-16 is a subject reported scale evaluating physical effects of fatigue and the impact on daily function, with a minimum score of 16 and a maximum score of 80. A negative change from baseline represents an improvement in physical effects of fatigue and the impact on daily function.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
2568831|NCT02549573|Other Pre-specified|Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39)|PDQ-39 is a scale measuring subject reported aspects of functioning and well-being. Each of the 39 items is rated using a 5-points Likert scale, with 0 for never having difficulties/problems and 4 for all always having difficulties/problems. The total score is the sum of the 39 items, with a minimum score of 0 and a maximum score of 156. A negative change from baseline represents an improvement in functioning and well-being.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
2569205|NCT02546193|Secondary|Number of Participants Per Method of Induction Used|Method of induction: outpatient placement of Foley catheter vs. inpatient usual care induction (medication and/or Foley catheter at time of admission)|End of the third stage of labor, approximately 16 hours after admission||||Participants|||Count of Participants
2568832|NCT02549573|Secondary|Number of Participants in Each Category of Clinical Global Impression of Change (CGI-C)|Investigator's impression of change in the subject's symptoms from baseline assessment visit to end of study assessment, on a 7-point scale ranging from very much improved to very much worse.|After week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||Participants|||Count of Participants
2568833|NCT02549573|Secondary|Change From Baseline in MDS-UPDRS Part I A|MDS-UPDRS Part I A is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 24 (worst score possible). A negative change from baseline represents an improvement in non-motor experiences of daily living (investigator rated).|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
2568834|NCT02549573|Secondary|Change From Baseline in Montreal Cognitive Assessment (MoCA)|The MoCA is a validated, 30-point test (sum of the 6 domains) designed to assess several cognitive domains, including visuospatial abilities (5 points), naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (5 points), and orientation to time and place (6 points). Total MoCA scores higher than 26 indicate normal cognitive function. A positive change from baseline represents an improvement in cognitive function.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
2568835|NCT02549573|Secondary|Change From Baseline in 6-Minute Walk Test (6MWT)|Objective performance based measure of functional exercise capacity that measures the distance a subject can cover on a 30 meter flat walking area over 6 minutes. A positive change from baseline represents an improvement in the distance walked (ft) in 6 minutes.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||feet||Standard Deviation|Mean
2568836|NCT02549573|Secondary|Change From Baseline in Timed-Up-and-Go (TUG) Test|Test captures the amount of time for a subject to get up from an arm chair, walk 3 meters, turn around, walk back to chair, and sit. A negative change from baseline represents an improvement of physical function.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||seconds||Standard Deviation|Mean
2568837|NCT02549573|Secondary|Change From Baseline in Modified Physical Performance Test (M-PPT)|Investigator scale assessing 9 domains of physical functioning where total scores range from 0 to 28 with higher scores indicating better physical performance. A positive change from baseline represents an improvement in physical performance.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
2568838|NCT02549573|Secondary|Change From Baseline in Movement Disorder Societies Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination)|MDS-UPDRS Part III is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 72 (worst score possible). A negative change from baseline represents an improvement in motor function.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||units on a scale||Standard Deviation|Mean
2568839|NCT02549573|Primary|Change From Baseline in Activities-specific Balance Confidence (ABC) Scale|Scale from 0 to 100% where an increase in percent represents an improvement in balance confidence.|Baseline and after week 6|The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.|||percent change||Standard Deviation|Mean
2568840|NCT02549365|Secondary|Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) in Those Received LAIV|"Incidence of adverse events (AE) and serious adverse events (SAEs) in children receiving LAIV, with the following sub-analyses:~AEs occurring up to 72 hours after LAIV in participants with a history of atopy / asthma / recurrent wheezing, compared to non-atopic participants.~Wheezing / asthma symptoms in subjects given LAIV who have a past medical history of asthma or recurrent wheeze in the 4 weeks prior to vaccine administration vs the 3-4 week period after LAIV.~NB: AE data was NOT collected in household controls, as per protocol NB: AE delay not collected in Controls (as per protocol)"|Up to 1 month after LAIV administration|AE data was not collected in household controls, as per protocol|||Participants|||Count of Participants
2568841|NCT02549365|Secondary|Immune Response to LAIV|To assess the immune response to vaccine and non-vaccine influenza strains before and after a single dose of LAIV administration, with respect to i. serological measures (haemagglutination inhibition titre to specific influenza strain) ii. change in specific nasal IgA responses|Up to 6 weeks following administration of a single dose of LAIV|39 patients provided paired blood samples pre and post LAIV 89 patients provided paired oral fluid samples pre/post LAIV|||Participants|||Count of Participants
2568842|NCT02549365|Primary|Vaccine Efficacy|Vaccine efficacy will be assessed through documentation of the incidence of laboratory confirmed influenza and other respiratory viruses in the children receiving LAIV compared to unvaccinated sibling controls|During 2015/2016 influenza season - precise dates to be set by Public Health England as this varies annually. Approximate duration of 3 months||||Participants|||Count of Participants
2568843|NCT02549352|Secondary|Percent Reduction in AK Count in the Treatment Area Compared to Baseline|The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable (using multiple imputations to account for missing values). The table presents adjusted mean percent reduction at Week 8 from baseline.|At Week 8||||percentage of change||95% Confidence Interval|Mean
2568844|NCT02549352|Secondary|Percentage of Participants With Partial Clearance|"The number of clinically visible Actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1, Weeks 4, and Week 8.~Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.~The table shows the percentage of mean number of participants across imputations with partial clearance at Week 4."|At Week 4||||percentage of participants||95% Confidence Interval|Number
2571077|NCT02520310|Secondary|Forward Stroke Volume (FSV)|Defined as the volume of blood pumped from the left ventricle per heartbeat.|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2568845|NCT02549352|Secondary|Percentage of Participants With Partial Clearance|"The number of clinically visible Actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1, Weeks 4, and Week 8.~Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.~The table shows the percentage of mean number of participants across imputations with partial clearance at Week 8."|At Week 8||||percentage of participants||95% Confidence Interval|Number
2568846|NCT02549352|Primary|Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)|"The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1 (baseline), Weeks 4, and 8.~Complete clearance was defined as no clinically visible AKs in the treatment area.~The table shows the percentage of mean number of participants across imputations with complete clearance at Week 8."|At Week 8||||percentage of participants||95% Confidence Interval|Number
2568847|NCT02549339|Secondary|Percent Reduction in AK Count in the Treatment Area Compared to Baseline|The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable (using multiple imputations to account for missing values). The table presents adjusted mean percent reduction at Week 8 from baseline.|At Week 8||||percentage of reduction||95% Confidence Interval|Mean
2568848|NCT02549339|Secondary|Percentage of Participants With Partial Clearance (Multiple Imputation)|"The number of clinically visible AKs identified in the treatment area was recorded at Day 1, Week 4, and Week 8.~Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.~The table shows the percentage of mean number of participants across imputations with partial clearance."|At Week 4||||percentage of participants||95% Confidence Interval|Number
2568849|NCT02549339|Secondary|Percentage of Participants With Partial Clearance (Multiple Imputation)|"The number of clinically visible AKs identified in the treatment area was recorded at Day 1, Week 4, and Week 8.~Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.~The table shows the percentage of mean number of participants across imputations with partial clearance."|At Week 8||||percentage of participants||95% Confidence Interval|Number
2568850|NCT02549339|Primary|Complete Clearance of Actinic Keratosis (AK)|"The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1, Week 4, and Week 8.~Complete clearance was defined as no clinically visible AKs in the treatment area.~The table shows the percentage of mean number of subjects across imputations with complete clearance."|At Week 8||||percentage of participants||95% Confidence Interval|Number
2568851|NCT02549287|Primary|Devereaux Early Child Assessment-Attachment Sub-scale|"The Attachment sub-scale of the Devereaux Early Child Assessment (DECA) is made up of 8-18 items (depending on child's age) that assesses the child's attachment behavior. (Example question: Did the toddler accept comfort from a familiar adult). This subscale score generates a t-score of standardized norms from a sum of the 8-18 items on a 5-point scale (0=Never - 4=Very frequently). Theoretical range of means: 28-72; Actual range of means: 28-72. Higher ratings represent a higher degree of child attachment. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring below 52 were rated as low (n=101) and participants rating 52 and higher were rated as high (n=138)."|Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).|Data for four surveys were corrupted causing the Row population to differ from the Overall population. In addition, Some participants missed or refused to answer questions. Lastly, errors in survey branching based on child's age required discarding those responses which reduced the total number of participants analyzed.|||units on a scale||Standard Deviation|Mean
2568852|NCT02549287|Secondary|Family Resources Scale - Revised|"The Family Resources Scale - Revised is a 40-item scale that assesses the adequacy of family needs in four domains: basic needs, money, time for self, and time for family. (Example question: How well is the following need being met: House or apartment). A total count of resources needed out of 40 assessed. Resources were considered needed if the participant indicated the resource was 'Not at all' met, 'A little' met, or 'Sometimes' met (5-point scale: 1=Not at all - 5=Almost always). Theoretical range of means: 0-40; Actual range of means: 0-40. Higher ratings indicating a higher number of resources needed. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants with 9 or fewer needs not met were rated as low (n=152) and participants with 10 and higher needs not met were rated as high (n=132)."|Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).|Data for four surveys were corrupted causing the Row population to differ from the Overall population. In addition, Some participants missed or refused to answer questions.|||units on a scale||Full Range|Median
2568853|NCT02549287|Secondary|Confusion, Hubbub, and Order Scale (CHAOS)|"The CHAOS scale (Confusion, Hubbub, and Order) is a 15-item scale used to measure structure and chaos in the home environment. (Example question: There is very little commotion in our home). A total score generated by calculating a mean of all 15 items on a 4-point scale (1=Very much like your own home - 4=Not at all like your own home). Theoretical range of means: 1-4; Actual range of means: 1.0-2.7. Lower scores indicate less chaos. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 1.5 or below were rated as low (n=151) and participants rating higher than 1.5 were rated as high (n=133)."|Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).|Data for four surveys were corrupted causing the Row population to differ from the Overall population. In addition, Some participants missed or refused to answer questions.|||units on a scale||Full Range|Median
2568869|NCT02549040|Primary|Plasma Concentration of MK-1439 at 24 Hours Post-dose (C24hr) Following a Single Administration of MK-1439|During each of the 5 treatment periods, blood samples were collected 24 hours after dosing to determine C24hr after a single administration of MK-1439.|Periods 1 to 5: 24 hours post-dose|Participants who complied with the protocol sufficiently to ensure that the data exhibited the effects of treatment, according to the underlying scientific model.|||nM||Geometric Coefficient of Variation|Geometric Mean
2568854|NCT02549287|Secondary|Mother-Child Neglect Scale (MCNS)|"The Mother-Child Neglect Scale (MCNS) is a 22-item scale designed to assess caregiving behaviors in four domains: physical, cognitive, supervision, and emotional needs. (Example question: I make sure my child sees a doctor when he/she needs one). A total score generated by calculating a mean of the 22 items rated on a 4-point scale (1=Strongly Agree - 4=Strongly Disagree). Theoretical range of means: 1-4; Actual range of means: 1.2-3.9. Lower scores indicate less neglectful behaviors. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 3.65 and below were rated as low (n=139) and participants rating higher than 3.65 were rated as high (n=145)."|Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).|Data for four surveys were corrupted causing the Row population to differ from the Overall population. In addition, Some participants missed or refused to answer questions.|||units on a scale||Full Range|Median
2568855|NCT02549287|Primary|Devereaux Early Child Assessment-Initiative Sub-scale|"The Initiative sub-scale of the Devereaux Early Child Assessment (DECA) is made up of 11-18 items (depending on child's age) that assesses the child's initiative behavior. (Example question: Did the child do things for himself). This subscale score generates a t-score of standardized norms from a sum of the 11-18 items on a 5-point scale (0=Never - 4=Very frequently). Theoretical range of means: 28-72; Actual range of means: 28-72. Higher ratings represent a higher degree of child initiation. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring below 56 were rated as low (n=110) and participants rating 56 and higher were rated as high (n=118)."|Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).|Data for four surveys were corrupted causing the Row population to differ from the Overall population. In addition, Some participants missed or refused to answer questions. Lastly, errors in survey branching based on child's age required discarding those responses which reduced the total number of participants analyzed.|||units on a scale||Standard Deviation|Mean
2568856|NCT02549287|Primary|BSI-Global Severity Index|"The Brief Symptom Inventory is a 53-item scale designed to measure a range of emotional health states including depression, anxiety, somatization, and others. (Example question: How much were you distressed by nervousness or shakiness inside). The Global Severity Index calculated a mean of all of the BSI subscales which includes 53 items on a 5-point scale (0=Not at all—4=Extremely). Theoretical range of means: 0-4; Actual range of means: 0.0-3.5). Higher scores indicate higher existence of symptoms. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, females scoring below .77 and males scoring below .57 were rated as low (n=197) and females rating .78 and higher and males rating .58 and higher were rated as high (n=87)."|Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).|Data for four surveys were corrupted causing the Row population to differ from the Overall population.|||units on a scale||Full Range|Median
2568857|NCT02549287|Primary|Brief Symptom Inventory-Significant Case Percentage|"The Brief Symptom Inventory is a 53-item scale designed to measure a range of emotional health states including depression, anxiety, somatization, and others. (Example question: How much were you distressed by nervousness or shakiness inside). The 'significant case' definition from the BSI was used and includes those with elevated scores (higher than 2) on any of the subscales. The percentage of participants that were considered a 'significant case' is reports. The 'case' definition from the BSI, which includes elevation on any of the subscale. The Brief Symptom Inventory is a 53-item scale designed to measure a range of emotional health states including depression, anxiety, somatization, and others. A total score or the, Global Severity Index, is generated by calculating a mean of all 53 items; lower scores indicate lower levels of distress."|Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (follow-up).|Data for four surveys were corrupted causing the Row population to differ from the Overall population.|||Participants|||Count of Participants
2568858|NCT02549287|Primary|Protective Factors Survey-Family Functioning Sub-scale|"The Family Functioning sub-scale of the Protective Factors is made up of 5 items that assess family functioning. (Example question: My family pulls together when things are stressful). This subscale score is generated by calculating a mean of 5 items on a 7-point scale (1=Never - 7=Always). Theoretical range of means: 1-7; Actual range of means: 1-7. Higher scores indicate higher family functioning. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring below 6 were rated as low (n=146) and participants rating 6 and higher were rated as high (n=133)."|Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (follow-up).|Data for four surveys were corrupted causing the Row population to differ from the Overall population.|||units on a scale||Full Range|Median
2568859|NCT02549287|Primary|Protective Factors Survey-Parent Knowledge Sub-scale|"The Parent knowledge sub-scale of the Protective Factors is made up of 5 items that assess parent knowledge. (Example question: There are many times when I don't know what to do as a parent). This subscale score is generated by calculating a mean of 5 items on a 7-point scale (1=Never - 7=Always). Theoretical range of means: 1-7; Actual range of means: 3.4-7.0. Higher scores indicate higher parent knowledge. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring below 7 were rated as low (n=149) and participants rating 7 and higher were rated as high (n=133)."|Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (follow-up).|Data for four surveys were corrupted causing the Row population to differ from the Overall population.|||units on a scale||Full Range|Median
2568892|NCT02548845|Secondary|Length of Hospitalisation (Measured From the Start of the Hyponatraemia Episode to Discharge) for Patients Who Were and Were Not Treated in Adherence With the Algorithm||Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)||||Days||95% Confidence Interval|Median
2568860|NCT02549287|Primary|Parenting Stress Inventory - Short Form|"Parenting Stress Inventory - short form is a 36-item scale designed to measure stressors in parenthood including parental distress, dysfunctional interactions, and stressors related to having a difficult child. (Example question: Sometimes I feel like my child doesn't like me and doesn't want to be close to me). A total score generated by summing all 36 items on a 5-point scale (1=Strongly Agree - 5=Strongly Disagree). Theoretical total range: 36-180; Actual total range: 38-146. Lower scores represent more stress/dysfunction. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 71 or below were rated as low (n=136) and participants rating higher than 71 were rated as high (n=148)."|Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (follow-up).|Data for four surveys were corrupted causing the Row population to differ from the Overall population.|||units on a scale||Full Range|Median
2568861|NCT02549287|Primary|Parenting Young Children Scale-Setting Limits Sub-scale|"The Setting limits sub-scale of the Parenting Young Children Scale is made up of 7 items that assess limit setting (Example question: Stick to your rules and not change your mind). This subscale score is generated by calculating a mean of seven items on a 7-point scale (1=Not at all - 7=Almost Always). Theoretical range of means: 1-7; Actual range of means: 1-7. Higher scores represent higher degree of positive parenting skills. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 6.3 or below were rated as low (n=141) and participants rating higher than 6.3 were rated as high (n=143)."|Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (Follow-up).|Data for four surveys were corrupted causing the Row population to differ from the Overall population. In addition, Some participants missed or refused to answer questions.|||units on a scale||Full Range|Median
2568862|NCT02549287|Primary|Parenting Young Children Scale-Proactive Parenting Sub-scale|"The Proactive Parenting sub-scale of the Parenting Young Children Scale is made up of 7 items that assess proactive parenting (Example question: Avoid struggles with your child by giving clear choices). This subscale score is generated by calculating a mean of seven items on a 7-point scale (1=Not at all - 7=Almost Always). Theoretical range of means: 1-7; Actual range of means: 1-7. Higher scores represent higher degree of positive parenting skills. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 6 or below were rated as low (n=148) and participants rating higher than 6 were rated as high (n=136)."|Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (follow-up).|Data for four surveys were corrupted causing the Row population to differ from the Overall population. In addition, Some participants missed or refused to answer questions.|||units on a scale||Full Range|Median
2568863|NCT02549287|Primary|Parenting Young Children Scale-Supporting Positive Behavior Sub-scale|"The Supporting Positive Behavior sub-scale of the Parenting Young Children Scale is made up of 7 items that assess supporting positive behavior (Example question: Notice and praise your child's good behavior). This subscale score is generated by calculating a mean of seven items on a 7-point scale (1=Not at all - 7=Almost Always). Theoretical range of means: 1-7; Actual range of means: 1-7. Higher scores represent higher degree of positive parenting skills. Because the data were heavily skewed toward the positive end of the scale, the measure was dichotomized into high vs. low based on an approximate median split. Specifically, participants scoring 6 or below were rated as low (n=125) and participants rating higher than 6 were rated as high (n=159)."|Families were assessed at two time points: 1) after being invited into the study during a visit with their provider (Baseline) and, 2) approximately 6-months later (follow-up).|Data for four surveys were corrupted causing the Row population to differ from the Overall population. In addition, Some participants missed or refused to answer questions.|||units on a scale||Full Range|Median
2568864|NCT02549196|Secondary|Number of Participants With TEAEs Leading to Study Drug Discontinuation|Number of subjects who experienced any treatment-emergent adverse events (TEAEs) leading to study drug discontinuation|1-7 weeks||||Participants|||Count of Participants
2568865|NCT02549196|Primary|Number of Participants Who Reached the Maximum Allowed Dose (MAD) in Their Respective Cohort|Of the four cohorts with different dosing schedules for CPC-201, the cohort with the greatest proportion of participants to reach the donepezil MAD was determined to be the optimal administration regimen.|1-7 weeks|The MTD evaluable population was defined as all patients who completed the donepezil dose titration.|||Participants|||Count of Participants
2568866|NCT02549040|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours (AUC0-48 hr) Post-dose of MK-1439 Following a Single Administration of MK-1439|During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48 hours after dosing to determine AUC0-48hr after a single administration of MK-1439.|Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, and 48 hours post-dose|Participants who complied with the protocol sufficiently to ensure that the data exhibited the effects of treatment, according to the underlying scientific model.|||µM*h||Geometric Coefficient of Variation|Geometric Mean
2568867|NCT02549040|Primary|Number of Participants Who Discontinued Study Treatment Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Up to 4 days after last dose of study treatment (up to approximately 76 days)|All participants who received at least 1 administration of the trial drug.|||Participants|||Count of Participants
2568868|NCT02549040|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Up to 16 days after last dose of study treatment (up to approximately 92 days)|All participants who received at least 1 administration of the trial drug.|||Participants|||Count of Participants
2571078|NCT02520310|Secondary|Forward Stroke Volume (FSV)|Defined as the volume of blood pumped from the left ventricle per heartbeat.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2568870|NCT02549040|Primary|Maximum Plasma Concentration (Cmax) of MK-1439 Following a Single Administration of MK-1439|During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose to determine Cmax after a single administration of MK-1439.|Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose|Participants who complied with the protocol sufficiently to ensure that the data exhibited the effects of treatment, according to the underlying scientific model.|||nM||Geometric Coefficient of Variation|Geometric Mean
2568871|NCT02549040|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Last Time (AUC0-last) With Quantifiable MK-1439 Following a Single Administration of MK-1439|During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose to determine AUC0-last after a single administration of MK-1439.|Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose|Participants who complied with the protocol sufficiently to ensure that the data exhibited the effects of treatment, according to the underlying scientific model.|||μM*h||Geometric Coefficient of Variation|Geometric Mean
2568872|NCT02549040|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of MK-1439 Following a Single Administration of MK-1439|During each of the 5 treatment periods, blood samples were collected pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose to determine AUC0-inf after a single administration of MK-1439.|Periods 1 to 5 at the following time points: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, and 72 hours post-dose|Participants who complied with the protocol sufficiently to ensure that the data exhibited the effects of treatment, according to the underlying scientific model. Participants were excluded from descriptive statistics for AUC0-inf if there were insufficient data in the terminal phase to characterize half-life (t1/2).|||µM*h||Geometric Coefficient of Variation|Geometric Mean
2568873|NCT02549027|Secondary|Change From Baseline in CRT Following Single Doses of MK-6096 and Placebo|"CRT assessment used in this study is a two-choice, computer-controlled test in which the participant responds to stimulus words presented on the screen of a laptop computer. During the test either the word NO or the word YES is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 50 trials for which each stimulus word is chosen randomly with equal probability and there is a varying inter-stimulus interval. The mean reaction time of accurate responses is determined. The assessment is performed pre-dose and at 10 hours post dose. The outcome measure is change from baseline to post dose in reaction time."|Pre-dose and 10 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during MK-6096 dose in Period 5 and during administration of placebo in any period. 1 subject took placebo within Periods 1-4 and also in Period 5. Data for both administrations of placebo are included (i.e., for placebo, analysis includes 21 observations from 20 subjects)|||milliseconds||95% Confidence Interval|Mean
2568874|NCT02549027|Secondary|Change From Baseline in Choice Reaction Time (CRT) Following Single Doses of MK-1064 and Placebo|"CRT assessment used in this study is a two-choice, computer-controlled test in which the participant responds to stimulus words presented on the screen of a laptop computer. During the test either the word NO or the word YES is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 50 trials for which each stimulus word is chosen randomly with equal probability and there is a varying inter-stimulus interval. The mean reaction time of accurate responses is determined. The assessment is performed pre-dose and at 10 hours post dose. The outcome measure is change from baseline to post dose in reaction time."|Pre-dose and 10 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during administration of MK-1064 doses in Period 1-4 and during administration of placebo in Period 1-4|||milliseconds||95% Confidence Interval|Mean
2568875|NCT02549027|Secondary|WASO Following Single Doses of MK-6096 and Placebo|WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning.|1 to 9 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during MK-6096 dose in Period 5 and during administration of placebo in any period. 1 subject took placebo within Periods 1-4 and also in Period 5. Data for both administrations of placebo are included (i.e., for placebo, analysis includes 21 observations from 20 subjects)|||minutes||95% Confidence Interval|Geometric Mean
2568876|NCT02549027|Secondary|Wake Time After Sleep Onset (WASO) Following Single Doses of MK-1064 and Placebo|WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning.|1 to 9 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during administration of MK-1064 doses in Period 1-4 and during administration of placebo in Period 1-4|||minutes||95% Confidence Interval|Geometric Mean
2568877|NCT02549027|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.|Up to 14 days after the last dose of study drug (Up to approximately 42 days)|All Participants as Treated – all participants who received at least one dose of study drug.|||participants|||Number
2568878|NCT02549027|Primary|Number of Participants With Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.|Up to 14 days after the last dose of study drug (Up to approximately 42 days)|All Participants as Treated – all participants who received at least one dose of study drug.|||participants|||Number
2569457|NCT02542072|Secondary|Vision Quality|Vision quality of comfilcon A and samfilcon A lenses. Scale 0-10, 0=completely dissatisfied, 10=completely satisfied.|Baseline, 2 weeks, 4 weeks|Number of participants analyzed differ from participant flow due to protocol deviations.|||units on a scale||Standard Deviation|Mean
2568879|NCT02549027|Primary|LPS Following Single Doses of MK-6096 and Placebo|LPS is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.|1 to 9 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during MK-6096 dose in Period 5 and during administration of placebo in any period. 1 subject took placebo within Periods 1-4 and also in Period 5. Data for both administrations of placebo are included (i.e., for placebo, analysis includes 21 observations from 20 subjects)|||minutes||95% Confidence Interval|Geometric Mean
2568880|NCT02549027|Primary|Latency to Persistent Sleep (LPS) Following Single Doses of MK-1064 and Placebo|LPS is measured during overnight sleep laboratory (polysomnography [PSG]) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.|1 to 9 hours post dose, within each treatment period|Per-Protocol. Note: Data included are those obtained from subjects during administration of MK-1064 doses in Period 1-4 and during administration of placebo in Period 1-4|||minutes||95% Confidence Interval|Geometric Mean
2568881|NCT02549014|Secondary|Apparent Terminal Half-life (t1/2) Following Single Doses of MK-1064|t1/2 is the elimination half-life of study drug. t1/2 is the time it takes for half of the study drug (MK-1064) in the blood plama to dissipate.|Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)|All participants who received ≥1 dose of MK-1064.|||hr||Standard Deviation|Geometric Mean
2568882|NCT02549014|Secondary|Time to Cmax (Tmax) Following Single Doses of MK-1064|Tmax is the amount of time to reach maximum (peak) plasma drug concentration following drug administration.|Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)|All participants who received ≥1 dose of MK-1064.|||hr||Full Range|Median
2568883|NCT02549014|Secondary|Maximum Observed Plasma Concentration (Cmax) Following Single Doses of MK-1064|Cmax is the maximum (peak) concentration of study drug (MK-1064) observed in blood plasma.|Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post dose (Periods 3 and 4 only)|All participants who received ≥1 dose of MK-1064.|||µmol/L||Standard Deviation|Geometric Mean
2568884|NCT02549014|Secondary|Area Under the Plasma Drug Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC0-last) Following Single Doses of MK-1064|AUC0-last is the area under the plasma concentration-time curve from time zero to time of last measurable concentration. It is is a measure of the amount of study drug (MK-1064) in the blood plasma from pre-dose until the last measurable concentration of study drug could be determined.|Pre-dose and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24 and 48 hours post dose (all Periods); 72 hours post-dose (Periods 3 and 4 only)|All participants who received ≥1 dose of MK-1064.|||µmol*hr/L||Standard Deviation|Geometric Mean
2568885|NCT02549014|Primary|Average Plasma Concentration From Time Zero to 4 Hours (Area Under the Plasma Drug Concentration-time Curve From Time Zero to 4 Hours [AUC0-4hr]) Following Single Doses of MK-1064|AUC0-4hr is the area under the plasma concentration-time curve from time 0 to 4 hours post-dose. This is a measure of the average amount of study drug (MK-1064) in the blood plasma over a period of 4 hours after the dose.|Pre-dose and 0.5, 1, 2, 3 and 4 hours post-dose|All participants who received ≥1 dose of MK-1064.|||µmol*hr/L||Standard Deviation|Geometric Mean
2568886|NCT02549014|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.|Up to 14 days after the last dose of study drug (Up to approximately 60 days)|All participants who received ≥1 dose of study drug.|||Participants|||Number
2568887|NCT02549014|Primary|Number of Participants Who Experienced One or More Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, is also an AE.|Up to 14 days after the last dose of study drug (Up to approximately 60 days)|All participants who received ≥1 dose of study drug.|||Participants|||Number
2568888|NCT02548962|Secondary|Duration of Response (DOR)|The time interval between the date of initial documentation of a response and the date of first documented evidence of progressive disease, death, or date of censoring for the subjects not progressed/died. The censoring date is the last adequate tumor assessment date.|14 Months|Median was not reached for Phase 1: Dose Finding (560 mg). Median value provided here was the median and range (min and max).|||Months||Full Range|Median
2568889|NCT02548962|Secondary|Clinical Benefit Response (CBR)|The clinical benefit response, defined as the proportion of subjects achieving a best overall response of MR or better per investigator assessment per IMWG at or prior to initiation of subsequent anticancer therapy.|14 Months||||Participants|||Count of Participants
2568890|NCT02548962|Primary|Overall Response Rate (ORR) According to the IMWG Response Criteria Per Investigator Assessment|The overall response rate, defined as the proportion of subjects achieving a best overall response of PR or better per investigator assessment per IMWG at or prior to initiation of subsequent anticancer therapy|14 Months||||Participants|||Count of Participants
2568891|NCT02548845|Secondary|Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Hours)|Improvement is defined as a change in the baseline sodium level category (mild, moderate or severe) from a worse category to a better category or eunatraemia. Note that the time to improvement of sodium levels was defined as the first date/time of improvement of sodium levels - date/time of collection of serum sodium levels at baseline (for patients where there was an improvement in sodium levels) or as the final date/time of collection of serum sodium levels - date/time of collection of serum sodium levels at baseline (for patients that did not achieve an improvement in sodium levels [censored patients]).|Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)|The overall number of patients analysed represents the number of participants for which the data (time in hours) was available. As a retrospective chart review, there were some missing data in this outcome measure (time of improvement in this case)|||hours||95% Confidence Interval|Median
2568893|NCT02548845|Secondary|Time to Initiation or Re-initiation of Chemotherapy (Since the Start of the Hyponatraemia Episode) in Patients Candidate for Chemotherapy Who Were and Were Not Treated in Adherence With the SEOM Algorithm.||Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)|In this analysis, only the 22 patients who were candidate for chemotherapy during the study period were included, this explains the difference with the total number of participants.|||Hours||95% Confidence Interval|Median
2568894|NCT02548845|Secondary|Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Days)|Improvement is defined as a change in the baseline sodium level category (mild, moderate or severe) from a worse category to a better category or eunatraemia. Note that the time to improvement of sodium levels was defined as the first date/time of improvement of sodium levels - date/time of collection of serum sodium levels at baseline (for patients where there was an improvement in sodium levels) or as the final date/time of collection of serum sodium levels - date/time of collection of serum sodium levels at baseline (for patients that did not achieve an improvement in sodium levels [censored patients]).|Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)|The overall number of patients analysed represents the number of participants for which the data (time in days) was available. As a retrospective chart review, there were some missing data in this outcome measure (date of improvement in this case)|||Days||95% Confidence Interval|Median
2568895|NCT02548845|Primary|Number of Patients Managed According to the SEOM Algorithm (as a Result Adherence to the Algorithm Will be the % of These Patients Among the Total Number of Patients)|Adherence to the algorithm will be evaluated using a pre-defined decision tree that will be provided in the electronic case report form (eCRF) and will be completed by the investigator|Participants will be followed for the duration of hospital stay, an expected average of 4 days (follow-up will stop after a maximum of 6 weeks)||||Participants|||Count of Participants
2568896|NCT02548754|Secondary|Markers of Inflammation|Serum levels of inteleukin 6|6 months||||pg/ml||Inter-Quartile Range|Median
2568897|NCT02548754|Secondary|Markers of Inflammation|Serum levels of tumor necrosis factor-alpha|6 months||||pg/ml||Inter-Quartile Range|Median
2568898|NCT02548754|Primary|Atrial Fibrillation Burden|Percent time spent in atrial fibrillation|6 months||||Percent time spent in atrial fibrillatio||Inter-Quartile Range|Median
2568899|NCT02548728|Secondary|Speilberger State and Trait Anxiety Inventory|The Spielberger State and Trait Anxiety Inventory (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of state anxiety, which evaluates how the subject feels currently (transient anxiety). The State scale consists of 20 questions, each question rated 1-4, and a higher score indicates greater anxiety. Total score ranges from 20 (no anxiety) to 80 (maximum anxiety).|Daily up to 5 days|STAI data not collected due to subject noncompliance in adhering to form completion.||||||
2568900|NCT02548728|Secondary|AUC in Visual Analog Scale (VAS) Score for Craving on Days 1 to 5 Inclusive|"Craving levels were measured using the VAS score on Days 1 to 5; the VAS scores range from 0 (no cravings) to 100 (most intense craving I have ever had). Note that the value of AUC is a product of time multiplied by VAS scale score thus the numeric values are higher than the highest value on the scale."|Days 1-5, the AUC includes data starting from time 0 hours up to 120 hours post-dose.||||Average VAS score * hours||Standard Deviation|Mean
2568901|NCT02548728|Secondary|AUC in Subjective Opiate Withdrawal Scale (SOWS) Total Score on Days 1 to 5 Inclusive|Least squares mean AUC day 1 pre-dose through Day 5 in SOWS; SOWS scores range from 0-64, with a lower score being more favorable|5 days|SOWS data not collected due to subject noncompliance in adhering to form completion.||||||
2568902|NCT02548728|Primary|Area Under the Curve (AUC) in COWS Total Score on Days 1 to 5 Inclusive|The Clinical Opiate Withdrawal Scale (COWS) is an 11-item, observer-rated tool for quantifying withdrawal symptoms. Each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points). Lower scores are more favorable.|From days 1-5, the measure includes scores starting at time 0 through the maximal final time of up to 120 hours.||||Average COWS score * hours||Standard Error|Mean
2568903|NCT02548650|Secondary|Maximal Platelet Aggregation in Non-DM|Comparison of maximal platelet aggregation (%) measured by light transmittance aggregometry between between triple (vorapaxar plus DAPT) and dual (vorapaxar plus clopidogrel) therapy in non-diabetic patients|30 days||||percentage of aggregation||Standard Deviation|Mean
2568904|NCT02548650|Primary|Maximal Platelet Aggregation in DM|Comparison of maximal platelet aggregation (%) measured by light transmittance aggregometry between between triple (vorapaxar plus DAPT) and dual (vorapaxar plus clopidogrel) therapy in diabetic patients|30 days|The PD population included all patients with PD data and without a major protocol deviation thought to affect the PD effects of vorapaxar, aspirin and clopidogrel. Two patients were not compliant with medications and therefore excluded from the PD analysis. Some patients did not have primary end point data but were considered for other analyses.|||percentage of aggregation||Standard Deviation|Mean
2568905|NCT02548585|Secondary|Percent Change From Baseline in Incretin AUC0-4h After MMT to EOT (Cohorts 1, 2, 3, and 4)|Mixes-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time). Incretins included glucagon-like peptide-1 (GLP-1; active and inactive both), glucagon, and gastric inhibitory peptide (GIP).|0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4)|PD population included all participants who received at least 1 dose of study drug and had at least 1 post-MMT PD blood sample.|||Percent change||Standard Deviation|Mean
2568955|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Month 6 + 6 Days|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 Days time-point.|||Percentage of participants|||Number
2568906|NCT02548585|Secondary|Percent Change From Baseline in C-peptide AUC0-4h After MMT to EOT (Cohorts 1, 2, 3, and 4)|Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time).|0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4)|PD population included all participants who received at least 1 dose of study drug and had at least 1 post-MMT PD blood sample.|||Percent change||Standard Deviation|Mean
2568907|NCT02548585|Secondary|Percent Change From Baseline in Proinsulin AUC0-4h After MMT to EOT (Cohorts 1, 2, 3, and 4)|Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time).|0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4)|PD population included all participants who received at least 1 dose of study drug and had at least 1 post-MMT PD blood sample.|||Percent change||Standard Deviation|Mean
2568908|NCT02548585|Secondary|Percent Change From Baseline in Insulin AUC0-4h After MMT to EOT (Cohorts 1, 2, 3, 4, 5, and 6)|Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time).|0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4; Day 22 for Cohort 5; and Day 17 for Cohort 6)|PD population included all participants who received at least 1 dose of study drug and had at least 1 post-MMT PD blood sample.|||Percent change||Standard Deviation|Mean
2568909|NCT02548585|Secondary|Number of Participants With Positive Anti-drug Antibodies to MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)||Day 1 up to 7-14 days post-last dose of MEDI0382 for all cohorts (Approximately 60 days)|ATP included all participants who received any study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2568910|NCT02548585|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)||C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and additional 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose|PK population included all participants who received at least 1 dose of study drug and had at least one PK sample taken that was above the lower limit of quantitation.|||hr||Full Range|Median
2568911|NCT02548585|Secondary|Minimum Observed Plasma Concentration (Cmin) of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)||C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and additional 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose|PK population included all participants who received at least 1 dose of study drug and had at least one PK sample taken that was above the lower limit of quantitation.|||ng/mL||95% Confidence Interval|Geometric Mean
2568912|NCT02548585|Secondary|Maximum Observed Plasma Concentration (Cmax) of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)||C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and additional 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose|PK population included all participants who received at least 1 dose of study drug and had at least one PK sample taken that was above the lower limit of quantitation.|||ng/mL||95% Confidence Interval|Geometric Mean
2568913|NCT02548585|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)||C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and additional 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose|PK population included all participants who received at least 1 dose of study drug and had at least one PK sample taken that was above the lower limit of quantitation.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2568914|NCT02548585|Secondary|Area Under the Concentration Time Curve From Time Zero to End of Dosing Interval (AUC[0-tau]) of MEDI0382 (Cohorts 1, 2, 3, 4, 5, and 6)||C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose and 48 hr post dose for C1D7, C2D11, C3D15; C4 (D9 & D41), C5 (D16 & D22), and C6 (D11 & D17): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose|PK population included all participants who received at least 1 dose of study drug and had at least one PK sample taken that was above the lower limit of quantitation.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2568915|NCT02548585|Secondary|Accumulation Ratio (Rac) of MEDI0382 (Cohorts 1, 2, and 3)|Accumulation ratio was calculated as, Rac obtained from area under the curve from time zero to end of dosing interval (AUC[0-tau]) of Nth day divided by AUC(0-tau) of Day 1.|C1 (D1 & D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose; and additional 48 hr post C1D7, C2D11, C3D15 dose|PK population included all participants who received at least 1 dose of study drug and had at least one PK sample taken that was above the lower limit of quantitation.|||Ratio||95% Confidence Interval|Geometric Mean
2568916|NCT02548585|Secondary|Terminal Elimination Half Life (t1/2) of MEDI0382 (Cohorts 1, 2, and 3)|Terminal elimination half Life is the time measured for the plasma concentration of MEDI0382 to decrease by one half.|Cohort (C) 1 (Day [D] 1 and [&] D7), C2 (D5 & D11), and C3 (D9 & D15): pre-dose & 0.5, 1, 2, 4, 6, 8, 12, 24 hr post dose; and additional 48 hr post C1D7, C2D11, C3D15 dose|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study drug and had at least one PK sample taken that was above the lower limit of quantitation.|||hr||95% Confidence Interval|Geometric Mean
2568917|NCT02548585|Secondary|Number of Participants With Any Suicidal Behaviour as Assessed by C-SSRS Score (Cohorts 4, 5, and 6)|The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behaviour of participants. Yes/No responses are mapped to C-SSRS to assess whether participant experienced suicidal behaviour and suicidal ideation. Suicidal behaviour questions includes preparatory acts or behaviour, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation questions includes wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act (without specific plan), and active suicidal ideation with specific plan and intent. Participants with yes response to any category for suicidal behaviour were reported below.|Cohort 4: Day -1, and Days 13, 20, 27, 34, and 40; Cohort 5: Day -1 and Day 7-14 post last dose of MEDI0382 (approximately 36 days); Cohort 6: Day -1 and Day 7-14 post last dose of MEDI0382 (approximately 31 days)|ATP included all participants who received any study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2568918|NCT02548585|Secondary|Number of Participants With Any Suicidal Ideation as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score (Cohorts 4, 5, and 6)|The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behaviour of participants. Yes/No responses are mapped to C-SSRS to assess whether participant experienced suicidal behaviour and suicidal ideation. Suicidal behaviour questions includes preparatory acts or behaviour, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation questions includes wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act (without specific plan), and active suicidal ideation with specific plan and intent. Participants with yes response to any category for suicidal ideation were reported below.|Cohort 4: Day -1, and Days 13, 20, 27, 34, and 40; Cohort 5: Day -1 and Day 7-14 post last dose of MEDI0382 (approximately 36 days); Cohort 6: Day -1 and Day 7-14 post last dose of MEDI0382 (approximately 31 days)|ATP included all participants who received any study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2568919|NCT02548585|Secondary|Number of Participants With Abnormal Clinical Laboratory Reported as TEAEs|TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 28 days after the last study dose of each cohort (approximately 60 days). Number of participants with TEAEs related to laboratory abnormalities were reported.|From Day 1 to follow-up period (28 days after the last study dose for each cohort [approximately 60 days])|ATP included all participants who received any study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2568920|NCT02548585|Secondary|Number of Participants With Abnormal 12 Lead Electrocardiogram (ECG) Reported as TEAEs|TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 28 days after the last study dose of each cohort (approximately 60 days). Number of participants with TEAEs related to ECG abnormalities were reported.|From Day 1 to follow-up period (28 days after the last study dose for each cohort [approximately 60 days])|ATP included all participants who received any study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2568921|NCT02548585|Secondary|Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs|TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 28 days after the last study dose of each cohort (approximately 60 days). Number of participants with TEAEs related to vital signs and physical examination abnormalities were reported.|From Day 1 to follow-up period (28 days after the last study dose for each cohort [approximately 60 days])|ATP included all participants who received any study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2568922|NCT02548585|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. Serious adverse events (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, life-threatening, a congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 28 days after the last study dose of each cohort (approximately 60 days).|From Day 1 to follow-up period (28 days after the last study dose for each cohort [approximately 60 days])|As-treated Population (ATP) included all participants who received any study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2568923|NCT02548585|Secondary|Percent Change From Baseline in Glucose Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24h) After MMT to the EOT (Cohorts 1, 2, 3, 4, 5, and 6)|Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time).|0 minutes before; and 15, 30, 45, 60, 90, 120, 180, 240 minutes, and 24 hrs post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 41 for Cohort 4; Day 22 for Cohort 5; and Day 17 for Cohort 6)|PD population included all participants who received at least 1 dose of study drug and had at least 1 post-MMT PD blood sample.|||Percent change||Standard Deviation|Mean
2568956|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Month 6 + 6 Days.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 Days time-point.|||Percentage of participants|||Number
2568924|NCT02548585|Secondary|Change From Baseline in Fasting Glucose Prior to MMT to the EOT (Cohorts 1, 2, 3, 4, 5, and 6)|Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time).|Cohort 1: Baseline (Day-1) to EOT (Day7); Cohort 2: Baseline (Day-1) to EOT (Day11); Cohort 3: Baseline (Day-1) to EOT (Day15); Cohort 4: Baseline (Day-1) to EOT (Day41); Cohort 5: Baseline (Day-1) to EOT (Day22); Cohort 6: Baseline (Day-1) to EOT (Day17)|PD population included all participants who received at least 1 dose of study drug and had at least 1 post-MMT PD blood sample.|||mg/dL||Standard Deviation|Mean
2568925|NCT02548585|Secondary|Change From Baseline in Fructosamine to the EOT (Cohorts 4, 5, and 6)||Cohort 4: Baseline (Day -2) to EOT (Day 41); Cohort 5: Baseline (Day -2) to EOT (Day 22); Cohort 6: Baseline (Day -2) to EOT (Day 17)|ITT population included all participants who were randomized and received any study drug and analyzed according to the initial randomization. Participants who did not complete the treatment were not included in this analysis.|||micromol/L||Standard Deviation|Mean
2568926|NCT02548585|Secondary|Percent Change From Baseline in Hemoglobin A1c (HbA1c) to the EOT (Cohorts 4, 5, and 6)||Cohort 4: Baseline (Day -2) to EOT (Day 42); Cohort 5: Baseline (Day -2) to EOT (Day 22); Cohort 6: Baseline (Day -2) to EOT (Day 17)|ITT population included all participants who were randomized and received any study drug and analyzed according to the initial randomization. Participants who did not complete the treatment were not included in this analysis.|||Percent change||Standard Deviation|Mean
2568927|NCT02548585|Secondary|Change From Baseline in Body Weight to the EOT (Cohorts 1, 2, 3, 5, and 6)||Cohort 1: Baseline (Day 1) to EOT (Day 8); Cohort 2: Baseline (Day 1) to EOT (Day 12); Cohort 3: Baseline (Day 1) to EOT (Day 16); Cohort 5: Baseline (Day 1) to EOT (Day 22); Cohort 6: Baseline (Day 1) to EOT (Day 17)|ITT population included all participants who were randomized and received any study drug and analyzed according to the initial randomization. Participants who did not complete the treatment were not included in this analysis.|||Kg||Standard Deviation|Mean
2568928|NCT02548585|Secondary|Percent Change From Baseline in MMT Glucose AUC0-4h to the EOT (Cohorts 1, 2, 3, 5, and 6)|Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hrs after consumption of the standardized meal (with no additional food intake during this time).|0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post SMI on Baseline (Day -1) and EOT (Day 7 for Cohort 1; Day 11 for Cohort 2; Day 15 for Cohort 3; Day 22 for Cohort 5; and Day 17 for Cohort 6)|PD population included all participants who received at least 1 dose of study drug and had at least 1 post-MMT PD blood sample.|||Percent change||Standard Deviation|Mean
2568929|NCT02548585|Primary|Change From Baseline in Body Weight to the EOT (Cohort 4)||Baseline (Day 1) and EOT (Day 42)|Intent-to-treat (ITT) population included all participants who were randomized and received any study drug and analyzed according to the initial randomization.|||Kilograms (Kg)||Standard Deviation|Mean
2568930|NCT02548585|Primary|Percent Change From Baseline in Mixed-meal Test (MMT) Glucose Area Under the Concentration-time Curve From Time 0 to 4 Hours to the End of Treatment (EOT) (Cohort 4)|Mixed-meal test involved consumption of a standardized meal (nutritional supplement containing the components of fat, carbohydrate and protein, which make up a standard MMT) within 5 minutes, and timed serial blood samples were obtained for measurement of glucose and parameters related to glucose metabolism just before and 4 hours (hrs) after consumption of the standardized meal (with no additional food intake during this time).|0 minutes before; and 15, 30, 45, 60, 90, 120, 180, and 240 minutes post standardized meal intake (SMI) on Baseline (Day -1) and EOT (Day 41)|Pharmacodynamic (PD) population included all participants who received at least 1 dose of study drug and had at least 1 post-MMT PD blood sample.|||Percent change||Standard Deviation|Mean
2568931|NCT02548455|Primary|Number of Patients Free From LV Lead-related Complications Through 3 Months|A complication is defined as a Serious Adverse Device Effect related to the Quartet 1457Q lead. A Serious Adverse Device Effect is an event related to the use of a medical device that led to death, a life-threatening illness or injury, a permanent impairment to a body structure or a body function, an in-patient or prolonged hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body, a malignant tumor OR fetal distress, fetal death or a congenital abnormality or birth defect.|3 months|The first 94 subjects who underwent an attempted implant of the Quartet 1457Q lead and either completed a 3-month follow-up visit, withdrew from the study or died prior to the 3-month follow-up visit.|||Participants|||Count of Participants
2568932|NCT02548312|Secondary|"Number of Participants Who Are Extremely Likely to Change Practice on the Basis of the Article (Scored a 10), for Those Currently Treating the Relevant Condition"|"Measured on a single-item 10-point Likert scale from (1) not at all likely to (10) extremely likely. Higher scores indicate more likely to change practice. Min score = 1, max score =10.~Readers asked to complete the study questionnaire immediately after reading the review article."|Outcome measure will be assessed only at the time of the intervention (0 weeks)|Analysis only includes subset that indicated they currently treat gout/dyspepsia and own practice differed from recommendations given in the review.|||Participants|||Count of Participants
2568933|NCT02548312|Secondary|Interest in the Article.|"Measured on a single-item 10-point Likert scale from (1) not at all interesting to (10) extremely interesting. Higher scores indicate more interest. Min score = 0, max score =10.~Readers will be asked to complete the study questionnaire immediately after reading the review article."|Outcome measure will be assessed only at the time of the intervention (0 weeks)|One participant in the Group 'Dyspepsia review- competing interest statement 2', 'Dyspepsia review- statement 3', 'Gout review- statement 4' did not respond to the question related to this outcome. Hence, for this outcome the numbers analyzed= 92, 90 and 95 respectively (however n=93, 91 and 96 in participant flowchart).|||score on a scale||95% Confidence Interval|Mean
2568989|NCT02547987|Primary|Pathologic Complete Response|This is the complete disappearance of invasive cancer in the breast at the time of surgery|At the time of definitive surgery (approximately 4-5 months after beginning chemotherapy)||||Participants|||Count of Participants
2568934|NCT02548312|Secondary|Importance of the Article.|"Measured on a single-item 10-point Likert scale from (1) not at all important to (10) extremely important. Higher scores indicate more importance. Min score = 0, max score =10.~Readers will be asked to complete the study questionnaire immediately after reading the review article."|Outcome measure will be assessed only at the time of the intervention (0 weeks)|One participant in the Group 'Gout review- competing interest statement 4' and one participant in 'Dyspepasia review- competing interest statement 3' did not respond to the question related to this outcome. Hence, for this outcome the numbers analyzed= 90 and 95 respectively (n=91 and n=96 in the participant flow chart).|||score on a scale||95% Confidence Interval|Mean
2568935|NCT02548312|Primary|The Readers' Level of Confidence in the Conclusions Drawn in the Article.|"Measured on a single-item 10-point Likert scale from (1) not at all confident to (10) extremely confident. Higher scores indicate more confidence. Min score = 0, max score =10."|Outcome measure will be assessed only at the time of the intervention (0 weeks). Readers will be asked to complete the study questionnaire immediately after reading the review article.|One participant in the Group 'Gout review- competing interest statement 2', one in 'Dyspepsia review- competing interest statement 2', one in 'Dyspepsia- statement 3', and one in 'Gout- statement 4' did not respond to the question related to the primary outcome. Hence, for this outcome the numbers analyzed= 89, 92, 95 and 90, respectively.|||score on a scale||95% Confidence Interval|Mean
2568936|NCT02548156|Secondary|Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse|Concentration of fluoride and calcium ions in the initial expectorate, de-ionized water rinse post brushing expectorate, and 60 minutes post brushing following administration of orange juice or de-ionised water rinse|up to 60 minutes|The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.|||ppm||Standard Deviation|Mean
2568937|NCT02548156|Secondary|Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse|Concentration of fluoride and calcium ions in saliva following a rinse with either de ionised water or OJ 60 minutes after a single brushing with a fluoride dentifrice|60 minutes|The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.|||ppm||Standard Error|Least Squares Mean
2568938|NCT02548156|Secondary|Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse|Concentration of fluoride and calcium ions in saliva at baseline, 1, 5, 10, 15, 30 and 60 minutes (for calcium only) after a single brushing with a fluoride dentifrice|up to 60 minutes|The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.|||ppm||Standard Error|Mean
2568939|NCT02548156|Primary|Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse|Concentration of fluoride ions in saliva at 60 minutes after a single brushing with a fluoride dentifrice prior to rinsing with either de-ionised (DI) water or orange juice (OJ). Descriptive data is presented as least square (LS) mean and standard error (SE). SE for Fluoride is the SE of the raw mean.|60 minutes|The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.|||parts per million(ppm)||Standard Error|Least Squares Mean
2568940|NCT02548143|Secondary|"Percentages of Success as Defined as the Combination of Good and Excellent Responses by the Investigator or Designee"|Good: postoperative blood loss greater than expected following this type of procedure in a patient who does not have a bleeding disorder and who is undergoing the same surgical or other invasive procedure, not explained by a surgical/medical issue other than hemophilia; no unexpected need for blood component transfusion Excellent: postoperative blood loss similar to or less than expected following this type of procedure in a patient who does not have a bleeding disorder and who is undergoing the same surgical or other invasive procedure; no blood component transfusion is required|72 hours after procedure completion|Efficacy Population: All patients who received LR769 treatment, underwent a surgical or invasive procedure, and had at least one efficacy assessment.|||Surgeries|Surgeries||Count of Units
2568941|NCT02548143|Secondary|"Percentages of Success as Defined as the Combination of Good and Excellent Responses by the Investigator or Designee"|Good: postoperative blood loss greater than expected following this type of procedure in a patient who does not have a bleeding disorder and who is undergoing the same surgical or other invasive procedure, not explained by a surgical/medical issue other than hemophilia; no unexpected need for blood component transfusion Excellent: postoperative blood loss similar to or less than expected following this type of procedure in a patient who does not have a bleeding disorder and who is undergoing the same surgical or other invasive procedure; no blood component transfusion is required|24 hours after procedure completion|Efficacy Population: All patients who received LR769 treatment, underwent a surgical or invasive procedure, and had at least one efficacy assessment.|||Surgeries|Surgeries||Count of Units
2568942|NCT02548143|Primary|"Percentage of Surgical or Other Invasive Procedures With a Good or Excellent Response to LR769 Treatment as Assessed by the Investigator, Based on the Totality of the Assessments Performed on the Patient"|Excellent: postoperative blood loss similar to or less than expected following this type of procedure in a patient who does not have a bleeding disorder and who is undergoing the same surgical or other invasive procedure; no blood component transfusion is required Good: postoperative blood loss greater, but not substantially greater than expected, following this type of procedure in a patient who does not have a bleeding disorder and who is undergoing the same surgical or other invasive procedure, not explained by a surgical/medical issue other than hemophilia; no unexpected need for blood component transfusion|48 (±4) hours after the last administration of LR769|Efficacy Population: All patients who received LR769 treatment, underwent a surgical or invasive procedure, and had at least one efficacy assessment.|||Surgeries|Surgeries||Count of Units
2571690|NCT02513732|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|0 to 8 months|ITT population|||Participants|||Count of Participants
2568943|NCT02548078|Secondary|Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum|A seronegative subject is a subject whose titer is below the cut-off value. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value. The analysis, for this endpoint, was performed on subjects aged 1-5 years, 6-12 years and 13-17 years.|At Day 0, Day 30, Month 6 and Month 6 + 30 Days|The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.|||Percentage of participants|||Number
2568944|NCT02548078|Secondary|Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall|A seronegative subject is a subject whose titer is below the cut-off value. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value. The analysis, for this endpoint, was performed on all subjects, in both groups.|At Day 0, Day 30, Month 6 and Month 6 + 30 Days.|The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.|||Percentage of participants|||Number
2568945|NCT02548078|Secondary|Anti-GP EBOV Antibody Titers, by Age Stratum|Anti-GP EBOV antibodies were expressed as Geometric Mean Titers (GMTs), as measured by the Enzyme-Linked Immunosorbent Assay (ELISA) and assessed in subjects aged 1-5 years, 6-12 years and 13-17 years.|At Day 0, Day 30, Month 6, Month 6 + 30 Days and Month 12|The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2568946|NCT02548078|Secondary|Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall|Anti-GP EBOV antibodies were expressed as Geometric Mean Titers (GMTs), as measured by the Enzyme-Linked Immunosorbent Assay (ELISA) and assessed in all subjects, in both groups.|At Day 0, Day 30, Month 6, Month 6 + 30 Days and Month 12.|The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2568947|NCT02548078|Primary|Number of Subjects With Serious Adverse Events, by Age Stratum|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. SAEs, for this endpoint, were assessed in subjects aged 1-5 years, 6-12 years and 13-17 years.|During the entire study period: From Screening to Month 12|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2568948|NCT02548078|Primary|Number of Subjects With Serious Adverse Events, Overall|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. SAEs, for this endpoint, were assessed in all subjects, in both groups.|During the entire study period: From Screening to Month 12|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2568949|NCT02548078|Primary|Number of Subjects With Adverse Events of Specific Interest (AESI), by Age Stratum|AESI included clinical symptoms of thrombocytopenia for subjects aged 1-5 years, 6-12 years and 13-17 years.|During the 7 day follow-up period after vaccination at Day 0 (i.e. Day 0 up to Day 6)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2568950|NCT02548078|Primary|Number of Subjects With Adverse Events of Specific Interest (AESI), Overall|AESI included clinical symptoms of thrombocytopenia for all subjects, in both groups.|During the 7 day follow-up period after vaccination at Day 0 (i.e., Day 0 up to Day 6)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2568951|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Month 12|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.|||Percentage of participants|||Number
2568952|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Month 12.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.|||Percentage of participants|||Number
2568953|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Month 6 + 30 Days|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 Days time-point.|||Percentage of participants|||Number
2568954|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Month 6 + 30 Days.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 Days time-point.|||Percentage of participants|||Number
2569053|NCT02547454|Secondary|Percentage of Participants With Dose 0|Percentage of participants who did not use methoxy polyethylene glycol-epoetin beta (Dose 0) at atleast one visit during study period.|Up to 36 Months|Analysis population included all enrolled participants.|||Percentage of participants|||Number
2568957|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Month 6|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.|||Percentage of participants|||Number
2568958|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Month 6.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.|||Percentage of participants|||Number
2568959|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Day 30|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.|||Percentage of participants|||Number
2568960|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Day 30.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.|||Percentage of participants|||Number
2568961|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Day 6|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.|||Percentage of particcipants|||Number
2568962|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Day 6.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.|||Percentage of participants|||Number
2568963|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Day 3|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.|||Percentage of participants|||Number
2568964|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Day 3.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.|||Percentage of participants|||Number
2568965|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Screening|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.|||Percentage of participants|||Number
2568966|NCT02548078|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall|Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Screening.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.|||Percentage of participants|||Number
2568967|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Month 12|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.|||Percentage of participants|||Number
2568968|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, Overall|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Month 12.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.|||Percentage of participants|||Number
2568969|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Month 6 + 30 Days|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 days time-point.|||Percentage of participants|||Number
2569093|NCT02547064|Secondary|Thyromental Distance|The thyromental distance was measured.|Intraoperative anesthetic induction||||mm||Standard Deviation|Mean
2568970|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, Overall|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Month 6 + 30 Days.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 Days time-point.|||Percentage of participants|||Number
2568971|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Month 6 + 6 Days|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 days time-point.|||Percentage of participants|||Number
2568972|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, Overall|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Month 6 + 6 Days.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 Days time-point.|||Percentage of participants|||Number
2568973|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Month 6|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.|||Percentage of participants|||Number
2568974|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, Overall|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Month 6.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.|||Percentage of participants|||Number
2568975|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Day 30|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.|||Percentage of participants|||Number
2568976|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, Overall|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Day 30.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.|||Percentage of participants|||Number
2568977|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Day 6|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.|||Percentage of participants|||Number
2568978|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, Overall|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Day 6.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.|||Percentage of participants|||Number
2568979|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Day 3|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.|||Percentage of participants|||Number
2568980|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, Overall|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Day 3.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.|||Percentage of participants|||Number
2569094|NCT02547064|Secondary|Mallampati Grade|The Mallapati grade was assessed as I/II/III/IV (I: Soft palate, uvula, fauces, pillars visible, II: Soft palate, uvula, fauces visible, III: Soft palate, base of uvula visible, IV: Only hard palate visible). Grade I was considered better outcomes.|Intraoperative anesthetic induction||||Participants|||Count of Participants
2568981|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.|At Screening|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.|||Percentage of participants|||Number
2568982|NCT02548078|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities, Overall|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.|At Screening.|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.|||Percentage of participants|||Number
2568983|NCT02548078|Primary|Number of Subjects With Unsolicited Adverse Events (AEs), by Age Stratum|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Unsolicited AEs, for this endpoint, were assessed in subjects between 1-5 years of age, 6-12 years of age and 13-17 years of age.|During the 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2568984|NCT02548078|Primary|Number of Subjects With Unsolicited Adverse Events (AEs), Overall|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Unsolicited adverse events, for this endpoint, were assessed in all subjects, in both groups.|During the 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2568985|NCT02548078|Primary|Number of Subjects With Solicited General Symptoms, by Age Stratum|Solicited general symptoms assessed included: fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache, drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 fatigue/headache/drowsiness/gastrointestinal symptoms = fatigue/headache/drowsiness/gastrointestinal symptoms that prevented normal activity. Grade 3 fever = temperature > 39.5°C. Grade 3 irritability/fussiness = crying that couldn't be comforted. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination. Solicited general symptoms, for this endpoint, were assessed in subjects aged 1-5 years, 6-12 years and 13-17 years. Symptoms with no values were not assessed for those specific age groups.|During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
2568986|NCT02548078|Primary|Number of Subjects With Solicited General Symptoms, Overall|Solicited general symptoms assessed included: fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache, drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 fatigue/headache/drowsiness/gastrointestinal symptoms = fatigue/headache/drowsiness/gastrointestinal symptoms that prevented normal activity. Grade 3 fever = temperature > 39.5°C. Grade 3 irritability/fussiness = crying that couldn't be comforted. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination. Solicited general symptoms, for this endpoint, were assessed in all subjects, in both groups.|During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
2568987|NCT02548078|Primary|Number of Subjects With Solicited Local Symptoms, by Age Stratum|Assessed solicited local symptoms included: pain and swelling at the injections site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying at limb movement/spontaneous pain.Grade 3 swelling = swelling extending on a surface higher than (>) 30 millimeters (mm), for children between 1-5 years old; > 50 mm for children between 6-12 years old and >100 mm for children between 13-17 years old.|During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
2568988|NCT02548078|Primary|Number of Subjects With Solicited Local Symptoms, Overall|Assessed solicited local symptoms included: pain and swelling at the injections site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying at limb movement/spontaneous pain.Grade 3 swelling = swelling extending on a surface higher than (>) 30 millimeters (mm). Solicited local symptoms, for this endpoint, were assessed in all subjects, in both groups.|During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.|||Participants|||Count of Participants
2568990|NCT02547974|Secondary|Frequency of Specific CD8+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response|Frequency of specific CD8+ T-cells are measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers (such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L). The frequency of specific CD8+ T-cells are summarised [descriptive statistics: Mean and standard deviation (SD)] against each antigen (PD, PE, PilA and UspA2), by group in Step 2 at each time point during which blood samples are collected for CMI.|At Day 0 (pre-dose 1); at Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||CD8+ T-cells/million cells||Standard Deviation|Mean
2568991|NCT02547974|Secondary|Frequency of Specific Cluster of Differentiation (CD)4+ T-cells Against NTHi-Mcat Antigens Collected for the Evaluation of Cell-mediated Immune Response|Frequency of specific CD4+ T-cells are measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers (such as Interleukin [IL]-2, IL-13, IL-17, Interferon gamma [FN-γ], Tumour necrosis factor alpha [TNF-α] and CD40L). The frequency of specific CD4+ T-cells are summarised [descriptive statistics: Mean and standard deviation (SD)] against each antigen (PD, PE, PilA and UspA2), by group in Step 2 at each time point during which blood samples are collected for CMI.|At Day 0 (pre-dose 1); at Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||CD4+ T-cells/million cells||Standard Deviation|Mean
2568992|NCT02547974|Secondary|Concentration of Antibodies Against the NTHi-Mcat Anti-UspA2 (Ubiquitous Surface Protein A2 of Moraxella Catarrhalis) Vaccine Component|Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 38 EL.U/mL for anti-UspA2 antibodies.|At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2568993|NCT02547974|Secondary|Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component|Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 16 EL.U/mL for anti-PilA antibodies.|At Day 210 and Day 420 (post-dose2).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2568994|NCT02547974|Secondary|Concentration of Antibodies Against the NTHi-Mcat Anti-PilA (Type IV Pili Subunit of Non-typeable Haemophilus Influenzae) Vaccine Component|Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 7 EL.U/mL for anti-PilA antibodies.|At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90 (post-dose2).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2568995|NCT02547974|Secondary|Concentration of Antibodies Against the NTHi-Mcat Anti-PE (Protein E of Haemophilus Influenzae) Vaccine Component|Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 25 EL.U/mL for anti-PE antibodies.|At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2568996|NCT02547974|Secondary|Concentration of Antibodies Against the NTHi-Mcat Anti-PD (Protein D of Haemophilus Influenzae) Vaccine Component|Antibody concentrations are measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay is 153 EL.U/mL for anti-PD antibodies.|At Day 0 (pre-dose 1); at Day 30 and Day 60 (post-dose 1); at Day 90, Day 210 and Day 420 (post-dose2).|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2568997|NCT02547974|Primary|Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From first vaccination up to study conclusion (Day 0 to Day 420)|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2568998|NCT02547974|Primary|Number of Subjects With Any Serious Adverse Events (SAEs)|Assessed SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination up to study conclusion (Day 0 to Day 420)|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2568999|NCT02547974|Primary|Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination|"Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point.~Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point."|At Day 420, post-dose 2.|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2569000|NCT02547974|Primary|Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination|"Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point.~Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point."|At Day 210, post-dose 2.|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2569001|NCT02547974|Primary|Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination|"Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point.~Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point."|At Day 67, post-dose 2.|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2569002|NCT02547974|Primary|Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities After Vaccination|"Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point.~Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point."|At Day 60, post-dose 1.|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2569003|NCT02547974|Primary|Number of Subjects With Any Haematological and Biochemical Laboratory Abnormalities, After Vaccination.|"Assessed haematological parameters are complete blood cell count: Erythrocytes (RBC [red blood cells]), Leukocytes (WBC [white blood cells]), differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point.~Assessed biochemical parameters are alanine aminotransferase [ALT], aspartate aminotransferase [AST] or creatinine below or above the normal laboratory ranges tabulated by time point."|At Day 7, post-dose 1.|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2569004|NCT02547974|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|Assessed unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During a 30-day follow-up period (Day 60 to Day 89) after second dose|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2569005|NCT02547974|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|Assessed unsolicited AEs cover any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During a 30-day follow-up period (Day 0 to Day 29) after first dose.|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2569006|NCT02547974|Primary|Number of Subjects With Any Solicited General Adverse Events (AEs)|Assessed solicited general symptoms are fatigue, gastrointestinal symptoms, headache, myalgia, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)].|During a 7-day follow-up period (Day 60 to Day 66) after second dose.|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2569007|NCT02547974|Primary|Number of Subjects With Any Solicited General Adverse Events (AEs)|Assessed solicited general symptoms are fatigue, gastrointestinal symptoms, headache, myalgia, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)].|During a 7-day follow-up period (Day 0 to Day 6) after first dose.|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2569008|NCT02547974|Primary|Number of Subjects With Any Solicited Local Adverse Events (AEs)|Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (Day 60 to Day 66) after second dose|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2569659|NCT02539368|Primary|Reasons for Switching Treatment by Participants||From baseline to follow-up period (up to a maximum duration of 2 years)|Reasons for switch were not captured in electronic data capture. Hence, due to change in planned analysis, data was not collected and analyzed.||||||
2569009|NCT02547974|Primary|Number of Subjects With Any Solicited Local Adverse Events (AEs)|Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (Day 0 to Day 6) after first dose.|Analysis was performed on the total vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2569010|NCT02547935|Secondary|Adjusted Mean Change From Baseline in HbA1c: Comparison of Dapagliflozin 10 mg and Placebo at Week 24|HbA1c was analysed at baseline and every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a MMRM model.|Baseline and Week 24|Patients from the Full Analysis Set with non-missing baseline and Week 24 values for HbA1c.|||Percentage of Glycoslyated HbA1c||Standard Error|Least Squares Mean
2569011|NCT02547935|Secondary|Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24|Seated SBP was analysed at baseline, Week 1 and every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a MMRM model.|Baseline and Week 24|Patients from the Full Analysis Set with non-missing baseline and Week 24 values for SBP.|||Millimetre of mercury (mmHg)||Standard Error|Least Squares Mean
2569012|NCT02547935|Secondary|Percentage of Patients Achieving a Reduction in HbA1c of Less Than 7.0% at Week 24|The percentage of patients meeting the criteria of a less than 7% reduction in HbA1c, was analysed using a logistic regression model. If no measurement was available at Week 24 the last available post-baseline measurement was carried forward (LOCF). Only measurements prior to rescue or treatment discontinuation were analysed.|From baseline to Week 24|Patients from the Full Analysis Set with non-missing baseline and at least one post-baseline HbA1c value.|||Percentage of patients|||Number
2569013|NCT02547935|Secondary|Percentage of Patients Achieving at Least 30% Reduction in UACR at Week 24|The percentage of patients meeting the criteria of at least a 30% reduction in UACR, was analysed using a logistic regression model. If no measurement was available at Week 24 the last available post-baseline measurement was carried forward (Last Observation Carried Forward [LOCF]).|From baseline up to Week 24|Patients from the Full Analysis Set with non-missing baseline and at least one post-baseline UACR value.|||Percentage of patients|||Number
2569014|NCT02547935|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|FPG was analysed at baseline and Week 1 then every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a MMRM model.|Baseline and Week 24|Patients from the Full Analysis Set with non-missing baseline and Week 24 values for FPG.|||mg/decilitre (dL)||Standard Error|Least Squares Mean
2569015|NCT02547935|Secondary|Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24|Total body weight was measured in kilograms (kg) at baseline and at Week 1 then every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. Total body weight values were first transformed to logarithms and the results were based on exponentiation of model estimates and expressed as adjusted mean percent change from baseline at Week 24.|Baseline and Week 24|Patients from the Full Analysis Set with non-missing baseline and Week 24 values for total body weight.|||Percent change||Standard Error|Least Squares Mean
2569016|NCT02547935|Primary|Adjusted Mean Percent Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Week 24|UACR was analysed at baseline and every 4 weeks during the 24-week treatment period. All measurements regardless of rescue medication or treatment discontinuation were analysed. UACR values were first transformed to logarithms and the results were based on exponentiation of model estimates and expressed as adjusted mean percent change from baseline at Week 24.|Baseline and Week 24|Patients from the Full Analysis Set with non-missing baseline and Week 24 values for UACR.|||Percent change||Standard Error|Least Squares Mean
2569017|NCT02547935|Primary|Adjusted Mean Change From Baseline in Glycosylated Haemoglobin (HbA1c): Comparison of Dapagliflozin 10 mg Plus Saxagliptin 2.5 mg and Placebo at Week 24|HbA1c was analysed at baseline and every 4 weeks during the 24-week treatment period. Only measurements prior to rescue or treatment discontinuation were analysed. The adjusted mean change from baseline at Week 24 was analysed using a mixed model repeated measures (MMRM) model.|Baseline and Week 24|Patients from the Full Analysis Set (all randomised patients who took at least 1 dose of double-blind study drug and had a non missing baseline value and at least one post-baseline efficacy variable value) with non-missing baseline and Week 24 values for HbA1c.|||Percentage of Glycoslyated HbA1c||Standard Error|Least Squares Mean
2569018|NCT02547779|Secondary|30-day In-hospital Mortality|Death before hospital discharge, censored at 30 days after enrollment|30 days after enrollment censored at hospital discharge||||Participants|||Count of Participants
2569019|NCT02547779|Primary|Major Adverse Kidney Event Within 30 Days|The primary outcome was the proportion of patients who met one or more criteria for a major adverse kidney event within 30 days — the composite of death, new receipt of renal-replacement therapy, or persistent renal dysfunction (defined as a final inpatient creatinine value ≥200% of the baseline value) — all censored at hospital discharge or 30 days after enrollment, whichever came first.|30 days after enrollment censored at hospital discharge|Of 15,802 patients in the SMART trial, 7,860 were assigned to saline and 7,942 were assigned to balanced crystalloids, of whom 10,421 were enrolled to surgical ICUs with 5,214 assigned to saline and 5,207 assigned to balanced crystalloids.|||Participants|||Count of Participants
2569020|NCT02547766|Secondary|Biologic Efficacy: Inflammation Marker - TNFalpha|Secondary endpoints included the measure of additional inflammatory markers, including TNFalpha.|6 months post treatment|Patients|||pg/mL||Full Range|Median
2569021|NCT02547766|Secondary|Clinical Efficacy: Ejection Fraction|Clinical efficacy was a secondary endpoint that was measured using ejection fraction (EF)|6 months post treatment|Patients|||percentage of blood leaving heart||Full Range|Median
2569022|NCT02547766|Secondary|Biologic Efficacy: Inflammation Marker - Neutrophil Count|Secondary endpoints included the measure of additional inflammatory markers, including neutrophil count.|6 months post treatment|Patients|||10^3 cells/µL||Full Range|Median
2569023|NCT02547766|Primary|Biologic Efficacy: Inflammation Marker - C-Reactive Protein|The primary endpoint was a reduction in inflammatory markers, specifically C-reactive protein (CRP).|6 months post treatment|Patients|||mg/dL||Full Range|Median
2569024|NCT02547714|Secondary|Percentage of Participants Achieving DLQI 0 or 1|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment."|Week 16|The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.|||Percentage of participants|||Number
2569025|NCT02547714|Secondary|Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Week 16|The full analysis set was considered for the analysis. Only participants who had both baseline and week 16 values were included in the analysis. The full analysis set included all participants who received at least one dose of study drug.|||Percent change||Standard Deviation|Mean
2569026|NCT02547714|Secondary|Percentage of Participants Achieving PASI 90 and Investigator's Global Assessment (IGA) of 0 or 1 Response|"PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).~PASI 90 was defined as participants achieving >= 90% improvement from baseline. The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of assessment and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe."|Week 16|The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.|||Percentage of participants|||Number
2569027|NCT02547714|Secondary|Percentage of Participants Achieving PASI 50 or PASI 75|"PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).~PASI 50 and PASI 75 were defined as participants achieving >= 50% or >= 75% improvement from baseline, respectively."|Week 4|The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.|||Percentage of participants|||Number
2569028|NCT02547714|Secondary|Mean Percent Change From Baseline in PASI Score|PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). A negative change from baseline indicates improvement.|Week 4|The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.|||Percent change||Standard Deviation|Mean
2569029|NCT02547714|Primary|Percentage of Participants Who Achieved ≥ 75% Psoriasis Area and Severity Index (PASI 75)|PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 75 was defined as participants achieving >= 75% improvement from baseline.|Week 16|The full analysis set, which included all participants who received at least one dose of study drug, was analyzed.|||Percentage of participants|||Number
2569030|NCT02547649|Secondary|Percentage of Participants With a ≥4-fold Rise From Baseline in Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) Antibodies|The percentage of participants with ≥4-fold rise from baseline in IgG GMCs of each common serotype (CS) and V114-specific serotype (VS) were compared in the V114 and Prevnar® 13 arms. Estimated GMT, GMT ratio, 95% CI, and p-values were obtained from a constrained longitudinal data analysis (cLDA) model.|Baseline and Day 30 (one month after vaccination)|All vaccinated participants with data available are included.|||Percentage of Participants||95% Confidence Interval|Number
2569031|NCT02547649|Secondary|Percentage of Participants With a ≥4-fold Rise From Baseline in Serotype-specific Opsonophagocytic Killing Activity (OPA) Geometric Mean Titers (GMTs)|The percentage of participants with ≥4-fold rise from baseline in OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were compared in the V114 and Prevnar® 13 arms. Estimated GMT, GMT ratio, 95% CI, and p-values were obtained from a constrained longitudinal data analysis (cLDA) model.|Baseline and Day 30 (one month after vaccination)|All vaccinated participants with data available are included.|||Percentage of Participants||95% Confidence Interval|Number
2570386|NCT02530970|Primary|Proportion of Subjects With ECM Related Adverse Events|ECM related adverse events were collected at all study visits.|Participants were followed for an average of 235.0 days.|Analysis population includes all study participants.|||Participants|||Count of Participants
2569032|NCT02547649|Secondary|Geometric Mean Concentrations (GMCs) of Serotype-specific Immunoglobulin G (IgG) at One Month Post-Vaccination|The IgG GMCs of each common pneumococcal serotype (CS) and V114-specific pneumococcal serotype (VS) were determined for each arm. Concentrations were determined with pneumococcal electrochemiluminescence (PnECL).|Day 30 (one month after vaccination)|All vaccinated participants with data available are included.|||µg/mL||95% Confidence Interval|Geometric Mean
2569033|NCT02547649|Primary|Geometric Mean Titers (GMTs) of Serotype-specific Opsonophagocytic Killing Activity (OPA) at One Month Post-Vaccination|The OPA GMTs of each common serotype (CS) and V114-specific serotype (VS) were determined in each arm. Titer levels were determined with the multiplexed opsonophagocytic assay (MOPA).|Day 30 (one month after vaccination)|All vaccinated participants with data available are included.|||Titers||95% Confidence Interval|Geometric Mean
2569034|NCT02547649|Primary|Percentage of Participants With Vaccine-Related Serious Adverse Event (SAE)|The percentage of participants experiencing ≥1 vaccine-related SAEs(s) in each arm was determined.|Up to 30 days after vaccination|All participants who received study vaccination are included.|||Percentage of Participants|||Number
2569035|NCT02547649|Primary|Percentage of Participants With a Serious Adverse Event (SAE)|The percentage of participants experiencing ≥1 SAE(s) in each arm was determined.|Up to 30 days after vaccination|All participants who received study vaccination are included.|||Percentage of Participants|||Number
2569036|NCT02547649|Primary|Percentage of Participants With a Solicited Systemic Adverse Event (AE)|The percentage of participants experiencing ≥1 solicited systemic AE(s) in each arm was determined.|Up to 14 days after vaccination|All participants who received study vaccination are included.|||Percentage of Participants|||Number
2569037|NCT02547649|Primary|Percentage of Participants With a Solicited Injection-site Adverse Event (AE)|The percentage of participants experiencing ≥1 solicited injection-site AE(s) in each arm was determined.|Up to 14 days after vaccination|All participants who received study vaccination are included.|||Percentage of Participants|||Number
2569038|NCT02547649|Primary|Percentage of Participants With an Adverse Event (AE)|The percentage of participants experiencing ≥1 AE(s) in each arm was determined. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 days after vaccination|All participants who received study vaccination are included.|||Percentage of Participants|||Number
2569039|NCT02547623|Secondary|Dilated Opthalmoscopy Findings - Vitreous (Study Eye)|The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's vitreous|Baseline, POD 90/Early termination||||Participants|||Count of Participants
2569040|NCT02547623|Secondary|Dilated Opthalmoscopy Findings - Choroid (Study Eye)|The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's choroid|Baseline, POD 90/Early termination||||Participants|||Count of Participants
2569041|NCT02547623|Secondary|Dilated Opthalmoscopy Findings - Macula (Study Eye)|The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's macula.|Baseline, POD 90/Early termination||||Participants|||Count of Participants
2569042|NCT02547623|Secondary|Dilated Opthalmoscopy Findings - Retina (Study Eye)|The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's retina|Baseline, POD 90/Early termination||||Participants|||Count of Participants
2569043|NCT02547623|Secondary|Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)|The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's optic disc|Baseline, POD 90/Early termination||||Participants|||Count of Participants
2569044|NCT02547623|Secondary|Optic Disc Cup-disc Ratio for the Study Eye|Calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc).|Baseline, POD 90/Early termination||||ratio||Standard Deviation|Mean
2569045|NCT02547623|Secondary|Changes in the Corneal Endothelial Cell Count|Corneal Endothelial Cell Density was measured by specular microscopy.|Baseline, Postoperative day 90/Early termination||||cells/mm^2||Standard Deviation|Mean
2569046|NCT02547623|Secondary|Summary of Concomitant Medications Used in the Study Eye or Both Eyes||Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination||||Participants|||Count of Participants
2569047|NCT02547623|Secondary|Slit Lamp Biomicroscopy - Cornea Edema Grade|"Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator's standard slit lamp equipment and procedure.~Cornea edema slit lamp results in the study eye were summarized by treatment group and time point."|Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination||||Participants|||Count of Participants
2569048|NCT02547623|Secondary|Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade|"Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator's standard slit lamp equipment and procedure.~Conjunctiva hyperemia slit lamp results were summarized by treatment group and time point."|Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination||||Participants|||Count of Participants
2569049|NCT02547623|Secondary|Visual Acuity in Study Eye|Visual Acuity assessed by the Snellen chart, was expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1|Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination||||LogMar||Standard Deviation|Mean
2569050|NCT02547623|Secondary|Intraocular Pressure Measurement|Intraocular Pressure was measured by Goldmann applanation tonometry.|Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination||||mmHG||Standard Deviation|Mean
2569051|NCT02547623|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|Treatment-emergent Adverse Events were defined as events that started after the study drug administration, and occurred before termination of the study, or were present before study drug administration and worsened after dose administration.|Baseline to postoperative day 90/ early termination||||Participants|||Count of Participants
2569052|NCT02547454|Secondary|Percentage of Participants With Iron Replacement|Iron replacement was given to the participants either in oral iron replacement or intravenous replacement or both.|Up to 36 Months|Analysis population included all enrolled participants.|||Percentage of participants|||Number
2569054|NCT02547454|Secondary|Number of Dose Adaptations|Total number of changes (increase or decrease) in daily methoxy polyethylene glycol-epoetin beta doses. The reasons for dose-adaptations included: inflammation or infection; kidney function decline; over-response; iron deficiency; insufficient response; adverse effect; start of maintenance dose; kidney function improvement; re-introduction of treatment; and others (other reasons than specified).|Up to 36 Months|Analysis population included all enrolled participants.|||Events|||Number
2569055|NCT02547454|Secondary|Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta|Median monthly dose of methoxy polyethylene glycol-epoetin beta administered in the study up to 36 months.|Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and After 21 Months up to 36 Months|Analysis population included all enrolled participants. Here, n signifies participants with available data at specified time-point.|||microgram||Full Range|Median
2569056|NCT02547454|Secondary|Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta|Average dose of methoxy polyethylene glycol-epoetin beta administered at Baseline|Baseline|Analysis population included all enrolled participants.|||microgram||Standard Deviation|Mean
2569057|NCT02547454|Secondary|Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L||Up to 36 Months|Analysis population included all enrolled participants.|||Months||Full Range|Median
2569058|NCT02547454|Secondary|Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L||Up to 36 Months|Analysis population included all enrolled participants.|||Months||Full Range|Median
2569059|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|After 21 Months up to 36 Months|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
2569060|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 19-21|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
2569061|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 16-18|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
2569062|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 13-15|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
2569063|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 10-12|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
2569064|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 7-9|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
2569065|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 4-6|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
2569066|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 1-3|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
2569067|NCT02547454|Primary|Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Baseline|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
2569068|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|After 21 Months up to 36 Months|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
2569069|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 19-21|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
2569070|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 16-18|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
2569071|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 13-15|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
2569072|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 10-12|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
2569073|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 7-9|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
2569074|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 4-6|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
2569075|NCT02547454|Primary|Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|At Months 1-3|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
2569076|NCT02547454|Primary|Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline|If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.|Baseline|Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.|||Percentage of participants|||Number
2569077|NCT02547363|Secondary|Percent Reduction in AK Count in the Treatment Area Compared to Baseline|The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable. The table presents adjusted mean percent reduction at Week 8 from baseline.|At Week 8||||percentage of reduction||95% Confidence Interval|Mean
2569078|NCT02547363|Secondary|Percentage of Participants With Partial Clearance of AKs|Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.|At Week 4||||percentage of participants||95% Confidence Interval|Number
2569079|NCT02547363|Secondary|Percentage of Participants With Partial Clearance of AKs|Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.|At Week 8||||percentage of participants||95% Confidence Interval|Number
2569080|NCT02547363|Primary|Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)|"The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1 (baseline), Week 4 and Week 8.~Complete clearance was defined as no clinically visible AKs in the treatment area."|At Week 8||||percentage of participants||95% Confidence Interval|Number
2569081|NCT02547233|Secondary|Percent Reduction in AK Count in the Treatment Area Compared to Baseline|The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable (using multiple imputations to account for missing values). The table presents adjusted mean percent reduction at Week 8 from baseline.|At Week 8||||percentage of reduction||95% Confidence Interval|Mean
2569082|NCT02547233|Secondary|Percentage of Participants With Partial Clearance (Multiple Imputation)|"Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.~The table shows the percentage of mean number of participants across imputations with partial clearance."|At Week 4||||percentage of participants||95% Confidence Interval|Number
2569083|NCT02547233|Secondary|Percentage of Participants With Partial Clearance (Multiple Imputation)|"Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.~The table shows the percentage of mean number of participants across imputations with partial clearance."|At Week 8||||percentage of participants||95% Confidence Interval|Number
2569084|NCT02547233|Primary|Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)|"Complete clearance was defined as an AK count of zero, i.e. no clinically visible AKs (actinic keratosis lesions) in the treatment area.~The table shows the percentage of mean number of subjects across imputations with complete clearance."|At Week 8||||percentage of participants||95% Confidence Interval|Number
2569085|NCT02547129|Secondary|Post-operative Range of Motion (ROM)|The degree of knee flexion was measured one year post-operatively.|1 year post-operatively|Study was terminated early due to difficulty enrolling patients.||||||
2569086|NCT02547129|Secondary|Pre-operative Range of Motion (ROM)|The degree of knee flexion was measured pre-operatively.|baseline|Study was terminated early due to difficulty enrolling patients.||||||
2569087|NCT02547129|Primary|Change in Total Knee Replacement Functional Scores|Functional scores were measured using the Knee Society Score, a clinical standard for rating the outcome of total knee replacements. Scores range from 0 -100, where a higher score reflects a more positive outcome for the subject.|baseline, 1 year post-operatively|Study was terminated early due to difficulty enrolling patients.||||||
2569088|NCT02547129|Primary|Number of Subjects With Repeat Infections|The rate of repeat infections after re-implantation Total Knee Arthroplasty.|1 year post-operatively|Study was terminated early due to difficulty enrolling patients.||||||
2569089|NCT02547064|Secondary|Airway Injury|Larynx injury is assessed.|Intraoperative intubation||||Participants|||Count of Participants
2569090|NCT02547064|Secondary|Heart Rate|Heart rates are measured before and 2 min after intubation.|Intraoperative intubation||||beats per minute||Standard Deviation|Mean
2569091|NCT02547064|Secondary|Mean Blood Pressure|Mean blood pressure is measured before and 2 min after intubation.|Intraoperative intubation||||mmHg||Standard Deviation|Mean
2569092|NCT02547064|Secondary|Postoperative Sore Throat Measured Using Visual Analogue Scale|Postoperative sore throat will be measured using visual analogue scale (0:no pain, 100: worst pain imaginable)|at 1, 24 hr postoperatively||||units on a scale||Standard Deviation|Mean
2569095|NCT02547064|Secondary|Cormack-Lehan Grade|The grade of Cormack-Lehan was assessed as I/II/III/IV (I: Full view of glottis, II: Partial view of glottis, III: Only epiglottis seen, none of glottis seen, IV: Neither glottis nor epiglottis seen). Grade I was considered better outcomes.|Intraoperative intubation||||Participants|||Count of Participants
2569096|NCT02547064|Secondary|Number of Participants for Whom External Laryngeal Manipulation Was Necessary|External laryngeal manipulation is defined as the compression of neck for the facilitation of laryngeal view. Number of participants for whom external laryngeal manipulation was necessary will be measured.|Intraoperative intubation||||Participants|||Count of Participants
2569097|NCT02547064|Secondary|Difficulty of Intubation Measured Using Visual Analogue Scale|Difficulty of intubation will be measured using visual analogue scale (0:easiest, 100:most difficult).|Intraoperative intubation||||units on a scale||Standard Deviation|Mean
2569098|NCT02547064|Secondary|Success Rate of Intubation|The number of patients in which the intubation was successful at the first time.|Intraoperative intubation||||Participants|||Count of Participants
2569099|NCT02547064|Primary|Time to Intubation|Time from the insertion of the Glidescope blade to the measurement of end tidal CO2 (>30 mmHg)|Intraoperative intubation||||sec||Standard Deviation|Mean
2569100|NCT02547038|Primary|Number of Participants in Which H. Pylori Was Eradicated|Evaluate eradication outcome by endoscopy urease test and histology or urea breath test (Number of Participants With Complete Eradication of Helicobacter Pylori)|sixth week after the end of anti- H. pylori therapy|Intention to treat|||participants|||Number
2569101|NCT02547012|Primary|Number of Participants in Which H. Pylori Was Eradicated|Evaluate eradication outcome by endoscopy urease test and histology or urea breath test|six weeks after the end of anti-H pylori therapy.|Intention to treat|||participants|||Number
2569102|NCT02546986|Secondary|Apparent Volume of Distribution (Vd/F) of CC-486|Apparent volume of distribution, was calculated according to the equation: Vd/F = (CL/F)/λz|PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1|The PK population includes participants with evaluable CC-486 plasma PK profile.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2569103|NCT02546986|Secondary|Apparent Total Plasma Clearance (CL/F) of CC-486|Apparent total plasma clearance (CL/F) of CC-486 was calculated as Dose/AUC∞|PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1|The PK population includes participants with evaluable CC-486 plasma PK profile.|||Liters/hour||Geometric Coefficient of Variation|Geometric Mean
2569104|NCT02546986|Secondary|Terminal Phase of Half-life (T1/2) of CC-486|Terminal phase half-life in plasma, calculated as [(ln 2)/λz]. t1/2 was only be calculated when a reliable estimate for λz could be obtained.|PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1|The PK population includes participants with evaluable CC-486 plasma PK profile.|||hours||Geometric Coefficient of Variation|Geometric Mean
2569105|NCT02546986|Secondary|Time to Maximum Plasma Concentration (Tmax) of CC-486|Time to maximum observed plasma concentration obtained directly from the observed concentration versus time data.|PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1|The PK population includes participants with evaluable CC-486 plasma PK profile.|||hours||Full Range|Median
2569106|NCT02546986|Secondary|Maximum Observed Plasma Concentration (Cmax) of CC-486|Maximum observed plasma concentration, obtained directly from the observed concentration versus time data.|PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1|The PK population includes participants with evaluable CC-486 plasma PK profile.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2569107|NCT02546986|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of CC-486|Area under the plasma concentration-time curve from Time 0 to the time of the last quantifiable concentration, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|PK blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1|The PK population includes participants with evaluable CC-486 plasma PK profile.|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
2569108|NCT02546986|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of CC-486|Area under the plasma concentration-time curve from Time 0 extrapolated to infinity, calculated as [AUCt + Ct/ λz]. Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz. If AUC % extrap is ≥25%, AUCi inf was not reported.|Pharmacokinetic (PK) blood samples collected at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6 and 8 hours after CC-486 administration on Cycle 1 Day 1 and Cycle 2 Day 1|The PK population includes participants with evaluable CC-486 plasma PK profile.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2569109|NCT02546986|Primary|Kaplan Meier Estimate of Progression-Free Survival (PFS) Based on European Medicines Agency Methodology|Progression-free survival was defined according to EMA methodology as the time from the date of randomization to the date of disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (documented by computed tomography scan result, not including symptomatic deterioration) or death for (any cause) on or prior to the data cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the last known time that the participant was progression free. However, occasional missing observations or initiation of subsequent new anticancer therapy would not result in censoring for this analysis. Progressive disease is at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion.|From Day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 12 April 2017; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the PBZ + Placebo arm|The Intent-to-Treat population includes all participants who were randomized, regardless of whether they received assigned treatment or not.|||months||90% Confidence Interval|Median
2569132|NCT02546609|Secondary|Change in Circulating Cytokeratin 18 Fragments (M30)|Change in Circulating Cytokeratin 18 Fragments (M30) from Baseline to Week 16 will be examined through standard blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the mean change (SD) in circulating cytokeratin 18 fragments (M30, U/L) from Baseline to week 16 was assessed|||U/L||Standard Deviation|Mean
2569110|NCT02546986|Secondary|Number of Participants With Treatment Emergent Adverse Events|Treatment-emergent adverse events (TEAEs) were defined as any adverse event (AE) or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the investigational product (IP) through 28 days after the last dose of IP. In addition, any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and based on the following scale: Grade 1 = Mild; Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.|From date of first dose of study treatment until 30 days after the last dose of IP; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the PBZ + Placebo arm|The safety population includes all participants who were randomized and received at least one dose of study drug.|||Participants|||Count of Participants
2569111|NCT02546986|Secondary|Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response|"The best overall response is defined as the percentage of participants who achieved an objective confirmed complete response or partial response according to RECIST v1.1, compared with baseline where baseline was the last computed tomography (CT) scan obtained prior to or on day 1 of study treatment.~RECIST v1.1 is defined as:~Complete response: disappearance of all target lesions~Partial response: at least a 30% decrease in the sum of diameters of target lesions from baseline~Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease~Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion."|Response was assessed every 6 weeks for the first 24 weeks, then every 9 weeks until DP, new anticancer initiation, or withdrawal of consent; maximum treatment exposure for CC-486 + PBZ was 61 weeks and 60 weeks for PBZ + PBO|The Intent-to-Treat population includes all participants who were randomized.|||Percentage of Participants||90% Confidence Interval|Number
2569112|NCT02546986|Secondary|Kaplan Meier Estimate of Overall Survival|Overall survival (OS) was defined as the time in months between day 1 of treatment and death from any cause. Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.|From Day 1 of treatment up to the clinical cut-off date of 12 April 2017, whichever occurred earlier; median follow-up time for OS was 11.3 months in the CC-486 + PBZ arm and 12.2 months in the PBZ + Placebo arm|The Intent-to-Treat population includes all participants who were randomized.|||months||90% Confidence Interval|Median
2569113|NCT02546986|Secondary|Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for a Minimum Duration of 18 Weeks Compared to Baseline|"Disease control rate was defined as the percentage of participants who had confirmed stable disease, complete or partial response during the course of study, according to RECIST v1.1, as evaluated by the investigator.~RECIST v 1.1 is defined as:~Complete response: disappearance of all target lesions~Partial response: at least a 30% decrease in the sum of diameters of target lesions from baseline~Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease~Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion. When stable disease was believed to be the best response, it must have met the minimum duration of 10 weeks from randomization."|Response was assessed every 6 weeks for the first 24 weeks, then every 9 weeks until DP, new anticancer initiation, or withdrawal of consent; maximum treatment exposure for CC-486 + PBZ was 61 weeks and 60 weeks for PBO +PBZ|The Intent-to-Treat population includes all participants who were randomized, regardless of whether they received assigned treatment or not.|||Percentage of Participants||90% Confidence Interval|Number
2569114|NCT02546986|Primary|Kaplan Meier Estimate of Progression-Free Survival (PFS) Based on Food and Drug Administration (FDA) Methodology|PFS was defined according to the FDA Methodology as the time in months from the date of randomization to the date of disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (documented by computed tomography scan, not including symptomatic deterioration) or death for (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Those who did not have disease progression or had not died as of the data cutoff date were censored at the time of the last radiologic assessment where the participant was documented to be progression-free prior to the data cutoff date. Progressive disease includes at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion.|From Day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 12 April 2017; overall maximum treatment duration was 61 weeks for the CC-486 + PBZ arm and 60 weeks for the PBZ + Placebo arm|The Intent-to-Treat population includes all participants who were randomized, regardless of whether they received assigned treatment or not.|||months||90% Confidence Interval|Median
2569115|NCT02546765|Secondary|Follow up Incidence of Cognitive Dysfunction|The follow up incidence of cognitive dysfunction will be analyzed at 1 month after discharge. T-MoCA is Telephone Montreal Cognitive Assessment Scale (MOCA). The T-MoCA is scored out of 22. The minimum score is 0 (worst) and maximum score is 22 (best). T-MOCA is converted back to 30 (full MOCA) with the help of conversion algorithms to a full MOCA.Example: 19/22 converts back to 30 by performing the following equation: (19×30) ÷ 22. The total converted score is 25.9 or 26/30 which is considered in the normal range.|Patients will be assessed for cognitive dysfunction with T-MOCA at 1 month following the date of surgery|Telephone (T)-MOCA at 1 month. This is a 2 x 2 cross over study.|||units on a scale||Inter-Quartile Range|Median
2569116|NCT02546765|Secondary|ICU Length of Stay|Defined by the number of days admitted in the ICU prior to transfer to the general cardiac surgical floor|Measured in days admitted in the ICU, an average of 2 days|This is a 2 x 2 cross over study.|||hours||Inter-Quartile Range|Median
2569117|NCT02546765|Secondary|Hospital Length of Stay|Defined by the number of days admitted in the hospital following the completion of surgery.|Measured in days admitted in the hospital, an average of 6 days|This is a 2 x 2 cross over study.|||days||Inter-Quartile Range|Median
2569133|NCT02546609|Secondary|Change in Serum AlanineAaminotransferase (ALT) Levels|Serum AlanineAminotransferase (ALT) will be examined through standard blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the mean change (SD) in serum ALT levels from Baseline to Week 16 was assessed|||U/L||Standard Deviation|Mean
2569118|NCT02546765|Secondary|Montreal Cognitive Assessment (MoCA)|MoCA scores at discharge will be reported in order to assess the occurrence of postoperative cognitive decline. Blinded study staff trained in administering the assessments will collect the data. MoCA is scored on a scale from 0 [worst] to 30 [best]; ǂA MoCA score of 24 would be equivalent to an Mini-Mental State Examination (MMSE) of about 27 or 28. Depending on education and peak intellectual attainment, such a score could be consistent with being either cognitively normal, or having very early mild cognitive impairment. Certainly such a person would be capable of living independently in the community and managing most or all of their affairs.|On the day of discharge, an average of 6 days|This is a 2 x 2 cross over study.|||score on a scale||Inter-Quartile Range|Median
2569119|NCT02546765|Secondary|Postoperative Opioid Consumption in Morphine Equivalents|Defined by the amount of additional opioid (IV morphine or hydromorphone) and oral acetaminophen medications required in the first 48 hours postoperatively. Values will be converted to morphine equivalents for analysis. Total morphine equivalent is calculated as the sum of (fentanyl dose x 100)+(hydromorphone dose x 4)+morphine dose+(oxycodone dose x 1.5)|Participants will be followed for the first 48 hours postoperatively.|This is a 2 x 2 cross over study.|||mcg||Inter-Quartile Range|Median
2569120|NCT02546765|Secondary|Severity of Delirium|Severity of delirium will be analyzed, measured from 24 hours post-operation and daily until discharge. The worst severity experienced while in the hospital will be analyzed. Delirium will be defined as an acute change in pre-operative baseline condition with additional features of inattention and either disorganized thinking and altered loss of consciousness, as defined by the Confusion Assessment Method Severity Score (CAM-S, Confusion Assessment Method-Severity). range 0 [best/no delirium] to 19 [worst]; Minimal Clinical Important Difference (MCID) 2 points|Participants will be followed for the duration of the hospital stay, an average of 6 days|This is a 2 x 2 cross over study. Therefore, participants were analyzed for primary analgesic use (N=60 in each group)|||units on a scale||Inter-Quartile Range|Median
2569121|NCT02546765|Secondary|Duration of Delirium|Duration of delirium will be analyzed, measured from 24 hours post-operation and daily until discharge. Additional measurements will be made at 1 month and 1 year after discharge. Delirium will be defined as an acute change in pre-operative baseline condition with additional features of inattention and either disorganized thinking and altered loss of consciousness, as defined by the Confusion Assessment Method (CAM).|Participants will be followed for the duration of the hospital stay, an average of 6 days, and at 1 month and 1- year following the date of surgery|This is a 2 x 2 cross over study. Therefore, participants were analyzed for primary analgesic use (N=60 in each group)|||days||Inter-Quartile Range|Median
2569122|NCT02546765|Primary|Incidence of Delirium|Incidence of delirium will be analyzed between patients treated with and without IV acetaminophen, measured from 24 hours post-operation and daily until discharge. Delirium will be defined as an acute change in pre-operative baseline condition with additional features of inattention and either disorganized thinking and altered loss of consciousness, as defined by the Confusion Assessment Method (CAM).|Participants will be followed for the duration of the hospital stay, an average of 5 days|This is a 2 x 2 cross over study.|||Participants|||Count of Participants
2569123|NCT02546609|Secondary|Change in Insulin Sensitivity (HOMA-IR)|HOMA-IR levels will be examined by standard blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the change in geometric mean (SE) in HOMA-IR from Baseline to Week 16 was assessed. The difference in the actual participants analyzed and per protocol population is due to missing or technically erroneous data.|||mU/L||Standard Error|Geometric Mean
2569124|NCT02546609|Secondary|Change in C-reactive Protein|CRP levels will be examined by standard blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the geometric mean change (SE) in C-reactive protein from Baseline to Week 16 was assessed. The difference in the actual participants analyzed and per protocol population is due to missing or technically erroneous data.|||mg/L||Standard Error|Geometric Mean
2569125|NCT02546609|Secondary|Change in Triglycerides|Lipid levels such as triglycerides will be examined by standard blood chemistry|Baseline, Day 112|Geometric mean values are presented since the data were skewed. Corresponding arithmetic mean changes from baseline for Treatments A, B and C in the Per Protocol Population were +54.9, -48.9 and -28.0 mg/dL respectively. This accounts for the p-value of p=0.0129 for Treatment B.|||mg/dL||Standard Error|Geometric Mean
2569126|NCT02546609|Secondary|Change in Low Density Lipoproteins (LDL)|Lipid levels such as LDL will be examined by standard blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the mean change (SD) in LDL from Baseline to Week 16 was assessed. The difference in the actual participants analyzed and per protocol population is because LDL could not be calculated for some participants.|||mg/dL||Standard Deviation|Mean
2569127|NCT02546609|Secondary|Change in Blood Lipids (High Density Lipoprotein:HDL)|Lipid levels such as HDL will be examined by standard blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the mean change (SD) in LDL from Baseline to Week 16 was assessed. The difference in the actual participants analyzed and per protocol population is because HDL could not be calculated for some participants.|||mg/dL||Standard Deviation|Mean
2569128|NCT02546609|Secondary|Change in Blood Lipids (Cholesterol)|Lipid levels such as cholesterol will be examined by standard blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the mean change (SD) in total cholesterol from Baseline to Week 16 was assessed.|||mg/dL||Standard Deviation|Mean
2569129|NCT02546609|Secondary|Change in Insulin|Insulin levels will be examined through standard blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the mean change (SD) in insulin from Baseline to Week 16 was assessed. The difference in the actual participants analyzed and per protocol population is due to missing or technically erroneous data.|||μIU/mL||Standard Deviation|Mean
2569130|NCT02546609|Secondary|Change in Fasting Glucose|Fasting glucose will be examined through standard fasting blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the mean change (SD) in fasting glucose from Baseline to Week 16 was assessed. The difference in the actual participants analyzed and per protocol population is due to missing or technically erroneous data.|||mg/dL||Standard Deviation|Mean
2569131|NCT02546609|Secondary|Change in Heamoglobin A1c (HbA1c)|HbA1c will be examined through standard blood chemistry|Baseline, Day 112|For the Per-Protocol Population (N=70), the mean change (SD) in HbA1c from Baseline to Week 16 was assessed.|||percentage||Standard Deviation|Mean
2570387|NCT02530671|Secondary|Comparison of BSI Between Periods||0-3, 9-12 months||||percentage of the original bristle field||Standard Deviation|Mean
2569134|NCT02546609|Primary|Change in Hepatic Fat|To evaluate the change in hepatic fat content assessed by proton-density-fat-fraction (PDFF) employing magnetic resonance imaging (MRI).|Baseline, Day 112|For the Per-Protocol Population (N=70), the mean percent change (SD) in hepatic fat content (%) from Baseline to Week 16 (Day 112) for each treatment group was assessed.|||percentage||Standard Deviation|Mean
2569135|NCT02546570|Secondary|Salivary Oxytocin|Expect within-session (30 min) increase in peripheral salivary oxytocin level during OT sessions (within-session), and higher OT levels in oxytocin administration vs. placebo sessions. Peripheral OT levels measured with Salivettes (sterile cotton participants will be asked to chew on for 1 minutes).|Within session (30 min) and between sessions (1 week); saliva samples collected twice (before and after OT administration) at both second and third visits, one week apart|Saliva samples were collected as outlined. The research team attempted to analyze them. However, despite best efforts, and assurances from the manufacturer, the assay performance remained unacceptable primarily in regards to inadequate sensitivity and significant variability in sample duplicates. Therefore, there are no results to report.||||||
2569136|NCT02546570|Primary|fMRI Analysis: Change in vmPFC Region|"Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions.~Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline."|1 week; fMRI data collected at second and third visits, one week apart|Data for all enrolled are summarized.|||percentage of area activation||95% Confidence Interval|Mean
2569137|NCT02546570|Primary|fMRI Analysis: Change in rACC Region|"Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions.~Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline."|1 week; fMRI data collected at second and third visits, one week apart|Data for all enrolled are summarized.|||percentage of area activation||95% Confidence Interval|Mean
2569138|NCT02546570|Primary|fMRI Analysis: Change in mOFC Region|"Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions.~Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline."|1 week; fMRI data collected at second and third visits, one week apart|Data for all enrolled are summarized.|||percentage of area activation||95% Confidence Interval|Mean
2569139|NCT02546570|Primary|fMRI Analysis: Change in dACC Region|"Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions.~Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline."|1 week; fMRI data collected at second and third visits, one week apart|Data for all enrolled are summarized.|||percentage of area activation||95% Confidence Interval|Mean
2569140|NCT02546570|Primary|fMRI Analysis: Change in Amygdala Region|"Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions.~Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline."|1 week; fMRI data collected at second and third visits, one week apart|Data for all enrolled are summarized.|||percentage of area activation||95% Confidence Interval|Mean
2569141|NCT02546570|Primary|fMRI Analysis: Change in Accumbens Region|"Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions.~Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline."|1 week; fMRI data collected at second and third visits, one week apart|Data for all enrolled are summarized.|||percentage of area activation||95% Confidence Interval|Mean
2569142|NCT02546570|Primary|fMRI Analysis: Change in Anterior Insula Region|"Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions.~Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline."|1 week; fMRI data collected at second and third visits, one week apart|Data for all enrolled are summarized.|||percentage of area activation||95% Confidence Interval|Mean
2569143|NCT02546544|Secondary|Number of Participants With a Metabolic Response as Evaluated by EORTC 1.0|"Metabolic response measured by PERCIST v1.0 using SULpeak. This methodology used SULpeak to measure change in glucose uptake in the tumour.~Complete Metabolic Response - Complete resolution of 18F-FDG uptake within measurable target lesion so that it is less than mean liver activity and indistinguishable from surrounding background blood-pool levels.~Partial Metabolic Response - Reduction of minimum of 30% in target measurable tumour 18F-FDG SULpeak. Absolute drop in SUL must be at least 0.8 SUL units, as well. No new lesions.~Positive Metabolic Response - Participants having either Complete Metabolic Response or Partial Metabolic Response.~Stable Metabolic Disease - Not CMR, PMR or PMD. Progressive metabolic disease - Increase of more than 30% in 18F-FDG SUL peak. OR: Visible increase in extent of 18F-FDG tumour uptake (75% in TLG volume with no decline in SUL. OR: New 18F-FDG-avid lesions that are typical of cancer and not related to treatment effect or infection."|Measured cycle 1 day 15||||Participants|||Count of Participants
2569144|NCT02546544|Secondary|Number of Participants With a Radiological Response as Evaluated by RECIST v1.1|"Radiological response measured using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)~Per RECIST for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable disease (SD), Not CR, PR or PD."|Measured cycle 1 day 15, cycle 3 and cycle 6||||Participants|||Count of Participants
2569145|NCT02546544|Secondary|Pharmacokinetics Assays of Following Linsitinib Treatment (Plasma Concentrations of Linsitinib)|"Plasma concentrations of linsitinib (ng/ml).~Samples were taken 3 hours post-dose at Cycle 1 days 1,15,17, Cycle 2 day 3, Cycle 3 days 1 and 3, Cycle 4 day 1, Cycle 5 day 1, Cycle 6 day 1, and End of Treatment (this could occur at anytime during the 6 cycles)."|Cycle 1 days 1,15,17, Cycle 2 day 3, Cycle 3 days 1 and 3, Cycle 4 day 1, Cycle 5 day 1, Cycle 6 day 1 and End of Treatment.0|Data provided is as collected.|||ng/ml||Full Range|Median
2569146|NCT02546544|Secondary|Clinical Outcome (PFS, DSS)|"To determine the clinical outcome through assessment of~Progression free survival; where length of survival is defined in whole days as the time from entry into the study until Ewing sarcoma progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.~Disease specific survival; where length of survival is defined in whole days as the time from entry into the study until death from Ewing sarcoma."|Duration of study (up to 18 months)||||months||95% Confidence Interval|Median
2569147|NCT02546544|Primary|Number of Participants With a Toxic Event|A patient is defined as having a toxic event if they experienced at least one grade 3 adverse event (CTCAE v4.0 grade)|Following 6 cycles of treatment (up to 6 months)||||Participants|||Count of Participants
2569148|NCT02546544|Primary|Number of Participants With a Metabolic Response as Evaluated by PERCIST v1.0|"Metabolic response measured by PERCIST v1.0 using SULpeak. This methodology used SULpeak to measure change in glucose uptake in the tumour.~Complete Metabolic Response - Complete resolution of 18F-FDG uptake within measurable target lesion so that it is less than mean liver activity and indistinguishable from surrounding background blood-pool levels.~Partial Metabolic Response - Reduction of minimum of 30% in target measurable tumour 18F-FDG SULpeak. Absolute drop in SUL must be at least 0.8 SUL units, as well. No new lesions.~Positive Metabolic Response - Participants having either Complete Metabolic Response or Partial Metabolic Response.~Stable Metabolic Disease - Not CMR, PMR or PMD. Progressive metabolic disease - Increase of more than 30% in 18F-FDG SUL peak. OR: Visible increase in extent of 18F-FDG tumour uptake (75% in TLG volume with no decline in SUL. OR: New 18F-FDG-avid lesions that are typical of cancer and not related to treatment effect or infection."|Pre- and Post- dose responses following 1 cycle (21 days) of treatment||||Participants|||Count of Participants
2569149|NCT02546388|Secondary|Effect of Treatment|To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.|1 hour|Only one patient underwent a repeat Dotatate PET/CT scan to investigate treatment response in our study|||Participants|||Count of Participants
2569150|NCT02546388|Primary|Number of Participants Characterized by Abnormal or Negative Uptake|To correlate localization and number of increased radiotracer foci between FDG-PET and DOTATATE studies.|1 hour|We initially planned to do OctreoScan, but Dotatate became FDA approved in the process. Due to the superior image quality, lower radiation, and shorter protocol for Dotatate, we decided to abandon OctreoScan.|||Participants|||Count of Participants
2569151|NCT02546375|Secondary|Duration of Bosutinib Therapy|The duration from initiation of Bosutinib therapy up to the end of Bosutinib therapy was reported in this outcome measure.|Baseline up to 5.5 years|All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib.|||months||Full Range|Median
2569152|NCT02546375|Secondary|Relative Bosutinib Dose Intensity|Relative dose intensity was defined as the percentage of daily dose received over the expected daily dose of the study drug.|Baseline up to 5.5 years|All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib.|||percentage of daily dose|||Number
2569153|NCT02546375|Secondary|Mean Dose of Bosutinib at Initiation of Treatment||Baseline up to 5.5 years|All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib.|||milligram per day||Standard Deviation|Mean
2569154|NCT02546375|Secondary|Cross-Intolerance Between Bosutinib and Previous Therapy|Cross-intolerance was defined as percentage of participants who permanently discontinued bosutinib due to an adverse event which also resulted in discontinuation of a previous treatment (imatinib, dasatinib, nilotinib).|Baseline up to 5.5 years|All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib.|||percentage of participants|||Number
2569155|NCT02546375|Secondary|Percentage of Participants With Permanent Discontinuation From Bosutinib Therapy||Baseline up to 5.5 years|All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib.|||percentage of participants|||Number
2569156|NCT02546375|Secondary|Percentage of Participants With Disease Progression|Progression was defined as change from CP-CML to AP-CML or to BC-CML. CP-CML is frequently asymptomatic and diagnosed with <10% blasts. Based on the ELN 2013 definition: AP-CML was defined by the presence of blast cells between 15-29% or blast cells plus promyelocytes >30%, with blasts <30% in blood or bone marrow, platelet count <100*10^9 or clonal chromosome abnormalities in Ph+ cells. BC-CML was defined as blasts in blood or bone marrow >=30%, extramedullary blast proliferation (excluding spleen), large foci or clusters of blasts in bone marrow biopsy.|Year 1, 2, 3|All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure and number analyzed (n) signifies those participants who were evaluable at specified time points only.|||percentage of participants|||Number
2569157|NCT02546375|Secondary|Overall Survival (OS)|OS was defined as the duration from initiation of Bosutinib therapy to date of death (all causes combined). For participants who were alive or lost to follow-up (LTFU), overall survival was censored on the date of data collection or date LTFU, respectively.|From baseline up to 1 Year, baseline up to Year 2, baseline up to Year 3|All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib.|||years||95% Confidence Interval|Median
2569158|NCT02546375|Secondary|Progression-free Survival (PFS)|PFS was defined as the duration between initiation of Bosutinib therapy and date of progression estimated by the treating physician or death of participant (all causes combined). Progression was defined as change from chronic phase of CML (CP-CML) to accelerated phase of CML (AP-CML) or to blast crisis of CML (BC-CML). CP-CML is frequently asymptomatic and diagnosed with <10% blasts. Based on the ELN 2013 definition: AP-CML was defined by the presence of blast cells between 15-29% or blast cells plus promyelocytes >30%, with blasts <30% in blood or bone marrow, platelet count <100*10^9 or clonal chromosome abnormalities in Ph+ cells. BC-CML was defined as blasts in blood or bone marrow >=30%, extramedullary blast proliferation (excluding spleen), large foci or clusters of blasts in bone marrow biopsy. Participants who were alive at the date of last assessment were censored on the date of data collection.|Year 1, 2, 3|All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib.|||years||95% Confidence Interval|Median
2569159|NCT02546375|Secondary|Percentage of Participants With Treatment Related Adverse Events (AEs) Greater Than or Equal to Grade 3|Treatment-related AE was any untoward medical occurrence attributed to Bosutinib in a participant who received Bosutinib. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death.|Baseline up to 5.5 years|All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib.|||percentage of participants|||Number
2569160|NCT02546375|Secondary|Percentage of Participants With Treatment Related Adverse Events (AEs)|Treatment-related AE was any untoward medical occurrence attributed to Bosutinib in a participant who received Bosutinib. Relatedness to Bosutinib was assessed by the investigator.|Baseline up to 5.5 years|All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib.|||percentage of participants|||Number
2569161|NCT02546375|Primary|Percentage of Participants With Cumulative Major Molecular Response (MMR)/Molecular Response 3.0 (MR3.0)|Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MMR was defined as a BCR-ABL1 to ABL1 less than or equal to (<=) 0.1% on the IS.|Baseline up to 5.5 years|All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2569162|NCT02546375|Primary|Percentage of Participants With Cumulative Complete Molecular Response 4.5 (MR4.5)|Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MR4.5 was defined and recorded as detectable disease with <0.0032% BCR-ABL1 transcripts on IS or undetectable disease in cDNA with >32,000 ABL1 transcripts in the same volume of cDNA used to test for BCR-ABL1 transcripts.|Baseline up to 5.5 years|All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2569176|NCT02546362|Secondary|Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 12-week Timepoint|Patient Reported Outcomes Measurement Information System (PROMIS) score for depression is ranging from 8 to 40 where higher score is associated with higher depression level.|between baseline and 12-week timepoint||||score on a scale||Standard Deviation|Mean
2569340|NCT02544074|Secondary|eSAGE Score Compared to the Boston Naming Test Score|The investigators will compare the eSAGE scores to the Boston Naming Test score. The Boston Naming Test consists of 60 pictures of nouns that subjects must try to name. Associations will be investigated using Spearman correlations.|3 hours||||spearman rank correlation|||Number
2569163|NCT02546375|Primary|Percentage of Participants With Cumulative Complete Molecular Response 4.0 (MR4.0)|Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MR4.0 was defined and recorded as detectable disease with <0.01% BCR-ABL1 transcripts on IS or undetectable disease in cDNA with greater than (>) 10,000 ABL1 transcripts in the same volume of cDNA used to test for BCR-ABL1 transcripts.|Baseline up to 5.5 years|All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2569164|NCT02546375|Primary|Percentage of Participants With Cumulative Partial Cytogenetic Response (PCyR)|CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. PCyR was indicated by presence of 1-35% Ph+ cells from CBA of bone marrow metaphases.|Baseline up to 5.5 years|All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2569165|NCT02546375|Primary|Percentage of Participants With Cumulative Minimal Cytogenetic Response (mCyR)|CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. mCyR was indicated by presence of 66-95% Ph+ cells from CBA of bone marrow metaphases.|Baseline up to 5.5 years|All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2569166|NCT02546375|Primary|Percentage of Participants With Cumulative Minor Cytogenetic Response (MCyR)|CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. MCyR was indicated by presence of 36-65% Ph+ cells from CBA of bone marrow metaphases.|Baseline up to 5.5 years|All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2569167|NCT02546375|Primary|Percentage of Participants With Cumulative Complete Cytogenetic Response (CCyR)|Cytogenetic response (CyR) used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by chromosome banding analysis (CBA) or fluorescence in situ hybridisation (FISH). CCyR was indicated by absence of Philadelphia chromosome positive (Ph+) cells metaphases from FISH of blood interphase cell nuclei.|Baseline up to 5.5 years|All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2569168|NCT02546375|Primary|Percentage of Participants With Cumulative Partial Haematological Response (PHR)|Haematological response used blood sample of the participants to evaluate response to treatment for CML.|Baseline up to 5.5 years|All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2569169|NCT02546375|Primary|Percentage of Participants With Cumulative Complete Haematological Response (CHR)|Haematological response used blood sample of the participants to evaluate response to treatment for CML. Based on the European LeukemiaNet (ELN) 2013 definition: CHR is defined as platelet count less than (<) 450*10^9 per liter, white blood cells count <10*10^9 per liter, no immature granulocytes and <5 percent (%) basophils on differential and a non-palpable spleen.|Baseline up to 5.5 years|All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2569170|NCT02546362|Secondary|Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 12-week Timepoint|Multiple Ability Self-report Questionnaire (MASQ) score is ranging from 38 to 190, where higher score indicates more difficulty.|between baseline and 12-week timepoint||||score on a scale||Standard Deviation|Mean
2569171|NCT02546362|Secondary|Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 4-week Timepoint|Multiple Ability Self-report Questionnaire (MASQ) score is ranging from 38 to 190, where higher score indicates more difficulty.|between baseline and 4-week timepoint||||score on a scale||Standard Deviation|Mean
2569172|NCT02546362|Secondary|Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 12-week Timepoint|Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance is ranging from 8 to 40 where higher score is associated with higher sleep disturbance level.|between baseline and 12-week timepoint||||score on a scale||Standard Deviation|Mean
2569173|NCT02546362|Secondary|Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 4-week Timepoint|Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance is ranging from 8 to 40 where higher score is associated with higher sleep disturbance level.|between baseline and 4-week timepoint||||score on a scale||Standard Deviation|Mean
2569174|NCT02546362|Secondary|Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 12-week Timepoint|Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue is ranging from 8 to 40 where higher score is associated with higher fatigue level.|between baseline and 12-week timepoint||||score on a scale||Standard Deviation|Mean
2569175|NCT02546362|Secondary|Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 4-week Timepoint|Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue is ranging from 8 to 40 where higher score is associated with higher fatigue level.|between baseline and 4-week timepoint||||score on a scale||Standard Deviation|Mean
2569177|NCT02546362|Secondary|Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 4-week Timepoint|Patient Reported Outcomes Measurement Information System (PROMIS) score for depression is ranging from 8 to 40 where higher score is associated with higher depression level.|between baseline and 4-week timepoint||||score on a scale||Standard Deviation|Mean
2569178|NCT02546362|Secondary|Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 12-week Timepoint|EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS score is defined on a Visual Analogue Scale (VAS) ranging from 0 (= worth imaginable health state) to 100 (=best imaginable health state).|between baseline and 12-week timepoint||||score on a scale||Standard Deviation|Mean
2569179|NCT02546362|Secondary|Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 4-week Timepoint|EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS score is defined on a Visual Analogue Scale (VAS) ranging from 0 (= worth imaginable health state) to 100 (=best imaginable health state).|between baseline and 4-week timepoint||||score on a scale||Standard Deviation|Mean
2569180|NCT02546362|Secondary|Patient Global Impression of Change (PGIC) at 12-week Timepoint|Patient Global Impression of Change (PGIC) is defined on a 7-level scale where 1=very much improved and 7=very much worse (4=no change).|at 12-week timepoint||||score on a scale||Standard Deviation|Mean
2569181|NCT02546362|Secondary|Patient Global Impression of Change (PGIC) at 4-week Timepoint|Patient Global Impression of Change (PGIC) is defined on a 7-level scale where 1=very much improved and 7=very much worse (4=no change).|at 4-week timepoint||||score on a scale||Standard Deviation|Mean
2569182|NCT02546362|Secondary|Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 4-week Timepoint|Fibromyalgia Impact Questionnaire-revised (FIQR) total score is ranging from 0 to 100, where lower score corresponds to a better quality of life.|between baseline and 4-week timepoint||||score on a scale||Standard Deviation|Mean
2569183|NCT02546362|Secondary|Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 4-week Timepoint|Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) is defined on a numeric rating scale scoring the pain between 0 (=no pain) and 10 (=unbearable pain).|between baseline and 4-week timepoint||||score on a scale||Standard Deviation|Mean
2569184|NCT02546362|Primary|Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 12-week Timepoint|Fibromyalgia Impact Questionnaire-revised (FIQR) total score is ranging from 0 to 100, where lower score corresponds to a better quality of life.|between baseline and 12-week timepoint||||score on a scale||Standard Deviation|Mean
2569185|NCT02546362|Primary|Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 12-week Timepoint|Pain intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) pain score) is defined on a numeric rating scale scoring the pain between 0 (=no pain) and 10 (=unbearable pain).|between baseline and 12-week timepoint||||score on a scale||Standard Deviation|Mean
2569186|NCT02546323|Secondary|Percent Change From Baseline in Lipid and Lipoprotein Values at Final Visit: Time Weighted Average|The percent change from baseline at final visit for lipid and lipoprotein measurements (LDL-C, total cholesterol, HDL-C, triglycerides, non-HDL-C, non-HDL-C/HDL-C ratio) was determined by ANCOVA with treatment as a fixed effect and baseline value as a covariate. In the evaluation of change from baseline (Week 0), the time-weighted average value was calculated as the value multiplied by the number of days since the last assessment, summed for all observations, and divided by the sum of days between all visits.|From baseline (Week 0) to end-of-study (Week 104).|The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.|||Percent change||Standard Error|Least Squares Mean
2569187|NCT02546323|Secondary|Percent Change From Baseline in Lipid, Lipoprotein and Apolipoprotein Values at Final Visit: Last Observation Carried Forward (LOCF)|The percent change from baseline at final visit for lipid and lipoprotein measurements (low-density lipoprotein cholesterol [LDL-C], total cholesterol, high-density lipoprotein cholesterol [HDL-C], triglycerides, non-HDL-C, non-HDL-C/HDL-C ratio) and apolipoprotein measurements (apolipoprotein A-I [ApoA-I], apolipoprotein B [ApoB] and ApoB/ApoA-I ratio) was determined by analysis of covariance (ANCOVA) with treatment as a fixed effect and baseline value as a covariate. In the evaluation of change from baseline (Week 0) to the final visit at Week 104, any missing observations were imputed by LOCF.|From baseline (Week 0) to end-of-study (Week 104).|The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.|||Percent change||Standard Error|Least Squares Mean
2569188|NCT02546323|Secondary|Annualized Rate of Change in the Mean of the Mean (MeanMean) CIMT of the Near and Far Walls of the Right and Left CCA|CIMT measurements were made from ultrasound images of the near and far walls of the right and left CCA. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the mean of the CIMT for this segment. The annualized rate of change in the MeanMean CIMT measurements, based on all scans performed during the study, was determined using a multi-level mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits.|From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).|The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.|||mm/year||Standard Error|Mean
2569201|NCT02546193|Secondary|Mean Estimated Blood Loss at Delivery|Estimated total blood loss at time of delivery in milliliters.|End of the third stage of labor, approximately 16 hours after admission||||milliters||Standard Deviation|Mean
2569202|NCT02546193|Secondary|Number of Participants With Normal Spontaneous Vaginal Delivery||End of the third stage of labor, approximately 16 hours after admission||||Participants|||Count of Participants
2569203|NCT02546193|Secondary|Mean Time of Delivery|Time from admission to the hospital to delivery of the placenta.|End of the third stage of labor, approximately 16 to 30 hours after admission||||hours||Standard Deviation|Mean
2569204|NCT02546193|Secondary|Mean Dose of Medication for Pain Relief|Mean dose of opioid pain medication (Fentanyl) in micrograms|End of the third stage of labor, approximately 16 hours after admission||||micrograms||Standard Deviation|Mean
2569189|NCT02546323|Secondary|Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left ICA|CIMT measurements were made from ultrasound images of the near and far walls of the right and left ICA. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for this segment. The annualized rate of change in the MeanMax CIMT measurements, based on all scans performed during the study, was determined using a multi-level mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits.|From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).|The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.|||mm/year||Standard Error|Mean
2569190|NCT02546323|Secondary|Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left Carotid Bulb|CIMT measurements were made from ultrasound images of the near and far walls of the right and left carotid bulb. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for this segment. The annualized rate of change in the MeanMax CIMT measurements, based on all scans performed during the study, was determined using a multi-level linear mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits.|From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).|The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.|||mm/year||Standard Error|Mean
2569191|NCT02546323|Secondary|Annualized Rate of Change in the MeanMax CIMT of the Near and Far Walls of the Right and Left CCA|CIMT measurements were made from ultrasound images of the near and far walls of the right and left CCA. The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. The 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for this segment. The annualized rate of change in the MeanMax CIMT measurements, based on all scans performed during the study, was determined using a multi-level linear mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits.|From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).|The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.|||mm/year||Standard Error|Mean
2569192|NCT02546323|Primary|Annualized Rate of Change in Mean of the Maximum (MeanMax) CIMT Measurements From Each of the 12 Carotid Artery Sites Based on All Scans Performed During the 104-Week Study Period|CIMT measurements were made from ultrasound images of the common carotid artery (CCA), carotid bulb and internal carotid artery (ICA). The thickness of the intima and media was determined as the distance from the interface between the vessel lumen and the intima, to the interface between the media and the adventitia. Twelve carotid artery sites were scanned at each visit and the 3 images recorded at the 3 interrogation angles were measured to determine the maximum of the CIMT for a specific segment. The annualized rate of change in the MeanMax CIMT measurements from each of the 12 sites, based on all scans performed during the study, was determined using a multi-level linear mixed effects regression model that estimated mean annualized rate of change (mm/year) over the 104-week study period. The model fitted regression lines to profiles of CIMT values consisting of 2 pre-randomization values, 3 values from visits during the treatment period, and 2 end-of-study visits.|From baseline (pre-randomization Week -2 and Week -4) to end-of-study (Week 104).|The ITT analysis set consisted of all randomized patients. Patients were analyzed according to the treatment to which they were randomized.|||mm/year||Standard Error|Mean
2569193|NCT02546193|Secondary|Number of Infants With Neonatal Morbidity or Mortality, Categorized by Reason.|Any diagnosed neonatal morbid condition or mortality prior to hospital discharge.|Neonatal discharge from the hospital, approximately 2-3 days after delivery||||Participants|||Count of Participants
2569194|NCT02546193|Secondary|Mean Umbilical Cord Blood Gases|Mean infant venous pH reported from complete umbilical cord blood gases.|Neonatal discharge from the hospital, approximately 2-3 days after delivery||||pH||Standard Deviation|Mean
2569195|NCT02546193|Secondary|Mean APGAR Scores|APGAR (Appearance, Pulse, Grimace, Activity, Respiration) Scoring System. 1-10 scale with higher total score indicating better newborn health. Infant mean APGAR score at 5 minutes reported.|Neonatal discharge from the hospital, approximately 2-3 days after delivery||||score on a scale||Standard Deviation|Mean
2569196|NCT02546193|Secondary|Mean Birth Weight|Mean infant birth weight reported in grams.|Neonatal discharge from the hospital, approximately 2-3 days after delivery||||grams||Standard Deviation|Mean
2569197|NCT02546193|Secondary|Number of Infants Per Gender|Gender defined as male or female.|Neonatal discharge from the hospital, approximately 2-3 days after delivery||||Participants|||Count of Participants
2569198|NCT02546193|Secondary|Mean Readmission Rate|Defined as readmission to the hospital for any reason within 6 weeks from the date of delivery.|Final postpartum visit, approximately 42 days after delivery||||readmissions||Standard Deviation|Mean
2569199|NCT02546193|Secondary|Number of Participants With Postpartum Complications|Postpartum complications defined as postpartum hemorrhage, depression, urinary tract infection, wound infection, endomyometritis, mastitis, pyelonephritis, intra-abdominal infection, deep vein thrombosis, pulmonary thrombosis, cardiac complication, or fever of unknown origin.|Final postpartum visit, approximately 42 days after delivery||||Participants|||Count of Participants
2569200|NCT02546193|Secondary|Number of Participants With Intrapartum Complications|Intrapartum complications defined as intrapartum fever, placental abruption, or chorioamnionitis.|Final postpartum visit, approximately 42 days after delivery||||Participants|||Count of Participants
2569206|NCT02546193|Secondary|Mean Score on Maternal Satisfaction Survey|This survey will gauge the mother's experience during her induction with regard to pain, rest, concerns during the induction, satisfaction, and willingness to recommend their particular induction setting (inpatient vs. outpatient). Questions are based on a 1-4 scale, with higher scores indicating greater satisfaction.|Discharge from the hospital, approximately 2-3 days after delivery||||score on a scale||Standard Deviation|Mean
2569207|NCT02546193|Primary|Pre-delivery Hospitalization Time|The time from when the patient is admitted to the hospital until she delivers her infant and placenta will be recorded. For the outpatient group, this will be measured by adding together the time that the patient spends in the Family Birth Center during Foley placement in the evening with the time she spends inpatient the next day during the rest of her induction until delivery.|Delivery, approximately 16 to 30 hours after admission||||minutes||Standard Deviation|Mean
2569208|NCT02545868|Secondary|Percentage of Participants With Adverse Events (AEs), Serious AEs, or AEs Leading to Study Discontinuation|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious AE is any AE that is fatal, life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug, or is a significant medical event in the investigator's judgment.|During ISP (24 weeks for Group A and 12 weeks for Group B)|Safety population included all participants who received any ocrelizumab or any vaccine.|||percentage of participants|||Number
2569209|NCT02545868|Secondary|Percentage of Participants With Anti-Drug Antibody Formation|Anti-Drug Antibodies (ADA) may induce unwanted side effects, especially in biotechnology-derived pharmaceuticals, such as therapeutic antibodies and growth factors.|Up to 24 Weeks (ISP)|Safety population included all participants who received any ocrelizumab or any vaccine. Data are reported for participants with measurable ADA samples.|||percentage of participants|||Number
2569210|NCT02545868|Secondary|Total Immunoglobulin||Days 1, 85, and 169|Safety population included all participants who received any ocrelizumab or any vaccine.|||grams per liter (g/L)||Standard Deviation|Mean
2569211|NCT02545868|Secondary|Cellular Immune Response Assessed by Flow Cytometry|"Flow cytometry is a laser-based technology commonly used for cell counting and sorting. In this study, this outcome measure is focusing on a single variable, CD19 count (total B cells). LLN = 80 cells/ul.~Repleted is defined as CD19 >= LLN or baseline, whichever is lower."|Days 1, 15, 85, 112, 140 and 169|Safety population included all participants who received any ocrelizumab or any vaccine. Data are reported for evaluable participants.|||percentage of participants|||Number
2569212|NCT02545868|Secondary|MRI Parameters: Total Number of Lesions|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP.|||lesions||Standard Deviation|Mean
2569213|NCT02545868|Secondary|MRI Parameters: T1 Unenhancing Lesion Volume|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP.|||cm^3||Standard Deviation|Mean
2569214|NCT02545868|Secondary|MRI Parameters: Cortical Grey Matter Volume|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP.|||cm^3||Standard Deviation|Mean
2569215|NCT02545868|Secondary|MRI Parameters: Volume of T2 Lesions: White Matter Volume|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP.|||cm^3||Standard Deviation|Mean
2569216|NCT02545868|Secondary|MRI Parameters: Normalized Brain Volume|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP.|||cm^3||Standard Deviation|Mean
2569217|NCT02545868|Secondary|MRI Parameters: Categorical Number of Gd-enhancing T1 Lesions|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP. Data are reported for evaluable participants.|||participants|||Number
2569218|NCT02545868|Secondary|MRI Parameters: Number of Gadolinium (Gd)-Enhancing T1 Lesions|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP.|||lesions||Standard Deviation|Mean
2569219|NCT02545868|Secondary|MRI Parameters: Categorical Number of T2 Lesions|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP. Data are reported for evaluable participants.|||participants|||Number
2569220|NCT02545868|Secondary|MRI Parameters: Number of T2 Lesions|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP.|||lesions||Standard Deviation|Mean
2569221|NCT02545868|Secondary|Magnetic Resonance Imaging (MRI) Parameters: Volume of T2 Lesions|MRI assessments done to evaluate the long-term effects of ocrelizumab on MRI parameters.|Baseline|OC population included all randomized participants who completed the ISP.|||cubic centimeters (cm^3)||Standard Deviation|Mean
2569222|NCT02545868|Secondary|Ratio of Strain-Specific Geometric Mean Titer Levels Postvaccination to Prevaccination|Strain-specific GMT ratios were calculated as post-vaccination : pre-vaccination.|Immediately prior to and 4 weeks after influenza vaccine|OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).|||ratio||Standard Deviation|Geometric Mean
2569223|NCT02545868|Secondary|Strain-Specific Geometric Mean Titer Levels|Geometric mean titers (GMTs) in participants in Groups A2 and B were measured 4 weeks after vaccination.|Baseline and Week 4|OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).|||hemagglutination inhibition titers||95% Confidence Interval|Geometric Mean
2569312|NCT02544451|Secondary|Absolute Change in Height-for-age Z-score|z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean.|From Parent Study Baseline at Week 96|FAS.|||z-score||95% Confidence Interval|Least Squares Mean
2569224|NCT02545868|Secondary|Percentage of Participants With Seroconversion|Seroconversion at 4 weeks after vaccination defined, as per protocol, as a prevaccination HI titer <10 and an HI titer >40 at 4 weeks after vaccination. Seroconversion at 4 weeks after vaccination, defined per FDA guidance, as either a) a pre-vaccination HI titer <10 and HI titer >/= 40 at 4 weeks after vaccination, or b) a pre-vaccination HI titer >/= 10 and at least 4-fold increase in HI antibody titer at 4 weeks after vaccination.|4 weeks after influenza immunization|OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).|||percentage of participants|||Number
2569225|NCT02545868|Secondary|Percentage of Participants With 4-Fold Increase in Strain-Specific HI Titers|4-fold increase from prevaccination HI titer.|4 weeks after seasonal influenza vaccine administration|OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).|||percentage of participants|||Number
2569226|NCT02545868|Secondary|Percentage of Participants With 2-Fold Increase in Strain-Specific HI Titers|2-fold increase from prevaccination HI titer.|4 weeks after seasonal influenza vaccine administration|OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).|||percentage of participants|||Number
2569227|NCT02545868|Secondary|Percentage of Participants With Seroprotection|Seroprotection was defined as specific hemagglutination inhibition (HI) titers >40 at 4 weeks after vaccination.|4 weeks after seasonal influenza vaccine administration|OC population included all randomized participants who completed the ISP. Analysis applies to participants who received influenza vaccine (Groups A2 and B).|||percentage of participants|||Number
2569228|NCT02545868|Secondary|Mean Level of Anti-Pneumococcal Antibody|Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID).|Immediately prior to 23-PPV and 4 and 8 weeks after 23-PPV|OC population included all randomized participants who completed the ISP.|||mcg/mL||95% Confidence Interval|Geometric Mean
2569229|NCT02545868|Secondary|Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 13-PCV|Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or > 1 mcg/mL rise compared with pre-vaccination levels.|8 weeks after 23-PPV, which was 4 weeks after Group A1 participants received 13-PCV|OC population included all randomized participants who completed the ISP.|||percentage of participants|||Number
2569230|NCT02545868|Secondary|Mean Levels of Anti-Pneumococcal Antibody|Serotype-specific antibody levels (IgG) were assessed by bead-based multi-analyte immunodetection (MAID).|Immediately prior to and 4 weeks after 23-PPV|OC population included all randomized participants who completed the ISP.|||mcg/mL||95% Confidence Interval|Geometric Mean
2569231|NCT02545868|Secondary|Percentage of Participants With Positive Response Against >/=12 Pneumococcal Serotypes|Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or > 1 mcg/mL rise compared with pre-vaccination levels.|4 weeks after 23-PPV|OC population included all randomized participants who completed the ISP.|||percentage of participants|||Number
2569232|NCT02545868|Secondary|Percentage of Participants With Positive Response Against >/=2 Pneumococcal Serotypes|Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or > 1 mcg/mL rise compared with pre-vaccination levels.|4 weeks after 23-PPV|OC population included all randomized participants who completed the ISP.|||percentage of participants|||Number
2569233|NCT02545868|Secondary|Percentage of Participants With Positive Response Against Individual Pneumococcal Serotypes in 23-PPV|Positive response against a serotype was defined as a 2-fold increase in anti-pneumococcal antibody level or greater than (>) 1 microgram per milliliter (mcg/mL) rise compared with pre-vaccination levels.|4 weeks after 23-PPV|OC population included all randomized participants who completed the ISP.|||percentage of participants|||Number
2569234|NCT02545868|Secondary|Mean Levels of Anti-KLH Antibody: Ig M|Anti-KLH antibody levels were assessed by ELISA.|Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration|OC population included all randomized participants who completed the ISP.|||titer units||95% Confidence Interval|Geometric Mean
2569235|NCT02545868|Secondary|Mean Levels of Anti-KLH Antibody: Immunoglobulin (Ig) G|Anti-KLH antibody levels were assessed by ELISA.|Immediately prior to first KLH administration and 4, 8, and 12 weeks after first KLH administration|OC population included all randomized participants who completed the ISP.|||titer units||95% Confidence Interval|Geometric Mean
2569236|NCT02545868|Secondary|Mean Levels of Anti-Tetanus Antibody|Anti-tetanus antibody levels were assessed by enzyme-linked immunosorbent assay (ELISA).|Immediately prior to and at 4 and 8 weeks after TT vaccine|OC population included all randomized participants who completed the ISP.|||IU/mL||95% Confidence Interval|Geometric Mean
2569237|NCT02545868|Secondary|Percentage of Participants With Tetanus Antibody Titer >/=0.2 IU/mL or 2-Fold Increase in Tetanus Antibody Titers|For participants with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive response was defined as an antibody titer >/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers >/= 0.1 IU/mL, a positive response was defined as at least a 2-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels.|4 weeks after TT vaccine|OC population included all randomized participants who completed the ISP.|||percentage of participants|||Number
2569238|NCT02545868|Secondary|Percentage of Participants With Positive Response to TT Vaccine Measured 4 Weeks After TT Vaccine|For participants with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive response was defined as an antibody titer >/= 0.2 IU/mL measured 4 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers >/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 4 weeks after vaccination compared with pre-vaccination levels.|4 weeks after TT vaccine|OC population included all randomized participants who completed the ISP.|||percentage of participants|||Number
2569313|NCT02544451|Secondary|Absolute Change in Height||From Parent Study Baseline at Week 96|FAS.|||centimeter (cm)||95% Confidence Interval|Least Squares Mean
2569314|NCT02544451|Secondary|Absolute Change in Weight-for-age Z-score|z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean.|From Parent Study Baseline at Week 96|FAS.|||z-score||95% Confidence Interval|Least Squares Mean
2569239|NCT02545868|Primary|Percentage of Participants With Positive Response to TT Vaccine Measured 8 Weeks After TT Vaccine|For participants with pre-vaccination tetanus antibody titers < 0.1 IU/mL, a positive response was defined as an antibody titer >/= 0.2 IU/mL measured 8 weeks after vaccination. For participants with pre-vaccination tetanus antibody titers >/= 0.1 IU/mL, a positive response was defined as at least a 4-fold increase in antibody titers measured 8 weeks after vaccination compared with pre-vaccination levels.|8 weeks after TT vaccine|OC population included all randomized participants who completed the ISP.|||percentage of participants|||Number
2569240|NCT02545608|Primary|The Efficacy of Restylane Vital on Skin Structure Compared to no Treatment Using a Validated Scale.|Assessment of the severity of hand aging using a 5-point (ranging from 0-5) photo numeric rating scale (Hand Grading Scale), where higher scores mean a worse outcome.|12 weeks|The 9 subjects treated with Restylane Vital in both hands not included|||units on a scale||Standard Deviation|Mean
2569241|NCT02545543|Secondary|Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI)|"The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:~- Geometric mean fold increase (GMFI): geometric mean fold titer rise from Day 1 to Exit Visit"|28 days after last vaccination.|The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.|||Fold Change Titer (GMFI)||95% Confidence Interval|Geometric Mean
2569242|NCT02545543|Secondary|Immunogenicity Endpoint: Seroprotection Rate|"The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:~- The % of subjects with a titer ≥40 (seroprotection rates) at Day 1 and at Exit Visit"|28 days after last vaccination.|The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results|||percentage of participants||95% Confidence Interval|Number
2569243|NCT02545543|Secondary|Immunogenicity Endpoint: Seroconversion Rate (SCR)|"The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:~- SCRs: % of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination titer"|28 days after last vaccination.|The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results.|||percentage of participants||95% Confidence Interval|Number
2569244|NCT02545543|Secondary|Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit)|"The humoral immune response was assessed for Seqirus QIV & comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate:~- Geometric mean of HI titers prevaccination & postvaccination"|28 days after last vaccination.|The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results|||Titer||95% Confidence Interval|Geometric Mean
2569245|NCT02545543|Secondary|Safety Endpoint: The Frequency of Serious Adverse Events (SAEs).|Frequency of serious adverse events (SAEs) for 180 days after the last vaccination dose.|180 days after the last vaccination dose.|The Overall Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable follow-up safety data|||participants|||Number
2569246|NCT02545543|Secondary|Safety Endpoint: The Frequency and Severity of Unsolicited Adverse Events (AEs).|Frequency and severity of unsolicited AEs for at least 28 days (ie, day of vaccination and 27 subsequent days) after each vaccination dose|28 days after each vaccination.|The Overall Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable follow-up safety data.|||participants|||Number
2569247|NCT02545543|Secondary|Safety Endpoint: The Frequency of Cellulitis-like Reaction.|Frequency of cellulitis-like reaction for at least 28 days after each vaccination dose|28 days after each vaccination.|The Solicited Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events.|||participants|||Number
2569248|NCT02545543|Secondary|Safety Endpoint: The Frequency and Severity of Solicited Systemic Adverse Events (AEs).|Frequency and severity of solicited systemic adverse events (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose|7 days after each vaccination.|The Solicited Safety Population comprised all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events.|||participants|||Number
2569249|NCT02545543|Secondary|Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions.|Frequency and severity of solicited local adverse reactions (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose|7 days after each vaccination.|The Solicited Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events.|||participants|||Number
2569250|NCT02545543|Primary|The Difference in Seroconversion Rate (SCR) for Each Virus Strain.|Noninferiority of Seqirus QIV compared to Comparator QIV was assessed by the eight co-primary endpoints of HI geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain. The rate of SCR is defined as the percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination HI titer. For the SCR comparison, the difference between the SCR for each virus strain will be determined.|28 days after last vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||percentage of participants||95% Confidence Interval|Number
2569315|NCT02544451|Secondary|Absolute Change in Weight||From Parent Study Baseline at Week 96|FAS.|||kg||95% Confidence Interval|Least Squares Mean
2569341|NCT02544074|Secondary|eSAGE Score Compared to the Montreal Cognitive Assessment (MoCA) Score|The investigators will compare the eSAGE scores with the Montreal Cognitive Assessment (MoCA) scores. Associations will be investigated using Spearman correlations.|3 hours||||spearman rank correlation|||Number
2569251|NCT02545543|Primary|The Geometric Mean Titer (GMT) Ratio of Each Virus Strain.|Noninferiority of Seqirus QIV compared to comparator QIV was assessed by the eight co-primary endpoints of hemagglutination inhibition (HI) antibody geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain included in the vaccines. The GMT ratio is defined as the geometric mean of the postvaccination HI titer for the US-licensed comparator QIV over the geometric mean of the postvaccination HI titer for Seqirus QIV.|28 days after last vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||Ratio||95% Confidence Interval|Geometric Mean
2569252|NCT02545504|Secondary|Percentage of Participants With Clinically Relevant Treatment-emergent Laboratory Abnormalities|Treatment-emergent laboratory abnormalities were graded per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 where 0=None, 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening. Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any post-baseline time point, up to 30 days after the last dose of all study treatment, or 55 days after the last dose of andecaliximab/placebo for participants who permanently discontinued all study treatments. If the relevant baseline laboratory value is missing, then any abnormality of at least Grade 1 was considered treatment-emergent.|First dose date up to the last dose date (maximum: 161.7 weeks) plus 30 to 55 days|Participants in the Safety Analysis Set were analyzed.|||percentage of participants|||Number
2569253|NCT02545504|Secondary|Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal product, which does not necessarily have a causal relationship with the treatment. TEAEs are events in a given study period that meet any of the following criteria: Any AE with onset date of on or after andecalizimab/placebo start date and no later than 30 days after permanent discontinuation of all study treatment (andecaliximab/placebo and chemotherapy) or Any AEs with onset date of on or after the andecaliximab/placebo start date and no later than 55 days after permanent discontinuation of andecaliximab/placebo or AEs leading to discontinuation of andecaliximab/placebo.|First dose date up to the last dose date (maximum:161.7 weeks) plus 30 to 55 days|The Safety Analysis Set included all participants who received at least one dose of andecaliximab/placebo.|||percentage of participants|||Number
2569254|NCT02545504|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. CR was defined as the disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Up to 135.4 weeks at the time of final analysis|Participants in the ITT Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2569255|NCT02545504|Secondary|Progression-free Survival (PFS)|PFS was defined as the interval of time from the date of randomization to the earlier of the first documentation of definitive disease progression or death from any cause.|Andecaliximab + mFOLFOX6 median follow-up at the time of the final analysis: 18.64 months; Placebo + mFOLFOX6 median follow-up at the time of the final analysis: 18.74 months|Participants in the ITT Analysis Set were analyzed.|||months||95% Confidence Interval|Median
2569256|NCT02545504|Primary|Overall Survival (OS)|OS was defined as the time interval from the date of randomization to death from any cause.|Andecaliximab + mFOLFOX6 median follow-up at the time of final analysis: 19.43 months; Placebo + mFOLFOX6 median follow-up at the time of the final analysis: 19.45 months|The Intent-to-Treat (ITT) Analysis Set included all randomized participants.|||months||95% Confidence Interval|Median
2569257|NCT02545322|Secondary|Volumetric Changes|"Percent changes in the volume of the Planning Target Volume (PTV). The Planning Target Volume is a volume, consisting of the clinical target volume and additional safety margins, that should receive a certain radiation dose. The volumetric changes of the PTV throughout the course of Radiation therapy are evaluated. A significant change in the volume of the PTV (measured in ccm) might be an indicator for possible undesireable dosimetric alterations."|week 5||||percent||Standard Deviation|Mean
2569258|NCT02545322|Primary|Planning Target Volume (PTV) Coverage Parameter D98%|"Dose coverage of the planning target volume: Number of participants with a decrease in the planning target volume (PTV) coverage (D98%) above 5%. The Parameter D98% denotes the minimum dose to 98% of the volume according to the ICRU (International Commission on Radiation Units & Measurements) Report No. 62. It is a widely accepted classification index for dose coverage.~The Planing Target Volume is a volume, consisting of the clinical target volume and additional safety margins, that should receive a certain radiation dose."|week 5||||participants|||Number
2569259|NCT02545270|Secondary|Intra-rater Agreement of Both Rating Scales.|"To assess the intra-rater agreement of both rating scales, 10-point numerical and 5-point categorical scale.~The intra-rater agreement will be calculated using intraclass correlation statistics."|60 min|Intra-rater agreement of both scales ( 5-poit categorical and 10-point numerical) used to assess the 24 videos recorded from 13 participants.|||ICC||95% Confidence Interval|Number
2569260|NCT02545270|Secondary|Agreement Between the Two Rating Scales Will be Tested With Regression Analysis Using Spearman Correlation Coefficient|The agreement between the two rating scales 5-point categorical and 10-point numerical will be tested with regression analysis using Spearman correlation coefficient|60 min|Agreement between the two rating scales ( 5-poit categorical and 10-point numerical) used to assess the 24 videos recorded from 13 participants.|||Spearman correlation coefficient|Scales|95% Confidence Interval|Number
2569261|NCT02545270|Secondary|Inter-rater Agreement, 10-point Scale|"To validate a 10-point rating scale by investigating the inter-rater agreement of evaluations of the surgical workspace at different intra-abdominal pressures. The inter-rater agreement will be calculated using intraclass correlation statistics with statistical software.~The 10-point rating scale was a discrete numerical scale with 1 being worst possible surgical workspace and 10 being best possible."|60 min|The 24 videos recorded from 13 participants.|||ICC|Videos|95% Confidence Interval|Number
2569342|NCT02544074|Secondary|eSAGE Score Compared to the Mini-Mental State Examination (MMSE) Score|The investigators will compare the eSAGE scores with the Mini-Mental State Examination (MMSE) scores. Associations will be investigated using Spearman correlations.|3 hours||||spearman rank correlation|||Number
2569262|NCT02545270|Primary|Inter-rater Agreement, 5-point Scale|"To validate a 5-point rating scale by investigating the inter-rater agreement of evaluations of the surgical workspace at different intra-abdominal pressures.~The 5-point surgical rating scale is categorical, with following descriptions: 1 (Extremely poor conditions) Unable to complete surgery without interventions 2 (Poor conditions) Several minor adjustments needed to complete surgery. (e.g. changes in patient body position, surgeon position) 3 (Acceptable conditions) After few minor adjustments surgery can be completed. 4 (Good conditions) Surgical workspace is good, but there is some interference, but no need for adjustments.~5 (Optimal conditions) Surgical workspace is optimal and procedure can be completed without any interference.~Using intra-abdominal video recordings. The inter-rater agreement will be calculated using intraclass correlation statistics with statistical software."|60 min|The 24 videos recorded from 13 participants.|||ICC|Videos|95% Confidence Interval|Number
2569263|NCT02545101|Other Pre-specified|Prior Treatments Before Tolvaptan (Number and Percentage of Subjects Taking Prior Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification)|Only medications taken by more than 5% of the study population are presented|From 12 months up to baseline (tolvaptan treatment initiation)||||Participants|||Count of Participants
2569264|NCT02545101|Secondary|Average Treatment Duration for the Episode of Hyponatraemia Being Captured in the Study|"Average treatment duration for the episode of hyponatraemia secondary to SIADH being captured in the study by evaluation of dosing information (and dates) from the patient's medical records (up to 6 weeks after the initiation of tolvaptan treatment).~For these outcome measures, only days on treatment were considered (e.g. if tolvaptan treatment was interrupted and resumed afterwards, the days withot treatment were not considered)."|From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards||||days||Standard Deviation|Mean
2569265|NCT02545101|Secondary|Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia|symptoms associated with hyponatraemia by evaluation of symptomatology information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records|Baseline||||Participants|||Count of Participants
2569266|NCT02545101|Post-Hoc|Time (Days) to Hospital Discharge up to 6 Weeks After Treatment Start||From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards|"Originally, the idea was to analyse this out come in hours, but due to missing data, it was also analysed in days."|||days||95% Confidence Interval|Median
2569267|NCT02545101|Other Pre-specified|Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification)|Only medications taken by more than 5% of the study population are presented|From baseline (tolvaptan treatment initiation) up to 6 weeks after treatment initiation||||Participants|||Count of Participants
2569268|NCT02545101|Secondary|Time (Days) to Sodium Normalisation|Time (days) to sodium normalisation, defined as a serum sodium level > 135 mmol/L, by evaluation of serum sodium levels in relation to the episode of hyponatraemia secondary to SIADH being captured in the study (up to 6 weeks after treatment initiation).|From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards||||days||95% Confidence Interval|Median
2569269|NCT02545101|Secondary|Average Daily Dose of Tolvaptan Used and Treatment Duration (Expressed in Days) for the Episode of Hyponatraemia Being Captured in the Study|"Average daily dose of tolvaptan used and treatment duration (expressed in days) for the episode of hyponatraemia secondary to SIADH being captured in the study by evaluation of dosing information (and dates) from the patient's medical records (up to 6 weeks after the initiation of tolvaptan treatment).~For these outcome measures, only days on treatment were considered (e.g. if tolvaptan treatment was interrupted and resumed afterwards, the days withot treatment were not considered)."|From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards||||mg||Standard Deviation|Mean
2569270|NCT02545101|Secondary|Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,)|specialty of the clinician prescribing tolvaptan by evaluation of details of the physician who prescribed tolvaptan for the episode of hyponatraemia being captured in the study from the patient's medical records|Baseline||||% of participants|||Number
2569271|NCT02545101|Secondary|Symptoms Associated With Hyponatraemia (Number of Symptomatic/Asymptomatic Patients in the Study Population)|symptoms associated with hyponatraemia by evaluation of symptomatology information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records|Baseline||||Participants|||Count of Participants
2569272|NCT02545101|Secondary|Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,)|Primary disease diagnoses leading to SIADH by evaluation of diagnosis information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records|Baseline||||% of participants|||Number
2569273|NCT02545101|Secondary|Time (Hours) to Sodium Normalisation|Time (hours) to sodium normalisation, defined as a serum sodium level > 135 mmol/L, by evaluation of serum sodium levels in relation to the episode of hyponatraemia secondary to SIADH being captured in the study (up to 6 weeks after treatment initiation).|From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards|"Exact time was available for 64 patients, so the analysis in hours had a n=64"|||hours||95% Confidence Interval|Median
2569274|NCT02545101|Secondary|Change in Sodium Levels 6 Weeks After Treatment Initiation|Change in sodium level from last value prior to receiving tolvaptan until last available measurement up to week 6|From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards|only patients with a value at both baseline and that time point are included in the change|||mmol/L||Standard Deviation|Mean
2569275|NCT02545101|Secondary|Change in Sodium Levels 24 Hours After Treatment Initiation|Change in sodium level from last value prior to receiving tolvaptan until last available measurement within 24 hours of initiation of tolvaptan|From Baseline (treatment initiation with tolvaptan) up to 24 hours afterwards|Only patients with a value at both baseline and 24 hours of initiation of tovaptan were included in the change from baseline|||mmol/L||Standard Deviation|Mean
2569276|NCT02545101|Primary|Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge|The primary variable of the study was the change in sodium levels from baseline to discharge or the final available measurement for patients who were not discharged (up to 6 weeks after treatment initiation).|From Baseline Up to discharge (or a maximum of 6 weeks after start of treatment)|Baseline sodium level was not available for 4 patients|||mmol/L||Standard Deviation|Mean
2569277|NCT02544984|Other Pre-specified|Level of Cytokines|Using a standardize nasal wash procedure, respiratory samples will be collected at enrollment, at end of study, and during acute respiratory illness requiring face-to-face provider interaction. Children with a tracheostomy will have both a nasal wash sample and a tracheal aspirate sample collected. The respiratory samples will be stabilized with a universal transport media, processed and stored at -80 C for future testing. Testing will be performed for cytokines/chemokines; other biomarkers of disease such as LDH, MPO, and caspase; viral and bacterial respiratory pathogens; and microbiome.|8 months|||||||
2569278|NCT02544984|Other Pre-specified|Level of Airway Conductance|To determine if prophylactic use of azithromycin will reduce level of airway resistance as measured by an Airwave Oscillometry System in subjects above 2 years of age, at the time of respiratory illnesses, during the 3-6 months intervention.|6 months|||||||
2569279|NCT02544984|Other Pre-specified|Long Term Reduction in Respiratory Symptoms|To determine if prophylactic use of azithromycin will reduce the total number of unscheduled face-to-face physician visit for respiratory related illness in a clinic, urgent care, emergency room or hospital setting during the following 12 months after the intervention.|12 months|||||||
2569280|NCT02544984|Secondary|Healthcare Cost Associated With Respiratory Illness|Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time during the end of the winter season, which accounts for the variability in the amount of time participants were observed.|5 to 8 months|Cost-effective analyses are only justified for interventions that are shown to be effective. Because the intervention at study (the macrolide azithromycin) showed no benefit and led to worse outcomes than those with usual care, an economic evaluation is not warranted and claims data was not collected.||||||
2569281|NCT02544984|Secondary|Number of Adverse Events|Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time at the end of the winter season, which accounts for the variability in the amount of time participants were observed.|5 to 8 months||||adverse events|||Number
2569282|NCT02544984|Primary|Number of Unscheduled Face-to-face Physician Visits (Clinic Visits, ER Visits, and Hospitalizations)|Participants were observed for a minimum of 5 months and a maximum of 8 months, depending on when study enrollment occurred. Patients were recruited for this study on a rolling basis during the start of the winter season and then completed the intervention at the same time at the end of the winter season, which accounts for the variability in the amount of time participants were observed.|5 to 8 months||||visits|||Number
2569283|NCT02544633|Secondary|Blood Plasma Concentration of Soluble MET (sMET) Biomarker|MET Activating Mutations in ctDNA. Change from Baseline - Cycle 2 Day 15 - Pre-Dose Standard Deviation not evaluable|Cycle 1 and Cycle 2|The Pharmacodynamics Evaluable Population Population defined as all patients in the mITT population for whom PD analytical results were available. Overall number of participants analyzed at baseline and post-baseline are different due to samples not being collected post-baseline for some patients.|||pg/mL||Standard Deviation|Mean
2569284|NCT02544633|Secondary|Assess Change in Genetic Alteration Status in ctDNA With MGCD265 Treatment Over Time in the Selected Population||At baseline and at time of confirmation of response to treatment|The study was closed early due to sponsor portfolio prioritization and not due to any patient safety issues. Based on limited individual patient data for whom baseline and post-treatment values were available, the statistical analyses as planned could not be performed. Screening and end of treatment detection results provided.|||participants|||Number
2569285|NCT02544633|Secondary|Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Gene Amplifications|Only a sub-set of patients had different molecular techniques completed, therefore a correlation analysis was not performed. Patients with positive identification by two different analytical techniques are tabulated for MET Gene Amplifications.|At baseline||||Participants|||Count of Participants
2569286|NCT02544633|Secondary|Assess Correlation Between Selected Tumor Gene Alterations Using Different Analytical Techniques in Tumor Tissue and Circulating Tumor Deoxyribonucleic Acid (ctDNA) - MET Activating Mutations|Only a sub-set of patients had different molecular techniques completed, therefore a correlation analysis was not performed. Patients with positive identification by two different analytical techniques are tabulated for MET Activating Mutations.|At baseline||||Participants|||Count of Participants
2569287|NCT02544633|Secondary|Blood Plasma Concentration of MGCD265 - Tmax|Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Note: Assessment of Cmax and Tmax are limited by the sparse blood sampling schedule post dose (i.e., only 2 blood draws post-dose in Cycle 1 and only 1 sample collected post-dose in Cycle 2). The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose.|Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.|PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.|||hours||Full Range|Median
2569288|NCT02544633|Secondary|Blood Plasma Concentration of MGCD265 - Peak to Trough Ratio|Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose. Peak to trough ratio calculated as C1D15 Cmax/Ctrough.|Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.|PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2569316|NCT02544451|Secondary|Absolute Change in BMI-for-age Z-score|BMI was defined as weight in kilograms divided by height in m^2. z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean.|From Parent Study Baseline at Week 96|FAS.|||z-score||95% Confidence Interval|Least Squares Mean
2569354|NCT02543801|Secondary|Length of Stay|Measured in hours|Start of surgery to hospital discharge up to 140 hours||||Hours||Standard Deviation|Mean
2569289|NCT02544633|Secondary|Blood Plasma Concentration of MGCD265 - Accumulation Ratio Cmax|Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose. Accumulation Ration Cmax = Cmax C1D15/ Cmax C1D1.|Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.|PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2569290|NCT02544633|Secondary|Blood Plasma Concentration of MGCD265 - Accumulation Ratio AUC0-6|Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose. Accumulation Ratio AUC0-6 = AUC0-6 C1D15/ AUC0-6 C1D1.|Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.|PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2569291|NCT02544633|Secondary|Blood Plasma Concentration of MGCD265 - Ctrough|Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. On Cycle 2, samples were collected on Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours). The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose.|Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Cycle 2, Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours).|PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters. No results are reported for C2D15 because the number of observations were less than 3 for the 1050 mg BID (Soft Gel Capsule).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2569292|NCT02544633|Secondary|Blood Plasma Concentration of MGCD265 - Cmax|Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. On Cycle 2, samples were collected on Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours). Note: Assessment of Cmax and Tmax are limited by the sparse blood sampling schedule post dose (i.e., only 2 blood draws post-dose in Cycle 1 and only 1 sample collected post-dose in Cycle 2). The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose.|Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. Cycle 2, Day 1 and Day 15 at pre-dose and at 6 hours post-dose (4-8 hours).|PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters. No results are reported for C2D15 because the number of observations were less than 3 for the 1050 mg BID (Soft Gel Capsule).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2569293|NCT02544633|Secondary|Blood Plasma Concentration of MGCD265 - AUC0-6|Blood samples for PK assessment were to be taken on Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose. The number of patients reported for each PK parameter was dependent on the actual number of blood samples collected post-dose.|Cycle 1, Day 1 and Day 15 at pre-dose and at 2 hours (1-3 hours) and 6 hours (4-8 hours) post-dose.|PK Analysis Set consisted of all patients who received at least one dose of active study drug and had sufficient data to assess any of the PK parameters.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2569294|NCT02544633|Secondary|Number of Patients Experiencing Treatment-emergent Adverse Events|Number of patients experiencing treatment-emergent adverse events.|Date of first dose to 28 days after the last dose, up to an average of 5.1 months on treatment.|Safety population|||Participants|||Count of Participants
2569295|NCT02544633|Secondary|Overall Survival|Overall Survival will be defined as the time from date of first study treatment to death due to any cause|From date of first study treatment to death due to any cause, assessed up to 24 months.|Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265|||months||95% Confidence Interval|Median
2569296|NCT02544633|Secondary|1-Year Survival Rate|1-Year Survival will be defined as the probability of survival at 1 year after the first dose.|From date of first study treatment to death due to any cause, assessed up to 12 months|Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265|||percentage||95% Confidence Interval|Number
2569297|NCT02544633|Secondary|Progression Free Survival|Progression-free survival (PFS) will be defined as the time from date of first study treatment to first PD or death due to any cause in the absence of documented PD. Per RECIST 1.1, Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy) with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions.|The time from date of first study treatment to first PD or death due to any cause in the absence of documented PD, up to 24 months.|Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265|||months||95% Confidence Interval|Median
2569298|NCT02544633|Secondary|Duration of Response|Duration of Response (DR) will be defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of Objective Progression of Disease (PD) or to death due to any cause in the absence of documented PD.|From date of the first documentation of objective tumor response (CR or PR) to the first documentation of Objective Progression of Disease (PD) or to death due to any cause in the absence of documented PD, assessed up to 24 months.|Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265|||days||95% Confidence Interval|Median
2569317|NCT02544451|Secondary|Relative Change in ppFEV1|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|From Parent Study Baseline at Week 96|FAS.|||percent change||95% Confidence Interval|Least Squares Mean
2569318|NCT02544451|Secondary|Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|From Parent Study Baseline at Week 96|FAS.|||percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
2569299|NCT02544633|Primary|Objective Response Rate|Objective disease response is defined as the percent of patients documented by investigator assessment to have a confirmed Complete Response (CR) or Partial Response (PR) in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for target and non-target lesions as assessed by CT or MRI. CR is defined as complete disappearance of all target lesions with the exception of nodal disease; PR is defined as >=30% decrease under baseline of the sum of diameters of all target measurable lesions; Stable Disease (SD) is concluded when the response does not qualify for CR, PR or Progression; Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions.|Up to 3 months|Modified Intent-to-Treat (mITT) Population defined as all patients who received at least one dose of MGCD265|||percentage of participants||95% Confidence Interval|Number
2569300|NCT02544607|Secondary|Percent Change in Tissue Fractional Anisotropy Quantification (Right Uncinate Fasciculus)|Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion|4 hours|Reasons for missing data (N=3) included a scanner malfunction and participant requests to stop scanning prior to dMRI sequence acquisition.|||percent change|||Number
2569301|NCT02544607|Secondary|Percent Change in Tissue Fractional Anisotropy Quantification (Left Superior Longitudinal Fasciculus)|Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion|4 hours|Reasons for missing data (N=3) included a scanner malfunction and participant requests to stop scanning prior to dMRI sequence acquisition.|||percent change|||Number
2569302|NCT02544607|Secondary|Percent Change in Tissue Fractional Anisotropy Quantification (Right Inferior Longitudinal Fasciculus)|Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion|4 hours|Reasons for missing data (N=3) included a scanner malfunction and participant requests to stop scanning prior to dMRI sequence acquisition.|||percent change|||Number
2569303|NCT02544607|Secondary|Percent Change in Tissue Fractional Anisotropy Quantification (Left Inferior Longitudinal Fasciculus)|Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion|4 hours|Reasons for missing data (N=3) included a scanner malfunction and participant requests to stop scanning prior to dMRI sequence acquisition.|||percent change|||Number
2569304|NCT02544607|Primary|Change in Hamilton Depression Rating Scale (HDRS) From Baseline/Minute 0 to 4 Hours Post-infusion.|"Hamilton Depression Rating Scale; possible scores range from 0 to 81 with higher scores indicating higher depression symptoms~Change will be calculated by difference between HDRS from Minute 0 to Minute 240."|4 hours||||score on a scale||Full Range|Mean
2569305|NCT02544451|Secondary|Rate of Change in ppFEV1|Rate of change analysis evaluates the change in ppFEV1 after long term treatment with LUM/IVA. A rate of change equal to zero would indicate that treatment effects were stable.|Day 15 after first dose of LUM/IVA through Week 96|As pre-specified in the SAP, this analysis was conducted in the LUM/IVA Overall group because of sample size. Analysis period is 15 days after first dose of LUM/IVA in parent study or current study (if assigned to placebo in study 109) through the end of current study.|||slope||95% Confidence Interval|Number
2569306|NCT02544451|Secondary|Rate of Change in LCI 5.0|Rate of change analysis evaluates the change in LCI 5.0 after long term treatment with LUM/IVA. A rate of change equal to zero would indicate that treatment effects were stable.|Day 15 after first dose of LUM/IVA through Week 96|As pre-specified in the SAP, this analysis was conducted in the LUM/IVA Overall group because of sample size. Analysis period is 15 days after first dose of LUM/IVA in parent study or current study (if assigned to placebo in study 109) through the end of current study.|||slope||95% Confidence Interval|Number
2569307|NCT02544451|Secondary|Rate of Change in LCI 2.5|Rate of change analysis evaluates the change in LCI 2.5 after long term treatment with LUM/IVA. A rate of change equal to zero would indicate that treatment effects were stable.|Day 15 after first dose of LUM/IVA through Week 96|As pre-specified in the SAP, this analysis was conducted in the LUM/IVA Overall group because of sample size. Analysis period is 15 days after first dose of LUM/IVA in parent study or current study (if assigned to placebo in study 109) through the end of current study.|||slope||95% Confidence Interval|Number
2569308|NCT02544451|Secondary|Number of Pulmonary Exacerbation Events Per Patient-year|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.|From Parent Study Baseline through Week 96|Analysis included all participants dosed in parent study 109. LUM/IVA to LUM/IVA analysis period includes both parent study and current study. PBO to LUM/IVA analysis period includes the current study only.|||events per patient-year||95% Confidence Interval|Number
2569309|NCT02544451|Secondary|Percentage of Participants Having At Least 1 Pulmonary Exacerbation Event|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.|From Parent Study Baseline through Week 96|Analysis included all participants dosed in parent study 109. LUM/IVA to LUM/IVA analysis period includes both parent study and current study. PBO to LUM/IVA analysis period includes the current study only.|||percentage of participants|||Number
2569310|NCT02544451|Secondary|Time-to-first Pulmonary Exacerbation|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.|From Parent Study Baseline through Week 96|Analysis included all participants dosed in parent study 109. LUM/IVA to LUM/IVA analysis period includes both parent study and current study. PBO to LUM/IVA analysis period includes the current study only.|||days||Inter-Quartile Range|Median
2569311|NCT02544451|Secondary|Absolute Change in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Domain Score|The TSQM measures participants' experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed in the total domain score, which ranges from 0 to 100, where higher scores indicate greater satisfaction.|From Parent Study Baseline at Week 96|FAS.|||units on a scale||95% Confidence Interval|Least Squares Mean
2569319|NCT02544451|Secondary|Absolute Change in LCI 5.0|LCI 5.0 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/20th of its starting value.|From Parent Study Baseline at Week 96|LCI set.|||lung clearance index||95% Confidence Interval|Least Squares Mean
2569321|NCT02544451|Secondary|Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|From Parent Study Baseline at Week 96|FAS.|||units on a scale||95% Confidence Interval|Least Squares Mean
2569322|NCT02544451|Secondary|Absolute Change in Body Mass Index (BMI)|BMI was defined as weight in kilograms divided by height in square meter (m^2).|From Parent Study Baseline at Week 96|FAS.|||kg/m^2||95% Confidence Interval|Least Squares Mean
2569323|NCT02544451|Secondary|Absolute Change in Sweat Chloride|Sweat samples were collected using an approved collection device.|From Parent Study Baseline at Week 96|Full Analysis Set (FAS) includes all participants enrolled and dosed in either parent study. Analysis period includes both parent study and current study.|||millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2569324|NCT02544451|Secondary|Absolute Change in Lung Clearance Index (LCI) 2.5|LCI 2.5 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting value.|From Parent Study Baseline at Week 96|LCI set includes all participants enrolled and dosed in either parent study 109 or 011B LCI sub-study. Analysis period includes both parent study and current study.|||lung clearance index||95% Confidence Interval|Least Squares Mean
2569325|NCT02544451|Primary|Treatment Cohort: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)||Day 1 up to Week 100|Safety set included all participants who received at least 1 dose of study drug.|||participants|||Number
2569326|NCT02544152|Secondary|Number of Participants Classified as an Overall Responder for IBS Symptoms|A participant who is a weekly responder for IBS symptoms for at least 75% of observed treatment weeks is classified as an overall responder for IBS symptoms.|within 3 months|mITT|||Participants|||Count of Participants
2569327|NCT02544152|Secondary|Number of Participants Classified as a Monthly Responder for IBS Symptoms|A participant who is a weekly responder for IBS symptoms for at least 2 of the 4 weeks in the preceding month is classified as a monthly responder for IBS symptoms.|within 3 months|mITT|||Participants|||Count of Participants
2569328|NCT02544152|Secondary|Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms|A participant who achieves adequate relief of IBS symptoms during the preceding week is classified as a weekly responder for IBS symptoms.|within 12 weeks|mITT|||Participants|||Count of Participants
2569329|NCT02544152|Secondary|Number of Participants Classified as an Overall Responder for Stool Consistency|An overall responder for stool consistency is defined as a participant who qualifies as a weekly responder for stool consistency for at least 75% of observed treatment weeks.|within 3 months|mITT|||Participants|||Count of Participants
2569330|NCT02544152|Secondary|Number of Participants Classified as a Monthly Responder for Stool Consistency|A monthly responder for stool consistency is defined as a participant who is a weekly responder for stool consistency at least 2 of 4 weeks in the preceding month.|within 3 months|mITT|||Participants|||Count of Participants
2569331|NCT02544152|Secondary|Number of Participants Classified as a Weekly Responder for Stool Consistency|A weekly responder for stool consistency is defined as a participant having at least 50% reduction from baseline in percentage of days with extreme stool consistency for a given week.|within 12 weeks|mITT|||Participants|||Count of Participants
2569332|NCT02544152|Secondary|Number of Participants Classified as a Monthly Responder for Abdominal Pain|A monthly responder for abdominal pain is defined as a participant who is a weekly responder for abdominal pain at least 2 of 4 weeks in the preceding month.|within 3 months|mITT|||Participants|||Count of Participants
2569333|NCT02544152|Secondary|Number of Participants Classified as a Weekly Responder for Abdominal Pain|"Participants rate their pain on a pain intensity scale where 0=no pain and 10=worst pain. A higher score means the pain is worse.~A weekly responder for abdominal pain is defined as a participant reporting ≥ 30% reduction from baseline in average of 24-hour worst abdominal pain scores for the preceding week."|within 12 weeks|mITT|||Participants|||Count of Participants
2569334|NCT02544152|Primary|Number of Participants Classified as an Overall Responder for Abdominal Pain|An overall responder for abdominal pain is defined as a participant who is a weekly responder for at least 75% of observed treatment weeks.|within 12 weeks|modified Intent to Treat (mITT), defined as all randomized subjects who take at least one dose of study medication.|||Participants|||Count of Participants
2569335|NCT02544074|Secondary|eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Block Design Score|The investigators will compare the eSAGE scores to the WAIS III Block Design scores. The WAIS III Block Design requires the replication of red and white designs using three-dimensional colored blocks. Associations will be investigated using Spearman correlations.|3 hours||||spearman rank correlation|||Number
2569336|NCT02544074|Secondary|eSAGE Score Compared to the Wechsler Adult Intelligence Scale III (WAIS III) Letter-number Score|The investigators will compare the eSAGE scores to the WAIS III Letter-number scores. The WAIS III Letter-number test asks subjects to recall a series of numbers in increasing order and letters in alphabetical order. Associations will be investigated using Spearman correlations.|3 hours||||spearman rank correlation|||Number
2569337|NCT02544074|Secondary|eSAGE Score Compare to the FAS Verbal Fluency Task Score|The investigators will compare the eSAGE scores to the FAS Verbal Fluency Task scores. Associations will be investigated using Spearman correlations.|3 hours||||spearman rank correlation|||Number
2569338|NCT02544074|Secondary|eSAGE Score Compared to the Hopkins Verbal Learning Test (HVLT) Score|The investigators will compare the eSAGE scores to the Hopkins Verbal Learning Test (HVLT) total learning scores. Associations will be investigated using Spearman correlations. The investigators will also compare the eSAGE scores to the Hopkins Verbal Learning Test (HVLT) delayed recall scores. Associations will be investigated using Spearman correlations.|3 hours||||spearman rank correlation|||Number
2569339|NCT02544074|Secondary|eSAGE Score Compared to the Wisconsin Card Sort Task (WCST) Score|The investigators will compare the eSAGE scores to the Wisconsin Card Sort Task (WCST) perseverative errors scores. Associations will be investigated using Spearman correlations.|3 hours||||spearman rank correlation|||Number
2569343|NCT02544074|Secondary|eSAGE Score Compared to the Paper SAGE Score|The investigators will compare the subject's scores on the SAGE in digital format to their paper SAGE scores to determine if these two formats are equivalent to each other. Associations will be investigated using Spearman correlations.|3 hours||||spearman rank correlation|||Number
2569344|NCT02544074|Primary|eSAGE Score Compared to the Sum of the Neuropsychological Measures.|"Analysis will consist of comparing the subject's scores on the SAGE in digital format to their neuropsychological test scores. This will be a composite score of the neuropsychological testing scores. The neuropsychological measures include:~Boston Naming Test~Wisconsin Card Sort Task (WCST)~Hopkins Verbal Learning Test (HVLT)~FAS verbal fluency task~Wechsler Adult Intelligence Scale III (WAIS III) Letter-number and block design subtests~Associations will be investigated using Spearman correlations."|3 Hours||||spearman rank correlation|||Number
2569345|NCT02543918|Primary|Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations|"Responder to tetanus vaccine defined as a post-vaccination anti-tetanus antibody concentration of >=1.0 (International Unit (IU) and a >=1.5-fold increase (50% increase) from baseline if the pre-vaccination concentration is <=1.0 at baseline OR a >=2.5-fold increase (150% increase) from baseline if the pre-vaccination concentration is > 1.0 IU at baseline.~Responder to the pneumococcal vaccine is defined as a >=2-fold increase (100% increase) from baseline in anti-pneumococcal antibody concentrations against >50% of the 23 serotypes."|Week 6|All randomized participants who completed the study.|||percentage of participants|||Number
2569346|NCT02543892|Primary|Number of Adverse Events (AE), by Relation to Vaccine and Seriousness|Only treatment-emergent adverse events (TEAEs) were included in the analysis; adverse events (AEs) that were not TEAEs were to have been listed.|112 days||||adverse events|||Number
2569347|NCT02543892|Secondary|Number of Subjects With Immunoglobulin G (IgG) Seroresponse|Between baseline and 28 days after vaccination 2. Proteins were measured on the Meso Scale Discovery (MSD) platform using an an electrochemiluminescence detection assay.|Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112)||||Participants|||Count of Participants
2569348|NCT02543892|Secondary|Immunoglobulin G (IgG) Antibody Geometric Mean Fold Change Against Pneumococcal Proteins|Between baseline and 28 days after vaccination 2. Proteins were measured on the Meso Scale Discovery (MSD) platform using an an electrochemiluminescence detection assay.|Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112)||||fold change||95% Confidence Interval|Geometric Mean
2569349|NCT02543892|Secondary|Immunoglobulin G (IgG) Antibody Geometric Mean Concentration Against Pneumococcal Proteins|Proteins were measured on the Meso Scale Discovery (MSD) platform using an an electrochemiluminescence detection assay. Units were arbitrary.|Baseline and 12 weeks after vaccination 2 (Day 0 and Day 112)||||arbitrary units||95% Confidence Interval|Geometric Mean
2569350|NCT02543892|Primary|Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 2|Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, axillary fever/temperature, drowsiness, irritability, and decreased appetite. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the PI for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. Grade 0 is equivalent to no event.|7 days after the second dose (Day 35)||||Participants|||Count of Participants
2569351|NCT02543892|Primary|Highest Grade of Reactogenicity Events in the Toddler Cohort: Vaccination 1|Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, axillary fever/temperature, drowsiness, irritability, and decreased appetite. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the PI for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. Grade 0 is equivalent to no event.|7 days after the first dose (Day 7)||||Participants|||Count of Participants
2569352|NCT02543892|Primary|Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 2|Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, headache, axillary fever/temperature, fatigue/malaise, and arthralgia/myalgia. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the principal investigator (PI) for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity.|7 days after the second dose (Day 35)||||Participants|||Count of Participants
2569353|NCT02543892|Primary|Highest Grade of Reactogenicity Events in the Adult Cohort: Vaccination 1|Solicited adverse events (AEs) were referred to as reactogenicity events (REs). Local REs included pain, induration/swelling, and erythema/redness at the injection site for adults; and pain/tenderness, redness, and induration/swelling for toddlers. Solicited systemic REs included cutaneous rash, headache, axillary fever/temperature, fatigue/malaise, and arthralgia/myalgia. Solicited REs were assessed for all subjects during the 60 minutes post-vaccination, daily for the first week, and at the clinic visit 1 week post-vaccination. Within the first week post-vaccination, fieldworkers visited the subject at home daily to assess and record solicited reactogenicity and determine whether the subject needed to be seen by the principal investigator (PI) for any medical condition or issue. Generally, grade 1 was no interference with activity, grade 2 was some interference with activity, and grade 3 was prevents daily activity. Grade 0 is equivalent to no event.|7 days after the first dose (Day 7)||||Participants|||Count of Participants
2569356|NCT02543801|Primary|Pain Score|"Self-reported pain score 0-10 (0=no pain - 10=worst possible pain experienced) and higher scores indicate a worse outcome~Pain scores, collected every 4 hours per hospital care standards, were averaged (post-operatively up to 48 hours) to obtain individual mean pain scores and a mean score for the group was then calculated."|Starting post operatively and then every four hours up to 48 hours||||score on a scale||Standard Deviation|Mean
2569357|NCT02543554|Secondary|Number of Patients That Die During the Hospitalization||Patients will be followed for the duration of hospital stay||||participants|||Number
2569358|NCT02543554|Primary|Number of Patients That Experience Pulmonary Complications After Admission From the Emergency Department||7 days||||participants|||Number
2569359|NCT02543528|Secondary|Overall Vision Score|Overall quality of vision score was assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). CLUE was collected at the 1-day, 5-day, 12-day, 26-day, 88-day and 180-day follow-up evaluation.|Time Frame Up to 6 months|The analysis population consists of all subjects that have completed all study visits without a major protocol deviation in both the adaptation and extended wear periods.|||Units on a Scale||Standard Deviation|Mean
2569360|NCT02543528|Secondary|Overall Comfort Score|Overall comfort was assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD). CLUE was collected at the 1-day, 5-day, 12-day, 26-day, 88-day and 180-day follow-up evaluation.|Time Frame Up to 6 months|The analysis population consists of all subjects that have completed all study visits without a major protocol deviation in both the adaptation and extended wear periods.|||Units on a Scale||Standard Deviation|Mean
2569361|NCT02543528|Primary|Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE)|The number of first serious and significant corneal infiltrative adverse events deemed to be related to contact lens wear (possible, probable or very likely) during a 6-month period (contact lens extended wear period) was assessed via Biomicroscopy. A biomicroscope was used to detect the presence of a corneal infiltrate for each subject eye (Yes: corneal infiltrates detected, No: None present). The number of subjects with corneal infiltrative events was reported for each lens type.|Up to 6 months|The analysis population consists of all subjects that were enrolled into the extended wear period.|||Number of Events|Eyes||Number
2569362|NCT02543437|Secondary|Wear Rate(%)|Retrospective comparison of the wear amount over time between X3 liner and Crossfire insert.|1 year, 2 years, 3 years and 5 years after surgery|||||||
2569363|NCT02543437|Primary|Lift Off Distance in Dislocation Maneuver(mm)|Measure and compare the lift off distance in dislocation maneuver using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.|Intraoperative|participants with available data : 100 hips in 100 participants.|||mm|Hips|Standard Deviation|Mean
2569364|NCT02543437|Primary|Range of Motion(ROM) (Degree)|Measure and compare the ROM using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.|Intraoperative|Comparison between 28mm liner and 36mm line. Participants with available data : 119 hips in 117 participants.|||Degree|Hips|Standard Deviation|Mean
2569365|NCT02543398|Primary|Radiographic Bone Changes|The width and the height of the alveolar ridge will be measured (in mm) on the initial (i.e. following tooth extraction) Cone Beam CT and on the CBCT taken prior to implant placement (i.e. 3 months after tooth extraction)|3 months after tooth extraction||||millimeter||Standard Error|Mean
2569366|NCT02543346|Secondary|Comparison of VAS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.|"Participants recorded the severity of all nasal and ocular symptoms at baseline and at the end of both treatment visits.~The Visual Analogue Scale (VAS) is a single overall rating of the severity of all nasal and ocular symptoms experienced by the participant. The scale ranges from 0 to 100 mm with 0 mm being no symptoms and 100 mm being the worst symptoms the participant has ever felt."|First treatment visit and second treatment visit.|Efficacy analyses included all randomized participants who received at least 1 dose of study medication (Cetirizine 10 mg or Placebo).|||units on a scale||Standard Error|Mean
2569367|NCT02543346|Secondary|Comparison of GRCS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.|"Participants recorded how they were feeling at baseline and at the end of both treatment visits.~The Global Rating of Change Scale documents the changes in the participant's emotions. The scale ranges from +7 (A very great deal better) to -7 (A very great deal worse) with 0 being no change. A higher score indicates a better outcome."|First treatment visit and second treatment visit.|Efficacy analyses included all randomized participants who received at least 1 dose of study medication (Cetirizine 10 mg or Placebo).|||score on a scale||Standard Error|Mean
2569368|NCT02543346|Secondary|Comparison of TOSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.|"Participants recorded their nasal and ocular symptoms at baseline and during the intervention visits.~The Total Ocular Symptom Score (TOSS) is a composite score comprised of 3 ocular (itchy eyes, watery eyes, red/burning eyes) symptoms. The severity of each individual symptom is rated on a 4-point scale (0 to 3) and are summed for a maximum TOSS of 9 (0 to 9) .The 4-point scale includes a severity score of 0 (None: no sign/symptom is evident), 1 (Mild: Sign/symptom clearly present, but minimal awareness; easily tolerated), 2 (Moderate: Definite awareness of sign/symptom that is bothersome, but tolerable), 3 (Severe: Sign/symptom that is hard to tolerate; causes interference with activities during the challenge session. A higher score indicates higher symptom severity."|First treatment visit and second treatment visit.|Efficacy analyses included all randomized participants who received at least 1 dose of study medication (Cetirizine 10 mg or Placebo).|||score on a scale||Standard Error|Mean
2569458|NCT02542072|Secondary|Deterioration in Comfort|Deterioration of comfortable wearing time for habitual, comfilcon A, samfilcon A lenses. Subjects answered 'yes' or 'no' to the following question 'does contact lens comfort deteriorate during wear?'. Yes=deterioration in comfort present, No=deterioration in comfort absent|Baseline, 2 weeks, 4 weeks||||participants|||Number
2569369|NCT02543346|Secondary|Comparison of TNSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.|"Participants recorded their nasal and ocular symptoms at baseline and during the intervention visits.~The Total Nasal Symptom Score (TNSS) is a composite score comprised of 4 nasal (runny nose, sneezing, nasal itch, nasal congestion) symptoms. The severity of each individual symptom is rated on a 4-point scale (0 to 3) and are summed for a maximum TNSS of 12 (0 to 12) .The 4-point scale includes a severity score of 0 (None: no sign/symptom is evident), 1 (Mild: Sign/symptom clearly present, but minimal awareness; easily tolerated), 2 (Moderate: Definite awareness of sign/symptom that is bothersome, but tolerable), 3 (Severe: Sign/symptom that is hard to tolerate; causes interference with activities during the challenge session. A higher score indicates higher symptom severity."|First treatment visit and second treatment visit.|Efficacy analyses included all randomized participants who received at least 1 dose of study medication (Cetirizine 10 mg or Placebo).|||score on a scale||Standard Error|Mean
2569370|NCT02543346|Primary|Comparison of TRSS From Baseline Between the EEU and BRC in the Cetirizine 10 mg and Placebo Groups.|"Participants recorded their nasal and ocular symptoms at baseline and during the intervention visits.~The TRSS is a composite score comprised of 4 nasal (runny nose, sneezing, nasal itch, nasal congestion) and 3 ocular (itchy eyes, watery eyes, red/burning eyes) symptoms. The severity of each individual symptom is rated on a 4-point scale (0 to 3) and are summed for a maximum TRSS of 21 (0 to 21).The 4-point scale includes a severity score of 0 (None: no sign/symptom is evident), 1 (Mild: Sign/symptom clearly present, but minimal awareness; easily tolerated), 2 (Moderate: Definite awareness of sign/symptom that is bothersome, but tolerable), 3 (Severe: Sign/symptom that is hard to tolerate; causes interference with activities during the challenge session. A higher score indicates higher symptom severity."|First treatment visit and second treatment visit.|Efficacy analyses included all randomized participants who received at least 1 dose of study medication (Cetirizine 10 mg or Placebo).|||score on a scale||Standard Error|Mean
2569371|NCT02543294|Secondary|Risk Factors to Predict Early Decline of Myocardial Function During the Weaning of HF (Heart Failure) Medications.|To identify an increased troponin-I that can predict the possibility of HF medication withdrawal failure.|A total of 30 months from enrollment date of each participant|The standard deviation is 0 because every value collected over the course of the entire study was 0.03. Mean would be 0.03 with a standard deviation of 0|||ng/mL||Standard Deviation|Mean
2569372|NCT02543294|Primary|Determine the Percentage of Cancer Survivors That Maintain Left Ventricular Ejection Fraction (LVEF) ≥50% After Discontinuing Cardiac Medications: Beta Blockers, Angiotensin Converting Enzyme Inhibitors (ACE-I), or Angiotensin Receptor Blockers (ARB).|A withdrawal failure is defined as a decrease in the LVEF when cardiac medications are discontinued as determined by echocardiogram to LVEF<50% or a decrease by 10% from baseline measurement. Maintenance of LVEF is defined as LVEF≥50%. LVEF was assessed at Baseline, Months 2, 4, 6, 12, 18, & 30.|A total of 30 months from enrollment date of each participant;||||Participants|||Count of Participants
2569373|NCT02542943|Secondary|Change From Baseline in VRS of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 8|"Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (No Pain) to 10 (Intense Pain). A reduction in the score is indicative of an improvement in sensitivity."|Baseline, Week 8|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
2569374|NCT02542943|Secondary|Change From Baseline in Visual Rating Scale (VRS) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse) at Week 4|"Participants rated the intensity of their response to the evaporative (air) stimulus using a 10 point VRS. The Participants were asked to rate their pain on a scale of 1 (No Pain) to 10 (Intense Pain). A reduction in the score is indicative of an improvement in sensitivity."|Baseline, Week 4|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
2569375|NCT02542943|Secondary|Change From Baseline in Tactile Threshold (g) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 8|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.|Baseline, Week 8|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||g||Full Range|Median
2569376|NCT02542943|Secondary|Change From Baseline in Tactile Threshold (Gram [g]) of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force has reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g. However, in situations where participants did not give a 'yes' response at force of 80g, the tactile threshold was recorded as >80g. For analysis purposes values recorded as >80g were treated as 90g values.|Baseline, Week 4|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||g||Full Range|Median
2569459|NCT02542072|Secondary|Wearing Times|Average wear time and comfortable wearing times (WTs) in hours for habitual, comfilcon A, and samfilcon A lenses.|Baseline, 2 weeks, 4 weeks||||hours||Standard Deviation|Mean
2571691|NCT02513732|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|During hospitalization|ITT population|||Participants|||Count of Participants
2569377|NCT02542943|Secondary|Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 and a Placebo Oral Rinse at Week 4|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, Week 4|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
2569378|NCT02542943|Secondary|Change From Baseline in Schiff Sensitivity Score of Two Experimental Oral Rinses 1 and 2 at Week 8|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, Week 8|ITT population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
2569379|NCT02542943|Primary|Change From Baseline in Schiff Sensitivity Score of Experimental Oral Rinses 1 and 2 Against a Placebo Oral Rinse at Week 8|The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.|Baseline, Week 8|Intent-to-treat (ITT) population included all participants who were randomized, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||score on a scale||Standard Deviation|Mean
2569380|NCT02542865|Secondary|Change From Baseline in Energy Consumption at Month 9|Quantity of dietary intake was also measured by energy intake which was assessed from 24-h dietary recall survey. A structured interview was conducted based on a questionnaire. Parent/LARs (legally appropriate representative) provided the majority of information, with the child making additions to fill in the gaps. Parents/LARs recalled all food and beverage consumed by the child during previous 24-h and information such as list and amount of ingredients, cooking method and portion size was recorded. Calculation on energy, protein, carbohydrates and fat were made using Dietsoft software based on Indian data (NIN and ICMR) was used.|At baseline and month 9|mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.|||Kilocalories (Kcal)||Standard Deviation|Mean
2569381|NCT02542865|Secondary|Change From Baseline in Protein, Carbohydrates and Fat Consumption at Month 9|Quantity of dietary intake was measured by protein, carbohydrate, and fat intake which was assessed from 24h dietary recall form. A structured interview was conducted based on a questionnaire. Parent/LARs provided the majority of information, with the child/ participant making additions to fill in the gaps. Both participants and parents/LARs recalled all food and beverage consumed by the child during previous 24h and information such as list and amount of ingredients, cooking method and portion size was recorded. Calculation on energy, protein, carbohydrates and fat were made using Dietsoft software based on Indian data (NIN [National Institute of Nutrition] and ICMR [Indian Council of Medical Research]) was used.|At baseline and month 9|mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.|||Grams (g)||Standard Deviation|Mean
2569382|NCT02542865|Secondary|Change From Baseline in Individual Dietary Diversity Score (IDDS) at Month 9|IDDS-measure of nutritional quality of individual's diet-assessed by questionnaire based on Guidelines for measuring household and individual dietary diversity set by Food and Agriculture Organisation (FAO) of United Nations[FAO guidelines dietary diversity,2011].Based on data of foods and beverages consumed in last 24h as captured by 24h dietary survey,appropriate food groups were selected. IDDS was calculated by adding number of food groups consumed by child over 24h recall period. Scoring 0-9with 1 point for foods that were consumed from each of food groups in previous 24h:starchy staples,dark green leafy vegetables,other vitamin A rich fruits and vegetables,other fruits and vegetables,organ meat, meat and fish, eggs, legumes, nuts, and seeds, milk and milk products. Based on IDDS,participants were listed into 3 food groups: a) less than or equal to [<=]3-low dietary diversity (DD);b)4-5-medium DD;c) greater than or equal to [>=]6-high DD. High score indicates nutrition rich food.|At baseline and month 9|mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.|||Diversity score||Standard Deviation|Mean
2569383|NCT02542865|Secondary|Change From Baseline in Serum Levels of C-reactive Protein (CRP) and Alpha 1-acid Glycoprotein (AGP) Using Blood Testing at Month 9|Quantitative analysis of acute phase proteins such as serum CRP and serum AGP were studied to assess inflammatory status and adjust ferritin status. To quantitate this load, a total volume of approximately 14 milliliters (ml), 7ml each at screening and at month 9, whole blood sample was collected from each participant after application of an anesthetic patch/ointment. The immunoturbidimetry test method was used to measure the levels of CRP and turbidimetry for AGP. The normal range of the serum CRP is less than (<) 0.50 milligrams per deciliter (mg/dL) and serum AGP is 50.00-120.00 mg/dL.|At baseline and month 9|mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.|||mg/dL||Standard Deviation|Mean
2569384|NCT02542865|Secondary|Change From Baseline in Levels of Serum Transferrin Receptor (sTfR) Using Blood Testing at Month 9|Quantitative analysis of sTfR along with serum iron and serum ferritin was studied to measure iron status. In cases of a high prevalence of infection and inflammation, sTfR becomes the choice of iron status marker. To quantitate this load, a total volume of approximately 14 milliliters (ml), 7ml each at screening and at month 9, whole blood sample was collected from each participant after application of an anesthetic patch/ointment. The immunoturbidimetry test method was used to measure the levels. The normal range of sTfR is 1.90-4.40 milligrams per liter (mg/L).|At baseline and month 9||||mg/L||Standard Deviation|Mean
2569385|NCT02542865|Secondary|Change From Baseline in Serum Levels of Ferritin Using Blood Testing at Month 9|Quantitative analysis of serum ferritin was studied to measure iron status. Its value was adjusted by other acute phase proteins such as C-reactive protein (CRP) and Alpha 1-acid glycoprotein (AGP) which are not related to iron status and played a role as a part of assessment on inflammatory status and to adjust ferritin status. To quantitate this load, a total volume of approximately 14 milliliters (ml), 7ml each at screening and at month 9, whole blood sample was collected from each participant after application of an anesthetic patch/ointment. The turbidimetry test method was used to measure the levels.The normal range of serum ferritin is 7.00-140.00 nanograms per milliliter (ng/ml).|At baseline and month 9|mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.|||ng/ml||Standard Deviation|Mean
2569386|NCT02542865|Secondary|Change From Baseline in Serum Levels of Micronutrient Vitamin-E at Month 9|Quantity of micronutrient, serum vitamin-E was used to assess the impact of fortified malt based food product on nutrient biochemistry at month 9. To quantitate the nutrient biochemistry, a total volume of approximately 14 milliliters (ml), 7ml each at screening and at month 9, whole blood sample was collected from each participant after application of an anesthetic patch/ointment. The test method ELISA was used to measure the levels. The normal range of serum vitamin-E is 0.30-0.90 milligrams per deciliter (mg/dL).|At baseline and month 9|mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.|||mg/dL||Standard Deviation|Mean
2569387|NCT02542865|Secondary|Change From Baseline in Serum Levels of Micronutrients Vitamin-D and Serum Folate at Month 9|Quantity of serum vitamin-D (25-hydroxycholecalciferol) and serum folate micronutrients were used to assess the impact of fortified malt based food product on nutrient biochemistry at month 9. To quantitate the nutrient biochemistry, a total volume of approximately 14 milliliters (ml), 7ml each at screening and at month 9, whole blood sample was collected from each participant after application of an anesthetic patch/ointment. The test method ELISA was used to measure the levels. The normal range of serum Vitamin-D is 30.00-100.00 nanograms per milliliter (ng/mL) and serum folate is 5.00-21.00 ng/mL.|At baseline and month 9|mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.|||ng/mL||Standard Deviation|Mean
2569388|NCT02542865|Secondary|Change From Baseline in Serum Levels of Micronutrient Vitamin B12 at Month 9|Quantity of micronutrient, serum vitamin-B12 was used to assess the impact of fortified malt based food product on nutrient biochemistry at month 9. To quantitate the nutrient biochemistry, a total volume of approximately 14 milliliters (ml), 7ml each at screening and at month 9, whole blood sample was collected from each participant after application of an anesthetic patch/ointment. The test method ELISA was used to measure the levels. The normal range of the serum vitamin B12 is 312.00-1237.00 is picograms per milliliter (pg/mL).|At baseline and month 9|mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.|||pg/mL||Standard Deviation|Mean
2569389|NCT02542865|Secondary|Change From Baseline in Serum Levels of Trace Element Selenium (Se) at Month 9|Quantity of the trace element, serum Se was used to assess the impact of fortified malt based food product on nutrient biochemistry at month 9. To quantitate the nutrient biochemistry, a total volume of approximately 14 milliliters (ml), 7ml each at screening and at month 9, whole blood sample was collected from each participant after application of an anesthetic patch/ointment. The test method used was inductively coupled plasma mass spectrometry (ICP-MS). The normal range of serum Se is 55.00-134.00 micrograms per liter (mcg/L).|At baseline and month 9|mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.|||mcg/L||Standard Deviation|Mean
2569390|NCT02542865|Secondary|Change From Baseline in Serum Levels of Micronutrient Vitamin A and Trace Elements Zinc (Zn), Copper (Cu) and Iron (Fe) at Month 9|Quantity of micronutrients, serum vitamin-A and of trace elements Zn, Cu and Fe levels in serum were used to assess the impact of fortified malt based food product on nutrient biochemistry at month 9. To quantitate the nutrient biochemistry, a total volume of approximately 14 milliliters (ml), 7ml each at screening and at month 9, whole blood sample was collected from each participant after application of an anesthetic patch/ointment. The test methods used were ELISA for vitamin-A and colorimetric assays for Zn, Cu and Fe as 5-Br-PAPS; 3,5-Dibromo-PAES and TPTZ, respectively. The normal range of serum Vitamin-A is 26.00-49.00 micrograms per deciliter (mcg/dL) and serum Zn is 78.00-105.00 (male and females aged 7-9 years), 78.00- 118.00 (females aged 10 years) and 78.00-98.00 (males aged 10 years) mcg/dL. The normal range of serum Cu is 51.00-121.00 mcg/dL and serum Fe is 50.00-120.00 mcg/dL.|At baseline and month 9|mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.|||mcg/dL||Standard Deviation|Mean
2569391|NCT02542865|Secondary|Change From Baseline in Mucosal Immunity Using Salivary Immunoglobulin A (IgA) Assessment at Month 9|Quantity of salivary IgA was used to measure the impact of fortified malt based food on mucosal immunity. Saliva was collected using saliva collection aid (SCA). Ribbed-end of the SCA were securely placed into a pre-labeled collection vial. Participants were instructed to pool the saliva in mouth. SCA was placed on mouth entry. Then, participants were asked to tilt the head forward, and gently force saliva through the SCA into the vial to fill with at least 50 microliters (mcL) of volume. A small amount of air space was reserved in the vial to accommodate liquid expansion during freezing. After collection of sample, SCA was removed and discarded and cap was attached to collection vial and tightened. ELISA test method was used to detect the salivary IgA levels. The normal range of salivary IgA is 25.00-168.00 milligrams per liter (mg/L).|At baseline and month 9|mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.|||mg/L||Standard Deviation|Mean
2569414|NCT02542631|Primary|Change in A1C From Baseline to the Completion of 24 Weeks of Basal and Bolus Insulin Therapy|Change in A1C, with bolus insulin dosing with patch versus pen, from baseline to the completion of 24 weeks of basal and bolus insulin therapy|24 weeks|The primary outcome measure analysis used a modified intent-to-treat (mITT) population data set which included all the intent-to-treat (ITT) patients who had a baseline A1C and at least one post-baseline A1C measurement. For missing values, the last observation carried forward (LOCF) imputation method was used.|||A1C %||Standard Error|Least Squares Mean
2569589|NCT02540226|Secondary|Calculated Postoperative Blood Loss||Duration of inpatient hospital stay (average of 3 days)||||mL||Inter-Quartile Range|Median
2569392|NCT02542865|Secondary|Change From Baseline in Gut Integrity/ Health Using Urinary Neopterin Assessment at Month 9|Improvement in gut wall integrity was considered a possible factor to assess the micronutrient absorption. Neopterin test was used to evaluate change in gut wall permeability status to assess impact on micronutrient absorption. Spontaneous random urine was collected from the participants and a volume of 2mL per participant was stored and analysed. Urine sample for this test were collected prior to administration of Lactulose/Mannitol solution. Enzyme-linked immunosorbent assay (ELISA) test method was used to measure the levels. The values were measured in Millimoles per moles of creatinin (mmol/mol creatinin). The normal range of urinary neopterin is 0.10-5.00 mmol/ mol creatinin.|At baseline and month 9|mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.|||mmol/mol creatinin||Standard Deviation|Mean
2569393|NCT02542865|Secondary|Change From Baseline in Gut Integrity/ Health Measured by Urine Lactulose: Mannitol Test at Month 9|Improvement in gut wall integrity was considered a possible factor to assess the micronutrient absorption. Lactulose mannitol test was used to evaluate change in gut wall permeability status to assess impact on micronutrient absorption. After 3h of fasting, pre-measured amount of lactulose/mannitol solution (2 milliliter/Kilogram [mL/Kg] of body weight) containing lactulose (250 milligram/milliliter [mg/mL])] and mannitol (50 mg/mL) was administered as a test solution. Participants were allowed to return to their regular diet 30 minutes after ingestion of the test solution. During the 2.5 h time, participants were offered liquids frequently in order to permit collection of an adequate volume of urine. After 2.5 h, urine collection was performed. All urine passed over duration of 2.5 h was collected and analysed. High Performance Liquid Chromatography (HPLC) test method was used to measure the levels. The normal range of urinary lactulose: mannitol is less than [<] 0.035.|At baseline and month 9|mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.|||Ratio (unitless)||Standard Deviation|Mean
2569394|NCT02542865|Secondary|Change From Baseline in Body Mass Index (BMI) at Month 9|Change in Body Mass Index (BMI) was calculated at month 9 using anthropometric measurements. For measuring participant's height, portable stadio-meter was used with the participant standing barefoot; to the nearest 0.1 centimeters (cm) and average of 3 measurements were recorded. All data recorded in cm were converted to meters (m) for BMI calculation. For measuring participant's weight, standardized weighing scale was used in standard clothing to the nearest 0.1kilograms (kg) and average of 3 measurements were recorded. BMI value was calculated using the formula weight divided by square of height (weight [kilogram (kg)/ Height [meter (m)]^2)|At screening and month 9|mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.|||Kilograms per meter square (kg/m^2)||Standard Deviation|Mean
2569395|NCT02542865|Secondary|School Absenteeism Assessment Due to GI and Respiratory Illnesses at Month 9|School absenteeism was calculated as number of days when a participant failed to attend school because of GI and/or respiratory illnesses. DF was used to note school absenteeism , however it was marked for absenteeism due to GI and respiratory illnesses only.|At month 9|mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.|||Number of days||Standard Deviation|Mean
2569396|NCT02542865|Secondary|Severity of Respiratory Illnesses at Month 9|Intensity of respiratory illness was calculated at month 9 using DF with observations listed by study physician based on assessment of severity grade classified as, Mild or Grade1 is asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Moderate or Grade 2 is minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Instrumental ADL refer to school attendance, playing, studying, participating in school activities; and Severe or Grade 3 and 4: Grade 3 is severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Self-care ADL refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden; Grade 4 is life-threatening consequences; urgent indication indicated.|At month 9|mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.|||Participants|||Count of Participants
2569397|NCT02542865|Secondary|Severity of GI Illnesses at Month 9|Severity of GI illness was calculated at month 9 using DF with observations listed by study physician based on assessment of severity grade: classified as, diarrhea (Mild, increase of less than [<] 4 stools per [/] day over baseline; Moderate, increase of 4 to 6 stools/day over baseline; Severe, increase of more than or equal to [>=]7 loose stools/day over baseline) and vomiting (1-2 episodes, separated by 5 minutes[min] in 24 h; Moderate, 3-5 episodes, separated by 5 min in 24 h; Severe, >=6 episodes, separated by 5 min in 24 h. The count of participants was calculated based on the episode of worst severity. Lower severity indicates no illness of participant.|At month 9|mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.|||Participants|||Count of Participants
2569398|NCT02542865|Secondary|Frequency of GI and Respiratory Illnesses at Month 9|Number of episodes of GI and respiratory illnesses was calculated at month 9 using a diagnosis form (DF) which were used to note the diagnosis, severity, and school absenteeism due to GI and respiratory illnesses only, as defined in the study protocol. The DF captured the start and end date of all occurrences of GI and respiratory illnesses in the week. The frequency was calculated as total number of GI and respiratory illness episodes, divided by duration of intervention, where each episode is defined as each incidence of illness followed by at least uninterrupted 3 symptom free days. Therefore, the formula for calculation used was: frequency (per month) = number of episodes multiply (x) 30 and divided by (/) number of days between first and last visit.|At month 9|mITT population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.|||Number of episodes per month||Standard Deviation|Mean
2569426|NCT02542605|Secondary|Mean Change From Baseline in Creatine Kinase at Day 8, Day 9 and EOS|Creatine Kinase was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.|Part B randomization baseline and day 8, day 9 and EOS (week 12).|The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.|||U/L||Standard Deviation|Mean
2569399|NCT02542865|Primary|Total Number of Ill Days Due to Gastrointestinal (GI) and Respiratory Illness at Month 9|Number of days a participant was ill due to GI and/or respiratory illness as diagnosed by physician, as per criteria defined, over the intervention duration. This equals total number of days (symptomatic or asymptomatic) in illnesses episodes whereas each episode is defined as an incidence of illness followed by at least 3 symptoms free days. GI illness was defined as an acute illness that includes any of following symptoms:3 or more loose/liquid/watery stools and/or vomiting in 24hours (h). Respiratory illness was defined as an acute illness that included more than or equal to [>=] 1 of the following symptoms: runny nose, stuffy or blocked nose, cough fever or chills, sore throat or sneezing.|At month 9|mITT (modified intent-to-treat) population (N=907) included all treated participants with post-treatment assessments who completed the entire study of 9 months.|||Number of days||Standard Deviation|Mean
2569400|NCT02542761|Secondary|Patient Satisfaction as Measured by the Prosthesis Evaluation Questionnaire (PEQ)|The PEQ is a self-administered questionnaire composed of nine scales computed from forty-two items (ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility, well being). Each question uses a visual analog scale format, scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the measured from the left (0-100). The 0 side of the scale is very negative (terrible) and the 100 side of the scale is very positive (excellent). Each scale is reported separately, with a higher score indicating more satisfaction with the prosthesis itself or quality of life.|After approximate 4 week acclimation period|Some participants did not complete some of the scales in the questionnaire.|||units on a scale||Standard Deviation|Mean
2569401|NCT02542761|Secondary|Time of Peak Knee Flexion During Swing|A gait cycle is the period of time for one stride, that is, the time from one event (usually initial foot contact) to the next occurrence of the same event with the same foot. For each leg, the gait cycle can be divided into a stance phase and a swing phase. This variable is expressed as a percentage of the gait cycle.|After approximate 4 week acclimation period||||percentage of gait cycle||Standard Deviation|Mean
2569402|NCT02542761|Secondary|Peak Knee Flexion During Swing|A gait cycle is the period of time for one stride, that is, the time from one event (usually initial foot contact) to the next occurrence of the same event with the same foot. For each leg, the gait cycle can be divided into a stance phase and a swing phase. This variable is measuring the angle of knee flexion during the swing phase.|After approximate 4 week acclimation period||||degrees||Standard Deviation|Mean
2569403|NCT02542761|Secondary|Peak Ankle Power Generation|"Joint power (P) is the dot product of the moment (M) at the joint and the angular velocity (w) of the distal segment with respect to the proximal segment (i.e., P = M · w). Depending on the direction of the moment and the direction of the angular velocity, the power can be positive or negative. If the signs for the moment and angular velocity are both positive or both negative, the power is positive. If the signs for the moment and angular velocity are different, the power is negative. The unit of measurement for this variable is W/kg = watts/kilogram."|After approximate 4 week acclimation period||||W/kg||Standard Deviation|Mean
2569404|NCT02542761|Secondary|Peak Ankle Plantar Flexor Moment During Stance|Peak ankle plantar flexor moment means the peak force of the movement of the foot in which the foot or toes flex downward toward the sole. The unit of measurement for this variable is Nm/kg = 1 nanometer / (kilogram unit).|After approximate 4 week acclimation period||||Nm/kg||Standard Deviation|Mean
2569405|NCT02542761|Primary|Peak Ankle Dorsiflexion During Stance|The peak ankle dorsiflexion is the peak ankle backward flexion or bending when walking.|After approximate 4 week acclimation period||||degrees||Standard Deviation|Mean
2569406|NCT02542631|Secondary|Number of Participants With Severe Hypoglycemic Event|An event requiring the assistance of another person to actively administer carbohydrate (including IV dextrose), glucagon, or other resuscitative actions. Neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.|44 weeks|Intent to Treat. All patients randomized.|||Participants|||Count of Participants
2569407|NCT02542631|Other Pre-specified|Change in Quality of Life From Baseline to Week 24|Change in Diabetes-Specific Quality of Life (QOL), baseline to week 24. was assessed by self-report on the validated Diabetes Specific Quality of Life Survey. Scale is 0-100. Higher score is better.|24 weeks|Per Protocol. Only patients with non-missing baseline and endpoint values were included.|||units on a scale||Standard Error|Least Squares Mean
2569408|NCT02542631|Other Pre-specified|Change in Treatment Satisfaction From Baseline to Week 24|Change in treatment satisfaction with insulin delivery system from baseline to week 24 was assessed by self-report on the validated Insulin Delivery System Rating Questionnaire. Scale is 0-100. Higher score is better.|24 weeks|Per Protocol. Only patients with non-missing baseline and endpoint values were included.|||units on a scale||Standard Error|Least Squares Mean
2569409|NCT02542631|Secondary|Change in A1C From Week 24 to Week 44|Change in A1C from week 24 to week 44 after basal and bolus insulin therapy|44 weeks|Only patients with non-missing week 24 and week 44 values were included.|||A1C %||Standard Error|Least Squares Mean
2569410|NCT02542631|Secondary|Number of Patients With A1C ≤7.0% at Week 44|Number of patients with A1C ≤7.0% after 44 weeks of basal and bolus insulin therapy|44 weeks|Only patients with non-missing baseline and endpoint values were included.|||Participants|||Count of Participants
2569411|NCT02542631|Secondary|Change in A1C From Baseline to Week 44|Change in A1C from baseline to the completion of 44 weeks of basal and bolus insulin therapy|44 weeks|Only patients with non-missing baseline and endpoint values were included.|||A1C %||Standard Error|Least Squares Mean
2569412|NCT02542631|Secondary|Change in Percent of Glucose Values of Continuous Glucose Monitoring (CGM) Measurements Within Targeted Range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) From Baseline to Week 24|Change in percent of glucose values of Continuous Glucose Monitoring (CGM) measurements within targeted range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) from baseline to week 24 (in a subset of patients)|24 weeks|Modified intent-to-treat population data subset.|||% of glucose values||Standard Error|Least Squares Mean
2569413|NCT02542631|Secondary|Number of Patients With A1C ≤7.0% at Week 24|Number of patients with A1C ≤7.0% at week 24|24 weeks|Modified intent-to-treat (mITT) population data set.|||Participants|||Count of Participants
2571692|NCT02513732|Secondary|Number of Participants With Death,Myocardial Infarction and Revascularization(DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|0 to 5 years|ITT population|||Participants|||Count of Participants
2569415|NCT02542605|Secondary|Number of Participants With Clinically Significant Changes in Neurological Assessments|Neurological examinations including assessment of cranial nerves, motor system, sensory system (including testing for pain sensation [pin prick], light touch sensation [brush], von Frey, and vibratory sense), reflexes, and cerebellar function were performed by the investigator and classified as normal or abnormal. Any abnormal findings, judged by the investigator to be clinically significant, were recorded as an AE. The number of participants with clinically significant changes in neurological assessments at EOS are presented.|Part B randomization phase baseline and EOS.|The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B.|||Participants|||Count of Participants
2569416|NCT02542605|Secondary|Number of Participants With Clinically Significant Changes in Physical Parameters|Physical examinations were performed by an investigator and any abnormal findings, judged to be clinically significant were recorded as an AE. The number of participants with clinically significant changes in physical parameters at EOS are presented.|Part B randomization phase baseline and EOS.|The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B.|||Participants|||Count of Participants
2569417|NCT02542605|Secondary|Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters|At baseline, 12-lead ECGs were performed in a standardized method, in triplicate, and approximately 30 seconds apart, prior to blood draws or other invasive procedures. Single ECGs were performed from Day 1 to EOS. ECG results were reviewed by the investigator and classified as: normal, abnormal not clinically significant or abnormal, clinically significant. The number of participants with abnormal, clinically significant changes in ECG results at EOS are presented.|Part B randomization phase baseline and EOS.|The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B.|||Participants|||Count of Participants
2569418|NCT02542605|Secondary|Number of Participants With Anti-Erenumab Antibodies|Participants were tested for binding antibodies and neutralizing antibodies at baseline and following treatment with erenumab.|Part B randomization phase baseline and EOS.|The Safety Analysis Set for erenumab consisted of all randomized participants who received at least 1 dose of erenumab in Part B.|||Participants|||Count of Participants
2569419|NCT02542605|Secondary|PK: Mean Area Under the Concentration-time Curve From Time 0 to 84 Days Post-dose (AUC84d)|The mean AUC84d for erenumab for the Part B randomization phase is presented.|Part B randomization phase baseline and 84 days post-dose.|The PK Analysis Set consisted of all randomized participants who received erenumab and have at least 1 PK concentration result.|||day*mcg/mL||Standard Deviation|Mean
2569420|NCT02542605|Secondary|Pharmacokinetics (PK): Mean Erenumab Serum Concentration at 1 Hour (C1h)|The mean serum erenumab concentration at 1 hour post-dose on day 1 of Part B randomization phase is presented.|Part B randomization phase 1 hour post-dose day 1.|The PK Analysis Set consisted of all randomized participants who received erenumab and have at least 1 PK concentration result.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
2569421|NCT02542605|Secondary|Mean Change From Baseline in Hemoglobin A1C (Fraction of 1) at Day 8, Day 9 and EOS|Hemoglobin A1C was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.|Part B randomization baseline and day 8, day 9 and EOS (week 12).|The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.|||fraction of 1||Standard Deviation|Mean
2569422|NCT02542605|Secondary|Mean Change From Baseline in Blood Glucose at Day 8, Day 9 and EOS|Blood glucose was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.|Part B randomization baseline and day 8, day 9 and EOS (week 12).|The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.|||mmol/L||Standard Deviation|Mean
2569423|NCT02542605|Secondary|Mean Change From Baseline in Eosinophil Count at Day 8, Day 9 and EOS|Eosinophil count was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.|Part B randomization baseline and day 8, day 9 and EOS (week 12).|The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.|||10^9/L||Standard Deviation|Mean
2569424|NCT02542605|Secondary|Mean Change From Baseline in Direct Bilirubin at Day 8, Day 9 and EOS|Direct bilirubin was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.|Part B randomization baseline and day 8, day 9 and EOS (week 12).|The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.|||micromol/L||Standard Deviation|Mean
2569425|NCT02542605|Secondary|Mean Change From Baseline in Creatinine at Day 8, Day 9 and EOS|Creatinine was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.|Part B randomization baseline and day 8, day 9 and EOS (week 12).|The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.|||micromol/L||Standard Deviation|Mean
2571693|NCT02513732|Secondary|Number of Participants With Death,Myocardial Infarction and Revascularization(DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|0 to 4 years|ITT population|||Participants|||Count of Participants
2569427|NCT02542605|Secondary|Mean Change From Baseline in Blood Urea at Day 8, Day 9 and EOS|Blood urea was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.|Part B randomization baseline and day 8, day 9 and EOS (week 12).|The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.|||millimol/L (mmol/L)||Standard Deviation|Mean
2569428|NCT02542605|Secondary|Mean Change From Baseline in Total Bilirubin at Day 8, Day 9 and EOS|Total bilirubin was assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.|Part B randomization baseline and day 8, day 9 and EOS (week 12).|The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.|||micromol/L||Standard Deviation|Mean
2569429|NCT02542605|Secondary|Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) at Day 8, Day 9 and EOS|ALP, ALT and AST were assessed during Part B of the study, and the mean change from baseline is presented for samples taken prior to administration of PACAP-38 on day 8 (pre-PACAP-38 dose), and following administration of PACAP-38 on day 9. The mean change from baseline is also presented for the EOS assessment.|Part B randomization phase baseline and day 8, day 9 and EOS (week 12).|The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.|||Units/Liter||Standard Deviation|Mean
2569430|NCT02542605|Secondary|Mean Change From Baseline in Temperature at Day 1, Day 8 and EOS|Temperature was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.|Part B randomization phase baseline and day 1, day 8 and EOS (week 12).|The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.|||degrees Celsius||Standard Deviation|Mean
2569431|NCT02542605|Secondary|Mean Change From Baseline in Respiratory Rate at Day 1, Day 8 and EOS|Respiratory rate was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.|Part B randomization phase baseline and day 1, day 8 and EOS (week 12).|The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.|||breaths/minute||Standard Deviation|Mean
2569432|NCT02542605|Secondary|Mean Change From Baseline in Heart Rate at Day 1, Day 8 and EOS|Heart rate was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.|Part B randomization phase baseline and day 1, day 8 and EOS (week 12).|The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.|||beats/minute||Standard Deviation|Mean
2569433|NCT02542605|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Day 1, Day 8 and EOS|Systolic and diastolic BP was assessed during Part B of the study, and the mean change from baseline is presented for the last measurements taken following administration of placebo or erenumab on day 1 (1 hour post-dose), and following administration of PACAP-38 on day 8 (8 hours post-dose). The mean change from baseline is also presented for the EOS assessment.|Part B randomization phase baseline and day 1, day 8 and EOS (week 12).|The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B. Only participants with data available for analysis at each time point are presented.|||millimeters of mercury||Standard Deviation|Mean
2569434|NCT02542605|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|TEAEs were summarised for days 1 to 7 after the participants received placebo or erenumab infusion on day 1 of the Part B randomization phase. TEAEs were also summarized from day 8 to end of study (EOS) after participants had received both investigational product (placebo or erenumab) and the second dose of PACAP-38 on day 8.|Part B randomization phase day 1 until EOS (up to 12 weeks).|The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B.|||Participants|||Count of Participants
2569435|NCT02542605|Secondary|Number of Participants With a Headache Within 24 Hours of Challenge Agent Infusion|On day 1 of the double-blind randomization phase participants received 140 mg intravenous erenumab over 30 minutes or matching placebo. On day 8, participants received 10 mol/kg/minute PACAP-38 over 10 minutes and were observed for 24 hours after PACAP-38 infusion.|Part B randomization phase day 8 plus 24 hours.|The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B.|||Participants|||Count of Participants
2569453|NCT02542072|Secondary|Film Deposits|Front surface film deposits for comfilcon A and samfilcon A lenses. Scale 0-4, 0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=Heavy film visible to the naked eye.|2 weeks and 4 weeks||||units on a scale|Eyes|Standard Deviation|Mean
2569454|NCT02542072|Secondary|Lens Surface Wetting|Lens surface wettability assessment for comfilcon A and samfilcon A lenses. Scale 0-4 in 0.5 steps, 0=very poor, 4=excellent|Baseline, 2 weeks, 4 weeks||||units on a scale|Eyes|Standard Deviation|Mean
2569436|NCT02542605|Primary|Number of Participants With a MLA Within 24 Hours of Challenge Agent Infusion|"On day 1 of the double-blind randomization phase participants received 140 mg intravenous erenumab over 30 minutes or matching placebo. On day 8, participants received 10 mol/kg/minute PACAP-38 over 10 minutes and were observed for 24 hours after PACAP-38 infusion.~A MLA was defined as fulfilling 1 of the 2 criteria:~Headache with at least 2 of the following characteristics: unilateral location, pulsating quality, moderate or severe pain intensity, aggravated by/causing avoidance of routine physical activity. Additionally, during the headache at least 1 of the following: nausea and/or vomiting, photophobia or phonophobia.~Headache described as mimicking usual migraine attack treated with triptan."|Part B randomization phase day 8 plus 24 hours.|The Safety Analysis Set consisted of all randomized participants who received at least 1 dose of investigational product (placebo or erenumab) in Part B.|||Participants|||Count of Participants
2569437|NCT02542462|Primary|The Feasibility of Conducting a Larger Scale Study as Determined by the Percentage of Participants Who Completed All Study Visits|Study will be determined to be feasible on a larger scale if 70% or more of randomized subjects complete all study visits and remain in the study until completion|15 months|All randomized subjects, irrespective of arm assignment|||Participants|||Count of Participants
2569438|NCT02542462|Primary|The Feasibility of Conducting a Larger Scale Study as Determined by Study Recruitment Rates (Number of Participants Eligible/Participants Who Enrolled)|Study will be determined to be feasible on a larger scale if 10% or more of eligible subjects enroll in the study|15 months|During the study period, there were 252 children screened and of these, 238 were eligible for enrollment. These subjects were identified through screening at a primary care clinic and through advertisement.|||Participants|||Count of Participants
2569439|NCT02542462|Primary|The Effects of RV1 and RV5 With or Without Other Routine Immunizations on Gastrointestinal Anatomy|Number of subjects with an increase in the number of abdominal lymph nodes, as measured by abdominal ultrasound, or an increase of 1 mm or more of terminal ileum wall thickness, as measured by abdominal MRI, from Day 0 (Visit 1) to Day 4-6 (Visit 2)|4- 6 days|Subjects had an abdominal MRI followed by an abdominal ultrasound prior to receiving vaccines at Day 0 (Visit 1). They returned 4-6 days later for follow up MRI and Ultrasound post vaccination (Visit 2) Terminal ileum thickness was measured and compared pre-post. Abdominal lymph nodes seen on ultrasound were compared pre-post|||Participants|||Count of Participants
2569440|NCT02542410|Secondary|Changes in Pain Interference Scores|"Brief Pain Inventory Interference subscale is a 7-item self-report measure, designed to assess the extent to which pain interferes with various components of functioning, including physical and emotional functioning and sleep.The items in this scale can be grouped into those that assess physical functioning (general activity; walking ability; normal work, including both work outside the home and housework), those that assess emotional functioning (mood; relations with people; enjoyment of life), and a single item that assess the extent to which pain interferes with sleep. The arithmetic mean of the seven interference items is used as a measure of pain interference (i.e., how much a participant's pain interferes with her ability to complete activities of daily living and functioning). The score on the pain interference subscale ranges from 0-70. Higher scores are worse outcomes.~Outcome measure calculated as the value at 6 months minus the value at baseline"|Baseline, 6 months||||units on a scale||Standard Error|Mean
2569441|NCT02542410|Primary|Change in Score in Worst Pain Over the Last Month|"visual analog scale, minimum=0 and maximum=10 Higher numbers are a worse outcome~Outcome measures is calculated as the value at 6 months minus value at baseline."|Baseline, 6 months||||score on a scale||Standard Deviation|Median
2569442|NCT02542280|Primary|Clinical Pregnancy Rate|Ultrasound detection of an intrauterine positive fetal heart pulsations|six weeks||||participants|||Number
2569443|NCT02542280|Primary|Chemical Pregnancy Rate|Human chorionic gonadotrophin (b-hcg) detection in serum two weeks after intrauterine insemination.|two weeks after intrauterine insemination||||participants|||Number
2569444|NCT02542072|Secondary|Dryness|Subjective response of dryness for comfilcon A and samfilcon A lenses during a typical day of wear and prior to removal. Scale of 0-10, 10=No dryness, 0=Extremely dry|Baseline, 2 weeks, 4 weeks||||units on a scale||Standard Deviation|Mean
2569445|NCT02542072|Secondary|Overall Fit Acceptance|Overall fit acceptance for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect|Baseline, 2 weeks, 4 weeks||||units on a scale||Standard Deviation|Mean
2569446|NCT02542072|Secondary|Lens Tightness Push-up|"Investigator assessment of lens tightness push-up for comfilcon A and samfilcon A lenses.~Scale 0%-100% continuous scale, 100%=No movement, 50%=Optimum, 0%=Falls from cornea without lid support"|Baseline, 2 weeks, 4 weeks||||percentage of mean lens tightness|Eyes|Standard Deviation|Mean
2569447|NCT02542072|Secondary|Primary Gaze Lag|Investigator assessment of primary gaze lag for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement|Baseline, 2 weeks, and 4 weeks||||units on a scale|Eyes|Standard Deviation|Mean
2569448|NCT02542072|Secondary|Post-Blink Movement|Post-blink movement for comifilcon A and samfilcon A lenses are assessed. 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement|Baseline, 2 weeks, 4 weeks||||units on a scale|Eyes|Standard Deviation|Mean
2569449|NCT02542072|Secondary|Corneal Coverage|"Investigator assessment of corneal coverage for comfilcon A and samfilcon A lenes.~Yes = coverage at all times or No = coverage incomplete"|Baseline Visit, 2 weeks follow-up, 4-weeks follow-up||||percentage of eyes|Eyes||Number
2569450|NCT02542072|Secondary|Lens Centration|Lens centration will be recorded by degree and direction in the primary position. 0=Centered -optimal, 1=Decentered slightly, 2=Substantially decentered (>0.5mm)|Baseline, 2 weeks, 4 weeks||||Eyes|Eyes||Number
2569451|NCT02542072|Secondary|Visual Acuity (VA)|Visual acuity (VA) for comfilcon A and samfilcon A lens wear is assessed using Snellen.|Baseline, 2 weeks, 4 weeks||||LogMAR||Standard Deviation|Mean
2569452|NCT02542072|Secondary|White Spot Deposits|Number of white spot deposits for comfilcon A and samfilcon A lenses.|2 weeks and 4 weeks||||number of white spots|Eyes|Standard Deviation|Mean
2569455|NCT02542072|Secondary|Biomicroscopy Scores|Biomicroscopy for comfilcon A and samfilcon A lens assessed. Scale 0-4 in 0.5 steps 0=none, 1=trace, 2=mild, 3=moderate, 4=severe|Baseline, 2 weeks, 4 weeks||||units on a scale|Eyes|Standard Deviation|Mean
2569460|NCT02542072|Secondary|Comfortable Wearing Time Via SMS (Short Message Service)|Comfortable wearing times (WTs) via SMS (Short Message Service) for comfilcon A and samfilcon A lenses assessed at days 3, 12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale of 0-10 (0=painful, 10=can't feel the lenses).|Days 3, 12, 26|Number of participants analyzed may differ from participant flow due to protocol deviations.|||units on a scale||Standard Deviation|Mean
2569461|NCT02542072|Primary|Comfort|Subjective ratings of comfort (comfort after insertion, typical comfort just prior to removal, and overall comfort) for comfilcon A and samfilcon A assessed at baseline, 2 weeks, and 4 weeks. Scale of 0-10 (0=painful, 10=can't feel the lenses).|Baseline, 2 weeks, 4 weeks|Number of participants analyzed is different from participant flow due to protocol deviations.|||units on a scale||Standard Deviation|Mean
2569462|NCT02542046|Secondary|Extent of Bowel Opacification of Bowel at CT Imaging|The most distal segment of bowel (stomach, jejunum, ileum, and /or colon) that was opacified by contrast material at the time of CT imaging was recorded|within 1 day from administration of oral contrast. The CT scan generally occurs within 3 hours after oral contrast administration, and the CT scan images will be evaluated for imaging appearance of oral contrast seen in bowel for this outcome.||||Participants|||Count of Participants
2569463|NCT02542046|Primary|Severity of CT Imaging Artifacts Caused by the Oral Contrast Agent|For the segments of bowel visibly opacified by oral contrast, the severity of CT imaging artifacts caused by the oral contrast agent was recorded on the following 3 point scale: 0 = no artifact; 1 = mild artifact without impairment of anatomic delineation; 2 = severe artifact with impairment of anatomic delineation. Lower scores are preferred|within 1 day from administration of oral contrast. The CT scan generally occurs within 3 hours after oral contrast administration, and the CT scan images will be evaluated for the imaging appearance of oral contrast uniformity for this outcome.||||Participants|||Count of Participants
2569464|NCT02542046|Primary|Number of Participants With Non-uniform Bowel Lumen Opacification at CT Imaging|Nonuniform contrast enhancement of the bowel lumen is a potential diagnostic pitfall at CT imaging since non-uniform enhancement may be distracting to the reader and interfere with accurate diagnosis. Conversely, homogeneously enhancing bowel lumen makes it easier to assess the bowel for potential disease. For each patient's CT scan, the bowel that is seen to be visibly opacified by oral contrast at CT imaging will be assessed as a whole as showing the presence or absence of nonuniform contrast enhancement of the lumen.|within 1 day from administration of oral contrast. The CT scan generally occurs within 3 hours after oral contrast administration, and the CT scan images will be evaluated for the imaging appearance of oral contrast uniformity for this outcome.||||Participants|||Count of Participants
2569465|NCT02541942|Primary|Determination of Polymorphisms in the FVII Gene|Determination of polymorphisms in the FVII gene in patients who participated in the completed NN1731-3562 (adeptTM2) phase 3 trial, with 5 or more exposure days to trial product rFVIIa analogue and/or rFVIIa.|Up to 12 months||||Number of polymorphism|||Number
2569466|NCT02541942|Primary|Determination of HLA Type|HLA typing includes up to 8 different HLA types (HLA-DRB1/B3/B4/B5, DPA1/B1 and DQA1/B1) and their most likely alleles. Number of participants with most likely HLA allele are reported.|Up to 12 months|All enrolled patients|||subjects|||Number
2569467|NCT02541903|Secondary|Toxicities|The number of adverse events and serious adverse events will be tabulated using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.|Baseline up to 18 months||||Number of toxicities seen in patients|||Number
2569468|NCT02541903|Secondary|Overall Survival|From date of study enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 30 months.|Baseline to death (assessed up to 30 months).||||days||90% Confidence Interval|Mean
2569469|NCT02541903|Secondary|Response Rate|The Response Evaluation Criteria in Solid Tumors guidelines version 1.1 and disease assessment scans (bone, CT) will be used to evaluate tumor response.|Baseline up to 3 months|The response rate was calculated using those participants that showed regression or shrinkage at restaging scans.|||Participants|||Count of Participants
2569470|NCT02541903|Primary|Number of Participants With Progression Free Survival at 6 Months|Death will signify the time of progression free survival. Otherwise, the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 will be used to evaluate disease progression. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|6 months following study treatment|1 participant expired before receiving treatment|||Participants|||Count of Participants
2569471|NCT02541864|Primary|Number of Participants in Which H. Pylori Was Eradicated|Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests are conducted to assess H. pylori status.|at the 6th week after the end of anti- H. pylori therapy|Intention to treat|||participants|||Number
2569472|NCT02541669|Primary|Terminal Phase Elimination Half-life (T1/2) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The PK set consisted of all participants who received study drug and had at least 1 measurable plasma concentration for TAK-536.|||hour||Geometric Coefficient of Variation|Geometric Mean
2569473|NCT02541669|Primary|AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10||Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose|PK set where Day 10 assessments were available. The PK set consisted of all participants who received study drug and had at least 1 measurable plasma concentration for TAK-536.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2569474|NCT02541669|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The PK set consisted of all participants who received study drug and had at least 1 measurable plasma concentration for TAK-536.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2569475|NCT02541669|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10||Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose|PK set where Day 10 assessments were available. The PK set consisted of all participants who received study drug and had at least 1 measurable plasma concentration for TAK-536.|||hour||Full Range|Median
2569476|NCT02541669|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The PK set consisted of all participants who received study drug and had at least 1 measurable plasma concentration for TAK-536.|||hour||Full Range|Median
2569477|NCT02541669|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10||Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose|PK set where Day 10 assessments were available. The PK set consisted of all participants who received study drug and had at least 1 measurable plasma concentration for TAK-536.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2569478|NCT02541669|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|The pharmacokinetic (PK) set consisted of all participants who received study drug and had at least 1 measurable plasma concentration for TAK-536.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2569479|NCT02541604|Secondary|Optimal Dose of Atezolizumab in Young Adult Participants|Atezolizumab was administered on Day 1 only for a cycle duration of 3 weeks.|From baseline up to approximately 42 months||||mg|||Number
2569480|NCT02541604|Secondary|Optimal Dose of Atezolizumab in Pediatric Adult Participants|Atezolizumab was administered on Day 1 only for a cycle duration of 3 weeks.|From baseline up to approximately 42 months||||mg/kg|||Number
2569481|NCT02541604|Secondary|DOR as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma||Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Months||95% Confidence Interval|Median
2569482|NCT02541604|Secondary|DOR as Determined by the Investigator Using irRC for Participants With Neuroblastoma||Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug. No participants had response therefore no participants analyzed.||||||
2569483|NCT02541604|Secondary|DOR as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors||Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Months||95% Confidence Interval|Median
2569484|NCT02541604|Secondary|PFS as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma||Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Months||95% Confidence Interval|Median
2569485|NCT02541604|Secondary|PFS as Determined by the Investigator Using irRC for Participants With Neuroblastoma||Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Months||95% Confidence Interval|Median
2569486|NCT02541604|Secondary|PFS as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors||Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Months||95% Confidence Interval|Median
2569487|NCT02541604|Secondary|Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using irRC for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma||Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Percentage|||Number
2569488|NCT02541604|Secondary|Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Immune-Related Response Criteria (irRC) for Participants With Neuroblastoma||Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Percentage|||Number
2569489|NCT02541604|Secondary|Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors||Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Percentage|||Number
2569490|NCT02541604|Secondary|Overall Survival (OS)||Baseline until death (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Months||95% Confidence Interval|Median
2569491|NCT02541604|Secondary|DOR as Determined by the Investigator Using RANO Criteria in Participants With ATRT||Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug. No participants had an objective response in this cohort.||||||
2569492|NCT02541604|Secondary|DOR as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma||Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Months||95% Confidence Interval|Median
2569493|NCT02541604|Secondary|DOR as Determined by the Investigator Using mINRC in Participants With Neuroblastoma||Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.||||||
2569494|NCT02541604|Secondary|Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 Criteria in Participants With Solid Tumors||Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Months||95% Confidence Interval|Median
2569495|NCT02541604|Primary|Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab||PRD (0 hr) on D1 of Cy1,2,3,4,8,12,16 (1 Cy=21 days) & every 8 cycles thereafter; at any time during visit on Cy1D8, study drug discontinuation, at least 90 days (maximum 150 days) after last dose of study drug (up to approximately 42 months)|The baseline ADA-evaluable population included patients who had a baseline ADA result. The post-baseline ADA-evaluable population included patients who had at least one post-baseline ADA result and had received at least one dose of that study treatment. Patients never dosed and patients without valid ADA records were not included in the analysis.|||Percentage|||Number
2569496|NCT02541604|Primary|Area Under the Concentration-Time Curve (AUC) of Atezolizumab||PRD (0 hr), 0.5 hr P-I (infusion duration=30-60 minutes) on D1 of Cy1; at any time during visit on Cy1D8 (1 Cy=21 days)|Included PK population, defined as patients who had received any amount of study drug and had at least one serum concentration result available at clinical data cutoff.|||ugxday/mL||Geometric Coefficient of Variation|Geometric Mean
2569497|NCT02541604|Primary|Atezolizumab Serum Concentration at Washout||At least 90 days (maximum 150 days) after last dose of study drug (up to approximately 42 months)|Included PK population, defined as patients who had received any amount of study drug and had at least one serum concentration result available at clinical data cutoff.|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2569498|NCT02541604|Primary|Minimum Serum Concentration (Cmin) of Atezolizumab||PRD (0 hr) on D1 of Cy2,3,4,8, 12, 16 (1 Cy=21 days) and every 8 cycles thereafter; at any time during visit at study drug discontinuation visit, at least 90 days (maximum 150 days) after the last dose of study drug (up to approximately 42 months)|"Included PK population, defined as patients who had received any amount of study drug and had at least one serum concentration result available at clinical data cutoff. In the <2 Age (Years) Arm/Group, 1 participant died after study entry with 1 cycle, and the other participant died after two cycles."|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2569499|NCT02541604|Primary|Maximum Serum Concentration (Cmax) of Atezolizumab||Predose (PRD; 0 hours [hr]), 0.5 hr post-infusion (P-I; infusion duration=30-60 minutes) on Day (D) 1 of Cycle (Cy) 1 and 4 (1 Cy=21 days)|"Included PK population, defined as patients who had received any amount of study drug and had at least one serum concentration result available at clinical data cutoff. In the <2 Age (Years) Arm/Group, 1 participant died after study entry with 1 cycle, and the other participant died after two cycles."|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2569500|NCT02541604|Primary|Percentage of Participants Adverse Events, Serious Adverse Events and Adverse Events of Special Interest||From baseline up to approximately 42 months|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Percentage|||Number
2569501|NCT02541604|Primary|PFS as Determined by the Investigator Using RANO Criteria in Participants With ATRT||Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Months||95% Confidence Interval|Median
2569502|NCT02541604|Primary|PFS as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma||Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Months||95% Confidence Interval|Median
2569503|NCT02541604|Primary|PFS as Determined by the Investigator Using mINRC in Participants With Neuroblastoma||Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Months||95% Confidence Interval|Median
2569504|NCT02541604|Primary|Progression-Free Survival (PFS) as Determined by the Investigator Using RECIST v1.1 in Participants With Solid Tumors||Baseline until first documented occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Months||95% Confidence Interval|Median
2569505|NCT02541604|Primary|Percentage of Participants With Clinical Benefit as Determined by the Investigator According to RECIST v1.1 Criteria in Participants With Osteosarcoma||Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population (defined as patients who received any amount of study drug), in the Osteosarcoma cohort as per protocol. (Objective response for the other cohorts are measured with different response criteria, and these are described in Outcome Measures 1, 2, 3, and 4).|||Percentage|||Number
2569506|NCT02541604|Primary|Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Response Assessment in Neuro-Oncology (RANO) Criteria in Participants With Atypical Teratoid Rhabdoid Tumor (ATRT)||Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Percentage|||Number
2569507|NCT02541604|Primary|Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Revised Response Criteria for Malignant Lymphoma for Participants With Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma||Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Percentage|||Number
2569508|NCT02541604|Primary|Percentage of Participants With an Objective Response (CR or PR) as Determined by the Investigator Using Modified International Neuroblastoma Response Criteria (mINRC) in Participants With Neuroblastoma||Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Percentage|||Number
2569509|NCT02541604|Primary|Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Participants With Solid Tumors|Note: In Cohort 5, the response was observed in a rhabdoid tumor. Participant was erroneously enrolled in the Non-rhabdomyosarcoma soft tissue sarcoma cohort.|Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)|Included safety-evaluable population, defined as patients who received any amount of study drug.|||Percentage|||Number
2569510|NCT02541422|Primary|Hangover Symptom Scale|"In the morning, each participate will fill out a Hangover Symptom Score questionnaire, evaluating each hangover symptom on a 0 - 4 point Hangover Symptom Severity scale. 0 representing strongly disagree or feels like I did not drink last night to 4 representing strongly agree or I'm so hungover / I'm never drinking again for each symptom. The symptoms on the Hangover Symptom Scale are: feeling thirsty or dehydrated, feeling more tired than usual, headache, nauseated, vomited, feeling weak, difficulty concentrating, more sensitive to light and sound than usual, sweating more than usual, had trouble sleeping, feeling anxious, feeling depressed, experienced trembling or shaking. The total score could range from 0-52 with 0 being no symptoms of hangover and 52 being the worst symptoms of hangover. This study looked specifically at the overall hangover score, nauseated, feeling weak and headache."|12 hours or less||||units on a scale||Full Range|Median
2569511|NCT02540850|Secondary|Consistency (the Overall Ratio of True Positive and True Negative)|The overall consistency ratio of true positive and true negative, i.e. (true positive+true negative)/total number of cases|1 year||||percentage of true pos&negs in all cases|||Number
2569512|NCT02540850|Secondary|Positivity Rate (The Ratio of Positive mSEPT9 Results in the Population)|the ratio of positive cases in all cases|1 year||||percentage of positives in each group|||Number
2569513|NCT02540850|Secondary|NPV (the Negative Predictive Value of mSEPT9 Assay in the Population)|the ratio of true negative in all negative cases|1 year||||percentage of true negs in all neg cases|||Number
2569514|NCT02540850|Secondary|PPV (the Positive Predictive Value of mSEPT9 Assay in the Population)|the ratio of true positive in all positive cases|1 year||||percentage of true pos in all pos cases|||Number
2569515|NCT02540850|Secondary|Specificity (Specificity of mSEPT9 Assay in Non-CRC Diseases and NED (no Evidence of Diseases))|the ratio of negative cases in all non-CRC or NED cases|1 year||||percentage of true negs in non-CRC group|||Number
2569516|NCT02540850|Secondary|Sensitivity (Sensitivity of mSEPT9 Assay in Detecting Colorectal Cancer)|the ratio of positive cases in all CRC cases|1 year||||Percentage of positives in disease group|||Number
2569517|NCT02540850|Primary|Ct Value (Ct Values From PCR Reaction)|the number of PCR cycles where the amplification signal starts to be observed|1 year||||Ct||95% Confidence Interval|Mean
2569518|NCT02540772|Secondary|Number of Errors in Source Attribution|"After the recall of the material, patients were also asked to remember which modality corresponded to each recall (i.e., seen, heard or imagined), and who had presented the material during the learning session (i.e., the therapist or themselves).~Scores ranged from 0 (if all answers were non-responses) to unlimited number (depending on number of confabulations produced by patients).~The values in the table represent the mean of errors in source attribution for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment)."|Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them|Minimum number for comparison of means calculated with G*Power software (see Analysis Population Description of the first outcome measure data, i.e., confabulations).|||Errors in source attribution||Standard Deviation|Mean
2569519|NCT02540772|Primary|Number of Non-responses|"Scores ranged from 0 (no non-responses) to 72 (12 stimuli remembered twice in each session: firstly, in a immediate recall after learning, and secondly, in a delayed recall after 10 minutes).~The values in the table represent the mean of non-responses for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment)."|Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them|Minimum number for comparison of means calculated with G*Power software (see Analysis Population Description of the first outcome measure data, i.e., confabulations).|||Non-responses||Standard Deviation|Mean
2569520|NCT02540772|Primary|Number of Correct Responses|"Scores ranged from 0 (no correct answers) to 72 (12 stimuli remembered twice in each session: firstly, in a immediate recall after learning, and secondly, in a delayed recall after 10 minutes).~The values in the table represent the mean of correct responses for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment)."|Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them|Minimum number for comparison of means calculated with G*Power software (see Analysis Population Description of previous outcome measure data, i.e., confabulations).|||Correct responses||Standard Deviation|Mean
2569521|NCT02540772|Primary|Number of Confabulations|"The confabulations recorded were 1) guessed answers, 2) confusions in time and space, 3) a mixture of two or more stimuli presented, and 4) devised or bizarre responses.~Scores ranged from 0 (no confabulations) to unlimited number of them (because devised or bizarre responses were recorded) and consisted of the sum of all the confabulations produced during the baseline. The values in the table represent the mean of confabulations for each group (Neuropsychological treatment or No treatment) in the 3 sessions at each baseline (pre- and post-treatment)."|Measures were recorded during 3 sessions administered in 1 week before (pre-baseline) and during 3 sessions after the treatment (post-baseline). In the control group, pre and post baselines were also recorded but without any treatment between them|We used preliminary data from the first 5 patients using the G*Power software to calculate the sample size. From them, to detect differences through a Student t-test considering the significance level is 5%, the sample size was estimated in 7 subjects per group with an alpha of 0.95. We expanded to 10 to ensure greater power.|||Confabulations||Standard Deviation|Mean
2569522|NCT02540668|Secondary|Pharmacodynamics (PD): Maximum Observed INR Response (INRmax) of Warfarin||Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22|All participants who received at least one dose of study drug and had evaluable pharmacodynamic INR data on Day 22 of Period 2.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2569523|NCT02540668|Secondary|Pharmacodynamics (PD): Area Under the International Normalized Ratio (INR) Versus Time Curve (AUCINR) of Warfarin||Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22|All participants who received at least one dose of study drug and had evaluable pharmacodynamic INR data on Day 22 of Period 2.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2569524|NCT02540668|Secondary|Pharmacokinetics (PK): Area Under The Concentration Curve 0-∞(AUC) of Unbound R-Warfarin||Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96,120, and 144 hours after administration of warfarin on Days 1 and 22|All participants who received at least one dose of study drug.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2569525|NCT02540668|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound R-Warfarin||Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22|All participants who received at least one dose of study drug.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2569526|NCT02540668|Primary|Pharmacokinetics (PK): Area Under the Concentration Curve 0-∞ (AUC) of Unbound S-Warfarin||Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22|All participants who received at least one dose of study drug.|||nanogram * hour per milliliter(ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2569527|NCT02540668|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound S-Warfarin||Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22|All participants who received at least one dose of study drug.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2569528|NCT02540629|Secondary|Number of Participants With Good Neurological Recovery at Discharge|Number of EMS-assessed out-of-hospital cardiac arrest patients who survive to hospital discharge and has cerebral performance category 1 or 2 will be recorded.|At hospital discharge, up to 28 weeks from hospital admission||||Participants|||Count of Participants
2569529|NCT02540629|Primary|Number of Participants With Survival to Hospital Discharge|Number of EMS-assessed out-of-hospital cardiac arrest patients who survive to hospital discharge will be recorded.|At hospital discharge, up to 28 weeks from hospital admission||||Participants|||Count of Participants
2569530|NCT02540538|Secondary|Number of Participants With Seroprotection|Seroprotection at visit number 7, one month after the third vaccination. Anti-HBs antibodies were assayed from serum using a routine chemiluminescence assay (Anti-HBs, Cobas 8000, Roche, Germany). Titres >10 mIU/mL were considered to be seroprotective.|Day 0, 10, 30, 40, 60, 180, and 210|RCT: 27 participants screened, 3 excluded: 1 with LFTs abnormalities, 1 anti-HBs titre >10 mIU/mL, 1 suspected Cushing’s syndrome. 24 included. Open-Label: 10 screened and included.|||Participants|||Count of Participants
2569531|NCT02540538|Primary|Subjects With Local and/or General SEVERE Adverse Events|"Subjects will be given a diary for 4 days after the first and second vaccination.~Dairy: Local reactions at injection site: Pain (1 to 4), Impaired movement of injected arm (1 to 4), Redness/erythema (cm), Swelling (cm), Induration (cm) General/Systemic adverse events: Fever (temperature measurement), Headache (1 to 4), Fatigue (1 to 4), Muscle pain (1 to 4), Skin rash (1 to 4), Vomiting (1 to 4), Diarrhea (1 to 4).~Record medication taken during the study (up to 7 months after the first vaccination).~The laboratory parameters analysed at day 10, 30, 40, 60, 180, and 210 are:~Hematology: Hematocrit, Hemoglobin, RBC count, WBC count, Platelet count, Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes. Biochemistry: Creatinine, Albumin, Alkaline Phosphatase, Total Bilirubin, ALT (GPT), AST (GOT), Gamma-Gt, C-Reactive Protein, and TSH/FT4.~Urinalysis (day 10, 40, and 210): Clarity, Color, Specific gravity, Leukocytes, Nitrite, pH, Erythrocytes, Albumin, and Glucose."|Up to 7 months after first vaccination|RCT: 27 participants screened, 3 excluded: 1 with LFTs abnormalities, 1 anti-HBs titre >10 mIU/mL, 1 suspected Cushing’s syndrome. 24 included. Open-Label: 10 screened and included.|||Participants|||Count of Participants
2569532|NCT02540538|Primary|Subjects With Local and/or General Adverse Events Irrespective of Severity|"Subjects will be given a diary for 4 days after the first and second vaccination.~Dairy: Local reactions at injection site: Pain (1 to 4), Impaired movement of injected arm (1 to 4), Redness/erythema (cm), Swelling (cm), Induration (cm) General/Systemic adverse events: Fever (temperature measurement), Headache (1 to 4), Fatigue (1 to 4), Muscle pain (1 to 4), Skin rash (1 to 4), Vomiting (1 to 4), Diarrhea (1 to 4).~Record medication taken during the study (up to 7 months after the first vaccination)."|Up to 7 months after first vaccination.|RCT: 27 participants screened, 3 excluded: 1 with LFTs abnormalities, 1 anti-HBs titre >10 mIU/mL, 1 suspected Cushing’s syndrome. 24 included. Open-Label: 10 screened and included.|||Participants|||Count of Participants
2569533|NCT02540447|Secondary|3 Months Mortality|mortality within first 3 post-operative months|3 Months||||participants|||Number
2569534|NCT02540447|Secondary|Post-operative Infectious Complications||30 days||||participants|||Number
2569535|NCT02540447|Secondary|Ischemia Reperfusion Injury|incidence of ischemia reperfusion injury in the transplanted graft|7 days||||participants|||Number
2569536|NCT02540447|Secondary|Biliary Complications (Participants)|Participants who developed biliary complications in three months period (Participant)|3 months||||participants|||Number
2569537|NCT02540447|Primary|Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure|The lowest of three recorded mean arterial pressure readings at 1,3 and 5 minutes after portal declamping|5 minutes post-reperfusion||||mmHg||Standard Deviation|Mean
2569538|NCT02540434|Secondary|Time to Product Administration|Time from request to administration of study product. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment.|Procedure length, the average for participants is approximately 6 hours|Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment||||||
2569539|NCT02540434|Secondary|Correlation of Laboratory and ROTEM Data|Correlation of fibrinogen, von Willebrand Factor (vWF), and factor VIII levels measured in traditional lab with intraoperative ROTEM parameters. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment.|Procedure length, the average for participants is approximately 6 hours|Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment||||||
2569540|NCT02540434|Secondary|Mortality Rate|Rate of hospital death during initial hospital admission. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment|Length of Hospital Stay, the average for participants is approximately 7 days|Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment||||||
2569590|NCT02540226|Secondary|Levels of Tranexamic Acid||Intraoperative (before cementing), 1 hour after tourniquet release (TQR), 4 hours after tourniquet release(TQR)|Blood was collected from the A-Line or CostaVac Drain. If no drain was placed, the wound 4 hour post TQR blood could not be collected.|||mg/L||Standard Deviation|Mean
2569541|NCT02540434|Secondary|Incidence of Re-exploration|Incidence of subjects requiring a return to the OR for re-exploration. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment.|Length of Hospital Stay, the average for participants is approximately 7 days|Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment||||||
2569542|NCT02540434|Secondary|Blood Loss|Quantity of intraoperative and postoperative blood loss as recorded in the anesthesia record and in chest tube outputs (blood drainage volume). Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment.|Length of Hospital Stay, the average for participants is approximately 7 days,|Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment||||||
2569543|NCT02540434|Secondary|Infection and Respiratory Failure|Incidence of any infection or respiratory failure from procedure end to hospital discharge. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment.|Length of Hospital Stay, the average for participants is approximately 7 days|Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment||||||
2569544|NCT02540434|Secondary|Thrombosis and Transfusion Reactions|Incidence of intraoperative or postoperative (during hospital admission only) thrombosis (symptomatic only) and transfusion reactions from procedure to hospital discharge. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment.|Length of Hospital Stay, the average for participants is approximately 7 days|Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment||||||
2569545|NCT02540434|Secondary|Hospital Length of Stay|Number of days subject spends in the hospital from procedure end to hospital discharge. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment.|Length of Hospital Stay, the average for participants is approximately 7 days|Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment||||||
2569546|NCT02540434|Secondary|CTICU Length of Stay|Number of days subject spends in cardiothoracic intensive care unit from procedure end to hospital discharge. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment|Length of Hospital Stay, the average for participants is approximately 7 days|Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment||||||
2569547|NCT02540434|Secondary|Correction of Microvascular Bleeding|Difference in surgeon's assessment of microvascular bleeding from approximately 15 minutes before to approximately 15 minutes after administration of study medication. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment|~30 min intraoperatively|Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment||||||
2569548|NCT02540434|Secondary|Incidence of Zero Transfusions|Number of patients who receive no allogeneic blood transfusions following study product administration and first 24 hours after procedure end. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment|24 hours|Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment||||||
2569549|NCT02540434|Secondary|Fibrinogen Repletion|Fibrinogen repletion as measured by ROTEM FIBTEM >10mm after study product administration. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment|Procedure length, the average for participants is approximately 6 hours|Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment||||||
2569550|NCT02540434|Secondary|24-hour Blood Transfusion Total|Number of units of RBC, Platelets, cryoprecipitate, FFP, or other blood products administered to subjects receiving study product within the first 24 hours after procedure end|24 hours|Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment||||||
2569551|NCT02540434|Primary|Intraoperative Blood Transfusion Total|The combined number of allogeneic blood products (platelets + Fresh Frozen Plasma (FFP) + RBCs) administered to subjects intraoperatively after study intervention.|Procedure length, the average for participants is approximately 6 hours|Only 2 subjects out of total enrolled were randomized. Due to this only 2 subjects being randomized and the study being terminated before completion, no data analysis was done to assess the primary outcome. Therefore there is no measurable data for the mean and SD in either arm.||||||
2569552|NCT02540356|Secondary|Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Questionnaire|QoL will be assessed using EORTC QLQ-C30.|Weekly from the baseline visit to the last week of safety follow-up (8 weeks or longer, if additional treatment will be implemented)|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
2569553|NCT02540356|Secondary|Imalumab (BAX69) Plasma Pharmacokinetic (PK) Parameter: Volume of Distribution (V)||Predose; and post-dose at 1.5, 4, 8, 24, and 72 hours|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
2569554|NCT02540356|Secondary|Imalumab (BAX69) Plasma Pharmacokinetic (PK) Parameter: Apparent Systemic Clearance (CL)||Predose; and post-dose at 1.5, 4, 8, 24, and 72 hours|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
2569555|NCT02540356|Secondary|Imalumab (BAX69) Plasma Pharmacokinetic (PK) Parameter: Half-life (t1/2)||Predose; and post-dose at 1.5, 4, 8, 24, and 72 hours|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
2569717|NCT02538419|Secondary|SEMSA - Outcome Expectations|Self Efficacy Measure for Sleep Apnea - Outcome Expectations. The SEMSA contains three sub-scales, each scored on a scale of 1 to 4. A higher score indicates a higher degree of outcome expectations associated with treatment of sleep apnea.|6 weeks||||units on a scale||Standard Deviation|Mean
2569556|NCT02540356|Secondary|Imalumab (BAX69) Plasma Pharmacokinetic (PK) Parameter: Area Under the Concentration vs Time Curve (AUC)||Predose; and post-dose at 1.5, 4, 8, 24, and 72 hours|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
2569557|NCT02540356|Secondary|Imalumab (BAX69) Plasma Pharmacokinetic (PK) Parameter: Minimum Observed Concentration (Cmin)||Predose; and post-dose at 1.5, 4, 8, 24, and 72 hours|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
2569558|NCT02540356|Secondary|Imalumab (BAX69) Plasma Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)||Predose; and post-dose at 1.5, 4, 8, 24, and 72 hours|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
2569559|NCT02540356|Secondary|Occurrence of Binding and/or Neutralizing Anti-imalumab (BAX69) Antibodies Following Treatment With Imalumab (BAX69)||Throughout the study period of approximately 22 months|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
2569560|NCT02540356|Secondary|Occurrence of Serious Adverse Events (SAEs) and/or Treatment-emergent Adverse Events (TEAEs), Regardless of Causality or Relationship to Study Drug||Throughout the study period of approximately 22 months|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure.|||Participants|||Count of Participants
2569561|NCT02540356|Secondary|Changes in Ascites-related Symptoms|Ascites related symptoms: anorexia, nausea, early satiety, vomiting, abdominal pain, abdominal swelling, dyspnea, fatigue, swollen ankles, heartburn|Baseline, weekly during the treatment period, and every 2 weeks during the safety follow-up period, up to approximately 6 months)|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
2569562|NCT02540356|Secondary|Change in Ascites Volume Per Unit Time With Treatment|The volume of ascites from the last dose of Imalumab to the first post-treatment paracentesis per unit time will be compared to the volume of the last pre-treatment paracentesis per unit time. At each paracentesis, the volume of fluid that can be removed safely (measured by ultrasound-guided paracentesis) to achieve close to dryness should be withdrawn, measured, and documented.|Up to 4 weeks|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
2569563|NCT02540356|Secondary|Ratio of Time to First Paracentesis Post-treatment Over Puncture-free Interval at Baseline|Time to first paracentesis post-treatment is calculated as the time between the last dose of Imalumab to subsequent first therapeutic paracentesis.|4 weeks|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
2569564|NCT02540356|Primary|The Ratio of Puncture Free Survival (PuFS) Over Puncture-free Interval at Baseline|"PuFS is defined as the time from the last dose of Imalumab to the first therapeutic paracentesis after that, or death, whichever occurs first.~Puncture-free interval at baseline is calculated as the time between the last 2 therapeutic paracenteses immediately before the first dose of Imalubmab."|4 weeks|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure. Additionally, due to concerns that the participant would be at risk of being re-identified, study results are not posted.||||||
2569565|NCT02540356|Primary|The Occurrence of Dose-limiting Toxicity (DLT)|"DLT is defined as any drug related treatment-emergent adverse event that occurs during the 28-day period after the first dose of Imalumab and that meets any of these criteria:~Any ≥ grade 3 non-hematologic toxicity assessed by the investigator as related to study drug (except: single lab value out of normal range not necessarily translating or considered a feature of clinical diagnosis requiring an intervention per investigator's interpretation and resolves to ≤ Grade 2 with adequate measure in 7 days; Transient grade 3 elevations of hepatic transaminases in the absence of simultaneous increase in serum bilirubin; Alopecia)~Any toxicity resulted in dose delay for ≥14 days~Any grade 4 hematologic toxicity (except lymphopenia)~Grade 3 febrile neutropenia~Grade 3 thrombocytopenia associated with bleeding~Any life-threatening complication/abnormality not covered in the NCICTCAE v4.03"|4 weeks|Study was terminated early with only one participant dosed. No statistical analysis was performed on this outcome measure.|||Participants|||Count of Participants
2569566|NCT02540291|Secondary|Clinical Benefit Rate (CBR)|The CBR is the percentage of participants achieving irPR + irCR + irSD (lasting at least 24 weeks), according to irRECIST v1.1 from first dose date until disease progression/recurrence.|From first dose date until disease progression/recurrence (approximately up to 2 years)|The FAS included all participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2569567|NCT02540291|Secondary|Disease Control Rate (DCR)|The DCR is percentage of participants achieving best overall response of confirmed irCR, irPR, or immune-related stable disease (irSD) (lasting at least 5 weeks), according to irRECIST v1.1 from the first dose date until disease progression/recurrence.|From the first dose date until disease progression/recurrence (approximately up to 2 years)|The FAS included all participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2569568|NCT02540291|Secondary|Duration of Response (DOR)|The DOR is defined as the time from the date of first documented confirmed irCR/irPR, according to irRECIST v1.1 until the first documentation of confirmed disease progression or death, whichever came first.|From the date of first documented confirmed irCR/irPR until the first documentation of confirmed disease progression or death (approximately up to 2 years)|The FAS included all participants who received at least 1 dose of study drug. No participants had irCR or irPR; therefore, the DOR could not be determined.||||||
2569569|NCT02540291|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from first dose date to the date of the first documentation of confirmed disease progression or death, whichever occurs first, according to irRECIST v1.1. PFS was calculated using Kaplan-Meier product-limit method and Greenwood Formula.|From first dose date to the date of the first documentation of confirmed disease progression or death (approximately up to 2 years)|The FAS included all participants who received at least 1 dose of study drug.|||months||95% Confidence Interval|Median
2569570|NCT02540291|Secondary|Objective Response Rate (ORR)|The ORR is the percentage of participants achieving a best overall response of confirmed immune-related partial response (irPR) + immune-related complete response (irCR), according to immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) v1.1, from first dose date until disease progression/recurrence.|From first dose date until disease progression/recurrence (approximately up to 2 years)|The FAS included all participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2569571|NCT02540291|Primary|Recommended Phase 2 Dose (RP2D) of E7046|Two RP2Ds were planned to be evaluated.|Cycle 1 (21 days)|The DLT evaluable set included all participants who were evaluable for the DLTs and had taken at least 1 dose of E7046.|||mg|||Number
2569572|NCT02540291|Primary|Maximum Tolerated Dose (MTD) of E7046||Cycle 1 (21 days)|The dose limiting toxicity (DLT) evaluable set included all participants who were evaluable for the DLTs and had taken at least 1 dose of E7046.|||mg|||Number
2569573|NCT02540291|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 2 years)|The FAS included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2569574|NCT02540265|Secondary|Number of Subjects With Use of Rescue Medication (Oral Opioids)||48 hours|mITT analysis set|||Participants|||Count of Participants
2569575|NCT02540265|Secondary|Summed Pain Intensity Difference (SPID) at Other Intervals|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID was better.|48 Hours|mITT analysis set|||units on a scale||Standard Error|Least Squares Mean
2569576|NCT02540265|Secondary|Summed Pain Intensity Difference Over the First 48 Hours (SPID48)|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID was better.|48 Hours|mITT analysis set|||units on a scale||Standard Error|Least Squares Mean
2569577|NCT02540265|Secondary|Effect Size of N1539 Doses Using the Summed Pain Intensity Difference Over the First 48 Hours (SPID48)|Effect size was estimated based on SPID48 derived using 2-hour windowed last observation carried forward (W2LOCF) method and an analysis of covariance (ANCOVA) model that included treatment and baseline PI score.|48 Hours|All subjects treated with ≥1 dose of study medication and who had baseline PI and at least one post baseline PI (mITT analysis set; efficacy analysis set)|||units on a scale||Standard Error|Least Squares Mean
2569578|NCT02540265|Primary|Number of Subjects With Adverse Events|Number of subjects reporting treatment emergent adverse events|Through Day 30 Follow-up|All subjects treated with ≥1 dose of study medication (Safety analysis set)|||Participants|||Count of Participants
2569579|NCT02540226|Secondary|Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation in Wound Blood|The values for the wound blood levels are given as the count of patients who had a level above the threshold of >3600 pmol/L.|Intraoperative, 4 hour post Tourniquet Release (TQR)|Blood samples could not be collected at the 4-hour post tourniquet release for some patients.|||Participants|||Count of Participants
2569580|NCT02540226|Secondary|Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis|Levels of PAP will be measured in peripheral blood and wound drainage|Intraoperative, 1 hour post Tourniquet Release (TQR)||||mg/L||Standard Deviation|Mean
2569581|NCT02540226|Secondary|Levels of IL-6 in Blood||Intraoperative, 1 hour post Tourniquet Release (TQR), 4 hour post Tourniquet Release (TQR)||||pg/mL||Standard Deviation|Mean
2569582|NCT02540226|Secondary|Length of Hospital Stay||Length of Hospital Stay||||days||Full Range|Median
2569583|NCT02540226|Secondary|Time to Physical Therapy Discharge||During Hospital Stay||||days||Inter-Quartile Range|Median
2569584|NCT02540226|Secondary|Patients Who Had 1 Unit of Blood Transfusion Administered||Duration of inpatient hospital stay (average of 3 days)||||Participants|||Count of Participants
2569585|NCT02540226|Secondary|Incidence of Thrombosis (DVT/PE)||Postoperative day 14 (2 weeks after surgery)||||Participants|||Count of Participants
2569586|NCT02540226|Secondary|Constavac Blood Drainage|A wound drain is connected to a Constavac system, which postoperatively collects, filters, and allows for reinfusion of the patient's own blood. Shed blood passes through an internal prefilter and is collected in a reservoir.|4 hours after tourniquet release|Some patients did not get a contavac drain put in hence the discrepancy in analysis population description.|||mL||Inter-Quartile Range|Median
2569587|NCT02540226|Secondary|Levels of Hematocrit||1 hour after tourniquet release, POD 1, POD 2|The number in one or more rows differs from overall number analyzed because patients were either discharged early or there was a missing blood draw.|||% of red blood cells in blood||Standard Deviation|Mean
2569588|NCT02540226|Secondary|Levels of Hemoglobin||1 hour after tourniquet release, POD 1, POD 2|The number in one or more rows differs from overall number analyzed because patients were either discharged early or there was a missing blood draw.|||g/dL||Standard Deviation|Mean
2569591|NCT02540226|Secondary|Levels of Prothrombin Fragment 1.2 (PF1.2) - Marker of Thrombin Generation|Systemic PAP blood level measured at the following time points - Intraoperative - Before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release|before cementing, 1 hour after tourniquet release, 4 hours after tourniquet release||||pmol/L||Standard Deviation|Mean
2569592|NCT02540226|Primary|Levels of Plasmin Anti-plasmin (PAP) - Marker of Fibrinolysis|Levels of PAP will be measured in peripheral blood and wound drainage at 4 hours after tourniquet release.|4 hours after tourniquet release|A wound drain was not inserted in all patients - hence why wound blood was not able to be collected 4 hours post tourniquet release.|||ug/L||Standard Deviation|Mean
2569593|NCT02540213|Primary|Percentage of Participants With Pre-Post Shift for Participant Satisfaction With Treatment|Participant satisfaction with treatment was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Participant pre-post comparison of satisfaction rating was done by considering the difference of baseline rating (satisfaction rating for previous ESA) and rating at respective visit (satisfaction rating for MIRCERA). Thus, possible results were -2, -1, 0, 1, and 2, with positive values indicating a greater satisfaction with MIRCERA than with the previous ESA (acceptance and preference of MIRCERA over previous ESA). Percentage of participants with each possible result category (-2, -1, 0, 1, 2) is reported at each visit.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9|Participant Satisfaction Set. Here, n = participants evaluable for specified timeframe.|||percentage of participants|||Number
2569594|NCT02540213|Primary|Mean Monthly Administrations of MIRCERA||9 months|Efficiency Set included all participants who had at least one MIRCERA application, without any major protocol violation and had prescription and application data available for 2 months before start of MIRCERA and first 2 months of study. Here N = participants who were evaluable for this outcome measure.|||MIRCERA administrations per month||Standard Deviation|Mean
2569595|NCT02540213|Primary|Number of MIRCERA Dose Adaptations||9 months|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.|||dose adaptations||Standard Deviation|Mean
2569596|NCT02540213|Primary|Average Monthly Dose of MIRCERA||9 months|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.|||grams||Standard Deviation|Mean
2569597|NCT02540213|Primary|Percentage of Participants Who Continued Treatment After End of Study||End of observation period (Month 9)|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2569598|NCT02540213|Primary|Percentage of Participants Who Reported Easement of Therapy With MIRCERA||9 months|Participant Satisfaction Set.|||percentage of participants|||Number
2569599|NCT02540213|Primary|Change From Baseline in Pain Sensation Using Visual Analogue Scale|Pain sensation was reported by participants using a visual scale ranging from 0 (no pain) to 10 (strong pain). Pain sensation at baseline referred to pain sensation regarding previous ESA. Change of pain sensation = pain sensation regarding previous ESA (baseline)' minus 'pain sensation regarding MIRCERA (Month 1-9). Positive numbers indicate less pain sensation during MIRCERA application.|Baseline, Months 1-9|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure and n = participants evaluable for specified timeframe.|||units on a scale||Standard Deviation|Mean
2569600|NCT02540213|Secondary|Change From Baseline in Hemoglobin (Hb) Concentration||Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9|Secondary endpoint set included all participants who had at least one MIRCERA application, without any major protocol violation and had at least 6 months documentation and minimum 2 of the 3 visits non-missing Hb and dosing data from Month 7 to 9 visits. N=participants evaluable for this outcome and n=participants evaluable for specified timeframe.|||g/dL||Standard Deviation|Mean
2569601|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 9|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 9|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2569602|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 8|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 8|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2569603|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 7|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 7|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2569604|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 6|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 6|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2569605|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 5|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 5|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2569606|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 4|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 4|Participant Satisfaction Set. Here N = participants who were available for this outcome measure.|||percentage of participants|||Number
2569607|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 3|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 3|Participant Satisfaction Set. Here N = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2569608|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 2|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 2|Participant Satisfaction Set. Here number of participants analyzed (N) = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2569609|NCT02540213|Primary|Percentage of Participants Satisfied With the MIRCERA Treatment, Application, Preparation, Storage, and Disposal at Month 1|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non-satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) was reported for each of the MIRCERA parameters.|Month 1|Participant Satisfaction Set.|||percentage of participants|||Number
2569610|NCT02540213|Primary|Percentage of Participants Satisfied With Previous Erythropoiesis Stimulating Agent (ESA) Treatment|Participant satisfaction was measured using 3 categories (1=satisfying, 2=undecided, 3=non- satisfying). Percentage of participants who were satisfied (with a rating of 1 [satisfying]) with previous ESA treatment was reported. For participants who had multiple previous ESA treatments, the latest applied ESA before start of Mircera therapy was considered.|Baseline|Participant Satisfaction Set included all participants who had at least one MIRCERA application, without any major protocol violation and had satisfaction rating documented for previous ESA and MIRCERA.|||percentage of participants|||Number
2569611|NCT02540083|Other Pre-specified|Safety - Device Related Malfunctions|Number of device-related malfunctions by imaging modality.|Approximately 8 weeks|All enrolled participants|||malfunctions|||Number
2569612|NCT02540083|Secondary|Biopsy Finding of Lesions|Describes histologic cancer and non-cancer findings of lesion biopsy.|Approximately 8 weeks|All participants who completed the study.|||Participants|||Count of Participants
2569613|NCT02540083|Secondary|Lesion Size as Observed by DBT|Length of lesions (measured in mm) when images were collected using DBT.|Approximately 8 weeks|Lesions observed and measured when images were collected using DBT|||millimeters (mm)|lesions|Full Range|Mean
2569614|NCT02540083|Secondary|Lesion Size as Observed by FFDM|Length of Lesions (measured in mm) when images were collected using FFDM.|Approximately 8 weeks|Lesions as observed by FFDM|||millimeters (mm)|Lesions|Full Range|Mean
2569615|NCT02540083|Secondary|Lesion Type Observed by DBT Imaging|Lesions were characterized based on findings identified during image evaluations performed by qualified researchers.|Approximately 8 weeks|Lesions observed using DBT|||lesions|lesions||Count of Units
2569616|NCT02540083|Secondary|Lesion Type Observed by FFDM Imaging|Lesions were characterized based on findings identified during image evaluations performed by qualified readers.|Approximately 8 weeks|Lesions observed using FFDM imaging|||Lesions|Lesions||Count of Units
2569617|NCT02540083|Primary|Number of Participants With DBT, FFDM and Biopsy Specimens Collected|For each participant, obtain image data using two methods (DBT and FFDM) and obtain histology results of biopsy specimens from women referred for biopsy.|Approximately 8 weeks|Total number of participants enrolled.|||Participants|||Count of Participants
2569618|NCT02539992|Secondary|Assessment of Better Performance of TKR Using a Kinematic Aligned ShapeMatch Cutting Guide by Functional Evaluation With Knee Society Score (KSS).|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, Range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.|||units on a scale||Standard Deviation|Mean
2569619|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36).|The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.|||units on a scale||Standard Deviation|Mean
2569620|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).|"The EQ-5D index has an upper bound equal to 1 that indicates full health (indicated by no problem in all domains), whereas 0 represents death. Negative values are allowed, and the lower bound varies depending on country-specific value set used. UK time Trade Off (UKTTO) indicates the patient status compared to the normal state of the UK population."|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.|||units on a scale||Standard Deviation|Mean
2569621|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the Forgotten Joint Score (FJS) Patient Questionnaire.|The FJS consists of 12 questions and focuses on the patients' awareness of their joint replacement during a range of day to day and recreational activities. The score has a range of 0-100. High scores indicate good outcome, i.e., a high degree of being able to forget about the affected joint in daily life.|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.|||units on a scale||Standard Deviation|Mean
2569660|NCT02539368|Primary|Number of Participants Who Switched Treatment|Here, number of participants with either UC or CD, who switched from remicade to CT-P13; switched from CT-P13 to remicade and multiple switchers were reported.|From baseline to follow-up period (up to a maximum duration of 2 years)|Safety analysis population included all participants who received at least 1 dose of study drug during the observation period.|||Participants|||Count of Participants
2569622|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.|KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).|1 year follow-up|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.|||units on a scale||Standard Deviation|Mean
2569623|NCT02539992|Secondary|Investigation of Clinical Performance and Patient Outcome With the Get-up and go Test|"Get-up-and-go test uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.~One source suggests that scores of ten seconds or less indicate normal mobility, 11 - 20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls."|1 year|Due to early study termination, there was limited data available for analysis and therefore insufficient power to provide robust, meaningful results for our primary or secondary analysis.|||seconds||Standard Deviation|Mean
2569624|NCT02539992|Primary|Assessment of Better Functional Performance of Total Knee Replacement (TKR) Using a Kinematic Aligned ShapeMatch Cutting Guide by Means of Fluoroscopy.|To demonstrate by means of fluoroscopy that TKR's performed using a kinematic aligned ShapeMatch Cutting Guide provides better short term kinematic and functional performance compared to those TKR's performed with ShapeMatch cutting guides modified to provide neutral overall limb alignment or with conventional instrumentation intended to achieve neutral overall limb alignment.|6 months|Early study termination resulted in limited availability of data for analysis to provide robust, meaningful results. Therefore the fluoroscopic data sets of the Neutral Overall Limb Alignment and Conventional Limb Alignment groups were combined and compared with the Kinematic Alignment group.|||Degrees||Standard Deviation|Mean
2569625|NCT02539797|Primary|Change From Baseline in Managing Emotions on MSCEIT|Total score on the Managing Emotions component of Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) The test consists of 141 items and 8 ability subtests, which assess four components of emotional processing. In this study, only branches 1 and 4 were administered, focusing on the Managing Emotions component. The total score reflects mean performance across the branches. The scores were converted to normed T-scores that have a mean of 50, with a difference of 10 points from the mean equaling one standard deviation. Higher T-scores are indicative of better performance.|baseline and 20 minutes||||T-scores||Standard Error|Mean
2569626|NCT02539797|Primary|Change From Baseline in Cognition on MCCB|Summary score of the cognitive domains on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB). Four nonsocial neurocognitive tasks were included: speed of processing, working memory, verbal memory, and reasoning/problem solving. Normed T-scores were calculated for each cognitive subdomain, as well as the cognitive composite score consisting of the average across the four subdomains. The T-scores have a mean of 50, with a difference of 10 points from the mean equaling one standard deviation. Higher T-scores are indicative of higher cognition.|baseline and 20 minutes||||T-scores||Standard Error|Mean
2569627|NCT02539654|Primary|Terminal Elimination Half-life (T1/2)|Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.|Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose|PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte [EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)]|||hours||Standard Deviation|Mean
2569628|NCT02539654|Primary|Time to Last Measurable Concentration (Tlast)|Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.|Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose|PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte [EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)]|||hours||Full Range|Median
2569629|NCT02539654|Primary|Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf)|Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.|Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose|PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte [EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)]|||ng*h/mL||Standard Deviation|Mean
2569630|NCT02539654|Primary|Area Under the Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point (AUC0-last)|Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.|Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose|PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte [EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)]|||ng*h/mL||Standard Deviation|Mean
2569631|NCT02539654|Primary|Time to Reach Maximum Concentration (Tmax)|Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.|Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose|PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte [EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)]|||hours||Full Range|Median
2569632|NCT02539654|Primary|Maximum Analyte Plasma Concentration (Cmax)|Based on serum samples collected at pre-determined nominal time points, dependent on observed concentrations. EXE844 (AL-60371) concentration values below the lower limit of quantification (<0.05 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics. Similarly for EXE844 glucuronide metabolite (AL-91591), concentration values below the lower limit of quantification (<0.5 ng/mL) were replaced by one-half the lower limit of quantification in the calculation of the summary statistics.|Day 1, pre-dose 0 hour (up to 30 minutes prior to dose), 0.5, 1, 2, 4, 6 hours post-dose|PK analysis set, with at least 1 post-dose quantifiable plasma concentration for each individual analyte [EXE844 (AL-60371) and EXE844 glucuronide metabolite (AL-91591)]|||ng/mL||Standard Deviation|Mean
2569633|NCT02539563|Post-Hoc|Cervical Dilation|rate in centimeters per hour of dilation|length of labor, up to 24 hours|rate of cervical dilation in centimeters per hour that subjects dilated in each group|||centimeters per hour||Standard Deviation|Mean
2569634|NCT02539563|Secondary|Number of Participants With Post-delivery Complications|Number of participants that had post-delivery complications was reported|up to 24 hours||||Participants|||Count of Participants
2569635|NCT02539563|Secondary|Participant Cesarean Delivery Incidence-Mode of Deliveries|the number of subjects who had to had a cesarean delivery|up to 24 hours||||number of cesarean deliveries|||Number
2569636|NCT02539563|Secondary|Maternal Satisfaction|11-point scale of 0=not satisfied up to 10=most satisfied of all|length of labor, up to 24 hours||||units on a scale||Standard Deviation|Mean
2569637|NCT02539563|Primary|Length of Labor|time in minutes will be calculated from epidural catheter insertion until delivery|up to 24 hours||||minutes||Standard Deviation|Mean
2569638|NCT02539511|Primary|Percentage of Participants Demonstrating Alcohol Abstinence in the Control (Midazolam) Group Versus the Active (Ketamine) Group|Percentage of participants demonstrating alcohol abstinence in the control (midazolam) group versus the active (ketamine) group|21 days post-infusion|Medically healthy, treatment-seeking adults without psychiatric comorbidity and who met DSM-IV criteria for alcohol dependence and minimum use criteria.|||percentage of participants|||Number
2569639|NCT02539368|Secondary|Number of Participants With Imaging Test Results|Number of participants who had Imaging test results related to the treatment or assessment of Crohn's Disease or Ulcerative Colitis were reported.|From baseline up to follow-up period (a maximum of 2 years)|FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to treatment or assessment of CD or UC).|||Participants|||Count of Participants
2569640|NCT02539368|Secondary|Mean Change From Baseline in Laboratory Test Results: Fecal Calprotectin at Months 6, 12, 18, and 24|Here, the laboratory tests related to the treatment or assessment of Crohn's Disease or Ulcerative Colitis was fecal calprotectin.|Baseline, Months 6, 12, 18, and 24|FAS=all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to treatment or assessment of CD or UC). Here, Number analyzed =participants evaluable at specified time points for each arm.|||milligram per kilogram (mg/kg)||Standard Deviation|Mean
2569641|NCT02539368|Secondary|Mean Change From Baseline in Laboratory Test Results: C-Reactive Protein at Months 6, 12, 18, and 24|C-reactive protein (CRP) was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicated reduction in inflammation and therefore improvement.|Baseline, Months 6, 12, 18 and 24|FAS=all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to treatment or assessment of CD or UC). Here, Number analyzed =participants evaluable at specified time points for each arm.|||milligram per liter (mg/L)||Standard Deviation|Mean
2569642|NCT02539368|Secondary|Crohn's Disease: Number of Participants Categorized on the Basis of Fistula Drainage Assessment Index|The fistula drainage assessment index was used to assess the improvement or remission of the disease activity of Crohn's Disease, based on 6 categories: remission (remission was defined as closure of all fistulae that were draining at baseline for at least two consecutive visits); improvement (improvement defined as a decrease from baseline in the number of open draining fistulae of 50% for at least two consecutive visits); worsened; unchanged; not accessible and missing disease activity.|Baseline, Months 6, 12, 18 and 24|FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.|||Participants|||Count of Participants
2569643|NCT02539368|Secondary|Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Severity|The Montreal classification index for UC was used to classify the extent and severity of the disease activity. UC can be classified broadly into four disease activity/severity categories: Severity 0 (S0) = asymptomatic clinical remission; Severity 1 (S1) = Mild UC (passage of four or fewer stools/day [with or without blood], absence of any systemic illness, and normal inflammatory markers); Severity 2 (S2) = Moderate UC (passage of more than four stools per day but with minimal signs of systemic toxicity) and Severity 3 (S3) = Severe UC (passage of at least six bloody stools daily).|Baseline, Months 6, 12, 18 and 24|FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.|||Participants|||Count of Participants
2569644|NCT02539368|Secondary|Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Extent|The Montreal classification index for Ulcerative Colitis (UC) was used to classify the extent and severity of the disease activity. There were three subgroups of UC defined by extent: Extent 1 (E1) =Ulcerative proctitis, Extent 2 (E2) =Left-sided UC and Extent 3 (E3) =Extensive UC.|Baseline, Months 6, 12, 18 and 24|FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.|||Participants|||Count of Participants
2569645|NCT02539368|Secondary|Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Behavior of the Disease Activity|The Montreal classification index for CD was used to classify the extent of the disease activity. It consists of two parameters: location and behavior of the disease activity. There were 4 different categories for the behavior of the disease activity: Behaviour 1 (B1) was nonstricturing (NS), nonpenetrating (NP); Behaviour 2 (B2) was structuring; Behaviour 3 (B3) was penetrating and p as perianal disease (p). The first 3 categories (B1 to B3) could be added with p to indicate coexisting perianal disease. Perianal disease (p) was defined as the presence of perianal abscesses or fistulae.|Baseline, Months 6, 12, 18 and 24|FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.|||Participants|||Count of Participants
2569646|NCT02539368|Secondary|Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Location|The Montreal classification index for CD was used to classify the extent of the disease activity. It consisted of three parameters: age at diagnosis, location and behavior of the disease activity. There are four different disease locations presented: Location 1 (L1) is terminal ileum, Location 2 (L2) is colon, Location 3 (L3) is ileocolon and Location 4 (L4) is upper gastrointestinal (GI). The first three categories (L1-L3) was combined with L4 where disease sites coexisted.|Baseline, Months 6, 12, 18 and 24|FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.|||Participants|||Count of Participants
2569647|NCT02539368|Secondary|Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Age at Diagnosis|The Montreal classification index for CD was used to classify the extent of the disease activity. It consisted of three parameters: age at diagnosis, location and behavior of the disease activity. There were four different age groups categorized: 16 years or younger, 17-40 years, over 40 years and missing.|At Baseline|FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified rows for each arm.|||Participants|||Count of Participants
2569648|NCT02539368|Secondary|Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Disease Activity|Mayo Score is an instrument to measure disease activity of UC. Score ranges from 0 to 12 points. It consists of 4 sub scores, each graded from 0 to 3. Higher scores= more severe disease. A Partial Mayo Score (PMS) (Mayo score without endoscopy) is comprised of 3 parameters: stool frequency ranging from 0 (normal number of stools) to 3 (having >=5 stools more than normal), the presence of rectal bleeding ranging from 0 (no blood seen) to 3 (blood alone passes), and physician's global assessment ranging from 0 (normal) to 3 (severe disease). The total partial Mayo score was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease. The score was calculated if data were available for at least 1 of 3 Mayo sub scores. The level of disease activity was interpreted as clinical remission (CR) (PMS <2), mild disease (MD) (PMS=2 to 4), moderate disease (Mod D) (PMS=5 to 6) and severe disease (SD) (PMS >6).|Baseline, Months 6, 12, 18 and 24|FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.|||Participants|||Count of Participants
2569649|NCT02539368|Secondary|Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Clinical Remission|Mayo Score is an instrument to measure disease activity of UC. Score ranges from 0 to 12 points. It consists of 4 sub scores, each graded from 0 to 3. Higher scores = more severe disease. A Partial Mayo Score (PMS) (Mayo score without endoscopy) is comprised of 3 parameters: stool frequency ranging from 0 (normal number of stools) to 3 (having >=5 stools more than normal), the presence of rectal bleeding (ranging from 0=no blood seen to 3=blood alone passes), and physician's global assessment (ranging from 0=normal to 3=severe disease). The total partial Mayo score was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease. The score was calculated if data were available for at least 1 of 3 Mayo sub scores. The level of disease activity was interpreted as clinical remission (CR) (PMS <2), mild disease (MD) (PMS=2 to 4), moderate disease (Mod D) (PMS=5 to 6) and severe disease (SD) (PMS >6).|Baseline, Months 6, 12, 18 and 24|FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.|||Participants|||Count of Participants
2569657|NCT02539368|Primary|Number of Participants by Frequency of Infusion Received|Number of participants by infusion frequency (weeks) were reported at baseline and categorized as follows: once a week; once every 2 weeks; once every 3 weeks; once every 4 weeks; once every 5 weeks; once every 6 weeks; once every 7 weeks; once every 8 weeks and others. Here, 'Others' category included all the frequencies apart from the mentioned categories.|Baseline (Day 1)|Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.|||Participants|||Count of Participants
2569650|NCT02539368|Secondary|Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index According to Disease Activity|HBI is a simple index of CD activity. HBI measures 5 clinical parameters; the general well-being ranging from 0 (very well) to 4 (terrible), abdominal pain ranging from 0 (none) to 3 (severe), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam ranging from 0 (none) to 3 (definite and tender), and whether there are any complications ranging from 0=no complications, 1=Arthralgia; 2=Uveitis; 3=Erythema nodosum; 4=Aphthous ulcer; 5=Pyoderma gangrenosum; 6=Anal fissure; 7=New fistula and 8=abscess). The total HBI score is the sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends on the number of liquids stools. Higher HBI scores=greater disease activity. The level of disease activity was interpreted as clinical remission (CR) (HBI score < 5), mild disease (MD) (HBI score = 5 to 7), moderate disease (Mod D) (HBI score = 8 to 16) and severe disease (SD) (HBI score >16).|Baseline, Months 6, 12, 18 and 24|FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.|||Participants|||Count of Participants
2569651|NCT02539368|Secondary|Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Clinical Remission|HBI is a simple index of CD activity. HBI measures 5 parameters; the general well-being (ranging from 0=very well to 4=terrible), abdominal pain ranging from 0 (none) to 3 (severe), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam ranging from 0 (none) to 3 (definite and tender), and whether there are any complications ranging from 0=no complications, 1=Arthralgia; 2=Uveitis; 3=Erythema nodosum; 4=Aphthous ulcer; 5=Pyoderma gangrenosum; 6=Anal fissure; 7=New fistula and 8=abscess). The total HBI score is the sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends on the number of liquids stools. Higher HBI scores=greater disease activity. The level of disease activity was interpreted as clinical remission (CR) (score less than [<] 5), mild disease (MD) (score equal to [=] 5 to 7), moderate disease (Mod D) (score=8 to 16) and severe disease (SD) (score more than [>] 16).|Baseline, Months 6, 12, 18 and 24|FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.|||Participants|||Count of Participants
2569652|NCT02539368|Secondary|Number of Participants Remaining in Clinical Remission or Relapse|Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual sub score exceeding 1 point. Mayo score is an instrument designed to measure disease activity. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician's global assessment, each sub score graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease. The relapse of clinical remission was defined as the time from the date of first attaining CR to the date of relapse or death from any cause, whichever occurred first.|Months 6, 12, 18 and 24|Full analysis set (FAS)=all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to assessment of CD or UC).Number analyzed =participants evaluable at specified time points for each arm.|||Participants|||Count of Participants
2569653|NCT02539368|Primary|Number of Participants With Treatment-Emergent Adverse Event (AEs), Serious Adverse Events (SAEs) and Adverse Event With Special Interest (AESIs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of infusion up to month 24, that were absent before treatment or that worsened relative to pretreatment state. Hypersensitivity was the pre-defined TEAE of special Interest for this study. AEs included both serious and non-serious adverse events.|From baseline to follow-up period (up to a maximum duration of 2 years)|Safety analysis population included all participants who received at least 1 dose of study drug during the observation period.|||Participants|||Count of Participants
2569654|NCT02539368|Primary|Number of Participants Who Took Concomitant Medications Related to the Treatment of Crohn's Disease (CD) or Ulcerative Colitis (UC)||From baseline to follow-up period (up to a maximum duration of 2 years)|Safety analysis population included all participants who received at least 1 dose of study drug during the observation period.|||Participants|||Count of Participants
2569655|NCT02539368|Primary|Number of Participants Who Had Change in Infusion Dose Categorized Based on Reasons of Change|Participants who had change in infusion dose due to various reasons such as principal investigator's decision, participant's decisions, loss of response, lack of compliance, hypersensitivity, occurrence of adverse event (including adverse event special interest [AESI]/ serious adverse event [SAE]), positive for antibodies and other were reported. Here, 'Others' category included all reasons apart from the mentioned categories. A participant could have different reasons of dose change across visits, hence could be counted in more than one category.|From baseline to follow-up period (up to a maximum duration of 2 years)|Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.|||Participants|||Count of Participants
2569656|NCT02539368|Primary|Number of Participants Who Had Change in Infusion Dose|Participants who had change in the dose of infusion (either dose reduction or increase in dose) were included and reported.|From baseline to follow-up period (up to a maximum duration of 2 years)|Safety analysis population included all participants who received at least 1 dose of study drug during the observation period.|||Participants|||Count of Participants
2569658|NCT02539368|Primary|Total Dose of Infusion Received|Total dose of infusion received by the participants was calculated.|From baseline to follow-up period (up to a maximum duration of 2 years)|Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.|||milligram||Full Range|Median
2569661|NCT02539368|Primary|Disease Characteristics of Participants: Disease Duration|Disease duration was defined as the number of months from initial diagnosis of inflammatory bowel disease (CD or UC) to the date of informed consent, which was recorded at the time of enrollment into the study (baseline).|Baseline (Day 1)|Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.|||months||Full Range|Median
2569662|NCT02539342|Other Pre-specified|Tolerability of Four Times Daily Caphosol Therapy|Any adverse events attributable to caphosol therapy being given 4 times daily|24 months|1 patient enrolled on Caphosol and None on Control Arm|||events|||Number
2569663|NCT02539342|Primary|Measure the Development of Oral Mucositis (Grade >/= 2) in Children, Adolescents and Young Adults.|The development of Mucositis Grade >/= 2 in children receiving chemotherapy as evaluated using CTCAE 4.0|24 months|We only had 1 patient enrolled on the Caphosol Arm and none on the Control Arm|||Participants|||Count of Participants
2569664|NCT02539225|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|Participant is considered as treatment emergent anti-drug antibody (TE ADA) positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post baseline result of ADA Present with titer >= 20.|Baseline through 25 months|All randomized participants who received any quantity of study drug in part A and had at least one baseline & post baseline antibody (ADA) measurement.|||Participants|||Count of Participants
2569665|NCT02539225|Secondary|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part B|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part B.|Cycle 1 Day 1 predose, Cycle 2 Day 1 predose|All randomized participants who received at least one dose of ramucirumab in part B and had evaluable PK samples.|||Microgram per milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2569666|NCT02539225|Secondary|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part A|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part A.|Cycle 1 Day 1 & 8 Predose, Cycle 2 Day 1 Predose, Cycle 3 Day 1 Predose, Cycle 5 Day 1 Predose, Cycle 9 Day 1 Predose|All randomized participants who received at least one dose of ramucirumab in part A and had evaluable PK samples.|||Microgram per milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2569667|NCT02539225|Secondary|Disease Control Rate (DCR)|Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm or the appearance of ≥1 new lesions was progression.|Randomization to Disease Progression (Up to 25 Months)|All randomized participants who received any quantity of study drug in Part A with measurable disease.|||percentage of participants||80% Confidence Interval|Number
2569668|NCT02539225|Secondary|Percentage of Participants With Objective Response Rate (ORR)|The ORR is the number of all participants with Partial Response (PR) or Complete Response (CR) according to RECIST v1.1 from the start of the treatment until disease progression/recurrence. CR is defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR is defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm or the appearance of ≥1 new lesions was progression.|Randomization to Disease Progression (Up to 25 Months)|All randomized participants who received any quantity of study drug in Part A with measurable disease.|||percentage of participants||80% Confidence Interval|Number
2569669|NCT02539225|Secondary|Overall Survival (OS)|Overall survival is defined as time from the date of randomization to the date of death from any cause. If the patient was alive at the cut-off for analysis (or lost to follow-up), OS data were censored for analysis on the last date the patient was known to be alive.|Randomization to Death Due to Any Cause (Up to 31 Months)|All randomized participants who received at least one dose of study drug. Censored participants: Ramucirumab + S-1 + Oxaliplatin = 27; Placebo + S-1 + Oxaliplatin = 30.|||Months||80% Confidence Interval|Median
2569670|NCT02539225|Secondary|Progression-free Survival to the Second Disease Progression (PFS 2)|Progression-free survival 2 (PFS2) is defined as the time from the date of randomization to second disease progression (defined as the date of first tumor assessment observing PD defined by RECIST v.1.1, after the start of second-line therapy using the last tumor assessment before starting the second-line therapy (RAM+PTX) as the baseline assessment), or death of any cause, whichever occurs first. If the second-line therapy was not started, the OS will be substituted for PFS2. If a post-discontinuation therapy was started before observing PD after the start of second-line therapy. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. PFS2 will be censored at the date of the last adequate tumor assessment on or before staring the post-discontinuation therapy.|Randomization to Second Radiographic Documentation of Progression or Death Due to Any Cause (Up to 31 Months)|All randomized participants who received any quantity of study drug. Censored participants: Ramucirumab + S-1 + Oxaliplatin = 26; Placebo + S-1 + Oxaliplatin = 26.|||Months||80% Confidence Interval|Median
2569714|NCT02538471|Primary|Number of Participants Non-irradiated Tumor Lesions That Had a Response.|To determine if treatment with TGFΒ receptor I kinase inhibitor LY2157299 and localized RT achieves an abscopal tumor regression|Until next progression up to 3 years|Only 1 patient completed protocol therapy. 2 patients were removed from the study for disease progression.|||Participants|||Count of Participants
2569671|NCT02539225|Primary|Progression Free Survival (PFS)|PFS is defined as the time from the date of randomization until the date of objectively determined progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause, whichever is first. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 millimeter (mm) or the appearance of ≥1 new lesions was progression. Participants who did not progress, were lost to follow-up were censored at the day of their last adequate tumor assessment.|Randomization to Radiographic Documentation of Progression or Death Due to Any Cause (Up to 25 Months)|All randomized participants who received any quantity of study drug in Part A. Censored participants: Ramucirumab + S-1 + Oxaliplatin = 23; Placebo + S-1 + Oxaliplatin = 19.|||Months||80% Confidence Interval|Median
2569672|NCT02539134|Secondary|AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Over the Dosing Interval for TAK-935||Day 14: Pre-dose and at multiple time points (up to 24 hours for Cohorts 1, 2, 4, and 5; up to 12 hours for Cohort 3) post-dose|The PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration. No data was reported for Cohorts 3 and 4 since dosing was discontinued after Day 10.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2569673|NCT02539134|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935||Day 1: Pre-dose and at multiple time points (up to 24 hours for Cohorts 1, 2, 4, and 5; up to 12 hours for Cohort 3) post-dose|The PK set where Day 1 assessment for AUC∞ was available. The PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2569674|NCT02539134|Secondary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935||Day 1 and Day 14: Pre-dose and at multiple time points (up to 24 hours for Cohorts 1, 2, 4, and 5; up to 12 hours for Cohort 3) post-dose|The PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2569675|NCT02539134|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-935||Day 1 and Day 14: Pre-dose and at multiple time points (up to 24 hours for Cohorts 1, 2, 4, and 5; up to 12 hours for Cohort 3) post-dose|The pharmacokinetic (PK) set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2569676|NCT02539134|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose||Baseline up to Day 15|The safety analysis set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
2569677|NCT02539134|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose||Baseline up to Day 15|The safety analysis set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
2569678|NCT02539134|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose||Baseline up to Day 15|The safety analysis set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
2569679|NCT02539134|Primary|Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)||Day 1 up to Day 28|The safety analysis set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
2569680|NCT02539108|Secondary|Geometric Mean Titer Ratios of Influenza Virus Antibodies Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Geometric mean of titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer ratios|Day 0 (pre-vaccination) and 28 days post-last vaccination|Anti-influenza antibody titers were assessed in the Per-protocol Analysis Set.|||Titer ratio||95% Confidence Interval|Geometric Mean
2569681|NCT02539108|Secondary|Number of Participants Who Achieved Seroconversion Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-final vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-final vaccination titer.|28 days post-last vaccination|Anti-influenza antibody titers were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2569682|NCT02539108|Secondary|Number of Participants Who Achieved Seroprotection to Influenza Virus Antigens Pre- and Post-Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay. Seroprotection was defined as a pre-vaccination or post-vaccination influenza antibody titer of ≥ 1:40 (1/dilutions).|Day 0 (pre-vaccination) and 28 days post-last vaccination|Anti-influenza antibody titers were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2569683|NCT02539108|Secondary|Geometric Mean Titers of Influenza Virus Antibodies Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Anti-influenza antibodies were measured using an hemagglutination inhibition assay.|Day 0 (pre-vaccination) and 28 days post-last vaccination|Anti-influenza antibody titers were assessed in the Per-protocol Analysis Set.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
2569693|NCT02538965|Secondary|Percentage of Participants With of Graft Versus Host Disease (GVHD)|Acute graft versus host disease generally occurs after allogeneic hematopoietic stem cell transplantation. It is a reaction of donor immune cells against host tissues. The 3 main tissues that acute GVHD affects are the skin, liver, and gastrointestinal tract. Chronic GVHD is scored per the National Institute of Health consensus conference grading system. Clinical manifestations of chronic GVHD include skin involvement resembling lichen planus or the cutaneous manifestations of scleroderma; dry oral mucosa with ulcerations and sclerosis of the gastrointestinal tract; and a rising serum bilirubin concentration.|From the first dose of study drug to 28 days after the last dose of study drug; up to data cut off date of 31 December 2017; maximum treatment was 12 weeks|The Safety population consisted of all participants who received at least 1 dose of lenalidomide.|||Percentage of Participants|||Number
2569684|NCT02539108|Primary|Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2015-2016 Formulation of Fluzone® Quadrivalent Influenza Vaccine.|"Solicited injection-site reactions for 6 to < 36 months: Tenderness, Erythema, and Swelling. For 3 to < 9 years: Pain, Erythema, and Swelling. Solicited systemic reactions for 6 to < 36 months: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. For 3 to < 9 years: Fever (Temperature), Headache, Malaise, and Myalgia.~Grade 3 for 6 to < 36 months: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Vomiting, 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, sleeping most of the time or difficult to wake up; Appetite lost, Refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, Inconsolable.~Grade 3 for 3 to < 9 years: Pain, Incapacitating; Erythema and Swelling, ≥ 50 mm; Fever, ≥ 39.0°C; Headache, Malaise, and Myalgia, prevents daily activity."|Day 0 up to Day 7 post any vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
2569685|NCT02538965|Secondary|Correlation of Peripheral White Blood Cell Count, Absolute Blast Count and Cytogenetics With Response to Lenalidomide|Correlation of peripheral white blood cell count, absolute blast count and cytogenetics with response to lenalidomide was not performed since only 1 participant met the primary efficacy endpoint of morphological CR/CRi, and due to scarcity of relevant data, it was not practical or meaningful to analyze to perform the analysis on blood counts and response to lenalidomide.|Not Performed|Due to scarcity of relevant data, it was not practical or meaningful to analyze or perform the analysis on blood counts and response to lenalidomide.||||||
2569686|NCT02538965|Secondary|Apparent Volume of Distribution (Vz/F) of Lenalidomide|Apparent volume of distribution, calculated as [(CL/F)/λz].|Pharmacokinetic sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.|The pharmacokinetic population included participants who received at least one dose of lenalidomide and had at least one measurable lenalidomide concentration.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2569687|NCT02538965|Secondary|Apparent Total Clearance (CL/F) of Lenalidomide|Apparent volume of distribution, calculated as [(CL/F)/λz].|Pharmacokinetic sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.|The pharmacokinetic population included participants who received at least one dose of lenalidomide and had at least one measurable lenalidomide concentration.|||ml/min||Geometric Coefficient of Variation|Geometric Mean
2569688|NCT02538965|Secondary|Terminal Half-Life (t1/2) of Lenalidomide|Terminal phase half-life in plasma, calculated as [(ln 2)/λz]. Terminal half-life was only calculated when a reliable estimate for λz could be obtained.|Pharmacokinetic sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.|The pharmacokinetic population included participants who received at least one dose of lenalidomide and had at least one measurable lenalidomide concentration.|||hours||Geometric Coefficient of Variation|Geometric Mean
2569689|NCT02538965|Secondary|Time to Reach Maximum Concentration (Tmax) of Lenalidomide|Time to cmax was obtained directly from the observed concentration versus time data.|Pk sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.|The pharmacokinetic population included participants who received at least one dose of lenalidomide and had at least one measurable lenalidomide concentration.|||Hours||Full Range|Median
2569690|NCT02538965|Secondary|Maximum Observed Concentration (Cmax) of Lenalidomide|Maximum observed plasma concentration, obtained directly from the observed concentration versus time data.|PK sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.|The pharmacokinetic population included participants who received at least one dose of lenalidomide and had at least one measurable lenalidomide concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2569691|NCT02538965|Secondary|Area Under the Plasma Concentration Time Curve From 0 Extrapolated to Infinity (AUC-inf, AUC0∞) Of Lenalidomide|Area under the plasma concentration-time curve from time 0 extrapolated to infinity, calculated as [AUCt + Ct/ λz]. Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz.|Pharmacokinetic sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.|The pharmacokinetic population included participants who received at least one dose of lenalidomide and had at least one measurable lenalidomide concentration.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2569692|NCT02538965|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of Lenalidomide (AUC-t)|Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration, calculated by linear trapezoidal method when concentrations were increasing and the logarithmic trapezoidal method when concentrations were decreasing.|Pharmacokinetic (PK) sampling was conducted after lenalidomide administration at Cycle 1 and was weight dependent at these timepoints: 0.5, 1, 2, 4, 6, 8 and 24 hours. The 24 hour PK sample was taken prior to the lenalidomide dose on Day 2.|The pharmacokinetic population included participants who received at least one dose of lenalidomide and had at least one measurable lenalidomide concentration.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2569715|NCT02538471|Primary|Number of Participants With Adverse Events|Patients who have received at least one 14 days cycle of the study drug will be followed for toxicity (lack of grade 4 toxicity- primary safety end point). Physical exam (including labs) will be performed every 2 weeks while on the study. Patients will be followed with follow-up visits monthly for the first three months after completing therapy then annually for 5 years. Adverse Events will be monitored throughout the course of the study using the NCI CTCAE vers. 4.0.|until end of study||||Participants|||Count of Participants
2569716|NCT02538419|Secondary|SEMSA - Self Efficacy|Self Efficacy Measure for Sleep Apnea - Self Efficacy The SEMSA contains three sub-scales, each scored on a scale of 1 to 4. A higher score indicates a higher degree of self efficacy associated with treatment of sleep apnea.|6 weeks||||units on a scale||Standard Deviation|Mean
2569694|NCT02538965|Secondary|Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE)|A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of lenalidomide and within 28 days after the last dose. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.3 and based on the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.|From the first dose of study drug until 28 days after the last dose of study drug; up to data cut off date of 31 December 2017; maximum duration of treatment was 12 weeks|The safety population consisted of all participants who received at least one dose of lenalidomide.|||Participants|||Count of Participants
2569695|NCT02538965|Secondary|Number of Participants Who Received a Haematopoietic Stem Cell Transplant (HSCT)|The number of participants who had undergone a haematopoietic stem cell transplant was calculated over the total number of participants in the ITT population. Percentages were also calculated based on whether the transplantation was the first, second, or subsequent transplant post IP administration.|From first dose of study drug up to 5 years post HSCT|The intent to treat population consisted of all enrolled participants regardless of whether they received lenalidomide.|||Participants|||Count of Participants
2569696|NCT02538965|Secondary|Number of Participants With a Morphologic CR, CRi, PR or Treatment Failure at Cycles 1, 2 and 3|"Disease assessment outcome at the end of Cycles 1-3 based on Cheson criteria:~Morphologic CR =~ANC ≥ 1000/μL and platelet ≥ 100,000 without transfusions and/or exogenous growth factor support (no transfusion or exogenous growth factor within 7 days of assessment)~BM < 5% blasts evidence of trilineage hematopoiesis~No evidence of extramedullary disease Morphologic CRi =~1. ANC< 1000/μL and Platelets < 100,000/μL or > 100,000/μL without platelet recovery (requiring transfusion within 7 days of assessment) 2. BM with < 5% blasts and evidence of trilineage hematopoiesis 3. No evidence of extramedullary disease PR =~ANC ≥ 1000/μL and platelets ≥ 100,000 without transfusions and/or exogenous growth factor support~BM with < 5%-25% blasts and at least a 50% decrease in BM blast percent from baseline~No evidence of extramedullary disease Treatment Failure = resistant disease; survival ≥ 7 days post-therapy; failed to achieve CR, CRi, or PR but stable with persistent AML"|Response was assessed at the completion of the 21-day treatment period of cycles 1, 2, 3.|The intent to treat population consisted of all enrolled participants regardless of whether they received lenalidomide. Data are reported for participants who began each treatment cycle.|||Participants|||Count of Participants
2569697|NCT02538965|Secondary|Number of Participants Who Achieved a Best Response of Morphologic Complete Remission, Morphologic Complete Remission Incomplete or Partial Remission|"Overall response rate was defined as the number of participants with best response of CR, CRi or PR.~A CR was defined as:~ANC ≥ 1000/μL and platelets ≥ 100,000 without transfusions and/or exogenous growth factor support (no transfusion or exogenous growth factor within 7 days of assessment);~BM < 5% blasts evidence of trilineage hematopoiesis;~No evidence of extramedullary disease.~A CRi was defined as:~ANC < 1000/μL and platelets < 100,000/μL or > 100,000/μL without platelet recovery (requiring transfusion within 7 days of assessment);~BM with < 5% blasts and evidence of trilineage hematopoiesis;~No evidence of extramedullary disease.~A PR was defined as:~ANC of ≥ 1000/μL and platelets ≥ 100,000 without transfusions and/or exogenous growth factor support (no transfusion or exogenous growth factor within 7 days of assessment);~BM with 5% to 25% blasts and at least a 50% decrease in BM blast percent from baseline;~No evidence of extramedullary disease."|Response was assessed at the completion of the 21-day treatment period of cycles 1, 2, 3.|Intent to Treat Population consisted of all enrolled participants regardless of whether they received lenalidomide.|||Participants|||Count of Participants
2569698|NCT02538965|Secondary|Duration of Response|Duration of response was defined as the time from date of the first observed response (CR, CRi or PR) until morphologic relapse, molecular/cytogenetic relapse, or death only for participants who achieved a response. Due to scarcity of relevant data, it was not practical or meaningful to analyze the duration of response. Only 1 participant had a response and the participant was censored soon after, as the consent was withdrawn; unable to calculate duration of response.|From date of first time of complete response observed until treatment failure or worse; up to data cut-off date of 31 December 2017|ITT population participants that achieved at least a CR or CRi.||||||
2569699|NCT02538965|Secondary|Number of Participants Who Achieved a Bone Marrow Confirmed CR/CRi Lasting 3 Months (Durable Response Rate)|Durable response rate was defined as the percentage of participants who achieved a BM confirmed CR/CRi according to the Modified IWG Response Assessment Lasting 3 Months (from the time to complete response observed until treatment failure or worse) or until transplantation if earlier among all participants eligible for durable response rate analysis, provided the CR/CRi was confirmed in a bone marrow sample). Due to scarcity of relevant data, it was not practical or meaningful to analyze the durable response rate. Only 1 participant had a response and the participant was censored soon after, as the consent was withdrawn; unable to calculate duration of response.|From date of confirmed complete response observed until treatment failure or worse; up to data cut-off date of 31 December 2017|Due to scarcity of relevant data, it was not practical or meaningful to analyze the durable response rate. See description.||||||
2569710|NCT02538523|Primary|Percentage of Participants Whose Change in Pain Rating on the Visual Analog Scale (VAS) Met the Individual Subject Success Criteria|The Visual Analog Scale (VAS) assesses level or degree of pain. It is a horizontal line anchored on the left by the label '0: no pain at all' and on the right by the label '100: worst pain imaginable'. The subject marks a location on the 0-100 line that appears to represent any level of pain he or she is experiencing at that time. This marking is measured with a 0 to 100 mm ruler and the number recorded. For the primary study outcome, the percent change in the VAS pain score recorded at baseline and endpoint is calculated for each subject. Individual subject success is a 30% or greater change in VAS pain scores. A negative (-) percent change indicates a decrease in pain level and is positive for individual subject success. A positive (+) percent change indicates an increase in pain level and is negative for individual subject success. Overall study success is defined as a 35% or greater difference between the proportion of individual successes in each treatment group.|Baseline and Two Months Post-Procedure||||Participants|||Count of Participants
2569700|NCT02538965|Primary|Number of Participants Who Achieved a Morphologic Complete Response Within the First Four Cycles of Lenalidomide Treatment According to the Modified International Working Group (IWG) Criteria|"The morphological complete response rate was defined as the total number of participants with morphological CR observed within the first 4 cycles of lenalidomide (regardless of whether the CR/CRi was observed at the end of Cycle 1, 2, 3 or 4) over the total number of participants evaluable for this endpoint. According to Modified IWG criteria, morphologic CR was defined as:~Absolute neutrophil count (ANC) ≥ 1000/μL and platelets ≥ 100,000 without transfusions and/or exogenous growth factor support (i.e., no transfusion or exogenous growth factor within 7 days of assessment;~Bone marrow < 5% blasts evidence of trilineage hematopoiesis;~No evidence of extramedullary disease.~Morphologic CRi was defined as:~ANC < 1000/μL and platelets < 100,000/μL or > 100,000/μL without platelet recovery (requiring transfusion within 7 days of assessment);~BM with < 5% blasts and evidence of trilineage hematopoiesis;~No evidence of extramedullary disease."|From day of the first dose of IP to end of cycle 4; Response was assessed at the completion of the 21-day treatment period of cycles 1, 2, 3, and 4 and at treatment discontinuation.|The Intent to Treat (ITT) population consisted of all enrolled participants regardless of whether they received lenalidomide. Analysis was not completed due to scarcity of relevant data. See description.|||Participants|||Count of Participants
2569701|NCT02538783|Primary|Change in Weight, 6 Months and 12 Months|Among participants who lost 5 kg or more of baseline weight prior to randomization, assess the degree to which weight loss is maintained in the intervention groups relative to usual care during the 6 months following the cessation of the interventions|12 months||||Kilograms||Standard Deviation|Mean
2569702|NCT02538783|Primary|Change in Weight, Baseline and 6 Months|Among participants who lost 5 kg or more of baseline weight prior to randomization, assess the effectiveness of escalating lottery rewards, relative to the control group, on maintenance of weight loss after 6 months of intervention|6 months||||Kilograms||Standard Deviation|Mean
2569703|NCT02538679|Primary|Morphine Requirement|Compare ultrasound-guided block of the transversus abdominis plane (TAP) vs laparoscopic-guided TAP block, versus no TAP block on opioid consumption in the first 24 hours. Patients hospital chart was queried for use of any intravenous opioid in the first 24 hours after surgery including fentanyl or hydromorphone and conversion to morphine per standard opioid dose conversion. Total morphine equivalents then summed for the 24 hour postoperative period and compared between groups.|24 hours||||mg||Standard Deviation|Mean
2569704|NCT02538666|Secondary|PFS in TMB High and Low Subgroups by TMB Cutoff|PFS in TMB by the following cutoff points: ≥10 mutations/mb, < 10 mutations/mb, ≥13 mutations/mb, <13 mutations/mb|Approximately 37 Months|All TMB Evaluable Participants, Global Population|||Months||95% Confidence Interval|Median
2569705|NCT02538666|Secondary|OS in TMB High and Low Subgroups by TMB Cutoff|OS in TMB by the following cutoff points: ≥10 mutations/mb, < 10 mutations/mb, ≥13 mutations/mb, <13 mutations/mb|Approximately 37 Months|All TMB Evaluable Participants, Global Population|||Months||95% Confidence Interval|Median
2569706|NCT02538666|Secondary|Progression Free Survival (PFS)|PFS (primary definition) was defined as the time between the date of randomization and the first date of documented progression as determined by Blind Independent Central Review (BICR) or death due to any cause, whichever occurred first. Participants who died with no reported progression were considered to have progressed on the date of death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on study tumor assessments and did not die (or died after initiation of the subsequent anti- cancer therapy) were censored on their date of randomization. Participants who started any subsequent anti- cancer therapy without a prior reported Progressive Disease (PD) per BICR were censored at the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.|Approximately 37 months after the first subject is randomized||||Months||95% Confidence Interval|Median
2569707|NCT02538666|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug|Approximately 37 months after the first subject is randomized||||Months||95% Confidence Interval|Median
2569708|NCT02538666|Primary|Overall Survival (OS) of Nivo + Ipi vs Placebo|OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug|Approximately 37 months after the first subject is randomized||||Months||95% Confidence Interval|Median
2569709|NCT02538523|Secondary|Change in Total Score on the Oswestry Disability Index (ODI)|The Oswestry Disability Index (ODI) is a 10-item questionnaire to quantify disability for acute or chronic low back pain. Each question is scored on a scale of 0 (least amount of disability) to 5 (most severe disability). The 10 individual scores are summed to get a total score out of 100. A total score of '0' means no disability and a total score of '100' means the maximum disability possible. Therefore, the higher the total score, the worse the disability and the lesser the total score, the lesser the disability. Change in total score on the ODI from baseline to endpoint measurement is calculated for each subject. A negative (-) change indicates a decrease in disability caused by low back pain and is positive for improvement. A positive (+) change indicates an increase in disability due to low back pain and is negative for improvement.|Baseline and Two Months Post-Procedure||||score on a scale||Standard Deviation|Mean
2569711|NCT02538471|Secondary|Number of Participants With Enhanced Tumor Specific Immunity.||2 years|Due to early termination of the study, blood samples at all time points could not be collected. So this outcome measure couldn't be analyzed.||||||
2569712|NCT02538471|Secondary|Number of Participants Who Had a Change in Their T Regulatory Cell Numbers and Function Over the Course of the Study.|To determine if treatment with TGFβ receptor I kinase inhibitor LY2157299 and localized RT alters the numbers and function of T-reg cells in patients with metastatic breast cancer|2 years|Due to early termination of the study, blood samples at all time points could not be collected. So this outcome measure couldn't be analyzed.||||||
2569713|NCT02538471|Secondary|Number of Participants Who Received Radiation to the Tumor Who Had a Response.|to estimate the local response rate of combining TGFΒ receptor I kinase inhibitor LY2157299 and local radiotherapy|25 weeks|Only one patient continued past 25 weeks.|||Participants|||Count of Participants
2569718|NCT02538419|Secondary|SEMSA - Perceived Risk|Self Efficacy Measure for Sleep Apnea - Perceived Risk The SEMSA contains three sub-scales, each scored on a scale of 1 to 4. A higher score indicates a higher degree of perceived risk associated with sleep apnea.|6 weeks||||units on a scale||Standard Deviation|Mean
2569719|NCT02538419|Secondary|FOSQ|Functional Outcomes of Sleep Questionnaire. The FOSQ is a questionnaire which allows the participant to describe their sleep quality, on a scale of 5 to 20. Higher scores indicate better sleep.|6 weeks||||units on a scale||Standard Deviation|Mean
2569720|NCT02538419|Secondary|Percentage of Participants With Adherence >=4 Hours/Night on Average|Objective adherence to CPAP, percentage with adherence >=4 hours/night on average|6 weeks||||percentage of participants|||Number
2569721|NCT02538419|Primary|Adherence|Objective adherence to CPAP, measured in hours per night.|6 weeks||||hours/night||Standard Deviation|Mean
2569722|NCT02538354|Primary|F. Prausnitzii (FISH Analysis).|The faeces is collected at different time points before and after riboflavin supplementation. To investigate the effect of a riboflavin supplement on the number of F. prausnitzii bacteria in the faeces of active and quiescent Crohn's disease patients.|Different time points up to 6 weeks from start study: Day0, Day7, Day28||||Relative FISH counts from total bacteria||Inter-Quartile Range|Median
2569723|NCT02538107|Primary|Average Duration in Months Mircera Was Administered at Current Dose After the Previous Dose Adjustment||Up to 50 months|Efficacy analysis set. Participants with non-missing values were included.|||months||Standard Deviation|Mean
2569724|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15)||From Month 7 to Month 15|Efficacy analysis set. Participants who were evaluable at the specified time frame were included.|||percentage of participants|||Number
2569725|NCT02538107|Secondary|Hemoglobin Level Based on the Glomerular Filtration Rate (GFR)|GFR is described as the flow rate of filtered fluid through the kidney and was determined using the Cockcroft-Gault formula to calculate the creatinine clearance. For males, creatinine clearance [milliliters per minute (mL/min)] = [(140 minus age) multiplied by (*) (body weight in kilogram [kg]) divided by [72 * serum creatinine milligrams per deciliter (mg/dL)]. For females, creatinine clearance (mL/min) = 0.85 * [(140 minus age) * (body weight in kg)] divided by [72 * serum creatinine (mg/dL)]. Participants were classified based on the GFR in to two groups; GFR less than (<) 30 mL/min and in the range of 30-60 mL/min and hemoglobin levels at different visits were presented.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit.|||g/dL||Standard Deviation|Mean
2569726|NCT02538107|Secondary|Hemoglobin Level Based on the Acute Bleeding Episode(s) During the Study|Participants were classified in to two groups based on the presence of acute bleeding episodes during the study; presence or absence of bleeding episodes.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit.|||g/dL||Standard Deviation|Mean
2569727|NCT02538107|Secondary|Hemoglobin Level Based on the Etiology of Chronic Kidney Disease|Participants were classified based on the etiology of chronic kidney disease. The different etiological reasons included diabetic vasculopathy, hypertensive nephrosclerosis, glomerulonephritis, polycystic kidney, chronic pyelonephritis, other reasons and origin unknown. Hemoglobin levels in participants who had etiology of chronic kidney disease as 'glomerulonephritis' or 'other reasons' were presented as these were the majority of the etiological reasons for chronic kidney disease.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. Participants who were evaluable for the specified group were included and n = number of participants who were evaluable at a particular visit.|||g/dL||Standard Deviation|Mean
2569728|NCT02538107|Secondary|Hemoglobin Level Based on the Presence of Inflammatory Diseases|Participants were classified based on the presence of other inflammatory diseases at baseline in to two groups; participants with presence of inflammatory diseases and participants with absence of inflammatory diseases.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. n = number of participants who were evaluable at a particular visit.|||g/dL||Standard Deviation|Mean
2569729|NCT02538107|Secondary|Hemoglobin Level Based on the Type of Kidney Transplantation Performed|Participants were classified based on the type of kidney transplantation they underwent before entering in to the study in to two groups; participants who received living donation and participants who received cadaveric donation.|Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15 and Entire study (Month 1 to Month 15)|Efficacy analysis set. n = number of participants who were evaluable at a particular visit.|||g/dL||Standard Deviation|Mean
2569730|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 10-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12)||From Month 7 to Month 12|Efficacy analysis set. Participants who were evaluable at the specified time frame were included.|||percentage of participants|||Number
2569731|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 15 (Month 15)||From Month 7 to Month 15|Efficacy analysis set. Participants who were evaluable at the specified time frame were included.|||percentage of participants|||Number
2569732|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 12 (Month 12)||From Month 7 to Month 12|Efficacy analysis set. Participants who were evaluable at the specified time frame were included.|||percentage of participants|||Number
2569733|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 11-13 g/dL From Visit 7 (Month 7) to Visit 9 (Month 9)||From Month 7 to Month 9|Efficacy analysis set.|||percentage of participants|||Number
2569860|NCT02535715|Primary|Hepatic Glucose Production (Co-primary Outcome)|Tritiated glucose infusion during procedures (Baseline and every 30 minutes during procedures) Calculated from plasma(mg/kg-minute). Averaged every 30 minutes.|Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month||||mg/kg-minute||Standard Error|Mean
2569734|NCT02538107|Primary|Percentage of Participants With a Hemoglobin Value of 11-12 Grams Per Deciliter (g/dL) From Visit 7 (Month 7) to Visit 9 (Month 9)||From Month 7 to Month 9|Efficacy analysis set (Included participants who reported no pregnancy during the study period and had dosing and hemoglobin data available during 1 of the 3 visits [Visits 7-9]).|||percentage of participants|||Number
2569735|NCT02538094|Secondary|Change in Fatigue as Assessed by Multidimensional Fatigue Symptom Inventory 30-item Short Form (MFSI-SF) Total Scores|Fatigue was measured via changes in self-reported fatigue on the Multidimensional Fatigue Symptom Inventory 30-item short form (MFSI-SF) total score over the course of active and sham tDCS. Change scores range from -84 to + 84. Positive change values reflect increased symptom burden at the end of the intervention relative to baseline. Negative change scores reflect reduced symptom burden at the end of the intervention relative to baseline.|Assessed at beginning and end of a 5-day treatment week||||score on a scale||Standard Deviation|Mean
2569736|NCT02538094|Primary|Change in Cognition as Assessed by Change in Paced Auditory Serial Addition Test Scores|Change in performance on an individual cognitive test measure raw score from the Minimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS) battery tests (i.e. Paced Auditory Serial Addition Test scores). Change scores range from -120 to + 120. Positive change scores reflect improvement at the end of the intervention relative to baseline. Negative change scores reflect decline at the end of the intervention relative to baseline.|Assessed at beginning and end of a 5-day treatment week||||score on a scale||Standard Deviation|Mean
2569737|NCT02538042|Secondary|Change in Post-quit Cue-reactivity|Difference in craving responses. Craving at each time point was measured on a scale from 0 (no craving) to 100 (strong craving). Value reported represents difference in baseline - week 6.|baseline ,week 6|The number of participants analyzed represents those who completed the entire pretreatment phase in each group.|||units on a scale||Standard Deviation|Mean
2569738|NCT02538042|Secondary|Change in Craving Score During MCE Task (MCE Response)|Craving score across MCE sessions. Scores range from 0 (no craving) to 100 (extreme craving)|week 3, week 4, week 5||||score on a scale||Standard Deviation|Mean
2569739|NCT02538042|Secondary|Change in Number of Cigarettes Smoked Per Day (EXT Response)|Reduction in total cigarette use over the treatment period will be calculated for each group. Average cigarettes per day was calculated using the average number for the 5 days leading up to week 3 and the average number for the 5 days leading up to week 6. Values were calculated as number smoked at W3 minus the number smoked at W6. Positive values represent a decrease in smoking behavior.|week 3, week 6|represents all participants who completed both week 3 and week 6 assessments|||mean difference in cigarettes smoked||Standard Deviation|Mean
2569740|NCT02538042|Secondary|Change From Baseline in Number of Usual Brand Cigarettes Smoked (EXT Engagement)|Compliance with smoking VLNCs. Reduction in usual brand (UB) cigarette use over the treatment period will be calculated for each group. Average usual brand cigarettes per day was calculated using the average number for the first 5 days of treatment (week 1) and the average number for the last 5 days of treatment (week 6). Values were calculated as number smoked at W1 minus the number smoked at W6.|week 1, week 6|Number in each group represents the number of participants who completed the pretreatment phase.|||mean difference in UB cigarettes smoked||Standard Deviation|Mean
2569741|NCT02538042|Primary|Number of Participants Who Met Relapse Criteria|Effects of MCE+ (vs. MCE-) on smoking cessation outcomes. Relapse is defined as 7 consecutive days of smoking. Outcome reported as number of participants who met relapse definition.|week 16|All participants randomized to treatment, and completing at least one treatment session|||Participants|||Count of Participants
2569742|NCT02538042|Primary|Change in Fagerstrom Test of Nicotine Dependence Score|Effects of MCE+ (vs. MCE-) on pre-quit nicotine dependence. The score of the questionnaire ranges in value from 0 (not at all dependent) to 10 (highly dependent).|baseline - week 6|Number analyzed represents all participants who completed treatment.|||score on a scale||Standard Deviation|Mean
2569743|NCT02538029|Secondary|Reaction Time|Average time taken to react to a choice of two stimuli. Lower scores indicate better reaction time.|Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks|One participant in Phase 2 was unable to complete the required cognitive assessments, and thus was excluded from all analyses. One participant did not complete this assessment at EOT+4.|||milliseconds||Standard Deviation|Mean
2569744|NCT02538029|Secondary|Trail Making Test|Cognitive task where the participant connects 25 dots in numerical order. Lower scores indicate better cognitive function. Reported here is total time to complete the task.|Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks|One participant in Phase 2 was unable to complete the required cognitive assessments, and thus was excluded from all analyses. One participant did not complete this assessment at EOT+4.|||seconds||Standard Deviation|Mean
2569745|NCT02538029|Secondary|Activities-specific Balance Confidence Scale|Balance questionnaire. Scores range from 0-100, with higher scores indicating greater balance confidence.|Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks|One participant in Phase 2 was unable to complete the required cognitive assessments, and thus was excluded from all analyses.|||units on a scale||Standard Deviation|Mean
2569746|NCT02538029|Secondary|Quality of Life in Neurological Disorders Questionnaire|Quality of life questionnaire. Reported here is T-Score for the Lower Extremity domain. A T-score of 50 is the mean of the reference population, with higher scores indicating a better outcome.|Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks|One participant in Phase 2 was unable to complete the required cognitive assessments, and thus was excluded from all analyses. One participant did not complete this assessment at EOT+4.|||T-score||Standard Deviation|Mean
2569747|NCT02538029|Secondary|2 Minute Walk Test|A functional endurance assessment, reporting total distance traveled over a 2 minute period. Higher values indicate better functional endurance.|Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks|Two participants (one in Phase 1 and one in Phase 2) were unable to complete the required cognitive assessments, and thus were excluded from all analyses.|||meters||Standard Deviation|Mean
2569748|NCT02538029|Primary|Walking Speed During Gait|Average self-selected walking speed without dual tasking.|Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks|Two participants (one in Phase 1 and one in Phase 2) were unable to complete the required cognitive assessments, and thus were excluded from all analyses.|||meters/second||Standard Deviation|Mean
2569749|NCT02538029|Primary|Step Length During Gait|The average distance from heel strike of the less affected leg to heel strike of the more affected leg. Higher values indicate a longer step length.|Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks|Two participants (one in Phase 1 and one in Phase 2) were unable to complete the required cognitive assessments, and thus were excluded from all analyses.|||meters||Standard Deviation|Mean
2569750|NCT02537951|Primary|AFI-intensity After Nociceptive Stimulation|AFI-intensity (delta F/F) at the 3rd fingertip, directly after application of grading nociceptive stimuli|Day 1, T=0h (AFI measurements), Day 1, T=6h (AFI measurements after lidocaine/prilocaine), Day 7 (AFI measurements after capsaicin)||||unitless||Standard Error|Mean
2569751|NCT02537730|Secondary|Stinging and Burning Sensation|Subjective ratings of stinging and burning sensation for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination. Scale 0-10, 0=difficult to wear, 10=no sensation at all.|Baseline||||units on a scale||Standard Deviation|Mean
2569752|NCT02537730|Secondary|Dryness|Subjective ratings of dryness for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent.|1 week||||units on a scale||Standard Deviation|Mean
2569753|NCT02537730|Secondary|Comfort|Subjective ratings of comfort scores for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent.|1 week||||units on a scale||Standard Deviation|Mean
2569754|NCT02537730|Primary|Ocular Health - Corneal Staining|Corneal staining for Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination assessed by slit lamp. Grade 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe.|1 week||||Eyes|Participants||Number
2569755|NCT02537574|Secondary|Area Under the Curve SOWS Score During the Treatment Period Prior to the VIVITROL Injection|The Subjective Opiate Withdrawal Scale (SOWS) is a 16-item self-report questionnaire designed to measure the severity of opioid withdrawal symptoms. The subject rates the intensity of symptoms using a 5-point scale. The range of SOWS scores is 1-10 (mild); 11-20 (moderate); and 21-30 (severe). To determine the daily AUC SOWS score, a curve was generated by plotting the SOWS scores against the time the test was taken. The area under this curve was calculated using the linear trapezoidal rule. For the total AUC SOWS score, the AUCs calculated for each day during the treatment period were added together. To normalize for time, the total AUC SOWS score was then divided by the number of days with daily AUC SOWS score during the treatment period. The AUC SOWS has a different range than the standard scale as it measures not the score itself, but the area under the curve of the score plotted against time.|The SOWS was administered 4-6 times per day during the Treatment Period|All randomized subjects who received at least 1 dose of study drug and had at least 1 post-baseline SOWS measurement.|||Score on a scale||Standard Deviation|Mean
2569756|NCT02537574|Secondary|Incidence of Adverse Effects|The number of subjects who experienced treatment-emergent Adverse Events.|Up to 92 days|The Safety Analysis Set was used to analyze this measure.|||Participants|||Count of Participants
2569757|NCT02537574|Secondary|Mean Score for Desire of Opioids During Treatment Period Prior to VIVITROL Injection|"The Desire for Opioids Visual Analog Scale (VAS) uses a 100-mm, horizontal linear scale, with 0 anchored on the left representing no desire for opioids and 100 anchored on the right representing strongest imaginable desire for opioids. Subjects placed a vertical line on the scale to indicate their desire for opioids at that particular time."|1 week|All randomized subjects who received at least 1 dose of study drug and provided at least 1 post-baseline measureable VAS assessment.|||score on a scale||Standard Deviation|Mean
2569758|NCT02537574|Secondary|Area Under the Curve (AUC) COWS Score During the Treatment Period Prior to VIVITROL Injection|The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal. To determine the daily AUC COWS score, a curve was generated by plotting the COWS scores against the time the test was taken. The area under this curve was calculated using the linear trapezoidal rule. For the total AUC COWS score, the AUCs calculated for each day during the treatment period were added together. To normalize for time, the total AUC COWS score was then divided by the number of days with daily AUC COWS score during the treatment period. The AUC COWS has a different range than the standard scale as it measures not the score itself, but the area under the curve of the score plotted against time.|The COWS was administered 4-6 times per day during the Treatment Period (Days 1-7)|All randomized subjects who received at least 1 dose of study drug and had 1 post-baseline COWS measurement.|||Score on a scale||Standard Deviation|Mean
2569759|NCT02537574|Secondary|Mean Peak COWS Score During Treatment Period Prior to VIVITROL Injection|The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal.|1 week|The Full Analysis Set (FAS) included all subjects in the Safety Population (randomized subjects who received at least 1 dose of study drug), excluding the second enrollment of duplicate subjects (those subjects who enrolled multiple times in the same study).|||score on a scale||Standard Deviation|Mean
2569760|NCT02537574|Secondary|Proportion of Days With COWS Peak Score of Less Than or Equal to 12 During the Treatment Period Prior to the VIVITROL Injection|The Clinical Opiate Withdrawal Scale (COWS) is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal.|1 week|The Full Analysis Set (FAS) included all subjects in the Safety Population (randomized subjects who received at least 1 dose of study drug), excluding the second enrollment of duplicate subjects (those subjects who enrolled multiple times in the same study).|||Number of days||Standard Deviation|Mean
2569761|NCT02537574|Primary|Proportion of Subjects Who Receive and Tolerate a VIVITROL Injection|Toleration to the injection was demonstrated by mild opioid withdrawal symptoms (Clinical Opiate Withdrawal Scale [COWS] </=12 or Subjective Opiate Withdrawal Scale [SOWS] </=10) following VIVITROL administration. The COWS is a clinician-rated questionnaire designed to measure 11 common opioid withdrawal signs or symptoms. The summed score provides information about the level of physical dependence on opioids. The range of COWS scores is 0-4 (none to minimal); 5-12 (mild); 13-24 (moderate); 25-36 (moderately severe); and 37-48 (severe withdrawal. The SOWS is a 16-item self-report questionnaire designed to measure the severity of opioid withdrawal symptoms. The subject rates the intensity of symptoms using a 5-point scale. The range of SOWS scores is 1-10 (mild); 11-20 (moderate); and 21-30 (severe).|1 week|The Full Analysis Set (FAS) includes all subjects in the Safety Population (randomized subjects who received at least 1 dose of study drug), excluding the second enrollment of duplicate subjects (those subjects who enrolled multiple times in the same study).|||Participants|||Count of Participants
2569762|NCT02537522|Primary|Correlation Between Subjective CLUE Comfort and Corneal Diameter|Assessment The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ Et al. August 2016). Corneal diameter (horizontal visible iris diameter [HVID]) was collected at baseline for both eyes using a slit lamp reticle, measuring to the nearest 0.05 mm.The maximum (or minimum) measurements of HVID between the two eyes of each subject were used for correlation analyses between subjective CLUE comfort score and corneal diameter.|3-day follow-up|Subjects that completed all study visits without a major protocol deviation.|||Pearson Correlation|||Number
2569763|NCT02537522|Primary|Correlation Between Subjective CLUE Comfort and Keratometry|CLUE- The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ. Et al. August 2016). Keratometry measurements of major keratometric meridians (diopter [DK]) and their location (degrees) was collected at baseline for both eyes. The correlation between CLUE comfort and maximum Keratometry measurements of the two eyes within each subject and the correlation between CLUE comfort and the minimum Keratometry measurements of the two eyes within each subject were reported.|3-day follow-up|Subjects that completed all study visits without a major protocol deviation.|||Pearson Correlation|||Number
2569764|NCT02537444|Primary|Number of Participants With Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Every 12 weeks for up to 2 years.||||Participants|||Count of Participants
2569765|NCT02537431|Secondary|Percent Change From Baseline Over Time in BALP|BALP: bone-specific alkaline phosphatase.|Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, EOSII (up to Week 141)|Full Analysis Set: all enrolled participants who receive at least one dose of study drug with non-missing results at given time point.|||percent change in BALP||Standard Error|Least Squares Mean
2569766|NCT02537431|Secondary|Change From Baseline Over Time in BALP|BALP: bone-specific alkaline phosphatase.|Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, EOSII (up to Week 141)|Full Analysis Set: all enrolled participants who receive at least one dose of study drug with non-missing results at given time point.|||μg/L||Standard Error|Least Squares Mean
2569767|NCT02537431|Secondary|Percent Change From Baseline Over Time in CTx|CTx: carboxy-terminal cross-linked telopeptide of type I collagen.|Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, EOSII (up to Week 141)|Full Analysis Set: all enrolled participants who receive at least one dose of study drug with non-missing results at given time point.|||percent change in CTx||Standard Error|Least Squares Mean
2569768|NCT02537431|Secondary|Change From Baseline Over Time in CTx|CTx: carboxy-terminal cross-linked telopeptide of type I collagen.|Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, EOSII (up to Week 141)|Full Analysis Set: all enrolled participants who receive at least one dose of study drug, with non-missing results at given time point.|||pg/mL||Standard Error|Least Squares Mean
2569769|NCT02537431|Secondary|Percent Change From Baseline Over Time in P1NP||Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, EOSII (up to Week 141)|Full Analysis Set: all enrolled participants who receive at least one dose of study drug, with non-missing results at given time point.|||percent change in P1NP||Standard Error|Least Squares Mean
2569770|NCT02537431|Secondary|Change From Baseline Over Time in P1NP|P1NP: procollagen type 1 N-propeptide.|Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, EOSII (up to Week 141)|Full Analysis Set: all enrolled participants who receive at least one dose of study drug, with non-missing results at given time point.|||ng/mL||Standard Error|Least Squares Mean
2569771|NCT02537431|Secondary|Change From Baseline Over Time in TRP|TRP: tubular reabsorption of phosphate.|Baseline, Week 2, Week 4, Week 12, Week 22, Week 24, Week 48, Week 60, Week 72, Week 84, Week 96, EOSII (up to Week 141)|Full Analysis Set: all enrolled participants who receive at least one dose of study drug with non-missing results at given time point.|||fraction of phosphorus reabsorbed||Standard Error|Least Squares Mean
2569772|NCT02537431|Secondary|Change From Baseline Over Time in TmP/GFR|TmP/GFR: ratio of renal tubular maximum reabsorption rate of phosphate to glomerular filtration rate.|Baseline, Week 2, Week 4, Week 12, Week 22, Week 24, Week 48, Week 60, Week 72, Week 84, Week 96, EOSII (up to Week 141)|Full Analysis Set: all enrolled participants who receive at least one dose of study drug, with non-missing results at given time point.|||mg/dL||Standard Error|Least Squares Mean
2569773|NCT02537431|Secondary|Change From Baseline Over Time in 24-Hour Urinary Phosphorus||Baseline, Week 12, Week 24, Week 36, Week 48, Week 72, Week 96, End of Study II (EOSII) (up to Week 141)|Full Analysis Set: all enrolled participants who receive at least one dose of study drug with non-missing results at given time point.|||g/24 hours||Standard Error|Least Squares Mean
2569774|NCT02537431|Secondary|Change From Baseline Over Time in Serum 1,25(OH)2D||Baseline, Week 1, Week 2, Week 4, Week 20, Week 21, Week 22, Week 24, Week 48, Week 60, Week 70, Week 72, Week 84, Week 94, Week 96, Week 108, Week 120, Week 132|Full Analysis Set: all enrolled participants who receive at least one dose of study drug with non-missing results at given time point.|||pg/mL||Standard Error|Least Squares Mean
2569775|NCT02537431|Secondary|Time-Adjusted Area Under the Curve (AUC) of Serum Phosphorus Between Baseline and Week 24||Baseline, up to 24 weeks|Full Analysis Set: all enrolled participants who receive at least one dose of study drug.|||mg/dL||Standard Deviation|Mean
2569776|NCT02537431|Secondary|Percentage Change of Serum Phosphorus Levels at the End of Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24||Baseline, up to 24 weeks|Full Analysis Set: all enrolled participants who receive at least one dose of study drug.|||percent change of serum phosphorus level||Standard Deviation|Mean
2569777|NCT02537431|Secondary|Mean Change of Serum Phosphorus Levels at the End of Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24||Baseline, up to 24 weeks|Full Analysis Set: all enrolled participants who receive at least one dose of study drug.|||mg/dL||Standard Deviation|Mean
2569778|NCT02537431|Secondary|Percent Change of Serum Phosphorus Levels at the Mid-Point of Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24||Baseline, up to 24 weeks|Full Analysis Set: all enrolled participants who receive at least one dose of study drug.|||percent change of serum phosphorus level||Standard Deviation|Mean
2569779|NCT02537431|Secondary|Mean Change of Serum Phosphorus Levels at the Mid-Point of Dosing Cycle, as Averaged Across Dose Cycles Between Baseline and Week 24||Baseline, up to 24 weeks|Full Analysis Set: all enrolled participants who receive at least one dose of study drug.|||mg/dL||Standard Deviation|Mean
2569780|NCT02537431|Secondary|Percentage of Participants Achieving Mean Serum Phosphorus Levels Above the LLN at the End of the Dosing Cycle Between Baseline and Week 24|The LLN was defined as 2.5 mg/dL (0.81 mmol/L). The 95% CI was calculated using Wilson score method.|Baseline, up to 24 weeks|Full Analysis Set: all enrolled participants who receive at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2569781|NCT02537431|Secondary|Change From Baseline in BFR/BV at Week 48|BFR/BV: equivalent to bone turnover rate.|Baseline, 48 weeks|Primary Analysis Set: enrolled participants with baseline and follow-up (Week 48/end of treatment) bone biopsy data; participants with non-missing results.|||percentage of bone turnover/year||Standard Deviation|Mean
2569782|NCT02537431|Secondary|Change From Baseline in BFR/OS at Week 48|BFR/OS: bone formation rate to osteoid surface ratio, related to the Aj.AR (amount of new bone created [bone formation rate over the entire osteoid surface]).|Baseline, 48 weeks|Primary Analysis Set: enrolled participants with baseline and follow-up (Week 48/end of treatment) bone biopsy data; participants with non-missing results.|||µm^3/µm^2/year||Standard Deviation|Mean
2569783|NCT02537431|Secondary|Change From Baseline in BFR/BS at Week 48|"BFR/BS: amount of new bone formed in unit time per unit of bone surface; calculated by multiplying MS/BS by the MAR.~MS/BS: percent of bone surface that displays a tetracycline label reflecting active mineralization; calculated as the double-labeled surface plus one half of the single-labeled surface and is expressed as a function of total bone surface ([dLS + sLS/2]/BS). It is a measure of the proportion of bone surface upon which new mineralized bone was being deposited during the period of tetracycline labeling. MAR: linear rate of new bone deposition; mean distance between the double labels, divided by the time interval between them."|Baseline, 48 weeks|Primary Analysis Set: enrolled participants with baseline and follow-up (Week 48/end of treatment) bone biopsy data; participants with non-missing results.|||µm^3/µm^2/year||Standard Deviation|Mean
2569784|NCT02537431|Secondary|Change From Baseline in MS/BS at Week 48|MS/BS: percent of bone surface that displays a tetracycline label reflecting active mineralization; calculated as the double-labeled surface plus one half of the single-labeled surface and is expressed as a function of total bone surface ([dLS + sLS/2]/BS). It is a measure of the proportion of bone surface upon which new mineralized bone was being deposited during the period of tetracycline labeling.|Baseline, 48 weeks|Primary Analysis Set: enrolled participants with baseline and follow-up (Week 48/end of treatment) bone biopsy data who had non-missing data.|||percent of mineralizing surface||Standard Deviation|Mean
2569785|NCT02537431|Secondary|Change From Baseline in MAR at Week 48|MAR: linear rate of new bone deposition; mean distance between the double labels, divided by the time interval between them.|Baseline, 48 weeks|Primary Analysis Set: enrolled participants with baseline and follow-up (Week 48/end of treatment) bone biopsy data who had non-missing results.|||µm/day||Standard Deviation|Mean
2569786|NCT02537431|Secondary|Percent Change From Baseline in MLt at Week 48|MLt: average time interval between osteoid formation and its subsequent mineralization; calculated by dividing the osteoid thickness by the adjusted apposition rate (O.Th/Aj.AR). Aj.AR; amount of new bone created (bone formation rate over the entire osteoid surface). Based on imputed MLt values.|Baseline, 48 weeks|Primary Analysis Set: enrolled participants with baseline and follow-up (Week 48/end of treatment) bone biopsy data who had non-missing results.|||percent change in average time interval||Standard Deviation|Mean
2569787|NCT02537431|Secondary|Percent Change From Baseline in OS/BS at Week 48|OS/Bs: percent of bone surface covered in osteoid.|Baseline, 48 weeks|Primary Analysis Set: enrolled participants with baseline and follow-up (Week 48/end of treatment) bone biopsy data; participants with non-missing results.|||percent change of bone surface covered||Standard Deviation|Mean
2569788|NCT02537431|Secondary|Percent Change From Baseline in O.Th at Week 48|O.Th: mean thickness, given in micrometers, for osteoid seams.|Baseline, 48 weeks|Primary Analysis Set: enrolled participants with baseline and follow-up (Week 48/end of treatment) bone biopsy data; participants with non-missing results.|||percentage change in thickness||Standard Deviation|Mean
2569789|NCT02537431|Secondary|Percentage of Participants Achieving Mean Serum Phosphorus Levels Above the Lower Limit of Normal (LLN) at the Mid-Point of the Dose Interval, as Averaged Across Dose Cycles Between Baseline and Week 24|The LLN was defined as 2.5 mg/dL (0.81 mmol/L). The 95% confidence interval (CI) was calculated using Wilson score method.|Baseline, up to 24 weeks|Full Analysis Set: all enrolled participants who receive at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2571622|NCT02513732|Secondary|Minimum Blood Vessel Diameter|Minimum blood vessel diameter measured by QCA|During follow-up, at 8 months post procedure|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mm|Number of lesions QCA|Standard Deviation|Mean
2569790|NCT02537431|Primary|Percent Change From Baseline in OV/BV at Week 48|OV/BV: percent of a given volume of bone tissue that consists of unmineralized bone (osteoid).|Baseline, 48 weeks|Primary Analysis Set: enrolled participants with baseline and follow-up (Week 48/end of treatment) bone biopsy data; participants with non-missing results.|||percentage change of unmineralized bone||Standard Deviation|Mean
2569791|NCT02537015|Other Pre-specified|Change From Baseline in Endothelial Cell Count|Density (number of cells/mm^2) of corneal endothelial cells was determined at four sites using specular microscopy of the central corneal endothelium at Baseline and at Week 38.|Baseline (Day 0, enrollment in this study) to end of study (Week 38)|||||||
2569792|NCT02537015|Other Pre-specified|Percentage of Participants Who Received Rescue Treatment|Rescue treatment with topical bimatoprost was available for each eye if deemed necessary by the investigator to achieve desired IOP.|Baseline (Day 0, enrollment in this study) to the end of study (Week 38)|||||||
2569793|NCT02537015|Other Pre-specified|Bimatoprost Ocular Insert Retention Duration|Insert duration was defined as the total duration (in days) that any ocular insert remained in place for each subject, measured from the date of Insert removal minus date of Insert placement + 1.|Baseline (Day 0, enrollment in this study) to the end of study (Week 38)|||||||
2569794|NCT02537015|Other Pre-specified|Percentage of Participants by Subject-Reported Comfort Assessment Categories|The participant assessed their overall comfort with ocular inserts using the following rating choices: Not aware of inserts, very comfortable; Aware of inserts, and comfortable; Tolerable, but mild discomfort; Moderate discomfort or Severe discomfort. The percentage of participants in each rating category is reported.|Baseline (Day 0, enrollment in this study) Weeks 4, 8, 12, 24 and 38|||||||
2569795|NCT02537015|Other Pre-specified|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. IOP measurements were taken at 8 am (Time (T)=0 hour) at Weeks 4, 8, 12, 24 and 38. Diurnal IOP measurements were also taken at 10 am (T=2 hour), and 4 pm (T=8 hour) at Weeks 12, 24 and 38. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated an improvement. Baseline is defined as the IOP assessment done at the Randomization visit (Day 0) of study FSV5-004.|Baseline (Day 0 in study FSV5-004) to Weeks 4, 8, 12, 24 and 38|||||||
2569796|NCT02537015|Primary|Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity|An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.|Baseline (Day 0, enrollment in this study) to end of study (Week 38)|Safety Population included all enrolled participants who had at least one 13 mg Bimatoprost Ocular Insert placed.|||percentage of participants|||Number
2569797|NCT02536976|Secondary|Change in Unified Parkinson's Disease Rating Scale|The UPDRS assesses motor and functional abilities of the subjects as it pertains to Parkinson's disease. The total UPDRS score (range 0-199; defined for this study as the sum of Parts I, II, III, and IV (I-Mentation, behavior, and mood section (4 items; range 0-16); II-Activities of Daily Living (ADL; 13 items; range 0-52); III-motor section (27 items; range 0-108) and IV-complications section; 11 items; range 0-23) will be completed by history and examination. Higher scores indicate greater severity of Parkinson's disease symptoms.|From Week 2 to Week 14||||units on a scale||Full Range|Mean
2569798|NCT02536976|Secondary|Change in Overactive Bladder Questionnaire Subscale Scores|The Overactive Bladder Questionnaire (OABQ) is a 33-item, self-administered instrument that contains a symptom bother scale (8 items) and a health-related quality of life (HRQL) scale (25 items), pertaining to OAB symptoms impact on HRQL. Symptom bother score ranges from 0-100 with higher scores indicating greater severity of symptoms. The HRQL score ranges from 0-100 with higher scores indicating better quality of life.|From Week 2 to Week 14||||units on a scale||Full Range|Mean
2569799|NCT02536976|Primary|Change in Montreal Cognitive Assessment Total Score|Change in Montreal Cognitive Assessment Total Score between week 2 and week 14. The Montreal Cognitive Assessment is a screening tool for global cognitive function with a total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function. Normal range is 26 thru 30.|From Week 2 to Week 14||||units on a scale||Full Range|Mean
2569800|NCT02536781|Secondary|VAS Scores Range From 0 (no Pain) to 10 (Severe Pain)||Days 0 and 7 after treatment||||units on a scale||Standard Deviation|Mean
2569801|NCT02536781|Primary|Wound Size (mm^2) Reduction|Comparing between the active and placebo about the wound size reduction from day 0 to day 7 after treatment|Days 0 and 7 after treatment||||mm^2||Standard Deviation|Mean
2569802|NCT02536664|Secondary|Percentage of Participants With Initiation of New Therapy|Percentage of participants for whom new therapy was initiated at the end of maintenance therapy was reported.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.|||percentage of participants|||Number
2569803|NCT02536664|Secondary|Percentage of Participants With Best Overall Response|The percentage of participants was presented with respect to the best overall response (CR, PR, SD). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.|||percentage of participants||95% Confidence Interval|Number
2569813|NCT02536339|Secondary|Maximum Serum Concentrations (Cmax) of Pertuzumab at Specified Timepoints||Post-infusion (0-30 minutes, infused over 60 minutes) on Day 1 of Week 1 and 16|Pharmacokinetics (PK)-Evaluable Population: all participants in the ITT population who received any dose of study treatment and had at least one PK assessment unless there were major protocol deviations or if information impacting PK evaluation (e.g., exact blood sampling time, labeling error, technical failure in sample analysis) were unavailable.|||micrograms per millilitre (ug/mL)||Standard Deviation|Mean
2569804|NCT02536664|Secondary|Percentage of Participants With Response (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD] at the End of Maintenance Therapy|CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR is defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.|||percentage of participants|||Number
2569805|NCT02536664|Secondary|Median Overall Survival (OS) Time|Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive. OS was assessed using Kaplan-Meier estimate.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.|||months||95% Confidence Interval|Median
2569806|NCT02536664|Secondary|Percentage of Participants Who Were Alive|Death for any reason was regarded as an event. Percentage of participants who were alive after 2 years of maintenance therapy with Rituximab was reported.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.|||percentage of participants||95% Confidence Interval|Number
2569807|NCT02536664|Secondary|Median Progression Free Survival (PFS) Time|PFS was defined as the time from the date of the first cycle to the first occurrence of progression of tumor or death from any reason (whichever occurred first). If progression or death was not observed during the study, progression-free survival time was censored by the last documented tumor assessment during the maintenance therapy (latest at the end of study after two years). Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier estimate.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.|||months||95% Confidence Interval|Median
2569808|NCT02536664|Primary|Percentage of Participants Who Were Alive and Free From Progressive Disease|Progressive Disease is defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking) as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.|2 years|Included participants who were considered for the efficacy analysis after 2 years of Rituximab maintenance therapy.|||percentage of participants||95% Confidence Interval|Number
2569809|NCT02536339|Secondary|Symptom Interference Scale Score Over Time, Assessed by Participant Reporting on the MDASI-BT Questionnaire|"The MDASI-BT consists of 28 items and is a multi-symptom measure of cancer-related symptoms that are sensitive to disease and treatment changes. The MDASI-BT is composed of the symptom severity scale and the symptom interference scale. In the symptom interference scale, participants rate interference with daily activities caused by their symptoms on 0−10 numeric scales ranging from 0 = did not interfere to 10 = interfered completely. The MDASI-BT symptom interference scale score will be calculated by (sum of total scores of non-missing items) divided by (total number of non-missing items), if participants answered at least 4 of the 6 interference scale items. The score will be considered missing if less than 4 items are completed."|Baseline, Weeks 6, 12, 20, and 28, and then every 12 weeks until progression (up to approximately 5.25 years)||2022-03-31|03/2022||||
2569810|NCT02536339|Secondary|Symptom Severity Scale Score Over Time, Assessed by Participant Reporting on the M.D. Anderson Symptom Inventory-Brain Tumor (MDASI-BT) Questionnaire|"The MDASI-BT consists of 28 items and is a multi-symptom measure of cancer-related symptoms (Cleeland et al. 2000) that are sensitive to disease and treatment changes. The MDASI-BT is composed of the symptom severity scale and the symptom interference scale. In the symptom severity scale, participants rate the severity of their symptoms in the last 24 hours on 0−10 numeric scales, ranging from 0 = not present to 10 = as bad as you can imagine. The MDASI-BT symptom severity scale score will be calculated by (sum of total scores of non-missing items) divided by (total number of non-missing items), if participants answered at least 12 of the 22 severity scale items. The score will be considered missing if less than 12 items are completed."|Baseline, Weeks 6, 12, 20, and 28, and then every 12 weeks until progression (up to approximately 5.25 years)||2022-03-31|03/2022||||
2569811|NCT02536339|Secondary|Maximum Serum Concentrations (Cmax) of Trastuzumab at Specified Timepoints||Post-infusion (0-30 minutes, infused over 60 minutes) on Day 1 of Week 1 and 16|Pharmacokinetics (PK)-Evaluable Population: all participants in the ITT population who received any dose of study treatment and had at least one PK assessment unless there were major protocol deviations or if information impacting PK evaluation (e.g., exact blood sampling time, labeling error, technical failure in sample analysis) were unavailable.|||micrograms per millilitre (ug/mL)||Standard Deviation|Mean
2569812|NCT02536339|Secondary|Observed Trough Serum Concentrations (Cmin) of Trastuzumab at Specified Timepoints|Per protocol eligibility criteria, participants were not required to be trastuzumab naïve; therefore trastuzumab was detectable in some participants pre-dose at Week 1.|Pre-dose (0−4 hours) on Day 1 of Weeks 1, 4, 10, and 16|Pharmacokinetics (PK)-Evaluable Population: all participants in the ITT population who received any dose of study treatment and had at least one PK assessment unless there were major protocol deviations or if information impacting PK evaluation (e.g., exact blood sampling time, labeling error, technical failure in sample analysis) were unavailable.|||micrograms per millilitre (ug/mL)||Standard Deviation|Mean
2569826|NCT02536339|Secondary|Overall Survival|Overall survival was defined as the period from the date of first dose until the date of death from any cause. If no death occurred, overall survival was censored on the last date the participant was known to be alive.|From the date of first dose until death due to any cause (up to approximately 5.25 years)||2022-03-31|03/2022||||
2569814|NCT02536339|Secondary|Observed Trough Serum Concentrations (Cmin) of Pertuzumab at Specified Timepoints|Per protocol eligibility criteria, participants were not required to be pertuzumab naïve; therefore pertuzumab was detectable in some participants pre-dose at Week 1.|Pre-dose (0−4 hours) on Day 1 of Weeks 1, 4, 10, and 16|Pharmacokinetics (PK)-Evaluable Population: all participants in the ITT population who received any dose of study treatment and had at least one PK assessment unless there were major protocol deviations or if information impacting PK evaluation (e.g., exact blood sampling time, labeling error, technical failure in sample analysis) were unavailable.|||micrograms per millilitre (ug/mL)||Standard Deviation|Mean
2569815|NCT02536339|Secondary|Number of Participants With NCI-CTCAE v4.0 Grades 3 and 4 Clinical Laboratory Abnormalities in Blood Chemistry Tests Over Time|Clinical laboratory tests for blood chemistry parameters were performed every 6 weeks and any abnormal values (High or Low) were based on NCI-CTCAE v4.0 grades. Laboratory abnormalities of NCI-CTCAE v4.0 Grades 3 and 4 are presented. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. For the overall category, multiple occurrences of the same laboratory abnormality over time in one participant were only counted once.|Weeks 6, 12, and 18, and Unscheduled Visits; data cutoff at the primary completion date (up to approximately 3.5 years)|Safety Population: all participants who received at least one dose of study treatment. Only participants with evaluable assessments at each visit were included in the analysis.|||Participants|||Count of Participants
2569816|NCT02536339|Secondary|Number of Participants With NCI-CTCAE v4.0 Grades 3 and 4 Clinical Laboratory Abnormalities in Hematology Tests Over Time|Clinical laboratory tests for hematology parameters were performed every 6 weeks and any abnormal values (High or Low) were based on NCI-CTCAE v4.0 grades. Laboratory abnormalities of NCI-CTCAE v4.0 Grades 3 and 4 are presented. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: clinically significant (per investigator); accompanied by clinical symptoms; resulted in a change in study treatment; or required a change in concomitant therapy. For the overall category, multiple occurrences of the same laboratory abnormality over time in one participant were only counted once.|Baseline, Weeks 18, 36, and 60; data cutoff up to the primary completion date (up to approximately 3.5 years)|Safety Population: all participants who received at least one dose of study treatment. Only participants with evaluable assessments at each visit were included in the analysis.|||Participants|||Count of Participants
2569817|NCT02536339|Secondary|Number of Participants by Investigator Interpretation of Left Ventricular Ejection Fraction (LVEF) Assessments Over Time|Left ventricular ejection fraction (LVEF) is the measurement of the percentage of blood that is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction. All participants were required to have had a baseline LVEF of at least (≥)50% to participate in this study. Measurements were done by either echocardiogram (ECHO) or mulitple-gated acquisition (MUGA) scan (with ECHO as the preferred method). Participants were to be reassessed with the same technique used for baseline cardiac evaluation throughout the study. The following are definitions for the three categories of LVEF findings: 'Normal' was defined as LVEF >45% or LVEF 40-45% with less than (<)10% points drop below baseline; 'Abnormal' was defined as LVEF <40% or LVEF ≥10% points drop below baseline, and clinically significant versus non-clinically significant was subject to the investigator's assessment of whether symptoms were present or absent.|Baseline, Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132 (Treatment Period); and every 3 months during Survival Follow-Up; data cutoff at the primary completion date (up to approximately 3.5 years)|Safety Population: all participants who received at least one dose of study treatment. Only participants with evaluable assessments at each visit were included in the analysis.|||Participants|||Count of Participants
2569818|NCT02536339|Secondary|Median Left Ventricular Ejection Fraction (LVEF) Values Over Time|Left ventricular ejection fraction (LVEF) is the measurement of the percentage of blood that is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction. All participants were required to have had a baseline LVEF of at least 50% to participate in this study. Measurements were done by either echocardiogram (ECHO) or mulitple-gated acquisition (MUGA) scan (with ECHO as the preferred method). Participants were to be reassessed with the same technique used for baseline cardiac evaluation throughout the study.|Baseline, Weeks 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, and 132 (Treatment Period); and every 3 months during Survival Follow-Up; data cutoff at the primary completion date (up to approximately 3.5 years)|Safety Population: all participants who received at least one dose of study treatment. Only participants with evaluable assessments at each visit were included in the analysis.|||Percentage Points of LVEF (%)||Full Range|Median
2569819|NCT02536339|Secondary|Percentage of Participants With at Least One TEAE of Special Interest by Highest Grade of Severity, According to NCI-CTCAE v4.0|Protocol-defined TEAEs of special interest, occurring on or after Day 1 of study treatment until 30 days after the last dose of study treatment, included the following: An elevated ALT or AST (>3 times baseline value) in combination with either an elevated total bilirubin (>2 times the upper limit of normal) or clinical jaundice; Suspected transmission of an infectious agent by the study treatment; Congestive heart failure; An asymptomatic decline in LVEF (a value 10 percentage points below baseline or lower, and <45%) that requires treatment or that leads to discontinuation of study treatment. All TEAEs of special interest were graded for severity using the NCI-CTCAE v4.0. Multiple occurrences of TEAEs of special interest were counted only once per participant at the highest (worst) grade.|From the first dose until 30 days after the last dose of study treatment; data cutoff at the primary completion date (up to approximately 3.5 years)|Safety Population: all participants who received at least one dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2569827|NCT02536339|Secondary|Progression-Free Survival (CNS or Systemic), Assessed Using RANO-BM Criteria and RECIST v1.1|Progression-free survival (CNS or systemic) was defined as the time from the date of first dose to CNS or systemic disease progression or death from any cause. If no CNS or systemic disease progression and no death occurred, data was censored on the date of the last CNS or systemic tumor assessment, whichever occurred first. If a post-baseline assessment was not available, data was censored on Day 1.|From the date of first dose to CNS or systemic disease progression or death from any cause, whichever occurred first (up to approximately 5.25 years)||2022-03-31|03/2022||||
2571623|NCT02513732|Secondary|Minimum Blood Vessel Diameter|Minimum blood vessel diameter measured by QCA|Immediately after the procedure|ITT population|||mm|Number of lesions QCA|Standard Deviation|Mean
2569820|NCT02536339|Secondary|Number of Participants With at Least One TEAE Leading to Trastuzumab Dose Modification by Highest Grade of Severity According to NCI-CTCAE v4.0|Treatment-emergent adverse events (TEAEs) were defined as all adverse events occurring on or after Day 1 of study treatment until 30 days after the last dose of study treatment. All TEAEs were graded for severity using the NCI-CTCAE v4.0; any TEAE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to adverse event. Multiple occurrences of TEAEs were counted only once per participant at the highest (worst) grade.|From the first dose until 30 days after the last dose of study treatment; data cutoff at the primary completion date (up to approximately 3.5 years)|Safety Population: all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2569821|NCT02536339|Secondary|Number of Participants With at Least One TEAE Leading to Pertuzumab Infusion Delay, Slow Down, or Interruption, by Highest Grade of Severity According to NCI-CTCAE v4.0|Treatment-emergent adverse events (TEAEs) were defined as all adverse events occurring on or after Day 1 of study treatment until 30 days after the last dose of study treatment. All TEAEs were graded for severity using the NCI-CTCAE v4.0; any TEAE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to adverse event. Multiple occurrences of TEAEs were counted only once per participant at the highest (worst) grade.|From the first dose until 30 days after the last dose of study treatment; data cutoff at the primary completion date (up to approximately 3.5 years)|Safety Population: all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2569822|NCT02536339|Secondary|Number of Participants With at Least One TEAE Leading to Withdrawal of Any Study Drug, Pertuzumab Only, or Both Pertuzumab and Trastuzumab, by Highest Grade of Severity According to NCI-CTCAE v4.0|Treatment-emergent adverse events (TEAEs) were defined as all adverse events occurring on or after Day 1 of study treatment until 30 days after the last dose of study treatment. All TEAEs were graded for severity using the NCI-CTCAE v4.0; any TEAE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to adverse event. Multiple occurrences of TEAEs were counted only once per participant at the highest (worst) grade.|From the first dose until 30 days after the last dose of study treatment; data cutoff at the primary completion date (up to approximately 3.5 years)|Safety Population: all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2569823|NCT02536339|Secondary|Number of Participants With at Least One Treatment-Emergent Serious Adverse Event (SAE) by Highest Grade of Severity, According to NCI-CTCAE v4.0|"Treatment-emergent serious adverse events (SAEs) were defined as all adverse events that met seriousness criteria (as defined in the protocol; same as the ClinicalTrials.gov definition) occurring on or after Day 1 of study treatment until 30 days after the last dose of study treatment. All SAEs were graded for severity using the NCI-CTCAE v4.0; any SAE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe or medically significant, but not immediately life-threatening; Grade 4 = life-threatening consequences or urgent intervention indicated; and Grade 5 = death related to adverse event. The terms severe and serious are not synonymous and are independently assessed for each adverse event. Multiple occurrences of SAEs were counted only once per participant at the highest (worst) grade."|From the first dose until 30 days after the last dose of study treatment; data cutoff at the primary completion date (up to approximately 3.5 years)|Safety Population: all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2569824|NCT02536339|Secondary|Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) by Highest Grade of Severity, According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0)|Treatment-emergent adverse events (TEAEs) were defined as all adverse events occurring on or after Day 1 of study treatment until 30 days after the last dose of study treatment. All TEAEs were graded for severity using the NCI-CTCAE v4.0; any TEAE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to adverse event. Multiple occurrences of TEAEs were counted only once per participant at the highest (worst) grade.|From the first dose until 30 days after the last dose of study treatment; data cutoff at the primary completion date (up to approximately 3.5 years)|Safety Population: all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2569825|NCT02536339|Secondary|Number of Deaths by Time (≤30 or >30 Days) From Last Study Drug Administration and by Primary Cause of Death||From date of first dose until death due to any cause; data cutoff at the primary completion date (up to approximately 3.5 years)|Safety Population: all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2571624|NCT02513732|Secondary|Minimum Blood Vessel Diameter|Minimum blood vessel diameter measured by QCA|Pre-procedure|ITT population|||mm|Number of lesions QCA|Standard Deviation|Mean
2569828|NCT02536339|Secondary|Progression-Free Survival (Systemic), Assessed Using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)|Progression-free survival (systemic) was defined as the time from the date of first dose to systemic disease progression or death from any cause. If no systemic disease progression and no death occurred, progression-free survival (systemic) was censored on the date of the last systemic tumor assessment. If a post-baseline assessment was not available, progression-free survival (CNS) was censored on Day 1.|From the date of first dose to systemic disease progression or death from any cause, whichever occurred first (up to approximately 5.25 years)||2022-03-31|03/2022||||
2569829|NCT02536339|Secondary|Progression-Free Survival (CNS), Assessed Using RANO-BM Criteria|Progression-free survival (CNS) was defined as the time from the date of first dose to disease progression in the CNS or death from any cause. If no progressive disease in the CNS and no death occurred, progression-free survival (CNS) was censored on the date of the last CNS tumor assessment. If a post-baseline assessment was not available, progression-free survival (CNS) was censored on Day 1.|From the date of first dose to disease progression in the CNS or death from any cause, whichever occurred first (up to approximately 5.25 years)||2022-03-31|03/2022||||
2569830|NCT02536339|Secondary|Median Duration of Clinical Benefit (Confirmed CR, PR, or SD ≥6 Months) in the CNS, Assessed Using RANO-BM Criteria|Responses were assessed by the investigator, based on magnetic resonance imaging (MRI) of the brain, physical examinations, routine neurological examinations, and corticosteroid dosing. Clinical benefit in the central nervous system (CNS) was defined here as a complete response (CR), partial response (PR), or stable disease (SD) for at least 6 months, confirmed by repeat assessment according to RANO-BM criteria. Among participants who achieved clinical benefit, duration of clinical benefit in the CNS was defined as the time from documentation of the first CR, PR, or SD ≥6 months to the time of disease progression, relapse, or death from any cause. If a participant did not experience death or disease progression in the CNS before the end of the study, duration of clinical benefit was censored on the last date the participant was known to be progression free. Duration of clinical benefit was estimated by the Kaplan-Meier method.|From documentation of first complete response (CR), partial response (PR), or stable disease (SD) ≥6 months to the date of disease progression, relapse, or death from any cause, whichever occurred first (up to approximately 3.5 years)|Efficacy-Evaluable Population: all participants in ITT population who received any dose of study treatment and had at least one follow-up CNS tumor assessment or died without follow-up tumor assessment within 30 days from the last dose of study treatment. Only those with confirmed CR, PR, or SD ≥6 months in the CNS were included in this analysis.|||Months||Full Range|Median
2569831|NCT02536339|Secondary|Percentage of Participants With Clinical Benefit (Confirmed CR, PR, or SD ≥6 Months) in the CNS, Assessed Using RANO-BM Criteria|Responses were assessed by the investigator, based on magnetic resonance imaging (MRI) of the brain, physical examinations, routine neurological examinations, and corticosteroid dosing. Clinical benefit in the central nervous system (CNS) was defined here as a complete response (CR), partial response (PR), or stable disease (SD) for at least 6 months, confirmed by repeat assessment according to RANO-BM criteria. A CR or PR were defined in the same way as for objective response in the CNS. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter (LD) while on study. The 95% Clopper-Pearson exact confidence intervals were calculated for responses.|From Baseline until disease progression (assessed every 6 weeks for first 2 scans, followed by every 8 weeks for 2 scans, then every 12 weeks until disease progression; up to approximately 3.5 years)|Efficacy-Evaluable Population: all participants in the ITT population who received any dose of study treatment and had at least one follow-up CNS tumor assessment or died without follow-up tumor assessment within 30 days from the last dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2569832|NCT02536339|Secondary|Median Duration of Clinical Benefit (Confirmed CR, PR, or SD ≥4 Months) in the CNS, Assessed Using RANO-BM Criteria|Responses were assessed by the investigator, based on magnetic resonance imaging (MRI) of the brain, physical examinations, routine neurological examinations, and corticosteroid dosing. Clinical benefit in the central nervous system (CNS) was defined here as a complete response (CR), partial response (PR), or stable disease (SD) for at least 4 months, confirmed by repeat assessment according to RANO-BM criteria. Among participants who achieved clinical benefit, duration of clinical benefit in the CNS was defined as the time from documentation of the first CR, PR, or SD ≥4 months to the time of disease progression, relapse, or death from any cause. If a participant did not experience death or disease progression in the CNS before the end of the study, duration of clinical benefit was censored on the last date the participant was known to be progression free. Duration of clinical benefit was estimated by the Kaplan-Meier method.|From documentation of first complete response (CR), partial response (PR), or stable disease (SD) ≥4 months to the date of disease progression, relapse, or death from any cause, whichever occurred first (up to approximately 3.5 years)|Efficacy-Evaluable Population: all participants in ITT population who received any dose of study treatment and had at least one follow-up CNS tumor assessment or died without follow-up tumor assessment within 30 days from the last dose of study treatment. Only those with confirmed CR, PR, or SD ≥4 months in the CNS were included in this analysis.|||Months||Full Range|Median
2569833|NCT02536339|Secondary|Percentage of Participants With Clinical Benefit (Confirmed CR, PR, or Stable Disease [SD] ≥4 Months) in the CNS, Assessed Using RANO-BM Criteria|Responses were assessed by the investigator, based on magnetic resonance imaging (MRI) of the brain, physical examinations, routine neurological examinations, and corticosteroid dosing. Clinical benefit in the central nervous system (CNS) was defined here as a complete response (CR), partial response (PR), or stable disease (SD) for at least 4 months, confirmed by repeat assessment according to RANO-BM criteria. A CR or PR were defined in the same way as for objective response in the CNS. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter (LD) while on study. The 95% Clopper-Pearson exact confidence intervals were calculated for responses.|From Baseline until disease progression (assessed every 6 weeks for first 2 scans, followed by every 8 weeks for 2 scans, then every 12 weeks until disease progression; up to approximately 3.5 years)|Efficacy-Evaluable Population: all participants in the ITT population who received any dose of study treatment and had at least one follow-up CNS tumor assessment or died without follow-up tumor assessment within 30 days from the last dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2569834|NCT02536339|Secondary|Median Duration of Response in the CNS, Assessed Using RANO-BM Criteria|Responses were assessed by the investigator, based on magnetic resonance imaging (MRI) of the brain, physical examinations, routine neurological examinations, and corticosteroid dosing. An objective response in the central nervous system (CNS) was a complete response (CR) or partial response (PR) confirmed by repeat assessment, according to RANO-BM criteria. Among participants who achieved an objective response, duration of response in the CNS was defined as the time from documentation of the first CR or PR to the time of disease progression, relapse, or death from any cause. If a participant did not experience death or disease progression in the CNS before the end of the study, duration of response was censored on the last date the participant was known to be progression free. Duration of response was estimated by the Kaplan-Meier method.|From documentation of first complete response (CR) or partial response (PR) to the time of disease progression, relapse, or death from any cause, whichever occurred first (up to approximately 3.5 years)|Efficacy-Evaluable Population: all participants in the ITT population who received any dose of study treatment and had at least one follow-up CNS tumor assessment or died without follow-up tumor assessment within 30 days from the last dose of study treatment. Only participants who had a confirmed CR or PR in the CNS were included in this analysis.|||Months||Full Range|Median
2569835|NCT02536339|Primary|Percentage of Participants With Objective Response in the CNS, Assessed Using Response Assessment in Neuro-Oncology-Brain Metastases (RANO-BM) Criteria|Responses were assessed by the investigator, based on magnetic resonance imaging (MRI) of the brain, physical examinations, routine neurological examinations, and corticosteroid dosing. An objective response in the central nervous system (CNS) was a complete response (CR) or partial response (PR) confirmed by repeat assessment, according to RANO-BM criteria. A CR was defined as the disappearance of all CNS target lesions sustained for at least 4 weeks; no new lesions; no corticosteroids; and stable or improved clinically; for non-target lesions, a CR was the disappearance of all enhancing CNS non-target lesions and no new CNS lesions. A PR was defined as at least a 30% decrease in the sum longest diameter (LD) of CNS target lesions, taking as reference the baseline sum LD sustained for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; and stable or improved clinically. The 95% Clopper-Pearson exact confidence intervals were calculated for responses.|From Baseline until disease progression (assessed every 6 weeks for first 2 scans, followed by every 8 weeks for 2 scans, then every 12 weeks until disease progression; up to approximately 3.5 years)|Efficacy-Evaluable Population: all participants in the ITT population who received any dose of study treatment and had at least one follow-up CNS tumor assessment or died without follow-up tumor assessment within 30 days from the last dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2569836|NCT02536313|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure is defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2569837|NCT02536313|Secondary|HCV RNA Change From Baseline/Day 1 Through Week 12||Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2569838|NCT02536313|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Weeks 1, 2, 4, 8 and 12|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2569839|NCT02536313|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 are defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2569840|NCT02536313|Primary|Percentage of Participants Who Permanently Discontinued SOF/VEL/VOX Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who took at least 1 dose of study drug|||percentage of participants|||Number
2569841|NCT02536313|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Treatment (SVR12)|SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: all randomized/enrolled participants who took at least 1 dose of study drug.|||percentage of particpants||95% Confidence Interval|Number
2569842|NCT02536105|Primary|Time to Reach Cmax (Tmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products|PK samples will be taken eight times on each classroom day at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose, and Tmax will be measured|0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day|76 participants entered the double-blind randomization phase and each participant provided at least one data point for these analyses.|||Hours||Standard Deviation|Mean
2569843|NCT02536105|Primary|Maximum Drug Concentration Observed (Cmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products|PK samples will be taken eight times on each classroom day at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose, and Cmax will be measured. The objectives of this measure is to estimate PK metrics, including Cmax, appropriate for characterizing rate and extent of absorption in each phase of the drug release and the evaluate the disposition and eliminating processes for each medication studied. The minimum value is pg/mL and there is was no maximum defined prior to the interventions.|0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day|76 participants entered the double-blind randomization phase and each participant provided at least one data point for these analyses.|||pg/mL||Standard Deviation|Mean
2569858|NCT02535715|Secondary|Plasma Glucose Concentrations|Measured at baseline and every 5 minutes during the procedures(mg/dL), Averaged over 30 minute intervals during the procedure|Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month||||mg/dl||Standard Error|Mean
2569859|NCT02535715|Secondary|Plasma Insulin Concentrations|Baseline and every 15 minutes during procedures (microIU/mL).|Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month|Plasma insulin Concentrations were measured during each procedure in a type 1 DM population Analysis from one subject was not included: Results below threshold of assay|||microUnits/mL||Standard Deviation|Mean
2569844|NCT02536105|Primary|Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products|The Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) scale is a validated, 13-item rating of subjective impairment of classroom behaviors (0 = normal/no impairment; 1 = slight impairment; 2 = mild impairment; 3 = moderate impairment; 4 = severe impairment; 5 = very severe impairment; 6 = maximal impairment). The SKAMP consists of four subscales: SKAMP-Attention, SKAMP-Deportment, SKAMP-Quality of Work, and SKAMP-Compliance, in addition to SKAMP-Total (reported here). SKAMP-Total is a sum of the four sub-scales and has a range of 0-78. The higher the score, the higher the impairment. Scores will be obtained during each classroom cycle during each full laboratory classroom day at pre-dose, and at 0.5, 1.5, 2.5, 4, 5, 6, 8, 10, and 12 hours post-dose. The scores will be based on the child's behavior during 20 minutes of each cycle.|0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day|Note that not all participants who entered the study completed all arms. Thus, the number differs between the arms to reflect the number of participants who provided data for that arm. N=67 for all MPH HCl ER tab 1 time points. N=72 for all placebo time points. N=66 for all MPH HCl tab 2 time points. N=68 for all MPH Hcl ER susp timepoints.|||units on a scale||Standard Deviation|Mean
2569845|NCT02536105|Primary|Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products|The Permanent Product Measure of Performance (PERMP) involves objective individualized mathematics tests. Scores will be obtained ten times on each classroom day at pre-dose, and at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose. PERMP Attempted is reported here. Scale ranges 0 math questions answered to 400 math questions answered. The more number of questions answered (better score), the higher the PERMP Attempted score is.|0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day|Note that not all participants who entered the study completed all arms and all time points, hence the discrepancy in number of participants analyzed between arms and different time points.|||score on a scale||Standard Deviation|Mean
2569846|NCT02536040|Primary|Dental Caries Activity|Proportion of treated teeth with active decay that were arrested by the treatment measured using the Nyvad criterion code 6 reflecting hardness of the lesion and color change|14-21 days||||Proportion of arrested caries lesions||Standard Deviation|Mean
2569847|NCT02535806|Secondary|2-year Overall Survival Seen With Using Bortezomib in Combination With the ALL R3 Re-induction Regimen in Pediatric Patients With Relapsed or Refractory ALL or LL.||2 years||||Participants|||Count of Participants
2569848|NCT02535806|Secondary|Post-induction Level of Minimal Residual Disease Seen With Using Bortezomib in Combination With the ALL R3 Re-induction Regimen in Pediatric Patients With Relapsed or Refractory ALL or LL.|Percent of Cells Positive for Minimal residual disease measured by multiparameter flow cytometry|36 days||||Percentage of Cells Positive for MRD||Full Range|Mean
2569849|NCT02535806|Secondary|Remission Rate Seen With Using Bortezomib in Combination With the ALL R3 Re-induction Regimen in Pediatric Patients With Relapsed or Refractory ALL or LL.|Number of patients with bone marrow blast percentage <5% after treatment|36 days||||Participants|||Count of Participants
2569850|NCT02535806|Primary|Number of Subject With Adverse Events|Toxicities were assessed and graded according to CTCAE v 4.0.|36 days||||Participants|||Count of Participants
2569851|NCT02535741|Secondary|Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire|The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes.|Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up|The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.|||units on a scale||Standard Deviation|Mean
2569852|NCT02535741|Secondary|Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire|The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical (PSC) and mental status component (MCS) score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up|The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.|||units on a scale||Standard Deviation|Mean
2569853|NCT02535741|Secondary|Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, Range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up|The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.|||units on a scale||Standard Deviation|Mean
2569854|NCT02535741|Secondary|Investigation of Patient Outcome With Radiographic Analysis|Plain radiographs will be obtained for assessment of fixation of the device.|Pre-operative, 3 months, 1, 2 and 5 years follow-up|Radiographic data were not collected||||||
2569855|NCT02535741|Primary|Mean Triathlon CR Active Range of Motion (ROM)|Comparison of the active ROM values for patients receiving the Triathlon CR Total Knee System with historical active ROM values of the Scorpio CR Total Knee System, a control group by literature review at 2 years post Total Knee Arthroplasty. See Chaudhary R, et al 2008 JBJS included for historical control data.|2 years follow-up|Comparison to data from the literature was not done.|||degree||Standard Deviation|Mean
2569856|NCT02535715|Secondary|Plasma Free Fatty Acid Concentrations|Measured at baseline and every 30 minutes during the procedures (micro mol/L)|Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month|Wako Calorometric|||mmol/L||Standard Error|Mean
2569857|NCT02535715|Secondary|Plasma Glucagon Concentrations|Measured at baseline and every 30 minutes during the procedures (pg/mL)|Participants will be followed during the procedures, until all 3 procedures are completed, an average of 1 month|Glucagon measured by RIA kit, EMD Millipore.|||pg/mL||Standard Error|Mean
2571625|NCT02513732|Secondary|Lesion Length|The lesion length measured by QCA.|Pre-procedure|ITT population|||mm|Number of lesions QCA|Standard Deviation|Mean
2569861|NCT02535416|Secondary|Pharmacokinetics: Half-Life (t1/2) of the Analytes of ARC-520|Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.|Day 1 pre-dose through 48 hours post-dose|All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected|||hour||Standard Deviation|Mean
2569862|NCT02535416|Secondary|Pharmacokinetics: Terminal Elimination Rate Constant (Lambda z) of the Analytes of ARC-520|Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.|Day 1 pre-dose through 48 hours post-dose|All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected|||1/hr||Standard Deviation|Mean
2569863|NCT02535416|Secondary|Pharmacokinetics: Apparent Volume of Distribution (V) of the Analytes of ARC-520|Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.|Day 1 pre-dose through 48 hours post-dose|All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected|||mL/kg||Standard Deviation|Mean
2569864|NCT02535416|Secondary|Pharmacokinetics: Clearance (CL) of the Analytes of ARC-520|Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.|Day 1 pre-dose through 48 hours post-dose|All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected|||mL/hr/kg||Standard Deviation|Mean
2569865|NCT02535416|Secondary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of the Analytes of ARC-520|Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.|Day 1 pre-dose through 48 hours post-dose|All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected|||ng/mL||Standard Deviation|Mean
2569866|NCT02535416|Secondary|Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero Extrapolated to Infinity (AUCinf) of the Analytes of ARC-520|Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.|Day 1 pre-dose through 48 hours post-dose|All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected|||ng.hr/mL||Standard Deviation|Mean
2569867|NCT02535416|Secondary|Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast) of the Analytes of ARC-520|Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting HBV) and MLP.|Day 1 pre-dose through 48 hours post-dose|All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one PK sample collected|||ng.hr/mL||Standard Deviation|Mean
2569868|NCT02535416|Secondary|Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) of the Analytes of ARC-520|Analytes include AD0009 and AD0010 (cholesterol-conjugated siRNA targeting hepatitis B virus [HBV]) and melittin-like peptide (MLP).|Day 1 pre-dose through 48 hours post-dose|All participants with highest achievable infusion rate up to a slow bolus push (Cohort 6) and all participants receiving 4.0, 5.0 and 6.0 mg/kg using an infusion rate of 0.9 mL/min (Cohorts 3, 7 and 8) who had at least one pharmacokinetic (PK) sample collected|||ng.hr/mL||Standard Deviation|Mean
2569869|NCT02535416|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product.|post-dose through the end of study (Day 15 ± 1 day) plus 30 days|Safety Population: all enrolled participants|||participants|||Number
2569870|NCT02535364|Secondary|Percentage of Participants Who Developed Anti-Therapeutic Antibodies Against JCAR015|Percentage of participants who developed anti-therapeutic antibodies against JCAR015|Part B Screening; Day 14 after the first JCAR015 infusion; Pre-Dose Day 1 of the second JCAR015 infusion; Day 14 after the second JCAR015 infusion; and Day 28, Month 3, Month 6, and Month 12 after the last JCAR015 infusion|The analysis population includes all enrolled subjects who underwent leukapheresis and had a sample that was evaluable for the assay.|||percentage of participants|||Number
2569871|NCT02535364|Secondary|AUC for JCAR015 in the Peripheral Blood as Measured by Flow Cytometry|AUC is defined as the area under the concentration-vs-time curve from Day 1 to Day 29 after the first JCAR015 infusion as measured by flow cytometry of the JCAR015 CAR. AUC calculation includes PK results up to the second JCAR015 infusion for subjects who received the second infusion prior to Day 29 after the first JCAR015 infusion.|Pre-dose Day 1 of the first JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion|The analysis population includes all participants who received at least one infusion of JCAR015.|||cells*days/microliter||Full Range|Median
2569872|NCT02535364|Secondary|Area Under the Concentration-vs-Time Curve (AUC) for JCAR015 in the Peripheral Blood as Measured by qPCR|AUC is defined as the area under the concentration-vs-time curve from Day 1 to Day 29 after the first JCAR015 infusion as measured by qPCR of the JCAR015 transgene. AUC calculation includes pharmacokinetic (PK) results up to the second JCAR015 infusion for subjects who received the second infusion prior to Day 29 after the first JCAR015 infusion.|Pre-dose Day 1 of the first JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion|The analysis population includes all participants who received at least one infusion of JCAR015.|||vector copy number*days/microgram||Full Range|Median
2569946|NCT02534350|Primary|Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in Participants in the Full Analysis Set||Up to 7 days|Participants in the Full Analysis Set (participants who received at least 1 full dose of study drug and had an RSV viral load ≥ lower limit of quantification (LLOQ) of the real-time quantitative polymerase chain reaction (RT-qPCR) assay in the Day 1 nasal sample, as determined by RT-qPCR at the central lab) with available data were analyzed .|||log10 copies/mL||Standard Deviation|Mean
2569873|NCT02535364|Secondary|Tmax in the Peripheral Blood as Measured by Flow Cytometry|Tmax is defined as the time after the JCAR015 infusion at which the Cmax as measured by flow cytometry of the JCAR015 CAR is observed. If Cmax occurred after the second infusion, Tmax was calculated from the time of the second infusion.|Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable)|The analysis population includes all participants who received at least one infusion of JCAR015 and whose Cmax was >0.|||days||Full Range|Median
2569874|NCT02535364|Secondary|Time to Maximum Concentration of JCAR015 (Tmax) in the Peripheral Blood as Measured by qPCR|Tmax is defined as the time after the JCAR015 infusion at which the maximum concentration (Cmax) as measured by qPCR is observed. If Cmax occurred after the second infusion, Tmax was calculated from the time of the second infusion.|Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable)|The analysis population includes all participants who received at least one infusion of JCAR015.|||days||Full Range|Median
2569875|NCT02535364|Secondary|Maximum Concentration of JCAR015 (Cmax) in the Peripheral Blood by Flow Cytometry|Cmax is defined as the highest measured concentration of JCAR015 CAR T cells per microliter of peripheral blood as measured by flow cytometry.|Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable)|The analysis population includes all participants who received at least one infusion of JCAR015.|||cells/microliter||Full Range|Median
2569876|NCT02535364|Secondary|Maximum Concentration of JCAR015 (Cmax) in the Peripheral Blood by Quantitative Polymerase Chain Reaction (qPCR)|Cmax is defined as the highest measured number of copies of JCAR015 transgene per microgram of genomic DNA in peripheral blood cells as assessed by qPCR.|Pre-dose Day 1 of each JCAR015 infusion; Day 4, Day 7, Day 14, Day 21, and Day 28 after the first JCAR015 infusion until receipt of the second infusion; and Day 4, Day 7, Day 14, Day 21, and Day 28 after the second JCAR015 infusion (if applicable)|The analysis population includes all participants who received at least one infusion of JCAR015.|||vector copy number/microgram||Full Range|Median
2569877|NCT02535364|Secondary|Percentage of Participants Who Achieved a Morphologic Remission Within 6 Months After the Final JCAR015 Infusion and Then Proceeded to HSCT|Percentage of participants who achieved a morphologic remission within 6 months after the final JCAR015 infusion and then proceeded to HSCT prior to 12 months after the final JCAR015 infusion|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015, and who were evaluable for response.|||percentage of participants||95% Confidence Interval|Number
2569878|NCT02535364|Secondary|Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRC, at Month 6 After the Final JCAR015 Infusion|ORR at Month 6 is defined as the percentage of participants who achieved a CR or CRi at Month 6 after the final JCAR015 infusion without HSCT during the time period between the final JCAR015 infusion and the Month 6 response assessment (refer to Outcome Measure #1 for criteria for CR and CRi).|Day 1 (first JCAR015 infusion) up to 6 months after the last JCAR015 infusion|The analysis population includes all participants who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015.|||percentage of participants|||Number
2569879|NCT02535364|Secondary|Duration of Remission (DOR) as Determined by an IRC|DOR is defined as the interval from the first documentation of CR or CRi to the earlier date of relapse or death due to ALL.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015, and who achieved a CR or CRi after JCAR015 infusion.|||months||95% Confidence Interval|Median
2569880|NCT02535364|Secondary|OS|OS is defined as the interval from the date of the first JCAR015 infusion to the date of death due to any reason.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes all participants who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015.|||months||95% Confidence Interval|Median
2569881|NCT02535364|Secondary|Overall Survival (OS)|OS is defined as the interval from the date of the first JCAR015 infusion to the date of death due to any reason.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes all participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015.|||months||95% Confidence Interval|Median
2569882|NCT02535364|Secondary|EFS|EFS is defined as the time from the date of the first JCAR015 infusion to the earliest of the following events: death from any cause, relapse, or treatment failure (defined as no response and subsequent discontinuation from the study for adverse event, lack of efficacy or progressive disease, or new anticancer therapy). Participants who proceeded to HSCT after JCAR015 infusion were censored at the time of HSCT.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes all participants who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015.|||months||95% Confidence Interval|Median
2569883|NCT02535364|Secondary|Event-Free Survival (EFS)|EFS is defined as the time from the date of the first JCAR015 infusion to the earliest of the following events: death from any cause, relapse, or treatment failure (defined as no response and subsequent discontinuation from the study for adverse event, lack of efficacy or progressive disease, or new anticancer therapy). Participants who proceeded to HSCT after JCAR015 infusion were censored at the time of HSCT.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes all participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015.|||months||95% Confidence Interval|Median
2569884|NCT02535364|Secondary|RFS, as Determined by an IRC|RFS is defined as the interval from the first documentation of CR or CRi (refer to Outcome Measure #1) to the earlier date of relapse or death due to any cause. Participants who proceeded to HSCT after JCAR015 infusion were censored at the time of HSCT.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015, and who achieved a CR or CRi after JCAR015 infusion.|||months||95% Confidence Interval|Median
2569885|NCT02535364|Secondary|Relapse-Free Survival (RFS), as Determined by an IRC|RFS is defined as the interval from the first documentation of CR or CRi (refer to Outcome Measure #1) to the earlier date of relapse or death due to any cause. Participants who proceeded to hematopoietic stem cell transplant (HSCT) after JCAR015 infusion were censored at the time of HSCT.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015, and who achieved a CR or CRi after JCAR015 infusion.|||months||95% Confidence Interval|Median
2569886|NCT02535364|Secondary|Percentage of Participants Who Achieved a MRD-Negative CR or CRi|Percentage of participants who achieved a CR or CRi, as determined by an IRC, with no evidence of MRD in the bone marrow (refer to Outcome Measure #1 for criteria for CR and CRi). MRD-negative is defined as undetectable leukemic cells in the bone marrow as determined by a PCR-based assay.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes all participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015.|||percentage of participants|||Number
2569887|NCT02535364|Secondary|Percentage of Participants Who Achieved a Minimal Residual Disease (MRD)-Negative CR or CRi|Percentage of participants who achieved a CR or CRi, as determined by an IRC, with no evidence of MRD in the bone marrow (refer to Outcome Measure #1 for criteria for CR and CRi). MRD-negative is defined as undetectable leukemic cells in the bone marrow as determined by a polymerase chain reaction (PCR)-based assay.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes all participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015.|||percentage of participants|||Number
2569888|NCT02535364|Secondary|Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRC|BOR is defined as the best disease response recorded from the time of the last JCAR015 infusion until the start of another anticancer therapy (refer to Outcome Measure #1 for criteria for CR and CRi).|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes all participants with morphologic disease at the time of JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one infusion of JCAR015.|||percentage of participants|||Number
2569889|NCT02535364|Secondary|Percentage of Participants Who Achieved a CR or CRi, as Determined by an IRC|Best overall response (BOR) is defined as the best disease response recorded from the time of the last JCAR015 infusion until the start of another anticancer therapy (refer to Outcome Measure #1 for criteria for CR and CRi).|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes all participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one infusion of JCAR015.|||percentage of participants|||Number
2569890|NCT02535364|Secondary|Percentage of Participants With CR or CRi, as Determined by an IRC|ORR is defined as the percentage of participants with CR or CRi based on IRC assessment (refer to criteria in Outcome Measure #1)|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes participants with morphologic disease who received lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine and at least one JCAR015 infusion, and who were evaluable for response (excludes 5 subjects with Grade 5 brain edema who died within 8 days after JCAR015 infusion).|||percentage of participants||95% Confidence Interval|Number
2569891|NCT02535364|Primary|Percentage of Participants With Complete Remission (CR) or Complete Remission With Incomplete Hematopoietic Recovery (CRi), as Determined by an Independent Review Committee (IRC)|Overall remission rate (ORR) is defined as the percentage of participants with CR or CRi based on IRC assessment. For CR, all of the following must be met: (1) in bone marrow, trilineage hematopoiesis and < 5% blasts; (2) in peripheral blood, neutrophils > 1,000/µL, platelets > 100,000/µL, and circulating blasts < 1%; (3) no clinical evidence of extramedullary disease by physical examination and no symptoms suggestive of CNS involvement (if additional assessments such as CSF assessment by lumbar puncture or Ommaya reservoir tap, CNS imaging, or biopsy are performed, results must show no evidence of disease); (4) no platelet and/or neutrophil transfusions ≤ 7 days before the date of peripheral blood sampling, and (5) no clinical evidence of recurrence for 4 weeks. For CRi, all criteria for CR are met except that one or more of the following exists in the peripheral blood: neutrophils ≤ 1,000/µL, platelets ≤ 100,000/µL, or platelet transfusions ≤ 7 days before blood sampling.|Day 1 (first JCAR015 infusion) up to 12 months after the last JCAR015 infusion|The analysis population includes participants with morphological disease at the time of the first JCAR015 infusion who received lymphodepleting chemotherapy with cyclophosphamide alone and at least one JCAR015 infusion, and who were evaluable for response (excludes 2 subjects with Grade 5 brain edema who died within 8 days after JCAR015 infusion).|||percentage of participants||95% Confidence Interval|Number
2569892|NCT02535065|Primary|Number of Patients With Technical Success|Technical success will be measured with none of the following: type I or III endoleaks requiring re-intervention, graft limb occlusion, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm|12 months||||Participants|||Count of Participants
2569893|NCT02535065|Primary|Number of Patients Without Major Adverse Events|Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation|30 days||||Participants|||Count of Participants
2569947|NCT02534324|Secondary|Systolic Blood Pressure at Follow-up|Systolic blood pressure at follow-up measured by physicians that were non-investigators and unaware of the study.|3 to 7 days||||mmHg||Standard Deviation|Mean
2569894|NCT02535026|Primary|Percentage of Participants With Breast Cancer Phenotypes Among Different Hispanic Countries|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype was identified.|||percentage of participants|Number of Tissue samples||Number
2569895|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype was identified.|||percentage of participants|Tissue samples||Number
2569896|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype was identified.|||percentage of participants|Tissue samples||Number
2569897|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype was identified.|||percentage of participants|Tissue samples||Number
2569898|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.|Baseline up to 30 months|Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.|||percentage of participants|Tissue samples||Number
2569899|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype was identified.|||percentage of participants|Tissue samples||Number
2569900|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Participants were categorized in to following age groups: a) <40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype was identified.|||percentage of participants|Tissue samples||Number
2569901|NCT02535026|Primary|Percentage of Participants With HER2 Status (Positive or Negative) Based on Lymphovascular Invasion|Lymphovascular invasion is entering of breast cancer cells in to the lymph or blood/vascular channels.|Baseline up to 30 months|Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.|||percentage of participants|Tissue samples||Number
2569902|NCT02535026|Primary|Percentage of Participants With HER2 Status (Positive or Negative) Based on Nuclear Grades|Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.|Baseline up to 30 months|Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.|||percentage of participants|Tissue samples||Number
2569903|NCT02535026|Primary|Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups|Participants were categorized in to following age groups: a) <40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years.|Baseline up to 30 months|Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.|||percentage of participants|Tissue samples||Number
2569904|NCT02535026|Primary|Percentage of Participants With PR Status (Positive or Negative) Based on Lymphovascular Invasion|Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.|Baseline up to 30 months|Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.|||percentage of participants|Tissue samples||Number
2569905|NCT02535026|Primary|Percentage of Participants With PR Status (Positive or Negative) Based on Nuclear Grades|Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.|Baseline up to 30 months|Included breast cancer tissue samples from all participants who were willing to participate in the study.|||percentage of participants|Tissue samples||Number
2569906|NCT02535026|Primary|Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups|Participants were categorized in to following age groups: a) <40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years.|Baseline up to 30 months|Included breast cancer tissue samples from all participants who were willing to participate in the study.|||percentage of participants|Tissue samples||Number
2569907|NCT02535026|Primary|Percentage of Participants With ER Status (Positive or Negative) Based on Lymphovascular Invasion|Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.|Baseline up to 30 months|Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.|||percentage of participants|Tissue samples||Number
2569908|NCT02535026|Primary|Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades|Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.|Baseline up to 30 months|Included breast cancer tissue samples from all participants who were willing to participate in the study.|||percentage of participants|Tissue samples||Number
2569909|NCT02535026|Primary|Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups|Participants were categorized in to following age groups: a) less than (<) 40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) greater than or equal to (≥) 70 years.|Baseline up to 30 months|Included breast cancer tissue samples from all participants who were willing to participate in the study.|||percentage of participants|Tissue samples||Number
2569910|NCT02535026|Primary|Percentage of Participants With Histological Sub-types of Breast Cancer|Histological subtypes of breast cancer included ductal carcinoma, lobular carcinoma, mucinous carcinoma, mixed carcinoma, metaplastic carcinoma, and others.|Baseline up to 30 months|Included breast cancer tissue samples from all participants who were willing to participate in the study.|||percentage of participants|Tissue samples||Number
2569911|NCT02535026|Primary|Percentage of Participants With Different Phenotypes of Breast Cancer|Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were estrogen receptor (ER) + and/or progesterone receptor (PR) +, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Histological grading was done by Nottingham Histologic Score system based on three factors, a) the amount of gland formation (differentiation), b) the nuclear features (pleomorphism) and c) the mitotic activity. Each of these features is scored from 1-3, and then each score is added to give a final total score ranging from 3-9. The final total score is used to determine the grade in the following way: i) Grade 1 tumors have a score of 3-5, ii) Grade 2 tumors have a score of 6-7, and iii) Grade 3 tumors have a score of 8-9.|Baseline up to 30 months|Included all breast cancer tissue samples for which the phenotype could be identified.|||percentage of participants|Tissue samples||Number
2569912|NCT02535026|Primary|Percentage of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Status in Breast Cancer Specimens Using Immunohistochemistry (IHC) and Silver In-Situ Hybridization (SISH) Procedures|"HER2 status of the collected tissue samples was determined based on the results obtained from IHC test and SISH procedure. The IHC test gives a score of 0 to 3 positive (+) that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it's called HER2 negative (-). If the score is 2+, it's called borderline. A score of 3+ is called HER2 positive. Tissue samples which had the IHC score of 2+ (borderline) were re-tested using SISH procedure for confirmation of the HER2 status. Tissue samples with SISH test results + were considered as HER2+. Tissue samples for which HER2 status was not determined were considered as HER2 equivocal."|Baseline up to 30 months|Included breast cancer tissue samples from all participants who were willing to participate in the study.|||percentage of participants|Tissue samples||Number
2569913|NCT02534935|Secondary|Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains||Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3)|Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here, N signifies number of participants evaluable for this outcome measure.|||titers||95% Confidence Interval|Geometric Mean
2569914|NCT02534935|Secondary|Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains||Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3)|Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of Participants||95% Confidence Interval|Number
2569948|NCT02534324|Secondary|Number of Participants Who Had Major Hypertensive-related Events After Discharge From the Emergency Department|Participants who had major hypertensive-related events defined by those who had one or more of the followings: acute chest pain, heart failure, acute coronary syndromes, acute aortic syndromes, retinal/vitreous hemorrhage, hypertensive retinopathy, seizure, acute cerebrovascular diseases, hypertensive encephalopathy, which occurred within 7 days after discharge from emergency department.|7 days||||participants|||Number
2569915|NCT02534935|Secondary|Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2|Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).|1 month (Mon) after Vaccination (Vac) 2|"Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here N signifies number of participants evaluable for this outcome measure."|||percentage of Participants||95% Confidence Interval|Number
2569916|NCT02534935|Secondary|Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 3|Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).|1 Month After Vaccination 3|Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here N signifies number of participants evaluable for this outcome measure.|||percentage of Participants||95% Confidence Interval|Number
2569917|NCT02534935|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC)Throughout the Study|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|From Vaccination 1 up to 6 months after Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of Participants||95% Confidence Interval|Number
2569918|NCT02534935|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Follow up Phase|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|From 1 month after Vaccination 3 up to 6 months after Vaccination 3|"Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. Here N signifies number of participants evaluable for this outcome measure."|||percentage of Participants||95% Confidence Interval|Number
2569919|NCT02534935|Primary|Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|From the Vaccination 1 up to 1 month after Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of Participants||95% Confidence Interval|Number
2569920|NCT02534935|Primary|Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|within 30 Days after any Vaccination|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of Participants||95% Confidence Interval|Number
2569927|NCT02534935|Primary|Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3|Local reactions included tenderness at injection site, swelling and redness collected by using an e-diary. Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).|within 7 Days after Vaccination 3|Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of Participants||95% Confidence Interval|Number
2573147|NCT02498821|Secondary|Number of Additional Venous Access Devices (VADs) Required Due to PICC Not Being Ready for Use||Measured from initiation to completion of procedure (usually from 0 to 300 minutes)||||Venous Access Devices (VADs)|||Number
2569921|NCT02534935|Primary|Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 3|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.|within 30 Days after Vaccination 3|Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of Participants||95% Confidence Interval|Number
2569922|NCT02534935|Primary|Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 2|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.|within 30 Days after Vaccination 2|Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of Participants||95% Confidence Interval|Number
2569923|NCT02534935|Primary|Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 1|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.|within 30 Days after Vaccination 1|Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available.|||percentage of Participants||95% Confidence Interval|Number
2569924|NCT02534935|Primary|Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3|Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).|within 7 Days after Vaccination 3|Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of Participants||95% Confidence Interval|Number
2569925|NCT02534935|Primary|Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2|Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).|within 7 Days after Vaccination 2|Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of Participants||95% Confidence Interval|Number
2569926|NCT02534935|Primary|Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1|Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).|within 7 Days after Vaccination 1|Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available.|||percentage of Participants||95% Confidence Interval|Number
2569928|NCT02534935|Primary|Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2|Local reactions included tenderness at injection site, swelling and redness collected by using an e-diary. Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).|within 7 Days after Vaccination 2|Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of Participants||95% Confidence Interval|Number
2569929|NCT02534935|Primary|Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1|Local reactions included tenderness at injection site, swelling and redness collected by using an electronic diary (e-diary). Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 centimeter [cm]), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).|within 7 Days after Vaccination 1|Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
2569930|NCT02534935|Primary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3|Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 percent (%) confidence interval (CIs). LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).|1 month after Vaccination 3|All eligible participants randomized to study received,scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here,overall number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2569931|NCT02534896|Secondary|Good European League Against Rheumatism Responders||Day 15||||Participants|||Count of Participants
2569932|NCT02534896|Secondary|Good/Moderate European League Against Rheumatism Responders||Day 15||||Participants|||Count of Participants
2569933|NCT02534896|Secondary|Good European League Against Rheumatism -Responders||Day 8|intent-to-treat|||Participants|||Count of Participants
2569934|NCT02534896|Primary|Good/Moderate European League Against Rheumatism Responders||week 1|Intent-to-treat population|||Participants|||Count of Participants
2569935|NCT02534883|Secondary|Resistance Score|"Ease of Dilation Per Surgeon on a numeric scale of 1(easier than normal) to 5 (more difficult than normal) with 3 being normal."|At time of procedure.||||units on a scale||Standard Deviation|Mean
2569936|NCT02534883|Secondary|Number of Complications|Count of complications at time of surgery.|At time of procedure.||||complications||Standard Deviation|Mean
2569937|NCT02534883|Secondary|Maximum Dilator Size|The largest cervical dilator that could be passed through the internal cervical os.|At time of procedure.||||millimeters||Standard Deviation|Mean
2569938|NCT02534883|Secondary|Dilation Time in Minutes|Time from beginning of cervical dilation to completion of cervical dilation.|At time of procedure.||||minutes||Standard Deviation|Mean
2569939|NCT02534883|Secondary|Number of Recorded Side Effects.|Secondary aim: to evaluate if cervical ripening with misoprostol reduces side effects|At time of surgery/cervical dilation||||number of side effects out of seven|side effects|Standard Deviation|Mean
2569940|NCT02534883|Primary|Efficacy (Cervical Ripening)|To evaluate the efficacy of two doses of 200ug of misoprostol (for a total of 400ug), administered vaginally, on cervical ripening before diagnostic and operative hysteroscopic procedures in postmenopausal women (amenorrhea greater than 1 year). Efficacy is represented by time to dilation.|At time of surgery/cervical dilation|Outcome measures presented below.|||minutes||Standard Deviation|Mean
2569941|NCT02534493|Secondary|Change in SSS of the BCTQ 2 Month Post-treatment vs Baseline|The secondary efficacy variable is the decrease in Symptoms Severity Scale (SSS) score of the Boston Carpal Tunnel Questionnaire (BCTQ) obtained 2 months after the 28-day CTMD treatment period compared to the Baseline SSS score.|2 months||||point decrease in SSS||Standard Deviation|Mean
2569942|NCT02534493|Primary|Change in SSS of the BCTQ at 28 Days vs Baseline|The primary efficacy variable is the decrease in Symptom Severity Scale (SSS) score of the Boston Carpal Tunnel Questionnaire (BCTQ). The SSS is a patient-reported measure of the severity of the patient's symptoms caused by carpal tunnel syndrome, on a scale of 1 (no symptoms) to 5 (worst symptoms).|28 days|Primary outcome measures were analyzed for unilateral and bilateral subjects combined, but measures were analyzed for unilateral and bilateral subjects separately as well.|||point decrease in SSS||Standard Deviation|Mean
2569943|NCT02534350|Secondary|Percent Change From Study Baseline in FEV1% Predicted Value|FEV1 is defined as forced expiratory volume in the first second.|Baseline; Day 28|Participants in the Full Analysis Set with available data were analyzed.|||percent change||Standard Deviation|Mean
2569944|NCT02534350|Secondary|Time-Weighted Average Change in FLU-PRO Score From Day 1/Baseline Through Day 7|The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms) for the 5-point severity scale and 0 (never) to 4 or more times (always) for the 5-point frequency scale. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.|Up to 7 days|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2569945|NCT02534350|Primary|Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in a Subset of Participants in the Full Analysis Set Whose Duration of RSV Symptoms Prior to the First Dose of Study Drug is ≤ Median||Up to 7 days|Participants in the Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2569949|NCT02534324|Primary|Number of Participants Who Died Within 7 Days After Discharge From the Emergency Department|Number of participants who died from hypertension-related events within 7 days after discharge from the emergency department.|7 days||||participants|||Number
2569950|NCT02534129|Primary|Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria|A blinded observer will quantify degree of dermatitis assigning each half of the radiation field a score from 0 to 4. 0 represents no dermatitis and 4 is severe dermatitis using the RTOG scoring criteria.|8 weeks|All patients were analyzed by blinded observor|||units on a scale||Full Range|Median
2569951|NCT02533999|Other Pre-specified|Glasgow Children's Benefit Inventory (GCBI)|A composite score of GCBI for each patient will be calculated by assigning the individual question responses a numerical value from -2 to +2, then adding these up, dividing by the number of questions (24), and multiplying by 50 to produce a result on a scale from -100 (maximum harm) to+ 100 (maximum benefit) .|At six-months post-operatively|Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.|||scores on a scale||Standard Error|Mean
2569952|NCT02533999|Secondary|Adverse Events (Emergent Visits for Medical Care)|To assess differences in adverse events (emergent visits for medical care) from discharge to 14 days post-operatively in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method.|from discharge to 14 days post-operatively|Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.|||Participants|||Count of Participants
2569953|NCT02533999|Secondary|Days to Resumption of Normal Activities|"To assess differences in other outcomes (time to resumption of normal activities) from discharge to 14 days post-operatively in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method.~Return to normal activity. Normal activity is defined as carrying out the same types and amounts of daily activity as before surgery, even if still associated with fatigue. Activity will be scored as 1, none; 2, very little; 3, mostly normal; 4, normal."|from discharge to 14 days post-operatively|Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.|||Days||95% Confidence Interval|Median
2569954|NCT02533999|Secondary|Days to Resumption of Normal Diet|"To assess differences in other outcomes (time to resumption of normal diet) from discharge to 14 days post-operatively in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method.~Return to normal diet. Normal diet is defined as consumption of the types and amount of food such that another family member would not be able to recognize that the patient had undergone throat surgery. Dietary progression from liquid to soft and solid food will be also documented. Diet will be scored as 1, liquids and soft diet only; 2, some solids; 3, mostly solids; and 4, normal diet."|from discharge to 14 days post-operatively|Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.|||Days||95% Confidence Interval|Median
2569955|NCT02533999|Secondary|Number of Participants Who Experienced Bleeding Between 24 Hours and 14 Days Post-operatively (Secondary Period)|"To assess differences in bleeding (hemorrhage) rate (either Level I, Level II, or Level III) between 24 hours and 14 days post-operatively (secondary period) in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method.~Post-operative bleeding will be scored as follows:~Level I. All children who report to have any history of postoperative hemorrhage, whether or not there is clinical evidence.~Level II. All children who require inpatient admission for postoperative hemorrhage regardless of the need for operative intervention. Level III. All children who require a return to the operating department for control of postoperative bleeding."|between 24 hours and 14 days post-operatively (secondary period)|Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.|||Participants|||Count of Participants
2569956|NCT02533999|Secondary|Number of Participants Who Experienced Bleeding Intraoperatively and 24 Hours Post-surgery (Primary Period)|"To assess differences in bleeding (hemorrhage) rate (either Level I, Level II, or Level III) intraoperatively and 24 hours post-surgery (primary period) in children ages 3 to 18 years undergoing adenotonsillectomy with a diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method.~Post-operative bleeding will be scored as follows:~Level I. All children who report to have any history of postoperative hemorrhage, whether or not there is clinical evidence.~Level II. All children who require inpatient admission for postoperative hemorrhage regardless of the need for operative intervention.~Level III. All children who require a return to the operating department for control of postoperative bleeding."|intraoperatively and 24 hours post-surgery (primary period)|Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.|||Participants|||Count of Participants
2569970|NCT02533505|Secondary|Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Spirometry.|FEV1/FVC. For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.|ΔFEV1/FVC calculated as ratio.|||ratio||95% Confidence Interval|Least Squares Mean
2570700|NCT02527148|Secondary|Knee Pain|Pain at rest and pain during mobilization was measured using a 10 centimeter Visual Analogue Scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.|Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively|||||||
2569957|NCT02533999|Primary|Pain Control Assessed by Validated Pain Scores: Days to Having no Pain Following Surgery|"To assess differences in pain control, assessed by validated pain scores and requirement for postoperative analgesia, during the 14-day post-operative period in children ages 3 to 18 years undergoing adenotonsillectomy with a clinical diagnosis of sleep-disordered breathing using the traditional Extracapsular Electrocautery Dissection Method versus the Peak® Surgery System Method.~Assessment of subjective pain. The child will be asked by the parent to grade severity of pain daily using the Wong-Baker FACES pain rating scale in the morning before eating, drinking, or taking analgesics. The Wong-Baker FACES pain rating scale is a 0 to 10 numerical rating scale (0, 2, 4, 6, 8, 10) with faces indicating the level of pain from a happy face at a score of 0 to a crying face at a score of 10. The scale is recommended for children 3 years and older.~Type and frequency of pain medication will be recorded."|during the 14-day post-operative period|Patients aged 3- to 17-years scheduled for adenotonsillectomy with a clinical diagnosis of sleep disordered breathing, or obstructive sleep apnea with adenotonsillar hypertrophy, or recurrent adenotonsillitis were enrolled between October 2013 and June 2015.|||Days||95% Confidence Interval|Median
2569958|NCT02533921|Secondary|Changes in Caregiver Depression|The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in caregiver depression. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21.|0 to 6 months|Available case data for for HADS Anxiety for caregiver. Only applicable when a caregiver is present. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months.|||score on a scale||95% Confidence Interval|Mean
2569959|NCT02533921|Secondary|Changes in Caregiver Anxiety|The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in caregiver anxiety. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21.|0 to 6 months|Available case data for for HADS Anxiety for caregiver. Only applicable when a caregiver is present. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months.|||score on a scale||95% Confidence Interval|Mean
2569960|NCT02533921|Secondary|Changes in Patient Depression|The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in patient depression. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21.|0 to 6 months|Available case data for for HADS Depression. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months.|||score on a scale||95% Confidence Interval|Mean
2569961|NCT02533921|Secondary|Changes in Patient Anxiety|The Hospital Anxiety and Depression Scale (HADS) will be used to quantify changes in patient anxiety. Higher numbers indicate worse outcomes. Scale ranges from 0 to 21.|0 to 6 months|Available case data for for HADS Anxiety. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months.|||score on a scale||95% Confidence Interval|Mean
2569962|NCT02533921|Primary|Changes in Caregiver Distress|The Zarit Caregiver Burden Interview Form (ZBI) will be used to measure differences in Caregiver Distress between groups. Higher scores indicate worse outcomes. Scale ranges from 0 to 48.|0 to 6 months|Available case data for for ZBI. Applicable only when a caregiver is present. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months.|||score on a scale||95% Confidence Interval|Mean
2569963|NCT02533921|Primary|Changes in the Subjects Quality of Life (QOL)|The QOL-AD (Quality of Life in Alzheimer's Disease) survey will be used to measure the differences in the quality of life between groups.Higher numbers indicate better outcomes. The scale ranges from 4 to 52.|0 to 6 months|Available case data for for QOL AD. Longitudinal regression model for all time points. Main outcome is the change from baseline at 6 months.|||score on a scale||95% Confidence Interval|Mean
2569964|NCT02533726|Secondary|Compliance With Patient Turning Procedures|Compliance is reported as the percentage of time during ICU admission that patients received turning every two hours.|Duration of ICU admission (average 1 week)|Per protocol population according to treatment received (met minimum monitoring period (>2h) and did not receive both interventions)|||percentage of time||Standard Deviation|Mean
2569965|NCT02533726|Primary|Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers|"NPUAP criteria include 4 stages and 2 unstaged criteria. The count of patients with pressure ulcer according to any of the criteria are reported.~Stage 1: Non-blanchable erythema of intact skin~Stage 2: Partial-thickness skin loss with exposed dermis~Stage 3: Full-thickness skin loss~Stage 4: Full-thickness skin and tissue loss~Unstageable: Obscured full-thickness skin and tissue loss~Suspected deep tissue injury: Persistent non-blanchable deep red, maroon or purple discoloration"|Duration of ICU admission (average 1 week)|Per protocol population according to treatment received (met minimum monitoring period (>2h) and did not receive both interventions)|||Participants|||Count of Participants
2569966|NCT02533570|Secondary|Proportion of Subjects Achieving an SRI Response at Day 85|"Assessment for response was made using data only for the visit of interest (Day 85), without regard for changes at prior on-treatment visits.~SRI: SLE Responder Index; SLE: Systemic lupus erythematosus"|85 days||||Participants|||Count of Participants
2569967|NCT02533570|Primary|Number and Percentage of Subjects Having an Adverse Event (AE)|Any treatment-emergent adverse events (TEAEs), any drug-related TEAEs, any SAEs, treatment-related serious adverse events (SAE), deaths, adverse events (AEs) leading to study discontinuation, and number of patients experiencing Grade 1, 2, and 3 TEAEs.|Up to 127 days (9 weeks after final dose)||||Participants|||Count of Participants
2569968|NCT02533531|Secondary|Composite Outcome Measure - Adhesive Performance - Measurement of Skin Irritation Resulting From Adhesive Used With 1-Lead Patch|Successful performance of the 1-Lead Patch adhesive throughout the study period for each subject. Subject skin irritation will be assessed upon initial placement of the 1-Lead Patch by the clinical caregiver. Subjects will be asked to self-assess skin irritation and to report to the clinician at the end of the trail period. Data were not collected.|Between 7 and 14 days|Data were not collected.||||||
2569969|NCT02533531|Primary|Composite Outcome Measure - 100% Successful ECG Acquisition|Successful acquisition of ECG data by the 1-Lead patch with transmission to the central database via the gateway. Each patch includes a 'brain' that collects the ECG data and then transmits it to a cellular device called the 'gateway'. The gateway uses the cellular network to transmit the data to the central database. This is a composite outcome measure. Data were not collected.|Between 7 and 14 days|Data were not collected.||||||
2569971|NCT02533505|Secondary|Change in Ve|Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in minute ventilation (Ve). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.|Units of measure: ΔVe: mL/min.|||mL/min||95% Confidence Interval|Least Squares Mean
2569972|NCT02533505|Secondary|Change in Vt|Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in tidal volume (Vt). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.|Units of measure: ΔVt: mL|||mL||95% Confidence Interval|Least Squares Mean
2569973|NCT02533505|Secondary|Change in Ti/Ttot|Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in fractional inspiratory time (Ti/total cycle time [Ttot]). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.|ΔTi/Ttot is measured as a ratio.|||ratio||95% Confidence Interval|Least Squares Mean
2569974|NCT02533505|Secondary|Change in RR|For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.|ΔRR: breaths/min|||breaths/min||95% Confidence Interval|Least Squares Mean
2569975|NCT02533505|Secondary|Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Gas Exchange Parameter SaO2|For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.||||SaO2: %||95% Confidence Interval|Least Squares Mean
2569976|NCT02533505|Secondary|Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Gas Exchange Parameter VCO2|For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.||||ΔVCO2: mL/min||95% Confidence Interval|Least Squares Mean
2569977|NCT02533505|Secondary|Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in the Modified Borg Scale for Dyspnea|For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo). Modified Borg scale for dyspnea was self-administered at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21). The Borg scale is a 1-item instrument through which a subject reports dyspnea symptoms on a scale of 0-10 to quantify the intensity of dyspnea (where 10 is most intense).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.||||units on a scale||95% Confidence Interval|Least Squares Mean
2569978|NCT02533505|Secondary|Change in Vt/Ti|Change from pre-dose (Visit 2) to post-dose (Visit 5) assessment in mean inspiratory flow (tidal volume [Vt]/inspiratory time [Ti]). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.|Units of measure: Vt/Ti: mL/sec|||mL/sec||95% Confidence Interval|Least Squares Mean
2569979|NCT02533505|Secondary|Change From Pre-dose (Visit 2)to Post-dose (Visit 5) Assessment in Spirometry.|Forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), and IC (using an slow vital capacity [SVC] maneuver; IC/total lung capacity [TLC] will be used as a measure of resting hyperinflation). For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.||||FEV1: L; ΔFVC: L; ΔIC: L||95% Confidence Interval|Least Squares Mean
2570053|NCT02533063|Other Pre-specified|Adherence and Factors That Influence Adherence-Exercise Enjoyment|"Exercise enjoyment for each intervention was assessed using the validated questionnaire, 5-point Likert scale. Response options include strongly agree, agree, neutral, disagree, strongly agree."|This was collected at the end of each 8 week intervention period.||||percentage of participants|||Number
2569980|NCT02533505|Secondary|Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Gas Exchange Parameter HR|For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.||||ΔHR: beats/min||95% Confidence Interval|Least Squares Mean
2569981|NCT02533505|Secondary|Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Oxygen Pulse (Defined as VO2/Heart Rate [HR]; VO2 is Obtained Via a Metabolic Cart; Used as a Surrogate for Stroke Volume)|For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.||||mL/min/beats/min||95% Confidence Interval|Least Squares Mean
2569982|NCT02533505|Primary|Change From Pre-dose (Visit 2) to Post-dose (Visit 5) Assessment in Oxygen Consumption (VO2; Obtained Via a Metabolic Cart)|For all outcome measures, treatment group estimates are LS Means across visits (change between 2 or more time points, calculated as the value at the later time point minus the value at the earlier time point, e.g. LS means across visits up to Visit 5 minus pre-dose Visit 2 value). Estimate for difference = LS Mean (Symbicort pMDI 160mcg/4.5ug) - LS Mean (placebo).|Assessment (60 minutes pre and post dose) at Visit 2 (Day 0), Visit 3 (Day 7), Visit 4 (Day 14), and Visit 5 (Day 21); change from baseline pre-dose to Day 21 post-dose reported.||||mL/min||95% Confidence Interval|Least Squares Mean
2569983|NCT02533466|Secondary|Change From Baseline in Buffering Capacity 7 Hours Post Dietary Acid Challenge|Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.|Baseline, 7 hours post dietary acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.|||scores on a scale||Standard Deviation|Mean
2569984|NCT02533466|Secondary|Change From Baseline in Buffering Capacity at 30 Mins Post Dietary Acid Challenge|Saliva was collected and stored at 0 - 20°C. A Saliva-check Buffer Kit was used to determine the buffer capacity. The colourimetric assay yielded a coloured pattern on a paper diagnostic using a 0-12 scale where 0-5 was deemed to be very low, 6-9 was deemed low and 10-12 was deemed normal-high.|Baseline, 30 mins post dietary acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.|||scores on a scale||Standard Deviation|Mean
2569985|NCT02533466|Secondary|Change From Baseline of pH Measurement 7 Hours Post Dietary Acid Challenge|Saliva stored at 0 - 20°C was used for determining pH|Baseline, 7 hours post dietary acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population|||pH units||Standard Deviation|Mean
2569986|NCT02533466|Secondary|Change From Baseline of pH Measurement at 30 Mins Post Dietary Acid Challenge|Saliva stored at 0 - 20°C was used for determining pH|Baseline, 30 mins post dietary acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population|||pH units||Standard Deviation|Mean
2569987|NCT02533466|Secondary|Change From Baseline of Salivary Calcium Concentration 7 Hours Post Dietary Acid Challenge|Saliva stored at 0 - 20°C was used for determining calcium concentration|Baseline, 7 hours post dietary acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.|||ppm||Standard Deviation|Mean
2569988|NCT02533466|Secondary|Change From Baseline of Salivary Calcium Concentration at 30 Mins Post Dietary Acid Challenge|Saliva stored at 0 - 20°C was used for determining calcium concentration|Baseline, 30 mins post dietary acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation was excluded from PP analyses. The primary population was the PP population.|||ppm||Standard Deviation|Mean
2569989|NCT02533466|Secondary|Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 7 Hours Post Acid Challenge|"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.~The Images were graded as follows:~- No signs of surface erosive wear (no evidence of the lock and key structure)~- Early signs of erosive surface changes~- Mild signs of erosive surface changes (early signs of the lock and key structure).~- Moderate signs of erosive surface changes~- Severe signs of erosive surface changes (lock and key structure and enamel pits) X - Not evaluable"|Baseline, 7 hours post acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.|||Scores on grading scale||Full Range|Median
2573862|NCT02489357|Other Pre-specified|Expression of PD-L1|Number of participants with PD-L1 expression in tumor tissue.|Baseline|1 participant refused biopsy. Only 2/11 samples were evaluable for this outcome measure.|||Participants|||Count of Participants
2569990|NCT02533466|Secondary|Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 4 Hours Post Acid Challenge|"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.~The Images were graded as follows:~- No signs of surface erosive wear (no evidence of the lock and key structure)~- Early signs of erosive surface changes~- Mild signs of erosive surface changes (early signs of the lock and key structure).~- Moderate signs of erosive surface changes~- Severe signs of erosive surface changes (lock and key structure and enamel pits) X - Not evaluable"|Baseline, 4 hours post acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.|||Scores on grading scale||Full Range|Median
2569991|NCT02533466|Secondary|Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Following 2 Hours Post Acid Challenge.|"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.~The Images were graded as follows:~- No signs of surface erosive wear (no evidence of the lock and key structure)~- Early signs of erosive surface changes~- Mild signs of erosive surface changes (early signs of the lock and key structure).~- Moderate signs of erosive surface changes~- Severe signs of erosive surface changes (lock and key structure and enamel pits) X - Not evaluable"|Baseline, 2 hours post acid challenge|The PP population was defined as those subjects in the ITT population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.|||Scores on grading scale||Full Range|Median
2569992|NCT02533466|Primary|Change From Pre-acid Challenge (Baseline) Tooth Impression Grading Score Immediately Following an Acid Challenge|"The impressions of the tooth surface were analysed using scanning electron microscopy (SEM) to investigate changes in the enamel surface topography to determine degree of early stage enamel erosion. Interrogation of the tooth surface via impressions using SEM followed by visual image analysis was used to investigate the enamel surface topography.~The Images were graded as follows:~- No signs of surface erosive wear (no evidence of the lock and key structure)~- Early signs of erosive surface changes~- Mild signs of erosive surface changes (early signs of the lock and key structure).~- Moderate signs of erosive surface changes~- Severe signs of erosive surface changes (lock and key structure and enamel pits) X - Not evaluable"|Baseline, 30 minutes post dietary acid challenge|The Per Protocol (PP) population was defined as those subjects in the ITT (intent to treat) population who have at least one assessment of efficacy considered unaffected by protocol violation. Assessments of efficacy considered affected by protocol violation were excluded from PP analyses. The primary population was the PP population.|||Scores on grading scale||Full Range|Median
2569993|NCT02533453|Secondary|"Evaluation of Subjective Improvement of Main Indication"|"Subjective improvement of main indication will be assessed as improved, slightly improved, unchanged, aggravated, or unable to evaluate."|baseline and 12/24 weeks|Of 110 subjects, 104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded. Of 104 subjects, 1 subject who failed to receive the efficacy analysis was excluded, and 103 were included in the efficacy set.|||participants|||Number
2569994|NCT02533453|Secondary|Change in Vital Sign|Change in vital sign at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)|baseline and 12/24 weeks|Of 110 subjects, 104 were included in the safety set with 5 subjects of non-treatment with the study drug, 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded.|||mmHg||Standard Deviation|Mean
2569995|NCT02533453|Secondary|Change in Body Weight|Change in body weight at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)|baseline and 12/24 weeks|Of 110 subjects, 104 were included in the safety set with 5 subjects of non-treatment with the study drug, 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded.|||kg||Standard Deviation|Mean
2569996|NCT02533453|Secondary|Change in Fasting Plasma Gloucose|Change in Fasting plasma gloucose at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)|baseline and 12/24 weeks|Of 110 subjects, 104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded. Of 104 subjects, 1 subject who failed to receive the efficacy analysis was excluded, and 103 were included in the efficacy set.|||mg/dL||Standard Deviation|Mean
2569997|NCT02533453|Secondary|Change in HbA1c|Change in HbA1c at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)|baseline and 12/24 weeks|Of 110 subjects, 104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded. Of 104 subjects, 1 subject who failed to receive the efficacy analysis was excluded, and 103 were included in the efficacy set.|||percentage of Hba1c||Standard Deviation|Mean
2569998|NCT02533453|Primary|Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs)|was to estimate the incidence rates of adverse events (AEs) and serious adverse events (SAEs) in patients who are treated with 2 mg exenatide once weekly for type 2 diabetes mellitus in the normal clinical practice setting over a period of 12/24 weeks for long-term surveillance.|baseline and 12/24 weeks|Of 110 subjects, 104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded.|||percentage of participants||95% Confidence Interval|Number
2570407|NCT02530385|Primary|Percent Change From Baseline in Insulin Resistance Based on Insulin-Stimulated Glucose Uptake (M) During Hyperinsulinemic Euglycemic Clamp||Baseline and 6 weeks|2 participants in the FMT Capsules group did not complete the 6 week study visit: 1 withdrew prior to the visit; 1 missed due to a scheduling issue.|||percent change||Standard Deviation|Mean
2569999|NCT02533401|Primary|Percentage of Participants With Complete Response (CR), Nodular Partial Response (nPR), or Partial Response (PR)|Treatment response was monitored throughout the study and assessed using standardized criteria. CR was defined as hemoglobin ≥11 grams per deciliter (g/dL), lymphocytes less than (<) 4000 cells per cubic millimeter (cells/mm^3), neutrophils greater than (>) 1500 cells/mm^3, platelets >100,000 cells/mm^3, bone marrow (BM) biopsy with <30% lymphocytes with no lymphocytic infiltrates, no evidence of lymphoid nodules on physical exam, and performance status of 0. PR was defined as >50% decrease in size of enlarged lymph nodes, hepatomegaly, and splenomegaly, with peripheral counts meeting the same criteria as CR or ≥50% improvement from pre-treatment values. Participants with lymphoid nodules on BM biopsy who otherwise met CR criteria were considered nPR. The percentage of participants with each level of best overall response was calculated.|Up to 4 years (assessed every 3 months during 6-month treatment period, every 2 months during 6-month safety follow-up, then every 3 months during 3-year safety follow-up)|All Participants Enrolled.|||percentage of participants|||Number
2570000|NCT02533401|Primary|Overall Survival (OS)|Participants were followed for survival throughout the study. OS was defined as the time from study inclusion until death from any cause and was estimated using Kaplan-Meier analysis|Up to 5 years (from Baseline until death)|All Participants Enrolled.|||months||95% Confidence Interval|Mean
2570001|NCT02533401|Primary|Percentage of Participants Who Died|Participants were followed for survival throughout the study. The percentage of participants who died of any cause during the study was calculated.|Up to 5 years (from Baseline until death)|All Participants Enrolled.|||percentage of participants|||Number
2570002|NCT02533401|Primary|Progression-Free Survival (PFS)|Treatment response was monitored throughout the study and assessed using standardized criteria. Disease progression was defined as the occurrence of at least one of the following: ≥50% increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 cm from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes. PFS was defined as the time from study inclusion until first event of disease progression or death and was estimated using Kaplan-Meier analysis.|Up to 5 years (from Baseline until disease progression or death, whichever occurred first)|All Participants Enrolled.|||months||95% Confidence Interval|Mean
2570003|NCT02533401|Primary|Percentage of Participants With Death or Disease Progression|Treatment response was monitored throughout the study and assessed using standardized criteria. Disease progression was defined as the occurrence of at least one of the following: greater than or equal to (≥) 50 percent (%) increase in the longest diameter of at least two enlarged lymph nodes, increase in spleen and/or liver size by at least 2 centimeters (cm) from Baseline as determined by measurement below the costal margin, or ≥50% increase in the number of circulating lymphocytes. The percentage of participants with death or documented disease progression at any time during the study was calculated.|Up to 5 years (from Baseline until disease progression or death, whichever occurred first)|All Participants Enrolled.|||percentage of participants|||Number
2570004|NCT02533375|Secondary|Proportion of Participants Taking Topical Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study|Participants using topical co-medications for GPP were documented at each scheduled study visit.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52|Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment|||Participants|||Count of Participants
2570005|NCT02533375|Secondary|Proportion of Participants Taking Systemic Co-medication for Generalized Pustular Psoriasis (GPP) at Any Time During the Study|GPP-specific co-medications were documented at each scheduled study visit.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52|Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment|||Participants|||Count of Participants
2570006|NCT02533375|Secondary|Mean Change From Baseline in Short Form-36 Health Status Survey Version 2 (SF-36 V2) Score Over Time|The Short Form-36 Health Status Survey Version 2 (SF-36 V2) is a 36-item generic health-related quality of life questionnaire to assess the participant's view of their health consisting of 2 components: physical and mental. For each component, a transformed summary score is calculated using 8 sub-domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores range from 0 to 100. Higher scores indicate a better health state.|Baseline, Week 8, Week 16, Week 24, Week 36, Week 52|Participants with available data|||units on a scale||Standard Deviation|Mean
2570007|NCT02533375|Secondary|Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment- related feelings. Participants respond to 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Negative values indicate improvement from baseline.|Baseline, Week 8, Week 16, Week 24, Week 36, Week 52|Participants with available data|||units on a scale||Standard Deviation|Mean
2570008|NCT02533375|Secondary|Proportion of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 Over Time|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment- related feelings. Participants respond to 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.|Week 8, Week 16, Week 24, Week 36, Week 52|Participants with available data|||Participants|||Count of Participants
2570119|NCT02532647|Secondary|Time to Fully Alert|Time to first of 3 Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scores of 5 after the end of colonoscopy procedure (colonoscope out) and after the last injection of study drug|From the last injection of the study drug AND from end of colonoscopy until the patient has recovered to fully alert|Patients who did not reach the endpoint are censored at last observation.|||minutes||95% Confidence Interval|Median
2570009|NCT02533375|Secondary|Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time|The percent change in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Negative values indicate improvement from baseline.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||percentage change from baseline||Standard Deviation|Mean
2570010|NCT02533375|Secondary|Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score Over Time|The mean change in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Negative values indicate improvement from baseline.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||units on a scale||Standard Deviation|Mean
2570011|NCT02533375|Secondary|Proportion of Participants Achieving Psoriasis Area and Severity Index 50 (PASI 50) Over Time|The proportion of participants with a ≥ 50% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||Participants|||Count of Participants
2570012|NCT02533375|Secondary|Proportion of Participants Achieving Psoriasis Area and Severity Index 75 (PASI 75) Over Time|The proportion of participants with a ≥ 75% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||Participants|||Count of Participants
2570013|NCT02533375|Secondary|Proportion of Participants Achieving Psoriasis Area and Severity Index 90 (PASI 90) Over Time|The proportion of participants with a ≥ 90% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed for erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||Participants|||Count of Participants
2570014|NCT02533375|Secondary|Proportion of Participants Achieving Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade 0 or 1 for Those With PGA Grade of at Least 2 at Baseline Over Time|The Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall severity was evaluated using the following categories: erythema, pustulation, and edema, and graded as follows. Grade 0 = cleared, except for residual discoloration; Grade 1 = minimal; Grade 2 = mild; Grade 3 = moderate; Grade 4 = severe; and Grade 5 = very severe. The score is an arithmetic average of the grades for erythema, pustulation, and edema, rounded to the nearest whole number.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||Participants|||Count of Participants
2570015|NCT02533375|Secondary|Change From Baseline in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Grade Over Time|The Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall severity was evaluated using the following categories: erythema, pustulation, and edema, and graded as follows. Grade 0 = cleared, except for residual discoloration; Grade 1 = minimal; Grade 2 = mild; Grade 3 = moderate; Grade 4 = severe; and Grade 5 = very severe. The score is an arithmetic average of the grades for erythema, pustulation, and edema, rounded to the nearest whole number.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||Participants|||Count of Participants
2570016|NCT02533375|Secondary|Proportion of Participants Achieving Treatment Success in Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) Over Time|The Physician's Global Assessment of Generalized Pustular Psoriasis (PGA-GPP) is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall severity was evaluated using the following categories: erythema, pustulation, and edema, and graded as follows. Grade 0 = cleared, except for residual discoloration; Grade 1 = minimal; Grade 2 = mild; Grade 3 = moderate; Grade 4 = severe; and Grade 5 = very severe. The score is an arithmetic average of the grades for erythema, pustulation, and edema, rounded to the nearest whole number. Treatment Success was defined by at least a 2 grade improvement relative to baseline.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||Participants|||Count of Participants
2570408|NCT02530294|Secondary|Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4||From Baseline to Week 4|Participant|||percent of subjects|||Number
2570017|NCT02533375|Secondary|"Number of Participants Achieving Mild in the JDA Severity Index of Generalized Pustular Psoriasis (GPP) for Participants With Moderate or Severe at Baseline Over Time"|"The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score ([range 0-8, with 8 representing severe disease] assesses body temperature, white blood cell [WBC] count, high-sensitivity C-reactive protein [hs-CRP], and serum albumin). A total score on the JDA severity index of 0-6 is categorized as Mild, Moderate is 7-10, and Severe is 11-17."|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||Participants|||Count of Participants
2570018|NCT02533375|Secondary|Mean Change From Baseline in Serum Albumin Over Time|Blood was drawn at each study visit, and serum albumin concentration was determined.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||g/dL||Standard Deviation|Mean
2570019|NCT02533375|Secondary|Mean Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Over Time|Blood was drawn at each study visit, and high-sensitivity C-reactive protein (hs-CRP) concentration was determined.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||mg/dL||Standard Deviation|Mean
2570020|NCT02533375|Secondary|Mean Change From Baseline in White Blood Cell (WBC) Concentration Over Time|Blood was drawn at each study visit, and white blood cell concentration was determined.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||cells/µL||Standard Deviation|Mean
2570021|NCT02533375|Secondary|Mean Change From Baseline in Body Temperature Over Time|Body temperature (oral) was obtained at each visit prior to blood sampling.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||degrees Celsius||Standard Deviation|Mean
2570022|NCT02533375|Secondary|Mean Change From Baseline in Total Edema Area Over Time|The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of edema (swelling) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total area of edema is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 50%; moderate, ≥ 10% and < 50%; mild, < 10%); and none (0%). Negative values indicate improvement from baseline.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||units on a scale||Standard Deviation|Mean
2570023|NCT02533375|Secondary|Mean Change From Baseline in Total Erythema Area With Pustules Over Time|The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of erythema with pustules (small pockets of pus) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total erythema area with pustules is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 50%; moderate, ≥ 10% and < 50%; mild, < 10%); and none (0%). Negative values indicate improvement from baseline.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||units on a scale||Standard Deviation|Mean
2570024|NCT02533375|Secondary|Mean Change From Baseline in Total Erythema Area Over Time|The Generalized Pustular Psoriasis (GPP) skin score scores for the total area of erythema (redness) were calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total erythema area is evaluated on a scale of 0 (none) to 3 (severe), with the percentage of body surface area involvement defined as follows: severe ≥ 75%; moderate, ≥ 25% and < 75%; mild, < 25%); and none (0%). Negative values indicate improvement from baseline.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||units on a scale||Standard Deviation|Mean
2570025|NCT02533375|Secondary|Mean Change From Baseline in Total Systemic/Laboratory Test Score Over Time|The Generalized Pustular Psoriasis (GPP) total systemic/laboratory test score ([range 0-8, with 8 representing severe disease] assesses body temperature, white blood cell [WBC] count, high-sensitivity C-reactive protein [hs-CRP], and serum albumin). Negative values indicate improvement from baseline.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||units on a scale||Standard Deviation|Mean
2570026|NCT02533375|Secondary|Mean Percent Change From Baseline in Total Skin Score Over Time|The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Negative values indicate improvement from baseline.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||percentage change from baseline||Standard Deviation|Mean
2570027|NCT02533375|Secondary|Mean Change From Baseline in Total Skin Score Over Time|The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Negative values indicate improvement from baseline.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||units on a scale||Standard Deviation|Mean
2570036|NCT02533258|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non--serious events.|From initiation of axitinib treatment up to end of the study (up to 40 months)|Safety population included all the enrolled participants who received at least one dose of the axitinib.|||participants|||Number
2570028|NCT02533375|Secondary|Mean Change From Baseline in JDA Severity Index of GPP Over Time|"The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score ([range 0-8, with 8 representing severe disease] assesses body temperature, white blood cell [WBC] count, high-sensitivity C-reactive protein [hs-CRP], and serum albumin). A total score on the JDA severity index of 0-6 is categorized as Mild, Moderate is 7-10, and Severe is 11-17."|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment|||Participants|||Count of Participants
2570029|NCT02533375|Secondary|Mean Change From Baseline in the Total GPP Score Over Time|The Generalized Pustular Psoriasis (GPP) total score (range 0-17, with 17 representing severe disease) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score (range 0-9, with 9 representing severe symptoms) is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). The systemic and laboratory results score ([range 0-8, with 8 representing severe disease] assesses body temperature, white blood cell [WBC] count, high-sensitivity C-reactive protein [hs-CRP], and serum albumin). Negative values indicate improvement from baseline.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Participants with available data|||units on a scale||Standard Deviation|Mean
2570030|NCT02533375|Secondary|Number of Participants Achieving Clinical Remission Over Time|The Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) was calculated according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical remission was defined as a total skin score of 0.|Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 52|Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment; non-responder imputation was used for participants with missing data|||participants|||Number
2570031|NCT02533375|Secondary|Number of Participants Achieving Clinical Response Over Time|Clinical Response was defined as reduction of the Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) relative to baseline (Day 1), according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical Response was defined as the improvement (reduction) of total skin score of at least 1 point (if the participant's baseline total skin score was 3); improvement (reduction) at least 2 points (if the participant's baseline total skin score was 4-9); or remission if the total skin score was 0.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment; non-responder imputation was used for participants with missing data|||participants|||Number
2570032|NCT02533375|Primary|Proportion of Participants Achieving Clinical Response at Week 16|Clinical Response was defined as reduction of the Generalized Pustular Psoriasis (GPP) total skin score (range 0-9, with 9 representing severe symptoms) relative to baseline (Day 1), according to Japan Dermatology Association (JDA) severity index in GPP medical care guideline 2014. The total skin score is the combined skin scores for area of erythema (redness), area of erythema with pustules (small pockets of pus), and area of edema (swelling). Clinical Response was defined as the improvement (reduction) of total skin score of at least 1 point (if the participant's baseline total skin score was 3); improvement (reduction) at least 2 points (if the participant's baseline total skin score was 4-9); or remission if the total skin score was 0.|Baseline and Week 16|Full Analysis Set (FAS): all participants who received at least 1 dose of study drug and had at least 1 post-treatment efficacy assessment; non-responder imputation was used for participants with missing data|||Participants|||Count of Participants
2570033|NCT02533258|Secondary|Number of Participants Discontinued Due to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|From initiation of axitinib treatment up to end of the study (up to 40 months)|Safety population included all the enrolled participants who received at least one dose of the axitinib. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.|||partcicipants|||Number
2570034|NCT02533258|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs)|A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.|From initiation of axitinib treatment up to end of the study (up to 40 months)|Safety population included all the enrolled participants who received at least one dose of the axitinib. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.|||participants|||Number
2570035|NCT02533258|Secondary|Number of Participants With Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE.|From initiation of axitinib treatment up to end of the study (up to 40 months)|Safety population included all the enrolled participants who received at least one dose of the axitinib. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.|||participants|||Number
2570052|NCT02533063|Other Pre-specified|Adherence and Factors That Influence Adherence-Pain|"Self-reported pre- and post-training pain during the vibration intervention and control sessions were calculated as the mean for each participant using a validated questionnaire, Comprehensive Pain Assessment Form with scale from 0-10, 0 being no pain and 10 being severe pain."|This was collected before and after training during each of the 8 week interventions.||||percentage of participants|||Number
2570037|NCT02533258|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time duration in months from start of study treatment to the first documentation of PD or to death due to any cause, whichever occured first. PD was assessed by RECIST version 1.1. and defined as >=20% increase in the sum of the diameters of the target lesions taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Progression free survival based on investigators' judgment on medical records was calculated.|From initiation of axitinib treatment until PD or death from any cause (up to 40 months)|Efficacy population included all the participants who were enrolled in the study.|||months||95% Confidence Interval|Median
2570038|NCT02533258|Secondary|Duration of Response|Duration of response was defined as time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions and all lymph nodes decreased to non-pathological in size (<10 mm short axis). PR was defined as at least 30% decrease in sum of diameters of target lesions taking as reference the baseline sum, without progression of non-target lesions, no appearance of new lesions. PD was defined as >=20% increase in sum of diameters of the target lesions taking as a reference smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions.|From initiation of axitinib treatment until PD or death from any cause (up to 40 months)|Efficacy population included all the participants who were enrolled in the study. Here 'number of participants analyzed' signifies participants who achieved a confirmed CR or PR.|||months||95% Confidence Interval|Median
2570039|NCT02533258|Secondary|Objective Response Rate (ORR)|ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version 1.1. CR was defined as disappearance of all target, non-target lesions and all lymph nodes decreased to non-pathological in size (less than [<]10 millimeter [mm] short axis). PR was defined as at least 30 percent (%) decrease in sum of diameters of target lesions taking as reference the baseline sum, without progression of non-target lesions, no appearance of new lesions. Progression of disease (PD) was defined as greater than equal to (>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Response evaluation was based on investigators' judgment.|From initiation of axitinib treatment until PD or death from any cause (up to 40 months)|Efficacy population included all the participants who were enrolled in the study.|||percentage of participants|||Number
2570040|NCT02533258|Primary|Mean Daily Dose of Axitinib||From initiation of axitinib treatment up to the end of the study (up to 40 months)|Efficacy population included all the participants who were enrolled in the study.|||milligram||Standard Deviation|Mean
2570041|NCT02533258|Primary|Duration of Axitinib Treatment||From initiation of axitinib treatment up to the end of the study (up to 40 months)|Efficacy population included all the participants who were enrolled in the study.|||months||95% Confidence Interval|Median
2570042|NCT02533167|Other Pre-specified|Maternal Satisfaction-operating Room|maternal satisfaction with operating room atmosphere will be evaluated on post delivery day 1 utilizing a 100mm sliding scale VAS 0= not satisfied at all up to 100= extremely satisfied|24 hours||||units on a scale||Standard Deviation|Mean
2570043|NCT02533167|Other Pre-specified|Maternal Satisfaction With Postoperative Pain Control|with pain control at 24 hours postoperative will be evaluated on post delivery day 1 utilizing a 100mm sliding scale VAS 0= not satisfied at all up to 100= extremely satisfied|24 hours||||units on a scale||Standard Deviation|Mean
2570044|NCT02533167|Other Pre-specified|Maternal Satisfaction With Pain Control in the Operating Room|with pain control in the operating room will be evaluated on post delivery day 1 utilizing a 100mm sliding scale VAS 0= not satisfied at all up to 100= extremely satisfied|24 hours||||units on a scale||Standard Deviation|Mean
2570045|NCT02533167|Other Pre-specified|Maternal Satisfaction With Anesthesia Care|maternal satisfaction with anesthesia care will be evaluated on post delivery day 1 utilizing a 100mm sliding scale where VAS 0= not satisfied at all up to 100= extremely satisfied|up to 24 hours||||units on a scale||Standard Deviation|Mean
2570046|NCT02533167|Other Pre-specified|Morphine Usage|24 hour morphine equivalents required in the operating room up to the initial 24 hours after delivery for pain management|up to 24 hours||||mg of morphine||Standard Deviation|Mean
2570047|NCT02533167|Primary|Maternal Evoked Pain Scores|maternal evoked pain is evaluated utilizing a 100 mm Sliding VAS scale with 0=no pain through 100=most severe pain ever|up to 24 hours||||units on a scale||Standard Deviation|Mean
2570048|NCT02533089|Secondary|Proportion of Successes Among HIV Co-infected Cases|secondary outcome = proportion of successes among HIV co-infected cases|1 year|analysis not conducted due to large proportion of missing data|||Participants|||Count of Participants
2570049|NCT02533089|Secondary|Proportion of Default Cases (Treatment Interrupted >= 2 Consecutive Months)|secondary outcome =proportion of default cases (treatment interrupted >= 2 consecutive months)|1 year|analysis not conducted due to small proportion of default cases|||Participants|||Count of Participants
2570050|NCT02533089|Primary|Proportion of Cases Successfully Treated, Defined as the Total Number of Cases Cured and Completing Treatment.|primary outcome =proportion of cases successfully treated, defined as the total number of cases cured and completing treatment.|1 year||||Participants|||Count of Participants
2570051|NCT02533063|Secondary|Bioelectrical Impedance Spectroscopy (BIS)|An ImpediMed SFB7 device (Eight Mile Plains, Queensland, Australia) will be used to obtain these measurements. Participants will be positioned supine for a minimum of 10 minutes prior to acquisition; adequate separation of their legs will be obtained to allow for accurate BIS measurement. Measurements will be obtained by placing four EKG-like electrodes on the skin of the participant's hand, feet and knee. Wires will be attached from the BIS device to these skin electrodes. Painless electric waves will be sent through the tissues as noted above. Each measurement lasts only a few seconds. This method will generate measurements of lean mass.|Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.||||Mass (kg)||Standard Deviation|Mean
2570054|NCT02533063|Secondary|Timed-Up-and-Go (TUG)|The Timed-Up-and-Go (TUG) test will be performed twice; participants will be seated in an armless chair, upon instruction, they will be asked to stand, which starts the timing, they will walk 3 meters past a mark on the floor at their normal pace, turn around and return to a full seated position, at which time the test will end.|Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.|Not all participants completed the TUG testing.|||Time (seconds)||Standard Deviation|Mean
2570055|NCT02533063|Secondary|Short Physical Performance Battery (SPPB)|The short physical performance battery (SPPB) consists of gait speed as determined by a four-meter walk, timed repeated chair rise and standing balance. Gait speed will be measured by instructing participants to walk four meters at their normal pace; timed with a stopwatch and is repeated twice. The walk performed in the least time will be utilized for SPPB scoring purposes. The timed repeated chair rise has participants stand up from a chair five times without the use of their arms, if possible. Time to complete five stands is measured. Standing balance is assessed by having the participants stand in three positions of increasing difficulty for 10 seconds each. Standardized instructions will be given to all participants and the test performed twice. The SPPB will be conducted and scored in standard manner, score 0-12, with lower scores indicating mobility limitations. Participants will be wearing MobilityLabTM sensors to collect computerized data for these tests.|Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.|Not all participants completed the SPPB test.|||score on a scale||Standard Deviation|Mean
2570056|NCT02533063|Secondary|Sway|Sway is assessed by having the participants stand with feet being placed side by side for ten seconds. Participants will be wearing MobilityLabTM (APDM, Portland, OR) sensors on their chest, lower back, wrists and feet during these tests to collect computerized sway data.|Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.|Not all participants could complete the balance exercise and provide valid data for this measure.|||Area (cm square)||Standard Deviation|Mean
2570057|NCT02533063|Secondary|Gait Speed|Gait speed will be measured by instructing participants to walk four meters at their normal pace; they are timed with a stopwatch. This test will be repeated twice. The walk performed in the least time will be utilized for scoring purposes.|Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.||||Speed (m/sec)||Standard Deviation|Mean
2570058|NCT02533063|Secondary|Grip Strength|﻿Grip Strengthwas acquired using a JAMAR hand dynamometer in the routine clinical manner. Measurements were recorded using participants' non-dominant hand and repeated 3 times to determine maximum grip strength.|Measured at Baseline, after Intervention 1, after Washout, and after Intervention 2.||||Force (kg)||Standard Deviation|Mean
2570059|NCT02533063|Primary|Weight Corrected Jump Power Based on Participant's Jump on the Jump Force Plate|The primary aim of this pilot is to examine the effect of vibration therapy on muscle function. Weight corrected jump power will be the main outcome variable. Countermovement jumps are performed on a Leonardo force plate (Novotec Medical, Pforzheim, Germany) following standard procedures. Jumping mechanography uses maximal countermovement jumps to quantitatively measure muscle strength in the legs. Participants will be asked to perform three countermovement jumps. Participants are asked to try to jump as high as possible using both legs. Three jumps are performed; the jump with the highest jump height is used for analysis.|This was collected 4 times: Baseline, after 8 week loading/loading+ vibration training, after 4 week washout, after 8 week crossover training.|In this frail population a number of individuals were unable to perform satisfactory jumps to collect valid data with the current software.|||W/kg||Standard Deviation|Mean
2570060|NCT02532998|Secondary|Pharmacodynamics of AZD9977 by Assessment of Total Urine Volume Excreted Cumulatively and During Each of the Urine Collection Intervals|"Pharmacodynamics of AZD9977 by assessment of total urine volume excreted cumulatively and during each of the urine collection intervals.~Pharmacodynamics of AZD9977 after single dosing of AZD9977 with fludrocortisone and/or eplerenone"|From 8 hours before dosing until 24 hours after dosing|The PD analysis set will consist of all participants in the SAF with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who have no major protocol deviations thought to impact on the analysis of the PD data.|||mL||Standard Deviation|Mean
2570061|NCT02532998|Secondary|Pharmacodynamics of AZD9977 Assessed Per Urine Production for Each Urine Collection Time Interval.|"Pharmacodynamics of AZD9977 assessed per urine production for each urine collection time interval.~Pharmacodynamics of AZD9977 after single dosing of AZD9977 with fludrocortisone and/or eplerenone."|From 8 hours before dosing until 24 hours after dosing|The PD analysis set consisted of all participants in the SAF with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who had no major protocol deviations thought to impact on the analysis of the PD data.|||mL||Standard Deviation|Mean
2570062|NCT02532998|Secondary|Pharmacodynamics of AZD9977 by Assessment of Total Potassium Excreted Cumulatively and During Each of the Urine Collection Intervals|"Pharmacodynamics of AZD9977 by assessment of total potassium excreted cumulatively and during each of the urine collection intervals.~Pharmacodynamics of AZD9977 after single dosing of AZD9977 with fludrocortisone in comparison to AZD9977 placebo."|From 0 to 24 hours after dosing|The PD analysis set will consist of all participants in the SAF with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who have no major protocol deviations thought to impact on the analysis of the PD data.|||mmol||Standard Deviation|Mean
2570063|NCT02532998|Secondary|Pharmacodynamics of AZD9977 Assessed Per Fractional Potassium Excretion in Urine for Each Urine Collection Time Interval.|"Pharmacodynamics of AZD9977 assessed per fractional potassium excretion in urine for each urine collection time interval.~Pharmacodynamics of AZD9977 after single dosing of AZD9977 with fludrocortisone and/or eplerenone"|From 0 to 8 hours post dosing|The PD analysis set consisted of all participants in the SAF with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who had no major protocol deviations thought to impact on the analysis of the PD data.|||% value||Standard Deviation|Mean
2570072|NCT02532998|Secondary|Area Under Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2570064|NCT02532998|Secondary|Pharmacodynamics of AZD9977 Assessed Per Total Sodium Excreted Cumulatively and During Each of the Urine Collection Intervals.|"Pharmacodynamics of AZD9977 by assessment of total sodium excreted cumulatively and during each of the urine collection intervals.~Pharmacodynamics of AZD9977 after single dosing of AZD9977 with fludrocortisone and/or eplerenone."|From 0 to 24 hours after dosing|The PD analysis set consisted of all participants in the SAF with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who had no major protocol deviations thought to impact on the analysis of the PD data.|||mmol||Standard Deviation|Mean
2570065|NCT02532998|Secondary|Pharmacodynamics of AZD9977 Assessed by Estimating the Fractional Sodium Excretion in Urine for Each Urine Collection Time Interval.|"Pharmacodynamics of AZD9977 by assessment of fractional sodium excretion in urine for each urine collection time interval.~Pharmacodynamics of AZD9977 after single dosing of AZD9977 with fludrocortisone and/or eplerenone."|From 0 to 8 hours after dosing|The PD analysis set consisted of all participants in the SAF with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who had no major protocol deviations thought to impact on the analysis of the PD data.|||% value||Standard Deviation|Mean
2570066|NCT02532998|Secondary|Number of Participants With Clinically Significant Safety Laboratory Tests Values.|Clinically significant safety laboratory test values included hematology, clinical chemistry, urinalysis and urine chemistry, including urine creatinine and uric acid measurements. Viral serology and urine drugs of abuse, alcohol and cotinine were assessed for eligibility. If deterioration in laboratory value was associated with clinical symptoms and/or signs, the symptom or sign were reported as an adverse event and the associated laboratory result was considered as additional information. Laboratory results were listed and summarized according to change from baseline and repeat/unscheduled measurements. Any out of range laboratory results were flagged in the individual listings.|From screening to post-study visit, up to 10 weeks|The SAF included all participants who received at least one dose of any of the administered products (fludrocortisone, eplerenone or AZD9977/matching placebo) and for whom any safety data post-fludrocortisone dose were available.|||Participants|||Number
2570067|NCT02532998|Secondary|Number of Participants With Clinically Significant Physical Examination Values.|"Number of participants with clinically significant physical examination values.~The complete physical examinations included an assessment of the general appearance, respiratory, cardiovascular, abdomen, skin, head, and neck (including ears, eyes, nose, mouth and throat), lymph nodes, thyroid, musculoskeletal and neurological systems. The brief physical examinations included an assessment of the general appearance, skin, abdomen, cardiovascular and respiratory systems. The results of the physical examination were listed by body system for each subject. Body weight was listed by participant and time-point. Any new or aggravated clinically relevant abnormal medical finding at a physical examination as compared with the baseline assessment were reported as an adverse event (AE)."|From screening to post-study visit, up to 10 weeks|The SAF included all participants who received at least one dose of any of the administered products (fludrocortisone, eplerenone or AZD9977/matching placebo) and for whom any safety data post-fludrocortisone dose were available.|||Participants|||Number
2570068|NCT02532998|Secondary|Number of Participants With Clinically Significant Electrocardiogram.|"Clinically significant electrocardiogram values were recorded for all participants in the study.~A 12-lead ECG was obtained after each subject had rested in the supine position for at least 10 minutes and was performed in accordance with the Schedule of Assessments of study protocol.~The investigator judged the overall interpretation as normal or abnormal. If abnormal, it would have been decided as to whether or not the abnormality was clinically significant and the reason for the abnormality would have been recorded. The investigator could add extra 12-lead resting ECG safety assessments if there were any abnormal findings of if the investigator considered it was necessary for any other safety reason. These assessments would have been entered as an unscheduled assessment."|From screening to post-study visit, up to 10 weeks|The SAF included all participants who received at least one dose of any of the administered products (fludrocortisone, eplerenone or AZD9977/matching placebo) and for whom any safety data post-fludrocortisone dose were available.|||Participants|||Number
2570069|NCT02532998|Secondary|Number of Participants With Clinically Significant Pulse Rate.|"Clinically significant pulse rate (if available) was recorded for all participants in the study.~The pulse was obtained after each subject had rested in the supine position for at least 5 minutes and was performed in accordance with the Schedule of Assessments of study protocol.~Abnormal findings in pulse rate, after 10 minutes resting in the supine position, was defined as following:~• Pulse < 45 or > 85 beats per minute (bpm)"|From screening to post-study visit, up to 10 weeks|The SAF included all subjects who received at least one dose of any of the administered products (fludrocortisone, eplerenone or AZD9977/matching placebo) and for whom any safety data post-fludrocortisone dose were available.|||Participants|||Number
2570070|NCT02532998|Secondary|Number of Participants With Clinically Significant Blood Pressure Values.|"Clinically significant blood pressure values (if available) were recorded for all participants.~The systolic blood pressure (mmHg) and diastolic BP (mmHg) was obtained after each subject had rested in the supine position for at least 5 minutes and was performed in accordance with the Schedule of Assessments of study protocol.~Abnormal findings in blood pressure after 10 minutes resting in the supine position was defined as following:~Systolic blood pressure (SBP) < 90 mmHg or ≥ 140 mmHg~Diastolic blood pressure (DBP) < 50 mmHg or ≥ 90 mmHg."|From screening to post-study visit, up to 10 weeks|The safety analysis set (SAF) included all participants who received at least one dose of any of the administered products (fludrocortisone, eplerenone or AZD9977/matching placebo) and for whom any safety data post-fludrocortisone dose were available.|||Participants|||Number
2570071|NCT02532998|Secondary|Pharmacodynamics of AZD9977 Assessed Per Sodium/Potassium Ratio in Urine in AZD9977 Treatment With Placebo Versus Treatment With AZD9977.|"The sum over the urine collection intervals of the logarithm of the urinary sodium/potassium ratio from two hours to eight hours post-dose.~NOTE: Note: Data are presented as the sum of the difference between ln(Na+) and ln(K+) over the collected intervals 2-4, 4-6 and 6-8 hours."|From 2 hours post dose to 8 hours post dose|The pharmacodynamic (PD) analysis set consisted of all participants in the safety analysis set (SAF) with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who had no major protocol deviations thought to impact on the analysis of the PD data.|||sodium/potassium ratio||Standard Deviation|Mean
2570073|NCT02532998|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to t Hours After Dosing (AUC(0-t)) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2570074|NCT02532998|Secondary|Observed Maximum Concentration (Cmax) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2570075|NCT02532998|Secondary|Time to Reach Maximum Concentration (Tmax) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.|||h||Full Range|Median
2570076|NCT02532998|Secondary|Terminal Half-life (t½λz) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.|||h||Standard Deviation|Mean
2570077|NCT02532998|Secondary|Apparent Clearance (CL/F) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2570078|NCT02532998|Secondary|Apparent Volume of Distribution at Terminal Phase (Vz/F) of Eplerenone.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The eplerenone PK analysis set consisted of all participants who received at least one dose of eplerenone for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the eplerenone PK data.|||L||Geometric Coefficient of Variation|Geometric Mean
2570079|NCT02532998|Secondary|Apparent Volume of Distribution at Terminal Phase (Vz/F) of AZD9977.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all participants who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.|||L||Geometric Coefficient of Variation|Geometric Mean
2570080|NCT02532998|Secondary|Apparent Clearance (CL/F) of AZD9977.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all participants who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2570081|NCT02532998|Secondary|Terminal Half-life (t½λz) of AZD9977.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all participants who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.|||h||Standard Deviation|Mean
2570082|NCT02532998|Secondary|Time to Reach Maximum Concentration (Tmax) of AZD9977.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all subjects who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.|||h||Full Range|Median
2570083|NCT02532998|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to t Hours After Dosing (AUC[0-t]) of AZD9977.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all participants who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2570084|NCT02532998|Secondary|Area Under Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC) of AZD9977.|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all participants who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2570085|NCT02532998|Secondary|Observed Maximum Concentration (Cmax) of AZD9977|Pre IMP dose and post IMP dose at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours|From 2 hours post dose to 8 hours post dose|The AZD9977 PK analysis set consisted of all participants who received at least one dose of AZD9977 for whom at least one of the primary PK parameters was evaluable and who had no major protocol deviations thought to impact on the analysis of the AZD9977 PK data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2570120|NCT02532647|Secondary|Time to Start of Procedure|The time from the first administration of the study drug to the beginning of the colonoscopy|From the first administration of the study drug to the beginning of the colonoscopy|Patients who did not reach the endpoint are excluded from this analysis.|||minutes||Inter-Quartile Range|Median
2570086|NCT02532998|Primary|Pharmacodynamics of AZD9977 Assessed Per Sodium/Potassium Ratio in Urine in Eplerenone Treatment Versus a Combination Treatment of Eplerenone and AZD9977.|"The sum over the urine collection intervals of the logarithm of the urinary sodium/potassium ratio from two hours to eight hours post-dose.~NOTE: Data are presented as the sum of the difference between ln(Na+) and ln(K+) over the collected intervals 2-4, 4-6 and 6-8 hours."|From 2 hours post dose to 8 hours post dose|The pharmacodynamic (PD) analysis set consisted of all participants in the safety analysis set (SAF) with at least one evaluable sum of the logarithm of the sodium/potassium ratio from two hours up to eight hours post dose, and who had no major protocol deviations thought to impact on the analysis of the PD data.|||sodium/potassium ratio||Standard Deviation|Mean
2570087|NCT02532972|Secondary|Subjective Changes in Tinnitus Following Cochlear Implantation (THI)|"Tinnitus severity rated by the Tinnitus Handicap Index (THI). The THI score of 0-16 means no or slight handicap, 18 to 36 indicates mild, 38 to 56 indicates moderate, 58 to 76 indicates severe, and a score of 78-100 is classified as catastrophic handicap"|12 months post-operatively|11 participants had surgery, pre and postoperative 12 month time points have 5 participants with available THI data 1/11 - did not have THI data available preoperatively|||score on a scale||Full Range|Mean
2570088|NCT02532972|Primary|Speech Perception Following Cochlear Implantation Assessed by CNC Word Recognition Testing|Identification of stimuli from word and sentence lists, measured as a percent score of words recognized, measured at 65dB in Quiet.|12 months post-operatively|11 participants had surgery, but one subject opted out of additional follow-up after the 6 month visit one subject did not return for his one year followup visit following activation. As such,12 month time points only have 9 participants' data analyzed.|||percentage of words recognized||Full Range|Mean
2570089|NCT02532972|Primary|Sound Detection Via Pure-tone Threshold Audiometry (PTA)|Sound field thresholds following cochlear implantation via pure-tone threshold audiometry. Measured in dB where a lower number means more sensitive hearing and a higher number means less sensitive hearing.|12 months post-operatively|11 participants had surgery, but one subject opted out of additional follow-up after the 6 month visit one subject did not return for his one year followup visit following activation. As such,12 month time points only have 9 participants' data analyzed.|||dB||Full Range|Mean
2570090|NCT02532933|Primary|Patellar Flexion Measured as the Relative Angle Between the Femoral and Patellar Components of the Implant.|Difference between dome and anatomic patellofemoral flexion, which is measured as the relative angle between the femoral and patellar components of the implant.|One day||||degrees||Standard Deviation|Mean
2570091|NCT02532855|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at Week 0).|Baseline and Week 24|All randomized and treated participants who had at least one observation for the analysis endpoint, at baseline or subsequent to at least one dose of study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
2570092|NCT02532855|Secondary|Percentage of Participants With A1C <7% (53 mmol/Mol) at Week 24|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.|Week 24|All randomized and treated participants who had at least one observation for the analysis endpoint, at baseline or subsequent to at least one dose of study treatment.|||Percentage of Participants|||Number
2570093|NCT02532855|Secondary|Change From Baseline in Postprandial Insulin AUC0-120 Minutes to Glucagon AUC0-120 Minutes Ratio at Week 24|AUC endpoints were analyzed for participants who underwent the 3-point MMTT. Blood samples were drawn immediately prior to (T=0 minutes) and 60 and 120 minutes after the administration of the standard meal. The AUC curve was generated with the 3 time points. If any time point for a given participant was missing, the AUC was not included. The endpoint was calculated from the ratio of (insulin AUC / glucagon AUC) over the first 120 minutes following the morning meal at baseline minus AUC over the first 120 minutes following the morning meal at Week 24. A negative (-) change from baseline to Week 24 indicates better control of postprandial glucose.|Immediately before and 60 and 120 minutes after the standard meal at Baseline and Week 24|All randomized and treated participants who underwent MMTT for the analysis endpoint, had both baseline and Week 24 endpoint measurements, without: drug compliance <75%, use of prohibited AHA medications or pharmacologic doses of corticosteroids or incorrect double-blind study drug or a change in metformin or sulfonylurea dose.|||Ratio||95% Confidence Interval|Least Squares Mean
2570094|NCT02532855|Secondary|Change From Baseline in Insulin AUC0-120 Minutes at Week 24|AUC endpoints were analyzed for participants who underwent the 3-point MMTT. Blood samples were drawn immediately prior to (T=0 minutes) and 60 and 120 minutes after the administration of the standard meal. The AUC curve was generated with the 3 time points. If any time point for a given participant was missing, the AUC was not included. Change in Postprandial Insulin AUC after the morning meal (t=0 to 120 minutes) was calculated from insulin AUC over the first 120 minutes following the morning meal at baseline minus insulin AUC over the first 120 minutes following the morning meal at Week 24. A negative (-) change from baseline to Week 24 indicates better control of postprandial glucose.|Immediately before and 60 and 120 minutes after the standard meal at Baseline and Week 24|All randomized and treated participants who underwent MMTT for the analysis endpoint, had both baseline and Week 24 endpoint measurements, without: drug compliance <75%, use of prohibited AHA medications or pharmacologic doses of corticosteroids or incorrect double-blind study drug or a change in metformin or sulfonylurea dose.|||mIU.hr/L||95% Confidence Interval|Least Squares Mean
2570105|NCT02532764|Other Pre-specified|Adjusted Mean Change From Baseline in CFQ-R RSS as Compared to Placebo (Subgroup ppFEV1 <90% at Baseline)|"Patient Reported Outcome measure Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score (CFQ-R RSS).~A higher score represents a better outcome. A minimal clinically important difference (MCID) in the respiratory domain (CFQ-R RSS) has been established in stable populations as 4.0 points, and a maximum score is 100 points. Mean values reported refer to ''difference vs placebo in adjusted mean change from baseline'' values."|Day 15, Day 33, Day 54|All subjects treated with either QR-010 or placebo in the Multiple Ascending Dose cohorts that received at least 10 out of 12 doses, with ppFEV1 <90% at Baseline.|||score on a scale||Standard Error|Mean
2571694|NCT02513732|Secondary|Number of Participants With Death,Myocardial Infarction and Revascularization(DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|0 to 3 years|ITT population|||Participants|||Count of Participants
2570095|NCT02532855|Secondary|Change From Baseline in Glucagon Area Under the Curve (AUC0-120 Minutes) at Week 24|AUC endpoints were analyzed for participants who underwent the 3-point MMTT. Blood samples were drawn immediately prior to (T=0 minutes) and 60 and 120 minutes after the administration of the standard meal. The AUC curve was generated with the 3 time points. If any time point for a given participant was missing, the AUC was not included. Change in Postprandial Glucagon AUC after the morning meal (t=0 to 120 minutes) was calculated from the glucagon AUC over the first 120 minutes following the morning meal at baseline minus glucagon AUC over the first 120 minutes following the morning meal at Week 24. A negative (-) change from baseline to Week 24 indicates better control of postprandial glucose.|Immediately before and 60 and 120 minutes after the standard meal at Baseline and Week 24|All randomized and treated participants who underwent MMTT for the analysis endpoint, had both baseline and Week 24 endpoint measurements, without: drug compliance <75%, use of prohibited AHA medications or pharmacologic doses of corticosteroids or incorrect double-blind study drug or a change in metformin or sulfonylurea dose.|||pmol.hr/L||95% Confidence Interval|Least Squares Mean
2570096|NCT02532855|Secondary|Change From Baseline in 2-hr Postprandial Glucose (PPG) at Week 24|The 2hr PPG is the change from baseline in mean post prandial glucose (change from baseline PPG = Week 24 mean T-120 glucose minus Baseline mean T-120 glucose) and shows each drugs impact on PPG. The 2-point MMTT measured values at T-0 and T-120 while the 3-point MMTT measured values at T-0, T-60, and T-120: although only a subset of the study had the 3-point MMTT performed, all participants had a T-0 and T-120 time point. A negative (-) change from baseline to Week 24 indicates better control of postprandial glucose.|Immediately before and 120 minutes after the standard meal at Baseline and Week 24|All randomized and treated participants who underwent MMTT for the analysis endpoint, had both baseline and Week 24 endpoint measurements, without: drug compliance <75%, use of prohibited AHA medications or pharmacologic doses of corticosteroids or incorrect double-blind study drug or a change in metformin or sulfonylurea dose.|||mg/dL||95% Confidence Interval|Least Squares Mean
2570097|NCT02532855|Secondary|Change From Baseline in Incremental 2-hour (2-hr) Postprandial Glucose Excursion (PPGE) at Week 24|The 2hr PPGE is the change from baseline in the mean incremental change in post meal glucose defined as T-120 minus T-0 for each participant: change from baseline PPGE = Week 24 mean (T-120 minus T-0) minus Baseline mean (T-120 minus T-0). The 2-point MMTT measured values at T-0 and T-120 while the 3-point MMTT measured values at T-0, T-60, and T-120: although only a subset of the study had the 3-point MMTT performed, all participants had a T-0 and T-120 time point. A negative (-) change from baseline to Week 24 indicates better control of postprandial glucose.|Immediately before and 120 minutes after the standard meal at Baseline and Week 24|All randomized and treated participants who underwent MMTT for the analysis endpoint, had both baseline and Week 24 endpoint measurements, without: drug compliance <75%, use of prohibited AHA medications or pharmacologic doses of corticosteroids or incorrect double-blind study drug or a change in metformin or sulfonylurea dose.|||mg/dL||95% Confidence Interval|Least Squares Mean
2570098|NCT02532855|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product. The AE does not have to have a causal relationship with this treatment. The AE can include any unfavourable and unintended sign, symptom, or disease or any worsening (change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the pharmaceutical product.|Up to 24 weeks|All randomized and treated participants.|||Percentage of participants|||Number
2570099|NCT02532855|Primary|Percentage of Participants Who Experienced One or More Adverse Events|An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product. The AE does not have to have a causal relationship with this treatment. The AE can include any unfavourable and unintended sign, symptom, or disease or any worsening (change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the pharmaceutical product.|Up to 26 weeks|All randomized and treated participants.|||Percentage of participants|||Number
2570100|NCT02532855|Primary|Change From Baseline in A1C at Week 24|A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.|Baseline and Week 24|All randomized and treated participants who had at least one observation for the analysis endpoint, at baseline or subsequent to at least one dose of study treatment.|||Percent A1C||95% Confidence Interval|Least Squares Mean
2570101|NCT02532764|Other Pre-specified|Adjusted Mean Change From Baseline in ppFEV1 as Compared to Placebo (Subgroup ppFEV1 <90% at Baseline)|Exploratory efficacy parameter, as measured by spirometry, and expresssed in percent predicted FEV1. Mean values reported refer to ''difference vs placebo in adjusted mean change from baseline'' values.|Day 15, Day 33, Day 54|Subjects treated with either QR-010 or placebo in the Multiple Ascending Dose cohorts that received at least 10 out of 12 doses, with ppFEV1 <90% at Baseline.|||percentage of predicted||Standard Error|Mean
2570102|NCT02532764|Other Pre-specified|Adjusted Mean Change From Baseline in ppFEV1 (Subgroup ppFEV1 <90% at Baseline)|Exploratory efficacy parameter, as measured by spirometry, and expresssed in percent predicted FEV1. Mean values reported refer to ''adjusted mean change from baseline'' values.|Day 15, Day 33, Day 54|All subjects treated with either QR-010 or placebo in the Multiple Ascending Dose cohorts that received at least 10 out of 12 doses, with ppFEV1 <90% at Baseline..|||percentage of predicted||Standard Error|Mean
2570103|NCT02532764|Other Pre-specified|Adjusted Mean Change From Baseline in ppFEV1 as Compared to Placebo|Exploratory efficacy parameter, as measured by spirometry, and expresssed in percent predicted FEV1 (ppFEV1). Mean values reported refer to''difference vs placebo in adjusted mean change from baseline'' values.|Day 15, Day 33, Day 54|All subjects treated with either QR-010 or placebo in the Multiple Ascending Dose cohorts that received at least 10 out of 12 doses.|||percentage of predicted||Standard Error|Mean
2570104|NCT02532764|Other Pre-specified|Adjusted Mean Change From Baseline in ppFEV1|Exploratory efficacy parameter, as measured by spirometry, and expressed in percent predicted FEV1 (ppFEV1). Mean values reported refer to ''adjusted mean change from baseline'' values.|Day 15, Day 33, Day 54|All subjects treated with either QR-010 or placebo in the Multiple Ascending Dose cohorts that received at least 10 out of 12 doses.|||percentage of predicted||Standard Error|Mean
2570106|NCT02532764|Other Pre-specified|Adjusted Mean Change From Baseline in CFQ-R RSS (Subgroup ppFEV1 <90% at Baseline)|"Patient Reported Outcome measure Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score (CFQ-R RSS).~A higher score represents a better outcome. A minimal clinically important difference (MCID) in the respiratory domain (CFQ-R RSS) has been established in stable populations as 4.0 points, and a maximum score is 100 points. Mean values reported refer to ''adjusted mean change from baseline'' values."|Day 15, Day 33, Day 54|"Subjects treated with either QR-010 or placebo in the Multiple Ascending Dose cohorts that received at least 10 out of 12 doses, with ppFEV1 <90% at baseline.~For 1 subject in the placebo group no data were available at Day 54. Mean in this table refers to Adjusted Mean."|||score on a scale||Standard Error|Mean
2570107|NCT02532764|Other Pre-specified|Adjusted Mean Change From Baseline in CFQ-R RSS as Compared to Placebo|"Patient Reported Outcome measure Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score (CFQ-R RSS).~A higher score represents a better outcome. A minimal clinically important difference (MCID) in the respiratory domain (CFQ-R RSS) has been established in stable populations as 4.0 points, and a maximum score is 100 points. Mean values reported refer to ''adjusted mean change from baseline'' values."|Day 15, Day 33, Day 54|All subjects treated with either QR-010 or placebo in the Multiple Ascending Dose cohorts that received at least 10 out of 12 doses.|||score on a scale||Standard Error|Mean
2570108|NCT02532764|Other Pre-specified|Adjusted Mean Change From Baseline in CFQ-R RSS|Patient Reported Outcome measure Cystic Fibrosis Questionnaire-Revised Respiratory Symptom Score (CFQ-R RSS). A higher score represents a better outcome. A minimal clinically important difference (MCID) in the respiratory domain (CFQ-R RSS) has been established in stable populations as 4.0 points, and a maximum score is 100 points. Mean values reported refer to ''adjusted mean change from baseline'' values.|Day 15, Day 33, Day 54|"All subjects treated with either QR-010 or placebo in the Multiple Ascending Dose cohorts that received at least 10 out of 12 doses.~For 1 subject in the placebo group no data were available at Day 54. Mean in this table refers to Adjusted Mean."|||score on a scale||Standard Error|Mean
2570109|NCT02532764|Secondary|Serum Clearance (CL)|CL: Serum clearance will be estimated using the formula: CL = Dose/AUC0-∞.|8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts|The Serum Clearance is not reported because the %AUC extrapolation was too large.||||||
2570110|NCT02532764|Secondary|Area Under the Curve to Infinity [AUC(0-∞)]|AUC0-∞: Area under the curve to infinity will be calculated based on the last observed concentration Clast(obs) using formula: AUC0-∞=AUClast+Clast(obs)/λz|8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts|The Area Under the Curve to Infinity is not reported because the %AUC extrapolation was too large||||||
2570111|NCT02532764|Secondary|Area Under the Curve to Final Sample [AUC(0-last)]|Area under the curve to the final sample with a concentration greater than lower limit of quantification (LLQ) will be calculated using the linear trapezoidal method|8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts|Quantifiable serum concentrations are only available for the 50mg SAD and MAD cohort. For the PK parameters of the SAD 6.25, 12.5 and 25mg cohorts, no quantifiable serum concentrations could be measured. For the 6.25, 12.5 and 25mg MAD cohorts, no PK profiling was performed due to the large number of samples below the limit of detection.|||ng.hr/mL||Standard Deviation|Mean
2570112|NCT02532764|Secondary|Terminal Half-life (T1/2)|The terminal elimination half-life will be estimated by non-linear regression analysis of the terminal elimination slope|8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts|The terminal half-life is not reported because the %AUC (Area Under the Curve) extrapolation was too large.||||||
2570113|NCT02532764|Secondary|Time to Maximum Serum Concentration|Tmax: Time to Cmax of QR-010 serum concentrations.|8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts|Population included all subjects treated with either QR-010 or placebo. Quantifiable serum concentrations are only available for the 50mg SAD and MAD cohorts.|||hour||Full Range|Median
2570114|NCT02532764|Secondary|Maximum Serum Concentration|Cmax: QR-010 maximum serum concentrations|8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts|Study population included all subjects treated either with QR-010 or placebo. Quantifiable serum concentrations are only available for the 50mg SAD and 50 mg MAD cohorts.|||ng/mL||Standard Deviation|Mean
2570115|NCT02532764|Secondary|Number of Subjects With Abnormalities Reported Regarding Laboratory Parameters, Vital Signs, ECG, Spirometry, and Physical Findings.|Number of subjects experiencing at least one abnormality for the categories laboratory parameters, vital signs, ECG, spirometry and physical findings that were reported as treatment emergent adverse event with a relationship to study drug as either possibly, probably or definitely.|8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts|All subjects who received either QR-010 or placebo.|||Participants|||Count of Participants
2570116|NCT02532764|Primary|Incidence of Subjects Experiencing Dose-Limiting Toxicities (DLT) in Each Dose Cohort From Baseline Through End of Study Visit.|DLT's were defined as an allergic reaction, acute bronchospasm or acute AEs of interest requiring (immediate) medical intervention.|8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts|All subjects who received either QR-010 or placebo. There were no Dose Limiting Toxicities (DLTs) reported in the SAD or MAD cohorts.|||Participants|||Count of Participants
2570117|NCT02532764|Primary|Severity of Treatment Emergent Adverse Events From Baseline Through End of Study|"Assessment of severity of treatment emergent adverse events (TEAEs).~Severity is graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Modified for CF (CTCAE v4.03). For events not present in this listing the following grading was applied:~Mild: Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Moderate: Minimal, local, or noninvasive intervention indicated; discomfort sufficient to reduce or interfere with daily activities; Severe: Medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization may be indicated; disabling; limits self-care with significant interference with daily activities; incapacitating with inability to perform self care activities of daily living; Life-threatening: Urgent intervention indicated; immediate risk of death."|8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts|All subjects who received either QR-010 or placebo.|||Participants|||Count of Participants
2570118|NCT02532764|Primary|Incidence of Subjects Experiencing Treatment Emergent Adverse Events From Baseline Through End of Study|Number of subjects experiencing at least one treatment emergent adverse events (TEAEs)|8 Days for Single-dose cohorts; 8 weeks for Multiple-dose cohorts|All subjects who received either QR-010 or placebo|||Participants|||Count of Participants
2570121|NCT02532647|Primary|Success Rates of the Procedure|The success of the procedure, as measured by completion of the colonoscopy procedure, AND no requirement for a rescue sedative medication, AND no requirement of more than 5 doses of study medication within any 15 minute window. (For midazolam: 3 doses within any 12 minute window)|From first dose of study drug until the end of colonoscopy|All patients who were randomised, and analysed as randomised.|||Participants|||Count of Participants
2570122|NCT02532543|Secondary|Soft Tissue Dimensional Change at Month 6|The amount of soft tissue change will be assessed through the use of dental casts at two time points following extraction and ridge preservation at 6 months.|Month 6|Data for the Month 6 timepoint was not collected||||||
2570123|NCT02532543|Secondary|Mean Soft Tissue Dimensional Changes-Vertical|The amount of linear (mm) vertical soft tissue change at 3 months following tooth extraction at a position located mid-buccal, mid-palatal, mesial and distal of the extraction site. Data will be calculated using data from 3D scans of patient dental models using 3D software.|time of extraction to 3 months post extraction|One participant was lost to follow up.|||mm||Standard Deviation|Mean
2570124|NCT02532543|Secondary|Mean Soft Tissue Dimensional Changes-Horizontal|The amount of linear (mm) horizontal soft tissue change at 3 months following tooth extraction at a position located 2mm and 4mm vertically away from the height of the buccal bone plate. Data will be calculated using data from DICOM images acquired by CBCT and overlaid 3D scans of patient dental models using 3D software.|time of extraction to 3 months post extraction|One participant was lost to follow up. Measurements were taken at 2 and 4 mm instead of 3, 6 and 9 mm due to difficulties in data collection and patient variability|||mm||Standard Deviation|Mean
2570125|NCT02532543|Secondary|Total Mean Change in Soft Tissue Volume|The change in soft tissue volume at 3 months following tooth extraction will be assessed through the use of 3D scans of patient dental models at two time points following extraction and ridge preservation at 3 months.|time of extraction to 3 months post extraction|One participant was lost to follow up.|||mm^3||Standard Deviation|Mean
2570126|NCT02532543|Secondary|Mean Osseous Dimensional Changes-Vertical|The amount of linear (mm) vertical bone change at 3 months following tooth extraction at a position located mid-buccal, mid-palatal, mesial and distal of the extraction site. Data will be calculated using data from DICOM images acquired by CBCT using 3D software.|time of extraction to 3 months post extraction|One participant was lost to follow up.|||mm||Standard Deviation|Mean
2570127|NCT02532543|Secondary|Mean Osseous Dimensional Changes-Horizontal|The amount of linear (mm) horizontal bone change at 3 months following tooth extraction at a position located 2mm and 4mm vertically away from the height of the buccal plate. Data will be calculated using data from DICOM images acquired by CBCT using 3D software.|time of extraction to 3 months post extraction|One participant was lost to follow up. Measurements were taken at 2 and 4 mm instead of 3, 6 and 9 mm due to difficulties in data collection and patient variability|||mm||Standard Deviation|Mean
2570128|NCT02532543|Primary|Total Mean Change in Bone Volume|The change in bone volume at 3 months following extraction will be calculated using data from DICOM images acquired by Cone Beam Computed Tomography (CBCT) using 3D software|time of extraction to 3 months post extraction|One participant was lost to follow up.|||mm^3||Standard Deviation|Mean
2570129|NCT02532465|Secondary|Time to Achieve Best Fiberoptic View|After confirmation of adequate placement and ventilation, a flexible fiberoptic bronchoscope was inserted through the stem of the supraglottic device to visualize the glottic aperture. The time taken for bronchoscopy, defined as time from disconnection of the anesthetic circuit from the SGA to first visualization of the glottic aperture, was recorded.|15 seconds after insertion of Air-Q or i-gel||||seconds||Inter-Quartile Range|Median
2570130|NCT02532465|Secondary|Airway Insertion Time|Amount of time it takes to insert airway.|Immediately after anesthesia induction||||seconds||Inter-Quartile Range|Median
2570131|NCT02532465|Primary|Acceptable View of the Glottic Aperature (Grade I-II)|Grade I view - Glottic aperture seen completely without any obstruction, Grade II view - Glottic aperture seen only partially but visual obstruction is less than 50%.|15 seconds after insertion of Air-Q or i-gel||||participants|||Number
2570132|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 150 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"|||h*ng/mL||95% Confidence Interval|Least Squares Mean
2570133|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 80 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"|||h*ng/mL||95% Confidence Interval|Least Squares Mean
2570134|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of P3L 50 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"|||h*ng/mL||95% Confidence Interval|Least Squares Mean
2571695|NCT02513732|Secondary|Number of Participants With Death,Myocardial Infarction and Revascularization(DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|0 to 2 years|ITT population|||Participants|||Count of Participants
2570135|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to 10 Minutes After Start of Product Use (AUC0-10) of Nicotine Following Single Use of Nicorette® Inhalator|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, and 10 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"|||h*ng/mL||95% Confidence Interval|Least Squares Mean
2570136|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 150 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"|||h*ng/mL||95% Confidence Interval|Least Squares Mean
2570137|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 80 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"|||h*ng/mL||95% Confidence Interval|Least Squares Mean
2570138|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of P3L 50 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"|||h*ng/mL||95% Confidence Interval|Least Squares Mean
2570139|NCT02532374|Primary|Area Under the Concentration-time Curve From Start of Product Use to the Last Quantifiable Time Point (AUC0-last) of Nicotine Following Single Use of Nicorette® Inhalator|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"|||h*ng/mL||95% Confidence Interval|Least Squares Mean
2570140|NCT02532374|Primary|Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 150 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use)."|Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"|||minutes||Inter-Quartile Range|Median
2570141|NCT02532374|Primary|Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 80 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use)."|Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"|||minutes||Inter-Quartile Range|Median
2570142|NCT02532374|Primary|Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of P3L 50 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use)."|Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"|||minutes||Inter-Quartile Range|Median
2570143|NCT02532374|Primary|Time to the Maximum Concentration (Tmax) of Nicotine Following Single Use of Nicorette® Inhalator|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use)."|Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"|||minutes||Inter-Quartile Range|Median
2570199|NCT02531802|Secondary|Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults|Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).|19 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||fold change||95% Confidence Interval|Geometric Mean
2570144|NCT02532374|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 150 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 6 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 6: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"|||ng/mL||95% Confidence Interval|Least Squares Mean
2570145|NCT02532374|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 80 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 5 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 5: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit - 1 subject discontinued by the Principal Investigator = 14 subjects"|||ng/mL||95% Confidence Interval|Least Squares Mean
2570146|NCT02532374|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of P3L 50 µg/Puff|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 4 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 4: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"|||ng/mL||95% Confidence Interval|Least Squares Mean
2570147|NCT02532374|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of Nicorette® Inhalator|"T0 = start of product use.~Derived from multiple blood sampling pre- and post-product use on Visit 3 (over 240 minutes post-product use).~Geometric Least Squares (geometric LS) means are provided."|Visit 3: blood taken at 45, 30 and 15 minutes prior to T0 and 2, 4, 7, 10, 15, 20, 30, 40, 50, 60, 120, and 240 minutes after T0.|"PK population: all the subjects who have signed the informed consent, completed at least one P3L product use period and for whom at least one PK parameter can been derived.~=> 16 subjects - 1 subject withdrew after the product test at the admission visit =15 subjects"|||ng/mL||95% Confidence Interval|Least Squares Mean
2570148|NCT02532283|Secondary|Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms)|Percentage of participants with significant reduction in influenza symptom severity was defined as time from first dose of investigational product until first of 2 successive recordings in which FLU-PRO total score for each of 2 recordings <= to 1 and all FLU-PRO domain scores is <=1. FLU-PRO assesses 32 influenza symptoms in body areas (domains): Nose, throat, eyes, chest, gastrointestinal, body. Participants rate each symptom on a 5-point ordinal scale, with higher scores indicates more frequent symptom. For 27 of items, scale is as follows: 0 (Not at all), 1 (A little bit), 2 (Somewhat), 3 (Quite a bit), 4 (Very much). For 5 items, severity is assessed as numerical frequency i.e, vomiting or diarrhea (0-4 or more times); with frequency of sneezing, coughing, coughed up mucus or phlegm evaluated on a scale from 0 (Never)-4 (Always). FLU-PRO total score is computed as a mean score across all 32 items comprising instrument and ranges from 0 (symptom free) to 4 (very severe symptoms).|Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32 and 33|FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM and 'n' signifies number of participants evaluable at specified time points.|||Percentage of participants|||Number
2570149|NCT02532283|Secondary|Time to Significant Reduction in FLU-PRO Influenza Symptom Severity|Time to significant reduction in influenza symptom severity (mild/none) is time from first dose of investigational drug until first of 2 successive recordings in which total score for each of 2 recordings is lower or equal to 1 and all domain scores is lower or equal to 1. FLU-PRO assesses 32 influenza symptoms in body areas (domains): Nose, throat, eyes, chest, gastrointestinal, body. Participants rate each symptom on 5-point scale, with higher scores indicates more frequent symptom. For 27 of items, scale is as follows: 0 (Not at all), 1 (A little bit), 2 (Somewhat), 3 (Quite a bit), 4 (Very much). For 5 items, severity is assessed in terms of numerical frequency, i.e, vomiting/diarrhea (0 times, 1 time, 2 times, 3 times, or 4 or more times); with frequency of sneezing, coughing and coughed up mucus or phlegm evaluated on scale from 0=Never to 4=Always. FLU-PRO total score is computed as mean score across all 32 items and ranges from 0 (symptom free) to 4 (very severe symptoms).|Up to Day 33|FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.|||Hours||95% Confidence Interval|Median
2570150|NCT02532283|Secondary|Time to Return to Usual Health|Time to return to usual health was defined as the time in hours from the first dose of investigational product till the first one of 2 successive cases where the response is 'Yes' on FLU-PRO additional question 9 (Have you returned to your health today?).|Up to Day 33|FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.|||Hours||95% Confidence Interval|Median
2570151|NCT02532283|Secondary|Time to Hospital Discharge|Time to hospital discharge was calculated from the date of first study drug intake during hospitalization up to date of discharge.|Up to 28 Days|FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A.|||Days||95% Confidence Interval|Median
2570197|NCT02531802|Secondary|Geometric Mean Titer (GMT) of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose|Measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.|19 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||titer||95% Confidence Interval|Geometric Mean
2570152|NCT02532283|Secondary|Time to Return to Premorbid Functional Status|Time to return to premorbid functional status (time to return usual activities) was defined as time in hours from the first dose of investigational product till the first one of 2 successive cases where the response is 'Yes' on FLU-PRO additional question 7 (Have you returned to your usual activities today?).|Up to Day 33|FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.|||Hours||95% Confidence Interval|Median
2570153|NCT02532283|Secondary|Number of Participants With the Emergence of Drug Resistance Mutations With Oseltamivir (OST) and Pimodivir|Number of participants with emergence (from baseline) of drug resistance mutations detected by genotype or phenotype were reported.|Up to 28 Days|FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A.|||Participants|||Count of Participants
2570154|NCT02532283|Secondary|Percentage of Participants With Clinical Outcome Based on Ordinal Scale|The ordinal scale was used to assess participant's clinical outcome. It consists of 6 categories or clinical states that are exhaustive, mutually exclusive, and ordered, where 1- Death, 2- Admitted to intensive care unit (ICU) or mechanically ventilated/ extracorporeal membrane oxygenation (ECMO), 3- Non-ICU plus supplemental oxygen, 4- Non-ICU plus no supplemental oxygen, 5- Not hospitalized, but unable to continue activity, 6- Not hospitalized (NH) and continues activities.|Day 8|FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.|||Percentage of Participants|||Number
2570155|NCT02532283|Secondary|Time to Improvement of Respiratory Status|The time to improvement of respiratory status was defined as the time from first study treatment until the first assessment of a successive series of 3 recording where normalization of blood oxygen saturation and respiration rate occurred at respiration rate <=24 per minutes).|Up to 28 Days|FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.|||Hours||95% Confidence Interval|Median
2570156|NCT02532283|Secondary|Time to Improvement of Vital Signs|Time to improvement of vital signs was defined as the time from first study treatment to when at least 4 of 5 symptoms (temperature, blood oxygen saturation, heart rate, systolic blood pressure, and respiration rate) had recovered, including normalization of temperature and blood oxygen saturation. Resolution criteria for vital signs: for Temperature: oral temperature less than or equal to (<=) 36.5 degree Celsius (C) for elderly and <=37.2 C for adults; for oxygen saturation: greater than or equal to (>=) 92 percent (%) on room air without supplemental oxygen; for respiratory rate: <= 24 per minutes; for heart rate: <= 100 per minutes and for systolic blood pressure: >= 90 millimeters of mercury (mmHg).|Up to 28 Days|FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.|||Hours||95% Confidence Interval|Median
2570157|NCT02532283|Secondary|Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score|"FLU-PRO assesses 32 influenza symptoms in each of the following body areas (domains): Nose, Throat, Eyes, Chest/Respiratory, Gastrointestinal and Body/Systemic . Participants rate each symptom on a 5-point ordinal scale, with higher scores indicating a more frequent sign or symptom. For 27 of the items, the scale is as follows: 0 (Not at all), 1 (A little bit), 2 (Somewhat), 3 (Quite a bit), and 4 (Very much). For 5 items, severity is assessed in terms of numerical frequency, that is (i.e), vomiting or diarrhea (0 times, 1 time, 2 times, 3 times, or 4 or more times); with frequency of sneezing, coughing, and coughed up mucus or phlegm evaluated on a scale from 0 (Never) to 4 (Always).The FLU-PRO total score is computed as a mean score across all 32 items comprising the instrument. Total scores can range from 0 (symptom free) to 4 (very severe symptoms)."|Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, and 33|FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM and 'n' signifies number of participants evaluable at specified time points.|||Units on a scale||Standard Deviation|Mean
2570158|NCT02532283|Secondary|Percentage of Participants With Influenza Complications|Percentage of participants with following Influenza Complications: bacterial pneumonia (culture confirmed where possible), bacterial superinfections, respiratory failure, pulmonary disease (example, asthma, chronic obstructive pulmonary disease [COPD]), cardiovascular and cerebrovascular disease (example, myocardial infarction, congestive heart failure [CHF], arrhythmia, stroke) and all complications were reported.|Up to 28 Days|FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A.|||Percentage of participants|||Number
2570159|NCT02532283|Secondary|Area Under the Plasma Concentration-time Curve (AUC) of Viral Load|Viral load AUC was determined by qRT-PCR assay of nasal swabs. Viral Load LOQ = 2.18 log10 vp/mL, LOD = 2.05 log10 vp/mL. Results <LOQ and >LOD (target detected) are imputed with 2.12 log10 vp/mL. Results <LOD (target not detected) are imputed with 0 log10 vp/mL.|Baseline up to Day 8|FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A.|||Days*vp/mL||95% Confidence Interval|Mean
2570160|NCT02532283|Secondary|Rate of Decline in Viral Load|Rate of decline in viral load (Log10 viral particles per milliliter per day [log10 vp/mL/day]) during treatment was measured by qRT-PCR. Viral Load Limit of quantification (LOQ) = 2.18 log10 vp/mL, LOD = 2.05 log10 vp/mL. Results < LOQ and greater than > LOD (target detected) are imputed with 2.12 log10 vp/mL. Results <LOD (target not detected) are imputed with 0 log10 vp/mL.|Up to Day 7|FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A.|||Log10 vp/mL/day||95% Confidence Interval|Median
2570200|NCT02531802|Secondary|Geometric Mean Titer (GMT) for Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen, Among Adults|Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).|19 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||titer||95% Confidence Interval|Geometric Mean
2570161|NCT02532283|Secondary|Influenza Viral Load Over Time|Influenza viral load over time (Log 10 viral particles per milliliter [vp/mL]) was measured by qRT-PCR. Viral Load LOD = 2.18 log10 vp/mL. Results < LOQ and > LOD (target detected) are imputed with 2.12 log10 vp/mL and results <LOD (target not detected) are imputed with 0 log10 vp/mL.|Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14|FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM and 'n' signifies number of participants evaluable at specified time points.|||Log 10 vp/mL||Standard Deviation|Mean
2570162|NCT02532283|Secondary|Time to Influenza A Viral Negativity|Time to influenza A viral negativity was determined based on quantitative reverse transcription polymerase chain reaction (qRT-PCR). A participant was considered influenza A viral negative at the time point that the first negative nasal midturbinate (MT) swab was recorded (in days). Viral Load Limit of detection (LOD) = 2.18 log10 viral particles per milliliter (vp/mL). Results less than (<) limit of quantification (LOQ) and greater than (>) LOD (target detected) are imputed with 2.12 log10 vp/mL, results <LOD (target not detected) are imputed with 0 log10 vp/mL.|Up to 14 Days|Full Analysis set (FAS) was defined as all randomly assigned participants who received at least 1 dose of study drug and who had a confirmed infection with influenza A.|||Days||95% Confidence Interval|Median
2570163|NCT02532283|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious AEs (TESAEs)|An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with treatment and therefore can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with use of a medicinal product, whether or not related to that medicinal product. TEAEs were defined as AEs that were reported or worsened on after start of study drug(s) dosing through safety follow-up visit. A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulting in any of following outcomes: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.|Up to 28 Days|Safety analysis set included all participants who received at least one dose of study drug(s) and were analyzed by drug received.|||Participants|||Count of Participants
2570164|NCT02532283|Primary|Area Under the Plasma Concentration-time Curve From Time of Administration to 12 Hours After Dosing (AUC [0-12]) of Pimodivir|AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours after dosing of pimodivir. As per planned analysis, results are presented by age groups (65 to <= 85 years and 18 to <=64 years).|Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3|PK analysis set included all participants from whom sufficient concentration data were available to facilitate derivation of at least one PK parameter. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.|||nanogram hours per milliliter (ng*h/mL)||Standard Deviation|Mean
2570165|NCT02532283|Primary|Minimum Observed Plasma Concentration (Cmin) of Pimodivir|Cmin is the minimum observed plasma concentration. As per planned analysis, results are presented by age groups (65 to <= 85 years and 18 to <=64 years).|Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3|PK analysis set included all participants from whom sufficient concentration data were available to facilitate derivation of at least one PK parameter. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.|||ng/mL||Standard Deviation|Mean
2570166|NCT02532283|Primary|Maximum Observed Plasma Concentration (Cmax) of Pimodivir|Cmax is the maximum observed plasma concentration. As per planned analysis, results are presented by age groups (65 to less than or equal to [<=] 85 years and 18 to <=64 years).|Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3|Pharmacokinetic (PK) analysis set included all participants from whom sufficient concentration data were available to facilitate derivation of at least one PK parameter. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure (OM).|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2570167|NCT02532179|Secondary|Change in In-vitro Mouse Antigen Binding to B-cells|The plan was to analyze serum from cockroach subcutaneous immunotherapy (SCIT)-treated participants to determine if treatment inhibits in-vitro mouse antigen binding to B-cells after 6-months of treatment with mouse SCIT, using the per protocol allergenic extract doses. However, the Sponsor cancelled pursuit of mouse immunotherapy within its program at this time due to assay development complexities and cost; thus, there are no analyses/results for this endpoint/outcome.|Baseline (Pre-Treatment) to Week 24|No analysis conducted: Sponsor's decision to not pursue assay development in this study.||||||
2570168|NCT02532179|Secondary|Change in Mouse-Specific IgG4 Antibodies|"Serum Immunoglobulin G4 (IgG4) is a subtype of antibody produced by the immune system. If a participant has bacterial or viral infections, the immune system will respond to that particular infection by producing IgG4 antibodies.~This endpoint/outcome is the ratio of geometric means for baseline mouse-specific serum IgG4 versus post-baseline mouse-specific serum IgG4. The numerator is the geometric mean post-baseline IgG4 and, the denominator is the baseline IgG4. A ratio of greater than 1 would indicate an increase in IgG4 antibodies throughout the course of the study."|Baseline (Pre-Treatment) to Week 24|Intent-to-treat|||Ratio||95% Confidence Interval|Geometric Least Squares Mean
2570169|NCT02532179|Secondary|Change in Mouse-Specific IgG Antibodies|"Serum Immunoglobulin G (IgG) is an antibody produced by the immune system. If a participant has bacterial or viral infections, the immune system will respond to that particular infection by producing IgG antibodies.~This endpoint/outcome is the ratio of geometric means for baseline mouse-specific serum IgG versus post-baseline mouse-specific serum IgG. The numerator is the geometric mean post-baseline IgG and, the denominator is the baseline IgG. A ratio of greater than 1 would indicate an increase in IgG throughout the course of the study."|Baseline (Pre-Treatment) to Week 24|Intent-to-treat|||Ratio||95% Confidence Interval|Geometric Least Squares Mean
2570198|NCT02531802|Secondary|Number and Percentage of Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose|Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.|19 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||Participants|||Count of Participants
2570170|NCT02532179|Secondary|Change in Mouse-Specific IgE Antibodies|"Serum Immunoglobulin E (IgE) is an antibody produced by the immune system. If a participant has an allergy, the immune system will respond to that particular allergen by producing IgE antibodies. These antibodies travel to cells that release chemicals, causing allergic reactions.~This endpoint/outcome is the ratio of geometric means for baseline mouse-specific serum IgE versus post-baseline mouse-specific serum IgE. The numerator is the geometric mean post-baseline IgE and the denominator is baseline IgE. A ratio of greater than 1 would indicate an increase in IgE throughout the course of the study."|Baseline (Pre-Treatment) through Week 24|Intent-to-treat|||Ratio||95% Confidence Interval|Geometric Least Squares Mean
2570171|NCT02532179|Primary|Number of Reported Serious Adverse Events (SAEs)|Frequency of any Serious Adverse Events (SAEs) throughout the duration of study participation.|Baseline (Pre-Treatment) through 24 Weeks of Treatment|Intent-to-treat|||Number of SAEs|||Number
2570172|NCT02532179|Primary|Number of Reported Adverse Events (AEs)|Frequency of any AEs tabulated by preferred event term.|Baseline (Pre-Treatment) through 24 Weeks of Treatment|Intent-to-treat|||Events|||Number
2570173|NCT02532010|Secondary|Remission Duration|Time from CR documentation to AML relapse|time from complete remission to AML relapse, assessed throughout the study period up to 2 years.||||months||Full Range|Median
2570174|NCT02532010|Secondary|Time to Complete Response|Time from entry on study until documentation of complete remission (CR)|From entry on study until complete remission, assessed throughout the study period up to 2 years||||months||Full Range|Median
2570175|NCT02532010|Secondary|Event-free Survival|Time from entry on study until time at which there is treatment failure, AML relapse, or death from any cause|Time from entry on study until time at which there is treatment failure, AML relapse, or death from any cause, assessed throughout the study period up to 2 years||||months||Full Range|Median
2570176|NCT02532010|Secondary|Relapse-free Survival|Time from complete remission documentation to either AML relapse or death from any cause.|From date of complete remission until either AML relapse or death from any cause, whichever came first, assessed throughout the study period up to 2 years||||months||Full Range|Median
2570177|NCT02532010|Secondary|Overall Remission Rate|Overall remission rate is defined as number of subjects with complete remission (CR), Complete Remission with incomplete platelet recovery (CRp), Complete Remission with Incomplete Blood Count Recovery (CRi), Partial Remission (PR) according to the IWG criteria. CRi is defined as All CR criteria except for residual neutropenia (<1.0 x 109/L (1000/µL)) or thrombocytopenia (<100 x 109/L (100,000/µL)), PR is defined as relevant in the setting of phase I and II clinical trials only; all hematologic criteria of CR; decrease of bone marrow blast percentage to 5 to 25 percent; and decrease of pretreatment bone marrow blast percentage by at least 50 percent.|6 months||||Participants|||Count of Participants
2570178|NCT02532010|Secondary|Overall Survival|Survival following treatment to the date of death|2 years||||Participants|||Count of Participants
2570179|NCT02532010|Primary|Complete Remission Rate|Complete remission rate is defined as number of subjects with complete remission according to the IWG criteria, which is defined by presence of <5 percent of blasts in the bone marrow, absence of blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count >1.0 x 109/L (1000/µL); platelet count >100 x 109/L (100,000/µL); independence of red cell transfusions.|6 months||||Participants|||Count of Participants
2570180|NCT02531971|Primary|Area Under the Curve (AUC 0-∞ ) ng∙h/mL|drug concentration in serum vs. time; reflects the actual body exposure to drug after administration of a dose of the drug|10 procedure days for Duragesic and Mylan arms each|Reported values are for all 24 volunteers.|||ng∙h/mL||Standard Deviation|Mean
2570181|NCT02531867|Primary|Number of Participants With Adverse Events (AEs) Including Injection Site Reactions (ISRs) and Injection Associated Reactions (IARs)|Adverse events are any unwanted adverse medical occurrence in patients who are treated with a medicinal drug, whether or not considered drug-related. This includes events observed in patients administered with asfotase alfa between the first dose of asfotase alfa and the completion of patient's last visit for the clinical study.|Events that occurred between the first dose of asfotase alfa and the completion of the patient's last visit, which was up to 5 months.|All patients who met all of the inclusion and none of the exclusion criteria were defined as the enrolled population, which was also the analysis population.The safety set comprised all patients who received at least 1 dose of the investigational drug.|||Participants|||Count of Participants
2570182|NCT02531802|Secondary|Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 28, by Antigen|"Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|28 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||fold change||95% Confidence Interval|Geometric Mean
2570183|NCT02531802|Secondary|Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 28, by Antigen|"Fecal secretion was measured on Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|28 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||titer||95% Confidence Interval|Geometric Mean
2570184|NCT02531802|Secondary|Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen|"Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigens in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|28 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||Participants|||Count of Participants
2570806|NCT02524418|Secondary|Spybite Sampling Attempts Per Procedure|The mean number of attempts per procedure|Day 1|Of the 70 Cholangioscopy participants in the study only 44 participants had non-stone lithotripsy-related indications. Spyglass sampling was attempted in 36 procedures.|||sampling attempts per procedure|Number of procedures analyzed|Full Range|Mean
2570185|NCT02531802|Secondary|Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 28, by Antigen|"Fecal secretion was measured on Day 0 and Day 28 (2 weeks after administration of second dose of vaccine). Antigen in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|28 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||Participants|||Count of Participants
2570186|NCT02531802|Secondary|Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 19, by Antigen|"Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|19 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||fold change||95% Confidence Interval|Geometric Mean
2570187|NCT02531802|Secondary|Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 19, by Antigen|"Fecal secretion was measured on Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|19 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||titer||95% Confidence Interval|Geometric Mean
2570188|NCT02531802|Secondary|Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen|"Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigens in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|19 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||Participants|||Count of Participants
2570189|NCT02531802|Secondary|Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 19, by Antigen|"Fecal secretion was measured on Day 0 and Day 19 (5 days after administration of second dose of vaccine). Antigen in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|Day 19|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||Participants|||Count of Participants
2570190|NCT02531802|Secondary|Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects on Day 7, by Antigen|"Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigen in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|7 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||fold change||95% Confidence Interval|Geometric Mean
2570191|NCT02531802|Secondary|Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects on Day 7, by Antigen|"Fecal secretion was measured on Day 7 (7 days after administration of first dose of vaccine). Antigen in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|7 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||titer||95% Confidence Interval|Geometric Mean
2570192|NCT02531802|Secondary|Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen|"Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigens in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|7 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||Participants|||Count of Participants
2570193|NCT02531802|Secondary|Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response on Day 7, by Antigen|"Fecal secretion was measured on Day 0 and Day 7 (7 days after administration of first dose of vaccine). Antigens in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|7 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||Participants|||Count of Participants
2570194|NCT02531802|Secondary|Number of Antigen Responses in Plasma Immunoglobulin A (IgA) Experienced by Subjects||19 days|Participants with results for all antigens (CFA/I, CS3, CS5, CS6, LTB) tested for.|||Participants|||Count of Participants
2570195|NCT02531802|Secondary|Number of Antigen Responses in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Experienced by Subjects||19 days||||Participants|||Count of Participants
2570196|NCT02531802|Secondary|Geometric Mean Fold Change of Plasma Immunoglobulin G (IgG) Response to E. Coli Heat-labile Enterotoxin (LTB) After Either Vaccine Dose|Between baseline and after vaccination (measured 7 days after the first dose and 5 days after the second). B-subunit of the E. coli heat-labile enterotoxin (LTB) was one of the antigens in the ETVAX vaccine.|19 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||fold change||95% Confidence Interval|Geometric Mean
2570807|NCT02524418|Secondary|Strictures Found During the Procedure Will be Measured|The abnormalities found during the procedure, such as strictures.|Day 1|A total of 78 Cholangioscopic examinations were attempted|||strictures found|attempted Cholangioscopic exams||Number
2570201|NCT02531802|Secondary|Number and Percentage of Adult Subjects With ≥Two-fold and ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for O78 Antigen|Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second).|19 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||Participants|||Count of Participants
2570202|NCT02531802|Secondary|Geometric Mean Fold Change in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX|"Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|19 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||fold change||95% Confidence Interval|Geometric Mean
2570203|NCT02531802|Secondary|Geometric Mean Titer (GMT) of Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX|"Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|19 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||titer||95% Confidence Interval|Geometric Mean
2570204|NCT02531802|Secondary|Number and Percentage of Subjects With ≥Four-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX|"Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|19 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||Participants|||Count of Participants
2570205|NCT02531802|Secondary|Number and Percentage of Subjects With ≥Two-fold Increase in Plasma Immunoglobulin A (IgA) Response After Either Vaccine Dose, for Antigens in ETVAX|"Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|19 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||Participants|||Count of Participants
2570206|NCT02531802|Secondary|Geometric Mean Fold Change of Fecal Secretory Immunoglobulin A (SIgA) Response Among 6-11 Month Old Subjects, by Antigen|"Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is based on the maximum value for each subject. Antigen in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|28 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||fold change||95% Confidence Interval|Geometric Mean
2570207|NCT02531802|Secondary|Geometric Mean Titer (GMT) of Fecal Secretory Immunoglobulin A (SIgA) Response 6-11 Month Old Subjects, by Antigen|"Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is based on the maximum value for each subject. Antigen in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|28 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||titer||95% Confidence Interval|Geometric Mean
2570208|NCT02531802|Secondary|Number and Percentage of 6-11 Month Old Subjects With ≥Four-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen|"Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is subjects experiencing a four-fold rise at any of these time points. Antigens in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|28 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||Participants|||Count of Participants
2570209|NCT02531802|Secondary|Number and Percentage of 6-11 Month Old Subjects With ≥Two-fold Increase in Fecal Secretory Immunoglobulin A (SIgA) Response, by Antigen|"Fecal secretion was measured on Day 7, Day 19, and Day 28; number in table is subjects experiencing a two-fold rise at any of these time points. Antigen in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|28 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||Participants|||Count of Participants
2570210|NCT02531802|Secondary|Geometric Mean Fold Change of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen|"Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|19 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||fold change||95% Confidence Interval|Geometric Mean
2570211|NCT02531802|Secondary|Geometric Mean Titer (GMT) of Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen|"Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|19 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||titer||95% Confidence Interval|Geometric Mean
2570212|NCT02531802|Secondary|Number and Percentage of Subjects With ≥Four-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen|"Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|19 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||Participants|||Count of Participants
2570213|NCT02531802|Secondary|Number and Percentage of Subjects With ≥Two-fold Increase in Antibody Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response After Either Vaccine Dose, by Antigen|"Between baseline and post-immunization (measured 7 days after the first dose and 5 days after the second). Antigen in ETVAX were:~E. coli, CFA/I, strain ETEX 21 formalin inactivated, E. coli, CS3, strain ETEX 22 formalin inactivated, E. coli, CS5, strain ETEX 23 formalin inactivated, E. coli, CS6, strain ETEX 24 phenol inactivated, B-subunit of the E. coli heat-labile enterotoxin"|19 days|Subjects who received both vaccinations and had valid baseline and endline immunologic samples.|||Participants|||Count of Participants
2570214|NCT02531802|Primary|Number and Percentage of Participants Experiencing Unsolicited Adverse Events Related to Vaccine|Adverse events (AEs) were assessed post-vaccination using participant/parent/guardian interview (including memory aids), targeted physical examinations, vital signs and clinical laboratory tests and reactogenicity assessments which were completed following each vaccination. Unsolicited AEs were assessed through Day 42 and serious adverse events (SAEs) were assessed over the entire duration of the study.|6 months ± 14 days after the first dose||||Participants|||Count of Participants
2570215|NCT02531802|Primary|Number and Percentage of Participants Experiencing Solicited Events by Symptom and Maximum Severity|Adverse events (AEs) were assessed post-vaccination using participant/parent/guardian interview (including memory aids), targeted physical examinations, vital signs and clinical laboratory tests and reactogenicity assessments which were completed following each vaccination. The solicited AEs of nausea (adults only), abdominal pain/stomach ache (adults and children 24-59 months only), fever, vomiting and diarrhea were evaluated daily for 7 days post vaccination.|7 days after each vaccination (Day 7 and Day 21)||||Participants|||Count of Participants
2570216|NCT02531698|Secondary|Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains||Before Vaccination 1, 1 month after Vaccination 2, 1 month after Vaccination 3 and 6 months after Vaccination 3|Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation.|||titers||95% Confidence Interval|Geometric Mean
2570217|NCT02531698|Secondary|Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains||Before Vaccination 1, 1 month after Vaccination 2, 1 month after Vaccination 3 and 6 months after Vaccination 3|Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation.|||Percentage of participants||95% Confidence Interval|Number
2570218|NCT02531698|Secondary|Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2 and 6 Months After Vaccination 3|Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).|1 month after Vaccination 2 and 6 months after Vaccination 3|Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation.|||Percentage of participants||95% Confidence Interval|Number
2570219|NCT02531698|Secondary|Percentage of Participants Aged >=24 Months to <10 Years With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 3|Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).|1 month after Vaccination 3|Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation.|||Percentage of participants||95% Confidence Interval|Number
2570220|NCT02531698|Primary|Number of Days Participant's Missed School Due to Adverse Event (AE) During the Vaccination Phase||From the Vaccination 1 up to 1 month after the Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Days||Standard Deviation|Mean
2570221|NCT02531698|Primary|Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Vaccination 3|Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.|Within 30 minutes after Vaccination 3|"Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2570222|NCT02531698|Primary|Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Vaccination 2|Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.|Within 30 minutes after Vaccination 2|"Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2570223|NCT02531698|Primary|Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Vaccination 1|Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.|Within 30 minutes after Vaccination 1|Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).|||Percentage of participants||95% Confidence Interval|Number
2570224|NCT02531698|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|From the Vaccination 1 up to 1 month after the Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
2570225|NCT02531698|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Within 30 Days after any vaccination|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
2570226|NCT02531698|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Vaccination 3|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Within 30 Days after Vaccination 3|"Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2570227|NCT02531698|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Vaccination 2|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Within 30 Days after Vaccination 2|"Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2570228|NCT02531698|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Vaccination 1|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Within 30 Days after Vaccination 1|Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).|||Percentage of participants||95% Confidence Interval|Number
2570229|NCT02531698|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study|A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|From the Vaccination 1 up to 6 months after the Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants|||Number
2570230|NCT02531698|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-up Phase|A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|From 1 month after Vaccination 3 up to 6 months after the Vaccination 3|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) and had safety data available from after post third-vaccination blood draw to 6 months after last study vaccination.|||Percentage of participants|||Number
2570231|NCT02531698|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase|A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|From the Vaccination 1 up to 1 month after the Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants|||Number
2570232|NCT02531698|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination|A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|Within 30 Days after any vaccination|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants|||Number
2570233|NCT02531698|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 3|A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|Within 30 Days after Vaccination 3|Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit.|||Percentage of participants|||Number
2570234|NCT02531698|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 2|A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|Within 30 Days after Vaccination 2|Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit.|||Percentage of participants|||Number
2570235|NCT02531698|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 1|A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|Within 30 Days after Vaccination 1|Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).|||Percentage of participants|||Number
2570236|NCT02531698|Primary|Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Throughout the Study|A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.|From the Vaccination 1 up to 6 months after the Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
2570237|NCT02531698|Primary|Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) During the Follow-up Phase|A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.|From 1 month after Vaccination 3 up to 6 months after the Vaccination 3|"Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) and had safety data available from after post third-vaccination blood draw to 6 months after last study vaccination. Here N signifies number of participants who were evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2570238|NCT02531698|Primary|Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) During the Vaccination Phase|A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.|From the Vaccination 1 up to 1 month after the Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
2570239|NCT02531698|Primary|Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Any Vaccination|A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.|Within 30 Days after any vaccination|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
2570240|NCT02531698|Primary|Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 3|A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.|Within 30 Days after Vaccination 3|"Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2570241|NCT02531698|Primary|Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 2|A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.|Within 30 Days after Vaccination 2|"Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2570242|NCT02531698|Primary|Percentage of Participants With at Least 1 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 1|A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.|Within 30 Days after Vaccination 1|Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).|||Percentage of participants||95% Confidence Interval|Number
2570243|NCT02531698|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study|SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.|From Vaccination 1 up to 6 months after Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
2570244|NCT02531698|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase|SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.|From 1 month after Vaccination 3 up to 6 months after Vaccination 3|"Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) and had safety data available from after post third-vaccination blood draw to 6 months after last study vaccination. Here N signifies number of participants who were evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2570245|NCT02531698|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase|SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.|From the Vaccination 1 up to 1 month after Vaccination 3|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
2570246|NCT02531698|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination|SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.|Within 30 Days after any vaccination|Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
2570270|NCT02531633|Secondary|Part B: Change From Baseline in CRP Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B|Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36|ITT-Part B Population|||mg/L||Standard Deviation|Mean
2570247|NCT02531698|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 3|SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.|Within 30 Days after Vaccination 3|"Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2570248|NCT02531698|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 2|SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.|Within 30 Days after Vaccination 2|"Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2570249|NCT02531698|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 1|SAE was an adverse event (AE) resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.|Within 30 Days after Vaccination 1|Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).|||Percentage of participants||95% Confidence Interval|Number
2570250|NCT02531698|Primary|Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3|Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily activity).|Within 7 Days after Vaccination 3|"Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2570251|NCT02531698|Primary|Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2|Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily activity).|Within 7 Days after Vaccination 2|"Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2570252|NCT02531698|Primary|Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1|Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, >39.5 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily activity).|Within 7 Days after Vaccination 1|Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).|||Percentage of participants||95% Confidence Interval|Number
2570253|NCT02531698|Primary|Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3|Local reactions included pain at injection site, swelling and redness collected by using an e-diary. Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity) and severe (prevented daily activity). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).|Within 7 Days after Vaccination 3|"Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. Here N signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2570271|NCT02531633|Secondary|Part B: Change From Baseline in CRP Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B|Blood samples were collected for analysis of CRP. Data for Change from Baseline in serum CRP over time for part B was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40|ITT-Part B Population|||Milligram per liter (mg/L)||Standard Deviation|Mean
2570254|NCT02531698|Primary|Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2|Local reactions included pain at injection site, swelling and redness collected by using an e-diary. Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity) and severe (prevented daily activity). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).|Within 7 Days after Vaccination 2|"Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here number of participants analyzed (N) signifies number of participants evaluable for this outcome measure."|||Percentage of participants||95% Confidence Interval|Number
2570255|NCT02531698|Primary|Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1|Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity) and severe (prevented daily activity). Redness and swelling were graded as: mild (0.5-2.0 centimeter [cm]), moderate (2.5 to 7.0 cm) and severe (>7.0 cm).|Within 7 Days after Vaccination 1|Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).|||Percentage of participants||95% Confidence Interval|Number
2570256|NCT02531698|Primary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3|Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 percent (%) confidence interval (CIs). LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).|1 month after Vaccination 3|Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation.|||Percentage of participants||95% Confidence Interval|Number
2570257|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DT Investigational Phantom Images|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|77 phantom image ratings from 7 radiologist readers (11 images rated x 7 readers) for Predicate & Invest. DT - Phantom Images arm above.|||units on a scale|images|Standard Error|Mean
2570258|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - LT Predicate Phantom Images|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|77 phantom image ratings from 7 radiologist readers (11 images rated x 7 readers) for Predicate & Invest. DT - Phantom Images arm above.|||units on a scale|images|Standard Error|Mean
2570259|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DT Investigational - Scout & DT Volume|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 month|119 image ratings from 7 radiologist readers (17 images rated x 7 readers) for DT Investigational - Scout & DT Volume.|||units on a scale|images|Standard Error|Mean
2570260|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DT Reference 2 - PA and LAT Chest|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|119 image ratings from 7 radiologist readers (17 images rated x 7 readers) for Predicate & Invest. DT Reference 2 - PA and LAT Chest arm above.|||units on a scale|images|Standard Error|Mean
2570261|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DT Reference 1- PA Chest|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|119 image ratings from 7 radiologist readers (17 images rated x 7 readers) for Predicate & Invest. DT Reference 1 - PA Chest arm above.|||units on a scale|images|Standard Error|Mean
2570262|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DE Investigational Low Energy|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months||||units on a scale|images|Standard Error|Mean
2570263|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DE Investigational High Energy|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months||||units on a scale|images|Standard Error|Mean
2570264|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DE Investigational Composite|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months||||units on a scale|images|Standard Error|Mean
2570265|NCT02531646|Primary|Radlex Scale for Diagnostic Quality Ratings - DE Predicate PA Chest|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|3 months|224 image ratings from 7 radiologist readers (32 images rated x 7 readers) for Predicate & Invest. DE - Human Subjects arm above.|||units on a scale|images|Standard Error|Mean
2570266|NCT02531633|Secondary|Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B|EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 100 (Best imaginable health state) and 0 (Worst imaginable health state). Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Day 0) and Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169, 344 and 373 and Week 12|ITT-Part B Population|||Scores on scale|||Number
2570267|NCT02531633|Secondary|Part B: Change From Baseline in EQ-5D-5L VAS Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B|EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 6 dimensions: 1.Mobility, 2.Self, 3.Usual Activities, 4.Pain/Discomfort, 5.Anxiety/Depression; 6.How good or or bad your health is today. Each of these 6 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 'Best imaginable health state' and 'Worst imaginable health state'. Answers to 'How good or bad your health is today' were measured on a 100 point VAS scale. Baseline for Part B is the last non-missing measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Day 0) and Days 85, 87, 91, 113, 162, 339 and 344 and Weeks 12 and 24|ITT-Part B Population|||Scores on scale|||Number
2570268|NCT02531633|Secondary|Part B: Change From Baseline in ESR Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B|Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Day 0), Weeks 4, 8, 12, 16, 24 and 36|Safety-Part B Population|||mm/h||Standard Deviation|Mean
2570269|NCT02531633|Secondary|Part B: Change From Baseline in ESR Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B|Blood samples were collected for analysis of ESR. Data for Change from Baseline in ESR over time for part A was reported. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40|Safety-Part B Population|||Millimeter per hour (mm/h)||Standard Deviation|Mean
2570321|NCT02531633|Secondary|Part A: Change From Baseline in Free and Total Interleukin-6 (IL-6) Over Time|Blood samples for Pharmacodynamic analysis were planned but not collected due to early termination of study.|Baseline (Week 0) and up to 52 weeks|Safety Population. Data was not collected due to early termination of the study||||||
2570272|NCT02531633|Secondary|Part B: Number of Participants With PGIC Score Over Time Who Never Received 100 mg OL Sirukumab in Part B|Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.|Baseline (Day 1)|ITT-Part B Population|||Participants|||Number
2570273|NCT02531633|Secondary|Part B: Number of Participants With PGIC Score Over Time Who Received at Least One Dose of 100 mg OL Sirukumab in Part B|Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.|Baseline (Day 1), Days 103 and 271|ITT-Part B Population|||Participants|||Number
2570274|NCT02531633|Secondary|Part B: Change From Baseline in PhGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B|"In PhGA was based on What is physician's assessment of the participant's current disease activity. PhGA used a 10 cm VAS ranging from 0 (none) to 10 (extremely active). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported."|Baseline (Day 0), Weeks 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85, 112, 113, 163, 169 and 373|ITT-Part B Population. Only those participants with data available at the specified time points were analyzed.|||Scores on scale|||Number
2570275|NCT02531633|Secondary|Part B: Change From Baseline in PhGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B|"In PhGA was based on What is physician's assessment of the participant's current disease activity. PhGA used a 10 cm VAS ranging from 0 (none) to 10 (extremely active). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value."|Baseline (Day 0) and Day 85, Day 113, Day 162, Day 203, Day 339, Day 344, Week 2, Week 4, Week 8, Week 12, Week 14, Week 16, Week 24, Week 36, Week 38, Week 40|ITT-Part B Population|||Scores on scale|||Number
2570276|NCT02531633|Secondary|Part B: Change From Baseline in PtGA Score for Participants Who Never Received 100 mg OL Sirukumab in Part B|"The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 (very well) to 10 (very poor). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported."|Baseline (Day 0), Weeks 2, 4, 8, 12, 16, 36; Days 23, 29, 30, 57, 59, 64, 65, 85,112, 113, 115, 163, 169 and 373|ITT-Part B Population|||Scores on scale|||Number
2570277|NCT02531633|Secondary|Part B: Change From Baseline in PtGA Score for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B|"The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS). of 10 centimeter (cm) ranging from 0 (very well) to 10 (very poor). Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value."|Baseline (Day 0), Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38, 40; Days 85, 87, 91, , 113, 162, 339, and 344|ITT-Part B Population|||Scores on scale|||Number
2570278|NCT02531633|Secondary|Part B: HAQDI Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B|"Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing no difficulty (0), some difficulty (1), much difficulty (2), and unable to do (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability"|Day 29, 64, 65, 85, 112, 113, 169, 373 and Week 12|ITT-Part B Population|||Scores on scale|||Number
2570279|NCT02531633|Secondary|Part B: HAQDI Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B|"Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing no difficulty (0), some difficulty (1), much difficulty (2), and unable to do (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability"|Day 87, 339, 344, Week 12, 24|ITT-Part B Population|||Scores on scale|||Number
2570280|NCT02531633|Secondary|Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Never Received at Least One Dose of 100mg OL Sirukumab in Part B|"The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, no pain to 10, the worst pain imaginable. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported."|Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24|ITT-Part B Population|||Scores on scale|||Number
2570281|NCT02531633|Secondary|Part B: Change From Baseline in Pain NRS Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B|"The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain now on an 11-point numeric rating scale ranging from 0, no pain to 10, the worst pain imaginable. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value."|Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24|ITT-Part B Population|||Scores on scale|||Number
2570282|NCT02531633|Secondary|Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B|The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Participants with post baseline data were reported.|Baseline (Day 0) and Day 85,87,91,113,162 344,339,Week 12, 24|ITT-Part B Population|||Scores on scale|||Number
2570283|NCT02531633|Secondary|Part B: Change From Baseline in FACIT-Fatigue Scores Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B|The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Day 0) and Day 85,87,91,113,162, 344,339,Week 12, 24|ITT-Part B Population|||Scores on scale|||Number
2570284|NCT02531633|Secondary|Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Never Received 100mg OL Sirukumab in Part B|EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Day 0) and Day 29, 30, 57, 59, 64, 65, 85, 112, 113,163,169 and 373, Week 12|ITT-Part B Population|||Scores on scale|||Number
2570285|NCT02531633|Secondary|Part B: Change From Baseline in EQ-5D-5L Index Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B|EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score). Baseline was last measurement done up to and including Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Day 0) and Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week24|ITT-Part B Population|||Scores on scale|||Number
2570286|NCT02531633|Secondary|Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Never Received 100 mg OL Sirukumab in Part B|SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who never received 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Day 0) and Day 23, Day 29, Day 30, Day 57, Day 59, Day 64, Day 65 , Day 85, Day 112, Day 113, Day 163, Day 169, Day 373, Week 8 and Week 12|ITT-Part B Population|||Scores on scale|||Number
2570322|NCT02531633|Secondary|Part A: Mean Serum Anti-sirukumab Antibodies|Blood samples for Pharmacokinetic analysis of Serum anti-sirukumab antibodies were planned to be collected at specified time points.|Baseline (Week 0) and up to 52 weeks|Safety Population. Data was not collected due to early termination of the study||||||
2570323|NCT02531633|Secondary|Part A: Mean Serum Concentrations of Sirukumab|Blood samples for Pharmacokinetic analysis of sirukumab serum concentrations were planned to be collected at specified time points.|Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 44 and 52|Safety Population. Data was not collected due to early termination of the study||||||
2570287|NCT02531633|Secondary|Part B: Change From Baseline in 36-item SF-36 v2 Acute Score Over Time for Participants Who Received at Least One Dose of 100 mg OL Sirukumab in Part B|SF-36v2 acute health survey questionnaire was developed as part of the Rand Health Insurance Experiment and consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for participants (Par) who received at least one dose of 100 mg OL Sirukumab has been presented. Baseline was the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Day 0), Day 85, Day 87, Day 91, Day 113, Day 162, Day 339, Day 344, Week 12 and Week 24|ITT-Part B Population|||Scores on scale|||Number
2570288|NCT02531633|Secondary|Part B: Number of Hospitalizations for Disease Flare Over Time|"Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: Severe Flare including Hospitalizations. Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study."|Up to Week 104|ITT-Part B Population.|||Number of hospitalizations|||Number
2570289|NCT02531633|Secondary|Part B: Number of Participants Requiring at Least One Hospitalization for Disease Flare|"Number of participants with at least one flare at a given visit was the number of participants with at least one flare between first SC IP intake and the day of the given visit. The hospitalizations for disease flare were planned to be identified through the adjudication of adverse events of special interest, and include events from the category: Severe Flare including Hospitalizations. Data for participants requiring hospitalizations for disease flare for part B was not available due to early termination of study."|Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40|ITT-Part B Population.|||Participants|||Count of Participants
2570290|NCT02531633|Secondary|Part B: Number of Disease Flares Over Time|This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants. Data for number of disease flares per participant over time for part B were presented.|Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40|ITT-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Disease flares|||Number
2570291|NCT02531633|Secondary|Part B: Cumulative Prednisone Dose Over Time for Participants Who Never Received 100 mg Open Label Sirukumab in Part B|Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who never received 100 mg open label Sirukumab has been presented.|Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38|ITT-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Milligrams||Standard Deviation|Mean
2570292|NCT02531633|Secondary|Part B: Cumulative Prednisone Dose Over Time for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B|Cumulative prednisone dose is the cumulative doses taken from start of Part B. The cumulative prednisone dose at each visit was calculated based on the number of participants who attended that visit. Data for participants who received at least one dose of 100mg open label Sirukumab was presented.|Weeks 2, 4, 8, 12, 14, 16, 24, 28, 32 and 38|ITT-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Milligrams||Standard Deviation|Mean
2570293|NCT02531633|Secondary|Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B|Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.|Baseline (Week 0) and Weeks 4,8,12,16,24 and 36|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2570294|NCT02531633|Secondary|Part B: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B|Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2570295|NCT02531633|Secondary|Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Never Received 100 mg Open Label Sirukumab in Part B|Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented|Baseline (Week 0) and Weeks 4,8,12,16,24 and 36|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||International units per liter||Standard Deviation|Mean
2570296|NCT02531633|Secondary|Part B: Change From Baseline in Clinical Chemistry Parameters: ALT, ALP and AST for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B|Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||International units per liter||Standard Deviation|Mean
2570297|NCT02531633|Secondary|Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Never Received 100 mg Open Label Sirukumab in Part B|Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.|Baseline (Week 0) and Weeks 4,8,12,16,24 and 36|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2570298|NCT02531633|Secondary|Part B: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B|Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2570299|NCT02531633|Secondary|Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Never Received 100 mg Open Label Sirukumab in Part B|Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.|Baseline (Week 0) and Weeks 4,8,12,16,24 and 36|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2570300|NCT02531633|Secondary|Part B: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B|Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2570301|NCT02531633|Secondary|Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Never Received 100 mg Open Label Sirukumab in Part B|Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.|Baseline (Week 0) and Weeks 4,8,12,16,24 and 36|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Trillion cells per liter||Standard Deviation|Mean
2570302|NCT02531633|Secondary|Part B: Change From Baseline in Hematology Parameter- Erythrocytes for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B|Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Trillion cells per liter||Standard Deviation|Mean
2570303|NCT02531633|Secondary|Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B|Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.|Baseline (Week 0) and Weeks 4,8,12,16,24 and 36|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Picograms||Standard Deviation|Mean
2570334|NCT02531633|Secondary|Part A: Change From Baseline in Temperature|Temperature was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)|||Celsius||Standard Deviation|Mean
2570304|NCT02531633|Secondary|Part B: Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B|Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL Sirukumab is presented.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Picograms||Standard Deviation|Mean
2570305|NCT02531633|Secondary|Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Never Received 100 mg Open Label Sirukumab in Part B|Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.|Baseline (Week 0) and Weeks 4,8,12,16,24 and 36|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Femtoliter||Standard Deviation|Mean
2570306|NCT02531633|Secondary|Part B: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B|Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Femtoliter||Standard Deviation|Mean
2570307|NCT02531633|Secondary|Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Never Received 100 mg Open Label Sirukumab in Part B|Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.|Baseline (Week 0) and Weeks 4,8,12,16,24 and 36|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Proportion of red blood cells in blood||Standard Deviation|Mean
2570308|NCT02531633|Secondary|Part B: Change From Baseline in Hematology Parameter-Hematocrit for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B|Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Proportion of red blood cells in blood||Standard Deviation|Mean
2570309|NCT02531633|Secondary|Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Never Received 100 mg Open Label Sirukumab in Part B|Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.|Baseline (Week 0) and Weeks 4,8,12,16,24 and 36|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2570310|NCT02531633|Secondary|Part B: Change From Baseline in Hematology Parameters- MCHC and Hemoglobin for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B|Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2570311|NCT02531633|Secondary|Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Never Received 100 mg Open Label Sirukumab in Part B|Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.|Baseline (Week 0) and Weeks 4,8,12,16,24 and 36|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Giga cells per liter||Standard Deviation|Mean
2570335|NCT02531633|Secondary|Part A: Change From Baseline in Pulse Rate|Pulse rate was measured in semi-supine position after 5 minutes rest at Baseline and up to 52 weeks. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)|||Beats per minute||Standard Deviation|Mean
2570312|NCT02531633|Secondary|Part B: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B|Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters.Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 14, 16, 24, 36, 38 and 40|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Giga cells per liter||Standard Deviation|Mean
2570313|NCT02531633|Secondary|Part B: Change From Baseline in Temperature for Participants Who Never Received 100 mg Open Label Sirukumab in Part B|Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.|Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Celsius||Standard Deviation|Mean
2570314|NCT02531633|Secondary|Part B: Change From Baseline in Temperature for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B|Temperature was measured in semi-supine position after 5 minutes rest.. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.|Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Celsius||Standard Deviation|Mean
2570315|NCT02531633|Secondary|Part B: Change From Baseline in Pulse Rate for Participants Who Never Received 100 mg Open Label Sirukumab in Part B|Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab is presented.|Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||beats per minute||Standard Deviation|Mean
2570316|NCT02531633|Secondary|Part B: Change From Baseline in Pulse Rate for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B|Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.|Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||beats per minute||Standard Deviation|Mean
2570317|NCT02531633|Secondary|Part B: Change From Baseline in SBP and DBP for Participants Who Never Received 100 mg Open Label Sirukumab in Part B|SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who never received 100 mg open label Sirukumab has been presented.|Baseline (Week 0) and Weeks 4,8,12,16,24,36 and follow up (Week 120)|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Millimeters of mercury||Standard Deviation|Mean
2570318|NCT02531633|Secondary|Part B: Change From Baseline in SBP and DBP for Participants Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B|SBP and DBP were measured in semi-supine position after 5 minutes rest for the participant. Baseline was defined as the last measurement done up to and including the Week 52 visit date of Part A. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for participants who received at least one dose of 100 mg OL sirukumab is presented.|Baseline (Week 0) and Weeks 2,4,8,12,14,16,24,36,38,40 and follow up (Week 120)|Safety-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Millimeters of mercury||Standard Deviation|Mean
2570319|NCT02531633|Secondary|Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Never Received 100mg OL Sirukumab in Part B|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs for part B have been reported.|Up to 120 weeks|Safety-Part B Population|||Participants|||Count of Participants
2570320|NCT02531633|Secondary|Part B: Number of Participants With AEs, SAEs and Corticosteroid Related AEs Who Received at Least One Dose of 100 mg Open-label Sirukumab in Part B|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs for part B have been reported.|Up to 120 weeks|Safety-Part B Population included all randomized participants who received at least 1 dose of SC IP in Part A and entered Part B|||Participants|||Count of Participants
2570324|NCT02531633|Secondary|Part A: Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Indirect Bilirubin|Blood samples were collected to analyze the chemistry parameters including bilirubin, creatinine, direct bilirubin and indirect bilirubin. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Micromoles per liter||Standard Deviation|Mean
2570325|NCT02531633|Secondary|Part A: Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST)|Blood samples were collected to analyze the chemistry parameters including ALT,ALP and AST. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||International units per liter||Standard Deviation|Mean
2570326|NCT02531633|Secondary|Part A: Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein|Blood samples were collected to analyze the chemistry parameters including Albumin and Protein. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Grams per liter||Standard Deviation|Mean
2570327|NCT02531633|Secondary|Part A: Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea|Blood samples were collected to analyze the chemistry parameters including Calcium, Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea . Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Millimoles per liter||Standard Deviation|Mean
2570328|NCT02531633|Secondary|Part A:Change From Baseline in Hematology Parameter- Erythrocytes|Blood samples were collected to analyze the hematology parameter Erythrocytes. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||trillion cells per liter||Standard Deviation|Mean
2570329|NCT02531633|Secondary|Part A:Change From Baseline in Hematology Parameter-Erythrocytes Mean Corpuscular Hemoglobin|Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Hemoglobin. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Picograms||Standard Deviation|Mean
2570330|NCT02531633|Secondary|Part A: Change From Baseline in Hematology Parameter -Erythrocytes Mean Corpuscular Volume|Blood samples were collected to analyze the hematology parameter Erythrocytes Mean Corpuscular Volume. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)|||Femtoliter||Standard Deviation|Mean
2570331|NCT02531633|Secondary|Part A: Change From Baseline in Hematology Parameter-Hematocrit|Blood samples were collected to analyze the hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)|||Proportion of red blood cells in blood||Standard Deviation|Mean
2570332|NCT02531633|Secondary|Part A: Change From Baseline in Hematology Parameters- Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin|Blood samples were collected to analyze the hematology parameters including MCHC and Hemoglobin. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)|||Grams per liter||Standard Deviation|Mean
2570333|NCT02531633|Secondary|Part A: Change From Baseline in Hematology Parameters- Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets|Blood samples were collected to analyze the hematology parameters including Eosinophils, Leukocytes, Lymphocytes, Neutrophils and Platelets. Change from Baseline is presented for these parameters. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Week 0) and Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)|||Giga cells per liter||Standard Deviation|Mean
2570808|NCT02524418|Secondary|Number of Cholangioscopic Exams That Detected Ductal Stones|The abnormalities found during the procedure, such as ductal stones.|Day 1|There were a total of 78 Cholangioscopic examinations in the 70 subjects in this study; 35 exam found stones. Where as in the Pancreatoscopy arm 5 participants were evaluated with only 3 exams being evaluable..|||exams|total number of exams||Number
2570336|NCT02531633|Secondary|Part A: Change From Baseline in : Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured in semi-supine position after 5 minutes rest at indicated time points. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value.|Baseline (Week 0), Weeks 2, 4 ,8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Safety Population Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles)..|||Millimeters of mercury||Standard Deviation|Mean
2570337|NCT02531633|Secondary|Part A: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and Corticosteroid Related AEs|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Number of participants with AEs, SAEs and corticosteroid related AEs have been reported.|Up to 52 weeks|Safety Population.|||Participants|||Count of Participants
2570338|NCT02531633|Secondary|Part A: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time|Blood samples were collected for analysis of ESR. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in ESR over time for part A was reported.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Millimeters per hour||Standard Deviation|Mean
2570339|NCT02531633|Secondary|Part A: Change From Baseline in Serum C Reactive Protein (CRP) Over Time|Blood samples were collected for analysis of CRP. Baseline was defined as the last non-missing value before first SC IP intake. Change from Baseline was defined as post-Baseline value minus Baseline value. Data for Change from Baseline in serum CRP over time for part A was reported. The Safety set comprised of all randomized participants who received at least 1 dose of SC IP.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Milligrams per liter||Standard Deviation|Mean
2570340|NCT02531633|Secondary|Part A: Mean Physician Global Assessment of Disease Activity (PhGA) Score Over Time|"The Physician's Global Assessments of Disease Activity was recorded on a VAS of 10 cm ranging from 0 (none) to 10 (extremely active)."|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Scores on scale||Standard Deviation|Mean
2570341|NCT02531633|Secondary|Part A: Mean Patient Global Assessment of Disease Activity (PtGA) Score Over Time|"The Patient's Global Assessments of Disease Activity was recorded on a Visual analog scale (VAS) of 10 centimeter (cm) ranging from 0 (very well) to 10 (very poor)."|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Scores on scale||Standard Deviation|Mean
2570342|NCT02531633|Secondary|Part A: Number of Participants With Patient Global Impression of Change (PGIC) Score Over Time|Patient-reported response to treatment was assessed using the PGIC measure, a single item completed by participant to provide a clinically meaningful summary of an individual's response to treatment. The assessment provides an estimate of the magnitude of treatment response at different time points during the study. Responses include: Much Better, Better, Slightly Better, No Change, Slightly Worse, Worse, and Much Worse. The categorical data of participant rating of change is summarized by treatment group, visit and response category.|Weeks 12, 24 and 52|ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2570343|NCT02531633|Secondary|Part A: Mean Health Assessment Questionnaire - Disability Index (HAQDI) Score Over Time|"Health Assessment Questionnaire-Disability Index (HAQ-DI) indicates the extent of participant's functional ability during the past week, and was assessed for subgroup of participants with symptoms of Polymyalgia Rheumatic (PMR). HAQ-DI included 20 questions in 8 categories of functioning - dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each functional area contains at least two questions. For each question, there is a 4-level difficulty scale that is scored from 0 (minimum) to 3 (Maximum), representing no difficulty (0), some difficulty (1), much difficulty (2), and unable to do (3) where, lower score indicates less disability and higher scores indicates worse disability. Total score was calculated as average scores of 20 questions which can be interpreted in terms of 3 categories: from 0 to 1: mild difficulties to moderate disability, from 1 to 2: disability moderate to severe, from 2 to 3: severe to very severe disability."|Baseline (Week 0) and Weeks 12, 24, 36 and 52|ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Scores on scale||Standard Deviation|Mean
2570344|NCT02531633|Secondary|Part A: Mean Pain Numeric Rating Scale (NRS) Scores Over Time|"The assessment of pain severity was made using a single pain severity item on which participants were asked to rate the severity of their average pain on a 11-point numeric rating scale ranging from 0, no pain to 10, the worst pain imaginable. Data for NRS scores over time for part A is reported."|Baseline (Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Scores on scale||Standard Deviation|Mean
2570353|NCT02531633|Secondary|Part A: Time to First Disease Flare After Clinical Remission|Clinical remission was defined as absence of clinical signs and symptoms of GCA, which was determined by a lack of flare for the participant. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to first disease flare (days) was calculated as (Date of First Flare - Date of Clinical Remission + 1 day). Data for Time to first disease flare after clinical remission for part A is presented.|Week 52|ITT Population. Only participants who achieved clinical remission were included in this analysis.|||Days||Inter-Quartile Range|Median
2570345|NCT02531633|Secondary|Part A: Mean Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-Fatigue) Scores Over Time|The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses participant reported fatigue and its impact upon daily activities and function over the past seven days. Participants were asked to answer each question using a 5-point Likert-type scale (4 = Not at all; 3 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 0 = Very Much) where 0 is a bad response and 4 is good response. Each of the 13 items of the FACIT-Fatigue Scale ranges from 0-4, with a range of possible total score from 0-52, 0 (Extreme fatigue) to 52 (No fatigue) where 0 being the worst possible score and 52 the best (i.e. less fatigue). Scores below 30 indicate severe fatigue. Each negatively-worded item response was recoded so that 0 is a bad response and 4 is good response. All responses were added with equal weight to obtain the total score. The total score was calculated as the sum of all the individual items after recoding some of the items.|Baseline (Week 0), Weeks 12, 24, 36, 52|ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Scores on scale||Standard Deviation|Mean
2570346|NCT02531633|Secondary|Part A: Mean EQ-5D-5L Visual Analogue Scale (VAS) Over Time|EQ-5D essentially consists of 2 elements: the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system comprised of the following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of the 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. The index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for the conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1 (best score). The EQ VAS records the respondent's self-rated health on a vertical line, VAS where the endpoints are 'Best imaginable health state' and 'Worst imaginable health state'.|Baseline (Week 0) and Weeks 12, 24, 36, 52|ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Scores on scale||Standard Deviation|Mean
2570347|NCT02531633|Secondary|Part A: Mean EuroQol - 5 Dimensions, 5 Levels (EQ-5D-5L) Index Score Over Time|EuroQoL-5 Dimensions consist of 2 elements: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprised of following 5 dimensions: 1.Mobility, 2.Self-Care, 3.Usual Activities, 4.Pain/Discomfort and 5.Anxiety/Depression. Each of these 5 dimensions has 5 levels: 1: no problems; 2: slight problems; 3: moderate problems; 4: severe problems; 5: Unable to do. The digits for each of 5 dimensions were combined in a 5-digit number describing the participant's health state: e.g. state 11111 indicates no problem on any of the 5 dimensions. Index score was derived from the 5 dimensions scores using UK tariff. The weights based from the UK population was used for conversion, regardless of the origin country of participant. The score ranged from -0.594 (worst score) to 1.000 (best score).|Baseline (Week 0) and Weeks 12, 24, 36, 52|ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Scores on scale||Standard Deviation|Mean
2570348|NCT02531633|Secondary|Part A: Mean 36-item Short Form Health Survey Version 2 (SF-36 v2) Acute Score Over Time|SF-36v2 acute health survey questionnaire consists of the following 8 multi-item scales: 1. Limitations in physical functioning due to health problems, 2. Limitations in usual role activities due to physical health problems, 3. Bodily pain, 4. General mental health (psychological distress and well-being), 5. Limitations in usual role activities due to personal or emotional problems, 6. Limitations in social functioning due to physical or mental health problems. 7. Vitality (energy and fatigue) and 8. General health perception. These 8 scales were scored from 0 to 100, 0 (worst score) to 100 (best score) where higher scores indicates better health. Data for Physical Component Summary (PCS), Mental Component Summary (MCS) scores was presented.|Baseline (Week 0), Weeks 12, 24, 36, 52|ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Scores on scale||Standard Deviation|Mean
2570349|NCT02531633|Secondary|Part A: Number of Hospitalizations for Disease Flare Over Time|Number of hospitalizations for disease flare at given visit is the number of hospitalizations for disease flare between first SC IP intake and the day of the of the given visit.. Data for number of hospitalizations for disease flare over time for part A was presented.|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Number of Hospitalizations|||Number
2570350|NCT02531633|Secondary|Part A: Number of Participants With at Least One Hospitalization for Disease Flare|Number of participants with at least one hospitalization for disease flare at a given visit is the number of participants with at least one hospitalization for disease flare between first SC IP intake and the day of the given visit. Data for participants requiring at least one hospitalization for disease flare for part A is presented.|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2570351|NCT02531633|Secondary|Part A: Number of Disease Flares Over Time|This summarizes disease flares over time with no adjustment for exposure to study drugs, calculated by taking the last visit before a participant withdrew and then counting the number of participants with at least 1 flare up to that point and summing up the total number of flares experienced by each of these participants; participants who did not reach Week 2 were not included in this analysis. Data for number of disease flares per participant over time for part A were presented.|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Disease flares|||Number
2570352|NCT02531633|Secondary|Part B: Time to First Disease Flare for Participants in Sustained Remission|Clinical remission was defined as absence of clinical signs and symptoms of GCA. If a participant had a flare, they had one or more signs and symptoms, and therefore are not considered as being in clinical remission. Time to event (days) is defined as the duration in days from the date of the Week 52 visit of Part A to the start date of Event (Date of First Flare - Date of Week 52 visit of Part A + 1). Data for Time to first disease flare after clinical remission for part B is presented.|Week 52|ITT-Part B Population. Only those participants with available data at the specified time points were analyzed.|||Days||Inter-Quartile Range|Median
2570354|NCT02531633|Secondary|Part B: Number of Participants in Sustained Remission Over Time|Sustained remission was defined as having achieved all of the following: 1) remission at Week 12 (absence of signs and symptoms of GCA and normalization of ESR and CRP), 2) absence of disease flare Week 12 through Week 52 with or without elevations in ESR and/or CRP, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30millimeters per hour] and CRP [<1milligram/deciliter]) and Flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission over time for Part B is presented. Only participants who were in sustained remission at Week 52 of Part A, who Completed the Week X Visit of Part B or who Withdraw before 10th of October 2017 were included in the analysis.|Weeks 4, 8 and 12|ITT-Part B Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2570355|NCT02531633|Secondary|Part A: Cumulative Prednisone Dose Over Time|Cumulative prednisone is the dose from the taper (both open-label and blinded) as well as from the corticosteroid rescue therapies. Cumulative dose at the specified Week was derived as the sum of all the doses from Baseline to the specified Week at each visit was calculated based on the number of participants who attended that visit. For the main analysis of cumulative prednisone dose over time. Data for Prednisone Dose- Study Drug and Prednisone Equivalent Concomitant Therapy for part A is presented. ITT population and the number of participants included at specific time points were based on the participants who attended a scheduled or unscheduled visit mapped to that time point and received a total prednisone dose greater than 0 mg.|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Milligrams||Standard Deviation|Mean
2570356|NCT02531633|Secondary|Part B: Number of Participants Who Remained in Sustained Remission Without Requirement for Rescue Therapy or Treatment Change at Week 24|Participants who remained in sustained remission without requirement for rescue therapy or treatment change at each scheduled visit of Part B were defined as participants having achieved all of the following criteria: 1. Participants in sustained remission at the Week 52 visit of Part A, 2. Absence of disease flare, 3. No requirement for rescue therapy at any time through Week 24 of Part B, 4. No requirement for treatment change at any time through Week 24 of Part B. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of ESR [<30 millimeters per hour] and CRP [<1 milligram/deciliter]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP.|Week 24|ITT-Part B Population included all randomized participants who received at least 1 dose of SC IP in Part A and entered Part B.|||Participants|||Count of Participants
2570357|NCT02531633|Primary|Part A: Number of Participants in Sustained Remission at Week 52|Sustained remission was defined as having achieved all of the following: 1) remission at Week 12, 2) absence of disease flare Week 12 through Week 52, 3) completion of the assigned prednisone taper, and 4) no requirement for rescue therapy through Week 52. Remission was defined as absence of clinical signs and symptoms of GCA and normalization of erythrocyte sedimentation rate (ESR) [<30 millimeters per hour] and C-reactive Protein (CRP) [<1 milligram/deciliter]) and flare was defined as recurrence of symptoms attributable to active GCA, with or without elevations in ESR and/or CRP. Data for number of participants in sustained remission at Week 52 is presented. Only those participants who completed Week 52 visit or withdrew before 10 Oct 2017 were included in the analysis.|Week 52|Intent-to-Treat (ITT) Population comprised of all randomized participants who received at least 1 dose of SC investigational product (IP).|||Participants|||Count of Participants
2570358|NCT02531438|Secondary|Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CT-PTE) Population|At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: survival after completion of a test article regimen without receiving any systemic antibacterial therapy other than test article, resolution of signs/symptoms of the infection present at Screening with no new symptoms/complications attributable to CABP and no need for further antibacterial therapy. Clinical Failure: alternative antibacterial treatment for CABP was required prior to the PTE Visit related to either (a) progression/development of new CABP symptoms or (b) development of infectious complications of CABP. Other reasons for clinical failure: participant received antibiotics that may have been effective for the infection under study for a different infection from the one under study; death prior to the PTE Visit.|Screening; 5 to 10 days after the last day of therapy|CE-PTE Population: all participants in the ITT Population meeting additional pre-defined criteria|||Participants|||Count of Participants
2570359|NCT02531438|Secondary|Number of Participants With the Indicated Investigator Assessment of Clinical Response in the ITT Population at the Post Therapy Evaluation (PTE) Visit|At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: survival after completion of a test article regimen without receiving any systemic antibacterial therapy other than test article, resolution of signs/symptoms of the infection present at Screening with no new symptoms/complications attributable to CABP and no need for further antibacterial therapy. Clinical Failure: alternative antibacterial treatment for CABP was required prior to the PTE Visit related to either (a) progression/development of new CABP symptoms or (b) development of infectious complications of CABP. Other reasons for clinical failure: participant received antibiotics that may have been effective for the infection under study for a different infection from the one under study; death prior to the PTE Visit. Indeterminate: the clinical response to test article could not be adequately inferred.|Screening; 5 to 10 days after the last day of therapy|ITT Population|||Participants|||Count of Participants
2570384|NCT02531022|Primary|Change in Mean Daily Steps|The primary outcome variable is the change in mean daily step count from the baseline period to the maintenance period (weeks 9-16).|Baseline and end of Maintenance Period at Week 16||||Steps||95% Confidence Interval|Mean
2570385|NCT02530970|Primary|Number of Participants With Major Pocket Infections|Incidence of major pocket infection included those with cellulitis in the region of the CIED pocket with wound dehiscence, erosion or purulent drainage, 2) deep incisional or organ/space (pocket) surgical site infection, 3) persistent bacteremia or 4) endocarditis.|Participants were followed for an average of 235.0 days.|Analysis population includes all study participants.|||Participants|||Count of Participants
2570360|NCT02531438|Primary|Number of Participants With Early Clinical Response|Early clinical response is defined as clinical success, categorized by survival with improvement of at least 1 level compared to Baseline in at least 2 CABP symptoms (cough, sputum production, pleuritic chest pain, and dyspnea) with no worsening in the other CABP symptoms. Response was determined programmatically using the investigator's assessment of the CABP symptoms. The severity of the participant's CABP symptoms was evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Subject Symptom Severity Guidance Framework for Investigator Assessment. An indeterminate response is defined as one that could not be adequately inferred because the participant was not assessed because they withdrew consent, were lost to follow-up, or other specified reason. Clinical failure is defined as no improvement by at least 1 level in CABP symptoms, worsening of any CABP symptom, alternative antibacterial treatment for CABP, discontinuation due to adverse event, or death.|Screening; 72 to 120 hours after the first dose of test article|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not the participant received the test article|||Participants|||Count of Participants
2570361|NCT02531373|Secondary|Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies|Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.|1 month after Vaccination 4 (Month 11-15)|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.|||µg/mL||95% Confidence Interval|Geometric Mean
2570362|NCT02531373|Secondary|Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies|Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.|Before Vaccination 4 (Month 10-13)|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.|||µg/mL||95% Confidence Interval|Geometric Mean
2570363|NCT02531373|Secondary|Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4|Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.|1 month after Vaccination 4 (Month 11-15)|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.|||Percentage of participants||95% Confidence Interval|Number
2570364|NCT02531373|Secondary|Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4|Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.|Before Vaccination 4 (Month 10-13)|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.|||Percentage of participants||95% Confidence Interval|Number
2570365|NCT02531373|Secondary|Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3|Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.|1 month after Vaccination 3 (Month 5)|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.|||Percentage of participants||95% Confidence Interval|Number
2570366|NCT02531373|Secondary|Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies|Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at 1 month after vaccination divided by concentration at baseline.|Baseline and 1 month after vaccination|The analysis population included all adult participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.|||Ratio||95% Confidence Interval|Geometric Mean
2570367|NCT02531373|Secondary|Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies|Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.|1 month after vaccination|The analysis population included all adult participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.|||µg/mL||95% Confidence Interval|Geometric Mean
2570368|NCT02531373|Primary|Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies|Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.|1 month after Vaccination 3 (Month 5)|The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.|||µg/mL||95% Confidence Interval|Geometric Mean
2570369|NCT02531373|Primary|Infants: Percentage of Participants With a Solicited Systemic Adverse Event|Solicited systemic AEs were irritability, decreased appetite, somnolence, and urticaria.|Up to 14 days after any vaccination|The analysis population included all randomized infant participants who received at least one dose of study vaccination and had follow-up for the outcome measure. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.|||Percentage of participants|||Number
2570370|NCT02531373|Primary|Infants: Percentage of Participants With a Solicited Injection-site Adverse Event|Solicited injection-site AEs were injection-site erythema, injection-site induration, injection-site pain, and injection-site swelling.|Up to 14 days after any vaccination|The analysis population included all randomized infant participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.|||Percentage of participants|||Number
2571696|NCT02513732|Secondary|Number of Participants With Death,Myocardial Infarction and Revascularization(DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|0 to 1 year|ITT population|||Participants|||Count of Participants
2570371|NCT02531373|Primary|Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to time of Vaccination 4 (Month 10-13)|The analysis population included all randomized infant participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.|||Percentage of participants|||Number
2570372|NCT02531373|Primary|Infants: Percentage of Participants With an Adverse Event|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to 1 month after Vaccination 4 (Month 11-15)|The analysis population included all randomized infant participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.|||Percentage of participants|||Number
2570373|NCT02531373|Primary|Adults: Percentage of Participants With an Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to 6 weeks after vaccination|The analysis population included all randomized adult participants who received study vaccination.|||Percentage of participants||95% Confidence Interval|Number
2570374|NCT02531321|Secondary|Serum Progesterone Level >3ng/dL Reflecting Ovulation|Progesterone >3ng/dL at any time during pill use|21 days|||||||
2570375|NCT02531321|Secondary|Ethinyl Estradiol Area Under the Curve|Ethinyl estradiol area under the curve from 0 to 72 hours|24 days||||ng/mL*h||Standard Deviation|Mean
2570376|NCT02531321|Primary|Levonorgestrel Area Under the Curve|Levonorgestrel AUC from 0 to 72 hours|24 days||||ng/mL*h||Standard Deviation|Mean
2570377|NCT02531308|Primary|Progression Free Survival|rate of progression in patients 2 years after diagonosis|2 year|Study terminated prematurely.||||||
2570378|NCT02531035|Secondary|Percent Change From Baseline in Mean Daily Bolus Insulin Dose|The mean bolus insulin dose in international units/day (IU/day) for Week 24 was the average over the 3 to 5 days prior to the Week 24 visit. The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post Baseline values. A negative percent change from Baseline indicated a reduction in the amount of bolus insulin used and a positive percent change from Baseline indicated an increase in the amount of bolus insulin used between Baseline and Week 24.|Baseline to Week 24|"Analyses included participants from the mITT population. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure."|||percent change in IU/day||Standard Error|Least Squares Mean
2570379|NCT02531035|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) in the Subset of Participants With Baseline SBP >=130 Millimeter of Mercury (mmHg)|An automatic sphygmomanometer was used with instructions on blood pressure measurements to allow for standardization. Week 16 was used because the protocol required Investigators to keep participant's hypertensive medications stable between Baseline and Week 16, unless a change was required for safety reasons. Baseline was defined as the last value collected prior to the first does of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change indicates a decrease in SBP between Baseline and Week 16.|Baseline to Week 16|"Participants from mITT population and who had a Baseline SBP >= 130 mm Hg. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure."|||mmHg||Standard Error|Least Squares Mean
2570380|NCT02531035|Secondary|Absolute Change From Baseline in Body Weight|Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative change from Baseline indicates a loss in body weight from Baseline to Week 24.|Baseline to Week 24|"Analyses included participants from the mITT population. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure."|||kilograms (kg)||Standard Error|Least Squares Mean
2570381|NCT02531035|Secondary|Change From Baseline in A1C|Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least Squares (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) model including all available post baseline data. A negative change from Baseline (a lower AIC value at Week 24) indicates an improvement.|Baseline to Week 24|Analyses included participants from the mITT population. Here, “overall number of participants analyzed” signifies participants who were evaluable for this outcome measure.|||percentage of A1c||Standard Error|Least Squares Mean
2570382|NCT02531035|Primary|Percentage of Participants With A1C <7.0% at Week 24 and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) After Randomization|The primary composite endpoint included blood samples for the assessment of Hemoglobin A1C to determine the participants with a value <7.0%. A central blinded adjudication process determined whether participants experienced either DKA or Severe Hypoglycemia.|Week 24|The primary efficacy analyses were based on the modified Intent-to-Treat (mITT) population.|||percentage of participants|||Number
2570383|NCT02531022|Secondary|Change in Mean Daily Steps From Baseline to Follow-up Period|Secondary outcomes include change in mean daily steps from the baseline period to the follow-up period (weeks 17-24).|Baseline and end of Follow Up Period at week 24||||Steps||95% Confidence Interval|Mean
2570388|NCT02530671|Primary|Bristle Splay Index (BSI) After a Specific Time-of-use|A digital computer program (ImageJ, NIH, Bethesda, MD, USA) for evaluating the index was applied. All brushes were photographed from both top and side view in a standardized set-up including a benchmark (Lego GmbH (Gemeinschaft mit beschränkter Haft), Grasbrunn, Germany) as reference for measurement. Subsequently, an independent examiner (N.H.) measured the lengths twice. To devise the BSI formula the results were averaged and inserted. The formula is defined by: BSI (%) = ((a´- a)/a + (b´- b)/b + (c´- c)/c + (d´- d)/d)/4 x 100. BSI was standardized for usage time by dividing it by the number of days used (BSI/T).|3, 6, 9 and 12 months||||percentage of the original bristle field||Standard Deviation|Mean
2570389|NCT02530671|Secondary|Pocket Probing Depths at 12months||12 months||||mm||Standard Deviation|Mean
2570390|NCT02530671|Secondary|Percentage of Recession Sites Demonstrating a Change of ≥1mm||12 months||||percentage of sites|||Number
2570391|NCT02530671|Secondary|Recession at All Buccal Sites||12 months||||mm||Standard Deviation|Mean
2570392|NCT02530671|Primary|Gingival Recession at Sites With Preexisting Recessions ≥2mm||12 months||||mm||Standard Deviation|Mean
2570393|NCT02530515|Secondary|Incidence of Infections|To study the incidence of infections for up to 1 year following activated T cell infusion|Up to 1 year|Data was not collected due to low accrual||||||
2570394|NCT02530515|Secondary|Overall Response Rates|The overall response rates between the lenalidomide and non-lenalidomide arms. For response to treatment, it was measured by International Workshop on CLL (iwCLL), criteria 2008 guidelines.|Up to 1 year|Data was not collected due to low accrual||||||
2570395|NCT02530515|Secondary|Immune Reconstitution|To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia|Up to 1 year|Data was not collected due to low accrual||||||
2570396|NCT02530515|Primary|Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT.|Success will be defined as achievement of a target activated T-cell dose of 1x108 +/-20% without DLT and the lack of dose limiting toxicity (DLT). DLT for this trial is defined as any Grade 4 or higher non-hematologic toxicity or grade 3 or 4 allergy/immunology toxicity, allergic reaction or urticaria grade 3 or higher by +90 days after T cell infusion, Grade 2 or greater autoimmune phenomena, or Grade 4 or higher hematologic toxicity (with the exception of any preexisting AE due to prior treatment or due to disease) deemed related to T cells and occurring by day +90 after T cell infusion. Feasibility is defined as achievement of the target T-cell dose (1x108 +/-20% ) without DLT in >50% of patients enrolled.|Enrollment up to day 100 post T cell infusion for each arm.|Patients with CLL.|||Participants|||Count of Participants
2570397|NCT02530476|Secondary|Event Free Survival|Time from date of treatment start until the date of first objective documentation of disease-relapse.|Up to 6 months|Event Free Survival was not an objective outlined for participants in Phase I Group's 1 and 2, therefore overall survival was not done for these participants. Of the seven participants in cohort 1, one participant was not evaluable for response. Of the three participants in cohort 2, one participant was not evaluable for response.|||Months||Full Range|Median
2570398|NCT02530476|Secondary|Overall Survival|Time from date of treatment start until date of death due to any cause or last Follow-up.|Up to 15 months, on average 5 months|Overall Survival was not an objective outlined for participants in Phase I Group's 1 and 2, therefore overall survival was not done for these participants. Of the seven participants in cohort 1, one participant was not evaluable for response. Of the three participants in cohort 2, one participant was not evaluable for response.|||Months||Full Range|Median
2570399|NCT02530476|Primary|Composite CR (CRc) Rate Defined as CR (Complete Remission) + CRp (Complete Remission With Incomplete Platelet Recovery) + CRi (Complete Remission With Incomplete Count Recovery) Within 3 Months of Treatment Initiation|"CRc Response criteria modified from International Working Group for AML. Responders obtain a Composite Complete Remission Rate (CRc) with or without cytogenetic response, hematologic improvements, and morphologic leukemia-free state. CRc rate is defined as the confirmed remission rate of all complete and incomplete CRs (i.e., CR+ CRp + CRi).~CR: bone marrow regenerating normal hematopoietic cells & morphologic leukemia-free state, & ANC > 1×10^9/L, platelet count ≥100×10^9/L, & normal marrow differential with <5% blasts, & red blood cell (RBC) and platelet transfusion independent, no evidence of extramedullary leukemia. CRp: CR except for incomplete platelet recovery (<100×10^9/L). CRi: Same criteria for CR except incomplete hematological recovery with residual neutropenia (ANC ≤ 1 × 109/L) with or without thrombocytopenia (platelet count <100×109/L). No need to be RBC or platelet transfusion independent (modification to Cheson criteria)."|84 days, assessed following first three cycles of therapy of Selinexor with Sorafenib|Of the four participants in the Phase I Group 1 Selinexor + Sorafenib arm, one participant was not evaluable for response. Of the seven participants in cohort 1, one participant was not evaluable for response. Of the three participants in cohort 2, one participant was not evaluable for response.|||Participants|||Count of Participants
2570400|NCT02530476|Primary|Maximum Tolerated Dose (MTD) of Selinexor With Sorafenib|MTD defined as the highest dose level with </= 1 out of 6 patients experience a dose limiting toxicity (DLT) during the first 28 days of treatment.|28 days|The Outcome Measure of MTD was the objective of the Phase I Selinexor + Sorafenib cohort only. Data for MTD were not collected for patients on Cohorts 1 and 2.|||Milligrams|||Number
2570401|NCT02530450|Secondary|% Time Spent in Hypoglycemia, Hyperglycemia, and Euglycemia||3 months and 6 months|||||||
2570402|NCT02530450|Primary|The Primary Outcome Measure Was Change in HgbA1c||0 months, 3 months and 6 months||||HbgA1c %||Inter-Quartile Range|Median
2570403|NCT02530385|Secondary|Fat Mass|Change in fat mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry|Baseline and 12 weeks||||kg||Standard Deviation|Mean
2570404|NCT02530385|Secondary|Lean Mass|Change in lean mass from baseline to 12 weeks measured via dual-energy x-ray absorptiometry|Baseline and 12 weeks||||kg||Standard Deviation|Mean
2570405|NCT02530385|Secondary|Body Weight (Metabolic Scale)|Change in body weight from baseline to 12 weeks will be measured on a metabolic scale.|Baseline and 12 weeks||||kg||Standard Deviation|Mean
2570406|NCT02530385|Secondary|Change in Insulin Resistance Based on Homeostasic Model Assessment of Insulin Resistance (HOMA-IR)||Baseline and 12 weeks||||unitless||Standard Deviation|Mean
2570409|NCT02530294|Secondary|Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4|Hyperhidrosis Disease Severity Scale (HDSS) is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects' condition based on how it affects daily activities.|From Baseline to Week 4|Participant|||percent of subjects|||Number
2570410|NCT02530294|Primary|Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4||From Baseline to Week 4|Participant|||mg/5 min||Inter-Quartile Range|Median
2570411|NCT02530294|Primary|Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4|Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject's axilla with the arm down by the subject's side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min.|Baseline - Week 4|Participant|||mg/5 min||Standard Deviation|Least Squares Mean
2570412|NCT02530294|Primary|Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of Axillary Sweating Daily Diary (ASDD) Item #2 From Baseline at Week 4|"The Axillary Sweating Daily Diary (ASDD) is a 4-item instrument designed to measure the severity of axillary hyperhidrosis and its impact on daily activities. The 4 Items are:~During the past 24 hours, did you have any underarm sweating? (Yes or No)~During the past 24 hours, how would you rate your underarm sweating at its worst? (0=No sweating at all, 1, 2,…, 10=Worst possible sweating)~During the past 24 hours, to what extent did your underarm sweating impact your activities? (0=Not at all, 1=A little bit, 2=A moderate amount, 3=A great deal and 4=An extreme amount)~During the past 24 hours, how bothered were you by your underarm sweating? (0=Not at all bothered, 1=A little bothered, 2=Moderately bothered, 3=Very bothered, 4=Extremely bothered)"|From Baseline to Week 4|Participant|||percent of subjects|||Number
2570413|NCT02530281|Secondary|Percentage of Subjects Who Have at Least a 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4||From Baseline to Week 4|Participant|||percent of subjects|||Number
2570414|NCT02530281|Secondary|Percentage of Subjects Who Have a ≥2 Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) From Baseline at Week 4|"Hyperhidrosis Disease Severity Scale (HDSS) is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects' condition based on how it affects daily activities.~1 (Best), 2, 3, 4 (Worst)"|From Baseline to Week 4|Participant|||percent of subjects|||Number
2570415|NCT02530281|Primary|Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4, Excluding Centers With Outlier Data||Baseline - Week 4|Participant|||mg/5 min||Standard Deviation|Least Squares Mean
2570416|NCT02530281|Primary|Median Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4||From Baseline to Week 4|Participant|||mg/5 min||Inter-Quartile Range|Median
2570417|NCT02530281|Primary|Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4|Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject's axilla with the arm down by the subject's side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min.|From Baseline to Week 4|Participant|||mg/5 min||Standard Deviation|Least Squares Mean
2570418|NCT02530281|Primary|Percentage of Subjects Who Have a ≥4-point Improvement in the Weekly Mean Score of ASDD Item #2 From Baseline at Week 4|"The Axillary Sweating Daily Diary (ASDD) is a 4-item instrument designed to measure the severity of axillary hyperhidrosis and its impact on daily activities. The 4 Items are:~During the past 24 hours, did you have any underarm sweating? (Yes or No)~During the past 24 hours, how would you rate your underarm sweating at its worst? (0=No sweating at all, 1, 2,…, 10=Worst possible sweating)~During the past 24 hours, to what extent did your underarm sweating impact your activities? (0=Not at all, 1=A little bit, 2=A moderate amount, 3=A great deal and 4=An extreme amount)~During the past 24 hours, how bothered were you by your underarm sweating? (0=Not at all bothered, 1=A little bothered, 2=Moderately bothered, 3=Very bothered, 4=Extremely bothered)"|From Baseline to Week 4|Participant|||percent of subjects|||Number
2570419|NCT02530151|Secondary|Quality of Recovery (QoR-15) Scores for Patient Reported Recovery Following Surgery|The Quality of Recovery questionnaire (QoR-15) is a 15 question patient reported outcome measure used to evaluate the quality of recovery following surgical anesthesia concerning pain, physical function, and psychological factors; reported as a summative score with each question graded between 0-10 (Range:0-150) with higher scores indicating improved physical/psychological recovery or infrequent symptoms|Preoperative to 24 hrs. post operatively||||score on a scale||95% Confidence Interval|Mean
2570420|NCT02530151|Secondary|Visual Analog Scale (VAS) Pain Scores|Patients will rate their pain (0-10) on the Visual Analog Scale with higher scores for the VAS indicated elevated pain intensity reported by the patient for the indicated time point|Immediately preoperative (5-10 minutes before surgery), immediately postoperative (5-10 minutes after surgery), 1 hr post operatively||||score on a scale||95% Confidence Interval|Mean
2570421|NCT02530151|Primary|Opioid Consumption in the Acute Postoperative Period|The total usage of opioid medication (mEq) for pain relief in the intraoperative period and again through the postoperative recovery period from arrival in the PACU through 7 days post op|Recorded intraoperatively, during PACU stay, 6 hours post discharge, 18 hours post discharge, 24 hours post discharge, 48 hours post discharge, and at 7 days post discharge|Patients that failed to complete the necessary follow up for all time points following discharge (6 hrs/18 hrs/24 hrs/48 hrs) were excluded from final analysis for the respective time points|||milligram morphine equivalents (mEq)||95% Confidence Interval|Mean
2570422|NCT02530125|Other Pre-specified|PD-1 and PD-L1 Pathway Specific Expression Markers|Tissue sample slides from the diagnostic biopsy will be evaluated by immunohistochemistry for expression of PD-1 and PD-L1. Presence/absence (binary) of PD-1 and PD-L1 will be correlated with response to pidilizumab and clinical outcomes.|Baseline to up to 127 days. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.|Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.||||||
2571697|NCT02513732|Secondary|Number of Participants With Death,Myocardial Infarction and Revascularization(DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|0 to 8 months|ITT population|||Participants|||Count of Participants
2570423|NCT02530125|Other Pre-specified|Levels of Serum Biomarkers of Immune and Inflammatory Response|Peripheral blood will be tested for serum levels of TNF-α, IFN-γ, IL-2, IL- 7, IL-9, and galectin-1. Levels will be compared from specified time points through treatment.|Baseline to up to 127 days. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.|Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.||||||
2570424|NCT02530125|Other Pre-specified|Change in Soluble PD-L1 Levels|Peripheral blood obtained at day 1 and day 127 will be analyzed and levels will be compared to evaluate for a change (increase/decrease) following treatment with pidilizumab.|Baseline to up to 127 days. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.|Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.||||||
2570425|NCT02530125|Secondary|Time to Second Line Chemotherapy (TSLC)|To estimate time to second line chemotherapy (TSLC) at 2 years|Up to 2 years|Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.||||||
2570426|NCT02530125|Secondary|Relapsed Disease||Up to 2 years. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.|Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.||||||
2570427|NCT02530125|Secondary|Progression Free Survival (PFS)|To estimate the progression free survival (PFS) at 2 years. PFS will be defined as time from study enrollment until the first occurrence of disease relapse, progression, re-initiation of cytotoxic chemotherapy, or death due to disease, or until last contact if the patient did not experience any of these.|Up to 2 years. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.|Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.||||||
2570428|NCT02530125|Secondary|Overall Survival (OS)|To estimate the overall survival (OS) at 2 years|From study enrollment until death, or until last contact, assessed up to 2 years. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.|Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.||||||
2570429|NCT02530125|Secondary|The Frequency and Severity of Toxicity - Number of Grade 1, 2, 3, 4, and 5, Adverse Events Experienced During Treatment of Pidilizumab Defined by NCI CTCAE v 4.03.|"Adverse events (AEs) were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0. In general, AEs are graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|Start of treatment, and at days 22, 43, 85, 127 and every 3 months for up to 2 years. Due to early termination of the study, AEs for all patients were collected throughout treatment and up to the point of termination of the study.|This is only based of of 4 patients that received treatment of pidilizumab. Study terminated early due to manufacturer decision to discontinue pidilizumab.|||Adverse events|||Number
2570430|NCT02530125|Primary|Response to Pidilizumab|Response will be defined as the proportion of CD4+CD25+PD-L1+ T lymphocytes and CD4+CD62L+CD127+ T lymphocytes responders. Responders are defined as either a) a 50% increase or b) a half standard deviation increase in lymphocyte subsets. Lymphocyte subsets will be evaluated by flow cytometry on peripheral blood obtained at specified time points through the treatment period.|Baseline to up to 127 days. Study terminated before this timeframe. As a result insufficient data was collected to be analyzed.|Study terminated early due to manufacturer decision to discontinue pidilizumab. As a result insufficient data was collected to be analyzed.||||||
2570431|NCT02529995|Secondary|Objective Response Rate (ORR)|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.|Treatment discontinuation plus 28 days or 12 months after last subject first dose (LSFD). Results are based on data cut off of 2 Nov 2016.|All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.|||% of participants||95% Confidence Interval|Number
2570432|NCT02529995|Primary|CL(ss)/F of AZD9291 After Multiple Dosing|Pharmacokinetics of AZD9291 after multiple dosing by assessment of apparent plasma clearance at steady state|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||L/h||Standard Deviation|Mean
2570433|NCT02529995|Primary|AUC(ss) of AZ7550 After Multiple Dosing|Pharmacokinetics of AZD9291 metabolites (AZ7550) after multiple dosing by assessment of area under the plasma concentration curve from time zero to the end of the dosing interval|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2570434|NCT02529995|Primary|AUC(ss) of AZ5104 After Multiple Dosing|Pharmacokinetics of AZD9291 metabolites (AZ5104) after multiple dosing by assessment of area under the plasma concentration curve from time zero to the end of the dosing interval|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2570435|NCT02529995|Primary|AUC(ss) of AZD9291 After Multiple Dosing|Pharmacokinetics of AZD9291 after multiple dosing by assessment of area under the plasma concentration curve from time zero to the end of the dosing interval|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2570436|NCT02529995|Primary|C(ss, Max) of AZ7550 After Multiple Dosing|Pharmacokinetics of AZD9291 metabolites (AZ7550) after multiple dosing by assessment of maximum plasma concentration at steady state|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2570437|NCT02529995|Primary|C(ss, Max) of AZ5104 After Multiple Dosing|Pharmacokinetics of AZD9291 metabolites (AZ5104) after multiple dosing by assessment of maximum plasma concentration at steady state|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2570438|NCT02529995|Primary|C(ss, Max) of AZD9291 After Multiple Dosing|Pharmacokinetics of AZD9291 after multiple dosing by assessment of maximum plasma concentration at steady state|PK blood samples are collected multiple times on Cycle 1 Day 8 and Cycle 2 Day 1. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2570439|NCT02529995|Primary|CL/F of AZD9291 After Single Dosing|Rate and extent of absorption of single dose AZD9291 by assessment of apparent clearance following oral administration|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||L/h||Standard Deviation|Mean
2570440|NCT02529995|Primary|AUC of AZ7550 After Single Dosing|Pharmacokinetics of AZD9291 metabolites (AZ7550) after single dosing by assessment of area under the plasma concentration time curve from zero to infinity|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2570441|NCT02529995|Primary|AUC of AZ5104 After Single Dosing|Pharmacokinetics of AZD9291 metabolites (AZ5104) after single dosing by assessment of area under the plasma concentration time curve from zero to infinity|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2570442|NCT02529995|Primary|AUC of AZD9291 After Single Dosing|Pharmacokinetics of AZD9291 after single dosing by assessment of area under the plasma concentration time curve from zero to infinity|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2570443|NCT02529995|Primary|Cmax of AZ7550 After Single Dosing|Pharmacokinetics of AZD9291 metabolites (AZ7550) after single dosing by assessment of maximum plasma concentration|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2570444|NCT02529995|Primary|Cmax of AZ5104 After Single Dosing|Pharmacokinetics of AZD9291 metabolites (AZ5104) after single dosing by assessment of maximum plasma concentration|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2570445|NCT02529995|Primary|Cmax of AZD9291 After Single Dosing|Pharmacokinetics of AZD9291 after single dosing by assessment of maximum plasma AZD9291 concentration|PK blood samples are collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post-dose. Results are based on data cut off of 28 Jan 2016.|Pharmacokinetic population - all patients who received at least 1 dose of AZD9291 and had at least 1 quantifiable plasma concentration collected post-dose without important protocol deviations/violations. Overall number of participants analyzed is the number of patients in Pharmacokinetic population who had available data for each PK variable.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2570446|NCT02529553|Secondary|Number of Participants With Tumor Response|Tumor response was assessed using confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST version 1.1). Complete response (CR) was the disappearance of all target and non-target lesions and normalization of tumor marker levels of non-target lesions; partial response (PR) was at least a 30% decrease in the sum of the longest diameter of target lesions.|Baseline through Study Completion (Cycle 3, day 21)|All enrolled participants.|||participants|||Number
2570447|NCT02529553|Secondary|PK: Area Under the Concentration-Time Curve (AUC) of LY3076226||Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours|All participants with adequate measurable PK concentrations.|||μg per day per mL(μg/day/mL)||Geometric Coefficient of Variation|Geometric Mean
2570448|NCT02529553|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3076226||Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours|All participants with adequate measurable PK concentrations.|||Micrograms per milliliter(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2570449|NCT02529553|Primary|Maximum Tolerated Dose (MTD) of LY3076226|The MTD was defined as the highest dose tested that had less than 33% probability of causing a dose limiting toxicity (DLT).|Cycle 1 (21 Days)|All participants enrolled in dose escalation.|||milligrams|||Number
2570450|NCT02529488|Primary|Mean Binocular Defocus Visual Acuity (VA)|Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best spectacle correction at a distance of 4 meters. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. The defocus VA summaries are based on the number of subjects evaluable for Best-Case Analysis Set and have data available at the corresponding visit. No formal statistical hypothesis testing was planned.|Day 20-40 and Day 120-180 from second eye implantation|This analysis population includes all eyes successfully implanted with the test article that had at least 1 postoperative visit, no previous surgery for correction of refractive errors, no preoperative ocular pathology or macular degeneration at any time, no pregnancy during the study, and no major protocol deviations (Best-Case Analysis Set).|||logMAR||Standard Deviation|Mean
2570451|NCT02529137|Primary|Major Discordance Rate|"The primary endpoint was the difference in major discordance rates between Manual Optical (MO) and Manual Digital (MD). MO is defined as reading by using optical microscope whereas MD is defined as reading by using PIPS. MO major discordance rate is defined as the proportion of major discordances between the MO diagnosis and the main diagnosis from the total number of readings.~MD major discordance rate is defined as the proportion of major discordances between the MD diagnosis and the main diagnosis from the total number of readings."|6 months|8 cases were discontinued for reasons such as broken/damaged slide (1), slide size did not meet the scanner specifications (4), no tissue detected by the scanner (2) and more than one case was selected for the patient (1).|||percentage of major discordance|Readings|95% Confidence Interval|Number
2570452|NCT02529072|Secondary|Progression Free Survival (PFS)|PFS is defined as the time between treatment initiation and initial progression or death, or date of last follow-up if the patient remains alive without disease progression. The Kaplan-Meier estimator will be used to describe the PFS experience of all patients. Median PFS is presented. Patients who are not able to tolerate nivolumab and are removed from the study will not be included in these analyses. Patients for whom DC vaccines cannot be manufactured will not be included in the survival analyses. Tumor assessment will be made using Response Assessment in Neuro-Oncology (RANO) criteria, which defines progressive disease as an increase by at least 25% in the sum of the products of perpendicular diameters from the baseline scan, a significant increase in T2/FLAIR non-enhancing lesions, or clinical decline|6 to 48 months from study initiation|All randomized patients are included in this analysis|||months||95% Confidence Interval|Median
2570453|NCT02529072|Secondary|Overall Survival|Survival is defined as the time between first initiation of nivolumab and death, or last follow-up if the patient remains alive. The Kaplan-Meier estimator will be used to describe the overall survival (OS) experience of all patients. Median OS is presented. Patients who are not able to tolerate nivolumab and are removed from the study will not be included in these analyses. Patients for whom DC vaccines cannot be manufactured will not be included in the survival analyses.|approximately 4 years from study initiation|All randomized patients are included in this analysis|||months||95% Confidence Interval|Median
2570454|NCT02529072|Primary|The Safety of Administering DC Vaccines With Nivolumab|The percentage of patients who experience unacceptable toxicity during combination treatment by arm is tabulated. Unacceptable toxicity is defined as any grade 3, 4, or 5 adverse event that is possibly, probably, or definitely related to either nivolumab or DC vaccination treatment during concurrent treatment, or any Grade 2 drug-related uveitis or eye pain or blurred vision that does not respond to topical therapy and does not improve to Grade 1 severity within the re-treatment period OR requires systemic treatment. In addition, any complication following resection (ex. excessive intracranial bleeding, delays in wound healing) that are prolonged longer than 4-6 weeks post-surgery will be considered an unacceptable toxicity.|12 months|All randomized patients are included in this analysis|||Percentage of patients|||Number
2570466|NCT02528500|Secondary|Patency (Primary, Assisted Primary, and Secondary)|Primary Patency - Blood flow without occlusion maintained through the device without an intervention. Assisted Primary Patency: Blood flow maintained through the device after implant regardless of re-interventions performed. Secondary Patency - Blood flow through the device (following occlusion) regardless of re-interventions performed and freedom from surgical bypass.|Ongoing thoughout enrollment ; Final Analysis when available Subjects have completed 12-month follow-up assessment|||||||
2570455|NCT02528786|Primary|Number of Participants in Each Cluster|Clusters are described by an ellipse whose major and minor axes are the standard deviations in the x and y directions of the component points, which are rotated so that their covariance is equal to zero. The clusters were based upon the algorithms in which each data-point is assigned to one of four clusters: 1, 2, 3, or 4, representing no-target (negative controls [NTCs]), homozygotes one (XX), homozygotes two (YY), and heterozygotes (XY), respectively. Based on the calculated genetic composite scores from 8-single-nucleotide polymorphism (SNP)-based algorithm, participants were segregated into clusters.|Baseline|The analysis set included all participants who were enrolled and completed the study.|||participants|||Number
2570456|NCT02528721|Primary|Overall Agreement in Determining Presence or Absence of H.Pylori Infection Compared to Biopsy|Overall Agreement of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result|9 months|"According to the FDA Guidelines, if there is a discrepancy between the histology and the rapid urease test results (composite reference standard), the subject is considered unevaluable and thus not included in the analysis."|||Percent overall agreement||95% Confidence Interval|Number
2570457|NCT02528721|Primary|Specificity as Described as the Accuracy of the Breath Test in Detecting Absence of H.Pylori Infection Compared to Biopsy|Specificity of urea breath test with Dual Mode Breath Hp System in accurately detecting lack of presence of H.pylori infection as compared to composite biopsy result|9 months|"According to the FDA Guidelines, if there is a discrepancy between the histology and the rapid urease test results (composite reference standard), the subject is considered unevaluable and thus not included in the analysis."|||Percent negative agreement||95% Confidence Interval|Number
2570458|NCT02528721|Primary|Sensitivity is Described as the Accuracy of the Breath Test in Detecting H.Pylori Infection Compared to Biopsy|Sensitivity of urea breath test with Dual Mode Breath Hp System in accurately detecting presence of H.pylori infection as compared to composite biopsy result|9 months|"According to the FDA Guidelines, if there is a discrepancy between the histology and the rapid urease test results (composite reference standard), the subject is considered unevaluable and thus not included in the analysis."|||Percent positive agreement||95% Confidence Interval|Number
2570459|NCT02528643|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of randomization until the date of documented radiographic disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the investigator or death from any cause on study, whichever occurred first. The earliest of the censoring times was used: Participants with (1) no evaluable postbaseline imaging assessments or did not die were censored at the randomization date; (2) no radiographical progression or did not die before analysis cutoff date were censored at the last radiological assessment date before analysis cutoff date; (3) with no radiographical progression or did not die before new HCC treatment was censored at the last radiological assessment date before start of new HCC treatment. Based on Kaplan-Meier.|From date of randomization up to data cut-off date 02 Oct 2017 (approximately 22 months); median follow-up time was 14.65 months for enzalutamide and 13.83 for placebo.|The analysis population was the FAS. Participants who died after receiving the first dose of enzalutamide without postbaseline tumor assessments evaluable using RECIST 1.1, were considered to have a PFS event on the date of death.|||months||95% Confidence Interval|Median
2570460|NCT02528643|Secondary|Plasma Trough Concentrations of MDPC0001 (M2 Metabolite)|Blood samples were collected for analysis.|Predose at weeks 5, 9 and 13|The analysis population was the PKAS, with participants who had available concentration data.|||μg/mL||Standard Deviation|Mean
2570461|NCT02528643|Secondary|Plasma Trough Concentrations N-desmethyl Enzalutamide (M1 Metabolite)|Blood samples were collected for analysis.|Predose at weeks 5, 9 and 13|The analysis population was the PKAS, with participants who had available concentration data.|||μg/mL||Standard Deviation|Mean
2570462|NCT02528643|Secondary|Plasma Trough Concentrations of Enzalutamide|Blood samples were collected for analysis.|Predose at weeks 5, 9 and 13|The analysis population was the pharmacokinetics analysis set (PKAS), consisted of the subset of the SAF population for whom at least 1 quantifiable enzalutamide and N-desmethyl enzalutamide concentration value was available. Participants who had available concentration data were included in the analysis.|||μg/mL||Standard Deviation|Mean
2570463|NCT02528643|Secondary|Number of Participants With Adverse Events (AEs)|Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A treatment-emergent AE (TEAE) was defined as an AE observed after starting administration of the study drug up to 30 days after last dose of study drug or initiation of new treatment, whichever comes first. AEs were considered as serious if resulted in in death, was life-threatening resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization and other medically important events.|From first dose of study drug up to 30 days after last dose of study drug (up to data cut-off 02 Oct 2017, approximately 660 days); median (minimum, maximum) treatment duration was 71.0 (6, 574) days for enzalutamide and 64.0 (13, 385) for placebo.|The analysis population was the safety analysis set (SAF), which consisted of all participants who have received at least 1 or partial capsule of study drug.|||Participants|||Count of Participants
2570464|NCT02528643|Primary|Overall Survival (OS)|OS was defined as the time from the date of randomization until the documented date of death from any cause. Participants who were still alive at the time of the data cut-off date was censored on the last date known to be alive or at the data cutoff date, whichever occurs first. Results based on Kaplan-Meier estimates.|From date of randomization up to data cut-off date 02 Oct 2017 (approximately 22 months); median follow-up time was 14.65 months for enzalutamide and 13.83 for placebo.|The analysis population was the FAS.|||months||95% Confidence Interval|Median
2570465|NCT02528500|Secondary|Absence of Type I and Type III Endoleaks at One Month Follow-up|Absence of Type I and Type III endoleaks|One Month followup|||||||
2570486|NCT02528305|Primary|"Physical Function-Get up and go Test"|participant will be timed standing up from chair unaided,walking 30m, turning round and returning to a seated position on the chair, the average time of 3 attempts will be recorded.|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||seconds||Standard Deviation|Mean
2570467|NCT02528500|Secondary|Device Integrity, Including Individual Components of Device Integrity|Components of Device Integrity: Loss of functional patency in any treated branch component due to thrombus or mechanical failure of branch component, loss of functional patency in main body component(s) due to thrombus or mechanical failure of main body components(s) , separation of treated branch component from the main body component(s), separation of the main body component(s) from the accessory components|Ongoing thoughout enrollment ; Final Analysis when available Subjects have completed 12-month follow-up assessment|||||||
2570468|NCT02528500|Secondary|Technical Success, Including Individual Components of Technical Success|Components of Technical Success: Successful access to the necessary arterial sites, successful deployment of all required TAMBE Device components, Patency of all required TAMBE Device components and any required accessory components on completion angiography, absence of surgical conversion within 24 hours of initial of procedure|Ongoing thoughout enrollment ; Final Analysis when available Subjects have completed 12-month follow-up assessment|||||||
2570469|NCT02528500|Primary|Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL|Absence of the following procedural safety events through 30 days post-procedure: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL|Absence of procedural safety events through 30 days post procedure||||Participants|||Count of Participants
2570470|NCT02528331|Secondary|Percentage of Adverse Events||6 weeks||||percentage of adverse events|||Number
2570471|NCT02528331|Secondary|Partial Response Rate, as Measured by Y-BOCS|Partial response is defined as a reduction of greater than 25%.|6 weeks||||percentage of participants|||Number
2570472|NCT02528331|Secondary|Complete Response, as Measured by Y-BOCS|Complete response is defined as a reduction of Y-BOCS score greater than 35%.|6 weeks||||percentage of participants|||Number
2570473|NCT02528331|Primary|Remission Rate, as Measured by Y-BOCS|Remission is defined as end-point Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score less than the value of 16.|6 weeks||||percentage of participants|||Number
2570474|NCT02528318|Other Pre-specified|nCPAP Failure Without Treatment Interruptions|Number of subjects requiring mechanical ventilation or surfactant administration (nCPAP failure) but did not have a treatment interruption|Randomization to 72 Hours Post Randomization|Intent-to-Treat Without Treatment Interruption|||Participants|||Count of Participants
2570475|NCT02528318|Secondary|Number of Participants With Complications of Prematurity|Number of participants with pre-specified common complications of prematurity.|Randomization to 36 weeks PMA|Safety Population|||Participants|||Count of Participants
2570476|NCT02528318|Secondary|FiO2|"Observed and change from baseline measurements for fraction of inspired oxygen (FiO2). Values represent the amount (fraction) of oxygen in the air the participant inspires; the values themselves do not have units. The normal amount of oxygen in air (room air) is 21%, or 0.21."|Randomization to 72 hours post randomization|Safety Population|||Fraction of oxygen in inspired air||Standard Deviation|Mean
2570477|NCT02528318|Secondary|Death|Number of participants who died during the study|Randomization to 36 weeks PMA|Safety Population|||Participants|||Count of Participants
2570478|NCT02528318|Secondary|Number of Participants With Nasal Continuous Positive Airway Pressure (nCPAP) Failure|Participants who required intubation for mechanical ventilation or surfactant administration were defined as having failed nCPAP|Randomization to 72 Hours Post Randomization|Intent-to-Treat Population|||Participants|||Count of Participants
2570479|NCT02528318|Secondary|Bronchopulmonary Dysplasia|Number of participants with bronchopulmonary dysplasia (BPD) and number of participants alive and without BPD at 36 weeks post-menstrual age (PMA)|Randomization to 36 weeks PMA|Intent-to-Treat Population|||Participants|||Count of Participants
2570480|NCT02528318|Secondary|Number of Participants With Worsening of Respiratory Status Criteria|Number of participants with worsening in one of 12 respiratory status criteria through 72 hours post randomization (need for additional surfactant therapy, desaturation < 80%, heart rate < 100 bpm, sustained fraction of inspired oxygen (FiO2) > 0.50, arterial carbon dioxide (PCO2) > 65 mmHg, sustained apnea, persistent arterial pH < 7.2, intubation for any reason, nCPAP > 7 cmH2O, initiation of intermittent positive pressure ventilation, death, principal investigator determination of worsening status)|Randomization to 72 Hours Post Randomization|Intent-to-Treat Population|||Participants|||Count of Participants
2570481|NCT02528318|Primary|Number of Participants With Air Leak|Number of participants with air leak (includes pneumothorax, pulmonary interstitial emphysema (PIE), pneumomediastinum, pneumopericardium, subcutaneous emphysema)|7 days|This dose-escalation study was terminated after completion of the 100 mg/kg group for administrative purposes. No participants were enrolled in the 150 mg/kg group or received 150 mg/kg.|||Participants|||Count of Participants
2570482|NCT02528318|Primary|Number of Participants With Peri-Dosing Adverse Events - Initial Dose|Number of Participants with adverse events that were experienced during the initial study treatment|Randomization to 24 Hours Post Randomization|Safety Population. Peri-dosing events are events that occur during study treatment. Since this was an open-label study, no peri-dosing events were recorded for nCPAP alone. Any adverse events that occurred during the corresponding time for nCPAP alone were recorded as adverse events but not peri-dosing events.|||Participants|||Count of Participants
2570483|NCT02528305|Primary|Executive Function (Verbal Fluency Test)|"written verbal fluency test: participant asked to write down as many English words as possible within 60 seconds, starting with a particular letter of the alphabet, excluding proper nouns or plurals.~Baseline assessment-letter A Post Control assessment -letter S After HIT assessment -letter F"|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||words||Standard Deviation|Mean
2570484|NCT02528305|Primary|Long-term Memory Recall|"testing of verbal word presentation-delayed recall of 10 words 10 minutes after words initially presented (within 60 seconds).~Maximum= 10 words, minimum = no words"|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||words||Standard Deviation|Mean
2570485|NCT02528305|Primary|Ankle Brachial Pressure Index (ABPI)|ratio of blood pressure in left arm and right ankle|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||ABPI||Standard Deviation|Mean
2571698|NCT02513732|Secondary|Number of Participants With Death,Myocardial Infarction and Revascularization(DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|During hospitalization|ITT population|||Participants|||Count of Participants
2570487|NCT02528305|Primary|Estimated VO2 Max|VO2 max estimated via submaximal exercise test-submaximal treadmill walking test Calculated via formula: VO2max= 15.1+21.8 x speed (miles per hour) - 0.327 x heart rate (beats per minute) - 0.263 x speed x age (years) + 0.00504 x heart rate x age + 5.98 x gender (0=female, 1=male)|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||millilitres/kilogram/minute||Standard Deviation|Mean
2570488|NCT02528305|Primary|Short-term Memory Recall|testing of verbal word presentation-immediate recall of 10 words (60 seconds for recall) Maximum =10, minimum =0|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||words||Standard Deviation|Mean
2570489|NCT02528305|Primary|General Well-being as Assessed by SF-36 Questionnaire|Assessment of: physical functioning, social functioning, mental health, pain, change in health, physical role limitation, mental role limitation, energy and vitality, health perception over preceding 4 weeks (other than change in health, which is a comparison to health the preceding year), expressed as a transformed score range 0-100, with a higher score indicating better function/freedom from pain etc|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||units on a scale||Standard Deviation|Mean
2570490|NCT02528305|Primary|Blood Pressure|taken with participant supine, measured on left arm|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||mmHg||Standard Deviation|Mean
2570491|NCT02528305|Primary|Body Fat Mass Estimated Via Bioimpedance|total body fat and trunk fat estimated via bioimpedance measured after overnight fast, expressed as percentage|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||percentage body fat||Standard Deviation|Mean
2570492|NCT02528305|Primary|FIB-4|"calculated from AST, ALT, platelets and participant's age and used to estimate amount of fibrosis in liver.~Fib-4 score of <1.45 has negative predictive value of 90% for advanced fibrosis."|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||Fibrosis Score||Standard Deviation|Mean
2570493|NCT02528305|Primary|AST: ALT Ratio|"ratio of liver enzymes aspartate aminotransferase (AST) to alanine aminotransferase (ALT).~used as a diagnostic aid e.g. AST:ALT of more than 2:1 is characteristic of alcoholic liver disease whereas fatty steatosis and many other causes of liver disease, ratio is less than or equal to 1.~Ratio may rise as fibrosis and cirrhosis develop in viral hepatitis."|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||ratio||Standard Deviation|Mean
2570494|NCT02528305|Primary|Oral Glucose Tolerance Test|measurement of capillary samples for glucose at time 0, followed by every 20 minutes for 2 hours following ingestion of 75g glucose. Results graphed against time, then area under the curve calculated for each of the 3 assessments.|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||mmol/L*min||Standard Deviation|Mean
2570495|NCT02528305|Primary|Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|calculation of insulin resistance via formula: fasting insulin (mIU/L) x fasting glucose (mg/dL)/405 normal insulin resistance -HOMA score <3 moderate insulin resistance -HOMA score 3-5 severe insulin resistance -HOMA score >5 Assessed at baseline, after 6 week control period and within 1 week of completing 6 weeks HIT|Baseline, Follow up at 6 Weeks and following HIT intervention at 12 Weeks||||units on a scale||Standard Deviation|Mean
2570496|NCT02528253|Secondary|Number of Participants With Anti Tanezumab Antibodies|Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA). Participants listed as having anti-tanezumab antibodies had ADA titer level >=3.32. Less than 3.32 was considered below the limit of quantitation. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.|Baseline, Weeks 8, 16, 32, 40, 48, 56, 64 and 80|The safety population was defined as all participants treated with tanezumab or placebo SC. Here, ‘n’ = participants who had at least one ADA sample for ADA assessment at specified timepoints. Data not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tanezumab after W16.|||Participants|||Count of Participants
2570497|NCT02528253|Secondary|Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80|NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis), higher score indicated higher abnormality/impairment and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent), higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80|Safety population. Data not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tanezumab after W16. ’N’ in placebo arm=participants who received only placebo for entire study. Those who were there up to W16,but switched to tanezumab after W16 are included in tanezumab 5/10mg arm.|||units on a scale||Standard Deviation|Mean
2570498|NCT02528253|Secondary|Percentage of Participants With Total Joint Replacements|Percentage of participants who underwent at least one total knee, hip or shoulder joint replacement surgery.|Baseline up to Week 80|Safety population. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms. N in placebo arm=number of participants who received only placebo for entire study, those who were there up to W16,but switched to tanezumab treatment after W16 are included in tanezumab 5/10 mg arm.|||percentage of participants||95% Confidence Interval|Number
2570499|NCT02528253|Secondary|Percentage of Participants With Adjudicated Joint Safety Outcomes|Incidence of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive OA (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture.|Baseline up to Week 80|Safety population was analyzed. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms. ’N’ in placebo arm=participants who received only placebo for entire study, those who were there up to W16,but switched to tanezumab after W16 are included in tanezumab 5/10mg arm.|||percentage of participants||95% Confidence Interval|Number
2570768|NCT02525536|Primary|Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for AMG 386 After Week 4 Dose|Tmax is the time to reach the maximum serum concentration (Cmax), equal to time (hours) to Cmax.|Week 4: predose, 1, 2, 6, 24, 48, 96, 168 and 264 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.|||hr||Full Range|Median
2570500|NCT02528253|Secondary|Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80|The SAS is a 12 item (11 for females) questionnaire, from which the total number of symptoms (0-12 for males and 0-11 for females) is calculated. Each positive symptom is rated from 1 (not at all) to 5 (a lot). The total impact score was the sum of all symptom rating scores, with 0 assigned where the participant did not have the particular symptom. The range for the total impact score is 0-60 for males and 0-55 for females, higher scores indicating higher impact. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.|Screening (up to maximum of 37 days prior to Baseline), Weeks 24, 56 and 80|Safety population. Data not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tanezumab after W16. ’N’ in placebo arm=participants who received only placebo for entire study. Those who were there up to W16,but switched to tanezumab after W16 are included in tanezumab 5/10mg arm.|||units on a scale||Standard Deviation|Mean
2570501|NCT02528253|Secondary|Number of Participants With Confirmed Orthostatic Hypotension|Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: For systolic BP <=150 mmHg (mean supine): Reduction in systolic BP>=20 mmHg or reduction in diastolic BP>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP >150 mmHg (mean supine): Reduction in systolic BP>=30 mmHg or reduction in diastolic BP>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms. Data not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tanezumab after W16.|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80|Safety population analyzed. ’N’ in placebo arm=participants who received only placebo for entire study, those who were there up to W16,but switched to tanezumab after W16 are included in tanezumab 5/10mg arm. Hence, N=participants evaluable for this OM.|||Participants|||Count of Participants
2570502|NCT02528253|Secondary|Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80|Heart rate was measured at sitting position. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.|Baseline, Weeks 16, 56 and 80|Safety population. Data not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tanezumab after W16. ’N’ in placebo arm=participants who received only placebo for entire study. Those who were there up to W16,but switched to tanezumab after W16 are included in tanezumab 5/10mg arm.|||beats per minute||Standard Deviation|Mean
2570503|NCT02528253|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80|A 12-lead ECG was recorded after participants had rested for at least 5 minutes in the supine position in a quiet environment. All standard intervals {RR interval, PR interval, QRS interval, QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF)} were collected. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.|Baseline, Weeks 16, 56 and 80|Safety population. Data not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tanezumab after W16. ’N’ in placebo arm=participants who received only placebo for entire study. Those who were there up to W16,but switched to tanezumab after W16 are included in tanezumab 5/10mg arm.|||millisecond||Standard Deviation|Mean
2570504|NCT02528253|Secondary|Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80|Heart rate was measured at sitting position. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80|Safety population. Data not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tanezumab after W16. ’N’ in placebo arm=participants who received only placebo for entire study. Those who were there up to W16,but switched to tanezumab after W16 are included in tanezumab 5/10mg arm.|||beats per minute||Standard Deviation|Mean
2570505|NCT02528253|Secondary|Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80|Measurement of BP included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP). Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80|Safety population. Data not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tanezumab after W16. ’N’ in placebo arm=participants who received only placebo for entire study. Those who were there up to W16,but switched to tanezumab after W16 are included in tanezumab 5/10mg arm.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2570506|NCT02528253|Secondary|Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline|Primary Abnormality criteria: hemoglobin; hematocrit; RBC count < 0.8*LLN; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*ULN; platelets <0.5*LLN,>1.75*upper limit of normal (ULN); white blood cell count<0.6*LLN, >1.5*ULN; Lymphocytes, Leukocytes, Neutrophils <0.8*LLN, >1.2*ULN; Basophils, Eosinophils, Monocytes >1.2*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides >1.3*ULN; Urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN; Hemoglobin A1C >1.3*ULN; creatine kinase >2.0*ULN; Nitrite >=1.|Baseline up to Week 80|Safety population was analyzed.“N”=participants evaluable for this OM. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.|||Participants|||Count of Participants
2570522|NCT02528253|Secondary|Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16|In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 56. The total dosage of acetaminophen in milligrams used during the specified week were summarized. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.|Weeks 2, 4, 8, 12 and 16|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).|||milligrams||Standard Error|Least Squares Mean
2570507|NCT02528253|Secondary|Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline|Primary Abnormality criteria: HGB, hematocrit, RBC count <0.8* lower limit of normal(LLN); Ery. mean corpuscular volume/hemoglobin/ HGB concentration, RBCs distribution width <0.9*LLN, >1.1*upper limit of normal(ULN); platelets <0.5*LLN,>1.75*ULN; WBC count<0.6*LLN, >1.5*ULN; Lymphocytes,Leukocytes,Neutrophils <0.8*LLN, >1.2*ULN; Basophils,Eosinophils,Monocytes>1.2*ULN; Prothrombin time/Intl. normalized ratio>1.1*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase,alanine aminotransferase,gamma GT,LDH,alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen,creatinine,Cholesterol,triglycerides >1.3*ULN; Urate>1.2*ULN; sodium<0.95*LLN,>1.05*ULN; potassium,chloride,calcium,magnesium,bicarbonate <0.9*LLN, >1.1*ULN; phosphate<0.8*LLN, >1.2*ULN; glucose<0.6*LLN, >1.5*ULN; HGB A1C >1.3*ULN; creatine kinase>2.0*ULN, specific gravity<1.003, >1.030; pH<4.5, >8; Urine Glucose, protein,HGB,bilirubin >=1; Ketones>=1;Urine erythrocytes,Leukocytes>=20.|Baseline up to Week 80|Safety population was analyzed.“N”=participants evaluable for this OM. Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.|||Participants|||Count of Participants
2570508|NCT02528253|Secondary|Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 56|Treatment-related AE was any untoward medical occurrence attributed to study drug in participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to W56 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator. Pre-specified intent of study for summaries for the entire treatment period (up to week 56), data was summarized by 3 arms.|Baseline up to Week 56|The safety population was defined as all participants treated with tanezumab or placebo SC. Here, “Overall number of participants analyzed”=participants evaluable for this outcome measure.|||Participants|||Count of Participants
2570509|NCT02528253|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to week 80 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.|Baseline up to Week 80|Safety population analyzed.Pre-specified intent of study for safety summaries until W80 was to summarize data by 4 arms.’N’ in placebo arm=number of participants who received only placebo for entire study.Those who were there up to W16,but switched to tanezumab after W16 are included in tanezumab 5/10 mg arm. ‘N’=participants evaluable for this OM.|||Participants|||Count of Participants
2570510|NCT02528253|Secondary|Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Low Back Pain Pain?|mPRTI: self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction),participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) & participant willingness to use drug again assessment. To assess participants willingness to use drug again, participants responded using IRT on 5 point likert scale from 1-5, where, 1= yes, I would definitely want to use the same drug again, 2= I might want to use the same drug again, 3= I am not sure, 4= I might not want to use the same drug again, 5= no, I definitely would not want to use the same drug again. Higher scores indicate lesser willingness to use the investigational product. Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.|Weeks 16 and 56|ITT population. Here, “N” signifies participants evaluable for this outcome measure. Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.|||Participants|||Count of Participants
2570511|NCT02528253|Secondary|Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment?|mPRTI : self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction),participant global preference assessment (to assess previous treatment & preference to continue using investigational product) & participant willingness to use drug again assessment. To assess preference to continue using investigational product, participants responded using IRT on 5 point likert scale from 1-5, where, 1= yes, I definitely prefer drug that I am receiving now, 2= I have a slight preference for drug that I am receiving now, 3= I have no preference either way, 4= I have a slight preference for my previous treatment, 5= No, I definitely prefer my previous treatment. Higher scores indicate lesser preference to use investigational product. Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.|Weeks 16 and 56|ITT population. Here, “N” signifies participants evaluable for this outcome measure. Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.|||Participants|||Count of Participants
2570521|NCT02528253|Secondary|Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain|Low back pain HCRU assessed utilization of healthcare resources usage during last 3 months (for Baseline during the last 3 months for baseline, weeks 64 and 80, via IRT). Visits of services directly related to low back pain evaluated were: visits to primary care physician, neurologist, rheumatologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, podiatrist, nutritionist/dietitian, radiologist, home healthcare services and other practitioner. Participants might have been counted more than once under various categories.|Baseline, Weeks 64 and 80|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, ‘n’ = Participants evaluable for this OM for specified categories.|||visits||Full Range|Median
2570512|NCT02528253|Secondary|Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Low Back Pain Before Enrolling?|The mPRTI is a self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction), participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess previous treatment, participants responded for, 1=injectable prescription medicines, 2=prescription medicines taken by mouth, 3=surgery, 4=prescription medicines and surgery and 5=no treatment. Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.|Weeks 16 and 56|ITT population. Here, “N” signifies participants evaluable for this outcome measure. Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.|||Participants|||Count of Participants
2570513|NCT02528253|Secondary|Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56|TSQM v.II: self-administered 11-item validated scale that quantified participant's level of satisfaction with study medication (7 questions scored on 7-point Likert scale [1= extremely dissatisfied, 2=very dissatisfied, 3=dissatisfied, 4=somewhat satisfied, 5=satisfied, 6=very satisfied, 7=extremely satisfied]), effectiveness and side effects/tolerability (3 questions scored on 5 point Likert scale [1= extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=slightly dissatisfied, 5=not at all dissatisfied], 1 question on 2 point scale [0 =No, 1=Yes]). 11 questions of TSQM were used to calculate 4 endpoints of effectiveness, side effects, convenience and global satisfaction, each scored on a 0-100 scale with 100=best level of satisfaction. Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.|Weeks 16 and 56|ITT population. Here, “N” signifies participants evaluable for this outcome measure. Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.|||units on a scale||Standard Error|Least Squares Mean
2570514|NCT02528253|Secondary|Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain|Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was duration since quitting job due to low back pain.|Baseline, Weeks 64 and 80|ITT population. Not all participants of the ITT population had data collected at each of the time points for this outcome measure. Hence, “N” signifies only those participants who were evaluable for this OM. Additional participants apart from the ones who had responded for quitting job responded to duration since quitting job.|||years||Full Range|Median
2570515|NCT02528253|Secondary|Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain|Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of participants who quit job due to low back pain.|Baseline, Weeks 64 and 80|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, ‘n’ = Participants who were evaluable for quiting job due to low back pain.|||Participants|||Count of Participants
2570516|NCT02528253|Secondary|Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things|Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of participants who used any aids/devices for doing things. Aids such as walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices.|Baseline, Weeks 64 and 80|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, ‘n’ = Participants who were evaluable for usage of any aids/devices for doing things.|||Participants|||Count of Participants
2570517|NCT02528253|Secondary|Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain|Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of nights stayed in the hospital due to low back pain.|Baseline, Weeks 64 and 80|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Not all participants of the ITT population had data collected at each of the time points for this outcome measure. Hence, “N” signifies only those participants who were evaluable for this OM.|||nights||Full Range|Median
2570518|NCT02528253|Secondary|Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain|Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of participants who were hospitalized due to low back pain.|Baseline, Weeks 64 and 80|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, 'n'= Participants who were evaluable for hospitalization due to low back pain at specified time points.|||Participants|||Count of Participants
2570519|NCT02528253|Secondary|Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain|Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of visits to the emergency room due to low back pain.|Baseline, Weeks 64 and 80|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Not all participants of the ITT population had data collected at each of the time points for this outcome measure. Hence, “N” signifies only those participants who were evaluable for this OM.|||visits||Full Range|Median
2570520|NCT02528253|Secondary|Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain|Low back pain HCRU assessed utilization of healthcare resources during the last 3 months for baseline, weeks 64 and 80, via IRT. Domain evaluated was number of participants who visited the emergency room due to low back pain.|Baseline, Weeks 64 and 80|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, ‘n’ signifies the number of participants who had visited the emergency room at specified time points.|||Participants|||Count of Participants
2570523|NCT02528253|Secondary|Number of Days of Rescue Medication Used at Week 64|In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 56. Number of days per week the participants used the rescue medication during the 4 weeks up to and including the particular study week were summarized.|Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, ‘Overall number of participants analyzed’ signifies participants who took rescue medication.|||days||Standard Deviation|Mean
2570524|NCT02528253|Secondary|Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56|In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 56. Number of days the participants used the rescue medication during the particular study weeks were summarized. As pre specified intent of study, for analyses after week 16 where multiple imputation was used, data was reported per 3 arms. This is because participants who received placebo from Day 1 and received tanezumab 5/10 mg at week 16, received placebo for the first 16 weeks, and their data before week 16 were not be imputed into analyses after week 16.|Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, ‘Overall number of participants analyzed’ signifies participants who were evaluable for this outcome measure.|||days||Standard Error|Least Squares Mean
2570525|NCT02528253|Secondary|Number of Participants Who Took Rescue Medication During Week 64: Observed Data|In case of inadequate pain relief, after Week 24, acetaminophen/paracetamol up to 4000 mg per day up to 5 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of participants with any use of rescue medication during the 4 weeks up to and including the particular study week were summarized.|Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, ‘Overall number of participants analyzed’ signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2570526|NCT02528253|Secondary|Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64|In case of inadequate pain relief, acetaminophen/paracetamol caplets, tablets, or capsules up to 3000 mg per day up to 3 days in a week could be taken as rescue medication between day 1 and week 56. Number of participants with any use of rescue medication during the particular study week were summarized. As pre specified intent of study, for analyses after week 16 where multiple imputation was used, data was reported per 3 arms. This is because participants who received placebo from Day 1 and received tanezumab 5/10 mg at week 16, received placebo for the first 16 weeks, and their data before week 16 were not be imputed into analyses after week 16.|Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here,”N”=participants evaluable for this OM and “n” participants evaluable for OM at specified time points.|||Participants|||Count of Participants
2570527|NCT02528253|Secondary|Time to Discontinuation Due to Lack of Efficacy|Time to discontinuation due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy.|Baseline up to Week 56|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).|||days||Full Range|Median
2570528|NCT02528253|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy|Number of participants who withdrew from treatment due to lack of efficacy have been reported here.|Baseline up to Week 56|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).|||Participants|||Count of Participants
2570529|NCT02528253|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Weeks 16, 56 and 64|WPAI: LBP is 6-question participant rated questionnaire that measures the effect of participant's chronic low back pain (CLBP) on general health and symptom severity on work productivity and regular activities. It yields 4 sub-scores: work time missed due to pain (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.|Baseline, Weeks 16, 56 and 64|ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.|||units on a scale||Standard Error|Least Squares Mean
2570530|NCT02528253|Secondary|Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data|WPAI: LBP is 6-question participant rated questionnaire that measures the effect of participant's chronic low back pain (CLBP) on general health and symptom severity on work productivity and regular activities. It yields 4 sub-scores: work time missed due to pain (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. Pre-specified intent of study for efficacy data up to Week 16 was to analyze, participants who received placebo from Day 1 and received tanezumab 5/10 mg at week 16 in placebo arm, in pooled manner. Hence data have been reported per four arms.|Baseline|ITT population was analyzed.‘n’ = Participants evaluable for this OM for specified categories. Pre-specified intent of study was w compare tanezumab Vs placebo for data up to and including week 16 and comparisons of tanezumab Vs tramadol for data up to and including week 56. Number analyzed is 0 for placebo arm for week 16 and onwards.|||units on a scale||Standard Deviation|Mean
2571079|NCT02520310|Secondary|Forward Stroke Volume (FSV)|Defined as the volume of blood pumped from the left ventricle per heartbeat.|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||ml||Standard Deviation|Mean
2570531|NCT02528253|Secondary|European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value|EQ-5D-5L: standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score.EQ-5D-5L consists of 2 components: a health state profile and an optional VAS.EQ-5D health state profile comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.Individual dimension scores ranged from 1.0(least impairment of health state) to 5.0(most impairment of health state). Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems.Responses from five domains were used to calculate a single utility index (Overall health utility score) where values are less than equal to (<=) 1.Overall health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and reduced where participant reports greater levels of problems across five dimensions.|Baseline, Weeks 8, 16, 24, 40, 56 and 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, ‘n’ = Participants evaluable for this OM at specified time points.|||units on a scale||Standard Deviation|Mean
2570532|NCT02528253|Secondary|European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score|EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Individual dimension scores ranged from 1.0 (least impairment of health state) to 5.0 (most impairment of health state). Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a participant reports greater levels of problems across the five dimensions.|Baseline, Weeks 8, 16, 24, 40 and 56|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, ‘n’ = Participants evaluable for this OM for specified categories.|||units on a scale||Standard Deviation|Mean
2570533|NCT02528253|Secondary|Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Low Back Pain From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/ Last Observation CF (LOCF)|PGA of LBP assessed by asking question to participants:Considering all ways your low back pain affects you,how are you doing today? They responded on 5 point Likert scale ranging from 1-5, using IRT, where 1=very good (asymptomatic & no limitation of normal activities);2=good (mild symptoms and no limitation of normal activities);3=fair (moderate symptoms and limitation of some normal activities);4=poor (severe symptoms & inability to carry out most normal activities); & 5=very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicated worsening of condition. % of participants with improvement of at least 2 points from baseline in PGA of LBP were reported. Missing data was imputed using BOCF/LOCF. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|ITT population.Data were not collected after W16 in placebo arm for this OM, as those who met criteria to continue, switched to active treatment with tan after W16. N =participants evaluable for this OM. intent of study was to compare tan Vs placebo for data up to & including W16 & comparisons of tan Vs tramadol for data up to & including W56.|||percentage of participants|||Number
2570534|NCT02528253|Secondary|Number of Participants Who Responded for Chronic Low Back Pain Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|Chronic Low Back Pain Responder Index analysis is a composite endpoint of average low back pain intensity (aLBPI) score, PGA of Low Back Pain, and RMDQ total score. Participants were successful responders if they had: >=30 percent reduction in mean daily average LBPI from baseline to particular week; decrease of >=30 percent in PGA of low back pain from baseline to particular week or no worsening (increase) in RMDQ total score from baseline to particular week. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms. Also, intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.|Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16. N =participants evaluable for this OM.|||Participants|||Count of Participants
2570535|NCT02528253|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Week 64: Observed Data|BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.|Baseline, Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, ‘n’ = participants evaluable for this OM at specified time point.|||units on a scale||Standard Deviation|Mean
2570586|NCT02528188|Secondary|Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 80 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.|Baseline up to Week 80|Safety population included all participants treated with tanezumab or placebo SC.|||Participants|||Count of Participants
2570536|NCT02528253|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data|BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.|||units on a scale||Standard Error|Least Squares Mean
2570537|NCT02528253|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Week 64: Observed Data|BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.|Baseline, Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, ‘n’ = participants evaluable for this OM at specified time point.|||units on a scale||Standard Deviation|Mean
2570538|NCT02528253|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data|BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.|||units on a scale||Standard Error|Least Squares Mean
2570539|NCT02528253|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Week 64: Observed Data|BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.|Baseline, Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, ‘n’ = participants evaluable for this OM at specified time point.|||units on a scale||Standard Deviation|Mean
2570540|NCT02528253|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data|BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.|||units on a scale||Standard Error|Least Squares Mean
2570602|NCT02528188|Secondary|Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16|In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in milligrams used during the specified week were summarized.|Weeks 2, 4, 8 and 16|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).|||milligrams||Standard Error|Least Squares Mean
2570541|NCT02528253|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Week 64: Observed Data|BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.|Baseline, Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, ‘n’ = participants evaluable for this OM at specified time point.|||units on a scale||Standard Deviation|Mean
2570542|NCT02528253|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data|BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.|||units on a scale||Standard Error|Least Squares Mean
2570543|NCT02528253|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Week 64: Observed Data|BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.|Baseline, Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, ‘n’ = participants evaluable for this OM at specified time point.|||units on a scale||Standard Deviation|Mean
2570544|NCT02528253|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data|BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4. Question 5 (7-items) assessed level of pain interference on daily activities. Pain interference index was calculated as the mean of the seven BPI-sf pain interference items (question 5a to g), being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point NRS with score ranging from 0 (does not interfere) to 10 (completely interferes), lower scores indicated less pain or pain interference.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.|||units on a scale||Standard Error|Least Squares Mean
2570545|NCT02528253|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Average Pain at Week 64: Observed Data|"BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4 of pain at its 'worst', 'least', 'average' and 'right now'. For the Average Pain item of the BPI-sf scale (11 point NRS scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), participants were asked to rate their pain by marking an X in one of the boxes that best described their pain during 24 hours prior to evaluation, higher scores indicated greater pain severity. Question 5 (7-items) assessed level of pain interference on daily activities."|Baseline, Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, ‘number analyzed’ = participants evaluable for this OM at specified time point.|||units on a scale||Standard Deviation|Mean
2570564|NCT02528214|Other Pre-specified|Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Week 12 and Week 24|EQ-5D-5L is a standardized health-related quality of life questionnaire developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable).|Baseline, Week 12 and Week 24|Analysis was performed on ITT population. Here, number analyzed = participants with available data for specified categories|||score on a scale||Standard Deviation|Median
2570546|NCT02528253|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Scores Average Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data|"BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4 of pain at its 'worst', 'least', 'average' and 'right now'. For the Average Pain item of the BPI-sf scale (11 point NRS scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), participants were asked to rate their pain by marking an X in one of the boxes that best described their pain during 24 hours prior to evaluation, higher scores indicated greater pain severity. Question 5 (7-items) assessed level of pain interference on daily activities.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms."|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.|||units on a scale||Standard Error|Least Squares Mean
2570547|NCT02528253|Secondary|Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Worst Pain at Week 64: Observed Data|"BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4 of pain at its 'worst', 'least', 'average' and 'right now'. For the Worst Pain item of the BPI-sf scale (11 point NRS scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), participants were asked to rate their pain by marking an X in one of the boxes that best described their pain at its worst, during 24 hours prior to evaluation, higher scores indicated greater pain severity. Question 5 (7-items) assessed level of pain interference on daily activities."|Baseline, Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, ‘n’ = participants evaluable for this OM at specified time points.|||units on a scale||Standard Deviation|Mean
2570548|NCT02528253|Secondary|Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|"BPI-sf is a self-administered questionnaire developed to assess the severity of pain and pain interference on daily functions during 24 hours prior to evaluation. Severity of pain was measured based on questions 1 to 4 of pain at its 'worst', 'least', 'average' and 'right now'. For the Worst Pain item of the BPI-sf scale (11 point NRS scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), participants were asked to rate their pain by marking an X in one of the boxes that best described their pain at its worst, during 24 hours prior to evaluation, higher scores indicated greater pain severity. Question 5 (7-items) assessed level of pain interference on daily activities.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms."|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.|||units on a scale||Standard Error|Least Squares Mean
2570549|NCT02528253|Secondary|Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56|The RMDQ is a self-administered, widely used health status measure index of how well participants with LBP are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The total score of the RMDQ is the total number of items checked ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability. Percentage of participants with cumulative reduction (as percent) (>0 %; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 %, 90% and =100 %) in RMDQ from Baseline to weeks 16, 24 and 56 were reported, participants (%) are reported more than once in categories specified.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.|Baseline, Weeks 16, 24 and 56|ITT population.Data were not collected after W16 in placebo arm for this OM,as those who met criteria to continue,switched to active treatment with tanezumab(tan) after W16.N=participants evaluable for this OM.Intent of study was to compare tan V placebo for data up to & including W16 & comparisons of tan Vs tramadol for data up to & including W56.|||percentage of participants|||Number
2570550|NCT02528253|Secondary|Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)|RMDQ: health status measure index of how well participants with LBP are able to function with regard to daily activities. Measures pain and function using 24 items describing limitations to everyday life. Total score of RMDQ is total number of items checked ranging from 0=no disability to 24=maximum disability, higher scores=greater disability. Percentage of participants with reduction in LBPI of at least (>=) 30, 50, 70 and 90% at specified weeks compared to baseline were classified as responders to LBPI and are reported here. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms. Also, intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16. N =participants evaluable for this OM.|||percentage of participants|||Number
2570603|NCT02528188|Secondary|Number of Days of Rescue Medication Used During Week 64|In case of inadequate pain relief, after week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of days the participants used the rescue medication during Week 64 were summarized.|Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here ‘Overall number of participants analyzed’ = participants who took rescue medication.|||days||Standard Deviation|Mean
2570551|NCT02528253|Secondary|Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)|Average LBP was assessed on an 11-point NRS captured through an IRT. The LBPI score was captured once a week for week 64. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with reduction in LBPI of at least (>=) 30%, 50%, 70% and 90% at weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56 compared to baseline were classified as responders to LBPI and are reported here, participants (%) are reported more than once in categories specified.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.Also, intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.|Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56|ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16. N=participants evaluable for this OM.|||percentage of participants|||Number
2570552|NCT02528253|Secondary|Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)|Average LBP was assessed on an 11-point NRS captured through an IRT. LBPI score was captured once a week for week 64. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.Percentage of participants with cumulative reduction (as percent) (greater than [>] 0%; >= 10, 20, 30, 40, 50, 60, 70, 80, 90 and equals to [=] 100 %) in LBPI from baseline to weeks 16, 24 and 56 were reported, participants (%) are reported more than once in categories specified.Missing data was imputed using mixed BOCF/LOCF.Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.Also, intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.|Baseline, Weeks 16, 24 and 56|ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16. Overall Number of Participants analyzed(N)=participants evaluable for this outcome measure (OM).|||percentage of participants|||Number
2570553|NCT02528253|Secondary|Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Week 64: Observed Data|"PGA of LBP was assessed by asking a question to participants: Considering all the ways your low back pain affects you, how are you doing today? Participants responded on a 5 point Likert scale ranging from 1-5, using IRT, where 1=very good (asymptomatic and no limitation of normal activities); 2=good (mild symptoms and no limitation of normal activities); 3=fair (moderate symptoms and limitation of some normal activities); 4=poor (severe symptoms and inability to carry out most normal activities); and 5=very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicated worsening of condition."|Baseline, Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, ‘Number analyzed’ = participants evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
2570554|NCT02528253|Secondary|Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|"PGA of LBP was assessed by asking a question to participants: Considering all the ways your low back pain affects you, how are you doing today? Participants responded on a 5 point Likert scale ranging from 1-5, using IRT, where 1=very good (asymptomatic and no limitation of normal activities); 2=good (mild symptoms and no limitation of normal activities); 3=fair (moderate symptoms and limitation of some normal activities); 4=poor (severe symptoms and inability to carry out most normal activities); and 5=very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicated worsening of condition. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms."|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.|||units on a scale||Standard Error|Least Squares Mean
2570555|NCT02528253|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data|The RMDQ is a self-administered, widely used health status measure index of how well participants with LBP are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The total score of the RMDQ is the total number of items checked ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability.|Baseline, Weeks 64 and 80|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, ‘number analyzed’ = participants evaluable for this outcome measure at specified time points.|||units on a scale||Standard Deviation|Mean
2570565|NCT02528214|Other Pre-specified|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12 and Week 24|AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that were most important to participants with asthma. AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item was scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire were averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.|Baseline, Week 12 and Week 24|Analysis was performed on ITT population. Here, number analyzed = participants with available data for specified categories.|||score on a scale||Standard Deviation|Mean
2571783|NCT02513719|Secondary|Number of Participants With All Death/All MI/All Revascularization||0 to 1 year|ITT population.|||Participants|||Count of Participants
2570556|NCT02528253|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Total Score at Weeks 2, 4, 8, 16 (for Tanezumab vs Tramadol) 24, 32, 40, 48 and 56|The RMDQ is a self-administered, widely used health status measure index of how well participants with LBP are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The total score of the RMDQ is the total number of items checked ranging from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.|||units on a scale||Standard Error|Least Squares Mean
2570557|NCT02528253|Secondary|Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64|Average LBP was assessed on an 11-point NRS captured through an IRT. The LBPI score was captured once a week for week 64. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.|Baseline, Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). ‘Number analyzed’ (n)= participants evaluable for this outcome measure (OM) at specified time point.|||units on a scale||Standard Deviation|Mean
2570558|NCT02528253|Secondary|Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56|Average LBP was assessed on an 11-point NRS captured through an IRT. The LBPI score was captured once daily from baseline up to week 16, and once weekly from week 16 to week 64. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.|Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56|ITT population.Data were not collected after W16 in placebo arm for this outcome measure, as those who met criteria to continue, switched to active treatment with tanezumab after W16.Pre-specified intent of study was to compare tanezumab Vs placebo for data up to & including W16 & comparisons of tanezumab Vs tramadol for data up to & including W56.|||units on a scale||Standard Error|Least Squares Mean
2570559|NCT02528253|Secondary|Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Tramadol at Week 16|Average LBP was assessed on an 11-point NRS captured through an IRT. Participants described their average LBP during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.|Baseline, Week 16|ITT population:randomized participants who received at least 1 dose of SC study medication(either tanezumab or matching placebo).Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.|||units on a scale||Standard Error|Least Squares Mean
2570560|NCT02528253|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) at Week 16 for Tanezumab Versus (Vs) Placebo|The RMDQ is a self-administered, widely used health status measure index of how well participants with low back pain (LBP) are able to function with regard to daily activities. It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The total score of the RMDQ from the total number of items checked ranged from 0 (no disability) to 24 (maximum disability), where higher scores indicated greater disability.|Baseline, Week 16|ITT population:randomized participants who received at least 1 dose of SC study medication(either tanezumab or matching placebo).Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.|||units on a scale||Standard Error|Least Squares Mean
2570561|NCT02528253|Primary|Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16|Average low back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive response technology (IRT). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.|Baseline, Week 16|ITT population:randomized participants who received at least 1 dose of SC study medication(either tanezumab or matching placebo).Pre-specified intent of study for efficacy data up to W16 was to analyze participants who received placebo from Day1 and then received tanezumab 5/10 mg at W16,together,in placebo arm.Data has been reported per four arms.|||units on a scale||Standard Error|Least Squares Mean
2570562|NCT02528214|Other Pre-specified|Change From Baseline in Sino Nasal Outcome Test-22 (SNOT-22) Global Score at Week 12 and Week 24|The SNOT-22 is a validated measure of health related quality of life in sino nasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life.|Baseline, Week 12 and Week 24|Analysis was performed on ITT population with bilateral nasal polyposis/chronic rhinosinusitis. Here, number analyzed = participants with available data for specified categories.|||score on a scale||Standard Deviation|Mean
2570563|NCT02528214|Other Pre-specified|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 12 and Week 24|The HADS is a general scale to detect states of anxiety and depression already used and validated in asthma, which includes HADS-A and HADS-D subscales. The instrument is comprised of 14 items: 7 related to anxiety (HADS-A) and 7 to depression (HADS-D). Each item on the questionnaire is scored from 0-3. And, the total score is the sum of the scores of the 14 items ranging from 0 (no symptoms) to 42 (severe symptoms), with higher scores indicating higher anxiety/depression complains.|Baseline, Week 12 and Week 24|Analysis was performed on ITT population. Here, number analyzed = participants with available data for specified categories.|||score on a scale||Standard Deviation|Mean
2571784|NCT02513719|Secondary|Number of Participants With All Death/All MI/All Revascularization||0 to 8 months|ITT population.|||Participants|||Count of Participants
2570566|NCT02528214|Other Pre-specified|Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Score at Weeks 2, 4, 8, 12, 16, 20, and 24|The ACQ-5 has 5 questions, reflecting top-scoring 5 asthma symptoms: woken at night by symptoms, wake in mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during previous week and to respond to each of 5 symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.|Baseline and at Weeks 2, 4, 8, 12, 16, 20, and 24|Analysis was performed on ITT population. Here, number analyzed = participants with available data for specified categories.|||score on a scale||Standard Deviation|Mean
2570567|NCT02528214|Other Pre-specified|Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Weeks 12 and 24|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12 and Week 24|Analysis was performed on ITT population. Here, “number analyzed”= participants with available data for specified categories.|||liter||Standard Deviation|Mean
2570568|NCT02528214|Other Pre-specified|Annualized Rate of Severe Exacerbation Events During The 24-Week Treatment Period|A severe asthma exacerbation event was defined as a deterioration of asthma during the 24-week treatment period requiring: use of systemic corticosteroids for >=3 days (at least double the dose currently used); and/or hospitalization related to asthma symptoms or emergency room visit because of asthma requiring intervention with a systemic corticosteroid treatment. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 24|Analysis was performed ITT population.|||Exacerbation per participant-year||95% Confidence Interval|Number
2570569|NCT02528214|Secondary|Absolute Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control|Absolute reduction was calculated by subtracting Week 24 value from baseline value.|Baseline and Week 24|"Analysis was performed on ITT population but not included in the hierarchical testing procedure. Here, number analyzed= participants with available data for specified categories."|||mg/day||Standard Deviation|Mean
2570570|NCT02528214|Secondary|Percentage of Participants Who No Longer Required Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control|Participants were classified according to the binary status of whether or not the participant still required OCS at Week 24 while maintaining asthma control.|Week 24|Analysis was performed on ITT population with baseline OCS dose less than or equal to 30 mg/day.|||percentage of participants|||Number
2570571|NCT02528214|Secondary|Percentage of Participants Achieving Maximum Possible Reduction in Oral Corticosteroids Dose Per Protocol at Week 24 While Maintaining Asthma Control|For all participants except those with baseline OCS dose at 35 mg/day, the maximum possible reduction corresponds to reduction to 0 mg/day (no longer requiring OCS). For participants starting with 35 mg/day at baseline, the maximum possible reduction is 32.5 mg/day (i.e. minimum dose per protocol is 2.5 mg).|Week 24|Analysis was performed on ITT population.|||percentage of participants|||Number
2570572|NCT02528214|Secondary|Percentage of Participants Achieving a Reduction in Oral Corticosteroids Dose to <5 mg/Day at Week 24 While Maintaining Asthma Control|Participants were classified according to the binary status of whether or not the reduction of OCS dose to <5 mg/day was achieved at Week 24.|Week 24|Analysis was performed on ITT population.|||percentage of participants|||Number
2570573|NCT02528214|Secondary|Percentage of Participants Achieving >= 50% Reduction in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control|Participants were classified according to the binary status of whether or not the 50% OCS dose reduction criterion was achieved at week 24.|Week 24|Analysis was performed on ITT population.|||percentage of participants|||Number
2570574|NCT02528214|Primary|Supplementary Presentation of Primary Outcome Measure Data: Median Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control|The Primary Outcome Measure (Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control) is summarized above, as LS Mean (SE). Table below provides a supplementary presentation of the Primary Outcome Measure data; result is presented as median (inter-quartile range). Percentage reduction of OCS dose was calculated as (optimized OCS dose [mg/day] at baseline - final OCS dose at Week 24)/optimized OCS dose at baseline x 100.|Baseline, Week 24|Analysis population included ITT patients with available data.|||percentage reduction from baseline||Inter-Quartile Range|Median
2570575|NCT02528214|Primary|Percentage Reduction From Baseline in Oral Corticosteroids (OCS) Dose at Week 24 While Maintaining Asthma Control|Percentage reduction of OCS dose was calculated as (optimized OCS dose [mg/day] at baseline - final OCS dose at Week 24)/optimized OCS dose at baseline x 100. Result is presented as Least Squares Mean (Standard Error) percentage reduction from baseline derived from ANCOVA model with missing data multiply imputed.|Baseline, Week 24|Analysis was performed on intent-to-treat (ITT) population which included randomized population analysed according to the treatment group allocated by randomization regardless of whether the treatment kit was used or not.|||Percentage reduction from baseline||Standard Error|Least Squares Mean
2570576|NCT02528188|Secondary|Number of Participants With Anti-Tanezumab Antibodies|Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA).|Baseline, Weeks 8, 16, 32, 48, 56, 64 and 80|Safety population included all participants treated with tanezumab or placebo SC. Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||Participants|||Count of Participants
2570577|NCT02528188|Secondary|Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80|NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis), higher score indicated higher abnormality/impairment and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent), higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment.|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80|Safety population included all participants treated with tanezumab or placebo SC. ‘Overall number of participants analyzed’=participants evaluable for this outcome measure. Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2570578|NCT02528188|Secondary|Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80|The SAS is a 12 item (11 for females) questionnaire, from which the total number of symptoms (0-12 for males and 0-11 for females) is calculated. Each positive symptom is rated from 1 (not at all) to 5 (a lot). The total impact score was the sum of all symptom rating scores, with 0 assigned where the participant did not have the particular symptom. The range for the total impact score is 0-60 for males and 0-55 for females, higher scores indicating higher impact.|Baseline, Weeks 24, 56 and 80|Safety population included all participants treated with tanezumab or placebo SC. ‘Overall number of participants analyzed’=participants evaluable for this outcome measure. Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2570579|NCT02528188|Secondary|Number of Participants With Confirmed Orthostatic Hypotension|Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: For systolic BP <=150 mmHg (mean supine): Reduction in systolic BP>=20 mmHg or reduction in diastolic BP>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP >150 mmHg (mean supine): Reduction in systolic BP>=30 mmHg or reduction in diastolic BP>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed.|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80|Safety population included all participants treated with tanezumab or placebo SC. ‘Overall number of participants analyzed’=participants evaluable for this outcome measure. Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||Participants|||Count of Participants
2570580|NCT02528188|Secondary|Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80|Heart rate was measured at sitting position.|Baseline, Weeks 56 and 80|Safety population included all participants treated with tanezumab or placebo SC. ‘Overall number of participants analyzed’=participants evaluable for this outcome measure. Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||beats per minute||Standard Deviation|Mean
2570581|NCT02528188|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80|A 12-lead ECG was recorded after participants had rested for at least 5 minutes in the supine position in a quiet environment. All standard intervals (PR, QRS, QT, QTcF, QTcB, RR intervals) were collected. ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (>) 30 millisecond (ms) or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR) : absolute value <=50 bpm and decrease from baseline >=20 bpm; absolute value >=120 beats per minute (bpm) and increase from baseline >=20 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS interval: absolute value >= 120 ms.|Baseline, Weeks 56 and 80|Safety population included all participants treated with tanezumab or placebo SC. ‘Overall number of participants analyzed’=participants evaluable for this outcome measure. Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||milliseconds||Standard Deviation|Mean
2570582|NCT02528188|Secondary|Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80|Heart rate (pulse rate) was measured at sitting position.|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80|Safety population included all participants treated with tanezumab or placebo SC. Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||beats per minute||Standard Deviation|Mean
2570583|NCT02528188|Secondary|Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80|Measurement of BP included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP).|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80|Safety population included all participants treated with tanezumab or placebo SC. Here, “Number analyzed” signifies those participants who were evaluable for this outcome measure for specified categories.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2570584|NCT02528188|Secondary|Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline|Primary Abnormality criteria: hemoglobin; hematocrit; RBC count < 0.8*LLN; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*ULN; platelets <0.5*LLN,>1.75*upper limit of normal (ULN); white blood cell count<0.6*LLN, >1.5*ULN; Lymphocytes, Lymphocytes/Leukocytes, Neutrophils, Neutrophils/Leukocytes <0.8*LLN, >1.2*ULN; Basophils, Eosinophils, Monocytes >1.2*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides >1.3*ULN; Urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN; Hemoglobin A1C >1.3*ULN; creatine kinase >2.0*ULN; specific gravity<1.003, >1.030; Urine erythrocytes,Leukocytes>=20; Hyaline Casts>=1.|Baseline up to Week 80|Safety population included all participants treated with tanezumab or placebo SC. Here ‘Overall number of participants analyzed’ = participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2570585|NCT02528188|Secondary|Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline|Primary Abnormality criteria: HGB, hematocrit, RBC count <0.8* lower limit of normal(LLN); Ery. mean corpuscular volume/hemoglobin/ HGB concentration, RBCs distribution width <0.9*LLN, >1.1*upper limit of normal(ULN); platelets <0.5*LLN,>1.75*ULN; Leukocytes <0.6*LLN, >1.5*ULN; Lymphocytes, Neutrophils <0.8*LLN, >1.2*ULN; Basophils,Eosinophils,Monocytes>1.2*ULN; Prothrombin time/Intl. normalized ratio>1.1*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase,alanine aminotransferase,gamma GT,LDH,alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen,creatinine,Cholesterol,triglycerides >1.3*ULN; Urate>1.2*ULN; sodium<0.95*LLN,>1.05*ULN; potassium,chloride,calcium,magnesium,bicarbonate <0.9*LLN, >1.1*ULN; phosphate<0.8*LLN, >1.2*ULN; glucose<0.6*LLN, >1.5*ULN; HGB A1C >1.3*ULN; creatine kinase>2.0*ULN, specific gravity<1.003, >1.030; pH<4.5, >8;Urine erythrocytes,Leukocytes>=20.|Baseline up to Week 80|Safety population included all participants treated with tanezumab or placebo SC. Here ‘Overall number of participants analyzed’ = participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2573863|NCT02489357|Other Pre-specified|Expression of PD-1|Number of participants with PD-1 expression in tumor tissue.|Baseline|1 participant refused biopsy. Only 2/11 samples were evaluable for this outcome measure.|||Participants|||Count of Participants
2570587|NCT02528188|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 80 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious AEs. Clinically significant physical examination abnormalities were reported as AEs.|Baseline up to Week 80|Safety population included all participants treated with tanezumab or placebo SC.|||Participants|||Count of Participants
2570588|NCT02528188|Secondary|Change From Baseline in Average Daily Step Count at Weeks 16 and 56|Average daily step count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).|Baseline, Weeks 16 and 56|Accelerometry analysis set = All participants treated with tanezumab or matching placebo SC who had any baseline or post-baseline accelerometry data. ‘Overall number of participants analyzed’=participants evaluable for this outcome measure. Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||step count||Full Range|Median
2570589|NCT02528188|Secondary|Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56|"An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - <1,500 counts) moderate (1,500 - <6,500 counts), and vigorous (>=6,500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).A bout of moderate to vigorous activity was defined as 10 or more consecutive minutes above the moderate physical activity level threshold, with allowance for interruptions of 1 or 2 minutes below the threshold."|Baseline, Weeks 16 and 56|Accelerometry analysis set = All participants treated with tanezumab or matching placebo SC who had any baseline or post-baseline accelerometry data. ‘Overall number of participants analyzed’=participants evaluable for this outcome measure. Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||minutes||Full Range|Median
2570590|NCT02528188|Secondary|Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56|An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - less than {<1500} counts moderate (1,500 - <6500 counts), and vigorous (>=6500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).|Baseline, Weeks 16 and 56|Accelerometry analysis set = All participants treated with tanezumab or matching placebo SC who had any baseline or post-baseline accelerometry data. ‘Overall number of participants analyzed’=participants evaluable for this outcome measure. Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||minutes||Full Range|Median
2570591|NCT02528188|Secondary|Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56|An average daily physical activity count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).|Baseline, Weeks 16 and 56|Accelerometry analysis set = All participants treated with tanezumab or matching placebo SC who had any baseline or post-baseline accelerometry data. ‘Overall number of participants analyzed’=participants evaluable for this outcome measure. Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||physical activity counts||Full Range|Median
2570592|NCT02528188|Secondary|Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56|Participant activity level was assessed using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).|Baseline, Weeks 16 and 56|Accelerometry analysis set = All participants treated with tanezumab or matching placebo SC who had any baseline or post-baseline accelerometry data. ‘Overall number of participants analyzed’=participants evaluable for this outcome measure. Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||minutes||Full Range|Median
2570604|NCT02528188|Secondary|Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|In case of inadequate pain relief during the treatment period, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of days the participants used the rescue medication during the particular study weeks were summarized.|Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).|||days||Standard Error|Least Squares Mean
2570605|NCT02528188|Secondary|Number of Participants Who Took Rescue Medication During Week 64|In case of inadequate pain relief, after Week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of participants with any use of rescue medication during Week 64 were summarized.|Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here ‘Overall number of participants analyzed’ = participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2570593|NCT02528188|Secondary|Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80|The LEAS is a self-administered scale to assess activity level in participants having total knee arthroplasty. The LEAS scale reflected four levels of lower-extremity activity (1)housebound(unable to walk or a minimal ability to walk) (2)more ordinary walking about the house (3)walking about the community (4)walking about the community as well as substantial work or exercise. It consisted of 12 questions resulting in 18-level scale that allowed participants to select a single description that most represented his or her self-perceived activity level. The final score was simply the number of the descriptor selected by the participant as being most representative of his or her activity level. The minimum possible score was 1(entirely bedbound) and the maximum possible score was 18(currently competitive athlete). Higher score indicated increased activity. Categorical changes from baseline were reported in terms of improvement (Change >0), No change and worsening (Change less than [<] 0).|Baseline, Weeks 4, 8, 16, 24, 56 and 80|ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). Here ‘Overall number of participants analyzed’=participants evaluable for this outcome measure. Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||Participants|||Count of Participants
2570594|NCT02528188|Secondary|Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis|OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was duration since quitting job due to OA.|Baseline, Weeks 64 and 80|ITT population was analyzed. One additional participant apart from the ones who had responded for quitting job responded to duration since quitting job. Here ‘Overall number of participants analyzed’=participants evaluable for this outcome measure. Here, “Number analyzed” =participants evaluable at specified time point for each arm, respectively.|||years||Full Range|Median
2570595|NCT02528188|Secondary|Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis|OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who quit job due to OA.|Baseline, Weeks 64 and 80|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here ‘Overall number of participants analyzed’=participants evaluable for this outcome measure. Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||Participants|||Count of Participants
2570596|NCT02528188|Secondary|Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis|OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who used any aids/devices for doing things. Aids such as walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices.|Baseline, Weeks 64 and 80|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||Participants|||Count of Participants
2570597|NCT02528188|Secondary|Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis|OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of nights stayed in the hospital due to OA.|Baseline, Weeks 64 and 80|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here ‘Overall number of participants analyzed’=participants evaluable for this outcome measure. Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||nights||Full Range|Median
2570598|NCT02528188|Secondary|Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis|OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who were hospitalized due to OA.|Baseline, Weeks 64 and 80|ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||Participants|||Count of Participants
2570599|NCT02528188|Secondary|Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis|Osteoarthritis HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of visits to the emergency room due to OA.|Baseline, Weeks 64 and 80|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here ‘Overall number of participants analyzed’=participants evaluable for this outcome measure. Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||visits||Full Range|Median
2570600|NCT02528188|Secondary|Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis|OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who visited the emergency room due to OA.|Baseline, Weeks 64 and 80|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||Participants|||Count of Participants
2570601|NCT02528188|Secondary|Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis|OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Visits of services directly related to OA evaluated were: visits to primary care physician, neurologist, rheumatologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, podiatrist, nutritionist/dietitian, radiologist, home healthcare services and other practitioner.|Baseline, Weeks 64 and 80|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, “Number analyzed” signifies those participants who were evaluable at specified time point for this outcome measure for each arm, respectively.|||visits||Full Range|Median
2570606|NCT02528188|Secondary|Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of participants with any use of rescue medication during the particular study week were summarized.|Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||Participants|||Count of Participants
2570607|NCT02528188|Secondary|Time to Discontinuation Due to Lack of Efficacy|Time to discontinuation due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy.|Baseline up to Week 56|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, ‘Overall number of participants analyzed’ signifies participants who discontinued from the study due to lack of efficacy.|||days||Full Range|Median
2570608|NCT02528188|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy|Number of participants who withdrew from treatment due to lack of efficacy have been reported here.|Baseline up to Week 56|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).|||Participants|||Count of Participants
2570609|NCT02528188|Secondary|Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use the Same Drug That You Have Received in This Study for Your Osteoarthritis Pain?|The mPRTI is a self-administered questionnaire containing participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess participant willingness to use drug again, participants responded using IRT on a 5 point likert scale from 1-5, where, 1= yes, I would definitely want to use the same drug again, 2= I might want to use the same drug again, 3= I am not sure, 4= I might not want to use the same drug again, 5= no, I definitely would not want to use the same drug again. Higher scores indicate lesser willingness to use the investigational product. Number of participants who responded for the specified question were reported.|Weeks 16 and 56|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, “Number analyzed” = participants who were evaluable at specified time point for each arm, respectively.|||Participants|||Count of Participants
2570610|NCT02528188|Secondary|Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer the Drug That You Received in This Study to Previous Treatment?|The mPRTI is a self-administered questionnaire containing participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess preference to continue using the investigational product, participants responded using IRT on a 5 point Likert scale from 1-5, where, 1= yes, I definitely prefer the drug that I am receiving now, 2= I have a slight preference for the drug that I am receiving now, 3= I have no preference either way, 4= I have a slight preference for my previous treatment, 5= No, I definitely prefer my previous treatment. Higher scores indicate lesser preference to use the investigational product. Number of participants who responded for the specified question were reported.|Weeks 16 and 56|ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). Here, “Number analyzed” = participants who were evaluable at specified time point for each arm, respectively.|||Participants|||Count of Participants
2570611|NCT02528188|Secondary|Patient-Reported Treatment Impact Assessment- Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving for Osteoarthritis Pain Before Enrolling?|The mPRTI is a self-administered questionnaire containing participant's global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant's willingness to use drug again assessment. To assess current or most recent treatment, participants responded for, 1=injectable prescription medicines, 2=prescription medicines taken by mouth, 3=surgery, 4=prescription medicines and surgery and 5=no treatment. Number of participants who responded for the specified question were reported.|Weeks 16 and 56|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, “Number analyzed” signifies those participants who were evaluable at specified time point for each arm, respectively.|||Participants|||Count of Participants
2570612|NCT02528188|Secondary|Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses|TSQM v.II is a self-administered 11-item validated scale that quantified participant's level of satisfaction with study medication (scored on a 7-point Likert scale [1= extremely dissatisfied, 2=very dissatisfied, 3=dissatisfied, 4=somewhat satisfied, 5=satisfied, 6=very satisfied, 7=extremely satisfied]) and dissatisfaction with side effects (3 questions scored on 5 point Likert scale [1= extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=slightly dissatisfied, 5=not at all dissatisfied] and 1 question on 2 point scale [0 =No, 1=Yes]). Participants were asked to assess their level of satisfaction taking all things into account. The 11 questions of the TSQM were used to calculate the 4 endpoints of effectiveness, side Effects, convenience and global satisfaction, each scored on a 0-100 scale with 100 being the best level of satisfaction.|Weeks 16 and 56|ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). Here ‘Overall number of participants analyzed’=participants evaluable for this outcome measure. Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Error|Least Squares Mean
2570769|NCT02525536|Primary|Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for AMG 386 After Week 1 Dose|Tmax is the time to reach the maximum serum concentration (Cmax), equal to time (hours) to Cmax.|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after end of infusion, Week 2: predose|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 1 assessment available.|||hour (hr)||Full Range|Median
2570613|NCT02528188|Secondary|European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value|EQ-5D-5L: standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D health state profile comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Responses from the five domains were used to calculate a single utility index (the Overall health utility score) where values are less than or equal to (<=) 1. The Overall health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a participant reports greater levels of problems across the five dimensions.|Baseline, Weeks 8, 16, 24, 40, 56 and 64|ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2570614|NCT02528188|Secondary|Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain|Number of participants with anxiety/ depression domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.|Baseline, Weeks 8, 16, 24, 40, 56 and 64|ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). Here, “Number analyzed” signifies those participants who were evaluable at specified time point for each arm, respectively.|||Participants|||Count of Participants
2570615|NCT02528188|Secondary|Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain|Number of participants with pain/discomfort domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.|Baseline, Weeks 8, 16, 24, 40, 56 and 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, “Number analyzed” signifies those participants who were evaluable at specified time point for each arm, respectively.|||Participants|||Count of Participants
2570616|NCT02528188|Secondary|Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain|Number of participants with usual activities domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.|Baseline, Weeks 8, 16, 24, 40, 56 and 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, “Number analyzed” signifies those participants who were evaluable at specified time point for each arm, respectively.|||Participants|||Count of Participants
2570617|NCT02528188|Secondary|Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain|Number of participants with self-care domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.|Baseline, Weeks 8, 16, 24, 40, 56 and 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, “Number analyzed” signifies those participants who were evaluable at specified time point for each arm, respectively.|||Participants|||Count of Participants
2570618|NCT02528188|Secondary|Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain|Number of participants with mobility domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.|Baseline, Weeks 8, 16, 24, 40, 56 and 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, “Number analyzed” signifies those participants who were evaluable at specified time point for each arm, respectively.|||Participants|||Count of Participants
2570812|NCT02524418|Secondary|Time to Set-up the Spyglass DS for the Procedure|The time it takes to set up the Spyglass DS and related equipment for the procedure.|approximately 2 hours|In 20 procedures, the Spyglass equipment set up was done after ERCP started and this time was recorded. The Investigators did not record the set up time for the other procedures.|||minutes||Full Range|Mean
2570619|NCT02528188|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64|WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline, Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2570620|NCT02528188|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56|WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Weeks 16, 24 and 56|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Error|Least Squares Mean
2570621|NCT02528188|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Week 64|"WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when going up or down the stairs? Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain."|Baseline, Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2570622|NCT02528188|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|"WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when going up or down the stairs? Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain."|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).|||units on a scale||Standard Error|Least Squares Mean
2570623|NCT02528188|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 64|"WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when walking on a flat surface?. Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain."|Baseline, Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2570624|NCT02528188|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|"WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: How much pain have you had when walking on a flat surface?. Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain."|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).|||units on a scale||Standard Error|Least Squares Mean
2570625|NCT02528188|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 64|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.|Baseline, Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2571080|NCT02520310|Secondary|Forward Stroke Volume (FSV)|Defined as the volume of blood pumped from the left ventricle per heartbeat.|At baseline (Within 14 days prior to the AVJ-514 procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||ml||Standard Deviation|Mean
2570626|NCT02528188|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).|||units on a scale||Standard Error|Least Squares Mean
2570627|NCT02528188|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 64|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.|Baseline, Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2570628|NCT02528188|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.|Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).|||units on a scale||Standard Error|Least Squares Mean
2570629|NCT02528188|Secondary|Change From Baseline in Average Pain Score in the Index Joint at Week 64|Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data represents averages of the values reported during the 4-week interval up to and including Week 64. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.|Baseline, Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2570630|NCT02528188|Secondary|Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56|Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data for Weeks 20 through 56 represents averages of the values reported during the 4-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.|Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).|||units on a scale||Standard Error|Least Squares Mean
2570631|NCT02528188|Secondary|Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64|"PGA of OA was assessed by asking a question from participants: Considering all the ways your OA in your knee or hip affects you, how are you doing today? Participants responded on a scale ranging from 1-5, where, 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition. Percentage of participants with improvement of at least 2 points from baseline in PGA of OA were reported. Missing data was imputed using mixed BOCF/LOCF."|Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). “Overall number of participants analyzed” = participants who were evaluable for this outcome measure. “Number analyzed”=participants who were evaluable for this outcome measure at specified time points.|||percentage of participants|||Number
2570649|NCT02528188|Secondary|Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome|Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Individual joint safety outcome included rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.|Baseline up to Week 80|Safety population included all participants treated with tanezumab or placebo SC.|||events per 1000 participant-years||95% Confidence Interval|Number
2570632|NCT02528188|Secondary|Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56|Percentage of participants with cumulative reduction (as percent) (> 0 %; >= 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% and 90%; =100%) in WOMAC physical function subscale from baseline to Weeks 16, 24 and 56 were reported. WOMAC:Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function: participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale:17-item questionnaire to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), higher scores indicate extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.|Baseline, Weeks 16, 24 and 56|ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). Here ‘Overall number of participants analyzed’ = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2570633|NCT02528188|Secondary|Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64|Percentage of participants with reduction in WOMAC physical function of >=(30%,50%,70%,90%) at Weeks 2,4,8,16,24,32,40,48,56 and 64 compared to baseline were classified as responders to WOMAC physical function subscale. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function:Participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee/hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.|Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64|ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). “Overall number of participants analyzed” = participants who were evaluable for this outcome measure. “Number analyzed”=participants who were evaluable for this outcome measure at specified time points.|||percentage of participants|||Number
2570634|NCT02528188|Secondary|Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56|WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than [>] 0% ; >= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in WOMAC pain subscale from Baseline to Weeks 16, 24 and 56 were reported, participants (%) are reported more than once in categories specified. Missing data was imputed using mixed BOCF/LOCF.|Baseline, Weeks 16, 24 and 56|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here ‘Overall number of participants analyzed’ = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2570635|NCT02528188|Secondary|Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64|Percentage of participants with reduction in WOMAC pain intensity of >= 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 compared to baseline were classified as responders to WOMAC pain subscale and are reported here. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Missing data was imputed using mixed BOCF/LOCF.|Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). “Number analyzed”=participants who were evaluable for this outcome measure at specified time points.|||percentage of participants|||Number
2570636|NCT02528188|Secondary|Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64|Participants were considered as OMERACT-OARSI responders: if the change (improvement) from baseline to week of interest was >=50 percent and >= 2 units in either WOMAC pain subscale or physical function subscale score; if change (improvement) from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of OA. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and PGA of OA (score: 1 [very good] to 5 [very poor], higher score = worse condition). Missing data was imputed using mixed baseline/last observation carried forward (BOCF/LOCF).|Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). “Number analyzed”=participants who were evaluable for this outcome measure at specified time points.|||percentage of participants|||Number
2571081|NCT02520310|Secondary|Systolic Anterior Motion of the Mitral Valve (Present or Absent)||5 years|||||||
2571082|NCT02520310|Secondary|Systolic Anterior Motion of the Mitral Valve (Present or Absent)||4 years|||||||
2570637|NCT02528188|Secondary|Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 64|"PGA of OA was assessed by asking a question from participants: Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, using IRT, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition."|Baseline, Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo). Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2570638|NCT02528188|Secondary|Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56|"PGA of OA was assessed by asking a question from participants: Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, using IRT, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition."|Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).|||units on a scale||Standard Error|Least Squares Mean
2570639|NCT02528188|Secondary|Change From Baseline in WOMAC Physical Function Subscale at Week 64|WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.|Baseline, Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2570640|NCT02528188|Secondary|Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56|WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.|Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56|ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo).|||units on a scale||Standard Error|Least Squares Mean
2570641|NCT02528188|Secondary|Change From Baseline in WOMAC Pain Subscale at Week 64|WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS, which may not be a whole (integer) number. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.|Baseline, Week 64|ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo). Here, “Number analyzed” =participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2570642|NCT02528188|Secondary|Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56|WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS, which may not be a whole (integer) number. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.|Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56|ITT population included all randomized participants who received at least one dose of SC study medication (either Tanezumab or matching placebo).|||units on scale||Standard Error|Least Squares Mean
2570650|NCT02528188|Secondary|Percentage of Participants With Individual Adjudicated Joint Safety Outcome|Any participant with incidence of an adjudicated outcome of rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of JSW >=2 mm within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.|Baseline up to Week 80|Safety population included all participants treated with tanezumab or placebo SC.|||percentage of participants||95% Confidence Interval|Number
2571083|NCT02520310|Secondary|Systolic Anterior Motion of the Mitral Valve (Present or Absent)||3 years|||||||
2570643|NCT02528188|Secondary|Number of Participants With Progression of Osteoarthritis in the Index Hip (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80|Progression of OA according to Bland-Altman methodology as defined by a decrease in JSW >=1.96 times within-participant standard deviation of the change in JSW in the index hip. The number of participants with progression of OA in the index hip per Bland-Altman methodology are reported. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function.|Weeks 56 and 80|Safety population included all participants treated with tanezumab or placebo SC. Here “Overall number of participants analyzed” signifies participants who were evaluable for this outcome measure, and “Number analyzed” signifies those participants who were evaluable at specified time point for each arm, respectively.|||Participants|||Count of Participants
2570644|NCT02528188|Secondary|Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80|Progression of OA according to Bland-Altman as defined by a decrease JSW >=1.96 times within-participant standard deviation of change in JSW. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral). Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 [no radiographic features of OA], 1 [doubtful joint space narrowing (JSN) and possible osteophytic lipping], 2 [definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph], 3 [multiple osteophytes, definite JSN, sclerosis, possible bony deformity], 4 [large osteophytes, marked JSN, severe sclerosis and definite bony deformity]. Higher grade indicating worse knee function.|Weeks 56 and 80|Safety population included all participants treated with tanezumab or placebo SC. Here “Overall number of participants analyzed” signifies participants who were evaluable for this outcome measure, and “Number analyzed” signifies those participants who were evaluable at specified time point for each arm, respectively.|||Participants|||Count of Participants
2570645|NCT02528188|Secondary|Change From Baseline in Joint Space Width of the Index Hip (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80|Change from baseline in JSW was defined as narrowing in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the index hip in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function.|Baseline, Weeks 56 and 80|Safety population included all participants treated with tanezumab or placebo SC. Here “Overall number of participants analyzed” signifies participants who were evaluable for this outcome measure, and “Number analyzed” signifies those participants who were evaluable at specified time point for each arm, respectively.|||millimeter||Standard Error|Least Squares Mean
2570646|NCT02528188|Secondary|Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80|Change from baseline in JSW was defined as change in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the medial and lateral tibiofemoral of knee in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 [no radiographic features of OA], 1 [doubtful joint space narrowing (JSN) and possible osteophytic lipping], 2 [definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph], 3 [multiple osteophytes, definite JSN, sclerosis, possible bony deformity], 4 [large osteophytes, marked JSN, severe sclerosis and definite bony deformity]. Higher grade indicating worse knee function. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral).|Baseline, Weeks 56 and 80|Safety population included all participants treated with tanezumab or placebo SC. Here “Overall number of participants analyzed” signifies participants who were evaluable for this outcome measure, and “Number analyzed” signifies those participants who were evaluable at specified time point for each arm, respectively.|||millimeter||Standard Error|Least Squares Mean
2570647|NCT02528188|Secondary|Observation Time-Adjusted Event Rate of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome|Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.|Baseline up to Week 80|Safety population included all participants treated with tanezumab or placebo SC.|||events per 1000 participant-years||95% Confidence Interval|Number
2570648|NCT02528188|Secondary|Percentage of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome|Percentage of participants with total joint replacement (hip, knee or shoulder) or adjudicated primary composite joint safety outcomes were reported. Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture.|Baseline up to Week 80|Safety population included all participants treated with tanezumab or placebo SC.|||percentage of participants||95% Confidence Interval|Number
2570662|NCT02527694|Primary|Comparison of Percentage of Chest Compression Fraction Between Before- and After-phase Groups|Chest compression fraction was calculated as proportion of CPR time spent providing compressions.|During the total prehospital resuscitation time||||Percentage of chest compression fraction||Inter-Quartile Range|Median
2570809|NCT02524418|Secondary|Measurement in Minutes for Spyglass DS Therapeutic Maneuvers|The time it takes to perform the therapeutic maneuvers with the SpyGlass DS in cases sampling was attempted measured in minutes.|approximately 2 hours|For the 75 participants in the study, 83 procedures were completed. Of the 83 procedures, sampling was attempted on 37 procedures in 27 participants.|||minutes|Number of Procedures analyzed|Full Range|Mean
2570651|NCT02528188|Secondary|Observation Time-Adjusted Event Rate of Participants With Adjudicated Secondary Composite Joint Safety Outcome|Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Secondary joint safety outcome included primary osteonecrosis, rapidly progressive OA (type-2), subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.|Baseline up to Week 80|Safety population included all participants treated with tanezumab or placebo SC.|||events per 1000 participant-years||95% Confidence Interval|Number
2570652|NCT02528188|Secondary|Percentage of Participants With Adjudicated Secondary Composite Joint Safety Outcome|Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.|Baseline up to Week 80|Safety population included all participants treated with tanezumab or placebo SC.|||percentage of participants||95% Confidence Interval|Number
2570653|NCT02528188|Primary|Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16|"PGA of OA was assessed by asking a question from participants: Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today? Participants responded on a scale ranging from 1-5, using Interactive Response Technology (IRT), where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition."|Baseline, Week 16|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).|||units on a scale||Standard Error|Least Squares Mean
2570654|NCT02528188|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16|WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.|Baseline, Week 16|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).|||units on a scale||Standard Error|Least Squares Mean
2570655|NCT02528188|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16|WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions, which may not be a whole (integer) number, scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.|Baseline, Week 16|ITT population included all randomized participants who received at least one dose of SC study medication (either tanezumab or matching placebo).|||units on a scale||Standard Error|Least Squares Mean
2570656|NCT02528188|Primary|Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome|Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Primary joint safety outcome included participants with adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.|Baseline up to Week 80|Safety population included all participants treated with tanezumab or placebo SC.|||events per 1000 participant-years||95% Confidence Interval|Number
2570657|NCT02528188|Primary|Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome|Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive osteoarthritis (OA) type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of joint space width (JSW) (greater than or equal to [>=] 2 millimeters [mm]) within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.|Baseline up to Week 80|Safety population included all participants treated with tanezumab or placebo SC.|||percentage of participants||95% Confidence Interval|Number
2570658|NCT02528097|Other Pre-specified|Administration of Albumin|The amount of albumin administered to each study participant over the course of the study (time 0 through 72 hours)|Throughout Study (72 hours)|||||||
2570659|NCT02528097|Secondary|All Cause Mortality||At any point from time 0 through day 3|Outcome data was not collected due to logistical challenges of completing the study.||||||
2570660|NCT02528097|Primary|Renal Failure|Primary outcome is the presence of renal failure at any point from the start of the study (time 0) through 72 hours|At any point from time 0 through day 3|Outcome data was not collected due to logistical challenges of completing the study.||||||
2570661|NCT02527694|Secondary|CPR Duration||During total prehospital resuscitation||||seconds||Inter-Quartile Range|Median
2571084|NCT02520310|Secondary|Systolic Anterior Motion of the Mitral Valve (Present or Absent)||24 months|||||||
2570663|NCT02527434|Secondary|Median OS During Retreatment Phase|OS during the retreatment phase was defined as the time from the date of first dose until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique.|From baseline in retreatment phase to final data cut-off date|Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).|||Months||95% Confidence Interval|Median
2570664|NCT02527434|Secondary|BoR During Retreatment Phase|BoR during the retreatment phase was calculated based on the overall visit responses from each RECIST 1.1 assessment and was defined as the best response a patient had during their time in the study (from CR, PR, SD, PD or NE) obtained among all tumor assessment visits from baseline until end of treatment or determination of PD. The BoR was summarized by percentage of patients for each category (CR, PR, SD, PD, and NE).|From baseline to 12 months in retreatment phase|Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).|||Percentage of Patients|||Number
2570665|NCT02527434|Secondary|Median PFS During Retreatment Phase|"PFS during the retreatment phase was assessed by the site Investigator using RECIST 1.1 and defined as the time from the date of enrollment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from therapy or received another anticancer therapy prior to progression.~Progression events that did not occur within 3 months (PDAC patients) or 4 months (UBC/TNBC patients) of the last evaluable assessment (or first dose) were censored. Median PFS was calculated using the Kaplan-Meier technique."|From baseline to 12 months in retreatment phase|Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).|||Months||Inter-Quartile Range|Median
2570666|NCT02527434|Secondary|DCR During Retreatment Phase|DCR during the retreatment phase was defined as the percentage of patients who had a BoR of CR or PR in the first 3 months (PDAC patients) or 4 months (UBC and TNBC patients) or who had demonstrated SD for a minimum interval of 3 or 4 months following the start of study treatment. DCR was determined programmatically based on RECIST 1.1 using site Investigator data and all data up until the first progression event. 95% CIs were calculated using the Clopper Pearson method.|From baseline to 4 months in retreatment phase|Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).|||Percentage of Patients||95% Confidence Interval|Number
2570667|NCT02527434|Secondary|Median DoR During Retreatment Phase|DoR during the retreatment phase was assessed by the site Investigator using RECIST 1.1 and was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. If a patient did not progress following a response, then their DoR was censored at the PFS censoring time. DoR was not defined for those patients who did not have documented response. Median DoR was calculated using the Kaplan-Meier technique.|From baseline to 12 months in retreatment phase|Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).|||Months||Inter-Quartile Range|Median
2570668|NCT02527434|Secondary|Percentage of Patients With Confirmed Overall Response During Retreatment Phase|ORR was assessed by the site Investigator using RECIST 1.1 and was defined as the percentage of patients with a confirmed overall response of CR or PR and was based on all treated patients who had measurable disease at baseline (Day 1) and who sequenced to durvalumab monotherapy (MEDI treatment phase) or durvalumab + tremelimumab combination therapy (COMBO treatment phase). 95% CIs were calculated using the Clopper Pearson method.|From baseline to 12 months in retreatment phase|Analysis was performed on the MEDI and COMBO analysis sets (all patients who were treated with tremelimumab, received at least 1 dose of durvalumab monotherapy or durvalumab + tremelimumab combination therapy as applicable, and who had a baseline tumor assessment prior to dosing).|||Percentage of Patients||95% Confidence Interval|Number
2570669|NCT02527434|Secondary|Median Overall Survival (OS) During Tremelimumab Monotherapy Phase|"OS was defined as the time from the date of first dose until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. OS is presented from start of tremelimumab monotherapy phase and includes the retreatment phase if the patient entered the corresponding treatment phase.~Median OS was calculated using the Kaplan-Meier technique."|From baseline to final data cut-off date|Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).|||Months||95% Confidence Interval|Median
2570670|NCT02527434|Secondary|Best Objective Response (BoR) During Tremelimumab Monotherapy Phase|BoR during the initial tremelimumab monotherapy phase was calculated based on the overall visit responses from each RECIST 1.1 assessment and was defined as the best response a patient had during their time in the study (from CR, PR, SD, PD or not evaluable [NE]) obtained among all tumor assessment visits from baseline until end of treatment or determination of PD. The BoR was summarized by percentage of patients for each category (CR, PR, SD, PD, and NE).|From baseline to 12 months in the tremelimumab monotherapy phase|Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).|||Percentage of Patients|||Number
2570685|NCT02527161|Secondary|Knee Injury and Osteoarthritis Score (KOOS)|KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|12 months Post-Operatively|Participants with available data. Participants=knees.|||units on a scale||Standard Deviation|Mean
2570671|NCT02527434|Secondary|Median PFS During Tremelimumab Monotherapy Phase|PFS during the initial tremelimumab monotherapy phase was assessed by the site Investigator using RECIST 1.1 and was defined as the time from the date of enrollment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from therapy or received another anticancer therapy prior to progression. Progression events that did not occur within 3 months (PDAC patients) or 4 months (UBC/TNBC patients) of the last evaluable assessment (or first dose) were censored. Median PFS was calculated using the Kaplan-Meier technique.|From baseline to 12 months in the tremelimumab monotherapy phase|Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).|||Months||Inter-Quartile Range|Median
2570672|NCT02527434|Secondary|Disease Control Rate (DCR) During Tremelimumab Monotherapy Phase|DCR during the initial tremelimumab monotherapy phase was defined as the percentage of patients who had a best objective response (BoR) of CR or PR in the first 3 months (PDAC patients) or 4 months (UBC and TNBC patients) and 12 months (all patients), or who had demonstrated stable disease (SD) for a minimum interval of 3, 4 or 12 months following the start of study treatment. DCR was determined programmatically based on RECIST 1.1 using site Investigator data and all data up until the first progression event. 95% CIs were calculated using the Clopper Pearson method.|From baseline to 12 months in the tremelimumab monotherapy phase|Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).|||Percentage of patients||95% Confidence Interval|Number
2570673|NCT02527434|Secondary|Median Duration of Response (DoR) During Tremelimumab Monotherapy Phase|DoR during the initial tremelimumab monotherapy phase was assessed by the site Investigator using RECIST 1.1 and was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR. If a patient did not progress following a response, then their DoR was censored at the progression-free survival (PFS) censoring time. DoR was not defined for those patients who did not have documented response. Median DoR was calculated using the Kaplan-Meier technique.|From baseline to 12 months in the tremelimumab monotherapy phase|Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).|||Months||Inter-Quartile Range|Median
2570674|NCT02527434|Primary|Percentage of Patients With Confirmed Overall Response During Tremelimumab Monotherapy Phase|Objective response rate (ORR) during the initial tremelimumab monotherapy phase was assessed by the site Investigator using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) and was defined as the percentage of patients with a confirmed overall response of complete response (CR) or partial response (PR) and was based on all treated patients who had measurable disease at baseline (Day 1). 95% confidence intervals (CIs) were calculated using the Clopper Pearson method.|From baseline to 12 months in the tremelimumab monotherapy phase|Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).|||Percentage of Patients||95% Confidence Interval|Number
2570675|NCT02527161|Secondary|Pain|Measured by Visual analogue scale (VAS)|5 years Post-Operatively|||||||
2570676|NCT02527161|Secondary|Pain|Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.|2 years Post-Operatively|Participants with available data. Participants = knees. 87 knees had VAS pain during mobilization measurements and 86 knees had VAS pain at rest measurements.|||centimeters||Standard Deviation|Mean
2570677|NCT02527161|Secondary|Pain|Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.|12 months Post-Operatively|Participants with available data. Participants=knees.|||centimeters||Standard Deviation|Mean
2570678|NCT02527161|Secondary|Pain|Pain at rest and pain during mobilization was measured using a 10 centimeter Visual analogue scale (VAS). Participants are asked to indicate their level of pain with 0 being no pain and 10 being the worst pain.|6 months Post-Operatively|Participants with available data. Participants=knees.|||centimeters||Standard Deviation|Mean
2570679|NCT02527161|Secondary|Short Form-12 Item Health Survey v 2 (SF-12)||5 years Post-Operatively|||||||
2570680|NCT02527161|Secondary|Short Form-12 Item Health Survey v 2 (SF-12)|The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.|2 years Post-Operatively|Participants with available data. Participants=knees.|||units on a scale||Standard Deviation|Mean
2570681|NCT02527161|Secondary|Short Form-12 Item Health Survey v 2 (SF-12)|The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.|12 months Post-Operatively|Participants with available data. Participants=knees.|||units on a scale||Standard Deviation|Mean
2570682|NCT02527161|Secondary|Short Form-12 Item Health Survey v 2 (SF-12)|The SF-12 Health Survey is a 12 item participant completed questionnaire to measure general health and well-being. It includes a physical and mental status component score: each ranging from 0 to 100 points. Low values represent a poor health state and high values represent a good health state.|6 months Post-Operatively|Participants with available data. Participants = knees.|||units on a scale||Standard Deviation|Mean
2570683|NCT02527161|Secondary|Knee Injury and Osteoarthritis Score (KOOS)||5 years Post-Operatively|||||||
2570684|NCT02527161|Secondary|Knee Injury and Osteoarthritis Score (KOOS)|KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|2 years Post-Operatively|Participants with available data. Participants=knees.|||units on a scale||Standard Deviation|Mean
2573864|NCT02489357|Primary|Number of Participants With PSA < 0.6 ng/mL||At 1 year|Data was not collected in 1/12 participants due to lost to follow up before one year.|||Participants|||Count of Participants
2570686|NCT02527161|Secondary|Knee Injury and Osteoarthritis Score (KOOS)|KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|6 months Post-Operatively|Participants with available data. Participants=knees.|||units on a scale||Standard Deviation|Mean
2570687|NCT02527161|Secondary|Revision Rate||5 years Post-Operatively|||||||
2570688|NCT02527161|Secondary|Mechanical Alignment|AnteroPosterior Long Leg X-rays: Alignment measured to mechanical axis at zero degrees.The mechanical axis is defined by lines joining the centre of the femoral head, centre of the knee joint and the centre of the ankle. A negative value = knee varus and a positive value = knee valgus.|12 months Post-Operatively|Participants with available data. Participants=knees.|||degrees||Full Range|Mean
2570689|NCT02527161|Secondary|Forgotten Joint Score|The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).|5 years Post-Operatively|||||||
2570690|NCT02527161|Secondary|Forgotten Joint Score|The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).|2 years Post-Operatively|Participants with available data. Participants=knees.|||units on a scale||Standard Deviation|Mean
2570691|NCT02527161|Secondary|Forgotten Joint Score|The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).|12 months Post-Operatively|Participants with available data. Participants=knees|||units on a scale||Standard Deviation|Mean
2570692|NCT02527161|Primary|Knee Society Score (KSS)|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|6 months Post-Operatively|Participants with available data. Participants=knees.|||units on a scale||Standard Deviation|Mean
2570693|NCT02527161|Primary|Implant Location/Assessment of Alignment|Implant location and limb alignment is assessed using CT scan 3 months after surgery. The mean deviation of the postoperative femoral and tibial alignment from the preoperative plan is measured in degrees.|3 months Post-Operatively|Participants with available data. Participants=knees.|||degrees||Standard Deviation|Mean
2570694|NCT02527148|Secondary|Oxford Knee Score|To demonstrate, through calculation of Oxford Knee Score (OKS) post operatively, that total knee replacement (TKR) performed using the ShapeMatch® Cutting Guide provides improvement from preoperative levels of patient pain and function comparable to the improvement obtained with TKR performed using computer-assisted Navigation. Oxford Knee Scores will be calculated at 2 years and 5 years post-operatively. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome.|2 and 5 years|||||||
2570695|NCT02527148|Secondary|Perth CT Protocol|The Perth CT protocol is a comprehensive assessment of total knee replacement (TKR) component position and orientation. The alignment of the TKR components is measured against the mechanical axis and the transepicondylar axis of the lower extremity. The posted data represents the mean angle between the femoral component and mechanical axis of the femur, the angle between tibial component and mechanical axis of the tibia, the tibial component slope relative to the sagittal mechanical axis, and the femoral component rotation relative to surgical epicondylar axis (positive value=external rotation). For all degree values posted a positive (+) value= valgus and a negative (-) value = varus.|3 months|Participants=knees|||degrees||Standard Deviation|Mean
2570696|NCT02527148|Secondary|The International Knee Society Score (IKSS)|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a minimum score of 0 to a maximum of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively|||||||
2570697|NCT02527148|Secondary|The Forgotten Joint Score (FJS-12)|The Forgotten Joint Score (FJS) is a 12 question form that asks the patient their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Scores can range from 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the joint in everyday life).|6-week, 6-month,12 month visits, 2 years and 5 years|||||||
2570698|NCT02527148|Secondary|Health-related Quality of Life (EQ-5D-3L)|"The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The participant is asked to indicate his/her health state by indicating the most appropriate level for each of the 5 dimensions. Responses may be converted into a single summary index by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension. The index can be calculated by deducting the appropriate weights from 1= the value for full health.~The EQ VAS records the participant's self-rated health on a vertical, visual analogue scale where the endpoints are labelled from 100 ='Best imaginable health state' to 0= 'Worst imaginable health state'."|Preoperatively, 6-week, 6-month and 12 month visits, 2 years and 5 years|||||||
2570699|NCT02527148|Secondary|The Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC is completed by the participant and measures five items for pain (score range 0-100), two for stiffness (score range 0-100), and 17 for functional limitation (score range 0-100). The total score is the sum of these three categories.|Preoperatively, 6-week, 6-months,12 months, 2 years and 5 years postoperatively|||||||
2570701|NCT02527148|Secondary|Cost Effectiveness: Quality-adjusted Life-years (QALYs) From EQ-5D-3L|A quality-adjusted life-year (QALY) takes into account both the quantity and quality of life generated by healthcare interventions. It is the arithmetic product of life expectancy and a measure of the quality of the remaining life-years. A QALY places a weight on time in different health states. A year of perfect health is worth 1 and a year of less than perfect health is worth less than 1. Death is considered to be equivalent to 0; however,some health states may be considered worse than death and have negative scores.|12 months|"Shapematch preoperative N=49, 12 month N=48.~Navigation preoperative N=50, 12 month N-49."|||QALY life year||Standard Deviation|Mean
2570702|NCT02527148|Secondary|Cost Effectiveness: Length of Stay in Hospital|To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group the length of stay in number of days spent in the hospital is reported..|14 days||||days||Standard Deviation|Mean
2570703|NCT02527148|Secondary|Cost Effectiveness: Cost of Consumable Items Used During Operating Procedure|To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group. The data for the cost of consumable items used during the operating procedure is not available. Due to limited site resources, a decision was made not to collect this secondary outcome measure data.|Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.|Cost effectiveness data is not available.||||||
2570704|NCT02527148|Secondary|Cost Effectiveness: Wound Length|To compare the cost-effectiveness and cost-utility of the procedure between the ShapeMatch® Cutting Guide group and the computer-assisted Navigation control group the surgical incision length is reported in mm.|Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.||||millimeters||Standard Deviation|Mean
2570705|NCT02527148|Secondary|Cost Effectiveness: Total Duration of Operating Procedure (Anaesthetic Time and Skin-to-skin Incision Time)|Skin to skin time is the time in minutes from initial skin incision to skin closure. Anaesthesia time is the time in minutes that anaesthesia administration is started to the time it is stopped. Data for anaesthesia time is not available due to an error on the original case report form that did not correctly capture anaesthesia time.|Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.||||minutes||Standard Deviation|Mean
2570706|NCT02527148|Primary|Oxford Knee Score|To demonstrate, through calculation of Oxford Knee Score (OKS) post operatively, that total knee replacement (TKR) performed using the ShapeMatch® Cutting Guide provides improvement from preoperative levels of patient pain and function comparable to the improvement obtained with TKR performed using computer-assisted Navigation. Oxford Knee Scores will be calculated pre-operatively and at 6 weeks, 6 months and 12 months. The OKS is a participant completed 12 question form on activities of daily living that assess function and pain. Scores can range from 0 to 48 with lower scores indicating a poor outcome and higher scores indicating a more satisfactory joint outcome.|Preoperatively, 6-week, 6-months,and 12 months postoperatively|"Shapematch: 49 had preoperative and 6 month scores,48 had 6 week and 12 month scores.~Navigation: 50 had preoperative, and 6 month scores, 47 had 6 week, and 37 had 12 month scores~Participants=knees"|||units on a scale||Standard Deviation|Mean
2570707|NCT02526693|Primary|Maximum Constriction Asymmetry Duration|Log difference between duration of maximum pupil constriction when light is shone into the right versus the left eye. The duration of maximum constriction is calculated as time in milliseconds between point of maximum constriction and time when pupil amplitude has reached 50% of peak amplitude of dilation.|1 examination, one hour||||milliseconds||Standard Deviation|Mean
2570708|NCT02526693|Primary|Latency Asymmetry of Pupil Constriction|Pupil size changes at different speeds when light shines into the eyes making the diameter of the pupil smaller (constriction). The speed of the pupil's reaction to light is the latency or amount of time. Latency of maximum pupil constriction when light is shone is compared between the right and left eyes. Asymmetry is the difference in time it takes for maximum pupil constriction between the two eyes.|1 examination, one hour||||milliseconds||Standard Deviation|Mean
2570709|NCT02526693|Primary|Amplitude Asymmetry of Pupil Constriction|Pupil size changes when light shines into the eyes making the diameter of the pupil smaller (constriction). The size of the pupil's reaction to light, measured in millimeters, is the amplitude or change in diameter. Amplitude of maximum pupil constriction (pupil size) when light is shone is compared between the right and left eyes. Asymmetry is the difference between maximum pupil size of the two eyes.|1 examination, one hour||||millimeters||Standard Deviation|Mean
2570710|NCT02526680|Secondary|Recommending OrCam to Others|Participants were asked 'How likely would you be to recommend OrCam to another visually impaired person?' after a one month trial period with the device. Number of subjects answering Very Likely or Likely is provided.|1 month||||Participants|||Count of Participants
2570711|NCT02526680|Secondary|Impact of OrCam on Grocery Shopping|Participants were asked 'Did OrCam improve your quality of life while grocery shopping?' after a one month trial period with the device. Number of subjects answering Yes is provided.|1 month||||Participants|||Count of Participants
2570712|NCT02526680|Secondary|Impact of OrCam on Reading Newspapers|Participants were asked 'Did OrCam increase your quality of life in reading newspapers?' after a one month trial period with the device. Number of subjects answering Yes is provided.|1 month||||Participants|||Count of Participants
2570713|NCT02526680|Primary|Impact of OrCam on Vision-related Quality of Life|National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) is a series of questions pertaining to vision or feelings about a vision condition in relation to functional status to assess their quality of life. Multiple choice responses from 12 subscales (general vision, near vision, distance vision, ocular pain, social functioning, mental health, roll difficulties, dependency, driving, color vision and peripheral vision) were recorded into a 0-100 score where 0 represents the lowest perceived vision difficulties and 100 the highest perceived difficulties. NEI-VFQ-25 was used to measure the number of participants who showed improvement in vision-related quality of life after using the OrCam device over a one month period.|1 month||||Participants|||Count of Participants
2570810|NCT02524418|Secondary|Measurement in Minutes for Spyglass DS Diagnostic Maneuvers|The time it takes to perform the diagnostic maneuvers with the SpyGlass DS measured in minutes.|approximately 2 hours|83 Spyglass procedures were performed on the 75 participants|||minutes|number of Spyglass Proceudres|Full Range|Mean
2570714|NCT02526654|Secondary|Correlations Between Structure-function Automated Report and Clinical Impression|Heidelberg Edge Perimeter (HEP) Visual Field (VF) and spectral domain optical coherence tomography (SD OCT) printouts from only the glaucoma subgroup were assessed. Retinal Nerve Fiber Layer (RNFL) and Minimum Rim Width (MRW) from SD OCT and HEP VF automated reports were compared to the clinical interpretations by 3 glaucoma specialists.|Baseline visit, 1 hour|Not all eyes (automated reports) met inclusion criteria. Healthy control eye were was not included in this portion of the study. Only glaucoma subgroup received clinical interpretations by 3 glaucoma specialists.|||Kappa|eyes|95% Confidence Interval|Number
2570715|NCT02526654|Secondary|Repeatability of Optical Coherence Tomography (OCT) Parameters|A subgroup of participants were randomly selected to return at 3 and 6 months for repeat testing. Not all eyes were included. Repeatability of optical coherence tomography (OCT) to consistently detect minimum rim width (MRW) global thickness will be assessed by Pearson's interclass correlation coefficients (ICC). A larger ICC indicates measurements have greater repeatability. Greater than 0.75 indicated excellent repeatability; 0.40 to 0.75 indicated fair to good, and less than 0.40 indicated poor reliability.|Month 6 visit, 1 hour|not all eyes were included in this sub- analysis. inconclusive results were not included.|||Intraclass correlation coefficients|eyes|95% Confidence Interval|Number
2570716|NCT02526654|Primary|Correlation Coefficient Between HEP and OVF Mean Deviation (MD)|Pearson's correlation coefficient between Heidelberg Edge Perimeter (HEP) and Octopus Visual Field (OVF) Mean Deviation (MD) for glaucoma patients and controls to determine if HEP can detect glaucoma as well as OVF. The closer the values of both parameters for both machines, the better comparable the two machines are to each other in detecting glaucoma.|Baseline visit, 1 hour||||Pearson's correlation coefficient|||Number
2570717|NCT02526550|Secondary|Percentage of Number of Participants Reporting Immediate Reactions, Solicited Injection Site and Systemic Reactions, Unsolicited Adverse Events, and Serious Adverse Events Following Vaccination With IMOJEV™|Immediate reactions: any reactions occurred within 30 minutes following vaccination; Solicited injection site reactions: Injection site Pain, Redness, and Swelling; Solicited systemic reactions: Fever (Temperature), Crying/Irritability, Drowsiness, Low Appetite and Skin Rash; Unsolicited adverse events: any adverse events spontaneously reported by participants regardless the causal relationship of adverse events to vaccine; Serious adverse events: Any adverse events that resulted in any of the following outcomes: death, a life threatening adverse event, in patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability / incapacity, a congenital anomaly/birth defect, or any important medical events based upon appropriate medical judgment.|Up to 28 days post booster vaccination||||percentage of participants|||Number
2570718|NCT02526550|Secondary|Change From Baseline in Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination|Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.|Day 0 (Baseline) and Day 28 (post-vaccination)||||percentage of participants|||Number
2570719|NCT02526550|Primary|Change From Baseline in Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus at 28 Days Post Vaccination|Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).|Day 0 (Baseline) and Day 28 (post-vaccination)|Per-protocol analysis|||titers||95% Confidence Interval|Geometric Mean
2570720|NCT02526524|Primary|Change in HbA1c (%) at 16 Weeks||Baseline and 16 weeks after the first dose of study medication|Modified Intent-to-Treat: Subjects who took ≥1 dose of randomized study medication and had ≥1 post-Baseline value for HbA1c collected ≤1 week after discontinuing study medication and prior to administration of any new anti-diabetic medication with timing and/or dosage that may have reasonably influenced any subsequent glycemic data collected.|||% glycated haemoglobin||Standard Error|Least Squares Mean
2570721|NCT02526290|Other Pre-specified|Device-related Adverse Events|Number of subjects who experienced any device-related adverse events.|6 months|The safety population included all subjects who received an investigational device and initiated neurostimulation.|||participants|||Number
2570722|NCT02526290|Secondary|Slit Lamp Biomicroscopy|Number of subjects with clinically significant (CS) findings noted from the slit lamp biomicroscopy examinations. A slit lamp biomicroscopy examination of the eyelids, cornea, conjunctiva, anterior chamber, and lens was performed at each visit for each eye. The results were graded as normal, abnormal not clinically significant (NCS), or abnormal CS. In addition, the cornea was scored specifically for corneal edema using a 4-point scale (0=None, +1=Mild, +2=Moderate and +3=Severe). An increase in corneal edema grade of two or more was considered clinically significant and evaluated as a potential AE by the investigator.|6 months|The safety population included all subjects who received an investigational device and initiated neurostimulation.|||participants|||Number
2570723|NCT02526290|Secondary|Corrected Distance Visual Acuity|Change from baseline (Day 0) in corrected distance visual acuity at Day 180. Corrected visual acuity was obtained using the subject's own glasses (for subjects that wear glasses) and measured in logMAR (log of the Minimum Angle of Resolution) units using an appropriate eye chart. A logMAR score of 0.0 is equivalent to a visual acuity of 20/20 and larger logMAR values indicate a poorer visual acuity (eg. A value of 0.3 corresponds to a visual acuity of 20/40).|Baseline and 6 months|The safety population included all subjects who received an investigational device and initiated neurostimulation.|||LogMAR||Standard Deviation|Mean
2570724|NCT02526290|Primary|Stimulated Acute Tear Production|Stimulated acute tear production in the study eye at Day 180 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm.|The stimulated and prestimulation (basal) measures were both performed at Day 180.|The Full Analysis Set (FAS) population included all subjects who received an investigational device and initiated neurostimulation.|||Scores on a scale||Standard Deviation|Mean
2570770|NCT02525536|Primary|Cmax: Maximum Observed Serum Concentration for AMG 386 After Week 4 Dose|Cmax is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve.|Week 4: predose, 1, 2, 6, 24, 48, 96, 168 and 264 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.|||mcg/mL||Standard Deviation|Mean
2570725|NCT02526277|Secondary|Changes in Sleep as Measured by the Medical Outcomes Sleep Study Scale at Week 4 From Baseline.|The Medical Outcomes Study Sleep Scale (MOS-Sleep) includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. Medical Outcomes Sleep Study scale: Participants answer a series of 12 questions assessing quality of sleep, with values ranging from 1 to 6. The lower the score the more severe the sleep disturbance(s); higher the score the better the sleep quality.|Baseline to 4 weeks||||score on a scale||95% Confidence Interval|Mean
2570726|NCT02526277|Secondary|The Restless Legs Quality of Life Questionnaire|"Participants answer a series of 18 questions that are scored such that lower scores indicate worse quality of life. The scoring process for the RLSQoL is relatively complicated. Items 1-5, 7-10, and 13 use scales ranging from 1 to 5, with lower scores indicating a greater frequency and interference of restless legs syndrome. The total score for these items is converted to a value between 0 and 100 using an algorithm provided along with the scale. Items 6 and 16-18 require respondents to indicate how many days in the previous month or hours in the previous day they have been able to complete certain activities or have had their daily functioning interfered with. These items are scored as continuous variables (for example, ranging from 0 to 28 days for questions regarding the number of days per month). Items 11, 12, 14, and 15 are categorical variables, where a response of yes receives (a 1), a response of no receives (a 2), and a response of not applicable receives (3a)."|Baseline to 4 weeks||||score on a scale||95% Confidence Interval|Mean
2570727|NCT02526277|Primary|The International Restless Legs Severity Scale|Participants answer a series of 10 questions each of which have values ranging from 0 to 4, the points are then added together. Higher values are associated with more severe symptoms; up to a maximum severity score of 40 points and a minimum severity of 0 points.|Baseline to 4 weeks: Average change score compared to Control/No treatment group||||score on a scale||95% Confidence Interval|Mean
2570728|NCT02525874|Secondary|Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48|The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'number analyzed' signifies number of participants analyzed at each timepoint.|||milligram per deciliter||Standard Deviation|Mean
2570729|NCT02525874|Secondary|Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48|The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'number analyzed' signifies number of participants analyzed at each timepoint.|||g/L||Standard Deviation|Mean
2570730|NCT02525874|Secondary|Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48|The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'number analyzed' signifies number of participants analyzed at each timepoint.|||mg/L||Standard Deviation|Mean
2570731|NCT02525874|Secondary|Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks||Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48|The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'number analyzed' signifies number of participants analyzed at each timepoint.|||milligram per liter (mg/L)||Standard Deviation|Mean
2570732|NCT02525874|Primary|Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen|VLA-4/LFA-1 antigen subsets include CD11a+ (% of B cells), CD11a+ (% of T cells), CD11a+ (% of MNC), CD11a+ (% of dendritic cells [CD11c++]), CD11a+ (% of lymphocytes), CD11a+ (% of monocytes), CD11a+ (% of neutrophils), CD49d+ (% of B cells), CD49d+ (% of T cells), CD49d+ (% of MNC), CD49d+ (% of dendritic cells [CD11c++]), CD49d+ (% of lymphocytes), CD49d+ (% of monocytes) and CD49d+ (% of neutrophils).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48|The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'Number analyzed' signifies number of participants analyzed at specified timepoint for each subset.|||cells/mm^3||Standard Deviation|Mean
2570733|NCT02525874|Primary|Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines|T-cell cytokine subsets include IFN (interferon) g+ (% of CD4+ T cells), IFNg+ (% of CD8+ T cells), IFNg+ (% of memory CD4+ T cells), IFNg+ (% of memory CD8+ T cells), IL- (interleukin) 17A+/IFNg- (% of CD4+ T cells), IL-17A+/IFNg- (% of CD8+ T cells), IL-17A+/IFNg- (% of memory CD4+ T cells), IL-17A+/IFNg- (% of memory CD8+ T cells), IL-2+ (% of CD4+ T cells), IL-2+ (% of CD8+ T cells), IL-2+ (% of memory CD4+ T cells), IL-2+ (% of memory CD8+ T cells), IL-4+ (% of CD4+ T cells), IL-4+ (% of CD8+ T cells), IL-4+ (% of memory CD4+ T cells) and IL-4+ (% of memory CD8+ T cells). Here, Change at week is represented as CW.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48|The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'Number analyzed' signifies number of participants analyzed at specified timepoint for each subset.|||cells/mm^3||Standard Deviation|Mean
2570734|NCT02525874|Primary|Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells|Myeloid and natural killer cell subsets include CD56Bright NK cells, CD56Dim NK cells, Classical Monocytes, Myeloid dendritic cells, Non-classical Monocytes, Plasmacytoid dendritic cells, Total dendritic cells and Total monocytes [CD14+].|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48|The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'Number analyzed' signifies number of participants analyzed at specified timepoint for each subset.|||cells/mm^3||Standard Deviation|Mean
2570735|NCT02525874|Primary|Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets|B-cell subsets include CD10+ Transitional B cells, CD138+ Plasma Cells, Ig (Immunoglobulin) D+ Memory B cells [non-class switched], IgD- Memory B cells [class switched], Naïve B cells, Plasma Cells [CD10-], Transitional B-cells and Plasmablasts. Here, Change at week is represented as CW.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48|The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'Number analyzed' signifies number of participants analyzed at specified timepoint for each subset.|||cells/mm^3||Standard Deviation|Mean
2570736|NCT02525874|Primary|Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets|T-cells subsets includes Activated CD4+ T-cell, Activated CD8+ T-cell, Activated CD8+ T-cell [CD38+], Activated Th (T helper) 1 phenotype, Activated Th17 phenotype, Activated Th2-enriched phenotype, Activated CD4+ T-cell [CD38+HLA-DR+], Activated CD4+ T-cell [HLA-DR+], Activated CD8+ T-cell [HLA-DR+], Central Memory (CM) CD4+ T-cell [CD45RA-CCR7+], CM CD4+ T-cell [CD45RA-CCR7+], CM CD8+ T-cell [CD45RA-CCR7+], Effector CD4+ T-cell [CD45RA+CCR7-], Effector CD8+ T-cell [CD45RA+CCR7-], Effector Memory (EM) CD4+ T-cell [CD45RA-CCR7-], EM CD8+ T-cell [CD45RA-CCR7-], Effector Regulatory T-cells, Effector CD4+ T-cell [CD45RA+CCR7-], Effector CD8+ T-cell [CD45RA+CCR7-], Naïve CD4+ T-cell [CD45RA+], Naïve CD8+ T-cell [CD45RA+], Naïve (N) CD8+ T-cell [CD45RA+], Naïve Regulatory T-cells, Terminal Effector Regulatory T-cells, Th1 phenotype, Th17 phenotype, Th2-enriched phenotype. Here, Change at week is represented as CW.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48|The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'Number analyzed' signifies number of participants analyzed at specified timepoint for each subset.|||cells/mm^3||Standard Deviation|Mean
2570737|NCT02525874|Primary|Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)|Lymphocyte subsets include T cell, B cell and Natural killer (NK) cells.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48|The PD population was defined as all participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement after baseline. Here 'Number analyzed' signifies number of participants analyzed at specified timepoint for each subset.|||cells per cubic millimeter (cells/mm^3)||Standard Deviation|Mean
2570738|NCT02525718|Secondary|Length of Hospital Stay|Number of postoperative days patients stay in the hospital after surgery|4 days||||Days||Inter-Quartile Range|Median
2570739|NCT02525718|Secondary|Opioid Consumption|"Total opioid consumption in the first 24 hrs of recovery after surgery as measured in morphine equivalents. This involves converting the dose of a non-morphine narcotic (e.g. IV hydromorphone or oral hydrocodone) into the equi-analgesic dose of morphine, so that the total amount of narcotic utilized by the patient can be compared. This is a standard technique for comparison utilized in the pain management literature."|24 hrs||||Morphine equivalents||Inter-Quartile Range|Median
2570740|NCT02525718|Secondary|Pain Score Using 10-point Visual Analog Scale (VAS)|"A study-specific pain form was provided to the patient and nursing staff that consisted of standard visual analogue scale (VAS) for patients to rate their pain level. Pain level was rated as a categorical level from 0 to 10, in 1 unit increments, with 0 being no pain at all and 10 being worst pain imaginable. Thus a total of 10 pain grades were possible."|24 hrs||||score on a scale||Inter-Quartile Range|Median
2570741|NCT02525718|Primary|Quality of Recovery Score|"The primary outcome measure is a well-validated and widely used survey measuring the quality of recovery from anesthesia entitled the Global 40 Item Quality of Recovery survey. This is a 40 question survey administered to patients to allow them to rate their quality of recovery along a number of different dimensions, including emotional state, physical comfort, psychological support, physical independence, and pain. The score ranges from 40 to 200, with 40 representing a very poor overall quality of recovery and 200 representing the best possible recovery. The following reference explains the Global 40 Item Quality of Recovery survey in detail:~Myles, P.S., et al., Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth, 2000. 84(1): p. 11-5.~PMID: 10740540"|24 hours post-operatively||||score on a scale||Inter-Quartile Range|Median
2570742|NCT02525627|Secondary|Merle D'Aubergine Score (MdA)|The Merle D'Aubergine-Charnley Score is a simplified clinical scoring system for the hip. The overall score is determined by the sum of scores obtained from each dimension of pain, walking ability and joint mobility. The overall numeric score is given by adding the domain scores. Clinical grades: Excellent, 18, Good 15-17, Fair 13-14, Poor <13.|6 weeks, 3 months, 1, 2 and 5 years|Merle D'Aubergine Score (MdA) data were not measured at the investigation site.||||||
2570743|NCT02525627|Secondary|Harris Hip Score (HHS) Patient Questionnaire|Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor.|6 weeks, 3 months, 1, 2 and 5 years|Participants with available data. Overall number of participants analysed is based upon the 6 week population.|||units on a scale||Standard Deviation|Mean
2570744|NCT02525627|Primary|To Compare Wear of the Polyethylene X3 Insert Based on Digital Radiographs Using the Hip Analysis Suite (HAS).|Determine equality of 5 year wear in the 28mm and the 40mm metal femoral head sizes using HAS, a software for the determination of polyethylene wear on digital radiographs.|5 years follow-up|Wear data were not measured at the investigation site.||||||
2570745|NCT02525588|Secondary|Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire|The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.|Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years|Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale||Standard Deviation|Mean
2570746|NCT02525588|Secondary|Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire|"The EuroQol-5 Dimension (EQ-5D) is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the visual analogue scale (VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health.~With the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status)."|Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years|Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale||Standard Deviation|Mean
2570811|NCT02524418|Secondary|Measurement of Total Procedure Time Using the Spyglass DS|Time in minutes will be calculated for completing the procedure with the Spyglass DS.|approximately 2 hours|83 Spyglass procedures were conducted on the 75 participants|||minutes|number of Spyglass procedures|Full Range|Mean
2570747|NCT02525588|Secondary|Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36)|The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.|Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years|Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale||Standard Deviation|Mean
2570748|NCT02525588|Secondary|Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years|Participants with available data. Overall number of participants and units analyzed is based upon the preoperative population.|||units on a scale||Standard Deviation|Mean
2570749|NCT02525588|Secondary|Assessment of Prosthetic Migration Results After Two Years by RSA.|RSA is a highly accurate technique for the assessment of three-dimensional migration and micro motion of a joint replacement prosthesis relative to the bone it is attached to. This study evaluates the prosthetic migration results with focus of the two years results of the Triathlon CS Peri-Apatite coated tibial and femoral components.|3 and 6 months,1, 2 and 5 years follow-up|The migration of the prosthesis components was calculated with a minimum of four RSA bone markers. In some cases only 3 RSA bone markers was used to calculate the migration, leading to inaccurate orientation matching of the bone markers. These patients are not included in the results describing the two different liner groups.|||mm||Standard Deviation|Mean
2570750|NCT02525588|Primary|Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA).|RSA is a highly accurate technique for the assessment of three-dimensional migration and micro motion of a joint replacement prosthesis relative to the bone it is attached to. Because of the high accuracy, RSA can also be used to measure wear in knee replacements and is used in this study for the assessment of the wear of the two polyethylene inlay types N2Vac polyethylene and X3 polyethylene.|1, 2 and 5 years follow-up|Negative wear values represent a decrease in liner thickness (= wear).|||mm||Standard Deviation|Mean
2570751|NCT02525575|Primary|Beck Hopelessness Scale|Hopelessness is assessed with the Beck Hopelessness Scale, a 20-item self-report measure with true-false items that assess hopelessness and the extent of positive and negative beliefs about the future. Summed scores range from 0 to 20. Scores provide a measure of the severity of self-reported hopelessness: 0-3 minimal, 4-8 mild, 9-14 moderate, and 15-20 severe. Adequate reliability and concurrent validity data exist for this measure, which has been shown to be predictive of eventual suicide in psychiatric inpatients.|Baseline, 3 Month, 6 Month||||score on a scale||Standard Deviation|Mean
2570752|NCT02525575|Primary|Beck Depression Inventory-II|Depression will be measured with the Beck Depression Inventory-II. This scale consisting of 21 items and scored based on a Likert scale, has high internal consistency (Cronbach coefficient = .92). Each question has a set of at least four possible answer choices, ranging in intensity. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is used to quantify the participant's degree of depression from 0 = no depression to 63 = maximally severe depression.|Baseline, 3 Month, 6 Month||||score on a scale||Standard Deviation|Mean
2570753|NCT02525575|Primary|Columbia Suicide Rating Scale (C-SSRS)|"The Columbia Suicide Rating Scale (C-SSRS) will be used to count prospective or treatment emergent suicidal behaviors. The C-SSRS has been used in many treatment trials, and to measure treatment emergent suicidal events during pharmacotherapy.~C-SSRS contains a subscale on suicidal ideation which is scored from 1-5; higher numbers indicate increased suicidal thinking. The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt according to the C-SSRS."|Baseline, 3 Month, 6 Month||||score on a scale||Standard Deviation|Mean
2570754|NCT02525575|Primary|Beck Scale for Suicide Ideation (BSS)|Beck Scale for Suicide Ideation is designed to assess severity of suicidal attitudes and plans for suicide. BSS is a 21 item self-report, rated on a scale of 0-2, with a total score range of 0-38 with higher score indicating higher ideation.|Baseline, 3 Month, 6 Month||||score on a scale||Standard Deviation|Mean
2570755|NCT02525536|Primary|Accumulation Ratio (AR) for AMG 386|Accumulation ratio (AR) was calculated by dividing the individual AUC (0-tau) value at Week 4 by the corresponding individual AUC (0-tau) value at Week 1.|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after end of infusion, Week 2: predose, Week 4: predose, 1, 2, 6, 24, 48, 96, and 168 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.|||ratio||Standard Deviation|Mean
2570756|NCT02525536|Primary|Systemic Clearance at Steady State (CLss) for AMG 386|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Systemic clearance at steady state (CLss) was calculated as the ratio of dose administered to AUC (0 - tau), where AUC (0 - tau) is the area under the serum concentration-time curve during a dosing interval, where tau is the length of the dosing interval (168 hours for once weekly regimen). CLss was normalized to participant's body weight.|Week 4: predose, 1, 2, 6, 24, 48, 96 and 168 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.|||milliliter/hour/kilogram(mL/hr/kg)||Standard Deviation|Mean
2570757|NCT02525536|Primary|Terminal Phase Elimination Half-life (T1/2) for AMG 386|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.|Week 4: predose, 1, 2, 6, 24, 48, 96, 168 and 264 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.|||hr||Standard Deviation|Mean
2570793|NCT02524977|Secondary|Antithrombotic Therapy Discordant From AFDST Among Patients for Whom AFDST Report Was Reviewed|Change in discordance between decision support tool recommendation and actual treatment among patients whose physicians reviewed the decision support tool report.|One year|Number of patients for whom antithrombotic therapy was discordant from AFDST recommendation among patients for whom AFDST report was reviewed|||Participants|||Count of Participants
2570758|NCT02525536|Primary|Vss: Volume of Distribution at Steady State for AMG 386|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state, estimated as: Vss = MRTinf *CLss, where MRTinf is mean residence time of drug extrapolated to infinity and CLss is the systemic clearance at the steady state. Vss was normalized to participant's body weight.|Week 4: predose, 1, 2, 6, 24, 48, 96, 168 and 264 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.|||milliliter per kilogram (mL/kg)||Standard Deviation|Mean
2570759|NCT02525536|Primary|Cmin: Minimum Observed Serum Trough Concentration for AMG 386 After Week 4 Dose|Cmin was the observed serum concentration at 168 hours postdose.|Week 4: 168 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.|||mcg/mL||Standard Deviation|Mean
2570760|NCT02525536|Primary|Cmin: Minimum Observed Serum Trough Concentration for AMG 386 After Week 1 Dose|Cmin was the observed serum concentration at 168 hours postdose.|Week 2: predose|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 1 assessment available.|||mcg/mL||Standard Deviation|Mean
2570761|NCT02525536|Primary|AUC (0-tau): Area Under the Serum Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for AMG 386 After Week 4 Dose|AUC (0-tau) is the area under the serum concentration-time curve during a dosing interval, where tau is the length of the dosing interval (168 hours for once weekly regimen).|Week 4: predose, 1, 2, 6, 24, 48, 96, and 168 hours after end of infusion|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 4 assessment available.|||mcg*hr/mL||Standard Deviation|Mean
2570762|NCT02525536|Primary|AUC (0-tau): Area Under the Serum Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for AMG 386 After Week 1 Dose|AUC (0-tau) is the area under the serum concentration-time curve during a dosing interval, where tau is the length of the dosing interval (168 hours for once weekly regimen).|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after end of infusion, Week 2: predose|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 1 assessment available.|||microgram*hour/milliliter (mcg*hr/mL)||Standard Deviation|Mean
2570763|NCT02525536|Secondary|Number of Participant With Anti-AMG 386 Antibody|The immunogenicity of AMG 386 was evaluated with an immunoassay that detects anti-AMG 386 binding antibodies. Antibody formation reported at any of the time points was summarized.|Week 1: predose,1,2,6,24,48 and 98 hours after infusion end, Week 3: predose, Week 4: predose, 1,2,6,24,48,96,168 and 264 hours after infusion end, thereafter predose every 4 weeks starting from Week 8 up to 8 weeks after last dose (last dose=Week 249)|Safety analysis set: all participants who received at least 1 dose of AMG 386.|||participants|||Number
2570764|NCT02525536|Secondary|Percent Change From Baseline to Post-baseline in the Sum of the Longest Diameters of Tumor|The percent change from baseline to post-baseline is the largest percent reduction from baseline among all post-dose measures of the sum of the longest diameter of the tumor burden.|Baseline, assessed every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Response evaluable analysis set: a subset of participants in the FAS with at least 1 measurable lesion at baseline using the RECIST 1.0 and valid post-baseline tumor lesion assessment available. FAS consisted of all participants who had evaluable data and received at least 1 dose of AMG 386.|||percent change||Standard Deviation|Mean
2570765|NCT02525536|Secondary|Time to Progression (TTP)|TTP is defined as the time from the date of first administration of study treatment to the date of first documentation of PD or death caused by progression. For participants who did not have a documented PD or died owing to causes other than progression, TTP was censored at the time of last response assessment. PD is defined as at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the baseline smallest sum of longest diameter or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.|Baseline, assessed every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Response evaluable analysis set: a subset of participants in the FAS with at least 1 measurable lesion at baseline using the RECIST 1.0. FAS consisted of all participants who had evaluable data and received at least 1 dose of AMG386.|||Days||Full Range|Median
2570766|NCT02525536|Secondary|Percentage of Participants With Objective Response|Objective response rate defined as the rate of participants with CR or PR based on RECIST 1.0 criteria. CR: disappearance of all target lesions, non-target lesions and normalization of tumor marker level. PR: at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.|Baseline, assessed every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Response evaluable analysis set: a subset of participants in the FAS with at least 1 measurable lesion at baseline using the RECIST 1.0. FAS consisted of all participants who had evaluable data and received at least 1 dose of AMG 386.|||Percentage of participants||95% Confidence Interval|Number
2570767|NCT02525536|Secondary|Number of Participants With Best Overall Response|Best overall response for a participant is the best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria. Complete Response (CR): disappearance of all target lesions, non-target lesions and normalization of tumor marker level. Partial Response (PR): at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the baseline smallest sum of longest diameter; persistence of 1 or more non-target lesion(s) or maintenance of tumor marker level above the normal limits. PD: at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the baseline smallest sum of longest diameter or appearance of 1 or more new lesions or unequivocal progression of existing non-target lesions.|Baseline, assessed every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Response evaluable analysis set: a subset of participants in the full analysis set (FAS) with at least 1 measurable lesion at baseline using the RECIST 1.0. FAS consisted of all participants who had evaluable data and received at least 1 dose of AMG 386.|||participants|||Number
2570771|NCT02525536|Primary|Cmax: Maximum Observed Serum Concentration for AMG 386 After Week 1 Dose|Maximum observed serum concentration (Cmax) is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve.|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after end of infusion, Week 2: predose|Pharmacokinetic analysis set: all participants who had at least 1 evaluable serum concentrations, received at least 1 dose of AMG 386, and had Week 1 assessment available.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2570772|NCT02525536|Primary|Number of Participants With Abnormal Laboratory Values|The number of participants with any abnormal standard safety laboratory values collected throughout study. Parameters assessed were hematology, chemistry, coagulation and urinalysis. Abnormal laboratory values observed at any time point was summarized and reported.|Week 1: predose, 24, 48 and 96 hours after infusion end, Week 2 and 3: predose, Week 4: predose and 1 hour after infusion end, thereafter every 4 weeks starting from Week 8 up to 4 weeks after the last dose of study drug (last dose=Week 249)|Safety analysis set: all participants who received at least 1 dose of AMG 386.|||participants|||Number
2570773|NCT02525536|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, diastolic and systolic blood pressure, and pulse (beats per minutes). clinically significant change in vital signs observed at any time point was summarized and reported.|Week 1: predose, 1, 2, 6, 24, 48 and 96 hours after infusion end, Week 2, 3, 4: predose and 1 hour after infusion end, thereafter predose of every 4 weeks starting from Week 8 up to 4 weeks after the last dose of study drug (last dose=Week 249)|Safety analysis set: all participants who received at least 1 dose of AMG 386.|||participants|||Number
2570774|NCT02525536|Primary|Number of Participants With Significant Change From Baseline in Electrocardiogram (ECG)|Change relative to baseline in electrocardiogram measured throughout study. Significant change in ECG observed at any time point was summarized and reported.|Week 1: predose, 1, 6 hours after end of infusion, Week 4: predose, 1 hour after end of infusion, Week 8, 16: predose, thereafter predose of every 8 weeks up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Safety analysis set: all participants who received at least 1 dose of AMG 386.|||participants|||Number
2570775|NCT02525536|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (AEs) and Serious Adverse Event (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Treatment emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Baseline up to 4 weeks after the last dose of study drug, where last dose was given up to Week 249|Safety analysis set: all participants who received at least 1 dose of AMG 386.|||participants|||Number
2570776|NCT02525536|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|DLT is defined as any treatment-related, grade 4 or higher hematologic or grade 3 or higher non-hematologic toxicity (according to the Common Terminology Criteria for Adverse Events [CTCAE] version 3.0; hematologic toxicity means any toxicities which are categorized in blood/bone marrow category of CTCAE), except for aspartate aminotransferase (AST), alanine aminotransferase (ALT) and infusion reaction, occurred during the first 28 days after the initial administration (before examination on Study Day 29). DLT also includes AST or ALT: >10*upper limit of normal (ULN) international units per liter (IU/L).|Day 1 up to Day 28|DLT analysis set: all participants who experience at least 1 DLT in the first 28 days of treatment, or who received all planned AMG 386 dose and are followed until the day before the treatment on Study Day 29.|||participants|||Number
2570777|NCT02525523|Primary|Proportion of Patients With a Reduction in Relative Stool Frequency|Group of patients with a lowering of stool frequency from baseline to week 10, where the subject's stool frequency is represented by a MAYO subscore of ≤1 at week 10.|Week 10||||Participants|||Count of Participants
2570778|NCT02525523|Primary|Proportion of Patients With Endoscopic Remission|The group of patients with an improvement in their endoscopic score between screening and week 10 as shown by an reduced modified MAYO score. Remission is defined as absence of friability and ulceration, represented by a score of ≤1.|Week 10||||Participants|||Count of Participants
2570779|NCT02525094|Secondary|Number of Participants Who Developed Detectable MEDI9929 Anti-drug Antibodies|A participant was considered ADA-positive across the study if they had a positive reading (titer of 50 or higher) at any time point during the study period.|Baseline (Day 1) to Week 22|ITT population included all participants who were randomized and received any study investigational product.|||Participants|||Count of Participants
2570780|NCT02525094|Secondary|Mean Trough Serum Concentration of MEDI9929|The mean serum concentrations of MEDI9929 was observed at specified timepoints.|Week 0 (Pre dose), Weeks 4, 8, and 12 (post dose)|PK population included all participants who received MEDI9929 and had a sufficient number of serum concentration measurements for computing PK parameters.|||mcg/mL||Standard Deviation|Mean
2570790|NCT02525094|Primary|Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI 50) at Week 12|The eczema area and severity index (EASI) evaluates 4 natural anatomical regions for severity (0 [none] to 3 [severe]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease. The EASI50 responder defined as a participant who achieved at least 50% reduction in EASI score from baseline.|Baseline (Day 1) and Week 12|Intent-To-Treat (ITT) population included all participants who were randomized and received any study investigational product.|||Percentage of participants|||Number
2570791|NCT02525055|Other Pre-specified|Incidence (Number and Percentage [%]) of Viral Challenge Emergent Adverse Events||8 days|||||||
2571996|NCT02512393|Other Pre-specified|NIH PROMIS-cognition Will be Compared Between the Two Groups for a Change Between Baseline and Day 5|A score of 50 is the average and a score of 60 is better than average. A score of 40 is the worse score.|Change from baseline and day 5|||||||
2570781|NCT02525094|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An Adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of investigational product, whether or not considered related to investigational product. Serious adverse event is any AE that resulted in:death;inpatient hospitalization or prolongation of existing hospitalization;persistent or significant disability or incapacity;is life-threatening;is a congenital anomaly/birth defect in offspring of a study participant;or was an important medical event that may not have resulted in death, threatened life,or required hospitalization and that, based on appropriate medical judgment, may have jeopardized participant and may have required medical or surgical intervention to prevent one of outcomes above. TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug until Week 22.|From treatment administration (Day1) to 22 weeks|"As-treated population included all participants who received any study drug. Participants who received at least one dose of MEDI9929 during study, regardless of randomized treatment assignment, were analyzed under MEDI9929. One participant who randomized to placebo but received an incorrect first dose of MEDI9929 was included in MEDI9929 group."|||Participants|||Count of Participants
2570782|NCT02525094|Secondary|Mean Change From Baseline in 5-D Pruritus Score at Week 12|The 5-D pruritus scale is a brief questionnaire designed to assess itch. This scale takes into account the multidimensional nature of pruritus, its impact on quality of life, and is capable of detecting change over time. The 5-D pruritus scale included 5 domains (duration, degree, direction, disability, and distribution of pruritus). The total 5-D score was obtained by scoring each of the domains separately and then summing them together. 5-D total scores ranged between 5 (no pruritus) and 25 (most severe pruritus). The higher values indicating more severe pruritus.|Baseline (Day 1) and Week 12|ITT population included all participants who were randomized and received any study investigational product.|||units on a scale||Standard Deviation|Mean
2570783|NCT02525094|Secondary|Mean Change From Baseline in Average Pruritus Numeric Rating Scale (NRS) at Week 12|Pruritus is assessed using an Numeric Rating Scale (NRS) (0 - 10) with 0= no itch and 10= worst imaginable itch. Daily pruritus assessments were summarized as weekly peak score and a change from baseline in weekly peak score was calculated.|Baseline (Day 1) and Week 12|ITT population included all participants who were randomized and received any study investigational product.|||units on a scale||Standard Deviation|Mean
2570784|NCT02525094|Secondary|Percentage of Participants Achieving >= 75% Reduction From Baseline in SCORAD 75|The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease. The SCORAD 75 responder is defined as a participant who achieves at least a 75% reduction in SCORAD score from baseline.|Baseline (Day 1) and Week 12|ITT population included all participants who were randomized and received any study investigational product.|||Percentage of participants|||Number
2570785|NCT02525094|Secondary|Percentage of Participants Achieving >= 50% Reduction From Baseline in SCORAD 50|The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease. The SCORAD 50 responder defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline.|Baseline (Day 1) and Week 12|ITT population included all participants who were randomized and received any study investigational product.|||Percentage of participants|||Number
2570786|NCT02525094|Secondary|Mean Change From Baseline in the Scoring of Atopic Dermatitis (SCORAD) at Week 12|The scoring of atopic dermatitis (SCORAD) is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The range of the SCORAD is 0-103, where 0 indicates no eczema. The higher values indicating more severe disease.|Baseline (Day 1) and Week 12|ITT population included all participants who were randomized and received any study investigational product.|||units on a scale||Standard Deviation|Mean
2570787|NCT02525094|Secondary|Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline|The investigator's global assessment (IGA) allows investigators to assess overall disease severity at one given time point and consists of a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, and 4 = severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline.|Baseline (Day 1) and Week 12|ITT population included all participants who were randomized and received any study investigational product.|||Percentage of participants|||Number
2570788|NCT02525094|Secondary|Mean Change From Baseline in EASI Total Score at Week 12|The EASI evaluates 4 natural anatomical regions for severity (0 [none] to 3 [severe]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease.|Baseline (Day 1) and Week 12|ITT population included all participants who were randomized and received any study investigational product.|||units on a scale||Standard Deviation|Mean
2570789|NCT02525094|Secondary|Percentage of Participants Achieving >= 75 % Reduction From Baseline in EASI75 at Week 12|The EASI evaluates 4 natural anatomical regions for severity (0 [none] to 3 [severe]) and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The total score is the sum of the four body-region scores, maximum=72, minimum=0. The higher values indicating more severe disease. The EASI75 responder defined as a participant who achieves at least a 75% reduction in EASI score from baseline.|Baseline (Day 1) and Week 12|ITT population included all participants who were randomized and received any study investigational product.|||Percentage of participants|||Number
2570792|NCT02525055|Primary|Area Under the Curve of Virus Load|Area under the curve (AUC) of the Challenge Viral load, measured by nasopharyngeal swab quantitative polymerase chain reaction [qPCR], from Day 1 to Day 8 post-Viral Challenge. Nasopharyngeal swabs are collected up to 3 times per day ( every 8 hours +/- 30mins)|8 days||||mins*Eq log10 TCID50/mL||Standard Deviation|Mean
2570794|NCT02524977|Primary|Changes in Discordant Antithrombotic Therapy|Changes in the proportion of patients with current therapy that was discordant from the decision support tool recommendation between the start and finish date of the study (one year period).|One year|Patients with an International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis of AF (427.31) or atrial flutter (427.32) who did not have diagnoses of mitral valve disease (394.x), aortic valve disease (395.x), heart valve transplant (V42.2), or heart valve replacement (V42.3) in their active problem list.|||participants|||Number
2570795|NCT02524665|Secondary|Percentage of Participant Who Improved by at Least One Grade on the ISGA|During each study visit, investigators/expert grader evaluated the acne severity of participants' faces using the ISGA scale on right and left side of face on a five point scale from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Percent change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1.|Up to Week 8|ITT analysis set. Only those participants with data available at the indicated time points were analyzed.|||Percentage of participants|||Number
2570796|NCT02524665|Secondary|Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8.|Redness, dryness, burning, itching and scaling were evaluated independently by the participant on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1.|Baseline and Week 1, 2, 4, 8|ITT analysis set. Only those participants with data available at the indicated time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2570797|NCT02524665|Secondary|Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.|Erythema (redness), dryness, and peeling, were evaluated independently by the investigator on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1.|Baseline and Week 1, 2, 4, 8|ITT analysis set. Only those participants with data available at the indicated time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2570798|NCT02524665|Secondary|Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Week 1, 2, 4 and 8|During each study visit, investigators/expert grader evaluated the acne severity of participants' faces using the ISGA scale on right and left side of face on a five point scale from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1.|Baseline and Week 1, 2, 4, 8|ITT analysis set. Only those participants available at the indicated time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2570799|NCT02524665|Secondary|Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 1, 2 and 4.|During each study visit, expert grader (blinded evaluator) assessed the left side and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) and total lesions for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1.|Baseline and Week 1, 2, 4|ITT analysis set. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).|||Percent change||Standard Deviation|Mean
2570800|NCT02524665|Primary|Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 8.|During each study visit, expert grader (blinded evaluator) assessed the left side and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open [blackheads] and closed [whiteheads] comedones) and total lesions for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 8 was calculated as the value at Week 8 minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1.|Baseline and Week 8|Intent-to-treat (ITT) analysis set was used which included data from all randomized participants who received study product. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).|||Percent change||Standard Deviation|Mean
2570801|NCT02524561|Secondary|Abnormal Mammogram/Biopsy|Abnormal mammogram requiring additional imaging modality such as MRI or ultrasound, or a breast biopsy. Information obtained from mammography reports.|baseline to 3 years|Women with mammography reports|||Participants|||Count of Participants
2570802|NCT02524561|Primary|BIRADS Breast Density|Frequency of the BIRADS category 3-4 years after randomization. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.|Latest (Year 3 of 4)|Women with mammograms 3-4 years after randomization|||participants|||Number
2570803|NCT02524561|Primary|BIRADS Breast Density|Frequency of the BIRADS category 1 year after randomization. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.|Year 1|Women with mammograms 1 year after randomization|||participants|||Number
2570804|NCT02524561|Primary|BIRADS Breast Density|Breast density prior to randomization. Frequency of the BIRADS category according to randomization status. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.|Baseline (Prior to Randomization)|Women with mammograms are included.|||participants|||Number
2570805|NCT02524418|Secondary|Number of Participants With Successful Removal of the Biliary or Pancreas Stones|The successful removal of the biliary or pancreas stones will be determined by the need for additional procedures.|Day 1|Spyglass-guided stone therapy was attempted in 26 patients with biliary stones|||participants|||Number
2570813|NCT02524418|Primary|Number of Participants With Procedure Technical Success|The performance of the Spyglass DS during the endoscopy will be based on the ability to reach the target site, obtain samples, and to deliver therapeutic intervention.|Day 1|Five of the subjects had both Cholangioscopy and Pancreatoscopy. The results of these procedures were recorded and analyzed separately|||participants|||Number
2570814|NCT02524288|Primary|Number of Participants Who Discontinued Treatment Due to a Drug-related AE|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE. An investigator who is a qualified physician determined whether an AE is drug-related.|From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year)|All randomized participants in whom at least 1 vaginal ring was inserted.|||Participants|||Number
2570815|NCT02524288|Primary|Number of Participants With One or More Drug-related AEs|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE. An investigator who is a qualified physician determined whether an AE is drug-related.|From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year)|All randomized participants in whom at least 1 vaginal ring was inserted.|||Participants|||Number
2570816|NCT02524288|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE.|From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year)|All randomized participants in whom at least 1 vaginal ring was inserted.|||Participants|||Number
2570817|NCT02524288|Primary|Number of Participants With One or More Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE.|From insertion of the first vaginal ring up to and including 14 days after removal of the last vaginal ring (up to approximately 1 year)|All randomized participants in whom at least 1 vaginal ring was inserted.|||Participants|||Number
2570818|NCT02524288|Primary|Number of In-Treatment Pregnancies Per 100 Woman-Years of Exposure in Participants 18-35 Years of Age (Pearl Index)|"The Pearl Index is the number of in-treatment pregnancies with a conception date in any of the in-treatment cycles, divided by all treatment cycles in each participant from the first treatment cycle to the last treatment cycle (due either to discontinuation or completion), regardless of whether a treatment cycle was at risk or not. One woman-year is defined as 13 treatment cycles x 28 days. These efficacy results should be interpreted with caution. Due to the discontinuation of product development and early trial termination, the number of at risk treatment cycles in the denominator is based on uncleaned diary data."|Up to 1 year (13 28-day cycles)|All participants assigned to treatment who inserted at least 1 ENG-E2 ring, and who had at least 1 “at risk” treatment cycle, or participants with a treatment cycle (at risk or not) in which a pregnancy had occurred (i.e., treatment cycle containing an estimated conception date for a pregnancy).|||Pregnancies per 100 woman years|||Number
2570819|NCT02524158|Secondary|Change From Baseline - Lower Spine Stabilization - Core Strength at 12 Weeks|Time in seconds holding plank position on the elbows.|baseline to 12 weeks|Only a subset agreed to assessment. Some declined if concerned about injury. Main outcomes were conducted using linear modeling across multiple time points. This analysis used only 2 time points, with attrition from the 12-week assessment, and incomplete answers accounting for reduced sample size.|||seconds||Standard Error|Mean
2570820|NCT02524158|Secondary|Change From Baseline - Lower Limb Strength and Balance - Eyes Open at 12 Weeks|The Single Leg Stance (SLS) is a commonly used measure of both lower leg strength and balance. A total of four trials were conducted - left and right leg with both eyes open and eyes closed. Each trial will be timed from the moment the participant lifts one foot off the floor until the moment they need to place it on the floor again. If the participant is able to stand on one leg for 60 seconds the trial will be stopped and they will be asked to switch side. Values range from 0 - 60 seconds with greater values indicating better balance.|baseline to 12 weeks|Only a subset agreed to assessment. Some declined if concerned about injury. Main outcomes were conducted using linear modeling across multiple time points. This analysis used only 2 time points, with attrition from the 12-week assessment, and incomplete answers accounting for reduced sample size.|||seconds||Standard Error|Mean
2571085|NCT02520310|Secondary|Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)|Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2570821|NCT02524158|Secondary|Change From Baseline - Grip Strength at 12 Weeks|Grip strength in both hands of each participant will be measured using an adjustable, hydraulic grip strength dynamometer (Jamar Hydraulic Hand Dynamometer). Three trials will be conducted for each hand. In cases of current pain flare-ups or recent procedures to a hand or wrist, the affected hand is not tested, and the result of the one other hand is used. If both hands are used the best performance of two trials will be selected for each side, and the average of the left and right hand will be used for analysis. The value measured is pounds of force exerted and typically ranges from 0 - 150 lbs, with higher numbers indicating greater grip strength.|baseline to 12 weeks|Some participants declined to participate because of injury concern. Main outcomes were conducted using linear modeling across multiple time points. This analysis used only 2 time points, with attrition from the 12-week assessment, and incomplete answers accounting for reduced sample size.|||pounds per sq inch||Standard Error|Mean
2570822|NCT02524158|Secondary|Change From Baseline - Range of Motion - Flexion at 12 Weeks|Spinal Range of Motion (ROM) will be measured using a Saunders Digital Inclinometer, a portable device which isolates lumbar ROM. The device is placed along the spine and uses a precise optical angular scanner. Forward bend angle measures how far forward and downward a person can bend at the waist, from a fully erect and/or normal standing position. The value typically ranges from 0-180 degrees, with higher values indicating greater flexibility.|baseline to 12 weeks|Only a subset agreed to assessment. Some declined if concerned about injury. Main outcomes were conducted using linear modeling across multiple time points. This analysis used only 2 time points, with attrition from the 12-week assessment, and incomplete answers accounting for reduced sample size.|||degrees flexion||Standard Error|Mean
2570823|NCT02524158|Secondary|Attendance/ Home Practice|Two indicators of the amount of yoga practiced by each participant will be used. Actual attendance of yoga sessions will be assessed using VA medical record data. Attendance can range from 0-24 sessions attended for those participants randomized to yoga. Self-reported practice of yoga at home will be assessed using a weekly participant yoga log. The self-report yoga log assesses whether they practiced yoga each day, the amount of minutes practiced, the use of instructions, the difficulty of poses, and the estimated level of physical activity or exertion.|12 weeks||||sessions attended||Standard Error|Mean
2570824|NCT02524158|Secondary|Change From Baseline - Self-efficacy for Managing Low Back Pain at 12 Weeks|Self-efficacy for controlling CLBP reflects levels of confidence in the ability to influence the intensity of back pain symptoms and the impact that CLBP has on daily life. The questions are based on self-efficacy items developed for the Medical Outcomes Study in mixed chronic diseases. The wording of the items has been adapted to be specific to CLBP. The measure consists of 6 items, rated on a 6-point Likert scale, with each item ranging from 0-10. The total score is the mean of the 6 items with higher scores indicating greater self-efficacy for managing CLBP.|baseline to 12 weeks||||units on a scale||Standard Error|Mean
2570825|NCT02524158|Secondary|Change From Baseline - Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks|The PSQI is a validated measure of sleep quality. The global PSQI score has a range of 0-21, with higher scores indicating worse sleep quality.|baseline to 12 weeks|Main outcomes were conducted using linear modeling across multiple time points. This analysis used only 2 time points, with attrition from the 12-week assessment, and incomplete answers accounting for reduced sample size.|||units on a scale||Standard Error|Mean
2570826|NCT02524158|Secondary|Change From Baseline - Brief Anxiety Inventory (BAI) at 12 Weeks|The Brief Anxiety Inventory (BAI) measures the severity of anxiety symptoms, particularly those that distinguish anxiety from depression. The BAI consists of 21 items, is self-administered and can be completed in 5 to 10 minutes. Items are scored on a scale of 0 to 3 and are summed to generate a total score. Scores range from 0 to 63, and higher scores indicate greater depression.|baseline to 12 weeks|Main outcomes were conducted using linear modeling across multiple time points. This analysis used only 2 time points, with attrition from the 12-week assessment, and incomplete answers accounting for reduced sample size.|||units on a scale||Standard Error|Mean
2570827|NCT02524158|Secondary|Change From Baseline - Center for Epidemiologic Studies Short Depression Scale (CES-D 10) at 12 Weeks|Depression will be assessed using the Center for Epidemiologic Studies Short Depression Scale (CES-D 10). Derived from the full CES-D, there are 10 items that ask about the frequency of mood symptoms, rated on a 4-point Likert scale ranging from 0 (Never) to 3 (All of the Time). Scores range from 0 to 30, and higher scores indicate greater depression. A number of items are reverse-scored and a score of 10 or greater is considered depressed. Normative data on people with assorted chronic illnesses are available for comparisons.|baseline to 12 weeks|Main outcomes were conducted using linear modeling across multiple time points. This analysis used only 2 time points, with attrition from the 12-week assessment, and incomplete answers accounting for reduced sample size.|||units on a scale||Standard Error|Mean
2570828|NCT02524158|Secondary|Change From Baseline - EuroQOL 5D (EQ5D) at 12 Weeks|The EQ5D is a preference-based measure of health-related quality of life. The measure produces a single score ranging from 0 (death) to 1.00 (optimal health). Scores can be integrated with time to calculate Quality Adjusted Life Years.|baseline to 12 weeks|Main outcomes were conducted using linear modeling across multiple time points. This analysis used only 2 time points, with attrition from the 12-week assessment, and incomplete answers accounting for reduced sample size.|||units on a scale||95% Confidence Interval|Mean
2570829|NCT02524158|Secondary|Change From Baseline - SF12 MCS at 12 Weeks|Mental Component Scale - Health-related quality of life will be measured using the Short-form 12 (SF12). Based on the longer SF-36, the SF-12 was developed with the objective of finding a short yet meaningful measure of generic HRQOL or global health status. The 12 items were selected from the SF-36 and tested through a series of stages. The PCS-12 and MCS-12 show similar levels of precision to the summary scores derived from the longer 36-item measure. PCS-12 and MCS-12 scores are transformed to a 0 to 100, with higher scores indicating better quality of life.|baseline to 12 weeks||||units on a scale||Standard Error|Mean
2570830|NCT02524158|Secondary|Change From Baseline - SF12 PCS at 12 Weeks|Health-related quality of life will be measured using the Short-form 12 (SF12). Based on the longer SF-36, the SF-12 was developed with the objective of finding a short yet meaningful measure of generic HRQOL or global health status. The 12 items were selected from the SF-36 and tested through a series of stages. The PCS-12 and MCS-12 show similar levels of precision to the summary scores derived from the longer 36-item measure. PCS-12 and MCS-12 scores are transformed to a 0 to 100, with higher scores indicating better quality of life.|baseline to 12 weeks||||units on a scale||Standard Error|Mean
2571997|NCT02512393|Secondary|Endorphin Level||baseline||||ng/mL||Standard Deviation|Mean
2570831|NCT02524158|Secondary|Change From Baseline - Fatigue Severity Scale (FSS) at 12 Weeks|Fatigue (absence of energy) will be measured with the Fatigue Severity Scale (FSS). The FSS is a self-administered instrument developed to assess the impact and severity of fatigue. It consists of 9 items describing the functional impact of fatigue on daily life rated on a scale from 1 (strongly disagree) to 7 (strongly agree) with the total fatigue score ranging from 9-63 or an average score ranging from 1.0-7.0. Higher scores reflect greater fatigue severity and less energy.|baseline to 12 weeks||||units on a scale||Standard Error|Mean
2570832|NCT02524158|Secondary|Change From Baseline Pain Interference - Brief Pain Inventory at 12 Weeks|The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 7 interference items used a as a measure of pain interference. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.|baseline to 12 weeks||||units on a scale||Standard Error|Mean
2570833|NCT02524158|Secondary|Change From Baseline in Pain Intensity - Brief Pain Inventory at 6 Months|The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 4 severity items used as measures of pain severity. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.|baseline to 6 months|Of the 76 participants randomized to each group, 1 participants in each group requested withdrawal of all of their data from the study. Thus, baseline characteristics, outcomes analyses, and outcomes results are reported for 75 participants.|||units on a scale||95% Confidence Interval|Mean
2570834|NCT02524158|Secondary|Change From Baseline in Pain Intensity - Brief Pain Inventory at 12 Weeks|The short version of the Brief Pain Inventory (BPI) is a self-rated questionnaire designed to assess the severity of pain and the impact of pain on daily functions in the past day and week. The BPI takes about 5 minutes to complete and has been validated with low back pain patients. It has been shown to respond to both behavioral and pharmacological pain interventions. The BPI measures severity of pain, impact of pain on daily function, location of pain, pain medications, and amount of pain relief. Items are answered utilizing a scoring algorithm, with the mean of the 4 severity items used as measures of pain severity. Scores range from 0-10, with higher scores indicating more pain, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement.|baseline to 12 weeks|Of the 76 participants randomized to each group, 1 participants in each group requested withdrawal of all of their data from the study. Thus, baseline characteristics, outcomes analyses, and outcomes results are reported for 75 participants.|||units on a scale||95% Confidence Interval|Mean
2570835|NCT02524158|Primary|Roland-Morris Disability Questionnaire|The primary outcome is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline, 12-weeks, and 6-months. The questionnaire consists of 24 questions that ask about back pain-related functional limitations experienced for a variety of daily activities . Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.|baseline to 6-months|Of the 76 participants randomized to each group, 1 participants in each group requested withdrawal of all of their data from the study. Thus, baseline characteristics, outcomes analyses, and outcomes results are reported for 75 participants.|||units on a scale||95% Confidence Interval|Mean
2570836|NCT02524158|Primary|Roland-Morris Disability Questionnaire|The primary outcomes is the change in Roland-Morris Disability Questionnaire (RMDQ) score between baseline and 12-weeks. The questionnaire consists of 24 questions that ask about back pain-related functional limitations experienced for a variety of daily activities . Scores can range from 0-24. Higher scores indicate more impairment, and when considering the change from baseline to follow-up assessments, negative scores indicate improvement. The scale has been shown to be reliable and is well validated. It has been used in another yoga RCT, allowing for comparisons.|baseline to 12 weeks|Of the 76 participants randomized to each group, 1 participants in each group requested withdrawal of all of their data from the study. Thus, baseline characteristics, outcomes analyses, and outcomes results are reported for 75 participants.|||units on a scale||95% Confidence Interval|Mean
2570837|NCT02524145|Primary|Central Command Regulation of Heart Rate|Heart rate response to static hand grip immediately followed by supra-systolic arm occlusion and release will determine adequacy on central command control over heart rate response during exercise.|1 day; primary outcome was complete for each subject in 1 day|Young subjects did not perform handgrip portion of the study.|||beats per minute||Standard Deviation|Mean
2570838|NCT02524145|Primary|Cardiac Beta-receptor Sensitivity|Cardiac beta-receptor sensitivity will be measured by calculating slope of heart rate versus isoproterenol serum level.|1 day; primary outcome was complete for each subject in 1 day||||beats per ng/kg/min ISO||Standard Deviation|Mean
2570839|NCT02524106|Secondary|Change in Lp(a) From Entry to Week 12|The primary endpoint for the study is the percent change from baseline in fasting total Lp(a) at week 12.|week 12|Patients living with well controlled HIV|||percentage change||Full Range|Mean
2570840|NCT02524106|Primary|Change of LDL-C From Baseline to Week 12|The primary endpoint for the study is the percent change from baseline in fasting LDL-C at week 12.|week 12||||percentage change||Full Range|Mean
2570883|NCT02522442|Primary|Group Compliance of the Auto Bilevel Group Compared to the CPAP Group Measured by Average Nightly Use.|Compliance was compared between the AutoBiLevel Group and the CPAP group by measuring the average use per night over the study period.|90 days|One randomized participant discontinued the study early (auto-bilevel Group). One participant in the CPAP group used therapy the first night and failed for the remainder of the study but completed all study visits.|||minutes/night||Standard Deviation|Mean
2570841|NCT02524054|Secondary|Urine Output - mL|"Diuresis is an expected effect of furosemide. To the extent that aerosol furosemide is absorbed in the blood, diuresis is an expected 'side effect' of this treatment.~Following intervention, study team will measure urine output (mL). Study team will then rehydrate subject with an equal amount of liquid to their output."|Summation of total urine output (mL) at 1 hour following drug administration.|The 17 participants in 'Aerosol furosemide Study 2b' and 'Aerosol saline Study 2b' are the results from the same 17 subjects on two different test days.|||ml of urine||Standard Deviation|Mean
2570842|NCT02524054|Primary|Change in Subject Rating of Breathing Discomfort (Dyspnea) Before and After Treatment.|"Subjects will rate breathing discomfort (dyspnea) during a 15 min exercise test using a visual analog scale before and after drug (or placebo) intervention. The treatment effect was measured as the rating of breathing discomfort rating before treatment minus the rating of breathing discomfort after treatment at equivalent work intensities.~Outcome Measure Time Frame: subjects performed arm exercise to induce dyspnea for approximately 15 min before and after aerosol inhalation. the average number of minutes between end of drug administration and post-intervention breathing discomfort rating:~Aerosol furosemide Study 2a arm: 38.7 minutes; Aerosol furosemide Study 2b arm: 21.8 minutes; Aerosol saline Study 2b arm: 21.3 minutes"|15 min||||units on a scale||Standard Deviation|Mean
2570843|NCT02523924|Other Pre-specified|Assessment of Treatment Response by 18F-DCFPyL PET/CT||6 months|||||||
2570844|NCT02523924|Other Pre-specified|Correlation of 18F-DCFPyL PET/CT Findings With Time to Disease Progression||6 months|||||||
2570845|NCT02523924|Secondary|Correlation of Findings on 18F-DCFPyL PET/CT With Tissue Histology and PSMA Expression of Biopsied/Resected Pathology Specimens|Number of sites with 18F-DCFPyL uptake from which biopsy specimens show PSMA expression.|6 months|Data was not collected to assess this outcome measure as confirmatory biopsy was not practical to perform and histopathologic confirmation is not available.||||||
2570846|NCT02523924|Secondary|Correlation of Findings on 18FDCFPyL PET/CT With Those Found on Conventional Imaging (Bone Scan and Cross-sectional Imaging)|Number of sites with uptake on 18F-DCFPyL PET/CT and corresponding lesions identified on conventional imaging.|6 months|Data was not collected for this outcome as participants did not have conventional imaging correlates.||||||
2570847|NCT02523924|Secondary|Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels|Number of participants with PSA 0.2-1.0ng/mL OR PSA >1.0ng/mL with at least 1 site of uptake of 18F-DCFPyL consistent with prostate cancer.|6 months|Only 22/31 participants had a PSA of 0.2-1.0ng/mL and 9/31 participants had PSA >1.0ng/mL.|||Participants|||Count of Participants
2570848|NCT02523924|Primary|Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT|Location of uptake of 18F-DCFPyL consistent with prostate cancer.|6 months|Location of 18F-DCFPyL uptake could only be assessed in patients with at least 1 site of 18F-DCFPyL uptake (26/31)|||Participants|||Count of Participants
2570849|NCT02523924|Primary|Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT|Number of sites with 18F-DCFPyL uptake consistent with prostate cancer.|6 months||||Participants|||Count of Participants
2570850|NCT02523690|Secondary|Change in Quadriceps Strength as Measured by Handheld Dynamometer|Strength (in kilograms) - measured via handheld dynamometry of quadriceps muscle.|Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo||||kilograms||Standard Deviation|Mean
2570851|NCT02523690|Secondary|Change in Quadriceps Strength as Measured by Handheld Dynamometer|Strength (in kilograms) - measured via handheld dynamometry of quadriceps muscle.|Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo||||kilograms||Standard Deviation|Mean
2570852|NCT02523690|Secondary|Change in Manual Muscle Strength as Measured by the Medical Research Council (MRC) Score|Measuring strength of 6 muscle groups in arms and legs using Medical Research Council composite score (each muscle group scored from scale of 0 [no visible or noticeable contraction] to 5 [maximum strength] and the sum of the scores for the 6 muscle groups equate to a composite score ranging from 0 to 60, higher score is better).|Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo||||score on a scale||Standard Deviation|Mean
2570853|NCT02523690|Secondary|Change in Manual Muscle Strength as Measured by the Medical Research Council (MRC) Score|Measuring strength of 6 muscle groups in arms and legs using Medical Research Council composite score (each muscle group scored from scale of 0 [no visible or noticeable contraction] to 5 [maximum strength] and the sum of the scores for the 6 muscle groups equate to a composite score ranging from 0 to 60, higher score is better).|Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo||||score on a scale||Standard Deviation|Mean
2570854|NCT02523690|Secondary|Change in Handgrip Strength as Measured by Hand Dynamometer|Hand grip strength measured using a dynamometer (measured in kilograms, then compared to age- and sex-matched population norms to yield percent predicted strength - higher is better)|Baseline and 2 to 6 hours after administration of 10mg lorcaserin/placebo||||percent of predicted strength||Standard Deviation|Mean
2570855|NCT02523690|Primary|Change in Handgrip Strength as Measured by Hand Dynamometer|Hand grip strength measured using a dynamometer (measured in kilograms, then compared to age- and sex-matched population norms to yield percent predicted strength - higher is better)|Baseline and 2 to 6 hours after administration of 30mg lorcaserin/placebo||||percent of predicted strength||Standard Deviation|Mean
2570856|NCT02523586|Primary|Oxygen Concentration Measured at the Oropharyngeal Location by Nasal Catheter|After placement of each mask and starting oxygen high flow, the subject will breathe normally for 90 seconds and then FiO2 will be measured over the next 30 seconds. At the end of each trial period, each subject will be asked to take a single vital capacity breath (starting with maximum exhalation and followed by maximum inhalation). Between testing of each mask, there will be a 5 minute period of breathing room air as a washout period to confirm stability of hemodynamic status (measurement of blood pressure and heart rate).|The subjects will each participate on one study day and will require 1 hour per subject.||||percentage of oxygen||95% Confidence Interval|Mean
2570884|NCT02522403|Secondary|Visual Analogue Scale (VAS)|"The VAS has a score of 0 to 10. The lowest score (0) represents the absence of pain, while the highest score (10) corresponds to the maximum pain possible.~Only the final results of the study are reported."|6 weeks||||units on a scale||Standard Deviation|Mean
2570885|NCT02522403|Secondary|Wrist Mobility|"The degrees of wrist mobility in flexion, extension, pronation, supination, and radial and ulnar deviation were measured in all patients.~Only the final measures of movements of the study are reported."|6 weeks||||degrees||Standard Deviation|Mean
2570857|NCT02523586|Primary|Oxygen Concentration Measured at the Lips by Datex-Ohmeda Differential Paramagnetic Sensor|After placement of each mask and starting oxygen high flow, the subject will breathe normally for 90 seconds and then FiO2 will be measured over the next 30 seconds. At the end of each trial period, each subject will be asked to take a single vital capacity breath (starting with maximum exhalation and followed by maximum inhalation). Between testing of each mask, there will be a 5 minute period of breathing room air as a washout period to confirm stability of hemodynamic status (measurement of blood pressure and heart rate).|The subjects will each participate on one study day and will require 1 hour per subject.|FiO2 at the lips|||percentage of oxygen||95% Confidence Interval|Mean
2570858|NCT02523235|Secondary|Total Local Anesthetic Infused (Adductor Only) : mL|mL|The day following surgery recorded during mid-day rounds|adductor volume bolus doses volume (excluding basal infusion)|||mL||Inter-Quartile Range|Median
2570859|NCT02523235|Secondary|Toe/Foot Numbness (Insensate) :0-10 Scale|0-10 scale, 0=no numbness and 10=completely insensate|Average for the morning after surgery for 2 hours before phone call made between 10:00-noon (popliteal only)|popliteal-sciatic subjects|||score on a scale||Inter-Quartile Range|Median
2570860|NCT02523235|Secondary|Number of Participants That Had Fluid Leakage Reported at Catheter Site.|"If subjects detected leakage at the catheter site, the response was recorded as yes; and, if subjects did not detect leakage at the catheter site, the response was recorded as no."|From surgery through the day after surgery|adductor canal subjects|||Participants|||Count of Participants
2570861|NCT02523235|Secondary|Pain During Afternoon Physical Therapy Session|Pain during afternoon physical therapy session as measured with the Numeric Rating Scale (0-10; 0=no pain and 10=worst imaginable pain)|Average during physical therapy in the afternoon following surgery|adductor canal afternoon therapy|||score on a scale||Inter-Quartile Range|Median
2570862|NCT02523235|Secondary|Ambulation: Distance in Meters|distance in meters|Average for morning and afternoon following surgery|adductor canal afternoon after surgery|||meters||Inter-Quartile Range|Median
2570863|NCT02523235|Secondary|Analgesic Use: IV Morphine Equivalents|IV morphine equivalents|Average for Intraoperative, in the recovery room, after the recovery room until 08:00 day after surgery, and 08:00-24:00 day after surgery|adductor canal subjects, POD 1 8:00 am through 12 pm|||mg||Inter-Quartile Range|Median
2570864|NCT02523235|Secondary|Pain (Worst) :Numeric Rating Scale for Pain|Numeric Rating Scale for Pain (0-10; 0=no pain and 10=worst imaginable pain)|Average for the day after surgery 08:00-24:00 (adductor) and the morning after surgery for 2 hours before phone call made between 10:00-noon (popliteal)|Adductor canal subjects|||score on a scale||Inter-Quartile Range|Median
2570865|NCT02523235|Primary|Pain (Average): Numeric Rating Scale for Pain|Numeric Rating Scale for Pain (0-10; 0=no pain and 10=worst imaginable pain)|Average for the day after surgery 08:00-24:00 (adductor) and the morning after surgery for 2 hours before phone call made between 10:00-noon (popliteal)|Adductor canal subjects|||score on a scale||Inter-Quartile Range|Median
2570866|NCT02522884|Primary|Safety - Number of Subjects That Met the Primary Safety Criteria of Freedom From Major Adverse Events at 30 Days|Freedom from the occurrence of any new-onset major adverse event(s) (MAEs) defined as index limb amputation (above the ankle), CEC adjudicated clinically-driven target lesion revascularization (CD-TLR), or all-cause death at 30 days.|30 Days|ITT population with available data for this assessment.|||Participants|||Count of Participants
2570867|NCT02522884|Primary|Efficacy - Number of Subjects That Met Primary Patency Criteria at 12 Months|Primary patency defined as freedom from Clinical Events Committee (CEC) adjudicated clinically-driven target lesion revascularization (CD-TLR) and freedom from core lab adjudicated duplex ultrasound derived binary restenosis at 12 months (defined as peak systolic velocity ratio (PSVR) >2.5)|12 Months|ITT population with available data for this assessment.|||Participants|||Count of Participants
2570868|NCT02522728|Secondary|Investigation of Patient Outcome With Radiographic Analysis|Plain radiographs will be obtained for assessment of fixation of the device.|3 months, 1, 2, 5, 7 and 10 years|Plain radiographs were used for disease classification. Additional radiographs were not collected for the assessment of device fixation as the RSA analysis was used as an exact measurement of prosthesis components migration and implant fixation.||||||
2570869|NCT02522728|Secondary|Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire|"The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas; EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health.~With the EQ VAS the respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status)."|1, 2, 5, 7 and 10 years|The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.|||units on a scale||Standard Deviation|Mean
2570870|NCT02522728|Secondary|Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire|KOOS consists of 5 subscales: Pain, other symptoms, function in daily living , function in sport and recreation and knee related quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no problems or a better outcome and 0 indicating extreme problems or a worse outcome).|pre-operative, 3 months, 1, 2, 5, 7 and 10 years|The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.|||units on a scale||Standard Deviation|Mean
2570886|NCT02522403|Primary|Patient-Rated Wrist Evaluation (PRWE)|"The PRWE assesses pain and the inability to perform daily acitivities. Is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. It yields a score of 0 to 100, with lower scores indicanting better performance.~Only the final results of the study are reported."|6 weeks||||units on a scale||Standard Deviation|Mean
2570887|NCT02522377|Secondary|Responder Rate on HAMD-17 by Last Infusion|Count of the patients who showed response (>50% decrease).|visit 17||||Participants|||Count of Participants
2570871|NCT02522728|Secondary|Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: 1. assessment score for pain, range of motion (ROM) and joint stability, 2. score for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|pre-operative, 3 months, 1, 2, 5, 7 and 10 years|The number included in the analysis in one or more rows differs from the overall number analysed because that data were not collected.|||units on a scale||Standard Deviation|Mean
2570872|NCT02522728|Primary|Assessment of Fixation and Stability of the Triathlon Total Knee Prosthesis by Roentgen Stereophotogrammetric Analysis (RSA)|Roentgen Stereophotogrammetric Analysis (RSA) is a technique to measure migration of prosthesis components relative to the bone which allows conclusions regarding the fixation of an implant. This study assesses the fixation and stability of the Triathlon total knee prosthesis at 2 years by RSA as a predictor of late mechanical loosening.|2 years follow-up|The number included in the analysis differs from the overall number analysed because that data were not collected.|||mm||Standard Deviation|Mean
2570873|NCT02522624|Secondary|Intended Choice Metal Level|Participants indicated the plan they would choose that day. We categorized plans by governmental classifications of metal level (catastrophic, bronze, silver, gold).|Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.|Intended plan choice metal level data were not available for 2 participants in SMHP (Show Me My Health Plans decision aid) condition (n=162) and for 11 participants in healthcare.gov (Control) condition (n=152)|||participants|||Number
2570874|NCT02522624|Secondary|Improvements in HILM 2 (Health Insurance Literacy Measure)|"Assessed confidence understanding terms.Improvement in HILM was defined as moving from not confident pre-intervention to a little confident or very confident post-intervention, or from a little confident pre-intervention to very confident post-intervention."|Pre-intervention and post-intervention|One participant in healthcare.gov (Control) condition did not finish HILM (n=162)|||participants|||Number
2570875|NCT02522624|Secondary|Improvements in HILM 1 (Health Insurance Literacy Measure)|"Assessed confidence estimating costs of care.Improvement in HILM was defined as moving from not confident pre-intervention to a little confident or very confident post-intervention, or from a little confident pre-intervention to very confident post-intervention."|Pre-intervention and post-intervention|One participant in healthcare.gov (Control) condition did not finish HILM (n=162)|||participants|||Number
2570876|NCT02522624|Primary|Confidence in Choice|The 4-item SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) decisional conflict scale assessed confidence in plan choice. Each item could be answered dichotomously (1=yes; 0=no). Responses were summed and a group average was obtained. Higher SURE values indicate more confidence in choice. The scale ranged from 0-4.|Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.||||units on a scale||Standard Deviation|Mean
2570877|NCT02522624|Primary|Decision Self-efficacy|The decision self-efficacy (DSE) scale measured participants' perceived ability to understand insurance info and resist unwanted decision pressure. The 6 items on the DSE scale were each rated on a 3-point scale (0=Not confident; 2=A little confident; 4=Very confident). The sum of the DSE items was divided by 6 and multiplied by 25 to obtain a score on a 0-100 scale. Higher values indicate more confidence in one's decision-making ability.|Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.||||units on a scale||Standard Deviation|Mean
2570878|NCT02522624|Primary|Knowledge Score (% Correct)|8 questions developed in researchers' past work. Assessed health insurance knowledge.|Completed immediately after reviewing Decision Aid tool, taking about 5 minutes to complete.||||percentage of 8 items correctly answered||Standard Deviation|Mean
2570879|NCT02522442|Secondary|Functional Outcomes of Sleep Quality|Functional Outcomes of Sleep Quality consists of 30 questions related to the effects of fatigue on daily activities, the instrument was designed to evaluate the respondent's quality of life as it relates to disorders of excessive sleepiness. Five domains of day-to-day life are examined: activity levels, vigilance, intimacy and sexual relationships, productivity, and social outcomes. The participants answer on a scale of 0-4: 0 -I don't do this activity for other reasons,1-Yes, extreme, 2-Yes, moderate, 3-Yes, a little, 4-No. Scores can range 0-120, the lower the score the more tired or sleepy the participant is.|Assessed at Baseline, Day 30 and Day 90||||units on a scale||Standard Deviation|Mean
2570880|NCT02522442|Secondary|Fatigue Severity Scale|The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Participants answer questions on a scale of 1-7, 1 being Strongly Disagree and 7 being Strongly Agree. The scores can range from 9-63. The higher the score the higher the fatigue.|Assessed at Baseline, Day 30 and Day 90||||units on a scale||Standard Deviation|Mean
2570881|NCT02522442|Secondary|Epworth Sleepiness Scale|The Epworth Sleepiness Scale is an 8 item questionnaire that measures the general level of daytime sleepiness. Participants were asked what the chance is they would doze off or fall asleep during different routine daytime situations. The survey answers questions on a scale of 0 to 3- 0 being no chance and 3 being a high chance of dozing. The lowest score possible is a 0 and the highest score possible is a 24.|Assessed at Baseline, Day 30 and Day 90||||units on a scale||Standard Deviation|Mean
2570882|NCT02522442|Primary|Percentage of Group Compliance of the Auto Bilevel Group Compared to the CPAP Group|"Percentage of Group Compliance was compared between AutoBiLevel Group and the CPAP group by measuring proportion of adherent users over the treatment period. Patients with compliance of at least four hours will be classified as compliant and those with less than four hours will be classified as non-compliant. The % of compliant patients will be calculated using the cumulative number of hours on therapy divided by the total number of days of the investigation for each subject."|90 days|One randomized participant discontinued the study early (auto-bilevel Group). One participant in the CPAP group used therapy the first night and failed for the remainder of the study but completed all study visits.|||percentage of compliant users|||Number
2570955|NCT02521376|Primary|Pharmacokinetic (PK) Parameter: Cmax of ENTO|Cmax is defined as the maximum concentration of drug.|0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60, 72, 84, and 96 hours postdose on Day 5|Participants in the PK Analysis Set with available data were analyzed. Healthy control participants may participate in more than one cohorts.|||ng/mL||Standard Deviation|Mean
2570888|NCT02522377|Secondary|Controlled Oral Word Association Test (COWAT) at Last Infusion|This is a verbal fluency measure. Outcome is the count of words that meet criteria within 1 minute, so the minimum is 0 and no fixed maximum exists. Higher scores reflect a better outcome.|visit 17|Analysis was performed on all patients using a mixed effect model. Maximum likelihood estimation allowed for inclusion of all patients, even when loss to follow-up or remission occurred.|||number of words||Standard Error|Mean
2570889|NCT02522377|Secondary|Hopkins Verbal Learning Test - Revised (HVLT-R) at Last Infusion|The number of words remembered are recorded. Scores range from 0 to 12 with higher scores reflecting better acquisition.|visit 17|Analysis was performed on all patients using a mixed effect model. Maximum likelihood estimation allowed for inclusion of all patients, even when loss to follow-up or remission occurred.|||score on a scale||Standard Error|Mean
2570890|NCT02522377|Secondary|Montreal Cognitive Assessment (MOCA) at Last Infusion|MoCA scores range between 0 and 30. Higher scores reflect higher cognition.|visit 17|Analysis was performed on all patients using a mixed effect model. Maximum likelihood estimation allowed for inclusion of all patients, even when loss to follow-up or remission occurred.|||score on a scale||Standard Error|Mean
2570891|NCT02522377|Primary|Montgomery Asberg Depression Rating Scale (MADRS) at Last Infusion|Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60|visit 17|Analysis was performed using mixed effect models. Maximum likelihood estimation allowed inclusion of all patients in analysis.|||score on a scale||Standard Error|Mean
2570892|NCT02522377|Primary|Hamilton Depression Rating Scale (HAMD-17) at Last Infusion|Change in HAMD-17 at Infusion 6. Scores range from 0 to 50, with higher scores representing more depression.|visit 17|Analysis was performed on all patients using a mixed effect model. Maximum likelihood estimation allowed for inclusion of all patients, even when loss to follow-up or remission occurred.|||score on a scale||Standard Error|Mean
2570893|NCT02522325|Primary|Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative|The reinforcing effects of cocaine were determined using a modified progressive ratio procedure in which subjects made 10 choices between a portion of each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both phendimetrazine and placebo maintenance.|After at least seven days of maintenance placebo or target phendimetrazine dose||||Cocaine Choices||Standard Error|Mean
2570894|NCT02522299|Secondary|Trough Concentration Following Administration of NEMI|Blood samples for pharmacokinetic (PK) analysis was collected at the indicated time points following administration of NEMI via DISKUS and ELLIPTA.|Day 1: 24 Hours post-dose; Days 12, 28, 56, 84: Pre-dose|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2570895|NCT02522299|Secondary|Maximum Plasma Concentration (Cmax) Following Administration of NEMI|Blood samples for pharmacokinetic (PK) analysis was collected at the indicated time points following administration of NEMI via DISKUS and ELLIPTA.|Day 1: 5 minutes Post-dose on Day 1|Pharmacokinetic Population comprised of participants in all subject population for whom a pharmacokinetic sample was obtained and analyzed.|||Picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2570896|NCT02522299|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is any untoward medical occurrence in a clinical investigation participant, or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward medical occurrence that at any dose, resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, is associated with liver injury and impaired liver function or any other situation according to medical or scientific judgment was categorized as SAE. Number of participants with AEs and SAEs have been reported.|Up to 14 weeks|All Subjects Population.|||Participants|||Count of Participants
2570897|NCT02522299|Secondary|Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings|A Single 12-lead ECGs was obtained at screening and at each other timepoint during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF) intervals. Data for number of participants with worst case post-Baseline abnormal ECG findings was reported. The value at Screening was considered as Baseline.|Up to 14 weeks|All Subjects Population.|||Participants|||Count of Participants
2570898|NCT02522299|Secondary|Number of Participants With Worst Case Vital Sign Results Relative to Potential Clinical Importance (PCI) Criteria Post-Baseline Relative to Baseline|Vital signs were measured in semi-supine position after 5 minutes rest and included Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Heart rate (HR). Data for number of participants with Post-Baseline worst case Vital Sign results relative to PCI Criteria relative to Baseline was presented. PCI ranges were: SBP (lower: <85 and upper: >160 mmHg), DBP (lower: <45 and upper: >100 mmHg), and HR (lower: <40 and upper: >110 bpm). The value at Screening was considered as Baseline.|Baseline (Screening) and up to 14 weeks|All Subjects Population.|||Participants|||Count of Participants
2570899|NCT02522299|Secondary|Number of Participants With Worst Case Chemistry Results Post-Baseline Relative to Baseline|Blood samples were collected to analyze the following Chemistry parameters: Albumin, Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Direct Bilirubin, Total Bilirubin, Calcium, C-Reactive protein, Creatinine, Glucose, Potassium, Sodium, Total Protein and Urea/Blood urea nitrogen. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose lab value category was unchanged e.g. High to High), or whose value became normal, were not recorded. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. The value at Screening was considered as Baseline. Data for Worst Case Laboratory chemistry values Post-Baseline Relative to Baseline has been presented.|Baseline (Screening) and up to 14 weeks|All Subjects Population.|||Participants|||Count of Participants
2571070|NCT02520310|Secondary|Cardiac Output (CO)|Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min||Standard Deviation|Mean
2570900|NCT02522299|Secondary|Number of Participants With Worst Case Hematology Results Post-Baseline Relative to Baseline|Blood samples were collected to analyze the following s hematology parameters: Hemoglobin, Hematocrit, Mean Corpuscle Hemoglobin (MCH), Mean Corpuscle Volume (MCV), Platelet count, Red Blood Cell (RBC) count, White Blood Cell (WBC) count, Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. Participants were counted in the worst case category that their value changes to (low or high), unless there is no change in their category. Participants whose lab value category was unchanged (example given [e.g.],High to High), or whose value became normal, were not recorded. Participants were counted twice if the participant had values that changed 'To Low' and 'To High', so the percentages may not add to 100%. The value at Screening was considered as Baseline. Data for Worst Case Laboratory Hematology values Post-Baseline Relative to Baseline has been presented.|Baseline (Screening) and up to 14 weeks|All Subjects Population.|||Participants|||Count of Participants
2570901|NCT02522299|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC)|FEV1 is the volume of air that can forcibly be blown out in one second. A triplicate FEV1 measurement were taken daily in the morning before dose administration using the site's spirometer as soon as it was safe to do so. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Baseline is the latest available measurement from Day 2 Within 48 hours /discharge (On Treatment) and Day 1 (Pre-Treatment). Change from Baseline is the post-Baseline value minus Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.|Baseline and Days 12, 28, 56, 84|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Liters||Standard Deviation|Mean
2570902|NCT02522299|Secondary|Mean Rescue Medication Free Days|For reliever/rescue use, bronchodilator use recorded in the diary was summarized as the mean number of occasions of rescue use per day, where a rescue-free day was defined as a 24-hour period in which the number of occasions of bronchodilator use was zero. Number of occasions bronchodilator taken in the last 24 hours were collected in the daily diary. The mean number of rescue free days were calculated for each participant during the four weekly periods (Weeks 1 to 4; Weeks 5-8 and Weeks 9-12). The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI. There was no intent to compare two devices.|Weeks 1 to 4; Weeks 5 to 8 and Weeks 9 to 12|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Days||Standard Deviation|Mean
2570903|NCT02522299|Secondary|Mean Number of Occasions of Rescue Usage Per Day|For reliever/rescue use, bronchodilator use recorded in the diary was summarized as the mean number of occasions of rescue use per day.where a rescue-free day was defined as a 24-hour period in which the number of occasions of bronchodilator use was zero. Number of occasions bronchodilator taken in the last 24 hours were collected in the daily diary. The mean number of occasions of rescue use per day, were calculated for each participant during the four weekly periods (Weeks 1 to 4; Weeks 5-8 and Weeks 9-12). The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.|Weeks 1 to 4; Weeks 5 to 8 and Weeks 9 to 12|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Rescue use per day||Standard Deviation|Mean
2570904|NCT02522299|Secondary|Change From Baseline (Average Day 1 to 3) Peak Expiratory Flow (PEF)|PEF measurements were taken (in triplicate) daily in the morning before dose administration, as soon as it is safe for the participant to do so. The best/highest result was recorded. Participants were provided with a handheld device. Baseline here is defined as average of Day 1 to Day 3. Change from Baseline is the post-Baseline value minus the Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI. There was no intent to compare two devices.|Baseline and up to Day 84|All Subjects Population.|||Liters per minute||95% Confidence Interval|Mean
2570905|NCT02522299|Secondary|Change From Baseline in Trachea Length and Diameter at FRC and TLC|Trachea length and diameter was derived from HRCT. It was measured at both FRC and TLC scan conditions. The value at Screening was considered as Baseline. Change from Baseline is the post-Baseline value minus the Baseline value. The change from Baseline data is presented for Day 12 and Day 28 for trachea length and diameter. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.|Baseline (Screening) and Days 12 and 28|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Millimeters||Standard Deviation|Mean
2570906|NCT02522299|Secondary|Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Regions|Change from Baseline in lung lobar volumes was measured at FRC and TLC scan conditions. Data was collected at longitudinal time points: Baseline (Screening), Day 12 and Day 28. At each time point it was measure at 5 Regions (Upper, Lower, Central, Distal & Total). The value at Screening was considered as Baseline. Change from Baseline is the post-Baseline value minus the Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.|Baseline (Screening) and Days 12 and 28|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Liters||95% Confidence Interval|Geometric Mean
2570931|NCT02522286|Primary|Patient Rating of Shared Decision Making|"Responses from CollaboRATE, a 3-question validated patient reported measure of shared decision making. Patients answered questions on a scale of 0 (definitely disagree) to 9 (definitely agree). The CollaboRATE questions are as follows: 1) How much effort was made to help you understand your health issues? 2) How much effort was made to listen to the things that matter most to you about your health issues?, 3) How much effort was made to include what matters most to you in choosing what to do next? The outcome measure was the percent of patients who gave the top score of 9 on all three questions."|Day 1 (outcomes measures were assessed once for each participant)||||percentage of participants||Standard Deviation|Mean
2570907|NCT02522299|Secondary|Change From Baseline in Lung Lobar Volume (iVlobe) at FRC and TLC for Individual Lobes|Change from Baseline in lung lobar volumes was measured at FRC and TLC scan conditions. Data was collected at longitudinal time points: Baseline (Screening), Day 12 and Day 28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe). The value at Screening was considered as Baseline. Change from baseline is the post-Baseline value minus the Baseline value. The study had a protocol amendment to reflect changes in manufacturing device from DISKUS to ELLIPTA after study had been initiated, but the 2 treatment arms remained the same i.e. Placebo and NEMI.There was no intent to compare two devices.|Baseline (Screening) and Days 12 and 28|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Liters||95% Confidence Interval|Geometric Mean
2570908|NCT02522299|Secondary|Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions at Day 28|siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.|Baseline (Day 12) and Day 28|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||kPa*s||95% Confidence Interval|Geometric Mean
2570909|NCT02522299|Secondary|Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Regions|siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.|Baseline (Screening) and Days 12 and 28|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||kPa*s||95% Confidence Interval|Geometric Mean
2570910|NCT02522299|Secondary|Change From Baseline (Day 12) in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes at Day 28|siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.|Baseline (Day 12) and Day 28|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||kPa*s||95% Confidence Interval|Geometric Mean
2570911|NCT02522299|Secondary|Change From Baseline in Specific Imaging Airway Resistance (siRaw) at FRC and TLC for Individual Lobes|siRaw is a measure of the resistance in an individual's airway corrected for their lobar volume derived from the HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analysed (represented by n=X1, X2 in the category title). This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.|Baseline (Screening) and Days 12 and 28|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||kPa*s||95% Confidence Interval|Geometric Mean
2570912|NCT02522299|Secondary|Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Regions at Day 28|iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.|Baseline (Day 12) and Day 28|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||kPa*s/L||95% Confidence Interval|Geometric Mean
2570932|NCT02521948|Secondary|Time to Hemostasis|The elapsed time between MANTA deployment (withdrawal of sheath from artery) and first observed and confirmed arterial hemostasis (no or minimal subcutaneous oozing and the absence of expanding or developing hematoma).|Time between MANTA deployment and first observed and confirmed arterial hemostasis up to ten (10) minutes after MANTA device is deployed.||||minutes||Standard Deviation|Mean
2574280|NCT02484898|Primary|Diagnostic Yield of the SEEQ™ MCT/ECM System||120 Days|Subjects prescribed the SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias|||percentage of subjects with CRA||95% Confidence Interval|Number
2570913|NCT02522299|Secondary|Change From Baseline in iRaw at FRC and TLC for Individual Regions|iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.|Baseline (Screening) and Days 12 and 28|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||kPa*s/L||95% Confidence Interval|Geometric Mean
2570914|NCT02522299|Secondary|Change From Baseline (Day 12) in iRaw at FRC and TLC for Individual Lobes at Day 28|iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.|Baseline (Day 12) and Day 28|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||kPa*s/L||95% Confidence Interval|Geometric Mean
2570915|NCT02522299|Secondary|Change From Baseline in Imaging Airway Resistance (iRaw) at FRC and TLC for Individual Lobes|iRaw is a measure of the resistance in an individual's airway derived from HRCT. It was measured at FRC and TLC. Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). • This table presents the SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.|Baseline (Screening) and Days 12 and 28|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Kilopascal* seconds per liter (kPa*s/L)||95% Confidence Interval|Geometric Mean
2570916|NCT02522299|Secondary|Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Regions at Day 28|iVaw is a measure of the volume in an individual's airway derived from the HRCT. It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.|Baseline (Day 12) and Day 28|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Milliliters||95% Confidence Interval|Geometric Mean
2570917|NCT02522299|Secondary|Change From Baseline in iVaw at FRC and TLC for Individual Regions|iVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.|Baseline (Screening) and Days 12 and 28|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Milliliters||95% Confidence Interval|Geometric Mean
2570918|NCT02522299|Secondary|Change From Baseline (Day 12) in iVaw at FRC and TLC for Individual Lobes at Day 28|iVaw is a measure of the volume in an individual's airway derived from the HRCT. It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.|Baseline (Day 12) and Day 28|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Milliliters||95% Confidence Interval|Geometric Mean
2570933|NCT02521948|Primary|Hemostasis Success|Hemostasis at the puncture site within 10 minutes of cutting the MANTA suture without need for manual or mechanical compression and without later re-bleeding (trivial or subcutaneous oozing will not be considered bleeding; light finger pressure to control subcutaneous oozing will not be considered manual compression)|Within the first 10 minutes of cutting the MANTA suture||||Participants|||Count of Participants
2570919|NCT02522299|Secondary|Change From Baseline in Imaging Airway Volume (iVaw) at FRC and TLC for Individual Lobes|iVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.|Baseline (Screening) and Days 12 and 28|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Milliliters||95% Confidence Interval|Geometric Mean
2570920|NCT02522299|Secondary|Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Regions at Day 28|siVaw is a measure of the volume in an individual's airway corrected for their lobar volume derived from the high resolution computed tomography (HRCT). It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.|Baseline (Day 12) and Day 28|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Milliliters per Liter||95% Confidence Interval|Geometric Mean
2570921|NCT02522299|Secondary|Change From Baseline in siVaw at FRC and TLC for Individual Regions|siVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title).This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.|Baseline (Screening), Days 12 and 28|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Milliliters per Liter||95% Confidence Interval|Geometric Mean
2570922|NCT02522299|Secondary|Change From Baseline (Day 12) in siVaw at FRC and TLC for Individual Lobes at Day 28|siVaw is a measure of the volume in an individual's airway corrected for their lobar volume derived from the high resolution computed tomography (HRCT). It was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (represented by n=X1, X2 in the category title). This table presents the D12D28 scan trim pair data only.|Baseline (Day 12) and Day 28|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Milliliters per Liter||95% Confidence Interval|Geometric Mean
2570923|NCT02522299|Secondary|Change From Baseline in Specific Imaging Airway Volume (siVaw) at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) for Individual Lobes|siVaw was measured at FRC and TLC. Data was collected at longitudinal time points (Untrimmed data): Baseline (Screening), Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (right upper lobe, left upper lobe, right middle lobe, right lower lobe & left lower lobe) and 5 Regions (Upper, Lower, Central, Distal & Total). For Untrimmed data and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only participants available at the specified time point were analyzed (n=X1, X2 in the category title). This table presents the untrimmed data (in rows with categories containing untrimmed), SCRD12 scan trim pair data (in rows with categories containing Scan Trimmed and Day 12) and SCRD28 scan trim pair data (in rows with categories containing Scan Trimmed and Day 28) only.|Baseline (Screening), Days 12 and 28|All Subjects Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Milliliters per Liter||95% Confidence Interval|Geometric Mean
2570934|NCT02521948|Primary|Number of Participants With Major Complications|"Composite endpoint that includes any of the following adverse events:~Access site-related bleeding requiring blood transfusion or vascular repair~Vascular injury requiring repair (e.g. perforation, dissection, arterio-venous fistula, retroperitoneal bleed, pseudoaneurysm)~Femoral artery stenosis at the access site requiring intervention~New ipsilateral lower extremity ischemia causing a threat to the viability of the limb~Access site-related infection requiring intravenous antibiotics and/or extended hospitalization~New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair~Permanent access site-related nerve injury (lasting>30 days)"|Within either the first 30 days (plus or minus 7 days) after the procedure or the first 60 days (plus or minus 14 days) after the procedure||||Participants|||Count of Participants
2570924|NCT02522299|Primary|Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in All NEMI/All Placebo Comparison Treatment Group|Saline-induced sputum samples were collected at the indicated time-points to determine the alterations in previously identified immune cell mechanisms specifically related to neutrophil function by identifying the changes in mRNA transcriptome in induced sputum. For each probe set, the log2 transformed mRNA intensities were analyzed in separate repeated measures models. The models included a Treatment, Visit and Treatment*Visit term. The Visit consisted of 4 levels: Screening (Baseline), Day 12, Day 28 and Day 84, and the Treatment consisted of three levels: Null (when Visit = Screening), All Placebo and All NEMI. The fold changes were derived from the back transformed ratio from Baselines as fold change = ratio if ratio is >=1, else if ratio <1 then fold change = -1/ratio. Data for pre-specified probe sets that meet the criteria fold change >1.5 and p<0.05 for All NEMI, All Placebo and All NEMI/All Placebo group is presented in outcome measure 1, 2 and 3 respectively.|Baseline (Screening) and Days 12, 28 and 84|All Subjects Population.|||Fold Change|||Number
2570925|NCT02522299|Primary|Change in mRNA Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in Placebo Treatment Group|Saline-induced sputum samples were collected at the indicated time-points to determine the alterations in previously identified immune cell mechanisms specifically related to neutrophil function by identifying the changes in mRNA transcriptome in induced sputum. Baseline was defined as screening visit. The log2 transformed mRNA intensities for each probe set were analysed in a separate repeated measures model. Back transformed baseline-adjusted ratios and two-sided unadjusted p-values were calculated for each visit as the specified time-point value/baseline value. These ratios were converted to fold change values; if ratio >= 1 then fold change=ratio or if ratio < 1 then fold change = -1/ratio. Data for pre-specified probe sets that meet the criteria fold change >1.5 or <-1.5 and p<0.05 for All NEMI, All Placebo and All NEMI/All Placebo group is presented in outcome measure 1, 2 and 3 respectively. In the categories column we have included time-point, Probe ID and Gene label.|Baseline (Screening) and Days 12, 28 and 84|All Subjects Population.|||Fold Change|||Number
2570926|NCT02522299|Primary|Change in Messenger Ribonucleic Acid (mRNA) Transcriptome in Induced Sputum After 12, 28 and 84 Days of Treatment (Selected Probe Sets With Fold Change >1.5 or <-1.5 and p<0.05) in NEMI Treatment Group|Saline-induced sputum samples were collected at the indicated time-points to determine the alterations in previously identified immune cell mechanisms specifically related to neutrophil function by identifying the changes in mRNA transcriptome in induced sputum. Baseline was defined as screening visit. The log2 transformed mRNA intensities for each probe set were analyzed in a separate repeated measures model. Back transformed baseline-adjusted ratios and two-sided unadjusted p-values were calculated for each visit as the specified time-point value/baseline value. These ratios were converted to fold change values; if ratio >= 1 then fold change=ratio or if ratio < 1 then fold change = -1/ratio. Data for pre-specified probe sets that meet the criteria fold change >1.5 or <-1.5 and p<0.05 for All NEMI, All Placebo and All NEMI/All Placebo group is presented in outcome measure 1, 2 and 3 respectively. In the categories column we have included time-point, Probe ID and Gene label.|Baseline (Screening) and Days 12, 28 and 84|All Subjects Population comprised of all randomized participants who received at least one dose of the study treatment.|||Fold change|||Number
2570927|NCT02522286|Secondary|Option 5 Shared Decision Making Score|"Researchers measured the shared decision making process that occurs between patients and physicians during the appointment using a method called OPTION5. Researchers listened to audio-recorded patient appointments, identified any topic, defined as a health issue where alternate treatment or management option exist/where the need for a decision exists, and then measured each topic for each of the OPTION5 items on a scale of 0 (no effort: nothing observed or heard) to 20 (exemplary effort: excellent, careful attention to communication around the ideas and issues, with checks on understanding, for each of the 5 items described below. The total score is a sum of the scores from each of the 5 items at the clinic.~Item 1: presenting options Item 2: establishing a partnership with the patient Item 3: describing pros and cons of options Item 4: eliciting patient preferences Item 5: integrating patient preferences into the decision"|Day 1 (outcomes measures were assessed once for each participant based on analysis of the audio recording of their visits)|From the 75 patients at each of the 4 clinics, 10 appointments were randomly selected to be audio-recordinged. The Number of Participants Analyzed reflects the number of topics identified from the 10 recordings at each clinic.|||scores on a scale||Standard Deviation|Mean
2570928|NCT02522286|Primary|Patients' Feeling of Respect by Their Doctor|"Patient responses to one statement modified from Consumer Assessment of Healthcare Providers and Systems (CAHPS) regarding the respect they felt from their doctor. Patients rated the statement My doctor showed respect for what I had to say, on a scale of 1 (definitely disagree) to 4 (definitely agree). The outcome measure was the percentage of patients that gave the top score of 4 on this statement."|Day 1 (outcomes measures were assessed once for each participant)||||percentage of participants||Standard Deviation|Mean
2570929|NCT02522286|Primary|Patient Responses to Stakeholder Generated Questions|"Patient responses to statements that were generated by the study's patient and physicians stakeholders regarding how they felt during their appointment. Patients rated 5 statements, described below, on a scale of 0 (definitely disagree) to 9 (definitely agree). The outcome measure is the percent of patients that responded with a top score of 9. Statement 1: My doctor and I accomplished my most important goals today. Statement 2: I feel cared for. Statement 3: I feel comfortable being open with my doctor. Statement 4: I felt my doctor was open with me. Statement 5: I know what my next steps are."|Day 1 (outcomes measures were assessed once for each participant)||||percentage of participants||Standard Deviation|Mean
2570930|NCT02522286|Primary|Doctor Facilitation Subscale of the Perceived Involvement in Care Scale|"Responses from this patient reported measure regarding their attitudes of doctor facilitation of patient involvement for their illness management. Patients rated 5 statements on a scale of 0 (definitely disagree) to 9 (definitely agree). The statements are as follows: 1) My doctor encouraged me to talk about personal concerns related to my medical symptoms, 2) My doctor asked me what I believe is causing my medical symptoms, 3) My doctor gave me a complete explanation for my medical symptoms or treatment, 4) My doctor encouraged me to give my opinion about my medical treatment, 5) My doctor asked me whether I agree with his/her decisions. The outcome measure was the percent of patients who gave the top score of 9 on all five statements."|Day 1 (outcomes measures were assessed once for each participant)||||percentage of participants||Standard Deviation|Mean
2570935|NCT02521766|Primary|Mesopic Best Corrected Distance Visual Acuity (mBCDVA) (With and Without Glare) (Letters Read) at Study Visit - All HMIOL Cohort|VA was assessed using the ETDRS-Fast method under mesopic (dimly lit) conditions at a distance of 4 m with the correction obtained from manifest refraction testing. Testing was performed with and without glare. Chart luminance was set to 3 cd/m2. mBCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye, All HMIOL Cohort only. No formal statistical hypothesis testing was planned.|Month 3 postoperative|Per Protocol Population, with available data at the visit|||letters|eyes|Standard Deviation|Mean
2570936|NCT02521766|Primary|Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2|VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye, Cohort 2 only. No formal statistical hypothesis testing was planned.|Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange|Per Protocol Population, with available data at the visit|||percentage of eyes|eyes||Number
2570937|NCT02521766|Primary|Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye|VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned.|Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative|Per Protocol Population, with available data at the visit|||letters|eyes|Standard Deviation|Mean
2570938|NCT02521766|Primary|Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2|VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.|Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exch|Per Protocol Population, with available data at the visit|||letters|eyes|Standard Deviation|Mean
2570939|NCT02521766|Primary|Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1|VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.|Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative|Per Protocol Population, with available data at the visit|||letters|eyes|Standard Deviation|Mean
2570940|NCT02521766|Primary|Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - All HMIOL Cohort|VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.|Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative|Per Protocol Population, with available data at the visit|||letters|eyes|Standard Deviation|Mean
2570941|NCT02521766|Primary|Mean BCDVA (Letters Read) by Study Visit - Fellow Eye|VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was rrecorded in letters read correctly. This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned.|Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 12 postoperative|Per Protocol Population, with available data at the visit|||letters|eyes|Standard Deviation|Mean
2570942|NCT02521766|Primary|Mean BCDVA (Letters Read) by Study Visit - Cohort 2|VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Month 1 postoperative and Month 3 postoperative visits were pre-optic exchange.This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.|Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange|Per Protocol Population, with available data at the visit|||letters|eyes|Standard Deviation|Mean
2570943|NCT02521766|Primary|Mean BCDVA (Letters Read) by Study Visit - Cohort 1|VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.|Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative|Per Protocol Population, with available data at the visit|||letters|eyes|Standard Deviation|Mean
2570944|NCT02521766|Primary|Mean BCDVA (Letters Read) by Study Visit - All HMIOL Cohort|VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.|Day -90 to Day -1 preoperative, Month 1 postoperative, Month 3 postoperative|Per Protocol Population, with available data at the visit|||letters|eyes|Standard Deviation|Mean
2572327|NCT02508116|Primary|The Number (Percentage) of Participants Receiving Prasugrel/Ticagrelor|The number (percentage) of participants receiving prasugrel/ticagrelor in each randomized arm|for up to 7 days after PCI|Intent to treat|||Participants|||Count of Participants
2570945|NCT02521766|Primary|Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye|A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned.|Month 1 postoperative, Month 3 postoperative, Month 12 postoperative|Per Protocol Population, with available data at the visit|||percentage of eyes|eyes||Number
2570946|NCT02521766|Primary|Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2|A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.|Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange|Per Protocol Population, with available data at the visit|||percentage of eyes|eyes||Number
2570947|NCT02521766|Primary|Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1|A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.|Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative|Per Protocol Population, with available data at the visit|||percentage of eyes|eyes||Number
2570948|NCT02521766|Primary|Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort|A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.|Week 1 postoperative, Month 1 postoperative, Month 3 postoperative|Per Protocol Population, with available data at the visit|||percentage of eyes|eyes||Number
2570949|NCT02521766|Primary|Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Fellow Eye|VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.|Month 1 postoperative, Month 3 postoperative, Month 12 postoperative|Per Protocol Population, with available data at the visit|||percentage of eyes|eyes||Number
2570950|NCT02521766|Primary|Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2|VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Month 1 postoperative and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned|Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange|Per Protocol Population, with available data at the visit|||percentage of eyes|eyes||Number
2570951|NCT02521766|Primary|Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 1|VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.|Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative|Per Protocol Population, with available data at the visit|||percentage of eyes|eyes||Number
2570952|NCT02521766|Primary|Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - All HMIOL Cohort|Visual acuity (VA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS)-Fast method under well-lit conditions at a distance of 4 meters (m) with the correction obtained from manifest refraction testing. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.|Month 1 postoperative, Month 3 postoperative|Per Protocol Population, with available data at the visit|||percentage of eyes|eyes||Number
2570953|NCT02521376|Secondary|Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities|Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each subject.|Baseline up to Day 9 plus 30 days|Participants in the Safety Analysis Set were analyzed.|||percentage of participants|||Number
2570954|NCT02521376|Secondary|Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)|"TEAEs are defined as events that meet one of the following criteria:~Any adverse events (AEs) with onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or~Any AEs leading to premature discontinuation of study drug."|Baseline up to Day 9 plus 30 days|Safety Analysis Set included all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
2570956|NCT02521376|Primary|Pharmacokinetic (PK) Parameter: AUCtau of ENTO|AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).|0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60, 72, 84, and 96 hours postdose on Day 5|Participants in the PK Analysis Set (all enrolled participants who received at least one dose of ENTO and had at least one evaluable PK concentration data value reported by the PK lab) with available data were analyzed. Healthy control participants may participate in more than one cohorts.|||h*ng/mL||Standard Deviation|Mean
2570957|NCT02521259|Primary|the Pediatric Anesthesia Emergence Delirium (PAED) Score|Evaluating the Pediatric Anesthesia Emergence Delirium (PAED) score 3 times at the post-anesthetic care unit (PACU): when participant arrived at PACU, measure the PAED score (from 0 to 20; the higher score indicates the severer emergenct agitation) immediately and if the score is 10 or over 10, give the participant Fentanyl 1mcg/kg. Repeat checking the PAED score 2 times more with 15 minutes interval.|30 minutes||||score on a scale||Standard Deviation|Mean
2570958|NCT02520726|Secondary|Beck Scale for Suicide Ideation||1 month|All subjects lost to follow-up||||||
2570959|NCT02520726|Primary|Clinician-Administered PTSD Scale||Month|All subjects lost to follow-up||||||
2570960|NCT02520531|Secondary|EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire|The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health.|pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up|Because some patients missed to attend some visits as well as early termination cases, the numbers in some follow-ups differ from number analyzed.|||units on a scale||Standard Deviation|Mean
2570961|NCT02520531|Secondary|WOMAC Patient Questionnaire|The WOMAC collects information specific to osteoarthritis outcomes. The patient response questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and function. Each question is scored from 0 to 4 for each set of factors, with 0 indicating no pain, stiffness, or limited in function, and 4 indicating extreme pain stiffness, or limited in function. Total WOMAC scores range from 0 to 96 wit lower values representing better outcomes.|pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up|Because some patients missed to attend some visits as well as early termination cases, the numbers in some follow-ups differ from number analyzed.|||units on a scale||Standard Deviation|Mean
2570962|NCT02520531|Secondary|Chair Raise Test|A measurement to assess functional lower extremity strength. The participant is seated on a chair. Arms are crossed at the wrists and held against the chest. The participant is instructed to arise from an adjustable chair with the knees in a 90 degree angle (measurement with Goniometer) without using arms.|pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up|In some cases it was missed to do the Chair rise test.|||Participants|||Count of Participants
2570963|NCT02520531|Secondary|Knee Society Score (KSS)|"The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up|Because some patients missed to attend some visits as well as early termination cases, the numbers in some follow-ups differ from number analyzed|||units on a scale||Standard Deviation|Mean
2570964|NCT02520531|Primary|Comparison of Maximum Passive and Active Flexion.|"Comparison of maximum flexion, both passive and active between Scorpio NRG PS knee prosthesis and the Scorpio PS knee prosthesis.~The active flexion-tolerated range is greater/equal 70 degree. The passive flexion-tolerated range is greater/equal 80 degree. The Hyperextension tolerated range is 0 to 10 degree. Higher scores mean a better outcome."|5 years follow-up|At the 5 years follow-up data of 36 participants per study arm were analyzed.|||degree||Standard Deviation|Mean
2570965|NCT02520518|Primary|Change From Baseline in Satiety Hormone Insulin at Week 12|Will be analyzed using a commercially available biochemical assay.|Baseline, 12 weeks|Data were not collected.||||||
2570966|NCT02520518|Primary|Change From Baseline in Satiety Hormone Leptin at Week 12|Will be analyzed using a commercially available biochemical assay.|Baseline, 12 weeks|Data were not collected.||||||
2570967|NCT02520518|Primary|Change From Baseline in Maker of Oxidative Stress (Low Density Thiobarbituric Acid Reactive Substances) at Week 12|Will be analyzed using a commercially available biochemical assay.|Baseline, 12 weeks|Data were not collected.||||||
2570968|NCT02520518|Primary|Change From Baseline in Maker of Oxidative Stress (Oxidized Low Density Lipoprotein) at Week 12|Will be analyzed using a commercially available biochemical assay.|Baseline, 12 weeks|Data were not collected.||||||
2570969|NCT02520518|Primary|Change From Baseline in Hunger Hormone Peptide Tyrosine Tyrosine at Week 12|Will be analyzed using a commercially available biochemical assay.|Baseline, 12 weeks|Data were not collected.||||||
2570970|NCT02520518|Primary|Change From Baseline in Hunger Hormone Ghrelin at Week 12|Will be analyzed using a commercially available biochemical assay.|Baseline, 12 weeks|Data were not collected.||||||
2570971|NCT02520518|Primary|Change From Baseline in Marker of Inflammation (Interleukin 6) at Week 12|Will be analyzed using a commercially available biochemical assay.|Baseline, 12 weeks|Data collection was not performed||||||
2570972|NCT02520518|Primary|Change From Baseline in Marker of Inflammation (Tumor Necrosis Factor Alpha) at Week 12|Will be analyzed using a commercially available biochemical assay.|Baseline, 12 weeks|Data collection was not performed||||||
2570973|NCT02520518|Primary|Change From Baseline in Marker of Inflammation (High Sensitive C-reactive Protein) at Week 12|Will be analyzed using a commercially available biochemical assay.|Baseline, 12 weeks|Data were not collected.||||||
2571071|NCT02520310|Secondary|Cardiac Output (CO)|Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.|At baseline (Within 14 days prior to the AVJ-514 procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||L/min||Standard Deviation|Mean
2571072|NCT02520310|Secondary|Forward Stroke Volume (FSV)||5 years|||||||
2570974|NCT02520518|Primary|Change From Baseline in Perception of Hunger at Week 12|Perceptions of Hunger will be determined using a visual analog scale called a Hunger Rating Scales. The minimum value is 1 (not at all hungry) and the maximum value is 100 (very hungry). One value between 1 and 100 is reported by the participant dependent on their perception. No sub scores are used. The perceived values are reported as the group average at baseline and 12 weeks. There is not a better or worse outcome, but rather a measure of perceived hunger. If Dapagliflozin were effective at decreasing hunger, respondents would exhibit 12-week scores for the question in comparison to their baseline scores.|Baseline, 12 weeks||||score on a scale||Standard Deviation|Mean
2570975|NCT02520518|Primary|Change From Baseline in Perception of Satiety at Week 12|Perceptions of satiety will be determined using a visual analog scale called a Hunger Rating Scales. The minimum value is 1 (not at all full) and the maximum value is 100 (extremely full). One value between 1 and 100 is reported by the participant dependent on their perception. No sub scores are used. The perceived values are reported as the group average at baseline and 12 weeks. There is not a better or worse outcome, but rather a measure of perceived satiety. If Dapagliflozin were effective at increasing fullness, respondents would exhibit 12-week scores for the question in comparison to their baseline scores.|Baseline, 12 weeks||||score on a scale||Standard Deviation|Mean
2570976|NCT02520518|Primary|Change From Baseline in Blood Pressure at Week 12||Baseline, 12 weeks||||mmHg||Standard Deviation|Mean
2570977|NCT02520518|Primary|Change From Baseline in Insulin Sensitivity at Week 12|Via oral glucose tolerance test.|Baseline,12 weeks|Data were not collected.||||||
2570978|NCT02520414|Primary|Safety Profile of the Symphion® Bipolar Hysteroscopic Tissue Resection System When Used in the Office Setting for the Removal of Intracavitary Polyps and Myomas.|Absence of device related adverse events, or death.|2 weeks||||percentage of participants|||Number
2570979|NCT02520388|Secondary|Before School Functioning Questionnaire (BSFQ) Total Score|The BSFQ was developed as a hybrid measure completed by a clinician or parent/legal guardian to assess commonly reported areas of morning dysfunction - both behaviors and functions associated with the post-waking, early morning period (from approximately 6:00 am to 9:00 am) - in children and adolescents with ADHD (Wilens et al., 2010; Wilens et al., 2013). Symptom severity and functional impairment were rated from 0 (none) to 3 (severe - different from peers all days, all settings) with total scores ranging from 0 to 60. Ratings were completed by a site clinician (MD, PhD, DO, licensed social worker, or trained mental health professional approved by the sponsor) at Visits 2 through 5 using a structured interview format.|Last week of 3-week treatment period assessed at Visit 5.|Intent-to-Treat|||BSFQ total score||Standard Error|Least Squares Mean
2570980|NCT02520388|Primary|Attention Deficit Hyperactivity Disorder Rating Scale Based on DSM-IV Criteria (ADHD-RS-IV) Total Score.|The ADHD-RS-IV was developed to measure the behaviors of children with ADHD (DuPaul et al., 1998). The scale consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored in a range from 0 (reflecting no symptoms or a frequency of never or rarely) to 3 (reflecting severe symptoms or a frequency of almost always), with a range of total scores ranging from 0 to 54. In this study, a site clinican (required to be an MD, PhD, DO, licensed social worker, or any trained mental health professional approved by the sponsor) completed ADHD-RS-IV assessments at each visit using a structured interview format.|Last week of 3-week treatment period assessed at Visit 5.|Intent-to-Treat|||ADHD-RS-IV total score||Standard Error|Least Squares Mean
2570981|NCT02520310|Secondary|Number of Participants With Device Embolization Not Requiring Surgery|Device embolization is defined as detachment of the deployed AVJ-514 device from both mitral leaflets.|1 year|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2570982|NCT02520310|Secondary|Number of Participants With Device Embolization Requiring Surgery|Device embolization is defined as detachment of the deployed AVJ-514 device from both mitral leaflets.|1 year|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2570983|NCT02520310|Secondary|Rate of Heart Failure Hospitalizations in the 1 Year Post-AVJ-514 Procedure Compared to the 1 Year Prior||1 Year Pre and Post Index Procedure|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Rate of HF Hospitalization||95% Confidence Interval|Number
2570984|NCT02520310|Secondary|Number of Participants With Usage of Concomitant Cardiac Medications|Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2570985|NCT02520310|Secondary|Number of Participants With Usage of Concomitant Cardiac Medications|Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2570986|NCT02520310|Secondary|Number of Participants With Usage of Concomitant Cardiac Medications|Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.|30 days|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2570987|NCT02520310|Secondary|Number of Participants With Usage of Concomitant Cardiac Medications|Number of participants with any change in type of medication from baseline to follow-up. Measured in overall counts.|At baseline (Within 14 days prior to the AVJ-514 procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571009|NCT02520310|Secondary|Six Minute Walk Test (6MWT) Distance|The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.|5 years|||||||
2570988|NCT02520310|Secondary|Number of Participants With Major Bleeding|"Major bleeding is defined as bleeding ≥ Type 3 based on a modified Bleeding Academic Research Consortium (BARC) definition.~Type 3:~Type 3a (i) Overt bleeding plus hemoglobin drop of 3 to <5 g/dL* (provided hemoglobin drop is related to bleed) (ii) Any transfusion with overt bleeding~Type 3b (i) Overt bleeding plus hemoglobin drop ≥5 g/dL* (provided hemoglobin drop is related to bleed) (ii) Cardiac tamponade (iii) Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid) (iv) Bleeding requiring intravenous vasoactive agents~Type 3c (i) Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal) (ii) Subcategories confirmed by autopsy or imaging or lumbar puncture (iii) Intraocular bleed compromising vision"|1 year|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2570989|NCT02520310|Secondary|Number of Participants With Major Bleeding|"Major bleeding is defined as bleeding ≥ Type 3 based on a modified Bleeding Academic Research Consortium (BARC) definition.~Type 3:~Type 3a (i) Overt bleeding plus hemoglobin drop of 3 to <5 g/dL* (provided hemoglobin drop is related to bleed) (ii) Any transfusion with overt bleeding~Type 3b (i) Overt bleeding plus hemoglobin drop ≥5 g/dL* (provided hemoglobin drop is related to bleed) (ii) Cardiac tamponade (iii) Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid) (iv) Bleeding requiring intravenous vasoactive agents~Type 3c (i) Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal) (ii) Subcategories confirmed by autopsy or imaging or lumbar puncture (iii) Intraocular bleed compromising vision"|30 days|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2570990|NCT02520310|Secondary|Number of Participants With Clinically Significant ASD That Requires Intervention|Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)|5 years|||||||
2570991|NCT02520310|Secondary|Number of Participants With Clinically Significant ASD That Requires Intervention|Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)|4 years|||||||
2570992|NCT02520310|Secondary|Number of Participants With Clinically Significant ASD That Requires Intervention|Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)|3 years|||||||
2570993|NCT02520310|Secondary|Number of Participants With Clinically Significant ASD That Requires Intervention|Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)|24 months|||||||
2570994|NCT02520310|Secondary|Number of Participants With Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention|Defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention (repair of ASD completed at the time of surgery for other reasons, but not as the primary reason for surgery, is not counted as ASD.)|12 months|||||||
2570995|NCT02520310|Secondary|Mitral Stenosis|Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.|5 years|||||||
2570996|NCT02520310|Secondary|Mitral Stenosis|Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.|4 years|||||||
2570997|NCT02520310|Secondary|Mitral Stenosis|Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.|3 years|||||||
2570998|NCT02520310|Secondary|Mitral Stenosis|Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.|24 months|||||||
2570999|NCT02520310|Secondary|Number of Participants With Mitral Stenosis|Defined as a mitral valve orifice of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory.|1 year|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571000|NCT02520310|Secondary|Number of Hospitalizations||5 years|||||||
2571001|NCT02520310|Secondary|Number of Hospitalizations||4 years|||||||
2571002|NCT02520310|Secondary|Number of Hospitalizations||3 years|||||||
2571003|NCT02520310|Secondary|Number of Hospitalizations||24 months|||||||
2571004|NCT02520310|Secondary|Number of Hospitalizations and Reason for Hospitalization||1 year post index procedure|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2571005|NCT02520310|Secondary|Number of Participants With Additional AVJ-514 Device Intervention|Number of participants with any additional AVJ-514 procedure after the index procedure. Measured per occurrence.|1 year|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571006|NCT02520310|Secondary|Number of Participants With Additional AVJ-514 Device Intervention|Number of participants with any additional AVJ-514 procedure after the index procedure. Measured per occurrence.|30 days|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571007|NCT02520310|Secondary|Number of Participants With Mitral Valve Surgery|Surgical access to repair or replace the mitral valve. Measured per occurrence.|1 year|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571008|NCT02520310|Secondary|Number of Participants With Mitral Valve Surgery|Surgical access to repair or replace the mitral valve. Measured per occurrence.|30 days|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571073|NCT02520310|Secondary|Forward Stroke Volume (FSV)||4 years|||||||
2571010|NCT02520310|Secondary|Six Minute Walk Test (6MWT) Distance|The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.|4 years|||||||
2571011|NCT02520310|Secondary|Six Minute Walk Test (6MWT) Distance|The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.|3 years|||||||
2571012|NCT02520310|Secondary|Changes in Six Minute Walk Test (6MWT) Distance From Baseline||At 24 months|||||||
2571013|NCT02520310|Secondary|Six Minute Walk Test (6MWT) Distance|The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.|24 months|||||||
2571014|NCT02520310|Secondary|Changes in Six Minute Walk Test (6MWT) Distance From Baseline to 1 Year||Baseline to 1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||meters||Standard Deviation|Mean
2571015|NCT02520310|Secondary|Six Minute Walk Test (6MWT) Distance|The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||meters||Standard Deviation|Mean
2571016|NCT02520310|Secondary|Six Minute Walk Test (6MWT) Distance|The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||meters||Standard Deviation|Mean
2571017|NCT02520310|Secondary|Six Minute Walk Test (6MWT) Distance|The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.|At baseline (Within 14 days prior to the AVJ-514 procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||meters||Standard Deviation|Mean
2571018|NCT02520310|Secondary|Number of Participants With Additional Mitra Clip Device Intervention||Through 5 years|||||||
2571019|NCT02520310|Secondary|Number of Participants Undergoing Mitral Valve Surgery||Through 5 years|||||||
2571020|NCT02520310|Secondary|Change in SF-36 QoL Scores From Baseline||At 24 months|||||||
2571021|NCT02520310|Secondary|SF-36 QoL Scores|The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|24 months|||||||
2571022|NCT02520310|Secondary|Change in SF-36 QoL Scores From Baseline to 1 Year||From baseline to 1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||units on a scale||Standard Deviation|Mean
2571067|NCT02520310|Secondary|Cardiac Output (CO)|Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min||Standard Deviation|Mean
2571023|NCT02520310|Secondary|SF-36 QoL Scores|The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||units on a scale||Standard Deviation|Mean
2571024|NCT02520310|Secondary|SF-36 QoL Scores|The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||units on a scale||Standard Deviation|Mean
2571025|NCT02520310|Secondary|SF-36 QoL Scores|"The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.~The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively."|30 days|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||units on a scale||Standard Deviation|Mean
2571026|NCT02520310|Secondary|SF-36 QoL Scores|"The Short Form(SF) (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.~The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for congestive heart failure (CHF) population are 31 & 46, respectively."|At baseline (Within 14 days prior to the AVJ-514 procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||units on a scale||Standard Deviation|Mean
2571027|NCT02520310|Secondary|KCCQ QoL Scores|The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.|5 years|||||||
2571028|NCT02520310|Secondary|KCCQ QoL Scores|The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.|4 years|||||||
2571029|NCT02520310|Secondary|KCCQ QoL Scores|The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.|3 years|||||||
2571030|NCT02520310|Secondary|KCCQ QoL Scores|The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.|24 months|||||||
2571031|NCT02520310|Secondary|Change in KCCQ QoL Scores From Baseline to 1 Year|KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.|Baseline to 1 Year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||units on a scale||Standard Deviation|Mean
2571032|NCT02520310|Secondary|KCCQ QoL Scores|KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||units on a scale||Standard Deviation|Mean
2571033|NCT02520310|Secondary|KCCQ QoL Scores|KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||units on a scale||Standard Deviation|Mean
2571068|NCT02520310|Secondary|Cardiac Output (CO)|Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min||Standard Deviation|Mean
2571034|NCT02520310|Secondary|KCCQ QoL Scores|KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.|30 days|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||units on a scale||Standard Deviation|Mean
2571035|NCT02520310|Secondary|Kansas City Cardiomyopathy Questionnaire Quality of Life (KCCQ QoL) Scores|KCCQ is a self-administered questionnaire that quantifies physical limitations, symptoms, self-efficacy, social interference and quality of life. This questionnaire is a reliable and responsive health status measure used in various cardiovascular research studies. A minimum mean group difference in KCCQ score of ≥5 is considered to be clinically significant. Each question responses are coded sequentially (1, 2, 3, 4, 5 and 6) from worst to best status. Scores are generated by adding points for all questions and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.|At baseline (Within 14 days prior to the AVJ-514 procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||units on a scale||Standard Deviation|Mean
2571036|NCT02520310|Secondary|NYHA Functional Class|Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.|5 years|||||||
2571037|NCT02520310|Secondary|NYHA Functional Class|Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.|4 years|||||||
2571038|NCT02520310|Secondary|NYHA Functional Class|Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.|3 years|||||||
2571039|NCT02520310|Secondary|NYHA Functional Class|Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.|24 months|||||||
2571040|NCT02520310|Secondary|Number of Participants With NYHA Functional Class|Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2571041|NCT02520310|Secondary|Number of Participants With NYHA Functional Class|Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2571069|NCT02520310|Secondary|Cardiac Output (CO)|Cardiac output as measured by the Echocardiographic Core Laboratory (ECL). Cardiac output is the product of forward stroke volume and heart rate.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min||Standard Deviation|Mean
2571074|NCT02520310|Secondary|Forward Stroke Volume (FSV)||3 years|||||||
2571042|NCT02520310|Secondary|Number of Participants With NYHA Functional Class|Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.|30 days|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571043|NCT02520310|Secondary|Number of Patients With New York Heart Association (NYHA) Functional Class|Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.|At baseline (Within 14 days prior to the AVJ-514 procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571044|NCT02520310|Secondary|Freedom From the Components of the Primary Safety Composite of MAE|MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.|5 years|||||||
2571045|NCT02520310|Secondary|Freedom From the Components of the Primary Safety Composite of MAE|MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.|4 years|||||||
2571046|NCT02520310|Secondary|Freedom From the Components of the Primary Safety Composite of MAE|MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.|3 years|||||||
2571047|NCT02520310|Secondary|Freedom From the Components of the Primary Safety Composite of MAE|MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access.|24 months|||||||
2571048|NCT02520310|Secondary|Number of Participants With the Primary Safety Composite of MAE at 1 Year|MAE is a composite of death, stroke, MI, renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access. No of Participants with the MAEs at 12 months. One death and One Renal Failure was reported in two subjects.|12 months|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571049|NCT02520310|Secondary|All-cause Mortality||5 years|||||||
2571050|NCT02520310|Secondary|All-cause Mortality||4 years|||||||
2571051|NCT02520310|Secondary|All-cause Mortality||3 years|||||||
2571052|NCT02520310|Secondary|All-cause Mortality||24 months|||||||
2571053|NCT02520310|Secondary|Number of Participants With All-cause Mortality||1 year|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571054|NCT02520310|Secondary|Cardiac Index (CI)||5 years|||||||
2571055|NCT02520310|Secondary|Cardiac Index (CI)||4 years|||||||
2571056|NCT02520310|Secondary|Cardiac Index (CI)||3 years|||||||
2571057|NCT02520310|Secondary|Cardiac Index (CI)||24 months|||||||
2571058|NCT02520310|Secondary|Cardiac Index (CI)|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min/m^2||Standard Deviation|Mean
2571059|NCT02520310|Secondary|Cardiac Index (CI)|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min/m^2||Standard Deviation|Mean
2571060|NCT02520310|Secondary|Cardiac Index (CI)|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min/m^2||Standard Deviation|Mean
2571061|NCT02520310|Secondary|Cardiac Index (CI)|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||L/min/m^2||Standard Deviation|Mean
2571062|NCT02520310|Secondary|Cardiac Index (CI)|Cardiac index is defined as cardiac output divided by body surface area. Cardiac Index was measured by the Echocardiographic Core Laboratory (ECL).|At baseline (Within 14 days prior to the AVJ-514 procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||L/min/m^2||Standard Deviation|Mean
2571063|NCT02520310|Secondary|Cardiac Output (CO)||5 years|||||||
2571064|NCT02520310|Secondary|Cardiac Output (CO)||4 years|||||||
2571065|NCT02520310|Secondary|Cardiac Output (CO)||3 years|||||||
2571066|NCT02520310|Secondary|Cardiac Output (CO)||24 months|||||||
2571075|NCT02520310|Secondary|Forward Stroke Volume (FSV)||24 months|||||||
2571086|NCT02520310|Secondary|Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)|Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2571087|NCT02520310|Secondary|Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)|Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL|30 days|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571088|NCT02520310|Secondary|Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)|Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571089|NCT02520310|Secondary|Number of Participants With Systolic Anterior Motion of the Mitral Valve (Present or Absent)|Systolic Anterior Motion (SAM) of the mitral valve is measured by the ECL.|At baseline (Within 14 days prior to the AVJ-514 procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571090|NCT02520310|Secondary|Mean Mitral Valve Pressure Gradient (MVG)||5 years|||||||
2571091|NCT02520310|Secondary|Mean Mitral Valve Pressure Gradient (MVG)||4 years|||||||
2571092|NCT02520310|Secondary|Mean Mitral Valve Pressure Gradient (MVG)||3 years|||||||
2571093|NCT02520310|Secondary|Mean Mitral Valve Pressure Gradient (MVG)||24 months|||||||
2571094|NCT02520310|Secondary|Mean Mitral Valve Pressure Gradient (MVG)|Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
2571095|NCT02520310|Secondary|Mean Mitral Valve Pressure Gradient (MVG)|Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
2571096|NCT02520310|Secondary|Mean Mitral Valve Pressure Gradient (MVG)|Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
2571097|NCT02520310|Secondary|Mean Mitral Valve Pressure Gradient (MVG)|Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
2571098|NCT02520310|Secondary|Mean Mitral Valve Pressure Gradient (MVG)|Defined as the mean and peak pressure gradients across the mitral valve as measured by the Echocardiography Core Laboratory (ECL).|At baseline (Within 14 days prior to the AVJ-514 procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
2571099|NCT02520310|Secondary|Mitral Valve Area (MVA)||5 years|||||||
2571100|NCT02520310|Secondary|Mitral Valve Area (MVA)||4 years|||||||
2571101|NCT02520310|Secondary|Mitral Valve Area (MVA)||3 years|||||||
2571102|NCT02520310|Secondary|Mitral Valve Area (MVA)||24 months|||||||
2571103|NCT02520310|Secondary|Mitral Valve Area(MVA)|It is the orifice area of the mitral valve.|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2571104|NCT02520310|Secondary|Mitral Valve Area(MVA)|It is the orifice area of the mitral valve.|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2571105|NCT02520310|Secondary|Mitral Valve Area (MVA)|It is the orifice area of the mitral valve.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2571106|NCT02520310|Secondary|Mitral Valve Area (MVA)|It is the orifice area of the mitral valve.|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2571107|NCT02520310|Secondary|Mitral Valve Area (MVA)|It is the orifice area of the mitral valve.|At baseline (Within 14 days prior to the AVJ-514 procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||cm^2||Standard Deviation|Mean
2571108|NCT02520310|Secondary|Pulmonary Artery Systolic Pressure (PASP)|Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.|5 years|||||||
2571109|NCT02520310|Secondary|Pulmonary Artery Systolic Pressure (PASP)|Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.|4 years|||||||
2571110|NCT02520310|Secondary|Pulmonary Artery Systolic Pressure (PASP)|Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.|3 years|||||||
2571111|NCT02520310|Secondary|Pulmonary Artery Systolic Pressure (PASP)|Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.|24 months|||||||
2571112|NCT02520310|Secondary|Pulmonary Artery Systolic Pressure (PASP)|Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
2571785|NCT02513719|Secondary|Number of Participants With Target Lesion Failure|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 5 years|ITT population.|||Participants|||Count of Participants
2571113|NCT02520310|Secondary|Pulmonary Artery Systolic Pressure (PASP)|Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
2571114|NCT02520310|Secondary|Pulmonary Artery Systolic Pressure (PASP)|Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
2571115|NCT02520310|Secondary|Pulmonary Artery Systolic Pressure (PASP)|Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
2571116|NCT02520310|Secondary|Pulmonary Artery Systolic Pressure (PASP)|Pulmonary Artery Systolic Pressure (PASP) is presented in place of Right Ventricular Systolic Pressure (RVSP). PASP is equal to RVSP in the absence of pulmonic stenosis.|At baseline (Within 14 days prior to the AVJ-514 procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
2571117|NCT02520310|Secondary|Left Ventricular Ejection Fraction (LVEF)||5 years|||||||
2571118|NCT02520310|Secondary|Left Ventricular Ejection Fraction (LVEF)||4 years|||||||
2571119|NCT02520310|Secondary|Left Ventricular Ejection Fraction (LVEF)||3 years|||||||
2571120|NCT02520310|Secondary|Left Ventricular Ejection Fraction (LVEF)||24 months|||||||
2571121|NCT02520310|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
2571122|NCT02520310|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
2571123|NCT02520310|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.|30 days|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||percentage of ejection fraction||Standard Deviation|Mean
2571124|NCT02520310|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||percentage of ejection fraction||Standard Deviation|Mean
2571125|NCT02520310|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left Ventricular Ejection Fraction (LVEF) as measured by the ECL.|At baseline (Within 14 days prior to the AVJ-514 procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||percentage of ejection fraction||Standard Deviation|Mean
2571126|NCT02520310|Secondary|Left Ventricular End Systolic Dimension (LVESD)||5 years|||||||
2571127|NCT02520310|Secondary|Left Ventricular End Systolic Dimension (LVESD)||4 years|||||||
2571128|NCT02520310|Secondary|Left Ventricular End Systolic Dimension (LVESD)||3 years|||||||
2571129|NCT02520310|Secondary|Left Ventricular End Systolic Dimension (LVESD)||24 months|||||||
2571130|NCT02520310|Secondary|Left Ventricular End Systolic Dimension (LVESD)|Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2571131|NCT02520310|Secondary|Left Ventricular End Systolic Dimension (LVESD)|Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2571132|NCT02520310|Secondary|Left Ventricular End Systolic Dimension (LVESD)|Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.|30 days|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||cm||Standard Deviation|Mean
2571133|NCT02520310|Secondary|Left Ventricular End Systolic Dimension (LVESD)|Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||cm||Standard Deviation|Mean
2571134|NCT02520310|Secondary|Left Ventricular End Systolic Dimension (LVESD)|Left Ventricular End Systolic Dimension (LVESD) as measured by the ECL.|At baseline (Within 14 days prior to the AVJ-514 procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||cm||Standard Deviation|Mean
2571135|NCT02520310|Secondary|Left Ventricular End Diastolic Dimension (LVEDD)||5 years|||||||
2571136|NCT02520310|Secondary|Left Ventricular End Diastolic Dimension (LVEDD)||4 years|||||||
2571137|NCT02520310|Secondary|Left Ventricular End Diastolic Dimension (LVEDD)||3 years|||||||
2571138|NCT02520310|Secondary|Left Ventricular End Diastolic Dimension (LVEDD)||24 months|||||||
2571139|NCT02520310|Secondary|Left Ventricular End Diastolic Dimension (LVEDD)|Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2571140|NCT02520310|Secondary|Left Ventricular End Diastolic Dimension (LVEDD)|Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2572952|NCT02500537|Secondary|Staple Line Assessment: Incidence of Leakage; Post-Op|The incidence of leakage for abdominal procedures; Post-up|Participants will be followed for the duration of hospital stay, on average up to 5 days|Abdominal patients only|||participants|||Number
2571141|NCT02520310|Secondary|Left Ventricular End Diastolic Dimension (LVEDD)|Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).|30 days|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||cm||Standard Deviation|Mean
2571142|NCT02520310|Secondary|Left Ventricular End Diastolic Dimension (LVEDD)|Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||cm||Standard Deviation|Mean
2571143|NCT02520310|Secondary|Left Ventricular End Diastolic Dimension (LVEDD)|Left Ventricular End Diastolic Dimension (LVEDD) as measured by the Echocardiography Core Laboratory (ECL).|At baseline (Within 14 days prior to the AVJ-514 procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||cm||Standard Deviation|Mean
2571144|NCT02520310|Secondary|Left Ventricular End Systolic Volume (LVESV)||5 years|||||||
2571145|NCT02520310|Secondary|Left Ventricular End Systolic Volume (LVESV)||4 years|||||||
2571146|NCT02520310|Secondary|Left Ventricular End Systolic Volume (LVESV)||3 years|||||||
2571147|NCT02520310|Secondary|Left Ventricular End Systolic Volume (LVESV)||24 months|||||||
2571148|NCT02520310|Secondary|Left Ventricular End Systolic Volume (LVESV)|Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
2571149|NCT02520310|Secondary|Left Ventricular End Systolic Volume (LVESV)|Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
2571150|NCT02520310|Secondary|Left Ventricular End Systolic Volume (LVESV)|Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|30 days|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||mL||Standard Deviation|Mean
2571151|NCT02520310|Secondary|Left Ventricular End Systolic Volume (LVESV)|Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||ml||Standard Deviation|Mean
2571152|NCT02520310|Secondary|Left Ventricular End Systolic Volume (LVESV)|Left Ventricular End Systolic Volume (LVESV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.|At baseline (Within 14 days prior to the AVJ-514 procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||mL||Standard Deviation|Mean
2571153|NCT02520310|Secondary|Left Ventricular End Diastolic Volume (LVEDV)||5 years|||||||
2571154|NCT02520310|Secondary|Left Ventricular End Diastolic Volume (LVEDV)||4 years|||||||
2571155|NCT02520310|Secondary|Left Ventricular End Diastolic Volume (LVEDV)||3 years|||||||
2571156|NCT02520310|Secondary|Left Ventricular End Diastolic Volume (LVEDV)|Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular enddiastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|24 months|||||||
2571157|NCT02520310|Secondary|Left Ventricular End Diastolic Volume (LVEDV)|Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
2571158|NCT02520310|Secondary|Left Ventricular End Diastolic Volume (LVEDV)|Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular enddiastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
2571159|NCT02520310|Secondary|Left Ventricular End Diastolic Volume (LVEDV)|Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|30 days|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||mL||Standard Deviation|Mean
2571786|NCT02513719|Secondary|Number of Participants With Target Lesion Failure|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 4 years|ITT population.|||Participants|||Count of Participants
2571160|NCT02520310|Secondary|Left Ventricular End Diastolic Volume (LVEDV)|Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||mL||Standard Deviation|Mean
2571161|NCT02520310|Secondary|Left Ventricular End Diastolic Volume (LVEDV)|Left Ventricular End Diastolic Volume (LVEDV) as measured by the Echocardiography Core Laboratory (ECL). Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.|At baseline (Within 14 days prior to the AVJ-514 procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||mL||Standard Deviation|Mean
2571162|NCT02520310|Secondary|Regurgitant Fraction (RF)|Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of regurgitant fraction||Standard Deviation|Mean
2571163|NCT02520310|Secondary|Regurgitant Fraction (RF)|Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of regurgitant fraction||Standard Deviation|Mean
2571164|NCT02520310|Secondary|Regurgitant Fraction (RF)|Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of regurgitant fraction||Standard Deviation|Mean
2571165|NCT02520310|Secondary|Regurgitant Fraction (RF)|Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of regurgitant fraction||Standard Deviation|Mean
2571166|NCT02520310|Secondary|Regurgitant Fraction (RF)|Regurgitant fraction as determined by the Echocardiographic Core Laboratory (ECL). Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.|At baseline (Within 14 days prior to the AVJ-514 procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of regurgitant fraction||Standard Deviation|Mean
2571167|NCT02520310|Secondary|Regurgitant Volume (RV)||5 years|||||||
2571168|NCT02520310|Secondary|Regurgitant Volume (RV)||4 years|||||||
2571169|NCT02520310|Secondary|Regurgitant Volume (RV)||3 years|||||||
2571170|NCT02520310|Secondary|Regurgitant Volume (RV)||24 months|||||||
2571171|NCT02520310|Secondary|Regurgitant Volume (RV)|Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL/beat||Standard Deviation|Mean
2571172|NCT02520310|Secondary|Regurgitant Volume (RV)|Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL/beat||Standard Deviation|Mean
2571173|NCT02520310|Secondary|Regurgitant Volume (RV)|Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL/beat||Standard Deviation|Mean
2571174|NCT02520310|Secondary|Regurgitant Volume (RV)|Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL/beat||Standard Deviation|Mean
2571175|NCT02520310|Secondary|Regurgitant Volume (RV)|Regurgitant volume as determined by the Echocardiographic Core Laboratory (ECL). In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.|At baseline (Within 14 days prior to the AVJ-514 procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL/beat||Standard Deviation|Mean
2571176|NCT02520310|Secondary|MR Severity Grade||5 years|||||||
2571177|NCT02520310|Secondary|MR Severity Grade||4 years|||||||
2571178|NCT02520310|Secondary|MR Severity Grade||3 years|||||||
2571179|NCT02520310|Secondary|MR Severity Grade||24 months|||||||
2571192|NCT02520310|Secondary|Total Procedure Time|Defined as the time elapsed from the first of any of the following: intravascular catheter placement, anesthesia or sedation, or transesophageal echocardiogram (TEE), to the removal of the last catheter and TEE.|On the day of procedure|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Minutes||Standard Deviation|Mean
2571180|NCT02520310|Secondary|Number of Participants With MR Severity Grade|Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).|1 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2571181|NCT02520310|Secondary|Number of Participants With MR Severity Grade|Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).|6 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2571182|NCT02520310|Secondary|Number of Participants With MR Severity Grade|Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).|30 days|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571183|NCT02520310|Secondary|Number of Participants With MR Severity Grade|Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571184|NCT02520310|Secondary|Number of Participants With Mitral Regurgitation (MR) Severity Grade|Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).|At baseline (Within 14 days prior to the AVJ-514 procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571185|NCT02520310|Secondary|Length of Stay (Not at Baseline Facility)|If subject discharged to another facility (different from baseline facility), length of stay at facility to which subject was discharged. Length of Stay (not at baseline facility) = Sum for all eligible log lines which had been entered in Electronic Data Capture (EDC) for ICU/CCU/PACU and rehabilitation.|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Days||Standard Deviation|Mean
2571186|NCT02520310|Secondary|Percentage of Participants With Discharge Status|Location to which subject was discharged (home or another facility).|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||percentage of participants|||Number
2571187|NCT02520310|Secondary|Length of Rehabilitation Stay|Cumulative days of rehabilitation stay during hospitalization.|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Days||Standard Deviation|Mean
2571188|NCT02520310|Secondary|Length of Hospital Stay Excluding Rehabilitation Stay|Length of hospital stay excluding rehabilitation stay = Length of hospital stay (Date of Discharge - Date of Admission)|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Days||Standard Deviation|Mean
2571189|NCT02520310|Secondary|Length of Stay in Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-Anesthesia Care Unit (PACU) (ICU/CCU/PACU)|Length of stay in ICU/CCU/PACU is cumulative hours of Hospital stay in (PACU/CCU/ICU)|At Discharge (≤ 14.4 ± 8.5 days post index procedure)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Hours||Standard Deviation|Mean
2571190|NCT02520310|Secondary|Fluoroscopy Duration|Defined as the duration of exposure to fluoroscopy during the AVJ-514 procedure.|On the day of procedure|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Minutes||Standard Deviation|Mean
2571191|NCT02520310|Secondary|Device Time|Defined as the time the Steerable Guide Catheter is placed in the intra-atrial septum until the time the AVJ-514 Delivery System (CDS) is retracted into the Steerable Guide Catheter.|On the day of procedure|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Minutes||Standard Deviation|Mean
2571193|NCT02520310|Secondary|Device Procedure Time|Defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed.|On the day of procedure|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Minutes||Standard Deviation|Mean
2571194|NCT02520310|Secondary|Percentage of Participants With Device Implant Rate|Defined as the rate of successful delivery and deployment of one or more AVJ-514 device with echocardiographic evidence of leaflet approximation and retrieval of the delivery catheter.|On the day of procedure|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||percentage of participants|||Number
2571195|NCT02520310|Secondary|Number of Participants With Iatrogenic Atrial Septal Defect|Defined as defect ('hole') in the septum between the left and right atria; considered clinically significant if it requires percutaneous or surgical intervention.|30 days|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571196|NCT02520310|Secondary|Number of Participants With Single Leaflet Device Attachment (SLDA) Not Requiring Surgery|SLDA is defined as attachment of one mitral valve leaflet to the AVJ-514 device.|1 year|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571197|NCT02520310|Secondary|Number of Participants With Single Leaflet Device Attachment (SLDA) Requiring Surgery|SLDA is defined as attachment of one mitral valve leaflet to the AVJ-514 device.|1 year|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571198|NCT02520310|Secondary|Number of Participants With Mitral Valve Stenosis Not Requiring Surgery|Defined as a mitral valve orifice of less than 1.5 cm^2 as measured by the Echocardiography Core Laboratory.|1 year|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571199|NCT02520310|Secondary|Number of Participants With Mitral Valve Stenosis Requiring Surgery|Defined as a mitral valve orifice of less than 1.5 cm^2 as measured by the Echocardiography Core Laboratory.|1 year|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571200|NCT02520310|Secondary|Number of Participants With MAE Occurring After the Femoral Vein Puncture for Transseptal Access|"MAE listed below will be adjudicated by the Clinical Events Committee at 30 days:~Death~Stroke~Myocardial infarction~Renal failure~Non-elective cardiovascular surgery for device or procedure related adverse events"|30 days|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||Participants|||Count of Participants
2571201|NCT02520310|Secondary|Percentage of Participants With MAE at 1 Year|MAE is a composite of death, stroke, myocardial infarction (MI), renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access. This outcome measure calculates the percentage of participants with MAE at 30 days (= total subjects with MAE/total subjects enrolled).|1 year|ITT population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted. This section talks about MAE at 1 year. A total of two MAES were reported through 1 year. 1 MAE for Death and 1 MAE for Renal Failure.|||percentage of participants|||Number
2571202|NCT02520310|Secondary|Percentage of Participants With Major Adverse Events (MAE) at 30 Days|MAE is a composite of death, stroke, myocardial infarction (MI), renal failure, and non-elective cardiovascular surgery for device or procedure related adverse events occurring after the femoral vein puncture for transseptal access. This outcome measure calculates the percentage of participants with MAE at 30 days (= total subjects with MAE/total subjects enrolled).|30 days|Intention-to-Treat (ITT) population is defined as all the subjects who have registered in the study and have AVJ-514 clip device placement attempted.|||percentage of participants|||Number
2571203|NCT02520310|Primary|Number of Participants With Acute Procedure Success (APS)|APS is defined as successful implantation of the AVJ-514 device(s) with resulting MR severity of 2+ or less as determined by the Echocardiographic Core Laboratory (ECL) assessment of a discharge echocardiogram. Subjects who die or who undergo mitral valve surgery before discharge are an APS failure.|On day 0 (the day of procedure)|ITT population.|||Participants|||Count of Participants
2571204|NCT02520284|Secondary|For Cohort 1, Percentage of Participants With MCS Remission (Alternative Definition) at Week 8|The MCS remission (alternative definition) was defined as a rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and PGA subscore (range: 0 to 3 with higher score indicating the severe disease) of 0, and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]) of 0 or 1 for an overall MCS of ≤ 1. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating disease worsening.|Week 8|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2571205|NCT02520284|Secondary|For Cohort 1, Percentage of Participants With Mucosal Healing as Determined by the Geboes Histologic Scoring System at Week 8|Mucosal healing was defined as elimination of ulcers/erosion, elimination of crypt destruction, elimination of intraepithelial neutrophils, elimination of lamina propria neutrophils, and reduction in lamina propria chronic inflammatory cells to at most a mild increase. When measured by the Geboes histologic scoring system, it was the selection of the following combined scores of ≤ 3 for Grade 0 (Structural Architectural Change), ≤ 1 for Grade 1 (Chronic Inflammatory Infiltrate), ≤ 3 for Grade 2A (Lamina Propria Eosinophils), and 0 for Grade 2B (Lamina Propria Neutrophils), Grade 3 (Neutrophils in Epithelium), Grade 4 (Crypt Destruction), and Grade 5 (Erosion or Ulceration). Total Geboes histologic score ranged from 0 to 22, with higher scores indicating greater disease severity.|Week 8|Participants in the Full Analysis Set who did not meet the mucosal healing definition at baseline were analyzed.|||percentage of participants||95% Confidence Interval|Number
2571554|NCT02514551|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|Participants who had anti-ramucirumab antibodies at postbaseline.|Cycle 1 Predose through Follow-up (Up To 24 Months)|All randomized participants who received at least one dose of study drug and were evaluable for ramucirumab anti-drug antibody.|||Participants|||Count of Participants
2571206|NCT02520284|Secondary|For Cohort 1, Percentage of Participants With Endoscopic Response at Week 8|Endoscopic response was defined as endoscopic subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).|Week 8|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2571207|NCT02520284|Secondary|For Cohort 1, Percentage of Participants With Endoscopic Remission at Week 8|Endoscopic remission was defined as endoscopic subscore of 0. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).|Week 8|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2571208|NCT02520284|Secondary|For Cohort 1, Percentage of Participants With MCS Response at Week 8|The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and PGA. The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating disease worsening. The MCS response was defined as a MCS reduction of ≥ 3 points and at least 30% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of 0 or 1.|Week 8|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2571209|NCT02520284|Secondary|For Cohort 1, Percentage of Participants With MCS Remission at Week 8|The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and physician's global assessment (PGA). The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. The MCS remission was defined as a MCS of ≤ 2 points and no individual subscore > 1 point. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating disease worsening.|Week 8|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2571210|NCT02520284|Primary|For Cohort 1, Percentage of Participants With EBS Clinical Remission at Week 8|EBS clinical remission was defined as an endoscopic subscore of 0 or 1 (endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]); rectal bleeding subscore of 0 (rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes); and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1 (stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal).|Week 8|Full Analysis Set included all randomized participants who received at least 1 dose of study drug in the Blinded Induction Phase (Cohort 1).|||percentage of participants||95% Confidence Interval|Number
2571211|NCT02520089|Secondary|Quick Disability of Arm, Shoulder and Hand|It is designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb. Where the better evaluation is equal to 0, and the worst evaluation is equal to 100.|9th months||||units on a scale||Standard Deviation|Mean
2571212|NCT02520089|Primary|Stans Scale|"The evaluation of the radiographic extent of the bony callus (consolidation grade) will be assessed via anteroposterior and lateral radiograph of the arm and classified in different levels, as follows:~Grade 0, no identifiable bony callus .~Grade 1, primary bony callus formation with little or no new periosteal bone.~Grade 2, new periosteal bone formation on two sides of the humerus.~Grade 3, new periosteal bone formation on three or four sides of the humerus."|9th month||||units on a scale||Standard Deviation|Mean
2571213|NCT02519855|Primary|Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody|Antibodies to B-Victoria-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.|Baseline and 4 weeks after Influenza vaccination (Week 4)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.|||Titer||95% Confidence Interval|Geometric Mean
2571214|NCT02519855|Primary|Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody|Antibodies to B-Yamagata-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.|Baseline and 4 weeks after Influenza vaccination (Week 4)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.|||Titer||95% Confidence Interval|Geometric Mean
2571215|NCT02519855|Primary|Geometric Mean Titers of H3N2-specific Influenza Virus Antibody|Antibodies to H3N2-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.|Baseline and 4 weeks after Influenza vaccination (Week 4)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.|||Titer||95% Confidence Interval|Geometric Mean
2571369|NCT02517866|Secondary|Percentage of Participants With DBP <90 mmHg at Week 12|Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.|Week 12|FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.|||percentage of participants||99% Confidence Interval|Number
2571216|NCT02519855|Primary|Geometric Mean Titers of H1N1-specific Influenza Virus Antibody|Antibodies to H1N1-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin.|Baseline and 4 weeks after Influenza vaccination (Week 4)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.|||Titer||95% Confidence Interval|Geometric Mean
2571217|NCT02519855|Primary|Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers|Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.|Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.|||Ratio of titers (Week 4 / Baseline)||95% Confidence Interval|Geometric Mean
2571218|NCT02519855|Primary|Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody|Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group.|Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group)|Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2571219|NCT02519842|Secondary|Percentage of Participants Who Experienced No Vomiting, Regardless of Rescue Medication Use, During the Overall Phase (0 to 120 Hours Post Initiation of Chemotherapy) in Cycle 1|Vomiting was assessed, regardless of rescue medicine use, following the initiation of emetogenic chemotherapy in Cycle 1. A vomiting episode was specified as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching/dry heaves (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes were separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. Rescue medication was permitted to alleviate symptoms of established nausea or vomiting; but not as preventive medication. The percentage of participants with no vomiting and no retching episodes in the overall phase, defined as the time period of 0 to 120 hours post initiation of chemotherapy in Cycle 1, was calculated.|0 to 120 hours post initiation of chemotherapy (up to 15 days after the dose of study drug)|All participants who received at least 1 dose of study drug during Cycle 1.|||Percentage of Participants|||Number
2571220|NCT02519842|Secondary|Percentage of Participants Who Experienced a Complete Response During the Overall Phase (0 to 120 Hours Post Initiation of Chemotherapy) in Cycle 1|Complete Response was defined as no vomiting, no retching, and no use of rescue medication following the initiation of emetogenic chemotherapy in Cycle 1. A vomiting episode was specified as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching/dry heaves (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes were separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of participants with no vomiting and no retching episodes in the overall phase, defined as the time period of 0 to 120 hours post initiation of chemotherapy in Cycle 1, was calculated.|0 to 120 hours post initiation of chemotherapy (up to 15 days after the dose of study drug)|All participants who received at least 1 dose of study drug during Cycle 1.|||Percentage of Participants|||Number
2571221|NCT02519842|Secondary|Percentage of Participants Who Experienced a Complete Response During the Acute Phase (0 to 24 Hours Post Initiation of Chemotherapy) in Cycle 1|Complete Response was defined as no vomiting, no retching, and no use of rescue medication following the initiation of emetogenic chemotherapy in Cycle 1. A vomiting episode was specified as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching/dry heaves (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes were separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of participants with no vomiting and no retching episodes in the acute phase, defined as the time period of 0 to 24 hours post initiation of chemotherapy in Cycle 1, was calculated.|0 to 24 hours post initiation of chemotherapy (up to 1 day after the dose of study drug)|All participants who received at least 1 dose of study drug during Cycle 1.|||Percentage of Participants|||Number
2571222|NCT02519842|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. A statistical analysis was performed to compare the percentage of participants who discontinued in Cycle 1 due to an AE and received fosaprepitant regimen compared with the percentage of participants who received control regimen.|Up to 6 months (up to last dose of study drug)|All participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2571223|NCT02519842|Primary|Percentage of Participants Who Experienced One or More Adverse Events|An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. A statistical analysis was performed for Tier 2 AEs in Cycle 1 to compare the percentage of participants who received fosaprepitant regimen and experienced at least 1 Tier 2 AE compared with the percentage of participants in the control regimen. The Tier 2 endpoint included broad clinical and laboratory AE categories consisting of the percentage of participants with any AE, drug-related AE, serious AE, and AEs that are both drug-related and serious. Tier 2 AEs were not pre-specified as events of interest and inclusion in the Tier 2 analysis required that at least 4 participants in any treatment group exhibited the AE.|Up to 6.5 months (up to 2 weeks after last dose of study drug)|All participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2571224|NCT02519842|Primary|Percentage of Participants Who Experienced a Complete Response During the Delayed Phase (>24 to 120 Hours Post Initiation of Chemotherapy) in Cycle 1|Complete Response was defined as no vomiting, no retching, and no use of rescue medication following the initiation of emetogenic chemotherapy in Cycle 1. A vomiting episode was specified as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching/dry heaves (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes were separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of participants with no vomiting and no retching episodes in the delayed phase, defined as the time period of >24 to120 hours post initiation of chemotherapy in Cycle 1, was calculated.|>24 to 120 hours post initiation of chemotherapy (1 to 15 days after the dose of study drug)|All participants who received at least 1 dose of study drug during Cycle 1.|||Percentage of Participants|||Number
2571225|NCT02519712|Primary|Complete Remission (CR)|"Peripheral Blood Counts: The peripheral blood neutrophil count should be ≥1,500/μl (sustained without growth factor support), and the platelets count should be ≥100,000/μl (without transfusion). No circulating blasts (in the absence of growth factor) should be detected.~Bone Marrow Aspirate: The cellularity of the bone marrow should approximate normal. There must be evidence of maturation of all cell lines. The bone marrow aspirate should contain < 5% blasts. Auer rods should not be detected.~Extramedullary Leukemia: Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present."|4 weeks|Data were not collected||||||
2571226|NCT02519595|Secondary|Sedation Satisfaction|Consultants will be asked to rate their level of satisfaction with sedation on a Likert Scale of 1-3|At the end of the procedure. Approximately 1 hour|consultant satisfaction missing in 6 participants|||participants|||Number
2571227|NCT02519595|Secondary|Adverse Events|Adverse events secondary to sedation experienced by the patient and interventions performed to overcome them|Patients will be assessed after administration of medication until discharge and will have a follow up phone call 48 hours after discharge for 3 attempts. 5 days.,||||participants|||Number
2571228|NCT02519595|Secondary|Additional Dose|Number of participants to whom additional doses of ketamine administered apart from the study dose|Patients will be assessed during procedure . Approximately 1 hours||||participants|||Number
2571229|NCT02519595|Secondary|Sedation Duration|Length of sedation was defined as the time duration from the administration of study medication until ready for discharge using standardized discharge criteria (Aldrete scoring >9) followed at our institution.|Patients will be assessed during the length of time from administration of sedation medication until ready for discharge, Approximately 3 hours||||Minutes||Inter-Quartile Range|Median
2571230|NCT02519595|Primary|Pain|"Measure pain using self reported Wong Baker faces pain rating scale prior to sedation, during sedation and prior to discharge.The scale shows a series of faces ranging from a happy face at 0, No hurt to a crying face at 10 Hurts worst. The patient must choose the face that best describes how they are feeling. The score has values of 0(no hurt), 2(hurts little bit), 4(hurts little more), 6(hurts even more), 8(hurts whole lot),10 (hurts worst). The patient chooses one number that describes the pain best (eg. Either a 2 or 4)."|Patients will be assessed during the procedure after administration of sedation medicaiton. Approximately 30 minutes||||units on a scale||Inter-Quartile Range|Median
2571231|NCT02519595|Primary|Sedation Efficacy|Measure sedation depth using Ramsay Sedation Scale. Varies from 1-6 with 1: anxious, agitated, restless 2: Cooperative, oriented, tranquil 3: responsive to commands 4: Brisk response to light glabellar tap or auditory stimulus 5: Sluggish response to light glabellar tap or loud auditory stimulus 6 being no response to light glabellar tap or loud auditory stimulus. Higher the score, greater is the depth of sedation. Use of ketamine usually provides a depth of sedation of 5 or 6.|Participants will be assessed after study drug adminsitration and the maximum depth of sedation achieved recorded. Approximately 2 hours||||units on a scale||Inter-Quartile Range|Median
2571232|NCT02519504|Primary|Structure-Function-Praxis (SFP) Exam Score|"SFP is a non-standardized 53-item exam of the oral and facial structures (Structure), the range and speed of movement of the oral and facial structures (Function), and the ability to imitate non-speech single and sequential movements (Praxis). The Structure score had a range of 0-10, with 10 items scored as 0-within functional limits, or 1-deviant. The Function score had a range of 0-66, consisting of 33 items scored as 0- within functional limits, 1- mild/moderate impairment, or 2- severe impairment. The Praxis score had a scale from 0-40, and consisted of 10 items scored as 0- imitates immediately, 1- mild groping; or delayed but successful, 2- groping or sequential efforts, then success, 3- could not achieve imitation with purposeful effort, or 4- child does not/cannot attempt the task. The scores from the three domains are summed to create an overall SFP score, with a possible range of 0 -116. For this exam, the closer to zero, the better the score."|Baseline||||score on a scale||Full Range|Mean
2571233|NCT02519504|Primary|The Children's Depression Inventory-2 (CDI-2) Score|The Children's Depression Inventory-2 (CDI-2) is a screening measure for symptoms of depression in children. It is a self-report form and includes 12 items. Each item receives a score of 0-2, where 0 = the absence of depressive symptoms and 2 = definite symptoms of depression. Total raw scores are converted to t-scores, with a mean of 50 and a standard deviation of 10. T-scores between 45 and 55 are generally considered normal and higher scores indicates more depressive symptoms.|Baseline|There were 2 occasions where due to unforeseen scheduling issues the study team was not able to do the psych testing on 2 control participants, this applies to all outcome measures with 142 controls instead of 144.|||t-score||Standard Deviation|Mean
2571234|NCT02519504|Primary|The Goldman Fristoe Test of Articulation-3 (GFTA-3) Score|The Goldman Fristoe Test of Articulation-3 (GFTA-3) is a systemic measure of articulate consonant and vowel sounds for children. The average standard score for this test is 100, with a standard deviation of 15 and a range of 50-150, with higher scores indicating better articulation. The raw score of the number of speech errors during the test, and is converted to a standard score based on age and sex.|Baseline||||score on a scale||Standard Deviation|Mean
2571235|NCT02519504|Primary|Hand Strength Value|Hand strength will be assessed with a standard pediatric dynamometer. Pediatric reference ranges for hand strength vary depending on age and gender; for this study the hand strength of cases and controls are compared.|Baseline|One control was not able to be collected due to a broken hand/arm in a cast (could not complete task).|||kilograms||Standard Deviation|Mean
2571384|NCT02517580|Secondary|Change From Baseline in Central Pressure by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks||8 weeks|||||||
2571236|NCT02519504|Primary|Pediatric Adventitious Movement Scale - Archimedes Spiral Task Measurement|"This measure involves using a stylus pen to draw an Archimedes spiral in between the lines of a spiral template that is displayed on the tablet screen. The drawn spiral is recorded by the Neuroglyphics software on a SurfacePro3 tablet which displays the spiral template and records position and pressure of the pen tip as the subject draws. The pen should be held such that no part of the hand or arm touches the table. The scoring for this measure is the root mean square (RMS) of the drawn spiral compared to the ideal spiral. The root mean square is the square root of the arithmetic mean of the squares of a set of numbers representing the distance between processive points on an actual spiral drawn by a participant and what would have been an ideal spiral drawn mid-way between the template outlines provided on the tablet. The closer the drawn spiral was to the ideal spiral the smaller the RMS value will be."|Baseline|The study team had significant technical issues with this program and so it did not work at all for a number of testing blocks, resulting in a much smaller number of participants collected.|||root mean square (in millimeters)||Standard Deviation|Mean
2571237|NCT02519504|Primary|Pediatric Adventitious Movement Scale - Upper Extremity Steadiness Score|"The upper extremity steadiness assessment is the dot task, where subjects are asked to hover a pen/stylus a dot steadily for 20 seconds without touching the page/screen and keeping the arm/elbow lifted off the table. Movement in the X, Y, and Z dimensions (left-right, up-down, vertical movement) are recorded on video and scored by overlaying a measurement onto the video to determine the extent of adventitious movement. A lower score indicates increased upper extremity steadiness, with 0 being no movement.~0 = no adventitious movement,~= adventitious movement is barely visible, 1.5 = adventitious movement is visible, but less than 1 cm,~= adventitious movement is 1- < 3 cm amplitude, 2.5 = adventitious movement is 3- < 5 cm amplitude,~= adventitious movement is 5- < 10 cm amplitude, 3.5 = adventitious movement is 10- < 20 cm amplitude,~= adventitious movement is > 20 cm amplitude."|Baseline|There were 2 children who had prior broken arms/injuries to the left hand that could only do the test on the right hand side.|||score on a scale||Standard Deviation|Mean
2571238|NCT02519504|Primary|Number of Children Participating in Special Education or Other Intervention Experiences|Questionnaire developed by project staff based on experiences of children, as reported by parents, with classic galactosemia with questions on specific problems experienced, when identified, placement or intervention, other problems.|Baseline|These questions were part of a survey administered to parents prior to part 2 testing, 4 of these surveys gave incomplete answers to these questions.|||Participants|||Count of Participants
2571239|NCT02519504|Primary|Revised Children's Manifest Anxiety Scale-2nd Edition (RCMAS-2) T-Scores|RCMAS measures for the presence of academic stress, test anxiety, peer and family conflicts, and drug problems in children. The test consists of 49 yes/no items and a total score is calculated by summing the number of yes responses. The total raw score is converted to a t-scores with a mean of 50 and a standard deviation of 10. Scores above 60 generally indicate that the child is experiencing some level of anxiety.|Baseline|Unable to collect this measure on one child due to scheduling restraints|||t-score||Standard Deviation|Mean
2571240|NCT02519504|Primary|Child Behavior Checklist for Ages 6-18 (CBCL/6-18) T-Scores|The CBCL is a parent-reported measure that evaluates a child internalizing and externalizing behaviors and total problems. It consists of 140 questions on a Likert-scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. Total raw scores are converted to t-scores with a mean of 50 and standard deviation of 10. Higher scores indicative of better behavior and less problems.|Baseline|These were parent surveys and 4 surveys were not completed (forgot back page) and they did not respond to requests later to complete it.|||t-score||Standard Deviation|Mean
2571241|NCT02519504|Primary|Social Skills Improvement System (SSIS) Rating Scales Score|"The SSIS is a parent-reported measure that evaluates Social Skills and Problem Behaviors. 38 items are rated in a Likert-scale of 0 (never) to 3 (very often). The raw scores are converted to scaled scores with a mean of 100, a standard deviation of 15, and a range of 50-150. Standard scores are derived from the scores of a large nationally representative sample of individuals having a similar age and the same sex. Higher standard scores for Social Skills indicate more positive social skills, while higher standard scores for Problem Behaviors indicates more maladaptive behaviors (i.e. lower scores indicate fewer problem behaviors)."|Baseline|This was a parent survey. Four were unable to be scored because they were incomplete (2 cases and 2 controls) and 1 case survey that had the social skills section complete but the problem behaviors section incomplete, so could only be partially scored.|||score on a scale||Standard Deviation|Mean
2571242|NCT02519504|Primary|Essential Tremor Rating Assessment Scale (TETRAS) Score|TETRAS consists of 10 items that evaluate tremor in the head, arms, and legs. The rater assigns a score of 0 to 4 for each item, in ascending order of severity. Total scores range from 0 to 40 with higher scores indicating greater severity of tremors.|Baseline||||score on a scale||Standard Deviation|Mean
2571243|NCT02519504|Primary|Iowa Oral Performance Instrument (IOPI) Tongue Strength Value|IOPI is a hand held manometer which measures intraoral pressure generated by compression of an air filled bulb by the tongue against the palate. Strength is measured in kilopascal (kPa). Typically, tongue strength is decreased in subjects with classic galactosemia and can contribute to speech disorders.|Baseline|There are fewer participants for this outcome measure - these children have dental/orthodontic fixed wires over the roof of their mouth that made it impossible to do this task.|||kilopascal (kPa)||Standard Deviation|Mean
2571244|NCT02519504|Primary|Movement Assessment Battery for Children-2 (Movement ABC-2): Performance Test Percentiles|Movement ABC-2: Performance test is designed to identify and describe impairments in motor performance of children and adolescents 3-16 years of age. The Performance Test involves children completing a series of fine and gross motor tasks grouped into three categories: Manual Dexterity, Aiming and Catching, and Balance. A tester will observe and record how the child performs the task. The scores are given in percentiles, with 50% being the average score- below 50% means below average, and a range of 1%-99%. Children whose performance falls below the 15th percentile may benefit from intervention, with those between the 6th and 15th percentile being at risk for Developmental Coordination Disorder (DCD). Those whose performance is at or below the 5th percentile represent children with DCD if other criteria are also met.|Baseline||||Percentile||Standard Deviation|Mean
2571385|NCT02517580|Primary|Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks||8 weeks||||m/s||Standard Error|Mean
2571585|NCT02514122|Secondary|Hallucination|Presence (or not) of hallucinations.|From end of surgery until 60 hours postoperative.||||Participants|||Count of Participants
2571245|NCT02519504|Primary|Oral and Written Language (2nd Edition (OWLS-II): Oral Expression (OE)) Scales Score|The OWLS-II: LC measures oral language expression, which is the use of spoken language. The examiner orally presents a verbal prompt along with a picture and the participant must respond orally to the prompt with increasingly difficult language. The raw score of the number of correct responses is converted to a standard score based on age. The mean standard score for this test is 100, with a standard deviation of 15 and a range of 50-150, with higher scores indicating better listening comprehension.|Baseline||||score on a scale||Standard Deviation|Mean
2571246|NCT02519504|Primary|Oral and Written Language (2nd Edition (OWLS-II): Listening Comprehension (LC)) Scales Score|The OWLS-II: LC measures oral language reception, which is the understanding of spoken language. The examiner orally presents increasingly difficult words, phrases, and sentences to the participants and he/she responds by pointing to or stating which of the four pictures is correct. The raw score of the number of correct responses is converted to a standard score based on age. The mean standard score for this test is 100, with a standard deviation of 15 and a range of 50-150, with higher scores indicating better listening comprehension.|Baseline||||score on a scale||Standard Deviation|Mean
2571247|NCT02519504|Primary|Acoustic Voice Quality Index (AVQI) Score|The Acoustic Voice Quality Index (AVQI) uses multiple acoustic markers to assess dysphonia. Scores can range from 0 to 10 and scores from 0 to 3 suggest normophonia while 10 represents severe dysphonia.|Baseline|Scores for 5 cases and 3 controls were not collected due to excessive ambient noise in the background of the recording interfering with audio quality.|||score on a scale||Standard Deviation|Mean
2571248|NCT02519504|Primary|Diadochokinetic (DDK) Speech Rate|The Diadochokinetic (DDK) speech rate assesses speech and language problems. The DDK rate measures how quickly a participant can say a series of sounds. Scores are second/syllable. Lower value = faster talker. Lowest value of 2-3 trials, or only 1 trial provided/audible.|Baseline|Missing/incomplete audio recording from 5 participants|||second/syllable||Standard Deviation|Mean
2571249|NCT02519504|Primary|Diagnostic Evaluation of Articulation and Phonology (DEAP) Score|"The DEAP evaluates both articulation and phonological processes. The DEAP includes a Diagnostic Screen, a diagnostic Articulation Assessment, a diagnostic Phonology Assessment (with a phonological analysis), and an Oral Motor Screen. The Diagnostic Screen can determine whether a child has a speech difficulty. If all words were produced at least twice (2 of 3 possible trials), there were 25 targets available (25 points possible). Any difference across the 3 trials for 1 word counted as 1 point. For example, 4 instances of words produced differently is 4/25 = 16% occurrence. The test establishes inconsistent production at greater than or equal to 40%."|Baseline|There were 7 cases and 16 controls with missing scores-23 total. The reasons were: Missing or Incomplete audio files for scoring reference (21), participant not following instructions (1), and excessive static in background, file inaudible (1).|||percentage of Inconsistent word producti||Standard Deviation|Mean
2571250|NCT02519504|Primary|Number of Participants Who Failed Pure-tone Hearing Assessment|"Pure-tone hearing test measures both conductive and sensorineural hearing loss. In this procedure, sounds are presented at different frequencies and volumes through speakers, headphones, and small devices placed behind the ear while the participant stands in a soundproof booth. Pass 1 / Fail 2, scores are presented as % of case/control who failed the hearing screen. Hearing was screened in the right and then left ear at 500, 1000, 2000, and 4000 Hz at 30 DB using pure tones in a non-sound proof room. A child received a 1 if s/he responded to all frequencies in both ears and a 2 if s/he did not respond with 2 attempts at one or more frequencies."|Baseline||||Participants|||Count of Participants
2571251|NCT02519504|Primary|Brain Wave Latency Assessment Value|The ABER measures the initial response of the auditory pathway to sounds by quantifying the cranial nerve 8 conduction and brain wave latency and amplitude. Three electrodes were attached, one on the forehead and one on each earlobe, to assess response to stimulation. Responses to a clicking sound are recorded by a computerized system.There is not a normative expected range - higher scores mean that the signal is being conducted slower and lower values means that it is being conducted faster.|Baseline|Number of subjects were unable to be scored due to data collection issues(6 cases and 6 controls). Of those that were analyzed, not all of wave latencies were interpretable- which is why the numbers are different. Often wave 1 latency data would not be interpretable, and so would not have a score, but waves 3 and 5 were readable and scored.|||ms (milliseconds)||Standard Deviation|Mean
2571252|NCT02519504|Primary|Wechsler Abbreviated Scale of Intelligence-II (WASI-II): Matrix Reasoning Score|The WASI-II: Matrix Reasoning subtest is a quick estimate of an individual's level of intellectual functioning. The subtest is comprised of 35 incomplete grid patterns that require the participant to select the correct response from five possible choices. Scores are scaled to a t-score with a mean of 50 and standard deviation of 10. Scores above 50 indicate greater intellectual ability.|Baseline|There were 2 occasions where due to unforeseen scheduling issues the study team was not able to do the psych testing on 2 control participants, this applies to all outcome measures with 142 controls instead of 144.|||t-score||Standard Deviation|Mean
2571253|NCT02519504|Primary|Wechsler Abbreviated Scale of Intelligence-II (WASI-II): Vocabulary Score|The WASI-II: Vocabulary subtest is a quick estimate of an individual's level of intellectual functioning. The subtest is comprised of 42 total items that require the subject to orally define 4 images and 37 words presented both orally and visually. Scores are scaled to a t-score with a mean of 50 and standard deviation of 10. Scores above 50 indicate greater intellectual ability.|Baseline|There were 2 occasions where due to unforeseen scheduling issues the study team was not able to do the psych testing on 2 control participants, this applies to all outcome measures with 142 controls instead of 144.|||t-score||Standard Deviation|Mean
2571254|NCT02519504|Primary|Behavior Rating Inventory of Executive Function (BRIEF) Score|Behavior Rating Inventory of Executive Function (BRIEF) is a questionnaire composed of three indices: Global Executive Composite, Behavioral Regulation Index, and Metacognition Index. Items are rated in a Likert-scale with 1 (never), 2 (sometimes), and 3 (often). The Global Executive Composite consists of 72 items with scoring ranging from 72 to 216. The Behavioral Regulation Index score is the total of 28 items and ranges from 28 to 84. The Metacognition Index score is the total of 44 items and ranges from 44 to 132. Raw scores are standardized to t-scores with a mean of 50 with a standard deviation of 10. Scores above 50 suggest increased difficulty while scores under 50 reflect better functioning.|Baseline|There were 2 occasions where due to unforeseen scheduling issues the study team was not able to do the psych testing on 2 control participants, this applies to all outcome measures with 142 controls instead of 144.|||t-score||Standard Deviation|Mean
2571255|NCT02519504|Primary|Planning Ability in the Visual-Spatial Domain Using A Developmental NEuroPSYchological Assessment-II (NEPSY-II): Route-Finding Score|The route finding subtest is designed to assess knowledge of visual spatial relations and directionality, as well as the ability to use this knowledge to transfer a route from a simple schematic map to a more complex one. The participant is shown a schematic map with a target house and asked to find that house in a larger map with other houses and streets. Scores could range from 0 to 20 with higher scores indicating better performance with visuospatial relations and orientation.It's broken into percentile categories: <2% =1, 2-10%= 2, 11-25%=3, 26-75%=4, >75%=5. The scores from the percentile categories described are reported. Higher numbers in the percentile categories indicate better performance with visuospatial relations and orientation.|Baseline|There were 2 occasions where due to unforeseen scheduling issues the study team was not able to do the psych testing on 2 control participants, this applies to all outcome measures with 142 controls instead of 144.|||percentile categories||Inter-Quartile Range|Median
2571256|NCT02519504|Primary|Executive Functioning in Verbal Domain Using A Developmental NEuroPSYchological Assessment-II (NEPSY-II) - Number of Words Generated|The word generation subtest is designed to assess verbal productivity through the ability to generate words within specific semantic and initial letter categories. The participant is given a semantic or initial letter category and asked to produce as many words as possible in 60 seconds. Scores represent the number of words generated and higher scores indicate better executive control of language production, better inhibition and ideation, or better vocabulary knowledge.|Baseline|Only participants aged 7 to 12 were administered this assessment; there is not a version of this test for 6 year olds. Therefore number of subjects analyzed is different from number of enrolled|||Number of words||Standard Deviation|Mean
2571257|NCT02519504|Primary|Wechsler Intelligence Scale for Children IV-Integrated (WISC-IV-Integrated): Spatial Span Score|Spatial working memory was assessed using the Wechsler Intelligence Scale for Children IV-Integrated (WISC-IV-Integrated): Spatial Span During the forward task, participants are presented with a board containing blue blocks randomly arranged. The rater first taps out a pattern of blocks, beginning with two blocks and increasing the number of blocks in the pattern with participant proficiency, and the participant is tasked with tapping the same pattern. For the backwards test, the participant is tasked with tapping out the reverse pattern after the rater's demonstration. These patterns also begin with two blocks and increase with participant proficiency. The score is the number of patterns completed correctly. Scores can range from 0 to 16 with higher scores indicating better performance.|Baseline|There were 2 occasions where, due to unforeseen scheduling issues, the study team was not able to do the psych testing on 2 control participants, this applies to all outcome measures with 142 controls instead of 144.|||number of patterns completed correctly||Standard Deviation|Mean
2571258|NCT02519504|Primary|Wechsler Intelligence Scale for Children IV-Integrated (WISC-IV-Integrated): Digit Span Score|Auditory working memory can be assessed using WISC-IV-Integrated: Digit Span test. The digit span test forward assesses attention and short-term memory while the digit span test backward assesses working memory. For the forward test, the examinee listens while examiner says a series of numbers and asks the participant to repeat them back in the same order. For the backward test, the examiner will ask the examinee to repeat the numbers backwards, that is, by starting with the last number said and going backwards to the first number said. This process continues until the examinee can no longer remember either the full sequence of numbers or the correct order. Both forward and reverse trials are given twice. The Digit Span test is scored by the amount of numbers the examinee was able to remember in each test. Scores could range from 0 to 16 with higher scores indicating better performance.|Baseline|This assessment was not administered during the study because it was redundant to other tests already being used.||||||
2571259|NCT02519504|Primary|Children's Memory Scale Score|The Children's Memory Scale assesses memory and learning across three domains: auditory/verbal, visual/nonverbal, and attention/concentration. Each domain contains two core subtests and one supplemental subtest, each of which contain both an immediate and delayed memory portion. From these subtests, eight Index scores are derived: Visual Immediate, Visual Delayed, Verbal Delayed, Verbal Delayed, Delayed Recognition, Overall Learning, Attention/Concentration, and General Memory. The Index scores represent functioning within and across the domains. The scaled scores of the subtests relevant to each Index score are summed, and from this sum, a normed Index score is derived. Each Index score has a range of 50-150, and an average score of 100, with most children scoring between 85 and 115 (SD=15). Lower scores indicate impaired memory abilities.|Baseline|There were 2 occasions where due to unforeseen scheduling issues the study team was not able to do the psych testing on 2 control participants, this applies to all outcome measures with 142 controls instead of 144.|||score on a scale||Standard Deviation|Mean
2571260|NCT02519387|Secondary|Tolerability of Buprenorphine Patch Determined by Number of Patients Who Withdrew From the Study Due to Adverse Events||3 months|This is the intent-to-treat population.|||participants|||Number
2571261|NCT02519387|Secondary|Physicians' and Patients' Treatment Satisfaction of Buprenorphine Patch Usage Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively|"The overall assessment of the change in pain intensity from baseline is measured at Visit 6.~Physician's Global Impression of Change scale: Investigator's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse Patient's Global Impression of Change scale: Subject's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse"|3 months||||units on a scale||Standard Deviation|Mean
2571262|NCT02519387|Secondary|Daily Use of Breakthrough Pain Medication as Measured by Number of Subjects With at Least 1 Day of Breakthrough (Rescue) Pain Medication Usage|Patients will record any other pain medication used in a patient home diary|3 months||||participants|||Number
2571263|NCT02519387|Secondary|Change in Sleep Quality as Determined by the 8-item Global Sleep Quality Assessment (GSQA)|"Subjects will evaluate the degree of their sleep disturbance due to pain and improvement in quality of sleep using the GSQA questionnaire comprising of 8 questions, at baseline (Visit 1) and Visit 6 (3 months from baseline visit).~The scores at baseline and Visit 6 are calculated for the following 8 items with scores of:~Trouble falling asleep due to pain -- on a scale of 0 to 10 where 0 is never and 10 is always~Need for pain medication to sleep -- as above~Need for sleep medication to sleep -- as above~Awakened by pain at night -- as above~Awakened by pain in the morning -- as above~Pain affecting partner's sleep -- as above~Rate own sleep quality -- on a scale of 1 to 5 where 1 is very good and 5 is very poor~Number of hours of sleep per night in last 7 days"|Baseline, 3 months||||units on a scale||Standard Deviation|Mean
2571264|NCT02519387|Primary|Change in Box Scale-11 (BS-11) Pain Score|"The BS-11 (Box score-11) pain score was the main efficacy outcome measured in this study. The scores at baseline (Visit 1) and Visit 6 (3 months from baseline visit) are reported.~BS-11 is an 11-point scale measuring pain intensity. It ranges from 0 to 10, whereby 0 represents no pain and 10 represents the worst imaginable pain. Subjects selected a number based on the pain intensity they were feeling at that time."|Baseline,3 months|These patients were eligible and included in the intent-to-treat efficacy population.|||units on a scale||Standard Deviation|Mean
2571265|NCT02519244|Secondary|Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Mental Health Composite Score|MSQOL-54 mental health composite scores range from 0 to 100, with a higher scale score indicating improved quality of life|3 weeks||||score||Standard Deviation|Mean
2571266|NCT02519244|Secondary|Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Mental Health Composite Score|MSQOL-54 mental health composite scores range from 0 to 100, with a higher scale score indicating improved quality of life|baseline||||score||Standard Deviation|Mean
2571267|NCT02519244|Secondary|Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Physical Health Composite Score|MSQOL-54 physical health composite scores range from 0 to 100, with a higher scale score indicating improved quality of life|3 weeks||||score||Standard Deviation|Mean
2571268|NCT02519244|Secondary|Quality of Life as Assessed by the Multiple Sclerosis Quality of Life-54 (MSQOL-54) Questionnaire - Physical Health Composite Score|MSQOL-54 physical health composite scores range from 0 to 100, with a higher scale score indicating improved quality of life|baseline||||score||Standard Deviation|Mean
2571269|NCT02519244|Secondary|Amount of Time Taken to Complete the Time Up and Go Test (Without Exoskeleton)|This task will be performed with and without exoskeleton. This task involves subject to stand from the standard chair, walk straight for 3 meters, turn around, walk back to the chair and sit down with shoes and assistive devices if any. A standard chair with arm rests will be place at the start of the testing course. A mark will be placed on the floor at the 3 meter distance.|3 weeks|One subject was not able to perform the Timed Up and Go test because they required support to sit and stand.|||seconds||Standard Deviation|Mean
2571270|NCT02519244|Secondary|Amount of Time Taken to Complete the Time Up and Go Test (Without Exoskeleton)|This task will be performed with and without exoskeleton. This task involves subject to stand from the standard chair, walk straight for 3 meters, turn around, walk back to the chair and sit down with shoes and assistive devices if any. A standard chair with arm rests will be place at the start of the testing course. A mark will be placed on the floor at the 3 meter distance.|baseline|One subject was not able to perform the Timed Up and Go test because they required support to sit and stand.|||seconds||Standard Deviation|Mean
2571271|NCT02519244|Secondary|Cognitive Demands as Indicated by Reaction Time in Dual Task Paradigm (With Exoskeleton)|Cognitive demands during the Timed 25 Feet Walk Test at self-selected pace with and without exoskeleton will be determined by reaction time using a dual-task paradigm. We chose a simple reaction time (RT) task, in which the response will be biting on a pressure sensor to make the response pathways as independent as possible from the motor pathways of locomotion. The secondary RT task consists of biting a pressure transducer placed in the mouth in response to an unpredictable sensory (will not cause pain) electrical stimulation applied by an electrode on the back of the neck without changing walking speed and pattern. The stimulation intensity will be adjusted for each individual before data collection. Shorter RT indicates that reduced amount of attentional resources are required.|3 weeks|For three of the subjects not reported, there were technical issues during assessment.|||seconds||Standard Deviation|Mean
2571272|NCT02519244|Secondary|Cognitive Demands as Indicated by Reaction Time in Dual Task Paradigm (Without Exoskeleton)|Cognitive demands during the Timed 25 Feet Walk Test at self-selected pace with and without exoskeleton will be determined by reaction time using a dual-task paradigm. We chose a simple reaction time (RT) task, in which the response will be biting on a pressure sensor to make the response pathways as independent as possible from the motor pathways of locomotion. The secondary RT task consists of biting a pressure transducer placed in the mouth in response to an unpredictable sensory (will not cause pain) electrical stimulation applied by an electrode on the back of the neck without changing walking speed and pattern. The stimulation intensity will be adjusted for each individual before data collection. Shorter RT indicates that reduced amount of attentional resources are required.|3 weeks|For three of the subjects not reported, there were technical issues during assessment.|||seconds||Standard Deviation|Mean
2571273|NCT02519244|Primary|Physical Demands as Assessed by Energy Expenditure (Which is Indicated by VO2-max as Measured by the Cosmed K4b2) During the Six-Minute Walk Test (With Exoskeleton)|"Physical demands during the Six-Minute Walk Test will be indicated by energy expenditure. Energy Expenditure (as indicated by VO2-max) will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.~VO2-max, also known as maximal oxygen uptake, is the measurement of the maximum amount of oxygen a person can utilize during exercise."|3 weeks|For two of the subjects not reported, there were technical issues during assessment.|||ml/min/Kg||Standard Deviation|Mean
2571274|NCT02519244|Primary|Physical Demands as Assessed by Energy Expenditure (Which is Indicated by VO2-max as Measured by the Cosmed K4b2) During the Six-Minute Walk Test (Without Exoskeleton)|"Physical demands during the Six-Minute Walk Test will be indicated by energy expenditure. Energy Expenditure (as indicated by VO2-max) will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.~VO2-max, also known as maximal oxygen uptake, is the measurement of the maximum amount of oxygen a person can utilize during exercise."|3 weeks|One subject did not perform the Timed 25 Feet Walk Test at Fast Speed due to fatigue. For another subject, there was a technical error during the assessment.|||ml/min/Kg||Standard Deviation|Mean
2571275|NCT02519244|Primary|Physical Demands as Assessed by Energy Expenditure (Which is Indicated by VO2-max as Measured by the Cosmed K4b2) During the Six-Minute Walk Test (Without Exoskeleton)|"Physical demands during the Six-Minute Walk Test will be indicated by energy expenditure. Energy Expenditure (as indicated by VO2-max) will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.~VO2-max, also known as maximal oxygen uptake, is the measurement of the maximum amount of oxygen a person can utilize during exercise."|baseline|One subject did not perform the Timed 25 Feet Walk Test at Fast Speed due to fatigue. For another subject, there was a technical error during the assessment.|||ml/min/Kg||Standard Deviation|Mean
2571276|NCT02519244|Primary|Physical Demands as Assessed by Energy Expenditure (Which is Indicated by VO2-max as Measured by the Cosmed K4b2) During the Timed 25 Feet Walk Test at Fast Speed (With Exoskeleton)|"Physical demands during the Timed 25 Feet Walk Test will be indicated by energy expenditure. Energy Expenditure (as indicated by VO2-max) will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.~VO2-max, also known as maximal oxygen uptake, is the measurement of the maximum amount of oxygen a person can utilize during exercise."|3 weeks|For two of the subjects not reported, there were technical issues during assessment.|||ml/min/Kg||Standard Deviation|Mean
2571277|NCT02519244|Primary|Physical Demands as Assessed by Energy Expenditure (Which is Indicated by VO2-max as Measured by the Cosmed K4b2) During the Timed 25 Feet Walk Test at Fast Speed (Without Exoskeleton)|"Physical demands during the Timed 25 Feet Walk Test will be indicated by energy expenditure. Energy Expenditure (as indicated by VO2-max) will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.~VO2-max, also known as maximal oxygen uptake, is the measurement of the maximum amount of oxygen a person can utilize during exercise."|3 weeks|One subject did not perform the Timed 25 Feet Walk Test at Fast Speed due to fatigue. For another subject, there was a technical error during the assessment.|||ml/min/Kg||Standard Deviation|Mean
2571278|NCT02519244|Primary|Physical Demands as Assessed by Energy Expenditure (Which is Indicated by VO2-max as Measured by the Cosmed K4b2) During the Timed 25 Feet Walk Test at Fast Speed (Without Exoskeleton)|"Physical demands during the Timed 25 Feet Walk Test will be indicated by energy expenditure. Energy Expenditure (as indicated by VO2-max) will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.~VO2-max, also known as maximal oxygen uptake, is the measurement of the maximum amount of oxygen a person can utilize during exercise."|baseline|One subject did not perform the Timed 25 Feet Walk Test at Fast Speed due to fatigue. For another subject, data was not collected for the the Timed 25 Feet Walk Test at Fast Speed due to a technical error.|||ml/min/Kg||Standard Deviation|Mean
2571279|NCT02519244|Primary|Physical Demands as Assessed by Energy Expenditure (Which is Indicated by VO2-max as Measured by the Cosmed K4b2) During the Timed 25 Feet Walk Test at Self-selected Speed (With Exoskeleton)|"Physical demands during the Timed 25 Feet Walk Test will be indicated by energy expenditure. Energy Expenditure (as indicated by VO2-max) will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.~VO2-max, also known as maximal oxygen uptake, is the measurement of the maximum amount of oxygen a person can utilize during exercise."|3 weeks|For two of the subjects not reported, there were technical issues during assessment.|||ml/min/Kg||Standard Deviation|Mean
2571280|NCT02519244|Primary|Physical Demands as Assessed by Energy Expenditure (Which is Indicated by VO2-max as Measured by the Cosmed K4b2) During the Timed 25 Feet Walk Test at Self-selected Speed (Without Exoskeleton)|"Physical demands during the Timed 25 Feet Walk Test will be indicated by energy expenditure. Energy Expenditure (as indicated by VO2-max) will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.~VO2-max, also known as maximal oxygen uptake, is the measurement of the maximum amount of oxygen a person can utilize during exercise."|3 weeks|For two of the subjects not reported, there were technical issues during assessment.|||ml/min/Kg||Standard Deviation|Mean
2571290|NCT02519244|Primary|Speed in the Timed 25 Feet Walk Test at Self-selected Speed (Without Exoskeleton)|This task will ask the subject to walk for 25 feet at comfortable pace with and without exoskeleton. Subjects will wear their exercise or walking shoes and are allowed to use assistive device such as cane or walker if necessary. The start and finish line of the 25 feet test course will be marked with tape on the floor. Additional 5 feet at the end of start and finish will be used for subject to turn around. A chair will be provided next to the start area so the subject may rest. During the test, the subject will walk at his/her comfortable pace without losing balance. A research team member will walk next to the subject for safety.|baseline||||meters per second (m/s)||Standard Deviation|Mean
2571281|NCT02519244|Primary|Physical Demands as Assessed by Energy Expenditure (Which is Indicated by VO2-max as Measured by the Cosmed K4b2) During the Timed 25 Feet Walk Test at Self-selected Speed (Without Exoskeleton)|"Physical demands during the Timed 25 Feet Walk Test will be indicated by energy expenditure. Energy Expenditure (as indicated by VO2-max) will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.~VO2-max, also known as maximal oxygen uptake, is the measurement of the maximum amount of oxygen a person can utilize during exercise."|baseline||||ml/min/Kg||Standard Deviation|Mean
2571282|NCT02519244|Primary|Distance Walked During the Six-minute Walk Test (With Exoskeleton)|Subjects will be asked to walk back and forth in a hallway with or without exoskeleton for 6 minutes. The objective is to cover as much space as possible in 6 minutes. Subjects can slow down or stop to rest if they feel like, but should start walking when they feel they are able. A research team member will walk behind the subject to prevent loss of balance during the test.|3 weeks|For two of the subjects not reported, there were technical issues during assessment.|||meters||Standard Deviation|Mean
2571283|NCT02519244|Primary|Distance Walked During the Six-minute Walk Test (Without Exoskeleton)|Subjects will be asked to walk back and forth in a hallway with or without exoskeleton for 6 minutes. The objective is to cover as much space as possible in 6 minutes. Subjects can slow down or stop to rest if they feel like, but should start walking when they feel they are able. A research team member will walk behind the subject to prevent loss of balance during the test.|3 weeks||||meters||Standard Deviation|Mean
2571284|NCT02519244|Primary|Distance Walked During the Six-minute Walk Test (Without Exoskeleton)|Subjects will be asked to walk back and forth in a hallway with or without exoskeleton for 6 minutes. The objective is to cover as much space as possible in 6 minutes. Subjects can slow down or stop to rest if they feel like, but should start walking when they feel they are able. A research team member will walk behind the subject to prevent loss of balance during the test.|baseline||||meters||Standard Deviation|Mean
2571285|NCT02519244|Primary|Speed in the Timed 25 Feet Walk Test at Fast Speed (With Exoskeleton)|This task will ask the subject to walk for 25 feet at comfortable pace with and without exoskeleton. Subjects will wear their exercise or walking shoes and are allowed to use assistive device such as cane or walker if necessary. The start and finish line of the 25 feet test course will be marked with tape on the floor. Additional 5 feet at the end of start and finish will be used for subject to turn around. A chair will be provided next to the start area so the subject may rest. During the test, the subject will walk at fast speed. A research team member will walk next to the subject for safety.|3 weeks|For two of the subjects not reported, there were technical issues during assessment.|||meters per second (m/s)||Standard Deviation|Mean
2571286|NCT02519244|Primary|Speed in the Timed 25 Feet Walk Test at Fast Speed (Without Exoskeleton)|This task will ask the subject to walk for 25 feet at comfortable pace with and without exoskeleton. Subjects will wear their exercise or walking shoes and are allowed to use assistive device such as cane or walker if necessary. The start and finish line of the 25 feet test course will be marked with tape on the floor. Additional 5 feet at the end of start and finish will be used for subject to turn around. A chair will be provided next to the start area so the subject may rest. During the test, the subject will walk at fast speed. A research team member will walk next to the subject for safety.|3 weeks|One subject did not perform the Timed 25 Feet Walk Test at fast speed because they were only able to walk at the self-selected speed.For one of the subjects not reported, there were technical issues during assessment.|||meters per second (m/s)||Standard Deviation|Mean
2571287|NCT02519244|Primary|Speed in the Timed 25 Feet Walk Test at Fast Speed (Without Exoskeleton)|This task will ask the subject to walk for 25 feet at comfortable pace with and without exoskeleton. Subjects will wear their exercise or walking shoes and are allowed to use assistive device such as cane or walker if necessary. The start and finish line of the 25 feet test course will be marked with tape on the floor. Additional 5 feet at the end of start and finish will be used for subject to turn around. A chair will be provided next to the start area so the subject may rest. During the test, the subject will walk at fast speed. A research team member will walk next to the subject for safety.|baseline|One subject did not perform the Timed 25 Feet Walk Test at fast speed because they were only able to walk at the self-selected speed.|||meters per second (m/s)||Standard Deviation|Mean
2571288|NCT02519244|Primary|Speed in the Timed 25 Feet Walk Test at Self-selected Speed (With Exoskeleton)|This task will ask the subject to walk for 25 feet at comfortable pace with and without exoskeleton. Subjects will wear their exercise or walking shoes and are allowed to use assistive device such as cane or walker if necessary. The start and finish line of the 25 feet test course will be marked with tape on the floor. Additional 5 feet at the end of start and finish will be used for subject to turn around. A chair will be provided next to the start area so the subject may rest. During the test, the subject will walk at his/her comfortable pace without losing balance. A research team member will walk next to the subject for safety.|3 weeks|For two of the subjects not reported, there were technical issues during assessment.|||meters per second (m/s)||Standard Deviation|Mean
2571289|NCT02519244|Primary|Speed in the Timed 25 Feet Walk Test at Self-selected Speed (Without Exoskeleton)|This task will ask the subject to walk for 25 feet at comfortable pace with and without exoskeleton. Subjects will wear their exercise or walking shoes and are allowed to use assistive device such as cane or walker if necessary. The start and finish line of the 25 feet test course will be marked with tape on the floor. Additional 5 feet at the end of start and finish will be used for subject to turn around. A chair will be provided next to the start area so the subject may rest. During the test, the subject will walk at his/her comfortable pace without losing balance. A research team member will walk next to the subject for safety.|3 weeks|For two of the subjects not reported, there were technical issues during assessment.|||meters per second (m/s)||Standard Deviation|Mean
2571329|NCT02518750|Primary|Complete Remission (CR) Rate|All participants who start re-induction Block A therapy are considered evaluable. Any patient who at any time point achieves CR and goes to transplant is considered as a success; or any patient who successfully reaches the end of block C and achieves/remains in CR is considered a success; all other cases are considered as failure.|At the end of each remission re-induction block C (approximately 13 weeks after start of therapy)|Given the very small enrollment number, no statistical analyses was performed.||||||
2571291|NCT02519036|Other Pre-specified|Huntington's Disease (HD) Cognitive Assessment Battery Composite Score|The HD Cognitive Battery was developed as a means of measuring cognitive dysfunction in late premanifest and early manifest HD patients. The 6 tests that comprise the battery were selected based on test sensitivity, practice effects, reliability, domain coverage, feasibility for use in clinical trials, and tolerability. A composite cognitive score was calculated by the average z-score of the 6 individual tests. A positive change from baseline indicated improvement in cognitive function; a negative change indicated worsening. Baseline was defined as the last non-missing measure prior to the first dose.|Baseline to Days 84, 141, and 197|Per protocol set included all participants who were randomized and received all doses of the protocol-specified study drug.|||score on a scale||Standard Deviation|Mean
2571292|NCT02519036|Other Pre-specified|Ventricular Volume as Assessed by Structural Magnetic Resonance Imaging (MRI)||Screening, Days 113, and 197|Per protocol set included all participants who were randomized and received all doses of the protocol-specified study drug.|||mL||Standard Deviation|Mean
2571293|NCT02519036|Other Pre-specified|Change From Baseline in CSF Neurofilament Light Chain Concentration|Baseline was defined as the last non-missing measure prior to the first dose.|Baseline to Final Assessment (Day 85 or 113)|Per protocol set included all participants who were randomized and received all doses of the protocol-specified study drug.|||nanograms per liter (ng/L)||Standard Deviation|Mean
2571294|NCT02519036|Other Pre-specified|Change From Baseline in CSF Mutant Huntingtin (fM) Protein Concentration|Baseline was defined as the last non-missing measure prior to the first dose.|Baseline to Final Assessment (Day 85 or 113)|Per protocol set included all participants who were randomized and received all doses of the protocol-specified study drug.|||ng/mL||Standard Deviation|Mean
2571295|NCT02519036|Other Pre-specified|Time to Maximum Plasma Concentration (Tmax) for ISIS 443139||Days 1 and 85|PK population included all participants who were randomized to ISIS 443139, received at least one dose and had sufficient sampling to permit PK evaluation.|||hour (h)||Full Range|Median
2571296|NCT02519036|Other Pre-specified|Maximum Plasma Concentration (Cmax) for ISIS 443139||Days 1 and 85|PK population included all participants who were randomized to ISIS 443139, received at least one dose and had sufficient sampling to permit PK evaluation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2571297|NCT02519036|Secondary|Observed Cerebrospinal Fluid (CSF) Concentration for ISIS 443139||Days 1, 29, 57, 85, and 113 or 141|Pharmacokinetic (PK) population included all participants who were randomized to ISIS 443139, received at least one dose and had sufficient sampling to permit PK evaluation.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2571298|NCT02519036|Primary|Number of Participants With Treatment-related Adverse Events (TEAEs)|An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered related to the investigational drug product. An AE was to be regarded as a TEAE if it was present prior to receiving the first dose of Study Drug and subsequently worsened or was not present prior to receiving the first dose of Study Drug but subsequently appeared.|Up to approximately 28 weeks|Safety set included all participants who were randomized and received at least one dose of study drug.|||Participants|||Count of Participants
2571299|NCT02519023|Secondary|Maximal Pain Score Patient Felt From 48-72 Hours After Surgery|the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.|48-72 hours after surgery||||units on a scale||Full Range|Median
2571300|NCT02519023|Secondary|Maximal Pain Score for Patient From Time 24-48 Hours After Surgery|the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.|24-48 hours after surgery||||units on a scale||Full Range|Median
2571301|NCT02519023|Secondary|Maximal Pain Score of Patient From Time 0-24 Hours After Surgery|the maximal pain score felt by patient during this time period. This is based on a numerical rating scale of 0-10. 0 is best outcome and 10 is worst outcome.|0-24 hours after surgery||||units on a scale||Full Range|Median
2571302|NCT02519023|Secondary|Patient Satisfaction With Pain Management|number of patients who answered yes to if they were satisfied with their pain management|at 72 hours after surgery||||Participants|||Count of Participants
2571303|NCT02519023|Secondary|Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents|opioid use from time 48-72 hours in mg morphine equivalents|48-72 hours after end of surgery||||mg morphine equivalents||Full Range|Median
2571304|NCT02519023|Secondary|Opioid Used From 24-48 Hours Post Surgery|opioids in mg of morphine equivalents used from 24-48 hours after surgery|24-48 hours after the end of surgery||||mg of morphine equivalents||Full Range|Median
2571305|NCT02519023|Secondary|Number of Patients Admitted Post Operatively||72 hours post-procedure||||Participants|||Count of Participants
2571306|NCT02519023|Secondary|Length of Time in Phase 1 and Phase 2 of Recovery|time from start of recovery until patient was deemed ready to discharge from phase 2 recovery. Phase 2 recovery is the phase of the post anesthesia care where patients are readied to be discharge form the post anesthesia care unit. There are guidelines with regards to when patients are able to be discharged and when those points are met by the patient they are deemed ready to discharge.|an expected average of 120 mins||||hours||Full Range|Median
2571307|NCT02519023|Secondary|Number of Participants With Nausea and Vomiting||72 hours post-procedure||||Participants|||Count of Participants
2571308|NCT02519023|Secondary|Overall Benefit of Analgesia Score (OBAS)|The overall benefit of analgesia score is based off 7 questions given to patients it is scored 0-28. 28 is considered a worse outcome.|72 hours post-procedure||||scores on a scale||Full Range|Median
2571309|NCT02519023|Secondary|Quality of Recovery 15 (QoR15) Score|The quality of recovery is a survey given to patients. It is 15 questions. The scale of the QOR 15 Score is 0 to 150. 150 is a better outcome.|72 hours post-procedure||||scores on a scale||Full Range|Median
2571310|NCT02519023|Secondary|Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents||0-24 post-procedure||||mg of morphine equivalents||Full Range|Median
2571330|NCT02518685|Primary|Proportion of TPS-treated Subjects With Weight Loss ≥ 5% TBL|The proportion of subjects in the TPS group with ≥ 5% TBL is compared to a performance target of 50%|12 months|Per Protocol Population; received TPS Device|||Participants|||Count of Participants
2571311|NCT02519023|Secondary|Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10)|the Numerical rating scale goes from 0 (lowest) to 10 (highest). Higher values are a worse outcome. The maximal number for maximal pain scores from 0-72 hours is 30. Thus the range for this outcome is 0 to 30 with 30 being a worse outcome. This is because the 0-72 hour maximal pain scores are additive from the 0-24, 24-48, and 48-72 hours. Each 24 hour subset has a maximal score of 10 and adding all three results in maximal score of 30.|0-72 hours post-procedure||||scores on a scale||Full Range|Median
2571312|NCT02519023|Primary|Total Opioid Use for Pain Control|total opioid used from time 0 after surgery through 72 hours after surgery was complete.|72 hours||||mg Morphine equivalents||Full Range|Median
2571313|NCT02518997|Primary|Percent of Oxygen Saturation Measurements <85%|Percent of measured oxygen saturations recorded as less than 85%|While the infant is hospitalized, equipment is available and cared for in an incubator, an average of 2-6 weeks|All enrolled infants had measured oxygen saturations at 4 time periods: during reading exposure and 3 hours before reading, 1 hour before reading and 1 hour after reading|||Percent Oxygen saturation measurements|Oxygen saturation measurements|Full Range|Mean
2571314|NCT02518971|Secondary|Incidence of Postoperative Complications|Postoperative complications will be recorded and the incidence will be compared statistically between the two groups.|Up to 31 days postoperative||||Participants|||Count of Participants
2571315|NCT02518971|Secondary|Acute Postoperative Pain Medication Dosages|The dosages of postoperative pain medications will be compared statistically between the two groups.|Postoperative day 1 to day of discharge (1-4 days on average)||||morphine equivalent doses||Standard Deviation|Mean
2571316|NCT02518971|Secondary|Incidence of Surgical Site Infection|Surgical site infection will be recorded (yes/no) and compared statistically between the two groups.|Up to two weeks postoperative||||Participants|||Count of Participants
2571317|NCT02518971|Secondary|Incidence of Discharge to a Skilled Nursing Facility|Discharge to a skilled nursing facility will be recorded (yes/no) and compared statistically between the two groups.|1-4 days postoperative||||Participants|||Count of Participants
2571318|NCT02518971|Secondary|Length of Hospital Stay|Length of hospital stay will be recorded in days and compared statistically between the two groups .|1-4 days postoperative||||days||Standard Deviation|Mean
2571319|NCT02518971|Primary|Number of Patients to Develop Postoperative Urinary Retention (POUR)|Patients who have not developed POUR will have two consecutive, spontaneous urine voids with residual volume of less than 200 mL, as determined by bladder scan or straight catheterization. Patients who do not successfully have the two spontaneous urine voids of less than 200 mL will be considered as having developed POUR. The incidence of POUR will be compared statistically between those taking and not taking tamsulosin at the time of surgery.|Postop day 1||||Participants|||Count of Participants
2571320|NCT02518919|Secondary|Number of Participants Who Were re- Dosed With Sedation Medication|compare the need for additional dosages of sedation medication among three groups|during procedure||||Participants|||Count of Participants
2571321|NCT02518919|Secondary|"Number of Participants With Consultant Satisfaction Rating as Either Not Satisfied, Satisfied, or Very Satisfied,"|Compare consultant satisfaction among three groups using Likert scale|within two hours of completion of procedure||||Participants|||Count of Participants
2571322|NCT02518919|Secondary|Adverse Events|describe the adverse events experienced by study participants secondary to sedation medication and interventions performed to overcome them|during procedure until discharge from the Emergency Department||||Participants|||Count of Participants
2571323|NCT02518919|Secondary|Sedation Efficacy|"compare sedation efficacy among the 3 groups using Ramsey sedation scales and FACES -P (FACES-Pediatric)scale. The Ramsey sedation scales scores sedation at six different levels, according to how arousable the patient is. The continuum of sedation is measured from 1-6 with higher values representing a deeper level of sedation.~Patient is anxious and agitated or restless, or both~Patient is co-operative, oriented, and tranquil~Patient responds to commands only~Patient exhibits brisk response to light glabellar tap or loud auditory stimulus~Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus~Patient exhibits no response The Faces- PScale is a self-report measure used to assess the intensity of children's pain. The scale ranges from 0 to 10 with 0 indicating no hurt or discomfort to 10 :hurts most/worst"|During the Procedure||||scores on a scale||Inter-Quartile Range|Median
2571324|NCT02518919|Primary|Sedation Medication Requirement|Total mg/kg of sedation medication administered IV|Right at the end of the procedure||||mg/kg||Standard Deviation|Mean
2571325|NCT02518750|Secondary|Proportion of Relevant Toxicities|The toxicities of liposomal vincristine (VSLI) when used in combination with chemotherapy will be evaluated. Proportions (probabilities) of relevant toxicities will be estimated with point and interval estimates.|At the completion of therapy (up to approximately 5 months after the start of therapy)|Given the very small enrollment number, no statistical analyses was performed.||||||
2571326|NCT02518750|Secondary|Block C Minimal Residual Disease (MRD)|MRD will be studied after each cycle of therapy. MRD is considered as positive (i.e., prevalent) if its level is ≥0.01% for ALL. The prevalence of MRD at end of each cycle is defined as proportion of MRD positives; we will estimate these proportions with point and interval estimates.|At the end of Block C therapy (approximately 13 weeks after start of therapy)|No participant received Block C therapy.||||||
2571327|NCT02518750|Secondary|Block B Minimal Residual Disease (MRD)|MRD will be studied after each cycle of therapy. MRD is considered as positive (i.e., prevalent) if its level is ≥0.01% for ALL. The prevalence of MRD at end of each cycle is defined as proportion of MRD positives; we will estimate these proportions with point and interval estimates.|At the end of Block B therapy (approximately 10 weeks after start of therapy)|No participant received Block B therapy.||||||
2571328|NCT02518750|Secondary|Block A Minimal Residual Disease (MRD)|MRD will be studied after each cycle of therapy. MRD is considered as positive (i.e., prevalent) if its level is ≥0.01% for ALL. The prevalence of MRD at end of each cycle is defined as proportion of MRD positives; we will estimate these proportions with point and interval estimates.|At the end of Block A therapy (approximately 5 weeks after start of therapy)|Given the very small enrollment number, no statistical analyses was performed.||||||
2571331|NCT02518685|Primary|Mean Percent Total Body Weight Loss (% TBL) Between the TPS and the Control Group|The mean percent Total Body Weight Loss (% TBL) is the percentage weight change at 12 Months from Baseline|12 Months||||% Total Body Weight Loss||Standard Error|Least Squares Mean
2571332|NCT02518620|Primary|Number and Percentage of Subjects With DAS28 Using C-reactive Protein (CRP) < 2.6, Low, Moderate or High Disease Activity Based on DAS28(CRP)|"DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln[CRP+1]) + (0.014 × VASPA) + 0.96~DAS28(CRP) < 2.6~Low disease activity = 2.6 ≤ DAS28 ≤ 3.2~Moderate disease activity = 3.2 < DAS28 ≤ 5.1~High disease activity = DAS28 > 5.1~Disease activity based on DAS28(CRP) was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported."|At Weeks 0, 12, 48, and 104|ITO Population|||Participants|||Count of Participants
2571333|NCT02518620|Primary|Number and Percentage of Subjects in Remission or With Low, Moderate or High Disease Activity Based on Disease Activity Score Using 28 Joint Counts (DAS28) Using Estimated Sedimentation Rate (ESR)|"DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln[ESR]) +(0.014 × VASPA)~Remission = DAS28(ESR) < 2.6~Low disease activity = 2.6 ≤ DAS28 ≤ 3.2~Moderate disease activity = 3.2 < DAS28 ≤ 5.1~High disease activity = DAS28 > 5.1~Disease activity based on DAS28(ESR) was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported."|At Weeks 0, 12, 48, and 104|ITO Population|||Participants|||Count of Participants
2571334|NCT02518620|Primary|ACR-N Index of Improvement|"The ACR-N Index of Improvement is defined as the minimum of the following 3 criteria:~The percent improvement from Week 0 in TJCs~The percent improvement from Week 0 in SJCs~The median percent improvement from Week 0 for the following 5 assessments:~Subject's assessment of pain (VAS)~Subject's global assessment of disease activity (VASPHA)~Physician's global assessment of disease activity (VASPHA)~Subject's assessment of physical function as measured by the HAQ-DI~CRP level~ACR-N Index of Improvement was measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported."|At Weeks 0, 12, 48, and 104|ITO Population|||percent improvement||Standard Error|Mean
2571335|NCT02518620|Primary|Number and Percentage of Subjects With ACR70 Response.|"ACR70 response is defined as:~70% improvement in TJC (68 joints) relative to Week 0 AND~70% improvement in SJC (66 joints) relative to Week 0 AND~70% improvement in 3 of the following 5 areas relative to Week 0:~Subject's Assessment of Pain (100 mm - VAS)~Subject's Global Assessment of Disease Activity (VASPA)~Physician's Global Assessment of Disease Activity (VASPHA)~Subject's assessment of physical function as measured by HAQ-DI~CRP level~ACR70 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported."|At Weeks 0, 12, 48, and 104|ITO Population|||Participants|||Count of Participants
2571336|NCT02518620|Primary|Number and Percentage of Subjects With ACR50 Response.|"ACR50 response is defined as:~50% improvement in TJC (68 joints) relative to Week 0 AND~50% improvement in SJC (66 joints) relative to Week 0 AND~50% improvement in 3 of the following 5 areas relative to Week 0:~Subject's Assessment of Pain (100 mm - VAS)~Subject's Global Assessment of Disease Activity (VASPA)~Physician's Global Assessment of Disease Activity (VASPHA)~Subject's assessment of physical function as measured by HAQ-DI~CRP level~ACR50 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported."|At Weeks 0, 12, 48, and 104|ITO Population|||Participants|||Count of Participants
2571337|NCT02518620|Primary|Number and Percentage of Subjects With American College of Rheumatology (ACR) 20 Response.|"ACR 20 response is defined as:~20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND~20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND~20% improvement in 3 of the following 5 areas relative to Week 0:~Subject's Assessment of Pain (100 mm - visual analogue scale [VAS])~Subject's Global Assessment of Disease Activity (VASPA)~Physician's Global Assessment of Disease Activity (VASPHA)~Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI)~C-reactive protein (CRP) level~ACR20 responses were measured at Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, and 104 and Weeks 0, 12, 48, and 104 reported."|At Weeks 0, 12, 48, and 104|ITO Population|||Participants|||Count of Participants
2571338|NCT02518464|Primary|Total Number of Responders|"A participant will be considered to have achieved the primary efficacy endpoint (a Responder) if she/he has >50% reduction in the number of monthly headache days during the month of therapy compared with participant's own baseline. If there is < 50% reduction in the number of migraine days, she/he will be considered a Non-Responder."|1 month from baseline||||Participants|||Count of Participants
2571339|NCT02518139|Primary|Adverse Events: Frequency and Severity|To assess the safety and tolerability of TD-4208 by assessing the frequency and severity of Treatment Emergent Adverse Events (TEAE)|Baseline to Day 365||||Participants|||Count of Participants
2571340|NCT02518113|Secondary|Phase 2: Change From Baseline in the Functional Assessment of Cancer Therapy-Leukemia-General (FACT-Leu-G) Score||Baseline, End of Study (Approximately 1.5 Years)|Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.||||||
2571341|NCT02518113|Secondary|Phase 2: Overall Survival (OS)||Baseline to the Date of Death from Any Cause (Approximately 1.5 Years)|Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.||||||
2571342|NCT02518113|Secondary|Phase 2: Event Free Survival (EFS)||Baseline to Objective Disease Progression or Death from Any Cause (Approximately 1 Year)|Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.||||||
2571343|NCT02518113|Secondary|Phase 2:Relapse Free Survival (RFS)||Date of CR to Relapse or Death from any Cause (Approximately 1 Year)|Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.||||||
2571344|NCT02518113|Secondary|Phase 2: Duration of Remission (DoR)||Date of CR, CRi, or PR to Date of Relapse or Death from Any Cause (Approximately 1 Year)|Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.||||||
2571345|NCT02518113|Secondary|Phase 2: Number of Participants Who Achieve PR||Baseline to Objective Disease Progression (Up To 12 Months)|Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.||||||
2571346|NCT02518113|Secondary|Phase 2: Number of Participants Who Achieve CR, CRi or Partial Remission (PR): Overall Remission Rate (ORR) Plus PR||Baseline to Objective Disease Progression (Up To 12 Months)|Zero participants analyzed. There were no participants enrolled in Phase 2 of the study.||||||
2571368|NCT02517866|Secondary|Percentage of Participants With BP <130/80 mmHg at Week 12|Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.|Week 12|FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.|||percentage of participants||99% Confidence Interval|Number
2571347|NCT02518113|Secondary|Number of Participants With CR or CRi and Notch-1 or FBXW7 Mutations|ORR is defined as the number of participants who achieved a best overall response of either complete remission (CR) or incomplete remission (CRi). The ORR (CR and CRi) is the sum of participants achieving a CR or a CRi divided by the total number of participants randomized in that arm. CR is defined as the number of participants who achieved a best overall response of complete remission (CR), out of the total number of participants randomized in that arm.|Baseline to Objective Disease Progression (Up To 12 Months)|All participants who received at least one dose of study drug in Part A.|||Participants|||Count of Participants
2571348|NCT02518113|Secondary|Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0- 48]) of LY3039478 in Combination With Dexamethasone in Day 8|Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0- 48]) of LY3039478 in Combination with Dexamethasone in Day 8|Cycle 1 Day 8: Predose, 1-2, 3-4,6-8,24-30 hours|All participants who received at least one dose of study drug in Part A and had evaluable PK data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2571349|NCT02518113|Secondary|Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0-∞]) of LY3039478 in Combination With Dexamethasone in Day 1|Pharmacokinetics (PK): Area Under the Concentration-Time Curve (AUC[0-∞]) of LY3039478 in Combination with Dexamethasone in Day 1|Cycle 1 Day 1: Predose, 1-2, 3-4,6-8,24-30 hours|All participants who received at least one dose of study drug in Part A and had evaluable PK data.|||nanogram hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2571350|NCT02518113|Primary|Number of Participants Who Achieve Complete Remission (CR) or CR With Incomplete Blood Count Recovery (CRi): Overall Remission Rate (ORR)|ORR is defined as the number of participants who achieved a best overall response of either complete remission (CR) or incomplete remission (CRi). The ORR (CR and CRi) is the sum of patients achieving a CR or a CRi divided by the total number of patients randomized in that arm. CR is defined as the number of participants who achieved a best overall response of complete remission (CR), out of the total number of participants randomized in that arm.|Baseline to Objective Disease Progression (Up To 2 Months)|All participants who received at least one dose of study drug in Part A.|||Participants|||Count of Participants
2571351|NCT02518113|Primary|Recommended Dose of LY3039478 in Combination With Dexamethasone|A DLT was an Adverse Event(AE) observed during the first 28 day cycle that is determined by the investigator to be at least possibly related to LY3039478 according to CTCAE v 4.0 and fulfills any of the following criteria:CTCAE Grade 3 nonhematological toxicity with a few exceptions, any other significant toxicity deemed to be dose limiting.A dose-limiting equivalent toxicity (DLET) was defined as an AE occurring between Day 1 and Day 28 of any cycle (other than Cycle 1) for a patient enrolled in the Phase 1 portion or in any cycle (including Cycle 1) for a patient enrolled in the Phase 2 portion that would have met the criteria for DLT if it had occurred during Cycle 1 for a patient enrolled in the Phase 1 portion.|Cycle 1 (28 Days)|All participants who received at least one dose of study drug in Part A.|||mg|||Number
2571352|NCT02518113|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|A DLT was an Adverse Event(AE) observed during the first 28 day cycle that is determined by the investigator to be at least possibly related to LY3039478 according to CTCAE v 4.0 and fulfills any of the following criteria: CTCAE Grade 3 nonhematological toxicity with a few exceptions, any other significant toxicity deemed to be dose limiting (eg, any toxicity that is possibly related to the study medication that requires the withdrawal of the patient from the study during Cycle 1).|Cycle 1 (Up To 28 Days)|All participants who received at least one dose of study drug in Part A.|||Participants|||Count of Participants
2571353|NCT02518048|Secondary|Change in Total Skin Thickness and Echo-poor Band Thickness From Baseline to EoT|"Skin thickness ultrasound measurements of the test sites were performed at Baseline and End of Treatment.~Two skin parameters were calculated using ultrasound:~The mean total skin thickness~The mean echo-poor band thickness"|Baseline to End of Treatment||||millimeters||Standard Deviation|Mean
2571354|NCT02518048|Secondary|Change in Score of Erythema, Scaling, and Infiltration at Individual Visits|"The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale with half-mark values from 0 (no evidence) to 3.0 (severe).~Erythema: 0 (no evidence - normal skin color) to 3 (severe - intense red). Scaling: 0 (no evidence - no scaling) to 3 (severe - coarse, thick scales). Infiltration: 0 (no evidence - no infiltration) to 3 (severe - very marked infiltration)."|Day 1 (Baseline) to Day 29||||units on a scale||Standard Deviation|Mean
2571355|NCT02518048|Secondary|Change in TCS at Individual Visits||Day 1 (Baseline) to Day 29||||units on a scale||Standard Deviation|Mean
2571356|NCT02518048|Primary|Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, Infiltration) Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling, and Infiltration) at End of Treatment Compared to Baseline|"The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale with half-mark values from 0 (no evidence) to 3.0 (severe).~The total TCS was calculated for each test site by summing the scores for erythema, scaling, and infiltration for that particular test site.~Each test site was assessed at Baseline and on Days 4, 8, 11, 15, 18, 22, 25, and 29 (EoT).~The mean TCS at Baseline was 6.6 for both groups."|Day 1 (Baseline) to Day 29||||units on a scale||Standard Deviation|Mean
2571357|NCT02517996|Primary|Change in Pelvic Urgency, Pain, and Frequency (PUF) Questionnaire With Preemptive Pudendal Nerve Block Compared to Saline|"To determine the change in pelvic urgency, pain and frequency (PUF) questionnaire at baseline, 2 hours, 2 weeks, 6 weeks and 3 months after hydrodistention with preemptive pudendal nerve block (1% Lidocaine) compared to hydrodistention with placebo (saline).~The Pelvic Urgency, Pain, and Frequency Patient Symptom Scale asks 11 questions, 7 on PUF symptoms, 4 on how bothersome PUF symptoms are. Symptom questions include 3, 4, or 5 ranked answers, with higher answers indicating more voids, or greater frequency of pain. The bother questions each of 4 ranked answers from 0-never, to 3-always. The symptom score is added, the bother score is added, and then the total score is added. The total PUF score is then reported. The minimum score is 0 and the maximum score is 35, and a higher score indicates greater symptoms and higher bother from pelvic pain and frequency."|Baseline, 2 hours, 2 weeks, 6 weeks, 3 months (Up to 3 months)|Loss to follow up of 3 participants in the Normal Saline group|||score on a scale||Standard Deviation|Mean
2572953|NCT02500537|Secondary|Staple Line Assessment: Duration of Leakage, Post-Op|Duration of leakage based on chest tube drainage in days|Participants will be followed for the duration of hospital stay, on average up to 5 days|Thoracic patients only|||days||Standard Deviation|Mean
2571358|NCT02517996|Primary|Change in Problem Index (O'Leary Sant) With Preemptive Pudendal Nerve Block Compared to Saline|"To determine the change in problem index (O'Leary Sant) at baseline, 2 hours, 2 weeks, 6 weeks and 3 months after hydrodistention with preemptive pudendal nerve block (1% Lidocaine) compared to hydrodistention with placebo (saline).~The IC problem index questionnaire consists of 4 questions on how much of a problem a patient's IC symptoms cause them. Each question has 5 answer choices ranging from 0-no problem, to 4-big problem. The numerical score for each question are added together, with a minimum score of 0 and a maximum score of 16. A higher score indicates that IC symptoms cause more problems for the patient."|Baseline, 2 hours, 2 weeks, 6 weeks, 3 months (Up to 3 months)|Loss to follow up of 2 participants in the Normal Saline group|||score on a scale||Standard Deviation|Mean
2571359|NCT02517996|Primary|Change in IC Symptom Index Questionnaire With Preemptive Pudendal Nerve Block Compared to Saline|"To determine the change in interstitial cystitis symptom index at baseline, 2 hours, 2 weeks, 6 weeks and 3 months after hydrodistention with preemptive pudendal nerve block (1% Lidocaine) compared to hydrodistention with placebo (saline).~The IC symptom index questionnaire consists of 4 questions on IC symptoms. 2 of the questions have 6 answer choices ranging from 0-never, to 5-almost always. 1 question has 6 answer choices ranging from 0-never to 5-usually. 1 question has 7 answer choices ranging from 0-never to 6-5 or more times. The numerical score for each question are added together, with a minimum score of 0 and a maximum score of 21. A higher score indicates greater severity of IC symptoms."|Baseline, 2 weeks, 6 weeks, 3 months (Up to 3 months)|Loss to follow up of 2 participants in the Normal Saline group|||score on a scale||Standard Deviation|Mean
2571360|NCT02517996|Primary|Change in Pain Level as Assessed by the Visual Analog Scale (VAS)|"To determine the change in pain at 2 hours, 2 weeks, 6 weeks, and 3 months postoperatively in patients undergoing hydrodistention with preemptive pudendal nerve block (1% Lidocaine) compared to hydrodistention with placebo (saline) using the visual analog scale (VAS).~VAS consists of a 10cm horizontal line with the minimum endpoint labeled no pain (0) and maximum labeled worst pain ever (10). Patients placed a mark on the point that corresponds to the level of pain severity they felt. The cm distance from the low end of the VAS to the patient's mark is used as the numerical index of the intensity of pain. Pain scores of 3.0-5.4 cm are moderate, over 5.4 indicates severe pain."|Baseline, 2 hours, 2 weeks, 6 weeks, 3 months (Up to 3 months)|Loss to follow up of 2 participants in the Normal Saline group|||score on a scale||Standard Deviation|Mean
2571361|NCT02517866|Secondary|"Change From Baseline in DBP at Week 12 in Treatment-Naïve Participants"|At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, BHT and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.|Baseline and Week 12|FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were analysed for this outcome measure.|||mmHg||Standard Deviation|Mean
2571362|NCT02517866|Secondary|Change From Baseline in DBP at Week 12|At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, BHT and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.|Baseline and Week 12|FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were analysed for this outcome measure.|||mmHg||Standard Error|Least Squares Mean
2571363|NCT02517866|Secondary|"Change From Baseline in Trough Sitting SBP at Week 12 in Treatment-Naïve Participants"|At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, baseline hypertension therapy (BHT) and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.|Baseline and Week 12|FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.|||mmHg||Standard Deviation|Mean
2571364|NCT02517866|Secondary|Change From Baseline in Trough Sitting SBP at Week 12|At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer. Change from Baseline was estimated using an ANCOVA model with fixed effects, country, baseline hypertension therapy (BHT) and baseline SBP (or DBP) included as a covariate. A negative change from baseline indicates improvement.|Baseline and Week 12|FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.|||mmHg||Standard Error|Least Squares Mean
2571365|NCT02517866|Secondary|Percentage of Participants With BP <140/90 mmHg at Week 12|Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.|Week 12|FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.|||percentage of participants||99% Confidence Interval|Number
2571366|NCT02517866|Secondary|Percentage of Participants With DBP <80 mmHg at Week 12|Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.|Week 12|FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.|||percentage of participants||99% Confidence Interval|Number
2571367|NCT02517866|Secondary|Percentage of Participants With SBP <130 mmHg at Week 12|Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.|Week 12|FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.|||percentage of participants||99% Confidence Interval|Number
2571540|NCT02515045|Primary|Change From Baseline (Preoperative Exam) in Macular Thickness|Macula is the area in the retina that is responsible for the best central vision. Changes in its thickness may occur after cataract surgery due to the normal inflammatory process that occurs postoperatively but it returns to preoperative values unless there is an underlying disease.|Month 1.||||Microns||Standard Deviation|Mean
2571370|NCT02517866|Secondary|Percentage of Participants With Diastolic Blood Pressure (DBP) <85 mmHg at Week 12|Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.|Week 12|FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.|||percentage of participants||99% Confidence Interval|Number
2571371|NCT02517866|Secondary|Percentage of Participants With Systolic Blood Pressure (SBP) <140 mmHg at Week 12|Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.|Week 12|FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.|||percentage of participants||99% Confidence Interval|Number
2571372|NCT02517866|Secondary|Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <130/80 mmHg|At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.|Weeks 6 and 12|FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received thiazides before baseline and are evaluable for this outcome measure.|||percentage of participants||99% Confidence Interval|Number
2571373|NCT02517866|Secondary|Percentage of Participants Treated With ACE Inhibitors or Other ARBs Before Baseline Reaching BP <130/80 mmHg|At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.|Weeks 6 and 12|FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received ACE inhibitors or other ARBs before baseline and are evaluable for this outcome measure.|||percentage of participants||99% Confidence Interval|Number
2571374|NCT02517866|Secondary|Percentage of Participants Treated With CCB Before Baseline Reaching BP <130/80 mmHg|At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.|Weeks 6 and 12|FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received CCB before baseline and are evaluable for this outcome measure.|||percentage of participants||99% Confidence Interval|Number
2571375|NCT02517866|Secondary|"Percentage of Treatment-Naïve Participants Reaching BP <130/80 mmHg"|Treatment-naïve participants are defined as participants who have not received anti-hypertensive treatment for at least four weeks prior to screening. At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.|Up to Week 12|FAS included all participants who took at least 1 dose of azilsartan medoxomil.|||percentage of participants||99% Confidence Interval|Number
2571376|NCT02517866|Secondary|Percentage of Participants Treated With Thiazides Before Baseline Reaching BP <140/85 mmHg|At each visit three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.|Weeks 6 and 12|FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received thiazides before baseline and are evaluable for this outcome measure.|||percentage of participants||99% Confidence Interval|Number
2571377|NCT02517866|Secondary|Percentage of Participants Treated With Angiotensin Converting Enzyme (ACE) Inhibitors or Other Angiotensin Receptor Blockers (ARBs) Before Baseline Reaching BP <140/85 mmHg|At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.|Weeks 6 and 12|FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received ACE inhibitors or other ARBs before baseline and are evaluable for this outcome measure.|||percentage of participants||99% Confidence Interval|Number
2571378|NCT02517866|Secondary|Percentage of Participants Treated With Calcium Channel Blocker (CCB) Before Baseline Reaching BP<140/85 mmHg|At each visit three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.|Weeks 6 and 12|FAS included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using LOCF method. Here, number of participants analyzed is the participants who received CCB before baseline and are evaluable for this outcome measure.|||percentage of participants||99% Confidence Interval|Number
2571379|NCT02517866|Secondary|"Percentage of Treatment-Naïve Participants Reaching BP <140/85 mmHg"|Treatment-naïve participants are defined as participants who have not received anti-hypertensive treatment for at least four weeks prior to screening. At each visit 3 serial BP measurements were determined while the participant was seated, with a sphygmomanometer.|Up to Week 12|FAS included all participants who took at least 1 dose of azilsartan medoxomil.|||percentage of participants||99% Confidence Interval|Number
2571380|NCT02517866|Primary|Percentage of Participants With Blood Pressure (BP) <140/85 mmHg (Systolic BP <140 mmHg and Diastolic BP <85 mmHg) by Clinic-Measured Sitting BP at Week 12|Three serial BP measurements were determined while the participant was seated, with a sphygmomanometer.|Week 12|Full analysis set (FAS) included all participants who took at least 1 dose of azilsartan medoxomil. Missing data was computed using last observation carried forward (LOCF) method. Here, number of participants analyzed is the total number of participants who were evaluable for this outcome measure.|||percentage of participants||99% Confidence Interval|Number
2571381|NCT02517658|Primary|Difference in Answers to Pre & Post Teaching Questionnaires|Assessing the difference in how parents answered the questionnaire before receiving any discharge instructions and the questionnaire after watching the video or receiving standard discharge instructions by the nurse. Parents completed pre-instruction and post-instruction assessments of their knowledge of post-operative pain management, with responses scored on a 0-8 scale by assigning 1 point to each correct response out of 8 multiple-choice questions. Higher difference score means that the parents answered more questions correctly after the teaching/video.|approx. 1 - 2 hrs post-op||||difference in testing scores||Inter-Quartile Range|Median
2571382|NCT02517580|Secondary|Change From Baseline in Blood Concentration of Dephosphorylated-uncarboxylated Matrix Gla Protein (Dp-ucMGP) at 8 Weeks||8 weeks|||||||
2571383|NCT02517580|Secondary|Change From Baseline in Augmentation Index by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks||8 weeks|||||||
2571386|NCT02517567|Primary|Tear Film Evaporation Rate|Tear film evaporation rate (amount of tears (grams or g) that evaporates over a surface area (m2) per hour (h)) assessment was performed using the VapoMeter as a non-invasive measurement of tear film evaporation over 10 seconds. Measurements were taken on both the right and left eyes after 8 hours of lens wear or no lens wear, as applicable. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.|Day 1, Hour 8, each product|This analysis population includes all randomized subjects (Intent-to-Treat). To address the primary objective of comparing Lens vs. No Lens, results from all 3 study lenses are combined. Therefore, subjects (eyes) are counted multiple times in Lens group due to crossover design and number of eyes with non-missing response is reported.|||gm^-2 h|Eyes|Standard Deviation|Mean
2571387|NCT02517541|Primary|Leakage Under the Baseplate (cm^2)|The leakage area was measured using photos of used baseplates. A computer program was used to measure the leakage area.|14 weeks (2 weeks baseline + 12 weeks intervention)||||cm2|baseplates|Standard Deviation|Mean
2571388|NCT02517528|Secondary|Percentage of Participants With Virologic Relapse by Post-Treatment Week 24|Virologic relapse is defined as confirmed HCV RNA greater than or equal to LLOQ between end of treatment and 24 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA less than LLOQ at the end of treatment. Completion of treatment is defined as a study drug duration greater than or equal to 77 days. 95% CI is calculated using Wilson's score method.|Within 24 weeks after the last dose of study drug|Intent-to-Treat Population: all enrolled participants who received at least one dose of study drug. Only completers (ie, participants who were dosed with study drug at least 77 days) were included.|||percentage of participants||95% Confidence Interval|Number
2571389|NCT02517528|Secondary|Percentage of Participants With Virologic Relapse|Virologic relapse is defined as confirmed HCV RNA greater than or equal to LLOQ between end of treatment and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA less than LLOQ at the end of treatment. Completion of treatment is defined as a study drug duration greater than or equal to 77 days. 95% CI is calculated using Wilson's score method.|Within 12 weeks after the last dose of study drug|Intent-to-Treat Population: all enrolled participants who received at least one dose of study drug. Only completers (ie, participants who were dosed with study drug at least 77 days) were included.|||percentage of participants||95% Confidence Interval|Number
2571390|NCT02517528|Secondary|Percentage of Participants With On Treatment Virologic Failure|On treatment virologic failure is defined as confirmed HCV RNA greater than or equal to the LLOQ at any point during treatment after HCV RNA less than LLOQ, confirmed increase from the lowest value post-baseline in HCV RNA (two consecutive HCV RNA measurements greater than 1 log10 IU/mL above the lowest value post-baseline) at any time point during treatment, or HCV RNA greater than or equal to LLOQ persistently during treatment with at least 6 weeks (greater than or equal to 36 days) of treatment. 95% CI is calculated using Wilson's score method.|Within 12 weeks after first dose of study drug|Intent-to-Treat Population: all enrolled participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2571391|NCT02517528|Primary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)|SVR24 is defined as HCV RNA less than the LLOQ at 24 weeks following therapy. 95% CI is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority. SVR24 is primary outcome measure only for China.|24 weeks after last dose of study drug|Intent-to-Treat Population: all enrolled participants who received at least one dose of study drug. Participants with missing data were imputed as failures.|||percentage of participants||95% Confidence Interval|Number
2571392|NCT02517528|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)|SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) at 12 weeks following therapy. 95% confidence interval (CI) is calculated using Wilson's score method. The lower bound of the 95% CI for the percentage of participants with SVR12 must exceed 67% to achieve superiority.|12 weeks after last dose of study drug|Intent-to-Treat Population: all enrolled participants who received at least one dose of study drug. Participants with missing data were imputed as failures.|||percentage of participants||95% Confidence Interval|Number
2571393|NCT02517515|Secondary|Percentage of Participants With Post-treatment Relapse by Post-treatment Week 24|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 24 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 24 weeks after the last dose of active study drug|All participants who received at least 1 dose of active study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit, who had HCV RNA data available during the SVR24 period.|||percentage of participants||95% Confidence Interval|Number
2571394|NCT02517515|Secondary|Percentage of Participants With Post-treatment Relapse by Post-treatment Week 12|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of active study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of active study drug|All participants who received at least 1 dose of active study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit, who had HCV RNA data available during the SVR12 period.|||percentage of participants||95% Confidence Interval|Number
2571395|NCT02517515|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during active treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during active treatment; or all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of active treatment.|up to 12 weeks|All participants who received at least 1 dose of active study drug.|||percentage of participants||95% Confidence Interval|Number
2571459|NCT02516410|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 12|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Through Week 12|FAS included all randomized participants who received at least 1 dose of study drug.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2571396|NCT02517515|Primary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)|SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was superiority of the percentage of treatment-naïve and treatment-experienced HCV subgenotype 1b (GT1b)-infected participants treated with 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) who achieved SVR24 compared with the historical control rate for comparable patients treated with telaprevir (TVR) plus pegylated interferon (pegIFN) and RBV.|24 weeks after the last actual dose of active study drug|All treatment-naïve and treatment-experienced participants who received at least 1 dose of active study drug; participants with missing data after backward imputation were counted as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2571397|NCT02517515|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of active study drug. The primary efficacy endpoint was superiority of the percentage of treatment-naïve and treatment-experienced HCV subgenotype 1b (GT1b)-infected participants treated with 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 once daily] and dasabuvir [250 mg twice daily]) who achieved SVR12 compared with the historical control rate for comparable patients treated with telaprevir (TVR) plus pegylated interferon (pegIFN) and RBV.|12 weeks after the last actual dose of active study drug|All treatment-naïve and treatment-experienced participants who received at least 1 dose of active study drug; participants with missing data after backward imputation were counted as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2571398|NCT02517463|Secondary|Change in the Length of the Index Menstrual Cycle From Baseline|shortening or lengthening of the index menstrual cycle compared to the previous menstrual pattern of the subject|one cycle (i.e. up to about 4 weeks)|Only subjects with follow-up information were included in this part of analysis|||days||Inter-Quartile Range|Median
2571399|NCT02517463|Secondary|Failure Rate|Number of subjects who got pregnant / Total number of subjects in the group|one cycle (i.e. up to about 4 weeks)||||percentage of participants|||Number
2571400|NCT02517463|Primary|Percentage of Pregnancies Prevented (PPP)||one cycle (i.e. up to about 4 weeks)||||percentage of pregnancies prevented|||Number
2571401|NCT02517268|Secondary|Incidence of Post-operative Complications (DGE, Anastomotic Leaks, Intra-abdominal Abscesses, Wound Infection, UTI, Respiratory Compromise, Renal Failure, Etc.)||30 days after operation||||Participants|||Count of Participants
2571402|NCT02517268|Secondary|Readmission Rate||30 days after operation||||Participants|||Count of Participants
2571403|NCT02517268|Secondary|Cost|Cost will be assessed by reviewing inpatient hospital charges|30 days after operation||||US Dollar||Full Range|Median
2571404|NCT02517268|Secondary|Post-operative Median Length of Stay||30 days after operation||||days||Full Range|Median
2571405|NCT02517268|Primary|Percentage of Patients Discharged by Post-operative Day 5|Two-sided alpha 0.05 will be used to detect a increase in the percentage of patients discharged on post-operative day 5|Up to post-operative day 5||||Participants|||Count of Participants
2571406|NCT02517047|Secondary|Forced Expiratory Volume|Forced expiratory volume measured in liters is the volume of air which can be forcibly exhaled from the lungs in the first second of a forced expiration and helps with evaluation of asthma control. FEV1 was only measure at baseline to assess the participants asthma status at baseline.|Baseline||||liters||Standard Deviation|Mean
2571407|NCT02517047|Secondary|Asthma Symptoms|Asthma symptom control as a measure of effectiveness of self-management behavior on asthma control, measured by Asthma Control Test (ACT). Asthma control test is a survey used to evaluate asthma control in patients. It includes 5 multiple questions that ask about how much of the time patient was having asthma symptoms. The higher the score the better asthma control. Lower scores especially less than 19 represent poor asthma control. each question has 5 answers. The total score is the sum of all the scores from 5 questions. the maximum score on the test is 25 which is excellent asthma control and the lowest is 0 which defines extremely poor asthma control.|12 weeks||||units on a scale||Standard Deviation|Mean
2571408|NCT02517047|Primary|Number of Participants With Rescue Inhaler Use|Total number participants with rescue inhaler use throughout the course of the study.|12 weeks||||Participants|||Count of Participants
2571409|NCT02517047|Primary|Number of Participants With Daily Medication Compliance|Total number participants who took their medication as planned will be measured. This will include measuring the number of participants with medication compliance who take their medications as planned based on the data from the monitoring device.|12 weeks||||Participants|||Count of Participants
2571410|NCT02517021|Secondary|Percentage of Patients With no Significant Nausea (VAS <25 mm) During the Overall Phase||0-120 hours||||Participants|||Count of Participants
2571411|NCT02517021|Secondary|Percentage of Patients With no Significant Nausea (VAS <25 mm) During the Delayed Phase||>24-120 hours||||Participants|||Count of Participants
2571412|NCT02517021|Secondary|Percentage of Patients With no Significant Nausea (VAS <25 mm) During the Acute Phase||0-24 hours||||Participants|||Count of Participants
2571413|NCT02517021|Secondary|Percentage of Patients With no Emetic Episodes in the Overall Phase||0-120 hours||||Participants|||Count of Participants
2571414|NCT02517021|Secondary|Percentage of Patients With no Emetic Episodes in the Delayed Phase||>24-120 hours||||Participants|||Count of Participants
2571415|NCT02517021|Secondary|Percentage of Patients With no Emetic Episodes in the Acute Phase||0-24 hours||||Participants|||Count of Participants
2571416|NCT02517021|Secondary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase||0-120 hours||||Participants|||Count of Participants
2571417|NCT02517021|Secondary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase||>24-120 hours||||Participants|||Count of Participants
2571418|NCT02517021|Secondary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase||0-24 hours||||Participants|||Count of Participants
2571537|NCT02515058|Primary|% Vital Bone Formation (Histological)|histologic determination of % of vital bone formation|3 months after ridge preservation||||percentage||Standard Deviation|Mean
2571419|NCT02517021|Primary|Percentage of Patients With Adverse Events|This is a safety study where Adverse Events is the primary outcome (defined by the current ICH Guideline for Good Clinical Practice). Patients are randomized according to a 1:1 ratio (IV NEPA FDC : oral NEPA FDC). No formal comparison is planned, the presence of a control in the same patient population helps interpret any unexpected safety finding in the experimental arm. It is expected that the number of patients randomized to the test group, i.e., 200, will allow approximately 100 patients to be treated with the test drug for 4 cycles. Based on 100 patients treated at Cycle 4 with the IV NEPA FDC , if a given Adverse Event (AE) is not observed, an AE incidence of 3% or greater can be excluded with 95% confidence.|Participants will be followed for the duration of the chemotherapy, an expected average duration of up to 14 weeks assuming a maximum of 4 chemotherapy cycles given every 3 weeks.||||Participants|||Count of Participants
2571420|NCT02516982|Secondary|Number of Requests for Technical Assistance by Type of Request and According to Survey Layout|This outcome was only measured in the Screening - Scrolling layout and in the Screening - Paging layout groups. Total number of requests for technical assistance made in each experimental group according to type of request.|One-off outcome assessment conducted up to 24 hours after obtaining written, informed consent||||Requests for technical assistance|Requests for technical assistance||Number
2571421|NCT02516982|Secondary|Proportion of Participants Requesting Technical Assistance According to Survey Layout|This outcome was only measured in the Screening - Scrolling layout and in the Screening - Paging layout groups. Number of participants who made no requests for technical assistance, and those who requested technical assistance|One-off assessment immediately after recruitment||||Participants|||Count of Participants
2571422|NCT02516982|Secondary|Time Needed to Complete the Whooley Questions and the EPDS According to Survey Layout|This outcome was only measured in the Screening - Scrolling layout and in the Screening - Paging layout groups. Time elapsed (in seconds) between the participants starting to read the basic instructions on how to complete the survey questionnaires and the participant completing the EPDS. These actions will be indicated by participants pressing the Start button on the device screen and when a message acknowledging that they have completed the survey questionnaires is displayed on the device screen. This component will be broken down further into the individual survey questionnaires that participants will be required to complete (i.e., personal demographic information, Whooley questions, and EPDS). In addition, we will account for the time that participants spend experiencing problems, distractions or making requests for help or clarification.|One-off assessment immediately after recruitment||||Seconds||Full Range|Median
2571423|NCT02516982|Primary|Adherence With a 6-month Follow-up Protocol|This outcome was measured on the retrospective plus momentary assessment and retrospective assessment groups only. Participants who completed at least one expected assessment during each sampling period|6 months||||Participants|||Count of Participants
2571424|NCT02516982|Primary|Number of Participants According to Their Score on Question 10 of the EPDS According to Survey Layout|Number of participants scoring 1 point or more on question 10 of the Edinburgh Postnatal Depression Scale, which deals with thoughts of self-harm. This outcome was only measured in the Screening - Scrolling layout and in the Screening - Paging layout groups.|One-off assessment immediately after recruitment||||Participants|||Count of Participants
2571425|NCT02516982|Primary|Number of Participants at Each EPDS Scoring Interval According to Survey Layout|Number of participants scoring at each of the scoring intervals that have been reported for the Edinburgh Postnatal Depression Scale: 0 to 9 points - low risk; 10 to 12 points - moderate risk; 13 points or more - high risk. This outcome was only measured in the Screening - Scrolling layout and in the Screening - Paging layout groups.|One-off assessment immediately after recruitment||||Participants|||Count of Participants
2571426|NCT02516982|Primary|Median EPDS Scores According to Survey Layout|This outcome was only measured in the Screening - Scrolling layout and in the Screening - Paging layout groups. Median scores on the Edinburgh Postnatal Depression Scale according to group allocation. The EPDS consists of 10 questions each rated on a 4-point scale ranging from 0 to 3 points. Overall scores are obtained by adding the scores of all the individual questions, and range from 0 points to 30 points. Overall scores of 0 to 9 points suggest a low risk of perinatal depression. Overall scores between 10 and 12 points suggest an increased risk of perinatal depression. Overall scores of 13 points or more suggest that the respondent is likely to have met the diagnostic criteria for perinatal depression. Moreover, scores of 1 point or more on question 10 of the EPDS ought to be explored further as this question deals with ideas of self-harm.|One-off assessment immediately after recruitment||||Score on a scale||Full Range|Median
2571427|NCT02516982|Primary|Number of Participants Responding Affirmatively to at Least One Whooley Question According to Survey Layout|Comparison of the number of participants answering affirmatively to at least one Whooley question in each experimental group. This outcome was only measured in the Screening - Scrolling layout and in the Screening - Paging layout groups.|One-off assessment immediately after recruitment||||Participants|||Count of Participants
2571428|NCT02516605|Secondary|Change From Baseline in Global Itch Visual Analogue Scale (VAS)|Baseline is defined as the latest available predose value. The Global Itch Visual Analogue Scale, a 100 mm visual analogue scale (VAS), was used to assess the severity of patients itch (ranging from 0 = none at all to 100 = the worst imaginable itch). The score range is between a minimum of 0 and a maximum of 100. The score (distance in mm from left) on the VAS was recorded by the patient marking with a line and used to test for an effect of tropifexor over placebo. The mean change from baseline in itch VAS score in each treatment group is presented.|Day 7, Day 14, Day 21, Day 28, Day 56, and Day 84|The PD analysis set included all subjects with any available PD data and no protocol deviations with relevant impact on PD data.|||mm||90% Confidence Interval|Mean
2571444|NCT02516592|Secondary|Transitional Dyspnea Index (TDI) Focal Score|Transition Dyspnea Index (TDI) is an instrument used to assess a participant's level of dyspnea. The TDI focal score have three domains: functional impairment, magnitude of task and magnitude of effort. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.|Baseline, week 12|The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to.|||Score on a scale||Standard Error|Least Squares Mean
2571429|NCT02516605|Secondary|Change From Baseline in Itch Subdomain of PBC-40 Score|Baseline is defined as the latest available predose value. The PBC-40 is a paper-based, patient-derived, disease-specific health-related quality of life (HRQOL) patient reported outcome (PRO) measure which was developed and validated for use in PBC patients (Jacoby et al 2005). It consists of 40 questions arranged in 6 domains with between 3 and 11 questions in each domain. Each question is scored from 1 to 5 in increasing order of severity. This dataset focuses on the itch subdomain which consists of 3 questions. These 3 questions within the itch subdomain are summed to obtain a total score for the itch subdomain. The total score range is between a minimum of 3 and a maximum of 15. Higher scores represent a poorer quality of life. The median change from baseline in total itch subdomain score in each treatment group is presented.|Baseline, Day 28, Day 56, Day 84|The PD analysis set included all subjects with any available PD data and no protocol deviations with relevant impact on PD data.|||UNITS ON A SCALE||Full Range|Median
2571430|NCT02516605|Secondary|Changes From Baseline in Total PBC-40 Score|Baseline is defined as the latest available predose value. The PBC-40 is a paper-based, patient-derived, disease-specific health-related quality of life (HRQOL) patient reported outcome (PRO) measure which was developed and validated for use in PBC patients (Jacoby et al 2005). It consists of 40 questions arranged in 6 domains with between 3 and 11 questions in each domain. Each question is scored from 1 to 5 in increasing order of severity. All questions within a domain are summed and all domain totals are summed to obtain a total score. The total score range is between a minimum of 40 and a maximum of 200. Higher scores represent a poorer quality of life. The median difference from baseline in total sum score for each treatment group is presented.|Baseline, Day 28, Day 56, Day 84|The PD analysis set included all subjects with any available PD data and no protocol deviations with relevant impact on PD data.|||units on a scale||Full Range|Median
2571431|NCT02516605|Secondary|Plasma PK Parameter - Tmax|Tropifexor levels were determined in plasma using a validated LC-MS/MS method. Tmax = The time to reach the maximum concentration after drug administration [time]|Day 1, Day 28|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||hr||Inter-Quartile Range|Median
2571432|NCT02516605|Secondary|Plasma PK Parameter - Cmax|Tropifexor levels were determined in plasma using a validated LC-MS/MS method. Cmax=The observed maximum plasma concentration following drug administration [mass /volume]|Day 1, Day 28|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||ng/mL||Standard Deviation|Mean
2571433|NCT02516605|Secondary|Plasma PK Parameter - AUC 0-8h|Tropifexor levels were determined in plasma using a validated LC-MS/MS method. AUC0-t=The area under the plasma concentration-time curve from time zero to time 't' where t is a defined time point after administration [mass x time / volume]|Day 1, Day 28|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||hr*ng/mL||Standard Deviation|Mean
2571434|NCT02516605|Primary|Haemoglobin|Hematology panel for safety laboratory assessments.|Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84|Safety Analysis Set|||g/L||Standard Deviation|Mean
2571435|NCT02516605|Primary|ECG Intervals - PR Interval|Electrocardiogram (ECG)|Screening, Baseline, day 1, day 28|Safety Analysis Set|||msec||Standard Deviation|Mean
2571436|NCT02516605|Primary|ECG - Heart Rate|Electrocardiogram (ECG)|Screening, Baseline, day 1, day 28|Safety Analysis Set|||bpm||Standard Deviation|Mean
2571437|NCT02516605|Primary|Body Temperature|Vital signs|Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84|Safety Analysis Set|||Celsius||Standard Deviation|Mean
2571438|NCT02516605|Primary|Pulse Rate|Vital signs|Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84|Safety Analysis Set|||bpm||Standard Deviation|Mean
2571439|NCT02516605|Primary|Blood Pressure|Vital signs - Systolic Blood pressure|Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84|Safety Analysis Set|||mm Hg||Standard Deviation|Mean
2571440|NCT02516605|Primary|Fold Change in Serum Gamma-glutamyl Transferase (GGT)|Fold change in serum gamma-glutamyl transferase (GGT) from baseline to Day 28|Baseline to Day 28|The PD analysis set included all subjects with any available PD data and no protocol deviations with relevant impact on PD data.|||fold-change||90% Confidence Interval|Mean
2571441|NCT02516592|Secondary|Change From Baseline in Mean Daily Use of Rescue Medication|Use of rescue medication (number of puffs taken in the previous 12 hours) is recorded morning and evening, by the patient, in a paper diary. A negative change from baseline indicates an improvement.|over 12 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to|||Number of puffs||Standard Error|Least Squares Mean
2571442|NCT02516592|Secondary|Change From Baseline in Total Symptom Score- CAT (COPD Assessment Test)|The participants will record their COPD symptoms in this test before every clinic visit, this will include : cough, phlegm, chest tightness, breathlessness, limitation in activities, energy, soundly sleep, etc. A higher score indicates a worse health status. The result is immediately available without the need for any calculation, apart from summing the scores on individual items. Scores of 0 - 10 represent mild, 11 - 20 represent moderate, 21 - 30 represent severe and 31 - 40 represent very severe clinical impact of COPD upon the patient.|week 12|The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to|||Score on a scale||Standard Error|Least Squares Mean
2571443|NCT02516592|Secondary|Change From Baseline in FVC (Forced Vital Capacity)|Pulmonary function assessments were performed using centralized spirometry according to international standards. FVC wil follow the same analysis as for FEV1|week 12|The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to|||Liters||Standard Error|Least Squares Mean
2571458|NCT02516410|Secondary|Number of Pulmonary Exacerbation Events|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. The number of events were reported.|Baseline through Week 12|FAS included all randomized participants who received at least 1 dose of study drug.|||Pulmonary exacerbation events|||Number
2572954|NCT02500537|Secondary|Staple Line Assessment: Incidence of Leakage|As measured by air leak test, or standard of care, as applicable|Day 0||||incidences of leakage|||Number
2571445|NCT02516592|Primary|Change From Baseline in Trough Pre-dose FEV1 in Both Arms|Pulmonary function assessments were performed using centralized spirometry according to international standards. Mean trough pre-dose FEV1 at Week 12 is defined as the average of the measurements taken -45min and -15min pre study medication dose in the clinic after 12 weeks of treatment (Day 84). The baseline measurement is defined as the average of the scheduled FEV1 values prior to first intake of randomized study drug at Day 1 (Visit 2).|Baseline, week 12|The full analysis set (FAS) included all randomized patients who received at least one dose of randomized study medication; patients were analyzed according to the treatment they were randomized to|||Liters||Standard Error|Least Squares Mean
2571446|NCT02516579|Primary|% of Patient-years With Myelosuppressions|Patients with at least one myelosuppression|During the follow-up of participant, up to 10 years||||% patient-years|||Number
2571447|NCT02516579|Primary|% of Patient-years With Skin Ulcerations|Patients with at least one skin ulceration|During the follow-up of participant, up to 10 years||||% patient-years|||Number
2571448|NCT02516579|Primary|% of Patient-years With Malignancies||During the follow-up of participant, up to 10 years|Patients with follow-up visit|||% patient-years|||Number
2571449|NCT02516410|Secondary|Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolite (M1 VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)|This outcome was not planned to be assessed in Placebo arm.|Pre-morning dose on Week 2, Week 4, Week 8 and Week 12|Pharmacokinetic (PK) set included all randomized participants who received any amount of study drug and had a PK assessment. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2571450|NCT02516410|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or newly developed at or after initial dosing of study drug to Week 16 was considered treatment-emergent.|Baseline up to Week 16|Safety Set included all participants who received at least 1 dose of the study drug.|||Participants|||Number
2571451|NCT02516410|Secondary|Absolute Change From Baseline in Body Weight at Week 12||Baseline, Week 12|FAS included all randomized participants who received at least 1 dose of study drug. Here 'Number of participants analysed' signifies those participants who were evaluable for this outcome measure.|||Kilograms (kg)||95% Confidence Interval|Least Squares Mean
2571452|NCT02516410|Secondary|Absolute Change From Baseline in BMI Z-score at Week 12 (in Participants Less Than [<] 20 Years Old at the Time of Screening)|Z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is, with range from infinity to +infinity; where 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. BMI, adjusted for age and sex, was analyzed as BMI-for-age Z-score (BMI z-score). BMI-for-age z-score was calculated by using centers for disease control and prevention (CDC) growth charts for the paediatric population.|Baseline, Week 12|Analysis population included all randomized participants who received at least 1 dose of study drug and were <20 years of age at the time of screening.|||Z-score||95% Confidence Interval|Least Squares Mean
2571453|NCT02516410|Secondary|Number of Participants With at Least One Pulmonary Exacerbation Through Week 12|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. Time-to-first pulmonary exacerbation was planned to be estimated using Kaplan-Meier (KM) estimates. However, due to less than 50% of events, time-to-first event data was not estimated. Instead, number of participants with at least one pulmonary exacerbation event were collected and are reported.|Baseline through Week 12|FAS included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2571454|NCT02516410|Secondary|Absolute Change From Baseline in Sweat Chloride Through Week 12|Sweat samples were collected using an approved collection device.|Baseline, Through Week 12|FAS included all randomized participants who received at least 1 dose of study drug. Here 'Number of participants analysed' signifies those participants who were evaluable for this outcome measure.|||Millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2571455|NCT02516410|Secondary|Relative Change From Baseline in Percent Predicted FEV1 Through Week 12|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years.|Baseline, Through Week 12|FAS included all randomized participants who received at least 1 dose of study drug. Here 'Number of participants analysed' signifies those participants who were evaluable for this outcome measure.|||Percent Change||95% Confidence Interval|Least Squares Mean
2571456|NCT02516410|Secondary|Absolute Change From Baseline in Body Mass Index (BMI) at Week 12|BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).|Baseline, Week 12|FAS included all randomized participants who received at least 1 dose of study drug. Here 'Number of participants analysed' signifies those participants who were evaluable for this outcome measure.|||Kg/m^2||95% Confidence Interval|Least Squares Mean
2571457|NCT02516410|Secondary|Number of Pulmonary Exacerbation Events Per Year|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. Total number of days on study is equal to the Week 12 date or the last dose date (whichever occurs last) minus first dose date plus 1. The total number of years (48 weeks) on study is equal to the total number of days on study divided by 336. Pulmonary exacerbation events per year (48 weeks) are reported.|Baseline through Week 12|FAS included all randomized participants who received at least 1 dose of study drug.|||Pulmonary exacerbation events per year|||Number
2571460|NCT02516410|Primary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 12|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years.|Baseline, Through Week 12|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug. Here 'Number of participants analysed' signifies those participants who were evaluable for this outcome measure.|||Percentage of predicted FEV1||Standard Error|Least Squares Mean
2571461|NCT02516306|Primary|Ocular Comfort Assessment Following Instillation at Baseline and the Day Prior to Each Study Visit|"Ocular comfort was assessed at Baseline (Day 1) and following the last dose on the day prior to each office visit. Comfort was assessed by each subject marking a visual analog scale labeled 0 (Very Comfortable), 5 (Comfortable) and 10 (Very Uncomfortable) immediately following instillation of their assigned study product to one eye (Baseline) or both eyes (Days 8 - 91). A small number indicated better comfort. No formal inferential statistics hypotheses were tested."|Baseline, Day 7, Day 14, Day 30, Day 60, Day 90|Includes all subjects who completed the study: EV06 Ophthalmic Solution (49 of 50) and Placebo Ophthalmic Solution (23 of 25)|||units on a scale||Standard Deviation|Mean
2571462|NCT02516202|Secondary|Vaginal Maturation Index|Objective Measures of Genitourinary Atrophy: Vaginal Maturation Index (VMI) described by % parabasal, intermediate, and superficial cells (≤ 5% or >5% superficial cells) at week 12|Week 12|Sample includes 223 participants with VMI ≤ 5% superficial cells at baseline and non-missing VMI data at week 12|||Participants|||Count of Participants
2571463|NCT02516202|Secondary|pH|Objective measures of genitourinary atrophy: pH (<5 or >5) at week 12|Week 12|Sample includes 247 participants with pH > 5 at baseline and non-missing data on pH at week 12|||Participants|||Count of Participants
2571464|NCT02516202|Secondary|Patient Benefit Evaluation|Patient Benefit Evaluation: Overall, do you believe that you experienced a meaningful benefit from the study medication? (Yes/No).|Week 12||||Participants|||Count of Participants
2571465|NCT02516202|Secondary|Treatment Satisfaction|Likert Scale 0 = no to 10 = complete satisfaction.|Week 12||||units on a scale||Standard Deviation|Mean
2571466|NCT02516202|Secondary|Female Sexual Function Index|Female Sexual Function Index (FSFI); Evaluate dyspareunia, sexual function and distress. A composite score from 2 (not sexually active and no desire) to 36 and 6 domains.|Baseline, Week 4, Week 12||||units on a scale||95% Confidence Interval|Mean
2571467|NCT02516202|Secondary|Vaginal Symptoms Index|"Mean change from baseline to 12 weeks in composite Vaginal Symptoms Index (VSI).~The VSI is a Modified Bachman scale measuring vulvovaginal itching, dryness, irritation, soreness, and pain with sexual activity among sexually active women, each rated 0=none to 3=severe, and then averaged for a total score of 0-3."|Baseline, Week 4, Week 12|Analysis includes participants with VSI data at baseline and either week 4 or 12.|||units on a scale||95% Confidence Interval|Mean
2571468|NCT02516202|Primary|Most Bothersome Symptom (MBS) Severity|Mean change from baseline to 12 weeks in the severity of the MBS on a scale of 0-3, better to worse.|Baseline, Week 4, Week 12|Analysis includes participants with MBS data at baseline and either week 4 or 12.|||units on a scale||95% Confidence Interval|Mean
2571469|NCT02516163|Primary|Repeatability of Cutting Guide Position|Repeatability of cutting guide position on the distal femur and proximal tibia assessed by repeated measures using computer navigation system for total knee replacement, assessed intra-operatively. Placement of the cutting guides by the surgeon was determined by recording the position of the cutting guide when placed by the same surgeon multiple times. The intraclass correlation coefficient (ICC) was calculated for each positioning parameter. This included femoral and tibial varus/valgus,flexion/extension, medial resection, lateral resection and rotation. ICC agreement categories:>0.75 excellent agreement; 0.75-0.4 good or fair agreement; <0.4 poor agreement.|Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.||||intraclass correlation coefficient (ICC)|Participants|95% Confidence Interval|Number
2571470|NCT02516150|Secondary|Maximum Change in GIR (Glucose Infusion Rate) From Baseline|This outcome is measuring the maximum change in the glucose infusion rate from the GIR at the time of the injection through the 90 minutes after the glucagon injection in the presence and absence of ethanol. The glucose infusion rate is adjusted up to every two minutes throughout the clamp, and for 90 minutes total after the glucagon injection.|1 Day Visit (approximately 8 to 11 hours)||||ml/hour||Standard Deviation|Mean
2571471|NCT02516150|Primary|AOCGIR (Area Over the Curve for Glucose Infusion Rate)|Area over the curve for the glucose infusion rate in the hour following a subcutaneous glucagon dose with a blood alcohol content of 0 vs 0.1%|1 Day Visit (approximately 8 to 11 hours)||||mg*minute/dl||Standard Deviation|Mean
2571472|NCT02516098|Secondary|Area Under the Curve, for the Test Product, to the Time of the Maximum Concentration of the Reference Product and the Test Product (AUCReftmax)|Area under the concentration-time curve of hyoscine butylbromide to the time of the maximum concentration of hyoscine butylbromide of the reference product (Buscopan®). This was calculated both for test and reference products.|Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter|PK population|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2571473|NCT02516098|Secondary|Area Under the Plasma Concentration Versus Time Curve, With Extrapolation to Infinity (AUC0-∞).|The area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).|Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter|PK population|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2571474|NCT02516098|Primary|AUC Time Zero to Times of Last Quantifiable Concentration (AUC 0-t)|Area under the concentration-time curve of hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point (AUC0-t).|Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter|PK population|||hour (h)*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2571475|NCT02516098|Primary|Maximum Observed Plasma Concentration of Hyoscine Butylbromide (Cmax)|The maximum measured concentration of hyoscine butylbromide in plasma.|Blood sampling within 2 hours prior to dosing, and 30, 60, and 120 minutes, and at 2.5, 3, 3.5, 3.75, 4, 4.25, 4.5, 5, 5.5, 6, 8, 12, 24, 36, 48 and 60 hours thereafter|All subjects who had evaluable pharmacokinetic (PK) data for at least one of the treatment periods were included in the PK population.|||picogram (pg)/millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
2571476|NCT02515994|Secondary|Average Wear Time|Average Wear time was recorded for each subject at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks. The average wear time across all visits was reported.|3 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Hours per day||Standard Deviation|Mean
2571477|NCT02515994|Secondary|Symptoms|"Ocular symptoms, problems and complaints were assessed by a questionnaire at each visit 1-, 2-, 3-, 4-, 8- and 12- week follow-ups. The number of events where subjects that responded 'yes' to the item Experienced Eye Symptoms or Problems? were reported."|Up to 3 month Follow-up|All subjects that were dispensed a study lens.|||Eyes|Participants||Number
2571478|NCT02515994|Primary|Visual Acuity|Monocular best-corrected visual acuity was assessed using a Snellen (ETDRS) on a LogMAR scale at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks for each subject and subject eye. LogMAR visual acuity was evaluated under high luminance high contrast condition. The average visual acuity across all visits was reported.|Up to 3 month Follow-up|Subjects that completed all study visits without a major protocol deviation.|||LogMAR|Participants|Standard Deviation|Mean
2571479|NCT02515994|Primary|Slit Lamp Findings|Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by eye was reported.|Up to 3 Month Follow-up|All subjects that were dispensed a study lens.|||Eyes|Participants||Number
2571480|NCT02515942|Secondary|Percentage of Subjects With Anti-LFG316 Antibodies up to Day 421|Samples were collected and assessed for anti-LFG316 antibodies.|Baseline (Day 1), up to Day 421|IG analysis set: All subjects in the safety analysis set with evaluable immunogenicity (IG) data and with no major protocol deviations that had an impact on the assessment of immunogenicity.|||percentage of subjects|||Number
2571481|NCT02515942|Secondary|Percentage of Subjects With Anti-CLG561 Antibodies up to Day 421|Samples were collected and assessed for anti-CLG561 antibodies.|Baseline (Day 1), up to Day 421|IG analysis set: All subjects in the safety analysis set with evaluable immunogenicity (IG) data and with no major protocol deviations that had an impact on the assessment of immunogenicity.|||percentage of subjects|||Number
2571482|NCT02515942|Secondary|Total LFG316 Serum Concentration up to Day 421|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.|Baseline (Day 1), Day 337, Day 421|PK Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included.|||ng/mL||Standard Deviation|Mean
2571483|NCT02515942|Secondary|Total CLG561 Serum Concentrations up to Day 421|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.|Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 85, Day 169, Day 253, Day 309, Day 337, Day 421|PK Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included.|||ng/mL||Standard Deviation|Mean
2571484|NCT02515942|Secondary|Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS|BCVA was assessed using ETDRS testing at 4 meters. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment and is reported categorically. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.|Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 30, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337|FAS. At each time point, only subjects with a value at both baseline and that time point are included.|||percentage of subjects|||Number
2571485|NCT02515942|Secondary|Average LLVA Deficit (Letters) Change From Baseline at Day 281 to Day 337 as Measured by ETDRS|LLVA was assessed at 4 meters using a neutral density filter to reduce chart luminance to 3 candelas/m2. A deficit in LLVA is defined as a loss in letters read from baseline. Baseline is defined as the last measurement prior to first dose of treatment. Day 281, Day 309, and Day 337 were averaged and compared to baseline. A negative change value indicates improvement (more letters read). One eye (study eye) contributed to the analysis.|Baseline (Day 1), Day 281, Day 309, Day 337|PPS. At each time point, only subjects with a value at both baseline and that time point are included.|||letters||Standard Deviation|Mean
2571486|NCT02515942|Secondary|Average Change in LLVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS|LLVA was assessed at 4 meters using a neutral density filter to reduce chart luminance to 3 candelas/m2. Baseline is defined as the last measurement prior to first dose of treatment. Day 281, Day 309, and Day 337 were averaged and compared to baseline. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.|Baseline (Day 1), Day 281, Day 309, Day 337|PPS. At each time point, only subjects with a value at both baseline and that time point are included.|||letters||Standard Deviation|Mean
2571487|NCT02515942|Secondary|Average Change in BCVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS|BCVA was assessed using ETDRS testing at 4 meters. Day 281, Day 309, and Day 337 were averaged and compared to baseline. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.|Baseline (Day 1), Day 281, Day 309, Day 337|PPS. At each time point, only subjects with a value at both baseline and that time point are included.|||letters||Standard Deviation|Mean
2571538|NCT02515045|Secondary|Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)|Intraocular pressure refers to the pressure inside the eye. It is measured in mmHg using a device called a tonometer. The mean IOP is 15.5 mmHg. Raised IOP after cataract surgery is common and in most cases it is transient and benign.|Month 1.||||mmHg||Standard Deviation|Mean
2571488|NCT02515942|Secondary|Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS|Low Luminance Visual Acuity (VA) was assessed using ETDRS testing at 4 meters with a neutral density filter to reduce chart luminance to 3 candelas/m2. A deficit in LLVA is defined as a loss in letters read from baseline. Baseline is defined as the last measurement prior to first dose of treatment. A negative change value indicates improvement (more letters read). One eye (study eye) contributed to the analysis.|Baseline (Day 1), Day 2, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337|FAS. At each time point, only subjects with a value at both baseline and that time point are included.|||letters||80% Confidence Interval|Least Squares Mean
2571489|NCT02515942|Secondary|Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS|Low Luminance Visual Acuity (VA) was assessed using ETDRS testing at 4 meters with a neutral density filter to reduce chart luminance to 3 candelas/m2. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis.|Baseline (Day 1), Day 2, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337|FAS. At each time point, only subjects with a value at both baseline and that time point are included.|||letters||80% Confidence Interval|Least Squares Mean
2571490|NCT02515942|Secondary|Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS)|BCVA was assessed using ETDRS testing at 4 meters. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis.|Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 30, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337|FAS. At each time point, only subjects with a value at both baseline and that time point are included.|||letters||80% Confidence Interval|Least Squares Mean
2571491|NCT02515942|Secondary|Mean Change in GA Lesion Size From Baseline to Day 421 as Measured by FAF|Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis. Day 421 measurements were only summarized descriptively and did not include any statistical modeling.|Baseline (Day 1), Day 421|PPS. At each time point, only subjects with a value at both baseline and that time point are included.|||mm2||Standard Deviation|Mean
2571492|NCT02515942|Secondary|Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF|Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis.|Baseline (Day 1), Day 85, Day 169, Day 253|PPS. At each time point, only subjects with a value at both baseline and that time point are included.|||mm2||80% Confidence Interval|Least Squares Mean
2571493|NCT02515942|Primary|Change in GA Lesion Size From Baseline to Day 337 as Measured by Fundus Autofluorescence (FAF)|Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis.|Baseline (Day 1), Day 337|PPS. Only subjects with a value at both baseline and that time point are included.|||square millimeters (mm2)||80% Confidence Interval|Least Squares Mean
2571494|NCT02515942|Primary|Mean Change From Baseline in Intraocular Pressure (IOP)|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry and reported in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline is defined as the last measurement prior to first dose of treatment. A more negative change indicates a greater amount of improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.|Baseline (Day 1), Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309|Safety Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included.|||mmHg||Standard Deviation|Mean
2571495|NCT02515942|Primary|Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug|A serious adverse event (SAE) was defined as any adverse experience that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All SAEs related to the study drug are reported. No statistical analysis was conducted.|Up to Day 421|Safety Analysis Set|||subjects|||Number
2571496|NCT02515851|Secondary|Over Satisfaction|Patients will rate satisfaction with their surgery and recovery on a 1 to 10 scale with 1 being the lest and 10 being the most satisfied.|7 days after surgery|Data were not collected||||||
2571497|NCT02515851|Secondary|Passive Wrist Range of Motion|Wrist range of motion possible when surgeon moves the wrist between 0 and 180 degrees.|7 days after surgery|Data were not collected||||||
2571498|NCT02515851|Secondary|Total Narcotic Pain Medication Usage|The total narcotic pain medication usage for 1 week after surgery|7 days after surgery|Data were not collected||||||
2571499|NCT02515851|Primary|Pain Medication Usage|the amount of pain medication used in the three days following surgery.|three days|Data were not collected||||||
2571539|NCT02515045|Secondary|Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)|"Cornea is the clear part of the front of the eye. Normal corneal thickness is in average 0.540 mm. The corneal thickness is measured with a handheld device called pachymeter.~An increase in corneal thickness may indicate corneal edema (swelling of the cornea) that could be seen after ocular surgery."|Month 1||||Microns||Standard Deviation|Mean
2571500|NCT02515669|Secondary|Change From Baseline in Thigh Muscle Maximal Cross Sectional Area (CSAmax)|"Right thigh measurements. W12 = Week 12, W24 = Week 24.~Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361."|Baseline through Week 24|The pharmacodynamics (PD) data set includes all available data from subjects for whom PD measurements are available at baseline and at least one other timepoint.|||Percentage Change||Standard Error|Mean
2571501|NCT02515669|Secondary|Fold Change From Baseline in Contractile Versus Non-contractile Content for Muscles in the Right Thigh|"Ratio of Contractile vs Non-contractile Content is Contractile Content / Non-contractile Content. Fold change from Baseline of the ratio is defined as the ratio of Fold change from baseline of Contractile content vs Fold change from baseline of Non-contractile content.~Right thigh measurements. W12 = Week 12, W24 = Week 24.~Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361."|Baseline through Week 24|The pharmacodynamics (PD) data set includes all available data from subjects for whom PD measurements are available at baseline and at least one other timepoint.|||Fold Change||Standard Error|Mean
2571502|NCT02515669|Secondary|Serum Concentration of Drug-myostatin Complex|Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.|Baseline through week 24|The pharmacodynamics (PD) data set includes all available data from subjects for whom PD measurements are available at baseline and at least one other timepoint.|||ng/mL||Standard Deviation|Mean
2571503|NCT02515669|Secondary|Percent Inhibition of Free Myostatin|Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.|Baseline through week 24|The pharmacodynamics (PD) data set includes all available data from subjects for whom PD measurements are available at baseline and at least one other timepoint.|||Percent||Standard Deviation|Mean
2571504|NCT02515669|Secondary|Serum Concentration of Free Myostatin in the Double-blind Phase|Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361.|Baseline through week 24|The pharmacodynamics (PD) data set includes all available data from subjects for whom PD measurements are available at baseline and at least one other timepoint.|||pg/mL||Standard Deviation|Mean
2571505|NCT02515669|Secondary|Frequency of Subjects With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Whole Study|"A positive ADA sample is defined as one in which the presence of detectable ADAs is confirmed to be specific to RO7239361. A participant is considered as ADA positive if, after initiation of treatment, they have an ADA positive relative to baseline sample.~Double-blind phase data for placebo participants is not included. Placebo participants in each arm moved on to RO7239361 upon entering the open label phase.~Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361."|Day 8 through Week 72, baseline and on-study information represented in table.||||Percentage of Participants|||Number
2571506|NCT02515669|Secondary|Frequency of Subjects With Positive Anti-RO7239361 Antibodies (ADA) Assessment, Double-Blind Phase|"A positive ADA sample is defined as one in which the presence of detectable ADAs is confirmed to be specific to RO7239361. A participant is considered as ADA positive if, after initiation of treatment, they have an ADA positive relative to baseline sample.~Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361."|Day 8 through Week 24, baseline and on-study information represented in table.||||Percentage of Participants|||Number
2571507|NCT02515669|Secondary|RO7239361 Trough Concentrations|"Trough concentrations of RO7239361 at different dose levels.~Panel 1 = 4mg, Panel 2 = 12.5mg and 20mg, Panel 3 = 35mg, Expansion Panels = 35mg and 50mg.~Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361."|Baseline to Week 24|Pharmacokinetic population. Where the number of participants analyzed is 0 for the Panel 2 20mg dose, it is due to that dose not being administered at that visit.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2571508|NCT02515669|Secondary|Area Under the Concentration-Time Curve From Time Zero to Time of Next Dosing (AUCtau) of RO7239361 at Steady State for 50 mg QW Dose.|"PK parameter estimates at steady state following approximately 12 weeks QW administration.~Panel 3 = 50 mg QW~Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361."|Baseline to Week 24||||ng•day/mL||Geometric Coefficient of Variation|Geometric Mean
2571509|NCT02515669|Secondary|Area Under the Concentration-Time Curve From Time Zero to Time of Next Dosing (AUCtau) of RO7239361 at Steady State for 4 mg QW, 12.5 mg QW and 35 mg QW Doses.|"PK parameter estimates at steady state. Steady state was achieved following approximately 12 weeks QW administration.~Panel: 1 = 4mg QW, 2 = 12.5mg QW, 3 = 35mg QW~Results for the Panel 3 50mg QW dose level are represented in Outcome Measure 8. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361."|Baseline to Week 24||||ng•day/mL||Geometric Coefficient of Variation|Geometric Mean
2571510|NCT02515669|Secondary|Time of Maximum Observed Serum Concentrations (Tmax) of RO7239361 at Steady State for 50 mg QW Dose.|"PK parameter estimates at steady state following approximately 12 weeks QW administration.~Panel 3 = 50 mg QW~Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361."|Baseline to Week 24||||hour||Full Range|Median
2571511|NCT02515669|Secondary|Time of Maximum Observed Serum Concentrations (Tmax) of RO7239361 at Steady State for 4 mg QW, 12.5 mg QW and 35 mg QW Doses.|"PK parameter estimates at steady state. Steady state was achieved following approximately 12 weeks QW administration.~Panel: 1 = 4mg QW, 2 = 12.5mg QW, 3 = 35mg QW.~Results for the Panel 3 50mg QW dose level are represented in Outcome Measure 6. Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361."|Baseline to Week 24||||hour||Full Range|Median
2571512|NCT02515669|Secondary|Maximum Observed Serum Concentrations (Cmax) of RO7239361 at Steady State for 50 mg QW Dose.|"PK parameter estimates at steady state following approximately 12 weeks QW administration.~Panel 3 = 50 mg QW~Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361."|Baseline to Week 24||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2571513|NCT02515669|Secondary|Maximum Observed Serum Concentrations (Cmax) of RO7239361 at Steady State for 4 mg QW, 12.5 mg QW and 35 mg QW Doses.|"PK parameter estimates at steady state. Steady state was achieved following approximately 12 weeks QW administration.~Panel: 1 = 4mg QW, 2 = 12.5mg QW, 3 = 35mg QW~Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361. No participants received the Panel 2 20mg dose."|Baseline to Week 24||||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2571514|NCT02515669|Primary|Safety Summary for the Whole Study|"Percentage of participants with fatalities, adverse event (AEs) and serious adverse events (SAEs) for the whole study.~Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361."|Baseline to 72 weeks||||Percent of Participants|||Number
2571515|NCT02515669|Primary|Safety Summary for the 24 Week Double-Blind Phase|"Percentage of participants with fatalities, adverse event (AEs) and serious adverse events (SAEs) up to Week 24.~Participants in Panel 1 received 4 mg RO7239361; participants in Panel 2 received either 12.5 mg (weight between 15 and 45 kg) or 20 mg (weight >45 kg) RO7239361, and participants in Panel 3 and the Expansion Panel received either 35 mg (weight between 15 and 45 kg) or 50 mg (weight >45 kg) RO7239361."|24 weeks||||Percent of Participants|||Number
2571516|NCT02515656|Secondary|Patient's Global Satisfaction|"The patient filled the satisfaction questionnaire on her patient's diary at home the eve of the End of Treatment Visit.~Six ratings are available: Very Bad, Bad, Somewhat Bad, Somewhat Good, Good and Very Good."|15 days after first administration|There were 10 and 11 missing values respectively in Polygynax and Miconazole + placebo arms.|||Participants|||Count of Participants
2571517|NCT02515656|Secondary|Investigator's Global Satisfaction|"The investigator filled the satisfaction questionnaire during the end of treatment visit.~Six ratings are available: Very Bad, Bad, Somewhat Bad, Somewhat Good, Good and Very Good."|15 days after first administration||||Participants|||Count of Participants
2571518|NCT02515656|Secondary|Clinical Treatment Efficacy (Success/Failure) Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Study Visit|Success and Failure (same definition as the primary outcome measure)|22 days after first treatment administration|There were 5 and 6 missing values respectively in Polygynax and Miconazole + placebo arms.|||Participants|||Count of Participants
2571519|NCT02515656|Secondary|Number of Patients With Change in Vaginal Discharge Assessed by the Investigator|"The vaginal discharge is assessed by the investigator by using a score:~0=absent~mild: insufficient for speculum collection~moderate: sufficient for speculum collection~abundant: visible at the introitus even before speculum introduction."|15 days after first treatment administration||||Participants|||Count of Participants
2571520|NCT02515656|Secondary|Change in Vaginal Discharge and in Each Associated Vaginal Clinical Symptoms Reported by the Patient in the Diary|"This outcome was evaluated using a Visual Analogue Scale (VAS) completed by the patient.~The scale measured the level of each vaginal symptom experienced during the day (vaginal discharge, vaginal burning, vaginal pain and vaginal irritation).~Scale ranges = 0 to 100 0=none symptom 100=maximum intensity of symptom Time points used in the calculation= D1 to D14"|during 14 days after first treatment intake||||mm||95% Confidence Interval|Least Squares Mean
2571521|NCT02515656|Primary|Clinical Treatment Efficacy Assessed by the Investigator After Thorough Gynaecological Examination and Patient's Interview at End of Treatment Visit|"Success is defined by resolution (return to patient's usual gynaecological conditions, i.e. before the episode which warranted inclusion in the study) OR substantial improvement of clinical signs of infectious vaginitis (i.e. abnormal vaginal discharge), and/or vaginal symptoms (vaginal burning and/or vaginal pain, and/or vaginal irritation).~Failure is defined by persistence or worsening of symptoms and clinical signs or requirement of an alternative or specific treatment.~Not considered as Treatment Failure:~The need to initiate a specific treatment because of a Sexually Transmitted Infection (STI) (trichomoniasis; gonococcal and chlamydial infections) detected from the vaginal sample at Visit 1 / D1.~Patients presenting with only vulvar complaints not considered as related to infectious vaginitis."|15 days after first treatment administration||||Participants|||Count of Participants
2571522|NCT02515331|Secondary|Pharmacokinetics of LHW090/LHV527 in Plasma:Tlast|Blood samples were collected to assess Tlast.|Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28|The PK analysis set, which included participants with at least one valid PK concentration measurement and no major protocol deviations affecting PK data, was considered. Only participants with available PK data were analyzed.|||hour||Full Range|Median
2571523|NCT02515331|Secondary|Pharmacokinetics of LHW090/LHV527 in Plasma: Last Measurable Plasma Concentration (Clast)|Blood samples were collected to assess Clast.|Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28|The PK analysis set, which included participants with at least one valid PK concentration measurement and no major protocol deviations affecting PK data, was considered. Only participants with available PK data were analyzed.|||ng/mL||Standard Deviation|Mean
2571524|NCT02515331|Secondary|Pharmacokinetics of LHW090/LHV527 in Plasma: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)|Blood samples were collected to assess AUClast.|Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28|The PK analysis set, which included participants with at least one valid PK concentration measurement and no major protocol deviations affecting PK data, was considered. Only participants with available PK data were analyzed.|||Hr*ng/mL||Standard Deviation|Mean
2571525|NCT02515331|Secondary|Pharmacokinetics of LHW090/LHV527 in Plasma: Time to Reach the Maximum Concentration After Administration of LHW090 (Tmax)|Blood samples were collected to assess Tmax.|Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28|The PK analysis set, which included participants with at least one valid PK concentration measurement and no major protocol deviations affecting PK data, was considered. Only participants with available PK data were analyzed.|||hour||Full Range|Median
2571526|NCT02515331|Secondary|Pharmacokinetics of LHW090/LHV527 in Plasma: Observe Maximum Plasma Concentration Following LHW090 at Steady State in Patients (Cmax)|Blood samples were collected to assess Cmax.|Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs up to 12 hrs on Day 1 and Day 28|The PK analysis set, which included participants with at least one valid PK concentration measurement and no major protocol deviations affecting PK data, was considered. Only participants with available PK data were analyzed.|||ng/mL||Standard Deviation|Mean
2571527|NCT02515331|Primary|Change From Baseline in Mean Daytime Blood Pressure|Change in the 12 hour average of systolic blood pressure (SBP) measured by ambulatory blood pressure was defined as the 12 hour daytime average SBP on Day 28 minus the 12 hour daytime average SBP on Day -1. monitoring (ABPM). A negative change from baseline indicates improvement.|Baseline, day 27|The primary pharmacodynamics (PD) analysis set, which included patients that received study drug with any available PD data, was considered for the analysis. Only patients with values on both baseline and day 27 were analyzed.|||mmHg||Standard Deviation|Mean
2571528|NCT02515331|Primary|Number of Participants With Reported Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths|Number of participants with AEs, SAEs and deaths were assessed.|6 months|Safety analysis set: included all participants who were randomized.|||Participants|||Number
2571529|NCT02515279|Primary|Percentage of Participants With Sustained Virologic Response 24 (SVR24)|Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). SVR24 is defined as the percentage of participants with undetectable HCV RNA 24 weeks after completing treatment.|18 months|All participant who were enrolled in the study. N=number of participants evaluable for this measure.|||percentage of participants|||Number
2571530|NCT02515279|Primary|Percentage of Participants With End of Treatment Response|Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). A participant was considered to have and end of treatment response if there was undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) after completing treatment. Participants with available PCR results were reported.|12 months|All participants who were enrolled in the study. N (Number of participants analysed)=participants who were evaluable for this measure.|||percentage of participants|||Number
2571531|NCT02515279|Primary|Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs.|Up to 6 years|All participants who were enrolled in the study.|||percentage of participants|||Number
2571532|NCT02515253|Primary|Patient Global Impression of Change (PGIC)|Participants will complete the PGIC as part of a questionnaire eight weeks after receiving their treatment for benign breast pain|eight weeks post intervention|"Percentage of those scoring very much improved or much improved"|||percentage|||Number
2571533|NCT02515253|Primary|Patient Global Impression of Change (PGIC)|"Participants will complete the PGIC as part of a questionnaire four weeks after receiving their treatment for benign breast pain~= Very much improved (better outcome)~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse (worse outcome)"|four weeks post intervention|"Percentage of those who scored Very much improved or much improved in each group"|||percentage of VMI/MI respondents|||Number
2571534|NCT02515097|Secondary|Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12|"Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to clear or almost clear at Weeks 2, 4, 6, and 12. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment."|Weeks 2, 4, 6, and 12 (4-week follow-up)|Participants who were randomized and dispensed study drug (ITT population). MCMC multiple imputation was used to impute missing data.|||percentage of participants|||Number
2571535|NCT02515097|Primary|Percentage of Participants With Treatment Success at Week 8|"Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to clear or almost clear at Week 8. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment."|Week 8|Participants who were randomized and dispensed study drug (ITT population). Markov Chain Monte Carlo (MCMC) multiple imputation was used to impute missing data.|||percentage of participants|||Number
2571536|NCT02515058|Secondary|% Residual Graft Material (Histological)|histologic determination of % of residual bone graft material|3 months after ridge preservation||||percentage||Standard Deviation|Mean
2571541|NCT02514889|Secondary|Waist Circumference|The waist circumference was assessed using research standard waist circumference measuring tapes. The result was measured to closest 0.1 cm. The assessor was instructed to position the measuring tape horizontally around the waist, just above the iliac crest.|12 months follow-up|Of 93 participants completing in-person follow-up visit, 1 participant did not undergo waist measurement|||cm||Standard Error|Mean
2571542|NCT02514889|Secondary|Body Mass Index|Body mass index is weight in kilograms divided by the square of the participant's height measured in meters. Wall-mounted stadiometer was used to assess height. Weekly-calibrated, portable, digital scales were used to assess body weight.|12 months follow-up||||kg/m^2||Standard Error|Mean
2571543|NCT02514889|Secondary|Systolic Blood Pressure|Systolic blood pressure assessed on participant's left arm while participant is seated, after at least 5 minutes of rest. Automated, regularly calibrated sphygmomanometer was used with oversize cuffs for obese arms.|12 months follow-up|Participants who completed in-person evaluation at 12 months follow-up|||mm of mercury (equivalent)||Standard Error|Mean
2571544|NCT02514889|Primary|Feeling Full After Last Meal Yesterday|"Take a moment to think about the last meal yesterday. Thinking about the last meal you ate, how full did you feel after that meal? Response was a mark on a 100 mm visual analogue scale (VAS), or oral response to question on a scale from 0 to 100 (for participants assessed via phone), 0=Extremely full and 100=Not at all full. For analysis purposes this measure was reverse-scored, so that higher values represented greater fullness."|12 months follow-up||||units on a scale||Standard Error|Mean
2571545|NCT02514889|Primary|Meal Satisfaction Yesterday|"Take a moment to think about the last meal you ate yesterday. Thinking about the last meal you ate, how satisfied were you after the meal? Response was a mark on a 100 mm visual analogue scale or response to oral question on a scale from 0 to 100 (for participants assessed via phone), with the low end (0) anchored by Very satisfied and the high end (100) anchored by Very unsatisfied. For analysis purposes this measure was reverse-scored, so that higher values represented greater meal satisfaction."|12 months follow-up|Participants who provided survey data at follow-up|||units on a scale||Standard Error|Mean
2571546|NCT02514889|Primary|Medical Outcome Measure = Body Weight|Body weight, measured in kilograms, was obtained by having shoeless participants dressed in light clothing stand on a regularly calibrated medical scale. Measures were taken twice. If these measures differed by more than 0.2 kg, a third measure was taken and averaged with the other two.|12 months follow-up|Participants who completed the in-person follow-up visit for anthropometric evaluation|||kilograms||Standard Error|Mean
2571547|NCT02514889|Primary|Patient-centered Outcome Measure = Self-reported Hunger|"Response to question: Thinking about yesterday, how hungry did you feel during the day? Response was a mark on a 100mm scale or oral response on a scale from 0 to 100 (for participants assessed via phone), 0=Not at all hungry and 100=Extremely hungry."|12 months follow-up||||units on a scale||Standard Error|Mean
2571548|NCT02514772|Primary|Number of Patients Experiencing Potential Infusion-Related Reactions|Patients, experienced infusion related reactions repeatedly (i.e. during the first and second infusion) are counted only once in the overall line.|On the day of and on the day after each study drug infusion (e.g. on study day 1 and 2 for the 1st study drug infusion and on study day 14 and 15 for the 2nd study drug infusion, if the second drug infusion was given on study day 14)|The total number of patients, who received second infusion in GP2013 arm differs from the total number of patients in GP2013 arm due to patients withdrawn after the 1st infusion.|||Participants|||Count of Participants
2571549|NCT02514772|Primary|Immunogenicity|"Number of patients tested positive for anti-drug-antibodies (ADA) post-randomization.~Patients with negative ADA results at screening and at least one evaluable post-randomization ADA assessment are included in the analysis"|24 weeks study duration|Safety Analysis Set|||Participants|||Count of Participants
2571550|NCT02514772|Primary|Number of Patients Experiencing Hypersensitivity Reactions|The standardized MedDRA query (SMQ) - Hypersensitivity reactions (SMQ 20000214) was used for the identification of hypersensitivity reactions overall from first infusion in the adverse event database.|24 weeks study duration|Safety Analysis Set|||Participants|||Count of Participants
2571551|NCT02514772|Primary|Number of Patients Experiencing Anaphylactic Reactions|"2006 NIAID/FAAN* criteria were used for identification of anaphylactic reactions within 24h of each study drug infusion.~For patients with no history of infusion-related reactions during their previous treatments with rituximab, symptoms/signs in at least 2 out of 4 organ systems:~Skin/mucosal tissue~Respiratory organs~Drop of systolic blood pressure (<90 mmHg or variance from baseline >30%) or associated symptoms~Gastrointestinal organs were defined as an anaphylactic reaction.~The same criteria were also applied to patients with history of infusion-related reactions during their previous treatments with rituximab. In addition, if these patients experienced only a rapid drop in systolic blood pressure (<90 mmHg or variance from baseline >30%), this was defined as an anaphylactic reaction disregarding involvement of other organ systems.~* NIAID - National Institute of Allergy and Infectious Diseases FAAN - Food Allergy and Anaphylaxis Network"|Within 24 hours of each study drug infusion: on Day 1 and Day 14|Safety Analysis Set|||Participants|||Count of Participants
2571552|NCT02514577|Secondary|Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12|"Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to clear or almost clear at Weeks 2, 4, 6, and 12. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment."|Weeks 2, 4, 6, and 12 (4-week follow-up)|Participants who were randomized and dispensed study drug (ITT population). MCMC multiple imputation was used to impute missing data.|||percentage of participants|||Number
2571553|NCT02514577|Primary|Percentage of Participants With Treatment Success at Week 8|"Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to clear or almost clear at Week 8. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment."|Week 8|Participants who were randomized and dispensed study drug (ITT population). Markov Chain Monte Carlo (MCMC) multiple imputation was used to impute missing data.|||percentage of participants|||Number
2572955|NCT02500537|Secondary|Staple Line Assessment: Incidence of Staple Line Bleeding|The incidence of staple line bleeding will be measured as ≥ 50 cc|Day 0||||incidences of staple line bleeding|||Number
2571555|NCT02514551|Secondary|Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR) [Disease Control Rate (DCR)]|DCR is defined as the percentage of participants who achieved CR, PR, or SD per RECIST v.1.1. CR is the disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm.Tumor marker results must have normalized. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression. Non-Target PD is unequivocal progression of existing nontarget lesions. DCR=CR+PR+SD/total number of participants*100.|Baseline to Objective Progressive Disease (Up To 21 Months)|All randomized participants.|||percentage of participants|||Number
2571556|NCT02514551|Secondary|Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])|ORR was defined as the percentage of participants who achieved a PR or CR per RECIST v.1.1.CR is the disappearance of all target lesions.Any pathological lymph nodes(whether target or non-target)must have reduction in short axis to<10mm.Tumor marker results must have normalized.PR is at least a 30% decrease in the sum of diameter of target lesions,taking as reference the baseline sum diameters.ORR is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.|Baseline to Objective Progressive Disease (Up To 21 Months)|All randomized participants.|||percentage of participants|||Number
2571557|NCT02514551|Secondary|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination with Paclitaxel|Cycle(C) 1 Day(D) 1: Prior to Infusion(PTI),1 to 1.5 hours(hrs) after end of Infusion(EOI); C1 D15: 3 days PTI; C2 D1: 3 days PTI; C2 D15: 3 days PTI,1 to 1.5 hrs after EOI; C3 D1 and 15: 3 days PTI; C4 D1: 3 days PTI and 1 to 1.5 hrs after EOI|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||Microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2571558|NCT02514551|Secondary|Progression Free Survival (PFS) Ramucirumab 12mg/kg Arm and 8mg/kg Arm in I4T-MC-JVCZ|PFS was defined as time from the date of randomization(RD) to date of radiographic documentation of progression(RDP) or the date of death due to any cause, whichever is earlier as defined by RECIST v.1.1. Participants with no tumor progression and no death were censored at date of last adequate radiological assessment(AST) or date of RD(whichever is later).PD is at least a 20% increase in sum of diameters of target lesions,taking as reference the smallest sum on study.In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression.Non-Target PD is unequivocal progression of existing nontarget lesions.A participant with incomplete baseline disease had PFS time censored at the enrollment date.A participant not known to have died or have RDP as of the data inclusion cutoff date for the analysis had PFS time censored at date of the last complete RDP-free disease AST.|Randomization to Objective Progressive Disease or Death (Up To 21 Months)|All randomized participants. Number of participants censored: Ramucirumab 12 mg/kg + Paclitaxel 80 mg/m2= 25 and 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel =23. All randomized participants (including the censored participants) were included in the analyses.|||months||95% Confidence Interval|Median
2571559|NCT02514551|Primary|Progression Free Survival (PFS) in Ramucirumab 12mg/kg Arm I4T-MC-JVCZ|PFS was defined as time from the date of randomization(RD) to date of radiographic documentation of progression(RDP) or the date of death due to any cause, whichever is earlier as defined by RECIST v.1.1. Participants with no tumor progression and no death were censored at date of last adequate radiological assessment (AST) or date of RD(whichever is later).PD is at least a 20% increase in sum of diameters of target lesions,taking as reference the smallest sum on study.In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression.Non-Target PD is unequivocal progression of existing nontarget lesions.A participant with incomplete baseline disease had PFS time censored at the enrollment date.A participant not known to have died or have RDP as of the data inclusion cutoff date for the analysis had PFS time censored at date of the last complete RDP-free disease AST.|Randomization to Objective Progressive Disease or Death (Up To 21 Months)|All randomized participants in arm 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel. Number of participants censored: Ramucirumab 12 mg/kg + 80 mg/m² Paclitaxel= 25. All randomized participants (including the censored participants) were included in the analyses.|||months||95% Confidence Interval|Median
2571560|NCT02514473|Secondary|Average Pre-dose Concentration (Ctrough,Ave) and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Ave) For Lumacaftor and Ivacaftor|Ctrough,ave is average of individual pre-dose observed concentrations across Week 4 and 24. C3-6h,ave is average of individual 3 to 6 hours post-dose observed concentrations across Day 1, 15 and Week 4. This outcome was not planned to be assessed in Placebo arm.|For Ctrough,ave: before morning dose on Week 4 and 24; For C3-6h,ave: 3 to 6 hours after morning dose on Day 1, 15 and Week 4|Pharmacokinetic (PK) set included all randomized participants who received any amount of study drug and had a PK assessment. Here, 'Number of participants analyzed' = those participants who were evaluable for this endpoint and 'Number Analyzed' = those participants who were evaluable at the specified time points for each arm, respectively.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2571561|NCT02514473|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or newly developed at or after initial dosing of study drug to Week 28 was considered treatment-emergent.|Baseline up to Week 28|Safety Set included all participants who were exposed to any amount of study drug.|||participants|||Number
2571562|NCT02514473|Secondary|Time-to-first Pulmonary Exacerbation|Time-to-first pulmonary exacerbation was analyzed using the Kaplan-Meier estimates. Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.|Baseline through Week 24|FAS.|||Days||Inter-Quartile Range|Median
2571563|NCT02514473|Secondary|Percentage of Participants With At Least 1 Pulmonary Exacerbation Event|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.|Baseline through Week 24|FAS.|||Percentage of participants|||Number
2571564|NCT02514473|Secondary|Number of Pulmonary Exacerbation Events|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. The number of events were reported.|Baseline through Week 24|FAS.|||Pulmonary exacerbation events|||Number
2571565|NCT02514473|Secondary|Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domains Through Week 24|The TSQM is a 14-item self-administered questionnaire which measures participants' experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed to a scale from 0 to 100, where higher scores indicate greater satisfaction.|Baseline, Through Week 24|FAS. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||Units on a scale||Standard Error|Least Squares Mean
2571566|NCT02514473|Secondary|Absolute Change From Baseline in Height-for-age Z-score at Week 24|Z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard. Height, adjusted for age and sex, was analyzed as height-for-age z-score (height z-score). The height-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Z-score||Standard Error|Least Squares Mean
2571567|NCT02514473|Secondary|Absolute Change From Baseline in Height at Week 24||Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Centimeter (cm)||Standard Error|Least Squares Mean
2571568|NCT02514473|Secondary|Absolute Change From Baseline in Weight-for-age Z-score at Week 24|Z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard. Weight, adjusted for age and sex, was analyzed as weight-for-age z-score (weight z-score). The weight-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Z-score||Standard Error|Least Squares Mean
2571569|NCT02514473|Secondary|Absolute Change From Baseline in Weight at Week 24||Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Kg||Standard Error|Least Squares Mean
2571570|NCT02514473|Secondary|Absolute Change From Baseline in BMI-for-age Z-score at Week 24|BMI was defined as weight in kg divided by height in m^2. z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard. BMI, adjusted for age and sex, was analyzed as BMI-for-age z-score (BMI z-score). The BMI-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Z-score||Standard Error|Least Squares Mean
2571571|NCT02514473|Secondary|Relative Change From Baseline in ppFEV1 Through Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Wang standards were used to calculate ppFEV1 (for age, gender, race, and height).|Baseline, Through Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Percent change||Standard Error|Least Squares Mean
2571572|NCT02514473|Secondary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Wang standards were used to calculate ppFEV1 (for age, gender, race, and height).|Baseline, Through Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Percent predicted of FEV1||Standard Error|Least Squares Mean
2571573|NCT02514473|Secondary|Absolute Change From Baseline in Sweat Chloride at Week 24|Sweat samples were collected using an approved collection device.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||mmol/L||Standard Error|Least Squares Mean
2571574|NCT02514473|Secondary|Absolute Change From Baseline in Lung Clearance Index 5.0 (LCI5.0) Through Week 24|LCI is a measure of ventilation inhomogeneity that is derived from a multiple breath washout test using Nitrogen (N2). LCI5.0 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/20th of its starting value.|Baseline, Through Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Ratio||Standard Error|Least Squares Mean
2571575|NCT02514473|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 24|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Through Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Units on a scale||Standard Error|Least Squares Mean
2571576|NCT02514473|Secondary|Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kg divided by height in square meter (m^2).|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Kg/m^2||Standard Error|Least Squares Mean
2571619|NCT02513732|Secondary|Reference Vessel Diameter|Reference vessel diameter measured by QCA|During follow-up, at 8 months post procedure|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mm|Number of lesions QCA|Standard Deviation|Mean
2571577|NCT02514473|Secondary|Average Absolute Change From Baseline in Sweat Chloride at Day 15 and Week 4|Sweat samples were collected using an approved collection device. Baseline was defined as the average of the measurements at screening and on Day 1 pre-dose. Change from Baseline in sweat chloride at Day 15 and Week 4 was calculated. The average of the 2 values (Change at Day 15 and Week 4) was reported.|Baseline, Day 15 and Week 4|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Millimole per liter (mmol/L)||Standard Error|Least Squares Mean
2571578|NCT02514473|Primary|Absolute Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) Through Week 24|Lung clearance index (LCI) is a measure of ventilation inhomogeneity that is derived from a multiple breath washout test using Nitrogen (N2). LCI2.5 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting value.|Baseline, Through Week 24|Full Analysis Set (FAS) included all randomized participants who received any amount of study drug. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Ratio||Standard Error|Least Squares Mean
2571579|NCT02514174|Secondary|Time to First Dose Reduction of Afatinib Caused by Adverse Events|"Time to first dose reduction of afatinib caused by adverse events is defined as time from the date of the first administration of afatinib to the date of first dose reduction of afatinib caused by adverse events. Participants without AEs leading to dose reduction were censored at date of last intake of afatinib.~On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent from study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).~The cumulative probability of no dose reduction at the respective time point is given by the Kaplan-Meier estimate at the respective time point based on time to first dose reduction of afatinib caused by adverse events."|On-treatment period, up to 1057 days|"All participants who received at least one dose of afatinib were included in the treated set. The analyses of safety and efficacy were performed on the treated set.~The 'Number Analyzed' is the 'Number at risk' at the respective time point, that is the number of participants being treated with afatinib 30 mg at the respective time point."|||Probability||95% Confidence Interval|Number
2571580|NCT02514174|Secondary|Percentage of Participants With Adverse Event = Paronychia (Grouped Term) of CTCAE Grade 3 or Higher|"Percentage of participants with adverse event = paronychia (grouped term) of CTCAE grade 3 or higher.~MedDRA preferred terms that described AEs of similar nature were grouped together as grouped term to ensure that important events would not be underestimated.~On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria)."|On-treatment period + 28 days (residual effect period), up to 1057 + 28 days|All participants who received at least one dose of afatinib were included in the treated set. The analyses of safety and efficacy were performed on the treated set.|||Percentage of participants|||Number
2571581|NCT02514174|Secondary|Percentage of Participants With Adverse Event = Stomatitis (Grouped Term) of CTCAE Grade 3 or Higher|"Percentage of participants with adverse event = stomatitis (grouped term) of CTCAE grade 3 or higher.~MedDRA preferred terms that described AEs of similar nature were grouped together as grouped term to ensure that important events would not be underestimated.~On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria)."|On-treatment period + 28 days (residual effect period), up to 1057 + 28 days|All participants who received at least one dose of afatinib were included in the treated set. The analyses of safety and efficacy were performed on the treated set.|||Percentage of participants|||Number
2571582|NCT02514174|Secondary|Percentage of Participants With Adverse Event = Rash/Acne (Grouped Term) of CTCAE Grade 3 or Higher|"Percentage of participants with adverse event = rash/acne (grouped term) of CTCAE grade 3 or higher.~MedDRA preferred terms that described AEs of similar nature were grouped together as grouped term to ensure that important events would not be underestimated.~On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria)."|On-treatment period + 28 days (residual effect period), up to 1057 + 28 days|All participants who received at least one dose of afatinib were included in the treated set. The analyses of safety and efficacy were performed on the treated set.|||Percentage of participants|||Number
2571583|NCT02514174|Secondary|Percentage of Participants With Adverse Event = Diarrhoea of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Higher|"Percentage of participants with adverse event being diarrhoea of CTCAE grade 3 or higher.~On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria)."|On-treatment period + 28 days (residual effect period), up to 1057 + 28 days|All participants who received at least one dose of afatinib were included in the treated set. The analyses of safety and efficacy were performed on the treated set.|||Percentage of participants|||Number
2571584|NCT02514174|Primary|Percentage of Participants Reporting an Adverse Event (AE) Leading to Dose Reduction of Afatinib|On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).|On-treatment period + 28 days (residual effect period), up to 1057 + 28 days|All participants who received at least one dose of afatinib were included in the treated set. The analyses of safety and efficacy were performed on the treated set.|||Percentage||95% Confidence Interval|Number
2571586|NCT02514122|Primary|Postoperative Pain as Measured on a 11-point Numerical Rating Scale|Pain will be measured using an 11-point numerical rating scale from 0 (no pain) to 10 (worst pain imaginable) units on a scale.|The average of twice daily pain scores, from end of surgery until 60 hours postoperative.||||units on a scale||Standard Deviation|Mean
2571587|NCT02514044|Secondary|Percent Change in Blood Pressure|Non-invasive BP measurements performed by a clinician before and after each experiment.|immediately before the treatment, after after the treatment||||percent change in blood pressure||Standard Deviation|Mean
2571588|NCT02514044|Secondary|Boston Diagnostic Aphasia Examination||Baseline,2 months|Data not collected.||||||
2571589|NCT02514044|Secondary|Boston Diagnostic Aphasia Examination||Baseline,2 weeks|Data not collected.||||||
2571590|NCT02514044|Primary|Percent Change in Aphasia Quotient as Assessed by the Western Aphasia Battery|The score on the Aphasia Quotient of the Western Aphasia Battery ranges between 0-100. Higher scores indicate better performance. Below, percent change in the score is reported.|immediately before the treatment, immediately after the treatment||||percent change in aphasia quotient||95% Confidence Interval|Mean
2571591|NCT02514044|Primary|Percent Change in Language Quotient as Assessed by the Western Aphasia Battery|The score on the Language Quotient of the Western Aphasia Battery ranges between 0-100. Higher scores indicate better performance. Below, percent change in the score is reported.|immediately before the treatment, immediately after the treatment||||percent change in language quotient||95% Confidence Interval|Mean
2571592|NCT02513940|Secondary|Number of Participants With Adverse Effects Associated With Testosterone, Progesterone and Placebo|Adverse effects were assessed by study investigators using telephone calls during the 7-day treatment period in each phase, as well as by asking participants about adverse effects on ibutilide administration days|During 7 day administration periods||||Participants|||Count of Participants
2571593|NCT02513940|Secondary|Area Under the QTF Versus Time Curve for 0-1 Hour Following Ibutilide 0.003 mg/kg|"Prolonged QT interval is a marker of increased risk of the ventricular arrhythmia known as torsades de pointes, which can cause sudden cardiac death. Three 12-lead ECGs were obtained ~ 1 minute apart immediately at the end of the ibutilide infusion and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours post-infusion. QT intervals were measured from ECG lead II by one investigator (E.T.M.) who was blinded to the subjects' assigned treatment phases. QT intervals were measured using computerized high-resolution electronic calipers. QT and RR intervals at each time point were averaged over 3 consecutive complexes. The end of the T-wave was determined via the tangent method. Area under the QTF curve was calculated using the trapezoidal rule and reflects overall QTF interval exposure over time."|1 hour following ibutilide administration||||ms·hr||Standard Deviation|Mean
2571594|NCT02513940|Primary|Maximum Percent Change From Pretreatment Value in QTF Following Ibutilide 0.003 mg/kg|QT interval is an ECG measure of ventricular repolarization. Prolonged QT interval is a marker of increased risk of the ventricular arrhythmia known as torsades de pointes, which can cause sudden cardiac death. Three 12-lead ECGs were obtained ~ 1 minute apart immediately at the end of the ibutilide infusion and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours post-infusion. QT intervals were measured from ECG lead II by one investigator (E.T.M.) who was blinded to the subjects' assigned treatment phases. QT intervals were measured using computerized high-resolution electronic calipers. QT and RR intervals at each time point were averaged over 3 consecutive complexes. The end of the T-wave was determined via the tangent method. QT intervals were corrected using the Fridericia (QTF) method.|Within 8 hours of ibutilide administration||||Percent change||Standard Deviation|Mean
2571595|NCT02513940|Primary|Maximum QTF Following Ibutilide 0.003 mg/kg|QT interval is an ECG measure of ventricular repolarization. Prolonged QT interval is a marker of increased risk of the ventricular arrhythmia known as torsades de pointes, which can cause sudden cardiac death. Three 12-lead ECGs were obtained ~ 1 minute apart immediately at the end of the ibutilide infusion and at 5, 10, 15, 20, 30, and 45 minutes and 1, 2, 4, 6, and 8 hours post-infusion. QT intervals were measured from ECG lead II by one investigator (E.T.M.) who was blinded to the subjects' assigned treatment phases. QT intervals were measured using computerized high-resolution electronic calipers. QT and RR intervals at each time point were averaged over 3 consecutive complexes. The end of the T-wave was determined via the tangent method. QT intervals vary with heart rate, and therefore must be corrected for heart rate. QT intervals were corrected using the Fridericia (QTF) method. Maximum QTF is the longest QTF measured following ibutilide at any time point.|Within 8 hours following ibutilide administration||||ms||Standard Deviation|Mean
2571596|NCT02513940|Primary|Baseline (Pre-ibutilide) Individualized Rate-corrected QT Interval (QTF)|QT interval is an electrocardiogram (ECG) measure of ventricular repolarization. Prolonged QT interval is a marker of increased risk of the ventricular arrhythmia known as torsades de pointes, which can cause sudden cardiac death. QT intervals were measured from ECG lead II by one investigator (E.T.M.) who was blinded to the subjects' assigned treatment phases. QT intervals were measured using computerized high-resolution electronic calipers (EP Calipers 1.6). QT and RR intervals at each time point were averaged over 3 consecutive complexes. The end of the T-wave was determined via the tangent method. Only clearly discernable QT intervals were measured. QT intervals vary with heart rate, and therefore must be corrected for heart rate. QT intervals were corrected using the Fridericia (QTF) method. The baseline QTF assesses the influence of testosterone and progesterone on naturally-occurring (before ibutilide administration) QTF|Following 7 days of testosterone, progesterone or placebo||||ms||Standard Deviation|Mean
2571597|NCT02513823|Secondary|Effectiveness of Vitamin d Supplementation on Improving Endothelial Function|Changes of endothelial function at baseline and following 10 weeks of vitamin D supplementation as measured by pulse amplitude tonometry (PAT) fingertip plethysmography. Endothelial dysfunction was classified as a Reactive Hyperemic Index (RHI) of < 1.67 . RHI scale typical ranges from 1.0 to 3.0.|Baseline and 10 weeks||||units on a scale||Standard Deviation|Mean
2571598|NCT02513823|Primary|Effectiveness of Vitamin D Supplementation on Reducing Blood Pressure|Changes in systolic and diastolic blood pressure will be measured at baseline and following vitamin D supplementation for 10 weeks in African American healthy pre-menopausal women|Baseline and 10 weeks||||mmHg||Standard Deviation|Mean
2571599|NCT02513771|Secondary|Number of Participants With Grade ≥2 Adverse Events Related to Study Drug|The DAIDS Adverse Event Grading Table, Version 2.0, was used for grading of AEs|From study entry to end of study (Week 20)|All enrolled participants|||Participants|||Count of Participants
2571600|NCT02513771|Secondary|Change in %CD14dim/CD16++ (Non-classical Monocytes)|"%CD14dim/CD16++ is the percentage of cells that expressed low levels of CD14dim and high levels of CD16++ in total monocytes (also known as non-classical monocytes).~This endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).~Data for cellular markers are not available as of December 2017. These data are based on immunology assays which were tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 1 month after the primary complete date. Please note that these secondary outcomes were not included in the primary analyses. There are many outcomes in this study and the immunology lab had to give priority to the assays planned to be included in the primary manuscript. Results will be entered once the data is complete and analyzed."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||percentage of cells||Inter-Quartile Range|Median
2571601|NCT02513771|Secondary|Change in %CD14+/CD16+ (Intermediate Monocytes)|"%CD14+/CD16+ is the percentage of cells that expressed both CD14 and CD16 in total monocytes (also known as intermediate monocytes).~This endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).~Data for cellular markers are not available as of December 2017. These data are based on immunology assays which were tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 1 month after the primary complete date. Please note that these secondary outcomes were not included in the primary analyses. There are many outcomes in this study and the immunology lab had to give priority to the assays planned to be included in the primary manuscript. Results will be entered once the data is complete and analyzed."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||percentage of cells||Inter-Quartile Range|Median
2571602|NCT02513771|Secondary|Change in %CD14+/CD16- (Classical Monocytes)|"CD14+/CD16- is the percentage of cells that expressed CD14 and low CD16 in total monocytes (also known as classical monocytes).~This endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).~Data for cellular markers are not available as of November 2017. The study team prioritized completion of the soluble markers (including the primary outcome measure), which are reported herein, over the completion of the cellular markers. Results will be entered once the data is complete and analyzed."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||percentage of cells||Inter-Quartile Range|Median
2571603|NCT02513771|Secondary|Change in CD8+ T-cell Activation|"Level of CD8+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+.~The endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).~Data for cellular markers are not available as of December 2017. These data are based on immunology assays which were tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 1 month after the primary complete date. Please note that these secondary outcomes were not included in the primary analyses. There are many outcomes in this study and the immunology lab had to give priority to the assays planned to be included in the primary manuscript. Results will be entered once the data is complete and analyzed."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||percentage of cells||Inter-Quartile Range|Median
2571604|NCT02513771|Secondary|Change in CD4+ T-cell Activation|"Level of CD4+ T-cell activation was determined by measuring the percentage of cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+.~The endpoint is measuring the change from week 0 to week 15 (week 15 - week 0) and change from week 15 to week 20 (week 20 - week 15).~Data for cellular markers are not available as of December 2017. These data are based on immunology assays which were tested in batch to minimize variability. Due to batch testing, shipment of samples for testing could not begin until after the study follow-up completion, which was 1 month after the primary complete date. Please note that these secondary outcomes were not included in the primary analyses. There are many outcomes in this study and the immunology lab had to give priority to the assays planned to be included in the primary manuscript. Results will be entered once the data is complete and analyzed."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||percentage of cells||Inter-Quartile Range|Median
2571605|NCT02513771|Secondary|Change in CD4+/CD8+ T-cell Ratio|CD4+/CD8+ T-cell ratio change from week 0 to week 15 (week 15 - week 0). Note that CD4 and CD8 were not evaluated at week 20 in this study.|Week 0 and week 15|As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||ratio||Inter-Quartile Range|Median
2571606|NCT02513771|Secondary|Change in IP-10|"IP-10 (also known as CXCL10) is a biomarker implicated in cardiovascular disease.~Change in log10 transformed IP-10 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15)."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||log10 pg/mL||Inter-Quartile Range|Median
2571607|NCT02513771|Secondary|Change in sTNF-r2|"sTNF-r2 (soluble tumour necrosis alpha receptor 2) is a biomarker of inflammation.~Change in log10 transformed sTNF-r2 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15)."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||log10 pg/mL||Inter-Quartile Range|Median
2571608|NCT02513771|Secondary|Change in sTNF-r1|"sTNF-r1 (soluble tumour necrosis alpha receptor 1) is a biomarker of inflammation.~Change in log10 transformed sTNF-r1 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15)."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||log10 pg/mL||Inter-Quartile Range|Median
2571609|NCT02513771|Secondary|Change in hsCRP|hsCRP (high-sensitivity C-reactive protein) is a biomarker of inflammation. Change in log10 transformed hsCRP from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15).|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||log10 ng/mL||Inter-Quartile Range|Median
2571610|NCT02513771|Secondary|Change in IL-6|IL-6 (Interleukin-6) is a biomarker of systemic inflammation. Change in log10 transformed IL-6 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15).|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||log10 pg/mL||Inter-Quartile Range|Median
2571611|NCT02513771|Secondary|Change in sCD26|"sCD26 (soluble cluster of differentiation 26) is an enzyme that metabolizes DPP-4 (dipeptidyl peptidase-4), an enzyme that is inhibited by sitagliptin.~Change in log10 transformed sCD26 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15)."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||log10 ng/mL||Inter-Quartile Range|Median
2571612|NCT02513771|Secondary|Change in sCD163|"sCD163 (soluble CD 163) is a marker of macrophage activation and arterial inflammation.~Change in log10 transformed sCD163 from Week 0 to week 15 (week 15 - week 0), and from week 15 to week 20 (week 20 - week 15)."|Week 0, week 15, week 20|As-treated population limited to participants who had baseline and week 15 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||log10 ng/mL||Inter-Quartile Range|Median
2571613|NCT02513771|Secondary|Change in sCD14 From Week 15/16 to Week 20|"sCD14 (soluble cluster of differentiation 14) is a biomarker of gut microbial translocation and monocyte/macrophage activation.~The outcome measures are changes in log10 transformed sCD14 from week 15/16 to week 20 (week 20 - week 15/16).~Levels measured at week 15 and week 16 were averaged for week 15/16."|Week 15, week 16, week 20|As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||log10 pg/mL||Inter-Quartile Range|Median
2571614|NCT02513771|Primary|Change in sCD14 From Baseline to Week 15/16|"sCD14 (soluble cluster of differentiation 14) is a biomarker of gut microbial translocation and monocyte/macrophage activation.~The outcome measures are changes in log10 transformed sCD14 from baseline to week 15/16 (week 15/16 - baseline) Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 15 and week 16 were averaged for week 15/16."|Pre-entry, Week 0, Week 15, Week 16|As-treated population limited to participants who had baseline and week 15/16 measurements, completed study treatment with no more than 34 cumulative days of treatment interruption, did not use prohibited medications, did not have a confirmed virologic failure at or prior to week 16 (see protocol 6.2.3).|||log10 pg/mL||Inter-Quartile Range|Median
2571615|NCT02513745|Secondary|Residual Corneal Astigmatism|This is the anterior corneal astigmatism measured through keratometry. Note that because cataract surgery has been performed, there is no associated baseline value.|Three months|This is a contra-lateral eye study where the first eye undergoing surgery was randomized to conventional or the refractive cataract suite, the fellow eye received the alternate treatment; therefore, we analyzed 78 eyes of 39 participants.|||Diopters||Standard Deviation|Mean
2571616|NCT02513745|Secondary|Residual Mean Spherical Equivalent Refraction|This is the mean of the spherical equivalent refraction (sphere + 0.5*cylinder) from each eye. Note that because cataract surgery has been performed, there is no associated baseline value.|Three months||||Diopters||Standard Deviation|Mean
2571617|NCT02513745|Primary|Residual Refractive Cylinder|This is the manifest refractive cylinder measured 3 months after surgery. Note that because cataract surgery has been performed, there is no associated baseline value.|Three months||||Diopters||Standard Deviation|Mean
2571618|NCT02513732|Secondary|Thrombolysis In Myocardial Infarction (TIMI) Flow|Grade 0: No contrast flow through the stenosis; Grade 1: A small amount of contrast flows through the stenosis but fails to fully opacify the artery beyond; Grade 2: Contrast material flows through the stenosis to opacify the terminal artery segment. However, contrast enters the terminal segment perceptibly more slowly than more proximal segments. Alternatively, contrast material clears from a segment distal to a stenosis noticeably more slowly than from a comparable segment not preceded by a significant stenosis; Grade 3: Anterograde flow into the terminal coronary artery segment through a stenosis is as prompt as anterograde flow into a comparable segment proximal to the stenosis. Contrast material clears as rapidly from the distal segment as from an uninvolved, more proximal segment.|At baseline before procedure||2021-03-31|03/2021||||
2571620|NCT02513732|Secondary|Reference Vessel Diameter|Reference vessel diameter measured by QCA|Immediately after the procedure|ITT population.|||mm|Number of lesions QCA|Standard Deviation|Mean
2571626|NCT02513732|Secondary|Net Gain: In-stent, In-segment|Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain - late loss).|At 8 months, post index procedure|ITT population|||mm|Number of lesions QCA|Standard Deviation|Mean
2571627|NCT02513732|Secondary|Late Loss(LL): In-stent, In-segment, Proximal, and Distal|Late loss is calculated as MLD post procedure - MLD at follow-up.|At 8 months, post index procedure|ITT population|||mm|Number of lesions QCA|Standard Deviation|Mean
2571628|NCT02513732|Secondary|Acute Gain: In-stent, In-segment|The difference between post- and pre-procedural MLD.|At 8 months, post index procedure|ITT population|||mm|Number of lesions QCA|Standard Deviation|Mean
2571629|NCT02513732|Secondary|Number of Participants With Target Lesion Failure (TLF)|TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 5 years|ITT population|||Participants|||Count of Participants
2571630|NCT02513732|Secondary|Number of Participants With Target Lesion Failure (TLF)|TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 4 years|ITT population|||Participants|||Count of Participants
2571631|NCT02513732|Secondary|Number of Participants With Target Lesion Failure (TLF)|TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 3 years|ITT population|||Participants|||Count of Participants
2571632|NCT02513732|Secondary|Number of Participants With Target Lesion Failure (TLF)|TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 2 years|ITT population|||Participants|||Count of Participants
2571633|NCT02513732|Secondary|Number of Participants With Target Lesion Failure (TLF)|TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 1 year|ITT population|||Participants|||Count of Participants
2571634|NCT02513732|Secondary|Number of Participants With Target Lesion Failure (TLF)|TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 8 months|ITT population|||Participants|||Count of Participants
2571635|NCT02513732|Secondary|Number of Participants With Target Lesion Failure (TLF)|TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).|During hospitalization|ITT population|||Participants|||Count of Participants
2571636|NCT02513732|Secondary|Number of Participants With Cardiac Death or Target-Vessel MI|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).|0 to 5 years|ITT population|||Participants|||Count of Participants
2571637|NCT02513732|Secondary|Number of Participants With Cardiac Death or Target-Vessel MI|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).|0 to 4 years|ITT population|||Participants|||Count of Participants
2571638|NCT02513732|Secondary|Number of Participants With Cardiac Death or Target-Vessel MI|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).|0 to 3 years|ITT population|||Participants|||Count of Participants
2571639|NCT02513732|Secondary|Number of Participants With Cardiac Death or Target-Vessel MI|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).|0 to 2 years|ITT population|||Participants|||Count of Participants
2571640|NCT02513732|Secondary|Number of Participants With Cardiac Death or Target-Vessel MI|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).|0 to 1 year|ITT population|||Participants|||Count of Participants
2571641|NCT02513732|Secondary|Number of Participants With Cardiac Death or Target-Vessel MI|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).|0 to 8 months|ITT population|||Participants|||Count of Participants
2571642|NCT02513732|Secondary|Number of Participants With Cardiac Death or Target-Vessel MI|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).|During hospitalization|ITT population|||Participants|||Count of Participants
2571643|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 5 years|ITT population|||Participants|||Count of Participants
2571644|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 4 years|ITT population|||Participants|||Count of Participants
2571645|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 3 years|ITT population|||Participants|||Count of Participants
2571646|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 2 years|ITT population|||Participants|||Count of Participants
2571647|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 1 year|ITT population|||Participants|||Count of Participants
2571648|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 8 months|ITT population|||Participants|||Count of Participants
2571649|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|During hospitalization|ITT population|||Participants|||Count of Participants
2571661|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|0 to 1 year|ITT population|||Participants|||Count of Participants
2571662|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|0 to 8 months|ITT population|||Participants|||Count of Participants
2571650|NCT02513732|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 5 years|ITT population|||Participants|||Count of Participants
2571651|NCT02513732|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 4 years|ITT population|||Participants|||Count of Participants
2571652|NCT02513732|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 3 years|ITT population|||Participants|||Count of Participants
2571653|NCT02513732|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 2 years|ITT population|||Participants|||Count of Participants
2571654|NCT02513732|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 1 year|ITT population|||Participants|||Count of Participants
2571655|NCT02513732|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 8 months|ITT population|||Participants|||Count of Participants
2571656|NCT02513732|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|During hospitalization|ITT population|||Participants|||Count of Participants
2571657|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|0 to 5 years|ITT population|||Participants|||Count of Participants
2571658|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|0 to 4 years|ITT population|||Participants|||Count of Participants
2571659|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|0 to 3 years|ITT population|||Participants|||Count of Participants
2571660|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|0 to 2 years|ITT population|||Participants|||Count of Participants
2571663|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|During hospitalization|ITT population|||Participants|||Count of Participants
2571664|NCT02513732|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).|0 to 5 years|ITT population|||Participants|||Count of Participants
2571665|NCT02513732|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).|0 to 4 years|ITT population|||Participants|||Count of Participants
2571666|NCT02513732|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).|0 to 3 years|ITT population|||Participants|||Count of Participants
2571667|NCT02513732|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).|0 to 2 years|ITT population|||Participants|||Count of Participants
2571668|NCT02513732|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).|0 to 1 year|ITT population|||Participants|||Count of Participants
2571669|NCT02513732|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).|0 to 8 months|ITT population|||Participants|||Count of Participants
2571670|NCT02513732|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, nonTLR).|During hospitalization|ITT population|||Participants|||Count of Participants
2571671|NCT02513732|Secondary|Number of Participants With Target Vessel Revascularization(Non-TLR)|Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.|0 to 5 years|ITT population|||Participants|||Count of Participants
2571672|NCT02513732|Secondary|Number of Participants With Target Vessel Revascularization(Non-TLR)|Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.|0 to 4 years|ITT population|||Participants|||Count of Participants
2571673|NCT02513732|Secondary|Number of Participants With Target Vessel Revascularization(Non-TLR)|Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.|0 to 3 years|ITT population|||Participants|||Count of Participants
2571674|NCT02513732|Secondary|Number of Participants With Target Vessel Revascularization(Non-TLR)|Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.|0 to 2 years|ITT population|||Participants|||Count of Participants
2571675|NCT02513732|Secondary|Number of Participants With Target Vessel Revascularization(Non-TLR)|Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.|0 to 1 year|ITT population|||Participants|||Count of Participants
2571676|NCT02513732|Secondary|Number of Participants With Target Vessel Revascularization(Non-TLR)|Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.|0 to 8 months|ITT population|||Participants|||Count of Participants
2571677|NCT02513732|Secondary|Number of Participants With Target Vessel Revascularization(Non-TLR)|Target vessel revascularization (TVR) includes ischemia driven TVR, non-TLR and non- ischemia driven TVR, non-TLR.|During hospitalization|ITT population|||Participants|||Count of Participants
2571678|NCT02513732|Secondary|Number of Participants With Target Vessel Failure(TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 5 years|ITT population|||Participants|||Count of Participants
2571679|NCT02513732|Secondary|Number of Participants With Target Vessel Failure(TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 4 years|ITT population|||Participants|||Count of Participants
2571680|NCT02513732|Secondary|Number of Participants With Target Vessel Failure(TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 3 years|ITT population|||Participants|||Count of Participants
2571681|NCT02513732|Secondary|Number of Participants With Target Vessel Failure(TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 2 years|ITT population|||Participants|||Count of Participants
2571682|NCT02513732|Secondary|Number of Participants With Target Vessel Failure(TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 1 year|ITT population|||Participants|||Count of Participants
2571683|NCT02513732|Secondary|Number of Participants With Target Vessel Failure(TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 8 months|ITT population|||Participants|||Count of Participants
2571684|NCT02513732|Secondary|Number of Participants With Target Vessel Failure(TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|During hospitalization|ITT population|||Participants|||Count of Participants
2571685|NCT02513732|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|0 to 5 years|ITT population|||Participants|||Count of Participants
2571699|NCT02513732|Secondary|Number of Participants With MI Related to Target Vessel|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|0 to 5 years|ITT population|||Participants|||Count of Participants
2571700|NCT02513732|Secondary|Number of Participants With MI Related to Target Vessel|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|0 to 4 years|ITT population|||Participants|||Count of Participants
2571701|NCT02513732|Secondary|Number of Participants With MI Related to Target Vessel|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|0 to 3 years|ITT population|||Participants|||Count of Participants
2571702|NCT02513732|Secondary|Number of Participants With MI Related to Target Vessel|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|0 to 2 years|ITT population|||Participants|||Count of Participants
2571703|NCT02513732|Secondary|Number of Participants With MI Related to Target Vessel|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|0 to 1 year|ITT population|||Participants|||Count of Participants
2571704|NCT02513732|Secondary|Number of Participants With MI Related to Target Vessel|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|0 to 8 months|ITT population|||Participants|||Count of Participants
2571705|NCT02513732|Secondary|Number of Participants With MI Related to Target Vessel|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|During hospitalization|ITT population|||Participants|||Count of Participants
2571706|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)|0 to 5 years|ITT population|||Participants|||Count of Participants
2571707|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)|0 to 4 years|ITT population|||Participants|||Count of Participants
2571708|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)|0 to 3 Years|ITT population|||Participants|||Count of Participants
2571709|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)|0 to 2 years|ITT population|||Participants|||Count of Participants
2571710|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)|0 to 1 year|ITT population|||Participants|||Count of Participants
2571711|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)|0 to 8 months|ITT population|||Participants|||Count of Participants
2571712|NCT02513732|Secondary|Number of Participants Experienced Cardiac Death|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)|During hospitalization|ITT population|||Participants|||Count of Participants
2571787|NCT02513719|Secondary|Number of Participants With Target Lesion Failure|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 3 years|ITT population.|||Participants|||Count of Participants
2571713|NCT02513732|Secondary|Number of Participants With Myocardial Infarction|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|0 to 5 years|ITT population|||Participants|||Count of Participants
2571714|NCT02513732|Secondary|Number of Participants With Myocardial Infarction|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|0 to 4 years|ITT population|||Participants|||Count of Participants
2571715|NCT02513732|Secondary|Number of Participants With Myocardial Infarction|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|0 to 3 years|ITT population|||Participants|||Count of Participants
2571716|NCT02513732|Secondary|Number of Participants With Myocardial Infarction|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|0 to 2 years|ITT population|||Participants|||Count of Participants
2571717|NCT02513732|Secondary|Number of Participants With Myocardial Infarction|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|0 to 1 year|ITT population|||Participants|||Count of Participants
2571718|NCT02513732|Secondary|Number of Participants With Myocardial Infarction|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|0 to 8 months|ITT population|||Participants|||Count of Participants
2571719|NCT02513732|Secondary|Number of Participants With Myocardial Infarction|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|During hospitalization|ITT population|||Participants|||Count of Participants
2571720|NCT02513732|Secondary|Number of Participants With Target Lesion Revascularization Based on Ischemia Findings|Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.|0 to 5 years|ITT population|||Participants|||Count of Participants
2571721|NCT02513732|Secondary|Number of Participants With Target Lesion Revascularization Based on Ischemia Findings|Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.|0 to 4 years|ITT population|||Participants|||Count of Participants
2571722|NCT02513732|Secondary|Number of Participants With Target Lesion Revascularization Based on Ischemia Findings|Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.|0 to 3 years|ITT population|||Participants|||Count of Participants
2571723|NCT02513732|Secondary|Number of Participants With Target Lesion Revascularization Based on Ischemia Findings|Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.|0 to 2 years|ITT population|||Participants|||Count of Participants
2571724|NCT02513732|Secondary|Number of Participants With Target Lesion Revascularization Based on Ischemia Findings|Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.|0 to 1 year|ITT population|||Participants|||Count of Participants
2571725|NCT02513732|Secondary|Number of Participants With Target Lesion Revascularization Based on Ischemia Findings|Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.|0 to 8 months|ITT population|||Participants|||Count of Participants
2571726|NCT02513732|Secondary|Number of Participants With Target Lesion Revascularization Based on Ischemia Findings|Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.|During hospitalization|ITT population|||Participants|||Count of Participants
2571727|NCT02513732|Secondary|Number of Participants Experienced Death|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 5 years|ITT population|||Participants|||Count of Participants
2571728|NCT02513732|Secondary|Number of Participants Experienced Death|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 4 years|ITT population|||Participants|||Count of Participants
2571729|NCT02513732|Secondary|Number of Participants Experienced Death|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 3 years|ITT population|||Participants|||Count of Participants
2571730|NCT02513732|Secondary|Number of Participants Experienced Death|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 2 years|ITT population|||Participants|||Count of Participants
2571731|NCT02513732|Secondary|Number of Participants Experienced Death|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 1 year|ITT population|||Participants|||Count of Participants
2571732|NCT02513732|Secondary|Number of Participants Experienced Death|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 8 months|ITT population|||Participants|||Count of Participants
2571733|NCT02513732|Secondary|Number of Participants Experienced Death|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|During hospitalization|ITT population|||Participants|||Count of Participants
2571734|NCT02513732|Secondary|Number of Participants Using Antiplatelet Therapy|Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.|5 years observation day from the procedure day|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2571735|NCT02513732|Secondary|Number of Participants Using Antiplatelet Therapy|Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.|4 years observation day from the procedure day|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2571736|NCT02513732|Secondary|Number of Participants Using Antiplatelet Therapy|Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.|3 years observation day from the procedure day|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2571737|NCT02513732|Secondary|Number of Participants Using Antiplatelet Therapy|Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.|2 years observation day from the procedure day|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||participants|||Number
2571738|NCT02513732|Secondary|Number of Participants Using Antiplatelet Therapy|Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.|1 year observation day from the procedure day)|ITT population|||participants|||Number
2571739|NCT02513732|Secondary|Number of Participants Using Antiplatelet Therapy|Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.|8 months observation day from the procedure day|ITT population|||participants|||Number
2571740|NCT02513732|Secondary|Number of Participants Using Antiplatelet Therapy|Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.|Date of discharge from procedure day|ITT population|||participants|||Number
2571741|NCT02513732|Secondary|Number of Participants Using Antiplatelet Therapy|Number of patients using aspirin, clopidogrel, ticlopidine, cilostazol,prasugrel, compounding agents and other agents.|At baseline before procedure|ITT population|||participants|||Number
2571742|NCT02513732|Secondary|Percent Diameter Stenosis (%DS)|In-segment, In-stent, Proximal and Distal. The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|During follow-up, at 8 months post procedure|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percent Diameter Stenosis|Number of lesions|Standard Deviation|Mean
2571743|NCT02513732|Secondary|Percent Diameter Stenosis (%DS)|In-segment, In-stent, Proximal and Distal. The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|Immediately after the procedure|ITT population|||Percent Diameter stenosis|Number of lesions|Standard Deviation|Mean
2571744|NCT02513732|Secondary|Percent Diameter Stenosis (%DS)|In-segment, In-stent, Proximal and Distal. The value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|Pre-procedure|ITT population|||Percent Diameter stenosis|Number of lesions|Standard Deviation|Mean
2571745|NCT02513732|Primary|Number of Participants With Stent Thrombosis: Late|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|30 days to 1 year post stent implantation-Day 212|Intend To Treat population(ITT population)|||Participants|||Count of Participants
2571746|NCT02513719|Secondary|Net Gain: In-stent, In-segment|Difference between acute gain and late loss.|Post-Procedure (on day 0)||||Millimeter|Target lesions|Standard Deviation|Mean
2571747|NCT02513719|Secondary|Late Loss(LL): In-stent,In-segment,Proximal, and Distal|Proximal and distal late loss was calculated by [post-procedure minimum lumen diameter (MLD)] - [MLD at 8 months].|8 months|ITT population|||Millimeter|Target lesions|Standard Deviation|Mean
2571748|NCT02513719|Secondary|Acute Gain: In-stent,In-segment|The acute gain was defined as the difference between post- and preprocedural minimal lumen diameter (MLD).|Pre procedure to post procedure (on day 0)|ITT population.|||Millimeter|Target lesions|Standard Deviation|Mean
2571749|NCT02513719|Secondary|Number of Participants With Cardiac Death or Target Vessel MI|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).|0 to 5 years|ITT population.|||Participants|||Count of Participants
2571750|NCT02513719|Secondary|Number of Participants With Cardiac Death or Target Vessel MI|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).|0 to 4 years|ITT population.|||Participants|||Count of Participants
2571751|NCT02513719|Secondary|Number of Participants With Cardiac Death or Target Vessel MI|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).|0 to 3 years|ITT population.|||Participants|||Count of Participants
2571752|NCT02513719|Secondary|Number of Participants With Cardiac Death or Target Vessel MI|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).|0 to 2 years|ITT population.|||Participants|||Count of Participants
2571753|NCT02513719|Secondary|Number of Participants With Cardiac Death or Target Vessel-MI|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).|0 to 1 year|ITT population.|||Participants|||Count of Participants
2571754|NCT02513719|Secondary|Number of Participants With Cardiac Death or Target-Vessel MI|Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).|0 to 8 months|ITT population.|||Participants|||Count of Participants
2571755|NCT02513719|Secondary|Number of Participants With Cardiac Death or MI|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 5 years|ITT population.|||Participants|||Count of Participants
2571756|NCT02513719|Secondary|Number of Participants With Cardiac Death or MI|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 4 years|ITT population.|||Participants|||Count of Participants
2571757|NCT02513719|Secondary|Number of Participants With Cardiac Death or MI|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 3 years|ITT population.|||Participants|||Count of Participants
2571758|NCT02513719|Secondary|Number of Participants With Cardiac Death or MI|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 2 years|ITT population.|||Participants|||Count of Participants
2571759|NCT02513719|Secondary|Number of Participants With Cardiac Death or MI|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 1 year|ITT population.|||Participants|||Count of Participants
2571760|NCT02513719|Secondary|Number of Participants With Cardiac Death or MI|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 8 months|ITT population.|||Participants|||Count of Participants
2571761|NCT02513719|Secondary|Number of Participants With Death or MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|0 to 5 years|ITT population.|||Participants|||Count of Participants
2571762|NCT02513719|Secondary|Number of Participants With Death or MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|0 to 4 years|ITT population.|||Participants|||Count of Participants
2571763|NCT02513719|Secondary|Number of Participants With Death or MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|0 to 3 years|ITT population.|||Participants|||Count of Participants
2571788|NCT02513719|Secondary|Number of Participants With Target Lesion Failure|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 2 years|ITT population.|||Participants|||Count of Participants
2571764|NCT02513719|Secondary|Number of Participants With Death or MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|0 to 2 years|ITT population.|||Participants|||Count of Participants
2571765|NCT02513719|Secondary|Number of Participants With Death or MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI)~Q wave MI Development of new, pathological Q wave on the ECG.~Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 1 year|ITT population.|||Participants|||Count of Participants
2571766|NCT02513719|Secondary|Number of Participants With Death or MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI)~Q wave MI Development of new, pathological Q wave on the ECG.~Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 8 months|ITT population.|||Participants|||Count of Participants
2571767|NCT02513719|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and clinically indicated target lesion revascularization (CI-TLR).|0 to 5 years|ITT population.|||Participants|||Count of Participants
2571768|NCT02513719|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and clinically indicated target lesion revascularization (CI-TLR).|0 to 4 years|ITT population.|||Participants|||Count of Participants
2571769|NCT02513719|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and clinically indicated target lesion revascularization (CI-TLR).|0 to 3 years|ITT population.|||Participants|||Count of Participants
2571770|NCT02513719|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and clinically indicated target lesion revascularization (CI-TLR).|0 to 2 years|ITT population.|||Participants|||Count of Participants
2571771|NCT02513719|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and clinically indicated target lesion revascularization (CI-TLR).|0 to 1 year|ITT population.|||Participants|||Count of Participants
2571772|NCT02513719|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Clinically indicated target lesion revascularization (CI-TLR).|0 to 8 months|ITT population.|||Participants|||Count of Participants
2571773|NCT02513719|Secondary|Number of Participants With Target Vessel Failure|Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).|0 to 5 years|ITT population.|||Participants|||Count of Participants
2571774|NCT02513719|Secondary|Number of Participants With Target Vessel Failure|Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).|0 to 4 years|ITT population.|||Participants|||Count of Participants
2571775|NCT02513719|Secondary|Number of Participants With Target Vessel Failure|Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).|0 to 3 years|ITT population.|||Participants|||Count of Participants
2571776|NCT02513719|Secondary|Number of Participants With Target Vessel Failure|Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).|0 to 2 years|ITT population.|||Participants|||Count of Participants
2571777|NCT02513719|Secondary|Number of Participants With Target Vessel Failure|Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, nonTLR).|0 to 1 year|ITT population.|||Participants|||Count of Participants
2571778|NCT02513719|Secondary|Number of Participants With Target Vessel Failure|Target vessel failure includes cardiac death, MI, ischemia driven TLR, ischemia driven TVR, non TLR and ischemia driven TVR (TLR or TVR, nonTLR).|0 to 8 months|ITT population.|||Participants|||Count of Participants
2571779|NCT02513719|Secondary|Number of Participants With All Death/All MI/All Revascularization||0 to 5 years|ITT population.|||Participants|||Count of Participants
2571780|NCT02513719|Secondary|Number of Participants With All Death/All MI/All Revascularization||0 to 4 years|ITT population.|||Participants|||Count of Participants
2571781|NCT02513719|Secondary|Number of Participants With All Death/All MI/All Revascularization||0 to 3 years|ITT population.|||Participants|||Count of Participants
2571782|NCT02513719|Secondary|Number of Participants With All Death/All MI/All Revascularization||0 to 2 years|ITT population.|||Participants|||Count of Participants
2571789|NCT02513719|Secondary|Number of Participants With Target Lesion Failure|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 1 year|ITT population.|||Participants|||Count of Participants
2571790|NCT02513719|Secondary|Number of Participants With Target Lesion Failure|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 8 months|ITT population.|||Participants|||Count of Participants
2571791|NCT02513719|Secondary|Number of Participants With Hemorrhage|"Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.~Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention; Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise; Mild: Bleeding that does not meet criteria for either moderate or severe bleeding."|0 to 5 years|ITT population.|||Participants|||Count of Participants
2571792|NCT02513719|Secondary|Number of Participants With Hemorrhage|"Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.~Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention; Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise; Mild: Bleeding that does not meet criteria for either moderate or severe bleeding."|0 to 4 years|ITT population.|||Participants|||Count of Participants
2571793|NCT02513719|Secondary|Number of Participants With Hemorrhage|"Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.~Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention; Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise; Mild: Bleeding that does not meet criteria for either moderate or severe bleeding."|0 to 3 years|ITT population.|||Participants|||Count of Participants
2571794|NCT02513719|Secondary|Number of Participants With Hemorrhage|"Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.~Severe or life-threatening:~Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention~Moderate:~Bleeding that requires blood transfusion but does not result in hemodynamic compromise~Mild:~Bleeding that does not meet criteria for either moderate or severe bleeding"|0 to 2 years|ITT population.|||Participants|||Count of Participants
2571795|NCT02513719|Secondary|Number of Participants With Hemorrhage|"Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.~Severe or life-threatening:~Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention~Moderate:~Bleeding that requires blood transfusion but does not result in hemodynamic compromise~Mild:~Bleeding that does not meet criteria for either moderate or severe bleeding"|0 to 1 year|ITT population.|||Participants|||Count of Participants
2571796|NCT02513719|Secondary|Number of Participants With Hemorrhage|"Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.~Severe or life-threatening:~Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention~Moderate:~Bleeding that requires blood transfusion but does not result in hemodynamic compromise~Mild:~Bleeding that does not meet criteria for either moderate or severe bleeding"|0 to 8 months|ITT population.|||Participants|||Count of Participants
2571797|NCT02513719|Secondary|Number of Participants With All Revascularization|"Revascularization:~Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.~Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.~Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.~Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel."|0 to 5 years|ITT population.|||Participants|||Count of Participants
2571798|NCT02513719|Secondary|Number of Participants With All Revascularization|"Revascularization:~Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.~Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.~Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.~Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel."|0 to 4 years|ITT population.|||Participants|||Count of Participants
2571799|NCT02513719|Secondary|Number of Participants With All Revascularization|"Revascularization:~Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.~Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.~Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.~Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel."|0 to 3 years|ITT population.|||Participants|||Count of Participants
2571800|NCT02513719|Secondary|Number of Participants With All Revascularization|"Revascularization:~Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.~Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.~Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.~Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel."|0 to 2 years|ITT population.|||Participants|||Count of Participants
2571801|NCT02513719|Secondary|Number of Participants With All Revascularization|"Revascularization:~Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.~Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.~Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.~Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel."|0 to 1 year|ITT population.|||Participants|||Count of Participants
2571802|NCT02513719|Secondary|Number of Participants With All Revascularization|"Revascularization:~Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.~Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.~Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.~Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel."|0 to 8 months|ITT population.|||Participants|||Count of Participants
2571803|NCT02513719|Secondary|Number of Participants With Non-target Vessel Revascularization (Non-TVR)|Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.|0 to 5 years|ITT population.|||Participants|||Count of Participants
2571804|NCT02513719|Secondary|Number of Participants With Non-target Vessel Revascularization (Non-TVR)|Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.|0 to 4 years|ITT population.|||Participants|||Count of Participants
2571805|NCT02513719|Secondary|Number of Participants With Non-target Vessel Revascularization (Non-TVR)|Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.|0 to 3 years|ITT population.|||Participants|||Count of Participants
2571806|NCT02513719|Secondary|Number of Participants With Non-target Vessel Revascularization (Non-TVR)|Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.|0 to 2 years|ITT population.|||Participants|||Count of Participants
2571807|NCT02513719|Secondary|Number of Participants With Non-target Vessel Revascularization (Non-TVR)|Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.|0 to 1 year|ITT population.|||Participants|||Count of Participants
2571808|NCT02513719|Secondary|Number of Participants With Non-target Vessel Revascularization (Non-TVR)|Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.|0 to 8 months|ITT population.|||Participants|||Count of Participants
2571809|NCT02513719|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, non-TLR)|0-5 years|ITT popuation|||Participants|||Count of Participants
2571810|NCT02513719|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, non-TLR)|0-4 years|ITT popuation|||Participants|||Count of Participants
2571811|NCT02513719|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, non-TLR)|0-3 years|ITT popuation|||Participants|||Count of Participants
2571812|NCT02513719|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)|The number of patient with Ischemia-driven Target vessel revascularization (TLR or TVR, non-TLR)|0 to 2 years|ITT population.|||Participants|||Count of Participants
2571813|NCT02513719|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, non-TLR)|0 to 1 year|ITT population.|||Participants|||Count of Participants
2571814|NCT02513719|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR, Non-TLR)|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR, non-TLR) or non-ischemia driven TVR (TLR or TVR, non-TLR)|0 to 8 months|ITT population.|||Participants|||Count of Participants
2571815|NCT02513719|Secondary|Number of Participants With Target Lesion Revascularization|Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR|0-5 years|ITT|||Participants|||Count of Participants
2571844|NCT02513641|Secondary|2-hour Glucose Area-under-the-curve|2-hour glucose area-under-the-curve (mg/dL x hour) was determined using an oral glucose tolerance test.|0, 0.5, 1, 1.5, and 2 hours at Baseline and Post-Moderate Hypoxia (14 days)||||mg/dL x hour||Standard Deviation|Mean
2571816|NCT02513719|Secondary|Number of Participants With Target Lesion Revascularization|Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR|0-4 years|ITT|||Participants|||Count of Participants
2571817|NCT02513719|Secondary|Number of Participants With Target Lesion Revascularization|Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR|0-3 years|ITT|||Participants|||Count of Participants
2571818|NCT02513719|Secondary|Number of Participants With Target Lesion Revascularization|Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR|0 to 2 years|ITT population.|||Participants|||Count of Participants
2571819|NCT02513719|Secondary|Number of Participants With Target Lesion Revascularization|Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR|0 to 1 year|ITT population.|||Participants|||Count of Participants
2571820|NCT02513719|Secondary|Number of Participants With Target Lesion Revascularization|Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR|0 to 8 months|ITT population.|||Participants|||Count of Participants
2571821|NCT02513719|Secondary|Number of Participants With Myocardial Infarction|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0-5 years|ITT population|||Participants|||Count of Participants
2571822|NCT02513719|Secondary|Number of Participants With Myocardial Infarction|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0-4 years|ITT population|||Participants|||Count of Participants
2571823|NCT02513719|Secondary|Number of Participants With Myocardial Infarction|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0-3 years|ITT population|||Participants|||Count of Participants
2571824|NCT02513719|Secondary|Number of Participants With Myocardial Infarction|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 2 years|ITT population.|||Participants|||Count of Participants
2571825|NCT02513719|Secondary|Number of Participants With Myocardial Infarction|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 1 year|ITT population.|||Participants|||Count of Participants
2571826|NCT02513719|Secondary|Number of Participants With Myocardial Infarction|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|0 to 8 months|ITT population|||Participants|||Count of Participants
2571827|NCT02513719|Secondary|Number of Death|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0-５ years|ITT population|||Participants|||Count of Participants
2571828|NCT02513719|Secondary|Number of Death|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0-4 years|ITT population|||Participants|||Count of Participants
2571829|NCT02513719|Secondary|Number of Death|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0-3 years|ITT population|||Participants|||Count of Participants
2571830|NCT02513719|Secondary|Number of Death|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 2 years|ITT population.|||Participants|||Count of Participants
2571831|NCT02513719|Secondary|Number of Death|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 1 year|Intent-to-treat (ITT) population.|||Participants|||Count of Participants
2571832|NCT02513719|Secondary|Number of Death|Death includes cardiac death, non-cardiac death and non-coronary death.|0 to 8 months|Intent-to-treat (ITT) population.|||Participants|||Count of Participants
2571833|NCT02513719|Secondary|Success Rate: XIENCE PRIME Implant Success by Patient|"The stent lengths used were 8 mm, 12 mm, and 15 mm,18 mm, 23 mm, and 28 mm and the stent diameter was 2.25 mm.~Implant success is assessed as per physicians decision, but means that the stent could be implanted at the intended location."|< or = 1 day|ITT population.|||participants||95% Confidence Interval|Number
2571834|NCT02513719|Secondary|Success Rate: Percentage of Lesions With Procedural Success|Achievement of final in-scaffold/stent residual stenosis of less than 50% by QCA with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (less than or equal to 7 days).|< or = 1 day|ITT population.|||Percentage of lesions|Lesions|95% Confidence Interval|Number
2571835|NCT02513719|Secondary|Success Rate: Percentage of Devices With Implant Success|"The stent lengths used were 8 mm, 12 mm, and 15 mm,18 mm, 23 mm, and 28 mm and the stent diameter was 2.25mm.~Successful delivery and deployment of the first study scaffold/stent the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 50% by quantitative coronary angiography (QCA)."|< or = 1 day||||percentage of devices|XIENCE PRIME SV stents|95% Confidence Interval|Number
2571836|NCT02513719|Secondary|Percent Diameter Stenosis (%DS)|The value calculated as 100 * (1- minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|8 months|The number of participants analyzed includes subjects who received angiographic follow-up at 8 months.|||Percent Diameter stenosis|Target lesions|Standard Deviation|Mean
2571837|NCT02513719|Secondary|Percent Diameter Stenosis (%DS)|The value calculated as 100 * (1- minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|post procedure (on day 0)|ITT population.|||Percent Diameter stenosis|Target lesions QCA|Standard Deviation|Mean
2571838|NCT02513719|Secondary|Percent Diameter Stenosis (%DS)|The value calculated as 100 * (1- minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|Pre-procedure|ITT population.|||Percent Diameter stenosis|Target lesions QCA|Standard Deviation|Mean
2571839|NCT02513719|Secondary|Number of Participants With Stent Thrombosis: Very Late|"Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Very late stent thrombosis : >1 year after stent implantation."|>1 year post stent implantation|ITT population.|||Participants|||Count of Participants
2571840|NCT02513719|Primary|Number of Participants With Stent Thrombosis: Late|"Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Late stent thrombosis : >30 days to 1 year after stent implantation"|30 days to 1 year post stent implantation|ITT population.|||Participants|||Count of Participants
2571841|NCT02513719|Primary|Number of Participants With Stent Thrombosis: Subacute|"Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Subacute stent thrombosis : >24 hours to 30 days after stent implantation"|>24 hours to 30 days post stent implantation|ITT population.|||Participants|||Count of Participants
2571842|NCT02513719|Primary|Number of Participants With Stent Thrombosis: Acute|"Stent/Scaffold Thrombosis (per ARC): Stent/Scaffold Thrombosis should be reported as a cumulative value over time and at various individual time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timing:~Acute stent thrombosis: 0 to 24 hours after stent implantation"|0-24 hours post stent implantation|Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2571843|NCT02513641|Secondary|2-hour Insulin Area-under-the-curve Via Oral Glucose Tolerance Test|2-hour insulin area-under-the-curve (μU/mL x hr) was determined using an oral glucose tolerance test.|0, 0.5, 1, 1.5, and 2 hours at Baseline and Post-Moderate Hypoxia (14 days)||||uU/mL x hour||Standard Deviation|Mean
2571845|NCT02513641|Secondary|Beta-cell Function|Beta-cell function was determined using an oral glucose tolerance test. Beta-cell function was estimated by the Disposition Index, or the product of insulin sensitivity and insulin secretion: DI (unitless) = Matsuda Index (WBISI) x Insulinogenic Index (IGI).|Baseline and Post-Moderate Hypoxia (14 days)||||unitless||Standard Deviation|Mean
2571846|NCT02513641|Secondary|Insulin Secretion|Insulin secretion was determined using an oral glucose tolerance test. Insulin secretion was estimated using the Insulinogenic Index (IGI), an index of first-phase insulin response, and calculated from the ratio of the increments of serum insulin to glucose measured at 30 minutes: IGI (unitless) = (Ins30 - Ins0)/(Glu30 - Glu0), where insulin and glucose from 0 and 30 minutes are used.|Baseline and Post-Moderate Hypoxia (14 days)||||unitless||Standard Deviation|Mean
2571847|NCT02513641|Primary|Insulin Sensitivity|Insulin sensitivity was determined using an oral glucose tolerance test. Insulin sensitivity was estimated using the whole-body insulin sensitivity index (WBISI), also known as the Matsuda Index (unitless): WBISI = 10,000 / [square root of (Glu0 x Ins0) x (mean glucose x mean insulin during an oral glucose tolerance test)] where Glu0 and Ins0 denote baseline glucose and insulin concentrations.|Baseline and Post-Moderate Hypoxia (14 days)||||unitless||Standard Deviation|Mean
2571848|NCT02513550|Secondary|Number of Participants With Anti-Ixekizumab Antibodies|Number of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group.|Baseline through Week 52|All randomized participants who received at least 1 dose of Ixekizumab and had evaluable anti-ixekizumab antibody measurement. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.|||participants|||Number
2571849|NCT02513550|Secondary|Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab|Trough concentrations at steady state of Ixekizumab were evaluated.|Predose, Week 4, 12, 24, 36 and 52 Post dose|All randomized participants analyzed according to treatment to which they were assigned with evaluable PK samples that met the definition of being a trough concentration. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.|||microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2571850|NCT02513550|Secondary|Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS|EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (no pain) to 100mm VAS (severe pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post baseline EQ-5D-5L VAS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.|||mm||Standard Error|Least Squares Mean
2571851|NCT02513550|Secondary|Change From Baseline in Skin Pain Visual Analog Scale (VAS)|The pain VAS is a participant-administered single-item scale designed to measure Skin pain from Psoriasis using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's skin pain from Psoriasis is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no skin pain) to 100 mm (severe skin pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post-baseline skin pain VAS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.|||mm||Standard Error|Least Squares Mean
2571852|NCT02513550|Secondary|Change From Baseline in Itch NRS Score|"The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. LS mean change from baseline in PSSI was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured."|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post-baseline Itch NRS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.|||units on a scale||Standard Error|Least Squares Mean
2571853|NCT02513550|Secondary|Change From Baseline in DLQI Total Score|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment). LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured."|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post-baseline DLQI data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.|||units on a scale||Standard Error|Least Squares Mean
2571959|NCT02512679|Secondary|Number of Participants Who Were Disease Progression-Free and Death-Free at 1 Year Post-transplant|Evaluation for engraftment, correction of the disease, transplant related complications and event-free survival and overall survival of the subjects post-transplant was undertaken by standard measures and evaluation of disease with disease-specific testing.|1 yr|Subjects receiving dose level 1 of Cyclophosphamide event free survival post transplant at 100 days was 95% and 90% 1 year.|||participants|||Number
2571854|NCT02513550|Secondary|Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Total Score of 0 and 1 (DLQI [0,1])|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment). Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis."|Week 52|All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.|||Percentage of participants|||Number
2571855|NCT02513550|Secondary|Percentage of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) ≥4 Point Reduction From Baseline|"The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis."|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned and who had baseline Itch NRS score greater than or equal to (>=) 4. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups|||Percentage of participants|||Number
2571856|NCT02513550|Secondary|Mean Change From Baseline in Palmoplantar PASI (PPASI)|The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned and had baseline palmoplantar Ps involvement and had post-baseline measurement. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.|||units on a scale||Standard Error|Least Squares Mean
2571857|NCT02513550|Secondary|Mean Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score|The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90-100%) with a total score ranging from 0 (less severity) to 72 (more severity). LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned and had baseline scalp involvement and had a post-baseline measurement. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.|||units on a scale||Standard Error|Least Squares Mean
2571858|NCT02513550|Secondary|Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail (fn) Ps. This scale is used to evaluate the severity of fn bed Ps and fn matrix Ps by area of involvement in the fn unit. The fn is divided with imaginary horizontal and longitudinal lines into quadrants. Each fn is given a score for fn bed Ps (0 to 4) and fn matrix Ps (0 to 4) depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed and fn matrix Ps in each quadrant. The NAPSI score of a fn is sum of scores in fn bed and fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from 0 to 80 (0 indicates no Ps, 80 indicates worst Ps). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned who had baseline fingernail involvement and had a post-baseline measurement. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.|||units on a scale||Standard Error|Least Squares Mean
2571859|NCT02513550|Secondary|Mean Change From Baseline in Percent Body Surface Area (BSA) Involvement|"The percentage involvement of psoriasis on each participant's body surface area (BSA) was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb.~LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured."|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned who had baseline and a post-baseline measurement for BSA affected by Psoriasis. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.|||Percent Body Surface Affected||Standard Error|Least Squares Mean
2571991|NCT02512393|Secondary|Endorphin Level||day 5||||ng/mL||Standard Deviation|Mean
2571992|NCT02512393|Other Pre-specified|Pain Attitudes Questionnaire-Revised Will be Compared Between the Two Groups for a Change Between Baseline and Day 5|This is a questionnaire to assess pain attitudes, such as stoicism, using a 5-point scale that ranges from strongly disagree to strongly agree. The higher the scale the more stoic.|Change from baseline and day 5|||||||
2572956|NCT02500537|Primary|The Primary Endpoint is the Incidence of Reported Device-related Adverse Events (AEs) Through 30 Days Following Indicated Abdominal or Thoracic Procedures.||Through 30 Days||||Device related adverse events|||Number
2571860|NCT02513550|Secondary|Percent Improvement in PASI|"The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.~Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured."|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned and had a baseline and post-baseline measurement for PASI. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.|||Percent change||Standard Error|Least Squares Mean
2571861|NCT02513550|Secondary|Change From Baseline in PASI|"The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.~Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured."|Baseline, Week 52|All randomized participants analyzed according to the treatment to which they were assigned and had a baseline and post-baseline measurement for PASI. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.|||units on a scale||Standard Error|Least Squares Mean
2571862|NCT02513550|Secondary|Percentage of Participants Achieving PASI 100|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week 52|All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.|||Percentage of participants|||Number
2571863|NCT02513550|Secondary|Percentage of Participants Achieving PASI 90|PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week 52|All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.|||Percentage of participants|||Number
2571864|NCT02513550|Secondary|Percentage of Participants Achieving sPGA (0)|"The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis."|Week 52|All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.|||Percentage of participants|||Number
2571865|NCT02513550|Primary|Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75)|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants who did not meet the clinical response criteria or had missing data at Week52 were considered non-responders for NRI analysis.|Week 52|All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.|||Percentage of participants|||Number
2571993|NCT02512393|Other Pre-specified|Positive and Negative Affect Scale Will be Compared Between the Two Groups for a Change Between Baseline and Day 5|This is a questionnaire using a 5-point scale that ranges from very slightly or not at all to extremely. The lower the scale the negative the affect and the higher the scare the positive the affect.|Change from baseline and day 5|||||||
2571998|NCT02512393|Primary|Conditioned Pain Modulation (CPM)|Conditioned pain modulation (CPM) will be done by using a cold pressor procedure on the skin. The measure is scored on a scale, which ranges from zero to infinity. A higher CPM score indicates higher pain inhibition.|day 5||||units on a scale||Standard Deviation|Mean
2571866|NCT02513550|Primary|Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)|"The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis."|Week 52|All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.|||Percentage of participants|||Number
2571867|NCT02513498|Secondary|Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale|Lee symptom scale (LSS) has subscales with min=0, max=100; results given are 12mo scores, with higher numbers indicating higher symptom burden.|1 year|25 of 50 participants were evaluable at 12mo due to missing patient survey data|||units on a scale||Full Range|Median
2571868|NCT02513498|Secondary|Symptoms as Measured by Patient Self-report--Human Activities Profile (HAP)|"HAP subscales have min=0 and max=94; results given are actual 12mo scores, with higher scores indicating better functioning.~Maximum Activity Score (MAS) is highest item number answered still doing. Represents highest oxygen demanding activity that respondent still performs.~Adjusted Activity Score (AAS) is MAS minus total number of stopped doing responses below MAS. A measure of usual daily activities.~Modified AAS is MAS minus total number of stopped doing responses below MAS but not penalized for not doing activities not permitted post transplant. The following items are not counted against the score:11,15,19,20,22,25,34,41,42,47,49,50,52,53,54,57,72,73,77,78."|1 year|25 of 50 participants were evaluable at 12mo due to missing patient survey data|||units on a scale||Full Range|Median
2571869|NCT02513498|Secondary|Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)|"FACT-BMT subscales have various min/max, see below; results given are actual 12mo scores, with higher scores indicating better functioning.~FACT physical well-being (0-28) FACT social/family well-being (0-28) FACT emotional well-being (0-24) FACT functional well-being (0-28) FACT Bone Marrow Transplant (BMT) subscale (0-40) FACT trial outcome index (0-96) FACT-General (G) (0-108) FACT-BMT total (0-148)"|1 year|25 of 50 participants were evaluable at 12mo due to missing patient survey data|||units on a scale||Full Range|Median
2571870|NCT02513498|Secondary|Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)|SF-36 subscales have min=0 and max=100; results given are actual scores at 12mo, with higher scores indicating higher quality of life.|1 year|25 of 50 participants were evaluable at 12mo due to missing patient survey data|||units on a scale||Full Range|Median
2571871|NCT02513498|Secondary|Use of Additional Systemic Immune Suppressive Therapies|Addition of therapy after ixazomib constitutes failure, could occur at any time from baseline to 12mo.|1 year||||Participants|||Count of Participants
2571872|NCT02513498|Secondary|Treatment Success|Treatment success will be estimated at 1 year with a composite outcome of complete resolution of all reversible chronic graft-versus-host disease (GVHD) manifestations, discontinuation of all systemic immune suppressive agents, and freedom from death or primary malignancy relapse after transplant.|1 year||||Participants|||Count of Participants
2571873|NCT02513498|Secondary|Probability of Overall Survival at 1 Year|Kaplan-Meier estimate assessed at 1 year for overall survival, defined as absence of death from any cause.|1 year||||probability of overall survival|||Number
2571874|NCT02513498|Secondary|Overall Response Rate (ORR) (Complete Response + Partial Response)|ORR at 6 months will be determined by both clinician-defined categories of complete response and partial response, as well as separately calculated according to the proposed response definitions of the NIH Consensus Conference.|6 months|Participants with missing response data are counted as failures; primarily missing due to failure to collect data in patients who stopped study drug but did not experience treatment failure.|||participants|||Number
2571875|NCT02513498|Secondary|Incidence of Discontinuation of All Systemic Immune Suppressive Therapies|The incidence of complete discontinuation of all systemic immune-suppressive therapies will be determined at 1 year.|1 year||||Participants|||Count of Participants
2571876|NCT02513498|Secondary|Probability of Failure-free Survival at 1 Year|Kaplan-Meier estimate assessed at 1 year for failure-free survival, defined as the absence of death from any cause, relapse or addition of secondary immune suppressive agents.|1 year||||probability of failure-free survival|||Number
2571877|NCT02513498|Secondary|Cumulative Incidence of Primary Malignancy Relapse|Defined as hematologic relapse or any unplanned intervention to prevent progression of disease in patients with evidence (molecular, cytogenetic, flow cytometric, radiographic) of malignant disease after transplantation.|1 year||||Participants|||Count of Participants
2571878|NCT02513498|Secondary|Probability of Non-relapse Mortality at 1 Year|Kaplan-Meier estimate assessed at 1 year for probability of non-relapse mortality, defined as death in the absence of primary malignancy relapse after transplant.|1 year||||non-relapse mortality probability|||Number
2571879|NCT02513498|Secondary|Complete Response (CR) Rate|Response will be determined by both clinician-defined, as well as separately calculated according to the proposed response definitions of the NIH Consensus Conference.|6 months|Participants who could be evaluated for response (not missing data)|||Participants|||Count of Participants
2571880|NCT02513498|Secondary|Biologic Studies|The biologic impact of proteasome inhibition in the treatment of chronic GVHD will be assessed.|Up to 6 months|Response to study drug too minimal to justify time and expense to perform biologic studies.|||Participants|||Count of Participants
2571881|NCT02513498|Primary|Probability of Treatment Failure at 6 Months|Kaplan-Meier estimate assessed at 6 months for probability of treatment failure, defined as addition of a line of systemic immune-suppressive therapy, recurrent malignancy, or death.|6 months||||Treatment failure probability|||Number
2571882|NCT02513498|Primary|Incidence of Adverse Events|According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0|Up to 30 days following completion of study treatment||||participants|||Number
2571999|NCT02512393|Primary|Conditioned Pain Modulation (CPM)|Conditioned pain modulation (CPM) will be done by using a cold pressor procedure on the skin. The measure is scored on a scale, which ranges from zero to infinity. A higher CPM score indicates higher pain inhibition.|baseline||||units on a scale||Standard Deviation|Mean
2571883|NCT02513459|Secondary|Mean Change From Baseline in Fecal Calprotectin (FCP) Profile by Visit|Fecal calprotectin (FCP) is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Stool samples were analyzed by a central laboratory for fecal calprotectin levels. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Negative values indicate improvement from baseline.|Weeks 0, 24, 56, 88, 120, 152, and 184|Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.|||μg/g||Standard Deviation|Mean
2571884|NCT02513459|Secondary|Mean Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) by Visit|Concentration of serum high-sensitivity C-reactive Protein (hs-CRP) was analyzed by a central laboratory. It is a general marker of inflammation that is sensitive to acute changes in inflammatory response, and higher levels indicate more inflammation. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Negative values indicate improvement from baseline.|Weeks 0, 8, 24, 40, 56, 72, 88, 104, 120, 128, 136, 152, 160, 176, and 184|Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.|||mg/L||Standard Deviation|Mean
2571885|NCT02513459|Secondary|Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score by Visit|The Inflammatory Bowel Disease Questionnaire (IBDQ) measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Positive values indicate improvement from baseline.|Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192|Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.|||units on a scale||Standard Deviation|Mean
2571886|NCT02513459|Secondary|Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score by Visit|The Inflammatory Bowel Disease Questionnaire (IBDQ) measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Positive values indicate improvement from baseline.|Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192|Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.|||units on a scale||Standard Deviation|Mean
2571887|NCT02513459|Secondary|Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic System Domain Score by Visit|The Inflammatory Bowel Disease Questionnaire (IBDQ) measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Positive values indicate improvement from baseline.|Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192|Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.|||units on a scale||Standard Deviation|Mean
2571888|NCT02513459|Secondary|Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain Score by Visit|The Inflammatory Bowel Disease Questionnaire (IBDQ) measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Positive values indicate improvement from baseline.|Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192|Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.|||units on a scale||Standard Deviation|Mean
2571931|NCT02512900|Secondary|Treatment-emergent Adverse Events Related to Laboratory Parameters|Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell count with differential, red blood cell count, hematocrit, hemoglobin and platelet count); serum chemistry: calcium, chloride, potassium, sodium, bicarbonate, aspartate transaminase, alanine transaminase, albumin, uric acid, creatinine, total bilirubin, glucose, alkaline phosphatase, blood urea nitrogen, total protein, and gamma glutamyl transferase; and urinalysis (nitrites, protein, glucose, ketones, urine drug screen, blood, and bilirubin). Number of participants with TEAEs related to laboratory evaluations were reported.|From the start of study drug administration up to end of follow-up period, assessed up to Day 85|As-treated Population|||Participants|||Number
2572000|NCT02512393|Primary|Punctate Mechanical Pain Sensitivity|Quantitative Sensory Testing (QST) by using punctate mechanical pain delivered by a calibrated nylon monofilament.|day 5||||kilopascal (kPa)||Standard Deviation|Mean
2571889|NCT02513459|Secondary|Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score by Visit|The Inflammatory Bowel Disease Questionnaire (IBDQ) measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Positive values indicate improvement from baseline.|Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192|Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.|||units on a scale||Standard Deviation|Mean
2571890|NCT02513459|Secondary|Mean Change From Baseline in Abdominal Pain (AP) Score By Visit|Participants were asked to rate and record daily abdominal pain on a scale of 0 to 3 [none (0), mild (1), moderate (2) and severe (3)]. The ratings in the prior 7 days were summed. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Negative values indicate improvement from baseline.|Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184|Observed case (OC) analysis was performed on the intent-to-treat (ITT) analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study.|||units on a scale||Standard Deviation|Mean
2571891|NCT02513459|Secondary|Mean Change From Baseline in Stool Frequency (SF) By Visit|Participants were asked to record the frequency of liquid stools on a daily basis. The number of liquid stools in the prior 7 days was summed. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). Negative values indicate improvement from baseline.|Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184|Observed case (OC) analysis was performed on the intent-to-treat (ITT) analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study.|||number of liquid stools in prior 7 days||Standard Deviation|Mean
2571892|NCT02513459|Secondary|Mean Change From Baseline in Simple Endoscopic Score (SES-CD) by Visit|SES-CD is calculated based the sum of individual segment values for four endoscopic variables (presence and size of ulcers, ulcerated surface, affected surface and presence of narrowing). Each variable in each segment is scored 0 to 3 resulting in SES-CD values ranging from 0 to 56 with higher scores indicating more severe disease. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). A negative change from baseline indicates improvement.|Weeks 0, 48, 104, 152, and 200|Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.|||units on a scale||Standard Deviation|Mean
2571893|NCT02513459|Secondary|Mean Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) by Visit|CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). A negative change from baseline indicates improvement.|Weeks 0, 48, 104, 152, and 200|Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.|||units on a scale||Standard Deviation|Mean
2571894|NCT02513459|Secondary|Mean Change From Baseline in Patient Reported Outcome 2 (PRO-2) Scores by Visit|The PRO-2 is calculated based on the sum of the weighted patient-reported subscores of CDAI for liquid or soft stool frequency [SF] plus abdominal pain [AP] in the 7 days prior to the study visit. The PRO-2 score is calculated by adding the values of the summed stool frequency scores multiplied by 2 plus the summed abdominal pain scores multiplied by 5. The SF and AP score at an assessment visit was the average of the daily values reported during the 7 days preceding the scheduled assessment visit. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). A negative change from baseline indicates improvement.|Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184|Observed case (OC) analysis was performed on the intent-to-treat (ITT) analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study.|||units on a scale||Standard Deviation|Mean
2571932|NCT02512900|Secondary|Treatment-emergent Adverse Events Related to Vital Sign Parameters and Physical Findings|Vital signs (blood pressure, temperature, pulse, and respiratory rate) were performed throughout the study. The TEAEs related to vital signs in participants were reported.|From the start of study drug administration up to end of follow-up period, assessed up to Day 85|As-treated Population|||Participants|||Number
2571994|NCT02512393|Other Pre-specified|Coping Strategies Questionnaire-Revised Will be Compared Between the Two Groups for a Change Between Baseline and Day 5|This is a questionnaire to assess pain coping strategies, such as distancing from pain, using a 7-point scale that ranges from never do that to always do that. The higher the scale the greater use.|Change from baseline and day 5|||||||
2572001|NCT02512393|Primary|Punctate Mechanical Pain Sensitivity|Quantitative Sensory Testing (QST) by using punctate mechanical pain delivered by a calibrated nylon monofilament.|baseline||||kilopascal (kPa)||Standard Deviation|Mean
2571895|NCT02513459|Secondary|Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) by Visit|The Crohn's Disease Activity Index (CDAI) is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as physical and laboratory findings. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993). A negative change from baseline indicates improvement.|Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184|Observed case (OC) analysis was performed on the intent-to-treat (ITT) analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study.|||units on a scale||Standard Deviation|Mean
2571896|NCT02513459|Secondary|Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Response by Visit|The Inflammatory Bowel Disease Questionnaire (IBDQ) measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). IBDQ response is defined as increase in IBDQ total score >16 points from baseline. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993).|Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192|Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.|||percentage of participants|||Number
2571897|NCT02513459|Secondary|Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission by Visit|The Inflammatory Bowel Disease Questionnaire (IBDQ) measures the effects of inflammatory bowel disease on daily function and quality of life. The IBDQ consists of 32 questions which address symptoms as a result of Crohn's disease: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Each question is answered on a scale from 1 (all the time) to 7 (none of the time); the total score ranges from 32 (worst) to 224 (best). IBDQ remission is defined as IBDQ total score > 170 points.|Weeks 0, 24, 48, 72, 96, 120, 144, 168, and 192|Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.|||percentage of participants|||Number
2571898|NCT02513459|Secondary|Percentage of Participants Achieving Deep Remission by Visit|Deep remission is defined as clinical remission (CDAI < 150) and CDEIS remission (CDEIS score of 4 or less, by visit or for participants with initial isolated ileitis a score of 2 or less).|Weeks 0, 48, 104, 152, and 200|Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.|||percentage of participants|||Number
2571899|NCT02513459|Secondary|Percentage of Participants With Mucosal Healing by Visit|Mucosal healing is defined as Crohn's Disease Endoscopy Index of Severity (CDEIS) ulcerations sub-score (deep ulceration, superficial ulceration, ulcerated stenosis) of 0 as evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The overall CDEIS score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity.|Weeks 0, 48, 104, 152, and 200|Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.|||percentage of participants|||Number
2571900|NCT02513459|Secondary|Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Response by Visit|CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity. Response is defined as a score of 7 or less (or for participants with initial isolated ileitis > 50% reduction from baseline). Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993).|Weeks 0, 48, 104, 152, and 200|Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.|||percentage of participants|||Number
2571901|NCT02513459|Secondary|Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Remission by Visit|CDEIS is an index for determining the severity of Crohn's disease. The CDEIS considers deep ulcerations, superficial ulcerations, ulcerated and non-ulcerated surface, and the presence of ulcerated/non-ulcerated stenosis evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe endoscopic activity. Remission is defined as a score of 4 or less, by visit (or for participants with initial isolated ileitis a score of 2 or less).|Weeks 0, 48, 104, 152, and 200|Observed case (OC) analysis was performed on the intent-to-treat (ITT) SC analysis set, which consisted of all participants who received at least one dose of risankizumab SC in the current study.|||percentage of participants|||Number
2571952|NCT02512861|Secondary|Postoperative Cortisol Levels||12 hours post-surgery||||microgram/deciliter||Inter-Quartile Range|Median
2571953|NCT02512861|Secondary|Postoperative Length of Intubation||5 days post cardiac surgery||||hours||Inter-Quartile Range|Median
2571954|NCT02512861|Primary|Patient-Controlled Analgesia (PCA) Fentanyl/Equivalent Day 0-1||Day of Surgery and Postoperative Day 1||||mcg/kg/day||Inter-Quartile Range|Median
2571955|NCT02512861|Primary|Total Fentanyl/Equivalent Day 0-1||Day of Surgery and Postoperative Day 1||||mcg/kg/day||Inter-Quartile Range|Median
2571902|NCT02513459|Secondary|Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Response by Visit|The PRO-2 is calculated based on the sum of the weighted patient-reported subscores of CDAI for liquid or soft stool frequency [SF] plus abdominal pain [AP] in the 7 days prior to the study visit. The PRO-2 score is calculated by adding the values of the summed stool frequency scores multiplied by 2 plus the summed abdominal pain scores multiplied by 5. The SF and AP score at an assessment visit was the average of the daily values reported during the 7 days preceding the scheduled assessment visit. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease. PRO-2 response is defined as a decrease from baseline of 50 points or more. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993).|Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184|Observed case (OC) analysis was performed on the intent-to-treat (ITT) analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study.|||percentage of participants|||Number
2571903|NCT02513459|Secondary|Percentage of Participants Achieving Patient Reported Outcome 2 (PRO-2) Remission by Visit|The PRO-2 is calculated based on the sum of the weighted patient-reported subscores of CDAI for liquid or soft stool frequency [SF] plus abdominal pain [AP] in the 7 days prior to the study visit. The PRO-2 score is calculated by adding the values of the summed stool frequency scores multiplied by 2 plus the summed abdominal pain scores multiplied by 5. The SF and AP score at an assessment visit was the average of the daily values reported during the 7 days preceding the scheduled assessment visit. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease. Remission is defined as PRO-2 score < 75.|Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184|Observed case (OC) analysis was performed on the intent-to-treat (ITT) analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study.|||percentage of participants|||Number
2571904|NCT02513459|Secondary|Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response by Visit|The Crohn's Disease Activity Index (CDAI) is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as physical and laboratory findings. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical response is defined as CDAI score < 150 or a reduction from baseline of at least 100 points. Baseline is defined as the last measurement prior to the first dose of the study drug in the feeder study NCT02031276 (Boehringer Ingelheim trial 1311.6/AbbVie M15-993).|Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184|Observed case (OC) analysis was performed on the intent-to-treat (ITT) analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study.|||percentage of participants|||Number
2571905|NCT02513459|Secondary|Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission by Visit|The Crohn's Disease Activity Index (CDAI) is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as physical and laboratory findings. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as CDAI score < 150.|Weeks 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, and 184|Observed case (OC) analysis was performed on the intent-to-treat (ITT) analysis sets. The ITT set for IV consisted of all participants who received at least one dose of risankizumab IV in the current study, and the ITT set for SC consisted of all participants who received at least one dose of risankizumab SC in the current study.|||percentage of participants|||Number
2571906|NCT02513459|Primary|Number of Participants With Adverse Events|A treatment emergent adverse event was defined as an event that occurred or worsened on or after the first dose of study drug through 140 days after the last dose in the current study for participants not rolling over into M16-000 Sub-study 3 or until the first dose of study drug in NCT03105102. All treatment-emergent serious and nonserious adverse events were collected, whether elicited or spontaneously reported by the participant.|From the time of study drug administration until 140 days after the last dose of study drug in the current study or until the first dose of study drug in NCT03105102 (AbbVie M16-000 Sub-study 3), up to 4 years for participants who rolled-over|All participants who received at least one dose of risankizumab in the current study|||Participants|||Count of Participants
2571907|NCT02513446|Secondary|Area Under the Curve of BI 1026706 From 0 Extrapolated to Infinity (AUC0-inf)|Area under the concentration-time curve of BI 1026706 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)|-3 hours (h) before drug administration and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration|PKS|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2571908|NCT02513446|Primary|Maximum Concentration of BI 1026706 (Cmax)|Maximum measured concentration of BI 1026706 in plasma (Cmax)|0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration|PKS|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2571909|NCT02513446|Primary|Area Under the Curve of BI 1026706 From 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of BI 1026706 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)|-3 hours (h) before drug administration and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration|Pharmacokinetic set (PKS) included all treated subjects that provided at least 1 primary or secondary pharmacokinetic parameter that was not excluded due to a protocol violation relevant to the evaluation of pharmacokinetics or due to pharmacokinetic non-evaluability..|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2571910|NCT02513160|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly/birth defect, or an important medical event that may not result in death, be life-threatening, or require hospitalization, but may jeopardize the patient and may require medical intervention to prevent one of the outcomes listed in this definition.|Day 0 to Week 6|The safety analysis set included all randomly assigned patients (ITT analysis set) who received at least 1 dose of study drug. In this analysis set, treatment was assigned based on the treatment patients actually received, regardless of the treatment to which they were randomly assigned.|||Participants|||Count of Participants
2571911|NCT02513160|Secondary|Count of Participants Withdrawn From Study Drug Treatment Due to Meeting Stopping Criteria for Worsening Asthma|"Number of participants who were withdrawn from study drug due to worsening asthma. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient's overall clinical picture was consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety. An example of an alert criteria is:~Morning FEV1 by handheld spirometer as measured at home falls below the FEV1 stability limit (FEV1 <80%) as calculated at the screening visit for the Run-in Period and at the randomization visit (Day 0) for the Treatment Period on 4 or more days out of any 7-day period."|Day 0 to Week 6|The modified intent-to-treat (mITT) analysis set included all patients in the ITT analysis set and included the available data for those patients until they discontinued study drug treatment at treatment visit week 6 or last available study visit.|||Participants|||Count of Participants
2571912|NCT02513160|Secondary|Change From Baseline in Weekly Average of Total Daily Asthma Symptom Score Over the 6-Week Treatment Period|Asthma symptom scores were recorded in the patient's diary each morning and evening before determining FEV1 and PEF and before administration of study or rescue medications. The Daytime Symptom Score was recorded in the evening on a scale of 0 (No symptoms during the day) to 5 (Symptoms so severe that I could not go to work or perform normal daily activities) plus the Nighttime Symptom Score in the morning on a scale of 0 (No symptoms during the night) to 4 (Symptoms so severe that I did not sleep at all) for a total score range of 0-9. Baseline was defined as the average of recorded daily asthma symptom scores (average of daytime and nighttime score) over the 7 days prior to the first dose of double-blind study treatment, including the morning assessment at the randomization visit. The LS means, difference of LS means and its 95% CI, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asth|Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks|The modified intent-to-treat (mITT) analysis set included all patients in the ITT analysis set and included the available data for those patients until they discontinued study drug treatment at treatment visit week 6 or last available study visit.|||units on a scale||Standard Error|Least Squares Mean
2571913|NCT02513160|Secondary|Change From Baseline in Weekly Average of Total Daily (24-Hour) Rescue Medication Use Over the 6-Week Treatment Period|Change from baseline in the weekly average of total daily (24-hour) use of albuterol/salbutamol inhalation aerosol over weeks 1 through 6. Patients recorded the number of inhalations (puffs used) of rescue medication (albuterol/salbutamol HFA MDI [90 mcg ex-actuator] or equivalent) each morning and evening in the diary. The average number of daily inhalations over the 7 days before the randomization visit was the baseline value and was compared with the rescue medication use during the 6-week treatment period.|Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks|The modified intent-to-treat (mITT) analysis set included all patients in the ITT analysis set and included the available data for those patients until they discontinued study drug treatment at treatment visit week 6 or last available study visit.|||number of inhalations||Standard Error|Least Squares Mean
2571914|NCT02513160|Secondary|Change From Baseline in Weekly Average of Daily Trough Morning Forced Expiratory Volume in One Minute (FEV1) Rate Over the 6-Week Treatment Period|Change from baseline in the weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) FEV1 by handheld spirometer over the 6-week treatment period. FEV1 were determined twice daily, in the morning and in the evening, before administration of study drug or rescue medications. A handheld spirometer was provided to patients and used to determine the morning and evening FEV1 throughout the study. The spirometer was programmed to record the highest FEV1 obtained from 3 valid attempts. Baseline was defined as the average of recorded trough morning FEV1 assessments over the 7 days prior to the first dose of double-blind study treatment, including the morning assessment at the randomization visit. The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks|The modified intent-to-treat (mITT) analysis set included all patients in the ITT analysis set and included the available data for those patients until they discontinued study drug treatment at treatment visit week 6 or last available study visit.|||milliliters||Standard Error|Least Squares Mean
2571956|NCT02512809|Primary|Change in Serum Cytokine Levels|Surgery subjects will have blood collected once at the start of surgery, once at the end of surgery, and once in the PACU. MRI patients will have blood collected once prior to the start of the MRI and once at the completion of the MRI.|On the day of surgery or MRI from start of procedure to discharge from PACU (approx. 1-7 hrs.)||||pg/ml||Standard Deviation|Mean
2571957|NCT02512783|Secondary|Parental Assessment of Child's Pain on a Visual Analog Scale||Immediately following propofol injection|This data was not collected.||||||
2571995|NCT02512393|Other Pre-specified|Safety Questionnaire Will be Compared Between the Two Groups for a Change Between Baseline, 1, 2, 3, 4, and 5 Days.|This is a questionnaire to assess the presence and severity of adverse events such as headache, tingling, itching, and fatigue, on a scale of 0 to 10, with 0 being not at all and 10 being a highest degree.|Change from baseline, 1, 2, 3, 4, and 5 days|||||||
2571915|NCT02513160|Secondary|Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 6-Week Treatment Period|Change from baseline in the weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF by handheld spirometer over the 6-week treatment period. PEF were determined twice daily, in the morning and in the evening, before administration of study drug or rescue medications. A handheld spirometer was provided to patients and used to determine the morning and evening PEF throughout the study. The spirometer was programmed to record the highest PEF obtained from 3 valid attempts. Baseline was defined as the average of recorded trough morning PEF assessments over the 7 days prior to the first dose of double-blind study treatment, including the morning assessment at the randomization visit. The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction.|Timeframes: Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks|The modified intent-to-treat (mITT) analysis set included all patients in the ITT analysis set and included the available data for those patients until they discontinued study drug treatment at treatment visit week 6 or last available study visit.|||liters/minute||Standard Error|Least Squares Mean
2571916|NCT02513160|Primary|Standardized Baseline-Adjusted Trough Morning Forced Expiratory Volume in One Minute (FEV1) Area Under the Effect Curve From Time Zero to 6 Weeks (AUEC(0-6wk))|The primary efficacy variable was the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) FEV1 AUEC(0-6wk). Pulmonary function measurements such as FEV1 were obtained electronically by spirometry at the randomization visit, each treatment visit (Weeks 2, 4 and 6) and any unscheduled visit (such as the early termination visit). The highest FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 8 attempts) was used. The least-square (LS) means, difference of LS means and its 95% confidence interval (CI), and p-value represent the results obtained from the analysis of covariance with covariate adjustment for baseline, sex, age, current asthma therapy, and treatment.|Baseline (Day 0 of Treatment Period), weeks 2, 4, 6|The modified intent-to-treat (mITT) analysis set included all patients in the ITT analysis set and included the available data for those patients until they discontinued study drug treatment at treatment visit week 6 or last available study visit.|||milliliters||Standard Error|Least Squares Mean
2571917|NCT02513121|Secondary|Change in Triglycerides From Baseline to Week 8||Measurements done at baseline and week 8||||mg/dL||95% Confidence Interval|Mean
2571918|NCT02513121|Secondary|Change in Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) From Baseline to Week 8|HOMA-IR was calculated as follows: fasting insulin (µU/mL) x fasting glucose (nmol/L)/22.5|Measurements done at baseline and week 8||||HOMA score||95% Confidence Interval|Mean
2571919|NCT02513121|Secondary|Change in Insulin From Baseline to Week 8||Measurements done at baseline and week 8||||mg/dL||95% Confidence Interval|Mean
2571920|NCT02513121|Secondary|Change in Gamma-Glutamyl Transpeptidase (GGT) From Baseline to Week 8||Measurements done at baseline and week 8||||U/L||95% Confidence Interval|Mean
2571921|NCT02513121|Secondary|Change in Aspartate Aminotransferase (AST) From Baseline to Week 8||Measurements doen at baseline and week 8||||U/L||95% Confidence Interval|Mean
2571922|NCT02513121|Secondary|Change in Alanine Aminotransferase (ALT) From Baseline to Week 8||Measurements done at baseline and week 8||||U/L||95% Confidence Interval|Mean
2571923|NCT02513121|Primary|Change in Percentage of Liver Fat Measured by Magnetic Resonance Imaging (MRI) in the Intervention Group Compared to Change in the Control Group|The principal objective of this randomized and controlled pilot study is to evaluate whether 8 weeks of a low added sugar diet (<3%) in boys with NAFLD will change liver fat % measured by MRI.|Measurements done at baseline and week 8.||||Percentage of liver fat||95% Confidence Interval|Mean
2571924|NCT02513095|Other Pre-specified|Acute Renal Failure|Acute renal failure as measured by increase in serum creatinine; decrease in urine volume|72 hours|||||||
2571925|NCT02513095|Other Pre-specified|Duration of Hospital Stay|Measure of the length of hospital stay|Up to 72 hours|||||||
2571926|NCT02513095|Other Pre-specified|Lactate Plasma Level|Changes from baseline in systemic lactate level|72 hour duration of study|||||||
2571927|NCT02513095|Secondary|Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13 Over the Course of the Study|Cumulative incidence of subjects who achieve a GCS of ≥ 13 over the course of the study|Study duration|||||||
2571928|NCT02513095|Primary|Cumulative Incidence of Recovery of Level of Consciousness Defined as a Glasgow Coma Scale (GCS) GCS ≥ 13|Cumulative incidence of subjects achieving a GCS ≥ 13 at or prior to 90 minutes post-randomization|90 minutes post-randomization||||Participants|||Count of Participants
2571929|NCT02512900|Secondary|Number of Participants Positive for Anti-drug Antibodies and With Neutralizing Antibodies for MEDI9929 at Any Visit|Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9929. The incidence rate of positive serum antibodies to MEDI9929 were presented.|Days 1 (predose), 29, 57 and 85|As-treated Population. Neutralizing antibody was tested only for the positive ADA samples. Combined immunogenicity data is presented for all participants (that is 12 to 17 years of age). n= Number of participants analyzed for this outcome measure at the given time point.|||Participants|||Number
2571930|NCT02512900|Secondary|Treatment-emergent Adverse Events Related to Electrocardiogram Evaluations|Computerized triplicate 12-lead ECGs as well as Qualitative 12-lead ECGs were obtained during the study. ECG parameters included heart rate, PR, QRS, QT, and corrected QT (QTc) intervals. Number of participants with TEAEs related to ECG after the start of study drug were to be reported.|From the start of study drug administration up to end of follow-up period, assessed up to Day 85|As-treated Population|||Participants|||Number
2571958|NCT02512783|Primary|Change in FLACC (Face, Legs, Activity, Cry, Consolability) Score|The FLACC scale measures pain in children aged 2m-7y. The scale ranges from 0-10 with 0 being no pain. The total score out of 10 is based on 5 pieces of criteria, and each criteria is scored as either 0, 1, or 2. Scores on individual criteria are summed up to give a total score. Higher values represent a worse outcome of more pain. FLACC scores will be compared pre- and post-propofol induction to assess the change in FLACC score for each arm.|1 minute before propofol induction compared to 1 minute following propofol induction||||units on a scale||Standard Deviation|Mean
2571933|NCT02512900|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events|An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is any AE resulting in any of the following outcomes such as death; initial or prolonged inpatient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly or birth defect, or is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. A TEAE is defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0|From the start of study drug administration up to end of follow-up period, assessed up to Day 85|As-treated Population: All participants who received any treatment of MEDI9929.|||Participants|||Number
2571934|NCT02512900|Primary|Apparent Steady-state Volume of Distribution (Vss/F)|The PK parameter Vss/F was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population|||Liter||Standard Deviation|Mean
2571935|NCT02512900|Primary|Apparent Clearance (CL/F)|The PK parameter CL/F was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population|||Liter/day||Standard Deviation|Mean
2571936|NCT02512900|Primary|Terminal Phase Elimination Half Life (t1/2,z)|The t½,z is the time measured for the serum drug concentration of MEDI9929 to decrease by one half. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population|||Day||Standard Deviation|Mean
2571937|NCT02512900|Primary|Time to Reach Cmax (Tmax)|The Tmax is the time to maximum observed serum concentration of MEDI9929. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population|||Day||Full Range|Median
2571938|NCT02512900|Primary|Dose-normalized Cmax (Cmax/D)|The Cmax/D is the maximum observed concentration post dose normalized by MEDI9929 dose. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population|||μg/mL/mg||Standard Deviation|Mean
2571939|NCT02512900|Primary|Maximum Observed Serum Concentration (Cmax)|The PK parameter Cmax was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population|||μg/mL||Standard Deviation|Mean
2571940|NCT02512900|Primary|Dose-normalized AUC (0-infinity) (AUC [0 Infinity]/D)|The AUC (0-infinity)/D is the area under concentration-time curve extrapolated to infinity postdose normalized by MEDI9929 dose. The PK parameter was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population|||μg*day/mL/mg||Standard Deviation|Mean
2571941|NCT02512900|Primary|Area Under the Concentration-Time Curve From Zero to Last Observation (AUC [0-t])|The PK parameter AUC (0-t) was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population|||μg*day/mL||Standard Deviation|Mean
2571942|NCT02512900|Primary|Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity])|The pharmacokinetic (PK) parameter AUC (0 to infinity) was estimated based on the serum concentrations of MEDI9929. Serum concentrations of MEDI9929 were measured by enzyme-linked immunosorbent assay.|Predose on Day 1 and Day 2, 4, 7, 11, 15, 22, 29, 43, 57 and 85 post-dose.|PK Population: All participants who received MEDI9929 and have a sufficient number of serum concentration measurements for computing PK parameters.|||μg*day/mL||Standard Deviation|Mean
2571943|NCT02512874|Secondary|Change in Activity|Energy expenditure- Armband Activity Monitor. Low activity is defined as activity in the lowest 20% -0 <383Kcals/week for men or <270Kcals/week for women.|Six Months|||||||
2571944|NCT02512874|Secondary|Change in Exhaustion|Self-reported exhaustion - measured by the CES-D scale.|Six Months|||||||
2571945|NCT02512874|Secondary|Change in Gait Speed|Fast gait speed test (15 feet). Frailty characterized as slowest 20% by walking time by gender and height.|Six Months|||||||
2571946|NCT02512874|Secondary|Change in Strength|Grip Strength - Dynamometer. Frailty characterized as lowest 20% by gender and body mass index.|Six Months|||||||
2571947|NCT02512874|Secondary|Wasting|Defined as a further decrease in fat free mass by body composition measured by DEXA. Loss of >10 pounds unintentionally.|Six months|||||||
2571948|NCT02512874|Primary|Number of Participants With Frailty Phenotype at Baseline and 6 Months|Frailty phenotype is 3 or more of: slow gait speed, exhaustion, decreased hand grip strength, decreased activity level, or wasting. Grip strength parameters, gait speed, exhaustion per Fried et al. 2001. Wasting is defined as further decrease in fat free mass by body composition measurement using DEXA. Low physical activity would be activity monitor in lower quartile.|Baseline, Six months|Forty-nine participants (77.8%) of the 63 participants completed at lease one follow-up frailty parameter assessment after completion of pulmonary rehabilitation.|||Participants|||Count of Participants
2571949|NCT02512861|Secondary|Postoperative Cortisol Levels||36 hours post-surgery||||microgram/deciliter||Inter-Quartile Range|Median
2571950|NCT02512861|Secondary|Postoperative Pain Scores-State Behavioral Scale (SBS)|State Behavioral Scale (SBS): range is from -3 to 2. A higher score indicates a patient is more uncomfortable and agitated (worse outcome).|Day of Surgery||||score on a scale||Inter-Quartile Range|Median
2571951|NCT02512861|Secondary|Postoperative Pain Scores-Face, Legs, Activity, Cry, Consolability (FLACC) Scale|Face, Legs, Activity, Cry, Consolability (FLACC) scale: range is from 0 to 10 and a higher score indicates greater level of pain (worse outcome).|Day of Surgery||||score on a scale||Inter-Quartile Range|Median
2571960|NCT02512679|Secondary|Number of Participants Who Developed Graft-Versus-Host-Disease (GVHD) as Determined by the Glucksberg Scale|Clinical evaluation on a daily basis during hospitalization and at each post transplant clinical visit, up to one year, to determine incidence of acute and chronic graft-versus-host disease using Glucksberg grading scale. Acute graft-versus-host disease (aGVHD) develops within the first three months after transplantation and appears as a skin rash, often accompanied by hyperbilirubenemia, abnormal liver enzymes and gastrointestinal symptoms, as diarrhea, nausea and vomiting. Level of aGVHD is graded from 1-4. Chronic GVHD, typically a late complication of Blood and Marrow Transplantation (BMT) characterized by skin changes, sometimes sclerotic changes, with joint contractures, liver function abnormality, gastrointestinal symptoms and sometime other organ involvement such as eyes, lungs, and obliterative bronchiolitis (OB). Chronic GVHD is graded as absent, limited, or extensive.|1 yr|Subjects who received dose level 1 of Cyclophosphamide were revaluated for graft-versus-host disease (GVHD) post transplantation.|||participants|||Number
2571961|NCT02512679|Primary|Number of Participants Who Developed Severe Mucositis, Veno-occlusive Disease (VOD), Toxicity of the Kidney, Liver, or Gastrointestinal (GI) Tract up to 1 Year Post-transplant|Assessment of conditioning regimen related toxicity was evaluated and documented with daily assessment during hospitalization and post-transplant follow-up up to one year. None of the subjects developed VOD necessitating any therapeutic intervention, severe mucositis, or toxicity of the Kidney, Liver or Gastrointestinal.|1 year|Subjects who received dose level 1 of Cyclophosphamide did not experience veno-occlusive disease, organ failure or severe mucositis.|||participants|||Number
2571962|NCT02512679|Primary|Number of Participants With Disease Recurrence at 1 Year Post-transplant|"assess rate of disease recurrence (late relapse) due to autologous recovery of recipient hematopoiesis at one year post-HSCT."|1 year|All subjects who received dose level 1 of Cyclophosphamide did not experience re-occurrence of disease.|||participants|||Number
2571963|NCT02512679|Primary|Number of Participants With Neutrophil Engraftment (=/>500 Cells/uL) and Platelet Engraftment (>20K Cell/uL) at 30 Days|Absolute Neutrophil Count (ANC) =/>500;(recovery of white cell count - self sustain platelet above 20,000 per cubic milimeter (20K) - evaluation by Chimerism Study (STR or FISH) at day +30|30 days|Subject enrolled and received Dose Level 1 of Cyclophosphamide and engrafted with Absolute Neutrophil Count (ANC) =/>500;(recovery of white cell count - self sustain platelet above 20k - evaluation by Chimerism Study (STR or FISH) at day +30.|||participants|||Number
2571964|NCT02512575|Secondary|Relative Change From Baseline of AUC0-4h for Serum C-peptide to Assess the Effects on Glucose Homeostasis (Oral Glucose Tolerance Test [OGTT])|"To assess the effect of AZD9567 and prednisolone on OGTT after administration of 75 g glucose solution, blood samples were collected pre glucose intake and at post glucose intake for the analyses of serum C-peptide. AUC0-4h relative change between Day 1 and Day -1 was calculated for each subject in a specific treatment group.~Note: Total AUC0-4h was calculated using the linear trapezoidal method. Statistical analysis for the change in OGTT serum C-peptide total AUC0-4h values were assessed via an analysis of variance (ANCOVA), with treatment as fixed effect."|At Day -1 (baseline) and Day 1 (pre glucose intake and at 30, 60, 90, 120, 150, 180 and 240 minutes post glucose intake)|The PD analysis set consisted of all participants who received a dose of AZD9567/placebo and who had at least one pre-dose and one post-dose measurement for one of plasma glucose, insulin and C-peptide, and who had no major protocol deviations thought to have impacted the analysis of the PD data.|||min*nmol/L||95% Confidence Interval|Geometric Mean
2571965|NCT02512575|Secondary|Relative Change From Baseline of AUC0-4h for Serum Insulin to Assess the Effects on Glucose Homeostasis (Oral Glucose Tolerance Test [OGTT])|"To assess the effect of AZD9567 and prednisolone on OGTT after administration of 75 g glucose solution, blood samples were collected pre glucose intake and at post glucose intake for the analyses of serum insulin. AUC0-4h relative change between Day 1 and Day -1 was calculated for each subject in a specific treatment group.~Note: Total AUC0-4h was calculated using the linear trapezoidal method. Statistical analysis for the change in OGTT serum insulin total AUC0-4h values were assessed via an analysis of variance (ANCOVA), with treatment as fixed effect."|At Day -1 (baseline) and Day 1 (pre glucose intake and at 30, 60, 90, 120, 150, 180 and 240 minutes post glucose intake)|The PD analysis set consisted of all participants who received a dose of AZD9567/placebo and who had at least one pre-dose and one post-dose measurement for one of plasma glucose, insulin and C-peptide, and who had no major protocol deviations thought to have impacted the analysis of the PD data.|||min*pmol/L||95% Confidence Interval|Geometric Mean
2571966|NCT02512575|Secondary|Secondary Outcome: Relative Change From Baseline of AUC0-4h for Plasma Glucose to Assess the Effects on Glucose Homeostasis (Oral Glucose Tolerance Test [OGTT])|"To assess the effect of AZD9567 and prednisolone on OGTT after administration of 75 g glucose solution, blood samples were collected pre glucose intake and at post glucose intake for the analyses of plasma glucose. AUC0-4h relative change between Day 1 and Day -1 was calculated for each subject in a specific treatment group.~Note: Total AUC0-4h was calculated using the linear trapezoidal method. Statistical analysis for the change in OGTT plasma glucose total AUC0-4h values were assessed via an analysis of variance (ANCOVA), with treatment as fixed effect."|At Day -1 (baseline) and Day 1 (pre glucose intake and at 30, 60, 90, 120, 150, 180 and 240 minutes post glucose intake)|The pharmacodynamics (PD) analysis set consisted of all participants who received a dose of AZD9567/placebo and who had at least one pre-dose and one post-dose measurement for one of plasma glucose, insulin and C-peptide, and who had no major protocol deviations thought to have impacted the analysis of the PD data.|||min*mmol/L||95% Confidence Interval|Geometric Mean
2571967|NCT02512575|Primary|Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Area Under the Plasma Concentration-curve From Time Zero Extrapolated to Infinity (AUC)|To assess AUC of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. AUC was estimated by AUC(0-last) + Clast/λz. Clast - the last observed quantifiable concentration.|On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)|The PK analysis set consisted of all participants in the safety analysis set who received a dose of AZD9567 and had at least one of the parameters Cmax, AUC / AUC(0-last) evaluable. All protocol deviations were considered for the severity/impact and were accounted when participants were assigned to the PK analysis sets.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2572002|NCT02512393|Primary|Pressure Pain Threshold|Quantitative Sensory Testing (QST) by using pressure pain delivered by a hand-held algometer.|day 5||||kilopascal (kPa)||Standard Deviation|Mean
2571968|NCT02512575|Primary|Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Area Under the Plasma Concentration-curve From Time Zero to the Time of Last Quantifiable Analyte Concentration (AUC(0-last))|To assess AUC(0-last) of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state.|On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)|The PK analysis set consisted of all participants in the safety analysis set who received a dose of AZD9567 and had at least one of the parameters Cmax, AUC / AUC(0-last) evaluable. All protocol deviations were considered for the severity/impact and were accounted when participants were assigned to the PK analysis sets.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2571969|NCT02512575|Primary|Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Terminal Half-life (t½λz)|To assess t½λz of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. t½λz was estimated as (ln2)/λz.|On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)|The PK analysis set consisted of all participants in the safety analysis set who received a dose of AZD9567 and had at least one of the parameters Cmax, AUC / AUC(0-last) evaluable. All protocol deviations were considered for the severity/impact and were accounted when participants were assigned to the PK analysis sets.|||Hours||Standard Deviation|Mean
2571970|NCT02512575|Primary|Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Time to Reach Maximum Plasma Concentration(Tmax)|To assess the tmax of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. tmax was taken directly from the individual concentration-time curve.|On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)|The PK analysis set consisted of all participants in the safety analysis set who received a dose of AZD9567 and had at least one of the parameters Cmax, AUC / AUC(0-last) evaluable. All protocol deviations were considered for the severity/impact and were accounted when participants were assigned to the PK analysis sets.|||Hours||Full Range|Median
2571971|NCT02512575|Primary|Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Observed Maximum Plasma Concentration (Cmax)|To assess the Cmax of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. Cmax was taken directly from the individual concentration-time curve.|On Day 1 (at pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours post-dose), Day 2 (24 hours post-dose) and Day 3 (48 hours post-dose)|The pharmacokinetic (PK) analysis set consisted of all participants in the safety analysis set who received a dose of AZD9567 and had at least one of the parameters Cmax, AUC / AUC(0-last) evaluable. All protocol deviations were considered for the severity/impact and were accounted when participants were assigned to the PK analysis sets.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2571972|NCT02512575|Primary|Safety and Tolerability of AZD9567 by Assessing the Number of Participants With Adverse Events|"Safety and tolerability variables included AEs, vital signs (blood pressure and pulse), ECGs (12-lead ECGs, safety ECGs and telemetry), clinical laboratory safety evaluations (haematology, clinical chemistry [including osteocalcin], coagulation, urinalysis [including 24 hour urine cortisol per day {tU-cortisol}]) and physical examinations.~Note: No clinically relevant findings were noted in clinical laboratory results and vial signs assessments. Hence, none of the laboratory or vital signs findings were reported as AEs."|At screening, Day -2, Day -1, Day 1 (at pre-dose; 3 & 12 hours post-dose), Day 2 (24 hours post-dose), Day 3 and follow-up (7 to 10 days post-dose)|All participants who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study. IMP includes AZD9567, Prednisolone 60 mg and placebo.|||Participants|||Number
2571973|NCT02512510|Secondary|Percentage of Albuterol Rescue-free 24-hour Periods||1-3 Months||||Percentage of 24hr periods||Standard Error|Least Squares Mean
2571974|NCT02512510|Secondary|St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85|A Responder is defined as someone who experienced a decrease in SGRQ score of 4 or more units|Day 85||||Participants|||Count of Participants
2571975|NCT02512510|Secondary|Summary of Rescue Medication Use: Puffs Per Day||1-3 Months||||Puffs per Day||Standard Error|Least Squares Mean
2571976|NCT02512510|Secondary|Summary of Change From Baseline to Peak FEV1 After First Dose||0-2 hours after First Dose Day 1||||mL||Standard Error|Least Squares Mean
2571977|NCT02512510|Secondary|Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85||Days 15 to 85||||mL||Standard Error|Mean
2571978|NCT02512510|Primary|Change From Baseline in Trough FEV1 on Day 85||Baseline and Day 85|Intent-to-treat (ITT) analysis set|||mL||Standard Error|Least Squares Mean
2571979|NCT02512419|Primary|Self Reported Min/Week of MVPA|Self reported physical activity (collected via 7 day PAR)|baseline and 6 months||||min/week||Inter-Quartile Range|Median
2571980|NCT02512419|Primary|Objectively Measured Physical Activity of at Least Moderate Intensity (MVPA) by the Actigraph GT3X+|Participants will wear an Actigraph GT3X+ accelerometer, which measures movement and intensity of activity and has been validated against heart rate telemetry and total energy expenditure.|Baseline and 6 months||||minutes/week||Inter-Quartile Range|Median
2571981|NCT02512393|Secondary|Interleukin 10 (IL-10) Level||day 5||||pg/mL||Standard Deviation|Mean
2571982|NCT02512393|Secondary|Interleukin 10 (IL-10) Level||baseline||||pg/mL||Standard Deviation|Mean
2571983|NCT02512393|Secondary|Interleukin 6 (IL-6) Level||day 5||||pg/mL||Standard Deviation|Mean
2571984|NCT02512393|Secondary|Interleukin 6 (IL-6) Level||baseline||||pg/mL||Standard Deviation|Mean
2571985|NCT02512393|Secondary|Tumor Necrosis Factor (TNF) Level||day 5||||pg/mL||Standard Deviation|Mean
2571986|NCT02512393|Secondary|Tumor Necrosis Factor (TNF) Level||baseline||||pg/mL||Standard Deviation|Mean
2571987|NCT02512393|Secondary|C-reactive Protein (CRP) Level||day 5||||ng/mL||Standard Deviation|Mean
2571988|NCT02512393|Secondary|C-reactive Protein (CRP) Level||baseline||||ng/mL||Standard Deviation|Mean
2571989|NCT02512393|Secondary|Cortisol Level||day 5||||pg/mL||Standard Deviation|Mean
2571990|NCT02512393|Secondary|Cortisol Level||baseline||||pg/mL||Standard Deviation|Mean
2572008|NCT02512393|Primary|Short Physical Performance Battery (SPPB)|This is a group of measures that combines the results of the gait speed, chair stand, and balance tests. The score ranges from 0 (worst performance) to 12 (best performance).|day 5||||units on a scale||Standard Deviation|Mean
2572009|NCT02512393|Primary|Short Physical Performance Battery (SPPB)|This is a group of measures that combines the results of the gait speed, chair stand, and balance tests. The score ranges from 0 (worst performance) to 12 (best performance).|baseline||||units on a scale||Standard Deviation|Mean
2572010|NCT02512393|Primary|Six-minute Walk Test|The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The lower the score the worse the condition.|day 5||||meters||Standard Deviation|Mean
2572011|NCT02512393|Primary|Six-minute Walk Test|The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The lower the score the worse the condition.|baseline||||meters||Standard Deviation|Mean
2572012|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|day 5||||units on a scale||Standard Deviation|Mean
2572013|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Affective Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|baseline||||units on a scale||Standard Deviation|Mean
2572014|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|day 5||||units on a scale||Standard Deviation|Mean
2572015|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Neuropathic Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|baseline||||units on a scale||Standard Deviation|Mean
2572016|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale|This is a index to rate the activity of pain based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme. The higher the score, the worse the pain.|day 5||||units on a scale||Standard Deviation|Mean
2572017|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Intermittent Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|baseline||||units on a scale||Standard Deviation|Mean
2572018|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|day 5||||units on a scale||Standard Deviation|Mean
2572019|NCT02512393|Primary|Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) Continuous Pain Subscale|This is a questionnaire to rate the pain intensity and related symptoms on a scale of 0 to 10, with 0 being none and 10 being the worst possible. The higher the score the worse the pain.|baseline||||units on a scale||Standard Deviation|Mean
2572020|NCT02512393|Primary|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale|This is a index to rate the activity of pain, stiffness, and physical function based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme; subscales are added up for a summation score. The higher the score, the worse the pain.|day 5||||units on a scale||Standard Deviation|Mean
2572021|NCT02512393|Primary|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale|This is a index to rate the activity of pain, stiffness, and physical function based on a scale of difficulty: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme; subscales are added up for a summation score. The higher the score, the worse the pain.|baseline||||units on a scale||Standard Deviation|Mean
2572022|NCT02512393|Primary|Numeric Rating Scale (NRS) for Pain|Numeric Rating Scale for pain is an 101-point scale for patient self-reporting of pain on a scale of 0 to 100, with 0 being no pain at all and 100 being the worst pain imaginable. The higher the score the worse the pain.|day 5||||units on a scale||Standard Deviation|Mean
2572023|NCT02512393|Primary|Numeric Rating Scale (NRS) for Pain|Numeric Rating Scale for pain is an 101-point scale for patient self-reporting of pain on a scale of 0 to 100, with 0 being no pain at all and 100 being the worst pain imaginable. The higher the score the worse the pain.|baseline||||units on a scale||Standard Deviation|Mean
2572024|NCT02512302|Secondary|The Percentage of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation|An adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.|Up to Week 5|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||percentage of participants|||Number
2572025|NCT02512302|Secondary|The Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation|An adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.|Up to Week 5|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||participants|||Number
2572037|NCT02512302|Secondary|Volume of Distribution During the Elimination Phase (Vz) for IV Infusion of 50 mcg of Glycopyrrolate|calculated as Dose/(AUC0-inf*λz). Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.|Up to Week 5|The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2572026|NCT02512302|Secondary|Dose Normalized Area Under the Curve Zero From Zero to Infinity (AUC0_inf) for Seebri and SUN-101|"Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.~Area under the drug concentration-time curve from zero to infinity, calculated by summing AUC0-last and the AUC extrapolated from tlast to infinity multiplied by the dose normalization factor: dose normalization factor* (AUC0-∞ = AUC0-last+ Clast / | λz | ) Clast / | λz | is the extrapolated area under the curve from tlast to infinity. If this quantity is greater than 20% of AUC0-∞, then AUC0-∞ was considered to be missing.~The dose normalization factor calculation has two components: dose equivalent glycopyrrolate amount and the delivery efficiency (% dose delivered). For Sun-101 50mcg , the dose normalization factor is 1.59, for Seebri Breezhaler it is 0.9."|up to week 5|The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.|||hr*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2572027|NCT02512302|Secondary|Dose Normalized Area Under the Curve Zero to 48 Hours (AUC0_48) for Seebri and SUN-101|"Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.~Area under the drug concentration-time curve from time zero to 48 hours postdose multiplied by the dose normalization factor. The dose normalization factor calculation has two components: dose equivalent glycopyrrolate amount and the delivery efficiency (% dose delivered). For Sun-101 50 mcg, the dose normalization factor is 1.59, for Seebri Breezhaler it is 0.9."|up to week 5|The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.|||hr*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2572028|NCT02512302|Secondary|Dose Normalized Area Under the Curve Zero to 24 Hours (AUC0_24) for Seebri and SUN-101|"Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.~Area under the drug concentration-time curve from time zero to 24 hours postdose multiplied by the dose normalization factor. The dose normalization factor calculation has two components: dose equivalent glycopyrrolate amount and the delivery efficiency (% dose delivered). For Sun-101 50 mcg, the dose normalization factor is 1.59, for Seebri Breezhaler it is 0.9."|up to week 5|The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.|||hr*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2572029|NCT02512302|Secondary|Dose Normalized Cmax for Seebri and SUN-101.|"Maximum observed concentration multiplied by the dose normalization factor. Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.~The dose normalization factor calculation has two components: dose equivalent glycopyrrolate amount and the delivery efficiency (% dose delivered). For Sun-101 50 mcg, the dose normalization factor is 1.59, for Seebri Breezhaler it is 0.9."|up to week 5|The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.|||Pg/mL||Geometric Coefficient of Variation|Geometric Mean
2572030|NCT02512302|Secondary|Terminal Half Life (t1/2) for for Seebri Breezhaler and SUN-101|"calculated as ln(2) / λz . At least 3 data points at the terminal elimination phase were required to determine t½.~Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr."|up to week 5|The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.|||hr||Geometric Coefficient of Variation|Geometric Mean
2572031|NCT02512302|Secondary|Time of Occurrence of Cmax (Tmax) for Seebri Breezhaler and SUN-101|The time 0 is based on start of the inhalation. Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.|up to week 5|The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.|||hr||Full Range|Median
2572032|NCT02512302|Secondary|Apparent Volume of Distribution (Vz/F) After Extravascular Dose Administration of Seebri Breezhaler and SUN-101|"calculated as Dose/(AUC0-∞* λz), where F = Bioavailability. If AUC0-∞ is missing, then Vz/F is considered as missing.~Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr"|up to week 5|The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.|||liters||Geometric Coefficient of Variation|Geometric Mean
2572033|NCT02512302|Secondary|Apparent Clearance Calculated as Dose/AUC0-INF After Extravascular Dose Administration of Seebri Breezhaler and SUN-101|"calculated as Dose/AUC0-∞ after extravascular dose administration, where F = Bioavailability. If AUC0-∞ is missing, then CL/F is considered as missing.~Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr."|up to week 5|The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2572034|NCT02512302|Secondary|Area Under the Curve Zero to 48 Hours (AUC0_48) for Seebri Breezhaler and Sun-101 AUC0-48, CL/F, Vz/F, Tmax, t½, and Dose Normalized Cmax, AUC0-24, AUC0-48, AUC0-∞ - AUC0-∞ -|Area under the drug concentration-time curve from time zero to 48 hours postdose Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.|Up to Week 5|The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.|||hr*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2572035|NCT02512302|Secondary|Terminal Half Life (t1/2) for IV Infusion of 50 mcg of Glycopyrrolate|"calculated as ln(2) / λz . At least 3 data points at the terminal elimination phase were required to determine t½.~Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr."|Up to Week 5|The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.|||hr||Geometric Coefficient of Variation|Geometric Mean
2572036|NCT02512302|Secondary|Time of Occurrence of Cmax (Tmax) for IV Infusion of 50 mcg of Glycopyrrolate|The time 0 is based on start of the infusion. Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr.|Up to Week 5|The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.|||hr||Full Range|Median
2572071|NCT02511717|Secondary|Overactive Bladder Questionnaire Short Form (OAB-q SF)|OAB quality of life questionnaire|12 weeks|||||||
2572038|NCT02512302|Secondary|Clearance (CL) for IV Infusion of 50 mcg of Glycopyrrolate|"calculated as Dose/AUC0-inf after the IV dose administration. If AUC0-inf is missing, then CL was considered as missing.~Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr."|Up to Week 5|The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.|||Liters/hr||Geometric Coefficient of Variation|Geometric Mean
2572039|NCT02512302|Primary|Area Under the Curve From Time Zero to Infinity (AUC0_infinity)|"calculated by summing AUC0-last and the AUC extrapolated from tlast to infinity: AUC0-∞ = AUC0-last+ Clast / | λz | Clast / | λz | is the extrapolated area under the curve from tlast to infinity. If this quantity is greater than 20% of AUC0-∞, then AUC0-∞ was considered to be missing.~Pk parameters are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr."|Up to Week 5|The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication, and have any evaluable PK data.|||hr*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2572040|NCT02512302|Primary|Area Under the Curve From Time Zero to 24 Hours (AUC0_24)|Area under the drug concentration-time curve from time zero to 24 hours postdose pk parameteres are calculated from plasma concentration analyzed from blood samples collected between 0 and 48 hr|Up to Week 5|The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication and have any evaluable PK data|||hr*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2572041|NCT02512302|Primary|Cmax|maximum observed concentration-Cmax is calculated from plasma concentrations analyzed from blood samples collected between 0 and 48 hr.|Up to Week 5|The Pharmacokinetic (PK) population consists of all subjects who were randomized, received study medication and have any evaluable PK data|||Pg/mL||Geometric Coefficient of Variation|Geometric Mean
2572042|NCT02512276|Secondary|Healthcare Utilization - Hospitalizations|Number of patients with at least 1 hospitalization.|12 months||||Participants|||Count of Participants
2572043|NCT02512276|Secondary|Healthcare Utilization - Office Visits|Number of patients with at least 1 office visit.|12 months||||Participants|||Count of Participants
2572044|NCT02512276|Secondary|Healthcare Utilization - ER Visits|Number of patients with at least 1 ER visit.|12 months|Intention to treat|||Participants|||Count of Participants
2572045|NCT02512276|Secondary|Disease Control|"Percentage of patients achieving good disease control for at least one eligible condition.~Disease control was evaluated using laboratory or blood pressure values in the electronic health record and was based on clinical guideline targets (HbA1c values for patients with diabetes, systolic and diastolic blood pressure for patients with hypertension, and LDL values for patients with hyperlipidemia).~This outcome measure disease control was measured as the proportion of patients achieving good disease control based on guideline-specified targets for all at least 1 eligible condition, as opposed to all of their eligible conditions for Outcome Measure 2. An eligible condition is a diagnosis of either hyperlipidemia, hypertension, or diabetes and evidence of poor control for that condition at the time of enrollment."|12 months|Intention to treat|||percentage of participants|||Number
2572046|NCT02512276|Secondary|Disease Control - All Eligible Conditions|"Percentage of patients achieving good disease control for all eligible conditions.~Disease control was evaluated using laboratory or blood pressure values in the electronic health record and was based on clinical guideline targets (HbA1c values for patients with diabetes, systolic and diastolic blood pressure for patients with hypertension, and LDL values for patients with hyperlipidemia).~This outcome measure disease control was measured as the proportion of patients achieving good disease control based on guideline-specified targets for all of their eligible conditions, as opposed to at least 1 for Outcome Measure 3. An eligible condition is a diagnosis of either hyperlipidemia, hypertension, or diabetes and evidence of poor control for that condition at the time of enrollment."|12 months|Intention to treat|||percentage of participants|||Number
2572047|NCT02512276|Primary|Medication Adherence|"Average proportion of days covered (PDC) for medications to treat eligible conditions. An eligible condition is a diagnosis of either hyperlipidemia, hypertension, or diabetes and evidence of poor control for that condition at the time of enrollment. Adherence will be measured as an average of averages PDC only for medications that qualified a patient for inclusion in the study.~Medication adherence is often reported as percentage of days covered."|12 months|Intention to treat|||percentage of days covered||Standard Deviation|Mean
2572048|NCT02512224|Secondary|Mortality Calculated From Outcome Section From DPC Database at 30 Days||30 days after the start of the procedure||||participants|||Number
2572049|NCT02512224|Secondary|Mortality Calculated From Outcome Section From DPC Database at 14 Days||14 days after the start of the procedure||||Participants|||Number
2572050|NCT02512224|Secondary|Re-admission 30 Days||re-admission within 30 days of discharge.||||Participants|||Number
2572051|NCT02512224|Secondary|Post-procedural Sepsis||the incidence of post-procedural sepsis occurring during hospitalization. Participants will be followed for the duration of hospital stay, an expected median of 3 weeks after procedure.||||Participants|||Number
2572052|NCT02512224|Secondary|Post-procedural Pneumonia||the incidence of post-procedural pneumonia occurring during hospitalization. Participants will be followed for the duration of hospital stay, an expected median of 3 weeks after procedure.||||Participants|||Number
2572053|NCT02512224|Primary|Mortality Calculated From Outcome Section From DPC Database at 90 Days||90 days after the start of the procedure||||Participants|||Number
2572054|NCT02512094|Primary|Score of the Barthel Index|"Score of the Barthel Index ranging from 0 to 100 were collected when 0 is the minimum (worst outcome) and 100 is the maximum (best outcome).~Score was reported as mean score of the Barthel Index."|up to 1 month|All patients were analyzed using descriptive statistics.|||units on a scale||Standard Deviation|Mean
2572055|NCT02512068|Secondary|Number of Participants With Markedly Abnormal Values of Clinical Laboratory Parameters Before the Start of Study Drug Administration in Treatment Period II|"Here U/L is Unit/Litter, and ULN is Upper Limit of Normal."|Up to Week 12|Safety Analysis Set: The safety analysis set was defined as all participants who received at least one dose of the study drug.|||Participants|||Count of Participants
2572957|NCT02500368|Secondary|Conjunctival Staining|Conjunctival Staining 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4; 0.5 steps, 0=None,1=Minimal diffuse punctuate, 2=Coalescent punctuate, 3=Confluent, 4=Deep confluent|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2572056|NCT02512068|Secondary|Number of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters Before the Start of Study Drug Administration in Treatment Period II|"Here QTcF is corrected QT interval by Fridericia formula."|Up to Week 12|Safety Analysis Set: The safety analysis set was defined as all participants who received at least one dose of the study drug. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at the given time point.|||Participants|||Count of Participants
2572057|NCT02512068|Secondary|Numbers of Participants With TEAE Related to Vital Signs Before the Start of Study Drug Administration in Treatment Period II|"Number of participants with a vital sign-related TEAE classified under the System Organ Class of investigations, was reported."|Up to Week 12|Safety Analysis Set: The safety analysis set was defined as all participants who received at least one dose of the study drug.|||Participants|||Count of Participants
2572058|NCT02512068|Secondary|Change From Baseline in Glycoalbumin|Reported data was the change from baseline in glycoalbumin at each time point.|Baseline (Week 0) and Week 2, 4, 8, 12, and End of Treatment Period I (up to Week 12) and Period II (up to Week 52)|Full Analysis Set: All randomized participants who received at least one dose of study drug. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at the given time point.|||Percent||Standard Deviation|Mean
2572059|NCT02512068|Secondary|Change From Baseline in Fasting Plasma Glucose|Reported data was the change from baseline in fasting plasma glucose at each time point.|Baseline (Week 0) and Week 2, 4, 8, 12, and End of Treatment Period I (up to Week 12) and Period II (up to Week 52)|Full Analysis Set: All randomized participants who received at least one dose of study drug. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at the given time point.|||mg/dL||Standard Deviation|Mean
2572060|NCT02512068|Secondary|Number of Participants Achieving <6.0%, <7.0%, and <8.0% HbA1c at the End of Treatment Period I and Period II||At the end of Treatment Period I (Up to Week 12) and Period II (Up to Week 52)|Full Analysis Set: All randomized participants who received at least one dose of study drug. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at the given time point.|||Participants|||Count of Participants
2572061|NCT02512068|Secondary|Changes From Baseline in HbA1c|Reported data was the change from baseline in HbA1c at each time point.|Baseline (Week 0) and Week 2, 4, 8, 12, and End of Treatment Period I (up to Week 12) and Period II (up to Week 52)|Full Analysis Set: All randomized participants who received at least one dose of study drug. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at the given time point.|||Percent HbA1c||Standard Deviation|Mean
2572062|NCT02512068|Primary|Number of Participants Who Had One or More TEAE Occurred After 1st Dose of Trelagliptin 25 mg Tablet|"An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a drug (including the study drug). It does not necessarily have to have a causal relationship with this treatment (including the study drug). An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug (including the study drug), whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. As to collect the safety data of long-term treatment with the active drug widely, the number of participants reporting one or more TEAEs that occurred after 1st dose of trelagliptin 25 mg, that is events in Period I and II for Trelagliptin 25 mg group and events in Period II for Placebo and Trelagliptin 25 mg group, was analyzed."|Up to Week 54|Safety Analysis Set: The safety analysis set was defined as all participants who received at least one dose of the study drug. Number analyzed is the number of participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2572063|NCT02512068|Primary|Number of Participants Who Had One or More Treatment Emergent Adverse Event (TEAE) Before the Start of Study Drug Administration in Treatment Period II|An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a drug (including the study drug). It does not necessarily have to have a causal relationship with this treatment (including the study drug). An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug (including the study drug), whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Reported data is the number of participants reporting one or more TEAEs that occurred before the start of Treatment Period II in each group.|Up to Week 12|Safety Analysis Set: The safety analysis set was defined as all participants who received at least one dose of the study drug.|||Participants|||Count of Participants
2572064|NCT02512068|Primary|Change From Baseline in HbA1c at the End of Treatment Period I||Baseline (Week 0) and end of Treatment Period I (Up to Week 12)|Full Analysis Set: All randomized participants who received at least one dose of study drug.|||Percent HbA1c||Standard Error|Least Squares Mean
2572065|NCT02512042|Primary|Mean Difference in Intraocular Pressure (IOP) of Both Eyes Between the Two Treatment Groups at Four Time Points|The primary efficacy end point is the mean difference in intraocular pressure (IOP) of both eyes between the two treatment groups at four time points, i.e., at approximately 8:00 am (hour 0; before the morning drop) and 10:00 am (hour 2; after the morning drop) at the Day 14 (week 2) and Day 42 (week 6) visits|Day 14 and 42 at 8AM and 10AM|Participants in Per Protocol Population who met inclusion/exclusion criteria, instilled a pre-specified proportion of the scheduled doses for the specified duration of the study, who did not miss scheduled applications for more than 3 days, and completed evaluations at Day 14 and Day 42 within the visit window.|||mmHg||Standard Deviation|Mean
2572066|NCT02511782|Primary|CXCL10 in Plasma|Plasma was used to assess CXCL10 levels from blood.|At time of GVHD diagnosis.|We did not analyze the plasma collected from patients with chronic skin GVHD; therefore, there is no data to report. We did not analyze all acute GVHD samples for financial reasons.|||Plasma CXCL10 picograms/microliters||Standard Error|Mean
2572067|NCT02511782|Primary|CXCL10 in Skin|D-sqaume epidermal discs were used to assess CXCL10 levels from skin.|At time of GVHD diagnosis.|We did not analyze all acute GVHD samples for financial reasons.|||Skin CXCL10 femtograms/micrograms||Standard Error|Mean
2572068|NCT02511717|Secondary|Physician Assessment of Treatment Benefit||12 weeks|||||||
2572069|NCT02511717|Secondary|24hr Pad Weights||12 weeks|||||||
2572070|NCT02511717|Secondary|Voiding Diary||12 weeks|||||||
2572072|NCT02511717|Primary|Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question)|Patient percention of bladder condition (PPBC) question. It is scored from 0 (My bladder condition does not cause me any problems at all) to 5 (My bladder condition causes me many severe problems). Higher numbers are worse outcomes.|12 weeks||||units on a scale||Inter-Quartile Range|Median
2572073|NCT02511678|Other Pre-specified|Number of Participants With Intra- or Post-operative Adverse Events, a Serious Adverse Event, or Unanticipated Adverse Device Effects Prior to Week 8|The number of participants with an intra-operative non-serious adverse event, a post-operative, a non-serious adverse event, a serious adverse event, or unanticipated adverse device effects related to the cryoablation procedure is presented. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Up to Week 8|Participants for whom received the complete study cryoablation procedure (Safety Population).|||Participants|||Count of Participants
2572074|NCT02511678|Other Pre-specified|Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24|"Participants performed a self-assessment of OTE at Week 1 and every visit thereafter (Weeks 4, 8, 12, 16, 20 and 24). Participants were asked their opinion of the effect cryoablation procedure had on their wellbeing and asked to compare their wellbeing at the time of each follow-up visit to the previous visit or phone call. The wellbeing categories were Better than the Last Visit, The Same as the Last Visit, and Worse than the Last Visit. The percentage of participants that were reported for each wellbeing category at Weeks 1, 4, 8, 12, 16, 20, and 24 is presented."|Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable OTE data.|||percentage of participants|||Number
2572075|NCT02511678|Other Pre-specified|Change From Baseline in Average Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 8, 12, 16, 20, and 24|The BPI-SF is a validated instrument used widely in clinical research to assess cancer pain. Assessments were of self-reported average pain scores in the last 24 hours in the target lesion treated with study cryoablation on a scale from 0 (no pain) to 10 (worst pain imaginable) using the BPI-SF. Baseline data and change from Baseline data is presented.|Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable average pain scores.|||score on a scale||Standard Deviation|Mean
2572076|NCT02511678|Other Pre-specified|Change From Baseline in Worst Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 12, 16, 20, and 24|The BPI-SF is a validated instrument used widely in clinical research to assess cancer pain. Assessments were of self-reported worst pain scores in the last 24 hours in the target lesion treated with study cryoablation on a scale from 0 (no pain) to 10 (worst pain imaginable) using the BPI-SF. Improvement in self-reported pain scores is defined by ≥2-point reduction in worst pain. A mean difference of a 2 point reduction is considered clinically significant, that is improvement. Baseline data and change from Baseline data at Weeks 1, 4, 12, 16, 20, and 24 is presented.|Baseline, Week 1, Week 4, Week 12, Week 16, Week 20, and Week 24|Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable worse pain scores.|||score on a scale||Standard Deviation|Mean
2572077|NCT02511678|Other Pre-specified|Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24|Analgesic (that is, opioid or non-steroidal anti-inflammatory drug [NSAID]) use and the reason for each change in analgesic dose was recorded at each study visit. Opioid medications were converted to a standardized MEDD. MEDD is calculated using the following formula: [Dose]*[MEDD Factor]. MEDD Factor is based on the type and dose of the opioid received. Baseline data and change from Baseline data is presented.|Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable MEDD and NSAID data.|||milligrams (mg)||Standard Deviation|Mean
2572078|NCT02511678|Other Pre-specified|Number of Participants With Additional Pain Therapies|Participants requiring additional targeted therapies to the index tumor (for example, cryoablation, radio frequency ablation [RFA], microwave ablation [MWA], high intensity focused ultrasound [HIFU], radiation, surgery) were withdrawn from the study. Other therapies, including pain medication and chemotherapy, were permitted during the study. All additional therapies were recorded. The number of participants requiring new therapy since the last visit is presented.|Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable additional pain therapy data.|||Participants|||Count of Participants
2572079|NCT02511678|Other Pre-specified|Change From Baseline in Physical Function as Assessed by the KPS Scale at Weeks 1, 4, 8, 12, 16, 20, and 24|The Karnofsky Performance Status (KPS) scale is a standard way of measuring the ability of cancer participants to perform ordinary tasks. KPS may be used to determine a participant's prognosis and to measure changes in a participant's ability to function. Assessments made by examining the change in the baseline scores to those reported post-operatively. KPS scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities from Baseline to 1, 4, 8, 12, 16, 20, and 24 weeks after cryoablation. Baseline data and change from Baseline data is presented.|Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable KPS scores.|||units on a scale||Standard Deviation|Mean
2572080|NCT02511678|Other Pre-specified|Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24.|Quality of Life (QoL) as indicated by the change in overall average BPI-SF Pain Interference score from baseline to each visit was evaluated at Weeks 1, 4, 8, 12, 16, 20, and 24. Using the BPI-SF, participants rated the amount of interference from pain on a scale of 0 (does not interfere) to 10 (completely interferes) for the following areas: general activity. mood, walking ability, relations, sleep, and enjoyment. For participants with responses ≥50% of the areas at a time point, a total Pain Interference score, which was the mean of the individual area scores, was calculated programmatically at that point. Baseline data and change from Baseline data is presented.|Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable interference from pain scores.|||score on a scale||Standard Deviation|Mean
2572081|NCT02511678|Other Pre-specified|Percentage of Participants Who Respond to the Cryoablation Therapy|Response was defined as a ≥2-point reduction from baseline in worst pain in last 24 hours with stable medication use (that is, no more than a 25% increase in Morphine Equivalent Daily Dose [MEDD] from baseline). MEDD is calculated using the following formula: [Dose]*[MEDD Factor]. MEDD Factor is based on the type and dose of the opioid received. Pain was assessed using BPI-SF with a scale of 0 (no pain) to 10 (worst pain imaginable). Percentages are proportion of responders based on logistic regression after MCMC, multiple imputation. For visits where medication use is not available, morphine equivalent values from the most recent non-missing visit are used.|Baseline and Week 8|Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population).|||percentage of participants||95% Confidence Interval|Number
2572082|NCT02511678|Primary|Change From Baseline in Worst Pain Scores as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) at Week 8|The BPI-SF is a validated instrument used widely in clinical research to assess cancer pain. Assessments were of self-reported worst pain scores in the last 24 hours in the target lesion treated with study cryoablation on a scale from 0 (no pain) to 10 (worst pain imaginable) using the BPI-SF. Improvement in self-reported pain scores is defined by ≥2-point reduction in worst pain. A mean difference of a 2-point reduction is considered clinically significant, that is improvement. Baseline data and change from Baseline data at Week 8 is presented.|Baseline, Week 8|Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population). The Markov chain Monte Carlo (MCMC) method of imputation was used for imputation of missing BPI-SF values with 50 imputations to be performed.|||score on a scale||Standard Error|Mean
2572083|NCT02511587|Secondary|TBE Titer Profile|TBE specific neutralizing antibody titer profiles (geometric mean titers, GMT)|before (day 0) and 1week, 1 month, 6 months after booster vaccination||||Geometric mean titers||95% Confidence Interval|Geometric Mean
2572084|NCT02511587|Secondary|Cellular Immune Responses - Cytokines|cytokine production of antigen-specifically restimulated PMBC (peripheral blood mononuclear cells) is evaluated (Interleukin 2, Interleukin 10, Interferon gamma)|before (day 0) and 1 week after booster vaccination||||pg/ml||Standard Deviation|Mean
2572085|NCT02511587|Primary|Humoral Immunity to TBE (Tick-borne Encephalitis) Vaccine|GMT (geometric mean titers) of TBE Neutralisation test titers one month after booster vaccination|1 month||||Geometric mean titers||95% Confidence Interval|Geometric Mean
2572086|NCT02511535|Secondary|TBE Titer Course|Fold Change in TBE Specific Neutralizing Antibodies from day 0 (before booster) and one week, one month and 6 months after booster vaccination|before (day 0) until 6 months after booster vaccination||||fold change from d0 (before booster)||95% Confidence Interval|Mean
2572087|NCT02511535|Secondary|Cellular Immune Response - Lymphocyte Subpopulations|analyses of naive, memory and regulatory sub-populations of B- and T-lymphocytes|before (day 0) and 1week after booster vaccination||||percent of total lymphocytes||95% Confidence Interval|Mean
2572088|NCT02511535|Secondary|Cellular Immune Response - Cytokine Production|cytokine production of antigen-specifically re-stimulated PMBC, IL-2 (interleukin 2) IFN g (interferon gamma) IL-10 (interleukin 10) IL-5 (interleukin 5)|before (day 0) and 1week after booster vaccination|the missing cytokine concentrations were not used for calculation because of invalid positive controls (due to poor PBMC [peripheral blood mononuclear cell] viability)|||pg/ml||95% Confidence Interval|Geometric Mean
2572089|NCT02511535|Primary|Humoral TBE Immunity|Geometric mean titers of TBE specific neutralizing Abs|one month after booster vaccination||||titer||95% Confidence Interval|Geometric Mean
2572090|NCT02511431|Primary|Number of Participants With Decline of HDV RNA Quantitative Measurement of > 2 Logs From Baseline at 24 Weeks of Treatment|The number of participants who experienced a > 2 log IU/mL decline in serum HDV RNA levels at 24 weeks of treatment|24 weeks|This outcome is for decline in serum HDV RNA levels over 24 weeks of treatment. Arms 4, 5 and 6 had only 12 weeks of treatment and so are not included in this analysis.|||Participants|||Count of Participants
2572091|NCT02511431|Primary|Number of Participants With Decline of Hepatitis Delta Virus (HDV) RNA Quantitative Measurements of >2 Logs From Baseline at 12 Weeks of Treatment|The number of participants who experienced a > 2 log IU/mL decline in serum HDV RNA at 12 weeks of treatment|12 weeks||||Participants|||Count of Participants
2572092|NCT02511379|Primary|Change From Baseline in Corneal Staining Total Score|The type (severity) of staining was assessed for each of the 5 regions of the cornea (central, inferior, temporal, superior, and nasal) and graded on a 4-point scale, where 0 = Normal (No staining) and 3 = Severe (Numerous coalescent macropunctate areas and/or patches). The scores of the 5 regions were summed to obtain a corneal staining total score for each eye (minimum 0, maximum 15).|Baseline (Day 0), Day 45, Day 90|Analysis includes all participants with data present. Analysis was based on the eye with the higher corneal staining total score at screening or the right eye when both eyes have same corneal staining total score at screening, as observed.|||units on a scale||Full Range|Mean
2572093|NCT02511184|Secondary|Number of Participants With Programmed Death Receptor-1 Ligand-1 (PD-L1) Expression Level Meeting Pre-defined Criteria|Archived formalin-fixed, paraffin-embedded tumor issue block was collected at screening. PD-L1 assessment was performed using immunohistochemistry. A sample was considered negative if tumor proportion score was less than 1%; positive if tumor proportion score was greater than or equal to 1%; strong positive if tumor proportion score was greater than or equal to 50%.|Screening|The analysis population included all participants who had evaluable PD-L1 measurements.|||Participants|||Count of Participants
2572094|NCT02511184|Secondary|Serum Concentration of Pembrolizumab||Prior to and at end of pembrolizumab infusion, 120 hours and 336 hours post Day 1 dosing of Cycle 1; pre-dose on Day 1 of Cycles 2, 4,6, 8, 12 and 16; end of Day 1 dosing of Cycle 8; End of Treatment visit|The analysis population included all treated participants who had at least 1 pembrolizumab concentration measurement.|||ng/mL||Full Range|Median
2572095|NCT02511184|Secondary|"Metabolite (PF-06260182) to Parent (Crizotinib) Concentration Ratio for Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab Group"|PF-06260182 is a metabolite of crizotinib.|Pre-dose, and 1, 2, 4, 6 and 8 hours post-dose on Day 15 of monotherapy and on Day 1 of Cycle 6; prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28-35 days after the last dose of study treatment)|The analysis population included all participants who had at least 1 PF-06260182 concentration measurement and at least 1 crizotinib concentration measurement.|||ratio||Full Range|Median
2572096|NCT02511184|Secondary|"Metabolite (PF-06260182) to Parent (Crizotinib) Concentration Ratio for Crizotinib + Pembrolizumab Group"|PF-06260182 is a metabolite of crizotinib.|Prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28 to 35 days after the last dose of study treatment)|The analysis population included all treated participants who had at least 1 PF-06260182 concentration measurement and at least 1 crizotinib concentration measurement.|||ratio||Full Range|Median
2572097|NCT02511184|Secondary|"Metabolite (PF-06260182) to Parent (Crizotinib) AUCtau Ratio for Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab Group"|PF-06260182 is a metabolite of crizotinib.|Pre-dose, and 1, 2, 4, 6 and 8 hours post-dose on Day 15 of monotherapy and on Day 1 of Cycle 6; prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28-35 days after the last dose of study treatment)|Data were not collected.||||||
2572098|NCT02511184|Secondary|"Metabolite (PF-06260182) to Parent (Crizotinib) AUCtau Ratio for Crizotinib + Pembrolizumab Group"|PF-06260182 is a metabolite of crizotinib.|Prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28 to 35 days after the last dose of study treatment)|Data were not collected.||||||
2572099|NCT02511184|Secondary|"Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUCtau) of PF-06260182 for Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab Group"|PF-06260182 is a metabolite of crizotinib.|Pre-dose, and 1, 2, 4, 6 and 8 hours post-dose on Day 15 of monotherapy and on Day 1 of Cycle 6; prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28-35 days after the last dose of study treatment)|Data were not collected.||||||
2572100|NCT02511184|Secondary|"Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUCtau) of PF-06260182 for Crizotinib + Pembrolizumab Group"|PF-06260182 is a metabolite of crizotinib.|Prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28 to 35 days after the last dose of study treatment)|Data were not collected.||||||
2572101|NCT02511184|Secondary|"Time to Maximum Plasma Concentration (Tmax) of PF-06260182 for Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab Group"|PF-06260182 is a metabolite of crizotinib.|Pre-dose, and 1, 2, 4, 6 and 8 hours post-dose on Day 15 of monotherapy and on Day 1 of Cycle 6; prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28-35 days after the last dose of study treatment)|Data were not collected.||||||
2572102|NCT02511184|Secondary|"Time to Maximum Plasma Concentration (Tmax) of PF-06260182 for Crizotinib + Pembrolizumab Group"|PF-06260182 is a metabolite of crizotinib.|Prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28 to 35 days after the last dose of study treatment)|Data were not collected.||||||
2572103|NCT02511184|Secondary|"Plasma Concentration Summary of PF-06260182 for Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab Group"|PF-06260182 is a metabolite of crizotinib.|Pre-dose, and 1, 2, 4, 6 and 8 hours post-dose on Day 15 of monotherapy and on Day 1 of Cycle 6; prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28-35 days after the last dose of study treatment)|The analysis population included all treated participants who had at least 1 PF-06260182 concentration measurement.|||ng/mL||Full Range|Median
2572104|NCT02511184|Secondary|"Plasma Concentration Summary of PF-06260182 for Crizotinib + Pembrolizumab Group"|PF-06260182 is a metabolite of crizotinib.|Prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28 to 35 days after the last dose of study treatment)|The analysis population included all treated participants who had at least 1 PF-06260182 concentration measurement.|||ng/mL||Full Range|Median
2572105|NCT02511184|Secondary|"Apparent Plasma Clearance (CL/F) of Crizotinib for Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab Group"||Pre-dose, and 1, 2, 4, 6 and 8 hours post-dose on Day 15 of monotherapy and on Day 1 of Cycle 6; prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28-35 days after the last dose of study treatment)|Data were not collected.||||||
2572106|NCT02511184|Secondary|"Apparent Plasma Clearance (CL/F) of Crizotinib for Crizotinib + Pembrolizumab Group"||Prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28 to 35 days after the last dose of study treatment)|Data were not collected.||||||
2572107|NCT02511184|Secondary|"Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUCtau) of Crizotinib for Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab Group"||Pre-dose, and 1, 2, 4, 6 and 8 hours post-dose on Day 15 of monotherapy and on Day 1 of Cycle 6; prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28-35 days after the last dose of study treatment)|Data were not collected.||||||
2572108|NCT02511184|Secondary|"Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUCtau) of Crizotinib for Crizotinib + Pembrolizumab Group"||Prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28 to 35 days after the last dose of study treatment)|Data were not collected.||||||
2572109|NCT02511184|Secondary|"Area Under the Plasma Concentration Time Curve From 0 to 8 Hours (AUC0-8) of Crizotinib for Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab Group"||Pre-dose, and 1, 2, 4, 6 and 8 hours post-dose on Day 15 of monotherapy and on Day 1 of Cycle 6; prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28-35 days after the last dose of study treatment)|Data were not collected.||||||
2572110|NCT02511184|Secondary|"Area Under the Plasma Concentration Time Curve From 0 to 8 Hours (AUC0-8) of Crizotinib for Crizotinib + Pembrolizumab Group"||Prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28 to 35 days after the last dose of study treatment)|Data were not collected.||||||
2572111|NCT02511184|Secondary|"Time to Maximum Plasma Concentration (Tmax) of Crizotinib for Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab Group"||Pre-dose, and 1, 2, 4, 6 and 8 hours post-dose on Day 15 of monotherapy and on Day 1 of Cycle 6; prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28-35 days after the last dose of study treatment)|Data were not collected.||||||
2572112|NCT02511184|Secondary|"Time to Maximum Plasma Concentration (Tmax) of Crizotinib for Crizotinib + Pembrolizumab Group"||Prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28 to 35 days after the last dose of study treatment)|Data were not collected.||||||
2572113|NCT02511184|Secondary|"Plasma Concentration Summary of Crizotinib for Crizotinib Monotherapy Followed by Crizotinib + Pembrolizumab Group"||Pre-dose, and 1, 2, 4, 6 and 8 hours post-dose on Day 15 of monotherapy and on Day 1 of Cycle 6; prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28-35 days after the last dose of study treatment)|The analysis population included all treated participants who had at least 1 crizotinib concentration measurement.|||ng/mL||Full Range|Median
2572114|NCT02511184|Secondary|"Plasma Concentration Summary of Crizotinib for Crizotinib + Pembrolizumab Group"||Prior to crizotinib morning dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and at the End of Treatment visit (28 to 35 days after the last dose of study treatment)|The analysis population included all treated participants who had at least 1 crizotinib concentration measurement.|||nanograms/milliliter (ng/mL)||Full Range|Median
2572115|NCT02511184|Secondary|Number of Participants With Maximum Grade in Laboratory Chemistry Test Shifting From Grade 0, 1 or 2 at Baseline to Grade 3 or 4 During Treatment|Chemistry evaluation included alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate, thyroid function tests including thyroid-stimulating hormone, T3 and free T4. Chemistry test results were graded by NCI CTCAE version 4.03.|2 years|The safety analysis set included all enrolled participants who received at least 1 dose of crizotinib or pembrolizumab.|||Participants|||Count of Participants
2572116|NCT02511184|Secondary|Number of Participants With Maximum Grade in Laboratory Hematology Test Shifting From Grade 0, 1 or 2 at Baseline to Grade 3 or 4 During Treatment|Hematology evaluation included hemoglobin, platelets, white blood cell, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, and absolute basophils. Hematology test results were graded by NCI CTCAE version 4.03.|2 years|The safety analysis set included all enrolled participants who received at least 1 dose of crizotinib or pembrolizumab.|||Participants|||Count of Participants
2572117|NCT02511184|Secondary|12-Month and 18-Month Overall Survival Probabilities|OS probabilities were defined as the probability of being alive at 12 and 18 months after the date of first dose based on the Kaplan Meier estimate.|Month 12 and Month 18|Data were not collected.||||||
2572118|NCT02511184|Secondary|Overall Survival|Overall Survival (OS) was defined as the time from the first dose of crizotinib or pembrolizumab to the date of death due to any cause. For participants who were alive at last contact, the date of last contact was used.|Day 1 to end of study (for about 2 years)|The analysis population included all treated participants who had an adequate baseline tumor assessment.|||days||Full Range|Median
2572119|NCT02511184|Secondary|6-Month, 12-Month and 18-Month Progression Free Survival Probabilities|PFS probabilities were defined as the probability of being alive and progression free at 6, 12 and 18 months after the date of first dose based on the Kaplan Meier estimate.|Month 6, Month 12, and Month 18|Data were not collected.||||||
2572120|NCT02511184|Secondary|Progression Free Survival|Progression Free Survival (PFS) was defined as the time from the first dose of crizotinib or pembrolizumab to the first documentation of objective tumor progression or death on-study due to any cause, whichever occurred first. For participants who did not have documented objective progression during the study or were alive at last contact, the date of last contact was used.|Baseline, Week 9 and every 6 weeks thereafter, for about 2 years|The analysis population included all treated participants who had an adequate baseline tumor assessment.|||days||Full Range|Median
2572121|NCT02511184|Secondary|Time to Tumor Response|Time to Tumor Response (TTR) was defined as the time from the first dose of crizotinib or pembrolizumab to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed.|Baseline, Week 9 and every 6 weeks thereafter, for about 2 years|The analysis population included all participants who achieved complete response or partial response.|||days||Full Range|Median
2572122|NCT02511184|Secondary|Duration of Response|Duration of Response (DR) was defined as the time from first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to the first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first.|Baseline, Week 9 and every 6 weeks thereafter, for about 2 years|The analysis population included all participants who achieved complete response or partial response.|||days||Full Range|Median
2572123|NCT02511184|Secondary|Objective Response Rate (ORR)|ORR refers to percentage of participants who achieved complete response (CR) or partial response (PR) in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-progressive disease (PD) or not evaluated, and no new lesions. For target lesions, CR: complete disappearance of all target lesions; PR: >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be non-pathological in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.|Baseline, Week 9 and every 6 weeks thereafter, for about 2 years|The analysis population included all treated participants who had an adequate baseline tumor assessment.|||percentage of participants|||Number
2572124|NCT02511184|Secondary|Number of Participants With Treatment-Emergent Adverse Events|AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.|2 years|The safety analysis set included all enrolled participants who received at least 1 dose of crizotinib or pembrolizumab.|||Participants|||Count of Participants
2572125|NCT02511184|Primary|Number of Participants With Dose-limiting Toxicity (DLT)|Dose-limiting toxicity (DLT) was defined as any of the following adverse events (AEs) occurring in the first 2 cycles of treatment (6 weeks) which were attributable to crizotinib, pembrolizumab or both: hematologic toxicities including Grade 4 neutropenia, febrile neutropenia, Grade greater than or equal to (>=) 3 neutropenic infection, Grade >=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; non-hematologic toxicities including Grade >=3 toxicities (non-laboratory), Grade >=3 nausea, vomiting, or diarrhea despite maximal therapy, non-hematologic Grade >=3 laboratory value if medical intervention was required to treat the participant or the abnormality led to hospitalization; inability to complete at least 80 percent of the first 2-cycle doses of crizotinib or both infusions of pembrolizumab within the DLT observation period due to treatment-related toxicity. Grade was based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) version 4.03.|6 weeks|DLT evaluable population included all participants enrolled in the Dose Finding Phase who received at least 1 dose of crizotinib or pembrolizumab, and either experienced DLT during the first 2 cycles, or completed the observation period for the first 2 cycles of treatment.|||Participants|||Count of Participants
2572126|NCT02510820|Primary|Overall Score|Subjective overall scores Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=extremely poor, 100=excellent, highly impressed.|1 week, 2 weeks, 4 weeks|Data not collected as follows: 2 weeks (1 participant) and 4 weeks (1 participant - Synergi, 1 participant - Biotrue).|||units on a scale||Standard Deviation|Mean
2572127|NCT02510820|Primary|Ease of Use of Solution|Subjective ease of use for Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visit. Scale 0-100, 0=very difficult, 100=very easy|1 week, 2 weeks, 4 weeks||||units on a scale||Standard Deviation|Mean
2572128|NCT02510820|Primary|Ease of Lens Removal|Subjective assessment of removal for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to remove, 100=excellent. no problem with lens remove.|1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
2572129|NCT02510820|Primary|Ease of Lens Insertion|Subjective assessment of insertionfor Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=unmanageable. lenses impossible to insert, 100=excellent. no problem with lens insertion.|1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
2572130|NCT02510820|Primary|Ocular Redness|Subjective ocular redness of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at 1 week, 2 week, and 4 week follow-up visits. Scale 0-100, 0=extremely poor. intolerable levels of redness, 100=excellent, no redness.|1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
2572131|NCT02510820|Primary|Burning/Stinging|Subjective assessment of burning/stinging for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=Extreme stinging / burning, 100=No stinging / burning sensation.|1 week, 2 weeks, 4 weeks||||units on a scale||Standard Deviation|Mean
2572132|NCT02510820|Primary|Dryness|Subjective assessment of dryness for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week, 2 week, and 4 week visit. Scale 0-100, 0=extremely dry 100=not dry at all.|1 week, 2 weeks, 4 weeks||||units on a scale||Standard Deviation|Mean
2572133|NCT02510820|Primary|Vision|Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 4 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.|4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
2572134|NCT02510820|Primary|Vision|Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 2 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.|2 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
2572135|NCT02510820|Primary|Vision|Subjective assessment of vision for Synergi / comfilcon A combination and Biotrue / comfilcon A combination was assessed at 1 week visit. Scale 0-100, 0=extremely poor, intolerable levels of variation in vision, 100=excellent, no variation in vision.|1 week|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
2572136|NCT02510820|Primary|Comfort|Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 4 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.|4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
2572137|NCT02510820|Primary|Comfort|Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 2 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.|2 weeks|The difference in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
2572138|NCT02510820|Primary|Comfort|Subjective comfort for Synergi / comfilcon A combination and Biotrue / comfilcon A combination is assessed at 1 week visit. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.|1 week||||units on a scale||Standard Deviation|Mean
2572139|NCT02510820|Primary|Papillary Conjunctivitis|Papillary conjunctivitis of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.|Baseline, 1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
2572140|NCT02510820|Primary|Corneal Staining|Corneal staining of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=none, 4=patch.|Baseline, 1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
2572141|NCT02510820|Primary|Limbal Hyperaemia|Limbal hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.|Baseline, 1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
2572142|NCT02510820|Primary|Conjunctival Hyperaemia|Conjunctival hyperaemia of Synergi / comfilcon A combination and Biotrue / comfilcon A combination assessed at baseline, 1 week, 2 week, and 4 week follow-up visits. Grades 0-4, 0=normal, 4=severe.|Baseline, 1 week, 2 weeks, 4 weeks|The differences in the sample size of the results vary due to lack of subjects attending their follow-up visits, however they completed the study.|||units on a scale||Standard Deviation|Mean
2572143|NCT02510664|Secondary|Provider-family Relationship, Provider-report|Providers will rate their overall satisfaction with the provider-family relationship on a scale developed for this study. The Provider-Family Relationship scale measures the provider's perspective on the quality of their relationship with the teen and family. 4 healthcare providers completed this scale for 48 families. The scale range of the minimum to maximum possible score is 1-10. A higher score represents a better outcome.|6-8 months after enrollment (follow-up timepoint)|n represents number with complete data to calculate a score. 4 healthcare providers completed this scale for 48 families (adolescent-parent dyads).|||units on a scale||Standard Deviation|Mean
2572144|NCT02510664|Secondary|Adolescent-provider Relationship - Adolescent-report|Adolescents will rate their overall satisfaction with the patient-provider relationship on a 1-10 scale single item developed for this study, as there is no validated youth-report measure of satisfaction with care. The scale ranges from 1-10, with higher scores representing a better outcome.|6-8 months after enrollment (follow-up timepoint)|n = number with data at this follow-up timepoint.|||units on a scale||Standard Deviation|Mean
2572145|NCT02510664|Secondary|Healthcare Satisfaction - PedsQL Healthcare Satisfaction Parent-report|To assess healthcare satisfaction, parents will complete three subscales of the PedsQL Inventory Healthcare Satisfaction Generic Module, assessing their satisfaction with communication, inclusion of family, and how well the patient's emotional needs are addressed during the clinical encounter (13 items). The scale ranges from 0-100, with a higher score representing a better outcome.|6-8 months after enrollment (follow-up timepoint)|n = number with complete data at this follow-up timepoint to calculate a score|||units on a scale||Standard Deviation|Mean
2572146|NCT02510664|Secondary|Diabetes-related Family Conflict (Adolescent Report)|Adolescents will also complete the Diabetes Family Conflict Scale Revised, a 19 item scale with good reliability and validity. The scale ranges from 19-57, with higher scores representing a worse outcome.|6-8 months after enrollment (follow-up timepoint)|n = number with complete data at this follow-up timepoint to calculate a score|||units on a scale||Standard Deviation|Mean
2572147|NCT02510664|Secondary|Diabetes-related Family Conflict (Parent-report)|Parents will complete the Diabetes Family Conflict Scale Revised, a 19 item scale with good reliability and validity. The scale ranges from 19-57, with higher scores representing a worse outcome.|6-8 months after enrollment (follow-up timepoint)|n = number with complete data at this follow-up timepoint to calculate a score|||units on a scale||Standard Deviation|Mean
2572148|NCT02510664|Secondary|Diabetes Burden - Problem Areas in Diabetes - Parent-report|Burden will be assessed via the Problem Areas in Diabetes measures for parents. The scale has 26 items and demonstrates good psychometric properties. The scale ranges from 26-156, with a higher score representing a worse outcome.|6-8 months after enrollment (follow-up timepoint)|n = number with complete data at this timepoint to calculate a score|||units on a scale||Standard Deviation|Mean
2572149|NCT02510664|Secondary|Problem Areas in Diabetes - Teen|Burden will be assessed via the Problem Areas in Diabetes - Teen. The scale has 26 items and demonstrates good psychometric properties. The scale ranges from 26-156, with higher scores representing worse outcomes.|6-8 months after enrollment (follow-up timepoint)|n = number with complete data at this follow-up timepoint to calculate a score|||units on a scale||Standard Deviation|Mean
2572150|NCT02510664|Secondary|Glycemic Control|Diabetes is typically diagnosed with an HbA1c of 6.5% or higher. At the time of this study, the American Diabetes Association generally recommended an HbA1c target of <7.5% for individuals younger than 18 years (the specific target varies depending on the individual). The DCA 2000 HbA1c Analyzer (Siemens-Bayer) was used for point of care HbA1c analysis, it has an analytical measurement range for HbA1c of 2.5% to 14.0%. HbA1c values are collected via fingerstick and blood assay at routine diabetes care visits and values will be extracted from the medical record at each clinic visit during the study period.|6-8 months after enrollment (follow-up timepoint)|n = number with HbA1c value available at this follow-up timepoint|||percentage||Standard Deviation|Mean
2572151|NCT02510664|Secondary|Diabetes Regimen Adherence (Blood Glucose Monitoring Frequency)|Objective measurement of adherence will occur through blood glucose monitoring frequency (a well-accepted surrogate of overall adherence), obtained via blood glucose meter downloads. The average daily frequency will be calculated over the 14 days prior to the assessment at the Baseline and second study visits.|6-8 months after enrollment (follow-up timepoint)|n = number with complete meter data at this follow-up timepoint to calculate a score|||checks per day||Standard Deviation|Mean
2572152|NCT02510664|Secondary|Diabetes Self-Management Profile - Adolescent-report|Adolescents will complete the youth-report version of the Diabetes Self-Management Profile Self-Report, a self-reported measure of adherence to diabetes regimen, at baseline and follow-up to assess their perceptions of adherence. The version appropriate to the adolescents' current diabetes regimen (conventional insulin regimen, 24 items; or intensive insulin regimen, 24 items) will be administered. The scale ranges from 0-86, with a higher score representing a better outcome.|6-8 months after enrollment (follow-up timepoint)|n = number with complete data at this follow-up timepoint to calculate a score|||units on a scale||Standard Deviation|Mean
2572958|NCT02500368|Secondary|Conjunctival Indentation|Conjunctival Indentation 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4, 0.5 steps; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe|Baseline and 1 week.||||units on a scale||Standard Deviation|Mean
2572153|NCT02510664|Secondary|Diabetes Self-Management Profile - Parent-report|Parents will rate adolescents' adherence to the diabetes regimen using the 24-item Diabetes Self-Management Profile Self-Report. The version appropriate to their child's current diabetes regimen (conventional insulin regimen, 24 items; flexible insulin regimen, 24 items) was administered. The scale ranges from 0-86, with a higher score representing a better outcome.|3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint)|n = number with complete data at baseline timepoint to calculate a score|||units on a scale||Standard Deviation|Mean
2572154|NCT02510664|Secondary|Diabetes Strengths|Adolescent will self-report on the frequency of 12 resilience-promoting behaviors via the Diabetes Strengths and Resilience, a self-report assessment of positive behaviors related to diabetes resilience for youth with type 1 diabetes, such as perceived competence to manage the demanding diabetes regimen, to adapt to the unpredictability of diabetes, and to seek help and support with diabetes challenges. The scale ranges from 0-48, with a higher score representing a better outcome.|3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint)|n = number with complete data at baseline to calculate a score|||units on a scale||Standard Deviation|Mean
2572155|NCT02510664|Primary|Acceptability: Number of Participants That Felt the Intervention Was Well-Received|The number of participants that felt the intervention was well-received was collected for Adolescents, Parents, and Providers. To determine if the intervention was well-received, verbal responses from qualitative interviews with were coded for types of participant feedback by the study team. We coded these data qualitatively and classified them as Positive, Negative, or Neutral.|6-8 months after enrollment (follow-up timepoint)|n = number with complete data at this follow-up timepoint to calculate a score.|||Participants|||Count of Participants
2572156|NCT02510664|Primary|Feasibility of Study Design|Measured by percent of participants who provided complete data from all questionnaires.|6-8 months after intervention begins (immediately following second study visit)|Out of 84 enrolled and 64 who provided baseline data, 60 (71% of enrolled, 94% of ppts with baseline data) provided post-intervention questionnaire battery (some individual measures may not have been complete to calculate a score)|||Participants|||Count of Participants
2572157|NCT02510664|Primary|Feasibility of Study Design|Measured by time to complete intervention in months since enrollment in study.|6-8 months after enrollment (follow-up timepoint)|Includes participants who completed post-intervention data|||months since enrollment||Standard Deviation|Mean
2572158|NCT02510664|Primary|Feasibility of Study Design|Measured by percent of enrolled participants who receive full dose|6-8 months after enrollment (follow-up timepoint)|84 ppts enrolled. 64 (76% of consented, 61% of eligible invited to participate) completed baseline surveys & were eligible to participate in the intervention. 63 (75% of consented, 98% of ppts with baseline data) received at least one intervention session. 53 (63% of consented, 83% of ppts with baseline data) completed 2 intervention sessions.|||Participants|||Count of Participants
2572159|NCT02510664|Primary|Feasibility of Study Design|Measured by percent of recruited families that enrolled in study|Immediately following Enrollment (Baseline)|Over 12 months (10/2014–9/2015), staff screened 212 adolescents for eligibility via electronic medical record, of whom 8 could not be contacted, 11 opted out of learning about research before the study could be introduced, & 88 were ineligible. Of the remaining 105 adolescents, 21 declined to participate, resulting in a consent rate of 80% (n=84).|||Participants|||Count of Participants
2572160|NCT02510144|Secondary|Surgical Site Infection That Requires Antibiotics|Cultures were evaluated in our lab and also tested for hemolysis as a possible indicator of a more virulent strain in the literature.|At one year||||Participants|||Count of Participants
2572161|NCT02510144|Primary|Skin Swab and Culture With Colony Forming Units (CFUs)|Preoperative Cutibacterium acnes shoulder burden. Skin cultures of both shoulders were obtained via a detergent scrub technique the day of surgery at anterior, lateral, and posterior sites and the axilla.|At time of surgery|8 samples/skin cultures were obtained from each participant; 4 from each shoulder. The contralateral shoulder was the control.|||negative skin cultures|skin cultures||Number
2572162|NCT02510014|Secondary|Cumulative Distribution Function (CDF) of the Percentage Abstinence Collected From Week 1 Through End of Study (Weeks 25 and 49)|"Participants' self-reported illicit opioid drug use from the timeline followback (TLFB) interview and results from the urine drug screens (UDS) for opioids were combined into a single endpoint. Opioids assessed included codeine, hydrocodone, hydromorphone, methadone, morphine, opiates, oxycodone, and oxymorphone (by UDS) and amphetamine/methadone, buprenorphine, methadone, and opioids in the TLFB.~Data represent the count of participants at various percentage abstinence levels. Abstinence was defined as urine samples being negative for opioids AND negative self-reports (obtained from Timeline Followback (TLFB) interviews) for illicit opioid use. The endpoint was based on visits in which paired urine samples and self-reports were expected for each subject as specified in the schedule of events. All missing reports for opioids were considered nonnegative."|Weekly during Month 1, Every other week from Month 2-6, Monthly from Month 7-12. De novo arm stopped at Week 49. Roll-over arm stopped at Week 25|Safety analysis set|||Participants|||Count of Participants
2572163|NCT02510014|Secondary|Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) at End of Study (Weeks 25 and 49)|"The opioid craving scale was a 100 mm scale with 'no craving' indicated by 0 mm and 'strongest craving ever' indicated by 100 mm. Participants marked where along the scale reflected their craving for opioids.~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values."|Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)|Safety analysis set|||units on a scale||Standard Deviation|Mean
2572164|NCT02510014|Secondary|Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) at End of Study (Weeks 25 and 49)|"The Subjective Opiate Withdrawal Scale (SOWS) contains 16 symptoms whose intensity the participant rates on a scale of 0 (not at all) to 4 (extremely) for a full scale of 0 (no withdrawal symptoms) to 64 (extreme withdrawal symptoms). Negative change from baseline values indicate a lessening of withdrawal symptoms.~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values."|Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)|Safety analysis set|||units on a scale||Standard Deviation|Mean
2572165|NCT02510014|Secondary|Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) at End of Study (Weeks 25 and 49)|"COWS is an 11-item instrument used to assess signs and symptoms of opioid withdrawal. The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderately severe withdrawal, and 37-48 severe withdrawal. Negative change from baseline values indicate a lessening of withdrawal symptoms.~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Baseline value is reported as an observed actual value. Weeks 25 and 49 represent change from baseline values."|Baseline (Day 1 predose), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)|Safety analysis set|||units on a scale||Standard Deviation|Mean
2572166|NCT02510014|Primary|Worst Local Injection Site Pain From Injections as Measured by Participant-Reported Visual Analog Scale (VAS)|"Injection site pain as measured by participant-reported VAS. The participant-reported VAS for injection site pain was measured on a 100 mm scale with 'no pain' at 0 mm and 'strongest pain ever' at 100 mm (total scale of 0-100). Participants marked where along the scale reflected their localized injection pain.~The injection site pain VAS scores were obtained (after the completion of the injection) within 1 minute and at 5, 10, 15, 30 and 60 minutes (+- 5 minutes). The timing of the injection site pain VAS should have been measured from the end of the injection.~Data represents the worst pain recorded for each participant across all injections and all VAS records. The mean value is presented.~De Novo subjects were given injections on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281 and 309.~Roll-over subjects were given injections on Days 1, 29, 57, 85, 113, 141."|De Novo Subjects: Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281 and 309 Roll-over Subjects: Days 1, 29, 57, 85, 113, 141|Safety analysis set|||units on a scale||Standard Deviation|Mean
2572167|NCT02510014|Primary|Shifts in Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Most Severe Assessment During the Treatment Period|"The C-SSRS asks questions of study participants regarding whether they had suicidal ideation and/or suicidal behavior since the last visit using the electronic version of the scale. Only the most severe assessment is reported in this summary. Participants who experienced suicidal ideation and suicidal behavior are only summarized in the suicidal behavior since behavior is more severe than ideation.~C-SSRS baseline version was completed during the screening visit. C-SSRS 'since-last-visit' version was completed weekly for the first month and at least every month until the end of the study.~Shift table category titles are structured as: baseline category/treatment category. The category 'No Suicidal Ideation or Behaviour' has been abbreviated as 'No Suicidal I or B'."|Baseline (Screening visit, days -21 to -15), End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)|Safety population. Four de novo subjects and one roll-over subject are not reported because they used the C-SSRS baseline version throughout the study.|||Participants|||Count of Participants
2572168|NCT02510014|Primary|Percentage Change From Baseline to End of Study (Weeks 25 and 49) in Vital Signs|"Vital signs include~systolic blood pressure (mmHg)~diastolic blood pressure (mmHg)~respiratory rate (breaths/minute)~weight (kg)~body mass index (kg/m^2)~waist-to-hip ratio~Baseline is defined as the last non-missing value prior to subcutaneous injection of RBP-6000 on Day 1."|Baseline (Day 1 predose) End of Study: Week 49 (De novo arm); Week 25 (Roll-over arm)|Safety analysis set of participants with both a baseline and end of study reading|||percentage change from baseline||Standard Deviation|Mean
2572169|NCT02510014|Primary|Participants With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period|TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent one of the outcomes listed in this definition.|Day 1 to Week 49 (De novo arm); Day 1 to Week 25 (Roll-over arm)|Safety analysis set|||Participants|||Count of Participants
2572170|NCT02509936|Secondary|Minimum Acceptable Diet|Number of participants who meet both minimum diet diversity and minimum meal frequency indicators. Minimum diet diversity and minimum meal frequency are both defined according to the WHO's Infant and Young Child Feeding Indicators guidelines. See the entries for minimum diet diversity and minimum meal frequency in this record for more details.|0 months, 6 months||||Participants|||Count of Participants
2572171|NCT02509936|Secondary|Minimum Meal Frequency|Number of participants meetings the age-appropriate number of solid meals per day. This is defined according to the WHO's Infant and Young Child Feeding Indicators guidelines as 2 solid meals in the last 24-hour period for breastfed infants 6-8 months old; 3 solid meals in the last 24-hour period for breastfed infants 9 months or older; 4 solid meals in the last 24-hour period for non-breastfed infants.|0 months, 6 months||||Participants|||Count of Participants
2572172|NCT02509936|Secondary|Minimum Diet Diversity|Number of participants meeting the age appropriate minimum number of food groups consumed per day. This is defined according to the WHO's Infant and Young Child Feeding Indicators guidelines as greater or equal to 4 food groups consumed in the last 24 - hour period. The 7 possible food groups are: (1) grains, roots, tubers; (2) legumes, nuts; (3) dairy products; (4) flesh foods; (5) eggs; (6) vitamin A-rich fruits and vegetables; (7) other fruits and vegetables.|0 months, 6 months||||Participants|||Count of Participants
2572180|NCT02509767|Secondary|Costs Associated With Contraceptive Care|Costs associated with contraceptive care measured by self-administered questionnaire.|6 and 12 months from enrollment|"We did not collect the data necessary to ascertain results for this outcome. While this was originally planned as a secondary study outcome, we utlimately determined that it was not feasible. Therefore we have reported 0 for this outcome and are unable to report results."||||||
2572181|NCT02509767|Secondary|Number of Participants Who Were Satisfied With Home Use of Depot Medroxyprogesterone Acetate (DMPA sc) at One Year by Self-Report in the Self-Administration Arm|Number of participants who were satisfied with home use of Depot Medroxyprogesterone Acetate (DMPA sc) at one year by self-report in the self-administration arm only as measured by self-administered questionnaire.|12 months from enrollment|Analysis population only includes participants who had complete outcome data for both the 6- and 12-month surveys.|||Participants|||Count of Participants
2572173|NCT02509936|Secondary|Expressive Language Development|Change in expressive language development score over 6 months. Tool used: Bayley III Expressive Language Observational Checklist. Z-scores derived internally from the entire baseline measurement data set for the study. A z-score of 0 is equal to the mean expressive language score for the study population at baseline. Lower numbers indicate values lower than the baseline study population mean mean and higher numbers indicate values higher than this mean. Higher values above zero are indicative of expressive language scores higher than mean baseline score for the study population. Lower values below zero are indicative of expressive language scores lower than mean baseline score for the study population. For outcomes, change values are calculated as 6 month (z-score) minus Baseline (z-score)|Baseline, 6 months|Due to expense constraints, a subset of subjects (consecutively recruited during the first 5 months (n=210 enrolled vs. 324 enrolled in study overall)) were invited to participate in the psychometric substudy. Subsequently, only 147 completed both time point assessments, and 47 were excluded for aging-out of the Z score internal reference norms.|||Z score||95% Confidence Interval|Mean
2572174|NCT02509936|Secondary|Receptive Language Development|Change in receptive language development score over 6 months. Tool used: Bayley III Receptive Language Observational Checklist. Z-scores derived internally from the entire baseline measurement data set for the study. A z-score of 0 is equal to the mean receptive language score for the study population at baseline. Lower numbers indicate values lower than the baseline study population mean mean and higher numbers indicate values higher than this mean. Higher values above zero are indicative of receptive language scores higher than mean baseline score for the study population. Lower values below zero are indicative of receptive language scores lower than mean baseline score for the study population. For outcomes, change values are calculated as 6 month (z-score) minus Baseline (z-score)|Baseline, 6 months|Due to expense constraints, a subset of subjects (consecutively recruited during the first 5 months (n=210 enrolled vs. 324 enrolled in study overall)) were invited to participate in the psychometric substudy. Subsequently, only 147 completed both time point assessments, and 47 were excluded for aging-out of the Z score internal reference norms.|||Z score||95% Confidence Interval|Mean
2572175|NCT02509936|Secondary|Fine Motor Development|Change in fine motor development score over 6 months. Tool used: Bayley III Fine Motor Observational Checklist. Z-scores derived internally from the entire baseline measurement data set for the study. A z-score of 0 is equal to the mean fine motor score for the study population at baseline. Lower numbers indicate values lower than the baseline study population mean mean and higher numbers indicate values higher than this mean. Higher values above zero are indicative of fine motor scores higher than mean baseline score for the study population. Lower values below zero are indicative of fine motor scores lower than mean baseline score for the study population. For outcomes, change values are calculated as 6 month (z-score) minus Baseline (z-score)|Baseline, 6 months|Due to expense constraints, a subset of subjects (consecutively recruited during the first 5 months (n=210 enrolled vs. 324 enrolled in study overall)) were invited to participate in the psychometric substudy. Subsequently, only 147 completed both time point assessments, and 47 were excluded for aging-out of the Z score internal reference norms.|||Z score||95% Confidence Interval|Mean
2572176|NCT02509936|Secondary|Gross Motor Development|Change in gross motor development score over 6 months. Tool used: Bayley III Gross Motor Observational Checklist. Z-scores derived internally from the entire baseline measurement data set for the study. A z-score of 0 is equal to the mean gross motor score for the study population at baseline. Lower numbers indicate values lower than the baseline study population mean mean and higher numbers indicate values higher than this mean. Higher values above zero are indicative of gross motor scores higher than mean baseline score for the study population. Lower values below zero are indicative of gross motor scores lower than mean baseline score for the study population. For outcomes, change values are calculated as 6 month (z-score) minus Baseline (z-score)|Baseline, 6 months|Due to expense constraints, a subset of subjects (consecutively recruited during the first 5 months (n=210 enrolled vs. 324 enrolled in study overall)) were invited to participate in the psychometric substudy. Subsequently, only 147 completed both time point assessments, and 47 were excluded for aging-out of the Z score internal reference norms.|||Z score||95% Confidence Interval|Mean
2572177|NCT02509936|Secondary|Socioemotional Development|Change in socioemotional development score over 6 months. Tool used: Bayley III Socioemotional Development Parent Questionnaire. Z-scores derived internally from the entire baseline measurement data set for the study. A z-score of 0 is equal to the mean socioemotional score for the study population at baseline. Lower numbers indicate values lower than the baseline study population mean mean and higher numbers indicate values higher than this mean. Higher values above zero are indicative of socioemotional scores higher than mean baseline score for the study population. Lower values below zero are indicative of socioemotional scores lower than mean baseline score for the study population. For outcomes, change values are calculated as 6 month (z-score) minus Baseline (z-score)|Baseline, 6 months|Due to expense constraints, a subset of subjects (consecutively recruited during the first 5 months (n=210 enrolled vs. 324 enrolled in study overall)) were invited to participate in the psychometric substudy. Subsequently, only 147 completed both time point assessments, and 47 were excluded for aging-out of the Z score internal reference norms.|||Z score||95% Confidence Interval|Mean
2572178|NCT02509936|Secondary|Cognitive Development|Change in cognitive development Z score over 6 months. Tool used: Bayley III Cognitive Development Observational Checklist. Z-scores derived internally from the entire baseline measurement data set for the study. A z-score of 0 is equal to the mean cognitive score for the study population at baseline. Lower numbers indicate values lower than the baseline study population mean mean and higher numbers indicate values higher than this mean. Higher values above zero are indicative of cognitive scores higher than mean baseline score for the study population. Lower values below zero are indicative of cognitive scores lower than mean baseline score for the study population. For outcomes, change values are calculated as 6 month (z-score) minus Baseline (z-score)|Baseline, 6 months|Due to expense constraints, a subset of subjects (consecutively recruited during the first 5 months (n=210 enrolled vs. 324 enrolled in study overall)) were invited to participate in the psychometric substudy. Subsequently, only 147 completed both time point assessments, and 47 were excluded for aging-out of the Z score internal reference norms.|||Z score||95% Confidence Interval|Mean
2572179|NCT02509936|Primary|Change in Height/Length for Age Z Score|Change in height/length over 6 months. Tool used is the WHO Child Growth Reference Standards. Change values calculated as: 6 month (z-score) minus Baseline (z-score).|Baseline, 6 months||||Z scores||Standard Deviation|Mean
2572182|NCT02509767|Secondary|Number of Participants Who Were Satisfied With Depot Medroxyprogesterone Acetate (DMPA sc) at One Year by Self-Report in Both the Self- and Clinic Administration Arms|Number of participants who reported being very or somewhat satisfied with Depot Medroxyprogesterone Acetate (DMPA sc) at one year in both the self- and clinic administration arms measured by self-administered questionnaire.|12 months from enrollment|Analysis population only includes participants who had complete outcome data for both the 6- and 12-month surveys.|||Participants|||Count of Participants
2572183|NCT02509767|Primary|Number of Participants With Depot Medroxyprogesterone Acetate (DMPA sc) Continuation at One Year by Self-report in Both the Self- and Clinic Administration Arms|Number of participants with Depot Medroxyprogesterone Acetate (DMPA sc) continuation at one year by self-report in both the self- and clinic administration arms measured by self-administered questionnaire.|12 months from enrollment||||Participants|||Count of Participants
2572184|NCT02509585|Secondary|Incidence of Adverse Events||7 days|Enrolled subjects who were administered any injection of Tc99m tilmanocept.|||Events|||Number
2572185|NCT02509585|Secondary|Per-subject Reverse Concordance|Number of subjects whose lymph nodes that were identified by Lymphoseek were also all identified by dye|1 day|Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available|||Proportion of Reverse Condordant Subj.|Hot Positive Nodes|95% Confidence Interval|Number
2572186|NCT02509585|Secondary|Per-subject Concordance|Subjects whose lymph nodes were determined to be dye positive that were also identified by Lymphoseek|1 day|Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available|||Proportion of Condordant Subjects|Dye Positive Nodes|95% Confidence Interval|Number
2572187|NCT02509585|Secondary|Number of Lymph Nodes Per-subject Identified by Other Dyes||1 day||||Nodes Per Subject|Total Lymph Nodes|95% Confidence Interval|Mean
2572188|NCT02509585|Secondary|Number of Lymph Nodes Per-subject Identified by Lymphoseek||1 day|Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available|||Nodes Per Subject|Total Lymph Nodes|95% Confidence Interval|Mean
2572189|NCT02509585|Secondary|Proportion of Lymph Nodes Identified Intraoperatively by a Dye That Are Also Identified by Lymphoseek||1 day|Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available|||Proportion of Condordant Nodes|Dye Positive Nodes|95% Confidence Interval|Number
2572190|NCT02509585|Secondary|Per-subject Accuracy|Proportion of subjects accurately indentified by Lymphoseek|1 day|Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available|||Proportion of participants||95% Confidence Interval|Number
2572191|NCT02509585|Secondary|Per-subject Negative Predictive Value|Proportion of subjects with pathologically negative Lymphoseek-identified SLN(s) with no pathologically positive lymph nodes|1 day|Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available|||Proportion of participants||95% Confidence Interval|Number
2572192|NCT02509585|Secondary|Per-subject Sensitivity|Proportion of subjects with at least one pathologically positive Lymphoseek-identified SLN that have at least one pathologically positive lymph node|1 day|Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available|||Proportion of participants||95% Confidence Interval|Number
2572193|NCT02509585|Primary|Per-subject False Negative Rate|Proportion of subjects with pathologically negative Lymphoseek-identified SLNs and at least one pathologically positive non-SLN|1 day|Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available|||Proportion of Participants||95% Confidence Interval|Number
2572194|NCT02509481|Secondary|Entomological Inoculation Rate|The entomological inoculation rate (EIR per week per person) is the measure of the human biting rate per person per week, multiplied by the sporozoite rate (in biting mosquitoes) per week, an estimated from sampling mosquitoes from 8 households located in the center of each study village. The EIR was calculated for each of the 6 sampling weeks of the treatment phase.|6 sampling periods over 18 weeks, starting in week 2 following the first MDA, and sampling every 3 weeks thereafter until week 17 of the treatment phase.|The mean EIR was calculated across the 6 sampling periods in the 8 study villages (4 villages in each arm). EIR was calculated from the number of mosquitoes captured in select houses and the number of enrolled participants who lived in each sampled house (324/1265 in single MDA arm, and 271/1447 in repeated MDA arm).|||infectious bites per person per week||Standard Deviation|Mean
2572195|NCT02509481|Secondary|Number of 6-10 Year Old Participants With Soil Transmitted Helminths (STH)|Prevalence of soil transmitted helminth infections in children between 6-10 years old from the beginning to the end of the intervention|Approximately 20 weeks, from before the start of the first MDA to 4 weeks following the last MDA in the Experimental arm|This outcome was only measured in older enrolled children between 6-10 years of age, who were not in our primary outcome cohort, and who were eligible to be treated with ivermectin due to their height >90 cm (232 of 2712 participants).|||participants|||Number
2572196|NCT02509481|Secondary|Molecular Force of P. Falciparum Infection|Examination of new P. falciparum clones acquired from the beginning to the end of the intervention (molecular force of infection; mFOI) per child. Molecular genotyping used capillary blood taken at the time of diagnosis of each positive malaria episode and consisted of nPCR of the msp2 gene. We calculated the multiplicity of infection (MOI) per malaria episode, and then calculated the molecular force of infection (mFOI) associated with malaria episodes per child (over course of the trial)|Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm|Molecular genotyping was performed on blood samples from 132 enrolled cohort children who were selected using a random sequence generator. Genotyping was successful on blood spots corresponding to 153 malaria episodes, which allowed us to calculate the mFOI over the trial from 76 enrolled children from the cohort.|||new P. faliciparum infections per child||Inter-Quartile Range|Median
2572197|NCT02509481|Secondary|Entomological Indicator of Parasite Transmission|Change in human IgG reactivity (optical density; ∆OD) to an Anopheles salivary gland antigen (peptide gSG6-P1) over the trial period. A score of 0 indicates no change in seroreactivity from from immediately before to immediately after the trial, suggesting consistent mosquito biting throughout the trial. A positive score indicates increasing seroreactivity and thus increasing mosquito biting on participants from immediately before to immediately after the trial. A negative score indicates decreasing seroreactivity and thus decreasing mosquito biting on participants from immediately before to immediately after the trial.|Approximately 20 weeks, from before the start of the first MDA to 4 weeks following the last MDA in the Experimental arm|We sampled finger capillary blood pre-intervention from a subset of enrolled participants located in 8 households at the center of each study village, and then re-sampled their blood immediately after the intervention period. Data were reported only from participants that gave both sets of samples (221 of 2712 participants).|||change in IgG ELISA optical density||95% Confidence Interval|Mean
2572198|NCT02509481|Secondary|Adverse Events|The number of adverse events. Adverse events data were collected via passive case detection from total population.|Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm|Per protocol, the secondary outcome was a measure of all adverse events, excluding uncomplicated malaria episodes that were reported in the primary outcome, that occurred among the total enrolled population from the study villages (2712 participants).|||adverse events|||Number
2572199|NCT02509481|Primary|Incidence of Clinical Malaria Episodes|Cumulative incidence of malaria episodes in a cohort of village children ≤ 5 years of age (as assessed by active case surveillance in study villages - malaria episode defined as ≥38.0°C fever or history of fever in the last 24 hours + positive rapid diagnostic test for Plasmodium falciparum). Incidence is reported as malaria episodes per child over the course of the trial, a higher incidence is a worse outcome.|Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm|Note that the primary outcome measure comes only from malaria incidence measurements within this child cohort (590 children). It is not a measure of malaria incidence from all enrolled participants from the study villages (2712 participants).|||episodes||95% Confidence Interval|Mean
2572200|NCT02509117|Secondary|Part C: Plasma Decay Half-Life (t1/2) of PF-06751979 at Day 14|Plasma decay half-life is the time measured for the plasma concentration of PF-06751979 to decrease by one half of its original concentration.|predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hour post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, ‘number of participants analyzed’ signifies participants who were evaluable for this outcome measure.|||hours||Standard Deviation|Mean
2572201|NCT02509117|Secondary|Part C: Apparent Volume of Distribution (Vz/F) of PF-06751979 at Day 14|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hour post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, ‘number of participants analyzed’ signifies participants who were evaluable for this outcome measure.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2572202|NCT02509117|Secondary|Part C: Observed Accumulation Ratio for Maximum Observed Plasma Concentration (Rac Cmax) of PF 06751979 at Day 14|Rac for Cmax for Day 14 was calculated as: Cmax on Day 14 divided by Cmax on Day 1, where Cmax was the maximum observed plasma concentration.|predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hour post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hour post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here,‘number of participants analyzed’=participants evaluable for this outcome measure. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2572203|NCT02509117|Secondary|Part C: Observed Accumulation Ratio (Rac) for AUCtau of PF-06751979 at Day 14|Rac for AUCtau at Day 14 was calculated as: AUCtau on Day 14 divided by AUCtau on Day 1, where Cmax was the maximum observed plasma concentration.|predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hour post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hour post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here,‘number of participants analyzed’=participants evaluable for this outcome measure. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2572204|NCT02509117|Secondary|Part C: Peak-to-Trough Ratio (PTR) of PF-06751979 at Day 14|PTR was calculated by dividing Cmax by Cmin of PF-06751979 administered to a participant.|predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here,‘number of participants analyzed’=participants evaluable for this outcome measure. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2572205|NCT02509117|Secondary|Part C: Minimum Observed Plasma Concentration (Cmin) of PF-06751979 on Day 14||predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here,‘number of participants analyzed’=participants evaluable for this outcome measure. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2572206|NCT02509117|Secondary|Part C: Apparent Oral Clearance (CL/F) of PF-06751979 on Day 14|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, ‘number of participants analyzed’ signifies participants who were evaluable for this outcome measure.|||milliliter per minute||Geometric Coefficient of Variation|Geometric Mean
2572207|NCT02509117|Secondary|Part C: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval Tau (AUCtau)(Dn) of PF-06751979|Dose normalized area under the concentration curve from time 0 to end of dosing interval (AUCtau)(dn), where dosing interval was 24 hours. AUCtau(dn) was calculated by dividing AUCtau by the exact dose of PF-06751979 (in mg) administered to a participant.|predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24 hours post dose on Day 14|PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, number analyzed signifies participants who were evaluable at specified time points. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||[nanogram*hour/milliliter]/milligram||Geometric Coefficient of Variation|Geometric Mean
2572208|NCT02509117|Secondary|Part C: Dose Normalized Maximum Observed Plasma Concentration (Cmax)(Dn) of PF-06751979|Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of PF-06751979 (in mg) administered.|predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time points.|||[nanogram/milliliter]/milligram||Geometric Coefficient of Variation|Geometric Mean
2572209|NCT02509117|Secondary|Part C: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979||predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time points.|||hours||Full Range|Median
2572210|NCT02509117|Secondary|Part C: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06751979|Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours.|predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hour post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24 hour post dose on Day 14|PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, number analyzed signifies participants who were evaluable at specified time points. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2572211|NCT02509117|Secondary|Part C: Maximum Observed Plasma Concentration (Cmax) of PF-06751979||predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hour post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hour post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured.|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2572212|NCT02509117|Secondary|Part B: Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) Fragments on Day 14|ABeta is the peptide fragment of the amyloid precursor protein. Percent change from baseline in CSF concentration of ABeta fragments (ABeta x-40, ABeta 1-40 and ABeta total) at Day 14 was reported in this outcome measure.|Baseline, Day 14|The pharmacodynamic CSF concentration population was defined as all enrolled and treated participants who had at least 1 measureable CSF ABeta concentration. Data for this outcome measure was not planned to be analyzed for Part A and C, as pre specified in protocol.|||percent change||Standard Error|Mean
2572213|NCT02509117|Secondary|Part B: Renal Clearance of PF-06751979|Renal clearance was calculated as amount of drug excreted unchanged in urine during the dosing interval tau (Aetau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours.|0-24 hours on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A and C, as pre specified in protocol.|||milliliter per minute||Geometric Coefficient of Variation|Geometric Mean
2572214|NCT02509117|Secondary|Part B: Percentage of Dose of PF-06751979 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%)|Aetau% was calculated as: 100*Aetau/dose. Aetau is the amount of drug excreted unchanged in urine during the dosing interval (tau), where dosing interval was 24 hours.|0-24 hours on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A and C, as pre specified in protocol.|||Percentage of dose excreted||Geometric Coefficient of Variation|Geometric Mean
2572215|NCT02509117|Secondary|Part B: Amount of PF-06751979 Excreted Unchanged in Urine Over the Dosing Interval Tau (Aetau)|Aetau is the amount of drug excreted unchanged in urine during the dosing interval (tau), where dosing interval was 24 hours.|0-24 hours on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A and C, as pre specified in protocol.|||milligram||Geometric Coefficient of Variation|Geometric Mean
2572216|NCT02509117|Secondary|Part B: Plasma Decay Half-Life (t1/2) of PF-06751979 at Day 14|Plasma decay half-life is the time measured for the plasma concentration of PF-06751979 to decrease by one half of its original concentration.|predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hour post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured.|||hours||Standard Deviation|Mean
2572217|NCT02509117|Secondary|Part B: Observed Accumulation Ratio for Maximum Observed Plasma Concentration (Rac Cmax) of PF-06751979 at Day 7, 14|Rac for Cmax for Day 7 was calculated as: Cmax on Day 7 divided by Cmax on Day 1. Rac for Cmax for Day 14 was calculated as: Cmax on Day 14 divided by Cmax on Day 1, where Cmax was the maximum observed plasma concentration.|predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2572218|NCT02509117|Secondary|Part B: Observed Accumulation Ratio (Rac) for AUCtau of PF-06751979 at Day 7, 14|Rac for AUCtau for Day 7 was calculated as: AUCtau on Day 7 divided by AUCtau on Day 1. Rac for AUCtau for Day 14 was calculated as: AUCtau on Day 14 divided by AUCtau on Day 1.|predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2572219|NCT02509117|Secondary|Part B: Peak-to-Trough Ratio (PTR) of PF-06751979|PTR was calculated by dividing Cmax by Cmin of PF-06751979 administered to a participant.|predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2572220|NCT02509117|Secondary|Part B: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval Tau (AUCtau)(Dn) of PF-06751979|Dose normalized area under the concentration curve from time 0 to end of dosing interval (AUCtau)(dn), where dosing interval was 24 hours. AUCtau(dn) was calculated by dividing AUCtau by the exact dose of PF-06751979 (in mg) administered to a participant.|predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24 hours post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||[nanogram*hour/milliliter]/milligram||Geometric Coefficient of Variation|Geometric Mean
2572221|NCT02509117|Secondary|Part B: Minimum Observed Plasma Concentration (Cmin) of PF-06751979||predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2572222|NCT02509117|Secondary|Part B: Apparent Oral Clearance (CL/F) of PF-06751979|Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood.|predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured.|||milliliter per minute||Geometric Coefficient of Variation|Geometric Mean
2572223|NCT02509117|Secondary|Part B: Dose Normalized Maximum Observed Plasma Concentration (Cmax)(Dn) of PF-06751979|Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of PF-06751979 (in mg) administered.|predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured.|||[nanogram/milliliter]/milligram||Geometric Coefficient of Variation|Geometric Mean
2572224|NCT02509117|Secondary|Part B: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979||predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured.|||hours||Full Range|Median
2572225|NCT02509117|Secondary|Part B: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06751979|Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours.|predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24 hours post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2572226|NCT02509117|Secondary|Part B: Maximum Observed Plasma Concentration (Cmax) of PF-06751979||predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 1; predose, 0.5, 1, 1.5, 2, 4, 8, 12 and 24 hours post dose on Day 7; predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured.|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2572227|NCT02509117|Secondary|Part B: Apparent Volume of Distribution (Vz/F) of PF-06751979 at Day 14|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2572228|NCT02509117|Secondary|Part A: Apparent Volume of Distribution (Vz/F) of PF-06751979|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2572229|NCT02509117|Secondary|Part A: Apparent Oral Clearance (CL/F) of PF-06751979|Drug clearance is the quantitative measure of the rate at which a drug substance is removed from the blood.|predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||milliliter per minute||Geometric Coefficient of Variation|Geometric Mean
2572230|NCT02509117|Secondary|Part A: Plasma Decay Half-Life (t1/2) of PF-06751979|Plasma decay half-life is the time measured for the plasma concentration of PF-06751979 to decrease by one half of its original concentration.|predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hours||Standard Deviation|Mean
2572231|NCT02509117|Secondary|Part A: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979||predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured.|||hours||Full Range|Median
2572232|NCT02509117|Secondary|Part A: Dose Normalized Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)(Dn) of PF-06751979|AUCinf(dn) was calculated by dividing AUCinf by the exact dose of PF-06751979 (in mg) administered.|predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1|PK parameter population: all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, ‘number of participants analyzed’= participants evaluable for this outcome measure. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.|||[nanogram*hour/milliliter]/milligram||Geometric Coefficient of Variation|Geometric Mean
2572233|NCT02509117|Secondary|Part A: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(Dn) of PF-06751979|AUClast(dn) was calculated by dividing AUClast by the exact dose of PF-06751979 (in mg) administered.|predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1|PK parameter population: all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.|||[nanogram*hour/milliliter]/milligram||Geometric Coefficient of Variation|Geometric Mean
2572234|NCT02509117|Secondary|Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax)(dn) of PF-06751979|Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of PF-06751979 (in mg) administered.|predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured.|||[nanogram/milliliter]/milligram||Geometric Coefficient of Variation|Geometric Mean
2572235|NCT02509117|Secondary|Part A: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06751979||predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1|PK parameter population: all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Here, ‘number of participants analyzed’= participants evaluable for this outcome measure. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2572236|NCT02509117|Secondary|Part A: Area Under the Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of PF-06751979|AUClast is the area under the plasma concentration time-curve from time zero to the time of last quantifiable concentration.|predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1|The PK parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2572237|NCT02509117|Secondary|Part A: Maximum Observed Plasma Concentration (Cmax) of PF-06751979||predose, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 24, 36, 48 and 72 hours post dose on Day 1|The pharmacokinetic (PK) parameter population included all enrolled participants who had at least 1 dose of PF-06751979 and at least 1 of the PK parameters of interest measured.|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2572238|NCT02509117|Primary|Part A: Number of Participants With Cardiac Rhythms of Potential Clinical Concern Assessed By Telemetry|Continuous cardiac telemetry was conducted in participants. All abnormal cardiac rhythms were recorded and reviewed by the study physician for the presence of rhythms of potential clinical concern. In this outcome measure, number of participants who had cardiac rhythms of potential clinical concern (based on physician's discretion) were reported.|Day 1|Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.|||participants|||Number
2572239|NCT02509117|Primary|Number of Participants With Clinically Significant Changes From Baseline in Vital Signs|Following parameters were analyzed for examination of vital signs: supine systolic and diastolic blood pressure, pulse rate and body temperature.|Part A: Baseline up to 47 days, Part B and C: Baseline up to 29 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2572247|NCT02509117|Primary|Number of Participants With Abnormal Physical Examinations Findings|A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Abnormality in physical examinations was based on investigator's discretion.|Part A: Baseline up to 47 days, Part B and C: Baseline up to 29 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2572380|NCT02506881|Secondary|Cl|Serum clearance of of darbepoetin alfa after single sc of iv administration. Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis: patients who received at least one study drug injection.|||hours*kg||Inter-Quartile Range|Median
2572240|NCT02509117|Primary|Number of Participants With Laboratory Abnormalities|Abnormalities criteria:hematology(hemoglobin; hematocrit; RBC<0.8*lower limit of normal [LLN]; platelets<0.5*LLN,>1.75*upper limit of normal [ULN]; WBC<0.6*LLN,>1.5*ULN; lymphocytes; neutrophils; basophils; eosinophils; monocytes<0.8*LLN,>1.2*ULN; coagulation(prothrombin (PT); PT ratio>1.1*ULN), liver(bilirubin>1.5*ULN; aspartate aminotransferase; alanine aminotransferase; alkaline phosphatase; gamma GT>0.3*ULN; protein; albumin<0.8*LLN,>1.2*ULN); renal(blood urea nitrogen, creatinine>1.3*ULN; uric acid>1.2*ULN); electrolytes(sodium<0.95*LLN,>1.05*ULN; potassium; chloride; calcium; bicarbonate<0.9*LLN,>1.1*ULN), chemistry(glucose<0.6*LLN,>1.5* ULN); urinalysis(pH <4.5,>8; glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte, esterase>1; WBC; bacteria>=20, epithelial cells>=6; granular casts, hyaline casts, red cell casts, white cell casts>1; lipids(cholesterol[C], LDL-C>1.3*ULN; HDL-C<0.8*LLN, triglycerides>1.3*ULN); hormones(T4, T3, T4, TSH<0.8*LLN,>1.2*ULN)|Part A: Baseline up to 47 days, Part B and C: Baseline up to 29 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2572241|NCT02509117|Primary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities|Criteria for clinically significant ECG abnormalities: maximum PR interval >=300 milliseconds (msec) and maximum PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 msec and Pctchg>=50% for baseline value of <=200 msec for PR interval, maximum QRS interval >=140 msec and a maximum IFB: Pctchg>=50%, maximum QTCF interval (Fridericia's Correction) of 450 msec to <480 msec, 480 msec to <500 msec or >=500 msec and a maximum change of <=30 change <60 or >=60 msec from baseline.|Part A: Baseline up to 47 days, Part B and C: Baseline up to 29 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2572242|NCT02509117|Primary|Part B and C: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 19|"C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of Yes on actual attempt); preparatory acts toward imminent suicidal behavior (Yes on preparatory acts or behavior, aborted attempt or interrupted attempt), suicidal ideation (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent). In this outcome, number of participants with positive response (response of yes) to suicidal behavior, ideation or any self-injurious behavior, at Day 19 were reported."|Day 19|Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||participants|||Number
2572243|NCT02509117|Primary|Part B and C: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 14|"C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of Yes on actual attempt); preparatory acts toward imminent suicidal behavior (Yes on preparatory acts or behavior, aborted attempt or interrupted attempt), suicidal ideation (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent). In this outcome, number of participants with positive response (response of yes) to suicidal behavior, ideation or any self-injurious behavior, at Day 14 were reported."|Day 14|Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||participants|||Number
2572244|NCT02509117|Primary|Part B and C: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) on Day 7|"C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of Yes on actual attempt); preparatory acts toward imminent suicidal behavior (Yes on preparatory acts or behavior, aborted attempt or interrupted attempt), suicidal ideation (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent). In this outcome, number of participants with positive response (response of yes) to suicidal behavior, ideation or any self-injurious behavior, at day 7 were reported."|Day 7|Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||participants|||Number
2572245|NCT02509117|Primary|Part B and C: Number of Participants With Positive Response on Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline|"C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of Yes on actual attempt); preparatory acts toward imminent suicidal behavior (Yes on preparatory acts or behavior, aborted attempt or interrupted attempt), suicidal ideation (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent). In this outcome measure, number of participants with positive response (response of yes) to suicidal behavior, ideation or any non-suicidal self-injurious behavior, at baseline were reported."|Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.|||participants|||Number
2572246|NCT02509117|Primary|Number of Participants With Abnormal Neurological Examinations Findings|The neurological examination included the assessment of higher cortical function, the cranial nerves, motor function, deep tendon reflexes, sensory exam, and coordination and gait. Abnormality in neurological examinations was based on investigator's discretion.|Part A: Baseline up to 47 days, Part B and C: Baseline up to 29 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2572381|NCT02506881|Secondary|Tmax|Time to achieve maximum serum concentration of darbepoetin alfa after single sc of iv administration|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis: patients who received at least one study drug injection.|||hours||Inter-Quartile Range|Median
2572248|NCT02509117|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug up to the follow up visit (up to 47 days in Part A, 29 days in Part B and C), that were absent before treatment or that worsened relative to pretreatment state.|Part A: Baseline up to 47 days; Part B and C: Baseline up to 29 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2572249|NCT02509078|Secondary|PTSS-14: Post-traumatic Stress-like Symptoms Scores >/= 45|Does the patient have symptoms of anxiety and stress from their ICU stay? PTSS-14 is only asked at month 6 and month 12 in patient survey; total score is rated from 14 to 98 and a higher score indicates having more post-traumatic stress syndrome related symptoms. Participants with scores greater than or equal to 45 were reported.|12 months after randomization|The overall number of participants analyzed reflects the number of patients that were alive, able to be contacted, and had sufficient data to allow for calculation of the outcome measure.|||participants|||Number
2572250|NCT02509078|Secondary|MoCA-Blind: Montreal Cognitive Assessment|"How clearly can patient think and recall things? MoCA-Blind is only asked in patient survey; total score is rated from 0 to 30 and a higher score indicates better cognitive performance. Normal range:~26 or greater."|12 months after randomization|The overall number of participants analyzed reflects the number of patients that were alive, able to be contacted, and had sufficient data to allow for calculation of the outcome measure.|||score on a scale||Standard Deviation|Mean
2572251|NCT02509078|Secondary|MoCA-Blind: Montreal Cognitive Assessment|"How clearly can patient think and recall things? MoCA-Blind is only asked in patient survey; total score is rated from 0 to 30 and a higher score indicates better cognitive performance. Normal range:~26 or greater."|6 months after randomization|The overall number of participants analyzed reflects the number of patients that were alive, able to be contacted, and had sufficient data to allow for calculation of the outcome measure.|||score on a scale||Standard Deviation|Mean
2572252|NCT02509078|Secondary|EuroQol (EQ-5D-5L): Health Related Quality of Life|Using a standardized scale, do health reasons limit the person's ability to enjoy their life? Pooled estimates from patient survey and proxy survey were used. Utility index was computed from a lookup table according to EQ-5D-5L response profiles; utility index ranges from -0.11 to 1.00 (higher scores are better; 1.00 is perfect health), minimal clinically important difference (MCID) is 0.07|12 months after randomization|The overall number of participants analyzed reflects the number of patients that were alive, able to be contacted, and had sufficient data to allow for calculation of the outcome measure.|||score on a scale||Inter-Quartile Range|Median
2572253|NCT02509078|Secondary|EuroQol (EQ-5D-5L): Health Related Quality of Life|Using a standardized scale, do health reasons limit the person's ability to enjoy their life? Pooled estimates from patient survey and proxy survey were used. Utility index was computed from a lookup table according to EQ-5D-5L response profiles; utility index ranges from -0.11 to 1.00 (higher scores are better; 1.00 is perfect health), minimal clinically important difference (MCID) is 0.07|6 months after randomization|The overall number of participants analyzed reflects the number of patients that were alive, able to be contacted, and had sufficient data to allow for calculation of the outcome measure.|||score on a scale||Inter-Quartile Range|Median
2572254|NCT02509078|Secondary|Katz Activities of Daily Living (ADL)/Lawton Instrumental Activities Of Daily Living Scale (IADL)|Assesses whether individual can living independently and assess a range of common functional activities, from walking and toileting to managing money and cooking meals. Data is a pooled estimates from patient survey and proxy survey. The total score is rated from 0 to 10 (MCID=1; 1 point=1 ADL); a higher score indicates having more difficulties in daily activities.|12 months after randomization|The overall number of participants analyzed reflects the number of patients that were alive, able to be contacted, and had sufficient data to allow for calculation of the outcome measure.|||score on a scale||Standard Deviation|Mean
2572255|NCT02509078|Secondary|Katz Activities of Daily Living (ADL)/Lawton Instrumental Activities Of Daily Living Scale (IADL)|Assesses whether individual can living independently and assess a range of common functional activities, from walking and toileting to managing money and cooking meals. Data is a pooled estimates from patient survey and proxy survey. The total score is rated from 0 to 10 (MCID=1; 1 point=1 ADL); a higher score indicates having more difficulties in daily activities.|6 months after randomization|The overall number of participants analyzed reflects the number of patients that were alive, able to be contacted, and had sufficient data to allow for calculation of the outcome measure.|||score on a scale||Standard Deviation|Mean
2572256|NCT02509078|Secondary|MoCA-Blind: Montreal Cognitive Assessment|How clearly can patient think and recall things? MoCA-Blind is only asked in patient survey; total score is rated from 0 to 30 and a higher score indicates better cognitive performance. Normal range: 26 or greater.|3 months after randomization|The overall number of participants analyzed reflects the number of patients that were alive, able to be contacted, and had sufficient data to allow for calculation of the outcome measure.|||score on a scale||Standard Deviation|Mean
2572257|NCT02509078|Secondary|PTSS-14: Post-traumatic Stress-like Symptoms Scores >/= 45|Does the patient have symptoms of anxiety and stress from their ICU stay? PTSS-14 is only asked at month 6 and month 12 in patient survey; total score is rated from 14 to 98 and a higher score indicates having more post-traumatic stress syndrome related symptoms. Participants with scores greater than or equal to 45 were reported.|6 months after randomization|The overall number of participants analyzed reflects the number of patients that were alive, able to be contacted, and had sufficient data to allow for calculation of the outcome measure.|||participants|||Number
2572258|NCT02509078|Secondary|EuroQol (EQ-5D-5L): Health Related Quality of Life|Using a standardized scale, do health reasons limit the person's ability to enjoy their life? Pooled estimates from patient survey and proxy survey were used. Utility index was computed from a lookup table according to EQ-5D-5L response profiles; utility index ranges from -0.11 to 1.00 (higher scores are better; 1.00 is perfect health), minimal clinically important difference (MCID) is 0.07|3 months after randomization|The overall number of participants analyzed reflects the number of patients that were alive, able to be contacted, and had sufficient data to allow for calculation of the outcome measure.|||score on a scale||Inter-Quartile Range|Median
2572259|NCT02509078|Secondary|Katz Activities of Daily Living (ADL)/Lawton Instrumental Activities Of Daily Living Scale (IADL)|Assesses whether individual can living independently and assess a range of common functional activities, from walking and toileting to managing money and cooking meals. Data is a pooled estimates from patient survey and proxy survey. The total score is rated from 0 to 10 (MCID=1; 1 point=1 ADL); a higher score indicates having more difficulties in daily activities.|3 months after randomization|The overall number of participants analyzed reflects the number of patients that were alive, able to be contacted, and had sufficient data to allow for calculation of the outcome measure.|||score on a scale||Standard Deviation|Mean
2572260|NCT02509078|Secondary|Mean Hospital Free Days to Days 28|Hospital free days are days alive post hospital discharge through day 28. Patients who die on or prior to day 28 are assigned zero hospital free days.|28 days after randomization||||days||Standard Deviation|Mean
2572261|NCT02509078|Secondary|ICU Free Days to Day 28|ICU free days is defined as the number of days between randomization and day 28 in which the patient is in the ICU (for any part of a day).|28 days after randomization|The overall number of participants analyzed reflects the number of patients that had sufficient data to allow for calculation of the outcome measure.|||days||Standard Deviation|Mean
2572262|NCT02509078|Secondary|Mean Organ Failure Free Days to Day 28|"SOFA (Sepsis-related Organ Failure Assessment) was used to determine criteria for an organ failure free day. Scores were based on four of the six SOFA organ categories: Coagulation, Liver, Cardiovascular, and Renal. Each category was scored 0-4; 0 being normal functioning and 4 being the most abnormal. A patient was considered failure free on each day alive with SOFA scores below 2 for all four organ systems.~Ref: Vincent, J.L., et al., The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med, 1996. 22(7): p. 707-10."|28 days after randomization|The overall number of participants analyzed reflects the number of patients that had sufficient data to allow for calculation of the outcome measure.|||days||Standard Deviation|Mean
2572263|NCT02509078|Secondary|Mean Ventilator Free Days to Day 28|Ventilator-free days is defined to be 28 days minus the duration of mechanical ventilation through day 28. Participants who do not survive to day 28 are assigned zero ventilator-free days.|28 days after randomization|The overall number of participants analyzed reflects the number of patients that had sufficient data to allow for calculation of the outcome measure.|||days||Standard Deviation|Mean
2572264|NCT02509078|Primary|Hospital Mortality to Day 90|The percentage of subjects alive at study day 90. Those subjects discharged home prior to day 90 were counted as alive at day 90.|90 days after randomization||||Participants|||Count of Participants
2572265|NCT02509065|Secondary|Total Glucagon Dosing by the Bihormonal Bionic Pancreas From the Start of Exercise Until the End of the Visit|During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes|Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)||||mcg/kg||Standard Deviation|Mean
2572266|NCT02509065|Secondary|Grams of Carbohydrates Given to the Subject to Treat Hypoglycemia|During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes|Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)||||grams of carbohydrates||Standard Deviation|Mean
2572267|NCT02509065|Secondary|Time From Start of Exercise to First CGM Measurement < 60 mg/dl|During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes|Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)||||minutes||Standard Deviation|Mean
2572268|NCT02509065|Secondary|Time From Start of Exercise to First BG Measurement < 60 mg/dl|During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes|Day 4 in-clinic Exercise Visit (type 1 diabetes only, 110 and 130 mg/dl arms only)||||minutes||Standard Deviation|Mean
2572269|NCT02509065|Secondary|Area Between the Glucose Curve and 60 mg/dl Calculated From CGM Measurements|CGM glucose values to create this curve included time points from time 0 to a maximum of 360 minutes, with a sampling frequency of every 5 minutes|Day 4 in-clinic Exercise Visit (type 1 diabetes only, 110 and 130 mg/dl arms only)||||min*mg/dl||Standard Deviation|Mean
2572270|NCT02509065|Secondary|Area Between the Glucose Curve and 60 mg/dl Calculated From BG Measurements|Plasma glucose values to create this curve included time points from time 0 to a maximum of 360 minutes, with a sampling frequency of at least every 10 minutes throughout.|Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)||||min*mg/dl||Standard Deviation|Mean
2572271|NCT02509065|Secondary|Percentage of Subjects With Mean CGM < 154 mg/dl|The percentage of subjects who's mean CGM glucose level is < 154 mg/dl, which is an estimated hemoglobin a1c < 7%, which is the ADA goal for therapy|Days 2-3||||Participants|||Count of Participants
2572272|NCT02509065|Secondary|Percentage of Time Spent in: < 50 mg/dl, < 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, >250 mg/dl|The fraction of time spent in each of these ranges according to continuous glucose monitor readings|Days 2-3||||percentage of time||Standard Deviation|Mean
2572273|NCT02509065|Secondary|Nausea Severity|The average severity of nausea, as recorded on a 10 centimeter visual analog scale by the daily e-mail survey they receive. Scores were determined by how many centimeters the subject marked as a surrogate for their nausea level on a daily basis. Any value more than 0 cm indicates some degree of nausea with a score of 10 cm being the worst nausea imaginable. A score less than 3 cm indicates a mild level of nausea.|Days 1-3||||scores on a scale 0-10 cm||Standard Deviation|Mean
2572274|NCT02509065|Secondary|Mean CGM Glucose|Average glucose according to continuous glucose monitor readings including the 1 day washout|Days 1 through 3||||mg/dl||Standard Deviation|Mean
2572275|NCT02509065|Primary|Number of Subjects Discordant for Reaching a BG < 60 mg/dl for > 2 Consecutive Plasma Glucose Measurements During Inpatient Exercise Visit|During both 110 mg/dl and 130 mg/dl arms, subjects will report for a fasted in-clinic exercise visit, with plasma blood glucose measurements obtained at least every 10 minutes|Day 4 in-clinic Exercise Visit (110 and 130 mg/dl arms only)||||Participants|||Count of Participants
2572959|NCT02500368|Secondary|Corneal Staining (Extent)|"Corneal staining extent, grade as % of each zone:~C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior"|Baseline and 1 week||||percentage of cornea||Standard Deviation|Mean
2572276|NCT02509065|Primary|Percentage of Time With CGM < 60 mg/dl|For this calculation we analyzed data from every 5 minutes of CGM data for days 2 and 3 of each study arm. We looked specifically at the percentage time of those roughly 48 hours that had any glucose values less than 60 mg/dl. The final value presented is the percent of time per 2 days of the study arm spent in a specific hypoglycemia range of less than 60 mg/dl with an associated standard deviation.|Days 2 and 3||||percentage of time||Standard Deviation|Mean
2572277|NCT02509065|Primary|Mean Continuous Glucose Monitor (CGM) Glucose Values|Glucose values were collected from the Dexcom G4 CGM device every 5 minutes and an average (calculated mean with associated standard deviation) CGM glucose level (mg/dl) was calculated from days 2 and 3 of the study arm.|Days 2 and 3||||mg/dl||Standard Deviation|Mean
2572278|NCT02508935|Primary|Time of Maximum Observed Plasma Concentration (Tmax)|The time at which the maximum plasma concentration (Cmax) is reached.|within approximately 12 hours (12.08 hours)|PK population.|||hour||Full Range|Median
2572279|NCT02508935|Primary|Apparent Plasma Terminal Drug Elimination Half-life (T1/2)|PK parameters are determined after a single administration of study drug on Day 1. Plasma concentrations that are below the level of quantification (BLQ) are set to 0 before Tmax, with the exception that a BLQ value occurring between measurable concentrations is set to missing. BLQ values that occur after Tmax are set to missing.|within approximately 12 hours (12.08 hours)|PK population with BLQ values set to missing|||hours||Full Range|Median
2572280|NCT02508935|Primary|Maximum Observed Plasma Concentration (Cmax)|The highest concentration of study drug within 12 hours.|within approximately 12 hours (12.08 hours)|PK population.|||ng/mL||Standard Deviation|Mean
2572281|NCT02508935|Primary|Area Under the Concentration-time Curve (AUC) From Time Zero (AUC0) to the Time of the Last Quantifiable Plasma Sample (AUClast)|Elimination constant estimates required for the calculation of the planned AUC0-12 hours were not available. AUClast therefore provided the best available measure of exposure, effectively representing AUC0-12 hours for both moieties. While considered the best available measure, it also remains inaccurate because of the extended-release formulation and the lack of data beyond the 12.08-hour time point.|within approximately 12 hours (12.08 hours)|PK population|||ng*hr/mL||Full Range|Median
2572282|NCT02508935|Primary|Time to Reach Steady State|The time to reach steady state in participants who received all 5 doses|within 60 hours|Steady-state pharmacokinetic (PK) parameters were to be determined for those participants administered all 5 doses. However, no participant received all 5 doses; therefore, steady state PK parameters were not derived.||||||
2572283|NCT02508701|Secondary|Number of Participants With 3rd Uptake Shots|The Number of Participants with 3rd Uptake Shots|6 months|Study data on this outcome was not collected because study was terminated||||||
2572284|NCT02508701|Secondary|Number of Participants With Second Uptake Shot||6 months|Data was not collected because study was terminated.||||||
2572285|NCT02508701|Primary|Number of Participants With 1st Uptake Shot|The Number of Participants with 1st Uptake Shot|6 months||||Participants|||Count of Participants
2572286|NCT02508701|Primary|Number of Participants With 1st Uptake Shots|Number of Participants with the 1st Uptake Shots|Up to 12 months|Frequency|||participants|||Number
2572287|NCT02508480|Secondary|Personal Growth and Recovery Scale, Change in Perceptions of Growth and Recovery|This is a 16-item, 4 point scale (1 to 4) developed for a previous Photovoice study. Items tap aspects of a person's psychosocial functioning and recovery. Internal consistency is 0.94 and retest reliability is .79. The scale score is the average of scores on each item with higher scores indicating higher levels of recovery.|Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment|The participants included in analysis at each time point are those who completed the measure at that time point.|||Score on a scale.||Standard Deviation|Mean
2572288|NCT02508480|Secondary|Maryland Assessment of Recovery, Change in Perceptions of Recovery|is a 25-item, 5-point (1 to 5) scale that assesses a person's sense of recovery from mental illness across a variety of dimensions. Internal consistency is.95 and test-retest reliability is .89). The scale score is the average score on each item with higher scores indicating higher levels of recovery.|Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment|Participants included in the analysis at each time point are those who completed the measure at that timepoint.|||Score on a scale.||Standard Deviation|Mean
2572289|NCT02508480|Secondary|Scales of Psychological Well-Being, Change in Well-being|"This is a 54-item, 6-point (1 to 6) measure rating wellbeing (from strongly disagree to strongly agree) including subscales of mastery, personal growth, purpose in life, self-acceptance, autonomy and positive relations with others. Internal consistency is .94. It has been successfully used with individuals with SMI. Higher scores indicate greater well-being.~Each subscale score is the average of the scores on included items. We present below the scores on the self-acceptance subscale."|Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment|The participants included in analysis at each time point are those who completed the measure at that time point.|||Score on a scale.||Standard Deviation|Mean
2572290|NCT02508480|Secondary|Brief Psychiatric Rating Scale, Change in Psychiatric Symptoms|This is a 24-item scale that rates the severity of a variety of psychiatric psychotic symptoms, positive and negative symptoms on a 7-point scale of 1 (absent) to 7 (severe). The scale score is the mean of the score on all items, ranging from 1 to 7.|Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment|The number analyzed at each time point represent the number who completed the assessment at that time point.|||Score on a scale.||Standard Deviation|Mean
2572291|NCT02508480|Primary|Temple University Community Participation Scale, Change in Community Participation|"is a 26 item instrument measuring frequency of participation and importance of various community activities (e.g., movies, library). Test-retest reliability is .7 and internal consistency is .9. Higher scores are better.~We provide below the results for cumulative days of participation in the last 30 days across the 26 activities included in the measure (tcpm_days_participated). The possible range for this measure is 0-780."|Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment|Participants included in the analysis at each time point are those who completed the questionnaire at that time point.|||Days of participation||Standard Deviation|Mean
2572305|NCT02508207|Secondary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 28|Percent predicted FEV1 is the ratio of FEV1 to the predicted FEV1, expressed as a percentage. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Day 28|The FAS was used.|||percentage of predicted FEV1||Standard Deviation|Mean
2572292|NCT02508480|Primary|Heinrich's Quality of Life Scale-Client Version, Change in Quality of Life|"This is a 21 item, semi-structured interview-based, rating of an individual's psycho-social functioning and satisfaction with various life domains. The score on each item ranges from 0-6 with higher scores indicating better functioning. The subscale scores are computed based on the average score of items included.~We report below on the interpersonal functioning and intrapsychic foundations subscales."|Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment|Participants included in the analysis at each time point are participants who completed the measure at that time point.|||Score on a scale.||Standard Deviation|Mean
2572293|NCT02508480|Primary|The Stigma Scale, Change in Perceptions of Stigma|is a 28 item, 5 point scale ranging from 0-4 (strongly disagree to strongly agree) measuring experienced and anticipated stigma. Internal consistency ranges from .85-.87 and test-retest reliability from .4 to .7. The scale score is the average score on all items. Lower scores are better.|Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment|Participants included in the analysis at each time point are those who completed the scale at that time point.|||score on a scale||Standard Deviation|Mean
2572294|NCT02508480|Primary|Approaches to Coping With Stigma, Change in Coping With Stigma|is a 27-item, 4-point scale ranging from 1-4 (strongly disagree to strongly agree) measuring strategies to cope with stigma: secrecy, withdrawal, distancing, educating others, and challenging others. The average score of the items in the first three subscales will represent the index for Avoidant Coping and the average score of the items in the last two subscales - the index for Proactive Coping with Stigma. Internal consistency for subscales range: .63-.84. Lower scores are better on Avoidant Coping and higher scores are better on Proactive Coping.|Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment|Participants included in analysis at each time point are those who completed the scale at that time point.|||score on a scale||Standard Deviation|Mean
2572295|NCT02508480|Primary|Internalized Stigma of Mental Illness Scale, Change in Internalized Stigma|"a 29-item, 4-point scale (strongly disagree to strongly agree) assesses behaviors, thoughts and feelings that are self-stigmatizing and includes alienation, stereotype endorsement, discriminatory experiences, social withdrawal, and stigma resistance subscales. Internal consistency is .9 and test-retest reliability is .92. Lower scores are better.~The scale score is the average score on the 29 items, which are scored from 1-4. Lower scores signify less internalized stigma."|Baseline, post-treatment, 3 months post-treatment, 6 months post-treatment|Participants included in analysis at each time point are those who completed the scale at that time point.|||Score on a scale.||Standard Deviation|Mean
2572296|NCT02508259|Secondary|Repetitive Behavior Questionnaire|Total repetitive behavior was assessed using the Repetitive behavior questionnaire (RBQ), which has a scale from 0-87. Higher scores correspond to more severe repetitive behavior. Outcomes were analyzed as the difference in the score 6 weeks after treatment compared to baseline. A negative difference corresponds to improved behavior compared to baseline. A positive difference corresponds to worse behavior.|6 weeks compared to baseline|Subjects receiving suramin or saline.|||units on a scale||Standard Deviation|Mean
2572297|NCT02508259|Secondary|The Clinical Global Impression - Improvement Scale (CGI-I)|The CGI-I is scale that ranges from 1-7, reflecting the change in core autism behaviors after treatment. 1 is much improved, 4 is unchanged, and 7 is much worse.|Overall ASD symptoms at 6 weeks|Subjects receiving either suramin or saline.|||units on a scale||Standard Deviation|Mean
2572298|NCT02508259|Secondary|Autism Treatment Evaluation Checklist (ATEC)|The reported value is the Language sub-score of the ATEC, and the range for the language sub-score is 0-20. The higher the score, the worse the disability. Outcomes were measured at 6 weeks after treatment compared to baseline. A negative difference corresponds to a decrease in language disability, i.e an improvement in speech and language. A positive difference reflects an increase in language disability, i.e. a decrease in speech and language.|6 weeks|Subjects receiving either suramin or saline.|||units on a scale||Standard Deviation|Mean
2572299|NCT02508259|Secondary|Aberrant Behavior Checklist (ABC)|The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. Stereotypy is reported, and scores range from 0 to 21, with higher scores indicating worse behavior. A negative difference corresponds to decreased symptoms after treatment. A positive difference corresponds to increased symptoms after treatment.|6 weeks compared to baseline|Subjects receiving either suramin or saline.|||units on a scale||Standard Deviation|Mean
2572300|NCT02508259|Primary|Expressive Language|Expressive One Word Picture Vocabulary Test (EOWPVT) scores are normalized for age. Typical language development produces a mean score of 100 with a standard deviation of 15. Outcomes for EOWPVT were expressed as the mean of the child-specific difference before and 6-weeks after treatment. For example, if the 6-week standard EOWPVT score was 59.6 and the baseline score was 63.8, the difference is -4.2 (= 59.6 - 63.8). A decrease in score at 6 weeks would corresponds to a decrease in language performance, while an increase, a positive difference, would reflect an increase.|6 weeks compared to baseline|Subjects receiving either suramin or saline.|||units on a scale||Standard Deviation|Mean
2572301|NCT02508259|Primary|Autism Diagnostic Observation Schedule, 2nd Edition (ADOS2)|ADOS2 comparison scores are units on a scale of 0-10. A score of 7-10 was required for enrollment. A score of 7-10 is diagnostic for autism spectrum disorder (ASD). The higher the score, the more severe the core symptoms of autism spectrum disorder. Scores of 6 and below are considered off the ASD spectrum.|6 weeks compared to baseline|Patients receiving either suramin or saline.|||units on a scale||Standard Deviation|Mean
2572302|NCT02508207|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)||Baseline up to Day 57|The Safety Set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2572303|NCT02508207|Secondary|Absolute Change From Baseline in Sweat Chloride at Day 29||Baseline, Day 29|The FAS was used. Here, “Overall Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||millimoles per liter||Standard Deviation|Mean
2572304|NCT02508207|Secondary|Absolute Change From Baseline in Small-bowel Area Under the Curve (AUC) Over 1-minute Mean pH Increments at Day 29|Absolute change from Baseline in small bowel AUC over 1-minute mean pH increments through 30 minutes at Day 29 was assessed.|Baseline, Day 29|"The FAS was used. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."|||pH minutes||Standard Deviation|Mean
2572960|NCT02500368|Secondary|Corneal Dehydration Staining|Corneal Staining: Dehydration Staining: Yes/No|1 week||||participants|||Number
2572306|NCT02508207|Primary|Absolute Change From Baseline in Mucociliary Clearance (MCC) at Day 28|MCC was assessed using an imaging technique that enables the tracking of mucus within the airways. MCC was expressed as the percentage of whole-lung clearance through 60 minutes at Baseline and Day 28.|Baseline, Day 28|The Full Analysis Set (FAS) included all randomized participants who carry the relevant cystic fibrosis transmembrane conductance regulator (CFTR) allele and received at least 1 dose of study drug.|||percentage of whole-lung clearance||Standard Deviation|Mean
2572307|NCT02508194|Secondary|Number of Participants With Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent New Onset Chronic Disease (NOCDs)|An serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and approximately 1 year follow up that were absent before treatment or that worsened relative to pretreatment state. An adverse event of special interest was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor. A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving study drug and was assessed by investigator as medically significant. The Season 1 was approximately 1 year.|Day 1 (post-dose) through end of Season 1 (approximately 1 year)|ATP: Participants who received any dose of IP. Participants were included in the ATP according to the IP received even if different from that to which the participant was randomized.|||Participants|||Count of Participants
2572308|NCT02508194|Secondary|Number of Participants With Treatment-Emergent Adverse Events|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent events were between administration of study drug and Day 29 that were absent before treatment or that worsened relative to pre-treatment state.|Day 1 (post-dose) through Day 29|ATP: Participants who received any dose of IP. Participants were included in the ATP according to the IP received even if different from that to which the participant was randomized.|||Participants|||Count of Participants
2572309|NCT02508194|Secondary|Number of Participants With Any Solicited Symptoms|Solicited symptoms: tenderness or soreness at site of injection, pain at site of injection, fatigue or tiredness, headache, generalized muscle aches, swelling at the site of injection, redness at the site of injection, fever >= 100.4 degrees Fahrenheit by any route from Day 1 to Day 7.|Day 1 (post-dose) through Day 7|ATP: Participants who received any dose of investigational product (IP). Participants were included in the ATP according to the IP received even if different from that to which the participant was randomized.|||Participants|||Count of Participants
2572310|NCT02508194|Secondary|Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by a Palivizumab cELISA|Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Seroresponse was defined as a >= 3-fold rise of Serum Antibodies against RSV from baseline. The Season 1 was approximately 1 year.|Day 29 and End of Season 1 (approximately 1 year)|Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.||||||
2572311|NCT02508194|Secondary|Post-dose Geometric Mean Fold Change of Palivizumab Competitive Antibodies as Measured by a Palivizumab cELISA|"Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Geometric mean fold change was to be calculated as: anti-log2 [mean (log2 yi)], where yi is the post dose antibody concentration or T-cell count fold rise from baseline for each participant. The Season 1 was approximately 1 year."|Day 29 and End of Season 1 (approximately 1 year)|Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.||||||
2572312|NCT02508194|Secondary|Post-dose Geometric Mean Concentration (GMC) of Palivizumab Competitive Antibodies as Measured by a Palivizumab Competitive Enzyme Linked Immunosorbent Assay (cELISA)|"Palivizumab cELISA assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. GMC was to be calculated as: anti-log2 [mean (log2 xi)], where xi is an antibodies concentration of participants. The Season 1 was approximately 1 year."|Day 29 and End of Season 1 (approximately 1 year)|Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.||||||
2572313|NCT02508194|Secondary|Percentage of Participants Who Had a Post-dose Seroresponse to RSV by Microneutralization Assay|Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Seroresponse was defined as a >= 3-fold rise of Serum Antibodies against RSV from baseline. The Season 1 was approximately 1 year.|Day 29 and End of Season 1 (approximately 1 year)|Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.||||||
2572314|NCT02508194|Secondary|Post-dose Geometric Mean Fold Change of Serum Antibodies Against RSV by Microneutralization Assay|"Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. Geometric mean fold change was to be calculated as: anti-log2 [mean (log2 yi)], where yi is the post dose antibody concentration or T-cell count fold rise from baseline for each participant. The Season 1 was approximately 1 year."|Day 29 and End of Season 1 (approximately 1 year)|Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.||||||
2572315|NCT02508194|Secondary|Post-dose GMTs of Serum Antibodies Against RSV by Microneutralization Assay|"Microneutralization assay was to be used to assess humoral immunity (HAI antibody titers) against RSV. GMT was to be calculated as: anti-log2 [mean (log2 xi)], where xi is an antibodies concentration of participants. The Season 1 was approximately 1 year."|Day 29 and End of Season 1 (approximately 1 year)|Data for this outcome measure were not collected as the study was terminated prematurely because the study did not meet its primary efficacy outcome measure.||||||
2572316|NCT02508194|Secondary|Percentage of Participants Who Had a Strain-specific Post-dose Seroresponse to HAI Antibody|Seroresponse was defined as a >= 4-fold rise of strain-specific HAI antibodies (H1N1, H3N2, B BRISBANE, and B PHUKET) from baseline. The Season 1 was approximately 1 year.|Day 29 of Season 1|Immunogenicity population for IIV: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to the influenza vaccine.|||Percentage of Participants|||Number
2572317|NCT02508194|Secondary|Post-dose Geometric Mean Fold Change of Strain-Specific HAI Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine|"Geometric mean fold change was calculated as: anti-log2 [mean (log2 yi)], where yi is the post dose antibody concentration or T-cell count fold change from baseline for each participant. Geometric mean fold change of strain-specific HAI antibodies (H1N1, H3N2, B BRISBANE, and B PHUKET) were reported. The Season 1 was approximately 1 year."|Day 29 of Season 1|Immunogenicity population for IIV: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to the influenza vaccine.|||Fold Change||95% Confidence Interval|Geometric Mean
2572318|NCT02508194|Secondary|Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition (HAI) Antibodies to Influenza Antigens Contained in the Seasonal Influenza Vaccine|"GMT was calculated as: anti-log2 [mean (log2 xi)], where xi is an antibodies concentration of participants. GMTs of strain-Specific HAI antibodies (H1N1, H3N2, B Brisbane, and B Phuket) were reported. The Season 1 was approximately 1 year."|Day 1 (post-dose) and Day 29 of Season 1|Immunogenicity population for IIV: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to the influenza vaccine.|||Titer||95% Confidence Interval|Geometric Mean
2572319|NCT02508194|Secondary|Percentage of Participants Who Had a Post-dose Seroresponse to RSV as Measured by Anti-F IgG Assay|Anti-F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. Seroresponse was defined as a greater than or equal to (>=) 3-fold rise of serum antibodies against RSV from baseline. The Season 1 was approximately 1 year.|Day 29 and End of Season 1 (approximately 1 year)|Immunogenicity population for MEDI7510: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to MEDI7510.|||Percentage of Participants||95% Confidence Interval|Number
2572320|NCT02508194|Secondary|Geometric Mean Fold Change of Serum Antibodies Concentration Against RSV by Anti-F IgG Assay|"Anti-F IgG antibodies concentration was determined by a multiplex IgG assay developed on the Meso Scale discovery platform. It was calculated as: anti-log2 [mean (log2 yi)], where yi is the post dose antibody concentration or T-cell count fold change from baseline for each participant. The Season 1 was approximately 1 year."|Day 29 and End of Season 1 (approximately 1 year)|Immunogenicity population for MEDI7510: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to MEDI7510.|||Fold Change||95% Confidence Interval|Geometric Mean
2572321|NCT02508194|Secondary|Geometric Mean Responses (GMRs) of Serum Antibodies Concentration Against RSV by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay|"Anti-F IgG antibodies concentration were determined by a multiplex IgG assay developed on the Meso Scale discovery platform. It was calculated as: anti-log2 [mean (log2 xi)], where xi is an antibodies concentration of participants. The Season 1 was approximately 1 year."|Day 1, Day 29, and End of Season 1 (approximately 1 year)|Immunogenicity population for MEDI7510: All participants in the ATP who had no major protocol deviations judged to have the potential to interfere with the generation or interpretation of an immune response to MEDI7510.|||Fragment antigen-binding (F AB) unit/mL||95% Confidence Interval|Geometric Mean
2572322|NCT02508194|Secondary|Percentage of Participants Who Had a RSV Polymerase Chain Reaction (PCR)-Positive Respiratory Illness During the RSV Surveillance Period in Season 1|Detection of RSV was done by PCR method by using any respiratory sample. The incidence of RSV PCR-positive respiratory illness during the RSV surveillance period was evaluated. The surveillance period was approximately 7 months and Season 1 was approximately 1 year.|Day 14 after dosing through end of surveillance period (approximately 7 months)|Per-protocol population: All participants in the ATP who were followed for qualifying symptoms for RSV until the end of the RSV surveillance period. Participants who met the primary endpoint criteria and were not followed until the end of the RSV surveillance period were also included in the per-protocol population.|||Percentage of Participants|||Number
2572323|NCT02508194|Primary|Percentage of Participants Who Had a First Episode of Acute Respiratory Syncytial Virus-Associated Respiratory Illness (ARA-RI) During Respiratory Syncytial Virus (RSV) Surveillance Period in Season 1|ARA-RI was defined as an event in which a participant met specified clinical criteria and the event was laboratory-confirmed to be RSV‑related. The specified clinical criteria included a minimum of 1 symptom from any 2 of the 3 symptom columns: one symptom from upper respiratory symptom column and one symptom from lower respiratory symptom column; one symptom from upper respiratory symptom column and one symptom from systemic symptom column; or one symptom from lower respiratory column and one from systemic symptom column and laboratory confirmation of RSV on at least 1 sample obtained between Day 1 to Day 8 of illness. The surveillance period was approximately 7 months and Season 1 was approximately 1 year.|Day 14 after dosing through end of surveillance period (approximately 7 months)|Per-protocol population: All participants in the as-treated population (ATP) who were followed for qualifying symptoms for RSV until the end of the RSV surveillance period. Participants who met the primary endpoint criteria and were not followed until the end of the RSV surveillance period were also included in the per-protocol population.|||Percentage of Participants|||Number
2572324|NCT02508116|Secondary|Number of Participants With Bleeding Events|"major bleeding events defined by the Bleeding Academic Research Consortium (BARC) type 3 or 5.~Type 3= Overt bleeding requiring: blood transfusion, surgical intervention or intravenous vasoactive agents; cardiac tamponade; intracranial hemorrhage; intraocular bleeding.~Type 5= fatal bleeding"|1 year||||Participants|||Count of Participants
2572325|NCT02508116|Secondary|Number of Participants With Major Cardiac Events|major cardiac events defined as occurrence of first myocardial infarction, ischemic stroke, cardiovascular death, stent thrombosis, or need for urgent revascularization|1 year|Intent to treat|||Participants|||Count of Participants
2572326|NCT02508116|Secondary|Number of Participants With Drug Orders in Agreement With the Genotype-guided Recommendations|Agreement to suggested treatment recommendations based on genotype. The agreement rate was defined as the number of participants in genotyped group with loss of function variants that received prasugrel or ticagrelor + the number of participants without these variants that received clopidogrel divided by the total number in this group.|for up to 7 days after PCI|Subjects with genotype data available|||Participants|||Count of Participants
2572961|NCT02500368|Secondary|Limbal Hyperemia|Limbal hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2572328|NCT02508103|Primary|Amygdala Response to Cognitive-emotional Processing Task During Functional Magnetic Resonance Imaging (fMRI)|"During fMRI scanning, the investigators will assess the effects of intranasal oxytocin (vs. placebo) on amygdala response to cognitive-emotional processing task (Hariri et al., 2006) during the late luteal phase of two consecutive menstrual cycles. Amygdala reactivity was assessed by extracting a contrast of parameter estimate (COPE) for each region (left and right amygdala). Regions were defined using binarized Harvard-Oxford Subcortical Atlas masks. The parameter estimate was the average estimate of all voxels in each region for the task contrast of viewing Faces vs. Shapes. We used neuroimaging software package FSL to calculate and extract these parameter estimates."|1 hour of scanning during the late luteal phase of two consecutive menstrual cycles||||parameter estimate||Standard Deviation|Mean
2572329|NCT02508103|Primary|Change in Premenstrual Symptom Severity|"The investigators will analyze premenstrual symptom severity ratings during the late luteal phase of two consecutive menstrual cycles to assess the effects of intranasal oxytocin (vs. placebo) on premenstrual symptom severity. Daily premenstrual symptoms were measured using the Daily Record of Severity of Problems (DRSP; Endicott et al., 2006). Across 24 items representing emotional, physical, and behavioral symptoms, participants indicated the degree to which the problems have been experienced today: 1—Not at all, 2—Minimal, 3—Mild, 4—Moderate, 5—Severe, or 6—Extreme. For each participant, we calculated a total score by summing all 24 items. We then calculated a mean total score for each condition by averaging all participants total scores in a given condition. Higher scores represent greater symptoms. Range of total score is 24 to 144."|During the late luteal phase of two consecutive menstrual cycles (an average of 3-5 days of treatment)||||units on a scale||Standard Deviation|Mean
2572330|NCT02508077|Primary|4-month Progression-free Survival (PFS) Rate|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Will be estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including baseline sum), or a measurable increase in a non-target lesion, or the appearance of new lesions.|At 4 months||||percentage of participants|||Number
2572331|NCT02507973|Primary|Intracranial Pressure|We aim to evaluate the patients during the two modes of ventilation (LTOV and APRV) to determine if there are significant differences in their ICP based on ventilation mode.|On average, 24 hours for each patient|"Access to original intracranial pressure data lost and cannot be summarized~No data was analyzed to report."||||||
2572332|NCT02507752|Secondary|Percentage of Participants Achieving a Clinically Important Increase of >=5 Points in the SF-36 Physical and Mental Component Scores at Weeks 12 and 24.|SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.|Week 12 and 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = number of participants analyzed for a given component of SF-36.|||Percentage||95% Confidence Interval|Number
2572333|NCT02507752|Secondary|Percentage of Participants Achieving a Clinically Important Reduction of >= 0.22 Point in HAQ Score at Week 12.|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The proportion of participants achieving a clinically important reduction of >= 0.22 point in HAQ (disease-specific questionnaire) at Week 24 was evaluated. HAQ was assessed using the set of observed cases (OC) at each assessment time. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.|Week 12|The ITT population included all screened participants who answered at least one SF-36 questionnaire.|||Percentage||95% Confidence Interval|Number
2572334|NCT02507752|Secondary|Change in SF-36 Domain Scores From Screening to Week (Wk) 12 and 24|SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed for a particular domain of SF-36.|||scores on a scale||Standard Error|Mean
2572335|NCT02507752|Secondary|Change in SF-36 Physical and Mental Component Scores From Screening to Week 12|SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.|Baseline, Week 12|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed for a particular component of SF-36.|||scores on a scale||Standard Error|Mean
2572962|NCT02500368|Secondary|Bulbar Hyperemia|Bulbar hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2572336|NCT02507752|Secondary|Change in Pain Scale (100-mm VAS) From Screening to Weeks 12 and 24|Visual Analogue Scale (VAS) is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change from Screening=scores at observation minus score at Screening. An increase in score from Screening represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. The change in pain scale was analyzed for the set of observed cases (OC) at each assessment time.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.|||Units on a scale||Standard Error|Mean
2572337|NCT02507752|Secondary|Change in HAQ Score From Screening to Weeks 12 and 24|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The number of participants achieving a clinically important reduction of >= 0.22 point in HAQ (disease-specific questionnaire) at Week 24 was evaluated. HAQ was assessed using the set of observed cases (OC) at each assessment time. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.|||Units on a scale||Standard Error|Mean
2572338|NCT02507752|Secondary|Mean Change From Baseline in Patient Global Assessment (100 mm VAS)|"The Physician's Global Assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity).Change from Baseline = scores at observation minus score at Baseline. An increase in score from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement."|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.|||Units on a scale||Standard Error|Mean
2572339|NCT02507752|Secondary|Mean Change From Baseline in Disease Activity Score 28 Joints (DAS28) Score|DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.|||Units on a scale||Standard Error|Mean
2572340|NCT02507752|Secondary|Mean Change From Baseline in Tender Joint Count (TJC)|A tender joint count is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). It is associated more with the level of pain.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.|||Number of tender joints||Standard Error|Mean
2572341|NCT02507752|Secondary|Mean Change From Baseline in Swollen Joint Count (SJC)|A swollen joint count is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). It reflects the amount of inflamed synovial tissue.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.|||Number of swollen joints||Standard Error|Mean
2572342|NCT02507752|Secondary|Mean Change From Baseline in C-reactive Protein (CRP).|CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as Rheumatoid Arthritis.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.|||mg/L||Standard Error|Mean
2572343|NCT02507752|Secondary|Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Erythrocyte Sedimentation Rate is an acute phase reactant and a measure of inflammation.|Baseline, Week 12, Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = the number of participants analyzed at the given time point.|||mm/hr||Standard Error|Mean
2572344|NCT02507752|Secondary|Number of Participants With Infusion Reactions, Infectious Events and / or Other Adverse Events in the 24 Weeks After the Start of Treatment.|An infusion reaction is defined as an adverse event that occurs during infusion or within 24 hours after infusion of Rituximab. All infectious events, whether considered related or not to Rituximab, were collected for the safety analysis of the study. An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.|Up to 24 Weeks|The ITT population included all screened participants who answered at least one SF-36 questionnaire.|||participants|||Number
2572345|NCT02507752|Primary|Mean Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score at Week 24|SF- 36 investigates the standard of quality of life through a general health assessment and not specific to a particular disease, age or treatment group. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary. SF-36 was assessed using the set of observed cases (OC) at each assessment time.|Baseline and Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire. n = number of participants analyzed for a given component of SF-36.|||scores on a scale||Standard Error|Mean
2572346|NCT02507752|Primary|Percentage of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ) at Week 24|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. The proportion of participants achieving a clinically important reduction of >= 0.22 point in HAQ (disease-specific questionnaire) at Week 24 was evaluated. HAQ was assessed using the set of observed cases (OC) at each assessment time. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.|Week 24|The ITT population included all screened participants who answered at least one SF-36 questionnaire.|||Percentage||95% Confidence Interval|Number
2572347|NCT02507388|Secondary|Percentage of Subjects With Positive Anti-drug Antibody (ADA) Status (Test)|A positive ADA status is defined as induced ADA status with ADA negative at predose and with a post-dose titer value increase of 2 or more dilutions at any time point or boosted ADA status with ADA positive at predose and a post-dose titer value increase by more than 3-fold (1 dilution) at any time point.|Day 0 (predose), Day 28, Day 84|PK analysis set|||percentage of participants|||Number
2572348|NCT02507388|Primary|Concentration of RTH258 Obtained 24 Hours Post Day 56 Injection [C24hr (ng/mL)]|Serum concentration at the specified collection time point was quantitated, where possible, using a validated immunoassay method. The data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 57|PK analysis set|||ng/mL||Standard Deviation|Mean
2572349|NCT02507388|Primary|Concentration of RTH258 Obtained 24 Hours Post Day 0 Injection [C24hr (ng/mL)]|Serum concentration at the specified collection time point was quantitated, where possible, using a validated immunoassay method. The data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 1|PK analysis set|||ng/mL||Standard Deviation|Mean
2572350|NCT02507388|Primary|Elimination Half-life in Serum [t1/2 (h)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr|PK analysis set. Harmonic mean and jackknife estimate of the standard deviation are presented.|||hours||Standard Deviation|Mean
2572351|NCT02507388|Primary|Area Under the Concentration-time Curve From 0 to Infinity [AUC0-inf (ng*h/mL)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr|PK analysis set|||ng*h/mL||Standard Deviation|Mean
2572352|NCT02507388|Primary|Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC0-tlast (ng*h/mL)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr|PK analysis set|||ng*h/mL||Standard Deviation|Mean
2572353|NCT02507388|Primary|Time to Reach Maximum Analyte Serum Concentration [Tmax (h)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr|PK analysis set|||hours||Standard Deviation|Mean
2572354|NCT02507388|Primary|Maximum Analyte Serum Concentration [Cmax (ng/mL)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr|The PK analysis set included all subjects who received an intravitreal (IVT) injection with evaluable PK data and with no major protocol deviations that could have had an impact on the PK analysis.|||ng/mL||Standard Deviation|Mean
2572355|NCT02507375|Secondary|Volume of Distribution at Steady-state (Vss) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|Steady-state volume of distribution of a drug is an estimate of drug distribution independent of elimination processes. It is most useful for predicting the plasma concentrations following multiple dosing to a steady-state or pseudo-equilibrium. Vss is proportional to the amount of drug in the body versus the plasma concentration of the drug at steady state (pseudo-equilibrium). It is a calculated measure.|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|PK analysis subset|||Liters||Standard Deviation|Mean
2572356|NCT02507375|Secondary|Clearance (CL) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|A fundamental concept in pharmacokinetics is drug clearance (CL), that is, elimination of drugs from the body. The clearance is simply the ratio of the dose to the area under the curve (AUC), so that the higher the AUC for a given dose, the lower the clearance. If a drug is administered by continuous infusion and a steady state is achieved, the clearance can be estimated from a single measurement of the plasma drug concentration.|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|PK subset|||L/day||Standard Deviation|Mean
2572367|NCT02507349|Secondary|Sheehan Disability Scale|The Sheehan Disability Scale measures the extent to which three major sectors in the person's life are impaired by psychiatric symptoms (work/school, social/leisure life, and family/home life). The 3 items are summed together to form a single measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). Sheehan Disability Scale scores for each time point reflect the mean score of all measures collected within that time frame.|Baseline and every eight months during the two-year intervention phase|Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline|||Units on a scale|Survey Records|Standard Deviation|Mean
2572382|NCT02506881|Secondary|T1/2|Serum half-life of darbepoetin alfa after single sc of iv administration. Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis: patients who received at least one study drug injection.|||hours||Inter-Quartile Range|Median
2572357|NCT02507375|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With Non-small Cell Lung Cancer (NSCLC)|Bioavailability [AUC(0-t)] is a measure of how much of the drug reaches the person's bloodstream from time 0 (pre-dose) to a given time point (t) for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The Area Under the Curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour * nanograms (ng) per milliliter (mL), which equates to mg.day/L. Bioavailability Extrapolated to Infinity [AUC (0-inf)] is a calculated measure of how much of the drug will ever reach the person's bloodstream for the body to use. AUC (0-inf) stands for the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (forever). It is obtained from calculating AUC (0-t) plus AUC (t-inf).|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|Pharmacokinetic analysis subset with appropriate data available|||mg*day/L||Standard Deviation|Mean
2572358|NCT02507375|Secondary|Terminal Phase Plasma Half-life (t ½) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|Terminal phase plasma half-life (t ½) is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, rather than the time required to eliminate half the administered dose.|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|PK analysis subset with adequate data for this analysis|||days||Standard Deviation|Mean
2572359|NCT02507375|Secondary|Time of Cmax (Tmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|The time at which maximum concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, is reached (Tmax).|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|PK analysis subset|||days||Standard Deviation|Mean
2572360|NCT02507375|Secondary|Peak Plasma Concentration (Cmax) for Pertuzumab (Cycle 2) in the Presence of Erlotinib (at Steady-state) in Patients With NSCLC|Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, typically measured in nanograms/milliliter (ng/mL), reported as mg/L.|on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion|Pharmacokinetic analysis subset, defined as all participants from either cohort with adequate data for performing PK analysis|||mg/L||Standard Deviation|Mean
2572361|NCT02507375|Secondary|Percentage of Participants With a Complete Response or Partial Response at the End of Cycles 1, 2, 3, 4, and 6|Complete and partial responses were determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A complete response was defined as the disappearance of all target and non-target lesions. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter.|From baseline to the end of the study (up to 42 weeks)||||Percentage of participants|||Number
2572362|NCT02507375|Secondary|Percentage of Participants Classified as Responders|"Responders are participants who achieved either a complete response or a partial response according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. RECIST is a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment."|within 18 weeks|Full analysis set|||percentage of participants|||Number
2572363|NCT02507375|Primary|Percentage of Participants With Dose Limiting Toxicities (DLTs)|A DLT was defined as: Any non-hematological toxicity ≥ Grade 3 according to the Common Terminology Criteria for Adverse Events, version 3.0, except for fever, chills, and flu-like symptoms, which occurred despite adequate participant management. The following Grade 1-3 toxicities were exempt: Grade 1-3 skin and/or epithelial toxicities consistent with erlotinib single agent therapy, unless they did not respond to treatment or dose reduction or interruption (Grade 4 skin and/or epithelial toxicities were considered to be a DLT); Grade 4 neutropenia occurring for > 7 days; febrile neutropenia which occurred despite adequate participant management; Grade 4 thrombocytopenia or any thrombocytopenia requiring platelet transfusion; and any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds.|From baseline to end of the study (up to 42 weeks)||||Percentage of participants|||Number
2572364|NCT02507349|Secondary|Engagement in Psychotherapy Visit|Count of the number of psychotherapy visits for each study participant for the 12 month period prior to and including the anchor date of the time point.|Baseline, 8 months, 24 months|Based on participants who had available claims data.|||psychotherapy visits||Standard Deviation|Mean
2572365|NCT02507349|Secondary|Engagement in Medication and Evaluation Visit|Count of the number of medication checks and evaluation visits for each study participant for the 12 month period prior to and including the anchor date of the time point.|Baseline, 8 months, 24 months|Based on participants who had available claims data.|||medication checks and evaluation visits||Standard Deviation|Mean
2572366|NCT02507349|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (QLESQ-SF)|Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form is a 16-item, self-report questionnaire for assessing quality of life in multiple domains (e.g., physical health, mood, leisure time activities, social relationships, and overall). Response items are on a 5-point scale ranging from Very Poor to Very Good. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70. The raw total score was transformed into a percentage maximum possible score using the following formula. The lower values/percentages represent a poor outcome while higher values/percentages represent a better outcome. Overall possible range was 0-100. QLESQ-SF scores for each time point reflect the mean score of all measures collected within that time frame.|Baseline and every eight months during the two-year intervention phase|Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline|||Units on a scale|Survey Records|Standard Deviation|Mean
2572963|NCT02500368|Secondary|Overall Lens Fit|"Overall Lens Fit Scale 0-4, 0.25 steps 0=Very poor (lens should not be worn at all);~Poor (lens could be worn with supervision only);~Fair (would prefer to refit, but clinically acceptable);~Good (fit could be slightly improved);~Very good (optimal)"|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2572368|NCT02507349|Secondary|Behavior and Symptom Identification Scale (BASIS-24)|The BASIS-24 identifies a wide range of symptoms and problems that occur across the psychiatric diagnostic spectrum. There are 5 ordered responses either ranging from No Difficulty to Extreme Difficulty or from None of the Time to All of the Time. Each of 24 questions is scored on a 5 point scale (from 0 to 4 where 0 is the lowest severity and 4 is the highest). The overall BASIS-24 score is a weighted sum that is computed by multiplying the rating for each question by its weight and totaling the weighted ratings for each question. Overall possible range was 0 to 3.99. BASIS-24 scores for each time point reflect the mean score of all measures collected within that time frame.|Baseline and every eight months during the two-year intervention phase|Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline|||Units on a scale|Survey Records|Standard Deviation|Mean
2572369|NCT02507349|Secondary|Patient Activation Measure (PAM)|PAM is a 13-item scale that assesses the knowledge, skills, and confidence of patients essential to managing their own health and health care. Response options are: Strongly Disagree, Disagree, Agree, and Strongly Agree. The activation scale for the PAM ranges from 0 to 100. The lower values represent a poor outcome while higher values represent a better outcome. Overall possible range was 0 to 91.6. PAM scores for each time point reflect the mean score of all measures collected within that time frame.|Baseline and every eight months during the two-year intervention phase|Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline|||Units on a scale|Survey Records|Standard Deviation|Mean
2572370|NCT02507349|Secondary|Medication Side Effects|"Medication side effects will be assessed using a single question: How much is the patient troubled by medication side effects? Responses are on a scale of 1 through 10 with 1=Not Bothered at all by side effects and 10=Very Bothered by side effects. Medication side effect scores for each time point reflect the mean score of all measures collected within that time frame."|Baseline and every eight months during the two-year intervention phase|Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline|||Units on a scale|Survey Records|Standard Deviation|Mean
2572371|NCT02507349|Secondary|Hope|"Patient hopefulness will be assessed using a single question: Overall, how hopeful does the patient feel about his/her life? Responses are on a scale of 1 through 10 with 1=No Hope and 10=Filled with Hope. Hopefulness scores for each time point reflect the mean score of all measures collected within that time frame."|Baseline and every eight months during the two-year intervention phase|Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline|||Units on a scale|Survey Records|Standard Deviation|Mean
2572372|NCT02507349|Primary|Shared Decision Making Questionnaire (SDM-Q-9)|The SDM-Q-9 is a 9-item self-report measure of the degree of shared decision making in clinical encounters. There are 6 possible responses ranging from: Completely Disagree (0) to Completely Agree (5). Raw score ranges from 0 to 45. Multiplication of the raw score by 20/9 provides a score forced (transformed) to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of shared decision making in clinical encounters. SDM-Q-9 scores for each time point reflect the mean score of all measures collected within that time frame.|Baseline and every eight months during the two-year intervention phase|Multiple records can be measured from the same participant at the same time period, so N can be greater than the unique number of participants except for the baseline|||Units on a scale|Survey Records|Standard Deviation|Mean
2572373|NCT02507349|Primary|Patient Experience of Medication Treatment (PEMM)|The PEMM is a 12-item self-report measure of mental health patient experience of medication management with prescribers .Response options for 11 questions range from 0=Never to 4=Always, and the response options for the final question range from 0=Very Dissatisfied to 4=Very Satisfied. Overall possible range was 0 to 4. PEMM scores for each time point reflect the mean score of all measures collected within that time frame.|Baseline and every eight months during the two-year intervention phase|Multiple records can be measured from the same participant at the same time period, so overall number of surveys analyzed can be greater than the unique number of participants except for at baseline.|||Units on a scale|Survey Records|Standard Deviation|Mean
2572374|NCT02507219|Primary|Dose-dependent Differences in the BOLD Response to fMRI Tasks in the Amygdala|Change in amygdala activation following administration of placebo, 200mg of ibuprofen or 600mg of ibuprofen|3-6 weeks|Scans that had average Euclidean norm of motion parameters less than 0.15 were included in the analyses.|||percent signal change||Standard Error|Mean
2572375|NCT02506985|Primary|Change in Markers of NETosis at 30 Days Compared to Baseline|Values will be reported in comparison to baseline in the two treatment groups.|30 days|Sponsor terminated this study and withdrew funding prior to sample analysis. Therefore there was no funding to purchase assays to measure the collected samples nor was there enough samples to complete an assay.||||||
2572376|NCT02506985|Primary|Change in Markers of NETosis at 5 Days (or Day of Hospital Discharge) Compared to Baseline|Change in Markers of NETosis at 5 days (or day of hospital discharge) Compared to Baseline. Values will be reported in comparison to baseline in the two treatment groups.|5 days (or day of hospital discharge)|Sponsor terminated this study and withdrew funding prior to sample analysis. Therefore there was no funding to purchase assays to measure the collected samples nor was there enough samples to complete an assay.||||||
2572377|NCT02506985|Primary|Change in Markers of NETosis at 48h Compared to Baseline|Values will be reported in comparison to baseline in the two treatment groups.|48h|Sponsor terminated this study and withdrew funding prior to sample analysis. Therefore there was no funding to purchase assays to measure the collected samples nor was there enough samples to complete an assay.||||||
2572378|NCT02506985|Primary|Change in Markers of NETosis at 24h Compared to Baseline|Values will be reported in comparison to baseline in the two treatment groups.|24h|Sponsor terminated this study and withdrew funding prior to sample analysis. Therefore there was no funding to purchase assays to measure the collected samples nor was there enough samples to complete an assay.||||||
2572379|NCT02506985|Primary|Change in Markers of NETosis at 12h Compared to Baseline|Change in Markers of NETosis at 12h Compared to Baseline|12h|Sponsor terminated this study and withdrew funding prior to sample analysis. Therefore there was no funding to purchase assays to measure the collected samples nor was there enough samples to complete an assay.||||||
2572383|NCT02506881|Primary|AC-Emax|"Maximum elevation of absolute reticulocyte count from the baseline from the Moment of Drug Administration Until 504 hours.~Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose."|504 hours|Population for analysis of pharmacodynamics included patients who received at least one study drug injection.|||reticulocytes * 10^9/l||Inter-Quartile Range|Median
2572384|NCT02506881|Primary|AUEC|"Area Under Effect Curve (AUEC) of reticulocytes count from the Moment of Drug Administration Until 504 hours.~Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose."|504 hours|Population for pharmacokinetics analysis included patients who received at least one study drug injection.|||(reticulocytes * 10^9/l)*hour||Inter-Quartile Range|Median
2572385|NCT02506881|Primary|Cmax|"Maximal concentration of darbepoetin alfa From the Moment of Drug Administration Until 336 (sc administration) or 72 (iv administration) hours.~Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose."|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis included patients who received at least one study drug injection.|||pg/ml||Inter-Quartile Range|Median
2572386|NCT02506881|Primary|AUC|Area Under Concentration-time Curve (AUC) of Darbepoetin Alfa From the Moment of Drug Administration Until 336 (sc administration) or 72 (iv administration) Hours and to Infinity(AUC(0-336)/AUC(0-72) and AUC(0-∞) Respectively Blood samples were taken 30, 20, 10, 0 minutes before injection of study drug and then after 12, 24, 36, 72, 96, 144, 336 and 504 hours post-dose.|336 hours (sc) / 72 hours (iv)|Population for pharmacokinetics analysis: patients who received at least one study drug injection.|||(pg/ml)*hour||Inter-Quartile Range|Median
2572387|NCT02506868|Secondary|Number or Percentage of Patients With Binding and/or Neutralizing Antibodies Against Darbepoetin Alfa||Weeks 1 to 52|"The analysis included all patients who received at least one injection of BCD-066 or Aranesp - mITT population.~One patient from Aranesp group was excluded prior to the first administration."|||Participants|||Count of Participants
2572388|NCT02506868|Secondary|Number of Participants With Arterial and Venous Thrombotic Events||Weeks 1 to 52|"The analysis included all patients who received at least one injection of BCD-066 or Aranesp - mITT population.~One patient from Aranesp group was excluded prior to the first administration."|||Participants|||Count of Participants
2572389|NCT02506868|Secondary|Number of Participants Who Withdrew From Study Due to AE/SAE||Weeks 1 to 52|"The analysis included all patients who received at least one injection of BCD-066 or Aranesp - mITT population.~One patient from Aranesp group was excluded prior to the first administration."|||Participants|||Count of Participants
2572390|NCT02506868|Secondary|Number of Participants With Grade 3-4 AE/SAE||Weeks 1 to 52|"The analysis included all patients who received at least one injection of BCD-066 or Aranesp - mITT population.~One patient from Aranesp group was excluded prior to the first administration."|||Participants|||Count of Participants
2572391|NCT02506868|Secondary|Number of Patients With AE/SAE (AE/SAE Incidence)||Weeks 1 to 52|"The analysis included all patients who received at least one injection of BCD-066 or Aranesp - mITT population.~One patient from Aranesp group was excluded prior to the first administration."|||Participants|||Count of Participants
2572392|NCT02506868|Secondary|Mean Hematocrit Level During the Whole Study||Week 24||||percentage of hematocrit (%)||Standard Deviation|Mean
2572393|NCT02506868|Secondary|Mean Hemoglobin Level During the Whole Study (24 Week)|The outcome includes the measuere of Mean Hemoglobin Level During the Whole Study (during the study period from week 1 to week 24 week)|Week 24||||gram per liter||Standard Deviation|Mean
2572394|NCT02506868|Secondary|Mean Darbepoetin Alfa Dose During the Whole Study|The outcome includes the mean Darbepoetin Alfa Dose During the Whole Study|Week 24||||micrograms||Standard Deviation|Mean
2572395|NCT02506868|Secondary|Hemoglobin Level Dynamics||Weeks 1 to 24||||gram per liter||Standard Deviation|Mean
2572396|NCT02506868|Secondary|Number or Percentage of Patients With Hemoglobin Level Between 90 and 100 g/l||Weeks 21 to 24||||Participants|||Count of Participants
2572397|NCT02506868|Secondary|Mean Hemoglobin Level During Evaluation Period|The outcome includes the mean hemoglobin level which was registered in the patients during the last 4 weeks of the main period of the study (period from week 21 to week 24)|Week 24||||gram per liter||Standard Deviation|Mean
2572398|NCT02506868|Secondary|Number or Percentage of Patients With Need for 'Dose Titration' at the Beginning of the Study||Weeks 1 to 20||||Participants|||Count of Participants
2572399|NCT02506868|Secondary|Number or Percentage of Patients With Need for Blood Transfusions||Weeks 1 to 24||||Participants|||Count of Participants
2572400|NCT02506868|Secondary|Mean Darbepoetin Alfa Dose During Evaluation Period|The outcome includes the mean weekly dose of Darbepoetin Alfa which was administered to the patients during the period from week 21 to week 24 (last 4 weeks of the main period of the study)|Week 21 to Week 24||||micrograms||Standard Deviation|Mean
2572401|NCT02506868|Secondary|Number or Percentage of Patients Who Have Target Hemoglobin Concentration During Evaluation Period|Hb concentration between 100 and 120 g/l will be considered as target|Weeks 21 to 24||||Participants|||Count of Participants
2572402|NCT02506868|Primary|Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period||Baseline - measurements on Screening (weeks -4 - 0) and on day 1; Evaluation period - weekly measures on weeks 21 to 24||||gram per liter||Standard Deviation|Geometric Mean
2572403|NCT02506816|Secondary|Number of Participants With Olaparib-Associated Toxicities|To assess the tolerability for all treated patients (N=36) according to NCI-CTCAE v.4.03.|Up to 28 days (+/- 5)|The analysis was performed in the complete population of analysis (N = 36) and took in account patients who discontinued study for drug-associated toxicity.|||Participants|||Count of Participants
2572404|NCT02506816|Secondary|Plasma Levels of Olaparib|Plasma concentration of olaparib administered at dosis of 300mg twice in a day (600mg/day). Values of plasma level of olaparib on days 7,14,21 and 28 were collected at time when maximum of drug concentration is reached. Data are reported as µg/mL.|Days 7,14,21 and 28|The analysis was performed in the overall population of analysis (N = 36)|||µg/mL||Standard Deviation|Mean
2573326|NCT02496533|Secondary|Change in Blood Pressure in mmHg|A trained clinician will measure and record the subject's blood pressure using standard practices.|Baseline and After Imaging|All patients completing the study per protocol were included in the analysis.|||mmHg||Standard Deviation|Mean
2572405|NCT02506816|Secondary|Protein Expression of Biomarkers Related to PARP-inhibition|"We assessed the change from baseline in the H-score of several biomarkers targeted by olaparib-based therapy on endometrial tumor tissues after 28 (+/- 5) days of treatment. In detail, expression of protein involved in the DNA repair (PARP1, ɣH2AX), angiogenesis (VEG, HIF-1α, PTEN), apoptosis (p65, p50, p53), glucose metabolism (GLUT1), proliferation (PH3), and regulation of gene transcription (ARID1A) were evaluated by an H-score according to the following formula:~H-score= 1x(%light staining) + 2x(%moderate staining) + 3x(%strong staining).~The final score ranges from 0 to 300, where 0 indicates absence of staining and 300 the maximum staining."|Baseline and Day 28 (+/- 5)|The analysis was performed in the complete population of analysis (N = 36) and in the population of biomarkers (N = 31).|||score on a scale||Standard Deviation|Mean
2572406|NCT02506816|Primary|Expression of Cell Cycle-related Proteins|"We assessed the change from baseline in the histological score (H-score) of the cell cycle-related proteins on endometrial tumor tissues after 28 (+/- 5) days of olaparib-based therapy. In detail, expression of the cyclin D1, Ki67, and caspase-3 active proteins evaluated by an H-score according to the following formula:~H-score= 1x(%light staining) + 2x(%moderate staining) + 3x(%strong staining).~The final score ranges from 0 to 300, where 0 indicates absence of staining (corresponding to the lowest tumor proliferation rate and better outcome) and 300 the maximum staining (corresponding to the highest tumor proliferation score and worse outcome)."|Baseline and Day 28 (+/- 5)|The analysis was performed in the complete population of analysis (N = 36) and in the population of biomarkers (N = 31).|||score on a scale||Standard Deviation|Mean
2572407|NCT02506673|Secondary|Number of Participants With Complications|The percentage of patients who experienced complications (headache, transient neurologic symptoms, nausea and vomiting, ...)|Intraoperatively and in the recovery room, average of 3 hours||||Participants|||Count of Participants
2572408|NCT02506673|Secondary|Request of Sedation/Termination of AVA|Request of Sedation/Termination of AVA (After consent has been obtained until spinal resolution in the recovery room, average of 6 hours)|From consent until spinal resolution (avg 6 hs)|This outcome is only providing findings for subjects that has sedation and audiovisual aids with skin conductance monitor. It does not pertain to subjects that had sedation without the AVA.|||Participants|||Count of Participants
2572409|NCT02506673|Secondary|Number of Providers That Were Satisfied With Their Experience With the Audio-visual Aids|Anesthesia providers were asked to provide feedback on their experience with the audio-visual aids when the randomization was for the use of the device. This was collected upon surgery end.|Sent to providers at end of surgery.|Providers were only asked to provide feedback on the equipment when used by patients in the audiovisual aid group upon surgery end.|||Participants|||Count of Participants
2572410|NCT02506673|Secondary|Client Satisfaction Questionnaire (CSQ-8)|The client satisfaction questionnaire (CSQ-8) is a standardized satisfaction measure and was used to collect patient feedback on the audio visual devices. Response options differ, but all are on a 4-point scale. Scores range from 8 to 32, with higher values indicating higher satisfaction. Patient feedback (CSQ8) in PACU upon spinal resolution provider feedback (form sent to providers at end of surgery day)|PACU upon spinal resolution|This questionnaire was only administered to patients who used the audio-visual aids|||scores on a scale||Inter-Quartile Range|Median
2572411|NCT02506673|Secondary|Heidelberg Peri-anaesthetic Questionnaire|The questionnaire consists of 38 questions assessing perioperative satisfaction about five identified themes: trust and atmosphere; fear; discomfort; treatment by personnel; and information and waiting. The questions are rated on a 4-point Likert scale ranging from 0 (unimportant to me) to 3 (very important to me). Higher scores indicate higher levels of satisfaction. Patient satisfaction (Heidelberg Peri-Anaesthetic Questionnaire) in PACU upon spinal resolution.|At PACU upon spinal resolution.||||score on a scale||Standard Deviation|Mean
2572412|NCT02506673|Secondary|State-Trait Anxiety Inventory Questionnaire (STAI)|Questionnaire to measure state anixety levels based on a 4-point likert scale and consists of 40 questions. The questionnaire measures two types of anxiety: state anxiety and trait anxiety. State anxiety relates to anxiety about an event, while trait anxiety in anxiety level as a personal characteristic. Scores can range from 20 to 80 and higher scores correlate with more anxiety.|holding area and PACU|4-point likert scale and consists of 40 questions|||score on a scale||Standard Deviation|Mean
2572413|NCT02506673|Secondary|Narcotic Consumption|"Narcotic consumption intraop, postop and POD1"|Preop until 24 hours after surgery (holding area until POD 1)|POD1 - 13 patients from the AVA group were analyzed due to early discharge.|||oral morphine equivalents mg||Standard Deviation|Mean
2572414|NCT02506673|Secondary|Pain Numerical Rating Scale (NRS) Levels|Pain scores at rest will be collected from patients using the numerical rating scale (NRS), which asks patients to report their level of pain on a scale from 0 to 10, where 0 represents no pain and 10 represents the worst possible pain. NRS levels in holding area, PACU until discharge from the PACU and one day after surgery, postop day 1.|Holding area, Postop (PACU, 30 minutes after arrival to PACU and POD1)|Holding area, PACU arrival, 30 minutes after arrival to PACU and POD1.|||units on a scale||Standard Deviation|Mean
2572415|NCT02506673|Secondary|Number of Patients Who Requested Additional Sedation|Number of patients who requested additional sedative medication in the operating room.|In the operating room||||Participants|||Count of Participants
2572416|NCT02506673|Secondary|Respiratory Rate|The maxmimum change in postoperative respiratory rate from holding area until PACU discharge.|Measured from preop to postop|Some data was not available for all participants due to equipment not working or due to early discharge|||breaths/minute||Standard Deviation|Mean
2572417|NCT02506673|Secondary|Systolic and Diastolic Blood Pressure|The maximum change in postoperative systolic and diastolic blood pressure from holding area until PACU discharge.|Measured from preop to postop|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for baseline, intra op and post op was recorded.|||mmHg||Standard Deviation|Mean
2572418|NCT02506673|Secondary|Beats Per Minute (BPM)|The change in heart rate from holding area until PACU discharge.|Measured from preop to postop|Baseline has the heart rate number but analysis for intraop and postop is the change of the variable. Some patients were discharge earlier|||Beats Per Minute||Standard Deviation|Mean
2572610|NCT02504294|Secondary|Change From Baseline in Weekly Mean Study Medication Dose Over Final 8 Weeks of Study Treatment||Baseline (8 Weeks prior to randomization), Week 17 up to Week 24|"FAS included all participants who received at least 1 dose of study medication after randomization in to the study. Here, N signifies number of participants who were evaluable for this outcome measure."|||Units per week||Standard Error|Least Squares Mean
2572419|NCT02506673|Primary|Skin Conductance Response|Primary outcome will be number of skin conductance responses per second (SCR/sec) and amplitude of skin conductance responses averaged over time in 5 minute intervals and at key time points such before, during and after insertion of an IV, discussion with surgeon, anesthesiologist, immediately before leaving the holding area, immediately after entering the OR, during application of monitors, before and after administration of sedatives, before, during and after spinal insertion, incision, immediately prior to leaving the OR, after arrival at PACU and monitors are placed, before discharge from the PACU.|Measured in 5 minute intervals, from holding area until PACU discharge.|We had planned to use the Med-Storm Stress detector to measure skin conductance throughout the procedure until discharge. However, due to repeated technical difficulties with the device and inconclusive data from an analysis of a small number of patients data collection was stopped. No data are presented here.|||skin conductance responses per second||Standard Deviation|Mean
2572420|NCT02506660|Secondary|% of Participants Who Guessed the Correct Group|Patients will be asked whether they believe they were in the IV dexamethasone or intravenous dexamethasone group|Postoperative day 7-10||||% of participants||95% Confidence Interval|Number
2572421|NCT02506660|Secondary|Block-related Complications||Postoperative day 7-10||||patients with block complications|||Number
2572422|NCT02506660|Secondary|Block Satisfaction|0-10 scale (0=not satisfied; 10=extremely satisfied)|Postoperative day 2, postoperative day 3||||units on a scale||Standard Deviation|Mean
2572423|NCT02506660|Secondary|Side Effects|"Opioid-related symptom distress scale is calculated using responses to the symptom severity questions only.~For each symptom, severity is assessed by the question: (If yes), how severe was it usually? (In the past 24 hours) The responses to the severity questions are measured on a 5-point scale from 0-4 in ascending order as follows: Did not have symptom (0) Slight (1) Moderate (2) Severe (3) Very severe (4)"|Postoperative day 2, postoperative day 3||||units on a scale||Standard Deviation|Mean
2572424|NCT02506660|Secondary|Opioid Consumption||Postoperative day 2, postoperative day 3||||mg||Standard Deviation|Mean
2572425|NCT02506660|Secondary|Numerical Rating Scale Pain Scores|"The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable)"|Duration of stay in recovery room after surgery (average of 3 hours)||||Units on a Scale||Inter-Quartile Range|Median
2572426|NCT02506660|Primary|Nerve Block Duration|Time at which the pain relief from the block has completely worn off|Postoperative day 2+||||Hours||Inter-Quartile Range|Median
2572427|NCT02506634|Secondary|The Specificity of GERDQ for Diagnosis of GERD|"The specificity of GERDQ for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the gold standard for the diagnosis of GERD."|over 3 years|This outcome measure is the specificity of GERDQ for GERD diagnosis, so the whole analysis population would be patients who finished GERDQ. Note: typical reflux symptoms are heartburn and regurgitation; atypical reflux symptoms are chest pain, dysphagia, epigastric pain, epigastric burning, postprandial fullness, and early satiety.|||Percentage of true negative|||Number
2572428|NCT02506634|Secondary|The Sensitivity of GERDQ for Diagnosis of GERD|"The sensitivity of GERDQ for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the gold standard for the diagnosis of GERD."|over 3 years|This outcome measure is the sensitivity of GERDQ for GERD diagnosis, so the whole analysis population would be patients who finished GERDQ. Note: typical reflux symptoms are heartburn and regurgitation; atypical reflux symptoms are chest pain, dysphagia, epigastric pain, epigastric burning, postprandial fullness, and early satiety.|||Percentage of true positive|||Number
2572429|NCT02506634|Secondary|The Specificity of PPI Test for Diagnosis of GERD|"The specificity of PPI test for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the gold standard for the diagnosis of GERD."|over 3 years|This outcome measure is the specificity of PPI test for GERD diagnosis, so the whole analysis population would be patients who finished PPI treatment. Note: typical reflux symptoms are heartburn and regurgitation; atypical reflux symptoms are chest pain, dysphagia, epigastric pain, epigastric burning, postprandial fullness, and early satiety.|||Percentage of true negative|||Number
2572430|NCT02506634|Secondary|The Sensitivity of PPI Test for Diagnosis of GERD|"The sensitivity of PPI test for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the gold standard for the diagnosis of GERD."|over 3 years|This outcome measure is the sensitivity of PPI test for GERD diagnosis, so the whole analysis population would be patients who finished PPI treatment. Note: typical reflux symptoms are heartburn and regurgitation; atypical reflux symptoms are chest pain, dysphagia, epigastric pain, epigastric burning, postprandial fullness, and early satiety.|||Percentage of true positive|||Number
2572431|NCT02506634|Secondary|The Life Quality of GERD Patients Who Were Diagnosed by Either Reflux Esophagitis on Endoscopy or Positive Acid Exposure Time(AET) on Reflux Monitoring and Presented With Different Main Baseline Symptoms|The life quality of GERD patients with different main symptoms before PPI test will be measured via the MOS 36-item short form health survey (SF-36), in which higher scores mean a better quality of life. Its maximum score is 796.5, and the minimum score is 36.5.|over 3 years|The analysis population for this outcome measure was patients with a GERD diagnosis by either reflux esophagitis on upper endoscopy or positive acid exposure time(AET) on reflux monitoring.|||score on a scale||Standard Deviation|Mean
2572432|NCT02506634|Secondary|The Percentage of Participants Diagnosed With Pathological Acid Reflux Using Reflux Monitoring Among Participants With Different Main Baseline Symptoms|The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with different main baseline symptom in the symptom questionnaire in Chinese outpatients in Gastroenterology department will be calculated.|over 3 years|Among 374 enrolled patients presented with different main symptom, the percentage of patients with pathological acid reflux was calculated.|||Participants|||Count of Participants
2572433|NCT02506634|Secondary|The Percentage of Participants Diagnosed With Reflux Esophagitis Using Endoscopy Among Participants With Different Main Baseline Symptoms|The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with different main symptom in the symptom questionnaire in Chinese outpatients in Gastroenterology department will be calculated.|over 3 years|Among 374 enrolled patients presented with different main symptom, the percentage of patients with reflux esophagitis was calculated.|||Participants|||Count of Participants
2572434|NCT02506634|Primary|The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department|"GERD can be diagnosed by more than one different criteria (i.e.reflux esophagitis on endoscopy; positive acid exposure time (AET) on reflux monitoring;Either reflux esophagitis on endoscopy or positive AET on reflux monitoring) in a single participant. When different criteria was used to diagnose GERD, the percentage of GERD patients with different predominant symptom will be calculated. The symptom of the highest percentage will be the primary symptom."|over 3 years|GERD is diagnosed based on different criteria among 374 enrolled patients, and then the percentage of GERD patients with different predominant symptom will be calculated. The symptom of the highest percentage will be the primary symptom.|||Participants|||Count of Participants
2572435|NCT02506309|Secondary|Number of Participants With Major Postoperative Complications||four years||||participants|||Number
2572436|NCT02506309|Secondary|Number of Participants With Major Perioperative Complications||one month||||participants|||Number
2572437|NCT02506309|Primary|Patient Global Impression of Improvement (PGI-I) Score|"Patient Global Impression of Improvement (PGI-I) score four years after incontinence surgery. The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). It is a simple, direct, easy to use scale that is intuitively understandable to clinicians~Very much better~Much better~A little better~No change~A little worse~Much worse~Very much worse"|four years||||units on PGI-I scale||Full Range|Mean
2572438|NCT02506309|Primary|Percentage of Participants With Negative Cough Stress Test (CST)|Negative cough stress test four years after incontinence surgery.|four years||||percentage of participants|||Number
2572439|NCT02506257|Other Pre-specified|Conjunctival Examination|Change from baseline conjunctival staining at Day 14. Staining with lissamine green was used. The density of staining was graded with the Oxford Score. Score range was between 0-15. An increase in the score after treatment represent a negative outcome|Baseline and Day 14||||scores on a scale||Standard Deviation|Mean
2572440|NCT02506257|Other Pre-specified|Ocular Surface Disease Index-OSDI|Change from baseline OSDI at D 14. Score range was betwwen 0-100. An increase of OSDI values with treatment represent a negative outcome.|Baseline and Day 14||||scores on a scale||Standard Deviation|Mean
2572441|NCT02506257|Other Pre-specified|Visual Acuity|Change from baseline Visual acuity. Best corrected visual acuity was reported in decimal fraction. A decrease of visual acuity during treatment was considered a negative safety outcome.|Baseline and Day 14||||decimals||Standard Deviation|Mean
2572442|NCT02506257|Other Pre-specified|Systolic Blood Pressure|Change from baseline systolic blood pressure|Baseline and Day 14||||mmHg||Standard Deviation|Mean
2572443|NCT02506257|Secondary|Plasma Concentration of PHMB||Day14||||micrograms/ml||Standard Deviation|Mean
2572444|NCT02506257|Primary|Number of Subjects With Dose-limiting Adverse Events||up to 21 days from date of randomization||||participants|||Number
2572445|NCT02506101|Other Pre-specified|Number of Participants With Histological Change in Tissue Samples||24 weeks|No participants' data were analyzed, as no pertinent data for the outcome was obtained due to participants drop-out for personal reasons.||||||
2572446|NCT02506101|Other Pre-specified|Response Stability Index||24 weeks|No participants' data were analyzed, as no pertinent data for the outcome was obtained due to participants drop-out for personal reasons.||||||
2572447|NCT02506101|Secondary|Skindex-29 Questionnaire|Quality of life assessment|24 weeks|No participants' data were analyzed, as no pertinent data for the outcome was obtained due to participants drop-out for personal reasons.||||||
2572448|NCT02506101|Secondary|Dermatology Life Quality Index (DLQI)|Quality of life assessment|24 weeks|No participants' data were analyzed, as no pertinent data for the outcome was obtained due to participants drop-out for personal reasons.||||||
2572449|NCT02506101|Primary|Vitiligo Area Scoring Index (VASI)|VASI scores of treated versus untreated symmetrical body sites.The percentage of vitiligo involvement is calculated in terms of hand units. One hand unit is approximately equivalent to 1% of the total body surface area. The degree of pigmentation is estimated to the nearest of one of the following percentages: 100% - complete depigmentation, no pigment is present; 90% - specks of pigment present; 75% - depigmented area exceeds the pigmented area; 50% - pigmented and depigmented areas are equal; 25% - pigmented area exceeds depigmented area; and 10% - only specks of depigmentation present. The VASI for each body region is determined by the product of the area of vitiligo in hand units and the extent of depigmentation within each hand unit measured patch. Total body VASI = S All body sites [Hand Units] ´ [Residual depigmentation].|24 weeks|No participants' data were analyzed, as no pertinent data for the outcome was obtained due to participants drop-out for personal reasons.||||||
2572450|NCT02506036|Primary|Change in Social-Cognitive Functioning|Participants will be administered a test of facial emotion recognition called the Penn Emotion recognition task (Range of Scores: 0-40). Participants are shown a face and asked to identify the emotion the face displays, if any. The score reflects the number of faces where the emotion is correctly identified. A score of 35 means that the emotions of 35 out of the 40 faces was correctly identified.|Baseline, after intervention (4 - 6 weeks)||||Number Correct||Full Range|Mean
2572451|NCT02505945|Secondary|Percentage of Subjects With ≥50% Reduction in Total Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Scores|Successful Reduction at 6 months (≥50% reduction in total) Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scores from Baseline PPI On medication GERD HRQL scores.|6 months|All available follow up.|||Participants|||Count of Participants
2572494|NCT02505334|Secondary|Change in Haematology: Basophils|Change from baseline (week 0) in basophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26 and Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||10^9 cells/L||Standard Deviation|Mean
2572452|NCT02505945|Primary|Elimination of Moderate-severe Regurgitation at 6 Months|The primary endpoint was the percent of patients in both treatment arms who achieved elimination of moderate-severe regurgitation at 6 months, as reported on the foregut symptom questionnaire.|6 months|Excludes three subjects (2 LINX, 1 PPI) withdrawn following randomization and prior to either the implant procedure or start of double dose PPIs. One additional LINX subject in whom an implant was aborted due to device sizing issues was also excluded.|||Participants|||Count of Participants
2572453|NCT02505919|Primary|Score of IPSS Questionnaire Between Baseline and 6 Months|"The primary effectiveness endpoint is the IPSS change score from baseline to 6 months.~International Prostate Symptom Score (IPSS) ranges from 0 to 35. A higher score indicates a worse outcome."|Six months post-treatment|At the 6 month follow-up period, 2 of the enrolled AQUABEAM subjects and 1 of the enrolled TURP subjects did not complete the IPSS questionnaire.|||score on a scale||Standard Deviation|Mean
2572454|NCT02505919|Primary|Proportion of Subjects With Adverse Events (Clavien-Dindo Grading System Grade 2 or Higher or Any Grade 1 Event Resulting in Persistent Disability)|The primary safety endpoint is the proportion of subjects with adverse events rated as probably or definitely related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (e.g. ejaculatory disorder or erectile dysfunction) evidenced through 3 months post treatment. Note that the Clavien-Dindo classification scheme is for grading postoperative complications not events that reflect lack of effective treatment.|Three months post-treatment|At the 3 month follow-up period, 2 of the enrolled AQUABEAM subjects and 3 of the enrolled TURP subjects did not attend the office visit.|||Participants|||Count of Participants
2572455|NCT02505867|Primary|Hospital Readmissions|Number of participant hospital readmissions|Six Months||||Participants|||Count of Participants
2572456|NCT02505542|Secondary|Percentage of Participants With at Least One Adverse Event (AE) and Who Experienced a Flare During Part B of the Study|"An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.~For subjects with flare in Part B and do escape to CZP full-dose therapy, only TEAEs with an onset date after or on the start date of escape CZP full-dose therapy were included."|From time of flare to Escape Week 12|The Escape Therapy Set (ETS) consisted of all study participants from the Flared Set (FS) who received at least 1 dose of escape treatment.|||percentage of participants|||Number
2572457|NCT02505542|Secondary|Percentage of Participants With at Least One Adverse Event (AE) During Part B of the Study|"An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.~For subjects with flare in Part B and do escape to CZP full-dose therapy, only TEAEs with an onset date prior to the start date of escape CZP full-dose therapy were included."|From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication)|The Safety Set Part B (SSB) consisted of all study participants in the Randomized Set (RS) who received at least 1 dose of IMP in the Double-Blind Period of the study (Part B).|||percentage of participants|||Number
2572458|NCT02505542|Secondary|Percentage of Participants With at Least One Adverse Event (AE) During Part A of the Study|An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From Screening Period (Week -5 to Week -1) until Week 48|The Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who received at least 1 dose of investigational medicinal product (IMP).|||percentage of participants|||Number
2572459|NCT02505542|Secondary|Percentage of Participants With Positive Anti-certolizumab Pegol-antibody Levels in Plasma During the Study|"Treatment emergent ADAb status positive was defined as either baseline ADAb negative subjects having at least one ADAb confirmed positive sample post baseline or baseline ADAb positive subjects with at least one post baseline sample with >= minimum significant ratio (MSR) increase from baseline on CZP treatment. Once determined positive, the highest titer during Part A and Part B (including Escape and Safety Follow up) was used to categorize the subject.~The primary purpose of the study was to evaluate treatment options for axSpA patients after being in sustained remission. Hence, one of the objectives was to evaluate the immunogenicity of these patients. The ADAb titer of the patients that did not reach sustained remission were therefore not analysed, and the Pharmacokinetic Set A as described in the protocol was removed from the SAP."|From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication)|The Pharmacokinetic Set B (PKSB) consisted of all study participants from the Safety Set Part B (SSB) who provided at least 1 PK sample during Part B.|||percentage of participants|||Number
2572460|NCT02505542|Secondary|Certolizumab Pegol (CZP) Plasma Concentration During the Study|"CZP plasma concentration was measured in micrograms per milliliter (μg/mL). Blood sample measurements that were deemed to be below the level of quantification, were set to half the lower level of quantification (LLOQ) for analysis purposes. Summary statistics were only displayed if at least two-thirds of the values were above the LLOQ and if n was greater or equal to (>=) 4.~The primary purpose of the study was to evaluate treatment options for axSpA patients after being in sustained remission. Hence, one of the objectives was to evaluate the PK of these patients. The CZP plasma concentration of the patients that did not reach sustained remission were therefore not analysed, and the Pharmacokinetic Set A as described in the protocol was removed from the SAP."|From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication)|The Pharmacokinetic Set B (PKSB) consisted of all study participants from the Safety Set Part B (SSB) who provided at least 1 PK sample during Part B.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2572461|NCT02505542|Secondary|Change From Baseline in Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging Score for Activity (ASspIMRI-a) in the Berlin Modification Score at Escape Week 12 for Participants Who Experienced a Flare in Part B|"The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. Active inflammation was scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU.~The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening."|From time of flare to Escape Week 12|"The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.~The number of participants analyzed reflects Escape Week 12."|||scores on a scale||Standard Deviation|Mean
2572462|NCT02505542|Secondary|Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Escape Week 12 for Participants Who Experienced a Flare in Part B|"The SPARCC scoring method for lesions found on the Magnetic Resonance Imaging (MRI) is based on an abnormal increased signal on the Short-Tau-Inversion Recovery (STIR) sequence, representing bone marrow edema. Total Sacroiliac (SI) joint SPARCC score can range from 0 to 72 with higher scores indicating higher joint inflammation.~The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening."|From time of flare to Escape Week 12|"The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.~The number of participants analyzed reflects Escape Week 12."|||scores on a scale||Standard Deviation|Mean
2572463|NCT02505542|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Escape Week 12 for Participants Who Experienced a Flare in Part B|"The BASMI is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 was calculated for each item based on the measurement. The mean of the sum of the 5 scores provided the total BASMI score, ranging from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their axial spondyloarthritis (axSpA).~The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening."|From time of flare to Escape Week 12|"The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.~The number of participants analyzed reflects Escape Week 12."|||scores on a scale||Standard Deviation|Mean
2572464|NCT02505542|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Escape Week 12 for Participants Who Experienced a Flare in Part B|"The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function.~The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening."|From time of flare to Escape Week 12|"The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.~The number of participants analyzed reflects Escape Week 12."|||scores on a scale||Standard Deviation|Mean
2572465|NCT02505542|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Escape Week 12 for Participants Who Experienced a Flare in Part B|"The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.~The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening."|From time of flare to Escape Week 12|"The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.~The number of participants analyzed reflects Escape Week 12."|||scores on a scale||Standard Deviation|Mean
2572466|NCT02505542|Secondary|Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Escape Week 12 for Participants Who Experienced a Flare in Part B|"The ASDAS was calculated as the sum of the following components:~0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units).~There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score. Based on the formula even in the situation that the CRP is normal, any value below 4 is recorded as below the limit of quantification (BLQ) and a value of BLQ/2=2 was prespecified. This assumption is triggering the lowest possible value of 0.636.~The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening."|From time of flare to Escape Week 12|"The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.~The number of participants analyzed reflects Escape Week 12."|||scores on a scale||Standard Deviation|Mean
2572467|NCT02505542|Secondary|Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response Criteria Response at Escape Week 12 for Participants Who Experienced a Flare in Part B|The ASAS partial remission (PR) response was defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.|Escape Week 12|The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.|||percentage of participants|||Number
2572468|NCT02505542|Secondary|Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) 5/6 Response Criteria Response at Escape Week 12 for Participants Who Experienced a Flare in Part B|The ASAS 5/6 response was defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).|Escape Week 12|The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.|||percentage of participants|||Number
2573420|NCT02495038|Other Pre-specified|Non Invasive Blood Pressure,|"Before induction of anesthesia, non invasive blood pressure was measured for baseline.~And after injection of NMBAs, non invasive blood pressure was measured at 10 min."|Before and after induction of anesthesia, an average 10 min.||||mmHg||Standard Deviation|Mean
2572469|NCT02505542|Secondary|Percentage of Participants With Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at Escape Week 12 for Participants Who Experienced a Flare in Part B|The ASAS40 response was defined as a relative improvement of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain.|Escape Week 12|The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.|||percentage of participants|||Number
2572470|NCT02505542|Secondary|Percentage of Participants With Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at Escape Week 12 for Participants Who Experienced a Flare in Part B|The ASAS20 response was defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20% and an absolute worsening of at least 1 unit].|Escape Week 12|The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.|||percentage of participants|||Number
2572471|NCT02505542|Secondary|Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B|"The ASDAS was calculated as the sum of the following components:~0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units).~ASDAS improvement was measured by binary response variables:~ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline~ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline"|Escape Week 12|The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.|||percentage of participants|||Number
2572472|NCT02505542|Secondary|Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B|"The ASDAS was calculated as the sum of the following components:~0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units).~Disease activity was measured by categorical response variables:~ASDAS-Inactive Disease (ASDAS-ID): ASDAS < 1.3~ASDAS-Moderate Disease (ASDAS-MD): ASDAS ≥ 1.3, < 2.1~ASDAS-High Disease activity (ASDAS-HD): ASDAS ≥ 2.1, ≤ 3.5~ASDAS-very High Disease activity (ASDAS-vHD): ASDAS > 3.5"|Escape Week 12|The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.|||percentage of participants|||Number
2572473|NCT02505542|Secondary|Change From Baseline in Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging Score for Disease Activity (ASspIMRI-a) in the Berlin Modification Score at Week 96 in Part B|"The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. Active inflammation was scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU.~The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening."|From Week 48 to Week 96|"The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.~The number of participants analyzed reflects Week 96."|||scores on a scale||Standard Deviation|Mean
2572474|NCT02505542|Secondary|Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 96 in Part B|"The SPARCC scoring method for lesions found on the Magnetic Resonance Imaging (MRI) is based on an abnormal increased signal on the Short-Tau-Inversion Recovery (STIR) sequence, representing bone marrow edema. Total Sacroiliac (SI) joint SPARCC score can range from 0 to 72 with higher scores indicating higher joint inflammation.~The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening."|From Week 48 to Week 96|"The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.~The number of participants analyzed reflects Week 96."|||scores on a scale||Standard Deviation|Mean
2572475|NCT02505542|Secondary|Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response Criteria Response at Week 96 in Part B|"The BASDAI50 response was defined as an improvement of at least 50 % in the BASDAI score relative to Baseline.~Missing data were handled using non-response imputation (NRI) methods."|Week 96|The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.|||percentage of participants|||Number
2572476|NCT02505542|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 96 in Part B|"The BASMI is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 was calculated for each item based on the measurement. The mean of the sum of the 5 scores provided the total BASMI score, ranging from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their axial spondyloarthritis (axSpA).~The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening."|From Week 48 to Week 96|The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.|||scores on a scale||Standard Error|Least Squares Mean
2574801|NCT02476448|Other Pre-specified|Number of Participants With Urinary Tract Infections|Medical records will be followed prospectively for 6 weeks to assess for incidence of urinary tract infections within different groups.|6 weeks||||Participants|||Count of Participants
2572477|NCT02505542|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 96 in Part B|"The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function.~The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening."|From Week 48 to Week 96|The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.|||scores on a scale||Standard Error|Least Squares Mean
2572478|NCT02505542|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 96 in Part B|"The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity.~The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening."|From Week 48 to Week 96|The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.|||scores on a scale||Standard Error|Least Squares Mean
2572479|NCT02505542|Secondary|Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 96 in Part B|"The ASDAS was calculated as the sum of the following components:~0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units).~There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score. Based on the formula even in the situation that the CRP is normal, any value below 4 is recorded as below the limit of quantification (BLQ) and a value of BLQ/2=2 was prespecified. This assumption is triggering the lowest possible value of 0.636.~The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening."|From Week 48 to Week 96|The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.|||scores on a scale||Standard Error|Least Squares Mean
2572480|NCT02505542|Secondary|Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response Criteria Response at Week 96 in Part B|"The ASAS partial remission (PR) response was defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.~Missing data were handled using non-response imputation (NRI) methods."|Week 96|The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.|||percentage of participants|||Number
2572481|NCT02505542|Secondary|Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) 5/6 Response Criteria Response at Week 96 in Part B|"The ASAS 5/6 response was defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP).~Missing data were handled using non-response imputation (NRI) methods."|Week 96|The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.|||percentage of participants|||Number
2572482|NCT02505542|Secondary|Percentage of Participants With Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at Week 96 in Part B|"The ASAS40 response was defined as a relative improvement of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain.~Missing data were handled using non-response imputation (NRI) methods."|Week 96|The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.|||percentage of participants|||Number
2572483|NCT02505542|Secondary|Percentage of Participants With Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at Week 96 in Part B|"The ASAS20 response was defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain [deterioration was defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit].~Missing data were handled using non-response imputation (NRI) methods."|Week 96|The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.|||percentage of participants|||Number
2572484|NCT02505542|Secondary|Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 96 in Part B|"The ASDAS was calculated as the sum of the following components:~0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units).~ASDAS improvement was measured by binary response variables:~ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline~ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline~Missing data were handled using non-response imputation (NRI) methods."|Week 96|The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.|||percentage of participants|||Number
2572495|NCT02505334|Secondary|Change in Haematology: Neutrophils|Change from baseline (week 0) in neutrophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26 and Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||10^9 cells/L||Standard Deviation|Mean
2572485|NCT02505542|Secondary|Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 96 in Part B|"The ASDAS was calculated as the sum of the following components:~0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units).~Disease activity was measured by categorical response variables:~ASDAS-Inactive Disease (ASDAS-ID): ASDAS < 1.3~ASDAS-Moderate Disease (ASDAS-MD): ASDAS ≥ 1.3, < 2.1~ASDAS-High Disease activity (ASDAS-HD): ASDAS ≥ 2.1, ≤ 3.5~ASDAS-very High Disease activity (ASDAS-vHD): ASDAS > 3.5"|Week 96|The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.|||percentage of participants|||Number
2572486|NCT02505542|Secondary|Time to Flare in Part B|"For those who met the criteria for flare (see primary efficacy variable), the time to flare was the length in days from randomization in Part B until the visit at which the criteria for flare were met. Participants who discontinued the study without meeting the criteria for flare were counted as experiencing a flare at the time of their last study visit.~The time to flare was analyzed using Kaplan-Meier methods. If Kaplan-Meier Estimate was NA for all estimates then more than 75 % failed to meet the flare condition.~Missing data were handled using non-response imputation (NRI) methods."|From Week 48 to Week 96|The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.|||days||Inter-Quartile Range|Median
2572487|NCT02505542|Secondary|Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 48 in Part A|"The ASDAS was calculated as the sum of the following components:~0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units).~ASDAS improvement was measured by binary response variables:~ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline~ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline~Missing data were handled using non-response imputation (NRI) methods."|Week 48|The Open-Label Set (OLS) consisted of all study participants who received at least 1 dose of IMP in the Open-Label Period of the study (Part A).|||percentage of participants|||Number
2572488|NCT02505542|Secondary|Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 48 in Part A|"The ASDAS was calculated as the sum of the following components:~0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units).~Disease activity was measured by categorical response variables:~ASDAS-Inactive Disease (ASDAS-ID): ASDAS < 1.3~ASDAS-Moderate Disease (ASDAS-MD): ASDAS ≥ 1.3, < 2.1~ASDAS-High Disease activity (ASDAS-HD): ASDAS ≥ 2.1, ≤ 3.5~ASDAS-very High Disease activity (ASDAS-vHD): ASDAS > 3.5~Missing data were handled using last observation carried forward (LOCF) methods."|Week 48|The Open-Label Set (OLS) consisted of all study participants who received at least 1 dose of IMP in the Open-Label Period of the study (Part A).|||percentage of participants|||Number
2572489|NCT02505542|Secondary|Percentage of Participants Achieving Sustained Remission at Week 48 in Part A|"Sustained remission was achieved when a participant had an ASDAS less than (<) 1.3 at Week 32 or Week 36 (if ASDAS < 1.3 at Week 32, it must have been < 2.1 at Week 36; if ASDAS < 2.1 at Week 32, it must have been < 1.3 at Week 36) and an ASDAS < 1.3 at Week 48.~Missing data were handled using non-response imputation (NRI) methods."|Week 48|The Open-Label Set (OLS) consisted of all study participants who received at least 1 dose of investigational medicinal product (IMP) in the Open-Label Period of the study (Part A).|||percentage of participants||95% Confidence Interval|Number
2572490|NCT02505542|Primary|Percentage of Participants in Part B Who Did Not Experienced a Flare|"A participant was considered to have experienced a flare if the participant had an Ankylosing spondylitis disease activity score (ASDAS) greater or equal to (≥) 2.1 at 2 consecutive visits or an ASDAS greater than (>) 3.5 at any visit during Part B up until Week 96.~A participant qualified for Part B only if he achieved sustained remission after 48 weeks of Open-Label certolizumab pegol (CZP) treatment. Sustained remission was achieved when a participant had an ASDAS less than (<) 1.3 at Week 32 or Week 36 (if ASDAS < 1.3 at Week 32, it must have been < 2.1 at Week 36; if ASDAS < 2.1 at Week 32, it must have been < 1.3 at Week 36) and an ASDAS < 1.3 at Week 48.~Missing data were handled using non-response imputation (NRI) methods."|From Week 48 to Week 96|The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.|||percentage of participants||95% Confidence Interval|Number
2572491|NCT02505334|Secondary|Change in Calcitonin|Reported results are number of subjects with low, normal or high calcitonin values at week 0, week 26 and week 52. Number of subjects analyzed = number of subjects contributed to the analysis for individual time point. Calcitonin values were categorised as low, normal or high.|Week 0 and Week 26 and Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||Participants|||Count of Participants
2572492|NCT02505334|Secondary|Change in Haematology: Lymphocytes|Change from baseline (week 0) in lymphocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26 and Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||10^9 cells/L||Standard Deviation|Mean
2572493|NCT02505334|Secondary|Change in Haematology: Monocytes|Change from baseline (week 0) in monocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26 and Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||10^9 cells/L||Standard Deviation|Mean
2572496|NCT02505334|Secondary|Change in Haematology: Eosinophils|Change from baseline (week 0) in eosinophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26 and Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||10^9 cells/L||Standard Deviation|Mean
2572497|NCT02505334|Secondary|Change in Haematology: Leukocytes|Change from baseline (week 0) in leukocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26 and Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||10^9 cells/L||Standard Deviation|Mean
2572498|NCT02505334|Secondary|Change in Haematology: Erythrocytes|Change from baseline (week 0) in erythrocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26 and Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||10^12 cells/L||Standard Deviation|Mean
2572499|NCT02505334|Secondary|Change in Haematology: Thrombocytes|Change from baseline (week 0) in thrombocytes (platelets) was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26 and Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||10^9 cells/L||Standard Deviation|Mean
2572500|NCT02505334|Secondary|Change in Haematology: Haematocrit|Change from baseline (week 0) in haematocrit was evaluated after 26 weeks and 52 weeks of treatment, respectively. Haematocrit is the ratio of the volume of red blood cells to the total volume of blood.|Week 0, Week 26, Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||% of red blood cell||Standard Deviation|Mean
2572501|NCT02505334|Secondary|Change in Haematology: Haemoglobin|Change from baseline (week 0) in haemoglobin was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||g/dL||Standard Deviation|Mean
2572502|NCT02505334|Secondary|Change in Biochemistry: Lipase|Change from baseline (week 0) in lipase was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||U/L||Standard Deviation|Mean
2572503|NCT02505334|Secondary|Change in Biochemistry: Amylase|Change from baseline (week 0) in amylase was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||U/L||Standard Deviation|Mean
2572504|NCT02505334|Secondary|Change in Biochemistry: Albumin Corrected Calcium|Change from baseline (week 0) in albumin corrected calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||mg/dL||Standard Deviation|Mean
2572505|NCT02505334|Secondary|Change in Biochemistry: Calcium|Change from baseline (week 0) in calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||mg/dL||Standard Deviation|Mean
2572506|NCT02505334|Secondary|Change in Biochemistry: Creatine Kinase|Change from baseline (week 0) in creatine kinase was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||U/L||Standard Deviation|Mean
2572507|NCT02505334|Secondary|Change in Biochemistry: Urea|Change from baseline (week 0) in urea was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||mg/dL||Standard Deviation|Mean
2572508|NCT02505334|Secondary|Change in Biochemistry: Total Bilirubin|Change from baseline (week 0) in total bilirubin was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||mg/dL||Standard Deviation|Mean
2572611|NCT02504294|Primary|Percentage of Time When Participants Had Hemoglobin Levels Between 9 to 11 Gram Per Deciliter (g/dL)||Week 17 up to Week 24|"FAS included all participants who received at least 1 dose of study medication after randomization into the study. Here, Number of participants analyzed (N) signifies those number of participants who were evaluable for this outcome measure."|||Percentage of Weeks||95% Confidence Interval|Number
2572509|NCT02505334|Secondary|Change in Biochemistry: Albumin|Change from baseline (week 0) in albumin was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||g/L||Standard Deviation|Mean
2572510|NCT02505334|Secondary|Change in Biochemistry: Potassium|Change from baseline (week 0) in potassium was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||mmol/L||Standard Deviation|Mean
2572511|NCT02505334|Secondary|Change in Biochemistry: Sodium|Change from baseline (week 0) in sodium was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||mmol/L||Standard Deviation|Mean
2572512|NCT02505334|Secondary|Change in Biochemistry: Alkaline Phosphatase|Change from baseline (week 0) in alkaline phosphatase was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||U/L||Standard Deviation|Mean
2572513|NCT02505334|Secondary|Change in Biochemistry: Aspartate Aminotransferase|Change from baseline (week 0) in aspartate aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||U/L||Standard Deviation|Mean
2572514|NCT02505334|Secondary|Change in Biochemistry: Alanine Aminotransferase|Change from baseline (week 0) in alanine aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||U/L||Standard Deviation|Mean
2572515|NCT02505334|Secondary|Change in Biochemistry: eGFR|Change from baseline (week 0) in estimated glomerular filtration rate (eGFR) was evaluated after 26 weeks and 52 weeks of treatment, respectively. eGFR was evaluated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, mL/min/1.73m^2.|Week 0, Week 26, Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||mL/min/1.73m^2||Standard Deviation|Mean
2572516|NCT02505334|Secondary|Change in Biochemistry: Creatinine|Change from baseline (week 0) in creatinine was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||mg/dL||Standard Deviation|Mean
2572517|NCT02505334|Secondary|Change in Electrocardiogram (ECG)|Reported results are ECG outcomes at week 0, week 26 and week 52. ECG outcomes were evaluated as: 1) normal, 2) abnormal, NCS or 3) abnormal, CS.|Week 0 and Week 26 and Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||Participants|||Count of Participants
2572518|NCT02505334|Secondary|Change in Eye Examination|Reported results are eye examination (ophthalmoscopy) outcomes at week 0, week 26 and week 52. Ophthalmoscopy outcomes for both left and right eye were evaluated as: 1) normal, 2) abnormal, NCS or 3) abnormal, CS.|Week 0 and Week 26 and Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||Participants|||Count of Participants
2572519|NCT02505334|Secondary|Change in Physical Examination|"Reported results are physical examination outcomes at week (wk) 0, wk 26 and wk 52. Physical examination consisted of the following listed examinations and the outcome of each examination was evaluated as: 1) normal, 2) abnormal, not clinically significant (NCS) or 3) abnormal, clinically significant (CS).~Cardiovascular system~Central and peripheral nervous system (PNS)~Gastrointestinal (GI) system including mouth~General appearance~Head, ears, eyes, nose, throat, neck~Lymph node palpation~Musculoskeletal system~Respiratory system~Skin~Thyroid gland"|Week 0 and Week 26 and Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||Participants|||Count of Participants
2572520|NCT02505334|Secondary|Change in Pulse|Change from baseline (week 0) in pulse was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||Beats/minute||Standard Deviation|Mean
2572812|NCT02501161|Secondary|Change in Haematological Parameter- Monocytes|Change in monocytes from baseline (week 0) to week 26 and week 104 is presented.|Week 0, week 26, week 104|SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.|||Percentage of monocytes||Standard Deviation|Mean
2572521|NCT02505334|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition|"American Diabetes Association (ADA) classification of hypoglycaemia:~Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.~Documented symptomatic: PG level ≤3.9 mmol/L with symptoms.~Asymptomatic: PG level ≤3.9 mmol/L without symptoms.~Probable symptomatic: No measurement with symptoms.~Pseudo: PG level >3.9 mmol/L with symptoms. Treatment emergent hypoglycaemic episode: episode with onset date on or after randomisation (from week 0) and no later than 7 days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'Week 0-26 + 7 days and Week 0-52 + 7 days'."|Weeks 0-26 and Weeks 0-52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period).|||Episodes|||Number
2572522|NCT02505334|Secondary|Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes|Treatment emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes were evaluated during the26-week and 52-week treatment period, respectively. Nocturnal hypoglycaemic episodes: Those occurring between 00:01 and 05:59 hours, both inclusive. Severe or BG confirmed symptomatic hypoglycaemia: episode that was severe according to the ADA classification or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Treatment emergent: episode with onset date on or after randomisation (from week 0) and no later than 7 days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'Week 0-26 + 7 days and Week 0-52 + 7 days'.|Weeks 0-26 and Weeks 0-52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period).|||Episodes|||Number
2572523|NCT02505334|Secondary|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes|Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were evaluated during the 26-week and 52-week treatment period, respectively. Severe or BG confirmed symptomatic hypoglycaemia (hypo):An episode that was severe according to the ADA classification or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypo. ADA definition of severe hypo:episode requiring assistance of another person to actively administer carbohydrate/glucagon, or take other corrective actions. PG levels may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG level. Treatment emergent: episode with onset date on or after randomisation (from week (wk) 0) and no later than 7 days after the last day on liraglutide (maximum till wk 26 and wk 52, respectively + 7 days). Hence, the following shown 'Time Frame' should be read as 'wk 0-26+7 days and wk 0-52+7 days'.|Weeks 0-26 and Weeks 0-52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for weeks 0-52, as the subjects in this treatment arm received treatment for 26 weeks (main period).|||Episodes|||Number
2572524|NCT02505334|Secondary|Number of Treatment Emergent Adverse Events|Treatment emergent adverse events (TEAEs) were evaluated during the 26-week and 52-week treatment period, respectively. TEAE for weeks 0-26: Event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 + 7 days). TEAE for weeks 0-52: Event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 52 + 7 days). Hence, the following shown 'Time Frame' should be read as 'Weeks 0-26 + 7 days and Weeks 0-52 + 7 days'.|Weeks 0-26 and Weeks 0-52|Safety analysis set, which included all subjects receiving at least one dose of liraglutide. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for weeks 0-52, as the subjects in this treatment arm received treatment for 26 weeks (main period).|||Events|||Number
2572525|NCT02505334|Secondary|Free Fatty Acids|Free fatty acids were evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 26 and Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||mg/dL||Geometric Coefficient of Variation|Geometric Mean
2572526|NCT02505334|Secondary|Triglycerides|Triglycerides were evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 26 and Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||mg/dL||Geometric Coefficient of Variation|Geometric Mean
2572527|NCT02505334|Secondary|Very Low Density Lipoprotein (VLDL) Cholesterol|VLDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 26 and Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||mg/dL||Geometric Coefficient of Variation|Geometric Mean
2572528|NCT02505334|Secondary|High Density Lipoprotein (HDL) Cholesterol|HDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 26 and Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||mg/dL||Geometric Coefficient of Variation|Geometric Mean
2572529|NCT02505334|Secondary|Low Density Lipoprotein (LDL) Cholesterol|LDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 26 and Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||mg/dL||Geometric Coefficient of Variation|Geometric Mean
2572530|NCT02505334|Secondary|Total Cholesterol|Total cholesterol was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 26 and Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||mg/dL||Geometric Coefficient of Variation|Geometric Mean
2572531|NCT02505334|Secondary|Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)|HOMA-IR was evaluated after 26 weeks and 52 weeks of treatment, respectively. HOMA-IR is an index of insulin resistance and was calculated as: HOMA-IR= fasting insulin (μU/mL) x FPG (mmol/L)/22.5.|Week 26 and Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||HOMA-IR score||Geometric Coefficient of Variation|Geometric Mean
2572532|NCT02505334|Secondary|Homeostasis Model Assessment of Beta-cell Function (HOMA-B)|HOMA-B was evaluated after 26 weeks and 52 weeks of treatment, respectively. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B=[(20 x fasting insulin in µU/mL)/(FPG in mmol/L-3.5)].|Week 26 and Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||Percentage (%) of beta-cell function||Geometric Coefficient of Variation|Geometric Mean
2572533|NCT02505334|Secondary|Proinsulin/Insulin|Proinsulin/insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 26 and Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||Percentage (%) of proinsulin/insulin||Geometric Coefficient of Variation|Geometric Mean
2572534|NCT02505334|Secondary|Proinsulin|Proinsulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 26 and Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2572535|NCT02505334|Secondary|Fasting Glucagon|Fasting glucagon was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 26 and Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2572536|NCT02505334|Secondary|Fasting Insulin|Fasting insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 26 and Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2572537|NCT02505334|Secondary|Fasting C-peptide|Fasting C-peptide was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 26 and Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2572538|NCT02505334|Secondary|Change in Blood Pressure (Systolic and Diastolic)|Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||mmHg||Standard Deviation|Mean
2572539|NCT02505334|Secondary|Change in Body Mass Index (BMI)|Change from baseline (week 0) in BMI was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||kg/m^2||Standard Deviation|Mean
2572540|NCT02505334|Secondary|Change in Body Weight|Change from baseline (week 0) in body weight was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||Kilogram (kg)||Standard Deviation|Mean
2572541|NCT02505334|Secondary|Change in Waist Circumference|Change from baseline (week 0) in waist circumference was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||Centimeter (cm)||Standard Deviation|Mean
2572542|NCT02505334|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline (week 0) in FPG was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||mg/dL||Standard Deviation|Mean
2572543|NCT02505334|Secondary|Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)|Change from baseline (week 0) in mean of postprandial increments (from before meal to 90 minutes after for breakfast, lunch and dinner) of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|FAS, which included all randomised subjects. Number analyzed = number of subjects contributed to the analysis. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||mg/dL||Standard Deviation|Mean
2572544|NCT02505334|Secondary|Change in SMBG 7-point Profile: Mean of 7-point Profile|Change from baseline (week 0) in mean of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively.|Week 0, Week 26, Week 52|FAS, which included all randomised subjects. Number analyzed = number of subjects contributed to the analysis. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||mg/dL||Standard Deviation|Mean
2572545|NCT02505334|Secondary|Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)|"Reported results are 7-point SMBG values at week 0, week 26 and week 52. The 7-point profile blood glucose levels were measured at the following time points always starting with the first:~Before breakfast.~90 minutes after start of breakfast.~Before lunch.~90 minutes after start of lunch.~Before dinner.~90 minutes after start of dinner.~At bedtime."|Week 0 and Week 26 and Week 52|FAS, which included all randomised subjects. Number analyzed = number of subjects contributed to the analysis. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method|||mg/dL||Standard Deviation|Mean
2572546|NCT02505334|Secondary|Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes|Reported results are subjects with HbA1c <7.0% after 26 weeks and 52 weeks of treatment, respectively without treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. Severe or BG confirmed symptomatic hypoglycaemia: severe as per ADA classification or BG confirmed by plasma glucose (PG) value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA: episode requiring assistance of another person to actively administer carbohydrate/glucagon, or take other corrective actions. PG levels may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG level. Treatment emergent: episode with onset date on or after randomisation (from week (wk)0) and no later than 7 days after the last day on liraglutide (maximum till wk26+7days and wk52+7days). Hence, the following shown 'Time Frame' should be read as 'Wk26+7days and Wk52+7days'|Week 26 and Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing HbA1c values were imputed using the LOCF method.|||Participants|||Count of Participants
2572547|NCT02505334|Secondary|Responder for HbA1c Below 7.0% Without Weight Gain|Reported results are number of subjects who achieved HbA1c target below 7.0% without weight gain after 26 weeks and 52 weeks of treatment, respectively.|Week 26 and Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing HbA1c and body weight values were imputed using the LOCF method.|||Participants|||Count of Participants
2572548|NCT02505334|Secondary|Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)|Reported results are number of subjects who achieved HbA1c target below or equal to 6.5% after 26 weeks and 52 weeks of treatment, respectively.|Week 26 and Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing HbA1c values were imputed using the LOCF method.|||Participants|||Count of Participants
2572549|NCT02505334|Secondary|Responder for HbA1c Below 7.0% (53 mmol/Mol)|Reported results are number of subjects who achieved HbA1c target below 7.0% after 26 weeks and 52 weeks of treatment, respectively.|Week 26 and Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for week 52, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing HbA1c values were imputed using the LOCF method.|||Participants|||Count of Participants
2572550|NCT02505334|Secondary|Change in HbA1c (Week 52)|Change from baseline (week 0) in HbA1c was evaluated after 52 weeks of treatment.|Week 0, Week 52|FAS, which included all randomised subjects. ‘Liraglutide 0.9 mg treatment arm’ is not applicable for this outcome measure, as the subjects in this treatment arm received treatment for 26 weeks (main period). Missing values were imputed using the LOCF method.|||Percentage (%) of HbA1c||Standard Deviation|Mean
2572551|NCT02505334|Primary|Change in Glycosylated Haemoglobin (HbA1c) (Week 26)|Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of treatment. The change from baseline in the response after 26 weeks of treatment is analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline response as a covariate.|Week 0, Week 26|FAS, which included all randomised subjects. Missing values were imputed using the last observation carried forward (LOCF) method.|||Percentage (%) of HbA1c||Standard Error|Least Squares Mean
2572552|NCT02504931|Secondary|PTSD (Post Traumatic Stress Disorder) Symptom Score From PCL (Patient Monitoring Checklist)|"The PCL is a self-report measure that can be completed by patients in a waiting room prior to a session or by participants as part of a research study.~The survey has 20 questions scored as:~0=Not at all~A little bit~Moderately~Quite a bit~Extremely~Interpretation of the PCL should be made by a clinician. The total symptom severity score is obtained by summing the scores for each of the 20 items to give a total of 1-80 points. The lower the score, the less severe the symptoms of PTSD, the higher the score, the more severe the symptoms."|12 weeks of treatment||||Units on a scale||Standard Deviation|Mean
2572553|NCT02504931|Primary|Percent Heavy Drinking Days|Number of heavy drinking days in a 12 week period is reported by subjects and the percentage is calculated.|12 weeks||||percentage of days||Standard Deviation|Mean
2572554|NCT02504892|Secondary|Count of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence.|Date treatment consent signed to date off study, approximately 8 months and 28 days.||||Participants|||Count of Participants
2572555|NCT02504892|Secondary|Overall Survival (OS)|Overall Survival is defined as the time between the first day of treatment to the day of death.|From the first day of treatment to the day of death, up to 1 year|Because all the 3 patients were alive as of date of off study, their median time to death is unknown.|||Months||95% Confidence Interval|Median
2572571|NCT02504671|Secondary|Number of Participants With Serious Infections|An AE is any untoward medical occurrence in a participant or clinical investigation participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious infections were categorized as AE of special interest. The number of participants with overall serious infections have been presented.|Up to 62 weeks|ITT Population|||Participants|||Count of Participants
2574802|NCT02476448|Secondary|Surgeon Satisfaction|"A 4 point likert scale will be completed during the procedure to assess satisfaction as follows:~very satisfied~satisfied~somewhat satisfied~unacceptable"|5 mins||||Participants|||Count of Participants
2572556|NCT02504892|Secondary|Progression-free Survival (PFS)|Progression-free survival is defined as the time interval from start of treatment to documented evidence of disease progression. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5mm. Note: the appearance of one or more new lesions is also progression. Progressive disease was assessed by the Response Evaluation in Solid Tumors (RECIST) criteria v1.1.|median follow-up time: 9 months|Because all the 3 patients were alive without progression as of date of off study their median time to progression cannot be determined.|||Months||95% Confidence Interval|Median
2572557|NCT02504892|Primary|Overall Response Rate With Everolimus Treatment.|Overall best response is defined as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed by the Response Evaluation in Solid Tumors (RECIST) criteria v1.1. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5mm. Note: the appearance of one or more new lesions is also progression. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the diameters of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.|End of treatment: every 12 weeks up to 1 year||||Participants|||Count of Participants
2572558|NCT02504827|Primary|Peak Sputum Concentration||8 hours||||mg/L||Full Range|Mean
2572559|NCT02504827|Primary|Peak Plasma Concentration (Cmax)||8 hours||||mg/L||Full Range|Mean
2572560|NCT02504775|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Tmax of paracetamol was obtained graphically from the plasma concentration over time profile. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 h after each period.|2 days|One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis|||Hours (h)||Standard Deviation|Mean
2572561|NCT02504775|Primary|Maximum Plasma Concentration (Cmax)|Cmax of paracetamol was obtained graphically from the plasma concentration over time profile. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 h after each period.|2 days|One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis|||micogram per mililitre (μg/mL)||Standard Deviation|Mean
2572562|NCT02504775|Primary|Area Under the Curve From Time Zero Extrapolated to Infinity [AUC(0-inf)]|AUC(0-inf) of paracetamol was calculated using the trapezoidal rule. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 h after each period.|2 days|One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis|||h*μg/mL||Standard Deviation|Mean
2572563|NCT02504775|Primary|Area Under the Curve From Time Zero to Last Sampling Time [AUC(0-t)]|AUC(0-t) of paracetamol was calculated using the trapezoidal rule. Blood samples were taken before the administration of the reference/test product (pre-dose) and at 0.250, 0.333, 0.500, 0.667, 0.833, 1.000, 1.250, 1.500, 1.750, 2.000, 4.000, 6.000, 8.000, 12.000 and 16.000 hours (h) after each period.|2 days|One participant had a positive pre-dose sample in the second period of the study, equivalent to 7.74% of their Cmax, therefore, his data was not taken into account in the bioequivalence analysis|||hours*microgram/millilitre (h*μg/mL)||Standard Deviation|Mean
2572564|NCT02504723|Secondary|All Adverse Effects|All adverse effects during the study period|Within 6 years||||Participants|||Count of Participants
2572565|NCT02504723|Secondary|All Cause Mortality or Liver Transplantation|All cause mortality or liver transplantation during the study period|Within 6 years||||Participants|||Count of Participants
2572566|NCT02504723|Secondary|All Upper Gastrointestinal Bleeding|All upper gastrointestinal bleeding during the follow-up period|Within 6 years||||Participants|||Count of Participants
2572567|NCT02504723|Primary|Rebleeding From Gastric Varices|Rebleeding from gastric varices during the follow-up period|Within 6 years||||Participants|||Count of Participants
2572568|NCT02504671|Secondary|Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry|Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen, that is called as blood oxygen saturation. Baseline was defined as the last available assessment prior to the start of study treatment. The number of participants with blood oxygen level < 80%, 80% to <90% and >=90% have been reported.|Up to 62 weeks|ITT Population. Only those participants with data available at specified time point were analyzed (represented by n=x in category titles).|||Participants|||Count of Participants
2572569|NCT02504671|Secondary|Number of Participants With Pulmonary Events|Pulmonary assessments were performed to determine the number of participants with pulmonary events including persistent cough, persistent dyspnea, and persistent Diffusing capacity of the lung for carbon monoxide (DLCO). Persistent is defined as any event with duration >=15 days. Baseline was defined as the last available assessment prior to the start of study treatment. The number of participants experiencing pulmonary events have been reported.|Up to 62 weeks|ITT Population|||Participants|||Count of Participants
2572570|NCT02504671|Secondary|Number of Participants With Opportunistic Infections|An AE is any untoward medical occurrence in a participant or clinical investigation participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Opportunistic infections were categorized as AE of special interest. The number of participants with overall opportunistic infections have been presented.|Up to 62 weeks|ITT Population|||Participants|||Count of Participants
2572572|NCT02504671|Secondary|Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)|An AE is any untoward medical occurrence in a participant or clinical investigation participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or any other situations as per Medical or Scientific judgment. Overall AEs and SAEs for the entire study duration until follow-up have been presented.|Up to 62 weeks|ITT Population|||Participants|||Count of Participants
2572573|NCT02504671|Secondary|Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points|BFI is a self-reported instrument consisting of nine questions which correlate well with quality-of-life measures. For this study, Question 3 only was used which asked about fatigue severity at its worst in the last 24 hours. A discrete 11 unit numeric reporting scale was used where 0 =No fatigue, and 10=As bad as you can imagine. Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.|Baseline and Weeks 4, 12, 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Scores on a scale||Standard Error|Least Squares Mean
2572574|NCT02504671|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points|The FACIT-fatigue questionnaire is a participant reported measure developed to assess fatigue consisting of 13 statements regarding feeling fatigue using a numeric rating scale ranging from 0 to 4. For only two of the items (i.e. Answer 5 [An5] and An7) a higher value represents a lower fatigue; 11 of the item scores (i.e. HI7, HI12, An1, An2, An3, An4, An8, An12, An14, An15, An16) have to be reversed by subtracting the captured value from 4 (0 is turned to a 4; 1 into 3; 3 into 1; 4 into 0). After performing the reversals the sum of the non-missing individual items were multiplied by 13 and divided by the number of the non-missing individual items. The final score ranges from 0 to 52 with higher values representing a lower fatigue (i.e. a better quality of life). Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.|Baseline and Weeks 4, 12, 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Scores on a scale||Standard Error|Least Squares Mean
2572575|NCT02504671|Secondary|Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points|SF-36 is a generic health survey containing 36 questions covering 8 domains of health. SF-36 yields an 8-scale profile of functional health and well-being scores as well as PCS and MCS health summary scores. The version 2, 1-week recall questionnaire was used. Recoding, calculations and standardization were done as per the User's manual of SF-36. Domain scores were only calculated if less than half of the item scores were missing. All raw domain scores were transformed on a 0-100 scale (transformed domain scores) and then standardized into norm-based scores using Z-score. Following the transformation of the 8 domain scores into z-scores, the MCS and PCS were aggregated (AGG) using weights as PCS/MCS = 50 + (AGG_PHYS *10/AGG_MENT *10). High score (worse outcome) and low score (better outcome). Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.|Baseline and Weeks 4, 12, 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Scores on a scale||Standard Error|Least Squares Mean
2572576|NCT02504671|Secondary|Change From Baseline in Pain Score at All Assessment Time Points|Participants assessed the severity of their current arthritis pain using a 100 unit visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain. Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.|Baseline and Weeks 1, 2, 4, 6, 8, 12, 16, 20 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Scores on a scale||Standard Error|Least Squares Mean
2572577|NCT02504671|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points|HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas;dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each functional area contains at least two questions. For each question, there is a four level response set that is scored from 0 (without any difficulty) to 3 (unable to do). If aids or devices or physical assistance are used for a specific functional area and the maximum response of this functional area is 0 or 1 the according value is increased to a score of 2. HAQ-DI is only calculated if there are at least 6 functional area scores available. The average of these non-missing functional area scores defines the continuous HAQ-DI score ranging from 0 to 3. Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.|Baseline and Weeks 1, 2, 4, 6, 8, 12, 16, 20 and 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Scores on a scale||Standard Error|Least Squares Mean
2572578|NCT02504671|Secondary|Change From Baseline in CDAI at All Assessment Time Points|CDAI combines information relating to the number of swollen and tender joints, in addition to a measure of general health from both the participants and the physician. CDAI utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: CDAI =TJC28 + SJC28 + GH + GP Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity and GP=physician assessment of disease activity using a 10 cm visual analogue scale with 0 = best, 100 = worst). It ranges between 0 and 76. High score indicates worse outcome, low score indicates better outcome. Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.|Baseline and Weeks 1, 2, 4, 6, 8, 12, 16, 20 and 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Scores on a scale||Standard Error|Least Squares Mean
2572579|NCT02504671|Secondary|Change From Baseline in SDAI at All Assessment Time Points|SDAI combines information relating to the number of swollen and tender joints, in addition to a measure of general health from both the participants and the physician and acute phase reactants. The SDAI utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal-phalangeal I-V, proximal interphalangeal I-V and knees. It is calculated using the following formula: SDAI = TJC28 + SJC28 + GH + GP + CRP Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment, GP= physician assessment of disease activity using a 10 centimetre [cm] visual analogue scale [VAS] with 0 = best, 10 = worst), and CRP= C reactive Protein (in mg/L). It ranges between 0.1 and 86. High score indicates worse outcome, low score indicates better outcome. Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.|Baseline and Weeks 1, 2, 4, 6, 8, 12, 16, 20 and 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Scores on a scale||Standard Error|Least Squares Mean
2572580|NCT02504671|Secondary|Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission|CDAI combines information relating to the number of swollen and tender joints, in addition to a measure of general health from both the participants and the physician. CDAI utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: CDAI =TJC28 + SJC28 + GH + GP Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity and GP=physician assessment of disease activity using a 10 cm visual analogue scale with 0 = best, 100 = worst). It ranges between 0 and 76. High score indicates worse outcome, low score indicates better outcome. Remission was achieved for a non-missing CDAI value <=2.8.|Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)|ITT Population|||Percentage of participants|||Number
2572581|NCT02504671|Secondary|Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points|Boolean-based remission was achieved if all of the following requirements were met at the same time: TJC68 <= 1,SJC66 <= 1,CRP <= 1mg/dL, PtGA <= 10. If one of the components was missing at an individual assessment point, Boolean-based remission for that assessment was set to missing.|Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)|ITT Population|||Percentage of participants|||Number
2572582|NCT02504671|Secondary|Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points|Index-based remission was achieved if the following requirement was met: SDAI <= 3.3. If the SDAI value was missing at an individual assessment point, Index-based remission for that assessment was set to missing.|Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)|ITT Population|||Percentage of participants|||Number
2572583|NCT02504671|Secondary|Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points|The ACR definition for calculating improvement in rheumatoid arthritis is calculated as a 20% improvement (ACR20) in both tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR-core set measures: participant and physician global assessments, participant's assessment of arthritis pain, disability, and an acute-phase reactant (i.e. CRP value). Similarly, ACR50 and ACR70 were calculated with the respective percent improvement. The specific components of the ACR assessments are as follows: Tender/Painful Joint count 68 (TJC68), Swollen Joint Count 66 (SJC66), Participant's Assessment of Arthritis Pain, Participant's Global Assessment of Arthritis Disease Activity, Physician's Global Assessment of Arthritis, CRP (mg/L) and Health Assessment Questionnaire - Disability Index (HAQ-DI). For all visits, if any of the component scores were missing, then those scores were considered as not having met the criteria for improvement.|Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)|ITT Population|||Percentage of participants|||Number
2572584|NCT02504671|Secondary|Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points|DAS28(CRP) scores were categorized using EULAR response criteria. Response at a given time point was defined based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to Baseline. The definition of no response, moderate response and good response was as follows: Current DAS28 <=3.2 and DAS28 decrease from Baseline (>1.2=good response), (>0.6 to <=1.2 = moderate response) and (<=0.6 =no response). Current DAS28 >3.2 to <=5.1 and DAS28 decrease from Baseline value (>1.2 =moderate response), (>0.6 to <=1.2 = moderate response) and (<=0.6 =no response). Current DAS28 >5.1 and DAS28 decrease from Baseline value (>1.2=moderate response), (>0.6 to <=1.2 = no response) and (<=0.6 =no response). If the post-Baseline DAS28(CRP) score was missing, then the corresponding EULAR category was set to missing.|Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)|ITT Population|||Percentage of participants|||Number
2572585|NCT02504671|Secondary|Time to First DAS28(CRP) Remission|The DAS index combines information relating to the number of swollen and tender joints. The DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96. Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 mm visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome). Median time, to remission has been presented.|Up to Week 62|ITT Population. Only those participants with data available at the time of assessment were analyzed.|||Weeks||Full Range|Median
2572596|NCT02504554|Secondary|Vineland Adaptive Behavior Scale (VABS)|The VABS is an assessment of adaptive behaviors, and we analyzed it to determine the developmental age of the participants, with possible scores ranging from 0 years to 21 years.|baseline and 18 weeks (8 weeks after treatment stopped)|We report the data on all participants, regardless of how they received the initial dose of bacteria.|||years||Standard Deviation|Mean
2572597|NCT02504554|Secondary|Short Sensory Profile|"The Short Sensory Profile is an assessment of sensory problems.~However, the data on this scale was not collected due to administrative error."|baseline and 10 weeks|Due to a logistical error, this data was not collected||||||
2572586|NCT02504671|Secondary|Change From Baseline in DAS28(CRP) at All Assessment Time Points|DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96. Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 mm visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome). Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline.|Baseline and Weeks 1, 2, 4, 6, 8, 12, 16, 20 and 24|ITT Population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).|||Scores on a scale||Standard Error|Least Squares Mean
2572587|NCT02504671|Secondary|Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points|DAS28(CRP) remission is defined as a DAS28 score of <2.6 points. The DAS index combines information relating to the number of swollen and tender joints. The DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96. Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 mm visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome).|Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)|ITT Population|||Percentage of participants|||Number
2572588|NCT02504671|Secondary|Change From Baseline in DAS28(CRP) at Week 12|DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96. Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant global assessment of disease activity (PtGA) using a 100 mm visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome). Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.|Baseline and Week 12|ITT Population. Only those participants with data available at the indicated time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2572589|NCT02504671|Primary|Percentage of Participants Who Achieved Disease Activity Score for 28 Different Joints With C-reactive Protein Value (DAS28{CRP}) Remission (DAS28 <2.6) at Week 24|DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96. Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 millimeter [mm] visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in [milligrams/liter] mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome). ITT population comprised of all participants who were randomized to treatment and who received at least one dose of study treatment (GSK3196165 or placebo).|Week 24|ITT Population|||Percentage of participants|||Number
2572590|NCT02504645|Post-Hoc|Proportion of Responders of EU Patients Having Anti-dsDNA ar Randomization|"EU patients who had an assessment of Yes for anti-dsDNA at randomization and responders at week 52"|At week 52|All EU patients who had an assessment of “Yes” for anti-dsDNA at randomization|||percentage of patient responder|||Number
2572591|NCT02504645|Primary|Assessment of Systemic Lupus Erythematosus Responder Index (SRI) at Week 52|"A Systemic lupus erythematosus Responder Index (SRI) response is defined as a reduction from baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of at least 4 points, no worsening in Physician's Global Assessment (PhGA) (with worsening defined as an increase in PhGA of more than 0.30 point from baseline), no new British Isles Lupus Assessment Group A (BILAG A) body system score, and no more than 1 new BILAG B body system score from baseline.~The decrease of 4 points of the SRI is considered as better ouctome."|At week 52|All patients who received at least one study drug.|||percentage of patient responder|||Number
2572592|NCT02504619|Secondary|Percentage of Overall Survival at 365 Days After Transplantation|The percentage of patients alive at one year post-transplant was estimated using the Kaplan-Meier method.|365 days||||Participants|||Count of Participants
2572593|NCT02504619|Primary|The Percentage of Patients With Donor-derived Engraftment at 42 Days Following Transplantation|One hundred percent of patients engrafted by day forty-two post-transplantation with donor-derived cells.|42 days||||Participants|||Count of Participants
2572594|NCT02504619|Primary|Number of Participants With no Acute Toxicity Associated With the Infusion of CordIn, Within 24 Hours Post-infusion.|The number of patients with grade 4 or 5 toxicity were estimated together with 95% confidence limits based on the binomial distribution. The proportion with toxicity grades 1, 2, and 3 was also estimated.|24 hours||||Participants|||Count of Participants
2572595|NCT02504554|Secondary|Daily Stool Record (DSR)|The DSR is a record of the type of stool that a participant had each day, using the Bristol Stool Form which ranges from 1 (very hard) to 7 (liquid). We then analyzed the data as % days of abnormal stools over a 14 day period, where an abnormal stool is defined as an unusually hard stool (types 1-2), unusually soft stool (types 6-7), or no stool that day. So, the possible range of % days of abnormal stools is from 0% to 100%, with a higher score indicating a more severe problem.|Baseline and 10 weeks (end of treatment)|We report the data on all participants, regardless of how the initial dose of bacteria was administered.|||percentage of days with abnormal stool||Standard Deviation|Mean
2572598|NCT02504554|Secondary|Social Responsiveness Scale (SRS)|The SRS is an assessment of social skills based on 65 items, where each item is scored on a range of 0 (no symptoms) to 3 (severe symptoms). The total score is a sum of the individual scores, so the total possible range is from 0 to 195, with a higher score indicating greater severity of symptoms.|Baseline and 10 weeks (end of treatment)|We report the data on 18 participants, regardless of how the initial dose of bacteria was administered.|||units on a scale||Standard Deviation|Mean
2572599|NCT02504554|Secondary|Childhood Autism Rating Scale (CARS)|The CARS is an assessment of 15 autism-related symptoms. Each item is scored on a scale of 1 (no symptoms) to 4 (severe symptoms), and the scores for each symptom are summed to obtain a total score. So, the possible scores range from 15 to 60, with a higher score indicating greater severity.|Baseline and 10 weeks (end of treatment)|We report the data on all participants, regardless of how the initial dose of bacteria was administered.|||units on a scale||Standard Deviation|Mean
2572600|NCT02504554|Secondary|Blood Safety Markers (Assessment of Blood Chemistry Panel and Complete Blood Count)|Number of participants who had a clinically significant change in their blood safety markers (comprehensive metabolic panel including kidney/liver function and complete blood count with differential)|Baseline and 10 weeks (end of treatment)|We report the data on 18 participants, regardless of how the initial dose of bacteria was administered.|||participants|||Number
2572601|NCT02504554|Secondary|Parent Global Impressions-Revised (PGI-R)|The PGI-R is a rating of change of 18 autism symptoms compared to baseline, with each symptom rated on a Likert scale from -3 (much worse) to zero (no change) to +3 (much better). We report the average change of the 18 symptoms, so the possible range is from -3 to +3.|Baseline and 10 weeks (end of treatment)|We report the data on all participants regardless of how the initial dose of bacteria was administered.|||units on a scale||Standard Deviation|Mean
2572602|NCT02504554|Primary|Gastrointestinal Symptom Responsiveness Scale (GSRS)|The GSRS is a measure of gastrointestinal symptoms. It includes 15 questions, rated on a Likert scale of 1-7, from no symptoms to severe symptoms, respectively (i.e., higher is worse). We report an average score for all 15 questions, so the possible range for the average score is also 1-7.|Baseline and 10 weeks (end of treatment)|We report the data on all participants, regardless of how the initial dose of bacteria was administered (oral or rectal).|||units on a scale||Standard Deviation|Mean
2572603|NCT02504541|Primary|Incidence of Adverse Events as a Measure of Safety of QuickShot™ Testosterone (QST) Administered Subcutaneously (SC) Once Each Week to Adult Males With Hypogonadism|"Number of participants experiencing adverse events that started on or after the first dose of QST, or existed prior to the first dose and woresened in severity or relatedness to QST after dosing, were evaluated in this population.~Although a patient may have had 2 or more TEAEs or SAEs, the patient was counted only once within a SOC category. The same patient may have contributed to 2 or more preferred term categories. (Four patients had a total of 9 SAEs during the study)"|26 weeks||||Participants|||Count of Participants
2572604|NCT02504502|Primary|Satisfaction With Genomic Test Report|3 questions on how helpful various parts of the test report were for parents who opened the enhanced report.|3 months after receipt of enhanced report|"parents who opened the enhanced report per electronic confirmation. For Clinical care then enhanced report N=4 CV; 2NCV - these 2 NCV parents did not answer the survey questions about the report (missing). For routine care with enhanced report first N=9 NCV."|||Participants|||Count of Participants
2572605|NCT02504424|Secondary|Number of Breast With Successful Tissue Expansion With Exchange to Permanent Implant Including All Breasts in the Per Protocol Cohort.|Secondary analysis is repeated including all breasts in the PP cohort (including non-device related failures). The Treatment Success Rate by breast, based on the Per Protocol cohort, including all cause failures, is 95.2% (80/84). One subject (2 breasts) are not included in the analyses due to not completing the second stage surgery and withdrawal of consent.|6 months|Analysis population includes all treated breasts with the exception of 2 breasts that were not exchanged at the time of study completion (subject withdrew from study)|||breasts|breasts||Count of Units
2572606|NCT02504424|Primary|Number of Breasts With Successful Tissue Expansion With Exchange to a Permanent Breast Implant Unless Exchange is Precluded by a Non-device Related Event|The primary endpoint is analyzed per breast. Breasts in which the expander is removed and/or replaced due to a device related adverse event or a device malfunction are counted as failures.|6 months|"of participants is 48: # treated (50) minus participant failed exchange of both breasts for non-device related reason (1) and participant not analyzed due to withdrawal (1).~of breasts is 80: # breasts treated (86) minus # breasts failed exchanged due to non-device related reason (4) and # breasts not analyzable due to withdrawal (2)."|||breasts|breasts||Count of Units
2572607|NCT02504320|Primary|Mean AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat|AUC∞ is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|Participants with valid parameters for Regimen D and at least one of the test regimen were included in the analyses for this outcome measure. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
2572608|NCT02504320|Primary|Mean AUCt: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Febuxostat|AUCt is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration.|Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|Participants with valid parameters for Regimen D and at least one of the test regimen were included in the analyses for this outcome measure. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
2572609|NCT02504320|Primary|Mean Cmax: Maximum Observed Plasma Concentration for Febuxostat|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose|Participants with valid parameters for Regimen D and at least one of the test regimen were included in the analyses for this outcome measure. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2573149|NCT02498821|Secondary|Number of Subsequent Malposition Attempts|This is the number of remaining malpositions following the first malposition adjustment attempt. All PICCs were inserted properly after the second malposition adjustment attempt.|Measured from initiation to completion of procedure (usually from 0 to 300 minutes)||||malposition adjustment attempts|||Number
2572612|NCT02504268|Secondary|Percentage of Subjects in Boolean Remission at Week 52|Boolean Remission is defined as Tender joint count less than 1, Swollen joint count less than 1, CRP less than 1 mg/dL, patient global assessment less than 1 (on 0 to 10 VAS scale). Logistic regression was used for this endpoint.|Week 52|Cohort 1 analysis population included all randomized and treated subjects in the Induction Period. Intention to treat analysis. Non-Responder imputation.|||Percentage of Subjects||95% Confidence Interval|Number
2572613|NCT02504268|Secondary|Mean Change From Baseline in Radiographic Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijide Total Sharp Scores (TSS) at Week 52|The Modified Total Sharp Score (mTSS) is calculated as the bilateral sum of erosion and Joint Space Narrowing (JSN) scores across all joints of the hands and feet.The score range for mTSS is 0-448. Higher scores indicate more joint damage. The mean change from baseline in TSS using modified Sharp/van der Heijide scores was assessed using a rank-based nonparametric ANCOVA model.|Week 52|Cohort 1 analysis population included all randomized and treated subjects in the Induction Period. Intention to treat analysis. Linear extrapolation imputation.|||Total Sharp Score||Standard Deviation|Mean
2572614|NCT02504268|Secondary|Percentage of Subjects in SDAI Remission at Week 52|Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI <= 3.3. Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI <= 3.3 indicates disease remission and SDAI >26 = high disease activity.|Week 52|Primary analysis population included the first 50 Japanese and 325 rest of world (ROW) randomized and treated subjects in cohort 1 in the Induction Period. Intention to treat analysis. Non-Responder imputation.|||Percentage of Subjects||95% Confidence Interval|Number
2572615|NCT02504268|Secondary|Percentage of Subjects in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24|DAS28-CRP = Disease Activity Score 28 based on C-reactive protein DAS28-CRP Remission is defined as DAS28-CRP <= 2.6 Using a logistic regression model that includes treatment arm, stratification variable and baseline measure as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided.|Week 24|Primary analysis population included the first 50 Japanese and 325 rest of world (ROW) randomized and treated subjects in cohort 1 in the Induction Period. Intention to treat analysis. Non-Responder imputation.|||Percentage of Subjects||95% Confidence Interval|Number
2572616|NCT02504268|Primary|Percentage of Subjects in Simple Disease Activity Index (SDAI) Remission at Week 24|"Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI <= 3.3.~Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI <= 3.3 indicates disease remission and SDAI >26 = high disease activity."|Week 24|Primary analysis population included the first 50 Japanese and 325 rest of world (ROW) randomized and treated subjects in cohort 1 in the Induction Period. Intention to treat analysis. Non-Responder imputation.|||Percentage of Subjects||95% Confidence Interval|Number
2572617|NCT02504099|Secondary|Percentage of Participants With Recurrent HCV Infection Post Liver Transplant|The percentage of participants with recurrent HCV infection post liver transplant out of all participants with liver transplant during the study.|from liver transplant to 24 weeks post-treatment (up to 48 weeks)|The data collected were not sufficient to analyze primary or secondary outcome measures. Only safety data were reported.||||||
2572618|NCT02504099|Secondary|Percentage of Participants With Long Term Clinical Outcomes|The percentage of participants with long term clinical outcomes (de novo hepatocellular carcinoma (HCC) lesions, liver decompensation, unexpected liver transplant, liver related death, or any of the above) from first dose of study drug through 24 weeks post-treatment follow-up.|up to 48 weeks|The data collected were not sufficient to analyze primary or secondary outcome measures. Only safety data were reported.||||||
2572619|NCT02504099|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|The data collected were not sufficient to analyze primary or secondary outcome measures. Only safety data were reported.||||||
2572620|NCT02504099|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ throughout treatment with at least 6 weeks of treatment.|Baseline (Day 1) and Treatment Weeks 2, 4, 8, 12 (end of treatment for 12-week treatment), 16, 20 and 24 (end of treatment for 12-week treatment)|The data collected were not sufficient to analyze primary or secondary outcome measures. Only safety data were reported.||||||
2572621|NCT02504099|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after flanking imputation were imputed as nonresponders.|12 weeks after the last actual dose of study drug|The data collected were not sufficient to analyze primary or secondary outcome measures. Only safety data were reported.||||||
2572622|NCT02504073|Primary|Number of Hypotheses Observed|This outcome is a result of the third part of the questionnaire: 1) What Gait Abnormalities do You See? 2) What do You Consider the Main Problem (1 Sentence) 3) What is Your Hypothesis (Max. 3) By consensus the three independent researchers identified and categorised all the listed hypotheses from question number three of the questionnaire. After that the use frequency of each item was analysed globally and for each patient.|up to 2 months||||Number of different hypotheses|||Number
2572623|NCT02504073|Primary|Number of Main Problems Observed|This outcome is a result of the second part of the Questionnaire: 1) What Gait Abnormalities do You See? 2) What do You Consider the Main Problem (1 Sentence) 3) What is Your Hypothesis (Max. 3) By consensus the three independent researchers identified the main statements from the sentences written. Items were afterwards categorised. Finally the frequency of each item was analysed globally and for each patient.|up to 2 months||||number of different main problems|||Number
2572624|NCT02504073|Primary|Number of Gait Abnormalities Observed|"The questionnaire will be the basis of this study as it will be the basis for open coding. It is handed out to 54 observers (=physiotherapists) and will be filled in 6 times (for 6 patient videos).~The questionnaire consists of 3 main questions:~what gait abnormalities do you see?~What do you consider the main problem (1 sentence)~what is your hypothesis (max. 3) The question one delivers different items (each new observation is a new item) that were determined patient by patient and rater by rater by three independent researchers. They were then listed and categorised by consensus. Finally, the frequency of each item was analysed globally and for each patient."|up to 2 months||||number of different gait abnormalities|||Number
2572625|NCT02503982|Primary|Area Under the Curve (AUC)|Valganciclovir area under the curve (AUC) calculated with the trapezoidal method using drug levels measured at 2, 5 and 10 h, and extrapolated beyond the 10 hour time point to arrive at a 24-hour curve.|drug levels measured at 2, 5 and 10 h following administration of the dose on day 4 creating a 24 hours curve||||mcg∙h/mL||Inter-Quartile Range|Median
2572626|NCT02503865|Secondary|Immunoassay Cortisole in Blood|Immunoassay Cortisole in the blood (nmole/L) was measured|up to 12 weeks||||nmol/L||Standard Error|Mean
2572627|NCT02503865|Secondary|Immunoassay Hormones in Blood|Immunoassay Insulin in the blood (in nU/L) was investigated|up to 12 weeks||||nU/L||Standard Error|Mean
2572628|NCT02503865|Secondary|Lipid Profile|Blood sample for lipid profile (Cholesterol in mmole/L, High-density Lipoproteids in mmole/L, Triglycerides in mmole/L) was measured|up to 12 weeks||||mmole/L||Standard Error|Mean
2572629|NCT02503865|Primary|Systolic/ Diastolic Blood Pressures (mm Hg)|Systolic and Diastolic Blood Pressures (mm Hg) was measured by manual/automatic tonometery|up to 12 weeks||||mm Hg||Standard Error|Mean
2572630|NCT02503865|Primary|Blood Glucose Level|Fasting blood glucose (FBG) (mmole/L) and Two-hour postprandial glucose (THPG) (mmole/L) were measured.|up to 12 weeks||||mmole/L||Standard Error|Mean
2572631|NCT02503852|Secondary|Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 4|Percent of positive responses, defined by increase of 1 or more from baseline, on specific written assessment of treatment outcome by Investigators scored 1-5, value 1 is lowest, value of 5 is highest, higher values represent more positive responses|Enrollment to 24 weeks|The Baseline NW3 subgroup included all male subjects with baseline Norwood Scale III, III-A and III-V.|||% of participants with + responses|||Number
2572632|NCT02503852|Secondary|Terminal (Non-Vellus) Hair Count--Change From Baseline|Terminal (Non-Vellus) Hair Count Assessment by Macrophotography|Enrollment to 52 weeks|mITT, Baseline Norwood-Hamilton III|||Hairs||Standard Error|Mean
2572633|NCT02503852|Primary|Safety & Tolerability Assessment of SAE/AE|Safety & Tolerability of Experimental Treatment (ADRC) Assessment of SAE/AE|Enrollment to 52 weeks||||events|||Number
2572634|NCT02503787|Other Pre-specified|Change in Average Leg Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire|Self reported daily average leg pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).|From baseline to 3 months post device activation||||units on a scale||Standard Deviation|Mean
2572635|NCT02503787|Other Pre-specified|Change in Average Back Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire|Self reported daily average back pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).|From baseline to 3 months post device activation||||units on a scale||Standard Deviation|Mean
2572636|NCT02503787|Secondary|Patient Global Impression of Change|Evaluate study subject impression of change as measured by the Patient Global Impression of Change questionnaire. The questionnaire encompasses change in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, scored on a scale of 1-7 (1=no change or the condition has gotten worse: 7=A great deal better, and a considerable improvement that has made all the difference).|From baseline to 3 months post device activation||||Participants|||Count of Participants
2572637|NCT02503787|Primary|Change in Average Overall Pain as Measured by the Diary-reported Numeric Pain Rating Scale (NPRS) Questionnaire|Self reported daily average overall pain score 5 days prior to baseline and at 3 months post device activation in subjects receiving programming options in spinal cord stimulation. The question is scored 0-10 (0=no pain; 10=pain as bad as can be).|From baseline to 3 months post device activation||||units on a scale||Standard Deviation|Mean
2572638|NCT02503735|Secondary|Change in Urinary β-2microglobulin Levels After Therapy|"Change in urinary β-2microglobulin levels after therapy with ledipasvir/sofosbuvir fixed dose combination pill~β-2microglobulin (mcg/L) levels were assessed at baseline (timepoint week 0) and at timepoint week 24. Change was recorded for each patient, and presented as a median with IQR."|24 weeks||||mcg/L||Inter-Quartile Range|Median
2572639|NCT02503735|Secondary|Change in Urinary β-2microglobulin Levels Before Therapy|"Change in urinary β-2microglobulin levels before therapy with ledipasvir/sofosbuvir fixed dose combination pill.~β-2microglobulin (mcg/L) change prior to initiating HCV-treatment.~This outcome was not assessed."|24 weeks|"Data were not collected and the outcome cannot be reported. Values for urinary β-2microglobulin were obtained at baseline and not at screening. Thus we are unable to report a change in urinary β-2microglobulin levels BEFORE therapy with ledipasvir/sofosbuvir - however, we are able to report the changes after therapy as followup values were done."||||||
2572640|NCT02503735|Secondary|Median Change in eGFR From Baseline to Timepoint Week 52|"Median change from baseline (timepoint week 0) to timepoint week 52, which was 40 weeks after completion of Harvoni.~Median change in eGFR was calculated using the creatinine and cystatin C-based estimating equation.~eGFR = 135 × min(SCr/κ, 1)α × max(SCr/κ, 1)-0.601 × min(Scys/0.8, 1)-0.375 × max(Scys/0.8, 1)-0.711 × 0.995Age × 0.969 [if female] × 1.08 [if black]"|52 weeks|Sofosbuvir/Ledipasvir FDC: 12 weeks treatment with Harvoni (10 total dosed on protocol)|||mL/min/1.73m^2||Inter-Quartile Range|Median
2572641|NCT02503735|Secondary|Mean Time in Weeks to Maximum Reduction in Proteinuria|This outcome evaluated all post-baseline proteinuria values through the 52 week followup, and determined which demonstrated the greatest negative change (reduction) from baseline. We then calculate the mean time to maximum reduction of proteinuria.|52 weeks|Because 3 patients had rising proteinuria they are not included in this analysis, which only looks at the mean time to reduction in proteinuria in the 7 patients who had any reductions in proteinuria. This includes the 3 patients who had -25% change in proteinuria and 4 patients who had smaller negative changes (reductions) in proteinuria.|||weeks||Standard Deviation|Mean
2572642|NCT02503735|Secondary|Number of Participants With ≥25% Reduction in Proteinuria|Number of participants with at least -25% change in proteinuria, calculated from baseline (timepoint week 0) to timepoint week 24, which is 12 weeks after completion of Harvoni.|24 weeks||||Participants|||Count of Participants
2572643|NCT02503735|Secondary|Median Change in eGFR From Baseline to Timepoint Week 24|"Median change from baseline (timepoint week 0) to timepoint week 24, which was 12 weeks after completion of Harvoni.~Median change in eGFR was calculated using the creatinine and cystatin C-based estimating equation.~eGFR = 135 × min(SCr/κ, 1)α × max(SCr/κ, 1)-0.601 × min(Scys/0.8, 1)-0.375 × max(Scys/0.8, 1)-0.711 × 0.995Age × 0.969 [if female] × 1.08 [if black]"|24 weeks||||mL/min/1.73m^2||Inter-Quartile Range|Median
2572644|NCT02503735|Primary|The Percent Change in Proteinuria|% change in proteinuria from baseline (timepoint week 0) through timepoint week 24, which was 12 weeks after completion of Harvoni.|Baseline and 24 weeks (12 weeks after completion of Harvoni)||||percentage change from baseline||Inter-Quartile Range|Median
2572645|NCT02503540|Secondary|Mean Change From Baseline Central Subfield Thickness||12 months||||μm||Standard Deviation|Mean
2572646|NCT02503540|Secondary|Number of Patients That Showed Visual Acuity 20/200 or Worse||12 months||||Participants|||Count of Participants
2572647|NCT02503540|Secondary|Number of Patients That Showed Visual Acuity 20/40 or Better||12 months||||Participants|||Count of Participants
2572648|NCT02503540|Secondary|Number of Participants Who Lost 15 ETDRS Letters or More of Vision||6 months||||Participants|||Count of Participants
2572649|NCT02503540|Secondary|Number of Participants Who Lost 15 ETDRS Letters or More of Vision||12 months||||Participants|||Count of Participants
2572650|NCT02503540|Secondary|Incidence and Severity of Ocular Adverse Events (AEs) and Serious AEs.||6 and 12 months||||Participants|||Count of Participants
2572651|NCT02503540|Secondary|Number of Patients That Showed Visual Acuity 20/200 or Worse||6 months||||Participants|||Count of Participants
2572652|NCT02503540|Secondary|Number of Patients That Showed Visual Acuity 20/40 or Better||6 months||||Participants|||Count of Participants
2572653|NCT02503540|Secondary|Number of Patients Who Gained 15 ETDRS Letters or More of Vision||6 months||||Participants|||Count of Participants
2572654|NCT02503540|Secondary|Number of Participants Who Gained 15 ETDRS Letters or More of Vision||12 months||||Participants|||Count of Participants
2572655|NCT02503540|Secondary|Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) Score|Mean change from baseline in best-corrected visual acuity (BCVA) score from baseline to month 12|12 months||||ETDRS letters||Standard Deviation|Mean
2572656|NCT02503540|Secondary|Mean Change From Baseline Central Subfield Thickness||6 months||||μm||Standard Deviation|Mean
2572657|NCT02503540|Secondary|Change in Panretinal Ischemic Index From Baseline at 6 Months|Change in panretinal ischemic index (defined as the proportion of retinal area with nonperfusion) from baseline at 6 months|6 months||||percentage of region of interest in UWFA||Standard Deviation|Mean
2572658|NCT02503540|Secondary|Change in Panretinal Ischemic Index|Change in panretinal ischemic index from baseline to postoperative month 12|12 months||||percentage of region of interest in UWFA||Standard Deviation|Mean
2572659|NCT02503540|Secondary|Mean Change in Total Leakage Index|Mean change in total leakage index from baseline to month 12|6 months||||percentage of region of interest in UWFA||Standard Deviation|Mean
2572660|NCT02503540|Primary|Change in Panretinal Leakage Index at Month 12 From Baseline|Change in panretinal leakage index (defined as the proportion of retinal area involved in angiographic leakage) at month 12 from baseline as measured by ultra-widefield angiography (UWFA).|12 months|Monthly aflibercept for 6 months and then every other month for 6 months.|||percentage of region of interest in UWFA||Standard Deviation|Mean
2572661|NCT02503501|Primary|Change in Functional Performance as Measured by the Functional Activities Questionnaire (FAQ)|The FAQ measures instrumental activities of daily living (IADLs), such as preparing balanced meals and managing personal finances. The FAQ is a sum of scores ranging from 0 (normal) to 30 (complete dependence on others).|Baseline and 6 months||||score on a scale||Standard Deviation|Mean
2572662|NCT02503501|Primary|Change in Functional Performance as Measured by the Clinical Dementia Rating (CDR) Scale|The CDR is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias: Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care. Possible scores on the CDR are 0 (no impairment), 0.5 (very mild), 1 (mild), 2 (moderate), and 3 (severe). The total CDR ratings for each of the six cognitive/functional domains can be added to create a CDR sum of boxes (SOB). The overall SOB score ranges from 0 to 18; with 18 indicating severe impairment and 0 indicating no impairment.|Baseline and 6 months||||score on a scale||Standard Deviation|Mean
2572663|NCT02503501|Primary|Change in Cognition as Measured by the Alzheimer's Disease Assessment Scale - Cognitive 13 (ADAS-Cog 13)|The ADAS-Cog was developed as an outcome measure for global cognition in clinical trials for Alzheimer's disease. The ADAS-Cog assesses multiple cognitive domains including memory, language, praxis, and orientation. The modified ADAS-Cog 13-item scale includes all original ADAS-Cog items with the addition of a number cancellation task and a delayed free recall task, for a total of 85 points (0: no cognitive impairment; 85: severe impairment).|Baseline and 6 months||||score on a scale||Standard Deviation|Mean
2572724|NCT02502487|Secondary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients' pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|at cystoscopic inspection of penile and bulbar urethra||||units on a scale||Inter-Quartile Range|Median
2572664|NCT02503410|Secondary|SF36 at 8 Weeks|The SF36 is a clinical outcome measure based on the administration of a questionnaire inquiring about the quality of life and health status of the subject. It consists of eight normalized (so that they have the some weight) scores related to vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. The lower the score the more disability. The higher the score the less disability. The score is provide as units on a scale from 0 to 100|Change in clinical score at 8 weeks||||units on a scale||Standard Deviation|Mean
2572665|NCT02503410|Secondary|SF36 at 4 Weeks|The SF36 is a clinical outcome measure based on the administration of a questionnaire inquiring about the quality of life and health status of the subject. It consists of eight normalized (so that they have the some weight) scores related to vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. The lower the score the more disability. The higher the score the less disability. The score is provide as units on a scale from 0 to 100.|Change in clinical score at 4 weeks||||units on a scale||Standard Deviation|Mean
2572666|NCT02503410|Secondary|Oswestry Low Back Pain Disability Questionnaire at 8 Weeks|Subjects are asked to fill in a questionnaire inquiring about how their pain interferes with their activities of daily living. Accordingly, they receive a disability score ranging between 0 and 100%. A score between 0 and 20% indicates minimal disability; a score between 21 and 40% indicates moderate disability; a score between 41 and 60% indicates severe disability; a score between 61 and 80% indicates that pain impinges on all aspects of the patient's life; and score between 81 and 100% indicates that the subject is bed-bound.|Change in disability score at 8 weeks||||percentage disability||Standard Deviation|Mean
2572667|NCT02503410|Secondary|Oswestry Low Back Pain Disability Questionnaire at 4 Weeks|Subjects are asked to fill in a questionnaire inquiring about how their pain interferes with their activities of daily living. Accordingly, they receive a disability score ranging between 0 and 100%. A score between 0 and 20% indicates minimal disability; a score between 21 and 40% indicates moderate disability; a score between 41 and 60% indicates severe disability; a score between 61 and 80% indicates that pain impinges on all aspects of the patient's life; and score between 81 and 100% indicates that the subject is bed-bound.|Change in disability score at 4 weeks||||percentage disability||Standard Deviation|Mean
2572668|NCT02503410|Primary|Pain Frequency at 8 Weeks|Subjects are asked how many days they experienced low back pain during the week prior to the study visit.|Change in pain frequency at 8 weeks||||days||Standard Deviation|Mean
2572669|NCT02503410|Primary|Pain Frequency at 4 Weeks|Subjects are asked how many days they experienced low back pain during the week prior to the study visit.|Change in pain frequency at 4 weeks||||days||Standard Deviation|Mean
2572670|NCT02503410|Primary|Visual Analogue Pain Scale at 8 Weeks|Subjects are asked to indicate their pain level using a visual analog scale, namely they are asked to choose the position on a horizontal line - drawn on a piece of paper - that corresponds to the pain level that they experience. The line is about 10 cm long and is divided into 10 intervals of equal length referred to as units. The minimum value on the scale is zero (meaning no pain). The maximum value on the scale is ten (meaning maximum ever experienced pain).|Change from baseline in VAS score at 8 weeks||||units on a scale||Standard Deviation|Mean
2572671|NCT02503410|Primary|Visual Analogue Pain Scale at 4 Weeks|Subjects are asked to indicate their pain level using a visual analog scale, namely they are asked to choose the position on a horizontal line - drawn on a piece of paper - that corresponds to the pain level that they experience. The line is about 10 cm long and is divided into 10 intervals of equal length referred to as units. The minimum value on the scale is zero (meaning no pain). The maximum value on the scale is ten (meaning maximum ever experienced pain).|Change from baseline in Visual Analogue Pain Scale score at 4 weeks||||units on a scale||Standard Deviation|Mean
2572672|NCT02503254|Primary|Levels of Carboxyhemoglobin (COHb)|"% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population: all randomized subjects who had at least 1 post randomization product use experience (CHTP 1.0 or CC) and had at least 1 non-safety assessment.~However, due to sample issues such as clotting, COHb assessment results could not be generated for some of the subjects."|||percentage of saturation of hemoglobin||95% Confidence Interval|Least Squares Mean
2572673|NCT02503254|Primary|Concentration of S-phenylmercapturic Acid (S-PMA)|"Concentrations measured on Day 5 in urine, adjusted for creatinine.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (CHTP 1.0 or CC) and had at least 1 non-safety assessment."|||pg/mg creat||95% Confidence Interval|Least Squares Mean
2572674|NCT02503254|Primary|Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)|"Concentrations measured on Day 5 in urine, adjusted for creatinine.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (CHTP 1.0 or CC) and had at least 1 non-safety assessment."|||ng/mg creat||95% Confidence Interval|Least Squares Mean
2572675|NCT02503254|Primary|Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)|"Concentrations measured on Day 5 in urine, adjusted for creatinine.~Geometric Least Squares (LS) means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (CHTP 1.0 or CC) and had at least 1 non-safety assessment."|||pg/mg creat||95% Confidence Interval|Least Squares Mean
2572676|NCT02503215|Secondary|Change in Fluid Distribution From Baseline|Segmental and total body water will be non-invasively assessed before sleeping and after awakening by a bioimpedance device (InBody S10 Analyser™, Biospace, South Korea), which will provide information regarding nighttime fluid shift at baseline and after compression stocking use. The amount of water, expressed in liters, is assessed in both extra and intracellular components.|1 week|"Volume distribution evaluated by bioimpedance analysis evaluated fluid shift from the legs at baseline and after wearing compression stockings. The amount overnight fluid that moved rostrally from the legs is depicted below (results expressed as mean ± standard deviation):~Baseline: 571.4 ± 389.6 ml~Compression stockings: 517.9 ± 452.2 ml"|||mililiters||Standard Deviation|Mean
2572677|NCT02503215|Secondary|Change of Heart Rate Variability Change From Baseline|Electrocardiogram performed during polysomnography examination will be downloaded to a specific software for heart rate variability assessment (Kubius HRV™, University of Eastern Finland, Finland), which provides spectral assessment of heart rate variability in its both components: low frequency (LF) and high frequency (HF). Patients who present higher LF/HF during the night compared to the beggining of the polysomnography exam have, by definition, increased sympathetic activity during the night. Such evaluation will be accessed in both baseline and after compression stockings use.|1 week|Overnight increase in LF/HF ratio at baseline: 11/12 patients (92%) Overnight increase in LF/HF ratio after compression stockings use: 7/12 patients (58%)|||percentage of participants|||Number
2572678|NCT02503215|Primary|Change of Obstructive Apnea Severity Index Score From Baseline|"Apnea/Hypopnea index (AIH) was assessed by a validated polysomnography (EMBLA®S4500, Embla Systems Inc., Broomfield, CO, USA) at baseline and 1 week after compression stockings use. The observed results are expressed as median and interquartile range (25,75 percentiles):~AIH at baseline: 20.8 (14.2; 39.6) events/hour;~AIH after compression stockings use: 16.7 (3.5; 28.9) events/hour"|1 week|Apnea/Hypopnea Index|||events/hour||Inter-Quartile Range|Median
2572679|NCT02503202|Primary|Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card|An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Vesicular lesion AEs prompted on the VRC included blister and rash vesicular.|Up to Day 42 postvaccination|Randomized participants who received vaccination and had follow-up data for the outcome measure|||Percentage of participants|||Number
2572680|NCT02503202|Primary|Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card|An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Rash AEs prompted on the VRC were petechial rash, purpuric rash, and vesicular-type rash.|Up to Day 42 postvaccination|Randomized participants who received vaccination and had follow-up data for the outcome measure|||Percentage of participants|||Number
2572681|NCT02503202|Primary|Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card|An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Adverse events of arthralgia and arthritis were prompted on the VRC.|From Day 5 to Day 42 postvaccination|Randomized participants who received vaccination and had follow-up data for the outcome measure|||Percentage of participants|||Number
2572682|NCT02503202|Primary|Percentage of Participants With Elevated Maximum Temperature|Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination through Day 42. Elevated temperature was defined as ≥38.0° C (≥100.4° F).|Up to Day 42 postvaccination|Randomized participants who received vaccination and had follow-up data for the outcome measure|||Percentage of participants|||Number
2572683|NCT02503202|Primary|Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card|An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling.|Up to Day 5 postvaccination|Randomized participants who received vaccination and had follow-up data for the outcome measure|||Percentage of participants|||Number
2572684|NCT02503202|Primary|Percentage of Participants Reporting Serious Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is any other important medical event, is a cancer, or is associated with an overdose.|Up to Month 6 postvaccination|Randomized participants who received vaccination and had follow-up data for the outcome measure|||Percentage of participants|||Number
2572685|NCT02503202|Primary|Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody|Serum was collected for determination of geometric mean titer (GMT) of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibodies using an enzyme-linked immunosorbent assay (GP-ELISA). The unit of measure is ELISA units/mL (EU/mL). The lower limit of quantification for the assay was 36.11 EU/mL.|Day 28 postvaccination|Participants who were compliant with the protocol, received vaccination, were seronegative at Day 1, and had a serum sample collected within the acceptable day range|||EU/mL||95% Confidence Interval|Geometric Mean
2573150|NCT02498821|Secondary|Number of Participants With Malpositions||Measured from initiation to completion of procedure (usually from 0 to 300 minutes)||||Participants|||Count of Participants
2572686|NCT02503085|Secondary|Number of Subjects With Adverse Events (AEs).|"Intensity was determined by the Investigator. For symptomatic AEs the following definitions were applied.~Mild = AE did not limit usual activities; subject may have experienced slight discomfort.~Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort.~Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain.~Relationship to Investigational Medicinal Products (IMP)~Unassessable/Unclassified = Insufficient information to be able to make an assessment.~Conditional/ Unclassified = Insufficient information to make an assessment at present.~Unrelated = No possibility that AE was caused by IMP. Unlikely = Slight, but remote, chance that AE was caused by IMP. Possible = Reasonable suspicion that the AE was caused by IMP. Probable = Most likely that AE was caused by IMP. Certain = AE was definitely caused by IMP."|Up to follow-up day 7|Safety population|||Participants|||Count of Participants
2572687|NCT02503085|Secondary|Plasma Concentration at Each Planned Nominal Time-point (Cn)|Cn was derived using linear interpolation from the 2 samples taken either side of the nominal time where there was a sampling time deviation. For concentrations that were missing due to blood samples not being taken Cn was not derived.|Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)|Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.|||ng/mL||Standard Deviation|Mean
2572688|NCT02503085|Secondary|Plasma Concentration Half-life (T1/2)|Terminal elimination half-life (T1/2) = ln(2)/Kel|Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)|Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.|||min||Standard Deviation|Mean
2572689|NCT02503085|Secondary|Time to Cmax (Tmax)||Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)|Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.|||min||Standard Deviation|Mean
2572690|NCT02503085|Secondary|Ratio of AUC0-t/AUC0-inf (AUCR)||Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)|Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.|||Ratio||Standard Deviation|Mean
2572691|NCT02503085|Secondary|AUC From Administration to Infinity (AUC0-inf)|AUC0-inf = AUC0-t + (Ct/Kel), where Ct was the last quantifiable concentration at time t.|Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)|Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.|||min*ng/mL||Standard Deviation|Mean
2572692|NCT02503085|Secondary|Elimination Rate Constant (Kel)||Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)|Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.|||1/min||Standard Deviation|Mean
2572693|NCT02503085|Primary|Area Under the Plasma Concentration-time Curve From Administration to the Last Quantifiable Concentration at Time t (AUC0-t)||Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)|Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.|||min*ng/mL||Standard Deviation|Mean
2572694|NCT02503085|Primary|Maximum Plasma Concentration (Cmax)||Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)|Analysis population included only subjects with evaluable plasma concentrations per treatment and who had taken at least one dose of medication in each treatment groups.|||ng/mL||Standard Deviation|Mean
2572695|NCT02502864|Other Pre-specified|Comparison of Patient Profiles and Function Assessment of Cancer Therapy (FACT) Scores|The relationship between PK-guided docetaxel patient PK profiles and the Function Assessment of Cancer Therapy (FACT) Taxane and Breast Cancer scores will be described.|Up to 6 months|Descriptive analysis was planned for 52 participants. Due to the small number of participants enrolled, analyzing additional correlations was not possible.||||||
2572696|NCT02502864|Secondary|Association Between Scores - Cumulative Illness Rating Scale for Geriatrics|The Cumulative Illness Rating Scale for Geriatrics (CIRS-G) will be reported as discrete data out of a possible score of 65. The Wilcoxon-Rank sum and Chi-squared tests will be used as appropriate.|Baseline and Post Cycle 1|Descriptive analysis was planned for 52 participants. Due to the small number of participants enrolled, analyzing additional correlations was not possible.||||||
2572697|NCT02502864|Secondary|Association Between Scores - Instrumental Activities of Daily Living|The Instrumental Activities of Daily Living (IADL) total score will be reported as binomial data (greater or less than 26 based on how it is incorporated into the CRASH score).|Baseline and Post Cycle 1|Descriptive analysis was planned for 52 participants. Due to the small number of participants enrolled, analyzing additional correlations was not possible.||||||
2572698|NCT02502864|Secondary|Association Between Scores - Chemotherapy Risk Assessment Scale for High-Age Patients|The Chemotherapy Risk Assessment Scale for High-Age Patients (CRASH) score will be reported as ordinal data (low, intermediate-low, intermediate-high, or high risk).|Baseline and Post Cycle 1|Descriptive analysis was planned for 52 participants. Due to the small number of participants enrolled, analyzing additional correlations was not possible.||||||
2572699|NCT02502864|Secondary|Incidence of Grade 3 and 4 Neutropenia and Febrile Neutropenia|The incidence of grade 3 and 4 neutropenia and febrile neutropenia in cycles following PK adjustment (cycles 2-4) will be compared with cycle 1 and historical non-PK guided therapy using the Wilcoxon-Rank sum assessment.|Up to 6 months|All participants.|||Participants|||Count of Participants
2572700|NCT02502864|Primary|Rate of Achieving Targeted Area Under the Curve (AUC)|Rate of PK guided dosing of docetaxel chemotherapy improving the ability to achieve a targeted AUC ( 2.5-3.7 mg*hr/L) within 4 cycles of therapy in patients > 65 years of age with breast cancer receiving TC (docetaxel and cyclophosphamide) as compared with historical non-PK guided therapy from patients receiving a similar regimen.|Cycle 4 - Up to 6 months|All participants evaluable at time of analysis.|||Participants|||Count of Participants
2572701|NCT02502734|Secondary|Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Event (SAE).|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Number of participants with AEs and SAEs have been presented. Two participants randomized to Sequence 1 (Placebo/FF), were treated with placebo in Period 1; however, neither received FF in Period 2, due to premature withdrawal.|From the start of study treatment until follow-up (assessed up to 54 days)|ITT Population|||Participants|||Number
2572702|NCT02502734|Primary|Mean Growth Rate in Lower-leg Growth, as Determined by Knemometry.|Lower leg growth rate was assessed in growth population as change in the lower leg length from start to end of each 2-week period, divided by time interval (number of days) between the two measurements, multiplied by 7. The Growth Population is defined as the Intent-To-Treat (ITT) population excluding participants having any of the following: did not fulfill growth-specific criteria; did not have growth assessment(s) at any defined time point; withdrawal from study due to adverse events related to major trauma to the legs, major surgery, or severe dehydration; received protocol prohibited medications that may affect short term growth, prior to randomization and during the study; protocol deviations defined in exclusion criteria for growth population. ITT Population consists of all randomized participants who received at least one dose of study drug.|Over a two week (14 day) treatment period for FF 50mcg OD and Placebo respectively.|Growth Population|||millimeter per week||Standard Deviation|Least Squares Mean
2572703|NCT02502526|Secondary|Balanced Salt Solution (BSS) Fluid Used|BSS Fluid was measured by weighing the BSS bag after priming. BSS Used is Incision Leakage Fluid plus Aspiration Fluid Used. A reduction in BSS fluid used implies less induced trauma to tissues. Only one eye (study eye) contributed to the analysis.|Day 0 (operative day)|ITT with non-missing data|||milliliters (ml)||Standard Deviation|Mean
2572704|NCT02502526|Secondary|Cumulative Dissipated Energy (CDE)|Cumulative Dissipated Energy (CDE) represents the energy dissipated of the u/s tip and infusion sleeve at the incision point (5.6mm back from the cutting edge of the tip) during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was present at the incision site. Only one eye (study eye) contributed to the analysis.|Day 0 (operative day)|ITT with non-missing data|||percent-seconds||Standard Deviation|Mean
2572705|NCT02502526|Primary|Cumulative Dissipated Energy (CDE)|Cumulative Dissipated Energy (CDE) represents the energy dissipated of the u/s tip and infusion sleeve at the incision point (5.6mm back from the cutting edge of the tip) during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was present at the incision site. Only one eye (study eye) contributed to the analysis. This outcome measure was pre-specified for CVS Bal and IVS MFK.|Day 0 (operative day)|ITT with non-missing data|||percent-seconds||Standard Deviation|Mean
2572706|NCT02502487|Secondary|Breath Rate After Withdrawal of Cystoscope||after withdrawal of cystoscope||||times per minute||Standard Deviation|Mean
2572707|NCT02502487|Secondary|Breath Rate at Cystoscopic Inspection of External Sphincter||at cystoscopic inspection of external sphincter||||times per minute||Standard Deviation|Mean
2572708|NCT02502487|Secondary|Breath Rate at Cystoscopic Inspection of Penile and Bulbar Urthra||at cystoscopic inspection of penile and bulbar Urthra||||times per minute||Standard Deviation|Mean
2572709|NCT02502487|Secondary|Breath Rate Before Gel Administration||before gel administration||||times per minute||Standard Deviation|Mean
2572710|NCT02502487|Secondary|Oxygen Saturation by Pulse After Withdrawal of Cystoscope||after withdrawal of cystoscope||||percentage||Inter-Quartile Range|Median
2572711|NCT02502487|Secondary|Oxygen Saturation by Pulse at Cystoscopic Inspection of External Sphincter||at cystoscopic inspection of external sphincter||||percentage||Inter-Quartile Range|Median
2572712|NCT02502487|Secondary|Oxygen Saturation by Pulse at Cystoscopic Inspection of Penile and Bulbar Urthra||at cystoscopic inspection of penile and bulbar urthra||||percentage||Inter-Quartile Range|Median
2572713|NCT02502487|Secondary|Oxygen Saturation by Pulse Before Gel Administration||before gel administration||||percentage||Inter-Quartile Range|Median
2572714|NCT02502487|Secondary|Mean Arterial Pressure After Withdrawal of Cystoscope||after withdrawal of cystoscope||||mmHg||Standard Deviation|Mean
2572715|NCT02502487|Secondary|Mean Arterial Pressure at Cystoscopic Inspection of External Sphincter||at cystoscopic inspection of external sphincter||||mmHg||Standard Deviation|Mean
2572716|NCT02502487|Secondary|Mean Arterial Pressure at Cystoscopic Inspection of Penile and Bulbar Urthra||at cystoscopic inspection of penile and bulbar urthra||||mmHg||Standard Deviation|Mean
2572717|NCT02502487|Secondary|Mean Arterial Pressure Before Gel Administration||before gel administration||||mmHg||Standard Deviation|Mean
2572718|NCT02502487|Secondary|Heart Rate After Withdrawal of Cystoscope||after withdrawal of cystoscope||||Beats per minute||Standard Deviation|Mean
2572719|NCT02502487|Secondary|Heart Rate at Cystoscopic Inspection of External Sphincter||at cystoscopic inspection of external sphincter||||Beats per minute||Standard Deviation|Mean
2572720|NCT02502487|Secondary|Heart Rate at Cystoscopic Inspection of Penile and Bulbar Urthra||at cystoscopic inspection of penile and bulbar urethra||||Beats per minute||Standard Deviation|Mean
2572721|NCT02502487|Secondary|Heart Rate Before Gel Administration||before gel administration||||Beats per minute||Standard Deviation|Mean
2572722|NCT02502487|Secondary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients' pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|after withdrawal of cystoscope||||units on a scale||Inter-Quartile Range|Median
2572723|NCT02502487|Secondary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients' pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|at cystoscopic inspection of prostate and bladder||||units on a scale||Inter-Quartile Range|Median
2572725|NCT02502487|Secondary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients' pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|before gel administration||||units on a scale||Inter-Quartile Range|Median
2572726|NCT02502487|Primary|Visual Analog Scale (VAS) for Pain|A visual analog scale (VAS) ranging from 0 to 10 was used to assess the patients' pain during the procedure. 0 means no pain, 1 to 3 means mild pain, 4 to 7 means moderate pain, and 8 to 10 means severe pain. Patients were asked the VAS score to express the degree of pain at each time point.|at cystoscopic inspection of external sphincter||||units on a scale||Inter-Quartile Range|Median
2572727|NCT02502461|Secondary|Number of Participants With Correct Depth of Endotracheal Tube in Trachea,|Endotracheal tube tip >2.5cm from carina and >5.5cm from vocal cords for women and >6cm from vocal cords for men|immediate (within 5minutes of intubation).|Participants removed from analysis were all removed because of unavailable clean bronchoscope.|||Participants|||Count of Participants
2572728|NCT02502461|Primary|Sore Throat|Surrogate measure of tissue damage from moving the tube with cuff inflated = soreness of throat on an 11-point verbal pain scale, with 0 = no pain, and 10 the worst pain imaginable.|when patient awake (within 24 hours of intubation)||||units on a scale||Standard Deviation|Mean
2572729|NCT02502149|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) at 15K Manufacturing Scale|An SAE is any untoward medical occurrence that at any dose: results in death or in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. All major surgeries will be reported as SAEs. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the SAE definition. Number of participants with TESAEs were summarized overall.|Approximately 43 weeks|The population analyzed included all participants who received at least 1 dose of rFVIIIFc at 15k manufacturing scale.|||Participants|||Count of Participants
2572730|NCT02502149|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) at 15K Manufacturing Scale|An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Number of Participants with TEAEs were summarized overall.|Approximately 43 weeks|The population analyzed included all participants who received at least 1 dose of rFVIIIFc at 15k manufacturing scale.|||Participants|||Count of Participants
2572731|NCT02502149|Secondary|Development of Inhibitors as Measured by the Nijmegen-modified Bethesda Assay|An inhibitor test result greater than or equal to (>=)0.6 Bethesda units [BU]/mL, confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. The test was performed by the central laboratory using the Nijmegen-modified Bethesda Assay. An exact 95% confidence interval (CI) for the percentage of participants with a confirmed inhibitor was calculated using the Clopper-Pearson method for a binomial proportion. Percentage of participants with confirmed inhibitor development was summarized overall.|At screening and predose on Day 1, 13 and 26 weeks after PK2 injection or at Early Termination (Approximately 43 weeks)|The population analyzed included all participants who received at least 1 dose of rFVIIIFc.|||percentage of participants||95% Confidence Interval|Number
2572732|NCT02502149|Secondary|Mean Residence Time (MRT) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hours (h)||95% Confidence Interval|Geometric Mean
2572733|NCT02502149|Secondary|Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mL/kg||95% Confidence Interval|Geometric Mean
2572734|NCT02502149|Secondary|Clearance (CL) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||milliliter per hour per kilogram(mL/h/kg||95% Confidence Interval|Geometric Mean
2572813|NCT02501161|Secondary|Change in Haematological Parameter- Basophils|Change in basophils from baseline (week 0) to week 26 and week 104 is presented.|Week 0, week 26, week 104|SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.|||Percentage of basophils||Standard Deviation|Mean
2572735|NCT02502149|Secondary|Half-life (t½) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Time required for the concentration of the drug to reach half of its original value.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Hours (h)||95% Confidence Interval|Geometric Mean
2572736|NCT02502149|Secondary|Maximum Activity (Cmax) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Cmax is defined as maximum activity of rFVIIIFc.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL||95% Confidence Interval|Geometric Mean
2572737|NCT02502149|Secondary|Incremental Recovery (IR) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Incremental Recovery is defined as the increase in the circulating FVIII activity in international unit per deciliter (IU/dL) per unit dose administered in international unit per kilogram (IU/kg) (IU/dL per IU/kg).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
2572738|NCT02502149|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by the Two-stage Chromogenic Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|AUCinf is area under the concentration-time curve from time zero to infinity.|Pre-dose and post dose at: 0.5 hour (hr), 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||IU*h/dL||95% Confidence Interval|Geometric Mean
2572739|NCT02502149|Secondary|Mean Residence Time (MRT) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||hours (h)||95% Confidence Interval|Geometric Mean
2572740|NCT02502149|Secondary|Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||mL/kg||95% Confidence Interval|Geometric Mean
2572741|NCT02502149|Secondary|Clearance (CL) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||mL/h/kg||95% Confidence Interval|Geometric Mean
2572742|NCT02502149|Secondary|Half-life (t½) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Time required for the concentration of the drug to reach half of its original value.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||Hours (h)||95% Confidence Interval|Geometric Mean
2572743|NCT02502149|Secondary|Maximum Activity (Cmax) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Cmax is defined as maximum activity of rFVIIIFc.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL||95% Confidence Interval|Geometric Mean
2572744|NCT02502149|Secondary|Incremental Recovery (IR) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Incremental Recovery is defined as the increase in the circulating FVIII activity in international unit per deciliter (IU/dL) per unit dose administered in international unit per kilogram (IU/kg) (IU/dL per IU/kg).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
2572745|NCT02502149|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by the Two-stage Chromogenic Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|AUCinf is area under the concentration-time curve from time zero to infinity.|Pre-dose and post dose at: 0.5 hour (hr), 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU*h/dL||95% Confidence Interval|Geometric Mean
2572755|NCT02502149|Secondary|Clearance (CL) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK1 and PK2|Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||mL/h/kg||95% Confidence Interval|Geometric Mean
2572746|NCT02502149|Secondary|Mean Residence Time (MRT) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 and PK3|The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hours (h)||95% Confidence Interval|Geometric Mean
2572747|NCT02502149|Secondary|Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured the Two-stage Chromogenic Assay for PK2 and PK3|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mL/kg||95% Confidence Interval|Geometric Mean
2572748|NCT02502149|Secondary|Clearance (CL) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 and PK3|Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mL/h/kg||95% Confidence Interval|Geometric Mean
2572749|NCT02502149|Secondary|Half-life (t½) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 and PK3|Time required for the concentration of the drug to reach half of its original value. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Hours (h)||95% Confidence Interval|Geometric Mean
2572750|NCT02502149|Secondary|Maximum Activity (Cmax) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK2 and PK3|Cmax is defined as maximum activity of rFVIIIFc. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL||95% Confidence Interval|Geometric Mean
2572751|NCT02502149|Secondary|Incremental Recovery (IR) as Measured by the Two-stage Chromogenic Assay for PK2 and PK3|Incremental Recovery is defined as the increase in the circulating FVIII activity in IU/dL per unit dose administered in IU/kg (IU/dL per IU/kg). Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
2572752|NCT02502149|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by the Two-stage Chromogenic Assay for PK2 and PK3|AUCinf is area under the concentration-time curve from time zero to infinity. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||IU*h/dL||95% Confidence Interval|Geometric Mean
2572753|NCT02502149|Secondary|Mean Residence Time (MRT) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK1 and PK2|The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||hours (h)||95% Confidence Interval|Geometric Mean
2572754|NCT02502149|Secondary|Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK1 and PK2|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||mL/kg||95% Confidence Interval|Geometric Mean
2572756|NCT02502149|Secondary|Half-life (t½) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK1 and PK2|Time required for the concentration of the drug to reach half of its original value. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||Hours (h)||95% Confidence Interval|Geometric Mean
2572757|NCT02502149|Secondary|Maximum Activity (Cmax) of rFVIIIFc as Measured by the Two-stage Chromogenic Assay for PK1 and PK2|Cmax is defined as maximum activity of rFVIIIFc. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||IU/dL||95% Confidence Interval|Geometric Mean
2572758|NCT02502149|Secondary|Incremental Recovery (IR) as Measured by the Two-stage Chromogenic Assay for PK1 and PK2|Incremental Recovery is defined as the increase in the circulating FVIII activity in IU/dL per unit dose administered in IU/kg (IU/dL per IU/kg). Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
2572759|NCT02502149|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by the Two-stage Chromogenic Assay for PK1 and PK2|AUCinf is area under the concentration-time curve from time zero to infinity. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||IU*h/dL||95% Confidence Interval|Geometric Mean
2572760|NCT02502149|Secondary|Mean Residence Time (MRT) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hours (h)||95% Confidence Interval|Geometric Mean
2572761|NCT02502149|Secondary|Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mL/kg||95% Confidence Interval|Geometric Mean
2572762|NCT02502149|Secondary|Clearance (CL) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mL/h/kg||95% Confidence Interval|Geometric Mean
2572763|NCT02502149|Secondary|Half-life (t½) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Time required for the concentration of the drug to reach half of its original value.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Hours (h)||95% Confidence Interval|Geometric Mean
2572764|NCT02502149|Secondary|Maximum Activity (Cmax) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Cmax is defined as maximum activity of rFVIIIFc.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL||95% Confidence Interval|Geometric Mean
2572765|NCT02502149|Secondary|Incremental Recovery (IR) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|Incremental Recovery is defined as the increase in the circulating FVIII activity in international unit per deciliter (IU/dL) per unit dose administered in international unit per kilogram (IU/kg) (IU/dL per IU/kg).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
2572810|NCT02501161|Secondary|Change in Calcitonin|The number of participants who reported low, normal and high levels of calcitonin in relation to reference ranges at baseline (week 0), week 26 and week 104 are presented.|Week 0, week 26, week 104|SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.|||Participants|||Count of Participants
2572766|NCT02502149|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by One-stage aPTT Clotting Assay for PK3 at Different Vial Strengths (1000 and 6000 IU/Vial)|AUCinf is area under the concentration-time curve from time zero to infinity.|Pre-dose and post dose at: 0.5 hour (hr), 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||IU*h/dL||95% Confidence Interval|Geometric Mean
2572767|NCT02502149|Secondary|Mean Residence Time (MRT) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||hours (h)||95% Confidence Interval|Geometric Mean
2572768|NCT02502149|Secondary|Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||mL/kg||95% Confidence Interval|Geometric Mean
2572769|NCT02502149|Secondary|Clearance (CL) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||mL/h/kg||95% Confidence Interval|Geometric Mean
2572770|NCT02502149|Secondary|Half-life (t½) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Time required for the concentration of the drug to reach half of its original value.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||Hours (h)||95% Confidence Interval|Geometric Mean
2572771|NCT02502149|Secondary|Maximum Activity (Cmax) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Cmax is defined as maximum activity of rFVIIIFc.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL||95% Confidence Interval|Geometric Mean
2572772|NCT02502149|Secondary|Incremental Recovery (IR) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|Incremental Recovery is defined as the increase in the circulating FVIII activity in international unit per deciliter (IU/dL) per unit dose administered in international unit per kilogram (IU/kg) (IU/dL per IU/kg).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
2572773|NCT02502149|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by One-stage aPTT Clotting Assay for PK2 at Different Vial Strengths (1000 and 6000 IU/Vial)|AUCinf is area under the concentration-time curve from time zero to infinity.|Pre-dose and post dose at: 0.5 hour (hr), 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU*h/dL||95% Confidence Interval|Geometric Mean
2572774|NCT02502149|Secondary|Mean Residence Time (MRT) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 and PK3|The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hours (h)||95% Confidence Interval|Geometric Mean
2572775|NCT02502149|Secondary|Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 and PK3|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mL/kg||95% Confidence Interval|Geometric Mean
2572811|NCT02501161|Secondary|Change in Haematological Parameter- Lymphocytes|Change in lymphocytes from baseline (week 0) to week 26 and week 104 is presented.|Week 0, week 26, week 104|SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.|||Percentage of lymphocytes||Standard Deviation|Mean
2572776|NCT02502149|Secondary|Clearance (CL) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 and PK3|Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||mL/h/kg||95% Confidence Interval|Geometric Mean
2572777|NCT02502149|Secondary|Half-life (t½) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 and PK3|Time required for the concentration of the drug to reach half of its original value. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Hours (h)||95% Confidence Interval|Geometric Mean
2572778|NCT02502149|Secondary|Maximum Activity (Cmax) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK2 and PK3|Cmax is defined as maximum activity of rFVIIIFc. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL||95% Confidence Interval|Geometric Mean
2572779|NCT02502149|Secondary|Incremental Recovery (IR) as Measured by One-stage aPTT Clotting Assay for PK2 and PK3|Incremental Recovery is defined as the increase in the circulating FVIII activity in IU/dL per unit dose administered in IU/kg (IU/dL per IU/kg). Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
2572780|NCT02502149|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by One-stage aPTT Clotting Assay for PK2 and PK3|AUCinf is area under the concentration-time curve from time zero to infinity. Results were summarized overall for 15K rFVIIIFc 1000 IU/Vial and 6000 IU/Vial for PK2 and PK3.|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||IU*h/dL||95% Confidence Interval|Geometric Mean
2572781|NCT02502149|Secondary|Mean Residence Time (MRT) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK1 and PK2|The Mean Residence Time (MRT) is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as area under the first moment curve AUMC (0-infinity)/Area Under the Plasma Concentration-Time Curve AUC (0-infinity), where AUMC (0-infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||hours (h)||95% Confidence Interval|Geometric Mean
2572782|NCT02502149|Secondary|Volume of Distribution at Steady State (Vss) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK1 and PK2|Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||milliliter per kilogram (mL/kg)||95% Confidence Interval|Geometric Mean
2572783|NCT02502149|Secondary|Clearance (CL) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK1 and PK2|Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||milliliter per hour per kilogram(mL/h/kg||95% Confidence Interval|Geometric Mean
2572784|NCT02502149|Secondary|Half-life (t½) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK1 and PK2|Half-life is time required for the concentration of the drug to reach half of its original value. Results were summarized overall for 15K 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||Hours (h)||95% Confidence Interval|Geometric Mean
2572799|NCT02501629|Secondary|Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Responses|"Treatment-emergent responses were defined as a positive sample post-baseline (negative baseline) OR a titer increase of >=4-fold relative to a positive baseline sample.~Two types of antibody assay were performed, an immunogenicity status assay (ADA) and neutralizing assay (NAb).~The ADA assay produces a positive or negative result. For samples with a positive result, a neutralizing assay was performed, which also produces a positive or negative result."|Weeks 4, 8, 12, 24 or early withdrawal.||||Participants|||Count of Participants
2572785|NCT02502149|Secondary|Maximum Activity (Cmax) of rFVIIIFc as Measured by One-stage aPTT Clotting Assay for PK1 and PK2|Cmax is defined as maximum activity of rFVIIIFc. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS is defined as all participants with evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||International units per deciliter (IU/dL||95% Confidence Interval|Geometric Mean
2572786|NCT02502149|Primary|Incremental Recovery (IR) as Measured by One-stage aPTT Clotting Assay for PK1 and PK2|Incremental Recovery is defined as the increase in the circulating FVIII activity in international unit per deciliter (IU/dL) per unit dose administered in international unit per kilogram (IU/kg) (IU/dL per IU/kg). Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hr, 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The PKAS included all participants who have evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||IU/dL per IU/kg||90% Confidence Interval|Geometric Mean
2572787|NCT02502149|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by One-stage Activated Partial Thromboplastin Time (aPTT) Clotting Assay for Pharmacokinetic Assessment 1 (PK1) and Pharmacokinetic Assessment 2 (PK2)|AUCinf is area under the concentration-time curve from time zero to infinity. Results were summarized overall for 15K rFVIIIFc 1000 IU/vial and 6000 IU/Vial (PK2).|Pre-dose and post dose at: 0.5 hour (hr), 1 hr, 6 hr, 24 hr, 48 hr, 72 hr and 96 hr|The Pharmacokinetic Analysis Set (PKAS) included all participants who have evaluable PK profiles. All 24 participants had data available from PK1 and/or PK2 and were included in the analysis model for this outcome. Hence, the data for 24 participants has been reported for PK2.|||International unit*hour per deciliter||90% Confidence Interval|Geometric Mean
2572788|NCT02502071|Primary|Change in Number of Participants With Urine Uric Acid Precipitation by Polarized Microscopy||Day 1 (pre-therapy) and Day 2 (post-therapy)||||participants|||Number
2572789|NCT02502071|Primary|Change in Urine Uric Acid Concentration (Increased Solubility) by Assay||Day 1 (pre-therapy) and Day 2 (post-therapy)||||mg/dl||95% Confidence Interval|Geometric Mean
2572790|NCT02502019|Secondary|Adverse Events|Incidence of adverse events through final follow-up|6 +/- 2 weeks after implant||||Participants|||Count of Participants
2572791|NCT02502019|Secondary|Hemostasis Within 3 Minutes|Proportion of subjects achieving hemostasis within 3 minutes of HEMOBLAST™ Bellows application|Intraoperative||||Participants|||Count of Participants
2572792|NCT02502019|Secondary|Hemostasis Within 10 Minutes|Proportion of subjects achieving hemostasis within 10 minutes of HEMOBLAST™ Bellows application|Intraoperative||||Participants|||Count of Participants
2572793|NCT02502019|Secondary|Hemostatic Within 6 Minutes|Proportion of subjects achieving hemostasis within 6 minutes of HEMOBLAST™ Bellows application|Intraoperative||||Participants|||Count of Participants
2572794|NCT02502019|Primary|Mean Paired Kappa Statistic for the Assignment of SBSS Scores by 2 Investigators|The primary endpoint of this clinical investigation is the mean paired Kappa statistic for the assignment of SBSS scores by 2 Investigators.|Intraoperative||||Kappa statistic|||Number
2572795|NCT02501759|Primary|Sensitivity of TRUS-guided Biopsy|The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard. For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated. The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar's test. To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.|Up to 2 weeks after MRI-guided biopsy|Due to low enrollment, insufficient data was collected to report this outcome||||||
2572796|NCT02501759|Primary|Sensitivity of MRI-guided Biopsy|The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard. For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated. The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar's test. To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.|Up to 2 weeks after diagnostic MRI|Due to low enrollment, insufficient data was collected to report this outcome||||||
2572797|NCT02501759|Primary|Proportion of MRI-guided Biopsies That Demonstrate a Higher Gleason Score Than Contemporaneous TRUS Guided Biopsy|The proportion of MRI-guided biopsies that demonstrate a higher Gleason score than contemporaneous TRUS guided biopsy for all patients diagnosed of prostate cancer based on the reference standard will be estimated. McNemar's test will be used to assess whether the MRI-guided biopsies are more likely to yield a higher Gleason score compared with TRUS guided biopsy. Simple logistic regression model will be used to assess the association between the higher Gleason score and patient characteristics and/or clinical information for patients diagnosed of prostate cancer.|Up to 42 days (6 weeks)|Due to low enrollment, insufficient data was collected to report this outcome||||||
2572798|NCT02501629|Secondary|Participants With Adverse Events|"An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product, regardless of whether it has a causal relationship with this treatment. In this study, asthma exacerbations (which are efficacy parameters) should not be recorded as adverse events unless assessed by the investigator as more severe than the patient's usual disease course. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.~Treatment-related adverse events or adverse events related to OCS use included events with missing relationship to study drug or OCS use, respectively."|Day 1 up to Week 24 (end of treatment visit); Data were included between Day 1 and Week 24 for completed patients, and Day 1 and 4 weeks after the last dose of study drug for patients who discontinued treatment early.|Safety analysis set|||Participants|||Count of Participants
2572800|NCT02501629|Secondary|Percentage of Participants Achieving an OCS Dose of 0 mg at Weeks 20-24 While Maintaining Asthma Control|"Percentage of participants who discontinue use of OCS during weeks 20-24 while maintaining asthma control.~Patients listed as no continued to use OCS during weeks 20-24, or who discontinued use of OCS during weeks 20-24 but lost control of their asthma, or discontinued from study drug."|Weeks 20-24|ITT Analysis set; missing data are included as non-responders (No).|||percentage of participants|||Number
2572801|NCT02501629|Secondary|Annualized Rate of Clinical Asthma Exacerbations (CAEs)|The annual exacerbation rate is based on clinical asthma exacerbations reported by the investigator in the eCRF.|Day 1 through Week 24|ITT Analysis Set|||CAEs / year||95% Confidence Interval|Number
2572802|NCT02501629|Secondary|Percentage of Participants Achieving a >=5 mg Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control|"Percentage of participants whose OCS dose at weeks 20-24 was reduced by at least 5mg from baseline and maintained asthma control. Patients listed as no had a week 20-24 OCS dose that did not meet the threshold of a 5mg reduction, or whose OCS dose met the threshold but did not maintain asthma control, or discontinued from study drug."|Baseline (Day 1), Weeks 20-24|ITT Analysis set; missing data are included as non-responders (No).|||percentage of participants|||Number
2572803|NCT02501629|Secondary|Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 Using a Mixed Model for Repeated Measures|"The baseline OCS dose is the prescribed optimized OCS dose following the OCS optimization period. Endpoint data are presented using an on-treatment approach. In this context, 'endpoint' was defined as the last observation obtained at a scheduled or qualified early termination visit during the treatment period. Weeks 20-24 data is included between the Week 20 dose and Week 24 for completed patients; last dose of study drug to 4 weeks after the last dose of study drug for patients who discontinued treatment early. Measurements collected outside of these defined timeframes are excluded from the analyses.~The mixed model repeated measures (MMRM) included fixed effects for treatment, visit, treatment by visit interaction, age group, and OCS dose group, duration of OCS use and baseline value as covariates, and patient as a random effect. Unstructured covariance was assumed for the repeated measures."|Baseline (Day 1), Weeks 20-24|ITT analysis population with available data using the on-treatment approach.|||percent change||Standard Error|Least Squares Mean
2572804|NCT02501629|Secondary|Percentage of Participants Achieving an OCS Dose of <=5 mg at Weeks 20-24 While Maintaining Asthma Control|"Percentage of participants whose OCS dose at weeks 20-24 was <=5 mg and they maintained asthma control.~Patients listed as no had a week 20-24 OCS dose > 5 mg, or whose OCS dose was <=5 mg at weeks 20-24 but did not maintain asthma control, or they discontinued from study drug."|Weeks 20-24|ITT Analysis set; missing data are included as non-responders (No).|||percentage of participants|||Number
2572805|NCT02501629|Secondary|Percentage of Participants Achieving a >=50% Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control|"Percentage of patients whose OCS dose at weeks 20-24 was reduced >=50% compared to baseline while maintaining asthma control.~Patients listed as no did not achieve the 50% reduction in baseline OCS dose goal, or did achieve that goal but lost asthma control during weeks 20 to 24, or discontinued from study drug."|Baseline (Day 1), Weeks 20-24|ITT Analysis set; missing data are included as non-responders (No).|||percentage of participants|||Number
2572806|NCT02501629|Primary|Number of Participants With Reduction In Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 As Compared to the Optimized Dose At Baseline|"The primary endpoint was the 5-level categorized percent reduction in OCS dose during weeks 20 to 24 compared with the optimized dose at baseline. The primary analysis incorporated data from all randomized patients. Analysis of the primary and secondary variables related to categorical OCS dose reduction incorporated missing data as non-responders.~No decrease indicates there was no decrease in OCS, loss of baseline asthma control during weeks 20 to 24, or discontinuation from study drug."|Baseline (Day 1), Weeks 20-24|Intent to Treat (ITT) Analysis set; missing data are included as non-responders (no decrease).|||Participants|||Count of Participants
2572807|NCT02501590|Primary|Normilized Muscle Activity|The maximal voluntary contraction (MVC) value for each muscle will be computed as the average of three peaks of the surface electromyography (sEMG) data, which differed by no more than 10% from one another. The mean root mean square (RMS) values of the sEMG data will be normalized by the MVC value for each muscle so that the value is presented by percentage.|day1||||% mvc||Inter-Quartile Range|Median
2572808|NCT02501161|Secondary|Change in TRIM-D|Treatment related impact measures-diabetes (TRIM-D) was developed according to the FDA guidance from 2009 on development of new PRO measures. The questionnaire consists of 5 sub-domains, which are scored according to a 1-5 point scale with a higher score indicating a better health state (less negative impact). Sub-domain scores are calculated by summing across items in the same sub-domain, and the total score is calculated by summing scores from all the sub-domains. The highest possible summed score within a sub-domain ranges from 20 (compliance sub-domain) to 40 (psychological health sub-domain) points and the highest possible total score is 140 points. Change in TRIM-D total score from baseline (week 0) to week 26 and week 104 is presented. A positive change score indicates an improvement since baseline.|Week 0, week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Score on a scale||Standard Deviation|Mean
2572809|NCT02501161|Secondary|Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS)|SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores and component summary (PCS and MCS) scores are presented. A positive change score indicates an improvement since baseline.|Week 0, week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Score on a scale||Standard Deviation|Mean
2573151|NCT02498821|Secondary|Total Number of Chest X-rays Performed Per Subject||Measured from initiation to completion of procedure (usually from 0 to 300 minutes)||||Chest X-rays||Full Range|Mean
2572814|NCT02501161|Secondary|Change in Haematological Parameter- Neutrophils|Change in neutrophils from baseline (week 0) to week 26 and week 104 is presented.|Week 0, week 26, week 104|SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.|||Percentage of neutrophils||Standard Deviation|Mean
2572815|NCT02501161|Secondary|Change in Haematological Parameter- Eosinophils|Change in eosinophils from baseline (week 0) to week 26 and week 104 is presented.|Week 0, week 26, week 104|SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.|||Percentage of eosinophils||Standard Deviation|Mean
2572816|NCT02501161|Secondary|Change in Haematological Parameter- Thrombocytes and Leukocytes|Change in thrombocytes and leukocytes from baseline (week 0) to week 26 and week 104 is presented.|Week 0, week 26, week 104|SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.|||10^9 cells/L||Standard Deviation|Mean
2572817|NCT02501161|Secondary|Change in Haematological Parameter- Erythrocytes|Change in erythrocytes from baseline (week 0) to week 26 and week 104 is presented.|Week 0, week 26, week 104|SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.|||10^12 cells/L||Standard Deviation|Mean
2572818|NCT02501161|Secondary|Change in Haematological Parameter- Haematocrit|Change in haematocrit from baseline (week 0) to week 26 and week 104 is presented.|Week 0, week 26, week 104|SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.|||Percentage of red blood cells||Standard Deviation|Mean
2572819|NCT02501161|Secondary|Change in Haematological Parameter- Haemoglobin|Change in haemoglobin from baseline (week 0) to week 26 and week 104 is presented.|Week 0, week 26, week 104|SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.|||g/dL||Standard Deviation|Mean
2572820|NCT02501161|Secondary|Change in Biochemistry Parameter- Sodium, Potassium and Calcium|Change in sodium, potassium and calcium from baseline (week 0) to week 26 and week 104 is presented.|Week 0, week 26, week 104|SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.|||mmol/L||Standard Deviation|Mean
2572821|NCT02501161|Secondary|Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase|Change in biochemistry parameters- alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lipase and amylase from baseline (week 0) to week 26 and week 104 is presented.|Week 0, week 26, week 104|SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.|||Units per liter (U/L)||Standard Deviation|Mean
2572822|NCT02501161|Secondary|Change in Biochemistry Parameter- Albumin|Change in biochemistry parameter- albumin from baseline (week 0) to week 26 and week 104 is presented.|Week 0, week 26, week 104|SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.|||Grams per deciliter (g/dL)||Standard Deviation|Mean
2572823|NCT02501161|Secondary|Change in Biochemistry Parameter- Creatinine, Total Bilirubin|Change in biochemistry parameter- creatinine, total bilirubin from baseline (week 0) to week 26 and week 104 is presented.|Week 0, week 26, week 104|SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.|||Micromoles per liter (umol/L)||Standard Deviation|Mean
2572824|NCT02501161|Secondary|Change in Pulse Rate|Change in pulse rate from baseline (week 0) to week 26 and week 104 is presented.|Week 0, week 26, week 104|SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.|||Beats per minute||Standard Deviation|Mean
2572825|NCT02501161|Secondary|Change in Urine Albumin/Creatinine Ratio|Change in urine albumin/creatinine ratio from baseline (week 0) to week 104 is presented.|Week 0, week 104|SAS included all participants receiving at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.|||Milligrams per millimole (mg/mmol)||Standard Deviation|Mean
2572826|NCT02501161|Secondary|ECG Evaluation|The electrocardiogram (ECG) was assessed at baseline (within 2 weeks prior to week 0) and week 104. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 104 are presented.|Baseline (within 2 weeks prior to week 0), week 104|SAS included all participants receiving at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.|||Participants|||Count of Participants
2572827|NCT02501161|Secondary|Eye Examination Category|Fundus photography or a dilated fundoscopy was performed at baseline (within 12 weeks prior to week 0) and week 104. The investigator interpreted each eye's (left and right) results and categorised them as: normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Number of participants in each category at baseline and week 104 were presented.|Baseline (within 12 weeks prior to week 0), week 104|SAS included all participants receiving at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data.|||Participants|||Count of Participants
2572828|NCT02501161|Secondary|Number of TEAEs During 104 Weeks of Treatment|An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 104 weeks of treatment is presented.|Week 0 to week 104|SAS included all participants receiving at least 1 dose of the investigational product or comparator.|||Adverse events|||Number
2572839|NCT02501161|Secondary|Change in Fasting HDL-cholesterol|Change in fasting high density lipoprotein (HDL)- cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.|Week 0, week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Ratio of HDL-cholesterol||Geometric Coefficient of Variation|Geometric Mean
2572829|NCT02501161|Secondary|Number of TEAEs During 26 Weeks of Treatment|An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A treatment emergent adverse event (TEAE) was defined as an adverse event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 26 weeks of treatment is presented.|Weeks 0-26|SAS included all participants receiving at least 1 dose of the investigational product or comparator.|||Adverse events|||Number
2572830|NCT02501161|Secondary|Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment|Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 104 weeks of treatment is presented.|Weeks 0-104|SAS included all participants receiving at least 1 dose of the investigational product or comparator.|||Episodes|||Number
2572831|NCT02501161|Secondary|Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment|Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment is presented.|Weeks 0-26|SAS included all participants receiving at least 1 dose of the investigational product or comparator.|||Episodes|||Number
2572832|NCT02501161|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment|Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment emergent hypoglycaemic episodes according to ADA during 104 weeks of treatment is presented.|Weeks 0-104|SAS included all participants receiving at least 1 dose of the investigational product or comparator.|||Episodes|||Number
2572833|NCT02501161|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment|Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent hypoglycaemic episodes according to ADA during 26 weeks of treatment is presented.|Weeks 0-26|SAS included all participants receiving at least 1 dose of the investigational product or comparator.|||Episodes|||Number
2572834|NCT02501161|Secondary|Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment|Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during 104 weeks of treatment is presented.|Weeks 0-104|SAS included all participants receiving at least 1 dose of the investigational product or comparator.|||Episodes|||Number
2572835|NCT02501161|Secondary|Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment|Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment is presented.|Weeks 0-26|SAS included all participants receiving at least 1 dose of the investigational product or comparator.|||Episodes|||Number
2572836|NCT02501161|Secondary|Change in Fasting Free Fatty Acids|Change in fasting free fatty acids (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.|Week 0, week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Ratio of free fatty acids||Geometric Coefficient of Variation|Geometric Mean
2572837|NCT02501161|Secondary|Change in Fasting Triglycerides|Change in fasting triglycerides (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.|Week 0, week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Ratio of triglycerides||Geometric Coefficient of Variation|Geometric Mean
2572838|NCT02501161|Secondary|Change in Fasting VLDL-cholesterol|Change in fasting very low density lipoprotein (VLDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.|Week 0, week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Ratio of VLDL-cholesterol||Geometric Coefficient of Variation|Geometric Mean
2572867|NCT02501135|Primary|Total mg of Local Anesthetic Injected for Femoral Nerve Block||length of surgery||||ml/kg||Inter-Quartile Range|Median
2572840|NCT02501161|Secondary|Change in Fasting LDL-cholesterol|Change in fasting low density lipoprotein (LDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.|Week 0, week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Ratio of LDL-cholesterol||Geometric Coefficient of Variation|Geometric Mean
2572841|NCT02501161|Secondary|Change in Fasting Total Cholesterol|Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.|Week 0, week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Ratio of total cholesterol||Geometric Coefficient of Variation|Geometric Mean
2572842|NCT02501161|Secondary|Change in Fasting Human Insulin|Change in fasting human insulin (measured in picomoles per liter [pmol/L]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.|Week 0, week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Ratio of insulin||Geometric Coefficient of Variation|Geometric Mean
2572843|NCT02501161|Secondary|Change in Fasting C-peptide|Change in fasting C-peptide (measured in nanomoles per liter [nmol/L]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.|Week 0, week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Ratio of C-peptide||Geometric Coefficient of Variation|Geometric Mean
2572844|NCT02501161|Secondary|Change in Blood Pressure (Systolic and Diastolic)|Change in blood pressure (systolic and diastolic) from baseline (week 0) to week 26 and week 104 is presented.|Week 0, week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2572845|NCT02501161|Secondary|Change in SMPG-mean Postprandial Increment Over All Meals|Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean postprandial increment over all meals from baseline (week 0) to week 26 and week 104 is presented.|Week 0, week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||mmol/L||Standard Deviation|Mean
2572846|NCT02501161|Secondary|Change in SMPG-mean 9-point Profile|Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean 9-point profile from baseline (week 0) to week 26 and week 104 is presented.|Week 0, week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||mmol/L||Standard Deviation|Mean
2572847|NCT02501161|Secondary|SMPG-9-point Profile (Individual Points in the Profile)|Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Self-measured plasma glucose (SMPG)-9-point profile (individual points in the profile) at week 26 and week 104 is presented.|Week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||mmol/L||Standard Deviation|Mean
2572848|NCT02501161|Secondary|Change in FPG|Change in fasting plasma glucose (FPG) from baseline (week 0) to week 26 and week 104 is presented.|Week 0, week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||mmol/L||Standard Deviation|Mean
2572849|NCT02501161|Secondary|Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain|Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented.|Week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Percentage of participants|||Number
2572850|NCT02501161|Secondary|Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes|Severe or BG confirmed symptomatic hypoglycaemia is defined as an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented.|Week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Percentage of participants|||Number
2572851|NCT02501161|Secondary|Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain|Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without weight gain at week 26 and week 104 is presented.|Week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Percentage of participants|||Number
2572852|NCT02501161|Secondary|Participants Who Achieved (Yes/no): HbA1c ≤6.5%|Percentage of participants who achieved (yes/no) HbA1c ≤6.5% at week 26 and week 104 is presented.|Week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Percentage of participants|||Number
2572868|NCT02501135|Primary|Concentration of Local Anesthetic Injected for Femoral Nerve Block||length of surgery||||Participants|||Count of Participants
2572905|NCT02500706|Secondary|Change From Baseline in Potassium 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for potassium measurement.|||mmol/L||Standard Deviation|Mean
2572853|NCT02501161|Secondary|Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain|Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented.|Week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Percentage of participants|||Number
2572854|NCT02501161|Secondary|Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes|Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented.|Week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Percentage of participants|||Number
2572855|NCT02501161|Secondary|Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain|Percentage of participants who achieved (yes/no) HbA1c <7.0% without weight gain at week 26 and week 104 is presented.|Week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Percentage of participants|||Number
2572856|NCT02501161|Secondary|Participants Who Achieved (Yes/no): HbA1c <7.0%|Percentage of participants who achieved (yes/no) HbA1c <7.0% at week 26 and week 104 is presented.|Week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Percentage of participants|||Number
2572857|NCT02501161|Secondary|Insulin Dose|Insulin dose after 26 and 104 weeks of treatment is presented.|Week 26, week 104|Safety analysis set (SAS) included all participants receiving at least 1 dose of the investigational product (IDegLira) or comparator (IGlar). 'Number analyzed'=participants with available data.|||Units||Standard Deviation|Mean
2572858|NCT02501161|Secondary|Change in Body Weight|Change in body weight from baseline (week 0) to week 26 and week 104 is presented.|Week 0, week 26, week 104|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Kilogram (kg)||Standard Deviation|Mean
2572859|NCT02501161|Secondary|Change in HbA1c|Change in HbA1c from baseline (week 0) to week 26 is presented.|Week 0, week 26|FAS included all randomised participants. 'Number analyzed'=participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2572860|NCT02501161|Secondary|Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits|"Time to HbA1c > 6.5% at 2 consecutive visits is defined as time from randomization to HbA1c > 6.5% at 2 consecutive planned scheduled visits from week 26 (including week 26 if HbA1c was > 6.5% at week 12). Time from randomisation to HbA1c >6.5% at 2 consecutive visits was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable baseline HbA1c group was a dichotomised baseline HbA1c variable with 2 categories: HbA1c < 8.5% or HbA1c ≥ 8.5% and the variable previous OAD treatment was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function."|Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2|FAS included all randomised participants. Number analyzed=participants with event.|||Weeks||Inter-Quartile Range|Median
2572861|NCT02501161|Primary|Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification|"Inadequate glycaemic control and need for treatment intensification was defined as a glycosylated haemoglobin (HbA1c) of 7.0% or greater at 2 consecutive visits from week 26, including week 26 if HbA1c was greater than or equal to 7% at week 12. Time from randomisation to inadequate glycaemic control and need for treatment intensification was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable baseline HbA1c group was a dichotomised baseline HbA1c variable with 2 categories: HbA1c < 8.5% or HbA1c ≥ 8.5% and the variable previous OAD treatment was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function."|Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2|FAS included all randomised participants. Number analyzed=participants in the specified category.|||Weeks||Inter-Quartile Range|Median
2572862|NCT02501135|Secondary|Post-operative Pain Scale Using VAS|"The visual analogue scale (VAS) for pain is a validated, subjective measure where scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain."|1 hour post-op|197 out of the total 281 subjects had their pain assessed using VAS.|||units on a scale||Inter-Quartile Range|Median
2572863|NCT02501135|Secondary|Post-operative Pain Scale Using FLACC|The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain.|1 hour post-op|63 of the 281 total subjects had their pain assessed using the FLACC pain scale.|||units on a scale||Inter-Quartile Range|Median
2572864|NCT02501135|Secondary|Time to Discharge From PACU||Conclusion of surgery until admission to assigned unit or to phase, an expected average of 1 hour|One patient was excluded from analysis of time to PACU discharge due to a missing PACU arrival time.|||minutes||Inter-Quartile Range|Median
2572865|NCT02501135|Primary|Post-operative Opioids Administered|Amount of opioid consumption in the post operative anesthesia care unit depending on if the patient received femoral nerve block with ropivacaine or bupivacaine|in PACU (1 hr post-op)||||mg/kg||Inter-Quartile Range|Median
2572866|NCT02501135|Primary|Intraoperative Tylenol Administered|Amount of Tylenol administered based on if got ropivacaine or bupivacaine femeral nerve block.|length of surgery||||percentage of participants|||Number
2572869|NCT02500979|Secondary|Pharmacokinetics of Insulin as Demonstrated by the Time to the Maximum Plasma Insulin Concentration|Mean time to maximum plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours [dinner], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours [breakfast], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours [lunch], 24 hours).|24 hours|Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.|||h||Standard Deviation|Mean
2572870|NCT02500979|Secondary|Pharmacokinetics of Insulin as Demonstrated by Maximum Plasma Insulin Concentration|Mean maximum plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours [dinner], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours [breakfast], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours [lunch], 24 hours).|24 hours|Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.|||mIU/L||Standard Deviation|Mean
2572871|NCT02500979|Secondary|Pharmacokinetics of Insulin as Demonstrated by 24-hour Average Plasma Insulin Concentration.|Mean values of the average plasma insulin concentrations over the 24-hour periods of pramlintide and placebo administration. (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours [dinner], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours [breakfast], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours [lunch], 24 hours).|24 hours|Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.|||mIU/L||Standard Deviation|Mean
2572872|NCT02500979|Secondary|Pharmacokinetics of Insulin as Demonstrated by 24-hour Plasma Insulin Area Under the Plasma Concentration-time Curve (AUC)|Mean areas under the plasma insulin concentration curves for the 24-hour periods of pramlintide and placebo administration (Sample times: -15 min, 0, 30 min, 1 hour 30 min, 2 hours [dinner], 2 hours 15 min, 2 hours 30 min, 2 hours 45 min, 3 hours, 4 hours, 5 hours, 6 hours, 9 hours, 12 hours, 15 hours, 16 hours [breakfast], 16 hours 15 min, 16 hours 30 min, 16 hours 45 min, 17 hours, 18 hours, 19 hours, 20 hours [lunch], 24 hours).|24 hours|Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.|||mU/L*h||Standard Deviation|Mean
2572873|NCT02500979|Secondary|Fasting Plasma Glucose Concentration|Fasting plasma glucose concentration at 0600 hours (6:00 AM)|12 hours after dinner meal|Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.|||mmol/L||95% Confidence Interval|Least Squares Mean
2572874|NCT02500979|Secondary|Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC)|Incremental (i.e., baseline-corrected) mean area under the 24-hour plasma glucagon concentration curve with a pre-test, non-fasting plasma glucagon value as baseline. (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours).|24 h|Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.|||pmol/L*h||Standard Deviation|Mean
2572875|NCT02500979|Secondary|Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucagon Area Under the Plasma Concentration-time Curve (AUC)|Absolute mean area under the 24-hour plasma glucagon concentration curve, measured as total area under the curve (total AUC0-24). (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours).|24 h|Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.|||h*pmol/L||95% Confidence Interval|Least Squares Mean
2572876|NCT02500979|Secondary|Efficacy of Pramlintide Measured by Percent Time Spent in the Range of >70 mg/dL to <180 mg/dL Tissue Glucose Obtained With Continuous Glucose Monitoring (CGM)|Percent time spent in the normoglycemic range of tissue glucose concentrations between >70 mg/dL and <180 mg/dL, measured by CGM. (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours).|24 h|Full Analysis Set:Of the 33 correctly randomized subjects, 26 (76.5%) had at least 1 efficacy assessment available from each of the 2 crossover periods and were included in the Full Analysis Set.|||Percentage of time||95% Confidence Interval|Least Squares Mean
2572877|NCT02500979|Secondary|Efficacy of Pramlintide by Measurement of Incremental 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC)|Incremental (i.e., baseline-corrected) mean area under the 24-hour plasma glucose concentration curve, measured as total area under the curve (0 to 24 hours). (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours).|24 hours|Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.|||mmol/L*h||Standard Deviation|Mean
2572903|NCT02500706|Secondary|Change From Baseline in Total Protein 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for total protein measurement.|||g/dL||Standard Deviation|Mean
2572878|NCT02500979|Secondary|Efficacy of Pramlintide by Measurement of Absolute 24-hour Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC)|Absolute mean area under the 24-hour plasma glucose concentration curve, measured as total area under the curve (0 to 24 hours). (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours).|24 h|Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.|||mmol/L*h||95% Confidence Interval|Least Squares Mean
2572879|NCT02500979|Secondary|Efficacy of Pramlintide by Measurement of Incremental 24-hour Tissue Glucose Area Under the Plasma Concentration-time Curve (AUC) Obtained With Continuous Glucose Monitoring (CGM)|Incremental (i.e., baseline-corrected) area under the 24-hour tissue glucose concentration curve (AUC0-24h) measured by continuous glucose monitoring (CGM) with a pre-test, non-fasting tissue glucose value as baseline. (Sample times: 0, 30 min, 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours, 9 hours, 12 hours, 14 hours, 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours, 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours).|24 h|Full Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) had at least 1 efficacy assessment available from each of the 2 crossover periods and were included in the Full Analysis Set,|||mg/dL*min||Standard Error|Least Squares Mean
2572880|NCT02500979|Secondary|Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Breakfast|Absolute postprandial plasma glucose AUC (AUC0-2h) was measured for the first 2 hours following breakfast based on sample availability. (Sample times: 16 hours [breakfast], 16 hours 45 min, 17 hours, 18 hours).|2 hours|Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.|||mmol/L*h||95% Confidence Interval|Least Squares Mean
2572881|NCT02500979|Secondary|Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Dinner|Absolute postprandial plasma glucose AUC (AUC0-2h) was measured for the first 2 hours following dinner based on sample availability. (Sample times: 2 hours [dinner], 2 hours 45 min, 3 hours, 4 hours).|2 hours|Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.|||mmol/L*h||95% Confidence Interval|Least Squares Mean
2572882|NCT02500979|Secondary|Efficacy of Pramlintide by Measurement of Absolute Plasma Glucose Area Under the Plasma Concentration-time Curve (AUC) Following Lunch|Absolute postprandial plasma glucose AUC was measured for the first 3 hours (AUC0-3h) following lunch based on sample availability. (Sample times: 20 hours [lunch], 20 hours 45 min, 21 hours, 23 hours, 24 hours).|3 hours|Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) subjects received at least 1 dose of pramlintide and had evaluable PD data and were, therefore, included in the PK/PD Analysis Set.|||mmol/L*h||95% Confidence Interval|Least Squares Mean
2572883|NCT02500979|Primary|Efficacy of Pramlintide by Measurement of 24-hour Tissue Mean Weighted Glucose (MWG) Obtained With Continuous Glucose Monitoring (CGM)|24-hour MWG mg/dL, defined as total area under the 24-hour tissue glucose curve obtained with CGM, divided by actual time span in the 24-hour period.|24 h|Full Analysis Set: Of the 33 correctly randomized subjects, 26 (76.5%) had at least 1 efficacy assessment available from each of the 2 crossover periods and were included in the Full Analysis Set.|||mg/dL||Standard Error|Least Squares Mean
2572884|NCT02500901|Secondary|Objective Response (OR) Rates for All Subjects With Confirmed Partial Response (PR) or Complete Response (CR) Outcomes, Per RECIST v1.1|OR outcomes for subjects on this combination therapy, per RECIST v1.1|From the date of enrollment until the date of documented disease progression or the date of death from any cause, whichever occurs first, assessed up to 52 weeks|Sufficient data was not collected or analyzed for this secondary objective before study termination.||||||
2572885|NCT02500901|Secondary|Progression-free Survival (PFS) With Enzalutamide and Niraparib Combination Therapy.|PFS per RECIST v1.1 for subjects on this combination therapy.|From the date of enrollment until the criteria for disease progression is met as defined by RECIST 1.1 or death from any cause, whichever occurs first, assessed up to 52 weeks|Sufficient data was not collected or analyzed for this secondary objective before study termination.||||||
2572886|NCT02500901|Primary|Maximum Tolerated Dose (MTD) for Subjects Receiving Enzalutamide With Niraparib Without Experiencing Dose-limiting Toxicity(s) (DLT)|MTD of niraparib in combination with enzalutamide and MTD for phase II testing.|From the start of combination treatment D29 until 30 days after last dose of study treatment per CTCAE v4, assessed up to 52 weeks|Sufficient data was not collected to determine the maximum tolerated dose (MTD) before study termination.||||||
2572887|NCT02500836|Secondary|Immediate and Sustained Anesthetic Success for Cocaine HCl 10% Topical Solution|Subjects who meet the following for each nostril that received the study drug application are considered a treatment success: Prior to the diagnostic procedure or surgery, based on the von Frey monofilament test, after application of the assigned study drug solution (Cocaine HCl 10% Topical Solution), the subject response is a 0 (zero) pain score on the 11 point pain scale (0 = no pain, 10 = unbearable pain) compared to the von Frey monofilament test right before study drug application. And, during the diagnostic procedure or surgery, no further analgesic treatment is required (only 10% Cocaine HCl subjects who receive a diagnostic procedure or surgery).|One Day, Single office based diagnostic procedure or surgery|The analysis of secondary outcome data is based on an intent-to-treat population, which includes all randomized subjects who received study drug. The analysis of this secondary efficacy endpoint includes comparisons to the primary endpoint for the Placebo Topical Solution treatment group.|||proportion of participants||95% Confidence Interval|Number
2572904|NCT02500706|Secondary|Change From Baseline in Creatinine 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for creatinine measurement.|||umol/L||Standard Deviation|Mean
2573152|NCT02498821|Primary|Time From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy).||Usually ranges from 0 to 300 minutes from initiation of procedure||||minutes||Standard Deviation|Mean
2572888|NCT02500836|Primary|Immediate and Sustained Anesthetic Success for Cocaine HCl 4% Topical Solution and Placebo Topical Solution|Subjects who meet the following for each nostril that received the study drug application are considered a treatment success: Prior to the diagnostic procedure or surgery, based on the von Frey monofilament test, after application of the assigned study drug solution (Cocaine HCl 4% Topical Solution or Placebo Topical Solution), the subject response is a 0 (zero) pain score on the 11 point pain scale (0 = no pain, 10 = unbearable pain) compared to the von Frey monofilament test right before study drug application. And, during the diagnostic procedure or surgery, no further analgesic treatment is required (only 4% Cocaine HCl subjects who receive a diagnostic procedure or surgery). Subjects with missing primary outcome data are marked as treatment failures in both treatment groups.|One Day, Single office based diagnostic procedure or surgery|The analysis of primary outcome data is based on an intent-to-treat population, which includes all randomized subjects who received study drug.|||proportion of participants||95% Confidence Interval|Number
2572889|NCT02500758|Secondary|"Change in the Release of Skin Flora From the Hands From Baseline to 3 Hours After Surgical Scrub Disinfection, Wearing Surgical Gloves (Time Frame- Baseline and 3 Hours)."|Number of colony-forming units (CFU) sampled 3 hours after disinfection by surgical scrubbing using parachlorometaxylenol or clorhexidine digluconate, using surgical gloves. After surgical scrubbing, drying and wearing surgical gloves, the fingertips are rubbed (including that of the thumb) for 1 minute on the base of a Petri dish containing volumes of 1.0 ml and 0.1 ml of undiluted sampling fluid of TSB and 0.1 ml from its 10-1 dilution are plated out for quantitative culture in TSA.|3 hours||||CFU/ml||95% Confidence Interval|Mean
2572890|NCT02500758|Primary|"Change in the Release of Skin Flora From the Hands From Baseline to 5 Minutes After Disinfection by Surgical Scrubbing (Time Frame- Baseline and 5 Minutes)."|Number of colony-forming units (CFU) sampled up to 5 minutes after disinfection by surgical scrubbing using parachlorometaxylenol or clorhexidine digluconate. After surgical scrubbing and drying, the fingertips are rubbed (including that of the thumb) for 1 minute on the base of a Petri dish containing volumes of 1.0 ml and 0.1 ml of undiluted sampling fluid of TSB and 0.1 ml from its 10-1 dilution are plated out for quantitative culture in TSA.|5 minutes||||CFU/ml||95% Confidence Interval|Mean
2572891|NCT02500732|Secondary|Systematic Vascular Resistance Index (From the Continuous BP Monitor) During Presyncope||From baseline to within 1 hour post start of head up tilt||||dynes*s/cm5*m2||Standard Deviation|Mean
2572892|NCT02500732|Secondary|Cardiac Index (From the Continuous BP Monitor) During Presyncope||From baseline to within 1 hour post start of head up tilt||||L/min/m2||Standard Deviation|Mean
2572893|NCT02500732|Secondary|Estimated Stroke Volume Index (From the Continuous BP Monitor) During Presyncope||From baseline to within 1 hour post start of head up tilt||||mL/m2||Standard Deviation|Mean
2572894|NCT02500732|Secondary|Number of Participants Who Become Presyncopal (Isolated) Associated With Diagnostic Criteria of Hypotension and Bradycardia||1 hour post start of head up tilt||||Participants|||Count of Participants
2572895|NCT02500732|Primary|Number of Participants Who Become Syncopal Associated With Diagnostic Criteria of Hypotension and Bradycardia||1 hour post start of head up tilt||||Participants|||Count of Participants
2572896|NCT02500706|Secondary|Change From Baseline in Body Mass Index 26 Weeks After Randomisation|The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number of subjects analysed=subject with data available for body mass index.|||kg/m^2||Standard Deviation|Mean
2572897|NCT02500706|Secondary|Change From Baseline in Body Weight 26 Weeks After Randomisation|The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number of subjects analysed=subject with data available for body weight.|||kg||Standard Deviation|Mean
2572898|NCT02500706|Secondary|Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation|Insulin aspart antibody titres (antibodies specific for insulin aspart and those cross-reacting with human insulin) measured at baseline and at 26 weeks. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period. Anti-insulin aspart antibody was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T).|Week 0, week 26|Analysis was based on the SAS. Number analysed=number of subjects with available data for anti-insulin aspart antibody.|||% B/T||Standard Deviation|Mean
2572899|NCT02500706|Secondary|Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation|Presence of erythrocytes in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with erythrocytes values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number analysed=number of subjects with available data for erythrocytes values.|||percentage of subjects|||Number
2572900|NCT02500706|Secondary|Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation|Presence of protein in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with protein values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number analysed=number of subjects with available data for protein values.|||percentage of subjects|||Number
2572901|NCT02500706|Secondary|Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation|Presence of ketone in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with ketone values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number analysed=number of subjects with available data for ketones values.|||percentage of subjects|||Number
2572902|NCT02500706|Secondary|Change From Baseline in Urinary Albumin-to-creatinine Ratio 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for urinary albumin and creatinine measurement.|||mg/mmol||Standard Deviation|Mean
2572906|NCT02500706|Secondary|Change From Baseline in Total Bilirubin 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for total bilirubin measurement.|||umol/L||Standard Deviation|Mean
2572907|NCT02500706|Secondary|Change From Baseline in Aspartate Aminotransferase 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for aspartate aminotransferase measurement.|||U/L||Standard Deviation|Mean
2572908|NCT02500706|Secondary|Change From Baseline in Alkaline Phosphatase 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for alkaline phosphatase measurement.|||U/L||Standard Deviation|Mean
2572909|NCT02500706|Secondary|Change From Baseline in Albumin 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for albumin measurement.|||g/dL||Standard Deviation|Mean
2572910|NCT02500706|Secondary|Change From Baseline in Alanine Aminotransferase 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for alanine aminotransferase measurement.|||U/L||Standard Deviation|Mean
2572911|NCT02500706|Secondary|Change From Baseline in Thrombocytes 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for thrombocytes measurement.|||Number of thrombocytes 10^9/L||Standard Deviation|Mean
2572912|NCT02500706|Secondary|Change From Baseline in Leukocytes 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for leukocytes measurement.|||Number of leukocytes 10^9/L||Standard Deviation|Mean
2572913|NCT02500706|Secondary|Change From Baseline in Haemoglobin 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for haemoglobin measurement.|||mmol/L||Standard Deviation|Mean
2572914|NCT02500706|Secondary|Change From Baseline in Haematocrit 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for haematocrit measurement.|||percentage of red blood cells in blood||Standard Deviation|Mean
2572915|NCT02500706|Secondary|Change From Baseline in Erythrocytes 26 Weeks After Randomisation|Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for erythrocytes measurement.|||number of erythrocytes 10^12/L||Standard Deviation|Mean
2572916|NCT02500706|Secondary|Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation|The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number analysed=number of subjects with available data for fundoscopy/fundus photography at specified timepoints.|||percentage of subjects|||Number
2572917|NCT02500706|Secondary|Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation|The electrocardiogram was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number analysed=number of subjects with available data for electrocardiogram at specified timepoints.|||percentage of subjects|||Number
2572918|NCT02500706|Secondary|Change From Baseline in Pulse 26 Weeks After Randomisation|Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number of subjects analysed=subjects with available data for pulse.|||beats/minute||Standard Deviation|Mean
2572919|NCT02500706|Secondary|Change From Baseline in Blood Pressure 26 Weeks After Randomisation|Change from baseline in systolic blood pressure and diastolic blood pressure 26 weeks after randomisation. Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number of subjects analysed=subjects with available data for blood pressure|||mmHg||Standard Deviation|Mean
2572947|NCT02500628|Primary|Heart Rate Variability (Frequency Domain)|total power in the frequency domain is estimated for 10 minutes prior to metformin ingestion and then divided by the total power in the frequency domain estimated for 10 minutes 2 hours after metformin ingestion. Ratio is log-transformed.|difference pre/post metformin ingestion (2 hours)|patients with or without fibromyalgia. with or without antipsychotic use|||ratio||Standard Deviation|Mean
2572964|NCT02500368|Secondary|Ease of Lens Removal|Subjective ratings scale (0-100): 0=Could not remove lens from eye, 20=Frequently takes multiple attempts to remove from eye; often unsuccessful, 40=Frequently takes multiple attempts to remove from eye, 60=Occasionally takes a few attempts to remove from eye, 80=Rarely difficult to remove from eye, 100=Always easy to remove lens from eye.|1 week||||units on a scale||Standard Deviation|Mean
2572920|NCT02500706|Secondary|Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination)|The physical examination parameters included head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; and skin. The examinations were measured as 'normal', 'abnormal, not clinically significant' (Abn, NCS) or 'abnormal, clinically significant' (Abn, CS). Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 results are based on the last on-treatment value (last value), which included the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on SAS. Number analysed=number of subjects with available data for physical examinations at specified timepoints.|||percentage of subjects|||Number
2572921|NCT02500706|Secondary|Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal|"ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia.~NN Classification:~Severe: same as per ADA classification~Symptomatic BG confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia~Asymptomatic BG confirmed: PG<3.1 mmol/L without symptoms consistent with hypoglycaemia~Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/Lwith symptoms consistent with hypoglycaemia~BG confirmed: PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia~Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia~Unclassifiable Results represent total number of hypoglycaemic episodes related to meals."|Week 0 to week 26 (+1 day)|Analysis was based on SAS.|||hypoglycaemic episodes|||Number
2572922|NCT02500706|Secondary|Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)|"ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia.~NN Classification:~Severe: same as per ADA classification~Symptomatic BG confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia~Asymptomatic BG confirmed: PG<3.1 mmol/L without symptoms consistent with hypoglycaemia~Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/Lwith symptoms consistent with hypoglycaemia~BG confirmed: PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia~Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia~Unclassifiable Results represent total number of hypoglycaemic episodes. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05:59 both inclusive."|Week 0 to week 26 (+1 day)|Analysis was based on SAS.|||hypoglycaemic episodes|||Number
2572923|NCT02500706|Secondary|Number of Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition During 26 Weeks After Randomisation: Overall|"ADA classification includes following criteria: Severe,Documented symptomatic,Asymptomatic,Probable symptomatic,Pseudo-hypoglycaemia.~NN Classification:~Severe:same as per ADA classification~Symptomatic blood glucose (BG) confirmed: PG<3.1 mmol/L with symptoms consistent with hypoglycaemia~Asymptomatic BG confirmed:PG<3.1 mmol/L without symptoms consistent with hypoglycaemia~Severe or BG confirmed symptomatic:severe according to ADA classification or BG confirmed by PG<3.1 mmol/L with symptoms consistent with hypoglycaemia~BG confirmed:PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia~Severe or BG confirmed:severe according to ADA classification or BG confirmed by PG<3.1 mmol/L with or without symptoms consistent with hypoglycaemia~Unclassifiable Results represent total number of hypoglycaemic episodes. Treatment emergent episode: an event that has onset up to 1 day after last day of randomised treatment and excluding events occurring in run-in period."|Week 0 to week 26 (+1 day)|Analysis was based on SAS.|||hypoglycaemic episodes|||Number
2572924|NCT02500706|Secondary|Number of Treatment-emergent Injection Site Reactions During the 26 Weeks After Randomisation|A treatment emergent event was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.|Week 0 to week 26 (+7 days)|Analysis was based on SAS.|||Injection site reactions|||Number
2572925|NCT02500706|Secondary|Number of Treatment Emergent Adverse Events During 26 Weeks After Randomisation|A treatment emergent adverse event (TEAE) was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of randomised treatment.|Week 0 to week 26 (+7 days)|Analysis was based on SAS.|||events|||Number
2572926|NCT02500706|Secondary|Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose)|The insulin doses were summarised descriptively at week 0 and week 26 both by meal type and as total daily dose (total daily and separately for each mealtime dose). Week 26 results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.|Week 0, week 26|Analysis was based on safety analysis set (all subjects receiving at least one dose of the investigational product or its comparator). Number of subjects analysed=subjects with available data for specified categories.|||Units||Standard Deviation|Mean
2572927|NCT02500706|Secondary|Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol)|Change from baseline in HDL cholesterol, LDL cholesterol and total cholesterol 26 weeks after randomization are represented as ratio to baseline values. The results are based on the last in-trial value (the last available measurement in the in-trial period).|Week 0, week 26|Analysis was based on FAS. Number analysed=number of subjects with available data for individual lipid parameter.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2572948|NCT02500628|Primary|Heart Rate Variability (Time Domain)|ratio of the standard deviation of sampled intervals between each heart beat for ten minutes at time 1 (prior to metformin ingestion) over standard deviation of the sampled intervals between each heart beat for ten minutes at time 2 (2 hours post metformin ingestion)|difference pre/post metformin ingestion (2 hours)|Patients with or without fibromyalgia, with or without antipsychotic use.|||msec/msec||Standard Deviation|Mean
2572949|NCT02500537|Secondary|Incidence of Repeat Hospital Admissions for Procedural-related Complications|Incidence of repeat hospital admissions for procedural-related complications for up to 30 days following procedure|30 Days following procedure||||participants|||Number
2572928|NCT02500706|Secondary|Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia|The percentage of subjects who achieved overall mean 1 hour PPG ≤7.8 mmol/L [140 mg/dL], had HbA1c < 7.0% and had minimal weight gain (increase in body weight from baseline <3.0%) 26 weeks after randomisation, and without severe hypoglycaemic episodes. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG or an HbA1c value or a body weight at week 26 were treated as non-responders.|26 weeks after randomisation|Analysis was based on FAS.|||percentage of subjects|||Number
2572929|NCT02500706|Secondary|Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia|Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L [140 mg/dL] 26 weeks after randomisation without severe hypoglycaemia. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.|26 weeks after randomisation|Analysis was based on FAS.|||percentage of subjects|||Number
2572930|NCT02500706|Secondary|Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L|Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L [140 mg/dL] 26 weeks after randomisation. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.|26 weeks after randomisation|Analysis was based on FAS.|||percentage of subjects|||Number
2572931|NCT02500706|Secondary|Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements|The subject was instructed to perform 7-9-7 SMPG point profile on 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast,60 minutes after the start of breakfast,before lunch,60 minutes after the start of lunch, before main evening meal,60 minutes after the start of main evening meal,and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on following day. Change from baseline in nocturnal PG values (nocturnal increments) was assessed by considering differences between PG values available at bedtime, at 4 a.m and the before breakfast value the following day: (04:00 PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 04:00 PG value). Results are based on the last in-trial value (the last available measurement in the in-trial period).|Week 0, week 26|Analysis was based on FAS. Number of analysed=subjects with available data for nocturnal SMPG measurements.|||mmol/L||Standard Deviation|Mean
2572932|NCT02500706|Secondary|Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile|The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Fluctuation in SMPG profile was the average absolute difference from the mean of the SMPG profile. Change from baseline is represented as ratio to baseline value. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 26|Analysis was based on FAS. Number of analysed=subjects who contributed to this analysis.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2572933|NCT02500706|Secondary|Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal)|The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. PPG increment for each meal (breakfast, lunch, main evening meal) was derived from the 7-point and 9-point profile as the difference between PPG values and the PG value before the meal in each separate profile. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 26|Analysis was based on FAS. Number of analysed=subject with data available data for PPG values and the PG value before the meal (breakfast, lunch, main evening meal).|||mmol/L||Standard Deviation|Mean
2572934|NCT02500706|Secondary|Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal)|The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Results were derived from the three profiles: post-breakfast, post-lunch, post-main evening meal. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 26|Analysis was based on FAS. Number of analysed=subject with data available data at three profiles: post-breakfast, post-lunch, post-main evening meal.|||mmol/L||Standard Deviation|Mean
2572950|NCT02500537|Secondary|Staple Line Assessment:|Number of additional intervention(s) to treat staple-line failure|Participants will be followed for the duration of hospital stay, on average up to 5 days post-op||||participants|||Number
2572935|NCT02500706|Secondary|Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile|The subject was instructed to perform a 7-9-7 SMPG point profile on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. The mean of the 7-9-7-point profile was defined as the area under the curve profile divided by the measurement time, and was calculated using the linear trapezoidal technique. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 26|Analysis was based on FAS. Number of analysed=subject with data available for 7-9-7 point profile.|||mmol/L||Standard Deviation|Mean
2572936|NCT02500706|Secondary|Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation|Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The corresponding PPG increments were derived separately using each PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 26|Analysis was based on FAS. Number of analysed=subject with data available for PPG and pre-prandial PG at individual timepoints.|||mmol/L||Standard Deviation|Mean
2572937|NCT02500706|Secondary|Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation|Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 26|Analysis was based on FAS. Number of analysed=subject with data available for PPG at individual timepoints.|||mmol/L||Standard Deviation|Mean
2572938|NCT02500706|Secondary|Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation|The percentage of subjects who achieved the HbA1c target of <7.0% without severe hypoglycaemia and with minimal weight gain (defined as less than a 3% increase) 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 or without body weight measurement at week 26 were treated as non-responders.|26 weeks after randomisation|Analysis was based on FAS.|||percentage of subjects|||Number
2572939|NCT02500706|Secondary|Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation|The percentage of subjects who achieved the HbA1c target of <7.0% without severe hypoglycaemia 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 were treated as non-responders.|26 weeks after randomisation|Analysis was based on FAS.|||percentage of subjects|||Number
2572940|NCT02500706|Secondary|Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation|The percentage of subjects who achieved the HbA1c target of <7.0% 26 weeks after randomisation. Subjects without an HbA1c measurement at week 26 were treated as non-responders.|26 weeks after randomisation|Analysis was based on FAS.|||percentage of subjects|||Number
2572941|NCT02500706|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation|The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 26|Analysis was based on FAS. Number of subjects analysed=subject with data available for HbA1c.|||mmol/L||Standard Deviation|Mean
2572942|NCT02500706|Secondary|Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation|The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 26|Analysis was based on FAS. Number of subjects analysed=subject with data available for 1,5-anhydroglucitol.|||ug/mL||Standard Deviation|Mean
2572943|NCT02500706|Secondary|Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test)|The 1-hour PPG increment was analysed based on the laboratory-measured values in the meal test, and was derived using the 1-hour PPG measurement minus the pre-prandial plasma glucose (PG). The results are based on the last in-trial value, which included the last available measurement in the in-trial period.|Week 0, week 26|Analysis was based on FAS. Number of subjects analysed=subject with data available for 1-hour PPG and pre-prandial PG.|||mmol/L||Standard Deviation|Mean
2572944|NCT02500706|Primary|Change From Baseline in HbA1c 26 Weeks After Randomisation|Change from baseline (week 0) in HbA1c was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.|Week 0, week 26|Analysis was based on FAS. Number of subjects analysed=subject with data available for HbA1c.|||percentage of HbA1c||Standard Deviation|Mean
2572945|NCT02500641|Primary|Pulse Wave Velocity|Comparison of the effects of Febuxostat and Allopurinol on Pulse Wave Velocity (PWV) after 36 weeks of treatment.|36 weeks of treatment|All randomized subjects who had taken at least one dose of study drug specified by treatment group and performed at least one primary efficacy assessment (PWV) after randomization.|||m/s||Standard Deviation|Mean
2572946|NCT02500628|Secondary|Number of Patients Reporting Side Effects From the Medication|Patient after testing generated an unprompted list of observed side effects from the medication. Many reported none. Results were scored as the binary presence or absence of side effect|2 hours after ingestion||||Participants|||Count of Participants
2572951|NCT02500537|Secondary|Staple Line Assessment: Incidence of Post-operative Infection|Incidence of post-operative infection at the staple line in abdominal patients and thoracic patients|Participants will be followed for the duration of hospital stay, on average up to 5 days||||participants|||Number
2572965|NCT02500368|Secondary|Ease of Lens Insertion|Subjective ratings scale (0-100): 0=Could not place lens on eye, 20=Frequently takes multiple attempts to place on eye; often unsuccessful, 40=Frequently takes multiple attempts to place on eye, 60=Occasionally takes a few attempts to place on eye, 80=Rarely difficult to place on eye, 100=Always easy to place lens on eye|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2572966|NCT02500368|Secondary|Visual Quality|Subjective ratings scale (0-100): 0=Extremely poor vision all of the time; cannot function, 20=Frequently annoying vision problems, 40=Occasionally annoying vision problems, 60=Occasionally noticeable but not annoying vision problems, 80=Rarely noticeable vision problems, 100=Excellent vision all of the time. Different time points were taken for vision quality: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2572967|NCT02500368|Secondary|Lens Tightness|Lens tightness Scale 0%-100%, 0%=extremely loose fit, 50%=optimal push resistance and smooth return, 100%=no movement.|Baseline and 1 week||||percentage of tightness||Standard Deviation|Mean
2572968|NCT02500368|Secondary|Post-blink Movement|Post-blink movement evaluated by estimating the distance the lens was moving immediately after a blink. Primary Gaze: (mm, 0.1 steps)|Baseline and 1 week||||mm steps||Standard Deviation|Mean
2572969|NCT02500368|Secondary|Lens Centration|"Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.~(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior"|1 week||||eyes|Eyes||Number
2572970|NCT02500368|Secondary|Lens Centration|"Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered.~(mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior"|Baseline||||eyes|Eyes||Number
2572971|NCT02500368|Secondary|Lens Problems|Lenses were evaluated for defects, scratches, fibers, blue specks, and other findings.|Baseline and 1 week||||Lenses|Lenses||Number
2572972|NCT02500368|Secondary|Lens Deposition|Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2572973|NCT02500368|Secondary|High Contrast Acuity at High Room Illumination|Logarithm of the Minimum Angle or Resolution (LogMAR) Chart|Baseline and 1 week||||LogMAR||Standard Deviation|Mean
2572974|NCT02500368|Secondary|Surface Appearance|Grade ratings category (smooth, grainy, or other)|1 week||||Eyes|Eyes||Number
2572975|NCT02500368|Secondary|Surface Appearance|Grade ratings category (smooth, grainy, or other)|Baseline||||Eyes|Eyes||Number
2572976|NCT02500368|Secondary|Lens Wettability|Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced.|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2572977|NCT02500368|Primary|Dryness|Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2572978|NCT02500368|Primary|Comfort|Subjective ratings scale (0-100) assessed: 0=Cannot be worn, causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2572979|NCT02500056|Secondary|Foreign Body Feeling|The question about foreign body feeling was a yes-or-no question|6-month follow-up|Drop-outs at 6-month follow-up (3+6) not included|||percentage of patients with foreign body|||Number
2572980|NCT02500056|Secondary|Chronic Pain|On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise|3-year follow-up||||percentage of patients with pain|||Number
2572981|NCT02500056|Primary|Chronic Pain|On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise|6-month follow-up||||percentage of patients with pain|||Number
2572982|NCT02499952|Secondary|Disease Assessment for Duration of Disease Response|Duration of disease response|From the start of treatment D1 every 6 weeks for initial 18 weeks, assessed for up to 52 weeks|Data for this secondary outcome measure was not collected or analyzed due to the early termination of this study.||||||
2572983|NCT02499952|Secondary|Disease Assessment for Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Criteria|ORR of single agent pembrolizumab in subjects with refractory GCTs, determined by sum of complete responses and partial responses for at least 3 months using RECIST 1.1 criteria|From the start of treatment D1 every 6 weeks for initial 18 weeks, assessed for up to 52 weeks|Data for this secondary outcome measure was not collected or analyzed due to the early termination of this study.||||||
2572984|NCT02499952|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability Using Common Terminology Criteria for Adverse Events (CTCAE) V4.|Toxicity and tolerability of pembrolizumab in subjects with refractory GCTs. All grade 3 and higher adverse events are reported.|Every week while patient is receiving pembrolizumab, assessed for up to 52 weeks||||Participants|||Count of Participants
2572985|NCT02499952|Primary|Clinical Benefit Rate (CBR)|"CBR of single agent pembrolizumab in subjects with refractory germ cell tumors (GCTs), determined by sum of complete responses, partial responses, and stable disease for at least 3 months using Immune Related Response Criteria (irRC).~Complete Response(irPR): Disappearance of all lesions in two consecutive observations not less than 4 wk apart.~Partial Response (irPR): decrease in tumor burden ≥50 %relative to baseline confirmed by a consecutive assessment at least 4 wk after first documentation.~Stable Disease (irSD): not meeting criteria for irCR or irPR, in absence of irPD."|up to 18 weeks||||percentage of participants w/ clinical b|||Number
2573026|NCT02499692|Primary|Technical Success Rate|Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician|1 day||||percentage of participants|||Number
2572986|NCT02499900|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs) During Both the Core Period and Extension Periods|An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date. The investigator determined relation to study drug. A severe AE is defined as an inability to carry out usual activities. A serious AE (SAE) is defined by federal regulation as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Although a subject may have had 2 or more adverse experiences the subject is counted only once in a category. The same subject may appear in different categories.|Core: Day 1 to Month 6 Extension: Month 7 to Month 12|Safety population|||Participants|||Count of Participants
2572987|NCT02499900|Secondary|Change From Baseline in the Beck Depression Inventory II (BDI-II) Total Score to Month 6 Using a Repeated Measures ANCOVA|Depressive symptoms were measured by the BDI-II, a 21-item, self-reported rating inventory that measures characteristic attitudes and symptoms of depression. The BDI-II assesses mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, suicidal ideas, sadness, crying, irritability, social withdrawal, body image, work difficulties, insomnia, fatigue, appetite, weight loss, bodily preoccupation, and loss of libido. Each of the 21 items is rated on a 4-point scale ranging from 0 to 3. BDI-II Total Score indicates the severity of depression and has a total range of 0 to 63. For those clinically diagnosed, scores from 0-13 represent minimal depressive symptoms, scores of 14-19 indicate mild depression, scores of 20-28 indicate moderate depression, and scores of 30-63 indicate severe depression. Negative change from baseline scores indicate improvement.|Baseline (Month 0), Months 1, 3 and 6|Full analysis set.|||units on a scale||Standard Error|Least Squares Mean
2572988|NCT02499900|Secondary|Change From Baseline in the Mental Health Index (MHI) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA|The MHI consists of 18 items and provides an assessment of 4 subscales of mental health, including Anxiety (5 items), Depression (4 items), Behavioral control (4 items), and Positive Affect (4 items), and 1 Total Score. The subscales and Total Score for analyses range from 0 to 100, with 0 indicating not mentally healthy and 100 indicating superior mental health. Positive change from baseline scores indicate improved mental health. Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction. If a participant skipped x items of y items, the scale was not computed: - MHI Total Score - 9 of 19 - Anxiety subscale - 2 of 5 - Depression subscale - 2 of 4 - Behavioral Control subscale - 2 of 4 - MHI Positive Affect subscale - 2 of 4|Baseline (Month 0), Months 1, 3 and 6|Full analysis set.|||units on a scale||Standard Error|Least Squares Mean
2572989|NCT02499900|Secondary|Change From Baseline in the Modified Fatigue Impact Scale (MFIS) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA|MFIS is a modified form of the Fatigue Impact Scale based on items derived from interviews with MS patients concerning how fatigue impacts their lives. It is a structured, self-report questionnaire consisting of 21 items assessing the effects of fatigue. All 21 items are scaled 0 to 4, with higher scores indicating a greater impact of fatigue on patient's activities. The Total MFIS score ranges from 0 to 84, the Physical Subscale from 0 to 36, the Cognitive Subscale from 0 to 40, and the Psychosocial Subscale from 0 to 8. A score of 0 indicates fatigue has no impact on activities and the high-end score indicates fatigue has extreme impact on activities. Negative change from baseline values indicate improvement in the effects of fatigue. Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from|Baseline (Month 0), Months 1, 3 and 6|Full analysis set (FAS). The participant was considered invalid if any of the items were missing.|||units on a scale||Standard Error|Least Squares Mean
2572990|NCT02499900|Secondary|Change From Baseline in the Treatment Satisfaction Questionnaire for Medication 9-item Version (TSQM-9) Convenience Score to Month 6 Using a Repeated Measures ANCOVA|Convenience perception was measured by the 3 convenience items (items 4 to 6) within the validated TSQM-9. The responses to each of the 3 convenience items are reported on a 1-to-7 scale. The TSQM-9 convenience scale is computed, for each subject, by adding the 3 items loading on each response with the lowest possible total score (1*3 on the 3 items) subtracted from this composite score, and divided by the greatest possible score (3*7) minus the lowest possible score (3), i.e., 21-3=18. This provides a transformed score between 0 and 1 that was multiplied by 100. The final scale is 0 (Extremely Difficult/Inconvenient) to 100 (Extremely Easy/Convenient). If more than one item is missing, then the convenience scale was considered invalid for that patient. Estimates and p-value are obtained from baseline-adjusted repeated measures ANCOVA with treatment, visit, and Country/Geographical Region as main factors, visit by treatment as the interaction term, and baseline score as the covariate.|Baseline (Month 0), Months 1, 3 and 6|Full analysis set (FAS) included those patients in the intent to treat (ITT) analysis set who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. Treatment naïve patients do not have TSQM-9 convenience scores at baseline and therefore are not included.|||units on a scale||Standard Error|Least Squares Mean
2572991|NCT02499900|Primary|Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) to Month 6 Using a Repeated Measures ANCOVA|"Patient satisfaction with the study medication was assessed using the MSQ a 1-item global patient-rated scale. Patients were asked to respond on a 7-point scale, ranging from extremely dissatisfied (1) to extremely satisfied (7), to the following: Overall, how satisfied are you with your current medication?. Positive change from baseline score indicates greater satisfaction with the medication. Estimates and p-value are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: MSQ=baseline MSQ score+treatment+visit+treatment by visit interaction."|Baseline (Month 0), Months 1, 3 and 6|Full analysis set (FAS) included those patients in the intent to treat (ITT) analysis set who received at least 1 dose of study drug and had at least 1 post-baseline efficacy assessment. Treatment naïve patients do not have a MSQ score at baseline so are not included.|||units on a scale||Standard Error|Least Squares Mean
2573027|NCT02499575|Secondary|Pain Relief Measured by Defense and Veterans Pain Scale|Evaluate patient-reported pain scores (scale of 0 (no pain) - 10 (worst pain)) at 0, 6, 12, 24, 36, 48, 60, and 72 hours following surgery|Through 72 hours post-surgery (0, 6, 12, 24, 36, 48, 60, and 72 hours post-surgery)||||units on scale of 0 -10|||Number
2572992|NCT02499887|Primary|Percentage of Subjects With a Return Visit to the ED Within 30 Days of ED Discharge|Subjects' medical records will be reviewed for the 30 day period following ED discharge to determine if they return to the treating ED or another regional ED for treatment of an acute asthma/COPD exacerbation. Regional ED records will be queried by use of data maintained by HEALTHeLINK, our regional health information organization system. This will allow for more complete capture of ED return visits that could be obtained by looking only at a single ED.|30 days|Study was discontinued due to low enrollment. No 30 day return visit data was collected.||||||
2572993|NCT02499783|Secondary|Change From Baseline in Fecal Calprotectin Level Over Time (Any Adalimumab Set)|The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.|Baseline (Week 0 of adalimumab), Weeks 4, 8, 26|Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Observed cases.|||μg/g||Standard Deviation|Mean
2572994|NCT02499783|Secondary|Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set)|The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)|Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 12, 16 20, 26|Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Observed cases.|||mg/L||Standard Deviation|Mean
2572995|NCT02499783|Secondary|Change From Baseline in Hs-CRP Level Over Double-Blind Weeks 0-4|The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.|Baseline, Weeks 2, 4|ITT Set: all participants who were randomized. Observed cases.|||mg/L||Standard Deviation|Mean
2572996|NCT02499783|Secondary|Change From Baseline in CDAI Over Time (Any Adalimumab Set)|"CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.~The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)"|Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26|Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Observed cases.|||units on a scale||Standard Deviation|Mean
2572997|NCT02499783|Secondary|Change From Baseline in CDAI Over Double-Blind Weeks 0-4|"CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.~The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment."|Baseline, Weeks 2, 4|ITT Set: all participants who were randomized. Observed cases.|||units on a scale||Standard Deviation|Mean
2572998|NCT02499783|Secondary|Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set)|"CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.~The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)"|Weeks 2, 4, 6, 8, 12, 16, 20, 26|Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Non-responder imputation.|||percentage of participants|||Number
2572999|NCT02499783|Secondary|Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Double-Blind Weeks 0-4|"CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.~The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment."|Weeks 2, 4|ITT Set: all participants who were randomized. Non-responder imputation.|||percentage of participants|||Number
2573019|NCT02499783|Secondary|Percentage of Participants Who Achieved Clinical Remission at Week 26 (CDAI < 150) in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8|CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.|Week 26|All participants who were randomized and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 8. Non-responder imputation.|||percentage of participants|||Number
2573028|NCT02499575|Primary|Total Opioid Use as Measured by Questionnaire|Compare total opioid use (reported as total morphine equivalents) over 72 hours between groups.|Daily through the third day (72 hours) post-surgery||||morphine equivalents|||Number
2573000|NCT02499783|Secondary|Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set)|"CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.~The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)"|Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26|Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Non-responder imputation.|||percentage of participants|||Number
2573001|NCT02499783|Secondary|Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Double-Blind Weeks 0-4|"CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.~The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment."|Weeks 2, 4|ITT Set: all participants who were randomized. Non-responder imputation.|||percentage of participants|||Number
2573002|NCT02499783|Secondary|Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set)|"CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.~The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)"|Weeks 2, 4, 6, 8, 12, 16, 20, 26|Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Non-responder imputation.|||percentage of participants|||Number
2573003|NCT02499783|Secondary|Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus A Reduction in Hs-CRP of at Least 50% From Baseline Over Double-Blind Weeks 0-4|"CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.~The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment."|Weeks 2, 4|ITT Set: all participants who were randomized. Non-responder imputation.|||percentage of participants|||Number
2573004|NCT02499783|Secondary|Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set)|"CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.~The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)"|Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26|Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Non-responder imputation.|||percentage of participants|||Number
2573005|NCT02499783|Secondary|Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Double-Blind Weeks 0-4|"CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.~The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment."|Weeks 2, 4|ITT Set: all participants who were randomized. Non-responder imputation.|||percentage of participants|||Number
2573006|NCT02499783|Secondary|Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 26 in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8|CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.|Week 26|All participants who were randomized and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 8. Non-responder imputation.|||percentage of participants|||Number
2573007|NCT02499783|Secondary|Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 4|CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.|Week 4|ITT Set: all participants who were randomized. Non-responder imputation.|||percentage of participants|||Number
2573008|NCT02499783|Secondary|Change From Baseline in Fecal Calprotectin Level at Week 4||Baseline, Week 4|ITT Set: all participants who were randomized. Observed cases.|||μg/g||Standard Deviation|Mean
2573029|NCT02499575|Primary|Opioid Use as Measured by Questionnaire|Compare time to first opioid use over 72 hours between groups|Daily through the third day (72 hours) post-surgery||||hours|||Number
2573009|NCT02499783|Secondary|Percentage of Participants Who Achieved IBDQ Remission (IBDQ ≥ 170 Points) at Week 26 in Participants With Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8|"The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of the responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life.~CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450."|Week 26|All participants who were randomized and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 8. Non-responder imputation.|||percentage of participants|||Number
2573010|NCT02499783|Secondary|Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170 Points) at Week 4|The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of the responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life.|Week 4|ITT Set: all participants who were randomized. Non-responder imputation.|||percentage of participants|||Number
2573011|NCT02499783|Secondary|Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L at Week 26 in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8|CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.|Week 26|All participants who were randomized and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 8. Non-responder imputation.|||percentage of participants|||Number
2573012|NCT02499783|Secondary|Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) and Hs-CRP < 3 mg/L at Week 4|CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.|Week 4|ITT Set: all participants who were randomized. Non-responder imputation.|||percentage of participants|||Number
2573013|NCT02499783|Secondary|Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 4|CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.|Week 4|ITT Set: all participants who were randomized. Non-responder imputation.|||percentage of participants|||Number
2573014|NCT02499783|Secondary|Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4|CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.|Week 4|ITT Set: all participants who were randomized. Non-responder imputation.|||percentage of participants|||Number
2573015|NCT02499783|Secondary|Percentage of Participants Who Discontinued Corticosteroid Use and Achieved CDAI < 150 Plus a Reduction in Hs-CRP of ≥ 50% From Baseline (BL) at Week 26 in Participants Taking Steroids at BL and Who Achieved CDAI Decrease and Hs-CRP Reduction at Week 8|"Percentage of participants who discontinued corticosteroid use and achieved clinical remission (CDAI < 150) plus a reduction in hs-CRP of at least 50% from Baseline at Week 26 in participants who were taking steroids at Baseline and who achieved clinical response (decrease in CDAI of ≥ 70 points from Baseline) plus a reduction in hs-CRP of ≥ 30% From Baseline at Week 8.~CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450."|Week 26|All participants who were randomized and who were taking steroids at Baseline and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) plus a reduction in hs-CRP of at least 30% from Baseline at Week 8. Non-responder imputation.|||percentage of participants|||Number
2573016|NCT02499783|Secondary|Percentage of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission at Week 26 in Participants Who Were Taking Steroids at Baseline and Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8|CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.|Week 26|All participants who were randomized and who were taking steroids at Baseline and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 8. Non-responder imputation.|||percentage of participants|||Number
2573017|NCT02499783|Secondary|Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of At Least 50% From Baseline at Week 26 in Participants Who Achieved Clinical Response Plus at Least 30% Reduction in Hs-CRP From Baseline at Week 8|"Clinical response is defined as a decrease in CDAI ≥ 70 Points from Baseline~CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450."|Week 26|All participants who were randomized and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) plus at least 30% reduction in hs-CRP from Baseline at Week 8. Non-responder imputation.|||percentage of participants|||Number
2573018|NCT02499783|Secondary|Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline at Week 4|CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.|Week 4|ITT Set: all participants who were randomized. Non-responder imputation.|||percentage of participants|||Number
2573020|NCT02499783|Primary|Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4|CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.|Week 4|Intention to Treat (ITT) Set: all participants who were randomized. Non-responder imputation.|||percentage of participants|||Number
2573030|NCT02499406|Secondary|Coping as Assessed With the DBT Ways of Coping Checklist at 9months|Scale title: Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) effective coping subscale. Minimum score: 0. Maximum score: 3. Higher score indicates more frequent use of adaptive coping strategies. Lower score indicates less frequent use of adaptive coping strategies.|9 months|17 participants started the study; 12 contributed data on this measure at 9months|||score on a scale||Standard Deviation|Mean
2573031|NCT02499406|Secondary|Coping as Assessed With the DBT Ways of Coping Checklist at 6 Months|Scale title: Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) effective coping subscale. Minimum score: 0. Maximum score: 3. Higher score indicates more frequent use of adaptive coping strategies. Lower score indicates less frequent use of adaptive coping strategies.|6 months|17 participants started the study. 11 participants contributed data on this measure at 6month assessment.|||score on a scale||Standard Deviation|Mean
2573032|NCT02499406|Secondary|Coping as Assessed With the DBT (Dialectical Behavior Therapy) Ways of Coping Checklist at 3months|Scale title: Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL) effective coping subscale. Minimum score: 0. Maximum score: 3. Higher score indicates more frequent use of adaptive coping strategies. Lower score indicates less frequent use of adaptive coping strategies.|3 months|17 participants started the study. 15 contributed data on this measure at 3 months.|||score on a scale||Standard Deviation|Mean
2573033|NCT02499406|Secondary|Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 9months|Scale title: Difficulties in Emotion Regulation Scale (DERS). Scale range: 36-180. Higher score indicates greater difficulties regulating emotions. Lower score indicates fewer difficulties regulating emotions.|9 months|17 participants started the study. 12 contributed data on DERS at 9months.|||score on a scale||Standard Deviation|Mean
2573034|NCT02499406|Secondary|Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 6months (End of Intervention)|Scale title: Difficulties in Emotion Regulation Scale (DERS). Scale range: 36-180. Higher score indicates greater difficulties regulating emotions. Lower score indicates fewer difficulties regulating emotions.|6 months|17 participants started the study. 11 contributed data on DERS at 6months.|||score on a scale||Standard Deviation|Mean
2573035|NCT02499406|Secondary|Emotion Dysregulation as Assessed Using Difficulties in Emotion Regulation Scale at 3months|Scale title: Difficulties in Emotion Regulation Scale (DERS). Scale range: 36-180. Higher score indicates greater difficulties regulating emotions. Lower score indicates fewer difficulties regulating emotions.|3 months|17 participants started the study; 15 provided data on this measure at 3months.|||score on a scale||Standard Deviation|Mean
2573036|NCT02499406|Secondary|Suicidal Ideation on Suicidal Behavior Questionnaire at 9months|Scale title: Suicidal Behavior Questionnaire. Minimum value = 0, maximum value = 92. Higher score indicates greater suicidal ideation; lower score indicates lower suicidal ideation.|9 months|17 participants started the study. 12 contributed data on SBQ at 9month assessment.|||score on a scale||Standard Deviation|Mean
2573037|NCT02499406|Secondary|Suicidal Ideation on Suicidal Behavior Questionnaire at 6months|Scale title: Suicidal Behavior Questionnaire. Minimum value = 0, maximum value = 92. Higher score indicates greater suicidal ideation; lower score indicates lower suicidal ideation.|6 months|17 participants started the study. 12 contributed data on this measure at 6month assessment.|||score on a scale||Standard Deviation|Mean
2573038|NCT02499406|Secondary|Suicidal Ideation on Suicidal Behavior Questionnaire at 3months|Scale title: Suicidal Behavior Questionnaire. Minimum value = 0, maximum value = 92. Higher score indicates greater suicidal ideation; lower score indicates lower suicidal ideation.|3 months|17 participants started the study; 15 provided scores on this measure at 3month assessment.|||score on a scale||Standard Deviation|Mean
2573039|NCT02499406|Secondary|Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Follow-up|"Acceptability to participants on the Client Satisfaction Scale created for this study. Participants rated group satisfaction on 11 items using 7point scale. Scale is scored by calculating mean of the 11 items. Scale range is 1-7. A higher score indicates greater satisfaction; a lower score indicates greater dissatisfaction, with 4 as the midpoint."|9 months|17 participants started the study; 12 provided scores on this measure at 9-month assessment.|||score on a scale||Standard Deviation|Mean
2573040|NCT02499406|Secondary|Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Post-intervention|"Acceptability to participants on the Client Satisfaction Scale created for this study. Participants rated group satisfaction on 11 items using 7point scale. Scale is scored by calculating mean of the 11 items. Scale range is 1-7. A higher score indicates greater satisfaction; a lower score indicates greater dissatisfaction, with 4 as the midpoint."|6 months|17 participants started the study; 12 provided scores on this measure at 6-month assessment.|||score on a scale of satisfaction||Standard Deviation|Mean
2573041|NCT02499406|Secondary|Acceptability as Assessed by Positive Feedback on Written Satisfaction Evaluations Completed by Participants at Mid-point of Intervention|"Acceptability to participants on the Client Satisfaction Scale created for this study. Participants rated group satisfaction on 11 items using 7point scale. Scale is scored by calculating mean of the 11 items. Scale range is 1-7. A higher score indicates greater satisfaction; a lower score indicates greater dissatisfaction, with 4 as the midpoint."|3 months|17 participants started the study; 15 provided scores on this measure at 3-month assessment.|||score on a scale of satisfaction||Standard Deviation|Mean
2573042|NCT02499406|Primary|Feasibility as Assessed by Attendance at Sessions for Duration of Intervention (Percent of Sessions Attended)|Participation in skills group as assessed by attendance at sessions for duration of intervention (percent of sessions attended)|6 months|Percent of sessions attended|||percentage of sessions attended||Full Range|Mean
2573043|NCT02499380|Primary|Changes in 6 Minute Walk Distance (6MWD)|Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 3 months after final treatment of the RePneu coil. 6MWD was measured in meters.|Baseline, 3 months post final treatment|Intention to treat population with 6MWT data available at baseline and 3 months|||meters||Standard Deviation|Mean
2573148|NCT02498821|Secondary|Health Care Professional (HCP) Procedural Satisfaction (Overall)|"HCPs were asked to rate satisfaction with the procedure (overall) on a scale from 0 to 10 with 0 meaning not at all satisfied and 10 meaning extremely satisfied."|Measured immediately after the procedure completion (usually ranges from 0 to 300 minutes following procedure initiation).||||units on a scale||Standard Deviation|Mean
2573044|NCT02499380|Primary|Changes in 6 Minute Walk Distance (6MWD)|Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 12 months after the initial treatment of the RePneu coil. 6MWD was measured in meters.|Baseline, 12 months post initial treatment|Intention to treat population with 6MWT data available at baseline and 12 months|||meters||Standard Deviation|Mean
2573045|NCT02499263|Secondary|Change in the Composition of Fecal Microbiota From Baseline to Week 8 and Week 56|Composition of fecal microbiota (16S ribosomal ribonucleic acid (rRNA) gene sequencing) was measured at Week 0, Week 8, and Week 56. Fecal bacterial composition was determined using 16S sequencing. The obtained sequences were analyzed using the Ezbiocloud database and 16S microbiome pipeline to assess composition and diversity.|Week 0, Week 8, Week 56|This endpoint was not completed due to lack of data collection.||||||
2573046|NCT02499263|Secondary|Fecal Calprotectin Level at Week 56 in Participants Who Were Clinical Responders at Week 56|Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Week 56|ITT set of participants who were clinical responders at Week 56 and had evaluable data for this outcome|||mg/kg||Standard Deviation|Mean
2573047|NCT02499263|Secondary|Fecal Calprotectin Level at Week 8 in Participants Who Were Clinical Responders at Week 56|Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Week 8|ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8 and had evaluable data for this outcome|||mg/kg||Standard Deviation|Mean
2573048|NCT02499263|Secondary|Fecal Calprotectin Level at Week 56 in Participants Who Were Clinical Responders at Week 8|Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.|Week 56|ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8 and had evaluable data for this outcome.|||mg/kg||Standard Deviation|Mean
2573049|NCT02499263|Secondary|Fecal Calprotectin Level at Week 8 in Participants Who Were Clinical Responders at Week 8|Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.|Week 8|ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8 and had evaluable data for this outcome.|||mg/kg||Standard Deviation|Mean
2573050|NCT02499263|Secondary|Fecal Calprotectin Level at Week 56|Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.|Week 56|ITT set.|||mg/kg||Standard Deviation|Mean
2573051|NCT02499263|Secondary|Fecal Calprotectin Level at Week 8|Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.|Week 8|ITT set.|||mg/kg||Standard Deviation|Mean
2573052|NCT02499263|Secondary|Change in Full Mayo Score From Baseline to Week 56 in Participants Who Were Clinical Responders at Week 56|Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Baseline, Week 56|ITT set of participants who were clinical responders at Week 56|||score on a scale||Standard Deviation|Mean
2573053|NCT02499263|Secondary|Change in Full Mayo Score From Baseline to Week 8 in Participants Who Were Clinical Responders at Week 56|Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Baseline, Week 8|ITT set of participants who were clinical responders at Week 56 with evaluable data for this Outcome Measure.|||score on a scale||Standard Deviation|Mean
2573054|NCT02499263|Secondary|Change in Partial Mayo Score From Baseline to Week 8 in Participants Who Were Clinical Responders at Week 56|"The partial Mayo score is based on the Mayo score, which is a tool designed to measure disease activity for ulcerative colitis.~The partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in partial Mayo score indicates improvement."|Baseline, Week 8|ITT set of participants who were clinical responders at Week 56|||score on a scale||Standard Deviation|Mean
2573109|NCT02499146|Primary|Multiple-dose PK: Maximum Plasma Concentration at Steady State (Css,Max) for Palbociclib|Css,max of palbociclib in the multiple-dose part (Cycle 1) was observed directly from data.|Cycle 1: pre-dose on Day 19, Day 20, Day 21, and 2, 4, 6, 8, 10, 24, 48, 72, 96, 120 hours post dose on Day 21|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the multiple-dose part.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2573055|NCT02499263|Secondary|Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at Week 56|Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at Week 56. Endoscopic findings were scored on a scale from 0 to 3 (higher score, worse disease): 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration). Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. Mayo score measures disease activity for ulcerative colitis from 0 (normal or inactive disease) to 12 (severe disease), calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each ranging from 0 (normal) to 3 (severe disease). Negative change in Mayo score indicates improvement.|Week 56|ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.|||percentage of participants|||Number
2573056|NCT02499263|Secondary|Percentage of Participants Who Were Week 8 Responders With Mucosal Healing at Week 8|Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at Week 8. Endoscopic findings were scored on a scale from 0 to 3 (higher score, worse disease): 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration). Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. Mayo score measures disease activity for ulcerative colitis from 0 (normal or inactive disease) to 12 (severe disease), calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each ranging from 0 (normal) to 3 (severe disease). Negative change in Mayo score indicates improvement.|Week 8|ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.|||percentage of participants|||Number
2573057|NCT02499263|Secondary|Percentage of Participants With Mucosal Healing at Week 56|"Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at Week 56. Endoscopic findings were scored on a scale from 0 to 3 as follows:~0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). The higher the score, the more severe the disease."|Week 56|ITT set|||percentage of participants|||Number
2573058|NCT02499263|Secondary|Percentage of Participants With Mucosal Healing at Week 8|"Mucosal healing was defined as an endoscopy sub-score of 0 or 1 at week 8. Endoscopic findings were scored on a scale from 0 to 3 as follows:~0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). The higher the score, the more severe the disease."|Week 8|ITT set|||percentage of participants|||Number
2573059|NCT02499263|Secondary|Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at Week 56|Steroid free response was defined as participants who were in clinical response without the use of systemic steroids within the past 12 weeks prior to assessment (in Week 8 clinical responders). A participant was a Week 8 responder if they had a clinical response at Week 8. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Week 56|ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.|||percentage of participants|||Number
2573060|NCT02499263|Secondary|Percentage of Participants Who Were Week 8 Responders With Steroid-free Response at Week 8|Steroid free response was defined as participants who were in clinical response without the use of systemic steroids within the past 8 weeks prior to assessment (in Week 8 clinical responders).Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Week 8|ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.|||percentage of participants|||Number
2573061|NCT02499263|Secondary|Percentage of Participants With Steroid-free Response at Week 56|Steroid-free response was defined as participants who were in clinical response without the use of systemic steroids within the past 8 weeks prior to assessment. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Week 56|ITT set.|||percentage of participants|||Number
2573062|NCT02499263|Secondary|Percentage of Participants With Steroid-free Response at Week 8|Steroid-free response was defined as participants who were in clinical response without the use of systemic steroids within the past 8 weeks prior to assessment. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Week 8|ITT set.|||percentage of participants|||Number
2573063|NCT02499263|Secondary|Percentage of Participants Who Were Week 8 Responders With Steroid-free Remission at Week 56|Steroid free remission was defined as participants who were in remission without the use of systemic steroids within the past 12 weeks prior to assessment. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Week 56|ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.|||percentage of participants|||Number
2573064|NCT02499263|Secondary|Percentage of Participants Who Were Week 8 Responders With Steroid-free Remission at Week 8|Steroid-free remission was defined as participants who were in remission without the use of systemic steroids within the past 12 weeks prior to assessment. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Week 8|ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.|||percentage of participants|||Number
2573065|NCT02499263|Secondary|Percentage of Participants With Steroid-free Remission at Week 56|Steroid free remission was defined as participants who were in remission without the use of systemic steroids within the past 12 weeks prior to assessment.|Week 56|ITT set|||percentage of participants|||Number
2573066|NCT02499263|Secondary|Percentage of Participants With Steroid-free Remission at Week 8|Steroid free remission was defined as participants who were in remission without the use of systemic steroids from Visit 1 (Baseline) prior to assessment.|Week 8|ITT set|||percentage of participants|||Number
2573067|NCT02499263|Secondary|Percentage of Participants Who Were Week 8 Responders With Clinical Remission at Week 56|Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 56. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Week 56|ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.|||percentage of participants|||Number
2573068|NCT02499263|Secondary|Percentage of Participants Who Were Week 8 Responders With Clinical Remission at Week 8|Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 8. Clinical response was defined as reduction in complete full Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Week 8|ITT set. A participant was a Week 8 responder if they had a clinical response at Week 8.|||percentage of participants|||Number
2573069|NCT02499263|Secondary|Percentage of Participants With Clinical Remission at Week 56|Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 56. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Week 56|ITT set|||percentage of participants|||Number
2573070|NCT02499263|Secondary|Percentage of Participants With Clinical Remission at Week 8|Clinical remission was defined as the full Mayo score ≤2 points, with no individual sub-score exceeding 1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Week 8|ITT set|||percentage of participants|||Number
2573071|NCT02499263|Primary|Percentage of Participants With Clinical Response at Week 56|Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 56. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Week 56|ITT set|||percentage of participants||95% Confidence Interval|Number
2573072|NCT02499263|Primary|Percentage of Participants With Clinical Response at Week 24|Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 24. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Week 24|ITT set|||percentage of participants||95% Confidence Interval|Number
2573073|NCT02499263|Primary|Percentage of Participants With Clinical Response at Week 8|Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and PGA), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Week 8|ITT set: all participants that were intended to be treated with adalimumab. At Week 8, all participants who had received adalimumab treatment at least once were included and at Week 56, all participants who had clinical response at Week 8 were included.|||percentage of participants||95% Confidence Interval|Number
2573074|NCT02499263|Primary|Percentage of Participants Who Were Week 8 Responders With Durable Clinical Response at Week 56|Durable clinical response was defined as reduction in complete Full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at both Week 8 and 56. Clinical response was defined as reduction in complete full Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at Week 8. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Week 56|ITT set: all participants that were intended to be treated with adalimumab. At Week 8, all participants who had received adalimumab treatment at least once were included and at Week 56, all participants who had clinical response at Week 8 were included. A participant was a Week 8 responder if they had a clinical response at Week 8.|||percentage of participants||95% Confidence Interval|Number
2573075|NCT02499172|Primary|Adverse Pregnancy Outcome|The primary analysis will compare adverse pregnancy outcome (miscarriage and stillbirth) in Cohorts 1 and 3.|Upto 42 weeks from the date of last menstrual period||||Participants|||Count of Participants
2573076|NCT02499159|Secondary|Overall Hospital Cost|Overall hospital cost of patient procedure and stay will be assessed.|Total cost assessed from patient registration until discharge to home (usually 0-2 days).|Data on hospital cost was not collected.||||||
2573077|NCT02499159|Secondary|Days Until Return to Work|Using surveys, the number of days to return to work was assessed for patients who were able to return to work.|Assessed at 30 days post-procedure|At the 30-day call, 24 subjects in the Exparel group and 17 subjects in the standard group indicated that they were able to return to work. Number of days were assessed for these subjects.|||days||Inter-Quartile Range|Median
2573078|NCT02499159|Secondary|Return to Work|Using surveys, patients are asked if they have been able to return to work.|Assessed at 30 days post-procedure|42 subjects in the Exparel group and 47 patients in the standard group completed the 30-day survey.|||Participants|||Count of Participants
2573079|NCT02499159|Secondary|Return to Baseline Activity|Using surveys, patients are asked if they have been able to return to baseline activity levels.|Assessed at 30 days post-procedure|42 subjects in the Exparel group and 47 subjects in the standard group completed the 30 day survey.|||Participants|||Count of Participants
2573080|NCT02499159|Secondary|Hospital Length of Stay|Median length of stay in days until discharge.|From end of procedure until discharge, usually 0-2 days.||||days||Inter-Quartile Range|Median
2573081|NCT02499159|Secondary|Incidence of Paresthesias (30 Days)|Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves|Assessed at day 30 post-procedure|42 subjects in the Exparel group and 47 subjects in the standard group completed the 30-day survey.|||Participants|||Count of Participants
2573082|NCT02499159|Secondary|Incidence of Paresthesias (7 Days)|Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves since the procedure.|Assessed at day 7 post-procedure||||Participants|||Count of Participants
2573083|NCT02499159|Secondary|Analog Pain Scores (30 Days)|Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain.|Assessed at 30 days post-procedure|42 subjects in the Exparel group and 47 subjects in the standard group completed the 30-day survey.|||score on a scale from 0-10||Inter-Quartile Range|Median
2573084|NCT02499159|Secondary|Analog Pain Scores (7 Days)|Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain.|Assessed at day 7 post-procedure||||score on a scale from 0-10||Inter-Quartile Range|Median
2573085|NCT02499159|Primary|Overall Amounts of Pain Medications Consumed Through Post-operative Day 7|Using questionnaires, patients are asked if they took Dilaudid, Tylenol, Motrin, or other opioids and if so, how many tablets.|Assessed daily for 7 days post-procedure|4 participants from the Exparel group and 6 participants from the standard group did not return a questionnaire.|||tablets|||Number
2573086|NCT02499146|Secondary|Ratio Over Baseline for Thymidine Kinase (TK) Concentration|Blood samples were collected to provide serum for the assessments of TK activity. The concentrations of TK were determined using enzyme-linked immunosorbent assay (ELISA) method. Ratio of serum TK concentration at each specified time point over baseline value was presented.|Baseline (Day -1 pre-dose), lead-in phase Day 1 (4, 8, 10, 24, 72, 120 hours post dose), Cycle 1 Day 21 (4, 8, 10, 24, 72, 96, 120 hours post dose), Cycle 2 Day 1 pre-dose|"All enrolled and treated participants who had both pre-dose value and at least 1 post dose value for at least 1 biomarker. Number Analyzed refers to the number of evaluable participants for each specified time point."|||ratio||Geometric Coefficient of Variation|Geometric Mean
2573087|NCT02499146|Secondary|Ratio Over Baseline for Skin Biomarker Ki67 Expression|The Ki67 was one of the skin biomarkers and samples were assayed using IHC method. Ratio over baseline was calculated by dividing the percentage of Ki67 positive cells at each specified time point by baseline value.|Baseline (Day -1), lead-in phase Days 1 and 2, Cycle 1 Days 21, 22, 23, 24, 25, 26|"All enrolled and treated participants who had both pre-dose value and at least 1 post dose value for at least 1 biomarker. Number Analyzed refers to the number of evaluable participants for each specified time point."|||ratio||Geometric Coefficient of Variation|Geometric Mean
2573088|NCT02499146|Secondary|Ratio Over Baseline for Skin Biomarker Phosphorylated Retinoblastoma Protein (pRb) Expression|The pRb was one of the skin biomarkers and samples were assayed using immunohistochemistry (IHC) method. Ratio over baseline was calculated by dividing the H-score value for pRb at each specified time point by baseline value. The H-score value, which could range from 0 to 300 (strongest expression) with higher score representing stronger expression, was calculated from the total of each individual intensity of staining (0 [negative], 1+ [weak], 2+ [moderate], 3+ [strong]) multiplied by the percentages of cells (0 to 100) that represented that staining.|Baseline (Day -1), lead-in phase Days 1 and 2, Cycle 1 Days 21, 22, 23, 24, 25, 26|"All enrolled and treated participants who had both pre-dose value and at least 1 post dose value for at least 1 biomarker. Number Analyzed refers to the number of evaluable participants for each specified time point."|||ratio||Geometric Coefficient of Variation|Geometric Mean
2573089|NCT02499146|Secondary|Trough Plasma Concentration of Letrozole|Plasma samples were analyzed for letrozole concentrations using a validated, sensitive and specific high-performance liquid chromatography tandem mass spectrometric (HPLC/MS/MS) method.|pre-dose of Cycle 1 Days 19, 20, 21 and Cycle 2 Day 1|"Number of Participants Analyzed represents all enrolled and treated participants who had letrozole concentration data. Number Analyzed represents the number of such participants who had data at each specified time point."|||nanograms per milliliter (ng/mL)||Full Range|Median
2573090|NCT02499146|Secondary|1-Year PFS Probability|One-year PFS probability was defined as the probability (expressed as percentage) of PFS at 1 year after Cycle 1 Day 1.|1 year|All enrolled participants who started the treatment of Cycle 1.|||percentage of PFS||95% Confidence Interval|Number
2573091|NCT02499146|Secondary|Duration of Response|Duration of response was the time from first documentation of CR or PR to date of first documentation of PD or death for the participants with an objective response (CR or PR). The definitions of CR, PR, and PD per RECIST (version 1.1) can be found in the previous Outcome Measures.|Every 12 weeks from Cycle 1 Day 1, up to 144 weeks by primary completion date of 31 July 2018|All enrolled participants who started the treatment of Cycle 1 and achieved an objective response (CR or PR per RECIST version 1.1).|||months||95% Confidence Interval|Median
2573092|NCT02499146|Secondary|Percentage of Participants Achieving Disease Control (Disease Control Rate [DCR])|DCR was the percentage of participants achieving disease control (CR, PR or stable disease [SD] >=24 weeks from Cycle 1 Day 1 to PD or death due to any cause). The definitions for objective status of CR, PR, and PD per RECIST (version 1.1) can be found in the previous Outcome Measures. Per RECIST (version 1.1), objective status of SD: target lesions achieved SD (i.e., did not qualify for CR, PR or PD) while non-target diseases were assessed as non-CR/non-PD, indeterminate or missing, and there were no new lesions.|Every 12 weeks from Cycle 1 Day 1, up to 144 weeks by primary completion date of 31 July 2018|All enrolled participants who started the treatment of Cycle 1.|||percentage of participants||95% Confidence Interval|Number
2573093|NCT02499146|Secondary|Percentage of Participants Achieving Objective Response (Objective Response Rate [ORR])|ORR was the percentage of participants with an objective response (complete response [CR] or partial response [PR]). Per RECIST (version 1.1), objective status of CR: target lesions and non-target diseases achieved CR, without new lesions; objective status of PR: target lesions achieved CR or PR while non-target diseases were non-CR/non-PD, indeterminate or missing, and without new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target diseases, CR: disappearance of all non-target lesions and normalization of tumor marker levels; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits; Indeterminate: progression had not been determined and >=1 non-target sites were not assessed or assessment methods were inconsistent with those used at baseline.|Every 12 weeks from Cycle 1 Day 1, up to 144 weeks by primary completion date of 31 July 2018|All enrolled participants who started the treatment of Cycle 1.|||percentage of participants||95% Confidence Interval|Number
2573094|NCT02499146|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from Cycle 1 Day 1 to date of first documentation of disease progression (PD) or death due to any cause, whichever occurred first. Documentation of progression was by objective disease assessment as defined by the Response Evaluation Criteria in Solid Tumor (RECIST) (version 1.1). Objective status of PD was defined as a >=20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm; or unequivocal progression of pre-existing lesions for non-target disease; or appearance of new lesions.|Every 12 weeks from Cycle 1 Day 1, up to 144 weeks by primary completion date of 31 July 2018|All enrolled participants who started the treatment of Cycle 1.|||months||95% Confidence Interval|Median
2573095|NCT02499146|Secondary|Number of Participants Meeting the Categorical Summarization Criteria for QTcF and QTcB Parameters|QT interval (time from electrocardiogram [ECG] Q wave to the end of the T wave corresponding to electrical systole) corrected for heart rate using Fridericia's formula was QTcF and QT interval corrected for heart rate using Bazett's formula was QTcB. Categorical summarization criteria for QTcF and QTcB were as follows: 1) maximum absolute value of <450 msec, 450 to 480 msec, 481 to 500 msec, or >=500 msec; 2) maximum increase from baseline of <30 msec, 30 to <60 msec, or >=60 msec.|up to 2.8 years by primary completion date of 31 July 2018|All enrolled participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2573096|NCT02499146|Secondary|Number of Participants With Laboratory Test Abnormalities|The number of participants with the following laboratory test abnormalities meeting any of the Grades 1 to 4 criteria per the NCI CTCAE (version 4.0) was summarized: anemia, lymphopenia, neutropenia, platelet count decreased, white blood cell (WBC) decreased, alanine aminotransferase (ALT) increased, alkaline phosphatase increased, aspartate aminotransferase (AST) increased, bilirubin (total) increased, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, and hyponatremia.|up to 2.8 years by primary completion date of 31 July 2018|All enrolled participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2573146|NCT02498821|Secondary|Number of Medication Doses Missed Due to PICC Not Being Ready for Use||Measured from initiation to completion of procedure (usually from 0 to 300 minutes)||||Doses||Standard Deviation|Mean
2573097|NCT02499146|Secondary|Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade|Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by NCI CTCAE version 4.0: Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.|up to 2.8 years by primary completion date of 31 July 2018|All enrolled participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2573098|NCT02499146|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity on or after the first dose of investigational product administration. AEs included both SAEs and non-serious AEs. Causality to study treatment was determined by the investigator.|From first dose of study medication up to 28 days after last dose (up to 2.8 years by primary completion date of 31 July 2018)|All enrolled participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2573099|NCT02499146|Primary|Steady State Accumulation Ratio (Rss) for Palbociclib|Rss of palbociclib was calcualted as AUCss,tau/AUCinf, where AUCss,tau (tau=24 hours) was from multiple-dose part (Cycle 1) and AUCinf was from single-dose part (lead-in phase).|Lead-in phase: Day 1 pre-dose, 2, 4, 6, 8, 10, 24, 48, 72, 96 and 120 hours post dose; Cycle 1: pre-dose on Day 19, Day 20, Day 21, and 2, 4, 6, 8, 10, 24 hours post dose on Day 21|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the single-dose and multiple-dose part.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2573100|NCT02499146|Primary|Observed Accumulation Ratio (Rac) for Palbociclib|Rac of palbociclib was determined as AUCss,tau/AUCsd,tau, where AUCss,tau (tau=24 hours) was from multiple-dose part (Cycle 1) and AUCsd,tau was AUC24 from single-dose part (lead-in phase).|Lead-in phase: Day 1 pre-dose, 2, 4, 6, 8, 10, and 24 hours post dose; Cycle 1: pre-dose on Day 19, Day 20, Day 21, and 2, 4, 6, 8, 10, and 24 hours post dose on Day 21|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the single-dose and multiple-dose part.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2573101|NCT02499146|Primary|Multiple-dose PK: Peak to Trough Fluctuation at Steady State (PTF) for Palbociclib|PTF of palbociclib in the multiple-dose part (Cycle 1) was determined as (Css,max - Css,min)/Css,av. Css,max and Css,min were observed directly from data while Css,av was calculated as AUCss,tau/tau, where tau was 24 hours.|Cycle 1: pre-dose on Day 19, Day 20, Day 21, and 2, 4, 6, 8, 10, 24, 48, 72, 96, 120 hours post dose on Day 21|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the multiple-dose part.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2573102|NCT02499146|Primary|Multiple-dose PK: CL/F for Palbociclib|CL/F of palbociclib in the multiple-dose part (Cycle 1) was calculated as Dose/AUCss,tau, where AUCss,tau was the AUC within a dosing interval of tau (=24 hours) at steady state.|Cycle 1: pre-dose on Day 19, Day 20, Day 21, and 2, 4, 6, 8, 10, and 24 hours post dose on Day 21|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the multiple-dose part.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2573103|NCT02499146|Primary|Multiple-dose PK: t1/2 for Palbociclib|t1/2 of palbociclib in the multiple-dose part (Cycle 1) was calculated as ln (2)/kel, where kel was the terminal phase rate constant following multiple-dose calculated by a linear regression of the log-linear concentration-time curve.|Cycle 1: pre-dose on Day 19, Day 20, Day 21, and 2, 4, 6, 8, 10, 24, 48, 72, 96, 120 hours post dose on Day 21|All enrolled and treated participants who had at least 1 PK parameter of primary interest and a well characterized terminal phase in the multiple-dose part .|||hours||Standard Deviation|Mean
2573104|NCT02499146|Primary|Multiple-dose PK: Vz/F for Palbociclib|Vz/F of palbociclib in the multiple-dose part (Cycle 1) was calculated as Dose/(AUCss,tau * kel), where AUCss,tau was the AUC within a dosing interval of tau (=24 hours) at steady state and kel was the terminal phase rate constant following multiple-dose calculated by a linear regression of the log-linear concentration-time curve.|Cycle 1: pre-dose on Day 19, Day 20, Day 21, and 2, 4, 6, 8, 10, 24, 48, 72, 96, 120 hours post dose on Day 21|All enrolled and treated participants who had at least 1 PK parameter of primary interest and a well characterized terminal phase in the multiple-dose part.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2573105|NCT02499146|Primary|Multiple-dose PK: Time to Reach Maximum Plasma Concentration at Steady State (Tss,Max) for Palbociclib|Tss,max of palbociclib in the multiple-dose part (Cycle 1) was observed directly from data as time of first occurrence within tau (=24 hours) at steady state.|Cycle 1: pre-dose on Day 19, Day 20, Day 21, and 2, 4, 6, 8, 10, and 24 hours post dose on Day 21|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the multiple-dose part.|||hours||Full Range|Median
2573106|NCT02499146|Primary|Multiple-dose PK: Average Plasma Concentration at Steady State (Css,av) for Palbociclib|Css,av of palbociclib in the multiple-dose part (Cycle 1) was calculated as AUCss,tau/tau, where tau was 24 hours.|Cycle 1: pre-dose on Day 19, Day 20, Day 21, and 2, 4, 6, 8, 10, and 24 hours post dose on Day 21|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the multiple-dose part.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2573107|NCT02499146|Primary|Multiple-dose PK: AUC Within a Dosing Interval of Tau (=24 Hours) at Steady State (AUCss,Tau) for Palbociclib|AUCss,tau of palbociclib in the multiple-dose part (Cycle 1) was determined by linear/log trapezoidal method.|Cycle 1: pre-dose on Day 19, Day 20, Day 21, and 2, 4, 6, 8, 10, and 24 hours post dose on Day 21|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the multiple-dose part.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2573108|NCT02499146|Primary|Multiple-dose PK: Minimum Plasma Concentration at Steady State (Css,Min) for Palbociclib|Css,min of palbociclib in the multiple-dose part (Cycle 1) was observed directly from data.|Cycle 1: pre-dose on Day 19, Day 20, Day 21, and 2, 4, 6, 8, 10, 24, 48, 72, 96, 120 hours post dose on Day 21|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the multiple-dose part.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2573110|NCT02499146|Primary|Single-dose PK: Apparent Volume of Distribution (Vz/F) for Palbociclib|Vz/F for palbociclib in the single-dose part (lead-in phase) was calculated as Dose/(AUCinf * kel).|Lead-in phase: Day 1 pre-dose, 2, 4, 6, 8, 10, 24, 48, 72, 96 and 120 hours post dose|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the single-dose part.|||liters||Geometric Coefficient of Variation|Geometric Mean
2573111|NCT02499146|Primary|Single-dose PK: Apparent Oral Clearance (CL/F) for Palbociclib|CL/F for palbociclib in the single-dose part (lead-in phase) was calculated as Dose/AUCinf.|Lead-in phase: Day 1 pre-dose, 2, 4, 6, 8, 10, 24, 48, 72, 96 and 120 hours post dose|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the single-dose part.|||liters per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2573112|NCT02499146|Primary|Single-dose PK: Terminal Half-Life (t1/2) for Palbociclib|t1/2 for palbociclib in the single-dose part (lead-in phase) was calculated as Loge(2)/kel.|Lead-in phase: Day 1 pre-dose, 2, 4, 6, 8, 10, 24, 48, 72, 96 and 120 hours post dose|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the single-dose part.|||hours||Standard Deviation|Mean
2573113|NCT02499146|Primary|Single-dose PK: Mean Residence Time (MRT) for Palbociclib|MRT for palbociclib in the single-dose part (lead-in phase) was calculated as AUMCinf/AUCinf, where AUMCinf was area under the first moment curve from time 0 to infinity.|Lead-in phase: Day 1 pre-dose, 2, 4, 6, 8, 10, 24, 48, 72, 96 and 120 hours post dose|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the single-dose part.|||hours||Standard Deviation|Mean
2573114|NCT02499146|Primary|Single-dose PK: Rate Constant for Terminal Phase (Kel) for Palbociclib|Kel for palbociclibo in the single-dose part (lead-in phase) was obtained by linear regression of the log-linear concentration-time curve.|Lead-in phase: Day 1 pre-dose, 2, 4, 6, 8, 10, 24, 48, 72, 96 and 120 hours post dose|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the single-dose part.|||per hour||Standard Deviation|Mean
2573115|NCT02499146|Primary|Single-dose PK: AUC From Time 0 Extrapolated to Infinite Time (AUCinf) for Palbociclib|AUCinf for palbociclib in the single-dose part (lead-in phase) was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the rate constant for terminal phase obtained by linear regression of the log-linear concentration-time curve.|Lead-in phase: Day 1 pre-dose, 2, 4, 6, 8, 10, 24, 48, 72, 96 and 120 hours post dose|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the single-dose part.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2573116|NCT02499146|Primary|Single-dose PK: AUC From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Palbociclib|AUClast for palbociclib in the single-dose part (lead-in phase) was obtained by linear/log trapezoidal method.|Lead-in phase: Day 1 pre-dose, 2, 4, 6, 8, 10, 24, 48, 72, 96 and 120 hours post dose|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the single-dose part.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2573117|NCT02499146|Primary|Single-dose PK: AUC From Time 0 to the Time 24 Hours (AUC24) for Palbociclib|AUC24 is AUCtau, where the dosing interval (tau) is 24 hours. AUC24 in the single-dose part (lead-in phase) for palbociclib was obtained by linear/log trapezoidal method.|Lead-in phase: Day 1 pre-dose, 2, 4, 6, 8, 10, and 24 hours post dose|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the single-dose part.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2573118|NCT02499146|Primary|Single-dose PK: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Time 10 Hours (AUC10) for Palbociclib|AUC10 for palbociclib in the single-dose part (lead-in phase) was obtained by linear/log trapezoidal method.|Lead-in phase: Day 1 pre-dose, 2, 4, 6, 8, and 10 hours post dose|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the single-dose part.|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2573119|NCT02499146|Primary|Single-dose PK: Time to Reach Maximum Plasma Concentration (Tmax) for Palbociclib|Tmax for palbociclib in the single-dose part (lead-in phase) was observed directly from data as time of first occurrence.|Lead-in phase: Day 1 pre-dose, 2, 4, 6, 8, 10, 24, 48, 72, 96 and 120 hours post dose|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the single-dose part.|||hours||Full Range|Median
2573120|NCT02499146|Primary|Single-dose Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) for Palbociclib|Cmax of palbociclib in the single-dose part (lead-in phase) was observed directly from data.|Lead-in phase: Day 1 pre-dose, 2, 4, 6, 8, 10, 24, 48, 72, 96 and 120 hours post dose|All enrolled and treated participants who had at least 1 PK parameter of primary interest in the single-dose part.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2573121|NCT02499120|Secondary|Ctrough and Cendinf, WPM-Ctrough and WPM-Cendinf at Steady State for Serum Cetuximab|Ctrough is steady-state pre-dose concentration. Cendinf is steady-state end-of-infusion concentration. Ctrough and Cendinf were observed directly from data. WPM-Ctrough and WPM-Cendinf are within-participant mean steady-state pre-dose concentration and end-of-infusion concentration. Acceptance criteria for a steady-state Cendinf was defined as a PK sample that was 1) collected after at least 3 consecutive weeks of cetuximab IV infusions without interruption or prior dose reduction and 2) was collected at the end of cetuximab infusion time +/- 10% of the actual duration of the cetuximab infusion.|Pre-dose and end-of infusion of Day 15 in Cycle 1 and Cycle 2|The analysis population included all as-treated participants, who were treated with the study treatments and had at least measured plasma concentration for at least 1 analyte (palbociclib and/or cetuximab)|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2573122|NCT02499120|Secondary|Trough Plasma Concentration (Ctrough) and Within-patient Mean Steady-state Pre-dose Concentration (WPM-Ctrough) at Steady State for Palbociblib|Ctrough is steady-state pre-dose concentration, which was observed directly from data. WPM-Ctrough is within-participant mean steady-state pre-dose concentration. For palbociclib, a steady-state trough was to be defined as a pre-dose plasma concentration following at least 7 consecutive days of 125 mg daily dose without dosing interruption and the time window for the PK collection was to be between 24 hr +/- 2 hr and 24 min post-dose the day prior to PK collection and no more than 1 hr post-dose on the day of PK collection.|Pre-dose of Day 15 in Cycle 1 and Cycle 2|The analysis population included all as-treated participants, who were treated with the study treatments and had at least measured plasma concentration for at least 1 analyte (palbociclib and/or cetuximab)|||ng/ml||Standard Deviation|Mean
2573123|NCT02499120|Secondary|Summary of PFS and OS Based on Investigator Assessment by Rb Expression >= 1%|Rb expression in the palbociclib and cetuximab treatment group, the relationship of the biomarker (individually) with PFS and OS were explored using graphical methods such as box plots, at baseline. The tumors of participants were Rb-positive, which was defined by Rb IHC with>=1% positive tumor cells.|Screening|The analysis population included all participants treated with cetuximab in combination with placebo or palbociclib who had at least 1 baseline biomarker assessment.|||months||95% Confidence Interval|Median
2573124|NCT02499120|Secondary|Summary of PFS and OS for P16 Negative (%Positive Tumor Cells < 70%)|A central test was defined as the tumor tissue-based p16 IHC test performed at a central laboratory (Ventana). The analysis of concordance between HPV status as assessed by local or central laboratory included the number and percentage of paticipants with p16 detected or not detected at the central laboratory, given that all local testing must have been negative for HPV in order for the patient to be eligible for the study. Initial analysis of the p16 status was based on the conventional cutoff of 70% p16-positive tumor cells to call out cases that might be considered HPV-positive. P16 expression was scored as positive if strong and diffuse nuclear and cytoplasmic staining was present in at least 70% of the tumor cells.|Screening|The analysis population included all participants treated with cetuximab in combination with placebo or palbociclib who had at least 1 baseline biomarker assessment.|||months||95% Confidence Interval|Median
2573125|NCT02499120|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Head and Neck Module35 (EORTC QLQ-H&N35)|"The EORTC QLQ-H&N35 is designed to be used together with the core QLQ-C30. The recall period for the items in the module was the past week. Items hn1 to hn30 were scored on 4 point Likert type categorical scales (not at all, a little, quite a bit, very much). Items hn31 to hn35 had a no/yes response format. The scores were transformed into 0 to 100 scales, with a high score implying a high level of symptoms.Negative changes from baseline indicate deterioration in functioning / global QoL scales and improvement in symptom scales."|Baseline up to PCD (about 34 months)|The analysis population included all ITT participants, who had both baseline and at least 1 follow-up PRO assessment before treatment discontinuation.|||units on a scale||95% Confidence Interval|Mean
2573126|NCT02499120|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)|"The EORTC QLQ-C30 is a 30 item questionnaire composed of 5 multi-item functional subscales (physical, role, cognitive, emotional, and social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global health/quality of life (QOL) subscale, and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation, and the financial impact of cancer). The questionnaire employed twenty-eight 4 point Likert scales with responses from not at all to very much and two 7 point Likert scales for global health and overall QOL. For functional and global QOL scales, higher scores represented a better level of functioning and all scores were converted to a 0 to 100 scale. For symptom oriented scales, a higher score represented more severe symptoms, and all scores were converted to a 0-100 scale. Negative changes from baseline indicate deterioration in functioning / global QoL scales and improvement in symptom scales."|Baseline up to PCD (about 34 months)|The analysis population included all ITT participants, who had both baseline and at least 1 follow-up patient reported outcome (PRO) assessment before treatment discontinuation.|||units on a scale||95% Confidence Interval|Mean
2573127|NCT02499120|Secondary|Number of Participants With Laboratory Abnormalities|The hematology, chemistry and coagulation tests were included in the laboratory examination. Hematology evaluation included hemoglobin, platelets, white blood cell, absolute neutrophils, absolute lymphocytes. Chemistry evaluation included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose (non-fasted), albumin, phosphorus or phosphate and hemoglobin A1c (HbA1c). Coagulation evaluation included activated partial thromboplastin time/partial thromboplastin time, international normalized ratio (INR) or prothrombin time.|Baseline up to PCD (about 34 months)|The analysis population included all participants with at least 1 observation of the laboratory test while on study treatment or during lag time.|||Participants|||Count of Participants
2573128|NCT02499120|Secondary|Number of Participants With Treatment-Emergent Adverse Events(TEAEs)|AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.|Baseline up to PCD (about 34 months)|The analysis population included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.|||Participants|||Count of Participants
2573129|NCT02499120|Secondary|Duration of Response (DR)|DR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the date response ended (ie, date of PD or death) - first CR or PR date + 1]/30.4.|Baseline up to PCD (about 34 months)|DR was only calculated for the subgroup of all ITT participants with an objective tumor response.|||months||95% Confidence Interval|Median
2573130|NCT02499120|Secondary|Percentage of Participants With Clinical Benefit Response (CBR)|CBR was defined as the overall CR, PR, or stable disease>=24 weeks according to the RECIST version 1.1. Clinical benefit response rate was defined as the proportion of participants with CR, PR, or stable disease>= 24 weeks relative to all randomized participants and randomized participants with measurable disease at baseline.|Baseline up to PCD (about 34 months)|The analysis population was ITT population, which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2573131|NCT02499120|Secondary|Percentage of Participants With Objective Response (OR)|OR was defined as the overall complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Objective response rate was defined as the proportion of participants with best overall response (BOR) of CR or PR relative to all randomized.|Baseline up to PCD (about 34 months)|The analysis population was ITT population, which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2573132|NCT02499120|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of the first documentation of objective progression of disease (PD) or death due to any cause, whichever was earlier. Estimates of the PFS curves from the Kaplan Meier method were presented.|Baseline up to PCD (about 34 months)|The analysis population was intent-to-treat (ITT) population, which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
2573133|NCT02499120|Primary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death due to any cause. OS (in months) was calculated as (date of death − randomization date +1)/30.4. For participants lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Participants lacking survival data beyond randomization had their OS times be censored at randomization. Estimates of OS and its 95% confidence interval were determined using Kaplan-Meier method.|Baseline up to primary completion date (PCD) (about 34 months)|The analysis population was intent-to-treat (ITT) population, which included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.|||months||95% Confidence Interval|Median
2573134|NCT02499029|Secondary|PTSD Symptoms|PTSD Checklist - Military (PCL-M) The PCL-M is a seventeen question self-report, scored on a scale from 1 to 5, with possible scores ranging from 17 to 85. The scores from each question are summed to get a total score (17-85). A higher total indicates a higher severity of PTSD symptoms.|8 weeks||||units on a scale||Standard Deviation|Mean
2573135|NCT02499029|Secondary|Craving|Visual Analogue Scale (VAS) The VAS measures alcohol craving on a scale from 0 to 10. A higher score indicates a higher level of craving.|8 weeks||||units on a scale||Standard Deviation|Mean
2573136|NCT02499029|Secondary|Depression|Beck Depression Inventory (BDI) The BDI measures presence and severity of depression. It has 21 questions that are rated from 0-3 with a highest possible score of 63. A higher score indicates a higher severity of depression.|8 weeks||||units on a scale||Standard Deviation|Mean
2573137|NCT02499029|Primary|PTSD Symptoms|Clinician Administered PTSD Scale IV (CAPS) The CAPS IV measures seventeen symptoms based on intensity and frequency. Intensity and frequency scores are summed to create a severity score for each question. Severity scores are summed to get a total score. A higher total score indicates a higher severity of PTSD symptoms.The full range for CAPS IV is 0-136.|8 weeks||||units on a scale||Standard Deviation|Mean
2573138|NCT02498834|Primary|Asthma Quality-of-life Score|Adolescent quality-of-life was measured as a continuous variable. The investigators used the standardized version of the Juniper pediatric asthma quality-of-life questionnaire. The questionnaire contains 23 items and has a reliability of 0.84. Scores can range from 1.0 to 7.0, and a higher score means a better outcome.|12 month follow-up|One intervention group patient was excluded because they had to leave immediately after the final visit and did not complete the 12-month survey.|||score on a scale||Standard Deviation|Mean
2573139|NCT02498834|Primary|Adolescent Asthma Management Self-efficacy Score|Adolescent asthma management self-efficacy was measured using a 14-item scale that has been shown to have a reliability of 0.87. Prior work in asthma has found asthma management self-efficacy to change in response to an intervention. Scores range from 14 to 70 and a higher score means a better outcome.|12 month follow-up|One intervention group patient was excluded because they had to leave immediately after the final visit and did not complete the 12-month survey.|||score on a scale||Standard Deviation|Mean
2573140|NCT02498834|Primary|Number of Participants Achieving Asthma Control|"This will be measured via the 5-item Asthma Control Test, responses are summed to indicate a score ranging from 5 (poor asthma control) to 25 (complete asthma control). A higher score means a better outcome. A score of above 19 is considered well controlled."|12 month follow-up|One intervention group patient was excluded because they had to leave immediately after the final visit and did not complete the 12-month survey.|||Participants|||Count of Participants
2573141|NCT02498821|Other Pre-specified|Mean Total Procedural Cost From Initiation of Procedure (Opening of PICC Kit) to Catheter Tip Confirmation (Release for IV Therapy)|Cost calculated as follows: mean (sum of material cost per PICC insertion, X-ray cost per PICC insertion, non-interventional radiology (IR) labor cost per PICC insertion, IR labor cost per PICC insertion).|Usually ranges from 0 to 300 minutes||||US dollars||Standard Deviation|Mean
2573142|NCT02498821|Other Pre-specified|Nurse Time Associated With Malposition Adjustment After Initial PICC Placement (Per Event)|Nurse time associated with a malposition was defined as the time between when the nurse opened gathered materials for correcting the malposition (e.g., PICC kit, dressing change kit, saline, syringe) and when the subject was released for IV therapy.|Usually ranges from 0 to 30 minutes||||minutes|events|Standard Deviation|Mean
2573143|NCT02498821|Other Pre-specified|Nurse Time Associated With Initial PICC Placement (Per Patient)|Nurse time associated with initial PICC placement was defined as the time between when the nurse arrived at the subject and when the nurse left the room, minus the amount of time it took to conduct the research consent with the subject for the study; it includes time spent gathering supplies (before entering the subject's room) and any consents obtained for the PICC procedure (not study-related consents).|Usually ranges from 0 to 150 minutes||||minutes||Standard Deviation|Mean
2573144|NCT02498821|Secondary|Number of Overtime Hours Worked Per PICC Placement Procedure||Measured from initiation to completion of procedure (usually from 0 to 5 hours)||||hours||Standard Deviation|Mean
2573145|NCT02498821|Secondary|Number of Lab Draws Missed Due to PICC Not Being Ready for Use||Measured from initiation to completion of procedure (usually from 0 to 300 minutes)||||Lab draws||Standard Deviation|Mean
2573153|NCT02498769|Secondary|Number of Participants With Adverse Events|The total number of postoperative complications (including infectious, neurologic, and renal complications, as well as mortality) and the number of subjects with complications will be monitored and compared between groups.|Adverse events from the time of surgery through hospital discharge, up to 2 weeks||||Participants|||Count of Participants
2573154|NCT02498769|Secondary|Length of Stay|Total and ICU length of stay will be determined by examining medical records for the length of inpatient hospitalization, assessed over the entire study period (up to two years). ICU and hospital LOS will be recorded and compared between groups|ICU length of stay was measured from time of surgery to time of ICU discharge. Post-operative length of stay was measured from time of surgery to time of hospital discharge.||||time in hours||Inter-Quartile Range|Median
2573155|NCT02498769|Secondary|Number of Participants With In-hospital POAF|Patients will be seen on a daily basis and the occurrence of POAF compared between groups.|The incidence of in-hospital POAF will be tracked throughout the hospitalization (up to two weeks)||||Participants|||Count of Participants
2573156|NCT02498769|Primary|Time to In-hospital Post-operative Atrial Fibrillation (POAF)|Patients will be seen on a daily basis and the timing of POAF compared between groups. The occurrence of in-hospital POAF will be tracked throughout the hospitalization (up to two weeks) and the time from surgery to the first and subsequent episodes of POAF recorded and compared between groups. POAF will be determined by ECG or telemetry.|From the time of ICU arrival until the time of first documented POAF, or discharge whichever came first, assessed up to 2 weeks||||hours||Standard Error|Mean
2573157|NCT02498678|Secondary|Monitor Settings - Sensitivity|Sensitivity calculated by the monitor calibration, It is a numeric value that ranges from 1 to 512, but there is no measurement unit provided. Using the default CAL 2 function, the TOF-Watch® SX monitor automatically determines the sensitivity for a specific patient. The sensitivity can be adjusted between 1 and 512, where 512 represents the most sensitive setting. A sensitivity setting of 157 is the default value. This value represents how the monitor measures motor response of the patient to electrical stimulation of train of four (TOF). If the patient has intense motor response, the monitor reduces its sensitivity. If the patient has poor motor response, the monitor increase your sensitivity.|An expected average of 60 minutes||||units on a scale from 1 to 512||Standard Deviation|Mean
2573158|NCT02498678|Secondary|Monitor Settings - Electric Current|Electric current (milliampere) calculated by the monitor calibration|An expected average of 60 minutes||||milliampere||Standard Deviation|Mean
2573159|NCT02498678|Secondary|Time to Obtain T1 Height Stability|Time, in minutes, for the stabilization T1 height (maximum acceptable variation of up to 5%) before administration of neuromuscular blocking agent. According to the guidelines for good clinical research practice in pharmacodynamics studies of neuromuscular blocking agents, the monitor must present a stable response of T1 height (baseline) for a period of 2-5 min before administration of an neuromuscular blocking agents.|An expected average of 60 minutes||||seconds||Standard Deviation|Mean
2573160|NCT02498678|Primary|T1 Height|T1 height documentation when train of four reaches 0,9 (90%)|An expected average of 60 minutes||||percentage of T1 height||Standard Deviation|Mean
2573161|NCT02498678|Primary|Train of Four 0,9 (90%)|Time to recovery to train of four 0,9 (90%). When the fourth stimulus value (T4) divided by the first stimulus (T1) reaches the ratio of 0.9 (T4 / T1)|An expected average of 60 minutes||||minutes||Standard Deviation|Mean
2573162|NCT02498652|Primary|Cohort 2 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))|Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)|Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)||||Percentage (%) Change||Standard Error|Mean
2573163|NCT02498652|Primary|Cohort 2 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))|Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)|Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)||||Percentage (%) Change||Standard Error|Mean
2573164|NCT02498652|Primary|Cohort 2 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.|Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)|Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)||||mg/dL||Standard Error|Mean
2573165|NCT02498652|Secondary|Number of Participants With Treatment-Emergent Adverse Events||11 weeks||||Number of participants|||Number
2573166|NCT02498652|Secondary|Apparent Terminal Half-life (t1/2)|t1/2 of Allopurinol alone or in combination with RDEA3170|Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)||||hr||95% Confidence Interval|Geometric Mean
2573167|NCT02498652|Secondary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)|AUC last of Allopurinol alone or in combination with RDEA3170|Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)||||µg·hr/mL||95% Confidence Interval|Geometric Mean
2573168|NCT02498652|Secondary|Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)|AUC 0-24 of Allopurinol alone or in combination with RDEA3170|Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)||||µg·hr/mL||95% Confidence Interval|Geometric Mean
2573169|NCT02498652|Secondary|Time of Occurrence of Maximum Observed Concentration (Tmax)|Tmax of Allopurinol alone or in combination with RDEA3170|Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)||||hr||95% Confidence Interval|Geometric Mean
2573170|NCT02498652|Secondary|Maximum Observed Concentration (Cmax)|Cmax of Allopurinol alone or in combination with RDEA3170|Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)||||µg/mL||95% Confidence Interval|Geometric Mean
2573171|NCT02498652|Primary|Cohort 2 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))|Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)|Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)||||Maximum Percentage (%) Change||Standard Error|Mean
2573172|NCT02498652|Primary|Cohort 1 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))|Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)|Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)||||Percentage (%) Change||Standard Error|Mean
2573173|NCT02498652|Primary|Cohort 1 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))|Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)|Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)||||Percentage (%) Change||Standard Error|Mean
2573174|NCT02498652|Primary|Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.|Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)|Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)||||mg/dL||Standard Error|Mean
2573175|NCT02498652|Primary|Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))|Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)|Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)||||Maximum Percentage (%) Change||Standard Error|Mean
2573176|NCT02498522|Primary|Miscarriage Rate||6 months||||participants||95% Confidence Interval|Number
2573177|NCT02498483|Secondary|Pulse Oximetry||Baseline 4 hours||||percentage of oxygen saturation||Full Range|Mean
2573178|NCT02498483|Secondary|Respiratory Rate||Baseline and 4 hours||||breaths per minute||Full Range|Mean
2573179|NCT02498483|Secondary|Change in Salivary Cortisol Rise||Baseline and 4 hours|Only subjects who were able to provide saliva were incorporated into the data analysis. One subject in the acetaminophen arm could not provide a saliva sample for analysis, and 2 subjects in the control arm could not provide saliva samples for analysis.|||nmol/L||Full Range|Mean
2573180|NCT02498483|Secondary|Heart Rate||Baseline and 4 hours||||Beats per minute||Full Range|Mean
2573181|NCT02498483|Primary|Neonatal Infant Pain Scale (NIPS)|"The Neonatal Infant Pain Scale (NIPS) is a behavioral scale and can be utilized with both full-term and pre-term infants. The tool uses the behaviors that nurses have described as being indicative of infant pain or distress. It is composed of six (6) indicators: facial expression, cry, breathing patterns, arms, legs and state of arousal. Each behavioral indicator is scored with 0 or 1 except cry, which has three possible descriptors therefore, being scored with a 0, 1 or 2. Infants are observed for one minute in order to fully assess each indicator. Total pain scores range from 0-7, with a score of 0-2 indicating mild to no pain and no suggested intervention (better outcome) to a score >4 indicating severe pain, suggesting non-pharmacological and/or pharmacological interventions may be needed."|Baseline and 4 hours||||score on a scale||Full Range|Mean
2573182|NCT02498418|Primary|Number of Participants Who Achieved Clinical Cure at TOC Visit (Within 24 to 72 Hours From the Time of Last Dose): Modified Intent-to-Treat (mITT) Population|"Clinical cure was defined as either of the following: No stools or only formed stools within a 48-hour period and no fever, with or without other enteric symptoms or; No watery stools or no more than 2 soft stools passed within a 24-hour period with no fever and no other enteric symptoms except for mild excess gas/flatulence. Participants discontinued early for reasons other than lack of treatment effect after completing 9 doses within 72 hours from the time of first dose and for participants whose condition worsened and who required alternate or supplemental therapy for the treatment of travelers' diarrhea were included in the mITT population analysis using LOCF."|TOC visit (Day 5, 6 ,or 7)|mITT population included all randomized participants who met all inclusion and none of the exclusion criteria, received at least 1 dose of study drug and provided efficacy and safety data after 1 dose of study drug. LOCF method was used as applicable for this population.|||Participants|||Count of Participants
2573183|NCT02498418|Secondary|Percentage of Participants Who Achieved Microbiological Cure at TOC Visit (Within 24 to 72 Hours From the Time of Last Dose)|Participants were considered to have achieved microbiological cure if the pathogen identified at Day 1 is no longer found in the stool at the TOC visit.|TOC visit (Day 5, 6, or 7)|mITT population: all randomized participants who met all inclusion and none of the exclusion criteria, received at least 1 dose of study drug and provided efficacy and safety data after 1 dose. 'Overall number of participants analyzed'=participants evaluable for this endpoint. 'Number analyzed'=participants evaluable for the specified categories.|||percentage of participants|||Number
2573184|NCT02498418|Secondary|Time to Last Unformed Stool (TLUS)|TLUS was defined as the interval beginning with the first dose of study drug and ending with the last unformed stool passed within a period of 120 hours (within 48 hours from the time of last dose [at 72 hours]). Mathematically, TLUS was calculated as follows. TLUS (hours) = date/time of last unformed stool within 48 hours from the time of last dose - date/time of first dose.|Day 1 to Day 5|mITT population included all randomized participants who met all inclusion and none of the exclusion criteria, received at least 1 dose of study drug and provided efficacy and safety data after 1 dose of study drug. Here, 'Overall number of participants analyzed'=participants with TLUS in the mITT population.|||hours||Full Range|Median
2573185|NCT02498418|Primary|Number of Participants Who Achieved Clinical Cure at Test of Cure (TOC) Visit (Within 24 to 72 Hours From the Time of Last Dose): Per-Protocol (PP) Population|Clinical cure was defined as either of the following: No stools or only formed stools within a 48-hour period and no fever, with or without other enteric symptoms or; No watery stools or no more than 2 soft stools passed within a 24-hour period with no fever and no other enteric symptoms except for mild excess gas/flatulence. Bioequivalence evaluation between test (generic rifaximin 200 mg tablets) and reference groups (xifaxan 200 mg tablets) was conducted in this endpoint, hence placebo group was not included. Participants who were discontinued early from the study due to lack of treatment effect after completing 9 doses within 72 hours from the time of first dose were included in the PP population using Last Observation Carried Forward (LOCF) method. Additionally, participants whose condition worsened and who required alternate or supplemental therapy for the treatment of travelers' diarrhea were discontinued and included in the PP population analysis using LOCF.|TOC visit (Day 5, 6 or 7)|PP population: randomized participants, met inclusion/exclusion criteria, took 3 days of study drug, were compliant with study drug dose, and completed Visit 3 within 24-72 hours from the time of last dose, with no major protocol deviations/violations that would affect treatment evaluation. LOCF method was used as applicable for this population.|||Participants|||Count of Participants
2573319|NCT02496702|Secondary|Change From Baseline in Test Score of Static Balance at Week 14.|Static Balance will be measured using Wii Balance Board, which have proven to be a valid measure of balance (Sgró 2014). This measure will be done using an application developed by Francesco Sgró and colleagues (Sgró 2014). Baseline score compared to score at week 14.|Baseline and at week 14|Data were not collected.||||||
2573186|NCT02498236|Primary|Pupil Dilation While Observing Faces|"This primary outcome measure is pupil size recorded during a facial affect identification task. In this task, participants view faces portraying happy, afraid, or neutral faces; scrambled images of the faces were also shown. There were 64 trials: 16 trials per each image type. The primary measure was the difference in pupil size averaged over the happy and fearful faces from the scrambled face condition. A positive value indicates greater pupil dilation relative to the scrambled face; a negative value indicates greater pupil constriction relative to the scrambled face.~Baseline was defined as the median pupil width 1 second prior to stimulus onset. Pupil sizes during each trial were baseline-corrected by dividing them by baseline median width. Resulting pupil size timecourses were averaged within-subject for each type of stimulus (happy, afraid, neutral, scrambled). The primary dependent variable was computed by taking the average of the change in pupil size between 1 and 3 s."|Baseline, 1 Week||||arbitrary units||Standard Deviation|Mean
2573187|NCT02498236|Primary|Mu Suppression on EEG|This primary outcome measure is mu suppression recorded during a biological motion task. In this task, participants view point-light walker (PLW) animations of a human; the PLWs were either male or female, happy or sad, or walking towards or away from the viewer. In addition to the humans, there was a control condition which consisted of a circle moving either left or right. In separate blocks, participants had to identify either the gender, the emotion, or intention (i.e., direction) of the walker, or the direction of the circle, while their EEG was recorded. The primary measure was mu activity (8-12 Hz) recorded over 3 central electrodes. Mu suppression was calculated as the log10 transformed ratio of mu power to one of the three human conditions compared to the circle: log10(human/circle). A negative value indicates suppression of mu activity to human walkers vs. circles. We are presenting the mean (SD) of this suppression ratio collapsed over the 3 human conditions.|Baseline, 1 Week||||log10 transformed ratio (Hz)||Standard Deviation|Mean
2573188|NCT02497976|Secondary|Urgency Scale|Subjects rated their average urinary urgency or need to urinate using an 11-point numerical rating scale of 0-no urgency to 10-worse ever urgency|Value of Weeks 2, 4, 10, and 18 minus baseline||||units on a scale||Standard Deviation|Mean
2573189|NCT02497976|Secondary|Pain Scale|an 11-point pain intensity numerical rating scale. Subjects rated their average pain, pressure, or discomfort associated with their bladder using an 11-point pain intensity numerical rating scale of 0-no pain to 10-worse ever pain at baseline, and at weeks 2, 4, 10, and 18. Meaningful, clinically important pain relief is a reduction in pain of approximately 30% from baseline.|Value at Weeks 2, 4, 10, and 18 minus baseline||||units on a scale||Standard Deviation|Mean
2573190|NCT02497976|Secondary|IC/BPS Symptoms Assessment With the Interstitial Cystitis Problem Index (ICPI)|The Interstitial Cystitis Symptom Index (ICPI) is one of the two O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes. This scale has a 0 if the patient has no symptoms and a maximum of 16 with severe symptoms.|Value of Weeks 2, 4, 10, and 18 minus baseline||||units on a scale||Standard Deviation|Mean
2573191|NCT02497976|Secondary|IC/BPS Symptoms Assessment With the Interstitial Cystitis Symptom Index|The Interstitial Cystitis Symptom Index is one of the two O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes. This scale has a 0 if the patient has no symptoms and a maximum of 19 with severe symptoms. Lubeck et al. validated ICSI as a valid measure of change in treatment outcome studies. A change of -4.03 in the ICSI score was the same as a 2 point improvement in GRA. Propert et al. validated the ICSI as responsive to change in IC/BPS symptoms and was recommended as secondary endpoints in clinical trials. A change of -2.4 in the ICSI score was the same as a 2 point improvement in GRA.|Value at Weeks 2, 4, 10 and 18 minus Baseline||||units on a scale||Standard Deviation|Mean
2573192|NCT02497976|Secondary|IC/BPS Symptoms Change With Overall Global Response Assessment (GRA)|"Patient-reported global response assessment (GRA) such as Compared to when you began this trial, how would you rate your IC symptoms now? Study subjects reported their response to treatment of their pain, urgency, and overall status compared to their condition at trial start with a symmetric scale global response assessment (GRA) 28 at weeks 2, 4, 10, and 18. Possible responses were markedly worse (100% worse), moderately worse (50% worse), slightly worse (25% worse), no change (0% improvement), slightly improved (25% improvement), moderately improved (50% improvement), and markedly improved (100% improved). Treatment responders were defined by rating the GRA as moderately improved or markedly improved."|Week 4, 10, 18||||Participants|||Count of Participants
2573193|NCT02497976|Primary|IC/BPS Symptoms Change With Overall Global Response Assessment (GRA)|"Patient-reported global response assessment (GRA) such as Compared to when you began this trial, how would you rate your IC symptoms now? Study subjects reported their response to treatment of their pain, urgency, and overall status compared to their condition at trial start with a symmetric scale global response assessment (GRA) 28 at weeks 2, 4, 10, and 18. Possible responses were markedly worse (100% worse), moderately worse (50% worse), slightly worse (25% worse), no change (0% improvement), slightly improved (25% improvement), moderately improved (50% improvement), and markedly improved (100% improved). Treatment responders were defined by rating the GRA as moderately improved or markedly improved."|Week 2||||Participants|||Count of Participants
2573194|NCT02497937|Secondary|Elimination Half Life (T½) for GSK2798745|Blood samples for PK analysis were planned to be collected at pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8 and 12 hours on Day 1, pre-dose and at 12 hours post dose on Day 2, pre-dose on Days 3 to 6, Pre-dose, 0.5, 1, 1.5, 2, 3, 5 and 10 hours on Day 7 and at 24 and 48 hours on Days 8 and 9. T½ was defined as Elimination half life of drug. Data is not available for t1/2. The analysis was planned but not performed. PK sampling scheme was not adequate enough to reliably estimate the t1/2 of GSK2798745.|Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8 and 12 hours post-dose), Day 2 (pre-dose, 12 hours post-dose), Days 3 to 6 (pre-dose), Day 7 (Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 10, 24 and 48 hours post-dose)|PK Parameter Population. Data is not available for t1/2. The analysis was planned but not performed. PK sampling scheme was not adequate enough to reliably estimate the t1/2 of GSK2798745.||||||
2573195|NCT02497937|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) for GSK2798745|Blood samples for PK analysis were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8 and 12 hours on Day 1, pre-dose and at 12 hours post dose on Day 2, pre-dose on Days 3 to 6, Pre-dose, 0.5, 1, 1.5, 2, 3, 5 and 10 hours on Day 7 and at 24 and 48 hours on Days 8 and 9. Tmax was defined as time to maximum observed plasma concentration of drug.|Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8 and 12 hours post-dose), Day 2 (pre-dose, 12 hours post-dose), Days 3 to 6 (pre-dose), Day 7 (Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 10, 24 and 48 hours post-dose)|PK Parameter population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hour||Full Range|Median
2573196|NCT02497937|Secondary|Maximum Drug Concentration (Cmax) for GSK2798745|Blood samples for PK analysis were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8 and 12 hours on Day 1, pre-dose and at 12 hours post dose on Day 2, pre-dose on Days 3 to 6, Pre-dose, 0.5, 1, 1.5, 2, 3, 5 and 10 hours on Day 7 and at 24 and 48 hours on Days 8 and 9. Cmax was defined as maximum observed plasma concentration of drug.|Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8 and 12 hours post-dose), Day 2 (pre-dose, 12 hours post-dose), Days 3 to 6 (pre-dose), Day 7 (Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 10, 24 and 48 hours post-dose)|PK Parameter. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2573197|NCT02497937|Secondary|Area Under the Concentration Time Curve (AUC) Time Zero to the Last Time of the Last Quantifiable Concentration (AUC(0-t)), AUC Over the Dosing Interval After First and Last Dose (AUC(0-tau)) and AUCall for GSK2798745|AUC(0-t), AUC(0-tau) and AUCall for GSK2798745 were determined based on intensive Pharmacokinetic (PK) sampling at the following time points: Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8 and 12 hours on Day 1, pre-dose and at 12 hours post dose on Day 2, pre-dose on Days 3 to 6, Pre-dose, 0.5, 1, 1.5, 2, 3, 5 and 10 hours on Day 7 and at 24 and 48 hours. PK parameter population included all participants in the PK Concentration Population for whom valid and evaluable pharmacokinetic parameters were derived|Day 1 (Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8 and 12 hours post-dose), Day 2 (pre-dose, 12 hours post-dose), Days 3 to 6 (pre-dose), Day 7 (Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 10, 24 and 48 hours post-dose)|PK Parameter Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||hour*nanogram per mL||Geometric Coefficient of Variation|Geometric Mean
2573198|NCT02497937|Secondary|Change From Baseline in Participant Reported Health Status (SF-36) Acute Score|The SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best). Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from specified time point value.|Baseline and Day 7 of each treatment period|Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Score on a scale||Standard Deviation|Mean
2573199|NCT02497937|Secondary|Number of Participants With All Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AE and SAE are reported.|Up to Day 46|All Subjects Population.|||Participants|||Count of Participants
2573200|NCT02497937|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin|Blood samples were collected to analyze Mean Corpuscle Hemoglobin. Change from Baseline was presented for this parameter. Day -1 was Baseline and change from Baseline was calculated by subtracting the baseline value from specified time point value. NA indicates data was not available. Standard deviation could not be calculated as a single participant was analyzed at the specified time point|Baseline and up to Day 7 in each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Picograms||Standard Deviation|Mean
2573201|NCT02497937|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin Concentration|Blood samples were collected to analyze Mean Corpuscle Hemoglobin concentration . Change from Baseline is presented for this parameter. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from specified time point value. NA indicates data was not available. Standard deviation could not be calculated as a single participant was analyzed at the specified time point|Baseline and up to Day 7 in each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||grams per liter||Standard Deviation|Mean
2573202|NCT02497937|Secondary|Change From Baseline in Red Blood Cell Count (RBC) and Reticulocytes|Blood samples were collected to analyze the Hematology parameters including RBC and Reticulocytes. Change from Baseline is presented for these parameters. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from specified time point value.|Baseline and up to Day 7 in each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Trillion cells per liter||Standard Deviation|Mean
2573203|NCT02497937|Secondary|Change From Baseline in Mean Corpuscle Volume|Blood samples were collected to analyze Mean Corpuscle Volume. Change from Baseline is presented for this parameter. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from specified time point value.|Baseline and up to Day 7 in each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Femtoliters||Standard Deviation|Mean
2573204|NCT02497937|Secondary|Change From Baseline in Hemoglobin|Blood samples were collected to analyze Hemoglobin. Change from Baseline is presented for this parameter. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from specified time point value.|Baseline and up to Day 7 in each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Gram per liter||Standard Deviation|Mean
2573205|NCT02497937|Secondary|Change From Baseline in Hematocrit|Blood samples were collected to analyze the Hematology parameter Hematocrit. Change from Baseline is presented for this parameter. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from specified time point value.|Baseline and up to Day 7 in each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Proportion of red blood cells in blood||Standard Deviation|Mean
2574803|NCT02476448|Primary|Ureteral Jet Visibility|"Surgeons will chose from a likert scales as either:~not visible~Somewhat visible~clearly visible This will be completed during the cystoscopic evaluation"|5 minutes||||Participants|||Count of Participants
2573206|NCT02497937|Secondary|Change From Baseline in Hematology: Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, White Blood Cell (WBC) Count, Total Neutrophils|Blood samples were collected to analyze the Hematology parameters including Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet count, White Blood Cell (WBC) count, Total Neutrophils. Change from Baseline is presented for these parameters. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from specified time point value.|Baseline and up to Day 7 in each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Giga cells per liter||Standard Deviation|Mean
2573207|NCT02497937|Secondary|Change From Baseline in Chemistry: N-terminal Pro-Brain Natriuretic Peptide|Blood samples were collected to analyze the Chemistry parameter N-terminal pro-Brain Natriuretic Peptide. Change from Baseline is presented for these parameters. Day -1 was Baseline and change from Baseline is calculated by subtracting the baseline value from specified time point value.|Baseline and up to Day 7 in each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Nanograms per liter||Standard Deviation|Mean
2573208|NCT02497937|Secondary|Change From Baseline in Troponin I Levels and Type I Collagen Cross-linked C-telopeptide|Blood samples were collected to analyze the troponin I level and type I collagen cross-linked C-telopeptide (T1CCT). Change from Baseline was presented for these parameters. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from value at specified time point.|Baseline and up to Day 7 in each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Microgram per liter||Standard Deviation|Mean
2573209|NCT02497937|Secondary|Change From Baseline in Digoxin Level|Blood samples were collected to analyze the digoxin levels. Change from Baseline is presented for these parameters. Day -1 was Baseline and change from Baseline was calculated by subtracting the baseline value from specified time point value. NA indicates data not available. Standard deviation could not be calculated as a single participant was analyzed.|Baseline and up to Day 7 in each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Nanomoles per liter||Standard Deviation|Mean
2573210|NCT02497937|Secondary|Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, Uric Acid|Blood samples were collected to analyze the chemistry parameters including Creatinine, Direct Bilirubin, Total Bilirubin and Uric acid. Change from Baseline was presented for these parameters. Day -1 was Baseline and change from Baseline was calculated by subtracting the baseline value from specified time point value.|Baseline and up to Day 7 of each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2573211|NCT02497937|Secondary|Change From Baseline in Chemistry: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN)|Blood samples were collected to analyze the chemistry parameters including Calcium, Chloride, Glucose, Potassium, Sodium, Urea/BUN. Change from Baseline is presented for these parameters. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from specified time point value.|Baseline and up to Day 7 of each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2573212|NCT02497937|Secondary|Change From Baseline in Albumin and Total Protein Values|Blood samples were collected to analyze the chemistry parameters including albumin and total protein. Change from Baseline is presented for these parameters. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from value at specified time point.|Baseline and up to Day 7 of each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Grams per liter||Standard Deviation|Mean
2573213|NCT02497937|Secondary|Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase, Gamma Glutamyl Transferase (GGT) Values|Blood samples were collected to analyze the chemistry parameters including ALT, ALP, AST, creatine kinase and GGT. Change from Baseline is presented for these parameters. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from value at specified time point.|Baseline and up to Day 7 in each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||International units per liter||Standard Deviation|Mean
2573214|NCT02497937|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Triplicate 12-lead ECG was obtained using an automated ECG machine at Baseline (Day-1) and single ECG measurements (M) were taken on Day 4 and Day 7. Data for number of participants with abnormal-clinically significant (CS) and abnormal-not clinically significant (NCS) ECG data is presented.|Up to Day 7 in each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2573215|NCT02497937|Secondary|Change From Baseline in Percent Oxygen in Blood|Percent oxygen in blood was measured using pulse oximetry in a semi-supine position after 5 minutes rest at Baseline and up to 7 days of each treatment period. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from value at specified time point.|Baseline and up to Day 7 of each treatment period|All Subjects population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percentage of oxygen||Standard Deviation|Mean
2573216|NCT02497937|Secondary|Change From Baseline in Temperature|Body temperature was measured in a semi-supine position after 5 minutes rest at Baseline and up to 7 days of each treatment period. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from value at specified time point.|Baseline and up to Day 7 of each treatment period|All Subjects population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Celsius||Standard Deviation|Mean
2573217|NCT02497937|Secondary|Change From Baseline in Respiration Rate|Respiration rate was measured in a semi-supine position after 5 minutes rest at Baseline and up to 7 days of each treatment period. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from value at specified time point.|Baseline and up to Day 7 of each treatment period|All Subjects population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||breaths per minute||Standard Deviation|Mean
2573218|NCT02497937|Secondary|Change From Baseline in Heart Rate|Heart rate was measured in a semi-supine position after 5 minutes rest at Baseline and up to 7 days of each treatment period. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from value at specified time point.|Baseline and up to Day 7 of each treatment period|All Subjects population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||beats per minute||Standard Deviation|Mean
2573219|NCT02497937|Secondary|Change From Baseline in Systolic Blood Pressure(SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured in a semi-supine position after 5 minutes rest at Baseline and up to 7 days of each treatment period. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from specified time point value.|Baseline and up to Day 7 of each treatment period|All Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Millimeters of mercury||Standard Deviation|Mean
2573220|NCT02497937|Secondary|Respiratory Rate Over Time Continuously Measured by Body Sensor (Site: Mayo Only)|Continuous remote monitoring was performed during each 7-day study period utilizing the Preventice BodyGuardian Remote Monitoring System. Participants were instructed to wear the sensor throughout each study period. Respiratory monitoring data was collected in different body positions like standing, leaning, lying and unknown. Data is presented only for participants from Mayo clinic.|Up to Day 7 of each treatment period|All Subjects population comprised of all randomized participants who received at least one dose of study medication. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||breaths per minute||Standard Deviation|Mean
2573221|NCT02497937|Secondary|Change From Baseline in Dyspnea Score|Dyspnea was assessed using a standardized, validated 5-point Likert scale. Participants were asked to check the box next to the statement that most accurately described their current state of breathlessness or shortness of breath. Scale consisted of 5 points : 1- Not short of breath, 2- Mildly short of breath, 3- Moderately short of breath, 4- Severely short of breath and 5- Very severely short of breath. Participants rated their current state of breathlessness on this 5 point scale. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from value at specified time point .|Baseline, Day 5 and Day 7 of each treatment period|Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2573222|NCT02497937|Secondary|Change From Baseline in End-expiratory Lung Volume (EELV) Measured by Body Plethysmograph|EELV corresponds to FRC in the presence of positive end expiration pressure (PEEP). Analysis was planned but not performed. EELV parameter was not collected because other measures which were collected served as reasonable surrogates.|Baseline, Day 4 and Day 7 of each treatment period|Analysis Population. Analysis was planned but not performed. EELV parameter was not collected because other measures which were collected served as reasonable surrogates.||||||
2573223|NCT02497937|Secondary|Change From Baseline in Functional Residual Capacity (FRC)|FRC is the volume of air present in the lungs at the end of passive expiration. FRC was planned to be measured by body plethysmography. Analysis was planned but not performed. FRC parameter was not collected because other measures which were collected served as reasonable surrogates.|Baseline, Day 4 and Day 7 of each treatment period|Analysis Population. Analysis was planned but not performed. FRC parameter was not collected because other measures which were collected served as reasonable surrogates.||||||
2573224|NCT02497937|Secondary|Change From Baseline in Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 Second (FEV1), Forced Expiratory Flows (FEF) 25-75, FEF50 and FEF75|FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FVC is the total amount of air exhaled during the lung function test. FEF is the the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. FEF 25-75, FEF50 and FEF75 is defined as a reduction in forced expiratory flow at 25 to 75 percent of the pulmonary volume. Results presented combines data across all sites. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from value at specified time point.|Baseline, Day 4 and Day 7 of each treatment period|Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Liters||Standard Deviation|Mean
2573225|NCT02497937|Secondary|Change From Baseline in the Ventilation/Volume of Carbon Dioxide Production (VE/VCO2) Ratio|Participants were asked to participate in a submaximal exercise test that consisted of 3 parts: a 2-minute (min) resting Baseline, a 3-min step exercise and a 1-min recovery period. Throughout the test, breathing pattern, gas exchange, and heart rate were monitored using a simplified gas analysis system. Respiratory exchange ratio and the Borg Rating of Perceived Exertion measures were utilized to ensure participants perform progressive exercise while maintaining a submaximal level throughout the exercise period. Minute ventilation, breath frequency, tidal volume, oxygen consumption, carbon dioxide (CO2) production, Respiratory exchange ratio (RER) and end tidal CO2 were obtained from the breath-by-breath gas measurements. The VE/VCO2 slope and other variables were derived from this data. Day -1 was Baseline and change from Baseline was calculated by subtracting the Baseline value from value at specified time point.|Baseline and Day 7 of each treatment period|Analysis Population|||Ratio||Standard Deviation|Mean
2573272|NCT02497469|Primary|Percentage of Participants Who Achieved Clinical Remission|Clinical remission was defined as a complete Mayo score of ≤2 points and no individual subscore >1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).|Week 52|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2573226|NCT02497937|Secondary|Change From Baseline in DLco Following Exercise and Following an Intravenous Saline Infusion (Site: Hennepin)|DLco is a measure of the ability of a gas to transfer from the alveoli across the alveolar epithelium and the capillary endothelium to the red blood cells. Changes in DLco reflect the alveolar-capillary membrane conductance. Acute pulmonary congestion cause a reduction in DLco. In participants with heart failure, decrease in DLco serves as a predictor of disease progression. DLco was measured just prior to and after the 3- minute step test on Days -1, and 7 and just prior to and after an intravenous saline infusion on Day 5. Day -1 was Baseline and change from Baseline was calculated from Day -1 pre-Exercise of the respective period, except when calculating the post-infusion change from Baseline, where the pre-infusion value was used as the Baseline. Data for DLco following exercise and following an intravenous saline infusion is presented for Hennepin site is presented.|Baseline, Day 5 and Day 7 of each treatment period|Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||mL/mmHg/min||Standard Deviation|Mean
2573227|NCT02497937|Secondary|Change From Baseline in DLco Following Exercise and Following an Intravenous Saline Infusion (Site: Mayo)|DLco is a measure of the ability of a gas to transfer from the alveoli across the alveolar epithelium and the capillary endothelium to the red blood cells. Changes in DLco reflect the alveolar-capillary membrane conductance. Acute pulmonary congestion causes a reduction in DLco. In participants with heart failure, decrease in DLco serves as a predictor of disease progression. DLco was measured just prior to and after the 3- minute step test on Days -1, and 7 and just prior to and after an intravenous saline infusion on Day 5. Day -1 was Baseline and change from Baseline was calculated from Day -1 pre-exercise of the respective period, except when calculating the post-infusion change from Baseline, where the pre-infusion value was used as the Baseline. Data for DLco following exercise and following an intravenous saline infusion is presented for Mayo site.|Baseline, Day 5 and Day 7 of each treatment period|Analysis Population.|||mL/mmHg/min||Standard Deviation|Mean
2573228|NCT02497937|Secondary|Change From Baseline in Capillary Blood Volume (Vc)|Vc is defined as volume of blood within the capillaries. Day -1 was Baseline and change from Baseline was calculated from Day -1 pre-exercise of the respective period, except when calculating the post-infusion change from Baseline, where the pre-infusion value was used as the Baseline. The data is presented only for participants from the Mayo Clinic as the data was not collected at Hennepin.|Baseline, Day 4, Day 5 and Day 7 of each treatment period|Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||mL||Standard Deviation|Mean
2573229|NCT02497937|Secondary|Change From Baseline in Diffusing Capacity of the Lung for Nitric Oxide (DLno) and Membrane Conductance (DM)|DLno is a measure of the ability of a gas to transfer from the alveoli across the alveolar epithelium and the capillary endothelium to the red blood cells. Changes in DLco reflect the alveolar-capillary DM. Since nitric oxide has a greater affinity for hemoglobin, transfer of gas mainly limits the diffusion of nitric oxide across the alveolar capillary membrane. Day -1 was Baseline and change from Baseline was calculated from Day -1 pre-exercise of the respective period, except when calculating the post-infusion change from Baseline, where the pre-infusion value was used as Baseline. The data is presented only for participants from the Mayo Clinic as the data was not collected at Hennepin.|Baseline, Day 4, Day 5 and Day 7 of each treatment period|Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||mL/mmHg/min||Standard Deviation|Mean
2573230|NCT02497937|Primary|Change From Baseline in the Diffusing Capacity of the Lung for DLco on Pulmonary Gas Transfer (Site: Hennepin)|DLco is a measure of the ability of a gas to transfer from the alveoli across the alveolar epithelium and the capillary endothelium to the red blood cells. Changes in DLco reflect the alveolar-capillary membrane conductance. Acute pulmonary congestion cause a reduction in DLco. In participants with heart failure, decrease in DLco serves as a predictor of disease progression. An impairment in the diffusing capacity of the lung may be related to the symptoms and exercise intolerance associated with heart failure. DLco was measured just prior to and after the 3- minute step test on Days -1, and 7 and just prior to and after an intravenous saline infusion on Day 5. Day -1 was Baseline and change from Baseline was calculated from Day -1 Pre-Exercise of the respective period, except when calculating the post-infusion change from Baseline, where the pre-infusion value was used as the Baseline. Statistical analysis was not performed as the sample size was too small|Baseline, Day 4, Day 5 and Day 7 of each treatment period|Analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||mL/mmHg/min||Standard Deviation|Mean
2573231|NCT02497937|Primary|Change From Baseline in the Diffusing Capacity of the Lung for Carbon Monoxide (DLco) on Pulmonary Gas Transfer (Site: Mayo)|DLco is a measure of the ability of a gas to transfer from alveoli across the alveolar epithelium and capillary endothelium to the red blood cells. Changes in DLco reflect the alveolar-capillary membrane conductance. Acute pulmonary congestion causes a reduction in DLco. In participants with heart failure, decrease in DLco serves as a predictor of disease progression. An impairment in the diffusing capacity of the lung may be related to symptoms and exercise intolerance associated with heart failure. DLco was measured just prior to and after the 3- minute step test on Days -1, and 7 and just prior to and after an intravenous saline infusion on Day 5. Day -1 was Baseline and change from Baseline was calculated from Day -1 pre-exercise of the respective period, except when calculating the post-infusion change from Baseline, where the pre-infusion value was used as Baseline. Data of DLco (milliliter per millimeter of mercury per minute [mL/mmHg/min]) for Mayo site is presented.|Baseline, Day 4, Day 5 and Day 7 of each treatment period|Analysis Population comprised of participants in the ‘All Subjects’ population having Baseline and post-Baseline assessments of the endpoint of interest for both periods. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||mL/mmHg/min||Standard Deviation|Mean
2573273|NCT02497391|Primary|PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib||Predose on Day 1,and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 Hours Postdose|All participants who received at least 1 dose of study drug and had evaluable PK data.|||nanogram·hour/milliter (ng·h/mL)||Geometric Coefficient of Variation|Geometric Mean
2573320|NCT02496702|Secondary|Change From Baseline in Test Score of Line Walk at Week 14.|Number of steps a person can do on a line directly after the foot without touching outside the line. Baseline score compared to score at week 14.|Baseline and at week 14||||Steps||95% Confidence Interval|Mean
2573232|NCT02497781|Secondary|Percentage of Participants With Combined Response: Microbiologically Evaluable (ME) Analysis Population|Combined response was the combined assessment of clinical response and microbiological response. Favorable clinical response was defined as a clinical response of improvement and cure (at EOIV) and a clinical response of cure (at TOC). Cure defined as: resolution of all acute signs/symptoms of cUTI/improvement to such an extent that no further antimicrobial therapy required. Improvement defined as: participants who switched to oral therapy and had afebrile (temperature<=38.0°C) for >=24 hr; absence of new and improvement in at least 1 symptom or sign (ie, fever, pain, tenderness, elevated WBCs, elevated CRP) from Baseline and worsening of none. Favourable microbiological response was absence of the original baseline pathogen in source specimen. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).|EOIV visit (Day 4 to 15), TOC visit (up to a maximum study duration of 50 days)|ME analysis set: participants >=1gram(-ve) and no gram(+ve) pathogen (in urine) at baseline, confirmed cUTI diagnosis, had >=48hr IV study drug, unless discontinued due to AE, no important protocol deviation, concomitant antibiotic, >=1gram(-ve) typical UTI bacterial pathogen at Baseline susceptible to study drug and MR which was not indeterminate.|||percentage of participants|||Number
2573233|NCT02497781|Secondary|Percentage of Participants With Favourable Combined Response: Microbiological Intent-to-treat (Micro-ITT) Population|Combined response was the combined assessment of clinical response and microbiological response. Favorable clinical response was defined as a clinical response of improvement and cure (at EOIV) and a clinical response of cure (at TOC). Cure defined as: resolution of all acute signs/symptoms of cUTI/improvement to such an extent that no further antimicrobial therapy required. Improvement defined as: participants who switched to oral therapy and had afebrile (temperature<=38.0°C) for >=24 hr; absence of new and improvement in at least 1 symptom or sign (ie, fever, pain, tenderness, elevated WBCs, elevated CRP) from Baseline and worsening of none. Favourable microbiological response was absence of the original baseline pathogen in source specimen. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).|EOIV visit (Day 4 to 15), TOC visit (up to a maximum study duration of 50 days)|Micro-ITT analysis population included all randomized participants who had at least 1 gram negative typical pathogen (in the urine) at baseline known to cause cUTI and no gram cUTI and no gram positive pathogen (in the urine) at baseline.|||percentage of participants|||Number
2573234|NCT02497781|Secondary|Percentage of Participants With Emergent Infections: Microbiologically Evaluable (ME) Analysis Population|Emergent infections were categorized as super-infection and new infections. Superinfection: A urine culture identified pathogen other than a baseline pathogen during the course of active treatment with study therapy along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. New infection: A urine culture identified pathogen other than a baseline pathogen at any time after study treatment had finished along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. Percentage of participants with any (super infections or new infections) of the infections were reported.|Baseline up to 50 days|ME analysis set: participants >=1gram(-ve) and no gram(+ve) pathogen (in urine) at baseline, confirmed cUTI diagnosis, had >=48hr IV study drug, unless discontinued due to AE, no important protocol deviation, concomitant antibiotic, >=1gram(-ve) typical UTI bacterial pathogen at Baseline susceptible to study drug and MR which was not indeterminate.|||percentage of participants|||Number
2573235|NCT02497781|Secondary|Percentage of Participants With Emergent Infections: Microbiological Intent-to-treat (Micro-ITT) Population|Emergent infections were categorized as super-infection and new infections. Superinfection: A urine culture identified pathogen other than a baseline pathogen during the course of active treatment with study therapy along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. New infection: A urine culture identified pathogen other than a baseline pathogen at any time after study treatment had finished along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. Percentage of participants with any (super infections or new infections) of the infections were reported.|Baseline up to 50 days|Micro-ITT analysis population included all randomized participants who had at least 1 gram negative typical pathogen (in the urine) at baseline known to cause cUTI and no gram cUTI and no gram positive pathogen (in the urine) at baseline.|||percentage of participants|||Number
2573236|NCT02497781|Secondary|Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Microbiologically Evaluable (ME) Analysis Set at LFU|A participant was said to have clinical relapse if met either 1 of the following criteria: reappearance or worsening of signs and symptoms of cUTI that required further antimicrobial therapy and/or surgery, or death after TOC in which cUTI was contributory. LFU visit occurred within 20 to 36 days after last dose of study treatment (IV or oral).|LFU visit (anytime up to a maximum study duration of 50 days)|ME analysis set: participants >=1gram(-ve) and no gram(+ve) pathogen (in urine) at baseline, confirmed cUTI diagnosis, had >=48hr IV study drug, unless discontinued due to AE, no important protocol deviation, concomitant antibiotic, >=1gram(-ve) typical UTI bacterial pathogen at Baseline susceptible to study drug and MR which was not indeterminate.|||percentage of participants|||Number
2573237|NCT02497781|Secondary|Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Clinically Evaluable (CE) Analysis Set at LFU|A participant was said to have clinical relapse if met either 1 of the following criteria: reappearance or worsening of signs and symptoms of cUTI that required further antimicrobial therapy and/or surgery or death after TOC in which cUTI was contributory. LFU visit occurred within 20 to 36 days after last dose of study treatment (IV or oral).|LFU visit (anytime up to a maximum study duration of 50 days)|CE analysis set at LFU: participants >=1gram negative typical pathogen known to cause cUTI, no gram positive pathogen (in urine) at baseline, confirmed cUTI diagnosis, >=48hr of IV study drug, unless discontinued due to AE, no important protocol deviations, no concomitant antibiotic,were evaluated for clinical response of sustained cure or relapse.|||percentage of participants|||Number
2573274|NCT02497391|Primary|Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib||Predose on Day 1,and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 Hours Postdose|All participants who received at least 1 dose of study drug and had evaluable PK data.|||nangram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2574837|NCT02475980|Secondary|Follow-up Adherence|Proportion of girls who present for follow-up appointment after referral to Adolescent Gynecology outpatient clinic|4 weeks after enrollment|Number of participants given a referral to Adolescent Gynecology in PED|||participants|||Number
2573238|NCT02497781|Secondary|Percentage of Participants With Favourable Microbiological Response: Microbiologically Evaluable (ME) Analysis Population|Favourable microbiological response was achieved when all baseline pathogens were eradicated. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study if on oral switch therapy (which occurred within the maximum study treatment duration of 14 days).|EOIV visit (Day 4 to 15), EOT visit (up to Day 16)|ME analysis set: participants >=1gram(-ve) and no gram(+ve) pathogen (in urine) at baseline, confirmed cUTI diagnosis, had >=48hr IV study drug, unless discontinued due to AE, no important protocol deviation, concomitant antibiotic, >=1gram(-ve) typical UTI bacterial pathogen at Baseline susceptible to study drug and MR which was not indeterminate.|||percentage of participants|||Number
2573239|NCT02497781|Secondary|Percentage of Participants With Favourable Microbiological Response: Microbiological Intent-to-treat (Micro-ITT) Population|Favourable microbiological response was achieved when all baseline pathogens were eradicated. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study if on oral switch therapy (which occurred within the maximum study treatment duration of 14 days).|EOIV visit (Day 4 to 15), EOT visit(up to Day 16)|Micro-ITT analysis population included all randomized participants who had at least 1 gram negative typical pathogen (in the urine) at baseline known to cause cUTI and no gram cUTI and no gram positive pathogen (in the urine) at baseline.|||percentage of participants|||Number
2573240|NCT02497781|Secondary|Percentage of Participants With Favourable Clinical Response (CR): Microbiologically Evaluable (ME) Analysis Population|Favorable CR was defined as a CR of improvement and cure(at end of 72 hours(hr) and EOIV) and a CR of cure(at EOT and TOC).Cure is resolution of all acute signs/symptoms of cUTI/improvement to such an extent that no further antimicrobial therapy required.Improvement is:1)at end of 72hr study drug treatment: improvement but not enough to switch to oral therapy and still on IV study drug at end of 72hr and meet following criterion: Absence of new signs/symptoms, and improvement in at least 1 symptom/sign(ie, fever,pain,tenderness,elevated WBCs,elevated CRP) from Baseline,and with no worsening of any symptom/sign. 2) at EOIV: participants who switched to oral therapy and had afebrile(temperature<=38.0°C) for >=24hr;absence of new and improvement in at least 1 symptom/sign from Baseline and worsening of none.EOT visit occurred within 48hr after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study(if on oral switch therapy).|EOIV visit (anytime from Day 4 to 15), EOT visit (up to Day 16), TOC visit (up to a maximum study duration of 50 days)|ME analysis set: participants >=1gram(-ve) and no gram(+ve) pathogen (in urine) at baseline, confirmed cUTI diagnosis, had >=48hr IV study drug, unless discontinued due to AE, no important protocol deviation, concomitant antibiotic, >=1gram(-ve) typical UTI bacterial pathogen at Baseline susceptible to study drug and MR which was not indeterminate.|||percentage of participants||95% Confidence Interval|Number
2573241|NCT02497781|Secondary|Percentage of Participants With Favourable Clinical Response (CR) at TOC: Clinically Evaluable (CE) Analysis Set at TOC|Favourable clinical response was defined as resolution of all acute signs/symptoms of cUTIs or improvement to such an extent that no further antimicrobial therapy was needed. Participants who met the following criterion: Incomplete resolution or worsening of cUTI signs or symptoms or development of new signs or symptoms requiring alternative non-study antimicrobial therapy or death in which cUTI was contributory. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).|TOC visit (up to a maximum study duration of 50 days)|CE analysis set at TOC: participants >=1 gram negative typical pathogen known to cause cUTI, no gram positive pathogen (in urine) at baseline, confirmed cUTI diagnosis, >=48hr of IV study drug, unless discontinued due to AE, no important protocol deviations, no concomitant antibiotic, had clinical response of cure, improvement or failure at TOC.|||percentage of participants||95% Confidence Interval|Number
2573242|NCT02497781|Secondary|Percentage of Participants With Favourable Clinical Response (CR) at End of Treatment (EOT) Visit: Clinically Evaluable (CE) Analysis Set at EOT|Favourable clinical response was defined as a CR cure. Cure was defined as resolution of all acute signs and symptoms of complicated urinary tract infections (cUTIs) or improvement to such an extent that no further antimicrobial therapy was required. EOT visit occurred within 48hr after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study(if on oral switch therapy).|EOT visit (up to Day 16)|CE analysis set at EOT: participants >=1 gram negative typical pathogen known to cause cUTI, no gram positive pathogen (in urine) at baseline, confirmed cUTI diagnosis, >=48hr of IV study drug, unless discontinued due to AE, no important protocol deviations, no concomitant antibiotic, had clinical response of cure, improvement or failure at EOT.|||percentage of participants||95% Confidence Interval|Number
2573243|NCT02497781|Secondary|Percentage of Participants With Favourable Clinical Response (CR) at End of Intravenous Treatment (EOIV) Visit: Clinically Evaluable (CE) Analysis Set at EOIV|Favourable clinical response was defined as a CR of improvement and cure. Cure was defined as resolution of all acute signs and symptoms of complicated urinary tract infections (cUTIs) or improvement to such an extent that no further antimicrobial therapy was required. Clinical Improvement included all the participants who had switched to oral therapy and had meet the following criterion: afebrile (temperature <=38.0°C) for at least 24 hours, absence of new and improvement in at least 1 symptom or sign (fever, pain, tenderness, elevated WBCs, elevated c-reactive-protein) from baseline and worsening of none. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|EOIV visit (anytime from Day 4 to 15)|CE analysis set at EOIV: participants >=1 gram negative typical pathogen known to cause cUTI, no gram positive pathogen (in urine) at baseline, confirmed cUTI diagnosis, >=48 h of IV study drug, unless discontinued due to AE, no important protocol deviations, no concomitant antibiotic, had clinical response of cure, improvement or failure at EOIV.|||percentage of participants||95% Confidence Interval|Number
2573275|NCT02497287|Secondary|Percentage of Participants With Treatment-Emergent Acute Hypertension (Systolic and Diastolic) During IND and OP/MA Phases|Percentage of participants with treatment-emergent acute hypertension (Systolic Blood Pressure >=180 millimeters of mercury [mm Hg] or Diastolic Blood Pressure >= 110 mm Hg) during IND and OP/MA Phases were evaluated.|Up to End of OP/MA phase (Week 52)|All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant.|||Percentage of participants|||Number
2573244|NCT02497781|Secondary|Percentage of Participants With Favourable Clinical Response (CR) at End of 72 Hours Treatment: Clinically Evaluable (CE) Analysis Set at 72 Hours|Favourable clinical response was defined as a CR of improvement and cure. Cure was defined as resolution of all acute signs and symptoms of complicated urinary tract infections (cUTIs) or improvement to such an extent that no further antimicrobial therapy was required. Clinical Improvement included all the participants who had improvement but not enough to switch to oral therapy and were still on IV study drug at End of 72 hours and had meet the following criterion: absence of new signs and symptoms, and improvement in at least 1 symptom or sign (fever, pain, tenderness, elevated WBCs, elevated CRP) from baseline, and with no worsening of any symptom or sign.|End of 72 hours study drug treatment on Day 1|CE analysis set at 72hr: participants who had at least 1 gram negative typical pathogen (in urine) at baseline known to cause cUTI, no gram positive pathogen (in urine) at baseline, confirmed diagnosis of cUTI, >=48hr of IV study drug, unless discontinued due to treatment-limiting AE, no important protocol deviations and no concomitant antibiotics.|||percentage of participants||95% Confidence Interval|Number
2573245|NCT02497781|Secondary|Percentage of Participants With Favourable Clinical Response (CR): Microbiological ITT (Micro-ITT) Analysis Population|Favorable CR was defined as a CR of improvement and cure(at end of 72 hours(hr) and EOIV) and a CR of cure(at EOT and TOC).Cure is resolution of all acute signs/symptoms of cUTI/improvement to such an extent that no further antimicrobial therapy required.Improvement is:1)at end of 72hr study drug treatment: improvement but not enough to switch to oral therapy and still on IV study drug at end of 72hr and meet following criterion: Absence of new signs/symptoms, and improvement in at least 1 symptom/sign(ie, fever,pain,tenderness,elevated WBCs,elevated CRP) from Baseline,and with no worsening of any symptom/sign. 2) at EOIV: participants who switched to oral therapy and had afebrile(temperature<=38.0°C) for >=24hr;absence of new and improvement in at least 1 symptom/sign from Baseline and worsening of none.EOT visit occurred within 48hr after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study(if on oral switch therapy).|End of 72 hours study drug treatment, EOIV visit (anytime from Day 4 to 15), EOT visit (up to Day 16), TOC visit (up to a maximum study duration of 50 days)|Micro-ITT analysis population included all randomized participants who had at least 1 gram negative typical pathogen (in the urine) at baseline known to cause cUTI and no gram positive pathogen (in the urine) at baseline.|||percentage of participants||95% Confidence Interval|Number
2573246|NCT02497781|Secondary|Percentage of Participants With Favourable Clinical Response (CR): Intent-to-treat (ITT) Analysis Population|Favorable CR was defined as a CR of improvement and cure(at end of 72 hours(hr) and EOIV) and a CR of cure(at EOT and TOC).Cure is resolution of all acute signs/symptoms of cUTI/improvement to such an extent that no further antimicrobial therapy required.Improvement is:1)at end of 72hr study drug treatment: improvement but not enough to switch to oral therapy and still on IV study drug at end of 72hr and meet following criterion: Absence of new signs/symptoms, and improvement in at least 1 symptom/sign(ie, fever,pain,tenderness,elevated WBCs,elevated CRP) from Baseline,and with no worsening of any symptom/sign. 2) at EOIV: participants who switched to oral therapy and had afebrile(temperature<=38.0°C) for >=24hr;absence of new and improvement in at least 1 symptom/sign from Baseline and worsening of none.EOT visit occurred within 48hr after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study(if on oral switch therapy).|End of 72 hours study drug treatment, EOIV visit (anytime from Day 4 to 15), EOT visit (up to Day 16), TOC visit (up to a maximum study duration of 50 days)|ITT analysis population included all participants who had been assigned a randomized treatment.|||percentage of participants||95% Confidence Interval|Number
2573247|NCT02497781|Secondary|Plasma Concentrations of Ceftazidime and Avibactam||15, 30-90, 300-360 minutes post-dose on Day 3|PK analysis set included all randomized participants who received any amount of CAZ-AVI and had at least 1 CAZ and/ or AVI plasma measurement available. This outcome measure was not planned to be analyzed for Cefepime receiving cohort, as pre-specified in protocol.|||nanogram per milliliter||Standard Deviation|Geometric Mean
2573248|NCT02497781|Primary|Percentage of Participants With Creatinine Clearance (CrCl) at Test of Cure (TOC) Visit|CrCl is a measure of glomerular filtration rate (GMFR), an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).|TOC visit (up to a maximum study duration of 50 days)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||percentage of participants|||Number
2573249|NCT02497781|Primary|Percentage of Participants With Creatinine Clearance (CrCl) at End of Intravenous Treatment (EOIV) Visit|CrCl is a measure of glomerular filtration rate (GMFR), an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|EOIV visit (anytime from Day 4 to 15)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||percentage of participants|||Number
2573250|NCT02497781|Primary|Percentage of Participants With Creatinine Clearance (CrCl) at Day 7|CrCl is a measure of glomerular filtration rate (GMFR), an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2.|Day 7|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||percentage of participants|||Number
2573321|NCT02496702|Primary|Change From Baseline in Test Score of 8-Foot Up-and-Go at Week 14.|Number of seconds required to get up from a seated position, walk 8 feet (2.44 meters), turn, and return to seated position. Baseline score compared to score at week 14.|Baseline and at week 14||||seconds||95% Confidence Interval|Mean
2573322|NCT02496702|Primary|Change From Baseline in Test Score of 30-second Chair Stand at Week 14.|Number of full stands that can be completed in 30 seconds with arms folded across chest. Baseline score compared to score at week 14.|Baseline and at week 14||||Full chair stands per 30 seconds||95% Confidence Interval|Mean
2573251|NCT02497781|Primary|Percentage of Participants With Potentially Clinically Significant Abnormalities in Electrocardiogram (ECG) Parameters|PCS criteria for abnormal value of ECG parameters: QT interval >=450 milliseconds (msec); 480 msec; >=500 msec; Increase from baseline (IFB) of >=30 msec; >=60 msec and >90 msec; Decrease from baseline (DFB) of >=30 msec; >=60 msec and >90 msec. QT interval using Bazett's correction (QTcB): >=450 milliseconds (msec); 480 msec; >=500 msec; Increase from baseline (IFB) of >=30 msec; >=60 msec and >90 msec; DFB of >=30 msec; >=60 msec and >90 msec. QT interval using Fridericia's correction (QTcF): >=450 msec; 480 msec; >=500 msec; IFB of >=30 msec; >=60 msec and >90 msec; DFB of >=30 msec; >=60 msec and >90 msec. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline until the EOIV visit (anytime from Day 4 to 15)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||percentage of participants|||Number
2573252|NCT02497781|Primary|Percentage of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters|Criteria for potentially clinically significant laboratory abnormalities: hematology (platelets: <0.4*lower limit of normal [LLN], >2*upper limit of normal [ULN], >40% decrease from baseline [DFB],>100% Increase from baseline [IFB]; Chemistry (Bicarbonate: <0.7*LLN, >1.3*ULN, >50% DFB, >30% IFB).|Baseline until the LFU visit (up to a maximum study duration of 50 days)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime). Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2573253|NCT02497781|Primary|Change From Baseline in Body Weight at End of Intravenous Treatment (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 to 15)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||kilogram||Standard Deviation|Mean
2573254|NCT02497781|Primary|Percentage of Participants With Abnormal Physical Examination Findings at End of Intravenous Treatment (EOIV) Visit|Physical examination included an assessment of the following: general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, thyroid, respiratory system, cardiovascular system, abdomen, musculoskeletal system (including spine and extremities), and neurological system. Participants with new or aggravated abnormal physical examination findings with regard to baseline findings were reported. Abnormality in physical examinations were based on blinded observer's discretion. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|EOIV visit (anytime from Day 4 to 15)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||percentage of participants|||Number
2573255|NCT02497781|Primary|Change From Baseline in Body Temperature at End of Intravenous Treatment (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 to 15)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime). Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||degree Celsius||Standard Deviation|Mean
2573256|NCT02497781|Primary|Change From Baseline in Respiratory Rate at End of Intravenous Treatment (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 to 15)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||breaths per minute||Standard Deviation|Mean
2573257|NCT02497781|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End of Intravenous Treatment (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 to 15)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2573258|NCT02497781|Primary|Change From Baseline in Pulse Rate at End of Intravenous Treatment (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 to 15)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||beats per minute||Standard Deviation|Mean
2573259|NCT02497781|Primary|Percentage of Participants With Cephalosporin Class Effects and Additional Adverse Events (AEs)|Percentage of participants with Cephalosporin class effects (defined as adverse event of special interest (AEoSI) within the safety topics (ST) of hypersensitivity/anaphylaxis) and additional AEs (which included AEs of diarrhea, renal disorder, hematological disorder and liver disorder relevant to the cephalosporin class within the safety topics (ST) based on MedDRA 20.0) were reported in this outcome measure.|Baseline until the LFU visit (up to a maximum study duration of 50 days)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||percentage of participants|||Number
2573260|NCT02497781|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between first dose of study drug and up to late follow-up (LFU) visit (20 to 36 days after last dose of study treatment [IV or oral]) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE.|Baseline until the LFU visit (up to a maximum study duration of 50 days)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI or Cefepime).|||percentage of participants|||Number
2573261|NCT02497755|Secondary|Care Process Measures as Measured by the Number and Type of Contacts With Care Manager.|The mean number of Follow-Up contacts between patient and care manager during the 8 weeks following the patient's activation of the app. (Other types of contacts with the care manager include Initial Assessment and Contact Attempt, but neither of these occurred during the time frame of app use.)|Eight weeks after intervention started||||number of contacts||Full Range|Mean
2573262|NCT02497755|Secondary|Care Team Communication as Measured by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) - Communication Scale|The mean total of patient app users' responses to the 6 items in the Consumer Assessment of Healthcare Providers and Systems (CAHPS) - Communication scale, with a mean score of 0-5 indicating that participants never or almost never experienced good communication with their care team, 6-11 indicating that participants sometimes experienced good communication with their care team, 12-17 indicating that patients usually experienced good communication with their care teams, and a score of 24 indicating that patients always experienced good communication with their care team.|Weeks 4 and 8|Only 13 participants were analyzed at the 8 week point because only 13 participants of the 17 completed the Week 8 survey.|||units on a scale||Full Range|Mean
2573263|NCT02497755|Secondary|Patient Use of the App as Measured by Percentage of App Surveys Completed.|The mean percentage of surveys presented to users through the app that were completed by patient app users in their first 8 weeks of using the app. App survey questions included weekly PHQ-9 and GAD-7 scales and daily measures of mood and medication use as well as satisfaction surveys.|Eight weeks after intervention started||||Percentage of surveys completed||Full Range|Mean
2573264|NCT02497755|Secondary|Patient Satisfaction as Measured by the Ginger.io Product Feedback Survey.|The mean total of patient app users' responses to the Ginger.io product feedback survey, with a mean score of 7-21 indicating satisfaction with the app, 22-34 neutrality, and 35-49 expressing dissatisfaction.|Days 30, 56|Overall Number of Participants Analyzed (13) is not consistent with numbers provided in the Participant Flow model (17) because 4 of the participants did not complete the Day 30 or the Day 56 survey. Only 2 participants were analyzed at the 56 day point because only 2 participants completed the Day 56 survey.|||units on a scale||Full Range|Mean
2573265|NCT02497755|Secondary|Technology Acceptability as Measured by the Obtrusiveness Scale for Pervasive Technology (Modified)|The mean total of patient app users' responses to the modified version of the Obtrusiveness Scale for Pervasive Technology, with a mean score of 13-39 indicating that the app is generally perceived as unacceptable/obtrusive, 40-64 indicating neutrality, and 65-91 indicating that the app is generally perceived as acceptable/unobtrusive.|During weeks 3 and 8|Only 3 participants were analyzed at the 8 week point because only 3 participants of the 17 completed the Week 8 survey.|||units on a scale||Full Range|Mean
2573266|NCT02497755|Primary|App Usefulness as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard as Useful|The number of care managers who expressed that the app was useful to them with regard to clinical workflow in a qualitative interview.|8-16 weeks after final patient participant is enrolled||||Participants|||Count of Participants
2573267|NCT02497755|Primary|App Usefulness as Measured by Number of Patient App Users Who Rate App as Useful|"The number of patients who rated the app as useful to them when asked about app usefulness in a qualitative interview and via a quantitative survey. Specific survey items included This technology is useful. All patients who expressed agreement (Somewhat Agree, Agree, or Strongly Agree) to this items and to similar questions in the qualitative interview were included in the count of patients who found the app acceptable."|Four weeks after intervention started|Overall Number of Participants Analyzed (16) is not consistent with numbers provided in the Participant Flow model (17) because one participant did not complete the quantitative survey used in this analysis.|||Participants|||Count of Participants
2573268|NCT02497755|Primary|App Acceptability as Measured by Number of Care Manager Dashboard Users Who Rate Dashboard Easy to Use and Time Spent Reasonable|The number of care managers who agreed that the app dashboard was easy to use and that the amount of time spent using the app dashboard was reasonable when asked about app acceptability and benefit vs. burden of use with regard to clinical workflow in a qualitative interview.|8-16 weeks after final patient participant is enrolled||||Participants|||Count of Participants
2573269|NCT02497755|Primary|App Acceptability as Measured by Number of Patient App Users Who Rate App Easy to Use and Time Spent Reasonable|"The number of patients who rated the app was easy to use and the amount of time spent using the app as reasonable when asked about app acceptability in a qualitative interview and via a quantitative survey. Specific survey items included The technology requires little effort to use, The technology was easy to learn how to use, The Ginger.io app is easy to use, and The time required to answer questions in the Ginger.io app is reasonable. All patients who expressed agreement (Somewhat Agree, Agree, or Strongly Agree) to these items and to similar questions in the qualitative interview were included in the count of patients who found the app acceptable."|Four weeks after intervention started|Overall Number of Participants Analyzed (16) is not consistent with numbers provided in the Participant Flow model (17) because one participant did not complete the quantitative survey used in this analysis.|||Participants|||Count of Participants
2573270|NCT02497469|Secondary|Percentage of Participants Who Used Oral Corticosteroids at Baseline Who Discontinued Corticosteroids and Were in Clinical Remission|Corticosteroid-free remission was defined as participants using oral corticosteroids at Baseline (Week 0) who had discontinued oral corticosteroids and were in clinical remission at Week 52. Clinical remission was defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).|Week 52|Particiopants from, FAS, included all randomized participants who received at least 1 dose of study drug who used who used oral corticosteroids at Baseline.|||percentage of participants||95% Confidence Interval|Number
2573271|NCT02497469|Secondary|Percentage of Participants Who Achieved Mucosal Healing|Mucosal healing was defined as a Mayo score endoscopic subscore of <= 1 point. The Mayo score was a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consisted of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore was scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).|Week 52|FAS included all randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2573323|NCT02496702|Primary|Change From Baseline in Test Score of 6 Minute Walking Test at Week 14.|Numbers of meters that can be walked in 6 minutes around a 50-yard (45.7 meters) course. Baseline score compared to score at week 14.|Baseline and at week 14||||m||95% Confidence Interval|Mean
2573276|NCT02497287|Secondary|Percentage of Participants With an Increase Score From Predose at Any Time in CADSS Total Score During OP/MA Phase|"The CADSS used to measure present-state dissociative symptoms, and to assess treatment-emergent dissociative symptoms. It comprises 23 subjective items divided into 3 components: depersonalization (with score range from 0 to 28), derealization (with score range from 0 to 52), and amnesia (with score range from 0 to 8). Participants responses are coded on a 5-point scale (0 = Not at all, 1 = Mild, 2 = Moderate, 3 = 'Severe and 4 = Extreme). The total score is sum of the 23 items and range from 0 to 92, where 0 (best) and 92 (worst). A higher score indicates a more severe condition."|Predose, up to 1.5 hours postdose (up to end of OP/MA phase [Week 52])|The full (OP/MA) analysis set included all participants who received at least 1 dose of intranasal study medication or 1 dose of oral antidepressant in the OP/MA phase.|||Percentage of participants|||Number
2573277|NCT02497287|Secondary|Percentage of Participants With an Increase Score From Predose at Any Time in Clinician-Administered Dissociative States Scale (CADSS) Total Score During IND Phase|"The CADSS used to measure present-state dissociative symptoms, and to assess treatment-emergent dissociative symptoms. It comprises 23 subjective items divided into 3 components: depersonalization (with score range from 0 to 28), derealization (with score range from 0 to 52), and amnesia (with score range from 0 to 8). Participants responses are coded on a 5-point scale (0 = Not at all, 1 = Mild, 2 = Moderate, 3 = 'Severe and 4 = Extreme). The total score is sum of the 23 items and range from 0 to 92, where 0 (best) and 92 (worst). A higher score indicates a more severe condition."|Predose, up to 1.5 hours postdose (up to end of IND phase [Week 4])|The full (IND) analysis set included all participants who received at least 1 dose of intranasal study medication or 1 dose of oral AD in open-label IND phase (for direct-entry and transferred-entry non-responder participants). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
2573278|NCT02497287|Secondary|Percentage of Participants With Remission as Assessed by PHQ-9 Total Score During IND Phase|"Remission is defined as PHQ-9 total score <= 4. PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. The scores are summed for a total score ranging from 0-27. A higher score indicates greater severity of depression. severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint."|Day 15 and Endpoint (last post-baseline assessment value during 4 weeks of IND phase)|The full (IND) analysis set included all participants who received at least 1 dose of intranasal study medication or 1 dose of oral antidepressant in the open-label IND phase (for direct-entry and transferred-entry non-responder participants). Here, 'n' signifies those participants who were evaluable at specific time point for this outcome measure.|||Percentage of participants|||Number
2573279|NCT02497287|Secondary|Percentage of Participants With Remission as Assessed by MADRS Total Score During IND Phase|"Remission is defined as MADRS total score less than or equal to (<=) 12. MADRS measures depression severity, detects changes due to AD treatment. It consists 10 items (evaluate apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores indicate more severe condition. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint."|Days 8, 15, 22 and Endpoint (last post-baseline assessment value during 4 weeks of IND Phase)|The full (IND) analysis set included all participants who received at least 1 dose of intranasal study medication or 1 dose of oral antidepressant in the open-label IND phase (for direct-entry and transferred-entry non-responder participants). Here, 'n' signifies those participants who were evaluable at specific time point for this outcome measure.|||Percentage of participants|||Number
2573280|NCT02497287|Secondary|Percentage of Participants With Response as Assessed by PHQ-9 Total Score During IND Phase|"Response is defined as >= 50 % reduction from baseline (IND phase) in PHQ-9 total score. PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. The scores are summed for a total score ranging from 0-27. A higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint."|Day 15 and Endpoint (last post-baseline assessment value during 4 Week IND phase)|The full (IND) analysis set included all participants who received at least 1 dose of intranasal study medication or 1 dose of oral antidepressant in the open-label IND phase (for direct-entry and transferred-entry non-responder participants). Here, 'n' signifies those participants who were evaluable at specific time point for this outcome measure.|||Percentage of participants|||Number
2573281|NCT02497287|Secondary|Percentage of Participants With Response as Assessed by MADRS Total Score During IND Phase|"Response is defined as greater than or equal to (>=) 50 % reduction from baseline in the MADRS total score. MADRS measures depression severity, detects changes due to AD treatment. It consists 10 items (evaluate apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores indicate more severe condition. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint."|Days 8, 15, 22 and Endpoint (last post-baseline assessment during 4 weeks of IND phase)|The full (IND) analysis set included all participants who received at least 1 dose of intranasal study medication or 1 dose of oral antidepressant in the open-label IND phase (for direct-entry and transferred-entry non-responder participants). Here, 'n' signifies those participants who were evaluable at specific time point for this endpoint.|||Percentage of participants|||Number
2573282|NCT02497287|Secondary|Change From Baseline in Sheehan Disability Scale Total Score During OP/MA Phase|"SDS was a participant-reported outcome measure and was a 5 item questionnaire used for assessment of functional impairment and associated disability. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0 to 10 rating scale. The score for the first three items are summed to create a total score of 0 to 30 where a higher score indicates greater impairment and a negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint."|Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)|The full (OP/MA) analysis set included all participants who received at least 1 dose of intranasal study medication or 1 dose of oral antidepressant in the OP/MA phase. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a Scale||Standard Deviation|Mean
2573283|NCT02497287|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score During IND Phase|"SDS was a 5 item questionnaire used for assessment of functional impairment and associated disability. The first three items assess disruption of (1) work/school, (2) social life, (3) family life/home responsibilities using a 0 to 10 rating scale. Score for the first three items are summed to create a total score of 0 to 30, higher score indicates greater impairment and a negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint."|Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND Phase)|Full (IND) analysis set: All participants who received at least 1 dose of intranasal study medication or 1 dose of oral antidepressant in the open-label IND phase (for direct-entry and transferred-entry non-responder participants). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a Scale||Standard Deviation|Mean
2573284|NCT02497287|Secondary|Change From Baseline to Endpoint in EQ-5D-5L Scale Score During OP/MA Phase: Health Status Index|"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health)."|Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)|The full (OP/MA) analysis set included all participants who received at least 1 dose of intranasal study drug or 1 dose of oral AD in OP/MA phase.|||Units on a Scale||Standard Deviation|Mean
2573285|NCT02497287|Secondary|Change From Baseline to Endpoint in EQ-5D-5L Score During OP/MA Phase: EQ-VAS|EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine).|Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)|The full (OP/MA) analysis set included all participants who received at least 1 dose of intranasal study drug or 1 dose of oral AD in OP/MA phase.|||Units on a Scale||Standard Deviation|Mean
2573286|NCT02497287|Secondary|Change From Baseline to Endpoint in European Quality of Life (EuroQol) 5-Dimension, 5-Level (EQ 5D-5L) During OP/MA Phase: Sum Score|"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state."|Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)|The full (OP/MA) analysis set included all participants who received at least 1 dose of intranasal study drug or 1 dose of oral AD in OP/MA phase.|||Units on a Scale||Standard Deviation|Mean
2573287|NCT02497287|Secondary|Change From Baseline to Endpoint in EQ-5D-5L Scale Score During IND Phase: Health Status Index|"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health)."|Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)|The full (IND) analysis set included all participants who received at least 1 dose of intranasal study drug or 1 dose of oral AD in the open-label IND phase (direct-entry, transferred-entry non-responder participants). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a Scale||Standard Deviation|Mean
2573288|NCT02497287|Secondary|Change From Baseline to Endpoint in EQ-5D-5L Score During IND Phase: EQ-VAS|EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine).|Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)|The full (IND) analysis set included all participants who received at least 1 dose of intranasal study drug or 1 dose of oral AD in the open-label IND phase (direct-entry, transferred-entry non-responder participants). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a Scale||Standard Deviation|Mean
2573324|NCT02496533|Secondary|Change in Pulse Rate|A trained clinician will measure and record the subject's radial pulse rate using standard practices.|Baseline and After Imaging|All patients completing the study per protocol were included in the analysis.|||beats per minute||Standard Deviation|Mean
2573289|NCT02497287|Secondary|Change From Baseline to Endpoint in European Quality of Life (EuroQol) 5-Dimension, 5-Level (EQ 5D-5L) During IND Phase: Sum Score|"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state."|Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)|The full (IND) analysis set included all participants who received at least 1 dose of intranasal study drug or 1 dose of oral AD in the open-label IND phase (direct-entry, transferred-entry non-responder participants). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a Scale||Standard Deviation|Mean
2573290|NCT02497287|Secondary|Change From Baseline to Endpoint in GAD-7 Total Score During OP/MA Phase|"GAD-7 is brief and validated 7-item self-reported assessment of overall anxiety. Participants respond to each item using a 4 point scale with response categories: 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score ranges from 0 to 21, higher scores indicate more anxiety. Negative change in score indicates improvement. Severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14), Severe (15 -21). Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint."|Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)|Full (OP/MA) analysis set: All participants who received at least 1 dose of intranasal study medication or 1 dose of oral antidepressant in the OP/MA phase. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a Scale||Standard Deviation|Mean
2573291|NCT02497287|Secondary|Change From Baseline to Endpoint in Generalized Anxiety Disorder (GAD-7) Total Score During IND Phase|"GAD-7 is brief, validated 7-item self-reported assessment of overall anxiety. Participant's responded to each item using a 4 point scale with response categories: 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield total score ranges from 0 to 21, higher scores indicate more anxiety. Negative change in score indicates improvement. Severity of GAD-7 is categorized as: None (0-4), Mild (5-9), Moderate (10-14), Severe (15 -21). Missing data was imputed using LOCF method, last post baseline observation during the phase was carried forward as Endpoint."|Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)|The full (IND) analysis set included all participants who received at least 1 dose of intranasal study drug or 1 dose of oral AD in the open-label IND phase (for direct-entry and transferred-entry non-responder participants). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a Scale||Standard Deviation|Mean
2573292|NCT02497287|Secondary|Change From Baseline to Endpoint in CGI-S Scale Score During OP/MA Phase|"The CGI-S measures the severity of the participant's illness that include knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7, where 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint."|Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)|The full (OP/MA) analysis set included all participants who received at least 1 dose of intranasal study medication or 1 dose of oral antidepressant in the OP/MA phase.|||Units on a Scale||Full Range|Median
2573293|NCT02497287|Secondary|Change From Baseline to Endpoint in Clinical Global Impression of Severity (CGI-S) Scale Score During IND Phase|"CGI-S measures severity of participant's illness that include knowledge of participant's history, psychosocial circumstances, symptoms, behavior, impact of symptoms on participant's ability to function. CGI-S evaluates severity of psychopathology on a scale range from 0 - 7, where 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as Endpoint."|Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)|Full (IND) analysis set: All participants who received at least 1 dose of intranasal study medication or 1 dose of oral AD in the open-label IND phase (for direct-entry and transferred-entry non-responder participants). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a Scale||Full Range|Median
2573294|NCT02497287|Secondary|Change From Baseline to Endpoint in PHQ-9 Total Score During OP/MA Phase|"PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. A higher score indicates greater severity of depression. severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint."|Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)|Full (OP/MA) analysis set: All participants who received at least 1 dose of intranasal study medication or 1 dose of oral antidepressant in the OP/MA phase.|||Units on a Scale||Standard Deviation|Mean
2573325|NCT02496533|Secondary|Change in Respiration Rate in Breaths Per Minute|A trained clinician will measure and record the subject's respiration rate using standard practices.|Baseline and After Imaging|All patients completing the study per protocol were included in the analysis.|||breaths per minute||Standard Deviation|Mean
2573295|NCT02497287|Secondary|Change From Baseline to Endpoint in Patient Health Questionnaire - 9 (PHQ-9) Total Score During IND Phase|"PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. A higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint."|Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)|Full (IND) analysis set: All participants who received at least 1 dose of intranasal study medication or 1 dose of oral antidepressant in the open-label IND phase (for direct-entry and transferred-entry non-responder participants). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Unit on a Scale||Standard Deviation|Mean
2573296|NCT02497287|Secondary|Change From Baseline to Endpoint in MADRS Total Score During Optimization/Maintenance (OP/MA) Phase|"MADRS measure depression severity, detects changes due to AD treatment. It evaluates 10 items: apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts, each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores represent a more severe condition. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint."|Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)|Full (OP/MA) analysis set: All participants who received at least 1 dose of intranasal study medication or 1 dose of oral AD in the OP/MA phase.|||Units on a Scale||Standard Deviation|Mean
2573297|NCT02497287|Secondary|Change From Baseline to Endpoint in Montgomery Asberg Depression Rating Scale (MADRS) Total Score During Induction (IND) Phase|"MADRS measures depression severity, detects changes due to AD treatment. It consists 10 items (evaluate apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores indicate more severe condition. Negative change in score indicates improvement. Missing data was imputed using last observation carried forward (LOCF) method, last post baseline observation during the phase was carried forward as the Endpoint."|Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)|The full (IND) analysis set included all participants who received at least 1 dose of intranasal study medication or 1 dose of oral AD in open-label IND phase (for direct-entry and transferred-entry non-responder participants). Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a Scale||Standard Deviation|Mean
2573298|NCT02497287|Primary|Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Recognition Discrimination Index|HVLT measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition.|Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)|All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Number of words||Standard Deviation|Mean
2573299|NCT02497287|Primary|Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Number of Words Recalled|HVLT measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition.|Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)|All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Number of words recalled||Standard Deviation|Mean
2573306|NCT02497287|Primary|Change From Baseline in Cognitive Test Battery: Detection Test (DET) Score|This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. The DET is a measure of psychomotor function and uses a well-validated simple reaction time. In this outcome measure, speed of performance of participants (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Total score ranges from 2 to 3.3 log 10 milliseconds (msec). Lower score indicates better performance. Higher change from baseline indicates better performance.|Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of Optimization/Maintenance [OP/MA] Phase)|All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||log10 msec||Standard Deviation|Mean
2573300|NCT02497287|Primary|Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Delayed Recall|HVLT measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition.|Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)|All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Number correct||Standard Deviation|Mean
2573301|NCT02497287|Primary|Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Total Recall|Hopkins Verbal Learning Test (HVLT) measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition.|Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)|All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Number correct||Standard Deviation|Mean
2573302|NCT02497287|Primary|Change From Baseline in Cognitive Test Battery: Groton Maze Learning Test (GMLT) Score|This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. GMLT measures executive function; maze/sequencing test, scored for total number of errors. Total score ranges from 0 to 999 number of errors. Lower score indicates better performance. Higher change from baseline indicates better performance.|Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)|All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Number of Errors||Standard Deviation|Mean
2573303|NCT02497287|Primary|Change From Baseline in Cognitive Test Battery: One Back Test (ONB) Score|The ONB is a measure of working memory and scored for speed of correct response (mean of the log10-transformed reaction times for correct responses). Total score ranges from 2 to 3.54 log10 msec. Lower score indicates better performance. Higher change from baseline indicates better performance.|Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)|All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||log10 msec||Standard Deviation|Mean
2573304|NCT02497287|Primary|Change From Baseline in Cognitive Test Battery: One Card Learning Test (OCL) Score|This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. OCL test is a measure of visual episodic memory and visual recall test scored using arcsine transformation of the percentage of correct responses (CR). The range for OCL is 0 to 100 percent (%) accuracy; presented as an arcsin transformation, the range is 0 to 1.57. Higher score indicates better performance. Higher change from baseline indicates better performance.|Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)|All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Arcsine ([sqrt] of proportion of [CR])||Standard Deviation|Mean
2573305|NCT02497287|Primary|Change From Baseline in Cognitive Test Battery: Identification Test (IDN) Score|This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. IDN test is a measure of visual attention (choice reaction time) and scored for speed of response (mean of the log10 transformed reaction times for correct responses). Total score ranges from 2 to 3.3 log 10 msec. Lower score indicates better performance. Higher change from baseline indicates better performance.|Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)|All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||log10 msec||Standard Deviation|Mean
2573317|NCT02496702|Secondary|Motivation for Training|Semi-structured interviews will be done with the participant after the intervention to investigate the motivation of the IMT.|At week 14.||||percentage of wanting to continue|||Number
2573318|NCT02496702|Secondary|Adherence to Training, Composite Outcome Measure.|Adherence to the training will be measured by registering the number of times the participants participate and how much they participate at each session.|At week 14||||percentage of sessions||95% Confidence Interval|Mean
2573307|NCT02497287|Primary|Percentage of Participants With Cystitis, Urinary Tract Infections, Renal and Urinary Tract Symptoms, Renal and Urinary Disorders|"Percentage of participants with cystitis, urinary tract infections, renal and urinary tract symptoms, renal and urinary disorders were evaluated. Cystitis and urinary tract infections are selected MedDRA preferred terms, renal and urinary tract symptoms refers to any preferred term (PT) in the group of selected PTs; and renal and urinary disorders refers to a MedDRA System Organ Class (SOC)."|Up to End of Follow up Phase (Week 56)|All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant.|||Percentage of participants|||Number
2573308|NCT02497287|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event is any untoward medical occurrence in a clinical study participants who administered a medicinal (investigational or non-investigational) product and does not necessarily have a causal relationship with the treatment. A TEAE defined as an event that was new in onset or increased in severity following treatment initiation.|Up to End of Follow up Phase (Week 56)|All enrolled analysis set included all transferred-entry and direct-entry participants who were not screen failures and received at least one dose of intranasal study medication or 1 dose of oral antidepressant.|||Percentage of participants|||Number
2573309|NCT02497235|Secondary|Percent Change From Baseline in the AUEC24 for Plasma 24S Hydroxycholesterol (24HC)|Percent change was calculated as = [(Postdose AUEC24(2) - Baseline AUEC24(2))/Baseline AUEC24(2)]*100 percent.|Baseline (Day -1): 1 hour and at multiple timepoints (up to 12 hours) post check in and Day 1: pre-dose and at multiple timepoints (up to 24 hours) post-TAK-935 dose|PK set included all participants who received TAK-935 and had at least 1 measurable plasma concentration for either TAK-935 or its M-1 metabolite. Data was reported for Participant 1 and 2 of each of TAK-935 50, 100, 200, and 300 mg arms and Participant 1, 2, and 3 of TAK-935 600 mg arm.|||percent change|||Number
2573310|NCT02497235|Secondary|Plasma Concentration of TAK-935 During Post-TAK-935 Dosing PET Scan Periods||At time 0 (just after tracer injection), 1 hour after tracer injection and 2 hours after tracer injection for each post-TAK-935 dosing PET scan period|Pharmacokinetic (PK) set included all participants who received TAK-935 and had at least 1 measurable plasma concentration for either TAK-935 or its M-1 metabolite. Data was reported for Participant 1 and 2 of each of TAK-935 50, 100, 200, and 300 mg arms and Participant 1, 2, and 3 of TAK-935 600 mg arm.|||nanogram per milliliter (ng/mL)|||Number
2573311|NCT02497235|Primary|CH24H Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 24 Hours Post-TAK-935 Dose|CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: VT (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - VND), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept.|24 hours post-TAK-935 dose|PET target occupancy set where 24 hour post-TAK-935-dose assessment were available. PET target occupancy set included all participants who received study drug (TAK-935) and had a technically adequate Baseline PET scan and at least 1 technically adequate post-TAK-935 dose PET scan.|||percentage of occupancy|||Number
2573312|NCT02497235|Primary|CH24H Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 10 Hours Post-TAK-935 Dose|CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: VT (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - VND), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept. Data was reported only for TAK-935 600 mg because only first two participants were analyzed at 10 hour post-TAK-935 dose.|10 hours post-TAK-935 dose|PET target occupancy set where 10 hour post-TAK-935-dose assessment were available. PET target occupancy set included all participants who received study drug (TAK-935) and had a technically adequate Baseline PET scan and at least 1 technically adequate post-TAK-935 dose PET scan.|||percentage of occupancy|||Number
2573313|NCT02497235|Primary|CH24H Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 2 Hours Post-TAK-935 Dose|CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: VT (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - VND), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept.|2 hours post-TAK-935 dose|PET target occupancy set where 2 hour post-TAK-935-dose assessment were available. PET target occupancy set included all participants who received study drug (TAK-935) and had a technically adequate Baseline PET scan and at least 1 technically adequate post-TAK-935 dose PET scan.|||percentage of occupancy|||Number
2573314|NCT02497235|Primary|Cholesterol 24S-Hydroxylase (CH24H) Brain Enzyme Occupancy as a Function of TAK-935 Plasma Concentration at 45 Minutes Post-TAK-935 Dose|CH24H brain enzyme occupancy was obtained by graphical analysis of global occupancy plot. Global occupancy plot was calculated as: total volume of distribution [VT] (Baseline) - VT (Day 1) = Occupancy (Day 1) * (VT [Baseline] - non-displaceable volume of distribution [VND]), where VT (Baseline) and VT (Day 1) are the total distribution volumes obtained at Baseline and after TAK-935 administration, respectively and VND is the non-displaceable volume of distribution. The occupancy is determined as the slope of the linear regression of the plot, and the VND as the x-intercept. Data was reported only for TAK-935 600 mg because only first two participants were analyzed at 45 minutes post-TAK-935 dose.|45 minutes post-TAK-935 dose|PET target occupancy set where 45 minutes post-TAK-935-dose assessment were available. PET target occupancy set included all participants who received study drug (TAK-935) and had a technically adequate Baseline PET scan and at least 1 technically adequate post-TAK-935 dose PET scan.|||percentage of occupancy|||Number
2573315|NCT02497040|Primary|Change in Mean Arterial Pressure||220+-70 minutes||||mmHg||Standard Deviation|Mean
2573316|NCT02496702|Secondary|Acceptability of IMT|Semi-structured interviews will be done with the participant after the intervention to investigate the acceptability of the IMT|At week 14.||||percentage of happy to train on IMT|||Number
2573327|NCT02496533|Primary|Change in Anxiety as Measured by Visual Analog Scale|Subjects self-reported their perceived anxiety by marking a visual analog scale (VAS). The VAS covers the range 0 to 10. Higher values indicate greater anxiety (worse outcome). Analysis based on difference reported anxiety score between Baseline and after imaging.|Baseline and After Imaging|All patients completing the study per protocol were included in the analysis.|||units on a scale||Standard Deviation|Mean
2573328|NCT02496221|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick|Urine dipstick test was carried out on Day -1 and at Follow-up. Urinalysis parameters assessed were glucose, ketones, nitrite and protein. Dipstick results were categorized as Normal (glucose), Negative or Trace (ketones), and Negative (nitrite and protein). Only participants available at the indicated time points (as represented by n=X, X, X in the category titles) were analyzed. The resultant fields with no available data have been represented by 'NA'.|Day -1 and Follow-up (assessed up to a total of approximately 12 weeks)|All Subjects|||Participants|||Number
2573329|NCT02496221|Secondary|Part A: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalised ratio >1.5. AEs were classified as potentially drug-related, based on the investigator's judgement. Refer to the general AE/SAE module for a list of AEs and SAEs.|From Day -1 in treatment period 1 and up to Follow-up Visit (a total of approximately 12 weeks)|All Subjects|||Participants|||Number
2573330|NCT02496221|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters|Single 12-lead ECG was obtained in a semi-supine position after 5 minutes of rest at each indicated time point using an ECG machine that automatically calculated the heart rate and measured the PR, QRS, QT, and QT corrected by Fridericia's formula (QTcF) intervals. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day -1) and Day 4 in each treatment period, and at Follow-up (at approximately Week 12)|All Subjects|||Milliseconds (msec)||Standard Deviation|Mean
2573331|NCT02496221|Secondary|Number of Participants With Clinical Chemistry and Hematology Abnormalities of Potential Clinical Importance|The following parameters were measured through blood sampling. Hematology: Hematocrit, Hemoglobin, Lymphocytes, Neutrophil Count, Platelet Count, While Blood Cell Count (WBC); Clinical Chemistry: Albumin, Calcium, Creatinine, Glucose, Magnesium, Phosphorus, Potassium, Sodium, Total carbon dioxide; Liver Function Tests: Alanine transaminase (ALT), Aspartate transaminase, Alkaline Phosphatase, Total Bilirubin, Total Bilirubin + ALT. Values were considered to be of potential clinical importance if they had a 'low' or 'high' flag with respect to a pre-defined clinical concern range. Only participants starting each period (represented by n=X) with a particular treatment were analyzed. The follow-up time point is not restricted to a treatment or treatment period.|Day -1 in each treatment period and Follow-up (at approximately Week 12)|All Subjects|||Participants|||Number
2573332|NCT02496221|Secondary|Change From Baseline in Heart Rate|Baseline is defined as Day 1 (pre-dose) visit. Heart rate was measured in a semi-supine position after 5 minutes of rest, at each indicated time point. Assessments were performed on Day -1, Day 2, Day 3 and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the indicated time points (represented by n=X,X in the category titles) were analyzed.|Day -1, Baseline Day 1(Pre-dose), Day 2, Day 3, and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4 in each treatment period and Follow-up (a total of approximately 12 weeks)|All Subjects|||Beats per minute (bpm)||Standard Deviation|Mean
2573333|NCT02496221|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Baseline is defined as Day 1 (pre-dose) visit. SBP and DBP were measured in a semi-supine position after 5 minutes of rest, at each indicated time point. Assessments were performed on Day -1, Day 1 (pre-dose), Day 2, Day 3 and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the indicated time points (represented by n=X,X in the category titles) were analyzed.|Day -1, Baseline Day 1(Pre-dose), Day 2, Day 3, and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4 in each treatment period and Follow-up (assessed up to a total of approximately 12 weeks)|All Subjects|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2573334|NCT02496221|Primary|Maximum Change From Baseline in Common Bile Duct Diameter During CCK Infusion|Common bile duct ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline is the average of the three diameter assessments at -15, -10, and -5 minutes relative to start of CCK infusion on Day 4. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value. Adjusted mean and its standard error have been presented.|Day 4 in each treatment period|Evaluable for Bile: Participants with Baseline and post-Baseline common bile duct diameter values for both periods|||Centimetre (cm)||Standard Error|Mean
2573335|NCT02496221|Primary|Maximum Change From Baseline in Main Pancreatic Duct Diameter During CCK Infusion|Pancreatic duct ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline is the average of the three diameter assessments at -15, -10, and -5 minutes relative to start of CCK infusion on Day 4. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value. Adjusted mean and its standard error are presented. Baseline was calculated as the value at the indicated time point minus the Baseline value. Only those participants available at the indicated time points were analyzed.|Day 4 in each treatment period|Evaluable for Pancreatic: Participants with Baseline and post-Baseline pancreatic duct diameter values for both periods|||Centimetre (CM)||Standard Error|Mean
2573336|NCT02496221|Primary|Time at Which the Maximum Effect (Emax VL) Occurred (TEmax VL) During the CCK Infusion|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion).|Day 4 in each treatment period|Evaluable Subjects|||Minutes||Standard Deviation|Mean
2573337|NCT02496221|Primary|Maximum Absolute Change From Baseline in Value of Gallbladder Volume (Emax VL) During CCK Infusion, as a Measure of Maximum Effect|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline gallbladder volume is the average of the 3 gallbladder volume measurements prior to CCK infusion on Day 4, for each treatment period. Adjusted mean and its standard error are presented.|Day 4 in each treatment period|Evaluable Subjects|||Millilitre (mL)||Standard Error|Mean
2573338|NCT02496221|Primary|Area Under the Effect Curve for Gallbladder Volume (AUEC VL)|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error is presented.|Day 4 in each treatment period|Evaluable Subjects|||mL*min||Standard Error|Mean
2573339|NCT02496221|Primary|Maximum Gallbladder Ejection Fraction Value During CCK Infusion|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion).|Day 1 and Day 4 in each treatment period|Evaluable Subjects|||Percentage||Standard Error|Mean
2573340|NCT02496221|Primary|Time at Which the Maximum Effect (Emax GEF) Occurred (TEMAXEF) During the CCK Infusion|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion).|Day 4 in each treatment period|Evaluable Subjects|||Minutes||Standard Deviation|Mean
2573341|NCT02496221|Primary|Area Under the Effect Curve for Gallbladder Ejection Fraction (AUEC GEF)|Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error have been presented.|Day 4 in each treatment period|Evaluable Subjects|||%*min||Standard Error|Mean
2573342|NCT02496221|Primary|Maximum Absolute Value of Gallbladder Ejection Fraction (Emax GEF) During Cholecystokinin (CCK) Infusion, as a Measure of Maximum Effect|Gallbladder ejection fraction (EF) is defined as the reduction in gallbladder volume at any time point from Baseline divided by baseline gallbladder volume and multiplied by 100. Baseline gallbladder volume is the average of the 3 gallbladder volume measurements prior to CCK infusion on Day 4, for each treatment period. Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error have been presented.|Day 4 in each treatment period|Evaluable Subjects: Participants in the ‘All Subjects’ population who had gallbladder ultrasonography assessment pre-treatment and post-Baseline (during CCK infusion) for both periods. 'All Subjects' population comprised participants who received at least one dose of Investigational product.|||Percent of gallbladder EF||Standard Error|Least Squares Mean
2573343|NCT02496091|Secondary|Marginal Bone Level Change|Marginal bone level (MBL) determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the study follow-up visit was compared to values obtained at delivery of permanent restoration i.e. loading (baseline), or within the first 12 months after loading.|Minium of 2 years and a maximum of 8 years of use.|Per protocol population is 142 subjects (259 positions) . For 39 subjects (94 positions) there were no baseline radiographs available for analysis. As a result, a total of 165 positions are included in the analysis of MBL change.|||Millimeter||Standard Deviation|Mean
2573344|NCT02496091|Secondary|Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP|"Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). BoP was evaluated at four surfaces around each study position (mesial, facial, distal and lingual), using a periodontal probe.~BoP was recorded as presence or absence of bleeding when probing to the bottom of the pocket. Presented as % of positions that show presence of bleeding on probing at time of the follow-up visit."|Minium of 2 years and a maximum of 8 years of use.|"144 subjects (263 implant positions) were enrolled in the study. 2 subject (4 implant positions) were excluded due to eligibility criteria not fulfilled giving a per protocol population of 142 subjects (259 positions) .~PPD assessment was not completed for 4 positions. As a result, a total of 255 positions are included in the PPD analysis."|||Positions|Positions||Count of Units
2573345|NCT02496091|Secondary|Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD|PPD was evaluated at four surfaces around each study position (mesial, facial, distal and lingual), using a periodontal probe. PPD was measured as the distance from the mucosal margin to the bottom of the probeable pocket in whole millimetre. PPD mean values per study positon were calculated.|Minium of 2 years and a maximum of 8 years of use.|"144 subjects (263 implant positions) were enrolled in the study. 2 subject (4 implant positions) were excluded due to eligibility criteria not fulfilled giving a per protocol population of 142 subjects (259 positions) .~PPD assessment was not completed for 4 positions. As a result, a total of 255 positions are included in the PPD analysis."|||Millimeter|Position|Standard Deviation|Mean
2573514|NCT02494336|Secondary|Use of Post-operative Intravenous/Oral Opioid and Non-opioid|number of doses of postoperative intravenous opioid and non-opioid medications received by patient number of doses of postoperative oral opioid and non-opioid medications received by patient|5 days||2020-03-31|03/2020||||
2573346|NCT02496091|Secondary|Presence of Plaque|Presence of plaque was evaluated at four surfaces around each study position (mesial, facial, distal and lingual). Plaque was recorded as presence or absence of plaque by visual inspection.|Minium of 2 years and a maximum of 8 years of use.|"144 subjects (263 implant positions) were enrolled in the study. 2 subject (4 implant positions) were excluded due to eligibility criteria not fulfilled giving a per protocol population of 142 subjects (259 positions) .~Plaque assessment was not completed for 4 positions. As a result, a total of 255 positions are included in the Plaque analysis."|||Positions|Positions||Count of Units
2573347|NCT02496091|Secondary|Study Position Implant and Abutment Survival|"Survival defined as study position implant and abutment in situ during study. The presence of the study position implant and abutment in the mouth was recorded. The implant and abutment had to be the ones included in the permanent prosthetic restoration when it was delivered / installed.~Each study position was categorized as survived (No/Yes). It was categorized as survived=Yes when both had been in situ during study. It was categorized as survived=No when either the implant or abutment had been lost during study."|Minium of 2 years and a maximum of 8 years of use.|144 subjects (263 implant positions) were enrolled in the study. 2 subject (4 implant positions) were excluded due to eligibility criteria not fulfilled giving a per protocol population of 142 subjects (259 positions).|||Abutments|Abutments||Count of Units
2573348|NCT02496091|Primary|Overall Success Rate|Success defined as study position implant and abutment in situ and no Adverse Event(s) related to implant, abutment or adjacent peri-implant tissues reported during study.|Minium of 2 years and a maximum of 8 years of use.|"144 subjects (263 implant positions) were signed informed consent and were enrolled in the study. 2 subject (4 implant positions) were excluded due to eligibility criteria not fulfilled.~As a result, a total of 142 subjects (259 implant positions) are included in the analysis."|||Abutments|Abutments||Count of Units
2573349|NCT02496039|Primary|Scores on the Impact of PBA on Informant Scale|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days|||||||
2573350|NCT02496039|Primary|Number of Participants Using Concomitant Psychotropic Medication|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days|||||||
2573351|NCT02496039|Primary|Scores on the Minimum Data Set (MDS) Sections of Presumed Relevance to PBA, Including Sections on Speech, Cognition, Mood, Behavior, Health Condition, and Medication|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days|||||||
2573352|NCT02496039|Primary|Scores on the Impact of Pseudobulbar Affect (PBA) on Participant Scale|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days|||||||
2573353|NCT02496039|Primary|Number of Participants With the Indicated Responses to the Neuropsychiatric Inventory-Nursing Home (NPI-NH) Questionnaire|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days|||||||
2573354|NCT02496039|Primary|Scores on the Patient Global Impression of Change (PGIC) Scale|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days|||||||
2573355|NCT02496039|Primary|Scores on the Clinical Global Impression of Change (CGIC) Scale|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days|||||||
2573356|NCT02496039|Primary|Scores on the Clinical Global Impression of Severity of Illness (CGIS) Scale|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days|||||||
2573357|NCT02496039|Primary|Scores on the Center for Neurologic Study-Lability Scale (CNS-LS)|The study was terminated prematurely because of difficulty with recruiting. Analysis for this outcome measure was not performed because data were not collected prior to termination.|180 days|||||||
2573358|NCT02496000|Secondary|The Effect of ORMD-0801 on the Percent Change in HbA1c|The effect of ORMD-0801 (Dose 1 and Dose 2 individually) on the percent change from baseline to Wk 4 in HbA1c|Study day 1 (± 1 day) through Study day 29 (± 1 day)|Intend To Treat (ITT) population|||percent change||Standard Deviation|Mean
2573359|NCT02496000|Secondary|Measure the Change From Baseline to End of the Study of Morning Fasting C-Peptide (Nmol/L)|The measurement of the change in Morning Fasting C-peptide between baseline to end of the study, measured in Nmol/L|Study day 1 (±1 day) through Study day43 (± 1 day)|Intend to Treat (ITT) population|||Nmol/L||Standard Deviation|Mean
2573360|NCT02496000|Secondary|Measure Percent Change in Continuous Glucose Monitoring Mean Fasting Glucose Between Treatment and Run-In|The percent change in the Continuous Glucose Monitoring Mean Fasting Glucose between treatment and mean of the last two days of the baseline(run-in period).|Baseline (Run-in days 13-14) and Study day 1 (± 1 day) through Study day 29 (± 1 day)|Intend to Treat (ITT)|||percent change||Standard Deviation|Mean
2573361|NCT02496000|Secondary|The Effect of ORMD-0801 on Mean 24-hour Glucose|The effect of ORMD-0801 (Dose 1 and Dose 2 individually) on mean 24-hour glucose based on 2 nights of CGM data by comparison of the mean percent change between baseline and Wk 4 of ORMD-0801 treatment and the placebo groups.|Study day -7 (± 1 day) through Study day 1 (± 1 day), and Study day 22 (±1 day) - Study day 29 (± 1 day)||||percent change||Standard Deviation|Mean
2573393|NCT02495467|Secondary|Sexual Desire Domain Score of the International Index of Erectile Function (IIEF)|Sexual desire domain of the International Index of Erectile Function (IIEF) questionnaire. This will be measured at the end of treatment periods of 4 weeks (+/- 1 week). The minimum and maximum values are 2-10, a lower score is regarded as having a worse outcome.|4 Weeks|Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.|||score on a scale||Standard Deviation|Mean
2573515|NCT02494336|Secondary|Operative Time|Operative time is measured as the time between X and Y. Reported in minutes/hours|1 day|||||||
2573362|NCT02496000|Primary|Measure of the Mean Night Time Glucose Levels Based on Two Nights of Glucose Measurements.|The Effect of ORMD-0801 (Doses 1 & 2, Pooled) on Mean Night Time Glucose Levels (measured in mg/dL) Based on 2 Nights of Continuous Glucose Monitor (CGM) Data by Comparison of the Mean Change Between Baseline and Wk 4 of ORMD-0801 Treatment and Placebo Groups. The primary analysis will be based on the results from the two last days, unless technical difficulties preclude calculation of the weighted mean glucose levels. In this case, the last two days (selected between days 5, 6, and 7) with at least 80% of the expected number of measurements will be used. If days 5, 6 and 7 do not have 2 days with at least 80% of the expected number of measurements for a specific subject, then the value will be missing for that subject.|Baseline-Study day -7 (± 1 day) through Study day 1 (± 1 day), and Week 4 -Study day 22 (± 1 day) through Study day 29 (± 1 day)|Intend-to-Treat Population, 80% trimming. The mean values will be analyzed using a one-way analysis of variance (ANOVA) model. The residuals from the ANOVA will be analyzed to verify that they are normally distributed. If not normally distributed, then a Kruskal-Wallis test (one-way analysis of variance on the ranks) will be performed.|||mg/dL||Standard Deviation|Mean
2573363|NCT02495948|Primary|Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear|The contact lens (right eye) was removed and stored dry and frozen until analysis. Total cholesterol deposits (cholesterol and cholesterol esters) were extracted from the lens and measured in micrograms. Lower deposits indicate increased lens performance. Study originally intended to analyze 36 lenses per arm, but actual number of lenses analyzed was less due to measurement error.|Day 30, each product|Intent-to-Treat analysis set|||micrograms|Lenses|Standard Deviation|Mean
2573364|NCT02495844|Secondary|Number of Subject Withdrawals Due to Adverse Events (AEs) During the Course of the Study|Number of subjects who withdrew from the study due adverse event (reported by the subject and/or caregiver or observed by the Investigator or inpatient staff).|All study duration (approximately 19 to 20 weeks)||||Participants|||Number
2573365|NCT02495844|Secondary|Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study|Number of subjects experiencing at least one serious adverse event (reported by the subject and/or caregiver or observed by the Investigator or inpatient staff).|All study duration (approximately 19 to 20 weeks)||||Participants|||Number
2573366|NCT02495844|Secondary|Percentage of Seizure-free Days (All Seizures) During the Outpatient Maintenance Period||During the Outpatient Maintenance Period (8 weeks)||||percentage of days||Inter-Quartile Range|Median
2573367|NCT02495844|Secondary|Percentage of Seizure Free Days (All Seizures) During the 2-week Inpatient Period|For the active group, the 2-week Inpatient Period refers to the last 2 weeks of the Inpatient Period, while for the Placebo group, it refers to the first 2 weeks of the Inpatient Period.|During the 2-week Inpatient Period||||percentage of days||Inter-Quartile Range|Median
2573368|NCT02495844|Secondary|75 % Responder Rate During the On-UCB0942 Overall Period|The 75 % responder rate is defined as the percentage of subjects who achieve a 75 % or greater reduction in focal seizure frequency.|During the On-UCB0942 Overall Period (approximately 11 weeks)||||percentage of participants|||Number
2573369|NCT02495844|Secondary|75 % Responder Rate During the Last 4 Weeks of the Outpatient Maintenance Period|The 75 % responder rate is defined as the percentage of subjects who achieve a 75 % or greater reduction in focal seizure frequency.|During the last 4 weeks of the Outpatient Maintenance Period||||percentage of participants|||Number
2573370|NCT02495844|Secondary|Seizure-free Rate (All Seizures) During the On-UCB0942 Overall Period|Seizure-free rate is reported as the percentage of seizure-free participants during the On-UCB0942 Overall Period.|During the On-UCB0942 Overall Period (approximately 11 weeks)||||percentage of participants|||Number
2573371|NCT02495844|Secondary|Seizure-free Rate (All Seizures) During the Last 4 Weeks of the Outpatient Maintenance Period|Seizure-free rate is reported as the percentage of seizure-free participants during the last 4 weeks of the Outpatient Maintenance Period.|During the last 4 weeks of the Outpatient Maintenance Period||||percentage of participants|||Number
2573372|NCT02495844|Secondary|Seizure-free Rate (All Seizures) During the 2-week Inpatient Period|Seizure-free rate is reported as the percentage of seizure-free participants during the 2-week Inpatient Period.|During the 2-week Inpatient Period||||percentage of particpants|||Number
2573373|NCT02495844|Secondary|Median Percent Change in Weekly Focal Seizure Frequency During the On-UCB0942 Overall Period|A negative value in median percent change reflects a reduction from Baseline.|During the On-UCB0942 Overall Period (approximately 11 weeks)||||percentage of change||Inter-Quartile Range|Median
2573374|NCT02495844|Secondary|Median Percent Change in Weekly Focal Seizure Frequency During the Outpatient Maintenance Period|A negative value in median percent change reflects a reduction from Baseline.|During the Outpatient Maintenance Period (8 weeks)||||percentage of change||Inter-Quartile Range|Median
2573375|NCT02495844|Secondary|Median Percent Change in Weekly Focal Seizure Frequency During the 2-week Inpatient Period|A negative value in median percent change reflects a reduction from Baseline.|During the 2-week Inpatient Period||||percentage of change||Inter-Quartile Range|Median
2573376|NCT02495844|Primary|75 % Responder Rate During the 2-week Inpatient Period|The 75% responder rate is defined as the percentage of subjects with a 75 % or greater reduction in focal seizure frequency during the 2-week Inpatient Period compared with the Baseline Period.|During the 2-week Inpatient Period||||percentage of participants|||Number
2573377|NCT02495831|Secondary|Relative Bioavailability (Frel)|calculated as ratio between AUC0-t (test) / AUC0-t (reference)|24 hours||||ratio||Standard Deviation|Mean
2573378|NCT02495831|Secondary|Lamda z||24 hours||||1/hours||Standard Deviation|Mean
2573379|NCT02495831|Secondary|Tmax and T1/2||24 hours||||hours||Standard Deviation|Least Squares Mean
2573380|NCT02495831|Secondary|Evaluate Diclofenac Rate of Absorption Reported as Plasma Cmax After Single Administration of 50 mg Diclofenac With and Without 200 mg of Safinamide.|Cmax, of plasma diclofenamic acid after T2 single dose, with and without T1 co-administration. The parametric point estimators (PE) for the ratios of T2 treatment with T1 co-administration / T2 treatment without T1 co-administration for the PK parameters under consideration, and the two-sided 90% confidence interval (CI), were calculated using the adjusted least squares means (LSMEANS) from the ANOVA. LSmeans differences obtained in the log scale for Cmax were back-transformed to obtain the PE (i.e. geometric mean ratio) and the two-sided 90% CI as percentages.|24 hours||||ng/mL||Standard Deviation|Least Squares Mean
2573381|NCT02495831|Primary|To Evaluate Plasma Diclofenamic Acid Extent of Exposure Reported as Plasma AUC After Single Administration of 50 mg Diclofenac Sodium, With and Without Co-administration of a Single 200 mg Dose of Safinamide.|Plasma diclofenamic acid AUC0-t after T2 single dose, with and without T1 co-administration. To measure AUC plasma samples were taken by the participants at different time points, and the concentrations of diclofenac and safinamide were measured. AUC0-t is the area under the concentration-time curve from administration to the last observed concentration time t; PK parameters AUC0-t were analysed using analysis of variance (ANOVA). Before analysis, the data were transformed using a neperian logarithmic transformation. ANOVA was performed taking into account treatment, period, sequence and subject (sequence) as fixed effects with a variance components structure of the covariance matrix.|24 hours|healthy volunteers|||h X ng per mL||Standard Deviation|Mean
2573382|NCT02495779|Primary|Number of Participants With PrEP Adherence|Biological measure of medication in the blood. Adherence will be measured using plasma analyses. We used the cut off of 4 doses/week to determine protective levels of adherence. The determination of this was drug levels equal to TFV 4.2 ng/mL FTC 4.6 ng/mL.|Blood will be drawn upon within 3 days post-vacation (average 2 weeks after starting PrEP)||||Participants|||Count of Participants
2573383|NCT02495623|Primary|Change From Baseline in the Area Under the Curve (AUC) of Breath CH4 Production at Day 7||7 days|79 subjects consented/randomized to treatment. 63 dosed subjects. 59 subjects (21, 20 & 18 for the placebo, 21mg and 42mg, respectively) were included for the analysis of AUC on Day 7, and the subjects with missing CH4 values at either baseline or Day 7 were excluded from the analysis since the area under the curve could not be calculated.|||hours*ppm||Standard Deviation|Mean
2573384|NCT02495467|Secondary|Number of Participants With Affirmative Response to Global Assessment Questionnaire (GAQ) Question 2|"GAQ Question 2: Has the treatment improved your ability to engage in sexual activity?. Answered yes/no after each treatment period of 4 weeks (+/- 1 week)."|4 Weeks|Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Complete cases only.|||Participants|||Count of Participants
2573385|NCT02495467|Secondary|Number of Participants With Affirmative Response to Global Assessment Questionnaire (GAQ) Question 1|"GAQ Question 1: Has the treatment you have been taking improved your erectile function?. Answered yes/no after each treatment period of 4 weeks (+/- 1 week)."|4 Weeks|Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Complete cases only.|||Participants|||Count of Participants
2573386|NCT02495467|Secondary|Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 5|"SEP Question 5: Were you satisfied overall with this sexual experience?. Answered yes/no after each intercourse event during treatment periods of 4 weeks (+/- 1 week). Assessed as a percentage of yes responses in each period."|4 Weeks|Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.|||percentage of yes responses||Standard Deviation|Mean
2573387|NCT02495467|Secondary|Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 4|"SEP Question 4: Were you satisfied with the hardness of your erection?. Answered yes/no after each intercourse event during treatment periods of 4 weeks (+/- 1 week). Assessed as a percentage of yes responses in each period."|4 Weeks|Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.|||percentage of yes responses||Standard Deviation|Mean
2573388|NCT02495467|Secondary|Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 3|"SEP Question 3: Did your erection last long enough for you to have successful intercourse?. Answered yes/no after each intercourse event during treatment periods of 4 weeks (+/- 1 week). Assessed as a percentage of yes responses in each period."|4 Weeks|Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.|||percentage of yes responses||Standard Deviation|Mean
2573389|NCT02495467|Secondary|Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 2|"SEP Question 2: Were you able to insert your penis into your partner's vagina?. Answered yes/no after each intercourse event during treatment periods of 4 weeks (+/- 1 week). Assessed as a percentage of yes responses in each period."|4 Weeks|Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.|||percentage of yes responses||Standard Deviation|Mean
2573390|NCT02495467|Secondary|Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 1|"SEP Question 1: Were you able to achieve at least some erection (some enlargement of the penis)?. Answered yes/no after each intercourse event during treatment periods of 4 weeks (+/- 1 week). Assessed as a percentage of yes responses in each period."|4 Weeks|Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.|||percentage of yes responses||Standard Deviation|Mean
2573391|NCT02495467|Secondary|Overall Satisfaction Domain Score of the International Index of Erectile Function (IIEF)|Overall satisfaction domain of the International Index of Erectile Function (IIEF) questionnaire. This will be measured at the end of treatment periods of 4 weeks (+/- 1 week). The minimum and maximum values are 2-10, a lower score is regarded as having a worse outcome.|4 weeks|Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.|||score on a scale||Standard Deviation|Mean
2573392|NCT02495467|Secondary|Intercourse Satisfaction Domain Score of the International Index of Erectile Function (IIEF)|Intercourse satisfaction domain of the International Index of Erectile Function (IIEF) questionnaire. This will be measured at the end of treatment periods of 4 weeks (+/- 1 week). The minimum and maximum values are 0-15, a lower score is regarded as having a worse outcome.|4 Weeks|Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.|||score on a scale||Standard Deviation|Mean
2573394|NCT02495467|Secondary|Orgasmic Function Domain Score of the International Index of Erectile (IIEF)|Orgasmic function domain of the International Index of Erectile Function (IIEF) questionnaire. This will be measured at the end of treatment periods of 4 weeks (+/- 1 week). The minimum and maximum values are 1-10, a lower score is regarded as having a worse outcome.|4 Weeks|Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.|||score on a scale||Standard Deviation|Mean
2573395|NCT02495467|Primary|Erectile Function (EF) Domain Score of the International Index of Erectile Function (IIEF)|Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) questionnaire. This will be measured at the end of the treatment periods of 4 weeks (+/- 1 week). The minimum and maximum values are 1-30, a lower score is regarded as more severe.|4 Weeks|Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.|||score on a scale||Standard Deviation|Mean
2573396|NCT02495259|Secondary|Throat Pain|Any voice change in the patient after extubation will be assessed in the Post-Operative Admission Unit (PACU) by recording the patient's response to the degree of pain experienced. An analog pain scale will be used for scoring where: 0= no pain and 10= severe pain. The average time for the patient to sufficiently recover to respond is expected to be 60 minutes after extubation.|Up to 60 minutes after extubation||||units on a scale||Standard Deviation|Mean
2573397|NCT02495259|Secondary|Number of Cases of Voice Change|Any voice change in the patient after extubation will be assessed in the Post-Operative Admission Unit (PACU) by asking the patient if any change in voice is experienced (Yes/No). The subjective answer given by the patient will be recorded. The average time for the patient to sufficiently recover to respond is expected to be 60 minutes after extubation.|Up to 60 minutes after extubation||||cases of voice change|||Number
2573398|NCT02495259|Secondary|Number of Cases With Complications|Number of cases with complications during intubation will be will be assessed by the anesthetist's responses to a multi-question form which includes the following items; blood on device, SpO2 (peripheral capillary oxygen saturation) <96%, lip and dental trauma and double-lumen endobronchial tube (DLT) cuff rupture. The responses are recorded as Yes or No for each item. A 'yes' response indicates a complication. The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2).|during laryngoscope placement, up to 120 seconds||||cases of complications|||Number
2573399|NCT02495259|Secondary|Assessment of Difficulty of Intubation|The ease of successful placement of the double-lumen endobronchial tube (DLT) will be assessed by the anesthetist's responses to a multi-question form which includes the following items that are scored; overall ease of intubation, laryngoscope insertion, glottic view, double-lumen endobronchial tube (DLT) delivery and placement. The subjective scores range from 0-10; where 0=worst, 10=best. The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2).|during laryngoscope placement, up to 120 seconds||||units on a scale||Standard Deviation|Mean
2573400|NCT02495259|Secondary|Success Rate of First Endobronchial Intubation Attempt|The rate of first intubation attempt success will be recorded by the anesthetist. A successful first attempt intubation is when the double-lumen endobronchial tube is placed during the initial laryngoscopy within 120 seconds. The average time for successful intubation is 120 seconds, which is the time from when the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2). Higher numbers of successful first attempt intubations indicate better rates of success of first endobronchial intubation attempts .|during laryngoscope placement, up to 120 seconds||||Participants|||Count of Participants
2573401|NCT02495259|Primary|Mean Time to Place the Double-lumen Endobronchial Tube|The time taken for successful intubation will be recorded by the anesthetist. The total duration from the time the laryngoscope is placed at the patient's lips to the first detection of End-tidal CO2 (EtCO2), an average of 120 seconds, will be recorded in seconds. A higher duration noted is indicative of a longer time taken for successful intubation. 0 seconds (laryngoscope at patient's lips), (first End-tidal CO2 (EtCO2) detection)|during laryngoscope placement, up to 120 seconds||||sec||Standard Deviation|Mean
2573402|NCT02495233|Secondary|Objective Response Rate (ORR) in Phase 1b|ORR was defined as Objective Response Rate (ORR) was the proportion of patients whose best overall response was complete response (CR) or partial response (PR) per RECIST version 1.1. Only patients with measurable disease at baseline were to be included in the analysis of ORR.|End of treatment (approximately 4 months)|ASAT consisted of all participants allocated to treatment.|||percentage of participants|||Number
2573403|NCT02495233|Secondary|Ctrough of Erlotinib||Day 8, 15, 22, 28 of cycle 1|PKAS|||ng/mL||Standard Deviation|Mean
2573404|NCT02495233|Secondary|Tmax of Erlotinib||0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1|PKAS|||hr||Standard Deviation|Mean
2573405|NCT02495233|Secondary|Cmax of Erlotinib||0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1|PKAS|||ng/mL||Standard Deviation|Mean
2573406|NCT02495233|Secondary|AUC24 of Erlotinib||0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Day 28 of cycle 1|PKAS|||h*ng/mL||Standard Deviation|Mean
2573407|NCT02495233|Secondary|Concentration Immediately Prior to Dosing at Multiple Dosing (Ctrough) of Gilteritinib|All participants in Gilteritinib 120 mg + Erlotinib 150 mg group discontinued before cycle 3.|Predose on Day 1, 3, 8, 15, 22, 28 of cycle 1, Day 1 of cycle 3 and Day 1 of cycle 4|PKAS|||ng/mL||Standard Deviation|Mean
2573408|NCT02495233|Secondary|Time After Dosing When Cmax Occurs (Tmax) for Gilteritinib||0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1|PKAS|||hr||Standard Deviation|Mean
2573409|NCT02495233|Secondary|Maximum Concentration (Cmax) for Gilteritinib||0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1|PKAS|||ng/mL||Standard Deviation|Mean
2573410|NCT02495233|Secondary|Area Under the Concentration-time Curve at 24 Hours (AUC24) for Gilteritinib||0, 0.5, 1, 2, 4, 6, 24 hours post-dose on Days 1 and 28 of cycle 1|Pharmacokinetic Analysis Set (PKAS) consisted of all participants who received at least 1 dose of study drugs for whom sufficient plasma concentration data were available to facilitate derivation of at least 1 pharmacokinetic parameter and for whom the time of dosing on the day of sampling was known.|||h*ng/mL||Standard Deviation|Mean
2573411|NCT02495233|Primary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) that started after administration of the study drugs and occurred within 30 days of the last dose of the study drugs. If a participant experienced an event both during the preinvestigational period and during the investigational period, the event was considered a TEAE only if it worsened in severity.|From first dose of study drug up to 30 days after the last dose of study (maximum study drug exposure 114 days)|SAF|||Participants|||Count of Participants
2573412|NCT02495233|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)||Cycle 1 and Cycle ≥2 (up to 141 days)|Safety Analysis Set (SAF) consisted of all participants who received at least one dose of study drugs. DLT evaluable set (DES), was a subset of SAF and included participants who were either administered with at least 75% of planned dose during cycle 1 or experienced DLT during cycle 1.|||Participants|||Count of Participants
2573413|NCT02495168|Primary|Superiority Analysis of Baseline-Adjusted Average Predose FEV1 at End of Treatment|FEV1 was measured using spirometry in accordance with the ATS/ERS consensus guidelines. Average predose FEV1 at End of Treatment defined as the average of all predose assessments on Day 42. If a participant had no predose assessment on Day 42, the average of all available predose assessments on the last day (for example, Early Termination visit [up to Day 50]) when at least 1 predose FEV1 assessments was available was imputed, if the participant discontinued due to lack of efficacy, otherwise there was no imputation. Baseline was defined as the average of at least 2 predose FEV1 values obtained on Day 1. The endpoint of baseline-adjusted predose FEV1 at end of treatment was calculated as follows: [FEV1 at end of treatment] - [Baseline FEV1].|Day 1 up to Day 50|Randomized participants who received at least 1 dose of study drug, no major inclusion/exclusion violations, and enrolled in the study only once (mITT Population) and with evaluable baseline-adjusted average predose FEV1 data.|||liters||Standard Deviation|Mean
2573414|NCT02495168|Primary|Equivalence Analysis of Baseline-Adjusted Average Predose FEV1 at End of Treatment|FEV1 was measured using spirometry in accordance with the ATS/ERS consensus guidelines. Average predose FEV1 at End of Treatment defined as the average of all predose assessments on Day 42. If a participant had no predose assessment on Day 42, the average of all available predose assessments on the last day (for example, Early Termination visit [up to Day 50]) when at least 1 predose FEV1 assessments was available was imputed, if the participant discontinued due to lack of efficacy, otherwise there was no imputation. Baseline was defined as the average of at least 2 predose FEV1 values obtained on Day 1. The endpoint of baseline-adjusted predose FEV1 at end of treatment was calculated as follows: [FEV1 at end of treatment] - [Baseline FEV1].|Day 1 up to Day 50|Randomized participants who received at least 1 dose of study drug, no major inclusion/exclusion violations, enrolled in the study only once, and no major protocol violations that impacted analysis of the Day 42 FEV1 AUC (D42PPS Population).|||liters||Standard Deviation|Mean
2573415|NCT02495168|Primary|Superiority Analysis of Area Under the Serial FEV1-Time Effect Curve From Time 0 to 12 Hours (FEV AUC0-12) on the First Day of Treatment|FEV1 was measured using spirometry in accordance with the ATS/ERS consensus guidelines. Baseline-adjusted area under the serial FEV1-time curve was calculated from Time 0 to 12 hours on the first day of the Treatment Period (Day 1). FEV1 AUC0-12 was calculated from baseline-adjusted values using the linear trapezoidal method. The calculation assumed that at time of dosing (Time 0) the baseline adjusted FEV1 was also 0. The calculation proceeded over all available post-dose FEV1 assessments on Day 1 (including unscheduled time points, if any) using actual elapsed time from dosing. FEV1 baseline defined as the average of predose FEV1 values obtained on Day 1. If some of these values were missing, the average was calculated using the available values, however, a minimum of 2 predose FEV1 values were required; participants who had only 1 or no predose FEV1 measurements on Day 1 would have their FEV1 baseline missing, and the participant was to be excluded from analysis.|0 to 12 hours on Day 1|Randomized participants who received at least 1 dose of study drug, no major inclusion/exclusion violations, and enrolled in the study only once (mITT Population) and with evaluable FEV1 AUC data.|||Lh||Standard Deviation|Mean
2573416|NCT02495168|Primary|Equivalence Analysis of Area Under the Serial FEV1-Time Effect Curve From Time 0 to 12 Hours (FEV1 Area Under Curve [AUC0-12]) on the First Day of Treatment|FEV1 was measured using spirometry in accordance with the ATS/ERS consensus guidelines. Baseline-adjusted area under the serial FEV1-time curve was calculated from Time 0 to 12 hours on the first day of the Treatment Period (Day 1). FEV1 AUC0-12 was calculated from baseline-adjusted values using the linear trapezoidal method. The calculation assumed that at time of dosing (Time 0) the baseline adjusted FEV1 was also 0. The calculation proceeded over all available post-dose FEV1 assessments on Day 1 (including unscheduled time points, if any) using actual elapsed time from dosing. FEV1 baseline defined as the average of predose FEV1 values obtained on Day 1. If some of these values were missing, the average was calculated using the available values, however, a minimum of 2 predose FEV1 values were required; participants who had only 1 or no predose FEV1 measurements on Day 1 would have their FEV1 baseline missing, and the participant was to be excluded from analysis.|0 to 12 hours on Day 1|Randomized participants who received at least 1 dose of study drug, no major inclusion/exclusion violations, enrolled in the study only once, and no major protocol violations that impacted analysis of the Day 1 FEV1 AUC (D1PPS Population).|||Liter*hour (Lh)||Standard Deviation|Mean
2573417|NCT02495038|Other Pre-specified|Bispectral Index|"The BIS monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100. A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer.~Before induction of anesthesia, bispectral index was measured for baseline. And after injection of NMBAs, bispectral index was measured at 10 min."|Before and after induction of anesthesia, an average 10 min.||||BIS score||Standard Deviation|Mean
2573418|NCT02495038|Other Pre-specified|Body Temperature|"Before induction of anesthesia, body temperature was measured for baseline by oral temperature probe.~And after injection of NMBAs, non invasive blood pressure was measured at 10 min by esophageal temperature probe."|Before and after induction of anesthesia, an average 10 min.||||Celcius degree||Standard Deviation|Mean
2573419|NCT02495038|Other Pre-specified|Peripheral Oxygen Saturation|"Before induction of anesthesia, peripheral oxygen saturation was measured for baseline.~And after injection of NMBAs, peripheral oxygen saturation was measured at 10 min."|Before and after induction of anesthesia, an average 10 min.||||Percentage||Standard Deviation|Mean
2573421|NCT02495038|Secondary|Additional Rescue Doses Per Hour Ratio.|Additional Rescue Doses Per Hour Ratio is the number per hour of addition of rescue dose administrated with 10% of initial NMBAs dose. The formula is {(Addition number + 1 / Anesthetic time) x 60}.|Intraoperative, an average of 3 hours.||||ratio||Standard Deviation|Mean
2573422|NCT02495038|Secondary|Anesthetic Time|Time from induction to recovery of anesthesia, asessed up to 3 hours.|Intraoperative, an average 4 hours.||||Minute||Standard Deviation|Mean
2573423|NCT02495038|Secondary|Operation Time|Time from skin incision to wound dressing assessed up to 8 hours.|Intraoperative, an average of 3 hours.||||Minute||Standard Deviation|Mean
2573424|NCT02495038|Primary|Recovery Index of Neuromuscular Blocking Agents(NMBAs)|Time from TOF ratio 25% to 75%, assessed up to 1 hour during general anesthesia.|Intraoperative, an average of 20 minutes||||Minute||Standard Deviation|Mean
2573425|NCT02495038|Primary|Duration 25% of Neuromuscular Blocking Agents(NMBAs)|Time from administration of initial NMBAs to Train-of-four (TOF) ratio >25%, assessed up to 2 hours during general anesthesia.|Intraoperative, an average of 1 hours||||Minute||Standard Deviation|Mean
2573426|NCT02495038|Primary|Onset of Neuromuscular Blocking Agents(NMBAs)|Time from administration of initial NMBAs to Train-of-four (TOF) ratio=0, assessed up to 15 minutes during general anesthesia.|Intraoperative, an average of 5 minutes||||Second||Standard Deviation|Mean
2573427|NCT02495025|Secondary|Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always|Based on parent interviews we will assess family experiences with primary care including receipt of recommended well-child care, using recommended anticipatory guidance and family-centered care items from the Promoting Healthy Development Survey (PHDS)|Baseline and 6 months|Restricted to participants with parent interview at both baseline and 6-month follow-up.|||percentage of items||Standard Deviation|Mean
2573428|NCT02495025|Secondary|Number of Participants Referred for Evaluation/Services (Early Intervention or Early Childhood Special Education)|Based on medical record review, parent report, and 211 data, we measured whether any referrals were made for children with developmental or behavioral concerns, for evaluation or services.|6 months||||Participants|||Count of Participants
2573429|NCT02495025|Primary|Number of Participants That Receive Services|Based on medical record review, parent report, and 211 data, we will measure whether children are receiving intervention services, including Early Intervention or Special Education.|6 months||||Participants|||Count of Participants
2573430|NCT02495025|Primary|Number of Participants Screened With a Validated Tool|We will measure whether developmental screening was done using a validated instrument, as recommended by the AAP. Specific screening instruments include the Parental Evaluation of Developmental Status (PEDS), the PEDS: Developmental Milestones (PEDS:DM), the Ages and Stages Questionnaires (ASQ), and/or the Modified Checklist for Autism in Toddlers (MCHAT), Revised version.|6 months||||Participants|||Count of Participants
2573431|NCT02494817|Secondary|Test for HIV During the Last 3 Months (Months 3-6)|Self-reports of yes/no any test for HIV at month 6 assessment, collected via electronic survey for timeframe between months 3 and 6.|month 6|213 partnered men who completed 6-month assessment|||Participants|||Count of Participants
2573432|NCT02494817|Secondary|Test for HIV During Past 3 Months (Months 0-3)|Self-reports of yes/no via electronic survey taken at 3 month.|3 month||||Participants|||Count of Participants
2573433|NCT02494817|Secondary|Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6|Self-reports of yes/no any anal sex with casual male sex partner, measured at month 6 via electronic survey (about the previous 3 months, i.e., timeframe between months 3-6).|month 6|Of control participants, only 104 of 115 provided data for this outcome. Of intervention participants, only 90 of 98 provided data for this outcome.|||Participants|||Count of Participants
2573434|NCT02494817|Secondary|Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3|Self-reports of yes/no of any anal sex with casual male sex partner between months and month 3 via electronic survey|3 month|9 of 125 participants in control did not provide data, and 9 of 92 participants in intervention did not provide data.|||Participants|||Count of Participants
2573435|NCT02494817|Secondary|Adherence to a Sexual Agreement|Self-reports of yes/no to adhering to a sexual agreement via electronic survey|3 month|Participants who provided data in outcome 3 as having a concordant agreement were analyzed.|||Participants|||Count of Participants
2573436|NCT02494817|Secondary|Formation of a Sexual Agreement at 3 Months|Self-reports of yes/no to forming a sexual agreement via electronic survey|3 month|206 partnered men represent 44 dyads in the intervention arm and 59 dyads in the control arm, respectively. Couple-level findings are reported at the individual level.|||Participants|||Count of Participants
2573437|NCT02494817|Primary|Adherence to a Sexual Agreement at 6 Months|Self-report of yes/no of adhering to a sexual agreement|6 month|Participants who provided data in outcome 1 as having a concordant agreement were analyzed.|||Participants|||Count of Participants
2573438|NCT02494817|Primary|Formation of a Sexual Agreement at 6 Months|Self-reports of yes/no to forming a sexual agreement via electronic survey|6 month|"For control, 115 men (52 dyads both partners provided data and 11 dyads where only one partner provided data) provided outcome data.~For intervention, 98 men (45 dyads where both partners provided data and 8 dyads where only one partner provided data) provided outcome data.~Only dyads where both partners provided data were included."|||Participants|||Count of Participants
2573439|NCT02494713|Secondary|Surgical Morbidity as Measured by Number of Adverse Events|Number of adverse events was measured as a count of all participant adverse events that occurred from the time participant first initiates ADT plus chemotherapy until the participant was taken off-study or the study was stopped, an average of 20 months|From the time the participant signs the informed consent until the participant was taken off-study or the study was stopped, an average of 20 months||||adverse event|||Number
2573440|NCT02494713|Secondary|Safety of Drug Regimen as Measured by Number of Adverse Events|Number of adverse events was measured as a count of all participant adverse events that occurred from the time participant first initiates ADT plus chemotherapy until participant's completion of neoadjuvant ADT plus chemotherapy.|From the time participant first initiates ADT plus chemotherapy until participant's completion of neoadjuvant ADT plus chemotherapy.||||adverse event|||Number
2573441|NCT02494713|Secondary|Efficacy as Measured by Volume of the Prostate Tumor as Assessed by Multiparametric Prostate Magnetic Resonance Imaging (mpMRI)|The volume of the prostate tumor was measured by a radiologist's assessment of multiparametric prostate magnetic resonance imaging.|post treatment but prior to prostatectomy (about 25 days after the end of treatment)||||cc||Full Range|Median
2573442|NCT02494713|Secondary|Efficacy as Measured by Volume of the Prostate Tumor as Assessed by Multiparametric Prostate Magnetic Resonance Imaging (mpMRI)|The volume of the prostate tumor was measured by a radiologist's assessment of multiparametric prostate magnetic resonance imaging.|baseline||||cc||Full Range|Median
2573443|NCT02494713|Secondary|Efficacy as Measured by Circulating Tumor Cell (CTC) Numbers||From the time the participant signs the informed consent until prostatectomy, an average of 5 months.|This data was not collected for any participants.||||||
2573444|NCT02494713|Secondary|Efficacy as Measured by Prostate-specific Antigen (PSA) Levels|Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.|about 68 weeks after treatment initiation (about 48 weeks after prostatectomy)|This data was collected for only 3 out of the 4 participants.|||ng/mL||Full Range|Median
2573445|NCT02494713|Secondary|Efficacy as Measured by Prostate-specific Antigen (PSA) Levels|Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.|about 44 weeks after treatment initiation (about 24 weeks after prostatectomy)|This data was only collected for 3 out of the 4 participants.|||ng/mL||Full Range|Median
2573446|NCT02494713|Secondary|Efficacy as Measured by Prostate-specific Antigen (PSA) Levels|Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.|about 32 weeks after treatment initiation (about 12 weeks after prostatectomy)||||ng/mL||Full Range|Median
2573447|NCT02494713|Secondary|Efficacy as Measured by Prostate-specific Antigen (PSA) Levels|Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.|about 20 weeks after treatment initiation (day of prostatectomy)||||ng/mL||Full Range|Median
2573448|NCT02494713|Secondary|Efficacy as Measured by Prostate-specific Antigen (PSA) Levels|Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.|Day 133, about 19 weeks after treatment initiation (but before prostatectomy)||||ng/mL||Full Range|Median
2573449|NCT02494713|Secondary|Efficacy as Measured by Prostate-specific Antigen (PSA) Levels|Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.|Cycle 2 Day 57, about 16 weeks after treatment initiation (but before prostatectomy)||||ng/mL||Full Range|Median
2573450|NCT02494713|Secondary|Efficacy as Measured by Prostate-specific Antigen (PSA) Levels|Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.|Cycle 2 Day 1, about 8 weeks after treatment initiation (but before prostatectomy)||||ng/mL||Full Range|Median
2573451|NCT02494713|Secondary|Efficacy as Measured by Prostate-specific Antigen (PSA) Levels|Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are reported as nanograms of PSA per milliliter (ng/mL) of blood.|baseline||||ng/mL||Full Range|Median
2573452|NCT02494713|Primary|Efficacy as Measured by Pathologic Response|Pathologic response is defined by percentage of tumor burden remaining at time of prostate removal. Percentage of tumor burden is measured based on a pathologist's assessment of the prostate tissue removed and visual estimate of how much tumor there is in the prostate.|Day of prostate removal, which is about 5 months following the day participant signed consent.||||percentage of tumor burden remaining||Full Range|Median
2573453|NCT02494596|Secondary|Time to Maximum Plasma Concentration of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab|Capecitabine is a novel oral fluoropyrimidine carbamate that is preferentially converted to the cytotoxic moiety fluorouracil (5-fluorouracil; 5-FU) in target tumour tissue through a series of 3 metabolic steps through the intermediate metabolites 5'-deoxy-5-fluorocytidine (5'-DFCR), 5'-deoxy-5-fluorouridine (5'-DFUR), and α-fluoro-β-alanine (FBAL). Tmax is defined as the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination.|Day -7: Predose, 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours postdose; Cycle 1 Day 1: Predose, 0 and 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours Postdose|ITT population|||hours||Standard Deviation|Mean
2573454|NCT02494596|Secondary|Maximum Plasma Concentration of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab|Capecitabine is an oral fluoropyrimidine carbamate that is preferentially converted to the cytotoxic moiety 5-FU in target tumour tissue through a series of 3 metabolic steps through the intermediate metabolites 5'-DFCR, 5'-DFUR, and FBAL. Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose and is measures as nanograms per milliliter (ng/mL).|Day -7: Predose, 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours postdose; Cycle 1 Day 1: Predose, 0 and 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours Postdose|ITT population|||ng/mL||Standard Deviation|Mean
2573455|NCT02494596|Secondary|Plasma Half-Life of Capecitabine and it's Metabolites When Given Alone and in Combination With Pertuzumab|Capecitabine is a novel oral fluoropyrimidine carbamate that is preferentially converted to the cytotoxic moiety fluorouracil (5-fluorouracil; 5-FU) in target tumour tissue through a series of 3 metabolic steps through the intermediate metabolites 5'-deoxy-5-fluorocytidine (5'-DFCR), 5'-deoxy-5-fluorouridine (5'-DFUR), and α-fluoro-β-alanine (FBAL). The biological half-life or terminal half-life is the time in days it takes for it to lose half of its pharmacologic activity.|Day -7: Predose, 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours postdose; Cycle 1 Day 1: Predose, 0 and 30 minutes, 1, 2, 3, 4, 5, 6 and 10 hours Postdose|ITT population|||hours||Standard Deviation|Mean
2573456|NCT02494596|Secondary|Apparent Total Clearance of Pertuzumab|Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per day (mL/day).|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population|||mL/day||Standard Deviation|Mean
2573457|NCT02494596|Secondary|Apparent Volume of Distribution of Pertuzumab|The volume of distribution at steady state (Vss), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. Vss was measured in mL|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population|||mL||Standard Deviation|Mean
2573458|NCT02494596|Secondary|AUC From Time Zero to Infinity (AUC 0-infinity) of Pertuzumab|The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as nanograms times days per milliliter (ng*day/mL).|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population|||ng*day/mL||Standard Deviation|Mean
2573459|NCT02494596|Secondary|Area Under the Concentration Curve From Time Zero to Last Measurement (AUC 0-last) of Pertuzumab|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-last is calculated from time 0 (prior to administration of medication) to last measured data point. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC was measured as ng*day/mL.|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population|||ng*day/mL||Standard Deviation|Mean
2573460|NCT02494596|Secondary|Time to Maximum Plasma Concentration (Tmax) of Pertuzumab|Tmax is defined as the time after administration of a drug when the maximum plasma concentration is reached; when the rate of absorption equals the rate of elimination. Tmax was measured in days.|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population|||days||Standard Deviation|Mean
2573461|NCT02494596|Secondary|Maximum Plasma Concentration (Cmax) of Pertuzumab|Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose and was measured as nanograms per milliliter (ng/mL).|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and predose on Days 8, 15 and 22|ITT population|||ng/mL||Standard Deviation|Mean
2573462|NCT02494596|Secondary|Plasma Half-Life (t1/2) of Pertuzumab|The biological half-life or terminal half-life of pertuzumab is the time in days it takes for it to lose half of its pharmacologic activity. t1/2 was measured in days.|Cycle 1: Days 2, 5, 8 and 15 Postdose; Cycle 2: Day 1 at drug administration, predose and 15 minutes postdose, and Predose on Days 8, 15 and 22|ITT population|||days||Standard Deviation|Mean
2573463|NCT02494596|Secondary|Percentage of Participants With DLTs|DLTs were defined as follows: 1)Any non-hematological toxicity greater than or equal to (≥) Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management; 2) Grade 4 neutropenia lasting > 7 days; 3) Febrile neutropenia; 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion; 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds. Participants who withdrew from the study without completing the first treatment cycle for reasons other than DLT were not considered evaluable for DLT.|Cycle 1 (3 Weeks)|Safety population|||percentage of participants|||Number
2573464|NCT02494596|Primary|Maximum Tolerated Dose (MTD) of the Combination of Pertuzumab and Capecitabine|MTD was defined as the highest tolerated dose combination of capecitabine (825 mg, 1000 mg or 1250 mg) and pertuzumab, without causing Dose Limiting Toxicities (DLTs). DLTs were defined as follows: 1) Any non-hematological toxicity greater than or equal to (≥) Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management; 2) Grade 4 neutropenia lasting > 7 days; 3) Febrile neutropenia; 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion; 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds. Participants who withdrew from the study without completing the first treatment cycle for reasons other than DLT were not considered evaluable for DLT. MTD was measured in mg/m^2.|Cycle 1 (3 Weeks)|The Safety Population included all participants who received any amount of study medication and who had at least one post-baseline safety follow-up.|||mg/m^2|||Number
2573465|NCT02494583|Secondary|Number of Participants Discontinuing Study Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an adverse event. The number of participants who discontinued study treatment due to an AE was reported for each arm according to the treatment received.|Up to approximately 28.5 months|All randomized participants who received at least 1 dose of trial treatment were analyzed.|||Participants|||Count of Participants
2573466|NCT02494583|Secondary|Number of Participants Experiencing an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an adverse event. The number of participants who experienced an AE was reported for each arm according to the treatment received.|Up to approximately 31.5 months|All randomized participants who received at least 1 dose of trial treatment were analyzed.|||Participants|||Count of Participants
2573467|NCT02494583|Secondary|Pembro Combo vs. SOC: Change From Baseline to Week 18 in EORTC QLQ-STO22 Pain Symptom Subscale Score|EORTC-QLQ-STO22 is a 22-item questionnaire developed to assess QoL of gastric cancer participants. It consists of 5 multi-item subscales that assess dysphagia (3 items), dietary restriction (4 items), pain (4 items), upper gastro-esophageal symptoms (3 items), and emotional problems (3 items), and questions on dry mouth, taste, body image, and hair loss. Participant responses to the Pain symptom subscale (Items 34-37) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. Per protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared between the pembro combo arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared separately between the pembro mono arm and SOC arm and is presented earlier in the record.|Baseline, Week 18|Participants in the pembro combo arm and SOC arm who received ≥1 dose of study drug and who had EORTC-QLQ-STO22 assessments available at baseline or post-baseline up to Week 18. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2573468|NCT02494583|Secondary|Pembro Mono vs. SOC: Change From Baseline to Week 18 in EORTC QLQ-Module for Gastric Cancer (STO22) Pain Symptom Subscale Score|EORTC-QLQ-STO22 is a 22-item questionnaire developed to assess QoL of gastric cancer participants. It consists of 5 multi-item subscales that assess dysphagia (3 items), dietary restriction (4 items), pain (4 items), upper gastro-esophageal symptoms (3 items), and emotional problems (3 items), and questions on dry mouth, taste, body image, and hair loss. Participant responses to the Pain symptom subscale (Items 34-37) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. Per protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared between the pembro mono arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared separately between the pembro combo arm and SOC arm and is presented later in the record.|Baseline, Week 18|Participants in the pembro mono arm and SOC arm who received ≥1 dose of study drug and who had EORTC-QLQ-STO22 assessments available at baseline or post-baseline up to Week 18. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2573469|NCT02494583|Secondary|Pembro Combo vs SOC: Change From Baseline to Week 18 in the EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score|"The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the GHS question How would you rate your overall health during the past week? (Item 29) and the QoL question How would you rate your overall quality of life during the past week? (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro combo arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro mono arm and SOC arm and is presented earlier in the record."|Baseline, Week 18|Participants in the pembro combo arm and SOC arm who received ≥1 dose of study drug and who had EORTC-QLQ-C30 assessments available at baseline or post-baseline up to Week 18. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2573470|NCT02494583|Secondary|Pembro Mono vs SOC: Change From Baseline to Week 18 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score|"The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question How would you rate your overall health during the past week? (Item 29) and the Quality of Life (QoL) question How would you rate your overall quality of life during the past week? (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared between all participants of the pembro mono arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro combo arm and SOC arm and is presented later in the record."|Baseline, Week 18|Participants in the pembro mono arm and SOC arm who received ≥1 dose of study drug and who had EORTC-QLQ-C30 assessments available at baseline or post-baseline up to Week 18. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2573488|NCT02494518|Primary|Wolf Motor Function Test|Motor test to assess arm function. The reported data is the change in total Functional Ability Score. Scores range from 0-75 and higher scores represent improved function.|Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends|One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4|||units on a scale||Standard Deviation|Mean
2573694|NCT02492295|Secondary|Hypotension: Blood Pressure of < 100/60|Blood pressure of < 100/60 up to 60 minutes after propofol administration or until patient is fully alert.|60 minutes|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2573471|NCT02494583|Secondary|Pembro Mono vs SOC: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)|"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro mono arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. PFS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record."|Up to approximately 42 months (through Final Analysis cut-off date of 26-Mar-2019)|All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2573472|NCT02494583|Secondary|Pembro Mono vs SOC: DOR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)|For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants) and had CR or PR. Per protocol, DOR was compared separately between CPS ≥1 responders of the pembro combo arm and SOC arm and is presented earlier in the record.|Up to approximately 42 months (through Final Analysis cut-off date of 26-Mar-2019)|All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm and who demonstrated a confirmed CR or PR were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.|||Months||Full Range|Median
2573473|NCT02494583|Secondary|Pembro Mono vs SOC: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)|ORR was defined as the percentage of participants in the analysis population who have a CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro mono arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record.|Up to approximately 42 months (through Final Analysis cut-off date of 26-Mar-2019)|All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2573474|NCT02494583|Secondary|Pembro Combo vs SOC: Duration of Response (DOR) Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)|For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based upon BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants) and had CR or PR. Per protocol, DOR was compared separately between CPS ≥1 responders of the pembro mono arm and SOC arm and is presented later in the record.|Up to approximately 42 months (through Final Analysis cut-off date of 26-Mar-2019)|All CPS ≥1 participants in the ITT population randomized to the pembro combo arm and SOC arm and who demonstrated a confirmed CR or PR were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.|||Months||Full Range|Median
2573475|NCT02494583|Secondary|Pembro Combo vs SOC: Objective Response Rate (ORR) Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)|ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro combo arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record.|Up to approximately 42 months (through Final Analysis cut-off date of 26-Mar-2019)|All CPS ≥1 participants in the ITT population randomized to the pembro combo arm and SOC arm were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2573476|NCT02494583|Primary|Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥10|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro mono arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥10. Per protocol, OS was compared separately between CPS ≥10 participants of the pembro combo arm and SOC arm and is presented earlier in the record.|Up to approximately 42 months (through Final Analysis cut-off date of 26-Mar-2019)|All CPS ≥10 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2573477|NCT02494583|Primary|Pembro Mono vs SOC: OS in Participants With PD-L1 CPS ≥1 (All Participants)|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro mono arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, OS was compared separately between CPS ≥1 participants of the pembro combo arm and SOC arm and is presented earlier in the record.|Up to approximately 42 months (through Final Analysis cut-off date of 26-Mar-2019)|All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2573478|NCT02494583|Primary|Pembro Combo vs SOC: OS in Participants With PD-L1 CPS ≥10|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥10. Per protocol, OS was compared separately between CPS ≥10 participants of the pembro mono arm and SOC arm and is presented later in the record.|Up to approximately 42 months (through Final Analysis cut-off date of 26-Mar-2019)|All CPS ≥10 participants in the ITT population randomized to the pembro combo arm and SOC arm were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2573479|NCT02494583|Primary|Pembro Combo vs SOC: Overall Survival (OS) in Participants With PD-L1 CPS ≥1 (All Participants)|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, OS was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record.|Up to approximately 42 months (through Final Analysis cut-off date of 26-Mar-2019)|All CPS ≥1 participants in the ITT population randomized to the pembro combo arm and SOC arm were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2573480|NCT02494583|Primary|Pembro Combo vs SOC: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1 (All Participants)|"PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the Intent-To-Treat (ITT) population. PFS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later in the record."|Up to approximately 36 months (through Interim Analysis cut-off date of 26-Sep-2018)|All CPS ≥1 participants in the ITT population randomized to the pembro combo arm and SOC arm were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2573481|NCT02494518|Secondary|Six Minute Walk Test|Distance walked in 6 minutes to measure cardiovascular fitness. The reported data is change in total distance traveled.|Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends|Two individuals in FE+RTP did not complete this assessment at EOT+4|||feet||Standard Deviation|Mean
2573482|NCT02494518|Secondary|Nine Hole Peg Test|Transferring pegs into a fitted hole to measure hand function. The reported data is change in average time to complete.|Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends|One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4. One individual in VE+RTP did not complete the NHPT at EOT+4.|||seconds||Standard Deviation|Mean
2573483|NCT02494518|Secondary|Processing Speed Test|Matching letters and symbols to test cognition. The reported data is change in total number correct.|Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends|One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4|||number correct||Standard Deviation|Mean
2573484|NCT02494518|Secondary|Center for Epidemiological Studies-Depression|Depression questionnaire. The reported data is change in total score. Scores range from 0-60, and lower scores indicate decreased risk of depression.|Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends|One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4|||units on a scale||Standard Deviation|Mean
2573485|NCT02494518|Secondary|Action Research Arm Test|Motor test to assess arm function. The reported data is change in total score. Scores range from 0-57, and higher scores indicate better function.|Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends|One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4|||units on a scale||Standard Deviation|Mean
2573486|NCT02494518|Primary|Metabolic Stress Test|Cycling test to measure cardiovascular fitness. The data reported is the change in VO2peak. Higher scores indicate higher aerobic capacities.|Change from baseline to follow up assessments at end of 8 week intervention||||mL/kg/min||Standard Error|Mean
2573487|NCT02494518|Primary|Stroke Impact Scale|Quality of life questionnaire. The reported data is the normalized Hand Function score. Scores range from 0-100, with higher scores indicating better perceived hand function.|Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends|One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4|||units on a scale||Standard Deviation|Mean
2573695|NCT02492295|Secondary|Hypoxia: SpO2 of <88%|SpO2 of <88% up to 60 minutes after propofol administration or until patient is fully alert.|60 minutes|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2573489|NCT02494518|Primary|Fugl Meyer Assessment|Motor test to assess arm impairment. The reported data is the change in total score. Score range from 0-66 and higher scores represent less impairment.|Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends|One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4|||units on a scale||Standard Deviation|Mean
2573490|NCT02494440|Secondary|Gestational Age Calculated by Femur Length Measurement by Five-Dimensional Ultrasound|"The femur length at Five-Dimensional Ultrasound: To obtain 3D volume data, the entire bone length of the femur was identified on the screen, as in the 2D-ultrasound measurement, and the long axis of the femur was placed in the direction of the x axis in the image in which the ultrasound beam was perpendicular to the bone. The 5D LB set key was pressed on the system, wherein the system automatically analyzed the 3D volume data, reconstructed the 3D image of the long bones, and displayed the measured length of the femur length on the screen was measured by pressing 5D LB Button to extract Fetal Long Bones automatically.~then, gestational Age Calculated by femur length measurement"|26 - 40 weeks of gestation|Ninety pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria|||weeks||Standard Deviation|Mean
2573491|NCT02494440|Secondary|Gestational Age Calculated by Femur Length Measurement by Two-Dimensional Ultrasound|"The femur length at Two-Dimensional Ultrasound (Gold standard) was made from the center of the 'U' shape at each end of the bone. After the long axis of the fetus was identified, the transducer was turned 90 degrees to produce a cross sectional image of fetal trunk, maintaining the 90 degrees angle until the lower spine and iliac crest were identified, then the transducer was rotated until a full femur was imaged. The femur length was measured from the center of the U shape at each end of the bone; this represented the length of the metaphysis).~then , Gestational Age Calculated by femur length measurement"|26 - 40 weeks of gestation|90 pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria|||weeks||Standard Deviation|Mean
2573492|NCT02494440|Primary|Gestational Age Calculated by Accurate Dates of the Last Menstrual Period|"The patient must be sure of her last normal menstrual period, last three regular cycles and no hormonal contraception before pregnancy.~Gestational age calculated by the last menstrual period"|26 - 40 weeks of gestation|90 pregnant women were recruited from the the Fetal Care Unit who fulfilled the inclusion criteria|||weeks||Standard Deviation|Mean
2573493|NCT02494401|Other Pre-specified|Change in PHQ-8|The Patient Health Questionnaire-8 (PHQ-8) is an 8-item questionnaire that is commonly used to measure depressive symptoms. A score of ≥10 is consistent with depressed mood with a score ranging from 0 to 24.|Baseline compared to 16 weeks and 6 months|Population analyzed at 6 months differs due to drop outs shown in participant flow table.|||units on a scale||Standard Deviation|Mean
2573494|NCT02494401|Secondary|Change in Sleep Disturbance Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure|Sleep disturbance domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much),this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.|Baseline compared to 16 weeks and 6 months|Population analyzed at 6 months differs due to drop outs shown in participant flow table.|||units on a scale||Standard Deviation|Mean
2573495|NCT02494401|Secondary|Change in Visual Analogue Scale Pain Intensity Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure|The visual analogue scale pain intensity in the PROMIS-29 Profile v2.0® is scored as 0 being no pain and 10 being the worst imaginable pain.|Baseline compared to 16 weeks and 6 months|Population analyzed at 6 months differs due to drop outs shown in participant flow table.|||units on a scale||Standard Deviation|Mean
2573496|NCT02494401|Secondary|Change Pain Interference Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure|Pain interference domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.|Baseline compared to 16 weeks and 6 months|Population analyzed at 6 months differs due to drop outs shown in participant flow table.|||units on a scale||Standard Deviation|Mean
2573497|NCT02494401|Secondary|Change in Fatigue Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure|Fatigue domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.|Baseline compared to 16 weeks and 6 months|Population analyzed at 6 months differs due to drop outs shown in participant flow table.|||units on a scale||Standard Deviation|Mean
2573498|NCT02494401|Secondary|Change in Depression Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure|Depression domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.|Baseline compared to 16 weeks and 6 months|Population analyzed at 6 months differs due to drop outs shown in participant flow table.|||units on a scale||Standard Deviation|Mean
2573499|NCT02494401|Secondary|Change in Anxiety Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure|Anxiety domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents worse symptomatology, a lower score represents better symptomatology.|Baseline compared to 16 weeks and 6 months|Population analyzed at 6 months differs due to drop outs shown in participant flow table.|||units on a scale||Standard Deviation|Mean
2573500|NCT02494401|Secondary|Change in Social Role Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure|Social role domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents better social role functioning and a lower score represents poorer social role functioning.|Baseline compared to 16 weeks and 6 months|Population analyzed at 6 months differs due to drop outs shown in participant flow table.|||units on a scale||Standard Deviation|Mean
2573501|NCT02494401|Secondary|Change in Physical Function Scale on the PROMIS® 29 Profile v 2.0 Outcome Measure|Physical Function domain in the PROMIS-29 Profile v2.0® are scored from 1 (unable to do/never/not at all) to 5 (without any difficulty/always/very much), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. A higher score represents better physical function, a lower score represents poorer physical function.|Baseline compared to 16 weeks and 6 months|Population analyzed at 6 months differs due to drop outs shown in participant flow table.|||units on a scale||Standard Deviation|Mean
2573502|NCT02494401|Secondary|Change in Managing Social Interactions Scale on the PROMIS® Self-efficacy Short Form 8|Managing Social Interactions score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms.|Baseline compared to 16 weeks and 6 months|Population analyzed at 6 months differs due to drop outs shown in participant flow table.|||units on a scale||Standard Deviation|Mean
2573503|NCT02494401|Secondary|Change in Managing Medications and Treatment Scale on the PROMIS® Self-efficacy Short Form 8|Managing Medication and Treatment score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms.|Baseline compared to 16 weeks and 6 months|Population analyzed at 6 months differs due to drop outs shown in participant flow table.|||units on a scale||Standard Deviation|Mean
2573504|NCT02494401|Secondary|Change in Managing Emotions Scale on the PROMIS® Self-efficacy Short Form 8|Managing Emotions score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms.|Baseline compared to 16 weeks and 6 months|Population analyzed at 6 months differs due to drop outs shown in participant flow table.|||units on a scale||Standard Deviation|Mean
2573505|NCT02494401|Secondary|Change in Managing Daily Activities Scale on the PROMIS® Self-efficacy Short Form 8|Managing Daily Activities score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms.|Baseline compared to 16 weeks and 6 months|Population analyzed at 6 months differs due to drop outs shown in participant flow table.|||units on a scale||Standard Deviation|Mean
2573506|NCT02494401|Secondary|Change in Brief Satisfaction on the Satisfaction With Appearance Scale (SWAP) Scale|The Brief Satisfaction with Appearance Scale (SWAP) is a 6-item scale measuring body image concerns and social discomfort with body parts. It is scored from 0 to 36, with higher scores associated with greater dissatisfaction.|Baseline compared with 16 weeks, 6 months|Population analyzed at 6 months differs due to drop outs shown in participant flow table.|||units on a scale||Standard Deviation|Mean
2573507|NCT02494401|Secondary|Change in Confidence in Self Management on the Patient Activation Measure Scale|"The Patient Activation Measure (PAM) is a 13-item measure that assesses patient knowledge, skill, and confidence for self-management. Each item is scored from 1 (strongly disagree) to 4 (strongly agree). PAM scores were categorized into 4 levels: level 1, the individual is disengaged/overwhelmed; level 2, the individual is aware but struggling; level 3, the individual is taking action;and level 4, the individual is maintaining behavior. The analysis will look at any change in these levels where level 4 denotes someone as full activated."|Baseline compared with 16 weeks, 6 months|Population analyzed at 6 months differs due to drop outs shown in participant flow table.|||PAM level||Standard Deviation|Mean
2573508|NCT02494401|Secondary|Change in Quality of Life on the European Quality of Life-5 Dimensions (EQ-5D) Index Scale|EQ-5D index scale uses a conversion algorithm to convert the raw scores into a health utility measure, ranging from 0.0 (death) to 1.0 (full or optimal health).|Baseline compared with 16 weeks, 6 months|Population analyzed at 6 months differs due to drop outs shown in participant flow table.|||units on a scale||Standard Deviation|Mean
2573509|NCT02494401|Primary|Change in Managing Symptoms Scale on the PROMIS® Self-efficacy Short Form 8|Managing Symptoms score on the PROMIS® Self-efficacy Short Form 8 consists of 8 items scored from 1 (not at all confident) to 5 (very confident), this provides a raw score. The raw score is translated to a T-Score using a conversion table supplied by the Assessment Center. A score of 50 is the average for the US general population with a standard deviation of 10. Higher scores are indicative of greater ability to manage symptoms.|Baseline compared with 16 weeks, 6 months|Population analyzed at 6 months differs due to drop outs shown in participant flow table.|||units on a scale||Standard Deviation|Mean
2573510|NCT02494336|Secondary|Number of Complications|Such as infection, bleeding, intravascular injection, bowel puncture|30 days|||||||
2573511|NCT02494336|Secondary|Number of Participants With Complications|Complications such as infection, bleeding, intravascular injection, bowel puncture|30 days|||||||
2573512|NCT02494336|Secondary|Number of Participants With Side Effects|Such as nausea, vomiting, allergic reactions|5 days|||||||
2573513|NCT02494336|Secondary|Time to First Rescue Analgesic|Amount of time in minutes until the first analgesic is given postoperatively|1 day||2020-03-31|03/2020||||
2573516|NCT02494336|Primary|Post Operative Pain Rating|"Using the Wong-Baker FACES Pain Rating Scale (WBFPRS). The WBFPRS is a visual pain rating scale in which the participant looks at pictures of faces depicting levels of pain and chooses the one that most closely resembles their own pain. The scale ranges from 0 no hurt to 10 Hurts Worst."|5 days||||score on a scale||Standard Deviation|Mean
2573517|NCT02494323|Secondary|Benefit Satisfaction Willingness to Continue (BSW) Questionnaire|Number of subjects who benefited or not benefited from the dual channel electrode was counted, number of patients who were satisfied or not satisfied with the dual channel electrode was counted, number of subjects who were willing to continue or who were unwilling to continue with the dual channel electrode was counted|7 months|Five subjects were excluded from filling up the BSW questionnaire, since the Segmented Electrode (SE) did not produce motor reaction in the ankle|||participants|||Number
2573518|NCT02494323|Primary|Ankle Movement as Good as or Better With the Segmented Electrode as With the QFE|Subjects were fitted with the L300 Cuff that houses the single channel QFE and then the modified cuff that houses the dual channel segmented electrode. Subjects were stimulated first sitting and then after optimal ankle elevation was achieved, they walked with the stimulation. The clinician documented ankle movement on a 5 point scale: 1-inverted dorsiflexion, 2-slightly inverted dorsiflexion, 3-neutral dorsiflexion,4- slightly everted dorsiflexion, 5- everted dorsiflexion. The clinician documented the number of subjects who achieved each movement with each electrode according to the 5 point scale.|7 months|All subjects suffer from foot drop due to upper motor neuron lesion|||units on a scale||Standard Deviation|Mean
2573519|NCT02494206|Primary|Volume Changes as Measured by Perometry|"Therapeutic volume changes in the arm will be calculated using the methods published by Anderson et al (2000).65 Briefly, the difference in volume measurements between the normal and lymphedematous arms at baseline (i.e volume excess) will be compared to the volume differential after drug treatment and following the washout period using the following formula:~(VL-VN) B - (VL-VN) F"|1 year|Data were not collected||||||
2573520|NCT02494180|Secondary|Sedation Level|S = sleeping, easily aroused; 1 = awake and alert; 2 = occasionally drowsy, easy to arouse; 3 = frequently drowsy, arousable, drifts off to sleep during conversation; 4 = somnolent, minimal or no response to stimuli|immediately after retrieval||||Participants|||Count of Participants
2573521|NCT02494180|Secondary|Patient's Satisfaction on Pain Relief|satisfaction on pain relief will be scored at 0-10 (10 being most satisfied)|within 4 hours after retrieval||||score on a scale||Inter-Quartile Range|Median
2573522|NCT02494180|Secondary|Ongoing Pregnancy Rate|positive fetal heart pulsation seen in ultrasound at eight weeks of gestation|will be assessed within ten weeks of oocyte retrieval||||percentage of participants|||Number
2573523|NCT02494180|Secondary|Clinical Pregnancy Rate|presence of intrauterine sac in ultrasound after a positive pregnancy test|will be assessed within ten weeks of oocyte retrieval||||percentage of participants|||Number
2573524|NCT02494180|Secondary|Patient's Satisfaction on Oocyte Retrieval|satisfaction will be scored from 0-3 (0=excellent, 1=satisfactory, 2=fair, 3=unsatisfactory)|will be assessed within 4 hours of oocyte retrieval||||percentage of participants|||Number
2573525|NCT02494180|Secondary|Percentage of Participants With Side Effects by Type|side effects will be scored by yes or no|will be assessed within 4 hours of oocyte retrieval||||percentage of participants|||Number
2573526|NCT02494180|Primary|Pain Level After Oocyte Retrieval|The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful|will be assessed within 4 hours of oocyte retrieval||||score on a scale||Inter-Quartile Range|Median
2573527|NCT02494180|Primary|Pain Level During Oocyte Retrieval|The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful|will be assessed within 4 hours of oocyte retrieval||||score on a scale||Inter-Quartile Range|Median
2573528|NCT02494102|Secondary|Postanesthesia Quality Recovery Scale Score|Postanesthesia quality recovery scale (PQRS). Component and aggregate scoring on the scale. Measures physiology, nociceptive, emotional activities of daily living cognitive and overall patient perspective. The scale is dimensionless and the aggregate of all individually tested dimensions is scaled from 17-65. A higher value implies improved postanesthesia recovery. Mean difference was assessed in each patient and aggregated thus patients with no difference between pre- and post-operative scores were zeroed (received a zero score if the difference was zero). A negative value was associated with worse outcome.|baseline and 6 hours after surgery|16 patients violated study protocol and were excluded|||units on a scale||Standard Deviation|Mean
2573529|NCT02494102|Primary|Length of Time From Extubation to Discharge From Postanesthesia Recovery Unit|Length of time of above compared between groups|24 hours|16 participants violated the study protocol|||minutes||Inter-Quartile Range|Mean
2573530|NCT02494076|Secondary|Rate of Inpatient Hospitalization|Number of patients in each group requiring hospital admission|After intervention or control and until follow-up phone call 72 hours after disposition|2 patients excluded due to missing data and protocol error|||Participants|||Count of Participants
2573531|NCT02494076|Secondary|Number of Participants Requiring Second Line Therapies Including Continuous Albuterol, Subcutaneous Terbutaline, IV Magnesium and Supplemental Oxygen After Administration of Intervention or Control|Second line therapies include: continuous albuterol, intravenous magnesium sulfate, subcutaneous or intravenous terbutaline, non-invasive ventilation (BiPAP or CPAP), and supplemental oxygen. The need for these second line therapies will be assessed by the child's treating team in the Emergency Department.|participants will be followed for the duration of ED stay, an expected average of 6-8 hours|2 subjects excluded from analysis due to missing data|||Participants|||Count of Participants
2573550|NCT02493946|Primary|The Percentage of Responders at Day 29 Cycle 1 as Measured by Investigator's Live Assessment (ILA) of Glabellar Lines at Maximum Frown: DB Period|The appearance of glabellar lines at maximum frown was assessed in the DB period at the Day 29 follow-up visit using the ILA, a validated 4-point photographic scale of glabellar line severity. A responder was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at baseline (Day 1 Cycle 1). The adjusted percentage of responders (determined by multivariate logistic regression analysis) at Day 29 of Cycle 1 is presented.|Day 29 (Cycle 1)|The modified intent-to-treat (mITT) population which consisted of all subjects who were randomised, received study treatment (BTX-A-HAC solution or placebo) and completed one post-treatment assessment of the ILA of glabellar lines at maximum frown.|||Adjusted Percentage of Responders||95% Confidence Interval|Number
2573532|NCT02494076|Primary|Change in Pulmonary Asthma Score (PAS)|The primary outcome was the change in asthma severity as determined by change in Pulmonary Asthma Score (PAS) before and after administration of intervention (or control). The same trained, blinded physician assessor, who was not involved in the care of the patient, assessed PAS scores for study subjects before intervention (or control), and 15 minutes after completion of administration. The PAS is a pediatric asthma severity scoring system adapted from previously validated scores, and includes measures of respiratory rate, oxygen saturation, auscultory findings, retractions, and dyspnea. Values from each category are summed producing a total score between 5 and 15. Total scores < 7 correspond with mild asthma exacerbations, while scores ≥ 7 and < 12 indicate moderate asthma, and scores ≥12 to 15 indicate severe asthma. The primary outcome was determined by subtracting the post-intervention score from the pre-intervention score.|0-30 minutes|2 patients in EzPAP group were excluded from analysis due to protocol error and missing data.|||mean PAS score||Standard Deviation|Mean
2573533|NCT02493946|Secondary|Change From Baseline at All Post-treatment Visits in the FACE-Q Aging Appearance Appraisal VAS: LT Analyses|FACE-Q is a subject-reported outcome instrument to evaluate the experience and outcomes of aesthetic facial procedures from the subject's perspective. One of three scales that was selected for this study was the aging appearance appraisal VAS. The VAS ranged from -15 ('I look 15 years younger') to +15 ('I look 15 years older'), with 0 indicating 'I look my age'. Subjects were asked to circle one number on the VAS indicating how many years younger or older they thought they looked compared to their actual age, with lower scores indicating a better outcome and higher scores a worse outcome. The mean change from baseline at post-treatment visits is presented.|Days 8, 29, 57 and 85 of Cycles 1 to 3; Days 8, 29 and 85 of Cycles 4 and 5.|The LTA population consisted of all subjects included in the DB period or as de novo subjects in the OL period who received at least one injection of BTX-A-HAC solution in the OL period. Only subjects with data available at the timepoints of testing are presented.|||Scores on a Scale||Standard Deviation|Mean
2573534|NCT02493946|Secondary|Change From Baseline at All Post-treatment Visits in the FACE-Q Psychological Well-being Scale: LT Analyses|FACE-Q is a subject-reported outcome instrument to evaluate the experience and outcomes of aesthetic facial procedures from the subject's perspective. One of three scales that was selected for this study was the psychological well-being scale. This consisted of 10 items with 4 possible answers for each: 1 (Definitely disagree), 2 (Somewhat disagree), 3 (Somewhat agree) and 4 (Definitely agree). The mean change from baseline at post-treatment visits of Rasch transformed scores is presented. The Rasch transformed score was calculated by adding the 10 items (scored from 1 to 4) and converting the score to a scale from 0 (worst) to 100 (best) using a conversion table.|Days 8, 29, 57 and 85 of Cycles 1 to 3; Days 8, 29 and 85 of Cycles 4 and 5.|The LTA population consisted of all subjects included in the DB period or as de novo subjects in the OL period who received at least one injection of BTX-A-HAC solution in the OL period. Only subjects with data available at the timepoints of testing are presented.|||Scores on a Scale||Standard Deviation|Mean
2573535|NCT02493946|Secondary|Change From Baseline at All Post-treatment Visits in the FACE-Q Satisfaction With Facial Appearance Overall Scale: LT Analyses|FACE-Q is a subject-reported outcome instrument to evaluate the experience and outcomes of aesthetic facial procedures from the subject's perspective. One of three scales that was selected for this study was the satisfaction with facial appearance overall scale. This consisted of 10 items with 4 possible answers for each: 1 (Very Dissatisfied), 2 (Somewhat Dissatisfied), 3 (Somewhat Satisfied) and 4 (Very Satisfied). The mean change from baseline at post-treatment visits of Rasch transformed scores is presented. The Rasch transformed score was calculated by adding the 10 items (scored from 1 to 4) and converting the score to a scale from 0 (most dissatisfied) to 100 (most satisfied) using a conversion table.|Days 8, 29, 57 and 85 of Cycles 1 to 3; Days 8, 29 and 85 of Cycles 4 and 5.|The LTA population consisted of all subjects included in the DB period or as de novo subjects in the OL period who received at least one injection of BTX-A-HAC solution in the OL period. Only subjects with data available at the timepoints of testing are presented.|||Scores on a Scale||Standard Deviation|Mean
2573536|NCT02493946|Secondary|Median Time to Retreatment in LT Analysis|"The median time to onset of the next eligible treatment cycle is presented for Cycles 1 to 4.~Cycle 1 corresponds to the first administration of BTX-A-HAC solution and includes the DB Cycle 1 of subjects who were treated with BTX-A-HAC solution, the Cycle 1 of de novo subjects and Cycle 2 of subjects who were randomised to receive placebo in the DB period.~Subjects who were not subsequently retreated after a given cycle were excluded from the summary of time to retreatment at that cycle."|Cycles 1 - 4 (up to 12 months).|The LTA population consisted of all subjects included in the DB period or as de novo subjects in the OL period who received at least one injection of BTX-A-HAC solution in the OL period. Only subjects with data available at the timepoints of testing are presented.|||Days||95% Confidence Interval|Median
2573537|NCT02493946|Secondary|The Percentage of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Level of Satisfaction With the Appearance of Their Glabellar Lines: LT Analyses|The subject's level of satisfaction with the appearance of their glabellar lines was assessed in the OL period at post-treatment follow-up visits of each treatment cycle using a 4-point categorical scale. A responder was defined as having a satisfaction rating of very satisfied (Grade 0) or satisfied (Grade 1) at a given visit and a satisfaction rating of dissatisfied (Grade 2) or very dissatisfied (Grade 3) at baseline. The cycle baseline was defined as the last measurement collected prior to the study treatment injection of the corresponding cycle. The percentage of responders (unadjusted) at each post-treatment visit for Cycles 1 to 5 is presented. Cycle 1 corresponds to the first administration of BTX-A-HAC solution and includes the DB Cycle 1 of subjects who were treated with BTX-A-HAC solution, the Cycle 1 of de novo subjects and Cycle 2 of subjects who were randomised to receive placebo in the DB period.|Days 8, 29, 57 and 85 of Cycles 1 - 5 (up to 15 months).|The LTA population consisted of all subjects included in the DB period or as de novo subjects in the OL period who received at least one injection of BTX-A-HAC solution in the OL period. Only subjects with data available at the timepoints of testing are presented.|||Percentage of Responders||95% Confidence Interval|Number
2573625|NCT02493127|Primary|Difference in Grip Strength Measured With Dynamometer|Difference in Grip strength of both hands after completing intervention. Each participant completed the grip strength measurement 3 times with both hands at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.|Day 1||||pounds||Standard Deviation|Mean
2573538|NCT02493946|Secondary|The Percentage of Responders at Each Post-treatment Visit as Measured by the SSA at Maximum Frown: LT Analyses|The appearance of glabellar lines at maximum frown was assessed using the SSA, a validated 4-point categorical scale of glabellar line severity, in the OL period at post-treatment follow-up visits. A responder was defined as having a severity grade of no wrinkles (Grade 0) or mild wrinkles (Grade 1) at maximum frown at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) wrinkles at baseline. The cycle baseline was defined as the last measurement collected prior to the study treatment injection of the corresponding cycle. The percentage of responders (unadjusted) at each post-treatment visit for Cycles 1 to 5 is presented. Cycle 1 corresponds to the first administration of BTX-A-HAC solution and includes the DB Cycle 1 of subjects who were treated with BTX-A-HAC solution, the Cycle 1 of de novo subjects and Cycle 2 of subjects who were randomised to receive placebo in the DB period.|Days 8, 29, 57 and 85 of Cycles 1 - 5 (up to 15 months).|The LTA population consisted of all subjects included in the DB period or as de novo subjects in the OL period who received at least one injection of BTX-A-HAC solution in the OL period. Only subjects with data available at the timepoints of testing are presented.|||Percentage of Responders||95% Confidence Interval|Number
2573539|NCT02493946|Secondary|The Percentage of Responders at Each Post-treatment Visit as Measured by the ILA at Rest: LT Analyses|The appearance of glabellar lines at rest was assessed in the OL period at post-treatment follow-up visits using the ILA, a validated 4-point photographic scale of glabellar line severity. A responder was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at baseline. The cycle baseline was defined as the last measurement collected prior to the study treatment injection of the corresponding cycle. The percentage of responders (unadjusted) at each post-treatment visit for Cycles 1 to 5 is presented. Cycle 1 corresponds to the first administration of BTX-A-HAC solution and includes the DB Cycle 1 of subjects who were treated with BTX-A-HAC solution, the Cycle 1 of de novo subjects and Cycle 2 of subjects who were randomised to receive placebo in the DB period.|Days 8, 29, 57 and 85 of Cycles 1 - 5 (up to 15 months).|The LTA population consisted of all subjects included in the DB period or as de novo subjects in the OL period who received at least one injection of BTX-A-HAC solution in the OL period. Only subjects with data available at the timepoints of testing are presented.|||Percentage of Responders||95% Confidence Interval|Number
2573540|NCT02493946|Secondary|The Percentage of Responders at Each Post-treatment Visit as Measured by the ILA at Maximum Frown: LT Analyses|The appearance of glabellar lines at maximum frown was assessed in the OL period at post-treatment follow-up visits using the ILA, a validated 4-point photographic scale of glabellar line severity. A responder was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at baseline. The cycle baseline was defined as the last measurement collected prior to the study treatment injection of the corresponding cycle. The percentage of responders (unadjusted) at each post-treatment visit for Cycles 1 to 5 is presented. Cycle 1 corresponds to the first administration of BTX-A-HAC solution and includes the DB Cycle 1 of subjects who were treated with BTX-A-HAC solution, the Cycle 1 of de novo subjects and Cycle 2 of subjects who were randomised to receive placebo in the DB period.|Days 8, 29, 57 and 85 of Cycles 1 - 5 (up to 15 months).|The LTA population consisted of all subjects included in the DB period or as de novo subjects in the OL period who received at least one injection of BTX-A-HAC solution in the OL period. Only subjects with data available at the timepoints of testing are presented.|||Percentage of Responders||95% Confidence Interval|Number
2573541|NCT02493946|Secondary|Change From Baseline at All Post-treatment Visits in the FACE-Q Aging Appearance Appraisal Visual Analogue Scale (VAS): DB Period|FACE-Q is a subject-reported outcome instrument to evaluate the experience and outcomes of aesthetic facial procedures from the subject's perspective. One of three scales that was selected for this study was the aging appearance appraisal VAS. The VAS ranged from -15 ('I look 15 years younger') to +15 ('I look 15 years older'), with 0 indicating 'I look my age'. Subjects were asked to circle one number on the VAS indicating how many years younger or older they thought they looked compared to their actual age, with lower scores indicating a better outcome and higher scores a worse outcome. The least squares mean change from baseline at post-treatment visits is presented.|Baseline (Day 1) and Days 8, 29, 57 and 85 (Cycle 1).|The mITT population which consisted of all subjects who were randomised, received study treatment (BTX-A-HAC solution or placebo) and completed one post-treatment assessment of the ILA of glabellar lines at maximum frown. Only subjects with data available at the timepoints of testing are presented.|||Scores on a Scale||Standard Error|Least Squares Mean
2573542|NCT02493946|Secondary|Change From Baseline at All Post-treatment Visits in the FACE-Q Psychological Well-being Scale: DB Period|FACE-Q is a subject-reported outcome instrument to evaluate the experience and outcomes of aesthetic facial procedures from the subject's perspective. One of three scales that was selected for this study was the psychological well-being scale. This consisted of 10 items with 4 possible answers for each: 1 (Definitely disagree), 2 (Somewhat disagree), 3 (Somewhat agree) and 4 (Definitely agree). The least squares mean change from baseline at post-treatment visits of Rasch transformed scores is presented. The Rasch transformed score was calculated by adding the 10 items (scored from 1 to 4) and converting the score to a scale from 0 (worst) to 100 (best) using a conversion table.|Baseline (Day 1) and Days 8, 29, 57 and 85 (Cycle 1).|The mITT population which consisted of all subjects who were randomised, received study treatment (BTX-A-HAC solution or placebo) and completed one post-treatment assessment of the ILA of glabellar lines at maximum frown. Only subjects with data available at the timepoints of testing are presented.|||Scores on a Scale||Standard Error|Least Squares Mean
2573573|NCT02493764|Secondary|Percentage of Participants in the Microbiologically Evaluable (ME) Population With a FMR at EOT Visit|"The percentage of participants with a FMR at EOT was determined for each arm. Favorable microbiological response at EOT was defined as either eradication (a lower respiratory tract culture taken at EOT showing eradication of baseline pathogen) or presumed eradication (no specimen collected because the participant deemed clinically cured or improved)."|From Day 7 to Day 14|The ME population is all randomized participants with ≥1 dose of study therapy; not only gram-positive cocci on baseline Gram stain; IMI/REL-sensitive baseline pathogen as cause of HABP/VABP; met entry criteria; no protocol deviations; received minimum duration of IV therapy; have microbiological EOT data and LRT culture available.|||Percentage of participants|||Number
2573543|NCT02493946|Secondary|Change From Baseline at All Post-treatment Visits in the FACE-Q Satisfaction With Facial Appearance Overall Scale: DB Period|FACE-Q is a subject-reported outcome instrument to evaluate the experience and outcomes of aesthetic facial procedures from the subject's perspective. One of three scales that was selected for this study was the satisfaction with facial appearance overall scale. This consisted of 10 items with 4 possible answers for each: 1 (Very Dissatisfied), 2 (Somewhat Dissatisfied), 3 (Somewhat Satisfied) and 4 (Very Satisfied). The least squares mean change from baseline at post-treatment visits of Rasch transformed scores is presented. The Rasch transformed score was calculated by adding the 10 items (scored from 1 to 4) and converting the score to a scale from 0 (most dissatisfied) to 100 (most satisfied) using a conversion table.|Baseline (Day 1) and Days 8, 29, 57 and 85 (Cycle 1).|The mITT population which consisted of all subjects who were randomised, received study treatment (BTX-A-HAC solution or placebo) and completed one post-treatment assessment of the ILA of glabellar lines at maximum frown. Only subjects with data available at the timepoints of testing are presented.|||Scores on a Scale||Standard Error|Least Squares Mean
2573544|NCT02493946|Secondary|The Median Time to Onset of Treatment Response Based on the Subject's Diary Card: DB Period|Subjects were asked to record their assessment of study treatment response on a diary card on Days 1 to 7 at approximately the same time each day. Subjects were asked to respond 'yes' or 'no' to the following question: 'Since being injected have you noticed an improvement in the appearance of your glabellar lines (lines between your eyebrows)?' The time to onset of response was defined as the first day the subject responded 'yes' to this question.|Days 1 to 7 (Cycle 1).|The mITT population which consisted of all subjects who were randomised, received study treatment (BTX-A-HAC solution or placebo) and completed one post-treatment assessment of the ILA of glabellar lines at maximum frown.|||Days||95% Confidence Interval|Median
2573545|NCT02493946|Secondary|The Percentage of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Level of Satisfaction With the Appearance of Their Glabellar Lines: DB Period|The subject's level of satisfaction with the appearance of their glabellar lines was assessed in the DB period at post-treatment follow-up visits using a 4-point categorical scale. A responder was defined as having a satisfaction rating of very satisfied (Grade 0) or satisfied (Grade 1) at a given visit and a satisfaction rating of dissatisfied (Grade 2) or very dissatisfied (Grade 3) at baseline (Day 1 Cycle 1). The adjusted percentage of responders (determined by multivariate logistic regression analysis) at Days 8, 29, 57 and 85 of Cycle 1 is presented.|Days 8, 29, 57 and 85 (Cycle 1).|The mITT population which consisted of all subjects who were randomised, received study treatment (BTX-A-HAC solution or placebo) and completed one post-treatment assessment of the ILA of glabellar lines at maximum frown. Only subjects with data available at the timepoints of testing are presented.|||Adjusted Percentage of Responders||95% Confidence Interval|Number
2573546|NCT02493946|Secondary|The Percentage of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Self-Assessment (SSA) at Maximum Frown: DB Period|The appearance of glabellar lines at maximum frown was assessed using the SSA, a validated 4-point categorical scale of glabellar line severity, in the DB period at post-treatment follow-up visits. A responder was defined as having a severity grade of no wrinkles (Grade 0) or mild wrinkles (Grade 1) at maximum frown at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) wrinkles at baseline (Day 1 Cycle 1). The adjusted percentage of responders (determined by multivariate logistic regression analysis) at Days 8, 29, 57 and 85 of Cycle 1 is presented.|Days 8, 29, 57 and 85 (Cycle 1).|The mITT population which consisted of all subjects who were randomised, received study treatment (BTX-A-HAC solution or placebo) and completed one post-treatment assessment of the ILA of glabellar lines at maximum frown. Only subjects with data available at the timepoints of testing are presented.|||Adjusted Percentage of Responders||95% Confidence Interval|Number
2573547|NCT02493946|Secondary|The Percentage of Responders at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Rest: DB Period|The appearance of glabellar lines at rest was assessed in the DB period at post treatment follow-up visits using the ILA, a validated 4-point photographic scale of glabellar line severity. A responder was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at baseline (Day 1 Cycle 1). The adjusted percentage of responders (determined by multivariate logistic regression analysis) at Days 8, 29, 57 and 85 of Cycle 1 is presented.|Days 8, 29, 57 and 85 (Cycle 1).|The mITT population which consisted of all subjects who were randomised, received study treatment (BTX-A-HAC solution or placebo) and completed one post-treatment assessment of the ILA of glabellar lines at maximum frown. Only subjects with data available at the timepoints of testing are presented.|||Adjusted Percentage of Responders||95% Confidence Interval|Number
2573548|NCT02493946|Secondary|The Percentage of Responders on Day 29 Cycle 1 Who Remained Responders on Days 57 and 85 as Measured by the ILA at Maximum Frown: DB Period|The appearance of glabellar lines at maximum frown was assessed in the DB period at post treatment follow-up visits using the ILA, a validated 4-point photographic scale of glabellar line severity. A responder was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at baseline (Day 1 Cycle 1). The percentage of responders (unadjusted) at Day 29 of Cycle 1 who still fulfilled the criteria for a responder at Days 57 and 85 is presented.|Days 29, 57 and 85 (Cycle 1).|The mITT population which consisted of all subjects who were randomised, received study treatment (BTX-A-HAC solution or placebo) and completed one post-treatment assessment of the ILA of glabellar lines at maximum frown. Only responders on Day 29 (n=107,1) and those with data available at the timepoints of testing were included in the analysis.|||Percentage of Responders||95% Confidence Interval|Number
2573549|NCT02493946|Secondary|The Percentage of Responders at Each Post-treatment Visit (Except Day 29 Cycle 1) as Measured by the ILA at Maximum Frown: DB Period|The appearance of glabellar lines at maximum frown was assessed in the DB period at post treatment follow-up visits using the ILA, a validated 4-point photographic scale of glabellar line severity. A responder was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at baseline (Day 1 Cycle 1). The adjusted percentage of responders (determined by multivariate logistic regression analysis) at Days 8, 57 and 85 of Cycle 1 is presented.|Days 8, 57 and 85 (Cycle 1).|The mITT population which consisted of all subjects who were randomised, received study treatment (BTX-A-HAC solution or placebo) and completed one post-treatment assessment of the ILA of glabellar lines at maximum frown. Only subjects with data available at the timepoints of testing are presented.|||Adjusted Percentage of Responders||95% Confidence Interval|Number
2573551|NCT02493868|Secondary|Change From Baseline in Sheehan Disability Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)|The SDS is a participant-reported outcome measure and is a 5-item questionnaire used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1: work/school 2: social life 3: family life/home responsibilities using a 0-10 rating scale. It also has one item on days lost from school or work and one item on days when underproductive. The score for the first 3 items are summed to create a total score of 0-30 where a higher score indicates greater impairment. The recall period is 7 days. Scores <= 4 for each item and <= 12 for the total score are considered response. Scores <= 2 for each item and <= 6 for the total score are considered remission. The change from baseline in SDS total Score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint.|Baseline and Endpoint (Up to 92 Weeks)|Full (stable responders) analysis set: all randomized participants who were stable responders (not stable remitters) at end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM.|||Units on a scale||Standard Deviation|Mean
2573552|NCT02493868|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)|The SDS is a participant-reported outcome measure and is a 5-item questionnaire used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1: work/school 2: social life 3: family life/home responsibilities using a 0-10 rating scale. It also has one item on days lost from school or work and one item on days when underproductive. The score for the first 3 items are summed to create a total score of 0-30 where a higher score indicates greater impairment. The recall period is 7 days. Scores <= 4 for each item and <= 12 for the total score are considered response. Scores <= 2 for each item and <= 6 for the total score are considered remission. The change from baseline in SDS total Score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint.|Baseline and Endpoint (Up to 92 Weeks)|Full (stable remitters) analysis set included all randomized participants who were in stable remission at the end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM.|||Units on a scale||Standard Deviation|Mean
2573553|NCT02493868|Secondary|Change From Baseline in EQ-5D-5L Health Status Index at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)|"EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health)."|Baseline and Endpoint (Up to 92 Weeks)|Full (stable responders) analysis set: all randomized participants who were stable responders (not stable remitters) at end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM.|||Units on a scale||Standard Deviation|Mean
2573554|NCT02493868|Secondary|Change From Baseline in EQ-5D-5L EQ Visual Analogue Scale Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)|EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine).|Baseline and Endpoint (Up to 92 Weeks)|Full (stable responders) analysis set: all randomized participants who were stable responders (not stable remitters) at end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM.|||Units on a scale||Standard Deviation|Mean
2573555|NCT02493868|Secondary|Change From Baseline in EuroQol-5 Dimension-5 Level Sum Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)|"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state."|Baseline and Endpoint (Up to 92 Weeks)|Full (stable responders) analysis set: all randomized participants who were stable responders (not stable remitters) at end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM.|||Units on a scale||Standard Deviation|Mean
2573574|NCT02493764|Secondary|Percentage of Participants in the mMITT Population With a FMR at EFU Visit|"The percentage of participants with a FMR at EFU was determined for each arm. Favorable microbiological response at EOT was defined as either eradication (a lower respiratory tract culture taken at EFU showing eradication of baseline pathogen) or presumed eradication (no specimen collected because the participant deemed clinically cured or improved)."|Up to 16 days after end of therapy (up to Day 30)|The mMITT population includes all randomized participants who received ≥1 dose of study treatment, did not have only gram-positive cocci only on baseline Gram stain, have a baseline bacterial pathogen identified as the cause of HABP/VABP against which IMI/REL has been shown to have antibacterial activity, and have EFU data.|||Percentage of participants|||Number
2573556|NCT02493868|Secondary|Change From Baseline in EQ-5D-5L Health Status Index at Endpoint in Participants With Stable Remission (Maintenance Phase)|"EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health)."|Baseline and Endpoint (Up to 92 Weeks)|Full (stable remitters) analysis set included all randomized participants who were in stable remission at the end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM.|||Units on a scale||Standard Deviation|Mean
2573557|NCT02493868|Secondary|Change From Baseline in EQ Visual Analogue Scale Score at Endpoint in Participants With Stable Remission (Maintenance Phase)|EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine).|Baseline and Endpoint (Up to 92 Weeks)|Full (stable remitters) analysis set included all randomized participants who were in stable remission at the end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM.|||Units on a scale||Standard Deviation|Mean
2573558|NCT02493868|Secondary|Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Sum Score at Endpoint in Participants With Stable Remission (Maintenance Phase)|"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from 0 (dead) to 1.00 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state."|Baseline and Endpoint (Up to 92 Weeks)|Full (stable remitters) analysis set included all randomized participants who were in stable remission at the end of optimization phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM.|||Units on a scale||Standard Deviation|Mean
2573559|NCT02493868|Secondary|Change From Baseline in Generalized Anxiety Disorder-7 Items Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)|GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21). Item responses are summed to yield a total score (range of 0 to 21), with higher scores indicating more anxiety. The change from baseline in GAD-7 total score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint.|Baseline and Endpoint (Up to 92 Weeks)|Full (stable responders) analysis set: all randomized participants who were stable responders (not stable remitters) at end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM.|||Units on a scale||Standard Deviation|Mean
2573560|NCT02493868|Secondary|Change From Baseline in Generalized Anxiety Disorder-7 Items (GAD-7) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)|GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21). Item responses are summed to yield a total score (range of 0 to 21), with higher scores indicating more anxiety. The change from baseline in GAD-7 total score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint.|Baseline and Endpoint (Up to 92 Weeks)|Full (stable remitters) analysis set included all randomized participants who were in stable remission at the end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM.|||Units on a scale||Standard Deviation|Mean
2573575|NCT02493764|Secondary|Percentage of Participants in the mMITT Population With a Favorable Microbiological Response (FMR) at End of Treatment (EOT) Visit|"The percentage of participants with a FMR at EOT was determined for each arm. Favorable microbiological response at EOT was defined as either eradication (a lower respiratory tract culture taken at EOT showing eradication of baseline pathogen) or presumed eradication (no specimen collected because the participant deemed clinically cured or improved)."|From Day 7 to Day 14|The mMITT population includes all randomized participants who received ≥1 dose of study treatment, did not have only gram-positive cocci only on baseline Gram stain, have a baseline bacterial pathogen identified as the cause of HABP/VABP against which IMI/REL has been shown to have antibacterial activity, and have EOT data.|||Percentage of participants|||Number
2573677|NCT02492763|Secondary|Change From Baseline in Fasting High Density Lipoprotein (HDL) Cholesterol at Week 12|This change from baseline reflects the Week 12 fasting HDL cholesterol minus the Week 0 fasting HDL cholesterol.|Baseline and Week 12|All randomized, treated participants with at least one fasting HDL cholesterol measurement (baseline or post-baseline).|||mg/dL||Standard Deviation|Mean
2573561|NCT02493868|Secondary|Change From Baseline in Clinical Global Impression-Severity Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)|CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The change from baseline in CGI-S score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint.|Baseline and Endpoint (Up to 92 Weeks)|Full (stable responders) analysis set: all randomized participants who were stable responders (not stable remitters) at end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM.|||Units on a scale||Full Range|Median
2573562|NCT02493868|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint in Participants With Stable Remission (Maintenance Phase)|CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The change from baseline in CGI-S score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint.|Baseline and Endpoint (Up to 92 Weeks)|Full (stable remitters) analysis set included all randomized participants who were in stable remission at the end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM.|||Units on a scale||Full Range|Median
2573563|NCT02493868|Secondary|Change From Baseline in PHQ-9 Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)|PHQ-9 is a 9-item, self-report scale assessing depressive symptoms. Each item is rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). The change from baseline in PHQ-9 total score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint.|Baseline and Endpoint (Up to 92 Weeks)|Full (stable responders) analysis set: all randomized participants who were stable responders (not stable remitters) at end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM.|||Units on a scale||Standard Deviation|Mean
2573564|NCT02493868|Secondary|Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)|PHQ-9 is a 9-item, self-report scale assessing depressive symptoms. Each item is rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). The change from baseline in PHQ-9 total score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint.|Baseline and Endpoint (Up to 92 Weeks)|Full (stable remitters) analysis set included all randomized participants who were in stable remission at the end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this OM.|||Units on a scale||Standard Deviation|Mean
2573565|NCT02493868|Secondary|Change From Baseline in MADRS Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)|MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal - severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. The change from baseline in MADRS total score (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint.|Baseline and Endpoint (Up to 92 Weeks)|Full (stable responders) analysis set included all randomized participants who were stable responders (who were not stable remitters) at the end of the optimization phase and who received at least 1 dose of intranasal study drug and 1 dose of oral antidepressant during the maintenance phase.|||Units on a scale||Standard Deviation|Mean
2573566|NCT02493868|Secondary|Change From Baseline in MADRS Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)|MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal - severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. The change from baseline in MADRS total score (last observation carried forward [LOCF] data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint.|Baseline and Endpoint (Up to 92 Weeks)|Full (stable remitters) analysis set included all randomized participants who were in stable remission at end of OP phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during MA phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure (OM).|||Units on a scale||Standard Deviation|Mean
2573678|NCT02492763|Secondary|Change From Baseline in Fasting Low Density Lipoprotein (LDL) Cholesterol at Week 12|This change from baseline reflects the Week 12 fasting LDL cholesterol minus the Week 0 fasting LDL cholesterol.|Baseline and Week 12|All randomized, treated participants with at least one fasting LDL cholesterol measurement (baseline or post-baseline).|||mg/dL||Standard Deviation|Mean
2573567|NCT02493868|Secondary|Time to Relapse in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)|Relapse is defined as any of following: MADRS total score >= 22 for 2 consecutive assessments separated by 5-15 days and/or hospitalization for worsening depression or any other clinically relevant event to be suggestive of a relapse of depressive illness such as suicide attempt/completed suicide/hospitalization for suicide prevention; If hospitalized, start date of hospitalization will be date of relapse, if not hospitalized date of event will be used. MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal-severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. Stable response is defined as >= 50 percent (%) reduction in MADRS total score from baseline (Day 1 of induction phase, prior to first intranasal dose) in each of the last 2 weeks of the OP phase, but without meeting criteria for stable remission.|Time from randomization to the first relapse during the maintenance phase (up to 92 Weeks)|Full (stable responders) analysis set included all randomized participants who were stable responders (who were not stable remitters) at the end of the optimization phase and who received at least 1 dose of intranasal study drug and 1 dose of oral antidepressant during the maintenance phase.|||Days||95% Confidence Interval|Median
2573568|NCT02493868|Primary|Time to Relapse in Participants With Stable Remission (Maintenance Phase)|Relapse is defined as any of following: Montgomery-asberg depression rating scale (MADRS) total score greater than or equal to (>=) 22 for 2 consecutive assessments separated by 5-15 days and/or hospitalization for worsening depression or any other clinically relevant event to be suggestive of a relapse of depressive illness such as suicide attempt/completed suicide/hospitalization for suicide prevention; If hospitalized, start date of hospitalization will be date of relapse, if not hospitalized date of event will be used. MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal-severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. Stable remission: MADRS total score less than or equal to (<=) 12 for at least 3 of last 4 weeks of OP phase, with 1 excursion total score greater than (>) 12 or one missing assessment at OP week 13 or 14.|Time from randomization to the first relapse during the maintenance phase (up to 92 Weeks)|Full (stable remitters) analysis set included all the randomized participants who were in stable remission at the end of the optimization phase and received at least 1 dose of intranasal study drug and 1 dose of oral AD during the maintenance phase.|||Days||95% Confidence Interval|Median
2573569|NCT02493855|Primary|Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment|HCV viral kinetics in plasma during therapy were modeled through non-linear mixed effect models, including a rapid first phase of initial decline and a slower second phase decline. The slope of the second phase decline was estimated for each treatment arm.|From Week 0 to Week 2|Participants with evaluable HCV RNA to calculate the slope of the second phase. Three participants were excluded due to algorithm non-convergence in the non-linear modeling process.|||1/day||Full Range|Median
2573570|NCT02493777|Secondary|Parent Rating of Evening and Morning Behavior Revised, Morning Subscale (PREMB-R AM).|The PREMB-R is an 11-item rating scale designed to assess at-home functional impairments in children with ADHD during both early morning (AM) and late afternoon/evening (PM) time periods. With demonstrated validity and reliablility (Faraone et al., 2015), the AM subscale total score (sum of items 1 to 3) was designated in this study as a key secondary endpoint. Items are scored from 0 (none) to 3 (a lot), with higher scores signifying greater impairment of function. The PREMB-R rating scale was completed by parents during the 2-days prior to study visits at the beginning and end of the open-label period (Visits 2 and 8, respectively), as well as at the end of the randomized, double-blind period (Visit 9). At each visit, these ratings were used only for review by the clinician (MD, PhD, DO, licensed social worker, or any trained mental health professional approved by the sponsor) as part of a structured interview to enable collection of a clinician-rated PREMB-R AM subscale score.|PREMB-R AM mean subscale score for the 2-days prior to Visit 9.|Intent-to-Treat|||PREMB-R AM subscale total score||Standard Error|Least Squares Mean
2573571|NCT02493777|Primary|Swanson, Kotkin, Agler, M-Flynn and Pelham Combined Score (SKAMP CS) - Model-adjusted Average of All Post-dose Time Points Assessed During a Laboratory Classroom Test Day (Visit 9).|The SKAMP is a validated, 13-item, observer-rated scale designed to assess the level of impairment of classroom-observed behaviors (Wigal and Wigal, 2006). Items 1 through 4 assess subject attention; items 5 through 8 assess deportment; items 9 through 11 assess quality of work; while items 12 and 13 assess subject compliance with teacher/classroom rules. Each individual item is rated on a 7-point scale from 0 (normal, no impairment) to 6 (maximal impairment). When all individual item scores are summed together, they produce a 13-item combined score that ranges from 0 to 78, with higher scores signifying greater impairment. In the present study, the SKAMP rating scale was utilized across 9 sessions occuring at 8:00 am, 9:00 am, 10:00 am, 12:00 pm, 2:00 pm, 4:00 pm, 6:00 pm, 7:00 pm, and 8:00 pm of the laboratory classroom day. Successful training of qualified individuals on the SKAMP scale was required before raters were allowed to perform study assessments.|12-hours from 8:00 am to 8:00 pm|Intent-to-Treat|||SKAMP CS (12-hour average)||Standard Error|Least Squares Mean
2573572|NCT02493764|Secondary|Percentage of Participants in the ME Population With a FMR at EFU Visit|"The percentage of participants with a FMR at EOT was determined for each arm. Favorable microbiological response at EOT was defined as either eradication (a lower respiratory tract culture taken at EOT showing eradication of baseline pathogen) or presumed eradication (no specimen collected because the participant deemed clinically cured or improved)."|Up to 16 days after end of therapy (up to Day 30)|The ME population is all randomized participants with ≥1 dose of study therapy; not only gram-positive cocci on baseline Gram stain; IMI/REL-sensitive baseline pathogen as cause of HABP/VABP; met entry criteria; no protocol deviations; received minimum duration of IV therapy; have microbiological EFU data and LRT culture available.|||Percentage of participants|||Number
2573585|NCT02493764|Secondary|Percentage of Participants in the CE Population With a FCR at OTX2 (Day 6)|"The percentage of participants with a FCR at OTX2 was determined for each arm. Favorable clinical response at OTX2 was defined as improved (majority of pre-therapy signs and symptoms of the index infection have improved or resolved [or returned to pre-infection status])."|Day 6 (OTX2)|The CE population is all randomized participants with ≥1 dose of study therapy; had not only gram-positive cocci on baseline Gram stain; met important entry criteria; had no protocol deviations; received minimum duration of IV therapy; and have Day 6 clinical response data.|||Percentage of participants|||Number
2573576|NCT02493764|Secondary|Percentage of Participants in the MITT Population With a FCR at Day 28|"The percentage of participants with a FCR at Day 28 was determined for each arm. Favorable clinical response at Day 28 was defined as either sustained cure (all pre-therapy signs and symptoms of the index infection have resolved [or returned to pre-infection status] with no evidence of resurgence and no additional antibiotics are required) or cure (all pre-therapy signs and symptoms of the index infection have resolved [or returned to pre-infection status] and no additional antibiotics are required)."|Day 28|The MITT population includes all randomized participants who received ≥1 dose of study treatment, did not have only gram-positive cocci on Gram stain of the baseline specimen, and have Day 28 data.|||Percentage of participants|||Number
2573577|NCT02493764|Secondary|Percentage of Participants in the MITT Population With a FCR at EOT|"The percentage of participants with a FCR at EOT was determined for each arm. Favorable clinical response at EOT was defined as either cure (all pre-therapy signs and symptoms of the index infection have resolved [or returned to pre-infection status] and no additional antibiotics are required) or improved (the majority of pre-therapy signs and symptoms of the index infection have improved or resolved [or returned to pre-infection status] and no additional antibiotics are required)."|From Day 7 to Day 14|The MITT population includes all randomized participants who received ≥1 dose of study treatment, did not have only gram-positive cocci on Gram stain of the baseline specimen, and have EOT data.|||Percentage of participants|||Number
2573578|NCT02493764|Secondary|Percentage of Participants in the MITT Population With a FCR at OTX3 (Day 10)|"The percentage of participants with a FCR at OTX3 was determined for each arm. Favorable clinical response at OTX3 was defined as improved (majority of pre-therapy signs and symptoms of the index infection have improved or resolved [or returned to pre-infection status])."|Day 10 (OTX3)|The MITT population includes all randomized participants who received ≥1 dose of study treatment, did not have only gram-positive cocci on Gram stain of the baseline specimen, and have Day 10 data.|||Percentage of participants|||Number
2573579|NCT02493764|Secondary|Percentage of Participants in the MITT Population With a FCR at OTX2 (Day 6)|"The percentage of participants with a FCR at OTX2 was determined for each arm. Favorable clinical response at OTX2 was defined as improved (majority of pre-therapy signs and symptoms of the index infection have improved or resolved [or returned to pre-infection status])."|Day 6 (OTX2)|The MITT population includes all randomized participants who received ≥1 dose of study treatment, did not have only gram-positive cocci on Gram stain of the baseline specimen, and have Day 6 data.|||Percentage of participants|||Number
2573580|NCT02493764|Secondary|Percentage of Participants in the MITT Population With a FCR at OTX1 (Day 3)|"The percentage of participants with a FCR at OTX1 was determined for each arm. Favorable clinical response at OTX1 was defined as improved (majority of pre-therapy signs and symptoms of the index infection have improved or resolved [or returned to pre-infection status])."|Day 3 (OTX1)|The MITT population includes all randomized participants who received ≥1 dose of study treatment, did not have only gram-positive cocci on Gram stain of the baseline specimen, and have Day 3 data.|||Percentage of participants|||Number
2573581|NCT02493764|Secondary|Percentage of Participants in the CE Population With a FCR at EFU Visit|"The percentage of participants with a FCR at EFU was determined for each arm. Favorable clinical response at EFU was defined as either sustained cure (all pre-therapy signs and symptoms of the index infection have resolved [or returned to pre-infection status] with no evidence of resurgence and no additional antibiotics are required) or cure (all pre-therapy signs and symptoms of the index infection have resolved [or returned to pre-infection status] and no additional antibiotics are required)."|Up to 16 days after end of therapy (up to Day 30)|The CE population is all randomized participants with ≥1 dose of study therapy; had not only gram-positive cocci on baseline Gram stain; met important entry criteria; had no protocol deviations; received minimum duration of IV therapy; and have EFU clinical response data.|||Percentage of participants|||Number
2573582|NCT02493764|Secondary|Percentage of Participants in the CE Population With a FCR at Day 28|"The percentage of participants with a FCR at Day 28 was determined for each arm. Favorable clinical response at Day 28 was defined as either sustained cure (all pre-therapy signs and symptoms of the index infection have resolved [or returned to pre-infection status] with no evidence of resurgence and no additional antibiotics are required) or cure (all pre-therapy signs and symptoms of the index infection have resolved [or returned to pre-infection status] and no additional antibiotics are required)."|Day 28|The CE population is all randomized participants with ≥1 dose of study therapy; had not only gram-positive cocci on baseline Gram stain; met important entry criteria; had no protocol deviations; received minimum duration of IV therapy; and have Day 28 clinical response data.|||Percentage of participants|||Number
2573583|NCT02493764|Secondary|Percentage of Participants in the CE Population With a FCR at EOT Visit|"The percentage of participants with a FCR at EOT was determined for each arm. Favorable clinical response at EOT was defined as either cure (all pre-therapy signs and symptoms of the index infection have resolved [or returned to pre-infection status] and no additional antibiotics are required) or improved (the majority of pre-therapy signs and symptoms of the index infection have improved or resolved [or returned to pre-infection status] and no additional antibiotics are required)."|From Day 7 to Day 14|The CE population is all randomized participants with ≥1 dose of study therapy; had not only gram-positive cocci on baseline Gram stain; met important entry criteria; had no protocol deviations; received minimum duration of IV therapy; and have EOT clinical response data.|||Percentage of participants|||Number
2573584|NCT02493764|Secondary|Percentage of Participants in the CE Population With a FCR at OTX3 (Day 10)|"The percentage of participants with a FCR at OTX3 was determined for each arm. Favorable clinical response at OTX3 was defined as improved (majority of pre-therapy signs and symptoms of the index infection have improved or resolved [or returned to pre-infection status])."|Day 10 (OTX3)|The CE population is all randomized participants with ≥1 dose of study therapy; had not only gram-positive cocci on baseline Gram stain; met important entry criteria; had no protocol deviations; received minimum duration of IV therapy; and have Day 10 clinical response data.|||Percentage of participants|||Number
2573623|NCT02493361|Secondary|Number of Participants With Adverse Events Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0|Analyses will be performed for all patients having received at least one dose of study drug. The study will use the CTCAE v4.0 for reporting of adverse events.|From enrollment through 30 days after end of treatment, an average of 2 years|||||||
2573586|NCT02493764|Secondary|Percentage of Participants in the Clinically Evaluable (CE) Population With a FCR at On-therapy Visit 1 (OTX1) [Day 3]|"The percentage of participants with a FCR at OTX1 was determined for each arm. Favorable clinical response at OTX1 was defined as improved (majority of pre-therapy signs and symptoms of the index infection have improved or resolved [or returned to pre-infection status])."|Day 3 (OTX1)|The CE population is all randomized participants with ≥1 dose of study therapy; had not only gram-positive cocci on baseline Gram stain; met important entry criteria; had no protocol deviations; received minimum duration of IV therapy; and have Day 3 clinical response data.|||Percentage of participants|||Number
2573587|NCT02493764|Secondary|Percentage of Participants With ACM at EFU in the mMITT Population|The percentage of participants in the mMITT population with mortality due to any cause from randomization through EFU was determined for each arm.|Up to 16 days after end of therapy (up to 30 days)|The mMITT population includes all randomized participants who received ≥1 dose of study treatment and did not have only gram-positive cocci only on baseline Gram stain and who have a baseline bacterial pathogen identified as the cause of HABP/VABP against which IMI/REL has been shown to have antibacterial activity.|||Percentage of participants|||Number
2573588|NCT02493764|Secondary|Percentage of Participants With ACM at EFU in the MITT Population|The percentage of participants in the MITT population with mortality due to any cause from randomization through EFU was determined for each arm.|Up to 16 days after end of therapy (up to 30 days)|The MITT population includes all randomized participants who received ≥1 dose of study treatment and did not have only gram-positive cocci on Gram stain of the baseline specimen.|||Percentage of participants|||Number
2573589|NCT02493764|Secondary|Percentage of Participants With ACM in the Microbiological Modified Intention-to-treat (mMITT) Population|The percentage of participants in the mMITT population with mortality due to any cause from randomization through Day 28 was determined for each arm.|Up to 28 days|The mMITT population includes all randomized participants who received ≥1 dose of study treatment and did not have only gram-positive cocci only on baseline Gram stain and who have a baseline bacterial pathogen identified as the cause of HABP/VABP against which IMI/REL has been shown to have antibacterial activity.|||Percentage of participants|||Number
2573590|NCT02493764|Secondary|Percentage of Participants Discontinuing Study Therapy Due to an AE|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 days|All participants who received ≥1 dose of study therapy are included.|||Percentage of participants|||Number
2573591|NCT02493764|Secondary|Percentage of Participants With ≥1 Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 30 days|All participants who received ≥1 dose of study therapy are included.|||Percentage of participants|||Number
2573592|NCT02493764|Secondary|Percentage of Participants in the MITT Population With a Favorable Clinical Response (FCR) at Early Follow-up (EFU) Visit|"The percentage of participants with a FCR at EFU was determined for each arm. Favorable clinical response at EFU was defined as either sustained cure (all pre-therapy signs and symptoms of the index infection have resolved [or returned to pre-infection status] with no evidence of resurgence and no additional antibiotics are required) or cure (all pre-therapy signs and symptoms of the index infection have resolved [or returned to pre-infection status] and no additional antibiotics are required)."|Up to 16 days after end of therapy (up to 30 days)|The MITT population includes all randomized participants who received ≥1 dose of study treatment and did not have only gram-positive cocci on Gram stain of the baseline LRT specimen.|||Percentage of participants|||Number
2573593|NCT02493764|Primary|Percentage of Participants With All-cause Mortality (ACM) Through Day 28 in the Modified Intention-to-treat (MITT) Population|The percentage of participants in the MITT population with mortality due to any cause from randomization through Day 28 was determined for each arm.|Up to 28 days|The MITT population includes all randomized participants who received ≥1 dose of study treatment and did not have only gram-positive cocci on Gram stain of the baseline lower respiratory tract (LRT) specimen.|||Percentage of participants|||Number
2573594|NCT02493751|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT: greater than or equal to (>=) Grade 3 hematologic/non-hematologic toxicity, Grade 3-4 liver-related laboratory test elevation (alanine aminotransferase, aspartate aminotransferase) with Grade 2 elevation of total bilirubin, non-hematologic Grade 3 laboratory abnormality (required medical intervention to treat participant/led to hospitalization), inability to complete >=75% of first 2 cycles doses of axitinib (from Cycle 1 Day 1 after completion of lead-in period) or 2 infusions of avelumab within DLT observation period due to investigational product related toxicity.|DLT observation period (from the beginning of Cycle 1 up to the end of Cycle 2 [28 days])|DLT evaluable analysis set: First 6 enrolled participants who received at least 1 dose of avelumab and axitinib, and either experienced DLT during DLT observation period or completed it. Data for this endpoint was not planned to be collected and analyzed for “axitinib+ avelumab” arm.|||Participants|||Count of Participants
2573595|NCT02493621|Secondary|Time of First Ambulation|Time of first ambulation relative to anesthesia end time (hours)|48 hours||||Hours||Standard Error|Mean
2573596|NCT02493621|Primary|Opiate Consumption|Cumulative opiate consumption in intravenous (IV) morphine mg equivalents (MME)|48 hours postoperative||||Opiate Consumption (IV MME)||Standard Error|Mean
2573597|NCT02493608|Secondary|Blood Loss|Blood lost during incision/surgery|Blood lost during incision/surgery||||grams||Standard Deviation|Mean
2573598|NCT02493608|Secondary|Post Operative Pain|Done by VAS scale. Visual Analog Scale to measure pain. Scale range from 0 to 10 with higher values indicating worse pain.|Post Operative Day (POD) 1 and Day 2||||units on a scale||Standard Deviation|Mean
2573599|NCT02493608|Primary|Incision Time .|Time to make an abdominal wall incision from skin to rectus fascia.|during surgery||||Seconds||Standard Deviation|Mean
2573626|NCT02493127|Primary|Difference in Grip Strength Measured With Dynamometer|Difference in Grip strength of the injured hand after completing intervention. Each participant completed the grip strength measurement 3 times on the injured hand at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.|Day 1||||pounds||Standard Deviation|Mean
2573600|NCT02493517|Secondary|Percentage of Subjects With at Least One Symptom of Acromegaly at Week 13 and at the EOST/EW Visit Compared to Baseline|The percentage of subjects with at least one symptom of acromegaly at Week 13 and at the EOST/EW Visit compared with baseline is presented for subjects treated with lanreotide Autogel and lanreotide PR. The symptoms of acromegaly monitored included: headache, excessive perspiration, fatigue, soft tissue swelling and arthralgia.|Baseline, Week 13 Visit and EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).|The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised.|||Percentage of Subjects|||Number
2573601|NCT02493517|Secondary|Median Percentage Change From Baseline in Tumour Volume at the EOST/EW Visit|"The median percentage change in the solid component of the tumour volume from baseline to the EOST/EW Visit is presented.~The tumour volume was measured by MRI at Screening and at the EOST/EW Visit, and then assessed by two independent blinded readers."|Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).|The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. Data is presented for the subgroup of subjects in the ITT population who had solid tumours at baseline.|||Percentage change in tumour volume||Full Range|Median
2573602|NCT02493517|Secondary|Percentage of Subjects With at Least 20% Reduction in Tumour Volume at EOST/EW Visit Compared to Baseline|"The percentage of subjects with at least a 20% reduction in the solid component of the tumour volume at the EOST/EW Visit compared to baseline is presented for the subgroup of subjects who had solid tumours at baseline.~The tumour volume was measured by Magnetic Resonance Imaging (MRI) at Screening and at the EOST/EW Visit, and then assessed by two independent blinded readers."|Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).|The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. Data is presented for the subgroup of subjects in the ITT population who had solid tumours at baseline.|||Percentage of Subjects|||Number
2573603|NCT02493517|Secondary|Mean Change From Baseline in GH Values at the EOST/EW Visit|The mean change from baseline in GH values at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR.|Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).|The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised. Subjects with data available at time of analysis are presented.|||mcg/L||Standard Deviation|Mean
2573604|NCT02493517|Secondary|Percentage of Subjects With Normal Age-adjusted IGF-1 Levels and Who Have GH Levels >1 mcg/L and ≤2.5 mcg/L at the EOST/EW Visit|"The percentage of subjects with normal age-adjusted IGF-1 levels and who have GH levels >1 mcg/L but ≤2.5 mcg/L at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR. The calculation of percentages was based on the overall ITT population.~At baseline, all subjects had abnormal IGF-1 levels and GH levels >2.5 mcg/L as per protocol entry criteria."|Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).|The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised.|||Percentage of Subjects|||Number
2573605|NCT02493517|Secondary|The Percentage of Subjects With GH ≤1 mcg/L at the EOST/EW Visit|"The percentage of subjects with GH ≤1 mcg/L at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR.~At baseline, all subjects had GH levels >2.5 mcg/L as per protocol entry criteria."|Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).|The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised.|||Percentage of Subjects|||Number
2573606|NCT02493517|Secondary|Percentage of Subjects With GH ≤2.5 Micrograms Per Litre (mcg/L) at the EOST/EW Visit|"The percentage of subjects with GH ≤2.5 mcg/L at the EOST/EW Visit is presented for subjects treated with lanreotide Autogel and lanreotide PR.~At baseline, all subjects had GH levels >2.5 mcg/L as per protocol entry criteria."|Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).|The ITT population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised.|||Percentage of Subjects|||Number
2573607|NCT02493517|Secondary|Percentage of Subjects With Normal Age-adjusted IGF-1 Levels at the EOST/EW Visit|"The percentage of subjects with normal age-adjusted IGF-1 levels at the EOST/EW Visit is presented for subjects treated with Lanreotide Autogel and Lanreotide PR.~At baseline, all subjects had abnormal IGF-1 levels as per protocol entry criteria."|Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).|The Intention-To-Treat (ITT) population consisted of all randomised and treated subjects who had at least one baseline and at least one postbaseline assessment of the primary efficacy parameter. The ITT population was analysed using subjects as randomised.|||Percentage of Subjects|||Number
2573624|NCT02493361|Primary|Best Overall Objective Response Rate (ORR) Within 24 Weeks Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|"Best overall ORR within 24 weeks of first treatment with pIL-12 EP and pembrolizumab will be determined using RECIST v1.1 by investigator evaluation~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions determined by 2 separate scans conducted not < 4 weeks apart and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (the sum may not be 0 if there are target nodes) and no appearance of new lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no appearance of new lesions. ORR = CR + PR."|Up to week 24||||Percentage of Participants|||Number
2573608|NCT02493517|Primary|Standardised Mean Change From Baseline in Age-adjusted IGF-1 Levels at the EOST/EW Visit|"The standardised mean change from Baseline in age-adjusted log-transformed IGF-1 standard deviation score (SDS) at EOST/EW is presented for subjects treated with both lanreotide Autogel and lanreotide PR. Back-transformed results are presented in addition to the results without back-transformation.~For each subject the IGF-1 SDS value was calculated based on the z-score derivation: IGF-1 SDS = (IGF-1 - mean)/ standard deviation (SD), with mean and SD derived from the upper limit of normal (ULN) and lower limit of normal (LLN) margins for each age category. ULN = Mean + 2 SD; LLN = Mean - 2 SD.~The SDS indicates the number of standard deviations away from the mean. A SDS of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A negative change in the SDS indicates a decrease in the mean age-adjusted IGF-1 values."|Baseline to EOST/EW Visit (up to Week 33 for the lanreotide Autogel group and up to Week 32 for the lanreotide PR group).|The Per Protocol population consisted of all subjects who were randomised and treated with at least one baseline and at least one postbaseline assessment of the primary efficacy parameter and for whom no major protocol deviations occurred with impact on efficacy assessment.|||SDS||Standard Error|Least Squares Mean
2573609|NCT02493452|Secondary|Change From Baseline in Abdominal Pain|Change from baseline in abdominal pain as measured with an 11-point (0-10) Numerical Rating Scale from 0 (None) to 10 (Worst Possible). Baseline was the mean of the non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The average daily abdominal pain score was the average of the non-missing worst daily abdominal pain scores (on a 0 to 10 scale) in the given week.|Baseline and 12-Week||||score on a scale||Standard Deviation|Mean
2573610|NCT02493452|Secondary|Number of Patients With a SBM Within 24 Hours After First Dose of Study Medication|A responder was any patient with a SBM within 24 hours after the first dose of study drug.|Up to 24 hours after the first dose of study drug||||Participants|||Count of Participants
2573611|NCT02493452|Secondary|Change From Baseline in CSBMs (CSBMs/Week)Complete Spontaneous Bowel Movement|Change from baseline over the 12-week Treatment Period in CSBM (Complete Spontaneous Bowel Movement) Frequency Rate (CSBMs/Week). Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.|Baseline and 12-Week||||CSBMs per week||Standard Deviation|Mean
2573612|NCT02493452|Secondary|Change From Baseline in Straining|Change from baseline in Straining Score over the 12-week treatment period. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The severity of straining during a bowel movement was measured using an 11-point scale (0-10 rating; 0 = no straining; 10 = worst straining).|Baseline and 12-Week||||score on a scale||Standard Deviation|Mean
2573613|NCT02493452|Secondary|Change From Baseline in Stool Consistency|"Change from baseline in stool consistency based upon the Bristol Stool Form Scale (BSFS). Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS Rating 1 to 7:~Separate hard lumps, like nuts (hard to pass)~Sausage-shaped but lumpy~Like a sausage but with cracks on its surface~Like a sausage or snake, smooth and soft~Soft blobs with clear-cut edges (passed easily)~Fluffy pieces with ragged edges, a mushy stool~Watery, no solid pieces, entirely liquid"|Baseline and 12-Week||||score on a scale||Standard Deviation|Mean
2573614|NCT02493452|Secondary|Number of Sustained Efficacy Responders|A Sustained Efficacy Responder was a patient who was an Overall Responder who also was a Weekly Responder, i.e., decreased of 30% from baseline for abdominal pain intensity and increased of at least one CSBM (complete spontaneous bowel movement) in the same week for at least 2 of the 4 weeks in month 3 of the Treatment Period.|12 Weeks||||Participants|||Count of Participants
2573615|NCT02493452|Primary|Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks|A Stool Frequency Responder was a patient who experienced an increase of at least one CSBM (complete spontaneous bowel movement) per week from baseline. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.|12 Weeks||||Participants|||Count of Participants
2573616|NCT02493452|Primary|Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks|An Abdominal Pain Intensity Responder was a patient who had a decrease of 30 % from baseline for abdominal pain intensity. Baseline is the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.|12 Weeks||||Participants|||Count of Participants
2573617|NCT02493452|Primary|Number of Overall Responders - ITT Population|An Overall Responder was a patient who was a weekly responder (i.e., decrease of 30% from baseline for abdominal pain intensity and an increase of at least 1 complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks.|12 weeks||||Participants|||Count of Participants
2573618|NCT02493361|Secondary|Best Overall ORR Determined by Immune Related- Response Criteria (irRC)|Best overall objective response rate, CR + PR, as determined by irRC.|From treatment initiation until disease progression, start of new treatment, or end of study, whichever occurs first, about 5 years|||||||
2573619|NCT02493361|Secondary|Overall Survival (OS)|OS is defined as the duration between the date of treatment initiation to the date of death, regardless of the cause of death.|From treatment initiation until death or end of the study, whichever occurs first, about 5 years|||||||
2573620|NCT02493361|Secondary|Median PFS Assessed by RECIST v1.1|PFS is defined as the duration between the date of treatment initiation to the first date of either disease progression or death. Tumor response determinations were assessed by RECIST v1.1.|From treatment initiation until disease progression, start of new treatment, or end of study, whichever occurs first, about 5 years|||||||
2573621|NCT02493361|Secondary|Twenty-Four Week Landmark Progression Free Survival (PFS) Assessed by RECIST v1.1|Twenty-four week landmark PFS (PFS at 24) is defined as the percentage of patients, who have progressed at the 24 week time point. Tumor response determinations were assessed by RECIST v1.1.|At 24 weeks after treatment initiation|||||||
2573622|NCT02493361|Secondary|Duration of Response (DOR) Assessed by RECIST v1.1|DOR for those experiencing CR or PR is the number of days from the initial documentation of an objective response to the most current evaluation of that response (censored duration) or to documentation of progression. Response determinations are assessed by RECIST v1.1.|From treatment initiation until disease progression, start of new treatment, or end of study, whichever occurs first, about 5 years|||||||
2573627|NCT02493127|Primary|Difference in Grip Strength Measured With Dynamometer|Difference in Grip strength of the non-affected hand after completing intervention. Each participant completed the grip strength measurement 3 times on the non-affected hand at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.|Day 1||||pounds||Standard Deviation|Mean
2573628|NCT02493127|Primary|Positive Pain Catastrophizing Scale (PCS)|The positive pain catastrophizing scale (PCS) is a positively-phrased 13-item scale to measure catastrophic thinking. The scale is from 0-4 and scores range from 0-52, a higher score indicates less catastrophic thinking about pain.|enrollment||||units on a scale||Standard Deviation|Mean
2573629|NCT02493127|Primary|Pain Catastrophizing Scale (PCS)|The pain catastrophizing scale is a 13-item scale to measure catastrophic thinking. The scale is from 0-4 and scores range from 0-52, a lower score indicates less catastrophic thinking about pain.|enrollment||||units on a scale||Standard Deviation|Mean
2573630|NCT02493088|Secondary|Number of Observed Situations Per Type of Aberrant Driving Behavior (Auto-aggressive, Aggressive or Other Hetero Transgression)|"Auto-aggressive: attempted suicide, any gesture of mutilation (scarification, punching in a wall, etc.) Aggressive: rixes with fellow inmates or prison staff, attempted homicides, sexual assaults, etc.~Other hetero transgression: Failure to comply with the rules of the institution, illegal entry of illicit objects into the establishment, consumption of toxic materials, destruction of property, etc."|6 months||||number of observed situations|||Number
2573631|NCT02493088|Secondary|Percentage of Aberrant Driving Behaviors With Contextual Element Observed Before Aberrant Driving Behaviors|"Collected contextual elements were :~Disorders in the institution (with a caregiver, frustration with the rules)~Difficulty / frustration with an inmate~Difficulty / frustration with the entourage~Consumption of alcohol or other toxic substances~Steps in the judicial process (refusal of parole, reduction of sentence ...)~Psychiatric symptoms: delirious, sleep disorders, nightmares The numerator for the percentage calculated is the number of aberrant driving behaviors with contextual element.~The denominator for the percentage calculated is the total number of aberrant driving behaviors (with and without contextual element)"|6 months||||percent of aberrant driving behaviors|Number of aberrant driving behaviors|95% Confidence Interval|Number
2573632|NCT02493088|Primary|The Number of Individuals Diagnosed With Antisocial Personality Disorder in Rochefort Prison With Aberrant Driving Behaviors.||6 months||||participants|||Number
2573633|NCT02493062|Primary|Percent of Participants With/Without Dehiscence (>80% Thinning of the Myometrium) at the Niche|Yes >80% of thinning of the myometrium at the niche or No < 80% of thinning of the myometrium at the niche of the hysterotomy measured by the sonohysterogram.|Minimum of 6 months after delivery.||||percentage of patients with >80% thinnin|||Number
2573634|NCT02493062|Primary|Fetal Myelomeningocele Hysterotomy Site Myometrial Percentage of Thinning at the Niche|"Average myometrium will be calculated, measured by the sonohysterogram. The myometrium will be measure to the right and left of the niche and averaged ((Right side in mm + Left side in mm)/2)=Average myometrium thickness The myometrium at niche will be measured (niche mm). Average myometrium-niche mm= niche thinning (mm).~Niche thinning / Average myometrium thickness= Percentage of thinning at the niche.~Ex:~Average thickness at niche: 0.5 mm Right sided myometrium thickness: 1.5 mm Left sided myometrium thickness: 1.5 mm~1.5mm + 1.5mm= 3mm/ 2= 1.5mm (average Myometrium Thickness)~1.5mm- 0.5mm = 1.0 mm (Niche thinning)~0.5mm / 1.0 mm (% of thinning at the niche)"|Minimum of 6 months after delivery.||||percentage of thinning at the niche||Full Range|Mean
2573635|NCT02493062|Primary|Fetal Myelomeningocele Hysterotomy Site Myometrial Thickness|Average myometrium thickness surrounding niche is measured by measuring average thickness of the myometrium to the right and left of the niche resulting in the average myometrium thickness surrounding the niche. This is measured by the sonohysterogram.|Minimum of 6 months after delivery.||||millimeter||Full Range|Median
2573636|NCT02493062|Primary|Cesarean Hysterotomy Site Myometrial Percentage of Thinning at the Niche|"Average myometrium will be calculated, measured by the sonohysterogram. The myometrium will be measured caudad and cephalad of the niche and averaged ((Caudad side in mm + Cephalad side in mm)/2)=Average myometrium thickness The myometrium at niche will be measured (niche mm). Average myometrium-niche mm= niche thinning (mm).~Niche thinning / Average myometrium thickness= Percentage of thinning at the niche.~Ex:~Average thickness at niche: 0.5 mm Caudad myometrium thickness: 1.5 mm Cephalad myometrium thickness: 1.5 mm~1.5mm + 1.5mm= 3mm/ 2= 1.5mm (average Myometrium Thickness)~1.5mm- 0.5mm = 1.0 mm (Niche thinning)~0.5mm / 1.0 mm (% of thinning at the niche)"|Minimum of 6 months after delivery.||||percentage of thinning||Full Range|Mean
2573637|NCT02493062|Primary|Cesarean Hysterotomy Myometrial Thickness|Average myometrium thickness surrounding niche is measured by measuring Average thickness of the myometrium toward the cervix and toward the fundus resulting in the average myometrium thickness surrounding the niche, measured by the sonohysterogram.|Minimum of 6 months after delivery.||||millimeter||Full Range|Mean
2573638|NCT02493036|Primary|Change From Study 1 (NCT02495623) Baseline in the Area Under the Curve (AUC) of Breath CH4 Production, Based on a 180-minute Lactulose Breath Test (LBT) at Day 56 Post-dose.||56 days|In this table, there are 16, 18 and 14 subjects in the 42mg/42mg, 21mg/42mg and Placebo/42mg group, respectively. This is a change-from-baseline analysis, only subjects with no missing values AT BOTH baseline and Day 56 are included in the analysis, so the number of subjects in each group is less than the number of subjects that started the study.|||ppm*hr||Standard Deviation|Mean
2573639|NCT02492984|Secondary|Number of Confirmed LETE in the Low Recovery Setting|LETE could also be lower than expected recovery of FVIII in the opinion of the investigator following infusion of Xyntha in the absence of confounding factors. The only confounding factors for low recovery were: known presence or subsequent identification of a FVIII inhibitor; known compromised Xyntha; faulty administration of Xyntha, including inadequate dosing.|From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.|The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.|||LETE bleeds|||Number
2573679|NCT02492763|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|This change from baseline reflects the Week 12 FPG minus the Week 0 FPG.|Baseline and Week 12|All randomized, treated participants with at least one FPG measurement (baseline or post-baseline).|||mg/dL||95% Confidence Interval|Least Squares Mean
2573640|NCT02492984|Secondary|Percentage of Less Than Expected Therapeutic Effect (LETE) in the On-Demand Setting|"LETE occurred in the on-demand setting if 2 successive No Response ratings were recorded after 2 successive Xyntha drug infusions, respectively.The infusions must have been administered within 24 hours (less than or equal to 24 hours) of each other for treatment of the same bleeding event in the absence of confounding factors (prespecified). Therefore, LETE in the on-demand setting was based on the response to treatment of a bleeding episode (including those occurring during the surgical prophylaxis period). Note that on-demand treatments administered during the surgical prophylaxis period were also to be included."|From Day 1 up to participants had received treatment for 6 months or participants had achieved 50 EDs whichever occurred first.|The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.|||percentage of bleeding episodes|bleeding episodes|95% Confidence Interval|Number
2573641|NCT02492984|Secondary|Average Infusion Dose and Total Factor VIII Consumption for On-Demand Treatment and Surgical Prophylaxis Treatment|The total amount (IU) infused for each Xyntha infusion recorded in the study drug infusion log case report form (CRF) was summed to calculate the total factor VIII consumption for each participant. The average infusion dose for each participant was calculated as his total factor VIII consumption (in IU) divided by the number of infusions administered. The total factor VIII consumption, divided by number of infusions, was summarized similarly to average infusion dose (IU).|On-Demand Group: Day 1 up to 6 months or 50 EDs whichever occurred first. Surgical Prophylaxis Group: Day of surgery to postoperative period. The duration of postoperative period is specified in previous endpoints.|All participants who received at least one dose of Xyntha during the study|||International Unit (IU)||Standard Deviation|Mean
2573642|NCT02492984|Secondary|Number of Participants With Transfusion Requirement for Surgical Prophylaxis Treatment|Number of participants with transfusion requirement for surgical prophylaxis treatment. Transfusion requirements during the intraoperative and the postoperative period were assessed by investigator or surgeon. The number of units and types of blood products transfused were recorded if applicable.|From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery)|"Surgical prophylaxis participants during their surgical prophylaxis period. The data for this outcome was not planned to be analyzed for the on-demand group."|||participants|||Number
2573643|NCT02492984|Secondary|Actual Estimated Blood Loss for Surgical Prophylaxis Treatment|Number of participants with blood loss in each category (Abnormal, Normal, and Absence). Blood loss during the intraoperative and the postoperative period were assessed by investigator or surgeon, which were rated as Abnormal, Normal, and Absence. Abnormal blood loss meant the blood loss was higher over the expectation for the non hemophilic participant.|From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery)|"Surgical prophylaxis participants during their surgical prophylaxis period. The data for this outcome was not planned to be analyzed for the on-demand group. Number of participants analyzed signifies participants evaluable for this outcome measure."|||partcipants|||Number
2573644|NCT02492984|Secondary|Hemostatic Efficacy for Surgical Prophylaxis Treatment|Assessment of hemostatic efficacy was determined by the investigator and/or surgeon using the 4 point Surgical Hemostasis Efficacy Rating Scale. Excellent: Achieved hemostasis comparable to that expected after similar surgery in a non hemophilic participant. Good: Prolonged time to hemostasis, with somewhat increased bleeding compared to that expected after similar surgery in a non hemophilic participant. Moderate: Obviously delayed hemostasis, but manageable with additional infusions. No Response: No hemostatic response. The percentage of observations in each hemostatic efficacy response category (excellent, good, moderate, none) was reported.|From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery)|"Surgical prophylaxis participants during their surgical prophylaxis period. The data for this outcome was not planned to be analyzed for the on-demand group."|||percentage of observations|||Number
2573645|NCT02492984|Secondary|Frequency of Xyntha Infusions to Treat Each New Bleed for On-Demand Group|The number of bleeds resolved with 1, 2, 3, 4, or >4 infusions was reported for each of the categories (1, 2, 3, 4, or >4 infusions needed to treat the bleed), in which the numerator was the number of bleeds falling into each category, and the denominator was the total number of new bleeds across all participants.|From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.|"Participants with a bleed during the study for which on-demand treatment with Xyntha was administered. The data for this outcome was not planned to be analyzed for the surgical prophylaxis group."|||percentage of bleeds|bleeds||Number
2573646|NCT02492984|Secondary|Number of Infusions Needed to Treat Each New Bleed for On-Demand Treatment|The number of Xyntha infusions administered to treat a bleed was determined. This was calculated by adding the on-demand initial treatment and any on-demand follow-up infusions for the same bleed (same bleed start date/time).|From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.|"Participants with a bleed during the study for which on-demand treatment with Xyntha was administered. The data for this outcome was not planned to be analyzed for the surgical prophylaxis group."|||infusions||Standard Deviation|Mean
2573655|NCT02492958|Secondary|Antigen-specific Competitive Luminex Immunoassay (cLIA) Geometric Mean Titers (GMTs)|Geometric mean titer is commonly used to assess the immunogenicity of vaccine. Antibody GMTs as measured by cLIA for ClfA and MntC and corresponding 2-sided 95 percent (%) confidence intervals (CIs) were evaluated. CIs were computed by back transforming the CIs generated for means of the titers on the log scale based on the Student t distribution.|Baseline, Day 11, 15, 29 and Month 3|The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for the primary immunogenicity analysis.|||Titer||95% Confidence Interval|Geometric Mean
2573680|NCT02492763|Secondary|Change From Baseline in Body Weight at Week 12|This change from baseline reflects the Week 12 body weight minus the Week 0 body weight.|Baseline and Week 12|All randomized, treated participants with at least one body weight measurement (baseline or post-baseline).|||Kilograms||95% Confidence Interval|Least Squares Mean
2573647|NCT02492984|Secondary|Response Assessment of On-Demand Treatment of Bleeds|The proportion of infusions (initial and subsequent for a bleed) in each response category (excellent, good, moderate, no response) was reported. Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered. Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least 1 additional infusion administered for complete resolution of the bleeding episode or definite pain relief and/or improvement in signs of bleeding starting after 8 hours following the infusion, with no additional infusion administered. Moderate: Probable or slight improvement starting after 8 hours following the infusion, with at least 1 additional infusion administered for complete resolution of the bleeding episode. No Response: No improvement at all between infusions or during the 24 hour interval following an infusion, or condition worsens.|From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first.|"Participants with a bleed during the study for which on-demand treatment with Xyntha was administered. The data for this outcome was not planned to be analyzed for the surgical prophylaxis group."|||percentage of infusions|infusions||Number
2573648|NCT02492984|Secondary|Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs.|From Day 1 up to 28 calendar days after End of Treatment (participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first).|The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.|||participants|||Number
2573649|NCT02492984|Primary|Percentage of Participants With Factor VIII (FVIII) Inhibitors|Percentage of participants with the product medically important event (MIE) (FVIII inhibitor development during the study).|From Day 1 up to 28 calendar days after End of Treatment (participants had received treatment for 6 months or when participants had achieved 50 exposure days [EDs] whichever occurred first).|The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study.|||percentage of participants||95% Confidence Interval|Number
2573650|NCT02492958|Secondary|Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific FBI Titers From Baseline to Day 11, 15, 29 and Month 3|GMFR of anti-Staphylococcus aureus FBI for ClfA was computed. CIs which are reported below were computed by back transforming the CIs generated for the mean fold rise on the log scale based on the Student t distribution. GMFRs were computed as the fold rise in titer value at specified time point compared to baseline.|Baseline, Day 11, 15, 29 and Month 3|The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for the primary immunogenicity analysis.|||Fold rise||95% Confidence Interval|Geometric Mean
2573651|NCT02492958|Secondary|Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific OPA Titers From Baseline to Day 11, 15, 29 and Month 3|GMFRs of anti-Staphylococcus aureus OPA for CP5 and CP8 were computed. CIs which are reported below were computed by back transforming the CIs generated for the mean fold rise on the log scale based on the Student t distribution. GMFRs were computed as the fold rise in titer value at specified time point compared to baseline.|Baseline, Day 11, 15, 29 and Month 3|"The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for primary immunogenicity analysis. Here n signifies number of participants who were evaluable for specific antigens for each arm, respectively."|||Fold rise||95% Confidence Interval|Geometric Mean
2573652|NCT02492958|Secondary|Geometric Mean Fold Rise (GMFR) for Staphylococcus Aureus Antigen-specific cLIA Titers From Baseline to Day 11, 15, 29 and Month 3|GMFRs of anti-Staphylococcus aureus cLIA for ClfA and MntC were computed. CIs which are reported below were computed by back transforming the CIs generated for the mean fold rise on the log scale based on the Student t distribution. GMFRs were computed as the fold rise in titer value at specified time point compared to baseline.|Baseline, Day 11, 15, 29 and Month 3|The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for the primary immunogenicity analysis.|||Fold rise||95% Confidence Interval|Geometric Mean
2573653|NCT02492958|Secondary|Antigen-specific Fibrinogen-binding Inhibition (FBI) Assay Geometric Mean Titers (GMTs)|Geometric mean titer is commonly used to assess the immunogenicity of vaccine. Antibody GMTs as measured by FBI for ClfA and corresponding 2-sided 95 percent CIs were evaluated. CIs were computed by back transforming the CIs generated for means of the titers on the log scale based on the Student t distribution.|Baseline, Day 11, 15, 29 and Month 3|The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for the primary immunogenicity analysis.|||Titer||95% Confidence Interval|Geometric Mean
2573654|NCT02492958|Secondary|Antigen-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs)|Geometric mean titer is commonly used to assess the immunogenicity of vaccine. Antibody GMTs as measured by OPA for CP5 and CP8 and corresponding 2-sided 95 percent CIs were evaluated. CIs were computed by back transforming the CIs generated for means of the titers on the log scale based on the Student t distribution.|Baseline, Day 11, 15, 29 and Month 3|"The evaluable immunogenicity population included all participants who received the investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for primary immunogenicity analysis. Here n signifies number of participants who were evaluable for specific antigens for each arm, respectively."|||Titer||95% Confidence Interval|Geometric Mean
2573675|NCT02492763|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) at Week 12|This change from baseline reflects the Week 12 SBP minus the Week 0 SBP.|Baseline and Week 12|All randomized, treated participants with at least one SBP measurement (baseline or post-baseline).|||mmHg||95% Confidence Interval|Least Squares Mean
2573656|NCT02492958|Secondary|Percentage of Participants Achieving Predefined Antibody Response to Target Antigens on Baseline, Day 11, 15 and Month 3|Percentage of participants achieving predefined antibody response to CP5, CP8, ClfA and MntC at Baseline, Day 11, 15 and Month 3 were reported. The predefined thresholds for the target antigens were 1000 and 2000 based on OPA assay for CP5 and CP8, respectively; was 121 based on FBI assay for ClfA, 512 based on cLIA for MntC.|Baseline, Day 11, 15 and Month3|"The evaluable immunogenicity population included all participants who received investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for primary immunogenicity analysis. Here n signifies the number of participants who were evaluable for specific antigens for each arm, respectively."|||Percentage of participants||95% Confidence Interval|Number
2573657|NCT02492958|Primary|Percentage of Participants Achieving Predefined Antibody Response to Target Antigens at Day 29|Percentage of participants achieving predefined antibody response to capsular polysaccharide serotype 5 (CP5), capsular polysaccharide serotype 8 (CP8), clumping factor A (ClfA) and manganese transporter C (MntC) at Day 29 were reported. The predefined thresholds for the target antigens were 1000 and 2000 based on opsonophagocytic activity (OPA) assay for CP5 and CP8, respectively; was 121 based on fibrinogen-binding inhibition (FBI) assay for ClfA and 512 based on competitive Luminex immunoassay (cLIA) for MntC.|Day 29|"The evaluable immunogenicity population included all participants who received investigational product to which they were randomized, had valid and determinate assay result for at least 1 antigen for primary immunogenicity analysis. Here n signifies the number of participants who were evaluable for specific antigens for each arm, respectively."|||Percentage of participants||95% Confidence Interval|Number
2573658|NCT02492958|Primary|Percentage of Participants With Blood Chemistry Abnormalities at Day 15|Blood chemistry laboratory analysis included the following parameters: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, bilirubin, creatinine, creatine kinase and lactate dehydrogenase, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Blood chemistry abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in blood chemistry laboratory parameters are reported in this outcome measure.|Day 15|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
2573659|NCT02492958|Primary|Percentage of Participants With Blood Chemistry Abnormalities at Day 5|Blood chemistry laboratory analysis included the following parameters: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, bilirubin, creatinine, creatine kinase and lactate dehydrogenase, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Blood chemistry abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in blood chemistry laboratory parameters are reported in this outcome measure.|Day 5|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
2573660|NCT02492958|Primary|Percentage of Participants With Coagulation Abnormalities at Day 15|Coagulation analysis included the following parameters: PT, APTT, platelet AGG with ADP, platelet AGG with arachidonic acid, platelet AGG with collagen and fibrinogen activity. PT and APTT were scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Coagulation abnormality was defined as at least 1 grade abnormal value for PT and APTT, and deviation from local laboratory range for platelet aggregation assay and fibrinogen activity assay. Percentage of participants with abnormal values in coagulation parameters are reported in this outcome measure.|Day 15|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
2573661|NCT02492958|Primary|Percentage of Participants With Coagulation Abnormalities at Day 5|Coagulation analysis included the following parameters: prothrombin time (PT), activated partial thromboplastin time (APTT), platelet aggregation (AGG) (with adenosine diphosphate [ADP], with arachidonic acid, and with collagen) and fibrinogen activity. PT and APTT were scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Coagulation abnormality was defined as at least 1 grade abnormal value for PT and APTT, and deviation from local laboratory range for platelet aggregation assay and fibrinogen activity assay. Percentage of participants with abnormal values in coagulation parameters are reported in this outcome measure.|Day 5|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
2573662|NCT02492958|Primary|Percentage of Participants With Hematology Abnormalities at Day 15|Hematology analysis included the following parameters: hemoglobin, white blood cells, neutrophils and platelets, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Hematology abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in hematology parameters are reported in this outcome measure.|Day 15|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here N signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
2573663|NCT02492958|Primary|Percentage of Participants With Hematology Abnormalities at Day 5|Hematology analysis included the following parameters: hemoglobin, white blood cells, neutrophils and platelets, and scaled as Grade 1= mild; Grade 2= moderate; Grade 3= severe; or Grade 4. Hematology abnormality was defined as at least 1 grade abnormal value. Percentage of participants with abnormal values in hematology parameters are reported in this outcome measure.|Day 5|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination. Here ‘number of participants analyzed (N)’ signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
2573676|NCT02492763|Secondary|Change From Baseline in Fasting Triglycerides at Week 12|This change from baseline reflects the Week 12 fasting triglycerides minus the Week 0 fasting triglycerides.|Baseline and Week 12|All randomized, treated participants with at least one fasting triglycerides measurement (baseline or post-baseline).|||mg/dL||Standard Deviation|Mean
2573664|NCT02492958|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) Reported After Day 29 Visit Through Month 12|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or deemed medically significant for any other reason. A treatment emergent AE was defined as an event that emerged during the study that was absent before administration of investigational product, or worsened relative to the pre-administration state. AEs reported during this time period included both SAEs and newly diagnosed chronic medical disorders (NDCMD). A NDCMD was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.|After Day 29 up to Month 12|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.|||Percentage of participants|||Number
2573665|NCT02492958|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) Reported From Day 1 Up to Day 29 Visit|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious AEs. Treatment-emergent AEs were events between the administration of investigational product and up to Day 29 that were absent before vaccination or that worsened relative to pre-administration state.|Day 1 up to Day 29|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.|||Percentage of participants|||Number
2573666|NCT02492958|Primary|Percentage of Participants With Systemic Events by Severity Within 14 Days of Vaccination|Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 37.5 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity).|Day 1 up to Day 14|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.|||Percentage of participants||95% Confidence Interval|Number
2573667|NCT02492958|Primary|Percentage of Participants With At Least 1 Systemic Event Within 14 Days of Vaccination|Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and recorded by using an e-diary. Fever was graded as 37.5 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and greater than (>) 40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity). In this outcome measure percentage of participants with any systemic event was reported.|Day 1 up to Day 14|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.|||Percentage of participants||95% Confidence Interval|Number
2573668|NCT02492958|Primary|Percentage of Participants With Local Reactions by Severity Within 14 Days of Vaccination|Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (2.5 to 5.0 cm), moderate (5.5 to 10.0 cm) and, severe (>=10.5 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).|Day 1 up to Day 14|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.|||Percentage of participants||95% Confidence Interval|Number
2573669|NCT02492958|Primary|Percentage of Participants With At Least 1 Local Reaction Within 14 Days of Vaccination|Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were defined as mild (2.5 to 5.0 centimeters [cm]), moderate (5.5 to 10.0 cm) and, severe (greater than or equal to [>=] 10.5 cm). Pain at injection site was defined as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). In this outcome measure percentage of participants with any local reaction was reported.|Day 1 up to Day 14|Safety population included all participants who received at least 1 dose of investigational product and had safety data available after vaccination.|||Percentage of participants||95% Confidence Interval|Number
2573670|NCT02492880|Primary|Change in Paresthesia Distribution From Subject Completed Paresthesia Drawing Questionnaire|Change in paresthesia distribution based on programming parameters|minimum 25 days post IPG implant||||Participants|||Count of Participants
2573671|NCT02492841|Secondary|Adverse Effects|Name any adverse effects.|1 week, 3 and 6 months|There were no adverse effects in the population studied.|||Participants|||Count of Participants
2573672|NCT02492841|Primary|Treatment Outcome|vitality test with electric device cold and hot test radiographic evaluation|3 months, 6 moths and 12 months|Intent a preventive treatment against cavities to avoid endodoncies with different treatments and see which one is more effective after 12 months follow up.|||Participants|||Count of Participants
2573673|NCT02492802|Primary|C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L|Posaconazole drug exposure during treatment in different stages of inflammation. To determine the differences in concentrations between patients a random additive effect was used. Additionally, to correct for differences in intervals between observations a first-order autoregressive correlation was used. The Wald type III test was used to assess the influence of inflammation on posaconazole concentration.|6 months after start of treatment||||mg/L||Inter-Quartile Range|Median
2573674|NCT02492763|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12|This change from baseline reflects the Week 12 DBP minus the Week 0 DBP.|Baseline and Week 12|All randomized, treated participants with at least one DBP measurement (baseline or post-baseline).|||mmHg||95% Confidence Interval|Least Squares Mean
2573681|NCT02492763|Primary|Change From Baseline in Heart Rate at Week 12|This change from baseline reflects the Week 12 heart rate minus the Week 0 heart rate.|Baseline and Week 12|All randomized, treated participants with at least one heart rate measurement (baseline or post-baseline).|||Beats/minute||95% Confidence Interval|Least Squares Mean
2573682|NCT02492763|Primary|Number of Participants With an AE of Symptomatic Hypoglycemia|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Hypoglycemia episodes are those with glucose values ≤70 mg/dL (3.9 mmol/L). Symptomatic hypoglycemia episodes were episodes with clinical symptoms reported by the investigator as hypoglycemia and classified as adverse events.|Up to Week 14|All randomized participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2573683|NCT02492763|Primary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 12|All randomized participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2573684|NCT02492763|Primary|Number of Participants With an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 14|All randomized participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2573685|NCT02492763|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 12|A1C is the percentage of hemoglobin that has glucose bound to it and is a blood marker used to report average blood glucose levels over prolonged periods of time. A1C is reported as a percentage (%). This change from baseline reflects the Week 12 A1C minus the Week 0 A1C.|Baseline and Week 12|All randomized, treated participants with at least one A1C measurement (baseline or post-baseline).|||Percent||95% Confidence Interval|Least Squares Mean
2573686|NCT02492750|Primary|Best Response|The following response terms will be used: stringent Complete Response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), Minimal Response (MR), stable disease (SD), and progressive disease (PD). The International Myeloma Working Group (IMWG) uniform response criteria (Rajkumar et al, 2011) will be used to assess response to therapy. PR defined as: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24hrs; ≥ 50% reduction in the size of soft tissue plasmacytomas. MR defined as: ≥25% but ≤ 49% reduction of serum M protein and reduction in 24-hour urine M-protein by 50-89% which still exceeds 200mg/24 hours; 25-49% reduction in the size of soft tissue plasmacytoma and No increase in the size or number of lytic bone lesions. VGPR defined as: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein <100 mg/24 h|Up to 41 months||||Participants|||Count of Participants
2573687|NCT02492750|Primary|Number of Participants Who Experienced at Least One Grade 3+ Adverse Events Deemed at Least Possibly Related to Treatment, Graded According to NCI CTCAE Version 4.0|The number of participants who experienced at least one grade 3+ adverse events deemed at least possibly related to treatment, graded according to NCI CTCAE version 4.0, is reported below.|Up to 41 months||||Participants|||Count of Participants
2573688|NCT02492750|Primary|Number of Participants Experiencing a Dose-limiting Toxicity (DLT)|Number of participants experiencing a dose-limiting toxicity (DLT) is reported below. Dose-limiting toxicity is graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|28 days||||Participants|||Count of Participants
2573689|NCT02492451|Primary|Pregnancy Rate|ongoing pregnancy rates|12 weeks||||percentage of ongoing pregnancies|||Number
2573690|NCT02492295|Secondary|Hypercarbia: End Tidal Carbon Dioxide (ETCO2) of >50 mm Hg|ETCO2 of >50 mm Hg up to 60 minutes after propofol administration or until patient is fully alert.|60 minutes|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2573691|NCT02492295|Secondary|Number of Patients With Allergic (Anaphylactic-spectrum) Reactions That May be Attributed to Propofol Use (Composite)|Assessed by questionnaire filled out by research associate during and after drug administration. The number of patients (if any) with an anaphylactic-spectrum response will be reported as a composite number, and in the text we will provide a specific description of the reaction(s), which might include itching, urticaria, airway swelling, or wheezing/stridor. Please note that we *do not* anticipate any such reactions to propofol, and thus are not going to pre-specificy these reactions individually as separate outcome measures, but will instead report a composite, with relevant details in the text.|60 minutes|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2573692|NCT02492295|Secondary|Number of Patients Needing Advanced Airway Intervention (Beyond Simple Repositioning)(Composite)|Assessed by questionnaire filled out by research associate during drug administration. Will report the composite number of patients (if any) who required an advanced airway maneuver, specifically insertion of a nasal-pharyngeal airway (NPA) or oro-pharyngeal airway (OPA), use of a bag-valve-mask (BVM), endotracheal intubation (ETT) or surgical airway. While only a composite number will be reported as a secondary outcome, we will give details in the text of any such interventions. We *do not* anticipate that any such interventions will be required during the study, and thus are not going to pre-specify the above interventions as separate individual outcome measures, but will instead report a composite number, with relevant details in the text.|60 minutes|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2573693|NCT02492295|Secondary|Number of Patients Needing Basic Airway Repositioning Maneuver During Sedation|Assessed by questionaire filled out by research associate during drug administration. This Will report the number of patients who required a basic airway repositioning maneuver (jaw thrust/head tilt) during the course of the sedation.|60 minutes|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2573696|NCT02492295|Secondary|Emergency Room Re-admissions|May reflect treatment failure or occurrence of adverse events/reactions-determined by Response is Yes or No|72 hours|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2573697|NCT02492295|Secondary|Patient Willingness to Use Propofol Again in Case of Refractory Migraine as Assessed by Patient Questionaire|Assessed by questionnaire read to patient over phone (yes/no answer)|24 hours|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2573698|NCT02492295|Secondary|Additional Rescue Medications Used|Need for other pain relief medications for migraine after use of propofol|24 hours|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2573699|NCT02492295|Secondary|Pain Assessed by Numeric Pain Score|Numeric pain score 30 minutes after completion of propofol administration.|30 minutes|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2573700|NCT02492295|Secondary|Pain Assessed by Numeric Pain Score|Numeric Pain Score|24 hours|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2573701|NCT02492295|Primary|Pain Assessed by Numeric Pain Score|Numeric pain score 1 hour after completion of propofol administration.|60 minutes|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2573702|NCT02492165|Primary|Summary of Geometric Mean Titers of Japanese Encephalitis Antibodies Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set.|||Titers (1/dil)||95% Confidence Interval|Geometric Mean
2573703|NCT02492165|Primary|Percentage of Participants With Japanese Encephalitis Seroconversion Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) and post-vaccination titer ≥10 (1/dil) or participants with pre vaccination titer ≥10 (1/dil) and a ≥4-fold increase from pre- to post-vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroconversion was assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
2573704|NCT02492165|Primary|Percentage of Participants With Japanese Encephalitis Seroprotection Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|Neutralizing antibodies were measured using a Japanese encephalitis chimeric virus (JE CV) 50% plaque reduction neutralization test (PRNT50). Seroprotection was defined as antibody titer levels ≥10 (1/dil).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection was assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
2573705|NCT02492165|Primary|Number of Participants With Solicited Injection Site Reactions and Systemic Events Following a Single Primary Dose of a Live Attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®)|"Solicited injection-site: ≤ 23 months age: Tenderness, Erythema, and Swelling. For ≥ 2 years age: Pain, Erythema, and Swelling. Solicited systemic reactions: ≤ 23 months age, Fever (temperature) Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability, For ≥ 2 years age, Fever (temperature) Headache, Malaise, and Myalgia.~Grade 3: Tenderness, Cries when injected limb is moved; Pain, Incapacitating, unable to perform usual activities or Significant; prevents daily activity (≥ 12 years); Erythema and Swelling (≤23 months to 11 years), ≥50 mm or >100 mm (≥ 12 years).~Grade 3 Fever, > 39.5°C (≤ 23 months) or ≥39.0°C (≥ 2 years); Vomiting, ≥ 6 episodes per 24 hours; Crying abnormal, > 3 hours; Drowsiness, Sleeping most of the time; Appetite loss, Refuses ≥ 3 feeds / meals; Irritability, Inconsolable. Headache, Malaise, and Myalgia, Significant; prevents daily activity."|Day 0 up to Day 14 post-vaccination|Solicited injection site and solicited systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
2573706|NCT02492100|Secondary|Change in Psychological Distress Scores - Hospital and Anxiety Depression Scale and Patient Health Questionnaire-9|change in HADS depression score, depression subscale of the HADS has a score range of 0-21, with higher scores indicating more depression symptoms.|Baseline to 6 Months||||units on a scale||Standard Deviation|Mean
2573707|NCT02492100|Secondary|Change in Quality of Life: Functional Assessment of Cancer Therapy- Bone Marrow Transplant|quality of life at 6 months compared to baseline using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant. Score range 0-164 with higher score indicating better quality of life.|Baseline to 6 Months||||units on a scale||Standard Deviation|Mean
2573708|NCT02492100|Secondary|Change in Sexual Function: Promis Sexual Function and Satisfaction Measure|Interest in sex at 6 months, raw score range 2-20 with higher scores indicating higher interest.|Baseline to 6 Months||||units on a scale||Standard Deviation|Mean
2573709|NCT02492100|Primary|Feasibility Primary Endpoint|intervention deemed feasible if at least 75% of patients screening positive for sexual dysfunction causing distress agree to participate and at least 80% complete at least one additional follow-up visit. This is not a composite outcome. Study is deemed feasible (yes) if both criteria are met.|6 months|overall 94% (47 of 50) patients who screened positive for sexual dysfunction agreed to participate in the study and 80% attended at least 2 intervention visits|||Participants|||Count of Participants
2573710|NCT02491944|Secondary|CL for [14C]AZD9291|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of total body clearance of drug from plasma after intravascular administration (CL) for [14C]AZD9291.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||L/h||Standard Deviation|Mean
2573798|NCT02491359|Secondary|Treatment Success|Treatment success will be estimated at 1 year with a composite outcome of complete resolution of all reversible chronic GVHD manifestations, discontinuation of all systemic immune suppressive agents, and freedom from death or primary malignancy relapse after transplant.|1 year||||participants|||Number
2573711|NCT02491944|Secondary|t1/2,λz for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of the elimination half life (t1/2,λz) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||hours||Standard Deviation|Mean
2573712|NCT02491944|Secondary|Tmax for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of the the time to maximum observed plasma concentration (Tmax) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||hours||Full Range|Median
2573713|NCT02491944|Secondary|Cmax for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of the maximum observed plasma concentration (Cmax) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM*eq||Geometric Coefficient of Variation|Geometric Mean
2573714|NCT02491944|Secondary|AUC(0-t) for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to the last quantifiable concentration (AUC 0-t) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM*eq*h||Geometric Coefficient of Variation|Geometric Mean
2573715|NCT02491944|Secondary|AUC(0-120) for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to 120 hours (AUC 0-120) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM*eq*h||Geometric Coefficient of Variation|Geometric Mean
2573716|NCT02491944|Secondary|AUC(0-24) for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to 24 hours (AUC 0-24) for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM*eq*h||Geometric Coefficient of Variation|Geometric Mean
2573717|NCT02491944|Secondary|AUC for [14C]AZD9291 and it's Metabolites [14C]AZ5104 and [14C]AZ7550|Pharmacokinetic (PK) profile of the IV dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from zero to infinity for [14C]AZD9291 and it's metabolites [14C]AZ5104 and [14C]AZ7550.|Samples taken pre-dose, during the infusion, immediately at the end of infusion and then at 5, 10, 20, 25 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 42, 66, 114, 162, 210, 330 and 498 hours after the end of the infusion.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM*eq*h||Geometric Coefficient of Variation|Geometric Mean
2573718|NCT02491944|Secondary|CL/F for AZD9291|PK profile of the oral dose of AZD9291 in terms of apparent total body clearance of drug from plasma after extravascular administration(CL/F) for AZD9291.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||L/h||Standard Deviation|Mean
2573719|NCT02491944|Secondary|t1/2,λz for AZD9291 and it's Metabolites AZ5104 and AZ7550|PK profile of the oral dose of AZD9291 in terms of the elimination half life (t1/2,λz) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||hours||Standard Deviation|Mean
2573799|NCT02491359|Secondary|Probability of Overall Survival at 1 Year|Kaplan-Meier estimate assessed at 1 year for overall survival, defined as absence of death from any cause.|1 year||||probability of overall survival|||Number
2573720|NCT02491944|Secondary|Tmax for AZD9291 and it's Metabolites AZ5104 and AZ7550|PK profile of the oral dose of AZD9291 in terms of the time to maximum observed plasma concentration (Tmax) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||hours||Full Range|Median
2573721|NCT02491944|Secondary|Cmax for AZD9291 and it's Metabolites AZ5104 and AZ7550|PK profile of the oral dose of AZD9291 in terms of the maximum observed plasma concentration (Cmax) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM||Geometric Coefficient of Variation|Geometric Mean
2573722|NCT02491944|Secondary|AUC(0-t) for AZD9291 and it's Metabolites AZ5104 and AZ7550|Pharmacokinetic (PK) profile of the oral dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to the last quantifiable concentration (AUC 0-t) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
2573723|NCT02491944|Secondary|AUC(0-120) for AZD9291 and it's Metabolites AZ5104 and AZ7550|Pharmacokinetic (PK) profile of the oral dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to 120 hours (AUC 0-120) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
2573724|NCT02491944|Secondary|AUC(0-24) for AZD9291 and it's Metabolites AZ5104 and AZ7550|Pharmacokinetic (PK) profile of the oral dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from time zero to 24 hours (AUC 0-24) for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
2573725|NCT02491944|Secondary|AUC for AZD9291 and it's Metabolites AZ5104 and AZ7550|Pharmacokinetic (PK) profile of the oral dose of AZD9291 in terms of Area under the plasma concentration - time curve (AUC) from zero to infinity for AZD9291 and it's metabolites AZ5104 and AZ7550.|Samples taken at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336 and 504 hours post-dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
2573726|NCT02491944|Primary|Absolute Oral Bioavailability|Absolute bioavailability of AZD9291 will be calculated from area under the plasma concentration versus time curve (AUC) of the oral dose of AZD9291 / AUC of the IV dose of [14C]AZD9291 x IV dose/Oral dose x 100|Samples taken at pre-dose, 1, 2, 3, 4, 5:45, 5:52, 6, 6:05, 6:10, 6:20, 6:25, 6:30, 7, 8, 9, 10, 12, 14, 16, 18, 24, 30, 48, 72, 120, 168, 216, 336 and 504 hours relative to the oral dose.|PK analysis set included all healthy male subjects who received at least 1 dose of AZD9291 and have at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of AZD9291.|||Percentage||90% Confidence Interval|Geometric Mean
2573727|NCT02491892|Secondary|Number of Participants Experiencing a Drop in Left Ventricular Ejection Fraction (LVEF) to a Value of Less Than 50%|Echocardiography was performed to determine LVEF, defined as the volume of blood pumped from the left ventricle as a percentage of end-diastolic volume. Theoretically, LVEF may range from 0 to 100%. The number of participants experiencing a drop in LVEF greater than or equal to (≥) 10 or 15 percentage points to a final LVEF of less than (<) 50% is reported here.|Up to approximately 1 year (at Baseline; at the end of Cycles 2, 4, 8, 12, and 16; and up to 7 weeks following the last infusion)|Safety Population.|||participants|||Number
2573728|NCT02491892|Secondary|Mean Residence Time (MRT) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine the MRT by non-compartmental analysis. The derived value was averaged among all participants and expressed in days.|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.|||days||Standard Deviation|Mean
2573729|NCT02491892|Secondary|Volume of Distribution at Steady State (Vss) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine the Vss by non-compartmental analysis, defined as the theoretical volume at which the total amount of pertuzumab would be uniformly distributed to produce the desired concentration. The derived value was averaged among all participants and expressed in milliliters (mL).|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.|||mL||Standard Deviation|Mean
2573730|NCT02491892|Secondary|Systemic Clearance (CL) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine CL by non-compartmental analysis, defined as the rate at which pertuzumab was removed from the body. The derived value was averaged among all participants and expressed in milliliters per day (mL/day).|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.|||mL/day||Standard Deviation|Mean
2573731|NCT02491892|Secondary|Area Under the Concentration-Time Curve (AUC) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. Pertuzumab concentrations at each collection point were used to determine AUC to the last measurable observation (AUClast) and AUC extrapolated to infinity (AUCinf) by non-compartmental analysis. The derived values were averaged among all participants and expressed in days by micrograms per milliliter (days*mcg/mL).|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis, and the number of participants analyzed (n) is presented here.|||days*mcg/mL||Standard Deviation|Mean
2573732|NCT02491892|Secondary|Time to Maximum Plasma Concentration (Tmax) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. The time of maximum observed pertuzumab concentration across all collection points was documented. Tmax was averaged among all participants and expressed in days.|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.|||days||Full Range|Median
2573733|NCT02491892|Secondary|Maximum Plasma Concentration (Cmax) of Pertuzumab|Serum samples were obtained for PK assessment using a receptor-binding ELISA. The maximum observed pertuzumab concentration across all collection points was documented. Cmax was averaged among all participants and expressed in micrograms per milliliter (mcg/mL).|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.|||mcg/mL||Standard Deviation|Mean
2573734|NCT02491892|Secondary|Apparent Half-Life (t1/2) of Pertuzumab|Serum samples were obtained for pharmacokinetic (PK) assessment using a receptor-binding, enzyme-linked immunosorbent assay (ELISA). Pertuzumab concentrations at each collection point were used to determine the apparent t1/2 by non-compartmental analysis, defined as the time elapsed for pertuzumab concentrations to decrease by 50%. The derived value was averaged among all participants and expressed in days.|Pre-dose and within 15 minutes of the end of infusion on Day 1 of each cycle, and on Days 8 and 15 of Cycles 1 and 2|ITT Population. Participants with missing PK data were excluded from the analysis.|||days||Standard Deviation|Mean
2573735|NCT02491892|Secondary|Percentage of Participants Achieving a Best Overall Response of SD|Objective tumor response was assessed using RECIST. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for PD. The percentage of participants achieving a best overall response of SD was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||percentage of participants|||Number
2573736|NCT02491892|Secondary|Overall Survival|Overall survival was defined as the time from treatment start to death. Participants who did not die during follow-up were to be censored from the last known alive date. Overall survival was to be estimated using Kaplan-Meier.|Up to approximately 2 years (from start of treatment until death)|Median survival was not reached because the study program was terminated early. Analysis of the incomplete data set was not performed because it could potentially produce skewed or statistically irrelevant data.||||||
2573737|NCT02491892|Secondary|Percentage of Participants Who Died|The percentage of participants who died was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to approximately 2 years (from start of treatment until death)|Safety Population: All randomized participants who received at least one dose of pertuzumab and had at least one post-baseline safety assessment.|||percentage of participants|||Number
2573738|NCT02491892|Secondary|Time to Treatment Failure|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Time to treatment failure was defined as the time from treatment start to PD or early withdrawal from the study for death, toxicity, refusal/noncompliance, insufficient therapeutic response, or failure to return. Participants who did not experience PD or who did not withdraw from the study early were censored from the last tumor assessment. Time to treatment failure was estimated using Kaplan-Meier and expressed in weeks.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||weeks||Full Range|Median
2573739|NCT02491892|Secondary|Number of Participants Who Experienced PD or Withdrew From the Study Early|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||participants|||Number
2573740|NCT02491892|Secondary|Time to Progression|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Participants who withdrew from the study early for insufficient therapeutic response without tumor assessment for PD were also included within the definition of PD. Time to progression was defined as the time from treatment start to PD or death. Participants who did not experience PD or death were censored from the last tumor assessment. Time to progression was estimated using Kaplan-Meier and expressed in weeks.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||weeks||Full Range|Median
2573741|NCT02491892|Secondary|Number of Participants Who Experienced PD or Death|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Participants who withdrew from the study early for insufficient therapeutic response without tumor assessment for PD were also included within the definition of PD.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||participants|||Number
2573742|NCT02491892|Secondary|Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR|Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Duration of response was defined as the time from first documented response (ie, CR) to PD or death. Participants who did not experience PD or death were to be censored from the last tumor assessment. Duration of response was to be estimated using Kaplan-Meier.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||weeks||Full Range|Median
2573743|NCT02491892|Secondary|Percentage of Participants Achieving a Best Overall Response of Confirmed CR|Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. The percentage of participants achieving a best overall response of CR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||percentage of participants|||Number
2573744|NCT02491892|Secondary|Duration of Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR|Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all target lesions, and confirmed PR was defined as at least at 30% decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Duration of response was defined as the time from first documented response (ie, CR or PR) to PD or death. Participants who did not experience PD or death were censored from the last tumor assessment. Duration of response was estimated using Kaplan-Meier and expressed in weeks.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||weeks||Full Range|Median
2573745|NCT02491892|Secondary|Time to Response Among Participants Achieving a Best Overall Response of Confirmed CR or PR|Objective tumor response was assessed using RECIST. Confirmed CR was defined as the disappearance of all target lesions, and confirmed PR was defined as at least at 30% decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Time to response was defined as the time from treatment start to first documented response (ie, CR or PR). Participants with stable disease (SD) were censored from the last tumor assessment, and those with progressive disease (PD) or death were assigned an artificial censoring time of 1000 days. Time to response was estimated using Kaplan-Meier and expressed in weeks.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||weeks||Full Range|Median
2573746|NCT02491892|Primary|Percentage of Participants Achieving a Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR)|Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR was defined as the disappearance of all target lesions, and confirmed PR was defined as at least at 30 percent (%) decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. The percentage of participants achieving a best overall response of CR or PR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 1 year (at Baseline; every 6 weeks for the first 8 cycles, then every 12 weeks until progression or death; and up to 4 weeks after initial response)|ITT Population.|||percentage of participants|||Number
2573747|NCT02491684|Secondary|AUC for Change in the Evening FEV1 From Baseline up to 30 Days|"Patients measured evening FEV1 at home and recorded the results using the ePRO device. Baseline assessments were taken as the last non-missing assessment prior to randomisation.~The mean AUC for change from baseline is presented for the periods Days 1-14, 1-7, 8-14 and 15-30."|From baseline up to 30 days after start of treatment phase.|"The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.~Patients with non-missing values were included in the analysis."|||litres||Standard Error|Least Squares Mean
2573748|NCT02491684|Secondary|AUC for Change in the Evening PEF From Baseline to up to 30 Days|"Patients measured evening PEF at home and recorded the results using the ePRO device. Baseline assessments were taken as the last non-missing assessment prior to randomisation.~The mean AUC for change from baseline is presented for the periods Days 1-14, 1-7, 8-14 and 15-30."|From baseline up to 30 days after start of treatment phase.|"The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.~Patients with non-missing values were included in the analysis."|||l/min||Standard Error|Least Squares Mean
2573749|NCT02491684|Secondary|AUC for Change in the Morning Forced Expiratory Volume in 1 Second (FEV1) From Baseline up to 30 Days|"Patients measured morning FEV1 at home and recorded the results using the ePRO device. Baseline assessments were taken as the last non-missing assessment prior to randomisation.~The mean AUC for change from baseline is presented for the periods Days 1-14, 1-7, 8-14 and 15-30."|From baseline up to 30 days after start of treatment phase.|"The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.~Patients with non-missing values were included in the analysis."|||litres||Standard Error|Least Squares Mean
2573750|NCT02491684|Secondary|AUC for Change in the Morning Peak Expiratory Flow (PEF) From Baseline to up to 30 Days|"Patients measured morning PEF at home and recorded the results using the ePRO device. Baseline assessments were taken as the last non-missing assessment prior to randomisation.~The mean AUC for change from baseline is presented for the periods Days 1-14, 1-7, 8-14 and 15-30."|From baseline up to 30 days after start of treatment phase.|"The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.~Patients with non-missing values were included in the analysis."|||litres/minute (l/min)||Standard Error|Least Squares Mean
2573751|NCT02491684|Secondary|AUC for Change in Daytime and Night-time Reliever Medication Use From Baseline up to 14 Days|"Patients recorded the number of reliever medication inhalations taken twice daily in the Asthma Daily Diary. The number of inhalations taken between the morning and evening lung function assessments were recorded in the evening. The number of inhalations taken between the evening and morning lung function assessments were recorded in the morning. Baseline assessments were taken as the last non-missing assessment prior to randomisation.~The AUC for change from baseline over Days 1-14 (inclusive of Days 1 and 14) is presented."|From baseline up to Day 14 of treatment phase.|"The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.~Patients with non-missing values were included in the analysis."|||Inhalations||Standard Error|Least Squares Mean
2573752|NCT02491684|Secondary|Change in Health-related Quality of Life as Measured by the Asthma Quality of Life Questionnaire (AQLQ[S]) From Baseline up to 30 Days|"The AQLQ(S) was used to assess health-related quality of life and consisted of 32 questions. Patients were asked to score each of the questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The questions were allocated to 4 domains assessing:~activity limitation,~symptoms,~emotional function, and~environmental stimuli~The overall score was calculated as the mean of the responses to all questions. The mean change in overall score from baseline at Visit 6 (Day 14+/-1) and Visit 8 (Day 30) are presented."|From baseline up to 30 days after start of treatment phase.|"The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.~Patients with non-missing values were included in the analysis."|||Units on Scale||Standard Error|Least Squares Mean
2573753|NCT02491684|Secondary|Change in the Proportion of Night-time Awakening Using the ePRO Questionnaire From Baseline up to 30 Days|"Night-time awakenings due to asthma symptoms were recorded by the patient in the Asthma Daily Diary each morning by answering the question whether he/she woke up during the night due to asthma symptoms with a 'yes' or 'no' response.~Biweekly means were calculated as the percentages of times the subject answered 'yes' over a period of 14 sequential days. Biweekly means are presented for the periods over Days 2-15 and Days 16-30."|From baseline up to 30 days after start of treatment phase.|"The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.~Patients with non-missing values were included in the analysis."|||Percentage of 'yes' responses||Standard Deviation|Mean
2573754|NCT02491684|Secondary|AUC for Change in Daytime and Night-time Asthma Symptom Score From Baseline up to 30 Days|Asthma symptoms during night-time and daytime were recorded by the patient each morning and evening in the Asthma Daily Diary on a daily basis. Symptoms were recorded using a scale of 0 to 3 where 0 indicates no asthma symptoms up to an absolute score of 3. Baseline assessments were taken as the last non-missing assessment prior to randomisation. The total daily asthma symptom score was calculated by taking the sum of the night-time and daytime asthma scores recorded each day. The outcome variable is the area under the curve (AUC) for change from baseline in day-time, night-time and total daily asthma symptom scores over Days 1-14, Days 1-7, Days 8-14 and Days 15-30.|From baseline up to 30 days after start of treatment phase.|"The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.~Patients with non-missing values were included in the analysis."|||Units on Scale||Standard Error|Least Squares Mean
2573755|NCT02491684|Secondary|Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6)|"The ACQ-6 consists of 6 questions to assess asthma control, each question measured on a 7-point scale scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 total score is computed as the un-weighted mean of the responses to the 6 questions. Baseline assessments were taken as the last non-missing assessment prior to randomisation.~The change from baseline at Visit 4 (Day 7 +/- 1), at Visit 6 (Day 14 +/- 1) and at Visit 8 (Day 30) is presented for the total score and for each of the 6 questions."|From baseline up to 30 days after start of treatment phase.|"The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.~Patients with non-missing values were included in the analysis."|||Units on a Scale||Standard Error|Least Squares Mean
2573756|NCT02491684|Secondary|Duration of Moderate or Severe Exacerbations|"The duration of each individual moderate or severe exacerbation was calculated as:~Cessation date of exacerbation - Start date of exacerbation + 1.~The start date of a severe exacerbation was defined as the start date of systemic corticosteroids or increase of systemic corticosteroids or emergency room visit or hospital admission, whichever occurred first. The stop date was defined as the last day of systemic corticosteroids/increase of systemic corticosteroids or hospital discharge, whichever occurred last.~The start date of a moderate exacerbation was defined as the first day of increase in temporary maintenance therapy. The stop date was defined as the last day of this treatment.~The mean duration of moderate or severe exacerbations is presented for each treatment group."|Day 1 of treatment phase up to 30 days post-randomisation.|"The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.~The number of patients in the analysis are those with at least 1 exacerbation."|||Days||Standard Deviation|Mean
2573757|NCT02491684|Secondary|Time to First Moderate Asthma Exacerbation During 30 Days Following Randomisation|"The time to first event was calculated as start date of events - date of randomisation + 1.~Patients with no observed event were censored at the date of their last visit, or for lost-to-follow-up patients, at the last time point after which an event could not be assessed.~The median time to first exacerbation was not calculated in either treatment group due to low numbers of events."|From Day 1 of treatment phase up to 30 days post-randomisation.|The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.|||Days||Full Range|Median
2573758|NCT02491684|Secondary|Time to First Severe Asthma Exacerbation During 30 Days Following Randomisation|"The time to first event was calculated as start date of events - date of randomisation + 1.~Patients with no observed event were censored at the date of their last visit, or for lost-to-follow-up patients, at the last time point after which an event could not be assessed.~The median time to first exacerbation was not calculated in either treatment group due to low numbers of events."|From Day 1 of treatment phase up to 30 days post-randomisation.|The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.|||Days||Full Range|Median
2573759|NCT02491684|Secondary|Proportion of Patients With Moderate Asthma Exacerbation Within 7, 14 and 30 Days Following Randomisation|"Evaluation of the efficacy of inhaled AZD9412 compared to placebo in preventing moderate exacerbations within 7, 14 and 30 days after the start of treatment (Day 1).~A moderate exacerbation was defined as a temporary increase in maintenance therapy in order to prevent a severe event supported by a sustained (2 or more days) worsening in at least one key control metric, including asthma score, rescue use, night time awakening or morning peak expiratory flow.~The numbers of patients with moderate exacerbations with onset during Days 1 - 7, Days 1 - 14 and Days 1 - 30 are presented for each treatment group.~With respect to the Day 1-7 analysis, the model did not converge so the analysis could not be performed."|Day 1 of treatment phase up to 30 days post-randomisation.|The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.|||Participants|||Count of Participants
2573760|NCT02491684|Secondary|Proportion of Patients With Severe Asthma Exacerbations Within 7 and 30 Days Following Randomisation|"Evaluation of the efficacy of inhaled AZD9412 compared to placebo in preventing severe exacerbations within 7 and 30 days after the start of treatment (Day 1).~A severe exacerbation was defined as worsening asthma symptoms and~use of systemic corticosteroids (or a temporary increase of at least 2-fold in a stable oral corticosteroid background dose) for at least 3 consecutive days and/or~an unscheduled visit or emergency room visit due to asthma symptoms that required at least 1 dose of systemic corticosteroids and/or~an in-patient hospitalisation due to asthma requiring at least 1 dose of systemic corticosteroids.~The numbers of patients with severe asthma exacerbations with onset during Days 1 - 7 and Days 1 - 30 are presented for each treatment group."|Day 1 of treatment phase up to 30 days post-randomisation.|The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.|||Participants|||Count of Participants
2573761|NCT02491684|Primary|Proportion of Patients With a Severe Asthma Exacerbation During 14 Days of Treatment|"Evaluation of the efficacy of inhaled AZD9412 compared to placebo in preventing severe exacerbations during the 14 day treatment phase following the onset of an URTI in asthmatic patients.~A severe exacerbation was defined as worsening asthma symptoms and~use of systemic corticosteroids (or a temporary increase of at least 2-fold in a stable oral corticosteroid background dose) for at least 3 consecutive days and/or~an unscheduled visit or emergency room visit due to asthma symptoms that required at least 1 dose of systemic corticosteroids and/or~an in-patient hospitalisation due to asthma requiring at least 1 dose of systemic corticosteroids.~The number of patients with severe asthma exacerbations with onset during the treatment phase is presented for each treatment group."|Day 1 - 14 of the treatment phase.|The Intention to treat (ITT) analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available.|||Participants|||Count of Participants
2573762|NCT02491463|Secondary|Frequency of Anti-F Immunoglobulin g (IgG) and/or Immunoglobulin A (IgA) Antibody Secreting B-cells (ASC)|IgG/IgA antibody specific B-cells/ expressed as B-cells per million cells, were determined by the ELISpot assay.|At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.|||B-cells/million cells||Inter-Quartile Range|Median
2573763|NCT02491463|Secondary|Frequency of RSV Viral Protein F, N, M2-1 Specific Interferon-gamma (IFN-γ) Secreting T-cells|Interferon-gamma specific T-cells, expressed as T-cells per (/) million cells, were determined by the Enzyme Linked ImmunoSpot (ELISpot) assay.|At pre-vaccination (Day 0) and post-Dose 1 (Day 7, Day 30) and post-Dose 2 (Day 37, Day 60)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.|||T-cells/million cells||Inter-Quartile Range|Median
2573764|NCT02491463|Secondary|Number of Subjects With Anti-RSV Neutralizing Antibodies Above the Cut-off Value|Pre-defined cut-off values was higher than or equal to (≥) 8 ED60.|At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.|||Participants|||Count of Participants
2573765|NCT02491463|Secondary|Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibodies Titers|Serum neutralizing antibody titers were reported as the inverse of the serum dilution which yielded a 60% reduction in the number of viral plaques compared to virus control without serum (Estimated Dilution: ED60). Antibody titers were expressed as Geometric Mean Titers (GMTs).|At pre-vaccination (Day 0), post-Dose 1 (Day 30) and post-Dose 2 (Day 60)|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects, i.e. those who were included in the Total Vaccinated Cohort and who received at least one dose of study vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2573766|NCT02491463|Secondary|Number of Subjects With Haematological and Biochemical Results by Maximum Grade|Parameters analysed were ALT, activated partial thromboplastin time [APTT], AST, total bilirubin [TB], CRE, EOS, haemoglobin decrease [HgD], LYM, NEU, platelets [PLA], PT, white blood cells decrease [WBCD] and white blood cells increase [WBCI]. Assessed grades were: Unknown [UG], grade 0 [G0] = no grade, 1 [G1] = mild grade, 2 [G2] = moderate grade, 3 [G3] = severe grade, 4 [G4] = potentially life threatening and overall grading [GTotal]. Parameter grade combinations expressed were: parameter plus UG/G0/1/2/3/4/Total at baseline versus grading G0/1/2/3/4/Total from Day 1 up to Day 360, for the same parameter, e.g. ALT G0-G2.|From Day 1 up to Day 360|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented.|||Participants|||Count of Participants
2573767|NCT02491463|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 to Day 360|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented.|||Participants|||Count of Participants
2573768|NCT02491463|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented.|||Participants|||Count of Participants
2573769|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Results by Maximum Grade|Parameters analysed were ALT, activated partial thromboplastin time [APTT], AST, total bilirubin [TB], CRE, EOS, haemoglobin decrease [HgD], LYM, NEU, platelets [PLA], PT, white blood cells decrease [WBCD] and white blood cells increase [WBCI]. Assessed grades were: Unknown [UG], grade 0 [G0] = no grade, 1 [G1] = mild grade, 2 [G2] = moderate grade, 3 [G3] = severe grade, 4 [G4] = potentially life threatening and overall grading [GTotal]. Parameter grade combinations expressed were: parameter plus UG/G0/1/2/3/4/Total at baseline versus grading G0/1/2/3/4/Total from Day 1 up to Day 60, for the same parameter, e.g. ALT G0-G2.|From Day 1 to Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented.|||Participants|||Count of Participants
2573770|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day360(U-B), unknown at baseline and within at Day360(U-W), unknown at baseline and above at Day360(U-A), below at baseline and below at Day360(B-B), below at baseline and within at Day360(B-W),below at baseline and above at Day360(B-A), within at baseline and below at Day360(W-B),within at baseline and within at Day360(W-W), within at baseline and above at Day360(W-A),above at baseline and below at Day360(A-B),above at baseline and within at Day360(A-W),above at baseline and above at Day360(A-A).|At Day 360|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented and with available results at Day 360.|||Participants|||Count of Participants
2573771|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day180(U-B), unknown at baseline and within at Day180(U-W), unknown at baseline and above at Day180(U-A), below at baseline and below at Day180(B-B), below at baseline and within at Day180(B-W),below at baseline and above at Day180(B-A), within at baseline and below at Day180(W-B),within at baseline and within at Day180(W-W), within at baseline and above at Day180(W-A),above at baseline and below at Day180(A-B),above at baseline and within at Day180(A-W),above at baseline and above at Day180(A-A).|At Day 180|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented and with available results at Day 180.|||Participants|||Count of Participants
2573772|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 60(U-B), unknown at baseline and within at Day60(U-W), unknown at baseline and above at Day 60(U-A), below at baseline and below at Day60(B-B), below at baseline and within at Day60(B-W), below at baseline and above at Day60(B-A), within at baseline and below at Day 60(W-B), within at baseline and within at Day 60(W-W), within at baseline and above at Day60(W-A), above at baseline and below at Day60(A-B), above at baseline and within at Day60(A-W), above at baseline and above at Day60(A-A).|At Day 60|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 60.|||Participants|||Count of Participants
2573773|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 37(U-B), unknown at baseline and within at Day37(U-W), unknown at baseline and above at Day 37(U-A), below at baseline and below at Day37(B-B), below at baseline and within at Day37(B-W), below at baseline and above at Day 37(B-A), within at baseline and below at Day 37(W-B), within at baseline and within at Day 37(W-W), within at baseline and above at Day37(W-A), above at baseline and below at Day37(A-B), above at baseline and within at Day37(A-W), above at baseline and above at Day37(A-A).|At Day 37|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 37.|||Participants|||Count of Participants
2573795|NCT02491359|Secondary|Symptoms as Measured by Patient Self-report--Functional Assessment of Chronic Illness Therapy (FACT)|"FACT-BMT subscales have various min/max, see below; results given are actual 12mo scores, with higher scores indicating better functioning.~FACT physical well-being (0-28) FACT social/family well-being (0-28) FACT emotional well-being (0-24) FACT functional well-being (0-28) FACT Bone Marrow Transplant (BMT) subscale (0-40) FACT trial outcome index (0-96) FACT-General (G) (0-108) FACT-BMT total (0-148)"|baseline|Only baseline surveys analyzed. Only 7 patients completed surveys at 6mo, not analyzed due to low number.|||units on a scale||Full Range|Median
2573774|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 33(U-B), unknown at baseline and within at Day33(U-W), unknown at baseline and above at Day 33(U-A), below at baseline and below at Day33(B-B), below at baseline and within at Day33(B-W), below at baseline and above at Day 33 (B-A), within at baseline and below at Day 33(W-B), within at baseline and within at Day 33(W-W), within at baseline and above at Day33(W-A), above at baseline and below at Day33(A-B), above at baseline and within at Day33(A-W), above at baseline and above at Day33(A-A).|At Day 33|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 33.|||Participants|||Count of Participants
2573775|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 31(U-B), unknown at baseline and within at Day31(U-W), unknown at baseline and above at Day 31(U-A), below at baseline and below at Day31(B-B), below at baseline and within at Day31(B-W), below at baseline and above at Day 31(B-A), within at baseline and below at Day 31(W-B), within at baseline and within at Day 31(W-W), within at baseline and above at Day31(W-A), above at baseline and below at Day31(A-B), above at baseline and within at Day31(A-W), above at baseline and above at Day31(A-A).|At Day 31|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 31.|||Participants|||Count of Participants
2573776|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 30(U-B), unknown at baseline and within at Day30(U-W), unknown at baseline and above at Day 30(U-A), below at baseline and below at Day30(B-B), below at baseline and within at Day30(B-W), below at baseline and above at Day 30(B-A), within at baseline and below at Day 30 (W-B), within at baseline and within at Day 30(W-W), within at baseline and above at Day30(W-A), above at baseline and below at Day30(A-B), above at baseline and within at Day30(A-W), above at baseline and above at Day30(A-A).|At Day 30|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 30.|||Participants|||Count of Participants
2573777|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/ Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 7 (U-B), unknown at baseline and within at Day 7 (U-W), unknown at baseline and above at Day 7 (U-A), below at baseline and below at Day 7 (B-B), below at baseline and within at Day 7 (B-W), below at baseline and above at Day 7(B-A), within at baseline and below at Day 7 (W-B), within at baseline and within at Day 7(W-W), within at baseline and above at Day 7(W-A), above at baseline and below at Day 7(A-B), above at baseline and within at Day 7(A-W), above at baseline and above at Day 7(A-A).|At Day 7|The analysis was performed on the Total Vaccinated cohort which which included all subjects with at least one study vaccine administration documented and with available results at Day 7.|||Participants|||Count of Participants
2573778|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/ Biochemical parameters assessed were haemoglobin level [HgL], red blood cell [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 3 (U-B), unknown at baseline and within at Day 3 (U-W), unknown at baseline and above at Day 3 (U-A), below at baseline and below at Day 3 (B-B), below at baseline and within at Day 3 (B-W), below at baseline and above at Day 3(B-A), within at baseline and below at Day 3 (W-B), within at baseline and within at Day 3(W-W), within at baseline and above at Day 3(W-A), above at baseline and below at Day 3(A-B), above at baseline and within at Day 3(A-W), above at baseline and above at Day 3(A-A).|At Day 3|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 3.|||Participants|||Count of Participants
2573794|NCT02491359|Secondary|Symptoms as Measured by Patient Self-report--Human Activities Profile (HAP)|"HAP subscales have min=0 and max=94; results given are actual 12mo scores, with higher scores indicating better functioning.~Maximum Activity Score (MAS) is highest item number answered still doing. Represents highest oxygen demanding activity that respondent still performs.~Adjusted Activity Score (AAS) is MAS minus total number of stopped doing responses below MAS. A measure of usual daily activities.~Modified AAS is MAS minus total number of stopped doing responses below MAS but not penalized for not doing activities not permitted post transplant. The following items are not counted against the score:11,15,19,20,22,25,34,41,42,47,49,50,52,53,54,57,72,73,77,78."|baseline|Only baseline surveys analyzed. Only 7 patients completed surveys at 6mo, not analyzed due to low number.|||units on a scale||Full Range|Median
2573779|NCT02491463|Primary|Number of Subjects With Haematological and Biochemical Laboratory Abnormalities|Haematological/Biochemical parameters assessed were haemoglobin level [HgL], red blood cells [RBC], white blood cell [WBC], lymphocyte [LYM], neutrophil [NEU], eosinophil [EOS], reticulocyte [RET], platelet count [PLC], haptoglobin [Hpg], prothrombin time [PT] and partial thromboplastin time [PTT]. alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine [CRE], lactate dehydrogenase [LDH] and bilirubin direct or total [BLD/BLT].Values were: unknown at baseline and below at Day 1 (U-B), unknown at baseline and within at Day 1 (U-W), unknown at baseline and above at Day 1 (U-A), below at baseline and below at Day 1 (B-B), below at baseline and within at Day 1 (B-W), below at baseline and above at Day 1(B-A), within at baseline and below at Day 1 (W-B), within at baseline and within at Day 1(W-W), within at baseline and above at Day 1(W-A), above at baseline and below at Day 1(A-B), above at baseline and within at Day 1 (A-W), above at baseline and above at Day 1(A-A)|At Day 1|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented and with available results at Day 1.|||Participants|||Count of Participants
2573780|NCT02491463|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)] gastrointestinal symptoms (gastro) [nausea, vomiting, diarrhoea and/or abdominal pain] and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one study vaccine administration documented, who had filled in their symptom sheets.|||Participants|||Count of Participants
2573781|NCT02491463|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administration documented, who had filled in their symptom sheets.|||Participants|||Count of Participants
2573782|NCT02491437|Secondary|Physical Examination Newborn (Number of Delivered Newborns That Are Male or Female)|The gender (number of delivered newborns that are male or female)|After delivery (about 9 months after IVF)|Full Analysis Sample (FAS). These are the number of delivered babies from the mothers in the FAS|||number of newborns|||Number
2573783|NCT02491437|Secondary|Rate of Successful Completion of Pregnancy (Percentage of Participants With a Live Birth)|Live birth rate (percentage of participants with a live birth)|After delivery (about 9 months after IVF)|Full Analysis Sample (FAS)|||percentage of participants||95% Confidence Interval|Number
2573784|NCT02491437|Secondary|Positive Pregnancy Test Rate (Percentage of Participants With a Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer)|Positive biochemical pregnancy test on Day 14 after embryo transfer|Day 14 after embryo transfer|Full Analysis Sample (FAS)|||percentage of participants||95% Confidence Interval|Number
2573785|NCT02491437|Primary|Percentage of Participants With Presence of Fetal Heart Beats at 12 Week's Gestation Determined by Transvaginal Ultrasound|Pregnancy rate defined as the presence of fetal heart beats at 12 weeks' gestation determined by transvaginal ultrasound.|12 weeks´ gestation|Full Analysis Sample (FAS)|||percentage of participants||95% Confidence Interval|Number
2573786|NCT02491411|Secondary|Time to Radiographic Progression for Treatment With Dexamethasone|Will be summarized using Kaplan-Meier approach.|Up to 4 weeks post-treatment|Data was not collected, the study was terminated early due to lower enrollment.||||||
2573787|NCT02491411|Secondary|Time to PSA Progression, Based Upon PCWG2 Criteria, for Treatment With Dexamethasone|Will be summarized using Kaplan-Meier approach.|Up to 4 weeks post-treatment|Data was not collected, the study was terminated early due to lower enrollment.||||||
2573788|NCT02491411|Secondary|Response Rate With Enzalutamide by AR-V7 Status at Study Entry||Baseline|Data was not collected, the study was terminated early due to lower enrollment.||||||
2573789|NCT02491411|Secondary|Response Rate With Dexamethasone by AR-V7 Status at Study Entry||Baseline|Data was not collected, the study was terminated early due to lower enrollment.||||||
2573790|NCT02491411|Secondary|Objective Response Rate to Enzalutamide in Patients With Measurable Disease on CT Scan|Will estimate 95% confidence interval.|Up to 4 weeks post-treatment|Data was not collected, the study was terminated early due to lower enrollment.||||||
2573791|NCT02491411|Secondary|Changes in Quality of Life Assessment Scores, Assessed Using FACIT-Fatigue Scale and RANDSF-36 Surveys|Summary statistics of the scores will be reported at baseline before starting dexamethasone and each follow-up time during the treatment of dexamethasone and enzalutamide. Changes in quality of life scores over the course of the study will be computed and their significance will be evaluated by paired-sample t-tests.|Baseline to up to 4 weeks post-treatment|Data was not collected, the study was terminated early due to lower enrollment.||||||
2573792|NCT02491411|Primary|PSA Response Rate|PSA response rate is defined as the proportion of subjects with a >= 50% PSA decline from baseline level when starting enzalutamide and maintained for >= 4 weeks at any time-point after receiving enzalutamide. Will determine its corresponding 95% confidence interval.|Up to 4 weeks post-treatment|Data was not collected, the study was terminated early due to lower enrollment.||||||
2573793|NCT02491359|Secondary|Symptoms as Measured by Patient Self-report--Lee Chronic GVHD Symptom Scale|Lee symptom scale (LSS) has subscales with min=0, max=100; results given are 12mo scores, with higher numbers indicating higher symptom burden.|baseline|Only baseline surveys analyzed. Only 7 patients completed surveys at 6mo, not analyzed due to low number.|||units on a scale||Full Range|Median
2573796|NCT02491359|Secondary|Symptoms as Measured by Patient Self-report--Short Form-36 (SF-36)|SF-36 subscales have min=0 and max=100; results given are actual scores at 12mo, with higher scores indicating higher quality of life.|baseline|Only baseline surveys analyzed. Only 7 patients completed surveys at 6mo, not analyzed due to low number.|||units on a scale||Full Range|Median
2573800|NCT02491359|Secondary|Overall Response Rate|Overall response rate (ORR) (complete response + partial response) at 6 months will be determined by both clinician-defined categories of complete response and partial response, as well as separately calculated according to the proposed response definitions of the NIH Consensus Conference.|6 months||||participants|||Number
2573801|NCT02491359|Secondary|Incidence of Discontinuation of All Systemic Immune-suppressive Therapies|The incidence of complete discontinuation of all systemic immune-suppressive therapies will be determined at 1 year.|1 year||||Participants|||Count of Participants
2573802|NCT02491359|Secondary|Impact of Proteasome Inhibition|The biologic impact of proteasome inhibition in the treatment of chronic GVHD will be assessed at baseline, 3 and 6 months. The association between biologic outcome measures and clinical parameters (response, treatment failure, mortality) will be studied.|Up to 6 months|Data were not collected because biologic studies were not performed. Response to study drug too minimal to justify time and expense.||||||
2573803|NCT02491359|Secondary|Probability of Failure-free Survival at 1 Year|Kaplain-Meier estimate assessed at 1 year for failure-free survival, defined as absence of death from any cause, relapse, or addition of secondary immune-suppressive agents.|1 year||||probability of failure-free survival|||Number
2573804|NCT02491359|Secondary|Cumulative Incidence of Non-relapse Mortality and Primary Malignancy Relapse|The cumulative incidence of non-relapse mortality (defined as death in the absence of primary malignancy relapse after transplant) and relapse (defined as hematologic relapse or any unplanned intervention to prevent progression of disease in patients with evidence (molecular, cytogenetic, flow cytometric, radiographic) of malignant disease after transplantation) will be estimated from time of study therapy initiation. These will be treated as competing-risk events, and estimated at 1 year.|1 year||||Participants|||Count of Participants
2573805|NCT02491359|Secondary|Complete Response Rate|Complete response (CR) at 6 months will be determined by both clinician-defined CR, as well as separately calculated according to the proposed response definitions of the NIH Consensus Conference.|Up to 6 months|Participants who could be evaluated for response (not missing data)|||participants|||Number
2573806|NCT02491359|Primary|Probability of Treatment Failure at 6mo|Kaplan-Meier estimate assessed at 6 months for treatment failure, defined as requirement of an additional line of systemic immune-suppressive therapy, recurrent malignancy, or death.|6 months||||probability of treatment failure|||Number
2573807|NCT02491359|Primary|Incidence of Adverse Events|according to National Cancer Institute CTCAE, version 4.03|Up to 30 days following completion of study treatment||||participants|||Number
2573808|NCT02491073|Secondary|Comparison of Concentrations of TSH,as Measured in Non-ESL-exposed Subject Samples, With or Without the in Vitro Addition of Eslicarbazepine and (R)-Licarbazepine.||1 day|Safety Population: The safety population consisted of all subjects who were enrolled in the study, did not test positive for serum pregnancy (female subjects of childbearing potential only) or TPO antibodies, and provided valid serum samples for evaluating the thyroid hormone assays|||mU/L||Geometric Coefficient of Variation|Geometric Mean
2573809|NCT02491073|Secondary|Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) in Spiked and Unspiked Volunteer Samples Using ED and Automated Kit Assay.||1 day|Safety Population: The safety population consisted of all subjects who were enrolled in the study, did not test positive for serum pregnancy (female subjects of childbearing potential only) or TPO antibodies, and provided valid serum samples for evaluating the thyroid hormone assays|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2573810|NCT02491073|Secondary|Comparison of Concentrations of TT4, and TT3 as Measured in Non-ESL-exposed Subject Samples, With or Without the in Vitro Addition of Eslicarbazepine and (R)-Licarbazepine.||1 day|Safety Population: The safety population consisted of all subjects who were enrolled in the study, did not test positive for serum pregnancy (female subjects of childbearing potential only) or TPO antibodies, and provided valid serum samples for evaluating the thyroid hormone assays|||nmo/L||Geometric Coefficient of Variation|Geometric Mean
2573811|NCT02491073|Primary|Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) as Measured by Automated Kit Assay in Non-ESL Exposed Subjects, With and Without the in Vitro Addition of Eslicarbazepine and (R)-Licarbazepine.||1 day|Safety Population: The safety population consisted of all subjects who were enrolled in the study, did not test positive for serum pregnancy (female subjects of childbearing potential only) or TPO antibodies, and provided valid serum samples for evaluating the thyroid hormone assays|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2573812|NCT02491073|Primary|Comparison of Concentrations of Free Thyroid Hormones (FT4 and FT3) as Measured by ED and Automated Kit Assay Method in ESL-exposed Subjects||1 day|Safety Population: The safety population consisted of all subjects who were enrolled in the study, did not test positive for serum pregnancy (female subjects of childbearing potential only) or TPO antibodies, and provided valid serum samples for evaluating the thyroid hormone assays|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2573813|NCT02490670|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin Following a Single Dose||Predose,0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each period|All randomized participants who received at least one dose of study drug.|||Microgram per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2573814|NCT02490670|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Cephalexin Following a Single Dose||Predose, 0.167, 0.333, 0.5, 0.75, 1, 1.25, 1.500, 2, 2.5, 3, 3.5, 4, 5, 6, and 7 hours after drug administration in each period|All randomized participants who received at least one dose of study drug.|||hour*microgram per milliliter (h*μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2573815|NCT02490631|Secondary|Number of Participants With Positive or Abnormal Skin Cultures on Day of Surgery, Day of Discharge, 30 Days Post-op|Skin swabs collected on Day of Surgery, Day of Discharge, 30 days post-op|Day of Surgery, Day of Discharge, 30 days post-op||||Participants|||Count of Participants
2573816|NCT02490631|Primary|Surgical Site Infection Development at 30 Days Post-operative|Evaluation daily using the CDC guidelines, daily measurements and deidentified photos|post op day 30||||Participants|||Count of Participants
2574396|NCT02482870|Secondary|Airway Complications|Any complication related to the laryngoscopy and intubation, such as cut, bleeding, damage to the teeth, laryngospasm, bronchospasm, desaturation below 90%, is recorded.|The participants' will be followed for the duration of hospital stay, an expected average of 2 days||||participants|||Number
2573817|NCT02490475|Secondary|Number of Participants With DLTs|DLTs were defined as any of the following: 1) Any non-hematological toxicity greter than or equal to (≥) Grade 3 according t0 CTCAE version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management, 2) Grade 4 neutropenia lasting greater than (>) 7 days, 3) Febrile neutropenia, 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion or 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds.|From Baseline until 4 weeks after the end of treatment|Safety Population|||number of participants|||Number
2573818|NCT02490475|Secondary|CL for Docetaxel Alone and in Combination With Pertuzumab|Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per hour per meter squared (mL/h/m^2). The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.|||mL/h/m^2||Standard Deviation|Mean
2573819|NCT02490475|Secondary|Vss for Docetaxel Alone and in Combination With Pertuzumab|The volume of distribution at steady state (Vss), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.|||mL/m^2||Standard Deviation|Mean
2573820|NCT02490475|Secondary|AUC(0-∞) for Docetaxel Alone and in Combination With Pertuzumab|The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as ng*h/mL. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.|||ng*h/mL||Standard Deviation|Mean
2573821|NCT02490475|Secondary|Cmax for Docetaxel Alone and in Combination With Pertuzumab|Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose and is measures as nanograms per milliliter (ng/mL). The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1.|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.|||ng/mL||Standard Deviation|Mean
2573822|NCT02490475|Secondary|Tmax for Docetaxel Alone and in Combination With Pertuzumab|"Tmax is defined as the time after administration of a drug when the maximum plasma concentration is reached; Data for docetaxel alone arms were analyzed for the timepoints on Day 1 prior to the administration of pertuzumab. When the rate of absorption equals the rate of elimination. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1."|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.|||days||Full Range|Median
2573823|NCT02490475|Secondary|t1/2 for Docetaxel Alone and in Combination With Pertuzumab|"The biological half-life or terminal half-life of docetaxel is the time in hours it takes for it to lose half of its pharmacologic activity. Data for docetaxel alone arms were analyzed for the timepoints on Day 1 prior to the administration of pertuzumab. The pharmacokinetic parameters were derived by non-compartmental methods using WinNonLin version 5.0.1."|Cycles 1 and 2: Pre-dose, 30 and 55 minutes during dosing, 15 minutes, 30 minutes, 1, 2, 4, 8, and 23 hours Post-dose|ITT population; Data from Cohort 2 (docetaxel 75 mg/m^2 and pertuzumab 1050 mg) were excluded because there were only 2 participant data. It was planned not to report PK data, if less than or equal to 2 participants were analyzed. n= number of participants analyzed at the specified cycle.|||days||Full Range|Median
2573824|NCT02490475|Secondary|Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) by Category of Decrease and Timepoint|Ejection fraction (EF) is the fraction of outbound blood pumped from the heart with each heartbeat. It is commonly measured by echocardiogram and serves as a general measure of a person's cardiac function. Changes in LVEF were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 criteria. The decrease in LVEF has been categorized as follows: A) Increase, no change, decrease from baseline less than (<) 10%; B) Absolute value <50% and decrease from baseline greater than or equal to (≥) 10%; C) Absolute value <50% and decrease from baseline≥15% ; D) Other. If participants withdrew due to insufficient therapeutic response or death and had no tumor measurements at the final visit, they were counted under progressive disease for final visit.|Baseline, Weeks 7(Cycle 2), 13 (Cycle 4) and Final Visit Up to Week 22|ITT population; n = number of participants still receiving treatment at the specified cycle for each arm, respectively.|||percentage of participants|||Number
2573973|NCT02487771|Other Pre-specified|Heart Rate|Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|6 years|Missing data due to attrition, missed appointments or refusals|||Beats per minute (BPM)||Standard Deviation|Mean
2573825|NCT02490475|Secondary|Percentage of Participants by Best Overall Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Best Overall response was evaluated as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). CR: complete disappearance of all target lesions. PR: at least a 30 percent (%) decrease in the sum of the longest diameters. SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameters since the treatment started. PD: at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters of the target lesions recorded since the treatment started, including screening, or the appearance of one or more new lesions. If participants withdrew due to insufficient therapeutic response or death and had no tumor measurements at the final visit, they were counted under progressive disease for final visit.|Weeks 7 (Cycle 2),13 (Cycle 4) and Final Visit Up to 22 weeks|ITT population; n = number of participants still receiving treatment at the specified cycle for each arm respectively.|||percentage of participants|||Number
2573826|NCT02490475|Secondary|Mean Residence Time (MRT) of Pertuzumab|MRT is the average time that pertuzumab is present in the systemic circulation and is measured in days.|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.~n = number of participants analyzed at the specified timepoint for each arm, respectively."|||days||Standard Deviation|Mean
2573827|NCT02490475|Secondary|Volume of Distribution (Vz) at Steady State of Pertuzumab in Combination With Docetaxel|The volume of distribution at steady state (Vz), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma.|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.~n = number of participants analyzed at the specified timepoint for each arm, respectively."|||mL||Standard Deviation|Mean
2573828|NCT02490475|Secondary|Clearance (Cl) of Pertuzimab in Combination With Docetaxel|Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per day (mL/day).|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.~n = number of participants analyzed at the specified timepoint for each arm, respectively."|||mL/day||Standard Deviation|Mean
2573829|NCT02490475|Secondary|AUC From Time Zero to Infinity (AUC [0-infinity]) for Pertuzumab in Combination With Docetaxel|The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as μg*day/mL.|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.~n = number of participants analyzed at the specified timepoint for each arm, respectively."|||μg*day/mL||Standard Deviation|Mean
2573830|NCT02490475|Secondary|Area Under the Concentration Curve From Time Zero to the Last Visit (AUC [0-last]) for Pertuzumab in Combination With Docetaxel|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-last is calculated from time 0 (prior to administration of medication) to last measured data point. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as micrograms times days per milliliter (μg*day/mL).|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|"ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis.~n = number of participants analyzed at the specified timepoint for each arm, respectively."|||μg*day/mL||Standard Deviation|Mean
2573831|NCT02490475|Secondary|Maximum Observed Plasma Concentration (Cmax) for Pertuzumab in Combination With Docetaxel|Cmax refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and prior to the administration of a second dose and is measures as micrograms per milliliter (μg/mL).|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis. n = number of participants analyzed at the specified timepoint for each arm, respectively.|||μg/mL||Standard Deviation|Mean
2573832|NCT02490475|Secondary|Plasma Decay Half Life (t1/2) for Pertuzumab in Combination With Docetaxel|The biological half-life or terminal half-life of pertuzumab is the time in days it takes for it to lose half of its pharmacologic activity.|Cycle1: Day 2 Pre-dose and 15 minutes, 1.5, 4 and 8 hours Post-dose, and Days 3, 6, 9 and 16; Cycle 2: Day 1 Pre-dose and 15 minutes Post-dose on Days 1, 8, 15 and 22|ITT population; Participants in any cohort infused with the specified dose of pertuzumab were included in analysis. number (n) equals (=) number of participants analyzed at the specified timepoint for each arm, respectively.|||days||Full Range|Median
2573845|NCT02489799|Secondary|Prevalence of Participants Who Acknowledge Having a Conversation With Their Surrogate Decision Maker Regarding Advance Care Planning Across Study Arms Throughout the Study Period|This tracks which participants report having had an advance care planning-related conversation with their surrogate decision maker.|Enrollment, one month after surgery|This question was only asked to participants who reported having designated a medical decision maker.|||Participants|||Count of Participants
2573974|NCT02487771|Other Pre-specified|Heart Rate|Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|5.5 years|Missing data due to attrition, missed appointments or refusals|||Beats per minute (BPM)||Standard Deviation|Mean
2573833|NCT02490475|Primary|Maximum Tolerated Dose (MTD) of Docetaxel in Combination of Pertuzumab|A prior dose level was defined as an MTD if at a certain dose level, there were greater than or equal to (≥) 2 out of 6 participants who had Dose Limiting Toxicities (DLTs). If there were no DLTs or DLTs were seen in less than (<) 2 participants in the highest dose level, that was considered as MTD. Participants received escalating doses of docetaxel and pertuzumab until DLTs were observed. DLTs were defined as any of the following: 1) Any non-hematological toxicity ≥ Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 except for fever, chills and flu-like symptoms, in spite of adequate toxicity management, 2) Grade 4 neutropenia lasting greater than (>) 7 days, 3) Febrile neutropenia, 4) Thrombocytopenia Grade 4 or any thrombocytopenia requiring platelet transfusion or 5) Any subjectively intolerable toxicity felt by the investigator to be related to either one of the compounds.|Cycle 1 Up to Day 15|Safety Population: included all participants who received any amount of study medication and who had at least one post-baseline safety follow-up.|||mg/m^2|||Number
2573834|NCT02490371|Secondary|Change of Health Status Measurement From Baseline to at 4th Weeks and at 12th Weeks in Stroke Impact Scale|The 59-item Stroke Impact Scale (SIS) is a stroke-specific, self-report, health status measure. Total range from 0 to 100. Higher score reflect better result.|Baseline and at 4th & 12 th weeks||||score on a scale||Standard Deviation|Mean
2573835|NCT02490371|Secondary|Change of Reaction Time From Baseline to at 4th Weeks and at 12th Weeks Training in Time Measurement (Seconds)|A simple reaction time will be recorded through a computer system. Time for the patient to reaction to the signal will be measured in seconds (sec). Shorter period of time reflect better reaction time.Lower score means better result|Baseline and at 4th weeks and at 12th weeks||||seconds||Standard Deviation|Mean
2573836|NCT02490371|Secondary|Change of Upper Limb Function From Baseline to at 4th Weeks Training in Action Research Arm Test (ARAT) Scale|The 19-item Action Research Arm Test has four subscales that assess various aspects of upper limb function (i.e., pinch, grip, grasp, and gross motor). Each item was rated on a 4-point scale from 0 to 3. Scale from 0 to 57.A higher score was indicative of better upper limb function.|Baseline and at 4th weeks and at 12th weeks||||units on a scale||Standard Deviation|Mean
2573837|NCT02490371|Secondary|Change of Grip Strength From Baseline to at 4th Weeks and at 12th Weeks Training in Force (Kilogram )|Isometric hand grip strength will be measured using the hand-held dynamometer in kilogram (kg). Higher value reflect better hand grip strength|Baseline and at 4th weeks and at 12th weeks||||kilgograms||Standard Deviation|Mean
2573838|NCT02490371|Secondary|Change of Upper Limb Impairment From Baseline to at 4th Weeks & 12 th Weeks Training in Fugl-Meyer Assessment (FM) Scale|"Fugl-Meyer Assessment (FM) scale is a stroke-specific, performance-based impairment index, the scale range from 0 to 66.~25 test items included measurement of movement, coordination, and reflex action of the different parts of the paretic upper extremity. The score could range from 0 to 66. Better motor function was reflected by a higher FMA score"|Baseline and at 4th weeks and at 12th weeks||||score on a scale||Standard Deviation|Mean
2573839|NCT02490371|Primary|Change of Cortical Excitability From Baseline to at 4th Weeksand 12th Weeks Training in Motor Evoked Potential at 120% Resting MotorThreshold at Affected Hand|Electromyographic (EMG) activity in first doral interossei measured at 120% resting motor threshold. The motor evoked potential amplitude will be measured peak to peak in millivolt(mV). Higher value mean better control|Baseline and at 4th weeks and at 12th weeks||||millivolt||Standard Deviation|Mean
2573840|NCT02490293|Secondary|Duration of Hospitalization|the duration between the operation day and the day of discharge|participants will be followed for the duration of hospital stay, an expected average of 2 days||||days||Standard Deviation|Mean
2573841|NCT02490293|Primary|Number of Participants With Infectious Postoperative Complications|Incidence of infectious postoperative complications in patients who underwent a laparoscopic cholecystectomy due to grade I Tokyo guidelines for acute cholecystitis or grade II Tokyo guidelines for acute cholecystitis except the evidence of gallbladder perforation, with antibiotics or placebo|30 days||||Participants|||Count of Participants
2573842|NCT02489981|Secondary|Change From Baseline in Asthma Control Status at Week 52|"The effectiveness was determined based on the change of asthma control status from baseline at Week 52 which is the secondary endpoint in the surveillance. The asthma control status was rated on a 3-point scale of well controlled, insufficiently controlled and poorly controlled based on asthma symptoms (in the daytime or at night), use of reliever and limitation of activities including exercise (based on Asthma prevention and management guideline).~Well-controlled=WC, Insufficiently-controlled=IC, Poorly-controlled=PC, Unknown=Unk, Missing=Miss, Baseline=BL, Week 52=W52"|Baseline and Week 52|Efficacy set: This patient set is a subset of the safety set that includes all patients in the safety set who have baseline and at least one available on-treatment asthma control status, Peak Expiratory Flow Rate (PEFR), Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC) or Asthma Control Questionnaire (ACQ) 6 score.|||Percentage of participants|||Number
2573843|NCT02489981|Primary|Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)|Percentage of patients with ADRs are presented. There was no primary outcome for effectiveness as the primary objective of the surveillance is the evaluation of safety.|Week 52|Safety set: This patient set includes all patients who were documented to have taken at least one dose of Spiriva Respimat except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact.|||Percentage of participants|||Number
2573844|NCT02489968|Primary|Change in Glycated Haemoglobin A1c (HbA1c) (%) From Baseline After 24 Weeks of Treatment|Change from baseline in HbA1c (%) after 24 weeks of treatment with double-blind trial medication. Change was calculated as: HbA1c value at 24-week - HbA1c value at baseline, for each patient. Baseline was defined as the last observation before the first intake of double-blind randomised trial medication. Statistical analysis presented is based on a restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach. Full Analysis Set (Observed Cases) [FAS (OC)]: This analysis set consisted of all patients who were randomised and treated with at least 1 dose of trial drug during the double-blind part of the trial and who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the 24-week double-blind part of the trial. Observed cases analysis included only the available data that were observed while patients were on treatment, i.e., excluding the missing data.|Baseline and 24 week|FAS (OC)|||Percentage (%)||Standard Error|Least Squares Mean
2573846|NCT02489799|Secondary|Prevalence of Participants Who Acknowledge Having Named a Surrogate Decision Maker Across Study Arms Throughout the Study Period|This tracks which participants report having named a surrogate decision maker|Enrollment, one month after surgery|At each milestone of data collection, a number of participants were unable to complete the HADS questionnaire due to one of a number of factors including complicated medical course, attrition, or loss of eligibility.|||Participants|||Count of Participants
2573847|NCT02489799|Secondary|Patient and Provider Satisfaction Scores Across Study Arms|The satisfaction score, as the sum of the scores of six questions (all in Likert scale), ranges from 6 to 30, with a higher score indicating higher level of satisfaction.|One week after enrollment|In two instances, the surgeon was unable to complete the satisfaction scale. This explains why there are fewer surgeon perceptions reported than patients.|||units on a scale||Standard Deviation|Mean
2573848|NCT02489799|Secondary|Recommendation of the Video to Others Across Study Arms|This Likert scale evaluates respondent beliefs about whether they would recommend the video to others.|One week after enrollment||||Participants|||Count of Participants
2573849|NCT02489799|Secondary|Comfort With the Video Across Study Arms|This Likert scale evaluates respondent beliefs about their comfort in viewing the video.|One week after enrollment||||Participants|||Count of Participants
2573850|NCT02489799|Secondary|Helpfulness of the Video Across Study Arms|This Likert scale evaluates respondent beliefs about the helpfulness of the video.|One week after enrollment||||Participants|||Count of Participants
2573851|NCT02489799|Secondary|Iowa Goals of Care Across Study Arms Throughout the Study Period|"This metric enables respondents to verify why they are seeking medical care. The most selected goal at all visits was Cure my medical condition. We have reported the number of participants in each group who selected this goal at each time point."|Enrollment, one week after enrollment, one week after surgery, one month after surgery|At each milestone of data collection, a number of participants were unable to complete the Iowa Goals of Care questionnaire due to one of a number of factors including complicated medical course, attrition, or loss of eligibility.|||Participants|||Count of Participants
2573852|NCT02489799|Secondary|Hospital Anxiety and Depression Scores Across Study Arms Throughout the Study Period|This validated metric consists of two sub scales: one for symptoms of anxiety, and the other for symptoms of depression. Each subscale, consisting of seven questions, results in a score ranging from 0, indicating no distress, to 21, indicating maximum distress; a score higher than 7 indicates clinically meaningful anxiety or depression. Overall HADS scores, encompassing both subscales, results in a total score of 0 (no mood symptoms ) to 42 (maximal mood symptoms).|Enrollment, one week after enrollment, one week after surgery, one month after surgery|At each milestone of data collection, a number of participants were unable to complete the HADS questionnaire due to one of a number of factors including complicated medical course, attrition, or loss of eligibility.|||units on a scale||Standard Deviation|Mean
2573853|NCT02489799|Primary|Measured Patient Centeredness in the Presurgical Consent Visit|The RIAS scoring system using an audio-recording of a conversation to evaluate the nature of the conversation between surgeon and patient. The patient-centeredness summary score is a ratio of statements that reflect the psychosocial and socio-emotional elements of exchange about the lived illness experience of patients relative to statements that reflect a more biomedical and disease focused perspective. This score reflects the encounter as a whole, rather than an individual's dialogue. A value greater than one indicates a more patient-centered encounter; whereas, a value less than one indicates a more biomedical encounter.|Approximately one week after study enrollment.|Audio recordings of a presurgical consent visit conversation between a surgeon and patient.|||Patient Centeredness Score|Audio Recordings|Standard Deviation|Mean
2573854|NCT02489799|Primary|Measured ACP Content in the Presurgical Consent Visit|The RIAS scoring system using an audio-recording of a conversation to evaluate conversation content.|Approximately one week after study enrollment.|Of note, the sample size is smaller for this outcome as our study did not collect recordings for all participants enrolled at the baseline visit. The reasons we did not collect the recordings include scheduling of emergent surgery without time to record, human and technology error, and patient preference.|||Recordings|Recordings||Count of Units
2573855|NCT02489773|Secondary|Kendall Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval MBG in the First 3 Months in Group 1|Comparing the Kendall correlation of changes in GA and MBG to the Kendall correlation of changes in HbA1c and MBG, from baseline to any matching post-baseline visit in the first 3 months in Group 1.|From baseline to the first 3 months after enrollment in Group 1|It is pre-specified to collect and report data for only participants who had a change in treatment (Group 1)|||kendall correaltion coefficient|||Number
2573856|NCT02489773|Secondary|Spearman Correlation Analysis of Changes in GA, HbA1c, and 7-day Interval Mean Blood Glucaose (MBG) in the First 3 Months in Group 1|Comparing the Spearman correlation of changes in GA and MBG to the Spearman correlation of changes in HbA1c and MBG, from baseline to any matching post-baseline visit in the first 3 months in Group 1.|From baseline to the first 3 months after enrollment in Group 1|It is pre-specified to collect and report data for only participants who had a change in treatment (Group 1).|||spearman correlation coefficient|||Number
2573857|NCT02489773|Primary|Compare the Pearson Correlation of Glycated Albumin (GA) and Fructosamine Within All Subjects With the Performance Goal of 0.8||From baseline to 6 months||||Pearson correlation coefficient|||Number
2573858|NCT02489500|Secondary|Number of Participants With Organ Response|analysis of number of patients with organ response, as defined on page 13 of the detailed protocol for kidney, heart and liver.|5 years|Due to early termination, organ response data was not collected.||||||
2573859|NCT02489500|Secondary|Overall Survival|duration of overall survival measured in days|5 years|The protocol was closed prior to the 5-year period of assessment, so 5-year survival assessment of only two participants was assessed.|||days|||Number
2573860|NCT02489500|Secondary|Toxicities|Number of serious adverse events per participant based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|100 days||||events per participant||Full Range|Mean
2573861|NCT02489500|Primary|Number of Participants With Hematologic Response|Hematologic response defined as: at least 50% improvement in the difference between involved and uninvolved free light chains|6 months|Two participants were not evaluable as they expired and did not have a post-treatment response evaluation.|||Participants|||Count of Participants
2573865|NCT02489344|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Weeks 26, 52, 104, and 156|Estimated glomerular filtration rate was used to measure level of kidney function and determine the stage of kidney disease. Change from baseline in eGFR was obtained by subtracting baseline value from post-baseline value at Weeks 26, 52, 104 and 156. For this analysis, baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||mL/min/1.73m^2||Standard Deviation|Mean
2573866|NCT02489344|Secondary|Number of Participants in Categories of Brain Magnetic Resonance Imaging (MRI) Results at Baseline and Weeks 26, and 156|All continuous MRI variables were summarized using descriptive statistics for each visit. The overall interpretation of the readings were summarized in 2 categories as: normal, and abnormal. For this analysis, baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 26, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||Participants|||Count of Participants
2573867|NCT02489344|Secondary|Number of Participants in Categories of Echocardiogram (ECHO) Results at Baseline and at Weeks 26, 52, 104, and 156|The summary statistics of all continuous echocardiogram variables were calculated for each visit. The overall interpretation of the readings were summarized in 3 categories: normal, abnormal but not clinically significant (NCS), and abnormal but clinically significant (CS) categories. For this analysis, baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||Participants|||Count of Participants
2573868|NCT02489344|Secondary|Change From Baseline in Albumin/Creatinine Ratio (ACR) and Protein/Creatinine Ratio (PCR) at Weeks 26, 52, 104, and 156|For each scheduled visit for this assessment, 3 timed overnight urine samples were collected between 4 to 7 days of each other. All urine samples were collected within a 16-day period. ACR and PCR were determined for each collection. The median of the values determined for the 3 collections/visit was used for analysis. Baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||mg/g||Standard Deviation|Mean
2573869|NCT02489344|Secondary|Change From Baseline in Beck Depression Inventory (BDI) Total Score at Weeks 26, 104, and 156|The BDI-II Scale was a 21-item scoring tool which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. Each symptoms were scored on a 4-point scale of 0 to 3 (0=symptom not present); (3=symptom very intense). Scores for each symptom were added up to obtain the total scores for all 21 items, which were interpreted as follows: Scores of 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression and 29-63: severe depression, where higher scores indicated more depression. For this analysis, baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 26, 104, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||score on a scale||Standard Deviation|Mean
2573870|NCT02489344|Secondary|Gastrointestinal Symptoms: Number of Participants With Stool Consistency Assessment by Bristol Stool Scale Scoring at Baseline and Weeks 26, 52, 104, and 156|"Participants were asked to rate their stool consistency in past 10 days (before each of the specified time points) on a 7-point Bristol stool scale, according to the following types: 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces. Types 1 and 2 indicate constipation, types 3 and 4 indicate ideal stools (easiest to defecate), and 5-7 tending towards diarrhea. Frequency of each stool type was categorized as 'never', occasionally', or 'often'. For this analysis, baseline was defined as the initial ACT13739 study baseline."|Baseline of ACT13739 study and Weeks 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on Full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||Participants|||Count of Participants
2573871|NCT02489344|Secondary|Gastrointestinal Symptoms: Influence of GI Symptoms of Fabry Disease on Life at Baseline and Weeks 2, 4, 8, 12, 18, 26, 52, 104, and 156|Participants assessed their GI symptoms (abdominal pain, abdominal distention, bowel movements) by completing a questionnaire (modified version of the inflammatory bowel severity scoring system). Participants were asked to mark the influence of their GI symptoms of Fabry disease on life in past 10 days (before each of the specified time points) on a VAS. The scale ranged from 0% (no at all) to 100% (completely), where higher percentage indicated more influence of the GI symptoms of the disease on life. For this analysis, baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 2, 4, 8, 12, 18, 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on Full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||score on a 0-100 percent scale||Standard Deviation|Mean
2573975|NCT02487771|Other Pre-specified|Heart Rate|Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|5 years|Missing data due to attrition, missed appointments or refusals|||Beats per minute (BPM)||Standard Deviation|Mean
2573872|NCT02489344|Secondary|Gastrointestinal Symptoms: Frequency of Bowel Movements - Least Number of Times Bowel Movement Per Day at Baseline and Weeks 2, 4, 8, 12, 18, 26, 52, 104, and 156|"Participants assessed their GI symptoms (abdominal pain, abdominal distention, bowel movements) by completing a questionnaire (modified version of the inflammatory bowel severity scoring system). Participants were asked to report the frequency of their bowel movement (per day or per week or per month) in past 10 days (before each of the specified time points). Participants answered the question What is the least number of times you move your bowels per day/week/month?. Participants selected their preferred time unit (e.g., per day). Response provided by participants was converted to number of times per day for reporting the results. For this analysis, baseline was defined as initial ACT13739 study baseline."|Baseline of ACT13739 study and Weeks 2, 4, 8, 12, 18, 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||number of bowel movements per day||Standard Deviation|Mean
2573873|NCT02489344|Secondary|Gastrointestinal Symptoms: Frequency of Bowel Movements - Most Number of Times Bowel Movement Per Day at Baseline and Weeks 2, 4, 8, 12, 18, 26, 52, 104, and 156|"Participants assessed their GI symptoms (abdominal pain, abdominal distention, bowel movements) by completing a questionnaire (modified version of the inflammatory bowel severity scoring system). Participants were asked to report the frequency of their bowel movement (per day or per week or per month) in past 10 days (before each of the specified time points) by answering the question What is the most number of times you move your bowels per day/week/month?. Participants selected their preferred time unit (e.g., per day). Response provided by participants was converted to number of times per day for reporting the results. For this analysis, baseline was defined as initial ACT13739 study baseline."|Baseline of ACT13739 study and Weeks 2, 4, 8, 12, 18, 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||number of bowel movements per day||Standard Deviation|Mean
2573874|NCT02489344|Secondary|Gastrointestinal Symptoms: Satisfaction Over Bowel Habits at Baseline and Weeks 2, 4, 8, 12, 18, 26, 52, 104, and 156|Participants assessed their GI symptoms (abdominal pain, abdominal distention, bowel movements) by completing a questionnaire (modified version of the inflammatory bowel severity scoring system). Participants were asked to mark their satisfaction over bowel habits in past 10 days (before each of the specified time points) on a VAS. The scale ranged from 0% (very happy) to 100% (very unhappy), where higher percentage indicated less satisfaction. For this analysis, baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 2, 4, 8, 12, 18, 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||score on a 0-100 percent scale||Standard Deviation|Mean
2573875|NCT02489344|Secondary|Gastrointestinal Symptoms: Number of Participants in Categories of Response Regarding Eating Less Due to Abdominal Pain/Bloating at Baseline and Weeks 2, 4, 8, 12, 18, 26, 52, 104, and 156|"Participants assessed their GI symptoms (abdominal pain, abdominal distention, bowel movements) by completing a questionnaire (modified version of the inflammatory bowel severity scoring system). Participants responded to question How often do you eat less during meals due to abdominal pain and/or bloating? in past 10 days (before each of the specified time points) in the categories as 'never', 'occasionally' or 'often'. For this analysis, baseline was defined as initial ACT13739 study baseline."|Baseline of ACT13739 study and Weeks 2, 4, 8, 12, 18, 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||Participants|||Count of Participants
2573876|NCT02489344|Secondary|Gastrointestinal Symptoms: Abdominal Distension Severity Score at Baseline and Weeks 2, 4, 8, 12, 18, 26, and 156|Participants assessed their GI symptoms (abdominal pain, abdominal distention, bowel movements) by completing a questionnaire (modified version of the inflammatory bowel severity scoring system). Participants were asked to mark the severity of the abdominal distension in past 10 days (before each of the specified time points) on a VAS. The scale ranged from 0% (no distention) to 100% (very severe), where higher score indicated more severity. For this analysis, baseline was defined as initial ACT13739 study baseline. The SD can only be calculated when there are more than 1 participant with data available. Thereby, applicable fields were left blank when SD was not calculable.|Baseline of ACT13739 study and Weeks 2, 4, 8, 12, 18, 26, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||score on a 0-100 percent scale||Standard Deviation|Mean
2573877|NCT02489344|Secondary|Gastrointestinal Symptoms: Number of Participants With Abdominal Distension at Baseline and Weeks 2, 4, 8, 12, 18, 26, 52, 104, and 156|"Participants assessed their GI symptoms (abdominal pain, abdominal distention, bowel movements) by completing a questionnaire (modified version of the inflammatory bowel severity scoring system). Participants were asked to report the presence of abdominal distention in past 10 days (before each of the specified time points). Participants answered the question: Do you currently suffer from abdominal distension (bloating, swelling or tight tummy)? [Yes/No]. For this analysis, baseline was defined as initial ACT13739 study baseline."|Baseline of ACT13739 study and Weeks 2, 4, 8, 12, 18, 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||Participants|||Count of Participants
2574416|NCT02482675|Primary|Vascular Endothelial Function|Flow mediated dilation (FMD) of the brachial artery, calculated as FMD AUC for 0-180 minutes (change from baseline)|Area under curve for FMD for three hours (0, 30, 60, 90, 120, 180 minutes)||||%*min||Standard Error|Mean
2573878|NCT02489344|Secondary|Gastrointestinal Symptoms: Number of Days With Abdominal Pain Score at Baseline and Weeks 2, 4, 8, 12, 18, 26, 52, 104, and 156|Participants assessed their GI symptoms (abdominal pain, abdominal distention, bowel movements) by completing a questionnaire (modified version of the inflammatory bowel severity scoring system). Participants were asked to report the number of days they had abdominal pain in past 10 days (before each of the specified time points). Number of days with abdominal pain score was achieved by multiplying number of days with pain * 10. The score ranges from 10 to 100, where higher score signifies more number of days with pain. For this analysis, baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 2, 4, 8, 12, 18, 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||score on a scale||Standard Deviation|Mean
2573879|NCT02489344|Secondary|Gastrointestinal Symptoms: Abdominal Pain Severity Score at Baseline and Weeks 2, 4, 8, 12, 18, 26, 52, 104, and 156|Participants assessed their GI symptoms (abdominal pain, abdominal distention, bowel movements) by completing a questionnaire (modified version of the inflammatory bowel severity scoring system). Participants were asked to mark the severity of the abdominal pain in past 10 days (before each of the specified time points) on a visual analogue scale (VAS). The scale ranged from 0% (no pain) to 100% (very severe), where higher score indicated more severity. For this analysis, baseline was defined as initial ACT13739 study baseline. Standard deviation (SD) can only be calculated when there are more than 1 participant with data available. Thereby, applicable fields were left blank when SD was not calculable.|Baseline of ACT13739 study and Weeks 2, 4, 8, 12, 18, 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||score on a 0-100 percent scale||Standard Deviation|Mean
2573880|NCT02489344|Secondary|Gastrointestinal (GI) Symptoms: Number of Participants With Abdominal Pain at Baseline and Weeks 2, 4, 8, 12, 18, 26, 52, 104, and 156|"Participants assessed their GI symptoms (abdominal pain, abdominal distention, bowel movements) by completing a questionnaire (modified version of the inflammatory bowel severity scoring system). Participants were asked to report the presence of abdominal pain in past 10 days (before each of the specified time points). Participants answered the question: Do you currently suffer from abdominal (tummy) pain? [Yes/No]. For this analysis, baseline was defined as initial ACT13739 study."|Baseline of ACT13739 study and Weeks 2, 4, 8, 12, 18, 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||Participants|||Count of Participants
2573881|NCT02489344|Secondary|Change From Baseline in Mental Component Summary and Physical Component Summary of the Short Form-36 (SF-36) Health Survey at Weeks 26, 52, 104 and 156|The SF-36 health survey is a participant-reported survey to measure participant's health. It is a 36-item questionnaire used to measure 8 various aspects of health (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health). The score range for each of the 8 aspects was from 0 (maximum disability) to 100 (no disability), higher scores indicating good health condition. Responses on the SF-36 were also used to calculate 2 summary scores: Physical component score (PCS) and mental component score (MCS). The score range for each of these 2 summary scores was from 0 (maximum disability) to 100 (no disability), where higher score indicated less disability or good health condition. For this analysis, baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||units on a scale||Standard Deviation|Mean
2573882|NCT02489344|Secondary|Summary of Shifts From Baseline in Skin GL-3 Score in Perineurium Cells Over Time: Number of Participants in Categories of Shift in GL-3 Score|Skin biopsies were performed for the scoring of GL-3 accumulation/inclusions by light microscopy. Three independent pathologists scored GL-3 clearance by using an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe), where higher score indicated more severe condition. A single score per participant per time point was derived by taking the score rated by a majority of the pathologists; if a majority score could not be derived, the median score was used. Data were summarized and reported in terms of number of participants with shift from baseline GL-3 score to Weeks 12, 26, 52, and 156 GL-3 score. Shift to lower score from baseline indicated less severe condition at that respective time point. Any shift category of Baseline score/Week score that was not observed (no participant had data in the category) was not reported. For this analysis, baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 12, 26, 52, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||Participants|||Count of Participants
2573889|NCT02489344|Secondary|Change From Baseline in Plasma Monosialodihexosylganglioside (GM3) Concentration At Weeks 26, 52, 104, and 156|Change from baseline in plasma GM3 was obtained by subtracting baseline value from post-baseline value at Weeks 26, 52, 104, and 156. Concentration of GM3 in plasma was determined using a validated LC-MS/MS method. For this analysis, baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||mcg/mL||Standard Deviation|Mean
2574678|NCT02478359|Other Pre-specified|Diastolic Blood Pressure|Average of all routine clinic blood pressure reading taken between 6 and 12-months post randomization. BP obtained with temperatures of >100F and those obtained in urgent care were excluded.|6-12 months following randomization|As-treated Walk On population|||mmHg||Standard Deviation|Mean
2573883|NCT02489344|Secondary|Summary of Shifts From Baseline in Skin GL-3 Score in Deep Vessels Smooth Muscle Cells Over Time: Number of Participants in Categories of Shift in GL-3 Score|Skin biopsies were performed for the scoring of GL-3 accumulation/inclusions by light microscopy. Three independent pathologists scored GL-3 clearance by using an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe), where higher score indicated more severe condition. A single score per participant per time point was derived by taking the score rated by a majority of the pathologists; if a majority score could not be derived, the median score was used. Data were summarized and reported in terms of number of participants with shift from baseline GL-3 score to Weeks 12, 26, 52, and 156 GL-3 score. Shift to lower score from baseline indicated less severe condition at that respective time point. Any shift category of Baseline score/Week score that was not observed (no participant had data in the category) was not reported. For this analysis, baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 12, 26, 52, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||Participants|||Count of Participants
2573884|NCT02489344|Secondary|Summary of Shifts From Baseline in Skin GL-3 Score in Deep Vessels Endothelial Cells Over Time: Number of Participants in Categories of Shift in GL-3 Score|Skin biopsies were performed for the scoring of GL-3 accumulation/inclusions by light microscopy. Three independent pathologists scored GL-3 clearance by using an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe), where higher score indicated more severe condition. A single score per participant per time point was derived by taking the score rated by a majority of the pathologists; if a majority score could not be derived, the median score was used. Data were summarized and reported in terms of number of participants with shift from baseline GL-3 score to Weeks 12, 26, 52, and 156 GL-3 score. Shift to lower score from baseline indicated less severe condition at that respective time point. Any shift category of Baseline score/Week score that was not observed (no participant had data in the category) was not reported. For this analysis, baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 12, 26, 52, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||Participants|||Count of Participants
2573885|NCT02489344|Secondary|Summary of Shifts From Baseline in Skin GL-3 Score in Superficial Capillary Endothelial Cells Over Time: Number of Participants in Categories of Shift in GL-3 Score|Skin biopsies were performed for the scoring of GL-3 accumulation/inclusions by light microscopy. Three independent pathologists scored GL-3 clearance by using an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe), where higher score indicated more severe condition. A single score per participant per time point was derived by taking the score rated by a majority of the pathologists; if a majority score could not be derived, the median score was used. Data were summarized and reported in terms of number of participants with shift from baseline GL-3 score to Weeks 12, 26, 52, and 156 GL-3 score. Shift to lower score from baseline indicated less severe condition at that respective time point. Any shift category of Baseline score/Week score that was not observed (no participant had data in the category) was not reported. For this analysis, baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 12, 26, 52, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||Participants|||Count of Participants
2573886|NCT02489344|Secondary|Change From Baseline in Podocyturia Counts (Per Milligram of Creatinine) At Weeks 12, 26, and 156|Change from baseline in podocyturia was obtained by subtracting baseline value from post-baseline value at Weeks 12, 26, and 156. Urine samples were processed to identify podocyte (podocalyxin, PCX) and parietal cell (claudin 1, CL1) markers. PCX +/CL1 negative cells were identified as podocytes and PCX +/CL1 positive cells as parietal cells with podocyte phenotype. All counts were corrected for urine Cr. For this analysis, baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 12, 26, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||Count of podocytes/mg Cr||Standard Deviation|Mean
2573887|NCT02489344|Secondary|Change From Baseline in High Sensitivity Cardiac Troponin T At Weeks 26, 52, 104, and 156|Change from baseline in high sensitivity cardiac troponin T was obtained by subtracting baseline value from post-baseline value at Weeks 26, 52, 104, and 156. For this analysis, baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||mcg/L||Standard Deviation|Mean
2573888|NCT02489344|Secondary|Change From Baseline in Urine GL-3 Concentration At Weeks 26, 52, 104, and 156|Change from baseline in urine GL-3 was obtained by subtracting baseline value from post-baseline value at Weeks 26, 52, 104, and 156. Concentration of GL-3 in urine was determined using a validated LC-MS/MS method. For this analysis, baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||mg/mmol creatinine (Cr)||Standard Deviation|Mean
2573976|NCT02487771|Other Pre-specified|Heart Rate|Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|4.5 years|Missing data due to attrition, missed appointments or refusals|||Beats per minute (BPM)||Standard Deviation|Mean
2573890|NCT02489344|Secondary|Change From Baseline in Plasma Glucosylceramide (GL-1) Concentration At Weeks 26, 52, 104, and 156|Change from baseline in plasma GL-1 was obtained by subtracting baseline value from post-baseline value at Weeks 26, 52, 104, and 156. Concentration of GL-1 in plasma was determined using a validated LC-MS/MS method. For this analysis, baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||mcg/mL||Standard Deviation|Mean
2573891|NCT02489344|Secondary|Change From Baseline in Plasma Lyso Globotriaosylceramide (Lyso GL-3) Concentration at Weeks 26, 52, 104, and 156|Change from baseline in plasma GL-3 was obtained by subtracting baseline value from post-baseline value at Weeks 26, 52, 104, and 156. Concentration of lyso-GL-3 in plasma was determined using a validated LC-MS/MS method. For this analysis, baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||nanograms per mL (ng/mL)||Standard Deviation|Mean
2573892|NCT02489344|Secondary|Change From Baseline in Plasma Globotriaosylceramide (GL-3) Concentration at Weeks 26, 52, 104, and 156|Change from baseline in plasma GL-3 was obtained by subtracting baseline value from post-baseline value at Weeks 26, 52, 104, and 156. Concentration of GL-3 in plasma was determined using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. For this analysis, baseline was defined as initial ACT13739 study baseline.|Baseline of ACT13739 study and Weeks 26, 52, 104, and 156 post-ACT13739 baseline|Analysis was performed on full analysis set: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis. Here, ‘number analyzed’ = participants with available data for each specified category.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
2573893|NCT02489344|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities|"Criteria for potentially clinically significant ECG abnormalities:~ECG mean HR: <30 bpm; <30 bpm and DFB >=20 bpm; <40 bpm; <40 bpm and DFB >=20 bpm; <50 bpm; <50 bpm and DFB >=20 bpm; >90 bpm; <90 bpm and DFB >=20 bpm; >100 bpm; <100 bpm and DFB >=20 bpm; >120 bpm; <120 bpm and DFB >=20 bpm~PR Interval: >200 milliseconds (ms); >200 ms and IFB >=25%; >220 ms; >220 ms and IFB >=25%; >240 ms; >240 ms and IFB >=25%~QRS duration: >110 ms; >110 ms and IFB >=25%; >120 ms; >120 ms and IFB >=25%~QTc Bazett (QTcB) interval: >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms, IFB >60 ms~QTc Fridericia (QTc F): >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms; IFB >60 ms~QT Interval: >500 ms For this analysis, baseline was defined as initial ACT13739 study baseline."|From baseline of ACT13739 study up to 37 months post-ACT13739 baseline|Analysis was performed on safety population: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis.|||Participants|||Count of Participants
2573894|NCT02489344|Primary|Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities|"Criteria for potentially clinically significant vital sign abnormalities:~Systolic blood pressure (SBP) supine: <=95 millimeters of mercury (mmHg) and DFB >=20 mmHg; >=160 mmHg and increase from baseline (IFB) >=20 mmHg~Diastolic blood pressure (DBP) supine: <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB >=10 mmHg~Heart rate (HR) supine: <=50 beats per minute (bpm) and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm~Weight: >=5% DFB; >=5% IFB For this analysis, baseline was defined as initial ACT13739 study baseline."|From baseline of ACT13739 study up to 37 months post-ACT13739 baseline|Analysis was performed on safety population: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis.|||Participants|||Count of Participants
2573895|NCT02489344|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Urinalysis|"Criteria with potentially clinically significant urine abnormalities:~pH: <= 4.6; pH: >= 8.0"|From baseline of ACT13739 study up to 37 months post-ACT13739 baseline|Analysis was performed on safety population: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis.|||Participants|||Count of Participants
2573896|NCT02489344|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters|"Criteria for potentially clinically significant abnormalities:~Creatinine: >=150 micromoles per liter (mcmol/L) (Adults); >=30% change from baseline; >= 100% change from baseline~Blood urea nitrogen: >=17 mmol/L~Urate: <120 mcmol/L; >408 mcmol/L For this analysis, baseline was defined as initial ACT13739 study baseline."|From baseline of ACT13739 study up to 37 months post-ACT13739 baseline|Analysis was performed on safety population: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis.|||Participants|||Count of Participants
2573897|NCT02489344|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters|"Criteria for potentially clinically significant abnormalities:~Glucose: <=3.9 mmol/L and < lower limits of normal (LLN); >=11.1 mmol/L (unfasted [unfas]) or >=7 mmol/L (fasted [fas])~Lipase: >= 3 ULN~C Reactive Protein (CRP): > 2 ULN or > 10 milligrams (mg)/L (if ULN not provided)."|From baseline of ACT13739 study up to 37 months post-ACT13739 baseline|Analysis was performed on safety population: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis.|||Participants|||Count of Participants
2573898|NCT02489344|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters|"Criteria for potentially clinically significant abnormalities:~Alanine Aminotransferase (ALT): >3 ULN; >5 ULN; >10 ULN and >20 ULN~Aspartate aminotransferase (AST): >3 ULN; >5 ULN; >10 ULN and >20 ULN~Alkaline phosphatase: >1.5 ULN~Bilirubin: >1.5 ULN; >2 ULN."|From baseline of ACT13739 study up to 37 months post-ACT13739 baseline|Analysis was performed on safety population: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis.|||Participants|||Count of Participants
2573899|NCT02489344|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes|"Criteria for potentially clinically significant abnormalities:~Sodium: <=129 millimoles (mmol)/L; >=160 mmol/L~Potassium: <3 mmol/L; >=5.5 mmol/L~Chloride: <80 mmol/L; >115 mmol/L."|From baseline of ACT13739 study up to 37 months post-ACT13739 baseline|Analysis was performed on safety population: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis|||Participants|||Count of Participants
2573900|NCT02489344|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters|"Criteria for potentially clinically significant abnormalities:~Hemoglobin: less than or equal to (<=) 115 grams per liter (g/L); greater than or equal to (>=)185 g/L; decreased from baseline (DFB) >=20 g/L~Hematocrit: <=0.37 volume/volume (v/v); >=0.55 v/v~Erythrocytes: >=6 Tera/L~Platelets: lesser than (<) 100 Giga/L; >=700 Giga/L~Leukocytes: <3.0 Giga/L (Non-Black [NB]) or <2.0 Giga/L (Black [B]); >=16.0 Giga/L~Neutrophils: <1.5 Giga/L (NB) or <1.0 Giga/L (B);~Lymphocytes: greater than (>) 4.0 Giga/L~Monocytes: >0.7 Giga/L~Basophils: >0.1 Giga/L~Eosinophils: >0.5 Giga/L or >upper limit of normal (ULN) (if ULN >=0.5 Giga/L) For this analysis, baseline was defined as initial ACT13739 study baseline."|From baseline of ACT13739 study up to 37 months post-ACT13739 baseline|Analysis was performed on safety population: all participants who received at least 1 dose of IMP during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis.|||Participants|||Count of Participants
2573901|NCT02489344|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened during TEAE period (period from the first administration of study drug in ACT13739 through the last administration of the study drug in the combined ACT13739/LTS14116 treatment period plus 1 month or end of study participation for participant, whichever occurred first). For this analysis, baseline was defined as initial ACT13739 study baseline.|From baseline of ACT13739 study up to 37 months post-ACT13739 baseline|Analysis was performed on safety population: all participants who received at least 1 dose of investigational medicinal product (IMP) during the ACT13739 study. All data collected during ACT13739 and LTS14116 studies were included in analysis.|||Participants|||Count of Participants
2573902|NCT02489279|Secondary|Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Hyperactive Subscale|Change was calculated as the score after 10 weeks of treatment minus the pre-treatment score at Baseline. The ASRS is a scale to evaluate ADHD symptoms in adults. The Hyperactive Symptoms Subscale range = 0-36. Higher values are worse. Consequently, a negative difference value indicates improvement.|Baseline and 10 weeks|Completer analysis of all subjects for whom ASRS was measured at Baseline and after completing 10 weeks of treatment.|||units on a scale||Standard Deviation|Mean
2573903|NCT02489279|Secondary|Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Inattentive Subscale|Change was calculated as the score after 10 weeks of treatment minus the pre-treatment score at Baseline. The ASRS is a scale to evaluate ADHD symptoms in adults. The Inattentive Symptoms Subscale range = 0-36. Higher values are worse. Consequently, a negative difference value indicates improvement.|Baseline and 10 weeks|Completer analysis of all subjects for whom Conners CPT RT Variability was measured at Baseline and after completing 10 weeks of treatment.|||units on a scale||Standard Deviation|Mean
2573904|NCT02489279|Primary|Change From Baseline in Nelson-Denny Reading Test - Comprehension Score|Change was calculated as the score after 10 weeks of treatment minus the pre-treatment score at Baseline. The Nelson Denny Reading Comprehension test is a time-limited (20-minute) measure of an important daily life activity that is impaired in ADHD, and impacted by poor sustained attention. The score range is from 0-76 with larger values representing better performance. A larger positive difference value (Post- Pre) indicates an improvement in reading comprehension.|Baseline and 10 weeks|Completer analysis of all subjects for whom Nelson-Denny Reading Comprehension was measured at Baseline and after completing 10 weeks of treatment.|||score on a scale||Standard Deviation|Mean
2573905|NCT02489279|Primary|Change From Baseline in Conners Continuous Performance Test (CPT) RT Variability Scaled Score|Change was calculated as the score after 10 weeks of treatment minus the pre-treatment score at Baseline. This is a computerized continuous performance task yielding a measure of reaction time (RT) variability over the duration of the task as an assessment of sustained attention control. Less variability in RT is a sign of better sustained attention control. The scaled scores are T Scores and the range is 0-100. Smaller values represent better performance (i.e. lower variability). Consequently, a negative difference value (Post-Pre) indicates improvement. This measure directly addresses the training target, inconsistent control of sustained attention (the variability in RT over time), and is highly correlated with ADHD.|Baseline and 10 weeks|Completer analysis of all subjects for whom Conners CPT RT Variability was measured at Baseline and after completing 10 weeks of treatment.|||score on a scale||Standard Deviation|Mean
2573906|NCT02489227|Primary|Difference Between the Percentage of Subjects in Each Treatment Group Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI-75) at Week 12|The efficacy success criterion was the equivalence between CHS-1420 and Humira at Week 12. Equivalence was based upon 2-sided 95% confidence interval (CI) for the difference between the proportions of subjects in the CHS-1420 and Humira groups achieving PASI-75 at Week 12. If the 95% CI lay entirely within the interval (-15%, 15%), equivalence was established.|12 weeks||||Participants|||Count of Participants
2573907|NCT02489110|Secondary|Caregiver Burden on the Revised Memory and Behavior Problems Checklist|"This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this bothered or upset them. A conditional bother score is calculated which is the upset or bother ratings for only the problematic behavior that occurred. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome."|3 months|"Two (2) subjects in the Webnovela group completed the study, but they did not have full data related to the Secondary Outcome Caregiver Burden on the Revised Memory and Behavior Problems Checklist. These subjects were not included in this data analysis."|||units on a scale||Standard Deviation|Mean
2573908|NCT02489110|Primary|Stress on the Perceived Stress Scale|"The Perceived Stress Scale measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome."|3 months|"One (1) subject in the Webnovela group and one (1) subject in the Control group completed the study, but they did not have full data related to the Primary Outcome Stress on the Perceived Stress Scale. These subjects were not included in this data analysis."|||units on a scale||Standard Deviation|Mean
2573909|NCT02488980|Other Pre-specified|Safety (SAEs and AEs)|The most commonly reported experiences in subject occurring in at least 20% of subjects in any treatment group.|28 weeks||||participants|||Number
2573910|NCT02488980|Secondary|Time to a Single Positive Smear|Kaplan-Meier survival curves were produced for time to parasitaemia for both first positive smear and two consecutive positive smears. 95.5% confidence intervals were constructed for the relative risk.|24 Weeks||||Days||95% Confidence Interval|Median
2573911|NCT02488980|Secondary|Protective Efficacy Based on Two Consecutive Positive Smears|Kaplan-Meier survival curves were produced for time to parasitaemia for both first positive smear and two consecutive positive smears. Analysis was based on a calculation of protective efficacy (PE) of tefaenoquine, defined as (1-relative risk of developing parasitaemia tafenoquine: placebo) x100% and 95.5% confidence intervals were constructed for the relative risk using Koopman's method.|24 Weeks||||Percentage of Protective Efficacy||95% Confidence Interval|Number
2573912|NCT02488980|Primary|Prophylactic Outcome Defined by the Subject Having no Positive Smears|Prophylactic outcome (success/failure) at the end of the prophylactic treatment phase; outcome was based on absence/presence of asexual stage parasites of any Plasmodium species on a single blood smear.|24 Weeks||||participants|||Number
2573913|NCT02488915|Post-Hoc|Proportion of Subjects With New Territory Embolisation|Embolisation of any new territories was recorded directly post-treatment.|Post-treatment||||Participants|||Count of Participants
2573914|NCT02488915|Secondary|Time to Treat|"The time from first baseline angiogram to achievement of mTICI ≥2b, or if not obtained, to the final angiogram.~-~mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke:~mTICI 0 = No perfusion~mTICI 1 = Penetration but not perfusion~mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized~mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized~mTICI 2c = Near-complete perfusion~mTICI 3 = Complete perfusion"|Post-treatment||||minutes||Inter-Quartile Range|Median
2573915|NCT02488915|Secondary|Proportion of Subjects With Evidence of Infarction of a Previously Uninvolved Vascular Territory|Infarction (i.e. brain tissue death) of a previously uninvolved vascular territory (i.e. region of the brain) is evaluated from 24-hour imaging (Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)).|24(-8/+12) hours post-procedure||||Participants|||Count of Participants
2573916|NCT02488915|Secondary|Occurrence of Neurological Deterioration|An increase of 4 points or more on the National Institutes of Health Stroke Scale (NIHSS) at 24 hours (-8/+12 hrs) post-procedure. The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.|24(-8/+12) hours post-procedure|Denominator exclude missing data. Participant who were not assessed for NIHSS at 24hrs and/or those who used rescue therapy at any time during the procedure were treated as missing data.|||Participants|||Count of Participants
2573917|NCT02488915|Secondary|Occurrence of Symptomatic Intracerebral Hemorrhage (sICH)|sICH was assessed using the Heidelberg Bleeding Classification, i.e. any intracerebral hemorrhage associated with an increase of ≥4 points in the NIHSS scale or an increase of ≥2 points of a NIHSS subcategory or that leads to major medical intervention.|24(-8/+12) hours post-procedure||||Participants|||Count of Participants
2573918|NCT02488915|Secondary|Occurrence of Procedure Related Serious Adverse Events (PRSAE)|PRSAE was categorized as any serious adverse event that was deemed to be caused by the study procedure.|90(±14) days Post Procedure||||Participants|||Count of Participants
2573919|NCT02488915|Secondary|Occurrence of Serious Adverse Device Effects (SADE)|SADE was categorized as any serious adverse event that was deemed to be caused by the study device.|90(±14) days Post Procedure||||Participants|||Count of Participants
2573920|NCT02488915|Secondary|All-cause Mortality|Any death that occurs within 90(±14) days post-procedure.|90(±14) days Post Procedure|Denominator excludes missing data. Participants who were Lost to Follow-up and Withdrew Consent were treated as missing data.|||Participants|||Count of Participants
2573921|NCT02488915|Secondary|All Procedure-related Mortality|Any death that is deemed to have been caused by the study procedure.|Day 7 post-procedure||||Participants|||Count of Participants
2573922|NCT02488915|Secondary|Procedure Time|"The time from groin puncture to achievement of mTICI ≥2b, or if not obtained, to the final angiogram.~-~mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke:~mTICI 0 = No perfusion~mTICI 1 = Penetration but not perfusion~mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized~mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized~mTICI 2c = Near-complete perfusion~mTICI 3 = Complete perfusion"|Post-treatment||||minutes||Inter-Quartile Range|Median
2573923|NCT02488915|Secondary|Good Clinical Outcome as Defined by Modified Rankin Scale (mRS) Score ≤2|"Good Clinical Outcome is defined as achieving an mRS score of ≤2 at 90 days post procedure.~-~mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. mRS scores range from 0 to 6:~mRS 0 = No symptoms.~mRS 1 = No significant disability.~mRS 2 = Slight disability.~mRS 3 = Moderate disability.~mRS 4 = Moderately severe disability.~mRS 5 = Severe disability.~mRS 6 = Dead."|90(±14) days Post Procedure|All patients enrolled and treated with the EmboTrap device for whom there is known data, including those who were subsequently treated with other therapies. However, outcome data excludes cases where the patient withdrew consent or was lost to follow up, with undefined/unknown scores.|||Participants|||Count of Participants
2574695|NCT02478359|Secondary|General Anxiety Disorder, GAD-7 - 12 Months|The reported mean change between the baseline and 12 Months scores. Score range is 0-21. A negative change score indicates less anxiety.|12 months|As treated population who completed the survey|||score on a scale||Standard Deviation|Mean
2573924|NCT02488915|Primary|Occurrence of Symptomatic Intracerebral Hemorrhage (sICH) Within 24 Hours Post-procedure and Any Other Serious Adverse Device Effects (SADE)|"The primary safety endpoint will be measured as the occurrence of Symptomatic Intracerebral hemorrhage (sICH) within 24 hours (-8/+12 hrs) post-procedure, together with any other Serious Adverse Device Effects (excluding those already counted in sICH).~sICH was assessed using the Heidelberg Bleeding Classification, i.e. any intracerebral hemorrhage associated with an increase of ≥4 points in the NIHSS scale or an increase of ≥2 points of a NIHSS subcategory or that leads to major medical intervention. SADE was categorized as any serious adverse event that was deemed to be caused by the study device."|24(-8/+12 hrs) hours post-procedure and 90(±14) days Post Procedure||||Participants|||Count of Participants
2573925|NCT02488915|Primary|Successful Revascularization Measured Using Modified Thrombolysis in Cerebrovascular Infarction (mTICI Inclusive of the 2c Rating)|"Successful achievement of the endpoint is defined as achieving an mTICI score of 2b or greater in the target vessel following 3 or less passes of the EmboTrap device. Patients treated with rescue prior to completion of three passes with EmboTrap were treated as failures to meet the primary revascularization endpoint. (Post measurement of the primary endpoint some patients subsequently received additional treatment.)~-~mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke:~mTICI 0 = No perfusion~mTICI 1 = Penetration but not perfusion~mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized~mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized~mTICI 2c = Near-complete perfusion~mTICI 3 = Complete perfusion"|Post-treatment|Analysis population includes all patients enrolled and treated with the EmboTrap device (N=227) irrespective of whether they met all incl/excl criteria.|||Participants|||Count of Participants
2573926|NCT02488824|Secondary|Change in Thermal Sensitivity From Baseline to 120 Minutes Post Warm Challenge|The investigators measured the effects of warm temperature (95 F) exposure, of up to 120 minutes, on the change in thermal sensitivity in the seated position on the 9-Point Thermal sensation scale (+4=very hot, +3=hot, +2=warm, +1=slightly warm, 0=neutral, -1=slightly cool, -2=cool, -3=cold, -4=very cold). A higher score means the subject feels hotter, which, for the identical heat challenge, means less effective thermoregulation.|From Baseline to 120 Minutes||||score on a scale||Standard Deviation|Mean
2573927|NCT02488824|Secondary|Change in Sweat Rate From Baseline to 120 Minutes Post Warm Challenge|The investigators measured the effects of warm temperature (95 F) exposure, of up to 120 minutes, on the change in sweat rate in the seated position.|From Baseline to 120 Minutes||||nL/min||Standard Deviation|Mean
2573928|NCT02488824|Secondary|Change in Distal Skin Temperatures From Baseline to 120 Minutes Post Warm Challenge|The investigators measured the effects of warm temperature (95 F) exposure, of up to 120 minutes, on the change in distal skin temperatures in the seated position.|From Baseline to 120 Minutes||||degrees Centigrade||Standard Deviation|Mean
2573929|NCT02488824|Primary|Change in Cognitive Performance From Baseline to 120 Minutes Post Warm Challenge|"Cognitive performance was assessed using a neuropsychological battery. Cognitive performance was assessed at 2 time points, at the end of baseline and after heat exposure (warm challenge) in both groups of subjects.~The Stroop Word test measures processing speed. A T-Score of 50 means 0 difference of actual - predicted score (based on subject's age & education level). T-Scores <40 are considered low; T-Scores >40 are considered normal. Changes of 10 or greater are considered clinically significant. The lowest possible T-Score is 21; the highest possible T-Score is 80.~The WAIS-IV Digit Span Sequencing measures auditory processing and working memory. Each test score is converted to a scaled score (M=10, SD=3) with higher scores considered better performance. The lowest possible scaled score is 1; the highest possible scaled score is 19."|From Baseline to 120 Minutes||||Scores on a scale||Standard Deviation|Mean
2573930|NCT02488824|Primary|Change in Core Body Temperature From Baseline to 120 Minutes Post Warm Challenge|The investigators measured the effects of warm temperature (95 F) exposure, of up to 120 minutes, on the ability to maintain a constant body temperature (e.g., core temperature of 98.6 F) in both groups of subjects. Core temperature was measured at baseline (thermoneutral) and after 120 minutes of warm temperature exposure (Warm Challenge). The change in core temperature from baseline to 120 minutes of Warm Challenge was calculated.|From Baseline to 120 Minutes||||degrees Centigrade||Standard Deviation|Mean
2573931|NCT02488681|Primary|Complications|Micra system and/or procedure-related complication rate|3 months post last follow up|All subjects who attempted Micra implant procedure|||% participants with complication||95% Confidence Interval|Number
2573932|NCT02488330|Primary|Percentage of Participants With Serious Adverse Events Considered Related to Onartuzumab|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline through the end of trial (approximately 3 years)||||Percent|||Number
2573933|NCT02488317|Primary|Preparation for Decision Making|"Measured using Bennett, Carol, Validation of a Preparation for Decision Making Scale. Patient Education and Counseling 78, no. 1: 130-33 10 item scale, each item scored from 1 (not at all) to 5 (a great deal). items are summed and scored, converted to a 0-100 scale by subtracting 1 from the summed score and multiplying by 25. Higher scores indicate higher perceived level of preparation for decision making."|6 months|This was a comparison of the intervention group before and after using the decision aid to assess its impact on preparing the participant for decision making. The question was therefore not administered to the control group since a similar pre/post comparison could not be tested in this group that was not exposed to the intervention.|||units on a scale||Standard Deviation|Mean
2573934|NCT02488317|Primary|Knowledge|"Measured using scale from Cavanaugh KPatient Dialysis Knowledge Is Associated with Permanent Arteriovenous Access Use in Chronic Hemodialysis. Clinical Journal of the American Society of Nephrology 4, no. 5: 950-56) Multiple choice questions with one correct answer per questions. Number of correct questions reported as a percentage of total number of questions (23)."|6 months|All participants who completed the questionnaire were included in these analyses.|||scores on a scale||Standard Deviation|Mean
2573935|NCT02488317|Primary|Decision Self-efficacy|"Measured through the scale found in Decision Self-Efficacy Ottawa: Ottawa Hospital Research Institute; © 1995 Available from: http://decisionaid.ohri.ca/docs/develop/User_Manuals/UM_Decision_SelfEfficacy.pdf O'Connor 1995 Items are scored 0(not at all confident) to 4 (very confident). Scores are summed across 10 items, divided by 10 and multiplied by 25. Scores range from 0-100. A score of 0 means extremely low self efficacy and a score of 100 means extremely high self efficacy."|6 months|All participants who completed the questionnaire were included in these analyses.|||scores on a scale||Standard Deviation|Mean
2573936|NCT02488317|Primary|Decisional Conflict|"Measured using the scale from O'Connor, Annette M. Validation of a Decisional Conflict Scale. Medical Decision Making 15, no. 1 (February 1, 1995): 25-30. 16 item scale, responses to each statement are scored from 1 (strongly agree) to 5 (strongly disagree), with negative statements having reverse scoring; thus high scores indicate higher decisional conflict. Mean score per participant is calculated across all items, subtract by 1 and multiplied by 25. Score range= 0-100. Mean scores across all participants in each arm are reported."|6 months|All participants who completed the questionnaire were included in these analyses.|||scores on a scale||Standard Deviation|Mean
2573937|NCT02488317|Primary|Preference for Shared Decision Making|Measured using the scale from Degner, L. F., Sloan, J. A., & Venkatesh, P. (1996). The Control Preferences Scale. The Canadian journal of nursing research= Revue canadienne de recherche en sciences infirmieres, 29(3), 21-43. The CPS is a clinically relevant, easily administered, valid, and reliable measure of preferred roles in health-care decision-making. A pick-one approach was used to identify patient preference for an active, passive or collaborative role in dialysis treatment decision making.|6 months||||participants|||Number
2573938|NCT02488239|Primary|LV Pacing Threshold|Primary Effectiveness endpoint: evaluation of the left ventricular pacing threshold measurements performed at 0.5 ms pulse width at 3 months post-implant.|3 months post-implant|61 actively enrolled subjects were included in the analysis. 3 subjects did not receive the study device.|||Volt||90% Confidence Interval|Mean
2573939|NCT02488239|Primary|Percentage of Participants Without CRT-P Device Related Complications|Evaluate the Device-Related Complication Free Rate (DRCFR) at 3 months post-implant, which was based on complications that were related to the CRT-P device. A device-related complication was an adverse event that resulted in death, serious injury, a correction using invasive intervention or permanent loss of device functions, and that was assessed as related to the device.|3 months post-implant|Out of 61 actively enrolled subjects (3 subjects were not implanted with the study device), 55 patients continued the study for at least 3 months: 6 subjects were excluded from analysis because either they died or withdrew before 3 months analysis, or because no 3 months data was available.|||% of participants||90% Confidence Interval|Number
2573940|NCT02488070|Secondary|Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan|Feasibility of Ga68 PSMA PET/CT or PET/MRI is expressed as the number of subjects for whom the scan was successfully completed.|an estimated average of 2 hours|The population analyzed included all participants receiving Ga-68 PSMA PET/CT or PET/MRI scan.|||participants|||Number
2573941|NCT02488070|Primary|Average SUVmean Focal Uptake of Ga68 PSMA (F/N Ratio)|Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean (a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background.|an estimated average of 1 hour|45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmean. The mediastinal blood pool was used to determine average background.|||F/N ratio||Standard Deviation|Mean
2573942|NCT02488070|Primary|Average SUVmax Focal Uptake of Ga68 PSMA (F/N Ratio)|Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmax (a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background.|an estimated average of 1 hour|45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmax. The mediastinal blood pool was used to determine average background.|||F/N ratio||Standard Deviation|Mean
2573943|NCT02488070|Primary|Average SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution|The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean which is a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI.|an estimated average of 1 hour|45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmean. The mediastinal blood pool was used to determine average background.|||SUVmean||Standard Deviation|Mean
2573944|NCT02488070|Primary|Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution|The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a standardized uptake value maximum (SUVmax), which is a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI.|an estimated average of 1 hour|45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmax. The mediastinal blood pool was used to determine average background.|||SUVmax||Standard Deviation|Mean
2573962|NCT02487810|Secondary|Correlation Between Accepting Antibiotics and Thinking That Living in a Nursing Home is Equal to or Worse Than Death|This outcome measures the proportion of participants who accept antibiotics AND indicate that living in a nursing home is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.|The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally||||Participants|||Count of Participants
2573945|NCT02488018|Primary|Examine Effect of Monofloral Honey Types on Glycemic Index of Health Human Subjects|Ten healthy individuals consumed monofloral honeys (25g of available carbohydrate in 250 mL water) after fasting for 11 hours. Blood glucose levels (mmol/L) were recorded at 0, 15, 30, 45, 60, 90 and 120 minutes. Time (0, 15, 30, 45, 60, 90 and 120 minutes) verse blood glucose levels (mmol/L) used to establish the area under the curve (AUC) for the honeys and reference glucose. This was used to calculate the glycemic index of honey each honey (GI= AUC for honey/AUC for reference glucose*100). All 10 participants took eight different honeys and reference glucose on nine different days (with randomized allocation of samples).|36 days (9 tests in 4 days interval)|All 10 participants took, 25g available carbohydrate of eight different honeys and reference glucose, on nine different days in 4 days interval. Blood was taken from finger prick using automatic lancet at 0, 15, 30, 45, 60, 90 and 120 minutes; glucose levels were recorded and area under the blood glucose curve was calculated.|||Index||Standard Deviation|Mean
2573946|NCT02488005|Secondary|Anti-infliximab Antibodies (ATI)|Anti-infliximab antibodies at week 14.|Week 14||||U/mL||Full Range|Median
2573947|NCT02488005|Secondary|IFX Level|Infliximab drug (IFX) level at week 14. normal levels are <0.4 µg/mL|Week 14||||µg/mL||Full Range|Median
2573948|NCT02488005|Secondary|Change in Erythrocyte Sedimentation Rate (ESR)|Change in Erythrocyte Sedimentation Rate (ESR) blood level at Week 14 from baseline|baseline and 14 weeks||||mm/hr||Full Range|Median
2573949|NCT02488005|Secondary|C-Reactive Protein|C-Reactive Protein (CRP) blood level|14 weeks||||mg/L||Full Range|Median
2573950|NCT02488005|Secondary|Change in Fecal Calprotectin|change in fecal calprotectin at week 14 compared to baseline, using a specimen collection kit given to subjects|Baseline and Week 14||||mcg/g||Full Range|Median
2573951|NCT02488005|Primary|Change in Weighted Pediatric Crohn's Disease Activity Index (wPCDAI)|wPCDAI at week 14 as compared to baseline. PCDAI includes three history items (abdominal pain, number of liquid stools, general wellbeing), five physical examination items (abdominal examination, perirectal disease, extraintestinal manifestations, weight, height), and three laboratory tests (hematocrit, albumin, erythrocyte sedimentation rate). Items are scored on a three-point scale (zero, 5, or 10 points) except for hematocrit and erythrocyte sedimentation rate which are scored as zero, 2.5 or 5 points. PCDAI scores can range from zero to 125 with higher scores indicating more active disease.|Baseline and Week 14||||score on a scale||Full Range|Median
2573952|NCT02488005|Primary|Change in Bowel Wall Thickness (BWT)|Change in Bowel Wall Thickness at week 14 as compared to baseline, prior to initiating infliximab (IFX 0).|Baseline and Week 14||||mm||Full Range|Median
2573953|NCT02487979|Secondary|RECIST Response|The number of patients who experience a complete or partial response according the RECIST criteria for target lesions complete response (CR) disappearance of all lesions; partial response (PR ) >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.|First six cycles (21-day cycle) of protocol therapy||||Participants|||Count of Participants
2573954|NCT02487979|Secondary|Number of Participants With Glycoprotein NMB (GPNMB) Expression Stratified by Immunohistochemistry (IHC) Staining Strength|GPNMB expression by IHC of 0+ to 3+ staining strength as assessed on archived tumor specimens. 0 being no GPNMB expression and 3 indicating strong GPNMB expression.|Prior to the time of enrollment|Analysis was successfully completed for 19 patients|||Participants|||Count of Participants
2573955|NCT02487979|Secondary|Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Areas Under the Curve|Total antibody and antibody-drug conjugate areas under the curve are estimated from the sampling time points: Before first dose (Baseline), end of infusion, at 1, 2, 4, and 24 hours post infusion|Baseline to 24 hours post infusion on course 1|Samples were provided for four patients|||hour-microgram per millilitre||Standard Deviation|Mean
2573956|NCT02487979|Secondary|Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Clearance|Total antibody and antibody-drug conjugate clearance are estimated from the sampling time points: Before first dose (Baseline), end of infusion, at 1, 2, 4, and 24 hours post infusion|Baseline to 24 hours post infusion on course 1|Samples were provided for four patients|||millilitres per hour per kilogram||Standard Deviation|Mean
2573957|NCT02487979|Secondary|Pharmacokinetics of Glembatumumab Vedotin: Total Antibody and Antibody-drug Conjugate Half-life|Total antibody and antibody-drug conjugate half-life are estimated from the sampling time points: Before first dose (Baseline), end of infusion, at 1, 2, 4, and 24 hours post infusion|Baseline to 24 hours post infusion on course 1|Samples were provided for four patients|||hours||Standard Deviation|Mean
2573958|NCT02487979|Secondary|Toxicity Associated With Chemotherapy|The number of cycles aggregated across all patients where CTC Version 4 grade 3 or higher.|Duration of protocol therapy - Up to two years|22 patients were treated on protocol therapy. Sixty-one (61) cycles were reported for the analysis of toxicity.|||cycles|||Number
2573959|NCT02487979|Primary|Disease Control Success|The number of patients who do not experience disease progression or death in the six cycles following enrollment on AOST1521|First six cycles (21-day cycle) of protocol therapy||||Participants|||Count of Participants
2573960|NCT02487810|Secondary|Correlation Between Accepting a Feeding Tube and Thinking That Relying on a Feeding Tube is Equal to or Worse Than Death|This outcome measures the proportion of participants who accept a feeding tube AND indicate that relying on a feeding tube is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.|The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally||||Participants|||Count of Participants
2573961|NCT02487810|Secondary|Correlation Between Accepting Tracheostomy and Thinking That Relying on a Breathing Machine is Equal to or Worse Than Death|This outcome measures the proportion of participants who accept tracheostomy AND indicate that relying on a breathing machine is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.|The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally||||Participants|||Count of Participants
2574450|NCT02482129|Secondary|Use of Rescue Treatment|Use of rescue treatment is presented as the number of subjects with first use of rescue treatment by visit. Subjects receiving rescue medication were not considered withdrawn and the collection of data continued after discontinuation of study treatment. Only one eye contributed to the analysis.|Day 4, Day 8, Day 15|Per Protocol Analysis Set|||Participants|||Count of Participants
2573963|NCT02487810|Secondary|Correlation Between Accepting Tracheostomy and Thinking That Living in a Nursing Home is Equal to or Worse Than Death|This outcome measures the proportion of participants who accept tracheostomy AND indicate that living in a nursing home is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.|The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally||||Participants|||Count of Participants
2573964|NCT02487810|Secondary|Correlation Between Accepting Antibiotics and Thinking That Needing Care All the Time is Equal to or Worse Than Death|This outcome measures the proportion of participants who accept antibiotics AND indicate that needing care all the time is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.|The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally||||Participants|||Count of Participants
2573965|NCT02487810|Secondary|Correlation Between Accepting Tracheostomy and Thinking That Needing Care All the Time is Equal to or Worse Than Death|This outcome measures the proportion of participants who accept tracheostomy AND indicate that needing care all the time is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.|The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally||||Participants|||Count of Participants
2573966|NCT02487810|Secondary|Correlation Between Accepting Antibiotics and Thinking That Being Bed Bound is Equal to or Worse Than Death.|This outcome measures the proportion of participants who accept antibiotics AND indicate that bed bound is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.|The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally||||Participants|||Count of Participants
2573967|NCT02487810|Secondary|Correlation Between Accepting Tracheostomy and Thinking That Being Bed Bound is Equal to or Worse Than Death|This outcome measures the proportion of participants who accept tracheostomy AND indicate that bed bound is a state that is either equal to, or worse than death. This proportion will be measured separately in the deliberative and intuitive groups; these proportions will then be compared.|The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally||||Participants|||Count of Participants
2573968|NCT02487810|Secondary|Scores on Uncertainty Subscale of Decisional Conflict Scale|Decisional uncertainty will be evaluated using the uncertainty subscale of the Decisional Conflict Scale ranging from 0-100 such that 0 = extremely CERTAIN about best choice and 100 = extremely UNCERTAIN about the best choice. Higher values represent MORE UNCERTAINTY with decisions regarding feeding tubes, antibiotics, intubation, and tracheostomy while lower values represent LESS UNCERTAINTY.|The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally||||units on a scale||Standard Deviation|Mean
2573969|NCT02487810|Primary|Acceptance or Refusal of Tracheostomy|Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding acceptance of a tracheostomy and support from a breathing machine for at least two months to survive. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions. Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.|The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally||||Participants|||Count of Participants
2573970|NCT02487810|Primary|Acceptance or Refusal of Breathing Machine|Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding acceptance of a breathing machine. In this hypothetical scenario, patients are presented with a life-threatening illness with 50% chance of survival provided that they receive support from a breathing machine for two weeks. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions. Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.|The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally||||Participants|||Count of Participants
2573971|NCT02487810|Primary|Acceptance or Refusal of Antibiotics|Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding acceptance of antibiotics. In this hypothetical scenario, patients are presented with an illness severity such that they drift in and out of consciousness some days and are expected to die in several months. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions. Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.|The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally||||Participants|||Count of Participants
2573972|NCT02487810|Primary|Acceptance or Refusal of a Feeding Tube for Chronic Aspiration|Patients in each arm will be asked all of the same questions. The only difference between the arms will be the instructions regarding how and when to answer the series of hypothetical questions regarding acceptance of a feeding tube for chronic aspiration. In this hypothetical scenario, patients are presented with a situation in which they are unable to eat or drink safely such that small amounts of food or liquid go to their lungs and cause trouble with breathing. The instructions will be designed to influence patients to think either intuitively or deliberatively about the questions regarding life-sustaining interventions. Cognitive load: Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.|The trial involves a questionnaire that will be given on a single day; patients will not be followed longitudinally||||Participants|||Count of Participants
2573977|NCT02487771|Post-Hoc|Anthropometrics: Body Composition|Child body composition was measured between 5 and 6 years of age by BOD POD air displacement plethysmography (COSMED, Concord, CA, USA). Methods adhered to standard testing protocol (tight-fitting one-piece swimsuit and swim cap, duplicate or triplicate measure of body volume and predicted thoracic gas volume). Fat and fat free mass to the nearest 0.1 kg are presented as means with standard deviations. Normative data are not available in this pediatric population.|5 to 5.5 years old|Missing data due to attrition, missed appointments or refusals|||Kilogram (kg)||Standard Deviation|Mean
2573978|NCT02487771|Other Pre-specified|Heart Rate|Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|4 years|Missing data due to attrition, missed appointments or refusals|||Beats per minute (BPM)||Standard Deviation|Mean
2573979|NCT02487771|Other Pre-specified|Diastolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|6 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2573980|NCT02487771|Other Pre-specified|Diastolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|5.5 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2573981|NCT02487771|Other Pre-specified|Diastolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|5 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2573982|NCT02487771|Other Pre-specified|Diastolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|4.5 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2573983|NCT02487771|Other Pre-specified|Diastolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|4 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2573984|NCT02487771|Other Pre-specified|Systolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|6 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2573985|NCT02487771|Other Pre-specified|Systolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|5.5 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2573986|NCT02487771|Other Pre-specified|Systolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|5 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2573987|NCT02487771|Other Pre-specified|Systolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|4.5 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2573988|NCT02487771|Other Pre-specified|Systolic Blood Pressure|Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.|4 years|Missing data due to attrition, missed appointments or refusals|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2573989|NCT02487771|Other Pre-specified|Dietary Intake|Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.|6 years|Missing data due to attrition, missed appointments, refusals or questionable intake|||kilocalorie||Standard Deviation|Mean
2573998|NCT02487771|Other Pre-specified|Anthropometrics: Head Circumference-for-age|Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.|6 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
2573990|NCT02487771|Other Pre-specified|Dietary Intake|Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.|5.5 years|Missing data due to attrition, missed appointments, refusals or questionable intake|||kilocalorie||Standard Deviation|Mean
2573991|NCT02487771|Other Pre-specified|Dietary Intake|Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.|5 years|Missing data due to attrition, missed appointments, refusals or questionable intake|||kilocalorie||Standard Deviation|Mean
2573992|NCT02487771|Other Pre-specified|Dietary Intake|Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.|4.5 years|Missing data due to attrition, missed appointments, refusals or questionable intake|||kilocalorie||Standard Deviation|Mean
2573993|NCT02487771|Other Pre-specified|Dietary Intake|Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.|4 years|Missing data due to attrition, missed appointments, refusals or questionable intake|||kilocalorie||Standard Deviation|Mean
2573994|NCT02487771|Other Pre-specified|Dietary Intake|Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.|3.5 years|Missing data due to attrition, missed appointments, refusals or questionable intake|||kilocalorie||Standard Deviation|Mean
2573995|NCT02487771|Other Pre-specified|Dietary Intake|Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.|3 years|Missing data due to attrition, missed appointments, refusals or questionable intake|||kilocalorie||Standard Deviation|Mean
2573996|NCT02487771|Other Pre-specified|Dietary Intake|Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.|2.5 years|Missing data due to attrition, missed appointments, refusals or questionable intake|||kilocalorie||Standard Deviation|Mean
2573997|NCT02487771|Other Pre-specified|Dietary Intake|Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.|2 years|Missing data due to attrition, missed appointments, refusals or questionable intake|||kilocalorie||Standard Deviation|Mean
2574033|NCT02487771|Other Pre-specified|Anthropometrics: Weight-for-age|Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).|2 years|Missing data due to attrition, missed appointments or refusals|||Kilogram (kg)||Standard Deviation|Mean
2573999|NCT02487771|Other Pre-specified|Anthropometrics: Head Circumference-for-age|Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.|5.5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
2574000|NCT02487771|Other Pre-specified|Anthropometrics: Head Circumference-for-age|Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.|5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
2574001|NCT02487771|Other Pre-specified|Anthropometrics: Head Circumference-for-age|Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.|4.5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
2574002|NCT02487771|Other Pre-specified|Anthropometrics: Head Circumference-for-age|Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.|4 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
2574003|NCT02487771|Other Pre-specified|Anthropometrics: Head Circumference-for-age|Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.|3.5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
2574004|NCT02487771|Other Pre-specified|Anthropometrics: Head Circumference-for-age|Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.|3 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
2574005|NCT02487771|Other Pre-specified|Anthropometrics: Head Circumference-for-age|Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.|2.5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
2574006|NCT02487771|Other Pre-specified|Anthropometrics: Head Circumference-for-age|Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.|2 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
2574007|NCT02487771|Other Pre-specified|Anthropometrics: Body Mass Index-for-age|Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.|6 years|Missing data due to attrition, missed appointments or refusals|||Body mass index (kg/m2)||Standard Deviation|Mean
2574008|NCT02487771|Other Pre-specified|Anthropometrics: Body Mass Index-for-age|Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.|5.5 years|Missing data due to attrition, missed appointments or refusals|||Body mass index (kg/m2)||Standard Deviation|Mean
2574009|NCT02487771|Other Pre-specified|Anthropometrics: Body Mass Index-for-age|Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.|5 years|Missing data due to attrition, missed appointments or refusals|||Body mass index (kg/m2)||Standard Deviation|Mean
2574010|NCT02487771|Other Pre-specified|Anthropometrics: Body Mass Index-for-age|Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.|4.5 years|Missing data due to attrition, missed appointments or refusals|||Body mass index (kg/m2)||Standard Deviation|Mean
2574011|NCT02487771|Other Pre-specified|Anthropometrics: Body Mass Index-for-age|Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.|4 years|Missing data due to attrition, missed appointments or refusals|||Body mass index (kg/m2)||Standard Deviation|Mean
2574012|NCT02487771|Other Pre-specified|Anthropometrics: Body Mass Index-for-age|Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.|3.5 years|Missing data due to attrition, missed appointments or refusals|||Body mass index (kg/m2)||Standard Deviation|Mean
2574013|NCT02487771|Other Pre-specified|Anthropometrics: Body Mass Index-for-age|Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.|3 years|Missing data due to attrition, missed appointments or refusals|||Body mass index (kg/m2)||Standard Deviation|Mean
2574014|NCT02487771|Other Pre-specified|Anthropometrics: Body Mass Index-for-age|Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.|2.5 years|Missing data due to attrition, missed appointments or refusals|||Body mass index (kg/m2)||Standard Deviation|Mean
2574015|NCT02487771|Other Pre-specified|Anthropometrics: Body Mass Index-for-age|Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.|2 years|Missing data due to attrition, missed appointments or refusals|||Body mass index (kg/m^2)||Standard Deviation|Mean
2574465|NCT02481596|Secondary|Obstructive Family Behaviors|as measured by Family and Friend Involvement in Adults' Diabetes (FIAD) harmful involvement subscale ranging from 1= less frequent harmful involvement (better) to 5=more frequent harmful involvement (worse)|3 months, 6 months||||score on a scale||Inter-Quartile Range|Median
2574016|NCT02487771|Other Pre-specified|Anthropometrics: Height-for-Age|Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.|6 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
2574017|NCT02487771|Other Pre-specified|Anthropometrics: Height-for-Age|Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.|5.5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
2574018|NCT02487771|Other Pre-specified|Anthropometrics: Height-for-Age|Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.|5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
2574019|NCT02487771|Other Pre-specified|Anthropometrics: Height-for-Age|Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.|4.5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
2574020|NCT02487771|Other Pre-specified|Anthropometrics: Height-for-Age|Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.|4 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
2574021|NCT02487771|Other Pre-specified|Anthropometrics: Height-for-Age|Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.|3.5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
2574022|NCT02487771|Other Pre-specified|Anthropometrics: Height-for-Age|Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.|3 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
2574023|NCT02487771|Other Pre-specified|Anthropometrics: Height-for-Age|Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.|2.5 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
2574024|NCT02487771|Other Pre-specified|Anthropometrics: Weight-for-age|Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).|6 years|Missing data due to attrition, missed appointments or refusals|||Kilogram (kg)||Standard Deviation|Mean
2574025|NCT02487771|Other Pre-specified|Anthropometrics: Weight-for-age|Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).|5.5 years|Missing data due to attrition, missed appointments or refusals|||Kilogram (kg)||Standard Deviation|Mean
2574026|NCT02487771|Other Pre-specified|Anthropometrics: Weight-for-age|Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).|5 years|Missing data due to attrition, missed appointments or refusals|||Kilogram (kg)||Standard Deviation|Mean
2574027|NCT02487771|Other Pre-specified|Anthropometrics: Weight-for-age|Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).|4.5 years||||Kilogram (kg)||Standard Deviation|Mean
2574028|NCT02487771|Other Pre-specified|Anthropometrics: Weight-for-age|Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).|4 years|Missing data due to attrition, missed appointments or refusals|||Kilogram (kg)||Standard Deviation|Mean
2574029|NCT02487771|Other Pre-specified|Anthropometrics: Weight-for-age|Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).|3.5 years|Missing data due to attrition, missed appointments or refusals|||Kilogram (kg)||Standard Deviation|Mean
2574030|NCT02487771|Other Pre-specified|Anthropometrics: Height-for-Age|Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.|2 years|Missing data due to attrition, missed appointments or refusals|||Centimeters (cm)||Standard Deviation|Mean
2574031|NCT02487771|Other Pre-specified|Anthropometrics: Weight-for-age|Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).|3 years|Missing data due to attrition, missed appointments or refusals|||Kilogram (kg)||Standard Deviation|Mean
2574032|NCT02487771|Other Pre-specified|Anthropometrics: Weight-for-age|Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).|2.5 years|Missing data due to attrition, missed appointments or refusals|||Kilogram (kg)||Standard Deviation|Mean
2574034|NCT02487771|Secondary|Adaptive Regulation Assessment|The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.|72 Months|Missing data due to attrition, missed appointments, refusals.|||T-scores||Standard Deviation|Mean
2574035|NCT02487771|Secondary|Adaptive Regulation Assessment|The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.|60 Months|Missing data due to attrition, missed appointments, refusals.|||T-scores||Standard Deviation|Mean
2574036|NCT02487771|Secondary|Adaptive Regulation Assessment|The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.|48 Months|Missing data due to attrition, missed appointments, refusals.|||T-scores||Standard Deviation|Mean
2574037|NCT02487771|Secondary|Adaptive Regulation Assessment|The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.|36 Months|Missing data due to attrition, missed appointments, refusals.|||T-scores||Standard Deviation|Mean
2574038|NCT02487771|Primary|Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ|The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.|72 Months|Missing data due to attrition, missed appointments, refusals, or questionable test|||units on a scale||Standard Deviation|Mean
2574039|NCT02487771|Primary|Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ|The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.|48 Months|Missing data due to attrition, missed appointments, refusals, or questionable test|||units on a scale||Standard Deviation|Mean
2574040|NCT02487771|Primary|Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ|The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.|36 Months|Missing data due to attrition, missed appointments, refusals, or questionable test|||units on a scale||Standard Deviation|Mean
2574041|NCT02487771|Primary|Cognitive Function Score - Test of Preschool Early Literacy|The Test of Preschool Early Literacy provides a standardized Early Literacy Index score, a measure of general, early literacy skills that relate to later reading and writing skill acquisition. The score is based on assessments of vocabulary, print knowledge, and phonological awareness. The score can range from 40 (poorest performance) to 144 (best performance) and has been normed to a Mean = 100, St Dev = 15.|42 Months|Missing data due to attrition, missed appointments, refusals, or questionable test.|||units on a scale||Standard Deviation|Mean
2574466|NCT02481596|Secondary|Supportive Family Behaviors|as measured by Family and Friend Involvement in Adults' Diabetes (FIAD) helpful involvement subscale ranging from 1= less frequent helpful involvement (worse) to 5=more frequent helpful involvement (better)|3 months, 6 months||||units on a scale||Inter-Quartile Range|Median
2574042|NCT02487771|Primary|Cognitive Function Score - Peabody Picture Vocabulary Test|The Peabody Picture Vocabulary Test, 3rd Edition provides a standardized assessment of a person's receptive vocabulary. The Standard Score can range from 40 (poorest performance) to 160 (best performance) and has been normed to a Mean = 100, St Dev = 15.|60 Months|Missing data due to attrition, missed appointments, refusals, or questionable test.|||units on a scale||Standard Deviation|Mean
2574043|NCT02487771|Primary|Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ|The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.|72 Months|Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.|||units on a scale||Standard Deviation|Mean
2574044|NCT02487771|Primary|Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ|The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.|48 Months|Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.|||units on a scale||Standard Deviation|Mean
2574045|NCT02487771|Primary|Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ|The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.|36 Months|Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.|||units on a scale||Standard Deviation|Mean
2574046|NCT02487498|Secondary|QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point|FEV1 was measured with spirometry conducted according to internationally accepted standards.|Day 1 (5min, 15min, 30 min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time points were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2574047|NCT02487498|Secondary|QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point|FEV1 was measured with spirometry conducted according to internationally accepted standards.|Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time points were included in the analysis|||Liters||Standard Error|Least Squares Mean
2574048|NCT02487498|Secondary|QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Pre-dose trough FEV1 was defined as the average of measurements made 15 minutes and 45 minutes pre morning dose for each treatment.|baseline, 12 weeks|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis|||Liters||Standard Error|Least Squares Mean
2574049|NCT02487498|Secondary|Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 4 hour intervals FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h.|baseline, 12 weeks|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time points were included in the analysis|||Liter||Standard Error|Least Squares Mean
2574050|NCT02487498|Secondary|Change From Baseline in FEV1 AUC 0-12h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 0-12h).|baseline, 0 to 12 hours post-dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis|||Liters||Standard Error|Least Squares Mean
2574051|NCT02487498|Secondary|Change From Baseline in FEV1 AUC 12-24h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 12-24h).|baseline, 12 hours to 24 hours post-dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis|||Liters||Standard Error|Least Squares Mean
2574097|NCT02487030|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: all randomized or enrolled participants who had genotype 4 HCV infection and who took at least 1 dose of study drug.|||percentage of participants||99% Confidence Interval|Number
2574052|NCT02487498|Secondary|Superiority of QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose for each treatment.|baseline, 23 hours 15 minutes and 23 hours 45 minutes post previous morning dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2574053|NCT02487498|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement.|baseline, 0 to 24 hours post-dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and post-baseline time point were included in the analysis|||Liters||Standard Error|Least Squares Mean
2574054|NCT02487498|Primary|Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement.|baseline, 0 to 24 hours post-dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2574055|NCT02487472|Primary|Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits|Evaluation of HZ and PHN related direct and indirect medical costs were done by the drugs prescribed, sick leaves prescribed and medical visits from month 6 to month 9 for the PHN cohort|From Month 6 to Month 9|Analysis was performed on subjects diagnosed with HZ who complied with inclusion criteria & on subjects belonging to PHN sub-cohort from HZ cohort, diagnosed with PHN at 3 months & followed up for 6 more months. This endpoint is presented separately for PHN cohort due to difference in timeframe for HZ cohort (0-3 months),PHN cohort (3-9 months).|||Participants|||Count of Participants
2574056|NCT02487472|Secondary|Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort|"Impact of HZ & PHN on QOL was evaluated using EQ-5D-5L questionnaire,which has 2 parts: EQ-5D-5L descriptive system & EQ Visual analogue scale(EQ-VAS).~EQ-5D-5L descriptive system comprises of 5 dimensions-mobility,self-care,usual activities,pain/discomfort & anxiety/depression.Each dimension has 5 levels:not at all(level 1),mild(level 2),moderate(level 3),severe(level 4),extreme/leading to incapacity(level 5),with highest level corresponding to worst outcome.Subjects had to indicate their health state by choosing the appropriate level from each dimension.The 5 digit health states thus obtained for each dimension were then converted into a single median index value using the EQ-5D-5L crosswalk index value calculator as recommended by EuroQol group.In the EQ-VAS,subjects had to record their health state on a scale ranging from 0(worst imaginable health state) to 100(best imaginable health state).A median of this health state was recorded for subjects analyzed in this outcome measure"|At inclusion (Month 0), Month 1, 3, 6 and 9|Analysis was performed on subjects diagnosed with HZ who complied with inclusion criteria & on subjects belonging to PHN sub-cohort from HZ cohort, diagnosed with PHN at 3 months & followed up for 6 more months. This endpoint is presented separately for PHN cohort due to difference in timeframe for HZ cohort (0-3 months),PHN cohort (3-9 months).|||Quality of life score||Inter-Quartile Range|Median
2574057|NCT02487472|Secondary|Evaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L Questionnarie|"Impact of HZ & PHN on QOL was evaluated using EQ-5D-5L questionnaire,which has 2 parts: EQ-5D-5L descriptive system & EQ Visual analogue scale(EQ-VAS).~EQ-5D-5L descriptive system comprises of 5 dimensions-mobility,self-care,usual activities,pain/discomfort & anxiety/depression.Each dimension has 5 levels:not at all(level 1),mild(level 2),moderate(level 3),severe(level 4),extreme/leading to incapacity(level 5),with highest level corresponding to worst outcome.Subjects had to indicate their health state by choosing the appropriate level from each dimension.The 5 digit health states thus obtained for each dimension were then converted into a single mean index value using the EQ-5D-5L crosswalk index value calculator as recommended by EuroQol group.In the EQ-VAS,subjects had to record their health state on a scale ranging from 0(worst imaginable health state) to 100(best imaginable health state).A mean of this health state was recorded for subjects analyzed in this outcome measure"|At inclusion (Month 0)|The analysis was performed on the subjects who were diagnosed with HZ, complied with inclusion criteria and on subjects belonging to a sub-cohort (PHN cohort) from HZ cohort, diagnosed with PHN at 3 months and followed up for 6 more months.|||Quality of life score||Standard Deviation|Mean
2574058|NCT02487472|Secondary|Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire|HZ and PHN severity was evaluated using 3 categories- mild pain (0<pain<3), moderate pain (3 ≤ pain < 7) and severe pain (7 ≤ pain) for the last 24 hour worst pain.|At inclusion (Month 0), Month 1, 3, 6 and 9|Analysis was performed on subjects diagnosed with HZ who complied with inclusion criteria & on subjects belonging to PHN sub-cohort from HZ cohort, diagnosed with PHN at 3 months & followed up for 6 more months. This endpoint is presented separately for PHN cohort due to difference in timeframe for HZ cohort (0-3 months),PHN cohort (3-9 months).|||Participants|||Count of Participants
2574059|NCT02487472|Secondary|Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire|"HZ and PHN severity was evaluated using 3 categories- mild pain (0<pain<3), moderate pain (3 ≤ pain < 7) and severe pain (7 ≤ pain) for the last 24 hour worst pain.~The Zoster Brief Pain Inventory (ZBPI) questionnaire is a self-administered form to assess HZ pain and burden associated with HZ pain using scales from:~0 for no pain to 10 for the most horrible pain that can be imagined,~0 for no improvement to 100% for full improvement with painkiller,~0 for no burden to 10 for full burden."|At inclusion (Month 0), Month 1 and Month 3|The analysis was performed on the subjects who were diagnosed with HZ, complied with inclusion criteria and on subjects belonging to a sub-cohort (PHN cohort) from HZ cohort, diagnosed with PHN at 3 months and followed up for 6 more months.|||Participants|||Count of Participants
2574060|NCT02487472|Primary|Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits|Evaluation of HZ and PHN related direct and indirect medical costs were done by the drugs prescribed, sick leaves prescribed and medical visits from month 3 to month 6 for the PHN cohort|From Month 3 to Month 6|Analysis was performed on subjects diagnosed with HZ who complied with inclusion criteria & on subjects belonging to PHN sub-cohort from HZ cohort, diagnosed with PHN at 3 months & followed up for 6 more months. This endpoint is presented separately for PHN cohort due to difference in timeframe for HZ cohort (0-3 months),PHN cohort (3-9 months).|||Participants|||Count of Participants
2574061|NCT02487472|Primary|Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits|Evaluation of HZ and PHN related direct medical costs were done by drugs prescribed, sick leaves prescribed, medical visits to a specialist and patient reference to a hospital.|Cumulatively up to Month 3|The analysis was performed on the subjects who were diagnosed with HZ, complied with inclusion criteria and on subjects belonging to a sub-cohort (PHN cohort) from HZ cohort, diagnosed with PHN at 3 months and followed up for 6 more months.|||Participants|||Count of Participants
2574062|NCT02487472|Primary|Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit|Evaluation of HZ and PHN related indirect costs, estimated by direct medical costs were done by the sick leave prescription and medical visit at inclusion. Sick leave prescriptions were defined as an indirect medical cost and medical visits were defined as a direct medical cost.|At Inclusion (Month 0)|The analysis was performed on the subjects who were diagnosed with HZ, complied with inclusion criteria and on subjects belonging to a sub-cohort (PHN cohort) from HZ cohort, diagnosed with PHN at 3 months and followed up for 6 more months.|||Participants|||Count of Participants
2574063|NCT02487472|Primary|Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.|Evaluation of HZ and PHN related direct medical costs were done by the drugs prescribed before and at inclusion. The drugs prescribed were defined as a direct cost.|Before inclusion and at inclusion (Month 0)|The analysis was performed on subjects who were diagnosed with HZ, complied with inclusion criteria and on subjects belonging to a sub-cohort (PHN cohort) from HZ cohort, diagnosed with PHN at 3 months and followed up for 6 more months.|||Participants|||Count of Participants
2574064|NCT02487446|Secondary|QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in Forced Vital Capacity (FVC) at Any Time Point|FEV1 was measured with spirometry conducted according to internationally accepted standards.|Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time points were included in the analysis.|||Liter||Standard Error|Least Squares Mean
2574065|NCT02487446|Secondary|QVA149 Compared to Umeclidinium/Vilanterol in Terms of Change From Baseline in FEV1 at Any Time Point|FEV1 was measured with spirometry conducted according to internationally accepted standards.|Day 1 (5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 23h 15min, 23h 45min); week 6 (-45min, -15min); week 12 (-45min, -15min, 5min, 15min, 30min, hours 1, 2, 4, 8, 11h 55min, 12h 5min, 12h 15min, 12h 30min, 13, 14, 16, 20, 23h 15min, 23h 45min)|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time points were included in the analysis.|||Liter||Standard Error|Least Squares Mean
2574066|NCT02487446|Secondary|Change From Baseline in Pre-dose Trough FEV1 (Mean of 15 Minutes and 45 Minutes Pre Morning Dose)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Pre-dose trough FEV1 was defined as the average of measurements made 15 minutes and 45 minutes pre morning dose for each treatment.|baseline, 15 minutes and 45 minutes pre morning dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis.|||Liter||Standard Error|Least Squares Mean
2574067|NCT02487446|Secondary|Change From Baseline in FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 4 hour intervals FEV1 AUC 0-4h, AUC 4-8h, AUC 8-12h, AUC 12-16h, AUC 16-20h and AUC 20-24h.|baseline, 12 weeks|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time points were included in the analysis.|||Liter||Standard Error|Least Squares Mean
2574068|NCT02487446|Secondary|Change From Baseline in FEV1 AUC 0-12h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 0-12h).|baseline, 0 to 12 hours post-dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis.|||Liter||Standard Error|Least Squares Mean
2574069|NCT02487446|Secondary|Change From Baseline in FEV1 AUC 12-24h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over 12 hours (AUC 12-24h).|baseline, 12 hours to 24 hours post-dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2574098|NCT02486952|Secondary|Percentage of Participants Who Were Alive|Percentage of participants with survival was calculated 41 months after the first dose of study treatment.|Up to 41 months|Full analysis population.|||percentage of participants|||Number
2574467|NCT02481596|Primary|Adherence to Diet - Problem Eating Behavior|as measured by Personal Diabetes Questionnaire diet subscale Problem Eating Behavior (1=less problem eating behavior - better to 6=more problem eating behavior - worse)|3 months, 6 months||||score on a scale||Inter-Quartile Range|Median
2574070|NCT02487446|Secondary|Change From Baseline in Trough FEV1 (Mean of 23h 15 Minutes and 23 h 45 Minutes Post Previous Morning Dose)|FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose for each treatment|baseline, 23 hours 15 minutes and 23 hours 45 minutes post previous morning dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2574071|NCT02487446|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement.|baseline, 0 to 24 hours post-dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and post-baseline time point were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2574072|NCT02487446|Primary|Change From Baseline in Forced Expiratory Volume (FEV1) Area Under the Curve (AUC) 0-24h|FEV1 was measured with spirometry conducted according to internationally accepted standards. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time over an entire day (AUC 0-24h). A positive change from baseline indicates improvement.|baseline, 0 to 24 hours post-dose at week 12|The full analysis, which included all randomized patients who received at least one dose of double-blind treatment, was considered for the analysis. Only participants with a value at both baseline and the post-baseline time point were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2574073|NCT02487303|Secondary|Time Discharge|Time patient meets discharge criteria will be recorded|24 hours postoperative||||hours||Standard Deviation|Mean
2574074|NCT02487303|Secondary|VAS (Visual Analog Scale)|"Visual Analog Scale (VAS) pain assessment with ambulation. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain. For pain intensity, the scale is most commonly anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100‐mm scale]) ."|24 hours||||units on a scale||Standard Error|Mean
2574075|NCT02487303|Secondary|Time to First Opiate Rescue|Time to first opiate pain medicine requested by patient|48 hours||||hours||Standard Error|Mean
2574076|NCT02487303|Primary|Cumulative Postoperative Opiate Consumption|Cumulative opiate consumption (IV morphine equivalents)|24 hours||||mg||Full Range|Mean
2574077|NCT02487277|Secondary|Disease Free Survival (DFS)|Kaplan-Meier methods will be used to analyze disease free survival and median time and 95% confidence intervals will be reported|Up to 5 years|No data was collected for these patients.||||||
2574078|NCT02487277|Secondary|Overall Response Rate (ORR)|Descriptive statistics with frequency and proportion of overall response determined by CA 19-9 levels will be checked every 4 weeks and restaging CT/MRI of the chest, abdomen and pelvis will be obtained every 8 weeks|Up to 5 years|No data was collected for these patients.||||||
2574079|NCT02487277|Secondary|Margin-Negative (R0) Resection Rate|Patients will be evaluated for surgical resection depending on imaging obtained on Cycle 4 Day 21. R0 Resection rate determined by CA 19-9 levels will be checked every 4 weeks and restaging CT/MRI of the chest, abdomen and pelvis will be obtained every 8 weeks surgical resection if the patient's tumor is deemed resectable post-therapy. Patients who have received at least 2 complete, 28-day cycles of study drugs were included in the secondary analyses|Up to 5 years|No data was collected for these patients.||||||
2574080|NCT02487277|Secondary|Percent Change of CA19-9 Response Rate|To evaluate the disease response to treatment, CA19-9 levels will be measured every 4 weeks and restaging Computerized tomography (CT) / magnetic resonance imaging (MRI)of the chest, abdomen and pelvis will be obtained every 8 weeks|Up to 5 years|No data was collected for this endpoint||||||
2574081|NCT02487277|Primary|Rate of Pathologic Complete Response (pCR)|Descriptive statistics with frequency / proportion will be used to evaluate rate of pathologic complete response using the pathological exam of resected tumors. pCR was defined as area of scarring in pancreatic parenchyma and/or peripancreatic soft tissue with chronic inflammation, with or without acellular mucin pools and histiocytic infiltrates, but no residual viable invasive adenocarcinoma cells in the pancreatectomy specimen|Up to 5 years|No data was collected for these patients.||||||
2574082|NCT02487277|Primary|Incidence of Clinically Relevant Pancreatic Fistula|Our study will be investigating only clinically relevant pancreatic fistulas, i.e. grades B or C. Descriptive statistics will be used report the incidence of pancreatic fistula within the 7-day post-operative period after neoadjuvant treatment|Up to 5 years|No data was collected for these patients.||||||
2574083|NCT02487225|Primary|Change in Interleukin-8 (IL-8) Levels From Admission Baseline at One Week.|IL-8 is a chemotactic factor that attracts neutrophils, basophils, and T-cells, but not monocytes. It is also involved in neutrophil activation. It is released from several cell types in response to an inflammatory stimulus. Units: pg/mL|Admission (baseline), day 5|Eighteen (18) of forty-five subjects (45) in the treatment arm and eight (8) of thirty-eight (38) subjects in the placebo arm completed the study. Additionally, subjects had blood collections for 5 days or until dismissal. Many subjects were dismissed at 2-3 days.|||pg/ml||Standard Deviation|Mean
2574099|NCT02486952|Primary|Probability of Event Free Survival (EFS)|EFS was calculated as the time from randomization to the date of first reported event. Events were defined as disease progression or relapse, institution of a new anticancer treatment, or death from any cause without progression.|Up to 41 months|Full analysis population.|||probability of EFS||95% Confidence Interval|Number
2574100|NCT02486939|Secondary|DAS28-CRP(4) <2.6 (ie, Remission) on All Visits After DAS28-CRP(4) <2.6 Was Achieved for Subjects With RA.|"The DAS28-CRP(4) is a composite score (ranging from 0 to 9.4) calculated using the results of the TJC (using a 28 joint subset), SJC (using a 28 joint subset), hs-CRP level (mg/L), and SGA (0 to 100 scale). The DAS28-CRP(4) was calculated using the following formula:0.56*sqrt(28TJC) + 0.28*sqrt(28SJC) + 0.36*ln(CRP+1) + 0.014* SGA + 0.96.~For DAS28-CRP(4), scores indicating high disease activity are >5.1; low disease activity are <3.2;and remission are <2.6."|48 Weeks||||Participants|||Count of Participants
2574084|NCT02487225|Primary|Change in Interleukin-6 (IL-6) Levels From Admission Baseline at One Week.|Interleukin-6 (IL-6) may be used to help evaluate a person who has a condition associated with inflammation, such as lupus or rheumatoid arthritis, or with infection, such as sepsis. It may also be used in the evaluation of diabetes or cardiovascular disease. IL-6 is a cytokine, a protein produced by immune cells that acts on other cells to help regulate and/or promote an immune response. It also stimulates the production of acute phase reactants, proteins that increase in the blood with conditions that cause inflammation or tissue injury. Circulating IL-6 can be found in the blood of normal individuals in the 1 pg/mL range, with slight elevations during the menstrual cycle, modest elevations in certain cancers (melanoma) (10 pg/mL), and large elevations after surgery (30-430 pg/mL).Units: pg/ml|Admission (baseline), day 5|Eighteen (18) of forty-five subjects (45) in the treatment arm and eight (8) of thirty-eight (38) subjects in the placebo arm completed the study. Additionally, subjects had blood collections for 5 days or until dismissal. Many subjects were dismissed at 2-3 days.|||pg/mL||Standard Deviation|Mean
2574085|NCT02487225|Primary|Change in Tumor Necrosis Factor-alpha (TNF-a) Levels From Admission Baseline at One Week.|Tumor Necrosis Factor Alpha is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. TNF is important to the body because it helps regulate the response of the immune system to a foreign object, especially to the present cancerous tumor. It promotes inflammation, produces other cells used in the inflammatory response, and can help cells heal. The normal range is 5 to 27.2 pg/ml.Units: pg/ml|Admission (baseline), day 5|Eighteen (18) of forty-five subjects (45) in the treatment arm and eight (8) of thirty-eight (38) subjects in the placebo arm completed the study. Additionally, subjects had blood collections for 5 days or until dismissal. Many subjects were dismissed at 2-3 days.|||pg/ml||Standard Deviation|Mean
2574086|NCT02487225|Primary|Change in C-reactive Protein (C-RP) From Admission Baseline at One Week.|C-reactive protein is a substance produced by the liver in response to inflammation. Normal C-RP levels are below 3.0 mg/L.Units: mg/L|Admission (baseline), day 5|Eighteen (18) of forty-five subjects (45) in the treatment arm and eight (8) of thirty-eight (38) subjects in the placebo arm completed the study. Additionally, subjects had blood collections for 5 days or until dismissal. Many subjects were dismissed at 2-3 days.|||mg/L||Standard Deviation|Mean
2574087|NCT02487199|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
2574088|NCT02487199|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment or confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment with at least 6 weeks of treatment.|12 weeks||||percentage of participants||95% Confidence Interval|Number
2574089|NCT02487199|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity from first dose of study drug until 30 days after the last dose. For more details on AEs please see the Adverse Event section.|Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks)|Safety population: All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2574090|NCT02487199|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug. Participants with missing data after backward imputation were imputed as nonresponders.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2574091|NCT02487056|Secondary|Mortality|All cause death|1 month||||Participants|||Count of Participants
2574092|NCT02487056|Secondary|Length of Hospitalisation|Length of stay in hospital in Turkish population admitted to study|In-Hospital||||Day||Full Range|Median
2574093|NCT02487056|Primary|Adherence to European Heart Failure Guideline|To assess number of patients managed and treated following the last European Heart Failure Guidelines|Admission to Hospital (Enrollment)||||Participants|||Count of Participants
2574094|NCT02487030|Secondary|Percentage of Participants With Overall Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure~confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),~confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound),~HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse)~Relapse~HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2574095|NCT02487030|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ 4 and 24 weeks after the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2574096|NCT02487030|Primary|Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE)||12 weeks|Safety analysis Set|||percentage of participants|||Number
2574101|NCT02486939|Secondary|Disease Activity Score Using 28 Tender and Swollen Joint Counts, High Sensitivity C-reactive Protein, and Subject's Global Assessment of Disease Activity (DAS28-CRP[4]) <3.2 (ie, Low Disease Activity) at All Visits for All Subjects With RA.|The DAS28-CRP(4) is a composite score (ranging from 0 to 9.4) calculated using the results of the TJC (using a 28 joint subset), SJC (using a 28 joint subset), hs-CRP level (mg/L), and SGA (0 to 100 scale). The DAS28-CRP(4) was calculated using the following formula:0.56*sqrt(28TJC) + 0.28*sqrt(28SJC) + 0.36*ln(CRP+1) + 0.014* SGA + 0.96. For DAS28-CRP(4), scores indicating high disease activity are >5.1; low disease activity are <3.2;and remission are <2.6.|108 Weeks||||participants|||Number
2574102|NCT02486939|Primary|In Subjects With PsO, Durability of Response (Maintenance of PASI-50 Response or Greater), Which Was Measured at Each Visit.|All PASI score assessors must have demonstrated proficiency at performing the PASI. Every attempt was made to use the same assessor for each subject throughout the study. n subjects with PsO, durability of response (maintenance of a PASI-50 response or greater at each assessment) was based on scoring the PsO lesions on a scale of 0 to 4 for 3 characteristics: erythema, induration, and desquamation, and within 4 anatomical regions: head, trunk, upper extremities, and lower extremities. Within each of these regions, the area of involvement was scored on a scale of 0 to 6, with the total score being a weighted average, and weights defined by the area of involvement. The clinician assessed the subject's PsO lesions according to the PASI and provided this score within the case report form at Weeks 0 (as the Week 48 assessment of the parent study), 4, 12, 24, 36, and 48. Subjects were classified as having a PASI-50 response based upon 50% reduction from baseline of the parent study.|Week 0,4,12,24,36,48||||Participants|||Count of Participants
2574103|NCT02486939|Primary|Durability of Response (Maintenance of an ACR20 Response or Greater), Which Was Measured at Each Visit in Subjects of RA|"The ACR20 is a composite endpoint based on the following assessments: 66/68 swollen joint count (SJC) or tender joint count (TJC), Subject's pain assessment (SPA)-visual analog scale (VAS),Subject's global assessment of disease activity (SGA)-VAS,Physician's global assessment of disease activity (PGA)-VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and High sensitivity C-reactive protein (hs-CRP).The baseline value to assess the ACR20 during this study was the same baseline value used to assess the ACR20 during the parent study (ie, the Week 0 assessment in the parent study).~Subjects were considered an ACR20 responder at a visit if compared to baseline in the parent study (CHS-0214-02) they achieved: At least 20% decrease in SJC, At least 20% decrease in TJC, and At least 20% improvement in at least 3 of the following 5 measures: C-reactive protein, HAQ-DI, SPA (using a VAS) for pain,SGA (using a VAS), orPGA (using a VAS)."|48 Weeks||||Participants|||Count of Participants
2574104|NCT02486796|Secondary|Sedimentation Rate of Erythrocytes in Blood (mm/hr)|The erythrocyte sedimentation rate will be measured by approved methods.|Initial visit and study visits at 3-week intervals up to 4 months|Sedimentation rate was not determined for one subject in the 'Immediate' Arm at Visit 1, one subject in the 'Delayed' Arm at Visit 2 and one subject in the 'Immediate' Arm at Visit 3 due to blood sample not collected. One subject in each arm withdrew consent after visits 2 and 4, respectively.|||mm/hr||Standard Deviation|Mean
2574105|NCT02486796|Secondary|Concentration of Circulating Tumor Cells in Blood (Cells Per Milliliter)|The serum concentration of circulating tumor cells will be measured by approved methods.|Initial visit and study visits at 3-week intervals up to 4 months|Circulating tumor cells were not determined for one subject in the 'Immediate' Arm at Visit 1, one subject in the 'Delayed' Arm at Visit 2 and one subject in the 'Immediate' Arm at Visit 3 due to blood sample not collected. One subject in each arm withdrew consent after visits 2 and 4, respectively.|||cells/ml||Standard Deviation|Mean
2574106|NCT02486796|Secondary|Concentration of C-reactive Protein in Serum (mg/L)|The serum concentration of C-reactive protein will be measured by approved methods.|Initial visit and study visits at 3-week intervals up to 4 months|C-reactive protein was not determined for one subject in the 'Immediate' Arm at Visit 1, one subject in the 'Delayed' Arm at Visit 2 and one subject in the 'Immediate' Arm at Visit 3 due to blood sample not collected. One subject in each arm withdrew consent after visits 2 and 4, respectively.|||mg/dl||Standard Deviation|Mean
2574107|NCT02486796|Primary|Subject Reported Quality of Life Score|Subject quality of life as measured by a self-administered questionnaire (0 to 10 Likert scale with 0=No Effect to 10=Worst Effect) at each study visit. The symptoms or impact on activities scored included: Pain, Fatigue, Nausea, Sleep Disturbance, Distress, Shortness of Breath, Memory/Recall Problems, Appetite, Drowsiness, Dry Mouth, Sadness, Vomiting, Numbness, General Activities, Mood, Work, Relationships, Walking or Enjoyment.|Initial visit and study visits at 3-week intervals up to 4 months|One subject in the 'Delayed' arm withdrew consent following Study Visit 2. One subject in the 'Immediate' arm did not complete the Quality of Life Questionnaire at Visit 2. One subject in the 'Delayed' arm did not complete the Quality of Life Questionnaire at Visit 5. One subject in the 'Immediate' Arm withdrew consent prior to completing Visit 5.|||units on a scale||Standard Deviation|Mean
2574108|NCT02486757|Primary|Ovulation in Cycle 2|serum progesterone > 3 ng/ml or presence of corpus luteum on pelvic ultrasound|20-40 days|subjects with sufficient data in cycle to determine ovulatory/anovulatory status|||Participants|||Count of Participants
2574109|NCT02486692|Primary|PTSD Treatment Initiators|percentage/rate of PTSD treatment initiation at post assessment (2-weeks) Phase I participants did not participate in Phase II (the clinical trial portion of the study) and were not assessed using this measure.|two weeks post assessment|Total N=60; Only 49 randomized (26 in EXP arm and 23 in Usual Care arm) because 11 participants did not access the website portal to obtain their randomization assignment. Data was also missing for 1 participant at post.|||Participants|||Count of Participants
2574110|NCT02486692|Primary|PTSD Checklist (PCL-V)|"The PCL-V is a 20-item self-report measure that assesses PTSD severity. Individual item responses can range from 0-4 with 0 being Not At All and 4 being Extremely and total scores can range from 0 to 80. Higher numbers on the PCL-V are indicative of greater PTSD severity.~Phase I participants did not participate in Phase II (the clinical trial portion of the study) and were not assessed using this measure."|pre-treatment (baseline) & post-treatment (2-week) assessment|Total N=60; Only 49 randomized (26 in EXP arm and 23 in Usual Care arm) because 11 participants did not access the website portal to obtain their randomization assignment.|||units on a scale||Standard Deviation|Mean
2574468|NCT02481596|Primary|Adherence to Exercise|as measured by International Physical Activity Questionnaire-Short form [metabolic equivalent minutes (MET-minutes) per week] where more MET-minutes per week indicates more physical activity|3 months, 6 months||||MET-minutes per week||Inter-Quartile Range|Median
2574111|NCT02486692|Primary|Endorsed and Anticipated Stigma Inventory (EASI)|"THE EASI assesses for perceptions of treatment effectiveness, stigma, and external barriers to treatment seeking. Answers are ranked from 1 to 5 with 1 being Strongly Disagree and 5 being Strongly Agree and higher scores are indicative of greater stigma. Total scores can range from 40 to 190.~Phase I participants did not participate in Phase II (the clinical trial portion of the study) and were not assessed using this measure."|pre-treatment (baseline) & post-treatment (two-week) assessment|Total N=60; Only 49 randomized (26 in EXP arm and 23 in Usual Care arm) because 11 participants did not access website portal to obtain their randomization assignment. The EASI was also missing for 1 participant at post.|||units on a scale||Standard Deviation|Mean
2574112|NCT02486653|Secondary|Number of Participants Who Experienced Adverse Events|Adverse events, systematically collected. Summary results reported here, please refer to Adverse Events section of the results record for detailed reporting.|treatment day 1 (7 days before surgery) until 30 days after surgery||||Participants|||Count of Participants
2574113|NCT02486653|Secondary|Hospital Length of Stay in Days|Collected after the participant is discharged from the hospital, total number of consecutive days (including day of surgery) until the participant is discharged from the hospital|up to 30 days after surgery||||days||Standard Deviation|Mean
2574114|NCT02486653|Secondary|Urinary Tract Infection (UTI)|Either a culture-positive UTI prior to discharge from the hospital or subject self-reported clinician-diagnosed UTI occurring within 30 days of surgery|up to 30 days after surgery|This participant did not have urinary retention; self-reported UTI, catheter was removed on post operative day #2|||Participants|||Count of Participants
2574115|NCT02486653|Secondary|Discharge From Hospital With Indwelling Urinary Catheter|Does the subject have a urinary catheter in place at the time of discharge from the hospital? This is a binary outcome measure of whether or not the subject is discharged from the hospital with an indwelling urinary catheter in place due to inadequate voiding function.|up to 30 days after surgery||||Participants|||Count of Participants
2574116|NCT02486653|Secondary|First Post-void Residual Urine Volume|The post-void residual (PVR) urine volume as measured by bedside hand-held bladder scanning immediately following the first spontaneous void|within 0-7 days after surgery|Only includes subjects who were NOT straight-catheterized AND there were 20 additional subjects for which PVR was not recorded|||mL||Standard Deviation|Mean
2574117|NCT02486653|Secondary|Total Number of Intermittent Catheterizations Required Per Subject|total number of intermittent catheterizations required, as dictated by the institutional bladder management protocol|within 0-7 days after surgery||||Participants|||Count of Participants
2574118|NCT02486653|Secondary|Time Until First Spontaneous Void|time from IUC removal, last intermittent catheterization (if performed in the operating room or post-anesthesia care unit), or departure from the operating room (if no IUC placed intraoperatively) until first spontaneous void|within 0-7 days after surgery|Time to first spontaneous void was not collected as this is not relevant clinically to diagnosis of urinary retention, and our bladder management protocol prevents unbiased collection of this data point.||||||
2574119|NCT02486653|Secondary|Need for Replacement of Indwelling Urinary Catheter as a Binary Outcome|Need for replacement of an IUC after surgery or after initial removal of an IUC that was placed at the time of surgery; replacement of IUC is dictated by the institutional bladder management protocol after requiring the use of straight catheterization for 24 hours|within 0-7 days after surgery||||Participants|||Count of Participants
2574120|NCT02486653|Primary|Need for Any Intermittent Catheterization Postoperatively as a Binary Outcome|need for any intermittent catheterization after leaving the operating room or after initial indwelling urinary catheter (IUC) removal; subjects will be straight catheterized if the subject either 1) reports bladder discomfort, or 2) has a bladder scan for >500milliliters; or 3) has a post-void residual volume >500milliliters|within 0-7 days after surgery|This is an intent-to-treat analysis, including all subjects who were randomized and did not withdraw prior to the intended start date of their study drug.|||Participants|||Count of Participants
2574121|NCT02486627|Secondary|Plasma PK: Minimum Observed Plasma Drug Concentration (Cmin)|PK blood samples were collected on Day 3 (plus or minus 1 day) of study drug administration for the determination of plazomicin concentrations in plazomicin-treated patients.|Day 3|The PK Population included patients who received at least one dose of plazomicin and had at least one quantifiable plazomicin plasma concentration available for analysis.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
2574122|NCT02486627|Secondary|Plasma PK: Maximum Observed Plasma Drug Concentration (Cmax)|PK blood samples were collected on Day 3 (plus or minus 1 day) of study drug administration for the determination of plazomicin concentrations in plazomicin-treated patients.|Day 3|The PK Population included patients who received at least one dose of plazomicin and had at least one quantifiable plazomicin plasma concentration available for analysis.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
2574123|NCT02486627|Secondary|Plasma Pharmacokinetics (PK): Area Under the Curve From 0 to 24 Hours (AUC 0-24h)|PK blood samples were collected on Day 3 (plus or minus 1 day) of study drug administration for the determination of plazomicin concentrations in plazomicin-treated patients.|Day 3|The PK Population included patients who received at least one dose of plazomicin and had at least one quantifiable plazomicin plasma concentration available for analysis.|||mg*h/L (milligrams times hour per liter)||Geometric Coefficient of Variation|Geometric Mean
2574124|NCT02486627|Secondary|Percentage of Patients With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered to be drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and it does not imply any judgment about causality. Adverse events also include the exacerbation or worsening of a condition present at screening other than the index infection for which the patient was enrolled in the study. A TEAE is any AE that newly appeared, increased in frequency, or worsened in severity following initiation of study drug.|Up to Day 32|The safety population included all randomized patients who received any amount of study drug.|||percentage of patients|||Number
2574469|NCT02481596|Primary|Adherence to Diet - Use of Dietary Information|as measured by Personal Diabetes Questionnaire Use of Dietary Information for Decision Making (1=less use of information - worse to 6=more use of information - better)|3 months, 6 months||||score on a scale||Inter-Quartile Range|Median
2574125|NCT02486627|Secondary|Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the ME Population at TOC|Microbiological eradication: urine culture showed the pathogen found at baseline at ≥10^5 CFU/mL was reduced to <10^4 CFU/mL. Clinical Cure TOC: Complete resolution or return to premorbid levels of core symptoms of cUTI and no new symptoms develop, and no use of non-study antibiotic therapy for the current cUTI. Failure TOC: Persistence of one or more core symptom of infection or reappearance of or development of new core symptoms that require alternative non-study antibiotic therapy for the current cUTI.|Day 17 TOC Visit|The ME (TOC) population consists of clinically evaluable patients with interpretable culture results at TOC, defined as one that has clearly identified pathogen(s) or one where baseline pathogen(s) could be excluded.|||percentage of patients|||Number
2574126|NCT02486627|Secondary|Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the ME Population at Day 5|Microbiological eradication: urine culture showed the pathogen found at baseline at ≥10^5 CFU/mL was reduced to <10^4 CFU/mL. Clinical Cure Day 5: Marked improvement defined as complete resolution or return to premorbid levels or reduction in severity of all core baseline symptoms with worsening of none, and no new symptoms develop. Failure Day 5: Lack of improvement in core baseline symptoms of cUTI or development of new core symptoms of cUTI; AE requiring the discontinuation of study drug and the patient required alternative non-study antibiotic therapy for the current cUTI.|Day 5|The ME (Day 5) population consists of clinically evaluable patients with interpretable culture results at Day 5, defined as one that has clearly identified pathogen(s) or one where baseline pathogen(s) could be excluded.|||percentage of patients|||Number
2574127|NCT02486627|Primary|Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the mMITT Population at Test of Cure (TOC)|Microbiological eradication was defined as a urine culture that showed the pathogen found at baseline at ≥10^5 CFU/mL was reduced to <10^4 CFU/mL. Clinical Cure at TOC Visit: the complete resolution or return to premorbid levels of core symptoms of cUTI and no new symptoms develop, and no use of non-study antibiotic therapy for the current cUTI. Failure: Persistence of one or more core symptom of infection or reappearance of or development of new core symptoms that require alternative non-study antibiotic therapy for the current cUTI. Indeterminate: Insufficient data are available to allow an evaluation of clinical outcome for any reason.|Day 17 TOC Visit|The mMITT Population consisted of all patients in the ITT Population who received any amount of study drug and had at least one qualified baseline pathogen from a study qualifying baseline urine culture against which meropenem and plazomicin have antibacterial activity.|||percentage of patients|||Number
2574128|NCT02486627|Primary|Percentage of Patients With Composite of Microbiological Eradication and Clinical Cure in the Microbiological Modified ITT (mMITT) Population at Day 5|Microbiological eradication was defined as a urine culture that showed the pathogen found at baseline at ≥10^5 colony forming units per milliliter (CFU/mL) was reduced to <10^4 CFU/mL. Clinical Cure at Day 5: marked improvement evidenced by complete resolution or return to premorbid levels or reduction in severity of all core baseline symptoms with worsening of none, and no new symptoms developed. Failure: Lack of improvement in core baseline symptoms of cUTI or development of new core symptoms of cUTI; adverse event (AE) requiring the discontinuation of study drug and the patient required alternative non-study antibiotic therapy for the current cUTI. Indeterminate: Insufficient data are available to allow an evaluation of clinical outcome for any reason.|Day 5|The mMITT Population consisted of all patients in the ITT Population who received any amount of study drug and had at least one qualified baseline pathogen from a study qualifying baseline urine culture against which meropenem and plazomicin have antibacterial activity.|||percentage of patients|||Number
2574129|NCT02486302|Other Pre-specified|Number of Participants With Rheumatoid Arthritis (RA) Achieving 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Weeks 36 and 52|DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. Participants who had DAS28 <= 2.6 were considered in remission.|Weeks 36, 52|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA. “Number analyzed” signifies participants analyzed for this outcome measure at specified time points.|||Participants|||Count of Participants
2574130|NCT02486302|Other Pre-specified|"Number of Participants With Plaque Psoriasis (PsO) Achieving PASI75 Score or a PGA of Clear or Almost Clear And DLQI Total Score of 0 or 1 at Weeks 36 and 52"|PASI:combined assessment of lesion severity & area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) & severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear & almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).|Weeks 36, 52|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. “Number analyzed” signifies participants analyzed for this outcome measure at specified time points.|||Participants|||Count of Participants
2574148|NCT02486302|Secondary|Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52|BASDAI is a validated self-assessment tool used to determine disease activity in participant with ankylosing spondylitis. Utilizing a VAS of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score averages the individual assessments for a final score range of 0(no symptoms)-10(very severe symptoms).|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||units on a scale||Standard Deviation|Mean
2574131|NCT02486302|Other Pre-specified|Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than < 2.6 or Meet Minimal Disease Activity (MDA) Criteria at Weeks 36 and 52|DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC <=1; 2) SJC =<1; 3) PASI <= 1 or body surface area (BSA) <=3; 4) Participant pain on VAS <= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain [best] and 100 mm = maximum possible pain [worst]; 5) PtGA on VAS <= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) <= 0.5(HAQ=3.16-[0.028* hannover functional questionnaire [FFbH]); 7) Tender enthesial points <= 1.|Weeks 36, 52|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA. “Number analyzed” signifies participants analyzed for this outcome measure at specified time points.|||Participants|||Count of Participants
2574132|NCT02486302|Other Pre-specified|Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than < 1.3 at Weeks 36 and 52|ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 <= ASDAS < 1.3; moderate disease activity: 1.3 <= ASDAS < 2.1; high disease activity: 2.1 <= ASDAS <= 3.5; very high disease activity: 3.5 < ASDAS.|Weeks 36, 52|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA. “Number analyzed” signifies participants analyzed for this outcome measure at specified time points.|||Participants|||Count of Participants
2574133|NCT02486302|Other Pre-specified|Number of Participants With Positive Human Leukocyte Antigen B27(HLA-B27) at Baseline for Participants With Axial Spondyloarthritis(axSpA)|Participants with Axial Spondyloarthritis with Positive Human Leukocyte Antigen (HLA-B27) were reported.|Baseline|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA.|||Participants|||Count of Participants
2574134|NCT02486302|Other Pre-specified|Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies at Weeks 12, 24, 36 and 52|To assess the pharmacodynamics effect of etanercept on serum levels of autoantibodies, Anti-CCP antibodies levels were measured.|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA, AxS or PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||unit per milliliter (U/mL)||Standard Deviation|Mean
2574135|NCT02486302|Other Pre-specified|Number of Participants With Rheumatoid Factor (RF) at Weeks 12, 24, 36 and 52|RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA, axSpA or PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||Participants|||Count of Participants
2574136|NCT02486302|Other Pre-specified|C-Reactive Protein (CRP) Levels at Weeks 12, 24, 36 and 52|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||mg/L||Standard Deviation|Mean
2574137|NCT02486302|Other Pre-specified|Erythrocyte Sedimentation Rate (ESR) at Weeks 12, 24, 36 and 52|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. 'Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||mm/hr||Standard Deviation|Mean
2574138|NCT02486302|Secondary|Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52|"Participant's assessment of pruritus measured on a 100 mm VAS ranging from 0 as no Pruritus to 100 as most severe pruritus."|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||units on a scale||Standard Deviation|Mean
2574139|NCT02486302|Secondary|Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52|The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): no effect at DLQI < 2; small effect at 2 <=DLQI <= 5; moderate effect at 6 <=DLQI <= 10; very large effect at 11<=DLQI <= 20; extremely large effect at 21 <= DLQI <= 30.|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||units on a scale||Standard Deviation|Mean
2574140|NCT02486302|Secondary|Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO)|PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) & severity estimated by clinical signs of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. Number analyzed signifies participants analyzed for this outcome measure at specified categories."|||units on a scale||Standard Deviation|Mean
2574141|NCT02486302|Secondary|Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO)|PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) & severity estimated by component score of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. Number analyzed signifies participants analyzed for this outcome measure at specified categories."|||units on a scale||Standard Deviation|Mean
2574142|NCT02486302|Secondary|Median Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response in Participants With Plaque Psoriasis (PsO)|PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%) - 6(90-100%) & severity estimated by clinical signs of erythema, induration, desquamation; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI75: at least a 75 % reduction in PASI relative to Baseline.|Baseline up to Week 24|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO.|||days||Standard Deviation|Median
2574143|NCT02486302|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% involvement to 6= 90-100% involvement. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.|Baseline, Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||units on a scale||Standard Deviation|Mean
2574144|NCT02486302|Secondary|Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52|Each of the 10 fingers and 10 toes was evaluated for dactylitis. Score ranged from 0 to 20, where affected numbers of fingers and toes were evaluated.|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||finger or toes||Standard Deviation|Mean
2574145|NCT02486302|Secondary|Mean Percentage of Total Body Surface Area (BSA) for Participants With Plaque Psoriasis (PsO) and Psoriasis Arthritis (PsA) at Weeks 12, 24, 36 and 52|Percentage of BSA affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected.|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO, PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||percentage of BSA||Standard Deviation|Mean
2574146|NCT02486302|Secondary|Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52|Occiput-to-wall distance was the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||cm||Standard Deviation|Mean
2574147|NCT02486302|Secondary|Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52|An enthesis is the site where the joint capsules, ligaments or tendons attach to the bone. Enthesitis is the inflammation of the entheses. This inflammation can lead to severe pain and discomfort.|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA or PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||enthesis||Standard Deviation|Mean
2574149|NCT02486302|Secondary|Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity, and C-reactive protein (CRP) (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||units on a scale||Standard Deviation|Mean
2574150|NCT02486302|Secondary|Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||units on a scale||Standard Deviation|Mean
2574151|NCT02486302|Secondary|Hannover Functional Questionnaire (FFbH) Functional Capacity Score of Participants With Rheumatoid Arthritis (RA), Axial Spondyloarthritis (axSpA), Psoriasis Arthritis (PsA) at Weeks 12, 24, 36, 52|"FFbH consisted 18 questions to assess daily activities in last 7 days. Each question was answered by the participant as Yes, I can perform the activity without difficulty (score assigned = 2), Yes, but with some difficulties (score assigned = 1) and No or only with help (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicated better daily activities."|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA, axSpA or PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||units on a scale||Standard Deviation|Mean
2574152|NCT02486302|Secondary|Number of Participants Who Switched to Other Therapy After Treatment Discontinuation|Participants who switched from etanercept to either disease-modifying antirheumatic drugs (DMARDs) or alternative biologic drug were reported.|Baseline up to Week 52|Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented. Overall number of participants analyzed signifies participants from treated set who discontinued treatment with Etanercept.|||Participants|||Count of Participants
2574153|NCT02486302|Secondary|Percentage of Participants Who Discontinued Treatment Due to Lack of Efficacy or Adverse Events|Percentage of participants who discontinued etanercept before completing the study, was reported.|Baseline up to Week 52|Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented.|||percentage of participants|||Number
2574154|NCT02486302|Secondary|Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52|"FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as Yes, I can perform the activity without difficulty (score assigned = 2), Yes, but with some difficulties (score assigned = 1) and No or only with help (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded)."|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||spearman correlation coefficient||95% Confidence Interval|Number
2574155|NCT02486302|Secondary|Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52|"FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as Yes, I can perform the activity without difficulty (score assigned = 2), Yes, but with some difficulties (score assigned = 1) and No or only with help (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded)."|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||spearman correlation coefficient||95% Confidence Interval|Number
2574169|NCT02486302|Secondary|Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set||Baseline up to Weeks 12, 24, 36, 52|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation.|||percentage of participants|||Number
2574156|NCT02486302|Secondary|Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52|"FFbH consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as Yes, I can perform the activity without difficulty (score assigned = 2), Yes, but with some difficulties (score assigned = 1) and No or only with help (score assigned = 0). Final FFbH score (FFbH functional capacity) was then computed according to formula: (Sum of all single scores * 100% [percent]) / (2 * number of answered questions) ranged between 0-100; higher score indicates better daily activities. Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes [24 hours*60 minutes] was recorded)."|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||spearman correlation coefficient||95% Confidence Interval|Number
2574157|NCT02486302|Secondary|Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52|"The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 (not at all) to 3 (nearly every day). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported."|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||spearman correlation coefficient||95% Confidence Interval|Number
2574158|NCT02486302|Secondary|Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52|"The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 (not at all) to 3 (nearly every day). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported."|Weeks 12, 24, 36, 52|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA. Number analyzed signifies participants analyzed for this outcome measure at specified time points.|||spearman correlation coefficient||95% Confidence Interval|Number
2574159|NCT02486302|Secondary|Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52|"The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 (not at all) to 3 (nearly every day). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported."|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||spearman correlation coefficient||95% Confidence Interval|Number
2574170|NCT02486302|Secondary|Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS)||Baseline up to Weeks 12, 24, 36, 52|Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented.|||percentage of participants|||Number
2574177|NCT02486302|Primary|Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 and Maintained Till 52 Weeks|DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR [mm/h] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Week 24 up to Week 52|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure.|||Participants|||Count of Participants
2574160|NCT02486302|Secondary|Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52|"The PtGA of disease activity was measured on a VAS ranged from 0 mm to 100 mm, where 0 = no disease activity and 100=high disease activity. Participants assessed their fatigue during the last 7 days using a 0 mm - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. Participants assessed pain using a 0 mm - 100 mm VAS where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst). The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia over the past 2 weeks, scoring each question on scale of 0 (not at all) to 3 (nearly every day). Total PHQ-2 ranged from 0-6. PGA disease activity was measured on a 0 mm to 100 mm VAS, with 0 mm = no disease activity and 100mm = maximum possible disease activity. Correlation coefficient between each of these parameters was measured using spearman correlation coefficient and reported."|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||spearman correlation coefficient||95% Confidence Interval|Number
2574161|NCT02486302|Secondary|Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52|"The PHQ-2 is a brief depression screening instrument and enquire two factors: frequency of depressed mood and anhedonia (inability to feel pleasure in normally pleasurable activities) over the past 2 weeks, scoring each question on scale of 0 (not at all) to 3 (nearly every day). Total PHQ-2 score ranged from 0-6 (0 indicate not at all: depression/anhedonia can be ruled out; 6 indicate nearly every day: worsening of depression/anhedonia)."|Weeks 12, 24, 36, 52|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome at specified time points.|||units on a scale||Standard Deviation|Mean
2574162|NCT02486302|Secondary|Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52|PGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity; 100 mm= high disease activity.|Weeks 12, 24, 36, 52|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome at specified time points.|||mm||Standard Deviation|Mean
2574163|NCT02486302|Secondary|Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52|Participants assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain (best) and 100 mm = maximum possible pain (worst).|Weeks 12, 24, 36, 52|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome at specified time points.|||mm||Standard Deviation|Mean
2574164|NCT02486302|Secondary|Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52|Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|Weeks 12, 24, 36, 52|"PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Number analyzed signifies participants analyzed for this outcome measure at specified time points."|||mm||Standard Deviation|Mean
2574165|NCT02486302|Secondary|Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52|"Participants answered question: How do you assess your current disease activity? Participants responded by using a 0 - 100 mm visual analog scale where 0 mm = no activity and 100 mm = highest possible activity."|Weeks 12, 24, 36, 52|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. “Number analyzed” signifies participants analyzed for this outcome measure at specified time points.|||mm||Standard Deviation|Mean
2574166|NCT02486302|Secondary|Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52|DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. Participants who had DAS28 <= 2.6 were considered in remission.|Weeks 12, 24, 36, 52|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA or PsA. “Number analyzed” signifies participants analyzed for this outcome measure at specified time points.|||Participants|||Count of Participants
2574167|NCT02486302|Secondary|Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.|Baseline up to Weeks 12, 24, 36, 52|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation.|||Participants|||Count of Participants
2574168|NCT02486302|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were measured up to Week 12, 24, 36 and 52 of exposure with study drug that were absent before treatment or that worsened relative to pretreatment state. TEAEs included both SAEs and non-SAEs.|Baseline up to Weeks 12, 24, 36, 52|Treated set included all documented participants who were treated, had at least 1 post-baseline value and had an AE documented.|||Participants|||Count of Participants
2574171|NCT02486302|Primary|Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 24|DAS28 calculated as average of SJC and TJC using the 28 joints count, ESR (mm/h) and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC t<=1; 2) SJC =<1; 3) PASI <= 1 or BSA <=3; 4) Participant pain on VAS <= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain [best] and 100 mm = maximum possible pain [worst]; 5) PtGA on VAS <= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) HAQ-DI <= 0.5(HAQ=3.16-[0.028*FFbH); 7) Tender enthesial points <= 1.|Week 24|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA evaluable for this outcome measure.|||Participants|||Count of Participants
2574172|NCT02486302|Primary|Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24|ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 <= ASDAS < 1.3; moderate disease activity: 1.3 <= ASDAS < 2.1; high disease activity: 2.1 <= ASDAS <= 3.5; very high disease activity: 3.5 < ASDAS.|Week 24|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA evaluable for this outcome measure.|||Participants|||Count of Participants
2574173|NCT02486302|Primary|"Number of Participants With Plaque Psoriasis (PsO) Who Achieved 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment (PGA) of Clear or Almost Clear and DLQI Total Score of 0 or 1 at Week 24"|PASI:combined assessment of lesion severity & area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) & severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear & almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).|Week 24|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO evaluable for this outcome measure.|||Participants|||Count of Participants
2574174|NCT02486302|Primary|Number of Participants With Psoriatic Arthritis (PsA) Who Achieved Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 12|DAS28 calculated as average of from SJC and TJC using the 28 joints count, ESR (mm/h), PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant was classified as MAD if the participant met at least 5 of 7 following criteria: 1) TJC <=1; 2) SJC =<1; 3) PASI <= 1 or body surface area (BSA) <=3; 4) Participant pain on VAS <= 15 (assessed pain using a 0 mm - 100 mm VAS scale where 0 mm = minimum possible pain [best] and 100 mm = maximum possible pain [worst]; 5) PtGA on VAS <= 20 (all assessed on a VAS 0-100cm, where 0 = no disease activity and 100=high disease activity); 6) Health assessment questionnaire disability index (HAQ-DI) <= 0.5(HAQ=3.16-[0.028* hannover functional questionnaire [FFbH]); 7) Tender enthesial points <= 1.|Week 12|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsA evaluable for this outcome measure.|||Participants|||Count of Participants
2574175|NCT02486302|Primary|Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12|ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, PtGA (all assessed on a VAS (0-100cm, where 0 = no disease activity and 100=high disease activity), CRP (mg/L). ASDAS ranged as inactive disease: 0 <= ASDAS < 1.3; moderate disease activity: 1.3 <= ASDAS < 2.1; high disease activity: 2.1 <= ASDAS <= 3.5; very high disease activity: 3.5 < ASDAS.|Week 12|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with axSpA evaluable for this outcome measure.|||Participants|||Count of Participants
2574176|NCT02486302|Primary|Number of Participants With PsO Who Achieved 75% Improvement From Baseline in Psoriasis Area & Severity Index(PASI75) Score or Physician's Global Assessment(PGA) of Clear or Almost Clear And Dermatology Life Quality Index(DLQI) Total Score of 0 or 1|PASI:combined assessment of lesion severity & area affected into single score as: 0(no disease)-72(maximal disease). Body divided into=head,upper/lower limbs,trunk;each area scored & scores combined for final PASI. For each section % area of skin involved was estimated:0(0%)-6(90-100%) & severity estimated by clinical signs of erythema,induration,desquamation; range 0(none)-4(very marked). Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1,upper limbs=0.2,trunk=0.3,lower limbs=0.4). PASI75:>=75% reduction in PASI from Baseline. PGA psoriasis:average assessment of erythema,induration,desquamation of all psoriatic lesions, scored on 5-point scale: 0(no psoriasis)-4(severe disease). Clear & almost clear indicate score 0 or 1. DLQI:10-item questionnaire, measures impact of skin disease on participant's quality of life. Each question evaluated on 4-point scale as: 0(not at all)-3 (very much). Total DLQI score:0(no effect)-30(extremely large effect).|Week 12|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with PsO.|||Participants|||Count of Participants
2574178|NCT02486302|Primary|Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 and Maintained Till 52 Weeks|DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR [mm/h] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Week 12 up to Week 52|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure.|||Participants|||Count of Participants
2574179|NCT02486302|Primary|Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24|DAS28 calculated as weighted average of SJC and TJC using the 28 joints count, ESR [mm/h] and PtGA of disease activity (recorded on a VAS scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28<2.6 = remission, DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Week 24|PP set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure.|||Participants|||Count of Participants
2574180|NCT02486302|Primary|Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12|Disease activity score based on 28-joints count (DAS28) calculated as weighted average of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/h]) and patient's global assessment (PtGA) of disease activity (recorded on a visual analog scale [VAS] scale of 0 mm-100 mm, where 0 = no disease activity and 100=high disease activity). DAS28 <2.6 = remission, DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Week 12|Per-protocol (PP) set=all documented participants who were treated, had at least 1 post-baseline value, AE documented and no major protocol deviation. Overall number of participants analyzed signifies participants of PP set with RA evaluable for this outcome measure.|||Participants|||Count of Participants
2574181|NCT02486211|Secondary|Number of Participants With Severe or Intracranial Bleeding|Bleeding that does not stop with direct pressure, requires transfusion, or occurs in the intracranial vault|28 days||||Participants|||Count of Participants
2574182|NCT02486211|Secondary|Nausea or Vomiting|nausea requiring antiemetic medications or clinical vomiting|during study drug administration (7 days)||||Participants|||Count of Participants
2574183|NCT02486211|Secondary|Seizures (Number of Patients Who Experience Seizures as Detected by EEG Monitoring With or Without Clinical Correlate)|detected by EEG monitoring with or without clinical correlate|during study drug administration (7 days)||||Participants|||Count of Participants
2574184|NCT02486211|Secondary|Time to Awakening|Defined as the time from enrollment to awakening|up to 28 days||||days||Inter-Quartile Range|Median
2574185|NCT02486211|Primary|Rate of Awakening (Number of Patients Who Are Able to Follow Commands)|"Defined as the ability to follow commands (i.e. wiggle your toes open your eyes squeeze my fingers. This corresponds to a Full Outline of Unresponsiveness motor score of 4. FOUR (full outline of unresponsiveness) measures the following: Eye Response, Motor Response, Brainstem Reflexes, and Respirations."|up to 28 days||||Participants|||Count of Participants
2574186|NCT02486016|Primary|Partial Area Under the Curve (AUC) Attained With Early and Late Heat in Each of the Three Fentanyl TDSs (Reference and Generic)|"Partial area under the flux-time curve of fentanyl calculated from 11 to 14 h for Early Heat and 18 to 21 h for Late Heat study designs~Blood samples obtained at 15 min prior to patch application [baseline], and at 1:00, 10:00, 10:55, 11:05, 11:15, 11:25, 11:35, 11:45, 12:00, 13:00, 14:00, 16:00, 17:00, 17:55, 18:05, 18:15, 18:25, 18:35, 18:45, 19:00, 20:00, 21:00, and 22:00 h post-patch application"|six procedure days for each participant|Partial area under the flux-time curve of fentanyl from 11 to 14 h for Early Heat and 18 to 21 h for Late Heat study designs. Each was corrected to account for different TDS sizes. Comparison was early heat to late heat differences.|||h*ng/mL||Standard Deviation|Mean
2574187|NCT02485925|Secondary|Procedure Time, Ablation Time and Fluoroscopy Time|Procedure Time, Ablation Time and Fluoroscopy Time in minutes|1 day during procedure|Safety population|||Minutes||Standard Deviation|Mean
2574188|NCT02485925|Secondary|Percent of Subjects With Pulmonary Vein Reconnection for the Index Procedure|Percentage of subjects with PV reconnection after the first ablation|1 day during procedure|Safety population with pulmonary vein reconnection data available|||Percentage of participants||95% Confidence Interval|Number
2574189|NCT02485925|Secondary|Average Contact Force Per Pulmonary Vein Ablation Procedure|Contact force (CF) is the force (g) between the device tip and endocardial wall. Two subjects didn't have CF data|1 day during procedure|Safety population with contact force data available|||Grams||Standard Deviation|Mean
2574190|NCT02485925|Secondary|Percentage of Patients Where Acute Success Was Achieved|Confirmation of entrance block in all pulmonary veins (PVs) with an isoproterenol intravenous challenge 0.5h post procedure. Exit Block is optional for this study.|0.5 hours|Safety Population, i.e., all enrolled subjects who undergone insertion of the study catheter during the procedure|||Percentage of participants||95% Confidence Interval|Number
2574191|NCT02485925|Primary|Percentage of Patients With Freedom From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes|The primary effectiveness endpoint for this study is freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up after the index ablation procedure (includes a three-month blanking period).|12 Months|Per protocol population: Subjects in the ITT Population who undergone insertion of the study catheter and AF ablation procedure, and had the 12th month primary efficacy endpoint data.|||Percentage of Participants||95% Confidence Interval|Number
2574217|NCT02485561|Primary|Intentions to Get Screened for Colon Cancer|Intention was measured on all surveys with the mean of 3 items assessed using slider bars (coded 1=not at all - 100=extremely) asking about the likelihood of being screened in the next 6 months, the importance of screening, and commitment to screening. Higher scores indicate greater intentions to get screened for colorectal cancer.|Immediately post-intervention|Participants who completed the baseline, intervention, and immediately post-intervention survey|||units on a 0-100 scale||Standard Deviation|Mean
2574192|NCT02485912|Secondary|To Assess the Immunogenicity Generated by Heterologous Prime-boost Immunisation With Monovalent ChAd3-EBO Z (2.5 x 1010 vp - 3.7 x 1010vp) and MVA-EBO Z (1.0 x 108 Pfu) in Healthy Senegalese Volunteers Aged 18-50 Years|"Ebolavirus specific immunogenicity will be assessed by a variety of immunological assays. The primary immunogenicity outcome measures are ELISA and neutralization antigen-specific assays for antibody responses and intracellular cytokine staining (ICS) assay for T cell responses.~Exploratory outcome measures will include ex-vivo ELISPOT, plasma blast assays and flow cytometry performed with research samples collected at different study timepoints as well as other immunogenicity assays throughout the study. An evaluation of genetic factors associated with immune responses may be performed as exploratory evaluation. Vaccine-induced mRNA expression profiles during 1 week after vaccination may also be performed as an exploratory evaluation."|26 weeks||||participants|||Number
2574193|NCT02485912|Primary|Safety and Tolerability of Administration of ChAd3-EBO Z and MVA-EBO Z 7 Days Later. This Will be Done by Recording the Number of Participants Who Experience Adverse Events and the Severity of Any Adverse Events.|"The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events.~The following parameters will be assessed for both groups:~Occurrence of solicited local reactogenicity signs and symptoms for 7 days following the vaccination~Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following the vaccination~Occurrence of unsolicited adverse events for 28 days following the vaccination~Change from baseline for safety laboratory measures~Occurrence of serious adverse events during the whole study duration"|26 weeks||||participants|||Number
2574194|NCT02485834|Other Pre-specified|Change in FDG-PET SUV Measures||Up to 14 days prior to surgery|||||||
2574195|NCT02485834|Secondary|Number of Participants Who Reported Grade 3 or Higher Adverse Events|The number of patients who reported grade 3 or higher Adverse Events according to Common Terminology Criteria for Adverse Events version 4.0.|Up to 30 days after completion of protocol treatment|Only patients who received treatment and were assessed for adverse events and completed the adverse events form were included in this analysis.|||Participants|||Count of Participants
2574196|NCT02485834|Secondary|Number of Patients Had Pathologic Complete Response|The number of patients had pathologic complete response (pCR). (pCR is defined as no gross or microscopic tumor identified with the surgical specimen. All lymph nodes should be free of tumor to document a PCR. If no gross tumor is visible, section around the area of inflammation (nodularity) should be made every 2-3 cm and specimens examined.)|Up to 3 years|Due to small numbers, overall results are summarized across all randomized patients to protect patient confidentiality.|||Participants|||Count of Participants
2574197|NCT02485834|Secondary|Number of Patients Achieved R0 Resection During Surgery|The number of patients achieved R0 resection during surgery|At time of surgery|Due to small numbers, overall results are summarized across all randomized patients to protect patient confidentiality.|||Participants|||Count of Participants
2574198|NCT02485834|Secondary|Progression-free Survival|Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Up to 3 years|Due to small numbers, overall results are summarized across all randomized patients to protect patient confidentiality.|||months||95% Confidence Interval|Median
2574199|NCT02485834|Primary|Overall Survival|Overall survival is defined as the time from date of randomization to death due to any cause.|Up to 3 years|Due to small numbers, overall results are summarized across all randomized patients to protect patient confidentiality.|||months||95% Confidence Interval|Median
2574200|NCT02485717|Secondary|This Assessment Includes Assessing the AUC 0-12h (ng•h/mL) of Spinosad (Spinosyn A and Spinosyn D) Pre-dose and During 12 Hours Post-dose of Natroba™ in Pediatric Subjects (Ages 4-16 Years).|"Note: All of the spinosad (spinosyn A and spinosyn D) plasma levels tested were below the limit of quantification (3 ng/mL). Therefore, the mean and standard deviation of AUC 0-12h read 0 in the Outcome Measure Data Table."|12 Hours||||ng•h/mL||Standard Deviation|Mean
2574201|NCT02485717|Secondary|This Assessment Includes Assessing the Tmax (Hours) of Spinosad (Spinosyn A and Spinosyn D) Pre-dose and During 12 Hours Post-dose of Natroba™ in Pediatric Subjects (Ages 4-16 Years).|"Note: All of the spinosad (spinosyn A and spinosyn D) plasma levels tested were below the limit of quantification (3 ng/mL). Therefore, the mean and standard deviation of Tmax read 0 in the Outcome Measure Data Table."|12 Hours||||hours||Standard Deviation|Mean
2574202|NCT02485717|Secondary|This Assessment Includes Assessing the Cmax (ng/mL) of Spinosad (Spinosyn A and Spinosyn D) Pre-dose and During 12 Hours Post-dose of Natroba™ in Pediatric Subjects (Ages 4-16 Years).|"Note: All of the spinosad (spinosyn A and spinosyn D) plasma levels tested were below the limit of quantification (3 ng/mL). Therefore, the mean and standard deviation of Cmax read 0 in the Outcome Measure Data Table."|12 Hours||||ng/mL||Standard Deviation|Mean
2574203|NCT02485717|Secondary|This Assessment Includes Assessing the AUC 0-12h (μg•h/mL) of Benzyl Alcohol Pre-dose and During 12 Hours Post-dose of Natroba™ in Pediatric Subjects (Ages 4-16 Years).||12 Hours||||μg•h/mL||Standard Deviation|Mean
2574204|NCT02485717|Secondary|This Assessment Includes Assessing the Tmax (Hours) of Benzyl Alcohol Pre-dose and During 12 Hours Post-dose of Natroba™ in Pediatric Subjects (Ages 4-16 Years).||12 Hours||||hours||Standard Deviation|Mean
2574205|NCT02485717|Secondary|This Assessment Includes Assessing the Cmax (μg/mL) of Benzyl Alcohol Pre-dose and During 12 Hours Post-dose of Natroba™ in Pediatric Subjects (Ages 4-16 Years).||12 Hours||||μg/mL||Standard Deviation|Mean
2574206|NCT02485717|Primary|Number of Index Subjects Completely Cured of Scabies After a Single Treatment|The primary efficacy assessment is the proportion of index subjects completely cured of scabies by Day 28. Complete cure is defined as a demonstration of both clinical cure (all signs and symptoms have completely resolved, including burrows, inflammatory/non-inflammatory lesions and pruritus) and microscopic or dermatoscopic cure demonstrating the absence of mites, eggs, and/or scybala, and a negative dermatoscopy for burrows.|28 days after treatment|Participants analyzed are based on the number of subjects who had no missing observations in each study group.|||Participants|||Count of Participants
2574207|NCT02485704|Primary|Number of Index Subjects Completely Cured of Scabies After a Single Treatment|The primary efficacy assessment is the proportion of index subjects completely cured of scabies by Day 28. Complete cure is defined as a demonstration of both clinical cure (all signs and symptoms have completely resolved, including burrows, inflammatory/non-inflammatory lesions and pruritus) and microscopic or dermatoscopic cure demonstrating the absence of mites, eggs, and/or scybala, and a negative dermatoscopy for burrows.|28 days after treatment|Participants analyzed are based on the number of subjects who had no missing observations in each study group.|||Participants|||Count of Participants
2574208|NCT02485561|Other Pre-specified|Perceived Benefits and Barriers of Colorectal Cancer Screening|Perceived colorectal cancer screening benefits (8 items) barriers (6 items) are assessed with items from previously validated scales. Response options range from 1=strongly disagree to 7=strongly agree. Mean scores were created for each scale; higher scores reflect greater perceived benefits and barriers of getting screened. Means will be compared between all three study groups.|Immediately post-intervention|Participants who completed the baseline survey, intervention, and immediate post-intervention survey|||units on a scale||Standard Deviation|Mean
2574209|NCT02485561|Other Pre-specified|Worry|Worry was assessed with four items regarding worry about getting colorectal cancer, having a test that shows they have colorectal cancer, concern that colorectal cancer screening will be physically uncomfortable, and concern that there could be complications from the test. Response options ranged from 1=strongly disagree to 5=strongly agree. Mean scores were created (Range 1-5); higher scores reflect greater worry. Means will be compared between all three study groups.|Immediately post-intervention|Participants who completed the baseline survey, intervention, and immediate post-intervention survey|||units on a scale||Standard Deviation|Mean
2574210|NCT02485561|Other Pre-specified|Social Influence|Social influence will be assessed with three items developed for this study based on standard measures that include physician, family, and friends as important social referents encouraging colorectal cancer screening. Response options range from 1=strongly disagree to 7=strongly agree. Mean scores were created and higher scores reflect greater perceived social influence for getting screened for colorectal cancer. Means will be compared between all three study groups.|Immediately post-intervention|Participants who completed the baseline survey, intervention, and immediate post-intervention survey|||units on a scale||Standard Deviation|Mean
2574211|NCT02485561|Secondary|Absolute Perceived Susceptibility to Colon Cancer|Absolute perceived risk was assessed with three items: I am at risk for developing colorectal cancer, If I do not get screened regularly, I would feel vulnerable to developing colorectal cancer, If I do not get screened regularly, it is likely that I will develop colorectal cancer. Response options range from 1=strongly disagree to 5=strongly agree. Mean scale scores were created and higher scores reflect greater perceived susceptibility to colorectal cancer. Mean scores will be compared between all three study groups.|Immediately post-intervention|Participants who completed the baseline survey, intervention, and immediate post-intervention survey|||units on a 5-point response scale||Standard Deviation|Mean
2574212|NCT02485561|Secondary|Defensive Information Processing|Seven scales assessing defensive information processing will be assessed using previously validated measures for opt-out behavior (3 items), opt-out information (1 item), blunting (2 items), self-exemption (5 items), deny immediacy (3 items), counterarguing (4 items), and minimize the harm (2 items). Response options range from 1=strongly disagree to 7=strongly agree. Mean scores are created for each scale and higher scores reflect greater defensive information processing. Means will be compared between all three study groups.|Immediately post-intervention|Participants who completed the baseline survey, intervention, and immediate post-intervention survey|||units on a 7-point response scale||Standard Deviation|Mean
2574213|NCT02485561|Secondary|Affect|Using the Positive and Negative Affect Schedule, we assessed the strength of 5 positive (happy, proud, strong, inspired, hopeful) and 5 negative (angry, guilty, sad, nervous, afraid) emotions felt during the assigned reading (1=Not at all - 7=Extremely). Higher mean subscale scores reflect stronger positive and negative emotions. Means will be compared between all three study groups.|Immediately post-intervention|Participants who completed the baseline survey, intervention, and immediate post-intervention survey|||units on a 7-point response scale||Standard Deviation|Mean
2574214|NCT02485561|Secondary|Self-efficacy for Getting Screened for Colon Cancer|Six items assess confidence in getting screened for colon cancer despite common barriers. Mean scores are created from response options that range from 1=not at all confident to 7=very confident. Higher scores reflect greater confidence in getting colorectal cancer screening. Means will be compared between all three study groups.|Immediately post-intervention|Participants who completed the baseline survey, intervention, and immediate post-intervention survey|||units on a 7-point response scale||Standard Deviation|Mean
2574215|NCT02485561|Secondary|Three Measures of Engagement|"Confirmatory factor analyses did not support an aggregate measure adapted from an existing transportation scale, so a single item What I just read affected me emotionally was used to measure emotional engagement for all participants. For participants assigned to either narrative condition, two items reflected cognitive (imagery) engagement While I was reading the story, I could easily picture the events in it taking place and I had a vivid mental image of the person in the story. Mean scores were created for cognitive engagement. Two items reflected self-referencing engagement: I could picture myself in the scene of the events described in the story and The events in the story are relevant to my life were assessed and mean scores created for self-referencing engagement. Responses for all items were 1=Not at all - 7=Very much. Higher mean scores reflected higher engagement."|Immediately post-intervention||||units on a scale||Standard Deviation|Mean
2574216|NCT02485561|Secondary|Identification With the Character|Participants assigned to narrative conditions were asked if they liked and felt similar to the character in the story they read with 3 items each with response options 1=Strongly Disagree - 5=Strongly Agree. Measures were based on previous work by the study investigators. Mean scores for liking and similarity were created; higher scores reflect higher perceived similarity and liking for the character. Means will be compared between the two groups assigned to read a narrative.|Immediately post-intervention|Participants who completed baseline, intervention, and immediately post-intervention survey|||units on a 5-point response scale||Standard Deviation|Mean
2574696|NCT02478359|Secondary|Personal Health Questionnaire, PHQ8 - 12 Months|The reported mean change between the baseline and 12 Months scores. Score range is 0-24. A negative change score indicates less depressive symptoms.|12 months|As treated population who completed the survey|||score on a scale||Standard Deviation|Mean
2574218|NCT02485483|Primary|Percentage of Participants With Prevalence of Depressive Symptomatology Based on a BDI-II Score Greater Than or Equal to (≥)14 or PHQ-9 Score ≥5: VADERA II|PHQ-9 is a self-reported questionnaire measuring depressive symptoms. This is a 9-item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27; with 0-4 indicating no depressive symptoms, 5-9 mild, 10-14 moderate, 15-19 moderately severe, and 20-27 severe depression. BDI-II Scale is a 21-item self-reported questionnaire measuring existence and severity of depression symptoms. Symptoms are each scored on a 4-point scale of 0 (no symptom) to 3 (severe symptom). Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 minimal, 14-19 mild, 20-28 moderate, and 29-63 severe depression. Participants with a BDI-II score ≥14 or a PHQ-9 score ≥5 were classified as having depressive symptomatology. Participants were evaluated by positive depressive symptomatology for each questionnaire as well as being positive for both questionnaires combined or at least one of the questionnaires.|Baseline|Full analysis set of VADERA II population.|||percentage of participants||95% Confidence Interval|Number
2574219|NCT02485483|Primary|BDI-II Summary Score: VADERA II|BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.|Baseline|Full analysis set of VADERA II population. Number of participants analyzed = participants with BDI-II summary score assessment at baseline.|||scores on a scale||Standard Deviation|Mean
2574220|NCT02485483|Primary|PHQ-9 Summary Score: VADERA II|The PHQ-9 is a self-reported questionnaire measuring depressive symptoms. This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27; with 0-4 being minimum indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.|Baseline|Full analysis set of VADERA II population defined as all study participants diagnosed with RA, who had given informed consent, and had completed at least one of the depression questionnaires. Number of participants analyzed = participants with PHQ-9 summary score assessment at baseline.|||scores on a scale||Standard Deviation|Mean
2574221|NCT02485483|Primary|MADRS at Week 12 ± 2: VADERA I|The MADRS, an interview addressing 10 characteristics of depressive symptomatology, was used as the gold standard. The symptom-related information provided by each participant was rated on item-specific scales ranging from 0 (best) to 6 (worst) in order to evaluate individual symptom severity. Total score was sum of 10 characteristics, ranging between 0 to 60; 0, no depression; 60, severely depressed. Sum scores exceeding 12 indicated clinical relevance suggested mild to severe symptomatology.|Week 12 ± 2|Validation analysis set of VADERA I population. Number of participants analyzed = participants with MADRS assessment at specified time-point.|||scores on a scale||Standard Deviation|Mean
2574222|NCT02485483|Primary|MADRS at Baseline: VADERA I|The MADRS, an interview addressing 10 characteristics of depressive symptomatology, was used as the gold standard. The symptom-related information provided by each participant was rated on item-specific scales ranging from 0 (best) to 6 (worst) in order to evaluate individual symptom severity. Total score was sum of 10 characteristics, ranging from 0 to 60; 0, no depression; 60, severely depressed. Sum scores exceeding 12 indicated clinical relevance suggested mild to severe symptomatology.|Baseline|Validation analysis set of VADERA I population. Number of participants analyzed = participants with MADRS assessment at baseline.|||scores on a scale||Standard Deviation|Mean
2574223|NCT02485483|Primary|WHO-5 Index at Week 12 ± 2: VADERA I|"WHO-5 questionnaire contains five items related to cheerfulness, calmness, feelings of vigor, feelings of being well rested after sleep, and personal interest. The respondent rated each question on a 6-point scale ranging from 0 (at no time) to 5 (all of the time) according to the proportion of time over the preceding 2 weeks that applied to the attribute in question. Scores were summated, with raw score ranging from 0 to 25. Then the scores were transformed to 0-100 by multiplying by 4, whereas 0 indicated the worst possible emotional well-being and 100 the best."|Week 12 ± 2|Validation analysis set of VADERA I population. Number of participants analyzed = participants with WHO-5 score assessment at specified time-point.|||scores on a scale||Standard Deviation|Mean
2574224|NCT02485483|Primary|WHO-5 Index at Baseline: VADERA I|"WHO-5 questionnaire contains five items related to cheerfulness, calmness, feelings of vigor, feelings of being well rested after sleep, and personal interest. The respondent rated each question on a 6-point scale ranging from 0 (at no time) to 5 (all of the time) according to the proportion of time over the preceding 2 weeks that applied to the attribute in question. Scores were summated, with raw score ranging from 0 to 25. Then the scores were transformed to 0-100 by multiplying by 4, whereas 0 indicated the worst possible emotional well-being and 100 the best."|Baseline|Validation analysis set of VADERA I population. Number of participants analyzed = participants with WHO-5 score assessment at baseline.|||scores on a scale||Standard Deviation|Mean
2574225|NCT02485483|Primary|BDI-II Score at Week 12 ± 2: VADERA I|BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.|Week 12 ± 2|Validation analysis set of VADERA I population. Number of participants analyzed = participants with BDI-II score assessment at specified time-point.|||scores on a scale||Standard Deviation|Mean
2574239|NCT02485301|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities|Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.|At Day 30|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 30.|||Percentage of participants|||Number
2574226|NCT02485483|Primary|BDI-II Score at Baseline: VADERA I|BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represents a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.|Baseline|Validation analysis set of VADERA I population. Number of participants analyzed = participants with BDI-II score assessment at baseline.|||scores on a scale||Standard Deviation|Mean
2574227|NCT02485483|Primary|PHQ-9 Score at Week 12 ± 2: VADERA I|The PHQ-9 is a self-reported questionnaire measuring depressive symptoms. This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27; with 0-4 being minimum indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.|Week 12 ± 2|Validation analysis set of VADERA I population. Number of participants analyzed = participants with PHQ-9 score assessment at specified time-point.|||scores on a scale||Standard Deviation|Mean
2574228|NCT02485483|Primary|PHQ-9 Score at Baseline: VADERA I|The PHQ-9 is a self-reported questionnaire measuring depressive symptoms.This is a nine item measure with a response score for each item on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Thus, the total score ranges from 0 to 27; with 0-4 being minimum indicating no depressive symptoms, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, 20-27 severe depression.|Baseline|Validation analysis set of VADERA I population defined as all study participants diagnosed with RA, who had given informed consent, and had no documented depression at baseline. Number of participants analyzed = participants with PHQ-9 score assessment at baseline.|||scores on a scale||Standard Deviation|Mean
2574229|NCT02485353|Secondary|Procedure or Procedure Related Adverse Events|Number of unique patients who had a procedure or treatment related (possible, probable or definite) adverse events. (graded per NCI CTC v4.0)|Up to 1 year|All patients enrolled and received treatment|||Participants|||Count of Participants
2574230|NCT02485353|Primary|Rate of Complete Remission|Percentage of patients who have complete remission as defined by the International Working Group for AML: morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi or CRp)|2 months|All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit|||percentage of patients|||Number
2574231|NCT02485301|Secondary|Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies|A seronegative subject (S-) is a subject whose titer is below (<) 36.11 EU/mL. A seropositive subject (S+) is a subject whose titer is greater than or equal to (≥) 36.11 EU/mL.|At Day 0, Day 30, Month 6 and Month 12|The analysis was performed on the According-to-Protocol (ATP) cohort for Immunogenicity - AE and Humoral Immunity Sub-cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available.|||Percentage of participants|||Number
2574232|NCT02485301|Secondary|Concentrations of Anti-glycoprotein Ebola Zaire Virus (Anti-GP EBOV)|Anti-GP EBOV antibody concentrations were measured by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMC), and expressed in ELISA units per milliliter (EU/mL).|At Day 0, Day 30, Month 6 and Month 12|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity - AE and Humoral Immunity Sub-cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available.|||EU/mL||95% Confidence Interval|Geometric Mean
2574233|NCT02485301|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (up to Month 12)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2574234|NCT02485301|Primary|Number of Subjects With Adverse Events of Specific Interest (AESI)|AESI included clinical symptoms of thrombocytopenia.|During the 7-Day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2574235|NCT02485301|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities|Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.|At Month 12|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 12.|||Percentage of participants|||Number
2574236|NCT02485301|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities|Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.|At Month 6 + 30 Days|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6 + 30 Days timepoint.|||Percentage of participants|||Number
2574237|NCT02485301|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities|Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.|At Month 6 + 6 Days|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6 + 6 Days timepoint.|||Percentage of participants|||Number
2574238|NCT02485301|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities|Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.|At Month 6|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6.|||Percentage of participants|||Number
2574240|NCT02485301|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities|Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.|At Day 6|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 6.|||Percentage of participants|||Number
2574241|NCT02485301|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities|Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.|At Day 3|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 3.|||Percentage of participants|||Number
2574242|NCT02485301|Primary|Percentage of Subjects With Biochemical Laboratory Abnormalities|Biochemical parameters assessed included: aminotransferase and creatinine. Reference range indicators used were: high, low, normal.|At Screening|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Screening.|||Percentage of participants|||Number
2574243|NCT02485301|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.|At Month 12|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 12.|||Percentage of participants|||Number
2574244|NCT02485301|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.|At Month 6 + 30 Days|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6 + 30 Days timepoint.|||Percentage of participants|||Number
2574245|NCT02485301|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.|At Month 6 + 6 Days|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6 + 6 Days timepoint.|||Percentage of participants|||Number
2574246|NCT02485301|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.|At Month 6|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6.|||Percentage of participants|||Number
2574247|NCT02485301|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.|At Day 30|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 30.|||Percentage of participants|||Number
2574248|NCT02485301|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.|At Day 6|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 6.|||Percentage of participants|||Number
2574249|NCT02485301|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.|At Day 3|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 3.|||Percentage of participants|||Number
2574250|NCT02485301|Primary|Percentage of Subjects With Haematological Laboratory Abnormalities|Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin), as well as differential count and platelet count. Reference range indicators used were: high, low, normal.|At Screening|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Screening.|||Percentage of participants|||Number
2574251|NCT02485301|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 30-Day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2574252|NCT02485301|Primary|Number of Subjects With Solicited General Adverse Events|Assessed solicited general adverse events were fatigue, fever [defined as axillary temperature higher than or equal to (≥) 37.5 degrees Celsius (°C)], gastrointestinal (gastro) adverse events [nausea, vomiting, diarrhoea and/or abdominal pain] and headache. Any = occurrence of any general adverse events regardless of intensity grade or relationship to vaccination. Grade 3 fatigue, gastrointestinal symptoms and headache = adverse event that prevented normal activities. Grade 3 fever = fever ≥ 39.5 °C. Related = adverse event assessed by the investigator as related to the vaccination.|During the 7-Day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented, who filled in their symptom sheets.|||Participants|||Count of Participants
2574253|NCT02485301|Primary|Number of Subjects With Solicited Local Adverse Events|Assessed solicited local adverse events were pain, redness and swelling. Any = occurrence of any solicited local adverse event regardless of their intensity grade. Grade 3 Pain = significant pain at rest. Prevented normal every day activities. Grade 3 Redness/Swelling = redness/swelling spreading beyond 100 millimeters (mm) from injection site.|During the 7-Day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort - Adverse Event (AE) and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented, who filled in their symptom sheets.|||Participants|||Count of Participants
2574254|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 210 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 210 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 210 minutes after drink administration|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
2574255|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 180 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 180 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 180 minutes after drink administration|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
2574256|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 150 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 150 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 150 minutes after drink administration|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
2574257|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 120 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 120 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 120 minutes after drink administration|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
2574266|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 30 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 30 minutes after drink administration.|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
2574258|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 90 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 90 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 90 minutes after drink administration|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
2574259|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Drink Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 30 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 30 minutes after drink administration|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
2574260|NCT02485158|Primary|Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Capsule Administration|Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 30 minutes after capsule administration and before drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
2574261|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 210 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 210 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 210 minutes after drink administration.|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
2574262|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 180 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 180 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 180 minutes after drink administration.|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
2574263|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 150 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 150 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 150 minutes after drink administration.|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
2574264|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 120 Minutes After Drink Administraion|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 120 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 120 minutes after drink administration.|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
2574265|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 90 Minutes After Drink Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 90 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 90 minutes after drink administration.|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
2574267|NCT02485158|Primary|Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule Administration|Drug effects will be measured using the Drug Effects Questionnaire (Fischman & Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 30 minutes after capsule administration and before drink administration. Baseline was measure 15 minutes prior to capsule administration.|Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration|Participants who completed all sessions|||units on a scale||Standard Deviation|Mean
2574268|NCT02484911|Secondary|Proportion of Participants Receiving MEC With No Vomiting in the Delayed Phase|"Overall Phase was defined as 24 to 120 hours following initiation of chemotherapy.~No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)."|24 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
2574269|NCT02484911|Secondary|Proportion of Participants Receiving MEC With No Vomiting in the Acute Phase|"Overall Phase was defined as 0 to 24 hours following initiation of chemotherapy.~No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)."|0 to 24 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
2574270|NCT02484911|Secondary|Proportion of Participants Receiving MEC With No Vomiting in the Overall Phase|"Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.~No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)."|0-120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
2574271|NCT02484911|Secondary|Proportion of Participants Receiving MEC With Complete Response in the Delayed Phase|"Delayed phase was defined as 24 to 120 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy."|24 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
2574272|NCT02484911|Secondary|Proportion of Participants Receiving MEC With Complete Response in the Acute Phase|Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.|0 to 24 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
2574273|NCT02484911|Secondary|Proportion of Participants Receiving HEC With No Vomiting in the Delayed Phase|"Overall Phase was defined as 24 to 120 hours following initiation of chemotherapy.~No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)."|24 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
2574274|NCT02484911|Secondary|Proportion of Participants Receiving HEC With No Vomiting in the Acute Phase|"Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.~No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue ）"|0 to 24 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
2574275|NCT02484911|Secondary|Proportion of Participants Receiving HEC With No Vomiting in the Overall Phase|"Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.~No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)."|0 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
2574276|NCT02484911|Secondary|Proportion of Participants Receiving HEC With Complete Response in the Delayed Phase|"Delayed phase was defined as 24 to 120 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy."|24 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
2574277|NCT02484911|Secondary|Proportion of Participants Receiving HEC With Complete Response in the Acute Phase|Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.|0 to 24 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
2574278|NCT02484911|Primary|Proportion of Participants Receiving MEC With Complete Response in Overall Phase|"Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy."|0 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
2574279|NCT02484911|Primary|Proportion of Participants Receiving HEC With Complete Response in Overall Phase|"Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy."|0 to 120 hours|FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.|||Participants|||Count of Participants
2574281|NCT02484859|Secondary|Number of Participants With Postoperative Nausea and Vomiting|Postoperative nausea, retching, and vomiting on the day of surgery will be evaluated with a four-point ordinal scale (0-none, 1-nausea, 2-retching, 3-vomiting) at the post anaesthetic care unit, and the surgical ward. The evaluation will begin after the patient arrives at the post anaesthetic care unit, and will continue for 24 hours.|following extubation, up to 24 hours||||Participants|||Count of Participants
2574282|NCT02484859|Secondary|Postoperative Pain|Postoperative pain scores on the day of surgery will be evaluated with a visual analog scale (0: no pain, 10: worst pain ever) at the post anaesthetic care unit (PACU), and the surgical ward. The evaluation will begin after the patient arrives at the post anaesthetic care unit, and will continue for 24 hours.|following extubation, up to 24 hours||||units on a scale||Inter-Quartile Range|Median
2574283|NCT02484859|Secondary|Bleeding Rate|In the end of each surgery, bleeding rate will be calculated as ml/min by dividing total bleeding (amount of blood in the graded suction and sponges minus total irrigation fluid) to the duration of surgery (excluding local anesthetic infiltration, and nasal packing).|throughout surgery, up to 3 hours||||ml/min||Standard Deviation|Mean
2574284|NCT02484859|Secondary|Time to Achieve Intraoperative Bleeding Score < 3|The intraoperative bleeding score will be reported by the surgeon throughout surgery. At the start of the surgery, a timer will be used to measure the duration to achieve a bleeding score of 2.|throughout surgery, up to 20 minutes||||minutes||Standard Deviation|Mean
2574285|NCT02484859|Primary|Intraoperative Bleeding Score|"Intraoperative bleeding score is reported by the surgeon according to Boezaart Surgical Field Grading scale. The scale ranges from 0 to 5. '0' is the best, and '5' is the worst outcome.~The scale construct is:~0 No bleeding.~Slight bleeding, no suction is required.~Slight bleeding, occasional suctioning required.~Slight bleeding, frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed.~Moderate bleeding, frequent suctioning required. Bleeding threatens surgical field as soon as suction is removed.~Severe bleeding, constant suctioning required. Bleeding appears faster than suctioning.~Thoroughout the intraoperative period, the surgeon is free to report a score at any time he/she sees appropriate."|throughout surgery, up to 3 hours||||units on a scale||Inter-Quartile Range|Median
2574286|NCT02484807|Secondary|Clinical Relevance Blood Gas Analysis Oxygen Saturation|"Changes of medication levels after adjustment of combination therapy if clinically indicated~correlation with clinical routine parameters indicating clinical disease status"|baseline vs. measurement after 3-6 months||||% oxygen saturation||Standard Deviation|Mean
2574287|NCT02484807|Secondary|Clinical Relevance Echocardiography Tricuspid Annular Plane Systolic Excursion (TAPSE)|"Changes of medication levels after adjustment of combination therapy if clinically indicated~correlation with clinical routine parameters indicating clinical disease status"|baseline vs. measurement after 3-6 months||||mm||Standard Deviation|Mean
2574288|NCT02484807|Secondary|Clinical Relevance Echocardiography Systolic Pulmonary Arterial Pressure (sPAP)|"Changes of medication levels after adjustment of combination therapy if clinically indicated~correlation with clinical routine parameters indicating clinical disease status"|baseline vs. measurement after 3-6 months||||mmHg||Standard Deviation|Mean
2574289|NCT02484807|Secondary|Clinical Relevance NTproBNP|"Changes of medication levels after adjustment of combination therapy if clinically indicated~correlation with clinical routine parameters indicating clinical disease status"|baseline vs. measurement after 3-6 months||||ng/ml||Standard Deviation|Mean
2574290|NCT02484807|Secondary|Clinical Relevance 6 Minute Walking Distance|"Changes of medication levels after adjustment of combination therapy if clinically indicated~correlation with clinical routine parameters indicating clinical disease status"|baseline vs. measurement 3-6 months after switch||||meters||Standard Deviation|Mean
2574291|NCT02484807|Secondary|Impact of Medication Adjustment|"Change of medication serum levels after clinically indicated medication adaptation in patients who received Bosentan + Sildenafil in the beginning and changed the ERA to Macitentan~change of mean levels ± standard deviation~frequency of borderline medication serum levels or medication levels out of the therapeutic window The expected mean concentration ranges (MOM) refer to data extracted from published plasma concentration-time profiles measured during monotherapy with sildenafil, tadalafil, bosentan, and ambrisentan and served as comparative values. Each individually measured drug concentration was set in proportion to the expected mean concentration and expressed as a multiple of the expected mean (MoM), with values <1 denoting lower and values >1 higher values than the expected mean."|baseline vs. measurement 3-6 months after switch|20 of 39 patients receiving bosentan /sildenafil were switched to macitentan. sildenafil concentrations were compared before and after switch.|||MOM||Standard Deviation|Mean
2574292|NCT02484807|Primary|Characterisation of Medication Levels|"comparison of different combination treatment arms (mean ± standard deviation), measurement of endothelin receptor antagonist plasma concentrations and PDE-5I plasma concentrations, results given es multiple of the expected mean plasma concentration (MOM). Due to technical setup measurement of plasma concentrations of macitentan was not possible.~The expected mean concentration ranges (MOM) refer to data extracted from published plasma concentration-time profiles measured during monotherapy with sildenafil, tadalafil, bosentan, and ambrisentan and served as comparative values. Each individually measured drug concentration was set in proportion to the expected mean concentration and expressed as a multiple of the expected mean (MoM), with values <1 denoting lower and values >1 higher values than the expected mean."|baseline vs. measurement after 3-6 months||||MOM||Standard Deviation|Mean
2574293|NCT02484729|Secondary|Renal Clearance of Drug From Plasma [CLR (0-48)]|To assess urine pharmacokinetic parameters following single ascending doses of AZD9977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||L/h||Standard Deviation|Mean
2574294|NCT02484729|Secondary|Fraction Excreted Unchanged in Urine[Fe (0-48)]|To assess percentage of the total drug excreted in the urine that was unchanged following single ascending doses of AZD9977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||Percentage||Standard Deviation|Mean
2574295|NCT02484729|Secondary|Cumulative Amount of Unchanged Drug Excreted Into Urine [Ae (0-48)]|To assess urine pharmacokinetic parameters following single ascending doses of AZD9977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||nmol||Standard Deviation|Mean
2574296|NCT02484729|Secondary|Apparent Volume of Distribution (Vz/F)|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||L||Standard Deviation|Mean
2574297|NCT02484729|Secondary|Apparent Clearance (CL/F)|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||L/h||Standard Deviation|Mean
2574298|NCT02484729|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t1/2λz)|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||Hour (h)||Standard Deviation|Mean
2574299|NCT02484729|Secondary|Time to Maximum Observed Plasma Concentration (t Max)|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||Hour (h)||Full Range|Median
2574300|NCT02484729|Secondary|Observed Maximum Concentration (Cmax)|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2574301|NCT02484729|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte concentrationAUC(0-t)|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||h.nmol/L||Geometric Coefficient of Variation|Geometric Mean
2574302|NCT02484729|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Zero Extrapolated to Infinity.|To assess plasma pharmacokinetic parameters following single ascending doses of AZD977|Pre-dose and post-dose upto 48 hrs|The PK analysis set for Part A consisted of all subjects in the safety analysis set who received one dose of AZD9977 and had evaluable PK data. The PK analysis set for Part B consisted of all subjects in the safety analysis set who received at least one dose of AZD9977 and had evaluable PK data in at least one period.|||h.nmol/L||Geometric Coefficient of Variation|Geometric Mean
2574303|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Urinalysis|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||Number of participants|||Number
2574304|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Clinical Chemistry|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||Number of participants|||Number
2574305|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Hematology|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||Number of participants|||Number
2574306|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Changes in Blood Pressure|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||Number of Participants|||Number
2574307|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing the Number of Subjects With Adverse Events|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||Number of Participants|||Number
2574308|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Number of Participants With Clinically Significant Trends in Cardiac Telemetry|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 4 days, i.e. on the day before each dosing and for 24 hours after each dosing|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||Number of Participants|||Number
2574309|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Trends in 12-lead Electrocardiograms|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||Number of participants|||Number
2574310|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing Number of Participants With Clinically Significant Pulse Rate|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||Number of Participants|||Number
2574311|NCT02484729|Primary|Safety and Tolerability of AZD9977 by Assessing the Percentage of Participants With Adverse Events|To assess the safety and tolerability of single ascending doses of AZD9977|For up to 45 days, i.e. from Screening to Follow-up|All subjects who received at least one dose of IMP and for whom any safety post-dose data were available were included in the safety analysis for the study.|||percentage of participants|||Number
2574312|NCT02484651|Secondary|PQRS Satisfaction Results at Day 3 After Surgery|Patient satisfaction with anesthetic care rated as: Not satisfied, A little satisfied, Moderately satisfied ,Satisfied, Totally Satisfied|3rd day after surgery|4 patients did not complete the questionnaire on the 3rd day, since they did not pick up the phone.|||Participants|||Count of Participants
2574313|NCT02484651|Secondary|PQRS Results at 15 and 40 Minutes After Surgery (Taking Into Account the Patient Baseline Values of the PQRS Test Done on the Preanesthetic Visit)|PQRS(Post-operative Quality Recovery Scale) recovery rate at 15 minutes post surgery and PQRS recovery rate at 40 minutes post surgery. Recovery is defined as returning to PQRS baseline values.|15 and 40 minutes after surgery|"10 patients were not able to complete the PQRS test at 15 minutes, since they were not able to communicate or understand the questions.~1 patient was not able to complete the PQRS test at 15 and 40 minutes due to problems in the vocal cords."|||Participants|||Count of Participants
2574314|NCT02484651|Primary|Required Effect-site Concentrations of Propofol and Remifentanil|"Mean effect-site concentration of propofol required during maintenance of anesthesia (using target controlled infusion).~Mean effect-site concentration of remifentanil required during maintenance of anesthesia (using target controlled infusion)."|Maintenance of anesthesia, an average of 130 minutes||||ng/ml||Standard Deviation|Mean
2574315|NCT02484651|Primary|BIS Signal Variability Using the Measured Standard Deviation During the Maintenance Phase of Anesthesia|"BIS (Bispetral Index of the EEG) sample standard deviation during the maintenance phase of anesthesia was used as a measure of signal variability, maintenance phase is defined as the time between the first time the BIS signal drops below 60 after loss of consciousness, until the time the BIS signal goes above 60 after the propofol infusion is stopped. BIS signal varies between 0 to 100. BIS values near 100 represent an awake clinical state while 0 denotes the maximal effect an isoelectric EEG. The aim was to maintain the BIS value within a target range of 40 to 60. The higher the BIS sample standard deviation the higher the oscillation around the sample mean."|Maintenance of anesthesia, an average of 130 minutes||||units on a scale||Standard Deviation|Mean
2574316|NCT02484222|Post-Hoc|Number of Participants Who Were Light Consumers of Morphine as Identified by the Fentanyl Test|The number of participants who were light consumers of morphine as identified by the Fentanyl Test，we want to know the accurate of the test.The light consumers are the children of who used total morphine <50 μg/kg.|average 1 hour from extubation||||Participants|||Count of Participants
2574317|NCT02484222|Secondary|Number of Participants With Pulse Oxygen Saturation Less Than 95 Percent||average 1 hour from extubation||||Participants|||Count of Participants
2574318|NCT02484222|Secondary|Post-operative Nausea and Vomiting||average 1 hour from extubation||||Participants|||Count of Participants
2574319|NCT02484222|Primary|Rescue Morphine Requirement||average 1 hour from extubation||||mg||Inter-Quartile Range|Median
2574320|NCT02483975|Secondary|Change From Baseline (Expressed as a Ratio) in 24-hour 6-beta Hydroxycortisol Excretion at the End of the Six Week Treatment Period (Day 42).|The 24 hr urinary 6-beta hydroxycortisol excretion was collected over a 24 hour period on Day 0 and Day 42. Change from baseline in 24- hr urinary 6-beta hydroxycortisol excretion was calculated as a ratio from baseline defined as 24-hr urinary 6-beta hydroxycortisol excretion at Week 6 divided by the baseline 24-hr urinary 6-beta hydroxycortisol excretion. The ratio from baseline was loge transformed prior to analysis. The loge transformed ratio was compared between treatment groups using an analysis of covariance (ANCOVA) model, allowing for the effects of baseline (loge transformed), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between the Least square (LS) means. Using the pooled estimate of variance, 95% Confidence Intervals (CIs) was calculated for the difference. Participants with 24-hr urinary cortisol excretion at baseline and Week 6 were analyzed.|Baseline (Day 0) Day 42|The UC Population.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2574321|NCT02483975|Secondary|Change From Baseline (Expressed as a Ratio) in 24-hour Urinary Cortisol Excretion at the End of the Six Week Treatment Period (Day 42)|The 24 hr urinary cortisol excretion was collected over a 24 hour period on Day 0 and Day 42. Change from baseline in 24- hr urinary cortisol excretion was calculated as a ratio from baseline defined as 24-hr urinary cortisol excretion at Week 6 divided by the baseline 24-hr urinary cortisol excretion. The ratio from baseline was loge transformed prior to analysis. The loge transformed ratio was compared between treatment groups using an analysis of covariance (ANCOVA) model, allowing for the effects of baseline (loge transformed), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between the Least square (LS) means. Using the pooled estimate of variance, 95% Confidence Intervals (CIs) was calculated for the difference. Participants with 24-hr urinary cortisol excretion at baseline and Week 6 were analyzed.|Baseline (Day 0) Day 42|The Urinary Cortisol (UC) Population used consisted of all participants who did not have protocol violations that were considered to affect the urine cortisol endpoint and whose urine samples were not considered to have confounding factors that affect the interpretation of the results.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2574697|NCT02478359|Secondary|Physical Activity|Patients were categorized as being: completely inactive (0 mins/week), insufficiently active (1-149 mins/week) or active, meeting national physical activity recommendations (>150 mins/week) of moderate to vigorous physical activity.|12 months|ITT population|||Participants|||Count of Participants
2574322|NCT02483975|Secondary|Change From Baseline (Expressed as a Ratio) in Area Under the Curve (AUC) 0-24 Hour Serum Cortisol at the End of the Six Week Treatment Period (Day 42).|The blood samples for statistical analysis of area under the curve over the 24 hours (AUC 0-24 hours) endpoints were collected on Day 0 and Day 42 at the indicated time points. The AUC 0-24 hours was calculated using trapezoidal rule. Change from baseline in AUC 0-24 hour was calculated as a ratio from baseline defined as the AUC (0-24 hours) at Week 6 divided by the baseline AUC (0-24 hours) The ratio from baseline was loge transformed prior to analysis. The loge transformed ratios were compared between treatment groups as treatment ratios using an analysis of covariance (ANCOVA) model, allowing for the effects of baseline (loge transformed), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between the Least square (LS) means. Using the pooled estimate of variance, 95% Confidence Intervals (CIs) was calculated for the difference. Par. with SC weighted mean (0-24hr) calculated at baseline and Week 6 were analyzed|Baseline and Week Baseline, Day 0 (Predose, 2hr, 4hr, 8hr, 12hr, 16hr and 24hr) and Day 42 (0hr, 2hr, 4hr, 8hr, 16hr and 24hr)|The SC population|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2574323|NCT02483975|Primary|Change From Baseline (Expressed as a Ratio) in 0-24 Hour Weighted Mean Serum Cortisol at the End of the Six Week Treatment Period (Day 42) in SC Population|The blood samples for statistical analysis of serum cortisol (SC) endpoints were collected on D0 and D42 at indicated time points. The weighted mean was calculated by dividing the area under curve (AUC) over the 24-hr time period by time period. Change from Baseline in 0-24 hr weighted mean SC was calculated as a ratio from baseline defined as SC weighted mean (0-24 hrs) at Wk 6 divided by the baseline SC weighted mean (0-24 hrs). The ratio as treatment ratios, using an analysis of covariance (ANCOVA) model, allowing for the effects of baseline (loge transformed from baseline was loge transformed prior to analysis. The loge transformed ratios were compared between treatment groups), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between Least square (LS) means. Using the pooled estimate of variance, 95% CIs) was calculated for the difference.|Baseline, Day 0 (Predose, 2hr, 4hr, 8hr, 12hr, 16hr and 24hr) and Day 42 (0hr, 2hr, 4hr, 8hr, 16hr and 24hr)|SC Population consisted of all par. in the ITT pop who did not have protocol violations that considered to affect the SC endpoint and whose serum samples were not considered to have confounding factors that would affect the interpretation of results. Par. with SC weighted mean (0-24 hr) calculated at baseline and Wk 6 were analyzed.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2574324|NCT02483975|Primary|Change From Baseline (Expressed as a Ratio) in 0-24 Hour Weighted Mean Serum Cortisol at the End of the Six Week Treatment Period (D 42) in Intention-to-treat (ITT) Population|The blood samples for statistical analysis of serum cortisol (SC) endpoints were collected on D 0 and D 42 at the indicated time points. The weighted mean was calculated by dividing the area under the curve (AUC) over the 24-hour (hr) time period by the time period. Change from Baseline in 0-24 hr weighted mean SC was calculated as a ratio from Baseline defined as the SC weighted mean (0-24 hours) at Week 6 divided by the Baseline SC weighted mean (0-24 hours).The ratio from Baseline was loge transformed prior to analysis. The loge transformed ratios were compared between treatment groups as treatment ratios, using an analysis of covariance (ANCOVA) model, allowing for the effects of Baseline (loge transformed), age, sex and region. Treatment ratios for comparison was calculated by back-transforming the difference between the Least square (LS) means. Using the pooled estimate of variance, 95% Confidence Intervals (CIs) was calculated for the difference.|Baseline, D 0 (Pre-dose, 2hr, 4hr, 8hr, 12hr, 16hr and 24hr) and Day 42 (0hr, 2hr, 4hr, 8hr, 16hr and 24hr)|ITT Population (pop) comprised of all randomized par. who received at least one dose of study medication. Randomized par. were assumed to have received study medication unless definitive evidence to the contrary exists. Par. with SC weighted mean (0-24 hr) calculated at Baseline and Week 6 were analyzed.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2574325|NCT02483611|Secondary|HR - M7f (Heart Rate in the Moment 7f)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 90 minutes after the traqueal intubation. This time point was named as moment '7f'.|This measure of heart rate was performed 90 minutes after the traqueal intubation||||beats/min||Inter-Quartile Range|Median
2574326|NCT02483611|Secondary|HR - M7e (Heart Rate in the Moment 7e)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 75 minutes after the traqueal intubation. This time point was named as moment '7e'.|This measure of heart rate was performed 75 minutes after the traqueal intubation||||beats/min||Inter-Quartile Range|Median
2574327|NCT02483611|Secondary|HR - M7d (Heart Rate in the Moment 7d)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 60 minutes after the traqueal intubation. This time point was named as moment '7d'.|This measure of heart rate was performed 60 minutes after the traqueal intubation||||beats/min||Standard Deviation|Mean
2574328|NCT02483611|Secondary|HR - M7c (Heart Rate in the Moment 7c)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 45 minutes after the traqueal intubation. This time point was named as moment '7c'.|This measure of heart rate was performed 45 minutes after the traqueal intubation||||beats/min||Standard Deviation|Mean
2574329|NCT02483611|Secondary|HR - M7b (Heart Rate in the Moment 7b)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 30 minutes after the traqueal intubation. This time point was named as moment '7b'.|This measure of heart rate was performed 30 minutes after the traqueal intubation||||beats/min||Standard Deviation|Mean
2574330|NCT02483611|Secondary|HR - M7a (Heart Rate in the Moment 7a)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as 15 minutes after the traqueal intubation.This time point was named as moment '7a'.|This measure of heart rate was performed 15 minutes after the traqueal intubation||||beats/min||Standard Deviation|Mean
2574768|NCT02476994|Secondary|Clinical Laboratory Tests||Up to 90 Days|Due to early termination of the study, no formal analysis was conducted.||||||
2574331|NCT02483611|Secondary|MAP - M7f (Mean Arterial Pressure in the Moment 7f)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 90 minutes after the traqueal intubation. This time point was named as moment '7f'.|This measure of average blood pressure was performed 90 minutes after the traqueal intubation||||mmHg||Inter-Quartile Range|Median
2574332|NCT02483611|Secondary|MAP - M7e (Mean Arterial Pressure in the Moment 7e)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 75 minutes after the traqueal intubation. This time point was named as moment '7e'.|This measure of average blood pressure was performed 75 minutes after the traqueal intubation||||mmHg||Inter-Quartile Range|Median
2574333|NCT02483611|Secondary|MAP - M7d (Mean Arterial Pressure in the Moment 7d)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 60 minutes after the traqueal intubation. This time point was named as moment '7d'.|This measure of average blood pressure was performed 60 minutes after the traqueal intubation||||mmHg||Inter-Quartile Range|Median
2574334|NCT02483611|Secondary|MAP - M7c (Mean Arterial Pressure in the Moment 7c)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 45 minutes after the traqueal intubation. This time point was named as moment '7c'.|This measure of average blood pressure was performed 45 minutes after the traqueal intubation||||mmHg||Standard Deviation|Mean
2574335|NCT02483611|Secondary|MAP - M7b (Mean Arterial Pressure in the Moment 7b)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 30 minutes after the traqueal intubation. This time point was named as moment '7b'.|This measure of average blood pressure was performed 30 minutes after the traqueal intubation||||mmHg||Inter-Quartile Range|Median
2574336|NCT02483611|Secondary|MAP - M7a (Mean Arterial Pressure in the Moment 7a)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as 15 minutes after the traqueal intubation. This time point was named as moment '7a'.|This measure of average blood pressure was performed 15 minutes after the traqueal intubation||||mmHg||Inter-Quartile Range|Median
2574337|NCT02483611|Secondary|HR - M6 (Heart Rate in the Moment 6)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as one minute after the tracheal intubation. This time point was named as moment '6'.|This measure of heart rate was performed one minute after the tracheal intubation||||beats/min||Standard Deviation|Mean
2574338|NCT02483611|Secondary|HR - M5 (Heart Rate in the Moment 5)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as immediately before the tracheal intubation. This time point was named as moment '5'.|This measure of heart rate was performed immediately before the tracheal intubation||||beats/min||Standard Deviation|Mean
2574339|NCT02483611|Secondary|HR - M4 (Heart Rate in the Moment 4)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as in the end of the study solutions infusion. This time point was named as moment '4'.|This measure of heart rate was performed five minutes after M3 (in the end of the X and Y solutions infusion)||||beats/min||Standard Deviation|Mean
2574340|NCT02483611|Secondary|HR - M3 (Heart Rate in the Moment 3)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution). This time point was named as moment '3'.|This measure of heart rate was performed immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution)||||beats/min||Standard Deviation|Mean
2574341|NCT02483611|Secondary|HR - M2 (Heart Rate in the Moment 2)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The heart rate was recorded and annotated at various times such as in the moment immediately before the anesthesia induction. This time point was named as moment '2'.|This measure of heart rate was performed immediately before induction of anesthesia||||beats/min||Standard Deviation|Mean
2574342|NCT02483611|Secondary|HR - M1 (Heart Rate in the Moment 1)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The measure of heart rate was recorded and annotated at various times such as in the arrival of the patient in the operating room. This time point was named as moment '1'.|This measure of heart rate was performed when the patient arrived in the operating room||||beats/min||Standard Deviation|Mean
2574343|NCT02483611|Secondary|MAP - M6 (Mean Arterial Pressure in the Moment 6)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as one minute after the tracheal intubation. This time point was named as moment '6'.|This measure of average blood pressure was performed one minute after the tracheal intubation||||mmHg||Inter-Quartile Range|Median
2574344|NCT02483611|Secondary|MAP - M5 (Mean Arterial Pressure in the Moment 5)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as immediately before the tracheal intubation. This time point was named as moment '5'.|This measure of average blood pressure was performed immediately before the tracheal intubation||||mmHg||Inter-Quartile Range|Median
2574345|NCT02483611|Secondary|MAP - M4 (Mean Arterial Pressure in the Moment 4)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the end of the study solutions infusion.This time point was named as moment '4'.|This measure of average blood pressure was performed five minutes after M3 (in the end of the X and Y solutions infusion)||||mmHg||Inter-Quartile Range|Median
2574346|NCT02483611|Secondary|MAP - M3 (Mean Arterial Pressure in the Moment 3)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution). This time point was named as moment '3'.|This measure of average blood pressure was performed immediately before the start of the infusion of the solution X (magnesium sulfate or isotonic solution) and Y solution (lidocaine or isotonic solution)||||mmHg||Standard Deviation|Mean
2574347|NCT02483611|Secondary|MAP - M2 (Mean Arterial Pressure in the Moment 2)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the moment immediately before the anesthesia induction. This time point was named as moment '2'.|This measure of average blood pressure was performed immediately before induction of anesthesia||||mmHg||Standard Deviation|Mean
2574348|NCT02483611|Secondary|MAP - M1 (Mean Arterial Pressure in the Moment 1)|In the operating room, patients were cardiovascular, respiratory and body temperature monitored through the Dixtal 2020. The mean blood pressure was recorded and annotated at various times such as in the arrival of the patient in the operating room. This time point was named as moment '1'.|This measure of average blood pressure was performed when the patient arrived in the operating room||||mmHg||Standard Deviation|Mean
2574349|NCT02483611|Primary|Spontaneous Recovery (T4/T1=90%)|"Spontaneous recovery is the elapsed time for the recovery of the TOF (T4 / T1) response to 90% of the original after infusion of cisatracurium.~This outcome measure was presented in minutes."|The participants were followed during the anesthetic - surgical procedure||||minutes||Standard Deviation|Mean
2574350|NCT02483611|Primary|Total Duration (Dur95%)|"The total duration is the elapsed time for T1 recovery of the response to reach 95% of the initial after the infusion of cisatracurium.~This outcome measure was presented in minutes."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value < 0.05)|||minutes||Standard Deviation|Mean
2574351|NCT02483611|Primary|Final Recovery Index|"The final recovery index is the elapsed time between the T1 recovery = 25% (Dur25%) and T4 / T1 = 80% (TOF = 80%) after the infusion of cisatracurium.~This outcome measure was presented in minutes."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value < 0.05)|||minutes||Standard Deviation|Mean
2574352|NCT02483611|Primary|Recovery Index|"The recovery index is the elapsed time between the T1 recovery =25% (Dur25%) and T1 =75% (Dur75%) after the infusion of cisatracurium.~This outcome meansure was presented in minutes."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value < 0.05)|||minutes||Standard Deviation|Mean
2574353|NCT02483611|Primary|Clinical Duration|"The clinical duration is the elapsed time for T1 recovery = 25% (Dur25%) of the original value of T1 after the infusion of cisatracurium.~This outcome meansure was presented in minutes."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by Kruskal-Wallis test. When differences were found between the groups, we used the Dunn test for multiple comparisons (p value < 0.05)|||minutes||Inter-Quartile Range|Median
2574354|NCT02483611|Primary|Latency|"The latency is computed as the elapsed time to reduce the response of T1 to 5% of the initial contraction force after the infusion of cisatracurium.~This outcome meansure was presented in seconds."|Participants were followed during the anesthetic - surgical procedure, an average of 90 minutes|The sample size was calculated with a power of 80% to detect differences of 20% in the timing of clinical onset and the duration of NMB. This pharmacodynamic variable was compared between the groups by analysis of variance (Anova one way) and Tukey post-hoc test (p value < 0.05)|||seconds||Standard Deviation|Mean
2574355|NCT02483585|Secondary|Number of Participants Who Developed Antibodies to Erenumab|"Blood samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against erenumab. Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based bioassay to determine neutralizing activity against erenumab (Neutralizing Antibody Assay).~Developing antibody incidence indicates participants with a negative or no result at baseline and a positive result at any time post-baseline.~If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.~Transient indicates a negative result at the participant's last time point tested, for those participants with a positive binding/neutralizing result post-baseline."|Baseline (the period prior to the first dose erenumab 70 mg) and post-baseline (the period after the first dose of erenumab 70 mg until 12 weeks after last dose, up to 48 weeks total)|Participants who received at least one dose of erenumab and with post-baseline data are included in the analysis.|||Participants|||Count of Participants
2574361|NCT02483585|Primary|Change From Baseline in Monthly Migraine Days at Week 12|"A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura.~The change from baseline in monthly migraine days was calculated as the number of migraine days during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine days during the 4-week baseline phase."|4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set which includes participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in monthly migraine days in the double-blind treatment phase.|||migraine days / month||Standard Error|Least Squares Mean
2574356|NCT02483585|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4, where:~Grade 1 = Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 = Life-threatening consequences; urgent intervention indicated Grade 5 = Death related to AE."|From first dose of study drug up to 12 weeks after the last dose. The double-blind treatment phase was 12 weeks and the open-label treatment phase was 28 weeks.|For the double-blind treatment phase adverse events were analyzed for all randomized participants who received at least one dose of study drug. For the open-label treatment phase adverse events were analyzed for all participants who received at least one dose of study drug in the open-label treatment phase.|||Participants|||Count of Participants
2574357|NCT02483585|Secondary|Percentage of Participants With at Least a 5-Point Reduction From Baseline in Average Impact on Physical Impairment Domain Score Measured by MPFID at Week 12|"The Migraine Physical Function Impact Diary (MPFID) is a self-administered 13-item instrument measuring physical functioning. It has two domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and one stand-alone global question. Participants completed the MPFID daily in an electronic diary based on the past 24 hours. Participants responded to each item on a 5-point scale, with difficulty items ranging from Without any difficulty (1) to Unable to do (5) and frequency items ranging from None of the time (1) to All of the time (5). For each domain, the scores were calculated as the sum of the responses and rescaled to 0 - 100, with higher scores representing greater impact of migraine.~Achievement of at least a 5 point reduction from baseline in the monthly average domain score was calculated as (monthly average domain score during the last 4 weeks of the 12-week double-blind treatment phase - baseline monthly average domain score) was ≤ -5."|4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set including participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in MPFID average impact on physical impairment domain score in the double-blind treatment phase. Participants with missing post-baseline data were counted as non-responders.|||percentage of participants|||Number
2574358|NCT02483585|Secondary|Percentage of Participants With at Least a 5-point Reduction From Baseline in Average Impact on Everyday Activities Domain Score Measured by MPFID at Week 12|"The Migraine Physical Function Impact Diary (MPFID) is a self-administered 13-item instrument measuring physical functioning. It has two domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and one stand-alone global question. Participants completed the MPFID daily in an electronic diary based on the past 24 hours. Participants responded to each item on a 5-point scale, with difficulty items ranging from Without any difficulty (1) to Unable to do (5) and frequency items ranging from None of the time (1) to All of the time (5). For each domain, the scores were calculated as the sum of the responses and rescaled to 0 - 100, with higher scores representing greater impact of migraine.~Achievement of at least a 5 point reduction from baseline in the monthly average domain score was calculated as (monthly average domain score during the last 4 weeks of the 12-week double-blind treatment phase - baseline monthly average domain score) was ≤ -5."|4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set including participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in MPFID average impact on everyday activities domain score in the double-blind treatment phase. Participants with missing post-baseline data were counted as non-responders.|||percentage of participants|||Number
2574359|NCT02483585|Secondary|Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days at Week 12|"Monthly acute migraine-specific medication treatment days is the number of days on which migraine specific medications were used between monthly doses of study drug. Migraine-specific medications includes two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications.~The change from baseline in monthly acute migraine-specific treatment days was calculated as the number of migraine-specific treatment days during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine-specific treatment days during the 4-week baseline phase."|4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set which includes participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in monthly acute migraine-specific treatment days in the double-blind treatment phase.|||acute migraine treatment days / month||Standard Error|Least Squares Mean
2574360|NCT02483585|Secondary|Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Week 12|"A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the last 4 weeks of double-blind treatment.~At least a 50% reduction from baseline in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the last 4 weeks of the 12-week double-blind treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%."|4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set which includes participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in monthly migraine days in the double-blind treatment phase. Participants with missing data at week 12 were counted as non-responders.|||percentage of participants|||Number
2574373|NCT02483416|Secondary|Number of Calls Made by the Patients to Their General Practitioner During the 3-month Follow-up.|Number of calls made by the patients to their general practitioner during the 3-month follow-up is presented|D30, D60 and D90|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)|||Participants|||Number
2574769|NCT02476994|Secondary|Adverse Events and Serious Adverse Events||Up to 30 Days After Subject's Last Study Treatment|Due to early termination of the study, no formal analysis was conducted.||||||
2574362|NCT02483572|Secondary|Rate of Destructive Behavior After Treatment, Following Longer Wait Period (Wait-list Control Group Only)|After measuring the control group participant's rate of destructive behavior after approximately 4 months, the investigators will implement FCT treatment and assess the rate of destructive behavior following the control group participant's successful treatment (approximately 32 weeks following initial baseline). These outcome measures may demonstrate that destructive behavior exhibited by the wait-list control participants only reduces to clinically significant levels following FCT treatment, rather than the passage of time.|End of treatment, following wait period (approximately 32 weeks)|Only one participant in the waitlist-control condition completed the study. We analyzed the caregiver-implemented treatment sessions for the child who completed the study.|||responses per minute||Full Range|Mean
2574363|NCT02483572|Secondary|Rate of Functional Communication Responses After Treatment, Following Longer Wait Period (Wait-list Control Group Only)|After measuring the control group participant's rate of functional communication responses after approximately 4 months, the investigators will implement FCT treatment and assess the rate of functional communication responses following the control group participant's successful treatment (approximately 32 weeks following initial baseline). These outcome measures may demonstrate that functional communication responses exhibited by the wait-list control participants only increase to clinically significant levels following FCT treatment, rather than the passage of time.|End of treatment, following wait period (approximately 32 weeks)|We completed the study with one child assigned to the waitlist-control condition.|||responses per minute||Full Range|Mean
2574364|NCT02483572|Secondary|Rate of Functional Communication Responses (FCRs) After Treatment or Wait Period|The investigators will measure the rate of functional communication responses (FCRs) following successful treatment when implemented by participants' caregivers. Participants assigned to the wait-list control group will have their rate of FCRs assessed at the end of the wait period, prior to implementing treatment, to detect any changes in rate of FCRs due to the passage of time.|After treatment or initial wait period (approximately 16 weeks)|We withdrew both participants assigned to FCT. We completed the study with only one child assigned to the waitlist-control condition.|||responses per min||Full Range|Mean
2574365|NCT02483572|Primary|Rate of Destructive Behavior After Treatment or Initial Wait Period|The investigators will measure the rate of destructive behavior following successful treatment when implemented by participants' caregivers. Participants assigned to the wait-list control group will have their rate of destructive behavior assessed at the end of the wait period, prior to implementing treatment, to detect any changes in rate of destructive behavior due to the passage of time.|After treatment or initial wait period (approximately 16 weeks)|We did not collect these posttest data because subjects were withdrawn prior to the posttest period (e.g., due to relocation).|||responses per min||Full Range|Mean
2574366|NCT02483533|Primary|Evaluation of a 12-month Post-treatment, Non-interventional, Observational Period to Evaluate the Safety and Duration of Clinical Effects of LIPO-202.|Subjects who report an improvement of a least 1-point (grade) on the patient global abdominal perception scale and the photonumeric scale.|1 Year|Lack of efficacy - not completed. Study was conducted by Neothetics Inc. and during a company merger with Evofem, no study data was provided. All efforts to locate this data have been exhausted, there is no longer access to this data to be reported.||||||
2574367|NCT02483533|Primary|Evaluation of the Post-treatment Duration of Clinical Effect of LIPO-202. Photonumeric Score and Global Abdominal Perception Score.|Measured by change in clinician reported photonumeric score and change in patient reported global abdominal perception score. Patient-rated changes in amount of bulging or flatness of their belly using the 5-point scale provided as pictures where zero is flat and five is big bulge.|1 Year|Lack of efficacy - not completed. Study was conducted by Neothetics Inc. and during a company merger with Evofem, no study data was provided. All efforts to locate this data have been exhausted, there is no longer access to this data to be reported.||||||
2574368|NCT02483416|Secondary|Number of Adverse Events (AEs), of AEs of Grade ≥ 3, of SAEs Related to the Oral Biological Therapy and Number of AEs Related to the Oral Targeted Therapy Which Causes Temporary or Definitive Discontinuation of the Treatment or Dose Reduction.|Number of participants with Adverse events AEs, of AEs of grade ≥ 3, of serious adverse events (SAEs) related to the oral biological therapy and Number of AEs related to the oral targeted therapy which causes temporary or definitive discontinuation of the treatment or dose reduction are presented|up to 3 months|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- Observed cases|||Participants|||Number
2574369|NCT02483416|Secondary|Number of Calls Between the General Practitioners and the Medical Teams During the 3-month Follow-up|Number of calls between the general practitioners and the medical teams during the 3-month follow-up is presented|D30, D60, D90|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- Observed cases|||Participants|||Number
2574370|NCT02483416|Secondary|Number of Calls Made by the Medical Team to Their Patient During the 3-month Follow-up|Number of calls made by the medical team to their patient during the 3-month follow-up is presented|D30, D60 and D90|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)|||Participants|||Number
2574371|NCT02483416|Secondary|Number of Calls Made by the Patients to Their Medical Team During the 3-month Follow-up|Number of calls made by the patients to their medical team during the 3-month follow-up is presented|D30, D60 and D90|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)|||Participants|||Number
2574372|NCT02483416|Secondary|Number of Calls Made by the General Practitioner to the Patient During the 3-month Follow-up.|Number of calls made by the general practitioner to the patient during the 3-month follow-up is presented|D30, D60 and D90|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)|||Participants|||Number
2574374|NCT02483416|Secondary|VAS Score (0-10) for Overall Pharmacist Satisfaction With the Level of Patient Care at D90 (Only for the Patients With 'Remote Additional Personalised Nurse-led Follow-up).|"VAS score (0-10) for overall pharmacist satisfaction with the level of patient care at D90 (only for the patients with 'remote additional personalised nurse-led follow-up)(Overall pharmacist satisfaction) is presented.~VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction."|D90|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)|||scores on a scale||Full Range|Median
2574375|NCT02483416|Secondary|VAS Score (0-10) for Overall General Practitioner Satisfaction With the Level of Patient Care at D90 (Only for the Patients With 'Remote Additional Personalised Nurse-led Follow-up)|"VAS score (0-10) for overall general practitioner satisfaction with the level of patient care at D90 (only for the patients with 'remote additional personalised nurse-led follow-up) (Overall general practitioner satisfaction) is presented.~VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction."|D90|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)|||scores on a scale||Full Range|Median
2574376|NCT02483416|Secondary|VAS Score (0-10) for Overall Investigator Satisfaction With the Level of Patient Care at D90|"VAS score (0-10) for overall investigator satisfaction with the level of patient care at D90 (Overall investigator satisfaction) is presented.~VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction."|D90|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)|||scores on a scale||Full Range|Median
2574377|NCT02483416|Secondary|Number of Unplanned Visits to the General Practitioner During the 3-month Follow-up|Number of participants with unplanned visits to the general practitioner during the 3-month follow-up is presented|D30, D60 and D90|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)|||Participants|||Number
2574378|NCT02483416|Secondary|Number of Unplanned Visits to a Specialist, Whatever is His Specialty, Other Than the Investigator During the 3-month Follow-up.|Number of participants with unplanned visits to a specialist, whatever is his specialty, other than the investigator during the 3-month follow-up is presented|D30, D60 and D90|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)|||Participants|||Number
2574379|NCT02483416|Secondary|Number of Unplanned Visits to the Investigator During the 3-month Follow-up|Number of participants with unplanned visits to the investigator during the 3-month follow-up are presented|D30, D60 and D90|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)|||Participants|||Number
2574380|NCT02483416|Secondary|Duration of Unplanned Hospitalizations (Related to the Treatment)) During the 3-month Follow-up.|Duration of unplanned hospitalizations (related to the treatment) during the 3-month follow-up are presented|D30, D60 and D90|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)|||days||Full Range|Median
2574381|NCT02483416|Secondary|Number of Unplanned Hospitalizations (Related to the Treatment) During the 3-month Follow-up|Number of participants with unplanned hospitalizations (related to the treatment) during the 3-month follow-up is presented|D30, D60, D90|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- Observed cases|||Participants|||Number
2574382|NCT02483416|Secondary|Number of Emergency Admissions (Related to the Treatment) During the 3-month Follow-up.|Number of participants with emergency admissions (related to the treatment) during the 3-month follow-up are presented|Day30 (D30), Day60 (D60) and Day90 (D90)|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)|||Participants|||Number
2574383|NCT02483416|Secondary|Change in Quality of Life Questionnaire Functional Assessment of Cancer Therapy Lung (FACT-L) Score Between D30 and D0, Between D90 and D30 and Between D90 and D0|The patients' quality of life was evaluated with the FACT-L questionnaire. This questionnaire explores 4 dimensions of well-being: physical, social and emotional. These items are completed by 9 questions specific to lung cancer. Subscale scores are added to obtain total score. Scores obtained with this questionnaire range between 0 and 136. The higher the score the better the quality of life.|Day0 (D0), Day30 (D30) and Day90 (D90)|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)|||scores on a scale||Full Range|Median
2574770|NCT02476994|Secondary|Vital Signs||Up to 90 Days|Due to early termination of the study, no formal analysis was conducted.||||||
2574384|NCT02483416|Secondary|Visual Analogue Scale (VAS) Score (0-10) for Overall Patient Satisfaction With the Level of Care (Information, Advice) at D90.|VAS scores will be presented in the form of a horizontal ungraduated line of 10 centimeters (cm), with the following extremities: left, 'completely unsatisfied' and right, 'very satisfied'. The number of points (0 to 10) obtained in VAS corresponds to the distance (cm) between the left extremity of the line and the mark placed on the line by the patient, investigator, general practitioner, or pharmacist to assess patient's level of satisfaction.|3 months|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)|||scores on a scale||Full Range|Median
2574385|NCT02483416|Secondary|Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following Patient Decision.|"Cumulated dose of oral targeted therapy not taken due to temporary or definitive interruption following patient decision.~No patient without therapy following patient decision"|3 months|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)|||milligram (mg)||Standard Deviation|Mean
2574386|NCT02483416|Secondary|Cumulated Dose of Oral Targeted Therapy Not Taken Due to Dose Reduction Following Patient Decision.|Cumulated dose of oral targeted therapy not taken due to dose reduction following patient decision. No participants with dose reduction.|3 months|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- only participants with dose reduction||||||
2574387|NCT02483416|Secondary|Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Patient Decision.|Cumulated dose of oral targeted therapy not taken (all categories) following patient decision. Cumulated dose not taken in total is missing since no patient without therapy following patient decision|3 months|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- Observed cases||||||
2574388|NCT02483416|Secondary|Cumulated Dose of Oral Targeted Therapy Not Taken Due to Temporary or Definitive Interruption Following the Medical Team Decision.|Cumulated dose of oral targeted therapy not taken due to temporary or definitive interruption following the medical team decision.|3 months|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- Observed cases|||milligram (mg)||Standard Deviation|Mean
2574389|NCT02483416|Secondary|Cumulated Dose of Oral Targeted Therapy Not Taken Due to Dose Reduction Following Decision of the Medical Team.|"Cumulated dose of oral targeted therapy not taken due to dose reduction following decision of the medical team.~There were no participants with dose reduction hence the data is not available."|3 months|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- Observed cases||||||
2574390|NCT02483416|Secondary|Cumulated Dose of Oral Targeted Therapy Not Taken (All Categories) Following Decision of the Medical Team|The cumulated dose (mg) of oral targeted therapy not taken between 2 visits is the sum of the doses (mg) of tablets not taken by the patient. The cumulated dose (mg) of oral targeted therapy not taken during the 3-month follow-up is the sum of the cumulated doses (mg) not taken between 2 visits during the 3-month follow-up.|3 months|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- Observed cases|||milligram (mg)||Full Range|Median
2574391|NCT02483416|Secondary|Score (0-6) Obtained With the Girerd Questionnaire|"Girerd questionnaire is a questionnaire composed of 6 binary questions (yes/no) and is used to assess treatment compliance. The final score obtained is the number of questions to which the patient responded yes. Thus, the score ranges from 0 to 6. A patient will be classified as:~Good compliant with score = 0. Minor non-compliant with score = 1 or 2. Non-compliant with score >2."|at Day 30 (D30), Day 60 (D60) and Day 90 (D90)|Population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- Observed cases|||scores on a scale||Standard Deviation|Mean
2574392|NCT02483416|Primary|The Cumulated Dose Milligram (mg) of Oral Targeted Therapy During the 3-month Follow-up.|The cumulated dose (mg) of oral targeted therapy taken between visits is the sum of the doses (mg) of the tablets taken by the patient. The cumulated dose (mg) of the oral targeted therapy taken during the 3-month follow-up is the sum of the doses (mg) cumulated taken between visits during the 3-month follow-up.|3 months|The primary analysis population will be the population of randomised patients who satisfy the essential inclusion and exclusion criteria, and for whom information is available for the major evaluation criteria (in particular the primary criterion)- Observed cases|||milligram (mg)||Full Range|Median
2574393|NCT02482935|Secondary|Pharmacokinetics: Time to Maximum Concentration (Tmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites||Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period|All participants who received abemaciclib and had evaluable plasma values.|||hours||Full Range|Median
2574394|NCT02482935|Primary|Pharmacokinetics: Maximum Concentration (Cmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites||Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period|All participants who received abemaciclib and had evaluable plasma values.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2574395|NCT02482935|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-inf]) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites||Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period|All participants who received abemaciclib and had evaluable plasma values.|||nanograms x hours/mililiters (ng·h/mL)||Geometric Coefficient of Variation|Geometric Mean
2574397|NCT02482870|Secondary|Cormack-Lehane Score|"Best Cormack-Lehane score (as declared by the laryngoscopist) obtained with both laryngoscopes is recorded.~Cormack-Lehane score is graded according to the following criteria (1 is best, and 4 is worst):~full view of glottis (difficult intubation unlikely)~partial view of glottis (~5% risk of difficult intubation)~partial view of epiglottis, none of glottis seen (~90% risk of difficult intubation)~neither glottis nor epiglottis seen (difficult intubation very likely)"|less than 24 hours||||participants|||Number
2574398|NCT02482870|Secondary|Glottic View Time|"Glottic view time (as defined when the laryngoscopist declared the best Cormack-Lehane score) with each laryngoscope is recorded.~Cormack-Lehane score is obtained by directly assessing the distance between the base of the tongue and the roof of the mouth to predict how diffcult an intubation will be.~It consists of 4 grades:~full view of glottis (difficult intubation unlikely)~partial view of glottis (~5% risk of difficult intubation)~partial view of epiglottis, none of glottis seen (~90% risk of difficult intubation)~neither glottis nor epiglottis seen (difficult intubation very likely)"|less than 24 hours||||seconds||Inter-Quartile Range|Median
2574399|NCT02482870|Secondary|Intubation Time|Successful endotracheal intubation is defined as the endotracheal cuff passing the patient's vocal cords. Time to intubation with each laryngoscope is recorded.|less than 24 hours||||seconds||Inter-Quartile Range|Median
2574400|NCT02482870|Primary|Intubation Success Rate|Endotracheal intubation attempt is defined as entrance of the endotracheal tube into the patient's mouth. Any major change in the alignment of the laryngoscope is defined as another intubation attempt. Successful endotracheal intubation is defined as the endotracheal cuff passing through the patient's vocal cords. Intubation success rate is defined as: 1 / [the number of attempts].|less than 24 hours||||participants|||Number
2574401|NCT02482805|Primary|Salivary Testosterone Levels|Saliva sample taken before posture manipulation and 20 minutes after. Outcome is the change from pre- to post-manipulation in testosterone levels.|Baseline and 20 minutes after posture manipulation||||pg/mL||Standard Deviation|Mean
2574402|NCT02482805|Primary|Subjective Units of Distress Scale (SUDs)|"Peak (max) SUDS ratings (0 to 100 scale) during treatment exposure and 1 week post-treatment exposure.~Peak Subjective Units of Distress Scale (SUDS) is the maximum amount of fear experienced rated on a 0 to 100 point scale, where 0 indicates no anxiety and 100 indicates the maximum level of anxiety."|Scores at 1 week post-treatment|8 individuals did not complete the post-treatment exposure; accordingly the analyses were conducted with only 66 individuals (versus the total sample size of 73) who had complete data.|||units on a scale||Standard Deviation|Mean
2574403|NCT02482805|Primary|LSAS-performance Subscale|"Liebowitz Social Anxiety Scale (LSAS)-Performance Subscale at pre- and 1-week post-treatment.~The Liebowitz Social Anxiety Scale (LSAS) - Performance Subscale is a subscale of a common measure of social anxiety symptom severity. This subscale consists of only 13 (of the total 24) items related to performance situations. Participants rate both their fear (0 to 3) and avoidance (0 to 3) of these 13 situations, where higher scores indicate worse social anxiety severity. The minimum possible score on this subscale is 0 and the maximum possible score is 78."|Scores at 1 week post-treatment|4 individuals did not complete LSAS at post-treatment; accordingly the analyses were conducted with only 69 individuals (versus the total sample size of 73) who had complete data.|||units on a scale||Standard Deviation|Mean
2574404|NCT02482675|Secondary|Arachidonic Acid|Arachidonic acid concentration, calculated as Arachidonic acid AUC from 0-180 minutes|Arachidonic acid area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)||||ug/mL*min||Standard Error|Mean
2574405|NCT02482675|Secondary|8-isoprostaglandin-F2a/Arachidonic Acid|Plasma 8-isoprostaglandin-F2a/Arachidonic acid concentration, calculated as 8-isoprostaglandin-F2a/Arachidonic acid AUC from 0-180 minutes|8-isoprostaglandin-F2a/Arachidonic acid area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)||||(pg/mL)/(ug/mL)*min||Standard Error|Mean
2574406|NCT02482675|Secondary|8-isoprostaglandin-F2a|Plasma 8-isoprostaglandin-F2a concentration, calculated as 8-isoprostaglandin-F2a AUC from 0-180 minutes|8-isoprostaglandin-F2a area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)||||pg/mL*min||Standard Error|Mean
2574407|NCT02482675|Secondary|Cholecystokinin (CCK)|Plasma CCK concentration, calculated as CCK AUC from 0-180 minutes|CCK area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)||||pmol/L*min||Standard Error|Mean
2574408|NCT02482675|Secondary|Insulin|Plasma insulin concentration, calculated as insulin AUC from 0-180 minutes|Insulin area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)||||uIU/mL*min||Standard Error|Mean
2574409|NCT02482675|Secondary|Tetrahydrobiopterin/Dihydrobiopterin (BH4/BH2)|Plasma BH4/BH2 concentration, calculated as BH4/BH2 AUC from 0-180 minutes|Plasma BH4/BH2 concentration area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)||||ratio*min||Standard Error|Mean
2574410|NCT02482675|Secondary|Symmetric Dimethylarginine/Arginine (SDMA/ARG)|Plasma SDMA/arginine concentration, calculated as SDMA/ARG AUC from 0-180 minutes|SDMA/ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)||||(nmol/L)/(umol/L)*min||Standard Error|Mean
2574411|NCT02482675|Secondary|Asymmetric Dimethylarginine/Arginine (ADMA/ARG)|Plasma ADMA/arginine concentration, calculated as ADMA/ARG AUC from 0-180 minutes|ADMA/ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)||||(nmol/L)/(umol/L)*min||Standard Error|Mean
2574412|NCT02482675|Secondary|Arginine (ARG)|Plasma arginine concentration, calculated as ARG AUC from 0-180 minutes|ARG area under the curve for 3 hours (0, 30, 60, 90, 120, 150, 180 minutes) (change from baseline)||||umol/L*min||Standard Error|Mean
2574413|NCT02482675|Secondary|Malondialdehyde (MDA)|Plasma MDA measured as MDA AUC from 0-180 minutes|Area under curve for MDA for three hours (0, 30, 60, 90, 120, 150, 180 min.) (change from baseline)||||umol/L*min||Standard Error|Mean
2574414|NCT02482675|Secondary|Plasma Glucose|Plasma glucose concentration from 0-180 minutes|Area under the curve for glucose for three hours (0, 30, 60, 90, 120, 180 minutes) (change from baseline)||||mg/dL*min||Standard Error|Mean
2574415|NCT02482675|Secondary|Nitrite/Nitrate (NOx)|NOx AUC for 0-180 minutes|Area under curve for nitrite/nitrate for three hours (0, 30, 60, 90, 120, 180 min) (change from baseline)||||umol/L*min||Standard Error|Mean
2574771|NCT02476994|Secondary|Prescribed and Actual (Total Calories From PN and Oral) Nutritional Intake||Up to 90 Days|Due to early termination of the study, no formal analysis was conducted.||||||
2574417|NCT02482610|Secondary|Oxidative Stress Biomarker (Malondialdehyde; MDA)|MDA concentrations evaluated on the basis as change from baseline to calculate MDAarea under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in MDA from 0 min to 180 min (i.e., AUC (MDA 0 min- 0 min, MDA 30 min-0 min, MDA 60 min-0 min, etc)|Area under curve of MDA for three hours (0, 30, 60, 90, 120, 150, 180 min)||||umol/L*min||Standard Error|Mean
2574418|NCT02482610|Secondary|Glucose|Glucose concentrations evaluated on the basis as change from baseline to calculate glucose area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in glucose from 0 min to 180 min (i.e., AUC (glucose 0 min- 0 min, glucose 30 min-0 min, glucose 60 min-0 min, etc)|Area under curve of glucose for three hours (0, 30, 60, 90, 120, 150, and 180 min)||||mg/dL*min||Standard Error|Mean
2574419|NCT02482610|Secondary|Biomarker of Nitric Oxide Homeostasis (NOx)|Biomarker of nitric oxide homeostasis is based on the assessment of total nitrite and nitrate concentrations. Changes relative to baseline were used to calculate area under the curve of total nitric oxide metabolites from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in nitric oxide homeostasis from 0 min to 180 min (i.e., AUC (NOx 0 min- 0 min, NOx 30 min-0 min, NOx 60 min-0 min, etc)|Area under curve of nitrite/nitrate for three hours (0, 30, 60, 90, 120, 150, and 180 min)||||umol/L*min||Standard Error|Mean
2574420|NCT02482610|Primary|Vascular Endothelial Function|Flow mediated dilation (FMD) evaluated on the basis as change from baseline to calculate FMD area under the curve from 0-180 min, i.e. i.e. Area Under the Curve (AUC) of change from baseline in FMD from 0 min to 180 min (i.e., AUC (FMD 0 min- 0 min, FMD 30 min-0 min, FMD 60 min-0 min, etc)|Area under curve of FMD for three hours (0, 30, 60, 90, 120, 150, and 180 min)||||%*min||Standard Error|Mean
2574421|NCT02482571|Secondary|Brain Activity Measured by Blood Oxygenation Level Dependent (BOLD) Signal at Hypoxia|Relative change in water signal intensity from rest to visual stimulation as measured by fMRS (without water suppression) in the primary visual cortex during conditions of hypoxia.|Baseline and Visual Stimulation at 30 seconds|Out of the 17 experimental sessions that were successfully completed, 4 had data of insufficient quality. Therefore, a total of 13 sessions was used for final analyses.|||percentage of signal intensity||Standard Deviation|Mean
2574422|NCT02482571|Secondary|Brain Activity Measured by Blood Oxygenation Level Dependent (BOLD) Signal at Normoxia|Relative change in water signal intensity from rest to visual stimulation as measured by fMRS (without water suppression) in the primary visual cortex during conditions of normoxia.|Baseline and Visual Stimulation at 30 seconds|Out of the 17 experimental sessions that were successfully completed, 4 had data of insufficient quality. Therefore, a total of 13 sessions was used for final analyses.|||percentage of signal intensity||Standard Deviation|Mean
2574423|NCT02482571|Primary|Change in Glutamate Concentration During a Visual Stimulus Measured by Functional MRS at Hypoxia|Relative change in glutamate concentration from rest to visual stimulation as measured by fMRS (with water suppression) in the primary visual cortex during conditions of hypoxia.|Baseline and Visual Stimulation at 4 minutes|Out of the 17 experimental sessions that were successfully completed, 4 had data of insufficient quality. Therefore, a total of 13 sessions was used for final analyses.|||percentage of concentration (micromol/g)||Standard Deviation|Mean
2574424|NCT02482571|Primary|Change in Glutamate Concentration During a Visual Stimulus Measured by fMRS at Normoxia|Relative change in glutamate concentration from rest to visual stimulation as measured by fMRS (with water suppression) in the primary visual cortex during conditions of normoxia.|Baseline and Visual Stimulation at 4 minutes|Out of the 17 experimental sessions that were successfully completed, 4 had data of insufficient quality. Therefore, a total of 13 sessions was used for final analyses.|||percentage of concentration (micromol/g)||Standard Deviation|Mean
2574425|NCT02482428|Secondary|Number of Participants That Had Partial Clearance Rate of at Least 75 Percent Reduction in External Genital Wart (EGW)s Count at End of Treatment (EOT) Week 12 or 16|Number of Participants that had partial clearance rate of at least 75 percent reduction in External Genital Wart (EGW)s count at end of treatment (EOT) Week 12 or 16|End of Treatment (EOT) Week 12 or Week 16|Pharmacodynamics (PD) data sets included all randomized patients For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.|||participants|||Number
2574426|NCT02482428|Primary|Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 30 Weeks|Number of participants with at least one AE/SAE in the category up to 30 weeks|30 weeks|The safety analysis set included all patients that received any study drug. For Safety & Tolerability only the 2 vehicles have separate analysis.|||participants|||Number
2574427|NCT02482428|Primary|Complete Clearance of Disease at Week 14|Number of participants achieving complete clearance of genital warts at Week 14|Week 14|Pharmacodynamics (PD) data sets included all randomized patients For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.|||participants|||Number
2574428|NCT02482298|Other Pre-specified|Number of Major Bleeding or Clinically Relevant Non-major Bleeding Events (Events)|To assess safety and tolerability of 2 different doses of ticagrelor versus placebo in patients with SCD|Baseline through Week 12|The Safety analysis set included all patients who received at least 1 single dose of randomised IP, ticagrelor or placebo, and for whom any post-dose data were available. Patients were analysed according to the actual treatment.|||Number of events|||Number
2574429|NCT02482298|Other Pre-specified|Number of Major Bleeding or Clinically Relevant Non-major Bleeding Events (Patients)|To assess safety and tolerability of 2 different doses of ticagrelor versus placebo in patients with SCD|Baseline through Week 12|The Safety analysis set included all patients who received at least 1 single dose of randomised IP, ticagrelor or placebo, and for whom any post-dose data were available. Patients were analysed according to the actual treatment.|||Number of patients|||Number
2574430|NCT02482298|Secondary|Change in Proportion of Days With Analgesic Use Measured by an eDiary|To assess the efficacy of 2 different doses of ticagrelor versus placebo in reducing the use of analgesics by patients with sickle cell disease.|Baseline through Week 12|The Efficacy analysis set included all randomized patients with at least 1 eDiary record post dose. Patients were analyzed according to their randomized IP.|||Proportion of days with analgesic use||90% Confidence Interval|Least Squares Mean
2574772|NCT02476994|Secondary|Change From Baseline of Hepatic Integrity (ALP, AST, ALT, GGT, Total and Direct Bilirubin)||Up to 90 Days|Due to early termination of the study, no formal analysis was conducted.||||||
2574431|NCT02482298|Secondary|Average of the Daily Worst Pain Values Reported Via eDiary|To determine the efficacy of 2 different doses of ticagrelor versus placebo in reducing the intensity of pain due to sickle cell disease. Intensity of pain was recorded on an 11-point scale where 0 represented no pain and 10 represented the worst pain imaginable.|Baseline through Week 12|The Efficacy analysis set included all randomized patients with at least 1 eDiary record post dose. Patients were analyzed according to their randomized IP.|||Average daily worst pain rating||Standard Deviation|Mean
2574432|NCT02482298|Primary|Change in Proportion of Days With Pain Due to Sickle Cell Disease as Measured by an eDiary|To investigate the efficacy of 2 different doses of ticagrelor versus placebo in reducing the number of days with pain due to sickle cell disease.|Baseline through Week 12|The Efficacy analysis set included all randomized patients with at least 1 eDiary record post dose. Patients were analyzed according to their randomized IP.|||Proportion of days with pain||90% Confidence Interval|Least Squares Mean
2574433|NCT02482233|Secondary|Number of Participants Postoperative Complications (Composite)|by telephone self-report|30-days postop||||Participants|||Count of Participants
2574434|NCT02482233|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|all patients will be asked about adverse events each time they are contacted (day of surgery, 30-days postoperatively, and 8-weeks after randomization), and they will also be able to call to report adverse events to the study team any time during the study.|8 weeks||||Participants|||Count of Participants
2574435|NCT02482233|Secondary|Long-term Smoking Status - Use of Conventional Cigarettes|by self-report (7-day point prevalence)|6 months|those lost assumed to still be smoking|||Participants|||Count of Participants
2574436|NCT02482233|Secondary|Number of Participants With Postoperative Complications (Composite)|by chart review - research assistant or investigator examined notes and investigations postoperatively for complications by telephone self-report - patients were asked open-ended question about whether they experienced any postoperative complications|30-days postop||||Participants|||Count of Participants
2574437|NCT02482233|Secondary|Cotinine Level (Change in)|salivary|day of surgery and 8-weeks||||ng/ml||Standard Deviation|Mean
2574438|NCT02482233|Secondary|Spirometry - FEV1|change in FEV1 (mL) compared to baseline|day of surgery and 8-weeks||||mL||Standard Deviation|Mean
2574439|NCT02482233|Secondary|Spirometry - FEV1/FVC Change|Change in FEV1/FVC from baseline to day of surgery / 8-weeks. FEV1/FVC is expressed in percent. For example, if FEV1/FVC was 75%, 80%, and 85% at baseline, day of surgery and 8-weeks, result is reported as change in FEV1/FVC being +5% and +10% for day of surgery and 8-weeks respectively.|day of surgery and 8-weeks||||percent (change from baseline)||Standard Deviation|Mean
2574440|NCT02482233|Secondary|Number of Participants With Dual Use|use of both regular and e-cigarettes concurrently|on day of surgery and 8-weeks after randomization||||Participants|||Count of Participants
2574441|NCT02482233|Secondary|Smoking Reduction|50% or less regular cigarette use compared to baseline as determined by asking participants to self-report daily cigarette use in cigarettes per day at each time point.|on day of surgery and 8-weeks after randomization||||Participants|||Count of Participants
2574442|NCT02482233|Secondary|Smoking Status 8-weeks After Randomization (Confirmed by Exhaled CO)|by self-report and confirmed by exhaled CO<10ppm - confirmed abstinent|8-weeks|Those lost to follow-up assumed to still be smoking (1 in NRT group). Those who had telephone interview were unable to have exhaled CO verification (n=1 in NRT group, n=2 in END group). Since they were not verified by exhaled CO, they were not considered abstinent.|||Participants|||Count of Participants
2574443|NCT02482233|Secondary|How Likely the Patient Would be to Recommend the Product (E-cigarette or Patch) to Others|"7-point likert scale (strongly disagree to strongly agree)~strongly disagree~disagree~disagree somewhat~neither agree nor disagree~agree somewhat~agree~strongly agree"|8-weeks||||units on a scale out of 7||Inter-Quartile Range|Median
2574444|NCT02482233|Secondary|How Satisfied the Patient Was With the Product (E-cigarette or Patch)|"7-point likert scale (strongly disagree to strongly agree)~strongly disagree~disagree~disagree somewhat~neither agree nor disagree~agree somewhat~agree~strongly agree"|8-weeks||||units on a scale out of 7||Inter-Quartile Range|Median
2574445|NCT02482233|Secondary|Report of How Helpful the Product Was for Quitting|"7-point likert scale (strongly disagree to strongly agree)~strongly disagree~disagree~disagree somewhat~neither agree nor disagree~agree somewhat~agree~strongly agree"|8-weeks||||units on a scale out of 7||Inter-Quartile Range|Median
2574446|NCT02482233|Secondary|Frequency of Use of Product - Number Reporting Use Daily or Most Days|"how often product (e-cigarette or patch) was used (everyday except while hospitalized, most days, a few times a week, once a week, less than once a week, not at all)~Result reported is those that used the product daily or most days"|8-weeks|in-person visit at 8-weeks, or make-up phone call if unavailable in-person|||Participants|||Count of Participants
2574447|NCT02482233|Primary|Smoking Status on the Day of Surgery (48-hour Point-prevalence Abstinence), by Self-report and Confirmed With Exhaled Carbon Monoxide (CO)|"Confirmed abstinent. Abstinence confirmed with exhaled carbon monoxoide <10ppm.~Time Frame depends on date of preadmission clinic visit"|day of surgery (expected average around 1-2 weeks after enrollment/randomization)||||Participants|||Count of Participants
2574448|NCT02482129|Secondary|Number of Subjects With Anti-LME636 Antibodies Present at Each Visit|Serum samples were collected and assessed for anti-LME636 antibodies. Samples collected from subjects in the LME636 dose group were analyzed for anti-LME636 antibodies. For subjects in the dexamethasone group, only the samples collected on Day 1 (ie, prior to the start of treatment) were analyzed for anti-LME636 antibodies.|Day 1, Day 4, Day 8, Day 15, Day 22, Day 29|This analysis population includes all subjects with available immunogenicity data and no protocol deviations with relevant impact on the data (Immunogenicity Set).|||Participants|||Count of Participants
2574449|NCT02482129|Secondary|Mean Serum Concentration of Total LME636 at Each Visit|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. Concentrations below the limit of quantification (BLQ), defined as 0.25 ng/mL, were reported as NA with no imputation for missing data.|Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29|This analysis population includes all subjects who received investigative product (IP) and had at least 1 evaluable serum sample following IP exposure.(Pharmacokinetics Analysis Set). Number Analyzed is the number of subjects with data at visit.|||ng/mL||Standard Deviation|Mean
2574451|NCT02482129|Secondary|Time-to-Response|Time-to-Response was defined as the number of days from baseline to the first scheduled visit when a two-step decrease or more from baseline in AC Cell Grade (as per SUN) was observed. Time-to-Response is reported as number of subjects presenting time-to-response by visit. Only one eye contributed to the analysis.|Baseline (Day 1), Up to Day 15|Per Protocol Analysis Set|||Participants|||Count of Participants
2574452|NCT02482129|Secondary|Mean Change From Baseline in BCVA at Each Visit|Visual Acuity (VA) was measured with the participant's best spectacles or other visual corrective device in place using an ETDRS or Snellen visual acuity chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. Only one eye contributed to the analysis.|Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29|Safety Analysis Set. Number Analyzed is the number of subjects with data at visit.|||letters||Standard Deviation|Mean
2574453|NCT02482129|Secondary|Number of Subjects With IOP Change From Baseline to Last On-Treatment Assessment|IOP was assessed using Goldmann applanation tonometry or Tonopen and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.|Baseline (Day 1), Up to Day 29|Safety Analysis Set|||Participants|||Count of Participants
2574454|NCT02482129|Primary|Number of Subjects With an Increase From Baseline in Dilated Fundus Parameters at Any Post-Treatment Visit|The dilated fundus examination was performed to evaluate the health of the vitreous, optic disc, retinal vessels, macula, and retinal periphery. An increase indicates worsening. Only one eye contributed to the analysis.|Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29|Safety Analysis Set|||participants|||Number
2574455|NCT02482129|Primary|Number of Subjects With Increase From Baseline in Slit Lamp Parameters at Any Post-Treatment Visit|Slit-lamp biomicroscopy (examination) was performed to evaluate the anterior segment of the eye, including lids/lashes, conjunctiva, cornea, anterior chamber (cells and flare), iris, and lens. Ocular signs were categorized as Aqueous Flare, Aqueous Inflammatory Cell Grade, Keratic Precipitates, Lens, Limbal Injection, Status of Lens, Peripheral Anterior Synechia, and Posterior Synechia. An increase indicates worsening. Only one eye contributed to the analysis.|Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29|Safety Analysis Set|||participants|||Number
2574456|NCT02482129|Primary|Mean Intraocular Pressure (IOP) at Each Visit|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry or Tonopen and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.|Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29|Safety Analysis Set. Number Analyzed is the number of subjects with data at visit.|||mmHg||Standard Deviation|Mean
2574457|NCT02482129|Primary|Mean Best Corrected Visual Acuity (BCVA) at Each Visit|Visual Acuity (VA) with the subject's best spectacles or other visual corrective devices was measured using an Early Treatment of Diabetic Retinopathy Study (ETDRS) or Snellen visual acuity chart and reported in letters read correctly. An increase (gain) in letters read indicates improvement. Only one eye contributed to the analysis.|Baseline (Day 1), Day 4, Day 8, Day 15, Day 22, Day 29|This analysis population includes all subjects who received any study drug (Safety Analysis Set). Number Analyzed is the number of subjects with data at visit.|||letters||Standard Deviation|Mean
2574458|NCT02482129|Primary|Number of Responders at Day 15|Response was defined as a two-step decrease or more from baseline in Anterior Chamber (AC) Cell Grade as per Standardization of Uveitis Nomenclature (SUN). Baseline was defined as the measurement taken before drug administration on Day 1. Subjects receiving rescue treatment on or before Day 15 were considered non-responders. Only one eye contributed to the analysis.|Baseline (Day 1), Day 15|This analysis population includes all subjects who received any study drug, had at least 1 post-baseline efficacy assessment, had no critical protocol deviations, and had a valid determination of response status for the primary endpoint (Per Protocol Analysis Set).|||Participants|||Count of Participants
2574459|NCT02481934|Secondary|Number of Participants With Peripheral Blood Monoclonal Protein Reduction or Stabilization|Efficacy will be assessed monthly during NKAE treatment (4 months) by peripheral blood monoclonal protein monitoring. During follow-up, efficacy will be evaluated monthly the first 6 months. After that, quarterly until one year of follow-up.|16 months||||participants|||Number
2574460|NCT02481934|Primary|Number of Participants With Adverse Events During NKAE Treatment|Toxicity will be assessed by adverse events count during NKAE treatment monitoring peripheral blood absolute neutrophil count (cells/μl). Toxicity will be evaluated monthly during NKAE treatment (4 months). During follow-up, it will be assessed monthly the first 6 months. After that, quarterly until one year of follow-up, based on Common Toxicity Criteria for Adverse Events of the National Cancer Institute (CTCAE) to v.4.03.|16 months|Analysis per protocol|||participants|||Number
2574461|NCT02481830|Secondary|Objective Response Rate (ORR)|The proportion of all randomized Participants who achieved BOR(Best Overall response) from baseline is either a CR(complete response) or PR(Partial response),using the RECIST v1.1 criteria based on investigator assessment,CR+PR, confidence interval based on the Clopper and Pearson method|Between the date of randomization and the date of progression or the date of subsequent anti-cancer therapy,whichever occurs first up to 34 months|All Randomized Participants|||Percentage of Participants||95% Confidence Interval|Number
2574462|NCT02481830|Secondary|Progression Free Survival (PFS )|"the time from randomization to the date of the first documented tumor progression (based on investigator assesment,using Response Evaluation Criteria in Solid Tumors (RECIST)1.1 criteria) or death the data was based on Kaplan-Meier Estimates.~PFS was censored when subsequent anti cancer therapy was started before progression."|assessed every 6 weeks from the first dose to week 30, and every 12 weeks up to 34 months.|All Randomized Participants|||Months||95% Confidence Interval|Median
2574463|NCT02481830|Primary|Overall Survival (OS)|The time from randomization to the date of death, data was based on Kaplan-Meier Estimates.|OS was followed continuously while participants were on the study drug and every 3 months ,minimum follow up for overall survival was 15.8 months|All Randomized Participants|||Months||95% Confidence Interval|Median
2574464|NCT02481596|Secondary|Diabetes Self-efficacy|as measured by scores on the Perceived Diabetes Self-Management Scale (4-item version) ranging from 4 = low self-efficacy (worse) to 20 = high self-efficacy (better)|3 months, 6 months||||score on a scale||Inter-Quartile Range|Median
2574773|NCT02476994|Secondary|Phytosterol, Cholesterol, and Squalene Levels||Up to 90 Days|Due to early termination of the study, no formal analysis was conducted.||||||
2574470|NCT02481557|Secondary|Change From Baseline for Yeaple Probe|"Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a yes response was repeated. If a second yes was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive yes responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure."|10 Minutes|Thirty-six (36) subjects received study products. Thirty-six (36) subjects completed the study.|||Units on a scale||Standard Deviation|Mean
2574471|NCT02481557|Primary|Change From Baseline Air Challenge|The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline. The mean change from Baseline was calculated for this measure.|10 Minutes|Thirty-Six (36) subjects received products. Thirty-Six (36) subjects completed the study.|||Units on a scale||Standard Deviation|Mean
2574472|NCT02481375|Primary|Hemoglobin Levels at 12-weeks. Marginal Means (95% CI).|Marginal means (95% CI) at 12-weeks using a generalized mixed-effects model with adjustments for baseline values and village clusters. Multiple imputation was used to impute n=49 missing values for hemoglobin at endline.|12-weeks of intervention||||g/L||95% Confidence Interval|Mean
2574473|NCT02481258|Secondary|Change in Left Ventricular Function|Determine whether long-term treatment with HMR1766 will result in sustained increases in systemic sGC signaling slow progression of aortic valve dysfunction in patients with mild to moderate CAVS. This will be done using echocardiography-based measurements of aortic valve function. Key comparisons will be between HMR1766-treated and placebo-treated groups, where we will examine the change in: 1. Left ventricular systolic function (measured by echocardiographic measurement of left ventricular ejection fraction) and 2. Left ventricular diastolic function (measured using the E/A ratio derived from Doppler measurements).|baseline, 6 mos|||||||
2574474|NCT02481258|Secondary|Change in Aortic Valve Function|"Determine whether long-term treatment with HMR1766 will result in sustained increases in systemic sGC signaling slow progression of aortic valve dysfunction in patients with mild to moderate CAVS. This will be done using echocardiography-based measurements of aortic valve function. Key comparisons will be between HMR1766-treated and placebo-treated groups, where we will examine the change in:~aortic valve area over time (calculated from the continuity equation) in subjects receiving HMR1766 or placebo capsules, AVA will be evaluated by both the absolute value and following normalization for body surface area, and~mean transvalvular pressure gradient over time (calculated from the blood velocity trace using the Bernoulli equation) in subjects receiving HMR1766 or placebo capsules."|baseline, 6 mos|||||||
2574475|NCT02481258|Secondary|Change in Levels of Plasma Interleukin-6 and Plasma Tumor Necrosis Factor Alpha|Determine whether long-term treatment with HMR1766 will result in sustained increases in systemic sGC signaling and reduce levels of circulating inflammatory cytokines in patients with mild to moderate CAVS. This will be done using ELISA-based measurements of interleukin-6 and tumor necrosis factor alpha in venous blood samples. Key comparisons will be between HMR1766-treated and placebo-treated groups, where we will examine the change in inflammatory cytokine levels from baseline in subjects receiving HMR1766 or placebo capsules.|baseline, 6 mos|||||||
2574476|NCT02481258|Primary|Changes in Aortic Valve Calcium Levels|"This will be done using computed tomography (CT) scanning to evaluate aortic valve calcium levels, which is considered to be a gold standard for evaluating valvular calcium burden. As measured in Arbitrary Units (AU)."|baseline, 6 mos||||Arbitrary Units||Standard Error|Mean
2574477|NCT02481219|Secondary|Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE|Will be assesses by applicable CRF|Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day.|Full analysis set|||percentage of participants with >1 AE|||Number
2574478|NCT02481219|Secondary|Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE|Will be assesses by applicable case report form (CRF)|an expected average of 3 weeks from study procedure|PPAS: Subjects withdrawn prior to the PillCam procedure (3) and subjects with one or more of the following protocol deviations (13) have been excluded: Evening PEG intake <1h and > 2.15h, Morning PEG intake <1h and >2:15 h, Capsule ingestion l<45 min or >75 min after PEG intake , Overall PEG intake volume is less than 3 liters|||percentage of participants|||Number
2574479|NCT02481219|Secondary|Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE|Will be assessed from RAPID video in total and by segment|an expected average of 3 weeks from study procedure|Per protocol analysis set|||percentage of participants|||Number
2574480|NCT02481219|Secondary|Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE|Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment|an expected average of 3 weeks from study procedure|The following patients were excluded from the analysis:2 withdrawn patients, 1 LTF (Lost to follow-up) patient, 2 pattients with failed prcedure, 16 patients with incomplete COLON exam.|||hours||Full Range|Median
2574481|NCT02481219|Secondary|Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE|Will be assessed from RAPID video in total and by segment|an expected average of 3 weeks from study procedure|This analysis is a subset of the PPAs excluding patients with one or more missing video data for Cecum, Ascending and transverse colon. Patients with at least one polyp detected on overall segments.|||percentage of participants|||Number
2574482|NCT02481219|Primary|Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)|The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum).|Within two weeks of study procedure|this was calculated on the per protocol analysis (PPAS) set excluding patients with one (or more) unseen segment in Cecum, Ascending and Transverse colon.|||percentage of particpants|||Number
2574483|NCT02481141|Secondary|Change From Baseline in Triglycerides (Component of Lipid Profile)|Change from baseline measured at week 6 and week 12 only|Baseline, Week 6, Week 12|Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.|||mg/dL||Standard Error|Mean
2574484|NCT02481141|Secondary|Change From Baseline in HDL (Component of Lipid Profile)|Change from baseline measured at week 6 and week 12 only|Baseline, Week 6, Week 12|Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.|||mg/dL||Standard Error|Mean
2574485|NCT02481141|Secondary|Change From Baseline LDL (Component of Lipid Profile)|Change from baseline measured at week 6 and week 12 only|Baseline, Week 6, Week 12|Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.|||mg/dL||Standard Error|Mean
2574486|NCT02481141|Secondary|Change From Baseline in Total Cholesterol (Component of Lipid Profile)|Change from baseline measured at week 6 and week 12 only|Baseline, Week 6, Week 12|Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.|||mg/dL||Standard Error|Mean
2574487|NCT02481141|Secondary|Change From Baseline in HbA1c|Change from baseline in HbA1c %|Baseline, Week 2, Week 4, Week 12|Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.|||percentage of HbA1c||Standard Error|Mean
2574488|NCT02481141|Secondary|Change From Baseline in Body Weight|Change from baseline measured at week 6 and week 12 only|Baseline, Week 6, Week 12|Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.|||kg||Standard Error|Mean
2574489|NCT02481141|Secondary|Change From Baseline in 2 Hour Post Meal Glucose Level|Change from baseline in blood glucose levels 2 hours after breakfast|Baseline, Week 2, Week 4, Week 12|Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.|||mg/dL||Standard Error|Mean
2574490|NCT02481141|Primary|Change From Baseline in Fasting Blood Glucose|The objective of the current study was to investigate the safety and preliminary efficacy of doses up to 200 mg 5-ALA - SFC in a population of patients with type 2 diabetes mellitus living in Bahrain.|Baseline, Week 2, Week 4, Week 12|Intent‐to‐Treat Population (ITT) included all subjects who took at least one dose of study product and had at least one post‐baseline efficacy evaluation. Change from Baseline was calculated as the mean for the visit compared to baseline mean for only the subjects with a result for that visit.|||mg/dL||Standard Error|Mean
2574491|NCT02481141|Primary|Subjects With Adverse Events as a Measure of Safety and Tolerability|The objective of the current study was to investigate the safety and preliminary efficacy of doses up to 200 mg 5-ALA - SFC in a population of patients with type 2 diabetes mellitus living in Bahrain.|Week 2, Week 4, Week 12|Safety population included all subjects who took at least one dose of study product.|||Participants|||Count of Participants
2574492|NCT02481050|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)|The FAS included all participants who received any amount of study drug.|||Participants|||Count of Participants
2574493|NCT02481050|Secondary|Feasibility Rate|Feasibility rate is defined as the percentage of participants completing the first 2 and 4 cycles (1 cycle = 28 days) of eribulin mesylate treatment (4 and 8 doses) without requiring dose delay greater than (>) 5 days or reduction due to adverse event (AE).|Cycle 2 Day 28 and Cycle 4 Day 28 ( cycle length=28 days)|The FAS included all participants who received any amount of study drug. The FAS where data at specified timepoints was available.|||percentage of participants||95% Confidence Interval|Number
2574494|NCT02481050|Secondary|Overall Survival (OS)|OS was defined as the time from date of first dose of study drug until date of death from any cause.|From date of first dose of study drug administration until date of death from any cause (approximately up to 2.3 years)|The FAS included all participants who received any amount of study drug.|||months||95% Confidence Interval|Median
2574495|NCT02481050|Secondary|Progression-Free Survival (PFS) by Investigator Assessment|PFS was defined as the time from date of first dose of study drug to the date of disease progression or death, whichever occurred first.|From first dose of study drug until intercurrent illness, unacceptable toxicity, disease progression, or until the participant withdrew consent (approximately up to 2.3 years)|The FAS included all participants who received any amount of study drug.|||months||95% Confidence Interval|Median
2574509|NCT02480764|Secondary|Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure (DBP)|The change in trough clinic sitting DBP measured at Week 8 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting DBP measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose.|Baseline and Week 8|FAS included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using LOCF. Number analyzed at a visit is the number of participants with data available for analysis at the given time-point.|||mm Hg||Standard Error|Least Squares Mean
2574774|NCT02476994|Secondary|Weight||Up to 90 Days|Due to early termination of the study, no formal analysis was conducted.||||||
2574775|NCT02476994|Secondary|Fatty Acid Profile||Up to 90 Days|Due to early termination of the study, no formal analysis was conducted.||||||
2574496|NCT02481050|Primary|Disease Control Rate (DCR) by Investigator Assessment|DCR was defined as the percentage of participants who had BOR of CR, PR, or stable disease (SD) measured by RECIST 1.1. CR defined as disappearance of all target lesions (a short diameter is <10 mm if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with Baseline summed LD. SD defined as reduction in tumor volume of less than 50% or an increase in the volume of 1 or more measurable lesions of less than 25% without the appearance of any new lesions which was neither tumor shrinkage corresponding to PR nor tumor expansion corresponding to disease progression. SD must be achieved at greater than equal to (>=) 7 weeks after the first eribulin administration to be considered BOR.|From first dose of study drug until intercurrent illness, unacceptable toxicity, disease progression, or until the participant withdrew consent (approximately up to 2.3 years)|The EAS included all participants who had both an evaluable baseline tumor assessment and an evaluable postbaseline tumor assessment, unless the participants discontinued because of disease progression or toxicity.|||percentage of participants||95% Confidence Interval|Number
2574497|NCT02481050|Primary|Objective Response Rate (ORR) by Investigator Assessment|ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) measured by response evaluation criteria in solid tumors (RECIST) 1.1. CR defined as disappearance of all target lesions (a short diameter is less than [<] 10 millimeter [mm] if it exists in a lymph node). PR defined as at least 30 percent (%) decrease in the sum of the long diameter (LD) of all target lesions, as compared with Baseline summed LD.|From first dose of study drug until intercurrent illness, unacceptable toxicity, disease progression, or until the participant withdrew consent (approximately up to 2.3 years)|The evaluable analysis set (EAS) included all participants who had both an evaluable baseline tumor assessment and an evaluable postbaseline tumor assessment, unless the participants discontinued because of disease progression or toxicity.|||percentage of participants||95% Confidence Interval|Number
2574498|NCT02480998|Secondary|Percentage of Subjects With a Pre-vaccination (Day 0) HI Antibody Titer < 1:40|Percentage of subjects with a pre-vaccination (Day 0) HI antibody titer < 1:40 who have achieved a minimum four-fold rise in HI antibody titer post-vaccination|28 days|||||||
2574499|NCT02480998|Secondary|GMR|Geometric Mean Ratio|28 days|||||||
2574500|NCT02480998|Secondary|GMT|Geometric Mean Titer|28 days|||||||
2574501|NCT02480998|Primary|Seroprotection Rate|Percentage of subjects achieving seroprotection* for HI antibody after vaccination|28 days||||percentage of participants||95% Confidence Interval|Number
2574502|NCT02480998|Primary|Seroconversion Rate|Percentage of subjects achieving seroconversion* for HI antibody after vaccination|28 days||||percentage of participants||95% Confidence Interval|Number
2574503|NCT02480920|Primary|Compliance of NOACs in Turkish Population|"Factors that may affect drug adherence and adverse events will be assessed by self-report questionnaires. Non-adherence will be tested for demographic, clinical, awareness of NOAC therapy and socioeconomic factors.~The validity of the Morisky Adherence Scale had already been demonstrated with regard to medication adherence in patients receiving vitamin K antagonists. An extended 8-item Morisky scale was used instead of the original 4-item Morisky scale in order to better identify the situations and the conditions that could affect medication adherence and to better assess the psychometric features.The reliability and the validity of the 8-item Morisky Adherence Scale translated into Turkish had been demonstrated in Turkish population by previous studies."|10 months||||Participants|||Count of Participants
2574504|NCT02480764|Secondary|Percentage of Participants Who Achieved Target Clinic SBP <130 mm Hg, Target Clinic DBP <80 mm Hg or Both at Week 8|Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose.|Week 8|FAS included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using LOCF.|||percentage of participants|||Number
2574505|NCT02480764|Secondary|Percentage of Participants Who Achieved Target Clinic SBP <140 mm Hg, Clinic DBP <90 mm Hg or Both at Week 8|Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose.|Week 8|FAS included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using LOCF.|||percentage of participants|||Number
2574506|NCT02480764|Secondary|Percentage of Participants Who Achieved Both Clinic SBP and DBP Response at Week 8|Clinic SBP response was defined as clinic SBP <140 mm Hg and/or reduction of ≥20 mm Hg from Baseline and clinic DBP response was defined as clinic DBP <90 mm Hg and/or reduction of ≥10 mm Hg from Baseline. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose.|Week 8|FAS included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using LOCF.|||percentage of participants|||Number
2574507|NCT02480764|Secondary|Percentage of Participants Who Achieved a Clinic DBP Response at Week 8|Clinic DBP response was defined as clinic DBP <90 mm Hg and/or reduction of ≥10 mm Hg from Baseline. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose.|Week 8|FAS included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using LOCF.|||percentage of participants|||Number
2574508|NCT02480764|Secondary|Percentage of Participants Who Achieved a Clinic SBP Response at Week 8|Clinic SBP response was defined as clinic SBP <140 mm Hg and/or reduction of ≥20 mm Hg from Baseline. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose.|Week 8|FAS included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using LOCF.|||percentage of participants|||Number
2574671|NCT02478372|Primary|Proportion of Patients Discharged From Rehabilitation by Day Four|"% of patients meeting predetermined discharge criteria at 96 Hours post-surgery.~The discharge criteria were: self dependent (dress, personal care); in and out of bedd independently; up and down stairs; walk with crutches/stick; 80 degrees knee flexion; able to straight leg raise operated limb."|96 hours|Patients included following randomisation|||percentage of patients|||Number
2574510|NCT02480764|Primary|Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure (SBP)|The change in trough clinic sitting SBP measured at Week 8 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting SBP measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 8 blood pressure was measured approximately 24 hours after the previous day's dose.|Baseline and Week 8|Full Analysis Set (FAS) included all randomly assigned participants who received at least 1 dose of double-blind study drug. Missing values were imputed using last observation carried forward (LOCF). Number analyzed at a visit is the number of participants with data available for analysis at the given time-point.|||mm Hg||Standard Error|Least Squares Mean
2574511|NCT02480712|Secondary|Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12||Week 12; Posttreatment Week 12|"Participants in the Safety Analysis Set with available data were analyzed by TDF-containing ART at baseline:~Boosted TDF-containing regimens~Non-boosted TDF-containing regimens~Non TDF-containing regimens"|||mg/dL||Standard Deviation|Mean
2574512|NCT02480712|Secondary|Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment||Up to 12 Weeks|"Participants in the Safety Analysis Set with available data were analyzed by TDF-containing ART at baseline:~Boosted TDF-containing regimens~Non-boosted TDF-containing regimens~Non TDF-containing regimens"|||percentage of participants|||Number
2574513|NCT02480712|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2574514|NCT02480712|Secondary|HCV RNA Change From Baseline/Day 1||Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2574515|NCT02480712|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Up to 12 Weeks|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2574516|NCT02480712|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2574517|NCT02480712|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
2574518|NCT02480712|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: All enrolled participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2574519|NCT02480621|Primary|Pain Levels on a Visual Analog Scale ( VAS)|A Visual Analog Scale (VAS) ranging from 0 to 10 in increments of 1 was used to both qualitatively and quantitatively assess the level and severity of pain during the time points ranging from the immediate post-operative period through 72 hours post-operative. Each number on the scale is accompanied by a visual facial expression that indicates the level of pain, discomfort, and distress appropriate to the number on the scale. The more severe the level of pain, the higher the corresponding number and more distressing the accompanying facial expression. A VAS score of 0 indicates no active pain level and is accompanied by a pleasantly smiling face whereas a VAS score of 10 indicates the most severe active pain level and is accompanied by a visibly-distraught face that is frowning, grimacing, and sweating. The combination of facial expressions and numbers is supposed to provide a language-independent, validated means of assessing pain levels.|Immediate post-operative period until 72 hours post-operatively||||units on a scale||Standard Deviation|Mean
2574520|NCT02480582|Secondary|24 Hour Energy Intake|Measured reductions in total within-day energy intake following consumption of almonds as a mid-morning snack compared to control and comparator. Food will be weighed pre- and post-consumption to the nearest 0.1g, at every test meal, to determine energy intake. Total energy intake will then be calculated. 24 hour energy intake will be measured on three occasions, on average a week apart.|3 Weeks||||kcal||Standard Deviation|Mean
2574521|NCT02480582|Secondary|Appetite Sensations (Hunger)|"Measured differences in hunger following consumption of almonds as a mid-morning snack compared to control and comparator.~Appetite sensations will be measured during the three intervention conditions at regular time intervals from the morning to the evening (21 in total) using 100-mm visual analogue scale (VAS).~Scale range = 0-100 mm, with higher values indicating greater hunger. Total Area Under the Curve will be calculated from the VAS profiles using the trapeziodal method.~Time points at which data were collected to calculate AUC - -5, 15, 30, 60, 90, 120, 135, 180, 230, 240, 270, 280, 300, 360, 420, 480, 510, 540, 600; -5 to 8 hours post intervention.~Higher AUC scores on hunger are interpreted as a worse outcome."|3 Weeks||||minutues*mm||Standard Deviation|Mean
2574522|NCT02480582|Secondary|Food Preference|"Measured changes in wanting for high fat food food following consumption of almonds as a mid-morning snack compared to control and comparator.~Food preference will be measured once during each intervention condition using the Leeds Food Preference Questionnaire (LFPQ: Finlayson, King & Blundell, 2008).~8 high fat foods and 8 low fat foods are presented on a computer and participants rate the extent to which they want each food (How much do you want this food now?). The food images are presented individually, in a randomised order and participants make their ratings using a 100-mm VAS. Low fat scores are subtracted from high fat scores to provide a relative preference score.~Scale range: -100 to 100. Higher scores indicate greater wanting for high fat foods which is interpreted as a worse outcome."|3 Weeks||||units on a scale||Standard Deviation|Mean
2574523|NCT02480582|Primary|Test Meal Energy Intake|Measured reductions in ad-libitum energy intake following consumption of almonds as a mid-morning snack compared to control and comparator. Food will be weighed pre- and post-consumption to the nearest 0.1g to determine energy intake. Test meal energy intake will be measured on three occasions, on average a week apart.|3 Weeks||||kcal||Standard Deviation|Mean
2574524|NCT02480439|Secondary|Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose|Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (beats per minute [bpm]).|First dose of study drug to 7 days after the last dose of study drug (Up to Day 24)|Safety Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2574525|NCT02480439|Secondary|Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose||First dose of study drug to 7 days after the last dose of study drug (Up to Day 24)|Safety Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2574526|NCT02480439|Secondary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug to 30 days after the last dose of study drug (Up to Day 47)|Safety Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2574527|NCT02480439|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648||Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period|The PK Set included all participants who received at least 1 dose of study drug and had at least 1 measurable postdose plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2574528|NCT02480439|Primary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648||Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period|The PK Set included all participants who received at least 1 dose of study drug and had at least 1 measurable postdose plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2574529|NCT02480439|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-648||Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period|The PK Set included all participants who received at least 1 dose of study drug and had at least 1 measurable postdose plasma concentration.|||mg/mL||Standard Deviation|Mean
2574530|NCT02480166|Secondary|Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment.|Adverse events were defined using Common Terminology Criteria for Adverse Events v3.0 (CTCAE)|Day 1 of treatment to 12 weeks post treatment||||Participants|||Count of Participants
2574531|NCT02480166|Primary|Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment||12 weeks after end of therapy||||Participants|||Count of Participants
2574532|NCT02480153|Other Pre-specified|Percentage of Participants Who Achieved Delivery Success in Sub-study|A sub-study was conducted to determine whether participants or their non-healthcare professional caregivers could safely and effectively administer PF-06410293 with the sponsor's prefilled pen (PFP) device.|Weeks 56, 58, 60, 62, 64, 66|The analysis population included all participants in the sub-study.|||percentage of participants|||Number
2574533|NCT02480153|Secondary|Number of Participants With Laboratory Abnormalities: Period 3|Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 3 (without regard to baseline abnormality) is presented.|Week 52 dosing up to follow-up visit (Week 92)|The analysis population included all participants enrolled and treated in Period 3 who had laboratory test in Period 3.|||Participants|||Count of Participants
2574534|NCT02480153|Secondary|Number of Participants With Laboratory Abnormalities: Period 2|Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 2 (without regard to baseline abnormality) is presented.|Week 26 dosing up to Week 52 (pre-dose)|The analysis population included all randomized participants who received at least 1 dose of study treatment in Period 1, and received at least 1 dost of study treatment in Period 2, and had laboratory test in Period 2, analyzed by actual treatment received.|||Participants|||Count of Participants
2574535|NCT02480153|Secondary|Number of Participants With Laboratory Abnormalities: Period 1|Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 1 (without regard to baseline abnormality) is presented.|Baseline (Day 1) up to Week 26 (pre-dose)|The analysis population included all randomized participants who received at least 1 dose of study treatment and had laboratory test in Period 1, analyzed by actual treatment received.|||Participants|||Count of Participants
2574536|NCT02480153|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs for Period 3 were events between first dose of study drug in Period 3 and up to Week 92 visit that were absent before treatment or that worsened relative to prior state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.|Week 52 dosing up to follow-up visit (Week 92)|Safety population (Period 3) was defined as all participants enrolled and treated in Period 3.|||Participants|||Count of Participants
2574547|NCT02480153|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response：Period 1|Participants were considered to be in ACR/EULAR remission when either of the following criteria was met: scores on the tender joint count, swollen joint count, hs-CRP (mg/dL) and PGA (0-10 cm scale) were all =<1; or the score on the simplified disease activity index (SDAI) was =<3.3. SDAI score was the sum of tender joint count (28), swollen joint count (28), PGA (0-10 cm scale), physician's global assessment of arthritis (PGAA, 0-10 cm scale) and hs-CRP (mg/dL).|Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)|The ITT population (Period 1) was defined as all participants who were randomized to study treatment.|||Participants|||Count of Participants
2574537|NCT02480153|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs for Period 2 were events between first dose of study drug in Period 2 and up to Week 52 pre-dose assessments that were absent before treatment or that worsened relative to prior state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.|Week 26 dosing up to Week 52 (pre-dose)|Safety population (Period 2) was defined as all randomized participants who received at least 1 dose of study treatment in Period 1, and received at least 1 dost of study treatment in Period 2, analyzed by actual treatment received.|||Participants|||Count of Participants
2574538|NCT02480153|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs for Period 1 were events between first dose of study drug in Period 1 and up to Week 26 pre-dose assessments that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.|Baseline (Day 1) up to Week 26 (pre-dose)|Safety population (Period 1) was defined as all randomized participants who received at least 1 dose of study treatment, analyzed by actual treatment received.|||Participants|||Count of Participants
2574539|NCT02480153|Secondary|Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 3|Serum samples were analyzed for the presence or absence of ADA using a semi-quantitative electrochemiluminescent (ECL) assay, and ADA positive was defined as ADA titer >=1.88. Serum samples tested positive for ADA were further analyzed for the presence or absence of NAb using a semi-quantitative cell-based assay, and NAb positive was defined as NAb titer >=0.70.|Week 52 dosing up to follow-up visit (Week 92)|The analysis population included all participants enrolled and treated in Period 3 who had at least 1 ADA measurement in Period 3.|||Participants|||Count of Participants
2574540|NCT02480153|Secondary|Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 2|Serum samples were analyzed for the presence or absence of ADA using a semi-quantitative electrochemiluminescent (ECL) assay, and ADA positive was defined as ADA titer >=1.88. Serum samples tested positive for ADA were further analyzed for the presence or absence of NAb using a semi-quantitative cell-based assay, and NAb positive was defined as NAb titer >=0.70.|Week 26 dosing up to Week 52 (pre-dose)|The analysis population included all randomized participants who received at least 1 dose of study treatment in Period 1, and received at least 1 dose of study treatment in Period 2, and had at least 1 ADA measurement in Period 2, analyzed by actual treatment received.|||Participants|||Count of Participants
2574541|NCT02480153|Secondary|Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 1|Serum samples were analyzed for the presence or absence of ADA using a semi-quantitative electrochemiluminescent (ECL) assay, and ADA positive was defined as ADA titer >=1.88. Serum samples tested positive for ADA were further analyzed for the presence or absence of NAb using a semi-quantitative cell-based assay, and NAb positive was defined as NAb titer >=0.70.|Baseline up to Week 26 (pre-dose)|The analysis population included all randomized participants who received at least 1 dose of study drug, and had at least 1 ADA measurement in Period 1, analyzed by actual treatment received.|||Participants|||Count of Participants
2574542|NCT02480153|Secondary|Serum Concentration Versus Time Summary: Period 3||Pre-dose on Days 365, 393, 463, 547 and 575|The analysis population included all participants who received study drug and provided at least 1 post-dose drug concentration measurement in Period 3.|||ng/mL||Standard Deviation|Mean
2574543|NCT02480153|Secondary|Serum Concentration Versus Time Summary: Period 2||Pre-dose on Days 183, 211, 253 and 365|The analysis population included all participants who received study drug and provided at least 1 post-dose drug concentration measurement in Period 2.|||ng/mL||Standard Deviation|Mean
2574544|NCT02480153|Secondary|Serum Concentration Versus Time Summary: Period 1||Pre-dose on Days 1, 15, 43, 85 and 183, and at any time during Day 8 visit|The analysis population included all participants who received study drug and provided at least 1 post-dose drug concentration measurement in Period 1.|||ng/mL||Standard Deviation|Mean
2574545|NCT02480153|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 3|Participants were considered to be in ACR/EULAR remission when either of the following criteria was met: scores on the tender joint count, swollen joint count, hs-CRP (mg/dL) and PGA (0-10 cm scale) were all =<1; or the score on the simplified disease activity index (SDAI) was =<3.3. SDAI score was the sum of tender joint count (28), swollen joint count (28), PGA (0-10 cm scale), physician's global assessment of arthritis (PGAA, 0-10 cm scale) and hs-CRP (mg/dL).|Weeks 52, 56, 66, 76 and 78|The ITT population (Period 3) was defined as all participants enrolled in Period 3.|||Participants|||Count of Participants
2574546|NCT02480153|Secondary|Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 2|Participants were considered to be in ACR/EULAR remission when either of the following criteria was met: scores on the tender joint count, swollen joint count, hs-CRP (mg/dL) and PGA (0-10 cm scale) were all =<1; or the score on the simplified disease activity index (SDAI) was =<3.3. SDAI score was the sum of tender joint count (28), swollen joint count (28), PGA (0-10 cm scale), physician's global assessment of arthritis (PGAA, 0-10 cm scale) and hs-CRP (mg/dL).|Weeks 26, 30, 36, 44 and 52 (pre-dose)|The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.|||Participants|||Count of Participants
2574672|NCT02478359|Other Pre-specified|Triglycerides Levels|Cholesterol levels were obtained from values closest to the 12 months post randomization|12 months|As-treated Walk On population|||mg/dL||Standard Deviation|Mean
2574548|NCT02480153|Secondary|Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 3|The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) <2.6 indicates remission.|Weeks 52, 56, 66, 76 and 78|The ITT population (Period 3) was defined as all participants enrolled in Period 3.|||Participants|||Count of Participants
2574549|NCT02480153|Secondary|Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 2|The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) <2.6 indicates remission.|Weeks 26, 30, 36, 44 and 52 (pre-dose)|The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.|||Participants|||Count of Participants
2574550|NCT02480153|Secondary|Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 1|The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) <2.6 indicates remission.|Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)|The ITT population (Period 1) was defined as all participants who were randomized to study treatment.|||Participants|||Count of Participants
2574551|NCT02480153|Secondary|Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3|EULAR response was based on DAS28 EULAR response criteria. Good response was achieved if DAS28 improvement from baseline >1.2 and DAS28 =<3.2. Moderate response was achieved if DAS28 improvement from baseline >0.6 to =<1.2 and DAS28 =<5.1; or DAS improvement from baseline >1.2 and DAS28 >3.2. No response was achieved if DAS improvement from baseline =<0.6 (no matter present DAS28 score); or DAS improvement from baseline >0.6 to =<1.2 and DAS28 >5.1.|Weeks 52, 56, 66, 76 and 78|The ITT population (Period 3) was defined as all participants enrolled in Period 3.|||Participants|||Count of Participants
2574552|NCT02480153|Secondary|Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2|EULAR response was based on DAS28 EULAR response criteria. Good response was achieved if DAS28 improvement from baseline >1.2 and DAS28 =<3.2. Moderate response was achieved if DAS28 improvement from baseline >0.6 to =<1.2 and DAS28 =<5.1; or DAS improvement from baseline >1.2 and DAS28 >3.2. No response was achieved if DAS improvement from baseline =<0.6 (no matter present DAS28 score); or DAS improvement from baseline >0.6 to =<1.2 and DAS28 >5.1.|Weeks 26, 30, 36, 44 and 52 (pre-dose)|The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.|||Participants|||Count of Participants
2574553|NCT02480153|Secondary|Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1|EULAR response was based on DAS28 EULAR response criteria. Good response was achieved if DAS28 improvement from baseline >1.2 and DAS28 =<3.2. Moderate response was achieved if DAS28 improvement from baseline >0.6 to =<1.2 and DAS28 =<5.1; or DAS improvement from baseline >1.2 and DAS28 >3.2. No response was achieved if DAS improvement from baseline =<0.6 (no matter present DAS28 score); or DAS improvement from baseline >0.6 to =<1.2 and DAS28 >5.1.|Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)|The ITT population (Period 1) was defined as all participants who were randomized to study treatment.|||Participants|||Count of Participants
2574554|NCT02480153|Secondary|Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 3|The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. Higher score indicate more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L).|Baseline, Weeks 52, 56, 66, 76 and 78|The ITT population (Period 3) was defined as all participants enrolled in Period 3.|||units on a scale||Standard Deviation|Mean
2574563|NCT02480153|Secondary|Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 3|"Participants answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The participant's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled Very Well and the 100 mm end labeled Very Poorly."|Baseline, Weeks 52, 56, 66, 76 and 78|The ITT population (Period 3) was defined as all participants enrolled in Period 3.|||units on a scale||Standard Deviation|Mean
2574673|NCT02478359|Other Pre-specified|Total Cholesterol Levels|Cholesterol levels were obtained from values closest to the 12 months post randomization|12 months|As-treated Walk On population|||md/dL||Standard Deviation|Mean
2574555|NCT02480153|Secondary|Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 2|The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. Higher score indicate more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L).|Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)|The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.|||units on a scale||Standard Deviation|Mean
2574556|NCT02480153|Secondary|Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 1|The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. Higher score indicate more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L).|Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)|The ITT population (Period 1) was defined as all participants who were randomized to study treatment.|||units on a scale||Standard Deviation|Mean
2574557|NCT02480153|Secondary|Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 3|Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.|Baseline, Weeks 52, 56, 66, 76 and 78|The ITT population (Period 3) was defined as all participants enrolled in Period 3.|||mg/L||Standard Deviation|Mean
2574558|NCT02480153|Secondary|Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 2|Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.|Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)|The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.|||mg/L||Standard Deviation|Mean
2574559|NCT02480153|Secondary|Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1|Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.|Baseline, Weeks1, 2, 4, 6, 8, 12, 18 and 26 (pre-dose)|The ITT population (Period 1) was defined as all participants who were randomized to study treatment.|||mg/L||Standard Deviation|Mean
2574560|NCT02480153|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 3|"HAQ-DI assesses the degree of difficulty a participant had experienced during the past week in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing no difficulty, 1 as some difficulty, 2 as much difficulty, and 3 as unable to do. Any activity that required assistance from another individual or required the use of an assistive device would adjust to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 representing no difficulty, 1 as some difficulty, 2 as much difficulty, and 3 as unable to do. Higher score indicate more difficulty in performing daily living activities."|Baseline, Weeks 52, 56, 66, 76 and 78|The ITT population (Period 3) was defined as all participants enrolled in Period 3.|||units on a scale||Standard Deviation|Mean
2574561|NCT02480153|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 2|"HAQ-DI assesses the degree of difficulty a participant had experienced during the past week in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing no difficulty, 1 as some difficulty, 2 as much difficulty, and 3 as unable to do. Any activity that required assistance from another individual or required the use of an assistive device would adjust to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 representing no difficulty, 1 as some difficulty, 2 as much difficulty, and 3 as unable to do. Higher score indicate more difficulty in performing daily living activities."|Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)|The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.|||units on a scale||Standard Deviation|Mean
2574562|NCT02480153|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 1|"HAQ-DI assesses the degree of difficulty a participant had experienced during the past week in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing no difficulty, 1 as some difficulty, 2 as much difficulty, and 3 as unable to do. Any activity that required assistance from another individual or required the use of an assistive device would adjust to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 representing no difficulty, 1 as some difficulty, 2 as much difficulty, and 3 as unable to do. Higher score indicate more difficulty in performing daily living activities."|Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)|The ITT population (Period 1) was defined as all participants who were randomized to study treatment.|||units on a scale||Standard Deviation|Mean
2574674|NCT02478359|Other Pre-specified|HDL Levels|Cholesterol levels were obtained from values closest to the 12 months post randomization|12 months|As-treated Walk On population|||mg/dL||Standard Deviation|Mean
2574776|NCT02476994|Secondary|Genetic Polymorphisms in Fatty Acid Desaturase Genes FADS1 and FADS2||Baseline|Due to early termination of the study, no formal analysis was conducted.||||||
2574564|NCT02480153|Secondary|Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 2|"Participants answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The participant's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled Very Well and the 100 mm end labeled Very Poorly."|Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)|The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.|||units on a scale||Standard Deviation|Mean
2574565|NCT02480153|Secondary|Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 1|"Participants answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The participant's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled Very Well and the 100 mm end labeled Very Poorly."|Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)|The ITT population (Period 1) was defined as all participants who were randomized to study treatment.|||units on a scale||Standard Deviation|Mean
2574566|NCT02480153|Secondary|Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 3|Participants assessed the severity of their arthritis pain using a 100 mm Visual Analog Scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Baseline, Weeks 52, 56, 66, 76 and 78|The ITT population (Period 3) was defined as all participants enrolled in Period 3.|||units on a scale||Standard Deviation|Mean
2574567|NCT02480153|Secondary|Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 2|Participants assessed the severity of their arthritis pain using a 100 mm Visual Analog Scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)|The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.|||units on a scale||Standard Deviation|Mean
2574568|NCT02480153|Secondary|Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 1|Participants assessed the severity of their arthritis pain using a 100 mm Visual Analog Scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)|The ITT population (Period 1) was defined as all participants who were randomized to study treatment.|||units on a scale||Standard Deviation|Mean
2574569|NCT02480153|Secondary|Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 3|"The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and independent of the participant's reported assessments of PGA (patient's global assessment of arthritis) and PAAP (patient's assessment of arthritis pain). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled None and the 100 mm end labeled Extreme."|Baseline, Weeks 52, 56, 66, 76 and 78|The ITT population (Period 3) was defined as all participants enrolled in Period 3.|||units on a scale||Standard Deviation|Mean
2574570|NCT02480153|Secondary|Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 2|"The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and independent of the participant's reported assessments of PGA (patient's global assessment of arthritis) and PAAP (patient's assessment of arthritis pain). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled None and the 100 mm end labeled Extreme."|Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)|The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.|||units on a scale||Standard Deviation|Mean
2574571|NCT02480153|Secondary|Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 1|"The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and independent of the participant's reported assessments of PGA (patient's global assessment of arthritis) and PAAP (patient's assessment of arthritis pain). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled None and the 100 mm end labeled Extreme."|Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)|The ITT population (Period 1) was defined as all participants who were randomized to study treatment.|||units on a scale||Standard Deviation|Mean
2574572|NCT02480153|Secondary|Change From Baseline in Swollen Joint Count: Period 3|Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.|Baseline, Weeks 52, 56, 66, 76 and 78|The ITT population (Period 3) was defined as all participants enrolled in Period 3.|||joints||Standard Deviation|Mean
2574573|NCT02480153|Secondary|Change From Baseline in Swollen Joint Count: Period 2|Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.|Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)|The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.|||joints||Standard Deviation|Mean
2574574|NCT02480153|Secondary|Change From Baseline in Swollen Joint Count: Period 1|Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.|Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)|The ITT population (Period 1) was defined as all participants who were randomized to study treatment.|||joints||Standard Deviation|Mean
2574575|NCT02480153|Secondary|Change From Baseline in Tender Joint Count: Period 3|Sixty-eight (68) joints were assessed by an independent blinded joint assessor to determine the number of joints that were considered tender. The 68 joints assessed were: upper body including temporomandibular, sternoclavicular, acromioclavicular; upper extremity including shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as 1 unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (PIP II, III, IV, V), and distal interphalangeals (DIP II, III, IV, V); lower extremity including hip, knee, ankle, tarsus (subtalar, transverse tarsal and tarsometatarsal considered as 1 unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe interphalangeal, proximal and distal interphalangeals combined (PIP and DIP II, III, IV, V).|Baseline, Weeks 52, 56, 66, 76 and 78|The ITT population (Period 3) was defined as all participants enrolled in Period 3.|||joints||Standard Deviation|Mean
2574576|NCT02480153|Secondary|Change From Baseline in Tender Joint Count: Period 2|Sixty-eight (68) joints were assessed by an independent blinded joint assessor to determine the number of joints that were considered tender. The 68 joints assessed were: upper body including temporomandibular, sternoclavicular, acromioclavicular; upper extremity including shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as 1 unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (PIP II, III, IV, V), and distal interphalangeals (DIP II, III, IV, V); lower extremity including hip, knee, ankle, tarsus (subtalar, transverse tarsal and tarsometatarsal considered as 1 unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe interphalangeal, proximal and distal interphalangeals combined (PIP and DIP II, III, IV, V).|Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)|The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.|||joints||Standard Deviation|Mean
2574577|NCT02480153|Secondary|Change From Baseline in Tender Joint Count: Period 1|Sixty-eight (68) joints were assessed by an independent blinded joint assessor to determine the number of joints that were considered tender. The 68 joints assessed were: upper body including temporomandibular, sternoclavicular, acromioclavicular; upper extremity including shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as 1 unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (PIP II, III, IV, V), and distal interphalangeals (DIP II, III, IV, V); lower extremity including hip, knee, ankle, tarsus (subtalar, transverse tarsal and tarsometatarsal considered as 1 unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe interphalangeal, proximal and distal interphalangeals combined (PIP and DIP II, III, IV, V).|Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)|The ITT population (Period 1) was defined as all participants who were randomized to study treatment.|||joints||Standard Deviation|Mean
2574578|NCT02480153|Secondary|Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 3|ACR70 is a categorical variable indicating a 70% or greater improvement in tender and swollen joint counts and 70% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).|Weeks 52, 56, 66, 76 and 78|The ITT population (Period 3) was defined as all participants enrolled in Period 3.|||Participants|||Count of Participants
2574579|NCT02480153|Secondary|Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 2|ACR70 is a categorical variable indicating a 70% or greater improvement in tender and swollen joint counts and 70% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).|Weeks 26, 30, 36, 44 and 52 (pre-dose)|The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.|||Participants|||Count of Participants
2574580|NCT02480153|Secondary|Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 1|ACR70 is a categorical variable indicating a 70% or greater improvement in tender and swollen joint counts and 70% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).|Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)|The ITT population (Period 1) was defined as all participants who were randomized to study treatment.|||Participants|||Count of Participants
2574581|NCT02480153|Secondary|Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 3|ACR50 is a categorical variable indicating a 50% or greater improvement in tender and swollen joint counts and 50% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).|Weeks 52, 56, 66, 76 and 78|The ITT population (Period 3) was defined as all participants enrolled in Period 3.|||Participants|||Count of Participants
2574582|NCT02480153|Secondary|Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 2|ACR50 is a categorical variable indicating a 50% or greater improvement in tender and swollen joint counts and 50% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).|Weeks 26, 30, 36, 44 and 52 (pre-dose)|The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.|||Participants|||Count of Participants
2574583|NCT02480153|Secondary|Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 1|ACR50 is a categorical variable indicating a 50% or greater improvement in tender and swollen joint counts and 50% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).|Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)|The ITT population (Period 1) was defined as all participants who were randomized to study treatment.|||Participants|||Count of Participants
2574584|NCT02480153|Secondary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 3|ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).|Weeks 52, 56, 66, 76 and 78|The ITT population (Period 3) was defined as all participants enrolled in Period 3.|||Participants|||Count of Participants
2574675|NCT02478359|Other Pre-specified|LDL Levels|Cholesterol levels were obtained from values closest to the 12 months post randomization|12 months|As-treated Walk On population|||mg/dL||Standard Deviation|Mean
2574777|NCT02476994|Secondary|Parenteral Nutrition-Associated Cholestasis (PNAC)||Up to 90 Days|Due to early termination of the study, no formal analysis was conducted.||||||
2574585|NCT02480153|Secondary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 2|ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).|Weeks 26, 30, 36, 44 and 52 (pre-dose)|The ITT population (Period 2) was defined as all participants who completed the Period 2 randomization call.|||Participants|||Count of Participants
2574586|NCT02480153|Secondary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Other Time Points Other Than Week 12: Period 1|ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).|Weeks 2, 4, 6, 8, 18 and 26 (pre-dose)|The ITT population (Period 1) was defined as all participants who were randomized to study treatment.|||Participants|||Count of Participants
2574587|NCT02480153|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12: Period 1|ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).|Week 12|The Intent-to-Treat (ITT) population (Period 1) was defined as all participants who were randomized to study treatment. Non-responder imputation was applied.|||percentage of participants|||Number
2574588|NCT02480010|Secondary|Mean Residence Time (MRT) of Pertuzumab|MRT is the average time that pertuzumab is present in the systemic circulation and is measured in days.|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.|||days||Geometric Coefficient of Variation|Geometric Mean
2574589|NCT02480010|Secondary|Volume of Distribution at Steady State of Pertuzumab|The volume of distribution at steady state (Vss), also known as apparent volume of distribution, is a pharmacological, theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma.|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.|||mL||Geometric Coefficient of Variation|Geometric Mean
2574590|NCT02480010|Secondary|Serum Clearance of Pertuzumab|Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It is measured as milliliters per day (mL/day).|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.|||mL/day||Geometric Coefficient of Variation|Geometric Mean
2574591|NCT02480010|Secondary|Terminal Elimination Half-Life (t1/2) of Pertuzumab|t1/2 is the time in days required for the concentration of the drug to reach half of its original value|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.|||days||Geometric Coefficient of Variation|Geometric Mean
2574592|NCT02480010|Secondary|Time to Maximum Plasma Concentration (Tmax) of Pertuzumab|Cmax refers to the maximum (or peak) plasma concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and prior to the administration of a second dose. tmax is the time at which the Cmax is observed.|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1 and on Days 8 and 15, Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population|||days||Geometric Coefficient of Variation|Geometric Mean
2574593|NCT02480010|Secondary|Maximum Plasma Concentration of Pertuzumab|Cmax is the maximum (or peak) plasma concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered and prior to the administration of a second dose. Cmax is measured as micrograms per mL (μg/mL).|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2574594|NCT02480010|Secondary|AUC to Last Measurable Concentration (AUC0-last) of Pertuzumab|The AUC0-last is calculated from time 0 (prior to administration of medication) to last measured data point. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population|||µg*day/mL||Geometric Coefficient of Variation|Geometric Mean
2574632|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 8|The efficacy of AZD7594 was assessed in terms of change from baseline in morning trough forced expiratory volume in 1 second (FEV1) on Day 8 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product [IMP] on Day 7)|On Day 1 (pre-dose) and on Day 8 (pre-dose) in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Liters||95% Confidence Interval|Least Squares Mean
2574595|NCT02480010|Secondary|Area Under the Concentration Curve Extrapolated to Infinity (AUC0-Inf) of Pertuzumab|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUC is measured as micrograms times days per milliliter (µg*day/mL)|Cycles 1 and 2 (Weeks 3 and 6): predose (immediately prior to infusion) and within 15 minutes following the end of the infusion on Day 1, Day 8, and Day 15. Cycle 3 (Week 9) and beyond: predose and within 15 minutes following end of infusion on Day 1|ITT Population; Only participants with non-missing data were included in the analysis.|||µg*day/mL||Geometric Coefficient of Variation|Geometric Mean
2574596|NCT02480010|Secondary|Change From Baseline in N-Telopeptide|In bone physiology, the N-terminal telopeptide (or more formally, amino-terminal collagen crosslinks, and known by the acronym NTX) is a telopeptide that can be used as a biomarker to measure the rate of bone turnover. NTX can be measured in the urine (uNTX) or serum (serum NTX).|Screening, Weeks 6, 12, 24, 36 and 48|Data were not analyzed to due to early termination of the study.||||||
2574597|NCT02480010|Secondary|Change From Baseline in Bone Alkaline Phosphatase|Bone alkaline phosphatase (BAP) is the bone-specific isoform of alkaline phosphatase. Serum Bone alkaline phosphatase is used to measure osteoporosis and is measured as units per liter (u/L).|Screening, Weeks 6, 12, 24, 36 and 48|Data were not analyzed to due to early termination of the study.||||||
2574598|NCT02480010|Secondary|Time to Treatment Failure|Time to Treatment Failure was time to the first documentation of progressive disease, day of death while on study (or 30 days after withdrawing from the trial) or day of early discontinuation due to toxicity (adverse events or abnormal laboratory value), refusal of treatment/refusing to cooperate/withdrawing consent, insufficient therapeutic response, or failure to return, whichever is earliest, after the start of treatment. Participants who did not experience any of the above events while on study were censored on the day of their last PSA or tumor measurement, whichever was later.|Every 3 weeks up to a maximum of 18 weeks|ITT Population|||days||Full Range|Median
2574599|NCT02480010|Secondary|Overall Survival|Overall survival was defined as the interval of time in weeks between start of treatment and day of death. Participants who did not die while being followed were censored at the last time that they were known to be alive.|Screening, Every 3 weeks up to a maximum of 18 months|Data were not analyzed due to early termination of the study.||||||
2574600|NCT02480010|Secondary|Time to Prostate Cancer Pain Progression|Time to disease progression was defined by time in weeks from start of therapy to the onset of the earliest of the following events: 1) Opioid therapy, 2) Radiation therapy, 3) Glucocorticoid therapy, 4) Radionuclide therapy or 5) Chemotherapy.|Every 3 weeks up to a maximum of 18 weeks|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.||||||
2574601|NCT02480010|Secondary|Percentage of Participants Without Progression|Disease progression was defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Non-progression included participants who had responded plus those who had not responded and not progressed within the first 3 cycles.|Screening, Weeks 3, 6, 9 and 12|ITT population|||percentage of participants|||Number
2574602|NCT02480010|Secondary|Duration of Response According to RECIST Criteria|For participants with measurable disease, duration of response was defined as first documentation of tumor response, either a PR or CR, to first documentation of PD or death. Participants who never progressed or died were censored at their last tumor measurement.|Baseline, Weeks 6, 12, 24, 36 and 48|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.||||||
2574603|NCT02480010|Secondary|Duration of Response According to PSA Levels|Duration of PSA Response was measured from first 50% decline in PSA compared to baseline until the time at which there was an increase of ≥50% from the PSA nadir, provided the absolute increase was at least 5 nanograms per milliliter (ng/ml). The increase must have been confirmed by a second consecutive measurement that was at least 50% above the nadir.|Baseline, Every 3 weeks for a maximum of 18 months|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.||||||
2574604|NCT02480010|Secondary|Time to Response|Time to response was the date of the first documentation of PSA response.|Screening, Every 3 weeks for a maximum of 18 months|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.||||||
2574605|NCT02480010|Secondary|Percentage of Participants With Objective Response (Complete Response [CR] or Partial Response [PR]) by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Overall objective response by RECIST criteria (CR or PR) was to be defined for participants who had measurable disease at baseline or developed new lesions post-baseline. The longest diameter only for all target lesions was measured and the following responses recorded: CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter as compared to the baseline sum longest diameter.|Screening, Weeks 6, 12, 24, 36 and 48|This analysis was only planned if either cohort went to full recruitment. Analysis of this outcome in a small number of participants would have high variability and also unlikely to be relevant if safety and tolerability criteria were not met.||||||
2574606|NCT02480010|Secondary|Time to Disease Progression|Time to disease progression was defined by time in weeks from start of therapy to the onset of the earliest of the following events. 1) PSA progression as defined by the PSAWG, 2) Evidence of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 3) One bone scan at least 6 months subsequent to baseline demonstrating 2 or more new skeletal lesions and 4) An event due to metastatic prostate cancer requiring intervention.|Screening, Every 3 weeks up to a maximum of 18 months|ITT population|||weeks||Full Range|Median
2574676|NCT02478359|Other Pre-specified|HbA1c Levels|HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization|12 months|As-treated Walk On population|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2574607|NCT02480010|Primary|Percentage of Participants With Confirmed, Objective Response, Non-Response or Progressive Disease by PSA Levels Within the First 24 Weeks of Treatment With Pertuzumab|Objective PSA response rate was determined according to Prostate Specific Antigen Working Group (PSAWG) guidelines. All participants achieving a drop in PSA of greater than or equal to (≥) 50 percent (%) from baseline (confirmed with a second value at least 4 weeks later) fulfilled the criteria of a PSA response. The confirmatory second value had to be at least 50% lower than baseline, but could be higher than the first drop in PSA. Confirmatory value could not be 50% higher compared to first drop in PSA. The date of response was the date the first 50% (or greater) decline was observed. Progressive disease (PD) was defined by a minimum of three consecutive serum PSA measurements obtained at least 7 days apart within the previous 3 months of start of trial, which documented progressively increasing values. Non-response was defined as neither PD nor Response.|Screening, Every 3 weeks up to Week 24|ITT population|||percentage of participants|||Number
2574608|NCT02479880|Primary|Percentage of Participants With Bone-Related Adverse Events and/or a ≥ 4% Reduction in Bone Mineral Density (BMD) From Baseline to Week 96||Baseline to Week 96|Participants in the Safety Analysis Set (participants who were randomized into the study and received at least one dose of tenofovir DF) with available data were analyzed.|||percentage of participants|||Number
2574609|NCT02479763|Primary|Percentage of Patients With Successful Epidural Blocks|Fifteen minutes after the LA injection, a blinded observer will apply ice to the T1-L4 dermatomes and assess the epidural block. The criterion standard for success will be the presence of an epidural block (defined as a block to ice in at least 2 dermatomes bilaterally). If the operators cannot thread the catheter after 2 attempts, epidural blocks will considered failures.|up to 15 minutes after the procedure||||percentage of patients|||Number
2574610|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmin of AZD7594|Comparison of steady-state minimum (pre-dose) concentration (Cmin) of AZD7594 in each treatment period|On Day 14 at pre-dose in each period|The subset of all randomized participants, 24-hour PK sampling was performed on Day 14, primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data. Cmin was not determined for AZD7594 58 μg|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2574611|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-24)/D of AZD7594|Comparison of AUC(0-24)/D (dose-normalized AUC(0-24)) of AZD7594|On Day 14 in each period|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||h*pmol/L/ μmol||Geometric Coefficient of Variation|Geometric Mean
2574612|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmax/D of AZD7594|Comparison of Cmax/D (dose-normalized Cmax) of AZD7594|On Day 1 in each period|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||pmol/L/μmol||Geometric Coefficient of Variation|Geometric Mean
2574613|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cavg,ss of AZD7594|Comparison of Cavg,ss (average plasma concentration during a dosing interval at steady state) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2574614|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Tmax,ss of AZD7594|Comparison of tmax,ss (time to reach maximum plasma concentration at steady state) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||Hour||Full Range|Median
2574615|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of Tmax of AZD7594|Comparison of tmax (time to reach maximum plasma concentration) of AZD7594 on Day 1 of each treatment period; up to 6 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)|On Day 1 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||Hour||Full Range|Median
2574633|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) on Day 15|The efficacy of AZD7594 was assessed in terms of change from baseline in fractional exhaled nitric oxide (FeNO) on Day 15|On Day 1 (pre-dose) and on Day 15 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Parts per billion (ppb)||95% Confidence Interval|Least Squares Mean
2574616|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-last) of AZD7594|Comparison of AUC(0-last) (Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (Day 1 and Day 14)) of AZD7594 (i.e. in participants with intensive pharmacokinetic assessments)|On Day 1 and Day 14 in each period (in participants with intensive pharmacokinetic assessments, on Day 1 at pre-dose and 15 and 30 minutes, and 1, 2 and 4 h post-dose, on Day 14 at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||h*pmol/L||Geometric Coefficient of Variation|Geometric Mean
2574617|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of AUC(0-24) of AZD7594|Comparison of AUC(0-24) (Area under the plasma concentration-time curve from time zero to 24 hours after administration) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||h*pmol/L||Geometric Coefficient of Variation|Geometric Mean
2574618|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 Following Multiple Dose Administration by Assessment of Cmax,ss of AZD7594|Comparison of Cmax,ss (observed maximum plasma concentration at steady state) of AZD7594 on Day 14 of each treatment period; up to 10 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|On Day 14 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, 4, 8, 12, 16 and 24 h post-dose)|PKS included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2574619|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of AUC(0-4) of AZD7594|Comparison of AUC(0-4) (Area under the plasma concentration-time curve from time zero to 4 hours after administration) of AZD7594 on Day 1 of each treatment period; up to 6 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose).|On Day 1 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)|The subset of all randomized participants; 24-hour PK sampling was performed on Day 14, the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||h*pmol/L||Geometric Coefficient of Variation|Geometric Mean
2574620|NCT02479412|Secondary|Rate and Extent of Absorption of Three Dose Levels of AZD7594 by Assessment of Cmax of AZD7594|Comparison of Cmax (maximum observed plasma concentration) of AZD7594 on Day 1 of each treatment period; up to 6 samples were collected in each period (i.e. in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)|On Day 1 in each period (in participants with intensive pharmacokinetic assessments, at pre-dose and 15 and 30 minutes, and 1, 2, and 4 h post-dose)|The PK analysis set (PKS) included the subset of all randomized participants for whom 24-hour PK sampling was performed on Day 14, for whom the primary PK parameters (Cmax , AUC(0-4), Cmax,ss, AUC(0-24)) were calculated in at least one treatment period, and who had no major protocol deviations considered to impact the analysis of the PK data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2574621|NCT02479412|Secondary|Number of Participants With Adverse Events|Assessment of safety and tolerability of three dose levels of AZD7594 in participants with mild to moderate asthma. IP referred to investigational product.|From Screening to Follow-up (these two examinations are up to 165 days apart)|The safety analysis set (SAF) included all randomized participants who received at least one dose of randomized study drug during the treatment periods of the study. This analysis set was classified by actual treatment received. If no participants received incorrect treatment then the SAF was identical to the FAS.|||Number of participants|||Number
2574622|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of Asthma Control Days|The efficacy of AZD7594 was assessed in terms of amount of asthma control days in each treatment period. An asthma control day was defined as a day with asthma symptom score = 0, a night with no awakenings due to asthma symptoms and a day with no use of rescue medication. A given calendar day was defined as an asthma control day if it fulfills the criteria for a symptom-free day and for a rescue medication-free day|At baseline and from Day 1 to Day 14 post-dose in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Asthma control days||95% Confidence Interval|Least Squares Mean
2574623|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of Daily Symptom Score|The efficacy of AZD7594 was assessed in terms of change in daily symptom score from baseline to average of treatment period post dose (Day 1-14) in each treatment period. Severity scores for asthma symptoms were recorded twice daily, once in the morning and once in the evening with the scoring system of 0-no asthma symptoms, 1-toleratable asthma symptoms, 2-discomfort asthma symptoms with normal activities (or with sleep) and 3-asthma symptoms with impaired normal activities (or to sleep).|At baseline and from Day 1 to Day 14 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Unit on a scale||95% Confidence Interval|Least Squares Mean
2574624|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of Night-time Awakenings|"The efficacy of AZD7594 was assessed in terms of change in nighttime awakenings in each treatment period. The patients were asked to answer 'Yes' or 'No' to the question of Did your asthma cause you to wake up last night?. If yes, the number and percentage of days that had a night-time awakening were determined for each of the study periods."|At baseline and from Day 2 to Day 15 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Number of nighttime awakenings||95% Confidence Interval|Least Squares Mean
2574625|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline to Day 8 in Asthma Control Questionnaire-5|The efficacy of AZD7594 was assessed in terms of change from baseline to Day 15 in Asthma Control Questionnaire-5 in each treatment period. Five questions were asked and each question was scored on a scale of 0 to 6, where a lower score represents a more severe impairment/symptom. The ACQ-5 score at a given visit was defined as the average of the scores given for each of the questions, calculated as ACQ-5 score = Sum of 5 scores/5.|At baseline and on Day 8 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Unit on a scale||95% Confidence Interval|Least Squares Mean
2574626|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline to Day 15 in Asthma Control Questionnaire-5|The efficacy of AZD7594 was assessed in terms of change from baseline to Day 15 in Asthma Control Questionnaire-5 in each treatment period. Five questions were asked and each question was scored on a scale of 0 to 6, where a higher score represents a more severe impairment/symptom. The ACQ-5 score at a given visit was defined as the average of the scores given for each of the questions, calculated as ACQ-5 score = Sum of 5 scores/5.|At baseline and on Day 15 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Unit on a scale||95% Confidence Interval|Least Squares Mean
2574627|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Average Daily Use of Rescue Salbutamol Over the Treatment Period|The efficacy of AZD7594 was assessed in terms of change from baseline in average daily use of salbutamol (each morning and evening) in each treatment period.|Every day from Day 1 to Day 15 (from evening of Day 1 to morning of Day 15)|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Number of inhalations per day||95% Confidence Interval|Least Squares Mean
2574628|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Evening Peak Expiratory Flow (ePEF) Before Administration Over the Treatment Period|The efficacy of AZD7594 was assessed in terms of change from baseline in evening peak expiratory flow (ePEF) in each treatment period. The first PEF measurement was on the evening of Visit 1. Every morning and every evening after Visit 1, patients were required to perform 3 maneuvers for PEF assessment. The highest value from among the 3 assessments was marked as ePEF together with the date and time of the measurement. The final PEF assessment was done on the morning of Visit 11 (Day 15 of Treatment Period 3).|Every evening from Day 1 to Day 14 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||L/min||95% Confidence Interval|Least Squares Mean
2574629|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Morning Peak Expiratory Flow (mPEF) Before Administration Over the Treatment Period|The efficacy of AZD7594 was assessed in terms of change from baseline in morning peak expiratory flow (mPEF) before administration of the investigational medicinal product (IMP) in each treatment period. The first PEF measurement was on the evening of Visit 1. Every morning and every evening after Visit 1, patients were required to perform 3 maneuvers for PEF assessment. The highest value from among the 3 assessments was marked as mPEF with the date and time of the measurement. The final PEF assessment was done on the morning of Visit 11 (Day 15 of Treatment Period 3).|Every morning at pre-dose from Day 1 to Day 15|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||L/min||95% Confidence Interval|Least Squares Mean
2574630|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Vital Capacity (FVC) on Day 8|The efficacy of AZD7594 was assessed in terms of change from baseline in morning trough forced vital capacity (FVC) on Day 8 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product [IMP] on Day 7)|On Day 1 (pre-dose) and on Day 8 (pre-dose) in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Liters||95% Confidence Interval|Least Squares Mean
2574631|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Trough Forced Vital Capacity (FVC) on Day 15|The efficacy of AZD7594 was assessed in terms of change from baseline in morning trough forced vital capacity (FVC) on Day 15 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product [IMP] on Day 14)|On Day 1 (pre-dose) and on Day 15 (pre-dose) in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Liters||95% Confidence Interval|Least Squares Mean
2574634|NCT02479412|Secondary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) on Day 8|The efficacy of AZD7594 was assessed in terms of change from baseline in fractional exhaled nitric oxide (FeNO) on Day 8|On Day 1 (pre-dose) and on Day 8 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the FAS, following the principle of ITT. Participants were included in the analysis according to the treatment to which they were randomized.|||Parts per billion (ppb)||95% Confidence Interval|Least Squares Mean
2574635|NCT02479412|Primary|Efficacy of AZD7594 by Assessment of the Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) on Day 15|Comparison of the efficacy of AZD7594 in terms of change from baseline in morning trough forced expiratory volume in 1 second (FEV1) on Day 15 (defined as the average of the values at 23:00 and 23:30 hours after last dose of investigational medicinal product [IMP] on Day 14) with placebo|On Day 1 (pre-dose) and on Day 15 in each period|All randomized participants who received at least one dose of randomized study drug, were included in the full analysis set (FAS), following the principle of intent to treat (ITT). Participants were included in the analysis according to the treatment to which they were randomized.|||Liters||95% Confidence Interval|Least Squares Mean
2574636|NCT02479139|Secondary|Percentage of Participants With Gravimetric Sweat Production (GSP) Change From Baseline ≥ 50%|"GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.~The change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in GSP by ≥ 50% is reported."|Baseline, Weeks 4, 8, 12 and 18|mITT population was defined as all randomized participants who received at least 1 dose of investigational product with both a baseline value and ≥ 1 value during the double-blind treatment period. Missing values were imputed using the LOCF approach.|||percentage of participants|||Number
2574637|NCT02479139|Secondary|Percentage of Participants With Hyperhidrosis Disease Severity Scale (HDSS) Score Change From Baseline ≥ 2 Points|"The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities.~The change from Baseline was calculated. The percentage of participants who had a change (reduction) from Baseline in HDSS score by ≥ 2 points is reported."|Baseline, Weeks 4, 8, 12 and 18|mITT population was defined as all randomized participants who received at least 1 dose of investigational product with both a baseline value and ≥ 1 value during the double-blind treatment period. Missing values were imputed using the LOCF approach.|||percentage of participants|||Number
2574638|NCT02479139|Primary|Percentage of Participants With Both a Change From Baseline in Hyperhidrosis Disease Severity Scale (HDSS) Score by ≥ 2 Points and a Change From Baseline in Gravimetric Sweat Production (GSP) by ≥ 50%|"The HDSS is a patient completed scale that measures how excessive sweating effects quality of life using a 4-point scale where: 1=My underarm sweating is not noticeable and never interferes with my daily activities to 4= My underarm sweating is intolerable and always interferes with my daily activities.~GSP was measured using a pre-weighed filter paper placed into the axilla area (armpit) to collect sweat over a 5-minute period. The paper was removed and weighed to determine the amount of sweat produced.~The HDSS and the GSP were assessed at Baseline and Week 12. The change from Baseline was calculated. The percentage of participants who had both a change (reduction) from Baseline in HDSS score by ≥ 2 points and a change (reduction) from Baseline in GSP by ≥ 50% is reported."|Baseline, Week 12|Modified Intent-to-Treat (mITT) population was defined as all randomized participants who received at least 1 dose of investigational product with both a baseline value and ≥ 1 value during the double-blind treatment period. Missing values were imputed using the last observation carried forward (LOCF) approach.|||percentage of participants|||Number
2574639|NCT02478671|Secondary|Hand Perfusion as Measured by Pulse Oxymetry Waveform|pulse oxymetry waveform will be used to measure arterial perfusion|Subjects will be followed up to one week post procedure||||percent saturated||Full Range|Mean
2574640|NCT02478671|Primary|MRI Based Radial Artery Measurement|Each subject's radial artery will be measured using MRI at varying levels of pressure within the TR Band.|Subjects will be followed up to one week post procedure||||millimeters||Full Range|Mean
2574641|NCT02478632|Secondary|Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase|Total hip and lumbar spine BMD was assessed by Baseline third agent (INSTI, NNRTI, PI) using T-scores and Z-scores at indicated time points. DEXA scans of hip and spine were performed. The last pre-switch value (Week 48) was considered as LS Baseline and change from LS Baseline was calculated as the post-dose value minus LS Baseline value. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values > -1.0 are considered normal, T-score values <= -1.0 to > -2.5 indicate osteopenia, T-score values <= -2.5 to <-3.5 indicate osteoporosis and T-score values <= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores.|LS Baseline (Week 48), Week 100 and Week 148|LS ITT-ED Population.Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Scores on a scale||Standard Deviation|Mean
2574642|NCT02478632|Secondary|Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase|Total hip and lumbar spine BMD (expressed as areal density in g/cm^2) assessed by third agent class (INSTI, NNRTI, PI) at indicated time points. The last pre-switch value (Week 48) was considered as LS Baseline and percent change from LS Baseline was calculated as post-dose value minus LS Baseline value divided by LS Baseline value multiplied by 100.|LS Baseline (Week 48), Week 100 and Week 148|LS ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2574657|NCT02478398|Secondary|Percentage of Participants Reporting Anaphylaxis and/or Systemic Allergic Reactions|For the purposes of this study, systemic allergic reactions are allergic reactions that occur away from the site of study drug application (allergic reactions other than local application site reactions). Anaphylaxis is a severe allergic reaction that typically involves more than one body system.|Up to 35 weeks|The safety population was all participants as treated. One participant was randomized to placebo but received short ragweed pollen allergen extract for one day and is included in the short ragweed pollen allergen extract arm.|||Percentage of Participants|||Number
2574677|NCT02478359|Other Pre-specified|Systolic Blood Pressure|Average of all routine clinic blood pressure reading taken between 6 and 12-months post randomization. BP obtained with temperatures of >100F and those obtained in urgent care were excluded.|6-12 months following randomization|As-treated Walk On population|||mmHg||Standard Deviation|Mean
2574643|NCT02478632|Secondary|Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase|T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of same sex. Caucasian reference values were used to calculate T- and Z-scores. T-score values > -1.0 is normal; <= -1.0 to > -2.5 indicate osteopenia; <= -2.5 to <-3.5 indicate osteoporosis; <= -3.5 indicate severe osteoporosis. Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex in this study. Change from Baseline is the post-dose value minus Baseline value. Data for Week 48 only represents final results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations through 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, actual values of Week 48 DEXA data may vary slightly between Weeks 48 and 148 analyses.|Baseline (Day 1), Week 48, Week 100 and Week 148|ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Scores on a scale||Standard Deviation|Mean
2574644|NCT02478632|Secondary|Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase|Total hip and lumbar spine BMD (expressed as areal density in g/cm^2) assessed by third agent class (INSTI, NNRTI, PI) at indicated time points. Percent change from Baseline was calculated as post-dose value minus Baseline value divided by Baseline value multiplied by 100. BMD parameters expressed as areal density (g/cm^2) at Weeks 48, 100 and 148 reflect data adjusted following the ongoing longitudinal and cross-calibration of the multiple DEXA scanner instruments in this study. Data and analyses presented through Week 48 only represent the final results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations though Week 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, the actual values of Week 48 DEXA data may vary slightly between the Week 48 and Week 148 analyses.|Baseline (Day 1), Week 48, Week 100 and Week 148|ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||Standard Deviation|Mean
2574645|NCT02478632|Secondary|Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent|Total hip and lumbar spine BMD was assessed by Baseline third agent class (INSTI, NNRTI, PI) using T-scores and Z-scores at Baseline and Week 48. DEXA scans of hip and spine were performed. Value at Day 1 was considered as Baseline. Change from Baseline was calculated as the value at Week 48 minus Baseline value. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values > -1.0 are considered normal, T-score values <= -1.0 to > -2.5 indicate osteopenia, T-score values <= -2.5 to <-3.5 indicate osteoporosis and T-score values <= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores.|Baseline (Day 1) and Week 48|ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Scores on a scale||95% Confidence Interval|Mean
2574646|NCT02478632|Secondary|Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent|Total hip and lumbar spine BMD (expressed as areal density in g/cm^2) assessed by third agent class (INSTI, NNRTI, PI) at indicated time points. Percent change from Baseline was calculated as value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. Value at Day 1 was considered as Baseline. An ANCOVA model adjusted for Baseline BMD values was used to compare the difference in percent change from Baseline to Week 48 in total hip BMD or in lumbar spine BMD between the DTG+RPV and CAR arms by third agent class: INSTI, NNRTI or PI.|Baseline (Day 1) and Week 48|ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Percent change||95% Confidence Interval|Mean
2574647|NCT02478632|Secondary|Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase|The last pre-switch value (Week 48) was considered as LS Baseline and change from LS Baseline was calculated as the post-dose visit value minus LS Baseline value. DEXA scans of the left 'total hip' (femoral neck, hip, inter-trochanter areas, trochanter) and 'lumbar spine' (lumbar vertebral column) were performed. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values > -1.0 are considered normal, T-score values <= -1.0 to > -2.5 indicate osteopenia, T-score values <= -2.5 to <-3.5 indicate osteoporosis and T-score values <= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores.|LS Baseline (Week 48), Week 100, Week 148|LS ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X in category titles).|||Scores on a scale||Standard Deviation|Mean
2574648|NCT02478632|Secondary|Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase|T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of same sex. Caucasian reference values were used to calculate T- and Z- scores. T-score values: > -1.0 is normal; <= -1.0 to > -2.5 indicate osteopenia; <= -2.5 to <-3.5 indicate osteoporosis; <= -3.5 indicate severe osteoporosis. Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex in this study. Change from Baseline is post-dose visit value minus Baseline value. Data for Week 48 only represent final results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations through Week 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, actual values of Week 48 DEXA data may vary slightly between Weeks 48 and 148 analyses.|Baseline (Day 1), Week 48, Week 100 and Week 148|ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.|||Scores on a scale||Standard Deviation|Mean
2574649|NCT02478632|Secondary|Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 Assessed by T-score and Z-score|Total hip and lumbar spine BMD was assessed by T-scores and Z-scores. Day 1 was considered as Baseline. Change from Baseline was calculated as the value at Week 48 minus Baseline. DEXA scans of the left 'total hip' (femoral neck, hip, inter-trochanter areas, trochanter) and 'lumbar spine' (lumbar vertebral column) were performed. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values > -1.0 are considered normal, T-score values <= -1.0 to > -2.5 indicate osteopenia, T-score values <= -2.5 to <-3.5 indicate osteoporosis and T-score values <= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores.|Baseline (Day 1) and Week 48|ITT-ED Population. Only those participants with data available at specified time point were analyzed.|||Scores on a scale||95% Confidence Interval|Mean
2574650|NCT02478632|Secondary|Percent Change From Late Switch (LS) Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD-CAR Late Switch Group Through Late Switch Phase|Percent change in BMD (expressed as areal density in g/cm^2) as specified by DEXA scans of the left 'total hip' which included the femoral neck, trochanter and inter-trochanter areas was assessed by areal density at indicated time points. Percent change in BMD as specified by DEXA scans of the 'lumbar spine' which included the first lumbar vertebra (L1) to the fourth lumbar vertebra (L4) was assessed by areal density at indicated time points. The last pre-switch value (Week 48) was considered as LS Baseline and percent change from LS Baseline was calculated as post-dose visit value minus LS Baseline value divided by LS Baseline value multiplied by 100. The analysis was based on Late-Switch Intent-to-Treat Exposed DEXA (LS-ITT-ED) Population which comprised of all participants in the LS-ITT-E Population, and who were registered for the DEXA study.|LS Baseline (Week 48), Week 100 and Week 148|LS ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.|||Percent change||95% Confidence Interval|Mean
2574651|NCT02478632|Secondary|Percent Change From Baseline in Total Hip and Lumbar Spine BMD-DTG+RPV Early Switch Group Through Early and Late Switch Phase|Percent change in BMD (expressed as areal density in g/cm^2) as specified by DEXA scans of left 'total hip' which included femoral neck, trochanter and inter-trochanter areas and 'lumbar spine' which included L1 to L4 was assessed by areal density. Percent change from Baseline is post-dose value minus Baseline value divided by Baseline value multiplied by 100. BMD parameters at Weeks 48, 100 and 148 reflect data adjusted following the ongoing longitudinal and cross-calibration of multiple DEXA scanner instruments in this study. Data presented through Week 48 only represent results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations though Week 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, actual values of Week 48 DEXA data may vary slightly between Weeks 48 and 148 analyses.|Baseline (Day 1), Week 48, Week 100 and Week 148|ITT-ED Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.|||Percent change||95% Confidence Interval|Mean
2574652|NCT02478632|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Week 48|Percent change in BMD (expressed as areal density in g/cm^2) as specified by DEXA scans of the 'lumbar spine' which included the first lumbar vertebra (L1) to the fourth lumbar vertebra (L4) was assessed by areal density at Baseline and Week 48. The difference is adjusted percent change from Baseline to Week 48 between treatment groups. The estimated value in the statistical analysis is this difference and the upper and lower limit values shown are the 95% confidence intervals. Baseline was considered as Day 1 value and percent change from Baseline was calculated as Value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. An ANCOVA model was used to compare the difference in percentage change from Baseline at week 48 in lumbar spine BMD between the DTG+RPV and CAR arms.|Baseline (Day 1) and Week 48|ITT-ED Population. Only those participants with data available at specified time point were analyzed.|||Percent change||95% Confidence Interval|Mean
2574653|NCT02478632|Primary|Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 48|Percent change in BMD (expressed as areal density in grams per centimeter square [g/cm^2]) as specified by dual energy X-ray absorptiometry (DEXA) scans of the left 'total hip' which included the femoral neck, trochanter and inter-trochanter areas was assessed by areal density at Baseline and Week 48. The estimated value in the statistical analysis is this difference and the upper and lower limit values shown are the 95% confidence intervals. Baseline was considered as Day 1 and percent change from Baseline was calculated as Value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. An analysis of covariance (ANCOVA) model was used to compare the difference. The analysis was performed on Intent-to-Treat exposed DEXA (ITT-ED) Population which comprised of all participants in the ITT-E Population who received at least one dose of study treatment, and who were registered for the 202094 study.|Baseline (Day 1) and Week 48|ITT-ED Population. Only those participants with data available at specified time point were analyzed.|||Percent change||95% Confidence Interval|Mean
2574654|NCT02478580|Secondary|The Aldrete Score|Aldrete score used for readiness of PACU discharge by assigning numeric values to the criteria including activity, respiration, circulation, consciousness, and color. Each criterion is rated from 0 to 2, with a maximum score of 10. Scores in the range of 9 to 10 are considered satisfactory for PACU discharge.|2 hours after extubation||||units on a scale||Standard Error|Mean
2574655|NCT02478580|Primary|Postoperative Care Unit (PACU) Recovery Time|Participants will be followed for the duration of PACU stay, an expected average of 3 hours.|Immediate postoperative period (up to 3 hours)|Patient with obstructive sleep apnea undergoing surgery|||Minutes||Standard Deviation|Mean
2574656|NCT02478398|Secondary|Percentage of Participants Treated With Epinephrine|Self-injectable epinephrine was provided to each participant/parent/guardian at randomization in countries where it is a regulatory requirement, and was to be available around the time treatment is administered at home. Self-injectable epinephrine was intended for immediate self-administration for an anaphylactic reaction, including symptoms/signs of upper airway obstruction. Instances of treatment with forms of epinephrine other than systemic epinephrine (e.g., inhaled racepinephrine) were counted as use of epinephrine.|Up to 35 weeks|The safety population was all participants as treated. One participant was randomized to placebo but received short ragweed pollen allergen extract for one day and is included in the short ragweed pollen allergen extract arm.|||Percentage of Participants|||Number
2574658|NCT02478398|Secondary|Percentage of Participants Reporting Pre-specified Local Application Site Reactions|Pre-specified local application site reactions, irrespective of causality, included AEs related to lip swelling/edema, mouth swelling/edema, palatal swelling/edema, swollen tongue/edema, oropharyngeal swelling/edema, pharyngeal edema/throat tightness, oral pruritus, throat irritation, tongue pruritus, and ear pruritus.|Up to 35 weeks|The safety population was all participants as treated. One participant was randomized to placebo but received short ragweed pollen allergen extract for one day and is included in the short ragweed pollen allergen extract arm.|||Percentage of Participants|||Number
2574659|NCT02478398|Secondary|Average Rhinoconjunctivitis (RC) DMS During the Peak RS|This DMS endpoint consists of a total of scores for use of RC medications: loratadine syrup or tablets (6 points), olopatadine (6 points), and mometasone (8 points). The score range of the RC DMS is 0-20 points, and a lower DMS means that less medication is used. The method used for analysis of the RC DMS is a zero-inflated log-normal model, which takes the average RC DMS during the peak RS as the response and adjusts for the same terms as in the ANOVA model. The components that contribute to the DMS endpoint are collected in an e-diary completed by the participant/parent/guardian.|The 15-day period during the ragweed season with the highest moving pollen average|The analysis population includes all treated participants w/ ≥1 e-diary entry for the specified measurement and timeframe.|||Score on a scale||95% Confidence Interval|Mean
2574660|NCT02478398|Secondary|Average Rhinoconjunctivitis (RC) DSS During the Peak RS|The DSS consists of a total of 6 rhinoconjunctivitis symptoms: 4 rhinitis symptoms (runny nose, stuffy nose, sneezing, itchy nose) and 2 conjunctivitis symptoms (itchy eyes, watery eyes). The components that contribute to the DSS endpoint are collected in an e-diary completed by the participant/parent/guardian. The RC DSS is measured on a 4-point scale from 0 to 3 as follows: 0 (no sign/symptom evident) to 3 (sign/symptom that is hard to tolerate; may cause interference with activities of daily living and/or sleeping). The maximum DSS is 18 points if a participant experiences all 6 symptoms with an intensity of 3 for each symptom. The minimum DSS is 0 points if a participant experiences no symptoms. A lower DSS means symptoms are less severe. The evaluation is based on the average DSS during the peak RS.|The 15-day period during the ragweed season with the highest moving pollen average|The analysis population includes all treated participants w/ ≥1 e-diary entry for the specified measurement and timeframe.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2574661|NCT02478398|Secondary|Average TCS During the Entire RS|TCS is DSS plus DMS, assessed here during the entire RS. This starts from the first day of 3 consecutive days with ragweed pollen counts ≥10 grains/m^3 through the last day of the last occurrence of 3 consecutive days with ragweed pollen counts ≥10 grains/m^3. The duration of the entire RS is up to 13 weeks; this duration varies by site/region. The RC DSS assesses 6 allergy symptoms measured on a scale of 0 to 3 (score range: 0-18). A lower DSS indicates less RC symptoms. The RC DMS is based on use of RC rescue medications (loratadine, olopatadine, mometasone) with different scores/dose unit (score range: 0-20). A lower DMS indicates less RC medication use. The sum of RC DSS+DMS ranges from 0 to 38, with a lower score indicating less RC symptoms and medication use. Components contributing to the TCS for the entire RS are collected in an e-diary completed by the participant/parent/guardian.|Up to 13 weeks|The analysis population includes all treated participants w/ ≥1 e-diary entry for the specified measurement and timeframe.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2574662|NCT02478398|Primary|Total Combined Score (TCS) During the Peak Ragweed Season (RS)|TCS is daily symptom score (DSS) plus daily medication score (DMS), assessed in the peak RS (15 consecutive RS days with the highest 15-day average pollen count). The rhinoconjunctivitis (RC) DSS assesses 6 allergy symptoms measured on a scale of 0 to 3 (0=no symptoms, 3=severe symptoms; score range: 0-18). Lower DSS indicates less RC symptoms. The RC DMS is based on use of RC rescue medications (loratadine, olopatadine, mometasone), with different rescue medications being assigned different scores/dose unit (score range: 0-20). Lower DMS indicates less RC medication use. Summed RC DSS+DMS could range from 0 to 38; a lower score indicates less RC symptoms and medication use. Components that contribute to DSS and DMS endpoints are collected in an electronic diary (e-diary) completed by the participant/parent/guardian. Evaluation is based on average TCS during peak RS.|The 15-day period during the ragweed season with the highest moving pollen average|The analysis population includes all treated participants w/ ≥1 e-diary entry for the specified measurement and timeframe.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2574663|NCT02478372|Secondary|Total Number of Reported Participants With Complications and/or Adverse Events|The composite number of adverse events reported per group at 30 days and then one year post surgery|30 days and one year post-surgery||||participants|||Number
2574664|NCT02478372|Secondary|Patient Reported Outcome Measure - Oxford Knee Score|Units measured on old Oxford Score (12-60) from a 12 point questionnaire. Where in 60 is poor and lower scores are better patient reported outcome scores|one week prior to surgery, 6 weeks post-surgery , one year post-surgery||||units on a scale||Full Range|Median
2574665|NCT02478372|Secondary|Maximal Flexion Angle of the Operative Knee at Discharge From Rehabilitation||On day of discharge from rehabilitation in-patient care (average 96 hours post surgery)||||angle of flexion (degree)||Inter-Quartile Range|Median
2574666|NCT02478372|Secondary|Day of Ambulation|Proportion of patients per day to ambulate for the first time with the physiotherapist > 3 Metres|theatre day, day 1 post-surgery, day two post-surgery||||percentage of patients|||Number
2574667|NCT02478372|Secondary|Post-operative Nausea and Vomiting Scores|percentage of patients reporting either symptoms of nausea or vomiting over the first 72 hours following surgery. Scale 0-2 wherein 0=no nausea and vomiting, 1=nausea and 2= nausea and vomiting|24hours, 48 hours and 72 hours post-surgery||||percentage of patients reporting PONV|||Number
2574668|NCT02478372|Secondary|Post-operative Urinary Catheterisation Rates|% of patients requiring catheterisation for urinary retention post-surgery|72 hours post-surgery||||percentage of patients catheterised|||Number
2574669|NCT02478372|Secondary|Verbal Rating Score (VRS) Pain Scores|Summary 24 hour Verbal rated numerical pain scores were gathered each day. Scale range 0-10 where 0 is no pain and 10 is worst imaginable pain|24hours, 48 hours and 72 hours post-surgery||||units on a scale||Standard Deviation|Mean
2574670|NCT02478372|Secondary|Average Post-operative Length of Stay|Participants will be followed for the duration of hospital stay, an expected average of 5 days|Average number of days spent in hospital follwoing surgery, an expected average of 5 days||||days||Inter-Quartile Range|Median
2574679|NCT02478359|Other Pre-specified|Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays|As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.|2 to 12 months randomization|As-treated population|||Participants|||Count of Participants
2574680|NCT02478359|Other Pre-specified|Number of Participants With All-cause Observation Stays|As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.|2 to 12 months following randomization|As-treated population|||Participants|||Count of Participants
2574681|NCT02478359|Other Pre-specified|Number of Participants With All-cause Emergency Department Visits|As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.|2 to 12 months following randomization|As-treated population|||Participants|||Count of Participants
2574682|NCT02478359|Other Pre-specified|Number of Participants With All-cause Hospitalizations|As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.|2 to 12 months following randomization|As-treated population|||Participants|||Count of Participants
2574683|NCT02478359|Other Pre-specified|Number of Deaths Among Participants|As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.|2 to 12 months following randomization|As-treated population|||Participants|||Count of Participants
2574684|NCT02478359|Other Pre-specified|Number of Participants With All-cause Hospitalization, Emergency Department (ED) Visits, Observation Stays and Deaths|As-treated analyses using logistic regression models that included stabilized propensity score inverse probability of treatment weighting (IPTW) to balance baseline characteristics (socio-demographics, health behaviors, disease severity, comorbidities, inhalers/medications, and health care utilization in the prior year) between patients who participated in Walk On! intervention and the SC group. The first 2 months after randomization were excluded because it was expected that it would take approximately 2 months form the date of randomization to start the intervention.|2 to 12 months following randomization|As-treated population|||Participants|||Count of Participants
2574685|NCT02478359|Secondary|Body Mass Index|Body mass index measurements were based on values closest to the 12 months post randomization|12 months following randomization|ITT population|||kg/m^2||Standard Deviation|Mean
2574686|NCT02478359|Secondary|Triglycerides Levels|Cholesterol levels were obtained from values closest to the 12 months post randomization|12 months post randomization|ITT population|||mg/dL||Standard Deviation|Mean
2574687|NCT02478359|Secondary|Total Cholesterol Levels|Cholesterol levels were obtained from values closest to the 12 months post randomization|12 months following randomization|ITT population|||mg/dL||Standard Deviation|Mean
2574688|NCT02478359|Secondary|HDL Levels|Cholesterol levels were obtained from values closest to the 12 months post randomization|12 months following randomization|ITT population|||mg/dL||Standard Deviation|Mean
2574689|NCT02478359|Secondary|LDL Levels|Cholesterol levels were obtained from values closest to the 12 months post randomization|12 months following randomization|ITT population|||mg/dL||Standard Deviation|Mean
2574690|NCT02478359|Secondary|HbA1c Levels|HbA1c levels were obtained only from diabetics and on values closest to the 12 months post randomization|12 months following randomization|ITT population|||percentage of glycosylated hemoglobin,||Standard Deviation|Mean
2574691|NCT02478359|Secondary|Systolic Blood Pressure|Average of all routine clinic blood pressure reading taken between 6 and 12-months post randomization. BP obtained with temperatures of >100F and those obtained in urgent care were excluded.|12 months following randomization|ITT population|||mmHg||Standard Deviation|Mean
2574692|NCT02478359|Secondary|Diastolic Blood Pressure|Average of all routine clinic blood pressure reading taken between 6 and 12-months post randomization. BP obtained with temperatures of >100F and those obtained in urgent care were excluded.|12 months following randomization|ITT population|||mmHg||Standard Deviation|Mean
2574693|NCT02478359|Secondary|PROMIS-10 HRQL , Mental Health - 12 Months|The reported mean change between the baseline and 12 Months T-scores. Score range is 21-68. A positive change score reflects better mental health.|12 months|As treated population who completed the survey|||score on a scale||Standard Deviation|Mean
2574694|NCT02478359|Secondary|PROMIS-10 HRQL , Physical Health - 12 Months|The reported mean change between the baseline and 12 Months T-scores. Score range is 16-68. A positive change score reflects better physical functioning.|12 months|As treated population who completed the survey|||score on a scale||Standard Deviation|Mean
2574698|NCT02478359|Secondary|COPD Assessment Test, CAT - 12 Months|The reported mean change between the baseline and 12 Months scores for the Chronic Obstructive Pulmonary Disease Assessment Test (CAT). Score range is 0-40. A negative change score indicates fewer symptoms.|12 months|As treated population who completed the survey|||score on a scale||Standard Deviation|Mean
2574699|NCT02478359|Secondary|Number of Participants With COPD Exacerbation|COPD exacerbations were ascertained via pharmacy records and utilization data. An outpatient COPD exacerbation will be defined as a care touch (clinic visit, phone, or secure message encounter) with a diagnosis of COPD accompanied by a prescription of either an oral steroid or an antibiotic within 2 days|12 months following randomization|ITT population|||Participants|||Count of Participants
2574700|NCT02478359|Secondary|Number of Participants With COPD-Related Hospitalizations, ED Visits, and Observation Stays|Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site|12 months following randomization|ITT Population|||Participants|||Count of Participants
2574701|NCT02478359|Secondary|Number of Participants With All-cause Observation Stays|Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site|12 months following randomization|ITT population|||Participants|||Count of Participants
2574702|NCT02478359|Secondary|Number of Participants With All-cause Emergency Department Visits|Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site|12 months following randomization|ITT population|||Participants|||Count of Participants
2574703|NCT02478359|Secondary|Number of Participants With All-cause Hospitalizations|Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site|12 months following randomization|ITT population|||Participants|||Count of Participants
2574704|NCT02478359|Secondary|Number of Deaths Among Participants|Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site|12 months following randomization|ITT population|||Participants|||Count of Participants
2574705|NCT02478359|Primary|Number of Participants With All-cause Hospitalizations, Emergency Department (ED) Visits, Observation Stays, and Deaths|Covariates included in the adjusted multivariate models were age, FEV1% predicted, Charlson comorbidity index, oxygen use, hospitalization for COPD in previous 12 months, outpatient treated COPD exacerbation in previous 12 months, length of time since acute care utilization to randomization, use of LABA or ICS, PA level and study site|12 months following randomization|ITT population|||Participants|||Count of Participants
2574706|NCT02478164|Secondary|Progression-Free Survival (PFS)|PFS based on Kaplan-Meier is defined as the time from study entry to the earliest documentation of disease progression or death. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria.|3 months||||days||95% Confidence Interval|Median
2574707|NCT02478164|Secondary|Overall Survival (OS)|OS based on Kaplan-Meier is defined as the time from study entry to death or date last known alive.|2 years||||days||95% Confidence Interval|Median
2574708|NCT02478164|Secondary|Best Radiographic Response|Radiographic response was established based on Response Assessment in Neuro-Oncology (RANO) criteria with 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown status.|Disease was assessed radiographically for response every 8 weeks, assessed up to 24 weeks.||||Participants|||Count of Participants
2574709|NCT02478164|Primary|3-Month Progression-Free Survival (PFS3)|PFS3 is the proportion of patients remaining alive and progression-free at 3-months from study entry. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria. RANO criteria has 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown. CR: disappearance of all enhancing lesions, stable or improved non-enhancing lesions, and stable or improved clinically. PR: >= 50% decrease in sum of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, stable or improved non-enhancing lesions, and stable or improved clinically. PD: >25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition. SD: does not qualify for CR,PR or PD.|3 months||||Participants|||Count of Participants
2574710|NCT02477709|Primary|Effect of Gefapixant on BP|BP data will be summarized using descriptive statistics|6 hours||||units on a scale||Full Range|Mean
2574711|NCT02477618|Secondary|Number of Participants With a New Diagnosis of Epilepsy After Visit 11|"Here, study visits followed by R indicate the Open-label Treatment Period."|Up to 21 days|The Intent-to-Treat Analysis Set included all participants who had an infusion of blinded study drug initiated. Here, number of participants analyzed (N) indicates participants with available data at each time point for this outcome measure.|||Participants|||Count of Participants
2574712|NCT02477618|Secondary|Number of Separate Episodes of Status Epilepticus Up to Visit 12|"Here, study visits followed by R indicate the Open-label Treatment Period."|Up to 21 days|The Intent-to-Treat Analysis Set included all participants who had an infusion of blinded study drug initiated. Here, number of participants analyzed (N) indicates participants with available data at each time point for this outcome measure.|||episodes||Standard Deviation|Mean
2574778|NCT02476994|Primary|Essential Fatty Acid Deficiency (EFAD)|Holman Index Calculation|Up to 90 Days|Due to early termination of the study, no formal analysis was conducted.||||||
2574713|NCT02477618|Secondary|Number of Days After the End of the First Study Drug Infusion Without Seizures (Convulsive and Non-convulsive), up to Visit 12|"Here, study visits followed by R indicate the Open-label Treatment Period."|Up to 21 days|The Intent-to-Treat Analysis Set included all participants who had an infusion of blinded study drug initiated. Here, number of participants analyzed (N) indicates participants with available data at each time point for this outcome measure.|||days||Standard Deviation|Mean
2574714|NCT02477618|Secondary|Number of Days After the End of the First Study Drug Infusion Without Status Epilepticus, Up to Visit 12|"Here, study visits followed by R indicate the Open-label Treatment Period."|Up to 21 days|The Intent-to-Treat Analysis Set included all participants who had an infusion of blinded study drug initiated. Here, number of participants analyzed (N) indicates participants with available data at each time point for this outcome measure.|||days||Standard Deviation|Mean
2574715|NCT02477618|Secondary|Change in Clinical Global Impression Scale (CGI)|"The CGI scale was used to integrate several sources of information into a single rating of a participant's condition. The CGI was rated on a 7-point scale, from a minimum of 0 to a maximum of 7, where 0 = Not assessed; 1 = Normal, not at all ill; 2 = Borderline physically ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill participants. A negative change from baseline indicates improvement. A positive change from baseline indicates worsening. Here, study visits followed by R indicate the Open-label Treatment Period."|Up to 21 days|The Intent-to-Treat Analysis Set included all participants who had an infusion of blinded study drug initiated. Here, number of participants analyzed (N) indicates participants with available data at each time point for this outcome measure.|||units on scale||Standard Deviation|Mean
2574716|NCT02477618|Secondary|Time Between the Secondary Outcome Measure Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression|Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression EEG pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG.|Up to 21 days|The Intent-to-Treat Analysis Set included all participants who had an infusion of blinded study drug initiated. Here, overall number of participants analyzed (N) indicates participants analyzed for this outcome measure.|||days||Full Range|Median
2574717|NCT02477618|Secondary|Number of Participants Able to be Weaned Off All Third-line Agents Before the End of the First SAGE-547 or Placebo Infusion|Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression EEG pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG.|Day 6|The Intent-to-Treat Analysis Set included all participants who had an infusion of blinded study drug initiated.|||Participants|||Count of Participants
2574718|NCT02477618|Secondary|Time Between the Primary Outcome Response and the Re-institution of Any Third-line Agent for Seizure or Burst Suppression|Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression EEG pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG. A responder was a participant who was able to be weaned off all third-line agents prior to the end of the SAGE-547 or placebo infusion and remain off all third-line agents for >=24 hours after the end of the study drug infusion. The primary analysis was a comparison between SAGE-547 and placebo of the proportion of responders.|Up to 21 days|The Intent-to-Treat Analysis Set included all participants who had an infusion of blinded study drug initiated. Here, overall number of participants analyzed (N) indicates participants analyzed for this outcome measure.|||days||Full Range|Median
2574719|NCT02477618|Primary|Number of Participants Able to be Weaned Off All Third-Line Agents Prior to End of Double-Blind SAGE-547 or Placebo Infusion, and Remain Off All Third-Line Agents for ≥ 24 Hours Following the End of SAGE-547 or Placebo Infusion|Third-line agents were anesthetic agents that were administered in order to reach a seizure or burst suppression electroencephalogram (EEG) pattern. For this study, third-line agents were defined as continuous intravenous infusions of pentobarbital/thiopental, midazolam, propofol, and ketamine at maintenance doses alone or in combination sufficient to produce a burst or seizure suppression pattern on the EEG. A responder was a participant who was able to be weaned off all third-line agents prior to the end of the SAGE-547 or placebo infusion and remain off all third-line agents for >=24 hours after the end of the study drug infusion. The primary analysis was a comparison between SAGE-547 and placebo of the proportion of responders.|7 days|The Intent-to-Treat Analysis Set included all participants who had an infusion of blinded study drug initiated.|||Participants|||Count of Participants
2574720|NCT02477605|Secondary|Mean Post-operative Pain Rating at Day 1|The subject was asked to rate post-operative pain in the study eye using a score of 0-10, where 0=no pain and 10=the worst pain imaginable.|Day 1 post operative|Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with data.|||units on a scale||Standard Deviation|Mean
2574721|NCT02477605|Secondary|Mean Conjunctival Edema Score at Week 1|Conjunctival edema (swelling) was assessed during examination by the investigator and graded on a scale of 0-3, where 0=Absent and 3=Severe. Each sclerotomy wound was graded as infusion, vitrectomy probe, and illuminator and the average of the three was the overall Conjunctival Edema Score at the visit. Only one eye (study eye) contributed to the analysis.|Week 1 post operative|Intent-to-Treat Set. Number Analyzed is the number of subjects with data.|||units on a scale||Standard Deviation|Mean
2574722|NCT02477605|Primary|Mean Change in Intraocular Pressure (IOP) on Operative Day|IOP (fluid pressure inside the eye) was assessed using the study specified tono-pen and measured in millimeters of mercury (mmHg). Change was defined as the difference between immediate postoperative IOP and immediate preoperative IOP. A greater change in IOP may indicate a less stable posterior chamber and/or a more invasive surgery.|Day 0 preoperative, Day 0 postoperative|Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with data.|||mmHG||Standard Deviation|Mean
2574804|NCT02476422|Secondary|Number of Patients With Any Adverse Events, Serious Adverse Events and Death|Treatment emergent adverse events are reported in the below data table.|time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days)|Safety analyses were performed on the safety set, which included all randomized subjects who were exposed to study drug.|||Participants|||Number
2574723|NCT02477553|Secondary|Number of Patients With High and Low Subjective Numeracy|Subjective numeracy was determined using the Subjective Numeracy Scale (SNS), a validated instrument that involves 8 Likert-type questions regarding the participant's preference for or dislike of numeric information and their perception of their ability to understand it. Each item has a six-point response option from 1-6. The higher the number, the higher the subjective numeracy. All participants were divided into two groups: above (high numeracy) and below (low numeracy) the median for their total subjective numeracy score.|1 day|Subjects who completed the Subjective Numeracy Scale.|||Participants|||Count of Participants
2574724|NCT02477553|Secondary|Decision Conflict: Change in Conflict From Baseline to Post-intervention|Decision conflict is assessed using the16-item Decision Conflict Scale. Scores will range from 0 (low decision conflict) to 100 (high decision conflict). Negative change means decision conflict decreased. A decrease in decision conflict is a better outcome.|1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])|All participants with at least 11 responses to the 16-item Decision Conflict Scale at both baseline (T0) and post-intervention (T1).|||units on a scale||Standard Deviation|Mean
2574725|NCT02477553|Secondary|Knowledge of Colorectal Cancer (CRC) and Colorectal Cancer Screening: Change in Number of Correct Answers From Baseline to Post-intervention|Qualitative knowledge is assessed with five multiple choice and five true/false questions regarding general information (including risk factors, screening test options, and test frequency) of CRC and CRC screening. Knowledge scores were derived by summing correct responses to the 10 individual knowledge questions (range, 0-10), and change from baseline was calculated using the knowledge score at post-intervention minus the knowledge score at baseline. The range for change could be 0 to 10 with higher values meaning an increase in knowledge which is a better outcome.|1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])|All participants who completed at least 7 knowledge questions at both baseline (T0) and post-intervention (T1).|||correct answers||Standard Deviation|Mean
2574726|NCT02477553|Secondary|Perceived Barriers to Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) or Colonoscopy: Change From Baseline to Post-intervention|Assessed separately for colonoscopy (11 questions) and FIT (9 questions), using items drawn from validated scales for measuring barriers and self-efficacy of colonoscopy and FIT. All items had Likert-type response options where 5=strongly agree to 1=strongly disagree. Mean values were calculated within each set of questions (each combined score has a range of 1 to 5) at baseline and post-intervention and then change from baseline was calculated using the mean at post-intervention minus the mean at baseline. The range for change could be -4 to 4 with lower values meaning perceived barriers decreased which is a better outcome.|1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])|Participants who completed both the baseline and post-intervention barrier questions. For colonoscopy, it was 322 in Verbal and 330 in Quantitative. For FIT, it was 321 in Verbal and 327 in Quantitative.|||units on a scale||Standard Deviation|Mean
2574727|NCT02477553|Secondary|Perceived Benefits of Colorectal Cancer Screening With Fecal Immunochemical Test (FIT) and Colonoscopy: Change From Baseline to Post-intervention|Assessed separately for colonoscopy (4 questions) and FIT (4 questions), using items drawn from validated scales for measuring benefits and self-efficacy of colonoscopy and FIT. All items had Likert-type response options where 5=strongly agree to 1=strongly disagree. Mean values were calculated within each set of questions (each combined score has a range of 1 to 5) at baseline and post-intervention and then change from baseline was calculated using the mean at post-intervention minus the mean at baseline. The range for change could be -4 to 4 with higher values meaning perceived benefits increased which is a better outcome.|1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])|Participants who completed both the baseline and post-intervention benefit questions. For colonoscopy, it was 324 in Verbal and 332 in Quantitative. For FIT, it was 320 in Verbal and 330 in Quantitative.|||units on a scale||Standard Deviation|Mean
2574728|NCT02477553|Secondary|Perceived Risk of Colorectal Cancer (CRC): Change From Baseline to Post-intervention|Multiple choice questions assessing subject's perception of how likely they are to get colon cancer in the next 5 years, in the next 10 years, and sometime during their lifetime. Each had response options: 4=very likely, 3=somewhat likely, 2=somewhat unlikely, and 1=very unlikely. The mean of the 3 questions was calculated (each combined score has a range of 1 to 4) at baseline and post-intervention and then change from baseline was calculated using the mean at post-intervention minus the mean at baseline. The range for change could be from -3 to 3 with higher values meaning an increase in perceived risk which is a better outcome.|1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])|All participants with baseline (T0) and post-intervention (T1) perceived risk items. Missing responses were not used.|||units on a scale||Standard Deviation|Mean
2574729|NCT02477553|Primary|Colorectal Cancer (CRC) Screening Intention: Change From Baseline to Post-intervention|Multiple choice question assessing subject's intention in getting a CRC screening test in the next 6 months. The response options were: 5=Definitely, 4=Probably, 3=May or may not, 2=Probably not, and 1=Definitely not. Higher positive change means CRC screening intention increased. Increased intention to be screened is a better outcome.|1 day (baseline [before viewing decision aid] and post-intervention [immediately after viewing decision aid])|All participants with both baseline and post-intervention responses to CRC screening intent items. There were 2 participants in each arm who did not respond to at least one of the intent items.|||units on a scale||Standard Deviation|Mean
2574730|NCT02477553|Primary|Colorectal Cancer (CRC) Screening Completion|Completion of colonoscopy, fecal immunochemical testing (FIT), or other CRC screening test within 6 months of enrollment, based on documentation in the participants' electronic health record. If a patient completed both screening tests and the colonoscopy was a follow-up to a positive FIT, they were considered having completed a FIT only. If the FIT was negative and the patient still had a colonoscopy, they were considered to have completed both tests.|6 months post intervention|All participants who agreed to having their electronic health record (EHR) checked by the researchers. There were 12 participants in the Verbal arm and 4 participants in the Quantitative arm who would not agree for their EHRs to be checked by the researchers; therefore, assessment of uptake was not performed with those participants.|||Participants|||Count of Participants
2574731|NCT02477527|Other Pre-specified|Safety as Measured by Side Effects|Monitor for any side effects that are spontaneously reported by subjects and reported on questionnaires.|24 weeks|no adverse effects reported.|||Participants|||Count of Participants
2574732|NCT02477527|Secondary|Improvements in Sleep Disorder Score|Changes in quality of sleep at week 24 as measured by Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index (PSQI) is used to measure the quality and patterns of sleep in adults. It rates sleep based on seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. It is a self-administered questionnaire covering these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. The scores for the 7 items ranged from 0(none) - 3(severe), and the total score is 0-21. The reported values in the table represent the change in the overall scores on the PSQI scale. The values were added and reported as the sum of the individual measures. A negative score correlates with improvement of the sleep quality.|24 weeks||||units on a scale||Full Range|Mean
2574733|NCT02477527|Secondary|Improvements in Central Nervous System Toxicity Score|"Changes in Central Nervous System toxicity score at week 24 as measured by SSAT 047 scale.~The scale is a questionnaire that participants complete at each visit. The SSAT 047 scores 10 items related to efavirenz side effects including: dizziness, depression, insomnia, anxiety, confusion, impaired concentration, headache, somnolence, aggressive mood and abnormal dreams. The side effects were scored as 0 for None, 1 for Mild, 2 for Moderate and 3 for Severe. The scores for the 10 items ranged from 0(none) - 3(severe), and the total score is 0-30. The scores are then averaged to determine the overall impact on central nervous system symptoms and reported as the sum of the measures."|24 weeks||||units on a scale||Full Range|Mean
2574734|NCT02477527|Secondary|T-cell Changes|Change in CD4 Cell count from baseline to 24 weeks.|24 weeks|Participants completing the study.|||cells / cc||Full Range|Mean
2574735|NCT02477527|Primary|Percentage of Patients With Viral Loads < 50 Following the Switch|percentage of patients with viral loads < 50 following the switch at 24 weeks.|24 weeks|Participants completing the study.|||Participants|||Count of Participants
2574736|NCT02477332|Secondary|ISS7=0 Response: at Week 20 Measured Over 7 Days|"Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.~Complete itch response defined as ISS7 = 0.~Itch Severity Score scale:~0 - None~- Mild (minimal awareness, easily tolerated)~- Moderate (definite awareness, bothersome but tolerable)~- Severe (difficult to tolerate)"|Week 20|Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 & 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.|||participants|||Number
2574737|NCT02477332|Secondary|Complete Itch Response (ISS7=0) Rate at Week 12 Measured Over 7 Days|"Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.~Complete itch response defined as ISS7 = 0.~Itch Severity Score scale:~0 - None~- Mild (minimal awareness, easily tolerated)~- Moderate (definite awareness, bothersome but tolerable)~- Severe (difficult to tolerate)"|Week 12|Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 & 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.|||participants|||Number
2574738|NCT02477332|Secondary|UAS7=0 Response: at Week 20 Measured Over 7 Days|"UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.~Complete urticaria activity response is defined as UAS7 = 0."|Week 20|Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 & 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.|||participants|||Number
2574739|NCT02477332|Secondary|Complete Urticaria Activity Score Response (UAS7=0) Rate at Week 12 Measured Over 7 Days|"UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.~Complete urticaria activity response is defined as UAS7 = 0."|Week 12|Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 & 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.|||Participants|||Number
2574740|NCT02477332|Secondary|Change From Baseline in Urticaria Activity Score (UAS7) at Week 20 Measured Over 7 Days|UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.|Week 20|Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 & 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.|||Score on a scale||95% Confidence Interval|Median
2574741|NCT02477332|Secondary|Change From Baseline in Urticaria Activity Score (UAS7) at Week 12 Measured Over 7 Days|UAS7 is the sum of the HSS7 and the ISS7 scores. The possible range of the weekly UAS7 score is 0 to 42.|Week 12|Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 & 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.|||Score on a scale||95% Confidence Interval|Median
2574742|NCT02477332|Secondary|Change From Baseline in Itch Severity Score (ISS7) at Week 20 Measured Over 7 Days|"Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.~Itch Severity Score scale:~0 - None~- Mild (minimal awareness, easily tolerated)~- Moderate (definite awareness, bothersome but tolerable)~- Severe (difficult to tolerate)"|Week 20|Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 & 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.|||Score on a scale||95% Confidence Interval|Median
2574743|NCT02477332|Secondary|Change From Baseline in Itch Severity Score (ISS7) at Week 12 Measured Over 7 Days|"Itch Severity Score (ISS) is on a scale of 0 to 3. A weekly score (ISS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.~Itch Severity Score scale:~0 - None~- Mild (minimal awareness, easily tolerated)~- Moderate (definite awareness, bothersome but tolerable)~- Severe (difficult to tolerate)"|Week 12|Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 & 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.|||Score on a scale||95% Confidence Interval|Median
2574744|NCT02477332|Secondary|Change From Baseline in Hives Severity Score (HSS7) at Week 20 Measured Over 7 Days|"Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.~Hives Severity Score scale:~0 - None~- Mild (1-6 hives/12 hours)~- Moderate (7-12 hives/12 hours)~- Severe (>12 hives/12 hours)"|Week 20|Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 & 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.|||Score on a scale||95% Confidence Interval|Median
2574745|NCT02477332|Secondary|HSS7=0 Response: at Week 20 Measured Over 7 Days|"Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.~Complete hives response defined as HSS7 = 0.~Hives Severity Score scale:~0 - None~- Mild (1-6 hives/12 hours)~- Moderate (7-12 hives/12 hours)~- Severe (>12 hives/12 hours)"|Week 20|Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 & 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.|||Participants|||Number
2574746|NCT02477332|Secondary|Change From Baseline in Hives Severity Score (HSS7) at Week 12 Measured Over 7 Days|"Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.~Hives Severity Score scale:~0 - None~- Mild (1-6 hives/12 hours)~- Moderate (7-12 hives/12 hours)~- Severe (>12 hives/12 hours)"|Week 12|Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 & 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.|||Score on a scale||95% Confidence Interval|Median
2574747|NCT02477332|Secondary|Complete Hives Response (HSS7=0) Rate at Week 12 Measured Over 7 Days|"Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the 7 days preceding the visit. The possible range of the weekly score is therefore 0 to 21.~Complete hives response defined as HSS7 = 0.~Hives Severity Score scale:~0 - None~- Mild (1-6 hives/12 hours)~- Moderate (7-12 hives/12 hours)~- Severe (>12 hives/12 hours)"|Week 12|Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered. As per protocol and SAP, for the efficacy endpoints at Week 12 or Week 20, only the QGE031 24, 72 & 240 mg, omalizumab 300 mg and placebo arms were analyzed for efficacy comparison between treatment groups.|||Particpants|||Number
2574748|NCT02477332|Primary|Percentage of Participants With Complete Hives Response (HSS7=0)|"The primary objective was to establish the dose-response relationship of ligelizumab (24, 72 and 240 mg every 4 weeks) with respect to achievement of complete hives response (HSS7=0) at Week 12 and select an appropriate dose (or range of doses) which is likely to be superior to omalizumab at the highest approved dose (300 mg every 4 weeks).~Hives Severity Score (HSS) is on a scale of 0 to 3. A weekly score (HSS7) is derived by adding up the average daily scores of the preceding 7 days, with a possible range of 0 - 21.~Hives Severity Score scale:~0 - None~- Mild (1-6 hives/12 hours)~- Moderate (7-12 hives/12 hours)~- Severe (>12 hives/12 hours)~To confirm an overall dose-response signal based on MCP-Mod, and to estimate the minimal ligelizumab dose that shows a relevant superior effect over omalizumab, based on the selected dose response model, the lowest ligelizumab dose that provides a response rate 15% higher than the response of omalizumab 300 mg."|Week 12|Full analysis set (FAS) included all randomized patients, removing misrandomized patients provided that study drug was not administered.|||Percentage of participants||95% Confidence Interval|Number
2574749|NCT02477215|Secondary|Number of Participants Experiencing Dose-Limiting Toxicity (DLT)|A 3+3 design was employed. At each dose, three patients were initially evaluated. If no dose limiting toxicities were observed, the bendamustine dose was increased; if one dose limiting toxicity is observed, three additional patients were treated at that dose. A dose at which 2 DLTs were observed in 3 or 6 patients were judged to be too toxic and the lower dose was defined as the maximally tolerated dose (MTD).|Six months||||Participants|||Count of Participants
2574750|NCT02477215|Secondary|Duration of Response (DoR)|Median time in months participants maintain CR, PR or stable disease.|36 months|Subjects receiving the fixed dose of 80 mg/m^2 Bendamustine were included in this analysis. Results from five of the subjects in the Dose Escalation Phase of this study who also received 80 mg/m^2 Bendamustine were included in the analysis. One of the Dose Expansion Phase subjects did not complete sufficient dosing cycles for inclusion.|||MONTHS||Full Range|Median
2574751|NCT02477215|Secondary|Cumulative Response Rates in Patients After Eight Cycles.|Percentage of subject response rates at any point during the eight cycles.|18 months|Subjects receiving the fixed dose of 80 mg/m^2 Bendamustine were included in this analysis. Results from five of the subjects in the Dose Escalation Phase of this study who also received 80 mg/m^2 Bendamustine were included in the analysis. One of the Dose Expansion Phase subjects did not complete sufficient dosing cycles for inclusion.|||percentage of participants|||Number
2574752|NCT02477215|Secondary|Progression Free Survival (PFS)|This measure is the number of months participants remain free from evidence of disease.|18 months|For this analysis, all 20 participants who received the fixed dose of 80 mg/m^2 Bendamustine and all 8 participants who received Bendamustine (80 mg/m^2) in the Dose Escalation phase, were combined.|||MONTHS||95% Confidence Interval|Median
2574753|NCT02477215|Secondary|Overall Survival (OS)|Overall survival was determined as the average number of months subjects survived following enrollment.|36 months|Subjects receiving the fixed dose of 80 mg/m^2 Bendamustine were included in this analysis. Results from five of the subjects in the Dose Escalation Phase of this study who also received 80 mg/m^2 Bendamustine were included in the analysis. One of the Dose Expansion Phase subjects did not complete sufficient dosing cycles for inclusion.|||MONTHS||95% Confidence Interval|Median
2574754|NCT02477215|Primary|Objective Response Rate|Objective response rate was defined as the number of subjects achieving a complete response (CR) or partial response (PR) after at least four cycles of ixazomib (MLN9708) and bendamustine plus dexamethasone.|18 months|Subjects receiving the fixed dose of 80 mg/m^2 Bendamustine were included in this analysis. Results from five of the subjects in the Dose Escalation Phase of this study who also received 80 mg/m^2 Bendamustine were included in the analysis. One of the Dose Expansion Phase subjects did not complete sufficient dosing cycles for inclusion.|||participants|||Number
2574755|NCT02477215|Primary|Maximum Tolerated Dose of Bendamustine|Maximum tolerated dose of bendamustine in combination with fixed doses of ixazomib (MLN9708) and dexamethasone will be determined from the incidence of dose limiting toxicities at each dosage.|Six months for each dosing cohort|All participants received at least ne dose of Bendamustine at either 70 mg/m^2, 80 mg^2 or 90 mg/m^2.|||mg/m^2|||Number
2574756|NCT02477020|Secondary|Change From Baseline in the University of California San Diego Performance-based Skills Assessment - Brief Version (UPSA-B) at Week 3 and 6|The UPSA-B evaluates the abilities of individuals to perform everyday tasks that are considered necessary for independent functioning in the community. The UPSA-B uses role playing situations to evaluate skills in 5 areas: household chores, communication, finance, transportation, and planning recreational activities. Subscale scores range from 0 to 20 points, and total scores range from 0 to 100 points; higher scores reflect better performance. Least square mean and standard error values were determined using a MMRM. A positive change from Baseline indicates improvement.|Baseline, Weeks 3 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||score on a scale||Standard Error|Least Squares Mean
2574757|NCT02477020|Secondary|Change From Baseline in the Personal and Social Performance (PSP) Scale Score at Weeks 3 and 6|The PSP scale is a clinician-reported outcome instrument that was developed to evaluate social and personal functioning. It measures 4 domains of social functioning: socially useful activities including work and study, personal and social relationships, self-care and disturbing and aggressive behaviors. The clinician assigns an initial 6-degree of severity to each area (absent, mild, manifest, marked, severe or very severe). The final result is a single assessment of social functioning ranging from 0 (no autonomy) to 100 (excellent functioning). Least square mean and standard error values were determined using a MMRM. A positive change from Baseline indicates improvement.|Baseline, Weeks 3 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||score on a scale||Standard Error|Least Squares Mean
2574758|NCT02477020|Secondary|Change From Baseline in Brief Negative Symptom Scale (BNSS) Score at Weeks 3 and 6|The BNSS is a13-item instrument designed for use in clinical trials and other studies that measures 5 domains of negative symptoms: blunted affect, alogia, asociality, anhedonia, and avolition. All the items in the BNSS are rated on a 7-point (0-6) scale, with anchor points generally ranging from the symptom's being absent (0) to severe (6). A scale total score is calculated by summing the 13 individual items; total score range of 0 to 78, where higher score indicates higher severity of negative symptoms. Least square mean and standard error values were determined using a MMRM. A negative change from Baseline indicates improvement.|Baseline, Weeks 3 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||score on a scale||Standard Error|Least Squares Mean
2574759|NCT02477020|Secondary|Change From Baseline in Brief Assessment of Cognition in Schizophrenia (BACS) Score at Weeks 3 and 6|BACS is specifically designed to measure treatment- related improvements in cognition and includes alternate forms. The battery of tests in the BACS includes brief assessments of reasoning and problem solving, verbal fluency, attention, verbal memory, working memory, and motor speed. The primary measure from each test of the BACS is standardized by creating z-scores whereby the mean of the test session of a healthy participant is set to 0 and the standard deviation set to 1. A composite score was calculated by averaging all of the 6 standardized primary measures from the BACS, and then calculating a z-score of the composite. The composite z-score indicates how much higher or lower the participant's cognition is compared to a healthy person. Least square mean and standard error values were determined using a MMRM.|Baseline, Weeks 3 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||z-score||Standard Error|Least Squares Mean
2574760|NCT02477020|Secondary|Percentage of Responders Based on CGI-I Ratings Score|Responder based on CGI-I is defined as a rating of much improved or very much improved. The CGI-I assesses the participant's improvement (or worsening). The clinician is required to assess the participant's condition relative to baseline on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|Weeks 1, 2, 3, 4, 5 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||percentage of participants|||Number
2574779|NCT02476890|Secondary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event|A secondary endpoint of the trial was the percentage of participants receiving gefapixant 100 mg and placebo who discontinued from the study due to an AE. The percentage of participants who discontinued from the study due to an AE was assessed for days 1-4.|Up to Day 4|The analyzed population was all randomized participants who took at least 1 dose of study treatment and had assessment of discontinuation due to an AE.|||Percentage of participants|||Number
2574761|NCT02477020|Secondary|Clinical Global Impression Scale - Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 5 and 6|The CGI-I assesses the participant's improvement (or worsening). The clinician is required to assess the participant's condition relative to baseline on a 7-point scale. CGI-I scale assesses the participant's improvement (or worsening) on a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. Least square mean and standard error values were calculated using a MMRM.|Weeks 1, 2, 3, 4, 5 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||score on a scale||Standard Error|Least Squares Mean
2574762|NCT02477020|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Weeks 1, 2, 3, 4, 5,and 6|The CGI-S is a clinician rated scale designed to assess global severity of illness. CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment. A participant is assessed on severity of mental illness on the following scale: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. Least square mean and standard error values were determined using a MMRM. A negative change from Baseline indicates improvement.|Baseline, Weeks 1, 2, 3, 4, 5 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||score on a scale||Standard Error|Least Squares Mean
2574763|NCT02477020|Secondary|Percentage of Clinical Responders Based on the PANSS Total Score|Clinical responders based on the PANSS total score is defined as at least 30% improvement from baseline in the total score. PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.|Weeks 1, 2, 3, 4, 5 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||percentage of participants|||Number
2574764|NCT02477020|Secondary|Change From Baseline in PANSS Subscales at Weeks 1, 2, 3, 4, 5 and 6|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Positive subscale consists of 7 items which assesses the positive symptoms with subscale score ranging from 7 to 49, where higher score indicates greater severity. Negative subscale consists of 7 items which assesses the negative symptoms with subscale score ranging from 7 to 49, where higher score indicates greater severity. General psychopathology subscale consists of 16 items which assesses the general symptoms of schizophrenia with subscale score ranging from 16 to 96, where higher score indicates greater severity. Least square mean and standard error values were determined using a MMRM. A negative change from Baseline indicates improvement.|Baseline and Weeks 1, 2, 3, 4, 5 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||score on a scale||Standard Error|Least Squares Mean
2574765|NCT02477020|Secondary|Change From Baseline in PANSS Subscales Using the Marder 5-factor Model at Weeks 1, 2, 3, 4, 5, and 6|PANSS subscales using the Marder 5-factor model include positive symptoms (8-items, total score = total score = 8 to 56, with a higher score indicating greater severity of symptoms), negative symptoms (7-items, total score = 7 to 49, with a higher score indicating greater severity of symptoms), disorganized thoughts (7-items, total score = 7 to 49, with a higher score indicating greater severity of symptoms), impulsivity/hostility (4-items, total score = 4 to 28, with a higher score indicating greater severity of symptoms), anxiety/depression (4-items, total score = 4 to 28, with a higher score indicating greater severity of symptoms). Responses to each item range from 1 = absence of symptom, to 7 = most extreme symptoms. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline and Weeks 1, 2, 3, 4, 5 and 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||score on a scale||Standard Error|Least Squares Mean
2574766|NCT02477020|Secondary|Change From Baseline in PANSS Total Score at Weeks 1, 2, 3, 4 and 5|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity. Least square mean and standard error values were determined using a MMRM. A negative change from Baseline indicates improvement.|Baseline and Weeks 1, 2, 3, 4 and 5|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here ‘n’ refers to number of participants analyzed at each time point.|||score on a scale||Standard Error|Least Squares Mean
2574767|NCT02477020|Primary|Change From Baseline in the Positive and Negative Symptom Scale (PANSS) Total Score at Week 6|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity. Least square mean and standard error values were determined using a mixed model for repeated measures (MMRM). A negative change from Baseline indicates improvement.|Baseline and Week 6|The full analysis set included all participants who were randomized, received at least one dose of study drug and have a baseline value and at least one valid postbaseline value for assessment of primary efficacy. Here number of participants analyzed are participants evaluable for this outcome measure.|||score on a scale||Standard Error|Least Squares Mean
2574780|NCT02476890|Secondary|Percentage of Participants Who Experienced One or More Adverse Events During Study Treatment and Follow up|A secondary endpoint of the trial was the percentage of participants receiving gefapixant 100 mg and placebo who had at least 1 adverse event (AE) over 4 days of treatment (including washout periods) in addition to 14 days (+3 days) until a post-treatment follow-up visit. An AE is defined as any untoward medical occurrence in a participant administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an AE. The percentage of participants in any treatment group with at least 1 AE was assessed.|Up to Day 18|The analyzed population was all randomized participants who took at least 1 dose of study treatment and had assessment of AE occurrence.|||Percentage of participants|||Number
2574781|NCT02476890|Secondary|Change From Baseline in Cough Frequency After Cough Challenge Testing in Participants Who Received Gefapixant 100 mg and Placebo (Chronic Cough Participants Only)|An ambulatory cough recording device recorded all sounds chronic cough participants made during cough monitoring to measure the change from baseline in objective cough frequency on the treatment days. A negative change from Baseline was considered to indicate improvement in cough frequency|Baseline and for 24 hours after cough challenge on treatment days|The analyzed population was all treated chronic cough participants who had at least 1 post-dose primary endpoint assessment of cough frequency.|||Counts/hr||95% Confidence Interval|Least Squares Mean
2574782|NCT02476890|Secondary|Change From Baseline in Urge to Cough VAS After Cough Challenge Testing in Participants Who Received Gefapixant 100 mg and Placebo (Chronic Cough Participants Only)|Chronic cough participants completed a VAS to record the severity of their urge to cough, prior to dosing on the treatment day in each treatment period, and one hour after the final cough challenge on the treatment days. Participants marked the 100mm VAS at the extremes as 'No urge-to-cough' (0) and 'Worst urge-to-cough' (100). Participants were instructed to draw a single vertical line on the scale to indicate how severe their urge to cough was during the previous 1 hour on the treatment days. A negative change from Baseline was considered to indicate improvement in urge to cough.|Baseline and one hour after final cough challenge on treatment days|The analyzed population was all treated chronic cough participants who had at least 1 post-dose primary endpoint assessment of urge to cough.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2574783|NCT02476890|Secondary|Change From Baseline in Cough Severity Visual Analogue Scale (VAS) After Cough Challenge Testing in Participants Who Received Gefapixant 100 mg and Placebo (Chronic Cough Participants Only)|Chronic cough participants completed a visual analogue scale (VAS) to record cough severity, prior to dosing on the treatment day in each treatment period, and one hour after the final cough challenge on the treatment days. This was a 100mm VAS of cough severity from 'No Cough' (0) up to 'Worst Cough' (100). Participants were instructed to draw a line on the scale to indicate how severe they felt their cough was during the previous 1 hour on the treatment days. A negative change from Baseline was considered to indicate improvement in cough severity.|Baseline and one hour after the final cough challenge on treatment days|The analyzed population was all treated chronic cough participants who had at least 1 post-dose primary endpoint assessment of cough severity.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2574784|NCT02476890|Primary|Cough Reflex Sensitivity to Distilled Water in Participants Who Received Gefapixant 100 mg and Placebo (Period 1 & Period 2 Combined)|The concentration of distilled water inducing at least 2 coughs (C2) and at least 5 coughs (C5) was assessed at 1, 3, and 5 hours post-dose in healthy and chronic cough participants. The concentrations of distilled water for cough challenge were 20%, 40%, 60%, 80%, and 100%. The Measure Type is least-squares mean in natural log scale. The number of coughs generated in 1 minute of exposure was recorded. The challenge agent was prepared by dilution of distilled water with saline, and was administered by inhalation. A mixed effects model used natural log-transformed values for the lowest concentrations of inhaled solution required to evoke at least 2 (C2) or at least 5 (C5) coughs to estimate the average of C2 or C5 across 3 time points for each treatment group, and to compare treatment difference relative to placebo. When applying the mixed model repeated measure analysis, if there is a missing value for concentration, it was imputed as 1.5 times the maximum concentration (=150%).|Average of 1, 3, and 5 hours post-dose|The analyzed population was all treated participants who had at least 1 post-dose primary endpoint assessment of cough reflex sensitivity in response to distilled water challenge.|||natural log (percent concentration [%])||95% Confidence Interval|Least Squares Mean
2574785|NCT02476890|Primary|Cough Reflex Sensitivity to ATP in Participants Who Received Gefapixant 100 mg and Placebo (Period 1 & Period 2 Combined)|The concentration of ATP inducing at least 2 coughs (C2) and at least 5 coughs (C5) was assessed at 1, 3, and 5 hours post-dose in healthy and chronic cough participants. The concentrations of ATP for cough challenge were 0.1 mM, 0.3 mM, 1 mM, 3 mM, 10 mM, 30 mM, 100 mM, and 300 mM. The Measure Type is least-squares mean in natural log scale. The challenge agent was prepared by dilution of ATP with saline, and was administered by inhalation. A mixed effects model used natural log-transformed values for the lowest concentrations of inhaled solution required to evoke at least 2 (C2) or at least 5 (C5) coughs to estimate the average of C2 or C5 across 3 time points for each treatment group, and to compare treatment difference relative to placebo. When applying the mixed model repeated measure analysis, if there is a missing value for concentration, it was imputed as 1.5 times the maximum concentration (=150%).|Average of 1, 3, and 5 hours post-dose|The analyzed population was all treated participants who had at least 1 post-dose primary endpoint assessment of cough reflex sensitivity in response to ATP challenge.|||natural log (mM)||95% Confidence Interval|Least Squares Mean
2574799|NCT02476565|Secondary|Time to Placement of the Supra Glottic Device|This measure of time begins with the handling of the supra glottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide|Up to 10 minutes|unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis|||seconds||Standard Deviation|Mean
2574800|NCT02476565|Primary|Time to Successful Tracheal Intubation|This measure of time begins with the handling of the supraglottic device to confirming the appropriate placement of the device by noting the presences of end tidal carbon dioxide.|Up to 10 minutes|unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis|||seconds||Standard Deviation|Mean
2574786|NCT02476890|Primary|Cough Reflex Sensitivity to Citric Acid in Participants Who Received Gefapixant 100 mg and Placebo (Period 1 & Period 2 Combined)|The concentration of citric acid inducing at least 2 coughs (C2) and at least 5 coughs (C5) was assessed at 1, 3, and 5 hours post-dose in healthy and chronic cough participants. The concentrations of citric acid for cough challenge were 1 millimoles (mM), 3 mM, 10 mM, 30 mM, 100 mM, 300 mM, 1 M, and 3 M. The Measure Type is least-squares mean in natural log scale. The challenge agent was prepared by dilution of citric acid with saline, and was administered by inhalation. A mixed effects model used natural log-transformed values for the lowest concentrations of inhaled solution required to evoke at least 2 (C2) or at least 5 (C5) coughs to estimate the average of C2 or C5 across 3 time points for each treatment group, and to compare treatment difference relative to placebo. When applying the mixed model repeated measure analysis, if there is a missing value for concentration, it was imputed as 1.5 times the maximum concentration (=150%).|Average of 1, 3, and 5 hours post-dose|The analyzed population was all treated participants who had at least 1 post-dose primary endpoint assessment of cough reflex sensitivity in response to citric acid challenge.|||natural log (mM)||95% Confidence Interval|Least Squares Mean
2574787|NCT02476890|Primary|Cough Reflex Sensitivity to Capsaicin in Participants Who Received Gefapixant 100 mg and Placebo (Period 1 & Period 2 Combined)|The concentration of capsaicin inducing at least 2 coughs (C2) and at least 5 coughs (C5) was assessed at 1, 3, and 5 hours post-dose in healthy and chronic cough participants. The concentrations of capsaicin for cough challenge were 0.3 micromoles (µM), 1 µM, 3 µM, 10 µM, 30 µM, 100 µM, 300 µM, and 1000 µM. The Measure Type is least-squares mean in natural log scale. The challenge agent was prepared by dilution of capsaicin with saline, and was administered by inhalation. A mixed effects model used natural log-transformed values for the lowest concentrations of inhaled solution required to evoke at least 2 (C2) or at least 5 (C5) coughs to estimate the average of C2 or C5 across 3 time points for each treatment group, and to compare treatment difference relative to placebo. When applying the mixed model repeated measure analysis, if there is a missing value for concentration, it was imputed as 1.5 times the maximum concentration (=150%).|Average of 1, 3, and 5 hours post-dose|The analyzed population was all treated participants who had at least 1 post-dose primary endpoint assessment of cough reflex sensitivity in response to capsaicin challenge.|||natural log (µM)||95% Confidence Interval|Least Squares Mean
2574788|NCT02476617|Primary|Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12|The changes from week 0 to post-treatment (PT) week 12 in key ISG expression in PBMCs for participants achieving sustained virologic response 12 weeks PT (SVR12) where SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug. For each key ISG, fold change was defined as the ratio of the difference between PT Week 12 and baseline expressions over the baseline expression.|Week 0 to Post-Treatment Week 12|All participants who achieved SVR12 and had both baseline and post-baseline value at Post-Treatment Week 12 were included in this analyses..|||Fold change||Standard Deviation|Mean
2574789|NCT02476578|Secondary|Impact on a Composite Measure of Medical Treatment|A composite measure of doses of prescribed anti-diabetic and cholesterol-lowering medicines - According to relevant alert by email.|1 year|Data were not collected.||||||
2574790|NCT02476578|Secondary|Impact on Medical Costs|Medical expenses to the medical insurer, including hospitalizations, consultations, examinations, devices and medicines.|1 year|Data were not collected||||||
2574791|NCT02476578|Secondary|Impact on Evaluation Rate|Percentage of patients evaluated by a nurse and counseled by a dietitian|1 year||||Participants|||Count of Participants
2574792|NCT02476578|Primary|Death From Any Cause|Impact on overall-survival|1 year||||Participants|||Count of Participants
2574793|NCT02476565|Other Pre-specified|Visualization Score|"The visualization of each of the following structures provides one point, for a maximum score of 7.~Right true vocal cord.~Left true vocal cord.~Right false vocal cord.~Left false vocal cord.~Right posterior cartilage~Left posterior cartilage~Epiglottis"|Up to 10 minutes||||units on a scale||Standard Deviation|Mean
2574794|NCT02476565|Secondary|Percent of Subjects With 0, 1, 2 and 3 Airway Manipulations Required for Placement of Endotrachial Tube|Percent of subjects with 0, 1, 2 and 3 airway manipulations required for placement of endotrachial tube|Up to 10 minutes|2 participants in I-gel arm were excluded from analysis because times to established safety cutoff for airway establishment(10 minutes) was exceeded. 5 participants in LMA-Supreme arm were excluded in analysis because study was aborted at request of attending or times to established safety cutoff for airway establishment (10 minutes) was exceeded.|||percent of participants|||Number
2574795|NCT02476565|Secondary|Time to Placement of the Endotrotracheal Tube|Time to the appropriate placement of the endotracheal tube.|Up to 10 minutes|unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis|||second||Standard Deviation|Mean
2574796|NCT02476565|Secondary|Percent of Subjects Who Required 0, 1, 2, 3 and 6 Airway Manipulations for the Placement of the Aintree.|Percent of subjects who required 0, 1, 2, 3 and 6 airway manipulations for the placement of the Aintree.|Up to 10 minutes|2 participants in I-gel arm were excluded from analysis because times to established safety cutoff for airway establishment(10 minutes) was exceeded. 3 participants in LMA-Supreme arm were excluded in analysis because study was aborted at request of attending or times to established safety cutoff for airway establishment (10 minutes) was exceeded.|||percent of participants|||Number
2574797|NCT02476565|Secondary|Time to Placement of the Aintree Airway Intubation Catheter|This measure of time begins with the handling of the fiberscope to withdrawal of the fiberscope from the Aintree and setting the fiberscope down|Up to 10 minutes|unable to confirm accuracy of data in 1 participant in the I-gel group, that participant's data was not included in the analysis|||seconds||Standard Deviation|Mean
2574798|NCT02476565|Secondary|Percent of Subjects Who Required 0, 1, 2, and 3 Airway Manipulations for the Placement of the Supraglottic Device|Percent of subjects who required 0, 1, 2, and 3 airway manipulations for the placement of the supraglottic device|Up to 10 minutes|4 participants in the LMA-Supreme arm were not included in analysis because the study was aborted at the request of the attending or the times to established safety cutoff for airway establishment (10 minutes) was exceeded.|||percent of participants|||Number
2574805|NCT02476422|Secondary|Number of Patients With Different Responses Based on Patient's Global Assessment of Response to Treatment (PGART)|PGART was measured by asking patients to give a score on a scale from 0 to 4, where 0 = poor; 1 = fair; 2 = good; 3 = very good; 4 = excellent. This measurement was taken at the end of 8 hours, or before the use of rescue medication (for a patient who takes rescue medciation within the 8 hour period).|At 8 hour postdose prior to use of rescue medication|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter.|||Participants|||Number
2574806|NCT02476422|Secondary|Number of Patients Needing Rescue Medication|The number of patients needing rescue medication within the 8 hour treatment period was evaluated.|From dose administration to 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter.|||Participants|||Number
2574807|NCT02476422|Secondary|Duration of Analgesia|Duration of analgesia (time to first use of rescue medication) was evaluated, from dose administration to the time of first use of rescue medication within the 8-hour treatment period. Censored observations were included in calculating this endpoint. Censored subjects include any subject who did not take rescue medication prior to the end of the assessment period of 480 minutes (8 hours).|From dose administration to 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter.|||minutes||Inter-Quartile Range|Median
2574808|NCT02476422|Secondary|Peak Analgesic Effect|"Peak analgesic relief is represented through highest pain intensity difference (PID), highest VASPI reduction, and highest pain relief scores. Pain intensity was measured on a verbal rating scale (VRS) ranging from 0 to 3 (none to severe, with higher score for higher pain intensity). PID represents difference in this score at baseline and specific time points, larger change indicating larger reduction in pain, with highest PID representing the largest difference. Pain relief was recorded on a scale ranging from 0 to 4 (none to complete, with higher score for higher pain relief), with highest pain relief representing maximum relief obtained. Pain intensity was also measured through a 100 mm visual analogue scale (VASPI), ranging from no pain (0 mm) to worst possible pain (100 mm). A positive change in VASPI indicates reduction in pain, with highest VASPI reduction representing highest change."|From dose administration to 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.|||units on a scale||Standard Deviation|Mean
2574809|NCT02476422|Secondary|Summed Total Pain Relief (TOTPAR) at Different Time Points|"After the administration of the single dose of the assigned study treatment, at the defined study time points, the clinical site staff captured pain relief information from each subject.~The subject was asked What is the amount of pain relief as compared to the starting pain? and the response was recorded as 0 = none, 1 = a little, 2 = some, 3 = a lot, or 4 = complete.~Total pain relief (TOTPAR) was the weighted sum of the pain relief scores from the 15-minute to the 8-hour observation points (TOTPAR8). Additionally, TOTPARs at 1, 2, 4 and 6 hours were calculated. The weights used for these values (evaluation time points) were 0.25 for the 15-, 30-, 45-, and 60-minute observations, 0.5 for the 90-minute, 2- and 4-hour observations, and 1 for the remaining observations."|1, 2, 4, 6, and 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.|||units on a scale||Standard Error|Least Squares Mean
2574810|NCT02476422|Secondary|Sum of Pain Intensity Difference (SPID)|"At baseline and at each defined study time point, the clinical site staff captured pain intensity information from each subject using the 4-point categorical VRS. The subject was asked What is your pain level at this time? and the response was recorded as 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Pain intensity difference (PID) was the difference between the baseline pain intensity score and the pain intensity score at a specific observation point. SPID is the weighted sum of PIDs from the 15-minute to the 8-hour observation point (SPID8). Additionally, SPID evaluations were also be done at 1 (SPID1), 2 (SPID2), 4 (SPID4) and 6 (SPID6) hours post dose. The weights used for these values were 0.25 for the 15-, 30-, 45-, and 60-minute observations, and 0.5 for the 90-minute, 2- and 4-hour observations, and 1 for the remaining observations."|1, 2, 4, 6, and 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.|||units on a scale||Standard Error|Least Squares Mean
2574811|NCT02476422|Secondary|Time to Onset of First Perceptible Pain Relief (FPR)|Using the double stopwatch technique, participant started two stopwatches at dosing, and stopped the first stopwatch as soon as he/she first began to feel 'any' relief from pain. The time elapsed was recorded as the FPR.|Within 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter.|||minutes||Inter-Quartile Range|Median
2574812|NCT02476422|Secondary|Time to Onset of Meaningful Pain Relief (MPR)|Using the double stopwatch technique, participant started two stopwatches at dosing, and stopped the second stopwatch as soon as he/she began to experience 'meaningful' relief from pain. Time elapsed is recorded as the MPR.|Within 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter.|||minutes||Inter-Quartile Range|Median
2574813|NCT02476422|Secondary|Time to Confirmed First Perceptible Pain Relief|Time to onset of first perceptible pain relief (FPR), provided the FPR was subsequently 'confirmed' through the achievement of meaningful pain relief (MPR). Participant started two stopwatches at dosing, and recorded FPR by stopping the first stopwatch when he/she first experienced 'any' pain relief. FPR is 'confirmed' only if the participant also stopped the second stopwatch indicating 'meaningful pain relief'.|Within 8 hours postdose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 postdose assessment on any efficacy parameter.|||minutes||Inter-Quartile Range|Median
2574814|NCT02476422|Secondary|Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points|"VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their pain intensity using the 100 mm VASPI to indicate their current level of pain intensity on the 100 mm VASPI labeled no pain (0 mm) as the left anchor and worst possible pain (100 mm) as the right anchor. A positive change shows reduction in pain.~AUC of VASPI reduction from baseline for each time point was calculated using the trapezoidal rule."|15, 30, 45, 60 and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.|||units on a scale*hours||Standard Error|Least Squares Mean
2574815|NCT02476422|Secondary|Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points|"VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their current level of pain intensity on the 100 mm VASPI, labeled no pain (0 mm) as the left anchor and worst possible pain (100 mm) as the right anchor. A positive change represents a reduction in pain."|15, 30, 45, and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose|The efficacy analyses were performed on the full analysis set (FAS), which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.|||Units on a scale||Standard Error|Least Squares Mean
2574816|NCT02476422|Primary|Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at 60 Minutes Post Dose|"VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their current level of pain intensity on the 100 mm VASPI, labeled no pain (0 mm) as the left anchor and worst possible pain (100 mm) as the right anchor. A positive change represents a reduction in pain."|60 minutes postdose|The efficacy analyses were performed on the full analysis set (FAS) which consisted of all randomized subjects who were exposed to study drug and provided at least 1 post-dose assessment on any efficacy parameter. Last observation carried forward (LOCF) was used as the imputation technique.|||units on a scale||Standard Error|Least Squares Mean
2574817|NCT02476357|Secondary|Daily Amount of Drained Lymph|Patients had to record on a list the amount in ml. of lymph in the suction drain bottles|Lymph quantity measured every day, up to 50 days.|One patient in the Harmonic group was excluded due to insufficient data collection of lymph at home|||ml.||Standard Deviation|Mean
2574818|NCT02476357|Primary|Postoperative Draining Time|Duration (days) between surgery and removal of postoperative suction drain|Lymph quantity measured every day. Drained removed when < 50 ml. per day for 2 consecutive days||||days||Standard Deviation|Mean
2574819|NCT02476175|Secondary|Number of Participants Without Variation in Heart Rate|Cardiovascular safety: mean difference in heart rate (with variation in heart rate increase of more than 20%). Heart rate was taken at initiation of study drug, at each visit and at the study end.|Participants will be followed for the duration of the study, up to 52 weeks||||Participants|||Count of Participants
2574820|NCT02476175|Secondary|Number of Participants Showing Improved Quality of Life Using the Patient Perception of Bladder Condition Scale and Voiding Diaries|"Effectiveness will also be assessed using the Patient Perception of Bladder Condition (PPBC) scale on a 6-point scale ranging from 1 to 6 ( 1 is the best score and 6 is the worst score), at study initiation, every visit and at the study end.~Results will be documented based on subjective relief of symptoms and objective voiding diaries.~Participants perception of bladder condition score at initiation of treatment was:4 and at last follow up score was: 2."|Participants will be followed for the duration of the study, up to 52 weeks||||Participants|||Count of Participants
2574821|NCT02476175|Secondary|Number of Participants With Cardio Vascular Safety|Cardiovascular safety: mean difference in blood pressure (Variation in blood pressure: systolic ±20 mmHg, diastolic ±15 mmHg), blood pressure was taken at each visit and at the study end.|Participants will be followed for the duration of the study, up to 52 weeks||||Participants|||Count of Participants
2574822|NCT02476175|Primary|Number of Participants With Grade 2 or 3 Urgency Episodes as a Measure of Efficacy|On voiding diary, participants described their urgency according to the Canadian Urological Association voiding diary, range 0 to 3 at study entry and at study end.|up to 52 weeks||||Participants|||Count of Participants
2574823|NCT02476175|Primary|Response to Urinary Incontinence as a Composite Measure of Efficacy of add-on Mirabegron|Results were based on the International Children's Continence Sociéty classification. Parents or patients supervised by their parents rated symptom relief on a questionnaire as complete cure (definied as dryness) or partial response (reduction of 50% to 99% in incontinence episodes).|up to 52 weeks||||Participants|||Count of Participants
2574824|NCT02476032|Secondary|Verbal Rating Scale: Mean Reduction in Sensitivity Between Groups|"An analysis of covariance model was used to compare mean reduction in sensitivity scores (SAS and VRS) between groups at each post-treatment time point. A linear mixed effect model with group, time and baseline score as fixed effects and a random subject effect was used to compare the sensitivity outcomes between groups across time. The effect of location was also examined using this model.~Verbal Rating Scale 0-10 Measurement of Participant's Perception of Pain~0 = No pain 1-3 = Mild Pain 4-6 = Moderate Pain 7-10 = Severe Pain"|30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline||||units on a scale||Standard Error|Mean
2574825|NCT02476032|Primary|Schiff Air Test: Mean Reduction in Sensitivity Between Groups|"An analysis of covariance model was used to compare mean reduction in sensitivity scores (SAS and VRS) between groups at each post-treatment time point. A linear mixed effect model with group, time and baseline score as fixed effects and a random subject effect was used to compare the sensitivity outcomes between groups across time. The effect of location was also examined using this model.~Schiff Air Scale 0-3 Measurement of Dentinal Hypersensitivity~0 Tooth/Patient did not respond to the air stimulus~Tooth/Patient responded to the air stimulus but did not request discontinuation of the stimulus~Tooth/Patient responded to the air stimulus and request discontinuation or moved from the stimulus~Tooth/Patient responded to the air stimulus, considered the stimulus painful, and requested discontinuation of the stimulus"|30 Minutes Post, 4 Weeks Post, 8 Weeks Post Baseline||||units on a scale||Standard Error|Mean
2574826|NCT02476006|Secondary|Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use|SIAQ: contained 2 modules: Pre-SIAQ and Post-SIAQ. Post-SIAQ: self-completed after self-injection. Post-SIAQ consisted of 21 items grouped into 6 domains: feelings about injections, self-image, self-confidence, injection-site reactions, ease of use & satisfaction with self-injection. Participants rated each item on 5-point (or 6-point) semantic Likert-type scale, where lower numbers indicated a worse experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item. Transformed scores for items contributing to a domain were then averaged into a domain score. Each domain score ranges from 0 (worst experience) to 10 (best experience), higher score=better acceptability. Domain scores which are not in common with Pre-SIAQ were analyzed on the Post-SIAQ population and are reported here.|Week 4, Week 8, Week 12, Week 24, Week 48, Week 72, Week 96|POST-SIAQ population: participants from safety population who self-injected at least once during the study and completed a POST-SIAQ regardless of completion of PRE-SIAQ. Here, number analyzed = participants with available data at specified time points.|||units on a scale||Standard Deviation|Mean
2574827|NCT02476006|Secondary|Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections|Pre-SIAQ: self-completed before first self-injection & Post-SIAQ: self-completed after self-injection. Pre-SIAQ consisted of 7 items grouped into 3 domains:feelings about injections,self-confidence & satisfaction with self-injection. Post-SIAQ consisted of 21 items grouped into 6 domains:feelings about injections,self-image,self-confidence,injection-site reactions,ease of use & satisfaction with self-injection. Participants rated each item on 5-point (or 6-point) semantic Likert-type scale, where lower numbers indicate a worse experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience). Transformed scores for items contributing to a domain were then averaged into a domain score. Each domain score ranges from 0 (worst experience) to 10 (best experience), higher score=better acceptability. Domain scores common to the Pre & Post SIAQ were analyzed on participants belonging to Pre & Post-SIAQ population and are reported.|Baseline (Pre-SIAQ), Week 4, Week 8, Week 12, Week 24, Week 48, Week 72, Week 96|Pre and Post-SIAQ population: participants from the safety population who self-injected the training injection & completed a Pre-SIAQ before first self-injection, who self-injected study drug at least once during the study and completed a Post-SIAQ. Here, number analyzed = participants with available data at specified time points.|||units on a scale||Standard Deviation|Mean
2574828|NCT02476006|Secondary|Percent Change From Baseline in Triglycerides at Week 12|Baseline value was defined as the last observation before the first dose of the treatment.|Baseline, Week 12|Analysis was performed on mITT population.|||percent change||Standard Deviation|Mean
2574829|NCT02476006|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12|Baseline value was defined as the last observation before the first dose of the treatment.|Baseline, Week 12|Analysis was performed on mITT population.|||percent change||Standard Deviation|Mean
2574830|NCT02476006|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12|Baseline value was defined as the last observation before the first dose of the treatment.|Baseline, Week 12|Analysis was performed on mITT population.|||percent change||Standard Deviation|Mean
2574831|NCT02476006|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12|Baseline value was defined as the last observation before the first dose of the treatment.|Baseline, Week 12|Analysis was performed on mITT population.|||percent change||Standard Deviation|Mean
2574832|NCT02476006|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) and/or >=50% Reduction From Baseline in LDL-C at Week 12|LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached LDL-C <70 mg/dL at Week 12 and/or >=50% reduction from baseline in LDL-C at Week 12 are reported.|At Week 12|Analysis was performed on mITT population.|||percentage of participants||95% Confidence Interval|Number
2574833|NCT02476006|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 12|LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached calculated LDL-C <70 mg/dL (1.81 mmol/L) at week 12 were reported.|At Week 12|Analysis was performed on mITT population.|||percentage of participants||95% Confidence Interval|Number
2574834|NCT02476006|Secondary|Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 12|LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached calculated LDL-C <100 mg/dL (2.59 mmol/L) at week 12 were reported.|At Week 12|Analysis was performed on mITT population.|||percentage of participants||95% Confidence Interval|Number
2574835|NCT02476006|Secondary|Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 12|Calculated LDL-C values were obtained using the Friedewald formula. Calculated LDL-C in mg/dL from Friedewald formula (LDL cholesterol = Total cholesterol - HDL cholesterol - [Triglyceride/5]). Baseline value was defined as the last observation before the first dose of the treatment.|Baseline, Week 12|Analysis was performed on modified intent-to-treat population (mITT): all enrolled participants who received at least one dose or part of a dose of alirocumab and had an evaluable efficacy endpoint during the efficacy treatment period (defined as time period from the first injection of alirocumab up to the day of last injection +21 days).|||percent change||Standard Deviation|Mean
2574836|NCT02476006|Primary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse Event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Treatment-emergent AEs (TEAEs) were defined as AEs that that developed or worsened or became serious during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.|From first injection of investigational medicinal product (IMP) up to 2 weeks after last dose of study drug (Week 120)|Analysis was performed on safety population.|||percentage of participants|||Number
2574838|NCT02475980|Secondary|Descriptive Statistics of Participants|Frequencies and descriptive statistics of participant demographics, comorbidities associated with unintended adolescent pregnancy, and contraceptive use|At conclusion of study data collection, approximately 8 weeks after enrollment|Participants consented for project|||participants|||Number
2574839|NCT02475980|Primary|Contraceptive Initiation|Proportion of participants who report initiating contraception or changing to a more effective method of contraception|4 weeks after enrollment|Of the 13 girls consented to the study, 1 initiated a new contraception method following the intervention.|||participants|||Number
2574840|NCT02475980|Primary|Participant Satisfaction|Participant ratings of acceptability of contraceptive counseling in the emergency department and satisfaction with counseling|4 weeks after enrollment|Number of girls available for follow-up at 4-week phone call.|||participants|||Number
2574841|NCT02475980|Primary|Proportion of Eligible Girls Offered Counseling Intervention|Proportion of girls eligible to participate in study who were offered contraceptive counseling|Approximately 4 weeks after enrollment||||participants|||Number
2574842|NCT02475980|Primary|Length of Stay|Emergency department length of stay for participants|Measured at time of chart review for patient follow-up, approximately 4 weeks after enrollment.||||minutes||Full Range|Median
2574843|NCT02475837|Secondary|Count of All Participants With Bleeding Events|Bleeding events according to GUSTO (criteria for bleeding: Severe, Moderate or Mild) and BARC (bleeding criteria Type 0-5, with 0 being no bleeding and 5 referring to probable or definite fatal bleeding) Criteria|up to 238 days|Pre-specified time for assessment of this Outcome Measure was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.|||Participants|||Count of Participants
2574844|NCT02475837|Secondary|Count Participants With AV Fistula Patency|Criteria for outcome: AV fistula patency at 150-180 days, with at least 50% increase in vein diameter by ultrasound compared with preoperative vein diameter measurement.|150-238 days|Pre-specified time for assessment of this Outcome Measure was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.|||Participants|||Count of Participants
2574845|NCT02475837|Secondary|Count of Participants With AV Fistula Use|Participants able to use their AV fistula for dialysis within 180 days of surgery were considered to have met the outcome.|up to 238 days|Pre-specified time for assessment of this Outcome Measure was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.|||Participants|||Count of Participants
2574846|NCT02475837|Primary|Time to AV Fistula Functional Maturation|Time to AV fistula functional maturation (defined as successful cannulation of the AV fistula for six hemodialysis sessions within three weeks).|up to 238 days|Pre-specified time for assessment of this Outcome Measure was up to 180 days, but data collected is out of window due to delayed and rescheduled visits.|||Days to functional maturation||Inter-Quartile Range|Median
2574847|NCT02475733|Secondary|Percentage of Participants With Emergent Infections at Test of Cure (TOC) Visit: Microbiologically Evaluable Population|Emergent Infections was an intra-abdominal culture identified pathogen other than a baseline pathogen during the course of active treatment with study therapy along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy, new infection was an intra-abdominal culture identified pathogen other than a baseline pathogen at any time after study treatment has finished along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). Participants with any (super infections or new infections) of the infections were reported.|TOC visit (up to a maximum study duration of 50 days)|ME analysis population included randomized participants with cIAI who received study medication for >=48 h and clinical failure or clinical failure with treatment limiting AE and participants with >=72 h treatment and favorable microbiological response.|||percentage of participants|||Number
2574848|NCT02475733|Secondary|Percentage of Participants With Emergent Infections: Microbiological Intent-to-treat (Micro-ITT) Population|Emergent infections were categorized as super infections and new infections. Superinfection: An intra-abdominal culture identified pathogen other than a baseline pathogen during the course of active treatment with study therapy along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. New infection: An intra-abdominal culture identified pathogen other than a baseline pathogen at any time after study treatment had finished along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. Participants with any (super infections or new infections) of the infections were reported.|Baseline up to 50 days|Micro-ITT analysis population included all randomized participants who had a baseline pathogen known to cause cIAI.|||percentage of participants|||Number
2574849|NCT02475733|Secondary|Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Microbiologically Evaluable (ME) Population|A participant was said to have clinical relapse if me either 1 of the following criteria: reappearance or worsening of signs and symptoms of cIAI that required further antimicrobial therapy and/or surgery, or death after TOC in which cIAI was contributory. LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).|LFU visit (up to a maximum study duration of 50 days)|ME analysis population included randomized participants with cIAI who received study medication for >=48 h and clinical failure or clinical failure with treatment limiting AE and participants with >=72 h treatment and favorable microbiological response. Here, number of participants analyzed=participants who were evaluable for this measure.|||percentage of participants|||Number
2574850|NCT02475733|Secondary|Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Clinically Evaluable (CE) Population|A participant was said to have clinical relapse if met either 1 of the following criteria: reappearance or worsening of signs and symptoms of cIAI that required further antimicrobial therapy and/or surgery, or death after TOC in which cIAI was contributory. LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).|LFU visit (up to a maximum study duration of 50 days)|CE analysis population included randomized participants with cIAI who received study medication for >=48h and clinical failure or clinical failure with treatment limiting AE and participants with >=72h treatment and favorable clinicial response. Here, number of participants analyzed=participants who were evaluable for this measure.|||percentage of participants|||Number
2574921|NCT02475629|Secondary|Mean Change in Viral Load as a Measure of Efficacy - Protocol Correct|Mean change from Day 7/Baseline in Log 10 viral load measured at Day 14|Day 7 and Day 14|Protocol Correct (PC) Population (all participants with non-missing viral load assessments at Day 14|||Log10 copies/mL||Standard Deviation|Mean
2574851|NCT02475733|Secondary|Percentage of Participants With Favorable Microbiological Response: Microbiologically Evaluable (ME) Population|Favorable microbiological response was achieved when all baseline pathogens were eradicated or presumed eradicated based on investigator's discretion. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study if on oral switch therapy (which occurred within the maximum study treatment duration of 15 days). TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).|EOIV visit (Day 4 up to 16), EOT visit (up to Day 17), TOC visit (up to a maximum study duration of 50 days) and LFU visit (up to a maximum study duration of 50 days)|ME analysis population included randomized participants with cIAI who received study medication for >=48h and clinical failure or clinical failure with treatment limiting AE and participants with >=72h treatment and favorable microbiological response.|||percentage of participants|||Number
2574852|NCT02475733|Secondary|Percentage of Participants With Favorable Microbiological Response: Microbiological Intent-to-treat (Micro-ITT) Population|Favorable microbiological response was achieved when all baseline pathogens were eradicated or presumed eradicated based on investigator's discretion. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study if on oral switch therapy (which occurred within the maximum study treatment duration of 15 days). EOIV visit occurred within 24 hours after completion of last infusion of the study drug. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).|EOIV visit (Day 4 up to 16), EOT visit (up to Day 17), TOC visit (up to a maximum study duration of 50 days) and LFU visit (up to a maximum study duration of 50 days)|Micro-ITT analysis population included all randomized participants who had a baseline pathogen known to cause cIAI.|||percentage of participants|||Number
2574853|NCT02475733|Secondary|Percentage of Participants With Favorable Clinical Response (CR): Clinically Evaluable (CE) Analysis Population|Favorable CR was resolution of all acute signs and symptoms of cIAI, or improvement to such an extent that no further antimicrobial therapy was required, or improvement in participants who had switch to oral therapy and met the following criterion: afebrile (temperature <=38.0°C) for at least 24 hours, absence of new and improvement in at least 1 symptom or sign (fever, pain, tenderness, elevated WBCs, elevated c-reative-protein) from baseline and worsening of none. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study (if on oral switch therapy). TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).|End of 72 hours study drug treatment on Day 1, EOIV (anytime from Day 4 up to 16), EOT visit (up to Day 17) and TOC visit (up to a maximum study duration of 50 days)|CE analysis population included randomized participants with cIAI who received study medication for >=48h and clinical failure or clinical failure with treatment limiting AE and participants with >=72h treatment and favorable clinicial response.|||percentage of participants||95% Confidence Interval|Number
2574854|NCT02475733|Secondary|Percentage of Participants With Favorable Clinical Response (CR) at Test of Cure (TOC) Visit: Intent-to-treat (ITT) Analysis Population|Favorable CR was resolution of all acute signs and symptoms of cIAI, or improvement to such an extent that no further antimicrobial therapy was required. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).|TOC visit (up to a maximum study duration of 50 days)|ITT analysis population included all participants who had been assigned a randomized treatment.|||percentage of participants||95% Confidence Interval|Number
2574855|NCT02475733|Secondary|Percentage of Participants With Favorable Clinical Response (CR) at End of Treatment (EOT) Visit: Intent-to-treat (ITT) Analysis Population|Favorable CR was resolution of all acute signs and symptoms of cIAI, or improvement to such an extent that no further antimicrobial therapy was required. EOT visit occurred within 48 hours after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study (if on oral switch therapy).|EOT visit (up to Day 17)|ITT analysis population included all participants who had been assigned a randomized treatment.|||percentage of participants||95% Confidence Interval|Number
2574856|NCT02475733|Secondary|Percentage of Participants With Favorable Clinical Response (CR) at End of Intravenous Therapy (EOIV) Visit: Intent-to-treat (ITT) Analysis Population|Favorable CR was resolution of all acute signs and symptoms of cIAI or improvement to such an extent that no further antimicrobial therapy was required, or improvement in participants who had switch to oral therapy and met the following criterion: afebrile (temperature <=38.0°C) for at least 24 hours, absence of new and improvement in at least 1 symptom or sign (fever, pain, tenderness, elevated WBCs, elevated c-reative-protein) from baseline and worsening of none. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|EOIV visit (anytime from Day 4 up to 16)|ITT analysis population included all participants who had been assigned a randomized treatment.|||percentage of participants||95% Confidence Interval|Number
2574857|NCT02475733|Secondary|Percentage of Participants With Favorable Clinical Response (CR) at End of 72 Hours Treatment: Intent-to-treat (ITT) Analysis Population|Favorable CR was defined as resolution of all acute signs and symptoms of complicated intra- abdominal infection (cIAIs), or improvement to such an extent that no further antimicrobial therapy was required, or improvement but not enough to switch to oral therapy and still on IV study drug at end of 72 hours and had met following criterion: absence of new signs and symptoms, improvement in at least 1 symptom/sign (fever, pain, tenderness, elevated White Blood Cells [WBCs], elevated c-reactive protein) from baseline and no worsening symptom/sign.|End of 72 hours study drug treatment on Day 1|ITT analysis population included all participants who had been assigned a randomized treatment.|||percentage of participants||95% Confidence Interval|Number
2574858|NCT02475733|Secondary|Plasma Concentrations of Ceftazidime and Avibactam||15, 30-90, 300-360 minutes post-dose on Day 3|PK analysis set included all randomized participants who received any amount of study medication and had at least 1 CAZ and/ or AVI plasma measurement available. This outcome measure was not planned to be analyzed for meropenem receiving cohorts, as pre-specified in protocol.|||nanogram per milliliter||Standard Deviation|Geometric Mean
2574859|NCT02475733|Primary|Percentage of Participants With Creatinine Clearance (CrCl) at Late Follow-up (LFU) Visit|CrCl is a measure of GMFR, an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).|LFU visit (up to a maximum study duration of 50 days)|Safety analysis set included all randomized participants who received any amount of IV study medication.|||percentage of participants|||Number
2574860|NCT02475733|Primary|Percentage of Participants With Creatinine Clearance (CrCl) at Test of Cure (TOC) Visit|CrCl is a measure of GMFR, an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).|TOC visit (up to a maximum study duration of 50 days)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||percentage of participants|||Number
2574861|NCT02475733|Primary|Percentage of Participants With Creatinine Clearance (CrCl) at End of Intravenous Therapy (EOIV) Visit|CrCl is a measure of GMFR, an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|EOIV visit (anytime from Day 4 up to 16)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||percentage of participants|||Number
2574862|NCT02475733|Primary|Percentage of Participants With Creatinine Clearance (CrCl) at Day 7|CrCl is a measure of glomerular filtration rate (GMFR), an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2.|Day 7|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||percentage of participants|||Number
2574863|NCT02475733|Primary|Percentage of Participants With Electrocardiogram (ECG) Parameter QTcF: > 450, >480 and >500 Millisecond (ms)|ECG parameters included maximum QT intervals using Fridericia's correction (QTcF). Maximum QTcF >450 millisecond (ms); maximum QTcF >480 ms; and maximum QTcF >500 ms. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline until the EOIV visit (anytime from Day 4 to 16)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||percentage of participants|||Number
2574864|NCT02475733|Primary|Percentage of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters|Criteria for potentially clinically significant laboratory abnormalities: Chemistry (calcium: <0.7*lower limit of normal range [LLN] and >30 percent decrease from baseline [DFB]; alanine aminotransferase [ALT]: >3*upper limit of normal range [ULN] and >300 percent IFB; alanine aminotransferase [AST]: >3*ULN and >300 percent IFB) and hematology (platelets: >2*ULN and >100 percent IFB). LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).|Baseline until the LFU visit (up to a maximum study duration of 50 days)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||percentage of participants|||Number
2574865|NCT02475733|Primary|Percentage of Participants With Abnormal Physical Examination Findings at End of Intravenous Therapy (EOIV) Visit|Physical examination included an assessment of the following: general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, thyroid, respiratory system, cardiovascular system, abdomen, musculoskeletal system (including spine and extremities), and neurological system. Participants with new or aggravated abnormal physical examination findings with regard to baseline findings were reported. Abnormality in physical examinations were based on blinded observer's discretion. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|EOIV visit (anytime from Day 4 up to 16)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||percentage of participants|||Number
2574866|NCT02475733|Primary|Change From Baseline in Body Temperature at End of Intravenous Therapy (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 up to 16)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||degree Celsius||Standard Deviation|Mean
2574867|NCT02475733|Primary|Change From Baseline in Body Weight at End of Intravenous Therapy (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 up to 16)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||kilograms||Standard Deviation|Mean
2574868|NCT02475733|Primary|Change From Baseline in Respiratory Rate at End of Intravenous Therapy (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 up to 16)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||breaths per minute||Standard Deviation|Mean
2574869|NCT02475733|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End of Intravenous Therapy (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 up to 16)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2574922|NCT02475629|Secondary|Mean Change in Viral Load as a Measure of Efficacy - ITT-MEF|Mean change from Day 7/Baseline in log 10 vial load measured at Day 14|Day 7 and Day 14|Intent to Treat (ITT) Population (all participants enrolled) with missing values set to zero change|||Log10 copies/mL||Standard Deviation|Mean
2574870|NCT02475733|Primary|Change From Baseline in Pulse Rate at End of Intravenous Therapy (EOIV) Visit|EOIV visit occurred within 24 hours after completion of last infusion of the study drug.|Baseline, EOIV visit (anytime from Day 4 up to 16)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||beats per minute||Standard Deviation|Mean
2574871|NCT02475733|Primary|Percentage of Participants With Cephalosporin Class Effects and Additional Adverse Events (AEs)|Percentage of participants with Cephalosporin class effects (defined as adverse event of special interest (AEoSI) within the safety topics (ST) of hypersensitivity/anaphylaxis) and additional AEs (which included AEs of seizures, diarrhea, renal disorder, and liver disorder relevant to the cephalosporin class within the ST and AEs with preferred term in the system organ class of nervous system disorder system organ class based on MedDRA 20.0) were reported in this outcome measure.|Baseline until the LFU visit (up to a maximum study duration of 50 days)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||percentage of participants|||Number
2574872|NCT02475733|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between first dose of study drug and up to late follow-up (LFU) visit (20 to 35 days after last dose of study treatment [IV or oral]) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE.|Baseline until the LFU visit (up to a maximum study duration of 50 days)|Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).|||percentage of participants|||Number
2574873|NCT02475655|Other Pre-specified|Level of HHV Shedding (EBV, HSV, HHV-6, HHV-7, and HHV-8)|Data not available because no samples were collected to test for these measures as the team decided they were no longer clinically relevant.|Pre-entry, Entry, Weeks 1, 2, 4, 5, 10, and 12|Results not reported.||||||
2574874|NCT02475655|Other Pre-specified|Change in HIV-1 Reservoir|"HIV-1 reservoir includes: 2 long-terminal repeat sequences [LTRs], and integrated DNA.~Data not available as of February, 2019. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript (e.g. IL-6 and sCD14)."|Entry, Week 5, and Week 12||2021-02-28|02/2021||||
2574875|NCT02475655|Secondary|Pharmacokinetics of Ruxolitinb|Pharmacokinetic data is not available as of February, 2019. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript (e.g. IL-6 and sCD14).|Week 1 and Week 4||2021-02-28|02/2021||||
2574876|NCT02475655|Secondary|Level of CMV Shedding|"Level of CMV shedding will be summarized by study week and arm as the frequency and percentage of those above and below the assay limit of detection. The proportion of participants with detectable CMV at any on-treatment time point (ever shedding at weeks 1, 2, 4, or 5) and any post-treatment time point (ever shedding at weeks 10 or 12) will be contrasted between study arms via using a two-sided mid-p Fisher's exact test with 10% type-I error.~CMV shedding data are not available as of February, 2019. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript (e.g. IL-6 and sCD14)."|Pre-entry, Entry, and Weeks 1, 2, 4, 5, 10, and 12||2021-02-28|02/2021||||
2574877|NCT02475655|Secondary|Change in Cellular HIV-1 DNA|Cellular HIV-1 DNA data are not available as of February, 2019 for soluble markers of immune activation and inflammation in the peripheral blood. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript (e.g. IL-6 and sCD14).|Entry, Weeks 5 and 12||2021-02-28|02/2021||||
2574878|NCT02475655|Secondary|Change in Cellular HIV-1 Total RNA|Cellular HIV-1 total RNA data are not available as of February, 2019. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript (e.g. IL-6 and sCD14).|Entry, Weeks 5 and 12||2021-02-28|02/2021||||
2574879|NCT02475655|Secondary|Relative Risks of HIV-1 RNA by Single Copy Assay (SCA) < 0.4 Copies/mL|HIV-1 RNA was measured via Single Copy Assay Using Primer in Integrase (iSCA), results were reported as below or above the assay limit of detection (LOD) (LOD = 0.4 copies/mL). GEE models for binary data were used to calculate the relative risk of having HIV-1 RNA by iSCA <0.4 copies/mL (Week 5 compared to Entry, Week 12 compared to Entry, and Week 12 compared to Week 5).|Entry, Weeks 5 and 12|As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization).|||Relative Risk||95% Confidence Interval|Mean
2574880|NCT02475655|Secondary|Change in CD4+ T Cell Count|Baseline is defined as the average of pre-entry and entry. Absolute change was calculated as the value at Week 2 minus the value at Baseline, the value at week 5 minus the value at baseline, the value at week 12 minus the value at baseline, and the value at week 5 minus the value at week 12.|Pre-entry, Entry, Weeks 2, 5, and 12|As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization).|||cells/mm^3||95% Confidence Interval|Mean
2574923|NCT02475629|Secondary|Efficacy: Proportion of Patients With Undetectable HIV-RNA Levels: Protocol Correct|Proportion of patients (%) with HIV-RNA levels < 50 copies/mL and < 400 copies/mL at Week 25/End of Study|Week 25/End of Study|Protocol Correct (PC) Population (all participants with non-missing viral load assessments at Day 7, Day 14 and Week 25/End of Study)|||proportion of participants||95% Confidence Interval|Number
2574881|NCT02475655|Secondary|Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification|Participants were required to be virally suppressed, with a plasma HIV-1 RNA level below 40 copies/mL. The number of participants with plasma HIV-1 RNA level above the limit of quantification is reported at each time point.|Entry, Weeks 2, 5, and 12|Analysis was done in the safety analysis population for participants with available data. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||Participants|||Count of Participants
2574882|NCT02475655|Secondary|Change in Cellular Markers of Immune Activation and Inflammation in the Peripheral Blood|"Cellular markers of immune activation and inflammation in the peripheral blood include: HLA-DR, CD25, CD38, CD69, CD127, Ki67, BCL2, a4b7, CX3CR1, PAR-1 measured on CD4 and CD8 cells; monocyte subsets (classical, inflammatory, and patrolling) expressing CCR2, CX3CR1, and CD163.~Data are not available as of February, 2019 for cellular markers of immune activation and inflammation in the peripheral blood. These data are based on assays which are to be tested in batch to minimize variability. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript (e.g. IL-6 and sCD14)."|Entry, Week 5, and Week 12||2021-02-28|02/2021||||
2574883|NCT02475655|Secondary|Change in Soluble Markers of Immune Activation and Inflammation in the Peripheral Blood|"Soluble markers of immune activation and inflammation in the peripheral blood include: TNF-α, IL-1α, IL-1β, IL-7, IL-10, IP-10, IL-18, mCSF, and neopterin.~Data are not available as of April, 2019 for soluble markers of immune activation and inflammation in the peripheral blood. Please note that these secondary outcomes were not included in the primary analysis report. There are many outcomes in this study and the labs had to give priority to the assays planned to be included in the primary manuscript (e.g. IL-6 and sCD14)."|Pre-entry, Entry, Weeks 4, 5, and 12||2021-02-28|02/2021||||
2574884|NCT02475655|Secondary|Fold Change in the Level of Soluble CD14 (sCD14)|"All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.~Baseline is defined as the geometric mean of the Pre-entry and Entry values. Week 4/5 is defined as the geometric mean of the Week 4 and Week 5 values. Fold change was calculated as the value at Week 4/5 divided by the value at Baseline, the value at Week 12 divided by the value at Baseline, and the value at Week 12 divided by the value at Week 4/5."|Pre-entry, Entry, Weeks 4, 5, and 12|As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization).|||Fold Change||95% Confidence Interval|Geometric Mean
2574885|NCT02475655|Secondary|Fold Change in the Level of Plasma Interleukin 6 (IL-6)|"All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.~Baseline is defined as the geometric mean of the Pre-entry and Entry values. Week 4/5 is defined as the geometric mean of the Week 4 and Week 5 values. Week 10/12 is defined as the geometric mean of the Week 10 and Week 12 values. Fold change was calculated as the value at Week 10/12 divided by the value at Baseline and the value at Week 4/5 divided by the value at Week 10/12."|Pre-entry, Entry, Weeks 4, 5, 10 and 12|As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization).|||Fold Change||95% Confidence Interval|Geometric Mean
2574886|NCT02475655|Secondary|Change in Alanine Aminotransferase (ALT) (SGPT) Values From Entry|"The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.~Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry."|Entry, Weeks 1, 2, 4, 5, 10, and 12|Analysis was done in the safety analysis population for participants with results available at entry and at the follow-up time point. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||U/L||95% Confidence Interval|Mean
2574887|NCT02475655|Secondary|Alanine Aminotransferase (ALT) (SGPT)|The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.|Entry, Weeks 1, 2, 4, 5, 10, and 12|Analysis was done in the safety analysis population for participants with available data. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||U/L||95% Confidence Interval|Mean
2574888|NCT02475655|Secondary|Change in Aspartate Aminotransferase (AST) (SGOT) Values From Entry|"The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.~Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry."|Entry, Weeks 1, 2, 4, 5, 10, and 12|Analysis was done in the safety analysis population for participants with results available at entry and at the follow-up time point. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||U/L||95% Confidence Interval|Mean
2574889|NCT02475655|Secondary|Aspartate Aminotransferase (AST) (SGOT)|The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.|Entry, Weeks 1, 2, 4, 5, 10, and 12|Analysis was done in the safety analysis population for participants with available data. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||U/L||95% Confidence Interval|Mean
2574924|NCT02475629|Secondary|Efficacy: Proportion of Patients With Undetectable Viral Load: ITT-MEF|Proportion of patients with undetectable Viral Load (<50 copies/mL, and <400 copies/mL)|Week 25 /end of study|Intent to Treat (ITT) Population (all participants enrolled) with missing values set to failure|||proportion of participants||95% Confidence Interval|Number
2574890|NCT02475655|Secondary|Change in Platelet Counts From Entry|"The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.~Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry."|Entry, Weeks 1, 2, 4, 5, 10, and 12|Analysis was done in the safety analysis population for participants with results available at entry and at the follow-up time point. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||Platelets/mm^3||95% Confidence Interval|Mean
2574891|NCT02475655|Secondary|Platelet Count|The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.|Entry, Weeks 1, 2, 4, 5, 10, and 12|Analysis was done in the safety analysis population for participants with available data. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||Platelets/mm^3||95% Confidence Interval|Mean
2574892|NCT02475655|Secondary|Change in Hemoglobin Values From Entry|"The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.~Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry."|Entry, Weeks 1, 2, 4, 5, 10, and 12|Analysis was done in the safety analysis population for participants with results available at entry and at the follow-up time point. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||g/dL||95% Confidence Interval|Mean
2574893|NCT02475655|Secondary|Hemoglobin|The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.|Entry, Weeks 1, 2, 4, 5, 10, and 12|Analysis was done in the safety analysis population for participants with available data. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||g/dL||95% Confidence Interval|Mean
2574894|NCT02475655|Secondary|Change in Absolute Neutrophil Count (ANC) Values From Entry|"The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.~Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry."|Entry, Weeks 1, 2, 4, 5, 10, and 12|Analysis was done in the safety analysis population for participants with results available at entry and at the follow-up time point. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||cells/mm^3||95% Confidence Interval|Mean
2574895|NCT02475655|Secondary|Absolute Neutrophil Count (ANC)|The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.|Entry, Weeks 1, 2, 4, 5, 10, and 12|Analysis was done in the safety analysis population for participants with available data. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||cells/mm^3||95% Confidence Interval|Mean
2574896|NCT02475655|Secondary|Change in Creatinine Values From Entry|"The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.~Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry."|Entry, Weeks 1, 2, 4, 5, 10, and 12|Analysis was done in the safety analysis population for participants with results available at entry and at the follow-up time point. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||mL/min||95% Confidence Interval|Mean
2574897|NCT02475655|Secondary|Creatinine|The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.|Entry, Weeks 1, 2, 4, 5, 10, and 12|Analysis was done in the safety analysis population for participants with available data. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||mg/dL||95% Confidence Interval|Mean
2574898|NCT02475655|Secondary|Change in Creatinine Clearance Values From Entry|"Creatinine clearance was calculated using the Cockcroft Gault equation. The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.~Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry."|Entry, Weeks 1, 2, 4, 5, 10, and 12|Analysis was done in the safety analysis population for participants with results available at entry and at the follow-up time point. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||mL/min||95% Confidence Interval|Mean
2574899|NCT02475655|Secondary|Creatinine Clearance|Creatinine clearance was calculated using the Cockcroft Gault equation. The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.|Entry, Weeks 1, 2, 4, 5, 10, and 12|Analysis was done in the safety analysis population for participants with available data. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||mL/min||95% Confidence Interval|Mean
2574925|NCT02475629|Primary|Efficacy: Proportion of Subjects With a Viral Load Decrease of at Least 0.5 Log 10 - Protocol Correct|Proportion of patients (%) with a viral load decrease of at least 0.5 log 10 from baseline (day 7)|Day 14|Protocol Correct (PC) Population (all participants with non-missing viral load assessments at Day 7, Day 14 and Week 25/End of Study)|||proportion of participants||95% Confidence Interval|Number
2574900|NCT02475655|Secondary|Number of Participants Who Experienced a Protocol-defined Reportable Adverse Event at Any Post-entry Time Point.|"Protocol-defined reportable adverse events include: all diagnoses regardless of grade, Grade 3 or higher sign/symptoms or laboratory values, any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. See the Protocol Section References for links to the EAE manual.~This is a subset of the events reported in the Adverse Events section."|Entry to Week 12|Analysis was done in the safety analysis population. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||Participants|||Count of Participants
2574901|NCT02475655|Secondary|Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12|"Events defined as safety milestones are listed below.~Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm3 (for participants with entry CD4+ T cell count < 700 cells/mm3)~Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm3)~Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART~New or recurrent CDC category C AIDS-indicator condition~HIV-1 associated infection including Herpes zoster~Lymphoproliferative malignancies~Grade 4 or recurrence of Grade 3 anemia/neutropenia~New diagnosis of pneumonia, sepsis, or bacteremia~Occurrence of Grade 2 or higher thrombocytopenia~Any Grade 4 or recurrence of Grade 3 toxicity~Percent experiencing each safety milestone will be reported. Safety milestone categories are not mutually exclusive."|Entry to Week 12|Analysis was done in the safety analysis population. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||percentage of participants|||Number
2574902|NCT02475655|Secondary|Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 12|"Events defined as safety milestones are listed below and together makeup the composite endpoint.~Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)~Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)~Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART~New or recurrent CDC category C AIDS-indicator condition~HIV-1 associated infection including Herpes zoster~Lymphoproliferative malignancies~Grade 4 or recurrence of Grade 3 anemia/neutropenia~New diagnosis of pneumonia, sepsis, or bacteremia~Occurrence of Grade 2 or higher thrombocytopenia~Any Grade 4 or recurrence of Grade 3 toxicity~Percent experiencing a safety milestone will be reported."|Entry to Week 12|Analysis was done in the safety analysis population. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||percentage of participants|||Number
2574903|NCT02475655|Secondary|Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events During Total Follow-up|"Events defined as safety milestones are listed below and together makeup the composite endpoint.~Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)~Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)~Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART~New or recurrent CDC category C AIDS-indicator condition~HIV-1 associated infection including Herpes zoster~Lymphoproliferative malignancies~Grade 4 or recurrence of Grade 3 anemia/neutropenia~New diagnosis of pneumonia, sepsis, or bacteremia~Discontinuation of Ruxolitinib due to thrombocytopenia~Any Grade 4 or recurrence of Grade 3 toxicity related to study drug~Percent experiencing a safety milestone will be reported."|Entry to Week 12|Analysis was done on participants on the Ruxolitinib arm in the safety analysis population. These were all participants randomized to the Ruxolitinib arm who took at least one dose of Ruxolitinib.|||percentage of participants|||Number
2574904|NCT02475655|Primary|Fold Change in the Level of Plasma Interleukin 6 (IL-6) From Baseline to Week 4/5|"All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation.~Baseline is defined as the geometric mean of the Pre-entry and Entry values. Week 4/5 is defined as the geometric mean of the Week 4 and Week 5 values. Fold change was calculated as the value at Week 4/5 divided by the value at Baseline."|Pre-entry, Entry, Weeks 4 and 5|Analysis was done in the as-treated population (had data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization).|||Fold Change||95% Confidence Interval|Geometric Mean
2574905|NCT02475655|Primary|Number of Participants With Premature Discontinuation of Study Treatment in the Ruxolitinib Arm|Number of participants with premature discontinuation of study treatment are summarized.|Entry to Week 5|All participants on the Ruxolitinib arm are included.|||Participants|||Count of Participants
2574906|NCT02475655|Primary|Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5|"Events defined as safety milestones are listed below.~Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)~Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)~Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART~New or recurrent CDC category C AIDS-indicator condition~HIV-1 associated infection including Herpes zoster~Lymphoproliferative malignancies~Grade 4 or recurrence of Grade 3 anemia/neutropenia~New diagnosis of pneumonia, sepsis, or bacteremia~Occurrence of Grade 2 or higher thrombocytopenia~Any Grade 4 or recurrence of Grade 3 toxicity~Percent experiencing each safety milestone will be reported. Safety milestone categories are not mutually exclusive."|Entry to Week 5|Analysis was done in the safety population. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||percentage of participants|||Number
2574926|NCT02475629|Primary|Efficacy: Proportion of Participants Achieving a Viral Load Reduction of at Least 0.5 Log 10: ITT-MEF|Proportion of participants (%) achieving a viral load reduction of at least 0.5 log from baseline (Day 7)|Day 14|Intent to Treat (ITT) Population (all participants enrolled) with missing values set to zero change|||proportion of participants||95% Confidence Interval|Number
2574907|NCT02475655|Primary|Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 5|"Events defined as safety milestones are listed below and together makeup the composite endpoint.~Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)~Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)~Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART~New or recurrent CDC category C AIDS-indicator condition~HIV-1 associated infection including Herpes zoster~Lymphoproliferative malignancies~Grade 4 or recurrence of Grade 3 anemia/neutropenia~New diagnosis of pneumonia, sepsis, or bacteremia~Occurrence of Grade 2 or higher thrombocytopenia~Any Grade 4 or recurrence of Grade 3 toxicity~Percent experiencing a safety milestone will be reported."|Entry to Week 5|Analysis was done in the safety analysis population. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm.|||percentage of participants|||Number
2574908|NCT02475655|Primary|Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events While On-Treatment|"Events defined as safety milestones are listed below and together makeup the composite endpoint.~Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)~Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)~Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART~New or recurrent CDC category C AIDS-indicator condition~HIV-1 associated infection including Herpes zoster~Lymphoproliferative malignancies~Grade 4 or recurrence of Grade 3 anemia/neutropenia~New diagnosis of pneumonia, sepsis, or bacteremia~Discontinuation of Ruxolitinib due to thrombocytopenia~Any Grade 4 or recurrence of Grade 3 toxicity related to study drug~Percent experiencing a safety milestone will be reported."|Entry to Week 5|Analysis was done on participants on the Ruxolitinib arm in the safety analysis population. These were all participants randomized to the Ruxolitinib arm who took at least one dose of Ruxolitinib.|||percentage of participants|||Number
2574909|NCT02475629|Other Pre-specified|Pharmacodynamics: CD4 Receptor Occupancy|% of CD receptors occupied by ibalizumab on CD4+ T-cells|At Week 25/End of Study|Intent to Treat (ITT) Population (all participants enrolled) with non-missing receptor occupancy assessments|||percentage of receptors||Standard Deviation|Mean
2574910|NCT02475629|Secondary|Proportion of Participants Experiencing New AIDS-defining Adverse Event According to CDC Criteria as a Measure of Safety and Tolerability|Proportion of participants experiencing treatment emergent adverse event that is AIDS-defining by the CDC adverse event classification criteria for HIV infection|Through Week 25/End of Study|All participants receiving at least one partial dose of study drug|||Participants|||Count of Participants
2574911|NCT02475629|Secondary|Proportion of Participants Experiencing Adverse Event With Death as Outcome as a Measure of Safety and Tolerability|Proportion of participants experiencing treatment emergent adverse event with death as the outcome, regardless of relationship to study drug|Through Week 25/End of Study|All participants receiving at least one partial dose of study drug|||Participants|||Count of Participants
2574912|NCT02475629|Secondary|Proportion of Participants Experiencing Adverse Event Grade 3 and Higher as a Measure of Safety and Tolerability|Proportion of participants experiencing treatment emergent adverse event Grade 3 and higher|Through Week 25/End of Study|All participants receiving at least one partial dose of study drug|||Participants|||Count of Participants
2574913|NCT02475629|Secondary|Proportion of Participants Discontinuing Study Drug Due to Adverse Event|Proportion of participants discontinuing study drug due to occurrence of treatment emergent adverse event|Through Week 25/End of Study|All participants receiving at least one partial dose of study drug|||Participants|||Count of Participants
2574914|NCT02475629|Secondary|Proportion of Participants Experiencing Serious Adverse Event as a Measure of Safety and Tolerability|Proportion of participants experiencing at least one serious treatment emergent adverse event, excluding death|Through Week 25/End of Study|All participants receiving at least one partial dose of study drug|||Participants|||Count of Participants
2574915|NCT02475629|Secondary|Proportion of Participants Experiencing Adverse Event Related to Study Drug as a Measure of Safety and Tolerability|Proportion of participants experiencing a treatment emergent adverse event determined by the investigator to be related to study drug|Through Week 25/End of Study|All participants receiving at least one partial dose of study drug|||Participants|||Count of Participants
2574916|NCT02475629|Secondary|Safety: Proportion of Participants Experiencing Adverse Events|Proportion of participants experiencing at least one treatment emergent adverse event to week 25/End of Study|Through Week 25/End of Study|All participants receiving at least one partial dose of study drug|||Participants|||Count of Participants
2574917|NCT02475629|Secondary|Mean Change in CD4+ Cell Count as a Measure of Efficacy and Safety - Protocol Correct|Mean change from Day 7/Baseline in CD4+ cell count at Week 25/End of Study|Day 7 and Week 25/End of Study|Protocol Correct (PC) Population (all participants with non-missing viral load assessments at Day 7, Day 14 and Week 25/End of Study) with non-missing CD4+ cell count measurements|||cells/mm^3||Standard Deviation|Mean
2574918|NCT02475629|Secondary|Mean Change in CD4+ Cell Count as a Measure of Efficacy and Safety - ITT|Mean change from Day 7/Baseline in CD4+ cell count at Week 25/End of Study|Day 7 and Week 25/End of Study|Intent to Treat (ITT) Population (all participants enrolled). Only obtained values were included in analysis - missing values were not imputed.|||cells/mm^3||Standard Deviation|Mean
2574919|NCT02475629|Secondary|End of Study Viral Load Reductions as a Measure of Efficacy - Protocol Correct Analysis|Proportion of patients achieving a >/= 0.5 log10 and >/= 1.0 log10 decrease from Day 7/Baseline in viral load at Week 25/End of Study|at Week 25/End of Study|Protocol Correct (PC) Population (all participants with non-missing viral load assessments at Day 7, Day 14 and Week 25/End of Study)|||proportion of participants||95% Confidence Interval|Number
2574920|NCT02475629|Secondary|End of Study Viral Load Reductions as a Measure of Efficacy - Intent to Treat Analysis|Proportion of patients achieving a >/= 0.5 log10 and >/= 1.0 log10 decrease from Day 7/Baseline in viral load at Week 25/End of Study|at Week 25/End of Study|Intent to Treat (ITT) Population (all participants enrolled) with missing values set to zero change|||proportion of participants||95% Confidence Interval|Number
2574927|NCT02475564|Secondary|Serum Prolactin Levels at 42 Days|Serum levels of prolactin will be measured after 42 days of treatment. Median levels of prolactin were compared between both groups on day 42.|42 days|one of the subjects in the placebo group decided to leave the study after randomization, thus n = 21|||ng/mL||Full Range|Median
2574928|NCT02475564|Secondary|Serum CA125 Levels at 42 Days|Serum levels of CA125 will be measured after 42 days of treatment in UI/mL. Median levels of CA125 were compared between both groups on day 42, and to baseline values (day 1).|42 days|One of subjects from the placebo group decided to leave the study after randomization, thus the n = 21 in the CA125 levels.|||UI/mL||Full Range|Median
2574929|NCT02475564|Primary|Pain Scores Measured by VAS (Visual Analog Scale) at Day 42.|Pain will be measured by VAS (visual analog scale) as baseline and at the end of the study, considering the last 7 days. VAS was used to measuring pain intensity, ranging continuously from 0 (no pain) to 10 (worst imaginable pain). The main outcome compared median pain levels between both arms on day 42.|42 days|Intention to treat analysis, patients who were lost on follow-up had their last registry on pain values or plasma levels measurements repeated in the following consultations.|||units on a scale||Full Range|Median
2574930|NCT02475395|Secondary|Number of Accurate and Inaccurate Results Obtained by Healthcare Professionals Performing Trak Assays on Subjects' Samples.|Healthcare professions obtained a categorical sperm concentration result by performing assay on aliquot obtained from Lay User's sample. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Reference result using gold standard (CASA) was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match reference category result.|Participants will be followed for one visit for up to 2 hours|One fewer was analyzed in this population because a sample did not have enough sample to allow the HCP to run the test.|||Participants|||Count of Participants
2574931|NCT02475395|Secondary|Number of Accurate and Inaccurate Subfertility Results as Obtained by Healthcare Professionals Observing Assays Result Performed by Untrained Lay Users.|Healthcare professions obtained a categorical sperm concentration result by observing completed assay outputs as performed by Lay Users. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Reference result using gold standard (CASA) was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match reference category result.|Participants will be followed for one visit for up to 2 hours||||Participants|||Count of Participants
2574932|NCT02475395|Primary|Number of Untrained Lay Users That Obtained Accurate and Inaccurate Subfertility Results From the TRAK Device When Compared to Results Obtained From the Gold Standard|Lay users obtained categorical sperm concentration result. Positive (for subfertility) results are less than or equal to 15 M/mL threshold. Gold standard reference (analysis by Computer-aided Semen Analysis [CASA]) result was measured and compared to Trak. True positive and true negative matched Reference category result and false negative, false positive did not match gold standard reference category result.|Participants will be followed for one visit for up to 2 hours||||Participants|||Count of Participants
2574933|NCT02475278|Primary|Number of Participants With Serum Samples Obtained on Day 29 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies|Serum samples were obtained to establish proficiency panels for the pan-Ig ELISA and the HBGA binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 29 are reported.|Day 29|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).|||participants|||Number
2574934|NCT02475278|Secondary|Percentage of Participants Experiencing Serious Adverse Events|A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|Day 1 up to Day 183|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).|||percentage of participants|||Number
2574935|NCT02475278|Secondary|Percentage of Participants With Unsolicited Adverse Events (AEs) by Maximum Severity|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study. Unsolicited AEs are presented as the percentage of participants experiencing at least one AE, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.|Days 1 through 28|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).|||percentage of participants|||Number
2574936|NCT02475278|Secondary|Percentage of Participants With Elevated Daily Oral Temperature|Safety assessment included measurement of body temperature for 7 days following vaccination (including the day of vaccination) by using diary cards. Participants recorded the highest body temperature observed each day in a daily diary. The highest body temperature measurement per participant across Day 1 to Day 7 was categorized as fever present (≥100.4ºF, ≥38ºC) or fever absent (<100.4ºF, <38ºC).|Days 1 to 7 days after vaccination|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).|||percentage of participants|||Number
2574937|NCT02475278|Secondary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Maximum Severity|Safety assessment included collection of solicited systemic AEs for 7 days following vaccination (including the day of vaccination) by using diary cards. Solicited systemic AEs are defined as headache, fatigue, myalgia, arthralgia, vomiting and diarrhea and are summarized as either none or any, where 'any' will be broken down into the following severity categories: mild, moderate, severe. Solicited systemic AEs are presented as the percentage of participants experiencing a solicited systemic AE, by AE, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.|Days 1 through 7|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).|||percentage of participants|||Number
2574938|NCT02475278|Secondary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Maximum Severity|Safety assessment included collection of solicited local AEs for 7 days following vaccination (including the day of vaccination) by using diary cards. Solicited local injection site AEs are defined as pain, erythema (redness), induration and swelling. Pain is summarized as either none or any, where 'any' will be broken down into the following severity categories: mild, moderate, severe. Erythema, swelling and induration are recorded as yes or no, where the definition of 'yes' is any area ≥2.5 cm; and 'yes' is further broken down into the following severity categories: ≥2.5 cm - ≤5.0 cm (mild intensity), >5.0 cm - ≤ 10.0 cm (moderate intensity), >10.0 cm severe intensity). Injection site AEs are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.|Days 1 through 7|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).|||percentage of participants|||Number
2574939|NCT02475278|Primary|Number of Participants With Serum Samples Obtained on Day 15 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies|Serum samples were obtained to establish proficiency panels for the pan-Ig ELISA and the HBGA binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 15 are reported.|Day 15|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).|||participants|||Number
2574940|NCT02475278|Primary|Number of Participants With Serum Samples Obtained on Day 8 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies|Serum samples were obtained for assay validation of the pan-Ig enzyme-linked immuno-sorbent assay (ELISA) and the histoblood group antigen (HBGA) binding assay. The number of participants with assessments for both the GI.1 VLP and GII.4 VLP antibodies and by both the pan-Ig ELISA and the HBGA binding assay, and with values available at Baseline and Day 8 are reported.|Day 8|Safety Analysis Set, all participants who received the trial vaccine (NoV Vaccine).|||participants|||Number
2574941|NCT02475265|Primary|Percent Change in Bone Mineral Density (BMD) of Lumbar Spine by Dual Energy X-ray Absorptiometry (DXA)|Percent change in lumbar spine bone mineral density after six-months. Lumbar spine bone mineral density measured by dual energy x-ray absorptiometry.|6 months||||percent change||Standard Error|Mean
2574942|NCT02475070|Secondary|Incretin Hormones|Area under the curve (AUC) of the 180 min glucagon like peptide-1 levels after mixed meal (0, 5, 10, 15, 30, 45, 60, 75, 90, 120, 150, 180 and 240 minutes post-dose)|240min||||nmol/l min||Standard Error|Mean
2574943|NCT02475070|Primary|Glucagon Response to Meal|Area under the curve (AUC) of the 180 min glucagon levels after mixed meal ingestion (0, 5, 10, 15, 30, 45, 60, 75, 90, 120, 150,180 and 240 minutes post-dose)|240 min||||nmol/l min||Standard Error|Mean
2574944|NCT02475031|Secondary|Sedation Scores at 48 Hours|Post-operative sedation scores will be recorded at 48 hours. Range of score is 0-3. 0=Awake and Alert, 1=Quietly Awake, 2=Asleep and Arousable, 3=Deep sleep.|48 hours||||units on a scale||Standard Error|Mean
2574945|NCT02475031|Secondary|Nausea Scores at 48 Hours|Post-operative nausea scores will be recorded at 48 hours. Range of nausea score is 0-3. 0= None, 1=Mild, 2=Moderate, 3=Severe.|up to 48 hours||||units on a scale||Standard Error|Mean
2574946|NCT02475031|Secondary|Average Pain Scores|Post- operative VAS pain scores (range of 0-10. 0 being no pain and 10 being worst pain) will be recorded at 1,12, 24, 36,48 and 60 hours. The values at each time points were combined and averaged.|up to 60 hours||||units on a scale||Standard Error|Mean
2574947|NCT02475031|Secondary|Secondary Endpoints Measured Will be Total Narcotic Usage at 60 Hours|All narcotic usage will be recorded at 1,12,24,36,48, and 60 hours. All narcotics will be converted to morphine equivalent for statistical calculation. These values reflect the total amount of narcotic used after combining all the data collected from each time point.|up to 60 hours||||mg||Standard Error|Mean
2574948|NCT02475031|Primary|Total Narcotic Usage at 48 Hours|The primary endpoint of this study will be narcotic requirement at 48 hours|48 hours||||mg||Standard Error|Mean
2574949|NCT02474901|Other Pre-specified|Number of Participants With PCR-diagnosed Influenza and Clinically-diagnosed Influenza Like Illness.|Compare numbers of participants with influenza diagnosed by PCR and with clinically-diagnosed influenza between the two groups. Data was taken from Influenza Infection Questionnaires #1 and #2. The last questionnaire (#2) was administered between May 15 and June 10, 2014 (after the vaccine). Data is reported as PCR-confirmed influenza and clinically-diagnosed influenza (subject told had influenza without confirmatory testing).|up to 11 months post-vaccination|Number of participants analyzed reflects the number of subjects who participated in the end-of-season interview.|||Participants|||Count of Participants
2574950|NCT02474901|Secondary|Number of Participants Reaching Seroprotection (HAI ≥ 40) Within the HIV-positive and Control Groups.|The investigators will measure hemagglutinin inhibition (HAI) on blood samples #2 (14-21 days after vaccination) for all participants. The investigators will also compare the number of participants reaching HAI ≥ 40 for each virus sub-type contained in the vaccine.|14-21 days|The total number of participants analyzed reflect the number of subjects for whom there was a blood sample from the 4th visit at day 14-21.|||Participants|||Count of Participants
2574951|NCT02474901|Secondary|Number of Participants With Adverse Events Within 14 Days After Vaccination|The investigators will compare the number of adverse events (AE) reported by AE category within 14 days after vaccination as reported by each participant. Data will reflect whether a participant ever reported the AE, and not the number of times the AE was reported.|14 days after vaccination for AEs; up to 30 days for unscheduled visits||||Participants|||Count of Participants
2574952|NCT02474901|Primary|Number of Participants With Shedding for at Least One of the Influenza Strains Included in the QLAIV Vaccine at Each of the 4 Study Visits, Days 0 (Baseline), 2-5, 7-10, and 14-21 in HIV-positive and Control Groups.|Measure PCR positivity for any of the influenza subtypes included in QLAIV at visit 1 (day 0), visit 2 (days 2-5), visit 3 (days 7-10) and visit 4 (days 14-21). Compare number of participants with shedding for any subtype in each patient group. (The study was powered based on the 7-10 day data.)|day 0-21 post-vaccine|Subjects with data for any of the visits|||Participants|||Count of Participants
2574953|NCT02474901|Primary|Number of Participants With Shedding for at Least One of the Influenza Strains Included in the QLAIV in the First 21 Days After Vaccine Administration Days in HIV-positive and Control Groups.|Measure PCR positivity for any of the influenza subtypes included in QLAIV between baseline (day 0) and the last study visit at 14-21 days after vaccine. Compare number of participants with PCR positivity for any of the vaccine-strain influenza virus strains in each patient group.|21 days|HIV-infected and uninfected recipients of QLAIV; one HIV-uninfected subject was lost-to-follow-up after the first follow-up visit following vaccination.|||Participants|||Count of Participants
2574954|NCT02474589|Primary|To Determine the Number of Participants With Adverse Events|To determine the safety and tolerability of oral tecovirimat|45 days||||Participants|||Count of Participants
2574955|NCT02474498|Secondary|Relative Gingival Margin Position (RGMP) at 12 Months||12 months||||mm||Standard Deviation|Mean
2574956|NCT02474498|Secondary|Periodontal Probing Depth at 12 Months||12 months||||mm||Standard Deviation|Mean
2574957|NCT02474498|Secondary|Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months|The relative vertical clinical attachment level (RVCAL) will be measured with the same type of probe (PCP-15 Periodontal Probe - Hu-Friedy - Chicago, IL, USA) as the distance between the deepest point reached by the probe when introduced vertically into the buccal periodontal pocket. This parameter will be evaluated at one specific site at the buccal furcation entrance, determined by a groove made on an individually manufactured acrylic stent and recorded to the nearest 0.5mm.|12 months||||mm||Standard Deviation|Mean
2574958|NCT02474498|Primary|Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months|The relative horizontal clinical attachment level (RHCAL) will be measured with the same type of probe (PCP-15 Periodontal Probe - Hu-Friedy - Chicago, IL, USA) as the distance between the deepest point reached by the probe when introduced horizontally into the furcation and the lower border of the stent. This parameter will be evaluated at one specific site at the buccal furcation entrance, determined by a groove made on an individually manufactured acrylic stent and recorded to the nearest 0.5mm.|12 months||||mm||Standard Deviation|Mean
2574959|NCT02474407|Secondary|Taste Change Questionnaire|Questionnaire given to safety population in Cohort 1 for reporting taste change during the study. If the subject spontaneously reports an experience of taste change associated with diazepam nasal spray dosing, it will be evaluated qualitatively by the research staff using a taste change questionnaire. The subject will be asked to describe the type, intensity, and duration of the change in taste at multiple scheduled time points after dosing. Between the 12 and 24 h time points, the questionnaire should be repeated every 4 hours as needed to follow any residual symptoms to resolution, and time of resolution should be documented.|Up to 24 hours|Safety Population / Cohort 1. (Accessed only for DZNS Arm)|||units on a scale||Standard Deviation|Mean
2574960|NCT02474407|Secondary|Smell Identification Test (SIT)|"The SIT is a validated test of smell identification which scores patients into different levels of olfactory function normalized by age and gender, however it had not been validated for use in PWE. The Smell Identification Test (SIT) is a 40-item multiple-choice standardized test. The test can be self-administered and consists of four 10-page booklets with a different scratch and sniff strip on each page. A scratch with a pencil releases the scent from the strip, and the subject is then asked to match the scent to one of four choices on the page. An answer must be selected for each of the 40 items, even when the subject cannot detect a smell. The total score (i.e., number of correct answers, range: 0-40) can be compared against normative data collected from approximately 4000 normal individuals between ages 4 to 99 to determine the subject's percentile rank of olfactory dysfunction corrected for age and gender."|day 1 up to day 31|Safety Population / Cohort 1. (Accessed only for DZNS Arm)|||Participants|||Count of Participants
2574961|NCT02474407|Secondary|Focused Nasal Exam (Part B)|"A focused nasal exam was completed by the Investigator in the treatment period(s) when diazepam nasal spray was administered, based on a visual inspection of the nasal mucosa. Focused Nasal Examination Part B - will show nasal mucosal symptoms that will be rated for severity will include discharge, mucosal edema, crusting, erythema, and epistaxis. This exam may be conducted within a 5 minute window after the specified time point. Between the 12 and 24 h time points, the exam was should be repeated every 4 hours as needed to follow any residual symptoms to resolution and the time of resolution should be documented.~(Categories with no data were omitted)"|pre-dose (day 1) up to 24 hours post-dose|The Safety population / Cohort 1. (Accessed only for DZNS Arm)|||Participants|||Count of Participants
2574962|NCT02474407|Secondary|Focused Nasal Exam (Part A)|"A focused nasal exam was completed by the Investigator in the treatment period(s) when diazepam nasal spray was administered, based on a visual inspection of the nasal mucosa. Nasal irritation will be graded none to Grade 4 septal perforation. Grade 1a= focal irritation, Grade 1b= superficial mucosal erosion, Grade 2= moderate mucosal erosion, Grade 3= ulceration, Grade 4= septal perforation. This exam may be conducted within a 5 minute window after the specified time point. Between the 12 and 24 h time points, the exam should be repeated every 4 hours as needed to follow any residual symptoms to resolution and the time of resolution should be documented.~(Categories with no data were omitted)"|pre-dose (day 1) up to 24 hours post-dose|Safety population Cohort 1. (Accessed only for DZNS Arm)|||Participants|||Count of Participants
2574963|NCT02474407|Primary|Cmax|Relative bioavailability based on maximum observed plasma concentration.|24 hours||||ng/mL||Standard Deviation|Mean
2574964|NCT02474407|Primary|AUC 0-24h|Relative bioavailability based on area under time plasma concentration curve.|24 hours||||ng*h/mL||Standard Deviation|Mean
2574965|NCT02474082|Secondary|Percentage of Participants With Short Form 36 (SF-36) Response at Week 4, 16 and 24|"SF-36 is a generic indicator of health status for use in population surveys and evaluative studies of health policy. The SF-36 included 36 items in a Likert-type or forced-choice format measured on eight dimensions. The scores for each domain range from 0 to 100, with high scores indicating a better status. SF-36 responder is defined as subject reaching at least an improvement of minimum important difference (MID). The SF-36 measure dimensions and their MID includes:~Physical Functioning:4.3~Role-Physical: 3.4~Bodily Pain: 6.2~General Health: 7.2~Vitality: 6.2~Social Functioning: 6.9~Role-Emotional: 4.5~Mental Health: 6.2~Two component scores and their MID which were derived from the above mentioned 8 domains includes-:~Physical component summary: 3.4~Mental component summary: 4.6"|Week 4, 16 and 24|The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for SF-36 response at week 4, 16 and 24|||Percentage of participants|||Number
2574966|NCT02474082|Secondary|Percentage of Participants With DLQI 0/1 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|"DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral. The measure was self-administered and included domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. Each item had four response categories ranging from 0 (not at all) to 3 (very much). Not relevant was also a valid response and was scored as 0. The DLQI total score was a sum of the 10 questions. Scores ranged from 0 to 30, with higher scores indicating greater impairment in health related quality of life. DLQI 0/1 response was the achievement of a DLQI score of 0 or 1."|Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population.|||Percentage of participants|||Number
2574967|NCT02474082|Secondary|Dermatology Life Quality Index (DLQI) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|"DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral. The measure was self-administered and included domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. Each item had four response categories ranging from 0 (not at all) to 3 (very much). Not relevant was also a valid response and was scored as 0. The DLQI total score was a sum of the 10 questions. Scores ranged from 0 to 30, with higher scores indicating greater impairment in health related quality of life."|Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for DLQI at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.|||Score on a scale||Standard Deviation|Mean
2574968|NCT02474082|Secondary|Percentage of Participants With IGA Mod. 2011 0/1-response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe. IGA 0/1 responders: who achieved score of 0/1 and improved by at least 2 points on the IGA scale compared to baseline.|Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population.|||Percentage of participants|||Number
2574969|NCT02474082|Secondary|Number of Participants With Investigator's Global Assessment (IGA Mod 2011) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|IGA mod 2011 is a global static severity rating scale referring exclusively to the participant's disease state at the time of the assessments and don't attempt comparison with participant's any previous disease states at baseline or visit. IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. Scores used were: 0/Clear: no signs of psoriasis, Post-inflammatory hyperpigmentation may be present; 1/almost clear: Normal to pink coloration of lesions/no thickening/no to minimal focal scaling; 2/Mild: Pink to light red coloration/just detectable to mild thickening/predominantly fine scaling; 3/Moderate: Dull bright red, clearly distinguishable erythema/clearly distinguishable to moderate thickening/moderate scaling; 4/Severe: Bright to deep dark red coloration/severe thickening with hard edges/severe or coarse scaling covering almost all or all lesions.|Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed in FAS population. Here 'number analyzed' signifies the participants evaluable for IGA mod 2011 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.|||Participants|||Count of Participants
2574970|NCT02474082|Secondary|Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|"NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0-4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop (salmon patch dyschroma). NPASI 100 responders were participants who PASI 100 responders were participants who achieved complete clearance of psoriasis."|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for NAPSI 100 response at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.|||Percentage of participants|||Number
2574971|NCT02474082|Secondary|Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|"NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0-4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop (salmon patch dyschroma). NPASI 90 responders were participants who achieved >=90% improvement (reduction) in NPASI score compared to baseline."|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population. Here 'number analyzed' signifies the participants evaluable for NAPSI 90 response at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.|||Percentage of participants|||Number
2574972|NCT02474082|Secondary|Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|"NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0-4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop (salmon patch dyschroma). NPASI 75 responders were participants who achieved >=75% improvement (reduction) in NPASI score compared to baseline."|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population. Here 'number analyzed' signifies participants evaluable for NAPSI 75 at week 1, 2, 3, 4, 5, 6, 8,12,16, 20 and 24.|||Percentage of participants|||Number
2574973|NCT02474082|Secondary|Percentage of Participants Achieving Nail Psoriasis Severity Index (NAPSI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|"NAPSI was used to assess psoriatic nail involvement in participants with nail psoriasis. NAPSI score was calculated as total of nail matrix and nail bed score, ranging from 0-8 per nail. Total NAPSI score ranges from 0 to 80 for all fingernails. Each nail was divided with imaginary horizontal and longitudinal lines into quadrants. Each nail was given a score of 0 - 4 for nail matrix and nail bed psoriasis 0-4 (0: for none, 1: for 1 quadrant, 2: for 2 quadrants, 3: for 3 quadrants, 4: for all 4 quadrants), based on presence of any feature of nail psoriasis in that quadrant. Nail matrix psoriasis feature includes: pitting, leukonychia red spots in lunula, crumbling. Nail bed psoriasis feature includes: onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop (salmon patch dyschroma). NPASI 50 responders were participants who achieved >=50% improvement (reduction) in NPASI score compared to baseline."|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed on FAS population. Here ‘number analyzed’ signifies participants evaluable for NAPSI 50 at week 1, 2, 3, 4, 5, 6, 7,12,16, 20 and 24.|||Percentage of participants|||Number
2574974|NCT02474082|Secondary|Body Surface Area (BSA) at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The Body surface area (BSA) affected by plaque-type psoriasis was the total of percentages of areas affected, including head, trunk, upper limbs and lower limbs. Each reported percentage was multiplied by its respective body region corresponding factor (head = 0.1, trunk = 0.3, upper limbs = 0.2, lower limbs = 0.4). The resulting four percentages were added to estimate the total BSA affected by plaque-type psoriasis.|Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for BSA at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.|||Percentage of area||Standard Deviation|Mean
2574975|NCT02474082|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 100 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 100 responders were participants who achieved complete clearance of psoriasis (PASI=0).|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 100 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.|||Percentage of participants|||Number
2574976|NCT02474082|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 90 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 90 responders were participants who achieved >=90% improvement (reduction) in PASI score compared to baseline.|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 90 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.|||Percentage of participants|||Number
2574977|NCT02474082|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 1, 2, 3, 4, 6, 8, 12, 16 and 20|PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 75 responders were participants who achieved >=75% improvement (reduction) in PASI score compared to baseline.|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16 and 20|The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 75 at week 1, 2, 3, 4, 6, 8, 12, 16 and 20.|||Percentage of participants|||Number
2575011|NCT02473640|Primary|Ceftriaxone Concentration in Intestinal Chyme Period 2|Ceftriaxone concentration in the presence of SYN-004 and the absence of esomeprazole.|0-8.5 hours|Subjects with functioning illeostomies who received a single IV infusion of 1 g ceftriaxone.|||ug/mL||Standard Error|Mean
2575012|NCT02473640|Primary|Ribaxamase Concentration in Intestinal Chyme Period 1|Concentrations of ribaximase (SYN-004) in intestinal chyme|0-8.5 hours||||ng/mL||Standard Error|Mean
2574978|NCT02474082|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 50 Response at Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 50 responders were participants who achieved >=50% improvement (reduction) in PASI score compared to baseline.|Baseline, Week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24|The analysis was performed in FAS population. Here 'number analyzed' signifies participants evaluable for PASI 50 at week 1, 2, 3, 4, 6, 8, 12, 16, 20 and 24.|||Percentage of participants|||Number
2574979|NCT02474082|Primary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75 Response at Week 24|PASI score is an average degree of severity of signs in head [H], trunk [T], upper limbs [U] and lower limbs [L], assessed separately for erythema [E], thickening (plaque elevation, induration) [I], and scaling (desquamation) [D]. Area [A] covered by lesions on each body region was estimated as a percentage (%) of total area of that particular body region and was assigned a score of 0=0%; 1=1-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. The head and neck, upper limbs, trunk and lower limbs correspond to approximately 10%, 20%, 30% and 40% of the body surface area, respectively. PASI score was calculated as: PASI = 0.1(EH+IH+DH) AH + 0.2(EU+IU+DU) AU + 0.3(ET+IT+DT) AT + 0.4(EL+IL+DL) AL. PASI scores can range from 0 (no signs) to a maximum of 72.0. PASI 75 responders were participants who achieved >=75% improvement (reduction) in PASI score compared to baseline.|Baseline, Week 24|The analysis was performed in Full analysis set (FAS) population, defined as all randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
2574980|NCT02474069|Secondary|Comparative Dose Phase:Summary of IGA Score|The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.|Weeks 18, 22, 26, 30, 32|FAS-CDP: consists of all patients that were randomized and received at least one dose of study drug during the comparative dosing phase and had at least one post-randomization assessment.|||Score on a scale||Standard Deviation|Mean
2574981|NCT02474069|Secondary|Selection Phase: Summary of IGA Score|The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.|Weeks 4, 16|FAS-CDPFAS-SP: consists of all patients that received at least one dose of study drug during the selection phase and had at least one post-baseline assessment.|||Score on a scale||Standard Deviation|Mean
2574982|NCT02474069|Secondary|Comparative Dose Phase: Number of Patients Achieving Investigator Global Assessment (IGA) 0 or 1|The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.|Weeks 18, 22, 26, 30, 32|FAS-CDP: consists of all patients that were randomized and received at least one dose of study drug during the comparative dosing phase and had at least one post-randomization assessment.|||Participants|||Number
2574983|NCT02474069|Secondary|Selection Phase: Number of Patients Achieving Investigator Global Assessment (IGA) 0 or 1|The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.|Weeks 4, 16|FAS-SP: consists of all patients that received at least one dose of study drug during the selection phase and had at least one post-baseline assessment.|||Participants|||Number
2574984|NCT02474069|Secondary|Number of Patients Achieving DLQI Total Score <= 5 in the CDP|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment."|Weeks 4, 16, 18, 22, 26, 30, 32|FAS-CDP: consists of all patients that were randomized and received at least one dose of study drug during the comparative dosing phase and had at least one post-randomization assessment.|||participants|||Number
2574985|NCT02474069|Secondary|Number of Patients Achieving Dermatology Life Quality Index (DLQI) Scores of 0 or 1 by Visits in the CDP|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.~The DLQI was designed to assess health-related quality of life (HRQoL) in adult patients with skin diseases including psoriasis."|Weeks 4, 16, 18, 22, 26, 30, 32|FAS-CDP: consists of all patients that were randomized and received at least one dose of study drug during the comparative dosing phase and had at least one post-randomization assessment.|||participants with DLQI score 0/1|||Number
2575013|NCT02473640|Primary|Ceftriaxone Concentration in Intestinal Chyme Period 1|Ceftriaxone concentration in the presence of SYN-004 and the absence of esomeprazole.|0-8.5 hours|Subjects with functioning illeostomies who received a single IV infusion of 1 g ceftriaxone.|||ug/mL||Standard Error|Mean
2576132|NCT02454101|Secondary|Severe Postpartum Haemorrage|(measured blood loss 1000 mL or more|24 hours after labor||||participants|||Number
2574986|NCT02474069|Secondary|Comparative Dose Phase: Summary of PASI Total Score|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Weeks 18, 22, 26, 30 and 32|FAS-CDP: consists of all patients that were randomized and received at least one dose of study drug during the comparative dosing phase and had at least one post-randomization assessment.|||Score on a Scale||Standard Deviation|Mean
2574987|NCT02474069|Secondary|Selection Phase:Summary of PASI Total Score|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|at weeks 1,2,3,4,8, 12, 16|FAS-SP: consists of all patients that received at least one dose of study drug during the selection phase and had at least one post-baseline assessment.|||Score on a Scale||Standard Deviation|Mean
2574988|NCT02474069|Secondary|Comparative Dose Phase: Number of Participants Achieving Psoriasis Area and Severity Index Score (PASI) 90 and 100|Number of participants with at least 90 or 100% improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|at weeks 18, 22, 30, 32|FAS-CDP: consists of all patients that were randomized and received at least one dose of study drug during the comparative dosing phase and had at least one post-randomization assessment.|||Number of participants|||Number
2574989|NCT02474069|Secondary|Selection Phase: Number of Participants Achieving (Psoriasis Area and Severity Index Score)PASI 50, 75, 90, 100|Number of participants with at least 50, 75, 90 or 100% improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|at weeks 1, 2, 3, 4, 8, 12 and 16|FAS-SP: consists of all patients that received at least one dose of study drug during the selection phase and had at least one post-baseline assessment.|||Number of participants|||Number
2574990|NCT02474069|Primary|Number of Participants With PASI 90 Response at Week 32 for PPS|Number of participants with at least 90% improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|at week 32|PPS: consisted of all patients from the FAS-CDP who completed the study without any major protocol deviation.|||participants|||Number
2574991|NCT02474069|Primary|Number of Participants With PASI 90 Response at Week 32|Number of participants with at least 90% improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|at 32 weeks|Full Analysis Set (FAS) - Comparative Dosing Phase (CDP): consisted of all patients who were randomized and received at least one dose of study drug during the CDP and had at least one post-randomization assessment. Patients with missing PASI at week 32 were counted as non-responders, unless they were responders already at their last reported PASI.|||participants|||Number
2574992|NCT02473991|Primary|Placental Thickness at 3rd Trimester||30-34 weeks of pregnancy||||millimeter||Standard Deviation|Mean
2574993|NCT02473991|Primary|Placental Thickness in Second Trimester|placental thickness measured in millimeter|15-20 weeks of gestation||||millimeter||Standard Deviation|Mean
2574994|NCT02473991|Primary|Fetal Weight (Fetal Weight at Birth)|Fetal weight (fetal weight at birth) (in grams)|9 months||||gram||Standard Deviation|Mean
2574995|NCT02473965|Secondary|Median Time to First Episode of MG Worsening|The time to the first episode of MG worsening was defined as the time between baseline and the first instance of QMG total score increase by ≥4 points relative to Baseline/Week 0. The QMG total score is the sum of all 13 items and ranges from 0 to 39. Higher values represent greater severity of illness. If one or more items were missing at a given assessment, the total score was set to missing. The median time to MG worsening was calculated based on Kaplan-Meier methodology. Baseline was defined as the last non-missing measurement taken prior to the first dose of study medication.|From Baseline/Week 0 (Visit 1) to Week 39 (Visit 14).|The mITT population included all randomized subjects who received at least 1 dose of study medication. Subjects were classified according to randomized treatment.|||weeks||Inter-Quartile Range|Median
2575014|NCT02473523|Other Pre-specified|Median Change in Verbal Numeric Pain Scale|Summary statistics of mean ± standard error will be provided. Longitudinal change for the numeric pain scale across the yoga session will be reported.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
2615589|NCT01999192|Secondary|DAS28||up to 48 weeks|||||||
2574996|NCT02473965|Secondary|Mean Percent Change in Daily CS Dose (Prednisone or Equivalent) From Baseline to Week 39|The average daily CS dose was derived for each subject at each scheduled visit based on the prescribed dose and the time interval taking into account any prescribed dose changes between routinely scheduled visits. For subjects who discontinued the study early with adverse outcomes related to MG, the missing dose reduction at Week 39 was imputed using the WOCF method. For subjects who had missing CS dose reduction at Week 39 due to other reasons, the missing CS dose was imputed using the LOCF method. Baseline was defined as the last non-missing measurement taken prior to first dose of study medication. The least squares (LS) mean percent change from baseline in daily CS dose to Week 39 is presented for each treatment group.|Baseline/Week 0 (Visit 1) and Week 39 (Visit 14).|The mITT population included all randomized subjects who received at least 1 dose of study medication. Subjects were classified according to randomized treatment.|||percent change||Standard Error|Least Squares Mean
2574997|NCT02473965|Primary|Percent of Subjects Achieving a 50% or Greater Reduction in CS Dose (Prednisone or Equivalent) From Baseline to Week 39|The average daily CS dose was derived for each subject at each scheduled visit based on the prescribed dose and the time interval taking into account any prescribed dose changes between routinely scheduled visits. Subjects who discontinued the study early with adverse outcomes related to MG were considered as not achieving a 50% or greater reduction. The missing dose reduction at Week 39 was imputed using the worst observation carried forward (WOCF) method. For subjects who did not have CS dose prescribed at Week 39 due to other reasons, the last observation carried forward (LOCF) method was used to impute the prescribed CS dose at Week 39. Baseline was defined as the last non-missing measurement taken prior to first dose of study medication. The percent of subjects achieving ≥50% reduction in CS dose from baseline to Week 39 is presented for each treatment group overall and for the baseline daily prednisone equivalent dose level stratification categories.|Baseline/Week 0 (Visit 1) and Week 39 (Visit 14).|The mITT population included all randomized subjects who received at least 1 dose of study medication. Subjects were classified according to randomized treatment.|||percentage of subjects|||Number
2574998|NCT02473952|Primary|Improvement in Myasthenia Gravis (MG) Symptoms as Measured by the Mean Change in Quantitative Myasthenia Gravis (QMG) Total Score.|To measure improvement in MG symptoms by the mean change in QMG total score from Baseline (Week 0) to Week 24 as compared to placebo. Evaluators score 13 individual items (range from 0=best to 3=worst) and the individual scores are added together for the total score (range 0-39). An average 3-point improvement in QMG score indicates clinically meaningful improvement.|Baseline (Week 0) to Week 24|Modified intent-to-treat population consisting of all randomized subjects who received at least 1 dose of study medication.|||units on a scale||Standard Deviation|Mean
2574999|NCT02473783|Secondary|Safety Assessments - the Tolerability of Injection of I-123-ADAM Solution|Pain Scores as measured by the Visual Analog Scale (0-10) for the tolerability of injection of I-123-ADAM solution. Higher values represent a worse outcome.|assessed at -5~0 days and 6 weeks ±5 days, -5~0 days reported (I-123-ADAM SPECT scan)|All the participants in the Intention -to-treatment group completed the study.|||units on a scale||Standard Deviation|Mean
2575000|NCT02473783|Secondary|Hamilton Depression Rating Scale (HAM-D) Total Scores|The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. It contains 17 items to be rated. Each item on the questionnaire is scored on a 3 or 5 point scale. The range of the total score (summed) is from 0 to 52.The higher total score suggests the more severe depression.|6 weeks|All the participants in the Intention -to-treatment group completed the study. Since the healthy control group did not receive the pharmacological intervention, they underwent only the baseline assessments but not the follow-up ones. Therefore, we reported only the outcome measures of the treatment group.|||units on a scale||Standard Deviation|Mean
2575001|NCT02473783|Primary|The SERT Binding Potential (BP) --(Only the Treatment Group Was Assessed)|Binding potential (BP) is a ratio of specific to non-displaceable binding (BP = (target region － cerebellum) / cerebellum)|6 weeks (The Healthy control Group only had the scanning at baseline)|All the participants in the Intention -to-treatment group completed the study. Since the healthy control group did not receive the pharmacological intervention, they underwent only the baseline assessments but not the follow-up ones. Therefore, we reported only the outcome measures of the treatment group.|||a ratio of target region to background||Standard Deviation|Mean
2575002|NCT02473718|Secondary|Mortality|Percentage of patients who died during their ICU stay|ICU stay, median of 10 days||||Participants|||Count of Participants
2575003|NCT02473718|Secondary|Mortality|Percentage of patients who died during their hospitalization|Hospital stay, median of 16 days||||Participants|||Count of Participants
2575004|NCT02473718|Secondary|Rate of Renal Replacement Therapy|Percentage of patients requiring renal replacement therapy|ICU stay, median of 10 days||||Participants|||Count of Participants
2575005|NCT02473718|Secondary|Ventilator Days|Number of days requiring mechanical ventilation support, including continuous noninvasive positive pressure ventilation|Hospital stay, median of 16 days||||days||Inter-Quartile Range|Median
2575006|NCT02473718|Primary|Net Fluid Balance|Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 5|Day 5||||mL||Inter-Quartile Range|Median
2575007|NCT02473718|Primary|Net Fluid Balance|Difference between cumulative volume of all IV fluids administered and all outputs in mL by day 3|Day 3||||mL||Inter-Quartile Range|Median
2575008|NCT02473718|Primary|Cumulative Fluid Administered|Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 5|Day 5|Five patients in the fluid minimization group and four patients in the usual care group died prior to analysis at day 5. Five patients in the fluid minimization group and six patients in the usual care group were transferred out of the ICU prior to analysis at day 5.|||mL of study fluid||Inter-Quartile Range|Median
2575009|NCT02473718|Primary|Cumulative Fluid Administered|Cumulative volume of crystalloid boluses, continuous infusions, and colloid fluids administered in mL by day 3|Day 3|Five patients in the fluid minimization group and two patients in the usual care group died prior to the first time point analysis at day three. One patient in the usual care group was transferred out of the ICU prior to the first time point analysis at day 3.|||mL of study fluid||Inter-Quartile Range|Median
2575010|NCT02473640|Primary|Ribaxamase Concentration in Intestinal Chyme Period 2|Concentrations of ribaximase (SYN-004) in intestinal chyme|0-8.5 hours||||ng/mL||Standard Error|Mean
2575015|NCT02473523|Other Pre-specified|Mean Change in Verbal Numeric Pain Scale|Summary statistics of mean ± standard error will be provided. Longitudinal change for the numeric pain scale across the yoga session will be reported.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
2575016|NCT02473523|Other Pre-specified|Median Change in Balance|Median (range) on the Bruininks-Oseretsky Test of Motor Proficiency will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
2575017|NCT02473523|Other Pre-specified|Mean Change in Balance|Mean ± standard error on the Bruininks-Oseretsky Test of Motor Proficiency will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
2575018|NCT02473523|Other Pre-specified|Median Change in Hamstring Flexibility|Hamstring flexibility will be assessed by the Sit and Reach Test. Median (range) will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
2575019|NCT02473523|Other Pre-specified|Mean Change in Hamstring Flexibility|Hamstring flexibility will be assessed by the Sit and Reach Test. Mean ± standard error will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
2575020|NCT02473523|Other Pre-specified|Median Change in Grip Strength|"A calibrated Jamar hydraulic hand dynamometer will be used to measure grip strength. Median (range) will be provided."|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
2575021|NCT02473523|Other Pre-specified|Mean Change in Grip Strength|"A calibrated Jamar hydraulic hand dynamometer will be used to measure grip strength. Mean ± standard error will be provided."|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
2575022|NCT02473523|Other Pre-specified|Median Change in Quadriceps Strength|"The Biodex System 3 Dynamometer will be utilized to measure isometric quadriceps muscle contractions. Median (range) will be provided."|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
2575023|NCT02473523|Other Pre-specified|Mean Change in Quadriceps Strength|"The Biodex System 3 Dynamometer will be utilized to measure isometric quadriceps muscle contractions. Mean ± standard error will be provided."|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
2575024|NCT02473523|Other Pre-specified|Median Change in PedsQL Multidimensional Fatigue Scale|Median (range) will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
2575025|NCT02473523|Other Pre-specified|Mean Change in PedsQL Multidimensional Fatigue Scale|Mean ± standard error will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
2575026|NCT02473523|Other Pre-specified|Median Change in PedsQL Cancer Module Score|Median (range) will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
2575027|NCT02473523|Other Pre-specified|Mean Change in PedsQL Cancer Module Score|Mean ± standard error will be provided.|Baseline at initial evaluation to follow-up evaluation (up to 6 weeks later)|||||||
2575028|NCT02473523|Primary|Rate of Patients Who Complete the Study|The rate of enrolled and consented patients who complete the 60-minute yoga sessions offered over a 4-6 week period to the total number of participants on the study. It is hypothesized that 60% of those participants will complete the intervention. Thus, if more than 5 patients can not complete the intervention, then it will be concluded that the trial is not feasible.|At end of 4-6 weeks|||||||
2575029|NCT02473523|Primary|Rate of Patients Who Are Willing to Participate|The rate of participants who are willing to participate on this protocol to the total number of participants approached. It is anticipated that 50% approached patients will agree to participate on the study. Twenty five patients will be approached and asked to participate in the study. If more than 6 patients out of 25 approached patients refuse to participate in the study, the study will be closed, and it will be concluded that the trial is not feasible.|Day 0|||||||
2575030|NCT02473510|Secondary|Percentage of Participants Who Require Antipyretic and/or Analgesic Medication|Percentage of participants who require antipyretic and/or analgesic medication were reported.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.|||Percentage of Participants|||Number
2575031|NCT02473510|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Disease (NOCDs)|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs were serious events between administration of study drug and up to 181 days after the dose that are absent before treatment or that worsen relative to pretreatment state. An NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature and is assessed by the investigator as medically significant. Results were given for TESAEs and NOCDs reported within 29 days and 181 days after vaccination.|Baseline (Day 1) up to Day 29 and 181|The ITT population included all participants that were randomized and treated with investigational product.|||Participants|||Number
2575032|NCT02473510|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were events between administration of study drug and up to 15 days after vaccination that are absent before treatment or that worsened relative to pre-treatment state. Results were given for AEs reported within 8 days and 15 days after vaccination.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.|||Participants|||Number
2575033|NCT02473510|Secondary|Percentage of Participants With Solicited Symptoms|Solicited symptoms are predefined symptoms or events specifically inquired about and assessed daily after vaccine administration up to 15 days after vaccination. The solicited symptoms include fever greater than (>) 100.0 degrees F (37.8 degrees Celsius), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity and headache. Results were reported for all solicited symptoms except fever >=101 degrees F (reported as primary outcome) within 8 days after vaccination and all solicited symptoms within 15 days after vaccination.|Baseline (Day 1) up to Day 8 and Day 15|The ITT population included all participants that were randomized and treated with investigational product.|||Percentage of Participants|||Number
2575034|NCT02473510|Primary|Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)|Percentage of participants with fever defined as oral temperature >=101 degrees F were reported.|Baseline (Day 1) up to Day 8|The intent-to-treat (ITT) population included all participants that were randomized and treated with investigational product.|||Percentage of Participant|||Number
2575035|NCT02473471|Secondary|Menstrual Cycle|the relationship between the rate of tooth movement and Menstrual cycle|within 3 months|Sufficient data were not collected from any participant||||||
2575036|NCT02473471|Secondary|Patient Satisfaction|It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = unsatisfied and 10 = most satisfaction.|After 7 days of MOP application||||units on a scale||Standard Deviation|Mean
2575037|NCT02473471|Secondary|Pain Interference /Discomfort|It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no discomfort and 10 = worst discomfort.|within 7 days after the intervention||||units on a scale||Standard Deviation|Mean
2575038|NCT02473471|Secondary|Pain Interference /Swelling of the Surgical Side|It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no swelling and 10 = worst swelling.|within 7 days after the intervention||||units on a scale||Standard Deviation|Mean
2575039|NCT02473471|Secondary|Pain Interference /Pain Interrupted Sleep|It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain.|within 7 days after the intervention||||units on a scale||Standard Deviation|Mean
2575040|NCT02473471|Secondary|Pain Interference /Pain During Eating?|It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain.|within 7 days after the intervention||||units on a scale||Standard Deviation|Mean
2575041|NCT02473471|Secondary|Pain Intensity|It will be evaluated by using Visual Analog Scale (VAS) from 0 to 10 Numeric Rate Scale in which 0 = no pain and 10 = worst pain.|within 7 days after the intervention||||units on a scale||Standard Deviation|Mean
2575042|NCT02473471|Secondary|Root Resorption|It will be evaluated by taking periapical radiograph for canines before canine retraction and after 3 months period|Baseline to 3rd month||||mm||Standard Deviation|Mean
2575043|NCT02473471|Primary|Intra Oral Measurements of Canine Rate of Tooth Movement|Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.|Baseline to 3 month|32 subjects were analyzed who received MOP to either right or left sides.|||mm||Standard Deviation|Mean
2575044|NCT02473471|Primary|Intra Oral Measurements of Canine Rate of Tooth Movement|Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.|Baseline to 2nd month|32 subjects were analyzed to receive MOP to either right or left sides.|||mm||Standard Deviation|Mean
2575045|NCT02473471|Primary|Intra Oral Measurements of Canine Rate of Tooth Movement|Direct intraoral measurement of the distance between canine and second premolar in the patient's mouth was done every week using a digital caliper, from the upper mesial wing of the canine bracket to upper distal wing of second premolar bracket in both right and left sides parallel to the occlusal plane for 3 months.|Baseline to 1st month|32 subjects were analyzed to receive MOP to either right or left sides. Only one patient was lost to follow up at the first month time point.|||mm||Standard Deviation|Mean
2575046|NCT02473471|Primary|3D Digital Model Measurements of Canine Rate of Tooth Movement|The baseline 3D digital model was superimposed to 3D digital models of 3rd month to determine the anterioposterior displacement of canines.|Baseline to 3rd month|Thirty-five subjects were randomized to receive MOP to either right or left sides with 1:1 allocation ratio. Three impressions were missing at first month due to alginate distortion, and only one impression was lost to be taken by a clinician at two months.|||mm||Standard Deviation|Mean
2575047|NCT02473471|Primary|3D Digital Model Measurements of Canine Rate of Tooth Movement|The baseline 3D digital model was superimposed to 3D digital models of 2nd month to determine the anterioposterior displacement of canines.|Baseline to 2nd month|Thirty-five subjects were randomized to receive MOP to either right or left sides with 1:1 allocation ratio. only one impression was lost to be taken by a clinician at two months period.|||mm||Standard Deviation|Mean
2575048|NCT02473471|Primary|3D Digital Model Measurements of Canine Rate of Tooth Movement|The baseline 3D digital model was superimposed to 3D digital models of the 1st month to determine the anterioposterior displacement of canines.|Baseline to 1st month|Thirty-five subjects were randomized to receive MOP to either right or left sides with 1:1 allocation ratio. Three impressions were missing at first month due to alginate distortion.|||mm||Standard Deviation|Mean
2575049|NCT02473445|Secondary|Change Over Time in Pharmacodynamic Biomarkers|Change from baseline in glutathione, glutathione disulfide, and lactate analyses were not performed as the study was prematurely terminated.|Baseline, every 3 months and Study Exit (up to 24 Months)|The study was closed prematurely due to lack of efficacy demonstrated in base study RP103-MITO-001. As a result, only a limited amount of data was collected for patients that were enrolled prior to termination. The decision was made that the data were not complete enough, and no analyses were conducted.||||||
2575050|NCT02473445|Secondary|Change Over Time in Two of the Most Pre-eminent Symptoms|The two pre-eminent symptoms previously identified in study RP103-MITO-001 were to be continued to be assessed during the extension study. Symptoms included myopathy, dystonia, ataxia, retarded motor development, reduced activities of daily living, and vision.|Baseline, every 3 months and Study Exit (up to 24 Months)|The study was closed prematurely due to lack of efficacy demonstrated in base study RP103-MITO-001. As a result, only a limited amount of data was collected for patients that were enrolled prior to termination. The decision was made that the data were not complete enough, and no analyses were conducted.||||||
2575064|NCT02472977|Primary|Number of Participants With Electrocardiogram Abnormalities|The number of participants experiencing electrocardiogram abnormalities was reported for each arm|From first dose to date of last dose plus 30 days|Electrocardiogram data was not collected for any participants||||||
2596887|NCT02203630|Secondary|Number of Days Without Vasopressor Use|Shock free days|Up to 28 days||||days|||Number
2575051|NCT02473445|Primary|Change in Newcastle Paediatric Mitochondrial Disease Scale (NPMDS) Score|"The NPMDS evaluates the progression of mitochondrial disease in pediatric patients in 4 domains:~I - Current Function (vision, hearing, communication, feeding, and mobility) with scores ranging from 0 to 21;~II - System Specific Involvement (seizures, encephalopathy, bleeding diathesis or coagulation defects, gastrointestinal, endocrine, respiratory, cardiovascular, renal, liver, and blood) with scores ranging from 0 to 30.~III - Current Clinical Assessment (growth and development over past 6 months, vision, strabismus and eye movement, myopathy, ataxia, pyramidal, extrapyramidal, and neuropathy) with scores ranging from 0 to 28;~IV - Quality of Life with scores ranging from 0 to 25. For sections I-III, higher scores reflect more severe disease. For Section IV, a higher score reflects a lower quality of life."|Baseline, every 3 months and Study Exit (up to 24 Months)|The study was closed prematurely due to lack of efficacy demonstrated in base study RP103-MITO-001. As a result, only a limited amount of data was collected for patients that were enrolled prior to termination. The decision was made that the data were not complete enough, and no analyses were conducted.||||||
2575052|NCT02473367|Primary|Plasma Concentration at 24 Hrs Post-dose (C24hr) of Raltegravir Following Once Daily Administration of Raltegravir|In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected at 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means.|24 hours post-dose|Per-Protocol: Participants who complied with the protocol sufficiently to ensure that generated data would reflect the effects of treatment, according to the underlying scientific model.|||nM||95% Confidence Interval|Least Squares Mean
2575053|NCT02473367|Primary|Maximum Plasma Concentration (Cmax) of Raltegravir Following Once Daily Administration of Raltegravir|In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS US 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid MS taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and ANOVA modeling was performed on natural log-transformed values to derive geometric least-squares means.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Per-Protocol: Participants who complied with the protocol sufficiently to ensure that generated data would reflect the effects of treatment, according to the underlying scientific model.|||nM||95% Confidence Interval|Least Squares Mean
2575054|NCT02473367|Primary|Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hrs (AUC 0-24hr) of Raltegravir Following Once Daily Administration of Raltegravir|In Period 1 participants were treated with 1200 mg raltegravir alone; followed by Period 2 where participants were treated with 1200 mg raltegravir and three tablets of TUMS Ultra Strength (US) 1000 taken orally concomitantly; followed by Period 3 where participants were treated with 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid Maximum Strength (MS) taken orally; followed by Period 4 where participants were treated with 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. The wait between Periods was a maximum of 7 days, during which participants were treated with 1200 mg raltegravir once daily. To determine the plasma concentration of raltegravir, blood samples were collected from pre-dose up to 24 hours post-dose, and analysis of variance (ANOVA) modeling was performed on natural log-transformed values to derive geometric least-squares means.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Per-Protocol: Participants who complied with the protocol sufficiently to ensure that generated data would reflect the effects of treatment, according to the underlying scientific model.|||hr*µM||95% Confidence Interval|Least Squares Mean
2575055|NCT02473289|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Weeks 1, 4, 8, 12, 16, and 22|"The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score] for all except for 2 items: I have energy and I am able to do my usual activities), and ranges from 0 to 52, with a higher score indicating less fatigue."|Baseline and Weeks 1, 4, 8, 12, 16, and 22|mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'n' (number of participants analyzed)- number of participants analyzed at each specified timepoint, for each arm.|||Units on a scale||Standard Deviation|Mean
2575056|NCT02473289|Secondary|Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 2) at Weeks 1, 4, 8, 12, 16, and 22|The Snaith-Hamilton Pleasure Scale (SHAPS) is short, 14-item instrument to measure anhedonia. Each of the 14 items has a set of four response categories (Definition 2): Definitely Agree (= 0), Agree (= 0), Disagree (= 1), and Definitely Disagree (= 1). A SHAPS total score was calculated as the sum of the 14 item scores with a score range from 0 to 14. A higher total score indicates higher levels of state anhedonia.|Baseline and Weeks 1, 4, 8, 12, 16, and 22|mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'n' (number of participants analyzed)- number of participants analyzed at each specified timepoint, for each arm.|||Units on a scale||Standard Error|Least Squares Mean
2575101|NCT02472522|Other Pre-specified|Visual Analogue Scale on Coughing (VAS-C)|Visual Analogue Scale on Coughing (VAS-C) Was Used to Assess Post-operative Pain on Coughing. Where: 0 = no Pain and 10 = Worst Imaginable Pain. They were Recorded on Shifting to Postoperative and Then at 1, 4, 8, 12, 18 and 24 Hour|24 hours||||Units on a scale||Standard Deviation|Mean
2575057|NCT02473289|Secondary|Change From Baseline in Snaith Hamilton Pleasure Scale (SHAPS) Total Score (Definition 1) at Weeks 1, 4, 8, 12, 16, and 22|The Snaith-Hamilton Pleasure Scale (SHAPS) is short, 14-item instrument to measure anhedonia. Each of the 14 items has a set of four response categories (Definition 1): Definitely Agree (=1), Agree (= 2), Disagree (= 3), and Definitely Disagree (= 4). A SHAPS total score was calculated as the sum of the 14 item scores with a total score range from 14 to 56. A higher total score indicates higher levels of state anhedonia.|Baseline and Weeks 1, 4, 8, 12, 16, and 22|mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'n' (number of participants analyzed)- number of participants analyzed at each specified timepoint, for each arm.|||Units on a scale||Standard Error|Least Squares Mean
2575058|NCT02473289|Secondary|Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Weeks 1, 4, 8, 12, 16, and 22|The PHQ-9 used as a participant-reported measure of depressive symptomatology. The PHQ-9 is 9-item scale, where each item is rated on a 4-point scale (0=Not at all, 1=Several Days, 2=More than half the days, and 3=Nearly every day). The participant's item responses were summed to provide a total score range of 0 to 27. Higher scores indicates greater severity of depressive symptoms. The recall period is 2 weeks.|Baseline and Weeks 1, 4, 8, 12, 16, and 22|mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'n' (number of participants analyzed)- number of participants analyzed at each specified timepoint, for each arm.|||Units on a scale||Standard Error|Least Squares Mean
2575059|NCT02473289|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score at Weeks 1, 4, 8, 12, 16, and 22|CGI-S defined as clinician-rated scale that assesses the severity of mental illness on a scale of 0 to 7. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to:1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; 7: among the most extremely ill patients. A higher score implies a more severe condition.|Baseline and Weeks 1, 4, 8, 12, 16, and 22|mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'n' (number of participants analyzed)- number of participants analyzed at each specified timepoint, for each arm.|||Units on a scale||Standard Error|Least Squares Mean
2575060|NCT02473289|Secondary|Percentage of Participants With Response as Assessed by HDRS-17 Total Score at Week 12|Response- Percentage of participants with greater than or equal to (>=) 50 percent (%) improvement on the HDRS-17 total score from baseline at Week 12 were considered as responders. The HDRS-17 defined as clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition.|Week 12|mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'N' (number of participants analyzed)- number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
2575061|NCT02473289|Secondary|Percentage of Participants With Remission as Assessed by HDRS-17 Total Score at Week 12|Remission- Percentage of participants with HDRS-17 total score less than or equal to (<=) 7 were considered as remitters. HDRS-17 defined as clinician-administered rating scale designed to assess severity of symptoms in participants diagnosed with depression with score range of 0 to 52. Each of 17 items is rated by clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (0 to 52) was calculated by adding scores of all 17 items. For each item as well as total score, a higher score represents a more severe condition.|Week 12|mITT1 analysis set: all randomized participants with hsCRP >=3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'N' (number of participants analyzed)- number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
2575062|NCT02473289|Secondary|Change From Baseline in HDRS-17 Total Score at Weeks 1, 4 and 8|The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition.|Baseline, Weeks 1, 4 and 8|mITT1 analysis set: all randomized participants with hsCRP >= 3.00 mg/L at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in DB treatment period. 'n' (number of participants analyzed)- number of participants analyzed at each specified timepoint, for each arm.|||Units on a scale||Standard Error|Least Squares Mean
2575063|NCT02473289|Primary|Change From Baseline in Hamilton Depression Rating Scale (HDRS-17) Total Score at Week 12|The HDRS-17 is a clinician-administered rating scale designed to assess the severity of symptoms in participants diagnosed with depression with a score range of 0 to 52. Each of the 17 items is rated by the clinician on either a 3-point (0 to 2) or a 5-point scale (0 to 4). The point scale used a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). A total score (0 to 52) was calculated by adding the scores of all 17 items. For each item as well as the total score, a higher score represents a more severe condition. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|Baseline and Week 12|Modified Intent-to-treat 1 (mITT1) analysis set: all randomized participants with high sensitivity c-reactive protein (hsCRP) >= 3.00 milligram per liter (mg/L) at screening and baseline who receive at least 1 dose of study drug and have both baseline and at least one postbaseline HDRS-17 total score in double-blind (DB) treatment period.|||Units on a scale||Standard Error|Least Squares Mean
2575065|NCT02472977|Secondary|Progression-Free Survival (PFS)|Progression-free survival is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by the investigator according to RECIST 1.1 criteria, or death due to any cause, whichever occurs first. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. PFS was not assessed for this study due to the small number of participants.|From first dose to date of progression (assessed up to January 2017, approximately 18 months)|PFS data was not collected for any participants||||||
2575066|NCT02472977|Primary|Number of Participants With Laboratory Abnormalities|The number of participants who experienced on-study Grade 3 or 4 laboratory abnormalities (without Grade 3 or 4 abnormality at baseline) was reported for each arm.|From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)|All treated participants in PAC arms. Lab abnormality data was not collected for SCLC arm.|||Participants|||Number
2575067|NCT02472977|Primary|Overall Survival (OS)|If a Phase 2 comparative study is initiated and, for PAC only: Overall Survival is defined as the time from randomization to date of death due to any cause.|From date of randomization to date of death (assessed up to study completion, approximately 18 months)|OS data was not collected for any participants||||||
2575068|NCT02472977|Primary|Objective Response Rate (ORR) Per RECIST 1.1 Criteria|ORR is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants. BOR is defined as the best response designation recorded between the first dose date and the date of progression per RECIST 1.1, or the date of subsequent anti-cancer therapy, whichever occurs first. CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions, referencing the smallest sum on study, and an absolute increase of at least 5 mm, or the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing the smallest sum diameters while on study.|From first dose until disease progression or treatment discontinuation (assessed up to January 2017, approximately 18 months)|All treated participants in PAC arms. ORR data was not collected for SCLC arm.|||Percentage of participants||90% Confidence Interval|Number
2575069|NCT02472977|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Immune-mediated AEs|The number participants who experienced on-study AEs, SAEs, and AEs requiring immune modulating medication is reported.|From first dose until date of last dose of ulocuplumab or nivolumab plus 100 days (assessed up to January 2017, approximately 18 months)|All treated participants. Participants in the SCLC (Tot) Arm were not evaluated for Immune-mediated AEs|||Participants|||Number
2575070|NCT02472964|Primary|Primary Endpoint : Compare Best Overall Response Rate (ORR) (According to Response Evaluation Criteria in Solid Tumor [RECIST] 1.1 Criteria) at Week 24 of MYL-1401O Plus Taxane Versus Herceptin® Plus Taxane in the ITT1 Population|"Tumor measurements were perform by centralized blinded reviewers using RECIST 1.1 criteria. Per RECIST 1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to <10 mm.Partial Response (PR): >/= 30% decrease sum of the diameters of target lesions from baseline sum diameters.~Progressive Disease (PD): </= 20% increase in the sum of the diameters of target lesions, from the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions* denotes disease progression.~Stable Disease (SD): Neither sufficient decrease or increase. Evaluation of Non-Target Lesions Complete Response (CR): Disappearance of all non-target lesions. Non-complete Response/Non-Progressive Disease: Persistence of one or more non-target lesions. Progressive Disease (PD): Substantial, unequivocal progression of existing non-target lesions."|from time of First treatment to week 24|The primary efficacy analysis was conducted in the Intent To Treat population 1 (ITT1) ( all patients randomized after Amendment 2 of the protocol)|||Participants|||Count of Participants
2575071|NCT02472886|Secondary|For HIV/HCV- Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4||Up to Posttreatment Week 4|Participant in the Safety analysis set (with or without prior antiretroviral (ARV) treatment) with available data were analyzed.|||cells/µL||Standard Deviation|Mean
2575072|NCT02472886|Secondary|Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4||Up to Posttreatment Week 4|Participants in the Safety Analysis Set (who had HIV RNA < 50 Copies/mL at baseline) with available data were analyzed.|||percentage of participants|||Number
2575073|NCT02472886|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure~confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),~confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound), HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie, nonresponse)~Relapse~HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2575074|NCT02472886|Secondary|HCV RNA Change From Day 1||Up to 12 weeks|Participants in Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2575075|NCT02472886|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Up to 12 weeks|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2575076|NCT02472886|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2575077|NCT02472886|Primary|Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE)||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
2575100|NCT02472522|Other Pre-specified|Short Assessment of Patient Satisfaction Score (SAPS)|"Short assessment of patient satisfaction score(SAPS) was assessed on a 5 point scale at the end of 24 hours on the quality of postoperative analgesia. where:~highly dissatisfied~dissatisfied~neither dissatisfied nor satisfied~satisfied~highly satisfied"|24 hours||||Units on a scale||Standard Deviation|Mean
2575078|NCT02472886|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set (FAS) included participants who were enrolled into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2575079|NCT02472847|Primary|BOLD Signal Measured by Functional Magnetic Resonance Imaging (fMRI)|Mean BOLD hippocampal signal during extinction learning and retention task in brain responsebetween the placebo (PBO) and the dronabinol (THC) group. Target areas are analyzed from fMRI scans. The scans were completed on days 1, 2, 3, and 9. Participants were randomized to the PBO and THC condition and received either placebo or dronabinol on day 2, 2 hours prior to extinction learning. Data from days 1, 2, 3, & 9 was combined and a single value was averaged for each group.|Day 1, 2, 3, & 9|The number of participants analyzed is 22 in the placebo group and 18 in the dronabinol group. The total number of participants who completed all 4 scanning sessions is 44. 4 participants were excluded from data analysis due to having poor quality fMRI data from any of the four sessions.|||parameter estimates (arbitrary units)||Standard Deviation|Mean
2575080|NCT02472795|Post-Hoc|Total Lymphocyte Count Percent Change From Baseline to End-of-treatment (EOT)|"Percentage change in total lymphocyte count from baseline to end-of-treatment (EOT).~Percent change from baseline is defined as the absolute change from baseline divided by the baseline value (if the baseline value is > 0) and then multiplied by 100.~A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased.~The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect.~The modified pharmacodynamics analysis set includes all participants who:~received at least 21 days of study treatment &~with lymphocyte count measurements at baseline and post-baseline (namely, one sample taken at least 21 days after the first study treatment intake and no later than 7 days after the last study treatment intake with no treatment interruption documented in the first 21 days) &~with cenerimod plasma concentrations at Week 4 consistent with expectations."|Baseline to End of Treatment (EOT) (up to 12 weeks)|Ctrough levels were discovered to be low, or below the lower limit of quantification (BLQ), in four patients randomized to the cenerimod 4 mg group, a finding incompatible with compliance with study treatment. These patients were excluded from the pharmacodynamic set to form a modified pharmacodynamic analysis set.|||Percent change of total lymphocyte count||Standard Deviation|Mean
2575081|NCT02472795|Post-Hoc|Absolute Values of Total Lymphocyte Count at Each Analysis Visit|"The primary objective of the clinical study was to see whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE).~The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect.~The modified pharmacodynamics analysis set includes all participants who:~received at least 21 days of study treatment &~with lymphocyte count measurements at baseline and post-baseline (namely, one sample taken at least 21 days after the first study treatment intake and no later than 7 days after the last study treatment intake with no treatment interruption documented in the first 21 days) &~with cenerimod plasma concentrations at Week 4 consistent with expectations."|Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment (EOT - up to 12 weeks), end-of-study (6 weeks after EOT)|All participants for which data was available. Ctrough levels were discovered to be low, or below the lower limit of quantification (BLQ), in four patients randomised to the cenerimod 4 mg group, a finding incompatible with compliance with study treatment. These patients were excluded from the PD set to form a modified pharmacodynamic analysis set.|||10^9 cells/L||Standard Deviation|Mean
2575082|NCT02472795|Post-Hoc|Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT) Based on Pharmacokinetic Cthrough Profiles|"The change was defined as: Total lymphocyte count at end-of-treatment (EOT) minus total lymphocyte count at baseline.~A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased.~The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake.~End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12.~The modified pharmacodynamics analysis set includes all participants who:~received at least 21 days of study treatment &~with lymphocyte count measurements at baseline and post-baseline (namely, one sample taken at least 21 days after the first study treatment intake and no later than 7 days after the last study treatment intake with no treatment interruption documented in the first 21 days) &~with cenerimod plasma concentrations at Week 4 consistent with expectations."|Baseline to end-of-treatment (EOT) (up to 12 weeks)|Ctrough levels were discovered to be low, or below the lower limit of quantification (BLQ), in four patients randomized to the cenerimod 4 mg group, a finding incompatible with compliance with study treatment. These patients were excluded from the pharmacodynamic analysis set to form a modified pharmacodynamics analysis set.|||10^9 cells/L||Standard Deviation|Mean
2575083|NCT02472795|Primary|Change in Total Lymphocyte Count From Baseline to Each Post-baseline Assessment|"The primary objective of the clinical study was to assess whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE).~The change was defined as: Total lymphocyte count at visit minus total lymphocyte count at baseline.~A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased.~The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect.~The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake.~End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12."|Baseline, Week 2, Week 4, Week 8, Week 12, end-of-treatment Visit (up to 12 weeks)|Pharmacodynamics analysis (PD) set. The PD set includes all participants who received at least 21 days of study treatment, with lymphocyte count measurements at baseline and post-baseline. Last observation carried forward (using the Week 4 visit or later) was used for participants with a missing end-of-treatment (EOT) assessment.|||10^9 cells/L||Standard Deviation|Mean
2575099|NCT02472522|Post-Hoc|Percentage of Patients Needing Rescue Analgesic|Percentage of patients needing rescue analgesic. Rescue analgesia was provided with 6 mg of intravenous morphine and additional doses of 3 mg at 10 minutes interval till VAS was less than 3 or the development of adverse effects such as nausea and/or vomiting, respiratory depression (SpO2 <92%, ventilatory frequency rate <10), or occurrence of deep sedation (eyes closed >3 min, Ramsay Score RS >2).|24 hours||||percentage needing rescue analgesic|||Number
2576133|NCT02454101|Secondary|Jundice Requring Phtotherapy|number of infants requiring phtotherapy for jundice in the first 2 weeks|two weks|Number of Infants Analyzed|||participants|||Number
2575084|NCT02472795|Primary|Change in Total Lymphocyte Count From Baseline to End-of-treatment (EOT)|"The primary objective of the clinical study was to asses whether cenerimod could reduce the number of circulating lymphocytes in the bloodstream of people with systemic lupus erythematosus (SLE).~The change was defined as: Total lymphocyte count at end-of-treatment (EOT) minus total lymphocyte count at baseline.~A negative change over time indicates that the number of peripheral circulating lymphocytes has decreased.~The reduction of the total lymphocyte count over a treatment period indicates a pharmacodynamic effect.~The value at baseline was defined as the last non-missing value obtained from a sample taken prior to the first study treatment intake.~End-of-treatment (EOT) was defined as the last post-baseline value with treatment for at least 21 days up to Week 12."|Baseline to end-of-treatment (EOT) (up to 12 weeks)|Pharmacodynamics analysis (PD) set. The PD set includes all participants who received at least 21 days of study treatment, with lymphocyte count measurements at baseline and post-baseline. Last observation carried forward (using the Week 4 visit or later) was used for participants with a missing end-of-treatment (EOT) assessment.|||10^9 cells/L||Standard Deviation|Mean
2575085|NCT02472756|Primary|Percentage of Participants Who Were Alive at Year 2||Year 2|ITT population.|||percentage of participants|||Number
2575086|NCT02472756|Primary|Percentage of Participants With Complete Remission (CR)|Lymphoma response was assessed using Cheson criteria. Criteria for CR (target lesions): Nodes returned to normal (if GTD >15 mm before therapy, GTD now ≤15 mm; if GTD 11-15 mm and SA >10 mm before therapy, SA now ≤ 10 mm) and all (non-nodal) target lesions completely resolved. Criteria for CR (non-target lesions): All non-target lymph nodes returned to normal size, all extra-nodal lesions have completely resolved, liver and spleen have returned to normal size (if enlarged at baseline).|Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)|ITT population. Number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
2575087|NCT02472756|Primary|Percentage of Participants With Objective Response|Lymphoma response was assessed using Cheson criteria. Objective response was defined as having either complete remission (CR) or partial remission (PR). Criteria for CR (target lesions): Nodes returned to normal (if greatest transverse diameter [GTD] greater than [>] 15 millimeters [mm] before therapy, GTD now less than or equal to [≤] 15 mm; if GTD 11-15 mm and short axis [SA] >10 mm before therapy, SA now ≤10 mm) and all (non-nodal) target lesions completely resolved. Criteria for CR (non-target lesions): All non-target lymph nodes returned to normal size, all extra-nodal lesions have completely resolved, liver and spleen have returned to normal size (if enlarged at baseline). Criteria for PR: Sum of the product of the diameters (SPD) of target lesions decreased at least 50 percent (%) from baseline and spleen and liver nodules regressed by 50% in SPD or single lesion in GTD.|Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)|Intent-to treat (ITT) population. Number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
2575088|NCT02472730|Secondary|Number of Colonoscopies During Which at Least One Polyp Was Identified|Proportion of colonoscopies that identify at least one polyp|Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program||||Participants|||Count of Participants
2575089|NCT02472730|Secondary|Number of Colonoscopies During Which at Least One Adenoma Was Identified|Proportion of colonoscopies that identify at least one adenoma|Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program||||Participants|||Count of Participants
2575090|NCT02472730|Secondary|Mean Time From the Moment of Colonoscope Insertion Until the Appendiceal Orifice or Ileocecal Valve is Identified|Time from the moment of colonoscope insertion until the appendiceal orifice or ileocecal valve is identified|Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program||||minutes||95% Confidence Interval|Mean
2575091|NCT02472730|Primary|Number of Participants That Successfully Reached the Cecum Within 30 Minutes of Insertion|Proportion of all colonoscopies in which the trainee successfully reached the cecum within 30 minutes of insertion without the help of the attending physician.|Each outcome measured during a complete colonoscopy. All colonoscopies performed during the initial 3 months of a 12 month training program||||Participants|||Count of Participants
2575092|NCT02472652|Secondary|Prolactin Concentrations ng/ml (Normal Range 4.0 - 15.2ng/ml)|Subjects enrolled in this study will be followed for an average of about 5 months. Serum prolactin concentrations will be measured to assess change from Baseline to Endpoint|Baseline and Endpoint average of about 5 months|Subject 2 not analyzed as lost to follow up|||ng/ml|||Number
2575093|NCT02472652|Primary|Change in Arizona Sexual Experiences Scale (ASEX) Score|Subjects enrolled in this study will be followed for an average of about 5 months. The ASEX will be done at screening to ensure subjects meet criteria for sexual dysfunction as defined by the scale. In addition subjects must remember at least a 2 point change in the scale since starting Invega Sustenna or Risperdal Consta. Subjects must also score no greater than or equal to 25 on the scale to ensure a baseline of minimal sexual activity. The primary outcome of the study is the change in ASEX score from Baseline to Endpoint. Total scores range from 5 - 30 with the higher scores indicating more sexual dysfunction.|Baseline and 12 weeks|Data no available for Subject 2 as lost to follow up|||units on a scale|||Number
2575094|NCT02472639|Secondary|Dehydration Related Hospital Admissions During Study Period|Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.|3 months|||||||
2575095|NCT02472639|Secondary|Score on Additional QOL Questions Not Included in Stoma-QoL Questionnaire|Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.|3 months|||||||
2575096|NCT02472639|Secondary|Number of Ostomy Bag Breakages During the Study Period|Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.|3 months|||||||
2575097|NCT02472639|Secondary|Overall Satisfaction With Ostom-i Device|Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.|3 months|||||||
2575098|NCT02472639|Primary|Patient Quality of Life as Measured by the 20-item Stoma-QOL Questionnaire at 1 Month and 3 Month Follow-up After Using the Ostomi-I Alert Versus Standard Stoma Care Without the Ostom-i Alert.||up to 3 Months|Study was prematurely terminated. Data was not collected or analyzed due to issue with study compliance.||||||
2615590|NCT01999192|Secondary|Clinical Disease Activity Index [CDAI] ≤10||week 12 & 24|||||||
2575102|NCT02472522|Other Pre-specified|Visual Analogue Scale at Rest (VAS-R)|Visual Analogue Scale at rest (VAS-R) was used to assess Post-operative Pain at rest. Where: 0 = no Pain and 10 = Worst Imaginable Pain. They were Recorded on Shifting to Postoperative and Then at 1, 4, 8, 12, 18 and 24 Hour|24 hours||||Units on a scale||Standard Deviation|Mean
2575103|NCT02472522|Other Pre-specified|Heart Rate: Postoperative|The Heart Rate of the patients were recorded after shifting from Operation Theater and at 1, 4, 8,12,18 and 24th hour after shifting to the postoperarive area.|24 hours||||beats/minute||Standard Deviation|Mean
2575104|NCT02472522|Other Pre-specified|Mean Arterial Pressure (MAP): Postoperative Period|The Mean Arterial Pressure (MAP) of the patients were recorded after shifting from Operation Theater and at 1, 4, 8,12,18 and 24th hour after shifting to the postoperarive area.|24 hours||||millimeter of mercury (mmHg)||Standard Deviation|Mean
2575105|NCT02472522|Other Pre-specified|Duration of Sensory Loss at T10 Level|The duration of sensory loss (from the subarachnoid block) at T10 level was assessed by pin-prick test by a sterile needle in minutes.|24 hours||||minutes||Standard Deviation|Mean
2575106|NCT02472522|Other Pre-specified|Time to Complete Disappearance of Motor Block|"During the postoperative recovery, the level of motor block was assessed with Modified Bromage Scale 0 = no paralysis, able to flex hips/knees/ankles~= able to move knees, unable to raise extended legs~= able to flex ankles, unable to flex knees~= unable to move any part of the lower limb The time from subarachnoid block to complete disappearance of motor block (Bromage 0) was recorded in minutes."|24 hours||||minutes||Standard Deviation|Mean
2575107|NCT02472522|Other Pre-specified|Heart Rate: Intraoperative Period|The Heart Rate of the patients were recorded from the start of surgery up to 60 minutes at 5, 10, 20, 30, 40, 50, 60 mins. No surgery lasted more than 60 minutes.|60 minutes||||beats/minute||Standard Deviation|Mean
2575108|NCT02472522|Other Pre-specified|Mean Arterial Pressure (MAP): Intraoperative Period|The Mean Arterial Pressure (MAP) of the patients were recorded from the start of surgery up to 60 minutes at 5, 10, 20, 30, 40, 50, 60 mins. No surgery lasted more than 60 minutes.|Upto 60 minutes||||millimeter of mercury (mmHg)||Standard Deviation|Mean
2575109|NCT02472522|Secondary|Adverse Effects Like Pruritus, Nausea and Vomiting||24 hours||||participants|||Number
2575110|NCT02472522|Secondary|Total Dose of Required Morphine in 24 Hours Postoperatively||24 hours|Only the mentioned number of patients needed analgesia within the first 24 hours postoperatively|||Milligrams||Standard Deviation|Mean
2575111|NCT02472522|Primary|The Time After the TAP Block When Rescue Analgesia Was First Sought||24 hours|Number of patients who sought rescue analgesic within the first 24 hours postoperatively. Rest of the studied patients needed no rescue analgesic within the first 24 hours postoperatively.|||Hours||Standard Deviation|Mean
2575112|NCT02472405|Primary|POSAS (The Patient and Observer Scar Assessment Scale) Measure|POSAS is a scale that contains the following parameters: pigmentation, vascularity, pliability, height, surface area, and patient input with regards to pain, itching, relief, stiffness, color and thickness. Both the patient and the observer are asked to give their Overall Opinion on the appearance of the scar. Again, a 10-point scale (ranging from 1 to 10) is used in which 10 corresponds to the worst imaginable scar.|2 months|The measurement used for this outcome was completed 4 weeks post final intervention, only eight participants completed the study protocol, but only 6 participant's POSAS score was collected. Observer's score for the POSAS is not available. Only the score for the participants was reported.|||Score||Standard Deviation|Mean
2575113|NCT02472366|Post-Hoc|Change in Best Corrected Visual Acuity From Baseline|A subgroup analysis was performed in which only pseudophakic subjects were included. Best Corrected Visual Acuity is measured using an ETDRS eye chart and is reported as the number of letters read correctly in the study and/or fellow eye.|Change from Baseline to 12 months post ILUVIEN administration|"For the Laser arm group, 6 patients were enrolled and 7 eyes were treated with ILUVIEN"|||Best Corrected VA Letter Score|Participants|Standard Deviation|Mean
2575114|NCT02472366|Secondary|Changes in Macular Volume||Change from Baseline to 12 months post ILUVIEN administration|"For laser arm group, 6 patients were enrolled with 7 eyes receiving ILUVIEN"|||mm^3|Participants|Standard Deviation|Mean
2575115|NCT02472366|Secondary|Changes in Central Subfield Thickness||Change from Baseline to 12 months post ILUVIEN administration|"For Laser arm group, there were 6 patients enrolled but 7 eyes treated"|||microns|Participants|Standard Deviation|Mean
2575116|NCT02472366|Secondary|Changes in Intraocular Pressure (IOP)||Change from Baseline to 12 months post ILUVIEN administration|"for laser arm group, 6 patients enrolled with 7 eyes receiving ILUVIEN"|||mmHg|Participants|Standard Deviation|Mean
2575117|NCT02472366|Primary|Changes in Best Corrected Visual Acuity From Baseline|Best Corrected Visual Acuity is measured using an ETDRS eye chart and is reported as the number of letters read correctly in the study and/or fellow eye.|Change from Baseline to 12 months post ILUVIEN administration|"For the Laser arm group, 6 patients were enrolled and 7 eyes were treated with ILUVIEN"|||Best Corrected VA Letter Score|Participants|Standard Deviation|Mean
2575118|NCT02472353|Primary|Number of Participants With Less Than or Equal to 5% Decrease in Left Ventricle Ejection Fraction (LVEF) on Echocardiogram|Determine whether the addition of metformin to standard doxorubicin therapy in breast cancer patients will decrease the incidence of change in left ventricle ejection fraction (LVEF).|1 year||||Participants|||Count of Participants
2575119|NCT02472314|Secondary|Incidence of Nerve Injury|Neuropraxia on the treatment side|During hospital stay and at 2 weeks and 6 weeks post-operatively||||Participants|||Count of Participants
2575120|NCT02472314|Secondary|Subjective Shoulder Value (SSV)|Functional assessments after shoulder arthroplasty surgery. The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. The range is between 0% and 100%|Pre-operative, 6 weeks and last Follow up||||score on a scale||Full Range|Mean
2575121|NCT02472314|Secondary|Post Operative American Shoulder and Elbow Surgeons (ASES)|American Shoulder and Elbow Surgeons (ASES) score is an outcome reporting measure for assessments of shoulder function in patients with shoulder pathology and after shoulder arthroplasty surgery. ASES is a 100 points scale consisting of two measures: one pain scale (worth 50 points) and 10 activities of daily living(worth 50 points), the total score is the sum of both and the higher total score indicates better outcome.|Preoperative, 6 weeks and last follow up||||score on a scale||Standard Deviation|Mean
2579895|NCT02412501|Secondary|Number of Participants With Stent Thrombosis (ST) at 24 Months Post Procedure||24 Months||||Participants|||Count of Participants
2575122|NCT02472314|Primary|Quality of Analgesia|Quality of analgesia as measured by numerical rating scores for pain (active and at rest) as (0=no pain, 10= worst pain) every two hours for the initial 36 hours, then on day2, day7 and day30 postoperatively|30 days||||score on a scale||Full Range|Mean
2575123|NCT02472262|Secondary|Association of 16S Configuration of Fecal Microbiome With Demographic, Anthropometric, Intestinal Permeability, Sanitation and Antibiotic Exposure Characteristics of the Study Population||6 months||2020-05-31|05/2020||||
2575124|NCT02472262|Secondary|Weight-for-height z Score at 9 and 12 Months of Age|weight for height z-score at 9 and 12 months of age|6 months||2020-05-31|05/2020||||
2575125|NCT02472262|Secondary|Mid-upper Arm Circumference at 9 and 12 Months of Age|Mid-upper arm circumference in cm|6 months||2020-05-31|05/2020||||
2575126|NCT02472262|Secondary|16S Configuration of Fecal Microbiota at 6.5, 7.5, 9, 10.5 and 12 Months of Age Comparing Supplementary Food Groups||6 months||2020-05-31|05/2020||||
2575127|NCT02472262|Primary|% Lactulose From Dual Sugar Absorption Test at 9 and 12 Months of Age|percent of lactulose found in urine during the dual sugar absorption test|6 month||2020-05-31|05/2020||||
2575128|NCT02472262|Primary|Change in Length-for-age z Score Over 6 Months From Enrollment to End of Study.|Change in length-for-age z score from enrollment to end of study 6 months|6 months||||z-score||95% Confidence Interval|Mean
2575129|NCT02472145|Secondary|Part B: Duration of Response (DOR) Based on Investigator Assessment|DOR defined as number of weeks from documented best response (CR or CRi) for participants who achieved CR or CRi to relapse, death due to relapse, date of censoring. As per modified IWG criteria: CR: Bone marrow blasts <5 %; absence of blasts with Auer rods; absence of extramedullary disease;absolute neutrophil count >1.0*10^9/L (1000/mcL); platelet count >100*10^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts <5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia <1.0* 10^9/L (1000/mcL) or thrombocytopenia <100*10^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis.|Approximately 2.5 years|Population included participants in ITT, who achieved CR or CRi.|||Weeks||95% Confidence Interval|Median
2575130|NCT02472145|Secondary|Part B: Time to Best Response|Time to best response is calculated as the time from the randomization date to the first documented date for the best response for participants who achieved CR or CRi, as per modified IWG criteria. CR: Bone marrow blasts less than (<)5 %; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (>)1.0 *10^9/liter (L) (1000/mcL); platelet count >100*10^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts <5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia <1.0*10^9/L (1000/mcL) or thrombocytopenia <100*10^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis.|Approximately 2.5 years|Population included participants in ITT, who achieved CR or CRi.|||Weeks||Full Range|Median
2575131|NCT02472145|Secondary|Part B: Percentage of Participants With Complete Response (CR) Plus Minimal Residual Disease (MRD) Negative Complete Response With Incomplete Recovery (CRi)|Percentage of participants who achieved CR plus MRD-negative CRi were reported. MRD negativity defined as <1 blast or leukemic stem cell in 10,000 leukocytes (MRD level <10^4).CR: Bone marrow blasts less than (<)5 percent (%); absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (>)1.0*10^9/liter (L) (1000/mcL); platelet count >100*10^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts <5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia <1.0*10^9/L (1000/mcL) or thrombocytopenia <100*10^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis.|Approximately 2.5 years|Population included participants in ITT, among whom MRD negativity was evaluated upon achieving response.|||Percentage of participants|||Number
2575132|NCT02472145|Secondary|Part B: Percentage of Participants Who Achieved CR and CRi (Overall Response Rate)|Percentage of participants who achieved CR and CRi, as per modified IWG criteria. CR: Bone marrow blasts less than (<)5 %; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (>)1.0 *10^9/liter (L) (1000/ mcL); platelet count >100 *10^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts <5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia <1.0*10^9/L (1000/mcL) or thrombocytopenia <100*10^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis.|Approximately up to 2.5 years|ITT population is defined as all randomized participants, grouped per treatment assigned by randomization, regardless of the actual treatment received.|||Percentage of Participants|||Number
2575133|NCT02472145|Secondary|Part B: Event-free Survival (EFS) Based on Investigator Assessment|EFS defined as time from randomization to treatment failure, relapse from CR/CRi, or death from any cause, whichever occurs first, per modified IWG criteria. Treatment failure: >25% absolute increase in the bone marrow blast count from baseline to present assessment (example, 20% to 46%) on bone marrow aspirate (or biopsy in case of dry tap); Relapse: Bone marrow blasts greater than equal to (>=)5%; reappearance of blasts in blood; or development of extramedullary disease; CR: Bone marrow blasts <5 %; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count > 1.0*10^9/L (1000/mcL); platelet count >100*10^9/L (100 000/mcL);independence of red cell transfusions; CRi: Bone marrow blasts <5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia <1.0*10^9/L (1000/mcL) or thrombocytopenia <100*10^9/L (100 000/mcL); independence of red cell transfusions. Endpoint reported is for Part B only as per planned analysis.|Approximately up to 2.5 years|ITT population defined as all randomized participants, grouped per treatment assigned by randomization, regardless of actual treatment received.|||Months||95% Confidence Interval|Median
2575134|NCT02472145|Primary|Part B: Overall Survival|Overall Survival (OS) was defined as the time from the date of randomization to date of death from any cause. Median Overall Survival was estimated by using the Kaplan-Meier method. This endpoint is reported here for Part B only as per the planned analysis.|Approximately up to 2.5 years|ITT population is defined as all randomized participants, grouped per treatment assigned by randomization, regardless of the actual treatment received.|||Months||95% Confidence Interval|Median
2575233|NCT02469961|Secondary|Total Narcotic Used by Each Participant|the use for morphine and/or fentanyl and or Demerol converted to morphine equivalents|Participants will be followed from the start of sedation until discharge: approximately 3-5 hr||||Microgram||Standard Deviation|Mean
2575135|NCT02472145|Primary|Part B: Percentage of Participants Who Achieved Complete Response (Complete Response Rate) Based on Investigator Assessment|Complete response rate defined as percentage of participants who achieved complete response as per modified International Working Group (IWG) criteria. CR: Bone marrow blasts less than (<)5 percent (%); absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (>)1.0*10^9/liter (L) (1000/micro liter [mcL]); platelet count >100*10^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis.|Approximately up to 2.5 years|Intent-to-Treat (ITT) population is defined as all randomized participants, grouped per treatment assigned by randomization, regardless of the actual treatment received.|||Percentage of participants|||Number
2575136|NCT02471755|Secondary|Change of E2 From Baseline|Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.|week8,week20||||pmol/l||Inter-Quartile Range|Median
2575137|NCT02471755|Secondary|Change of FSH/LH From Baseline|Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.|week8,week20||||ratio||Inter-Quartile Range|Median
2575138|NCT02471755|Secondary|Change of LH From Baseline|Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.|week8,week20||||mIU/ml||Inter-Quartile Range|Median
2575139|NCT02471755|Secondary|Change of FSH From Baseline|Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.|week8,week20||||mIU/ml||Inter-Quartile Range|Median
2575140|NCT02471755|Secondary|Change of MRS (Menopause Rating Scale) From Baseline|MRS(Menopause Rating Scale) was designed to measure MT symptoms and to explore the influences on life qualities in a standardized way. In MRS, symptoms such as impaired memory, depression, insomnia, sweating, hot flashes, nervousness, joints complaints, lack of concentration were evaluated and calculated in numbers to describe the situation of patient. Scores on MRS range from 0 to 44, with higher scores indicating more severe symptoms.|week8;wee4,20,32||||Scores on a scale||Inter-Quartile Range|Median
2575141|NCT02471755|Primary|Change of Average 24 h Hot Flash Score From Baseline|Every day during the 4th, 8th, 20th, and 32nd weeks, symptoms and specific times of hot flashes were recorded in hot flash diaries by the participants.Data from weeks 4, 20 and 32 were recorded as the second time frame.According to the severity categories suggested by Food and Drug Administration (FDA), hot flashes were assessed as mild, moderate, or severe. Hot flash scores are calculated as (hot flash frequency x severity)/7, with severity scores ranging from 1=mild 2=moderate to 3=severe.|week8;wee4,20,32||||Scores on a scale||Inter-Quartile Range|Median
2575142|NCT02471651|Secondary|Total Number of Treatments in Each Arm Between Baseline and 9 Months|Total number of treatments in each arm between baseline and 9 months.|baseline and 9 months||||injections|||Number
2575143|NCT02471651|Secondary|Mean Change in Standardized Best-corrected Visual Acuity (BCVA) Between Baseline and 9 Months|Mean change in standardized best-corrected visual acuity between baseline and 9 months as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) testing. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified|baseline and 9 months||||letters on the ETDRS scale||Standard Deviation|Mean
2575144|NCT02471651|Primary|Mean Change in Central 1 mm Subfield Thickness Between Baseline and 9 Months|Mean change in central 1 mm sub-field thickness between baseline and 9 months as measured by Spectral Domain Optical Coherence Tomography (SDOCT).|baseline and 9 months||||millimeters||Standard Deviation|Mean
2575145|NCT02471612|Secondary|Patients Needing Re-exploration|Number of patients needing return to the operation theater for surgery for the same pathology or any other complication arising out of the initial surgery|30 days||||participants|||Number
2575146|NCT02471612|Secondary|Number of Participants With Acute Kidney Injury (AKI)|"Acute Kidney Injury (AKI) was diagnosed based on the Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group (2012) guidelines~Increase in Serum Creatinine (S. Cr) by ≥0.3 mg/dl (≥ 26.5 μmol/l) within 48 hours; OR~Increase in S. Cr to ≥1.5 times baseline, which is known or presumed to have occurred within prior 7 days; OR~Urine volume <0.5 ml/kg/h for 6 hours"|30 days||||participants|||Number
2575147|NCT02471612|Secondary|Cardiac Morbidity (AMI or Arrhythmias Needing Treatment)|Number of patients noted to have Cardiac morbidity: Acute myocardial infarction (AMI) or arrhythmias needing treatment|30 days||||participants|||Number
2575148|NCT02471612|Secondary|Need for Post Operative Inotropic Support|Number of patients needing post-operative inotropic support|30 days||||participants|||Number
2575149|NCT02471612|Secondary|Need for Postoperative Ventilator Support|Number of patients needing post-operative ventilatory support|30 days||||participants|||Number
2575150|NCT02471612|Secondary|Length of Stay (LOS)|The mean duration of hospital stay or Length of Stay was recorded|30 days||||Days||Standard Deviation|Mean
2575165|NCT02471183|Secondary|Percentage of Patients With Change in 6-minute Walk Distance (6MWD)|"Percentage of patients with an increase (> 8% of baseline), maintenance (+/- 8% of baseline), or decrease (< -8% of baseline) in their 6MWD (at trough) from baseline to Week 16. The ± 8% boundaries for change in 6MWD reflect the approximately 8% coefficient of variation in the reproducibility of the 6MWD.~The trough level of inhaled treprostinil is defined as the last dose having been taken not less than 4 hours and not more than 48 hours prior to the 6MWD test at Visit 1 (screening). The trough level of selexipag was defined as the last dose having been taken not less than 8 hours and not more than 7 days prior to the 6MWD test at Visit 5 (Week 16)."|Baseline and Week 16||||Percentage of participants|||Number
2579896|NCT02412501|Secondary|Number of Participants With Target Vessel Failure (TVF) at 24 Months Post Procedure||24 Months||||Participants|||Count of Participants
2575151|NCT02471612|Primary|Area Under the Receiver Operating Curve (ROC) as a Measure of the Accuracy of the APACHE II and P-POSSUM Scoring Systems to Predict Mortality|"Participants will be followed for the duration of hospital stay (expected average of 30 days) and mortality was noted.All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with APACHE II and P-POSSUM scoring systems on the day of surgery. Area under the curve (AUC) is used to measure the size of the prediction composed by the graphic display between the 'sensitivity' and the '1-specificity' relationship. AUC can range from 0.5 to 1.0 and a result of 1.0 indicates a perfect discriminatory ability. An AUC value > 0.8 is considered good, a range between 0.60-0.80 is considered as moderate, and an AUC value < 0.60 is regarded as poor. For APACHE-II, a cut off score of >/=24 was determined; for P-POSSUM, a cut off score of >/= 63 was determined."|30 days|All patients undergoing emergency laparotomy at Tata Main Hospital form December 2013 to November 2014 were scored with APACHE II & P-POSSUM scoring systems on the day of surgery. The patients were followed up till at least 30 days after discharge or death (during admission or within 30 days after discharge).|||probability of accurate prediction||95% Confidence Interval|Number
2575152|NCT02471521|Secondary|Diagnostic Method That Detects Gastric Insufflation First||Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec||||Participants|||Count of Participants
2575153|NCT02471521|Primary|Inspiratory Pressure That Cause Gastric Insufflation|"Difference in the inspiratory pressure that minimized the incidence of gastric insufflation, yet guaranteed a tidal volume of at least 6 ml/kg between the neuromuscular blocker and non-neuromuscular blocker groups.~Gastric insufflation was measured using both gastric ultrasonography and epigastric auscultation."|Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec||||cmH2O||Full Range|Mean
2575154|NCT02471404|Secondary|Number of Patients Rescued|Number (%) of patients rescued.|Over the 52 week treatment period||||Percentage of participants|||Number
2575155|NCT02471404|Secondary|Time to Rescue|The time to rescue (from first dose date after randomisation to start of rescue medication or discontinuation due to lack of glycaemic control) during the 52 week double blind treatment period|Over the 52 week treatment period||||Weeks||95% Confidence Interval|Median
2575156|NCT02471404|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 52|Change in FPG from baseline (week 0) to week 52|Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis|Full Analysis Set|||FPG (mmol/L)||Standard Error|Least Squares Mean
2575157|NCT02471404|Secondary|Change in Total Body Weight From Baseline at Week 52|Change in body weight from baseline (week 0) to week 52|Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis||||Weight (kg)||Standard Error|Least Squares Mean
2575158|NCT02471404|Secondary|Patients With at Least One Episode of Confirmed Hypoglycaemia|Percentage of patients reporting at least 1 episode of hypoglycaemia (symptomatic + blood glucose <=50 mg/dL) during the double-blind treatment period|Up to Week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis|Full Analysis Set|||Percentage of participants|||Number
2575159|NCT02471404|Primary|Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52|Change in HbA1c from baseline (week 0) to week 52.|Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis|Full Analysis Set|||HbA1c %||Standard Error|Least Squares Mean
2575160|NCT02471326|Secondary|Subjects Who Met Criteria to Restart Antiretroviral Therapy|The secondary endpoint was the number of subjects who met protocol defined virologic (sustained HIV RNA >1000 copies/mL by Abbott HIV RTPCR at 2 consecutive visits), immunologic (a confirmed >30% decline in CD4 cell count or an absolute CD4 cell count < 350 cells/mm3), or clinical criteria (HIV-related symptoms) to discontinue VRC01 infusions and restart Antiretroviral Therapy (ART).|From Day 3 post initial infusion until up to 28 weeks.|The analyses included all subjects who received at least one infusion of VRC-HIVMAB060-00-AB (VRCO1).|||Participants|||Count of Participants
2575161|NCT02471326|Primary|Number of Grade 3 or Higher Adverse Events|The primary endpoint was the number of grade 3 or higher adverse events, including serious adverse events, that were possibly related to VRC-HIVMAB060-00-AB (VRCO1).|From the start of the initial infusion until up to 48 weeks.|The analyses included all subjects who received at least one infusion of VRC-HIVMAB060-00-AB (VRCO1).|||Events|||Number
2575162|NCT02471313|Primary|Number of Participants for Which Uptake of [18F]-FMISO Was Successful and Hypoxic Tumors Were Observed During PET Scan Imaging Post TACE Procedure|A single dose of study imaging agent [18F] FMISO was administered following the TACE procedure. PET Scan imaging was then performed to evaluate if hypoxic tumor identification were observable following administration of study imaging agent. Power and significance calculations are not applicable to this small sample feasibility study.|up to 72 hours after injection of [18F] FMISO||||Participants|||Count of Participants
2575163|NCT02471183|Other Pre-specified|Change From Baseline to Week 16 in the Treatment Satisfaction Questionnaire for Medication Questionnaire (TSQM II)|"The Treatment Satisfaction Questionnaire for Medication, Version II (TSQM II) is a validated tool that evaluate the subject's satisfaction with the study treatment. It includes a total of 11 questions related to satisfaction with treatment effectiveness, side effects,convenience, and global satisfaction.~TSQM scores range from 0 to 100 for each domain; a higher score indicates higher satisfaction with treatment."|Baseline and Week 16||||Units on a scale||95% Confidence Interval|Median
2575164|NCT02471183|Secondary|Geometric Mean of the Ratio in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) of Week 16 to Baseline|Changes in NT-proBNP levels in plasma are expressed by the geometric mean of the ratio of Week 16 to baseline|Baseline and Week 16||||Geometric mean of the ratio||95% Confidence Interval|Geometric Mean
2575181|NCT02470806|Secondary|Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period|Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.|Baseline through 12 weeks|Change in wound volume over 12-week treatment period by treatment group (PP population - all wounds)|||cm^3||Standard Deviation|Mean
2575166|NCT02471183|Secondary|Absolute Change in 6-minute Walk Distance (6MWD) at Trough|"The 6MWT is a non-encouraged test, which measures the distance (in meters) covered by the subject during a 6-minute walk. It is performed in a 30-meters long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed.~Absolute change from baseline to Week 16 in 6MWD is measured at trough levels of inhaled treprostinil and/or selexipag. The trough level of inhaled treprostinil is defined as the last dose having been taken not less than 4 hours and not more than 48 hours prior to the 6MWT at Visit 1 (screening). The trough level of selexipag was defined as the last dose having been taken not less than 8 hours and not more than 7 days prior to the 6MWT at Visit 5 (Week 16)."|Baseline and Week 16||||meters||95% Confidence Interval|Median
2575167|NCT02471183|Secondary|Percentage of Subjects With WHO Functional Class (FC) Change From Baseline|"The World Health Organization (WHO) defines 4 classes to classify the functional status of patients with pulmonary hypertension:~Class I (FC I): No limitation of physical activity. Class II (FC II): Slight limitation of physical activity. Class III (FC III): Marked limitation of physical activity. Class IV (FC IV): Inability to carry out any physical activity without symptoms.~Number of patients with improvement (shift from a higher to a lower class), worsening (shift from a lower to a higher class) or no change in WHO functional class at end of study compared to baseline are determined."|Baseline and Week 16||||percentage of participants|||Number
2575168|NCT02471183|Primary|Time to Discontinuation of Inhaled Treprostinil.|Median time from baseline (Day1) to the end of down-titration of inhaled treprostinil is calculated|Baseline to Week 16|All subjects who took at least one dose of selexipag were included in the safety analyses|||weeks||Full Range|Median
2575169|NCT02471183|Primary|Maximal Tolerated Dose|"This is the individual maximal tolerated dose (MTD) observed at Week 12 in the subjects still on selexipag at Week 16.~MTD is defined as the dose of selexipag reached with the last dose change up to Week 12"|At Week 12, in subjects still on selexipag at Week 16|Sensitivity analysis: only patients being on selexipag at week 16 are considered.|||mcg||Full Range|Median
2575170|NCT02471183|Primary|Absolute Change From Baseline Over Time in Heart Rate (HR)|Pulse rate is measured after at least 5 minutes of rest in a sitting position. Median change from baseline to pre-specified post-baseline visits are calculated.|Baseline, Week 4, Week 12, Week 16|All subjects who took at least one dose of selexipag were included in the safety analyses|||beats per minute (bpm)||Full Range|Median
2575171|NCT02471183|Primary|Absolute Change From Baseline Over Time in Blood Pressure|Both systolic(SBP) and diastolic (DBP) arterial blood pressure were measured in a sitting position after at least 5 minutes of rest at scheduled time points. Median change from baseline to pre-specified post-baseline visits are calculated|Baseline, Week 4, Week 12, Week 16|All subjects who took at least one dose of selexipag were included in the safety analyses|||mmHg||Full Range|Median
2575172|NCT02471183|Primary|Number of Subjects With Adverse Events Leading to Premature Discontinuation of Selexipag|Number of subjects with adverse events leading to premature discontinuation of selexipag is determined from the first dose of selexipag up to the last dose of selexipag|Up to 22 weeks on average|All subjects who took at least one dose of selexipag were included in the safety analyses|||Participants|||Count of Participants
2575173|NCT02471183|Primary|Percentage of Subjects With Treatment-emergent Adverse Events (AEs),|Percentage of subjects with treatment-emergent AEs (serious and non serious), regardless of relationship to selexipag|26 weeks on average (from the first dose of selexipag up to 30 days after the last dose of selexipag)|All subjects who took at least one dose of selexipag were included in the safety analyses|||Percentage of participants|||Number
2575174|NCT02471183|Primary|Percentage of Subjects With Sustained Treatment Transition|"A sustained treatment transition is considered if the 3 following criteria are met a) being on study treatment (selexipag) at Week 16, and b) not having a study treatment interruption(s) of a total of 8 days or more prior to Week 16, and c) absence of inhaled treprostinil or any prostanoid treatment after Week 8 up to Week 16.~The percentage of subjects with a sustained treatment transition is calculated with 95% confidence interval (CI) using the Clopper-Pearson method."|At Week 16|All subjects who took at least one dose of selexipag were included in the safety analyses|||Percentage of participants||95% Confidence Interval|Number
2575175|NCT02470949|Primary|Percent of Calories Consumed Following the Experimental Manipulation|The participants will be provided with an ad libitum lunch for 30 minutes following the completion of their manipulated social status condition.|Administered 30 days apart||||percent||Standard Deviation|Mean
2575176|NCT02470949|Primary|The Macronutrient Composition of Foods Consumed|The participants will be provided with an ad libitum lunch for 30 minutes following the completion of their manipulated social status condition.|Administered 30 days apart||||grams||Standard Deviation|Mean
2575177|NCT02470949|Primary|Calories Consumed Following the Experimental Manipulation|The participants will be provided with an ad libitum lunch for 20 minutes following the completion of their manipulated social status condition.|Administered 30 days apart||||kcal||Standard Deviation|Mean
2575178|NCT02470910|Secondary|Comparison of Bladder Volume Receiving 70 Gy or More With CT Versus MRI-planned Prostate Radiotherapy.|The volume of bladder receiving or exceeding 70 Gy will be calculated from the dose-volume histogram. Results will be compared for CT and MRI-based plans.|within 1 year of MRI examination||||cubic centimeters||Inter-Quartile Range|Median
2575179|NCT02470910|Primary|Comparison of Rectal Volume Receiving 70 Gy or More With CT Versus MRI-planned Prostate Radiotherapy.|The volume of rectum receiving or exceeding 70 Gy will be calculated from the dose-volume histogram. Results will be compared for CT and MRI-based plans.|within 1 year of MRI examination||||cubic centimeters||Inter-Quartile Range|Median
2575180|NCT02470806|Secondary|Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period|Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.|Baseline through 12 weeks|Percentage change in wound depth and volume over 12-week treatment period by treatment group (PP population - all wounds)|||percent change||Standard Deviation|Mean
2575487|NCT02466230|Other Pre-specified|Fractional Anisotropy Measured by Diffusion Tensor Imaging|Percent change in medial prefrontal average fractional anisotropy|Baseline to immediately after the final rTMS treatment (5 weeks)|||||||
2575182|NCT02470806|Secondary|Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period|Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.|Baseline through 12 weeks|Change in wound depth over 12-week treatment period by treatment group (PP population - all wounds)|||mm||Standard Deviation|Mean
2575183|NCT02470806|Primary|Percentage Change in Ulcer Area From Baseline to the End of the Treatment Period|Ulcer area was photographed in order to determine the measurements of the postdebridement ulcer area (cm^2 and total percentage [%]) using the ARANZ Silhouette wound imaging and measurement device.|Baseline through 12 weeks|The Per-Protocol (PP) population was used to analyze outcome measure data and included all subjects who were randomized, met inclusion/exclusion criteria, had not discontinued treatment within the first 9 weeks (-1 day), and had no significant protocol deviations.|||Percentage of change in wound area||Standard Deviation|Mean
2575184|NCT02470806|Primary|Change in Ulcer Area From Baseline to the End of the Treatment Period|Ulcer area was photographed in order to determine the measurements of the post-debridement ulcer area (cm^2 and total percentage [%]) using the ARANZ Silhouette wound imaging and measurement device.|Baseline through 12 weeks|The Per-Protocol (PP) population was used to analyze outcome measure data and included all subjects who were randomized, met inclusion/exclusion criteria, had not discontinued treatment within the first 9 weeks (-1 day), and had no significant protocol deviations.|||cm^2||Standard Deviation|Mean
2575185|NCT02470754|Other Pre-specified|Standardized Session: Half-life|Estimated Time (min) to reduce the plasma nicotine concentration by half based on observed pharmacokinetics.|Inpatient Day 1, Up to 4 Hours post Session|Pod Users Excluded|||min||Standard Deviation|Mean
2575186|NCT02470754|Secondary|Standardized Session: QSU Factor 2 (Smoking)|Questionnaire for Smoking Urges Brief measures urge to smoke.Two factor scores and a total score were derived. Factor 1 represents the desire and intention to smoke with smoking perceived as rewarding, while Factor 2 represents an anticipation of relief from negative effect with an urgent desire to smoke. Scores range from 5 to 35 with higher scores indicating a higher level of craving.|Inpatient Day 1, Up to 4 Hours post Session|Pod Users Excluded|||score on a scale||Standard Deviation|Mean
2575187|NCT02470754|Secondary|Standardized Session: QSU Factor 1 (Smoking)|Questionnaire for Smoking Urges Brief measures urge to smoke.Two factor scores and a total score were derived. Factor 1 represents the desire and intention to smoke with smoking perceived as rewarding, while Factor 2 represents an anticipation of relief from negative effect with an urgent desire to smoke. Scores range from 5 to 35 with higher scores indicating a higher level of craving.|Inpatient Day 1, Up to 4 Hours post Session|Pod Users Excluded|||score on a scale||Standard Deviation|Mean
2575188|NCT02470754|Secondary|Standardized Session: QSU Factor 2 (Vaping)|Questionnaire for Smoking Urges Brief modified for e-cigarettes to measure urge to vape.Two factor scores and a total score were derived. Factor 1 represents the desire and intention to smoke with smoking perceived as rewarding, while Factor 2 represents an anticipation of relief from negative effect with an urgent desire to smoke. Scores range from 5 to 35 with higher scores indicating a higher level of craving.|Inpatient Day 1, Up to 4 Hours post Session|Pod Users Excluded|||score on a scale||Standard Deviation|Mean
2575189|NCT02470754|Secondary|Standardized Session: Minnesota Nicotine Withdrawal Scale|Minnesota Nicotine Withdrawal Scale (MNWS) is a Self-Report Scale for measuring the severity of nicotine withdrawal symptoms.The possible range of scores for the 12-Item MNWS is between 0 and 48 with higher scores indicated greater withdrawal symptom severity.|Inpatient Day 1, Up to 4 Hours post Session|Pod Users Excluded|||score on a scale||Standard Deviation|Mean
2575190|NCT02470754|Secondary|Standardized Session: Positive and Negative Affect Score (Negative Affect)|The PANAS Scale or Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire. PANAS, (Sandín et al., 1999; Watson, Clark & Tellegen, 1988).This instrument is composed of 20 items: 10 items measuring positive affective states and 10 items measuring negative affect states.This subscale measures a person's negative emotions. Scores range from 10- 50 with higher scores indicating stronger negative feelings.|Inpatient Day 1, Up to 4 Hours post Session||||score on a scale||Standard Deviation|Mean
2575191|NCT02470754|Secondary|Standardized Session: QSU Factor 1 (Vaping)|Questionnaire for Smoking Urges Brief modified for e-cigarettes to measure urge to vape.Two factor scores and a total score were derived. Factor 1 represents the desire and intention to smoke with smoking perceived as rewarding, while Factor 2 represents an anticipation of relief from negative effect with an urgent desire to smoke.Scores range from 5 to 35 with higher scores indicating a higher level of craving.|Inpatient Day 1, Up to 4 Hours post Session||||score on a scale||Standard Deviation|Mean
2575192|NCT02470754|Primary|PK-estimated Nicotine Dose|Estimated in dose received (in milligrams) during the Standardized Session.|Inpatient Day 1, Up to 4 Hours post Session|Pod Users Excluded|||mg||Standard Deviation|Mean
2575193|NCT02470754|Primary|Standardized Session: AUC 0-240|Plasma Nicotine area-under-the curve from 0 to 4 Hours (ng/ml min)|Inpatient Day 1, Up to 4 Hours post Session|Pod users excluded|||(ng/ml min)||Standard Deviation|Mean
2575194|NCT02470754|Primary|Standardized Session: TMax|Time (min) when Max Plasma Nicotine Concentration was achieved|Inpatient Day 1, Up to 4 Hours post Session|Pod users excluded|||min||Standard Deviation|Mean
2575195|NCT02470754|Primary|Standardized Session:CMax|Maximum Plasma Nicotine Concentration (Cmax) (ng/mL)|Inpatient Day 1, Up to 4 Hours post Nicotine Administration|Pod users excluded|||ng/mL||Standard Deviation|Mean
2575196|NCT02470741|Primary|Changes in Fibroid-related Symptoms After Treatment With Letrozole|"The Uterine Fibroid Sympton and Quality of Life (UFS-QoL) Symptom Severity score measures self-reported severity of fibroid-related symptoms. Symptoms include: fatigue, sleep, self-image, mood disturbances/psychologic distress, fear of embarrassment, interference with daily activities, relationships with family and friends, and sexual functioning.~Scores range from 0 to 100; higher scores indicate greater symptom severity."|Baseline to 2 Months|The final analysis excludes one participant in the placebo/letrozole group who dropped out of the study after baseline but prior to starting study medication and the Month 2 visit.|||units on a scale||95% Confidence Interval|Least Squares Mean
2575488|NCT02466230|Other Pre-specified|Cortical Thickness Measured by T1 Magnetic Resonance Imaging|Percent change in medial prefrontal average cortical thickness|Baseline to immediately after the final rTMS treatment (5 weeks)|||||||
2575197|NCT02470494|Other Pre-specified|Adverse Events|All adverse events will be recorded on case report forms and determinations will be made as to the whether the events are Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects and/or related to the investigational device or the procedure.|Baseline and up to 90-day.||||Participants|||Count of Participants
2575198|NCT02470494|Secondary|Change in Subject's Self-Perceived Ability to Communicate.|The change in the subject's self-perceived ability to communicate with the use of the EarLens Device (CHD) when compared to baseline condition was measured using the validated Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. The APHAB produces scores for 4 subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV), which all range from 0-99%. A global score is computed by averaging the EC, RV, and BN subscores. For an individual score (either unaided alone or aided alone), a higher number indicates poorer performance, or more difficulty experienced. For this outcome measure, the difference between the average of the global unaided and aided scores is computed to determine the reduction (if any) in self-perceived difficulty, so a larger number in this outcome measure indicates better performance, as more of the difficulty has been reduced from the unaided condition by going to the aided condition.|Baseline and up to 90-day.|40 subjects available for analysis between enrollment/treatment and 90-day measurement.|||percentage of perceived benefit||Standard Deviation|Mean
2575199|NCT02470494|Secondary|Change in Functional Gain Over the Frequency Range From 2000 to 10,000 Hz.|10 dB (decibel) change in the average pure tone thresholds for the subject population over the frequency range from 2000 to 10,000 Hz (2000, 3000, 4000, 6000, 8000, and 10,000 Hz). Measurement to be used in analysis are the baseline unaided soundfield (SF) thresholds measured prior to device placement and the aided soundfield thresholds measured 90-day post placement. Analysis includes calculation of the unaided soundfield thresholds minus aided soundfield thresholds|Baseline and up to 90-day.|40 subjects available for analysis between enrollment/treatment and 90-day measurement.|||dB difference in SF Hearing Thresholds||Standard Deviation|Mean
2575200|NCT02470494|Secondary|Change in Speech Understanding in Noise.|"The change in aided speech reception thresholds (SRTs) when compared to the baseline unaided condition was measured using a validated speech test, the HINT 90.~Change in aided HINT 90 SRTs when compared to the baseline unaided condition. SRTs will be measured using HINT materials with the signal (speech level presented from 0 degrees) adapted relative to the noise (presented from 90 degrees held fixed at 60 dB SPL) to determine the signal-to-noise ratio for reporting the whole sentence correct 50% of the time (Nilsson et al., 1994). An improvement in HINT score is indicated as a negative (-) dB value change. A more negative value indicating an improvement of understanding speech and noise. An improvement of -1dB is equivalent to a 10% improvement in understanding speech and noise and is likely of clinical benefit. HINT 90 will be measured twice and averaged to obtain the per subject HINT SRT. All subject data will be averaged to obtain the means."|Baseline and up to 90-day.|28 subjects available for analysis between enrollment/treatment and 90-day measurement.|||dB difference in HINT scores||Standard Deviation|Mean
2575201|NCT02470494|Primary|Change in Hearing Stability Using Unaided Air Conduction Thresholds.|"Hearing sensitivity was monitored using earphones with the TMT (Tympanic Membrane Transducer) in place, but with the audio processor removed. Baseline and study end measurements were compared. A PTA4 (Pure Tone Average at 4 frequencies; 500, 1000, 2000 and 4000 Hz) was computed both for baseline unaided hearing post-placement with TMT in place, and unaided hearing with TMT in place at the 90-day for each ear, then averaged across both ears for each subject. A determination of No Hearing Change for the subject was made if the calculated hearing changes of the subject population are 10dB or less."|Baseline and up to 90-day.|40 subjects available for analysis between enrollment and 90-day measurement.|||dB difference in Unaided Hearing||Standard Deviation|Mean
2575202|NCT02470429|Secondary|Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42|TFBUT is defined as the time elapsed from the last blink until 1 or more dry spots appeared in the precorneal tear film. A longer tear film break-up time indicates a more stable tear film and may lead to improvement in dry eye symptoms. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 42|ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.|||seconds||Standard Error|Least Squares Mean
2575203|NCT02470429|Secondary|Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42|The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother.|Baseline (Day 0), Day 42|ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.|||units on a scale||Standard Error|Least Squares Mean
2575204|NCT02470429|Secondary|Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42|The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother.|Baseline (Day 0), Day 42|ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.|||units on a scale||Standard Error|Least Squares Mean
2575205|NCT02470429|Primary|Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42|The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded 3 areas of the ocular surface for dryness on a scale from 0 to 5, where 0=Absent and 5=Severe. The 3 scores were summed for a resultant overall 0-15 score. A more negative change value indicates greater efficacy. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 42|ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.|||units on a scale||Standard Error|Least Squares Mean
2575206|NCT02470403|Secondary|The Apparent Volume of Distribution of LIK066 During the Terminal Elimination Phase Following Extra Vascular Administration (Vz/F) in Part 2 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Vz/F at steady state (Vz/F, ss)|Day 1, Day 14|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||Liter||Standard Deviation|Mean
2575219|NCT02470403|Primary|Part 2: Number of Patients With Any Adverse Events, Serious Adverse Events and Death|This endpoint reports patients with at least one AE (any AE), serious AE and death|2 weeks|The safety analysis set included all subjects that received any study drug.|||Patients|||Number
2575207|NCT02470403|Secondary|The Apparent Systemic Clearance at Steady State (CLss/F) of LIK066 Following Extra Vascular Administration in Part 2 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports CLss/F at steady state (CLss/F, ss)|Day 1, Day 14|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||Liter/hour||Standard Deviation|Mean
2575208|NCT02470403|Secondary|Area Under the Plasma Concentration-time Profile to the Time of Next Dosing (AUCtau) of LIK066 in Part 2 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. Day 14 data reports AUCtau at steady state (AUCtau, ss)|Day 1, Day 14|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||hr*ng/mL||Standard Deviation|Mean
2575209|NCT02470403|Secondary|Area Under the Plasma Concentration-time Profile to the Time of the Last Quantifiable Concentration (AUClast) of LIK066 in Part 2 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation. Day 14 data reports AUClast at steady state (AUClast, ss)|Day 1, Day 14|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||hr*ng/mL||Standard Deviation|Mean
2575210|NCT02470403|Secondary|Time to Maximum Plasma Concentration of LIK066 (Tmax) in Part 2 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Tmax at steady state (Tmax, ss)|Day 1, Day 14|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||hour||Full Range|Median
2575211|NCT02470403|Secondary|Maximum Plasma Concentration of LIK066 (Cmax) in Part 2 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 9 h post-dose on Day 1 and 14. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. Day 14 data reports Cmax at steady state (Cmax, ss)|Day 1, Day 14|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||ng/mL||Standard Deviation|Mean
2575212|NCT02470403|Secondary|The Apparent Volume of Distribution of LIK066 During the Terminal Elimination Phase Following Extra Vascular Administration at Steady State (Vz/F, ss) in Part 1 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.|Day 84|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||Liter||Standard Deviation|Mean
2575213|NCT02470403|Secondary|The Apparent Systemic Clearance at Steady State (CLss/F, ss) of LIK066 Following Extra Vascular Administration in Part 1 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.|Day 84|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||Liter/hour||Standard Deviation|Mean
2575214|NCT02470403|Secondary|Area Under the Plasma Concentration-time Profile to the Time of Next Dosing at Steady State (AUCtau, ss) of LIK066 in Part 1 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation.|Day 84|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||hr*ng/mL||Standard Deviation|Mean
2575215|NCT02470403|Secondary|Area Under the Plasma Concentration-time Profile to the Time of the Last Quantifiable Concentration at Steady State (AUClast, ss) of LIK066 in Part 1 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects. The linear trapezoidal rule was used for AUC calculation.|Day 84|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||hr*ng/mL||Standard Deviation|Mean
2575216|NCT02470403|Secondary|Time to Maximum Plasma Concentration of LIK066 at Steady State (Tmax, ss) in Part 1 of the Study|Blood samples were collected at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h post-dose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.|Day 84|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||hour||Full Range|Median
2575217|NCT02470403|Secondary|Maximum Plasma Concentration of LIK066 at Steady State (Cmax ss) in Part 1 of the Study|Blood samples were collected at predose, 0.5, 1, 1.5, 2, 3, 4, 6 and 24 h postdose on Day 84. Overall glycemic status represents combination of dysglycemic and normoglycemic subjects.|Day 84|The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data.|||ng/mL||Standard Deviation|Mean
2575218|NCT02470403|Secondary|Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14) in LIK066 Twice Daily and LIK066 Three Times Daily Arms|"Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Baseline is defined as Day 1 predose.~Percent change is calculated as [(post baseline- Baseline) /Baseline] * 100. A longitudinal mixed effects model for percent change in body weight was used.~The longitudinal mixed effects model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by-time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, the treatment-by-time-by-glycemic status interaction, a random effect for study part and baseline body weight as a covariate."|Baseline, Week 2|The pharmacodynamics (PD) analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. The analysis is based on all subjects with a Baseline body weight and at least one post-Baseline body weight measurement.|||percent change||80% Confidence Interval|Least Squares Mean
2576134|NCT02454101|Primary|Neonatal Hemoglobin Level|neonatal 6 weeks hemoglobin measured in gram %|6 weeks after labor|Number of Infants Analyzed|||gram%||Standard Deviation|Mean
2575220|NCT02470403|Primary|Part 1 and Part 2: Percent Change in Body Weight From Baseline to Week 2 (Day 14)|"Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Part 1: Baseline is defined as Day -1. Part 2: Baseline is defined as Day 1 predose.~Percent change is calculated as [(post baseline- Baseline) /Baseline] * 100. A longitudinal mixed effects model for percent change in body weight was used.~The longitudinal mixed effects model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by-time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, the treatment-by-time-by-glycemic status interaction, a random effect for study part and baseline body weight as a covariate."|Baseline, Week 2 (Day 14)|Pharmacodynamic set. The analysis was based on all subjects with a baseline body weight and at least one post-Baseline body weight measurement. Only data from common time points in Part 1 and Part 2 were included in the analysis, i.e., Baseline and Day 14.|||Percent change||80% Confidence Interval|Least Squares Mean
2575221|NCT02470403|Primary|Part 1: Number of Patients With Any Adverse Events, Serious Adverse Events and Death|This endpoint reports patients with at least one AE (any AE), serious AE and death.|12 weeks|The safety analysis set included all subjects that received any study drug.|||Patients|||Number
2575222|NCT02470403|Primary|Part 1: Percent Change in Body Weight From Baseline to Week 12|"Triplicate body weight measurements at each visit were averaged and represented body weight at that visit. Baseline was defined to be the body weight at the last visit prior to the first treatment. Baseline is Day -1 in Part 1. Percent change is calculated as [(post baseline- Baseline) /Baseline] * 100.~A longitudinal mixed effects model for percent change in body weight was used. The model included fixed effects of treatment, time, glycemic status (a stratification factor for randomization), the treatment-by- time interaction, the treatment-by-glycemic status interaction, the time-by-glycemic status interaction, and the treatment-by-time-by-glycemic status interaction, and Baseline body weight as a covariate."|Baseline, Week 12 (Day 85)|The pharmacodynamics (PD) analysis set included all subjects with available PD data and no protocol deviations with relevant impact on PD data. The analysis is based on all subjects with a Baseline body weight and at least one post-Baseline body weight measurement.|||percent change||80% Confidence Interval|Least Squares Mean
2575223|NCT02470390|Primary|Terminal Elimination Half-Life (t1/2) of Fentanyl in Plasma (5 of 5)|t1/2 (h)|24 hrs (pre-dose, 5, 10, 15, 20, 30, 45, & 60 min, and 1.5, 2, 3, 4, 6, 8, 12, & 24 hrs on Study Days 1 & 3 for Nasal Fentanyl / Sublingual Fentanyl; pre-dose, 2, 5, 10, 20, 30, & 60 min, and 2, 4, 6, 8, 12, & 24 hrs on Study Day 5 for IV Fentanyl)|The Plasma PK population included all subjects who received at least 1 dose of study drug and had at least 1 evaluable PK parameter.|||h||Geometric Coefficient of Variation|Geometric Mean
2575224|NCT02470390|Primary|Time to Reach Maximum Observed Concentration (Tmax) of Fentanyl in Plasma (4 of 5)|Tmax (h)|24 hrs (pre-dose, 5, 10, 15, 20, 30, 45, & 60 min, and 1.5, 2, 3, 4, 6, 8, 12, & 24 hrs on Study Days 1 & 3 for Nasal Fentanyl / Sublingual Fentanyl; pre-dose, 2, 5, 10, 20, 30, & 60 min, and 2, 4, 6, 8, 12, & 24 hrs on Study Day 5 for IV Fentanyl)|The Plasma PK population included all subjects who received at least 1 dose of study drug and had at least 1 evaluable PK parameter.|||h||Full Range|Median
2575225|NCT02470390|Primary|Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC 0-inf) of Fentanyl in Plasma (3 of 5)|AUC 0-inf (pg*h/mL)|24 hrs (pre-dose, 5, 10, 15, 20, 30, 45, & 60 min, and 1.5, 2, 3, 4, 6, 8, 12, & 24 hrs on Study Days 1 & 3 for Nasal Fentanyl / Sublingual Fentanyl; pre-dose, 2, 5, 10, 20, 30, & 60 min, and 2, 4, 6, 8, 12, & 24 hrs on Study Day 5 for IV Fentanyl)|The Plasma PK population included all subjects who received at least 1 dose of study drug and had at least 1 evaluable PK parameter. The AUC 0-inf values were excluded where %AUC extrap was greater than 20%.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2575226|NCT02470390|Primary|Area Under the Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUC 0-tlast) of Fentanyl in Plasma (2 of 5)|AUC 0-tlast (pg*h/mL)|24 hrs (pre-dose, 5, 10, 15, 20, 30, 45, & 60 min, and 1.5, 2, 3, 4, 6, 8, 12, & 24 hrs on Study Days 1 & 3 for Nasal Fentanyl / Sublingual Fentanyl; pre-dose, 2, 5, 10, 20, 30, & 60 min, and 2, 4, 6, 8, 12, & 24 hrs on Study Day 5 for IV Fentanyl)|The Plasma PK population included all subjects who received at least 1 dose of study drug and had at least 1 evaluable PK parameter.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2575227|NCT02470390|Primary|Maximum Observed Concentration (Cmax) of Fentanyl in Plasma (1 of 5)|Cmax (pg/mL)|24 hrs (pre-dose, 5, 10, 15, 20, 30, 45, & 60 min, and 1.5, 2, 3, 4, 6, 8, 12, & 24 hrs on Study Days 1 & 3 for Nasal Fentanyl / Sublingual Fentanyl; pre-dose, 2, 5, 10, 20, 30, & 60 min, and 2, 4, 6, 8, 12, & 24 hrs on Study Day 5 for IV Fentanyl)|The Plasma PK population included all subjects who received at least 1 dose of study drug and had at least 1 evaluable PK parameter.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2575228|NCT02470390|Primary|Area Under the Concentration-Time Curve From Hour 0 to Hour 6 (AUC 0-6h) of Fentanyl in Cerebrospinal Fluid (CSF) (3 of 3)||6 hrs (pre-dose, 5, 10, 20, 30, 45, & 60 min, and 2, 3, 4, & 6 hrs post-dose on Study Days 1 & 3)|The CSF PK population included all subjects who completed all study periods and Cmax was less than 5% pre-dose. The above CSF PK outcome compares nasal and sublingual fentanyl interventions.|||pg*h/mL||Standard Deviation|Mean
2575229|NCT02470390|Primary|Maximum Observed Concentration (Cmax) of Fentanyl in Cerebrospinal Fluid (CSF) (2 of 3)||6 hrs (pre-dose, 5, 10, 20, 30, 45, & 60 min, and 2, 3, 4, & 6 hrs post-dose on Study Days 1 & 3)|The CSF PK population included all subjects who completed all study periods and Cmax was less than 5% pre-dose. The above CSF PK outcome compares nasal and sublingual fentanyl interventions.|||pg/mL||Standard Deviation|Mean
2575230|NCT02470390|Primary|Time to Reach Maximum Observed Concentration (Tmax) of Fentanyl in Cerebrospinal Fluid (CSF) (1 of 3)||6 hrs (pre-dose, 5, 10, 20, 30, 45, & 60 min, and 2, 3, 4, & 6 hrs post-dose on Study Days 1 & 3)|The CSF PK population included all subjects who completed all study periods and Cmax was less than 5% pre-dose. The above CSF PK outcome compares nasal and sublingual fentanyl interventions.|||h||Full Range|Median
2575231|NCT02470312|Primary|Periprocedural Adverse Event|Adverse event until patients are discharged from the site center|From the day of CRT and EP procedure until patient discharge, expected stay is an average of 3 days||||ADVERSE EVENTS|||Number
2575232|NCT02470312|Primary|Amount of Fluoroscopy Time|Amount of fluoroscopy time during CRT implant or EP procedure|Expected time frame is day 1 of the study||||MINUTES||Standard Deviation|Mean
2615591|NCT01999192|Secondary|Simple Disease Activity Index [SDAI] ≤11||week 12 & 24|||||||
2575234|NCT02469961|Secondary|Number of Participants That Have Either Bradycardia or Hypotension|Number of participants observed with Bradycardia or Hypotension who required intervention|Participants will be followed from the start of sedation until discharge: approximately 3-5 hr|Number of patients who had Bradycardia or hypotension|||participants|||Number
2575235|NCT02469961|Secondary|Post Anesthesia Care Unit (PACU) Length of Stay|length of stay in minutes in the Post Anesthesia Care Unit before discharge|Arrival in the PACU until discharge either to home or to a hospital in-patient bed approximately 1-3 hr after the operation||||Minutes||Standard Deviation|Mean
2575236|NCT02469961|Primary|Number of Participants That Need an Airway Intervention.|airway manipulation or repositioning: apnea, oral airway, adjust head|Participants will be followed from the start of sedation until discharge: approximately 3-5 hr||||participants|||Number
2575237|NCT02469896|Secondary|Peripheral Benzodiazepine Receptor 28 (PBR28) Positron Emission Tomography (PET)|Measure the effects of tocilizumab on reducing glial activation measured by PBR28 PET in a subset of trial participants.|8 weeks|Only 2 patients met inclusion criteria for the PET portion of the study and thus, the data could not be statistically analyzed.|||Standardized Uptake Variable Ratio(SUVR)|||Number
2575238|NCT02469896|Secondary|Change in CSF Soluble Interleukin-6 (sIL-6) Receptor Concentrations|Target engagement will be assessed by comparing the mean change in CSF sIL-6 receptor concentrations (ng/mL) between baseline and week 8 of the placebo and active drug groups.|8 weeks|Discrepancies in the number of subjects analyzed are a result of subjects with missed data collection during the specific time points.|||ng/mL||95% Confidence Interval|Least Squares Mean
2575239|NCT02469896|Secondary|Change in Mean Concentration Cytokines in the Cerebrospinal Fluid (CSF)|Target engagement will be assessed by the mean change in CSF cytokine concentration between baseline and week 8 in ALS subjects receiving placebo or active drug.|8 weeks||||Fold change in concentration||95% Confidence Interval|Least Squares Mean
2575240|NCT02469896|Secondary|Changes in Cytokine Levels in the Plasma|Target engagement will be assessed by mean change in plasma cytokine concentration between weeks 4 and 16 in ALS subjects receiving placebo or active drug.|16 weeks|Discrepancies in the number of subjects analyzed are a result of subjects with missed data collection during the specific time points.|||Fold change in concentration||95% Confidence Interval|Least Squares Mean
2575241|NCT02469896|Secondary|Change in Peripheral Blood Mononuclear Cell (PBMC) Gene Expression|Target engagement will be assessed by comparing the PBMC fold change in cytokine gene expression from baseline to week 4-16 average of ALS patients receiving drug versus placebo.|16 weeks|Discrepancies in the number of subjects analyzed are a result of subjects with missed data collection during the specific time points.|||Fold change in gene expression||95% Confidence Interval|Geometric Mean
2575242|NCT02469896|Secondary|Rate of Decline Handheld Dynamometry (HHD)|Efficacy will be assessed by the change in the rate of change of HHD upper and lower extremity mega-scores. HHD utilizes an electronic pressure sensor to measure strength of individual muscles in kilograms. To calculate megascores, the mean and standard deviation of each muscle or muscle group, without regard to laterality, will be calculated from the baseline assessment of all participants. Strength estimates of each bilateral muscle or muscle group will be converted to Z scores by subtracting the relevant mean and dividing by the relevant standard deviation. Z scores for all upper extremity measurements (shoulder flexion, elbow flexion, elbow extension, wrist extension, and first dorsal interosseous contraction) and all lower extremity measurements (hip flexion, knee flexion, knee extension, and ankle dorsiflexion) will be averaged to yield upper and lower extremity megascores. Larger values indicate greater strength.|16 weeks|Discrepancies in the number of subjects analyzed are a result of subjects with missed data collection during the specific time points.|||Z-score||Standard Error|Mean
2575243|NCT02469896|Secondary|Rate of Decline ALS Functional Rating Scale Revised (ALSFRS-R)|Efficacy will be assessed by the mean change in ALSFRS-R total score.The ALSFRS-R scale measures the functional capabilities of an ALS patient in multiple domains such as swallowing, speech, fine motor, and breathing functions. It ranges from a maximum score of 48 for normal functioning to 0 for death or dependance on mechanical ventilation and declines by approximately 1 point per month on average for an ALS patient.|16 weeks|Discrepancies in the number of subjects analyzed are a result of subjects with missed data collection during the specific time points.|||units on a scale||Standard Error|Least Squares Mean
2575244|NCT02469896|Secondary|Rate of Decline in Slow Vital Capacity (SVC)|Efficacy will be assessed by the change in the rate of change of SVC as measured by change in percent predicted per month. The SVC is a measure of lung capacity that is reported as the percent of the predicted value expected based on gender and height. In ALS patients, this measure declines over time as a result of progressive respiratory muscle weakness.|16 weeks|Discrepancies in the number of subjects analyzed are a result of subjects with missed data collection during the specific time points.|||Percentage points change per month||Standard Error|Least Squares Mean
2575245|NCT02469896|Primary|Rates of All-cause Mortality|Safety will be assessed by the occurrence of all-cause mortality.|16 weeks||||Participants|||Count of Participants
2575246|NCT02469896|Primary|Number of Patients Tolerant to Study Drug|Tolerability will be assessed by on the proportion of participants remaining on study drug through all 3 doses and remaining on study and free from possibly drug-related and dose-limiting SAEs to the end of follow-up. Safety will be assessed by the occurrence of severe adverse events (SAEs), overall rates of adverse events (AEs), clinically significant abnormal laboratory tests, and changes in vital signs.|16 weeks||||Participants|||Count of Participants
2575247|NCT02469870|Secondary|Consumer Satisfaction Questionnaire|A 16-item scale was developed to evaluate parents' views of the feasibility, usability, and personal relevance of the program. It asked about the information taught in the program, the trainers, the website, and the other materials. The average score on these 19 items was evaluated and ranged from 1 to 6 with higher scores indicating more positive outcomes.|Follow up (6 weeks)||||average score on a scale||Standard Deviation|Mean
2575261|NCT02469701|Primary|Response Rate of the Combination of Ablation and the PD-1 Inhibitor Nivolumab for Patients With Non-small Cell Lung Cancer (NSCLC) Who Have Progressed Following at Least 1 Prior Chemotherapy Regimen for Metastatic or Locally Advanced Disease.|Assessment of tumor response by scan 12 weeks post the first dose of Nivolumab and approximately every 12 weeks after. Post progression by RECIST a 1 month confirmatory scan will be done and that will be the indicator of Progression.|Up to 5 years.|Number of patients that were not known to Progress|||Participants|||Count of Participants
2575248|NCT02469870|Secondary|Knowledge About Applied Behavior Analysis and Acceptance Commitment Training Measured by Questionnaire|Examining change over time points (T2-T1) 20 multiple choice knowledge items were developed during the project and were used to determine the extent to which participants understood basic program content, e.g., techniques parents can use to help their child master self‐care routines. These included questions about the principles of behavior support (gathering information, evaluating possible reinforcers, etc.), definitions of behavioral concepts (tantrums, reinforcement, antecedent), and application of these concepts. The total score ranged from 0 to 20 with higher scores indicating better outcomes.|Pre (0 weeks), Post (3 weeks)||||total correct answers||Standard Deviation|Mean
2575249|NCT02469870|Primary|Scales of Independent Behavior-Revised (SIB-R; Bruininks, Woodcock, Weatherman, & Hill, 1996)|"Examining change over time points (T2-T1)~The SBI-R is a 40-item, 7-point scale that measures 14 areas of adaptive behaviors and 8 areas of maladaptive behaviors.~We used the total adaptive scale with a total range of 0 to 120 with higher scores indicating better outcomes."|Pre (0 weeks), Post (3 weeks)||||total score on a scale||Standard Deviation|Mean
2575250|NCT02469870|Primary|Parenting Scale (Arnold, O'Leary, Wolff, & Aker, 1993)|Examining change over time points (T2-T1) Parenting Practices will be assessed using the Parenting Scale (PS; Arnold, O'Leary, Wolff, & Aker, 1993) a 30‐item, 7 point Likert-like scale with three subscales (laxness, over‐reactivity, and hostility). The scale has internal consistency for the total scale and subscales (α = .78 and ‐ .83 respectively) and has been evaluated for factor structure and validity (Rhoades & O'Leary, 2007). The average score on the total scale was used in the analysis with a range of 1 to 7 with lower scores indicating more positive outcomes.|Pre (0 weeks), Post (3 weeks),||||average score on a scale||Standard Deviation|Mean
2575251|NCT02469870|Primary|Family Quality of Life as Measured by Family Quality of Life Survey (Summers et al., 2005)|Examining change over time points (T2-T1) Quality of Life was measured using the Family Quality of Life survey (FQOL; Summers et al., 2005), which is a 25‐item measure of the quality of life for a family raising a child with intellectual or developmental disabilities. The outcomes measured are: quality of life in the domains of parenting, emotional well‐being, physical/material well‐being, and disability‐related supports using a 5‐point scale with responses ranging from (1) very dissatisfied to (5) very satisfied. The average score on the total scale was used in the analysis. The range is from 1 to 5 with higher scores indicating more positive outcomes.|Pre (0 weeks), Post (3 weeks)||||average score on a scale||Standard Deviation|Mean
2575252|NCT02469870|Primary|Child Behavior Measured by Strengths and Difficulties Questionnaire (Goodman, 1997)|Examining change over time points (T2-T1) This 25‐item parent‐report version of a behavioral screening questionnaire has been used with children aged 3 to 16 years of age. It assesses both positive and negative behaviors in the following domains: conduct problems, inattention‐hyperactivity, emotional symptoms, peer problems, and pro‐social behavior. The SDQ‐P has demonstrated acceptable psychometric properties and is available in Spanish (Goodman, 2001).Total range of scores is from 0 to 50. The prosocial items are reverse scored for the total scale so that on the total scale higher scores indicate worse behaviors.|Pre (0 weeks), Post (3 weeks)||||total score on a scale||Standard Deviation|Mean
2575253|NCT02469714|Secondary|Texas Christian University Health Form- Physical Health Subscale|Assesses physical health in the last 4 months and Emotional/Mental Health in the last 30 days.The scale ranges from 1 (None of the time) to 5 (All of the time). The higher the score, the more health problems. Score totals on the physical health scale range 14-70.|Baseline (0), 4, 8, and 12 months||||units on a scale||Standard Deviation|Mean
2575254|NCT02469714|Secondary|Availability Health Service Scale (AHSS)|The scale measures the availability of health services. The scale ranges from 1 (Not at all) to 9 (Very much). The lower the score the less availability of a service. Items were summed to get the total of each scale. Score totals range from 26-234.|Baseline (0), 4, 8, and 12 months||||units on a scale||Standard Deviation|Mean
2575255|NCT02469714|Secondary|Quality of Life Scale (QLS)|The QLS is highly used in services research and comprises 6 items of various domains of independent living. The scale ranges from 1 (terrible) to 7 (delighted). The lower the score the less quality of life. The total scores range 6-42.|Baseline (0), 4, 8, and 12 months||||units on a scale||Standard Deviation|Mean
2575256|NCT02469714|Secondary|Medical Outcome Study (SF-36)|This a 36 item short form that is widely adopted measure of medical health outcomes in mental health services research. Each item is scored on a 0 to 100 range. Items in same scale are averaged together to create the 8 scale scores. Higher scores indicate better health. In the current study, the total score it the sum of all scales scores. The total score can range from 0 to 800.|Baseline (0), 4, 8, and 12 months||||units on a scale||Standard Deviation|Mean
2575257|NCT02469714|Secondary|Recovery Assessment Scale (RAS)|The RAS assesses five factors related to recovery from mental illness including hope and goals. The scale ranges from 1 (strongly disagree) to 5 (strongly agree). A higher score reflects greater attitudes towards recovery. The total score range is 22-110.|Baseline (0), 4, 8, and 12 months||||units on a scale||Standard Deviation|Mean
2575258|NCT02469714|Secondary|Empowerment Scale (EMP)|This widely used scale examines multiple dimensions of perceived personal empowerment in people with serious mental illness.The scale ranges from 1 (strongly agree) to 4 (strongly disagree). The lower the score, the higher level of empowerment. The scores of each subscale range from 4 to 16.|Baseline (0), 4, 8, and 12 months||||units on a scale||Standard Deviation|Mean
2575259|NCT02469714|Secondary|Attitudes Toward Seeking Professional Psychological Help Scale (ATSPPH)|ATSPPH is a 29 item scale that has been used in more than 150 studies. The scale ranges from 1 (disagreement) to 4 (agreement). Higher overall scores reflect more positive attitudes towards help seeking. Subscales were summed to get the total of each scale. Total scores range from 29-116.|Baseline (0), 4, 8, and 12 months||||units on a scale||Standard Deviation|Mean
2575260|NCT02469714|Primary|Weekly Health Appointment Measure|This scale represents the total achieved appointments and total scheduled appointments. Data was collected weekly and added up per month.The minimum is 0 ( no appointments ) with no maximum (participants were not limited to the number of appointments per week).|Every week for up to 52 weeks||||appointments||Standard Deviation|Mean
2575262|NCT02469623|Primary|The Number of Patients for Which Activation Maps Can be Created|The primary performance endpoint was the number of subjects with successful construction of pre- and post-ablation procedure activation maps.|1 day|The study population consists of men and women between the ages of 18 – 75 years of age scheduled for an endocardial ablation for a supraventricular tachycardia (SVT)|||participants|||Number
2575263|NCT02469623|Primary|Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events|Sites reported all adverse events throughout the study follow-up period regardless of their relationship to the device or procedure. Each event was classified and adjudicated by the site-specific investigator. The data were further analyzed by the Sponsor medical reviewer, providing a consistent determination of relationship to device, procedure and the subjects' underlying disease of the atrial arrhythmia condition.|7 days||||Participants|||Count of Participants
2575264|NCT02469610|Secondary|Visual Analog Pain Scale|subjective patient's pain evaluation according to Visual Analog pain Scale (VAS). Visual Analog pain Scale a 1-10 score of pain. 1 being a lowest level of pain and 10 the worst pain felt by the patient.|post operative|"Visual Analog pain Scale on the first post-operative day. For each patient we calculate the average score of his answers to the question How do you rate your pain on the Visual Analog pain Scale ? during the first post-operative day."|||units on a scale||Standard Deviation|Mean
2575265|NCT02469610|Primary|Analgesic Use|The amount of analgesic medication consumption by patients during and after thoracoscopic surgery. the measurement include A. Analgesic usage during the hours of operation and recovery unit (4-8Hr) B. Analgesic usage during postoperative days (first, second, third and fourth for each 24 Hr)|post operative|the use of opioids in the operative day (post operative day 0)|||MG||Standard Deviation|Mean
2575266|NCT02469597|Secondary|Length of Hospital Stay||Participants will be followed for the duration of hospital stay up to 1 week||||Days||Standard Error|Least Squares Mean
2575267|NCT02469597|Secondary|Patient Needing Endotracheal Intubation||Within 72 hours of medication administration||||participants|||Number
2575268|NCT02469597|Primary|Oxygen Saturation||4 hours after medication adminstration||||Percentage change in oxygen saturation||Standard Error|Least Squares Mean
2575269|NCT02469597|Primary|Oxygen Saturation||2 hours after medication adminstration||||Percentage change in oxygen saturation||Standard Error|Least Squares Mean
2575270|NCT02469597|Primary|Respiratory Rate||4 hours after medication adminstration||||Percentage change in respiratory rate||Standard Error|Least Squares Mean
2575271|NCT02469597|Primary|Respiratory Rate||2 hours after medication adminstration||||Percentage change in respiratory rate||Standard Error|Least Squares Mean
2575272|NCT02469415|Primary|Overall Response Rate (ORR)|The primary efficacy outcome of both parts is the overall response rate (ORR) based mainly on hematologic improvement defined by (International Working Group) IWG-2006 criteria, and which also includes complete remission (CR), partial remission (PR) and marrow complete remission.|28 days|Two participants were taken off study when the investigational agent was placed on full clinical hold by the Food and Drug Administration (FDA). The two participants who received the study medication were not on study long enough to make a formal response assessment.||||||
2575273|NCT02469298|Secondary|Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14|Number of participants with no detectable influenza viral RNA by quantitative virus culture from nasopharyngeal swabs on Baseline (Day1), Day 3, Day 5, Day 8 and Day 14 were recorded. Assessments recorded on Day 1 were considered as Baseline.|Up to Day 14|IPP Population. Only those participants (number with nasopharyngeal samples) available at the specified time points were analyzed.|||Participants|||Count of Participants
2575274|NCT02469298|Secondary|Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14|Influenza viral load as measured by quantitative virus culture from nasopharyngeal swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 was recorded. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14|IPP population. Only those participants available at the specified time points were analyzed.|||Log median tissue culture infective dose||Standard Deviation|Mean
2575275|NCT02469298|Secondary|Total Dose of Relief Medication|Use of study supplied relief medications (paracetamol and dextromethorphan for symptom relief were recorded in the eDiary and accordingly number of participants using these medications were recorded. The total dose of these relief medications used by these participants are presented.|Up to Day 28/withdrawal|Safety population. Only those participants using relief medication were analyzed.|||Milligrams||Full Range|Median
2575276|NCT02469298|Secondary|Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14|Number of participants with no detectable influenza viral ribonucleic acid (RNA) by qRT-PCR from nasopharyngeal swabs on Baseline (Day1), Day 3, Day 5, Day 8 and Day 14 were recorded. Assessments recorded on Day 1 were considered as Baseline.|Up to Day 14|IPP Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2575277|NCT02469298|Secondary|Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14|Influenza viral load as measured by quantitative reverse transcription - polymerase chain reaction (qRT-PCR) from nasopharyngeal swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 was recorded. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14|IPP population. Only those participants available at the specified time points were analyzed.|||Log viral particles/mL||Standard Deviation|Mean
2575278|NCT02469298|Secondary|Number of Hospital Admissions Due to Influenza Infection|Number of participants admitted in hospital due to influenza infection was recorded.|Up to Day 28/withdrawal|Safety population|||Participants|||Number
2575279|NCT02469298|Secondary|Number of Participants Who Used Relief Medication|Use of study supplied relief medications (paracetamol and dextromethorphan for symptom relief were recorded in the eDiary and accordingly number of participants using these medications were recorded.|Up to Day 28/withdrawal|Safety population.|||Participants|||Count of Participants
2575291|NCT02469298|Primary|Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick)|The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine glucose can be read as negative, Trace, 1+ or 1/4 gram per deciliter (G/dL), 2+ OR 1/2 G/dL, 3+ or 1 G/dL and 4+ indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.|Up to Day 28/withdrawal|Safety population|||Participants|||Count of Participants
2575280|NCT02469298|Secondary|Number of Afebrile Participants Over Time Post Initiation of Treatment|Afebrile participants were defined as participants with oral temperature <=37.2 degree Celsius, <=99.0 degree Fahrenheit over time post initiation of treatment. Temperature was taken orally and recorded in the eDiary, thrice daily from Day 1 to Day 5 (morning, noon, evening) and twice daily (morning, evening) from Day 6 to Day 14 by the participant using a digital thermometer provided by the study. For participants whose fever was not resolved by the Day 14 visit then after Day 14, participants continued to take oral temperature twice daily until temperature <=37.2 degree Celsius or <=99 degree Fahrenheit for 24 hours.|Up to Day 28/withdrawal|IPP population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2575281|NCT02469298|Secondary|Time to Resolution of Fever Over Time Post Initiation of Treatment|Time to resolution of fever was defined as the time when oral temperature was <= 37.2 degree Celsius (<=99.0 degree Fahrenheit) for at least 24 hours (with one hour window) without having taken any antipyretic medication for at least 4 hours. Temperature was taken orally and recorded in the eDiary, thrice daily from Day 1 to Day 5 (morning, noon, evening) and twice daily (morning, evening) from Day 6 to Day 14 by the participant using a digital thermometer provided by the study. For participants whose fever was not resolved by the Day 14 visit then after Day 14, participants continued to take oral temperature twice daily until temperature <=37.2 degree Celsius or <=99 degree Fahrenheit for 24 hours.|Up to Day 28/withdrawal|Influenza positive population (IPP) comprised of all randomized participants who received at least one dose of IP with proven influenza infection (positive rapid antigen test and positive influenza by quantitative reverse transcription-polymerase chain reaction (qRT-PCR) or culture test at any time point). Participants with fever are analyzed.|||Hours||Full Range|Median
2575282|NCT02469298|Primary|Number of Participants With DRE of Interest-associated Antibiotic Use|Use of antibiotics for DREs of interest was monitored. Roxithromycin was used for DRE sinusitis by one participant.|Up to Day 28/withdrawal|Safety population|||Participants|||Count of Participants
2575283|NCT02469298|Primary|Number of Participants With Disease Related Events (DREs) of Interest|Disease-related events of interest included Otitis media, Sinusitis, Bronchitis and Pneumonia and were captured separately from AEs and SAEs. DREs of interest were assessed and recorded by the site on all clinical visit days.|Up to Day 28/withdrawal|Safety population|||Participants|||Count of Participants
2575284|NCT02469298|Primary|Change From Baseline in Electrocardiogram (ECG) Parameters|12-lead ECGs were obtained on Day 1, Day 3 and Day28/withdrawal using an ECG machine that automatically calculates and measures RR, PR, QRS, QT, and Corrected QT Interval using Bazette's formula (QTcB) and Corrected QT Interval using Fridericia forumula (QTcF) intervals. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Millisecond (msec)||Standard Deviation|Mean
2575285|NCT02469298|Primary|Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB)|Vital signs were measured in semi-supine position after 5 minutes rest and included POB. POB was obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Percentage (%)||Standard Deviation|Mean
2575286|NCT02469298|Primary|Change From Baseline in Vital Signs- Temperature|Vital signs were measured in semi-supine position after 5 minutes rest and included temperature. Oral temperature was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Centigrade||Standard Deviation|Mean
2575287|NCT02469298|Primary|Change From Baseline in Vital Signs- Respiration Rate (RR)|Vital signs were measured in semi-supine position after 5 minutes rest and included RR. RR was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Breaths per minute||Standard Deviation|Mean
2575288|NCT02469298|Primary|Change From Baseline in Vital Signs- Heart Rate (HR)|Vital signs were measured in semi-supine position after 5 minutes rest and included HR. Three readings of pulse rate were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2575289|NCT02469298|Primary|Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|Vital signs were measured in semi-supine position after 5 minutes rest and included systolic and diastolic blood pressure. Three readings of blood pressure were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2575290|NCT02469298|Primary|Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick)|The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.|Up to Day 28/withdrawal|Safety population|||Participants|||Count of Participants
2575370|NCT02468583|Secondary|Percent of Responders (Defined as Patients With High Improvement in Pain or Function) According to OMERACT-OARSI Criteria at Weeks 4, 8 and 12||12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
2575292|NCT02469298|Primary|Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick)|The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine occult blood can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.|Up to Day 28/withdrawal|Safety population.|||Participants|||Count of Participants
2575293|NCT02469298|Primary|Change From Baseline in Urinalysis Parameters- Urine Specific Gravity|Urinalysis parameter included Urine specific gravity and was measured on Day 1, Day 5 and Day 28. Urinary specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1), Day 5 and Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2575294|NCT02469298|Primary|Change From Baseline in Urinalysis Parameters- Urine pH|Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. Urinalysis was done on Day 1, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1), Day 5 and Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Points on a scale||Standard Deviation|Mean
2575295|NCT02469298|Primary|Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)|Clinical chemistry parameters included Calcium, CO2 content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/(BUN). Blood samples were collected on Day 1, Day 3, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Millimoles per Liter (MMOL/L)||Standard Deviation|Mean
2575296|NCT02469298|Primary|Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid|Clinical chemistry parameters included Direct Bilirubin, Total Bilirubin, Creatinine and Uric acid. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Micromole per Liter (UMOL/L)||Standard Deviation|Mean
2575297|NCT02469298|Primary|Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT)|Clinical chemistry parameters included Alkaline phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase and Gamma Glutamyl Transferase. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||International Units per litre (IU/L)||Standard Deviation|Mean
2575298|NCT02469298|Primary|Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein|Clinical chemistry parameters included Albumin and Total protein. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Grams per Litre (G/L)||Standard Deviation|Mean
2575299|NCT02469298|Primary|Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count|Hematology parameters included RBC count and Reticulocytes count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Trillion cells per Liter (TI/L)||Standard Deviation|Mean
2575300|NCT02469298|Primary|Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV)|Hematology parameters included Mean corpuscle volume (MCV). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Femtoliters (FL)||Standard Deviation|Mean
2575301|NCT02469298|Primary|Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH)|Hematology parameters included Mean corpuscle hemoglobin (MCH). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Picogram (PG)||Standard Deviation|Mean
2575302|NCT02469298|Primary|Change From Baseline in Hematology Parameters- Hematocrit|Hematology parameters included Hematocrit. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Fraction||Standard Deviation|Mean
2575303|NCT02469298|Primary|Change From Baseline in Hematology Parameters- Hemoglobin|Hematology parameters included Hemoglobin. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Grams per Litre (G/L)||Standard Deviation|Mean
2575371|NCT02468583|Secondary|Clinical Global Impression of Change (CGIC) at Weeks 4, 8 and 12||12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
2575304|NCT02469298|Primary|Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count|Hematology parameters included Basophils, Eosinophils, Lymphocytes, Monocytes, Total neutrophils (Total ANC), Platelet count and WBC count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.|Baseline (Day 1) and up to Day 28/withdrawal|Safety population. Only those participants available at the specified time points were analyzed.|||Giga cells per litre (GI/L)||Standard Deviation|Mean
2575305|NCT02469298|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to Day 28/withdrawal|Safety population comprised of all randomized participants who received at least one dose of investigational product (IP).|||Participants|||Count of Participants
2575306|NCT02469246|Secondary|Percent Change From Baseline in Spine BMD at Week 96||Baseline; Week 96|Participants in the Spine DXA Analysis Set with available data were analyzed.|||percent change||Standard Deviation|Mean
2575307|NCT02469246|Secondary|Percent Change From Baseline in Spine BMD at Week 48||Baseline; Week 48|Participants in the Spine DXA Analysis Set (all participants who are randomized and have received at least one dose of study drug, and have nonmissing baseline spine BMD values) with available data were analyzed.|||percent change||Standard Deviation|Mean
2575308|NCT02469246|Secondary|Percent Change From Baseline in Hip BMD at Week 96||Baseline; Week 96|Participants in the Hip DXA Analysis Set with available data were analyzed.|||percent change||Standard Deviation|Mean
2575309|NCT02469246|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48||Baseline; Week 48|Participants in the Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set (all participants who are randomized and have received at least one dose of study drug, and have nonmissing baseline hip BMD values) with available data were analyzed.|||percent change||Standard Deviation|Mean
2575310|NCT02469246|Secondary|Change From Baseline in CD4 Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with available data were analyzed.|||cells/μL||Standard Deviation|Mean
2575311|NCT02469246|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||cells/µL||Standard Deviation|Mean
2575312|NCT02469246|Secondary|Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2575313|NCT02469246|Secondary|Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2575314|NCT02469246|Secondary|Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2575315|NCT02469246|Secondary|Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2575316|NCT02469246|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Determined by the FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2575317|NCT02469246|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Determined by the FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|The Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. Participants were grouped according to the treatment to which they were randomized.|||percentage of participants|||Number
2575372|NCT02468583|Secondary|Patient Global Impression of Change (PGIC) at Weeks 4, 8 and 12||12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
2575489|NCT02466230|Other Pre-specified|Glutamate Level Measured by Magnetic Resonance Spectroscopy|Percent change in medial prefrontal glutamate level|Baseline to immediately after the final rTMS treatment (5 weeks)|||||||
2575318|NCT02469168|Secondary|Number of Participants With Confirmed Treatment Area Closure|Complete wound closure is defined as skin wound re-epithelialization at 95% or greater at treated wound site and donor sites confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for ReCell-treated areas as compared to control areas.|Prior to or at 6 weeks|did not enroll any additional participants|||Participants|||Count of Participants
2575319|NCT02469168|Primary|Number of Participants With Adverse Event|Number of patients with a treatment-related adverse events requiring surgical intervention prior to Week 12 post-treatment and all serious adverse event (SAE) occurrences throughout the study|Prior to or at 12 weeks|did not enroll any additional participants|||Participants|||Count of Participants
2575320|NCT02469116|Other Pre-specified|Adverse Events as Measured by Number of Events Experienced by All Participants||30 days after completion of treatment (approximately 22 weeks)||||events|||Number
2575321|NCT02469116|Secondary|Quality of Life (QoL) as Measured by FACT-O Assessment Tool|"The FACT-O questionnaire consists of a Physical Well-Being Section, Social/Family Well-Being Section, Emotional Well-Being Section, Functional Well-Being Section, and Additional Concerns Section~Answers range from Not at all to Very Much with 0 = not at all and 4 = very much"|Completion of follow-up|The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.||||||
2575322|NCT02469116|Secondary|Progression-free Survival (PFS)|-Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.|Completion of follow-up|The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.||||||
2575323|NCT02469116|Secondary|Overall Survival (OS)|Overall Survival is the observed length of life from entry into the study to death or the date of last contact|Completion of follow-up|The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.||||||
2575324|NCT02469116|Secondary|Time to Progression (TTP)|Progressive disease is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Unequivocal progression of existing non-target lesions, other than pleural effusions without cytological proof of neoplastic origin, in the opinion of the treating physician within 8 weeks of study entry is also considered increasing disease (in this circumstance an explanation must be provided). In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% increase in the LD is required.|Completion of follow-up|The sponsor withdrew funding for the study which meant there was no funding for completion of accrual, follow-up or statistical analysis.||||||
2575325|NCT02469116|Secondary|Efficacy of Regimen as Measured by CA-125 Response|"Progression is defined as one of the following:~Patients with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 ≥ twice the upper limit of normal on two occasions at least one week apart~Patients with elevated CA-125 pretreatment which never normalizes must show evidence of CA-125 ≥ 2 times the nadir value OR > 50% increase from the nadir on two occasions at least one week apart,~Patients with CA-125 in the normal range pretreatment must show evidence of CA-125 ≥ two times the upper limit of normal on two occasions at least one week apart.~Complete response is defined as a CA-125 value <13 confirmed on two occasions at least 2 weeks apart.~Partial Response is defined as a reduction of at least 50% from the original elevated CA-125 value (original value must have been > 50), confirmed on two occasions at least 2 weeks apart.~Stable Disease is defined as not meeting one of the above criteria."|Completion of treatment (approximately 18 weeks)||||participants|||Number
2575326|NCT02469116|Primary|Incidence of Grade 3-4 Neutropenia as Measured by CTCAE Version 3||Through 30 days after completion of treatment (approximately 22 weeks)||||participants|||Number
2575327|NCT02469064|Secondary|Changes in Maximum Inspiratory Pressure (MIP)|Changes in Maximum Inspiratory Pressure (MIP) was considered as Final MIP minus baseline MIP|Measured at baseline (baseline MIP) and right before patient extubation (finalMIP, an average of 2 hours)|24 patients did not reach a measurement of the Final MIP, of them, 14 belonged to the experimental treatment group and 10 to the conventional treatment group; therefore this result was analyzed in 102 patients.|||cmH20||Standard Deviation|Mean
2575328|NCT02469064|Primary|Weaning Time From Mechanical Ventilation|Weaning time was considered as time elapsed from beginning of pressure support mode in mechanical ventilation (Pressure support at 10 centimeters of water (cmsH2O) or less) or continuous positive pressure in the airway mode (CPAP) until patient extubation|Measured by the end of the period of mechanical ventilation, an average expected time of 4 days||||hours||Inter-Quartile Range|Median
2575329|NCT02468934|Secondary|Subject Satisfaction Survey|Subjects completed a sponsor-developed survey with questions pertaining to their feelings about the SPRINT Stimulation System as a method for managing post-surgical pain.|Visit 11 (6-weeks post-Total Knee Arthroplasty (TKA))|Two subjects did not answer the question regarding the amount of time it took to feel pain relief from stimulation.|||Participants|||Count of Participants
2575330|NCT02468934|Secondary|Time to Meet Recovery Milestones up to Three Months Post-Total Knee Arthroplasty (TKA)|Participants were queried weekly from the date of their Total Knee Arthroplasty (TKA) until they met specific, post-surgical recovery milestones. Participants were queried up through the time at which they meet each milestone or through their completion of the study, whichever came first (up to three months post-surgery).|From Day of Surgery through completion of milestone or 3-months from Day of Surgery, whichever came first|Data were not available for climbing stairs and discharge destination for 3 subjects and for discharge criteria and clearance to drive for one. Data were not collected for clearance to work in 2 subjects, and 10 subjects were retired. Opioid cessation data were not collected for 1 subject, and 2 subjects did not cease opioids during the study.|||days||Inter-Quartile Range|Median
2575373|NCT02468583|Secondary|Knee Injury and Osteoarthritis Score (KOOS)|change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12|12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
2575374|NCT02468583|Secondary|WOMAC (Total):|change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12|12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
2575331|NCT02468934|Secondary|Pain Catastrophizing Scale (PCS)|"The Pain Catastrophizing Scale (PCS) questionnaire has 13 questions that assess rumination, magnification, and helplessness. Subjects are asked to think back on painful experiences in the past and reflect on how often they had specific thoughts or feelings. Each of the 13 questions is scored on a 5-point scale where 0 represents not at all, and 4 represents all the time. The scores from each question were summed for each subject to provide a total PCS score, with a possible range from 0 to 52 with higher scores indicating a greater tendency to catastrophize pain (i.e. a higher score indicates a worse outcome). The median scores were then calculated across all subjects."|Visit 1 (Baseline), Visit 11 (6-weeks post-Total Knee Arthroplasty (TKA)), Visit 13 (3-months post-TKA)||||Scores on a scale||Inter-Quartile Range|Median
2575332|NCT02468934|Secondary|Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey|"The Patient Global Impression of Change (PGIC) asks subjects to rate their improvement with treatment on a 7-point scale ranging from very much worse to very much improved as compared to before their knee replacement surgery. The subjects combine all the components of their experience into one overall score. Ratings of Much- or Very Much Improved are considered Meaningful Improvements; similarly, ratings of Much- or Very Much Worse are categorized as Meaningfully Worse."|Visits 5-13 (in-hospital through 3-months post-Total Knee Arthroplasty (TKA))|Data was not collected for two subjects at Visit 5, for three subjects at Visit 10, and for one subject at Visit 12.|||Participants|||Count of Participants
2575333|NCT02468934|Secondary|Knee Pain Interference With Daily Activities|Subjects were asked to rate the degree to which their knee pain has interfered with 7 different aspects of their daily life on a scale from 0 to 10, with higher scores indicating greater interference. Those 7 scores were averaged for each subject to provide an overall pain interference score, with a possible range of 0 to 10 with higher scores indicating greater interference. The median score was then calculated across subjects.|Visit 1 (Baseline), Visit 2 (Lead Placement), Visits 5-13 (in-hospital days through 3-months post-Total Knee Arthroplasty (TKA))|Data was not collected for: 10 subjects at Visit 2, two subjects at Visit 10, and one subject at Visit 12.|||Scores on a scale||Inter-Quartile Range|Median
2575334|NCT02468934|Secondary|Percent Change From Baseline on the Western Ontario McMaster University Osteoarthritis Index (WOMAC)|"The Western Ontario McMaster University Osteoarthritis Index (WOMAC) questionnaire consists of 24 items that evaluate pain, stiffness, and physical functional disability. Each item is scored on an 11-point numerical rating scale from 0 to 10, where higher scores indicate greater pain, stiffness, and disability. For each subject, the scores from each of the 24 items were summed to calculate the subject's total score, with a minimum score of 0 and a maximum score of 240. Percent change from baseline was calculated for each subject at each time point (i.e., value at Visit 5 vs. Baseline rating, value at Visit 7 vs. Baseline rating, value at Visit 11 vs. Baseline rating, and value at Visit 13 vs. Baseline rating). The median percent change across subjects was determined. Negative values indicate worsening since Baseline, while positive values indicate improvement from Baseline.~Percent improvement = 100 x ([rating at each study visit]-[rating at baseline]) / [rating at baseline]."|Visit 1 (Baseline), Visit 5 (In-Hospital), Visit 7 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)|Data was not collected for two subjects at Visit 5.|||percent change||Inter-Quartile Range|Median
2575335|NCT02468934|Secondary|Fixed Distance Walk Test|The amount of time it took subjects to walk a fixed distance of 20 meters was recorded.|Visit 1 (Baseline) and Visit 5 (In-Hospital)|One subject at Visits 1 and 5 was physically unable to complete the test. Data was not collected for two additional subjects at Visit 5, and another subject walked a fixed distance greater than 20 meters during the test so their results are not comparable.|||seconds||Inter-Quartile Range|Median
2575336|NCT02468934|Secondary|6 Minute Walk Test (6MWT)|The total distance that a subject could walk in 6 minutes was recorded, and the mean distance was determined across subjects. 6 Minute Walk Test distances are expected to be reduced immediately after surgery as compared to baseline.|Visit 1 (Baseline), Visit 7 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)|One subject at Visit 1 and two subjects at Visit 7 were physically unable to complete the test. Data was not collected for an additional subject at Visit 7.|||meters||Standard Error|Mean
2575337|NCT02468934|Secondary|Timed Up and Go (TUG) Test|Subjects began this test from a seated position in a standard chair and were timed while they stood up, walked to a marked point 10 feet away (at a normal, safe pace), returned to the chair, and sat down. Timed Up and Go (TUG) test times are expected to be greater immediately after surgery as compared to baseline.|Visit 1 (Baseline), Visit 5 (In-Hospital), Visit 7 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)|Data was not collected for two subjects at Visit 5 and another subject was physically unable to complete the test. Data was not collected for one subject at Visit 7.|||Seconds||Inter-Quartile Range|Median
2575338|NCT02468934|Secondary|Time to Achieve 90 Degrees Flexion in Affected Knee|Active range of motion (AROM; no assistance from clinical staff) and passive range of motion (PROM; assisted by clinical staff) was assessed with both stimulation on and off. The time that it took subjects to achieve the milestone of 90 degrees of knee flexion in their affected leg is reported.|Visit 2 (Lead Placement), Visit 7 (3-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA)|Three subjects did not meet 90 degrees of flexion with stimulation on by Visit 11 (End of Treatment) for both active range of motion (AROM) and passive range of motion (PROM). Data was not collected for four subjects for PROM with stimulation on and for three subjects for AROM with stimulation on.|||days||Inter-Quartile Range|Median
2575339|NCT02468934|Secondary|Number of Participants That Experienced at Least One Opioid-Related Side Effect|Throughout the study, subjects were asked if they experienced any side effects related to opioid pain medications. The occurrences of these side effects were recorded and were not reported as Adverse Events. The number of subjects that experienced at least one opioid-related side effect at each visit is reported.|Visit 1 (Baseline), Visit 2 (Lead Placement), Visits 5-13 (in-hospital days through 3-months post-Total Knee Arthroplasty (TKA))|Data was not collected for: eight subjects at Visit 2, two subjects at Visit 10, and one subject at Visit 12.|||Participants|||Count of Participants
2575375|NCT02468583|Secondary|WOMAC C (Function)|change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12|12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
2575340|NCT02468934|Secondary|Amount of Analgesic Usage|The amount and type of analgesics used by subjects was recorded in daily diaries. Narcotic usage was converted into a morphine equivalent dosage (MED), which is measured in units of morphine milligram equivalents (MME). Diaries were collected at various visits throughout the study, and for consistency, these data were translated into post-operative days. The average MED was calculated for each subject for the first 42 days (6 weeks) following surgery, and the median of these averages was determined across subjects.|Visit 4 (Day of Surgery) and Visits 6-11 (weeks 1-6 post-Total Knee Arthroplasty (TKA))|Data was not available for: one subject during Post-op Week 1, three subjects for Weeks 2 and 4, four subjects during Weeks 3 and 5, and for seven subjects during Post-op Week 6.|||MME (Morphine Milligram Equivalents)||Inter-Quartile Range|Median
2575341|NCT02468934|Secondary|Average Knee Pain at Rest|"Subjects were asked to complete daily diaries to track their average pain intensity at rest in the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents No Pain and 10 represents Pain as bad as you can imagine. The average score for each diary period was calculated across subjects, and the mean score for weeks 1-4 is reported."|Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))||||Scores on a scale||Standard Error|Mean
2575342|NCT02468934|Secondary|Average Knee Pain Over the Last 24 Hours|"Subjects were asked to complete daily diaries to track their average pain intensity in the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents No Pain and 10 represents Pain as bad as you can imagine. The average score for each diary period was calculated across subjects, and the mean score for weeks 1-4 is reported."|Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))||||Scores on a scale||Standard Error|Mean
2575343|NCT02468934|Primary|Number of Participants That Experienced at Least One Study-Related Adverse Event|At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition has occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.|Total of 21 months (from when the first subjects enrolled to when the last subject completed the study)||||Participants|||Count of Participants
2575344|NCT02468934|Primary|Average Knee Pain While Walking|"Subjects were asked to complete daily diaries to track their average pain intensity while walking during the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents No Pain and 10 represents Pain as bad as you can imagine. The average score for each diary period was calculated across subjects, and the mean scores for weeks 1-4 is reported."|Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))||||Scores on a scale||Standard Error|Mean
2575345|NCT02468830|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Mirabegron|Cardiovascular safety: mean difference in heart rate (variation in heart rate increase of more than 20%). Heart rate was taken at initiation of study drug, at each visit and at the study end.|Participants will be followed for the duration of the study, up to 52 weeks||||Participants|||Count of Participants
2575346|NCT02468830|Secondary|Improved Quality of Life Using the Patient Perception of Bladder Condition (PPBC) Scale|"The Patient Perception of Bladder Condition (PPBC) scale on a 6-point score scale at baseline and final visit.~Explanation of possible answer:~does not cause me any problems at all,~causes me some very minor problems,~causes me some minor problems,~causes me (some) moderate problems,~causes me severe problems,~causes me many severe problems"|Participants will be followed for the duration of the study, up to 52 weeks||||units on a scale||Inter-Quartile Range|Median
2575347|NCT02468830|Secondary|Number of Participants With Cardio Vascular Safety|"Cardiovascular safety: mean difference in blood pressure (Variation in blood pressure: systolic ±20 mmHg, diastolic ±15 mmHg).~Parameters to be measure at each visit but particularly at visit 2 (Week 0, first dose on site), to be obtained before and 1 hour after taking the medication)."|Participants will be followed for the duration of the study, up to 52 weeks||||Participants|||Count of Participants
2575348|NCT02468830|Primary|Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron|Change in mean bladder capacity from baseline to final visit based on voiding diary.|Participants will be followed for duration of the study, up to 52 weeks||||milliliter||Inter-Quartile Range|Median
2575349|NCT02468830|Primary|Improved Overactive Bladder Symptoms as a Measure of Efficacy of Mirabegron|Percent change in the frequency of urinary incontinence episodes as a Measure of Efficacy.|Participants will be followed for the duration of the study, up to 52 weeks||||Participants|||Count of Participants
2575350|NCT02468700|Primary|Total Conjunctival Lissamine Green Staining|National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining)|Day 30||||units on a scale||Standard Deviation|Mean
2575351|NCT02468700|Primary|Total Conjunctival Lissamine Green Staining|National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining)|Day 15||||units on a scale||Standard Deviation|Mean
2575352|NCT02468700|Primary|Total Corneal Fluorescein Staining|National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining)|Day 30||||units on a scale||Standard Deviation|Mean
2575353|NCT02468700|Primary|Total Corneal Fluorescein Staining|National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining)|Day 15||||units on a scale||Standard Deviation|Mean
2575354|NCT02468674|Secondary|Population II: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49|LBM is defined as the Total soft tissue fat-free body mass. A high LBM represents better pharmacodynamic effect|Week 49|The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.|||kg||Geometric Coefficient of Variation|Geometric Mean
2575355|NCT02468674|Secondary|Population I: Total Lean Body Mass (LBM) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49|LBM is defined as the Total soft tissue fat-free body mass. A high LBM represents better pharmacodynamic effect|Week 49|The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.|||kg||Geometric Coefficient of Variation|Geometric Mean
2575356|NCT02468674|Secondary|Population II: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49|ASMI is a core requirement for determining the presence of sarcopenia and is calculated as the sum of the appendicular lean mass (kg) of the two upper and two lower limbs quantified by DXA, divided by height (m2). Therefore, an increase in ASMI indicates an increase in the quantity of an individual's lean mass.|Week 49|The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.|||kg/m^2||Geometric Coefficient of Variation|Geometric Mean
2575357|NCT02468674|Secondary|Population I: Appendicular Skeletal Muscle Index (ASMI) as Measured by Dual Energy X-ray Absorptiometry (DXA) at Week 49|ASMI is a core requirement for determining the presence of sarcopenia and is calculated as the sum of the appendicular lean mass (kg) of the two upper and two lower limbs quantified by DXA, divided by height (m2). Therefore, an increase in ASMI indicates an increase in the quantity of an individual's lean mass.|Week 49|The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.|||kg/m^2||Geometric Coefficient of Variation|Geometric Mean
2575358|NCT02468674|Secondary|Population II: Gait Speed at Week 49|Gait Speed was assessed as part of SPPB, over a 4 meter distance of a 6 meter course. Gait speed assesses a person's usual walking speed, which is defined as the speed a person normally walks from one place to another. Poor functional performance is measured by slow or declining gait speed.|Week 49|The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.|||m/sec||Standard Deviation|Mean
2575359|NCT02468674|Secondary|Population I: Gait Speed at Week 49|Gait Speed was assessed as part of SPPB, over a 4 meter distance of a 6 meter course. Gait speed assesses a person's usual walking speed, which is defined as the speed a person normally walks from one place to another. Poor functional performance is measured by slow or declining gait speed.|Week 49|The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.|||m/sec||Standard Deviation|Mean
2575360|NCT02468674|Secondary|Population II: 6-minute Walking Distance (6MWT) at Week 49|The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. A high 6MWT represent better physical condition.|Week 49|The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.|||meters||Standard Deviation|Mean
2575361|NCT02468674|Secondary|Population I: 6-minute Walking Distance (6MWT) at Week 49|The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. A high 6MWT represent better physical condition.|Week 49|The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.|||meters||Standard Deviation|Mean
2575362|NCT02468674|Primary|Population II: Short Physical Performance Battery (SPPB) Total Score at Week 49|SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function).|Week 49|The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.|||Scores on a scale||Standard Deviation|Mean
2575363|NCT02468674|Primary|Population I: Short Physical Performance Battery (SPPB) Total Score at Week 49|SPPB evaluates lower extremities in three functional components: maintenance of standing balance, usual gait speed and chair stand. Each test yields a score on a scale from 0 to 4 (total score 0-12, with the higher score reflecting a higher level of function).|Week 49|The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. For post Week 25 assessments, only the subjects with assessment available at both the Visit and Week 25 are included in the calculation of the respective Visit statistics.|||Scores on a scale||Standard Deviation|Mean
2575364|NCT02468648|Secondary|Number of Participants Who Maintained HCV RNA Levels in Liver and Serum Less Than Lower Limit of Quantification (LLOQ)||24 weeks||||Participants|||Count of Participants
2575365|NCT02468648|Secondary|Number of Participants Who Sustained Virologic Response|Absence of detectable virus 24 weeks after completion of antiviral therapy|24 weeks||||Participants|||Count of Participants
2575366|NCT02468648|Primary|Number of Participants Who Maintained HCV RNA Levels in Liver and Serum Less Than Lower Limit of Quantification (LLOQ)||4 weeks||||Participants|||Count of Participants
2575367|NCT02468648|Primary|Number of Participants With Sustained Virologic Response|Absence of detectable virus 12 weeks after completion of antiviral therapy|12 weeks||||Participants|||Count of Participants
2575368|NCT02468583|Secondary|Average Weekly and Total Consumption of Rescue Medication||12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
2575369|NCT02468583|Secondary|Time to Onset of Pain Relief|Time to onset of pain relief in days is defined as the time from first dose to the first daily pain assessment showing >30% improvement from the weekly mean of the average daily (24-hr) pain intensity scores at Baseline|Baseline to >30% improvement|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
2575376|NCT02468583|Secondary|WOMAC B (Stiffness)|change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12|12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
2575377|NCT02468583|Secondary|WOMAC A1 (Pain on Walking Question)|change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12|12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
2575378|NCT02468583|Secondary|WOMAC A (Pain Subscale)|change from Baseline to Weeks 4, 8 and 12 average change from Baseline over Weeks 4 to 8 and Weeks 4 to 12|12 weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
2575379|NCT02468583|Secondary|Proportion of Patients Experiencing Each of >50% or >30% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week||12 Weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
2575380|NCT02468583|Secondary|Proportion of Patients Experiencing a >50% or >30% Decrease in Pain From Baseline in Weekly Mean of Average Daily 24-hr Pain Intensity Scores at Each Week||12 Weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
2575381|NCT02468583|Secondary|Proportion of Patients Experiencing a >20% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Each Week||12 Weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
2575382|NCT02468583|Secondary|Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores, Change From Baseline to Each Week and Average Change From Baseline Over Weeks 1 to 12 and Weeks 4 to 12|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|12 Weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
2575383|NCT02468583|Primary|Average Change From Baseline in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores Over Weeks 5 to 10|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|5-10 Weeks|Given that the study was closed early, with only 5% of the planned study population enrolled, efficacy data were not analyzed.||||||
2575384|NCT02468414|Primary|Patients Who Achieved Biological Activity of MDGN201 TARGTEPO Secretion as Measured by Serum EPO Levels Above Baseline.||52 weeks|No statistical analysis was performed as only one subject was treated with MDGN201 TARGTEPO due to the Sponsor's decision to discontinue study.|||Participants|||Count of Participants
2575385|NCT02468193|Secondary|Plasma Concentrations of Osilodrostat (LCI699) at Week 24|Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.|Week 24, 2 hours post-dose|Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).|||ng/mL||Standard Deviation|Mean
2575386|NCT02468193|Secondary|Plasma Concentrations of Osilodrostat (LCI699) at Week 20|Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.|Week 20, 2 hours post-dose|Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).|||ng/mL||Standard Deviation|Mean
2575387|NCT02468193|Secondary|Plasma Concentrations of Osilodrostat (LCI699) at Week 16|Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.|Week 16, 2 hours post-dose|Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).|||ng/mL||Standard Deviation|Mean
2575388|NCT02468193|Secondary|Plasma Concentrations of Osilodrostat (LCI699) at Week 12|Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.|Week 12|Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).|||ng/mL||Standard Deviation|Mean
2575389|NCT02468193|Secondary|Plasma Concentrations of Osilodrostat (LCI699) at Week 10|Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.|Week 10, 2 hours post-dose|Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).|||ng/mL||Standard Deviation|Mean
2575390|NCT02468193|Secondary|Plasma Concentrations of Osilodrostat (LCI699) at Week 8|Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.|Week 8, 2 hours post-dose|Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).|||ng/mL||Standard Deviation|Mean
2575391|NCT02468193|Secondary|Plasma Concentrations of Osilodrostat (LCI699) at Week 6|Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.|Week 6, 2 hours post-dose|Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).|||ng/mL||Standard Deviation|Mean
2575421|NCT02468193|Primary|Percent Change in the Mean Urine Free Cortisol (mUFC) at the Individual Level at Week 12|Percent change from baseline in the mUFC at the individual patient level|Baseline, 12 weeks|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||percentage change|||Number
2575392|NCT02468193|Secondary|Plasma Concentrations of Osilodrostat (LCI699) at Week 4|Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.|Week 4, 2 hours post-dose|Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).|||ng/mL||Standard Deviation|Mean
2575393|NCT02468193|Secondary|Plasma Concentrations of Osilodrostat (LCI699) at Week 3|Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.|Week 3, 2 hours post-dose|Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).|||ng/mL||Standard Deviation|Mean
2575394|NCT02468193|Secondary|Plasma Concentrations of Osilodrostat (LCI699) at Week 2|Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.|Week 2|Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).|||ng/mL||Standard Deviation|Mean
2575395|NCT02468193|Secondary|Plasma Concentrations of Osilodrostat (LCI699) at Week 1|Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.|Week 1, 2 hours post-dose|Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).|||ng/mL||Standard Deviation|Mean
2575396|NCT02468193|Secondary|Plasma Concentrations of Osilodrostat (LCI699) at Week 0|Osilodrostat plasma concentration data at each time-point were summarized by incident dose. About a half of pre-dose concentration data were excluded from analysis due to deviation from the pre-defined acceptable time window.|Week 0|Pharmacokinetic analysis set (PAS): Consisted of all patients who received at least one dose of osilodrostat and had at least one evaluable PK concentration at any visit (post-first-dose).|||ng/mL||Standard Deviation|Mean
2575397|NCT02468193|Secondary|Total Scores in Patient-Reported Outcomes Health-related Quality of Life (QoL) as Assessed by Beck Depression Inventory II (BDI-ll) Depression Score at Individual Level|The Beck Depression Inventory II (BDI-II) is a patient reported instrument that consists of 21 items designed to assess the intensity of depression in clinical & normal patients in the preceding two weeks. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. Each of 21 items corresponds to a symptom of depression and the sum of total score will be calculated where each item has a four-point scale ranging from 0 to 3, leading to a total score from zero to 63.|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||scores on a scale|||Number
2575398|NCT02468193|Secondary|Total Scores in Patient-Reported Outcomes Health-related Quality of Life (QoL) as Assessed by Cushing QoL at Individual Level|The Cushing's Disease Health-Related Quality of Life Questionnaire (Cushing QoL) (version 1.0) was developed to evaluate quality of life in patients with Cushing's syndrome (Webb et al 2008). The Cushing QoL is comprised of 12 items that capture patient responses on seven concepts: daily activities, healing and pain, mood and self-confidence, social concerns, physical appearance, memory and concern about the future. Each questionnaire of the Cushing QOL has a scale of 1-5 where `1` corresponding to `Always` or `Very much` and `5` to `Never` or `Not at all`. The lower the score, the greater the impact on HRQoL. The score is the sum of all the item response and can range from 12 (worst) to 60 points (best).|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||scores on a scale|||Number
2575399|NCT02468193|Secondary|Percentage Change From Baseline in Cardiovascular-related Metabolic Parameter, Sitting Blood Pressure (BP) at Individual Level|Percentage change in cardiovascular-related metabolic parameter: sitting systolic BP & sitting diastolic BP, associated with Cushing's syndrome|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||percentage change|||Number
2575400|NCT02468193|Secondary|Absolute Change From Baseline in Cardiovascular-related Metabolic Parameter, Sitting Blood Pressure (BP) at Individual Level|Absolute change in cardiovascular-related metabolic parameter: sitting systolic BP & sitting diastolic BP, associated with Cushing's syndrome (CS)|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||mmHg|||Number
2575401|NCT02468193|Secondary|Percentage Change From Baseline in Cardiovascular-related Metabolic Parameter, Waist Circumference, at Individual Level|Percent change in cardiovascular-related metabolic parameter: Waist circumference, associated with Cushing's syndrome (CS)|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||percentage change|||Number
2575402|NCT02468193|Secondary|Absolute Change From Baseline in Cardiovascular-related Metabolic Parameter, Waist Circumference, at Individual Level|Absolute change in cardiovascular-related metabolic parameter: Waist circumference, associated with Cushing's syndrome (CS)|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||cm|||Number
2575403|NCT02468193|Secondary|Percentage Change From Baseline in Cardiovascular-related Metabolic Parameter, BMI, at Individual Level|Percent change in cardiovascular-related metabolic parameter: BMI, associated with Cushing's syndrome (CS)|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||percentage change|||Number
2575404|NCT02468193|Secondary|Absolute Change From Baseline in Cardiovascular-related Metabolic Parameter, BMI, at Individual Level|Absolute change in cardiovascular-related metabolic parameter: BMI, associated with Cushing's syndrome (CS)|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||kg/m^2|||Number
2575405|NCT02468193|Secondary|Percentage Change From Baseline in Cardiovascular-related Metabolic Parameters, Cholesterol, HDL Cholesterol, LDL Cholesterol & Triglycerides, at Individual Level|Percent change in cardiovascular-related metabolic parameters: cholesterol, HDL cholesterol, LDL cholesterol & triglycerides, associated with Cushing's syndrome (CS)|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||percentage change|||Number
2575406|NCT02468193|Secondary|Absolute Change From Baseline in Cardiovascular-related Metabolic Parameters, Cholesterol, HDL Cholesterol, LDL Cholesterol & Triglycerides, at Individual Level|Absolute change in cardiovascular-related metabolic parameters: cholesterol, HDL cholesterol, LDL cholesterol & triglycerides, associated with Cushing's syndrome (CS)|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||mmol/L|||Number
2575407|NCT02468193|Secondary|Percentage Change From Baseline in Cardiovascular-related Metabolic Parameter, HbA1c, at Individual Level|Percentage change in cardiovascular-related metabolic parameter HbA1c associated with Cushing's syndrome (CS)|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||percentage change|||Number
2575408|NCT02468193|Secondary|Absolute Change From Baseline in Cardiovascular-related Metabolic Parameter, HbA1c, at Individual Level|Absolute change in cardiovascular-related metabolic parameter HbA1c associated with Cushing's syndrome (CS)|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||percentage of HbA1c|||Number
2575409|NCT02468193|Secondary|Percentage Change From Baseline in Cardiovascular-related Metabolic Parameter, Fasting Glucose, at Individual Level|Percentasge change in cardiovascular-related metabolic parameter fasting glucose, associated with Cushing's syndrome (CS)|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||percentage change|||Number
2575410|NCT02468193|Secondary|Absolute Change From Baseline in Cardiovascular-related Metabolic Parameter, Fasting Glucose, at Individual Level|Absolute change in cardiovascular-related metabolic parameter fasting glucose, associated with Cushing's syndrome (CS)|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||mmol/L|||Number
2575411|NCT02468193|Secondary|Percentage Change From Baseline in Other Adrenal Steroid Hormones at Individual Levels|Percent change from baseline in several steroid hormones at individual levels: Serum 11-deoxycortisol, Testosterone|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||percentage change|||Number
2575412|NCT02468193|Secondary|Absolute Change From Baseline in Other Adrenal Steroid Hormones at Individual Levels|Absolute change from baseline in several steroid hormones at individual levels: Serum 11-deoxycortisol, Testosterone|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||nmol/L|||Number
2575413|NCT02468193|Secondary|Percentage Change From Baseline in ACTH and Other Adrenal Steroid Hormones at Individual Level|Percent change from baseline in several steroid hormones at individual levels: ACTH, Serum 11-deoxycorticosterone, Aldosterone, Estradiol|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||percentage change|||Number
2575414|NCT02468193|Secondary|Absolute Change From Baseline in ACTH and Other Adrenal Steroid Hormones at Individual Level|Absolute change from baseline in several steroid hormones at individual levels: ACTH, Serum 11-deoxycorticosterone, Aldosterone, Estradiol|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||pmol/L|||Number
2575415|NCT02468193|Secondary|Percentage Change From Baseline in Morning Serum Cortisol at Individual Level|Percentage change from baseline in morning serum cortisol at the individual patient level|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||percentage change|||Number
2575416|NCT02468193|Secondary|Absolute Change From Baseline in Morning Serum Cortisol at Individual Level|Absolute change from baseline in morning serum cortisol at the individual patient level|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||nmol/L|||Number
2575417|NCT02468193|Secondary|Percentage of Participants With mUFC Response of Complete, Partial, and Overall Response|Complete response rate = percentage of participants who had mUFC≤ ULN; Partial response rate = Percentage of participants who had mUFC>ULN and at least 50% reduction from baseline in mUFC. Overall response rate = Percentage of participants who had mUFC ≤ ULN or at least 50% reduction from baseline.|12, 24 and 48 weeks|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||Percentage of participants||95% Confidence Interval|Number
2575418|NCT02468193|Secondary|Percentage Change From Baseline in the mUFC at Week 12 (Day 85), Week 24 (Day 169) and Week 48 (Day 337)|Percent change from baseline in the mUFC|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||percentage change||Full Range|Median
2575419|NCT02468193|Secondary|Absolute Change From Baseline in the mUFC at Week 12 (Day 85), Week 24 (Day 169) and Week 48 (Day 337)|Absolute change from baseline in the mUFC|Baseline, Week 12 (day 85), Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||nmol/24hr||Full Range|Median
2575420|NCT02468193|Secondary|Percent Change From Baseline in the mUFC at Individual Patient Level at Week 24 (Day 169) and Week 48 (Day 337)|Percent change from baseline in the mUFC at the individual patient level|Baseline, Week 24 (day 169) and Week 48 (day 337)|Full Analysis Set (FAS): Comprised of all enrolled patients who received at least one dose of osilodrostat.|||percentage change|||Number
2576680|NCT02448537|Secondary|Overall Survival Rate|Overall survival is measured as the median duration of time from the start of treatment until the time of death.|from the start of treatment until death||2022-02-28|02/2022||||
2575422|NCT02468154|Secondary|Comfort Perceived by the Patient and by the Caregiver Using a Scale of 0 to 10|The scales had values from 0 to 10 where zero represented no comfort perceived and 10 the best comfort perceived|one time at cast removal (expected average of 30 days).||||units on a scale||Standard Deviation|Mean
2575423|NCT02468154|Secondary|Health Staff/Caregiver Interventions|daily number of interventions by health staff /caregiver to maintain the cast in an off-loaded position, marked on a form given daily to the family/caregiver|up to the first 2 days during hospitalization||||daily number of interventions||Standard Deviation|Mean
2575424|NCT02468154|Secondary|Numbers of Participants With Heel Pressure Sores Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.||one time at cast removal (expected average of 30 days).||||participants|||Number
2575425|NCT02468154|Primary|"Pain Score on the Numeric Rating Scale or Visual Rating Scale or Face, Legs Activity Cry Consolability According to Age Group"|All scales had values from 0 to 10 where zero represented no pain and 10 the worst possible pain|up to the first 2 days during hospitalization and at cast removal (maximum 30 days).||||units on a scale||Standard Deviation|Mean
2575426|NCT02467777|Primary|Temperature|Measured by temporal artery thermometer|Intra-Operative||||degrees celsius||Standard Deviation|Mean
2575427|NCT02467621|Secondary|A Health Economic Analysis|This has not been completed yet.|90 days||2020-01-31|01/2020||||
2575428|NCT02467621|Secondary|Number of Serious Adverse Reactions|Serious adverse reactions are: anaphylactic reactions, agranulocytosis, pancytopenia, acute hepatic failure, Steven Johnsons Syndrome and toxic epidermal necrolysis, interstitial nephritis and angioedema.|Until ICU discharge, maximum 90 days||||Participants|||Count of Participants
2575429|NCT02467621|Secondary|Percentage of Days Alive Without Organ Support|Percentage of days alive and free from mechanical ventilation, circulatory support and renal replacement therapy|Within 90 days||||percentage of days|||Number
2575430|NCT02467621|Secondary|Mortality|Data for landmark mortality 1 year after randomization.|1 year|Twenty-one patients were lost to follow-up, as compared to the primary outcome (90-day mortality): 7 patients in the PPI arm and 14 patients in the placebo arm|||Participants|||Count of Participants
2575431|NCT02467621|Secondary|Number of Participants With One or More Infectious Adverse Events|Number of participants with one or more episodes of pneumonia or clostridium difficile infection in the ICU|Until ICU discharge, maximum 90 days||||Participants|||Count of Participants
2575432|NCT02467621|Secondary|Number of Participants With Clinically Important GI Bleeding|Number of participants with one or more episodes of clinically important GI bleeding in the ICU|Until ICU discharge, maximum 90 days||||Participants|||Count of Participants
2575433|NCT02467621|Secondary|Number of Participants With Clinically Important GI Bleeding, Pneumonia, Clostridium Difficile Infection or Acute Myocardial Ischemia|Composite outcome of the number of participants with one or more of the mentioned conditions in the ICU|Until ICU discharge, maximum 90 days|Intention-to-treat|||Participants|||Count of Participants
2575434|NCT02467621|Primary|Mortality|Landmark mortality 90-days after randomization|90 days|Intention-to-treat|||Participants|||Count of Participants
2575435|NCT02467504|Secondary|Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]-2|In the last month, number of work days missed, number of work days with reduced productivity. In the last month, number of days with no household work, number of days with reduced household work productivity, number of days with hired outside help, number of days missed of family/social/leisure activities in the last month.higher scores mean a worse outcome.|week 24||||days||Inter-Quartile Range|Median
2575436|NCT02467504|Secondary|The Change From Baseline of Patient's Assessment of Arthritis Pain (PtAAP)|VAS score from 0 to 100 for Patient's Assessment of Arthritis Pain higher scores mean a worse outcome. The change from baseline of PtAAP, the minimum is -100, the maximum is 100.|week 12, week 24||||score on a scale||Inter-Quartile Range|Median
2575437|NCT02467504|Secondary|The Change From Baseline of Physician's Global Assessment of Disease Activity (PhGADA)|VAS score from 0 to 100 for Physician's Global Assessment of Disease Activity higher scores mean a worse outcome. The change from baseline, the minimum is -100, the maximum is 100.|week 12, week 24||||score on a scale||Inter-Quartile Range|Median
2575438|NCT02467504|Secondary|The Change From Baseline of Patient's Global Assessment of Disease Activity (PtGADA)|VAS score from 0 to 100 for Patient's Global Assessment of Disease Activity Higher scores mean a worse outcome. The change from baseline of PtGADA, the minimum is -100, the maximum is 100. Higher scores mean a worse outcome.|week 12, week 24||||score on a scale||Inter-Quartile Range|Median
2575439|NCT02467504|Secondary|C Reactive Protein (CRP)||week 12, week 24||||mg/L||Standard Deviation|Mean
2575440|NCT02467504|Secondary|Erythrocyte Sedimentation Rate (ESR)||week 12, week 24||||millimeter/hour||Standard Deviation|Mean
2575441|NCT02467504|Secondary|Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]|The Arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). The Arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).higher scores mean a worse outcome.|week 24||||units on a scale||Inter-Quartile Range|Median
2575442|NCT02467504|Secondary|The Scores of SF-36 Quetionnaire|Score ranging from 0 to 100 with higher scores a better outcome.|week 12, week 24||||score on a scale||Inter-Quartile Range|Median
2575443|NCT02467504|Secondary|The Change From Baseline of a Health Assessment Questionnaire- Disability Index (HAQ-DI)|"The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. The total score ranges from 0 to 3 with lower scores meaning lower disability.~The change from baseline of HAQ-DI, minimum is -3, the maximum is 3. higher scores mean a worse outcome."|week 12, week 24||||score on a scale||Inter-Quartile Range|Median
2575444|NCT02467504|Secondary|Percentage of Participants Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice|The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as:Tender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1 and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1.|week 12, week 24||||Participants|||Count of Participants
2576990|NCT02445911|Primary|Number of Participants With One or More Treatment-Emergent Adverse Events||Baseline to Day 29|PD population includes all 81 participants|||participants|||Number
2575445|NCT02467504|Secondary|Percentage of Participants Meeting the American College of Rheumatology 70% Response Criteria|The assessments are based on a 70% or greater improvement from Baseline in the number of tender joints, a 70%, or more improvement in the number of swollen joints, and a 70% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|week 12, week 24||||Participants|||Count of Participants
2575446|NCT02467504|Secondary|Percentage of Participants Meeting the American College of Rheumatology 50% Response Criteria|The assessments are based on a 50% or greater improvement from Baseline in the number of tender joints, a 50%, or more improvement in the number of swollen joints, and a 50% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|week 12, week 24||||Participants|||Count of Participants
2575447|NCT02467504|Secondary|Percentage of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response|"Good response is defined as: DAS28-ESR ≤ 3.2 and decrease from Baseline by > 1.2.~moderate response is defined as achievement of one of the following: DAS28-ESR ≤ 3.2 and decrease from Baseline > 0.6 and ≤ 1.2 DAS28-ESR > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6 DAS28-ESR > 5.1 and decrease from Baseline >1.2."|week 12, week 24||||Participants|||Count of Participants
2575448|NCT02467504|Secondary|Percentage of Participants Achieving DAS28 Low Disease Activity.|Low disease activity is defined by a disease activity score (28 joint) calculated using the erythrocyte sedimentation rate (DAS28-ESR) of less than 3.2|week 12, week 24||||Participants|||Count of Participants
2575449|NCT02467504|Secondary|Percentage of CD4+ Treg Cells|analysis regulatory CD4+ T(Treg) cells before and during IL-2 treatment. P values<0.05 are considered statistically significant.|week 12, week 24||||percentage of CD4+ T cells||Full Range|Mean
2575450|NCT02467504|Secondary|Number of Participants With Adverse Events|adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event, drug-induced liver and kidney damage.|Up to week 24||||Participants|||Count of Participants
2575451|NCT02467504|Primary|The Change From Baseline of Simplified Disease Activity Index (SDAI)|"Simplified Disease Activity Index(SDAI). the minimum is 0, the maximum is 96. higher scores mean worse outcome.~The change from baseline of SDAI. the minimum is -96, the maximum is 96. higher scores mean worse outcome."|week 12, week 24||||score on a scale||Inter-Quartile Range|Median
2575452|NCT02467504|Primary|The Change From Baseline of Clinical Disease Activity Index (CDAI)|"Clinical Disease Activity Index(CDAI), the minimum is 0, the maximum is 76. higher scores mean a worse outcome.~The change of from baseline of CDAI, the minimum is -76, the maximum is 76. higher scores mean a worse outcome."|week 12, week 24||||score on a scale||Inter-Quartile Range|Median
2575453|NCT02467504|Primary|Percentage of Participants Meeting the American College of Rheumatology 20% Response Criteria|The assessments are based on a 20% or greater improvement from Baseline in the number of tender joints, a 20%, or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|week 12, week 24||||Participants|||Count of Participants
2575454|NCT02467504|Primary|Percentage of Participants Achieving DAS28 Remission.|DAS 28 remission is defined by a disease activity score (28 joint) calculated using the erythrocyte sedimentation rate (DAS28-ESR) of less than 2.6|week 24||||Participants|||Count of Participants
2575455|NCT02467491|Secondary|Change From 4 Weeks (End of Intervention) to 3 Months After the End of the Intervention in the Short Physical Performance Battery Test|Physical performance will be assessed using the Short Physical Performance Battery test (SPPB). The score for this test is 0 meaning the worst performance to 12 meaning the best performance.|Change in 4 weeks to 3 months||||units on a scale||Standard Deviation|Mean
2575456|NCT02467491|Secondary|Change From Baseline to 4 Weeks in the Short Physical Performance Battery Test|Physical performance will be assessed using the Short Physical Performance Battery test (SPPB). The score for this test is 0 meaning the worst performance to 12 meaning the best performance.|Change in baseline to 4 weeks||||units on a scale||Standard Deviation|Mean
2575457|NCT02467491|Primary|Global Appreciation Score|"The global appreciation score is a measure of feasibility.~This score will be derived from each participant's answer to the first question of a 9-item acceptability questionnaire. The second question of the questionnaire is :How much did you like Jintronix?, participants' answer may be:~I didn't like it (0 point)~A little (1 points)~Moderate (2 points)~A lot (3 points). The global appreciation score is the sum of the points obtained by each participants.~The global appreciation score for 12 participants may range from 0 (no appreciation) to 36 (a lot of appreciation).~In order to say that Jintronix is feasible we expected a global appreciation score for 12 participant after 4 weeks of intervention to be > 24."|4 weeks||||units on a scale|||Number
2575458|NCT02467491|Primary|Global Difficulty Score|"The global difficulty score was another measure of acceptability.~The global difficulty score will be derived from each participant's answer to the second question of a 9-item feasibility questionnaire. The second question of the questionnaire is :How difficult did you find the Jintronix?, participants' answer may be:~Very difficult (3 point)~Quite difficult (2 points)~Not at all (1 points)~No difficulty (0 points). This means that the global difficulty score for 12 participants may range from 0 (no difficult) to 36 (very difficult).~We expected to find a global difficulty score < to 15 in order to say that Jintronix was acceptable."|4 weeks||||units on a scale|||Number
2575490|NCT02466230|Other Pre-specified|Gamma-amino-butyric Acid Level Measured by Magnetic Resonance Spectroscopy|Percent change in medial prefrontal gamma-amino-butyric acid level|Baseline to immediately after the final rTMS treatment (5 weeks)|||||||
2575575|NCT02464917|Secondary|Number of Newborns Requiring Intubation|needing supplemental oxygen for the newborn through breathing device|completed once infant is discharged home; anticipate 1-4 days||||Participants|||Count of Participants
2601640|NCT02150954|Secondary|Neonatal Outcome: Birthweight||at time of birth (0 to 1 hour)||||gram||Standard Deviation|Mean
2575459|NCT02467491|Primary|Total Average Time in Performing Exercises With Jintronix.|"Each participant has to perform the exercise program with Jintronix for 30 minutes per session, for 2 times/week for a total of 4 weeks.~This means that each participant has to be able to perform a maximum of 240 minutes of exercises for 4 weeks.~Jintronix calculated automatically the time (minutes) in performing the exercises for each participant at the end of the 4 weeks of intervention.~As a measure of acceptability we calculated the total average time in performing the exercises for the 12 participants for 4 weeks by summing the minutes in performing the exercises for each participants for 4 week and dividing it for 12.~We expected to find an average total time in performing the exercises for 12 participants > 192 minutes (3.2 hours) out of a total of 240 minutes (4 hours) in order to say that Jintronix was acceptable."|4 weeks||||minutes||Standard Deviation|Mean
2575460|NCT02467491|Primary|Quality of Movements' Total Average Score|"The quality of movements' score is a measure of feasibility. The quality of movement's score is automatically calculated by Jintronix for each participant at the end of the intervention program with Jintronix.~A quality of movement's score of 100% means that the participant performed the exercise perfectly.~To calculate the quality of movements' total average score for the Group (made of 12 participants), we summed the quality of movements' score for each participants and divided it for 12. We expected to find a total average quality movements' score>80% in order to say that Jintronix was feasible."|4 weeks||||percentage of quality of movements||Standard Deviation|Mean
2575461|NCT02467387|Secondary|Change in LVEF From Baseline to Day 90 Post-initial Infusion.|The secondary efficacy endpoint was the change in LVEF from baseline to Day 90 post-initial infusion. Participants with data available at each time point.|Baseline to Day 90|The secondary efficacy endpoint according to the protocol was the change in LVEF from baseline to Day 90 post-initial infusion.|||percentage of ejection volume||Standard Deviation|Mean
2575462|NCT02467387|Primary|Safety Will be Evaluated by Number of AE|As identified in the SAP, the safety analysis was the primary objective and was evaluated by the number of AEs|Total AEs and SAEs within 450 days post-infusion|All 22 participants that received itMSC treatment were included. All adverse events are divided into serious and non-serious.|||number of events|||Number
2575463|NCT02467179|Secondary|Fluoroscopy Time Measurements|Determine fluoroscopy time to reach CTI block.|at time of ablation procedure||||minutes||Standard Deviation|Mean
2575464|NCT02467179|Primary|Contact Force Through Measurement of Force-time Integral (FTI)|Determination of the average total contact force (measured in gs) achieved during each ablation lesion using the Carto Mapping System|At time of the ablation procedure, which typically lasts 30-60 minutes||||gm/s||Standard Deviation|Mean
2575465|NCT02467075|Secondary|Mortality Rate - 30 Day|Number of subjects who died within 30 days of entry into the study.|30 days||||participants|||Number
2575466|NCT02467075|Secondary|30-day Readmission|Number of times a subject is readmitted within 30 days of study recruitment|30 days||||Number of admissions||Standard Deviation|Mean
2575467|NCT02467075|Secondary|Hospital Length of Stay|Subject's hospital length of stay in days|Duration of hospital stay (assessed from date of randomization up to 30 days)||||days|days|Standard Deviation|Mean
2575468|NCT02467075|Secondary|Subjects Requiring Renal Replacement Therapy (Kidney Transplant or Dialysis)|Number of subjects that require renal (kidney) replacement therapy, such as a kidney transplant or dialysis within 30 days of study participation.|30 days||||Participants|||Count of Participants
2575469|NCT02467075|Secondary|Subjects With AKI (Acute Kidney Injury), Stage 1 or Other Definition|Stage I AKI, traditional CIN definitions or other definitions of AKI (acute kidney injury) at lower levels of severity|48-72 hours||||Participants|||Count of Participants
2575470|NCT02467075|Primary|Participants With Stage II AKI (Acute Kidney Injury)|Participants who had Stage II AKI. This is measured by comparing an initial blood creatinine level with the level at 48 hours. Creatine is a chemical waste product that passes through the kidneys. Creatinine levels reflect how well the kidneys are working.|48 hours|Participants with State II AKI (Acute Kidney Injury)|||Participants|||Count of Participants
2575471|NCT02466958|Secondary|Geriatric Depression (GDS) Scores|The GDS has a total of 30 items with response options [Yes/No]. Total score range is [0-30]. Higher scores represent more severe difficulties.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2575472|NCT02466958|Secondary|Clinical Global Impression Scale (CGI) Scores|7-Point Likert Scale [1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse].|Week 12 reported||||units on a scale||Standard Deviation|Mean
2575473|NCT02466958|Primary|Hamilton Depression Rating Scale (HDRS) Scores 24|This measure includes 24 items. Response options vary item to item and include the following ranges: [0-2], [0-3], and [0-4]. A score of 0 suggests absence of symptoms and/or difficulties and higher scores represent more severe difficulties. Possible overall score range [0-74], higher scores representing more severe difficulties.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2575474|NCT02466659|Other Pre-specified|Amblyopia|It is defined when visual acuity between two eyes equal or over 2 logMAR lines.|3 Months||||Participants|||Count of Participants
2575475|NCT02466659|Primary|Change in Composite Measure of IXT Control Score|"IXT control score: referring to the Pediatric eye disease investigator group (PEDIG).~PEDIG scale of control for IXT 1-5 is defined as the following:~5 = Constant exotropia 4 = exotropia > 50% of the 30-sec period before dissociation 3 = exotropia < 50% of the 30-sec period before dissociation 2 = No exotropia unless dissociated, recovers in > 5 sec~1 = No exotropia unless dissociated, recovers in 1-5 sec 0 = No exotropia unless dissociated, recovers in < 1 sec (phoria) Not Applicable = No exotropia present"|12 weeks; 24 weeks||||units on a scale||Standard Deviation|Mean
2575485|NCT02466412|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of CHTP 1.1 M and mCC|"T0 = start of single product use.~Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares (LS) means are provided."|Day 3: blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0.|"The PK population consisted of 47 subjects.~1 subject was excluded from the PK population (sequence CHTP 1.1 M then mCC) due to all plasma nicotine concentration measurements being below the quantification limit for both CHTP 1.1 M and mCC."|||ng/mL||95% Confidence Interval|Least Squares Mean
2577312|NCT02441218|Secondary|Hospitalisation for Any Cause||From the date of randomisation to the date of first documented hospitalisation, up to 42 months||||participants|||Number
2575476|NCT02466555|Secondary|Change From Baseline in Percentage of Attended Clinic Appointments During the One-year Study Period.|Adherence is the extent to which a person's behavior coincides with medical or prescribed health advice (Julius, 2009). Adherence will be measured regularly throughout the study via medical record review. In order to assess adherence, the following data will be obtained from the medical record on each patient throughout the study period: 1) Total scheduled clinic visits with Adult Sickle Cell Disease Clinic, 2) Number of missed clinic visits to Adult Sickle Cell Disease Clinic due to no show, cancellation, or rescheduling. Adherence to clinic appointments is calculated as total number of attended clinic visits divided by total number of scheduled clinic visits (including no shows) multiplied by 100. The reported adherence percentage is the difference between percentage of visits attended during the 12 months study period minus the percentage of visits attended during the 12 months before the study period.|Baseline (T1), 12 months (T5)|All participants who participated in the music therapy intervention.|||percentage of appointments attended||Standard Deviation|Mean
2575477|NCT02466555|Primary|Change (T1-T5) From Baseline in Scores on the Seidman Sickle Cell Knowledge Quiz|Sickle Cell Disease knowledge will be measured using the Seidman Sickle Cell Knowledge Quiz developed specifically for this study. The Seidman Sickle Cell Knowledge Quiz is adapted from questions from the Sickle Cell Disease Knowledge Test (Kaslow et al., 2000) and How Much Do I Know About Sickle Cell Disease (Baskin, Collins, Kaslow, & Hsu, 2002). The total score is reported with a minimum score of 0 and a maximum score of 12. Higher scores represent greater knowledge of sickle cell disease.|Baseline (T1), 3 months (T2), 6 months (T3), 9 months (T4), 12 months (T5), change (T1-T5) in least square mean from T1 to T5 reported|All participants who participated in the music therapy intervention.|||score on a scale||95% Confidence Interval|Least Squares Mean
2575478|NCT02466555|Primary|Change (T1-T5) From Baseline in Scores on the Wake Forest Trust in the Medical Profession Scale|Patient trust is the optimistic acceptance of a vulnerable situation in which the patient believes the health-care provider will take care of the patient's interests (Dugan, Trachtenberg, & Hall, 2005).The Wake Forest Trust in the Medical Profession Scale is a five-item scale in which respondents express their level of agreement with the following statements: 1) Sometimes doctors care more about what is convenient for them than about their patients' medical needs (reverse coded); 2) Doctors are extremely thorough and careful; 3) You completely trust doctors' decisions about which medical treatments are best; 4) A doctor would never mislead you about anything; 5) All in all, you trust your doctor completely. Responses are summed and scores are on a 5-25 scale, with higher values indicating greater trust.|Baseline (T1), 3 months (T2), 6 months (T3), 9 months (T4), 12 months (T5), change (T1-T5) in least square mean from T1 to T5 reported|All participants who participated in the music therapy intervention.|||score on a scale||95% Confidence Interval|Least Squares Mean
2575479|NCT02466555|Primary|Change (T1 - T5) From Baseline in Scores on the Sickle Cell Self-Efficacy Scale (SCSES)|Self-efficacy is the conviction that one can successfully execute the behavior required to produce the outcome. (Bandura, 1997, p. 193). The SCSES is a nine-item Likert scale originally developed for adults with sickle cell disease (Edwards, Telfair, Cecil, & Lenoci, 2000) and revised in a follow up study by Clay and Telfair (2007) for adolescents using a sample of 131 individuals age 11-19. The total score is reported with a minimum score of 9 and a maximum score of 45. Higher scores represent higher/better self-efficacy.|Baseline (T1), 3 months (T2), 6 months (T3), 9 months (T4), 12 months (T5), change (T1-T5) in least square mean from T1 to T5 reported|All participants who participated in the music therapy intervention.|||score on a scale||95% Confidence Interval|Least Squares Mean
2575480|NCT02466516|Primary|Number of Participants Who Prematurely Discontinued Study Drug or Study Due to Adverse Events||Baseline up to follow up visit (Week 28)|Participants in the Safety Analysis Set were analyzed.|||Participants|||Count of Participants
2575481|NCT02466516|Primary|Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory Abnormality|Treatment-emergent events began on or after the first dosing date up to 30 days after the last dosing date or led to premature discontinuation of study drug. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.|Baseline up to last dose plus 30 days (up to Week 28)|Safety Analysis Set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2575482|NCT02466425|Secondary|Clinical Global Impression of Improvement (CGI-I) at Visit 6 (Week 4)|CGI-I was performed to rate the severity of a participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).|Visit 6 (Week 4)|FAS with number of participants evaluable for this outcome.|||Units on a scale||Standard Deviation|Mean
2575483|NCT02466425|Primary|Change From Baseline in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Visit 6 (Week 4)|The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD based on diagnostic and statistical manual of mental disorders, fourth edition - text revision (DSM-IV-TR) criteria. Each item is scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even-numbered items 2-18) and inattentiveness (odd-numbered items 1-17). Higher score = more severe symptoms.|Baseline, Visit 6 (Week 4)|Full-analysis set (FAS) consisted of the safety set who had at least 1 post-dose ADHD-RS-IV total score assessment. FAS with number of participants evaluable for this outcome.|||Units on a scale||Standard Deviation|Mean
2575484|NCT02466412|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of CHTP 1.1 M and mCC|"T0 = start of single product use.~Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares means are provided."|Day 3: blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0.|"The PK population consisted of 47 subjects.~1 subject was excluded from the PK population (sequence CHTP 1.1 M then mCC) due to all plasma nicotine concentration measurements being below the quantification limit for both CHTP 1.1 M and mCC."|||h*ng/mL||95% Confidence Interval|Least Squares Mean
2575486|NCT02466230|Other Pre-specified|Functional Connectivity Measured by Functional Magnetic Resonance Imaging|Percent change in medial prefrontal average functional connectivity|Baseline to immediately after the final rTMS treatment (5 weeks)|||||||
2615592|NCT01999192|Secondary|ACR Score||up to 48 weeks|||||||
2575491|NCT02466230|Secondary|Depression Severity Measured by the Public Health Questionnaire-9|Self-rated scale of symptoms of depression. Nine items with a maximum score of 27. Higher score means more severe depression (0-4 = None; 5-9 = Mild; 10-14 = Moderate; 15-19 = Severe; 20 and higher = Very Severe).|Change in score in Public Health Questionnaire-9 from baseline to immediately after the final rTMS treatment (5 weeks)|All 28 subjects completed the study but two subjects did not complete the final PHQ-9 assessment.|||units on a scale||Standard Deviation|Mean
2575492|NCT02466230|Primary|Depression Severity Measured by the Hamilton Depression Rating Scale (24-Item)|The Hamilton Depression Rating Scale is 24 items with total scores ranging from 0-76. Higher scores indicate greater severity of depression. (0-7 = None; 8-13 = Mild; 14-18 = Moderate; 19-23 = Severe; 23 and higher = very severe). Total scores are reported with no subscales.|Change in score on Hamilton Depression Rating Scale from baseline to immediately after the final rTMS treatment (5 weeks)||||units on a scale||Standard Deviation|Mean
2575493|NCT02466087|Secondary|Change in Headaches While Taking Supplements|"Change in headaches compared to normal during the 6 weeks on supplements. Change was calculated from 2 time points-start of supplements and end of supplements.~Change was recorded as 0, None (same)~Mild~Moderate~Severe (worse)"|12 weeks|headaches|||score on a scale||95% Confidence Interval|Mean
2575494|NCT02466087|Secondary|Generalized Anxiety Disorder 7 Item Questionnaire|"Change in score from week 1 to week 6 and week 7 to 12 (difference in differences)~GAD-7 score has been shown to be a valid indication of anxiety symptoms. The GAD-7 score can range from 0 to 21, with the following severity scores: 0-4 None; 5-9 Mild; 10-14 Moderate; 15-21 Severe."|12 weeks||||scores on a scale||95% Confidence Interval|Mean
2575495|NCT02466087|Primary|Patient Health Questionnaire-9|"Change in score from week 1 to week 6 and week 7 to week 12 (difference in differences)~The Patient Health Questionnaire-9 Item is a validated questionnaire with high sensitivity and specificity for the diagnosis of depression. The PHQ-9 score can range from 0 to 27, with the following severity scores: 0-4 None; 5-9 Mild; 10-14 Moderate; 15-19 Moderate to Severe; 20-27 Severe."|12 weeks|Number of participants with analyzable data.|||score on a scale||95% Confidence Interval|Mean
2575496|NCT02465931|Primary|Decisional Capacity - Understanding Score|MacArthur Decisional Capacity - understanding score, range 0 (no understanding) to 26 (perfect understanding) A summary score was calculated, ranging from 0-26. Scores were then translated into a percentage based on the number of questions answered. A score of 100% indicates that the participant answered each understanding question correctly on the first attempt.|Day 1, immediately following presentation of the material in the intervention or comparison condition||||percentage of understanding||Standard Deviation|Mean
2575497|NCT02465866|Primary|Percentage of AUCinf [AUCExtrap (%)] Based on Extrapolation|"Calculated as:~AUCExtrap (%) = (AUC0-inf - AUC0-last)/AUC0-inf *100"|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population|||Percentage of AUCExtrap||Standard Deviation|Mean
2575498|NCT02465866|Primary|Area Under the Concentration-time (AUCinf) Curve From Time-zero Extrapolated to Infinity|"Calculated as:~AUCinf = AUClast + Clast/λz"|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population|||h*ng/mL||Standard Deviation|Mean
2575499|NCT02465866|Primary|Area Under the Plasma Concentration-time (AUClast) Curve From Time-zero to the Time of the Last Quantifiable Concentration|Calculated using the linear trapezoidal rule|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population|||h*ng/mL||Standard Deviation|Mean
2575500|NCT02465866|Primary|AUC0-4.0 for Hydrocodone and Promethazine|AUC0-4.0 measured by Linear Trapezoidal with Linear Interpolation method.|0 (pre-dose) to 4 hours post-dose|ITT population|||h*ng/mL||Standard Deviation|Mean
2575501|NCT02465866|Primary|AUC0-2.0 for Hydrocodone and Promethazine|AUC0-2.0 measured by Linear Trapezoidal with Linear Interpolation method.|0 (pre-dose) to 2 hours post-dose|ITT population|||h*ng/mL||Standard Deviation|Mean
2575502|NCT02465866|Primary|AUC0-1.5 for Hydrocodone and Promethazine|AUC0-1.5 measured by Linear Trapezoidal with Linear Interpolation method.|0 (pre-dose) to 1.5 hours post-dose|ITT population|||h*ng/mL||Standard Deviation|Mean
2575503|NCT02465866|Primary|AUC0-1.0 for Hydrocodone and Promethazine|AUC0-1.0 measured by Linear Trapezoidal with Linear Interpolation method.|0 (pre-dose) to 1.0 hours post-dose|ITT population|||h*ng/mL||Standard Deviation|Mean
2575504|NCT02465866|Primary|AUC0-0.75 for Hydrocodone and Promethazine|AUC0-0.75 measured by Linear Trapezoidal with Linear Interpolation method.|0 (Pre-dose) to 0.75 hours post-dose|ITT population|||h*ng/mL||Standard Deviation|Mean
2575505|NCT02465866|Primary|AUC0-0.50 for Hydrocodone and Promethazine|AUC0-0.50 measured by Linear Trapezoidal with Linear Interpolation method.|0 (pre-dose) to 0.5 hours post-dose|ITT population|||h*ng/mL||Standard Deviation|Mean
2575506|NCT02465866|Primary|Area Under the Plasma Concentration-time Curve (AUC0-0.25) for Hydrocodone and Promethazine|AUC0-0.25 measured by Linear Trapezoidal with Linear Interpolation method.|0 (pre-dose) to 0.25 hours post-dose|ITT population|||h*ng/mL||Standard Deviation|Mean
2575507|NCT02465866|Primary|Observed Terminal Elimination Half-life (T1/2)|Calculated as: T1/2 = ln(2)/λz|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population|||hours||Standard Deviation|Mean
2575508|NCT02465866|Primary|Observed Elimination Rate Constant (λz)|Estimated by linear regression through at least three data points in the terminal phase of the log concentration-time profile|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population|||h-1||Standard Deviation|Mean
2575509|NCT02465866|Primary|Time of the Last Quantifiable Concentration (Tlast)||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population|||Hours||Standard Deviation|Mean
2575510|NCT02465866|Primary|Last Quantifiable Drug Concentration (Clast) Determined Directly From Individual Concentration-time Data||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population|||ng/mL||Standard Deviation|Mean
2575511|NCT02465866|Primary|Time to Reach Maximum Concentration (Tmax)||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|ITT population|||hours||Standard Deviation|Mean
2575576|NCT02464917|Secondary|Number of Newborns With Intraventricular Hemorrhage|condition that causes bleeding within the brain typically affecting premature babies|completed once infant is discharged home; anticipate 1-4 days||||Participants|||Count of Participants
2575512|NCT02465866|Primary|Maximum Drug Concentration (Cmax) in Plasma Determined Directly From Individual Concentration-time Data|Cmax of CL-108 and Vicoprofen + Ultracet + Phenergan were measured in the plasma (the liquid component of the blood in which the blood cells are suspended) in samples collected up to 48 hours post-dose.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, and 48 hours post-dose|Intended to treat (ITT) population|||ng/mL||Standard Deviation|Mean
2575513|NCT02465632|Primary|Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)|The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated.|Baseline and 10 Weeks||||Percentage change from baseline||Standard Deviation|Mean
2575514|NCT02465632|Primary|Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)|The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated.|Baseline and 10 Weeks||||percentage change from baseline||Standard Deviation|Mean
2575515|NCT02465528|Secondary|Percent of Participant Deaths During Treatment and Follow-up|Deaths due to any cause during treatment and 30 day follow-up|Baseline up to approximately 84 weeks|There were no deaths in the ALCL and IMT arms|||percent of participants|||Number
2575516|NCT02465528|Secondary|Progression Free Survival (PFS) Per Investigator Assessments|PFS is defined as the time from the date of first dose of ceritinib to the date of first documented disease progression or death from any cause|Baseline, every 8 weeks until disease progression or death from any cause, assessed for up to approximately 84 weeks|no participants met definition of PFS|||weeks||95% Confidence Interval|Median
2575517|NCT02465528|Secondary|Time to Response (TTR) Per Investigator Assessment|TTR is defined as the time from date of the first dose to date of first documented response (CR or PR)|Baseline, every 8 weeks until disease progression or end of treatment, whichever came first, assessed up to approximately 84 weeks||||weeks||95% Confidence Interval|Median
2575518|NCT02465528|Secondary|Duration of Response (DOR) Per Investigator Assessment|DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause|Baseline, every 8 weeks until disease progression or end of treatment, whichever came first, assessed up to approximately 84 weeks||||weeks||95% Confidence Interval|Median
2575519|NCT02465528|Secondary|Overall Response Rate (ORR) Per Investigator Assessment|ORR is defined as the percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local assessment according to RECIST 1.1, RANO or Cheson hematological criteria.|Baseline, every 8 weeks until disease progression or end of treatment, whichever came first assessed up to approximately 84 weeks||||percentage of participants||95% Confidence Interval|Number
2575520|NCT02465528|Primary|Disease Control Rate (DCR) Based on Investigator Assessments for Participants With at Least 16 Weeks of Treatment|The DCR is defined as the percentage of patients with complete response (CR), partial response (PR) or stable disease (SD) at 16 weeks from the start of ceritinib treatment. The assessment criteria are: Solid Tumors (RECIST 1.1., Response Evaluation Criteria in Solid Tumors); GBM (RECIST 1.1 and RANO, Response Evaluation in Neuro-Oncology); Hematologic tumors (Cheson).|Baseline up to approximately 16 weeks||||percentage of participants||95% Confidence Interval|Number
2575521|NCT02465515|Secondary|Change From Baseline in Heart Rate|Heart rate was measured with the participant in a semi-recumbent or seated position after at least a 5-minute rest period. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.|Baseline and Months 8, 16, 24 and end of study (up to 2.7 years)|Safety Population. Only those participants with a value at Baseline and specified visit were analyzed (represented n=X in category titles)|||Beats per minute||Standard Deviation|Mean
2575522|NCT02465515|Secondary|Change From Baseline in Blood Pressure|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were taken with the participant in a semi-recumbent or seated position after at least a 5-minute rest period. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.|Baseline and Months 8,16,24 and end of study (up to 2.7 years)|Safety Population. Only those participants with a value at Baseline and specified visit were analyzed (represented n=X in category titles)|||Millimeter of mercury||Standard Deviation|Mean
2575523|NCT02465515|Secondary|Change in Estimated Glomerular Filtration Rate (eGFR) Calculated Using Modification of Diet in Renal Disease (MDRD) Formula|Blood samples were collected for the measurement of serum creatinine. Serum creatinine values were used to calculate eGFR using the MDRD formula, eGFR=175 x (serum creatinine)^-1.154 x (Age)^-0.203 x (0.742 if female) x (1.212 if African American). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. Change from Baseline in eGFR using Baseline data from Local or Central Laboratory, and post-Baseline Central Laboratory data for the on-treatment time period is presented.|Baseline and Months 8 and 16|Safety Population. Only those participants with a value at Baseline and specified visit were analyzed (represented by n=X in category titles)|||Milliliter/minute/1.73 meter square||Standard Error|Least Squares Mean
2575524|NCT02465515|Secondary|Number of Participants With AEs of Special Interest|The protocol defined AEs of special interest included: development of thyroid cancer; hematologic malignancy; pancreatic cancer; pancreatitis (investigator reported and pancreatitis positively adjudicated by the Pancreatic Adjudication Committee [PAC]); investigational product injection site reactions; immunological reactions; severe hypoglycemic events; hepatic events; hepatic enzyme elevations (including gamma glutamyl transferase [GGT]); serious gastrointestinal (GI) events; appendicitis; atrial fibrillation/flutter; pneumonia; worsening renal function and diabetic retinopathy. The number of participants with on-therapy AEs of special interest is reported.|Up to 2.7 years|Safety Population|||Participants|||Count of Participants
2575525|NCT02465515|Secondary|Number of Participants With Adverse Events (AEs) Leading to Discontinuation of Investigational Product (AELD)|The number of participants with on-therapy AEs leading to discontinuation of investigational product is reported.|Up to 2.7 years|Safety Population|||Participants|||Count of Participants
2575544|NCT02465489|Primary|Tmax for Serum Deferiprone|Time of maximum observed serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.|The pharmacokinetic population included subjects who provided evaluable data for at least two study periods|||Hour||Standard Deviation|Mean
2575526|NCT02465515|Secondary|Number of Participants With Non-fatal Serious Adverse Events (SAEs)|SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before; is associated with liver injury and impaired liver function. Number of participants with on-therapy non-fatal SAEs are presented. Safety Population comprised of all randomized participants who received at least one dose of study treatment.|Up to 2.7 years|Safety Population|||Participants|||Count of Participants
2575527|NCT02465515|Secondary|Time to Death|Time to death was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants who died/endpoint person-years) is presented along with 95% confidence interval. Endpoint person-years=(cumulative total time to event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the Vital Status follow-up time period.|Median of 1.73 years for the Vital Status follow-up time period|ITT Population|||Events per 100 person years||95% Confidence Interval|Number
2575528|NCT02465515|Secondary|Change From Baseline in EuroQol- 5 Dimension (EQ-5D) Visual Analogue Scale (VAS) Score|The EQ-5D is a standardized instrument used to evaluate generic health-related quality of life, comprising 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It provides a simple descriptive profile and a single index value for health status. The EQ-5D self-reported questionnaire includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.|Baseline and Months 8 and 16|ITT Population. Only those participants with value at Baseline and at the specified visit is presented (represented by n=X in category titles)|||Scores on a scale||Standard Error|Least Squares Mean
2575529|NCT02465515|Secondary|Change From Baseline in Treatment Related Impact Measures-Diabetes (TRIM-D) Total Score|The TRIM-D is a 28 item treatment satisfaction measure with 5 domains assessing Treatment Burden, Daily Life, Diabetes Management, Compliance and Psychological Health. The raw score ranges for each subscale were: treatment burden (6 to 30), daily life (5 to 25), diabetes management (5 to 25), compliance (4 to 20) and psychological health (8 to 40), higher scores indicating better health state. Total raw score was determined by summing the raw scores for each of the subscales and the total score (transformed) was determined as [(raw score minus lowest possible raw score)/possible raw score range] x100. The possible total (transformed) score range is 0−100, where higher scores indicated better health state. Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.|Baseline and Months 8 and 16|ITT Population. Only those participants with value at Baseline and at the specified visit is presented (represented by n=X in category titles)|||Scores on a scale||Standard Error|Least Squares Mean
2575530|NCT02465515|Secondary|Change From Baseline in Body Weight|Change from Baseline in body weight was analyzed using mixed model repeated measures including observed case data (does not impute any missing data). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value.|Baseline and Months 8 and 16|ITT Population. Only those participants with value at Baseline and at the specified visit is presented (represented by n=X in category titles)|||Kilograms||Standard Error|Least Squares Mean
2575531|NCT02465515|Secondary|Change From Baseline in HbA1c|Change from Baseline in HbA1c was analyzed using mixed model repeated measures (MMRM) including observed case data (does not impute any missing data). Baseline is the last non-missing value assessed on or before treatment start date. Change from Baseline is the value at specified time point minus the Baseline value. Change from Baseline in HbA1c using Baseline data from Local or Central Laboratory, and post-Baseline Central Laboratory data is presented.|Baseline and Months 8 and 16|ITT Population. Only those participants with value at Baseline and at the specified visit is presented (represented by n=X in category titles)|||Percentage of HbA1c||Standard Error|Least Squares Mean
2575532|NCT02465515|Secondary|Time to First Occurrence of a Clinically Important Microvascular Event|Clinically important microvascular events were defined as the following: need for renal transplant or dialysis, new diabetes-related blindness, and procedures (laser photocoagulation or anti-vascular endothelial growth factor treatment or vitrectomy for diabetic retinopathy/eye disease). Time to first occurrence of a clinically important microvascular event was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period.|Up to 2.7 years|ITT Population|||Events per 100 person years||95% Confidence Interval|Number
2575533|NCT02465515|Secondary|Percentage of Participants Achieving Composite Metabolic Endpoint|Percentage of participants achieving composite metabolic endpoint defined as the percentage of participants achieving glycemic control (glycated hemoglobin [HbA1c] <=7% ) with no severe hypoglycemic incidents and weight gain < 5%. Final Assessment is the latest post-Baseline assessment of both HbA1c and weight.|Months 8, 16, 24 and final assessment (up to 2.7 years)|ITT Population. Only those participants with HbA1c and weight values at Baseline and at the specified visits were analyzed (represented by n=X in category titles)|||Percentage of participants|||Number
2575543|NCT02465489|Primary|AUC0-∞for Serum Deferiprone|Area under the serum concentration time curve extrapolated to infinity. Blood samples will be collected pre-dose and over a 24-hour interval post-dose.|Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.|The pharmacokinetic population included subjects who provided evaluable data for at least two study periods|||ug*h/mL||Standard Deviation|Mean
2575572|NCT02465073|Primary|The Percentage of Patients Who Had a 50% or Greater Wound Size Volume Reduction After 4 Weeks of Treatment With the Next Science Wound Gel, as Compared to Wounds Treated With Standard of Care||Percentage after 4 weeks||||percentage of participants|||Number
2575534|NCT02465515|Secondary|Time to Initiation of Prandial Insulin in Those Participants on Basal Insulin at Study Start|Time to initiation of prandial insulin in those participants on basal insulin at study start was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period. The analysis was performed on Basal Insulin Population which comprised of participants in the ITT Population who were on basal insulin but not on other insulin at Baseline (i.e., will not include a participant on a mixed insulin or on a prandial-only insulin).|Up to 2.7 years|Basal Insulin Population|||Events per 100 person years||95% Confidence Interval|Number
2575535|NCT02465515|Secondary|Time to Initiation of Insulin of More Than 3 Months Duration for Those Participants Not Treated With Insulin at Study Start|Time to initiation of insulin of more than 3 months duration in participants not treated with insulin at study start was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the on-therapy and post-therapy AE time period. The analysis was performed on Non-Insulin Population which comprised of participants in the ITT Population who were not on insulin at Baseline.|Up to 2.7 years|Non-Insulin Population|||Events per 100 person years||95% Confidence Interval|Number
2575536|NCT02465515|Secondary|Time to First Occurrence of Adjudicated CV Death or Hospitalization for Heart Failure (HF)|Time to first occurrence of adjudicated CV death or hospitalization for HF was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.|Median of 1.65 person years for CV follow-up time period|ITT Population|||Events per 100 person years||95% Confidence Interval|Number
2575537|NCT02465515|Secondary|Time to First Occurrence of Adjudicated Stroke|Time to first occurrence of adjudicated stroke was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.|Median of 1.65 person years for CV follow-up time period|ITT Population|||Events per 100 person years||95% Confidence Interval|Number
2575538|NCT02465515|Secondary|Time to First Occurrence of Adjudicated MI|Time to first occurrence of adjudicated MI was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.|Median of 1.65 person years for CV follow-up time period|ITT Population|||Events per 100 person years||95% Confidence Interval|Number
2575539|NCT02465515|Secondary|Time to Adjudicated CV Death|Time to adjudicated CV death was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.|Median of 1.65 person years for the CV follow-up time period|ITT Population|||Events per 100 person years||95% Confidence Interval|Number
2575540|NCT02465515|Secondary|Time to First Occurrence of MACE or Urgent Revascularization for Unstable Angina|Time to first occurrence of CEC-adjudicated MACE (CV death, MI or stroke) or urgent revascularization for unstable angina was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.|Median of 1.65 person years for CV follow-up time period|ITT Population|||Events per 100 person years||95% Confidence Interval|Number
2575541|NCT02465515|Primary|Time to First Occurrence of Major Adverse Cardiovascular Events (MACE) During Cardiovascular (CV) Follow-up Time Period|Time to MACE defined as the time to first occurrence of Cardiovascular Endpoint Committee (CEC)-adjudicated MACE (CV death, myocardial infarction [MI] or stroke) was analyzed using a Cox Proportional Hazards regression model with treatment group as the only covariate. The incidence rate per 100 person years (100*number of participants with at least 1 event)/first event person-years) is presented along with 95% confidence interval. First event person-years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. The analysis was performed on the Intent to Treat (ITT) Population which comprised of all randomized participants excluding participants who did not provide consent.|Median of 1.65 person years for CV follow-up time period|ITT Population|||Events per 100 person years||95% Confidence Interval|Number
2575542|NCT02465489|Secondary|Number of Subjects With Adverse Events (AEs)|Number of subjects with AEs. AEs will include clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations, and laboratory tests.|Throughout the trial, from the time of the first dose until the last study visit (Day 36 or early termination)|The safety population included all subjects who received at least one of the investigational products under study|||participants|||Number
2575573|NCT02464917|Secondary|Neonatal Mortality||completed once infant is discharged home; anticipate 1-4 days||||Participants|||Count of Participants
2575545|NCT02465489|Primary|Cmax for Serum Deferiprone|Maximum measured serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|Samples were collected pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 8.0, 12.0, 16.0, and 24.0 hours post-dose.|The pharmacokinetic population included subjects who provided evaluable data for at least two study periods.|||μg/mL||Standard Deviation|Mean
2575546|NCT02465463|Secondary|Mean Cost of Treatment|Total cost was calculated as a summation of costs of medications, procedures, and fecal transplant used to treat C.difficile for each individual patient. A mean was calculated for both groups.|Post-Intervention (Month 6)|Participants that have completed the study.|||dollars||Standard Deviation|Mean
2575547|NCT02465463|Secondary|Mean Hospital Anxiety And Depression Scale (HADS) Score|The HADS is a fourteen item scale and each item on the questionnaire is scored from 0-3, from 0 = best and 3 = worst. A score can range between 0 and 21 for either anxiety or depression. Higher scores represent greater depressive/anxious symptoms.|Post-Intervention (Week 12)|No difference in anxiety and depression scores were seen between the two populations at baseline and at 12 weeks.|||units on a scale||Standard Deviation|Mean
2575548|NCT02465463|Secondary|Mean Short Form - 36 (SF-36) Score|SF-36: consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Post-Intervention (Week 12)|Participants that have completed the study.|||units on a scale||Standard Deviation|Mean
2575549|NCT02465463|Primary|Change in the Shannon Diversity Index|The Shannon Diversity Index is a quantitative measure that reflects how many different types (such as species) there are in a dataset (a community). 16s ribosomal gene sequencing and metabolomic profile of the gut microbiota were analyzed for both groups using the Shannon Diversity index (H). The greater the index, the more diverse a species.|Baseline, Post-Intervention (Week 12)|Participants that completed the study.|||H|||Number
2575550|NCT02465463|Primary|Number of Participants That Experience Serious Adverse Events|"A serious adverse event is any adverse experience that results in any of the following outcomes:~Death;~Life-threatening experience (adverse event is considered life-threatening if, in the view of either the investigator or sponsor, its occurrence places the patient or subject at immediate risk of death);~Requires inpatient hospitalization or prolongation of existing hospitalization;~Results in persistent or significant disability or incapacity;~Is a congenital anomaly or birth defect;~Is considered to be an important medical event (that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed in the definition above)."|Post-Intervention (Month 6)|Participants that completed the study.|||Participants|||Count of Participants
2575551|NCT02465463|Primary|Clinical Remission Rates|Clinical remission rate is defined as the number of participants with an absence of clinical symptoms and/or negative C.difficile stool PCR.|Post-Intervention (Week 12)|Participants that completed the study.|||Participants|||Count of Participants
2575552|NCT02465450|Secondary|JBT-101 (Lenabasum) Plasma Concentrations on Day 84|Plasma concentrations were reported for the lenabasum 20 mg QD, 20 mg BID, and placebo groups only, at Day 84.|Day 84||||ng/mL||Standard Deviation|Mean
2575553|NCT02465450|Primary|Number of Participants With Treatment Emergent Adverse Events.||84 days of treatment|These adverse events are based on subjects who entered Treatment Period 2 (n=81). The tabulation of adverse events includes all TEAEs.|||Participants|||Count of Participants
2575554|NCT02465437|Secondary|CRISS Individual Component (HAQ-DI Score) Change From Baseline.|Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline. Health Assessment Questionnaire - Disability Index includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are two or three questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). The eight scores of the eight sections are summed and divided by 8. If one section is not completed by a subject, the summed score is divided by 7. As such, maximum scores can vary with a min of 0. The result is the DI, the disability index or functional disability index. Higher scores indicate worse symptomology|Day 85 and 113||||units on a scale||Standard Deviation|Mean
2575555|NCT02465437|Secondary|CRISS Individual Component (Patient Global Assessment Score) Change From Baseline|"The LS mean change from baseline (CFB) at Visit 5 (Day 85) and 6 (Day 113) is provided for patient global assessment. Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline. The assessment at each specified visit will be performed with a segmented numerical version of the visual analogue scale in which the subject selects a whole number (0-10 integers) that best reflects the overall disease activity. The numerical rating score is anchored by two verbal descriptors, one of no disease activity (score of 0) and one of worse imaginable disease activity (score of 10), with numbers 1-9 spaced equidistance in between. The subject will select an integer to describe disease activity. The recall period is one week."|Day 85 and 113||||units on a scale||Standard Deviation|Mean
2575556|NCT02465437|Secondary|CRISS Individual Component (Physician Global Assessment Score) Change From Baseline|"The LS mean change from baseline (CFB) at Visit 5 (Day 85) and 6 (Day 113) is provided for physician global assessment. Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline. The Physician Global Assessment of disease activity will be performed using a segmented numerical version of the visual analogue scale in which the physician selects a whole number (0-10 integers) that best reflects the overall disease activity. The numerical rating score is anchored by 2 verbal descriptors, one of no disease activity (score of 0) and one of worse imaginable disease activity (score of 10), with numbers 1-9 spaced equidistance in between. The physician will select an integer to describe disease activity. The recall period is one week."|Day 85 and 113||||units on a scale||Standard Deviation|Mean
2575557|NCT02465437|Secondary|CRISS Individual Component (FVC Percent Predicted) Change From Baseline|The LS mean change from baseline (CFB) at Visit 5 (Day 85) and 6 (Day 113) is provided for FVC percent predicted. Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline.|Day 85 and 113||||percent predicted||Standard Deviation|Mean
2575574|NCT02464917|Secondary|Number of Newborns Admitted to the NICU (Neonatal Intensive Care Unit)|if newborns need higher intensity of care they are transferred to the Neonatal Intensive Care Unit.|completed once infant is discharged home; anticipate 1-4 days||||Participants|||Count of Participants
2575558|NCT02465437|Secondary|CRISS Individual Components (mRSS Total Score) Change From Baseline.|The LS mean change from baseline (CFB) at Visit 5 (Day 85) and 6 (Day 113) is provided for mRSS total score. Change from Change from Baseline was calculated as Visit 5 - Baseline and independently Visit 6 - Baseline. The mRSS consists of an evaluation of patient's skin thickness rated by clinical palpation using a 0-3 scale (0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch the skin into a fold for each of 17 surface anatomic areas of the body: face, anterior chest, abdomen, and, with right and left sides of the body separately evaluated, the fingers, forearms, upper arms, thighs, lower legs, dorsum of hands and feet. Individual values are summed and defined as the total skin score. Total score is 0 to 51 with higher scores indicating worse symptomology|Day 85 and 113||||units on a scale||Standard Error|Least Squares Mean
2575559|NCT02465437|Primary|Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (CRISS) at Day 85 and 113|CRISS components included the following domains: modified Rodnan skin score, forced vital capacity percent predicted, Physician Global Assessment, Patient Global Assessment, and Health Assessment Questionnaire Disability-Index. An algorithm determines the predicted probability of improvement from baseline by incorporating change in the mRSS, FVC percent predicted, Physician and Patient Global Assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A cut-off at 0.6 in the predicted probability of being improved has yielded the smallest misclassification error. Subjects are not considered improved if, between Visit 1 and 6, they develop new: 1) renal crisis; 2) decline in FVC% predicted by 15% (relative) from baseline and confirmed after 1 month; or 3) left ventricular failure (systolic ejection fraction < 45%) or pulmonary artery hypertension. Higher CRISS scores indicates improvement.|Day 85 and Day 113|Per the statistical analysis plan, the intent was to analyze all subjects receiving lenabasum and compare to those subjects receiving placebo for this endpoint. As such, individual lenabasum groups were not reported to follow the pre-specified statistical analysis plan. Only subjects with values at Visit 5 and 6 were included in this analysis.|||units on a scale||Full Range|Median
2575560|NCT02465437|Primary|Number of Participants With Treatment-emergent Adverse Events From Baseline at Day 113|The overall number of subjects with TEAE's per treatment group during active dosing (Days 1-84) plus the 28 day follow-up.|Part A: Day 113|Per the statistical analysis plan, the intent was to analyze all subjects receiving lenabasum and compare to those subjects receiving placebo for the primary endpoint. As such, individual lenabasum groups were not reported to follow the pre-specified statistical analysis plan.|||Participants|||Count of Participants
2575561|NCT02465372|Secondary|Acceptability of the Be a Champion! Program|Number of schools that indicated BAC was acceptable, based upon qualitative and quantitative feedback from principals, classroom teachers, and implementation teams.|Up to nine months.||||number of schools|Schools||Number
2575562|NCT02465372|Secondary|Feasibility of the Be a Champion! Program|Implementation monitoring to determine feasibility of the program as indicated by the percentage of planned tasks achieved with full fidelity and as determined by the number who, a) assembled an implementation team, b) completed all trainings, c) completed self-assessments, d) developed action plans, and e) executed at least one component of their action plans.|Up to nine months.||||schools|Schools||Number
2575563|NCT02465372|Primary|Change in Youth Physical Activity|Physical activity measured using an accelerometer at baseline and one-year follow-up (spring 2015 and spring 2016).|baseline and one-year follow-up||||minutes/day||Standard Deviation|Mean
2575564|NCT02465216|Secondary|Immunogenicity Responder Rate|Immunogenicity will be evaluated by measuring humoral and cellular responses to ID93 + GLA-SE at Day 70.|Day 70|Those participants without major protocol deviations and with samples available for analysis.|||Participants|||Count of Participants
2575565|NCT02465216|Primary|Number of Adverse Events|Safety outcomes will include solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; and serious adverse events after the first study injection until end of study follow-up.|224 days||||participants|||Number
2575566|NCT02465203|Secondary|Safety Parameters|Safety over time of previous alisporivir exposure|27 months|"There was no hypothesis testing as the study was prematurely terminated. AE and SAE data are provided in the Adverse Events section~There was no hypothesis testing in this study, as the study was prematurely terminated.~Study was powered for 105 participants, not 650~No data are available because data were not collected"||||||
2575567|NCT02465203|Secondary|Safety Parameters as Measured by Liver UltraSound and Lab Parameters|Development of hepatocellular carcinoma (HCC)|27 months|"There was no hypothesis testing in this study, as the study was prematurely terminated.~No data for any pre-specified Outcomes were analyzed.~There was no hypothesis testing in this study, as the study was prematurely terminated.~Study was powered for 105 participants, not 650~No data are available because data were not collected"||||||
2575568|NCT02465203|Secondary|Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters|Changes in liver function and disease over time|27 months|"There was no hypothesis testing in this study, as the study was prematurely terminated.~No data for any pre-specified Outcomes were analyzed.~There was no hypothesis testing in this study, as the study was prematurely terminated.~Study was powered for 105 participants, not 650~No data are available because data were not collected"||||||
2575569|NCT02465203|Secondary|Safety Parameters as Measured by HCV RNA Sequencing|Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro|27 months|"There was no hypothesis testing in this study, as the study was prematurely terminated.~Study was powered for efficacy of 650 participants, and only 105 were randomized~No data are available because data were not collected"||||||
2575570|NCT02465203|Primary|HCV RNA Sequencing|Persistence of resistance associated variants|27 months|"There was no hypothesis testing in this study, as the study was prematurely terminated.~4 patients with resistance associated variants have been identified at study start. Study was not powered for 105 participants"|||Number of particiants|||Number
2575571|NCT02465099|Primary|Estimated Intraoperative Blood Loss|Estimated blood loss during intraoperative Stage 1, defined as the period from first incision to the first bone violation/cut (e.g., first pedicle screw drill); and intraoperative Stage 2, defined as the period from first bone violation/cut to last suture.|Intraoperative|All subjects in which the procedure was started. There was one subject that was enrolled who was to receive treatment with ultrasonic dissection, but the procedure was not performed due to study closure. Therefore, N=19 subjects enrolled for the ultrasonic dissection group, but only 18 subjects received treatment.|||milliliters||Standard Deviation|Mean
2575577|NCT02464917|Secondary|Number of Newborns With Necrotizing Enterocolitis|condition that affects newborn bowels where the tissue undergoes necrosis|completed once infant is discharged home; anticipate 1-4 days||||Participants|||Count of Participants
2575578|NCT02464917|Secondary|Number of Newborns With Respiratory Distress Syndrome|syndrome typically affecting premature babies due to immature lung maturation or development|completed once infant is discharged home; anticipate 1-4 days||||Participants|||Count of Participants
2575579|NCT02464917|Secondary|Number of Newborns With an Apgar Score <7|quick test performed on all babies once born that access how babies transition after birth. The following signs are given values of 0, 1, or 2 and added to compute the Apgar score. The higher the points the better. maximum points is 10. minimum score is 0. Signs: Color (0=blue/pale, 1=acrocyanotic, 2=completely pink), Heart rate (0=absent, 1=<100 minute, 2=>100 minute), Reflex irritability(0=no response, 1=grimace, 2=cry), muscle tone (0=limp, 1=some flexion, 2=active motion), Respiration (0=absent, 1=weak cry; hypoventilation, 2=good, crying)|completed at 5 minutes of life, Apgar <7||||newborns|||Number
2575580|NCT02464917|Secondary|Umbilical Cord Bicarbonate (HCO3)|marker for metabolic acidosis|collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection||||mEq/L||Inter-Quartile Range|Median
2575581|NCT02464917|Secondary|Umbilical Cord Partial Pressure Carbon Dioxide (pCO2)|marker for metabolic acidosis|collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection||||mmHg||Inter-Quartile Range|Median
2575582|NCT02464917|Secondary|Umbilical Cord Base Excess|marker for metabolic acidosis|collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection||||mEq/L||Inter-Quartile Range|Median
2575583|NCT02464917|Primary|Umbilical Cord pH Levels|marker for metabolic acidosis|collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection||||pH||Inter-Quartile Range|Median
2575584|NCT02464540|Primary|Optical Properties of Laminate Veneers|"The color of laminate veneers will be performed with a spectrophotometer Vita Easyshade (Vita Zahnfabrik / Bad Saeckingen, Germany) based on Vita and 3D Master scales and on CIEL*a* b system. Data collected will be evaluated for translucency parameter (TP) and color difference (ΔE) according the thickness and color of the laminate veneers as well as color of dental substrate.~The acceptable threshold color difference for the CIEDE2000 method is 1.8 (Paravina et al, 2015). Greater color variation is desirable when a shade match between darker and lighter adjacent tooth substrates is required and values above the clinical thresholds for acceptability of color differences indicating lower masking ability of the material.~Level of Agreement Between the Color Observed by the Operator and the Color Named by the Spectrophotometer was included as a Primary or Secondary Outcome Measure, but data was not collected."|after luting the laminate veneers (at least 1 hours after cementation)|38 ceramic restorations were cemented (25 laminate veneers, 13 crowns; 37 in anterior teeth; 1 in posterior tooth).|||Delta E (color change)|ceramic restoration|Standard Deviation|Mean
2575585|NCT02464176|Secondary|Verbal Numeric Pain Score Comparisons|This secondary outcome includes pain scores utilizing the verbal numeric pain score scale (0 to 11). Higher values indicate worse outcomes (higher pain scores). Lower values are better.|24 hour||||scores on a scale||Inter-Quartile Range|Median
2575586|NCT02464176|Secondary|Total Opioid Consumption||30 hours||||oxycodone mg equivalents||Inter-Quartile Range|Median
2575587|NCT02464176|Secondary|Time to First Analgesic Request|Time (in minutes) will be recorded to first analgesic request following the block placement|30 hours||||minutes||Inter-Quartile Range|Median
2575588|NCT02464176|Primary|Duration of Sensory Blockade|The primary outcome will be duration of sensory blockade in the distribution of the lumbar plexus as determined by pin-prick sensation as tested every two hours with pin-prick sensation.|30 hours||||hours||Standard Deviation|Mean
2575589|NCT02464163|Secondary|Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine|Unsolicited adverse events (UAEs) Days 0-42.|42 Days|Safety Population|||Participants|||Count of Participants
2575590|NCT02464163|Secondary|Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination||13 months|Safety Population|||Participants|||Count of Participants
2575591|NCT02464163|Secondary|Reactogenicity Immediately After Each Injection, Extending to Day 7|Solicited events of local and systemic reactogenicity Days 0-7|7 Days|Reactogenicity Population|||Participants|||Count of Participants
2575592|NCT02464163|Primary|Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic.|"The primary endpoint will be seroprotection rate to the selected dose of adjuvanted H7 rHA, defined by a post-vaccination HAI titer ≥40 on Day 42. The definition of success will be a lower bound of the two-sided 95% CI ≥ 70% for adults <65 and ≥60% for adults ≥65 years of age."|42 Days|Modified Per Protocol Population|||Participants|||Count of Participants
2575593|NCT02464033|Secondary|Change in Immune System Markers From Baseline to Month 6 (Main Study Period) and Subsequent Visits During the Extension Study Period|Inflammatory markers, (e.g. TNF-alfa, IL-1 beta, IL-2, IL-17); Th2-deviation of cell-mediated immune response seen e.g. as increased ratio IL-5,10, 13 in comparison with IFN-gamma, TNF-alfa, IL-1 beta and IL-17; Regulatory T-cells. TNF=Tumor necrosis factor , IL=Interleukin, IFN=Interferon|Baseline and 6, 9, 15 and 30 months||2020-10-31|10/2020||||
2575594|NCT02464033|Secondary|C-peptide Fasting Concentration, Change From Baseline|C-peptide: Fasting, concentration, change from baseline to 30 months|Baseline and 30 months|ITT|||nmol/L||Standard Deviation|Mean
2575595|NCT02464033|Secondary|C-peptide Fasting Concentration, Change From Baseline|C-peptide: Fasting, concentration, change from baseline to 15 months|Baseline and 15 months|ITT|||nmol/L||Standard Deviation|Mean
2575596|NCT02464033|Secondary|C-peptide Fasting Concentration, Change From Baseline|C-peptide: Fasting concentration, change from baseline to 6 months|Baseline and 6 months|ITT|||nmol/L||Standard Deviation|Mean
2575597|NCT02464033|Secondary|C-peptide: Stimulated, 90 Minute Value, Change From Baseline|C-peptide: Stimulated, 90 minute value, change from baseline to 30 months|Baseline and 30 months|ITT, not performed for 1 patient hence no data available for 1 out of the 20 patients|||nmol/L||Standard Deviation|Mean
2575598|NCT02464033|Secondary|C-peptide: Stimulated, 90 Minute Value, Change From Baseline|C-peptide: Stimulated, 90 minute value, change from baseline to 15 months|Baseline and 15 months|ITT|||nmol/L||Standard Deviation|Mean
2615593|NCT01999192|Secondary|Proportions of Subjects With Low Disease Activity DAS28 ≤3.2||Week 12 & Week 24|||||||
2575599|NCT02464033|Secondary|C-peptide: Stimulated, 90 Minute Value, Change From Baseline|C-peptide: Stimulated, 90 minute value, change from baseline to 6 months|Baseline and 6 months|ITT, not performed for 2 patients hence no data available for 2 out of the 20 patients|||nmol/L||Standard Deviation|Mean
2575600|NCT02464033|Secondary|Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline|Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline|Baseline and 30 months|ITT|||IU||Standard Deviation|Mean
2575601|NCT02464033|Secondary|Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline|Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline|Baseline and 15 months|ITT|||IU||Standard Deviation|Mean
2575602|NCT02464033|Secondary|Exogenous Insulin Dose Per kg Body Weight and 24 Hours, Change From Baseline|Exogenous 24-hour insulin dose per kg body weight and 24 hours average, change from baseline|Baseline and 6 months|ITT|||IU||Standard Deviation|Mean
2575603|NCT02464033|Secondary|Hemoglobin A1c (HbA1c), Change From Baseline|Hemoglobin A1c (HbA1c), change from baseline to 30 months|Baseline and 30 months|ITT|||mmol/mol||Standard Deviation|Mean
2575604|NCT02464033|Secondary|Hemoglobin A1c (HbA1c), Change From Baseline|Hemoglobin A1c (HbA1c), change from baseline to 15 months|Baseline and 15 months|ITT|||mmol/mol||Standard Deviation|Mean
2575605|NCT02464033|Secondary|Hemoglobin A1c (HbA1c), Change From Baseline|Hemoglobin A1c (HbA1c), change from baseline to 6 months|Baseline and 6 months|ITT|||mmol/mol||Standard Deviation|Mean
2575606|NCT02464033|Secondary|Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L|Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 30 months|30 months|ITT|||Participants|||Count of Participants
2575607|NCT02464033|Secondary|Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L|Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 15 months|15 months|ITT|||Participants|||Count of Participants
2575608|NCT02464033|Secondary|Number of Patients With a Stimulated Maximum C-peptide Level Above 0.2 Nmol/L|Number of patients with a stimulated maximum C-peptide level above 0.2 nmol/L at 6 months|6 months|ITT|||Participants|||Count of Participants
2575609|NCT02464033|Secondary|C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline|Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 30 months|Baseline and 30 months at 0, 30, 60, 90 and 120 minutes post-dose|ITT, , MMTT not performed for 1 patient hence no data available for 1 out of the 20 patients|||nmol/L*min||Standard Deviation|Mean
2575610|NCT02464033|Secondary|C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline|Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 15 months|Baseline and 15 months at 0, 30, 60, 90 and 120 minutes post-dose|ITT|||nmol/L*min||Standard Deviation|Mean
2575611|NCT02464033|Secondary|C-peptide: Area Under the Curve (AUC 0-120 Min) During an MMTT, Change From Baseline|Weighted mean C-peptide: (AUC mean 0-120 min) during an MMTT, change from baseline to 6 months. MMTT=Mixed Meal Tolerance Test|Baseline and 6 months at 0, 30, 60, 90 and 120 minutes post-dose|ITT, MMTT not performed for 2 patients hence no data available for 2 out of the 20 patients|||nmol/L*min||Standard Deviation|Mean
2575612|NCT02464033|Primary|Number of Patients With an Infection Reported as Adverse Event Related to Study Treatment|Number of patients with an infection reported as Adverse Event related to study treatment (GAD-Alum and/or Etanercept),as an assessment of the tolerability|Month 1, 2, 3, 6, 9, 15 and 30|Safety|||Participants|||Count of Participants
2575613|NCT02464033|Primary|GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)|GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000|30 months|ITT|||U/mL||Standard Deviation|Mean
2575614|NCT02464033|Primary|GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)|GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000|15 months|ITT|||U/mL||Standard Deviation|Mean
2575615|NCT02464033|Primary|GAD65AB Titer Measured to Evaluate the Tolerability (Main Study Period)|GAD65AB titer (GADA) change from baseline. GAD65AB = Antibodies to GAD with molecular mass 65000|6 months|Intention To Treat (ITT)|||U/mL||Standard Deviation|Mean
2575616|NCT02464033|Primary|Number of Patients With Clinically Significant Laboratory Findings|Number of patients with clinically significant laboratory findings, laboratory measurements as an assessment of the tolerability|Month 1, 2, 3, 6, 9, 15 and 30|Safety|||Participants|||Count of Participants
2575617|NCT02464033|Primary|Number of Patients With Any Abnormal Findings From Physical Examinations After Baseline|Number of patients with any abnormal findings from physical examinations after baseline, including neurological assessments as an assessment of tolerability.|Month 1, 2, 3, 6, 9, 15 and 30|Safety|||Participants|||Count of Participants
2575618|NCT02464033|Primary|Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability|Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse|2 months|Safety|||Participants|||Count of Participants
2575619|NCT02464033|Primary|Number of Patients With Reactions of the Injection Site as an Assessment of the Tolerability|Number of patients with reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching, Other). Inspection of injection site 60 minutes after GAD-Alum injection by investigator or nurse|1 months|Safety|||Participants|||Count of Participants
2575620|NCT02463981|Primary|Pain Empathy Rating Scores|Subjects were required to rate their empathic feeling towards painful pictures on a Likert Scale ranging from 1-9 (1 = not at all and 9 = very painful). The effects of training on the empathy for pain were analyzed comparing the feedback group with the controls group. For each subject differences were calculated between pictures that were preceded by a training compared to a no-training block. Within the context of the present design we expected that training-induced increases in anterior insula activity should lead to higher pain empathy ratings in the training group as compared to the control group.|three days.|From the initial population of 37 participants 5 had to be excluded because of high head movement during fMRI acquisition. This is a standard procedure in fMRI studies given that the analysis is very susceptible to movement artifacts.|||units on a scale||Standard Error|Mean
2575683|NCT02462291|Secondary|Blood Cholesterol LDL (mg/dl)|A fasted venous blood sample was analyzed for low-density lipoprotein blood levels by standard techniques.|PRE and POST 6 months of treatment||||(mg/dl)||Standard Deviation|Mean
2575621|NCT02463981|Primary|Neural Activity of Anterior Insula During Neorofeedback Training|Neural activity was analyzed using standard fMRI analysis procedure that examine neural activity during training of anterior insula regulation. The measures include BOLD signal analysis (reflecting neural activity strengths) as well as functional connectivity analysis (that examine the interaction between different brain regions).|three days.|From the initial population of 37 participants 5 had to be excluded because of high head movement during fMRI acquisition. This is a standard procedure in fMRI studies given that the analysis is very susceptible to movement artifacts.|||percentage of BOLD signal change||Standard Error|Mean
2575622|NCT02463409|Secondary|Change in Apnea Hypopnea Index (AHI)|Change in AHI before and during treatment with theophylline|1 day||||units on a scale||Standard Error|Mean
2575623|NCT02463409|Secondary|Change in Resting Energy Expenditure (REE)|Change in REE before and during treatment with theophylline|1 day||||kcals per day||Standard Error|Mean
2575624|NCT02463409|Primary|Change in Urine cAMP|Change in urine cAMP (after parathyroid hormone stimulation) before and during treatment with theophylline|1 day|Patients treated with theophylline who maintained appropriate IV access. Only 3 patients had complete data available.|||fm/uL||Standard Deviation|Mean
2575625|NCT02463331|Secondary|Histopathological Response to Therapy|Histopathological response is achieved when there is minimal or no inflammation in hepatic tissue, as assessed by liver biopsy.|liver biopsy was was performed to evaluate histopathological response after 18 months of biochemical response|The histological response was only evaluated in the patients with biochemical remission, since in the patients without biochemical response it was already known that there would be activity in the liver tissue.|||Participants|||Count of Participants
2575626|NCT02463331|Primary|Biochemical Response to Therapy|The biochemical response is defined when there is normalization of hepatic enzymes, mainly AST and ALT.|six months||||Participants|||Count of Participants
2575627|NCT02463227|Secondary|Percentage of Participants Who Had a Confirmed HIV-1 RNA Greater Than or Equal to 200 Copies/mL at Week 4 of the ATI or Indication to Reinitiate ART Prior to Week 4 of the ATI|The secondary efficacy outcome was the percentage of participants who had a confirmed HIV-1 RNA greater than or equal to 200 copies/mL at week 4 of the ATI or indication to reinitiate ART prior to week 4 of the ATI.|Measured at weeks 1, 2, 3, and 4 of the ATI|Per protocol, the analysis population was limited to participants who received all scheduled VRC01 infusions and underwent an ATI according to protocol.|||percentage of participants||90% Confidence Interval|Number
2575628|NCT02463227|Secondary|Measured Values of VRC01 in Plasma in the First 8 Weeks of the Analytical Treatment Interruption (ATI)|Measured values of plasma VRC01, measured in micrograms per milliliter, through week 8 of the ATI. The median and range of all VRC01 measurements taken in the first 8 weeks of the ATI were reported.|Measured at weeks 1, 2, 3, 4, 5, 6, 7, and 8 of the ATI|Per protocol, the analysis population was limited to participants who received all scheduled VRC01 infusions and underwent an ATI according to protocol.|||micrograms/mL||Full Range|Median
2575629|NCT02463227|Secondary|Measured Value of Plasma VRC01 at the Time of Rebound|Measured value of plasma VRC01, measured in micrograms per milliliter, at the time of rebound. Rebound is defined as the point in time when plasma HIV-1 RNA surpassed 40 copies/mL.|Measured from entry through week 21 (Steps 1 and 2)|Per protocol, the analysis population was limited to participants who received all scheduled VRC01 infusions and underwent an ATI according to protocol.|||micrograms/mL||Full Range|Median
2575630|NCT02463227|Primary|Percentage of Participants Who Had a Confirmed HIV-1 RNA Greater Than or Equal to 200 Copies/mL at Week 8 of the Analytical Treatment Interruption (ATI) or Indication to Re-initiate ART Prior to Week 8 of the ATI|The primary efficacy outcome is the percentage of participants who had a confirmed HIV-1 RNA greater than or equal to 200 copies/mL at week 8 of the analytical treatment interruption (ATI) or indication to re-initiate ART prior to week 8 of the ATI.|Measured at Weeks 1, 2, 3, 4, 5, 6, 7, and 8 of the ATI|Per protocol, the analysis population was limited to participants who received all scheduled VRC01 infusions and underwent an ATI according to protocol.|||percentage of participants||90% Confidence Interval|Number
2575631|NCT02463227|Primary|Percentage of Participants Who Experienced a Grade 3 or Higher Systemic (i.e., Not a Local Reaction) Adverse Event (AE) That is Possibly, Probably, or Definitely Related to the Administration of the VRC01 Antibody|The primary safety outcome examined the occurrence of a Grade 3 or higher systemic (i.e., not a local reaction) adverse event (AE) possibly, probably, or definitely related to the administration of the VRC01 antibody. The DAIDS AE Grading Table (V2.0) was used.|Measured from entry through week 21 (Steps 1 and 2)|All participants exposed to study treatment (VRC01) were included.|||percentage of participants||95% Confidence Interval|Number
2575632|NCT02463097|Secondary|Number of Diabetic Ketoacidosis (DKA) Events|There is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis on number of Diabetic Ketoacidosis (DKA) Event.|3 months||||events|||Number
2575633|NCT02463097|Secondary|Number of Severe Hypoglycemia Events|There is no statistically powered secondary endpoint in this study. However, there will be a descriptive analysis of the number of Severe Hypoglycemia events.|3 months||||events|||Number
2575634|NCT02463097|Primary|Change in A1C|There is no statistically powered primary endpoint in this study. However, there will be a descriptive analysis of change in A1C.|Baseline and 3 months||||Percent||Standard Deviation|Mean
2575635|NCT02463071|Secondary|Efficacy of AZD0585 by Assessment of Percent Changes in Lp(a), RLP-C, PCSK9, and Hs-CRP|To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil).|From baseline to Week12||||% (percent change from baseline)||Standard Error|Least Squares Mean
2575636|NCT02463071|Secondary|Efficacy of AZD0585 by Assessment of Percent Changes in Small Dense LDL and LDL-C/Apo B Ratio|To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil).|From baseline to Week12||||% (percent change from baseline)||Standard Error|Least Squares Mean
2575637|NCT02463071|Secondary|Efficacy of AZD0585 by Assessment of Percent Changes in Apolipoproteins Profile|To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) . Apolipoproteins include Apolipoprotein A-I, Apolipoprotein A-II, Apolipoprotein B, Apolipoprotein B48, Apolipoprotein C-II, Apolipoprotein C-III and Apolipoprotein E.|From baseline to Week12||||% (percent change from baseline)||Standard Error|Least Squares Mean
2575684|NCT02462291|Secondary|Blood Cholesterol HDL (mg/dl)|A fasted venous blood sample was analyzed for high-density lipoprotein blood levels by standard techniques.|PRE and POST 6 months of treatment||||(mg/dl)||Standard Deviation|Mean
2575638|NCT02463071|Secondary|Efficacy of AZD0585 by Assessment of Percent Changes in Plasma Fatty Acids Profile.|To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) . The plasma fatty acids profile includes eicosapentaenoic acid, docosahexaenoic acid, arachidonic acid and eicosapentaenoic acid per arachidonic acid rate.|From baseline to Week12||||% (percent change from baseline)||Standard Error|Least Squares Mean
2575639|NCT02463071|Secondary|Efficacy of AZD0585 by Assessment of Percent Change in Serum Lipid Profile|To assess the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil). The serum lipid profile includes total cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol,Very low-density lipoprotein cholesterol and Non-high-density lipoprotein cholesterol.|From baseline to Week12||||% (percent change from baseline)||Standard Error|Least Squares Mean
2575640|NCT02463071|Primary|Safety of AZD0585 by Assessment of Adverse Events in Patients|To evaluate the long-term (up to 52 weeks) safety of AZD0585 in Japanese patients with hypertriglyceridemia.|From baseline to Week52|The Safety Analysis Set included all patients who took at least 1 dose of double-blind investigational product.|||Participants|||Number
2575641|NCT02463071|Primary|Efficacy of AZD0585 by Assessment of Percent Change in Serum Triglycerides|To demonstrate the efficacy of AZD0585 2 g and 4 g compared to placebo (corn oil) in Japanese patients with hypertriglyceridemia.|From baseline to Week12|The Full Analysis Set included all randomized patients who had both any baseline and any post-baseline efficacy measurements.|||% (percent change from baseline)||Standard Error|Least Squares Mean
2575642|NCT02462759|Secondary|Number of Participants With Plasma Antibodies to ISIS 396443||Part 2: Baseline to Day 596|The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure.|||Participants|||Count of Participants
2575643|NCT02462759|Secondary|CSF Concentration of ISIS 396443 in Part 1 and 2 of Study in Participants Who Received ISIS 396443 in Part 1 of the Study|CSF samples were analyzed for ISIS 396443 concentrations in participants. Study days were windowed for integrated analysis and labelled as follows: Days >1 to <= 22 as Day 15;Days >22 to <=47 as Day 29;Days >47 to <= 123 as Day 64;Days >123 to <=242 as Day 183;Days >242 to <=362 as Day 302;Days >362 to <=482 as Day 422;Days >482 to <= 600 as Day 540;Days >600 to <= 719 as Day 659;Days >719 to <= 838 as Day 778;Days >838 to <= 958 as Day 898;Days >958 to <= 1078 as Day 1018.|Pre-dose on Days 15, 29, 64, 183, 302, 422, 540, 659, 778, 898 and 1018|The PK population included all participants who were randomized and have at least 1 evaluable post dose or post sham-procedure PK sample. Number analyzed indicates participants who were evaluated for the specified time points.|||ng/mL||Standard Deviation|Mean
2575644|NCT02462759|Secondary|Cerebrospinal Fluid (CSF) Concentration of ISIS 396443 in Part 2 of Study in Participants Who Received Sham Procedure in Part 1 of the Study|CSF samples were analyzed for ISIS 396443 concentrations in participants. Study days were windowed for integrated analysis and labelled as follows: Days >1 to <= 22 as Day 15;Days >22 to <=47 as Day 29;Days >47 to <= 123 as Day 64;Days >123 to <=242 as Day 183;Days >242 to <=362 as Day 302;Days >362 to <=482 as Day 422;Days >482 to <= 600 as Day 540.|Pre-dose on Days 15, 29, 64, 183, 302, 422 and 540|The PK population included all participants who were randomized and have at least 1 evaluable post dose or post sham-procedure PK sample. Number analyzed indicates participants who were evaluated for the specified time points.|||ng/mL||Standard Error|Mean
2575645|NCT02462759|Secondary|Plasma Concentration of ISIS 396443 in Part 1 and 2 of Study in Participants Who Received ISIS 396443 in Part 1 of the Study|Study days were windowed for integrated analysis and labelled as follows: Days >47 to <= 123 as Day 64;Days >123 to <=242 as Day 183;Days >242 to <=362 as Day 302;Days >362 to <=482 as Day 422;Days >482 to <= 600 as Day 540;Days >600 to <= 719 as Day 659;Days >719 to <= 838 as Day 778;Days >838 to <= 958 as Day 898;Days >958 to <= 1078 as Day 1018;Days >1078 to <= 1198 as Day 1138.|Pre-dose on Days 64, 183, 302, 422, 540, 659, 778, 898, 1018 and 1138|The PK population included all participants who were randomized and have at least 1 evaluable post dose or post sham-procedure PK sample. Number analyzed indicates participants who were evaluated for the specified time points.|||ng/mL||Standard Deviation|Mean
2575646|NCT02462759|Secondary|Plasma Concentration of ISIS 396443 in Part 2 of Study in Participants Who Received Sham Procedure in Part 1 of the Study|Study days were windowed for integrated analysis and labelled as follows: Days >47 to <= 123 as Day 64;Days >123 to <=242 as Day 183;Days >482 to <= 600 as Day 540;Days >600 to <= 719 as Day 659.|Pre-dose on Days 64, 183, 540 and 659|The pharmacokinetic (PK) population included all participants who were randomized and have at least 1 evaluable post dose or post sham-procedure PK sample.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2575647|NCT02462759|Primary|Number of Participants With Presence of Urine Total Protein Post-baseline|Urine total protein was evaluated to assess safety.|Part 2: Up to 1080 days|The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure.|||Participants|||Count of Participants
2575648|NCT02462759|Primary|Number of Participants With Change From Baseline in International Normalized Ratio [INR])|"INR was evaluated to assess safety. Shift to low measured change in normal, high and unknown values of INR at baseline to low values postbaseline. Shift to high measured change in normal, high and unknown values of INR at baseline to high values postbaseline."|Part 2: Up to 1080 days|The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants whose baseline value was not low (or high) and who had at least one post-baseline measurement.|||Participants|||Count of Participants
2575649|NCT02462759|Primary|Number of Participants With Change From Baseline in Partial Thromboplastin Time [PTT]|"PTT was evaluated to assess safety. Shift to low measured change in normal, high and unknown values of PTT at baseline to low values postbaseline. Shift to high measured change in normal, high and unknown values of PTT at baseline to high values postbaseline."|Part 2: Up to 1080 days|The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants whose baseline value was not low (or high) and who had at least one post-baseline measurement.|||Participants|||Count of Participants
2575685|NCT02462291|Secondary|Blood Glucose (mg/dl)|A fasted venous blood sample will be analyzed for glucose blood levels by standard techniques.|PRE and POST 6 months of treatment||||(mg/dl)||Standard Deviation|Mean
2575686|NCT02462291|Secondary|Diastolic Blood Pressure (mmHg)|Diastolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.|PRE and POST 6 months of treatment||||(mmHg)||Standard Deviation|Mean
2575650|NCT02462759|Primary|Number of Participants With Change From Baseline in Activated Partial Thromboplastin Time [aPTT]|"Activated partial thromboplastin time was evaluated to assess safety. Shift to low measured change in normal, high and unknown values of aPTT at baseline to low values postbaseline. Shift to high measured change in normal, high and unknown values of aPTT at baseline to high values postbaseline."|Part 2: Up to 1080 days|The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants whose baseline value was not low (or high) and who had at least one post-baseline measurement.|||Participants|||Count of Participants
2575651|NCT02462759|Primary|Number of Participants With Change From Baseline in Neurological Examination Outcomes|Neurological examinations included assessment of mental status, level of consciousness, sensory function, motor function, cranial nerve function, reflexes, mood, speech/language and hearing.|Part 1: Baseline to Day 422; Part 2: Baseline to Day 596|The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure.|||Participants|||Count of Participants
2575652|NCT02462759|Primary|Change From Baseline in Body Length|Participants were analyzed for change in growth parameter of body length to evaluate clinical efficacy. WHO Child Growth Standards were used to determine the body length percentile. Study days were windowed for integrated analysis and labelled as follows: Days <=1 as Baseline; Days >1 to <= 22 as Day 15;Days >22 to <=47 as Day 29;Days >47 to <= 123 as Day 64;Days >123 to <=242 as Day 183;Days >242 to <=362 as Day 302;Days >362 to <=482 as Day 422;Days >482 to <= 600 as Day 540;Days >600 to <= 719 as Day 659;Days >719 to <= 838 as Day 778;Days >838 to <= 958 as Day 898;Days >958 to <= 1078 as Day 1018;Days >1078 to <= 1198 as Day 1138.|Part 2: Baseline, Day 15, 29, 64, 183, 302, 422, 540, 659, 778, 898, 1018 and 1138|Safety population: participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants who were evaluated for the specified time points. Due the early termination of Part 2, no participants in the ISIS 396443 Part 2(participants on sham in Part 1) were on study beyond Day 659.|||cm||Standard Deviation|Mean
2575653|NCT02462759|Primary|Change From Baseline in Head to Chest Circumference (HCC) Ratio|Participants were analyzed for change in growth parameter of HCC to evaluate clinical efficacy. WHO Child Growth Standards were used to determine the HCC circumference percentile. Study days were windowed for integrated analysis and labelled as follows: Days <=1 as Baseline; Days >1 to <= 22 as Day 15;Days >22 to <=47 as Day 29;Days >47 to <= 123 as Day 64;Days >123 to <=242 as Day 183;Days >242 to <=362 as Day 302;Days >362 to <=482 as Day 422;Days >482 to <= 600 as Day 540;Days >600 to <= 719 as Day 659;Days >719 to <= 838 as Day 778;Days >838 to <= 958 as Day 898;Days >958 to <= 1078 as Day 1018;Days >1078 to <= 1198 as Day 1138.|Part 2: Baseline, Day 15, 29, 64, 183, 302, 422, 540, 659, 778, 898, 1018 and 1138|Safety population: participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants who were evaluated for the specified time points. Due the early termination of Part 2, no participants in the ISIS 396443 Part 2(participants on sham in Part 1) were on study beyond Day 659.|||ratio||Standard Deviation|Mean
2575654|NCT02462759|Primary|Change From Baseline in Weight|Participants were analyzed for change in growth parameter of weight to evaluate clinical efficacy. WHO Child Growth Standards were used to determine the weight percentile. Study days were windowed for integrated analysis and labelled as follows: Days <=1 as Baseline; Days >1 to <= 22 as Day 15;Days >22 to <=47 as Day 29;Days >47 to <= 123 as Day 64;Days >123 to <=242 as Day 183;Days >242 to <=362 as Day 302;Days >362 to <=482 as Day 422;Days >482 to <= 600 as Day 540;Days >600 to <= 719 as Day 659;Days >719 to <= 838 as Day 778;Days >838 to <= 958 as Day 898;Days >958 to <= 1078 as Day 1018;Days >1078 to <= 1198 as Day 1138.|Part 2: Baseline, Day 15, 29, 64, 183, 302, 422, 540, 659, 778, 898, 1018 and 1138|Safety population: participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants who were evaluated for the specified time points. Due the early termination of Part 2, no participants in the ISIS 396443 Part 2(participants on sham in Part 1) were on study beyond Day 659.|||kg||Standard Deviation|Mean
2575655|NCT02462759|Primary|Change From Baseline in Weight for Age|Participants were analyzed for change in growth parameter of weight for age to evaluate clinical efficacy. WHO Child Growth Standards were used to determine the weight for age percentile. Study days were windowed for integrated analysis and labelled as follows: Days <=1 as Baseline; Days >1 to <= 22 as Day 15;Days >22 to <=47 as Day 29;Days >47 to <= 123 as Day 64;Days >123 to <=242 as Day 183;Days >242 to <=362 as Day 302;Days >362 to <=482 as Day 422;Days >482 to <= 600 as Day 540;Days >600 to <= 719 as Day 659;Days >719 to <= 838 as Day 778;Days >838 to <= 958 as Day 898;Days >958 to <= 1078 as Day 1018;Days >1078 to <= 1198 as Day 1138.|Part 2: Baseline, Day 15, 29, 64, 183, 302, 422, 540, 659, 778, 898, 1018 and 1138|Safety population: participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants who were evaluated for the specified time points. Due the early termination of Part 2, no participants in the ISIS 396443 Part 2(participants on sham in Part 1) were on study beyond Day 659.|||kilogram (kg)||Standard Deviation|Mean
2575656|NCT02462759|Primary|Change From Baseline in Arm Circumference|Participants were analyzed for change in growth parameter of arm circumference to evaluate clinical efficacy. WHO Child Growth Standards were used to determine the arm circumference percentile. Study days were windowed for integrated analysis and labelled as follows: Days <=1 as Baseline; Days >1 to <= 22 as Day 15;Days >22 to <=47 as Day 29;Days >47 to <= 123 as Day 64;Days >123 to <=242 as Day 183;Days >242 to <=362 as Day 302;Days >362 to <=482 as Day 422;Days >482 to <= 600 as Day 540;Days >600 to <= 719 as Day 659;Days >719 to <= 838 as Day 778;Days >838 to <= 958 as Day 898;Days >958 to <= 1078 as Day 1018;Days >1078 to <= 1198 as Day 1138.|Part 2: Baseline, Day 15, 29, 64, 183, 302, 422, 540, 659, 778, 898, 1018 and 1138|Safety population: participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants who were evaluated for the specified time points. Due the early termination of Part 2, no participants in the ISIS 396443 Part 2(participants on sham in Part 1) were on study beyond Day 659.|||cm||Standard Deviation|Mean
2575687|NCT02462291|Secondary|Systolic Blood Pressure (mmHg)|Systolic blood pressure were measured with standard auscultatory and mercury sphygmomanometer technique.|PRE and POST 6 months of treatment||||(mmHg)||Standard Deviation|Mean
2575953|NCT02457793|Primary|Percentage of Participants With at Least One Adverse Event|An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.|Up to 15 months|All participants.|||percentage of participants|||Number
2575657|NCT02462759|Primary|Change From Baseline in Chest Circumference|Participants were analyzed for change in growth parameter of chest circumference to evaluate clinical efficacy. WHO Child Growth Standards were used to determine the chest circumference percentile. Study days were windowed for integrated analysis and labelled as follows: Days <=1 as Baseline; Days>1 to <= 22 as Day 15;Days >22 to <=47 as Day 29;Days >47 to <= 123 as Day 64;Days >123 to <=242 as Day 183;Days >242 to <=362 as Day 302;Days >362 to <=482 as Day 422;Days >482 to <= 600 as Day 540;Days >600 to <= 719 as Day 659;Days >719 to <= 838 as Day 778;Days >838 to <= 958 as Day 898;Days >958 to <= 1078 as Day 1018;Days >1078 to <= 1198 as Day 1138.|Part 2: Baseline, Day 15, 29, 64, 183, 302, 422, 540, 659, 778, 898, 1018 and 1138|Safety population: participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants who were evaluated for the specified time points. Due the early termination of Part 2, no participants in the ISIS 396443 Part 2(participants on sham in Part 1) were on study beyond Day 659.|||cm||Standard Deviation|Mean
2575658|NCT02462759|Primary|Change From Baseline in Head Circumference|Participants were analyzed for change in growth parameter of head circumference to evaluate clinical efficacy. WHO Child Growth Standards were used to determine the head circumference percentile. Study days were windowed for integrated analysis and labelled as follows: Days <=1 as Baseline; Days >1 to <= 22 as Day 15;Days >22 to <=47 as Day 29;Days >47 to <= 123 as Day 64;Days >123 to <=242 as Day 183;Days >242 to <=362 as Day 302;Days >362 to <=482 as Day 422;Days >482 to <= 600 as Day 540;Days >600 to <= 719 as Day 659;Days >719 to <= 838 as Day 778;Days >838 to <= 958 as Day 898;Days >958 to <= 1078 as Day 1018;Days >1078 to <= 1198 as Day 1138.|Part 2: Baseline, Day 15, 29, 64, 183, 302, 422, 540, 659, 778, 898, 1018 and 1138|Safety population: participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants who were evaluated for the specified time points. Due the early termination of Part 2, no participants in the ISIS 396443 Part 2(participants on sham in Part 1) were on study beyond Day 659.|||centimeter (cm)||Standard Deviation|Mean
2575659|NCT02462759|Primary|Number of Participants With Change From Baseline in Vital Signs|Clinically significant changes in vital signs were evaluated for assessing the safety of ISIS 396443. Vital signs that were assessed included resting systolic and diastolic blood pressure, pulse rate, respiratory rate, temperature, pulse oximetry, and transcutaneous carbon dioxide.|Part 1: Day 2, 29 and 422; Part 2: Day 1 to 596|The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure.|||Participants|||Count of Participants
2575660|NCT02462759|Primary|Number of Participants With Change From Baseline in Electrocardiograms (ECGs)|Clinically significant changes in ECG measurements were evaluated for assessing the safety of ISIS 396443.|Part 1: Day 2, 29 and 422; Part 2: Day 1 to 596|The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure.|||Participants|||Count of Participants
2575661|NCT02462759|Primary|Number of Participants With Change From Baseline in Clinical Laboratory Parameters|Clinically significant changes in laboratory parameters were evaluated for assessing the safety of ISIS 396443.|Part 1 and 2: From first dose/sham procedure to end of study (up to 1080 days)|The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure.|||Participants|||Count of Participants
2575662|NCT02462759|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A SAE is any untoward medical occurrence that at any dose results in death, life-threatening event, requires inpatient hospitalization, significant disability/incapacity or congenital anomaly.|Part 1 and 2: From first dose/sham procedure to end of study (up to 1080 days)|The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure.|||Participants|||Count of Participants
2575663|NCT02462720|Secondary|Patient Preference|Patient preference for RFA or Varithena® using e-diary|8 weeks||||Participants|||Count of Participants
2575664|NCT02462720|Secondary|Procedural Pain|degree of procedural pain perceived by the patient obtained immediately following the procedure using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine|immediately following procedure||||units on a scale||Standard Error|Mean
2575665|NCT02462720|Primary|Pain|14-day average post-treatment pain using a VAS pain score. VAS pain score is an integer-valued, interval scale variable with range from 0 to 100 representing the spectrum from no pain to pain as bad as one can imagine.|14 day average (0-100)||||units on a scale||Standard Error|Mean
2575666|NCT02462473|Secondary|Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12|The PSS is a brief scale designed to capture a psychiatric patient's satisfaction with a clinician. The scale covers 6 domains: Trust (3 items), Communication (3 items), Exploration of Ideas/Options (2 items), Body Language (2 items), Active Listening (4 items), and Miscellaneous Items (6 items). Out of the 20 items, the first 19 are scored on a 5-point Likert Scale (1=strongly disagree, 2=disagree, 3=satisfactory, 4=agree, 5=strongly agree). The last question (6f) is a free-response question asking for input on how the clinician might improve. Sum of scores of individual items give a total score (range 9-95). Higher scores indicate greater degree of satisfaction. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.|Week 0, Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.|||units on a scale|||Number
2575688|NCT02462291|Secondary|Body Composition (Kilograms of Fat Free Mass)|Body mass and skin-fold measurements were measured three times a day by the same experienced operator. The average value of the three measurements was calculated. Kilograms of fat free mass was estimated using a validated equation.|PRE and POST 6 months of treatment||||kg||Standard Deviation|Mean
2575954|NCT02457793|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|DLTs include symptoms considered by the investigator to be possibly related to study drug.|28 days (Cycle 1)|All participants.|||Participants|||Count of Participants
2575667|NCT02462473|Secondary|Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12|The BARS is a 4-item scale that includes 3 questions and an overall visual analog rating scale that assesses participant's knowledge about his/her medication. The key measure of adherence is the visual analog scale and assesses the percentage of doses taken by the participants in the past month (0 percent [%] - 100%). The 3 questions include: number of prescribed doses per day, number of days in the past month when the participant did not take the prescribed doses, and the number of days in the past month when the participant took less than the prescribed dose. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.|Week 0, Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.|||percent adherence|||Number
2575668|NCT02462473|Secondary|Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12|The CRS is an ordinal scale filled by the clinician. The scores range from 1 to 7 that were used to quantify the clinician's assessment of treatment adherence by the patient. Higher scores indicate greater adherence. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.|Week 0, Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.|||units on a scale|||Number
2575669|NCT02462473|Secondary|Number of Participants With Factors Considered in Clinical Decision as Assessed by Clinical Assessment of the Schizophrenia Patient (CASP)|The CASP and data on concomitant medications and psychosocial treatments were used to evaluate the impact of AMPL results on other aspects of clinical decision making.|Up to Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this endpoint.|||participants|||Number
2575670|NCT02462473|Secondary|Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12|AMPL of the individual participant during the active assessment phase was reported.|Week 12|AMPL analysis set included all enrolled participants who had AMPL data for at least 1 visit. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this endpoint.|||nanogram per milliliter|||Number
2575671|NCT02462473|Secondary|Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12|The DPSS is a clinician-rated scale used to rate 8 domains commonly seen in patients with psychotic disorders. Each domain was rated on a 5-point scale (0 to 4) with anchored description of endpoints. Total score was computed by summing the scores of individual items (range of 0-32). Higher scores represent more severe condition. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.|Week 0, Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.|||units on a scale|||Number
2575672|NCT02462473|Secondary|Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12|Clinical Global Impression-Severity (CGI-S) rating scale used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported.|Week 0, Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. One participant (Participant 4) was not analyzed at Week 12 due to discontinuation caused by death.|||units on a scale|||Number
2575673|NCT02462473|Primary|Number of Participants With Medication Treatment Modifications (MTM)|Information on MTMs derived from data collected in the clinical assessment of the schizophrenia patient (CASP) questionnaire. The CASP captured changes in medications, changes in psychosocial treatments, visit frequency, and the need for any acute interventions. The CASP comprised of 3 sections covering several parameters. The CASP captured changes in treatment options which was used to compute MTM, as well as factors in clinical decision making and the influence of antipsychotic medication plasma levels (AMPL), when they were available, on clinical decision making.|Up to Week 12|All enrolled participants who had a baseline CASP evaluation were included in the efficacy analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this endpoint.|||Participants|||Number
2575674|NCT02462291|Secondary|Number of Patients Treated With Ticlopidin||PRE and POST 6 months of treatment||||Participants|||Number
2575675|NCT02462291|Secondary|Number of Patients Treated With Memantine||PRE and POST 6 months of treatment||||Participants|||Number
2575676|NCT02462291|Secondary|Number of Patients Treated With Donepezil||PRE and POST 6 months of treatment||||Participants|||Number
2575677|NCT02462291|Secondary|Number of Patients Treated With Citalopram||PRE and POST 6 months of treatment||||Participants|||Number
2575678|NCT02462291|Secondary|Number of Patients Treated With Quetiapine||PRE and POST 6 months of treatment||||Participants|||Number
2575679|NCT02462291|Secondary|Number of Medications||PRE and POST 6 months of treatment||||Number of Medications||Standard Deviation|Mean
2575680|NCT02462291|Secondary|Salivary Cortisol (Nmol/l)|Levels of cortisol was measured via saliva samples using plain Sarstedt Salivette collection devices (Nümbrecht, Germany). Samples will be collected at 6.30 AM, 11.30 AM, and 6.30 PM. Immediately after collecting the saliva samples, were centrifuged for 2 min at 1,000 rpm. Purified saliva was stored in a freezer at -20 °C, and subsequently analyzed. Cortisol levels was determined by a time-resolved immunoassay with fluorometric detection.|PRE and POST 6 months of treatment||||(nmol/L)||Standard Deviation|Mean
2575681|NCT02462291|Secondary|Evaluation of Activity of Daily Life|Independence and level of activities of daily life (ADL) were evaluated with the Barthel index. Levels of ADL was measured by observing each resident's daily activities (eating, bathing, grooming, dressing, transfers from bed to chair, mobility on level planes, stairs, and getting on/off the toilet). The total score of the Barthel index is 0-100, and higher values represent a better outcome.|PRE and POST 6 months of treatment||||Scores on a scale||Standard Deviation|Mean
2575682|NCT02462291|Secondary|Daily Energy Expenditure (Kcal/Day)|Daily energy expenditure was measured with an Actiheart device (CamNtech, Cambridge, UK) allowing heart rate and acceleration data to be simultaneously recorded for 24 h/day for 7 consecutive days.|PRE and POST 6 months of treatment||||(Kcal/day)||Standard Deviation|Mean
2575689|NCT02462291|Primary|Evaluation of Cognitive Status (Score 0-30)|Through the use of Mini Mental State Examination (MMSE) the investigators estimated the severity and progression of cognitive impairment. MMSE is a questionnaire that examines cognitive functions including registration, attention, calculation, recall, language, ability to follow simple commands and orientation. The scale range of the MMSE tests is 0-30, and higher values represent a better outcome.|PRE and POST 6 months of treatment||||Scores on a scale||Standard Deviation|Mean
2575690|NCT02462291|Primary|Evaluations of Behavioral Disorders|Through the use of Neuropsychiatric Inventory (NPI), the investigators assessed the frequency and the severity of the behavioral disorders. The total scale range of the NPI is 0-144, and higher values represent worse outcome.|PRE and POST 6 months of treatment||||Scores on a scale||Standard Deviation|Mean
2575691|NCT02462148|Secondary|Time to First Opioid Analgesic Request|Time it took for the first opioid analgesic request was recorded.|0 to 36 hours||||minutes||Standard Deviation|Mean
2575692|NCT02462148|Secondary|Post Operative Opioid Use and Consumption|Amount of opioid use and consumption was recorded.|0-30 hours||||mg oxycodone equivalents||Standard Deviation|Mean
2575693|NCT02462148|Secondary|Neurologic Complications|Each patient will be followed for neurologic complications (paresthesias, etc) if they should occur.|throughout study completion, up to 48 hours||||neurological complications||Standard Deviation|Mean
2575694|NCT02462148|Secondary|Rate of Post Operative Nausea and Vomiting|Number of participants that experienced nausea and vomiting was recorded.|0 to 30 hours||||Participants|||Count of Participants
2575695|NCT02462148|Secondary|Verbal Pain Scores|Verbal Pain Scores will be compared between groups as obtained every six hours during hospitalization. Patients will be asked to provide verbal pain scores both at rest and with movement on a scale of 0-10 (0 being no pain and 10 being the worst pain). These scores will be taken at 0, 6, 12, 18, 24, and 30 hours.|0 to 30 hours||||units on a scale||Standard Deviation|Mean
2575696|NCT02462148|Primary|Duration of Sensory Nerve Block|The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. Testing will occur every two hours.|12 to 48 hours||||hours||Standard Deviation|Mean
2575697|NCT02462083|Primary|Percentage of Participants Who Experienced Grade 3 Local Skin Reactions|Local skin reactions (itching, dryness, burning/stinging) graded at a level of 3 (severe) at any point in the study following the first application of study drug were assessed. Severe Itching (as reported by the participant within the last 24 hours) referred to the intense itching that may interrupt daily activities and/or sleep. Severe dryness (as assessed by the investigator) referred to as marked roughness of the skin. Severe burning/stinging (as reported by the participant within the last 24 hours) referred to as hot burning sensation that causes definite discomfort and may interrupt daily activities and/or sleep. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to Week 52|Safety population included all participants who received at least one confirmed dose of study drug and had at least one post-baseline safety assessment.|||percentage of participants|||Number
2575698|NCT02462057|Primary|Enrollment in 10% Level of Benefit|Rates of enrolment in 10% cash-back level (the most basic level, requires online activation only) of the HealthyFood Benefit amongst members with diabetes|One month from initial emailed messages||||Participants|||Count of Participants
2575699|NCT02461992|Other Pre-specified|Number of Participants With Positive FVIII Inhibitor Activity at Day 4|As with all FVIII products, participants using Xyntha were monitored for the development of FVIII inhibitors. Values >= 0.6 Bethesda Unit (BU) per mL were considered positive results.|Day 4|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
2575700|NCT02461992|Other Pre-specified|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine pulse rate <50 beats per minute (bpm), >=30 bpm increase from baseline, or >25 bpm decrease from baseline; systolic blood pressure (SBP) <90 milliliters of mercury (mmHg), >=30 mmHg increase from baseline, or >=30 mmHg decrease from baseline; diastolic blood pressure (DBP) <50 mmHg, >=20 mmHg increase from baseline, or >=20 mmHg decrease from baseline.|Baseline up to Day 4|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
2575701|NCT02461992|Other Pre-specified|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, RBC morphology, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (urine drug screening, FVIII inhibitor assay, FVIII activity, prothrombin time [PT], activated partial thromboplastin time [APTT], anti-human immunodeficiency virus [HIV] 1, hepatitis C virus antibody [HCVAb], HAVAb, HBsAg, HBsAb, HBcAb). Only parameters which met abnormality criteria are reported.|Baseline up to Day 4|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
2575702|NCT02461992|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to Day 28|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
2576043|NCT02455076|Secondary|Average Number of Days of Hospital Stay|The average number of days in the hospital for subjects will be calculated.|Duration of hospital stay, an expected average of 10 days||||days||Inter-Quartile Range|Median
2615594|NCT01999192|Secondary|Proportions of Subjects With an Disease Activity Score DAS28 <2.6||Week 12 & Week 24|||||||
2575703|NCT02461992|Primary|Incremental Recovery (INCREC)|Incremental recovery is the increase in circulating FVIII activity for every IU of Xyntha administered per kilogram of body weight.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||IU/deciliter (dL) per IU/kg||Geometric Coefficient of Variation|Geometric Mean
2575704|NCT02461992|Primary|Mean Residence Time (MRT)|MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from zero time to infinity calculated as AUMCinf = AUMCt + ((t x Ct) / kel) + (Ct / kel^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||hour||Geometric Coefficient of Variation|Geometric Mean
2575705|NCT02461992|Primary|Terminal Elimination Half-Life (t1/2)|Terminal half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||hour||Standard Deviation|Mean
2575706|NCT02461992|Primary|Terminal Phase Rate Constant (Kel)|Terminal phase rate constant is the absolute value of the slope of a linear regression during the terminal phase of the natural--logarithm transformed concentration--time profile.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||1/hour||Geometric Coefficient of Variation|Geometric Mean
2575707|NCT02461992|Primary|Volume of Distribution at Steady-State (Vss)|Volume of distribution is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the volume of distribution at steady-state.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
2575708|NCT02461992|Primary|Clearance (CL)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||mL/hour/kg||Geometric Coefficient of Variation|Geometric Mean
2575709|NCT02461992|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||hour||Full Range|Median
2575710|NCT02461992|Primary|Area Under the Plasma FVIII Activity-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf)||Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||IU*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2575711|NCT02461992|Primary|Area Under the Plasma FVIII Activity-Time Profile From Time 0 to Time of the Last Quantifiable Concentration (AUClast)||Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The PK parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||IU*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2575712|NCT02461992|Primary|Maximum Plasma FVIII Activity (Cmax)||Pre-dose and 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32, 48, and 72 hours post-dose|The pharmacokinetic (PK) parameter analysis population is defined as all participants enrolled and treated who have at least 1 of the PK parameters of primary interest reported.|||IU/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
2575713|NCT02461966|Primary|Serum Aflatoxin Level in Liver Cancer Patients|Serum aflatoxin level in liver cancer patients in comparison to liver cirrhosis and controls.|6 months||||ng\ml||Standard Deviation|Mean
2575714|NCT02461758|Secondary|Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine|"Influenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine.~Higher antibody concentrations are associated with better protection from infection."|6 months post-immunization||||Antibody Titer||Inter-Quartile Range|Median
2575715|NCT02461758|Secondary|Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization|Seroprotection is defined by the FDA as post-immunization concentration of 1:160 that confers protection from infection to 95% of the population.|4 weeks||||participants|||Number
2575716|NCT02461758|Secondary|Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization|Seroprotection is defined as an antibody concentration of at least 1:40 at 4 weeks post-immunization which confers protection from infection in about 50% of individuals|4 weeks||||participants|||Number
2575717|NCT02461758|Secondary|Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion|Vaccine response rates for influenza vaccines in patients with inflammatory bowel disease will be accessed by number of patients who has shown significant seroconversion. Seroconversion is defined as a four fold increase in antibody concentration from preimmunization to 4 weeks post immunization.|4 weeks||||participants|||Number
2575718|NCT02461758|Primary|Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine|"Influenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine.~Higher antibody concentrations are associated with better protection from infection."|Pre-immunization and 2-4 weeks post immunization||||Antibody Titer||Inter-Quartile Range|Median
2576044|NCT02455076|Secondary|Total Daily Dose of Insulin Inpatient|The total daily dose of insulin needed for glycemic control from baseline through the patient's hospital stay will be recorded.|Duration of hospital stay, an expected average of 10 days||||units/day||Standard Deviation|Mean
2575719|NCT02461693|Primary|Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Mean Time to a Correct Hit|"Scanning Visual Vigilance Test. This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes. - from our publication"|45 to 105 minutes post pill consumption|One participant who received the caffeine pill had to use the restroom during the vigilance testing period and had to stop the test. Due to a technicality of the computer program, her data for the vigilance test was not available for analysis.|||seconds||Standard Error|Mean
2575720|NCT02461693|Primary|Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Number Correct, Number of False Alarm Hits|"Scanning Visual Vigilance Test. This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes. - from our publication"|45 to 105 minutes post pill consumption|One participant who received the caffeine pill had to use the restroom during the vigilance testing period and had to stop the test. Due to a technicality of the computer program, her data for the vigilance test was not available for analysis.|||counts||Standard Error|Mean
2575721|NCT02461693|Primary|Vigilance Score on Computer-based Test Using Random, Visual Stimulus: Proportion Correct (Out of 60)|"Scanning Visual Vigilance Test. This test assesses vigilance, ability to sustain attention during long, boring, continuous tasks that generate minimal cognitive load (Fine et al, 1994; Lieberman et al, 1998; 2002). The volunteer continuously scans a computer screen to detect an infrequent, difficult-to-detect stimulus that appears at random intervals and locations for 2 s. On average, a stimulus was presented once per minute. Upon detection of the stimulus, the volunteer pressed the space bar as rapidly as possible. Whether a stimulus was detected and time required for detection was recorded. Responses before or after stimulus occurrence were false alarms. The test lasted 60 minutes. - from our publication"|45 to 105 minutes post pill consumption|One participant who received the caffeine pill had to use the restroom during the vigilance testing period and had to stop the test. Due to a technicality of the computer program, her data for the vigilance test was not available for analysis.|||Proportion correct||Standard Error|Mean
2575722|NCT02461693|Primary|Mood State Score on POMS-2 Test|"Profile of Mood States (POMS-2)- Volunteers rated a series of 65 mood-related adjectives with regard to how they were feeling right now on a scale of 0 (not at all) to 4 (extremely). The adjectives factor into six mood sub-scales: Tension-Anxiety; Depression-Dejection; Anger-Hostility; Vigor-Activity; Fatigue-Inertia; Confusion-Bewilderment and a Total Mood Disturbance score which aggregates the six sub-scales into a single variable. - from our publication. The minimum and maximum possible raw scores were: 0 and 40 for Tension-Anxiety, 0 and 52 for Depression-Dejection, 0 and 44 for Anger-Hostility, 0 and 36 for Vigor-Aactivity, 0 and 24 for Fatigue-Inertia, 0 and 40 for Confusion-Bewilderment, -36 and 200 for Total Mood Disturbance, and 0 and 24 for Friendliness. For Friendliness and Vigor-Activity, the more positively a person feels, the higher the score. For all other sub-scales and Total Mood Disturbance, the more negatively a person feels, the higher the score."|30 minutes post pill consumption|Results are of raw data as presented in our publication|||units on a scale||Standard Error|Mean
2575723|NCT02461628|Secondary|Number of Subjects With Fever That Received Correct Treatment|The number of people with fever that report receiving correct treatment with regards to malaria (i.e., received an RDT test and took ACTs if the result was positive, or did not take ACTs if the test result was negative).|6 months, 12 months, 18 months|Subjects with fever who completed the survey at 6, 12, or 18 months.|||Participants|||Count of Participants
2575724|NCT02461628|Secondary|Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine)|Denominator is all those who took AL. Artemether lumefantrine is one type of ACT.|6 months, 12 months, 18 months|Subjects who received AL and completed the survey at 6, 12, or 18 months.|||Participants|||Count of Participants
2575725|NCT02461628|Secondary|Number of Participants Using an ACT Who Did Not Have a Test||6 months, 12 months, 18 months|Subjects who took AL and who completed the survey at 6, 12, or 18 months.|||Participants|||Count of Participants
2575726|NCT02461628|Secondary|Number of Participants Using ACT Who Had a Positive Test||6 months, 12 months, 18 months|Subjects who took AL and who completed the survey at 6, 12, or 18 months.|||Participants|||Count of Participants
2575727|NCT02461628|Primary|Number of Subjects With a Fever Who Receive a Malaria Test From Any Source||6 months, 12 months, 18 months|Subjects with fever who completed the survey at 6, 12, or 18 months.|||Participants|||Count of Participants
2575728|NCT02461589|Secondary|Change in Systolic and Diastolic Blood Pressure|"The data were analysed for the on-treatment until rescue medication observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy."|Week 0, Week 26|Full analysis set|||mmHg||Standard Deviation|Mean
2575729|NCT02461589|Secondary|Body Weight Change|"The data were analysed for the on-treatment until rescue medication observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy."|Week 0, Week 26|Full analysis set|||kg||Standard Deviation|Mean
2575730|NCT02461589|Secondary|Change in Fasting Plasma Glucose (FPG)|"Estimated mean change from baseline in FPG at week 26. The data were analysed for the on-treatment until rescue medication observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy."|Week 0, Week 26|"Full analyses set. For Semaglutide flexible arm, data was available only for 63 subjects."|||mmol/L||Standard Deviation|Mean
2575731|NCT02461589|Primary|Change in HbA1c (Glycosylated Haemoglobin)|"Estimated mean change from baseline in HbA1c at week 26. The data were analysed for the on-treatment until rescue medication observation period which includes observations recorded at or after date of first dose of trial product and not after the last dose of trial product plus the 7-day visit window or date of initiation of rescue therapy."|Week 0, week 26|Full analysis set|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2575732|NCT02461563|Secondary|C24hr of Metabolite M1 Following Multiple Dose Oral Administration of MK-1075|Blood was collected at 24 hours post-dose in order to determine the plasma C24hr of MK-1075 metabolite M1 for pooled GT1 and GT3 genotypes. A non-compartmental analysis on M1 plasma concentrations was performed where actual sampling times, converted to elapsed time relative to dosing times, by using the software Phoenix WinNonlin® Professional (Version 6.3).|Day 7 at 24 hours postdose|Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of major protocol deviations.|||μmol/L||Geometric Coefficient of Variation|Geometric Mean
2575733|NCT02461563|Secondary|Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-1075 Following Multiple Dose Oral Administration of MK-1075|Blood was collected at 24 hours post-dose in order to determine the plasma C24hr of MK- 1075 for pooled GT1 and GT3 genotypes. A non-compartmental analysis on MK-1075 plasma concentrations was performed where actual sampling times, converted to elapsed time relative to dosing times, by using the software Phoenix WinNonlin® Professional (Version 6.3).|Day 7 at 24 hours postdose|C24hr were not determined because concentrations of MK-1075 at 24 hour were not quantifiable.||||||
2575734|NCT02461563|Secondary|AUC 0-last of Metabolite M1 Following Multiple Dose Oral Administration of MK-1075|Blood was collected from pre-dose up to 120 hours post-dose in order to determine the plasma AUC 0-last of M1 for pooled GT1 and GT3 genotypes. A non-compartmental analysis on M1 plasma concentrations was performed where actual sampling times, converted to elapsed time relative to dosing times, by using the software Phoenix WinNonlin® Professional (Version 6.3). AUC was calculated using the linear-up/log-down trapezoidal method.|Day 7 at the following time points: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose|Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of major protocol deviations.|||hr*μmol/L||Geometric Coefficient of Variation|Geometric Mean
2575735|NCT02461563|Secondary|Area Under the Plasma Concentration Time Curve From Time 0 to Last (AUC 0-last) of MK-1075 Following Multiple Dose Oral Administration of MK-1075|Blood was collected from pre-dose up to 120 hours post-dose in order to determine the plasma AUC 0-last of MK-1075 for pooled GT1 and GT3 genotypes. A non-compartmental analysis on MK-1075 plasma concentrations was performed where actual sampling times, converted to elapsed time relative to dosing times, by using the software Phoenix WinNonlin® Professional (Version 6.3). AUC was calculated using the linear-up/log-down trapezoidal method.|Day 7 at the following time points: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours postdose|Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of major protocol deviations.|||hr*μmol/L||Geometric Coefficient of Variation|Geometric Mean
2575736|NCT02461563|Secondary|AUC 0-24hr of Metabolite M1 Following Multiple Dose Oral Administration of MK-1075|Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma AUC 0-24hr of the MK-1075 metabolite M1 for pooled GT1 and GT3 genotypes. A non-compartmental analysis on M1 plasma concentrations was performed where actual sampling times, converted to elapsed time relative to dosing times, by using the software Phoenix WinNonlin® Professional (Version 6.3). AUC was calculated using the linear-up/log-down trapezoidal method.|Day 7 at the following time points: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose|Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of major protocol deviations.|||hr*μmol/L||Geometric Coefficient of Variation|Geometric Mean
2575737|NCT02461563|Secondary|Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hrs (AUC 0-24hr) of MK-1075 Following Multiple Dose Oral Administration of MK-1075|Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma AUC 0-24hr of MK-1075 for pooled GT1 and GT3 genotypes. A non-compartmental analysis on MK-1075 plasma concentrations was performed where actual sampling times, converted to elapsed time relative to dosing times, by using the software Phoenix WinNonlin® Professional (Version 6.3). AUC was calculated using the linear-up/log-down trapezoidal method.|Day 7 at the following time points: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdose|AUC 0-24hr were not determined because concentrations of MK-1075 at 24 hour were not quantifiable||||||
2575738|NCT02461563|Primary|Change From Baseline in Maximum log10 HCV RNA Following Multiple Dose Oral Administration of MK-1075|Blood was collected on Days 1, 3, 4, 5, 6, 7, 21, 28 and 42, where baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing. Change from baseline in log10 HCV RNA levels, was determined, and the maximum reduction in HCV RNA was analyzed by an ANOVA model with a fixed effect for treatment. The primary hypothesis is, with a posterior probability larger than 70%, there is at least a 3 log10 reduction from baseline in HCV RNA.|Day 1 (pre-dose, 2, 4, 8, 12, and 24 hours postdose); Days 3, 4, 5, 6 (pre-dose); Day 7 (predose, 4, 12, 24, 48, 72, 96, 120, and 192 hours postdose); Days 21, 28 and 42|Participants who comply with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Compliance covers such considerations as exposure to treatment, availability of measurements and absence of major protocol deviations.|||log10 IU/mL||90% Confidence Interval|Least Squares Mean
2575770|NCT02461160|Secondary|Ratio of TAK-915 Metabolite Cmax to TAK-915 Cmax in SRD and MRD Cohorts||Day 1 predose and at multiple time points (up to 96 hours) post-dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||ratio||Standard Deviation|Mean
2575739|NCT02461563|Primary|Number of Participants Who Discontinued Treatment Due to an AE|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to Day 7|Participants who received at least one dose of the investigational drug.|||Participants|||Count of Participants
2575740|NCT02461563|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to Day 42|Participants who received at least one dose of the investigational drug.|||Participants|||Count of Participants
2575741|NCT02461550|Primary|The Frequency of Adverse Events|"Safety will be measured by using the NCI Common Terminology Criteria for Adverse Events (CTCAE v4.0). The goal of this study is to establish safety.~If there are 3 or more grade 3 or higher device related AEs, then we will stop the study."|2 years|Data were not collected||||||
2575742|NCT02461433|Secondary|General Health as Assessed by Short Form Survey (SF) 36|The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability|Up to 14 days postop||||units on a scale||Full Range|Mean
2575743|NCT02461433|Secondary|Pain as Assessed by Short Form Survey (SF) 36|The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability|Up to 14 days postop||||units on a scale||Full Range|Mean
2575744|NCT02461433|Secondary|Emotional Well Being as Assessed by Short Form Survey (SF) 36|The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability|Up to 14 days postop||||units on a scale||Full Range|Mean
2575745|NCT02461433|Secondary|Energy / Fatigue as Assessed by Short Form Survey (SF) 36|The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Energy and fatigue are aggregated in this section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability|Up to 14 days postop||||units on a scale||Full Range|Mean
2575746|NCT02461433|Secondary|Social Functioning as Assessed by Short Form Survey (SF) 36|The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability|Up to 14 days postop||||units on a scale||Full Range|Mean
2575747|NCT02461433|Secondary|Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36|The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability|Up to 14 days postop||||units on a scale||Full Range|Mean
2575748|NCT02461433|Secondary|Readmissions|Readmission events for the patients.|Up to 30 days postop||||readmission events|||Number
2575749|NCT02461433|Secondary|Physical Function as Assessed by Short Form Survey (SF) 36|The SF -36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability|Up to 14 days postop||||units on a scale||Full Range|Mean
2575750|NCT02461433|Secondary|Skin Bacterial Count as Assessed by Microbacterial Count|Skin bacterial count after removal of either Prevena or standard dressing. A micro-bacterial swap will be performed and sent to the microbiology lab for assessing bacterial count|Up to 7 days postop|The samples were not sent to the lab||||||
2575751|NCT02461433|Secondary|Other Wound Complications (Aggregate)|Dehiscence, seroma and hematoma. Reported as number of aggregate events.|Up to 14 days postop||||aggregate wound complication events|||Number
2575752|NCT02461433|Primary|Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines|The incidence of postoperative surgical site infection (according to National Healthcare Safety Network - Center for Disease Control guidelines) in open surgery|Up to 7 days postop||||Surgical Site infections|||Number
2575753|NCT02461355|Other Pre-specified|Change in Percent Script Words Omitted||Baseline to immediate, 2 weeks, and 4 weeks post-training|||||||
2575754|NCT02461355|Secondary|Change in Words Per Minute of Trained Scripts||Baseline to 2 weeks and 4 weeks post-training|Due to poor enrollment, data collection was not complete and therefore data was not analyzed. PI is now no longer at the institution.||||||
2575755|NCT02461355|Secondary|Change in Percent Correct of Trained Scripts||Baseline to 2 weeks and 4 weeks post-training|Due to poor enrollment, data collection was not complete and therefore data was not analyzed. PI is now no longer at the institution.||||||
2575756|NCT02461355|Primary|Change in Words Per Minute of Trained Scripts||From Baseline to up to 2 days post-training|Due to poor enrollment, data collection was not complete and therefore data was not analyzed. PI is now no longer at the institution.||||||
2575757|NCT02461355|Primary|Change in Percent Correct of Trained Scripts||From Baseline to up to 2 days post-training|Due to poor enrollment, data collection was not complete and therefore data was not analyzed. PI is now no longer at the institution.||||||
2575758|NCT02461290|Secondary|Percentage of Participants Alive at 1, 2, and 3 Years|Participants were followed for survival for up to 3 years. The overall survival rate at 1, 2, and 3 years was calculated as [number of participants alive divided by the number analyzed] multiplied by 100.|At 1, 2, and 3 years|ITT Population.|||percentage of participants|||Number
2577313|NCT02441218|Secondary|Death From Heart Failure|Component of cardiovascular death|From the date of randomisation to death, up to 42 months.||||participants|||Number
2575759|NCT02461290|Secondary|Percentage of Participants With CR According to International Working Group Response Criteria for NHL|Tumor response was evaluated according to criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. The percentage of participants achieving CR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)|Data Analysis Population.|||percentage of participants|||Number
2575760|NCT02461290|Secondary|Percentage of Participants With Complete Remission (CR) or Partial Remission (PR) According to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL)|Tumor response was evaluated according to criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as greater than or equal to (≥) 50 percent (%) decrease in sum of the products of greatest diameters (SPD) of the six largest dominant lymph nodes, no increase in size of other nodes, no increase in liver or spleen volume, a ≥50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. The percentage of participants achieving CR or PR was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)|Data Analysis Population: All enrolled participants who provided complete and evaluable outcome data.|||percentage of participants|||Number
2575761|NCT02461290|Primary|Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE|The safety and tolerability of rituximab was evaluated by collection of AEs, including clinically significant abnormalities and changes in laboratory data. An AE was defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in a congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately.|Up to 3 years (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)|ITT Population.|||participants|||Number
2575762|NCT02461160|Secondary|λz: Terminal Elimination Rate Constant for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort||Day 1 of Periods 1, 2 and 3 predose and at multiple time points (up to 96 hours) post-dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||1/hr||Standard Deviation|Mean
2575763|NCT02461160|Secondary|Terminal Elimination Half-life (t1/2) for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort||Day 1 of Periods 1, 2 and 3 predose and at multiple time points (up to 96 hours) post-dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||hr||Full Range|Median
2575764|NCT02461160|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort||Day 1 of Periods 1, 2 and 3 predose and at multiple time points (up to 96 hours) post-dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||hr||Full Range|Median
2575765|NCT02461160|Secondary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort||Day 1 of Periods 1, 2 and 3 predose and at multiple time points (up to 96 hours) post-dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||ng*hr/mL||Standard Deviation|Mean
2575766|NCT02461160|Secondary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort||Day 1 of Periods 1, 2 and 3 predose and at multiple time points (up to 96 hours) post-dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||ng*hr/mL||Standard Deviation|Mean
2575767|NCT02461160|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort||Day 1 of Periods 1, 2 and 3 predose and at multiple time points (up to 96 hours) post-dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||ng/mL||Standard Deviation|Mean
2575768|NCT02461160|Secondary|Ratio of TAK-915 Metabolite Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau Over a Dosing Interval [AUC(0-tau)] Where Tau is the Length of the Dosing Interval to TAK-915 AUC(0-tau) in MRD Cohorts||Day 14 predose and at multiple time points (up to 96 hours) post-dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||ratio||Standard Deviation|Mean
2575769|NCT02461160|Secondary|Ratio of TAK-915 Metabolite AUC(0-inf) to TAK-915 AUC(0-inf) in SRD Cohorts||Day 1 predose and at multiple time points (up to 96 hours) post-dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||ratio||Standard Deviation|Mean
2575996|NCT02456896|Secondary|Correlation Between Young Mania Rating Scale (YMRS) and Serum Brain Derived Neurotrophic Factor (BDNF)|"The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania.~Spearman's rank correlation coefficient (Spearman's ρ) was calculated for measuring correlation between YMRS score and serum BDNF."|At baseline|At baseline|||Spearman's ρ|||Number
2575771|NCT02461160|Secondary|AUC(0-tau): Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau Over a Dosing Interval Where Tau is the Length of the Dosing Interval for TAK-915 in DDI Cohort||Days 16 at multiple time points (up to 96 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||ng*hr/mL||Standard Deviation|Mean
2575772|NCT02461160|Secondary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-915 on Day 1 in DDI Cohort||Days 1 at multiple time points (up to 96 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||ng*hr/mL||Standard Deviation|Mean
2575773|NCT02461160|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-915 on Day 1 in DDI Cohort||Days 1 at multiple time points (up to 96 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||ng/mL||Standard Deviation|Mean
2575774|NCT02461160|Secondary|Renal Clearance (CLr) for TAK-915||SRD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||mL/hr||Standard Deviation|Mean
2575775|NCT02461160|Secondary|Fraction of Drug Excreted in Urine (Fe) for TAK-915||SRD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||fraction excreted||Standard Deviation|Mean
2575776|NCT02461160|Secondary|Total Amount of Drug Excreted in Urine (Ae) for TAK-915||SRD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||ng||Standard Deviation|Mean
2575777|NCT02461160|Secondary|Apparent Volume of Distribution (Vz/F) for TAK-915||SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||L||Standard Deviation|Mean
2575778|NCT02461160|Secondary|CL/F: Apparent Clearance for TAK-915||SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. Number of participants analysed is the participants who were evaluable in each cohort.|||L/hr||Standard Deviation|Mean
2575779|NCT02461160|Secondary|Terminal Elimination Half-life (t1/2) for TAK-915||SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||hr||Full Range|Median
2575780|NCT02461160|Primary|AUC(0-24) for Midazolam After Single Dose (Day 1)/AUC(0-24) for Midazolam After 7 Daily Doses of TAK-915 (Day 16) in DDI Cohort||Days 1 and 16 pre-dose and at multiple timepoints (up to 24 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||Ratio||Standard Deviation|Mean
2575781|NCT02461160|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for Midazolam Alone (Day 1) and in the Presence of TAK-915 (Day 16) in DDI Cohort||Days 1 and 16 pre-dose and at multiple timepoints (up to 24 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||ng*hr/mL||Standard Deviation|Mean
2575782|NCT02461160|Primary|Cmax: Maximum Observed Plasma Concentration for Midazolam Alone (Day 1) and in the Presence of TAK-915 (Day 16) in DDI Cohort||Days 1 and 16 pre-dose and at multiple timepoints (up to 24 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||ng/mL||Standard Deviation|Mean
2575783|NCT02461160|Primary|Time Dependency Assessment From AUC(0-24) After Last Dose for TAK-915 on Day 14 in MRD Cohorts Compared to AUC(0-inf) After a Single Dose on Day 1||Days 1 and 14 pre-dose and at multiple time points (up to 96 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||ratio||Standard Deviation|Mean
2575784|NCT02461160|Primary|Rac(Cmax): Accumulation Ratios Between Day 14 Cmax and Day 1 Cmax for TAK-915||Days 1 and 14 pre-dose and at multiple time points (up to 96 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||Ratio||Standard Deviation|Mean
2615595|NCT01999192|Secondary|Proportions of Subjects With an ACR 50 & 70 Response.||Week 12 & Week 24|||||||
2575785|NCT02461160|Primary|Rac(AUC): Accumulation Ratios Between Day 14 AUC(0-24) and Day 1 AUC(0-24) for TAK-915||Days 1 and 14 pre-dose and at multiple time points (up to 96 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||Ratio||Standard Deviation|Mean
2575786|NCT02461160|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-915||Day 1 pre-dose and at multiple time points (up to 96 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||ng*hr/mL||Standard Deviation|Mean
2575787|NCT02461160|Primary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-915||SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1, 8 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||ng*hr/mL||Standard Deviation|Mean
2575788|NCT02461160|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-915||SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1, 8 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||ng*hr/mL||Standard Deviation|Mean
2575789|NCT02461160|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-915||SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1, 8 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||ng/mL||Standard Deviation|Mean
2575790|NCT02461160|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-915||SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1, 8 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose|Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam.|||hr||Full Range|Median
2575791|NCT02461160|Primary|Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters|The percentage of participants who meet markedly abnormal criteria for ECG parameters as specified by the protocol and statistical analysis plan during the treatment period. ECG parameters were considered abnormal if they were beyond the values defined in categories.|Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28)|Safety set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
2575792|NCT02461160|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants who meet markedly abnormal criteria for vital signs after dosing, including oral body temperature (temp.), respiration rate, pulse rate (PR) Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) for assessment in positions of supine or standing. Vital signs were considered abnormal if they were beyond the values defined in categories.|Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28)|Safety set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
2575793|NCT02461160|Primary|Percentage of Participants With Markedly Abnormal Safety Laboratory Tests|The percentage of participants with any markedly abnormal standard safety laboratory values, including haematology, serum chemistries, or urinalysis, during the treatment period.|Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28)|Safety set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
2575794|NCT02461160|Primary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28)|Safety set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
2575795|NCT02461134|Other Pre-specified|Assessment of a Partial or Complete Overall Response at Week 24|The exploratory efficacy endpoint is based on the 2014 NIH Consensus Development Project response criteria. A complete overall response is defined as a resolution of all reversible manifestations due to chronic GVHD in each organ as defined per NIH Consensus Development Project response criteria. A partial overall response is defined as improvement in a measure for at least one organ without progression in measures for any other organ.|At Week 24|Due to the premature termination of the study and consequent lack of meaningful data, no analyses were performed. The statistical analysis plan issued is obsolete, it was not finalized and was therefore not executed.||||||
2575827|NCT02460458|Primary|General Laboratory Tests for VWD3 Diagnosis (Composite)|Hemoglobin: (mmol/L), HT(%), MVC (fl); Leucocytes: (E9/L); Neutrophil (%); Basophil (%); Eosinophil (%); Lymphocyte (%); Platelet count: (E9/L), MPV (fl); Prothrombin Time (sec); PTT (sec); PTT mix 50:50 (sec); Ferritin (ug/l); Bleeding Time (min:sec); Closure Time (Sec); Collagen/ADP (sec); Collagen/Epinephrine (sec); FVIII:C (IU/mL); VWF:RCo (IU/mL); VWF:Ag (IU/mL).|36 months (retrospective + confirmatory phase)|||||||
2615596|NCT01999192|Secondary|Proportions of Subjects With an ACR 20 Response.||Week 24|||||||
2575796|NCT02461134|Secondary|Incident Rate of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|This outcome measure reports the occurrence of adverse events (AEs), and serious adverse events (SAEs) during the treatment period and the follow-up period, and AEs leading to premature discontinuation of study drug. A treatment-emergent AE is any AE temporally associated with the use of study treatment whether or not considered by the investigator as related to study treatment.|From the first study drug intake up to 30 days after last study drug intake (Week 24)|The premature termination of the study led to a consequent lack of meaningful data. As the statistical analysis plan issued was not finalized and was not executed, no statistical analyses were performed. As there was only 1 patient enrolled in the study, the safety events reported occur with 100% frequency.|||Participants|||Count of Participants
2575797|NCT02461134|Primary|Change in Peripheral Absolute Lymphocyte Count From Baseline to Week 4, 8 and 12|The primary pharmacodynamic endpoint assesses intra-subject dose response during the first 12 weeks of treatment.|From baseline to Week 12|Due to the premature termination of the study and consequent lack of meaningful data, no analyses were performed. The statistical analysis plan issued is obsolete, it was not finalized and was therefore not executed.||||||
2575798|NCT02460991|Other Pre-specified|FACT-Hep Quality of Life|FACT-Hep quality of life instrument validated in patients with Hepatic cancer.|2 years|||||||
2575799|NCT02460991|Other Pre-specified|Proportion Achieved Tumor Response|The proportion of patients in each group that achieve complete response (CR), partial response (PR), and stable disease (SD) will be presented and compared across treatment groups.|2 years|||||||
2575800|NCT02460991|Secondary|Frequency of Treatment Emergent Adverse Events|The frequency of treatment emergent adverse events at 30 day, 3, 6, 9, 12, 18, and 24-months following the initial treatment. The proportions of patients in each arm experiencing treatment emergent adverse events will be presented descriptively with the number experiencing the event, the number evaluated, the percentage, and the exact two-sided 95% confidence interval.|2 years|Study was terminated early. Adverse events were captured through the end of the study.|||participants|||Number
2575801|NCT02460991|Secondary|Proportion Progression Free|Proportion Progression-Free (PPF) at one year|1 year|The planned analyses were not performed due to early termination.|||Participants|||Count of Participants
2575802|NCT02460991|Secondary|Time to Extrahepatic Spread|Time to Extrahepatic Spread for each subject|2 years|The planned analyses were not performed due to early termination.|||Participants|||Count of Participants
2575803|NCT02460991|Secondary|Time to Progression|Time to progression (TTP) determined by radiological assessment using mRECIST criteria|2 years|The planned analyses were not performed due to early termination.|||Participants|||Count of Participants
2575804|NCT02460991|Primary|Overall Survival|Overall survival in HCC subjects with minimum follow-up of subjects to at least one year|1 year|The planned analyses were not performed due to early termination.||||||
2575805|NCT02460978|Secondary|Percentage of Subjects With HbA1c Reduction From Baseline to Week 24 Last Observation Carried Forward (LOCF) >= 0.5% and Without Severe Hypoglycemia Events at Week 24|To compare dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin for the proportion of subjects achieving an HbA1c reduction from baseline to Week 24 visit >=0.5% without severe hypoglycemia events|Baseline and 24 weeks|Number of subjects in the full analysis set with non-missing baseline and Week 24 (LOCF) values.|||Participants|||Count of Participants
2575806|NCT02460978|Secondary|Change From Baseline in the Percent of 24-hour Glucose Readings Obtained From CGM That Falls Within the Target Range of > 70 mg/dL and <= 180 mg/dL (%) at Week 24|To compare the change from baseline in the percent of 24-hour glucose readings obtained from CGM that falls within the target range of >70 mg/dL and <=180 mg/dL with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment|Baseline and 24 weeks|Number of subjects in the full analysis set with non-missing baseline and at least one post-baseline value|||% of readings||95% Confidence Interval|Least Squares Mean
2575807|NCT02460978|Secondary|Adjusted Mean Change From Baseline in 24-hour CGM Mean Amplitude of Glycemic Excursion (MAGE) Value at Week 24|To compare the change from baseline in mean amplitude of glucose excursions (MAGE) of 24-hour glucose readings obtained from CGM with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment|Baseline and 24 weeks|Number of subjects in the full analysis set with non-missing baseline and at least one post-baseline value|||mg/dL||95% Confidence Interval|Least Squares Mean
2575808|NCT02460978|Secondary|Adjusted Mean Change From Baseline in 24-hour Continuous Glucose Monitoring (CGM) Mean Value at Week 24|To compare the change from baseline in mean value of 24-hour glucose readings obtained from CGM with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment|Baseline and 24 weeks|The number of subjects in the full analysis set with non-missing baseline and at least one post-baseline value|||mg/dL||95% Confidence Interval|Least Squares Mean
2575809|NCT02460978|Secondary|Adjusted Mean Percentage Change From Baseline in Body Weight at Week 24|To compare the percentage change from baseline in body weight with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment|Baseline and 24 weeks|Number of subjects in full analysis set with non-missing baseline and at least one post-baseline value|||Percentage change||95% Confidence Interval|Least Squares Mean
2575810|NCT02460978|Secondary|Adjusted Mean Percentage Change From Baseline in Total Daily Insulin Dose at Week 24|To compare the percent change from baseline in total daily insulin dose with dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment|Baseline and 24 weeks|Number of subjects in full analysis set with non-missing baseline and at least one post-baseline value|||Percentage change||95% Confidence Interval|Least Squares Mean
2575811|NCT02460978|Primary|Adjusted Mean Change From Baseline in HbA1c at Week 24|To compare the change from baseline in HbA1c between dapagliflozin 5 mg or 10 mg plus adjustable insulin versus placebo plus adjustable insulin after 24 weeks of double-blinded treatment|Baseline and 24 weeks|The analysis population for this endpoint is the number of subjects in the full analysis set with non-missing baseline and at least one post-baseline value. The full analysis set consists of all randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period.|||HbA1c (%)||95% Confidence Interval|Least Squares Mean
2575812|NCT02460822|Secondary|Improved Quality of Life|"The investigators will use the FACT-G survey to assess four dimensions of patients health (physical, functional, social and emotional). For each of the dimensions, patients are given a series of statements about specific elements of well being and asked to rank them on the following scale: Not at all, a little bit, Somewhat, Quite a bit, or Very much. These items are given numeric values of 0-4, with negatively worded statements reverse coded. Within each of the four dimensions of health, average scores are calculated, and then an overall sum is derived. Total well-being ranges from 0 (Complete lack of well being) to 16 (Completely well).~The number presented is the count of participants for whom the overall FACT-G score increased between baseline and 8-week followup. Because this is a small pilot study, we measure ANY increase with no threshold specified."|Baseline and 8 weeks post enrollment||||Participants|||Count of Participants
2575813|NCT02460822|Secondary|Symptom Burden Reduction|"The investigators will use the MD Anderson Symptom Inventory (MDASI) to describe patient experiences in 8 core symptom areas (pain, fatigue, nausea, disturbed sleep, distress, lack of appetite, weakness, and diarrhea). For each area, patients are asked to rank their symptoms on a scale from 0 (Not present) to 10 (As bad as you can imagine). The overall score is the mean across all 8 items.~The number reported here is the count of patients with a reduction in symptom burden between baseline and 8-week follow up. Because this is a small pilot study, we measure ANY reduction with no threshold specified."|8 weeks post enrollment||||Participants|||Count of Participants
2575814|NCT02460822|Secondary|Increased Mastery of Cancer and Chemotherapy Symptoms|"The investigators will use the Cancer Care Mastery Scale to assess patients' feelings of control over their cancer care. This scale is based on the Mastery Scale developed by Pearlin and Schooler, designed to capture the sense of control a patient feels over their cancer care. This is a 7-item scale where users are asked to respond to statements by choosing and answer from the following: Strongly disagree, Disagree, Neither agree or disagree, Agree, Strongly agree. Mastery scores were computed by taking the numeric mean of the items (1-5), with negatively worded items reversed.~The number presented here is the number of patients whose mastery score improved between baseline and the end of the 8-week program. Because this is a small pilot study, we measure ANY improvement with no threshold specified."|8 weeks post enrollment||||Participants|||Count of Participants
2575815|NCT02460822|Secondary|Physician Use of the Study Feedback Mechanism|The investigators will assess for how many of the enrolled patients the physicians use the feedback from the app to assist in clinical care of the patients. This includes following up about distressing symptoms and using information provided by the patient during regular clinical visits.|8 weeks post-enrollment||||Participants|||Count of Participants
2575816|NCT02460822|Primary|Patient Satisfaction and Usability of the MyChemoCare Application|"The investigators will use a 9-item survey developed by Dr. An to assess patients' experiences using the MyChemoCare app.~This result is the mean of the the survey items (with opposite items reversed). The scale was scored from 0 = Strongly disagree to 6 = Strongly agree."|8 weeks post enrollment||||units on a scale||Standard Error|Mean
2575817|NCT02460822|Primary|Patient Retention and Engagement With the MyChemoCare Application|Patient retention is defined as the number of patients who completed the 8-week study through the final evaluation. Engagement with the MyChemoCare application was measured as number of patients who checked in at least once per week of the study.|8 weeks post-enrollment||||Participants|||Count of Participants
2575818|NCT02460562|Secondary|Assessment of Enamel Caries|Caries record per surface using ICDAS coding system were determined at baseline and at 1.5 years of follow-up|Baseline and 1.5 years of follow up|The transition (∆Q) of surface number, n (%) of developed new caries from baseline to 1.5 years of follow up was determined as progression or arrested rate.|||Caries examined (number of surface)|Caries examined (number of surface)||Count of Units
2575819|NCT02460562|Primary|Saliva Fluoride Concentration (Part Per Million,Ppm)|Whole mixed saliva was collected by passive drooling into individual plastic vials to a volume of 2 ml while wearing the denture to determine the capacity for fluoride release and recharge from the denture. Saliva fluoride concentrations (ppm) were assessed at multiple time points (baseline, days 1, 14, 15, and 3 months and 1.5 years) to compare with baseline concentration under the conditions that the participants wear the resin denture at least 1 hour and refrain from tooth brushing at least 2 hours before saliva sampling. The salivary fluoride content (ppm) of each solution was determined using a fluoride ion electrode (item number 27502-19, Cole-Palmer, USA) connected to a 710 A plus fluoride ion meter (item number 067952, Thermo Orion, USA).|on days 1, 14, 15, and 3 months and 1.5 years of wearing the denture|A total of 150 Thai adults aged 35-60 years, were initially enrolled in this study. At a baseline visit, 31 males (20.7%) and 119 females (79.3%) with a mean age of 48.9 ± 10.6 years fulfilled the study inclusion criteria and participated in this study. Approximately eighty percent (119/150) of the study adults were followed over 1.5 years.|||part per million,ppm||Standard Deviation|Mean
2575820|NCT02460458|Primary|Type of VWF/FVIII-containing Concentrates in Use|Record of any VWF/FVIII-containing concentrates used and currently in use, including the current schedule type of treatment.|24 months (prospective phase)|||||||
2575821|NCT02460458|Primary|Adverse Events|Record of all adverse events occurred during the prospective phase of the study.|24 months (prospective phase)|||||||
2575822|NCT02460458|Primary|Record of Bleeding Episodes|Bleeding: severity, start date, stop date; Treatment: Product name, start date, stop date, Total IU, Total ED.|24 months (prospective phase)|||||||
2575823|NCT02460458|Primary|Allergic Reactions During Use of VWF-containing Concentrates|Record of any allergic and anaphilactic reactions occurred in the past due to the use of any VWF concentrate and the date of onset.|24 months (retrospective)||||participants|||Number
2575824|NCT02460458|Primary|Previous Use of Blood Products|Record of any product used in the previous 24 months (collected type of blood products/VWF concentrate, year of first exposure, units used).|24 months (retrospective)||||participants|||Number
2575825|NCT02460458|Primary|Molecular Diagnosis of VWF in DNA|Evaluation of the presence of VWF gene defects (confirmation or screening for the first time).|36 months (retrospective + confirmatory phase)|||||||
2575826|NCT02460458|Primary|Test for Anti-VWF Antibodies|Evaluation of the titre of Anti-VWF Antibodies through Bethesda test (BU).|36 months (retrospective + confirmatory phase)|||||||
2575997|NCT02456896|Primary|Change in Serum Brain Derived Neurotrophic Factor (BDNF)|Serum BDNF was estimated by ELISA using human BDNF ELISA kit from Boster Biological Technology Co. Ltd., Pleasanton, CA.|Baseline and 4 weeks||||pg/ml||Standard Deviation|Mean
2575828|NCT02460458|Primary|Bleeding Severity Score (BSS)|The range of measurement is from -1 to +4 for each symptom considered (12 symptoms, total range from -12 to 48). For each symptom: 0=no symptom, 1=referred by the patient, 2=brought to medical attention, 3=major intervention. For spontaneous hemorrhagic symptoms, scores equal or greater than two require that the patient has specifically addressed that hemorrhagic symptom with a physician, whatever has been the diagnosis and therapy subsequently proposed. Score 0 and 1 are attributed to symptoms referred by the patient, hence without any precise medical intervention. Score 0 is for negligible or absent symptoms; 1 otherwise. For surgical procedures, it is considered important to differentiate between patients that have never bled because they never underwent surgery and those that did not bled after a surgery. These latter receive a negative score, indicating that the probability of VWD diminishes if you don't bleed after surgery.|24 months (retrospective phase)||||Score on a scale||Full Range|Median
2575829|NCT02460380|Secondary|The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS|Ferriman-Gallwey score is a method used to assess and quantify hirsutism in women. A total score < 8 is considered normal whereas a score of 8 to 15 indicates mild hirsutism. A score >15 indicates moderate or severe hirsutism.|Baseline (pre-treatment) and 4 months later (two months after the completion of treatment)||||Scores on a scale||Standard Error|Mean
2575830|NCT02460380|Secondary|The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS|Lipid profile|Baseline (pre-treatment) and 8 weeks later (post-treatment)||||mg/dL||Standard Error|Mean
2575831|NCT02460380|Secondary|The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS|Free testosterone|Baseline (pre-treatment) and 8 weeks later (post-treatment)||||ng/dL||Standard Error|Mean
2575832|NCT02460380|Secondary|The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS|The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone insulin. The HOMA index was calculated as the product of fasting plasma blood glucose and insulin divided by 22.5.|Baseline (pre-treatment) and 8 weeks later (post-treatment)||||HOMA IR score||Standard Error|Mean
2575833|NCT02460380|Secondary|The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS|Blood pressure|Baseline (pre-treatment) and 4 months later (two months after the completion of treatment)||||mmHG||Standard Error|Mean
2575834|NCT02460380|Secondary|The Effects of Vitamin D3 on Clinical Disease Parameters in Women With PCOS|Interval between periods as a measure ovulatory dysfunction|Baseline (pre-treatment) and 4 months later (two months after the completion of treatment)||||Days||Standard Error|Mean
2575835|NCT02460380|Primary|Effect of Vitamin D on Angiogenic Factors|Serum VEGF level|Baseline (pre-treatment) and 8 weeks later (post-treatment)||||pg/mL||Standard Error|Mean
2575836|NCT02460380|Primary|Effect of Vitamin D on Angiogenic Factors|Serum TGF-β1/sENG ratio as a measure of TGF-β1 bioavailability|Baseline (pre-treatment) and 8 weeks later (post-treatment)||||ratio||Standard Error|Mean
2575837|NCT02460172|Secondary|Range of Motion|Knee Range of Motion for each knee will be measured in degrees|2 weeks and 6-8 weeks||||degrees|knees|Standard Deviation|Mean
2575838|NCT02460172|Secondary|Surgeon and Patient Scar Satisfaction|"Scar Satisfaction (both Zip and Staple sides) will be collected using a 5 point scale:~Very Satisfied Satisfied Neither Dissatisfied Very Dissatisfied"|6 to 8 wk follow up visit||||Participants|||Count of Participants
2575839|NCT02460172|Secondary|Patient Pain - Incisional and General|Pain levels will be collected using a 10 point VAS scale.|Throughout 8 week study period (Discharge, 2 wk follow up and 8 wk exit visit)|Patient incisional pain scores for Zip side and incisional pain scores for Staples side were collected (0=no pain, 10=worst pain imaginable)|||units on a scale||Standard Deviation|Mean
2575840|NCT02460172|Secondary|Surgeon Closure Method Satisfaction|"Closure method satisfaction will be collected by a 5 point satisfaction scale:~Very Satisfied~Satisfied~Neither~Dissatisfied~Very Dissatisfied A lower score means more satisfaction with the closure method."|6-8 weeks post op||||Participants|||Count of Participants
2575841|NCT02460172|Primary|Incision Appearance / Scar Cosmesis|"Patient Scar Rating (0=Best to 10=Worst). A lower score means better scar rating.~Surgeon Scar Rating (0=Best to 10=Worst). A lower score means better scar rating.~Independent Plastic Surgeon Scar Rating by 8 week post op photos. (0=Best to 10=Worst). A lower score means better scar rating."|6-8 weeks post surgery||||units on a scale||Standard Deviation|Mean
2575842|NCT02460159|Primary|Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN and Drug-Related Muscle Symptoms|Participants had CK levels assessed throughout the 52 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days that were reported as at least possibly-related to study drug were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 52 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
2575843|NCT02460159|Primary|Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN With Muscle Symptoms|Participants had CK levels assessed throughout the 52 week treatment period. Participants who had any CK level that was ≥10 x ULN and had associated muscle symptoms present within +/- 7 days were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 52 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
2575844|NCT02460159|Primary|Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN|Participants had creatine phosphokinase (CK) levels assessed throughout the 12 week treatment period. Participants who had any CK level that was ≥10 x ULN were recorded. The CK ULNs for males and females were 287 IU/L and 163 IU/L, respectively.|up to 52 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
2575845|NCT02460159|Primary|Percentage of Participants With Potential Hy's Law Condition|Percentage of Participants with Potential Hy's Law Condition (defined as serum ALT or serum AST elevations >3xULN, with serum alkaline phosphatase <2xULN and total bilirubin (TBL) ≥2xULN) was summarized. The ALT and AST ULNs were 40 U/L. The ULN for alkaline phosphatase was 359 IU/L and the ULN for total bilirubin was 1.2 mg/dL.|up to 52 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
2575846|NCT02460159|Primary|Percentage of Participants Who Experience Elevations in ALT or AST ≥10 Times ULN|Participants had ALT and AST levels assessed throughout the 52 week treatment period. Participants who had assessments of ALT and/or AST that were 10x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.|up to 52 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
2575847|NCT02460159|Primary|Percentage of Participants Who Experience Elevations in ALT or AST ≥5 Times ULN|Participants had ALT and AST levels assessed throughout the 52 week treatment period. Participants who had assessments of ALT or AST that were 5x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.|up to 52 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
2575848|NCT02460159|Primary|Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) ≥3 Times Upper Normal Limit (ULN)|Participants had ALT and AST levels assessed throughout the 52 week treatment period. Participants who had 2 consecutive assessments of ALT and/or AST that were 3 x ULN or greater were recorded. The ALT and AST ULNs were 40 U/L.|up to 52 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
2575849|NCT02460159|Primary|Percentage of Participants Who Experience 1 or More Hepatitis-related AEs|Hepatitis-related AEs included Cholestasis, Cytolytic Hepatitis, Hepatic Cyst, Hepatic Failure, Hepatic Lesion, Hepatic Necrosis, Hepatitis, Hepatitis Cholestatic, Hepatitis Fulminant, Hepatitis Infectious, Hepatocellular Injury, Hepatomegaly, Jaundice, Jaundice Cholestatic.|up to 54 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
2575850|NCT02460159|Primary|Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs|Allergic Reaction or Rash AEs included Allergy to Arthropod Sting, Anaphylactoid Reaction, Anaphylactic Reaction, Anaphylatic Shock, Anaphylactoid Shock, Angioedema, Conjunctivitis Allergic, Contrast Media Reaction, Dermatitis, Dermatitis Allergic, Dermatitis Atopic, Dermatitis Bullous, Dermatitis Contact, Dermatitis Psoriasiform, Drug Hypersensitivity, Eczema, Eosinophila, Erythema, Eye Allergy, Face Oedema, Hypersensitivity, Mechanical Urticaria, Palmar Erythema, Periorbital Oedema, Photodermatosis, Photosensitivity Allergic reaction, Photosensitivity Reaction, Pigmentation Disorder, Pruritus, Pruritus Generalised, Rash, Rash Erythematous, Rash Follicular, Rash Generalised, Rash Maculo-Papular, Rash Papulosquamous, Rash Pruritic, Rash Pustular, Rash Vesicular, Rhinitis, Rhinitis Allergic, Rosacea, Skin Exfoliation, Skin Disorder, Skin Hyperpigmentation, Skin Lesion, Skin Mass, Skin Ulcer, Subcutaneous Nodule, Swelling Face, Systemic Lupus Erythematosus Rash, Urticaria.|up to 54 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
2575851|NCT02460159|Primary|Percentage of Participants Who Experience 1 or More Gallbladder-related AEs|Gallbladder-related AEs included Bile Duct Obstruction, Bile Duct Stone, Bile Duct Stenosis, Biliary Colic, Cholangitis, Cholecystectomy, Cholecystitis, Cholelithiasis, Gallbladder Disorder, Gallbladder Perforation, Hepatic Pain, and Hydrocholecystis.|up to 54 weeks|All participants that received at least 1 dose of study drug and had available data for outcome.|||Percentage of Participants|||Number
2575852|NCT02460159|Primary|Percentage of Participants Who Experience 1 or More Gastrointestinal-related AEs|Gastrointestinal-related AEs included all preferred terms within system organ class of Gastrointestinal Disorders except Chapped Lips and Toothache.|up to 54 weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of participants|||Number
2575853|NCT02460159|Primary|Percentage of Participants Who Experience 1 or More Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized.|up to 54 Weeks|All participants that received at least 1 dose of study drug and had available data for endpoint.|||Percentage of Participants|||Number
2575854|NCT02459951|Other Pre-specified|Modified Ashworth Score (MAS)|A clinical ordinal measure of resistance to passive stretch of a limb on a scale of 0-4 with higher scores representing greater resistance|days between two baseline evaluations (mean 6; range 2-14) and days post-injection evaluation (mean 26; range 21-30)||||units on a scale||95% Confidence Interval|Median
2575855|NCT02459951|Secondary|Ratio of Successful Holds|ratio of successful holds post/pre1, post/pre2 or pre1/pre2|days between two baseline evaluations (mean 6; range 2-14) and days post-injection evaluation (mean 26; range 21-30)||||ratio||95% Confidence Interval|Mean
2575856|NCT02459951|Secondary|Fraction of Successful Holds for Each Evaluation Session|fraction of successful holds for each evaluation session (Pre1, Pre2, and Post)|days between two baseline evaluations (mean 6; range 2-14) and days post-injection evaluation (mean 26; range 21-30)||||fraction of successful holds||95% Confidence Interval|Mean
2575857|NCT02459951|Primary|Geometric Ratios of Log-transformed Transit Time|Time (log-transformed) required for contralateral hand to insert a plastic cylinder successfully into the hemiplegic clenched fist AND assessed at Pre-injection baseline 2 and a Post-injection session expressed as a geometric mean ratio of these sessions. (Success is defined by a hold of 5 secs or more). Geometric mean ratios are calculated for each of 5 cylinder sizes (A-E)|days post-injection evaluation (mean 26 days; range 21-30 days)||||dimensionless ratio||95% Confidence Interval|Geometric Mean
2575858|NCT02459899|Secondary|Change From Baseline to Week 12 in Fasting Plasma Glucose|Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline fasting plasma glucose-by-time interaction as a covariate.|Baseline to Week 12|Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||mg/dL||Standard Error|Least Squares Mean
2576014|NCT02455453|Primary|Change in Primary Tumor FFNP Uptake Before and After Estradiol Challenge as Measured by Percent Change in Standardized Uptake Value (SUV)||Completion of second FFNP-PET/CT scan (up to 4 weeks)|2 participants were not included in this outcome measure as the liver background was too high in both participants.|||percent change in SUV||Full Range|Median
2575859|NCT02459899|Secondary|Change From Baseline to Week 12 in 24-Hour Urinary Glucose Excretion|Urine was collected over 24 hours to measure Urinary Glucose Excretion at baseline, and at the end of the 12-week treatment. Post-Baseline LS mean was obtained from ANCOVA model with treatment, randomization strata of insulin delivery method (CSII, MDI) as fixed categorical effects, and Baseline urinary glucose excretion as a covariate.|Baseline, Week 12|Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||grams per day||Standard Error|Least Squares Mean
2575860|NCT02459899|Secondary|Percent Change From Baseline in Body Weight to Week 12|Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline weight-by-time interaction as a covariate.|Baseline to Week 12|Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||percent change||Standard Error|Least Squares Mean
2575861|NCT02459899|Secondary|Absolute Change From Baseline in Body Weight to Week 12|Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline weight-by-time interaction as a covariate.|Baseline to Week 12|Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||kilograms||Standard Error|Least Squares Mean
2575862|NCT02459899|Secondary|Change From Baseline to Week 12 in 2-Hour Postprandial Glucose (PPG) Following the Standardized Mixed Meal|A 2-hour PPG sample (plasma) was obtained 2-hours after a standardized Mixed Meal at Baseline (Day 1) and at the visit at Week 12. Post-Baseline LS mean was obtained from analysis of covariance (ANCOVA) model with treatment, randomization strata of insulin delivery method (CSII, MDI) as fixed categorical effects, and baseline postprandial glucose as a covariate.|Baseline, Week 12|Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2575863|NCT02459899|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 12|Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-baseline Least Square (LS) mean values were obtained from mixed-effects model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery method (continuous subcutaneous insulin infusion [CSII] or multiple daily injection [MDI]), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.|Baseline to Week 12|Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||percentage of A1C||Standard Error|Least Squares Mean
2575864|NCT02459665|Other Pre-specified|Feasibility/Acceptability of Vaginal Probiotic Use by Structured Face-to-face Interview|Full results have been submitted for publication. Adherence was measured at D7, M1, and M2 visits, and a summary measure over the entire period was calculated (available for women using oral metronidazole, Ecologic Femi+, or Gynophilus LP). After the 2-month intervention period, women using vaginal probiotics (Ecologic Femi+ or Gynophilus LP) were asked structured questions about their experiences with product use.|2 months (intervention period)|Adherence data are available for all randomized women except one woman in the Gynophilus LP group who withdrew immediately after enrollment. Acceptability data are available for all women randomized to the two vaginal probiotics groups except two women in the Gynophilus LP group (another woman withdrew prior to the Month 2 visit).|||Participants|||Count of Participants
2575865|NCT02459665|Secondary|Vaginal Microbiota Composition by Illumina HiSeq Sequencing: Lactobacillus Genus Concentration|The vaginal microbiota sequencing results are exploratory and full data can be found in a manuscript on the BioRxiv preprint server. The most important outcome is the concentration of Lactobacillus genus in vaginal samples taken at the end of the intervention period (M2 visit).|2 months (intervention period)|All randomized women except for one woman in Gynophilus LP who withdrew immediately after enrollment, using lactobacillus concentration in log10 copies per microliter at the M2 visit (at the time of intervention cessation).|||Lactobacillus log10 copies/microliter||95% Confidence Interval|Mean
2575866|NCT02459665|Primary|Vaginal Candidiasis Incidence by Wet Mount Microscopy|A wet mount is a smear of vaginal fluid on a microscopy slide, which is examined under a microscope. Yeasts are visible without staining. The definition of vaginal candidiasis was any yeast visible on the wet mount. Symptomatic vaginal candidiasis was considered a safety outcome because treatment of bacterial vaginosis often results in vaginal candidiasis. Intent-to-treat (ITT) analysis with person-years (PY) at risk as the denominator of all incidence rates.|6 months: 2 months intervention period plus 4 months after intervention cessation|All randomized women except one woman in the Gynophilus LP group who withdrew immediately after enrollment.|||Incidence: events per PY at risk||95% Confidence Interval|Number
2575867|NCT02459665|Primary|Trichomonas Vaginalis (TV) Incidence by Culture|"A swab was inoculated into an InPouch culture pouch, specifically designed for TV growth. The pouch was checked daily for five days to detect growth. The results was positive when growth detected and negative when no growth detected on the fifth day.~Intent-to-treat (ITT) analyses, using person-years (PY) at risk as the denominator for each incidence rate."|2 months (intervention period)|All randomized women except one woman in the Gynophilus LP group who withdrew immediately after enrollment.|||Incidence: events per PY at risk||95% Confidence Interval|Number
2575868|NCT02459665|Primary|Bacterial Vaginosis (BV) Incidence by Nugent Scoring (Nugent 7-10)|The Nugent score is a scale from 0-10 based on visualisation of three different bacterial morphotypes on a Gram stained slide, but in the incidence rates, the variable was used as a binary variable: BV present (Nugent score 7-10) or absent (Nugent score 0-6). Modified intent-to-treat (ITT) analyses (women with Nugent 7-10 at enrollment excluded), using person-years (PY) at risk as the denominator for each incidence rate.|2 months (intervention period)|Modified ITT population: All randomized women except women with Nugent 7-10 at enrollment.|||Incidence: events per PY at risk||95% Confidence Interval|Number
2577314|NCT02441218|Secondary|All-cause Mortality||From the date of randomisation to death, up to 42 months.||||participants|||Number
2575869|NCT02459665|Primary|Bacterial Vaginosis (BV) Incidence by Modified Amsel Criteria|"Modified Amsel criteria positive is at least 2 of 3 of the following positive: clue cells, vaginal pH, whiff test.~Modified intent-to-treat (ITT) analyses (women with Nugent 7-10 at enrollment excluded), using person-years (PY) at risk as denominator of each incidence rate."|2 months (intervention period)|Modified ITT population: all randomized women except women with Nugent 7-10 at enrollment.|||Incidence: events per PY at risk||95% Confidence Interval|Number
2575870|NCT02459418|Secondary|Baseline Corrected E2 Tmax|"Tmax was estimated for baseline corrected E2 in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.~Geometric mean was not calculated for Tmax and the non-transformed results are presented are for all subjects who received active study drug and had Tmax estimated in both periods."|From 0 hours (predose) to 192 hours postdose.|This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with Tmax estimated in both periods are included.|||hours||95% Confidence Interval|Median
2575871|NCT02459418|Secondary|Baseline Corrected E2 Cmax|"Cmax was estimated for baseline corrected E2 in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.~Geometric mean baseline corrected E2 exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PD time point after administration of AFOLIA or Gonal-f® RFF."|From 0 hours (predose) to 192 hours postdose.|This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with concentration data for determination of Cmax are included.|||pg/mL||Full Range|Geometric Mean
2575872|NCT02459418|Secondary|Baseline Corrected 17ß-Estrodiol (E2) Serum Exposure AUC(0-last)|"AUC(0-last) was estimated for baseline corrected E2 in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.~Geometric mean baseline corrected E2 exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PD time point after administration of AFOLIA or Gonal-f® RFF."|From 0 hours (predose) to 192 hours postdose.|This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with concentration data for determination of AUC(0-last) are included.|||pg*h/mL||Full Range|Geometric Mean
2575873|NCT02459418|Secondary|Baseline Corrected FSH Apparent Terminal Half-life|"Apparent terminal half-life was defined as ln2/apparent terminal rate constant (λz). λz is determined by linear regression of the terminal points of the log-linear concentration-time curve. Visual assessment was used to identify the terminal linear phase of the baseline corrected concentration-time profile. A minimum of 3 data points was used for determination.~Terminal half-life was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.~Geometric mean baseline corrected FSH exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF."|From 0 hours (predose) to 192 hours postdose.|This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured concentration at a scheduled PK or PD time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with suitable terminal phase profiles for determination of terminal half-life are included.|||hours||Full Range|Geometric Mean
2575874|NCT02459418|Secondary|Baseline Corrected Time to Reach Maximum FSH Serum Concentration (Tmax)|"Tmax was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.~Geometric mean was not calculated for Tmax and the non-transformed results are presented are for all subjects who received active study drug and had Tmax estimated in both periods."|From 0 hours (predose) to 192 hours postdose.|This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with Tmax estimated in both periods are included.|||hours||95% Confidence Interval|Median
2575875|NCT02459418|Secondary|Baseline Corrected FSH Area Under the Serum Concentration-time Curve Extrapolated to Infinity [AUC(0-∞)]|"AUC(0-∞) was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.~Geometric mean baseline corrected FSH exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF."|From 0 hours (predose) to 192 hours postdose.|This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with suitable terminal phase profiles for determination of AUC(0-∞) are included.|||ng*h/mL||Full Range|Geometric Mean
2575911|NCT02458287|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)|Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. Participants with their ADA titer levels >=6.23 were considered as ADA positive and participants with their nAb titer level >=1.58 were considered as nAb positive.|Baseline up to 18 weeks|Safety analysis set included all participants who received at least 1 dose of study treatment. Participants who received at least 1 dose of bococizumab were evaluable for this outcome measure. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2575876|NCT02459418|Primary|Baseline Corrected FSH Maximum Serum Concentration (Cmax)|"Cmax was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.~Geometric mean baseline corrected FSH exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF."|From 0 hours (predose) to 192 hours postdose.|This analysis was performed on the PKAS which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with concentration data for determination of Cmax are included.|||ng/mL||Full Range|Geometric Mean
2575877|NCT02459418|Primary|Baseline Corrected FSH Area Under the Serum Concentration-time Curve From Zero to the Last Quantifiable Measurement [AUC(0-last)]|"AUC(0-last) was estimated for baseline corrected FSH in serum by noncompartmental methods using actual elapsed time from dosing. Baseline corrected concentrations were determined by subtracting the baseline concentration (collected immediately prior to dosing in that period) from the postdose concentration.~Geometric mean baseline corrected FSH exposure results are presented for all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF."|From 0 (predose),0.5, 1, 3, 6, 9, 12, 16, 20, 21, 22, 23, 24, 25, 26, 27, 28, 48, 72, 96, 120, 144, 168 and 192 hours postdose.|Analysis was performed on the Pharmacokinetic Analysis Set (PKAS) which includes all subjects who received active study drug and had at least 1 measured and valid concentration at a scheduled PK time point after administration of AFOLIA or Gonal-f® RFF. Only subjects with concentration data for determination of AUC(0-last) are included.|||nanograms*hours/mL (ng*h/mL)||Full Range|Geometric Mean
2575878|NCT02459197|Secondary|For Osteoarthritic Patients Only: Patient's Change From Baseline of Osteoarthritic Physical Function, Pain and Stiffness as Assessed by Western Ontario and MacMaster (WOMAC) Scales From Baseline to End of Treatment|"The WOMAC (Bellamy et al., 1988) is a patient-rated instrument that measures OA symptoms.~The questionnaire contains 5 pain questions, 2 stiffness questions, and 17 physical function questions (24 questions total). Each question utilizes a 5-points Numeric Rating Scale (NRS) between 0-4; from 0=none to 4=extreme. Range of possible subscale scores: pain=0-20, stiffness=0-8 and physical function=0-68; higher scores for each subscale indicate worse outcomes.~The WOMAC was completed at each Visit except for Visit 5 by OA patients only."|Time zero equals baseline (Day-28 to Day-14) up to Day 29|Only OA sub-population of patients were included in the Analysis Population|||score on a scale||Standard Deviation|Mean
2575879|NCT02459197|Secondary|Patient's Change From Baseline of Heat Pain Threshold From Baseline to End of Treatment|celcius degree, arithmetic average of 6 tests.|Time zero equals baseline (Day 1) up to Day 29|3 patients who completed the study were excluded from the Analysis Population due to protocol violations. Therefore only 110 patients were included in the Analysis Population.|||°C||Standard Deviation|Mean
2575880|NCT02459197|Secondary|Patient's Change From Baseline of Investigator and Patient Global Assessment of Changes (IGAC and PGAC)|"IGAC and PGAC are subjective evaluations using a NRS with 0 meaning best condition and 10 worst condition"|Time zero equals baseline (Day-28 to Day-14) up to Day 29|3 patients who completed the study were excluded from the Analysis Population due to protocol violations. Therefore only 110 patients were included in the Analysis Population.|||score on a scale||Standard Deviation|Mean
2575881|NCT02459197|Secondary|Patient's Change From Baseline of Pain Severity as Measured by the Brief Pain Inventory (BPI)|BPI is a self-reported scale that measures the severity of pain and the interference of pain on function (Charles S. Cleeland © 2009). In the short form of BPI, there are 4 questions assessing worst pain, least pain, actual pain and average pain in the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. The interference scores range from 0 (does not interfere) to 10 (completely interferes).|Time zero equals baseline (Day-28 to Day-14) up to Day 29|3 patients who completed the study were excluded from the Analysis Population due to protocol violations. Therefore only 110 patients were included in the Analysis Population.|||score on a scale||Standard Deviation|Mean
2575882|NCT02459197|Primary|Patient's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Average Pain Scores (APS) During 4 Weeks of Treatment|11-point Numeric Rating Scale (NRS); the 11 NRS scale ranges from 0 (No pain) to 10 (pain as bad as you can imagine); the baseline APS (weekly mean of the daily average pain score) was computed on the 7 last days before Visit 2 with available APS values; similarly, the end-of-treatment APS (or APS Week 4) was computed on the 7 last days before Visit 4 with available APS values.|Time zero equals baseline (Day-28 to Day-14) up to Day 36|3 patients who completed the study were excluded from the Analysis Population due to protocol violations. Therefore only 110 patients were included in the Analysis Population.|||score on a scale||Standard Deviation|Mean
2575883|NCT02459119|Secondary|Number of Participants With Adverse Events|The Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 will be used for assessment of toxicities.|At the end of first treatment until 6 months following last treatment, an expected average of 10 months||||Participants|||Count of Participants
2575884|NCT02459119|Secondary|Rate of Progression-free Survival|"Duration of time from the start of treatment to time of progression or death, whichever comes first.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|From start of treatment to time of progression or death, assessed up to 6 months||||days||Standard Error|Mean
2575885|NCT02459119|Secondary|Overall Survival|Length of subject survival after starting study treatment|Baseline to 3 years||||days||Standard Error|Mean
2575925|NCT02458287|Primary|Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 150 mg Dose Group and Matched Placebo||Baseline, Week 12|Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||percent change||Standard Error|Least Squares Mean
2575926|NCT02457897|Secondary|Muscle Glucose Uptake||6 months||||μmol/min/100ml||Standard Deviation|Mean
2575886|NCT02459119|Secondary|Disease Response Rate|"The number of participants showing response at first restaging scan after the start of study treatment. The response will be assessed using tumor measurements which will be documented through CT scans, magnetic resonance imaging (MRI), and x-rays using the Response Evaluation Criteria in Solid Tumors (RECIST). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR., or similar definition that is accurate and appropriate"|Every 8 weeks until the time of disease progression upto 2 years||||Participants|||Count of Participants
2575887|NCT02459119|Primary|Number of Participants With Progression-free Survival at 6 Months|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Death is also considered as progression in the analysis.|Baseline to 6 months following start of treatment||||Participants|||Count of Participants
2575888|NCT02459093|Primary|Number of Participants With Wound Complications (Surgical Site Infection (SSI), Hematoma, Separation, Seroma, Etc)|Any wound disruption, fluid accumulation, separation, all CDC defined stages of surgical site infection (SSI)|30 days|As treated|||Participants|||Count of Participants
2575889|NCT02459093|Primary|Number of Participants With Wound Complications (Surgical Site Infection (SSI), Hematoma, Separation, Seroma, Etc)|Any wound disruption, fluid accumulation, separation, all CDC defined stages of surgical site infection (SSI)|30 days|Intent to treat analysis|||Participants|||Count of Participants
2575890|NCT02459080|Secondary|St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85|A Responder is defined as someone who experienced a decrease in SGRQ score of 4 or more units|Baseline to Day 85||||Participants|||Count of Participants
2575891|NCT02459080|Secondary|Percentage of Albuterol Rescue-free 24-hour Periods||1-3 Months||||Percentage of 24 hr periods||Standard Error|Least Squares Mean
2575892|NCT02459080|Secondary|Summary of Rescue Medication Use: Puffs Per Day||1-3 Months||||Puffs per Day||Standard Error|Least Squares Mean
2575893|NCT02459080|Secondary|Summary of Change From Baseline to Peak FEV1 After First Dose||0-2 hours after First Dose Day 1||||mL||Standard Error|Least Squares Mean
2575894|NCT02459080|Secondary|Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85||Days 15 to 85||||mL||Standard Error|Mean
2575895|NCT02459080|Primary|Change From Baseline in Trough FEV1 on Day 85||Day 85|Intent-to-treat (ITT) analysis set|||mL||Standard Error|Least Squares Mean
2575896|NCT02458768|Primary|Number of Retrieved Oocytes||36 hrs (±3 hrs) after administration of the ovulation stimulant|Per-Protocol Set|||Oocytes||Standard Deviation|Mean
2575897|NCT02458469|Secondary|Apnea-Hypopnea Index (AHI)|Randomized placebo-controlled cross-over study. Each subject was studied on three separate occasions: (1) Buspirone vs. Trazodone vs. placebo for 2 weeks; After the two-week treatment a polysomnogram (PSG) study was repeated to determine the AHI. (2) Cross over medication for two weeks was followed by a second PSG to determine the AHI followed by two weeks washout. (3) Cross over medication for two weeks was followed by another sleep study to determine the AHI.|Two weeks|Only 8 of the 15 enrolled participants finished all three medication arms (placebo, buspirone, trazodone) and were used in the final analysis.|||Events/Hour||Standard Deviation|Mean
2575898|NCT02458469|Primary|CO2 Reserve (Delta-PETCO2-AT)|Randomized placebo-controlled cross-over study. Each subject was studied on three separate occasions: (1) Buspirone vs. Trazodone vs. placebo for 2 weeks; After the two-week treatment a noninvasive nasal mechanical ventilation study was repeated to determine the hypocapnic apneic threshold. (2) Cross over medication for two weeks was followed by a second noninvasive nasal mechanical ventilation study to determine the CO2 reserve (Delta-PETCO2-AT) and hypocapnic apneic threshold followed by two weeks washout. (3) Cross over medication for two weeks was followed by another sleep study to determine the hypocapnic apneic threshold.|Two weeks|Only 8 of the 15 enrolled participants finished all three medication arms (placebo, buspirone, trazodone) and were used in the final analysis.|||mmHg||Standard Deviation|Mean
2575899|NCT02458365|Other Pre-specified|Number of Participants Experiencing Emotional Peer Violence During Follow-up|"See above. One or more incidents of peer emotional mistreatment experienced during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were not exposed to at least minimal risk for dating violence (see definition of minimal risk above); among 725 participants not exposed to risk, 44 were inadvertently administered the wrong measures and thus were excluded from analyses, leaving N = 681.|||participants|||Number
2575900|NCT02458365|Other Pre-specified|Number of Participants Perpetrating Emotional Peer Violence During Follow-up|"See above. One or more incidents of peer emotional mistreatment perpetrated during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were not exposed to at least minimal risk for dating violence (see definition of minimal risk above); among 725 participants not exposed to risk, 44 were inadvertently administered the wrong measures and thus were excluded from analyses, leaving N = 681.|||participants|||Number
2575901|NCT02458365|Other Pre-specified|Number of Participants Experiencing Physical Peer Violence During Follow-up|"See above. Cronbach's Alphas for the three victimization scales were .89 for emotional mistreatment, .89 for physical violence, and .93 for sexual coercion. One or more incidents of physical peer violence victimization during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were not exposed to at least minimal risk for dating violence (see definition of minimal risk above); among 725 participants not exposed to risk, 44 were inadvertently administered the wrong measures and thus were excluded from analyses, leaving N = 681.|||participants|||Number
2575924|NCT02458287|Primary|Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 0 (Day 1)|"A successful injection based on PAT was an injection where the participant answered yes to all the three questions: Were you able to inject your medicine? Has the blue bar moved across the window? Was the medicine not flowing after needle withdrawn?"|Week 0 (Day 1)|Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.|||percentage of injections|injections||Number
2575927|NCT02457897|Secondary|Muscle Glucose Uptake||2 weeks||||μmol/min/100ml||Standard Deviation|Mean
2575902|NCT02458365|Other Pre-specified|Number of Participants Perpetrating Physical Peer Violence During Follow-up|"Among participants not exposed to risk for dating violence, an 18-item measure assessed three types of peer violence perpetration and victimization (Levesque, 2007). Alphas for the three 3-item perpetrator scales are: .89 for emotional mistreatment, .89 for physical violence, and .94 for sexual coercion. At follow-up, in the spring and fall of 2010, the measure assessed peer violence experienced and perpetrated since January 1, 2010. Given the hierarchical structure of the perpetration measure, the physical violence and sexual coercion scales were combined to represent physical perpetration. One or more incidents of physical perpetration during the period in question were coded as yes, and no incidents coded as no."|One year|Participants who were not exposed to at least minimal risk for dating violence (see definition of minimal risk above); among 725 participants not exposed to risk, 44 were inadvertently administered the wrong measures and thus were excluded from analyses, leaving N = 681.|||participants|||Number
2575903|NCT02458365|Secondary|Number of Participants Experiencing Emotional Dating Violence During Follow-up|"See above.One or more incidents of emotional dating violence victimization during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were exposed to at least minimal risk for dating violence -- i.e., who had experienced or perpetrated emotional or physical dating violence in the year prior to the study, who were current daters at baseline, or who dated during the follow-up period.|||participants|||Number
2575904|NCT02458365|Secondary|Number of Participants Perpetrating Emotional Dating Violence During Follow-up|"See above.One or more incidents of emotional dating violence perpetration during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were exposed to at least minimal risk for dating violence -- i.e., who had experienced or perpetrated emotional or physical dating violence in the year prior to the study, who were current daters at baseline, or who dated during the follow-up period.|||participants|||Number
2575905|NCT02458365|Secondary|Number of Participants Experiencing Physical Dating Violence During Follow-up|"See above. Cronbach's Alphas for the five victimization scales were .87 for emotional mistreatment, .86 for controlling behavior, .83 for threats, .76 for physical violence, and .90 for sexual coercion. One or more incidents of physical dating violence victimization during the period in question were coded as yes, and no incidents coded as no)."|One year|Participants who were exposed to at least minimal risk for dating violence -- i.e., who had experienced or perpetrated emotional or physical dating violence in the year prior to the study, who were current daters at baseline, or who dated during the follow-up period.|||participants|||Number
2575906|NCT02458365|Primary|Number of Participants Perpetrating Physical Dating Violence During Follow-up|"A 30-item measure assessing five types of dating violence perpetration and victimization was developed to meet specific needs of this research (Levesque, 2007). Alphas for the five 3-item perpetrator scales are: .88 for emotional mistreatment, .87 for controlling behavior, .91 for threats, .92 for physical violence, and .94 for sexual coercion. At follow-up, in the spring and fall of 2010, the measure assessed dating violence perpetrated and experienced since January 1, 2010. Given the hierarchical structure of the perpetration measure, the emotional mistreatment and controlling behavior scales were combined to represent emotional dating violence perpetration, and the threats, physical violence, and sexual coercion scales were combined to represent physical perpetration. Given extreme non-normal distributions, the two measures were then dichotomized. One or more incidents of physical perpetration during the period in question were coded as yes, and no incidents as no."|One year|Participants who were exposed to at least minimal risk for dating violence -- i.e., who had experienced or perpetrated emotional or physical dating violence in the year prior to the study, who were current daters at baseline, or who dated during the follow-up period.|||participants|||Number
2575907|NCT02458352|Primary|Intra-class Correlation Coefficient Between Segmental Relative Tracer Uptake From SPECT Datasets Reconstructed With AC Maps Based on Ultra-Low-Dose and Standard Dose CT|For every patient, the CT images from 120 and 70 kVp-CT scans were used to create CTAC maps which were then used to reconstruct SPECT images, displayed as a 17-segment model polar plot with normalized percent tracer uptake given for every segment. Intra-class correlation was then applied to compare segmental relative tracer uptake. Analysis and the resulting correlation coefficient of 0.987 basically demonstrates interchangeability between the two datasets.|1 day|2/105 participants were not analyzed due to corrupt datasets.|||Intraclass correlation coefficient|||Number
2575908|NCT02458352|Primary|Agreement and Correlation of Coronary Artery Calcium Score Obtained From Ultra-low-dose and Standard CT|"CAC and BA limits of agreement between coronary artery calcium score obtained from ultra-low-dose and standard CT.~Coronary artery calcium (CAC) is a measure for quantification of coronary artery calcification based on non-contrast enhanced CT, ranging from 0 (no calcifications) to infinite. It is an arbitrary unit. Increasing CAC means higher amounts of coronary artery calcifications and is associated with worse prognosis.~Bland-Altman (BA) analysis is a statistical method to compare two modalities or techniques assessing the same measure. Limits of agreement is defined as +/- twice the standard deviation of the differences between the reference method and the new modality/technique. Broader limits of agreement mean less accurate results obtained by the new modality/techniqe, while a 0 BA limit of agreement would theoretically reflect perfect agreement."|1 days|2/105 participants were not analyzed due to corrupt datasets.|||Agatston score||Inter-Quartile Range|Median
2575909|NCT02458287|Secondary|Plasma Concentration of Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) at Week 12|PCSK9 is an enzyme encoded by the PCSK9 gene in humans on chromosome. It is the 9th member of the proprotein convertase family of proteins that activate other proteins.|Week 12|Safety analysis set included all participants who received at least 1 dose of study treatment. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||nanogram per milliliter||Standard Deviation|Mean
2575910|NCT02458287|Secondary|Plasma Concentration of Bococizumab at Week 12||Week 12|Analysis set included all participants who received at least one dose of study medication. Participants who received at least 1 dose of Bococizumab were evaluable for this outcome measure. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||microgram per milliliter||Standard Deviation|Mean
2575928|NCT02457897|Primary|Hemoglobin A1C||6 months||||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2575929|NCT02457897|Primary|Total Body Glucose Disposal in the Fasting State||2 weeks||||μmol/kg LBM (Lean Body Mass)/min||Standard Deviation|Mean
2575912|NCT02458287|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug up to the follow up visit (up to 18 weeks), that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline up to 18 weeks|Safety analysis set included all participants who received at least one dose of study medication.|||participants|||Number
2575913|NCT02458287|Secondary|Percent Change From Baseline in Fasting Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12||Baseline, Week 12|Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||percent change||Standard Error|Least Squares Mean
2575914|NCT02458287|Secondary|Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12||Baseline, Week 12|Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||percent change||Standard Error|Least Squares Mean
2575915|NCT02458287|Secondary|Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12||Baseline, Week 12|Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||percent change||Standard Error|Least Squares Mean
2575916|NCT02458287|Secondary|Percent Change From Baseline at Week 12 in Fasting Low Density Lipoprotein Cholesterol (LDL-C) Level for Bococizumab 75 mg Dose Group and Matched Placebo||Baseline, Week 12|Full analysis set included all participants who were randomized. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||percent change||Standard Error|Least Squares Mean
2575917|NCT02458287|Secondary|Percentage of Injections That Met the Definition for Successful Assessment Using the Observer Assessment Tool (OAT) for Bococizumab 150 mg Dose, Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 4 and 8|"As per the OAT, a 'successful' injection was based on observer's response for the question - Was the administration successful?''. Observer's response being 'Yes' corresponded to a successful injection."|Week 0 (Day 1), 4, 8|Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms as pre-specified in protocol.|||percentage of injections|injections||Number
2575918|NCT02458287|Secondary|Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 75 mg Dose Group and Combined Bococizumab 150 mg and 75 mg Dose Group at Week 0 (Day 1), 2, 4, 6, 8 and 10|"A successful injection based on PAT was an injection where the participant answered yes to all the three questions: Were you able to inject your medicine? Has the blue bar moved across the window? Was the medicine not flowing after needle withdrawn?"|Week 0 (Day 1), 2, 4, 6, 8, 10|Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.|||percentage of injections|injections||Number
2575919|NCT02458287|Primary|Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 10|"A successful injection based on PAT was an injection where the participant answered yes to all the three questions: Were you able to inject your medicine? Has the blue bar moved across the window? Was the medicine not flowing after needle withdrawn?"|Week 10|Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.|||percentage of injections|injections||Number
2575920|NCT02458287|Primary|Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 8|"A successful injection based on PAT was an injection where the participant answered yes to all the three questions: Were you able to inject your medicine? Has the blue bar moved across the window? Was the medicine not flowing after needle withdrawn?"|Week 8|Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.|||percentage of injections|injections||Number
2575921|NCT02458287|Primary|Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 6|"A successful injection based on PAT was an injection where the participant answered yes to all the three questions: Were you able to inject your medicine? Has the blue bar moved across the window? Was the medicine not flowing after needle withdrawn?"|Week 6|Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.|||percentage of injections|injections||Number
2575922|NCT02458287|Primary|Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 4|"A successful injection based on PAT was an injection where the participant answered yes to all the three questions: Were you able to inject your medicine? Has the blue bar moved across the window? Was the medicine not flowing after needle withdrawn?"|Week 4|Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.|||percentage of injections|injections||Number
2575923|NCT02458287|Primary|Percentage of Injections That Met the Definition for Successful Assessment Using the Participant Assessment Tool (PAT) for Bococizumab 150 mg Dose Group at Week 2|"A successful injection based on PAT was an injection where the participant answered yes to all the three questions: Were you able to inject your medicine? Has the blue bar moved across the window? Was the medicine not flowing after needle withdrawn?"|Week 2|Full analysis set included all participants who were randomized. Data for this outcome measure was not planned to be analyzed for placebo arms, as pre-specified in protocol.|||percentage of injections|injections||Number
2577315|NCT02441218|Secondary|Hospitalisation for Worsening Heart Failure||From the date of randomization to the date of first documented hospitalisation, up to 42 months||||participants|||Number
2575930|NCT02457819|Secondary|Change From Baseline, in Clinical Global Impression-Severity of Illness (CGI S) Score.|The CGI-S scale, modified captures the clinician's rating of observed and reported ADHD symptoms, behavior, and function over the past 7 days. The CGI-S is rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill subjects.|26 weeks|safety population|||units on a scale||Standard Deviation|Mean
2575931|NCT02457819|Secondary|Change From Baseline, in Attention Deficit Hyperactivity Disorder Rating Scale, Version IV, Home Version, (ADHD RS IV HV) Total Score.|"The ADHD RS-IV HV is a validated scale that consists of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria and is also consistent with DSM-5 criteria.~Each item is scored from a range of zero (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from zero to 54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even number items 2 through 18) and inattentiveness (odd number items 1 through 17)."|26 Weeks|safety population|||units on a scale||Standard Deviation|Mean
2575932|NCT02457819|Primary|The Incidence of Overall Adverse Events, AEs , Serious Adverse Envents,(or SAEs), and AEs (or SAEs) Leading to Discontinuation|Overall adverse events, AEs , serious adverse envents,(or SAEs), and AEs (or SAEs) leading to discontinuation.|26 Weeks|safety population|||adverse events|||Number
2575933|NCT02457793|Secondary|Change From Baseline in Tumor Tissue Biomarkers||Up to 15 months|Data for this measure were not collected.||||||
2575934|NCT02457793|Secondary|Change From Baseline in Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)||Baseline, Day 15|Data for this measure were not collected.||||||
2575935|NCT02457793|Secondary|Mean Terminal Half-life (t1/2)||Up to day 22 of study|Data for this measure were not collected.||||||
2575936|NCT02457793|Secondary|Mean Accumulation Ratio||Pre-dose Day 1 Cycle 1, 2, 3, Day 18, 21 Cycle 1; post-dose 0.5, 1, 2, 3, 4, 6 hours Day 1, 18, 21 Cycle 1; Day 2, 15, 19, 22, Cycle 1|Data for this measure were not collected.||||||
2575937|NCT02457793|Secondary|Total Exposure (AUC From Time 0 to 24 Hour After Dose) for Cobimetinib||0 to 24 hours post-dose (Up to Day 22)|Data are reported for evaluable participants.|||ng x hr/mL||Geometric Coefficient of Variation|Geometric Mean
2575938|NCT02457793|Secondary|Total Exposure (AUC From Time 0 to 24 Hour After Dose) for GDC-0994|Data are reported for evaluable participants.|0 to 24 hours post-dose (Up to Day 22)|Data are reported for evaluable participants.|||hr x microM||Geometric Coefficient of Variation|Geometric Mean
2575939|NCT02457793|Secondary|Median Time to Maximum Serum Concentration (Tmax) for Cobimetinib||Up to Day 22|Data are reported for evaluable participants.|||hours||Full Range|Median
2575940|NCT02457793|Secondary|Maximum Serum Concentration (Cmax) for Cobimetinib||Up to Day 22|Data are reported for evaluable participants.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2575941|NCT02457793|Secondary|Median Time to Maximum Serum Concentration (Tmax) for GDC-0994||Up to Day 22|Data are reported for evaluable participants.|||hours||Full Range|Mean
2575942|NCT02457793|Secondary|Maximum Serum Concentration (Cmax) for GDC-0994||Up to Day 22|Data are reported for evaluable participants.|||micromoles||Geometric Coefficient of Variation|Geometric Mean
2575943|NCT02457793|Primary|Mean Change From Baseline in Weight||Baseline, up to 15 months|All participants. Data are reported for evaluable participants.|||kg||Standard Deviation|Mean
2575944|NCT02457793|Primary|Mean Change From Baseline in Temperature||Baseline, up to 15 months|All participants. Data are reported for evaluable participants.|||degrees Celsius||Standard Deviation|Mean
2575945|NCT02457793|Primary|Mean Change From Baseline in Systolic Blood Pressure||Baseline, up to 15 months|All participants. Data are reported for evaluable participants.|||mmHg||Standard Deviation|Mean
2575946|NCT02457793|Primary|Mean Change From Baseline in Respiratory Rate||Baseline, up to 15 months|All participants. Data are reported for evaluable participants.|||breaths per minute||Standard Deviation|Mean
2575947|NCT02457793|Primary|Mean Change From Baseline in Pulse Rate||Baseline, up to 15 months|All participants. Data are reported for evaluable participants.|||beats per minute||Standard Deviation|Mean
2575948|NCT02457793|Primary|Mean Change From Baseline in Lean Body Mass||Baseline, Day 15|All participants. Data are reported for evaluable participants.|||kilograms (kg)||Standard Deviation|Mean
2575949|NCT02457793|Primary|Mean Change From Baseline in Diastolic Blood Pressure||Baseline, up to 15 months|All participants. Data are reported for evaluable participants.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2575950|NCT02457793|Primary|Percentage of Participants With Laboratory Abnormalities|"Laboratory abnormalities were graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0.~SGPT/ALT - serum glutamic-pyruvic transaminase/alanine aminotransferase; SGOT/AST - serum glutamic oxaloacetic transaminase/aspartate aminotransferase"|Up to 15 months|All participants. Data are reported for evaluable participants.|||percentage of participants|||Number
2575951|NCT02457793|Primary|Percentage of Participants With at Least One Serious Adverse Event (SAE)|A SAE is any experience that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant.|Up to 15 months|All participants.|||percentage of participants|||Number
2575952|NCT02457793|Primary|Percentage of Participants With at Least One Adverse Event of Special Interest|AESIs were graded per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0. AESIs included the following: Grade ≥ 1 retinal vein occlusion; Grade ≥ 2 visual disturbances (including events suggestive of serous retinopathy); Grade ≥ 3 rash for > 7 days; Grade ≥ 3 diarrhea for > 3 days; Grade ≥ 2 left ventricular ejection fraction (LVEF) decrease; Grade 3 hepatotoxicity; any dose-limiting toxicity (DLT); cases of potential drug-induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (AST > 3 × baseline value [and above the upper limit of normal, ULN]) in combination with either an elevated bilirubin ( > 2 × ULN) or clinical jaundice; or suspected transmission of an infectious agent by either study drug.|Up to 15 months|All participants.|||percentage of participants|||Number
2577316|NCT02441218|Secondary|Cardiovascular Death|Component of the primary composite endpoint|From the date of randomization until the date of death, up to 42 months||||participants|||Number
2575955|NCT02457728|Primary|Number of Participants With Safe Fixation of Mesh and Closure of Peritoneum by Clinical Investigation During Hospital Stay and Telephone Interview at Six Weeks Postoperatively.|Clinical examination during hospital stay to rule out any bowel obstruction due to insufficient closure of peritoneum. Telephone interview at six weeks postoperatively to record any adverse events in the early postoperative period such as recurrent hernia, pain or bowel obstruction.|During hospitalization and 6 weeks after surgery.||||participants|||Number
2575956|NCT02457637|Other Pre-specified|Biochemical Parameters|Serum bilirubin, international normalized ratio, serum creatinine, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, γ-Glutamyltransferase, white blood cell count, neutrophil count and hemoglobin will be collected and reported at 1, 4, 7, 14, 21 and 28 days (or last visit) during patients' hospitalization.|Up to 28 days||2019-12-31|12/2019||||
2575957|NCT02457637|Other Pre-specified|Models for Disease Severity|"MELD score, MELD-Na score, CLIF-SOFA score, SOFA score and APACHE scores will be calculated and reported at 1, 4, 7, 14, 21 and 28 days (or last visit) during patients' hospitalization.~MELD：Model for end-stage liver disease MELD-Na： Model for end-stage liver disease - sodium SOFA：sequential organ failure assessment CLIF-SOFA：chronic liver failure-sequential organ failure assessment APACHE：Acute Physiology And Chronic Health Evaluation"|Up to 28 days|||||||
2575958|NCT02457637|Other Pre-specified|The Appearance and Number of Organ Failure|The appearance and number of organ failure（including liver, coagulation, renal, circulation, brain, respiratory system） will be evaluated and reported at 1, 4, 7, 14, 21 and 28 days (or last visit)during patients' hospitalization.|Up to 28 days||||Participants|||Count of Participants
2575959|NCT02457637|Secondary|180-day Mortality Rate and Liver Transplantation Rate|Mortality will be respectively calculated together with the liver transplantation rate (as the rate of ''incidence'')and independently (as the ''liver transplantation free mortality'') respectively.|up to 180 days|Mortality will be respectively calculated together with the liver transplantation rate (as the rate of ''incidence'')and independently (as the ''liver transplantation free mortality'') respectively.|||Participants|||Count of Participants
2575960|NCT02457637|Secondary|90-day Mortality Rates, 90-day Liver Transplantation Free Mortality and Liver Transplantation Rate|liver-transplantation free mortality refers to number of participants who died in the absence of receiving a liver transplant divided by number of participants without liver transplant.|up to 90 days|Mortality will be respectively calculated together with the liver transplantation rate (as the rate of ''incidence'')and independently (as the ''liver transplantation free mortality'') respectively.|||Participants|||Count of Participants
2575961|NCT02457637|Primary|28-day Mortality,28-day Liver-transplantation Free Mortality& 28-day Liver Transplantation Rate|liver-transplantation free mortality refers to number of participants who died in the absence of receiving a liver transplant divided by number of participants without liver transplant.|up to 28 days|liver-transplantation free mortality refers to number of participants who died in the absence of receiving a liver transplant divided by liver-transplantation free participants|||Participants|||Count of Participants
2575962|NCT02457611|Secondary|Percent Change From Baseline in CD4 T-cell Count at the End of Treatment and at Posttreatment Week 4||Baseline; Week 6; Posttreatment Week 4|Participants in the Safety Analysis Set with available data were analyzed.|||percent change||Standard Deviation|Mean
2575963|NCT02457611|Secondary|Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4||Weeks 2, 4, 6, and Posttreatment Week 4|Participants in the Safety Analysis Set who had HIV-1 RNA < 50 copies/mL at Baseline were analyzed.|||percentage of participants||95% Confidence Interval|Number
2575964|NCT02457611|Secondary|Change in HIV RNA From Day 1 to End of Treatment as Assessed by Proportion of Participants Who Had Confirmed HIV Virologic Rebound During the Study.|Participants with HIV virologic rebound was defined as participants with at least two HIV RNA ≥ 400 copies/mL at 2 consecutive post-baseline visits which are at least 2 weeks apart based on actual dates.|Day 1; Week 6|Safety Analysis Set|||Participants|||Count of Participants
2575965|NCT02457611|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure~confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),~confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound),~HCV RNA persistently ≥ LLOQ through end of treatment (ie, nonresponse)~Relapse~HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement"|Up to Posttreatment Week 12|Full Analysis Set|||percentage of participants|||Number
2575966|NCT02457611|Secondary|Change From Baseline in HCV RNA at Weeks 2, 4, and 6||Baseline; Weeks 2, 4, and 6|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2575967|NCT02457611|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Weeks 2, 4, and 6|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2575968|NCT02457611|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Study Treatment (SVR4)|SVR4 was defined as HCV RNA < LLOQ 4 weeks after the last dose of study drug.|Posttreatment Week 4|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2575969|NCT02457611|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 6 weeks|Safety Analysis Set|||percentage of participants|||Number
2575970|NCT02457611|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Completion of Treatment (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants with genotype 1 or 4 HCV infection who were enrolled into the study and received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2575971|NCT02457546|Other Pre-specified|Safety Endpoint: Intra-operative CSF Leakage Follow Final Valsalva|Intra-operative CSF leakage follow final Valsalva|Intraoperatively, after final Valsalva maneuver|No Valsalva maneuver performed in 2 participants in the Evicel Arm and 1 participant in the DuraSeal Arm|||Participants|||Count of Participants
2576045|NCT02455076|Secondary|Incidence of Hyperglycemic Events Inpatient|Percent of readings with hyperglycemia (blood glucose levels > 240 mg/dL)|Duration of hospital stay, an expected average of 10 days||||percentage of readings||Standard Deviation|Mean
2575972|NCT02457546|Primary|Primary Effectiveness Endpoint Success Number of Successes (Subjects That Had no Inter-operative CSF Leak Following Valsalva Maneuver and no CSF Leak or Pseudomeningocele in the Surgical Area During the 30-day Follow-up Period)|The primary endpoint was the proportion of subjects that had no inter-operative CSF leak following Valsalva maneuver and no CSF leak or pseudomeningocele in the surgical area during the 30-day follow-up period|Intraoperatively through 30-day follow-up|Per Protocol Set|||Participants|||Count of Participants
2575973|NCT02457260|Secondary|Serology-platelet Bioenergetics-1|Platelet bioenergetics (using Seahorse XF analysis), i.e., extracellular acidification rate.|Baseline; PRE and 4 weeks; POST|Patients that completed pre post testing in each of the three arms were include in analysis. 6 subjects withdrawn from the study.|||mpH/min||Standard Deviation|Mean
2575974|NCT02457260|Secondary|Serology-plasma Nitrite and Nitrate|plasma nitrite and plasma nitrate levels pre and post 4 week intervention|Baseline; PRE and 4 weeks; POST|On analysis of data for this report it was found that three control samples had been missed on initial running of nitrate/nitrite bring the N=7 for that assessment. 6 subjects withdrawn from the study.|||µm||Standard Deviation|Mean
2575975|NCT02457260|Secondary|Serology-Inflammatory Marker|Inflammatory marker (C-reactive protein [CRP])|Baseline; PRE and 4 weeks; POST|Patients that completed pre post testing in each of the three arms were include in analysis. 6 subjects withdrawn from the study.|||mg/L||Standard Deviation|Mean
2575976|NCT02457260|Secondary|Quality of Life Assessment- In Heart Failure|Kansas City Cardiomyopathy Questionnaire (KCCQ)- is a standard tool to assess the quality of life of the heart failure patients. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains with the higher the score (0-100) the better the health status.|Baseline; PRE and 4 weeks; POST|Kansas City Cardiomyopathy Questionnaire (KCCQ)- is a standard tool to assess the quality of life of the heart failure patients. Control patients were not assessed via KCCQ given it is not a valid tool for healthy. All HF patients that completed pre and post assessment were analyzed. 6 subjects withdrawn from the study.|||scores on a scale||Standard Deviation|Mean
2575977|NCT02457260|Secondary|Measures of Physical Function- Balance|Balance was assessed as part of the short performance physical battery (SPPB). This assessment evaluates three components of static stand (stands with their feet together), semi tandem (stand with the heal of one foot beside the toe of the other foot), Tandem (stands with one foot directly in front of the other). Each test is held for as many seconds as they can up to ten seconds. Static and semi tandem if held for 10 second counts as 1 point if not held it is 0 points, tandem stand if held for 10 second is 2 points, if held for 3 to9.99 it is 1 point, otherwise 0 points. Total points are added up for all balance tests for a composite score with the higher the score the better and maximum being 4, minimum 0.|Baseline; PRE and 4 weeks; POST|All patients that have both pre and post data were assessed for all three groups. 6 subjects withdrawn from the study.|||score on a scale||Standard Deviation|Mean
2575978|NCT02457260|Secondary|Measures of Physical Function- Handgrip|Handgrip is used as a measure of upper body strength. three trials on each hand were completed with the patient seated and the arm at a right angle. For the purposes of this analysis all trials were averaged together.|Baseline; PRE and 4 weeks; POST|All patients that have both pre and post data were assessed for all three groups. 6 subjects withdrawn from the study.|||kg||Standard Deviation|Mean
2575979|NCT02457260|Secondary|Measures of Physical Function- Gait Speed|4 meter gait speed assessed as part of the short performance physical battery (SPPB). This assessment evaluates how long it take a person can cover four meters at their usual walking speed from a stop when a person says go. This was completed twice to find the fastest speed was used as the variable.|Baseline; PRE and 4 weeks; POST|All patients that have both pre and post data were assessed for all three groups. 6 subjects withdrawn from the study.|||seconds||Standard Deviation|Mean
2575980|NCT02457260|Secondary|Measures of Physical Function- Cardiopulmonary Exercise Test (CPX)|Continuous metabolic gas collection or a cardiopulmonary exercise test occurred during a constant speed-steady state treadmill walking protocol (1.5mph at a 0% grade) for 5 minutes. During the final minute of the walking protocol oxygen consumption (VO2) was assessed to determined if the patient reached steady state VO2. Steady state VO2 was assessed by a less than 5% change in VO2 for a 30 second period of time. The 30 second average time is represented below in units of measure ml/kg/min. This is to show change in efficiency of performance of the constant speed test a decrease in VO2 from pre to post indicates greater efficiency.|Baseline; PRE and 4 weeks; POST|All patients that have both pre and post data were assessed for all three groups. 6 subjects withdrawn from the study.|||ml/kg/min||Standard Deviation|Mean
2575981|NCT02457260|Secondary|Serology-platelet Bioenergetics|Platelet bioenergetics (using Seahorse XF analysis), i.e., including glycolytic(OLIGO) as well as basal and maximal respiratory rates and extracellular acidification rate.|Baseline; PRE and 4 weeks; POST|Patients that completed pre post testing in each of the three arms were include in analysis. 6 subjects withdrawn from the study.|||pmol/minute||Standard Deviation|Mean
2575982|NCT02457260|Primary|Skeletal Muscle Bioenergetics - Mitochondrial Function|Obtained via analysis of skeletal muscle biopsy of the vastus lateralis, Mitochondrial function was assessed using respirometry (State 3.12).|Baseline; PRE and 4 weeks; POST|2 Controls, 1 HFpEF and 1 HFrEF have no data for mitochondrial function due to no FCCP response or potential cytochrome c response. 6 subjects withdrawn from the study.|||nmol O / sec/ mg||Standard Deviation|Mean
2575983|NCT02457260|Primary|Skeletal Muscle Bioenergetics- Polymerase Chain Reaction (PCR)|Obtained via analysis of skeletal muscle biopsy of the vastus lateralis, Polymerase chain reaction (PCR) to assess pertinent gene expression within the pathways of ubiquitin [muscle ring finger protein 1 (MuRF), Atrogin1, Forkhead Box 03 (FoxO)], additionally Fibronectin type III domain-containing protein 5, the precursor of irisin (FNDC5), Peroxisome proliferator-activated receptor gamma co activator 1-alpha (PGC1α), and Sirtuin 3 were assessed.|Baseline; PRE and 4 weeks; POST|Health Control- 2 and 1 HFrEF participants have missing data for the gene analysis due to muscle samples not providing a clean reference value for inclusion of data analysis.. 6 subjects withdrawn from the study.|||Relative Expression||Standard Deviation|Mean
2576015|NCT02455388|Secondary|Diagnostic Value of d13C Biomarker|Determine diagnostic value of d13C biomarker using fingerstick blood. The area under the ROC was used as a measure for the diagnostic accuracy of the d13C biomarker, with values closer to 1.0 indicating greater ability to distinguish between low and high added sugar and sugar sweetened beverage consumers.|2-3 weeks||||Area under the ROC curve||95% Confidence Interval|Number
2575984|NCT02457247|Secondary|Product Tolerability Expressed as the Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event Within Each Test Group|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 to Day 28|The Safety Analysis Set included all randomized participants who received at least 1 dose of study medication.|||percentage of participants|||Number
2575985|NCT02457247|Secondary|Product Acceptability After Each 14 Day Dosing Period Within Each Test Group|Product acceptability was assessed by a 6 item questionnaire evaluating the characteristics of the product: gritty, chalky, sweet, ease of chew, ease of swallow and sticky. Using a 100 mm visual analog scale (VAS) the participant put a vertical line through each horizontal line that best describes their level of agreement with each item using a 0 to 100 scale where: 0=far left of the line (best) to 100= far right of the line (worst). Linear mixed model was used for analysis with treatment and period as fixed effects and participants as a random effect.|Day 14 and Day 28|The FAS included all randomized participants.|||mm||Standard Error|Least Squares Mean
2575986|NCT02457247|Primary|Percentage of Participants With a Preference for Each Treatment Within Each Test Group|Preference was assessed by a 3 box questionnaire. Participants checked off one of the boxes: I prefer the first product that was tested, I prefer the second product that was tested or I have no preference. Test Group 1 (United Kingdom): Calcichew D3 is 500/400 and the comparator is Adcal-D3. Test Group 2 (Germany): Calcichew D3 is 500/800 and the comparator is Kalcipos-D.|Day 28|All randomized participants from the Full Analysis Set (FAS) who received at least 1 dose of study medication and responded to the preference questionnaire.|||percentage of participants|||Number
2575987|NCT02457195|Primary|Number of Participants With Complete Response (CR), No PONV Symptoms, Nausea|Composite measure consisting of complete response (CR), defined as no emetic episode and no rescue medication; the proportions of patients with no emesis and no additional rescue medication in the 120 hours following the completion of surgical procedure.|24 hrs, 48 hrs, 72 hrs and 120 hrs|Those that completed the current study|||Participants|||Count of Participants
2575988|NCT02457182|Secondary|Pain Self-Efficacy Scale (PSEQ)|"The PSEQ is a scale describing how patients rate their abilities to complete daily activities.~It is a 60 point scale (scores range from 0-60) composed of 10 questions. Higher numbers signify better functioning or less limit by disease. A total score is calculating by summing individual items."|Baseline and within 2 weeks of 8-week class ending||||units on a scale||Standard Deviation|Mean
2575989|NCT02457182|Secondary|Female Sexual Function Index (FSFI)|"The FSFI measures sexual function. It is composed of 6 individual domain scores (desire, arousal, lubrication, orgasm, satisfaction and pain), which are summed to create a total score. Higher scores indicate better sexual function.~Ranges:~Desire 2-10 Arousal 0-20 Lubrication 0-20 Orgasm 0-15 Satisfaction 2-15 Pain 0-15 Total score ranges from 4-95 and is calculated by adding the 6 domains together. Again, higher scores indicate better sexual function."|Baseline and within 2 weeks of 8-week class ending||||units on a scale||Standard Deviation|Mean
2575990|NCT02457182|Secondary|Short Form Health Survey (SF-12)|The short form health survey (SF-12) is a scale used to evaluate chronic conditions. It is composed of a mental component and physical component. Each is made up of 12 questions totaling a score of 100 points. A zero score indicates the lowest level of health measured and 100 indicates the highest level of health.|Baseline and within 2 weeks of 8-week class ending||||units on a scale||Standard Deviation|Mean
2575991|NCT02457182|Secondary|Visual Analog (VAS) Pain Scale|The VAS scale is a 10-point scale ranging from 0 (no pain) to 10 (unbearable pain). 0 is considered better while 10 is considered worse.|Baseline and within 2 weeks of 8-week class ending||||units on a scale||Standard Deviation|Mean
2575992|NCT02457182|Secondary|O'Leary Sant Symptom Problem Index (OSPI)|"The OSPI is a Interstitial cystitis (IC/BPS)-specific scale composed of the symptom index and problem index as well as a total, which sums the symptom and problem scores caused by IC/BPS.~Symptom scores range from 0-21. Problem scores range from 0-16 Higher scores indicate a worse condition. Total scores range 0-37, with higher scores indicating a worse condition."|Baseline and within 2 weeks of 8-week class ending||||units on a scale||Standard Deviation|Mean
2575993|NCT02457182|Primary|Global Response Assessment (GRA)|The GRA is a 7-point scale, with scores ranging from markedly, moderately or slightly worse to slightly, moderately or markedly improved. This measure is used in many types of research and is not specific to IC/BPS.|Within 2 weeks of 8-week class ending||||participants|||Number
2575994|NCT02457065|Primary|"Influence of a Melanoma Survivor Plaque on the Survivor's and Broader Family's Skin Cancer Prevention Activity."|"Subjects filled out a survey when they enrolled in the study assessing their skin cancer prevention behaviors. The investigators randomly gave some subjects a Melanoma Survivor plaque. After 6-12 months, the subjects again filled out a survey assessing their skin cancer prevention behaviors. The investigators analyzed the difference in each subject's responses to the same survey questions over time. The investigators then analyzed the difference between the responses of the subjects who saw the plaque and the subjects who did not see the plaque to discern the influence of the plaque on skin cancer prevention behaviors. Survey questions asked the patient and a family member of theirs to comment on patient and familial sun exposure and cancer screening activity. Subjects self-reported if the their behavior changed over time."|6-12 months between time of completion of first survey and second survey.|Survivors of primary cutaneous melanoma less than 4.0 mm in depth who came through the Dermatology Clinic at Dartmouth-Hitchcock Medical Center, voluntarily chose to participate in the study after being informed of the nature of the research, and then completed the follow up survey 6-12 months after their initial enrollment.|||Participants|||Count of Participants
2575995|NCT02457065|Primary|Influence of a Patient's Melanoma Diagnosis on the Survivor's and Broader Family's Skin Cancer Prevention Activity.|Subjects filled out a survey when they enrolled in the study assessing their skin cancer prevention behaviors. Survey questions asked the patient and a family member of theirs to comment on patient and familial sun exposure and cancer screening activity before and after the patient's diagnosis with primary melanoma. Subjects self-reported if the diagnosis changed their behavior.|Collected via a survey administered immediately after a subject enrolled in the study.|Survivors of primary cutaneous melanoma less than 4.0 mm in depth who came through the Dermatology Clinic at Dartmouth-Hitchcock Medical Center and voluntarily chose to participate in the study after being informed of the nature of the research.|||Participants|||Count of Participants
2575998|NCT02456740|Secondary|Change From Baseline in Mean Monthly Average Impact on Everyday Activities Score Measured by MPFID in the Last 3 Months of the Double-blind Treatment Phase|"The Migraine Physical Function Impact Diary (MPFID) is a self-administered 13-item instrument measuring physical functioning. It has two domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and one stand-alone global question. Participants completed the MPFID daily in an electronic diary based on the past 24 hours. Participants responded to each item on a 5-point scale, with difficulty items ranging from Without any difficulty (1) to Unable to do (5) and frequency items ranging from None of the time (1) to All of the time (5). For each domain, the scores were calculated as the sum of the responses and rescaled to 0 - 100, with higher scores representing greater impact of migraine.~Change from baseline was calculated as (mean monthly impact on everyday activities scores as measured by the MPFID over the last 3 months of the double-blind treatment period) - (baseline monthly impact on everyday activities scores as measured by the MPFID)."|4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set including participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in MPFID average impact on everyday activities domain score in the double-blind treatment phase.|||units on a scale||Standard Error|Least Squares Mean
2575999|NCT02456740|Secondary|Change From Baseline in Mean Monthly Average Physical Impairment Domain Score Measured by MPFID in the Last 3 Months of the Double-blind Treatment Phase|"The Migraine Physical Function Impact Diary (MPFID) is a self-administered 13-item instrument measuring physical functioning. It has two domains, Impact on Everyday Activities (7 items) and Physical Impairment (5 items), and one stand-alone global question. Participants completed the MPFID daily in an electronic diary based on the past 24 hours. Participants responded to each item on a 5-point scale, with difficulty items ranging from Without any difficulty (1) to Unable to do (5) and frequency items ranging from None of the time (1) to All of the time (5). For each domain, the scores were calculated as the sum of the responses and rescaled to 0 - 100, with higher scores representing greater impact of migraine.~Change from baseline was calculated as (mean monthly average physical impairment scores as measured by the MPFID over the last 3 months of the double-blind treatment period) - (baseline monthly average physical impairment scores as measured by the MPFID)."|4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set including participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in MPFID average physical impairment domain score in the double-blind treatment phase.|||units on a scale||Standard Error|Least Squares Mean
2576000|NCT02456740|Secondary|Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days to the Last 3 Months of the Double-blind Treatment Period|"Monthly acute migraine-specific medication treatment days is the number of days on which migraine specific medications were used between monthly doses of study drug. Migraine-specific medications includes two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications.~The change from baseline in monthly acute migraine-specific treatment days was calculated as the average number of migraine-specific treatment days per month during the last 3 months of the 24-week double-blind treatment phase - the number of migraine-specific treatment days during the 4-week baseline phase."|4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set which includes participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in monthly acute migraine-specific treatment days in the double-blind treatment phase.|||Acute migraine-specific med days/mo||Standard Error|Least Squares Mean
2576001|NCT02456740|Secondary|Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days in the Last 3 Months of the Double-blind Treatment Phase|"A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura.~At least a 50% reduction from baseline in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the last 3 months (mean of months 4, 5 and 6) of the 24-week double-blind treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%."|4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set which includes participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in monthly migraine days in the double-blind treatment phase. Participants with missing data at months 4, 5, and 6 were counted as non-responders.|||percentage of participants|||Number
2576002|NCT02456740|Primary|Change From Baseline in Mean Monthly Migraine Days to the Last 3 Months of the Double-blind Treatment Period|"A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura.~The change from baseline in monthly migraine days was calculated as the average number of migraine days per month during the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase - the number of migraine days during the 4-week baseline phase."|4-week baseline phase and the last 3 months (months 4, 5, and 6) of the 24-week double-blind treatment phase|The analysis was conducted in the efficacy analysis set which includes participants who received at least 1 dose of study drug and had at least 1 change from baseline measurement in monthly migraine days in the double-blind treatment phase.|||migraine days / month||Standard Error|Least Squares Mean
2576003|NCT02456662|Primary|Number of Participants Experiencing Symptoms|Number of participants experiencing symptoms (vomiting or nausea+vomiting) at the time of or after doxycycline|24 hours|This was an intent to treat analysis so all participants were included.|||Participants|||Count of Participants
2576016|NCT02455388|Secondary|Change in d13C: delta13C Added Sugar Biomarker|Validity, reliability and sensitivity of the fingerstick blood delta13C AS biomarker during feeding study. Participants are provided 7 days of food with high or low added sugar diet. Blood samples will be obtained each day via fingerstick to analyze delta13C biomarker levels.|Two 7-day feeding periods, randomized order, with a four-week washout between feeding periods. Outcome is a change in d13C from day 1 to 8, for each feeding period.|Adolescents aged 12-18 years with a body mass index percentile <95%. They were willing to follow a controlled diet and did not have food allergies, intolerances or aversions.|||‰||Standard Deviation|Mean
2576004|NCT02456103|Secondary|Rate of Pulmonary Exacerbations as Defined by Modified Fuch's Criteria Over 48 Weeks|A modified Fuchs' exacerbation was defined as an event requiring treatment with or without intravenous antibiotics for any 4 of the following 12 symptoms: change in sputum; new or increased hemoptysis; increased cough; increased dyspnea; fatigue; temperature >38°C; anorexia; sinus pain; change in sinus discharge; change in physical examination of the chest; decrease in pulmonary function by 10 percent or more from a previously recorded value; or radiographic changes indicative of pulmonary function. The 48-week rate = (the total number of events/ treatment duration by week)*48.|Baseline up to Week 48|Participants who received at least 1 dose of ataluren and have at least 1 postbaseline efficacy assessment (ITT Population).|||exacerbations||Standard Deviation|Mean
2576005|NCT02456103|Secondary|Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Expiration (FEF25-75) as Measured by Spirometry at Week 24|Pulmonary function of FEF25-75 was measured using a spirometer. FEF25-75 is the forced expiratory flow between 25% and 75% of vital capacity. Each percent-predicted FEF25-75 was based gender, age, and the height value obtained at the same study visit. The percentage of change in percent-predicted of FEF25-75 was calculated as follows: (percent-predicted FEF25-75 - Baseline percent-predicted FEF25-75/Baseline percent-predicted FEF25-75)*100.|Baseline, Week 24|Participants who received at least 1 dose of ataluren and have at least 1 postbaseline efficacy assessment (ITT Population) and had evaluable FEF25-75 data.|||percentage of FEF25-75||Standard Deviation|Mean
2576006|NCT02456103|Secondary|Change From Baseline in Percent-Predicted of Forced Vital Capacity (FVC) as Measured by Spirometry at Week 24|Pulmonary function of FVC was measured using a spirometer. FVC is the volume of air that can forcibly be blown out. Each percent-predicted FVC was based gender, age, and the height value obtained at the same study visit. The percentage of change in percent-predicted of FVC was calculated as follows: (percent-predicted FVC - Baseline percent-predicted FVC/Baseline percent-predicted FVC)*100.|Baseline, Week 24|Participants who received at least 1 dose of ataluren and have at least 1 postbaseline efficacy assessment (ITT Population) and had evaluable FVC data.|||percentage of predicted FVC||Standard Deviation|Mean
2576007|NCT02456103|Secondary|Change From Baseline in Percent-Predicted Forced Expiratory Volume in 1 Second (FEV1) as Measured by Spirometry at Week 24|Pulmonary function of percent-predicted FEV1 was measured using a spirometer. FEV1 is the volume of air that can forcibly be blown out in 1 second. Each percent-predicted FEV1 was based gender, age, and the height value obtained at the same study visit. The percentage of change in percent-predicted of FEV1 was calculated as follows: (percent-predicted FEV1 - Baseline percent-predicted FEV1/Baseline percent-predicted FEV1)*100.|Baseline, Week 24|Participants who received at least 1 dose of ataluren and have at least 1 postbaseline efficacy assessment (ITT Population) and had evaluable FEV1 data.|||percentage of predicted FEV1||Standard Deviation|Mean
2576008|NCT02456103|Primary|Number of Participants With a Clinically Meaningful Abnormal Clinical Laboratory (Serum Biochemistry, Hematology, and Urinalysis) Parameter|Clinical laboratory results considered clinically meaningful were determined by Investigator. Serum biochemistry parameters: sodium, potassium, chloride, bicarbonate, blood urea nitrogen, creatinine, magnesium, calcium, phosphorus, uric acid, glucose, total protein, albumin, globulin, bilirubin, creatine kinase, lactate dehydrogenase, alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, alkaline phosphatase, total cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides, and cystatin C. Hematology parameters: white blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, red cell count with morphology, and platelet count. Urinalysis parameters: pH, specific gravity, glucose, ketones, blood, protein, creatinine, urobilinogen, bilirubin, nitrite, and leukocyte esterase. A summary of all SAEs/nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline up to Week 100|Participants who received at least 1 dose of ataluren (As-Treated Population).|||Participants|||Count of Participants
2576009|NCT02456103|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|TEAE: any untoward medical occurrence or undesirable event that begins or worsens following administration of study drug, whether or not considered related to study drug by Investigator. Serious adverse event (SAE): an adverse event (AE) resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying) or persistent or significant disability/incapacity. Except for cystic fibrosis (CF) pulmonary exacerbations, an event wasn't reported as an SAE, if event was exclusively a relapse or an expected change or progression of baseline CF. AEs included both SAEs and nonserious AEs. AEs classified according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 and coded using Medical Dictionary for Regulatory Activities. A summary of SAEs and all nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline up to Week 100|Participants who received at least 1 dose of ataluren (As-Treated Population).|||Participants|||Count of Participants
2576010|NCT02455518|Secondary|Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores|Change in numerical rating scale (NRS) pre and 1-hour post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)|1 hour||||units on a scale||95% Confidence Interval|Number
2576011|NCT02455518|Primary|Between Group Difference in Change in Numerical Rating Scale (NRS) Pain Scores|Change in numerical rating scale (NRS) pre and 2 hours post receiving study medication while in the ED. The NRS is a validated 11-point numerical scale that ranges from 0 (no pain) to 10 (worst pain possible)|2 hours||||units on a scale||95% Confidence Interval|Number
2576012|NCT02455453|Secondary|Heterogeneity of Tumor FFNP Uptake as Measured by Number of Participants With Heterogenous Response|As measured visually in known lesion by recording presence or absence of uptake with note of any changes between scans|Completion of second FFNP-PET/CT scan (up to 4 weeks)|2 participants were not included in this outcome measure as the liver background was too high in both participants.|||Participants|||Count of Participants
2576013|NCT02455453|Primary|Change in Secondary Tumor FFNP Uptake Before and After Estradiol Challenge as Measured by Percent Change in Standardized Uptake Value (SUV)||Completion of second FFNP-PET/CT scan (up to 4 weeks)|12 participants were not included in this outcome measure as they did not have a secondary tumor location and 2 participants were not included in this outcome measure as the liver background was too high in both participants.|||percent change in SUV||Full Range|Median
2579897|NCT02412501|Secondary|Number of Participants With a Major Adverse Cardiac Event at 24 Months Post Procedure||24 Months||||Participants|||Count of Participants
2576017|NCT02455388|Primary|delta13C Added Sugar Biomarker|Validity, reliability, and sensitivity of the fingerstick blood d13C AS biomarker during cross-sectional data collection. Participants will provide 4 separate self-reported, record-assisted 24-hr food intake recalls, and at two of the visits, a fingerstick blood sample will be collected to analyze delta13C biomarker levels.|2-3 weeks||||‰ δ13C||Standard Deviation|Mean
2576018|NCT02455336|Other Pre-specified|Adverse Event Profile|Documentation and description of adverse events will be obtained in subjects who have received drug treatment compared to events occurring in the control group.|4 months||||Participants|||Count of Participants
2576019|NCT02455336|Secondary|Triglyceride Concentration (Percent Change From Baseline)|To determine the efficacy of fenofibrate monotherapy to lower TG concentration at 4 months of treatment, when the peak therapeutic efficacy to drug treatment has been reported to occur.|four months from initiating drug treatment||||percent change from baseline||Standard Deviation|Mean
2576020|NCT02455336|Primary|Triglyceride Concentration (Percent Change From Baseline)|To determine the efficacy of fenofibrate monotherapy after 2 months of treatment to improve the lipoprotein profile; a successful response will be defined as a 25% reduction in the serum TG concentration at 2 months.|two months from initiating drug treatment||||percent change from baseline||Standard Deviation|Mean
2576021|NCT02455076|Secondary|Change in Diastolic Blood Pressure|Change in Diastolic Blood Pressure from the time of discharge to 12 weeks after discharge will be recorded|Discharge (after day 10 or hospital stay), 12 weeks after discharge||||mmHg||Standard Deviation|Mean
2576022|NCT02455076|Secondary|Efficacy, Measured by HbA1c Levels and no Hypoglycemia|Number of patients who have an HbA1c <7.0% and no hypoglycemia at 12 weeks from discharge will be recorded.|12 weeks from discharge.||||Participants|||Count of Participants
2576023|NCT02455076|Secondary|Efficacy, Measured by HbA1c Levels and no Weight Gain|Number of patients who have an HbA1c <7.0% and no weight gain at 12 weeks from discharge will be recorded.|12 weeks from discharge.||||Participants|||Count of Participants
2576024|NCT02455076|Secondary|Change in Heart Rate|Change in heart rate from the time of discharge to 12 weeks after discharge will be recorded|Discharge (after day 10 or hospital stay), 12 weeks after discharge||||heart beats/min||Standard Deviation|Mean
2576025|NCT02455076|Secondary|Change in Systolic Blood Pressure|Change in Systolic Blood Pressure from the time of discharge to 12 weeks after discharge will be recorded|Discharge (after day 10 or hospital stay), 12 weeks after discharge||||mmHg||Standard Deviation|Mean
2576026|NCT02455076|Secondary|Number of Severe Gastrointestinal Adverse Events|Number of Severe (require hospitalization) Gastrointestinal Adverse Events|12 weeks from discharge.||||number of events|||Number
2576027|NCT02455076|Secondary|Number of Acute Kidney Injury Events|Number of Acute Kidney Injury events will be recorded|12 weeks from discharge.||||number of events|||Number
2576028|NCT02455076|Secondary|Number of Hospital Readmissions|Number of hospital readmissions during 12 weeks after discharge will be recorded|12 weeks after discharge||||number of readmissions|||Number
2576029|NCT02455076|Secondary|Number of Patients Who Had Emergency Room Visits|The number of patients who had emergency room visits from the time of discharge to 12 weeks after discharge will be recorded.|12 weeks after discharge||||participants|||Number
2576030|NCT02455076|Secondary|Change in Body Mass Index|The change in BMI from discharge to 12 weeks after discharge will be calculated|Discharge (after day 10 or hospital stay), 12 weeks after discharge 12 weeks after discharge||||kg/m2||Standard Deviation|Mean
2576031|NCT02455076|Secondary|Change in Body Weight|The change in Body Weight from discharge to 12 weeks after discharge will be recorded|Time of discharge, 12 weeks after discharge||||pounds||Standard Deviation|Mean
2576032|NCT02455076|Secondary|Number of Patients With Severe Hypoglycemic Events|Occurrences of hypoglycemia (blood glucose levels < 40 mg/dL) will be detected by blood test|12 weeks after discharge||||Participants|||Count of Participants
2576033|NCT02455076|Secondary|The Number of Patients With Hypoglycemia Outpatient|Occurrence of hypoglycemia (blood glucose levels < 70 mg) will be identified by blood test|12 weeks after discharge||||Participants|||Count of Participants
2576034|NCT02455076|Secondary|Mean Daily Blood Glucose Concentration During Outpatient Period|Mean Daily Blood Glucose Concentration will be calculated and recorded.|12 weeks after discharge||||mg/dL||Standard Deviation|Mean
2576035|NCT02455076|Secondary|Mean Fasting Blood Glucose Levels During Outpatient Period|Fasting Blood Glucose Levels were measured using blood test|12 weeks after discharge||||mg/dL||Standard Deviation|Mean
2576036|NCT02455076|Secondary|Incidence of Hospital Readmissions|The number of patients who require readmission to the hospital from the time of discharge to 12 weeks after discharge will be recorded.|12 weeks after discharge||||Participants|||Count of Participants
2576037|NCT02455076|Secondary|Number of Patients With Severe Hypoglycemic Events Inpatient|Occurrences of hypoglycemia (blood glucose levels < 40 mg/dL) will be recorded.|Duration of hospital stay, an expected average of 10 days||||Participants|||Count of Participants
2576038|NCT02455076|Secondary|Incidence of Gastrointestinal Adverse Events Inpatient|The number of subjects who experience gastrointestinal side effects including nausea, vomiting and diarrhea will be recorded.|Duration of hospital stay, an expected average of 10 days||||Participants|||Count of Participants
2576039|NCT02455076|Secondary|Incidence of Acute Kidney Injury Inpatient|The number of patients who experience acute kidney injury diagnosed by an increment in serum creatinine >0.5 mg/dL from admission value or 50% of baseline value will be recorded.|Duration of hospital stay, an expected average of 10 days||||Participants|||Count of Participants
2576040|NCT02455076|Secondary|Hospital Complications|The total number of subjects who experience hospital complications like nosocomial pneumonia, bacteremia, respiratory failure, acute renal failure, and wound infections (surgery patients) will be recorded. Nosocomial infections will be diagnosed based on standardized Centers for Disease Control (CDC) criteria.|Duration of hospital stay, an expected average of 10 days||||Participants|||Count of Participants
2576041|NCT02455076|Secondary|Hospital Mortality|The total number of subject deaths during hospital stay will be recorded.|Duration of hospital stay, an expected average of 10 days||||Participants|||Count of Participants
2576042|NCT02455076|Secondary|Incidence of the Need for ICU Care Inpatient|The total number of patients who require transfer to the ICU will be recorded.|Duration of hospital stay, an expected average of 10 days||||Participants|||Count of Participants
2576046|NCT02455076|Secondary|Incidence of Hypoglycemic Events Inpatient|The number of patients with hypoglycemia (blood glucose levels < 70 mg/dL) will be recorded.|Duration of hospital stay, an expected average of 10 days||||Participants|||Count of Participants
2576047|NCT02455076|Secondary|Mean Premeal Blood Glucose Levels Inpatient|The blood glucose levels prior to each meal will using a glucose meter.|Duration of hospital stay, an expected average of 10 days||||mg/dL||Standard Deviation|Mean
2576048|NCT02455076|Secondary|Mean Fasting Blood Glucose Levels Inpatient|The blood glucose levels prior to the patient's first meal of the day will be assessed using a glucose meter.|Duration of hospital stay, an expected average of 10 days.||||mg/dL||Standard Deviation|Mean
2576049|NCT02455076|Primary|Change in HbA1c Concentration Inpatient|The difference in the levels of HbA1c at discharge and at 12 weeks from discharge will be measured. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent.|12 weeks from discharge.||||percentage of HbA1c||Standard Deviation|Mean
2576050|NCT02455076|Primary|Mean Daily Blood Glucose Concentration Inpatient|The levels of blood glucose (BG) will be measured before each meal and at bedtime using a glucose meter. Blood glucose will be measured at baseline and during the hospital stay (up to 10 days).|Duration of hospital stay, an expected average of 10 days.||||mg/dL||Standard Deviation|Mean
2576051|NCT02455050|Secondary|Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 2|Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable.|After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.|||score on a scale||Standard Deviation|Mean
2576052|NCT02455050|Secondary|Eye Drop Experience Survey Score: Assessing Vision, Comfort, and Relief of Symptoms in Period 1|Participants completed the 4 question Eye Drop Experience Survey at 5 and 30 minutes post drop instillation: Question (Q) 1-vision clear/without blur, Q2-drops soothing/comfortable, Q3-drops relieve dry eye symptoms and Q4-comfortable/soothing. Q1 to Q3 were answered using a 5-point scale: 1=strongly disagree to 5=strongly agree. Q4 is answered using a Labeled Hedonic scale by placing a mark on a vertical line where the bottom of the line -100=most uncomfortable/irritating imaginable, middle of the line=neutral to top of the line 100=most comfortable/soothing imaginable.|After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.|||score on a scale||Standard Deviation|Mean
2576053|NCT02455050|Secondary|Tear Break-Up Time With Fluorescein in Period 2|Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.|After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.|||seconds||Standard Deviation|Mean
2576054|NCT02455050|Secondary|Tear Break-Up Time With Fluorescein in Period 1|Fluorescein was applied to the eyes and three consecutive TBUTs are performed in each eye at 5 and 30 minutes post drop instillation. TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film.|After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.|||seconds||Standard Deviation|Mean
2576055|NCT02455050|Secondary|Distance Visual Acuity in Period 2|Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters).|After 14 days of treatment in Period 2 (Follow-up 2 Day 35), 5 and 30 minutes post drop instillation|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.|||Letters Read Correctly||Standard Deviation|Mean
2576056|NCT02455050|Secondary|Distance Visual Acuity in Period 1|Distance visual acuity is measured in each eye at 5 and 30 minutes post drop instillation using an eye chart at 4 meters and is reported as the number of letters read correctly (ranging from 0 to 100 letters).|After 14 days of treatment in Period 1 (Follow-up 1 Day 14), 5 and 30 minutes post drop instillation|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.|||Letters Read Correctly||Standard Deviation|Mean
2576057|NCT02455050|Secondary|Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Genteal®)|End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported.|Day 35|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. Data is missing for 6 participants.|||percentage of participants|||Number
2576108|NCT02454478|Secondary|Css,Max: Maximum Observed Plasma Concentration at Steady State for Levatinib and Everolimus||Cycle 1 Day 15 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)|The PK analysis was group of participants who received at least 1 dose of lenvatinib and had sufficient data from which at least one PK parameter could be calculated. The PK analysis set where data at specified time points was available.|||ng/mL||Standard Deviation|Mean
2576058|NCT02455050|Secondary|Percentage of Participants by Response in End of Study Survey: Assessing Comfort, Blur, and Relief of Symptoms (New Eye Drop Formulation Versus Systane®)|End of Study Survey consisted of 4 questions assessing product preference: Q1-overall comfort, Q2-symptom relief, Q3-less blurring and Q4-preference/willingness to purchase the product. The participant answered each questions using the scale: a=first product better, b=second product better or c=equal. The percentage of participants in each response category is reported.|Day 35|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. Data is missing for 3 participants.|||percentage of participants|||Number
2576059|NCT02455050|Secondary|Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 2|SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities).|Baseline and After 14 days of treatment in Period 2 (Follow-up 2 Day 35)|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.|||score on a scale||Standard Deviation|Mean
2576060|NCT02455050|Secondary|Subjective Evaluation of Symptoms of Dryness (SESoD) Score Using a 5-Point Scale in Period 1|SESoD assessed the severity of dryness (defined as discomfort/irritation due to dry feeling in the eye) evaluated by the participant on a 5-point scale: 0=none, 1=trace, 2=mild, 3=moderate and 4=severe (always notice the symptom and interferes with activities).|Baseline and After 14 days of treatment in Period 1 (Follow-up 1 Day 14)|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.|||score on a scale||Standard Deviation|Mean
2576061|NCT02455050|Secondary|Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 2|Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported.|After 14 days of treatment in Period 2 (Follow-up 2 Day 35)|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.|||percentage of participants|||Number
2576062|NCT02455050|Secondary|Percentage of Participants Selecting Strongly Agree or Agree in the Acceptability Survey Score Using a 5-Point Scale in Period 1|Acceptability Survey is comprised of 8 questions (Q): Q1-effective dry-eye relief, Q2-eyes feel comfortable, Q3-vision did not blur, Q4-vision normal within 10 minutes, Q5-substantial feel/optimally thick, Q6-eyelashes not matted/crusty, Q7- satisfied overall and Q8-switch to this product/if my doctor recommended. The participant answered the questions using the following scale: a=strongly agree, b=agree, c=neither agree nor disagree, d=disagree and e=strongly disagree. The percentage of participants who selected Strongly Agree or Agree is reported.|After 14 days of treatment in Period 1 (Follow-up 1 Day 14)|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.|||percentage of participants|||Number
2576063|NCT02455050|Secondary|Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 2|The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst.|Baseline and after 14 days of treatment in Period 2 (Follow-up 2 Day 35)|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.|||score on a scale||Standard Deviation|Mean
2576064|NCT02455050|Secondary|Ocular Surface Disease Index© (OSDI©) Score Using a 5-Point Scale in Period 1|The OSDI Questionnaire consisted of 12 questions: ocular symptoms (sensitive to light, feel gritty, painful or sore), vision-related functions (blurred vision, poor vision, reading, driving at night, working on a computer and watching TV) and environmental triggers (windy conditions, low humidity/dry areas and air-conditioned areas). Participants were asked to base their evaluation on the frequency of their symptoms over the last week, using a 5-point scale: 0=none of the time to 4=all of time. The total score is converted to a 0 to 100 score where 0 is best and 100 is worst.|Baseline and after 14 days of treatment in Period 1 (Follow-up 1 Day 14)|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit.|||score on a scale||Standard Deviation|Mean
2576065|NCT02455050|Primary|Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 2|Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).|After 14 days of treatment in Period 2 (Follow-up 2 Day 35)|Participants from the Primary Efficacy Population, all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit and participated in Period 2.|||score on a scale||Standard Deviation|Mean
2576130|NCT02454101|Secondary|Neonatal Intensive Care Unit (NICU) Admission|number of Neonatal Intensive Care unit (NICU) admission in the 1st 24 hours after delivery|1st 24 hours after delivery|Number of Infants Analyzed|||participants|||Number
2576066|NCT02455050|Primary|Tolerability Survey Score Using a 100 Unit Visual Analog Scale (VAS) in Period 1|Tolerability was assessed using an 8-item survey consisting of 4 positive questions: comfort, soothing, moistening/lubricating and vision clarity and 4 negative questions: stickiness, blur, burning/stinging and discomfort. Participants were instructed to think about their experience over the past week and place a vertical line on the line that best captured how they felt the first 30 minutes after the study drops were administered using the scale: 0 far left of the line to 100 far right on the line. The individual positive scores are added together to obtain the total positive tolerability score from 0 (worst) to 400 (best) and the individual negative scores are added together to obtain the total negative tolerability score for a total possible score of 0 (best) to 400 (worst).|After 14 days of treatment in Period 1 (Follow-up 1 Day 14)|Primary Efficacy Population consisted of all enrolled participants who did not have any significant protocol deviations and completed at least 1 follow-up visit. Participants enrolled in Period 1.|||score on a scale||Standard Deviation|Mean
2576067|NCT02454959|Secondary|Tmax on Day 8|Pharmacokinetic Parameter tmax of Formoterol by Treatment on Day 8|Day 8|Pharmacokinetic Population|||h||Full Range|Median
2576068|NCT02454959|Secondary|Tmax on Day 8|Pharmacokinetic Parameter tmax of Glycopyrronium by Treatment on Day 8|Day 8|Pharmacokinetic Population|||h||Full Range|Median
2576069|NCT02454959|Secondary|Cmax on Day 8|Pharmacokinetic Parameter Cmax of Formoterol by Treatment on Day 8|Day 8|Pharmacokinetic Population|||pg/mL||Standard Deviation|Mean
2576070|NCT02454959|Secondary|Cmax on Day 8|Pharmacokinetic Parameter Cmax of Glycopyrronium by Treatment on Day 8|Day 8|Pharmacokinetic Population|||pg/mL||Standard Deviation|Mean
2576071|NCT02454959|Secondary|AUC0-12 on Day 8|Pharmacokinetic Parameter AUC0-12 of Formoterol by Treatment on Day 8|Day 8|Pharmacokinetic Population|||h*pg/mL||Standard Deviation|Mean
2576072|NCT02454959|Secondary|AUC0-12 on Day 8|Pharmacokinetic Parameter AUC0-12 of Glycopyrronium by Treatment on Day 8|Day 8|Pharmacokinetic Population|||h*pg/mL||Standard Deviation|Mean
2576073|NCT02454959|Primary|Area Under the Curve for Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) From 0 to 12 Hours (AUC0-12) on Day 8|AUC0-12 was calculated using the trapezoidal rule based on FEV1 assessments at pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours post-dosing of study drug. Primary Outcome was calculated using the trapezoidal rule and was modeled conditionally on baseline FEV1.|7 days of treatment|The primary analysis used the Modified-Intent-to-Treat (MITT) Population.|||Liter||Standard Error|Least Squares Mean
2576074|NCT02454933|Primary|Number of Subjects With Adverse Events (AEs) as a Measure of the Safety and Tolerability of Osimertinib in Combination With Durvalumab|As a measure of the safety and tolerability of osimertinib in combination with durvalumab the number of subjects who experienced any treatment emergent AE (TEAE), any causally related AE, any serious AE (SAE), and any causally related SAE are presented.|From Baseline up to 3 months after the last dose (up to 24 months).|The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.|||Participants|||Count of Participants
2576075|NCT02454608|Primary|Subjective Sinonasal Symptoms on 10cm Visual Analogue Scale(VAS)|Minimum Score: 0 Maximum Score: 100 A higher score indicates a worse outcome.|baseline to week 56|Intention-to-treat analysis|||units on a scale||Standard Error|Mean
2576076|NCT02454608|Primary|Subjective Sinonasal Symptoms on Sinonasal Outcomes Test-22(SNOT-22)|Minimum Score: 0 Maximum Score: 110 A higher score indicates a worse outcome|baseline to week 56|Intention-to-treat analysis|||units on a scale||Standard Error|Mean
2576077|NCT02454608|Other Pre-specified|Diastolic Blood Pressure||Mean change between baseline and week 8 measurements||||mmHg||Standard Deviation|Mean
2576078|NCT02454608|Other Pre-specified|Systolic Blood Pressure||Mean change between baseline and week 8 measurements||||mmHg||Standard Deviation|Mean
2576079|NCT02454608|Other Pre-specified|Heart Rate||Mean change between baseline and week 8 measurements.||||beats per minute||Standard Deviation|Mean
2576080|NCT02454608|Secondary|Objective Sinonasal Symptoms on Lund-McKay Score(LMS)|Minimum Score: 0 Maximum Score: 24 Higher value represents worse outcome.|Week 8|Intention-to-treat analysis|||units on a scale||Standard Deviation|Mean
2576081|NCT02454608|Secondary|Objective Sinonasal Symptoms on Lund-Kennedy Score(LKS)|Minimum Score: 0 Maximum Score: 12 Higher value represents worse outcome.|baseline to week 8|Intention-to-treat analysis|||units on a scale||Standard Error|Least Squares Mean
2576082|NCT02454608|Primary|Subjective Sinonasal Symptoms on 10cm Visual Analogue Scale(VAS)|Minimum Score: 0 Maximum Score: 100 A higher score indicates a worse outcome.|baseline to week 8|Intention-to-treat analysis|||units on a scale||Standard Error|Least Squares Mean
2576083|NCT02454608|Primary|Subjective Sinonasal Symptoms on Sinonasal Outcomes Test-22(SNOT-22)|Minimum Score: 0 Maximum Score: 110 A higher score indicates a worse outcome|baseline to week 8|Intention-to-treat analysis|||units on a scale||Standard Error|Least Squares Mean
2576084|NCT02454530|Other Pre-specified|Number of Participants in Different Profiles Receiving Treatment With Nivestim|Classification of participants into three different profiles were established by level of importance of the determining factors for the use of Nivestim and was categorized as profile 1= not applicable, profile 2= relatively unimportant and profile 3 = not important. A multiple correspondence analysis was conducted on the whole analysis population in order to identify possible different patient profiles. None of these profiles could have been associated to a type of chemotherapy (adjuvant or metastatic).|End of study visit (up to Week 19)|Analysis population included all participants who received at least one dose of Nivestim and did not had a major deviation from the protocol and who did not had any missing importance level for the determining factors for the use of Nivestim. Here, “Overall Number of Participants Analyzed”=number of participants evaluable for this outcome measure.|||Participants|||Count of Participants
2576094|NCT02454530|Secondary|Number of Participants With Unplanned Discontinuation of Chemotherapy at the End of Study Visit|The reasons for unplanned discontinuation of chemotherapy included neutropenia, febrile neutropenia, other toxicity, development of resistance to treatment and other. Also, one participant could have more than one reason for unplanned discontinuation.|End of study visit (up to Week 19)|Analysis population included all participants who received at least one dose of Nivestim and did not had a major deviation from the protocol. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure.|||Participants|||Count of Participants
2576085|NCT02454530|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment Emergent Adverse Event (TEAE) was adverse event that started or worsened in severity after Inclusion visit up to end of study visit (up to Week 19). AEs included both serious and non-serious adverse event. If a participant who reported an SAE also reported an AE that was not serious, that would count as 1 participant in the total number of participants reporting AEs.|Inclusion visit (Week 1) up to end of study visit (up to Week 19)|The safety population included all participants who received at least one dose of Nivestim during the study.|||Participants|||Count of Participants
2576086|NCT02454530|Secondary|Number of Participants Who Wished to Again Have Nivestim Treatment If Necessary||End of study visit (up to Week 19)|Analysis population included all participants who received at least one dose of Nivestim and did not have a major deviation from the protocol. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure.|||Participants|||Count of Participants
2576087|NCT02454530|Secondary|Number of Participants With Chemotherapy Satisfaction as Per Doctor Assessment After Chemotherapy Treatment|Participant's satisfaction after the chemotherapy treatment was assessed by the doctor and was categorized under the 4 categories as very satisfied, satisfied, not very satisfied and dissatisfied.|End of study visit (up to Week 19)|Analysis population included all participants who received at least one dose of Nivestim and did not had a major deviation from the protocol. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure.|||Participants|||Count of Participants
2576088|NCT02454530|Secondary|Pain Experienced by Participant During Injection of Nivestim as Assessed by Pain at the Injection Site|Pain experienced by participant at the injection site was measured on a scale 0 to 10 (0 = no pain to 10 = maximum pain), where higher score indicates maximum pain.|End of study visit (up to Week 19)|Analysis population included all participants who received at least one dose of Nivestim and did not had a major deviation from the protocol. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure.|||unit on a scale||Standard Deviation|Mean
2576089|NCT02454530|Secondary|Change From Inclusion Visit in Disease Status as Measured by Haemoglobin Level at End of Study Visit|Change in the disease status of the participant was measured by the change in the hemoglobin level as reported in this outcome measure.|Inclusion visit (Week 1), End of study visit (up to Week 19)|Analysis population included all participants who received at least one dose of Nivestim and did not had a major deviation from the protocol. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure.|||grams per deciliter (g/dl)||Standard Deviation|Mean
2576090|NCT02454530|Secondary|Change From Inclusion Visit in Disease Status as Measured by Participants Performance Status at End of Study|The Karnofsky performance scale was used for rating participant activities of daily living. The KPS scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities. The lower the Karnofsky score, the worse the survival for most serious illnesses. The score ranges included as 100 (Normal; no complaints), 90 (Able to carry on normal activity), 80 (Normal activity with effort), 70 (Cares for self; unable to carry on normal activity), 60 (Requires occasional assistance, but is able to care), 50 (Requires considerable assistance and frequent medical care), 40 (Disabled; requires special care), 30 (Severely disabled), 20 (Very sick; hospital admission necessary), 10 (Moribund; fatal processes progressing rapidly) and 0 (Dead).|Inclusion visit (Week 1); End of study visit (up to Week 19)|Analysis population included all participants who received at least one dose of Nivestim and did not had a major deviation from the protocol. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure.|||score on a scale||Standard Deviation|Mean
2576091|NCT02454530|Secondary|Change From Inclusion Visit in Disease Status as Measured by Number of Neutrophil Cells (Neutrophils), Platelet Count and Leukocyte Count at End of Study|Change in the disease status of the participant was measured by the change in the count of neutrophils (NPs), platelets and leukocytes as reported in this outcome measure.|Inclusion visit (Week 1), End of study visit (up to Week 19)|Analysis population included all participants who received at least one dose of Nivestim and did not had a major deviation from the protocol. Here 'Number analyzed' signifies number of participants evaluable for specified categories.|||gram per liter (g/L)||Standard Deviation|Mean
2576092|NCT02454530|Secondary|Number of Participants With Neutropenia and Febrile Neutropenia|Neutropenia is an abnormally low level of neutrophils (count of less than 1,500 neutrophils per microL in blood) and was classified as Grade 1 (mild) with an ANC of 1000-1500 cells per microL, Grade 2 (moderate) with an ANC of 500-1000 cells per microL, or Grade 3 (severe) with an ANC lower than 500 cells per microL. The incidence of neutropenia (between follow up and final visit) were described from the questionnaire completed by the investigator during the final visit. Febrile neutropenia was defined as tympanic or axillary body temperature greater than (>) 38.5 degree celsius for >1 hour and ANC less than (<) 1.0 *10^9 neutrophils per liter. The incidence of febrile neutropenia were described from the questionnaire completed by the investigator during the follow-up and final visits. Only those categories which had atleast 1 abnormality have been reported in this outcome measure.|Follow-up visit (Week 3); End of study visit (up to Week 19)|Analysis population included all participants who received at least one dose of Nivestim and did not had a major deviation from the protocol. Here 'Number analyzed' signifies number of participants evaluable for specified categories.|||Participants|||Count of Participants
2576093|NCT02454530|Secondary|Number of Participants With Change in Chemotherapy Protocol at End of Study Visit|Number of participants with change in chemotherapy protocol due to each conditions (neutropenia, febrile neutropenia, neutropenia/febrile neutropenia, other toxicity, neutropenia/other toxicity) has been reported in this outcome measure.|End of study visit (up to Week 19)|Analysis population included all participants who received at least one dose of Nivestim and did not had a major deviation from the protocol. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure.|||Participants|||Count of Participants
2576095|NCT02454530|Secondary|Number of Participants With Delayed Administration of Chemotherapy Cycle Due to Neutropenia|Neutropenia is an abnormally low level of neutrophils (count of less than 1,500 neutrophils per microliter (microL) in blood) and was classified as Grade 1 (mild) with an absolute neutrophil count (ANC) of 1000-1500 cells per microL, Grade 2 (moderate) with an ANC of 500-1000 cells per microL, or Grade 3 (severe) with an ANC lower than 500 cells per microL.|Follow-up visit (Week 3)|Analysis population included all participants who received at least one dose of Nivestim and did not had a major deviation from the protocol. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure.|||Participants|||Count of Participants
2576096|NCT02454530|Secondary|Number of Participants With Dose Reduction in Chemotherapy Due to Neutropenia|Neutropenia is an abnormally low level of neutrophils (count of less than 1,500 neutrophils per microliter (microL) in blood) and was classified as Grade 1 (mild) with an absolute neutrophil count (ANC) of 1000-1500 cells per microL, Grade 2 (moderate) with an ANC of 500-1000 cells per microL, or Grade 3 (severe) with an ANC lower than 500 cells per microL.|Follow-up visit (Week 3)|Analysis population included all participants who received at least one dose of Nivestim and did not had a major deviation from the protocol. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure.|||Participants|||Count of Participants
2576097|NCT02454530|Secondary|Number of Participants With Unplanned Discontinuation of Chemotherapy at Follow Up Visit||Follow-up visit (Week 3)|Analysis population included all participants who received at least one dose of Nivestim and did not had a major deviation from the protocol. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for the specified outcome measure.|||Participants|||Count of Participants
2576098|NCT02454530|Secondary|Number of Participants Who Discontinued Chemotherapy||Follow-up visit (Week 3); End of study visit ( up to Week 19)|Analysis population included all participants who received at least one dose of Nivestim and did not had a major deviation from the protocol. Here 'Number analyzed' signifies number of participants evaluable for specified categories.|||Participants|||Count of Participants
2576099|NCT02454530|Secondary|Number of Participants Who Continued Chemotherapy|Chemotherapy is a type of cancer treatment that uses one or more anti-cancer drugs as a part of a standardize treatment regimen. Chemotherapy may be given with curative intent, or it may aim to prolong life or to reduce symptoms.|Follow-up visit (Week 3); End of study visit ( up to Week 19)|Analysis population included all participants who received at least one dose of Nivestim and did not had a major deviation from the protocol. Here, 'Number analyzed' signifies number of participants evaluable for specified categories.|||Participants|||Count of Participants
2576100|NCT02454530|Primary|Percentage of Participants by Level of Importance of Factors Determining the Use of Nivestim|The factors which determined the use of Nivestim among participants included participant's sex, young participant, elderly participant, past history of infection, comorbidities, life expectancy, past history of febrile neutropenia and severe neutropenia, occupational activity, family activity and other important criteria. Percentage of participants were categorized based upon the level of importance under different categories which included very important, important, relatively important, not important and not applicable.|Inclusion visit (Week 1)|Analysis population included all participants who received at least one dose of Nivestim and did not had a major deviation from the protocol. Here 'Number analyzed' signifies number of participants evaluable for specified categories.|||Percentage of participants|||Number
2576101|NCT02454478|Secondary|Number of Participants With the Minimum Percent Change From Baseline in the Sum of Diameters of Target Lesions||Baseline up to first tumor assessment at which diameter of target lesions were available (up to approximately 23 months)|The efficacy analysis set was the group of participants who received at least 1 dose of lenvatinib.|||participants|||Number
2576102|NCT02454478|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of participants who achieved BOR of CR, PR, or SD. DCR was assessed based on RECIST 1.1.|From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 23 months)|The efficacy analysis set was the group of participants who received at least 1 dose of lenvatinib.|||percentage of participants|||Number
2576103|NCT02454478|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants who achieved BOR of CR or PR. ORR was assessed using RECIST 1.1.|From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 23 months)|The efficacy analysis set was the group of participants who received at least 1 dose of lenvatinib.|||percentage of participants|||Number
2576104|NCT02454478|Secondary|Number of Participants With Best Overall Response (BOR)|BOR included complete response (CR), partial response (PR), stable disease (SD), and PD (progressive disease). BOR was assessed using Response Evaluation Criteria in Solid Tumor (RECIST) 1.1|From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 23 months)|The efficacy analysis set was the group of participants who received at least 1 dose of lenvatinib.|||participants|||Number
2576105|NCT02454478|Secondary|AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Levatinib and Everolimus||Cycle 1 Day 1 and Cycle 1 Day 15 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)|The PK analysis set was group of participants who received at least 1 dose of lenvatinib and had sufficient data from which at least one PK parameter could be calculated. The PK analysis set where data at specified time points was available.|||hour * nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
2576106|NCT02454478|Secondary|Tss,Max: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for Levatinib and Everolimus||Cycle 1 Day 15 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)|The PK analysis was group of participants who received at least 1 dose of lenvatinib and had sufficient data from which at least one PK parameter could be calculated. The PK analysis set where data at specified time points was available.|||hour||Full Range|Median
2576107|NCT02454478|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Levatinib and Everolimus||Cycle 1 Day 1 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)|The PK analysis was group of participants who received at least 1 dose of lenvatinib and had sufficient data from which at least one PK parameter could be calculated.|||hour||Full Range|Median
2576109|NCT02454478|Secondary|Cmax: Maximum Observed Plasma Concentration for Levatinib and Everolimus||Cycle 1 Day 1 predose and at 1, 2, 4 ,8, and 24 hours postdose (Cycle length=28 days)|The pharmacokinetic (PK) analysis was group of participants who received at least 1 dose of lenvatinib and had sufficient data from which at least one PK parameter could be calculated.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2576110|NCT02454478|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||Baseline up to 30 days after the last dose of study drug (up to approximately 21.5 months)|The safety analysis set was the group of participants who received at least 1 dose of lenvatinib.|||participants|||Number
2576111|NCT02454478|Primary|Number of Participants Who Experienced Any Dose Limiting Toxicity (DLT)|DLT was defined as toxicity related to the combination therapy and was graded according to Common Terminology Criteria for Adverse Events version 4.03 (CTCAE v4.03).|From first dose of study drug up to Cycle 1 Day 28 (Cycle length=28 days)|The DLT analysis set was the group of participants who had completed treatment Cycle 1 without major protocol deviation with a treatment compliance of at least 75 percent (%) and had been assessed for DLT, and participants who had experienced DLT during Cycle 1.|||participants|||Number
2576112|NCT02454296|Secondary|Paracervical or Sham Block Pain|Participants reported her pain level on the 100 mm Visual Analog Scale (VAS) within 10 seconds after she received either the paracervical block or the sham block. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt.|Within 10 seconds after receiving paracervical or sham block||||units on a scale (100 mm VAS)||Inter-Quartile Range|Median
2576113|NCT02454296|Secondary|Satisfaction With Overall Pain Control (100 mm Visual Analog Scale)|Patients rated their satisfaction with overall pain control on the 100 mm VAS, with 0 as not satisfied at all and 100 as completely satisfied|15 minutes post-operatively||||units on a scale (100 mm VAS)||Inter-Quartile Range|Median
2576114|NCT02454296|Primary|Pain After Placement of Laminaria (100 mm Visual Analog Scale)|We asked the participant to rate her pain on a 100 mm Visual Analog Scale (VAS) immediately after laminaria was placed. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt.|Measured within 10 seconds after placement of laminaria||||units on a scale (100 mm VAS)||Inter-Quartile Range|Median
2576115|NCT02454283|Secondary|Length of Stay (From Time of Study Drug Administration)||8 days||||days||Standard Deviation|Mean
2576116|NCT02454283|Primary|Conversion to Sinus Rhythm|Conversion to sinus rhythm (or atrial paced rhythm in the case of subjects with a pacemaker and atrial leads) documented by ECG (Holter ECG, 12-lead ECG, monitor lead ECG, or other format ECG) of at least 1 continuous minute within the 24 hours defined by the time of study drug administration through 24 hours after the time of study drug administration.|24 hours||||participants|||Number
2576117|NCT02454179|Primary|Number of Participants With Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|52 weeks|"The study participants had to have a minimum of one scan (for tumor assessment) after randomization/treatment in order to be considered analyzed.~And some of the participants didn’t make it to Wk 7 of treatment, hence reduction in the number of subjects analyzed."|||Participants|||Count of Participants
2576118|NCT02454127|Secondary|C-reactive Protein|Change from baseline high-sensitivity CRP at 1 year, measured in mg/L|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values.|||mg/L||Standard Deviation|Mean
2576119|NCT02454127|Secondary|Insulin|Change from baseline insulin at 1 year, measured in microIU/mL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values|||microIU/ml||Standard Deviation|Mean
2576120|NCT02454127|Secondary|Glucose|Change from baseline glucose at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values.|||mg/dL||Standard Deviation|Mean
2576121|NCT02454127|Secondary|Triglycerides|Change from baseline triglycerides at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values|||mg/dL||Standard Deviation|Mean
2576122|NCT02454127|Secondary|HDL Cholesterol|Change from baseline HDL cholesterol at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values.|||mg/dL||Standard Deviation|Mean
2576123|NCT02454127|Secondary|LDL Cholesterol|Change from baseline LDL cholesterol at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values|||mg/dL||Standard Deviation|Mean
2576124|NCT02454127|Secondary|Total Cholesterol|Change in total cholesterol from baseline at 1 year, measured in mg/dL|1 year|Intent-to-treat analysis. Missing data were replaced with baseline data.|||mg/dL||Standard Deviation|Mean
2576125|NCT02454127|Primary|Weight Loss|Change from baseline body weight at 1 year, measured in kilograms|1 year|Intent-to-treat analysis. Missing data were replaced with baseline values.|||kg||Standard Deviation|Mean
2576126|NCT02454101|Secondary|Duration of Third Stage of Labor|number of minutes from delivery of the baby till delivery of the placenta|immediatly after delivery||||minutes||Standard Deviation|Mean
2576127|NCT02454101|Secondary|Maternal Additional Need for Therapeutic Uterotonics|number of mothers need for > 20 units of Oxycontin in the 1st 24 hours of delivery|1st 24 hours of delivery||||participants|||Number
2576128|NCT02454101|Secondary|Maternal Need for Blood Transfusion.|number of mothers with hemoglobin level < 7mg/dl and need for blood transfusion|1st 24 hours after delivery||||participants|||Number
2576129|NCT02454101|Secondary|Neonatal Apgar Score (After 5 Minutes of Delivery).|"The Apgar test is done by a doctor, midwife, or nurse. The health care provider examines the baby's:~Breathing effort~Heart rate~Muscle tone~Reflexes~Skin color~Each category is scored with 0, 1, or 2, depending on the observed condition.~The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth.~A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. A score of 10 is very unusual, since almost all newborns lose 1 point for blue hands and feet, which is normal for after birth.~Any score lower than 7 is a sign that the baby needs medical attention. The lower the score, the more help the baby needs"|5 minutes of delivery|Number of Infants Analyzed|||Scores on a Scale from 1 to 10||Standard Deviation|Mean
2576131|NCT02454101|Secondary|Neonatal Intubation|number of newborns requirng intubation in the first 2 hours after delivery|1st 2 hours after delivery|Number of Infants Analyzed|||participants|||Number
2576135|NCT02453841|Secondary|Amount of Bleeding|A four point scale (none, minimal, moderate/diffuse ooze, severe/brisk) completed by the surgeon after removal of the oxymetazoline soaked pledgets.|intraoperative||||Participants|||Count of Participants
2576136|NCT02453841|Secondary|Ease of Hemostasis|A six point scale (very easy, easy, usual, some effort, difficult, extremely difficult) completed by the surgeon at the end of surgery.|intraoperative||||Participants|||Count of Participants
2576137|NCT02453841|Primary|Heart Rate Following Oxymetazoline Administration.|Heart rate was recorded at 5 minute intervals until discharge from the post-anesthesia care unit (PACU) or the final blood draw (150 mins. after administration), whichever came first.|5 - 150 mins. after administration||||beats per minute||Standard Deviation|Mean
2576138|NCT02453841|Primary|Blood Pressure Following Oxymetazoline Administration|Blood pressure was recorded at 5 minute intervals until discharge from the post-anesthesia care unit (PACU) or the final blood draw (150 mins. after administration), whichever came first.|5 - 150 mins. after administration||||mmHg||Standard Deviation|Mean
2576139|NCT02453750|Secondary|Number of Participant With Bronchodilator Response|defined as a = or > 12% change in FEV1 post bronchodilator|life time of child (age 6 to present age)|all subjects performed PFTs|||participants|||Number
2576140|NCT02453750|Secondary|Number of Participant With Elevated Exhaled Nitric Oxide (NO) Level|"exhaled NO measurements will be performed according to the American Thoracic Society and European Respiratory Society guidelines. These tests are performed routinely as part of the respiratory evaluation of these patients and are not additional tests added for this study.~greater than 20 ppb was considered elevated"|30 min|only 12 performed eNO|||Participants|||Count of Participants
2576141|NCT02453750|Secondary|Number of Participant With Elevated Sputum Neutrophils|Elevation is defined as sputum neutrophils > or = 61% neutrophils = neutrophilic inflammation|Baseline, +30 minutes|15 gave reasonable sputum|||participants|||Number
2576142|NCT02453750|Primary|Number of Participants With Elevated Sputum Eosinophils|Number of participants with sputum eosinophils greater than 3% percent of cells in the sputum|post sputum induction|15 gave reasonable sputum for analysis, none had elevated sputum eosinophils|||participants|||Number
2576143|NCT02453711|Secondary|Anti-semaglutide Antibodies During and After Treatment|Participants were tested for anti-semaglutide antibodies from week 0 (post treatment) to week 52 (at weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52). This outcome measure is applicable only for the semaglutide treatment arms.|Week 0-52|Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment.|||Participants|||Count of Participants
2576144|NCT02453711|Secondary|Change in Mental Health Assessed by PHQ-9|Patient health questionnaire-9 (PHQ-9) was recorded at baseline (week 0) and week 52. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. On the PHQ-9, the participant rates the frequency of 9 items on a scale from 0 (not at all) to 3 (nearly every day). The PHQ-9 total score ranges from 0−27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15−19 represent moderately severe depression and total scores of 20-27 represent severe depression. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.|Week 0, week 52|Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment. Number Analyzed = number of participants in the SAS with available data.|||Score on a scale||Standard Deviation|Mean
2576145|NCT02453711|Secondary|Change in Mental Health Assessed by C-SSRS|Presented results are the number of participants with Columbia Suicidality Severity Rating Scale (C-SSRS) results recorded during baseline (week 0) and post baseline (week 4-52) visits. For classification of the events reported on the C-SSRS, the following categories were used: 1) Suicidal ideation, 2) Suicidal behaviour and 3) Non-suicidal self-injurious behaviour. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.|Week 0 and Week 4-59|Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment. Number Analyzed = number of participants in the SAS with available data.|||Participants|||Count of Participants
2576146|NCT02453711|Secondary|Change in Biochemistry: TSH|Change from baseline (week 0) in thyroid stimulating hormone (TSH) was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.|Week 0, week 52|Overall number of participants analyzed = number of participants in the SAS with available data. SAS included all participants receiving at least one dose of the randomised treatment.|||Milli-international units/litre (mIU/L)||Standard Deviation|Mean
2576147|NCT02453711|Secondary|Change in Biochemistry: Calcitonin|Change from baseline (week 0) in calcitonin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.|Week 0, week 52|Overall number of participants analyzed = number of female participants in the SAS with available data. SAS included all participants receiving at least one dose of the randomised treatment.|||Nanogram/litre (ng/L)||Standard Deviation|Mean
2576148|NCT02453711|Secondary|Change in Biochemistry: Albumin|Change from baseline (week 0) in albumin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.|Week 0, week 52|Overall number of participants analyzed = number of participants in the SAS with available data. SAS included all participants receiving at least one dose of the randomised treatment.|||Gram/decilitre (g/dL)||Standard Deviation|Mean
2576149|NCT02453711|Secondary|Change in Biochemistry: Urea, Sodium, Potassium and Calcium (Total)|"Change from baseline (week 0) in biochemistry parameters, urea, sodium, potassium and calcium (total) were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration."|Week 0, week 52|Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment. Number Analyzed = number of participants in the SAS with available data.|||Millimole/litre (mmol/L)||Standard Deviation|Mean
2576150|NCT02453711|Secondary|Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP|"Change from baseline (week 0) in biochemistry parameters, creatinine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration."|Week 0, week 52|Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment. Number Analyzed = number of participants in the SAS with available data.|||Unit/litre (U/L)||Standard Deviation|Mean
2576151|NCT02453711|Secondary|Change in Biochemistry: Creatinine and Bilirubin (Total)|"Change from baseline (week 0) in biochemistry parameters, creatinine and bilirubin (total) were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration."|Week 0, week 52|Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment. Number Analyzed = number of participants in the SAS with available data.|||Micromole/litre (umol/L)||Standard Deviation|Mean
2576152|NCT02453711|Secondary|Change in Haematology: Erythrocytes|Change from baseline (week 0) in erythrocytes was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.|Week 0, week 52|Overall number of participants analyzed = number of participants in the SAS with available data. SAS included all participants receiving at least one dose of the randomised treatment.|||10^12 cells/litre (L)||Standard Deviation|Mean
2576153|NCT02453711|Secondary|Change in Haematology: Thrombocytes, Leucocytes and Differential Count|"Change from baseline (week 0) in haematological parameters, thrombocytes, leucocytes and differential cell count (eosinophils, neutrophils, basophils, monocytes and lymphocytes) were evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration."|Week 0, week 52|Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment. Number Analyzed = number of participants in the SAS with available data.|||10^9 cells/litre (L)||Standard Deviation|Mean
2576154|NCT02453711|Secondary|Change in Haematology: Haematocrit|Change from baseline (week 0) in haematocrit was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.|Week 0, week 52|Overall number of participants analyzed = number of participants in the SAS with available data. SAS included all participants receiving at least one dose of the randomised treatment.|||Percentage of red blood cells||Standard Deviation|Mean
2576155|NCT02453711|Secondary|Change in Haematology: Haemoglobin|Change from baseline (week 0) in haemoglobin was evaluated at week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.|Week 0, week 52|Overall number of participants analyzed = number of participants in the SAS with available data. SAS included all participants receiving at least one dose of the randomised treatment.|||Millimoles per litre (mmol/L)||Standard Deviation|Mean
2576156|NCT02453711|Secondary|Change in Pulse|Change from baseline (week 0) in pulse rate was evaluated at week 52. Analysis of observed data using a mixed model for repeated measurements (MMRM) with treatment, region and sex as factors and baseline pulse as covariate, all nested within visit. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.|Week 0, week 52|Overall number of participants analyzed = number of participants in the SAS with available data. SAS included all participants receiving at least one dose of the randomised treatment.|||Beats per minute||Standard Error|Least Squares Mean
2576157|NCT02453711|Secondary|Change in ECG|"Number of participants with electrocardiogram (ECG) results, normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS) was recorded at baseline (week 0) and week 52. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration."|Week 0, week 52|Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment. Number Analyzed = number of participants in the SAS with available data.|||Participants|||Count of Participants
2576158|NCT02453711|Secondary|Nausea: Individual Scores of Nausea Questionnaire and Severity by NRS Score|This outcome measure presents results recorded at week 52. If a participant experienced an event of nausea within 24 hours prior to a site visit, a nausea questionnaire had to be completed. Participants experiencing such events were to answer 5 different categories in the questionnaire ('duration of nausea', 'time from the latest injection of trial product to the onset of nausea', 'time from last food intake to the onset of nausea', 'nausea accompanied by vomiting (yes/no)' and 'severity of nausea (worst during episode)'). Severity of nausea was recorded on a 0 to 10 numeric rating scale (NRS), where 0 = 'No nausea' and 10 = 'Nausea as bad as it could be'. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.|Week 52|Overall number of participants analyzed = number of participants in the SAS who experienced an event of nausea within 24 hours prior to the site visit at week 52. SAS included all participants receiving at least one dose of the randomised treatment.|||Events|Nausea events||Number
2576159|NCT02453711|Secondary|Number of New and Ongoing Nausea, Vomiting, Diarrhoea, and Constipation Events by Week|Presented results are the number of nausea, vomiting, diarrhoea, and constipation events recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.|Week 0-59|Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment.|||Events|||Number
2576160|NCT02453711|Secondary|Number of Hypoglycaemic Episodes During the Trial|Hypoglycaemic episodes were identified by either: 1) Subject reporting of symptoms of hypoglycaemia (low blood sugar) or 2) fasting plasma glucose (FPG) values ≤3.9 mmol/L (70 mg/dL) from blood sampling at site visits. Hypoglycaemic episodes were recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.|Week 0-59|Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment.|||Episodes|||Number
2576161|NCT02453711|Secondary|Number of AEs During the Trial|Adverse events (AEs) were recorded from week 0 to week 59. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.|Week 0-59|Overall number of participants analyzed = SAS which included all participants receiving at least one dose of the randomised treatment.|||Events|||Number
2576162|NCT02453711|Secondary|Compliance With Nutritional Counselling|"This outcome measure presents nutritional compliance results recorded at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52. Nutritional compliance was recorded on a 0 to 10 numeric rating scale (NRS), with higher scores representing better compliance."|Week 4-52|Overall number of participants analyzed = FAS which included all randomised participants. Number Analyzed = number of participants in the FAS with available data.|||Score on a scale||Standard Deviation|Mean
2576163|NCT02453711|Secondary|Participants With Change in Concomitant Medications (Antihypertensive and Lipid-lowering Medications)|Participants' status on receiving concomitant medication (antihypertensive and lipid-lowering medications) at week 0 (yes/no) and week 52 (decreased, no change, increased or missing) are presented. Results are based on the on-treatment observation period which was defined as the period from first trial product administration to last trial product administration.|Week 0, Week 52|Overall number of participants analyzed = FAS which included all randomised participants. Number Analyzed = number of participants in the FAS with available data.|||Participants|||Count of Participants
2576164|NCT02453711|Secondary|Change in SF-36|Short Form-36 (SF-36) is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at week 52. A positive change score indicates an improvement since baseline. Results are based on the in-trial observation period.|Week 0, Week 52|Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.|||Score on a scale||Standard Deviation|Mean
2576165|NCT02453711|Secondary|Change in IWQoL Lite|The planned analyses of the Impact of Weight on Quality of Life Lite (IWQoL-Lite) for Clinical Trials scores were not performed. The measure was still under development, and Novo Nordisk had not obtained a validated scoring of the instrument by the time of analysis of the trial results. Therefore, the total and subdomain scores on the IWQoL-Lite could not be provided.|Week 0, Week 52|This outcome measure was not analysed.||||||
2576166|NCT02453711|Secondary|Change in hsCRP|Change from baseline (week 0) in high-sensitivity C-reactive protein (hsCRP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline hsCRP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.|Week 0, Week 52|Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.|||Milligrams per decilitre (mg/dL)||Standard Error|Least Squares Mean
2576167|NCT02453711|Secondary|Change in Lipids (Total Cholesterol, LDL Cholesterol, HDL Cholesterol, VLDL Cholesterol, Triglycerides and FFA)|Change from baseline (week 0) in lipids (total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, very low density lipoprotein (VLDL) cholesterol and triglycerides) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and respective baseline lipid value as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site. Free fatty acid (FFA) results are not presented as the values were considered invalid. The shipment of the samples to be tested for FFA was not as per the requirement.|Week 0, Week 52|Overall number of participants analyzed = FAS which included all randomised participants. Number Analyzed = number of participants in the FAS who contributed to the analysis.|||Millimoles per litre (mmol/L)||Standard Error|Least Squares Mean
2576168|NCT02453711|Secondary|Change in DBP|Change from baseline (week 0) in diastolic blood pressure (DBP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline DBP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.|Week 0, Week 52|Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.|||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2576169|NCT02453711|Secondary|Change in SBP|Change from baseline (week 0) in systolic blood pressure (SBP) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline SBP as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.|Week 0, Week 52|Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.|||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2576170|NCT02453711|Secondary|Change in Glycaemic Category (Normoglycaemia, Pre-diabetes, T2D)|The categorisation of glycaemic status as described in the protocol was not aligned with the usual diagnosis criteria which require repeated testing of blood glucose to confirm the diagnosis and allows for the diagnosis to be made based on random glucose assessments and/or 2-hour glucose assessments during an oral glucose tolerance test. Therefore, data were not collected for this outcome measure.|Week 0, Week 52|Data were not collected for this outcome measure.||||||
2576171|NCT02453711|Secondary|Change in FPG|Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline FPG as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.|Week 0, Week 52|Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.|||Millimoles per litre (mmol/L)||Standard Error|Least Squares Mean
2576172|NCT02453711|Secondary|Change in HbA1c|Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline HbA1c as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.|Week 0, Week 52|Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.|||Percentage of HbA1c||Standard Error|Least Squares Mean
2576173|NCT02453711|Secondary|Change in BMI|Change from baseline (week 0) in body mass index (BMI) was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline BMI as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.|Week 0, Week 52|Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.|||Kilogram per square meter (kg/m^2)||Standard Error|Least Squares Mean
2576174|NCT02453711|Secondary|Change in Waist to Hip Circumference Ratio|Change from baseline (week 0) in waist to hip circumference ratio was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline waist to hip circumference ratio as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.|Week 0, Week 52|Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.|||Waist to hip circumference ratio||Standard Error|Least Squares Mean
2576175|NCT02453711|Secondary|Change in Waist Circumference|Change from baseline (week 0) in waist circumference was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline waist circumference as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.|Week 0, Week 52|Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.|||Centimetre (cm)||Standard Error|Least Squares Mean
2576176|NCT02453711|Secondary|Change in Body Weight (kg)|Change from baseline (week 0) in body weight was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. Results are based on the in-trial observation period which was defined as the period from randomisation to last contact with trial site.|Week 0, Week 52|Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.|||Kilogram (kg)||Standard Error|Least Squares Mean
2576177|NCT02453711|Secondary|Participants With Weight Loss of ≥10% of Baseline Body Weight|Presented results are percentage of participants who lost more than or equal to 10% of their baseline (week 0) body weight at week 52. Analysis of observed in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using a binary logistic regression model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.|Week 52|Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.|||Percentage (%) of participants|||Number
2576178|NCT02453711|Secondary|Participants With Weight Loss of ≥5% of Baseline Body Weight|Presented results are percentage of participants who lost more than or equal to 5% of their baseline (week 0) body weight at week 52. Analysis of observed in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using a binary logistic regression model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.|Week 52|Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.|||Percentage (%) of participants|||Number
2576179|NCT02453711|Primary|Relative Change in Body Weight (%)|Relative change from baseline (week 0) in body weight was evaluated at week 52. Analysis of in-trial data with missing observations imputed from the pooled placebo arms based on a jump to reference multiple (x1000) imputation (J2R-MI) approach. Week 52 responses were analysed using an analysis of covariance model with treatment, region and sex as factors and baseline body weight as covariate. In-trial observation period was defined as the period from randomisation to last contact with trial site.|Week 0, Week 52|Overall number of participants analyzed = number of participants in the FAS who contributed to the analysis. FAS included all randomised participants.|||Percentage (%) of body weight||Standard Error|Least Squares Mean
2576810|NCT02447081|Primary|Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death|Occurrence of ischemic stroke, systemic embolism, and cardiovascular death through 2 years|Implant through 2 years||||Participants|||Count of Participants
2576180|NCT02453685|Secondary|Total Daily Insulin Dose|Total daily insulin dose in the basal bolus treatment group and in BIAsp 30 treatment group at each week of each treatment.|Weeks 0-32|Safety analysis set. Number analysed=number of subjects with available data for individual timepoints.|||U/kg||Standard Deviation|Mean
2576181|NCT02453685|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) and the Novo Nordisk Definitions|Hypoglycaemic episodes were classified as severe, Asymptomatic, Documented symptomatic, Pseudo, and Probable symptomatic as per ADA classification. As symptoms of hypoglycaemia occur below a PG level of 3.1 mmol/L, (56 mg/dL) Novo Nordisk classification included hypoglycaemia with plasma glucose (PG) levels below 3.1 mmol/L (56 mg/dL) in the definition of blood glucose confirmed hypoglycaemia. Hence, Novo Nordisk classification included following types of hypoglycaemia in addition to ADA classification: Severe hypoglycaemia, Symptomatic blood glucose confirmed hypoglycaemia, Asymptomatic blood glucose confirmed hypoglycaemia, Severe or blood glucose confirmed symptomatic hypoglycaemia, Blood glucose confirmed hypoglycaemia, and Severe or blood glucose confirmed hypoglycaemia. Reported data represents total of all hypoglycaemic episodes.|Weeks 0-32|The safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator.|||Hypoglycaemic episodes|||Number
2576182|NCT02453685|Secondary|HbA1c Below 7.0% Without Severe Hypoglycaemic Episodes|Percentage of subjects with HbA1c below 7.0% after 32 weeks of randomised treatment without treatment emergent severe hypoglycaemic episodes during the last 12 weeks of treatment. Subjects withdrawn before 32 weeks were handled as non-responders. Severe hypoglycaemic episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG concentration.|After 32 weeks of treatment (yes/no)|Full analysis set.|||Percentage of subjects|||Number
2576183|NCT02453685|Primary|Change in HbA1c (Glycosylated Haemoglobin)|Change in HbA1c from baseline (week 0) to week 32.|Week 0, week 32|Full analysis set. Week 32 data are presented after application of Last observation carried forward; 164 subjects contributed in each arm.|||Percentage of HbA1c||Standard Deviation|Mean
2576184|NCT02453672|Secondary|Time to Reach Cmax (Tmax)|0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion.|0 to 2016 hours after start of infusion|Among the subjects discountinued, subjects with major protocol deviations were excluded from the PK population for the PK analysis.|||h||Standard Deviation|Mean
2576185|NCT02453672|Primary|Maximum Serum Concentration (Cmax)|0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion.|0 to 2016 hours after start of infusion|Among the subjects discountinued, subjects with major protocol deviations were excluded from the PK population for the PK analysis.|||μg/mL||Standard Deviation|Mean
2576186|NCT02453672|Primary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)|0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion.|0 to 2016 hours after start of infusion|Among the subjects discountinued, subjects with major protocol deviations were excluded from the PK population for the PK analysis.|||h·μg/mL||Standard Deviation|Mean
2576187|NCT02453672|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)|0 (pre-dose), 0.75, 1.5 (end of infusion), 3, 6, 12, 24, 48, and 96 hours, then at Day 8 (168 h), 15 (336 h), 22 (504 h), 29 (672 h), 43 (1008 h), 57 (1344 h), 71 (1680 h), and 85 (2016 h) after start of infusion.|0 to 2016 hours after start of infusion|Among the subjects discountinued, subjects with major protocol deviations were excluded from the PK population for the PK analysis.|||h·μg/mL||Standard Deviation|Mean
2576188|NCT02453581|Primary|500mg Cohort Mean Parasite Reduction Ratio (PRR)|OZ439 500mg individual subject PRR and corresponding 95% CI were used to calculate the OZ439 500mg cohort specific PRR and the corresponding 95% CI: the weighted average slope estimate and corresponding SE were calculated by the inverse-variance method.|48 hours|As the doses of 100 mg and 200 mg of OZ439 in Cohorts 1 and 2 were inadequate to eliminate the parasites and regrowth occurred, PRR calculations were only undertaken for subjects receiving 500mg of OZ439 in Cohort 3. With a p value of 0.0046, Subject S036 was excluded from this calculation|||none (ratio)||95% Confidence Interval|Mean
2576189|NCT02453581|Secondary|OZ439 AUC(0-144)|OZ439 Area under the curve to 144 hours|Pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose|All 24 subjects randomized and completed the study.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2576190|NCT02453581|Secondary|OZ439 Cmax|OZ439 Maximum concentration (Cmax)|Pre-dose, and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 144 hours post-dose|All 24 subjects randomized and completed the study.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2576191|NCT02453581|Primary|Individual Parasite Reduction Ratio (PRR)|"PRR estimates the efficacy of an anti-malarial treatment and is the ratio of the parasite density between admission and 48 hours post-treatment.~Individual subject PRR and corresponding 95% CI were calculated using the slope and corresponding standard error of mean (SE) of the optimal regression model."|48 hours|As the doses of 100 mg and 200 mg of OZ439 in Cohorts 1 and 2 were inadequate to eliminate the parasites and regrowth occurred, PRR calculations were only undertaken for subjects receiving 500mg of OZ439 in Cohort 3.|||none (ratio)||95% Confidence Interval|Number
2576192|NCT02453555|Secondary|Change in HbA1c From Baseline at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Versus All Placebo)|Change from baseline in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.|Baseline and 52 week|Full analysis set with up-titration-II consisted patients who were up-titrated to Empagliflozin 25/linagliptin 5 and were treated with at least 1 dose after dose up-titration and who were randomized to receive Linagliptin 5 + Placebo 10 or Linagliptin 5 + Placebo 25 and who had HbA1c assessment at baseline and at least once after dose up-titration.|||Percentage (%)||Standard Error|Least Squares Mean
2584034|NCT02359903|Secondary|Time of Maximum Concentration of Infliximab After the1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade||28 weeks|||||||
2576193|NCT02453555|Secondary|Change in HbA1c From Baseline at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Versus Linagliptin 5 mg + Placebo 25 mg)|Change from baseline in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.|Baseline and 52 week|FASUT-I|||Percentage (%)||Standard Error|Least Squares Mean
2576194|NCT02453555|Secondary|Change in HbA1c From Baseline at Week 52 (All Empagliflozin Versus All Placebo)|Change from baseline in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.|Baseline and 52 week|The analysis was performed on the FAS (observed case [OC]) with treatment assignment as randomised.|||Percentage (%)||Standard Error|Least Squares Mean
2576195|NCT02453555|Secondary|Change in HbA1c From Week 28 at Week 52 (Empagliflozin 25 mg/Linagliptin 5 mg Only)|"Change from Week 28 in HbA1c at Week 52 was calculated as: HbA1c at Week 52 - HbA1c at Week 28. Week 28 (pre up-titration) is referred to the last observed measurement prior to the first administration of any double-blind randomized trial medication in the up-titration period. Adjusted mean (Least square mean) and its standard error (SE) is presented.~This endpoint was based on 1 group of the Full analysis set with up-titration (FASUT-II) whose dose was up-titrated to Empagliflozin 25 mg/Linagliptin 5 mg fixed dose combination thus there is no comparison group. Hence, no comparison is made. A restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach was used with baseline HbA1c as linear covariate and baseline eGFR, prior use of antidiabetic drug, visit as fixed effect(s). The covariance used to fit the model was unstructured."|28 Week (pre up-titration) and 52 Week|The full analysis set with up-titration-I (FASUT-I) consisted of all patients who were up-titrated and were treated with at least 1 dose of Empagliflozin 25 mg/linagliptin 5 mg or Linagliptin 5 mg + Placebo 25 mg after dose up-titration and who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment after dose up-titration.|||Percentage (%)||Standard Error|Least Squares Mean
2576196|NCT02453555|Primary|Change of Glycosylated Haemoglobin A1c (Glycosylated Haemoglobin A1c After 24 Weeks of Double-blind Treatment From Baseline)|Change from baseline in Glycosylated haemoglobin A1c (HbA1c) at Week 24 was calculated as: HbA1c at Week 24 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.|Baseline and 24 week|The primary analysis was performed on the FAS (observed case [OC]) with treatment assignment as randomised.|||Percentage (%)||Standard Error|Least Squares Mean
2576197|NCT02453386|Other Pre-specified|Patient Global Impression of Improvement (PGI-I) Week 24|"For the Patient Global Impression of Improvement (PG-I), the patient is asked to rate the total improvement of their Parkinson's Disease, whether or not in the patient's judgment it is due entirely to drug treatment, based on a 1-7 point weighted scale. very much improved (1) to very much worse (7). A zero score is assigned if the score is not assessed.~Scale: 1 = Normal, not at all ill, 2 = Borderline ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severly ill, 7 = Among the most extremely ill.~Tables show Treatment vs Placebo."|At Week 24|mITT population (Modified Intent-to-Treat) - all safety set patients who had valid diaries at baseline and had valid diaries on at least 1 post-baseline visit. Patients were accounted for in the treatment group to which they were originally randomized.|||score on a scale||Standard Deviation|Mean
2576198|NCT02453386|Other Pre-specified|Global Assessments of Improvement: Clinical Global Impression of Improvement (CGI-I) Week 24|"For the Clinical Global Impression of Improvement (CGI-I), the investigator or rater is asked to rate the patient's total improvement, whether or not in his or her judgment it is due entirely to drug treatment, based on a 1-7 point weighted scale ranging from very much improved (1) to very much worse (7). A zero score is assigned if the score is not assessed. Scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. Tables show Treatment vs Placebo."|At Week 24|mITT population (Modified Intent-to-Treat) - all safety set patients who had valid diaries at baseline and had valid diaries on at least 1 post-baseline visit. Patients were accounted for in the treatment group to which they were originally randomized.|||score on a scale||Standard Deviation|Mean
2576199|NCT02453386|Secondary|Change From Baseline to Week 24 in the ON State in Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl|"Change from Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS) Parts III Motor Function (motor subscale) total scores. Each subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Range of score is 0 - 108. Higher scores indicate greater impact of PD symptoms. Unified Parkinson's Disease Rating Scale (UPDRS) in the ON state was measured at a time representative of the ON state in that patient, not in best ON. Unified Parkinson's Disease Rating Scale Part III in OFF was not evaluated."|Baseline to Week 24|mITT population (Modified Intent-to-Treat) - all safety set patients who had valid diaries at baseline and had valid diaries on at least 1 post-baseline visit.|||score on a scale||Standard Deviation|Mean
2576200|NCT02453386|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Activities of Daily Living (ADL) Subscale + Part III Motor Function|"The Unified Parkinson's Disease Rating Scale (UPDRS) is a scale to monitor Parkinson's Disease related disability and impairment. The scale itself has 4 components are titled; (1) nonmotor experiences of daily living (13 items), (2) motor experiences of daily living (13 items), (3) motor examination (18 items), and (4) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. In this outcome measure we are evaluating Part II and Part III.~Part II: self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food Part III: clinician-scored monitored motor evaluation Range of score is 0 - 160: 0 meaning less impact and Higher score indicates greater impact of PD symptoms."|Baseline to Week 24|mITT population (Modified Intent-to-Treat) - all safety set patients who had valid diaries at baseline and had valid diaries on at least 1 post-baseline visit.|||score on a scale||Standard Deviation|Mean
2576404|NCT02451943|Secondary|Duration of Disease Control (DDC)|Duration of disease control was defined for each participant with a best response of CR, PR, or stable disease (SD) as the time from randomization to the first date of disease progression or death due to any cause.|Date of CR, PR, or SD to Objective Disease Progression or Death Due to Any Cause (Up to 35.8 Months)|All randomized participants who had evaluable DDC data.|||Months||95% Confidence Interval|Median
2576201|NCT02453386|Secondary|Change in Good ON Time From Baseline to Week 24|"The first key secondary efficacy endpoint was the change from baseline to Week 24 in good ON which was defined as ON without dyskinesia or ON with non-troublesome dyskinesia.~Awake Time in Good ON State (hr) is the average of a maximum of 3 days diary. Patients were asked to record ON time according to dyskinesia categories without dyskinesia, with non troublesome dyskinesia or with troublesome dyskinesia . Patients (and/or caregivers) were trained to complete the PD diary to record their status at half hourly intervals as OFF, ON without dyskinesia, ON with non troublesome dyskinesia, ON with troublesome dyskinesia, or asleep. For patients with missing baseline or baseline was measured post-dose, screening was used as baseline in the calculation of change from baseline."|Baseline to 24 Weeks|Modified Intent-to-Treat (mITT) population|||hours||Standard Deviation|Mean
2576202|NCT02453386|Primary|Change From Baseline to Week 24 in the Number of Hours Per Day Spent in OFF Time|"Awake time in OFF state (hr) is the average of maximum of 3 days diary. The primary efficacy endpoint was the change from baseline to Week 24 in OFF time, where OFF time in the Hauser Parkinson's Disease Home Diary (PD) was averaged over 3 days prior to the study visit. During Screening and through Part A of the study, the Hauser Parkinson's Disease Home Diary (PD) was completed on specified days directly preceding the scheduled study visits/assessments. Motor activity was recorded as OFF, ON (mobility improved), or asleep time. Patients were asked to record ON time according to dyskinesia categories without dyskinesia, with non troublesome dyskinesia or with troublesome dyskinesia. Patients (and/or caregivers) were trained to complete the PD diary to record their status at half hourly intervals as OFF, ON without dyskinesia, ON with non troublesome dyskinesia, ON with troublesome dyskinesia, or asleep."|Baseline to 24 Weeks|Modified Intent-to-Treat (mITT) population|||hours||Standard Deviation|Mean
2576203|NCT02453360|Secondary|Number of Participants With Nausea at 24 Hours|Need for antiemetic therapy will be assessed through evaluation of the electronic medical record.|Perioperative through 48 hours postoperatively||||Participants|||Count of Participants
2576204|NCT02453360|Secondary|Percentage Change in Knee Extension Strength From Baseline|Patient strength will be assessed by asking subjects to maximally adduct their leg or extend their knee for five seconds. Subjects will be asked to repeat this measurement three times at each measurement (pre-block, 15 minutes post-block, 24 hours post-block and 48 hours post-block). Strength measurements will be made with the Kiio strength monitoring device.|24 Hours Following Surgery|Incomplete data responsible for discrepancies between number of subjects enrolled and data reported.|||percentage change of Baseline Strength||Standard Deviation|Mean
2576205|NCT02453360|Secondary|Pain With Activity at 24 Hours|Patient pain will be assessed by having participants describe pain using Numerical Ranking Scale (NRS) with a total score of 0-10 where 0 is no pain and 10 is the worst pain imaginable. Location of pain will also be assessed.|24 Hours Following Surgery|Incomplete data responsible for discrepancies between number of subjects enrolled and data reported.|||Scores on a scale||Standard Deviation|Mean
2576206|NCT02453360|Secondary|Opioid Consumption|Opioid Requirements will be retrieved from the patient's electronic medical record|PACU Discharge through 24 hours postoperatively||||Morphine Equivalents (mg)||Standard Deviation|Mean
2576207|NCT02453360|Primary|10 Meter Walk Test|This will be evaluated by determining how quickly a patient is able to ambulate over 10 meters on POD 1 (10 meter walk test).|24 hours postoperatively following total knee arthroplasty|Incomplete data responsible for discrepancies between number of subjects enrolled and data reported.|||Seconds||Standard Deviation|Mean
2576208|NCT02453347|Secondary|Sleep - Pittsburgh Sleep Quality Index (PSQI)|"To assess for improvements in measures of somatic symptoms related to TBI (insomnia). The scoring consists of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.~Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality."|Four Weeks||||scores on a scale||Standard Deviation|Mean
2576209|NCT02453347|Secondary|Headache - HIT6 (Headache Impact Test)|To assess for improvements in measures of somatic symptoms related to TBI (headaches). The test is scored by adding points to 6 different categories related to frequency and severity of symptoms. The 6 category scores are summed to yield a total score ranging from 36 to 78. Fewer points signify less severity and higher point scores signify more severe symptoms according to patient assessment.|Four Weeks||||scores on a scale||Standard Deviation|Mean
2576210|NCT02453347|Secondary|Dizziness- NSI (Neurobehavioral Symptom Inventory)|To measure the effect of CES use on somatic symptoms related to TBI (Traumatic Brain Injury), including dizziness. The assessment scale rate 22 symptoms that may have disturbed subjects from 0 = no symptoms to 4 = very severe in the previous 2 weeks. The scores are summed to yield a total score ranging from 0 to 88, where the higher the point value, the greater the symptoms.|Four Weeks||||scores on a scale||Standard Deviation|Mean
2576211|NCT02453347|Primary|WAIS Coding - Wechsler Adult Intelligence Scale|"The test has two batteries of subtests grouped into two general areas: 1) Verbal scales; and 2) Performance scales. The Verbal scales measure general knowledge, language, reasoning, and memory skills, while the Performance scales measure spatial, sequencing, and problem-solving skills.~The tests are administered to individual examinees by trained examiners, using a complex set of test materials. Testing requires approximately 90 minutes. Raw scores on each test are converted to standard scores with a mean of 10 and a standard deviation of 3. Scale scores in the Verbal battery are summed and converted to a Verbal Intelligence Quotient (IQ) score; the same is done for the Performance scale scores which yield the Performance IQ score. In turn, the Verbal and Performance IQ scores are summed and converted to obtain the Full Scale (overall) IQ score with a mean of 100 and a standard deviation of 15. Higher scores indicate a higher IQ."|4 weeks||||scores on a scale||Standard Deviation|Mean
2576212|NCT02453347|Primary|WAIS (Wechsler Adult Intelligence Scale) Symbol Search|The Symbol Search subtest of the Wechsler Adult Intelligence scale designed to assess information processing speed and visual perception with a minimum score of 0 as the lowest (worst performance) to 60 as the highest score (best performance).|4 weeks||||scores on a scale||Standard Deviation|Mean
2579240|NCT02418026|Secondary|Score at Numeric Pain Rating Scale|The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)|just after surgery, up to 1 hour||||units on a scale||Standard Deviation|Mean
2576213|NCT02453347|Primary|MPAI (Mayo Portland Adaptability Inventory)|The inventory consists of 29 items in 3 subscales (Ability, the Adjustment and Participation Index) plus an additional 6 items that are not included in the MPAI-4 score. The first 29 scale items are intended to reflect the current status of the individual with brain injury without attempting to determine whether their status might be influenced by factors other than ABI (acquired brain injury). Items are scored from 0 to 4, with 0 being the most favorable score for each item, with a cumulative score ranging from 0 to 116 for all the items. A lower score indicates better adaptability.|4 weeks||||scores on a scale||Standard Deviation|Mean
2576214|NCT02453347|Primary|TFI (Tinnitus Functional Index)|To measure the severity of tinnitus. The survey consists of 25 questions ranked from 0 (did not interfere) to 10 (completely interfered). At least 19 of the 25 questions are required to be answered, and rankings are added together to give a maximum possible score of 250, which would be the most severe interference by tinnitus.|4 weeks||||scores on a scale||Standard Deviation|Mean
2576215|NCT02453347|Primary|Beck Depression Inventory (BDI)|"A 21 question set to assess subjects feelings in the last week. Each question has a set of at least 4 possible responses, ranging in intensity:~(0) I do not feel sad.~I feel sad.~I am sad all the time and I can't snap out of it.~I am so sad or unhappy that I can't stand it. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score ranging from 0 to 63 is compared to a key to determine the depression's severity. Higher total scores indicate more severe depressive symptoms."|4 weeks||||score||Standard Deviation|Mean
2576216|NCT02453347|Primary|State-Trait Anxiety Inventory (STAI)|To measure the effect of CES use on trait and state anxiety. These scales comprise 20 items each and are scored on 4-point forced-choice response scales from 1 (seldom) to 4 (frequent). Scores range from 20 to 80, with higher scores suggesting greater levels of anxiety.The state and trait anxiety scales both range from 20 to 80 and are combined to yield a total score ranging from 40 to 160, where low scores suggest mild anxiety, median scores suggest moderate anxiety, and high scores suggest severe anxiety. Both scales include direct (presence of anxiety) and reverse-worded (absence of anxiety) items. Reverse-worded item scores are reverse scored and then totaled with the remaining items.|Four Weeks||||scores on a scale||Standard Deviation|Mean
2576217|NCT02453347|Primary|PCL-5 (Post Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders) for Use in Treating PTSD Symptoms|"To measure the effect of Cranial Electrotherapy Stimulation (CES) use on symptoms related to PTSD.~The PCL-5 is a self-report measure that can be completed by patients in a waiting room prior to a session or by participants as part of a research study.~The survey has 20 questions scored as:~0=Not at all~A little bit~Moderately~Quite a bit~Extremely Interpretation of the PCL-5 should be made by a clinician. The total symptom severity score is obtained by summing the scores for each of the 20 items and ranges from 0 to 80. The lower the score, the less severe the symptoms of PTSD, the higher the score, the more severe the symptoms. For a person to have a probable diagnosis of PTSD sufficient criteria must be moderately to extremely met in each of the four symptom groups (i.e., one or more of questions 1-5, either question 6 or 7, two or more of questions 8-14, two or more of questions 15-20). In addition, a score of 38 or higher indicates probable PTSD in veterans."|Four Weeks||||scores on a scale||Standard Deviation|Mean
2576218|NCT02453321|Secondary|Sustained Straight Leg Raise|Sustained Straight Leg Raise is the ability to elevate the heel and leg/knee off of bed for 5 seconds postoperatively after spinal anesthetic has resolved contralaterally.|Day of Surgery (DOS) - In Postoperative Recovery Unit, prior to any walking atempt||||Participants|||Count of Participants
2576219|NCT02453321|Secondary|Postoperative Pain, Average Reported Score 11-point Scale|The outcome is measured using a Numeric pain scale. The patient reports their average pain felt on postoperative day one, on a scale of 0 to 10 inclusive. Zero in this case indicates no pain at all and 10 indicates the worst pain they have ever felt.|postoperative day one||||units on scale||Standard Deviation|Mean
2576220|NCT02453321|Secondary|Average Length of Stay (to be Reported in Hours After Surgery)|If pain is controlled and rehabilitation activity is optimal patient may be discharged at an earlier time|Participants will be followed for the duration of hospital stay; No patients will be discharged on the day of surgery; The earliest discharge would be at 24 hours. Those hospitalized beyond 96 hours will be excluded.||||Hours||Inter-Quartile Range|Median
2576221|NCT02453321|Primary|Time to Achieve Physical Therapy Discharge Criteria as Measured by 75-feet Walk Test. {Number of Hours After Conclusion of Surgery}|Ability to walk 75 feet if performed on POD#2 is usually considered the main criterion for discharge at UPMC Passavant. The patient is accompanied/supervised by physical therapist using a walker but without active intervention by therapist, unless necessary. The earliest day on which the patient achieves the 75-feet unassisted walk will be recorded for comparison among the arms/groups.|Participants will be followed for the duration of hospital stay, an average of 4 days||||Hours||Inter-Quartile Range|Median
2576222|NCT02453282|Secondary|Number of Participants With ADA Response to Tremelimumab|Blood samples were measured for the presence of ADAs and ADA-nAb for tremelimumab using validated assays. Tiered analysis was performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples were employed. Immunogenicity results were analyzed by summarizing the number of participants who developed detectable ADAs against tremelimumab. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.|At Weeks 0 and 12; 3 and 6 months after last dose of study treatment.|Safety analysis set included all participants who received at least 1 dose of study treatment. ADA evaluable population included participants who have non-missing baseline tremelimumab ADA and at least one non-missing post-baseline tremelimumab ADA result.|||Participants|||Count of Participants
2576257|NCT02453256|Secondary|Percentage of Participants With Change in Digital Ulcer Count at Week 96|A digital ulcer is defined as an ulcer at or distal to the MCP joint on either the dorsal or volar surface, with loss of surface epithelialization. This does not include fissures, cracks, or calcium extrusions from calcinosis cutis. The number of fingers (0−10) with digital ulcers and the number of digital (or finger) ulcers will be counted and recorded by the investigator.|From Baseline to Week 96|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Percentage of participants|||Number
2576223|NCT02453282|Secondary|Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab|Blood samples were measured for the presence of ADAs and ADA-neutralizing antibodies (nAb) for durvalumab using validated assays. Tiered analysis was performed to include screening, confirmatory, and titer assay components, and positive-negative cut points previously statistically determined from drug-naïve validation samples were employed. Immunogenicity results were analyzed by summarizing the number of participants who developed detectable ADAs against durvalumab. Persistently positive is defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.|At Weeks 0, 12, and 24; 3 and 6 months after last dose of study treatment.|Safety analysis set included all participants who received at least 1 dose of study treatment. ADA evaluable population included participants who have non-missing durvalumab baseline ADA and at least one non-missing post-baseline durvalumab ADA result.|||Participants|||Count of Participants
2576224|NCT02453282|Secondary|Ctrough_ss of Tremelimumab|Blood samples were collected to determine the Ctrough_ss of tremelimumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods.|Pre-dose at Week 12.|The PK analysis set included all participants who received at least 1 dose of study treatment per the protocol for whom any post-dose data are available and who did not violate or deviate from the protocol in ways that would materially affect the PK analyses.|||mcg/mL||Standard Deviation|Mean
2576225|NCT02453282|Secondary|Trough Serum Concentration at Steady State (Ctrough_ss) of Durvalumab|Blood samples were collected to determine the Ctrough_ss of durvalumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods.|Pre-dose at Week 12.|The PK analysis set included all participants who received at least 1 dose of study treatment per the protocol for whom any post-dose data are available and who did not violate or deviate from the protocol in ways that would materially affect the PK analyses.|||mcg/mL||Standard Deviation|Mean
2576226|NCT02453282|Secondary|Cmax_ss of Tremelimumab|Blood samples were collected to determine the Cmax_ss of tremelimumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods.|Within 1 hour after end of infusion on infusion day at Week 12.|The PK analysis set included all participants who received at least 1 dose of study treatment per the protocol for whom any post-dose data are available and who did not violate or deviate from the protocol in ways that would materially affect the PK analyses.|||mcg/mL||Standard Deviation|Mean
2576227|NCT02453282|Secondary|Maximum Serum Concentration at Steady State (Cmax_ss) of Durvalumab|Blood samples were collected to determine the Cmax_ss of durvalumab. Steady state was defined as Cycle 4 (Week 12). PK parameters were determined using standard non-compartmental methods.|Within 1 hour after end of infusion on infusion day at Week 12.|The PK analysis set included all participants who received at least 1 dose of study treatment per the protocol for whom any post-dose data are available and who did not violate or deviate from the protocol in ways that would materially affect the PK analyses.|||mcg/mL||Standard Deviation|Mean
2576228|NCT02453282|Secondary|Serum Concentrations of Tremelimumab|Blood samples were collected to determine the serum concentration of tremelimumab.|Pre-dose and within 1 hour after end of infusion at Week 0 and 12, and at follow-up Month 3.|The PK analysis set included all participants who received at least 1 dose of study treatment per the protocol for whom any post-dose data are available and who did not violate or deviate from the protocol in ways that would materially affect the PK analyses.|||mcg/mL||Standard Deviation|Mean
2576229|NCT02453282|Secondary|Serum Concentrations of Durvalumab|Blood samples were collected to determine the serum concentration of durvalumab.|Pre-dose and within 1 hour after end of infusion at Week 0, 12 and 24, and at follow-up Month 3.|Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of study treatment per the protocol for whom any post-dose data are available and who did not violate or deviate from the protocol in ways that would materially affect the PK analyses.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2576230|NCT02453282|Secondary|Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at 12 Months|Patient reported outcomes for 5 disease related symptoms was assessed using the EORTC QLQ-Core 30 (C30) items questionnaire (fatigue and appetite loss) and the EORTC QLQ-Lung Cancer module 13 (LC13) (dysponea, cough and chest pain). An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items with higher scores representing greater symptom severity. An improvement in symptoms were indicated by a negative change in score from baseline. A positive change in score from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change is defined as an absolute change in the score from baseline of >=10.|At baseline then every 4 weeks for the first 8 weeks relative to the date of randomization, then every 8 weeks until second progression/death, whichever comes first. Assessed up to 12 months.|The PD-L1 (TC >=25%) analysis set included the subset of participants in the FAS whose PD-L1 status was PD-L1 (TC >=25%) as defined by the Ventana PD-L1 (SP263) assay (ie, >=25% TC expressing PD-L1 on the membrane).|||units on a scale||Standard Error|Mean
2576231|NCT02453282|Secondary|PFS2; FAS Population|The PFS2 was defined as the time from the date of randomization to the earliest of the progression events (subsequent to that used for the primary variable PFS and excluding any confirmation of progression scans performed for first progression) or death (ie, date of PFS2 event or censoring - date of randomization + 1). The second progression event was determined by local standard clinical practice which may have included any of the following: objective radiological imaging, symptomatic progression, or death.|Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).|The FAS included all randomized participants analyzed on an ITT basis.|||months||95% Confidence Interval|Median
2576258|NCT02453256|Secondary|Number of Participants With Adverse Events Leading to Death Up to Week 96||Up to Week 96|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Number of participants|||Number
2579898|NCT02412501|Secondary|Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 24 Months Post Procedure|TVMI defined as Q Wave or non-Q Wave MI|24 Months||||Participants|||Count of Participants
2576232|NCT02453282|Secondary|PFS2; PD-L1 (TC >=1%) Analysis Set Population|The PFS2 was defined as the time from the date of randomization to the earliest of the progression events (subsequent to that used for the primary variable PFS and excluding any confirmation of progression scans performed for first progression) or death (ie, date of PFS2 event or censoring - date of randomization + 1). The second progression event was determined by local standard clinical practice which may have included any of the following: objective radiological imaging, symptomatic progression, or death.|Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).|The PD-L1 (TC >=1%) analysis set included the subset of participants in the FAS whose PD-L1 status is PD-L1 (TC >=1%) as defined by the Ventana PD-L1 (SP263) assay (ie, >=1% TC expressing PD-L1 on the membrane).|||months||95% Confidence Interval|Median
2576233|NCT02453282|Secondary|Time From Randomization to Second Progression (PFS2); PD-L1 (TC >=25%) Analysis Set Population|The PFS2 was defined as the time from the date of randomization to the earliest of the progression events (subsequent to that used for the primary variable PFS and excluding any confirmation of progression scans performed for first progression) or death (ie, date of PFS2 event or censoring - date of randomization + 1). The second progression event was determined by local standard clinical practice which may have included any of the following: objective radiological imaging, symptomatic progression, or death.|Tumour scans performed at baseline then every 6 weeks up to Week 48, then every 8 weeks thereafter until 1st progression. Disease then assessed per local practice until 2nd progression. Assessed up to data cut-off date (maximum of approximately 3 years).|The PD-L1 (TC >=25%) analysis set included the subset of participants in the FAS whose PD-L1 status was PD-L1 (TC >=25%) as defined by the Ventana PD-L1 (SP263) assay (ie, >=25% TC expressing PD-L1 on the membrane).|||months||95% Confidence Interval|Median
2576234|NCT02453282|Secondary|Percentage of Participants APF12; FAS Population|The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 12 months after randomization. The PFS was calculated using the Kaplan-Meier technique.|Tumour scans performed at baseline then every 6 weeks up to 12 months.|The FAS included all randomized participants analyzed on an ITT basis.|||percentage of participants||95% Confidence Interval|Number
2576235|NCT02453282|Secondary|Percentage of Participants APF12; PD-L1 (TC >=1%) Analysis Set Population|The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 12 months after randomization. The PFS was calculated using the Kaplan-Meier technique.|Tumour scans performed at baseline then every 6 weeks up to 12 months.|The PD-L1 (TC >=1%) analysis set included the subset of participants in the FAS whose PD-L1 status is PD-L1 (TC >=1%) as defined by the Ventana PD-L1 (SP263) assay (ie, >=1% TC expressing PD-L1 on the membrane).|||percentage of participants||95% Confidence Interval|Number
2576236|NCT02453282|Secondary|Percentage of Participants Alive and Progression Free at 12 Months (APF12); PD-L1 (TC >=25%) Analysis Set Population|The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 12 months after randomization. The PFS was calculated using the Kaplan-Meier technique.|Tumour scans performed at baseline then every 6 weeks up to 12 months.|The PD-L1 (TC >=25%) analysis set included the subset of participants in the FAS whose PD-L1 status was PD-L1 (TC >=25%) as defined by the Ventana PD-L1 (SP263) assay (ie, >=25% TC expressing PD-L1 on the membrane).|||percentage of participants||95% Confidence Interval|Number
2576237|NCT02453282|Secondary|DoR; FAS Population|The DoR per RECIST 1.1 using BICR assessments was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).|Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).|The FAS included all randomized participants analyzed on an ITT basis. DoR is only analyzed for those participants with a response (including unconfirmed responses).|||months||Inter-Quartile Range|Median
2576238|NCT02453282|Secondary|DoR; PD-L1 (TC >=1%) Analysis Set Population|The DoR per RECIST 1.1 using BICR assessments was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).|Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).|The PD-L1 (TC >=1%) analysis set included the subset of participants in the FAS whose PD-L1 status is PD-L1 (TC >=1%) as defined by the Ventana PD-L1 (SP263) assay (ie, >=1% TC expressing PD-L1 on the membrane). DoR is only analyzed for those participants with a response (including unconfirmed responses).|||months||Inter-Quartile Range|Median
2576239|NCT02453282|Secondary|Duration of Response (DoR); PD-L1 (TC >=25%) Analysis Set Population|The DoR per RECIST 1.1 using BICR assessments was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).|Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).|The PD-L1 (TC >=25%) analysis set included the subset of participants in the FAS whose PD-L1 status was PD-L1 (TC >=25%) as defined by the Ventana PD-L1 (SP263) assay (ie,>=25% TC expressing PD-L1 on the membrane). DoR is only analyzed for those participants with a response (including unconfirmed responses).|||months||Inter-Quartile Range|Median
2576240|NCT02453282|Secondary|ORR; FAS Population|The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of CR or PR. The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).|Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).|The FAS included all randomized participants analyzed on an ITT basis.|||percentage of participants|||Number
2576241|NCT02453282|Secondary|ORR; PD-L1 (TC >=1%) Analysis Set Population|The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of CR or PR. The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).|Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).|The PD-L1 (TC >=1%) analysis set included the subset of participants in the FAS whose PD-L1 status is PD-L1 (TC >=1%) as defined by the Ventana PD-L1 (SP263) assay (ie, >=1% TC expressing PD-L1 on the membrane).|||percentage of participants|||Number
2576242|NCT02453282|Secondary|Objective Response Rate (ORR); PD-L1 (TC >=25%) Analysis Set Population|The ORR per RECIST 1.1 using BICR assessments was defined as the percentage of participants with at least 1 visit response of Complete Response (CR) or Partial Response (PR). The CR was defined as disappearance of all TLs (any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters as long as criteria for PD are not met).|Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).|The PD-L1 (TC >=25%) analysis set included the subset of participants in the FAS whose PD-L1 status was PD-L1 (TC >=25%) as defined by the Ventana PD-L1 (SP263) assay (ie, >=25% TC expressing PD-L1 on the membrane).|||percentage of participants|||Number
2576243|NCT02453282|Secondary|PFS; FAS Population|The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.|Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).|The FAS included all randomized participants analyzed on an ITT basis.|||months||95% Confidence Interval|Median
2576244|NCT02453282|Secondary|PFS; PD-L1 (TC >=1%) Analysis Set Population|The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.|Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).|The PD-L1 (TC >=1%) analysis set included the subset of participants in the FAS whose PD-L1 status is PD-L1 (TC >=1%) as defined by the Ventana PD-L1 (SP263) assay (ie, >=1% TC expressing PD-L1 on the membrane).|||months||95% Confidence Interval|Median
2576245|NCT02453282|Secondary|PFS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs Durvalumab Monotherapy|The PFS per RECIST 1.1 using BICR assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). The PD was defined as at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.|Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).|The PD-L1 (TC >=25%) analysis set included subset of participants in the FAS whose PD-L1 status was PD-L1 (TC >=25%) as defined by Ventana PD-L1 (SP263) assay (ie, >=25% TCs expressing PD-L1 on the membrane). Comparison of durvalumab + tremelimumab Vs durvalumab and durvalumab Vs SoC reporting groups were analysed for secondary outcome measure.|||months||95% Confidence Interval|Median
2576246|NCT02453282|Secondary|OS; FAS Population|The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.|From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).|The FAS included all randomized participants analyzed on an ITT basis.|||months||95% Confidence Interval|Median
2576811|NCT02447081|Primary|Number of Participants With Late Serious Adverse Events Greater Than 7 Days Post Procedure|Late adverse events were defined as those serious events with an onset date > 7 days post-procedure|7 days through 2 years||||Participants|||Count of Participants
2576247|NCT02453282|Secondary|OS; PD-L1 (TC >=1%) Analysis Set Population|The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.|From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).|The PD-L1 (TC >=1%) analysis set included the subset of participants in the FAS whose PD-L1 status is PD-L1 (TC >=1%) as defined by the Ventana PD-L1 (SP263) assay (ie, >=1% TC expressing PD-L1 on the membrane).|||months||95% Confidence Interval|Median
2576248|NCT02453282|Secondary|OS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs Durvalumab Monotherapy|The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.|From baseline until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).|The PD-L1 (TC >=25%) analysis set included the subset of participants in the FAS whose PD-L1 status was PD-L1 (TC >=25%) as defined by the Ventana PD-L1 (SP263) assay (ie, >=25% TCs expressing PD-L1 on the membrane). Comparison of durvalumab + tremelimumab Vs durvalumab monotherapy reporting groups were analysed for the secondary outcome measure.|||months||95% Confidence Interval|Median
2576249|NCT02453282|Primary|Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy|The PFS per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) using blinded independent central review (BICR) assessments was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdraw from randomized therapy or received another anti-cancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of at least 5 millimeter (mm), taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.|Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).|The PD-L1 (TC >=25%) analysis set included the subset of participants in the FAS whose PD-L1 status was PD-L1 (TC >=25%) as defined by the Ventana PD-L1 (SP263) assay (ie, >=25% TCs expressing PD-L1 on the membrane). Comparison of durvalumab + tremelimumab Vs SoC chemotherapy reporting groups were analysed for the primary outcome measure.|||months||95% Confidence Interval|Median
2576250|NCT02453282|Primary|Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy|The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.|From baseline (Day 1, Week 0) until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).|The PD-L1 (TC >=25%) analysis set included subset of participants in the FAS whose PD-L1 status was PD-L1 (TC >=25%) as defined by Ventana PD-L1 (SP263) assay (ie, >=25% TCs expressing PD-L1 on the membrane). Comparison of durvalumab monotherapy Vs SoC and durvalumab + tremelimumab Vs SoC reporting groups were analysed for primary outcome measure.|||months||95% Confidence Interval|Median
2576251|NCT02453256|Secondary|Serum Tocilizumab Concentration, Mean, Up to Week 96|Predose observed serum TCZ concentration at baseline and at specified timepoints thereafter|Up to Week 96|The PK population included all participants who received at least one TCZ injection and had at least one PK sample with detectable results. Only samples from the Double Blind TCZ, then Open Label TCZ were measured by the lab after week 48. Data for the Double Blind Period were reported at the time of Primary Results disclosure up to Week 48.|||ug/mL||Standard Deviation|Mean
2576252|NCT02453256|Secondary|Serum C-Reactive Protein (CRP) Level, Mean, Up to Week 96|Serum C-Reactive Protein (CRP) levels predose at baseline and at subsequent time points after initiation of study drug.|From Baseline up to Week 96|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||mg/L||Standard Deviation|Mean
2576253|NCT02453256|Secondary|Serum Soluble Interleukin (IL)-6 Receptor Level, Mean, Up to Week 96|Serum Soluble Interleukin (IL)-6 receptor levels predose at baseline and at subsequent time points after initiation of study drug.|Up to Week 96|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||ng/mL||Standard Deviation|Mean
2576254|NCT02453256|Secondary|Serum Interleukin (IL)-6 Level, Mean, From Baseline to Week 96|Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug.|Up to Week 96|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||pg/mL||Standard Deviation|Mean
2576255|NCT02453256|Secondary|Erythrocyte Sedimentation Rate (ESR) Up to Week 96|Erythrocyte Sedimentation Rate (ESR) levels predose at baseline and at subsequent time points after initiation of study drug.|Up to Week 96|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||mm/hr||Standard Deviation|Mean
2576256|NCT02453256|Secondary|Percentage of Participants With Positive Anti-Tocilizumab Assay Post-Baseline From Week 48 to 96|Reported were the percentage of participants with post-baseline treatment-induced anti-TCZ antibodies. Positive samples underwent additional analyses: a neutralizing assay for the ability to inhibit the activity of TCZ and a test for anti -TCZ of the IgE isotype.|Open-label period from Week 48 to 96|Safety population: received at least one dose of study drug and provide data from at least one post dose safety assessment. Only samples from the Double Blind TCZ, then Open Label TCZ were measured by the lab after week 48. Data for the Double Blind Period were reported at the time of Primary Results disclosure up to Week 48.|||Percentage of Participants|||Number
2576259|NCT02453256|Secondary|Incidence and Severity of Adverse Events Up to Week 96|Adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) severity grade: 1 = mild, 2 = moderate, 3 = severe and/or requiring medical intervention but not life-threatening, 4 = life-threatening consequences, and 5 = death.|Up to Week 96|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Number of participants|||Number
2576260|NCT02453256|Secondary|Summary of Adverse Events Up to Week 96|Summary of key safety results including Adverse Events of Special Interest (AESI). All adverse events categorized according to MedDRA version 21.1. NMSC = Non-Melanoma Skin Cancer|Up to Week 96|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Percentage of participants|||Number
2576261|NCT02453256|Secondary|Change in Median Percent Predicted Forced Vital Capacity (ppFVC), at Low, Medium and High Serum Tocilizumab Exposure From Baseline to Week 48|In order to characterize exposure-efficacy relationships, ppFVC scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Percent||Full Range|Median
2576262|NCT02453256|Secondary|Change in Mean Percent Predicted Forced Vital Capacity (ppFVC), at Low, Medium and High Serum Tocilizumab Exposure From Baseline to Week 48|In order to characterize exposure-efficacy relationships, ppFVC scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Percent||Standard Deviation|Mean
2576263|NCT02453256|Secondary|Change in Median Modified Rodnan Skin Score (mRSS), at Low, Medium and High Serum Tocilizumab Exposure From Baseline to Week 48|In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Units on a scale||Full Range|Median
2576264|NCT02453256|Secondary|Change in Mean Modified Rodnan Skin Score (mRSS) at Low, Medium and High Serum Tocilizumab Exposure From Baseline to Week 48|In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Units on a scale||Standard Deviation|Mean
2576265|NCT02453256|Secondary|Correlation Between High Serum Tocilizumab Exposure and Median Modified Rodnan Skin Score (mRSS) From Baseline to Week 48|In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Units on a scale||Full Range|Median
2576266|NCT02453256|Secondary|Correlation Between High Serum Tocilizumab Exposure and Mean Modified Rodnan Skin Score (mRSS) From Baseline to Week 48|In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Units on a scale||Standard Deviation|Mean
2576267|NCT02453256|Secondary|Correlation Between Medium Serum Tocilizumab Exposure and Median Modified Rodnan Skin Score (mRSS) From Baseline to Week 48|In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Units on a scale||Full Range|Median
2576268|NCT02453256|Secondary|Correlation Between Medium Serum Tocilizumab Exposure and Mean Modified Rodnan Skin Score (mRSS) From Baseline to Week 48|In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Units on a scale||Standard Deviation|Mean
2576269|NCT02453256|Secondary|Correlation Between Low Serum Tocilizumab Exposure and Median Modified Rodnan Skin Score (mRSS) From Baseline to Week 48|In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Units on a scale||Full Range|Median
2576328|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
2576270|NCT02453256|Secondary|Correlation Between Low Serum Tocilizumab Exposure and Mean Modified Rodnan Skin Score (mRSS) From Baseline to Week 48|In order to characterize exposure-efficacy relationships, mRSS scores are summarized based on TCZ exposure tertiles (high, medium, and low exposures) in the active treatment group and compared to placebo patients. Low Exposure = 0-<41 ug/ml, Medium = 41-<=61.1 ug/ml, High = 61.1-<=145 ug/ml.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Units on a scale||Standard Deviation|Mean
2576271|NCT02453256|Secondary|Serum Tocilizumab Concentration, Median, From Baseline to Week 48|Predose observed serum TCZ concentration at baseline and at specified timepoints thereafter|From Baseline to Week 48|The PK population includes all patients who received at least one TCZ injection and had at least one PK sample with detectable results.|||ug/mL||Full Range|Median
2576272|NCT02453256|Secondary|Serum Tocilizumab Concentration, Mean, From Baseline to Week 48|Predose observed serum TCZ concentration at baseline and at specified timepoints thereafter|From Baseline to Week 48|The PK population includes all patients who received at least one TCZ injection and had at least one PK sample with detectable results.|||ug/mL||Standard Deviation|Mean
2576273|NCT02453256|Secondary|Serum C-Reactive Protein (CRP) Level, Median, From Baseline to Week 48|Serum C-Reactive Protein (CRP) levels predose at baseline and at subsequent time points after initiation of study drug.|From Baseline up to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||mg/L||Inter-Quartile Range|Median
2576274|NCT02453256|Secondary|Serum C-Reactive Protein (CRP) Level, Mean, From Baseline to Week 48|Serum C-Reactive Protein (CRP) levels predose at baseline and at subsequent time points after initiation of study drug.|From Baseline up to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||mg/L||Standard Deviation|Mean
2576275|NCT02453256|Secondary|Serum Soluble Interleukin (IL)-6 Receptor Level, Median Change From Baseline to Week 48|Serum soluble Interleukin (IL)-6 receptor levels predose at baseline and at subsequent time points after initiation of study drug.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||ng/mL||Full Range|Median
2576276|NCT02453256|Secondary|Serum Soluble Interleukin (IL)-6 Receptor Level, Mean Change From Baseline to Week 48|Serum soluble Interleukin (IL)-6 receptor levels predose at baseline and at subsequent time points after initiation of study drug.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||ng/mL||Standard Deviation|Mean
2576277|NCT02453256|Secondary|Serum Soluble Interleukin (IL)-6 Receptor Level, Median, From Baseline to Week 48|Serum soluble Interleukin (IL)-6 receptor levels predose at baseline and at subsequent time points after initiation of study drug.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||ng/mL||Full Range|Median
2576278|NCT02453256|Secondary|Serum Soluble Interleukin (IL)-6 Receptor Level, Mean, From Baseline to Week 48|Serum soluble Interleukin (IL)-6 receptor levels predose at baseline and at subsequent time points after initiation of study drug.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||ng/mL||Standard Deviation|Mean
2576279|NCT02453256|Secondary|Serum Interleukin (IL)-6 Level, Median Change From Baseline to Week 48|Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||pg/mL||Full Range|Median
2576280|NCT02453256|Secondary|Serum Interleukin (IL)-6 Level, Mean Change From Baseline to Week 48|Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||pg/mL||Standard Deviation|Mean
2576281|NCT02453256|Secondary|Serum Interleukin (IL)-6 Level, Median, From Baseline to Week 48|Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||pg/mL||Full Range|Median
2576282|NCT02453256|Secondary|Serum Interleukin (IL)-6 Level, Mean, From Baseline to Week 48|Serum Interleukin (IL)-6 levels predose at baseline and at subsequent time points after initiation of study drug.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||pg/mL||Standard Deviation|Mean
2576283|NCT02453256|Secondary|Erythrocyte Sedimentation Rate (ESR), Median, From Baseline to Week 48|Erythrocyte Sedimentation Rate (ESR) levels predose at baseline and at subsequent time points after initiation of study drug.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||mm/hr||Inter-Quartile Range|Median
2576284|NCT02453256|Secondary|Erythrocyte Sedimentation Rate (ESR), Mean, From Baseline to Week 48|Erythrocyte Sedimentation Rate (ESR) levels predose at baseline and at subsequent time points after initiation of study drug.|From Predose up to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||mm/hr||Standard Deviation|Mean
2576285|NCT02453256|Secondary|Correlation Between Anti-Tocilizumab Antibody Status and Outcome Measures Pertaining to the Efficacy, Safety, and Pharmacokinetics of Tocilizumab|Pre-specified analysis of the relationship between Anti-Tocilizumab Antibody status and safety, efficacy, and PK endpoints were not analyzed via subgroup analyses as there was only 1 patient with ADA-positive status.|Baseline; during Weeks 8, 16, 24, 36, 48, 96, and/or at treatment discontinuation (up to 96 weeks); and 8 weeks after treatment discontinuation (up to 104 weeks overall)||||Units on a scale||Full Range|Median
2576286|NCT02453256|Secondary|Percentage of Participants With Positive Anti-Tocilizumab Assay Post-Baseline up to Week 48|Incidence of anti-Tocilizumab antibodies during the study relative to the prevalence of anti-Tocilizumab antibodies at baseline. Samples that are positive for anti-TCZ in the screening assay will be further analyzed by a confirmation assay to confirm specificity. If the confirmation assay is positive, two additional tests will be performed: a neutralizing assay for the ability to inhibit the activity of TCZ and a test for anti -TCZ of the IgE isotype.|Double-blind period (up to Week 48)|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Percentage of Participants|||Number
2576287|NCT02453256|Secondary|Percentage of Participants With Positive Anti-Tocilizumab Assay Result at Baseline|Incidence of anti-Tocilizumab at baseline|Baseline|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Percentage of Participants|||Number
2576288|NCT02453256|Secondary|Percentage of Participants With Change in Digital Ulcer Count During Double-blind Period|A digital ulcer is defined as an ulcer at or distal to the MCP joint on either the dorsal or volar surface, with loss of surface epithelialization. This does not include fissures, cracks, or calcium extrusions from calcinosis cutis. The number of fingers (0−10) with digital ulcers and the number of digital (or finger) ulcers will be counted and recorded by the investigator.|From Baseline to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Percentage of participants|||Number
2576289|NCT02453256|Secondary|Incidence of Haematology and Hepatic Laboratory Parameters During Double-blind Period|A laboratory event occurred if the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade for a post-baseline laboratory measurement increased from baseline.|From Baseline up to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Number of Participants|||Number
2576290|NCT02453256|Secondary|Frequency of Serious Systemic Sclerosis (SSC) Related Complications During Double-blind Period|Adverse event terms coded using MedDRA 20.1. Includes only those serious events adjudicated as SSC-related complications by an independent external committee.|From Baseline up to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Number of Participants|||Number
2576291|NCT02453256|Secondary|Number of Participants With Adverse Events Leading to Death During Double-blind Period|Reason of death is coded using MedDRA 20.1|From Baseline up to Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Number of participants|||Number
2576292|NCT02453256|Secondary|Incidence and Severity of Adverse Events During Double-blind Period|Adverse events listed according to MedDRA version 20.1 preferred terms and severity grade.|From Baseline until Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Number of participants|||Number
2576293|NCT02453256|Secondary|Summary of Adverse Events During Double-blind Period|Summary of key safety results including Adverse Events of Special Interest (AESI). All adverse events categorized according to MedDRA version 20.1. NMSC = Non-Melanoma Skin Cancer|From Baseline until Week 48|The analysis was conducted in the safety population i.e. received at least one dose of study drug and provide data from at least one post dose safety assessment.|||Percentage of Participants|||Number
2576294|NCT02453256|Secondary|Time to Treatment Failure According to mRSS, FVC, or Protocol-Specified Event During Double-blind Period|Time to treatment failure is defined as the time from randomization to the time of death, decline in percent-predicted FVC > 10% relative to baseline, > 20% increase in mRSS and an increase in mRSS of equal to or more than 5 points, or occurrence of a predefined SSc-related complication as adjudicated by the Clinical Adjudication Committee (whichever occurs first) during the 48-week double-blind treatment period. The median TTF was not estimable and is not presented for either treatment arm because of the low number of patients with events at Week 48.|From Baseline to Week 48|The analysis was conducted in the Intent-to-treat (ITT) population, i.e. all patients who were randomized and received any study drug.|||months||95% Confidence Interval|Median
2576295|NCT02453256|Secondary|Change in Physician Global Assessment Score During Double-blind Period|"The Physician's Global Assessment is to be completed on the basis of examination and overall assessment of the patient. The physician's assessment of the patient's SSc status will be scored on a 100-mm horizontal visual analogue scale (VAS), ranging from 0 on the extreme left end of the scale indicating has no effect at all (symptom free), and 100 on the extreme right end indicating worst possible effect."|From Baseline to Week 48|The analysis was conducted in the Intent-to-treat (ITT) population, i.e. all patients who were randomized and received any study drug.|||mm||95% Confidence Interval|Least Squares Mean
2576296|NCT02453256|Secondary|Change in Patient Global Assessment Score During Double-blind Period|"The Patient's Global Assessment represents the patient's overall assessment of current SSc status on a 100-mm horizontal visual analogue scale (VAS), ranging from 0 on the extreme left end of the scale indicating has no effect at all (symptom free), and 100 on the extreme right end indicating worst possible effect."|From Baseline to Week 48|The analysis was conducted in the Intent-to-treat (ITT) population, i.e. all patients who were randomized and received any study drug.|||mm||95% Confidence Interval|Least Squares Mean
2576297|NCT02453256|Secondary|Change in Health Assessment Questionnaire Disability Index (HAQ-DI) Score During Double-blind Period|The Health Assessment Questionnaire Disability Index (HAQ-DI) consists of 20 questions referring to eight component sets consisting of dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each item is scored on a 4-point scale from 0 to 3: 0 = Without any difficulty; 1 = With some difficulty; 2 = With much difficulty; 3 = Unable to do. Overall score was computed as the sum of component set scores and divided by the number of component sets answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. The total score indicates the patient's self-assessed level of disability. This outcome measure represents the change in mean score from baseline. A negative change from baseline indicates improvement.|From Baseline to Week 48|The analysis was conducted in the Intent-to-treat (ITT) population, i.e. all patients who were randomized and received any study drug.|||Scores on a Scale||95% Confidence Interval|Least Squares Mean
2576298|NCT02453256|Secondary|Change in Forced Vital Capacity (FVC) During Double-blind Period|FVC is pulmonary function test and will be conducted as per the study Pulmonary Function Manual, which is based on the American Thoracic Society/European Respiratory Society (ATS/ERS) Consensus Statement. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Patients perform three to eight exhalations into a spirometer with the highest value recorded.|From Baseline to Week 48|The analysis was conducted in the Intent-to-treat (ITT) population, i.e. all patients who were randomized and received any study drug.|||Liters of air||95% Confidence Interval|Least Squares Mean
2576299|NCT02453256|Secondary|Change From Baseline in Percent Predicted FVC (ppFVC) During Double-blind Period|FVC is pulmonary function test and will be conducted as per the study Pulmonary Function Manual, which is based on the American Thoracic Society/European Respiratory Society (ATS/ERS) Consensus Statement. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Patients perform three to eight exhalations into a spirometer with the highest value recorded.|Baseline to week 48|The analysis was conducted in the Intent-to-treat (ITT) population, i.e. all patients who were randomized and received any study drug.|||Percent Predicted FVC||95% Confidence Interval|Median
2576300|NCT02453256|Secondary|Percentage of Participants With Greater Than or Equal to (>/=) 20%, 40%, or 60% Improvement in mRSS During Double-blind Period|The proportion of participants with threshold improvements in mRSS at Week 48 relative to baseline.|From Baseline to Week 48|The analysis was conducted in the Intent-to-treat (ITT) population, i.e. all patients who were randomized and received any study drug.|||Percentage of Participants||95% Confidence Interval|Number
2576301|NCT02453256|Primary|Change in Modified Rodnan Skin Score (mRSS) During Double-blind Period|The efficacy of TCZ vs placebo is evaluated in terms of in mean change in mRSS. Skin thickness will be assessed by palpation and rated using an mRSS that ranges from 0 (normal) to 3 (severe skin thickening) across 17 different body sites. The total score is the sum of the individual skin scores from all of these sites and ranges from 0 to 51 units.|From baseline to week 48|The analysis was conducted in the Intent-to-treat (ITT) population, i.e. all patients who were randomized and received any study drug.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2576302|NCT02453048|Secondary|The Proportion of Subjects That Have an Antibody Response to BPZE1 Vaccination|"To assess the number of immune responders and levels of Immunoglobulin G/Immunoglobulin A (IgG/IgA) antibodies to pertussis toxin (PT), filamentous haemagglutinin adhesin (FHA), Pertactin (PRN), and fimbriae 2/3 in serum and nasopharyngeal aspirate.~A positive antibody response after vaccination is defined as at least 100% increase from pre- to post-vaccination, to at least 4 times minimum level of detection (MLD) for PT, FHA, PRN, and fimbriae 2/3 in the post-vaccination sample. The 4 antigens described are the standard 4 antigens historically used to describe a serum immunological response to B. pertussis. The absolute serum antibody titers have not shown a correlation of protection in previous pertussis vaccine studies of the current acellular vaccine and there is no known serum antigen threshold of protection for pertussis.~Antibodies are measured before vaccination and at 4, 7, 11, 14, 21, 28 days, 6-months and 12-months post-vaccination."|6 months||||Participants|||Count of Participants
2576303|NCT02453048|Secondary|Proportion of Subjects With BPZE1 Colonization|To assess the proportion of subjects having positive colonization of the human respiratory tract by live attenuated B. pertussis strain BPZE1 per group at any time period measured at 4, 7, 11, 14, 21 and 28 days post vaccination.|28 days||||Participants|||Count of Participants
2576304|NCT02453048|Primary|The Primary Safety Endpoint is the Number and Percentage of Participants Per Dose Group and Randomized Allocation, With at Least One of the Following Adverse Events Between Day 0 and Day 28|"Percentage is based on subjects experiencing at least one of the following events:~Cough and spasmodic cough of grade 2 or higher~Other respiratory tract AE related or possibly related to vaccination of grade 3 or higher~Any other AE related or possibly related to vaccination of grade 3 or higher"|28 days|Arms (Placebo separated from randomized groups)|||Participants|||Count of Participants
2576305|NCT02452944|Secondary|Count the Number of Sub-divisions of Obturator Nerve at the Inguinal Crease|We checked the additional intramuscular twitching with at least 3 times more needling after block the anterior and posterior branches in both groups. And documented that twitching occurred in what kind of muscles.|up to 8 weeks||||participants|||Number
2576306|NCT02452944|Primary|Success Rate of Ultrasound-guided Obturator Nerve Block With US-IFI Group and US-NS Group|"We used only the nerve stimulator for confirming the success or fail of the ONB before the surgery, so we assumed that the US-NS group had complete ONB in all patients.~In US-IFI group, complete ONB was confirmed with nerve stimulator at the end of the procedure, and if the residual twitching remained, the case was considered to be a 'fail'."|up to 8 weeks||||participants|||Number
2576307|NCT02452892|Post-Hoc|Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at End of Week 1, Day 4|"The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).Negative affect scores can be obtained by adding up scores for items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20. The negative affect score can range from 10 to 50, with lower scores representing lower level of negative affect, or the extent to which the individual feels aversive mood states and general distress.~This analysis outcome approach took Incorrect Item #2 and imputed using worst possible value."|Day 4, Week 1|"Full analysis set, Week 1.Item #2 was incorrectly listed as Disinterested instead of Distressed.resulting in incorrect data for this item for the first 16 subjects. The PANAS data for the first 16 randomized subjects and in total 72 data points was identified and removed from the database. See stats analysis for further details."|||units on a scale||95% Confidence Interval|Least Squares Mean
2576329|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520-treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
2576588|NCT02449291|Secondary|Number of Participants With Complete Response 2-24 Hrs|Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) and no administration of anti-emetic rescue medication from 2 to 24 hours after administration of study medication.|2-24 hours after administration of study medication||||Participants|||Count of Participants
2576308|NCT02452892|Post-Hoc|Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at Day 4|"The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).Negative affect scores can be obtained by adding up scores for items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20. The negative affect score can range from 10 to 50, with lower scores representing lower level of negative affect, or the extent to which the individual feels aversive mood states and general distress.~This analysis outcome treated Incorrect Item #2 where Item #2 data was removed."|Day 4|"Full analysis set, Week 1.Item #2 was incorrectly listed as Disinterested instead of Distressed.resulting in incorrect data for this item for the first 16 subjects. The PANAS data for the first 16 randomized subjects and in total 72 data points was identified and removed from the database. See stats analysis for further details."|||units on a scale||95% Confidence Interval|Least Squares Mean
2576309|NCT02452892|Post-Hoc|Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at Day 4|"The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).Negative affect scores can be obtained by adding up scores for items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20. The negative affect score can range from 10 to 50, with lower scores representing lower level of negative affect, or the extent to which the individual feels aversive mood states and general distress.~This analysis outcome treated Item #2 as random missing data."|Day 4, Week 1|Full analysis set, Week 1.Item #2 was incorrectly listed as “Disinterested” instead of “Distressed”.resulting in incorrect data for this item for the first 16 subjects. The PANAS data for the first 16 randomized subjects and in total 72 data points was identified and removed from the database. See stats analysis for further details.|||units on a scale||95% Confidence Interval|Least Squares Mean
2576310|NCT02452892|Post-Hoc|Positive and Negative Affect Schedule (PANAS): Change From Baseline at Day 4 in Positive Score|The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Used as a psychometric scale, the PANAS can show relationships between positive and negative affect with personality stats and traits. Descriptors are used to define their meanings. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).To calculate the positive affect score, added scores on items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19. Scores can range from 10-50, which higher scores representing higher levels of positive affect, or the extent to which the individual feels enthusiastic, active and alert.|Day 4 Week 1|Full Analysis Set (Week 1).|||units on a scale||95% Confidence Interval|Least Squares Mean
2576311|NCT02452892|Post-Hoc|Montgomery-Asberg Depression Rating Scale (MADRS): Change From Week 1 Baseline (Day 1) to End of Week 1 (Day 4)|"The MADRS is a 10-item checklist designed to measure the overall severity of depressive symptoms in subjects with Major Depressive Disorder (MDD). Individual items are rated on a scale of 0 to 6 in which a score of 6 represents the most severe symptoms for each item assessed. The total score ranges from 0 to 60.~Remission of depression based on the MADRS is defined as a subject with a MADRS total score of ≤11 at endpoint. A responder on the MADRS is defined as a 50% or greater reduction from baseline in total MADRS score"|Day 4 Week 1|Full Analysis Set, Week1|||units on a scale||95% Confidence Interval|Least Squares Mean
2576312|NCT02452892|Secondary|Day 4 Responders: Persistence of Effect Based on Pre-specified HAM-D6 Total Score|"To determine the persistence of response to LFMS therapy during a four-week follow-up period in subjects who were responders at Day 4. Persistence of response was achieved if during Week 2 post baseline visits and follow-up visits subjects' 6-item Hamilton Rating Scale for Depression (HAM-D6) total scores were lower than or equal to 50% of the baseline ( Day1 Week1) scores. Non-responder imputation method was used where missing post-baseline dichotomous (yes or no) were imputed as non-responder. Logistic regression model used to compare treatment groups for each visit, where the model considers the treatment, age and gender as covariates."|Day 42|Subjects who were HAM-D6 Day 4 responders, defined as those subjects who achieved a 50% or greater decrease in their HAM-D6 total score compared to Baseline ( Day1, Wk 1).|||percentage of LFMS responders|||Number
2576313|NCT02452892|Secondary|Change From Day 4 in HAM-D6 Total Score at Day 11 for Week 1 Non-responders: Response to 120 Minutes LFMS|"Hamilton Rating Scales for Depression were designed to measure the severity of depressive symptoms in subjects with primary depressive illness. HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from Day 11: mean score at Week 2 Day 11 minus mean score at Day 4.~To determine if subjects with TRD who are non-responders to 0, 20 or 60 minutes of LFMS on Day 4 may respond to 120 minutes of LFMS at the end of Day 11.~Responders will be defined as those subjects who achieve a decrease in HAM-D6 total score of 50% or more compared to baseline (Day 1, Week 1). All other subjects will be deemed to be non-responders. Each patient's total score is his/her own reference for determining a decrease of 50% or more."|Day 11 (Week 2)|Only non-responders at end of Day 4 comprise this Wk 2 analysis . (Non-responders were defined as those who didn't reach a decrease in 6-item Hamilton Rating Scale for Depression (HAM-D6) total score of 50% compared to baseline Day 1, Week 1). 41 subjects entered Week 2: 1 subject withdrew consent on Day 8 and was not part of the Full Analysis Set.|||units on a scale||95% Confidence Interval|Least Squares Mean
2576330|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520-treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
2576403|NCT02451943|Secondary|Pharmacokinetics (PK) Clearance of Olaratumab Mean Parameter Estimate|The PK systemic clearance parameter estimates from the current analysis are listed together with the population PK model estimates.|Cycle 1- 9: Day 1 and 8, Predose, 5 minutes Post dose and then every other cycle and follow-up (30 Days)|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||Liter/hour (L/h)||95% Confidence Interval|Mean
2576812|NCT02447081|Primary|Number of Participants With Acute Serious Adverse Events|Acute adverse events were defined as those serious events with an onset date ≤ 7 days post-procedure|0 to 7 days post procedure||||Participants|||Count of Participants
2576314|NCT02452892|Primary|Change From Baseline to ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score.|"Hamilton Rating Scales for Depression were designed to measure the severity of depressive symptoms in subjects with primary depressive illness. HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline: mean score at Week 1 Day 4 minus mean score at baseline.~Week 1 Day 4 : Change from baseline to the end of the efficacy period ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) total score .Responders at Day 4 will be defined as those subjects who achieve a decrease in HAM-D6 total score of 50% or more compared to baseline (Day 1, Week 1). All other subjects will be deemed to be non-responders at Day 4. Each patient's total score is his/her own reference for determining a decrease of 50% or more."|Week 1 Day 4|Subjects in the All Randomized set who completed at least one treatment session and had at least one post baseline primary efficacy assessment.|||units on a scale||95% Confidence Interval|Least Squares Mean
2576315|NCT02452554|Other Pre-specified|CD56 Expression|The association between CD56+ expression and response will be evaluated using the exact conditional test of proportions (Fisher?s Exact test). Analyses will be descriptive and exploratory and hypotheses generating in nature.|Day 1 and 8 of course 1 prior to lorvotuzumab mertansine|||||||
2576316|NCT02452554|Other Pre-specified|Pharmacokinetic (PK) Parameters of Lorvotuzumab Mertansine|A descriptive analysis of PK parameters of lorvotuzumab mertansine will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters. The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit). Analyses will be descriptive and exploratory and hypotheses generating in nature.|Pre-treatment, end of infusion, and 2, 6, 24, 48, and 96 hours after end of infusion on day 1 of course 1, and pre-treatment, end of infusion, and 2 and 6 hours after end of infusion on day 8 of course 1|||||||
2576317|NCT02452554|Primary|Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0|Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade for toxicities with Possible, Probable, or Definite attribution to the study drug. Tables will summarize incidence by cycle.|Up to 12 months (17 courses)|203 treatment-cycles were reported for the analysis. 2 participants were excluded from analysis;1 participant never received treatment and 1 participant was ineligible, also never receiving treatment.|||Treatment cycles|Treatment Cycles||Number
2576318|NCT02452554|Primary|Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.1|The best response of disease will be examined separately in each stratum. A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and Clopper-Pearson confidence intervals will be constructed.|Up to 18 weeks (6 courses)|2 participants were excluded from analysis; 1 participant never received treatment and 1 participant was ineligible, also never receiving treatment.|||Percent of participants||95% Confidence Interval|Number
2576319|NCT02452528|Secondary|Pharmacokinetics of Entecavir or Tenofovir: Time of Cmax (Tmax)||Through 24 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
2576320|NCT02452528|Secondary|Pharmacokinetics of Entecavir or Tenofovir: Cmax||Through 24 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on subjects receiving ARC-520. At the time of study termination only 2 ARC-520 treated subjects had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
2576321|NCT02452528|Secondary|Pharmacokinetics of Entecavir or Tenofovir: AUClast||Through 24 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
2576322|NCT02452528|Secondary|Pharmacokinetics of Entecavir or Tenofovir: AUC0-24||Through 24 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
2576323|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Terminal Elimination Half-Life (t1/2)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
2576324|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Terminal Elimination Rate Constant (Kel)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
2576325|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Apparent Volume of Distribution (V)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
2576326|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Apparent Clearance (CL)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
2576327|NCT02452528|Secondary|Pharmacokinetics of ARC-520: Maximum Observed Plasma Concentration (Cmax)||Through 48 hours post-dosing on Days 1 and 57|Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.||||||
2576331|NCT02452528|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with treatment. An SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction. An AE was classified as a TEAE if the AE was not present prior to the first study medication administration and started at or after the time of initiation of administration of study medication, or if the AE presented prior to initiation of administration of study medication, continued and increased in intensity after administration of study medication.|From time of informed consent through Day 147 ± 3 days|All participants who received at least 1 dose of ARC-520 or placebo|||Participants|||Count of Participants
2576332|NCT02452528|Primary|Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 85||Baseline, Day 85|At the time of study termination only 2 ARC-520-treated and 2 placebo-treated participants had been enrolled. Due to the small sample size, analysis of this primary endpoint was not performed.||||||
2576333|NCT02452463|Secondary|Biomarker Analysis|The tethered cationic lipoplex nanoparticle biochip, microfluidic cationic lipoplex nanoparticle biochip and real-time quantitative reverse transcription-polymerase chain reaction measurements for the expression of micro ribonucleic acid -1, -21, -127 and -155 will be made. The micro ribonucleic acid expressions, vitamin D levels, and mitochondrial deoxyribonucleic acid levels will be treated as continuous and reported by radiation pneumonitis status using the mean, median and standard deviation. Comparisons will be made between groups using a two-sided permutation t-test.|Up to 97 days post-treatment|Due to early termination of the study, the biomarker data was never collected and analyzed.||||||
2576334|NCT02452463|Secondary|Responses Rates|"Complete response and complete/partial response rates will be reported by study arm and chemotherapy regimen using Wilson 95% confidence intervals. The responses rates will be compared between study arms using the Cochran-Mantel-Haenszel exact test.~The objective tumor response was assessed using RECIST 1.1:~Complete Response (CR): Disappearance of all target lesions. Any lymph nodes must have a reduction in short axis to < 10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions. The appearance of one or more new lesions is also considered progression.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameter while on study.~Overall response = CR + PR."|Up to 2.5 years post-treatment|Study was terminated prior to enrollment in Arm 3.|||Participants|||Count of Participants
2576335|NCT02452463|Secondary|Changes in Radiation Pneumonitis Scores|"Changes in radiation pneumonitis scores, relative to baseline, will be evaluated within each study arm using the Wilcoxon signed rank or paired t-tests, as appropriate. Changes in radiation pneumonitis scores may be compared between study arms using the Wilcoxon rank sum or independent sample t-tests, as appropriate.~The radiation pneumonitis scores were obtained using semi quantitative analysis will be performed for the presence of ground-glass opacity, consolidation, reticulation, mosaic perfusion, traction bronchiectasis and honeycombing for each lung zone and scored on a four point scale (0 = no involvement, 1 ≤ 25%; 2 = 26 50%; 3 = 51 75% and 4 ≥ 76%). The scores are averaged across two radiologists."|Baseline up to 2.5 years post-treatment|Study was terminated prior to enrollment in Arm 3. For Arms 1 and 2, not all follow-up tests were completed.|||score on a scale||Standard Deviation|Mean
2576336|NCT02452463|Secondary|Percent Change in Pulmonary Function Tests|Percent change in pulmonary function test, relative to baseline, will be evaluated within each study arm using the Wilcoxon signed rank or paired t-tests, as appropriate. Changes in pulmonary function tests may be compared between study arms using the Wilcoxon rank sum or independent sample t-tests, as appropriate.|Baseline up to 2.5 years post-treatment|Study was terminated prior to enrollment in Arm 3. For Arms 1 and 2, not all follow-up tests were completed.|||percent of change||Standard Deviation|Mean
2576337|NCT02452463|Secondary|Percent Changes in Overall Quality of Life and Symptom Scores|"Percent changes in the quality of life and symptom scores may be compared between study arms using the Wilcoxon rank sum or independent sample t-tests, as appropriate.~The quality of life scores are obtained using the Lung Cancer Symptom Scale (LCSS) The scores range from 0 to 68, where 0 indicates poor quality of life and 68 indicates good quality of life. The percent change from baseline was calculated as 100*(post treatment - baseline) / baseline."|Baseline up to 2.5 years post-treatment|Study was terminated prior to enrollment in Arm 3. For Arms 1 and 2, not all follow-up tests were completed.|||percent change||Standard Deviation|Mean
2576338|NCT02452463|Secondary|Progression-free Survival|Progression-free survival will be reported using standard Kaplan-Meier methods. Comparisons of progression-free survival between study arms may utilize the two-sided stratified log-rank test.|1 year progression-free survival, with follow-up assessed up to 2.5 years post-treatment|Study was terminated prior to enrollment in Arm 3.|||Percent survival at 1 year||95% Confidence Interval|Number
2576339|NCT02452463|Secondary|Overall Survival|Overall survival will be reported using standard Kaplan-Meier methods. Comparisons of overall survival between study arms may utilize the two-sided stratified log-rank test.|1 year survival, with follow-up assessed up to 2.5 years post-treatment|Study was terminated prior to enrollment in Arm 3.|||Percent survival at 1 year||95% Confidence Interval|Number
2576340|NCT02452463|Secondary|Number of Participants With Adverse Events, Graded According to Common Terminology Criteria for Adverse Events Version 4.0|The frequency of toxicities will be tabulated by grade.|Up to 2.5 years post-treatment|Study was discontinued prior to subjects being enrolled in Arm III|||Participants|||Count of Participants
2576341|NCT02452463|Primary|Portion of Common Terminology Criteria for Adverse Events Grade 2 or Higher Radiation Pneumonitis|"Will compare the rate of symptomatic radiation pneumonitis in patients who received nintedanib versus placebo. Assessed using the intent-to-treat principle and a one-sided exact test about the Cochran-Mantel-Haenszel correlation and regression test.~The grade 2 or higher radiation penumonitis is identified by the Common Terminology Criteria for Adverse Events."|At 6 months after completion of chemoradiation|Study was terminated prior to enrollment in Arm 3.|||proportion of participants|||Number
2579899|NCT02412501|Secondary|Number of Participants With Cardiac Death at 24 Months Post Procedure||24 Months||||Participants|||Count of Participants
2576342|NCT02452424|Secondary|Summary of the Percentage of Participants With Objective Response Rate Assessed by RECIST v1.1 During Pembrolizumab and PLX3397|Objective response rate was defined as the proportion of subjects who achieved a best disease response of either Complete or Partial (CR or PR) based on the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed generally by MRI, CT, or PET-CT and are summarized as: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Participants who discontinued study therapy due to clinical progression, radiographic progression, or death without the required tumor assessments were considered to be non-responders in the Objective Response Rate (ORR) calculation. The efficacy analysis included all subjects with baseline tumor measurements who received at least 1 dose of study drug.|1 year (Dose Escalation); 2 years (Dose Expansion)|Overall best response was assessed in the Efficacy Analysis Set.|||Participants|||Count of Participants
2576343|NCT02452424|Primary|Treatment-emergent Adverse Events (TEAEs) in Participants Regardless of Causality While Taking PLX3397 in Combination With Pembrolizumab|Treatment-emergent Adverse Events (TEAEs) in participants regardless of causality while taking PLX3397 in combination with pembrolizumab are reported|1 year (Dose Escalation); 2 years (Dose Expansion)|Safety events were assessed in the Safety Population.|||Participants|||Count of Participants
2576344|NCT02452346|Secondary|One Year and Two Year Survival||from start of treatment to 1 year and 2 years post treatment initiation||||Participants|||Count of Participants
2576345|NCT02452346|Secondary|Overall Response|Overall response according to IWG 2006 criteira|Approximately 3 years||||Participants|||Count of Participants
2576346|NCT02452346|Primary|Over All Survival|Survival following treatment to the date of death, assessed up to a period of 3-4 years.|from start of treatment until death, assessed up to a period of 3-4 years.||||months||Full Range|Median
2576347|NCT02452320|Secondary|Hospital Costs|Accessing billing codes/hospital costs for each enrolled subject from the time they are admitted until they are discharged from the hospital.|Costs incurred during hospital stay, expected average of 3 days.|Used the Hospital cost data for the subjects enrolled in both arms of the study for the duration of their hospitalization.|||Dollars (USD)||Inter-Quartile Range|Median
2576348|NCT02452320|Secondary|Length of Hospital Stay|Monitoring the length of hospital stay after undergoing surgery|Participants will be followed for the duration of hospital stay, expected average of 3 days.|Subjects LoS were recorded from time of PACU admission till time that Discharge Orders were completed.|||days||Inter-Quartile Range|Median
2576349|NCT02452320|Primary|Quality of Recovery-15 Patient Survey|Survey asking 15 questions with regard to how the patient is feeling scored on a scale from 0-10, with 0 being none of the time and 10 being all of the time. Possible scores range from 0-150, and scores with a higher value indicate a better outcome. Each subject was administered a baselineQoR-15 survey prior to surgery, and then one on postoperative days (POD) 1 and 2. If a subject was discharged prior to POD2, they were not given a QoR-15 survey that day.|Patients will be followed for the duration of hospital stay, expected average of 3 days.|Subjects were administered a QoR-15 Survey pre-operatively as a baseline, and on post-operative days 1 and 2. Some subjects were discharged prior to the administration of the QoR-15 on post-operative day 2 and therefore there is no data for those subjects that we no longer in the hospital.|||units on a scale||Standard Deviation|Mean
2576350|NCT02452190|Secondary|Number of Moderate Exacerbations During 52 Weeks of Treatment|A moderate exacerbation was defined as a clinically judged deterioration in asthma control as determined by investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention requiring additional asthma controller medication that was not a systemic corticosteroid and did not result in an asthma-specific hospitalization or emergency department visit (that is, a medical intervention that did not otherwise meet the criteria for primary endpoint). Frequency of moderate exacerbations over 52-week treatment period is expressed as adjusted exacerbation rate in 52 weeks. Adjusted exacerbation rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors (age group, blood eosinophil group) and number of prior exacerbations, and an offset variable.|Day 1 to Week 52|ITT population includes all randomized participants, excluding participants from the site terminated due to GCP issues. Treatment was based on the treatment to which participants were randomized, regardless of which treatment they received.|||events||95% Confidence Interval|Mean
2576351|NCT02452190|Secondary|Number of CAEs Requiring Hospitalization and/or Emergency Department Visits During 52 Weeks of Treatment|A CAE was defined as a clinically judged deterioration in asthma control, as determined by the investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention, including at least 1 of the following: 1) use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral corticosteroid dose for at least 3 days; 2) asthma-specific hospital admission; 3) asthma-specific emergency department visit. The frequency of CAEs over 52-week treatment period is expressed as adjusted CAEs rate in 52 weeks. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors (age group, blood eosinophil group) and number of prior exacerbations, and an offset variable.|Day 1 to Week 52|ITT population includes all randomized participants, excluding participants from the site terminated due to GCP issues. Treatment was based on the treatment to which participants were randomized, regardless of which treatment they received.|||events||95% Confidence Interval|Mean
2576376|NCT02452047|Secondary|Percentage of cUTI Participants With Favorable Microbiological Response (FMR) at OTX|"The percentage of participants with FMR at OTX was determined for participants with cUTI in Groups 1 and 2. FMR was defined as urine culture results at OTX showing eradication (i.e., ≥10^5 colony forming units [CFU]/mL at baseline was reduced to <10^4 CFU/mL at OTX) of the uropathogen."|OTX (Day 3)|Participants in Group 1 and Group 2 with cUTI who received ≥1 dose of each trial drug within a given IV treatment regimen, and who had a baseline bacterial pathogen that met inclusion criteria, are included. As per protocol, efficacy data from open-label Group 3 was considered exploratory and not included in the comparative analysis.|||Percentage of Participants||95% Confidence Interval|Number
2579900|NCT02412501|Secondary|Number of Participants With Stent Thrombosis (ST) at 12 Months Post Procedure||12 Months||||Participants|||Count of Participants
2576352|NCT02452190|Secondary|Kaplan-Meier (K-M) Estimate of Probability (Percent [%]) of Not Experiencing a CAE by Week 52|"CAE was defined as a clinically judged deterioration in asthma control, as determined by the investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention, including at least 1 of the following: 1) use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral corticosteroid dose for at least 3 days; 2) asthma-specific hospital admission; 3) asthma-specific emergency department visit.~The KM method was used to estimate and compare the distributions of time to first CAE between treatment groups. Participants without an event during the treatment period were censored at either the date of the end of treatment (Week 52) visit for participants who completed treatment or at the date of last dose (+4 weeks) for participants who discontinued early."|Day 1 to Week 52|ITT population includes all randomized participants, excluding participants from the site terminated due to GCP issues. Treatment was based on the treatment to which participants were randomized, regardless of which treatment they received.|||percent probability||95% Confidence Interval|Number
2576353|NCT02452190|Secondary|Change From Baseline to Week 32 in St. George's Respiratory Questionnaire (SGRQ) Total Score|The SGRQ is a 17-item questionnaire with 50 weighted responses. It provides a total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The total score and each of the SGRQ subscores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. Analysis of the change from baseline to each visit was performed using a mixed effect model for repeated measures (MMRM) including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.|Baseline, Week 32|ITT population includes all randomized participants, excluding participants from site terminated due to GCP issues. Treatment was based on treatment to which participants were randomized, regardless of which treatment they received. Overall number of participants analyzed= participants with both baseline and Week 32 SGRQ total scores available.|||units on a scale||Standard Error|Least Squares Mean
2576354|NCT02452190|Secondary|Percentage of Asthma Control Days|The percentage of asthma control days over 52 weeks of treatment is presented. An asthma control day was defined as a day on which the participant used less than or equal to 2 puffs of inhaled short-acting beta-agonist, had no nighttime awakenings, and experienced no asthma exacerbations. Analysis of the change from baseline to each visit was performed using a mixed effect MMRM including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.|Day 1 to Week 52|ITT population includes all randomized participants, excluding participants from the site terminated due to GCP issues. Treatment was based on the treatment to which participants were randomized, regardless of which treatment they actually received.|||percentage of days||Standard Error|Least Squares Mean
2576355|NCT02452190|Secondary|Change From Baseline to Week 52 in Total Asthma Symptom Scores (Day and Night)|Asthma symptoms were recorded by participant each day and night in an asthma control diary. Night score was assessed on a 5-point scale where 0=no symptoms, slept through night, to 4=bad night, no sleep. Day score was assessed on a 6-point scale where 0=very well, no symptoms, to 5= asthma very severe, unable to carry out daily activities. Total asthma symptom score was calculated by taking the sum of the night and day asthma symptom scores recorded, ranging from 0 (no symptom) to 9 (severe symptom). A lower symptom score indicated a better outcome. Analysis of the change from baseline to each visit was performed using a MMRM including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.|Baseline, Week 52|ITT population included all randomized participants, excluding participants from site terminated due to GCP issues. Treatment was based on treatment to which participants were randomized, regardless of which treatment they received. Overall number of participants analyzed=participants with both baseline and Week 52 total asthma symptom score.|||units on a scale||Standard Error|Least Squares Mean
2576356|NCT02452190|Secondary|Change From Baseline to Week 52 in 6-item Asthma Control Questionnaire (ACQ-6) Score|The ACQ-6 is a 6-item validated asthma assessment tool that has been widely used. Six questions are self-assessments (completed by the participant), 5 questions assessing asthma symptoms: night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and 1 question for short-acting bronchodilator use. Each item on the ACQ-6 has a possible score ranges from 0 to 6, and the total score is the mean of all responses. The total score ranging from 0-6 (0=totally controlled and 6=severely uncontrolled). A higher score indicated poorer asthma control. Analysis of the change from baseline to each visit was performed using a mixed effect model for repeated measures (MMRM) including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect.|Baseline, Week 52|ITT population includes all randomized participants, excluding those from the site terminated due to GCP issues. Treatment was based on the treatment to which participants were randomized, regardless of which treatment they received. Overall number of participants analyzed=participants with both baseline and Week 52 ACQ-6 score available.|||units on a scale||Standard Error|Least Squares Mean
2576357|NCT02452190|Secondary|Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for Participants 12 Years and Older (AQLQ+12) Score|"AQLQ is a 32-item instrument administered as a self-assessment. AQLQ+12 is a modified version of AQLQ developed to measure functional impairments of participants aged 12-70 years. It is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Participants were asked to recall their experiences during the last 2 weeks and respond to each question on a 7-point scale (1=severe impairment, 7=no impairment), where higher scores indicated better quality of life. Overall AQLQ+12 score is the mean of all 32 responses. Analysis of the change from baseline to each visit was performed using a MMRM including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect."|Baseline, Week 52|Participants of the ITT population aged 12 to 70 years. Overall number of participants analyzed=participants with both baseline and Week 52 AQLQ+12 score available.|||units on a scale||Standard Error|Least Squares Mean
2576358|NCT02452190|Secondary|Change From Baseline to Week 52 in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|"Change in pre-bronchodilator FEV1 from baseline to week 52 is presented. FEV1 is a standard measurement of air movement in the lungs of participants with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer.~Analysis of the change from baseline to each visit was performed using a mixed effect model for repeated measures (MMRM) including fixed effects for treatment, visit, treatment by visit interaction, age group, blood eosinophil counts at enrollment, and sex, height and baseline value as covariates, and participant as a random effect."|Baseline, Week 52|ITT includes all randomized participants, excluding participants from the site terminated due to GCP issues. Treatment was based on the treatment to which participants were randomized, regardless of which treatment they received. Overall number of participants analyzed=participants with both baseline and Week 52 FEV1 values available.|||liters||Standard Error|Least Squares Mean
2576359|NCT02452190|Primary|Number of Clinical Asthma Exacerbations (CAEs) During 52 Weeks of Treatment|A CAE was defined as a clinically-judged deterioration in asthma control, as determined by the investigator and as evidenced by new or worsening asthma signs or symptoms based on the participant's history, asthma control diary, physical examination, and/or ambulatory or clinic visit assessment of lung function and that resulted in a medical intervention, including at least 1 of the following: 1) use of systemic corticosteroids (oral or injection) or at least a doubling from a stable maintenance oral corticosteroid dose for at least 3 days; 2) asthma-specific hospital admission; 3) asthma-specific emergency department visit. Adjusted CAE rate and confidence intervals were based on Negative Binomial regression model adjusted for stratification factors. Results are presented as adjusted means. For this analysis, the offset variable is calculated as the logarithm of treatment duration minus the summed duration of exacerbations during the treatment period.|Day 1 to Week 52|ITT population included all randomized participants, excluding participants from the site terminated due to GCP issues. Treatment was based on the treatment to which participants were randomized, regardless of which treatment they received.|||events||95% Confidence Interval|Mean
2576360|NCT02452060|Other Pre-specified|Change in Serum Level of BDNF After Ketamine Infusion|changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.|1 day|||||||
2576361|NCT02452060|Other Pre-specified|Change in Serum Level of TNF-α After Ketamine Infusion|changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.|1 day|||||||
2576362|NCT02452060|Other Pre-specified|Change in Serum Level of IL-6 After Ketamine Infusion|changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.|1 day|||||||
2576363|NCT02452060|Other Pre-specified|Survey Scores - MADRS|Change in scores for MADRS|Pre-op,Day of Surgery through Post-op Day 8|||||||
2576364|NCT02452060|Other Pre-specified|Survey Scores - QoR15|Change in scores for Quality of Recovery 15 - QoR15|Pre-op,Day of Surgery through Post-op Day 8|||||||
2576365|NCT02452060|Other Pre-specified|Survey Scores - Becks Depression Index (BDI)|Change in survey scores for Becks Depression Index (BDI)|Pre-op,Day of Surgery through Post-op Day 8|||||||
2576366|NCT02452060|Other Pre-specified|Survey Scores - McGill's Short Form|Change in survey scores -- McGill's short form|Pre-op,Day of Surgery through Post-op Day 8|||||||
2576367|NCT02452060|Other Pre-specified|Change in Serum Level of IL-1 After Ketamine Infusion|changes in serum levels of IL-1, which will be collected at baseline (in the OR preoperatively), and 15 min and 4 hours after the termination of ketamine infusion.|1 day|||||||
2576368|NCT02452060|Other Pre-specified|Spirometry Use 4 Hours After the Termination of Ketamine Infusion|Spirometry use will be assessed by a study team member to determine whether the patient is meeting the goal set by the surgical team 4 hours after ketamine infusion.|1 day|||||||
2576369|NCT02452060|Other Pre-specified|Time to Out of Bed to Chair (OOB)|Patient will be asked to record and report the time to OOB|7 Days|||||||
2576370|NCT02452060|Other Pre-specified|Opioid Usage Per Day Throughout the Hospital Stay|recorded from medical chart|8 days|||||||
2576371|NCT02452060|Other Pre-specified|Opioid Usage Per Hour During the PACU Stay Before and After Ketamine Infusion|Length of stay and opioid usage will be recorded from electronic medical chart|8 Days|||||||
2576372|NCT02452060|Secondary|Length of Stay During Hospitalization|LOS will be recorded from medical record.|8 days||||Days||Inter-Quartile Range|Median
2576373|NCT02452060|Primary|Change in Pain Scores|VAS Scores will be assessed on Day of Surgery (DOS), Post-op Day (POD) 1, 2 and 7. If patients have been discharged, coordinators will contact patient by home.|Baseline (DOS) to 7 days (Post Op)||||score on a scale||Standard Deviation|Mean
2576374|NCT02452047|Secondary|Percentage of cUTI Participants With FMR at EFU|"The percentage of participants with FMR at EFU was determined for participants with cUTI in Groups 1 and 2. FMR was defined as urine culture results at EFU showing sustained eradication (i.e., ≥10^5 CFU/mL at baseline that was reduced to <10^4 CFU/mL previously remained <10^4 CFU/mL at EFU) of the uropathogen."|EFU (Between Day 10 and Day 30 [5 to 9 Days after EOT])|Participants in Group 1 and Group 2 with cUTI who received ≥1 dose of each trial drug within a given IV treatment regimen, and who had a baseline bacterial pathogen that met inclusion criteria, are included. As per protocol, efficacy data from open-label Group 3 was considered exploratory and not included in the comparative analysis.|||Percentage of Participants||95% Confidence Interval|Number
2576375|NCT02452047|Secondary|Percentage of cUTI Participants With FMR at EOT|"The percentage of participants with FMR at EOT was determined for participants with cUTI in Groups 1 and 2. FMR was defined as urine culture results at EOT showing eradication (i.e., ≥10^5 CFU/mL at baseline was reduced to <10^4 CFU/mL at EOT) or sustained eradication (i.e., ≥10^5 CFU/mL at baseline that was reduced to <10^4 CFU/mL previously remained <10^4 CFU/mL at EOT) of the uropathogen."|At EOT (up to Day 21)|Participants in Group 1 and Group 2 with cUTI who received ≥1 dose of each trial drug within a given IV treatment regimen, and who had a baseline bacterial pathogen that met inclusion criteria, are included. As per protocol, efficacy data from open-label Group 3 was considered exploratory and not included in the comparative analysis.|||Percentage of Participants||95% Confidence Interval|Number
2579901|NCT02412501|Secondary|Number of Participants With Target Vessel Failure (TVF) at 12 Months Post Procedure||12 Months||||Participants|||Count of Participants
2576377|NCT02452047|Secondary|Percentage of Participants With FCR at EFU|"The percentage of participants with FCR at EFU was determined for Groups 1 and 2. FCR at EFU was defined as sustained cure or cure. Sustained cure (for participants with cure response at the prior visit) was defined as all pretherapy signs and symptoms of index infection resolved with no evidence of resurgence and no additional antibiotic therapy required, and (for cIAI participants) no unplanned surgical procedures or percutaneous drainage procedures have been performed. Cure (for participants with improved response at EOT visit) was defined as all pretherapy signs and symptoms of index infection resolved or returned to preinfection status, and no additional IV antibiotic therapy required, and (for cIAI participants) no unplanned surgical procedures or percutaneous drainage procedures performed."|EFU (Between Day 10 and Day 30 [5 to 9 Days after EOT])|Participants in Group 1 and Group 2 who received ≥1 dose of each trial drug within a given IV treatment regimen, and who had a baseline bacterial pathogen that met inclusion criteria, are included. As per protocol, efficacy data from open-label Group 3 was considered exploratory and not included in the comparative analysis.|||Percentage of Participants||95% Confidence Interval|Number
2576378|NCT02452047|Secondary|Percentage of Participants With FCR at End of Therapy (EOT)|"The percentage of participants with FCR at EOT was determined for Groups 1 and 2. FCR at EOT was defined as cure or improved. Cure was defined as all pretherapy signs and symptoms of index infection resolved or returned to preinfection status, and no additional IV antibiotic therapy required, and (for cIAI participants) no unplanned surgical procedures or percutaneous drainage procedures performed. Improved was defined as all or most pretherapy signs and symptoms of index infection have improved or resolved, and (for cIAI participants) no unplanned surgical procedures or percutaneous drainage procedures have been performed."|At EOT (up to Day 21)|Participants in Group 1 and Group 2 who received ≥1 dose of each trial drug within a given IV treatment regimen, and who had a baseline bacterial pathogen that met inclusion criteria, are included. As per protocol, efficacy data from open-label Group 3 was considered exploratory and not included in the comparative analysis.|||Percentage of Participants||95% Confidence Interval|Number
2576379|NCT02452047|Secondary|Percentage of Participants With FCR on Therapy (OTX)|"The percentage of participants with a FCR at OTX was determined for Groups 1 and 2. FCR at OTX was defined as improved. Improved was defined as all or most pretherapy signs and symptoms of index infection have improved or resolved, and (for cIAI participants) no unplanned surgical procedures or percutaneous drainage procedures have been performed."|OTX (Day 3)|Participants in Group 1 and Group 2 who received ≥1 dose of each trial drug within a given IV treatment regimen, and who had a baseline bacterial pathogen that met inclusion criteria, are included. As per protocol, efficacy data from open-label Group 3 was considered exploratory and not included in the comparative analysis.|||Percentage of Participants||95% Confidence Interval|Number
2576380|NCT02452047|Secondary|Percentage of Participants With All-cause Mortality Up to Day 28|The percentage of participants with all-cause mortality up to Day 28 was determined for Groups 1 and 2.|Up to Day 28|Participants in Group 1 and Group 2 who received ≥1 dose of each trial drug within a given IV treatment regimen, and who had a baseline bacterial pathogen that met inclusion criteria, are included. As per protocol, efficacy data from open-label Group 3 was considered exploratory and not included in the comparative analysis.|||Percentage of Participants||95% Confidence Interval|Number
2576381|NCT02452047|Secondary|Percentage of Participants With Favorable Clinical Response (FCR) at Day 28|"The percentage of participants with FCR at Day 28 was determined for Groups 1 and 2. FCR at Day 28 was defined as sustained cure or cure. Sustained cure (for participants with cure response at the prior visit) was defined as all pretherapy signs and symptoms of index infection resolved with no evidence of resurgence and no additional antibiotic therapy required, and (for cIAI participants) no unplanned surgical procedures or percutaneous drainage procedures have been performed. Cure (for participants with improved response at EOT visit) was defined as all pretherapy signs and symptoms of index infection resolved or returned to preinfection status, and no additional IV antibiotic therapy required, and (for cIAI participants) no unplanned surgical procedures or percutaneous drainage procedures performed."|Day 28|Participants in Groups 1 and 2 who received ≥1 dose of each trial drug within a given IV treatment regimen, and who had a baseline bacterial pathogen that met inclusion criteria, are included. As per protocol, efficacy data from open-label Group 3 was considered exploratory and not included in the comparative analysis.|||Percentage of Participants||95% Confidence Interval|Number
2576382|NCT02452047|Secondary|Percentage of Participants With ≥1 Events of Treatment-Emergent Nephrotoxicity|"Treatment-emergent nephrotoxity was assessed in Groups 1 and 2 as indicated by the protocol (Group 3 was not included). Nephrotoxicity for participants with normal baseline serum creatinine levels (<1.2 mg/dL) was defined as doubling of serum creatinine to >1.2 mg/dL or reduction in creatinine clearance (ClCR) of ≥50%. Nephrotoxicity for participants with pre-existing renal dysfunction (baseline serum creatinine level ≥1.2 mg/dL) was defined as increase in serum creatinine by ≥1 mg/dL or reduction from baseline ClCR of ≥20% or need for renal replacement therapy (RRT)."|Up to Day 35 (up to 14 days after completing study treatment)|All participants in Groups 1 and 2 who received ≥1 dose of study drug are included. Per protocol, Group 3 was not included in the nephrotoxicity analysis.|||Percentage of Participants||95% Confidence Interval|Number
2576383|NCT02452047|Primary|Percentage of Participants With ≥1 Events of Clinical Interest (ECI)|The percentage of participants in Groups 1, 2, and 3 having ECIs within 2 categories was determined. Category 1 ECIs included post-baseline laboratory values of an elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value that is ≥3x upper limit of normal (ULN) and an elevated total bilirubin value that is ≥2x ULN and (at the same time) an alkaline phosphatase value that is ≤2x ULN. Category 2 ECIs included a confirmed elevated AST or ALT value that is ≥5x ULN. Statistical analysis included only Groups 1 and 2 as indicated by the protocol.|Up to Day 35 (up to 14 days after completing study treatment)|All participants in Groups 1, 2, and 3 who received ≥1 dose of study drug are included.|||Percentage of Participants|||Number
2576402|NCT02451943|Secondary|PK: Volume of Distribution at Steady State (Vss) of Olaratumab: Mean Parameter Estimate|The PK parameter estimates from the current analysis are listed together with the population PK model estimates. The Vss is the sum of central volume of distribution (V1) + peripheral volume of distribution (V2).|Cycle 1- 9: Day 1 and 8; Predose, 5 Minutes Post dose and then every other cycle and follow-up (30 Days)|All randomized participants who had received at least one dose of study drug and had evaluable PK data.|||Liter (L)||95% Confidence Interval|Mean
2576384|NCT02452047|Primary|Analysis of Specific AEs With an Incidence of ≥4 Participants in a Treatment Group|The percentage of participants experiencing AEs that occurred in ≥4 participants within either Group 1 or Group 2 was assessed. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Statistical analysis included only Groups 1 and 2 as indicated by the protocol; Group 3 had <4 participants and therefore no data are presented.|Up to Day 35 (up to 14 days after completing study treatment)|All participants in Groups 1 and 2 who received ≥1 dose of study drug are included. Group 3 data is not shown for this measure because there are only 3 participants.|||Percentage of Participants|||Number
2576385|NCT02452047|Primary|Percentage of Participants Discontinuing From Study Therapy Due to ≥1 Drug-Related AEs|The percentage of participants in Groups 1, 2, and 3 discontinuing from study drug due to ≥1 drug-related AEs during the treatment period was determined. A drug-related AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, and considered by the investigator to be related to the study intervention. Statistical analysis included only Groups 1 and 2 as indicated by the protocol.|Up to Day 21|All participants in Groups 1, 2, and 3 who received ≥1 dose of study drug are included.|||Percentage of Participants|||Number
2576386|NCT02452047|Primary|Percentage of Participants Discontinuing From Study Therapy Due to ≥1 AEs|The percentage of participants in Group 1, 2, and 3 discontinuing from study drug due to ≥1 AEs during the treatment period was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Statistical analysis included only Groups 1 and 2 as indicated by the protocol.|Up to Day 21|All participants in Groups 1, 2, and 3 who received ≥1 dose of study drug are included.|||Percentage of Participants|||Number
2576387|NCT02452047|Primary|Percentage of Participants With ≥1 Drug-Related SAEs|The percentage of participants in Groups 1, 2, and 3 experiencing ≥1 drug-related SAEs during treatment and 14-day follow-up was determined. A drug-related SAE is any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant injury/incapacity; is a congenital anomaly/birth defect; or is an other important medical event, that is considered by the investigator to be related to the study intervention. Statistical analysis included only Groups 1 and 2 as indicated by the protocol.|Up to Day 35 (up to 14 days after completing study treatment)|All participants in Groups 1, 2, and 3 who received ≥1 dose of study drug are included.|||Percentage of Participants|||Number
2576388|NCT02452047|Primary|Percentage of Participants With ≥1 Drug-Related AEs|The percentage of participants in Groups 1, 2, and 3 experiencing ≥1 drug-related AEs during treatment and 14-day follow-up was determined. A drug-related AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, and considered by the investigator to be related to the study intervention. Statistical analysis included only Groups 1 and 2 as indicated by the protocol.|Up to Day 35 (up to 14 days after completing study treatment)|All participants in Groups 1, 2, and 3 who received ≥1 dose of study drug are included.|||Percentage of Participants|||Number
2576389|NCT02452047|Primary|Percentage of Participants With ≥1 Serious Adverse Events (SAEs)|The percentage of participants in Groups 1, 2, and 3 experiencing ≥1 SAEs during treatment and 14-day follow-up was determined. An SAE is any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant injury/incapacity; is a congenital anomaly/birth defect; or is an other important medical event. Statistical analysis included only Groups 1 and 2 as indicated by the protocol.|Up to Day 35 (up to 14 days after completing study treatment)|All participants in Groups 1, 2, and 3 who received ≥1 dose of study drug are included.|||Percentage of Participants|||Number
2576390|NCT02452047|Primary|Percentage of Participants With ≥1 Adverse Events (AEs)|The percentage of participants in Groups 1, 2, and 3 experiencing ≥1 AEs during treatment and 14-day follow-up was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Statistical analysis included only Groups 1 and 2 as indicated by the protocol.|Up to Day 35 (up to 14 days after completing study treatment)|All participants in Groups 1, 2, and 3 who received ≥1 dose of study drug are included.|||Percentage of Participants|||Number
2576391|NCT02452047|Primary|Percentage of Participants With Favorable Overall Response (FOR)|The percentage of participants with FOR was determined for Groups 1 and 2. FOR was determined based on clinically relevant outcomes for the primary site of infection as follows: HABP/VABP: survival through Day 28; cIAI: favorable clinical response (all pretherapy symptoms of index infection resolved with no evidence of resurgence, no additional antibiotic therapy required, and no unplanned surgical or percutaneous drainage procedures) at Day 28; cUTI: favorable composite clinical response (all pretherapy symptoms of index infection resolved with no evidence of resurgence, no additional antibiotic therapy required) and microbiological response (urine culture shows sustained eradication of the baseline uropathogen [e.g., ≥10^5 CFU/mL at study entry is reduced to <10^4 CFU/mL]) at Early Follow-up (EFU).|Up to Day 30 (up to 9 days after completing study treatment)|Participants in Groups 1 and 2 who received ≥1 dose of each trial drug within a given IV treatment regimen, and who had a baseline bacterial pathogen that met inclusion criteria, are included. As per protocol, efficacy data from open-label Group 3 was considered exploratory and not included in the comparative analysis.|||Percentage of Participants||95% Confidence Interval|Number
2576392|NCT02452034|Secondary|Number of Participants Who Discontinued Treatment of Study Drug Due to an Adverse Event (AE)|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to 28 days|All participants who received at least one dose of study drug. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.|||Participants|||Count of Participants
2576393|NCT02452034|Secondary|Number of Participants With an Adverse Event (AE)|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|14 days after end of treatment (Up to 42 days)|All participants who received at least one dose of study drug. Data were analysed as pre-specified in the study protocol, based on age group and dosage, and did not distinguish oral from IV formulation.|||Participants|||Count of Participants
2576394|NCT02452034|Primary|Apparent Total Body Clearance (CL/F) for POS Administered by PFS|Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma CL/F of posaconazole administered by PFS. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for participants that received PFS treatment.|Any day from Day 7 to Day 10 of therapy (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion|All treated participants who received at least 7 days of POS PFS therapy, completed the full POS PK sampling while on POS PFS, and met pre-specified acceptability criteria.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2576395|NCT02452034|Primary|Total Body Clearance (CL) for POS Administered by IV|Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma CL of posaconazole administered by IV. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for participants that received IV treatment.|Any day from Day 7 to Day 10 of therapy (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion|All treated participants who received at least 7 days of POS IV solution therapy, completed the full POS PK sampling while on POS IV solution, and met pre-specified acceptability criteria.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2576396|NCT02452034|Primary|Time of Maximum Plasma Concentration (Tmax) for POS|Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma Tmax of posaconazole. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation.|Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion|All treated participants who received at least 7 days of POS dosing (IV and PFS), completed the full POS PK sampling, and met pre-specifiied acceptability criteria.|||Hours||Full Range|Median
2576397|NCT02452034|Primary|Average Steady-state Plasma Concentration (Cavg) for POS|Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma Cavg of posaconazole. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation.|Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion|All treated participants who received at least 7 days of POS dosing (IV and PFS), completed the full POS PK sampling, and met pre-specifiied acceptability criteria.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2576398|NCT02452034|Primary|Minimum Plasma Concentration (Cmin) for POS|Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma Cmin of posaconazole. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation.|Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion|All treated participants who received at least 7 days of POS dosing (IV and PFS), completed the full POS PK sampling, and met pre-specifiied acceptability criteria.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2576399|NCT02452034|Primary|Maximum Plasma Concentration (Cmax) for POS|Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma Cmax of posaconazole. A non-compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation.|Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion|All treated participants who received at least 7 days of POS dosing (IV and PFS), completed the full POS PK sampling, and met pre-specifiied acceptability criteria.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2576400|NCT02452034|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to 24 Hours Post-dose for POS|Blood was collected from pre-dose up to 24 hours post-dose in order to determine the plasma AUC from time 0-24 hours post-dose (AUC0-24hr) of posaconazole. A non compartmental analysis of posaconazole plasma concentrations was performed. Results are reported for each treatment arm according to the formulation that participants received (IV or PFS). Participants receiving both formulations were counted once for each formulation.|Any day from Day 7 to Day 10 of therapy for each formulation (up to 28 days) at pre-dose, within 15 minutes after end of infusion (up to 2 hours), and 4, 6, 8, 12, 24 hours post-infusion|All treated participants who received at least 7 days of POS dosing (IV and PFS), completed the full POS PK sampling, and met pre-specifiied acceptability criteria.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2576401|NCT02451995|Primary|A Composite of the Total Number of Participants With Either Tachycardia Change or Tachycardia Termination With First Ablation Set.|The total number of participants in each arm with either a change of termination of their atrial tachycardia following delivery of the first ablation set post map categorisation.|Participants will be followed for the duration of hospital stay (typically an overnight stay, hence 24hrs.||||Participants|||Count of Participants
2576405|NCT02451943|Secondary|Duration of Overall Response (DoR)|The duration of overall response was defined for each participant with a best response of CR or PR and measured from the time measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that disease is recurrent or objective disease progression or death due to any cause is observed (taking as reference for PD the smallest measurements recorded on study).|Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 33.4 Months)|All randomized participants who have evaluable DoR data.|||Months||95% Confidence Interval|Median
2576406|NCT02451943|Secondary|"Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) Worst Pain Score"|"Time to first worsening of the brief pain inventory short form modified (mBPI-sf) worst pain score was defined as the time from the date of the first study drug dose (baseline date) to the first date of a worst pain score increase of greater than or equal to (≥) 2 points from baseline. The mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes)."|Randomization through Follow-up (Up to 34.5 Months)|All randomized participants who completed at least 1 baseline assessment and at least 1 subsequent assessment during the study period.|||Months||95% Confidence Interval|Median
2576407|NCT02451943|Secondary|Change From Baseline to Maximum Improvement in Health Status Index Score on the EuroQol 5-Dimension 5-Level (EQ-5D-5L)|The EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of a descriptive system of the respondent's health which comprises the following 5 dimensions: (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Health status was calculated from a set of item weights to derive a score of 0 to 1, with 1 representing the best health status. United Kingdom (UK) weights were applied. The analysis includes all cycles for which at least 25% of participants in each arm have an assessment. For each participant a change from baseline was calculated for every post-baseline assessment by subtracting the baseline assessment result from the current assessment result. Maximum improvement (over baseline) was determined from the set of all post-baseline change scores.|Randomization through Follow-up (Up to 35.8 Months)|All randomized participants who had a baseline and a post-baseline measurement.|||change in score on a scale from baseline||Standard Deviation|Mean
2576408|NCT02451943|Secondary|Time to First Worsening on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores|"Time to first worsening was calculated as the time from the first study drug dose to the first observation of worsening according to the EORTC QLQ-C30 Scoring Manual (Fayers et al. 2001). The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 total items covered by 1 of 3 dimensions (1 global health status/QoL total score, 5 functional subscales [physical, role, cognitive, emotional, and social]), and 9 symptom subscales [fatigue/nausea/vomiting/pain/dyspnea/insomnia/appetite loss/constipation/diarrhea]). There are 28 questions answered on a 4-point scale where 1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best). A linear transformation was used to obtain total score ranging from 0 to 100 where worsening was defined as an increase of at least 10 points for the symptom scales or a decrease of at least 10 points for the functional scales and the global health status/QoL scale."|Randomization (Cycle 1) through Follow-up (Up to 35.8 Months)|All randomized participants who completed at least 1 baseline assessment and at least 1 subsequent assessment during the study period.|||Months||95% Confidence Interval|Median
2576409|NCT02451943|Secondary|Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)|DCR was defined as the percentage of randomized participants achieving a best overall response of CR, PR, or SD per RECIST v.1.1. CR is the disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PD is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Randomization to Objective Disease Progression or Death Due to Any Cause (Up to 45 Months)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2576410|NCT02451943|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)|ORR was defined as the percentage of participants achieving a best overall response of complete response (CR) + partial response (PR). CR is the disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. Best overall response is classified based on the overall responses assessed by study investigators according to RECIST v1.1.|Randomization to Objective Disease Progression or Death Due to Any Cause (Up to 35.8 Months)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2576411|NCT02451943|Secondary|Progression Free Survival (PFS)|PFS was defined by (Response Evaluation Criteria In Solid Tumors RECIST v.1.1) as the time from the date of randomization to the first date of radiologic disease progression or death due to any cause. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 millimeter (mm), or unequivocal progression of non-target lesions, or 1 or more new lesions. Censoring for death or PD due to increase sum of target lesions is defined for each participant as the time from the date of randomization to the first date of radiographic documentation of 1 or more lesions. Censoring for death without progression is defined as the date of death if there is no prior or concurrent radiologic disease progression.|Randomization to Objective Progression or Death Due to Any Cause (Up to 35.8 Months)|All randomized participants. Censored participants in the Doxorubicin + Olaratumab arm = 39 and the Doxorubicin + Placebo arm =34.|||Months||95% Confidence Interval|Median
2576412|NCT02451943|Primary|Overall Survival (OS) Leiomyosarcoma (LMS)|Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters.|Randomization to Date of Death Due to Any Cause (Up to 35.8 Months)|All randomized participants with LMS. Censored participants in Doxorubicin + Olaratumab arm = 42 and Doxorubicin + Placebo arm = 40.|||Months||95% Confidence Interval|Median
2576413|NCT02451943|Primary|Overall Survival (OS)|Overall survival was defined as the time from the date of randomization to the date of death due to any cause. For each participant, prior to data analysis, a reasonable effort was made to obtain the most up-to-date status (date of death or last date known to be alive). For any participant not known to have died as of the data cutoff date, OS was censored at the date the participant was last known to be alive. For any participant who withdrew consent for survival follow-up, OS was censored at the last date for which the participant provided consent for follow-up contact. The Kaplan-Meier method was used to estimate median parameters.|Randomization to Date of Death Due to Any Cause (Up to 35.8 Months)|All randomized participants. Censored participants in Doxorubicin + Olaratumab arm = 87 and Doxorubicin + Placebo arm = 91|||Months||95% Confidence Interval|Median
2576414|NCT02451917|Other Pre-specified|Estimated Glomerular Filtration Rate (eGFR) Calculated by CKD-EPI|"Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation is one of the most widely used IDMS traceable equations for estimating GFR in patients age 18 and over. CKD-EPI equation includes variables for age, gender, and race, which may allow providers to observe that CKD is present despite a serum creatinine concentration that appears to fall within or just above the normal reference interval.~CKD-EPI equation expressed as a single equation: GFR = 141 × min (Scr /κ, 1)α × max(Scr /κ, 1)-1.209 × 0.993Age × 1.018 [if female] × 1.159 [if black] where: Scr is serum creatinine in mg/dL, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males,min indicates the minimum of Scr /κ or 1, and max indicates the maximum of Scr /κ or 1."|baseline and 24 weeks||||ml/min/1.7m²||Standard Deviation|Mean
2576415|NCT02451917|Other Pre-specified|Serum Creatinine|Creatinine is measured in milligrams per deciliter of blood (mg/dL|baseline and 24 weeks|Creatinine endpoint was assessed using an analysis of covariance (ANOVA) model.|||mg/dL||Standard Deviation|Mean
2576416|NCT02451917|Other Pre-specified|Body Mass Index (BMI)|The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.|baseline and 24 weeks|BMI endpoint was assessed using an analysis of covariance (ANOVA) model.|||Kg/m²||Standard Deviation|Mean
2576417|NCT02451917|Other Pre-specified|Total Daily Insulin Dose|Daily total insulin dose at baseline compared to dose at week 24.|baseline and 24 weeks|Randomization was stratified by the A1c value at baseline: <9.0% or ≥9.0%, in a 1:1 ratio, and the individuals who met all inclusion-criteria were allocated alternately to either an IGlar/INPH or an INPH/IGlar treatment sequence.|||units/Kg/day||Standard Deviation|Mean
2576418|NCT02451917|Other Pre-specified|Glycemic Variability|In order to observe variability in interstitial glucose levels related to the therapy in use, participants wore a blinded CGM for 3 days. Changes in glycemic patterns were expressed by the average daily time spent in hypoglycemia (≤70 mg/dL or <3.9 mmol/L), hyperglycemia (>180 mg/dL or >10 mmol/L) and euglycemia (70-180 mg/dL or 3.9-10 mmol/L).|24 week|Patients were excluded from the analysis because of unfamiliarity with mechanical procedures related to the CGM use, visual impairment or technical problems with the sensor measurement.|||percentage of time||Standard Deviation|Mean
2576419|NCT02451917|Primary|Number of Hypoglycemic Events|"Hypoglycemia was defined by capillary glycemia< 70 mg/dL (3.9 mmol/L), even if it was not accompanied by typical symptoms. Otherwise, hypoglycemia was classified as severe with SMBG below 50 mg/dL (2.8 mmol/L) or when it resulted in stupor, seizure, or unconsciousness that precluded self-treatment, thus requiring the assistance of another individual. Nocturnal events were defined as SMBG < 70mg/dL occurring after midnight and before wake-up in the morning (before 7:00am)12."|between 1rst and 24 weeks of each treatment arm|Endpoint hypoglycemia was assessed using an analysis of covariance (ANOVA) model|||events per patients during 24 weeks||Standard Deviation|Mean
2576420|NCT02451917|Primary|Difference in A1c Levels|A1c using high performance liquid chromatography measured in percentage|baseline and 24 weeks|Primary endpoint A1c was assessed using an analysis of covariance (ANOVA) model.|||percentage||Standard Deviation|Mean
2576421|NCT02451839|Secondary|Number of Participants Remaining on Treatment at Month 6|The number of participants at 6 months who remained on adalimumab, having satisfied the requirements for application for renewal of subsidy by special authority.|Month 6|Participants completing the study at 6 months. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.|||Participants|||Count of Participants
2576422|NCT02451839|Secondary|Change From Baseline in DLQI Score at Month 6 in Participants With Psoriasis|The DLQI measures 10 items covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment, to determine how much the patients skin problem affected their life in the past week. Participants respond to the questions with 'very much,' 'a lot,' 'a little,' or 'not at all.' The scores are added together, and the impact on QoL is banded as follows: 0-1=no effect on participant's life; 2-5=small effect; 6-10=moderate effect; 11-20=very large effect; 21-30=extremely large effect.|Baseline, Month 6|Participants with psoriasis and baseline and Month 6 assessments.|||score on a scale||Standard Deviation|Mean
2576423|NCT02451839|Secondary|Change From Baseline in SIBDQ Score at Month 6 in Participants With Crohn's Disease|The SIBDQ is a simple validated, 10-item questionnaire designed to find out how the patient has been feeling in the previous 2 weeks. QoL is measured in 4 domains: bowel symptoms, emotional health, systemic systems and social function. Participants respond to questions ranging from 1=all of the time to 7=none of the time. Scores are added together, with higher scores indicating a better health-related QoL. Total scores range from 10 (poor QoL) to 70 (good QoL).|Baseline, Month 6|Participants with Crohn's disease and baseline and Month 6 assessments.|||score on a scale||Standard Deviation|Mean
2576424|NCT02451839|Secondary|Change From Baseline in HAQ-DI Score at Month 6 in Participants With Rheumatoid Arthritis|HAQ-DI measures functional status in rheumatic diseases. It has 20 items, and asks patients to report the degree of difficulty faced in several areas of their life including: dressing and grooming, arising, eating, walking, hygiene, reach, grip, activities based on the previous week on a scale from 0 (without any difficulty) to 3 (cannot be done at all). It also asks the participant to rate their pain and health in the previous week. Scores on each task are summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high-dependency disability).|Baseline, Month 6|Participants with rheumatoid arthritis baseline and Month 6 assessments.|||score on a scale||Standard Deviation|Mean
2576425|NCT02451839|Secondary|Change From Baseline in Subjective Vitality Scale at Month 6 Across All Indications|The Subjective Vitality Scale assesses the state of feeling alive and alert to having energy available to the self. Patients respond to eight prompts, with a response ranging from 1=strongly disagree to 7=strongly agree. The sum of the scores is calculated with a higher score indicating a better condition. The total score ranges from 8 to 56 with a higher score indicating a better condition.|Baseline, Month 6|Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.|||units on a scale||Standard Deviation|Mean
2576426|NCT02451839|Secondary|Change From Baseline in Flourishing Scale at Month 6 Across All Indications|The Flourishing Scale is a brief 8-item summary measure of the respondent's self-perceived success in important areas such as relationships, self-esteem, purpose, and optimism. The scale provides a single psychological well-being score. Participants are asked to respond to 8 statements using a scale of 1 (strongly disagree) and 7 (strongly agree) for each item. The possible range of scores is from 8 (lowest possible) to 56 (highest possible), with higher scores representing more psychological resources and strengths.|Baseline, Month 6|Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.|||units on a scale||Standard Deviation|Mean
2576427|NCT02451839|Secondary|Change From Baseline in K10 at Month 6 Across All Indications|The K10 is intended to yield a global measure of distress based on a questionnaire about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. The K10 scale involves 10 questions about emotional states each with a 5-level response scale. Each item is scored from 1=none of the time to 5=all of the time. Scores of the 10 items are then summed, yielding a minimum score of 10 and a maximum score of 50. Low scores indicate low levels of psychological distress and high scores indicate high levels of psychological distress.|Baseline, Month 6|Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.|||units on a scale||Standard Deviation|Mean
2576428|NCT02451839|Secondary|Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Activity Impairment|WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.|Baseline, Month 6|Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.|||percentage of activity impariment||Standard Deviation|Mean
2576429|NCT02451839|Secondary|Change From Baseline in WPAI:GH 2.0 Score at Month 6 Across All Indications: Work Productivity Loss|WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.|Baseline, Month 6|Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.|||percentage overall work impairment||Standard Deviation|Mean
2576430|NCT02451839|Secondary|Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Presenteeism|WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.|Baseline, Month 6|Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.|||percentage impairment time||Standard Deviation|Mean
2576463|NCT02451150|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan) Metabolite M-I|AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
2576813|NCT02447029|Secondary|Overall Complication Rate as Measured by a Count of Participants in Each Group||Rate of complications at the end of the study|All treated patients were analyzed|||Participants|||Count of Participants
2576431|NCT02451839|Secondary|Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Absenteeism|WPAI:GH is a 6-item questionnaire looks at the effect of health problems on ability to work and perform regular activities. The WPAI yields 4 types of scores: absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. The questionnaire specifies responses for the previous 7 days.|Baseline, Month 6|Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.|||percentage of work time missed||Standard Deviation|Mean
2576432|NCT02451839|Secondary|Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Rheumatoid Arthritis|WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.|Baseline, Month 6|Participants with rheumatoid arthritis and baseline and Month 6 assessments.|||units on a scale||Standard Deviation|Mean
2576433|NCT02451839|Secondary|Change From Baseline in WHODAS 2.0 Response Score at Month 6 In Participants With Psoriasis|WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.|Baseline, Month 6|Participants with psoriasis and baseline and Month 6 assessments.|||units on a scale||Standard Deviation|Mean
2576434|NCT02451839|Secondary|Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Crohn's Disease|WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.|Baseline, Month 6|Participants with Crohn's disease and baseline and Month 6 assessments.|||units on a scale||Standard Deviation|Mean
2576435|NCT02451839|Secondary|Change From Baseline in WHODAS 2.0 Response Score at Month 4 Across All Indications|WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.|Baseline, Month 4|Participants with baseline and Month 4 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.|||units on a scale||Standard Deviation|Mean
2576436|NCT02451839|Secondary|Change From Baseline in WHODAS 2.0 Response Score at Month 2 Across All Indications|WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.|Baseline, Month 2|Participants with baseline and Month 2 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.|||units on a scale||Standard Deviation|Mean
2576437|NCT02451839|Primary|Change From Baseline in WHODAS 2.0 Response Score at Month 6 Across All Indications|WHODAS 2.0 is a measures health and disability across cultures in all adult populations by assessing the same individual before and after the intervention across 12 items, covering the following 6 domains: cognition, mobility, self-care, getting along, life activities and participation. Scores assigned to each of the items (none=0, mild=1, moderate=2, severe=3, and extreme=4) are summed. Scores can range from 0 to 48. Persons scoring 10 to 48 are likely to have clinically significant disability.|Baseline, Month 6|Participants with baseline and Month 6 assessments. Per protocol, primary and secondary endpoint data [other than the endpoints presented in Outcome Measures 4-6 and 14-16] were intended to be analyzed across all indications; therefore, data are presented for all participants as a single group.|||units on a scale||Standard Deviation|Mean
2576438|NCT02451670|Primary|Predicted Annual Rate of Change in 10 Year Risk of Fatal or Nonfatal Heart Attack or Stroke|A modifiable risk component for each cardiovascular risk factor not at optimal goal at the time of each encounter was calculated as the difference between total 10-year atherosclerotic cardiovascular disease risk with the patient's actual values and the goal value. Total modifiable cardiovascular risk was calculated by summing the modifiable cardiovascula risk components across cardiovascular risk factors not at optimal goal at the time of the encounter, and was calculated for each enrolled patient at the index visit and each subsequent encounter during the intervention period. Annual rate of change in modifiable cardiovascular risk was estimated from all patient encounters. A comparison of the difference in model-estimated rate of change in modifiable cardiovascular risk at 12 months post-index tested the primary efficacy hypothesis.|Index to 12 months post index visit|The patients whose data were included in the primary outcome analysis met eligibility criteria, had an index visit at a randomized clinic at which they were eligible for the Cardiovascular Wizard intervention, and had at least one follow-up visit in a randomized primary care clinic.|||percentage of annual rate of change|||Number
2579902|NCT02412501|Secondary|Number of Participants With Target Lesion Failure (TLF) at 24 Months Post Procedure||24 Months||||Participants|||Count of Participants
2576439|NCT02451488|Primary|Th1/Th2 Normalized Gene Expression|The Th1/Th2/Th3 Reverse transcription polymerase chain reaction (RT-qPCR) arrays will be used to quantify RNA expression of Th1 and Th2 messenger ribonucleic acids (mRNAs). Normalized gene expression was calculated from qRT-PCR results comparing GM-CSF and control subjects for both Th1-associated gene T-bet and Th2-associated gene GATA3 respectively. Fold change values are calculated by taking the normalized gene expression in GM-CSF treated group samples divided by the normalized gene expression in the control group samples.|14 days post treatment|Three subjects were in in the GM-CSF group and three subjects were in the Standard of Care group. One subject in the GM-CSF group received GM-CSF but did not have tissue sample collected for research analysis. One subject in the Standard of Care group did not have a large enough tissue sample collected to be analyzed.|||fold change||95% Confidence Interval|Mean
2576440|NCT02451358|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccination With Influenza Vaccine|"Solicited injection site reactions:~Age 6-23 months: Tenderness, Erythema and Swelling(Grade 3: Tenderness: cries when injected limb is moved; Erythema and Swelling:>=50 mm)~Age >=2 years: Pain, Erythema and Swelling (Grade 3: Pain:unable to perform usual activities [age 2-11 years], significant interference with daily activities [age >=12 years]; Erythema and Swelling >=50 mm [age 2-11 years], >100 mm [age >=12 years])~Solicited systemic reactions:~Age 6-23 months: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite loss, Irritability (Grade 3: Fever:>39.5 degree Celsius; Vomiting:>=6 episodes/24 hours; Crying abnormal:>3 hours; Drowsiness:sleeping most of the time or difficult to wake up; Appetite loss: refuses >=3 feeds/meals or most feeds/meals; Irritability: inconsolable)~Age >=2 years:Fever, Headache, Malaise, Myalgia and Shivering (Grade 3:Fever>=39.0 degree Celsius; Headache, Malaise, Myalgia and Shivering:significant interference in daily activities)"|Within 7 days after any vaccination|Analysis was performed using Safety Analysis Set which included all participants who received at least 1 dose of study vaccine. Here, ‘Number Analyzed’ = those participants with available data for specified categories. 'Number analyzed' = 0 signifies that reported reaction was not analyzed in the specified age group.|||Participants|||Count of Participants
2576441|NCT02451358|Primary|Number of Participants With Seroconversion or Significant Increase to Influenza Vaccine Antigens|Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroconversion was defined as pre-vaccination titer <10 (1/dil) and post-vaccination titer >=40 (1/dil), and Significant increase was defined as pre-vaccination titer >=10 (1/dil) and >= 4-fold increase of post-vaccination titer.|28 days post-final vaccination (post-vaccination)|Analysis was performed using FAS which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.|||Participants|||Count of Participants
2576442|NCT02451358|Primary|Number of Participants With Seroprotection to Influenza Vaccine Antigens|Anti-influenza antibodies were measured using HAI assay for 4 strains: H1N1, H3N2, B Victoria and B Yamagata. Seroprotection was defined as an antibody titer >=40 (1/dilution[dil]) at pre-vaccination and at post-final vaccination.|Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)|Analysis was performed using FAS which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.|||Participants|||Count of Participants
2576443|NCT02451358|Primary|Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies|Anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 strains: H1N1, H3N2, B Victoria, B Yamagata.|Day 0 (pre-vaccination) and 28 days post-final vaccination (post-vaccination)|Analysis was performed using Full Analysis Set (FAS) which included all participants who received at least 1 dose of vaccine and had at least 1 valid post-vaccination serology result. Here, 'Number Analyzed' = those participants with available data for specified categories.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
2576444|NCT02451202|Secondary|Time to Modified Aldrete's Score ≥ 9|Time from Post Anesthesia Care Unit (PACU) arrival to patients were considered fit for discharge from the PACU by Modified Aldrete's score assessment which scale range is from 0-10. Higher value represents a better outcome.|Minutes from Post Anesthesia Care Unit (PACU) arrival to patients were considered fit for discharge from the PACU.||||Minutes||Inter-Quartile Range|Median
2576445|NCT02451202|Primary|Proportion of Patients Who Have a Clinically Acceptable Surgical Conditions|Proportion of patients who have a excellent and good surgical condition score|intraoperative||||Proportion of patients|||Number
2576446|NCT02451150|Primary|Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Laboratory Test Results|Laboratory test results are defined as serum chemistry, hematology and urinalysis.|Baseline and Day 2|Safety population includes all participants who received at least one dose of study drug.|||percentage of participants|||Number
2576447|NCT02451150|Primary|Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Resting 12-Lead Electrocardiogram (ECG)|A resting 12-lead ECG was recorded. The investigator or subinvestigator (or a qualified physician at the study site) interpreted the ECG results.|Baseline and Day 2|Safety population includes all participants who received at least one dose of study drug.|||percentage of participants|||Number
2576448|NCT02451150|Primary|Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Body Weight||Baseline and Day 2|Safety population includes all participants who received at least one dose of study drug.|||percentage of participants|||Number
2576449|NCT02451150|Primary|Percentage of Participants With Remarkable Findings of Clinical Concern From Baseline in Vital Signs|Vital signs are defined as sitting blood pressure, sitting pulse rate and temperature.|Baseline and Day 2|Safety population includes all participants who received at least one dose of study drug.|||percentage of participants|||Number
2576464|NCT02451150|Primary|T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan)|T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||hours||Standard Deviation|Mean
2576759|NCT02447887|Primary|Grade 4 Neutropenia Per CTCAE v4; Associated With Fever or Hospitalization for Infection||Up to week 8|Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.||||||
2576450|NCT02451150|Primary|Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Treatment emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Up to 15 Days|Safety population includes all participants who received at least one dose of study drug.|||participants|||Number
2576451|NCT02451150|Primary|Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan) Metabolite M-II|The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 metabolite M-II will be calculated from the urinary concentration and volume of each participant.|Day 1 from 0 to 24 hours post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||percent of dose||Standard Deviation|Mean
2576452|NCT02451150|Primary|Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan) Metabolite M-I|The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 metabolite M-I will be calculated from the urinary concentration and volume of each participant.|Day 1 from 0 to 24 hours post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||percent of dose||Standard Deviation|Mean
2576453|NCT02451150|Primary|Cumulative Urinary Excretion Ratio of TAK-536 (Azilsartan)|The cumulative urinary excretion ratio (% of dose [TAK-536-equivalent]) of TAK-536 will be calculated from the urinary concentration and volume of each participant.|Day 1 from 0 to 24 hours post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||percent of dose||Standard Deviation|Mean
2576454|NCT02451150|Primary|T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan) Metabolite M-II|T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||hours||Standard Deviation|Mean
2576455|NCT02451150|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan) Metabolite M-II|Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||hours||Full Range|Median
2576456|NCT02451150|Primary|AUC(0-inf) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan) Metabolite M-II|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
2576457|NCT02451150|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan) Metabolite M-II|Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||ng/mL||Standard Deviation|Mean
2576458|NCT02451150|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan) Metabolite M-II|AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
2576459|NCT02451150|Primary|T1/2: Terminal Elimination Half-Life of TAK-536 (Azilsartan) Metabolite M-I|T1/2 is the terminal elimination half-life (time required for half of the drug to be eliminated from the plasma), calculated as T1/2=ln(2)/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||hours||Standard Deviation|Mean
2576460|NCT02451150|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan) Metabolite M-I|Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||hours||Full Range|Median
2576461|NCT02451150|Primary|AUC(0-inf) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan) Metabolite M-I|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
2576462|NCT02451150|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan) Metabolite M-I|Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||ng/mL||Standard Deviation|Mean
2576760|NCT02447887|Primary|Thrombocytopenia ≥ Grade 3 Per CTCAE v4||Up to week 8|Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.||||||
2576465|NCT02451150|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of TAK-536 (Azilsartan)|Tmax is the time to reach Cmax (actual measurement value), equal to time (hours) to Cmax.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||hours||Full Range|Median
2576466|NCT02451150|Primary|AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-536 (Azilsartan)|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity, calculated as AUC(0-inf)=AUC(0-tlqc)+lqc/λz|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
2576467|NCT02451150|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-536 (Azilsartan)|Cmax is the maximum observed plasma concentration (actual measurement value) of a drug after administration, obtained directly from the plasma concentration-time curve.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||ng/mL||Standard Deviation|Mean
2576468|NCT02451150|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to Time 24 Hours of TAK-536 (Azilsartan)|AUC(0-24) is a measure of total plasma exposure to the drug from time 0 to 24 hours post-dose, calculated using the linear trapezoidal rule.|Pre-dose and at multiple time points (up to 24 hours) post-dose|PK population includes all participants who received the study drug without any major protocol deviation, and were evaluable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
2576469|NCT02451137|Secondary|Percentage of Participants With at Least One Treatment-Emergent Hypoglycemia Event (Any Time of the Day, Nocturnal) Per Type of Hypoglycaemia During the Month 6 and Month 12 on Treatment Period|Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (<=3.9 mmol/L) or <54 mg/dL (3.0 mmol/L).|Up to Month 6 and Month 12|Analysis was performed on safety population.|||percentage of participants|||Number
2576470|NCT02451137|Secondary|Percentage of Participants With Hospitalizations, Emergency Rooms and Specialty Visits From Baseline to Month 6 and Month 12|Percentage of participants with hospitalizations, emergency room visits, and specialty visits during the 6-month and 12-month randomized period were reported. The 12-month randomized period was defined as the time from randomization up to Day 365 or discontinuation date, whichever comes earlier.|From Baseline to Month 6 and Month 12|Analysis was performed on ITT population.|||percentage of participants|||Number
2576471|NCT02451137|Secondary|Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Change Version (DTSQc) at Month 12|DTSQc version evaluates the change in treatment satisfaction at Month 12 as compared to the start of the study . It consists of 8 items, each answered on a Likert scale from -3 to +3. The sum of treatment satisfaction scores (items 1, 4, 5, 6, 7,and 8) ranged from score -18 (deterioration in treatment satisfaction) to +18 (improvement in treatment satisfaction). Perceived frequency of hypoglycemia and perceived frequency of hyperglycemia score ranges from score -3 (fewer problems) to +3 (more problems).|At Month 12|"Analysis was performed on ITT population. Here, number analyzed = participants with available data for assessment during the 12 month randomized period."|||score on a scale||Standard Error|Least Squares Mean
2576472|NCT02451137|Secondary|Scores of Total Treatment Satisfaction, Hyperglycemia Perception, and Hypoglycemia Perception From Diabetes Treatment Satisfaction Questionnaire Status Version (DTSQs) at Baseline, Month 6, Month 12|DTSQs is a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consists of 8 items, each answered on a Likert scale of 0 to 6. Responses of 6 questions (Items 1, 4, 5, 6, 7 and 8) were summarized to derive total treatment satisfaction score, such that a higher score was indicative of better satisfaction. Total treatment satisfaction score is the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (improvement in treatment satisfaction). Item 2 and Item 3 scores were used for hyperglycemia perception and hypoglycemia perception respectively, where lower scores indicated better health outcome. Perceived frequency of hyperglycemia score (Item 2) and perceived frequency of hypoglycemia score (Item 3) range from 0 (none of the time) to 6 (most of time), where lower scores indicated more satisfaction/better health outcome.|At Baseline, Month 6, Month 12|"Analysis was performed on ITT population. Here, number analyzed = participants with available data for each specified category."|||score on a scale||Standard Deviation|Mean
2576473|NCT02451137|Secondary|"Percentage of Responders (Participants and Provider) Who Reported Excellent or Good Responses to Global Effectiveness Scale (GES) Question at Month 6, and Month 12"|"Participant and Physician (Provider) reported GES for this diabetes study. The GES assessed impact of treatment on scale ranges as: excellent (complete control of diabetes), good (marked improvement of diabetes), moderate (discernible, but limited improvement in diabetes), poor (no appreciable change in diabetes), or worsening of condition (worsening of diabetes). There was no score expressed by numbers and no change measured over the time of the study. Percentage of participants and providers who reported excellent or good on the GES at Month 6 and Month 12 are reported here."|At Month 6, Month 12|Analysis was performed on ITT population.|||percentage of responders|||Number
2576474|NCT02451137|Secondary|Change From Baseline in Basal Insulin Dose at Month 6 and Month 12|Change in basal insulin dose was calculated by subtracting baseline value from Month 6 and Month 12 values.|Baseline, Month 6, Month 12|Analysis was performed on safety population. Here, ‘Number analyzed’ = participants with available data for each specified category.|||Unit/kg (U/kg)||Standard Deviation|Mean
2576475|NCT02451137|Secondary|Change From Baseline in Body Weight at Month 6 and Month 12|Adjusted LS means and SE were obtained using MMRM model with fixed categorical effects of treatment arm, visit, treatment arm-by-visit interaction, randomization strata of HbA1c target (<8% / <7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline weight (as continuous) and baseline weight-by-visit interaction.|Baseline, Month 6, Month 12|Analysis was performed on ITT population.|||kilogram (kg)||Standard Error|Least Squares Mean
2576803|NCT02447081|Secondary|Number of Participants With Oral Anti-coagulation Usage||At 12 months|The number of participates completing a study visit at the Time Frame|||Participants|||Count of Participants
2576476|NCT02451137|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Month 6 and Month 12|Change in FPG was calculated by subtracting baseline value from Month 6 and Month 12 values. Adjusted LS means and SE were obtained using MMRM model with fixed categorical effects of treatment arm, randomization strata of HbA1c target (<8% / <7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline FPG (as continuous) and baseline FPG-by-visit interaction.|Baseline, Month 6, Month 12|Analysis was performed on ITT population.|||mg/dL||Standard Error|Least Squares Mean
2576477|NCT02451137|Secondary|Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <=3.9 mmol/L (<= 70 mg/dL) and <3.0 mmol/L (< 54 mg/dL) and/or Severe Hypoglycemia During the 12-Month Randomized Period|HEDIS criteria for Individualized HbA1c target: <8% if age >= 65 years or presence of medical comorbidities, or otherwise <7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (<=70 mg/dL) and < 3.0 mmol/L (< 54 mg/dL).|Baseline to Month 12|Analysis was performed on ITT population.|||percentage of participants|||Number
2576478|NCT02451137|Secondary|Percentage of Participants Reaching Individualized HbA1c Target Without Documented Symptomatic <3.0 mmol/L (<54 mg/dL) and/or Severe Hypoglycemia During the 6-Month Randomized Period|HEDIS criteria for Individualized HbA1c target: <8% if age >= 65 years or presence of medical comorbidities, or otherwise <7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <54 mg/dL (3.0 mmol/L).|Baseline to Month 6|Analysis was performed on ITT population.|||percentage of participants|||Number
2576479|NCT02451137|Secondary|Treatment Persistence Measured by Medication Possession Ratio (MPR)|Treatment persistence was determined based on vendor claims database that would be responsible for managing and administration of the study drugs. Medication use was assessed by MPR and persistence measures based on data collected by the smart card vendor (date of fill or refill and quantity of medication dispensed for 30-day supply). The MPR was assessed based on total number of days of supply divided by the total number of days in 6 or 12 months period.|At Month 6 and Month 12|Analysis was performed on safety population.|||Medication Possession ratio||Standard Deviation|Mean
2576480|NCT02451137|Secondary|Change From Baseline in HbA1c at Month 6 and Month 12|Change in HbA1c was calculated by subtracting baseline value from Month 6 and Month 12 values. Adjusted Least Squares (LS) means and Standard Errors (SE) were obtained using Mixed Effect Model with Repeated Measures (MMRM ) with fixed categorical effects of treatment arm, visit, treatment arm-by-visit interaction, randomization strata of HbA1c target (<8% / <7%), SU use (yes/no), GLP-1 RA use (yes/no), as well as baseline HbA1c (as continuous) and baseline HbA1c-by-visit interaction.|Baseline, Month 6, Month 12|Analysis was performed on ITT population.|||percentage of HbA1c||Standard Error|Least Squares Mean
2576481|NCT02451137|Primary|Percentage of Participants With Individualized Glycated Hemoglobin Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria Without Documented Symptomatic(Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and/or Severe Hypoglycemia|HEDIS criteria: Individualized HbA1c target <8% if age >= 65 years or presence of medical comorbidities, or otherwise <7%. Severe hypoglycaemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycaemia was an event during which typical symptoms of hypoglycaemia were accompanied by a measured plasma glucose concentration of <=70 milligrams per deciliter (mg/dL) (<=3.9 millimoles per litre [mmol/L]). Analysis was performed using all post-baseline data available on the 6 month randomized period (defined as time from randomization up to Day 180 or discontinuation date, whichever comes earlier).|Baseline to Month 6|Analysis was performed on Intent-to-Treat (ITT) population which comprised of all randomized participants, irrespective of the treatment actually received, and analyzed according to the treatment group allocated by randomization.|||percentage of participants|||Number
2576482|NCT02451124|Primary|Average Methylation of Zinc Finger Protein 793 Assay|Average methylation of zinc finger protein 793 assay|Up to 7 months|Data not collected||||||
2576483|NCT02451124|Primary|Performance of the mVIM Assay in Balloon Brushings From Subjects Without BE|Performance of the mVIM assay in balloon brushings from subjects without BE|Up to 7 months|Data not collected||||||
2576484|NCT02451124|Primary|Average Methylation of Methylated Beta-1,3-glucuronyltransferase 2 Assays|Average methylation of methylated beta-1,3-glucuronyltransferase 2 assays|Up to 7 months|Data not collected||||||
2576485|NCT02451124|Primary|Specificity of the mVIM Assay in Balloon Brushings From Control Participants With no BE Diagnosis|Specificity of the mVIM assay in balloon brushings from control subjects with BE as measured by true negatives determined by biomarker (mVIM and mCCNA1) analyses of corresponding esophageal balloon derived samples compared to initial control status. The presence of at least 1% of methylated VIM in DNA extracted from the esophageal sampling balloon will be considered a positive assay.|Up to 1 year|Evaluable Controls. Controls were evaluable participants with with no diagnosed disease. Some controls not evaluable because of failure to swallow device, failure to obtain adequate DNA from balloon tips, or other exclusionary reasons.|||% specificity|||Number
2576486|NCT02451124|Primary|Sensitivity of the mVIM Assay in Balloon Brushings From Participants With BE|Sensitivity of the mVIM assay in balloon brushings from participants with BE as measured by true positives determined by biomarker (mVIM and mCCNA1) analyses of corresponding esophageal balloon derived samples compared to initial diagnosis. The presence of at least 1% of methylated VIM in DNA extracted from the esophageal sampling balloon will be considered a positive assay.|Up to 1 year|Evaluable Cases. Cases are participants with diagnosed BE. Some cases not evaluable because of failure to swallow device, failure to obtain adequate DNA from balloon tips, or other exclusionary reasons.|||% sensitivity|||Number
2576516|NCT02450539|Secondary|PK: Volume of Distribution of Abemaciclib|PK: Volume of Distribution of Abemaciclib|Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose|All participants who received Abemaciclib and had evaluable PK data.|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
2579903|NCT02412501|Secondary|Number of Participants With a Major Adverse Cardiac Event at 12 Months Post Procedure||12Months||||Participants|||Count of Participants
2576487|NCT02451124|Primary|Number of Participants Reporting Each Category of Tolerance Assessed by the Tolerance Survey|Mean tolerance score as assessed by 'tolerance survey' with scores ranging from 0 to 50 with higher scores indicating worse tolerance of interventional balloon device. Subscales include anxiety, pain, choking, gagging, and overall tolerance, with each domain scores ranging from 0 to 10, with higher scores indicating worse tolerance of interventional balloon device.|At completion of study procedure (up to 60 minutes)|Participants who were successfully able to swallow the device|||number of participants|||Number
2576488|NCT02451007|Secondary|Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Intercept)|"ΔQTcF (Change from Baseline in QT Corrected According to Fridericia's Formula); CI (Confidence Interval); Cmax (Maximum Plasma Concentration).~Table below details the results of the linear mixed effects model to quantify the relationship between the lurbinectedin plasma concentrations and ΔQTcF and Predicted ΔQTcF and 90% CI at mean lurbinectedin Cmax."|Through study completion, each patient had to be followed for 2 cycles (1 cycle =3 weeks)||||Unitless||90% Confidence Interval|Number
2576489|NCT02451007|Secondary|Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Predicted ΔQTcF)|"ΔQTcF (Change from Baseline in QT Corrected According to Fridericia's Formula); CI (Confidence Interval); Cmax (Maximum Plasma Concentration).~Table below details the results of the linear mixed effects model to quantify the relationship between the lurbinectedin plasma concentrations and ΔQTcF and Predicted ΔQTcF and 90% CI at mean lurbinectedin Cmax."|Through study completion, each patient had to be followed for 2 cycles (1 cycle =3 weeks)||||Milliseconds (ms)||90% Confidence Interval|Mean
2576490|NCT02451007|Secondary|Relationship Between ΔQTcF and Time-matched Lurbinectedin Plasma Concentrations (Plasma Concentration)|"ΔQTcF (Change from Baseline in QT Corrected According to Fridericia's Formula); CI (Confidence Interval); Cmax (Maximum Plasma Concentration).~Table below details the results of the linear mixed effects model to quantify the relationship between the lurbinectedin plasma concentrations and ΔQTcF and Predicted ΔQTcF and 90% CI at mean lurbinectedin Cmax."|Through study completion, each patient had to be followed for 2 cycles (1 cycle =3 weeks)||||Microgram/milliliter (μg/mL)||90% Confidence Interval|Mean
2576491|NCT02451007|Primary|Change in QTcF (QT Corrected According to Fridericia's Formula)|"ΔQTCF (Change in QTcF); EOI (end of infusion); LSM (Least Square Means); PK (Pharmacokinetic(s)).~On Day 1 (D1) of Cycle 1 (C1), LSM ΔQTcF should have low difference values, without any clear trend to change with time.~Therefore, the upper bound (UB) of the (two-sided) 90%Confidence Interval (CI) at all time points had to be less than the protocol-specified cut-off of 20 ms at each time point. If so, non-inferiority of any ECG time point to baseline with respect of QTc prolongation could be concluded"|Scheduled post-baseline ECG time points were taken 5-10 min before their time-matched PK samples: i.e., 5 min before EOI, 30 min, 1, 3, 24, 72 and 168 hours after EOI of Cycle 1, and 5 min before EOI, 30 min, 1, 3 and 168 hours after EOI of Cycle 2.||||ms (Milliseconds)||90% Confidence Interval|Least Squares Mean
2576492|NCT02450799|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit|Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity (at both near and distance). Visual Acuity (VA) is measured in logMAR (logarithm of the minimum angle of resolution). A lower logMAR value indicates better visual acuity. One eye (study eye) contributed to the analysis.|Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation)|This analysis population includes all subjects who used the study devices and have data after implantation of study devices (Full Analysis Set).|||logMAR||Standard Deviation|Mean
2576493|NCT02450747|Primary|Average Corneal Staining Area Grade|Corneal staining Area Grade was assessed in throughout five (5) regions in the eye (Central, Nasal, Temporal, Inferior, Superior). Corneal Staining was Graded using the Efron scale from 0 to 4 in 0.1 unit steps and converted to a percentage of region that was stained. The average percent of region that was stained was calculated and reported.|Baseline to 4- Week Follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||Average Percentage of Staining|Subject Eyes|Standard Deviation|Mean
2576494|NCT02450747|Primary|Upper Lid Margin Staining Score|Upper Lid Margin Staining was assessed using Fluorescein Staining and was measured on the Graded Scale is Grade 0: No Staining is present, Grade 1= 1% to 25% Stains, Grade 2= 26% to 50% Stains, Grade 3= 51% to 75% Stains, Grade 4 76% to 100% Stains. The percentage of eyes with upper lid margin staining for each Grade is reported.|Baseline to 4-Week Follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||percentage of eyes|Subject Eyes||Number
2576495|NCT02450747|Primary|The Total Grade of Conjunctival Hyperemia|Hyperemia (Redness) was assessed using two different parts of the eye, the Bulbar and the Limbal. Hypemeria was measured using the Efron Scale in 0.5 step units. Grade 0= No Findings, Grade 1= Slight, Grade 2= Mild , Grade 3= Moderate and Grade 4 = severe. Hypermia was assessed in four regions of the eye (Inferior, Nasal, Temporal and Superior). The total grade of Conjunctival Hypermia across all regions and grades is reported. The total grade can range from 0 to 8. Where a higher grade implies worsening conjunctival hypermia|Baseline to 4-Week Follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation. The analysis is conducted on subject eyes.|||units on a scale|Subject Eyes|Standard Deviation|Mean
2576496|NCT02450591|Primary|Feasibility as Measured by at Least Five Patients Will Need to Complete Local Therapy.|At least five patients will need to complete local therapy within 2 years of the study being open to accrual for the primary endpoint to be met.|2 years|Primary outcome accrual goal was not achieved. Data were not collected.||||||
2576497|NCT02450552|Secondary|Number of Participants Who Tolerate Study Drug|Participants will be judged tolerant of study drug if they reached their target dose and remain on study drug until planned discontinuation. Tolerability will be summarized as the proportion of participants in a treatment group who are tolerant of study drug.|10 weeks||||Participants|||Count of Participants
2576517|NCT02450539|Secondary|Pharmacokinetics (PK): Clearance of Abemaciclib|Pharmacokinetics (PK): Clearance of Abemaciclib|Cycle (C) 1 Day (D) 1: Pre-dose; C1D8: 4 and 7 hr Post-dose; C2D1: Pre-dose and 3 hr Post-dose; C3 and C4 D1:Pre-dose|All participants who received abemaciclib and had evaluable PK data.|||Liters/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2584035|NCT02359903|Secondary|Minimum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade||28 weeks|||||||
2576498|NCT02450552|Secondary|Proportion of Days With Fasciculations|For the purpose of this study, a fasciculation is a brief, spontaneous contraction affecting a small number of muscle fibers, often causing a flicker of movement under the skin. Defining interference with daily activities may be different for each subject and defining daily activities will be different for each subject. Subjects will self report by diary, days with fasciculations.|Week 1 through Week 10|Discrepancies in the number of subjects analyzed are a result of subjects with missed data collection during the specific time points.|||Proportion of Days||Standard Deviation|Mean
2576499|NCT02450552|Secondary|Hand Held Dynamometry Force Measurement for Abductor Pollicis Brevis|Hand held dynamometry (HHD) will be used as a quantitative measure of muscle strength of the abductor pollicis brevis (APB) muscle. HHD will be self-report by study participants using a daily muscle cramping diary.|Screening, Baseline, Week 4, Week 6, Week 8, Week 12|Discrepancies in the number of subjects analyzed are a result of subjects with missed data collection during the specific time points.|||kilograms (kg)||Standard Deviation|Mean
2576500|NCT02450552|Secondary|Muscle Cramping Frequency|Frequency of muscle cramping and maximum pain from muscle cramping was collected by subjects via self-report using a daily muscle cramping diary.|Week 1 through Week 10|Discrepancies in the number of subjects analyzed are a result of subjects with missed data collection during the specific time points.|||Days||Standard Deviation|Mean
2576501|NCT02450552|Secondary|Change in Recovery Cycle|Lower motor neuron excitability can be measured using change in recovery cycle of superexcitability. Change in recovery cycle of superexcitability after first pre-pulse is assessed by threshold tracking axonal nerve conduction studies (TTNCS). Threshold-tracking nerve conduction studies is a neurophysiologic test for assessing lower motor neuron function.|Screening, Baseline, Week 6, Week 8|Data of low quality were removed from analysis as a result of the central reader's evaluation standards.|||percentage of threshold||Standard Deviation|Mean
2576502|NCT02450552|Secondary|Change in Strength Duration Time Constant|Assessed by threshold tracking axonal nerve conduction studies (TTNCS).|Screening, Baseline, Week 6, Week 8|Data of low quality were removed from analysis population as a result of the central reader's evaluation standards.|||Milliseconds||Standard Deviation|Mean
2576503|NCT02450552|Secondary|Change in Electrotonus|Change in depolarizing electrotonus at 90 to 100 milliseconds was assessed by threshold tracking axonal nerve conduction studies (TTNCS). TTNCS is a neurophysiologic test for assessing lower motor neuron function.|Screening, Baseline, Week 6, Week 8|Data of low quality were removed from analysis population as a result of the central reader's evaluation standards.|||percentage of threshold||Standard Deviation|Mean
2576504|NCT02450552|Secondary|Change in Intracortical Facilitation|Paired-pulse Intracortical facilitation (ICF) is defined as the ratio of the response after a conditioning pulse equal to 80% of Resting Motor Threshold (RMT) is administered 15 milliseconds prior to the signaling pulse divided by Motor Evoked Potential (MEP) amplitude. ICF is calculated as the geometric mean of replicate estimates. Change in intracortical facilitation is assessed by Transcranial Magnetic Stimulation (TMS).|Screening, Baseline, Week 6, Week 8|Data of low quality were removed from analysis population as a result of the central reader's evaluation standards.|||Unitless||Standard Deviation|Geometric Mean
2576505|NCT02450552|Secondary|Change in Duration of Cortical Silent Period|Cortical silent period (CSP) is the suppression of voluntary muscle contraction elicited by stimulation equal to 120% of resting motor threshold (RMT). CSP duration is measured from the time of the muscle activity suppression to return of muscle activity. Change in duration of cortical silent period is assessed by Transcranial Magnetic Stimulation (TMS).|Screening, Baseline, Week 6, Week 8|Data of low quality were removed from analysis population as a result of the central reader's evaluation standards.|||Milliseconds||Standard Deviation|Mean
2576506|NCT02450552|Secondary|Change in MEP Amplitude|Motor Evoked Potential (MEP) amplitude is defined as the response when a stimulus equal to 120% of Resting Motor Threshold (RMT) is administered. MEP amplitude is calculated as the geometric mean of replicate estimates. Change in MEP will be assessed by Transcranial Magnetic Stimulation (TMS).|Screening, Baseline, Week 6, Week 8|Data of low quality were removed from analysis as a result of the central reader's evaluation standards.|||Millivolts||Standard Deviation|Geometric Mean
2576507|NCT02450552|Secondary|Change in Resting Motor Evoked Potential (MEP) Threshold (Prespecified Secondary Outcome of Primary Importance)|Resting Motor Evoked Potential (MEP) is the magnetic field strength, measured as a percentage of the maximum stimulator output, that produces at least a 0.05 mV response in at least 5 of 10 consecutive trials.Change in resting MEP threshold will be assessed by Transcranial Magnetic Stimulation (TMS).|Screening, Baseline, Week 6, Week 8|Data of low quality may have been removed from the number of participants analyzed based on the central reader's evaluation.|||percentage of the maximum output||Standard Deviation|Mean
2576508|NCT02450552|Primary|Change in Short-interval Intracortical Inhibition (SICI) Measured by Transcranial Magnetic Stimulation (TMS)|Short-interval intracortical inhibition (SICI) or paired-pulse SICI is defined as the ratio of the response after a conditioning pulse equal to 80% of resting motor threshold (RMT) is administered 3 ms prior to the signaling pulse divided by motor evoked potential (MEP) amplitude. Transcranial magnetic stimulation (TMS) is a neurophysiologic test for assessing upper motor neuron function. Change in SICI will be assessed by transcranial magnetic stimulation (TMS) after treatment with 900 mg/day or 600 mg/day of ezogabine vs. matched oral placebo.|Screening, Baseline, Week 6, Week 8|As a result of electrophysiologic response, good quality data was defined based on the central reader's evaluation.|||Unitless||Standard Deviation|Mean
2576518|NCT02450539|Primary|Progression Free Survival (PFS)|PFS was defined as time from the date of randomization to the date of investigator-determined disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, with reference the smallest sum on study and an absolute increase of at least 5mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant was not known to have died or have objective progression, PFS time will be censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available.|Baseline to Objective Progression or Death from Any Cause ( Up To 6 Months)|All participants according to the treatment group to which they were randomized. Participants censored: Abemaciclib=19 and Docetaxel= 15.|||months||95% Confidence Interval|Median
2584036|NCT02359903|Secondary|Maximum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade||28 weeks|||||||
2576509|NCT02450539|Secondary|Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire Index Value|There are 5 response levels on a good-to-bad continuum of 1-5 corresponding to none, slight, moderate, severe, and extreme/unable to.The EuroQol-developed crosswalk method was used to convert the EQ-5D-5L,using UK weights,health dimensions(mobility,self-care,usual activities,pain/discomfort, and anxiety/depression) into a single index value;the dimensions are not separately scored.The index is marked missing when ≥1 dimensions are missing.The index scores for the response patterns were anchored on full health to dead with negative values assigned to response patterns/health states considered worse than death.The best pattern is assigned the index value of 1.0; the worst pattern is assigned an index value of -0.594. Between-group differences in regression-predicted change from baseline score were estimated for the index .MMRM models included independent variables treatment, visit, treatment*visit, and baseline score.Group-level negative change from baseline indicated group improvement.|Baseline to Measured Progressive Disease (Up To 6 Months)|All randomized participants for cycles which at least 25% of participants in each arm have a score.The EQ-5D-5L population included all randomized participants who completed at least 1 baseline assessment followed by at least 1 EQ-5D-5L assessment after Cycle 1 (for example, a completed EQ-5D-5L questionnaire at Cycle 2 Day 1 or later).|||units on a scale||Standard Error|Least Squares Mean
2576510|NCT02450539|Secondary|Change From Baseline in EuroQol 5-Dimensional 5-Level (EQ-5D-5L) Questionnaire EQ VAS Overall Self-rated Health Score|The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Overall self-rated health was measured with a vertical 20 cm visual analog scale (VAS) anchored at 0 (worst health) and ranged through 100 (best health). Between-group differences in regression-predicted change from baseline score were estimated for VAS scores. MMRM models included independent variables treatment, visit, treatment*visit, and baseline score. Group-level negative change from baseline indicated group improvement.|Baseline to Measured Progressive Disease (Up To 6 Months)|All randomized participants for cycles which at least 25% of participants in each arm have a score.The EQ-5D-5L population included all randomized participants who completed at least 1 baseline assessment followed by at least 1 EQ-5D-5L assessment after Cycle 1 (for example, a completed EQ-5D-5L questionnaire at Cycle 2 Day 1 or later).|||units on a scale||Standard Error|Least Squares Mean
2576511|NCT02450539|Secondary|Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Scores|MDASI-LC included 33 items:6 interference and 27 symptom(3 lung-cancer (LC),8 brain tumor (BT),and 3 study-specific(headache,diarrhea, and rash).Analyzed endpoints were 9 constructs:3 single-items (headache,diarrhea,and rash) and 6 composites(interference+core,LC,core+LC,BT, and core+LC worst 5 baseline).Data for all 9 constructs were collected by an 11-point numeric rating scale anchored at 0(not present or does not interfere) and 10(as bad as you can imagine or interfered completely).The measurement range was 10 (maximum score-minimum score). Between-group difference in regression-predicted change from baseline were estimated for each specified construct. MMRM models included independent variables treatment,visit, treatment*visit,and baseline score. Group-level negative change from baseline indicated group improvement.|Baseline through End of Study (Up To 6 Months)|All randomized participants for cycles which at least 25% of participants in each arm have a score.MDASI-LC population included all randomized participants who completed at least 1 baseline assessment followed by at least 1 MDASI-LC assessment after Cycle 1 (for example, a completed MDASI-LC questionnaire at Cycle 2 Day 1 or later)|||units on a scale||Standard Error|Least Squares Mean
2576512|NCT02450539|Secondary|Time to Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status of >/=2|"Worsening of ECOG performance status is the duration from randomization to ECOG PFS of >/=2. Participants without an ECOG PFS >/=2 are censored at last adequate post baseline ECOG Performance Status or randomization date (whichever is last).~The ECOG Performance Status:0 - Fully active, able to carry on all pre-disease performance without restriction,1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours,3 - Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4 - Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair, 5 - Dead"|Randomization to ECOG PFS of >/=2 (Up To 11.5 Months)|All randomized participants. Participants censored: Abemaciclib =93 and Docetaxel= 43.|||months||95% Confidence Interval|Median
2576513|NCT02450539|Secondary|Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR): Disease Control Rate (DCR)|DCR is the percentage of randomized participants who achieved a complete response, partial response or stable disease using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Complete response (CR) is defined as the disappearance of all target and non-target lesions, and no appearance of new lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions. Stable disease was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.|Baseline through Measured Progressive Disease or Death Due to Any Cause (Up To 6 Months)|All randomized participants.|||percentage participants|||Number
2576514|NCT02450539|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])|Overall response was defined as the percentage of randomized participants achieving a best overall response (BoR) of complete response (CR) or partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. Participants with unevaluable or unknown response status are considered nonresponders. Complete response (CR) is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions and no appearance of new lesions.|Baseline to Objective Progression (Up To 6 Months)|All randomized participants.|||percentage participants|||Number
2576515|NCT02450539|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death due to any cause. For each participant who is not known to have died as the data inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.|Baseline to Date of Death from Any Cause (Approximately 11 Months)||2021-08-31|08/2021||||
2576804|NCT02447081|Secondary|Number of Participants With Oral Anti-coagulation Usage||At 6 months|The number of participates completing a study visit at the Time Frame|||Participants|||Count of Participants
2576519|NCT02450526|Other Pre-specified|Mean Change From Baseline in Subject's Self-Perception of Age at All Study Visits (OL Period)|"At cycle baseline (Day 1 of each treatment cycle) and Day 29 of each cycle in the OL period, subjects were asked to evaluate their age over the past 7 days at the time of assessment, using the following categories:~I look like my current age;~I look _ years younger;~I look _ years older.~The mean change from cycle baseline in subject's self-perception of age at Day 29 of each cycle of the OL Period was calculated. A negative mean change from baseline in the subject's self-perception of age indicates that the subject's self-perception was to look younger compared with baseline."|Up to Cycle 5, Day 29.|The OL population was all randomised subjects who received any dose of OL Dysport®. Only subjects with data available for analysis is presented.|||years||Standard Deviation|Mean
2576520|NCT02450526|Other Pre-specified|The Proportion of Responders With Respect to the SGA Score at All Other Study Visits (OL Period).|"On each study visit per treatment cycle in the OL period, subjects were asked to assess the change, since the last treatment administration, in the appearance of their glabellar lines using the following 9-point Global Assessment Scale: +4 =100% improvement; +3 =75% improvement; +2 =50% improvement; +1 =25% improvement; 0 =no change; -1 =25% worsening; -2 =50%worsening; -3 =75% worsening; -4 =100% worsening.~A responder, based on the SGA scale, was defined as having a grade of at least +2 (50% improvement). The proportion (percentage) of responders at each study visit on Day 8 to Day 85 in the OL period is presented."|Up to Cycle 5, Day 85.|The OL population was all randomised subjects who received any dose of OL Dysport®. Only subjects with data available for analysis at each time point are presented.|||percentage of responders||95% Confidence Interval|Number
2576521|NCT02450526|Other Pre-specified|Mean SGA Score at All Other Study Visits (OL Period).|"On each study visit per treatment cycle in the OL period, subjects were asked to assess the change, since the last treatment administration, in the appearance of their glabellar lines using the following 9-point Global Assessment Scale: +4 =100% improvement; +3 =75% improvement; +2 =50% improvement; +1 =25% improvement; 0 =no change; -1 =25% worsening; -2 =50%worsening; -3 =75% worsening; -4 =100% worsening.~The mean SGA score for study visits on Day 8 to Day 85 in the OL period is presented."|Up to Cycle 5, Day 85.|The OL population was all randomised subjects who received any dose of OL Dysport®. Only subjects with data available for analysis at each time point are presented.|||units on the SGA scale||Standard Deviation|Mean
2576522|NCT02450526|Other Pre-specified|The Percentage of Responders Measured by the ILA at Rest at All Study Visits (OL Period).|At baseline (Cycle 1, Day 1) and all subsequent study visits per treatment cycle in the OL period, the Investigator assessed the appearance of the glabellar lines at rest using a validated 4-point Photographic Scale of Glabellar Line Severity. This 4-point scale rated the severity of glabellar lines as Grade 0 (none), Grade 1 (mild), Grade 2 (moderate) and Grade 3 (severe). A responder was defined as having a severity grade of 0 or 1 at a given visit, and a severity grade of 2 or 3 at baseline. Subjects with a baseline score of 0 or 1 were excluded from the analysis of responders. The proportion (percentage) of responders measured by ILA at all study visits per treatment cycle in in the OL period is presented.|Up to Cycle 5, Day 85.|The OL population was all randomised subjects who received any dose of OL Dysport®. Only subjects with a baseline score of 2 or 3 and with data available for analysis at each time point are presented.|||percentage of responders||95% Confidence Interval|Number
2576523|NCT02450526|Other Pre-specified|The Percentage of Responders Measured by the SSA at Maximum Frown at All Other Study Visits (OL Period).|"At baseline (Cycle 1, Day 1) and all subsequent study visits per treatment cycle in the OL period, subjects assessed the appearance of their glabellar lines at maximum frown using a 4-point categorical scale. The 4-point scale represents the severity of glabellar lines as Grade 0 (no wrinkles), Grade 1 (mild wrinkles), Grade 2 (moderate wrinkles) and Grade 3 (severe wrinkles). For the SSA, a responder was defined as having a severity grade of no wrinkles (0) or mild wrinkles (1) at maximum frown at a given visit and a severity grade of moderate wrinkles (2) or severe wrinkles (3) at maximum frown at baseline.~The proportion (percentage) of responders measured by SSA at all study visits in Cycle 2 to 5 is presented."|Up to Cycle 5, Day 85.|The OL population was all randomised subjects who received any dose of OL Dysport®. Only subjects with data available for analysis at each time point are presented.|||percentage of responders||95% Confidence Interval|Number
2576524|NCT02450526|Other Pre-specified|The Percentage of Responders Measured by the ILA at Maximum Frown at All Other Study Visits (OL Period).|"At baseline (Cycle 1, Day 1) and all subsequent study visits (per treatment cycle) in the OL period, the Investigator assessed the appearance of the glabellar lines at maximum frown using a validated 4-point Photographic Scale of Glabellar Line Severity. This 4-point scale rated the severity of glabellar lines as Grade 0 (none), Grade 1 (mild), Grade 2 (moderate) and Grade 3 (severe). A responder was defined as having a severity grade of 0 or 1 at each study visit, and a severity grade of 2 or 3 at baseline.~The proportion (percentage) of responders measured by ILA at all study visits in each treatment cycle, is presented."|Up to Cycle 5, Day 85.|The OL population was all randomised subjects who received any dose of OL Dysport®. Only subjects with data available for analysis at each time point are presented.|||percentage of responders||95% Confidence Interval|Number
2576525|NCT02450526|Other Pre-specified|The Time to Onset of Treatment Response Based on the Subject's Diary Card (DB Period).|"Subjects were given the diary card at baseline (Cycle 1, Day 1 ) and asked to record their assessment of study treatment response for the first 7 days post-treatment (Days 2 to 8). They were asked to respond 'yes' or 'no' to the following question: 'Since being injected have you noticed an improvement in the appearance of your glabellar lines (lines between your eyebrows)?' Subjects with no treatment response were censored at the date of last assessment of treatment response recorded in the diary card.~The 50th percentile of Kaplan-Meier estimates was used to estimate the median time to onset of treatment response for each treatment group."|At Cycle 1, Day 8.|The mITT population was all randomised subjects who received study treatment in at least one injection site regardless of the amount administered and had both the baseline and Cycle 1, Day 29 assessments, for the ILA and SSA of glabellar lines at maximum frown. Only subjects with treatment response on Cycle 1, Day 8 were analysed.|||days||95% Confidence Interval|Median
2576589|NCT02449291|Secondary|Number of Participants With Complete Response 0-2 Hrs|Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes to 2 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 2-hour period after administration of study medication.|0-2 hours after administration of study medication||||Participants|||Count of Participants
2576526|NCT02450526|Other Pre-specified|Least Squares (LS) Mean Change From Baseline in Subject's Self-perception of Age at Cycle 1 Study Visits (DB Period).|"At baseline (Cycle 1, Day 1) and all subsequent study visits in Cycle 1, subjects were asked to evaluate their age over the past 7 days at the time of assessment, using the following categories:~I look like my current age;~I look _ years younger;~I look _ years older.~The LS mean change from baseline in subject's self-perception of age at all study visits in the DB Period was calculated. A negative LS mean change from baseline in the subject's self-perception of age indicates that the subject's self-perception was to look younger compared with baseline."|Up to Cycle 1, Day 85.|The mITT population was all randomised subjects who received study treatment in at least one injection site regardless of the amount administered and had both the baseline and Cycle 1, Day 29 assessments, for the ILA and SSA of glabellar lines at maximum frown. Only subjects with data available for analysis at each time point is presented.|||years||Standard Error|Least Squares Mean
2576527|NCT02450526|Other Pre-specified|The Percentage of Responders With Respect to the SGA Score at Cycle 1 Study Visits (DB Period).|"On all study visits, subjects were asked to assess the change, since the last treatment administration, in the appearance of their glabellar lines using the following 9-point Global Assessment Scale: +4 =100% improvement; +3 =75% improvement; +2 =50% improvement; +1 =25% improvement; 0 =no change; -1 =25% worsening; -2 =50%worsening; -3 =75% worsening; -4 =100% worsening. A responder, based on the SGA scale, was defined as having a grade of at least +2 (50% improvement).~Superiority analysis of active treatment versus placebo was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for all visits up to Day 85 in the DB period (except Cycle 1, Day 29)."|Up to Cycle 1, Day 85.|The mITT population was all randomised subjects who received study treatment in at least one injection site regardless of the amount administered and had both the baseline and Cycle 1, Day 29 assessments, for the ILA and SSA of glabellar lines at maximum frown. Only subjects with data available for analysis at each time point are presented.|||adjusted percentage of responders||95% Confidence Interval|Number
2576528|NCT02450526|Other Pre-specified|Mean SGA Score at Cycle 1 Study Visits (DB Period).|"On all study visits, subjects were asked to assess the change, since the last treatment administration, in the appearance of their glabellar lines using the following 9-point Global Assessment Scale: +4 =100% improvement; +3 =75% improvement; +2 =50% improvement; +1 =25% improvement; 0 =no change; -1 =25% worsening; -2 =50% worsening; -3 =75% worsening; -4 =100% worsening.~The mean SGA score for study visits on Day 8 to Day 85 in the DB period is presented (except Cycle 1, Day 29)."|Up to Cycle 1, Day 85.|The mITT population was all randomised subjects who received study treatment in at least one injection site regardless of the amount administered and had both the baseline and Cycle 1, Day 29 assessments, for the ILA and SSA of glabellar lines at maximum frown. Only subjects with data available for analysis at each time point are presented.|||units on the SGA scale||Standard Deviation|Mean
2576529|NCT02450526|Other Pre-specified|The Percentage of Responders With Respect to Independent Reviewer's Assessment of Photographs of the Subject's Glabellar Lines at Maximum Frown at Cycle 1, Day 85 (DB Period).|"Photographs of the glabellar region of subjects were taken at baseline and at maximum frown at Cycle 1, Day 85. Photographs were assessed by an Independent Experts Committee using a validated 4-point Photographic Scale of Glabellar Line Severity. This 4-point scale rated the severity of glabellar lines as Grade 0 (none), Grade 1 (mild), Grade 2 (moderate) and Grade 3 (severe). The median of 3 readings by 3 independent reviewers was used in the analysis. A responder was defined as having a severity grade of 0 or 1 at Cycle 1, Day 85, and a severity grade of 2 or 3 at baseline.~Superiority analysis of active treatment versus placebo was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for Cycle 1, Day 85 ."|At Cycle 1, Day 85.|The mITT population was all randomised subjects who received study treatment in at least one injection site regardless of the amount administered and had both the baseline and Cycle 1, Day 29 assessments, for the ILA and SSA of glabellar lines at maximum frown. Subjects with a baseline score of 0 or 1 were excluded from the analysis.|||adjusted percentage of responders||95% Confidence Interval|Number
2576530|NCT02450526|Other Pre-specified|The Percentage of Responders Measured by the ILA at Rest at Cycle 1 Study Visits (DB Period).|"At baseline (Cycle 1, Day 1) and at all subsequent study visits, the Investigator assessed the appearance of the glabellar lines at rest using a validated 4-point photographic scale of glabellar line severity. This 4-point scale rated the severity of glabellar lines as Grade 0 (none), Grade 1 (mild), Grade 2 (moderate) and Grade 3 (severe). A responder was defined as having a severity grade of 0 or 1 at rest at any given visit, and a severity grade of 2 or 3 at rest at baseline.~Superiority analysis of active treatment versus placebo was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for all visits up to Day 85 in the DB period (except Cycle 1, Day 29)."|Up to Cycle 1, Day 85.|The mITT population was all randomised subjects who received study treatment in at least one injection site regardless of the amount administered and had both the baseline and Cycle 1, Day 29 assessments, for the ILA and SSA of glabellar lines at maximum frown. Subjects with a baseline score of 0 or 1 were excluded from the analysis of responders.|||adjusted percentage of responders||95% Confidence Interval|Number
2576537|NCT02450526|Primary|Superiority Analysis of The Percentage of Responders Measured by the SSA at Maximum Frown at Cycle 1, Day 29 (DB Period).|"At baseline (Cycle 1, Day 1) and at Cycle 1, Day 29, subjects assessed the appearance of their glabellar lines at maximum frown using a 4-point categorical scale. The 4-point scale represents the severity of glabellar lines as Grade 0 (no wrinkles), Grade 1 (mild wrinkles), Grade 2 (moderate wrinkles) and Grade 3 (severe wrinkles). For the SSA, a responder was defined as having a severity grade of 0 or 1 at maximum frown at Cycle 1, Day 29, and a severity grade of 2 or 3 at maximum frown at baseline.~Superiority analysis of active treatment versus placebo was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for Cycle 1, Day 29."|At Cycle 1, Day 29.|The mITT population was all randomised subjects who received study treatment in at least one injection site regardless of the amount administered and had both the baseline and Cycle 1, Day 29 assessments, for the ILA and SSA of glabellar lines at maximum frown.|||adjusted percentage of responders||95% Confidence Interval|Number
2576531|NCT02450526|Other Pre-specified|The Percentage of Responders Measured by the SSA at Maximum Frown at Cycle 1 Study Visits (DB Period).|"At baseline (Cycle 1, Day 1) and all subsequent study visits, subjects assessed the appearance of their glabellar lines at maximum frown using a 4-point categorical scale. The 4-point scale represents the severity of glabellar lines as Grade 0 (no wrinkles), Grade 1 (mild wrinkles), Grade 2 (moderate wrinkles) and Grade 3 (severe wrinkles). For the SSA, a responder was defined as having a severity grade of 0 or 1 at maximum frown at any given visit, and a severity grade of 2 or 3 at maximum frown at baseline.~Superiority analysis of active treatment versus placebo was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for all visits up to Day 85 in the DB period (except Cycle 1, Day 29)."|Up to Cycle 1, Day 85.|The mITT population was all randomised subjects who received study treatment in at least one injection site regardless of the amount administered and had both the baseline and Cycle 1, Day 29 assessments, for the ILA and SSA of glabellar lines at maximum frown.|||adjusted percentage of responders||95% Confidence Interval|Number
2576532|NCT02450526|Other Pre-specified|The Percentage of Responders Measured by the ILA at Maximum Frown at Cycle 1 Study Visits (DB Period).|"At baseline (Cycle 1, Day 1) and at all subsequent study visits, the Investigator assessed the appearance of the glabellar lines at maximum frown using a validated 4-point photographic scale of glabellar line severity. This 4-point scale rated the severity of glabellar lines as Grade 0 (none), Grade 1 (mild), Grade 2 (moderate) and Grade 3 (severe). A responder was defined as having a severity grade of 0 or 1 at any given visit, and a severity grade of 2 or 3 at baseline.~Superiority analysis of active treatment versus placebo was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for all visits up to Day 85 in the DB period (except Cycle 1, Day 29)."|Up to Cycle 1, Day 85.|The mITT population was all randomised subjects who received study treatment in at least one injection site regardless of the amount administered and had both the baseline and Cycle 1, Day 29 assessments, for the ILA and SSA of glabellar lines at maximum frown. Only subjects with data available for analysis at each time point are presented.|||adjusted percentage of responders||95% Confidence Interval|Number
2576533|NCT02450526|Secondary|The Percentage of Responders With Respect to the SGA Score at Cycle 1, Day 29 (DB Period).|"On Cycle 1, Day 29, subjects were asked to assess the change, since the last treatment administration, in the appearance of their glabellar lines using the following 9-point Global Assessment Scale: +4 =100% improvement; +3 =75% improvement; +2 =50% improvement; +1 =25% improvement; 0 =no change; -1 =25% worsening; -2 =50% worsening; -3 =75% worsening; -4 =100% worsening. A responder, based on the SGA scale, was defined as having a grade of at least +2 (50% improvement).~Superiority analysis of active treatment versus placebo was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for Cycle 1, Day 29."|At Cycle 1, Day 29.|The mITT population was all randomised subjects who received study treatment in at least one injection site regardless of the amount administered and had both the baseline and Cycle 1, Day 29 assessments, for the ILA and SSA of glabellar lines at maximum frown.|||adjusted percentage of responders||95% Confidence Interval|Number
2576534|NCT02450526|Secondary|Mean Subject's Global Assessment (SGA) Score at Cycle 1, Day 29 (DB Period).|"On Cycle 1, Day 29, subjects were asked to assess the change, since the last treatment administration, in the appearance of their glabellar lines using the following 9-point Global Assessment Scale: +4 =100% improvement; +3 =75% improvement; +2 =50% improvement; +1 =25% improvement; 0 =no change; -1 =25% worsening; -2 =50%worsening; -3 =75% worsening; -4 =100% worsening.~The mean SGA score at Cycle 1, Day 29 is presented."|At Cycle 1, Day 29.|The mITT population was all randomised subjects who received study treatment in at least one injection site regardless of the amount administered and had both the baseline and Cycle 1, Day 29 assessments, for the ILA and SSA of glabellar lines at maximum frown.|||units on the SGA scale||Standard Deviation|Mean
2576535|NCT02450526|Secondary|The Percentage of Responders With Respect to Independent Reviewer's Assessment of Photographs of the Subject's Glabellar Lines at Maximum Frown at Cycle 1, Day 29 (DB Period).|"Photographs of the glabellar region of subjects were taken at maximum frown at baseline (Cycle 1, Day 1) and at Cycle 1, Day 29. Photographs were assessed by an Independent Experts Committee using a validated 4-point Photographic Scale of Glabellar Line Severity which rated the severity of glabellar lines as Grade 0 (none), Grade 1 (mild), Grade 2 (moderate) and Grade 3 (severe). The median of three readings by three independent reviewers was used in the analysis. A responder was defined as having a severity grade of 0 or 1 at Cycle 1, Day 29, and a severity grade of 2 or 3 at baseline.~Superiority analysis of active treatment to placebo was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for Cycle 1, Day 29."|At Cycle 1, Day 29.|The mITT population was all randomised subjects who received study treatment in at least one injection site regardless of the amount administered and had both the baseline and Cycle 1, Day 29 assessments, for the ILA and SSA of glabellar lines at maximum frown. Subjects with a baseline score of 0 or 1 are excluded from the analysis.|||adjusted percentage of responders||95% Confidence Interval|Number
2576536|NCT02450526|Primary|Non-Inferiority Analysis of The Percentage of Responders Measured by the Investigator's Live Assessment (ILA) at Maximum Frown at Cycle 1, Day 29 (DB Period).|"At baseline (Cycle 1, Day 1) and at Cycle 1, Day 29, the Investigator assessed the appearance of the glabellar lines at maximum frown using a validated 4-point Photographic Scale of Glabellar Line Severity. This 4-point scale rated the severity of glabellar lines as Grade 0 (none), Grade 1 (mild), Grade 2 (moderate) and Grade 3 (severe). A responder was defined as having a severity grade of 0 or 1 at Cycle 1, Day 29, and a severity grade of 2 or 3 at maximum frown at baseline.~Non Inferiority analysis of Dysport® versus Botox was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for Cycle 1, Day 29."|At Cycle 1, Day 29.|The mITT population was all randomised subjects who received study treatment in at least one injection site regardless of the amount administered and had both the baseline and Cycle 1, Day 29 assessments, for the ILA and SSA of glabellar lines at maximum frown.|||adjusted percentage of responders||95% Confidence Interval|Number
2576538|NCT02450526|Primary|Superiority Analysis of The Percentage of Responders Measured by the Investigator's Live Assessment (ILA) at Maximum Frown at Cycle 1, Day 29 (DB Period).|"At baseline (Cycle 1, Day 1) and at Cycle 1, Day 29, the Investigator assessed the appearance of the glabellar lines at maximum frown using a validated 4-point Photographic Scale of Glabellar Line Severity. This 4-point scale rated the severity of glabellar lines as Grade 0 (none), Grade 1 (mild), Grade 2 (moderate) and Grade 3 (severe). A responder was defined as having a severity grade of 0 or 1 at Cycle 1, Day 29, and a severity grade of 2 or 3 at maximum frown at baseline.~Superiority analysis of active treatment versus placebo was carried out using a multivariate logistic regression model and adjusted for the stratification factors of gender and baseline severity score of glabellar lines at maximum frown measured by the ILA. The adjusted percentage of responders is presented for Cycle 1, Day 29."|At Cycle 1, Day 29.|The modified Intent-to-treat (mITT) population was all randomised subjects who received study treatment in at least one injection site regardless of the amount administered and had both the baseline and Cycle 1, Day 29 assessments, for the ILA and subjects' self assessment (SSA) of glabellar lines at maximum frown.|||adjusted percentage of responders||95% Confidence Interval|Number
2576539|NCT02450383|Secondary|Wound Healing, Measured Using a Standardized Visual Wound Healing Index|Wound healing status was evaluated by the same calibrated clinician using a standardized visual wound healing index at different time points A simple wound healing scoring system including 3 categories was used: 1- uneventful wound healing, 2- slight gingival edema, erythema or discomfort, 3- poor wound healing|2 weeks||||units on a scale||Standard Deviation|Mean
2576540|NCT02450383|Secondary|Patient-perceived Discomfort, Measured by VAS|Patient-reported outcome measures of perceived discomfort using a visual analog scale (VAS) from 0 (no pain) to 100 (maximum pain) were recorded|2 weeks||||units on a scale||Standard Deviation|Mean
2576541|NCT02450383|Secondary|Changes in Peri-implant Keratinized Mucosa Width (Apico-coronal) at 16 Weeks After Surgery||Baseline to 16 weeks after baseline||||millimeters||Standard Deviation|Mean
2576542|NCT02450383|Primary|Change in Buccal Peri-implant Mucosa Thickness Between Baseline and 16 Weeks After Surgery|Buccal mucosa thickness measurements were obtained by a calibrated, masked examiner using a custom-made stent and an endo file for precision and reproducibility between different time points|Baseline and 16 weeks after baseline||||millimeters||Standard Deviation|Mean
2576543|NCT02449915|Primary|Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively|VAS is a validated 100 millimeter scale with no pain as 0 mm and worst pain as 100 mm. Subjects drew a vertical line on the scale corresponding to their pain level.|18 hours after surgery||||mm||Inter-Quartile Range|Median
2576544|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Secretions)|Outcome was measured by using a severity scale. No Atrophy has normal clear secretions noted on vaginal walls(0). Mild atrophy has superficial coating of secretions, difficulty with speculum insertion(1). Moderate atrophy is scant not covering the entire vaginal vault, may need lubrication with speculum insertion to prevent pain(2). Severe atrophy has none, inflamed, ulceration noted, need lubrication with speculum insertion to prevent pain(3).|Baseline to 15 days post-treatment|All participants receiving at least one day of study medication.|||units on a scale||Standard Error|Least Squares Mean
2576545|NCT02449902|Primary|Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Epithelial Surface Thickness)|Outcome was measured by using a severity scale. No Atrophy has rogation and elasticity of vault(0). Mild atrophy has poor rogation with some elasticity noted of vaginal vault(1). Moderate atrophy is smooth, some elasticity of vaginal vault(2). Severe atrophy is smooth, no elasticity, constriction of the upper one third of vagina or loss of vaginal tone (cystocele and rectocele)(3).|Baseline to 15 days post-treatment|All participants receiving at least one day of study medication.|||units on a scale||Standard Error|Least Squares Mean
2576546|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Epithelial Integrity)|Outcome was measured by using a severity scale. No Atrophy=normal(0). Mild atrophy=vaginal surface bleeds with scraping(1). Moderate atrophy=vaginal surface bleeds with light contact(2). Severe atrophy=vaginal surface has petechiae before contact and bleeds with light contact(3).|Baseline to 15 days post-treatment|All participants receiving at least one day of study medication.|||units on a scale||Standard Error|Least Squares Mean
2576547|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Investigator Assessment of the Vaginal Mucosa (Assessment of Vaginal Color)|Outcome was measured by using a severity scale. No Atrophy is pink in color (0). Mild atrophy is lighter in color (1). Moderate atrophy is pale in color (2). Severe atrophy is transparent, either no color or inflamed (3).|Baseline to 15 days post-treatment|All participants receiving at least one day of study medication.|||units on a scale||Standard Error|Least Squares Mean
2576548|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Vaginal Bleeding Associated With Sexual Activity|Total number (N=10) of participants analyzed within each treatment group who were sexually active at both Baseline and Day 15 and provided a response at both visits.|Baseline to 15 days post-treatment|Total number (N=10) of participants analyzed within each treatment group who were sexually active at both Baseline and Day 15 and provided a response at both visits.|||participants|||Number
2576549|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Severity of the Most Bothersome Vulvar and Vaginal Atrophy (VVA) Symptom|The severity of the most bothersome VVA symptom was self-assessed by each subject using a VVA questionnaire. The questionnaire has a 4-point scoring scale with: None=0, Mild=1, Moderate=2, and Severe=3. The lower the score, the least bothersome it is to the subject.|Baseline to 15 days post-treatment||||units on a scale||Standard Error|Least Squares Mean
2576550|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Vaginal pH||Baseline to 15 days post-treatment||||pH||Standard Error|Least Squares Mean
2576551|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Intermediate Cells)||Baseline to 15 days post-treatment||||Percentage of Intermediate Cells||Standard Error|Least Squares Mean
2576552|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Superficial Cells)||Baseline to 15 days post-treatment||||Percentage of Superficial Cells||Standard Error|Least Squares Mean
2576553|NCT02449902|Primary|Analysis of Change From Baseline to Day 15 in Maturation Index of the Vaginal Cell Type (Parabasal Cells)||Baseline to 15 days post-treatment||||Percentage of Parabasal Cells||Standard Error|Least Squares Mean
2576554|NCT02449889|Secondary|Intensity of AEs|The intensity of an TEAE would be classified using the following 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity [disturbing]) or severe (inability to work or perform usual activities [unacceptable]).|AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented.|Safety was summarized based on the safety analysis set.The safety analysis set included all 176 subjects. Subjects were analyzed according to their actual treatment.|||Participants|||Count of Participants
2576555|NCT02449889|Secondary|Frequency of Adverse Events (AEs)|The number of treatment-emergent AEs (TEAEs) in each treatment group will be presented.|AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented|Safety was summarized based on the safety analysis set.The safety analysis set included all 176 subjects. Subjects were analyzed according to their actual treatment.|||Number of AEs|||Number
2576556|NCT02449889|Secondary|Clinical Pregnancy Rate|Defined as percentage of subjects with clinical pregnancy. Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer.|5-6 weeks after transfer|The ITT analysis set was defined as all randomized subjects. Subjects were analyzed according to planned (randomized) treatment.|||percentage of participants|||Number
2576557|NCT02449889|Secondary|Positive β Unit of Human Chorionic Gonadotropin (βhCG) Rate|Defined as percentage of subjects with positive beta hCG. A positive β hCG was confirmed by a blood test obtained 13-15 days after transfer.|13-15 days after transfer|The ITT analysis set was defined as all randomized subjects. Subjects were analyzed according to planned (randomized) treatment.|||percentage of participants|||Number
2576558|NCT02449889|Secondary|Number of Fertilized (2 Pronuclei (2PN)) Oocytes|Fertilization was assessed by counting the number of pronuclei, which was recorded as 0, 1, 2 or >2. Correct fertilization was defined as oocytes with 2PN.|One day after oocyte retrieval|The ITT analysis set was defined as all randomized subjects. Subjects were analyzed according to planned (randomized) treatment.|||Number of fertilized oocytes||Standard Deviation|Mean
2576559|NCT02449889|Secondary|Number of Metaphase II (MII) Oocytes|Only applicable for insemination using intracytoplasmic sperm injection (ICSI). The MII oocytes were counted prior to insemination.|Prior to insemination (within 6 hours after oocyte retrieval)|"The ITT analysis set was defined as all randomized subjects. Subjects were analyzed according to planned (randomized) treatment.~Note that only subjects with ICSI were included in this analysis, i.e. 58 subjects in the HP-hCG IM group, 55 subjects in the HP-hCG SC group and 57 subjects in the rhCG SC group."|||Number of MII oocytes||Standard Deviation|Mean
2576560|NCT02449889|Primary|Number of Oocytes Retrieved|Oocyte retrieval took place 36 h (±2h) after hCG administration. At oocyte retrieval the number of oocytes retrieved was recorded.|Approximately 36 hours after hCG administration|The ITT analysis set was defined as all randomized subjects. Subjects were analyzed according to planned (randomized) treatment.|||Number of oocytes||Standard Deviation|Mean
2576561|NCT02449798|Other Pre-specified|"Number of Attempts Prior to AccuCath 2.25 Use"|Count of catheter attempts during initial insertion before patient identified as difficult IV access|Number of IV attempts made before patient identified as difficult access and enrolled in study, could range from 3-30 minutes during initial procedure attempts||||number of attempts||Full Range|Median
2576562|NCT02449798|Secondary|Patient Satisfaction|A 5-point Likert scale (1-5) was used for measurement of satisfaction with overall IV performance at IV removal. A score of 1 indicated the lowest satisfaction, while a score of 5 indicated the highest satisfaction. A score of 3-5 was considered positive.|at IV removal, which can be up to a maximum of 29 days||||units on a scale||Full Range|Median
2576563|NCT02449798|Secondary|Patient Satisfaction|A 5-point Likert scale (1-5) was used for measurement of satisfaction with overall IV insertion experience. A score of 1 indicated the lowest satisfaction, while a score of 5 indicated the highest satisfaction. A score of 3-5 was considered positive.|At end of IV insertion, first 3-15 minutes of procedure||||units on a scale||Full Range|Median
2576564|NCT02449798|Secondary|Completion of Therapy|Count of whether the catheter lasted for the duration of intended therapy without complication requiring early removal.|During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days||||Participants|||Count of Participants
2576565|NCT02449798|Secondary|Dwell Time|IV dwell time in hours until IV is no longer needed or complicates.|Duration of IV dwell from initial insertion success through IV removal, usually ranges from 0-336 hours (0-14 days) but could be up to 696 hours (29 days)|Admitted patients|||hours||Full Range|Median
2576566|NCT02449798|Secondary|Complications|Count of IV complications that require IV removal before completion of therapy. Includes infiltration, extravasation, phlebitis, occlusion, dislodgement, infection, leaking at site, pain at site|During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days|The total number of complications resulting from all 120 IV placement procedures is reported.|||Complications|IV procedures||Number
2576567|NCT02449798|Secondary|Time to Catheter Placement|Time will be measured from initial vessel insertion through successful cannulation|At initial IV insertion attempt through successful cannulation, generally from 3-15 minutes||||minutes||Full Range|Median
2576568|NCT02449798|Primary|Number of Catheter Attempts Required to Complete Successful PIV Placement||At IV insertion attempt, generally from 3-15 minutes||||Number of Catheters||Full Range|Median
2576569|NCT02449798|Primary|First Attempt Success Rate||At initial IV insertion attempt, generally from 3-15 minutes||||Participants|||Count of Participants
2576570|NCT02449473|Secondary|Change From Baseline to Week 12, Expressed as a Ratio, in Sputum Free ECP Concentrations|ECP concentrations were determined to assess evidence of activation of eosinophils in sputum. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in sputum free ECP concentrations is presented as geometric mean ± SD of log values.|Baseline (Week 0) and Week 12|The FAS included all randomised patients who received any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Ratio||Standard Deviation|Geometric Mean
2576587|NCT02449291|Secondary|Time to Treatment Failure|Time to first violation of the criteria for complete response|0-24 hours after study drug administration||||minutes||Inter-Quartile Range|Median
2576571|NCT02449473|Secondary|Change From Baseline to Week 12, Expressed as a Ratio, in Blood Free Eosinophil Cationic Protein (ECP) Concentrations|ECP concentrations were determined to assess evidence of activation of eosinophils in blood. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in blood free ECP concentrations is presented as geometric mean ± SD of log values.|Baseline (Week 0) and Week 12|The FAS included all randomised patients who received any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Ratio||Standard Deviation|Geometric Mean
2576572|NCT02449473|Secondary|Change From Baseline to Week 12, Expressed as a Ratio, in Number of Differential Sputum Eosinophils|Sputum induction was performed to obtain satisfactory samples of sputum originating from the airways. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in the number of eosinophils in induced sputum is presented as geometric mean ± SD of log values.|Baseline (Week 0) and Week 12|The FAS included all randomised patients who received any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Ratio||Standard Deviation|Geometric Mean
2576573|NCT02449473|Secondary|Change From Baseline to Week 12, Expressed as a Ratio, in Number of Blood Eosinophils|The blood eosinophil count was obtained from the total and differential white blood cell counts. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in the number of blood eosinophils is presented as geometric mean ± SD of log values.|Baseline (Week 0) and Week 12|The FAS included all randomised patients who received any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Ratio||Standard Deviation|Geometric Mean
2576574|NCT02449473|Primary|Change From Baseline to Week 12, Expressed as a Ratio, in Number of Airway Submucosal Eosinophils|The number of airway submucosal eosinophils per millimetre squared (mm^2) was determined by microscopic evaluation of bronchoscopic biopsies. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in the number of airway submucosal eosinophils is presented as geometric mean ± standard deviation (SD) of log values.|Baseline (Week 0) and Week 12|The FAS included all randomised patients who received any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Ratio||Standard Deviation|Geometric Mean
2576575|NCT02449356|Other Pre-specified|the Incidence of Dysphonia|count the number who suffered dysphonia within the first 24 hour after extubation|within the first 24 hour after extubation|all patients in both groups were analyzed|||Participants|||Count of Participants
2576576|NCT02449356|Other Pre-specified|the Incidence of Sore Throat|count the number who suffer sore throat within the first 24 hour after extubation|within the first 24 hour after extubation|all patients in both groups were analyzed|||Participants|||Count of Participants
2576577|NCT02449356|Other Pre-specified|the Incidence of Dysphagia|count the number who suffered the dysphagia within the first 24 hours after extubation|within the first 24 hours after extubation|all patients were analyzed|||Participants|||Count of Participants
2576578|NCT02449356|Secondary|the Degree of Loose or Dampness of the Tape|counting and quantifying the number who occured the dampness or loose of the tape in both groups|at the time when patients were turning to supine position|all participants in both groups were analyzed|||Participants|||Count of Participants
2576579|NCT02449356|Secondary|The Number of the Prolapse of Endotracheal Tube|Counting the number who occured the prolapse of endotracheal tube in both groups|At any time within the procedure of the whole surgery|All participants in both groups were analyzed|||Participants|||Count of Participants
2576580|NCT02449356|Primary|Displacement of the Endotracheal Tube|We divided the degree of the displacement of the endotracheal tube into 3 kinds, which included mild(displacement distance＜0.5cm),moderate(0.5cm≤displacement distance＜1.5cm),severe (1.5cm≤displacement distance).|Participants were followed for the duration of surgery, an average of 2 hours.|All patients in each group were analyzed|||Participants|||Count of Participants
2576581|NCT02449291|Secondary|Evolution Score of Nausea (0-30 Mins)|The evolution score of nausea was calculated as the area under the curve (AUC) of the nausea scores on a scale 0-10 (where 0 is no nausea and 10 is the worst nausea imaginable) obtained at four pre-planned time points: pre-dose (0-min), and 5, 15 and 30 minutes after administration of study medication, as well as any spontaneously reported episodes of nausea during the time period, plotted against time. A higher score represents a worse outcome.|0-30 minutes after study drug administration||||Score on a scale*min||Full Range|Mean
2576582|NCT02449291|Secondary|Maximum Severity of Nausea|Highest recorded nausea score on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.|30 mins to 24 hours after study drug administration||||score on a scale||Standard Deviation|Mean
2576583|NCT02449291|Secondary|Incidence of Nausea|Proportion of patients with nausea score ≥1 on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.|30 mins to 24 hours after study drug administration||||Participants|||Count of Participants
2576584|NCT02449291|Secondary|Incidence of Significant Nausea|Proportion of patients with nausea score ≥4 on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.|30 mins to 24 hours after study drug administration||||Participants|||Count of Participants
2576585|NCT02449291|Secondary|Number of Participants Using Rescue Medication|Proportion of patients receiving pre-specified anti-emetic rescue medication at any time in the 24 hours post-treatment period|0-24 hours after study drug administration||||Participants|||Count of Participants
2576586|NCT02449291|Secondary|Number of Patients Experiencing Incidence of Emesis|Number of patients experiencing vomiting or retching during the time period from 30 minutes to 24 hours after administration of study medication|30 mins to 24 hours after study drug administration||||Participants|||Count of Participants
2576590|NCT02449291|Primary|Complete Response (Success of Initial PONV Treatment)|The primary efficacy variable was the dichotomous variable: success or failure of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes* to 24 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 24-hour period after administration of study medication.|0-24 hours after treatment||||Participants|||Count of Participants
2576591|NCT02449174|Secondary|Number of Participants Who Continue to Have Diarrhea and C. Difficile Toxin Following Fecal Microbiota Transplantation From a Healthy Donor|diarrhea was defined as more than 3 episodes of loose/watery stools in 2 consecutive days|60 days after the procedure|subjects had more than 3 episodes of C. difficile infection and were treated with FMT|||Participants|||Count of Participants
2576592|NCT02449174|Primary|Safety as Assessed by Number of Participants With Any Adverse Events (AE)s|any untoward medical occurrence associated with the use of PRIM-DJ2727 whether or not considered drug related is considered as an adverse event (AE)|6 months after the procedure||||Participants|||Count of Participants
2576593|NCT02449044|Secondary|Change From Baseline in the Hyponatremia Disease-specific Survey|Analysis of individual items of Hyponatremia Disease-specific Survey was not conducted, because the analysis of Hyponatremia Disease-specific Survey was focused on the PCS and MCS summary scores since these 2 scores were developed. Subgroup analyses of Hyponatremia Disease-specific Survey were also not conducted.|Baseline to Week 214|The Hyponatremia Disease-specific Survey PCS and MCS scores evaluated during the trial were variable with only nominal changes from baseline observed. The data were collected under 2 different datasets, so the number of participants in each dataset was reduced that limited analysis of this endpoint.||||||
2576594|NCT02449044|Secondary|Mean Change From Baseline in SF-12 (Health Survey) Mental Component Summary (MCS)|The MCS assess the physical and mental dimensions of health-related quality of life. The MCS is equal to the sum of the items of concentration activities, calculating activities, language activities, and memory activities. The MCS is a computed score with weighted function based on the 12 questions from the 8 subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health) of the SF-12v1 questionnaire per instructions by the scale's publisher. The scale ranges from 0 to 100 with 0 representing the lowest level of health and 100 indicating the highest level of health.|Baseline to Week 214|The ITT dataset comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.|||Units on a scale||Standard Deviation|Mean
2576595|NCT02449044|Secondary|Mean Change From Baseline in SF-12 (Health Survey) Physical Component Summary (PCS)|The PCS assess the physical and mental dimensions of health-related quality of life. The PCS is equal to the sum of the items of endurance activities, strength activities, gross coordination activities, and fine coordination activities. The PCS is a computed score with weighted function based on the 12 questions from the 8 subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health) of the SF-12v1 questionnaire per instructions by the scale's publisher. The scale ranges from 0 to 100 with 0 representing the lowest level of health and 100 indicating the highest level of health.|Baseline to Week 214|The ITT dataset comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.|||Units on a scale||Standard Deviation|Mean
2576596|NCT02449044|Secondary|Mean Change From Baseline in Body Weight by Visit for Those Participants Who Had Clinical Evidence of Hypervolemia at Baseline|Body weight at each visit (assessed only for those with clinical evidence of hypervolemia at Baseline) and was summarized using descriptive statistics.|Baseline to Week 214|The ITT dataset comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit were analyzed. The observed cases (OC) dataset consisted of only data points obtained from participants who were evaluated at the visit, without missing study drug consecutively for 14 days.|||kg||Standard Deviation|Mean
2576597|NCT02449044|Secondary|Percentage of Participants Requiring Prescription of Other Medicines|Percentage of participants requiring prescription of other medicines for the express purpose of treating hyponatremia during each period of the trial, assessed descriptively at each visit.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. Percentage of participants requiring other medicines such as demeclocycline or urea was not analyzed.|||percentage of participants|||Number
2576598|NCT02449044|Secondary|Number of Participants Requiring Prescription of Hypertonic Saline|Percentage of participants requiring prescription of hypertonic saline for the express purpose of treating hyponatremia during each period of the trial, assessed descriptively at each visit.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. Percentage of participants requiring prescription of hypertonic saline was not analyzed due to a low number of participants who received the treatment.|||participants|||Number
2576599|NCT02449044|Secondary|Percentage of Participants Requiring Prescription of Fluid Restriction|Percentage of participants requiring prescription of fluid restriction for the express purpose of treating hyponatremia during each period of the trial. Assessed descriptively at each visit.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.|||percentage of participants|||Number
2576621|NCT02449018|Primary|Change From Baseline in Lung Clearance Index (LCI)|Change from baseline to Day 29 in LCI as measured by multiple breath nitrogen washout (MBNW) technique. MBNW is the time taken to wash out nitrogen while breathing 100% oxygen.|Baseline and Day 29|Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.|||Days||Standard Deviation|Mean
2584037|NCT02359903|Secondary|Time of Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade||2 weeks|||||||
2576600|NCT02449044|Secondary|Change From Baseline in Percentage of Participants With Normal Sodium Levels|"Percentage of participants with varying degrees of hyponatremia (severe <130, mild 130-135, normal >135 mEq/L) at Baseline and each study visit."|Baseline to Week 214|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.|||percentage of participants|||Number
2576601|NCT02449044|Secondary|Change From Baseline in Percentage of Participants With Mild Hyponatremia|"Percentage of participants with varying degrees of hyponatremia (severe <130, mild 130-135, normal >135 mEq/L) at Baseline and each study visit."|Baseline to Week 214|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.|||percentage of participants|||Number
2576602|NCT02449044|Secondary|Change From Baseline in Percentage of Participants With Severe Hyponatremia|"Percentage of participants with varying degrees of hyponatremia (severe <130, mild 130-135, normal >135 mEq/L) at Baseline and each study visit."|Baseline to Week 214|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.|||percentage of participants|||Number
2576603|NCT02449044|Secondary|Mean Change From Baseline in Serum Sodium Measurements|Sodium measurements obtained at designated intervals were compared to each participant's Baseline sodium level at the beginning of placebo-controlled therapy in their original trial and from Baseline on initiation of therapy in the open-label trial.|Baseline of parent trial to Week 214|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed. In the last observation carried forward (LOCF) dataset, missing data were filled in using the participant's preceding non-missing value, except that Baseline value will not be carried forward.|||mEq/L||Standard Deviation|Mean
2576604|NCT02449044|Primary|Participants With Body Weight Abnormalities Reported as TEAEs|The body weight evaluation was one of the primary parameters to measure the safety and tolerability of individual participants. Every effort was made to ensure that body weight measurements were performed in a reproducible and consistent manner. The pre-defined criteria was change of ≥7% in body weight for both male and female. Participants were to wear the same type of clothes at each measurement, preferably a gown and no shoes. All body weight measurements were to have been taken post-void.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.|||participants|||Number
2576605|NCT02449044|Primary|Participants With Vital Signs Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs)|The vital signs were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria. Criteria for identifying vital signs of potential clinical relevance included: Heart rate, supine: >= 120 beats per minute (bpm) + increase of ≥15 bpm from Baseline and <=50 bpm + decrease of >= 15 bpm; Diastolic Blood Pressure, Supine: >=105 mmHg + increase of >=15 mmHg and <=50 mmHg + decrease of >=15 mmHg; Systolic Blood Pressure, Supine: >=180 mmHg + increase of >=20 mmHg and <= 90 mmHg + decrease of >=20 mmHg; Temperature (degree C): Increase of >=1.1 to >=38.3C. The vital sign abnormalities were reported as TEAEs are mentioned below.|Baseline to Post-Week 214 follow-up visit|The intent-to-treat (ITT) dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.|||participants|||Number
2576606|NCT02449044|Primary|Participants With Electrocardiogram (ECG) Related Abnormalities Reported as TEAEs|The ECG was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in HR outliers, PR outliers, QRS outliers, QT, QTcB, QTcF that were identified based on pre-defined criteria. Some of the pre-defined criteria for identifying ECG measurements of potential clinical relevance included: For QTcB and QTcF: baseline mean of QTcB and QTcF interval was new onset >500 msec, 30 - 60 msec, >60 msec; For QT: new onset >500 msec; For QRS outliers: >=25% change from baseline when QRS >100 msec; PR outliers: >=25% change from baseline when PR>200 msec; HR outliers: 25% decrease from baseline and HR <50 bpm or 25% increase from baseline and HR >100 bpm. New onset (>500 msec) in QT, QTcB, or QTcF means a participant who attained a value >500 msec during treatment period but not at each baseline visit. The ECG-related abnormalities are reported as TEAEs are mentioned below.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.|||participants|||Number
2576607|NCT02449044|Primary|Participants With Laboratory Values Abnormalities Reported as TEAEs|The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria. Any value outside the normal range was flagged for the attention of the study physician who was to indicate whether the value was clinically significant for identifying laboratory values of potential clinical relevance. Participants noted with abnormal laboratory values are reported below.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.|||participants|||Number
2576620|NCT02449018|Secondary|Change From Baseline in FEV1 Pre-bronchodilator|Change From Baseline to Day 29 in FEV1 will be measured by spirometer before bronchodilator administration. Forced Expiratory Volume in 1 Second (FEV1) is the amount of air that can be exhaled in 1 second. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.|Day 29|Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.|||Liters||Standard Deviation|Mean
2576608|NCT02449044|Primary|Participants With Adverse Events (AEs)|A TEAE was an AE that began after the first injection or was continuous from Baseline and was defined as any new medical problem, or exacerbation of an existing problem, whether or not it was considered drug-related by the study physician. An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-subject hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent the outcomes mentioned above.|Baseline to Post-Week 214 follow-up visit|The ITT dataset, which comprised of data from all enrolled participants who had observations at Baseline and at least one Post-Baseline visit, were analyzed.|||participants|||Number
2576609|NCT02449018|Secondary|Plasma Concentration of QBW251 by AUC0-12h|AUC 0-12h is the area under the plasma concentration-time curve from time zero to 12 hours.|Day 1, Day 28|PK analysis set: included all patients with at least one available valid PK concentration measurement. Due to practicalities of study conduct PK samples were collected only up to 8 hours. As a result, from noncompartmental analysis AUClast was not calculated up to 12 hours after dosing So this data is not available.||||||
2576610|NCT02449018|Secondary|Plasma Concentration of QBW251 by AUClast (0-8hours)|AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.|Day 1, Day 28|Pharmacokinetics (PK): all patients with at least one available valid PK concentration measurement, who received study drug, and no protocol deviations with relevant impact on PK data. 3 patients had no sufficient concentration data on Day 1 and 2 patients had no concentration data on Days 1 and 28. 7 patients had no concentration data on Day 28|||hr×ng/mL||Standard Deviation|Mean
2576611|NCT02449018|Secondary|Plasma Concentration of QBW251 by CMax (0-8hours)|Cmax is the observed maximum plasma concentration following drug administration.|Day 1, Day 28|Pharmacokinetics (PK): all patients with at least one available valid PK concentration measurement, who received study drug, and no protocol deviations with relevant impact on PK data. 3 patients had no sufficient concentration data on Day 1 and 2 patients had no concentration data on Days 1 and 28. 7 patients had no concentration data on Day 28|||ng/mL||Standard Deviation|Mean
2576612|NCT02449018|Secondary|Plasma Concentration of QBW251 by TMax (0-8hours)|Tmax is the time to reach the maximum concentration after drug administration.|Day 1, Day 28|Pharmacokinetics (PK): all patients with at least one available valid PK concentration measurement, who received study drug, and no protocol deviations with relevant impact on PK data. 3 patients had no sufficient concentration data on Day 1 and 2 patients had no concentration data on Days 1 and 28. 7 patients had no concentration data on Day 28|||hr||Full Range|Median
2576613|NCT02449018|Secondary|Change From Baseline in DLCO|Diffusing capacity of the lung for carbon monoxide (DLCO) is the extent to which oxygen passes from the lung to the blood.|Day 29|Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data|||ml/min/mmHg||Standard Error|Least Squares Mean
2576614|NCT02449018|Secondary|Change From Baseline in FRC|Change From Baseline to Day 29 in FRC will be measured by spirometry. Functional residual capacity (FRC) is the volume in the lungs at the end-expiratory position. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.|Day 29|Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data|||Liters||Standard Deviation|Least Squares Mean
2576615|NCT02449018|Secondary|Change From Baseline in RV|Change From Baseline to Day 29 in RV will be measured by spirometry. Residual volume (RV) is the volume of air remaining in the lungs after a maximal exhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.|Day 29|Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data|||Liters||Standard Deviation|Least Squares Mean
2576616|NCT02449018|Secondary|Change From Baseline in TLC|Change From Baseline to Day 29 in TLC will be measured by spirometry. Total lung capacity (TLC) is the volume in the lungs at maximal inflation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.|Day 29|Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.|||Liters||Standard Deviation|Least Squares Mean
2576617|NCT02449018|Secondary|Change From Baseline in FVC Post- Bronchodilator|Change From Baseline to Day 29 in FVC will be measured by spirometer after bronchodilator administration. Forced Vital Capacity (FVC) is the maximum amount of air a person can expel from the lungs after a maximum inhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. Forced vital capacity (FVC) as a measure of lung function, measured after bronchodilator|Day 29|Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.|||Liters||Standard Deviation|Least Squares Mean
2576618|NCT02449018|Secondary|Change From Baseline in FVC Pre Bronchodilator|Change From Baseline to Day 29 in FVC will be measured by spirometer before bronchodilator administration. Forced Vital Capacity (FVC) is the maximum amount of air a person can expel from the lungs after a maximum inhalation. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. Forced vital capacity (FVC) as a measure of lung function, measured before bronchodilator|Day 29|Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.|||Liters||Standard Deviation|Least Squares Mean
2576619|NCT02449018|Secondary|Change From Baseline in FEV1 Post-bronchodilator|Change From Baseline to Day 29 in FEV1 will be measured by spirometer after bronchodilator administration. Forced Expiratory Volume in 1 Second (FEV1) is the amount of air that can be exhaled in 1 second. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.|Day 29|Pharmacodynamics (PD): analysis set included all patients with available PD data and no major protocol deviations with relevant impact on PD data.|||Liters||Standard Deviation|Mean
2576622|NCT02448914|Other Pre-specified|Treatment Response Scale (ON/OFF Effect) - Mean % of Time Patients Were in Functional ON State During 3-14 h|"Dyskinesia and parkinsonism symptoms were evaluated throughout the study period as an assessment of the clinical response. To assess the ON/OFF effect the Treatment Response Scale (TRS) was used. The TRS ranges from -3 (severe OFF) to +3 (ON with severe dyskinesia). Results from the TRS recordings are presented as the mean percentage of time patients were in functional ON state (TRS: -1 to +1) during the time interval 3-14 h."|TRS assessments were made every 30 minutes from start of study drug administration until 3 h, every hour between 3 and 14 h and every 30 minutes between 14 and 17 h.||||Mean % of time||Full Range|Mean
2576623|NCT02448914|Secondary|Dose Adjusted AUC (0-14h) for 3-O-Methyldopa||During 14 h infusion on 2 consecutive days||||h*ng/mL/mg||Full Range|Least Squares Mean
2576624|NCT02448914|Secondary|Number of Adverse Events||Patients will be followed for the duration of the hospital stay, an expected average of 3 days||||adverse events|||Number
2576625|NCT02448914|Secondary|Dose Adjusted AUC (0-14h) for Carbidopa||During 14 h infusion on 2 consecutive days||||h*ng/mL/mg||Full Range|Least Squares Mean
2576626|NCT02448914|Secondary|Intra-individual Coefficient of Variation (3-14h) for Levodopa|The individual patient's coefficient of variation (CV) of levodopa plasma concentration during administration of TRIGEL and Duodopa respectively between 3 and 14 h after start of study drug. CV=100*sqrt (exp (SDlog*SDlog)-1) were SDlog denotes the standard deviation computed on logged plasma concentrations.|During 3-14h infusion on 2 consecutive days||||percentage of variability||Full Range|Least Squares Mean
2576627|NCT02448914|Primary|Dose Adjusted Area Under the Curve (AUC) (0-14h) for Levodopa||During 14 h infusion on 2 consecutive days||||h*ng/mL/mg||Full Range|Least Squares Mean
2576628|NCT02448875|Secondary|Mean Change From Screening to 12 Months Postoperative in Number of Topical IOP-lowering Medications Used|The number of IOP lowering medications in subjects at 12 months was compared to medicated baseline. A higher negative change indicates improvement. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.|Screening (Day -2), Month 12 PostOperative|Full Analysis Set with data available|||IOP-lowering medications||Standard Deviation|Mean
2576629|NCT02448875|Secondary|Percentage of Eyes Using Ocular Hypotensive Medication at 12 Months|The use of ocular hypotensive medications was assessed in subjects with at least one IOP-lowering medication at 12 Months. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.|Month 12 PostOperative|Full Analysis Set with data available|||percentage of eyes|Eyes||Number
2576630|NCT02448875|Secondary|Mean Change From Baseline to 12 Months Postoperative in Medicated IOP|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A higher negative change indicates improvement. One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.|Baseline (Day -1), Month 12 PostOperative|Full Analysis Set with data available|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2576631|NCT02448875|Secondary|Percentage of Subjects With Device-related Ocular Adverse Events|A device related adverse event (AE) was any AE that was considered to be possibly, probably, or definitely related to the device in the opinion of the investigator. Reported categorically as intraoperative (start date on the date of surgery) and postoperative (start date after surgery). One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.|Up to Month 12 PostOperative|Full Analysis Set|||percentage of subjects|||Number
2576632|NCT02448875|Primary|Percentage of Subjects With ≥ 20% Decrease From Baseline to 12 Months Postoperative in IOP Without Use of Ocular Hypotensive Medication|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. No formal statistical hypothesis testing was planned for the study.|Baseline (Day -1), Month 12 PostOperative|Full Analysis Set with data available|||percentage of subjects|||Number
2576633|NCT02448862|Secondary|Incidence of Dizziness or Headaches|The percentage of participants who had headache and dizziness|Postoperative 48 hours||||percentage of participants|||Number
2576634|NCT02448862|Secondary|Incidence of Nausea and Vomiting|The percentage of participants who had nausea and vomiting during postoperative 48 hours|Postoperative 48 hours||||percentage of participants|||Number
2576635|NCT02448862|Secondary|Postoperative Pain in Numeric Pain Scale|The Numeric Pain Scale (NRS - 0: no pain, 10: worst pain can't imagine) for pain measured once at each time periods (0~6, 6~12, 12~18, 18~24, 24~48 hours)|Postoperative 48 hours||||Scores on a scale||Standard Deviation|Mean
2576636|NCT02448862|Primary|Incidence of Rescue Antiemetics Requirement|The proportion of patients who required rescue antiemetics at least once during the postoperative 48-hour period|Postoperative 48 hours||||Percentage of Participants|||Number
2576637|NCT02448862|Primary|Incidence of Rescue Analgesics Requirement|The percentage of patients who required rescue analgesics at least once during the postoperative 48-hour period|Postoperative 48 hours||||Percentage of Participants|||Number
2576638|NCT02448810|Secondary|Change From Baseline for Quality of Life (QoL) Measure - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)|EORTC QLQ-C30 was a validated instrument used to measure QoL and assess symptoms and side effects of treatment and the impact on everyday life.The QLQ-C30 was composed of: A) 5 multi-item functioning scales(physical, role, social, emotional and cognitive), that were answered on a 4-point scale (1=Not at all,2=A Little,3=Quite a Bit,4=Very Much). Each score range from 0 to 100 with a higher score representing a higher level of functioning and a better QoL. B) A global health status/QoL scale that was answered on a 7-point scale (1=Very Poor to 7=Excellent). Each score range from 0 to 100 with a higher score representing a better QoL. C) 9 symptom scales(fatigue, nausea/vomiting,pain,financial impact/difficulties,appetite loss,diarrhea, constipation,sleep disturbance/insomnia and dyspnea), that were answered on a 4-point scale (1=Not at all,2=A Little,3=Quite a Bit,4=Very Much). Each score range from 0 to 100 with a higher score representing a greater degree of symptoms and a worse QoL.|Baseline, 21 Months (EOT) up to follow-up|SAS included all participants who received at least 1 administration of study drug.|||score on a scale||Standard Deviation|Mean
2576677|NCT02448563|Secondary|Change From Baseline Weight to 8 Weeks||Baseline and 8 weeks||||kilograms||Standard Error|Mean
2576639|NCT02448810|Secondary|Overall Survival|Overall survival was defined as the time from randomization until death due to any cause. Here, number of participants analyzed was based on the number of participants who underwent death.|From start of study drug administration up to EOT (approximately 21 Months)|FAS included all participants who received at least 1 administration of study drug, and had 1 postbaseline tumor response assessment based on RECIST v1.1, or died within 18 weeks of the start of treatment.|||weeks||95% Confidence Interval|Median
2576640|NCT02448810|Secondary|Number of Participants With Response Evaluation According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|Number of participants with response evaluation according to RECIST v1.1 was evaluated according to complete response (CR): disappearance of all target and non-target lesions and no new lesions; partial response (PR): >= 30 percent (%) decrease in the sum of diameters of target lesions (compared to baseline) and no new lesions; stable disease (SD): neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; progressive disease (PD): >= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of >=5 millimeter (mm) (compared to the previous minimum sum) or progression of a new lesion.|Day 28 of Cycle 2 followed by every 2 Cycles of 28 day Cycles: Day 56, Day 112, Day 168 and Day 224|FAS included all participants who received at least 1 administration of study drug, and had 1 postbaseline tumor response assessment based on RECIST v1.1, or died within 18 weeks of the start of treatment.|||Participants|||Count of Participants
2576641|NCT02448810|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement. TEAEs was defined as any event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments.|From start of study drug administration up to EOT (approximately 21 Months)|SAS included all participants who received at least 1 administration of study drug.|||Participants|||Count of Participants
2576642|NCT02448810|Secondary|Number of Participants With Incidence of Infusion Reactions After Imalumab Administration|Infusion reaction was defined as any relevant sign or symptom occurring during or after imalumab infusion and considered by the investigator as an infusion reaction.|From start of study drug administration up to EOT (approximately 21 Months)|SAS included all participants who received at least 1 administration of study drug.|||Participants|||Count of Participants
2576643|NCT02448810|Secondary|Number of Participants With Occurrence of Binding and/or Neutralizing Anti-imalumab Antibodies|Number of participants with occurrence of binding and/or neutralizing anti-imalumab antibodies were reported.|From start of study drug administration up to end of treatment (EOT) (approximately 21 Months)|SAS included all participants who received at least 1 administration of study drug.|||Participants|||Count of Participants
2576644|NCT02448810|Primary|Part 1: Number of Participants With Occurrence of Dose Limiting Toxicity (DLT)|DLT was defined as any drug-related treatment-emergent adverse event (TEAE) (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v4.03) that occurs during the first 28 days after treatment start and that meets any of the following criteria: i) Any >= Grade 3 non-hematologic toxicity (excluding: mucositis/stomatitis of Grade 3; diarrhea of <3 days duration; nausea and vomiting <3 days duration; fatigue of <7 days duration; alopecia; single laboratory value out of the normal range that has no clinical significance and that resolves to <= Grade 2 with adequate measures within 7 days) ii) Any Grade 4 hematologic toxicity (excluding: grade 4 neutropenia lasting for <= 5 days; isolated grade 4 lymphocytopenia) iii) Grade 3 febrile neutropenia iv) Grade 3 thrombocytopenia associated with bleeding v) Any life-threatening complication or abnormality not covered in NCI CTCAEv4.03.|From start of study treatment up to 28 days|SAS included all participants who received at least 1 administration of study drug.|||Participants|||Count of Participants
2576645|NCT02448810|Primary|Part 2: Progression-Free Survival (PFS)|PFS was defined as time between treatment initiation and tumor progression (per Response Evaluation Criteria in Solid Tumors [RECIST] v1.1 criteria) or death from any cause, with censoring of participants who were lost to follow-up or withdrew consent.|From start of the study up to safety follow-up visit occurred (30 [-/+7]) days after the last dose of study treatment or until disease progression|Full analysis set (FAS) included all participants who received at least 1 administration of study drug, and who had 1 postbaseline tumor response assessment based on RECIST v1.1, or died within 18 weeks of the start of treatment.|||weeks||95% Confidence Interval|Median
2576646|NCT02448719|Secondary|Tmax: Time to Reach the Cmax for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2||Day -1: pre-dose and Day 1 at multiple time points (0.5, 1, 1.5, 2, 2.5, 4, 5, 6, 10, 11, 12, 24 hours; up to 24 hours) post-dose|Safety analysis set included all participants who received at least 1 dose of study drug.|||hour||Full Range|Median
2576647|NCT02448719|Secondary|Cmax: Maximum Observed Plasma Concentration for Total BCAA Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2||Day -1: pre-dose and Day 1 at multiple time points (0.5, 1, 1.5, 2, 2.5, 4, 5, 6, 10, 11, 12, 24 hours; up to 24 hours) post-dose|Safety analysis set included all participants who received at least 1 dose of study drug.|||micromole per liter (mcmol/L)||Standard Deviation|Mean
2576648|NCT02448719|Secondary|AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2||Day -1: pre-dose and Day 1 (2.5 hours post dose)|Safety analysis set included all participants who received at least 1 dose of study drug.|||micromole*hour per liter (mcmol*hr/L)||Standard Deviation|Mean
2576649|NCT02448719|Secondary|Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose||Day 1: pre-dose and at multiple timepoints (6, 12, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose|PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.|||percentage (%) of dose||Standard Deviation|Mean
2576678|NCT02448563|Primary|Feasibility as Measured by Attendance at Group Sessions and Barriers to Attendance (Logs Kept by Research Staff)||Weekly up to 8 weeks||||participants|||Number
2576650|NCT02448719|Secondary|Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II||Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose|PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.|||hours||Full Range|Median
2576651|NCT02448719|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II||Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose|PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2576652|NCT02448719|Secondary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II||Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose|PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2576653|NCT02448719|Secondary|AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II||Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose|PK analysis set included all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2576654|NCT02448719|Primary|Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS)|The gastrointestinal (GI) symptoms (abdominal pain, heartburn, acid regurgitation, hunger pains, nausea, borborygmus, abdominal distension, eructation, increased flatus, constipation, diarrhoea, loose stools, hard stools, urgent need for defecation, and feeling of incomplete evacuation) using GSRS questionnaires at each assessment point. The GSRS a 15-item self-administered questionnaire that assesses the impact of GI symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to GI symptoms. TEAEs related to GSRS were reported as follows: Diarrhoea, Constipation, Faeces hard, and Faeces soft.|Baseline up to Day 5|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2576655|NCT02448719|Primary|Number of Participants With TEAEs Related to Laboratory Tests|Reported TEAE Related to Laboratory Tests are following; Occult blood positive, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Blood creatine phosphokinase increased, Blood glucose increased, Blood triglycerides increased, Blood urine present, Protein urine present, and White blood cell count increased.|Baseline up to Day 5|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2576656|NCT02448719|Primary|Number of Participants With TEAE Related to Electrocardiograms (ECG)||Baseline up to Day 5|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2576657|NCT02448719|Primary|Number of Participants With TEAE Related to Body Weight||Baseline up to Day 5|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2576658|NCT02448719|Primary|Number of Participants With TEAE Related to Vital Signs|Vital signs included body temperature (infra-axillary measurement), supine blood pressure (systolic and diastolic) after the participant has rested for at least 5 minutes, respiratory rate, and pulse (beats per minute [bpm]).|Baseline up to Day 5|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2576659|NCT02448719|Primary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)||Baseline up to Day 8|Safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2576660|NCT02448706|Secondary|Adherence|Average number of hours per day the hearing aid was worn.|6 weeks||||hours per day||Standard Deviation|Mean
2576661|NCT02448706|Secondary|Speech and Spatial Qualities of Hearing (SSQ) Questionnaire|Listener rates her/his perceived ability. Each question describes a different situation, such as listening to one talker in quiet. Test is scored from 0 to 10, with 10 = best score.|6 weeks||||score on a scale||Standard Deviation|Mean
2576662|NCT02448706|Secondary|Effectiveness of Aural Rehabilitation (EAR)|The listener rates the extent to which hearing has improved with the hearing aid (0=least improved, 100=most improved).|6 weeks||||score on a scale||Standard Deviation|Mean
2576663|NCT02448706|Primary|Speech Intelligibility Score|Participants listen to sentences in a background of noise and repeat the sentence heard. The outcome is percentage of correctly repeated words.|6 weeks||||percentage of correct responses||Standard Deviation|Mean
2576664|NCT02448641|Secondary|Global Rating of Perceived Change Response Rate|"Global Rating of Perceived Change from Baseline: Subjects and Clinicians were asked about perceived changes in their motor function by comparing how well they are doing compared to before the surgical procedure. The Subject Global Rating of Perceived Change was completed by the subject (or by the caregiver using the subject's answers). The following 7-point Likert scale was used: Score 7 (much better); Score 6 (a little better, meaningful); Score 5 (a little better, not meaningful); Score 4 (about the same); Score 3 (a little worse, not meaningful); Score 2 (a little worse, meaningful); Score 1 (much worse)"|6 Months||||Participants|||Count of Participants
2576679|NCT02448537|Secondary|Treatment Related Serious Adverse Events|Summary of the serious adverse events (SAE) experienced by participants that were deemed to be at least possibly related to PM01183 when administered alone or with Doxorubicin or Gemcitabine. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE v4).|From the start of treatment until 30 days after the end of treatment||||participants|||Number
2576665|NCT02448641|Secondary|Neurological Quality of Life Response|The Neurological Quality of Life (NeuroQOL) was used as a measure of change in the levels of Quality of Life, Satisfaction and Participation, secondary to improvements in the subject's upper and lower extremity motor function. NeuroQOL is summation of item scores for upper extremity (8 terms: score 8 - 40) and lower extremity (8 items: score 8 - 40) separately. The item scores are on a 1 to 5 scale (1 = unable to do; 2 = with much difficulty; 3 = with some difficulty; 4 = with little difficulty; 5 = without any difficulty). The result provided here shows NeuroQOL score converted to T-score as per conversion tables provided in Statistical Analysis Plan (SAP)-document Page no. 41 and 42. Referring to that, the range for Upper extremity T-score and Lower extremity T-score are 12.8 to 53.8 and 16.5 to 58.6 respectively. For any other information associated with NeuroQOL calculation, please refer SAP document dated December 21, 2018 provided under document section of this study.|baseline, Month 6||||units on a scale||Standard Deviation|Mean
2576666|NCT02448641|Secondary|Gait Velocity Response Rate; Modified Intent to Treat Population|Gait Velocity was measured on a standard 10 meter walk. Two trials were tested and the average result from the two trails was used for analysis|Month 6||||Participants|||Count of Participants
2576667|NCT02448641|Secondary|Action Research Arm Test Response, Modified Intent to Treat Population|Action Research Arm Test (ARAT): The test was scored for left and right side separately. Performance on each item was rated on a 4-point ordinal scale ranging from: 3 (performed test normally in less than 5 seconds); 2 (completed test, but took abnormally long or had great difficult, with time varying from 5 to 60 seconds; 1 (performed test partially); 0 (could perform no part of the test). The ARAT is a 19-item measure divided into 4 subtests: Grasp subscale (with 6 items and a score range of 0 to 18); Grip subscale with 4 items and a score range of 0 to 12); Pinch subscale with 6 items and a score range of 0 to 18); Gross arm movement subscale (with 3 items and a score range of 0 to 9). The maximum score on the ARAT is 57 points (possible range 0 to 57) for each side.|Month 6||||Participants|||Count of Participants
2576668|NCT02448641|Secondary|Modified Rankin Scale Response, Modified Intent to Treat Population|Modified Rankin Scale (mRS): This scale is used to measure the degree of disability or dependence in the daily activities of people who had suffered a stroke. The mRS is an ordinal scale from 0 (no symptoms at all) to 5 (severe disability; requiring constant nursing care and attention, bedridden, incontinent) with a sixth category of death.|Month 6||||Participants|||Count of Participants
2576669|NCT02448641|Primary|Additional Analysis, Fugl-Meyer Motor Scale (FMMS)|FMMS motor total score is summation of all 50 item scores with maximum of 100 points. The item scores are on 0 to 2 scale (0 = cannot perform, 1 = partial motion, 2 = full motion)|Month 6||||score on a scale||Standard Deviation|Mean
2576670|NCT02448641|Primary|Fugl-Meyer Motor Scale Total Score Response; Per Protocol Population|Fugl-Meyer Motor Scale (FMMS) Motor Total Score: The FMMS is used as a clinical measure of body function impairment after stroke that assessed several dimensions of motor impairment, including range of motion in both upper and lower limbs, including reflex activity, volitional movement, and co-ordination. The upper extremity subscale (33 items) and lower extremity subscale (17 items) were assessed for determination of efficacy. The FMMS is an ordinal scale that has 3 points for each item. The upper limb is scored between 0 and 66 points and the lower limb is scored between 0 and 34 points. The FMMS motor total score range from 0 (hemiplegia) to a maximum of 100 points (normal motor performance).|Month 6||||Participants|||Count of Participants
2576671|NCT02448641|Primary|Fugl-Meyer Motor Scale Total Score Response; Modified Intent to Treat Population|Fugl-Meyer Motor Scale (FMMS) Motor Total Score: The FMMS is used as a clinical measure of body function impairment after stroke that assessed several dimensions of motor impairment, including range of motion in both upper and lower limbs, including reflex activity, volitional movement, and co-ordination. The upper extremity subscale (33 items) and lower extremity subscale (17 items) were assessed for determination of efficacy. The FMMS is an ordinal scale that has 3 points for each item. The upper limb is scored between 0 and 66 points and the lower limb is scored between 0 and 34 points. The FMMS motor total score range from 0 (hemiplegia) to a maximum of 100 points (normal motor performance).|6 months||||Participants|||Count of Participants
2576672|NCT02448563|Secondary|Waist Circumference at 8 Weeks||8 weeks||||centimeters||Standard Deviation|Mean
2576673|NCT02448563|Secondary|Changes in Baseline Physical Activity to 8 Weeks as Measured by the Kaiser Physical Activity Scale|Activity indices were created for each domain of activity (household/caregiving, occupational, active living, sports/exercise) by summing the domain-specific categorical responses and dividing by the number of items, giving an average value that ranged from 1 to 5. We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree). What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at Baseline from that measured at 8 weeks (difference = 8 weeks score - baseline score).|Baseline and 8 weeks||||units on a scale||Standard Error|Mean
2576674|NCT02448563|Secondary|Changes in Baseline Body Image to 8 Weeks as Measured by the 34-item Multidimensional Body Relations Questionnaire|The Multidimensional Body Relations Questionnaire (MBSRQ-AS) includes the following subscales: Appearance Evaluation, Appearance Orientation, Overweight Preoccupation, Self-Classified Weight, and the Body Areas Satisfaction Scale (BASS). We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree). What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at baseline from that measured at 8 weeks (difference = 8 weeks score - Baseline score). Scale ranges from 1-5 (1=definitely disagree, 2=mostly disagree, 3=neither agree nor disagree, 4=mostly agree, 5=definitely agree) with higher scores reflecting better outcome. A positive value shows improvement in that subscale over time.|Baseline and 8 weeks||||units on a scale||Standard Error|Mean
2576675|NCT02448563|Secondary|Changes in Baseline Eating Behaviors to 8 Weeks as Measured by Eating Behavior Patterns Questionnaire|Items were rated on a 5 point scale (1 strongly disagree, 2 disagree, 3 neutral or not applicable, 4 agree, 5 strongly agree). We summed the scores of the component items that comprised each scale (and higher scores are those where respondents are more likely to strongly agree). What is reported in the tables are the differences in raw scores computed by subtracting the summed scores at baseline from that measured at 8 weeks (difference = 8 weeks score - Baseline score).|Baseline and 8 weeks||||z-score||Standard Error|Mean
2576676|NCT02448563|Secondary|Participant Satisfaction as Measured by Questionnaire and Exit Interview||8 weeks||||Percentage|||Number
2576681|NCT02448537|Secondary|Overall Response Rate|"The overall response rate is the number of participants that achieved either Stable Disease (SD), a Partial Response (PR), or a Complete Response (CR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1). The overall response rate is the best response recorded from the start of treatment until disease progression/recurrence.~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|Every 6 weeks for the first 8 cycles (cycle is 21 days) and then every 9 weeks thereafter until disease progression||||Participants|||Count of Participants
2576682|NCT02448537|Primary|Disease Control Rate|"The number of participants that achieved either Stable Disease (SD) or a Partial Response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) at 24 weeks.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|24 Weeks|Two participants (one from the PM01183 and Doxorubicin arm and one from the PM01183 alone arm) were not able to be evaluated for response.|||Participants|||Count of Participants
2576683|NCT02448368|Secondary|Incidence of Treatment-Emergent Adverse Events||8 weeks|The safety population included all participants who received any dose of investigational product.|||Number of participants|||Number
2576684|NCT02448368|Secondary|Pharmacodynamics (PD) Profile of RDEA3170|Serum samples were collected at the following timepoints in relation to RDEA3170 dosing: Day 1 (Cohort 1 and Cohort 3): -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours prior to dosing. Days 1, 5, and 9 (Cohort 1 and Cohort 3), and Days 13 and 17 (Cohort 1 only): predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose. Urine samples (total catch) were collected at the following timepoints in relation to RDEA3170 dosing: Day 1 (Cohort 1 and Cohort 3): -24 to -21, -21 to -18, -18 to -12, and -12 to 0 hours predose. Days 1, 5, and 9 (Cohort 1 and Cohort 3), and Days 13 and 17 (Cohort 1 only): 0 to 3, 3 to 6, 6 to 12, and 12 to 24 hours postdose.|Day -1, 1, 5, 9, 13, 17|A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 (but not from pharmacodynamics analysis) following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.|||Percent (%) Change||Standard Error|Mean
2576685|NCT02448368|Primary|AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules|AUC 0-∞ is a meausre of total concentration from time zero to infinity|Day 1, 5, 9, 13, 17|A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.|||ng·hr/mL||95% Confidence Interval|Geometric Mean
2576686|NCT02448368|Primary|AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules|AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint|Day 1, 5, 9, 13, 17|A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.|||ng·hr/mL||95% Confidence Interval|Geometric Mean
2576687|NCT02448368|Primary|Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules|Cmax is the maximum observed concentration of a drug after administration|Day 1, 5, 9, 13, 17|A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.|||ng/mL||95% Confidence Interval|Geometric Mean
2576688|NCT02448368|Primary|Apparent Terminal Half-life (t1/2)|t1/2 is a measure of apparent terminal half-life|Day 1, 5, 9, 13, 17|A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.|||hr||95% Confidence Interval|Geometric Mean
2576689|NCT02448368|Primary|Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)|AUC 0-∞ is a meausre of total concentration from time zero to infinity|Day 1, 5, 9, 13, 17|A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.|||ng·hr/mL||95% Confidence Interval|Geometric Mean
2576690|NCT02448368|Primary|Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)|AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint|Day 1, 5, 9, 13, 17|A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.|||ng·hr/mL||95% Confidence Interval|Geometric Mean
2576691|NCT02448368|Primary|Time of Occurrence of Maximum Observed Concentration (Tmax)|Tmax is the time of occurrence of cmax|Day 1, 5, 9, 13, 17|A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.|||hr||Full Range|Median
2576692|NCT02448368|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax is the maximum observed concentration of a drug after administration|Day 1, 5, 9, 13, 17|A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.|||ng/mL||95% Confidence Interval|Geometric Mean
2576706|NCT02447952|Other Pre-specified|Number of Participants With Ease of Setting up and Attaching the Sensor|"The participants were required to give feedback on how easy was it to set up and/ or attach the sensor and it was categorized as easy, neutral and difficult. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)."|Up to Week 48|Full Analysis Set|||Participants|||Number
2576693|NCT02448303|Primary|Number of Participants With Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Every 12 weeks for up to 2 years|"The study participants had to have a minimum of one scan (for tumor assessment) after randomization/treatment in order to be considered analyzed.~And some of the participants didn’t make it to Wk 7 of treatment, hence reduction in the number of subjects analyzed."|||Participants|||Count of Participants
2576694|NCT02448043|Secondary|Change in Hirsutism on Hands|Photographs taken (knuckle to fingertips over white paper with consistent bulb illumination at the site), with an Apple iPhone 6 (Cupertino, CA, USA) and examined. The investigators reviewed the anonymous photos by number to look for comparative (increased hair growth, decreased hair growth, no change) hair changes on the hands.|Baseline, 30 days|- No data on 4 participants due to poor photo quality|||Hands|Hands||Count of Units
2576695|NCT02448043|Secondary|Change in Skin Pigmentation on Hands|Photographs taken (knuckle to fingertips over white paper with consistent bulb illumination at the site), with an Apple iPhone 6 (Cupertino, CA, USA) and examined. The investigators reviewed the anonymous photos by number to look for comparative skin pigmentation (increased pigmentation, decreased pigmentation, no change in pigmentation) changes on the hands.|Baseline, 30 days|"Data omitted for 4 subjects with pigmented control and medication hands~No data for an additional 4 subjects due to poor photo quality"|||Hands|Hands||Count of Units
2576696|NCT02448043|Secondary|Number of Days Until the First Nail Chipped|Average number of days post-treatment until the first nail chipped|Baseline to 30 days|- No nail chipping data on 12 participants|||Days|Hands|Standard Deviation|Mean
2576697|NCT02448043|Primary|Nail Brittleness at 30 Days of Treatment|"Scale Title: Nail Brittleness (1-4)~Subjective assessment by subjects on scale of 1 (no brittleness) to 4 (maximum brittleness)."|Baseline, 30 days|"No or incomplete data on seven subjects~Subjects were asked to assess nail brittleness of both hands and rank them together – i.e. the value each subject gave for nail brittleness was the combination of the placebo hand and the treatment hand. Nail brittleness values were not distinguished between the placebo hands and the treatment hands."|||Score on a scale||Standard Deviation|Mean
2576698|NCT02448043|Primary|Intraocular Pressure at 30 Days of Treatment|IOP using a Goldmann applanation tonometer (GAT) between 7:30 AM and 10:00 AM|Between 7:30 AM and 10:00 AM at 30 days post treatment|"No IOP data on 13 subjects Missing final IOP data on 1 subject~Arms are not grouped as ‘Bimatoprost 0.01%’ and ‘Placebo’ because this is a split-person study, so every participant received both the treatment and the placebo. Since this outcome is measuring eye pressure, there is no way to distinguish which group/arm is influencing eye pressure."|||mm Hg|Eyes|Standard Deviation|Mean
2576699|NCT02448043|Primary|Change From Baseline in Nail Length of Digits|Measured by digital calipers (Ironton 6 in. Stainless Steel Digital Fractional Caliper, Northern Tool and Equipment, Burnsville, MN, USA)|Baseline, 30 Days|Excluding the negative growth nails and chipped nails combined; one subject is missing a forefinger|||mm|Digits|Standard Deviation|Mean
2576700|NCT02448043|Primary|Change From Baseline in Nail Length of Hands|Measured by digital calipers (Ironton 6 in. Stainless Steel Digital Fractional Caliper, Northern Tool and Equipment, Burnsville, MN, USA)|Baseline, 30 days|Intent to treat population|||mm|Hands|Standard Deviation|Mean
2576701|NCT02447952|Other Pre-specified|Type of Adverse Events Secondary to the Devices Used or Due to Study Procedures|Only those AEs and SAEs which, in the opinion of the investigator, were related to a protocol-mandated procedure or one of the devices used in the study were reported. An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. Number of AEs, SAEs and Adverse events leading to discontinuation (AELDs)from the study is presented|Up to Week 48|Safety Population|||Events|||Number
2576702|NCT02447952|Other Pre-specified|Number of Participants With Adverse Events Secondary to the Devices Used or Due to Study Procedures|Only those AEs and SAEs which, in the opinion of the investigator, were related to a protocol-mandated procedure or one of the devices used in the study were reported. An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE.|Up to Week 48|Safety Population comprised of all participants who carried out at least one protocol specified procedure|||Participants|||Number
2576703|NCT02447952|Other Pre-specified|Number of Participants Whose Sensor Fell Off|The participants reported whether the sensor fell off. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Participants|||Number
2576704|NCT02447952|Other Pre-specified|Number of Participants With Corresponding Average Activity Level During Time of Wearing the Sensor|Average activity level during the time of wearing the sensor was reported by the participants, and was categorized as very low level activity, low level activity, moderate level activity and high level activity. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Participants|||Number
2576705|NCT02447952|Other Pre-specified|Number of Participants With Corresponding Activity Level Required to Complete Their Job|The activity level required by the participant to complete their job was recorded, and was categorized as Not working, Physical activity required, and Sedentary. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Participants|||Number
2576707|NCT02447952|Other Pre-specified|Number of Participants Reporting Impact on Sleep|"Participant feedback on how much the sensor impacted their sleep was categorized as not at all, moderately and minimally. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)."|Up to Week 48|Full Analysis Set|||Participants|||Number
2576708|NCT02447952|Other Pre-specified|Number of Participants Reporting Sensor Comfort|"Participant's feedback on whether the sensor was comfortable to wear was categorized as yes and no. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)."|Up to Week 48|Full Analysis Set|||Participants|||Number
2576709|NCT02447952|Other Pre-specified|Relationship Between Absolute Values of Speech Endpoints and Absolute Values of FVC|Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Between Subject Correlation Coefficient has been presented in the table below|Up to Week 48|Full Analysis Set|||Ratio|||Number
2576710|NCT02447952|Other Pre-specified|Relationship Between Absolute Values of Speech Endpoints and Absolute Value of ALSFRS-R|Mixed Model was used to calculate Repeated Measures Correlation Coefficients between the two variables when model is converged. The correlation coefficient among the repeated measurements is same for different variables. Multiple Linear Regression was used to calculate Within and Between Participant Correlation Coefficients when Mixed Model is not converged. Data for Repeated Measures Correlation Coefficient has been presented in the table below|Up to Week 48|Full Analysis Set|||Ratio|||Number
2576711|NCT02447952|Other Pre-specified|Percentage Pause Time|Percentage pause time for running speech was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Percentage of time||Standard Deviation|Mean
2576712|NCT02447952|Other Pre-specified|Maximum Phonation Time|"Maximum phonation time for the single word doily test was analyzed for quality of speech testing. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)."|Seconds|Full Analysis Set|||Seconds||Standard Deviation|Mean
2576713|NCT02447952|Other Pre-specified|Average Phoneme Rate|"Phoneme rate was analyzed for the single word doily. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)."|Up to Week 48|Full Analysis Set|||Hertz per second||Standard Deviation|Mean
2576714|NCT02447952|Other Pre-specified|Speaking Rate|Speaking rate was analyzed during running speech. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Words per minute||Standard Deviation|Mean
2576715|NCT02447952|Other Pre-specified|Duration of Maximum Gap Between Words|Duration of maximum gap between words during running speech to planned to analyze quality of speech however; was not performed.|Up to Week 48|Full Analysis Set||||||
2576716|NCT02447952|Other Pre-specified|Measurement of Speech Quality|Speech quality was assessed by Central Tendency of Fundamental Frequency (CTF) F0, jitter, and shimmer for 'short ah' and 'long ah' tests. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Hertz||Standard Deviation|Mean
2576717|NCT02447952|Other Pre-specified|Relationship Between Absolute Values of HRV Endpoints (LF/HF) and Absolute Value of Total ALSFRS-R|Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that sample size was insufficient to calculate correlation coefficient|Up to Week 48|Full Analysis Set|||Ratio|||Number
2576718|NCT02447952|Other Pre-specified|HRV Variance Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD) Analysis|HRV variance over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Milliseconds^2||Standard Deviation|Mean
2576719|NCT02447952|Other Pre-specified|Mean HRV Over 24 Hours - Mean Root Mean Square of the Successive Differences (RMSSD)|Mean HRV over 24 hours (RMSSD analysis), averaged for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Milliseconds^2||Standard Deviation|Mean
2576720|NCT02447952|Other Pre-specified|Effect of Activity on HRV Variance (LF/HF Analysis)|The effect of activity on HRV variance was calculated as [HRV variance while sedentary not lying minus HRV variance while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1.|Up to Week 48|Full Analysis Set|||Ratio||Standard Deviation|Mean
2576721|NCT02447952|Other Pre-specified|Effect of Activity on Mean HRV (LF/HF)|The effect of activity on mean HRV was calculated as [mean HRV while sedentary not lying minus mean HRV while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1.|Up to Week 48|Full Analysis Set|||Ratio||Standard Deviation|Mean
2576722|NCT02447952|Other Pre-specified|Effect of Being Upright on HRV Variance (LF/HF Analysis)|The effect of being upright on HRV variance was calculated as [HRV variance while sedentary not lying minus HRV variance while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Ratio||Standard Deviation|Mean
2576723|NCT02447952|Other Pre-specified|Effect of Being Upright on HRV- Mean HRV (LF/HF Analysis)|The effect of being upright on mean HRV was calculated as [mean HRV while sedentary not lying minus mean HRV while lying] (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Ratio||Standard Deviation|Mean
2576724|NCT02447952|Other Pre-specified|Variance of HRV While Active (LF/HF)|Variance of Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1|Up to Week 48|Full Analysis Set|||Ratio||Standard Deviation|Mean
2576725|NCT02447952|Other Pre-specified|Mean HRV While Active (LF/HF)|Mean Heart Rate Variability (HRV) averaged over 5 windows of subjects being active at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data is not available. Standard deviation could not be calculated when number of participants was <=1|Up to Week 48|Full Analysis Set|||Ratio||Standard Deviation|Mean
2576726|NCT02447952|Other Pre-specified|Variance of HRV While Sedentary Not Lying (LF/HF)|Variance of Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Ratio||Standard Deviation|Mean
2576727|NCT02447952|Other Pre-specified|Mean HRV While Sedentary Not Lying (LF/HF)|Mean Heart Rate Variability (HRV) averaged over 5 windows of sedentary not lying at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Ratio||Standard Deviation|Mean
2576728|NCT02447952|Other Pre-specified|Variance of HRV While Lying (LF/HF)|Variance of Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point (LF/HF analysis). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Ratio||Standard Deviation|Mean
2576729|NCT02447952|Other Pre-specified|Mean Heart Rate Variability (HRV) While Lying (Low Frequency[LF]/High Frequency[HF])|Mean Heart Rate Variability (HRV) averaged over 5 windows of lying down at each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Ratio||Standard Deviation|Mean
2576730|NCT02447952|Other Pre-specified|Relationship Between Average Night Time Rest Fragmentation Index Versus Total ALSFRS-R|Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented|Up to Week 48|Full Analysis Set|||Ratio|||Number
2576731|NCT02447952|Other Pre-specified|Relationship Between Average Percent Time Night Time Rest Efficiency Versus Total ALSFRS-R|Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented|Up to Week 48|Full Analysis Set|||Ratio|||Number
2576732|NCT02447952|Other Pre-specified|Relationship Between Average Duration Movement Episodes at Night Versus Total ALSFRS-R|Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented|Up to Week 48|Full Analysis Set|||Ratio|||Number
2576733|NCT02447952|Other Pre-specified|Relationship Between Average Number Night Time Movements/Hour Versus Total ALSFRS-R|Estimates for between and within subject correlation coefficients were produced following multiple linear regression analyses on the actigraphy endpoints, comparing them with the ALSFRS-R total score and the gross motor domain and fine motor domain scores. Data for between subject correlation coefficient has been presented|Up to Week 48|Full Analysis Set|||Ratio|||Number
2576734|NCT02447952|Other Pre-specified|Average Duration of Night Time Movement Episodes|Average duration of movement episodes for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Seconds||Standard Deviation|Mean
2576735|NCT02447952|Other Pre-specified|Rest Fragmentation Index|Rest Fragmentation Index was computed as movement time (%) divided by number of movement episodes for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Ratio||Standard Deviation|Mean
2576736|NCT02447952|Other Pre-specified|Percent Time Night-time Rest Efficiency|Average night-time rest efficiency for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)|Up to Week 48|Full Analysis Set|||Percentage of time||Standard Deviation|Mean
2576737|NCT02447952|Other Pre-specified|Number of Night Time Movement Episodes Per Hour|Average number of night movement episodes per hour for each protocol time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Number of movements/hour||Standard Deviation|Mean
2576738|NCT02447952|Other Pre-specified|Percent of Time Lying Down at Night|Percent time spent lying per day and night over the 24-hour recording periods; averaged for each timepoint|Up to Week 48|Full Analysis Set|||Percentage of time||Standard Deviation|Mean
2576739|NCT02447952|Other Pre-specified|Number of Continuous Active Periods|Active periods were catagorized as >1minute to <=2minutes, >2 minutes to <=5minutes, >5 minutes to <=15 minutes, >15 minutes to <=30 minutes, >30 minutes. Total number of 'active periods were calculated as 1minute<x<2minutes + 'number of active periods 2minutes<x<5minutes + 'number of active periods 5minutes<x<15minutes + 'number of active periods 15minutes<x<30minutes + 'number of active periods >30minutes.|Up to Week 48|Full Analysis Set|||Number/Hour||Standard Deviation|Mean
2576740|NCT02447952|Other Pre-specified|Mean Maximum Activity Count in a 24 Hour Period|Mean maximum activity count of day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)|Up to Week 48|Full Analysis Set|||Count of activity||Standard Deviation|Mean
2576741|NCT02447952|Other Pre-specified|Maximum Activity Count in a 24 Hour Period|Maximum activity count for the day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)|Up to Week 48|Full Analysis Set|||Count of activity||Standard Deviation|Mean
2576742|NCT02447952|Other Pre-specified|Total Activity Count|Total activity count for the day time and night time for the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Count of activity||Standard Deviation|Mean
2576743|NCT02447952|Other Pre-specified|Time Spent With Sensor Off|Sensor off time includes the time that the sensor was either switched off or the participant was not wearing it (or both). This outcome measure was planned but not performed.|Up to Week 48|Full Analysis Set||||||
2576744|NCT02447952|Other Pre-specified|Average Time Spent Sedentary.|Number of minutes spent sedentary [time spent lying + time spent sedentary not lying] per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Minutes||Standard Deviation|Mean
2576745|NCT02447952|Other Pre-specified|Average Time Spent Lying|Number of minutes spent lying per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Minutes||Standard Deviation|Mean
2576746|NCT02447952|Other Pre-specified|Average Time Spent 'Sedentary Not Lying'|Number of minutes spent 'sedentary not lying' per day and night for 24-hour recording period; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 48|Full Analysis Set|||Minutes||Standard Deviation|Mean
2576747|NCT02447952|Other Pre-specified|Average Time Spent Active|Number of minutes spent active per day and night over the 24-hour recording periods; averaged for each time point. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)|Up to Week 48|Full Analysis Set|||Minutes||Standard Deviation|Mean
2576748|NCT02447952|Other Pre-specified|Duration of Night Time Wear Time of the Device|"Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of night time wear time was the calculated as the total of the times spent [Active + day time lying + day time sedentary not lying] for the night time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data could not be calculated as participant number was <=1."|Up to Week 48|Full Analysis Set|||Minutes||Standard Deviation|Mean
2576749|NCT02447952|Primary|Duration of Day Time Wear Time of the Device|Each participant was provided one accelerometer and electrode (Faros sensor and LifeInsight Hub) through which movement/physical activity data was collected throughout the study. Duration of day time wear time was calculated by adding the durations of the time spent [Active + lying + sedentary not lying] in the day time. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).NA indicates that data could not be calculated as participant number was <=1.|Up to Week 48|Full Analysis Set included all participants with at least one post Baseline measure for the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) and at least one physical activity/movement measure.|||Minutes||Standard Deviation|Mean
2576750|NCT02447926|Primary|Suppressive Function of Expanded Cells Will be Assessed Using in Vitro Assays of Alloreactivity (Mixed Lymphocyte Culture)|Assay testing - Suppressive function of expanded cells will be assessed using in vitro assays of alloreactivity (mixed lymphocyte culture). The in vitro assays will test whether the expanded Tregs will retain their suppressive function.|21 days||||percentage of Treg inhibition|||Number
2576751|NCT02447926|Primary|Number of Regulatory CD4+CD25+ T Cells Obtained From 150 ml of Peripheral Blood in an ESLD Patient|Number of regulatory CD4+CD25+ T cells after 21 days in culture from leukapheresis product (150 ml of processed blood) from ESLD patient.|21 days||||Tregs/150ml|||Number
2576752|NCT02447887|Secondary|Overall Response Rate||Week 16|Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.||||||
2576753|NCT02447887|Secondary|Overall Response Rate||Week 8|Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.||||||
2576754|NCT02447887|Primary|Progression Free Survuval Per RECIST 1.1||At week 16|Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.||||||
2576755|NCT02447887|Primary|Progression Free Survival Per RECIST 1.1||At week 8|Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.||||||
2576756|NCT02447887|Primary|Any Unacceptable Toxicity (UT) Defined as Any CTCAE v4 Grade 5 Toxicity, Grade 4 Neuropsychiatric Toxicity or Grade 4 Clinically Significant Non-hematologic Toxicity Thought to be Definitely, Probably or Possibly Related to Study Drug.||28 Days|Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.||||||
2576757|NCT02447887|Primary|Any Toxicity Felt at the Investigator's Discretion to be Possibly or Probably Related to Ixazomib That Causes the Patient to Miss More Than 1 Dose of Either Ixazomib or pIFN in the First 28 Days.||28 Days|Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.||||||
2576758|NCT02447887|Primary|Grade 4 Neutropenia Per CTCAE v4; Lasting Longer Than 5 Days||Up to week 8|Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.||||||
2576761|NCT02447887|Primary|Non-hematologic Toxicity ≥ Grade 3 Per CTCAE v4 Except:|"Grade 3 nausea or Grade 3 vomiting ≤ 72 hours that recovers to grade 0-2 with maximal antiemetic therapy.~Grade 3 diarrhea that resolves to grade 0-2 with loperamide or diphenoxylate/atropine within 48 hours.~Grade 3 hypercholesterolemia, hypertriglyceridemia, hyperglycemia or hypophosphatemia that resolves to grade 0-2 with medical management.~Transient electrolyte abnormalities lasting ≤ 1 week."|Up to week 8|Only 3 patients total enrolled resulting in IRB closure, deemed a failed trial by the Principal Investigator. Data was not validated and PI has no interest in validating the data so it cannot be reported.||||||
2576762|NCT02447848|Secondary|PI at Each Evaluation Time Point|Pain intensity at each evaluation time point after the first dose of study drug up through 5 hours is evaluated using an 11-point NRS where 0 equals no pain and 10 equals worst possible pain. The score was obtained at Baseline, 15- , 30-, 45- minutes, 1-hour, and 2-hours after the first dose for all patients, and at hours 3, 4, and 5 for cohort 2 (patients 41-76). Scores ranged from 0 -10 for the first two hours, and 2 - 10 for hours three to five.|5 hours|The first cohort of patients (N=40) received one dose of study drug and the study was completed at two hours. The second cohort of patients (N=36) had the option of remaining in the study through five hours; most patients discontinued the study at 2 hours.|||units on a scale||Standard Error|Mean
2576763|NCT02447848|Secondary|TOTPAR1 (Time-weighted)|"The total pain relief (TOTPAR) is the time-weighted sum of the pain relief scores over the first hour (15 minutes, 30 minutes, 45 minutes and 1-hour after the first dose of study drug is taken) of the study period.~The minimum score is 0.00 and the maximum score is 4.00. A higher score indicates greater pain relief."|1-hour||||units on a scale||Standard Error|Mean
2576764|NCT02447848|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 1-hour (SPID1).|"The primary efficacy endpoint is the time-weighted SPID1 evaluated from the patient questionnaire data. Pain intensity (PI) will be measured using an 11-point numerical rating scale (NRS) with 0 (no pain) and 10 (worst possible pain).~The patient's rating of PI will be measured at baseline and at 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1, 2, 3, 4, and 5 hours following the first dose of study drug.~The PID at each evaluation time point after the initiation of the first dose is the difference in PI at the specific evaluation time point and baseline pain intensity [PID (evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. The time-weighted SPID1 is the time-weighted summed PID over the 1-hour study period.~The observed SPID scores ranged from -.70 to 8.00. A negative score indicates an increase in pain intensity and a positive score indicates a decrease in pain intensity."|One hour||||units on a scale||Standard Error|Mean
2576765|NCT02447458|Secondary|Renal Clearance (CLr) of MLN3126 and Metabolite M-I|Renal clearance was calculated as CLr=Ae(0-96)/AUC (0-96).|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK urine concentration.|||mL/min||Standard Deviation|Mean
2576766|NCT02447458|Secondary|Fe: Fraction of MLN3126 Excreted in the Urine|Fe is the Fraction of drug excreted in urine, calculated as Fe=(Ae[0-t]/dose)×100.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK urine concentration.|||Percentage||Standard Deviation|Mean
2576767|NCT02447458|Secondary|Ae (0-96): Total Amount of MLN3126 and Metabolite M-I Excreted in the Urine|Ae (0-96) is the total amount of drug excreted in urine from time 0 to time 96 hours.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK urine concentration.|||ng||Standard Deviation|Mean
2576768|NCT02447458|Secondary|T ½: Half-life of MLN3126 and Metabolite M-I|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.|||Hours||Standard Deviation|Mean
2576769|NCT02447458|Secondary|CL/F: Oral Clearance of MLN3126|CL/F is apparent clearance of the drug from the plasma, after extravascular administration.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.|||L/hr||Standard Deviation|Mean
2576770|NCT02447458|Secondary|AUC(0-inf): Area Under the Plasma Concentration Time Curve of MLN3126 and Metabolite M-I From Time 0 to Infinity|AUC(0-inf) is measure of area under the curve from time 0 to infinity.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2576771|NCT02447458|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration Time Curve of MLN3126 and Metabolite M-I From Time 0 to the Last Quantifiable Concentration|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2576772|NCT02447458|Secondary|Tmax: Time to Maximum Plasma Concentration of MLN3126 and Metabolite M-I|Tmax is the time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|PK analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.|||Hours||Full Range|Median
2576773|NCT02447458|Secondary|Cmax: Maximum Plasma Concentration of MLN3126 and Metabolite M-I|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Pre-dose and multiple timepoints post-dose (Up to 96 Hours)|Pharmacokinetic (PK) analysis set included all participants who received study drug and who had at least 1 measurable PK plasma concentration.|||ng/mL||Standard Deviation|Mean
2576774|NCT02447458|Primary|Percentage of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings Post-Dose|A standard 12-lead ECG was performed. The percentage of participants with markedly abnormal electrocardiogram (ECG) findings during the study.|Up to Day 16|Safety population included all enrolled participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2576805|NCT02447081|Secondary|Number of Participants With Oral Anti-coagulation Usage||At 1 to 3 months|The number of participates completing a study visit at the Time Frame|||Participants|||Count of Participants
2576775|NCT02447458|Primary|Percentage of Participants With Markedly Abnormal Vital Signs Post-Dose|Vital signs included oral body temperature measurement, blood pressure, respiration rate, and pulse rate [beats per minute (bpm) or heart rate]. The percentage of participant with markedly abnormal vital signs findings during the study. OBP=Orthostatic Blood Pressure. All OBP measurements were standing.|Up to Day 16|Safety population included all enrolled participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2576776|NCT02447458|Primary|Percentage of Participants With Markedly Abnormal Clinical Laboratory Results Post-Dose|Clinical safety laboratory tests included clinical chemistry, hematology and urinalysis. The percentage of participants with any markedly abnormal laboratory finding during the study.|Up to Day 16|Safety population included all enrolled participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2576777|NCT02447458|Primary|Number of Participants That Experience At Least One Treatment-Emergent Adverse Event (TEAE) Post-Dose|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to Day 22|Safety population included all enrolled participants who received at least 1 dose of study drug.|||Participants|||Number
2576778|NCT02447432|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study|An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.|From Day 0 to Month 9|The analysis was performed on the Total vaccinated cohort of Epoch 001 which included all subjects who had received at least one dose of primary vaccination.|||Participants|||Count of Participants
2576779|NCT02447432|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) (Epoch 001)|An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.|From Month 0 to Month 4|The analysis was performed on the Total vaccinated cohort of Epoch 001 which included all subjects who had received at least one dose of primary vaccination.|||Participants|||Count of Participants
2576780|NCT02447432|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 002)|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post booster vaccination|The analysis was performed on the Total vaccinated cohort of Epoch 002 included all subjects who had received the booster vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited or unsolicited symptoms were available.|||Participants|||Count of Participants
2576781|NCT02447432|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 001)|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post primary vaccination, across doses|The analysis was performed on the Total vaccinated cohort of Epoch 001 which included all subjects who had received at least one dose of primary vaccination.|||Participants|||Count of Participants
2576782|NCT02447432|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002)|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever (axillary route - temperature equal or higher than [≥] 37.5 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (Axillary) temperature higher than (>) 39.5°C.|Within the 4-day (Days 0-3) period after booster vaccination|The analysis was performed on the Total vaccinated cohort of Epoch 002 included all subjects who had received the booster vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited or unsolicited symptoms were available.|||Participants|||Count of Participants
2576806|NCT02447081|Secondary|Number of Participants With Oral Anti-coagulation Usage||At discharge, approximately 1 or 2 days after the procedure|The number of participates completing a study visit at the Time Frame|||Participants|||Count of Participants
2576807|NCT02447081|Secondary|Number of Participants With Procedural Success|Procedural success is based on Amulet device being implanted day 0 through hospital discharge, on average one night stay (day 1). Amulet device implanted and subject discharged the following day without an adverse event|During the implant procedure and hospital stay, approximately 1 or 2 days||||Participants|||Count of Participants
2576783|NCT02447432|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001)|"Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever (axillary route - temperature equal or higher than [≥] 37.5 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (>) 39.5°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Dose 1 = 10Pn-PD-DIT+DTPw-HBV/Hib at 6 weeks of age. Dose 2 = 10Pn-PD-DIT+DTPw-HBV/Hib at 10 weeks of age.~Dose 4 = 10Pn-PD-DIT at 18 weeks of age."|Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine|The analysis was performed on the Total vaccinated cohort of Epoch 001 included all subjects who had received at least one dose of primary vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Participants|||Count of Participants
2576784|NCT02447432|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002)|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within the 4-day (Days 0-3) period after booster vaccination|The analysis was performed on the Total vaccinated cohort of Epoch 002 included all subjects who had received the booster vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited or unsolicited symptoms were available.|||Participants|||Count of Participants
2576785|NCT02447432|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001)|"Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). Dose 1 = 10Pn-PD-DIT+DTPw-HBV/Hib at 6 weeks of age. Dose 2 = 10Pn-PD-DIT+DTPw-HBV/Hib at 10 weeks of age.~Dose 4 = 10Pn-PD-DIT at 18 weeks of age."|Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine|The analysis was performed on the Total vaccinated cohort of Epoch 001 included all subjects who had received at least one dose of primary vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Participants|||Count of Participants
2576786|NCT02447432|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 002)|Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.|At study Month 9, e.g.: at one month post booster vaccination with pneumococcal vaccine|The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 002 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning booster immunogenicity outcomes measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2576787|NCT02447432|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 001)|Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.|At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 001 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning primary immunogenicity outcomes measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2576788|NCT02447432|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002)|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.|At study Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine|The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 002 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning booster immunogenicity outcomes measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2576789|NCT02447432|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001)|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, 19 A ,-19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.|At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 001 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning primary immunogenicity outcomes measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2576808|NCT02447081|Secondary|Number of Participants With Technical Success|Technical success is defined as successful implantation of the Amulet device in the left arterial appendage (LAA).|During implant procedure, approximately 30 to 60 minutes||||Participants|||Count of Participants
2576809|NCT02447081|Primary|Number of Participants With Major Bleeding Events|Clinical events were adjudicated by the CEC as major bleeding events if they met the definition of Type 3 or greater on the Bleeding Academic Research Consortium (BARC) scale.|Implant through 2 years||||Participants|||Count of Participants
2577192|NCT02443402|Secondary|Intensive Care Unit (ICU) Mortality Rate|The total number of subject deaths during ICU stay will be recorded.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
2576790|NCT02447432|Secondary|Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002)|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.|At Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine|The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 002 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning booster immunogenicity outcomes measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2576791|NCT02447432|Primary|Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001)|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Primary outcome results correspond to antibody concentrations for the 10 vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.|At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 001 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning primary immunogenicity outcomes measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2576792|NCT02447328|Primary|Safety(Percentage of Participants With Adverse Events and/or Adverse Drug Reactions)|Percentage of patients with AEs.|Adverse events were collected from treatment initiation to end of the study about 6 months for each patient.|The safety population: All patients given at least one dose of the study treatment will be included. Data from this population will be used for the safety analysis.|||Percentage of participants||95% Confidence Interval|Number
2576793|NCT02447250|Other Pre-specified|Association of Smoke Exposure During Pregnancy and Neonatal Response to Albuterol|Mothers who smoked cigarettes during pregnancy and the rate of albuterol response of their infants|Smoking and second hand smoke exposure history will be obtained at enrollment. Albuterol response will be obtained within one week.|We have data for 9 subjects whose mothers did not smoke and 4 subjects whose mothers smoked|||participants|||Number
2576794|NCT02447250|Other Pre-specified|Maternal BMI at Time of Pregnancy and Likelihood of Positive Response to Albuterol|Maternal BMI will be obtained from her medial record, and she will be asked about weight gain during pregnancy at time of enrollment. Results will be compared for infants born to women with a normal BMI vs. those with obese BMI (>30).|Maternal information collected at enrollment; albuterol response assessed within one week|We have BMI data on 13 mothers.|||kg/m^2||Standard Deviation|Mean
2576795|NCT02447250|Other Pre-specified|Family History of Asthma and Likelihood to Respond to Albuterol|Family history was obtained from verbal history by subject's mother at time of enrollment in study. A positive family history was noted if a first degree relative of the subject (infant) had a diagnosis of asthma.|History collected at enrollment, albuterol response assessed within one week|only 2 subjects had a history of a first-degree relative (parent or sibling) with asthma|||participants|||Number
2576796|NCT02447250|Secondary|Etiology of Preterm Delivery|Reason for each subject's preterm delivery was classified as either preterm labor or delivery for maternal indications (eg pre-eclampsia).|within one week of entering study|5 subjects were delivered due to preterm labor, and 8 delivered prematurely due to maternal indications|||Participants|||Count of Participants
2576797|NCT02447250|Secondary|Gestational Age at Birth|Average gestational age (GA) in weeks at birth for subjects who responded to albuterol versus subjects without a positive response|within one week of entering study|We have data for 10 subjects who responded to albuterol and 3 subjects who did not respond.|||weeks||Standard Deviation|Mean
2576798|NCT02447250|Secondary|Birth Weight of Albuterol Responders vs Non Responders|birth weight in grams of each subject was recorded at time of enrollment|within one week of entering study|This data included 10 subjects who responded to albuterol at at least one dose, and 3 subjects who did not show a positive response to albuterol at any dose|||grams||Standard Deviation|Mean
2576799|NCT02447250|Secondary|Number of Participants With Positive Response at Different Albuterol Doses|Compare number of subjects who have a positive response (greater than or equal to 10% decrease in respiratory resistance) to each dose of albuterol|Data collected 15 minutes after dose in each session. Study includes 3 sessions within a 7 day period.|Measuring Rrs can be technically challenging, particularly in premature infants, and we did not have measurable Rrs for every subject at every time point, therefore the denominator here is not the same as the total number of participants. For example, we have missing/unmeasurable Rrs for 3 subjects at the lowest albuterol dose.|||participants|||Number
2576800|NCT02447250|Primary|Change in Respiratory Resistance|The primary outcome is the percentage of subjects who show a positive response to each dose of albuterol. A positive response is defined as a greater than or equal to 10% decrease in respiratory resistance (Rrs). The change in RRs was measured at baseline and again after each dose of albuterol. All measurements were taken within a 7 day time frame for each subject such that each subject would have up to 3 results measured during a 7 day period, if he/she were able to complete three sets of PFTs according to study protocol. The change in Rrs was calculated by subtracting the baseline Rrs from the post-albuterol Rrs.|Within one week of performing pulmonary function tests|Some subjects did not receive all 3 doses (based on how they tolerated initial dose(s))|||cm h2o/mL/sec||Standard Deviation|Mean
2576801|NCT02447133|Primary|TopQ Cut Off|To validate the values of the predetermined TopQ score by showing the variability above and below the TopQ score of 25 for 12x9 Wide, 28 for 6x6 Macula, and 30 for 6x6 Disc scans.|1 hour|use of 12 subjects for 3 different scan patterns|||microns|||Number
2576802|NCT02447081|Secondary|Number of Participants With Oral Anti-coagulation Usage||At 24 months||||Participants|||Count of Participants
2581470|NCT02392208|Primary|CLobs of Telavancin|Observed clearance of telavancin|At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48||||mL/h/kg||Standard Deviation|Mean
2576814|NCT02447029|Secondary|Overall Satisfaction With Procedure as Measured by a Visual Analog Scale|This is the level of overall satisfaction self-reported by the patient at the completion of the procedure and prior to discharge. VAS ranged from 0 to 100 mm, 0 equals not satisfied, 100 equals highest satisfaction possible.|30-45 minutes after completion of procedure|All treated patients were included in the analysis|||units on a scale||Inter-Quartile Range|Median
2576815|NCT02447029|Secondary|Pain 30-45 Minutes After Procedure as Measured by a Visual Analog Scale|This is the amount of pain self-reported by the patient 30-45 minutes after procedure. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.|Pain prior to discharge home: 30-45 minutes after completion of procedure|All treated patients were included in the analysis|||units on a scale||Inter-Quartile Range|Median
2576816|NCT02447029|Secondary|Pain With Tenaculum Placement as Measured by a Visual Analog Scale|This is the amount of pain self-reported by the patient at the time of tenaculum placement. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.|Pain at time of tenaculum placement|All treated patients were included in the analysis|||units on a scale||Standard Deviation|Mean
2576817|NCT02447029|Secondary|Pain With Speculum Insertion as Measured by a Visual Analog Scale|This is the amount of pain self-reported by the patient at the time of speculum insertion. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.|Pain at time of speculum insertion|Treated patients were included in the analysis|||units on a scale||Standard Deviation|Mean
2576818|NCT02447029|Secondary|Pain Level Prior to Procedure (Anticipated Pain) as Measured by a Visual Analog Scale|This is the amount of pain self-reported by the patient prior to the procedure (Anticipated pain). VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.|Pain level prior to procedure|Treated patients were included in the analysis|||units on a scale||Inter-Quartile Range|Median
2576819|NCT02447029|Primary|Difference in Pain Level at Time of Cervical Dilation as Measured by a Visual Analog Scale|This is the amount of pain self-reported by the patient at the time of cervical dilation. VAS ranged from 0 to 100 mm, 0 equals no pain, 100 equals worse pain imaginable.|At time of cervical dilation, 30 minutes after lidocaine administration|Treated participants were included in the analysis.|||units on a scale||Inter-Quartile Range|Median
2576820|NCT02446990|Secondary|Secondary Composite Endpoint|Non-fatal myocardial infarction, coronary revascularisation, unstable angina|From the date of randomisation to the date of first occurrence of the event, up to 48 months||||participants|||Number
2576821|NCT02446990|Secondary|Secondary Composite Endpoint|Coronary death, non-fatal myocardial infarction|From the date of randomisation to the date of first occurrence of the event, up to 48 months||||participants|||Number
2576822|NCT02446990|Secondary|Secondary Composite Endpoint|Cardiovascular death, non-fatal myocardial infarction, non-fatal stroke|From the date of randomisation to the date of first occurrence of the event, up to 48 months||||participants|||Number
2576823|NCT02446990|Secondary|Secondary Composite Endpoint|Fatal or non-fatal myocardial infarction, coronary revascularisation, unstable angina|From the date of randomisation to the date of first occurrence of the event, up to 48 months||||participants|||Number
2576824|NCT02446990|Secondary|Secondary Composite Endpoint|Fatal or non-fatal myocardial infarction, coronary revascularisation|From the date of randomisation to the date of first occurrence of the event, up to 48 months||||participants|||Number
2576825|NCT02446990|Secondary|Secondary Composite Endpoint|Fatal or non-fatal myocardial infarction|From the date of randomisation to the date of first occurrence of the event, up to 48 months||||participants|||Number
2576826|NCT02446990|Secondary|Coronary Revascularisation (Elective or Not)|Non-composite secondary endpoint|From the date of randomisation to the date of first occurrence of the event, up to 48 months||||participants|||Number
2576827|NCT02446990|Secondary|Elective Coronary Revascularisation|Non-composite secondary endpoint|From the date of randomisation to the date of first occurrence of the event, up to 48 months||||participants|||Number
2576828|NCT02446990|Secondary|Non-fatal Myocardial Infarction|Component of the primary composite endpoint|From the date of randomisation to the date of first occurrence of the event, up to 48 months||||participants|||Number
2576829|NCT02446990|Secondary|Fatal Myocardial Infarction|Non-composite secondary endpoint|From the date of randomisation to death, up to 48 months||||participants|||Number
2576830|NCT02446990|Secondary|Coronary Mortality|Coronary mortality including sudden death of unknown cause, death from myocardial infarction, death from heart failure, death from coronary artery procedure, presumed arrhythmic death|From the date of randomisation to death, up to 48 months||||participants|||Number
2576831|NCT02446990|Secondary|Cardiovascular Mortality|Component of the primary composite endpoint|From the date of randomisation to death, up to 48 months||||participants|||Number
2576832|NCT02446990|Secondary|All-cause Mortality||From the date of randomisation to death, up to 48 months||||participants|||Number
2576833|NCT02446990|Primary|Primary Composite Endpoint|First event among cardiovascular death or non-fatal myocardial infarction|The events are expressed as the time to occurrence of the first event, defined as the duration between the date of randomisation and the date of first occurrence of event, assessed up to 48 months.||||participants|||Number
2576834|NCT02446912|Secondary|Change From Baseline in Personal Health Questionnaire Depression Scale-8 (PHQ-8) Score|PHQ-8 is a 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. PHQ-8 assesses symptoms of depression over the previous 2 weeks. Higher scores indicate more depressive symptoms. A negative change from baseline score indicates improvement in symptoms.|Baseline to Week 52|All participants who received study drug with non-missing baseline and week 52 measurements.|||Score on a Scale||Standard Deviation|Mean
2576844|NCT02446912|Secondary|Number of Participants Who Met the Criteria for British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response (Original Analysis With Restricted Medication Rules)|"A BICLA responder was achieved if all of the following criteria was met:~All criteria related to SRI(4) (please see primary endpoint) plus:~Reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by 1 or more BILAG-2004 A or 1 or more new BILAG-2004 B item No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc analysis threshold before assessment."|Week 52|Full analysis set - all randomized participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2576835|NCT02446912|Secondary|Number of Participants With Suicidal Ideation or Behaviour Assessed Via the Columbia Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Number of participants with suicidal ideation or behavior was defined as the number of participants who answered yes at any time during the treatment period (Baseline to Week 52) to one of the 10 categories:~Category 1: Wish to be dead Category 2: Non-specific active suicidal thoughts Category 3: Active suicidal ideation with any methods (not plan) without intent to act Category 4: Active suicidal ideation with some intent to act, without specific plan Category 5: Active suicidal ideation with specific plan and intent Category 6: Preparatory acts or behavior Category 7: Aborted attempt Category 8: Interrupted attempt Category 9: Actual attempt (non-fatal) Category 10: Completed suicide"|Baseline to Week 52|Full analysis set - all randomized participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2576836|NCT02446912|Secondary|Number of Participants With Markedly Abnormal Laboratory Tests|Laboratory tests were collected at central clinical laboratories and included hematology, serum chemistry and urinalysis tests. Laboratory values were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE).|Baseline to End of Trial (Maximum of 60 weeks)|Full analysis set - all randomized participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2576837|NCT02446912|Secondary|Number of Participants With Mild To Moderate Lupus Flare Evaluated by Modified Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI Flare Index|"The modified SELENA flare index was completed by the Investigator or delegated/qualified physician. Assessment of flares were scored in comparison to the participant's previous visit and should only include findings which, in the opinion of the Investigator, are due to systemic lupus erythematosus (SLE) disease activity within that timeframe. Flare was defined as any 1 criterion present in either the Mild/Moderate Flare or Severe Flare categories.~Number of flares were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE)."|Baseline to End of Trial (Maximum of 60 weeks)|Full analysis set - all randomized participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2576838|NCT02446912|Secondary|Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Scores|ECGs documented the date, time, heart rate, QRS duration, PR interval, RR interval, QT, and corrected QT interval, which were calculated using the Fridericia formula. The investigator judged the overall interpretation as normal or abnormal, and if abnormal it was decided as to whether or not the abnormality was clinically significant or not clinically significant.|Baseline to Week 52|Full analysis set - all randomized participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2576839|NCT02446912|Secondary|Number of Participants With Markedly Abnormal Physical Examinations|"Physical examinations included height and weight. Participants were weighed at each study visit and any medically significant changes were reported.~Physical examination values were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE)."|Baseline to End of Trial (Maximum of 60 weeks)|Full analysis set - all randomized participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2576840|NCT02446912|Secondary|Number of Participants With Markedly Abnormal Vital Signs|"Vital signs included oral temperature, blood pressure (BP), pulse rate, and respiratory rate.~Vital signs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE)."|Baseline to End of Trial (Maximum of 60 weeks)|Full analysis set - all randomized participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2576841|NCT02446912|Secondary|Number of Participants Reporting One or More Adverse Events of Special Interest (AESI)|"An AESI is an AE of scientific and medical concern specific to understanding biologics and requires close monitoring and rapid communication by the Investigator to the Sponsor/Sponsor's delegate. An AESI may be serious or nonserious. The events of interest are serious infections, including non opportunistic serious infections, opportunistic infections, anaphylaxis, malignancy, herpes zoster, TB (including latent TB), influenza, vasculitis (non-SLE), and MACE (including stroke, MI, or cardiovascular death).~AEs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE)."|Baseline to End of Trial (Maximum of 60 weeks)|Full analysis set - all randomized participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2576842|NCT02446912|Secondary|Number of Participants Reporting One or More Adverse Events (AE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. AEs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). The reported value is inclusive of serious and non-serious AEs.|Baseline to End of Trial (Maximum of 60 weeks)|Full analysis set - all randomized participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2576843|NCT02446912|Post-Hoc|Number of Participants Who Met the Criteria for British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response (Post-Hoc Analysis With Revised Restricted Medication Rules)|"A BICLA responder was achieved if all of the following criteria was met:~All criteria related to SRI(4) (please see primary endpoint) plus:~Reduction of all baseline BILAG-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by 1 or more BILAG-2004 A or 1 or more new BILAG-2004 B item No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc analysis threshold before assessment.~Revised rules were designed to be more clinically appropriate, capture intent of protocol, minimize the risk of restricted medications confounding efficacy, and to allow appropriate quantification and interpretation of the relevant endpoints."|Week 52|Full analysis set - all randomized participants who received at least one dose of investigation product.|||Participants|||Count of Participants
2576845|NCT02446912|Secondary|Annualized Flare Rate|A flare was defined as either 1 or more new British Isle Lupus Assessment Group (BILAG-2004) A or 2 or more new BILAG-2004 B items compared to the previous visit. The occurrence of a new flare was checked for each available visit versus the previous available visit up to Week 52. If no new flares occurred, the number of flares was set to 0. Otherwise all flares were counted leading to the maximum number of flares of 13. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25 (1 year). The flare exposure time is the time up to Week 52 (date of BILAG-2004 assessment at Week 52) or up to the date of last available BILAG-2004 assessment.|Baseline to Week 52|Full analysis set - all randomized participants who received investigational product with non-missing baseline measurements.|||Annualized flare rate ratio|||Number
2576846|NCT02446912|Post-Hoc|Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index of ≥4 (SRI[4]) at Week 24 (Post-Hoc Analysis With Revised Restricted Medication Rules)|"SRI(4) was defined as meeting all of the following criteria:~Reduction from baseline of ≥4 points in the SLEDAI-2K No new organ systems affected, defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B items No worsening from baseline in lupus disease activity. Worsening defined as an increase of ≥0.30 points on a 3-point PGA VAS No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc allowed threshold.~Revised rules were designed to be more clinically appropriate, capture intent of protocol, minimize the risk of restricted medications confounding efficacy, and to allow appropriate quantification and interpretation of the relevant endpoints."|Week 24|Full analysis set - all randomized participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2576847|NCT02446912|Secondary|Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index of ≥4 (SRI[4]) at Week 24 (Original Analysis With Restricted Medication Rules)|"SRI(4) was defined as meeting all of the following criteria:~Reduction from baseline of ≥4 points in the SLEDAI-2K No new organ systems affected as defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B items No worsening from baseline in participants lupus disease activity. Worsening was defined as an increase of ≥0.30 points on a 3-point PGA VAS No discontinuation of investigational product and no use of restricted medications beyond the pre-specified threshold."|Week 24|Full analysis set - all randomized participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2576848|NCT02446912|Post-Hoc|Number of Participants With a ≥50% Reduction in CLASI Activity Score at Week 12 in the Sub-group of Participants With Baseline CLASI Activity Score ≥10 (Post-Hoc Analysis With Revised Restricted Medication Rules)|"50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score compared to baseline was defined by meeting all the following criteria:~Achieve ≥50% reduction of CLASI activity score at Week 12 compared to baseline No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc analysis threshold before assessment.~Revised rules were designed to be more clinically appropriate, capture intent of protocol, minimize the risk of restricted medication confounding efficacy, and to allow appropriate quantification and interpretation of the relevant endpoints."|Week 12|All participants who received investigational product, had a baseline CLASI Activity Score ≥10, and had non-missing baseline measurements.|||Participants|||Count of Participants
2576849|NCT02446912|Secondary|Number of Participants With a ≥50% Reduction in CLASI Activity Score at Week 12 in the Sub-group of Participants With Baseline CLASI Activity Score ≥10 (Original Analysis With Restricted Medication Rules)|"50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score compared to baseline was defined by meeting all of the following criteria:~Achieve ≥50% reduction of CLASI activity score at Week 12 compared to baseline No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold before assessment."|Week 12|All participants who received investigational product, had a baseline CLASI Activity Score ≥10, and had non-missing baseline measurements.|||Participants|||Count of Participants
2576850|NCT02446912|Post-Hoc|Number of Participants Who Achieved and Maintained an Oral Corticosteroid (OCS) Dose of ≤7.5 mg/Day in the Sub-group of Participants With Baseline OCS ≥10 mg/Day (Post-Hoc Analysis With Revised Restricted Medication Rules)|"Maintained OCS reduction was defined by meeting all of the following criteria:~Achieve an OCS dose of ≤7.5 mg/day prednisone or equivalent by Week 40 Maintain an OCS dose ≤7.5 mg/day prednisone or equivalent from Week 40 to Week 52 No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc analysis threshold.~Revised rules were designed to be more clinically appropriate, capture intent of protocol, minimize the risk of restricted medication confounding efficacy, and to allow appropriate quantification and interpretation of the relevant endpoints."|Week 52|All participants who received investigational product, who had a baseline OCS ≥10 mg/day, and had non-missing baseline measurements.|||Participants|||Count of Participants
2576851|NCT02446912|Secondary|Number of Participants Who Achieved and Maintained an Oral Corticosteroid (OCS) Dose of ≤7.5 mg/Day in the Sub-group of Participants With Baseline OCS ≥10 mg/Day (Original Analysis With Restricted Medication Rules)|"Maintained OCS reduction was defined by meeting all the following criteria:~Achieve an OCS dose of ≤7.5 mg/day prednisone or equivalent by Week 40 Maintain an OCS dose ≤7.5 mg/day prednisone or equivalent from Week 40 to Week 52 No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold."|Week 52|All participants who received investigational product, who had a baseline OCS ≥10 mg/day, and had non-missing baseline measurements.|||Participants|||Count of Participants
2576852|NCT02446912|Post-Hoc|Number of Participants Who Achieved an Systemic Lupus Erythematosus (SLE) Responder Index of ≥4 at Week 52 in the Interferon (IFN) Test-High Sub-Group (Post-Hoc Analysis With Revised Restricted Medication Rules)|"SRI(4) was defined as meeting all of the following criteria:~Reduction from baseline of ≥4 points in the SLEDAI-2K No new organ systems affected, defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B items No worsening from baseline in lupus disease activity. Worsening defined as an increase of ≥0.30 points on a 3-point PGA VAS No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc analysis threshold.~Revised rules were designed to be more clinically appropriate, capture intent of protocol, minimize the risk of restricted medications confounding efficacy, and to allow appropriate quantification and interpretation of the relevant endpoints."|Week 52|All participants who received investigational product with non-missing baseline measurements, and high IFN test results.|||Participants|||Count of Participants
2576853|NCT02446912|Secondary|Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index of ≥4 at Week 52 in the Interferon (IFN) Test-High Sub-Group (Original Analysis With Restricted Medication Rules)|"SRI(4) was defined as meeting all of the following criteria:~Reduction from baseline of ≥4 points in the SLEDAI-2K No new organ systems affected, defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B No worsening from baseline in participants lupus disease activity. Worsening was defined as an increase of ≥0.30 points on a 3-point PGA VAS No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold."|Week 52|All participants who received investigational product with non-missing baseline measurements, and high IFN test results.|||Participants|||Count of Participants
2576854|NCT02446912|Post-Hoc|Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index ≥4 (SRI[4]) at Week 52 (Post-Hoc Analysis With Revised Restricted Medication Rules)|"SRI(4) was defined as meeting all of the following criteria:~Reduction from baseline of ≥4 points in the SLEDAI-2K No new organ systems affected, defined by 1 or more BILAG-2004 A or 2 or more BILAG-2004 B items No worsening from baseline in lupus disease activity. Worsening defined as an increase of ≥0.30 points on a 3-point PGA VAS No discontinuation of investigational product and no use of restricted medications beyond the revised post-hoc allowed threshold.~Revised rules were designed to be more clinically appropriate, capture intent of protocol, minimize the risk of restricted medications confounding efficacy, and to allow appropriate quantification and interpretation of the relevant endpoints."|Week 52|Full analysis set - all randomized participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2576855|NCT02446912|Primary|Number of Participants Who Achieved a Systemic Lupus Erythematosus (SLE) Responder Index ≥4 (SRI[4]) at Week 52 (Original Analysis With Restricted Medication Rules)|"SRI(4) was defined as meeting all of the following criteria:~Reduction from baseline of ≥4 points in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) No new organ systems affected, defined by 1 or more British Isles Lupus Assessment Group (BILAG-2004) A or 2 or more BILAG-2004 B items No worsening from baseline in participants lupus disease activity. Worsening was defined as an increase of ≥0.30 points on a 3-point Physician's Global Assessment (PGA) visual analogue scale (VAS) No discontinuation of investigational product and no use of restricted medications beyond the pre-specified analysis threshold."|Week 52|Full analysis set - all randomized participants who received at least one dose of investigational product.|||Participants|||Count of Participants
2576856|NCT02446899|Secondary|Number of Participants With a Potentially Clinically Important Change From Baseline in Clinical Laboratory Tests|"Clinical laboratory tests were analyzed in a central clinical laboratory and included hematology, serum chemistry and urinalysis tests.~Laboratory values were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE)."|Baseline to end of study (Maximum of 60 weeks)|Full Analysis Set: All participants who were randomized and received at least one dose of study drug.|||Participants|||Count of Participants
2576857|NCT02446899|Secondary|Number of Participants With a Potentially Clinically Important Change From Baseline in Vital Sign Measurements|"Vital sign measurements included oral temperature, blood pressure (BP), pulse rate, and respiratory rate.~Vital signs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE)."|Baseline to end of study (Maximum of 60 weeks)|Full Analysis Set: All participants who were randomized and received at least one dose of study drug.|||Participants|||Count of Participants
2576858|NCT02446899|Secondary|Number of Participants With One or More Adverse Events of Special Interest (AESIs)|"An AESI is an adverse event (AE) of scientific and medical concern specific to understanding biologics. An AESI may be serious or non-serious. AESI are serious infections, including non-opportunistic serious infections, opportunistic infections, anaphylaxis, malignancy, herpes zoster, tuberculosis (TB) (including latent TB), influenza, vasculitis (non-systemic lupus erythematosus [SLE]), and major adverse cardiovascular events (MACE) (including stroke, myocardial infarction [MI], or cardiovascular death).~AESIs were collected throughout the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE)."|Baseline to end of study (Maximum of 60 weeks)|Full Analysis Set: All participants who were randomized and received at least one dose of study drug.|||Participants|||Count of Participants
2576859|NCT02446899|Secondary|Number of Participants With One or More Adverse Events (AEs)|An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. AEs were collected throughout the duration of the study, from baseline until end of follow-up (a maximum of 12 weeks post last dose [Week 48]), or until Week 52 for participants who enrolled onto the long term extension (LTE). The reported value is inclusive of serious and non-serious AEs.|Baseline to end of study (Maximum of 60 weeks)|Full Analysis Set: All participants who were randomized and received at least one dose of study drug.|||Participants|||Count of Participants
2576860|NCT02446899|Secondary|Annualised Flare Rate Through 52 Weeks|A flare was defined as either 1 or more new British Isle Lupus Assessment Group (BILAG-2004) A or 2 or more new BILAG-2004 B items compared to the previous visit. The occurrence of a new flare was checked for each available visit versus the previous available visit up to Week 52. If no new flares occurred, the number of flares was set to 0. Otherwise all flares were counted leading to the maximum number of flares of 13. The annualized flare rate was calculated as the number of flares divided by the flare exposure time in days multiplied with 365.25 (1 year). The flare exposure time is the time up to Week 52 (date of BILAG-2004 assessment at Week 52) or up to the date of last available BILAG-2004 assessment.|Baseline to Week 52|Full Analysis Set: All participants who were randomized and received at least one dose of study drug.|||Annualized flare rate ratio||95% Confidence Interval|Number
2576952|NCT02446314|Primary|Proportion of Words Correctly Recognised.|Participants indicate whether words presented on a monitor are from a list of 15 words previously presented auditorily (via headphones), or if they are novel foils.|12, and 24 weeks||||proportion of words correctly recognised||Standard Error|Mean
2577193|NCT02443402|Secondary|Hospital Mortality Rate|The total number of subject deaths during hospital stay will be recorded.|Post-Surgery (Up to 10 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
2576861|NCT02446899|Secondary|Number of Participants With ≥50% Reduction in Joint Counts at Week 52 in The Sub-group of Participants With ≥6 Swollen and ≥6 Tender Joints at Baseline|"50% reduction in the number of swollen and tender joints compared to baseline was defined by meeting all of the following criteria:~Achieve ≥50% reduction from baseline in the number of swollen and tender joints, separately~No discontinuation of investigational product~No use of restricted medications beyond the protocol allowed threshold before assessment"|Baseline; Week 52|Full Analysis Set: All participants who were randomized and received at least one dose of study drug, and who had ≥6 swollen and ≥6 tender joints at baseline.|||Participants|||Count of Participants
2576862|NCT02446899|Secondary|Number of Participants With a ≥50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12 in The Sub-Group of Participants With Baseline CLASI Activity Score of ≥10|"50% reduction in CLASI activity score compared to baseline was defined by meeting all of the following criteria:~Achieve ≥50% reduction of CLASI activity score at Week 12 compared to baseline~No discontinuation of investigational product~No use of restricted medications beyond the protocol allowed threshold before assessment"|Baseline; Week 12|Full Analysis Set: All participants who were randomized and received at least one dose of study drug, and who had a CLASI activity score of ≥10 at baseline.|||Participants|||Count of Participants
2576863|NCT02446899|Secondary|Number of Participants Who Achieved and Maintained an Oral Corticosteroids (OCS) Dose of ≤7.5 mg/Day at Week 52 in the Sub-Group of Participants With Baseline OCS ≥10 mg/Day|"Maintained OCS reduction was defined by meeting all of the following criteria:~Achieve an OCS dose of ≤7.5 mg/day prednisone or equivalent by Week 40~Maintain an OCS dose ≤7.5 mg/day prednisone or equivalent from Week 40 to Week 52~No discontinuation of investigational product~No use of restricted medications beyond the protocol allowed threshold before assessment"|Week 40; Week 52|Full Analysis Set: All participants who were randomized and received at least one dose of study drug, who had a baseline OCS dose of ≥10 mg/day.|||Participants|||Count of Participants
2576864|NCT02446899|Secondary|Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52 in the IFN Test-High Sub-group|"Defined by meeting all of the following criteria:~Reduction of all baseline British Isles Lupus Assessment Group (BILAG)-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B~No worsening from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), where worsening is defined as an increase from baseline to >0 points in SLEDAI-2K~No worsening from baseline in participants' lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point Physician's Global Assessment (PGA) visual analogue scale (VAS)~No discontinuation of investigational product~No use of restricted medications beyond the protocol allowed threshold before assessment"|Baseline; Week 52|Full Analysis Set: All participants who were randomized and received at least one dose of study drug, with a high interferon (IFN) test result at baseline.|||Participants|||Count of Participants
2576865|NCT02446899|Primary|Number of Participants Who Achieved the British Isles Lupus Assessment Group Based Composite Lupus Assessment (BICLA) Response at Week 52|"Composite endpoint BICLA was defined by meeting all of the following criteria:~Reduction of all baseline British Isles Lupus Assessment Group (BILAG)-2004 A to B/C/D and baseline BILAG-2004 B to C/D, and no BILAG-2004 worsening in other organ systems, as defined by ≥1 new BILAG-2004 A or ≥2 new BILAG-2004 B~No worsening from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), where worsening is defined as an increase from baseline of >0 points in SLEDAI-2K~No worsening from baseline in participants' lupus disease activity, where worsening is defined by an increase ≥0.30 points on a 3-point Physician's Global Assessment (PGA) visual analogue scale (VAS)~No discontinuation of investigational product~No use of restricted medications beyond the protocol allowed threshold before assessment"|Baseline; Week 52|Full Analysis Set: All participants who were randomized and received at least one dose of study drug.|||Participants|||Count of Participants
2576866|NCT02446769|Secondary|Number of Hospitalizations Over 3 Years (Optional if Enrolled in Registry)|Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of emergent and non-emergent healthcare utilization over 6 months; costs related to re-hospitalization; number of visits to physician offices or emergency rooms, and health-related quality of life (disease-specific and general HR-QOL measures).|3 years|Data could not be analyzed because no participants enrolled in the registry.||||||
2576867|NCT02446769|Secondary|Time to Re-hospitalization Alone|Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of emergent and non-emergent healthcare utilization over 6 months; costs related to re-hospitalization; number of visits to physician offices or emergency rooms, and health-related quality of life (disease-specific and general HR-QOL measures).|60 days post-discharge|Data was collected however data could not be analyzed because too few participants completed each arm to assess the average time to re-hospitalization.||||||
2576868|NCT02446769|Secondary|Composite End-point of Time to Occurrence of Non-emergent Healthcare Utilization (Such as Scheduled Hospitalization, Scheduled Physician Office, Urgent Care Visits or Emergency Room Visits).|Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of emergent and non-emergent healthcare utilization over 6 months; costs related to re-hospitalization; number of visits to physician offices or emergency rooms, and health-related quality of life (disease-specific and general HR-QOL measures).|60 days post-discharge|Data was collected however data could not be analyzed because too few participants completed each arm to assess non-emergent healthcare utilization.||||||
2576877|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:8 After Second Vaccination of rMenB+OMV NZ.|"Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.~Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure."|At Day 61 (30 days post second vaccination)|Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
2577194|NCT02443402|Secondary|Number of Participants With Blood Glucose Less Than 40 mg/dl|Number of participants with blood glucose (BG) <40 throughout the duration of hospitalization.|Duration of Hospitalization (Up to 30 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
2576869|NCT02446769|Secondary|Change in Quality of Life (FOSQ) at 30 and 60 Days|"FOSQ is a quality of life questionnaire for sleep disorders. It's a 30 question survey with 5 subgroups: general productivity (8 questions), social outcome (2 questions),activity level (9 questions), vigilance (7 questions) and intimate relationships & sexual activity (4 questions).~Scores are provided on a 0 to 4 scale:~0- I don't do this activity for other reasons or missing response~1- Yes, extreme difficulty 4- no difficulty The average score was calculated based upon average sub-scores. The total score was, calculated using the mean of the subscale scores and multiplying the mean by the number of subscales. The range of scores for the total score is 5-20. The measures are designed to assess the impact of disorders of excessive sleepiness on activities of everyday living and the extent to which these abilities are improved by effective treatment. The lower the score the more difficulty a person has carrying out certain activities because they are too sleepy or tired."|30 and 60 days post-discharge|Data was collected however data could not be analyzed because too few participants completed each arm to assess the change in quality of life.||||||
2576870|NCT02446769|Secondary|Change in Quality of Life (SF-36) at 30 and 60 Days|Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of emergent and non-emergent healthcare utilization over 6 months; costs related to re-hospitalization; number of visits to physician offices or emergency rooms, and health-related quality of life (disease-specific and general HR-QOL measures). The Short Form 36 (SF-36) is a set of quality of life measures. Scoring for this is a two step process, scores are converted to answers of zero to 100. Those scores are than averaged based upon category so that the lowest possible score is zero and highest possible score is 100. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|30 and 60 days post-discharge|Data was collected however data could not be analyzed because too few participants completed each arm to assess the measure changes in the quality of life.||||||
2576871|NCT02446769|Secondary|Healthcare Costs|Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of emergent and non-emergent healthcare utilization over 6 months; costs related to re-hospitalization; number of visits to physician offices or emergency rooms, and health-related quality of life (disease-specific and general HR-QOL measures).|60 days post-discharge|Data was collected however data could not be analyzed because too few participants completed each arm to assess healthcare costs.||||||
2576872|NCT02446769|Primary|Composite End-point of Time to Occurrence of Emergent Healthcare Utilization (Such as Re-hospitalization, Unscheduled Physician Office Visits, Urgent Care Visits or Emergency Room Visits).|Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on time to (# of days) emergent and non-emergent healthcare utilization in patients with sleep-disordered breathing who are hospitalized with co-morbid Chronic Obstructive Pulmonary Disease (COPD).|60 days post-discharge|Data was collected however data could not be analyzed because too few participants completed each arm to assess the amount of emergent healthcare utilization.||||||
2576873|NCT02446743|Secondary|Percentages of Subjects With at Least Four-fold Increase in hSBA Titers at Pre-First Vaccination Compared to One Month Post-Second Vaccination|"The percentage of subjects with 4-fold rise at one month post-vaccination with a second dose (naïve subjects) of rMenB+OMV NZ with respect to day 1, to each and any one, two, three or all 4 indicator strains.~Percentage of subjects with four-fold rise in hSBA titers relative to baseline were defined as:~for a pre-vaccination titer < 4, a post-vaccination titer of at least 16;~for a pre-vaccination titer ≥ 4 but <LLOQ, a post vaccination titer of at least fourfold the LLOQ;~for a pre-vaccination titer ≥LLOQ, a post vaccination titer of at least fourfold the pre-vaccination titer.~Only subjects receiving the second dose of vaccination(group B_0_1) were considered for this outcome measure."|At Day 61 (30 days post second dose of vaccination)|Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain.|||Percentage of Subjects||95% Confidence Interval|Number
2576874|NCT02446743|Secondary|Geometric Mean Ratio (GMRs) of GMTs One Month Post Second Vaccination Versus Pre Vaccination at Day 1|"Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.~Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure."|At Day 1 & Day 61 (30 days post 2nd vaccination)|Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain.|||Ratio||95% Confidence Interval|Geometric Mean
2576875|NCT02446743|Secondary|hSBA Geometric Mean Titers (GMTs) After Second Vaccination of rMenB+OMV NZ.|"Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.~Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure."|At Day 1 & Day 61 (30 days post second dose of vaccination)|Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain.|||Titers||95% Confidence Interval|Geometric Mean
2576876|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:16 After Second Vaccination of rMenB+OMV NZ.|"Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.~Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure."|At Day 61 (30 days post second vaccination)|Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
2576949|NCT02446314|Secondary|Combined Z Score of Mean Reaction Time Scores for Incongruent Attention Network and Stroop Task Trials.|Combined Z Score of Mean Reaction Time Scores for Incongruent Attention Network and Stroop Task Trials. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. A negative change value reflects a decrease in memory or a worse outcome and a positive change value reflects an increase in memory or a better outcome.|12, and 24 weeks||||z-score||Standard Error|Mean
2576878|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:5 After Second Vaccination of rMenB+OMV NZ|Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76 and M10713. Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure.|At Day 61 (30 days post second dose of vaccination.)|Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain. The analysis was performed only on strains H44/76 and M10713|||Percentage of subjects||95% Confidence Interval|Number
2576879|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:4 After Second Vaccination of rMenB+OMV NZ|Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. Only subjects receiving a second vaccination (group B_0_1) were assessed for this outcome measure.|At Day 61 (30 days post second dose of vaccination.)|Analysis was performed on the PPS( per protocol set) catch up. The PPS catch up included all subjects who were randomized to group B_0_1 who correctly received two vaccinations at day 1 and day 31 & provided evaluable immunogenicity result at day 61 for atleast one indicator strain. The analysis was performed only on strains 5/99 and NZ98/254|||Percentage of subjects||95% Confidence Interval|Number
2576880|NCT02446743|Secondary|Percentages of Subjects With at Least Four-fold Increase in hSBA Titers Pre-booster/Second Dose Vaccination- Compared to 3, 7 and 30 Days Post- Booster/Second Vaccination|The percentage of subjects with 4-fold rise at 3, 7, 30 days post-vaccination with a booster dose (follow-on subjects) /second dose (naive subjects) of rMenB+OMV NZ with respect to day 1 (follow-on subjects) / pre-second dose of rMenB+OMV NZ (naïve subjects). Percentage of subjects with four-fold rise in hSBA titers relative to baseline were defined as: • for a pre-vaccination titer < 4, a post-vaccination titer of at least 16; • for a pre-vaccination titer ≥ 4 but <LLOQ, a post vaccination titer of at least fourfold the LLOQ; • for a pre-vaccination titer ≥LLOQ, a post vaccination titer of at least fourfold the pre-vaccination titer.|Group 3B: at 3, 7 and 30 days after third dose booster; Group B_0_1: at 3 (group B_0_1_1 only), 7 (group B_0_1_2 only) and 30 days post second dose|Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion & correctly received the vaccination at day 1/day 31 & day 1 & provided evaluable immunogenicity result at all of days 4, 8 & 31 (follow-on subjects)or at all of days 34/38 & 61(naive)|||Percentage of subjects||95% Confidence Interval|Number
2576881|NCT02446743|Secondary|Geometric Mean Ratios (GMRs) of GMTs After Booster/Second Vaccination Versus Before Booster/Second Vaccination.|Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713 by calculating the GMRs of GMTs post-vaccination with a booster dose (Group 3B) versus pre-booster dose or second dose (Group B_0_1) of vaccination versus pre second dose.|Group 3B: Day 1 and 30 days after third dose booster; Group B_0_1: 30 days post-first dose and at 30 days post-second dose|Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion & correctly received the vaccination at day 1/day 31 & day 1 & provided evaluable immunogenicity result at all of days 4, 8 & 31 (follow-on subjects)or at all of days 34, 38 & 61(naive)|||Ratio||95% Confidence Interval|Geometric Mean
2576882|NCT02446743|Secondary|hSBA Geometric Mean Titers Prior to Booster/Second Dose of Vaccination & Post Booster/Second Dose of Vaccination.|"Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points:~Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose."|Group 3B: Day 1 (pre-booster dose) and 3, 7 and 30 days after third dose booster; Group B_0_1: Pre 2nd dose and at 3 (group B_0_1_1 only), 7 (group B_0_1_2 only) and 30 days post second dose.|Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion & correctly received the vaccination at day 1/day 31 & day 1 & provided evaluable immunogenicity result at all of days 4, 8 & 31 (follow-on subjects)or at all of days 34, 38 & 61(naive)|||Titers||95% Confidence Interval|Geometric Mean
2576883|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:16 After Booster Dose/Second Vaccination of rMenB+OMV NZ|"Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points:~Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose"|Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose|Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion & correctly received the vaccination at day 1/day 31 & day 1 & provided evaluable immunogenicity result at all of days 4, 8 & 31 (follow-on subjects)or at all of days 34, 38 & 61(naive)|||Percentage of subjects||95% Confidence Interval|Number
2576884|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:8 After Booster Dose/Second Vaccination of rMenB+OMV NZ|"Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points:~Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose."|Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose.|Analysis was performed on PPS kinetics which included all subjects who had no protocol deviations/any other reason defined prior to analysis, leading to exclusion & correctly received the vaccination at day 1/day 31 & day 1 & provided evaluable immunogenicity result at all of days 4, 8 & 31 (follow-on subjects)or at all of days 34, 38 & 61(naive)|||Percentage of subjects||95% Confidence Interval|Number
2576991|NCT02445911|Primary|Difference in the Change From Baseline in Fasting Blood Glucose Between KQ-791 and Placebo|Data table is change from baseline in Fasting Blood Glucose. Statistical Analysis includes results for difference in Change from baseline in Fasting Blood Glucose Between KQ-791 and Placebo.|Baseline to Day 29|Pharmacodynamic (PD) population incudes all 81 participants|||mg/dL milligrams per deciliters||Standard Deviation|Mean
2576885|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:5 After Booster Dose/Second Vaccination of rMenB+OMV NZ|"Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points:~Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose. This outcome measure was assessed only for strains H44/76 and M10713."|"Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose."|Analysis was performed on the PPS kinetics which included all subjects who correctly received the vaccination at day 1/ day 1 & day 31 (naive subjects) & provided evaluable immunogenicity result at all of days 4, 8 & 31 (for follow-on subjects) or at all of days 34,38 & 61 (naive subjects).|||Percentage of subjects||95% Confidence Interval|Number
2576886|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:4 After Booster Dose/Second Vaccination of rMenB+OMV NZ|"Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. On day 1, subjects in the Group B_0_1 were to be randomized into 2 different blood draw schedules according to a 1:1 ratio : 2 blood samples at different time points:~Group B_0_1_1: blood draws at 3 and 30 days after the second dose. Group B_0_1_2: blood draws at 7 and 30 days after the second dose.~This outcome measure was assessed only for strains 5/99 and NZ98/254."|Group 3B: 3, 7 and 30 days after third dose booster; Group B_0_1: At 3 (group B_0_1_1 only), 7 (sub-group B_0_1_2 only) and 30 days post-second dose.|Analysis was performed on PPS kinetics which included all subjects who correctly received the vaccination at day 1/ day 1 & day 31 (naive subjects) & provided evaluable immunogenicity result at all of days 4, 8 & 31 (for follow-on subjects) or at all of days 34,38 and 61 (naive subjects).|||Percentage of subjects||95% Confidence Interval|Number
2576887|NCT02446743|Secondary|Percentages of Subjects With at Least 4-fold Increase in hSBA Titers Pre Vaccination Compared to One Month Post-booster/First rMenB+OMV NZ Vaccination|The percentage of subjects with 4-fold rise at one month post-vaccination with a booster dose (follow-on subjects) /first dose (naive subjects) of rMenB+OMV NZ with respect to day 1 (follow-on subjects) / pre-first dose of rMenB+OMV NZ (naïve subjects). Percentage of subjects with four-fold rise in hSBA titers relative to baseline were defined as: • for a pre-vaccination titer < 4, a post-vaccination titer of at least 16; • for a pre-vaccination titer ≥ 4 but <LLOQ, a post vaccination titer of at least fourfold the LLOQ; • for a pre-vaccination titer ≥LLOQ, a post vaccination titer of at least fourfold the pre-vaccination titer|Group 3B: 1 month after booster dose; Group B_0_1: 1 month after first vaccination|Analysis was performed on the Full Analysis set (FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for atleast one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
2576888|NCT02446743|Secondary|Geometric Mean Ratio (GMRs) of GMTs After Booster Dose/First rMenB+OMV NZ Vaccination Versus Day 1.|Bactericidal activity was measured against each of the fout N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713 by calculating the GMRs of GMTs one month post-vaccination of a booster dose versus pre-booster dose (follow-on subjects) or first dose of rMenB+OMV NZ versus prefirst dose (naïve subjects) to each N. meningitidis group B indicator strain.|At Day 31 (30 days post booster dose/first dose of vaccination) versus Day 1 (prior to booster dose/first dose of vaccination).|Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain.|||Ratio||95% Confidence Interval|Geometric Mean
2576889|NCT02446743|Secondary|hSBA Geometric Mean Titers Prior to Booster/First Dose of Vaccination & Post Booster/First Dose of Vaccination.|Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76, 5/99,NZ98/254 and M10713.|Group 3B subjects: Day 1(pre-booster dose) and 30 days post-booster dose. Group B_0_1: Day 1 (pre-first dose) and 30 days post-first dose.|Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain.|||Titers||95% Confidence Interval|Geometric Mean
2576890|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:16 After Booster Dose/First Vaccination of rMenB+OMV NZ|Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76, 5/99, NZ98/254 & M10713.|Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.|Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
2576891|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:8 After Booster Dose/First Vaccination of rMenB+OMV NZ|Bactericidal activity was measured against each of the four N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713.|Group 3B : 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.|Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
2576892|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:5 After Booster Dose/First Vaccination of rMenB+OMV NZ.|Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713. This outcome measure was assessed only for strains H44/76 and M10713.|Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.|Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
2576992|NCT02445859|Primary|Number of Patients With a Surgical Site Infection|Superficial and deep surgical site infections as defined by the CDC (Centre's for Disease Control) definitions of surgical site infections.|Number of patients with a surgical site infection within 30 days of a colorectal surgical procedure.||||Participants|||Count of Participants
2576893|NCT02446743|Secondary|Percentage of Subjects With hSBA ≥1:4 After Booster Dose/First Vaccination of rMenB+OMV NZ.|Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. This outcome measure was assessed only for strains 5/99 and NZ98/254.|Group 3B: 30 days after booster dose, Group B_0_1 : 30 days after first vaccination.|Analysis was performed on the Full Analysis set( FAS) booster. The FAS booster included all follow on subjects and all naive subjects in the All enrolled set who received vaccination at day 1 and provided evaluable immunogenicity result at day 31 for at least one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
2576894|NCT02446743|Primary|Number of Subjects With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs.|A serious adverse event is any untoward medical occurrence that at any dose results in death or is life threatening or requires prolonged hospitalization, leads to Persistent or significant disability/incapacity.|Group 3B: from Day 1 to Day 31 (study termination visit) and Group B_0_1: from Day 1 to Day 61 (study termination visit)|Analysis was performed on the Overall safety set. The overall safety set included all screened subjects in the solicited and unsolicited safety set who provided informed consent and provided demographic and/or baseline screening assessments, regardless of the subject’s randomization and treatment status in the study and received a Subject ID.|||Subjects|||Number
2576895|NCT02446743|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited adverse event is an adverse event that was not solicited using a subject Diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent. Note : Vaccination 2 was performed only on group B_0_1 subjects.|30 days (including the day of vaccination) after each vaccination.|Analysis was performed on the unsolicited safety set. The unsolicited safety set included all subjects who received a study vaccination with unsolicited adverse event data.|||Subjects|||Number
2576896|NCT02446743|Primary|Number of Subjects With Solicited Local and Systemic AEs.|Solicited adverse events are signs and symptoms derived from organized data collection systems, such as Subject Diaries or interview. The percentage and frequencies of subjects reporting solicited local and systemic AEs were tabulated. Threshold for any Erythema, Swelling and Induration: >= 25 mm Note:Vaccination 2 was performed only on group B_0_1 subjects. Threshold for any Erythema, Swelling and Induration: >= 25 mm|7 days (including the day of vaccination) after each vaccination|The analysis was done on the Solicited Safety Set. The solicited safety set included all subjects in the exposed set with any solicited adverse event data and/indicators of solicited adverse events.|||Subjects|||Number
2576897|NCT02446743|Primary|Geometric Mean Ratios (GMRs) of GMTs After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study Versus Day 1.|The GMRs of GMTs at Day 1 versus one month after the last dose of rMenB+OMV NZ vaccination in the parent study were calculated. Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76, 5/99,NZ98/254 and M10713.|Group 3B: 1 month after the last vaccination in parent study and Day 1 (prior to booster dose)|Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (B_0_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.|||Ratio||95% Confidence Interval|Geometric Mean
2576898|NCT02446743|Primary|hSBA Geometric Mean Titers (GMTs) After the Last Dose of rMenB+OMV NZ Vaccination in the Parent Study.|Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76,5/99, NZ98/254 a nd M10713.|Group 3B: 1 month after the last rMenB+OMV NZ vaccination in parent study and Day 1(prior to booster dose); Group B_0_1: Day 1(prior to first dose)|Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (group B_0_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.|||Titers||95% Confidence Interval|Geometric Mean
2576899|NCT02446743|Primary|Percentage of Subjects With hSBA≥1:16|Bactericidal activity was measured against each of the N. meningitidis group B Indicator strains H44/76,5/99,NZ98/254 and M10713|Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).|Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
2576900|NCT02446743|Primary|Percentage of Subjects With hSBA≥1:8|Bactericidal activity was measured against each of the N. meningitidis group B indicator strains H44/76,5/99,NZ98/254 and M10713|Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).|Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (group B_0_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
2576901|NCT02446743|Primary|Percentage of Subjects With hSBA Titers≥1:5 in Parent Studies-V72P10 and V72_41|Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713|At one month after last vaccination in parent studies- V72P10 (Month 7) and V72_41 (Month 2)|Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (group B_0_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
2576902|NCT02446743|Primary|Percentage of Subjects With hSBA≥1:5|Bactericidal activity was measured against the N. meningitidis group B indicator strains H44/76 and M10713. This outcome measure was assessed only for strains H44/76 and M10713.|Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).|Analysis was performed on the Full analysis set (FAS) persistence.The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set, and all naïve subjects (group B_0_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1, for at least one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
2576953|NCT02446223|Primary|Change in Lesion Count From Baseline to Day 59|The primary efficacy endpoint will be complete clearance of all clinically visible AKs and no development of any new AKs on day 59. Lesion clearance will be determined on day 59 (visit 7) by comparing pretreatment lesion count with current lesion count on day 59, with primary efficacy endpoint being clearance of all lesions in treatment field and no growth of new lesions.|Day 59||||Leasion Count||Standard Deviation|Mean
2576903|NCT02446743|Primary|Percentage of Subjects With Human Serum Bactericidal Activity (hSBA)≥1:4|Bactericidal activity was measured against the N. meningitidis group B indicator strains 5/99 and NZ98/254. This outcome measure was assessed only for strains 5/99 and NZ98/254.|Group 3B: Day 1 (prior to booster dose); Group B_0_1: Day 1 (prior to first dose).|Analysis was performed on the Full analysis set (FAS) persistence. The FAS included all follow-on subjects (Group 3B) in the All Enrolled Set,& all naïve subjects (group B_0_1) in the All Enrolled Set who provided evaluable immunogenicity result at day 1,for at least one indicator strain.|||Percentage of subjects||95% Confidence Interval|Number
2576904|NCT02446717|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
2576905|NCT02446717|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Day 3, Treatment Weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment for 12-week treatment arms), and 16 (end of treatment for 16-week treatment arm) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population)|||percentage of participants||95% Confidence Interval|Number
2576906|NCT02446717|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)|SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.|4 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2576907|NCT02446717|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|Intent-to-treat population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2576908|NCT02446691|Secondary|rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age.|To assess antibody response in terms of GMTs using rSBA assay against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.|At 13 months of age (Visit 5)|The Analysis was done on FAS rSBA 1 month, which included all enrolled subjects who received atleast one study vaccination and provided evaluable rSBA immunogenicity data at 1 month after last vaccination for atleast one serogroup.|||Titers||95% Confidence Interval|Geometric Mean
2576909|NCT02446691|Secondary|hSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age|To assess antibody response in terms of GMTs using hSBA assay against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.|At 13 months of age (Visit 5)|The Analysis was done on FAS hSBA 1 month, which included all enrolled subjects who received atleast one study vaccination and provided evaluable hSBA immunogenicity data at 1 month after last vaccination for atleast one serogroup.|||Titers||95% Confidence Interval|Geometric Mean
2576910|NCT02446691|Secondary|rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age|To assess persistence of antibody response in terms of GMTs using rSBA assay against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.|At 24 months of age (Visit 6)|Analysis was performed on the Full analysis set (FAS), which included all enrolled subjects who received atleast one study vaccination and provided an evaluable rSBA Visit 6 assessment, one year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age ), for atleast one serogroup.|||Titers||95% Confidence Interval|Geometric Mean
2576911|NCT02446691|Secondary|hSBA Geometric Mean Titers (GMTs) Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age|To assess persistence of antibody response in terms of GMTs using hSBA assay against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.|At 24 months of age (Visit 6)|Analysis was performed on the Full analysis set (FAS), which included all enrolled subjects who received atleast one study vaccination and provided an evaluable hSBA Visit 6 assessment, one year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age ), for atleast one serogroup.|||Titers||95% Confidence Interval|Geometric Mean
2576912|NCT02446691|Secondary|Percentage of Subjects With rSBA Titers ≥ 128 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age|To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement.|At 13 months of age (Visit 5)|The Analysis was done on FAS rSBA 1 month, which included all enrolled subjects who received atleast one study vaccination and who provided evaluable rSBA immunogenicity data at 1 month after last vaccination for atleast one serogroup.|||Percentage of subjects||95% Confidence Interval|Number
2576913|NCT02446691|Secondary|Percentage of Subjects With rSBA Titers ≥ 8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age|To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement.|At 13 months of age (Visit 5)|The Analysis was done on FAS rSBA 1 month, which included all enrolled subjects who received atleast one study vaccination and who provided evaluable rSBA immunogenicity data at 1 month after last vaccination for atleast one serogroup.|||Percentage of subjects||95% Confidence Interval|Number
2576914|NCT02446691|Secondary|Percentage of Subjects With hSBA ≥8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age|To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using human serum complement.|At 13 months of age (Visit 5)|The Analysis was done on FAS hSBA 1 month, which included all enrolled subjects who received at least one study vaccination and who provided evaluable hSBA immunogenicity data at 1 month after last vaccination for at least one serogroup.|||Percentage of subjects||95% Confidence Interval|Number
2576915|NCT02446691|Primary|Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 128 Against Each N.Meningitidis Serogroup at 24 Months of Age|To assess antibody persistence against N. Meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement|At 24 months of age (Visit 6)|Analysis was performed on the FAS, which included all enrolled subjects who receive at least one study vaccination and provided an evaluable rSBA Visit 6 assessment, one year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age), for at least one serogroup.|||Percentage of subjects||95% Confidence Interval|Number
2576916|NCT02446691|Primary|Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 8, Against Each N.Meningitidis Serogroup at 24 Months of Age|To assess antibody persistence against N. Meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement|At 24 months of age (Visit 6)|Analysis was performed on the FAS, which included all enrolled subjects who receive at least one study vaccination and provided an evaluable rSBA Visit 6 assessment, one year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age), for at least one serogroup.|||Percentage of subjects||95% Confidence Interval|Number
2576917|NCT02446691|Primary|Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 8 Against Each N.Meningitidis Serogroup A,C,W and Y at 24 Months of Age.|To assess antibody persistence against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using human serum complement.|At 24 months of age (Visit 6)|Analysis was performed on the Full analysis set (FAS), which included all enrolled subjects who received at least one study vaccination and provided an evaluable hSBA Visit 6 assessment, one year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age), for at least one serogroup.|||Percentage of subjects||95% Confidence Interval|Number
2576918|NCT02446691|Primary|Number of Subjects With Serious AEs (SAEs)|Subjects reporting SAEs from day 1 to visit 6 (at 24 months of age) were assessed. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in one or more of the following: death, is life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.|From Day 1 to Visit 6 (At 24 months of age)|Analysis was performed on the overall safety set, which included all subjects who received a study vaccination and reported any solicited/unsolicited adverse event data.|||Participants|||Count of Participants
2576919|NCT02446691|Primary|Number of Subjects With Any Medically Attended Unsolicited AEs and AEs Leading to Premature Withdrawal|An unsolicited adverse event is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject parent(s)/legal guardian(s)] who has signed the informed consent. All medically attended unsolicited AEs were collected from Day 1 to Visit 6.|From Day 1 to Visit 6 (at 24 Months of age)|Analysis was performed on the unsolicited safety set, which included all subjects who received a study vaccination and reported any unsolicited adverse event data.|||Participants|||Count of Participants
2576920|NCT02446691|Primary|Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination.|Solicited systemic AEs reported from day 1 to day 7 after each vaccination were assessed. Assessed systemic symptoms include change in eating habits, sleepiness, irritability, vomiting, diarrhea and fever (body temperature ≥ 38°C (100.4°F)).|From Day 1 to Day 7 after each vaccination|Analysis was performed on the solicited safety set, which included all subjects who received a study vaccination and reported any solicited adverse event data and/or indicators of solicited adverse events.|||Participants|||Count of Participants
2576921|NCT02446691|Primary|Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination|Solicited local AEs reported from day 1 to day 7 after each vaccination were assessed. Assessed local symptoms include injection site erythema, injection site induration and injection site tenderness. Any = incidence of a particular symptom regardless of intensity grade.Threshold for Erythema and Induration: Type II None (<10 mm), Any (>=10 mm)|From Day 1 to Day 7 after each vaccination|Analysis was performed on the solicited safety set, which included all subjects who received a study vaccination and reported any solicited adverse event data and/or indicators of solicited adverse events.|||Participants|||Count of Participants
2576922|NCT02446691|Primary|Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination.|Solicited signs and symptoms occurring within 30 minutes following each vaccination, include solicited local events (e.g. injection site erythema, induration and tenderness -threshold for Erythema and Induration: Type II- None [<10mm], Any[>=10 mm]), solicited systemic events (e.g. change in eating habits, sleepiness, irritability, vomiting, diarrhea, fever[ body temperature >=38°C measured preferably via tympanic route]), and any other solicited event like use of analgesic/antipyretics for treatment or for prophylaxis|Within 30 minutes of each vaccination|Analysis was performed on the solicited safety set, which included all subjects who received a study vaccination and reported any solicited adverse event data and/or indicators of solicited adverse events.|||Participants|||Count of Participants
2576993|NCT02445807|Secondary|The Percentage of Subjects With Treatment Success at the Day 8 Visit.|"The percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at Day 8.~The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets."|At Day 8 Visit||||percentage of participants|||Number
2576923|NCT02446613|Secondary|Mean Change From Baseline in Individual Nasal Sym. Including Sneezing, Nasal Congestion, Rhinorrhoea and Nasal Itch.|Four individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing were recorded at Baseline (pre-NAC) and at post-NAC 15, 30 min, 1, 2, 3, 4, 5, 6h. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The baseline value were the latest pre-dose assessments. Mean change from Baseline at 15 min, WM0-1h, WM 0-6h, and maximum change over 0-6 h were reported. Change from Baseline was measured as the value recorded at a specified time point minus Baseline value.|Day 1 (Baseline [pre-NAC] to post-NAC 6 h)|Safety population|||Score on a scale||Standard Deviation|Mean
2576924|NCT02446613|Primary|Maximum Percent Change From Baseline in PINF Over Post-NAC 6 h|PNIF data recorded at Baseline pre-challenge and at 15, 30 min, 1, 2, 3, 4, 5, 6h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). Maximum change from Baseline till 6h was reported.|Day 1 (Baseline [pre-NAC] to post-NAC 6 h)|Safety population|||Percent change||95% Confidence Interval|Median
2576925|NCT02446613|Primary|Percent Change From Baseline in the PNIF up to Post-NAC 6 h|PNIF data recorded at Baseline pre-challenge and at 15, 30 min, 1, 2, 3, 4, 5, 6h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-6h of 15, 30 min, 1, 2, 3, 4, 5, 6h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.|Day 1 (Baseline [pre-NAC] to post-NAC 6 h)|Safety populaton|||Percent change||95% Confidence Interval|Median
2576926|NCT02446613|Primary|Percent Change From Baseline in the PNIF Over Post-NAC 1 h|PNIF data recorded at Baseline pre-challenge and at 15, 30 min and 1h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-1 h of 15, 30 min and 1 h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.|Day 1 (Baseline [pre-NAC] to post-NAC 1 h)|Safety population|||Percent change||95% Confidence Interval|Median
2576927|NCT02446613|Primary|Percent Change From Baseline in the Peak Nasal Inspiratory Flow (PNIF) at Post-NAC 15 Min|PNIF data recorded at Baseline pre-challenge and at 15, 30 min and 1h. The percent change from Baseline and at specified time point was derived by the formula (PNIF at Baseline minus PNIF at Post-NAC specified time point) divided by PNIF at Baseline) multiplied by 100. The baseline values were the latest pre-dose assessments. The baseline value were the latest pre-dose assessments. Percent change in PNIF were reported as median (credible interval). WM 0-1 h of 15, 30 min and 1 h was reported. WM were derived by first calculating the AUC using the trapezoidal rule, and then dividing by the time interval. If available, actual times were used in the calculation, otherwise planned relative times were used for the calculation.|Day 1 (Baseline [pre-NAC] and post-NAC 15 min)|Safety population|||Percent change||95% Confidence Interval|Median
2576928|NCT02446613|Primary|Maximum (Max) Mean Change From Baseline (BL) in the TNSS Over Post-NAC 6 h|TNSS was obtained from 4 individual nasal sym.: nasal congestion, rhinorrhoea, nasal itch and sneezing. Par rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym. scores were combined to produce a TNSS. TNSS were reported as median (credible interval). BL values were the latest pre-dose assessments. Change from BL was measured as the value recorded at a specified time point minus BL value. The max change from BL from the set of individual PNIF % reduction measurements made over the 0 to 6 h sampling period.|Day 1 (Baseline [pre-NAC] to post-NAC 6 h)|Safety population|||Score on a scale||95% Confidence Interval|Median
2576929|NCT02446613|Primary|Mean Change From Baseline in the TNSS Over Post-NAC 6 h|TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as value recorded at a specified time point minus Baseline value. WM 0-6 h of 15, 30 min, 1, 2, 3, 4, 5, 6h was reported.|Day 1 (Baseline [pre-NAC] to post-NAC 6 h)|Safety population|||Score on a scale||95% Confidence Interval|Median
2576950|NCT02446314|Primary|Combined Z Score of Delayed Words Recalled, Words Recognised, and Pictures Recognised.|Combined Z score of proportion of words recalled, proportion of words recognised, and proportion of pictures recognised. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. A negative change value reflects a decrease in memory or a worse outcome and a positive change value reflects an increase in memory or a better outcome|12, and 24 weeks||||z-score||Standard Error|Mean
2585966|NCT02339558|Other Pre-specified|Functional MRI Parameters|Graphical methods and descriptive statistics will be used.|Up to 16 weeks|||||||
2576930|NCT02446613|Primary|Mean Change From Baseline in the TNSS Over Post-NAC 1 h|TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as the value recorded at a specified time point minus Baseline value. Weighted mean (WM) 0-1h of 15, 30 min and 1 h was reported.|Day 1 (Baseline [pre-NAC], 15 to post-NAC 1h)|Safety population|||Score on a scale||95% Confidence Interval|Median
2576931|NCT02446613|Primary|Mean Change From Baseline in the Total Nasal Sym. Score (TNSS) at Post-NAC 15 Minutes (Min)|TNSS was obtained from 4 individual nasal sym. including nasal congestion, rhinorrhoea, nasal itch and sneezing. Participants rated sym. on a 4-point scale. For nasal blockage and congestion the scores were (0= Breathing through nose freely and easily, 1= Slight difficulty breathing through nose, 2= Moderate difficulty breathing through nose and 3= Severe difficulty breathing through nose). For rhinorrhoea, nasal itching and sneezing (0= None: No sym. whatsoever; Absent, 1= Mild: Sym. is present, noticeable but not bothersome, 2= Moderate: Sym. is bothersome, but tolerable and 3= Severe: Sym. which are bothersome, harder to tolerate). The individual sym. scores were combined to produce a TNSS. TNSS were reported as median (credible interval). The baseline values were the latest pre-dose assessments. Change from baseline was measured as the value recorded at 15 min post-NAC minus Baseline value.|Day 1 (Baseline [pre-NAC] and post-NAC 15 min)|The Safety population consisted of members of the ASP of parent study TL7116958 who had passed screening for study 204509.|||Score on a scale||95% Confidence Interval|Median
2576932|NCT02446496|Secondary|Apparent First-order Elimination or Terminal Rate Constant (Ke)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. Apparent first-order elimination or terminal rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.|Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.|All subject population. All participants were present at the time of measurement.|||Per hour||Standard Deviation|Mean
2576933|NCT02446496|Secondary|Time of the Maximum Plasma Concentration (T-max) and Terminal Half- Life (T-half)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. If the maximum value occurs at more than one point T-max was defined as the first time point with this value. The elimination or terminal half-life was calculated by dividing 0.693 (natural logarithm of 2) with lambda z, where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data after each single dose.|Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.|All subject population. All participants were present at the time of measurement.|||Hour||Full Range|Median
2576934|NCT02446496|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) and Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-infinity)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. Area under the plasma concentration-time curve from time zero (0) to the last measurable concentration (t), as calculated by the linear trapezoidal method. Area under the plasma concentration-time curve from time zero (0) to infinity (AUC0-infinity) was calculated as the sum of the AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant (Ke), where first-order elimination or terminal rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.|Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.|All subject population. All participants were present at the time of measurement.|||Microgram.hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2576935|NCT02446496|Primary|Maximal Measured Plasma Concentration (Cmax) After a Single Dose|Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified.|Pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00, 4.00, 6.00, 8.00, 10.00 and 12.00 hours post-dose in each treatment period.|All subject population: who were crossed over and completed the balance design, were included in the calculation. All participants were present at the time of measurement.|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2576936|NCT02446483|Secondary|Apparent First-order Elimination or Terminal Rate Constant|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. Apparent first-order elimination or terminal rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.|Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 4.33, 4.66, 5.00, 5.33, 5.66, 6.00, 8.00, 12.00 and 14.00 h post-dose in each treatment period|All subject population. Data is presented for the participants available at the time of assessment.|||Per hour||Geometric Coefficient of Variation|Geometric Mean
2576937|NCT02446483|Secondary|Time of the Maximum Plasma Concentration (T-max) and Terminal Half-life (T-half)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. If the maximum value occurs at more than one point T-max was defined as the first time point with this value. The elimination or terminal half-life was calculated by dividing 0.693 (natural logarithm of 2) with b obtained as the slope of the linear regression of the logarithmically transformed plasma concentrations versus time in the terminal period of the plasma curve.|Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 4.33, 4.66, 5.00, 5.33, 5.66, 6.00, 8.00, 12.00 and 14.00 h post-dose in each treatment period.|All Subject Population. Only those participants available at the specified time points were analyzed.|||h||Full Range|Median
2576938|NCT02446483|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) and Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-infinity)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. AUC0-t was calculated by the linear trapezoidal method. AUC0-infinity was calculated as the sum of the AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant, where first-order elimination or terminal rate constant was calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations. Values were reported as Least Squares Geometric Means with respective % CV.|Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 4.33, 4.66, 5.00, 5.33, 5.66, 6.00, 8.00, 12.00 and 14.00 h post-dose in each treatment period.|All subject population. Only those participants available at the specified time points were analyzed.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2576939|NCT02446483|Primary|Mean Maximal Measured Plasma Concentration (Cmax) After a Single Dose|Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified. Values were reported as Least Squares Geometric Means with respective Geometric Coefficient of Variation (% CV).|Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 4.33, 4.66, 5.00, 5.33, 5.66, 6.00, 8.00, 12.00 and 14.00 h post-dose in each treatment period.|All subject population comprised of all participants who were crossed over and completed the balance design, were included in the calculation.|||Nanogram per mL (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2576940|NCT02446418|Secondary|Percentage of Participants With Correct Use of Device, Defined as Not Making Any Critical or Non-critical Errors, at Week 12, and at Week 24 Independently of the Use at Week 12|Participants were asked to read the appropriate package insert for their prescribed inhaler and then the investigator (or suitably qualified designee) demonstrated the proper use of the inhaler. The participant was then asked to self-administer their first dose of study treatment under the supervision of the investigator and any critical and non-critical errors were recorded. Individual instruments for assessing correct inhaler use were provided for each of the three devices used in this study.|Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
2576941|NCT02446418|Secondary|Change From Baseline in ACT Total Score at Week 24|The ACT is a validated self-completed questionnaire consisting of 5 questions that evaluate asthma control on a 5-point categorical scale. Total scores are calculated from the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline value was the last assessment prior to randomization (Day 0). Change from Baseline was post-dose visit value minus the Baseline value. Least square mean change is presented.|Baseline and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2576942|NCT02446418|Primary|Change From Baseline in Asthma Control Test (ACT) Total Score at Week 12|The ACT is a validated self-completed questionnaire consisting of 5 questions that evaluate asthma control during the past 4 weeks on a 5-point categorical scale. Total scores are calculated from the sum of the scores from the 5 questions and can range from 5 to 25, with higher scores indicating better control. An ACT total score of 5 to 19 suggests that the participant's asthma is unlikely to be well controlled, whilst a score of 20 to 25 suggests that the participant's asthma is likely to be well controlled. Baseline value was the last assessment prior to randomization (Day 0). Change from Baseline was post-dose visit value minus the Baseline value. Least square mean change is presented.|Baseline and Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Error|Least Squares Mean
2576943|NCT02446314|Secondary|Negative Affect Score|As measured by the negative mood scale derived from the Positive and Negative Affect Schedule. This measure consists of 10 words relating to negative affect. The participants is asked to rate how they feel about each word from 1 (very slightly/not at all) to 5 (extremely) with a minimum score of 5 and maximum of 50. A higher score relates to higher negative affect.|12, and 24 weeks.||||units on a scale||Standard Error|Mean
2576944|NCT02446314|Secondary|Positive Affect Score|As measured by the positive mood scale derived from the Positive and Negative Affect Schedule. This measure consists of 10 words relating to positive affect. The participants is asked to rate how they feel about each word from 1 (very slightly/not at all) to 5 (extremely) with a minimum score of 5 and maximum of 50. A higher score relates to higher positive affect.|12, and 24 weeks||||units on a scale||Standard Error|Mean
2576945|NCT02446314|Secondary|Heart Rate|LMM analysis of intervention group x 12 and 24 wk test session. Baseline heart rate entered as a covariate.|12, and 24 weeks.||||beats/min||Standard Error|Mean
2576946|NCT02446314|Secondary|Diastolic Blood Pressure|LMM analysis of intervention group x 12 and 24 wk test session. Baseline blood pressure entered as a covariate.|12, and 24 weeks||||mmHg||Standard Error|Mean
2576947|NCT02446314|Secondary|Systolic Blood Pressure|LMM analysis of intervention group x 12 and 24 wk test session. Baseline blood pressure entered as a covariate.|12, and 24 weeks.||||mmHg||Standard Error|Mean
2576948|NCT02446314|Secondary|Combined Z Score of Proportion of Immediate Words Recalled, Number of Correct Serial 3 and Serial 7 Subtractions, Sternberg Task Coefficent of the Line|Combined Z Score of Proportion of Immediate Words Recalled, Number of Correct Serial 3 and Serial 7 Subtractions, and the Coefficient of the Line for Reaction Time by Length of Sting During Probe Recall. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. A negative change value reflects a decrease in memory or a worse outcome and a positive change value reflects an increase in memory or a better outcome|12, and 24 weeks||||z-score||Standard Error|Mean
2576951|NCT02446314|Primary|Total Number of Correct Sequences Recalled|Participants view an array of 9 white squares on a monitor which light up red in sequences of between 2 and 9. They are then required to press the correct squares in the sequence they were presented.|12, and 24 weeks||||Correct number of sequences||Standard Error|Mean
2576954|NCT02446171|Secondary|Taste Test Assessment.|"A standardized questionnaire was provided to participants and were asked to complete the questionnaire for the liquid formulations tested, i.e., Naloxegol crushed tablet, oral (Treatment A) and Naloxegol oral solution (Treatment C), without assistance or influence from site personnel. For each formulation, the questionnaire was identical and required the participant's opinion. Sweet, salty, sour, bitter, metallic, hot/spicy were rated on a scale of 0 to 10, where 0 means not at all and 10 means extreme. The overall rating of the taste was rated on a scale of 0 to 10, where 0 means I dislike it extremely much and 10 means I like it extremely much. The smell of the medicine was based on a scale of 0 to 10, where 0 means extremely bad and 10 means extremely nice. The question on whether the participants would consider ever taking the medicine again was based on a scale of 0 to 10, where 0 means Never - under no circumstances and 10 means Yes, definitely."|Within 1 hour after dosing (Treatments A and C only).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.|||units on a scale||Full Range|Median
2576955|NCT02446171|Secondary|Participants With Significant Findings in Hematology, Clinical Chemistry and Urinalysis.|Participants were assessed through each laboratory variables for any significant abnormalities. Hematology assessments included white blood cell count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin and others. Clinical chemistry assessment included testing levels of sodium, potassium, urea, creatinine, albumin, calcium, glucose (fasting) and others. Urinalysis assessment included glucose, protein, blood and microscopy (if positive for blood or protein).|At screening and at the final follow-up visit (maximum 9 weeks apart); in addition, for the first and third treatment period at pre-dose.|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.|||participants|||Number
2576956|NCT02446171|Secondary|Participants With Significant Findings in 12-Lead Electrocardiography (ECG).|A 12-lead ECG was obtained after the participant rested in supine position for at least 10 minutes. The study physician was to judge the overall interpretation as normal or abnormal. If abnormal, it was decided as to whether or not the abnormality was clinically significant and the reason for the abnormality was recorded.|At screening, first admission to the clinical unit (Visit 2, Day -1), 1.25 hours after each dose (Visits 2-5, Day 1), as well as at the final follow-up visit (up to 9 weeks).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.|||participants|||Number
2576957|NCT02446171|Secondary|Participants With Significant Findings in Columbia-Suicide Severity Rating Scale (C-SSRS).|The C-SSRS is a unique, simple and short method of assessing both behavior and ideation that tracks all suicidal events, and provided a summary of suicidality. It assesses the lethality of attempts and other features of ideation (frequency, duration, controllability, reasons for ideation and deterrents), all of which are significantly predictive of completed suicide. The C-SSRS was performed to determine the presence of suicidality.|At Baseline and Days 1-4 of each treatment period.|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.|||participants|||Number
2576958|NCT02446171|Secondary|Participants With Significant Findings in Physical Examination.|A complete physical examination included an assessment of the general appearance, respiratory, cardiovascular, abdomen, skin, head, and neck (including ears, eyes, nose, mouth and throat), lymph nodes, thyroid, musculoskeletal and neurological systems. Physical examination was performed to check for any significant abnormality in participants.|A full physical examination at screening and the final follow-up visit (maximum 9 weeks apart). Abbreviated physical examination on admission (on Day -1 of each treatment period) and at 48-hours post-dose to each treatment period (for up to 4 weeks).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.|||participants|||Number
2576959|NCT02446171|Secondary|Mean Change From Baseline for Vital Signs in Supine Pulse Rate.|Pulse rate: the measurement of vital signs for pulse rate is presented in the below outcome table.|Day 2 (24h post-dose), Day 3 (48h post-dose) and Day 4 (72h post-dose).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.|||beats per minute (bpm)||Standard Deviation|Mean
2576960|NCT02446171|Secondary|Mean Change From Baseline for Vital Signs of Supine Systolic and Diastolic Blood Pressure.|The following variables were collected after the participants had rested in the supine position for at least 5 minutes: Systolic Blood Pressure (SBP) and Diastolic BP. The measurement of vital signs for SBP and DBP are presented in the below outcome table.|Day 2 (24h post-dose), Day 3 (48h post-dose) and Day 4 (72h post-dose).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.|||mmHg||Standard Deviation|Mean
2576961|NCT02446171|Secondary|Percentage of Participants With Adverse Events (AE).|An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.The term AE is used generally to include any AE whether serious or non-serious. An serious AE (SAE) is an AE that fulfills one or more of the following criteria: results in death, is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.|For up to 9 weeks (starting with screening).|The safety analysis set included all participants who had received at least one dose of Naloxegol and for whom any safety post-dose data were available.|||percentage of participants|||Number
2576962|NCT02446171|Secondary|Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F).|This was one of the PK parameters to determine the apparent volume of distribution during the terminal phase after extravascular administration.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.|||L||Geometric Coefficient of Variation|Geometric Mean
2576963|NCT02446171|Secondary|Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (CL/F).|This was one of the PK parameters to determine the apparent total body clearance after extravascular administration estimated as dose divided by AUC. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2576964|NCT02446171|Secondary|Mean Residence Time (MRT).|This was one of the PK parameters to determine MRT. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.|||h||Standard Deviation|Mean
2576965|NCT02446171|Secondary|Mean Dissolution Time (MDT).|This was one of the PK parameters to determine MDT (whole tablet only) (calculated as MRT Treatment D [Reference] - MRT Treatment C [Test]). Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point. There were zero participants analyzed in Treatment A, B and C, hence data was not determined.|||h||Standard Deviation|Mean
2576966|NCT02446171|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz).|This was one of the PK parameters to determine λz of a t½λz. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.|||h||Standard Deviation|Mean
2576967|NCT02446171|Secondary|Time to Reach Maximum Plasma Concentration (Tmax).|This was one of the PK parameters to determine the time to reach maximum plasma concentration (tmax). Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.|||h||Full Range|Median
2576968|NCT02446171|Primary|Observed Maximum Plasma Concentration (Cmax).|Observed maximum plasma concentration (Cmax) is presented below. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2576969|NCT02446171|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC 0-t).|Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration is presented below. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to IMP administration]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The PK analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2576970|NCT02446171|Primary|Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-infinity).|Area under plasma concentration-time curve from time zero extrapolated to infinity (AUC) is presented below. Blood was collected pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours post-dose to determine naloxegol plasma concentrations.|Pre-dose (0 hours [within 30 minutes prior to administration of the investigational medicinal product (IMP)]) and post-dose at 0.25 (15 minutes), 0.5 (30 minutes), 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 and 72 hours in each treatment period.|The Pharmacokinetic (PK) analysis set was a subset of those participants in the safety analysis set and included participants who had received at least 1 dose of study medication and had at least 1 post-dose plasma concentration measurement at a scheduled time point.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2576988|NCT02445911|Secondary|Change From Baseline in the Insulin Sensitivity Index (ISI)|Insulin sensitivity index (ISI) composite using Matsuda's whole body insulin sensitivity, ISI [composite] = 10000/√[(FPG x FPI)x(Mean Glucose 0-120min in MMTT x Mean Insulin 0-120 min in MMTT)] where MMTT is a mixed meal tolerance test, Hour 0=just prior dosing. Lower values indicate greater insulin resistance.|Baseline to Day 29|Includes all subjects who receive at least one dose of study drug and have evaluable ISI data.|||units on a scale||Standard Deviation|Mean
2576971|NCT02446015|Secondary|Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28|The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use (Treatment Effectiveness and Treatment Inconvenience). A resultant overall 0-100 treatment satisfaction score was calculated separately for Treatment Effectiveness and Treatment Inconvenience, with higher scores indicating greater satisfaction and less treatment-related bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.|Baseline (Day 0), Day 28|Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with non-missing response.|||units on a scale||Standard Error|Least Squares Mean
2576972|NCT02446015|Secondary|Change From Baseline in Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score at Day 28|The IDEEL SB module is a 20 question patient reported outcome questionnaire that assesses the subject's symptoms of dry eye. An overall resultant calculated score ranges from 0 to 100, with higher scores indicating greater symptom bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.|Baseline (Day 0), Day 28|Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with non-missing response.|||units on a scale||Standard Error|Least Squares Mean
2576973|NCT02446015|Primary|Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28|"The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded three areas of the ocular surface for dryness on a scale from 0 to 5, where 0 is Absent and 5 is Severe. The three scores were summed for a resultant overall 0-15 score. The change from baseline was calculated as the TOSS score at Day 28 minus the TOSS score at baseline. A more negative change value indicates greater efficacy. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses."|Baseline (Day 0), Day 28|Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with non-missing response.|||units on a scale||Standard Error|Least Squares Mean
2576974|NCT02445911|Secondary|Accumulation Index (AI)|Based on AUC (RacAUC), where RacAUC is the ratio of AUC during a dosing interval following the last dose over the loading dose (first dose)|Pre-dose, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose; Day 3, 8, 15, 22, 29, and up to 24 hours post-dose on Day 29|Includes all randomized subjects who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute AI.|||1/h||Standard Deviation|Mean
2576975|NCT02445911|Secondary|Apparent Terminal Elimination Half-life (t1/2)||Pre-dose, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose; Day 3, 8, 15, 22, 29, and up to 24 hours post-dose on Day 29|Includes all randomized subjects who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute t1/2.|||hours||Standard Deviation|Mean
2576976|NCT02445911|Secondary|Time of the Maximum Measured Plasma Concentration at Steady-state (Tmax_ss)||Pre-dose, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose; Day 3, 8, 15, 22, 29, and up to 24 hours post-dose on Day 29|Includes all randomized subjects who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Tmax_ss.|||hours||Standard Deviation|Mean
2576977|NCT02445911|Secondary|Maximum Observed Plasma Concentration at Steady-state (Cmax_ss)||Pre-dose, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose; Day 3, 8, 15, 22, 29, and up to 24 hours post-dose on Day 29|Includes all randomized subjects who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Cmax_ss.|||ng/mL||Standard Deviation|Mean
2576978|NCT02445911|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUCtau)||Pre-dose, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose; Day 3, 8, 15, 22, 29, and up to 24 hours post-dose on Day 29|Includes all randomized subjects who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute AUCtau.|||ng*hr/mL||Standard Deviation|Mean
2576979|NCT02445911|Secondary|Time of the Maximum Measured Plasma Concentration (Tmax)||Pre-dose, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose|Includes all randomized subjects who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Tmax.|||hours||Standard Deviation|Mean
2576980|NCT02445911|Secondary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose|Includes all randomized subjects who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Cmax.|||ng/mL||Standard Deviation|Mean
2576981|NCT02445911|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24-hours Post-Dose (AUC0-24)||Pre-dose, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose|Includes all randomized subjects who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute AUC0-24.|||ng*hr/mL||Standard Deviation|Mean
2576982|NCT02445911|Secondary|Change From Baseline in HbA1c||Baseline to Day 29|Includes all subjects who receive at least one dose of study drug and have evaluable HbA1c data.|||Percentage of glycosylated hemoglobin||Standard Deviation|Mean
2576983|NCT02445911|Secondary|Change From Baseline in Postprandial Glucose||Baseline to Day 29|PD population includes all 81 participants|||hr*mg/dL||Standard Deviation|Mean
2576984|NCT02445911|Secondary|Change From Baseline in 7-point Average Blood Glucose|The 7-points measured were just prior to each meal and 90 minutes after the start of the meal and approximately bedtime.|Baseline to Day 29|PD population includes all 81 participants|||mg/dL||Standard Deviation|Mean
2576985|NCT02445911|Secondary|Change From Baseline in the Hepatic Insulin Resistance Index|Hepatic Insulin Resistance Index will be evaluated as Glucose AUEC from zero to 30 minutes (AUEC0-30min) in MMTT x Insulin AUEC0-30 min in MMTT|Baseline to Day 29|PD population includes all 81 participants|||(hr*mg/dL)*(hr*μUI/mL)||Standard Deviation|Mean
2576986|NCT02445911|Secondary|Change From Baseline in Disposition Index|Disposition Index evaluated as beta index x ISI [composite]. Lower values of the disposition index suggests loss of function of beta cells.|Baseline to Day 29|Includes all subjects who receive at least one dose of study drug and have evaluable data for disposition index.|||Index||Standard Deviation|Mean
2576987|NCT02445911|Secondary|Change From Baseline in Beta Cell Function|Evaluated as beta index = (Insulin Area Under the Effect Curve (AUEC) in MMTT/Glucose AUEC in MMTT)|Baseline to Day 29|PD population includes all 81 participants|||(hr*μIU/mL(hr*mg/dL))||Standard Deviation|Mean
2576989|NCT02445911|Secondary|Change From Baseline in the Quantitative Insulin Sensitivity Check Index (QUICKI)|QUICKI = 1/(log FPG + log FPI) where FPG = fasting plasma glucose (mg/dL); FPI = fasting plasma insulin (estimated based on fasting serum insulin; (μIU/mL)). Lower numbers reflect greater insulin resistance.|Baseline to Day 29|PD population includes all 81 participants|||units on a scale||Standard Deviation|Mean
2576994|NCT02445807|Secondary|The Percent Change in Body Surface Area of Psoriasis|The percent change from baseline in Body Surface Area at Day 15. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.|From Baseline to Day 15||||percentage change in body surface area||Standard Deviation|Mean
2576995|NCT02445807|Primary|Efficacy (Percentage of Subjects With Treatment Success)|"The primary efficacy endpoint is the percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at the Day 15 visit.~The primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets."|Day 15 Visit||||percentage of participants|||Number
2576996|NCT02445755|Primary|In This Study, the Investigators Plan to Test the Performance of a Novel Transcutaneous Device (BiliCareTM) to Screen for Bilirubin Levels at Postnatal Age of 12 to 48 Hours.||12 to 48 hours||||mg/dL||Standard Deviation|Mean
2576997|NCT02445625|Other Pre-specified|Debriefing Interview Questionnaire|Covers: strategies; general experience of the process; adverse effects;|16 weeks|||||||
2576998|NCT02445625|Other Pre-specified|HADS - Hospital Anxiety & Depression Scale|21-item measure of clinical depression|16 weeks|||||||
2576999|NCT02445625|Other Pre-specified|POMS - Profile of Mood States||16 weeks plus 6 months|||||||
2577000|NCT02445625|Secondary|VABS - Vineland Adaptive Behaviour Scale|The Vineland Adaptive Behaviour Scale (VABS) is a semi-structured interview designed to assess global adaptive functioning, composed by 3 main domains: Communication COM, Daily Living Skills DLS and Socialization SOC. The Adaptive Behaviour Composite ABC (total score) is the sum of the raw scores from the main domains. These are transformed in standard scores (m.=100;std.=15). The higher the score, better is the adaptive behavior. Sparrow, S., Balla, D., & Cicchetti, D. (1984). Vineland Adaptative Behaviour Scales: Interview edition, Survey form. Circle Pines, MN: American Guidance Service.|16 weeks, and Follow-Up (6 months after intervention)||||units on a scale||Standard Deviation|Mean
2577001|NCT02445625|Secondary|ATEC - Autism Treatment Evaluation Checklist|"Autism Treatment Evaluation Checklist (ATEC) evaluates the effectiveness of autism treatments - a 1-page form designed to be completed by parents or caretakers. It consists of 4 subtests: I. Speech/Language Communication (14 items, min.0-max.28); II. Sociability (20 items, min.0-max.40); III. Sensory/Cognitive Awareness (18 items, min.0-max.36); and IV. Health/Phys./Behavior (25 items, min.0-max.75). Total score (sum) ranges from min.0-max.179.~The results reported here correspond to the total ATEC score to be used for comparison at a later date. The lower the score, the fewer the problems."|16 weeks, and Follow-Up (6 months after intervention)||||score on a scale||Standard Deviation|Mean
2577002|NCT02445625|Primary|JAAT_Face|Number of fixations on the target object of the joint attention animation of an avatar after the animation starts (e.g. looking at, pointing at) in the Joint-attention assesment task - JAAT_NoFace with previous fixation on avatar face.. We will use a new task/realistic game that will challenge the detection of initiation of joint attention cues (from avatars - gaze or pointing). The number of correct responses (to particular objects and not to non-object parts of the scene) will be recorded. We will also record incorrect responses to non-pointing body gestures.|16 weeks, and 6 months after intervention||||Correct Fixations||Standard Deviation|Mean
2577003|NCT02445625|Primary|JAAT_NoFace|Number of fixations on the target object of the joint attention animation of an avatar after the animation starts (e.g. looking at, pointing at) in the Joint-attention assesment task - JAAT_NoFace with no previous fixation on avatar face.. We will use a new task/realistic game that will challenge the detection of initiation of joint attention cues (from avatars - gaze or pointing). The number of correct responses (to particular objects and not to non-object parts of the scene) will be recorded. We will also record incorrect responses to non-pointing body gestures.|16 weeks, and 6 months after intervention||||Correct Fixations||Standard Deviation|Mean
2577004|NCT02445586|Secondary|Probability of Participants Remaining Alive in Overall Survival From 3 to 34 Months|Overall survival was defined as the time from enrollment to the the date of death from any cause. Participants who were alive at the time of the analysis, dropped out of the study, or lost to follow-up were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication, and participants with no post-baseline information were censored at baseline. Overall survival was analyzed by the Kaplan-Meier method.|Months 3, 9, 13, 14, 15, 18, 19, 20, 24, 25, 27, 32, 33, and 34|ITT Population|||Percent probability of OS|||Number
2577005|NCT02445586|Secondary|Median Duration of Overall Survival|Overall survival was defined as the time from enrollment to the the date of death from any cause. Participants who were alive at the time of the analysis, dropped out of the study, or lost to follow-up were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication, and participants with no post-baseline information were censored at baseline. Overall survival was analyzed by the Kaplan-Meier method.|From Baseline up to death from any cause (up to approximately 3 years)|ITT Population|||months||Inter-Quartile Range|Median
2577006|NCT02445586|Secondary|Number of Participants Who Died or Were Censored for Overall Survival Analysis|Overall survival was defined as the time from enrollment to the the date of death from any cause. Participants who were alive at the time of the analysis, dropped out of the study, or lost to follow-up were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication, and participants with no post-baseline information were censored at baseline. Overall survival was analyzed by the Kaplan-Meier method.|From Baseline up to death from any cause (up to approximately 3 years)|ITT Population|||Participants|||Count of Participants
2577007|NCT02445586|Secondary|Probability of Participants Remaining Event-Free in Progression-Free Survival From 2 to 32 Months|Progression-free survival (PFS) was defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Participants who had not progressed, died or were lost to follow up at the time of the analysis were censored on the last visit at which assessment for progression was done (2 years after the last participant was enrolled). PFS was analyzed by the Kaplan-Meier method.|Months 2, 3, 5, 6, 7, 8, 9, 11, 13, 15, 16, 17, 18, 19, 23, 24, 25, 27, 29, and 32|ITT Population|||Percent probability of PFS|||Number
2577195|NCT02443402|Secondary|Number of Participants With Hypoglycemia After Transition From Intensive Care Unit (ICU)|Number of participants with blood glucose (BG) <70 after transition from ICU.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
2577008|NCT02445586|Secondary|Median Duration of Progression-Free Survival|Progression-free survival (PFS) was defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Participants who had not progressed or died, or were lost to follow up at the time of the analysis, were censored on the last visit at which assessment for progression was done (2 years after the last participant was enrolled). PFS was analyzed by the Kaplan-Meier method.|From Baseline up to disease progression or death (assessed at every 9 weeks, up to approximately 3 years)|ITT Population|||months||95% Confidence Interval|Median
2577009|NCT02445586|Secondary|Number of Participants With Disease Progression or Death or Who Were Censored for Progression-Free Survival Analysis|Progression-free survival (PFS) was defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Participants who had not progressed or died or were lost to follow up at the time of the analysis were censored on the last visit at which assessment for progression was done (2 years after the last participant was enrolled). PFS was analyzed by the Kaplan-Meier method.|From Baseline up to disease progression or death (assessed at every 9 weeks, up to approximately 3 years)|ITT Population|||Participants|||Count of Participants
2577010|NCT02445586|Secondary|Number of Participants by Best Overall Response|The best overall response was defined as the best response, out of all the documented responses over the course of the entire study period, using RECIST v1.1. All measurable and non-measurable lesions were documented at screening and re-assessed at each subsequent tumor evaluation. Response was assessed by the investigator on the basis of physical examinations, computed tomography (CT) scans, and magnetic resonance imaging (MRI). The same radiographic procedure was used throughout the study, and assessments were preferably performed by the same evaluator.|From Baseline up to disease progression or death (assessed at every 9 weeks, up to approximately 3 years)|ITT Population|||Participants|||Count of Participants
2577011|NCT02445586|Secondary|Overall Response Rate|The overall response rate (ORR) was defined as the percentage of participants with best overall response of Complete Response (CR) or Partial Response (PR), confirmed by repeat assessment no less than 4 weeks after the response criteria were first met, using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Participants who either had not achieved CR or PR or were without a post-baseline tumor assessment were to be considered non-responders. All measurable and non-measurable lesions were documented at screening and re-assessed at each subsequent tumor evaluation. Response was assessed by the investigator on the basis of physical examinations, computed tomography (CT) scans, and magnetic resonance imaging (MRI). The same radiographic procedure was used throughout the study, and assessments were preferably performed by the same evaluator. The 95% confidence intervals were calculated using Clopper-Pearson methodology.|From Baseline up to disease progression or death (assessed at every 9 weeks, up to approximately 3 years)|ITT Population|||percentage of participants||95% Confidence Interval|Number
2577012|NCT02445586|Primary|Number of Participants With Adverse Events Leading to Treatment Discontinuation|The number of participants with any adverse event (serious or non-serious) that led to treatment discontinuation during the study was counted. Adverse events (AEs) were encoded according to the Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. More than one adverse event that led to treatment discontinuation may have been reported per participant.|From Baseline until end of study (up to approximately 3 years)|Safety Population|||Participants|||Count of Participants
2577013|NCT02445586|Primary|Number of Participants by Left Ventricular Ejection Fraction (LVEF) Findings Over Time|Left ventricular ejection fraction (LVEF) assessments were performed within 42 days of enrollment and every three treatment cycles by either echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan; ECHO was the preferred method. In order to be eligible for this study, an LVEF greater than or equal to (≥)50% was required at screening. The same method of LVEF assessment for each participant must have been used throughout the study, and to the extent possible, have been obtained at the same institution. The following are definitions for the three categories of LVEF findings: 'Normal' was defined as LVEF ≥45%; 'Abnormal but not clinically significant' was defined as LVEF <45% but not clinically significant in the investigator's judgment; 'Abnormal and clinically significant' was defined as LVEF <45% and clinically significant in the investigator's judgment.|Baseline, every 3 cycles (1 cycle is 21 days) until treatment discontinuation, at Safety Follow-Up (28 days after last dose of study drug) and every 3 months thereafter until end of study (up to approximately 3 years)|Safety Population|||Participants|||Count of Participants
2577014|NCT02445586|Primary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time|Left ventricular ejection fraction (LVEF) assessments were performed within 42 days of enrollment and every three treatment cycles by either echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan; ECHO was the preferred method. In order to be eligible for this study, an LVEF of ≥50% was required at screening. The same method of LVEF assessment for each participant must have been used throughout the study, and to the extent possible, have been obtained at the same institution.|Baseline, every 3 cycles (1 cycle is 21 days) until treatment discontinuation, at Safety Follow-Up (28 days after last dose of study drug) and every 3 months thereafter until end of study (up to approximately 3 years)|Safety Population|||percentage points of LVEF||Standard Deviation|Mean
2577015|NCT02445586|Primary|Number of Participants With Congestive Heart Failure||From Baseline until end of study (up to approximately 3 years)|Safety Population|||Participants|||Count of Participants
2577016|NCT02445586|Primary|Number of Participants With Coagulation Abnormalities Reported as Non-Serious Adverse Events|The number of participants with coagulation laboratory abnormalities reported as non-serious adverse events was counted. Adverse events (AEs) were encoded according to the Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. More than one non-serious adverse event may have been reported per participant. Participants with multiple occurrences of the same non-serious adverse event were only counted once per preferred term.|From Baseline until end of study (up to approximately 3 years)|Safety Population|||Participants|||Count of Participants
2577073|NCT02444793|Secondary|Clearance (CL) of Mogamulizumab-Cycle 5|Clearance (CL) was measured by Dose / AUCtau|Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15|The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.|||mL/hr/kg||Geometric Coefficient of Variation|Geometric Mean
2577017|NCT02445586|Primary|Number of Participants With Serum Chemistry Abnormalities Reported as Non-Serious Adverse Events|The number of participants with serum chemistry laboratory abnormalities reported as non-serious adverse events was counted. Adverse events (AEs) were encoded according to the Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. More than one non-serious adverse event may have been reported per participant. Participants with multiple occurrences of the same non-serious adverse event were only counted once per preferred term.|From Baseline until end of study (up to approximately 3 years)|Safety Population|||Participants|||Count of Participants
2577018|NCT02445586|Primary|Number of Participants With Hematological Abnormalities Reported as Non-Serious Adverse Events|The number of participants with hematological laboratory abnormalities reported as non-serious adverse events was counted. Adverse events (AEs) were encoded according to the Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. More than one non-serious adverse event may have been reported per participant. Participants with multiple occurrences of the same non-serious adverse event were only counted once per preferred term.|From Baseline until end of study (up to approximately 3 years)|Safety Population|||Participants|||Count of Participants
2577019|NCT02445586|Primary|Overall Number of Participants With Non-Serious Adverse Events by Treatment Emergence (TEAE Versus Non-TEAE)|The number of participants with non-serious adverse events was counted according to whether the event was considered a treatment emergent adverse event (TEAE), which is defined as an adverse event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state. Participants with multiple occurrences of non-serious adverse events were only counted once per category.|From Baseline until end of study (up to approximately 3 years)|Safety Population|||Participants|||Count of Participants
2577020|NCT02445586|Primary|Overall Number of Participants With Non-Serious Adverse Events by Event Outcome|The number of participants with non-serious adverse events was counted by the event outcome in the four following categories: resolved with no sequelae, resolved with sequelae, unresolved, or death. More than one non-serious adverse event may have been reported per participant. Participants with multiple occurrences of non-serious adverse events with the same outcome were only counted once per category.|From Baseline until end of study (up to approximately 3 years)|Safety Population; the number analyzed represents participants with at least one non-serious adverse event (denominator).|||Participants|||Count of Participants
2577021|NCT02445586|Primary|Overall Number of Participants With Non-Serious Adverse Events by Action Taken With Pertuzumab|The number of participants with non-serious adverse events was counted by the type of action taken with pertuzumab in response to the adverse event in the three following categories: no action taken, infusion slow down, infusion interrupted, and appropriate medical therapies administered. More than one non-serious adverse event may have been reported per participant. Participants with multiple occurrences of non-serious adverse events that required the same action to be taken with the study drug were only counted once per category.|From Baseline until end of study (up to approximately 3 years)|Safety Population; the number analyzed represents participants with at least one non-serious adverse event (denominator).|||Participants|||Count of Participants
2577022|NCT02445586|Primary|Overall Number of Participants With Non-Serious Adverse Events by Chemotherapy Adjustment With Docetaxel and/or Trastuzumab|The number of participants with non-serious adverse events was counted by the type of action taken with docetaxel and/or trastuzumab in response to the adverse event in the three following categories: no adjustment, dosage modified/interrupted, and discontinued. More than one non-serious adverse event may have been reported per participant. Participants with multiple occurrences of non-serious adverse events that required the same action to be taken with the study drug were only counted once per category.|From Baseline until end of study (up to approximately 3 years)|Safety Population; the number analyzed represents participants with at least one non-serious adverse event (denominator).|||Participants|||Count of Participants
2577023|NCT02445586|Primary|Number of Participants With Non-Serious Adverse Events Related to Trastuzumab|The number of participants with non-serious adverse events was counted for any non-serious adverse event that was related to study treatment with trastuzumab, in the investigator's judgment. Adverse events (AEs) were encoded according to the Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. More than one non-serious adverse event may have been reported per participant. Participants with multiple occurrences of the same non-serious adverse event were only counted once per preferred term.|From Baseline until end of study (up to approximately 3 years)|Safety Population|||Participants|||Count of Participants
2577024|NCT02445586|Primary|Number of Participants With Non-Serious Adverse Events Related to Pertuzumab|The number of participants with non-serious adverse events was counted for any non-serious adverse event that was related to study treatment with pertuzumab, in the investigator's judgment. Adverse events (AEs) were encoded according to the Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. More than one non-serious adverse event may have been reported per participant. Participants with multiple occurrences of the same non-serious adverse event were only counted once per preferred term.|From Baseline until end of study (up to approximately 3 years)|Safety Population|||Participants|||Count of Participants
2577025|NCT02445586|Primary|Number of Participants With Non-Serious Adverse Events Related to Docetaxel|The number of participants with non-serious adverse events was counted for any non-serious adverse event that was related to study treatment with docetaxel, in the investigator's judgment. Adverse events (AEs) were encoded according to the Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. More than one non-serious adverse event may have been reported per participant. Participants with multiple occurrences of the same non-serious adverse event were only counted once per preferred term.|From Baseline until end of study (up to approximately 3 years)|Safety Population|||Participants|||Count of Participants
2577036|NCT02445586|Primary|Number of Participants With Serious Adverse Events Related to Docetaxel|The number of participants with serious adverse events was counted for any serious adverse event that was related to study treatment with docetaxel, in the investigator's judgment. Adverse events (AEs) were encoded according to the Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. More than one serious adverse event may have been reported per participant. Participants with multiple occurrences of the same serious adverse event were only counted once per preferred term.|From Baseline until end of study (up to approximately 3 years)|Safety Population|||Participants|||Count of Participants
2577789|NCT02435511|Other Pre-specified|Self-efficacy - Smoking Cessation as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale|Measure confidence in ability to quit smoking|Baseline, 1 week, 1 month and 3 months|||||||
2577026|NCT02445586|Primary|Overall Number of Participants With Non-Serious Adverse Events by Severity, According to NCI-CTCAE v4.03|"The number of participants with non-serious adverse events was counted by the severity level of the adverse event, assessed as Grades 1-5 according to NCI CTCAE v4.03. Any adverse event not specifically listed in NCI CTCAE v4.03 was assessed according to the following grades of severity: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe or medically significant; Grade 4 is life-threatening or urgent intervention indicated; and Grade 5 is death related to adverse event. The terms severe and serious are not synonymous. Severity refers to the intensity of an adverse event. The seriousness of an adverse event is based on whether it meets any of the criteria set out in the protocol's definition of a serious adverse event. Severity and seriousness were independently assessed for each adverse event. Participants with multiple occurrences of non-serious adverse events of the same severity were only counted once per severity category."|From Baseline until end of study (up to approximately 3 years)|Safety Population; the number analyzed represents participants with at least one non-serious adverse event (denominator).|||Participants|||Count of Participants
2577027|NCT02445586|Primary|Overall Number of Participants by the Number of Non-Serious Adverse Events Reported Per Participant|The number of participants with non-serious adverse events was counted in the four following categories for number of events reported per participant: greater than or equal to (≥) 1, 1, greater than (>) 1, or 0 non-serious adverse events. Participants with multiple occurrences of events (the ≥1 and >1 non-serious adverse event categories) were only counted once per category.|From Baseline until end of study (up to approximately 3 years)|Safety Population|||Participants|||Count of Participants
2577028|NCT02445586|Primary|Number of Participants Who Died Due to a Serious Adverse Event by Cause of Death|The number of participants who died due to a serious adverse event was counted by the cause of death.|From Baseline until end of study (up to approximately 3 years)|Safety Population|||Participants|||Count of Participants
2577029|NCT02445586|Primary|Number of Participants With Coagulation Abnormalities Reported as Serious Adverse Events|The number of participants with coagulation laboratory abnormalities reported as serious adverse events was counted. Adverse events (AEs) were encoded according to the Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. More than one serious adverse event may have been reported per participant. Participants with multiple occurrences of the same serious adverse event were only counted once per preferred term.|From Baseline until end of study (up to approximately 3 years)|Safety Population|||Participants|||Count of Participants
2577030|NCT02445586|Primary|Number of Participants With Serum Chemistry Abnormalities Reported as Serious Adverse Events|The number of participants with serum chemistry laboratory abnormalities reported as serious adverse events was counted. Adverse events (AEs) were encoded according to the Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. More than one serious adverse event may have been reported per participant. Participants with multiple occurrences of the same serious adverse event were only counted once per preferred term.|From Baseline until end of study (up to approximately 3 years)|Safety Population|||Participants|||Count of Participants
2577031|NCT02445586|Primary|Number of Participants With Hematological Abnormalities Reported as Serious Adverse Events|The number of participants with hematological laboratory abnormalities reported as serious adverse events was counted. Adverse events (AEs) were encoded according to the Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. More than one serious adverse event may have been reported per participant. Participants with multiple occurrences of the same serious adverse event were only counted once per preferred term.|From Baseline until end of study (up to approximately 3 years)|Safety Population|||Participants|||Count of Participants
2577032|NCT02445586|Primary|Overall Number of Participants With Serious Adverse Events by Event Outcome|The number of participants with serious adverse events was counted by the event outcome in the six following categories: fatal, recovered/resolved, recovered/resolved with sequelae, recovering/resolving, not recovered/not resolved, or unknown. More than one serious adverse event may have been reported per participant. Participants with multiple occurrences of serious adverse events with the same outcome were only counted once per category.|From Baseline until end of study (up to approximately 3 years)|Safety Population; the number analyzed represents participants with at least one serious adverse event (denominator).|||Participants|||Count of Participants
2577033|NCT02445586|Primary|Overall Number of Participants With Serious Adverse Events by Action Taken With Study Drug|The number of participants with serious adverse events was counted by the type of action taken with the study drug (docetaxel, pertuzumab, and trastuzumab) in response to the adverse event in the three following categories: infusion reduced, temporarily interrupted, or permanently discontinued. More than one serious adverse event may have been reported per participant. Participants with multiple occurrences of serious adverse events that required the same action to be taken with the study drug were only counted once per category.|From Baseline until end of study (up to approximately 3 years)|Safety Population; the number analyzed represents participants with at least one serious adverse event (denominator).|||Participants|||Count of Participants
2577034|NCT02445586|Primary|Number of Participants With Serious Adverse Events Related to Trastuzumab|The number of participants with serious adverse events was counted for any serious adverse event that was related to study treatment with trastuzumab, in the investigator's judgment. Adverse events (AEs) were encoded according to the Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. More than one serious adverse event may have been reported per participant. Participants with multiple occurrences of the same serious adverse event were only counted once per preferred term.|From Baseline until end of study (up to approximately 3 years)|Safety Population|||Participants|||Count of Participants
2577035|NCT02445586|Primary|Number of Participants With Serious Adverse Events Related to Pertuzumab|The number of participants with serious adverse events was counted for any serious adverse event that was related to study treatment with pertuzumab, in the investigator's judgment. Adverse events (AEs) were encoded according to the Medical Dictionary for Regulatory Activities (MedDRA) version 21.1. More than one serious adverse event may have been reported per participant. Participants with multiple occurrences of the same serious adverse event were only counted once per preferred term.|From Baseline until end of study (up to approximately 3 years)|Safety Population|||Participants|||Count of Participants
2577060|NCT02445014|Primary|Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule.|The number of subjects from whom successful SECM imaging was obtained|20 minute visit (5-7 minute imaging)||||Participants|||Count of Participants
2577037|NCT02445586|Primary|Overall Number of Participants With Serious Adverse Events by Severity (Initial and Most Extreme), According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03)|"The number of participants with serious adverse events was counted by the initial and most extreme levels of severity of the adverse event, assessed as Grades 1-5 according to NCI CTCAE v4.03. Any adverse event not specifically listed in NCI CTCAE v4.03 was assessed according to the following grades of severity: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe or medically significant; Grade 4 is life-threatening or urgent intervention indicated; and Grade 5 is death related to adverse event. The terms severe and serious are not synonymous. Severity refers to the intensity of an adverse event. The seriousness of an adverse event is based on whether it meets any of the criteria set out in the protocol's definition of a serious adverse event. Severity and seriousness were independently assessed for each adverse event. Participants with multiple occurrences of serious adverse events of the same severity were only counted once per severity category."|From Baseline until end of study (up to approximately 3 years)|Safety Population; the number analyzed in each category represents the number of participants with at least one serious adverse event (denominator).|||Participants|||Count of Participants
2577038|NCT02445586|Primary|Overall Number of Participants by the Number of Serious Adverse Events Reported Per Participant|The number of participants with serious adverse events was counted in the four following categories for number of events reported per participant: greater than or equal to (≥) 1, 1, greater than (>) 1, or 0 serious adverse events. Participants with multiple occurrences of events (the ≥1 and >1 serious adverse event categories) were only counted once per category.|From Baseline until end of study (up to approximately 3 years)|Safety Population|||Participants|||Count of Participants
2577039|NCT02445573|Other Pre-specified|Adverse Events|Number of participants who experienced Adverse Events was collected.|weeks 1-30||||participants|||Number
2577040|NCT02445573|Secondary|Patient Self-evaluation of Therapeutic Effect|"Participants were asked to rate the extent of help that they received from treatment as no help, little help. moderate help or great help.~Number of participants reporting different extent of help was collected."|weeks 6, 18 and 30||||participants|||Number
2577041|NCT02445573|Secondary|Change From Baseline of the Total ICIQ-SF Scores|The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) was a brief and robust measure for evaluating the symptoms and impact of urinary incontinence.It was used to assess the influence of urinary incontinence on quality of life during the past 4 weeks retrospectively. It contained three items on frequency, amount of leakage, and overall impact on quality of life, and a fourth, non-scored item for the assessment of type of incontinence. A total score was summed by the scores of the first three items, ranging from 0 to 21. A higher value indicates increased severity.|Baseline, and weeks 6, 18 and 30||||units on a scale||Standard Error|Mean
2577042|NCT02445573|Secondary|Change From Baseline of the 72-hour Incontinence Episode Frequency (IEF)|"Data of IEF was from 72-hour bladder diary recorded by participants over the last 72 hours of weeks 0 (baseline), weeks 2, 4, 6 (treatment period) and weeks 15-18,and 27-30 (follow-up period).~The 72-hour IEF of weeks 1-6 equaled the sum of 72h IEF at weeks 2, 4 and 6 divided by 3; The 72-hour IEF of weeks 15-18 equaled the sum of 72h IEF at weeks 15-18 divided by 4; The 72-hour IEF of weeks 27-30 equaled the sum of 72h IEF at weeks 27-30 divided by 4."|Baseline, weeks 1-6, weeks 15-18 and weeks 27-30||||episodes||Inter-Quartile Range|Median
2577043|NCT02445573|Primary|Change From Baseline of Urine Leakage Measured by 1-hour Pad Test||Baseline and week 6||||g||Inter-Quartile Range|Median
2577044|NCT02445326|Primary|Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6|Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None|20 minutes||||units on a scale||Standard Deviation|Mean
2577045|NCT02445326|Primary|Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6|Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None|15 minutes||||units on a scale||Standard Deviation|Mean
2577046|NCT02445326|Primary|Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6|Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None|7 minutes||||units on a scale||Standard Deviation|Mean
2577047|NCT02445326|Primary|Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6|Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None|7 minutes||||units on a scale||Standard Deviation|Mean
2577048|NCT02445326|Primary|Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6|Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None|5 minutes||||units on a scale||Standard Deviation|Mean
2577049|NCT02445326|Primary|Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6|Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None|3 minutes||||units on a scale||Standard Deviation|Mean
2577050|NCT02445287|Primary|Radlex Scale for Diagnostic Quality Ratings - 3D Images SND|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|12 weeks after last image capture|140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers & Human Subjects 3D-SND arm above.|||units on a scale|images|Standard Error|Mean
2577061|NCT02444988|Secondary|30-day In-hospital Mortality|Death before hospital discharge, censored at 30 days after enrollment|30 days after enrollment censored at hospital discharge||||Participants|||Count of Participants
2577107|NCT02444715|Primary|Change in LDL Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. LDL data is missing for 5 of the 46 SC and 11 of the 48 IC participants who started the study.|||mg/dl||Inter-Quartile Range|Median
2577051|NCT02445287|Primary|Radlex Scale for Diagnostic Quality Ratings - 3D Images FDK|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|12 weeks after last image capture|140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers & Human Subjects 3D-FDK arm above.|||units on a scale|images|Standard Error|Mean
2577052|NCT02445287|Primary|Radlex Scale for Diagnostic Quality Ratings - 3D Images High Resolution|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|12 weeks after last image capture|140 image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for the for Reference-Cadavers 3D arm above. 204 image ratings from 4 radiologist readers (35 specimens, + 13 human subjects, + 3 specimens w/o metal correction rated x 4 readers) for the Investigational-Cadavers & Human Subjects 3D-High Resolution arm above.|||units on a scale|images|Standard Error|Mean
2577053|NCT02445287|Primary|Radlex Scale for Diagnostic Quality Ratings - 2D Images|1-1.9-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-2.9-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-3.9-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|12 weeks after last image capture|140 total image ratings from 4 radiologist readers (35 specimens rated x 4 readers) for each of the above two arms.|||units on a scale|images|Standard Error|Mean
2577054|NCT02445196|Secondary|Sustained Change in PTSD Symptoms Measured by the Post Traumatic Stress Disorder Checklist (PCL)|PTSD symptoms were assessed with the PCL-C (Weathers et al., 1993), a 17-item self-report measure of DSM-IV PTSD symptoms with strong psychometric properties (Wilkins, Lang, & Norman, 2011). Items are rated on how much the symptom bothered the respondent in the past month on a scale ranging from 1 (not at all) to 5 (extremely), with the sum score ranging from 17 to 85 providing a symptom severity rating, with higher ratings indicating more severe PTSD symptoms.|Postreatment to 3-month Follow-up||||units on a scale||Standard Deviation|Mean
2577055|NCT02445196|Secondary|Change in Depression Symptoms Measured by the Patient Health Questionnaire (PHQ8)|Depression was assessed with the Patient Health Questionnaire depression scale (PHQ-8; Kroenke et al., 2009), an 8-item self-report measure of depression with evidence showing its ability to measure depression symptom severity and potential diagnosis. Items are rated on how much the symptom bothered the respondent in the past two weeks on a scale ranging from 0 (not at all) to 3 (nearly every day). Total scores can range from 0 to 24, with higher scores indicating more severe depression symptoms. Cronbach's alpha at baseline was .87.|Baseline to Posttreatment (3 months)||||units on a scale||Standard Deviation|Mean
2577056|NCT02445196|Secondary|Change in Interpersonal Functioning Measured by a Brief Inventory of Psychosocial Functioning (IPF7)|Psychosocial functioning was measured using the Brief Inventory of Psychosocial Functioning (B-IPF; Erb, Kearns, Bovin et al., 2015), a 7-item self-report measure. Items are rated on how much trouble the respondent had in the past month in relationships or other important areas of functioning (e.g., work, training or education) on a scale ranging from 0 (not at all) to 6 (very much). An average of applicable items provides an index of psychosocial functioning, with higher scores reflecting more poorer psychosocial functioning. Cronbach's alpha at baseline was .82.|Baseline to Posttreatment (3 months)||||units on a scale||Standard Deviation|Mean
2577057|NCT02445196|Secondary|Change in Subject Coping Self-efficacy Measured by a Questionnaire Assessing Confidence in Managing Core Symptoms of PTSD Addressed in the Intervention|PTSD symptom coping SE was assessed with a 9-item self-report measure developed for the study following Bandura's guidelines (Bandura, 2006). Items assess confidence in managing PTSD symptoms and reaching out for support on a scale from 0 (cannot do at all) to 100 (highly certain can do). The average score provides an overall measure of SE with higher scores reflecting greater self-efficacy coping with PTSD symptoms. Cronbach's alpha at baseline was .87.|Baseline to Posttreatment (3 months)||||units on a scale||Standard Deviation|Mean
2577058|NCT02445196|Primary|Change in PTSD Symptoms Measured by the Post Traumatic Stress Disorder Checklist (PCL)|PTSD symptoms were assessed with the PCL-C (Weathers et al., 1993), a 17-item self-report measure of DSM-IV PTSD symptoms with strong psychometric properties (Wilkins, Lang, & Norman, 2011). Items are rated on how much the symptom bothered the respondent in the past month on a scale ranging from 1 (not at all) to 5 (extremely), with the sum score ranging from 17 to 85 providing a symptom severity rating, with higher ratings indicating more severe PTSD symptoms.|Baseline to Posttreatment (3 months)||||units on a scale||Standard Deviation|Mean
2577059|NCT02445027|Primary|Feasibility of Esophageal Imaging in Subjects Who Successfully Swallow the OCT Capsule in the Primary Care Setting.|Number of Participants able to swallow the capsule successfully. An investigator will assess the quality of the recorded images and movies obtained with each exam after imaging has been completed. This is a feasibility study and was not used for any diagnosis.|Approximate 20min visit (5min image acquisition)||||Participants|||Count of Participants
2577062|NCT02444988|Primary|Major Adverse Kidney Event Within 30 Days|The primary outcome was the proportion of patients who met one or more criteria for a major adverse kidney event within 30 days — the composite of death, new receipt of renal-replacement therapy, or persistent renal dysfunction (defined as a final inpatient creatinine value ≥200% of the baseline value) — all censored at hospital discharge or 30 days after enrollment, whichever came first.|30 days after enrollment censored at hospital discharge|Of the 15,802 patient enrolled in the SMART trial, 5381 were admitted to the medical ICU, 2646 in the saline group and 2735 in the balanced crystalloid group.|||Participants|||Count of Participants
2577063|NCT02444936|Primary|Measuring the Safety of ZOSTAVAX Given to Chemotherapy Patients (Vaccine Report Card (VRC) to Document Injection-site Adverse Experiences, Systemic Clinical Adverse Experiences (AEs), Concomitant Medications, and Oral Temperatures|To asses the safety of ZOSTAVAX given to subjects that will receive chemotherapy or surgery and then chemotherapy for solid organ tumor at least 14 days after vaccination. Safety and tolerability data will be collected for all subjects throughout the study. Each subject will be given a Vaccine Report Card (VRC) to document injection-site adverse experiences, systemic clinical adverse experiences (AEs), concomitant medications, and oral temperatures (only if feeling feverish) noted during the 14-day post-vaccination period. Participants will be asked to notify the study personnel immediately if any unexpected or serious adverse experience (SAE) occurs. At all study visits subjects will be asked about any unreported SAEs. All AEs and SAEs will be recorded on an AE/SAE case report form and relationship to study vaccine will be determined by the site investigator.|3 years||||Participants|||Count of Participants
2577064|NCT02444936|Primary|Measuring the Efficacy of ZOSTAVAX in Chemotherapy Patients (Changes in ZOSTAVAX-specific IFN-gamma Spot Forming Units Will be Measured by ELISPOT)|To examine the cellular immunologic efficacy as measured by IFN-gamma assays of ZOSTAVAX given to individuals with solid organ tumors at least 14 days prior to initiation of chemotherapy or surgery and then chemotherapy. Changes in ZOSTAVAX-specific IFN-gamma spot forming units will be measured by ELISPOT.|3 years|||||||
2577065|NCT02444793|Secondary|Progression Free Survival (PFS) and Immune-related PFS (irPFS) - Dose Expansion Portion|PFS was defined as the time from the date of first dose of study treatment to the date of the first documentation of PD or death due to any cause, whichever occurred first. irPFS was defined as the time from the first dose of study treatment to the date of first documentation of irPD (which was subsequently confirmed) or death due to any cause, whichever occurred first. PD:20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.|Every 8 weeks up to 24 months|No participants were enrolled in the dose-expansion portion.||||||
2577066|NCT02444793|Secondary|Duration of Response (DR) and Immune-related DR (irDR) -Dose Expansion Portion|DR was defined, for participants with an OR, as the time from first documentation of OR (CR or PR) to the date of first documentation of objective progression disease (PD) or death due to any cause. irDR was defined, for participants with an irOR, as the time from the first documentation of irOR (irCR or irPR) to the date of first documentation of immune-related PD (irPD) (which was subsequently confirmed) or death due to any cause. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions; PD: 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.|Every 8 weeks from the first occurrence of CR or PR, until disease progression or death up to 24 months|No participants were enrolled in the dose-expansion portion.||||||
2577067|NCT02444793|Secondary|Time to Response (TTR) and Immue-related Time to Response (irTTR)-Dose Expansion Portion|TTR was defined, for participants with an OR, as the time from the date of first dose of study treatment to the first documentation of OR (CR or PR), which was subsequently confirmed. irTTR was defined, for participants with an irOR, as the time from the first dose of study treatment to the first documentation of irOR (irCR or irPR) which was subsequently confirmed. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.|Every 8 weeks up to 24 months|No participants were enrolled in the dose-expansion portion.||||||
2577068|NCT02444793|Secondary|Number of Participants With Objective Response (OR) and Immune-related Objective Response (irOR)|OR was defined as best overall response (BOR) of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Immune-related OR (irOR) was defined as immune-related BOR (irBOR) of immune-related CR (irCR) and immune-related PR (irPR) according to immune-related RECIST. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.|Every 8 weeks up to 24 months|The full analysis set included all enrolled participants.|||Participants|||Count of Participants
2577069|NCT02444793|Secondary|Neutralizing Antibodies (NAb) Titers for Mogamulizumab|ADA positive samples were further analyzed for NAb using a validated assay|Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months|Number of participants analyzed was determined as participants with treatment-induced NAb.||||||
2577070|NCT02444793|Secondary|Anti-Drug Antibody (ADA) Titers for Mogamulizumab|Serum samples were assayed for ADA using a validated analytical method.|Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months|Number of participants analyzed was determined as participants with treatment-induced ADA.|||Titer||Inter-Quartile Range|Median
2577071|NCT02444793|Secondary|Neutralizing Antibodies (NAb) Titers for PF-05082566|ADA positive samples were further analyzed for NAb using a validated assay.|Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months|Number of participants analyzed was determined as participants with treatment-induced NAb.|||Titer||Inter-Quartile Range|Median
2577072|NCT02444793|Secondary|Anti-Drug Antibody (ADA) Titer for PF-05082566|Serum samples were assayed for ADA using a validated analytical method.|Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months|Number of participants analyzed was determined as participants with treatment-induced ADA.|||Titer||Inter-Quartile Range|Median
2577108|NCT02444715|Primary|Change in HDL Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. HDL data is missing for 5 of the 46 SC and 11 of the 48 IC participants who started the study.|||mg/dl||Inter-Quartile Range|Median
2577074|NCT02444793|Secondary|Area Under the Serum Concentration-time Profile From Time 0 to Time Tau (AUCtau) of Mogamulizumab-Cycle 5|AUCtau was area under the serum concentration-time profile from time 0 to time tau, the dosing interval, where tau=336 hours|Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15|The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.|||μg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2577075|NCT02444793|Secondary|Area Under the Serum Concentration-time Profile From Time 0 to 168 Hours (AUC168) of Mogamulizumab-Cycle 1|AUC168 was area under the serum concentration-time profile from time 0 to 168 hours post dose (Cycle 1 only where dosing was once a week), which was measured by Linear/Log trapezoidal method.|Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22|The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.|||μg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2577076|NCT02444793|Secondary|AUClast of Mogamulizumab-Cycles 1 and 5|AUClast was area under the serum concentration-time profile from time 0 to the time of the last measurable concentration (Clast), which was measured by Linear/Log trapezoidal method.|Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15|The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.|||μg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2577077|NCT02444793|Secondary|Dose Normalized AUClast of PF-05082566-Cycle 5|Dose normalized AUClast was calculated by AUClast / Dose|Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.|The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.|||µg•hr/mL/mg/kg||Geometric Coefficient of Variation|Geometric Mean
2577078|NCT02444793|Secondary|Area Under the Serum Concentration-time Profile From Time 0 to the Time of the Last Measurable Concentration (AUClast) of PF-05082566-Cycle 5|AUClast was area under the serum concentration-time profile from time 0 to the time of the last measurable concentration (Clast), which was measured by Linear/Log trapezoidal method.|Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.|The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.|||μg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2577079|NCT02444793|Secondary|Tlast of Mogamulizumab-Cycles 1 and 5|Time of last measurable concentration was observed directly from the data.|Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15|The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.|||hour||Full Range|Median
2577080|NCT02444793|Secondary|Tmax of Mogamulizumab-Cycles 1 and 5|Time for Cmax (Tmax) was observed directly from the data.|Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15|The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.|||hour||Full Range|Median
2577081|NCT02444793|Secondary|Time of Last Measurable Concentration (Tlast) of PF-05082566-Cycle 5|Time of last measurable concentration was observed directly from data.|Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.|The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.|||hour||Full Range|Median
2577082|NCT02444793|Secondary|Time for Cmax (Tmax) of PF-05082566-Cycle 5|Time for Cmax (Tmax) was observed directly from the data.|Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.|The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.|||hour||Full Range|Median
2577083|NCT02444793|Secondary|Ctrough of Mogamulizumab- Cycle 5|Pre-dose Concentration during Multiple Dosing (Ctrough) was observed directly from data.|Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15|The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2577084|NCT02444793|Secondary|Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566-Cycle 5|Pre-dose Concentration during Multiple Dosing (Ctrough) was observed directly from data|Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.|The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2577085|NCT02444793|Secondary|Cmax of Mogamulizumab-Cycles 1 and 5|Maximum Observed Serum Concentration (Cmax) was observed directly from the data.|Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15|The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2577086|NCT02444793|Secondary|Dose Normalized Cmax of PF-05082566-Cycle 5|Dose normalized Cmax was calculated by Cmax / Dose|Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.|The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.|||µg/mL/mg/kg||Geometric Coefficient of Variation|Geometric Mean
2577087|NCT02444793|Secondary|Maximum Observed Serum Concentration (Cmax) of PF-05082566-Cycle 5|Maximum Observed Serum Concentration (Cmax) was observed directly from the data.|Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion.|The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2577088|NCT02444793|Secondary|Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Shift to Grades 2, 3, 4 or 5|ECOG performance status was classified as 5 grades: 0 (Fully active, able to carry on all predisease performance without restriction); 1 (Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, ie, light house work, office work); 2 (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours); 3 (Capable of only limited self care, confined to bed or chair more than 50% of waking hours); 4 (Completely disabled. Cannot carry on any self care. Totally confined to bed or chair); 5 (Death). On-study shifts to ECOG performance statuses of 2, 3, 4 or 5 were reported.|Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment|All enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2577089|NCT02444793|Secondary|Number of Participants With Significant Changes From Baseline in Physical Examination|Physical examination included an examination of major body systems, including general, head, ears, eyes, nose, mouth, throat, neck, lungs, heart, abdomen, musculoskeletal, lymph nodes, neurological and external genitalia. Significant changes from baseline were reported in each category.|Cycle 2 Day 1; End of the treatment.|All enrolled participants who received at least 1 dose of study treatment. Number analyzed was the number of participants at the given category.|||Participants|||Count of Participants
2577090|NCT02444793|Secondary|Number of Participants With Clinical Significant Observations in Vital Signs|Blood pressure (BP) and pulse rate were recorded in supine or sitting position.|Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment|All enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2577091|NCT02444793|Secondary|Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4|The chemistry laboratory tests included: Alanine aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Lactate Dehydrogenase, Sodium, Potassium, Magnesium, Total Calcium, Phosphorus or Phosphate, Total bilirubin, Creatinine or creatinine clearance, Albumin, Total proteins, Uric Acid, BUN or Urea, Immunoglobulin G, Glucose (fasted).|Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment|All enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2577092|NCT02444793|Secondary|Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4|The hematology laboratory tests include: Anemia, Hemoglobin increased, Lymphocyte count increased, Lymphopenia, Neutrophils (absolute), Platelets, White blood cells.|Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment|All enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2577093|NCT02444793|Secondary|Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related)|An AE was any untoward medical occurrence in a participant administered a product or medical device has a causal relationship with Mogamulizumab. SAEs were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs.|Day 1 up tp 60 days after last dose of study treatment|All enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2577094|NCT02444793|Secondary|Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related)|An AE was any untoward medical occurrence in a participant administered a product or medical device has a causal relationship with PF-05082566. SAEs were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs.|Day 1 up to 60 days after last dose of study treatment|All enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2577109|NCT02444715|Primary|Change in Systolic Blood Pressure||baseline and 6 months|Blood pressure data is missing for 4 of the 36 SC and 4 of the 32 IC participants who provided final questionnaires.|||mmHg||Standard Deviation|Mean
2577126|NCT02443883|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group.|Predose Cycle 1 Through Short Term Follow Up (Up to 5 Months)|All randomized participants who received at least 1 dose of ramucirumab and had evaluable anti-ramucirumab antibody measurement.|||Participants|||Count of Participants
2577095|NCT02444793|Secondary|Number of Participants With Treatment-Emergent Adverse Events (All Causalities)|An AE was any untoward medical occurrence in a participant administered a product or medical device without regard to possibility of causal relationship. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs.|Day 1 up to 60 days after last dose of study treatment|All enrolled participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2577096|NCT02444793|Primary|Number of Participants With Dose Limiting Toxicities (DLT)|DLTs was defined as any of the following adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at first 2 Cycles. Hematologic: (1) Grade 4 neutropenia lasting >7 days; (2) Febrile neutropenia, defined as absolute neutrophil count (ANC) <1000/mm3 with a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees F) for more than 1 hour; (3) Grade >=3 neutropenic infection; (4) Grade >=3 thrombocytopenia with bleeding; (5) Grade 4 thrombocytopenia. Non-Hematologic: (1) Grade >=3 non laboratory toxicities (excluding infusion reactions), except those that had not been maximally treated (eg, nausea, vomiting, diarrhea); (2) Grade >=3 laboratory abnormalities (other than aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) if: Medical intervention was required to treat the participant, or The abnormality led to hospitalization; (3) Grade 4 AST and ALT increase.|First 2 Cycles (28 days in each cycle)|All enrolled participants who were eligible for the study and received study treatment.|||Participants|||Count of Participants
2577097|NCT02444715|Other Pre-specified|Usability: SUS Score|"The usability of the intervention was assessed based on the standardised System Usability Scale (SUS).~SUS scores were not collected in the SC group because the SC participants were not using CAPSYS and hence were not able to assess its usability.~The System Usability Scale (SUS) provides a quick and dirty, reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Originally created by John Brooke in 1986, it allows to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications.~The total SUS score computed based on the responses provided to each of the 10 items can range from 0 (worst) to 100 (best). Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average."|6 months|SUS questionnaires are missing, incomplete or invalid for 6 of the 32 IC participants who provided final questionnaires.|||units on a scale (total SUS score)||Standard Deviation|Mean
2577098|NCT02444715|Secondary|Change in Quality of Life|"The QoL was measured using the standardised EQ-5D-5L instrument provided by the EuroQol Group.~In this context, the health value was specified by the participants on a subjective scale ranging from 0 (The worst health you can imagine) to 100 (The best health you can imagine)."|baseline and 6 months|Data on quality of life was retrieved from final questionnaires. Hence, QoL data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.|||units on a scale (health value)||Inter-Quartile Range|Median
2577099|NCT02444715|Secondary|Change in Duration of Physical Activity|Self-reported weekly duration of physical activity of medium or high intensity|baseline and 6 months|Data on physical activity was retrieved from final questionnaires. Hence, physical activity data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.|||minutes||Inter-Quartile Range|Median
2577100|NCT02444715|Secondary|Change in Sweets Consumption|"Self-reported weekly portions of sweets consumption~(During the recruiting interview, participants were instructed in estimating the size of a portion of sweets and they were provided an information booklet on this topic.)"|baseline and 6 months|Data on sweets consumption was retrieved from final questionnaires. Hence, food consumption data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.|||portions||Inter-Quartile Range|Median
2577101|NCT02444715|Secondary|Change in Whole Grain Food Consumption|"Self-reported weekly portions of whole grain food consumption~(During the recruiting interview, participants were instructed in estimating the size of a portion of whole grain food and they were provided an information booklet on this topic.)"|baseline and 6 months|Data on whole grain food consumption was retrieved from final questionnaires. Hence, food consumption data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.|||portions||Inter-Quartile Range|Median
2577102|NCT02444715|Secondary|Change in Fruits and Vegetables Consumption|"Self-reported weekly portions of fruits and vegetables consumption~(During the recruiting interview, participants were instructed in estimating the size of a portion of fruits or vegetables and they were provided an information booklet on this topic.)"|baseline and 6 months|Data on fruits and vegetables consumption was retrieved from final questionnaires. Hence, food consumption data is missing for the 10 SC and 16 IC participants who did not provide final questionnaires.|||portions||Inter-Quartile Range|Median
2577103|NCT02444715|Primary|Change in BMI Value||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. Weight data is missing for 9 of the 46 SC and 15 of the 48 IC participants who started the study.|||kg/m^2||Standard Deviation|Mean
2577104|NCT02444715|Primary|Change in Glycaemia Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. Glycaemia data is missing for 6 of the 46 SC and 13 of the 48 IC participants who started the study.|||mg/dl||Inter-Quartile Range|Median
2577105|NCT02444715|Primary|Change in HbA1c Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. HbA1c data is missing for 21 of the 46 SC and 21 of the 48 IC participants who started the study.|||percent HbA1c||Inter-Quartile Range|Median
2577106|NCT02444715|Primary|Change in Triglyceride Level||baseline and 6 months|For participants who did not provide final questionnaires, data was retrieved from medical records. Triglyceride data is missing for 16 of the 46 SC and 16 of the 48 IC participants who started the study.|||mg/dl||Inter-Quartile Range|Median
2577110|NCT02444533|Secondary|Number of Subjects With Post-tonsillectomy Bleeding|The rate of post-tonsillectomy bleeding will be recorded and compared to the arm who did not receive the injection.|4 weeks|In the Liposomal Bupivacaine arm, 15 subjects had data on the primary endpoints, and an additional 2 provided information regarding post-procedure complications, but didn't provide data on other outcomes, therefore the analysis population for the Liposomal Bupivacaine is 17.|||Participants|||Count of Participants
2577111|NCT02444533|Secondary|Number of Subjects Experiencing Complications ( Allergic Reaction, Swallowing Dysfunction, Hospital Admission Related to the Study Drug)|Patients will be monitored for drug related complications such as allergic reaction, swallowing dysfunction, hospital admission related to the study drug.|4 weeks||||Participants|||Count of Participants
2577112|NCT02444533|Primary|Oral Intake (Patient Recorded Oral Intake)|Subjects recorded oral intake over one week after surgery|1 week after surgery||||mL||Standard Deviation|Mean
2577113|NCT02444533|Primary|Pain Medication Usage (Milligrams Used)|Subjects recorded pain medication usage in milligrams used of Tylenol, Ibuprofen, and Oxycodone over a 2 week time frame|2 weeks after surgery|One subject on the no treatment arm was excluded for lack of follow up data, therefore 18 (from participant flow) -1 = 17.|||mg||Standard Deviation|Mean
2577114|NCT02444533|Primary|Pain Score (Pain Scores on a 0/10 Scale)|"Subjects recorded pain scores four times a day in a daily pain diary using a Visual Analog Scale with markings from 0 to 10. 0 indicated no pain and 10 indicated worst possible pain"|day of surgery, 14 days after surgery|Results include only subjects who were reported as having at least partial outcome data.|||units on a scale||Standard Deviation|Mean
2577115|NCT02444234|Primary|Time to Peak Sputum Concentration (Tmax)|Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose|2 days|One patient could not produce sputum|||hours||Standard Deviation|Mean
2577116|NCT02444234|Primary|Area Under the Sputum Concentration Versus Time Curve (AUC)|AUC was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose|2 days|One patient could not produce sputum|||mg*h/mL||Standard Deviation|Mean
2577117|NCT02444234|Primary|Peak Sputum Concentration|Peak sputum concentration was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose|2 days|One patient could not produce sputum|||mg/liter||Standard Deviation|Mean
2577118|NCT02444234|Primary|Time to Peak Plasma Concentration (Tmax)|Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose|2 days||||hours||Standard Deviation|Mean
2577119|NCT02444234|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC)|Area under the curve was calculated using samples collected at baseline (0 h) , 0.5, 1, 2, 3, 4, 8, 24, and 48 hours post-dose and using the equation AUC=Dose*F/CL|2 days||||mg*h/mL||Standard Deviation|Mean
2577120|NCT02444234|Primary|Peak Plasma Concentration (Cmax)|Cmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose|2 days||||mg/liter||Standard Deviation|Mean
2577121|NCT02444182|Primary|Plaque Index|"A modified Quickley-Hein plaque index (PI) was used to record the buccal and lingual surfaces of all teeth (from right second molar to left second molar) 0 = no plaque~= separate flecks of plaque at the cervical margin of the tooth~= a thin continuous band of plaque at the cervical margin~= a band of plaque wider than 1 mm but covering less than 1/3 of the crown~= plaque covering at least 1/3 but less than 2/3 of the crown~= plaque covering 2/3 or more of crown~An index for the entire mouth is determined by dividing the total score by the number surfaces (a maximum of 2 x 2 x 14 = 56 surfaces) examined.~** Plaque index score reported in the table below represents Pl for the entire mouth. the range is between 0 (no plaque) to 5 (maximum plaque coverage)"|four weeks||||units on a scale||Standard Deviation|Mean
2577122|NCT02444182|Primary|Gingival Health|"The gingival Index of Loe and Silness (1963) was used to record all surfaces (buccal, lingual, mesial, distal) for index teeth (16, 12, 24, 36, 32, 44). Gingival pockets were gently touched with a periodontal probe and possible bleeding was registered.~The criteria are:~0 = no inflammation~= mild inflammation, slight change in color, slight edema, no bleeding on probing~= moderate inflammation, moderate glazing, redness, bleeding on probing~= severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding~The GI of the tooth was determined by adding the scores of the four surfaces and divided the total by four.~The GI of the individual was obtained by adding the values of each tooth and dividing by the number of teeth examined~A score from 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation, and 2.1-3.0 = severe inflammation"|Four weeks||||units on a scale||Standard Deviation|Mean
2577123|NCT02444143|Secondary|Difference in Time to Therapeutic Level|Difference in the time to a therapeutic tacrolimus trough level in the aBW group compared to the IBW group.|Days 1 to 7||||days||Standard Deviation|Mean
2577124|NCT02444143|Primary|Difference in Tacrolimus Exposure (AUC-0-24)) in Obese Patients Who Received an Initial TAC -ER Dose of 0.15 mg/kg Using aBW Versus IBW|Difference in tacrolimus exposure (area under the concentration-time curve from time 0 to 24 hours (AUC-0-24)) in obese patients who received an initial TAC -ER dose of 0.15 mg/kg using aBW versus IBW|Days 1-14|This study randomized de novo kidney transplant recipients who were at least 18 years of age and obese as evidenced by a BMI ≥ 30 on the day of transplantation.|||ng•h/mL||Standard Deviation|Mean
2577125|NCT02443883|Secondary|Rate of Progression Free Survival at 6 Weeks|PFS defined as time from first day of therapy to first evidence of disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause.Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions,with reference being the smallest sum on study and plus absolute increase of at least 5 mm,or unequivocal progression of non-target lesions,or 1 or more new lesions. If participant does not have complete baseline disease assessment,then PFS time will be censored at date of first dose,regardless of whether or not objectively determined disease progression or death has been observed for participant.If participant is not known to have died or have objective progression as of data inclusion cutoff date for analysis,PFS time will be censored at last adequate tumor assessment date.PFS survival rate at 6 weeks was estimated using the Kaplan-Meier method which takes into consideration who was censored prior to 6 weeks.|Baseline until Disease Progression or Death Due to Any Cause Up to 6 Weeks|All randomized participants. Censored participants: Ramucirumab Regimen 1 = 8, Ramucirumab Regimen 2 = 10, Ramucirumab Regimen 3 = 8 and Ramucirumab Regimen 4 = 12. The survival rate is not a direct result from (number of participants in arm 1 with PFS events up to 6 weeks)/(total number of participants in arm 1).|||Percentage of participants||95% Confidence Interval|Number
2577127|NCT02443883|Primary|Pharmacokinetics: Minimum Concentration (Cmin) of Ramucirumab|The Cmin is the minimum observed serum concentration of ramucirumab.|Week 4, 6, 10 and 12: predose|All randomized participants who received at least one dose of ramucirumab and had evaluable ramucirumab PK data.|||microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2577128|NCT02443805|Secondary|Average Rescue Medication Score (RMS)|Average RMS during the primary evaluation period. Rescue Medication Score (RMS) ; range 0-3, lower is better.|12 months|The FAS included all randomized patients (pts) who received at least one dose of the IP of treatment period and had at least one primary efficacy evaluation during the overall treatment period: 1,476 pts. Among these pts, only those with efficacy evaluation during the primary evaluation period were included in the secondary analysis: 1,262 pts.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2577129|NCT02443805|Secondary|Average Rhinitis Total Symptom Score (RTSS)|"Average RTSS during the primary evaluation period. The daily Total Symptom Scores (RTSS) was the sum of the 4 rhinitis symptom scores: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, each graded on a 4-point scale (0-3; 0: absent, 1: mild, 2: moderate, 3: severe).~It ranges from 0 to 12. Lower is better."|12 months|The FAS included all randomized patients (pts) who received at least one dose of the IP of treatment period and had at least one primary efficacy evaluation during the overall treatment period: 1,476 pts. Among these pts, only those with efficacy evaluation during the primary evaluation period were included in the secondary analysis: 1,262 pts.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2577130|NCT02443805|Primary|Total Combined Score|Average Total Combined Score (TCS), calculated for each patient as the average of the non-missing daily TCSs during the primary evaluation period. The daily TCS (scale 0-15) was the sum of the patient's daily Rhinitis Total Symptom Score (RTSS, scale 0-12) and daily Rescue Medication Score (RMS, scale 0-3). Lower is better.|12 months|The FAS included all randomized patients (pts) who received at least one dose of the IP of treatment period and had at least one primary efficacy evaluation during the overall treatment period: 1,476 pts. Among these pts, only those with efficacy evaluation during the primary evaluation period were included in the primary analysis: 1,262 pts.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2577131|NCT02443792|Secondary|Infection|Proportion experiencing post-op infection, determined clinically (treated with antibiotics)|Up to 4 weeks||||participants|||Number
2577132|NCT02443792|Secondary|Wound Dehiscence|Proportion experiencing wound dehiscence (< 2 cm vs > 2 cm)|Up to 4 weeks||||participants|||Number
2577133|NCT02443792|Secondary|Completely Healed at 4 Weeks|Number of participants who were completely healed at 4 weeks|At the 4-week followup visit||||participants|||Number
2577134|NCT02443792|Secondary|Surgical Pain 0=no Pain; 10=Worst Pain Ever|Self-described pain severity during procedure (scale 1 to 10). 0=no pain, 5=moderate pain, 10=worst pain ever|Up to 30 minutes||||units on a scale||Standard Deviation|Mean
2577135|NCT02443792|Primary|Time Elapsed From First Clamp (Surgical) or Start of Insertion of Bell (Unicirc) to Beginning of Wound Dressing|Time elapsed from first clamp (surgical) or start of insertion of bell (Unicirc) to beginning of wound dressing|Up to 30 minutes||||Minutes||Inter-Quartile Range|Median
2577136|NCT02443740|Secondary|Time to Reach Maximum Observed Cerebrospinal Fluid (CSF) Concentration (Tmax) of PF-05251749||Predose, 1.5, 2.5, 4, and 8 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period. This outcome measure was not planned to be analyzed for Cohort 1, 2 and 4, as pre-specified in protocol.|||hour||Full Range|Median
2577137|NCT02443740|Secondary|Maximum Observed Cerebrospinal Fluid (CSF) Concentration (Cmax) of PF-05251749||Predose, 1.5, 2.5, 4, and 8 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period. This outcome measure was not planned to be analyzed for Cohort 1, 2 and 4, as pre-specified in protocol.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2577138|NCT02443740|Secondary|Area Under the Curve From Time Zero to Extrapolated Cerebrospinal Fluid (CSF) Infinite Time [AUC (0 - ∞)] of PF-05251749|AUC (0 -∞) = Area under the CSF concentration- time profile from time zero extrapolated to infinite time. It was calculated as AUC last + (C last*/k el), where C last* was the predicted CSF concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Predose, 1.5, 2.5, 4, and 8 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period. This outcome measure was not planned to be analyzed for Cohort 1, 2 and 4, as pre-specified in protocol.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2577139|NCT02443740|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Cerebrospinal Fluid (CSF) Concentration (AUClast) of PF-05251749|Area under the CSF concentration-time profile from time zero to the time of last quantifiable concentration (Clast).|Predose, 1.5, 2.5, 4, and 8 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period. This outcome measure was not planned to be analyzed for Cohort 1, 2 and 4, as pre-specified in protocol.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2577140|NCT02443740|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Milled and Unmilled PF-05251749: Cohort 4||Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period. This outcome measure was not planned to be analyzed for Cohort 1, 2 and 3, as pre-specified in protocol.|||hour||Full Range|Median
2577141|NCT02443740|Secondary|Maximum Observed Plasma Concentration (Cmax) of Milled and Unmilled PF-05251749: Cohort 4||Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period. This outcome measure was not planned to be analyzed for Cohort 1, 2 and 3, as pre-specified in protocol.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2577171|NCT02443688|Secondary|Subjects Without a Pulmonary Exacerbation While in the Study|Subjects who did not experience a protocol-defined pulmonary exacerbation during the study|Week 48|Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment.|||Participants|||Count of Participants
2577142|NCT02443740|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Milled and Unmilled PF-05251749: Cohort 4|AUC (0 -∞) = Area under the plasma concentration- time profile from time zero extrapolated to infinite time. It was calculated as AUC last + (C last*/k el), where C last* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period. This outcome measure was not planned to be analyzed for Cohort 1, 2 and 3, as pre-specified in protocol.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2577143|NCT02443740|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Milled and Unmilled PF-05251749: Cohort 4|Area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (Clast).|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period. This outcome measure was not planned to be analyzed for Cohort 1, 2 and 3, as pre-specified in protocol.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2577144|NCT02443740|Secondary|Apparent Volume of Distribution (Vz/F) of PF-05251749|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2577145|NCT02443740|Secondary|Apparent Oral Clearance (CL/F) of PF-05251749|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period.|||liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2577146|NCT02443740|Secondary|Plasma Decay Half-Life (t1/2) of PF-05251749|Terminal elimination half-life (t1/2). It was calculated as dividing the natural logarithm to the base e (Log e)*2/k el, where k el is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period.|||hour||Standard Deviation|Mean
2577147|NCT02443740|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05251749||Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK concentration analysis set included all enrolled participants who were treated and had at least 1 measurable concentration in at least 1 treatment period.|||hour||Full Range|Median
2577148|NCT02443740|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-05251749|AUC (0 -∞) = Area under the plasma concentration- time profile from time zero extrapolated to infinite time. It was calculated as AUC last + (C last*/k el), where C last* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2577149|NCT02443740|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05251749|Area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (Clast ).|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2577150|NCT02443740|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05251749||Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose|The PK analysis set included all enrolled participants who were treated and had at least 1 measurable PK parameter of interest in at least 1 treatment period.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2577151|NCT02443740|Primary|Change From Baseline in Extrapyramidal Symptom Rating Scale (ESRS) at 48 Hours Post Dose in Cohorts 1 and 2|ESRS is a clinician rated scale to assess parkinsonism,dystonia,dyskinesia,akathisia.The ESRS consists of 4 subscales and 4 clinicians global impressions-severity scales(CGI-S scales):I)a questionnaire of extrapyramidal symptoms or drug-induced movement disorders(a series of 4-point Likert scale questions with 0=Absent and 3=Severe);II)an examination of Parkinsonism and akathisia(7-point Likert scale with 0=Absent,6=extremely severe);III)an examination of dystonia(7-point Likert scale with 0=Absent,6=extremely severe);IV)an examination of dyskinesia(7-point Likert scale with 0=normal,6=most severe);V)toVIII)CGI-S scales(9-point Likert scale with 0=Absent,8=extremely severe)of tardive dyskinesia,parkinsonism,dystonia,akathisia.ESRS-Parkinsonism:total score range:0 to 14 where higher scores indicates greater severity;ESRS-dystonia:total score range:0 to 14 where higher scores indicates greater severity.Change from baseline was only observed in examination of parkinsonism and dystonia.|Baseline, Day 1: 48 hours post dose|Safety analysis set included all participants who received at least 1 dose of study treatment. This outcome measure was not planned to be analyzed in Cohort 3 and 4, as pre-specified in protocol.|||units on a scale||Standard Deviation|Mean
2577172|NCT02443688|Secondary|Hazard Ratio Pulmonary Exacerbation While in the Study|Hazard Ratio of pulmonary exacerbation versus placebo for all subjects. Pulmonary exacerbations are defined as treatment with oral, inhaled, or intravenous antibiotic(s) for ≥4 of symptoms/signs per the modified Fuchs criteria.|Week 48|Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.|||hazard ratio||95% Confidence Interval|Number
2577152|NCT02443740|Primary|Change From Baseline in Extrapyramidal Symptom Rating Scale (ESRS) at 2 Hours Post Dose in Cohorts 1 and 2|ESRS is a clinician rated scale to assess parkinsonism,dystonia,dyskinesia,akathisia.The ESRS consists of 4 subscales and 4 clinicians global impressions-severity scales(CGI-S scales):I)a questionnaire of extrapyramidal symptoms or drug-induced movement disorders(a series of 4-point Likert scale questions with 0=Absent and 3=Severe);II)an examination of Parkinsonism and akathisia(7-point Likert scale with 0=Absent,6=extremely severe);III)an examination of dystonia(7-point Likert scale with 0=Absent,6=extremely severe);IV)an examination of dyskinesia(7-point Likert scale with 0=normal,6=most severe);V)toVIII)CGI-S scales(9-point Likert scale with 0=Absent,8=extremely severe)of tardive dyskinesia,parkinsonism,dystonia,akathisia.ESRS-Parkinsonism:total score range:0 to 14 where higher scores indicates greater severity;ESRS-dystonia:total score range:0 to 14 where higher scores indicates greater severity.Change from baseline was only observed in examination of parkinsonism and dystonia.|Baseline, Day 1: 2 hours post dose|Safety analysis set included all participants who received at least 1 dose of study treatment. This outcome measure was not planned to be analyzed in Cohort 3 and 4, as pre-specified in protocol.|||units on a scale||Standard Deviation|Mean
2577153|NCT02443740|Primary|Change From Baseline in Bond and Lader Visual Analogue Scale (BL-VAS) at 48 Hours Post Dose in Cohorts 1 and 2|The BL-VAS monitored the subjective mood of each participant on 16 mood scales. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered (example, alert/drowsy; calm/excited; content/tensed). The individual responses from the 16 mood scales were then combined to make three affective dimensions/subscales a) alertness (average of 9 items [total range 0 to 100, where each item is ordered so that higher scores indicated more alertness]), b) contentment (average of 2 items [total range 0 to 100, where higher scores indicated more contentment]), and c) calmness (average of 5 items [total range 0 to 100, where higher scores indicated more calmness]). Baseline is defined as the last available recording prior to dosing on Day 1 of the first Period.|Baseline, Day 3: 48 hours post dose|Safety analysis set included all participants who received at least 1 dose of study treatment. This outcome measure was not planned to be analyzed in Cohort 3 and 4, as pre-specified in protocol.|||millimeter||Standard Deviation|Mean
2577154|NCT02443740|Primary|Change From Baseline in Bond and Lader Visual Analogue Scale (BL-VAS) at 6 Hours Post Dose in Cohorts 1 and 2|The BL-VAS monitored the subjective mood of each participant on 16 mood scales. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered (example, alert/drowsy; calm/excited; content/tensed). The individual responses from the 16 mood scales were then combined to make three affective dimensions/subscales a) alertness (average of 9 items [total range 0 to 100, where each item is ordered so that higher scores indicated more alertness]), b) contentment (average of 2 items [total range 0 to 100, where higher scores indicated more contentment]), and c) calmness (average of 5 items [total range 0 to 100, where higher scores indicated more calmness]). Baseline is defined as the last available recording prior to dosing on Day 1 of the first Period.|Baseline, Day 1: 6 hours post dose|Safety analysis set included all participants who received at least 1 dose of study treatment. This outcome measure was not planned to be analyzed in Cohort 3 and 4, as pre-specified in protocol.|||millimeter||Standard Deviation|Mean
2577155|NCT02443740|Primary|Change From Baseline in Bond and Lader Visual Analogue Scale (BL-VAS) at 2 Hours Post Dose in Cohorts 1 and 2|The BL-VAS monitored the subjective mood of each participant on 16 mood scales. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered (example, alert/drowsy; calm/excited; content/tensed). The individual responses from the 16 mood scales were then combined to make three affective dimensions/subscales a) alertness (average of 9 items [total range 0 to 100, where each item is ordered so that higher scores indicated more alertness]), b) contentment (average of 2 items [total range 0 to 100, where higher scores indicated more contentment]), and c) calmness (average of 5 items [total range 0 to 100, where higher scores indicated more calmness]). Baseline is defined as the last available recording prior to dosing on Day 1 of the first Period.|Baseline, Day 1: 2 hours post dose|Safety analysis set included all participants who received at least 1 dose of study treatment. This outcome measure was not planned to be analyzed in Cohort 3 and 4, as pre-specified in protocol.|||millimeter||Standard Deviation|Mean
2577156|NCT02443740|Primary|Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Findings|ECG parameters included maximum pulse rate (PR) interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for abnormal ECG: Maximum PR interval >=300 milliseconds (msec) or >=25 percent increase when baseline is >200 msec and >=50 percent increase when baseline is less than or equal to (=<) 200 msec; QRS interval >=140 msec or >=50 percent increase from baseline (IFB); and QTcF 30<=change<60 or change>=60 msec increase. The number of participants with abnormal ECG findings are reported.|Cohort 1 and 2: Baseline up to Week 8, Cohort 3: Baseline up to Week 2, Cohort 4: Baseline up to Week 3|Safety analysis set included all participants who received at least 1 dose of study treatment.|||participants|||Number
2577157|NCT02443740|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Criteria for clinically significant change from baseline in vital signs: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm) or >120 bpm. Maximum increase or decrease from baseline in supine SBP greater than or equal to (>=)30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg.|Cohort 1 and 2: Baseline up to Week 8, Cohort 3: Baseline up to Week 2, Cohort 4: Baseline up to Week 3|Safety analysis set included all participants who received at least 1 dose of study treatment.|||participants|||Number
2577173|NCT02443688|Secondary|Number of Pulmonary Exacerbations Through 48 Weeks|Rate of protocol-defined pulmonary exacerbations reported through the Week 48/Early Termination visit will be annualized where a year is defined by 52 weeks and will be analyzed using a negative binomial regression.|Week 48|Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.|||pulmonary exacerbations per year||95% Confidence Interval|Mean
2577196|NCT02443402|Secondary|Number of Participants With Hypoglycemia During Intensive Care Unit (ICU) Stay|Number of participants with blood glucose (BG) <70 during ICU stay.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
2588892|NCT02299934|Primary|Documentation of Acquisition Time||Day 1|Study was terminated prior to collecting any outcome measure data.||||||
2577158|NCT02443740|Primary|Number of Participants With Laboratory Abnormalities|Hemoglobin(Hgb),hematocrit,red blood cell(RBC):less than(<)0.8*lower limit of normal(LLN), MCV,MCH,MCHC,MPV:<0.9*LLN or >1.1*upper limit of normal(ULN), platelet:<0.5*LLN or >1.75*ULN, white blood cell(WBC):<0.6*LLNor>1.5*ULN, lymphocyte,neutrophil,total neutrophil:<0.8*LLN or >1.2*ULN,basophil,eosinophil,monocyte:>1.2*ULN; PTT, PT:>1.1*ULN,Fibrinogen<0.75*ULNor>1.25ULN; total, direct, indirect bilirubin >1.5*ULN,aspartate aminotransferase,alanine aminotransferase,gamma-glutamyl transferase,alkaline phosphatase:> 3.0*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;blood urea nitrogen,creatinine:>1.3*ULN,uric acid>1.2*ULN;sodium:<0.95*LLN or>1.05*ULN,potassium,chloride, calcium,magnesium,bicarbonate:<0.9*LLN or >1.1*ULN, phosphate<0.8*LLN or >1.2*ULN; glucose <0.6*LLN or >1.5*ULN,creatine kinase>2.0*ULN;urine(specific gravity<1.003or>1.030,pH <4.5or>8,glucose,ketone,protein,blood/Hgb,bilirubin,leukocyte esterase,crystals>=1,RBC,WBC >=20*ULN,bacteria>20);CSF (WBC>=6,RBC>0,Albumin>35).|Cohort 1 and 2: Baseline up to Week 8, Cohort 3: Baseline up to Week 2, Cohort 4: Baseline up to Week 3|Safety analysis set included all participants who received at least 1 dose of study treatment.|||participants|||Number
2577159|NCT02443740|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|For Cohort 1 and 2: Baseline up to Week 8, Cohort 3: Baseline up to Week 2, Cohort 4: Baseline up to Week 3|Safety analysis set included all participants who received at least 1 dose of study treatment.|||participants|||Number
2577160|NCT02443688|Post-Hoc|Number of Pulmonary Exacerbation by Baseline FEV1 Percent Predicted at Week 48|Rate of protocol-defined pulmonary exacerbations reported through the Week 48/Early Termination visit will be annualized where a year is defined by 52 weeks and will be analyzed using a negative binomial regression.|Week 48|Subject's FEV1 percent predicted at screening are presented below.|||pulmonary exacerbations per year||95% Confidence Interval|Mean
2577161|NCT02443688|Other Pre-specified|Subjects Without a Pulmonary Exacerbation by Subjects if Taking CFTR-Modulator Therapy at Baseline|Subjects who did not experience a protocol-defined pulmonary exacerbation during the study.|Week 48|Population of subjects taking CFTR modulating therapy at Baseline.|||Participants|||Count of Participants
2577162|NCT02443688|Other Pre-specified|Hazard Ratio Pulmonary Exacerbation by Subjects if Taking CFTR-Modulator Therapy at Baseline|Hazard Ratio pulmonary exacerbation versus placebo for all subjects taking CFTR-modulating therapy at Baseline|Week 48|Population of subjects taking CFTR modulating therapy at Baseline. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.|||hazard ratio||95% Confidence Interval|Number
2577163|NCT02443688|Other Pre-specified|Number of Pulmonary Exacerbation by Subjects if Taking CFTR-Modulator Therapy at Baseline|Rate of protocol-defined pulmonary exacerbations reported through the Week 48/Early Termination visit will be annualized where a year is defined by 52 weeks and will be analyzed using a negative binomial regression.|Week 48|Population of subjects taking CFTR modulating therapy at Baseline. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.|||pulmonary exacerbations per year||95% Confidence Interval|Mean
2577164|NCT02443688|Other Pre-specified|Subjects Without a Pulmonary Exacerbation by Participants With ppFEV1 >75 at Baseline|Subjects who did not experience a protocol-defined pulmonary exacerbation during the study.|Week 48|Population of subjects with Baseline ppFEV1 >75.|||Participants|||Count of Participants
2577165|NCT02443688|Other Pre-specified|Hazard Ratio Pulmonary Exacerbation for Participants With ppFEV1 >75 at Baseline|Hazard ratio of pulmonary exacerbation versus placebo for all subjects|Week 48|Population of subjects with Baseline ppFEV1 >75. The statistical analysis plan states the two active doses will be compared to placebo individually as well as pooled.|||hazard ratio||95% Confidence Interval|Number
2577166|NCT02443688|Other Pre-specified|Number of Pulmonary Exacerbation Per Year for Participants With ppFEV1 >75 at Baseline|Rate of protocol-defined pulmonary exacerbations reported through the Week 48/Early Termination visit will be annualized where a year is defined by 52 weeks and will be analyzed using a negative binomial regression.|Week 48|Population of subjects with Baseline ppFEV1 >75. The statistical analysis plans states the two active doses will be compared to placebo individually as well as combined. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.|||pulmonary exacerbations per year||95% Confidence Interval|Mean
2577167|NCT02443688|Secondary|Change From Baseline for C-reactive Protein (Hs-CRP)|Results were only calculated in subjects who had a verifiable result at the Baseline and Week 48 visits.|Baseline, Week 48|Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment and who had results at Baseline and Week 48. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.|||mg/dL||95% Confidence Interval|Mean
2577168|NCT02443688|Secondary|Change From Baseline for Specified Biomarkers|Results were only calculated in subjects who had a verifiable result at the Baseline and Week 48 visits.|Baseline, Week 48|Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment and who had results at Baseline and Week 48. The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.|||log10(mcg/mL)||95% Confidence Interval|Mean
2577169|NCT02443688|Secondary|Change From Baseline at 48 Weeks for Forced Vital Capacity Percent Predicted (FVC) and FEF25-75% (Forced Expiratory Flow During the Middle Half of the Forced Vital Capacity) Percent Predicted||Baseline, Week 48|Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. (Observed Data). The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.|||absolute change of percent predicted||95% Confidence Interval|Mean
2577170|NCT02443688|Secondary|Relative Change (Percent Change) From Baseline in ppFEV1|Percent change from Baseline for ppFEV1 at 48 weeks was assessed.|Baseline, Week 48|Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. (Observed Data). The statistical analysis plans states the two active doses will be compared to placebo individually as well as pooled.|||percent change from baseline||95% Confidence Interval|Mean
2577174|NCT02443688|Primary|Difference From Placebo in Absolute Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted (ppFEV1)|Difference from Placebo in absolute change from Baseline at Week 48 was assessed for FEV1 percent predicted.|Baseline, Week 48|Full Analysis Population - All subjects randomized to and receiving at least 1 dose of assigned treatment. The primary analysis was based upon the pooled results of the 100mg and 50mg doses.|||FEV1 percent predicted||95% Confidence Interval|Mean
2577175|NCT02443571|Secondary|Detection Rate, Sensitivity, Specificity, and Negative Predictive Value to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer|"Detection rate is the percentage of participants with positive finding in Fluciclovine 18F scan.~Sensitivity is the percentage of participants with positive finding in biopsy correctly identified as positive by Fluciclovine 18F scan.~Specificity is the percentage of participants with negative finding in biopsy correctly identified as negative by Fluciclovine 18F scan.~Negative Predictive Value is the percentage of participants with a negative Fluciclovine 18F scan who truly don't have positive finding in biopsy."|Up to 1 year post Fluciclovine 18F||||Percentage of participants||95% Confidence Interval|Number
2577176|NCT02443571|Secondary|Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer|"Detection rate is the percentage of participants with positive finding in Fluciclovine 18F scan.~Sensitivity is the percentage of participants with positive finding in biopsy correctly identified as positive by Fluciclovine 18F scan.~Specificity is the percentage of participants with negative finding in biopsy correctly identified as negative by Fluciclovine 18F scan.~Negative Predictive Value is the percentage of participants with a negative Fluciclovine 18F scan who truly don't have positive finding in biopsy."|Up to 1 year post Fluciclovine 18F||||Percentages||95% Confidence Interval|Number
2577177|NCT02443571|Primary|Positive Predictive Value of FACBC to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer|Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy.|Up to 1 year post Fluciclovine 18F||||Percentage of participants||95% Confidence Interval|Number
2577178|NCT02443571|Primary|Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer|Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy.|Up to 1 year post Fluciclovine 18F|"Standard of truth was histology. For the prostate/bed region standard TRUS/biopsy or MRI/TRUS fusion biopsy was used to establish truth while blinded to PET findings.~When feasible, clinically relevant 18F-fluciclovine positive extraprostatic areas underwent directed biopsy based on cognitive fusion of the PET/CT data with biopsy technique."|||Percentage of participants||95% Confidence Interval|Number
2577179|NCT02443571|Primary|Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events|Treatment-emergent Adverse Events and Treatment-Emergent Serious Adverse Events|Up to 35 days post Fluciclovine 18F|Patients who have received at least one dose of Fluciclovine 18F|||Participants|||Count of Participants
2577180|NCT02443402|Secondary|Number of Subject Requiring Surgical Re-Intervention|The number of subjects that require surgical re-intervention due to mediastinal exploration and post-operative hemorrhage.|Post-Surgery (Up to 10 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
2577181|NCT02443402|Secondary|Number of Subjects Requiring Re-intubation Within 24 Hours|The number of subjects requiring re-intubation with 24 after CABG.|Post-Surgery (Up to 24 Hours)|Participants that completed all study assessments.|||Participants|||Count of Participants
2577182|NCT02443402|Secondary|Number of Subjects Requiring Re-intubation|The number of subjects requiring re-intubation after CABG.|Post-Surgery (Up to 2 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
2577183|NCT02443402|Secondary|Number of Subjects Requiring the Use of Inotropes for Greater Than 24 Hours|The number of subjects requiring the use of inotropes for >24 hours post CABG.|Post-Surgery (Up to 2 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
2577184|NCT02443402|Secondary|Number of Participants With Infections Not Requiring Hospital Re-admission|Number of subjects with infections not requiring hospital re-admission within 30 days after hospital discharge.|Post-Hospital Discharge (Up to 30 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
2577185|NCT02443402|Secondary|Number of Participants With Emergency Room (ER) Visits|Number of subjects returning to the ER up to 30 days (all-cause) after hospital discharge.|Post-Hospital Discharge (Up to 30 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
2577186|NCT02443402|Secondary|Number of Participants Re-admitted to the Hospital Not Due to Wound Infections|Number of subjects readmitted to the hospital within 30 days for all causes excluding wound infection.|Post-Hospital Discharge (Up to 30 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
2577187|NCT02443402|Secondary|Number of Participants Re-admitted to the Hospital Due to Wound Infections|Number of subjects readmitted to the hospital within 30 days due to wound infection.|Post-Hospital Discharge (Up to 30 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
2577188|NCT02443402|Secondary|Length of Hospital Stay After Study Randomization|Number of days in the hospital after a participant is randomized to a study intervention.|Post-Randomization (Up to 9 days)|Participants that completed all study assessments.|||days||Inter-Quartile Range|Mean
2577189|NCT02443402|Secondary|Length of Stay: Intensive Care Unit (ICU)|Number of days in the ICU after coronary artery bypass graft surgery (CABG).|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||days||Inter-Quartile Range|Mean
2577190|NCT02443402|Secondary|Hospital Complication Rate|The total number of all complications experienced during hospitalization. Participants may experience more than one complication during hospitalization and these will be included in the hospital complication rate.|Duration of Hospitalization (Up to 30 days)|Participants that completed all study assessments.|||number of complications|||Number
2577191|NCT02443402|Secondary|Number of Participants With Cerebrovascular Events|Number of participants that experienced permanent stroke and reversible ischemic neurologic deficit events.|Post-Hospital Discharge (Up to 10 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
2577197|NCT02443402|Secondary|Number of Participants With Hyperglycemia After Transition From Intensive Care Unit (ICU)|Number of participants with blood glucose (BG) >180 after transition from ICU.|Post-Surgery (Up to 10 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
2577198|NCT02443402|Secondary|Number of Participants With Severe Hyperglycemic Events During Continuous Insulin Infusion (CII)|Number of participants with two consecutive blood glucose concentrations >180 mg/dL in ICU during CII.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
2577199|NCT02443402|Secondary|Total Insulin Therapy in the Intensive Care Unit (ICU)|Total amount of insulin glargine insulin (units) administered in the ICU per day.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||units per day||Standard Deviation|Mean
2577200|NCT02443402|Secondary|Mean Blood Glucose (BG) Concentration After Transition From Intensive Care Unit (ICU)|The blood glucose levels will be assessed throughout the day using a glucose meter after transition form the ICU. The normal BG range for someone with diabetes is 80-130 mg/dL.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||mg/dl||Standard Deviation|Mean
2577201|NCT02443402|Secondary|Mean Units Subcutaneous (SQ) Insulin Required|Mean number of supplemental insulin units (lispro or aspart) administered after receiving insulin glargine (SQ insulin).|Post-Surgery (Up to 10 Days)|Participants that completed all study assessments.|||units||Standard Deviation|Mean
2577202|NCT02443402|Secondary|Duration of Continuous Intravenous Insulin (CII)|Mean number of hours on continuous intravenous insulin (CII) after ICU discharge.|Post-Intensive Care Unit (ICU) Discharge (Up to 4 Days)|Participants that completed all study assessments.|||hours||Inter-Quartile Range|Mean
2577203|NCT02443402|Secondary|Mean Amount of Insulin Therapy in the Intensive Care Unit (ICU)|The mean number of insulin infusions given per day (unit/day) while subjects are in the ICU. The more insulin given, the more hyperglycemic events experienced.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||units per day||Standard Deviation|Mean
2577204|NCT02443402|Secondary|Mean Daily Intensive Care Unit (ICU) Blood Glucose (BG) Concentration|The blood glucose levels will be assessed throughout the day using a glucose meter. An average will be calculated. The normal BG range for someone with diabetes is 80-130 mg/dL.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||mg/dL||Standard Deviation|Mean
2577205|NCT02443402|Secondary|Need for Continuous Intravenous Insulin (CII) for Treatment of Hyperglycemia|Number of subjects with hyperglycemia (BG >180 mg/dL) who require CII in the ICU.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
2577206|NCT02443402|Primary|Number of Subjects With Persistent Hyperglycemia|Number of subjects with persistent hyperglycemia (2 consecutive fasting and/or premeal BG > 180 mg/dL, or with average daily BG >180 mg/dl) who require insulin glargine (rescue therapy) after discontinuation of continuous intravenous insulin (CII)|Post-Surgery (Up to 10 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
2577207|NCT02443402|Primary|Number of Participants With Stress Hyperglycemic Events in the Intensive Care Unit (ICU)|Number of participants who developed stress hyperglycemia (BG >180 mg/dl) during coronary artery bypass grafting (CABG) or after CABG requiring continuous IV insulin infusion (CII) while in the ICU.|Post-Surgery (Up to 4 Days)|Participants that completed all study assessments.|||Participants|||Count of Participants
2577208|NCT02443298|Secondary|Weekly Asthma Control Questionaire Score at Week 24|The score at week 24 is the average of the responses to the five ACQ5 questions for the week preceding the Week 24 visit. The ACQ5 asks patients to rate the severity of their asthma symptoms and the degree to which asthma affected their sleep and other daily activities. The scale for all five ACQ5 questions range from the best possible answer of 0 (No symptoms, None, Never) to the worst possible answer of 6 (very severe, unable to sleep, totally limited). The ACQ5 score can range from 0.0 (best) to 6.0 (worst).|24 weeks|Full Analysis Set (FAS): All randomized patients who received at least one dose of treatment. Ten patients excluded from the analysis due to missing data at week 24.|||Unit on Scale||Standard Error|Least Squares Mean
2577209|NCT02443298|Secondary|Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24|Post-bronchodilator forced expiratory volume in 1 second (FEV1) in-clinic change from baseline at week 24.|Baseline and 24 weeks|FAS: All randomized patients who received at least one dose of treatment. One patient not included in the analysis due to missing baseline value and one patient not included in the analysis due to missing on-treatment data. Number of patients with either baseline or on-treatment data at the respective week and does not require having both.|||Liter (L)||Standard Error|Least Squares Mean
2577210|NCT02443298|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) In-clinic Change From Baseline at Week 24|Trough forced expiratory volume in 1 second (FEV1) in-clinic change from baseline at week 24.|Baseline and 24 weeks|Full Analysis Set (FAS): All randomized patients who received at least one dose of treatment. One patient not included in the analysis due to missing baseline value. Number of patients with either baseline or on-treatment data at the respective week and does not require having both.|||Liter (L)||Standard Error|Least Squares Mean
2577211|NCT02443298|Secondary|Annualized Rate of Severe Asthma Exacerbation During the Planned 24-week Treatment Period|"Annualized rate of severe asthma exacerbation during the planned 24-week treatment period.~Severe asthma exacerbation was defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days for asthma. Additionally, for subjects on maintenance systemic corticosteroids, at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for three or more consecutive days was considered a severe asthma exacerbation.~Mean is Annualized rate."|24 weeks|Full Analysis Set (FAS): All randomized patients who received at least one dose of treatment.|||Events per patient year||Standard Error|Mean
2577212|NCT02443298|Secondary|Time to First Severe Asthma Exacerbation During the Planned 24 Week Treatment Period|Time to first severe asthma exacerbation during the planned 24 week treatment period. Severe asthma exacerbation was defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days for asthma. Additionally, for subjects on maintenance systemic corticosteroids, at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for three or more consecutive days was considered a severe asthma exacerbation.|24 weeks|Full Analysis Set (FAS): All randomized patients who received at least one dose of treatment. NA = not estimable due to an insufficient numbers of patient with an event|||Days||80% Confidence Interval|Median
2577213|NCT02443298|Secondary|Annualized Rate of Asthma Worsening During the Planned 24 Week Treatment Period|"Annualized rate of asthma worsening during the planned 24 week treatment period.~Asthma worsening was defined as the occurrence of any one of the following four criteria:~a) Decrease from baseline of ≥30% in morning peak expiratory flow (PEF) on at least 2 consecutive days. b) Increase from baseline of ≥50% and an increase of least 4 puffs in daily use of rescue medication for at least 2 consecutive days. c) Increase from baseline of ≥0.75 units in ACQ5. d) Severe asthma exacerbations defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days for asthma. Additionally, for subjects on maintenance systemic corticosteroids, at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for three or more consecutive days was considered a severe asthma exacerbation.~Mean is Annualized rate."|24 weeks|Full Analysis Set (FAS): All randomized patients who received at least one dose of treatment.|||Events per patient year||Standard Error|Mean
2577214|NCT02443298|Secondary|Time to First Asthma Worsening During the Planned 24 Week Treatment Period According to Alternative Definition|"Time to first asthma worsening during the planned 24 week treatment period according to alternative definition:~Asthma worsening was defined as the occurrence of any one of the following four criteria:~a) Decrease from baseline of ≥30% in morning peak expiratory flow (PEF) on at least 2 consecutive days. b) Increase from baseline of ≥50% and an increase of least 4 puffs in daily use of rescue medication for at least 2 consecutive days. c) Increase from baseline of ≥0.5 units in ACQ5. d) Severe asthma exacerbations defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days for asthma. Additionally, for subjects on maintenance systemic corticosteroids, at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for three or more consecutive days was considered a severe asthma exacerbation."|24 weeks|Full Analysis Set (FAS): All randomized patients who received at least one dose of treatment.|||Days||80% Confidence Interval|Median
2577215|NCT02443298|Primary|Time to First Asthma Worsening During the Planned 24 Week Treatment Period|"Time to first asthma worsening during the planned 24 week treatment period:~Asthma worsening was defined as the occurrence of any one of the following four criteria:~a) Decrease from baseline of ≥30% in morning peak expiratory flow (PEF) on at least 2 consecutive days. b) Increase from baseline of ≥50% and an increase of least 4 puffs in daily use of rescue medication for at least 2 consecutive days. c) Increase from baseline of ≥0.75 units in ACQ5. d) Severe asthma exacerbations defined as initiation of systemic corticosteroids (prednisone or equivalent) for 3 or more consecutive days for asthma. Additionally, for subjects on maintenance systemic corticosteroids, at least doubling of the maintenance dose resulting in a total daily dose of ≥ 20 mg for three or more consecutive days was considered a severe asthma exacerbation."|24 weeks|Full Analysis Set (FAS): All randomized patients who received at least one dose of treatment.|||Days||80% Confidence Interval|Median
2577216|NCT02443103|Secondary|Treatment Related Adverse Events|Number of unique patients who had a treatment related (possible, probable or definite) adverse events.|Up to 1 year|All patients enrolled and received treatment.|||Participants|||Count of Participants
2577217|NCT02443103|Primary|Bone Turnover Markers-bone Formation and Bone Resorption|Number of patients who had blood specimens taken to collect and evaluate markers of bone formation and bone resorption. Note - due to poor accrual and early closure, bone marker data was not collected.|Day 0, Week 8, Week 12|All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit with bone marker information available.||||||
2577218|NCT02442856|Other Pre-specified|Linear Relationship Between Rate of Regulation Measured Using TCD and Optics|Linear relationship between Rate of Regulation measured using TCD and Optics, expressed as slope of linear fit|1.5 hours||||slope|||Number
2577219|NCT02442856|Primary|dCA Measurement During Acute Changes in Mean Arterial Pressure, Optical|Rate of Regulation, measured using diffuse correlation spectroscopy. Rate of regulation (ROR) is calculated as follows: ROR = (change in relative cerebrovascular resistance / change in time) / maximum fractional decrease in blood pressure due to thigh cuff deflation.|1.5 hours|21 subjects in the study, but hemodynamic monitoring was only possible in 18. 1 subject did not tolerate, and data acquisition was unsuccessful in 2. In 3 subjects, the pressure algorithm to isolate CBF was unsuccessful. In 4 subjects, BP did not decrease following cuff deflation due to technical issues leaving 11 subjects in the final analysis|||per second||95% Confidence Interval|Number
2577220|NCT02442856|Primary|dCA Measurement During Acute Changes in Mean Arterial Pressure, TCD|Rate of Regulation, measured using transcranial doppler. Rate of regulation (ROR) is calculated as follows: ROR = (change in relative cerebrovascular resistance / change in time) / maximum fractional decrease in blood pressure due to thigh cuff deflation.|1.5 hours|21 subjects consented, hemodynamic monitoring possible in 18. 1 subject did not tolerate,data acquisition was unsuccessful in 2. In 3 subjects, the pressure algorithm to isolate cerebral blood flow(CBF) was unsuccessful. In 4 subjects, BP did not decrease following cuff deflation due to technical issues leaving 11 subjects in the final analysis|||per second||95% Confidence Interval|Number
2577221|NCT02442830|Secondary|Number of Participants With Localization of Bleeding by the End of Admission|This measurement counts the number of participants with a bleeding source localized by the end of admission.|Patient's will be assessed for the duration of their hospital stay and for thirty days afterwards.||||Participants|||Count of Participants
2577222|NCT02442830|Primary|Time to Localization of Bleeding|Time to localization of bleeding refers to the time after a patient is admitted to the emergency room and a bleeding source is localized. We defined localization of bleeding as endoscopic visualization of stigmata of recent hemorrhage.|Enrollment to localization of bleeding as measured in hours, up to 720 hours, whichever is sooner.||||hours||Inter-Quartile Range|Median
2577223|NCT02442804|Secondary|Change From Baseline State-Trait Anxiety Inventory - Trait Score|"The State-Trait Anxiety Inventory (STAI) is a self-report inventory of anxiety symptoms. The test consists of two parts: 20 questions that assess anxiety level at the time of the examination (i.e., state) and 20 questions that assess the examinee's general level of anxiety (i.e., trait). Items include feeling at ease, feeling upset, feeling self-confident, feeling confused, feeling like a failure, feeling rested, and having disturbing thoughts, among others. Examinees endorse 1 of 4 options on a likert scale, from not at all to very much so. Each of the scales (state and trait) ranges from 0 to 80. Higher score indicates more anxiety symptoms."|Baseline and Day 9||||raw score||Standard Deviation|Mean
2581471|NCT02392208|Primary|Vss of Telavancin|Volume of distribution of telavancin at steady state|At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48||||mL/kg||Standard Deviation|Mean
2577224|NCT02442804|Secondary|Change From Baseline State-Trait Anxiety Inventory - State Score|"The State-Trait Anxiety Inventory (STAI) is a self-report inventory of anxiety symptoms. The test consists of two parts: 20 questions that assess anxiety level at the time of the examination (i.e., state) and 20 questions that assess the examinee's general level of anxiety (i.e., trait). Items include feeling at ease, feeling upset, feeling self-confident, feeling confused, feeling like a failure, feeling rested, and having disturbing thoughts, among others. Examinees endorse 1 of 4 options on a likert scale, from not at all to very much so. Each of the scales (state and trait) ranges from 0 to 80. Higher score indicates more anxiety symptoms."|Baseline and Day 9||||raw score||Standard Deviation|Mean
2577225|NCT02442804|Secondary|Change From Baseline Beck Depression Inventory - II (BDI-II) Score|The Beck Depression Inventory - Second Edition (BDI-II) is a widely used self-report questionnaire of depressive symptoms. The examinee is asked to respond to 21 items by endorsing whether or not they experience symptoms of sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentrating difficulty, tiredness or fatigue, and loss of interest in sex. Examinees can also describe the degree of severity of each symptom, as each item ranges from 0-3. The scorer adds the scores for each item to attain a total score, which is interpreted according to the following guidelines: 0-13 = minimal depression, 14-19 = mild depression, 20-28 = moderate depression, 29-63 = severe depression|Baseline and Day 9||||raw score||Standard Deviation|Mean
2577226|NCT02442804|Secondary|Change From Baseline Animals Fluency Score|The Animal Fluency task involves providing the examinee a category prompt. For example, the examiner asks the examinee to name as many animals as he or she can in 1 minute. The total number of acceptable words is tallied for a total score (ranging from 0 on up). Higher scores indicate better performance.|Baseline and Day 9||||number of acceptable words (animals)||Standard Deviation|Mean
2577227|NCT02442804|Secondary|Change From Baseline Trail-making Test Part B Score|The Trail-making Test Part B consists of circles with either numbers (1 - 13) or letters (A - L) in them; as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). Results for both TMT A and B are reported as the number of seconds required to complete the task (ranges from 0 to 300; discontinued at 300 seconds); therefore, higher scores reveal greater impairment.|Baseline and Day 9||||seconds||Standard Deviation|Mean
2577228|NCT02442804|Secondary|Change From Baseline Line Bisection Test Score|The Line Bisection Test consists of 20 horizontal lines of varying length and proximity to the center of a sheet of paper (i.e., some are closer to the left or right sides of the page). The examinee is asked to place a mark to bisect each line. The scorer measures the degree of deviation from the center of each line (in cm) and attains the absolute value of the average percentage of deviation across all 20 lines. The scorer also attains the dominant direction of deviation (i.e., whether the examinee misses more to the left or to the right on average across the 20 lines). The value of the largest deviation is imputed for any omissions. Percentage ranges from 0 on up. Higher percentage of deviation indicates worse performance.|Baseline and Day 9||||percentage of deviation from center||Standard Deviation|Mean
2577229|NCT02442804|Secondary|Change From Baseline Controlled Oral Word Association Test Score|The Controlled Oral Word Association Test (COWAT) is a measure of controlled verbal fluency that involves the examinee naming as many words that begin with a certain letter of the alphabet as he or she can in 1 minute. There are a few rules (i.e., no proper nouns and no words that have the same meaning and only differ by its suffix) and the task is repeated twice more with different letters each time. The scorer tallies the total acceptable words from all 3 trials into one total score (ranges from 0 on up). Higher total score indicates better performance.|Baseline and Day 9||||number of acceptable words||Standard Deviation|Mean
2577230|NCT02442804|Secondary|Change From Baseline Brief Test of Attention Score|On the Brief Test of Attention (BTA), the examinee listens to a string of numbers and letters and must mentally tally (without the use of their fingers) how many numbers are in a particular trial. They do this for 10 trials and then are given 10 additional trials with the task of tallying how many letters they hear. The task increases in difficulty as the trials progress, and the entire test takes 5-10 minutes to complete. The scorer adds the number of trials correct from all 20 trials to attain a total score (ranges from 0 to 20). Higher scores indicate better performance.|Baseline and Day 9||||raw score||Standard Deviation|Mean
2577231|NCT02442804|Secondary|Change From Baseline Trail-making Test Part A Score|The Trail-making Test consists of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. Results for the test are reported as the number of seconds required to complete the task (ranges from 0 to 300; discontinued at 300 seconds); therefore, higher scores reveal greater impairment.|Baseline and Day 9||||seconds||Standard Deviation|Mean
2577232|NCT02442804|Secondary|Change From Baseline Functional Independence Measure (FIM) Score|Functional Independence Measure (FIM) Score consists of eighteen sub-measures under the following 6 categories: Self-Care (eating, grooming, bathing, dressing upper body, dressing lower body, toileting), Sphincter Control (bladder control, bowel control), Transfers (bed/chair/wheelchair transfer, toilet transfer, tub/shower transfer), Locomotion (walk/wheelchair, stairs), Communication (comprehension, expression), and Social Cognition (social interaction, memory, problem solving). Scores for each sub-measure range from 1 (total assistance) to 7 (complete independence), and the 18 scores are summed to obtain the FIM score. Higher scores indicate better performance.|Baseline and Day 9||||raw score||Standard Deviation|Mean
2577233|NCT02442804|Secondary|Change From Baseline Mini-Mental State Examination - 2nd Edition Score|The MMSE-2 is a brief (about 10 minutes) screening tool that touches upon orientation to time and place, recall, attention/calculation, naming, repetition, comprehension, reading, writing, and drawing, with all the scores from these domains cumulating to a maximum of 30 points (minimum = 0). Higher score indicates better performance.|Baseline and Day 9||||raw score||Standard Deviation|Mean
2577256|NCT02442687|Primary|Analysis of MRI-PDFF Change From Baseline to Week 24 (Per Protocol Population)||Baseline to week 24|The per protocol population included only those patients with non-missing baseline (ie. screening) and the specified visit are included. If missing, the last valid measurement on or prior to the first date administration of study medication is used as baseline.|||percentage of fat||95% Confidence Interval|Least Squares Mean
2577234|NCT02442804|Primary|Change From Baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) provides both a total scale score and scores for 5 different cognitive domains. It is relatively brief (approximately 20 minutes total) and has alternate forms. Specifically, the test measures immediate memory (with list learning and story memory), visuospatial/constructional ability (with figure copy and line orientation), language (with picture naming and semantic fluency), attention (with digit span and coding), and delayed memory (with list recall, list recognition, story recall, and figure recall). Scores from all subtests are aggregated into a total composite score (manual provides conversion procedure). RBANS data were age-normed based on the sample described in the manual (Randolph, 2012) and were analyzed as index scores (also referred to as standard scores), which have a mean of 100 and a standard deviation of 15. Higher scores on each sub measure and index indicate better performance.|Baseline and Day 9||||standard score change||Standard Deviation|Mean
2577235|NCT02442700|Secondary|Safety of Pitavastatin in HIV-infected Patients|"Safety clinical was defined by FDA; grade 1 mild symptoms; grade 2 moderate symptoms with limiting age-appropriate IADL; grade 3 severe symptoms with limiting self-care ADL, But not immediately life-threatening; grade 4 life-threatening consequences; and grade 5 death related to adverse event.~Safety laboratory evaluation was determined safe if AST, ALT, and/or CPK level was not increased significantly comparing pitavastatin to placebo."|12 weeks||||U/L||95% Confidence Interval|Mean
2577236|NCT02442700|Primary|Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir|Efficacy was measured by level of TC, TG, LDL, and HDL that decreased after pitavastatin treatment. Pitavastatin was considered efficient when it could decrease TC, TG, LDL, or HDL significantly compared to placebo.|12 weeks||||mg/dL||95% Confidence Interval|Mean
2577237|NCT02442687|Secondary|Half-life||pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, and 24 hours|PK Substudy Population|||h||Standard Deviation|Mean
2577238|NCT02442687|Secondary|Area Under Concentration-time (AUC)||pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, and 24 hours|PK Substudy Population|||h*ng/mL||Standard Deviation|Mean
2577239|NCT02442687|Secondary|Minimum Observed Concentration (Cmin)||pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, and 24 hours|PK Substudy Population|||ng/mL||Standard Deviation|Mean
2577240|NCT02442687|Secondary|Maximum Observed Concentrations (Cmax)||pre-dose and at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12, and 24 hours|PK Substudy Population|||ng/mL||Standard Deviation|Mean
2577241|NCT02442687|Secondary|Number of Subjects With ALT in Normal Range at Week 24|Normal range is <40 U/L|Week 24|Number of subjects with an ALT result at the specified visit|||Participants|||Count of Participants
2577242|NCT02442687|Secondary|Mean Serum Gamma-glutamyl Transpeptidase (GGT)||weeks 4, 8, 12, 16, 20, and 24|Number of subjects with a result at baseline and the specified visit. Baseline is defined as the measurement at Day 1.|||U/L||Standard Deviation|Mean
2577243|NCT02442687|Secondary|Mean Serum Alanine Aminotransferase (ALT)||weeks 4, 8, 12, 16, 20, and 24|Number of subjects with a result at baseline and the specified visit. Baseline is defined as the measurement at Day 1.|||U/L||Standard Deviation|Mean
2577244|NCT02442687|Secondary|Mean Serum Aspartate Aminotransferase (AST)||weeks 4, 8, 12, 16, 20, and 24|Number of subjects with a result at baseline and the specified visit. Baseline is defined as the measurement at Day 1.|||U/L||Standard Deviation|Mean
2577245|NCT02442687|Secondary|Percent Change in High Density Lipoprotein (HDL)||Baseline, week 24|Only patients with non-missing baseline and the specified visit are included.|||percent change||95% Confidence Interval|Least Squares Mean
2577246|NCT02442687|Secondary|Percent Change in Low Density Lipoprotein (LDL) Cholesterol||Baseline, week 24|Only patients with non-missing baseline and the specified visit are included.|||percent change||95% Confidence Interval|Least Squares Mean
2577247|NCT02442687|Secondary|Percent Change in Triglycerides||Baseline, week 24|Only patients with non-missing baseline and the specified visit are included.|||percent change||95% Confidence Interval|Least Squares Mean
2577248|NCT02442687|Secondary|Percent Change in Cholesterol||Baseline, week 24||||percent change||95% Confidence Interval|Least Squares Mean
2577249|NCT02442687|Secondary|Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)|HOMA-IR was calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. Optimal Range: 1.0 (0.5-1.4). Lower values represent a better outcome.|Baseline, week 24|Only patients with non-missing baseline and the specified visit are included.|||HOMA-IR index||95% Confidence Interval|Least Squares Mean
2577250|NCT02442687|Secondary|Change in Hemoglobin A1C||Baseline, week 24|Only patients with non-missing baseline and the specified visit are included|||percentage of HbA1C||95% Confidence Interval|Least Squares Mean
2577251|NCT02442687|Secondary|Change in BMI (Body Mass Index)||Baseline, week 24|Only patients with non-missing baseline and the specified visit are included.|||kg/m^2||95% Confidence Interval|Least Squares Mean
2577252|NCT02442687|Secondary|Time to Remission (in Weeks)|Time to remission is the time in weeks from randomization to liver function remission, defined as two consecutive ALT values within normal range (<40 U/L) during the treatment period.|24 weeks|No subjects reached remission; analysis not performed.||||||
2577253|NCT02442687|Secondary|Analysis of ALT Change From Baseline to Week 12 (Per Protocol Population)||Baseline to week 12|The per protocol population included only those patients with non-missing baseline (ie. screening) and the specified visit are included. If missing, the last valid measurement on or prior to the first date administration of study medication is used as baseline.|||U/L||95% Confidence Interval|Least Squares Mean
2577254|NCT02442687|Secondary|Analysis of ALT Change From Baseline to Week 24 (Per Protocol Population)||Baseline to week 24|The per protocol population included only those patients with non-missing baseline (ie. screening) and the specified visit are included. If missing, the last valid measurement on or prior to the first date administration of study medication is used as baseline.|||U/L||95% Confidence Interval|Least Squares Mean
2577255|NCT02442687|Primary|Analysis of MRI-PDFF Change From Baseline to Week 12 (Per Protocol Population)||Baseline to Week 12|The per protocol population included only those patients with non-missing baseline (ie. screening) and the specified visit are included. If missing, the last valid measurement on or prior to the first date administration of study medication is used as baseline.|||percentage||95% Confidence Interval|Least Squares Mean
2577257|NCT02442349|Secondary|Disease Control Rate (DCR) According to RECIST 1.1|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. DCR is the percentage of patients with best response of CR, PR or SD (according to independent review), prior to progression (PD) or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from time first dose until date of progression, for an average of approximately 12 months. Results are based on the data cut off of 04 March 2016 (about 18 weeks after LSFD).|All patients who received at least 1 dose of study treatment and had measurable disease at baseline by blinded independent central review (BICR) of baseline imaging data.|||% of participants||95% Confidence Interval|Number
2577258|NCT02442349|Primary|Objective Response Rate (ORR) According to RECIST 1.1|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from time of first dose until objective disease progression, for an average of approximately 12 months. Results are based on the data cut off of 04 March 2016 (about 18 weeks after LSFD).|All patients who received at least 1 dose of study treatment and had measurable disease at baseline by blinded independent central review (BICR) of baseline imaging data.|||% of participants||95% Confidence Interval|Number
2577259|NCT02442310|Secondary|Number of Subjects With Adverse Events (AEs)|Number of subjects with AEs, by frequency, severity, time to onset, duration, and relatedness to study product. AEs will include clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations, and laboratory tests.|Throughout the trial, from the time of the first dose until the last study visit (Day 30 or early termination)|The safety population included all subjects who received at least one of the investigational products under study.|||participants|||Number
2577260|NCT02442310|Primary|AUC0-∞for Serum Deferiprone and Deferiprone 3-O-glucuronide|Area under the serum concentration time curve extrapolated to infinity. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|24-hour interval|The pharmacokinetics population included all subjects who provided evaluable data for at least one of the comparisons of interest|||ug*h/mL||Standard Deviation|Mean
2577261|NCT02442310|Primary|Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Time to maximum observed serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|24-hour interval|The pharmacokinetics population included all subjects who provided evaluable data for at least one of the comparisons of interest|||Hour||Standard Deviation|Mean
2577262|NCT02442310|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Maximum measured serum concentration. Blood samples will be collected pre-dose and over a 24-hour interval post-dose|24-hour interval|The pharmacokinetics population included all subjects who provided evaluable data for at least one of the comparisons of interest|||μg/mL||Standard Deviation|Mean
2577263|NCT02442284|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Among Participants With Ongoing Psychiatric Disorders|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backwards imputation were imputed as nonresponders.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population) and with ongoing psychiatric disorders.|||percentage of participants||95% Confidence Interval|Number
2577264|NCT02442284|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
2577265|NCT02442284|Secondary|Percentage of Participants With Virologic Failure During Treatment|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment.|up to 12 weeks (for 12-week treatment group) or up to 24 weeks (for 24-week treatment group|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2577266|NCT02442284|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backwards imputation were imputed as nonresponders.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2577276|NCT02442206|Secondary|Change in Left and Right Ventricular End-systolic Volume|Right ventricular end-systolic volume (RV-ESV) and left ventricular end-systolic volume (LV-ESV) is a measurement of the volume of blood in the heart's right and left ventricular chamber, respectively, at the end of the heart's contraction and will be determined as measured by MRI.|Baseline, week 2|Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment|||ML||Standard Deviation|Mean
2577317|NCT02441218|Primary|Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure.|Number of patients having experienced the Primary Composite Endpoint.|All over the study (up to 42 months).||||participants|||Number
2577267|NCT02442271|Secondary|(SF-36v2) Mental Component Summary (MCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug|The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a PCS score and a MCS score. Scores SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening. If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain. In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing. The SF-36v2 MCS and PCS scores were not computed if any domain was missing.|Day 1 (Baseline), 12 weeks after the last actual dose of the study drug|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
2577268|NCT02442271|Secondary|Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug|The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening. If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain. In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing. The SF-36v2 MCS and PCS scores were not computed if any domain|Day 1 (Baseline), 12 weeks after the last actual dose of the study drug|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
2577269|NCT02442271|Secondary|Hepatitis C Virus Patient-Reported Outcomes Instrument (HCV-PRO) Total Score: Change From Baseline to 12 Weeks After the Last Dose of Study Drug|The HCV-PRO has been developed to capture the function and well-being impact of HCV conditions and treatment and contains 16 items important to HCV-infected patients; items were totaled to a summary score. Scores range from 0 to 100. A higher HCV-PRO score indicates a better state of health and a decrease from baseline represents worsening. If a participant answered at least 12 of the 16 items, the missing items were imputed with the mean score of the answered items; if a participant did not answer at least 12 of the items, the total score was considered missing.|Day 1 (Baseline), 12 weeks after the last actual dose of the study drug|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
2577270|NCT02442271|Secondary|Percentage of Participants With SVR12 by Participant Eligibility for Treatment With Interferon (IFN) at Screening|SVR12 was defined as HCV RNA level <LLOQ 12 weeks after the last dose of study drug. Data are presented by prior HCV treatment experience. Data are provided by participants' eligibility for treatment with IFN at screening. Participants with missing data were counted as failures.|12 weeks after the last actual dose of study drug|All participants in the ITT population.|||percentage of participants||95% Confidence Interval|Number
2577271|NCT02442271|Secondary|Percentage of Participants With SVR12 by Participant Prior HCV Treatment Experience|SVR12 was defined as HCV RNA level <LLOQ 12 weeks after the last dose of study drug. Data are presented by prior HCV treatment experience. Data are provided by participants' prior HCV treatment experience at screening. Participants with missing data were counted as failures.|12 weeks after the last actual dose of study drug|All participants in the ITT population.|||percentage of participants||95% Confidence Interval|Number
2577272|NCT02442271|Secondary|Percentage of Participants With SVR12 by Fibrosis Stage|SVR12 was defined as plasma HCV RNA level <LLOQ]12 weeks after the last dose of study drug. The percentage of participants achieving SVR12 by fibrosis stage (F3 and F4) are presented. Participants with missing data were counted as failures.|12 weeks after the last actual dose of study drug|All participants in the ITT population.|||percentage of participants||95% Confidence Interval|Number
2577273|NCT02442271|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data were counted as failures.|12 weeks after the last actual dose of study drug|Intent-to-treat population: all participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2577274|NCT02442206|Secondary|Cardiac Output at Each Time-point, Left and Right Ventricular Cardiac Output (LVCO and RVCO)|Cardiac output is calculated as the heart rate multiplied by the stroke volume (= difference between ventricular enddiastolic volume and endsystolic volume) that will be determined as measured by MRI.|week 2|Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment|||Liter/min||Standard Deviation|Mean
2577275|NCT02442206|Secondary|Change in Right Ventricular Enddiastolic Volume|Right ventricular end-diastolic volume is a measurement of the volume of blood in the heart's right ventricular chamber at the end of the chamber's filling with blood and will be determined as measured by MRI.|Baseline, week 2|Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment|||ML||Standard Deviation|Mean
2577277|NCT02442206|Secondary|Change in Right Ventricular (RV) and Left Ventricular (LV) Ejection Fraction (EF)|Right and left ventricular ejection fraction is the fraction of blood (in percent) pumped out of the heart's left and right ventricular chamber, respectively, with each heart beat and will be determined as measured by MRI.|Baseline, week 2|Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment|||Percentage||Standard Deviation|Mean
2577278|NCT02442206|Secondary|Change in Functional Residual Capacity (FRC)|Functional Residual Capacity (FRC) will be calculated as the mean of three reproducible values as measured by body plethymography according to internationally accepted standards.|Baseline, week 2|Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment|||Liters||Standard Deviation|Mean
2577279|NCT02442206|Secondary|Change in Specific Airway Resistance (sRaw)|Specific Airway Resistance (sRaw) will be documented as effective resistance (sReff) calculated as the median of five acceptable measurements. Values will be measured by body plethymography according to internationally accepted standards.|Baseline, week 2|Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment|||kPa*s/L||Standard Deviation|Mean
2577280|NCT02442206|Secondary|Change in Residual Volume (RVol)|Residual Volume (RVol) will be calculated from the value of Total Lung Capacity (TLC) minus the highest value of the Slow Vital Capacity, both measured by body plethymography according to internationally accepted standards.|Baseline, week 2|Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment|||Liters||Standard Deviation|Mean
2577281|NCT02442206|Secondary|Change in Total Lung Capacity (TLC)|Total Lung Capacity (TLC) will be calculated from the mean Functional Residual Capacity (FRC) plus the highest value of the Inspiratory Capacity, both measured by body plethymography according to internationally accepted standards.|Baseline, week 2|Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment|||Liters||Standard Deviation|Mean
2577282|NCT02442206|Secondary|Change in Inspiratory Capacity (IC) at Each Time-point|Inspiratory capacity (IC) was defined as the mean of the maximum IC over 3 values measured by bodyplethysmography according to internationally accepted standards.|Baseline, week 2|Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment|||Liters||Standard Deviation|Mean
2577283|NCT02442206|Secondary|Change in Forced Vital Capacity (FVC).|Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry.|Baseline, week 2|Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment|||Liter||Standard Deviation|Mean
2577284|NCT02442206|Secondary|Change in Forced Expiratory Volume in One Second (FEV1).|Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by spirometry.|Baseline, week 2|Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment|||Liter||Standard Deviation|Mean
2577285|NCT02442206|Primary|Change in Left Ventricular End-diastolic Volume (LVEDV)|Left ventricular enddiastolic volume (LVEDV) is a measurement of the volume of blood in the heart's left ventricular chamber at the end of the chamber's filling with blood and will be determined as measured by MRI.|Baseline, week 2|Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid LV EDV value at both baseline and post-baseline in a period were included|||ML||Standard Deviation|Mean
2577286|NCT02441946|Secondary|PK: Apparent Volume of Distribution of Abemaciclib|Abemaciclib apparent volume of distribution was calculated by population NONMEM using all available data spanning cycles 1 and cycles 3-5.|Cycle(C)1, Day(D)1: 2 to 4 Hours (Hrs) Postdose; C1D14: 4 Hrs Postdose, 7 Hrs Postdose; C3D1: Predose, 3 Hrs Postdose, C4D1 & C5D1, Predose, C5D28: Predose, 3 Hrs Postdose|All randomized participants who received at least one dose of abemaciclib across cycles 1 and cycles 3-5. The results are summarized by the original randomized arms of cycle 1.|||Liters (L)||Geometric Coefficient of Variation|Geometric Mean
2577287|NCT02441946|Secondary|Pharmacokinetics (PK): Apparent Clearance of Abemaciclib|Abemaciclib apparent clearance (CL/F) was calculated by population nonlinear mixed effects modeling (NONMEM) using all available data spanning cycles 1 and cycles 3-5.|Cycle(C)1, Day(D)1: 2 to 4 Hours (Hrs) Postdose; C1D14: 4 Hrs Postdose, 7 Hrs Postdose; C3D1: Predose, 3 Hrs Postdose, C4D1 & C5D1, Predose, C5D28: Predose, 3 Hrs Postdose|All randomized participants who received at least one dose of abemaciclib across cycles 1 and cycles 3-5. The results are summarized by the original randomized arms of cycle 1.|||Liters/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2577288|NCT02441946|Secondary|Change From Baseline to Week 2 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)|EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, emotional, cognitive, or social functioning), global health status and symptom scales of fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.|Baseline, 2 Weeks|All randomized participants who received at least one dose of study drug and had evaluable data for EORTC QLQ.|||units on a scale||Standard Deviation|Mean
2577311|NCT02441218|Secondary|Hospitalisation for Cardiovascular Reason||From the date of randomisation to the first documented hospitalisation, up to 42 months||||participants|||Number
2581472|NCT02392208|Primary|Cmax of Telavancin|Peak concentration of telavancin|At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48||||mcg/mL||Standard Deviation|Mean
2577289|NCT02441946|Secondary|Percentage of Participants With Complete Radiologic Response or Partial Radiological Response: Radiological Response|Radiological response is the percentage of participants with CR or, PR according to RECIST v.1.1. A responder is defined as any participant who exhibits a CR or PR. CR is the disappearance of all target lesions. PR is a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. PD is 20% increase in the sum of diameters of target lesions taking as reference the smallest sum and the appearance of 1 or more new lesions.|From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks)|All participants who received combination treatment post cycle 1. Radiological/surgery assessments occurred at the start of treatment and at the end of the treatment.|||percentage of participants|||Number
2577290|NCT02441946|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR): Clinical Objective Response|Clinical objective response is defined as the percentage of participants with the best overall response rate (ORR) with a best OR of CR or PR, according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1. ORR is recorded from the start of the study treatment until the earliest of objective progression or start of new anticancer therapy. A responder depends on target and non-target disease and the appearance of new lesions. CR is defined as the disappearance of all non-target lesions. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. All lymph nodes are non-pathological or normal in size (<10mm short axis). Progressive disease (PD) is a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, a relative increase of 20%, the sum must also demonstrate an absolute increase of 5 mm.|From Start of Treatment to Objective Progression or Start of New Anticancer Therapy (Up to 16 Weeks)|All participants who received combination treatment post cycle 1. Radiological/surgery assessments occurred at the start of treatment and at the end of the treatment.|||percentage of participants|||Number
2577291|NCT02441946|Secondary|Percentage of Participants With Pathologic Complete Response (pCR)|pCR is defined as absence of invasive cancer in the breast and sampled regional lymph nodes.|From Start of Treatment Up to 16 Weeks|All participants who received combination treatment post cycle 1 and had evaluable pCR data. Radiological/surgery assessments occurred at the start of treatment and at the end of the treatment.|||percentage of participants|||Number
2577292|NCT02441946|Primary|Percent Change From Baseline to 2 Weeks in Ki67 Expression|Tumor tissue collected through a core biopsy at baseline and at the end of cycle 1 was used to determine Ki67 expression. Ki67 expression is defined as the percent of cells staining positive by validated central assay.|Baseline, 2 Weeks|All randomized participants who received at least one dose of study drug and a valid baseline Ki67 measurement of at least 5% and a valid 2-week measurement of any magnitude.|||Percent Change||90% Confidence Interval|Geometric Mean
2577293|NCT02441517|Secondary|Number of Participants With Adverse Events|Safety was assessed by adverse events (AEs), which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE (SAE) was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. Disease progression was not to be reported as an AE, and clinical signs and symptoms due to disease progression were collected as AEs.|From first dose of study drug up to date of last evaluation of 15 March 2017 (approximately 17 months)|The analysis population was the SAF.|||Participants|||Count of Participants
2577294|NCT02441517|Secondary|Time to First Use of a Subsequent Antineoplastic Therapy|Time to start of other antineoplastic therapy was defined as the date of the first systemic antineoplastic therapy minus the date of the first dose of study drug + 1.|From first dose of study drug up to date of last evaluation of 15 March 2017 (approximately 17 months)|The analysis population was the FAS. Only participants who underwent subsequent antineoplastic therapy were included in the analysis.|||days||95% Confidence Interval|Median
2577295|NCT02441517|Secondary|Number of Participants With Objective Response|Objective response was defined as the best overall response of complete response (CR) or partial response (PR) per RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|From first dose of study drug up to date of last evaluation of 15 March 2017 (approximately 17 months)|The analysis population was the FAS. Only participants with measurable disease at baseline were included in the analysis.|||Participants|||Count of Participants
2577296|NCT02441517|Secondary|Number of Participants With PSA Response|PSA response was defined for the three following categories: PSA30 response: a maximum decline of ≥ 30% from baseline at any post baseline time point; PSA50 response: a maximum decline of ≥ 50% from baseline at any post baseline time point; PSA90 response: a maximum decline of ≥ 90% from baseline at any post baseline time point.|From baseline up to date of last evaluation of 15 March 2017 (approximately 17 months)|The analysis population was the FAS. Only participants with at least 1 postbaseline PSA measure were included in the analysis.|||Participants|||Number
2577297|NCT02441517|Secondary|Time to Prostate-Specific Antigen (PSA) Progression|The time to PSA progression was defined as the PSA progression date minus the date of first dose + 1. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir (lowest PSA value observed postbaseline or the baseline value for participants who did not have a decline in PSA postbaseline values) in PSA levels, and which was confirmed by a second consecutive value obtained at least 3 or more weeks later (i.e., a confirmed rising trend) (PCWG2 criteria). The date of PSA progression was the first date the PSA progression was observed. Time to PSA progression was estimated via Kaplan-Meier methodology with censoring defined by the time of the last available PSA measure.|From first dose of study drug up to date of last evaluation of 15 March 2017 (approximately 17 months)|The analysis population was the FAS.|||days||95% Confidence Interval|Median
2577298|NCT02441517|Secondary|Overall Survival|Overall survival (OS) was defined as the date of death due to any cause minus the date of first dose + 1.|From first dose of study drug up to date of last evaluation of 15 March 2017 (approximately 17 months)|The analysis population was the FAS. Only participants with an overall survival event were included in the analysis.||||||
2577299|NCT02441517|Primary|Radiographic Progression Free Survival (rPFS)|Radiographic PFS (rPFS) was defined as the time from first dose to the radiographic disease progression (PD), or death on study, whichever occurred first. Radiological PD was defined by either soft tissue tumor progression defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, or bone progression defined by the Prostate Cancer Clinical Trials Working Group 2 (PCWG2). Bone progression per PCWG2 was defined as a minimum of two new lesions. Progression on bone scans at time points before or at week 9 required a confirmatory scan performed six or more weeks later, where it should have demonstrated at least 2 additional new lesions (PCWG2) compared to the week 9 scan. rPFS was analyzed using Kaplan-Meier methodology to account for censored outcomes (i.e., no observation of rPFS event within the study follow-up period).|From first dose of study drug up to date of last evaluation of 15 March 2017 (approximately 17 months)|The analysis population was the full analysis set (FAS), which consisted of all participants who are enrolled in the study, received at least one dose of study drug, and have at least one post baseline evaluation.|||days||95% Confidence Interval|Median
2577300|NCT02441309|Secondary|Biological Response (Systemic Levels of Mifamurtide Activated Cytokines).|Biological response based on systemic levels of mifamurtide activated cytokines.|During screening, and weeks 1, 4, 6 and 7. Then every 3 weeks during treatment.|Insufficient number of participants for events for both primary and secondary objectives. The study stopped prematurely because of poor recruitment, meaning that no complete statistical analysis was possible as there were insufficient events and data were not collected.||||||
2577301|NCT02441309|Secondary|Progression Free Survival|"Time from randomisation for deemed non-resectable groups, or time from registration for deemed resectable group to first event, where an event is Progressive Disease as (defined by RECIST criterion v1.1) or death due to any cause. Patients who have not had an event will be censored at their last follow-up date. Patients lost to follow-up without an event will be censored at the date of their last consultation.~Progressive disease according to RECIST v1.1 is defined as a >=20% increase in the sum of long diameters of target lesions, OR progression of non-target lesions, OR evidence of new lesions."|Up to 42 weeks|Intention to treat|||months||95% Confidence Interval|Median
2577302|NCT02441309|Secondary|Disease Specific Overall Survival|Median time from death attributed to the disease. Censored at last known time alive or death from other causes.|Up to 42 weeks|Intention to treat|||months||95% Confidence Interval|Median
2577303|NCT02441309|Secondary|Number of Patients Experiencing a Laboratory Abnormality (Grade 3-4)|"A laboratory abnormality is defined as an adverse event of grade 3 or 4 identified by a laboratory test of participant blood samples.~Adverse events were graded according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE)."|Up to 42 weeks|Intention to treat|||Participants|||Count of Participants
2577304|NCT02441309|Secondary|Number of Patients Experiencing a Grade 3 or More Severe Adverse Event (Graded According to CTCAE Criteria v4.0)|"Toxicity measured and graded according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE)~Grade refers to the severity of the adverse event. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline:~Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.~Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.~Grade 3 Severe; medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling or limiting self care activities of daily living.~Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE."|Up to 42 weeks|Intention to treat|||Participants|||Count of Participants
2577305|NCT02441309|Secondary|Objective Radiological Response Based on RECIST v1.1|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) assessed by CT or MRI:~Complete Response (CR): Disappearance of all target and non-target lesions Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions, AND no evidence of progression in non-target lesions, AND no new lesions Stable Disease (SD): sum of longest diameter of target lesions between PR and PD values, AND no evidence of progression in non-target lesions, AND no new lesions Progressive Disease (PD): >20% increase in the sum of the longest diameter of target lesions, OR evidence of progression in non-target lesions, OR evidence of new lesions"|Change from Baseline to after 12, 18, 24 & 36 weeks and end of treatment visit|The end of treatment visit was completed by patients who were deemed to progress or withdrew from trial treatment at a time that a scheduled scan was not due to be taken. This end of treatment visit was used to confirm radiological progression.|||Participants|||Count of Participants
2577306|NCT02441309|Primary|Radiological Response Defined as Complete or Partial Response and Assessed Using RECIST Criteria|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) assessed by CT or MRI:~Complete Response (CR): Disappearance of all target and non-target lesions Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions, AND no evidence of progression in non-target lesions, AND no new lesions Stable Disease (SD): sum of longest diameter of target lesions between PR and PD values, AND no evidence of progression in non-target lesions, AND no new lesions Progressive Disease (PD): >20% increase in the sum of the longest diameter of target lesions, OR evidence of progression in non-target lesions, OR evidence of new lesions"|Change from Baseline to after 6 weeks of treatment|All patients are included since this is an intention to treat analysis.|||Participants|||Count of Participants
2577307|NCT02441309|Primary|Biological Response Data Based on Pharmacodynamic Endpoints on Tumour Biopsy Material|Biological response data based on pharmacodynamic endpoints on tumour biopsy material including macrophage infiltration and innate immune activation.|Change from Baseline to after 6 weeks of treatment|Insufficient number of participants for events for both primary and secondary objectives. The study stopped prematurely because of poor recruitment, meaning that no complete statistical analysis was possible as there were insufficient events and data were not collected.||||||
2577308|NCT02441218|Secondary|Secondary Composite Endpoint|CV death, hospitalisation for worsening HF or hospitalisation for non-fatal myocardial infarction|From the date of randomisation to the date of the first event, up to 42 months||||participants|||Number
2577309|NCT02441218|Secondary|Unplanned Hospitalisation for CV Reason||From the date of randomisation to the first documented hospitalisation, up to 42 months.||||participants|||Number
2577310|NCT02441218|Secondary|Unplanned Hospitalisation for Any Cause||From the date of randomisation to the first documented hospitalisation, up to 42 months||||participants|||Number
2577318|NCT02441179|Secondary|Learning and Memory With the Complutense Verbal Learning Test (TAVEC)|"The TAVEC is the Spanish version of the California Verbal Learning Test and is used for the assessment of episodic verbal memory.~Z score ranges from -2 (worse outcome), -1, 0, 1 and 2 (best outcome). The normal population range is between -1 and 1.~Z score was calculated with the following formula: Z score = (direct score-average for a particular age range)/standard deviation"|Episodic verbal memory at week 4.|"Analysis per protocol"|||Z scores||Inter-Quartile Range|Median
2577319|NCT02441179|Secondary|Learning and Memory With the Rey-Osterrieth Complex Figure (ROCF) Test|"The ROCF is a neuropsychological instrument used for assessment of episodic visual memory.~Z score ranges from -2 (worse outcome), -1, 0, 1 and 2 (best outcome). The normal population range is between -1 and 1.~Z score was calculated with the following formula: Z score = (direct score-average for a particular age range)/standard deviation"|Episodic visual memory at week 4.|"Analysis per protocol"|||Z scores||Inter-Quartile Range|Median
2577320|NCT02441179|Secondary|"Percentage of Subjects With Worsening Pain Perception on the The Visual Analog Test"|The visual analog test assess general pain intensity. It is a 10-score scale ranging from no pain (score 0) to unbearable pain (score 10).|Pain perception at week 4|"Analysis per protocol"|||percentage of subjects|||Number
2577321|NCT02441179|Secondary|Percentage of Subjects With Worsening Muscle Tone on the Ashworth Scale|The Ashworth Scale assess muscle tone. It is a 5-points scale ranging from 0 (no increase in muscle tone) to 4 (limb rigid in flexion or extension).|Muscle tone at week 4.|"Analysis per protocol"|||percentage of subjects|||Number
2577322|NCT02441179|Secondary|Gait Speed With the Timed up and go Test|The timed up and go test measures the time (in seconds) it takes the patient to stand-up from a seated position in a chair, walk 3 meters at a comfortable and safe pace, turn, walk back to the chair and sit down.|Change from baseline in gait speed five days after daily IH.|"The analysis was per protocol"|||seconds||Standard Error|Mean
2577323|NCT02441179|Secondary|Gait Endurance With the 6-Minute Walk Test|The 6-Minute Walk Test measures the distance (in meters) a patient is able to walk over 6 minutes.|Change from baseline in gait indurance five days after daily IH.|"The analysis was per protocol"|||meters||Standard Error|Mean
2577324|NCT02441179|Primary|Gait Speed With 10-Meter Walk Test|The 10-meter walk test measures the time (in seconds) that it takes a patient to walk 10m.|Change from baseline in gait speed five days after daily IH.|"Analysis was per protocol"|||seconds||Standard Error|Mean
2577325|NCT02441114|Secondary|Maximum Observed Concentration (Cmax)|Maximum observed concentration of fluticasone|Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose|10 subjects for period 1 and 2; 6 subjects for period 3|||pg/mL||Standard Deviation|Mean
2577326|NCT02441114|Secondary|Time to Maximum Concentration (Tmax)|Time to maximum concentration of fluticasone|Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose|10 subjects for period 1 and 2; 6 subjects for period 3|||h||Full Range|Median
2577327|NCT02441114|Primary|Area Under the Concentration Versus Time Curve (AUClast)|Area under the concentration of fluticasone versus time curve from the time of dosing to the last measurable concentration|Period 1 (day 1), 2 (day 15), and 3 (day 29) at 0 to 24 h post-dose|10 subjects for period 1 and 2; 6 subjects for period 3|||h*pg/mL||Standard Deviation|Mean
2577328|NCT02441036|Primary|Changes in Protein Expression in Tissues Treated With Ultherapy Compared to Control (Untreated) Tissue by Immunohistochemistry|Protein expression of apoptotic genes and heat shock proteins of interest identified in the three previous outcomes will be analyzed. Embedded or frozen section tissues will be stained for specific proteins previously identified. The number of subjects with differentially expressed proteins in treated samples compared to control samples will be determined for every study group.|1-3 hours to up to 45 days following Ultherapy treatment|Unanticipated sample collection/preservation issues reduced the number of samples available to 9 samples out of the 15 minimum required. These did not represent all intended time points. Study analyses were not performed as achieving meaningful outcomes was not possible with the small sample of specimens, i.e., data were not collected.||||||
2577329|NCT02441036|Primary|Changes in Gene Expression of Heat Shock Proteins Genes Induced in Tissues Treated With Ultherapy Relative to Control (Untreated) Tissues by PCR Array|Real-time PCR array will be performed to assess differences in gene expression of a cluster of 84 Heat Shock Protein genes that regulate protein folding (e.g. HSP90 (81 to 99 kD), HSP70 (65 to 80 kD), HSP60 (55 to 64 kD), HSP40 (35 to 54 kD), small HSPs (=34 kD) and other chaperone cofactors) between control versus treated tissues. The number of differentially expressed genes in treated samples compared to control samples will be determined for every study group.|1-3 hours to up to 45 days following Ultherapy treatment|Unanticipated sample collection/preservation issues reduced the number of samples available to 9 samples out of the 15 minimum required. These did not represent all intended time points. Study analyses were not performed as achieving meaningful outcomes was not possible with the small sample of specimens, i.e., data were not collected.||||||
2577330|NCT02441036|Primary|Changes in Gene Expression of Apoptotic Genes Induced in Tissues Treated With Ultherapy Relative to Control (Untreated) Tissues by PCR Array|Real-time PCR array will be performed to assess differences in gene expression of a cluster of 84 genes related to apoptosis (e.g. Annexin V, Caspacin, TNF ligands and their receptors, members of the bcl-2, caspase, IAP, TRAF, CARD, death domain, death effector domain, and CIDE families, as well as genes involved in the p53 and DNA damage pathways) between control versus treated tissues. The number of differentially expressed genes in treated samples compared to control samples will be determined for every study group.|1-3 hours to up to 45 days following Ultherapy treatment|Unanticipated sample collection/preservation issues reduced the number of samples available to 9 samples out of the 15 minimum required. These did not represent all intended time points. Study analyses were not performed as achieving meaningful outcomes was not possible with the small sample of specimens, i.e., data were not collected.||||||
2577350|NCT02440789|Secondary|Change in HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses|Change in frequency of HIV-1 Gag-specific CD40L+ CD4+ T-cells (week 32 measurement minus baseline measurement).|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||%GAG-specific CD40L+ CD4+ T-Cells||Standard Deviation|Mean
2577351|NCT02440789|Secondary|Measurement of HIV-1 Gag-specific CD40L+ CD4+ T-cell Responses|Frequency of HIV-1 Gag-specific CD40L+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||%GAG-specific CD40L+ CD4+ T-Cells||Standard Deviation|Mean
2577331|NCT02441036|Primary|Changes in Gene Expression in Facial Skin Tissue Treated With Ultherapy Compared to Control (Untreated) Tissue Through Microarray Profiling|"RNA will be extracted from treated and untreated (control) tissue samples obtained from 15 study subjects. For each subject tissue of the contra-lateral side of the face served as a control and will not receive Ultherapy treatment.~OneArray Human Gene Expression microarray will be used for microarray profiling. Clustering Analysis will be performed to identify differences between treated vs. control samples and the up and down-regulated genes will be represented in a heatmap. The number of differentially expressed genes in treated samples compared to control samples will be determined for every study group."|1-3 hours to up to 45 days following Ultherapy treatment|Unanticipated sample collection/preservation issues reduced the number of samples available to 9 samples out of the 15 minimum required. These did not represent all intended time points. Study analyses were not performed as achieving meaningful outcomes was not possible with the small sample of specimens, i.e., data were not collected.||||||
2577332|NCT02440789|Secondary|Change in of %PD1+ CD8+ T-cells|Change in of %PD1+ CD8+ T-cells (week 32 measurement minus baseline measurement)|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||%PD1+ CD8+ T-Cells||Standard Deviation|Mean
2577333|NCT02440789|Secondary|Measurement of %PD1+ CD8+ T-cells|Measurement of %PD1+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||%PD1+ CD8+ T-Cells||Standard Deviation|Mean
2577334|NCT02440789|Secondary|Change in of %PD1+ CD4+ T-cells|Change in of %PD1+ CD4+ T-cells (week 32 measurement minus baseline measurement)|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||%PD1+ CD4+ T-Cells||Standard Deviation|Mean
2577335|NCT02440789|Secondary|Measurement of %PD1+ CD4+ T-cells|Measurement of %PD1+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||%PD1+ CD4+ T-Cells||Standard Deviation|Mean
2577336|NCT02440789|Secondary|Change in of %Ki67+ CD8+ T-cells|Change in of %Ki67+ CD8+ T-cells (week 32 measurement minus baseline measurement)|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||%Ki67+ CD8+ T-Cells||Standard Deviation|Mean
2577337|NCT02440789|Secondary|Measurement of %Ki67+ CD8+ T-cells|Measurement of %Ki67+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||%Ki67+ CD8+ T-Cells||Standard Deviation|Mean
2577338|NCT02440789|Secondary|Change in of %Ki67+ CD4+ T-cells|Change in of %Ki67+ CD4+ T-cells (week 32 measurement minus baseline measurement).|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||%Ki67+ CD4+ T-Cells||Standard Deviation|Mean
2577339|NCT02440789|Secondary|Measurement of %Ki67+ CD4+ T-cells|Measurement of %Ki67+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||%Ki67+ CD4+ T-Cells||Standard Deviation|Mean
2577340|NCT02440789|Secondary|Change in of %CD69+ CD8+ T-cells|Change in of %CD69+ CD8+ T-cells (week 32 measurement minus baseline measurement)|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||%CD69+ CD8+ T-Cells||Standard Deviation|Mean
2577341|NCT02440789|Secondary|Measurement of %CD69+ CD8+ T-cells|Measurement of %CD69+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||%CD69+ CD8+ T-Cells||Standard Deviation|Mean
2577342|NCT02440789|Secondary|Change in of %CD69+ CD4+ T-cells|Change in of %CD69+ CD4+ T-cells (week 32 measurement minus baseline measurement).|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||%CD69+ CD4+ T-Cells||Standard Deviation|Mean
2577343|NCT02440789|Secondary|Measurement of %CD69+ CD4+ T-cells|Measurement of %CD69+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||%CD69+ CD4+ T-Cells||Standard Deviation|Mean
2577344|NCT02440789|Secondary|Change in HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses|Change in frequency of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cells (week 32 measurement minus baseline measurement).|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||%GAG-specific TNF-alpha+ CD4+ T-Cells||Standard Deviation|Mean
2577345|NCT02440789|Secondary|Measurement of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cell Responses|Frequency of HIV-1 Gag-specific TNF-alpha+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||%GAG-specific TNF-alpha+ CD4+ T-Cells||Standard Deviation|Mean
2577346|NCT02440789|Secondary|Change in HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses|Change in frequency of HIV-1 Gag-specific MIP1B+ CD4+ T-cells (week 32 measurement minus baseline measurement).|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||%GAG-specific MIP1B+ CD4+ T-Cells||Standard Deviation|Mean
2577347|NCT02440789|Secondary|Measurement of HIV-1 Gag-specific MIP1B+ CD4+ T-cell Responses|Frequency of HIV-1 Gag-specific MIP1B+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||%GAG-specific MIP1B+ CD4+ T-Cells||Standard Deviation|Mean
2577348|NCT02440789|Secondary|Change in HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses|Change in frequency of HIV-1 Gag-specific IL-2+ CD4+ T-cells (week 32 measurement minus baseline measurement)|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||%GAG-specific IL-2+ CD4+ T-Cells||Standard Deviation|Mean
2577349|NCT02440789|Secondary|Measurement of HIV-1 Gag-specific IL-2+ CD4+ T-cell Responses|Frequency of HIV-1 Gag-specific IL-2+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||%GAG-specific IL-2+ CD4+ T-Cells||Standard Deviation|Mean
2577352|NCT02440789|Secondary|Change in HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses|Change in frequency of HIV-1 Gag-specific CD107a+ CD4+ T-cells (week 32 measurement minus baseline measurement)|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||%GAG-specific CD107a+ CD4+ T-Cells||Standard Deviation|Mean
2577353|NCT02440789|Secondary|Measurement of HIV-1 Gag-specific CD107a+ CD4+ T-cell Responses|Frequency of HIV-1 Gag-specific CD107a+ CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||%GAG-specific CD107a+ CD4+ T-Cells||Standard Deviation|Mean
2577354|NCT02440789|Secondary|Change in HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses|Change in HIV-1 Gag-specific CD4+ T-cells by intracellular staining for IFN-gamma (week 32 measurement minus baseline measurement)|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||%GAG-specific IFN-g+ CD4+ T-Cells||Standard Deviation|Mean
2577355|NCT02440789|Secondary|Measurement of HIV-1 Gag-specific CD4+ T-cell by Intracellular Staining for IFN-gamma Responses|Frequency of HIV-1 Gag-specific CD4+ T-cells by intracellular staining for IFN-gamma. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||%GAG-specific IFN-g+ CD4+ T-Cells||Standard Deviation|Mean
2577356|NCT02440789|Secondary|Change in HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses|Change in frequency of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cells (week 32 measurement minus baseline measurement)|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||%GAG-specific TNF-a+ CD8+ T-Cells||Standard Deviation|Mean
2577357|NCT02440789|Secondary|Measurement of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cell Responses|Frequency of HIV-1 Gag-specific TNF-alpha+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||%GAG-specific TNF-a+ CD8+ T-Cells||Standard Deviation|Mean
2577358|NCT02440789|Secondary|Change in HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses|Change in frequency of HIV-1 Gag-specific MIP1B+ CD8+ T-cells (week 32 measurement minus baseline measurement)|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||%GAG-specific MIP1B+ CD8+ T-Cells||Standard Deviation|Mean
2577359|NCT02440789|Secondary|Measurement of HIV-1 Gag-specific MIP1B+ CD8+ T-cell Responses|Frequency of HIV-1 Gag-specific MIP1B+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||%GAG-specific MIP1B+ CD8+ T-Cells||Standard Deviation|Mean
2577360|NCT02440789|Secondary|Change in HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses|Change in frequency of HIV-1 Gag-specific IL-2+ CD8+ T-cells (week 32 measurement minus baseline measurement)|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||%Gag-specific IL-2+ CD8+ T-cells||Standard Deviation|Mean
2577361|NCT02440789|Secondary|Measurement of HIV-1 Gag-specific IL-2+ CD8+ T-cell Responses|Frequency of HIV-1 Gag-specific IL-2+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||%Gag-specific IL-2+ CD8+ T-cells||Standard Deviation|Mean
2577362|NCT02440789|Secondary|Change in HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses|Change in frequency of HIV-1 Gag-specific CD40L+ CD8+ T-cells (week 32 measurement minus baseline measurement)|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||%Gag-specific CD40L+ CD8+ T-cells||Standard Deviation|Mean
2577363|NCT02440789|Secondary|Measurement of HIV-1 Gag-specific CD40L+ CD8+ T-cell Responses|Frequency of HIV-1 Gag-specific CD40L+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||%Gag-specific CD40L+ CD8+ T-cells||Standard Deviation|Mean
2577364|NCT02440789|Secondary|Change in HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses|Change in frequency of HIV-1 Gag-specific CD107a+ CD8+ T-cells (week 32 measurement minus baseline measurement)|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||%Gag-specific CD107a+ CD8+ T-cells||Standard Deviation|Mean
2577365|NCT02440789|Secondary|Measurement of HIV-1 Gag-specific CD107a+ CD8+ T-cell Responses|Frequency of HIV-1 Gag-specific CD107a+ CD8+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||%Gag-specific CD107a+ CD8+ T-cells||Standard Deviation|Mean
2577366|NCT02440789|Secondary|Change in Cell-associated HIV-1 DNA Levels in Total CD4+ Cells|Change in HIV-1 DNA levels in CD4+ T-cells (week 32 measurement minus baseline measurement)|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||log10(copies/10^6 CD4+ T-cells)||Standard Deviation|Mean
2577367|NCT02440789|Secondary|Cell-associated HIV-1 DNA Levels in Total CD4+ Cells|HIV-1 DNA levels in CD4+ T-cells. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||log10(copies/10^6 CD4+ T-cells)||Standard Deviation|Mean
2577368|NCT02440789|Secondary|Measurement of HIV-1 RNA Levels|HIV-1 RNA levels by conventional assay|weeks 0, 12, (pre-Sirolimus) 16, 24, 32 (4, 12, 20 weeks on Sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||Participants|||Count of Participants
2577369|NCT02440789|Secondary|Change in CD4+ T-cell Counts|Change in CD4+ T-cell counts (week 32 measurement minus baseline measurement)|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||cells/mm^3||Standard Deviation|Mean
2577370|NCT02440789|Secondary|Measurement of CD4+ T-cell Counts|CD4+ T-cell counts. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12, 16, 24, 32 (4, 12, 20 weeks on sirolimus) and 44|Participants completing 20 weeks of Sirolimus|||cells/mm^3||Standard Deviation|Mean
2577790|NCT02435511|Other Pre-specified|Access to Resources - Rent/Mortgage as Measured by Questionnaire Developed for This Study|Measure perceived and self-reported access to help paying rent or mortgage|Baseline, 1 week, 1 month and 3 months|||||||
2577371|NCT02440789|Primary|Efficacy - Virologic: Change in Plasma HIV-1 RNA by SCA|"Change in plasma HIV-1 RNA by SCA (week 32 measurement minus baseline measurement).~Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12)."|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||log10(copies/mL)||Standard Deviation|Mean
2577372|NCT02440789|Primary|Efficacy - Virologic: Plasma HIV-1 RNA by SCA|Plasma HIV-1 RNA by SCA|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||Participants|||Count of Participants
2577373|NCT02440789|Primary|Efficacy - Virologic: Change in CD4+ T-cell-associated HIV-1 RNA|Change in CD4+ T-cell-associated HIV-1 RNA (week 32 measurement minus baseline measurement)|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||log10(copies/10^6 CD4+ T-cells)||Standard Deviation|Mean
2577374|NCT02440789|Primary|Efficacy - Virologic: CD4+ T-cell-associated HIV-1 RNA|CD4+ T-cell-associated HIV-1 RNA. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||log10(copies/10^6 CD4+ T-cells)||Standard Deviation|Mean
2577375|NCT02440789|Primary|Efficacy - Immunologic: Change in HIV-1 Gag-specific CD8+ T-cells by Intracellular Staining for IFN-gamma|Change in HIV-1 Gag-specific CD8+ T-cells by intracellular staining for IFN-gamma (week 32 measurement minus baseline measurement)|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||%GAG-specific IFN-gamma+ CD8+ T-cells||Standard Deviation|Mean
2577376|NCT02440789|Primary|Efficacy - Immunologic: Frequency of HIV-1 Gag-specific CD8+ T-cells by Intracellular Staining for IFN-gamma|Frequency of HIV-1 Gag-specific CD8+ T-cells by intracellular staining for IFN-gamma. Baseline is the mean of the two pre-Sirolimus measurements (study entry and study week 12).|At study weeks 0, 12 and 32 (week 20 on Sirolimus)|Participants completing 20 weeks of Sirolimus|||%GAG-specific IFN-gamma+ CD8+ T-cells||Standard Deviation|Mean
2577377|NCT02440789|Primary|Number of Participants Who Met the Study-defined Composite Safety Endpoint|The study-defined primary safety endpoint was a composite endpoint. A participant was considered to have met the endpoint if the participant 1) experienced a new Grade ≥3 Adverse Event (AE), including signs/symptoms, lab toxicity or clinical event, that was definitely, probably or possibly related to study treatment, as judged by the core team, or 2) had a change in CD4+ cell count ( confirmed >50% decline or to <300 cells/mm3) while on sirolimus. The screening visit occurred within 60 days of study entry.|Screening to study week 32 (week 20 of Sirolimus)|Participants Initiating Sirolimus.|||Participants|||Count of Participants
2577378|NCT02440659|Primary|Patient's Quality of Life|% of patients very much or extremely affected by dialysis|Baseline||||% of patients|||Number
2577379|NCT02440633|Primary|AUC of OPS-2071 in Plasma|A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured OPS-2071 concentration in plasma and evaluated AUC 0-168h of OPS-2071 in plasma.|predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.||||μg·h/L||Standard Deviation|Mean
2577380|NCT02440633|Primary|Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood|A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured total radioactivity in plasma and whole blood each. We evaluated AUC 0-168h of total radioactivity in plasma and whole blood each. The AUCs in plasma and whole blood are of total radioactivity including the parent and metabolites.|predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.||||μg eq.·h/L||Standard Deviation|Mean
2577381|NCT02440633|Primary|The Amounts of Radioactivity Excreted in Urine and Faeces|A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We evaluated the cumulative excretion of total radioactivity (%) in feces and urine, up to 168 hours postdose.|up to144-168h postdose.||||percentage of administered dose||Standard Deviation|Mean
2577382|NCT02440594|Secondary|Number of Participants With Moderately Severe to Severe Depression (Per Patient Health Questionnaire-9 (PHQ-9))|Number of participants with moderately severe to severe depression at Baseline, 3 and 6 months; Depression diagnosis (i.e., moderately severe - severe depression vs. no - minimal depression or minor - moderate depression) based on a 9-item measure of depressive symptom severity in past 2 weeks.|Baseline and 3 and 6 month follow-up|Numbers represent number of participants in each low symptom arm who met criteria for moderately severe - severe depression at 3 and 6 months. Due to their different symptom profiles, these outcome data were only collected/extracted at baseline for the high symptom groups.|||participants|||Number
2577383|NCT02440594|Secondary|Generalized Anxiety Disorder - 7 (GAD-7)|A 7-item measure of anxiety symptom severity over the past 2 weeks. Possible range = 0 - 21; higher scores indicated greater anxiety symptom severity|Baseline and 3 and 6 month follow-up|SUSTAIN participants prescribed an antidepressant or anxiolytic and endorsed high baseline MH symptoms during the initial clinical interview. Due to their different symptom profiles and index medications, these outcome data were only collected/extracted at baseline for the low symptom and AP groups, respectively.|||units on a scale||Standard Deviation|Mean
2577384|NCT02440594|Secondary|Patient Health Questionnaire-9 (PHQ-9)|A 9-item measure of depressive symptom severity in past 2 weeks. Possible range = 0-27; higher scores indicate higher depressive symptom severity.|Baseline and 3 and 6 month follow-up|Analyses run for SUSTAIN program participants who were prescribed, 1) an AD or AX and endorsed high baseline MH symptoms during the initial clinical interview and, 2) an AP and endorsed high baseline MH symptoms. Due to their low baseline symptom severity, these outcome data were only collected/extracted at baseline for the low symptom groups.|||score on a scale||Standard Deviation|Mean
2577385|NCT02440594|Primary|Zarit Burden Interview (ZBI)|Brief, 4-item version of the Zarit Burden Interview; Possible range = 0-16; higher scores denote greater perceived caregiving burden. This measure was only collected of caregivers who participated in SUSTAIN program services.|Baseline and 3 and 6 month follow-up|Caregivers who completed a baseline clinical interview and agreed to SUSTAIN caregiver services.|||score on a scale||Standard Deviation|Mean
2577404|NCT02439320|Other Pre-specified|Percentage of Participants With Resource Utilization|Use of health care for treatment 6 months prior to enrolling in the study and information reported during time on study|6 months prior to enrolling in study to end of study (Up to 11 Weeks) within 7 days of treating a single migraine attack|All randomized participants who used at least 1 dose of study drug, regardless of whether or not they underwent any study assessments.|||percentage of participants|||Number
2577386|NCT02440594|Primary|Medical Outcomes Survey Short Form (SF12) Mental Component Subscale (MCS) Score|A measure of overall mental health functioning as measured by the Medical Outcomes Survey Short Form (SF12) MCS subscale. Possible range = 0-100; higher scores mean better overall health functioning.|Baseline and 3 and 6 month follow-up|SUSTAIN participants who were prescribed an AD or AX (per pharmacy records) and endorsed high baseline MH symptoms during the initial clinical interview. This was not a primary outcome measure for those patients assigned to the other 4 groups; data were extracted from clinical records only for patients assigned to the two designated arms.|||score on a scale||Standard Deviation|Mean
2577387|NCT02440451|Other Pre-specified|Debriefing Interview Questionnaire|Covers: strategies; general experience of the process; adverse effects;|8 weeks (Endpoint 1)|||||||
2577388|NCT02440451|Other Pre-specified|BDI - Beck Depression Inventory|21-item measure of clinical depression|8 weeks (Endpoint 1) plus 6 months follow-up|||||||
2577389|NCT02440451|Other Pre-specified|HADS - Hospital Anxiety & Depression Scale|24-item scale (7 depression & 7 anxiety items)|8 weeks (Endpoint 1) plus 6 months follow-up|||||||
2577390|NCT02440451|Other Pre-specified|POMS - Profile of Mood States||8 weeks (Endpoint 1) plus 6 months follow-up|||||||
2577391|NCT02440451|Secondary|VABS - Vineland Adaptive Behaviour Scale|"The Vineland Adaptive Behaviour Scale (VABS) is a semi-structured interview designed to assess global adaptive functioning, composed by 3 main domains: Communication COM, Daily Living Skills DLS and Socialization SOC (all reported here in terms of standard scores as described in the VABS manual, i.e. mean 100 and standard deviation 15).~The Adaptive Behaviour Composite ABC (total score, also reported here) is the sum of the raw scores from the three main domains. These are transformed in standard scores (m.=100;std.=15).~The higher the score, better is the adaptive behavior."|8 weeks (Endpoint 1) plus 6 months follow-up||||units on a scale||Standard Deviation|Mean
2577392|NCT02440451|Secondary|ATEC - Autism Treatment Evaluation Checklist|"Autism Treatment Evaluation Checklist (ATEC) evaluates the effectiveness of autism treatments - a 1-page form designed to be completed by parents or caretakers. It consists of 4 subtests: I. Speech/Language Communication (14 items, min.0-max.28); II. Sociability (20 items, min.0-max.40); III. Sensory/Cognitive Awareness (18 items, min.0-max.36); and IV. Health/Phys./Behavior (25 items, min.0-max.75). Total score (sum) ranges from min.0-max.179.~The results reported here correspond to the total ATEC score to be used for comparison at a later date. The lower the score, the fewer the problems."|8 weeks (Endpoint 1) plus 6 months follow up||||units on a scale||Standard Deviation|Mean
2577393|NCT02440451|Primary|FEEST - Facial Expression of Emotion: Stimuli and Tests|The Emotion Hexagon test represents the primary outcome measure. The assessment based on this test will be performed before (baseline), after the intervention - endpoint 1 (at 8 weeks) and at the 6 months follow-up. The Emotion Hexagon test uses stimuli of graded difficulty, created using computer image manipulation techniques (morphing is used to modify photographs from the Ekman and Friesen (1976) series, creating examples that lie close to or more distant from the prototype expression). The 120 test trials with unambiguous stimuli (4 pictures for each of the 6 emotions across the 5 test blocks) can be used to derive an overall (total) score out of a possible maximum of 120 expressions correctly recognized.|8 weeks (Endpoint 1) plus 6 months follow-up||||units on a scale||Standard Deviation|Mean
2577394|NCT02440334|Primary|The Sensitivity of Detecting RCC Recurrence (Using Contrast-enhanced MRI as a Reference Standard) on a Single Contrast-enhanced Ultrasound Exam.|Patients scheduled for follow up contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) of a previously cryoablatated renal cell carcinoma (RCC) through Thomas Jefferson University's Urology clinic will undergo a single ultrasound exam using contrast enhanced ultrasound. Ultrasound imaging will be performed using a state of the art ultrasound scanner with two and three dimensional curvilinear transducers.|8 months post cryoblation||||percent of patients|||Number
2577395|NCT02440308|Secondary|68Ga-DOTA-Bombesin Feasibility|Feasibility of 68Ga-DOTA-Bombesin as a radiopharmaceutical for PET/MRI was assessed as the percentage of enrolled subjects who complete the examination, and for which the PET/MRI data were evaluable.|Up to 1 week|Includes all participants enrolled.|||percentage of participants|||Number
2577396|NCT02440308|Primary|Normal Biodistribution of 68Ga-DOTA-Bombesin|Radiopharmaceutical uptake in normal organs will be evaluated visually and measured semi-quantitatively using standardized uptake values (SUV) derived from the PET/CT scan software in patients with prostate cancer. Uptake values in different tissues will be measured as SUVmean (mean value for SUV). SUVmean values reflect relative uptake of the radiolabel into the tissue.|1 hour|All participants were averaged to provide SUVmean uptake in normal organs.|||SUV-mean||Standard Deviation|Mean
2577397|NCT02440204|Secondary|EC95 for Successful Intubation|Sevoflurane concentration used to perform intubation (For ED95 finding)|During the induction of anesthesia||||vol%||95% Confidence Interval|Mean
2577398|NCT02440204|Primary|EC50 for Successful Intubation in Each Groups|Sevoflurane concentration used to perform intubation (For ED50 finding)|During the induction of anesthesia||||vol%||95% Confidence Interval|Mean
2577399|NCT02439879|Primary|Total Symptoms Score|Total symptoms score is a summation of presence, severity, and duration of the four main positive neuropathic sensory symptoms: lancinating/stabbing pain, burning pain, paresthesia, and asleep numbness|20 weeks||||units on a scale||Standard Error|Mean
2577400|NCT02439814|Primary|Subjective Rating of Marijuana Craving on 1-7 Likert Scale|Change in craving from post medication administration to post active cue. Scale of 1-7 with 7 meaning the craving is most severe.|12:40 to 14:45 (post med administration, post Marijuana cue||||units on a scale||Standard Deviation|Mean
2577401|NCT02439710|Primary|Cost Per Completed Survey|Human and financial resources used by local organization to run the survey - measured as median and full range|1 year||||Dollars (USD) per participants||Full Range|Median
2577402|NCT02439710|Primary|Number of Participant Completing the Questionnaire Within 15 Minutes|Number of participants completing the questionnaire within 15 minutes|Up to 15 minutes||||participants|||Number
2577403|NCT02439710|Primary|Response Rate|number of filled questionnaires compared to the total number that were sent out|1 year|patients with hemophilia (hemophilia A or B with any degree of disease severity) or controls|||Questionnaires|Questionnaires||Count of Units
2577501|NCT02437903|Other Pre-specified|Subject Self-Perception of Age|Subjects perception of age when the subject looks at his/her right and left temples|Baseline, month 1, month 3, month 6, month 9, and Month 12|All subjects with data for this outcome measure|||Participants|||Count of Participants
2577405|NCT02439320|Secondary|Participants With Serious Adverse Events (SAE)|Safety and Tolerability was assessed by the number of participants with at least 1 treatment emergent event (TEAE). A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section|Baseline up to 11 weeks|All randomized participants who had received at least one dose of study drug. Results are displayed by the first dose taken.|||Participants|||Count of Participants
2577406|NCT02439320|Secondary|Percentage of Participants Photophobia Free|The percentage of participants without photophobia.|2 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable photophobia free data.|||percentage of participants|||Number
2577407|NCT02439320|Secondary|Percentage of Participants Phonophobia Free|The percentage of participants without phonophobia.|2 hours post dose|All randomized participants who used at least 1 dose of study drug and had any post-dose headache severity or symptom assessments.|||percentage of participants|||Number
2577408|NCT02439320|Secondary|Percentage of Participants Nausea Free|The percentage of participants without nausea.|2 hours post dose|All randomized participants who used at least 1 dose of study drug and had any post-dose headache severity or symptom assessments.|||percentage of participants|||Number
2577409|NCT02439320|Secondary|Percentage of Participants Who Used Rescue Medication|Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).|Anytime 24-48 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data.|||percentage of participants|||Number
2577410|NCT02439320|Secondary|Percentage of Participants Who Used Rescue Medication|Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).|Anytime between 2-24 hours post dose|Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.|||percentage of participants|||Number
2577411|NCT02439320|Secondary|Percentage of Participants Who Used Rescue Medication|Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).|2 hours post dose|Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.|||percentage of participants|||Number
2577412|NCT02439320|Secondary|Percentage of Participants With Headache Recurrence|Participants who received study drug and which became pain free at 2 hours post-dose and worsened again up to 48 hours post-dose.|From 2 hours post dose up to 48 hours|Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.|||percentage of participants|||Number
2577413|NCT02439320|Secondary|Percentage of Participants Who Have Headache Relief After First Dose|The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.|2 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable headache relief data.|||percentage of participants|||Number
2577414|NCT02439320|Primary|Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free|The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.|2 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable MBS data.|||percentage of participants|||Number
2577415|NCT02439320|Primary|Percentage of Participants Who Are Headache Pain Free|The percentage of participants defined as mild, moderate, or severe headache pain becoming none.|2 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable headache pain free data.|||percentage of participants|||Number
2577416|NCT02439281|Secondary|Medication Consumption|Total intravenous morphine equivalents mg/kg|18 hours after surgery|Only patients with successful blocks were included. Two patients were deemed to have incomplete/ failed blocks and 2 patients did not have any blocks.|||mg/kg||Inter-Quartile Range|Median
2577417|NCT02439281|Secondary|Average Pain Severity at the Umbilicus Laparoscopic Site|Numeric Rating Pain Scores ( 0-10), will be obtained every 2 hours after PACU discharge up to 18 hours or until hospital discharge, whichever occurs first. The pain score of 0, means no pain, is a good outcome , and a pain score of 10 is excruciating pain, a very bad outcome. The average of these scores will be evaluated.The pain scores will not longer be documented after the numbness went away.|Logistic regression of the 4 th pain score assessment|Only patients with available average pain scores at the 4 th pain assessment were compared.|||units on a scale||Inter-Quartile Range|Median
2577418|NCT02439281|Secondary|Duration of Analgesia at Umbilicus Instrument Site-How Many Minutes Passed From the Time When the Blocks Where Performed Until Patient Reported Pain at Umbilicus|The investigators hypothesize that rectus sheath injections with ropivacaine/ clonidine would result in longer duration of analgesia and decreased pain scores compared to ropivacaine alone.|indicated by the first request for pain medication at umbilicus site|only patients with documented duration of numbness and documented first pain scores at umbilicus were included in analysis of this secondary outcome|||minutes||Inter-Quartile Range|Median
2577419|NCT02439281|Secondary|Change in Anxiety Scores|The investigators hypothesize that patient postoperative anxiety scores are lower in the Ropivacaine/Clonidine group and postoperative anxiety scores decrease more in Ropivacaine /Clonidine Group, than in Ropivacaine Group.|6 hours after block placement|Only patients that a completed anxiety scale were analyzed . State-Trait Anxiety Inventory for Children consists of 20 statements; how they feel at that particular moment ( “I feel…”), by checking one of the three alternatives that describe the child best “very calm,” “calm,” or “not calm”). The total score ranges from 20-60 ( worse outcome).|||units on a scale||Inter-Quartile Range|Median
2577420|NCT02439281|Secondary|Complications Rate|The investigators expect no difference in incidence of complications (e.g. oversedation, hypotension, bradycardia episodes, etc.).|until study completion|The patients that received a nerve block were analysed.|||Participants|||Count of Participants
2577421|NCT02439281|Secondary|Satisfaction With Pain Control From Patient|The investigators hypothesize that rectus sheath injections with ropivacaine/ clonidine would result in better satisfaction with pain control.|Prior to hospital discharge (up to 24 hours after surgery)|only patients with satisfaction scores documented and other inclusion criteria met were analysed and compared; A numeric satisfaction scale 1-10 ( 1 not satisfied, 10 being very satisfied) was used|||units on a scale||Inter-Quartile Range|Median
2577422|NCT02439281|Primary|Duration of Sensory Block (Paresthesia)|The investigators hypothesize that rectus sheath injections with ropivacaine and clonidine result in longer duration of sensory block (paresthesia) compared to ropivacaine alone.|Indicated by return of normal sensation (expected average of 12 hours after block placement).|only patients that were able to report the time when the numbness went away were analysed and compared|||minutes||Inter-Quartile Range|Median
2577423|NCT02439164|Secondary|Brain Glioma Pathological Diagnose as a Measure of Tumor Type|the WHO grade and the type of glioma (WHO glioma grade I~II is regarded as low grade glioma, WHO glioma grade III~IV is regarded as high grade glioma)|2 weeks|"In non-neurosurgical group, patients were not diagnosed as glioma, so the belowed outcome measure data table could not indicate the number of glioma grade."|||Participants|||Count of Participants
2577424|NCT02439164|Secondary|Heart Rate as a Measure of Physiological Change|The HR was measured at three time points: baseline, sedation and sedation reversal.|1 hour||||bpm||Standard Deviation|Mean
2577425|NCT02439164|Secondary|Mean Arterial Blood Pressure (MAP) as a Measure of Physiological Change|The MAP was measured at three time points: baseline, sedation and sedation reversal.|1 hour||||mmHg||Standard Deviation|Mean
2577426|NCT02439164|Secondary|Number of Participants With OAA/S=4 After Sedation|OAA/S is Observer Assessment of Sedation with 5 levels (5 = alert, 4 = lethargic, 3 = aroused by voice, 2 = aroused by shaking, 1 = deep sleep), all participants have to achieve OAA/S=4 after sedation.|withing 1 hour||||Participants|||Count of Participants
2577427|NCT02439164|Primary|Task Completing Time Change Between Sedation and Baseline Measured by 9-hole Peg Test|this is a focal neurologic deficits induced by sedatives, the outcome is the performing time changes after sedation as : sedation-baseline.|after sedation||||seconds||Standard Deviation|Mean
2577428|NCT02439138|Secondary|Rate of Progressive Disease|Progressive disease measured by an 25% increase in serum IgM level with an absolute increase of at least 500mg/dL from the lowest attained IgM on therapy.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.||||percentage of participants with PD|||Number
2577429|NCT02439138|Secondary|Rate of Stable Disease|Stable disease measured by serum IgM levels <25% reduced from baseline.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.||||percentage of participants with SD|||Number
2577430|NCT02439138|Secondary|Rate of Minimal Response|Minimal response measured by decrease in serum IgM levels of between 25% and 50%.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.||||percentage of participants with MR|||Number
2577431|NCT02439138|Secondary|Rate of Partial Response (PR)|PR measured by decrease in serum IgM levels of between 25% and 50% from baseline.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.||||percentage of participants with PR|||Number
2577432|NCT02439138|Secondary|Rate of Very Good Partial Response (VGPR)|VGPR measured by decrease in serum IgM levels of at least 90% from baseline.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.||||percentage of participants with VGPR|||Number
2577433|NCT02439138|Secondary|Rate of Complete Response (CR)|CR measured by decrease in serum IgM levels to normal range, disappearnace of monoclonal protein by immunofixation, no evidence of bone marrow involvement, and resolution of any extramedullary disease by CT scan.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.||||percentage of participants with CR|||Number
2577434|NCT02439138|Secondary|Percentage of Participants With Adverse Events|Assess the safety and tolerability of idelalisib|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.||||percentage of participants with AEs|||Number
2577435|NCT02439138|Primary|Overall Response Rate (ORR)|ORR measured by decrease in serum IgM level by at least 25% from baseline.|Participants were followed for the duration of therapy, a median of one cycle, for up to 3 cycles.|4 of 5 participants returned for at least 1 follow-up to assess disease response.|||percentage of participants with response|||Number
2577436|NCT02438826|Secondary|Pharmacokinetics (PK): Serum Concentration of Galcanezumab|Pharmacokinetics (PK): Serum Concentration of Galcanezumab|Week 12|All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 12.|||nanogram per milliliter||Standard Deviation|Mean
2577437|NCT02438826|Secondary|Pharmacokinetics (PK): Serum Concentration of Galcanezumab|Pharmacokinetics (PK): Serum Concentration of Galcanezumab|Week 8|All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 8.|||nanogram per milliliter||Standard Deviation|Mean
2577438|NCT02438826|Secondary|Pharmacokinetics (PK): Serum Concentration of Galcanezumab|Pharmacokinetics (PK): Serum Concentration of Galcanezumab|Week 4|All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 4.|||nanogram per milliliter||Standard Deviation|Mean
2577439|NCT02438826|Secondary|Pharmacokinetics (PK): Serum Concentration of Galcanezumab|Pharmacokinetics (PK): Serum Concentration of Galcanezumab|Week 2|All randomized participants who received at least 1 dose of study drug and had evaluable galcanezumab PK samples at Week 2.|||nanogram per milliliter||Standard Deviation|Mean
2577440|NCT02438826|Secondary|Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab (LY2951742)|Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject has at least one post-baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post-baseline result of ADA present with titer >= 1: 20.|Baseline, Week 1 through Week 12|All randomized participants who received at least one dose of study drug and had non-missing baseline ADA result, and at least one non-missing post baseline ADA result.|||percentage of participants|||Number
2577456|NCT02438813|Primary|Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)|An adverse event is any undesirable medical occurrence or worsening of an existing condition that occurs after SMF reduction treatment, irrespective of whether the event is considered treatment related. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving treatment.|Up to 19 Months|Safety Population included all participants who received at least one treatment. Participants may have received more than one treatment.|||percentage of participants|||Number
2577441|NCT02438826|Secondary|Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)|"C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide."|Week 1 through Week 12|All randomized participants who received at least one dose of study drug and had at least one post baseline C-SSRS assessment.|||percentage of participants|||Number
2577442|NCT02438826|Secondary|Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)|"C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal ideation: a yes answer to any of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent."|Week 1 through Week 12|All randomized participants who received at least one dose of study drug and had at least one post baseline C-SSRS assessment.|||percentage of participants|||Number
2577443|NCT02438826|Secondary|Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)|PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects.|Week 12|All randomized participants who received at least one dose of study drug and had PGI-I measurement at week 12.|||percentage of participants|||Number
2577444|NCT02438826|Secondary|Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)|PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects.|Week 8|All randomized participants who received at least one dose of study drug and had PGI-I measurement at Week 8.|||percentage of participants|||Number
2577445|NCT02438826|Secondary|Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)|PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, verapamil use, baseline cluster headache attack category, month, and treatment by month as fixed effects.|Week 4|All randomized participants who received at least one dose of study drug and had PGI-I measurement at Week 4.|||percentage of participants|||Number
2577446|NCT02438826|Secondary|Percentage of Participants With a 30% Reduction in the Weekly Number of Cluster Headache Attacks|A 30% responder is any participant who has a ≥30% reduction from baseline in the weekly number of cluster headache attacks in a 14-day interval. Weeks 1/2, 3/4, 5/6, 7/8, 9/10, and 11/12. Mean percentage of participants is derived from the average of weeks 1/2 to weeks 11/12 from generalized linear mixed model repeated measures method with treatment, sex, verapamil use, week, treatment by week, and baseline as fixed effects. .|Baseline, Week 1 through Week 12|All randomized participants who received at least 1 dose of study drug, and had baseline and at least 1 post baseline value.|||percentage of participants||Standard Error|Mean
2577447|NCT02438826|Secondary|Percentage of Participants With a Sustained Response of 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks|Sustained Response is defined as a 50% or greater reduction in the weekly cluster attack frequency from baseline to Weeks 3/4 and maintained at Weeks 5/6, Weeks 7/8, Weeks 9/10, and Weeks 11/12. Percentage of participants with a sustained response was analyzed using Koch's nonparametric randomization-based analysis of covariance method. This method adjusted for pooled investigative site by including it as a stratification variable. It also adjusted for sex, verapamil use and baseline value.|Baseline, Week 3 through Week 12|All randomized participants who received at least 1 dose of study drug, had a baseline, and at least one post baseline value.|||percentage of participants|||Number
2577448|NCT02438826|Secondary|Percentage of Participants With a 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks|A 50% responder is any participant who has a ≥50% reduction from baseline in the weekly number of cluster headache attacks in a 14-day interval: Weeks 1/2, Weeks 3/4, Weeks 5/6, Weeks 7/8, Weeks 9/10, and Weeks 11/12. Mean percentage of participants is derived from the average of weeks 1/2 to weeks 11/12 from generalized linear mixed model repeated measures method with treatment, sex, verapamil use, week, treatment by week, and baseline as fixed effects.|Baseline, Week 1 through Week 12|All randomized participants who received at least 1 dose of study drug, and had baseline and at least 1 post baseline value.|||percentage of participants||Standard Error|Mean
2577470|NCT02438540|Primary|Serotonin|changes in Serotonin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||ng/ml||Standard Deviation|Mean
2577449|NCT02438826|Primary|Overall Mean Change From Baseline in Weekly Cluster Headache Attack Frequency|Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary, Baseline and 12 weeks of daily data during double-blind treatment phase will be converted into 14-calendar day intervals: the baseline 14-day interval, Weeks 1/2, 3/4, 5/6, 7/8, 9/10, and 11/12. Next, the biweekly interval results were adjusted to 7-day (weekly) interval in order to report the outcome as weekly frequency. Overall mean change from baseline is derived from mixed model repeated measures (MMRM) analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, verapamil use, pooled investigative site, week, baseline, and treatment by week as fixed effects.|Baseline, Week 1 through Week 12|All randomized participants who received at least 1 dose of study drug, and had baseline and at least one post baseline value.|||cluster headache attacks per week||Standard Error|Least Squares Mean
2577450|NCT02438813|Secondary|Change From Baseline in the Submental Skin Laxity Scale (SMSLG)|"SMSLG assessment was based on clinical evaluation and palpation of the submental area. The SMSLG scale incorporates 3 features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds).~Grade 1 (none): no or minimal superficial wrinkling, skin well apposed to deeper neck structures, no skin redundancy [no skin draping or skin sagging]; Grade 2 (mild): mild superficial wrinkling, skin well apposed to deeper neck structures, minimal skin redundancy [slight skin draping and sagging]; Grade 3 (moderate): may have mild to moderate superficial wrinkling, skin has mild to moderate separation from deeper neck structures, moderate skin redundancy [moderate skin draping and skin sagging]; Grade 4 (severe): mild to marked superficial wrinkling, loose skin separated from deeper neck structures, marked skin redundancy [marked skin draping and sagging]. A negative change from Baseline indicates improvement."|Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)|Full Analysis Set included all enrolled participants with a baseline visit and at least one post-baseline visit. Participants may have received more than one treatment. Number analyzed is the number of participants with data available for this outcome measure at the given time-point.|||score on a scale||Standard Deviation|Mean
2577451|NCT02438813|Secondary|Change From Baseline in the Patient Self-Perception of Age (SPA)|The participant rated their facial age in years at Baseline and at the End of Treatment Visit by answering the question: How many years difference compare to your actual age? A negative number indicates younger and a positive number indicates older. A negative change from Baseline indicates an improvement.|Baseline (Day 1) to End of Treatment Visit (Up to 18 Months)|Full Analysis Set included all enrolled participants with a baseline visit and at least one post-baseline visit. Participants may have received more than one treatment. Number analyzed is the number of participants with data available for this outcome measure at the given time-point.|||years||Standard Deviation|Mean
2577452|NCT02438813|Secondary|Change From Baseline in the Subject Self Rating Scale (SSRS)|"The participant was asked to answer the question: Considering your appearance in association with your face and chin, how satisfied do you feel with your appearance at the present time? using a 7-point scale: 0=Extremely dissatisfied, 1=Dissatisfied, 2=Slightly dissatisfied, 3=neither satisfied nor dissatisfied, 4=Slightly satisfied, 5=Satisfied, and 6=Extremely satisfied. A positive change from Baseline indicates improvement."|Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)|Full Analysis Set included all enrolled participants with a baseline visit and at least one post-baseline visit. Participants may have received more than one treatment. Number analyzed is the number of participants with data available for this outcome measure at the given time-point.|||score on a scale||Standard Deviation|Mean
2577453|NCT02438813|Secondary|Change From Baseline in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.|Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)|Full Analysis Set included all enrolled participants with a baseline visit and at least one post-baseline visit. Participants may have received more than one treatment. Number analyzed is the number of participants with data available for this outcome measure at the given time-point.|||score on a scale||Standard Deviation|Mean
2577454|NCT02438813|Secondary|Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0 to 4) with 0=No chin fat at all, 1=A slight amount of chin fat, 2=A moderate amount of chin fat, 3=A large amount of chin fat, and 4=A very large amount of chin fat. A negative change from Baseline indicates improvement."|Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment Visit (Up to 18 Months)|Full Analysis Set included all enrolled participants with a baseline visit and at least one post-baseline visit. Participants may have received more than one treatment. Number analyzed is the number of participants with data available for this outcome measure at the given time-point.|||score on a scale||Standard Deviation|Mean
2577455|NCT02438813|Secondary|Change From Baseline in the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)|The CR-SMFRS is based on the investigator's clinical evaluation of the participant's chin and neck area using a 5-point ordinal scale (0 to 4) with 0=Absent Submental Convexity: no localized submental fat evident; 1=Mild Submental Convexity: minimal, localized submental fat; 2=Moderate Submental Convexity: prominent, localized submental fat; 3=Severe Submental Convexity; a marked amount of chin fat; and 4=Extreme Submental Convexity: marked, localized submental fat. A negative change from Baseline indicates improvement.|Baseline (Day 1) to the Follow-up Visit (Up to 9 Months) and Baseline to End of Treatment (EOT) Visit (Up to 18 Months)|Full Analysis Set included all enrolled participants with a baseline visit and at least one post-baseline visit. Participants may have received more than one treatment. Number analyzed is the number of participants with data available for this outcome measure at the given time-point.|||score on a scale||Standard Deviation|Mean
2577502|NCT02437903|Other Pre-specified|Subject's Satisfaction With Temple Appearance|Subject's Satisfaction with Temple Appearance|Baseline, month 1, month 3, month 6, month 9, and Month 12|All subjects with data for this outcome measure|||Participants|||Count of Participants
2577457|NCT02438787|Secondary|Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20|The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Missing data were imputed using early escape rule (consider non-responder at Week 20 and 24).|Baseline, Week 4, 8, 12, 16 and 20|Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' (number analyzed) signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2577458|NCT02438787|Secondary|Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20|BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), morning stiffness(MS) (2 questions: duration and severity). Each question is an easy to answer 10 cm visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question related to MS duration: 0(0 hours), 10(2 or more hours). In order to give each of 5 symptoms equal weight, mean of 2 questions about MS will be added to total of remaining 4 scores, final BASDAI score (ranging 0-10) is average of overall total score. Higher BASDAI score indicates more severe AS symptom. 50% improvement in response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).|Week 4, 8, 12, 16 and 20|Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2577459|NCT02438787|Secondary|Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20|ASAS 20 defined as improvement from baseline of >= 20% and with an absolute improvement from baseline of 1 on a 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in the potential remaining domain. ASAS20 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).|Week 4, 8, 12, 16 and 20|Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2577460|NCT02438787|Secondary|Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20|ASAS 40 defined as improvement from baseline >= 40% and with an absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).|Week 4, 8, 12, 16 and 20|Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2577461|NCT02438787|Secondary|Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20|ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*total back pain) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058* duration of morning stiffness) + (0.579*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Inactive disease is defined as an ASDAS score <1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non- responders).|Week 4, 8, 12, 16 and 20|Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2577462|NCT02438787|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24|Change from baseline in hsCRP was reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).|Baseline, Week 4, 8, 12, 16, 20 and 24|Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants analyzed for this endpoint at specific timepoints.|||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2577471|NCT02438540|Primary|Resistin|Changes in Resistin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||ng/ml||Standard Deviation|Mean
2577463|NCT02438787|Secondary|Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score-C Reactive Protein (ASDAS-CRP) Inactive Disease (<1.3) at Week 24|ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*total back pain) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058* duration of morning stiffness) + (0.579*Ln(CRP+1). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Inactive disease is defined as an ASDAS score <1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responder).|Week 24|Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2577464|NCT02438787|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Week 24|The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Missing data were imputed using early escape rule (consider non-responder at Week 20 and 24).|Baseline and Week 24|Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this endpoint.|||Units on a scale||Standard Deviation|Mean
2577465|NCT02438787|Secondary|Percentage of Participants Who Achieved at Least a 50 Percent (%) Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24|BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), morning stiffness(MS) (2 questions: duration and severity). Each question is an easy to answer 10 cm visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question related to MS duration: 0(0 hours), 10(2 or more hours). In order to give each of 5 symptoms equal weight, mean of 2 questions about MS will be added to total of remaining 4 scores, final BASDAI score (ranging 0-10) is average of overall total score. Higher BASDAI score indicates more severe AS symptom. 50% improvement in response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).|Week 24|Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2577466|NCT02438787|Secondary|Percentage of Participants Who Achieved an ASAS 20 Response at Week 24|ASAS 20 defined as improvement from baseline of >= 20% from baseline and with an absolute improvement from baseline of 1 on a 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in the potential remaining domain. ASAS20 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).|Week 24|Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2577467|NCT02438787|Primary|Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24|ASAS 40 defined as improvement from baseline of greater than or equal to (>=) 40% and with an absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI(self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI(non responder imputation)] (missing responses at post baseline visit imputed as non-responder).|Week(W) 24|Modified-FAS included FAS population, excluding who discontinued study agent prior to W24 due to trial termination,not had efficacy assessments at W24,but not excluding participants who met EE at W16/ had treatment failure prior to W24.Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2577468|NCT02438540|Secondary|HOMA-IR|Changes of IR was calculated by the homeostasis model (HOMA-IR), proposed by Matthews et al. HOMA-IR = (fasting insulin (mmol/L) × fasting glucose (µIU/ml))/22•5. Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||units on a scale||Standard Deviation|Mean
2577469|NCT02438540|Secondary|Body Mass Index (BMI)|change of BMI. Body height was measured to an accuracy of +/-0.1cm. BMI was calculated by dividing weight (kg) into height (squared m²).|baseline, week 3||||Kg/m²||Standard Deviation|Mean
2577472|NCT02438540|Primary|Glucagon-like Peptide-1 (GLP-1)|changes in GLP-1 blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||mmol/L||Standard Deviation|Mean
2577473|NCT02438540|Primary|Adiponectin|Changes in Adiponectin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||µg/ml||Standard Deviation|Mean
2577474|NCT02438540|Primary|Leptin|changes in Leptin blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||ng/ml||Standard Deviation|Mean
2577475|NCT02438540|Primary|Ceramides|Changes in ceramides blood level, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||g/dl||Standard Deviation|Mean
2577476|NCT02438540|Primary|High Density Lipoprotein Cholesterol (HDLc)|HDLc changes, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||mmol/L||Standard Deviation|Mean
2577477|NCT02438540|Primary|Low Density Lipoprotein Cholesterol (LDLc)||baseline, week 2, week 3||||mmol/L||Standard Deviation|Mean
2577478|NCT02438540|Primary|Triglyceride (TG)||baseline, week 2, week 3||||mmol/L||Standard Deviation|Mean
2577479|NCT02438540|Primary|Free Fatty Acids (FFAs)|Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||mmol/L||Standard Deviation|Mean
2577480|NCT02438540|Primary|C-reaction Protein (CRP)|CRP blood markers changes; Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||mg/dl||Standard Deviation|Mean
2577481|NCT02438540|Primary|Tumor Necrosis Factor-α (TNF-α)|Blood markers changes in TNF α, were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||Pg/ml||Standard Deviation|Mean
2577482|NCT02438540|Primary|Interleukin-6 (IL-6)|IL-6 changes, IL-6 were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||Pg/dl||Standard Deviation|Mean
2577483|NCT02438540|Primary|Fasting Insulin (FINS)|change of FINS,Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||µIU/ml||Standard Deviation|Mean
2577484|NCT02438540|Primary|Fasting Blood Sugar (FBS)|changes FBS, Blood markers were calculated by measuring them after drawing 10 ml of blood from cubital vein in each patient, after 8 hours of overnight fasting and before treatment; Blood was collected three times during the study (at the beginning, at the 5th time, and at the end), from groups, using standard range and ELISA diagnostic kits (Biomatik USA LLC, www.biomatik.com), and clinical assessments and measurements undertaken after 3 weeks. Readings/assessment was performed at 3 weeks.|baseline, week 2, week 3||||mmol/L||Standard Deviation|Mean
2577485|NCT02438540|Primary|Body Weight|The effect of Metformin and acupuncture combined therapy on weight loss (Change from baseline in body weight), body weight was measured while the subjects were dressed in light clothing after an overnight fasting and by a standard scale to an accuracy of +/-0.1 kg. All measures were recorded by one assessment, at baseline before the first time treatment, and before the last time treatment at week 3.|baseline, week 3||||kg||Standard Deviation|Mean
2577486|NCT02438423|Secondary|Percentage of Subjects Achieving Seroconversion Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff).|Seroconversion is defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer ≥1:40, or a pre-vaccination HAI titer ≥1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer.|At Day 28||||percentage of subjects who seroconverted||95% Confidence Interval|Number
2577487|NCT02438423|Secondary|Percentage of Subjects Achieving Seroprotection (Defined as a HAI Antibody Titer of 1:40 or Greater) Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff).||At Day 28||||percentage of subjects (seroprotected)||95% Confidence Interval|Number
2577488|NCT02438423|Secondary|Geometric Mean Titer (GMT) of HAI Antibody Approximately 28 Days Following Receipt of IIV Delivered by Microneedle Patch or by Hypodermic Needle (Both Vaccines Administered by Study Staff).||At Day 28||||HAI Antibody Titers (GMT)||95% Confidence Interval|Geometric Mean
2577489|NCT02438423|Primary|Occurrence of Grade 3 Solicited or Unsolicited Adverse Events From D0 Until D28 (+/- 2 Days) After Study Product Administration.||From Day 0 until Day 28||||Grade 3 adverse events|||Number
2577490|NCT02438423|Primary|Occurrence of Study Product-related Serious Adverse Events From D0 Until D180 (+/- 14 Days) After Study Product Administration.||From Day 0 until Day 180||||Serious adverse events|||Number
2577491|NCT02438423|Primary|Occurrence of Solicited Injection Site and Systemic Reactogenicity on the Day of Study Product Administration Through 7 Days After Administration.|Safety will be measured by the occurrence of solicited injection site and systemic reactogenicity on the day of study product administration through 7 days after, and serious adverse events (SAEs) and new-onset chronic medical conditions through 180 days after study product administration. Local and systemic reactions were graded using an Injection Site Reaction table listing local reactions (e.g., swelling, erythema, etc.) and grade levels from 0 to 4 for each local reaction, a General Adverse Reaction table listing systemic reactions (e.g., fatigue, myalgia, etc.) and grade levels from 0 to 4 for each systemic reaction, and a Clinical Adverse Event Grading Scale (grades 1-4) for safety labs. In all tables, the higher the grade, the worse the adverse event.|From Day 0 through Day 8||||Reactions|||Number
2577492|NCT02438384|Secondary|Mean Physical Function Scores|Using a measure of higher-level physical function based on walking, climbing stairs, and carrying bags - scores range from 0 to 12 with higher score indicating higher function.|30 days after ED visit||||score on a scale||Standard Deviation|Mean
2577493|NCT02438384|Secondary|Average Overall Pain at One Month|"Determined using 0-10 numerical rating scale to answer the question What is the average amount of pain you have experienced over the last week on a scale of 0-10. where 0 means no pain and 10 means pain as severe as it could possibly be."|30 days after ED visit||||score on a scale||Standard Deviation|Mean
2577494|NCT02438384|Secondary|Number of Participants Experiencing Medication Side Effects|"Patients were asked if they experienced any of the following side effects: fatigue, drowsiness, trouble sleeping, trouble thinking, dizziness, unsteadiness, nausea, vomiting, constipation, abdominal pain, black or bloody stool, trouble urinating, loss of appetite, itching or shortness of breath. Patients were also queried about any other side effects they had that were not on the list.~Participants reporting at least one side effect were included."|30 days after ED visit||||Participants|||Count of Participants
2577495|NCT02438384|Primary|Change in Pain Score|Change in Pain from emergency department (ED) visit to 30 day follow-up phone call will be measured by calculating the difference between the maximum pain score in the ED and the patient reported average overall pain severity in the past week using the 0-10 numeric rating scale for both measures.Change in pain will be reported as a negative number if the pain decreases (i.e., 10 to 8 = -2). Higher scores indicate a worse outcome.|ED visit and 30 days post-ED visit||||score on a scale||Standard Deviation|Mean
2577496|NCT02438280|Secondary|Final Alignment Scores of the Upper and Lower Incisors|Final alignment was measured using Little's incisor irregularity index. This index sums the displacement of the contact points of the anterior teeth, to produce a millimetric number. The lower the score, the more perfect the alignment.|6 months|Final incisor irregularity, measured in millimeters|||Little's irregularity index (mm)||Standard Deviation|Mean
2577497|NCT02438280|Primary|Ability to Complete Treatment Aligners in Conjunction With an Active and Placebo Vibration Device (AcceleDent® Aura)|The outcome was the ability to complete the initial set of aligners using either an active vibration device or a placebo vibration device. Regardless of the group assignment, patients were asked to change their aligners each week, and we tracked the percentage that were able to complete their series of aligners.|6 months|The outcome was the ability to complete the initial set of aligners|||Participants|||Count of Participants
2577498|NCT02438137|Secondary|Mean Change in Serum Cytokine Levels (Mean Difference of Log-transformed Values)|Levels of markers in the blood known as cytokines (measured in picograms per milliliter) were measured on a monthly basis from Month 0 (baseline) to Month 4. The outcome is the mean difference in cytokine level from baseline to month 4 (mean level at Month 4 - mean level at Baseline). Values were log-transformed for normality, prior to analysis.|Month 0 to Month 4|Cytokine analyses were conducted for those participants who completed the study and had interpretable Month 4 PSG results. Among this group, 3 participants did not have usable Month 4 blood specimens for this analysis. Thus, the mean difference in cytokine levels was calculated for 47 participants.|||picograms/milliliter (log-transformed)||Standard Deviation|Mean
2577499|NCT02438137|Primary|Mean Change in Apnea Severity as Measured by the Respiratory Disturbance Index (RDI)|For the 50 participants who had interpretable month 4 polysomnography (PSG) data available, mean change in sleep apnea severity, as measured by the mean change in respiratory disturbance index (RDI) between baseline (Month 0) PSG and Month 4 PSG, was calculated. The RDI represents the total number of apneas, hypopneas and respiratory-related arousals per hour of sleep.|Month 0 to Month 4|65 participants were randomized. 14 participants withdrew from the study or were lost to followup. 51 completed study activities. 50 (35 DMF and 15 placebo) both completed the study and had an interpretable Month 4 PSG. One participant's Month 4 PSG was uninterpretable, thus the RDI from this participant could not be included in the final analysis.|||respiratory events/hour||Standard Deviation|Mean
2577500|NCT02437903|Other Pre-specified|Number of Participants With Specific Site Treatment Responses|Site treatment response reported by subject on diary day 0-14 post initial injection and touch-up injections|Day 14|Total number of subjects that reported symptom|||Participants|||Count of Participants
2577503|NCT02437903|Secondary|Investigator's Satisfaction With the Appearance of the Temporal Regions|Graded level of satisfaction with the current appearance of the temporal region making certain that the investigator is looking at the patient's right side and not the investigator's right side.|Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12|All subjects with data for this outcome measure|||Participants|||Count of Participants
2577504|NCT02437903|Primary|Frontal Temporal Fossa Rating Scale|Graded severity of the temporal line of the frontal bone (TLFB) using the Frontal Temporal Fossa Rating Scale: (these will have a picture assigned to each score.|Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12|All subjects with data for for this outcome measure|||Participants|||Count of Participants
2577505|NCT02437890|Secondary|Number and Percentage of Subjects Who Were Treatment-emergent (TE) Anti-drug Antibody (ADA) Positive||From first administration of ALX-0061 up to and including follow-up|Safety Population|||Participants|||Count of Participants
2577506|NCT02437890|Secondary|Actual Values for Hemolytic Complement Component 50 (CH50) at Baseline, Week 24, and Week 48||At Baseline, Week 24, and Week 48|Safety Population|||unit(s)||Standard Error|Mean
2577507|NCT02437890|Secondary|Actual Values of Complement C4 Concentrations at Baseline, Week 24, and Week 48||At Baseline, Week 24, and Week 48|Safety Population|||mg/dL||Standard Error|Mean
2577508|NCT02437890|Secondary|Actual Values of Complement C3 Concentrations at Baseline, Week 24, and Week 48||At Baseline, Week 24, and Week 48|Safety Population|||mg/dL||Standard Error|Mean
2577509|NCT02437890|Secondary|Actual Values of Anti-double-stranded (ds) DNA Concentrations at Baseline, Week 24, and Week 48||at Baseline, Week 24, and Week 48|Safety Population|||IU/mL||Standard Error|Mean
2577510|NCT02437890|Secondary|Actual Values of Fibrinogen Concentrations at Baseline, Week 24, and Week 48||At Baseline, Week 24, and Week 48|Safety Population|||g/L||Standard Error|Mean
2577511|NCT02437890|Secondary|Actual Values of C-reactive Protein (CRP) Concentrations at Baseline, Week 24, and Week 48||At Baseline, Week 24, and Week 48|Safety Population|||nmol/L||Standard Error|Mean
2577512|NCT02437890|Secondary|Actual Values of Soluble Interleukin 6 Receptor (sIL-6R) Concentrations at Baseline, Week 24, and Week 48||At Baseline, Week 24, and Week 48|Safety Population|||ng/mL||Standard Error|Mean
2577513|NCT02437890|Secondary|ALX-0061 Serum Concentrations at Week 24 and Week 48||At Week 24 and Week 48|Safety Population|||µg/mL||Standard Deviation|Geometric Mean
2577514|NCT02437890|Secondary|Change From Baseline in CLASI Damage Score at Week 12, Week 24 and Week 48|"CLASI Damage is scored based on dyspigmentation and scarring. Evaluation of dyspigmentation and scarring is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area (dyspigmentation: 0=absent, 1=present; scarring: 0=absent, 1=scarring, 2=severely atrophic scarring or panniculitis). Subjects are also asked whether dyspigmentation due to SLE lesions usually remains visible for >12 months, which is considered permanent and results in doubling of the dyspigmentation score. Scarring alopecia is scored as follows: 0=absent, 3=1 quadrant, 4=2 quadrants, 5=3 quadrants, 6=affects the whole skull. Total score ranges from 0-56, with higher scores indicating more damaged skin.~Mean changes from baseline were derived from an ANCOVA model with treatment as factor and baseline CLASI Damage Score and geographic region as covariates. Negative change = improvement."|At Week 12, Week 24 and Week 48|mITT Population|||score||Standard Error|Mean
2577515|NCT02437890|Secondary|Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score at Week 12, Week 24 and Week 48|"CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area (erythema: 0=absent, 1=pink, 2=red, 3=dark red; scale: 0=absent, 1=scale, 2=verrucous/hypertrophic). Mucous membrane involvement and acute hair loss are scored based on the presence (=1) or absence (=0).~Nonscarring alopecia is scored as 0=absent, 1=diffuse/non-inflammatory, 2=focal or patchy in 1 quadrant, 3=focal or patchy in >1 quadrant. The total score ranges from 0-70, with higher scores indicating more severe skin disease.~Mean changes from baseline were derived from an ANCOVA model with treatment as factor and baseline CLASI Activity Score and geographic region as covariates. Negative change = improvement"|At Week 12, Week 24 and Week 48|mITT Population|||score||Standard Error|Mean
2577516|NCT02437890|Secondary|Change From Baseline in 28 Joint Count Tenderness (TJC28) Score at Week 24 and Week 48|Twenty-eight joints are assessed for tenderness (a score of 1 for a joint denotes a presence of tenderness). The sum is derived to create a total score (ranging from 0 to 28; where the highest score indicate all 28 joints are tender). Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline TJC28 Score and geographic region as covariates. A negative change denotes and improvement.|At Week 24 and Week 48|mITT Population|||score||Standard Error|Mean
2577517|NCT02437890|Secondary|Change From Baseline in 28 Joint Count Swollenness (SJC28) Score at Week 24 and Week 48|Twenty-eight joints are assessed for swollenness (a score of 1 for a joint denotes a presence of swollenness). The sum is derived to create a total score (ranging from 0 to 28; where the highest score indicate all 28 joints are swollen). Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline SJC28 Score and geographic region as covariates. A negative change denotes an improvement.|At Week 24 and Week 48|mITT Population|||score||Standard Error|Mean
2577518|NCT02437890|Secondary|Change From Baseline in Mental Component Scores of SF-36 at Week 24 and Week 48|"The Short Form (36) Health Survey (SF-36) consists of 36 items that can be summarized into 8 domains: physical functioning, role limitations due to physical health problems (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional problems (role-emotional), and mental health. Two summary measures, the physical component summary and the mental component summary, can be derived based on these domain scores. Each score is directly transformed into a 0-100 score on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.~Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline SF-36 Score and geographic region as covariates. A positive change denotes an improvement."|At Week 24 and Week 48|mITT Population|||score||Standard Error|Mean
2577519|NCT02437890|Secondary|Change From Baseline in Physical Component Scores of Short Form (36) Health Survey (SF-36) at Week 24 and Week 48|"The Short Form (36) Health Survey (SF-36) consists of 36 items that can be summarized into 8 domains: physical functioning, role limitations due to physical health problems (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional problems (role-emotional), and mental health. Two summary measures, the physical component summary and the mental component summary, can be derived based on these domain scores. Each score is directly transformed into a 0-100 score on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.~Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline SF-36 Score and geographic region as covariates. A positive change denotes an improvement."|At Week 24 and Week 48|mITT Population|||score||Standard Error|Mean
2577520|NCT02437890|Secondary|Number and Percentage of Subjects Who Discontinued Prednisone (or Equivalent) by Week 48 Without Experiencing a Severe Flare|Number and percentage of subjects who discontinued Prednisone (or equivalent) by Week 48 without experiencing a BILAG-2004-defined or mSFI-defined severe flare|Up to and including Week 48|mITT Population|||Participants|||Count of Participants
2577521|NCT02437890|Secondary|Number and Percentage of Subjects Whose Daily Dose of Steroids Was Reduced Without Severe Flares During Weeks 40-48|Number and percentage of subjects whose prednisone equivalent dose was >7.5 mg/day at baseline and reduced to ≤7.5 mg/day during Weeks 40-48 without experiencing a BILAG-2004-defined or mSFI-defined severe flare after the first prednisone equivalent dose decrease.|Between Week 40 and Week 48|mITT Population|||Participants|||Count of Participants
2577522|NCT02437890|Secondary|Percent Change From Baseline in Daily Dose of Steroids at Week 24 and Week 48|Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline prednisone equivalent total daily dose and geographic region as covariates|At Week 24 and Week 48|mITT Population|||percentage||Standard Error|Mean
2577523|NCT02437890|Secondary|Number and Percentage of Subjects Experiencing Severe Flares According to mSLEDAI-2K Flare Index (mSFI) From Baseline to Week 24 and Week 48||From Baseline to Week 24 and Week 48|mITT Population|||Participants|||Count of Participants
2577524|NCT02437890|Secondary|Number and Percentage of Subjects Experiencing Severe Flares According to BILAG-2004 Flare Index From Baseline to Week 24 and Week 48||From Baseline to Week 24 and Week 48|mITT Population|||Participants|||Count of Participants
2577525|NCT02437890|Secondary|Number of and Percentage Treatment Failures From Baseline to Week 24 and Week 48|Defined as non-protocol allowed increase in steroid dose, start i.v. or i.m. steroids, or start or increase of immunosuppressant|From Baseline to Week 24 and Week 48|mITT Population|||Participants|||Count of Participants
2577526|NCT02437890|Secondary|Change From Baseline in Creatinine Clearance Estimation (eGFR) at Week 24 and Week 48|Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline eGFR and geographic region as covariates|At Week 24 and Week 48|mITT Population|||mL/min/1.73m2||Standard Error|Mean
2577527|NCT02437890|Secondary|Change From Baseline in Serum Creatinine at Week 24 and Week 48|Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline serum creatinine and geographic region as covariates|At Week 24 and Week 48|mITT Population|||umol/L||Standard Error|Mean
2577528|NCT02437890|Secondary|Number of Subjects Who Were Treatment-emergent Urine Sediment Positive at Week 24 and Week 48|Efficacy Laboratory Parameters (Urinalysis) - Active Urine Sediment Number of subjects who were urine sediment negative at Baseline, but positive at Week 24 and Week 48, respectively.|At Week 24 and Week 48|mITT Population|||Participants|||Count of Participants
2577529|NCT02437890|Secondary|Change From Baseline in Proteinuria at Week 24 and Week 48|Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline proteinuria and geographic region as covariates|At Week 24 and Week 48|mITT Population|||g/mol||Standard Error|Mean
2577530|NCT02437890|Secondary|Change From Baseline in Patient's Global Assessment at Week 24 and Week 48|"The subject makes a mark between 0 (very good) and 100 mm (very bad) on the VAS to indicate how the subject is doing, while considering all the ways SLE affects him/her.~Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline Patient's Global Assessment and geographic region as covariates.~A negative change from baseline reflects an improvement."|At Week 24 and Week 48|mITT Population|||score on a scale||Standard Error|Mean
2577531|NCT02437890|Secondary|Change From Baseline in Physician's Global Assessment (PGA) at Week 24 and Week 48|"The physician makes a mark between 0 (no disease) and 100 mm (severe disease) on the visual analogue scale (VAS) to indicate disease activity (independent of the subject's self-assessment).~Mean changes from baseline were derived from an analysis of covariance (ANCOVA) model with treatment as factor and baseline PGA score and geographic region as covariates.~A negative change from baseline reflects an improvement."|At Week 24 and Week 48|mITT Population|||score on a scale||Standard Error|Mean
2577532|NCT02437890|Secondary|Number and Percentage of Subjects With Persistent Minimal or no Activity in 9 Organ Systems According to BILAG-2004 Systems Tally at Week 24 and Week 48||At Week 24 and Week 48|mITT Population|||Participants|||Count of Participants
2577533|NCT02437890|Secondary|Number and Percentage of Subjects With BILAG-2004 Normal Improvement in Musculoskeletal System at Week 24 and Week 48|"An improvement is defined as an A score at Baseline improved to B/C/D, or a B score improved to C or D.~Only subjects with non-missing BILAG-2004 who had at least one A or B score at Baseline were assessed for this endpoint"|At Week 24 and Week 48|mITT Population|||Participants|||Count of Participants
2577534|NCT02437890|Secondary|Number and Percentage of Subjects With BILAG-2004 Normal Improvement in Mucocutaneous System at Week 24 and Week 48|"An improvement is defined as an A score at Baseline improved to B/C/D, or a B score improved to C or D.~Only subjects with non-missing BILAG-2004 who had at least one A or B score at Baseline were assessed for this endpoint"|At Week 24 and Week 48|mITT Population|||Participants|||Count of Participants
2577565|NCT02437487|Secondary|Time to Recurrence of CDI|Kaplan-Meier estimate of median number of days to recurrence|Recurrence of CDI up to 24 weeks after treatment.|Intention to Treat (ITT) Population|||days||95% Confidence Interval|Median
2577566|NCT02437487|Primary|Number of Subjects With CDI Recurrence||8 weeks after treatment.|Intention-To-Treat (ITT) Population|||participants|||Number
2577535|NCT02437890|Secondary|BILAG-2004 Total Score at Baseline, Week 24 and Week 48|"The British Isles Lupus Assessment Group 2004 (BILAG-2004) is a comprehensive composite clinical index that has been developed based on the principle of a physician's intention to treat using a nominal consensus approach. In the index, the nine systems (not organs) considered are: constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, renal, ophthalmic and hematological. Disease activity in each of the nine systems is categorized into five levels: grades A (= severe disease activity requiring systemic high dose oral corticosteroids, i.v. pulse corticosteroids, etc.) to E (= system never involved).~BILAG total score is derived by assigning the following value to each grade and summing the sores over all organ systems:~A = 12, B = 8, C = 1, D/E = 0. The total score ranges from 0-108, with 108 representing high disease activity in all 9 systems requiring high doses of corticosteroids, starting/increasing immunosuppressive drugs, etc."|At Baseline, Week 24 and Week 48|mITT Population|||score||Standard Error|Mean
2577536|NCT02437890|Secondary|Number and Percentage of Subjects With BILAG-2004 Enhanced Improvement at Week 24 and Week 48|Enhanced improvement: all A scores at baseline improved to B/C/D, and all B scores improved to C or D and no worsening between consecutive visits from baseline up to the considered visit Only subjects with non-missing BILAG-2004 who had at least one A or B score at Baseline were assessed for this endpoint|At Week 24 and Week 48|mITT Population|||Participants|||Count of Participants
2577537|NCT02437890|Secondary|Number and Percentage of Subjects With BILAG-2004 Normal Improvement at Week 24 and Week 48|"Normal Improvement: all A scores at baseline improved to B/C/D, and all B scores improved to C or D.~Only subjects with non-missing BILAG-2004 who had at least one A or B score at Baseline were assessed for this endpoint"|At Week 24 and Week 48|mITT Population|||Participants|||Count of Participants
2577538|NCT02437890|Secondary|Change From Baseline in Modified Systemic Lupus Erythematosus Disease Activity Index 2000 (mSLEDAI-2K) Score at Week 24 and Week 48|The Systemic Lupus Erythematosus Disease Activity Index 2000 is a 1-page weighted score for 24 items (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, etc). The manifestations felt to be most commonly contributing to disease activity are included and scored based on the presence (= 1 multiplied by weight) or absence (= 0) within 30 days prior to the evaluation. The total score ranges from 0-105 (= sum of individual scores), with 105 being higher disease activity. mSLEDAI-2K derives from the standard index by omitting low complement. Mean changes from baseline were derived from an ANCOVA model with treatment as factor and baseline mSLEDAI-2K Score and geographic region as covariates. A negative change from baseline reflects an improvement.|At Week 24 and Week 48|mITT Population|||score||Standard Error|Mean
2577539|NCT02437890|Secondary|Number and Percentage of Subjects With mSRI-8 Response at Week 24 and Week 48.|"The mSRI-8 criteria for response are:~mSLEDAI-2K: ≥ 8 point reduction~BILAG-2004: no new A domain score and no more than 1 new increase to B domain score~PGA: no worsening (< 10% increase from Baseline) Only subjects with Baseline mSLEDAI-2K ≥ 8 were considered for the derivation of that endpoint.~Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation."|At Week 24 and Week 48|mITT Population|||Participants|||Count of Participants
2577540|NCT02437890|Secondary|Number and Percentage of Subjects With mSRI-7 Response at Week 24 and Week 48|"The mSRI-7 criteria for response are:~mSLEDAI-2K: ≥ 7 point reduction~BILAG-2004: no new A domain score and no more than 1 new increase to B domain score~PGA: no worsening (< 10% increase from Baseline) Only subjects with Baseline mSLEDAI-2K ≥ 7 were considered for the derivation of that endpoint.~Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation."|At Week 24 and Week 48|mITT Population|||Participants|||Count of Participants
2577541|NCT02437890|Secondary|Number and Percentage of Subjects With mSRI-6 Response at Week 24 and Week 48|"The mSRI-6 criteria for response are:~mSLEDAI-2K: ≥ 6 point reduction~BILAG-2004: no new A domain score and no more than 1 new increase to B domain score~PGA: no worsening (< 10% increase from Baseline) Only subjects with Baseline mSLEDAI-2K ≥ 6 were considered for the derivation of that endpoint.~Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation"|At Week 24 and Week 48|mITT Population|||Participants|||Count of Participants
2577542|NCT02437890|Secondary|Number and Percentage of Subjects With mSRI-5 Response at Week 24 and Week 48|"The mSRI-5 criteria for response are:~mSLEDAI-2K: ≥ 5 point reduction~BILAG-2004: no new A domain score and no more than 1 new increase to B domain score~PGA: no worsening (< 10% increase from Baseline) Only subjects with Baseline mSLEDAI-2K ≥ 5 were considered for the derivation of that endpoint.~Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation."|At Week 24 and Week 48|mITT Population|||Participants|||Count of Participants
2577543|NCT02437890|Secondary|Number and Percentage of Subjects With Modified Systemic Lupus Erythematosus Responder Index (mSRI-4) Response at Week 24 and Week 48|"The composite index mSRI-4 enables quantification of decrease and increase in disease activity in a broad spectrum of manifestations thereby offering a comprehensive assessment of SLE disease status. mSRI combines advantages from 3 validated measurement tools. The mSRI-4 criteria for response are:~modified SLE disease activity index 2000 (mSLEDAI-2K): ≥ 4 point reduction (covers global disease improvement),~British Isles Lupus Assessment Group 2004 (BILAG-2004): no new A domain score and no more than 1 new increase to B (covers organ-specific disease improvement),~Physician's Global Assessment (PGA) (is used as validity and safety net for items that were not addressed by the other two indices): < 10% increase from Baseline (no worsening) When all 3 criteria are met, the subject is a mSRI-4 responder at that time point.~Subjects who were treatment failures or discontinued from treatment were considered non-responder after treatment failure/discontinuation."|At Week 24 and Week 48|mITT Population|||Participants|||Count of Participants
2577544|NCT02437890|Secondary|Number and Percentage of Subjects With mBICLA Response at Week 24 and Week 48|Number and percentage of mBICLA responders at Week 24 and Week 48|At Week 24 and Week 48|mITT Population|||Participants|||Count of Participants
2577567|NCT02437409|Secondary|No. of Passages Needed to Reach the Final TICI Score With pREset||during intervention, up to 3 hr|100 patients harboured 109 vessel occlusions|||passes|vessel occlusions|Standard Deviation|Mean
2583398|NCT02367794|Secondary|PFS as Determined by the Investigator Using RECIST v1.1 in the TC1/2/3 or IC1/2/3 Population||Up to approximately 30 months after first participant enrolled||2020-10-31|10/2020||||
2577545|NCT02437890|Primary|Number and Percentage of Subjects Who Achieved a Response at Week 24 According to the Modified British Isles Lupus Assessment Group (BILAG)-Based Composite Lupus Assessment (mBICLA) Score|"The primary endpoint was evaluated by determining if there was a dose-response relationship between the mBICLA response rate at Week 24 and the dose administered, using the Multiple Comparison Procedure - Modelling (MCP-Mod) methodology. The existence of several candidate parametric models was assumed and multiple comparison techniques were used to choose the model(s) most likely to represent the true underlying dose-response curve. The selected model could further be used to guide the choice of adequate doses.~mBICLA responders were defined as subjects who met all of the following criteria:~BILAG-2004 normal improvement: all A scores at Baseline improved to B, C or D, and all B scores improved to C or D.~No worsening in disease activity: no new BILAG-2004 A scores and ≤ 1 new increase to B.~No worsening of total mSLEDAI-2K score from Baseline.~No significant deterioration (< 10% worsening from Baseline) in PGA.~No treatment failure (including the premature"|At Week 24 visit|mITT Population - Non-response imputation (NRI)|||Participants|||Count of Participants
2577546|NCT02437864|Secondary|Patients' Lowest Pulse Oximetry Value Observed During Airway Placement||From anesthetic induction to intubation; an expected average of 10 minutes||||percentage of oxygenated hemoglobin||Inter-Quartile Range|Median
2577547|NCT02437864|Secondary|Number of Patients Whose Pulse Oximetry Falls Below 90% During Airway Placement||From anesthetic induction to intubation; an expected average of 10 minutes||||Participants|||Count of Participants
2577548|NCT02437864|Secondary|Number of Patients Requiring Intervention by Attending or Temporary Mask Ventilation During Airway Placement||From anesthetic induction to intubation; an expected average of 10 minutes||||Participants|||Count of Participants
2577549|NCT02437864|Secondary|Number of Patients Whose Pulse Oximetry Falls Below 95% During Airway Placement||From anesthetic induction to intubation; an expected average of 10 minutes||||Participants|||Count of Participants
2577550|NCT02437864|Primary|Time to First Event: Pulse Oximetry at 95%, or Successful Intubation|Prior to anesthesia induction, patients are ventilated to achieve pulse oximetry (SpO2) values near 100%. This outcome represents the elapsed time before successful intubation or pulse oximetry declining to 95%, whichever came first.|From anesthetic induction to whichever comes first: pulse oximetry falling to 95%, or successful intubation; an expected average of less than 10 minutes||||seconds||Inter-Quartile Range|Median
2577551|NCT02437669|Secondary|Score on Verbal Numeric Rating Scale|Pain was measured using the Verbal Numerical Rating Scale (VNRS). The VNRS is a self-reported measure of pain that is administered verbally by asking a patient to rate their pain on a scale from 0 to 10, with 0 representing no pain, and 10 representing maximum pain. More information about the VNRS in children can be found here: https://bit.ly/2VZ7aWU|1 hour|Decrease in pain score one hour after terminal dose of intranasal hydromorphone administered|||units on a scale||95% Confidence Interval|Mean
2577552|NCT02437669|Secondary|Number of Major Adverse Events|Oxygen desaturation, respiratory depression, hypotension, bradycardia, need for supplemental oxygen, bag-mask ventilation, airway support intervention, administration naloxone.|6 hours||||Major adverse events|||Number
2577553|NCT02437669|Secondary|Number of Minor Adverse Events|Lightheadedness, dizziness; confusion; sleepy, drowsy, tiredness; nausea; vomiting; itchiness, warm sensation; dry mouth; bad taste in mouth; rhinitis.|6 hours||||Minor adverse events|||Number
2577554|NCT02437669|Primary|Score on Faces Pain Scale - Revised|"Pain was measured using the Faces Pain Scale - Revised (FPS-R). The FPS-R is a self-reported measure of pain that is administered using a picture of 6 different faces lined up in a row, each face representing an escalating degree of pain intensity. The faces, starting from the left-most face and moving towards the right-most face, are scored 0, 2, 4, 6, 8 and 10. A score of 0 represents no pain, a score of 10 represents very much pain (i.e. maximum possible pain). More information about the FPS-R can be found here: https://bit.ly/2VPk8GM"|1 hour|Decrease in pain score one hour after terminal dose of intranasal hydromorphone administered|||units on a scale||95% Confidence Interval|Mean
2577555|NCT02437513|Other Pre-specified|Reported Subjective Rating of Comfort of the Device in the Larynx|In patient subjective measure (repeated) of pain score (1-10) and comfort level (questionnaire) at weeks 1,4,8,12|12 weeks|||||||
2577556|NCT02437513|Other Pre-specified|Change From Baseline of Quality of Life (QoL) Score|In patient QoL assessed at baseline and at 12 weeks using German standard QoL clinical questionnaire specifically for patients with swallowing dysfunction|12 weeks|||||||
2577557|NCT02437513|Other Pre-specified|Number of Participants With Reported Device Migration in the Larynx Post Implant|In patient change from baseline position of the device in the larynx of each patient assessed by endoscopy and/or other clinically appropriate methods (CT or video fluoroscopy) and recorded in migration direction and distance (cm)|1 weeks||||participants|||Number
2577558|NCT02437513|Secondary|Number of Participants With an Increase of Greater Than 1 on the Heyse-Moore Score|"In patient change from baseline score of dyspnea using Heyse-Moore (Dyspnea)score:~0 = None~= Mild, some difficulty~= Moderate Difficulty but can continue~= Severe difficulty, cannot continue"|1 weeks|Second enrolled patient did not reach the first data point, subj. was explanted prior first measurement.|||participants|||Number
2577559|NCT02437513|Secondary|Number of Reported Adverse Events|Analysis of the the rate and severity of reported system or procedure related adverse events as a measure of safety of the device in this patient population over a 12 week period|2 weeks||||AE reported|||Number
2577560|NCT02437513|Secondary|Number of Reported Adverse Events|Analysis of the reported system or procedure related adverse events using standard AE reporting form|at device implantation||||adverse events|||Number
2577561|NCT02437513|Primary|Change From Baseline Per Patient of Number and Severity of Aspiration Events|In patient change from baseline measurement of aspiration severity and frequency of events at weeks 1,4,8,and 12|12 weeks|First patient: Device was explanted within 48 hours after implantation - no Data could be collected Second Patient: Due to patient's non-compliance no data could be collected.Device was explanted within two weeks after implantation.||||||
2577562|NCT02437487|Secondary|Number of Subjects With CDI Recurrence||24 Weeks|Intention-to-Treat (ITT) Population|||Participants|||Count of Participants
2577563|NCT02437487|Secondary|Number of Subjects With CDI Recurrence||12 Weeks|Intention-to-Treat (ITT) Population|||Participants|||Count of Participants
2577564|NCT02437487|Secondary|Number of Subjects With CDI Recurrence||4 Weeks|Intention-to-Treat (ITT) Population|||Participants|||Count of Participants
2577568|NCT02437409|Secondary|Recanalization of the Target Vessel|"original Thrombolysis in Cerebral Infarction score (o-TICI) The TICI scale indicates perfusion of an occluded blood vessel, it is used in angiographic imaging.~Grade 0 = no perfusion Grade 1 = Penetration with minimal perfusion. The contrast material passes beyond the area of obstruction but fails to opacify the entire cerebral bed distal to the obstruction for the duration of the angiographic run, Grade 2a = Only partial filling (<2/3) of the entire vascular territory is visualized, Grade 2b = Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal, Grade 3 = complete perfusion."|at the end of intervention, up to 3 hr|100 patients harboured 109 vessel occlusions|||number of vessels|vessel occlusions||Number
2577569|NCT02437409|Secondary|Time From Groin Puncture to Recanalization||during intervention, up to 3 hr|All Patients|||minutes||Full Range|Median
2577570|NCT02437409|Secondary|Intracranial Hemorrhage (ICH)|Intracranial hemorrhage was assessed via imaging material (e.g. Digital Subtraction Angiography - DSA or CT) as forwarded by the clinical sites.|24 hr after treatment|All Patients|||patients|||Number
2577571|NCT02437409|Secondary|Neurological Condition of the Patient|"The National Institutes of Health Stroke Scale (NIHSS) is a commonly used measure to assess the severity of a stroke. All items are rated and scores are added at the end. A higher score corresponds to a more severe stroke. Assessed are:~Level of Conciousness (LOC) (0-3) 1a. LOC Questions (0-2) 1b. LOC Commands (0-2)~Best Gaze (0-2)~Visual (0-3)~Facial palsy (0-3)~Motor arm (0-4)~Motor leg (0-4)~Limb ataxia (0-2)~Sensory (0-2)~Best Language (0-3)~Dysarthria (0-2)~Extinction and Inattention (0-2)~CLASSIFICATION:~0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke~As published by ninds.nih.gov: http://www.ninds.nih.gov/doctors/NIH_Stroke_Scale.pdf"|24 to 72 hr after treatment|All Patients|||NIHSS score||Full Range|Median
2577572|NCT02437409|Primary|Neurological Condition of the Patient|"modified Rankin Scale (mRS)~Neurological Condition is measured by the Modified Rankin Scale (mRS). This scale ranges from 0 - 6:~0 = No symptoms at all;~= able to carry out all usual duties and activities;~= unable to carry out all previous activities, but able to look after own affairs without assistance;~= requiring some help, but able to walk without assistance;~= unable to walk without assistance and unable to attend to own bodily needs without assistance;~= bedridden, incontinent and requiring constant nursing care and attention;~= dead"|90 days after treatment|All Patients|||patients|||Number
2577573|NCT02437383|Other Pre-specified|Change in the Weekly Mean Pain Index After 9 Weeks of Treatment Stratified Per Number of COMT Valine Alleles at rs4680|"Weekly mean pain index computed as the arithmetic mean of daily pain index values during the week prior to randomization and prior to each study visit. Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = no pain and 100 = the most intense pain imaginable) multiplied by pain duration (0-100 percentage scale where percent = percent of waking day you had facial pain) as reported in the Daily Symptom Diary, divided by 100. The pain index range is from 0 to 100. A higher score means a worse outcome. The pain index was stratified per number of catechol-O-methyltransferase (COMT) valine alleles at single nucleotide polymorphism (SNP) rs4680."|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication, provided at least one post-baseline outcome measure, and had genotyping data for COMT rs4680.|||units on a scale||95% Confidence Interval|Least Squares Mean
2577574|NCT02437383|Other Pre-specified|Change in the Weekly Mean Pain Index After 9 Weeks of Treatment Stratified Per Number of COMT LPS Haplotypes|"Weekly mean pain index computed as the arithmetic mean of daily pain index values during the week prior to randomization and prior to each study visit. Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = no pain and 100 = the most intense pain imaginable) multiplied by pain duration (0-100 percentage scale where percent = percent of waking day you had facial pain) as reported in the Daily Symptom Diary, divided by 100. The pain index range is from 0 to 100. A higher score means a worse outcome. The pain index was stratified per number of catechol-O-methyltransferase (COMT) Low Pain Sensitive (LPS) haplotypes."|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication, provided at least one post-baseline outcome measure, and had genotyping data for COMT haplotypes.|||units on a scale||95% Confidence Interval|Least Squares Mean
2577575|NCT02437383|Secondary|Change in Heart Rate After 9 Weeks of Treatment|Average of 3 repeated measures taken with a 2-minute interval.|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||beats per minute||95% Confidence Interval|Least Squares Mean
2577576|NCT02437383|Secondary|Change in Diastolic Blood Pressure After 9 Weeks of Treatment|Average of 3 repeated measures taken with a 2-minute interval.|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||mm Hg||95% Confidence Interval|Least Squares Mean
2577577|NCT02437383|Secondary|Change in Systolic Blood Pressure After 9 Weeks of Treatment|Average of 3 repeated measures taken with a 2-minute interval.|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||mm Hg||95% Confidence Interval|Least Squares Mean
2577578|NCT02437383|Secondary|Change in Maximum Assisted Jaw Opening After 9 Weeks of Treatment|Measured at TMD exam. A higher value means a better outcome.|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||mm||95% Confidence Interval|Least Squares Mean
2577579|NCT02437383|Secondary|Change in Maximum Unassisted Jaw Opening After 9 Weeks of Treatment|Measured at TMD exam. A higher value means a better outcome.|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||mm||95% Confidence Interval|Least Squares Mean
2577580|NCT02437383|Secondary|Change in Pain-free Jaw Opening After 9 Weeks of Treatment|Measured at TMD exam. A higher value means a better outcome.|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||mm||95% Confidence Interval|Least Squares Mean
2577620|NCT02437318|Secondary|Overall Response Rate (ORR)|ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST 1.1.|Up to approximatly 36 months||2021-09-30|09/2021||||
2577581|NCT02437383|Secondary|Change in Pressure Pain Threshold at Lateral Epicondyle After 9 Weeks of Treatment|Pressure values, measured in kilopascals, from up to 5 experimental pressure stimuli, bilaterally applied to the area of lateral epicondyle, will be averaged to obtain a single pressure pain threshold value per anatomical site.|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||kPa||95% Confidence Interval|Least Squares Mean
2577582|NCT02437383|Secondary|Change in Pressure Pain Threshold at Trapezius Muscle After 9 Weeks of Treatment|Pressure values, measured in kilopascals, from up to 5 experimental pressure stimuli, bilaterally applied to the area of trapezius muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||kPa||95% Confidence Interval|Least Squares Mean
2577583|NCT02437383|Secondary|Change in Pressure Pain Threshold at Temporomandibular Joint After 9 Weeks of Treatment|Pressure values, measured in kilopascals, from up to 5 experimental pressure stimuli, bilaterally applied to the area of temporomandibular joint, will be averaged to obtain a single pressure pain threshold value per anatomical site.|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||kPa||95% Confidence Interval|Least Squares Mean
2577584|NCT02437383|Secondary|Change in Pressure Pain Threshold at Masseter Muscle After 9 Weeks of Treatment|Pressure values, measured in kilopascals, from up to 5 experimental pressure stimuli, bilaterally applied to the area of masseter muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.|Visit 1 (study day 0) and Visit 4 (study day 63 +/- 7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||kPa||95% Confidence Interval|Least Squares Mean
2577585|NCT02437383|Secondary|Change in Pressure Pain Threshold at Temporalis Muscle After 9 Weeks of Treatment|Pressure values, measured in kilopascals (kPa), from up to 5 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle, are averaged to obtain a single pressure pain threshold value per anatomical site. The range is 0-500 kPa and a higher value means a better outcome.|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||kPa||95% Confidence Interval|Least Squares Mean
2577586|NCT02437383|Secondary|Change in Thermal Pain Tolerance After 9 Weeks of Treatment|Temperature values, measured in degrees Celsius, from 4 examiner-applied contact heat stimuli will be averaged to measure the experimental thermal pain tolerance (temperature at which pain can no longer be tolerated). The range was 32-50 degrees Celsius and a higher value means a better outcome.|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||degrees Celsius||95% Confidence Interval|Least Squares Mean
2577587|NCT02437383|Secondary|Change in Thermal Pain Threshold After 9 Weeks of Treatment|Temperature values, measured in degrees Celsius, from 4 examiner-applied contact heat stimuli will be averaged to measure the experimental thermal pain threshold (temperature at which pain is first perceived). The range was 32-50 degrees Celsius and a higher value means a better outcome.|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||degrees Celsius||95% Confidence Interval|Least Squares Mean
2577588|NCT02437383|Secondary|Change in the SF-12 Health Survey v2 (SF-12v2) Mental Component Summary (MCS) After 9 Weeks of Treatment|"The SF-12v2 contains 7 questions assessing 8 domains of functioning and well-being rated from: excellent to poor (for general health); yes, limited a lot to no, not limited at all (for functional level); and all of the time to none of the time (for emotional state). These 8 domains can be further summarized into a physical component summary (PCS) and a mental component summary (MCS). The range for each component is 0-100 and a higher score means a better outcome."|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||score on a scale||95% Confidence Interval|Least Squares Mean
2577589|NCT02437383|Secondary|Change in the SF-12 Health Survey v2 (SF-12v2) Physical Component Summary (PCS) After 9 Weeks of Treatment|"The SF-12v2 contains 7 questions assessing 8 domains of functioning and well-being rated from: excellent to poor (for general health); yes, limited a lot to no, not limited at all (for functional level); and all of the time to none of the time (for emotional state). These 8 domains can be further summarized into a physical component summary (PCS) and a mental component summary (MCS). summary (MCS). The range for each component is 0-100 and a higher score means a better outcome."|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||score on a scale||95% Confidence Interval|Least Squares Mean
2577590|NCT02437383|Secondary|Change in the Symptom Checklist 90-Revised (SCL-90R) Somatization Scale Score After 9 Weeks of Treatment|"The SCL-90R Somatization Scale is a 12-item assessment of somatic symptom distress over the past 7 days rated from 0 = not at all to 4 = extremely. The scale score is computed as the mean for all items. The score range is from 0 to 4. A higher score means a worse outcome."|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||score on a scale||95% Confidence Interval|Least Squares Mean
2577591|NCT02437383|Secondary|Change in the Hospital Anxiety and Depression Scale (HADS) Anxiety Score After 9 Weeks of Treatment|"The HADS is a 14-item assessment of anxiety (7 items) and depression (7 items) using the relative frequency of symptoms over the past week, rated on a 4-point scale ranging from 0 = not at all to 3 = very often indeed. Responses are summed to provide separate scores for anxiety and depression with a range from 0 to 21. A higher score means a worse outcome."|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||score on a scale||95% Confidence Interval|Least Squares Mean
2577621|NCT02437318|Secondary|Overall Survival (OS) for Patients With PI3KCA Mutant Status|OS is defined as the time from date of randomization to date of death due to any cause.|Up to approximatly 59 months||2021-09-30|09/2021||||
2588893|NCT02299934|Primary|The Relative Signal Intensity of the Liver Blood Supply||Day 1|Study was terminated prior to collecting any outcome measure data.||||||
2577592|NCT02437383|Secondary|Change in the Hospital Anxiety and Depression Scale (HADS) Depression Score After 9 Weeks of Treatment|"The HADS is a 14-item assessment of anxiety (7 items) and depression (7 items) using the relative frequency of symptoms over the past week, rated on a 4-point scale ranging from 0 = not at all to 3 = very often indeed. Responses are summed to provide separate scores for anxiety and depression with a range from 0 to 21. A higher score means a worse outcome."|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||score on a scale||95% Confidence Interval|Least Squares Mean
2577593|NCT02437383|Secondary|Change in the Perceived Stress Scale (PSS) Global Score After 9 Weeks of Treatment|"The PSS assesses the frequency of 14 sources of stress on a scale from 0 = never to 4 = very often. The item scores are summed to yield a global score ranging from 0 to 56. A higher score means a worse outcome."|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||score on a scale||95% Confidence Interval|Least Squares Mean
2577594|NCT02437383|Secondary|Number of Participants Stratified Per Dichotomized Score From the Patient Global Impression of Change (PGIC) Scale After 9 Weeks of Treatment|"The PGIC scale assesses patient overall change in the severity of illness following treatment. Participants rate how they feel now compared with how they felt before receiving study drug on a 7-point scale where 0 = No change or condition has got worse and 6 = A great deal better. A higher score means a better outcome. For analyses, this variable was dichotomized: scores from 0 to 3 were combined in one category of No (no significant improvement) and scores from 4 to 6 were combined in another category of Yes (significant improvement with the study treatment)."|Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||Participants|||Count of Participants
2577595|NCT02437383|Secondary|Change in the Pittsburgh Sleep Quality Index (PSQI) Global Score After 9 Weeks of Treatment|The PSQI has 19 items grouped into 7 component scores, each weighted equally on a 0-3 scale, The 7 component scores are summed to yield a global PSQI score, which has a range of 0-21. A higher score means a worse outcome.|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||score on a scale||95% Confidence Interval|Least Squares Mean
2577596|NCT02437383|Secondary|Change in the Headache Impact Test (HIT-6) Global Score After 9 Weeks of Treatment|"The HIT-6 contains 6 items and assesses headache-related disability by the frequency of daily activity limitations ranging from never to always. The 6 item scores are summed to yield a global score ranging from 36 to 78. A higher score means a worse outcome."|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||score on a scale||95% Confidence Interval|Least Squares Mean
2577597|NCT02437383|Secondary|Change in the Jaw Functional Limitation Scale (JFLS) Global Score After 9 Weeks of Treatment|"The JFLS contains 20 items that measure limitations across mastication, vertical jaw mobility, and verbal/emotional expression rated on a 0-10 scale where 0 = no limitation and 10 = severe limitation. The Global Score is computed as the mean response for all items and ranges from 0 to 10. A higher score means a worse outcome."|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||score on a scale||95% Confidence Interval|Least Squares Mean
2577598|NCT02437383|Secondary|Number of Participants Stratified Per Graded Chronic Pain Scale (GCPS) Grade After 9 Weeks of Treatment|Individuals were classified into 6 chronic pain grades: 0 = no pain; I = low pain intensity and low pain-related disability; IIa = high pain intensity and low pain-related disability; IIb = high pain intensity and high activity interference; III = moderate pain-related disability; and IV = severe pain-related disability. For analyses, this variable was dichotomized: grades 0-IIa were combined in one category and all higher grades in another. A higher grade means a worse outcome.|Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||Participants|||Count of Participants
2577599|NCT02437383|Secondary|Change in the SF-McGill Pain Questionnaire Weekly Fatigue After 9 Weeks of Treatment|"Self-reported average fatigue for the last week scored on 0-100 numerical rating scale where 0 = no fatigue and 100 = the greatest imaginable. A higher score means a worse outcome."|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2577600|NCT02437383|Secondary|Change in the SF-McGill Pain Questionnaire Weekly Average Facial Pain Duration After 9 Weeks of Treatment|"Self-reported average facial pain duration for the last week scored on 0-100 percentage scale where percent = percent of waking day you had facial pain. A higher score means a worse outcome."|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2577601|NCT02437383|Secondary|Change in the SF-McGill Pain Questionnaire Weekly Average Facial Pain Intensity After 9 Weeks of Treatment|"Self-reported average facial pain intensity for the last week scored on 0-100 numerical rating scale where 0 = no pain and 100 = the most intense pain imaginable. A higher score means a worse outcome."|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2577602|NCT02437383|Secondary|Change in the SF-McGill Pain Questionnaire Present Facial Pain Intensity After 9 Weeks of Treatment|"Self-reported present intensity of facial pain at the moment of assessment scored on a descriptive scale where 1 = no pain' and 6 = excruciating pain. A higher score means worse outcome."|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2577674|NCT02436915|Secondary|Percent Change From Baseline to Post Intervention on Geriatric Depression Scale (GDS) Score|GDS total Score. The GDS total score ranges from 0 to 15. Higher GDS score represents more severe depression.|baseline, immediately after intervention and 2 weeks post intervention||||percent change||Standard Deviation|Mean
2577603|NCT02437383|Secondary|Change in the SF-McGill Pain Questionnaire Sensory Component After 9 Weeks of Treatment|"The SF-McGill Pain Questionnaire contains 11 sensory descriptors rated on a 0-3 scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The item scores are summed to yield a total score ranging from 0 to 33. A higher score means a worse outcome."|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||score on a scale||95% Confidence Interval|Least Squares Mean
2577604|NCT02437383|Secondary|Change in the SF-McGill Pain Questionnaire Affective Component After 9 Weeks of Treatment|"The SF-McGill Pain Questionnaire contains 4 affective descriptors rated on a 0-3 scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The item scores are summed to yield a total score ranging from 0 to 12. A higher score means a worse outcome."|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||score on a scale||95% Confidence Interval|Least Squares Mean
2577605|NCT02437383|Secondary|Change in the Weekly Mean Pain Duration After 9 Weeks of Treatment|"Weekly mean pain duration computed as the arithmetic mean of daily pain duration values during the week prior to randomization and prior to each study visit. Daily pain duration is measured on 0-100 percentage scale where percent = percent of waking day you had facial pain as reported in the Daily Symptom Diary. A higher score means a worse outcome."|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)||||units on a scale||95% Confidence Interval|Least Squares Mean
2577606|NCT02437383|Secondary|Change in the Weekly Mean Pain Intensity After 9 Weeks of Treatment|"Weekly mean pain intensity computed as the arithmetic mean of daily pain intensity values during the week prior to randomization and prior to each study visit. Daily pain intensity is measured on 0-100 numeric rating scale where 0 = no pain and 100 = the most intense pain imaginable) as reported in the Daily Symptom Diary. A higher score means a worse outcome."|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2577607|NCT02437383|Primary|Change in the Weekly Mean Pain Index After 9 Weeks of Treatment|"Weekly mean pain index computed as the arithmetic mean of daily pain index values during the week prior to randomization and prior to each study visit. Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = no pain and 100 = the most intense pain imaginable) multiplied by pain duration (0-100 percentage scale where percent = percent of waking day you had facial pain) as reported in the Daily Symptom Diary and divided by 100. The pain index range is from 0 to 100. A higher score means a worse outcome."|Visit 1 (study day 0) and Visit 4 (study day 63 +/-7)|All participants who received at least one dose of study medication and provided at least one post-baseline outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2577608|NCT02437344|Secondary|Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) Scores at Baseline and Administered Subsequently|Subjective Opioid Withdrawal Scale (SOWS) is a scale out of 64 points assessing withdrawal severity that is administered serially, every several hours, over the course of the naltrexone initiation. The questionnaire assesses symptoms that the patient rates on a scale of 0 (not at all) to 4 (extremely). The difference in total (sum) scores between baseline and end-of-induction will be reported. Scores range from 0 to 64.|4 days||||units on a scale||Standard Error|Mean
2577609|NCT02437344|Primary|Successful Naltrexone Initiation|The proportion of participants enrolled in the trial and receiving the infusion to receive XR-NTX|2 weeks||||Participants|||Count of Participants
2577610|NCT02437318|Secondary|OS for Patients With PIK3CA Non-mutant Status|OS is defined as the time from date of randomization to date of death due to any cause.|Up to approximatly 59 months||2021-09-30|09/2021||||
2577611|NCT02437318|Secondary|PFS for Patients With PIK3CA Non-mutant Status|PFS based on local radiology assessments and using RECIST 1.1 criteria in the PIK3CA non-mutant cohort|Up to approximatly 36 months||2021-09-30|09/2021||||
2577612|NCT02437318|Secondary|Summary Statistics of Fulvestrant and Alpelisib Plasma Concentrations|Assessment of any potential impact of fulvestrant on the pharmacokinetics of alpelisib by collection of sparse and trough PK samples.|Day 8 and Day 15 of Cycle 1, then Day 1 of Cycles 2,4, 6, 8||2021-09-30|09/2021||||
2577613|NCT02437318|Secondary|Change in the Global Health Status/(QOL) Scale Score of the EORTC QLQ-C30|Composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment will be summarized|Baseline, Up to approximatly 36 months||2021-09-30|09/2021||||
2577614|NCT02437318|Secondary|Clinical Benefit Rate (CBR)|Clinical benefit rate is defined as the proportion of patients with a best overall response of CR or PR or SD or Non-CR/Non-PD lasting more than 24 weeks based on local investigator assessment.|Up to approximatly 36 months||2021-09-30|09/2021||||
2577615|NCT02437318|Secondary|PFS Based on Radiology Assessments and Using RECIST 1.1 Criteria|PFS in patients with PIK3CA mutant status and patients with PIK3CA non-mutant status as measured in ctDNA.|Baseline, Up to approximatly 36 months||2021-09-30|09/2021||||
2577616|NCT02437318|Secondary|Plasma Concentration-time Profile of Alpelisib Given in Combinatio With Fulvestrant and Appropriate Pharmacokinetics (PK) Parameters|Assessment of any potential impact of fulvestrant on the pharmacokinetics of alpelisib by collection of sparse and trough PK samples. PK parameters includes,but not limited to, Cmin, Cmax, t1/2, AUClast for alpelisib (and any relevant metabolites) and fulvestrant|Day 8 and Day 15 of Cycle 1, then Day 1 of Cycles 2,4, 6, 8||2021-09-30|09/2021||||
2577617|NCT02437318|Secondary|Time to 10% Deterioration in the Global Health Status/Quality of Life (QOL) Scale Score of the EORTC QLQ-C30|Composite measure of change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment will be summarized|Up to approximatly 36 months||2021-09-30|09/2021||||
2577618|NCT02437318|Secondary|Safety and Tolerability of Alpelisib in Combination With Fulvestrant|Safety will be determined by type, frequency and severity of adverse events per CTCAEv4.03 and type, frequency and severity of laboratory toxicities per CTCAEv4.03. Patients will be followed up for the duration of the study.|Up to approximatly 37 months||2021-09-30|09/2021||||
2577619|NCT02437318|Secondary|Time to Definitive Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status|Deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|Baseline, Up to approximatly 36 months||2021-09-30|09/2021||||
2579904|NCT02412501|Secondary|Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 12 Months Post Procedure|TVMI defined as Q Wave or non-Q Wave MI|12 Months||||Participants|||Count of Participants
2577622|NCT02437318|Primary|Progression-free Survival (PFS) Per Investigator Assessment in the PIK3CA Mutant Cohort|PFS, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS will be assessed via a local radiology assessment according to RECIST 1.1|Once approximately 243 PFS events in this cohort had been observed, up to 32 months|The Full analysis set (FAS) comprised of all subjects who were randomized to study treatment (alpelisib plus fulvestrant or matching placebo plus fulvestrant). Analysis comprised all subjects in the FAS with a PIK3CA mutation who were randomized to study treatment.|||Months||95% Confidence Interval|Median
2577623|NCT02437305|Primary|Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention|The subject will complete 3 questionnaires: one pre-intervention, one post-intervention, and one 2 months post-intervention. Several questions will assess the participants knowledge of general melanoma, what it looks like and what are its risk factors. To determine participant retention, the pre-intervention and 2 month post-intervention questionnaires will be evaluated.|2 months post-intervention||||participants|||Number
2577624|NCT02437305|Primary|Number of Participants That Performed Regular Self-Skin Examinations|The subject will complete 3 questionnaires: one pre-intervention, one immediately post-intervention and one 2 months post-intervention. 5 questions will assess whether or not the patient has completed skin-self examinations and knows which areas of the skin to pay attention to. The pre-intervention and 2 month post-intervention questionnaire will be evaluated to determine the number of participants that performed regular self-skin examinations.|2 months post-intervention||||participants|||Number
2577625|NCT02437253|Secondary|Anti-ERT Antibodies|Anti-laronidase antibodies for subjects with MPS I. Anti-idursulfase antibodies for subjects with MPS II.|Day 0 to week 16 of treatment with adalimumab versus placebo|No participants had anti-ERT antibodies|||Participants|||Count of Participants
2577626|NCT02437253|Secondary|Range of Motion - Bilateral Shoulder, Elbow, Hip, Knee|Number of joints with a >5 degree more positive change during 16 weeks of adalimumab versus 16 weeks of placebo. A total of eight joints were measured.|Day 0 to week 16 of treatment with adalimumab versus placebo||||joints|||Number
2577627|NCT02437253|Secondary|Pain Measured by the Visual Analog Scale (VAS) in the Pediatric Pain Questionnaire (PPQ)|"Percent of participants with a >10 mm improvement in either how you feel now or worst pain you had this week on the VA in the PPQ during adalimumab versus during placebo by either parental or subject report. Range is 0-100 mm; lower number means less pain."|Day 0 to week 16 of treatment with adalimumab versus placebo||||Participants|||Count of Participants
2577628|NCT02437253|Secondary|Children's Health Questionnaire - Parent Form 50 Physical Function (PF) Standardized Score|Children's Health Questionnaire - Parent Form 50 physical function (PF) standardized score for participants < 18 years of age. Range is from 0 to 100 (no units) and standardization if determined by comparison to healthy age matched children. Lower values mean decreased physical function. The difference of change in PF standardized score from day 0 to week 16 during adalimumab treatment minus change in PF standardized score from day 0 to week 16 during placebo treatment is reported.|Day 0 to week 16 of treatment with adalimumab versus placebo||||units on a scale||Full Range|Mean
2577629|NCT02437253|Primary|Children's Health Questionnaire - Parent Form 50 Bodily Pain Standardized Score|Children's Health Questionnaire - Parent Form 50 bodily pain (BP) standardized score for participants < 18 years of age. Range is from 0 to 100 (no units) and standardization if determined by comparison to healthy age matched children. Lower values mean increased pain. The difference of change in BP standardized score from day 0 to week 16 during adalimumab treatment minus change in BP standardized score from day 0 to week 16 during placebo treatment is reported.|day 0 to week 16 of treatment with adalimumab versus placebo|This was a cross-over study so within-individual changes are reported.|||units on a scale||Full Range|Mean
2577630|NCT02437188|Primary|Length of Opioid Use (Days)|Participants will record all pain medications (i.e. opioids and non-opioids) taken on a computerized pain medication form (or hardcopy log if participant does not have computer access available) until 3 months after surgery. The computerized pain medication form will list the drug name, route, dose, number taken, and date/time of each dose. When 0 doses of opioids have been recorded for 5 consecutive days, the first date in the series will be used as the point of cessation and the length of time from surgery to this date will be calculated as the length of opioid use.|6 months post surgery|Intent-to-treat - with participants who received surgery|||days||Inter-Quartile Range|Median
2577631|NCT02437188|Primary|Length of Pain (Days)|Participants will record their pain daily after surgery via an electronic (REDCap) or hardcopy log. When pain < 3 has been recorded for 5 consecutive days, the first date in the series will be used as the point of cessation and the length of time from surgery to this date will be calculated as the length of pain.|6 months post surgery|Intent-to-treat - with participants who received surgery|||days||Inter-Quartile Range|Median
2577632|NCT02437188|Primary|Amount of Opioid Use|Participants will be asked total daily dose of opioid medications at 3 months after surgery. All opioid doses converted to oral morphine equivalents.|3 months post surgery|Intent-to-treat - for participants who received surgery|||mg oral morphine||Full Range|Median
2577633|NCT02437188|Primary|Amount of Pain Intensity on 0-10 Numeric Rating Scale|Participants will be asked to rate the intensity of their maximum pain on a vertical, 0-10 numeric rating scale (0-10 NRS) with 0.5 increments at 3 months after surgery. Participants will be asked to provide a number that represents their highest pain intensity during the day if 0 is no pain and 10 is the most intense pain imaginable.|3 months post surgery|Intent-to-treat - with randomized participants who received surgery|||score on a scale||Inter-Quartile Range|Median
2577634|NCT02437188|Primary|Percent of Veterans Willing and Able to Receive the ACT Intervention.|The percent of veterans randomized to the ACT intervention who did receive the ACT intervention will be collected.|Enrollment to 3 months post surgery||||percent|||Number
2577665|NCT02437162|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24|Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. Early escape rule was applied(measurement value at Week 20 and Week 24 was set as missing).|Baseline, Week 4, 8, 12, 16, 20 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2577635|NCT02437162|Secondary|Change From Baseline in Percent Non-work Activity Impairment Due to AS (Assessed by WPAI-SHP) Through Week 24|WPAI-SHP is6-item questionnaire used to assess the degree to which a specified health problem (AS) affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent non-work activity impairment due to AS for each study arm are reported.|Baseline, Week 16 and 24|FAS included participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2577636|NCT02437162|Secondary|Change From Baseline in Percent Overall Work Impairment Due to AS (Assessed by WPAI-SHP) Through Week 24|WPAI-SHP is 6-item questionnaire used to assess the degree to which a specified health problem (AS) affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. Questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent overall work impairment due to AS for each study arm are reported.|Baseline, Week 16 and 24|FAS included participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2577637|NCT02437162|Secondary|Change From Baseline in Percent Impairment While Working Due to AS (Assessed by WPAI-SHP) Through Week 24|"WPAI-SHP is 6-item questionnaire used to assess the degree to which a specified health problem (AS) affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent impairment while working due to AS for each study arm are reported."|Baseline, Week 16 and 24|FAS included participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2577638|NCT02437162|Secondary|Change From Baseline in Percent Work Time Missed Due to AS (Assessed by Work Productivity and Activity Impairment Questionnaire - Specific Health Problem [WPAI-SHP]) Through Week 24|"The WPAI-SHP is a 6-item questionnaire used to assess the degree to which a specified health problem (here AS) affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent work time missed due to AS for each study arm are reported."|Baseline, Week 16 and 24|FAS included participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2577639|NCT02437162|Secondary|Change From Baseline in Berlin Magnetic Resonance Imaging (MRI) Spine Score at Week 24|The study used MRI with fat-saturating techniques such as short tau inversion recovery (STIR) to look for the presence of bone marrow edema. The Berlin modification of Ankylosing Spondylitis spine MRI score for activity (ASspiMRI-a) scoring technique assesses inflammation in each of the 23 disc vertebral units (DVU), capturing edema and erosion. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema [less than or equal to 25% of DVU; 3=severe bone marrow edema (more that 50% of DVU)]. The composite score ranges from 0 to 69, with higher scores indicating more severe inflammation.|Baseline and Week 24|Population included subset of FAS with participants who did not meet early escape criteria and have both baseline and Week 24 MRI assessments.|||Units on a scale||Standard Deviation|Mean
2577672|NCT02436915|Secondary|Percent Change From Baseline to Post Intervention on Dual-task Cost to Standing Sway Area|Postural sway speed - assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during six, 30-second trials of standing with eyes open (single task) or performing a cognitive task (dual task standing) on a stationary force platform (Kistler, Amherst, NY). Dual task cost is defined as the percent change of sway area from single task standing to dual task standing. The outcome was calculated by averaging the dual task costs of the six trials.|baseline, immediately after intervention and 2 weeks post intervention||||percentage change||Standard Deviation|Mean
2577640|NCT02437162|Secondary|Change From Baseline in EQ-5D Index Score at Week 16 and 24|"The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing death. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing)."|Baseline, Week 16 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2577641|NCT02437162|Secondary|Change From Baseline in European Quality of Life 5 Dimension (EQ-5D) Visual Analog Scale (VAS) Score at Week 16 and 24|The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).|Baseline, Week 16 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2577642|NCT02437162|Secondary|Change From Baseline in Patients Global Assessment of Disease Activity Through Week 24|Participants assessed their disease activity using a 10 cm visual analog scale, with responses ranging from 0 (very well) to 10 (very poor). Early escape rule was applied (The measurement value at Week 20 and Week 24 was set as missing).|Baseline, Week 4, 8, 12, 16, 20 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2577643|NCT02437162|Secondary|Change From Baseline in Total Back Pain (TBP) and Night Back Pain (NBP) Through Week 24|The total back pain and nighttime back pain was measured on a VAS (0 to 10 cm; 0 = no pain, 10 = most severe pain). Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).|Baseline, Week 4, 8, 12, 16, 20 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||centimeter||Standard Deviation|Mean
2577644|NCT02437162|Secondary|Change From Baseline in Chest Expansion at Week 16 and 24|Chest expansion is the difference, in centimeter (cm), between the circumference of the chest in maximal inspiration and maximal expiration. It is measured at the level of the fourth intercostal space in males, and just below the breasts in females. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).|Baseline, Week 16 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||centimeter(cm)||Standard Deviation|Mean
2577645|NCT02437162|Secondary|Change From Baseline in BASFI at Week 4, 8, 12, 16 and 20|The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).|Baseline, Week 4, 8, 12, 16 and 20|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2577646|NCT02437162|Secondary|Percentage of Participants Who Achieved ASDAS (CRP) Clinically Important Improvement (Decrease >=1.1) Through Week 24|ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 NRS) included are TBP, duration of DMS, peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*TBP) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058*DMS) + (0.579*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Clinically important improvement in ASDAS is defined as a decrease from baseline >=1.1. ASDAS (CRP) clinical important improvement (decrease >=1.1) is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non- responders).|Baseline, Week 4, 8, 12, 16, 20 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2577673|NCT02436915|Secondary|Percent Change From Baseline to Post Intervention on Trial Making Test (TMT)|Time to complete Trail Making Test part B minus time to complete TMT part A. Slower time to complete TMT-B as compared to TMT-A represents poorer executive function.|baseline, immediately after intervention and 2 weeks post intervention||||percent change||Standard Deviation|Mean
2579905|NCT02412501|Secondary|Number of Participants With Cardiac Death at 12 Months Post Procedure||12 Months||||Participants|||Count of Participants
2577647|NCT02437162|Secondary|Percentage of Participants With ASDAS (CRP) Major Improvement (Decrease >=2.0) Through Week 24|ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*TBP) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058* DMS) + (0.579*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Major improvement in ASDAS is defined as a decrease from baseline >=2.0. ASDAS (CRP) major improvement (decrease >=2.0) is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non- responders).|Baseline, Week 4, 8, 12, 16, 20 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2577648|NCT02437162|Secondary|Percentage of Participants Who Achieved ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20|ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*total back pain) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058* duration of morning stiffness) + (0.579*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Inactive disease is defined as an ASDAS score <1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non- responders).|Week 4, 8, 12, 16, and 20|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2577649|NCT02437162|Secondary|Change From Baseline in Ankylosing Spondylitis Disease Activity Score ASDAS (CRP) Total Score Through Week 24|ASDAS includes CRP mg/L; 4 additional self-reported items (rated 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*TBP)+(0.110*PGA) + (0.073*peripheral pain(PP)/swelling)+(0.058* duration of morning stiffness)+(0.579*Ln(CRP+1)). The disease activity, TBP, and PP/swelling on a NRS(0[normal]-10[very severe]and DMS on NRS(0 to 10, 0 being none and 10 representing a duration=>2 hours). The scores were categorized as: inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity (> 3.5). The calculated score can be from 0 to no defined upper limit. A negative number indicates a reduction in the score which indicates decrease in disease activity. Early escape rule was applied (measurement value was set as missing).|Baseline, Week 4, 8, 12 ,16, 20 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2577650|NCT02437162|Secondary|Percentage of Participants Who Achieved ASAS 5/6 Response at Week 16 and 24|ASAS 5/6 is defined as a >=20% improvement in any 5 of the 6 domains of pain (VAS 0 to 10), patient global (VAS 0 to 10), function (BASFI score), morning stiffness (from BASDAI), hsCRP, and spine mobility (lumbar side flexion). ASAS 5/6 response is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).|Week 16 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2577651|NCT02437162|Secondary|Percentage of Participants Who Achieved Assessment of Spondyloarthritis International Society (ASAS) Partial Remission Through Week 24|Low level of disease activity was measured by criteria for ASAS partial remission, defined as a value below 2 on a scale of 0 to 10 cm in each of the 4 ASAS domains: patient's global assessment of disease activity, total back pain, function (BASFI), inflammation. ASAS partial remission response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).|Baseline, Week 4, 8, 12, 16, 20 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2577652|NCT02437162|Secondary|Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20|ASAS 20 defined as improvement from baseline of greater than or equal to (>=) 20% and with an absolute improvement from baseline of 1 on a 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in the potential remaining domain. ASAS20 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).|Week 4, 8, 12, 16 and 20|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2581337|NCT02393547|Secondary|Waist Circumference|Change in waist circumference from baseline to week 12|12 Weeks|subjects (n=10) who met criteria for prolonged smoking abstinence at week 12|||cm||Standard Deviation|Mean
2577653|NCT02437162|Secondary|Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20|ASAS 40 defined as improvement from baseline of greater than or equal to (>=) 40% and with an absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).|Week 4, 8, 12, 16 and 20|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2577654|NCT02437162|Secondary|Change From Baseline in BASDAI Total Score Through Week 24|The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question relating to morning stiffness duration: 0(0 hours), 10(2 or more hours). In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness will be added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-10) is the average of the overall total score. Higher BASDAI score indicates more severe AS symptom. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).|Baseline, Week 4, 8, 12, 16, 20 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2577655|NCT02437162|Secondary|Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24|BASDAI used to measure the AS disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer cm VAS with 0 being none, and 10 being very severe and for the last question relating to morning stiffness duration: 0(0 hours), 10(2 or more hours). In order to give each of the 5 symptoms equal weight, mean of 2 questions about morning stiffness will be added to total of remaining 4 scores, final BASDAI score (ranging 0-10) is average of overall total score. Higher BASDAI score indicates more severe AS symptom. 20 %,50%, 70%,90% improvement from baseline in BASDAI based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responders).|Baseline, Week 4, 8, 12, 16, 20 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2577656|NCT02437162|Secondary|Percentage of Participants With at Least a 40% Improvement From Baseline in ASAS 40 Components at Week 24|ASAS 40 components included Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe). Percentage of Participants With at least a 40% improvement from baseline in each of the ASAS components was calculated.|Week 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this endpoint.|||Percentage of participants|||Number
2577657|NCT02437162|Secondary|Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS)-Quantity of Sleep/Optimal Sleep at Week 16 and 24|Sleep problems were assessed using the 12-item MOS-SS, a generic instrument designed to assess six dimensions of sleep: Sleep disturbance, Somnolence, Sleep adequacy, Snoring, Awaken short of breath or headache, QS/OS during past W4. 6 dimensions used to generate composite SPI. Increase in score from baseline represents improvement. Sleep adequacy scored 0 (least sleep adequacy[SA]) to 100 (better SA), positive change indicates improvement. QS is scored 0 (less QS) to 24 (greater QS), positive change indicates improvement. Single-item QS asks participants to estimate average number of hours they slept each night during past 4W (0-24 hours) and transformed into dichotomous OS Score, reported 7 (or 8) hours of sleep considered Optimal. OS is scored Yes if average hours of sleep is in range of 7-8 hours. Early escape rule was applied (measurement value was set as missing).|Baseline, Week (W) 16 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||Hours||Standard Deviation|Mean
2577664|NCT02437162|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) Total Score at Week 16 and 24|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Entheses were scored as either 0 (nontender) or 1 (tender) yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness). Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).|Baseline, Week 16 and 24|Population included subset of FAS with enthesitis at baseline. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm.|||Units on a scale||Standard Deviation|Mean
2577658|NCT02437162|Secondary|Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS) at Week 16 and 24|Sleep problems were assessed using the 12-item MOS-SS, a generic instrument designed to assess six dimensions of sleep: Sleep disturbance, Somnolence, Sleep adequacy, Snoring, Awaken short of breath or headache, and Quantity of sleep(QS)/optimal sleep(OS) during the past 4 weeks. The six dimensions were also used to generate the composite Sleep Problems Index (SPI). An increase in score from baseline represents improvement. Sleep disturbance, snoring, somnolence, awaken short of breath, sleep problems index have score ranges from 0(no sleep problems) to 100 (greater sleep problems), negative change indicates improvement. Sleep adequacy scored 0 (least sleep adequacy) to 100 (better sleep adequacy), positive change indicates improvement. Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), positive change indicates improvement. Early escape rule was applied (measurement value was set as missing).|Baseline, Week (W) 16 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2577659|NCT02437162|Secondary|Change From Baseline in BASDAI Inflammation Score Through Week 24|The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration, severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question relating to morning stiffness duration: 0(0 hours), 10(2 or more hours). Change from baseline in inflammation was assessed by calculating the average of the Last 2 Questions of the BASDAI Concerning Morning Stiffness. Early escape rule was applied (measurement value was set as missing).|Baseline, Week 4, 8, 12, 16, 20 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2577660|NCT02437162|Secondary|Change From Baseline in Short Form-(SF)-36 Physical Component Summary (PCS) and SF-36 Mental Component Summary (MCS) at Week 16 and 24|The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score(vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).|Baseline, Week 16 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2577661|NCT02437162|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16 and 24|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). Early escape rule was applied (measurement value was set as missing).|Baseline, Week 16 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2577662|NCT02437162|Secondary|Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) Score at Week 16 and 24|"The ASQoL is a self-administered health-related quality of life (HRQOL) instrument. It consists of 18 items requesting a Yes or No response to questions related to the impact of the disease/condition (including pain) on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. A score of 1 is given to a response of yes on each item and all item scores are summed to a total score with a range of 0 to 18. Higher scores indicate worse HRQOL. Early escape rule was applied (measurement value was set as missing)."|Baseline, Week 16 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2577663|NCT02437162|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16 and 24|The Bath Ankylosing Spondylitis Metrology Index linear function is a combined index of 5 clinical measurements (performed by the Joint Assessor) which reflect axial mobility in the AS patient. The measurements to assess mobility are: 1)Tragus-to-wall; 2)Modified Schober (lumbar flexion); 3)Cervical rotation angle; 4)Lateral spinal flexion; 5)Intermalleolar distance. The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their AS. Early escape rule was applied (measurement value was set as missing).|Baseline, Week 16 and 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2587434|NCT02318940|Secondary|Arterial Puncture|Percentage of participants with Arterial puncture aspiration|intraoperative, an average of 1 hour||||percentage of participants|||Number
2577666|NCT02437162|Secondary|Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score-C Reactive Protein (ASDAS-CRP) Inactive Disease (<1.3) at Week 24|ASDAS includes CRP milligram per liter(mg/L); four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment(PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*TBP) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058* DMS) + (0.579*Ln(CRP+1). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 [normal] to 10 [very severe]) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Inactive disease is defined as an ASDAS score <1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responder).|Week 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2577667|NCT02437162|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Week 24|The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).|Baseline and Week 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this endpoint.|||Units on a scale||Standard Deviation|Mean
2577668|NCT02437162|Secondary|Percentage of Participants Who Achieved at Least a 50 Percent (%) Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24|BASDAI used to measure ankylosing spondylitis (AS) disease severity. Consists of 6 questions: fatigue,spinal pain,arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons, ligaments),morning stiffness(MS) (2 questions:duration, severity). Each question is easy to answer 10cm VAS, 0(none),10(very severe) and for the last question related to morning stiffness duration: 0(0 hours), 10(2 or more hours). In order to give each 5 symptoms equal weight, mean of 2 questions about MS added to total of remaining 4 scores,final BASDAI score(ranging 0-10) is average of overall total score. Higher BASDAI indicates more severe AS symptom. 50% improvement from baseline based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rule(consider non-responder at W20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).|Week 24|Full Analysis Set (FAS) included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2577669|NCT02437162|Secondary|Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 20 Response at Week 24|ASAS 20 defined as improvement from baseline of >= 20% and with an absolute improvement from baseline of 1 on a 0 to 10cm scale in at least 3 of following 4 domains:Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain(0 to 10cm; 0=no pain,10=most severe pain),Bath Ankylosing Spondylitis Functional Index (BASFI) (self-assessment represented as mean(0 to 10 cm; 0=easy to 10=impossible) of 10 questions,8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life, Inflammation (0 to 10cm;0=none,10=very severe);absence of deterioration from baseline(>= 20% and worsening of at least 1 on a 0 to 10 cm scale) in the potential remaining domain. ASAS 20 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).|Week 24|FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2577670|NCT02437162|Primary|Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 24|ASAS 40 defined as improvement from baseline of greater than or equal to (>=) 40 percent (%) and absolute improvement from baseline of at least 2 on 0 to 10 centimeter (cm) scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation(0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).|Week 24|The full analysis set (FAS) included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.|||Percentage of participants|||Number
2577671|NCT02436915|Secondary|Percent Change From Baseline to Post Intervention on Dual Task Cost to Stride Time in 24-meter Walking Test|Six 24-meter walking trials at a preferred speed are completed and each three of them are in normal or dual task condition. The GaitRite pressure mat (Havertown, PA) will be used to record bilateral foot placements and measure the walking speed. Dual task cost to stride time is defined as the percent change of stride time from normal walking to dual task walking.The outcome was calculated by averaging the dual task costs of the six trials.|baseline, immediately after intervention and 2 weeks post intervention||||percent change||Standard Deviation|Mean
2577791|NCT02435511|Other Pre-specified|Access to Resources - Stress Management Classes as Measured by Questionnaire Developed for This Study|Measure perceived and self-reported access to stress management classes|Baseline, 1 week, 1 month and 3 months|||||||
2577675|NCT02436915|Primary|Percent Change From Baseline to Post Intervention on Dual Task Cost to Standing Postural Sway Speed|Postural sway speed - assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during six, 30-second trials of standing with eyes open (single task) or performing a cognitive task (dual task standing) on a stationary force platform (Kistler, Amherst, NY). Dual task cost is defined as the percent change of sway speed from single task standing to dual task standing. The outcome was obtained by averaging the dual task costs of the six trials.|baseline, immediately after intervention and 2 weeks post intervention||||percentage change||Standard Deviation|Mean
2577676|NCT02436915|Primary|Percent Change From Baseline to Post Intervention on Dual Task Cost to Walking Speed in 24-meter Walking Test|Six 24-meter walking trials at a preferred speed are completed and each three of them are in normal or dual task condition. The GaitRite pressure mat (Havertown, PA) will be used to record bilateral foot placements and measure the walking speed. Dual task cost to walking speed is defined as the percent change of walking speed from normal walking to dual task walking. The outcome was calculated by averaging the dual task costs of the six trials.|baseline, immediately after intervention and 2 weeks post intervention||||percent change||Standard Deviation|Mean
2577677|NCT02436915|Primary|Percent Change From Baseline to Post Intervention on Global Cognition Impairment|The Montreal Cognitive Assessment (MoCA) score is used as the outcome measure of Global Cognition Impairment. MoCA score ranges from 0 to 30. Lower MoCA score represents poorer cognitive function (i.e., more severe Global Cognition Impairment).|Baseline, immediately after intervention and 2 weeks post intervention|19 participants were enrolled in the study and completed baseline assessments. One participant withdrew from the follow-up session due to illness deemed unrelated to participation. 18 participants completed all the study sessions.|||percent change||Standard Deviation|Mean
2577678|NCT02436915|Primary|Percent Change From Baseline to Post Intervention on Mobility|"Mobility and turning will be assessed by the timed up-and-go test (TUG) (Podsiadlo & Richardson, 1991). The participant will be seated in an armed chair. On the word go, the subject will stand up using the arm rests if needed, walk (with assistive device if needed) around a cone placed three meters in front of the chair, return and sit down as quickly as possible. Time to complete the TUG test will be used as the outcome measure."|baseline, immediately after intervention and 2 weeks post intervention|19 participants were enrolled in the study and completed baseline assessments. One participant withdrew from the follow-up session due to illness deemed unrelated to participation. 18 participants completed all the study sessions.|||percent change of TUG time||Standard Deviation|Mean
2577679|NCT02436889|Secondary|Change From Baseline in Urge Incontinence Episodes Per Day on a Voiding Diary at 8 Weeks.|The sum of urge type incontinence episodes reported by participants on a voiding diary per day.|Baseline and 8 weeks|Although 21 participants completed week 8 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.|||episodes per day||95% Confidence Interval|Mean
2577680|NCT02436889|Secondary|Change From Baseline in Total Urinary Incontinence Frequency Measured by a Voiding Diary at 8 Weeks|Study participants record number of urinary incontinence episodes in a voiding diary. The total urinary incontinence frequency is the sum of urinary incontinence episodes per day.|Baseline to Week 8|Although 21 participants completed week 8 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.|||episodes per day||95% Confidence Interval|Mean
2577681|NCT02436889|Secondary|Change From Baseline in Short Physical Performance Battery (SPPB) Score at 8 Weeks|Physical function/mobility, Range 0-12, the higher the score the better.|Baseline to Week 8|Although 21 participants completed week 8 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.|||score on a scale||95% Confidence Interval|Mean
2577682|NCT02436889|Secondary|Change From Baseline in Trail Making Test, Trail A Score at 8 Weeks|Trail Making Test, Trail A Time, Range 0-150 seconds, Lower score indicates better functioning|Baseline and 8 weeks|Although 21 participants completed week 8 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.|||seconds||95% Confidence Interval|Mean
2577683|NCT02436889|Secondary|Change From Baseline in California Verbal Learning Test (CVLT) Score at 8 Weeks|Range of 0-80, with the higher the score the better.|Baseline to Week 8|Although 21 participants completed week 8 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.|||Score on a Scale||95% Confidence Interval|Mean
2577684|NCT02436889|Primary|The Number of Participants Who Completed and Discontinued the Study|Feasibility - Assessment of retention rates.|Baseline to Week 8||||Participants|||Count of Participants
2577685|NCT02436811|Primary|Changes in the Knowledge Score|"The knowledge score was assessed by nine statements developed and tested in a pilot study including items related to breastfeeding, supplemental feeding, sugar intake, bottle use, oral hygiene, and use of fluoride toothpaste. These statements were rated on a three-level Likert scale, under the following options: agree, neither agree nor disagree, and disagree, in addition to I don't know. Each correct answer received score 1 whereas incorrect answers such as neither agree nor disagree and I don't know were assigned score 0. The final scores ranged from 0 to 9. Higher values indicate better outcomes."|The nine statements were applied before the intervention (pre-test), after a 15-minute break, the statements were applied again (post-test). After a 4-week interval, the statement were applied once again.||||units on a scale||Standard Deviation|Mean
2577686|NCT02436681|Other Pre-specified|SF36 - Social Functioning|Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Social Functioning which assess aspects of mental health. The higher the score the better the subject's physical health. Range from 0-100.|2 years||||Score||Standard Deviation|Mean
2577687|NCT02436681|Other Pre-specified|SF36 - Physical Functioning|Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Physical Functioning which assess aspects of physical health. The higher the score the better the subject's physical health. Range from 0-100.|2 years|Same as baseline|||Score||Standard Deviation|Mean
2577713|NCT02436330|Secondary|Waist Circumference Change||Change from 6 month waist circumference at 1 year|"One year data was only collected for the participants assigned to the Exergaming and Didactic Health Teaching group. Only 25/35 participants had waist measurements collected at both 6 months and 1 year. Available data was analyzed."|||cm||95% Confidence Interval|Mean
2577688|NCT02436681|Other Pre-specified|SF36 - Mental Component Summary Score|Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Vitality, Role Emotional, Social Functioning, and Mental health which assess aspects of Mental health. These are used to make an overall mental health score, the Mental Component Summary score (MCS). The higher the score the better the subject's mental health. Range from 0-100.|2 years||||Score||Standard Deviation|Mean
2577689|NCT02436681|Other Pre-specified|SF36 - Physical Component Summary Score|Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Physical Function, Role Physical, Bodily Pain, and General health which assess aspects of physical health. These are used to make an overall physical health score, the Physical Component Summary score (PCS). The higher the score the better the subject's physical health. Range from 0-100.|2 years|Lost to follow up 10 Withdrew Consent 2 Death 2|||Score||Standard Deviation|Mean
2577690|NCT02436681|Other Pre-specified|GERD-HRQL Global Assessment|Same as baseline|2 years|Lost to follow up 10 Withdrew Consent 2 Death 2|||Participants|||Count of Participants
2577691|NCT02436681|Other Pre-specified|GERD-HRQL|The Gastroesophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) scale assess on symptoms associated with gastroesophageal reflux disease. There are 10 questions (each representing a GERD symptom such as heartburn) answered on a 6-point scale of 0 - 6 with 0 indicating no symptoms and 5 indicating incapacitating symptoms. The answer to all questions are summed to give you a final score on the scale. Scores may range for 0 (no symptoms) to 50 (incapacitating symptoms).|2 years|Lost to follow up 10 Withdrew Consent 2 Death 2|||Score||Standard Deviation|Mean
2577692|NCT02436681|Other Pre-specified|Radiographic Recurrence|Reports the number of radiographic recurrence of hernia that does not require surgery and are generally asymptomatic. Hernia recurrence was assessed with a barium upper gastrointestinal series or in some cases other imaging analysis to characterize the anatomy of the esophagus.|2 years|Lost to follow up 10 Withdrew Consent 2 Death 2|||Participants|||Count of Participants
2577693|NCT02436681|Primary|Number of Subjects With a Hernia Recurrence Requiring Reoperation|Failure of the index hernia operation which requires another operative procedure to correct. Hernia recurrence was assessed with a barium upper gastrointestinal series or in some cases other imaging analysis to characterize the anatomy of the esophagus.|2 years|Lost to follow up 10 Withdrew Consent 2 Death 2|||Participants|||Count of Participants
2577694|NCT02436577|Secondary|Participants With Clinically Significant Findings in Hematology, Clinical Chemistry and Urinalysis.|Participants were assessed through each laboratory variables for any significant abnormalities. Hematology assessments included white blood cell count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin and others. Clinical chemistry assessment included testing levels of sodium, potassium, urea, creatinine, albumin, calcium, glucose (fasting) and others. Urinalysis assessment included glucose, protein, blood and microscopy (if positive for blood or protein).|At Screening and at Follow-up (these two examinations are 7 to 8 weeks apart).|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.|||participants|||Number
2577695|NCT02436577|Secondary|Participants With Significant Findings in 12-Lead Electrocardiography (ECG).|A 12-lead ECG was obtained after the participant rested in supine position for at least 10 minutes. The study physician was to judge the overall interpretation as normal or abnormal. If abnormal, it was decided as to whether or not the abnormality was clinically significant and the reason for the abnormality was recorded.|At Screening and at Follow-up (these two examinations are 7 to 8 weeks apart).|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.|||participants|||Number
2577696|NCT02436577|Secondary|Mean Change From Baseline for Vital Signs in Supine Pulse Rate.|Vital signs i.e. Pulse (beats per minute [bpm]) were collected after the participant has rested in the supine position for at least 5 minutes.|At Screening and at Follow-up (these two examinations are 7 to 8 weeks apart) and during treatment periods at pre-dose and post-dose at 2, 4 and 24 hours.|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.|||bpm||Standard Deviation|Mean
2577697|NCT02436577|Secondary|Mean Change From Baseline for Vital Signs of Supine Blood Pressure (SBP) and Diastolic BP (DBP)|The following variables were collected after the participants had rested in the supine position for at least 5 minutes: SBP and DBP.|Day 1 (pre dose, 2 hours, and 4 hours post dose) and Day 2 (24 hours post dose).|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.|||mmHg||Standard Deviation|Mean
2577698|NCT02436577|Secondary|Elimination Rate Constant (Kel) of Ticagrelor and Its Active Metabolite AR-C124910XX|Comparison of kel (elimination rate constant) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||1/hour||Standard Deviation|Geometric Mean
2577714|NCT02436330|Secondary|Exergaming Program Component Influence on Attendance|"The experimental group will answer a questionnaire at the end of the 6 month study period, measuring the importance of specific components of the curriculum and motivators which influenced enrollment and compliance with participation. Of interest is measuring the influence of the exergaming curriculum as compared to these other factors. This is a 16-item, 3-point Likert-scale (1 = least important and 3 = most important) questionnaire created specifically for this study. Results were reported based on % of participants rating 3 ,most important, for each curriculum component."|6 months||||percentage of subjects|||Number
2577792|NCT02435511|Other Pre-specified|Access to Resources - Smoking Cessation Classes as Measured by Questionnaire Developed for This Study|Measure perceived and self-reported access to smoking cessation classes|Baseline, 1 week, 1 month and 3 months|||||||
2577699|NCT02436577|Secondary|Number of Participants With Adverse Events (AEs)|An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. The term AE is used generally to include any AE whether serious or non-serious. A serious AE (SAE) is an AE that fulfills one or more of the following criteria: results in death, is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.|From the date of randomization (Day 1 of the first treatment period) until the final follow-up visit (5 to 10 days after last administration of IMP).|The safety analysis set included all participants who received at least 1 dose of ticagrelor and for whom any safety post-dose data were available.|||Participants|||Number
2577700|NCT02436577|Secondary|Ratio of Metabolite AUC to Parent AUC, Adjusted for Differences in Molecular Weights (MRAUC) of Active Metabolite AR-C124910XX|Assessment of MRAUC (Ratio of metabolite AUC to parent AUC, adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2577701|NCT02436577|Secondary|Ratio of Metabolite AUC(0-t) to Parent AUC(0-t), Adjusted for Differences in Molecular Weights (MRAUC [0-t]) of Active Metabolite AR-C124910XX|Assessment of MRAUC(0-t) (Ratio of metabolite AUC(0-t) to parent AUC(0-t), adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2577702|NCT02436577|Secondary|MRCmax (Ratio of Metabolite Cmax to Parent Cmax, Adjusted for Differences in Molecular Weights) of Active Metabolite AR-C124910XX|Assessment of MRCmax (ratio of metabolite Cmax to parent Cmax, adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2577703|NCT02436577|Secondary|Mean Residence Time (MRT) of Ticagrelor and Its Active Metabolite AR-C124910XX|Comparison of MRT (mean residence time) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||hours||Standard Deviation|Geometric Mean
2577704|NCT02436577|Secondary|Terminal Elimination Rate Constant (λz) of Ticagrelor and Its Active Metabolite, AR-C124910XX.|Comparison of terminal elimination rate constant (λz) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||1/hour||Standard Deviation|Mean
2577793|NCT02435511|Other Pre-specified|Access to Resources - Counseling as Measured by Questionnaire Developed for This Study|Measure perceived and self-reported access to counseling|Baseline, 1 week, 1 month and 3 months|||||||
2577794|NCT02435511|Other Pre-specified|Access to Resources - Healthy Eating Classes as Measured by Questionnaire Developed for This Study|Measure perceived and self-reported access to health eating classes|Baseline, 1 week, 1 month and 3 months|||||||
2577705|NCT02436577|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of t½λz (half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||hours||Standard Deviation|Mean
2577706|NCT02436577|Secondary|Time to Reach Maximum Observed Concentration (Tmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of tmax (Time to reach maximum observed concentration) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||hours||Full Range|Median
2577707|NCT02436577|Primary|Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of AUC (Area under plasma concentration-time curve from zero to infinity) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2577708|NCT02436577|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration AUC (0-t) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of AUC(0-t) (Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet - when administered with and without water - and ticagrelor IR tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2577709|NCT02436577|Primary|Maximum Observed Plasma Concentration (Cmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Comparison of Cmax (maximum observed plasma concentration) of ticagrelor and its active metabolite AR-C124910XX following single doses of the orodispersible (OD) tablet - when administered with and without water - and ticagrelor immediate-release (IR) tablet. Blood samples for the determination of plasma concentrations of both ticagrelor and its active metabolite AR-C124910XX will be collected for each treatment period: 0 hours (pre-dose) and post-dose at 0.5 (30 minutes), 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The pharmacokinetic (PK) analysis set consisted of all participants for whom at least 1 of the primary PK parameters, for a given analyte, was calculated for at least 2 treatment periods (where 1 of the treatment periods was the period in which the participant received the reference product [Treatment C]) and who had no major protocol deviations.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2577710|NCT02436330|Secondary|Shuttle Run Change in Number of Shuttle Runs|The shuttle run was completed again by participants in the Experimental group at 1 year. The shuttle run is a standardized field assessment that requires participants to run 20 meters within sequentially shortened time frames of recorded beeps.|Change in number from 6 month shuttle run at 1 year|"One year data was only collected for the participants assigned to the Exergaming and Didactic Health Teaching group. Shuttle run was completed by 20/35 participants in the Experimental group at both 6 months and 1 year. Available data was analyzed."|||number of runs||95% Confidence Interval|Mean
2577711|NCT02436330|Secondary|Heart Rate Change||Change from 6 month Heart rate at 1 year|"One year data was only collected for the participants assigned to the Exergaming and Didactic Health Teaching group. Heart rate data was collected at 6 month and 1 year for 27/35 of the participants. Available data was analyzed."|||beats per minute||95% Confidence Interval|Mean
2577712|NCT02436330|Secondary|Systolic Blood Pressure Change||Change from 6 month Systolic BP at 1 year|"One year data was only collected for the participants assigned to the Exergaming and Didactic Health Teaching group. Systolic blood pressure was only documented at 6 months and 1 year for 27/35 of the participants. Available data is what was analyzed."|||mmHg||95% Confidence Interval|Mean
2588894|NCT02299934|Primary|How Badly the Artifacts Prevented Evaluation by the Reader.||Day 1|Study was terminated prior to collecting any outcome measure data.||||||
2577715|NCT02436330|Secondary|Change in Dietary Intake: Number of Sugar Sweetened Beverages (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total number of sugar sweetened beverages per day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 27/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response regarding sugar sweetened beverage daily intake. Analysis was completed on the available data.|||servings||Standard Deviation|Mean
2577716|NCT02436330|Secondary|Change in Dietary Intake: Number of Fruit Servings (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total number of fruit servings per day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 25/35 from the Experimental group had complete response and 9/13 from the Active comparator group had complete response regarding daily fruit intake. Analysis was completed on the available data.|||Servings||Standard Deviation|Mean
2577717|NCT02436330|Secondary|Change in Dietary Intake: Number of Vegetable Servings (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total number of vegetable servings per day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 25/35 from the Experimental group had complete response and 9/13 from the Active comparator group had complete response regarding daily vegetable intake. Analysis was completed on the available data.|||servings||Standard Deviation|Mean
2577718|NCT02436330|Secondary|Change in Dietary Intake: % Carbohydrates (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total % dietary carbohydrates is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 28/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response regarding %carbohydrates in their daily diet. Analysis was completed on the available data.|||percentage of carbohydrates||Standard Deviation|Mean
2577719|NCT02436330|Secondary|Change in Dietary Intake: % Fat (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total %dietary fat intake per day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 28/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response regarding the %fat in their daily diet. Analysis was completed on the available data.|||percentage of fat||Standard Deviation|Mean
2577720|NCT02436330|Secondary|Dietary Change:Total Calorie Intake (kcal/Day) (Block Alive FFQ)|The Block Alive FFQ: administered at the start and at 6 months to all participants in both groups. FFQ inquires about typical dietary patterns over the previous six months. Total kcal/kg/day is then estimated based upon participant responses.|Change from baseline at 6 months|Missing data: Not all participants completed this survey at both time points. 28/35 from the Experimental group had complete response and 10/13 from the Active comparator group had complete response. Analysis was completed on the available data.|||kcal/day||Standard Deviation|Mean
2577721|NCT02436330|Secondary|Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Global Self-Worth Score|CY-PSPP questionnaire was completed by participants in both groups at baseline and at 6 months. Change in the Global Self-worth scores, which was 1 of 6 sub-domains, is analyzed. This sub-domain contains 6 questions with responses ranging from 1-4 for each question with 1 being the minimum and 4 being the maximum (best) score. The sub-domain score is then calculated as the mean of the 6 responses (minimum to maximum of 1 to 4).The change in score from baseline to 6 months was compared.|Change from baseline to 6 months|Missing Data: The CY-PSPP questionnaire was not completed by all participants at both the baseline visit and the 6 month mark. Therefore this analysis only includes data for participants who completed the questionnaire at both times: 26/35 from the Experimental group and 7/13 from the Active Comparator group.|||scores on a scale||Standard Deviation|Mean
2577722|NCT02436330|Secondary|Self Perception as Assessed Using the Children and Youth Physical Self-Perception Profile (CY-PSPP): Physical Self-Worth Changes in Physical Self-worth|CY-PSPP questionnaire was completed by participants in both groups at baseline and at 6 months. Change in the Physical Self-worth scores, which was 1 of 6 sub-domains, is analyzed. This sub-domain contains 6 questions with responses ranging from 1-4 for each question with 1 being the minimum and 4 being the maximum (best) score. The sub-domain score is then calculated as the mean of the 6 responses (minimum to maximum of 1 to 4).The change in score from baseline to 6 months was compared.|Change from baseline at 6 months|Missing Data: The CY-PSPP questionnaire was not completed by all participants at both the baseline visit and the 6 month mark. Therefore this analysis only includes data for participants who completed the questionnaire at both times: 26/35 from the Experimental group and 7/13 from the Active Comparator group.|||scores on a scale||Standard Deviation|Mean
2577723|NCT02436330|Secondary|Activity Levels Measured by Pedometers (Weekly Steps)|Activity will be measured by pedometers (number of steps) during week 1 and week 24 for both groups. Subjects used the Yamax 200 pedometer to count the steps they took over 1 weeks time.|Change from week 1 to week 24|Missing data: Data was not available from all participants from pedometer use at both the 1 week and 24 week mark, therefore, this analysis only includes 13/35 participant data from the Experimental group and 10/13 participant data collected from the Active comparator group.|||steps||Standard Deviation|Mean
2577760|NCT02435836|Primary|Percentage of Participants With Vital Signs of Potential Clinical Relevance|The vital signs were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.|||percentage of participants|||Number
2577724|NCT02436330|Secondary|Saturday Screen Time as Assessed by Questionnaire|Change in Saturday screen time (reported out as fraction of an hour) will be measured by subject response on questionnaire taken at baseline and at 6 months for both groups. Saturday screen time was defined as the amount of time spent on any screen, on an average Saturday, including: watching television, computer use (laptop, desk top, tablet) or playing video games on the television or other hand held device.|Change in hours from baseline at 6 months|"Missing Data: Survey data regarding Saturday screen time was collected from participants at baseline and again at 6 months. Not all participants completed both surveys, therefore, analysis for this outcome measure only included 28/35 participants from the Experimental group and 8/13 participants from the Active comparator group."|||hours||Standard Deviation|Mean
2577725|NCT02436330|Secondary|After School Screen Time as Reported on Questionnaire|Change in after school screen time (reported out as fraction of 1 hour) will be measured by subject response on questionnaire taken at baseline and at 6 months for both groups. After school screen time was defined as the amount of time spent on any screen, on the average weekday afternoon/evening, including: watching television, computer use (laptop, desk top, tablet) or playing video games on the television or other hand held device.|Change from baseline at 6 months|"Missing Data: Survey data regarding after school screen time was collected from participants at baseline and again at 6 months. Not all participants completed both surveys, therefore, analysis for this outcome measure only included 28/35 participants from the Experimental group and 8/13 participants from the Active comparator group."|||hours||Standard Deviation|Mean
2577726|NCT02436330|Secondary|Shuttle Run Change in Number of Shuttle Runs|The shuttle run was completed by participants at baseline (session 1) and at 6 months. The shuttle run is a standardized field assessment that requires participants to run 20 meters within sequentially shortened time frames of recorded beeps.|Change in number from baseline shuttle run at 6 months|Missing Data: Shuttle run was completed by participants at baseline and at 6 months to document the change in number of runs. Not all participants attended the 6 month measurement visit, therefore, complete data was only available on 24/35 of the Experimental group and 13/13 of the Active comparator group. Available data was analyzed.|||number of runs||Standard Deviation|Mean
2577727|NCT02436330|Secondary|Heart Rate Change From Baseline to 6 Months||Change from baseline at 6 months|Missing Data: Heart rate measurements at baseline and at 6 months was only available for 33/35 Experimental group participants and 12/13 Active comparator group participants. Not all participants attended the 6 month measurement/data collection visit.|||beats per minute||Standard Deviation|Mean
2577728|NCT02436330|Secondary|Systolic Blood Pressure Change||Change from baseline Systolic BP at 6 months|Incomplete data available for analysis. Blood pressure was taken and documented at baseline and at 6 months, however, not all participants were in attendance. Complete data was only available for 33/35 Experimental group participants and 12/13 from the Active comparator group. Available data was analyzed.|||mmHg||Standard Deviation|Mean
2577729|NCT02436330|Secondary|Waist Circumference Change||Change from baseline at 6 months|Incomplete data available for analysis. Change in waist circumference from baseline to 6 month measurements was only collected on 34/35 of the Experimental group and 8/13 of the Active comparator group. The other participants did not show up for the 6 month measurements.|||cm||Standard Deviation|Mean
2577730|NCT02436330|Primary|BMI Z-score Change|Measure was only taken on the subjects who participated in the Intervention group (exergaming combined with didactic teaching).|Change from baseline BMI z-score at 1 year|Complete data was not available for all 35 subjects for this outcome measure. BMI z-score change from baseline to 1 year was only collected on 28 of the 35 participants.|||z-score||95% Confidence Interval|Mean
2577731|NCT02436330|Primary|BMI Z-score Change|All subjects were asked to dress in light athletic clothing and have their weight and height measured at baseline (the first group session) and at 6 months. Research assistants were trained using guidelines from the National Health and Nutrition Examination Survey (NHANES) Anthropometry Procedures Manual and demonstrated accurate measures on 3 separate children. The Seca 217 portable stadiometer was used for all height measurements and the HealthOMeter 844 KL scale was used for all weight measurements. BMI z-scores were calculated using software available from the Children's Hospital of Philadelphia Research Institute (http://stokes.chop.edu/web/zcore).|Change from baseline at 6 months||||z-score||Standard Deviation|Mean
2577732|NCT02436304|Secondary|Time to Cessation of Otorrhea|The time to cessation of otorrhea in the enrolled ear(s) was calculated as the number of days from the day of surgery to the absence of otorrhea (ie, no discharge) as reported by the parent/caregiver. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).|Up to Day 14|ITT analysis set|||days||95% Confidence Interval|Median
2577733|NCT02436304|Secondary|Percentage of Subjects With Microbiological Success at Day 14|Microbiological success was attained if all pretherapy bacteria were absent in the study ear for the test-of-cure (TOC) specimen, which was presumed a success for subjects with no otorrhea at Day 14. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).|Day 14|This analysis population includes all ITT participants who were culture-positive at Day 1 in at least 1 ear (Microbiological Intent-to-Treat (MITT) analysis set)|||percentage of participants|||Number
2577734|NCT02436304|Primary|Percentage of Subjects With Sustained Clinical Cure at Day 8|Sustained clinical cure was defined as the absence of otorrhea in the study ear at Day 8 (end of treatment (EOT)) per the Investigator assessment. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the post-surgical infection. All participants who had missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).|Day 8|ITT analysis set|||percentage of participants|||Number
2577761|NCT02435836|Primary|Number of Participants With Adverse Events (AEs)|The AEs were one of the primary parameters to measure the safety and tolerability of individual participants. The AEs were captured for all participants from the time the ICF was signed until the end of the trial.|Baseline to Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.|||Participants|||Number
2577735|NCT02436239|Secondary|Change From Baseline in Clinical Global Impressions-Improvement (CGI-I)|The Clinical Global Impressions-Improvement is a clinician-rated instrument that was used to rate total improvement or worsening of mental illness, regardless of whether the Investigator considered it to be a result of treatment with the investigational product. The CGI-I was used to rate the patient's improvement on a scale from 1 to 7, with 1 indicating that the patient was very much improved (with a score of 4 indicating no change) and 7 indicating the patient was very much worse.|Baseline (Week 0) to Week 26|The CGI-I was assessed in the Intent to Treat study population, comprised of the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.|||units on a scale||Standard Deviation|Mean
2577736|NCT02436239|Secondary|Change From Baseline in the CGI-S Score|The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients.|Baseline (Week 0) to Week 26|The CGI-S was assessed in the Intent to Treat study population, comprised of the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.|||units on a scale||Standard Deviation|Mean
2577737|NCT02436239|Secondary|Change From Baseline in the CDRS-R Total Score|The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.|Baseline (Week 0) to Week 26|The Change From Baseline in the CDRS-R Total Score was assessed in the Intent to Treat study population, comprised of the 325 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of the CDRS-R total score.|||units on a scale||Standard Deviation|Mean
2577738|NCT02436239|Primary|Number of Participants to Experience a Treatment Emergent Adverse Event (TEAE)|The number of Participants who experienced a treatment emergent adverse events during the 27 week period from screening to the end of the open-label treatment period|Visit 1 (Week -1) to up to Visit 16 (Week 26)|The Safety Population consisted of the 330 participants who took at least 1 dose of open-label investigational product.|||Participants|||Count of Participants
2577739|NCT02436200|Secondary|Serum Metabolic Profile|A serum sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out.|Change of profile at baseline and 6 weeks|||||||
2577740|NCT02436200|Secondary|Urine Metabolic Profile|A urine sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out.|Change of profile at baseline and at 6 weeks|||||||
2577741|NCT02436200|Secondary|Quality of Life Scores Measured by Questionnaire|Validated questionnaires including the Euro-Quol 5D and Short Form 36 will be measured at baseline and 6 weeks.|Change in baseline quality of life at 6 weeks|||||||
2577742|NCT02436200|Secondary|Symptomatic Scores by Questionnaire|Validated questionnaires including the Edinburgh Claudication Questionnaire and Intermittent Claudication Questionnaire will be obtained at baseline and week 6.|Change in baseline questionnaire scores at 6 weeks|||||||
2577743|NCT02436200|Secondary|Laser Doppler Flow Measured by Optical Laser|Optical laser flowmetry probes will be used to assess the superficial skin circulation and temperature.|Change in baseline flowmetry at 6 weeks|||||||
2577744|NCT02436200|Secondary|Femoral Haemodynamics Measured by Femoral Artery Duplex Ultrasonography|Ultrasound assessment of blood flow dynamics in the femoral artery will be obtained at rest, and if randomised to the intervention group, whilst using the device.|Change in baseline femoral haemodynamics at 6 weeks|||||||
2577745|NCT02436200|Primary|Absolute Walking Distance Measured by Treadmill|For the absolute claudication distance measurement, a fixed load treadmill test will be carried out at 3.5 km/h with a 10% gradient. The absolute claudication distance (ACD) is the distance walked before the participant is forced to stop due to typical pain.|Change in baseline treadmill walking distance at 6 weeks||||m||Inter-Quartile Range|Median
2577746|NCT02436200|Primary|Initial Walking Distance Measured by Treadmill|For the initial claudication distance measurement, a fixed load treadmill test will be carried out at 3.5 km/h with a 10% gradient. The initial claudication distance (ICD) is the distance walked until the onset of pain.|Change in baseline treadmill walking distance at 6 weeks||||metres||Inter-Quartile Range|Median
2577747|NCT02436031|Secondary|Number of Apnoea-Hypopnea Index (AHI) Events During Non-Random Eye Movement (NREM) Sleep|The AHI is the number of apneas (pauses in breathing) or hypopneas (shallow breathing) recorded during the study per hour of sleep. Data for the calculation of the AHI was collected while the participant was in NREM sleep in the supine position and off CPAP (breathing spontaneously).|1 night|All participants who were randomized, completed both study nights, and were included in the analysis. 1 participant was excluded due to insufficient sleep time.|||events per hour||Inter-Quartile Range|Median
2577748|NCT02436031|Secondary|Genioglossus Muscle Responsiveness to Progressively Greater Epiglottic Pressure Swings|Electromyography (EMG) was used to analyze genioglossus (GG) [EMG GG] muscle activity. EMG GG activity was recorded via standard needle electrodes inserted into the genioglossus muscle (tongue). Activity of EMG GG was measured during wakefulness and sleep as % of maximum activation obtained pushing the tongue against closed teeth during wakefulness (GG%max). Participants were connected to a modified continuous positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which provided a wide range of pressures between 20 and -20 cm H2O in order to modify upper airway pressure and measure change in EMG GG as a function of epiglottic pressure (muscle responsiveness) (%max/cmH2O).|1 night|All participants who were randomized, completed both study nights, and were included in the analysis. 1 participant was excluded due to insufficient sleep time.|||%max/cmH2O||Inter-Quartile Range|Median
2577785|NCT02435524|Primary|Exclusive Breastfeeding on the Day Preceding the Interview as Assessed by Cross Sectional Survey|The percentage of infants aged less than 6 months who were exclusively breastfed on the day preceding the interview.|Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017|Endline survey participants with infant aged less than 6 months|||percentage of exclusive breastfeeding||95% Confidence Interval|Number
2577749|NCT02436031|Primary|Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility|Participants were connected to a modified continuous positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which provided a wide range of pressures between 20 and -20 cm H2O in order to modify upper airway pressure. Following a baseline recording period of 5 minutes, the CPAP level was reduced to varying suboptimal pressures. Change in Pcrit was used to determine the collapsibility of the upper airway under both passive and active conditions, and is expressed as Passive Pcrit: ventilation at a nasal pressure of 0 cm H2O when pharyngeal muscles are passive; Active Pcrit: ventilation at a nasal pressure of 0 cm H2O when pharyngeal muscles are active. Improved=more negative Pcrit.|1 night|All participants who were randomized, completed both study nights, and were included in the analysis. 1 participant was excluded due to insufficient sleep time.|||cm H2O||Inter-Quartile Range|Median
2577750|NCT02435966|Secondary|Change in the Neck Disability Index Questionnaire||Pre-intervention (Day 1); after 2nd intervention (7 days)|||||||
2577751|NCT02435966|Secondary|Change in the Cervical Range of Motion Measured by Goniometer|Measured by goniometer, with the standard measurement procedure|Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)|||||||
2577752|NCT02435966|Secondary|Change in the Pressure Pain Threshold Measured by Algometer|Measured by algometer, with the standard measurement procedure|Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)|||||||
2577753|NCT02435966|Primary|Change in Pain Scores on the Visual Analog Scale (VAS: 0-10) After 30 Days|The Visual Analogue Scale is a validated, self-reported instrument to assess pain, with scores ranging from 0 (no pain) to 10 (maximum pain). We assess the change in chronic neck pain after 30 days, after to interventions in days 1 and 7) as compared to the baseline VAS|Pre-intervention (Day 1); After 1st intervention (Day 1); after 2nd intervention (7 days later); after followup (30 days later)||||units on a scale||Standard Deviation|Mean
2577754|NCT02435914|Secondary|Percentage of Participants With Complete Redness Response (Yes/No) in the Study Eye|A participant was considered a redness responder if the study quadrant redness score based on the Allergan Dry Eye Redness Scale in the study eye was 0=Normal (no redness).|Day 14|Participants from the mITT population, all randomized and treated participants who had a baseline and at least 1 post-baseline assessment of nasal or temporal redness using the Allergan Dry Eye Redness Scale. with data available for analysis.|||percentage of participants|||Number
2577755|NCT02435914|Secondary|Change From Baseline in Corneal Staining Score of the Study Eye Using a 6-Point Scale|The cornea is the transparent front part of the eye which covers the iris and pupil. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale where: 0=no staining to 5=diffuse staining. The higher the grade score, the worse the dry eye severity. A negative change from Baseline indicates improvement.|Baseline, Day 14|"mITT population, consisted of all randomized and treated participants who had a baseline and at least 1 post-baseline assessment of nasal or temporal redness using the Allergan Dry Eye Redness Scale. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2577756|NCT02435914|Secondary|Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score Using a 5-Point Scale|OSDI questionnaire consists of 12 questions regarding ocular symptoms, environmental triggers, and vision-related functioning in patients with dry eye disease. The participants rate each question on a 5-point scale where: 0=none of the time to 4=all of the time. The scores are totaled over the 12 questions and normalized/converted to a total score of 0=no disability to 100=complete disability. Higher OSDI scores are associated with greater severity. A negative change from Baseline indicates improvement.|Baseline, Day 14|"mITT population, consisted of all randomized and treated participants who had a baseline and at least 1 post-baseline assessment of nasal or temporal redness using the Allergan Dry Eye Redness Scale. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2577757|NCT02435914|Primary|Change From Baseline in Conjunctival Redness Score in the Study Eye Using a 5-Point Scale|Nasal and temporal bulbar conjunctival hyperemia were graded separately in each eye by the investigator under slit-lamp magnification by assigning a score of 0 to 4 for each quadrant based on comparison to the Allergan Dry Eye Redness Scale with photographic reference where: 0=Normal, vessels of bulbar conjunctiva are easily observed; 1=Trace redness; 2=Mild redness; 3=Moderate redness; 4=Severe redness, and each score is associated with a reference photo. For each eye, the study quadrant was determined by the greater (more severe) of the baseline redness scores for nasal and temporal bulbar conjunctival hyperemia as assessed using the Allergan Dry Eye Redness Scale. If the temporal score was greater than the nasal score, then the temporal quadrant was the study quadrant for the eye and was used to assess primary efficacy; otherwise the nasal quadrant was the study quadrant. A negative change from baseline (less redness) indicates improvement.|Baseline, Day 14|"Modified Intent-to-treat (mITT) population, consisted of all randomized and treated patients who had a baseline and at least 1 post-baseline assessment of nasal or temporal redness using the Allergan Dry Eye Redness Scale. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2577758|NCT02435836|Primary|Percentage of Participants With Laboratory Values of Potential Clinical Relevance|The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.|||Percentage of participants|||Number
2577759|NCT02435836|Primary|Percentage of Participants With ECG Measurements of Potential Clinical Relevance|The measurement of ECG was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, and QTcF that were identified based on pre-defined criteria.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.|||Percentage of participants|||Number
2593114|NCT02249104|Secondary|Percent Change From Baseline in Non-inflammatory Lesion Count||Baseline and 8 weeks||||Percent change||Standard Deviation|Mean
2577762|NCT02435836|Primary|Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week|The AIMS assessment consisted of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest (e.g., in the waiting room), and the study physician would make global judgments on the participant's dyskinesia's (items 8 through 10). For this scale, the participant was seated on a hard, firm chair. These items are rated on a five-point scale: 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). The total score ranges from 0 to 40. Negative changes from baseline indicate an improvement, with higher negative values indicating better improvement.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.|||Units on a scale||Standard Deviation|Mean
2577763|NCT02435836|Primary|Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week|BARS consisted of 4 items: objective observation of akathisia by study physician, subjective feelings of restlessness by participant, participant distress due to akathisia, global evaluation of akathisia. The first 3 items were rated on a 4-point scale: 0 = absence of symptoms to 3 = severe condition. The global clinical evaluation were made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe). Participants were observed while they were seated and then stood for a minimum of 2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral conversation or engaged in activity on the ward) may also be rated. Subjective phenomena were elicited by direct questioning. The BARS Global Score was derived from the global clinical assessment of akathisia from the BARS panel. Total score ranges from 0 to 14. Negative changes from baseline indicate improvement, with higher negative values indicating better improvement.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.|||Units on a scale||Standard Deviation|Mean
2577764|NCT02435836|Primary|Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week|The SAS is composed of 10 items. This scale contains 10 items: Gait, Arm dropping, Shoulder shaking, Elbow rigidity, Wrist rigidity, Head rotation, Glabella Tap, Tremor, Salivation, Akathisia. Grade of severity of each item is rated using a 5-point scale, 1 (normal) and 5 (most severe). The total score ranges from 10 to 50. Negative changes from baseline indicate an improvement, with higher negative values indicating better improvement.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.|||Units on a scale||Standard Deviation|Mean
2577765|NCT02435836|Primary|Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. The questionnaire includes questions on the following symptoms. 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The usual cut-off points are: 0 to 6 = normal/ symptom absent, 7 to 19 = mild depression, 20 to 34 = moderate depression, >34 = severe depression.|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.|||Units on a scale||Standard Deviation|Mean
2577766|NCT02435836|Primary|Mean Clinical Global Impression of Improvement (CGI-I) by Week|"The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5~=minimally worse; 6 = much worse; and 7 = very much worse."|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.|||Units on a scale||Standard Deviation|Mean
2577767|NCT02435836|Primary|Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.|||Units on a scale||Standard Deviation|Mean
2577768|NCT02435836|Primary|Mean Change From Baseline in PANSS Negative Sub-scale Score by Week|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.|||Units on a scale||Standard Deviation|Mean
2577786|NCT02435511|Other Pre-specified|Self-efficacy - Exercise as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale|Measure confidence in ability to exercise|Baseline, 1 week, 1 month and 3 months|||||||
2577787|NCT02435511|Other Pre-specified|Self-efficacy - Eating Healthy as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale|Measure confidence in ability to eat healthy|Baseline, 1 week, 1 month and 3 months|||||||
2577769|NCT02435836|Primary|Mean Change From Baseline in PANSS Positive Sub-scale Score by Week|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.|||Units on a scale||Standard Deviation|Mean
2577770|NCT02435836|Primary|Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit|All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.|||Units on a scale||Standard Deviation|Mean
2577771|NCT02435706|Secondary|Change in Interproximal Crestal Bone Levels||Change from Baseline in Interproximal Crestal Bone Levels at 6 and 12 months||||mm||Standard Deviation|Mean
2577772|NCT02435706|Secondary|Change in Buccal Horizontal Ridge Dimensions|Horizontal changes of the buccal ridge was calculated through the use of acrylic stents and digital overlays (3Shape D800, Biomet 3i, Palm Beach Gardens, FLS). The acrylic stents were obtained from the pre-surgical plaster casts and they were repositioned on the plaster casts obtained at 3, 6 and 12 months. Discrepancies between the acrylic stent and the plaster cast were measured with a probe. The digital cast overlays were used to analyze changes from pre-surgical to 3 and from 3 to 6 months). The plaster casts were scanned and changes were analyzed with the use of a software.|Change from Baseline in Buccal Horizontal Ridge Dimensions at 3, 6 and 12 months||||mm||Standard Deviation|Mean
2577773|NCT02435706|Primary|Change in Gingival Margin Location on the Buccal, Mesial and Distal Compared With Pre-operative Baseline and Post-operative Baseline||Change from Pre-operative Baseline in Gingival Margin Location at 3, 6 and 12 months and change from post-operative baseline at 3 and 6 months||||mm||Standard Deviation|Mean
2577774|NCT02435524|Secondary|Knowledge, Beliefs and Perceptions Surrounding Breastfeeding of Family Members|Knowledge, beliefs and perceptions of family members, such as mothers or mothers in law, community opinion leaders towards optimal infant and child feeding practices (qualitative component).|Family members of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017|||||||
2577775|NCT02435524|Secondary|Mother's Perceptions and Beliefs Surrounding Breastfeeding|Mother's perceptions and beliefs about breastfeeding (qualitative component).|Mothers of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017|||||||
2577776|NCT02435524|Secondary|Mother's Self-reported Breastfeeding Practices as Assessed by Cross Sectional Survey|Mother's self-reported breastfeeding practices, including asking her if she experiences any barriers or difficulties with breastfeeding such as engorgement, cracked and sore nipples, or breastfeeding when working outside of the home.|Mothers of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017|||||||
2577777|NCT02435524|Secondary|Mother's Accurate Knowledge of Good Breastfeeding Practice as Assessed by Cross Sectional Survey|"Mother's accurate knowledge of:~Optimal timing of breastfeeding initiation~Optimal duration of exclusive breastfeeding~Benefits of optimal breastfeeding practices for the infant~Solutions to common difficulties, for example engorgement, cracked and sore nipples~Optimal timing to introduce complementary feeding~Optimal dietary diversity and frequency of complementary feeding up to 12 months"|Mothers of infants aged up to 12 months in a cross-sectional endline survey scheduled for April - July 2017|||||||
2577778|NCT02435524|Secondary|Breast Milk on the Day Preceding the Interview as Assessed by Cross Sectional Survey|The proportion of children aged 6 to 11.9 months who were fed breast milk on the day preceding the interview.|Infants age 6-11.9 months in a cross-sectional endline survey scheduled for April - July 2017|||||||
2577779|NCT02435524|Secondary|Dietary Diversity as Assessed by Cross Sectional Survey|Dietary diversity among infants age 6 to 11.9 months.|Infants age 6-11.9 months in a cross-sectional endline survey scheduled for April - July 2017|||||||
2577780|NCT02435524|Secondary|Minimum Acceptable Diet (Apart From Breast Milk) on the Day Preceding Interview as Assessed by Cross Sectional Survey|The proportion of infants aged 6 to 11.9 months who received a minimum acceptable diet (apart from breast milk) on the day preceding interview.|Infants age 6-11.9 months in a cross-sectional endline survey scheduled for April - July 2017|||||||
2577781|NCT02435524|Secondary|Semi-solid, Solid or Soft Foods Consumed in the Previous Day as Assessed by Cross Sectional Survey|The proportion of infants age 6 to 8 months who received semi-solid, solid or soft foods in the previous day.|Infants age 6-8 months in a cross-sectional endline survey scheduled for April - July 2017|||||||
2577782|NCT02435524|Secondary|Pre-lacteal Feeds as Assessed by Cross Sectional Survey|The proportion of newborns aged less than 6 months who received no pre-lacteal feeds before breastfeeding was established|Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017|||||||
2577783|NCT02435524|Secondary|Colostrum Given as Assessed by Cross Sectional Survey|The proportion of newborns aged less than 6 months who were given colostrum.|Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017|||||||
2577784|NCT02435524|Secondary|Breastfeeding Within 1 Hour of Birth as Assessed by Cross Sectional Survey|The proportion of newborns aged less than 6 months who were breastfed within 1 hour of birth.|Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017|||||||
2577788|NCT02435511|Other Pre-specified|Self-efficacy - Weight as Measured by Questionnaire Based on Healthy People 20/20 and Applies Likert Scale|Measure confidence in ability to manage weight|Baseline, 1 week, 1 month and 3 months|||||||
2577795|NCT02435511|Other Pre-specified|Access to Resources - Weight Loss Class or Support Group as Measured by Questionnaire Developed for This Study|Measure perceived and self-reported access to weight loss classes or support groups|Baseline, 1 week, 1 month and 3 months|||||||
2577796|NCT02435511|Secondary|Self-efficacy - Finding Places and Services in Community to Manage Health as Measured by Questionnaire|Measure confidence in ability to find services to take care of health|Assessed at baseline, 1 week, 1 month and 3 months; score at 3 months reported|The below results include only those with 3 month follow-up data; 1 control and 3 cases did not complete this survey item during the 3 month follow up.|||Participants|||Count of Participants
2577797|NCT02435511|Secondary|Physical Health-related Quality of Life at 3 Months|Health-related quality of life will be measured using the Short Form-12 (SF-12). Minimum value=0, maximum value=100. Higher scores equal better physical health.|Assessed at baseline, 1 week, 1 month and 3 months; 3 months reported|The below mean includes only participants with completed 3 month follow-up surveys; 1 control and 2 cases did not complete the SF-12 items needed to calculate this measure.|||score on a scale||Standard Deviation|Mean
2577798|NCT02435511|Secondary|Patient Satisfaction at 3 Months|Patient satisfaction will be measures using the domain of general satisfaction from the Patient Satisfaction Questionnaire (PSQ-18)|Assessed at baseline, 1 week, 1 month and 3 months; 3 months reported here|Includes participates who completed 3 month survey; 1 control and 3 cases did not complete the PSQ.|||units on a scale||Standard Deviation|Mean
2577799|NCT02435511|Secondary|Change From Baseline in Cost Effectiveness at 3 Months|Using claims data and self-reported data on heath care utilization, we will use data from intervention baseline and at 3 months following the intervention to assess the cost effectiveness of HealtheRx.|Baseline, 3 months|We were unable to obtain the claims data necessary to conduct the cost effectiveness analysis.||||||
2577800|NCT02435511|Primary|Mental Health-related Quality of Life at 3 Months|Health-related quality of life will be measured using the Short Form Health Survey (SF-12) . Minimum value=0, maximum value=100. Higher scores equal better mental health.|Assessed at Baseline, 1 Week, 1 Month and 3 Months; score at 3 months reported|The below mean includes only those who completed the 3 month follow-up survey; 1 control and 2 cases participated in the 3 months survey but did not complete the SF-12 needed for this data point|||score on a scale||Standard Deviation|Mean
2577801|NCT02435433|Secondary|Time to Deterioration in Eastern Cooperative Oncology Group Performance Status (ECOG PS)|Time to deterioration in ECOG PS is defined as the time from the date of randomization to the first date observing ECOG PS 2 (ie, deterioration from baseline status of 0 [fully active] or 1 [restricted in physically strenuous activity but ambulatory and able to carry out light work]). Participants without PS deterioration were censored at their last documented assessments of 0 or 1. Assessments included ECOG Performance Status (PS): 2- Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours, 3 -Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4 -Completely disabled, cannot carry on any self-care. Totally confined to bed or chair, 5- Dead.|From Randomization through First Date of Deterioration Observation (ECOG PS≥2) (Up to 28 Months)|All randomized participants and had evaluable ECOG data. Censored participants without any post baseline assessments at randomization date were in the Ramucirumab + BSC arm = 141 and the Placebo + BSC arm =75. All randomized participants (including the censored participants) were included in the analyses.|||Months||95% Confidence Interval|Median
2577802|NCT02435433|Secondary|Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire|The EQ-5D-5L is a nonspecific and standardized instrument for use as a measure of self-reported health status (EuroQol Group 1990; Herdman et al. 2011). Participants completed the 5-level (no problems, slight problems, moderate problems, severe problems, and extreme problems), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. A unique EQ-5D-5L health state scale ranges from 0 to 100 and is defined by combining 1 level from each of the 5 dimensions. Participants indicated their current health status by marking on a continuum ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).|From Randomization through End of Study (Up to 28 Months)|All randomized participants and had evaluable EQ-5D-5L data.|||units on a scale||Standard Deviation|Mean
2577803|NCT02435433|Secondary|Time to Deterioration of Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)|"The FACT Hepatobiliary Symptom Index (FHSI-8) is a instrument with specific focus regarding the most frequent and concerning symptoms experienced by participants with hepatobiliary malignancies, including lack of energy, nausea, pain, weight loss, pain in back, fatigue, jaundice, stomach pain or discomfort. The (FHSI-8) questionnaire was used to assess the time to deterioration of FSHI-8 total score issued from the date of randomization to the first date observing deterioration, with the deterioration threshold defined as a decrease ≥ 3-points from baseline. In case of no deterioration, the participants were censored at the time of the last FSHI-8 item recording. FHSI-8 total score ranges from 0 to 32 where 0 is a severely symptomatic participant and the highest score indicates an asymptomatic participant. Kaplan-Meier method Hazard ratio was used to estimate (Ramucirumab versus Placebo) and 95% Confidence Interval (CI) (Wald) were estimated from un-stratified/stratified Cox model."|From Randomization to the First Date of Deterioration Observation (≥ 3-point decrease) (Up to 28 Months)|All randomized participants who had evaluable FHSI-8 data.|||Months||95% Confidence Interval|Median
2577804|NCT02435433|Secondary|Percentage of Participants With Anti-Ramucirumab Antibodies|Percentage of participants with positive treatment emergent anti-drug antibodies was summarized by treatment group. A treatment-emergent ADA (TEADA) was defined as: having a negative ADA at baseline and an ADA titer greater than or equal to 1:20 (that is (i.e.), greater than 2-fold from the minimal required dilution of 1:10) any time post baseline (i.e., treatment-induced); or a 4-fold or greater change in ADA titer from baseline for participants that had a detectable ADA titer at baseline (i.e., treatment boosted).|Predose Cycle 1: 7 Days prior to First Infusion, Cycle 4: 3 Days Prior to Infusion, Cycle 7 through Follow Up (Up to 28 Months)|All randomized participants who received at least one dose of study drug and had evaluable anti-ramucirumab data.|||percentage of participants|||Number
2577867|NCT02434497|Secondary|Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline TC|participants|95% Confidence Interval|Geometric Mean
2593115|NCT02249104|Secondary|Percent Change From Baseline in Inflammatory Lesion Count||Baseline and 8 weeks||||Percent change||Standard Deviation|Mean
2577805|NCT02435433|Secondary|PK: Serum Concentration Maximum (Cmax) After 1st, 2nd, 4th, 7th and 10th Ram Infusion|PK Cmax of Ramucirumab Blood samples were collected at specified time points, and in the event of an infusion-related reaction, for assessment of ramucirumab serum concentrations.|Weeks 0, 2, 6, 12 and 18, Day 1; 1 hour to 1.5 hours Post End of Infusion (14 day-Cycles)|All randomized participants who had received at least one dose of study drug.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2577806|NCT02435433|Secondary|Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) Before 2nd, 4th, 7th, and 10th Infusion|PK Cmin of Ramucirumab Blood samples were collected at specified time points, and in the event of an infusion-related reaction, for assessment of ramucirumab serum concentrations.|Predose, Weeks 2, 6, 12 and 18, Day 1; Up to 3 Days Before Infusion (14-Day Cycles)|All randomized participants who received at least one dose of study drug.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2577807|NCT02435433|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)|Objective response rate is defined as the percentage of participants who achieve a best overall response of complete response (CR) + partial response (PR). ORR = CR + PR. CR is the disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. Best overall response is classified based on the overall responses assessed by study investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.|From Randomization to Objective Progression (Up to 28 Months)|All randomized participants.|||percentage of participants|||Number
2577808|NCT02435433|Secondary|Time to Radiographic Progression|Time to radiographic progression is defined as the time from the date of randomization to the date of first observation of objective progression. Progressive disease (PD) is referenced as the smallest measurements recorded since the treatment started.|From Randomization to Objective Progression (Up to 28 Months)|All randomized participants.|||Months||95% Confidence Interval|Median
2577809|NCT02435433|Secondary|Progression Free Survival (PFS)|Progression-free survival is defined as time from the date of randomization to the date of first observation of objective progression or death from any cause. Progressive disease (PD) is referenced as the smallest measurements recorded since the treatment started.|From Randomization to Objective Progression or Death from Any Cause (Up to 28 Months)|All randomized participants. Participants were censored in the Ramucirumab arm = 25 and in the Placebo arm = 9. All randomized participants (including the censored participants) were included in the analyses.|||Months||95% Confidence Interval|Median
2577810|NCT02435433|Primary|Overall Survival (OS)|OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive.|From Date of Randomization to Death from Any Cause (Up to 28 Months)|All randomized participants. Participants were censored in Ramucirumab arm = 50 and Placebo arm = 21. All randomized participants (including the censored participants) were included in the analyses.|||Months||95% Confidence Interval|Median
2577811|NCT02435277|Secondary|Change in Fasting Plasma Glucose|Change in fasting plasma glucose from Baseline (Day 1/Visit 1) of Study NS-0100-01 to Week 12 (Day 84/Visit 3E). Based on the pre-specified mixed model inferential statistical analysis, there was an apparent dose-dependent relationship for the mean decrease from baseline in fasting plasma glucose for the fixed dose leucine amd metformin combination treatments A, B and C.|Baseline and 12 weeks|Mixed Model Inferential Statistical Analysis of Fasting Plasma Glucose change from day 1-day 84 in Evaluable Population (n=43)|||mg/dL||Standard Deviation|Mean
2577812|NCT02435277|Primary|Change in HbA1c Levels in Patient Receiving the Various Doses of Leucine and Metformin Combinations|Change in HbA1c from Baseline (Day 1/Visit 1) of Study NS-0100-01 to Week 12 (Day 84/Visit 3E) in subjects receiving various fixed-dose combinations of leucine and metformin compared to standard metformin monotherapy.|Baseline and 12 weeks|Mixed Model Inferential Statistical Analysis of HbA1c change from day 1-day 84 Evaluable Population (n=43)|||percent HbA1c||Standard Deviation|Mean
2577813|NCT02435147|Secondary|Proportion of Change in Mean Femur Strength Index Score|Proportion of change in mean Femur Strength Index Score at 36 months following denosumab initiation|Baseline and 36 months||||Proportion of change||Standard Deviation|Mean
2577814|NCT02435147|Primary|Proportion of Change in Mean Trabecular Bone Score|Proportion of change in mean trabecular bone score at 36 months following denosumab initiation|Baseline and 36 months||||Proportion of change||Standard Deviation|Mean
2577815|NCT02435069|Secondary|Number of Participants Experiencing Vagal Symptoms With Flush|Vagal symptoms including nausea, vomiting, sweating, dizziness, and pallor were noted by the parent. The parent was instructed to call if the child had any vagal symptoms. Documentation of any vagal symptoms was completed by the parent and child on a data-collection form at the time of occurrence. Data was analyzed as a percentage of subjects experiencing vagal symptoms during flush with NS and USP glycerin.|Data collection started with the first flush administered following discharge from the hospital and was collected with every subsequent flush through completion of the study, an average of 115 days.|The data from a total of 5 participants were analyzed for each arm of the study.|||Participants|||Count of Participants
2577816|NCT02435069|Secondary|Cramping With Flush|Cramping with flush was measured using the Wong Baker Faces Pain Rating Scale (WBFPRS). The WBFPRS has undergone extensive testing and has well established psychometrics in the pediatric population. The scale ranges from 0 (very happy without pain) to 10 (the worse pain imaginable). Each pain level is associated with a facial expression. The child is asked to choose the face that best describes his/her level of discomfort (ordinal data). The parent was instructed to call if the child had flushing regimen-associated discomfort greater than a 4 on the WBFPRS. Documentation of pain severity was completed by the parent and child on a data-collection form at the time of occurrence. Descriptive statistics including mean and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Descriptive and inferential statistics were calculated on the last data point in the dosing phase.|Data analysis was completed on data obtained during the last flush in both the NS and USP Glycerin dosing phase|The data from a total of 5 participants were analyzed for each arm of the study.|||units on a scale||Standard Deviation|Mean
2577817|NCT02435069|Secondary|Change in Stool Calprotectin Levels Assessed Through Comparing Levels Obtained Following Completion of NS and USP Glycerin Dosing Phases With the Baseline Value For Each Subject|Stool calprotectin was used to evaluate the impact of NS and USP Glycerin antegrade flush on colonic health. Calprotectin levels were obtained at baseline and following completion of the NS and USP Glycerin dosing phase of the study. Descriptive data analysis included mean and standard deviation for each flush regimen. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Both descriptive and inferential data analysis was calculated on the difference in calprotectin levels between samples obtained at baseline and samples obtained following the completion of the NS and USP Glycerin flush (value at completion of dosing phase - baseline value). The assumption was the length of each dosing phase was sufficient to achieve a credible active washout period and therefore levels obtained at the end of a phase reflected flushing regimen effects colonic health regardless of flush order.|Collection dates included a baseline sample (week 1) and at the completion of the dosing trail for both NS and USP glycerin for a total of 3 samples|The data from a total of 5 participants were analyzed for NS and 4 participants for USP Glycerin|||μg/g||Standard Deviation|Mean
2577818|NCT02435069|Secondary|Number of Participants With Any Electrolyte Abnormality|Evaluated impact of NS and USP Glycerin antegrade flush on serum electrolytes using a blood test called a Basic Metabolic Panel. Data analysis limited to percentage of subjects demonstrating any electrolyte abnormality on NS or USP glycerin.|Collection dates included a baseline sample (week 1) and at the completion of the dosing trail for both NS and USP glycerin for a total of 3 samples|The data from a total of 5 participants were analyzed for each arm of the study.|||Participants|||Count of Participants
2577819|NCT02435069|Secondary|Flush Volume|Flush volume was measured in mL/flush using a graduated cylinder and recorded by the parent or child with each flush and later calculated in mL/kg. Data derived from the last flush of the completed dosing phase of both NS and USP Glycerin were used to calculate flush volume. Descriptive analysis included mean, median, range, and standard deviation. Reported data excludes subjects who failed to gain and maintain continence on either flushing regimen.|Data for analysis was collected from the last flush of the NS and USP Glycerin dosing phase of the study|Subjects limited to those who gained continence (2 saline, 4 USP Glycerin). One subject gained and maintained continence on saline in both the dosing and maintenance phases of the study and one subject who gained continence during the dosing phase of the study but failed to maintain continence on saline during the maintenance phase of the study.|||mL/flush||Standard Deviation|Mean
2577820|NCT02435069|Secondary|NS and USP Glycerin Flush Solution Dosing Frequency Necessary to Achieve Continence|Flush administration frequency necessary to achieve continence was recorded as a single measure per subject per flush solution obtained as the number of flushes in the last three days of each dosing phase and recorded as either daily (1), every other day (2), or every third day (3). The larger the value, the less frequent the flush, the better the clinical outcome. Dosing frequency was measured using direct observational recording completed by the parent or child. Descriptive analysis included mean, and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Descriptive and inferential statistics were calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.|Frequency of administration data was collected as the total number of flushes recieved over the last three days of each dosing phase for both NS and USP Glycerin and recorded as either daily (1), every other day (2), or every third day|The data from a total of 5 participants were analyzed for each arm of the study.|||Flush administration/day||Standard Deviation|Mean
2577821|NCT02435069|Primary|Fecal Soiling - Quantitative Count Detailing the Number of Episodes of Fecal Incontinence Per Day on NS and USP Glycerin|Fecal soiling was defined as non-toilet elimination, which was tracked and documented by the parent/child as direct event recording and tallied as the number of pairs of underwear/protective undergarments soiled with stool per day. Descriptive statistics included mean and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05, calculated on the data from the last day of the completed NS and USP Glycerin phases of the study. Power analysis conducted using data from this study with α = 0.5, power of .80, correlation between two means of .598, and effect size of 1.554 estimated a sample size of 11 would be needed to minimize the risk of a Type II error to (20%).|Data collection began following consent and procedural training and was collected daily from day 1 for the duration of the study, an average of 135 days.|The data from a total of 5 participants were analyzed for each arm of the study.|||underwear soiled/day|Fecal Soiling|Standard Deviation|Mean
2577822|NCT02435069|Primary|Fecal Soiling - Number of Participants That Gained and Maintained Continence on Each Flushing Regimen|Fecal soiling was defined as non-toilet elimination, which was tracked and documented by the parent/child as direct event recording and tallied as the number of pairs of underwear/protective undergarments soiled with stool per day. The purpose of this outcome measure was to document the number of individuals who gained continence on NS and USP glycerin. Descriptive statistics was limited to percentage of total participants who achieved continence on each flushing regimen. Data was calculated on the last data point in the final phase for both the NS and USP glycerin flush.|Data collection started following consent and procedural training and was collected daily from day 1 for the duration of the study, an average of 135 days.|The data from a total of 5 participants were analyzed for each arm of the study.|||Participants|||Count of Participants
2577823|NCT02434939|Secondary|Incidence of Treatment Failure by Treatment Group.|Requiring more than two doses of the study medication provided for adequate pain control|120 minutes||||participants|||Number
2577833|NCT02434770|Primary|Number of Participants Experiencing Adverse Events|"Adverse events were graded as mild (Grade 1 = No or minimal interference with usual activities; no medical intervention/therapy required), moderate (Grade 2 = Greater than minimal interference with usual activities; no or minimal medical intervention/therapy required), severe (Grade 3 = Marked limitation in ability to perform usual activities; medical intervention/therapy required), or potentially life-threatening (Grade 4 = Inability to perform basic functions OR Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death).~The overall number of participants who experienced any adverse event is reported. Grades are based on maximum severity per participant."|From the time of the first vaccination through 28 days after each vaccination (up to Day 126).|Safety population|||Participants|||Count of Participants
2577824|NCT02434939|Secondary|Incidence of Side Effects, Including Outlying Vital Signs|The patient will be assessed for vital signs (blood pressure, heart rate, respiratory rate, oxygen saturation), Ramsay Sedation Scale (RSS) score at 5,10,20 minutes following medication administration and then every 20 minutes until a total of 120 minutes from the first dose of study medication. outlying vital signs recorded.( systolic Blood pressure less than 90mmHg or greater than 150mmHg, Heart rate less than 50bpm or greater than 150bpm, oxygen saturation below 90%, respiratory rate below 9breaths/minute or greater than 40breaths/minute and RSS of 1 or greater than 3) The RSS was used to asses the level of agitation or sedation caused by the intervention .the scale ranges from 1(anxious/agitated) to 6( no response to stimulus-deep sedation) with 2 being the optimal (cooperative, oriented and tranquil).A checklist for side effects like airway problems, allergic reactions, salivation, dysphoria,nystagmus, respiratory/cardiac arrest, awakening hallucinations, nausea/vomiting was used|5, 10, 20, 40, 60, 80, 100, 120 minutes post drug administration||||participants|||Number
2577825|NCT02434939|Secondary|Time to Maximal Analgesic Effect and Duration of Action of Ketamine|"Following dosage with study medication, the amount of time taken to demonstrate the maximal change in the patient's NRS pain score.~Maximal change in NRS pain score is to be defined as the largest change from patient's baseline pain score. Duration of maximal change is how long the patient's pain score remained at this level."|5, 10, 20, 40, 60, 80, 100, 120 minutes post drug administration||||minutes||Standard Deviation|Mean
2577826|NCT02434939|Primary|Maximal Change in NRS Pain Scores as a Percentage of Baseline NRS Pain Score.|Our primary outcome measurement was the maximum change on the verbal NRS pain scale compared with their initial score (baseline). The NRS was used to measure a patient's subjective level of pain on a scale from 0 (representing no pain at all) to 10 (the worst pain imaginable) using whole numbers. The NRS score was documented just prior to the administration of the study drug (time zero). After infusion of the study drug was complete, NRS scores were documented at 5, 10, 20, and then every 20 minutes thereafter up to 120 minutes. We stopped recording NRS scores prior to 120 minutes if the patient requested a third dose of the study drug, withdrew consent or developed a severe adverse effect.|5, 10, 20,25,30, 40,45,50 60, 80, 100, 120 minutes post drug adminstration|3 patients in ketamine arm withdrew consent after 20 minutes in to the study while 1 patient in morphine arm was discontinued due to urticarial for fear of a worsened reaction if reexposed to the drug as he required a second dose|||percent change from baseline NRS score.||Standard Deviation|Mean
2577827|NCT02434770|Secondary|Anti-Rotavirus Immunoglobulin A (IgA) Geometric Mean Titers|"Anti-rotavirus immunoglobulin A titers were measured to assess the impact of concomitant administration of BBIBP liquid bOPV on immune responses to other Expanded Programme on Immunization (EPI) vaccines in comparison to that of the WHO pre-qualified bOPV, 4 weeks after the fourth vaccination.~The ELISA assay for antibodies to rotavirus was performed at the Children's Hospital Medical Center (CCHMC) using a validated in-house assay."|4 weeks post vaccination 4 (Week 18)|Participants who received all 4 bOPV vaccinations and ≥ 2 Rotavirus vaccinations at least 21 days prior to blood draw|||titer||95% Confidence Interval|Geometric Mean
2577828|NCT02434770|Secondary|Number of Infants With Anti-hepatitis B Surface Antigen (HBsAg) Seroprotection|Seroprotection was defined as a HBsAg titer ≥ 1:10 The ELISA assays for serum antibodies to HBsAg were performed at the Children's Hospital Medical Center (CCHMC). The HBsAb assay was a qualified assay using a kit from BioRad.|28 days after vaccination 4|Participants who received all 4 bOPV vaccinations and ≥ 3 hepatitis B virus vaccinations at least 21 days prior to blood draw.|||Participants|||Count of Participants
2577829|NCT02434770|Secondary|Anti-hepatitis B Surface Antigen (HBsAg) Geometric Mean Titers|"Anti-HBsAg titers were measured to assess the impact of concomitant administration of BBIBP liquid bOPV on immune responses to other Expanded Programme on Immunization (EPI) vaccines in comparison to that of the WHO pre-qualified bOPV, 4 weeks after the fourth vaccination.~The enzyme-linked immunosorbent assay (ELISA) assays for serum antibodies to HBsAg were performed at the Children's Hospital Medical Center (CCHMC). The HBsAb assay was a qualified assay using a kit from BioRad."|4 weeks post vaccination 4 (Week 18)|Participants who received all 4 bOPV vaccinations and ≥ 3 hepatitis B virus vaccinations at least 21 days prior to blood draw.|||titer||95% Confidence Interval|Geometric Mean
2577830|NCT02434770|Primary|Number of Infants With Serotype-specific Anti-polio Neutralizing Antibody Seroconversion 4 Weeks After Last Dose|"The assays for determination of anti-poliovirus neutralizing antibodies at the National Institutes for Food and Drug Control (NIFDC) were validated.~Seroconversion was defined as a titer ≥ 1:8 if seronegative at screening, otherwise a ≥ 4-fold increase in adjusted titers (i.e., adjusted for the decay in maternal antibodies, based on a half life of 28 days)."|4 weeks post vaccination 4 (Week 18)|Per Protocol Immunogenicity (PP-IMM) population|||Participants|||Count of Participants
2577831|NCT02434770|Primary|Anti-polio Neutralizing Antibody Geometric Mean Titers: Serotype 3|"The assays for determination of anti-poliovirus neutralizing antibodies at the National Institutes for Food and Drug Control (NIFDC) were validated.~Anti-polio antibody titer four weeks after the fourth vaccination was adjusted for the decrease in maternal antibodies based on a half-life of 28 days."|Screening and 4 weeks post vaccination 4 (Week 18)|Per Protocol Immunogenicity (PP-IMM) population|||titer||95% Confidence Interval|Geometric Mean
2577832|NCT02434770|Primary|Anti-polio Neutralizing Antibody Geometric Mean Titers (GMT): Serotype 1|"The assays for determination of anti-poliovirus neutralizing antibodies at the National Institutes for Food and Drug Control (NIFDC) were validated.~Anti-polio antibody titer four weeks after the fourth vaccination was adjusted for the decrease in maternal antibodies based on a half-life of 28 days."|Screening and 4 weeks post vaccination 4 (Week 18)|Per Protocol Immunogenicity (PP-IMM) population includes all enrolled participants who were randomized, received all 4 doses of bOPV per the assigned treatment group, had post-vaccination immunogenicity measurement(s),and no major protocol violations that would have potentially interfered with the immunogenicity assessment of the study vaccine.|||titer||95% Confidence Interval|Geometric Mean
2577865|NCT02434497|Secondary|Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline Non-HDL-C|participants|95% Confidence Interval|Geometric Mean
2577866|NCT02434497|Secondary|Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline TG|participants|95% Confidence Interval|Geometric Mean
2581338|NCT02393547|Primary|Post Cessation Weight Change|change in weight from baseline to week 12|12 weeks|subjects (n=10) who met criteria for prolonged smoking abstinence at week 12|||kg||Standard Deviation|Mean
2577834|NCT02434770|Primary|Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity|"Solicited systemic reactogenicity events evaluated during the week after each vaccination included fever, vomiting, diarrhea, decreased appetite/ poor feeding, irritability, and decreased activity. Reactions were recorded by participant's parents via memory aid. Each event was graded as:~Mild (Grade 1): No or minimal interference with usual activities; no medical intervention/therapy required, Moderate (Grade 2): Greater than minimal interference with usual activities; no or minimal medical intervention/therapy required, Severe (Grade 3): Marked limitation in ability to perform usual activities; medical intervention/therapy required, or Potentially life-threatening (Grade 4): Inability to perform basic functions OR Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death.~The overall number of participants who experienced any systemic reaction is reported. Grades are based on maximum severity per participant."|7 days after each vaccination (Weeks 0, 6, 10, and 14)|The safety population included all enrolled participants who had safety data available, assigned according to the actual treatment received at Day 0.|||Participants|||Count of Participants
2577835|NCT02434523|Secondary|Lost to Follow up||8 weeks|number of subjects in each arm who were lost to follow up|||participants|||Number
2577836|NCT02434523|Secondary|Side Effects|number of patients with side effects, type of side effects|8 weeks||||participants|||Number
2577837|NCT02434523|Secondary|Voice Handicap Index|Voice handicap index change in score after treatment Possible range: 0 to 40 Higher values indicate worse symptoms / outcomes|8 weeks||||units on a scale||Standard Deviation|Mean
2577838|NCT02434523|Primary|Reflux Symptom Index|Reflux symptom index change in score after treatment Range possible: 0 to 45 Higher values indicate worse symptoms / outcomes|8 weeks|Patients who completed treatment and post-treatment questionnaire|||units on a scale||Standard Deviation|Mean
2577839|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Vital Signs||96 weeks||||participants|participants||Number
2577840|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Physical Exams, Skin||96 weeks||||participants|participants||Number
2577841|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities||96 weeks||||participants|participants||Number
2577842|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck||96 weeks||||participants|participants||Number
2577843|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance||96 weeks||||participants|participants||Number
2577844|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular||96 weeks||||participants|participants||Number
2577845|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal ECG, Abnormalities||96 weeks||||participants|participants||Number
2577846|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein||96 weeks||||participants|participants||Number
2577847|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood||96 weeks||||participants|participants||Number
2577848|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones||96 weeks||||participants|participants||Number
2577849|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN||96 weeks||||participants|participants||Number
2577850|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN||96 weeks||||participants|participants||Number
2577851|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN||96 weeks||||participants|participants||Number
2577852|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN||96 weeks||||participants|participants||Number
2577853|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN||96 weeks||||participants|participants||Number
2577854|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN||96 weeks||||participants|participants||Number
2577855|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN||96 weeks||||participants|participants||Number
2577856|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN||96 weeks||||participants|participants||Number
2577857|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN||96 weeks||||participants|participants||Number
2577858|NCT02434497|Secondary|Pharmacokinetic Profile in Terms of Trough Concentrations in Pediatric HoFH Taking a Daily Dose of Rosuvastatin 40mg||Up to 22 months||||ng/mL|||Number
2577859|NCT02434497|Secondary|Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline ApoB/ApoA-1|participants|95% Confidence Interval|Geometric Mean
2577860|NCT02434497|Secondary|Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline ApoA-1|participants|95% Confidence Interval|Geometric Mean
2577861|NCT02434497|Secondary|Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline ApoB|participants|95% Confidence Interval|Geometric Mean
2577862|NCT02434497|Secondary|Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline Non-HDL-C/HDL-C|participants|95% Confidence Interval|Geometric Mean
2577863|NCT02434497|Secondary|Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline TC/HDL-C|participants|95% Confidence Interval|Geometric Mean
2577864|NCT02434497|Secondary|Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline LDL-C/HDL-C|participants|95% Confidence Interval|Geometric Mean
2593116|NCT02249104|Secondary|Mean Change From Baseline in Non-inflammatory Lesion Count||Baseline and 8 weeks||||Lesions counted||Standard Deviation|Mean
2577868|NCT02434497|Secondary|Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline HDL-C|participants|95% Confidence Interval|Geometric Mean
2577869|NCT02434497|Secondary|Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis||Up to 22 months||||% change from baseline LDL-C|participants|95% Confidence Interval|Geometric Mean
2577870|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN||96 weeks||||participants|participants||Number
2577871|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN||96 weeks||||participants|participants||Number
2577872|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN||96 weeks||||participants|participants||Number
2577873|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN||96 weeks||||participants|participants||Number
2577874|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN||96 weeks||||participants|participants||Number
2577875|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN||96 weeks||||participants|participants||Number
2577876|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN||96 weeks||||participants|participants||Number
2577877|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN||96 weeks||||participants|participants||Number
2577878|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN||96 weeks||||participants|participants||Number
2577879|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN||96 weeks||||participants|participants||Number
2577880|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN||96 weeks||||participants|participants||Number
2577881|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN||96 weeks||||participants|participants||Number
2577882|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN||96 weeks||||participants|participants||Number
2577883|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN||96 weeks||||participants|participants||Number
2577884|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN||96 weeks||||participants|participants||Number
2577885|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN||96 weeks||||participants|participants||Number
2577886|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN||96 weeks||||participants|participants||Number
2577887|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN||96 weeks||||participants|participants||Number
2577888|NCT02434497|Primary|Safety and Tolerability in Terms of Growth, Weight||96 weeks||||kg|participants|Standard Deviation|Mean
2577889|NCT02434497|Primary|Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score)|Height z-score is a dimensionless quantity derived by subtracting the population mean from the individual raw score, and then deviding the difference by the pouulation SD of the reference population. This indicates how many SDs and observation is above or below the general population mean.|96 weeks||||standard deviations|participants|Standard Deviation|Mean
2577890|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormalitites in Sexual Maturation||96 weeks||||participants|||Number
2577891|NCT02434497|Primary|Safety and Tolerability in Terms of Growth, Height||96 weeks||||cm|participants|Standard Deviation|Mean
2577892|NCT02434497|Primary|Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN)||96 weeks||||participants|participants||Number
2577893|NCT02434497|Primary|Safety and Tolerability in Terms of Number of Participants Who Had Adverse Events, Discontinuations Due to Adverse Events||96 weeks||||participants|||Number
2577894|NCT02434497|Primary|The Number of Participants Who Experianced Adverse Events and Serious Adverse Events||96 weeks||||participants|||Number
2577895|NCT02434471|Primary|Noise Scores|Three investigators will independently evaluate MRI examinations. They will assign noise scores between respiratory triggered and corresponding breath hold acquisitions. 1 = no noise artifact; 2 = minimal noise artifact, no effect on diagnostic quality; 3 = moderate noise artifact with some, but not severe, effect on diagnostic quality; 4 = severe noise artifact, images degraded but interpretable; and 5 = severe noise artifact, images nondiagnostic.|During MRI, up to 60 minutes|The same 25 subjects were used for each group.|||scores on a scale||Standard Deviation|Mean
2577896|NCT02434471|Primary|Motion Artifact Scores|Three investigators will independently evaluate MRI examinations. They will assign motion scores between respiratory triggered and corresponding breath hold acquisitions. 1 = no motion artifact; 2 = minimal motion artifact, no effect on diagnostic quality; 3 = moderate motion artifact with some, but not severe, effect on diagnostic quality; 4 = severe motion artifact, images degraded but interpretable; and 5 = extensive motion artifact, images nondiagnostic.|During MRI, up to 60 minutes|The same 25 subjects were used in both groups.|||scores on a scale||Standard Deviation|Mean
2577897|NCT02434328|Secondary|Percentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye|Subretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal hemorrhage is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Baseline, Weeks 12, 48, 96|FAS with non-missing values. Number Analyzed represents the number of subjects with a value for both baseline and the specific post-baseline visit.|||percentage of subjects|||Number
2577898|NCT02434328|Secondary|Percentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye|Intraretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal hemorrhage is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Baseline, Weeks 12, 48, 96|FAS with non-missing values. Number Analyzed represents the number of subjects with a value for both baseline and the specific post-baseline visit.|||percentage of subjects|||Number
2577899|NCT02434328|Secondary|Percentage of Subjects With Induced or Boosted Anti-drug Antibody (ADA) Status at Week 48 (Brolucizumab Only)|Serum samples were collected and assessed for anti-drug antibody status. Subjects were categorized as ADA negative when one of the following was met: ADA negative at all time points (predose and postdose); ADA negative at predose and no titer values above 10 at all other time points; or ADA titer of 10 at predose but negative at all other time points. ADA induced was defined as ADA negative at predose with postdose titer value greater than or equal to a titer of 30 at any timepoint. ADA boosted was defined as ADA positive at predose with postdose titer values that increased by at least two dilutions (9-fold) from their respective predose value at any time point.|Week 48|Safety Analysis Set - Observed|||percentage of subjects|||Number
2577900|NCT02434328|Secondary|Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96|The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) is a validated questionnaire that collects 25 vision-targeted responses from AMD subjects. The 25 questions pertain to global vision rating (1), difficulty with near vision activities (3), difficulty with distance vision activities (3), limitations in social functioning due to vision (2), role limitations due to vision (2), dependency on others due to vision (3), mental health symptoms due to vision (4), driving difficulties (3), limitations with peripheral (1) and color vision (1), and ocular pain (2). Each response is converted to a 0 to 100 sub-scale, with the lowest and highest possible scores set at 0 and 100 points, respectively. The overall composite score (0 to 100) is obtained by averaging the 25 sub-scale scores. A high score represents better functioning.|Baseline, Weeks 24, 48, 72, 96|FAS - Observed. Number analyzed is the number of subjects with a value for both baseline and the specific post-baseline visit.|||score on a scale||Standard Deviation|Mean
2577901|NCT02434328|Secondary|"Percentage of Subjects With Disease Activity Present (q8 Treatment Need = Yes) at Week 16 - Study Eye"|A disease activity assessment (DAA) was performed to identify q8 treatment need. 95% confidence interval (CI) for binomial proportions is based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. Hypothesis testing not pre-specified.|Week 16|FAS - ‘efficacy/safety’ approach. Censored data attributable to lack of efficacy and/or safety are imputed with q8w need = Yes at the next disease activity assessment visit.|||percentage of subjects||95% Confidence Interval|Number
2577902|NCT02434328|Secondary|Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid (Central Subfield) at Each Post-baseline Visit - Study Eye|Subretinal fluid and intraretinal fluid were assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal and/or intraretinal fluid is an indicator of underlying disease. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2577903|NCT02434328|Secondary|Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye|Sub-retinal pigment epithelium (RPE) fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of sub-RPE fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2577904|NCT02434328|Secondary|Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye|Intraretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2577905|NCT02434328|Secondary|Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye|Subretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2577906|NCT02434328|Secondary|Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye|CSFTns was assessed using SD-OCT. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||micrometers||Standard Deviation|Mean
2577907|NCT02434328|Secondary|Change From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye|CNV lesion size (the area of new blood vessels in the choroid layer of the retina) size was measured using fluorescein angiography (FA). A negative change value indicates a reduction in lesion size, whereas a positive change value indicates an increase. An increase in CNV lesion size may indicate progression of the underlying disease. Only one eye (study eye) contributed to the analysis.|Baseline, Weeks 12, 48, 96|FAS - LOCF|||millimeters squared||Standard Deviation|Mean
2577908|NCT02434328|Secondary|Average Change From Baseline in CSFT Over the Period Week 4 Through Week 48/96 - Study Eye|CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||micrometers||Standard Deviation|Mean
2580230|NCT02408445|Secondary|Change in Fat Free Mass|Fat free mass (lean mass) will be measured using air displacement plethysmography (PEA POD) at the beginning and end of the study period.|Baseline and 3 months||||kg||Standard Deviation|Mean
2577909|NCT02434328|Secondary|Average Change From Baseline in CSFT Over the Period Week 84 Through Week 96 - Study Eye|CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.|Baseline, Weeks 84, 88, 92, 96|FAS - LOCF|||micrometers||Standard Deviation|Mean
2577910|NCT02434328|Secondary|Average Change From Baseline in CSFT Over the Period Week 36 Through Week 48 - Study Eye|CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.|Baseline, Weeks 36, 40, 44, 48|FAS - LOCF|||micrometers||Standard Deviation|Mean
2577911|NCT02434328|Secondary|Change From Baseline in Central Subfield Thickness (CSFT) at Each Post-baseline Visit - Study Eye|CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT), a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||micrometers||Standard Deviation|Mean
2577912|NCT02434328|Secondary|Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly (0-100 letters). A score of 65 to 70 letters represents a low to moderate visual acuity. Baseline was defined as the last measurement prior to first treatment. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2577913|NCT02434328|Secondary|Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2577914|NCT02434328|Secondary|Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2577915|NCT02434328|Secondary|Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2577916|NCT02434328|Secondary|Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2577917|NCT02434328|Secondary|Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2577918|NCT02434328|Secondary|Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% confidence interval (CI) for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2577951|NCT02433678|Other Pre-specified|Change in Hypertension Mediators|Plasma concentrations measurement of Angiotensinogen through enzyme-linked immunosorbent assay|12 weeks|Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm|||ug/mL||Standard Deviation|Mean
2577919|NCT02434328|Secondary|Average Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Weeks 84, 88, 92, 96|FAS - LOCF|||letters||Standard Deviation|Mean
2577920|NCT02434328|Secondary|Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||letters||Standard Deviation|Mean
2577921|NCT02434328|Secondary|Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||letters||Standard Deviation|Mean
2577922|NCT02434328|Secondary|Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||letters||Standard Deviation|Mean
2577923|NCT02434328|Secondary|Proportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need During the Initial q12w Cycle (Week 16, Week 20)|"Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks q12w, after the initial three loading injections every 4 weeks q4w). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified."|Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96|FAS - efficacy/safety approach|||proportion of subjects||95% Confidence Interval|Number
2577924|NCT02434328|Secondary|Proportion of Subjects With Positive q12 Treatment Status up to Week 96|"Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks q12w, after the initial three loading injections every 4 weeks q4w). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified."|Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96|FAS - efficacy/safety approach|||proportion of subjects||95% Confidence Interval|Number
2577925|NCT02434328|Secondary|Proportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Treatment Need During the Initial q12w Cycle (Week 16, Week 20)|"Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks q12w, after the initial three loading injections every 4 weeks q4w). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified."|Weeks 16, 20, 28, 32, 40, 44, 48|FAS - efficacy/safety approach|||proportion of subjects||95% Confidence Interval|Number
2577926|NCT02434328|Secondary|Proportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 48|"Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks q12w, after the initial three loading injections every 4 weeks q4w). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w (one injection every 8 weeks) need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. This outcome measure was pre-specified for brolucizumab 6 mg arm only. Hypothesis testing not pre-specified."|Weeks 16, 20, 28, 32, 40, 44, 48|FAS - efficacy/safety approach|||proportion of subjects||95% Confidence Interval|Number
2577952|NCT02433678|Secondary|Changes in Expression of Inflammatory Mediators|Tumor necrosis factor alpha measurement in mononuclear through real time polymerase chain reaction|12 weeks|Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm|||arbitrary unit||Standard Deviation|Mean
2577927|NCT02434328|Secondary|Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. For each subject, this endpoint was defined as the average of the changes from baseline to Weeks 36, 40, 44, and 48. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Weeks 36, 40, 44, 48|FAS - LOCF|||letters||Standard Deviation|Mean
2577928|NCT02434328|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Week 48|Full Analysis Set (FAS) - Last Observation Carried Forward (LOCF)|||letters||Standard Deviation|Mean
2577929|NCT02434146|Primary|Time to Onset of Grade 3 Oral Mucositis|Will be analyzed using a parametric (one-parameter exponential) cure rate model. Will be performed in both the extended cohort as well as in the historical controls.|Time between the first date of radiation or cyclophosphamide treatment to the date of the onset of grade 3 oral mucositis, assessed up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and time to onset of grade 3 oral mucositis could not be analyzed.||||||
2577930|NCT02434146|Primary|Time to Onset of Grade 2 Oral Mucositis|Will be analyzed using a parametric (one-parameter exponential) cure rate model. Will be performed in both the extended cohort as well as in the historical controls.|Time between the first date of radiation or cyclophosphamide treatment to the date of the onset of grade 2 oral mucositis, assessed up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and time to onset of grade 2 oral mucositis could not be analyzed.||||||
2577931|NCT02434146|Primary|Recommended Phase IIa Dose|The dose of topical phenylephrine solution which will be recommended for a larger follow-up phase II efficacy study will be established after the dose cohort at the MTD has been expanded to a total of 12 patients.|During the conditioning regimen (radiation and cyclophosphamide treatment), which is anticipated to last 1 week.|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and the dose of topical phenylephrine solution for a larger follow-up phase II efficacy study could not be recommended.||||||
2577932|NCT02434146|Primary|Maximum Tolerated Dose (MTD), Defined as the Highest Dose Level of Phenylephrine Applied to the Oral Mucosa Where 0/3, 0/6, or 1/6 Patients Experience a Dose-limiting Toxicity|Determine Maximum Tolerated Dose (MTD), the highest dose level of phenylephrine applied to the oral mucosa|During the conditioning regimen (radiation and cyclophosphamide treatment), which is anticipated to last 1 week.|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and MTD could not be determined.||||||
2577933|NCT02434146|Primary|Incidence of Adverse Events, Graded According to the Common Terminology Criteria for Adverse Events Version 4.0|Adverse events (AEs) will be presented in the summary tables by preferred term nested within the System Organ Class. Verbatim description, preferred term, and system organ class for all AEs will be contained in the patient data listings. All AEs occurring after enrollment and throughout the study period will be recorded. Each toxicity event will be assigned an attribution: unrelated, unlikely, possibly, probably, or definitely phenylephrine treatment related.|Up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and no study conclusions could be made.||||||
2577934|NCT02434146|Primary|Efficacy Response Rate for Preventing Oral Mucositis With Sufficient Accuracy|If a patient experiences no higher than grade 2 oral mucositis, then s/he will be defined as a responder. If a patient experiences grade >= 3 oral mucositis, s/he will be defined as a non-responder. Specifically, the efficacy response rate will be estimated with a standard error of less than 15% and the length of the 95% confidence interval will be less than 50%. The efficacy response rate will be summarized in tabular format. The Wilson score method will be used to calculate the 95% confidence interval for the efficacy response rate for the extended cohort.|Up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and the efficacy response rate could not be estimated.||||||
2577935|NCT02434146|Primary|Duration of Grade 3 Oral Mucositis|If the grade 3 oral mucositis has not been resolved (to a grade < 3) by the last day of toxicity assessment, then the duration will be censored at the last date of toxicity assessment. Will be analyzed using the Kaplan-Meier method. The median duration of grade 2/grade 3 oral mucositis will be calculated and reported along with the corresponding 95% confidence interval. This analysis will be performed in both the extended cohort as well as in the historical controls.|Date of onset of grade 3 oral mucositis to the date of resolution to grade < 3 oral mucositis, assessed up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and the median duration of oral mucositis could not be analyzed.||||||
2577936|NCT02434146|Primary|Duration of Grade 2 Oral Mucositis|If the grade 2 oral mucositis has not been resolved (to a grade < 2) by the last day of toxicity assessment, then the duration will be censored at the last date of toxicity assessment. Will be analyzed using the Kaplan-Meier method. The median duration of grade 2/grade 3 oral mucositis will be calculated and reported along with the corresponding 95% confidence interval. This analysis will be performed in both the extended cohort as well as in the historical controls.|Date of onset of grade 2 oral mucositis to the date of the resolution of the grade 2 oral mucositis, assessed up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and the median duration of oral mucositis could not be analyzed.||||||
2577937|NCT02434146|Primary|Area Under the Curve (AUC) for the Oral Mucositis Severity|The mucositis AUC will be estimated using the trapezoid method and summarized in terms of means, standard deviation, median and range. This analysis will be performed in both the extended cohort as well as in the historical controls.|Up to 3 months|This study was closed prematurely due to decreased numbers of eligible subjects. The full target accrual number was not achieved, and AUC could not be estimated or analyzed.||||||
2577938|NCT02433834|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ-5) on Day 15|The ACQ-5 measures 5 symptoms (woken at night by symptoms, wake in the morning with symptoms, limitation of daily activities, shortness of breath, and wheeze). The scale is 0-6, where 0=minimum and 6=maximum|Day 1-Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population. The modified intent-to-treat (mITT) population included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they received.|||Scores on a scale||Standard Error|Least Squares Mean
2577939|NCT02433834|Secondary|Change From Baseline in Average Daily Rescue Medication Use Over 14 Days|Daily pre-dose PEFR and daily post-dose PEFR will each be calculated as the average of the AM and PM measurements recorded for a given day. If either the AM or PM assessment is missing, only the single measurement will be used. Analyses of average daily pre-dose PEFR, average daily post-dose PEFR, and rescue Ventolin HFA usage will use the average of the non-missing daily values recorded in the subject diaries over each week and over the last week of treatment within each period.|Day 1-Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population was a subset of the Intent-to-Treat (ITT) Population and included all subjects who received treatment, had post-treatment efficacy data from at least two treatment periods, and did not hav e a major protocol violation that would preclude the use of data from these periods.|||Puffs||Standard Error|Least Squares Mean
2577940|NCT02433834|Secondary|Change From Baseline in Average Daily Post-dose PEFR Over 14 Days|Daily pre-dose PEFR and daily post-dose PEFR will each be calculated as the average of the AM and PM measurements recorded for a given day. If either the AM or PM assessment is missing, only the single measurement will be used. Analyses of average daily pre-dose PEFR, average daily post-dose PEFR, and rescue Ventolin HFA usage will use the average of the non-missing daily values recorded in the subject diaries over each week and over the last week of treatment within each period.|Day 1-Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population was a subset of the Intent-to-Treat (ITT) Population and included all subjects who received treatment, had post-treatment efficacy data from at least two treatment periods, and did not hav e a major protocol violation that would preclude the use of data from these periods.|||L/min||Standard Error|Least Squares Mean
2577941|NCT02433834|Secondary|Change From Baseline in Average Daily Pre-dose PEFR Over 14 Days|Change from baseline in average daily pre-dose peak expiratory flow rate (PEFR) over 14 days Daily pre-dose PEFR and daily post-dose PEFR will each be calculated as the average of the AM and PM measurements recorded for a given day. If either the AM or PM assessment is missing, only the single measurement will be used. Analyses of average daily pre-dose PEFR, average daily post-dose PEFR, and rescue Ventolin HFA usage will use the average of the non-missing daily values recorded in the subject diaries over each week and over the last week of treatment within each period.|Day 1-Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population was a subset of the Intent-to-Treat (ITT) Population and included all subjects who received treatment, had post-treatment efficacy data from at least two treatment periods, and did not hav e a major protocol violation that would preclude the use of data from these periods.|||L/min||Standard Error|Least Squares Mean
2577942|NCT02433834|Secondary|FEV1 AUC0-3 on Day 15|FEV1 AUC0-3 is the area under the curve for the change from baseline in FEV1 calculated using the trapezoidal rule. All observed data will be used with the trapezoidal rule to calculate AUC. To aid in interpretation, all AUC values will be normalized by dividing the AUC by the time from the first to the last non-missing value (typically 3 hours).|Day 1-Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population was a subset of the Intent-to-Treat (ITT) Population and included all subjects who received treatment, had post-treatment efficacy data from at least two treatment periods, and did not hav e a major protocol violation that would preclude the use of data from these periods.|||Liter||Standard Error|Least Squares Mean
2577943|NCT02433834|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1 on Day 15|Change from baseline in morning pre-dose trough FEV1 on Day 15|Day 1-Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population was a subset of the Intent-to-Treat (ITT) Population and included all subjects who received treatment, had post-treatment efficacy data from at least two treatment periods, and did not hav e a major protocol violation that would preclude the use of data from these periods.|||Liter||Standard Error|Least Squares Mean
2577944|NCT02433834|Primary|Peak Change From Baseline in FEV1 Within 3 Hours Post-dosing on Day 15|Forced Expiratory Volume in 1 second (FEV1) within 3 hours post-dosing on Day 15|From Day 1 to Within 3 hours post dosing on Day 15 in each of 5 treatment periods|Modified Intent-to-Treat (mITT) population was a subset of the Intent-to-Treat (ITT) Population and included all subjects who received treatment, had post-treatment efficacy data from at least two treatment periods, and did not hav e a major protocol violation that would preclude the use of data from these periods.|||Liter||Standard Error|Least Squares Mean
2577945|NCT02433678|Other Pre-specified|Change in Hypertension Mediators|Plasma concentration measurment of Cyclic adenosine monophosphate through enzyme linked immunosorbent assay|12 week|Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm|||pmol/mL||Standard Deviation|Mean
2577946|NCT02433678|Other Pre-specified|Change in Hypertension Mediators|Plasma concentration measurement of Cyclic guanosine monophosphate through enzyme linked immunosorbent assay|12 weeks|Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm|||pmol/mL||Standard Deviation|Mean
2577947|NCT02433678|Other Pre-specified|Change in Hypertension Mediators|Plasma concentration measurement of B-type natriuretic peptide through enzyme linked immunosorbent assay|12 weeks|Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm|||pg/mL||Standard Deviation|Mean
2577948|NCT02433678|Other Pre-specified|Change in Hypertension Mediators|Plasma concentration measurement of Atrial natriuretic peptide through enzyme linked immunosorbent assay|12 weeks|Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm|||pg/mL||Standard Deviation|Mean
2577949|NCT02433678|Other Pre-specified|Change in Hypertension Mediators|Plasma concentration measurement of Renin through enzyme-linked immunosorbent assay|12 weeks|Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm|||pg/mL||Standard Deviation|Mean
2577950|NCT02433678|Other Pre-specified|Change in Hypertension Mediators|Plasma concentration measurement of Angitosensin II through enzyme-linked immunosorbent assay|12 weeks|Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm|||pg/mL||Standard Deviation|Mean
2577953|NCT02433678|Secondary|Changes in Expression of Inflammatory Mediators|Toll-like receptor 4 measurement in mononuclear cells through real time polymerase chain reaction|12 weeks|Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm|||arbitrary unit||Standard Deviation|Mean
2577954|NCT02433678|Secondary|Changes in Expression of Inflammatory Mediators|c-Jun N-terminal kinase 1 measurement in Mononuclear cells through real time polymerase chain reaction|12 weeks|Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm|||arbitrary unit||Standard Deviation|Mean
2577955|NCT02433678|Secondary|Changes in Expression of Inflammatory Mediators|Interleukin 1 Beta measurement in mononuclear cells through real time polymerase chain reaction|12 weeks|Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm|||arbitrary unit||Standard Deviation|Mean
2577956|NCT02433678|Secondary|Changes in Expression of Inflammatory Mediators|Suppressor Of Cytokine Signaling 3 measurement in Mononuclear cells through real time polymerase chain reaction|12 weeks|Out of the 26 patients in each group, 4 dropped in the placebo arm and 3 dropped in the drug arm|||arbitrary unit||Standard Deviation|Mean
2577957|NCT02433678|Secondary|Changes in Expression of Inflammatory Mediators|p47phox in mononuclear cells through real time polymerase chain reaction|12 Weeks|Out of the 26 total patients in each group, 4 dropped in the placebo arm and 3 dropped in the Dapagliflozin arm|||arbitrary unit||Standard Deviation|Mean
2577958|NCT02433678|Primary|Difference in the Percent Change in Fasting Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells Activation (DNA Binding Activity) in Mononuclear Cells Before and After Dapagliflozin Use|nuclear factor kappa-light-chain-enhancer of activated B cells measurement through Transcription factor assay|12 weeks|Out of the 26 total patients in each group, 4 dropped in the placebo arm and 3 dropped in the Dapagliflozin arm|||arbitrary unit||Standard Deviation|Mean
2577959|NCT02433496|Secondary|Average Morphine Equivalent Daily Dose (MEDD)|The average MEDD in milligrams for patients with consistent opioid Rx.|Up to 12 months|This is the number of patients who have a consistent opioid Rx.|||milligrams||Standard Deviation|Mean
2577960|NCT02433496|Secondary|Proportion With MEDD >120 mg|The proportion of patients who have consistent opioid Rx above a morphine equivalent daily dose about 120 mg.|Up to 12 months|This is the number of patients who have a consistent opioid Rx.|||Proportion of participants|||Number
2577961|NCT02433496|Secondary|Intervention Cost|Total cost of coaching intervention among all clinics that received physician coaching. At clinic level.|Up to 12 months|Four clinics were analyzed. No intervention was given to control group clinics, so there is no reported data.|||Dollars|clinics||Number
2577962|NCT02433496|Secondary|Intervention Fidelity|Total hours of coaching delivered/received among all clinics that received physician coaching.|Up to 12 months|Four clinics were analyzed for this measure. Since the intervention was specific to the physician coaching group, no time was spent in the Control group, thus there is no data to be reported.|||hours spent delivering implementation|clinics||Number
2577963|NCT02433496|Secondary|Participating Staff Characteristics|Characteristics of participating staff (profession)|Up to 12 months|These are clinic staff that made up the clinic change teams. Since change teams were specific to the physician coaching group, no change teams were constructed in the Control group, thus there is no data to be reported.|||Participants|||Count of Participants
2577964|NCT02433496|Secondary|Participating Clinic Characteristics|Characteristics of participating clinics vs. non-participating clinics (number of patients, number of providers, overall opioid prescribing rate)|Up to 12 months||||participants|||Number
2577965|NCT02433496|Secondary|Participating Patient Demographics|Characteristics of participating patients vs. general patient population (race, gender, ethnicity)|Up to 3 years||||percentage of patients|||Number
2577966|NCT02433496|Secondary|Provider Drop-out Rate|Number and percentage of providers who drop out of study at 3 months|3 months|This is at the prescriber level.|||Participants|||Count of Participants
2577967|NCT02433496|Secondary|High-dose Patients|Proportion of opioid prescriptions above 120 mg daily morphine equivalent|Up to 3 years|This is the number of patients who fall in the subset of consistent opioid use.|||Proportion of patients|||Number
2577968|NCT02433496|Secondary|Use of Pain Management Agreements|Proportion of opioid patients signing pain management agreements|Up to 3 years|This is the number of patients who fall in the subset of consistent opioid use.|||Proportion of patients|||Number
2577969|NCT02433496|Secondary|Mental Health Screening Rate|Proportion of opioid patients screened for mental health/substance use problems|Up to 3 years|This is the number of patients who fall in the subset of consistent opioid use.|||Proportion of patients|||Number
2577970|NCT02433496|Secondary|Urine Drug Screening Rate|Proportion of opioid patients completing urine drug screens prior to and during the study intervention|Up to 3 years|This is the number of patients who fall in the subset of consistent opioid use.|||Proportion of patients|||Number
2577971|NCT02433496|Secondary|Rate of Opioid / Benzodiazepine Co-prescribing|Proportion of patients with a chronic pain diagnosis receiving daily opioids and benzodiazepines concurrently.|Up to 3 years|This is the number of patients who fall in the subset of consistent opioid use.|||Proportion of patients|||Number
2577972|NCT02433496|Primary|Overall Rate of Opioid Prescribing|The proportion of patients with a chronic pain diagnosis receiving daily opioids.|Up to 3 years|This is the number of patients in each group.|||Proportion of patients|||Number
2577973|NCT02433483|Secondary|1-year Cumulative Incidence of Chronic Graft Versus Host Disease (GVHD)|All grades of GVHD will be reported.|From start of therapy through completion of therapy (approximately 1 year)|No patient survived long enough to evaluate chronic GVHD.||||||
2577974|NCT02433483|Other Pre-specified|Percent Donor Chimerism|Percent donor chimerism in blood and bone marrow.|At weeks 1, 2, 3, and 4 after infusion of HPC-A||||Percentage of donor chimerism||Full Range|Mean
2577975|NCT02433483|Secondary|1-year Cumulative Incidence of Acute Graft Versus Host Disease (GVHD)|"Children's Oncology Group (COG) Stem Cell Committee Consensus Guidelines for Establishing Organ Stage and Overall Grade of Acute Graft Versus Host Disease (GVHD) were used. Overall clinical grade was based on the highest stage obtained:~Grade 0: no stage 1-4 of any organ~Grade I: stage 1-2 skin and no liver or gut involvement~Grade II: stage 3 skin, or stage 1 liver involvement, or stage 1 GI~Grade III: stage 0-3 skin, with stage 2-3 liver, or stage 2-3 GI~Grade IV: stage 4 skin, liver or GI involvement"|From start of therapy through completion of therapy (approximately 1 year)||||Participants|||Count of Participants
2577976|NCT02433483|Secondary|Time to Platelet Recovery|"The time to platelet recovery will be summarized using descriptive statistics. If there are no deaths prior to recovery of platelets, nonparametric confidence intervals for the median time to recovery will be computed by inverting the sign test. Otherwise, we will compute cumulative incidence curves to describe the time to platelet and neutrophil recovery while adjusting for competing events.~Due to the small number of patients enrolled, the data is presented by patient."|From start of therapy to completion of therapy (approximately 1 year)|Platelet recovery for Patient #1 could not be determined due to transfusions.|||days|||Number
2577977|NCT02433483|Secondary|Median Time to Neutrophil Recovery|The time to neutrophil recovery will be summarized using descriptive statistics. If there are no deaths prior to recovery of neutrophils, nonparametric confidence intervals for the median time to recovery will be computed by inverting the sign test. Otherwise, we will compute cumulative incidence curves to describe the time to platelet and neutrophil recovery while adjusting for competing events.|From start of therapy to completion of therapy (approximately 1 year)||||Days||Full Range|Median
2577978|NCT02433483|Secondary|3-year Overall Survival (OS)|We will use the Kaplan-Meier method to describe overall survival. Overall survival will be defined as the time from enrollment to death, with living subjects' time censored at the date of last follow-up|3 years after enrollment of the last participant||||Percentage of participants|||Number
2577979|NCT02433483|Secondary|3-year Event Free Survival (EFS)|We will use the Kaplan-Meier method to describe event-free survival. EFS will be defined as the time from enrollment to death, relapse, or refractory disease with event-free subjects' time censored at the date of last follow-up.|3 years after enrollment of the last participant||||Percentage of participants|||Number
2577980|NCT02433483|Primary|Proportion of Participants Who Experience Therapeutic Success|"All patients will be counted towards this two-stage design. Therapeutic success for patients at time of enrollment is defined as:~Patients with fewer than 5% blasts, a ≥ 10-fold decrease in level of minimal residual disease after completion of 1 or 2 cycles of therapy.~Patients with greater than 5% in leukemic blasts in the marrow, achieving CR or CRi after completion of 1 or 2 cycles of therapy.~In terms of efficacy, patients who die before achieving therapeutic success will be counted as a failure, and all patients who receive ≥ 1 dose of protocol chemotherapy will be counted as a failure or success. Only subjects who withdraw or die prior to receiving the first dose of protocol chemotherapy will be considered inevaluable and replaced. The evaluation of tolerability and this phase II design will be performed concurrently, i.e., the first enrollees will be counted for both tolerability and efficacy."|At the end of therapy cycle 2 (approximately 2-3 months)||||proportion|||Number
2577981|NCT02433483|Primary|Number of Participants by Stratum Who Complete 2 Cycles of Therapy|If two or more patients die from causes other than leukemia progression or experience ≥ Grade 3 GVHD that is associated with detectable donor chimerism due to this protocol, or demonstrate persistent engraftment defined as >5% donor chimerism at the time of count recovery (ANC > 0.3 x 10^9/L and platelet count > 30 x 10^/L), then the cohort will close due to intolerability. Any subject who transfers to transplant prior to completion of two courses without experiencing an unacceptable toxicity is considered inevaluable for purposes of evaluating tolerability. Accrual will be halted for intolerability if there are two or more failures in tolerability among the first six subjects who are evaluable for tolerability.|At the end of therapy cycle 2 (approximately 2-3 months)||||Participants|||Count of Participants
2577982|NCT02433366|Primary|Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire)|The Outcome measure is summarized using the following categories; A: Patients who received the Patient Alert Card, read it and understood its content, B: Patients who completed the Patient Alert Card with the patient specific information, C: Patients who were well informed about their treatment and the actions to be taken in case of serious complications, D: Patents who knew about the anticoagulant effect of Pradaxa®, E: Patients who were well aware of the potential side effect-bruising, F: Patients who were well aware of the potential side effect-bleeding. This Outcome measure is applicable only for the Patients group.|Day 1|AF patients on treatment with Pradaxa®.|||Percentage of Participants|||Number
2577983|NCT02433366|Primary|Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire)|"The Outcome measure is summarized using the following categories; A: Physicians who spontaneously remembered the receipt of the Patient alert card, B: Physicians who spontaneously remembered the receipt of the Prescriber Guide, C: Physicians who were satisfied with the information provided in the Prescriber guide, D: Physicians who were aware of the importance of determining and controlling of the Patients renal function for correct pradaxa dosing.~This Outcome measure is applicable only for the Physicians group."|Day 1|Physicians who were current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF)|||Percentage of Participants|||Number
2577984|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 36|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578007|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 32|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2577985|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 32|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2577986|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 28|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2577987|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 24|Percentage of participants achieving CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2577988|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 20|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2577989|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 16|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2577990|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 12|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2577991|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 8|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578008|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 28|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2577992|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 6|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2577993|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 4|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2577994|NCT02433340|Secondary|CR Response Rate Per CDAI Criteria at Week 2|Percentage of participants achieving CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2577995|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 36|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2577996|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 32|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2577997|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 28|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2577998|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 24|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578009|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 24|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2577999|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 20|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578000|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 16|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578001|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 12|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578002|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 8|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578003|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 6|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578004|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 4|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578005|NCT02433340|Secondary|LDA or CR Response Rate Per CDAI at Week 2|Percentage of participants achieving LDA or CR per CDAI criteria. The CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA was defined as a score from 2.8 to ≤ 10; CR was defined as a score ≤ 2.8. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578006|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 36|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578010|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 20|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578011|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 16|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578012|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 12|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578013|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 8|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578014|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 6|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578015|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 4|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578016|NCT02433340|Secondary|CR Response Rate Per DAS28 (hsCRP) at Week 2|Percentage of participants achieving CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578017|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 36|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578059|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 4|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
2578018|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 32|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578019|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 28|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578020|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 24|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578021|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 20|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578022|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 16|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578023|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 12|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578024|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 8|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578025|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 6|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578210|NCT02432287|Primary|Increase in Number of Expressed Genes in Muscle and Adipose Tissue Using RNA Sequencing (RNA-Seq)|The investigators hypothesize that treatment with metformin will result in changes in the transcriptome. The investigators will test this by identifying increases in gene expression in muscle and adipose tissue with RNA Sequencing (RNA-Seq) in metformin and in placebo.|6 weeks||||genes|||Number
2578026|NCT02433340|Secondary|LDA or CR Response Rate Per DAS28 (hsCRP) at Week 4|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578027|NCT02433340|Secondary|Low Disease Activity (LDA) or Clinical Remission (CR) Response Rate Per DAS28 (hsCRP) at Week 2|Percentage of participants achieving LDA or CR on the DAS28 (hsCRP). The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 (no disease activity) to 10 (highest degree of disease activity). LDA was defined as a score from 2.6 to < 3.2, and CR was defined as a score < 2.6. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578028|NCT02433340|Secondary|Change From Baseline in CDAI at Week 36|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578029|NCT02433340|Secondary|Change From Baseline in CDAI at Week 32|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578030|NCT02433340|Secondary|Change From Baseline in CDAI at Week 28|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578031|NCT02433340|Secondary|Change From Baseline in CDAI at Week 24|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578032|NCT02433340|Secondary|Change From Baseline in CDAI at Week 20|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578033|NCT02433340|Secondary|Change From Baseline in CDAI at Week 16|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578034|NCT02433340|Secondary|Change From Baseline in CDAI at Week 12|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578035|NCT02433340|Secondary|Change From Baseline in CDAI at Week 8|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578036|NCT02433340|Secondary|Change From Baseline in CDAI at Week 6|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578037|NCT02433340|Secondary|Change From Baseline in CDAI at Week 4|CDAI is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578038|NCT02433340|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 2|CDAI is a composite index for assessing disease activity based on the summation of the counts of Tender Joint Count 28 (TJC28) and Swollen Joint Count 28 (SJC28), patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578039|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 36|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578040|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 32|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578041|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 28|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578042|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 24|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578043|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 20|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578044|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 16|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578045|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 12|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578046|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 8|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578047|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 6|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578048|NCT02433340|Secondary|Change From Baseline in DAS28 (hsCRP) at Week 4|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578049|NCT02433340|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 2|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578050|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 36|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
2578051|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 32|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
2578052|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 28|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
2578053|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 24|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
2578054|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 20|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
2578055|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 16|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
2578056|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 12|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
2578057|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 8|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
2578058|NCT02433340|Secondary|Change From Baseline in hsCRP at Week 6|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
2578060|NCT02433340|Secondary|Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP) at Week 2|For analysis purposes, all baseline are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||mg/L||Standard Deviation|Mean
2578061|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 36|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578062|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 32|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578063|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 28|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578064|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 24|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578065|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 20|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578066|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 16|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578067|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 12|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578068|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 8|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2580231|NCT02408445|Secondary|Change in Penile Length|Stretched penile length will be measured by a physician before randomization and at the end of the study period.|Baseline and 3 months||||cm||Standard Deviation|Mean
2578069|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 6|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578070|NCT02433340|Secondary|Change From Baseline in HAQ-DI at Week 4|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578071|NCT02433340|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 2|HAQ-DI is a self-reported participant outcome measurement. It is calculated as the mean of the scores from 8 following categories with a range 0 - 3: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. The higher the score, the more likely to associate with morbidity and mortality for the participant. The minimum clinically important difference in HAQ-DI was defined as change from baseline ≤ -0.22. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578072|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 36|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578073|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 32|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578074|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 28|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578075|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 24|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578076|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 20|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578077|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 16|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578078|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 12|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578079|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 8|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578080|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 6|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578081|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 4|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578082|NCT02433340|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Week 2|The physician assessed the participant's disease activity at the time of visit using a Physician's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578083|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 36|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578084|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 32|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578085|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 28|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578086|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 24|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578087|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 20|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578088|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 16|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578089|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 12|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578090|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 8|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578091|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 6|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578092|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 4|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578093|NCT02433340|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 2|Participants assessed their disease activity for the past 24 hours using a Patient's Global Assessment of Disease VAS. The range is 0 to 100 mm with no activity being indicated by 0 and severe activity by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578094|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 36|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578095|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 32|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578096|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 28|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578097|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 24|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578098|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 20|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578099|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 16|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578100|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 12|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578458|NCT02429583|Secondary|Frequency and Functional Status of Anti-HBsAg Antibody-producing B Cells Post-vaccination Doses Over Time|ELISPOT assays will measured at 8 months|8 months|The data was not collected and the analysis was not completed for this study due to insufficient enrollment.||||||
2578101|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 8|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578102|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 6|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578103|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 4|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain VAS. The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||units on a scale||Standard Deviation|Mean
2578104|NCT02433340|Secondary|Change From Baseline in Patient's Assessment of Pain at Week 2|Participants assessed their pain in the previous week using a Patient's Global Assessment Pain visual analogue scale (VAS). The range is 0 to 100 mm with no pain being indicated by 0 and severe pain by 100. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had a baseline and post-baseline assessment. LOCF was used for missing data; LOCF imputation was conducted separately for M12-963 and M12-965 (ie, data from M12-963 was not carried forward to visits in M12-965).|||units on a scale||Standard Deviation|Mean
2578105|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 36|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
2578106|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 32|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
2578107|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 28|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
2578108|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 24|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
2578109|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 20|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
2578110|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 16|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
2578111|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 12|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
2578112|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 8|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
2578113|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 6|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
2578114|NCT02433340|Secondary|Change From Baseline in SJC66 at Week 4|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
2578115|NCT02433340|Secondary|Change From Baseline in Swollen Joint Count (SJC66) at Week 2|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||swollen joints||Standard Deviation|Mean
2578116|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 36|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
2578132|NCT02433340|Primary|ACR70 Response Rate at Week 20|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2593117|NCT02249104|Secondary|Mean Change From Baseline in Inflammatory Lesion Count||Baseline and 8 weeks||||Lesions counted||Standard Deviation|Mean
2578117|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 32|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
2578118|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 28|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
2578119|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 24|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
2578120|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 20|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
2578121|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 16|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
2578122|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 12|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
2578123|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 8|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
2578133|NCT02433340|Primary|ACR70 Response Rate at Week 16|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578124|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 6|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
2578125|NCT02433340|Secondary|Change From Baseline in TJC68 at Week 4|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
2578126|NCT02433340|Secondary|Change From Baseline In Tender Joint Count (TJC68) at Week 2|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. For analysis purposes, all baseline values are defined as the last measurement on or before the first dose of study drug in Study M12-963."|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||tender joints||Standard Deviation|Mean
2578127|NCT02433340|Primary|Summary of Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation, and Deaths|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. An SAE is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.|from the first dose of study drug in study M12-965 until 70 days after the last dose of study drug (up to 32 weeks)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965.|||Participants|||Count of Participants
2578128|NCT02433340|Primary|ACR70 Response Rate at Week 36|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578129|NCT02433340|Primary|ACR70 Response Rate at Week 32|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578130|NCT02433340|Primary|ACR70 Response Rate at Week 28|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578131|NCT02433340|Primary|ACR70 Response Rate at Week 24|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578180|NCT02432729|Primary|8-epi-prostaglandin F2α (8-epi-PGF2α).|Concentrations of 8-epi-PGF2α measured in urine and expressed as concentration adjusted for creatinine. Geometric Means are provided as descriptive statistics.|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||pg/mg creat||95% Confidence Interval|Geometric Mean
2578134|NCT02433340|Primary|ACR70 Response Rate at Week 12|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578135|NCT02433340|Primary|ACR70 Response Rate at Week 8|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578136|NCT02433340|Primary|ACR70 Response Rate at Week 6|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578137|NCT02433340|Primary|ACR70 Response Rate at Week 4|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578138|NCT02433340|Primary|ACR70 Response Rate at Week 2|Percentage of participants with an ACR70 response, defined as at least 70% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578139|NCT02433340|Primary|ACR50 Response Rate at Week 36|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578140|NCT02433340|Primary|ACR50 Response Rate at Week 32|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578141|NCT02433340|Primary|ACR50 Response Rate at Week 28|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578142|NCT02433340|Primary|ACR50 Response Rate at Week 24|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578143|NCT02433340|Primary|ACR50 Response Rate at Week 20|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578144|NCT02433340|Primary|ACR50 Response Rate at Week 16|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578145|NCT02433340|Primary|ACR50 Response Rate at Week 12|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578146|NCT02433340|Primary|ACR50 Response Rate at Week 8|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578147|NCT02433340|Primary|ACR50 Response Rate at Week 6|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578148|NCT02433340|Primary|ACR50 Response Rate at Week 4|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578149|NCT02433340|Primary|ACR50 Response Rate at Week 2|Percentage of participants with an ACR50 response, defined as at least 50% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578150|NCT02433340|Primary|ACR20 Response Rate at Week 36|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 36 (Week 24 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578151|NCT02433340|Primary|ACR20 Response Rate at Week 32|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 32 (Week 20 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578152|NCT02433340|Primary|ACR20 Response Rate at Week 28|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 28 (Week 16 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578153|NCT02433340|Primary|ACR20 Response Rate at Week 24|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 24 (Week 12 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578154|NCT02433340|Primary|ACR20 Response Rate at Week 20|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 20 (Week 8 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578155|NCT02433340|Primary|ACR20 Response Rate at Week 16|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 16 (Week 4 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578156|NCT02433340|Primary|ACR20 Response Rate at Week 12|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 12 of Study M12-963 (considered Week 0 of Study M12-965)|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578157|NCT02433340|Primary|ACR20 Response Rate at Week 8|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 8 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578158|NCT02433340|Primary|ACR20 Response Rate at Week 6|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 6 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578159|NCT02433340|Primary|ACR20 Response Rate at Week 4|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in TJC68, SJC66, and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 4 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. LOCF was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578160|NCT02433340|Primary|American College of Rheumatology (ACR) 20 Response Rate at Week 2|Percentage of participants with an ACR20 response, defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agrestil-Coull method.|Week 2 of Study M12-963|Safety Analysis Set: all participants who received at least 1 dose of study medication in M12-965 and had an assessment. Last observation carried forward (LOCF) was used for missing data.|||percentage of participants||95% Confidence Interval|Number
2578161|NCT02433288|Secondary|Percent Change in Low-Density Lipoprotein-Cholesterol (LDL-C) From Baseline|Low-Density Lipoprotein-Cholesterol (LDL-C) change from baseline at the Week 24 assessment for subjects who completed 24 weeks of treatment|Baseline and Week 24|FAS|||% change||Standard Error|Mean
2578162|NCT02433288|Post-Hoc|Reported Treatment Adherence|The number of reported rosuvastatin tablets taken divided by the total number of days reported during the treatment. This is eliminated any missing data from the calculation.|Up to 24 weeks|FAS|||% adherence||Standard Deviation|Mean
2578163|NCT02433288|Secondary|Treatment Adherence|The number of reported rosuvastatin tablets taken divided by the total number of days in the study.|Up to 24 weeks|FAS|||% adherence||Standard Deviation|Mean
2578164|NCT02433288|Secondary|Percentage of Fully Adherent Patients|The number of patients who answered 'Yes' to Q4 of Rosuvastatin Adherence Questionnaire (RAQ) at all time points divided by the total number of randomized patients.|Up to 24 weeks|FAS|||% of patients|||Number
2578165|NCT02433288|Primary|Duration of Treatment|The time from randomization to last patient reported visit (prior to the end-of-study visit) to a doctor to get a prescription for rosuvastatin plus the number of days of medicine provided in that last prescription.|limited to 169 days|FAS|||days||Standard Error|Mean
2578166|NCT02432729|Primary|Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).|Concentrations of Total NNAL measured in urine and expressed as concentration adjusted for creatinine. Geometric means are provided as descriptive statistics.|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||pg/mg creat||95% Confidence Interval|Geometric Mean
2578167|NCT02432729|Primary|FEF 25-75 Forced Expiratory Flow, Post-bronchodilator, Expressed as Percentage Predicted (FEF 25-75 %Pred)|"Post-bronchodilator FEF 25-75, expressed as percentage predicted (FEF 25-75 %pred). Mean values are provided as descriptive statistics.~Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. The forced expiratory flow between 25% and 75% of the FVC (FEF25-75%) is defined as the forced expiratory flow during the middle half of the FVC; the average flow from the point at which 25% of the FVC has been exhaled to the point at which 75% of the FVC has been exhaled."|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||Percent of predicted FEF 25-75%||95% Confidence Interval|Mean
2578168|NCT02432729|Primary|FEF 25-75 Forced Expiratory Flow, Pre-bronchodilator, Expressed as Percentage Predicted (FEF 25-75 %Pred)|"Pre-bronchodilator FEF 25-75, expressed as percentage predicted (FEF 25-75 %pred). Mean values are provided as descriptive statistics.~Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. The forced expiratory flow between 25% and 75% of the FVC (FEF25-75%) is defined as the forced expiratory flow during the middle half of the FVC; the average flow from the point at which 25% of the FVC has been exhaled to the point at which 75% of the FVC has been exhaled."|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||Percent of predicted FEF 25-75%||95% Confidence Interval|Mean
2578169|NCT02432729|Primary|FEV1/FVC Post-bronchodilator Expressed as a Ratio|"Post-bronchodilator FEV1/FVC expressed as a ratio. Mean values are provided as descriptive statistics.~Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. The primary signal measured in spirometry may be volume or flow. The forced vital capacity (FVC) is the maximal volume of air exhaled with maximally forced effort from a maximal inspiration, and the forced expiratory volume (FEV) in one second is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration."|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||ratio||95% Confidence Interval|Mean
2578170|NCT02432729|Primary|FEV1/FVC Pre-bronchodilator Expressed as a Ratio|"Pre-bronchodilator FEV1/FVC expressed as a ratio. Mean values are provided as descriptive statistics.~Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. The primary signal measured in spirometry may be volume or flow. The forced vital capacity (FVC) is the maximal volume of air exhaled with maximally forced effort from a maximal inspiration, and the forced expiratory volume (FEV) in one second is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration."|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||ratio||95% Confidence Interval|Mean
2578171|NCT02432729|Primary|FVC Post-bronchodilator, Expressed as Percentage Predicted (FVC %Pred).|"Post-bronchodilator Forced Vital Capacity, expressed as percentage predicted (FVC %pred). Mean values are provided as descriptive statistics.~Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. The primary signal measured in spirometry may be volume or flow. The forced vital capacity (FVC) is the maximal volume of air exhaled with maximally forced effort from a maximal inspiration."|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||Percent of predicted FVC||95% Confidence Interval|Mean
2578172|NCT02432729|Primary|Forced Vital Capacity (FVC) Pre-bronchodilator, Expressed as Percentage Predicted (FVC %Pred).|"Pre-bronchodilator Forced Vital Capacity, expressed as percentage predicted (FVC %pred). Mean values are provided as descriptive statistics.~Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. The primary signal measured in spirometry may be volume or flow. The forced vital capacity (FVC) is the maximal volume of air exhaled with maximally forced effort from a maximal inspiration."|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||Percent of predicted FVC||95% Confidence Interval|Mean
2578173|NCT02432729|Primary|FEV1 Post-bronchodilator and Expressed as Percentage Predicted (FEV1 %Pred).|"FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred). Mean values are provided as descriptive statistics.~Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. The primary signal measured in spirometry may be volume or flow. The forced expiratory volume (FEV) in one second is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration."|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||Percent of predicted FEV1||95% Confidence Interval|Mean
2578174|NCT02432729|Primary|Forced Expiratory Volume in 1 Second (FEV1), Pre-bronchodilator and Expressed as Percentage Predicted (FEV1 %Pred).|"FEV1 pre-bronchodilator and expressed as percentage predicted (FEV1 %pred).~Mean values are provided as descriptive statistics.~Spirometry is a physiological test that measures how an individual inhales or exhales volumes of air as a function of time. The primary signal measured in spirometry may be volume or flow. The forced expiratory volume (FEV) in one second is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration."|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||Percent of predicted FEV1||95% Confidence Interval|Mean
2578175|NCT02432729|Primary|HbA1c|Glycosylated hemoglobin (HbA1c) is assayed from whole blood. Geometric means are provided as descriptive statistics.|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||percentage of glycated hemoglobin||95% Confidence Interval|Mean
2578176|NCT02432729|Primary|Carboxyhemoglobin (COHb).|Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Geometric means are provided as descriptive statistics.|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||percentage||95% Confidence Interval|Geometric Mean
2578177|NCT02432729|Primary|Albumin|Concentrations of Albumin measured in urine and expressed as concentration adjusted for creatinine. Geometric mean values are provided as descriptive statistics.|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||mg/g creat||95% Confidence Interval|Geometric Mean
2578178|NCT02432729|Primary|Soluble Intercellular Adhesion Molecule 1 (sICAM-1).|Concentrations of sICAM-1 measured in serum. Geometric mean values are provided as descriptive statistics.|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||ng/mL||95% Confidence Interval|Geometric Mean
2578179|NCT02432729|Primary|MPO|Concentrations of Myeloperoxidase measured in serum. Geometric mean values are provided as descriptive statistics.|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||μg/L||95% Confidence Interval|Geometric Mean
2578195|NCT02432716|Primary|Safety Measured by Adverse Events|Number of adverse and/or serious events|1 year||||Participants|||Count of Participants
2578181|NCT02432729|Primary|11-dehydrothromboxane B2 (11-DTXB2).|Concentrations measured in urine and expressed as concentration adjusted for creatinine. Geometric mean values are provided as descriptive statistics.|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||pg/mg creat||95% Confidence Interval|Geometric Mean
2578182|NCT02432729|Primary|Platelets|Concentrations of Platelets measured in plasma. Geometric mean values are provided as descriptive statistics.|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||GI/L||95% Confidence Interval|Geometric Mean
2578183|NCT02432729|Primary|Fibrinogen|Concentrations of Fibrinogen measured in plasma. Geometric mean values are provided as descriptive statistics.|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||mg/dL||95% Confidence Interval|Geometric Mean
2578184|NCT02432729|Primary|Homocysteine|Concentrations of Homocysteine measured in plasma. Geometric mean values are provided as descriptive statistics.|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||μmol/L||95% Confidence Interval|Geometric Mean
2578185|NCT02432729|Primary|Hs-CRP|Concentrations of high sensitivity C-reactive protein (hs-CRP) measured in serum. Geometric mean values are provided as descriptive statistics.|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||mg/L||95% Confidence Interval|Geometric Mean
2578186|NCT02432729|Primary|White Blood Cells (WBC).|Concentrations of WBC measured in blood. Mean values are provided as descriptive statistics.|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||GI/L||95% Confidence Interval|Mean
2578187|NCT02432729|Primary|Apo B|Concentrations of Apolipoprotein B measured in serum. Mean values are provided as descriptive statistics.|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||mg/dL||95% Confidence Interval|Mean
2578188|NCT02432729|Primary|Apo A1|Concentrations of Apolipoprotein A1 measured in serum. Mean values are provided as descriptive statistics.|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||mg/dL||95% Confidence Interval|Mean
2578189|NCT02432729|Primary|Low-density Lipoprotein Cholesterol (LDL-C)|Concentrations of LDL-C measured in serum. Mean values are provided as descriptive statistics.|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||mg/dL||95% Confidence Interval|Mean
2578190|NCT02432729|Primary|High Density Lipoprotein C (HDL-C).|Concentrations of HDL-C measured in serum. Mean values are provided as descriptive statistics.|Baseline; 6 month; 12 month|Some subjects were prematurely discontinued from the study. Non-compliance with smoking abstinence was the most frequently reported reason for premature discontinuation from the study.|||mg/dL||95% Confidence Interval|Mean
2578191|NCT02432716|Secondary|Memory Retention Measured by Rivermead Behavioral Memory Test (RBMT-C).|The RBMT-C provides an objective measure of everyday memory problems reported and observed in subjects with memory difficulties. The test is standardized for use with children ranging in age from 5 to 10 years. Here, we used it for evaluation of Down Syndrome subjects. The story recall subtests involves immediate free recall, cued recall, and delayed recall of short story material which is presented orally to subjects by the examiner. The RBMT-C is appealing for use in this population because the task is engaging, simple, and has been shown in other studies to be an effective measure of memory functions. Memory retention is the percentage of story elements recalled after a delay compared to right after the story is complete. Range: 0-100. A higher score means a better outcome.|20 minutes||||percentage of story elements recalled||Standard Error|Mean
2578192|NCT02432716|Secondary|Cognitive Change Measured by Rivermead Behavioral Memory Test (RBMT-C)|"The RBMT-C provides an objective measure of everyday memory problems reported and observed in subjects with memory difficulties. The test is standardized for use with children ranging in age from 5 to 10 years. Here, we used it for evaluation of Down Syndrome subjects. The story recall subtests involves immediate free recall, cued recall, and delayed recall of short story material which is presented orally to subjects by the examiner. The RBMT-C is appealing for use in this population because the task is engaging, simple, and has been shown in other studies to be an effective measure of memory functions. For all, a higher score means a better outcome.~Immediate Recall is the number of story elements recalled right after the story is complete. Range: 0-31~Delayed Recall is the number of story elements recalled after a delay. Range: 0-31"|20 minutes|Rivermead Memory Retention is missing for one subject at post-saline time.|||score on a scale||Standard Error|Mean
2578193|NCT02432716|Secondary|Memory Retention Measured by Fuld Object-Memory Evaluation (FOME)|Memory retention is the percentage of items correctly identify during the delayed recall trial compared storage trial 5. Range: 0-100 percent. A higher percentage indicates a better outcome.|20 minutes||||percentage of items correctly identified||Standard Error|Mean
2578194|NCT02432716|Secondary|Cognitive Change Measured by Fuld Object-Memory Evaluation (FOME)|"During the examination, a patient is presented with ten common objects they are asked to identify by touch. The test uses distraction to test recall. For all, a higher score indicates a better outcome.~Learning curve is the number of objects the difference in the number of items they are able to correctly identify from the greater of trials 4 or 5 compared to trial 1. Range: 0-10~Total immediate recall is the number of objects recalled over all of the trials. Range: 0-50~Total delayed recall is the number of objects recalled after 5 minutes. Range: 0-10~Recognition memory is the number of items correct from a multiple choice list of three when unable to correctly identify items from delayed recall. Range: 0-10~Retention estimate is the number of items recalled after 5 minutes or being reminded with multiple choice. Range: 0-10"|20 minutes||||score on a scale||Standard Error|Mean
2578196|NCT02432456|Secondary|Oral Morphine Equivalent (Narcotic Usage) in Severely Injured|This is an analysis of the narcotic utilization during the study. Oral Morphine Equivalents is a means of standardizing narcotic utilization given a multitude of different medications are utilized. Medications are standardized to units (milligrams) or oral morphine for a standardized comparison.|Total Index Hospitalization up to 365 days|A total of 45 participants were categorized as severely injured within the adult trial. A total of 24 participants were categorized as severely injured within the elderly trial.|||oral morphine equivalents||Full Range|Median
2578197|NCT02432456|Secondary|Hallucination|Hallucinations were documented and confirmed by the treating medical team.|Total Index Hospitalization up to 365 days|Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.|||Participants|||Count of Participants
2578198|NCT02432456|Secondary|Respiratory Failure|Respiratory failure within this trial was defined by the need for unanticipated intubation and/or transfer to ICU for respiratory support.|Total Index Hospitalization up to 365 days|Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.|||Participants|||Count of Participants
2578199|NCT02432456|Secondary|Regional Anesthesia Utilization|This is a measure of the Epidural Placement rates. Epidural placement was binary as in patient received or did not receive an epidural infusion catheter for supplemental pain management.|Total Index Hospitalization up to 365 days|Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.|||participants|||Number
2578200|NCT02432456|Secondary|Length of Stay|Total hospital length of stay in days up to 365 days.|Total Index Hospitalization up to 365 days|Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.|||days||Inter-Quartile Range|Median
2578201|NCT02432456|Secondary|Oral Morphine Equivalent (Narcotic Usage)|This is an analysis of the narcotic utilization during the study. Oral Morphine Equivalents is a means of standardizing narcotic utilization given a multitude of different medications are utilized. Medications are standardized to units (milligrams) or oral morphine for a standardized comparison.|24-48 hours post infusion|Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.|||oral morphine equivalents||Full Range|Median
2578202|NCT02432456|Secondary|Oral Morphine Equivalent (Narcotic Usage)|This is an analysis of the narcotic utilization during the study. Oral Morphine Equivalents is a means of standardizing narcotic utilization given a multitude of different medications are utilized. Medications are standardized to units (milligrams) or oral morphine for a standardized comparison.|12-24 hours post infusion|Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.|||oral morphine equivalents||Full Range|Median
2578203|NCT02432456|Secondary|Visual Analog Numeric Pain Score|Visual Analog Numeric Pain scores are reported as a single numeric score between 0 and 10. The more severe the pain the higher the number with 10 representing the most severe pain imaginable.|24-48 hours post infusion|Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.|||score on a scale||Standard Deviation|Mean
2578204|NCT02432456|Primary|Visual Analog Numeric Pain Score|Visual Analog Numeric Pain scores are reported as a single numeric score between 0 and 10. The more severe the pain the higher the number with 10 representing the most severe pain imaginable.|12-24 hours post infusion|Adult trial consisted of 91 participants. The elderly trial consisted of 59 participants.|||score on a scale||Standard Deviation|Mean
2578205|NCT02432300|Secondary|State Trait Anxiety Inventory (STAI)|The STAI is a self-report measure of state and trait anxiety (20 items each). The trait anxiety subscale was the variable of interest for this study. Higher scores indicate more trait or state anxiety. Scores for each scale range from 20-80, with higher scores indicating greater anxiety. The raw scores were converted into T scores using age and gender norms provided by the authors for the STAI. A score of 50 represents the mean. A difference of 10 from the mean indicates a difference of one standard deviation. Higher T scores were still indicative of higher anxiety. We reported T scores for trait anxiety.|Week 6||||units on a scale||Standard Deviation|Mean
2578206|NCT02432300|Secondary|Patient Health Questionnaire-9 (PHQ-9) as an Assessment of Depression|The PHQ-9 is a self-report questionnaire designed to assess depression through nine questions that come directly from the DSM-IV signs and symptoms of major depression. The 9 items describe problems associated with depression, and participants must rate how often they have been bothered by the problems in the last 2 weeks on a 0-3 scale. The scores are summed for a total depression score, ranging from 0-27, which higher scores indicating greater depression.|Week 6||||units on a scale||Standard Deviation|Mean
2578207|NCT02432300|Primary|Levels of Emotional Awareness Scale (LEAS)|The LEAS is comprised of ten hypothetical scenarios that are three or four sentences in length. Participants must respond how they think they would feel and how another person would feel in response to the hypothetical scenario. The more discrete emotions (e.g., bad vs sad) receive higher points, as well as blended emotions (e.g. sad and angry). There are 10 items on this measure. The minimum score for each item is 0 and the max score for each item is 5. The item scores are summed to calculate a total score. Thus, the total scores range from 0-50; 0=lowest awareness and 50=highest awareness. A computerized scoring system and parallel forms were used.|Week 6||||units on a scale||Standard Deviation|Mean
2578208|NCT02432300|Primary|Toronto Alexithymia Scale-20 (TAS-20)|This is a 20-item self-report questionnaire comprised of three sub-constructs (Difficulty Identifying feelings, Difficulty Describing Feelings, Externally-oriented Thinking). The full scale range is 20-100 (higher scores indicate higher alexithymia). Subscales are summed to compute a total score Scores between 52 and 60 indicate moderate alexithymia; scores 61 and higher indicate high alexithymia.|Week 6||||units on a scale||Standard Deviation|Mean
2578209|NCT02432287|Secondary|Mixed Meal Tolerance. Assessment of Insulin Sensitivity and Insulin Secretion (Using a Modification of the Matsuda Index)|Assessment of insulin sensitivity and insulin secretion. Insulin sensitivity will be estimated from insulin and glucose levels obtained following the standard meal challenge, using a modification of the Matsuda index, which has been widely used for non-invasive assessment of insulin sensitivity and shows good correlation (r=0.73) with results obtained from euglycemic hyperinsulinemic clamp studies. A higher Matsuda index indicates better insulin sensitivity. The insulin sensitivity index (ISI (comp) was calculated using the following equation (where g denotes glucose at various time points and i denotes insulin at various time points): ISI (comp)= 10000/ ((g0*i0* ((g0*15+ g30*30+ g60*30+ g90*30+ g120*30+ g180*30+ g240*15)/240))* ((i0*15+ i30*30+ i60*30+ i90*30*+ i120*30+ i180*30+ i240*15)/240))^0.5|6 weeks||||index||Standard Deviation|Mean
2578211|NCT02432196|Secondary|Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days|Subject's freedom from Serious Adverse Events at >30 days post-implant. Time to events were estimated by Kaplan-Meier method.|6 months, 12 months, 18 months, 24 months|This outcome is reported for subjects who received the Harpoon Medical Device where data is available.|||percentage of subjects|||Number
2578212|NCT02432196|Secondary|Subject's Severity of Mitral Regurgitation Over Time|"Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. The numbers on the scale are reflected as follows: 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak.~Higher numbers on the scale show a worsening outcome."|6 months, 12 months, 18 months, and 24 months|This outcome is reported for subjects who received the Harpoon Medical Device where data is available.|||Participants|||Count of Participants
2578213|NCT02432196|Primary|Subject's Serious Adverse Events (SAE) Through Discharge|Number of Participants experiencing a Serious Adverse Event (SAE) through time of Discharge.|Discharge, an average of 6 days post implant|This outcome is reported for subjects who received the Harpoon Medical Device where data is available.|||Participants|||Count of Participants
2578214|NCT02432196|Primary|Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 30 Days|Subject's freedom from Serious Adverse Events during the ePTFE implantation procedure and at 30 days follow-up. Time to events were estimated by Kaplan-Meier method.|Procedure and 30 days|This outcome is reported for subjects who received the Harpoon Medical Device where data is available.|||percentage of subjects|||Number
2578215|NCT02432196|Primary|Subject's Procedural Success During the First 30 Days|Procedural success was defined as the patient leaving the operating room with a successful implant of one or more ePTFE cords on the mitral valve and reduced mitral regurgitation from severe to </=moderate at the conclusion of the procedure and at 30 days post-procedure.|Procedure and 30 days|This outcome is reported for enrolled subjects where data is available.|||Participants|||Count of Participants
2578216|NCT02432144|Secondary|Percent Change From Baseline Over Time in Urinary Glycosaminoglycan (uGAG) Excretion (Liquid Chromatography-Tandem Mass Spectrometry, Dermatan Sulfate)|First morning void urine was evaluated for uGAG concentration and normalized to urinary creatinine concentration.|Baseline (prior to the first dose of study drug in UX003-CL301), Weeks 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144|Full Analysis Set: all enrolled participants who received at least one dose of investigational product in this study; participants with an assessment at given time point.|||percentage change in uGAG excretion||Standard Deviation|Mean
2578217|NCT02432144|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation|An adverse event (AE) is defined as any untoward medical occurrence, whether or not considered drug related. A serious AE is an AE that at any dose, results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect; or is an important medical event. AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), Grade 5 (death). TEAEs were defined as reported AEs with onset during the treatment.|From first dose of study drug until 30 days after the last dose of study drug. Mean duration of UX003 treatment was 100.5 weeks.|Full Analysis Set: all enrolled participants who received at least one dose of investigational product in this study.|||Participants|||Count of Participants
2578218|NCT02432105|Secondary|Time to Cessation of Otorrhea|Time (in days) to the cessation of otorrhea in the enrolled ear(s) was calculated as the number of days from the day of surgery to the absence of otorrhea (ie, no discharge) as reported by the parent/caregiver via the BID diary. Participants were considered a treatment failure if, at any time during the course of the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).|Up to Day 14|ITT analysis set|||days||95% Confidence Interval|Median
2578219|NCT02432105|Secondary|Percentage of Subjects With Microbiological Success at Day 14|Microbiological success was attained if all pretherapy bacteria were absent in the study ear for the Test-of-Cure (TOC) (Day 14) specimen. Participants were considered a treatment failure if, at any time during the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).|Day 14|This analysis population includes all ITT subjects who were culture-positive at Day 1 in at least 1 ear (Microbiological Intent-to-Treat (MITT) analysis set).|||percentage of participants|||Number
2578220|NCT02432105|Primary|Percentage of Subjects With Sustained Clinical Cure at Day 8|A sustained clinical cure was attained if otorrhea was absent in the study ear at Day 8 (EOT) per the Investigator assessment and continued to be absent through the end of the study. Participants were considered a treatment failure if, at any time during the study, an alternative therapy was initiated to treat the postsurgical infection. All participants with missing or indeterminate outcomes were considered a failure (same as baseline observation carried forward).|Day 8|ITT analysis set|||percentage of participants|||Number
2578221|NCT02432040|Secondary|Adverse Events||6 months||||participants|||Number
2578222|NCT02432040|Secondary|Mean Change in hsCRP Levels||6 months|Intention-to-treat analysis was done. Patients who completed the study were included since they were the only ones who had another hsCRP reading after baseline.|||nmol/L||Standard Deviation|Mean
2578223|NCT02432040|Secondary|Mean Change in Lipid Profile Levels||6 months|Intention-to-treat analysis was done. Patients who completed the study were included.|||mg/dL||Standard Deviation|Mean
2578224|NCT02432040|Secondary|Mean Change in Dermatology Life Quality Index (DLQI) Scores After 6 Months||6 months|The number of patients analyzed were the ones who completed the study. Intention-to-treat analysis was done.|||units on a scale||Standard Deviation|Mean
2578225|NCT02432040|Secondary|Percentage of Patients Achieving PASI-50 at the End of 3 Months|PASI-50 means at least a 50% reduction from baseline PASI score|3 months|Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.|||percentage of participants|||Number
2578226|NCT02432040|Secondary|Monthly Mean Changes in PASI Scores|PASI scores were measured monthly and mean changes from baseline for each month for the whole 6-month duration of the study recorded.|Monthly from baseline to 6 months|Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.|||units on a scale||Standard Deviation|Mean
2578227|NCT02432040|Primary|Percentage of Patients Achieving PASI-50 in Each Arm at the End of 6 Months|Percentage of patients in each arm who will achieve 50% reduction in PASI scores at the end of 6 months will be compared|6 months|Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.|||percentage of participants|||Number
2578228|NCT02432040|Primary|Mean Gross Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline to the End of 6 Months|Psoriasis Area and Severity Index involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 - none, 1 - slight, 2 - moderate, 3 - severe, and 4 - very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 - 0% involvement, 1 - <10%, 2 - 10-<30%, 3 - 30-<50%, 4 - 50-<70%, 5 - 70-<90%, 6 - 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis.|6 months|Intention-to-treat analysis was done. Patients with a baseline score and who had at least one reading after baseline were included.|||units on a scale||Standard Deviation|Mean
2578229|NCT02431793|Secondary|Pain Score|Pain scores through structured questions about use in the past 24 hours were collected from participants. Pain Score was assessed on a scale from 0 to 10, where higher numbers represent higher pain scores.|7-14 days after enrollment|The population for this analysis includes anyone who answered the pain score questions at T2 (7-14 days post enrollment). The reported results represent the mean pain score (0-10), adjusting for health literacy, income, race and physician inter-correlation.|||score on a scale||95% Confidence Interval|Least Squares Mean
2578230|NCT02431793|Secondary|Current Opioid Misuse Measure (COMM)|Select questions from the Current Opioid Misuse Measure (COMM) will be used to assess if patients are safely taking their prescription opioids.|7-14 days after enrollment|The population for this analysis includes anyone who answered select COMM questions at T2 (7-14 days post enrollment). The reported results represent those who safely took their opioid medications, adjusting for health literacy, income, race and physician inter-correlation.|||probability||95% Confidence Interval|Least Squares Mean
2578231|NCT02431793|Secondary|Proper Medication Use (Medication Diary)|Patients medication use will be assessed through a combination of a home medication diary (collected at 7-14 days post enrollment), pill count, and patient report of medication use.|10 day medication diary|The population for this analysis includes anyone who returned their medication diary with medication information filled out. The reported results represent the predicted probability of correctly using medication (without errors), adjusting for physician inter-correlation.|||probability||95% Confidence Interval|Least Squares Mean
2578232|NCT02431793|Secondary|Medication Knowledge|The identification of the medications purpose, side effects, risks, warnings and benefits will be assessed through a structured questionnaire. Patients will be asked about each of the above via structured, open-ended items. Additionally, select questions from the validated Patient Opioid Education Measure and patient satisfaction questions will be included. The Patient Knowledge Score was developed from these questions, with a score range of 0 to 10. A higher score on the scale represents better patient knowledge.|7-14 days after enrollment|The population for this analysis includes anyone who answered the knowledge questions at T2 (7-14 days post enrollment). The reported results represent the mean knowledge score (0-10), adjusting for health literacy, income, race and physician inter-correlation.|||score on a scale||95% Confidence Interval|Least Squares Mean
2578233|NCT02431793|Primary|Safe Medication Dosing (Prescription Understanding)|Patient's ability to demonstrate correctly dosing their prescription opioid-acetaminophen pain reliever will be assessed through a series of questions. Correct dosing will be scored for each medication as yes/no reflecting having demonstrated all of the following: proper dose (# of pills), appropriate spacing (hours between doses), and total daily dose (not exceeding recommended daily dose).|7-14 days after enrollment|The population for this analysis includes anyone who completed the demonstrated dosing task at T2 (7-14 days post enrollment). The reported results represent the predicted probability of correctly demonstrating dosing, adjusting for health literacy and physician inter-correlation.|||probability||95% Confidence Interval|Least Squares Mean
2578234|NCT02431754|Secondary|Percentage of Participants With PGI-I (Drug Attributes Questionnaire) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms Improvement|PGI-I (Drug Attributes Questionnaire [DRAQ]) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms.The DRAQ includes the following urinary symptoms: 1. Difficulty to void; 2. Frequent nighttime voiding; 3. Feeling of incomplete emptying; 4. Frequent daytime voiding; 5. Urinary urgency; 6. Taking a long time to urinate; 7. Need abdominal pressure to void; 8. Dribbling, leakage, and/or accidents. Each urinary symptom in the DRAQ will be evaluated by a participant using the PGI-I (discrete variables with seven categories) at the end of each treatment period, compared with how the symptom was before the participant's began taking medication in this study. The percentage of participants who reported a PGI-I (Drug Attributes Questionnaire) score of 1 to 3 are presented in the table below.|Week 8|All randomized participants who received at least one dose of study drug and had a baseline and post baseline PGI-I (DRAQ) measurement.|||percentage of participants|||Number
2578235|NCT02431754|Secondary|Percentage of Participants With Global Impression of Improvement (PGI-I)|"The PGI I is a participant rated instrument that measures the improvement or worsening of the subject's symptoms based on a 7 point scale. A score of 1 indicates that the subject feels his symptoms are very much better. A score of 4 indicates that the subjects feels no change in his symptoms and a score of 7 indicates that the subject feels his symptoms are very much worse. The percentage of participants who reported a PGI-I score of 1 to 3 are presented in the table below."|Week 8|All randomized participants who received at least one dose of study drug and had a baseline and post baseline PGI-I measurement.|||percentage of participants|||Number
2578250|NCT02431559|Secondary|Median Overall Survival (OS) as Estimated Using the Kaplan-Meier Method|All subjects are followed for survival every 3 months for up to 3 years following initiation of study treatment. OS is measured from the date of the first dose of study treatment to the date of death or last follow-up. Subjects lost to follow-up are censored on the date when they were last known to be alive.|Up to 3 years||2021-06-30|06/2021||||
2578236|NCT02431754|Secondary|Change From Baseline on the IPSS Quality of Life Score (IPSS QoL )|"IPSS QoL assess participant response to the following question: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. Response options are Delighted (0), Pleased (1); Mostly satisfied (2); mixed about equally satisfied and dissatisfied (3); Mostly dissatisfied (4); Unhappy (5); Terrible (6), with a total ranging from 0 to 6 with higher numerical score representing worse Quality of Life from BPH symptom."|Baseline, Week 8|All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement.|||units on a scale||Standard Deviation|Mean
2578237|NCT02431754|Secondary|Change From Baseline on the IPSS Voiding (Obstructive) Subscore|IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score ranging from 0 to 20. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, Week 8|All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement.|||units on a scale||Standard Deviation|Mean
2578238|NCT02431754|Secondary|Change From Baseline on the IPSS Storage (Irritative) Subscore|IPSS Storage (Irritative) subscore was the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore ranging from 0 to 15. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline,Week 8|All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement.|||units on a scale||Standard Deviation|Mean
2578239|NCT02431754|Secondary|Change From Baseline on the International Prostate Symptom Score (IPSS) Total Score|IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.|Baseline, Week 8|All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement.|||units on a scale||Standard Deviation|Mean
2578240|NCT02431754|Primary|Percentage of Participants Preferring Combination Therapy Over Alpha Blocker Alone on the Treatment Preference Questionnaire (TPQ)|TPQ was used to investigate participant's preference between alpha1 blocker monotherapy and combination therapy with alpha1 blocker plus tadalafil. At the end of Treatment Period 2 (or discontinuation), participants were asked to choose a preferred treatment between the two treatments given in Treatment Period 1 and Treatment Period 2.|Week 20|All randomized participants who received at least one dose of study drug and completed the TPQ.|||percentage of participants|||Number
2578241|NCT02431741|Primary|Infection in the Wound (Signs of Clinical Infection)|Weekly Visual inspection of the wounds by the investigators.|weekly, for 5 weeks|ITT population|||participants|||Number
2578242|NCT02431598|Secondary|Severity of Motion Artifacts at Arterial Phase Imaging, Measured on a 1-5 Scale|"no motion artifact~minimal motion artifact~moderate motion artifact~severe motion artifact~extensive motion artifact"|following contrast administration, up to 5 minutes||||scores on a scale||Full Range|Mean
2578243|NCT02431598|Secondary|Percentage of Participants With Transient Severe Motion (TSM) Based on Presence of Motion Artifacts at Arterial Phase Imaging|Arterial-phase breath-holding duration and motion artifacts after each agent were compared using the Mann-Whitney-U test and the McNemar test.|following contrast administration, up to 5 minutes||||percentage of participants with TSM|||Number
2578244|NCT02431598|Secondary|Heart Rate Following Contrast Injection|Heart rate following contrast injection|following contrast administration, up to 5 minutes||||beats per minute||Standard Deviation|Mean
2578245|NCT02431598|Secondary|O2 Saturation Following Contrast Administration||following contrast administration, up to 5 minutes||||percentage||Standard Deviation|Mean
2578246|NCT02431598|Primary|Subject-reported Dyspnea, as Measured by Questionnaire Responses|After each breath-hold, the MRI technologist asked the volunteer through the scanner microphone the following two questions, with responses based on a 5-point scale: A) How difficult was it to hold your breath? (1-Not at all; 5-Very difficult); B) Do you feel short of breath now? (1-Not at all; 5-Very short of breath). Responses were recorded for each breath-hold.|following contrast administration, up to 5 minutes||||units on a scale (1-5)||Standard Deviation|Mean
2578247|NCT02431598|Primary|Subject Breath Hold Capacity, as Measured by Number of Seconds a Subject Can Hold His/Her Breath||following contrast administration, up to 5 minutes|All participants received all three drugs.|||seconds||Full Range|Median
2578248|NCT02431572|Primary|Median PBR Uptake|The median PBR28 uptake as measured by positron emission tomography (PET) following chemo-radiation. The 18-kDa translocator protein (TSPO) is a protein that is expressed in mitochondria and is particularly prominently expressed by activated microglia, infiltrating macrophages, and reactive astrocytes. Thus, it is a marker of neuro-inflammation. PBR28 is a second generation PET tracer that binds to TPSO. PBR28 uptake was quantified using the standardized uptake value (SUV), which is the ratio of activity per unit volume of the region of interest (ROI) compared to cerebellum. Higher values indicate increased uptake in the ROI.|At the time of suspected pseudo-progression (up to 4 weeks after consent)||||Ratio||Full Range|Median
2578249|NCT02431572|Primary|Change in PBR Uptake (Changes in PBR Uptake by PET)|The change in PBR uptake in arms cohorts A and B from baseline to the start of cycle 4 for metastatic melanoma patients or cycle 3 for glioblastoma patients. The 18-kDa translocator protein (TSPO) is a protein that is expressed in mitochondria and is particularly prominently expressed by activated microglia, infiltrating macrophages, and reactive astrocytes. Thus, it is a marker of neuro-inflammation. PBR28 is a second generation PET tracer that binds to TPSO. PBR28 uptake was quantified using the standardized uptake value (SUV), which is the ratio of activity per unit volume of the region of interest (ROI) compared to cerebellum. Higher values indicate increased uptake in the ROI.|At baseline and 3 to 4 months post baseline|Only a baseline measurement was taken for the 1 patient in cohort A. Change in PBR was therefore not possible to calculate for that patient. PBR PET was only assessed once in cohort C and is reported separately.|||percent change from baseline||Full Range|Median
2579241|NCT02418026|Secondary|Wellbeing Measured Using a Comfort Scale|"The comfort scale is a numeric rating scale ranging from 0 to 10 : 0 corresponds to no comfort and 10 corresponds to most comfortable."|Day 3||||units on a scale||Standard Deviation|Mean
2578251|NCT02431559|Secondary|Median PFS by irRECIST as Estimated Using the Kaplan-Meier Method|PFS is measured from the date of the first dose of study treatment to the date of earliest disease progression according to irRECIST or to the date of death, if disease progression does not occur. Per irRECIST, irPD is defined as a ≥ 20% increase from nadir in the TMTB (Bohnsack et al 2014).|Up to 15 months||2021-06-30|06/2021||||
2578252|NCT02431559|Secondary|PFS-12 by irRECIST as Estimated Using the Kaplan-Meier Method|PFS is measured from the date of the first dose of study treatment to the date of earliest disease progression according to irRECIST or to the date of death, if disease progression does not occur. Per irRECIST, irPD is defined as a ≥ 20% increase from nadir in the TMTB (Bohnsack et al 2014).|Up to 15 months||2021-06-30|06/2021||||
2578253|NCT02431559|Secondary|PFS-6 by irRECIST as Estimated Using the Kaplan-Meier Method|PFS is measured from the date of the first dose of study treatment to the date of earliest disease progression according to irRECIST or to the date of death, if disease progression does not occur. Per irRECIST, irPD is defined as a ≥ 20% increase from nadir in the TMTB (Bohnsack et al 2014).|Up to 15 months||2021-06-30|06/2021||||
2578254|NCT02431559|Secondary|Number of Subjects With Best Overall Tumor Response by the Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)|Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 14 days before the first dose of study treatment), every 3 cycles during study treatment, and during on-study follow-up approximately 3 months after the last disease assessment. Per irRECIST, measurable lesions are categorized as follows: irCR: Complete disappearance of all target lesions; irPR: ≥ 30% decrease from baseline in the total measurable tumor burden (TMTB); irPD: ≥ 20% increase from nadir in TMTB; irSD: not meeting above criteria (Bohnsack et al 2014).|Up to 15 months||2021-06-30|06/2021||||
2578255|NCT02431559|Secondary|PFS-12 by RECIST 1.1 as Estimated Using the Kaplan-Meier Method|PFS is measured from the date of the first dose of study treatment to the date of earliest disease progression according to RECIST 1.1 or to the date of death, if disease progression does not occur. Per RECIST 1.1, PD is defined as a ≥ 20% increase in the sum of the longest diameter of target lesions (Eisenhauer et al 2009).|Up to 15 months||2021-06-30|06/2021||||
2578256|NCT02431559|Secondary|Median PFS by RECIST 1.1 as Estimated Using the Kaplan-Meier Method|PFS is measured from the date of the first dose of study treatment to the date of earliest disease progression according to RECIST 1.1 or to the date of death, if disease progression does not occur. Per RECIST 1.1, PD is defined as a ≥ 20% increase in the sum of the longest diameter of target lesions (Eisenhauer et al 2009).|Up to 15 months|The population comprises all subjects who received at least one dose of study treatment.|||months||Full Range|Median
2578257|NCT02431559|Secondary|Number of Subjects With Best Overall Tumor Response by RECIST 1.1|Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 14 days before the first dose of study treatment), every 3 cycles during study treatment, and during on-study follow-up approximately 3 months after the last disease assessment. Per RECIST 1.1, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria (Eisenhauer et al 2009).|Up to 15 months|The population comprises all subjects who received at least one dose of study treatment.|||Participants|||Count of Participants
2578258|NCT02431559|Primary|Progression-free Survival Rate at 6 Months (PFS-6) by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Estimated Using the Kaplan-Meier Method|PFS-6 according to RECIST 1.1 is the primary endpoint in Phase 2 and a secondary endpoint in Phase 1, where PFS is measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression does not occur. Per RECIST 1.1, progressive disease (PD) is defined as a ≥ 20% increase in the sum of the longest diameter of target lesions (Eisenhauer et al 2009).|Up to 6 months for each patient|The population comprises all subjects who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2578259|NCT02431559|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs)|The primary endpoint in Phase 1 and a secondary endpoint in Phase 2 is the safety/tolerability of study treatment. Toxicity is graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) are reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent is signed through 90 days after the last dose of study treatment. Treatment-emergent AEs are those that occurred or worsened after administration of the first dose of study treatment.|Up to 15 months|The population comprises all subjects who received at least one dose of study treatment.|||Participants|||Count of Participants
2578260|NCT02431533|Post-Hoc|Unplanned Analysis- Participants With 30% or Greater Reduction in Stool Frequency/Day|Percentage of participants with a greater than 30% reduction in the number of stools/day.|Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-91)|The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome.|||percentage of participants||95% Confidence Interval|Number
2578261|NCT02431533|Post-Hoc|Participants With 30% or More Reduction in Functional Bowel Disease Severity Index (FBDSI)|"Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in FBDSI score between baseline and week 12 between the two groups.~A higher mean value indicates a greater reduction in bowel disease severity, better outcome.~Functional Bowel Disease Severity Index was the scale used to determine this outcome. The range on this scale is from 0-500, with 500 indicating the most severe functional bowel disease.~This measure represents the total number of participants that had a 30% or greater reduction in FBDSI score."|Baseline assessment compared to visit 5 assessment|The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome.|||Participants|||Count of Participants
2578348|NCT02430870|Secondary|AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2578262|NCT02431533|Secondary|FBDSI (Functional Bowel Disease Severity Index)|"Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in FBDSI score between baseline and week 12 between the two groups.~A higher mean value indicates a greater reduction in bowel disease severity, better outcome.~Functional Bowel Disease Severity Index was the scale used to determine this outcome. The range on this scale is from 0-500, with 500 indicating the most severe functional bowel disease.~Placebo group- Min: -10.00 Max: 350.00~Treatment group- Min: 0 Max: 300.00"|Baseline compared to Week 12||||units on a scale||95% Confidence Interval|Mean
2578263|NCT02431533|Secondary|Upper Gastrointestinal Symptom of Nausea|"Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in nausea between baseline and week 12 between the two groups.~A higher mean value indicates a greater reduction in nausea, better outcome.~Analog Scale from 0-4 was used by participants to rate upper GI symptoms of nausea(0= none, 4= incapacitating).~Placebo group- Min: 0.00 Max: 2.00~Treatment group- Min: -1.00 Max: 1.00"|Baseline and Week 12||||units on a scale||95% Confidence Interval|Mean
2578264|NCT02431533|Secondary|Upper Gastrointestinal Symptoms of Prolonged Digestion|"Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in prolonged digestion between baseline and week 12 between the two groups.~A higher mean value indicates a greater reduction in prolonged digestion, better outcome.~Analog Scale from 0-4 was used by participants to rate upper GI symptoms of prolonged digestion (0= none, 4= incapacitating).~Placebo group- Min: -2.00 Max: 1.00~Treatment group- Min: -1.00 Max: 3.00"|Baseline compared to Week 12||||units on a scale||95% Confidence Interval|Mean
2578265|NCT02431533|Secondary|The Difference in Change of Postprandial Fullness Severity|"Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Mean change in postprandial fullness between baseline and week 12 between the two groups.~A higher mean value indicates a greater reduction in a postprandial fullness, better outcome.~Analog Scale from 0-4 was used by participants to rate upper GI symptoms of postprandial fullness (0= no postprandial fullness, 4= incapacitating postprandial fullness).~Placebo group- Min: -1.00 Max: 2.00~Treatment group- Min: -1.00 Max: 2.00"|Baseline compared to Week 12||||units on a scale||95% Confidence Interval|Mean
2578266|NCT02431533|Secondary|Differences in Upper Gastrointestinal Symptoms- Early Satiety|"Differences Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period. Change in rate of early satiety on a scale from 0-4 (higher the score, the worse the outcome) Mean change in early satiety between baseline and week 12 between the two groups.~A higher mean value indicates a greater reduction in early satiety, better outcome.~Analog Scale from 0-4 was used by participants to rate upper GI symptoms of early satiety (0= none, 4= incapacitating).~Placebo group- Min: -2.00 Max: 1.00~Treatment group- Min: -2.00 Max: 2.00"|Baseline compared to Week 12||||units on a scale||95% Confidence Interval|Mean
2578267|NCT02431533|Secondary|Differences in Stool Frequency Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.|Number of stools/day|Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92)|The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome.|||stools/day||95% Confidence Interval|Mean
2578268|NCT02431533|Secondary|Differences in Stool Consistency Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.|"The stool consistency before and after the treatment was compared, the average for the first 2 run-in weeks (day 1 - day 14) and the last 2 weeks (day 78 - day 91) was calculated. A higher mean outcome indicates a greater reduction in loose stool/diarrhea (better outcome).~Bristol Stool Chart (1=severe constipation to 7 =severe diarrhea) was the scale used for measurement. The participant reported outcomes were averaged at above time points for comparison.~Min for placebo group: -.70 Max for treatment group: 2.57 Max for placebo group: 1.88~The total number of participants analyzed in each group differs as a result of the number of participants that either withdrew or were withdrawn in the study. Data were analyzed and compared for participants that completed the study."|Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92)|The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome.|||units on a scale||95% Confidence Interval|Mean
2578269|NCT02431533|Secondary|Differences in Abdominal Pain/Discomfort Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.|"Outcome measure is the mean change of abdominal pain, on a scale of 0-4 (0= no pain, 4= incapacitating pain), between baseline and Weeks 10 and 11. A larger change in average abdominal pain indicates a greater reduction in mean abdominal pain score, better outcome.~Min=-.067 for treatment group Min= -.99 for placebo group Max= 1.14 for treatment group Max= 1.63 for placebo group The total number of participants analyzed in each group differs as a result of the number of participants that either withdrew or were withdrawn in the study. Data were analyzed and compared for participants that completed the study."|Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-92)|The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome.|||units on a scale||95% Confidence Interval|Mean
2578270|NCT02431533|Secondary|Changes in the Patient's Assessment of Their Quality of Life Using Short Form(SF)-36 Health Survey PCS (Physical Component Score)|"Differences in quality of life phusical component score using SF-36 between the 'intervention' group and the 'placebo' group over the study period. Baseline PCS scores were compared to the end of the study time point. The mean difference between the 2 time points was measured.~The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. Scoring is based on software program.~Placebo group- Min: -16.16 Max: 6.25~Treatment group- Min: -16.42 Max: 5.46~The total number of participants analyzed in each group differs as a result of the number of participants that either withdrew or were withdrawn in the study. Data were analyzed and compared for participants that completed the study."|Baseline compared to Week 12 (end of study)|The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome.|||units on a scale||95% Confidence Interval|Mean
2578271|NCT02431533|Secondary|Differences in Upper Gastrointestinal Symptoms- Vomiting Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.|"vomit scale used was from 0-4, the higher the number, the worse the outcome Mean change in vomiting between baseline and week 12 between the two groups. A higher mean value indicates a greater reduction in vomiting, better outcome.~Analog Scale from 0-4 was used by participants to rate upper GI symptoms of vomiting(0= none, 4= incapacitating).~Placebo group- Min: 0 Max: 0~Treatment group- Min: -3.00 Max: 0"|Baseline compared to Week 12||||units on a scale||95% Confidence Interval|Mean
2578272|NCT02431533|Secondary|Differences in Upper Gastrointestinal Symptoms Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.|"Mean change in heartburn between baseline (days 1-14) and weeks 10 and 11 (days 78-91) between the two groups.~A higher mean value indicates a greater reduction in heartburn, better outcome.~Analog Scale from 0-4 was used by participants to rate upper GI symptoms of heartburn (0= no heartburn, 4= incapacitating).~Placebo group- Min: -2.00 Max: 3.00~Treatment group- Min: -2.00 Max: 2.00"|Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-91)||||units on a scale||95% Confidence Interval|Mean
2578273|NCT02431533|Primary|Change in the Bowel Movements (Stool Frequency) Between the 'Intervention' Group and the 'Placebo' Group Over the Study Period.|"For each patient stool frequency was measured as a number of bowel movements per day. To compare stool frequency before and after the treatment, the average for the first 2 run-in weeks (day 1 - day 14) and the last 2 weeks (day 78 - day 91) was calculated.~A higher mean score indicates a better outcome, a greater reduction in bowel movements/day and is a positive change.~Placebo group- min: -.43 max: 1.43~Study group- min: -.43 max: 1.50"|Baseline (days 1-14) compared to Weeks 10 and 11 of treatment (days 78-91)|The total number of participants analyzed for Di-Calcium Phosphate differs from the overall analysis number as the data for one of these participants was not sufficient for use (not enough data available to evaluate) for this particular outcome.|||bowel movements/day||95% Confidence Interval|Mean
2578274|NCT02431494|Secondary|Change of Self-esteem Score Over the Course of 9 Weeks|"Self-esteem will be assessed using the Rosenberg Self-Esteem Scale, one of the most widely-used self-esteem measures in social science research. It consists of ten items designed to assess respondent's self-satisfaction, self-respect and other general feelings about himself/herself. The response format is a four point Likert scale ranging from strongly agree to strongly disagree. For items 1, 2, 4, 6, 7: Strongly Agree=3, Agree=2, Disagree=1, and Strongly Disagree=0. For items 3, 5, 8, 9, 10: Strongly Agree=0, Agree=1, Disagree=2, and Strongly Disagree=3. The scale ranges from 0-30, higher scores indicating higher self-esteem."|Weeks 1 and 9|The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2578275|NCT02431494|Secondary|Change in Depressive Symptomatology Score Over the Course of 9 Weeks|"The investigators will assess depressive symptomatology using the Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith 1983), one of the most widely used screening tools to identify symptoms of depression, anxiety and emotional distress amongst patients being treated for a variety of clinical problems. It consists of 14 items, 7 of which assess generalized symptoms of anxiety and the remaining 7 assess depressive symptomatology. Although the specific wording of the item responses vary in accordance to the item, all responses are coded using a Likert format ranging from 0 to 3 where the most positive response is coded a 0 and the most negative response a 3. The maximum score for each subscale is 21; higher scores are reflective of more symptoms of anxiety or depression."|Weeks 1 and 9|The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2578276|NCT02431494|Secondary|Change in Social Anxiety Score Over the Course of 9 Weeks|"Symptoms of social anxiety will be assessed using the Liebowitz Social Anxiety Scale (Liebowitz, 1987), one of the most widely used scales to measure social anxiety. It consists of 24 items designed to assess fear and avoidance in different situations that are likely to produce social anxiety such as going to a party or speaking in public. For each situation, participants are first asked to state how fearful or anxious they feel in that situation using a Likert scale that ranges from none (0) to severe (3). Then they are asked to state how often they avoid that same situation using a Likert scale that ranges from never (0) to usually (3). Responses are summed to create an overall anxiety score."|Weeks 1 and 9|The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2578277|NCT02431494|Primary|Change in Dermatologic Quality of Life Over the Course of 9 Weeks|"The investigators will use the Dermatology Life Quality Index (DLQI) developed by A. Y. Finlay and G. K. Khan (1992), one of the most widely used, dermatologic specific quality of life measures in the published literature to assess quality of life. The DLQI consists of 10 Likert type items; 9 of these items have 4 response categories scored from 0 to 3 with very much being 3 to not at all being 0. Item 7 Over the last week, has participant's skin prevented participant from working or studying uses dichotomous responses; where yes is scored as a 3 and a no requires answering an additional sub-question, Over the past week how much has participant's skin been a problem at work or studying. Responses for this sub-question range from a lot coded a 2, to not at all coded a 0. The DLQI is calculated by summing the response to each question; the maximum score is 30 and the minimum score is 0. The higher the score, the lower the dermatologic quality of life."|Weeks 1,3,5,6,9|The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2578278|NCT02431494|Primary|Change in Acne Severity Over the Course of 9 Weeks|The investigators will use the acne counts and the digital photographs of the affected areas to compute the acne severity level following the procedures established by Hayashi et al. (2008). The investigators will not print the digital photographs. The investigators will visually inspect the digital photographs and assign a preliminary severity score to each half of the face using the following classification guide: 0-5 papules and/pustules for mild acne; 6-20 for moderate acne, 21-50 for severe acne; and more than 50 for very severe. The investigators will examine each half of the face separately. The most severe classification obtained for either side of the face will be the assigned severity score.|Weeks 1 and 9|The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2581793|NCT02388880|Primary|Cerebral Perfusion Pressure (CPP)|Change from baseline CPP compared with the CPP during use of the ITPR.|During 240 minutes of device use||||mmHg||Standard Deviation|Mean
2578279|NCT02431494|Primary|Change in the Amount of Sebum Produced Over the Course of 9 Weeks|The investigators will use the Sebumeter® SM 815 manufactured by CK Electronic to estimate the amount of sebum. The measurement is based on grease spot photometry. The mat tape of the Sebumeter® SM 815 is brought into contact with facial skin. It becomes transparent in relation to the sebum on the surface of the measurement area. Then the tape is inserted into the aperture of the device and the transparency is measured by a photocell. The light transmission represents the sebum content.|Weeks 1,3,5,6,9|The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2578280|NCT02431494|Primary|Change in Number of Acne Lesions Over the Course of 9 Weeks|The investigators will conduct a systematic count of acne lesions (papules and pustules) present in all of the affected areas of the face.|Weeks 1,3,5,6,9|The study was terminated and the PI has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2578281|NCT02431468|Post-Hoc|Severe Impairment Battery (SIB) Scores by Memantine Use at Baseline|Change from baseline in SIB score was compared between subjects receiving concurrent treatment with memantine and subjects not being treated with memantine.|Assessments at weeks 5, 9, 13, and 30 days after end of treatment (up to day 107).|Participants in the 3 treatment groups were further sorted by use of memantine. The number of participants in each category at each timepoint is noted. Attrition occurred through the course of the study.|||mean change from baseline in SIB score||Standard Deviation|Mean
2578282|NCT02431468|Secondary|Secondary Efficacy Endpoints|"Change from baseline in the Severe Impairment Battery (SIB) at Weeks 5 and 9. Assesses cognition. Score range 0-100. Lower scores indicate greater cognitive impairment.~Change from baseline in Alzheimer Disease Cooperative Study Activities of Daily Living Inventory-Severe Impairment Version (ADCS-ADL-SEV) at Weeks 5, 9,13. A 19-item test of the performance of activities of daily living. Total score range 0-54; lower scores indicate greater functional impairment.~Change from baseline in MMSE-2 at Weeks 5, 9 and 13. Tests selected aspects of cognition on a scale of 0-30. Lower scores indicate greater cognitive impairment.~Change from baseline in Neuropsychiatric Inventory (NPI) at Weeks 5, 9,13. Caregiver interview assesses 12 behavioral disturbances. Scores range from 0-144; higher scores indicate greater behavioral disturbances.~Clinical Global Impression of Improvement (CGI-I) at Weeks 5, 9, 13. A 7-point scale range from (1) very much improved to (7) very much worse."|Week 5, Week 9, Week 13|The number of participants analyzed over the course of the study diminished as a result of attrition.|||mean change from baseline||Standard Deviation|Mean
2578283|NCT02431468|Primary|Efficacy: Change From Baseline in Severe Impairment Battery (SIB) in the Full Analysis Set (FAS)|The primary statistical objective for efficacy was to estimate the effect of bryostatin on the mean change in the total SIB score after 12 weeks of treatment, assessed at Week 13 (day 91). Efficacy analyses were conducted according to randomized groups. The SIB is used to assess cognition in subjects with moderate and severe AD. It is divided into nine subscales that include attention, language, orientation, memory, praxis, visuospatial ability, construction, social skills, orienting head to name. Non-verbal responses are allowed, thus decreasing the need for language output. Forty questions are included with a point score range of 0-100. Lower scores indicate greater cognitive impairment.|Primary analysis at Week 13 (day 91) after 12 weeks of treatment (up to day 107)|The Full Analysis Set (FAS), consistent with a modified intention-to-treat principle (mITT), was defined as all randomized subjects who received at least one dose of randomized trial medication and who had at least one post-baseline assessment.|||mean change from baseline in SIB score||Standard Deviation|Mean
2578284|NCT02431468|Primary|Safety: Number of Subjects With Treatment-emergent Adverse Events and Serious Adverse Events|Evaluations of adverse events (AEs), serious adverse events (SAEs), Adverse event of special interest - myalgia|Baseline through 30 days post end of treatment (up to Day 107)|Safety Analysis Set|||participants|||Number
2578285|NCT02431455|Secondary|Postoperative Respiratory Complication|atelectasis found on chest imaging, pneumonia, or re intubation|entire inpatient say, usually 1 to 7 days||||participants|||Number
2578286|NCT02431455|Primary|Hypoxia 24 Hours Postoperative|Number of subjects with pulse oximetry reading of < 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 24 hours postoperative.|24 hours postoperative||||participants|||Number
2578287|NCT02431455|Primary|Hypoxia 12 Hours Postoperative|Number of subjects with pulse oximetry reading of < 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 12 hours postoperative.|12 hours postoperative||||participants|||Number
2578288|NCT02431455|Primary|Hypoxia 6 Hours Postoperative|Number of subjects with pulse oximetry reading of < 92% with subject off of supplemental oxygen for 5 minutes with head of bed at 30°, 6 hours postoperative.|6 hours postoperative||||participants|||Number
2578289|NCT02431299|Secondary|Brief COPE Maladaptive Subscale|This is a consumer rated assessment of adaptive coping skills. This is derived from the 28 item, full scale. The scale uses a 1-4 Likert scale, indicating the frequency of using different coping strategies. There are 14 subscales, each calculated by summing 2 items. The range on each subscale is 2 - 8. The 14 subscales are further combined into 2 larger scales - maladaptive and adaptive coping. Maladaptive coping is calculated by averaging the responses from 6 out of the 14 subscales. Higher scores indicate worse outcomes (i.e. higher use of maladaptive coping strategies).|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.|||units on a scale||Standard Deviation|Mean
2578290|NCT02431299|Secondary|UNCOPE Measure|"This meThis measure is a consumer rated substance abuse screener consisting of 6 yes or no questions. A response of yes is assigned a value of 1. The total number of yes responses are summed and a score of greater than 4 indicates likelihood of substance abuse. Higher scores mean worse outcomes for this scale (i.e. the higher the score, the greater the likelihood of substance abuse issues)."|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.|||units on a scale||Standard Deviation|Mean
2593118|NCT02249104|Secondary|Percent Change From Baseline in Total Lesion Count||Baseline and 8 weeks||||Percent change||Standard Deviation|Mean
2578291|NCT02431299|Secondary|Medication Adherence Rating Scale|"This is a consumer rated scale assessing medication adherence. This is a 10 item scale with each question rated as yes or no. A yes is assigned a value of 1. The scale ranges from 0 (no yes responses) to 10 (all yes responses endorsed). The total number of yes responses is totaled to create a summary score. The mean score is calculated based on averaging the summary scores for the entire consumer sample. Higher scores mean better outcomes for medication adherence."|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.|||units on a scale||Standard Deviation|Mean
2578292|NCT02431299|Secondary|Brief COPE Adaptive Subscale|This is a consumer rated assessment of adaptive coping skills. This is derived from the 28 item, full scale. The scale uses a 1-4 Likert scale, indicating the frequency of using different coping strategies. There are 14 subscales, each calculated by summing 2 items. The range on each subscale is 2 - 8. The 14 subscales are further combined into 2 larger scales - maladaptive and adaptive coping. Adaptive coping is calculated by averaging the responses from 8 out of the 14 subscales. Higher scores indicate better outcomes (i.e. higher use of adaptive coping strategies).|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.|||units on a scale||Standard Deviation|Mean
2578293|NCT02431299|Secondary|Adult State Hope Scale|"This is a consumer rated measure that assesses the level of goal related hope a consumer possesses. This version is a 6 item measure, with each item rated on a 4 point scale (range 1-4, with 1 being Definitely False and 4 being Definitely True). A summary score is calculated by summing all 6 items. Higher scores represent better outcomes (i.e. higher goal related hope). These summary scores were then averages to calculate a mean score for our sample."|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.|||units on a scale||Standard Deviation|Mean
2578294|NCT02431299|Secondary|Multidimensional Scale of Perceived Social Support|This scale is a consumer rated assessment of perceived social support systems. There are 12 items each rated on a 7 point Likert scale (ranging from 1-7). A mean score is calculated from all 12 items. Higher scores represent better outcomes (i.e. higher levels of perceived social support).|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.|||units on a scale||Standard Deviation|Mean
2578295|NCT02431299|Secondary|Working Alliance Inventory Short Form|This is a consumer rated scale indicated working alliance between consumer and clinician. The scale has 12 items, rated on a 7 point Likert style scale (ranging from 1-7). The total score provided a mean score of all 12 items. Better working alliance is indicated by a higher score.|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.|||units on a scale||Standard Deviation|Mean
2578296|NCT02431299|Primary|Illness Management and Recovery Treatment Integrity Scale|Clinician competency rating scale was used to assess clinician competence in providing IMR. This data was used to test the theory that IMR competency would impact consumers' ability to engage in illness self management practices as rated by the Illness Management and Recovery Scale. This scale is rated by trained observers, and the scale contains 16 items, rated on a 1 - 5 point scale. A 5 indicates higher competency and fidelity to the IMR treatment model. A mean score is calculated across all 16 items. Higher scores indicate higher clinician competence in providing IMR.|3-Months||||units on a scale||Standard Deviation|Mean
2578297|NCT02431299|Primary|Illness Management and Recovery Scale|Post-intervention scores were assessed. This measure is designed to assess consumer-rated illness self management skills. This scale is based on a 15 items, each rated on a 5 point Likert scale, ranging from 1 to 5. Higher numbers of this scale represent better outcomes. A mean score of all 15 items is provided as the primary outcome score for this scale.|3-Months|Every effort was made to collect post-intervention follow up data for participants. In some instances, participants were unable to provide this information (i.e. hospitalized, unable to attend data collection session, unwilling). As all outcome measures were consumer self-rated, if the consumer was unavailable data is missing for that participant.|||units on a scale||Standard Deviation|Mean
2578298|NCT02431273|Secondary|Acceptability of the IVRs|"Acceptability of the IVRs was assessed through reported willingness to use the IVR for 28 days in a real-world setting on a likert scale, 1 being not at all confident to 5 being completely confident for Periods 1 and 2."|Days 0-21 following insertion of each IVR.|Data was not collected for the third study period.|||units on a scale||Full Range|Mean
2578299|NCT02431273|Primary|Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Terminal Half-life|Drug concentrations [tenofovir disoproxil fumarate (TDF), emtricitabine (FTC) and maraviroc (MVC)] in terminal half-life were evaluated for each IVR combination.|Time points at which outcome measure was assessed are Day 7 (day of IVR removal) and daily up to 14 days.||||Hour||Inter-Quartile Range|Median
2578300|NCT02431273|Primary|Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Plasma|Drug concentrations [tenofovir disoproxil fumarate (TDF), emtricitabine (FTC) and maraviroc (MVC)] in plasma were evaluated for each IVR combination.|Time points at which outcome measure was assessed are Days 2 (after IVR insertion) and 7 (day of IVR removal).||||ng/mL||Inter-Quartile Range|Median
2578301|NCT02431273|Primary|Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Vaginal Tissue|Drug concentrations [tenofovir disoproxil fumarate (TDF), tenofovir (TFV), tenofovir diphosphate (TFV-DP), emtricitabine (FTC) and maraviroc (MVC)] in vaginal tissue (VT) were evaluated for each IVR combination.|Time points at which outcome measure was assessed are Days 2 (after IVR insertion) and 7 (day of IVR removal).||||ng/mg||Inter-Quartile Range|Median
2578302|NCT02431273|Primary|Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Cervicovaginal Lavage (CVL)|Drug concentrations [tenofovir disoproxil fumarate (TDF), emtricitabine (FTC) and maraviroc (MVC)] in cervicovaginal lavage (CVL) were evaluated for each IVR combination.|Time points at which outcome measure was assessed are Days 2 (after IVR insertion) and 7 (day of IVR removal).||||ng/mL||Inter-Quartile Range|Median
2578303|NCT02431273|Primary|Pharmacokinetics of the Single, Dual and Triple ARV IVRs: Cervicovaginal Fluid (CVF)|Drug concentrations [tenofovir (TFV), tenofovir disoproxil fumarate (TDF), emtricitabine (FTC) and maraviroc (MVC)] in cervicovaginal fluids (CVF) for each IVR combination.|Time points at which outcome measure was assessed are Days 2 (after IVR insertion) and 7 (day of IVR removal).||||ng/mg||Inter-Quartile Range|Median
2578304|NCT02431273|Primary|Number of Participants With Specific Graded Adverse Events in Single, Dual, and Triple Antiretroviral (ARV) Intravaginal Rings (IVRs)|Number of Adverse Events (AEs) was recorded. Safety parameters were monitored for each IVR combination and the grading scale for each parameter followed the Female Genital Grading Table for Use in Microbicide Studies. AEs not included in that table were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 2.0, November 2014 (Grade 1 = mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Potentially Life-Threatening).|Days 0-21 following insertion of each IVR.||||participants|||Number
2578305|NCT02431260|Secondary|Overall Survival (OS)|OS is defined as the time from the date of randomization to the date of the participant's death.|Baseline through end of study, up to 6 months for participants in Part 2|As a result of early termination of the study, only participants in Part 2 of the study were evaluated; Treatment Group C was not evaluated due to early termination from the study.|||months||95% Confidence Interval|Median
2578306|NCT02431260|Secondary|Progression Free Survival (PFS)|PFS is the time from start of study treatment to first documentation of progression, or to death due to any cause, whichever comes first|Baseline through end of study, up to 6 months|As a result of early termination of the study, only participants in Part 2 of the study were evaluated; Treatment Group C was not evaluated due to early termination from the study.|||months||95% Confidence Interval|Median
2578307|NCT02431260|Secondary|Duration of Response (DOR)|Defined as the time from earliest date of disease response until earliest date of disease progression or death.|Baseline through end of study, up to 6 months|As a result of early termination of the study, there are no participants that are responders and therefore DOR was not achieved.||||||
2578308|NCT02431260|Secondary|Objective Response Rate (ORR)|Defined as the percentage of subjects having complete response (CR) or partial response (PR). The best overall response was defined as the best response recorded before and including the first event of Progressive disease (PD).|Baseline through end of study, up to 6 months|As a result of early termination of the study, only participants in Part 2 of the study were evaluated; Treatment Group C was not evaluated due to early termination from the study.|||Participants|||Count of Participants
2578309|NCT02431260|Secondary|Pharmacodynamics (PD) Analysis - Total c-Myc % Inhibition Versus INCB054329|"The half maximal inhibitory concentration (IC50) of INCB054329 was measured. The maximal inhibition of total c-Myc was correlated to the level of drug exposure and demonstrated a high degree of interparticipant variability, parallel to the PK data.~The measure was performed as a value across all cohorts. The entire dose escalation data set was used to create the relationship curve. Analysis of individual cohorts contained too few subjects and was biased toward one region of the curve so that the relationship was poorly defined.~Individual data points from all subjects were subjected to a nonlinear least squares regression analysis with no weighting, resulting in a sigmoidal dose response curve defining the relationship. The numerical value given is the projected INCB0054329 concentration in nM that produced 50% inhibition of c-myc expression."|Day 15 in all cohorts|Individual data points from all subjects were subjected to a nonlinear least squares regression analysis with no weighting, resulting in a sigmoidal dose response curve defining the relationship. The numerical value given is the projected INCB0054329 concentration in nM that produced 50% inhibition of c-myc expression.|||nM|||Number
2578310|NCT02431260|Secondary|Cl/F Analysis of INCB054329|Cl/F is the apparent oral dose clearance measured at steady state (Day 15). Study drug was administered with 240 mL of water.|Summary of steady-state PK parameters by dosing regimen at Day 15|All enrolled patients who received at least 1 dose of study medication and provided at least 1 plasma sample were included.|||L/h||Standard Deviation|Mean
2578311|NCT02431260|Secondary|AUC0-t Analysis of INCB054329|"AUC0-t is the area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).~Study drug was administered with 240 mL of water."|Summary of steady-state PK parameters by dosing regimen at Day 15|All enrolled patients who received at least 1 dose of study medication and provided at least 1 plasma sample were included.|||nM*h||Standard Deviation|Mean
2578312|NCT02431260|Secondary|Minimum Observed Plasma Concentration Over the Dose Interval (Cmin) Analysis of INCB054329|Minimum observed plasma concentration measured at steady state (Day 15). Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.|Summary of steady-state PK parameters by dosing regimen at Day 15|All enrolled patients who received at least 1 dose of study medication and provided at least 1 plasma sample were included.|||nM||Standard Deviation|Mean
2578313|NCT02431260|Secondary|Time to Maximum Plasma Concentration (Tmax) Analysis of INCB054329|Tmax is the time to maximum (peak) drug serum concentration. Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen.|Summary of steady-state PK parameters by dosing regimen at Day 15|All enrolled patients who received at least 1 dose of study medication and provided at least 1 plasma sample were included.|||hour||Full Range|Median
2578314|NCT02431260|Secondary|Maximum Plasma Concentration (Cmax) Analysis of INCB054329|"Cmax is defined as the maximum observed serum concentration measured at steady state (Day 15).~Study drug was administered with 240 mL of water. Summary of Steady-State, Day 15, was evaluated by dosing regimen."|Summary of steady-state PK parameters by dosing regimen at Day 15|All enrolled patients who received at least 1 dose of study medication and provided at least 1 plasma sample were included.|||nM||Standard Deviation|Mean
2578315|NCT02431260|Primary|Number of Participants With a Treatment-emergent Adverse Event (TEAE)|TEAE is defined as an adverse event reported for the first time or worsening of a pre-existing event after the first dose of study treatment.|up to 30 days|The safety population included all enrolled participants who received at least 1 dose of INCB054329.|||Participants|||Count of Participants
2578316|NCT02431247|Secondary|Change From Baseline in Levels of 25-Hydroxyvitamin D (25-OH Vitamin D), at Week 24 and 48|Change from baseline in 25-OH Vitamin D at Week 24 and 48 were reported.|Baseline, Weeks 24 and 48|BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here 'n' (number analyzed) signifies number of participants analyzed at specific timepoint.|||nanomol per liter (nmol/L)||Standard Error|Mean
2578317|NCT02431247|Secondary|Change From Baseline in Levels of Parathyroid Hormone (PTH) at Week 24 and 48|Change from baseline in PTH at Week 24 and 48 were reported.|Baseline, Weeks 24 and 48|BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here 'n' (number analyzed) signifies number of participants analyzed at specific timepoint.|||Picomol per liter (pmol/L)||Standard Error|Mean
2578318|NCT02431247|Secondary|Change From Baseline in Levels of Serum Collagen Type 1 Beta Carboxy Telopeptide (CTX) at Week 24 and 48|Change from baseline in serum CTX at Week 24 and 48 were reported.|Baseline, Weeks 24 and 48|BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here 'n' (number analyzed) signifies number of participants analyzed at specific timepoint.|||mcg/L||Standard Error|Mean
2578319|NCT02431247|Secondary|Change From Baseline in Levels of Serum Procollagen 1 N-Terminal Propeptide (P1NP) at Week 24 and 48|Change from baseline in serum P1NP at Week 24 and 48 were reported.|Baseline, Weeks 24 and 48|BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here 'n' (number analyzed) signifies number of participants analyzed at specific timepoint.|||microgram per liter (mcg/L)||Standard Error|Mean
2578320|NCT02431247|Secondary|Change From Baseline in Alkaline Phosphatase (ALP) Levels at Week 24 and 48|Change from baseline in ALP at Week 24 and 48 were reported.|Baseline, Weeks 24 and 48|BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here 'n' (number analyzed) signifies number of participants analyzed at specific timepoint.|||Units per liter (U/L)||Standard Error|Mean
2578321|NCT02431247|Secondary|Change From Baseline in BMD T-score of Hip and Spine|BMD status was assessed using BMD T-scores; normal bone status was defined by a BMD T-score >= -1, osteopenia by a T-score >= -2.5 to <-1.0, and osteoporosis by a T-score <-2.5.|Baseline, Weeks 24 and 48|BIS analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here 'n' (number analyzed) signifies number of participants analyzed at specific timepoint.|||BMD T-score||Standard Error|Mean
2578322|NCT02431247|Secondary|Percent Change From Baseline in Hip and Spine Bone Mineral Density (BMD)|"The BMD is the amount of mineral in gram per square centimeter of bone, which was assessed by dual energy x-ray absorptiometry (DEXA) scan. Positive values are best values and negative values are worst values of change. Percent change from baseline in hip and spine BMD was assessed."|Baseline, Weeks 24 and 48|Bone investigation substudy (BIS) analysis set included all participants who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here 'n' (number analyzed) signifies number of participants analyzed at specific timepoint.|||Percent change||Standard Error|Least Squares Mean
2578323|NCT02431247|Secondary|Plasma Concentrations 2 Hours After Dosing (C0-2h) of Tenofovir Alafenamide|C0-2h is defined as as the plasma concentrations 2 hours after dosing.|30 minutes to 4 hours postdose at Weeks 2, 4, 12, 24 and 48 and at 2 timepoints with at least 2.5 hours in between sampling at Week 8 and 36 (first sample between 1 and 4 hours postdose)|Pharmacokinetic(PK) analysis set: all participants who were randomized, received at least 1 dose of study drug and plasma concentration data for analytes of interest were available. PK data of TAF was analyzed only for test arm as per planned analyses. 'N'(number of participants analyzed): number of participants evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2578324|NCT02431247|Secondary|Area Under the Plasma Concentration Time Curve Across the Dosing Interval (AUCtau) of Tenofovir Alafenamide|The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption.|30 minutes to 4 hours postdose at Weeks 2, 4, 12, 24 and 48 and at 2 timepoints with at least 2.5 hours in between sampling at Week 8 and 36 (first sample between 1 and 4 hours postdose)|Pharmacokinetic(PK) analysis set: all participants who were randomized, received at least 1 dose of study drug and plasma concentration data for analytes of interest were available. PK data of TAF was analyzed only for test arm as per planned analyses. 'N'(number of participants analyzed): number of participants evaluable for this outcome measure.|||h*ng/mL||Standard Deviation|Mean
2578325|NCT02431247|Secondary|Predose (Trough) Plasma Concentration (C0h) of Darunavir|C0h is defined as the predose (trough) plasma concentration or concentration just prior to study drug administration.|30 minutes to 4 hours postdose at Weeks 2, 4, 12, 24 and 48 and at 2 timepoints with at least 2.5 hours in between sampling at Week 8 and 36 (first sample between 1 and 4 hours postdose)|Pharmacokinetic(PK) analysis set: all participants who were randomized, received at least 1 dose of study drug and plasma concentration data for analytes of interest were available. PK data of DRV was analyzed only for test arm as per planned analyses. 'N'(number of participants analyzed): number of participants evaluable for this outcome measure.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2578326|NCT02431247|Secondary|Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) of Darunavir|The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours post dose.|30 minutes to 4 hours postdose at Weeks 2, 4, 12, 24 and 48 and at 2 timepoints with at least 2.5 hours in between sampling at Week 8 and 36 (first sample between 1 and 4 hours postdose)|Pharmacokinetic(PK) analysis set: all participants who were randomized, received at least 1 dose of study drug and plasma concentration data for analytes of interest were available. PK data of DRV was analyzed only for test arm as per planned analyses. 'N'(number of participants analyzed): number of participants evaluable for this outcome measure.|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
2578349|NCT02430870|Secondary|AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2578327|NCT02431247|Secondary|Percent Change From Baseline in Urine Fractional Excretion of Phosphate (FEPO4) at Week 48|Percent change from baseline in FEPO4 at Week 48 were reported.|Baseline and Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Percent change||Full Range|Median
2578328|NCT02431247|Secondary|Change From Baseline in Urine Beta-2 Microglobulin to Creatinine Ratio (UB2MGCR) at Week 48|Change from baseline in UB2MGCR at Week 48 were reported.|Baseline and Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||mcg/g||Full Range|Median
2578329|NCT02431247|Secondary|Change From Baseline in Urine Retinol Binding Protein To Creatinine Ratio (URBPCR) at Week 48|Change from baseline in URBPCR at Week 48 were reported.|Baseline and Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||microgram per gram (mcg/g)||Full Range|Median
2578330|NCT02431247|Secondary|Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) at Week 48|Change from baseline in UACR at Week 48 were reported.|Baseline and Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||mg/g||Full Range|Median
2578331|NCT02431247|Secondary|Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48|Change from baseline in UPCR at Week 48 were reported.|Baseline and Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||milligram per gram (mg/g)||Full Range|Median
2578332|NCT02431247|Secondary|Percentage of Participants With Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuations Due to Adverse Events|AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.|Up to Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.|||Percentage of participants|||Number
2578333|NCT02431247|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula at Week 48|Change from baseline in eGFRcyst was calculated using the CKD-EPI equation as per which Stage 1 (normal or high GFR) >= 90 indicates normal kidney function; Stage 2 (Mild CKD): 60 to 89 mL/min indicates mildly reduced kidney function; Stage 3 (Moderate CKD): 30 to 59 mL/min indicates moderately reduced kidney function; Stage 4 (Severe CKD): 15 to 29 mL/min indicates severely reduced kidney function; Stage 5 (End Stage of CKD): <15 mL/min indicate very severe or end stage kidney failure. The eGFRcyst was assessed by calculated serum cystatin C (Scyst) using the CKD-EPI equation: eGFRcyst mL/min/1.73m^2 = 133 x (Scyst/0,8)^-0.499 x 0.996^age [x 0.932 if female] (Scyst =<0.8 mg/L) and eGFRcr mL/min/1.73m^2 = 133 x (Scyst/0,8)^-1.328 x 0.996^age [x 0.932 if male] (Scyst >0.8 mg/L).|Baseline and Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||mL/min/1.73 m^2||Standard Error|Least Squares Mean
2578334|NCT02431247|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine by (Cockcroft-Gault Formula) at Week 48|Change from baseline in eGFRcr by (cockcroft-gault formula) at Week 48. The eGFRcr was assessed by calculated creatinine clearance (CrCl) using the Cockcroft-Gault formula, and was assessed using CrCl [mL/min] = (140 - A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit (kilogram [kg]), C is the serum concentration of creatinine [mg/dL], R = 1 if the participant is male and = 0.85 if female.|Baseline and Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||milliliter per minute (mL/min)||Standard Error|Least Squares Mean
2578335|NCT02431247|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Formula at Week 48|Change from baseline in eGFRcr was calculated using the CKD-EPI equation as per which Stage 1 (normal or high GFR) >= 90 indicates normal kidney function; Stage 2 (Mild CKD): 60 to 89 mL/min indicates mildly reduced kidney function; Stage 3 (Moderate CKD): 30 to 59 mL/min indicates moderately reduced kidney function; Stage 4 (Severe CKD): 15 to 29 mL/min indicates severely reduced kidney function; Stage 5 (End Stage of CKD): <15 mL/min indicate very severe or end stage kidney failure. The eGFRcr was assessed by calculating serum creatinine (Scr) using the CKD-EPI equation: eGFRcr milliliter per minute per 1.72 meter square (mL/min/1.73m^2) = 144 x (Scr/0.7)^-0.329 x 0.993^age (Scr =< 0.7 mg/dL) and eGFRcr mL/min/1.73m^2 = 144 x (Scr/0.7)^-1.209 x 0.993^age (Scr >0.7 mg/dL) for female participants and eGFRcr mL/min/1.73m^2 = 141 x (Scr/0.9)^-0.411 x 0.993^age (Scr =<0.9 mg/dL) and eGFRcr mL/min/1.73m^2 = 141 x (Scr/0.9)^-1.209 x 0.993^age (Scr >0.9 mg/dL) for male participants.|Baseline and Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||mL/min/1.73 m^2||Standard Error|Least Squares Mean
2578350|NCT02430870|Secondary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2578336|NCT02431247|Secondary|Change From Baseline in Serum Creatinine at Week 48|Change from baseline in serum creatinine at Week 48 was reported. Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine.|Baseline and Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
2578337|NCT02431247|Secondary|Number of Participants With Antiretroviral (ARV) Resistance Through Week 48|Number of participants with DRV, FTC, TDF/TAF resistance were reported.|Up to Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.|||Participants|||Number
2578338|NCT02431247|Secondary|Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Week 48|The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Week 48 were assessed.|Baseline and Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Based on NC = F analysis with values after discontinuation imputed with the baseline value. Other (intermittent) missing values are imputed using LOCF.|||Cells per millimeter cube (cells/mm^3)||Standard Error|Least Squares Mean
2578339|NCT02431247|Secondary|Change From Baseline in log10 HIV-1 RNA Levels at Week 48|Change from baseline in log10 HIV-1 RNA levels were reported.|Baseline and Week 48|The ITT analysis set included all participants who were randomized and received at least one dose of study treatment in study. Based on not completed (NC) equal to (=) failure (F) analysis with values after discontinuation imputed with the baseline value. Other (intermittent) missing values are imputed using last observation carried forward (LOCF).|||log10 HIV-1 RNA copies per mL||Standard Error|Least Squares Mean
2578340|NCT02431247|Secondary|Percentage of Participants With HIV-1 RNA < 20, 50, and 200 Copies Per mL at Week 48 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|Percentage of participants with HIV-1 RNA less than 20, 50, and 200 copies per mL at Week 48 based on TLOVR algorithm were assessed. TLOVR requires sustained HIV-1 RNA < 50 copies per mL; confirmed HIV-1 RNA >= 50 copies per mL is considered as non-response (rebound); participant is considered non-responder after permanent discontinuation.|At Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.|||Percentage of participants||95% Confidence Interval|Number
2578341|NCT02431247|Secondary|Percentage of Participants With HIV-1 RNA Less Than 20 and 200 Copies Per mL at Week 48 Defined by FDA Snapshot Approach|Percentage of participants with HIV-1 RNA < 20/200 copies per mL using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48), 2) virologic failure (HIV RNA >= 20/50/200 copies per mL at Week 48 ), 3) no viral load data in the Week 48 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response.|At Week 48|The ITT analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.|||Percentage of participants||95% Confidence Interval|Number
2578342|NCT02431247|Primary|Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies Per mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach|Percentage of participants with a HIV-1 RNA < 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The snapshot approach classified participants into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48), 2) virologic failure (HIV RNA greater than or equal to [>=] 20/50/200 copies per mL at Week 48), 3) no viral load data in the Week 48 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response.|At Week 48|The intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least one dose of study treatment in the study.|||Percentage of participants||95% Confidence Interval|Number
2578343|NCT02431052|Primary|Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12|"Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12~Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions~- Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion~- Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions)~- Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion~- Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions"|Baseline and Week 12|Intent-to-Treat|||Participants|||Count of Participants
2578344|NCT02431052|Primary|Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12|Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12|Baseline and Week 12|Intent-To-Treat|||Lesions||Standard Deviation|Least Squares Mean
2578345|NCT02431052|Primary|Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12|Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12|Baseline and Week 12|Intent-to-Treat|||Lesions||Standard Deviation|Least Squares Mean
2578346|NCT02430870|Secondary|AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2578347|NCT02430870|Secondary|AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 Over the Dosing Interval for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2578351|NCT02430870|Secondary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2578352|NCT02430870|Secondary|Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.|||hr||Full Range|Median
2578353|NCT02430870|Secondary|Tmax: Time to Reach Maximum Plasma Concentration (Tmax) for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.|||hours (hr)||Full Range|Median
2578354|NCT02430870|Secondary|Cmax: Maximum Plasma Concentration for TAK-648 for Part 2||Days 1 and 10 pre-dose and multiple time-points post-dose (Up to 72 hours)|The PK Set included all participants in the safety set with at least 1 measurable plasma concentration.|||mg/mL||Standard Deviation|Mean
2578355|NCT02430870|Secondary|Cmax: Maximum Plasma Concentration for TAK-648 for Part 1||Days 1 and 17 pre-dose and multiple time-points post-dose (Up to 72 hours)|The Pharmacokinetic (PK) Set included all participants in the safety set with at least 1 measurable plasma concentration.|||ng/mL||Standard Deviation|Mean
2578356|NCT02430870|Primary|Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 2|Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.|Up to Day 13|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2578357|NCT02430870|Primary|Percentage of Participants Who Have Severe Hypoglycemia at Least Once Post-dose During Dosing For Part 1|Severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.|Up to Day 20|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2578358|NCT02430870|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 2|Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm),|Up to Day 13|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2578359|NCT02430870|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose During Dosing for Part 1|Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (bpm).|Up to Day 20|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2578360|NCT02430870|Primary|Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 2||Up to Day 13|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2578361|NCT02430870|Primary|Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose During Dosing for Part 1||Up to Day 20|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2578362|NCT02430870|Primary|Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) for Part 2|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to Day 26|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2578363|NCT02430870|Primary|Percentage of Participants Who Have at Least 1 Treatment-Emergent Adverse Event (TEAE) for Part 1|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to Day 34|Safety Analysis Set included of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2578364|NCT02430818|Secondary|Would the Participant Would Consider Using the Drug Given to Them for Pain Relief in the Future|Patients will be assessed to determine whether the participant would consider using the drug given to them for pain relief in the future. It was measured on a likert scale from 1-5 with 1 being did not like and would not use the drug again to 5 being like and would definitely receive the medication again. There are no units. The numbers below are the total number of patients that completed this answer. This was only asked on patients that received medication as if they did not receive medication the answer would not make sense. The median value is the likert value on a scale of 1-5 with the standard deviation.|60 minutes|We describe all patients that received medication. One patient randomized to morphine did not receive any study medication as her pain improved after being splinted to the extent that she did not have any pain. Two patients were screened and did not meet criteria for inclusion. We used simple, descriptive statistics.|||units on a scale||Standard Deviation|Median
2578365|NCT02430818|Secondary|Number of Participants With an Adverse Effects|We will monitor for adverse effects and record for changes in vital signs including nausea and vomiting, hypotension, respiratory depression, laryngospasm, and emotional and psychological effects (emergence reactions).|60 minutes|We will include the number of patients with adverse events. Given the very small sample size and small number of events, we are just including total numbers.|||participants|||Number
2578366|NCT02430818|Primary|Pain Treatment-VAS (Visual Analog Scale)|Study outcomes involve change in participants' pain as measured by a visual analog scale. The scale is a 10 inch line from 0 to 10 inches with 10 being the most pain and 0 being no pain. There are no units on the scale; it is just a straight line from no pain (0) to the worst pain (10). We assessed at o, 15, and 60 minutes but only scored the VAS at 60 minutes.|At 0 minutes and 60 minutes||||score on a scale||Standard Deviation|Median
2578367|NCT02430532|Secondary|Change From Baseline to Week 108 in Cognitive Function as Measured by the Symbol Digit Modalities Test (SDMT)|The SDMT measures the time to pair abstract geometric symbols with specific numbers. The score is the number of correctly coded items from 0-110 in 90 seconds. A higher score indicates a better outcome.|Baseline, Week 108|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2578368|NCT02430532|Secondary|Percentage Change From Baseline to Week 108 in Whole Brain Volume|Whole brain volume is measured by magnetic resonance imaging (MRI).|Baseline, Week 108|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2578369|NCT02430532|Secondary|Change From Baseline to Week 108 in ABILHAND Questionnaire Score|The ABILHAND Questionnaire measures the participant's perceived difficulty in performing everyday manual activities in the last 3 months. Participants fill in the 56-item questionnaire by estimating their own difficulty or ease in performing each of the 56 activities. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where high scores indicate greater impact on manual ability.|Baseline, Week 108|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2578370|NCT02430532|Secondary|Change From Baseline to 2 Years on the 12-Item Multiple Sclerosis Walking Scale (MSWS-12)|MSWS-12 is a participant self-assessment of walking limitations due to multiple sclerosis (MS) during the past 2 weeks. It contains 12 items that measure the impact of MS on walking. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where high scores indicate greater negative impact on walking.|Baseline, 2 years|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2578371|NCT02430532|Primary|Time to Disability Progression Independent of Relapse|Time to onset of confirmed progression of disability is defined as 1 or more of the following criteria, confirmed at ≥ 6 months after start of treatment and at Week 108 using 1 or more of the following assessments: Expanded Disability Status Scale (EDSS) score increased from Baseline of ≥ 1 point if baseline EDSS ≤ 5.5, or ≥ 0.5 point if Baseline EDSS ≥ 6.0; Timed 25-Foot Walk (T25FW) ≥ 20% increase from Baseline in the time taken for the 25-foot walk; worsening on the 9-Hole Peg Test (9HPT; ≥ 20% increase from Baseline in the time taken for the 9HPT, confirmed in the same hand). The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. The T25FW is a quantitative mobility and leg function performance test where the participant is timed while walking for 25 feet. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs.|Up to 108 weeks|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2578372|NCT02430389|Secondary|Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations||10 minute window after head fixation||||participants|||Number
2578373|NCT02430389|Primary|Mean Arterial Blood Pressure After Head Fixation||Ten minute window after head fixation||||mm Hg||Standard Deviation|Mean
2578374|NCT02430337|Primary|SafeCare Time Diary|Provider participants documented their time spent on SafeCare session preparation, completion, and follow-up using a time diary. This form was used to document the time home visitors spend on job-related activities such as preparing for home visits, conducting home visits, and completing notes, among other activities. All participants completed the form following each SafeCare session they complete during the six months of the study. The total number of time diaries completed will vary depending on the home visitor's caseload. Means were computed based on an average of the time diaries submitted per study arm and wer compared for differences.|average of provider time preparing for and completing SafeCare sessions during the study period (6 months)||||Minutes||Standard Deviation|Mean
2578375|NCT02430337|Primary|SafeCare Provider Implementation Status|The investigators used 4 categories to indicate the status of the SafeCare providers at the end of their study participation, these groups: completed were workshop only, started SafeCare but became inactive, started and continued SafeCare active (but not certified), SafeCare certified (completed 9 family sessions with 85% fidelity)|Status of provider at end of study participation||||percentage of providers certified|||Number
2578376|NCT02430337|Primary|SafeCare Fidelity|The SafeCare fidelity checklist measures 30+ clinical behaviors that SafeCare providers are expected to deliver during an hour long SafeCare session. Fidelity on each behavior is scored as a + if occurs and a - if does not occur. Percentages are computed for the number of +'s divided by the number of total behaviors. Scores range from 0 to 100%, with higher numbers indicating higher fidelity. A score of 85% or greater is indicative of high competence with SafeCare delivery. SafeCare providers receive fidelity monitoring for nine sessions (three in each of three modules) until they reach certification and once per month thereafter. All fidelity scores for the participants will be collected from baseline assessment to six-month follow-up in order to assess the effect of implementation condition on fidelity scores. The frequency of fidelity assessment will vary depending on the caseload of each home visitor participant.|The average of up to 9 scores across 6 months||||percentage of behaviors implemented||Standard Deviation|Mean
2578377|NCT02430337|Primary|Number of Providers Reporting Satisfaction With Technology|The investigators examined provider qualitative feedback to count the number of participants reporting that the Technology-Assisted SafeCare was acceptable and feasible. Interview data was transcribed and summarized to examine themes reported by the Tech-Assisted SafeCare providers' at the time of their exit interview (approximately six months after the baseline assessment).|Approximately six months after completing the baseline assessment|Qualitative data were summarized for 14 of the 20 SafeCare Technology-Assisted Providers, who completed an exit interview regarding the technology usability|||Participants|||Count of Participants
2578378|NCT02430311|Primary|Steady State PK Parameter--CLss/F at Day 8|Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - CLss/F (PK analysis set)|PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8|PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.|||L/h||Standard Deviation|Mean
2578379|NCT02430311|Primary|Steady State PK Parameter--tmax, ss at Day 9|Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - tmax, ss (PK analysis set)|PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 9|PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.|||hour||Full Range|Median
2578380|NCT02430311|Primary|Steady State PK Parameter--AUCss at Day 9|Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - AUC (PK analysis set)|PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 9|PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2578381|NCT02430311|Primary|Steady State PK Parameter--Cmax, ss and Cmin, ss at Day 9|Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - Cmax, ss and Cmin, ss (PK analysis set)|PK samples were collected pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 9|PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2578382|NCT02430311|Primary|Steady State PK Parameter--RAC and TCP at Day 8|Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - RAC and TCP (PK analysis set)|PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8|PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.|||Ratio||Standard Deviation|Mean
2578383|NCT02430311|Primary|Steady State PK Parameter--tmax, ss at Day 8|Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - tmax, ss (PK analysis set)|PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8|PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.|||hour||Full Range|Median
2578384|NCT02430311|Primary|Steady State PK Parameter--AUCss at Day 8|Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - AUC (PK analysis set)|PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8|PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2578385|NCT02430311|Primary|Steady State PK Parameter--Cmax, ss and Cmin, ss at Day 8|Steady state pharmacokinetic parameter summary for olaparib by dose and visit after multiple doses - Cmax, ss and Cmin, ss (PK analysis set)|PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post morning dose of Day 8|PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2578386|NCT02430311|Primary|Single Dose PK Parameter--CL/F|Single dose PK parameter summary for olaparib in monotherapy by dose - CL/F (PK analysis set)|PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)|PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.|||L/h||Standard Deviation|Mean
2578387|NCT02430311|Primary|Single Dose PK Parameter--Vz/F|Single dose PK parameter summary for olaparib in monotherapy by dose - Vz/F (PK analysis set)|PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)|PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.|||L||Standard Deviation|Mean
2578388|NCT02430311|Primary|Single Dose PK Parameter--t1/2, λz|Single dose PK parameter summary for olaparib in monotherapy by dose - t1/2, λz (PK analysis set)|PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)|PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.|||hour||Standard Deviation|Mean
2578389|NCT02430311|Primary|Single Dose PK Parameter--tmax|Single dose PK parameter summary for olaparib in monotherapy by dose - tmax (PK analysis set)|PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)|PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.|||hour||Full Range|Median
2578390|NCT02430311|Primary|Single Dose PK Parameter--AUC|Single dose PK parameter summary for olaparib in monotherapy by dose - AUC (PK analysis set)|PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)|PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2578391|NCT02430311|Primary|Single Dose PK Parameter--Cmax|Single dose PK parameter summary for olaparib in monotherapy by dose - Cmax (PK analysis set)|PK samples were collected pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 (Day 2) and 48 h (Day 3)|PK analysis set, which includes all patients who receive an olaparib dose and provide evaluable PK profiles in at least 1 treatment period.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2578392|NCT02430090|Secondary|Number of Participants With Pain Scores on the Visual Analog Scale|Hemodynamic parameters, characteristics of sensory and motor blockade, peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the first analgesic requirement were recorded.|Up to 4 months|||||||
2578393|NCT02430090|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The frequency and the severity (ex) of the side effects including nausea and vomiting, hypotension, pruritus, and bradycardia were recorded.|Up to 4 months||||participants|||Number
2578394|NCT02429869|Secondary|Plasma HIV RNA|Plasma HIV RNA was quantified in a highly sensitive single-copy assay (SCA) using repetitive sampling in the Panther system (Hologic) at the Blood Systems Research Institute. Up to 18 replicates were tested for each sample in order to determine plasma RNA levels as low as 0.18 copies/mL.|Baseline, Month 2, Month 6, Month 12 (6 months post discontinuation of everolimus)|CD4+ T Cell count was not collected at Month 6 for one participant who did not show up for the visit.|||nucleic acid copies per million cells||Inter-Quartile Range|Median
2578395|NCT02429869|Secondary|Cell-associated Total HIV RNA|Peripheral blood mononuclear cells were isolated from whole blood using the Ficoll density gradient technique. Peripheral blood CD4 T cells were enriched by negative selection using antibody-coupled magnetic beads (Stem Cell Technologies) prior to simultaneous RNA and DNA isolation using cell-sparing protocols (AllPrep, Qiagen). Bulk CD4+ T cell or PBMC-associated HIV DNA and unspliced RNA were quantified using real-time PCR methods.The primer and probe sequences targeted conserved regions to enable quantification of a broad range of HIV subtypes. Values were normalized to DNA quantification of a human housekeeping gene (CCR5) in order to determine nucleic acid copies per million CD4+ T cell or PBMC as described. In addition to traditional quantitative PCR, a novel single-cell-in-droplet (scd)PCR method was used to quantify the absolute number or frequency of individual purified CD4+ T cells that express unspliced HIV RNA.|Baseline, Month 2, Month 6, Month 12 (6 months post discontinuation of everolimus)|CD4+ T Cell count was not collected at Month 6 for one participant who did not show up for the visit.|||nucleic acid copies per million cells||Inter-Quartile Range|Median
2578396|NCT02429869|Primary|Cell-associated HIV DNA|Peripheral blood mononuclear cells were isolated from whole blood using the Ficoll density gradient technique. Peripheral blood CD4 T cells were enriched by negative selection using antibody-coupled magnetic beads (Stem Cell Technologies) prior to simultaneous RNA and DNA isolation using cell-sparing protocols (AllPrep, Qiagen). Bulk CD4+ T cell or PBMC-associated HIV DNA and unspliced RNA were quantified using real-time PCR methods.The primer and probe sequences targeted conserved regions to enable quantification of a broad range of HIV subtypes. Values were normalized to DNA quantification of a human housekeeping gene (CCR5) in order to determine nucleic acid copies per million CD4+ T cell or PBMC as described. In addition to traditional quantitative PCR, a novel single-cell-in-droplet (scd)PCR method was used to quantify the absolute number or frequency of individual purified CD4+ T cells that express unspliced HIV RNA.|Baseline, Month 2, Month 6, Month 12 (6 months post discontinuation of everolimus)|CD4+ T Cell count was not collected at Month 6 for one participant who did not show up for the visit.|||nucleic acid copies per million cells||Inter-Quartile Range|Median
2578397|NCT02429856|Secondary|Knee Range of Motion|Knee Range of Motion measured as a calculated total of knee flexion + knee extension; measured in degrees|knee ROM at 2 years postoperative||||degrees||Standard Deviation|Mean
2578398|NCT02429856|Secondary|Number of Complications||within 10 years of surgery|These complications include the revisions already recorded.|||Participants|||Count of Participants
2578399|NCT02429856|Secondary|Revision Rate|number of participants with revision surgery (ie another surgery on the same knee) for any cause data obtained from patient report and regional administrative databases|within 10 years of surgery||||Participants|||Count of Participants
2578400|NCT02429856|Secondary|RAND -36 Health Survey|generic patient reported health related quality of life measure with 8 dimensions of health - we report the physical function dimension only with scores ranging from 0-100 where higher scores indicate better physical function.|10 years postoperative||||units on a scale||Standard Deviation|Mean
2578401|NCT02429856|Primary|WOMAC Osteoarthritis Index Function|disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores|10 years||||units on a scale||Standard Deviation|Mean
2578402|NCT02429856|Primary|Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain|disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores|10 years postoperative||||units on a scale||Standard Deviation|Mean
2578403|NCT02429791|Other Pre-specified|Change From LS Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-CAR Late Switch Group Through Late Switch Phase|Blood samples were collected for CD4+ cell count assessment by flow cytometry. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value.|LS Baseline (Week 48), Weeks 100 and 148|LS ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||Cells/mm^3||Standard Deviation|Mean
2578404|NCT02429791|Other Pre-specified|Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-CAR Late Switch Group Through Late Switch Phase|Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV 1 RNA < 50 c/mL using the FDA snapshot algorithm was assessed. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest.|Weeks 100 and 148|LS ITT-E Population|||Percentage of participants|||Number
2578405|NCT02429791|Other Pre-specified|Change From Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-DTG+RPV Early Switch Group Through Early and Late Switch Phase|Blood samples were collected for CD4+ cell count assessment by flow cytometry. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1), Weeks 100 and 148|ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||Cells/mm^3||Standard Deviation|Mean
2578406|NCT02429791|Other Pre-specified|Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-DTG+RPV Early Switch Group Through Early and Late Switch Phase|Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV 1 RNA < 50 c/mL using the FDA snapshot algorithm was assessed. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest.|Weeks 100 and 148|ITT-E Population|||Percentage of participants|||Number
2578413|NCT02429791|Secondary|Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class|Blood samples were collected at Baseline (Day 1), Weeks 24 and 48 to assess fasting lipids which included total cholesterol (CHO), LDL cholesterol, HDL cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1), Week 24 and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||mmol/mL||Standard Deviation|Mean
2593119|NCT02249104|Primary|Mean Change From Baseline in Total Lesion Count||Baseline and 8 weeks||||Lesions counted||Standard Deviation|Mean
2578407|NCT02429791|Secondary|Change From LS Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148-CAR Late Switch Group Through Late Switch Phase|HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis. Value obtained at Week 48 was considered as LS Baseline value. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value.|LS Baseline (Week 48), Week 56, Week 76, Week 100 and Week 148|LS ITT-E Population. Only those participants with data available at the specified time points were analyzed.|||Scores on a scale||Full Range|Median
2578408|NCT02429791|Secondary|Change From Baseline Treatment Satisfaction Using HIV TSQ at Weeks 56, 76, 100 and 148 - DTG+RPV Early Switch Group Through Early and Late Switch Phase|HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis. Value obtained at Day 1 was considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1), Week 56, Week 76, Week 100 and Week 148|ITT-E Population|||Scores on a scale||Full Range|Median
2578409|NCT02429791|Secondary|Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase|HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis. Value obtained at Day 1 was considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1), Week 4, Week 24 and Week 48|ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Scores on a scale||Full Range|Median
2578410|NCT02429791|Secondary|Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Late Switch Group Through Late Switch Phase|Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in participant. Symptom count is the sum of number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is unweighted sum of the bother item scores for each symptom. Symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). LOCF was used as primary method of analysis. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value. Value at Week 48 was considered as LS Baseline value.|LS Baseline (Week 48), Week 56, Week 76, Week 100 and Week 148|LS ITT-E Population comprised of all participants randomized to CAR who received at least one dose of study treatment at or after the Week 52 Switch visit. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2578411|NCT02429791|Secondary|Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Early Switch Group Through Early and Late Switch Phase|Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in participant. Symptom count is the sum of number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is unweighted sum of the bother item scores for each symptom. Symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). LOCF was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value. Day 1 was considered as Baseline value.|Baseline (Day 1), Week 56, Week 76, Week 100 and Week 148|ITT-E Population. Only those participants with data available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2578412|NCT02429791|Secondary|Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase|Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in participant. Symptom count is the sum of number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is unweighted sum of the bother item scores for each symptom. Symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). Last observation carried forward (LOCF) was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value. Day 1 was considered as Baseline value.|Baseline (Day 1), Week 4, Week 24 and Week 48|ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2578414|NCT02429791|Secondary|Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class|For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were to be analyzed in an attempt to obtain phenotype data on as many samples as possible. Samples for drug resistance testing (phenotypic) were to be collected at Day 1. Number of participants with phenotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. This outcome was not analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.|Up to Week 48|CVW resistance Population||||||
2578415|NCT02429791|Secondary|Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class|For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were to be analyzed in an attempt to obtain genotype data on as many samples as possible. Samples for drug resistance testing (genotypic) were to be collected at Day 1. Number of participants with genotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. This outcome has not been analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.|Up to Week 48|CVW resistance Population||||||
2578416|NCT02429791|Secondary|Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class|Blood samples were collected to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, MCV, RBC count, WBC count and platelet count. Value at Day 1 was considered as Baseline. Number of participants who experienced maximum toxicity grade post-Baseline in hematology parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) was summarized. Hematology toxicities were graded using DAIDS grading table for grading severity of adult and pediatric adverse events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.|Up to 48 weeks|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2578417|NCT02429791|Secondary|Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class|Blood samples were collected to evaluate ALT, albumin, ALP, AST, total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, BUN, total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Value at Day 1 was considered as Baseline. Number of participants who experienced maximum toxicity grade post-Baseline in chemistry parameters over 48 weeks by Baseline third agent treatment class (INI, NNRTI, PI) was summarized. Clinical chemistry toxicities were graded using DAIDS grading table for grading severity of adult and pediatric adverse events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.|Up to 48 weeks|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2578418|NCT02429791|Secondary|Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any AE, AELD or AE with maximum grade toxicity experienced by any one participant over 48 weeks by Baseline third agent class (INI, NNRTI, or PI) was summarized. AEs were graded as per DAIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.|Up to 48 weeks|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2578419|NCT02429791|Secondary|Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class|Blood samples were collected for CD4 cell count assessment by flow cytometry was carried out to assess the impact of Baseline third agent class (INI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Value at Day 1 was considered as Baseline. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Cells per mm^3||Standard Deviation|Mean
2578420|NCT02429791|Secondary|Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class|Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 48 using the FDA snapshot algorithm was assessed by Baseline third agent class to assess the impact of Baseline third agent class (INI, NNRTI, or PI) on efficacy of DTG +RPV compared to continuation of CAR. Plasma samples were collected for quantitative analysis of HIV-1 RNA. The analysis was done using Cochran-Mantel Haenszel test stratified by current antiretroviral third-agent class and age group.|Week 48|ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Percentage of participants|||Number
2578421|NCT02429791|Secondary|Pre-dose Concentrations of DTG and RPV at Weeks 2, 4 and 8 in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV|Two blood samples were collected pre-dose for DTG and RPV at Weeks 2,4 and 8 only for the first 20 participants who switch from EFV or NVP to DTG + RPV. One blood sample was collected pre-dose for EFV or NVP at Week 2 for the first 20 participants who switch from EFV or NVP to DTG + RPV. PK Parameter NNRTI Subset Extra Sampling Population consisted of the first approximately 20 participants in the PK Parameter NNRTI Subset population who have extra PK samples at weeks 2,4 and 8.|Pre-dose at Week 2, 4 and 8|PK Parameter NNRTI Subset extra sampling Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||ug/ L||Standard Deviation|Mean
2578455|NCT02429583|Secondary|Gene Expression Profile of Conventional Dendritic Cells Measured by RNA-Seq|Isolated from patient PBMCs measured at 8 months|8 months|The data was not collected and the analysis was not completed for this study due to insufficient enrollment.||||||
2578422|NCT02429791|Secondary|Pre-dose Concentrations of DTG and RPV at Weeks 56, 76 and 100 in Participants Switching to DTG+RPV-CAR Late Switch Group Through Late Switch Phase|Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 56, 76, and 100. Pre-dose concentrations of DTG and RPV at Weeks 56, 76 and 100 is summarized for the participants switching to DTG + RPV in the late switch phase. LS PK Parameter Population comprised of all participants who were randomized to CAR and received DTG + RPV in the Late Switch Phase and provided at least one evaluable estimate of Pre-dose concentration.|Pre-dose at Weeks 56, 76 and 100|LS PK Parameter Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||ug/ L||Standard Deviation|Mean
2578423|NCT02429791|Secondary|Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV-DTG+RPV Early Switch Group Through Early and Late Switch Phase|Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 4, 24, 48, 56, 76, and 100. Pre-dose concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 is summarized for the participants switching to DTG + RPV in the early + late switch phase. Pharmacokinetic (PK) Parameter Population consisted of all participants who received DTG +RPV and provided at least one evaluable estimate of predose concentration (C0).|Pre-dose at Week 4, 24, 48, 56, 76 and 100|PK Parameter Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||ug/ L||Standard Deviation|Mean
2578424|NCT02429791|Secondary|Number of Participants With Phenotypic Resistance-CAR Late Switch Group Through Late Switch Phase|Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented.|Post-LS Baseline (Week 52) up to Week 148|LS CVW resistance Population. Only those participants with data available at the specified time point were analyzed.|||Participants|||Count of Participants
2578425|NCT02429791|Secondary|Number of Participants With Phenotypic Resistance-DTG+RPV Early Switch Group Through Early and Late Switch Phase|Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented.|Up to Week 148|CVW resistance Population|||Participants|||Count of Participants
2578426|NCT02429791|Secondary|Number of Participants With Phenotypic Resistance-Early Switch Phase|Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, RAL, EVG, RPV, ETR, 3TC, ABC, FTC, TDF, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented.|Up to Week 48|CVW resistance Population|||Participants|||Count of Participants
2578427|NCT02429791|Secondary|Number of Participants With Genotypic Resistance-CAR Late Switch Group Through Late Switch Phase|Plasma samples were collected for drug resistance testing. Late Switch (LS) CVW resistance Population comprised of all participants in the LS-ITT-E Population who met CVW through the end of visit window (Week 48, Week 100 or Week 148) and had available on-treatment genotypic resistance data at the time CVW criterion was met. Genotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented.|Post-LS Baseline (Week 52) up to Week 148|LS CVW resistance Population. Only those participants with data available at the specified time point were analyzed.|||Participants|||Count of Participants
2578428|NCT02429791|Secondary|Number of Participants With Genotypic Resistance-DTG+RPV Early Switch Group Through Early and Late Switch Phase|Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (DTG, Elvitegravir [EVG], Raltegravir [RAL], Delavirdine [DLV], Efavirenz [EFV], Etravirine [ETR], Nevirapine [NVP], RPV, Lamivudine [3TC], Abacavir [ABC], FTC, TDF, Zidovudine [ZDV], Stavudine [d4T], Didanosine [ddI], Atazanavir/r [ATV/r], DRV/r, Fosamprenavir/r [FPV/r], Indinavir/r [IDV/r], Lopinavir/r [LPV/r], Nelfinavir [NFV], Ritonavir [RTV], Saquinavir/r [SQV/r], Tipranavir/r [TPV/r]) in participants Meeting CVW Criteria has been presented.|Up to Week 148|CVW resistance Population|||Participants|||Count of Participants
2578429|NCT02429791|Secondary|Number of Participants With Genotypic Resistance- Early Switch Phase|Plasma samples were collected for drug resistance testing. Confirmed Virologic Withdrawal (CVW) resistance Population comprised of all participants in the ITT-E Population who met confirmed CVW through the end of visit window (Week 48, Week 100 or Week 148) and had available on-treatment genotypic resistance data at the time CVW criterion was met. Genotypic Resistance data for the following drugs (Rilpivirine [RPV], Dolutegravir [DTG], Emtricitabine [FTC], Tenofovir [TDF], Darunavir/r [DRV/r]) in participants Meeting CVW Criteria has been presented.|Up to Week 48|CVW Resistance Population|||Participants|||Count of Participants
2578430|NCT02429791|Secondary|Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48|Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1), Week 24 and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||mmol/ L||Standard Deviation|Mean
2578431|NCT02429791|Secondary|Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess insulin resistance. Change from Baseline was calculated as value at indicated time point minus Baseline value. The homeostatic model assessment (HOMA) of insulin resistance (HOMA-IR) index, the product of basal glucose and insulin levels divided by 22.5 (1,2), is regarded as a simple, inexpensive, and reliable surrogate measure of insulin resistance.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed|||HOMA-IR Score||Standard Deviation|Mean
2578432|NCT02429791|Secondary|Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess IL-6. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time point were analyzed.|||Nanograms (ng)/ L||Standard Deviation|Mean
2578433|NCT02429791|Secondary|Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type I Collagen C-Telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess bone-specific alkaline phosphatase, procollagen 1 N-terminal propeptide, osteocalcin, Type I Collagen C-Telopeptides and sVCAM. Change from Baseline was calculated as value at indicated time point minus Baseline value. For bone-specific alkaline phosphatase, procollagen 1-N-propeptide, osteocalcin and type 1 collagen C-telopeptide, analyses of changes from baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||ug/ L||Standard Deviation|Mean
2578434|NCT02429791|Secondary|Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48|Urine biomarker samples were collected at Baseline (Day 1) and Week 48 to assess urine albumin/creatinine ratio and urine protein/creatinine ratio. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Grams (g)/ mol||Standard Deviation|Mean
2578435|NCT02429791|Secondary|Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess B2M and 25 hydroxy-vitamin D. Urine samples were collected to assess B2M and RBP. Change from Baseline was calculated as value at indicated time point minus Baseline value. For 25 hydroxy-vitamin D, analysis of changes from Baseline was performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Nanomoles/ L||Standard Deviation|Mean
2578436|NCT02429791|Secondary|Mean Change From Baseline in Urine Phosphate at Week 48|Urine biomarker samples were collected at Baseline (Day 1) and Week 48 to assess urine phosphate. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Millimoles (mmol)/ L||Standard Deviation|Mean
2578437|NCT02429791|Secondary|Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess RBP, serum creatinine and glucose. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||mg/deciliter (dL)||Standard Deviation|Mean
2578438|NCT02429791|Secondary|Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess soluble CD163 and oxidized LDL. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Microgram (ug)/Liter||Standard Deviation|Mean
2578439|NCT02429791|Secondary|Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess FABP and soluble CD14. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Nanogram/milliliter||Standard Deviation|Mean
2578440|NCT02429791|Secondary|Mean Change From Baseline in D-Dimer at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess D-Dimer. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Nanomole/L fibrinogen equivalent units||Standard Deviation|Mean
2578441|NCT02429791|Secondary|Mean Change From Baseline in Cystatin C at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess cystatin C. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed.|||mg/L||Standard Deviation|Mean
2578442|NCT02429791|Secondary|Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess hs-CRP. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed.|||mg/ Liter (L)||Standard Deviation|Mean
2578443|NCT02429791|Secondary|Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities Over 48 Weeks|Blood samples were collected to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, mean corpuscular volume (MCV), red blood cell (RBC) count, white blood cell (WBC) count and platelet count. Value obtained at Day 1 was considered as Baseline value. Number of participants who experienced maximum grade toxicity post-Baseline in hematology over 48 weeks was summarized. Hematology toxicities were graded using DAIDS grading table for grading severity of adult and pediatric adverse events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a hematology toxicity.|Up to 48 weeks|Safety Population|||Participants|||Count of Participants
2578456|NCT02429583|Secondary|Functional Response of Monocytes Stimulated ex Vivo With Vaccine Antigen and/or Adjuvant|Isolated from patient PBMCs measured at 8 months|8 months|The data was not collected and the analysis was not completed for this study due to insufficient enrollment.||||||
2578457|NCT02429583|Secondary|"Frequency and Functional Status of HBsAg-specific CD4+ Helper T Cells"|Flow cytometry assays measured at 8 months|8 months|The data was not collected and the analysis was not completed for this study due to insufficient enrollment.||||||
2578444|NCT02429791|Secondary|Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities Over 48 Weeks|Blood samples were collected to evaluate alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, blood urea nitrogen (BUN), total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Value obtained at Day 1 was considered as Baseline value. Number of participants who experienced maximum grade toxicity post-Baseline in clinical chemistry over 48 weeks was summarized. Clinical chemistry toxicities were graded using DAIDS grading table for grading severity of adult and pediatric adverse events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a chemistry toxicity.|Up to 48 weeks|Safety Population|||Participants|||Count of Participants
2578445|NCT02429791|Secondary|Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize participant or may require medical or surgical intervention were categorized as SAE. AEs were graded as per Division of Acquired Immunodeficiency Syndrome (DAIDS) grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. Common AEs were those with >5% incidence for either treatment. This summary presents results as reported after all participants completed the Early Switch Phase.|Up to Week 52|Safety Population included all randomized participants who have received at least one dose of study drug.|||Participants|||Count of Participants
2578446|NCT02429791|Secondary|Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm|Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity of DTG + RPV once daily compared to continuation of CAR. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA.|Week 24|ITT-E Population|||Percentage of participants|||Number
2578447|NCT02429791|Secondary|Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48|Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunological activity of DTG + RPV once daily compared to continuation of CAR. Value obtained at Day 1 was considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1), Weeks 24 and 48|ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Cells per millimeter cube (mm^3)||Standard Deviation|Mean
2578448|NCT02429791|Primary|Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm|Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior antiviral activity of switching to DTG + RPV once daily compared to continuation of CAR over 48 weeks in HIV-1 infected antiretroviral therapy (ART)-experienced participants. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA. The Intent-to-Treat Exposed (ITT-E) population consisted of all randomly assigned participants who received at least one dose of study drug.|Week 48|ITT-E Population|||Percentage of participants|||Number
2578449|NCT02429778|Other Pre-specified|Change in Blood Pressure|Blood pressure will be measured at baseline and at 8 weeks after enrollment. This is an exploratory measure.|Change from baseline to 8 weeks|||||||
2578450|NCT02429778|Other Pre-specified|Change in Heart Rate|Heart rate will be measured at baseline and at 8 weeks after enrollment. This is an exploratory measure.|Change from baseline to 8 weeks|||||||
2578451|NCT02429778|Secondary|Change in Somatic Symptoms|Somatic Symptom Scale (SSS-8). The SSS-8 is an 8-item somatic symptom assessment rated on a five-point Likert-type scale with scores ranging from 0 to 32. The SSS-8 is administered to characterize participants' somatic symptoms. Higher symptoms indicate worse somatic symptom severity.|Change from baseline to 8 weeks|A linear mixed effects model using maximum likelihood modeling was employed to analyze these data using intent-to-treat principles.|||units on a scale||Standard Error|Mean
2578452|NCT02429778|Secondary|Change in Depressive Symptoms|The Patient Health Questionnaire 9-item (PHQ-9) is a 9-item depression assessment rated on a four-point Likert-type scale with scores ranging from 0 to 27. It includes one item that inquires about suicide ideation. Higher scores indicate more severe depressive symptoms. Validity and reliability have been established with primary care patients.|Change from baseline to 8 weeks|A linear mixed effects model using maximum likelihood modeling was employed to analyze these data using intent-to-treat principles.|||units on a scale||Standard Error|Mean
2578453|NCT02429778|Primary|Change in Activity Engagement|The Activity Card Sort contains 80 photographs that depict the performance of instrumental activities, low-physical-demand leisure activities, high-physical-demand leisure activities, and social activities. This measure will be used to assess engagement in activities. The score reported is the lifestyle-adjusted function score. It represents the percentage of activities ever completed that are perceived to be easy. Higher scores indicate greater ease of activity completion/engagement.|Change from baseline to 8 weeks|A linear mixed effects model using maximum likelihood modeling was employed to analyze these data using intent-to-treat principles.|||units on a scale||Standard Error|Mean
2578454|NCT02429778|Primary|Change in Anxiety Symptoms|The Geriatric Anxiety Scale (GAS) is a 30-item measure of somatic, cognitive, and affective symptoms of anxiety. The first 25 items of the measure are used to compute the total score; the last 5 items provide information about the content of worries or fears. Total scores range from 0 to 75 with higher scores indicating worse anxiety. Participants provide severity ratings for items using on a four-point Likert-type scale.|Change from baseline to 8 weeks|A linear mixed effects model using maximum likelihood modeling was employed to analyze these data using intent-to-treat principles.|||score on a scale||Standard Error|Mean
2578459|NCT02429583|Primary|HBV Vaccine Response Versus Non-response Status|"Titers of anti-hepatitis B surface antigen antibody measured at 8 months~Luminex assay for multiplex cytokine/chemokine panel measured at 8 months RNA-Seq with analysis focus on curated ISG list measured at 8 months"|8 months|The data was not collected and the analysis was not completed for this study due to insufficient enrollment.||||||
2578460|NCT02429310|Secondary|Serum Metabolic Profile|A serum sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out.|Change of profile at baseline and 6 weeks|||||||
2578461|NCT02429310|Secondary|Urine Metabolic Profile|A urine sample will be collected at baseline and at 6 weeks. Mass spectroscopy and nuclear magnetic resonance spectroscopy analysis will be carried out.|Change of profile at baseline and at 6 weeks|||||||
2578462|NCT02429310|Secondary|Quality of Life Scores Measured by Questionnaire|Validated questionnaires including the Euro-Quol 5D and Short Form 36 will be measured at baseline and 6 weeks.|Change in baseline quality of life at 6 weeks|||||||
2578463|NCT02429310|Secondary|Symptomatic Scores by Questionnaire|Validated questionnaires including the Edinburgh Claudication Questionnaire and Intermittent Claudication Questionnaire will be obtained at baseline and week 6.|Change in baseline questionnaire scores at 6 weeks|||||||
2578464|NCT02429310|Secondary|Laser Doppler Flow Measured by Optical Laser|Optical laser flowmetry probes will be used to assess the superficial skin circulation and temperature.|Change in baseline flowmetry at 6 weeks|||||||
2578465|NCT02429310|Secondary|Femoral Haemodynamics Measured by Femoral Artery Duplex Ultrasonography|Ultrasound assessment of blood flow dynamics in the femoral artery will be obtained at rest, and if randomised to the intervention group, whilst using the device.|Change in baseline femoral haemodynamics at 6 weeks|||||||
2578466|NCT02429310|Primary|Absolute Walking Distance Measured by Treadmill|For the absolute claudication distance measurement, a fixed load treadmill test will be carried out at 3.5 km/h with a 10% gradient. The absolute claudication distance (ACD) is the distance walked before the participant is forced to stop due to typical pain.|Change in baseline treadmill walking distance at 6 weeks||||metres||Inter-Quartile Range|Median
2578467|NCT02429310|Primary|Initial Walking Distance Measured by Treadmill|For the initial claudication distance measurement, a fixed load treadmill test will be carried out at 3.5 km/h with a 10% gradient. The initial claudication distance (ICD) is the distance walked until the onset of pain.|Change in baseline treadmill walking distance at 6 weeks||||metres||Inter-Quartile Range|Median
2578468|NCT02429258|Secondary|Change in Static Insulin Secretion Rate (10^-9 Min^-1) From Baseline to Week 4 - ITT Population||Baseline to Week 4||||10^-9 min^-1||Standard Error|Least Squares Mean
2578469|NCT02429258|Secondary|Change in 2-hour Mean Weighted PPG (After the Standardized Breakfast Meal) From Baseline to Week 4||Baseline to Week 4||||mg/dL||Standard Error|Least Squares Mean
2578470|NCT02429258|Secondary|Change in Fructosamine From Baseline to Week 4||Baseline to Week 4||||mmol/L||Standard Error|Least Squares Mean
2578471|NCT02429258|Secondary|Change in HbA1c From Baseline to Week 4||Baseline to Week 4||||% Alc||Standard Error|Least Squares Mean
2578472|NCT02429258|Secondary|Change in 4-hour Mean Weighted Post-prandial Glucose (PPG) (After the Standardized Breakfast Meal) From Baseline to Week 4||Baseline to Week 4||||mg/dL||Standard Error|Least Squares Mean
2578473|NCT02429258|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 4||Baseline to Week 4||||mg/dL||Standard Error|Least Squares Mean
2578474|NCT02429258|Secondary|Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose >180 mg/dL From Baseline to Week 4 - ITT Population||Baseline to Week 4||||Change in percentage||Standard Error|Least Squares Mean
2578475|NCT02429258|Secondary|Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose Between 70 mg/dL and 180 mg/dL From Baseline to Week 4 - ITT Population||Baseline to Week 4||||Change in percentage||Standard Error|Least Squares Mean
2578476|NCT02429258|Secondary|Change in Percentage of CGM Readings Over 24-hours With Plasma Glucose <70 mg/dL From Baseline to Week 4 - ITT Population||Baseline to Week 4||||Change in percentage||Standard Error|Least Squares Mean
2578477|NCT02429258|Secondary|Change in the 24-hour Mean Ampitude of Glucose Excursions (MAGE) From Baseline to Week 4||Baseline to Week 4||||mg/dL||Standard Error|Least Squares Mean
2578478|NCT02429258|Primary|Change in 24-hour Mean Weighted Glucose (MWG) From Baseline to End of Treatment (Week 4) Using the Continuous Glucose Monitoring (CGM) System||Baseline to Week 4||||mg/dL||Standard Error|Least Squares Mean
2578479|NCT02429115|Secondary|Slope of Change in Patient Activation Measure (PAM)|The Patient Activation Measure (PAM) is the secondary outcome measure. The score ranges between 0-100. Higher scores represent improved patient activation and lower numbers indicate less patient activation. Change in the PAM is the outcome variable of interest. We computed the slopes ( rate of change in the PAM score from baseline to 12 months and 18 months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different among the study groups using t-test.|Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported.|Patient participants|||Scores on a scale / Months||95% Confidence Interval|Number
2578480|NCT02429115|Primary|Slope of Change in Zarit Caregiver Burden Interview (ZBI) Score|"The Zarit caregiver Burden Interview (ZBI) score is the primary outcome measure. The score ranges between 0 and 88. Higher scores represent increased caregiver burden (worse outcome); smaller numbers indicate less caregiver burden (better outcome).~Change in the ZBI score is the outcome variable of interest. We computed the slopes (rates of change in ZBI from baseline to 12 months and 18 months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using t-test."|Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported.|Caregivers of patients with CKD|||Scores on a scale / Months||95% Confidence Interval|Number
2578515|NCT02428309|Secondary|Change From Baseline in mm/hr: Sedimentation Rate (ESR)|Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values.|Baseline (Visit 0) and Weeks 4, 12, 48, and 152|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||mm/hr||Standard Deviation|Mean
2578481|NCT02429115|Primary|Slope of Change in Kidney Disease Quality of Life-36 Score|The Kidney Disease Quality of Life-36 (KDQOL-36) score is the primary outcome measure. The KDQOL-36 contains 5 subscales: the Physical Component Summary (PCS), Mental Component Summary (MCS), Burden of Kidney Disease (BKD), Symptoms and Problems of Kidney Disease (SPKD), and Effects of Kidney Disease (EKD). The range for the sore of each domain is 0-100. Higher scores represent improved Quality of Life. Change in the scores of components of the KDQOL is the outcome variable of interest. We computed the slopes (rates of change in KDQOL subscales from baseline to 12 months and 18 months) using a random effects ANOVA (random intercept and random slope), and determined if the slopes were different using t-test.|Measured at baseline, at 12 months and at 18 months, slope of change at 18 months reported.|Patient participants.|||Scores on a scale / Months||95% Confidence Interval|Number
2578482|NCT02428699|Secondary|Tmax of Sum of Total and Free EPA|Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h.Time to maximum concentration was determined.|Baseline and up to Day 2|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||h||Standard Deviation|Mean
2578483|NCT02428699|Secondary|Tmax of Sum of Total and Free DHA|Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h. Time to maximum concentration was determined.|Baseline and up to Day 2|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||h||Standard Deviation|Mean
2578484|NCT02428699|Secondary|Time to Maximum Concentration (Tmax) of Sum of Total and Free DHA and EPA|Blood samples will be taken at time points 0,2,4,6,8,10,12 and 24h. Time to maximum concentration was determined.|Baseline and up to Day 2|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||h||Standard Deviation|Mean
2578485|NCT02428699|Secondary|Cmax of Sum of Total and Free EPA|Blood sampleswere taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined.|Baseline and up to Day 2|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||µg/mL||Standard Deviation|Mean
2578486|NCT02428699|Secondary|Cmax of Sum of Total and Free DHA|Blood samples were taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined.|Baseline and up to Day 2|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||µg/mL||Standard Deviation|Mean
2578487|NCT02428699|Secondary|Maximum Concentration (Cmax) of Sum of Total and Free DHA and EPA|Blood sampleswere taken at time points 0,2,4,6,8,10,12 and 24h. Maximum plasma concentration was determined.|Baseline and up to Day 2|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||µg/mL||Standard Deviation|Mean
2578488|NCT02428699|Secondary|iAUC0-10h of Sum of Total and Free DHA and EPA|The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, and 10h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values.|Upto 10 h|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||µg/mL||Standard Deviation|Mean
2578489|NCT02428699|Secondary|iAUC0-10h of Sum of Total and Free EPA|The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, and 10h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values.|Upto 10 h|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||µg/mL||Standard Deviation|Mean
2578490|NCT02428699|Secondary|iAUC0-10h of Sum of Total and Free DHA|The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, and 10h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values.|Upto 10 h|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||µg/mL||Standard Deviation|Mean
2578491|NCT02428699|Secondary|iAUC0-24h of Sum of Total and Free EPA|The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, 10, 12 and 24 h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values.|Baseline and up to Day 2|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||µg/mL||Standard Deviation|Mean
2596888|NCT02203630|Secondary|Number of Participants With Cardiac Arrest Events||Up to 28 days||||Participants|||Count of Participants
2578492|NCT02428699|Secondary|iAUC0-24h of Sum of Total and Free DHA|The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, 10, 12 and 24 h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values.|Baseline and up to Day 2|PP population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||µg/mL||Standard Deviation|Mean
2578493|NCT02428699|Primary|Incremental Area Under the Curve to 24 Hours (h) (iAUC0-24h) of the Sum of Plasma Total and Free n-3 Fatty Acids (Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA)|The AUC was calculated using the trapezoidal method and using nominal time points from 0, 2, 4, 6, 8, 10, 12 and 24 h respectively. The AUC was divided by the total duration to represent a weighted mean incremental change over time. Higher values of AUC demonstrate better rate of absorption over time than lower values.|Baseline and up to Day 2|Per protocol (PP) population (N=47) was the primary population of analysis defined as all participants in the safety population who have at least one post-baseline assessment of efficacy considered unaffected by protocol violations. From the PP population, 3 participants were not analysed in test group and 2 in control group, due to missing data.|||Microgram per mililiter (µg/mL)||Standard Deviation|Mean
2578494|NCT02428608|Other Pre-specified|Change From Baseline Glabellar Line Scale (GLS) Score at Rest and at Maximum Frown|Proportion of subjects with an improvement of 1 point or more (i.e., ≥1 point responders) on the GLS at rest at end of study/early termination: by Investigator assessment|365 days|By Investigator assessment, 500 subjects had a GLS score at rest >0 (i.e., 1, 2 or 3) at baseline and therefore could potentially have had a ≥1 point improvement in GLS score at rest at a post-baseline visit; 64 subjects were missing the EOS GLS assessment|||Participants|||Count of Participants
2578495|NCT02428608|Primary|The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year|The primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365.|365 days||||Participants|||Count of Participants
2578496|NCT02428595|Other Pre-specified|Safety Endpoint - Number of Device Related Adverse Events|"The number of device-related adverse events and device-related serious adverse events (related defined as probably or definitely).~Events are classified as occurring either during fitting (the process of identifying the correct size of the device) or during treatment (defined as the time when a patient receives their long term wear device until the completion of the study)."|3, 6, 9 and 12 months||||Count of Adverse Events|||Number
2578497|NCT02428595|Secondary|Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores|"The Patient Global Impression of Improvement (PGI-I) is a scale which describes the patient's perception of how their symptoms have change from Baseline.~The scale has a range of 7 points from 1 to 7, where 1 = very much better than Baseline and 7 = very much worse than Baseline and 4 = no change from Baseline. A score below 4 is a better outcome and a score above 4 is a worse outcome, and a score of 4 is a neutral outcome.~Note that because the patient is being asked to compare their symptoms to Baseline, no data is taken for this scale at Baseline and the score is an absolute value, not a change from a previous score."|3, 6, 9 and 12 months||||Participants|||Count of Participants
2578498|NCT02428595|Secondary|Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline|"Change in mean score (from Baseline) on subject-reported outcomes as reported by FIQoL (Fecal Incontinence Quality of Life) score.~The FIQoL scale asks a number of Fecal Incontinence (FI) related questions. Patient responses are rated from 1 to 4 points except one question which is rated from 1 to 5 points.~The questions fall into four subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. The score for each subscale is the average of the responses in that group. For depression/self-perception the subscale score is from 1.0 to 5.0. The other subscale scores are from 1.0 to 4.0.~The total FIQoL score is the sum of all four subscales, ranging from 4 to 17. For each subscale and the combined score, lower values indicate worse quality of life and higher values indicate better quality of life.~An increase in score as compared to Baseline is therefore a better outcome."|12 months||||Score on a scale||Standard Deviation|Mean
2578499|NCT02428595|Secondary|Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline|"Change in mean scores on subject-reported outcomes related to symptom severity as reported by St. Mark's (Vaizey) Incontinence Severity Score.~St. Mark's is a validated scale widely used in fecal incontinence research. The scale has a 24 point range where 0 = total fecal continence (better outcome) and 24 = total fecal incontinence (worse outcome). A reduction in the St. Mark's score is a better outcome."|12 months||||Score on a Scale||Standard Deviation|Mean
2578500|NCT02428595|Secondary|Count of Treatment Responders in the Per Protocol (PP) Population|Count of patients with >50% reduction in the average number of FI episodes per week as compared to Baseline.|3, 6 and 12 months||||Participants|||Count of Participants
2578501|NCT02428595|Primary|Count of Treatment Responders in the Intent to Treat (ITT) Cohort|Count of patients with >50% reduction in the average number of FI episodes per week as compared to baseline.|3 months||||Participants|||Count of Participants
2578502|NCT02428478|Secondary|Change in Pharyngeal Critical Collapsing Pressure (Pcrit) as a Measure of Upper Airway Collapsibility|Participants were connected to a modified continuous positive airway pressure (CPAP) machine (Pcrit3000, Respironics) which provided a wide range of pressures between 20 and -20 cm H2O in order to modify upper airway pressure. Following a baseline recording period of 5 minutes, the CPAP level was reduced to varying suboptimal pressures. Change in Pcrit was used to determine the collapsibility of the upper airway under both passive and active conditions, and is expressed as Passive Pcrit: ventilation at a nasal pressure of 0 cm H2O when pharyngeal muscles are passive; Active Pcrit: ventilation at a nasal pressure of 0 cm H2O when pharyngeal muscles are active. Improved=more negative Pcrit.|1 night|All participants who were randomized, completed both study nights, and were included in the analysis. 4 participants were excluded: 3 due to intermittent electromyographic amplifier malfunction; and 1 did not sleep on both study nights.|||cm H2O||Inter-Quartile Range|Median
2578622|NCT02426125|Secondary|PK: Minimum Concentration (Cmin) of Ramucirumab|Minimum concentration (Cmin) of Ramucirumab following administration every 3 weeks.|Day 1 of Cycle 2, 3, 5 and 9 (Predose and Postdose)|The first randomized participants who had evaluable PK data.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2578503|NCT02428478|Primary|Genioglossus Activity During Non-rapid Eye Movement (NREM) Sleep Measured as Percent of Wakefulness Activity|Electromyography (EMG) was used to analyze genioglossus (GG) [EMG GG] muscle movement. EMG GG activity was recorded via standard needle electrodes inserted into the genioglossus (tongue) muscle. Activity of EMG GG was measured during wakefulness and sleep as % of maximum activation obtained pushing the tongue against closed teeth during wakefulness (GG%max). Sleep values were then expressed as %wakefulness value for tonic and phasic EMG GG activity. Tonic activity was defined as the lowest EMG GG value during expiration, phasic activity was calculated as the peak value during inspiration minus the tonic value.|1 night|All participants who were randomized, completed both study nights, and were included in the analysis. 4 participants were excluded: 3 due to intermittent electromyographic amplifier malfunction; and 1 did not sleep on both study nights.|||percent wakefulness||Inter-Quartile Range|Median
2578504|NCT02428413|Primary|Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Duration|For MAX-WAG measurements obtained every 30 seconds, we calculated the duration of MAX-WAG [>2ppm]|1 hour post-operative recovery period||||minutes||Inter-Quartile Range|Median
2578505|NCT02428413|Primary|Efficacy of the ISO-Gard Mask in Reducing Caregiver's Exposure to WAG-Percentage of Time|For MAX-WAG measurements obtained every 30 seconds, we calculated the percentage of time in MAX-WAG [>2ppm] relative to the total collection period.|1 hour post-operative recovery period||||percentage of time||Inter-Quartile Range|Median
2578506|NCT02428413|Primary|Waste Anesthetic Gas Measured by Parts Per Million Emanating From Patients During Normal PACU Working Conditions|The measurement of Waste Anesthetic Gas in parts per million emanating from the patient between the standard oxygen mask and the ISO-Gard oxygen mask.|1 hour post-operative recovery period||||parts per million||Standard Deviation|Mean
2578507|NCT02428413|Primary|Waste Anesthetic Gas Measured by Parts Per Million Within PACU Caregiver's Breathing Zone With Caring for Patients|The measurement of Waste Anesthetic Gas in parts per million resolution emanating from the patient to the caregiver's breathing zone.|1 hour post-operative recovery period|A study size of 100 randomized subjects will be used. Aforementioned sample size was determined to be able to detect an effect size of 0.57 that would provide 80% power and 5% type I error (95% confidence interval and p-0.05 level of significance). Two sample student t-test will be used to do data analysis.|||parts per million||Standard Deviation|Mean
2578508|NCT02428309|Secondary|Change From Baseline in Serum C4 Complement Levels|C4 is a blood test that measures the activity of the complement component 4 (C4) protein. The normal range is 13 to 30 mg/dL. Individuals with active systemic lupus erythematosus (SLE) may have a lower-than-normal level of C4. A decrease in C4 level over time may indicate disease activity.|Baseline (Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||mg/dL||Standard Deviation|Mean
2578509|NCT02428309|Secondary|Change From Baseline in Serum C3 Complement Levels|C3 is a blood test that measures the activity of the complement component 3 (C3) protein. The normal C3 range is 71 to 159 mg/dL. Those with active systemic lupus erythematosus (SLE) may have a lower-than-normal level of C3. A decrease in C3 level over time may indicate SLE disease activity.|Baseline (Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||mg/dL||Standard Deviation|Mean
2578510|NCT02428309|Secondary|Change From Baseline in Anti-dsDNA Antibody Titers|Double-stranded DNA is one of multiple diagnostic tests for SLE and high levels may be associated with disease activity. The positive range is based on the normal range from the local laboratory. A positive change from baseline value indicates the detection of autoantibodies to double-stranded DNA.|Baseline ( Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||IU/mL||Standard Deviation|Mean
2578511|NCT02428309|Secondary|Change From Baseline in Physician's Global Assessment (PhGA)|The physician's global assessment (PhGA) is a visual analog 3-inch scale in the SELENA-SLEDAI that is scored from 0 to 3 by the physician. A score of 0 corresponds to no lupus disease activity and a score of 3 corresponds to severe disease activity. A positive change from baseline indicates more disease activity.|Baseline (Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||inches||Standard Deviation|Mean
2578512|NCT02428309|Secondary|Change From Baseline in Patient's Global Assessment (PGA)|The global assessment (PGA) is a visual 3-inch analog scale from 0 to 3 in which the participant marks the scale according to perceived disease activity. A score of 0 corresponds to no lupus disease activity and a score of 3 corresponds to severe disease activity. A positive change from baseline indicates more disease activity.|Baseline (Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||inches||Standard Deviation|Mean
2578513|NCT02428309|Secondary|Change From Baseline in SELENA-SLEDAI Total Score|The Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus (SLE) Disease Activity Index (SELENA-SLEDAI) score is a weighted scale score ranging from 0 to 105 based on the presence or absence of 24 manifestations of SLE. The SELENA-SLEDAI assesses disease activity for 10 days prior to and including the day of assessment. Positive change in the SELENA-SLEDAI score indicates increased disease activity.|Baseline (Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||units on a scale||Standard Deviation|Mean
2578514|NCT02428309|Secondary|Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score|The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated, physician-based assessment tool used to measure cutaneous lupus severity. Severity is calculated based on disease activity (erythema and scale) and damage (dyspigmentation and scarring) for the cumulative areas of involved skin. Severity categories based on the CLASI activity score are as follows: mild (0-9), moderate (10-20), and severe (21-70). A 4-point or 20% change in the CLASI activity score identifies a clinically meaningful change. A 4-point increase in the CLASI activity score indicates a flare.|Baseline (Visit 0) and Weeks 12, 24, 36, 48, 100, 126, and 152|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||units on a scale||Standard Deviation|Mean
2578516|NCT02428309|Secondary|Change From Baseline Red Blood Cell Count|Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values.|Baseline (Visit 0) and Weeks 4, 12, 48, and 152|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||Cell Count x10^12/L||Standard Deviation|Mean
2578517|NCT02428309|Secondary|Change From Baseline in Cell Counts: White Blood Cells (WBC), Total Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelets|Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values.|Baseline (Visit 0) and Weeks 4, 12, 48, and 152|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||Cell Count X 10^9/L||Standard Deviation|Mean
2578518|NCT02428309|Secondary|Change From Baseline in mmol/L: Potassium, Sodium, Chloride|Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values.|Baseline (Visit 0) and Weeks 4, 12, 48, and 152|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||mmol/L||Standard Deviation|Mean
2578519|NCT02428309|Secondary|Change From Baseline in mg/dL: Total Bilirubin, Creatinine|Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values.|Baseline (Visit 0) and Weeks 4, 12, 48, and 152|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||mg/dL||Standard Deviation|Median
2578520|NCT02428309|Secondary|Change From Baseline in g/dL: Albumin, Hemoglobin|Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values depend on a subject age, gender, and the specific laboratory methods that were used to determine the lab values.|Baseline (Visit 0) and Weeks 4, 12, 48, and 152|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||g/dL||Standard Deviation|Mean
2578521|NCT02428309|Secondary|Change From Baseline: Alkaline Phosphatase (ALK), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST)|Change=Post Baseline value minus Baseline value. A positive difference reflects an increased laboratory parameter value over time; a negative difference reflects a decreased laboratory parameter value over time. Normal laboratory values are based on subject age, gender, and the specific laboratory methods that were used to determine the lab values.|Baseline (Visit 0) and Weeks 4, 12, 48, and 152|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||U/L||Standard Deviation|Mean
2578522|NCT02428309|Secondary|Number Infusion-Related Adverse Events (AEs) Within 24 Hours of Infusion|Any infusion-related adverse events Grade 1 or higher within 24 hours of polyclonal Treg infusion. This study graded the severity of adverse events according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0.|From time of infusion to 24 hours post infusion|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||Events|||Number
2578523|NCT02428309|Secondary|Number of Lupus Flares Through Week 152 by Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) and Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Criteria|An activity score increase of ≥4 CLASI points defines a flare. A mild/moderate flare includes at least one of the following SELENA-SLEDAI criteria: Increase in the SLEDAI Score of ≥3 points, new or worse discoid, photosensitive, profundus, cutaneous vasculitis, bullous lupus, nasopharyngeal ulcers, pleuritic, pericarditis, arthritis, fever attributable to SLE; increase in prednisone (<0.5 mg/kg/day); added NSAID or Plaquenil; increase in PhGA (<2.5 [on a 3.0 indexed VAS scale]). A severe flare includes at least one of the following SELENA-SLEDAI criteria: Increase of >12 in the SLEDAI Score; new or worse CNS-SLE, vasculitis, nephritis, myositis, platelet count <60,000/mm^3, hemolytic anemia with hemoglobin <7% or decrease in hemoglobin >3%; prednisone >0.5 mg/kg/day; new Cyclophosphamide, Azathioprine, Methotrexate, Mycophenolate Mofetil, or hospitalization attributable to SLE; increase in PhGA to >2.5.|From time of signed informed consent to Week 152|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||Flares|||Number
2578524|NCT02428309|Secondary|Number of Infection-Related Adverse Events (AEs) Through Week 152|If the adverse event was believed to be caused by a viral, bacterial, or fungal organism, regardless of whether it was treated with antibiotics or not, then it was classified as infection-related.|From time of signed informed consent to Week 152|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||Events|||Number
2578525|NCT02428309|Secondary|Number of Grade 3 or Higher Adverse Events (AEs) Through Week 152|Adverse events (AEs) Grade 3 or higher were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0.|From time of signed informed consent to Week 152|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||Events|||Number
2578526|NCT02428309|Secondary|Number of Significant Adverse Events (AEs) Through Week 152|A significant adverse event is any related National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0 Grade 3 or higher AE or any related serious adverse event. Related is defined as being possibly, probably, or definitely related to the ex vivo expanded autologous PolyTregs, as determined by the safety review committee.|From time of signed informed consent to Week 152|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||Events|||Number
2578527|NCT02428309|Primary|Number of Significant Adverse Events (AEs) Through Week 48|A significant adverse event is any related National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.0 Grade 3 or higher AE or any related serious adverse event. Related is defined as being possibly, probably, or definitely related to the ex vivo expanded autologous PolyTregs, as determined by the safety review committee.|From time of signed informed consent to Week 48|One participant enrolled in the study that received a single infusion of 1 x 10^8 autologous polyclonal Tregs (ex vivo selected and expanded)|||Events|||Number
2578528|NCT02428296|Secondary|Number of Hospitalizations and Surgical Interventions|Tracked number of hospitalizations and surgical interventions occurring over the course of the run-in and treatment period.|Run-in (0-26 weeks) and treatment (27-52 weeks)||||number of events|||Number
2578529|NCT02428296|Secondary|Additional Measure of Efficacy: Quality of Life Assessment|"The World Health Organization Quality of Life-BREF (WHOQOL-BREF) assessment measures four domains related to quality of life (physical health, psychological, social relationships, and environment) and produces both individual domain scores (0-100) a total score on a 0-100 scale (high scores indicate a better quality of life). This measure was used to assess quality of life of parents on behalf of their children, and adult subjects.~The Pediatric Quality of Life (PedsQL) assessment is scored on a 0-100 scale (high scores indicate a better health related quality of life). This measure was used to assess quality of life of children.~The outcomes are reported as a change in quality of life based on the change in scores from these assessments between baseline (time 0 months) and end of treatment (time 12 months)."|baseline (0 months) and end of treatment (12 months)|Children (N=15) and parents of children (N=19) were administered quality of life questionnaires. Adult subjects (N=9) were also administered quality of life questionnaires, but the scores were reported as individual domain mean scores; health total mean scores were not reported. Total score data for adults was not analyzed or reported.|||mean change in quality of life score||95% Confidence Interval|Mean
2578530|NCT02428296|Secondary|Mean Sirolimus Doses to Achieve the Target Plasma Concentration|To establish optimal sirolimus dosing algorithms for a future RCT.|Between 6 months and 12 months|All patients were analyzed to determine at which dose the patient would reach the target plasma concentration.|||mg/day||95% Confidence Interval|Mean
2578531|NCT02428296|Primary|Percent Change in Unaffected and Affected Fibrofatty Tissue Measured by MRI Scan|"The outcome was measured as a percent change in tissue volume between the treatment period and run-in period.~For volume calculation, IDEAL fat (Dixon sequence) images were visualized using volumetric software (SliceOmatic, TomoVision, Magog, Canada). Morphology segmentation was performed through computation of watershed gradients. Tissues (fat, muscle, bone, and blood vessel) were manually defined and software was used to generate a surrogate of tissue volume using five slices, with manual adjustments where required.~Absolute volumes of affected and unaffected tissue at week 0 (designated X), week 26 (designated Y), and week 52 (designated Z), were compared. Tissue volume changes (week 0-26 and week 26-52) were designated DELTA, and the percent change % Change. Percent change for the untreated period was [100(Y-X/X)], and for the treated period [100(Z-Y/Y)]."|Run-in (0-26 weeks), treatment (26-52 weeks)|Ten MRI series were analyzed. Only six of ten MRI series that were eligible for analysis included both affected and unaffected sites (the remaining only measured affected tissue).|||percentage of tissue volume change||Standard Deviation|Mean
2578532|NCT02428296|Primary|Percent Change in Unaffected and Affected Fibrofatty Tissue Measured by DXA|"The primary outcome measures will use quantitative DXA scan of the affected and unaffected body part (s) to demonstrate negative change in fibrofatty, muscular, and/or bony overgrowth.~Absolute volumes of affected and unaffected tissue at week 0 (designated X), week 26 (designated Y), and week 52 (designated Z), were compared by taking the difference between the mean value obtained during the run-in period and the mean value obtained during the treatment period. Tissue volume changes (week 0-26 and week 26-52) were designated DELTA, and the percent change % Change. Percent change for the untreated period was [100(Y-X/X)], and for the treated period [100(Z-Y/Y)]."|Run-in (0-26 weeks), treatment (26-52 weeks)|The anatomy of 23 patients permitted DXA analysis of affected versus unaffected tissue.|||mean percentage change in tissue volume||Standard Deviation|Mean
2578533|NCT02428231|Secondary|Average Change From Baseline in GSRS Scores to the End of Weeks 4, 6, 8, 10, 12, and 14|Average change from baseline to end of DMF treatment in the GSRS. The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. It was modified for daily recall in this study. GSRS is a rating scale consisting of 15 items for assessment of GI symptoms (see Appendix 1). Items are scored for intensity on a 7-grade Likert scale, defined by descriptive anchors such that 0 = none, 1 = minor, 2 = mild, 3 =moderate, 4 = moderately severe, 5 = severe, and 6 = very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 0 to 6; a score of 0 indicates that no symptoms are present, and a score of 6 indicates the worst possible degree of all symptoms.|Week 2 (Baseline), Weeks 4, 6, 8, 10, 12, 14|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2578534|NCT02428231|Secondary|Time to Recovery to Baseline From Last Occurrence of Worst GSRS Score|The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. It was modified for daily recall in this study. GSRS is a rating scale consisting of 15 items for assessment of GI symptoms (see Appendix 1). Items are scored for intensity on a 7-grade Likert scale, defined by descriptive anchors such that 0 = none, 1 = minor, 2 = mild, 3 =moderate, 4 = moderately severe, 5 = severe, and 6 = very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 0 to 6; a score of 0 indicates that no symptoms are present, and a score of 6 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity.|Week 2 (Baseline), Week 14|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2578547|NCT02427750|Primary|Number of Subjects Reporting Local and Systemic Solicited Adverse Events (AEs) After Receiving One Dose of TIV.|The number of adult and elderly subjects reporting solicited local and systemic AEs and other solicited AEs after receiving one dose of TIV are reported.|Day 1 to Day 4 post vaccination (including 30 mins)|Analysis was done on the solicited safety set population i.e. all subjects who have post vaccination solicited local and systemic adverse event data.|||Number of Subjects|||Number
2578535|NCT02428231|Secondary|Time to First Worsening From Baseline in GSRS Score|The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. It was modified for daily recall in this study. GSRS is a rating scale consisting of 15 items for assessment of GI symptoms (see Appendix 1). Items are scored for intensity on a 7-grade Likert scale, defined by descriptive anchors such that 0 = none, 1 = minor, 2 = mild, 3 =moderate, 4 = moderately severe, 5 = severe, and 6 = very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 0 to 6; a score of 0 indicates that no symptoms are present, and a score of 6 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity.|Week 2 (Baseline), Week 14|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2578536|NCT02428231|Secondary|Average Change From Baseline in GSRS Scores During DMF Treatment|Average change from baseline in GSRS scores over the 12 weeks of DMF treatment as measured by the total change in GSRS scores from baseline divided by the total number of days with GSRS scores recorded. The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. It was modified for daily recall in this study. GSRS is a rating scale consisting of 15 items for assessment of GI symptoms (see Appendix 1). Items are scored for intensity on a 7-grade Likert scale, defined by descriptive anchors such that 0 = none, 1 = minor, 2 = mild, 3 =moderate, 4 = moderately severe, 5 = severe, and 6 = very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 0 to 6; a score of 0 indicates that no symptoms are present, and a score of 6 indicates the worst possible degree of all symptoms.|Week 2 (Baseline), Week 14|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2578537|NCT02428231|Primary|Proportion of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the Gastrointestinal Symptom Rating Scale (GSRS)|The GSRS is a weekly recall scale to rate the severity of GI symptoms in participants. It was modified for daily recall in this study. GSRS is a rating scale consisting of 15 items for assessment of GI symptoms (see Appendix 1). Items are scored for intensity on a 7-grade Likert scale, defined by descriptive anchors such that 0 = none, 1 = minor, 2 = mild, 3 =moderate, 4 = moderately severe, 5 = severe, and 6 = very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 0 to 6; a score of 0 indicates that no symptoms are present, and a score of 6 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity.|from Week 2 (Baseline) to Week 14|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2578538|NCT02427984|Secondary|Number of Participants Who Scored Positive for ALVAL|"Histological score defined by the valuation of staining It was possible to valuate this outcome only for 29 out of 40 patients MoM (due to the availability of periprosthetic tissues).~The arms CoC and controls were not studied for this issue because ALVAL could occur only in presence of Metals"|3 years|positive for ALVAL is +, negative for ALVAL is -|||participants|||Number
2578539|NCT02427984|Primary|Amplitude of Articular Noise Produced During Level Walking|Measured by fast Fourier transform (FFT) expressed in amplitude (decibel) This outcome is valuable only for CoC arm and MoM arm, because Control arm patients don't wear prosthesis (no noise)|3 years||||decibel||Full Range|Mean
2578540|NCT02427984|Primary|Frequency of Articular Noise Produced During Level Walking|Measured by fast Fourier transform (FFT) expressed in frequency (Hz) This outcome is valuable only for CoC arm and MoM arm, because Control arm patients don't wear prosthesis (no noise)|3 years||||Hz||Full Range|Mean
2578541|NCT02427984|Primary|Duration of Articular Noise Produced During Level Walking|"Measured by fast Fourier transform (FFT) expressed in duration (milliseconds)~This outcome is valuable only for CoC arm and MoM arm, because Control arm patients don't wear prosthesis (no noise)"|3 years||||milliseconds||Full Range|Mean
2578542|NCT02427984|Primary|Number of Participants With Chromium and Cobalt Ion Levels Above 7ug/l|"Measured by Inductively coupled plasma mass spectrometry (ICP-MS), equipped with dynamic cell reaction (ELAN DRC II) and expressed in micrograms/liter.~Will be counted the number of patients with level os metals above 7micrograms/liter~This outcome is valuable only for MoM arm and Control arm (as comparison), because CoC arm patients don't wear device releasing this kind of metals."|3 years|the population was evaluated as number of patients with ions level above 7ug/l (attention limit)|||participants above limit|||Number
2578543|NCT02427958|Secondary|Percentage of Participants With Regression or no Progression in Tanner Staging at Week 96|Tanner assessment score was used to document the stage of development of puberty through the assessment of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). Regression or no progression was defined as negative change (improvement) or no change in Tanner score at Week 96 compared to baseline.|Week 96|The full analysis set included all enrolled participants who received at least 1 dose of study drug. The full analysis set where data at specified time points was available.|||percentage of participants||95% Confidence Interval|Number
2578544|NCT02427958|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)||Day 1 up to Week 100|The safety analysis set included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2578545|NCT02427750|Primary|Number of Subjects Reporting Unsolicited AEs After Receiving One Vaccination of TIV.|The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (Day 1 to Day 22), after receiving one vaccination of TIV is reported.|Day 1 to Day 22 post vaccination|Analysis was done on the unsolicited safety set population i.e all subjects who have post vaccination unsolicited adverse event data|||Number of Subjects|||Number
2578546|NCT02427750|Primary|Number of Subjects Reporting Unsolicited AEs After Receiving One Dose of TIV.|The number of subjects in both age groups reporting any unsolicited AEs between Day 1 to Day 4 after receiving one dose of TIV.|Day 1 to Day 4 post vaccination|Analysis was done on the unsolicited safety set population i.e., all subjects who have post vaccination unsolicited adverse event data.|||Number of Subjects|||Number
2578548|NCT02427750|Primary|GMR of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV.|"The antibody responses following one vaccination of TIV were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22/Day 1 post vaccination|The analysis was performed on the PP dataset.|||Ratio||95% Confidence Interval|Geometric Mean
2578549|NCT02427750|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIV.|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIV.~Seroconversion is defined as percentage of subjects with a pre vaccination HI titer <10 and a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 and at least a 4-fold increase in post vaccination HI antibody titers.~The related European (CHMP) criterion for the assessment of immunogenicity is met if >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination HI titers."|Day 22 post vaccination|The analysis was performed on the PP dataset.|||Percentages of Subjects||95% Confidence Interval|Number
2578550|NCT02427750|Primary|Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 and Day 22 post vaccination|The analysis was performed on the PP dataset.|||Percentages of Subjects||95% Confidence Interval|Number
2578551|NCT02427750|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Area (GMAs), After One Dose of TIV.|"The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 in for subjects aged ≥61 years."|Day 22/ Day1 post vaccination|The analysis was performed on the PP dataset.|||Ratio||95% Confidence Interval|Geometric Mean
2578552|NCT02427750|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains, three weeks after receiving one dose of TIV.~Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤ 4mm^2 achieving a post vaccination SRH area ≥ 25mm^2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area > 4mm^2 achieving at least 50% increase in post vaccination SRH area.~The related European (CHMP) criterion for the assessment of immunogenicity is met if >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination SRH areas."|Day 22 post vaccination|The analysis was performed on the PP dataset|||Percentages of subjects||95% Confidence Interval|Number
2578553|NCT02427750|Primary|Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm^2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV.|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm^2 against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European Committee for Medicinal Products for Human Use (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm^2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 and Day 22 post vaccination|The analysis was performed on the per-protocol population (PP).|||Percentages of subjects||95% Confidence Interval|Number
2578554|NCT02427737|Secondary|No-shows (Duke)|Scheduled patients who do not show for their MRI examinations.|9 months (3 months baseline, 6 months post training)|Patients scheduled for MRI scans|||Participants|||Count of Participants
2578555|NCT02427737|Secondary|Disruptive Motion (Duke)|Patients on site who disrupt the scan by motion|9 months (3 months baseline, 6 months post training)|Patients showing for their MRI scans|||Participants|||Count of Participants
2578556|NCT02427737|Secondary|General Anesthesia Rate (Duke)|Number of patients who receive general anesthesia on site|9 months (3 months baseline, 6 months post training)|Patients showing for their MRI scans|||Participants|||Count of Participants
2578557|NCT02427737|Secondary|IV Sedation Rate (Duke)|Number of patients who receive intravenous (IV) sedation on site|9 months (3 months baseline, 6 months post training)|Patients showing for their MRI scans|||Participants|||Count of Participants
2578558|NCT02427737|Secondary|Oral Sedation Rate (Duke)|Patients who receive medical sedation on site|9 months (3 months baseline, 6 months post training)|Patients showing for their MRI scans|||Participants|||Count of Participants
2578559|NCT02427737|Secondary|Patient Satisfaction Ranking in Q3FY16 (OSU)|"Quarterly percentile rankings of patients' Overall Assesment of their satisfaction on a national clinical survey instrument (Press Ganey). Percentile rankings are benchmarked on 1,028 MRI sites nationally, given in raw scores between 0 (worst) to 100 (best). The percentile rankings are based on the number of participants returning surveys in each group."|1 quarter|Number of participants who returned surveys during that quarter.|||National Percentile Satisfaction Ranking||Standard Deviation|Mean
2578560|NCT02427737|Secondary|Patient Satisfaction Ranking in Q2FY16 (OSU)|"Quarterly percentile rankings of patients' Overall Assesment of their satisfaction on a national clinical survey instrument (Press Ganey). Percentile rankings are benchmarked on 1,028 MRI sites nationally, given in raw scores between 0 (worst) to 100 (best). The percentile rankings are based on the number of participants returning surveys in each group."|1 quarter|Number of participants who returned surveys during that quarter.|||National Percentile Satisfaction Ranking||Standard Deviation|Mean
2578617|NCT02426138|Other Pre-specified|Hemoglobin A1c|This will be measured using a fasting blood draw at baseline, 12 and 24 weeks|Measured at end of On-Meals Period and end of Off-Meals Period for each participant|ITT|||% of hemoglobin||Standard Deviation|Mean
2578561|NCT02427737|Secondary|Patient Satisfaction in Q1FY16 (OSU)|"Quarterly percentile rankings of patients' Overall Assesment of their satisfaction on a national clinical survey instrument (Press Ganey). Percentile rankings are benchmarked on 1,028 MRI sites nationally, given in raw scores between 0 (worst) to 100 (best). The percentile rankings are based on the number of participants returning surveys in each group."|1 quarter|Number of participants who returned surveys during that quarter.|||National Percentile Satisfaction Ranking||Standard Deviation|Mean
2578562|NCT02427737|Secondary|Patient Satisfaction Ranking in Q4FY15 = Baseline Quarter (OSU)|"Quarterly percentile rankings of patients' Overall Assesment of their satisfaction on a national clinical survey instrument (Press Ganey). Percentile rankings are benchmarked on 1,028 MRI sites nationally, given in raw scores between 0 (worst) to 100 (best). The percentile rankings are based on the number of participants returning surveys in each group."|1 quarter|Number of participants who returned surveys during that quarter.|||National Satisfaction Ranking||Standard Deviation|Mean
2578563|NCT02427737|Secondary|Trend of No-shows Over All Quarters (OSU)|Quarterly number of scheduled patients who do not show up for their appointments|4 quarters|Patients scheduled for MRI|||Participants|||Count of Participants
2578564|NCT02427737|Secondary|No-shows in Q3FY16 (OSU)|Quarterly number of scheduled patients who do not show up for their appointments|1 quarter|Patients scheduled for MRI|||Participants|||Count of Participants
2578565|NCT02427737|Secondary|No-shows in Q2FY16 (OSU)|Quarterly number of scheduled patients who do not show up for their appointments|1 quarter|Patients scheduled for MRI|||Participants|||Count of Participants
2578566|NCT02427737|Secondary|No-shows in Q1FY16 (OSU)|Quarterly number of scheduled patients who do not show up for their appointments|1 quarter|Patients scheduled for MRI|||Participants|||Count of Participants
2578567|NCT02427737|Secondary|No-shows in Q4FY15 = Baseline Quarter (OSU)|Quarterly number of scheduled patients who do not show up for their appointments|1 quarter|Scheduled patients|||Participants|||Count of Participants
2578568|NCT02427737|Primary|Incompletions (Duke)|Patients who cannot complete their scan|9 months (3 months baseline, 6 months post training)|Patients showing for their MRI scans|||Participants|||Count of Participants
2578569|NCT02427737|Primary|Equipment Utilization Over All Quarters (OSU)|Completion rates of MRIs as a proportion of scans completed per given number of imaging slots available|4 quarters|Imaging slots available|||Proportion of completed scans per slots|Imaging slots||Number
2578570|NCT02427737|Primary|Equipment Utilization in Q3FY16 (OSU)|Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available|1 quarter|Imaging slots available in the quarter|||Proportion of completed scans per slots|Imaging slots||Number
2578571|NCT02427737|Primary|Equipment Utilization in Q2FY16 (OSU)|Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available|1 quarter|Imaging slots available in the quarter|||Proportion of completed scans per slots|Imaging Slots||Number
2578572|NCT02427737|Primary|Equipment Utilization in Q1FY16 (OSU)|Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available|1 quarter|Participants completing their scans|||Proportion of completed scans per slots|Imaging slots||Number
2578573|NCT02427737|Primary|Equipment Utilization Q4FY15 = Baseline Quarter (OSU)|Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available|1 quarter|Imaging slots available in the quarter|||Proportion of completed scans per slots|Imaging slots||Number
2578574|NCT02427672|Primary|Number of Pins Inserted Into a Virtual Voodoo Doll at 24 Hours|The number of pins (between 0 and 51) that participants decide to insert into a picture of a voodoo doll on a computer that represents either a romantic partner or close friend will be recorded on average 24 hours after receiving tDCS or sham stimulation.|On average, 24 hours after the tDCS or sham session||||pins||Standard Error|Mean
2578575|NCT02427672|Primary|Change in Antisocial Behavior Inclinations at 24 Hours|This will be assessed using hypothetical scenarios in which someone commits a criminal or antisocial act. The two brief scenarios describe a physical assault and a sexual assault. Participants will respond to the likelihood that they would commit the act in the scenario according to a 10-point Likert scale. Responses were measured on a scale ranging from zero (no chance at all) to ten (100 percent chance). Scores for both scenarios were summed to obtain an overall measure of intentions to commit aggression. Possible scores range from 0 to 20. A higher value indicates a greater inclination to engage in the antisocial act.|Baseline (an average of 15 minutes before receiving tDCS or sham) and on average, 24 hours following stimulation or sham||||score on a scale||Standard Error|Mean
2578576|NCT02427646|Secondary|Kinematic Tremor Severity|For two subgroups of participants: (A) those with a > 8 point improvement on the tremor rating scale and (B) those with a change ≤ 8 points on the tremor rating scale, Group A will have 50% reduction in overall tremor amplitude as measured by kinematics. Kinematic measures were graphically represented as mean angular RMS amplitude and standard deviations of the population at the wrist over three trials during scripted task. Kinematic tremor analysis is shown in angular root mean square (RMS) amplitudes|96 weeks|Mean kinematic tremor amplitude was compared from baseline to each time-point. Here we state the baseline and final visit tremor amplitudes per group|||Angular root mean square amplitude||Standard Deviation|Mean
2578577|NCT02427646|Primary|Clinical Tremor Rating Scale (Fahn-Tolosa-Marin Tremor Rating Scale)|Improvement in hand tremor as determined by a reduction of >8 points on a standardized clinical assessment tool (Fahn-Tolosa-Marin Tremor Assessment Scale) pre and post Xeomin® injection using kinematic guided injection parameters for both IPD and ET. Lower scores indicate a better outcome. Means and standard deviations are provided in the data tables. FTM minimum and maximum scores range from 0 to 92 FTM points.|0 to 96 weeks|Mean total FTM score was compared from baseline to each time-point. Here we state the baseline and final visit scores per group|||scores on total FTM scale||Standard Deviation|Mean
2578618|NCT02426138|Secondary|Diabetes Distress Scale|Diabetes Distress calculated using the Diabetes Distress Scale Minimum and Maximum scores range of the scale is 17-106 For this measure the lower the score the better|Measured at end of On-Meals Period and end of Off-Meals Period for each participant|ITT|||units on a scale||Standard Deviation|Mean
2578619|NCT02426138|Secondary|Number of Participants With Food Insecurity|Food insecurity is defined as > 2 affirmative responses on the 10 adult referenced items USDA Household Food Security Survey Module|Measured at end of On-Meals Period and end of Off-Meals Period for each participant|ITT|||Participants|||Count of Participants
2578578|NCT02427607|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel|Safety was assessed by monitoring adverse events (AEs), withdrawal from treatment, clinical laboratory tests (chemistry), vital signs, and weight. TEAEs were defined as AEs that emerged from the first dose of study drug to the last visit of Study 341 or on or after 30 days since the last dose of study drug in Study 341, whichever comes later, having been absent at pretreatment (Baseline of Study 332). A markedly abnormal clinical chemistry laboratory value was defined as a laboratory result that worsened in severity to meet modified National Cancer Institute (NCI) toxicity criteria of Grade 2 or higher on treatment. Treatment-related TEAEs were defined as AEs that were considered by the investigator to be possibly or probably related to study treatment. SAEs were defined as any untoward medical occurrence that at any dose; resulted in death, disability/incapacity, birth defect, required inpatient hospitalization or prolongation of existing hospitalization, or was life-threatening.|From first dose of study drug until perampanel was commercially available, up to approximately 1 year 5 months|Safety analysis set included all participants who signed informed consent and received at least one dose of study drug, and had at least one post-dose safety assessment in Study 341.|||Participants|||Number
2578579|NCT02427477|Primary|Subjective Overall Vision|Subjective Overall Vision was evaluated using the Contact Lens User Experience Vison scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|1-week Follow-up|The Analysis population includes subjects that completed all study visits without a major protocol deviation. Due to the study design the number of observations analyzed is larger than the number of participants. This is due to the fact that some subjects wore senofilcon A twice while some subjects wore delefilcon A twice (see Participant Flow).|||units on a scale|Observations|Standard Deviation|Mean
2578580|NCT02427477|Primary|Subjective Overall Comfort|Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|1-week Follow-up|The Analysis population includes subjects that completed all study visits without a major protocol deviation. Due to the study design the number of observations analyzed is larger than the number of participants. This is due to the fact that some subjects wore senofilcon A twice while some subjects wore delefilcon A twice (see Participant Flow).|||units on a scale|Observations|Standard Deviation|Mean
2578581|NCT02427399|Secondary|Proportion Receiving Pap Test at 12 Months|The outcome will be ascertained for each patient through chart review. The effectiveness of each intervention will be assessed through a comparison of screening rates between each of the four intervention arms (letter, email, phone, letter/email/phone) and the control arm (usual care/opportunistic screening).|12 months||||Participants|||Count of Participants
2578582|NCT02427399|Secondary|Proportion Receiving Pap Test at 6 Months|The outcome will be ascertained for each patient through chart review. The effectiveness of each intervention will be assessed through a comparison of screening rates between each of the four intervention arms (letter, email, phone, letter/email/phone) and the control arm (usual care/opportunistic screening).|6 months||||Participants|||Count of Participants
2578583|NCT02427399|Primary|Proportion of Patients Who Receive a Pap Test at End of Follow up|The outcome will be ascertained for each patient through chart review. The effectiveness of each intervention will be assessed through a comparison of screening rates between each of the four intervention arms (letter, email, phone, letter/email/phone) and the control arm (usual care/opportunistic screening).|18 months||||Participants|||Count of Participants
2578584|NCT02427100|Primary|Accelerometer-Measured Physical Activity: Moderate to Vigorous Intensity Physical Activity|Linear Mixed Model (LMM) methods were used to evaluate differences in daily accelerometer-measured MVPA measured over a 28-day period using SAS version 9.4. Daily accelerometer measured activity was NOT averaged or summarized into a single variable. Rather, daily activity summaries over 28 days were compared between the intervention and control group (see Kendzor et al., 2017, Journal of Physical ACtivity and Health).|Daily over 4 weeks (repeated measures analysis; day 15 excluded because accelerometers were replaced with newly charged accelerometers)|All participants included.|||daily minutes||Inter-Quartile Range|Median
2578585|NCT02427100|Primary|Automated Self-Administered 24-Hour Dietary Recall: Fruit/Vegetable, Cups||4 weeks post-enrollment|In the control group (n = 15), 1 participant who attended the visit did not complete a dietary recall (leaving a total of 14 participants). In the intervention group, 2 participants did not attend the visit, and 1 who attended did not complete a dietary recall (leaving a total of 14 participants).|||cups||Standard Error|Least Squares Mean
2578586|NCT02426918|Secondary|Percentage of Participants Who Showed Microbiological Evidence of Cure 48 to 72 Hours From Randomization, EOT, and STFU|The microbiological outcome was assessed by the sponsor at 48 to 72 hours from randomization, EOT and STFU. It was based on blood and skin lesion identification results from baseline samples and skin lesion identification results from baseline samples and skin lesion identification results from follow-up samples as well as on, molecular typing results, and the IACO. Microbiological eradication rate was defined as proportion of participants with 'Documented Eradication' (absence of baseline pathogen(s) in follow-up cultures of the original site of infection.) or 'Presumed Eradication' (no material available for culture and an IACO of 'Success') in relation to the total number of participants in the respective treatment group.|48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19)|mITT population included all randomized participants who were culture positive for any staphylococcal species considered pathogenic and received at least one dose of study medication.|||percentage of participants|||Number
2578620|NCT02426138|Primary|Healthy Eating Index 2010 Score|Calculated using data from ASA24 24-hour dietary recall tool Healthy Eating Index 2010 Score Minimum and Maximum range = 0 to 100 Higher scores indicate better diet quality The score is an average of the three-time periods that data was collected|Average of 3 24-hour food recalls per study period (on and off meals; one in-person visit and 2 over the phone at 4 and 8 weeks into the study)|ITT|||units on a scale||Standard Deviation|Mean
2578587|NCT02426918|Secondary|Percentage of Participants With a Composite Assessment of Clinical Outcome (CACO) of Success|CACO of treatment was determined as a combined outcome of early response to treatment (at 48 to 72 hours from randomization) and IACO at the STFU visit. Participants had a CACO of success if they met both of the following criteria: An early response to treatment (at 48 to 72 hours from randomization) (ECR = responder) and a clinical outcome of success at the STFU visit (7 to 14 days after EOT) based on IACO (IACO = success).|48 to 72 hours after randomization (Day 4) and STFU (Day 19)|mITT population included all randomized participants who were culture positive for any staphylococcal species considered pathogenic and received at least one dose of study medication.|||percentage of participants|||Number
2578588|NCT02426918|Secondary|Clinical Success Rate: Percentage of Participants Assessed by the Sponsor as Responders After 7 to 10 Days of Treatment at EOT and STFU|The Sponsor's Assessment of Clinical Outcome was obtained at EOT and STFU visits based on IACO and additional criteria. Sponsor assessed participants as clinical failure if they required non-study or rescue antibiotics due to lack of efficacy after at least 48 hours from randomization or experienced drug-related serious adverse events (SAEs) or discontinuation of study medication for drug-related AEs or required antibiotic therapy for longer than 10 days or had the need for unplanned surgical intervention >48 hours after randomization. As per IACO, clinical success was resolution or near resolution of most disease-specific signs and symptoms and no new signs, symptoms or complications. Clinical failure was requirement for additional antibiotic therapy or incision and drainage of ABSSSI site or unplanned major surgical intervention or development of osteomyelitis.|EOT (Day 12) and STFU (Day 19)|mITT population included all randomized participants who were culture positive for any staphylococcal species considered pathogenic and received at least one dose of study medication.|||percentage of participants|||Number
2578589|NCT02426918|Secondary|Clinical Success Rate: Percentage of Participants Assessed by the Investigator as Responders at 48 to 72 Hours From Randomization, at End of Treatment (EOT) and Short-term Follow-up (STFU)|The Investigator Assessment of Clinical Outcome (IACO) of treatment was assessed for each participant as success or failure at 48 to 72 hours after randomization at EOT and STFU visits. Clinical success was resolution or near resolution of most disease-specific signs and symptoms and no new signs, symptoms, or complications attributable to ABSSSI such that no further antibiotic therapy is required for treatment of original site of infection. Clinical failure was requirement for additional antibiotic therapy for treatment of the original site of infection or incision and drainage of ABSSSI site that was not both anticipated and completed within a 48- to 72-hour window following randomization, or unplanned major surgical intervention required due to failure of study medication or development of osteomyelitis after baseline. Participants who met both success criteria and none of failure criteria were considered as a clinical success for IACO.|48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19)|mITT population included all randomized participants who were culture positive for any staphylococcal species considered pathogenic and received at least one dose of study medication.|||percentage of participants|||Number
2578590|NCT02426918|Primary|Early Clinical Response Rate (ECRR): Percentage of Responders to Treatment at 48 to 72 Hours From Randomization as Assessed by the Investigator|ECRR was defined as the percentage of responders to treatment at 48 to 72 hours from randomization. Responders were the participants who showed greater than or equal to (≥) 20% reduction in area of the primary lesion involving erythema, edema, or induration of the primary ABSSSI lesion (as assessed by the ruler method) at 48 to 72 hours compared to baseline.|At 48 to 72 hours from randomization (Day 4)|Microbiological Intent-to-Treat (mITT) population included all randomized participants who were culture positive for any staphylococcal species considered pathogenic and received at least one dose of study medication.|||percentage of participants|||Number
2578591|NCT02426749|Secondary|Change From Baseline in MADRS Score at Post-treatment Sessions|MADRS is the Montgomery Asberg Depression Rating Scale. Scores range from 0 to 60, with higher scores meaning that the subject has a higher degree of depression.|Immediately following treatment (4 weeks after baseline)||||score on a scale||Standard Deviation|Mean
2578592|NCT02426749|Secondary|Change From Baseline in MoCA Score at Post-treatment Sessions.|MoCA is the Montreal Cognitive Assessment; the scale ranges from 0 to 30 points. Higher scores indicate a higher cognitive ability.|Immediately following treatment (4 weeks after baseline)||||score on a scale||Standard Deviation|Mean
2578593|NCT02426749|Primary|Change From Baseline in EVestG Field Potential's Features at Post Treatment Sessions|EVestG is the Electrovestibulography assessment, in which features of the neural field potential are extracted. The measurement here is a calculation of the area under the AP curve. The area is a product of the number of samples (1 / 41667 s each) and the normalized voltage (normalized so the field potential peak has a magnitude of 1). The result is summed over all detected field potentials. Due to the normalization, in a practical sense this value gives a metric of how wide or narrow the calculated field potential shape is.|Immediately following treatment (4 weeks after baseline)||||product of normalized voltage & samples||Standard Deviation|Mean
2578594|NCT02426749|Primary|Change From Baseline in RPQ Score at Post-treatment Sessions|RPQ is the Rivermead Post Concussion Symptoms Questionnaire. Scale ranges from 0 to 64 points, with higher scores representing a greater number or severity of reported symptoms.|Immediately following treatment (4 weeks after baseline)||||units on a scale||Standard Deviation|Mean
2578595|NCT02426658|Secondary|Response Rate|Response rate will be estimated every 6 weeks for patients, and these estimates will be presented with confidence intervals.|Up to 2 years|||||||
2578596|NCT02426658|Secondary|Overall Survival|Examined by estimating a Kaplan-Meier survival curve using all patients enrolled.|The duration of time from the start of treatment to date of death or date of last contact, assessed up to 2 years|||||||
2578597|NCT02426658|Secondary|Incidence of Hematologic Toxicity, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|The number and type of toxicities observed during this protocol will be estimated, focusing on unexpected grade 3 or higher toxicities. No formal statistical tests will be done on these estimates.|Up to 30 days||2021-06-30|06/2021||||
2578621|NCT02426125|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group.|18 Months|All randomized participants who received at least one dose of study drug at baseline and post-baseline.|||Participants|||Count of Participants
2596889|NCT02203630|Secondary|Number of Participants Developing Peripheral Limb Ischemia||Up to 28 days||||Participants|||Count of Participants
2578598|NCT02426658|Primary|Time to Tumor Progression|It will be determined whether each patient has a progression (or dies) before or after 12 weeks. A 95% exact (Clopper Pearson) confidence interval will then be around the proportion with PFS greater than or equal to 12 weeks. If this confidence interval includes 50% then that would provide evidence that the therapy is potentially promising. If the upper bound of the confidence interval does not include 50% then this would indicate that the treatment may not be promising for patients. In addition, a Kaplan Meier survival curve will be constructed to describe the time to progression data.|The duration of time from the start of treatment to the time of progression, death, or date of last contact, assessed up to 2 years||||months||95% Confidence Interval|Median
2578599|NCT02426658|Primary|Change in Quality of Life (QOL), Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) and QLQ-Lung Cancer 13-item (LC13)|Quality of life will be assessed at each treatment time (i.e. every three weeks). A longitudinal mixed models analysis will be used to look at QOL over the time course. A paired t-test will also be calculated to see if the average change is more than 0 (worsening) versus a two-sided alternative that the difference is 0 or better. Score range from 0-100 (1 = not at all, 2 = a little, 3 = quite a bit, or 4 = very much). The higher the score, the greater the change in the quality of life for the worse.|Baseline to 12 weeks||||score on a scale||Standard Error|Mean
2578600|NCT02426580|Primary|Normalized Protein Catabolic Rate (nPCR)|We use software (PD ADEQUEST 2.0) to conduct the Peritoneal Equilibration Test (PET) test. The result of PET test can offered the value of nPCR. nPCR can estimate daily protein intake of patients. Its units is g/(kg*d).|12 months||||g/(kg*d)||Standard Deviation|Mean
2578601|NCT02426541|Primary|Adjusted Change From Baseline in Skeletal Muscle Insulin-stimulated Gluocose Uptake|Adjusted change from baseline in skeletal muscle insulin-stimulated gluocose uptake (umol/min/kg)|From baseline to Week 8|Full analysis set|||umol/min/kg||Standard Error|Least Squares Mean
2578602|NCT02426541|Secondary|Adjusted Change in Liver Insulin-stimulated Glucose Uptake From Baseline to Week 8|Adjusted change in liver insulin-stimulated glucose uptake assessed by hyperglycemic-euglycemic clamp using F-FDG PET|Baseline to Week 8|Full analysis set|||umol/min/kg||Standard Error|Least Squares Mean
2578603|NCT02426541|Secondary|Adjusted Change in Adipose Tissue Insulin-stimulated Glucose Uptake|Change in adipose tissue insulin-stimulated glucose uptake assessed by hyperglycemic-euglycemic clamp using F-FDG PET|Baseline to Week 8|Full analysis set|||umol/min/kg||Standard Error|Least Squares Mean
2578604|NCT02426138|Other Pre-specified|Total Cholesterol|A fasting blood draw will be used to measure: Total Cholesterol|Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw|ITT|||mg/dl||Standard Deviation|Mean
2578605|NCT02426138|Other Pre-specified|HDL Cholesterol|A fasting blood draw will be used to measure: HDL Cholesterol|Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw|ITT|||mg/dl||Standard Deviation|Mean
2578606|NCT02426138|Other Pre-specified|Triglycerides|A fasting blood draw will be used to measure: Triglycerides|Measured at end of On-Meals Period and end of Off-Meals Period for each participant by fasting blood draw|ITT|||mg/dl||Inter-Quartile Range|Median
2578607|NCT02426138|Other Pre-specified|Number of Participants With Self-reported Hypoglycemia|Report of hypoglycemia requiring assistance in last 3 months|Measured at end of On-Meals Period and end of Off-Meals Period for each participant|ITT|||Participants|||Count of Participants
2578608|NCT02426138|Other Pre-specified|Change From Baseline in Cognitive Burden (Assessed Using Times on the Stroop Task)|This outcome was planned to be measured but not measured owing to technical difficulties in assessment|Measured at end of On-Meals Period and end of Off-Meals Period for each participant|This outcome was planned to be measured but not measured owing to technical difficulties in assessment||||||
2578609|NCT02426138|Other Pre-specified|Depressive Symptoms (Assessed Using the PHQ-8 Scale)|Patient Health Questionnaire - 8 item version. The score ranges 0-24, The lower score represents less depressive symptoms|Measured at end of On-Meals Period and end of Off-Meals Period for each participant|ITT|||units on a scale||Standard Deviation|Mean
2578610|NCT02426138|Other Pre-specified|Number of Participants With Food and Medication Trade-offs|Prevalence of food and medication trade-offs between groups|Measured at end of On-Meals Period and end of Off-Meals Period for each participant|ITT|||Participants|||Count of Participants
2578611|NCT02426138|Other Pre-specified|Number of Participants With Cost Related Medication Under-Use|Cost Related Medication Under-use (Defined as > 0 affirmative responses to 4-items on cost-related medication under-use from the medication expenditure panel survey)|Measured at end of On-Meals Period and end of Off-Meals Period for each participant|ITT|||Participants|||Count of Participants
2578612|NCT02426138|Other Pre-specified|Change From Baseline in Medication Adherence|Change from baseline in Medication Adherence Rating Scale (Assessed using medication adherence rating scale) Range is 0-25 The higher the number the better|Measured at end of On-Meals Period and end of Off-Meals Period for each participant|ITT|||units on a scale||Standard Deviation|Mean
2578613|NCT02426138|Other Pre-specified|Diastolic Blood Pressure|Measured using a calibrated sphygmomanometer with appropriate cuff sizes based on arm circumference. Average of 2 readings, first manual and second automated at 1 min intervals following a 5 min period of rest.|Measured at end of On-Meals Period and end of Off-Meals Period for each participant using a calibrated sphygmomanometer|ITT|||mm hg||Standard Deviation|Mean
2578614|NCT02426138|Other Pre-specified|Systolic Blood Pressure|Measured using a calibrated sphygmomanometer with appropriate cuff sizes based on arm circumference. Average of 2 readings, first manual and second automated at 1 min intervals following a 5 min period of rest.|Measured at end of On-Meals Period and end of Off-Meals Period for each participant using a calibrated sphygmomanometer|ITT|||mm hg||Standard Deviation|Mean
2578615|NCT02426138|Other Pre-specified|Body Mass Index|"Body Mass Index will be measured in light street clothes (without shoes) using a single calibrated scale.~Height measured using a stadiometer. Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters.~A high BMI can be an indicator of high body fatness."|Measured at end of On-Meals Period and end of Off-Meals Period for each participant|ITT|||kg/m^2||Standard Deviation|Mean
2578616|NCT02426138|Other Pre-specified|LDL Cholesterol|A fasting blood draw will be used to measure: LDL Cholesterol|Measured at end of On-Meals Period and end of Off-Meals Period for each participant|ITT|||mg/dl||Standard Deviation|Mean
2578623|NCT02426125|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab|Maximum concentration (Cmax) of Ramucirumab at the end of ramucirumab infusion|Cycle 1 and Cycle 9, Day 1: Predose, Postdose|The first randomized participants who had evaluable PK data.|||microgram/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2578624|NCT02426125|Secondary|Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)|The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions. Participants indicated their current health status by marking on a visual analogue scale (VAS) ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).|Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)|All randomized participants with baseline and 30-day follow-up data.|||millimeter (mm)||Standard Deviation|Mean
2578625|NCT02426125|Secondary|Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score|The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Participants completed the 5-level (no problem, slight problem, moderate problem, severe problem, and inability or extreme problem), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions. Scores range from 0 (death) to 1 (perfect health), but scores <0 are possible based on the algorithm.|Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)|All randomized participants with baseline and 30-day follow-up data.|||units on a scale||Standard Deviation|Mean
2578626|NCT02426125|Secondary|Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale|Time to sustained deterioration was defined as time from randomization to first worsening in QoL with no subsequent non-worsened assessment. Worsening in global health status/QoL was defined as a decrease of ≥10 points on a 100-point scale. If a participant did not report worsening, time to sustained deterioration was censored at date of last non-worsened assessment. Scores for global health status/QoL range from 0 to 100 with; higher scores representing better QoL.|Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)|All randomized participants. Censored participants: Ramucirumab + Docetaxel = 167, Placebo + Docetaxel = 170.|||Months||95% Confidence Interval|Median
2578627|NCT02426125|Secondary|Duration of Response (DoR)|Objective response was achieved if they had a best overall response of CR or PR. Target lesions- CR: Disappearance of all lesions; any pathological lymph nodes have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study(the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions - CR: Disappearance of all lesions and normalization of tumour marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s). If a participant was not known to have died or have radiographically documented PD as of the data inclusion cutoff date, DOR was censored at the date of the last adequate tumor assessment.|Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up to 18 Months)|The first randomized participants with CR or PR. Participants censored in Ramucirumab + Docetaxel = 21 and in Placebo + Docetaxel = 9.|||Months||95% Confidence Interval|Median
2578628|NCT02426125|Secondary|Percentage of Participants With Disease Control Rate (DCR)|DCR is the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1. Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).|Randomization to Disease Progression (Up to 18 Months)|The first randomized participants.|||percentage of participants||95% Confidence Interval|Number
2578629|NCT02426125|Secondary|Percentage of Participants With an Objective Response Rate (ORR)|Objective response rate is defined as the percentage of participants who achieve a best overall response of complete response (CR) + partial response (PR). ORR = CR + PR. CR is the disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. Best overall response is classified based on the overall responses assessed by study investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.|Randomization to Disease Progression (Up to 18 Months)|The first randomized participants.|||percentage of participants||95% Confidence Interval|Number
2578630|NCT02426125|Secondary|Overall Survival (OS)|OS is the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data inclusion cutoff date for a particular analysis, OS was censored for that analysis at the last known alive date prior to the data inclusion cutoff date.|Randomization to Date of Death from Any Cause (Up to 21 Months)|All randomized participants. Censored participants: Ramucirumab + Docetaxel = 78, Placebo + Docetaxel = 67.|||Months||95% Confidence Interval|Median
2578656|NCT02425111|Secondary|Part A: Percentage of Participants Achieving Clinical Response at Week 10|Clinical response is defined as Crohn's Disease Activity Index (CDAI) decrease from Baseline of ≥100 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.|Baseline and Week 10|FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2578631|NCT02426125|Primary|Progression Free Survival (PFS)|PFS defined as time from first day of therapy to first evidence of disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If participant does not have complete baseline disease assessment, then PFS time was censored at date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for participant. If participant is not known to have died or have objective progression as of data inclusion cutoff date for analysis, PFS time was censored at last adequate tumor assessment date.|Randomization to Radiological Disease Progression or Death from Any Cause (Up to 18 Months)|The first randomized participants. Censored participants: Ramucirumab + Docetaxel = 58, Placebo + Docetaxel =38.|||Months||95% Confidence Interval|Median
2578632|NCT02425956|Secondary|Serum Ferritin Based on Blood Draw|The secondary outcome is collection of serum ferritin from hematologic analysis (blood draw analyzed by site central lab).|48 hours post MR scan or 24 hours pre MR scan|Every enrolled subject|||mg FE /g dry||Standard Deviation|Mean
2578633|NCT02425956|Primary|Per Subject Evaluable DICOM Data Sets From Liver MRI|The primary outcome measure is collection of evaluable (based on physician determination) MR DICOM datasets including valid 1.5 and 3.0T image data, P-file, R2* maps, and raw data for each enrolled subject. The datasets were gathered via three independent MR scans conducted within a three hour time block, with up to ten minutes break in between.|48 hours pre or 24 hours post blood draw|MR DICOM datasets were gathered for each enrolled subject (total of three scans per subject equals one complete dataset)|||Participants|||Count of Participants
2578634|NCT02425826|Secondary|Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) During the Apremilast-Exposure Phase|Treatment-Emergent Adverse Events (TEAEs) are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of study drug or study treatment discontinuation date, whichever was later. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.|Date of first dose of apremilast during the placebo controlled phase or date of first dose of apremilast after week 16; overall maximum duration of exposure was 61.5 weeks during apremilast-exposure phase|The safety population includes all participants who were randomized and received at least one dose of study drug; apremilast participants as treated.|||participants|||Number
2578635|NCT02425826|Secondary|Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase|Treatment-Emergent Adverse Events (TEAEs) are defined as any AEs that begin or worsen on or after the start of study drug through 28 days after the last dose of study drug or study treatment discontinuation date, whichever was later. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.|From first dose of study drug to Week 16; maximum duration of exposure was 20.1 weeks during placebo controlled phase|The safety population includes all participants who were randomized and received at least one dose of study drug.|||participants|||Number
2578636|NCT02425826|Secondary|Percentage of Participants With Scalp Psoriasis Who Were Initially Randomized to Apremilast and Maintained the Scalp Physician's Global Assessment (ScPGA) Response From Week 16 to Week 52.|The ScPGA will assess scalp involvement, if present at baseline. The 6-point ScPGA scale includes three dimensions (Plaque Thickening, Scaling, and Erythema) and a global assessment with scores range from 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), to 5 (very severe). Analysis of ScPGA is restricted to the participants with scalp involvement at baseline.|Week 16 to Week 52|Participants who were initially randomized to apremilast and continued through week 52.|||percentage of participants||95% Confidence Interval|Number
2578637|NCT02425826|Secondary|Mean Percentage Change From Baseline in the Product of BSA (%) x sPGA at Week 52|"BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand (entire palmar surface or handprint including the fingers), which equates to approximately 1% of total body surface area. The sPGA is a 6-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), 5 (very severe) incorporating a separate assessment of the severity of the three primary signs of the plaques of all involved areas: erythema, scaling and plaque elevation with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are rounded to the nearest whole number to result in the final score."|Baseline to Week 52|Apremilast participants who entered and were treated in the apremilast extension phase.|||percentage change||Standard Deviation|Mean
2578638|NCT02425826|Secondary|Percentage of Participants Who Achieved at Least a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-75 From Baseline at Week 16|The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.|||percentage of participants||95% Confidence Interval|Number
2578667|NCT02425098|Secondary|Percentage of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination|Vaccine Viremia was assessed for each of the four vaccine strains: TDV-1, TDV-2, TDV-3 and TDV-4. Vaccine viral ribonucleic acid (RNA) was detected by reverse transcription-polymerase chain reaction (RT-PCR) assay.|Days 5, 7, 9, 11, 15, 17, 21 and 30|Participants from the safety analysis set, all randomized participants who received at least 1 dose of study vaccine, with data available at the given time-point.|||percentage of participants||95% Confidence Interval|Number
2578639|NCT02425826|Secondary|Percentage of Participants Who Achieved at Least a 50% Improvement (Response) in the Psoriasis Area and Severity Index (PASI)-50 From Baseline at Week 16.|The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.|||percentage of participants||95% Confidence Interval|Number
2578640|NCT02425826|Secondary|Mean Percentage Change From Baseline in Psoriasis Area Severity Index Score (PASI) at Week 16|The PASI score is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.|||percentage change||Standard Deviation|Mean
2578641|NCT02425826|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 52|The TSQM version II is an 11-question self-administered instrument to understand a participants satisfaction on the current therapy. The TSQM scale comprises four domains, on which participants evaluate their medication (i.e., effectiveness, side effects, convenience and global satisfaction. TSQM scores range from 0 to 100 for each domain; a higher score indicates higher satisfaction with treatment.|Baseline to week 52|Apremilast participants who entered and were treated in the apremilast extension phase.|||units on a scale||Standard Deviation|Mean
2578642|NCT02425826|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) Version II at Week 16|The TSQM version II is an 11-question self-administered instrument to understand a participation's satisfaction with the current therapy. The TSQM scale comprises four domains, on which participants evaluate their medication (i.e., effectiveness, side effects, convenience and global satisfaction. TSQM scores range from 0 to 100 for each domain; a higher score mean indicates higher satisfaction with treatment.|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed LOCF.|||units on a scale||Standard Deviation|Mean
2578643|NCT02425826|Secondary|Percentage of Participants With Scalp Psoriasis Who Achieved a Clear (0) or Minimal (1) on Scalp Physician's Global Assessment (ScPGA) Scale at Week 16.|The ScPGA assessed scalp involvement, if present at baseline. The 6-point ScPGA scale includes three dimensions (Plaque Thickening, Scaling, and Erythema) and a global assessment. Scores range from 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), to 5 (very severe). Analysis of ScPGA was restricted to the participants with scalp involvement at baseline.|Baseline to Week 16 (end of phase)|The ITT population with scalp psoriasis who were randomized. Participants with at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.|||percentage of participants||95% Confidence Interval|Number
2578644|NCT02425826|Secondary|Mean Change From Baseline in Pruritus Visual Analog Scale (VAS)|The Pruritus VAS assessment was conducted at the baseline visit and each post-baseline visit. The participant was asked to place a vertical stroke on a 100 mm VAS on which the left-hand boundary (0) represents no itch, and the right-hand boundary (100) represents itch as severe as can be imagined. The distance from the mark to the left-hand boundary will be recorded. The Pruritus VAS score ranges from 0 to 100. Higher scores correspond to more severe symptom.|Baseline to Weeks 1 and 16 (end of phase)|ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.|||units on a scale||Standard Deviation|Mean
2578645|NCT02425826|Secondary|Percentage of Participants Who Achieved a Clear (0) or Very Mild (1) on Patient Global Assessment (PtGA) Scale at Week 16 From Baseline|The PtGA response rate is defined as the percentage of participants achieving 0 (clear) or 1 (very mild) on the PtGA scale at Week 16. The PtGA is the assessment by the participant of the overall disease severity at the time of evaluation. The PtGA is a 5-point scale ranging from 0 (clear) to 4 (severe).|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.|||percentage of participants||95% Confidence Interval|Number
2578646|NCT02425826|Secondary|Percentage of Participants Who Achieved a sPGA Score of Clear (0) or Almost Clear (1) at Week 16 From Baseline|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 6-point scale, ranging from 0 (clear) to 5 (very severe), with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are averaged and rounded to the nearest whole number to result in the final sPGA score.|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with and at least one post-baseline value are included. A missing value at Week 16 was imputed by LOCF.|||percentage of participants||95% Confidence Interval|Number
2578677|NCT02425098|Primary|Seropositivity Rate for Each of the Four Dengue Serotypes at Day 30|Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.|Day 30|The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here ‘number analyzed’ refers to participants with valid MNT results available at given time-point.|||percentage of participants||95% Confidence Interval|Number
2578647|NCT02425826|Secondary|Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16|"DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if No, then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being A lot, A little, or Not at all (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best."|Baseline to Week 16 (end of phase)|The ITT population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value are included. A missing value at Week 16 (end of phase) was imputed by LOCF.|||units on a scale||Standard Deviation|Mean
2578648|NCT02425826|Primary|Mean Percentage Change From Baseline in the Product of BSA (%) and the sPGA Which is Considered as the Total Psoriasis Severity Index at Week 16|"BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the participant's hand (entire palmar surface or handprint including the fingers), which equates to approximately 1% of total body surface area. The sPGA is a 6-point scale ranging from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe), 5 (very severe) incorporating a separate assessment of the severity of the three primary signs of the plaques of all involved areas: erythema, scaling and plaque elevation with an overall sPGA calculated as (E + I + D)/3. Scores for each assessment are rounded to the nearest whole number to result in the final score. The range of BSA*sPGA mean percentage change from baseline to week 16 (end of phase) were -100 to 344.4 and -100 to 100 for the placebo and apremilast groups respectively. Higher scores represented worse outcomes."|Baseline to Week 16 (end of phase)|The Intent-to-Treat (ITT) population consisted of all participants who were randomized. Participants with a baseline value and at least one post-baseline value were included. A missing value at Week 16 was imputed by last observation carried forward. (LOCF).|||percentage change||Standard Deviation|Mean
2578649|NCT02425449|Primary|Fade on Train of Four Stimulation|We stimulated the ulnar nerve at the wrist four times (over 1.5 seconds) every 20 seconds. We measured the ratio of the fourth contraction to the first contraction before and after the administration of succinylcholine. Before administering succinylcholine the ratio is normally one. After the administration of succinylcholine the first contraction diminishes, but the fourth contraction diminishes even more. This results in a ratio of T4 to T1 being less than one. The lowest ratio recorded after the administration after the administration of succinylcholine is reported as our outcome measure.|for the duration of the effect of succinylcholine generally expected to be 6-10 minutes||||Ratio||Standard Deviation|Mean
2578650|NCT02425111|Secondary|Part B: Percentage of Participants With Durable Clinical Remission|Durable clinical remission is defined as clinical remission at both Week 26 and Week 52. Clinical remission is defined as CDAI score of ≤150 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease. The percentage of participants assessed at Week 52 who had clinical remission at Week 26 of Part A and also had clinical remission at Week 52 is reported.|Weeks 26 and 52|FAS-Extension is the subset of participants in the FAS who were able to be consented for Part B, based on the timing of Amendment 4. FAS included all enrolled participants who received at least 1 dose of study drug. Participants with missing durable clinical remission status are considered as No durable clinical remission.|||percentage of participants||95% Confidence Interval|Number
2578651|NCT02425111|Secondary|Part B: Percentage of Participants Achieving Clinical Remission at Week 52|Clinical remission is defined as CDAI score of ≤150 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.|Week 52|FAS-Extension is the subset of participants in the FAS who were able to be consented for Part B, based on the timing of Amendment 4. FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2578652|NCT02425111|Secondary|Part A: Percentage of Participants Achieving Clinical Remission at Week 26|Clinical remission is defined as CDAI score of ≤150 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.|Week 26|FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2578653|NCT02425111|Secondary|Part A: Percentage of Participants Achieving Clinical Remission at Week 10|Clinical remission is defined as CDAI score of ≤150 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.|Week 10|FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2578654|NCT02425111|Secondary|Part B: Percentage of Participants Achieving Clinical Response at Week 52|Clinical response is defined as CDAI decrease from Baseline of ≥100 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.|Baseline and Week 52|FAS-Extension is the subset of participants in the FAS who were able to be consented for Part B, based on the timing of Amendment 4. FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2578655|NCT02425111|Secondary|Part A: Percentage of Participants Achieving Clinical Response at Week 26|Clinical response is defined as CDAI decrease from Baseline of ≥100 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.|Baseline and Week 26|FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2578657|NCT02425111|Secondary|Part B: Percentage of Participants With Endoscopic Response at Week 52|Endoscopic response is defined as a reduction in SES-CD from Baseline by ≥50%. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.|Baseline and Week 52|FAS-Extension is the subset of participants in the FAS who were able to be consented for Part B, based on the timing of Amendment 4. FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2578658|NCT02425111|Secondary|Part A: Percentage of Participants With Endoscopic Response at Week 26|Endoscopic response is defined as a reduction in SES-CD from Baseline by ≥50%. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.|Baseline and Week 26|FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2578659|NCT02425111|Secondary|Part A: Percentage of Participants With Endoscopic Response at Week 14|Endoscopic response is defined as a reduction in SES-CD from Baseline by ≥50%. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.|Baseline and Week 14|FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2578660|NCT02425111|Secondary|Part B: Percentage of Participants Achieving Endoscopic Remission at Week 52|Endoscopic remission is defined as a SES-CD score of ≤4. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.|Week 52|FAS-Extension is the subset of participants in the FAS who were able to be consented for Part B, based on the timing of Amendment 4. FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2578661|NCT02425111|Secondary|Part A: Percentage of Participants Achieving Endoscopic Remission at Week 14|Endoscopic remission is defined as a SES-CD score of ≤4. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.|Week 14|FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2578662|NCT02425111|Secondary|Part B: Percentage of Participants Achieving Complete Mucosal Healing at Week 52|Complete mucosal healing is defined as absence of ulceration.|Week 52|FAS-Extension is the subset of participants in the FAS who were able to be consented for Part B, based on the timing of Amendment 4. FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2578663|NCT02425111|Secondary|Part A: Percentage of Participants Achieving Complete Mucosal Healing at Week 26|Complete mucosal healing is defined as absence of ulceration.|Week 26|FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2578664|NCT02425111|Primary|Part A: Percentage of Participants Achieving Endoscopic Remission at Week 26|Endoscopic remission is defined as a simple endoscopic score for Crohn's Disease (SES-CD) score of ≤4. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.|Week 26|FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2578665|NCT02425098|Secondary|Level of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination|Vaccine Viremia was assessed for each of the four vaccine strains: TDV-1, TDV-2, TDV-3 and TDV-4. Vaccine viral ribonucleic acid (RNA) was detected by reverse transcription-polymerase chain reaction (RT-PCR) assay.|Days 5, 7, 9, 11, 15, 17, 21 and 30|Participants from the safety analysis set, all randomized participants who received at least 1 dose of study vaccine. Here ‘number analyzed’ refers to participants with a positive vaccine viremia test result.|||log10 [genome equivalents per mL]||Standard Deviation|Mean
2578666|NCT02425098|Secondary|Duration of Vaccine Viremia for Each of the Four Vaccine Strains After Vaccination|The duration of vaccine viremia for each vaccine strain was defined as the date when vaccine viremia was last detected (positive result) to date when vaccine viremia was first detected (positive result) + 1 day. It was assessed for each of the four vaccine strains: TDV-1, TDV-2, TDV-3 and TDV-4. Vaccine viral ribonucleic acid (RNA) was detected by reverse transcription-polymerase chain reaction (RT-PCR) assay.|Days 5, 7, 9, 11, 15, 17, 21 and 30|Participants from the safety analysis set, all randomized participants who received at least 1 dose of study vaccine. Here ‘number analyzed’ refers to participants with a positive vaccine viremia test result.|||days||Full Range|Median
2580793|NCT02403154|Secondary|Predictors of Outcome (Factors Such as Age, Gender, BMI, Additional Injuries)|We will evaluate factors such as age, gender, BMI, additional injuries to see if they help predict outcome|24 hours - 24 months|||||||
2578668|NCT02425098|Secondary|Seropositivity Rate for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status|Baseline dengue seropositivity was based on the MNT result and was defined as a reciprocal neutralizing titer ≥10 for one or more dengue serotype at baseline. Seropositive rate was defined as a reciprocal neutralizing titer ≥ 10. Seropositivity was assessed for the four Dengue serotypes are DENV-1, DENV-2, DENV-3, and DEN-4.|Days 15, 30, 90, 180, and 365|The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here ‘number analyzed’ refers to participants with valid MNT results available at given time-point.|||percentage of participants||95% Confidence Interval|Number
2578669|NCT02425098|Secondary|Geometric Mean Neutralizing Antibody Titers (GMT) for Each of the Four Dengue Serotypes Assessed by Dengue Baseline Seropositivity (MNT) Status|Baseline dengue seropositivity was based on the microneutralization test (MNT) result and was defined as a reciprocal neutralizing titer ≥10 for one or more dengue serotype at baseline. The four DENV serotypes are DENV-1, DENV-2, DENV-3, and DENV-4.|Days 15, 30, 90, 180 and 365|The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here ‘number analyzed’ refers to participants with valid MNT results available at given time-point.|||Titer||95% Confidence Interval|Geometric Mean
2578670|NCT02425098|Secondary|Number of Participants With Serious Adverse Events (SAEs)|A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above-mentioned criteria.|From first vaccination through end of study (Day 365)|The safety set included all randomized participants who received the study vaccine.|||Participants|||Count of Participants
2578671|NCT02425098|Secondary|Number of Participants With at Least One Unsolicited Adverse Events (AEs) Following Vaccination|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a study vaccine; it does not necessarily have to have a causal relationship with study vaccine administration.|Within 28 days after Vaccination|The safety set included all randomized participants who received the study vaccine.|||Participants|||Count of Participants
2578672|NCT02425098|Secondary|Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity|Solicited systemic AEs were collected by participants using diary cards within 14 days after vaccination and included fever, headache, asthenia, malaise and myalgia. Severity grades were: Grade 0: none, Grade 1: mild (no interference with daily activity), Grade 2: moderate (interference with daily activity with or without treatment), Grade 3: severe (prevents normal daily activity with or without treatment). A systemic AE of fever (defined as ≥ 100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination.|Within 14 days after Vaccination|The safety set included all randomized participants who received the study vaccine. Here 'number analyzed' is the number of participants with data available for analysis. Only categories for which there was at least 1 participant are reported.|||Participants|||Count of Participants
2578673|NCT02425098|Secondary|Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Vaccination by Severity|Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain [Grade 0 (no pain), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents daily activity with or without treatment)], erythema [Grade 0 (<25 mm), 1 (25 − ≤ 50 mm), 2 (>50 − ≤ 100 mm), 3 (> 100 mm)] and swelling [Grade 0 (<25 mm), 1 (25 − ≤ 50 mm), 2 (>50 − ≤ 100 mm), 3 (> 100 mm)].|Within 7 days after Vaccination|The safety set included all randomized participants who received the study vaccine. Here 'number analyzed' is the number of participants with data available for analysis. Only categories for which there was at least 1 participant are reported.|||Participants|||Count of Participants
2578674|NCT02425098|Primary|Seropositivity Rate for Each of the Four Dengue Serotypes at Day 365|Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.|Day 365|The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here ‘number analyzed’ refers to participants with valid MNT results available at given time-point.|||percentage of participants||95% Confidence Interval|Number
2578675|NCT02425098|Primary|Seropositivity Rate for Each of the Four Dengue Serotypes at Day 180|Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.|Day 180|The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here ‘number analyzed’ refers to participants with valid MNT results available at given time-point.|||percentage of participants||95% Confidence Interval|Number
2578676|NCT02425098|Primary|Seropositivity Rate for Each of the Four Dengue Serotypes at Day 90|Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.|Day 90|The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here ‘number analyzed’ refers to participants with valid MNT results available at given time-point.|||percentage of participants||95% Confidence Interval|Number
2578800|NCT02423798|Primary|Sensor Accuracy|Sensor values were compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing day (day 3). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100).|4 months||||percentage||Standard Deviation|Mean
2578678|NCT02425098|Primary|Seropositivity Rate for Each of the Four Dengue Serotypes at Day 15|Seropositivity rate was defined as the percentage of participants being seropositive, derived from titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10 (for each serotype). Seropositivity rates were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4.|Day 15|The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here ‘number analyzed’ refers to participants with valid MNT results available at given time-point.|||percentage of participants||95% Confidence Interval|Number
2578679|NCT02425098|Primary|Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 365|GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.|Day 365|The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here ‘number analyzed’ refers to participants with valid MNT results available at given time-point.|||Titer||95% Confidence Interval|Geometric Mean
2578680|NCT02425098|Primary|Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 180|GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.|Day 180|The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here ‘number analyzed’ refers to participants with valid MNT results available at given time-point.|||Titer||95% Confidence Interval|Geometric Mean
2578681|NCT02425098|Primary|Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 90|GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.|Day 90|The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here ‘number analyzed’ refers to participants with valid MNT results available at given time-point.|||Titer||95% Confidence Interval|Geometric Mean
2578682|NCT02425098|Primary|Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 30|GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by MNT.|Day 30|The PPS included all randomized participants who received the study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here ‘number analyzed’ refers to participants with valid MNT results available at given time-point.|||Titer||95% Confidence Interval|Geometric Mean
2578683|NCT02425098|Primary|Geometric Mean Neutralizing Antibody Titer (GMT) for Each of the Four Dengue Serotypes at Day 15|GMTs were assessed for the four dengue serotypes: DENV-1, DENV-2, DENV-3, and DENV-4, by microneutralization test [MNT].|Day 15|Per-protocol set (PPS) included all randomized participants who received study vaccine and for whom valid pre-dosing and at least one valid post-dosing MNT result was available, and who had no major protocol violations. Here ‘number analyzed’ refers to participants with valid MNT results available at given time-point.|||Titer||95% Confidence Interval|Geometric Mean
2578684|NCT02424799|Secondary|t1/2 of GSK2646264 for Part C|Blood samples were collected at the indicated time point to investigate the PK profile of GSK264624. From the GSK2646264 concentration-time data, the t1/2 was determined using the currently approved and validated software. NA indicated data was not collected due to insufficient number of participants with data to calculate half life.|Pre dose and 4 hours post-dose on Days 1, 4 and 7|PK Population|||hours||Standard Deviation|Mean
2578685|NCT02424799|Secondary|Tmax of GSK2646264 for Part C|Blood samples were collected at the indicated time point to investigate the PK profile of GSK264624. From the GSK2646264 concentration-time data, the tmax was determined using the currently approved and validated software.|Pre dose and 4 hours post-dose on Days 1, 4 and 7|PK Population|||hours||Standard Deviation|Mean
2578686|NCT02424799|Secondary|Cmax of GSK2646264 for Part C|Blood samples were collected at the indicated time point to investigate the PK profile of GSK264624. From the GSK2646264 concentration-time data, the Cmax was determined using the currently approved and validated software.|Pre dose and 4 hours post-dose on Days 1, 4 and 7|PK Population.|||Nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2578687|NCT02424799|Secondary|Tmax of GSK2646264 for Part B|Blood samples were collected at the indicated time point to investigate the PK profile of GSK264624. From the GSK2646264 concentration-time data, the tmax was determined using the currently approved and validated software.|Pre dose, 1 ,2, 4, 8, 12 hours post-dose on Days 1,2,3 and 24 hours post last dose on Day 3|PK Population|||hours||Standard Deviation|Mean
2578688|NCT02424799|Secondary|Terminal Half-life (t1/2) of GSK2646264 for Part B|Blood samples were collected at the indicated time point to investigate the PK profile of GSK264624. From the GSK2646264 concentration-time data, the t1/2 was determined using the currently approved and validated software.|Pre dose, 1 ,2, 4, 8, 12 hours post-dose on Days 1,2,3 and 24 hours post last dose on Day 3|PK Population|||hours||Geometric Coefficient of Variation|Geometric Mean
2578689|NCT02424799|Secondary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC [0-inf]) of GSK2646264 for Part B|Blood samples were collected at the indicated time point to investigate the PK profile of GSK264624. From the GSK2646264 concentration-time data, the AUC (0-infinity) was determined using the currently approved and validated software.|Pre dose, 1 ,2, 4, 8, 12 hours post-dose on Days 1,2,3 and 24 hours post last dose on Day 3|PK Population. Only those participants available at the indicated time points were analyzed.|||Hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2578690|NCT02424799|Secondary|AUC (0-24) of GSK2646264 for Part B|Blood samples were collected at the indicated time point to investigate the PK profile of GSK264624. From the GSK2646264 concentration-time data, the AUC (0-24) was determined using the currently approved and validated software. NA indicates that geometric coefficient of variation could not be computed for Part B (3.5% BSA) GSK2646264 1% as a single participant was analyzed on Day 2.|Pre dose, 1 ,2, 4, 8, 12 hours post-dose on Days 1,2,3 and 24 hours post last dose on Day 3 (Day 4)|PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=x in the category titles).|||Hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2595210|NCT02224820|Secondary|Safety|Adverse events (all clinical laboratory tests, vital signs and ECG jugded as clinically significant were reported as AEs)|9 weeks||||Adverse events|||Number
2578691|NCT02424799|Secondary|Cmax of GSK2646264 for Part B|Blood samples were collected at the indicated time point to investigate the PK profile of GSK264624. From the GSK2646264 concentration-time data, the Cmax was determined using the currently approved and validated software.|Pre dose, 1 ,2, 4, 8, 12 hours post-dose on Days 1,2,3 and 24 hours post last dose on Day 3 (Day 4)|PK Population.|||Nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2578692|NCT02424799|Secondary|AUC [0-t] of GSK2646264 for Part B|Blood samples were collected at the indicated time point to investigate the PK profile of GSK264624. From the GSK2646264 concentration-time data, the AUC (0-t) was determined using the currently approved and validated software.|Pre dose, 1 ,2, 4, 8, 12 hours post-dose on Days 1,2,3 and 24 hours post last dose on Day 3|PK Population|||Hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2578693|NCT02424799|Secondary|t1/2 of GSK2646264 for Part A|Blood samples were collected at the indicated time point to investigate the PK profile of GSK264624. From the GSK2646264 concentration-time data, the t1/2 was determined using the currently approved and validated software. NA indicated t1/2 could not be calculated as we need at least 3 time points after Cmax within the same participant and this criteria could not be fulfilled due to lack of available data.|Day 1 (Pre-dose,1,2,4,8,12,24 hours), Day 2 (Pre-dose,1,2,4,8,12,24 hours), Day 3 (Pre-dose,1,2,4,8,12,24 hours) and Day 4 post-dose at Day 5 (30 and 36 hours), Day 6 (48,54 and 60 hours), Day 7 (72,78 and 84 hours) and Day 8 (96 hours)|PK Population|||hours||Standard Deviation|Mean
2578694|NCT02424799|Secondary|Terminal Half-life (t1/2) of GSK2646264 for Part A|Blood samples were collected at the indicated time point to investigate the PK profile of GSK264624. From the GSK2646264 concentration-time data, the t1/2 was determined using the currently approved and validated software. NA indicated t1/2 could not be calculated as we need at least 3 time points after Cmax within the same participant and this criteria could not be fulfilled due to lack of available data.|Pre dose, 1 ,2, 4, 8, 12 and 24 hours post-dose on Days 1,2,3 and 4|PK Population|||hours||Standard Deviation|Mean
2578695|NCT02424799|Secondary|Tmax of GSK2646264 for Part A|Blood samples were collected at the indicated time point to investigate the PK profile of GSK264624. From the GSK2646264 concentration-time data, the tmax was determined using the currently approved and validated software.|Day 1 (Pre-dose,1,2,4,8,12,24 hours), Day 2 (Pre-dose,1,2,4,8,12,24 hours), Day 3 (Pre-dose,1,2,4,8,12,24 hours) and Day 4 post-dose|PK Population|||hours||Standard Deviation|Mean
2578696|NCT02424799|Secondary|Time to Cmax (Tmax) of GSK2646264 for Part A|Blood samples were collected at the indicated time points to investigate the PK profile of GSK264624. From the GSK2646264 concentration-time data, the tmax was determined using the currently approved and validated software.|Pre dose, 1 ,2, 4, 8, 12 and 24 hours post-dose on Days 1,2 and Day 3|PK Population. Only those participants with data available at the specified time points were analyzed represented by n=x in the category titles).|||hours||Standard Deviation|Mean
2578697|NCT02424799|Secondary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC [0-24]) of GSK2646264 for Part A|Blood samples were collected at the indicated time point to investigate the PK profile of GSK264624. From the GSK2646264 concentration-time data, the AUC (0-24) was determined using the currently approved and validated software.|Pre dose, 1 ,2, 4, 8, 12 and 24 hours post-dose on Days 1,2,3 and 4|PK Population|||Hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2578698|NCT02424799|Secondary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC [0-24]) of GSK2646264 for Part A|Blood samples were collected at the indicated time point to investigate the PK profile of GSK264624. From the GSK2646264 concentration-time data, the AUC (0-24) was determined using the currently approved and validated software. NA indicated data was not collected due to insufficient participants with data.|Pre dose, 1 ,2, 4, 8, 12 and 24 hours post-dose on Days 1,2,3 and 4|PK Population.|||Hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2578699|NCT02424799|Secondary|Cmax of GSK2646264 for Part A|Blood samples were collected at the indicated time points to investigate the PK profile of GSK264624. From the GSK2646264 concentration-time data, the Cmax was determined using the currently approved and validated software.|Day 1 (Pre-dose,1,2,4,8,12,24 hours), Day 2 (Pre-dose,1,2,4,8,12,24 hours), Day 3 (Pre-dose,1,2,4,8,12,24 hours) and Day 4 post-dose|PK Population|||Nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2578700|NCT02424799|Secondary|Maximum Plasma Concentration (Cmax) of GSK2646264 for Part A|Blood samples were collected at the indicated time point to investigate the PK profile of GSK264624. From the GSK2646264 concentration-time data, the Cmax was determined using the currently approved and validated software.|Pre dose, 1 ,2, 4, 8, 12 and 24 hours post-dose on Days 1,2 and Day 3|PK Population. Only those participants with data available at the specified time points were analyzed represented by n=x in the category titles).|||Nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2578701|NCT02424799|Secondary|AUC (0-t) of GSK2646264 for Part A|Blood samples were collected at the indicated time point to investigate the PK profile of GSK264624. From the GSK2646264 concentration-time data, the AUC (0-T) was determined using the currently approved and validated software.|Day 1 (Pre-dose,1,2,4,8,12,24 hours), Day 2 (Pre-dose,1,2,4,8,12,24 hours), Day 3 (Pre-dose,1,2,4,8,12,24 hours) and Day 4 post-dose|PK Population|||Hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2578702|NCT02424799|Secondary|Area Under the Concentration-time Curve From Time 0 to t (AUC [0-t]) of GSK2646264 for Part A|Blood samples were collected at the indicated time point to investigate the PK profile of GSK264624. From the GSK2646264 concentration-time data, the AUC (0-T) was determined using the currently approved and validated software.|Pre dose, 1 ,2, 4, 8, 12 and 24 hours post-dose on Days 1,2 and Day 3|PK Population. Only those participants with data available at the specified time points were analyzed represented by n=x in the category titles).|||Hours*nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2578703|NCT02424799|Secondary|Plasma GSK2646264 PK Concentrations for Part C|Blood samples were collected to assess the plasma concentration of GSK2646264 for Part C on Day 1 (Pre-dose,1 and 4 hours), Day 4 (Pre-dose and 4 hours), Day 7 (Pre-dose and 4 hours), Day 10, Day 15 and follow-up. The actual date and time of each blood sample collection was recorded.|Day 1 (Pre-dose,1 and 4 hours), Day 4 (Pre-dose and 4 hours), Day 7 (Pre-dose and 4 hours), Day 10, Day 15 and follow-up (Day 23)|PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=x in the category titles).|||nanograms/milliliter||Standard Deviation|Mean
2601681|NCT02150837|Secondary|Hip Circumference|Hip circumference expressed as an absolute change from baseline.|8 weeks||||Inches||Standard Deviation|Mean
2578704|NCT02424799|Secondary|Plasma GSK2646264 PK Concentrations for Part B|Blood samples were collected to assess the plasma concentration of GSK2646264 for Part B on Day 1 (Pre-dose,1,4,8,12,24 hours), Day 2 (1,4,8,12,24 hours), Day 3 (1,4,8,12,24 hours), Day 6, Day 9, Day 12, Day 15 and follow-up (Day 17 to 19). The actual date and time of each blood sample collection was recorded.|Day 1 (Pre-dose,1,4,8,12,24 hours), Day 2 (1,4,8,12,24 hours), Day 3 (1,4,8,12,24 hours), Day 6, Day 9, Day 12, Day 15 and follow-up (Day 17 to 19)|PK Population|||nanograms/milliliter||Standard Deviation|Mean
2578705|NCT02424799|Secondary|Plasma GSK2646264 Pharmacokinetic (PK) Concentrations for Part A|Blood samples were collected to assess the plasma concentration of GSK2646264 for Part A on Day 1 (Pre-dose,1,2,4,8,12,24 hours), Day 2 (1,2,4,8,12,24 hours), Day 3 (1,2,4,8,12,24 hours) and Day 4 post-dose at Day 5 (30 and 36 hours), Day 6 (48,54 and 60 hours), Day 7 (72,78 and 84 hours) and Day 8 (96 hours). The actual date and time of each blood sample collection was recorded.|Day 1 (Pre-dose,1,2,4,8,12,24 hours), Day 2 (1,2,4,8,12,24 hours), Day 3 (1,2,4,8,12,24 hours) and Day 4 post-dose at Day 5 (30 and 36 hours), Day 6 (48,54 and 60 hours), Day 7 (72,78 and 84 hours) and Day 8 (96 hours)||||nanograms/milliliter||Standard Deviation|Mean
2578706|NCT02424799|Secondary|Plasma GSK2646264 Pharmacokinetic (PK) Concentrations for Part A|Blood samples were collected to assess the plasma concentration of GSK2646264 for Part A on Day 1 (Pre-dose,1,2,4,8,12,24 hours), Day 2 (1,2,4,8,12,24 hours) and Day 3 (1,2,4,8,12,24 hours). The actual date and time of each blood sample collection was recorded. PK Population comprised of all randomized participants of the Safety Population for whom a pharmacokinetic sample was obtained and analyzed.|Day 1 (Pre-dose,1,2,4,8,12,24 hours), Day 2 (1,2,4,8,12,24 hours) and Day 3 (1,2,4,8,12,24 hours)|PK Population|||nanograms/milliliter||Standard Deviation|Mean
2578707|NCT02424799|Primary|Number of Participants With Tolerability Assessment for Part C|Tolerability was assessed with the skin irritation scoring system of study, where the score consists of a numeric score according to the dermal response scoring as follows 0=no evidence of irritation, 1=minimal erythema, barely perceptible (pink), 2=moderate erythema (definite redness), 3=strong erythema (intense redness), 4=definite edema, 5=erythema, edema, and papules, 6=vesicular eruption, 7=strong reaction spreading beyond test site, and a letter according to the other effects scoring, Z=no other effect, A=slight glazed appearance, B=marked glazing, C=glazing with peeling and cracking, F=glazing with fissures, G=film of dried serous exudate covering all or part of the patch site, H=small petechial erosions and/or scabs. For each skin assessment, letter grade will be converted to numeric values as below: A=0, Z=0, B=1, C=2, F=3, G=3, H=3. A combined score for each participant was calculated by adding all numeric and letter scores. A maximum score of 3 was allowed.|Up to Day 7|Safety Population|||Participants|||Count of Participants
2578708|NCT02424799|Primary|Number of Participants With Tolerability Assessment for Part B|Tolerability was assessed with the skin irritation scoring system of study, where the score consists of a numeric score according to the dermal response scoring as follows 0=no evidence of irritation, 1=minimal erythema, barely perceptible (pink), 2=moderate erythema (definite redness), 3=strong erythema (intense redness), 4=definite edema, 5=erythema, edema, and papules, 6=vesicular eruption, 7=strong reaction spreading beyond test site, and a letter according to the other effects scoring, Z=no other effect, A=slight glazed appearance, B=marked glazing, C=glazing with peeling and cracking, F=glazing with fissures, G=film of dried serous exudate covering all or part of the patch site, H=small petechial erosions and/or scabs. For each skin assessment, letter grade will be converted to numeric values as below: A=0, Z=0, B=1, C=2, F=3, G=3, H=3. A combined score for each participant was calculated by adding all numeric and letter scores. A maximum score of 3 was allowed.|Up to Day 3||||Participants|||Count of Participants
2578709|NCT02424799|Primary|Number of Participants With Tolerability Assessment for Part A|Tolerability was assessed with the skin irritation scoring system of study, where the score consists of a numeric score according to the dermal response scoring as follows 0=no evidence of irritation, 1=minimal erythema, barely perceptible (pink), 2=moderate erythema (definite redness), 3=strong erythema (intense redness), 4=definite edema, 5=erythema, edema, and papules, 6=vesicular eruption, 7=strong reaction spreading beyond test site, and a letter according to the other effects scoring, Z=no other effect, A=slight glazed appearance, B=marked glazing, C=glazing with peeling and cracking, F=glazing with fissures, G=film of dried serous exudate covering all or part of the patch site, H=small petechial erosions and/or scabs. For each skin assessment, letter grade will be converted to numeric values as below: A=0, Z=0, B=1, C=2, F=3, G=3, H=3. A combined score for each participant was calculated by adding all numeric and letter scores. A maximum score of 3 was allowed.|Up to Day 4|Safety Population|||Participants|||Count of Participants
2578710|NCT02424799|Primary|Number of Participants With Hematology Data Outside the Range of PCI for Part C|Hematology parameters assessed were basophils (high >0.1x10^9 cells/Liter), eosinophils (high >0.44x 10^9 cells/Liter), hematocrit, hemoglobin, lymphocytes (low <0.8x10^9 cells/Liter), MCH (low <28 picograms and high >32 picograms), MCHC low <32 grams/liter and high >36 grams/liter), MCV, monocytes (high >0.208x10^9 cells/Liter), platelet count, RBC count (low <4.2x10^6 cells/microliter and high 5.9x10^6 cells/microliter) count, total neutrophils and WBC count. Values flagged as high and low of PCI for participants have been presented. Only categories with non-zero values have been presented.|Day 1, Day 7 and follow up (Day 23)|Safety Population|||Participants|||Count of Participants
2578711|NCT02424799|Primary|Number of Participants With Hematology Data Outside the Range of PCI for Part B|Hematology parameters assessed were basophils (high >0.1x10^9 cells/Liter), eosinophils (high >0.44x 10^9 cells/Liter), hematocrit, hemoglobin, lymphocytes (low <0.8x10^9 cells/Liter), MCH (low <28 picograms and high >32 picograms), MCHC (low <32 grams/liter and high >36 grams/liter), MCV, monocytes (high >0.208x10^9 cells/Liter), platelet count, RBC count (low <4.2x10^6 cells/microliter and high 5.9x10^6 cells/microliter) count, total neutrophils and WBC count. Values flagged as high and low of PCI for participants have been presented. Only categories with non-zero values have been presented.|Day 3 and follow up (Day 17 to 19)|Safety Population|||Participants|||Count of Participants
2578720|NCT02424799|Primary|Change From Baseline in Electrocardiogram (ECG) Parameters for Part A|Triplicate 12-lead ECGs were obtained at screening and during the study single ECGs were taken. At each time point during the study ECG was taken using an ECG machine that automatically calculates the heart rate and measured the PR interval, QRS duration, corrected QT (QTc-Bazett [QTcB], QTC interval-Fredericia[QTcF]) intervals, RR interval and uncorrected QT interval. Baseline was defined as assessment performed at Day -1. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Day -1) and Day 8 and follow-up (Day 9 to Day 11)|Safety Population|||milliseconds||Standard Deviation|Mean
2578712|NCT02424799|Primary|Number of Participants With Hematology Data Outside the Range of PCI for Part A|Hematology parameters assessed were basophils (high >0.1x10^9 cells/Liter), eosinophils (high >0.44x 10^9 cells/Liter), hematocrit, hemoglobin, lymphocytes (low <0.8x10^9 cells/Liter), MCH (low <28 picograms and high >32 picograms), MCHC (low <32 grams/liter and high >36 grams/liter), MCV, monocytes (high >0.208x10^9 cells/Liter), platelet count, RBC count (low <4.2x10^6 cells/microliter and high 5.9x10^6 cells/microliter) count, total neutrophils, WBC count. Values flagged as high and low of PCI for participants have been presented. Only categories with non-zero values have been presented.|Day 5, Day 7 and follow up (Day 9 to Day 11)|Safety Population|||Participants|||Count of Participants
2578713|NCT02424799|Primary|Number of Participants With Hematology Data Outside the Range of PCI for Part A|Hematology parameters assessed were basophils (high >0.1x10^9 cells/Liter), eosinophils (high >0.44x 10^9 cells/Liter), hematocrit, hemoglobin, lymphocytes (low <0.8x10^9 cells/Liter), mean corpuscle hemoglobin (MCH low <28 picograms and high >32 picograms), mean corpuscle hemoglobin concentration (MCHC low <32 grams/liter and high >36 grams/liter), mean corpuscle volume (MCV), monocytes (high >0.208x 10^9 cells/Liter), platelet count, red blood cell (RBC low <4.2x10^6 cells/microliter and high 5.9x10^6 cells/microliter) count, total neutrophils and white blood cell (WBC) count. Values flagged as high and low of PCI for participants have been presented. Only categories with non-zero values have been presented.|Day 4 and follow up (Day 5 to Day 7)|Safety Population|||Participants|||Count of Participants
2578714|NCT02424799|Primary|Number of Participants With Clinical Chemistry Data Outside the Range of PCI for Part C|Clinical chemistry parameters assessed were ALT, albumin (low <30 grams/liter), alkaline phosphatase, AST, calcium (low <2 millimoles/liter and high >2.75 millimoles/liter), chloride (low <98 millimoles/liter and high >106 millimoles/liter), creatinine (high >159 micromoles/liter), direct bilirubin, GGT (low <8 units/liter and high >78 units/liter), glucose (low <3 millimoles/liter and high >11.1 millimoles/liter), phosphorus (low 0.97 millimoles/liter and high 1.45 millimoles/liter), potassium (low <3 millimoles/liter and high >5.5 millimoles/liter), sodium (low <130 millimoles/liter and high >150 millimoles/liter), total bilirubin, total protein (low <60 grams/liter and high >78 grams/liter) and urea/BUN (low <2.9 millimoles/liter and high >7.1 millimoles/liter). Values flagged as high and low of PCI for participants have been presented. Only categories with non-zero values have been presented.|Day 1, Day 7 and follow up (Day 23)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=x in the category titles).|||Participants|||Count of Participants
2578715|NCT02424799|Primary|Number of Participants With Clinical Chemistry Data Outside the Range of PCI for Part B|Clinical chemistry parameters assessed were ALT, albumin (low <30 grams/liter), alkaline phosphatase, AST, calcium (low <2 millimoles/liter and high >2.75 millimoles/liter), chloride (low <98 millimoles/liter and high >106 millimoles/liter), creatinine (high >159 micromoles/liter), direct bilirubin, GGT (low <8 units/liter and high >78 units/liter), glucose (low <3 millimoles/liter and high >11.1 millimoles/liter), phosphorus (low 0.97 millimoles/liter and high 1.45 millimoles/liter), potassium (low <3 millimoles/liter and high >5.5 millimoles/liter), sodium (low <130 millimoles/liter and high >150 millimoles/liter), total bilirubin, total protein and urea/BUN (low <2.9 and high >7.1). Values flagged as high and low of PCI for participants have been presented. Only categories with non-zero values have been presented.|Day 3 and follow up (Day 17 to Day 19)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=x in the category titles).|||Participants|||Count of Participants
2578716|NCT02424799|Primary|Number of Participants With Clinical Chemistry Data Outside the Range of PCI for Part A|Clinical chemistry parameters assessed were alanine amino transferase (ALT), albumin (low <30 grams/liter), alkaline phosphatase, AST, calcium (low <2 millimoles/liter and high >2.75 millimoles/liter), chloride, creatinine (high >159 micromoles/liter), direct bilirubin, GGT (low <8 units/liter and high >78 units/liter), glucose (low <3 millimoles/liter and high >11.1 millimoles/liter), phosphorus (low 0.97 millimoles/liter and high 1.45 millimoles/liter), potassium (low <3 millimoles/liter and high >5.5 millimoles/liter), sodium (low <130 millimoles/liter and high >150 millimoles/liter), total bilirubin, total protein and urea/BUN). Values flagged as high and low of PCI for participants have been presented. Only categories with non-zero values have been presented.|Day 5, Day 7 and follow up (Day 9 to Day 11)|Safety Population|||Participants|||Count of Participants
2578717|NCT02424799|Primary|Number of Participants With Clinical Chemistry Data Outside the Range of Potential Clinical Importance (PCI) for Part A|Clinical chemistry parameters assessed were alanine amino transferase (ALT), albumin (low <30 grams/liter), alkaline phosphatase, aspartate aminotransferase (AST), calcium (low <2 millimoles/liter and high >2.75 millimoles/liter), chloride, creatinine (high >159 micromoles/liter), direct bilirubin, gamma glutamyl transferase (GGT low <8 units/liter and high >78 units/liter), glucose (low <3 millimoles/liter and high >11.1 millimoles/liter), phosphorus (low 0.97 millimoles/liter and high 1.45 millimoles/liter), potassium (low <3 millimoles/liter and high >5.5 millimoles/liter), sodium (low <130 millimoles/liter and high >150 millimoles/liter), total bilirubin, total protein and urea/blood urea nitrogen (BUN). Values flagged as high and low of PCI for participants have been presented. Only categories with non-zero values have been presented.|Day 4 and follow up (Day 5 to Day 7)|Safety Population|||Participants|||Count of Participants
2578718|NCT02424799|Primary|Change From Baseline in ECG Parameters for Part C|Triplicate 12-lead ECGs were obtained at screening and during the study single ECGs were taken. At each time point during the study ECG was taken using an ECG machine that automatically calculates the heart rate and measured the PR interval, QRS duration, QTcB, QTcF intervals, RR interval and uncorrected QT interval. Baseline was defined as assessment performed at Day -1. Change from Baseline was calculated as the post-dose visit value minus the Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.|Baseline (Day -1) and Day 7 (pre-dose) and follow-up (Day 23)|Safety Population|||milliseconds||Standard Deviation|Mean
2578719|NCT02424799|Primary|Change From Baseline in ECG Parameters for Part B|Triplicate 12-lead ECGs were obtained at screening and during the study single ECGs were taken. At each time point during the study ECG was taken using an ECG machine that automatically calculates the heart rate and measured the PR interval, QRS duration, QTcB, QTcF intervals, RR interval and uncorrected QT interval. Baseline was defined as assessment performed at Day -1. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Day -1) and Day 3 (pre-dose) and follow-up (Day 17 to Day 19)|Safety Population|||milliseconds||Standard Deviation|Mean
2578721|NCT02424799|Primary|Change From Baseline in Electrocardiogram (ECG) Parameters for Part A|Triplicate 12-lead ECGs were obtained at screening and during the study single ECGs were taken. At each time point during the study ECG was taken using an ECG machine that automatically calculates the heart rate and measured the PR interval, QRS duration, corrected QT (QTc-Bazett [QTcB], QTC interval-Fredericia [QTcF]) intervals, RR interval and uncorrected QT interval. Baseline was defined as assessment performed at Day -1. Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Day -1) and Day 4, and follow-up (Day 5 to Day 7)|Safety Population|||milliseconds||Standard Deviation|Mean
2578722|NCT02424799|Primary|Change From Baseline in Vital Sign SBP and DBP for Part C|Vital signs SBP and DBP were measured in the semi-supine position after 10 minutes of rest. Assessments were performed at Day 4 (pre-dose), Day 7 (pre-dose), Day 10, Day 15 and follow-up. Baseline was defined as assessments performed at Day 1 (pre-dose). Change from Baseline was calculated as the post-dose visit value minus the Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.|Baseline (Day 1 pre-dose) and Day 4 (pre-dose), Day 7 (pre-dose), Day 10, Day 15 and follow-up (Day 23)|Safety Population|||millimeters of mercury||Standard Deviation|Mean
2578723|NCT02424799|Primary|Change From Baseline in Vital Sign Parameters SBP and DBP for Part B|Vital signs SBP and DBP were measured in the semi-supine position after 10 minutes of rest. Assessments were performed at Day 2 (pre-dose), Day 3 (pre-dose), Day 6, Day 9, Day 12, Day 15 and follow-up. Baseline was defined as assessments performed at Day 1(pre-dose). Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Day 1 pre-dose) and Day 2 (pre-dose), Day 3 (pre-dose), Day 6, Day 9, Day 12, Day 15 and follow-up (Day 17 to Day 19)|Safety Population|||millimeters of mercury||Standard Deviation|Mean
2578724|NCT02424799|Primary|Change From Baseline in Vital Sign Parameters SBP and DBP for Part A|Vital signs SBP and DBP were measured in the semi-supine position after 10 minutes of rest. Assessments were performed at Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (pre-dose), Day 5, Day 6, Day 7, Day 8 and follow-up. Baseline was defined as assessments performed at Day 1 (pre-dose). Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Day 1 pre-dose) and Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (pre-dose), Day 5, Day 6, Day 7, Day 8 and follow-up (Day 9 to Day 11)|Safety Population|||millimeters of mercury||Standard Deviation|Mean
2578725|NCT02424799|Primary|Change From Baseline in Vital Sign Parameters Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part A|Vital signs SBP and DBP were measured in the semi-supine position after 10 minutes of rest. Assessments were performed at Day 2, Day 3, Day 4 and follow-up. Baseline was defined as assessments performed at Day 1 (pre-dose). Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Day 1 pre-dose) and Day 2 (pre-dose), Day 3 (pre-dose), Day 4 and follow-up (Day 5 to Day 7)||||millimeters of mercury||Standard Deviation|Mean
2578726|NCT02424799|Primary|Change From Baseline in Vital Sign Parameter Heart Rate for Part C|Vital sign heart rate was measured in the semi-supine position after 10 minutes of rest. Assessments were performed at Day 4 (pre-dose), Day 7 (pre-dose), Day 10, Day 15 and follow-up. Baseline was defined as assessments performed at Day 1(pre-dose). Change from Baseline was calculated as the post-dose visit value minus the Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.|Baseline and (Day 1 pre-dose), Day 4 (pre-dose), Day 7 (pre-dose), Day 10, Day 15, follow-up (Day 23)|Safety Population|||Beats/minute||Standard Deviation|Mean
2578727|NCT02424799|Primary|Change From Baseline in Vital Sign Parameter Heart Rate for Part B|Vital sign heart rate was measured in the semi-supine position after 10 minutes of rest. Assessments were performed at Day 2 (pre-dose), Day 3 (pre-dose), Day 6, Day 9, Day 12, Day 15 and follow-up. Baseline was defined as assessments performed at Day 1(pre-dose). Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Day 1 pre-dose) and Day 2 (pre-dose), Day 3 (pre-dose), Day 6, Day 9, Day 12, Day 15 and follow-up (Day 17 to Day 19)|Safety Population|||Beats/minute||Standard Deviation|Mean
2578728|NCT02424799|Primary|Change From Baseline in Vital Sign Parameter Heart Rate for Part A|Vital sign heart rate was measured in the semi-supine position after 10 minutes of rest. Assessments were performed at Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (pre-dose), Day 5, Day 6, Day 7, Day 8 and follow-up. Baseline was defined as assessments performed at Day 1(pre-dose). Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Day 1 pre-dose) and Day 2 (pre-dose), Day 3 (pre-dose), Day 4 (pre-dose), Day 5, Day 6, Day 7, Day 8 and follow-up (Day 9 to Day 11)|Safety Population|||Beats/minute||Standard Deviation|Mean
2578729|NCT02424799|Primary|Change From Baseline in Vital Sign Parameter Heart Rate for Part A|Vital sign heart rate was measured in the semi-supine position after 10 minutes of rest. Assessments were performed at Day 2, Day 3, Day 4 and follow-up. Baseline was defined as assessments performed at Day 1(pre-dose). Change from Baseline was calculated as the post-dose visit value minus the Baseline value.|Baseline (Day 1 pre-dose) and Day 2 (pre-dose), Day 3 (pre-dose), Day 4 and follow-up (Day 5 to Day 7)|Safety Population|||Beats/minute||Standard Deviation|Mean
2578730|NCT02424799|Primary|Number of Participants With AEs and SAEs Defined by Severity Part C|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. AE and SAE were categorized as mild=an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities, moderate=an event that was sufficiently discomforting to interfere with normal everyday activities and severe=an event that prevented normal everyday activities.|Up to 23 days|Safety Population|||Participants|||Count of Participants
2578801|NCT02423577|Primary|Frequencies of Viral Shedding|Percentage of Subjects Demonstrating Viral Shedding.|Day 2 to Day 10|The percentage of subjects demonstrating viral shedding was estimated for each treatment with corresponding asymptotic 95% confidence intervals, based on the normal approximation to the binomial distribution (Wilsons’s method)|||Participants|||Count of Participants
2578804|NCT02423447|Secondary|PRO (Patient-reported Outcome)|Investigators will question the study patients re: their tolerability and comfort after the intervention on Day 1 & Day 2 visits.|End of study visit per intervention|Patients rated comfort on a scale of 1 (most comfortable) to 10 (most un-comfortable)|||units on a scale||Full Range|Mean
2578731|NCT02424799|Primary|Number of Participants With AEs and SAEs Defined by Severity Part B|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. AE and SAE were categorized as mild=an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities, moderate=an event that was sufficiently discomforting to interfere with normal everyday activities and severe=an event that prevented normal everyday activities. Data is presented according to the percentage BSA as it impacted safety|Up to 19 days|Safety Population|||Participants|||Count of Participants
2578732|NCT02424799|Primary|Number of Participants With AEs and SAEs Defined by Severity Part A|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. AE and SAE were categorized as mild=an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities, moderate=an event that was sufficiently discomforting to interfere with normal everyday activities and severe=an event that prevented normal everyday activities.|Up to Day 11|Safety Population|||Participants|||Count of Participants
2578733|NCT02424799|Primary|Number of Participants With AEs and SAEs Defined by Severity Part A|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. AE and SAE were categorized as mild=an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities, moderate=an event that was sufficiently discomforting to interfere with normal everyday activities and severe=an event that prevented normal everyday activities.|Up to Day 7|Safety Population|||Participants|||Count of Participants
2578734|NCT02424799|Primary|Number of Participants With AEs and SAEs Part C|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to Day 23|Safety Population|||Participants|||Count of Participants
2578735|NCT02424799|Primary|Number of Participants With AEs and SAEs Part B|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Data is presented according to the percentage BSA as it impacted safety|Up to Day 19|Safety Population|||Participants|||Count of Participants
2578736|NCT02424799|Primary|Number of Participants With AEs and SAEs Part A|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to Day 11|Safety Population|||Participants|||Count of Participants
2578737|NCT02424799|Primary|Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Part A|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. Safety population comprised of all participants who took at least one dose of study treatment.|Up to Day 7|Safety Population|||Participants|||Count of Participants
2578738|NCT02424734|Secondary|Percentage of Participants With Favorable Microbiological Response|Microbiological response was determining programmatically and assessed at the participants level at EOT and TOC. Microbiological response was defined as Favorable (Eradication or Presumed Eradication), Unfavorable (Persistence or Presumed Persistence) or Indeterminate (participant's clinical response is Indeterminate and no microbiological culture data is available). Eradication defined as absence of the original baseline pathogen from the source specimen; presumed eradication was defined when source specimen was not available to culture and the participant was assessed as a clinical cure (resolution of all acute signs and symptoms of LOS or improvement to such an extent that no further antibacterial therapy was required). EOT visit occurred within 24 hours after the end of last infusion. TOC visit occurred within 8 to 15 days after last dose of study drug.|EOT visit (up to Day 15), TOC visit (up to Day 29)|Modified ITT analysis set: participants who received ceftaroline fosamil and met minimal disease criteria of late-onset sepsis (diagnosis of sepsis within 36 hours before enrolment [defined as presence of >=2 clinical criteria, >=1 laboratory criteria in presence of or as a result of suspected /proven bacterial infection that requires IV therapy).|||percentage of participants||95% Confidence Interval|Number
2578802|NCT02423447|Primary|Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / G5.|Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.|End of study visit per intervention||||percentage of predicted value||Full Range|Mean
2578803|NCT02423447|Primary|Dry Sputum Weight|To compare the wet to dry weight of study patients' sputum collected during their Day 1 & Day 2 therapy sessions.|End of study visit per intervention||||gram||Full Range|Mean
2578739|NCT02424734|Secondary|Percentage of Participants With Favorable Clinical Response|Clinical response was assessed by the investigator as Cure, Failure or Indeterminate at End of treatment (EOT) and Test of Cure (TOC). Favorable clinical response was defined as clinical response of Cure (defined as resolution of all acute signs and symptoms of Late-onset sepsis [LOS] or improvement to such an extent that no further antibacterial therapy is required). EOT visit occurred within 24 hours after the end of last infusion. TOC visit occurred within 8 to 15 days after the last dose of study therapy.|EOT visit (up to Day 15), TOC visit (up to Day 29)|Modified ITT analysis set: participants who received ceftaroline fosamil and met minimal disease criteria of late-onset sepsis (diagnosis of sepsis within 36 hours before enrolment [defined as presence of >=2 clinical criteria, >=1 laboratory criteria in presence of or as a result of suspected /proven bacterial infection that requires IV therapy]).|||percentage of participants||95% Confidence Interval|Number
2578740|NCT02424734|Secondary|Plasma Concentration of Ceftaroline M-1|Ceftaroline M-1 was the inactive metabolite of ceftaroline. Data was not summarized and provided for individual participants only and reported in this end point for only those participants who had concentrations above LOQ at any specific time-point. LOQ was 50 ng/mL|At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOI|The PK analysis set will include all participants who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected.|||ng/mL|||Number
2578741|NCT02424734|Secondary|Plasma Concentration of Ceftaroline|Ceftaroline fosamil was the prodrug of ceftaroline. Data was not summarized and provided for individual participants only and reported in this end point for only those participants who had concentrations above LOQ at any specific time-point. LOQ was 50 ng/mL|At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOI|PK analysis set included all participants who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected.|||ng/mL|||Number
2578742|NCT02424734|Secondary|Plasma Concentration of Ceftaroline Fosamil|Data was not summarized and provided for individual participants only and reported in this end point for only those participants who had concentrations above limit of quantification (LOQ). LOQ was 50 nanogram per milliliter (ng/mL).|At the end of infusion (EOI)|Pharmacokinetic (PK) analysis set included all participants who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected.|||ng/mL|||Number
2578743|NCT02424734|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to study follow-up (SFU) visit (28 to 35 days after last dose of study treatment) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline up to SFU visit (up to a maximum study duration of 49 days)|Safety analysis set consisted of all enrolled participants for whom informed consent form was signed and received any amount of ceftaroline fosamil.|||Participants|||Count of Participants
2578744|NCT02424591|Secondary|Beck's Depression Inventory|"Beck's Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures attitudes and symptoms of depression. Each sentence has a rating from 0 to 3 and the sentences go from mild to fairly severe descriptions of moods. The numbers are tabulated, the lowest possible score is 0 and the highest is 63.~A score of 1-10 indicates normal ups and downs. 11-16 indicates a mild mood disturbance; 17-20, borderline clinical depression; 21-30, moderate depression; 31-40, severe depression; over 40, extreme depression"|Post-op Day 3||||points||Inter-Quartile Range|Median
2578745|NCT02424591|Secondary|Pain Score|"McGill Short Form measures pain in different ways. The first part of the form lists 15 adjectives for pain, for which the answers can be none (0), Mild (1), Moderate (2) and Severe (3). Descriptors 1-11 represent the sensory dimension of pain experience and 12-15 represent the affective dimension. A score of 0 is good, and a score of 45 indicates extreme pain. The lower the score the less pain a subject feels (better), as the scores go up, so do the pain levels (worse).~PPI (Present Pain Intensity) asks patients to measure pain from 0 (no pain) to 5 (excruciating). Again, a lower score is ideal."|Post-op Day 3||||points||Inter-Quartile Range|Median
2578746|NCT02424591|Primary|Scores on Questionnaires|Quality of Recovery 15 questions questionnaires that ask, on a scale of 0-10, with 0 always being bad and 10 always being best, how the patient is recovering. The total number is reviewed, so the highest total score possible is 150 and the lowest is 0.|Post-op Day 3||||points||Inter-Quartile Range|Median
2578747|NCT02424578|Secondary|Safety of Diclofenac Capsules Low Dose and High Dose as Assessed by the Incidence of Adverse Events From Baseline to Day 3 or Early Termination||Baseline to Day 3/Early Termination|||||||
2578748|NCT02424578|Primary|Plasma Concentration of Diclofenac|The estimated typical value for clearance (tvCl) following a single diclofenac dose based on population pharmacokinetic (PopPK) modeling using sparse plasma concentration data in pediatric subjects.|0-6 hours after first dose of diclofenac|Pharmacokinetic (PK) population. Defined as all subjects who received at least one dose of study drug and had at least one quantifiable plasma diclofenac concentration after dosing.|||mL/hr||Standard Error|Mean
2578760|NCT02424539|Secondary|Mean Change From Baseline in the Daily rTOSS Over the 4 Weeks Treatment Period|"TOSS is a composite score of the three components (eye itching and burning, eye watering and eye redness) with a total score of 0 to 9. Higher score means a worse symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). The daily scores were averaged to calculate the overall/total score. Participants were instructed to provide scores and document their symptoms in a reflective manner twice daily using their diary at the same time of reflective nasal symptoms assessment. Baseline scores obtained over 4 days prior to randomization were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value."|Baseline and up to Week 4|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2582082|NCT02384200|Secondary|Positive Bladder Urine Culture|bladder urine culture taken during kidney stone surgery|once, within 30 minutes of start of surgery||||Participants|||Count of Participants
2578749|NCT02424565|Primary|Time to Significant Increase in Local Surface Temperature|Local surface temperature was measured by the spectral order of colour after application of product. Infra-red camera was used to take 11 images with one just before application of product and remaining 10 images at every minute for first 10 minutes after application of product. IR camera converted the IR energy radiated by the body into electrical impulses, which were then digitally indicated on a spatial temperature map. IR camera represents the temperature distribution in a so-called rainbow or spectral order of colors. The predominant colour will be determined on a 5 point scale based on Thermal Images produced using Infra-Red Thermography (IRT) technique and recorded as either Blue, Green, Yellow, Orange or Deep Orange/Red (In increasing order of temperature). There was an approximate temperature difference of 0.5°C between adjacent colours on the map which was supposed to brought about by application of the product and considered significant.|Every minute from baseline to 10 minutes|Intent-to-treat (ITT) population included all participants of safety population with any post-treatment assessment. Since no significant increase in surface temperature was observed in subjects for either treatment, therefore, number of subjects analyzed for this outcome is zero.||||||
2578750|NCT02424539|Secondary|Change From Baseline in Respiration Rate|Vital signs including respiration rate were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed.|Baseline and Week 4|ITT Population|||Breaths per minute||Standard Deviation|Mean
2578751|NCT02424539|Secondary|Change From Baseline in Temperature|Vital signs including temperature were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed.|Baseline and Week 4|ITT Population|||Degree Celsius||Standard Deviation|Mean
2578752|NCT02424539|Secondary|Change From Baseline in Heart Rate|Vital signs including heart rate were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed.|Baseline and Week 4|ITT Population|||Beats per minute||Standard Deviation|Mean
2578753|NCT02424539|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital signs including SBP and DBP were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed.|Baseline and Week 4|ITT Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2578754|NCT02424539|Secondary|Number of Participants With Change From Baseline in Nasal Examination|A detailed nasal examination of the mucosa, septum, secretions, nasal patency, size of any polyps and ulcers was performed at specific time points. Number of participants with improved or worsened conditions are presented. Improved condition was defined as increase in number of patencies and Worsened condition was defined as decrease in number of patencies, from Baseline to Week 4. The Baseline value for a nasal examination was the most recent recorded value for Week 4 before dosing on Day 1. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and Week 4|ITT Population|||Participants|||Number
2578755|NCT02424539|Secondary|Number of Participants With Urinalysis Values Outside Normal Range|Urine parameters including urine specific gravity and urine potential of hydrogen (pH) with values outside normal range is presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Week 4|ITT Population|||Participants|||Number
2578756|NCT02424539|Secondary|Number of Participants With Hematology Values Outside Normal Range|Blood samples were collected from participants at indicated time points to evaluate hematology values outside normal range. The hematology parameters including basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes, platelet, red blood cells (RBC), total neutrophils, white blood cells (WBC) with values outside normal range is presented. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|Week 4|ITT Population|||Participants|||Number
2578757|NCT02424539|Secondary|Number of Participants With Clinical Chemistry Values Outside the Normal Range|Blood samples were collected from participants at indicated time points to evaluate clinical chemistry values outside normal range. The clinical chemistry parameters including alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, creatinine, direct bilirubin, glucose, potassium, sodium, total bilirubin, total protein and blood urea nitrogen (BUN) with values outside normal range is presented. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Week 4|ITT Population|||Participants|||Number
2578758|NCT02424539|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs During the Treatment Period|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function.|Up to Week 4|ITT Population|||Participants|||Number
2578759|NCT02424539|Secondary|Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 4 Weeks Treatment Period|Loratadine was provided as a rescue medication to use if needed throughout the study treatment period. Participants were asked to document loratadine rescue medication use on the daily treatment diary. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and up to Week 4|ITT Population|||Days||Standard Error|Least Squares Mean
2579242|NCT02418026|Secondary|Wellbeing Measured Using a Comfort Scale|"The comfort scale is a numeric rating scale ranging from 0 to 10 : 0 corresponds to no comfort and 10 corresponds to most comfortable."|Day 2||||units on a scale||Standard Deviation|Mean
2578761|NCT02424539|Secondary|Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 4 Weeks|The nasal concha mucosa symptoms score was used to evaluate change in anterior rhinoscopy. It is a composite score of four components including swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume and description of rhinorrhea. Severity of each of the component was assessed using the scale ranging from 0 (no symptom) to 3 (severe). The 4 components were averaged to obtain a total score which ranges from 0 to 12 where a higher score means a worse nasal symptom. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified time points were included in the analysis.|Baseline and up to Week 4|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2578762|NCT02424539|Secondary|Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale|Response was defined as effectiveness of study medication for relieving allergic rhinitis symptoms over the entire treatment period. Overall response to therapy was evaluated using the 7-point categorical scale ranging from 1 (significantly improved) to 7 (significantly worse). Number of participants showing response to therapy after the first 4 weeks have been presented. Only those participants with response to therapy over the entire treatment period were included in the analysis.|Week 4|ITT Population|||Participants|||Number
2578763|NCT02424539|Secondary|Mean Change From Baseline in Daily rTNSS Over the 4 Weeks Treatment Period|"TNSS is a composite score of the four components (nasal congestion, itching, rhinorrhea and sneezing) with a total score of 0 to 12. A higher score means a worse nasal symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). Participants were instructed to provide scores in a reflective manner using their diary. The daily rTNSS was the average of the morning rTNSS and evening rTNSS assessments. The daily scores were averaged to calculate the overall/total score. The morning reflective assessment was performed prior to administering the morning dose. The evening reflective assessment was performed approximately 12 hours after dosing but before bedtime. Baseline scores obtained over 4 days prior to randomization were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value."|Baseline and up to Week 4|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2578764|NCT02424539|Secondary|Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 2 Weeks Treatment Period|Loratadine was provided as a rescue medication to use if needed throughout the study treatment period. Participants were asked to document loratadine rescue medication use on the daily treatment diary. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value.|Baseline and up to Week 2|ITT Population|||Days||Standard Error|Least Squares Mean
2578765|NCT02424539|Secondary|Mean Change From Baseline Over the First 2 Weeks in the Daily, Reflective Total Ocular Symptoms Score (rTOSS)|"TOSS is a composite score of the three components (eye itching and burning, eye watering and eye redness) with a total score of 0 to 9. Higher score means a worse symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). The daily scores were averaged to calculate the overall/total score. Participants were instructed to provide scores and document their symptoms in a reflective manner twice daily using their diary at the same time of reflective nasal symptoms assessment. Baseline scores obtained over 4 days prior to randomization were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value"|Baseline and up to Week 2|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2578766|NCT02424539|Secondary|Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 2 Weeks|The nasal concha mucosa symptoms score was used to evaluate change in anterior rhinoscopy. It is a composite score of four components including swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume and description of rhinorrhea. Severity of each of the component was assessed using the scale ranging from 0 (no symptom) to 3 (severe). The 4 components were averaged to obtain a total score which ranges from 0 to 12 where a higher score means a worse nasal symptom. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified time points were included in the analysis.|Baseline and up to Week 2|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2578767|NCT02424539|Secondary|Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale|Response was defined as effectiveness of study medication for relieving allergic rhinitis symptoms over the entire treatment period. Overall response to therapy was evaluated using the 7-point categorical scale ranging from 1 (significantly improved) to 7 (significantly worse). Number of participants showing response to therapy after the first 2 weeks have been presented. Only those participants with response to therapy over the entire treatment period were included in the analysis.|Week 2|ITT Population|||Participants|||Number
2578768|NCT02424539|Primary|Mean Change From Baseline in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over the First 2 Weeks Treatment Period|"TNSS is a composite score of the four components (nasal congestion, itching, rhinorrhea and sneezing) with a total score of 0 to 12. A higher score means a worse nasal symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). Participants were instructed to provide scores in a reflective manner using their diary. The daily rTNSS was the average of the morning rTNSS and evening rTNSS assessments. The daily scores were averaged to calculate the overall/total score. The morning reflective assessment was performed prior to administering the morning dose. The evening reflective assessment was performed approximately 12 hours after dosing but before bedtime. Baseline scores obtained over 4 days prior to randomization were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value."|Baseline and up to Week 2|Intent-To-Treat (ITT) Population comprised of all randomized participants who received at least one dose of study treatment.|||Scores on a scale||Standard Error|Least Squares Mean
2601682|NCT02150837|Secondary|Hip Circumference|Hip circumference expressed as an absolute change from baseline.|4 weeks||||Inches||Standard Deviation|Mean
2578769|NCT02424357|Secondary|Identification of Bacterial Species Cultured From Suture Material|The collected sutures will be monitored for bacterial growth for up to 7 days. When bacterial growth is observed, 1 mL of the solution will be inoculated on chocolate, MacConkey, and anaerobic blood agars and incubated for an additional 24 to 48 hours to identify organisms and quantify growth. In vitro susceptibility patterns will be determined.|7 days plus 24 to 48 hours|All 65 participants were analyzed: 53 sutures had positive cultures (34 of the adjustable sutures and 19 of the control sutures). The relative risk between the two treatment arms indicated no difference in colonization rate, the bacterial species were not analyzed separately. Three of the sutures yielded 2 bacterial species.|||number of positive bacterial isolates|sutures||Number
2578770|NCT02424357|Secondary|Reduction of Contamination Rate Using Post-operative 5% Povidone Iodine|Comparison of suture colonization rates with and without instillation of a drop of povidone-iodine at surgery completion|48 hours||||relative risk|sutures|95% Confidence Interval|Number
2578771|NCT02424357|Primary|Suture Colonization Rate in Adjustable Suture Strabismus Surgery|1 cm section of the suture proximal to the knot will be harvested and placed in a tube with 2 ml of trypticase soy broth (TSB).The TSB tubes will be monitored for growth of bacteria at 48 hours|48 hours||||percentage sutures positive for bacteria|sutures||Number
2578772|NCT02424344|Secondary|Percentage of Inactive Patients (Mean of <6000 Steps Per Day) at Week 8|"Physical activity was assessed by means of measurement of activity parameters (e.g. number of steps) through a Dynaport MoveMonitor and completion of the Daily ProActive Physical Activity in chronic obstructive pulmonary disease (COPD) questionnaire.~Compliant criterion based on at least 8 hours per day, and at least 3 days per week. Participants underwent a behavioural intervention (consisting of a telecoaching programme to enhance physical activity) between Week 4 and Week 8.~Baseline was defined as mean of steps/day assessed during the week before the randomisation visit."|Week 8|"The intent-to-treat (ITT) population - equal to the Safety population and defined as all randomised patients who took at least one dose of IP~- who had available activity data (compliant criterion)."|||Percent of inactive participants|||Number
2578773|NCT02424344|Secondary|Change From Baseline in Endurance Time (ET) During Constant Work Rate Cycle Ergometry at Week 8|"The ET was the time from the increase in work rate to 75% Wmax to the point of symptom limitation.~Baseline measurements were taken prior to the IP dose on Day 1. Measurements at Week 8 were taken at 3 hours post-dose. Participants underwent a behavioural intervention (consisting of a telecoaching programme to enhance physical activity) between Week 4 and Week 8."|Baseline to Week 8|Intention-to-treat population - which was equal to the safety population, defined as all participants who took at least one dose of investigational product - who had available ET values at baseline and Week 8.|||Seconds||Standard Error|Least Squares Mean
2578774|NCT02424344|Primary|Change From Baseline in Trough Functional Residual Capacity (FRC) After 4 Weeks of Treatment|Baseline values in FRC were defined as the corresponding values just before randomization on Day 1 of treatment (Week 0). Trough values were obtained prior to study drug administration.|Baseline and Week 4|The intent-to-treat (ITT) population - equal to the Safety population and defined as all randomised patients who took at least one dose of investigational product (IP) - who had available trough FRC values at baseline and Week 4.|||Liters||Standard Error|Least Squares Mean
2578775|NCT02424175|Secondary|Microbiome|Number of patients that experienced changes in the microbiome post FMT. Measured as similarity to the donor microbiome post FMT compared to their baseline sample|6 months||||Participants|||Count of Participants
2578776|NCT02424175|Primary|Comparison of Alkaline Phosphatase Pre and Post Transplant|The primary clinical study end point is the number of patients that achieve a 50% or more decrease serum alkaline phosphatase|Baseline and 6 months||||Participants|||Count of Participants
2578777|NCT02424175|Primary|Adverse Event Frequency|Number of patients with reporting adverse events irregardless of severity|6 months||||Participants|||Count of Participants
2578778|NCT02424149|Secondary|Trial of Void Results|Number of subjects that failed a back-filled trial of void on the day of hospital discharge, up to 2 days after surgery.|Day of hospital discharge|For this outcome, 96 participants were analyzed. Of the 104 participants that completed the study, only 96 underwent a trial of void.|||participants who failed trial of void|||Number
2578779|NCT02424149|Secondary|Post-operative Urethral Discomfort Measured by Pain Scales|Measured prior to catheter removal using a 10 point visual analog pain scale: Zero represented no pain, Ten represented the most severe pain.|post operative day 1||||units on a scale||Standard Deviation|Mean
2578780|NCT02424149|Secondary|Additional Interventions: Measured by Use of IV Fluids, IV Lasix, IV Methylene Blue, or Ureteral Stent Placement in OR|this is a composite measure and will be reported as a single value for each arm as number of additional interventions|day of surgery (day 0)||||interventions|||Number
2578781|NCT02424149|Secondary|Physician Confidence Measured by a Survey|"Surgeon response to the question: I am confident that ureteral injury was ruled out in this patient on a 5-point Likert scale where 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree"|day of surgery (day 0)||||units on a scale||Standard Deviation|Mean
2578782|NCT02424149|Primary|Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room|Timing was performed in the operating room. Time to visualize urine efflux was started at insertion of the cystoscope into the bladder, the time was considered complete when both ureteral orifices had displayed urine efflux.|Day of surgery||||seconds||Standard Deviation|Mean
2578783|NCT02424097|Other Pre-specified|Change in Quantitative Light Fluorescence (QLF)|Quantitative Light Fluorescence will be used to evaluate the WSL|Baseline and 12-months|||||||
2578784|NCT02424097|Other Pre-specified|Change in SOPROLIFE|fluorescence measurements using blue light fluorescence make WSLs visible for scoring;|Baseline and 12-months|||||||
2578785|NCT02424097|Other Pre-specified|Change in Lesion Activity, Nyvad Criteria|WS lesion activity will be determined using the Nyvad criteria;|Baseline and 12-months|||||||
2578799|NCT02423798|Primary|Consensus Error Grid Analysis of Paired Sensor and Reference Plasma Glucose Values|"All analysis performed using the Consensus Error Grid (or Parkes error grid) comparing the paired sensor and YSI reference glucose values.~Zone A is defined in the Parkes error grid as the zone of clinical accurate measurements with no effect on clinical action. Zone B as altered clinical action with little or no effect on clinical outcome.. Ideal situation is 100% in Zone A + B."|4 months||||percentage|||Number
2578786|NCT02424097|Secondary|Change in International Caries Detection and Assessment System (ICDAS II) to Score for Smooth Surfaces White Spot Lesions (WSL)|"The International Caries Detection and Assessment System (ICDAS II) is a standardized method of caries lesion assessment.The score is based on apparent lesion severity, with scores from 0 to 6.The buccal surface of each tooth was divided into 4 quadrants, and for each quadrant a score was assigned with ICDAS scores: 0 = sound, 1 = first visual change in enamel, after air drying, 2 = distinct demineralization visual change in enamel, 3 = localized enamel breakdown due to caries with no visible dentin, 4 = surface with underlying dark shadow from dentin with or without enamel breakdown, 5 = distinct cavity with visible dentin, 6 = extensive cavity with visible dentin.~The ICDAS scores were calculated as the sum of the highest ICDAS scores assigned to each examined tooth per subject. 16 teeth per subject were evaluated, thus, for each subject the value can range between 0 and 96.~A mean over all participants in one group was calculated. A higher score means a worse outcome."|Baseline and 12-months||||score on a scale||Standard Deviation|Mean
2578787|NCT02424097|Primary|Change in White Spot Lesions Count - Enamel Decalcification Index (EDI)|"The area evaluation scheme of the Enamel Decalcification Index (EDI) divides the buccal surface of each tooth into 4 quadrants and then registers the possible existence of a white spot lesion (decalcification) in each of these 4 quadrants. For each quadrant the lesion can be scaled as: 0 = no decalcification, 1 = decalcification covering <50% of the area, 2 = decalcification covering > 50% of the area, 3 = decalcifications covering 100% of the area or severe decalcification with cavitation. Thus, for each tooth the value can range between 0 and 12.~16 teeth per subject were evaluated, for each subject the value of each tooth was added - thus the range per one subject can be between 0 and 192.~A mean over all participants in one group was calculated. A higher score means a worse outcome."|Baseline and 12-months|enamel decalcification index (EDI)|||units on a scale||Standard Deviation|Mean
2578788|NCT02423993|Secondary|Quality of Life (SF36 Questionnaire)|"We assessed QoL changes during the study and differences of these changes between groups.~SF-36 questionnaire enabling evaluation of patient's satisfaction with his health status and certain emotional characteristics. 36 items of the Questionnaire are grouped in 8 scales. Each scale ranges from 0 to 100, the latter representing full health."|4 months after CSII initiation|Patients from structured education group completed the QoL Questionnaires prior to education and 4 months after transferring to CSII. Patients from the control group completed (standart education) the Questionnaires during the enrollment.|||units on a scale||Inter-Quartile Range|Median
2578789|NCT02423993|Secondary|Treatment Compliance ( Frequency of SMBG and Bolus Calculator Use)|Treatment compliance evaluation was based on frequency of SMBG and bolus calculator use as one of the factors mediating achievement of target plasma glucose level.|within 4 month of the study||||events||Standard Deviation|Mean
2578790|NCT02423993|Secondary|Glycaemic Variability|"Several glucose variability scores was assessed: SD, MAGE, MODD, LI, HBGI, LBGI, MAG. For SAP users glucose variability scores were calculated from CGM data. For CSII users with SMBG only glucose variability scores were calculated from bolus calculator (Bolus Wizard) data."|within 4 month of the study||2015-11-30|11/2015||||
2578791|NCT02423993|Secondary|Nonsevere Hypoglycaemia Frequency|Nonsevere hypoglycemia is defined аs an episode of a blood glucose value of less than 70 mg per deciliter (3.9 mmol per liter). All hypoglycaemia episodes was reported in patients dairies and then will be assessed and compared between groups.|within 4 month of the study||||events per day||Standard Deviation|Mean
2578792|NCT02423993|Secondary|Quality of Life (ADDQoL Questionnaire)|"Will be assessed QoL changes during the study and differences of these changes between groups.~ADDQoL Questionnaire includes 2 general scales and 18 specific scales. 2 general scales represent the general QoL and diabetes - dependent QoL (scales varies from -3 (worse) to +3 (better)). 18 specific scales represent the impact of diabetes on certain QoL parameters: working life, family life, social life, sex life, physical appearance, do physically, leisure, travel, confidence in ability, motivation, society reaction, future, finances, dependence, living conditions, freedom to eat, other's , freedom to drink. All scales varies from -9 (worse) to +9 (better)."|4 month after CSII initiation|Patients from structured education group completed the QoL Questionnaires prior to education and 4 months after transferring to CSII. Patients from the control group completed (standart education) the Questionnaires during the enrollment.|||units on a scale||Standard Deviation|Mean
2578793|NCT02423993|Secondary|Severe Hypoglycaemia Frequency|Severe hypoglycemia is defined аs an episode requiring assistance and will be confirmed by documentation of a blood glucose value of less than 50 mg per deciliter (2.8 mmol per liter) or recovery with restoration of plasma glucose.|within 4 month of the study||||events per month||Standard Deviation|Mean
2578794|NCT02423993|Primary|HbA1c|HbA1c was determined by ion exchange chromatography on an automatic biochemical analyzer Bio-RAD D-10 (France), under the manufacturer's standard procedure.|4 month after CSII initiation|"The analysis was per protocol. Patients from group education groups were on MDI regymen and from standart education group were on insulin pump therapy during previously 4 months"|||percentage||Inter-Quartile Range|Median
2578795|NCT02423980|Secondary|Time to Resolution of Induced Hypoglycemia Symptoms|Prior to and every 5 minutes after treatment, subjects were asked to rate the severity of each of 8 symptoms on a scale from 1 to 6, with 1 indicating the symptom was absent and 6 indicating the symptom was severe. The sum of the scores for the 8 individual symptoms was reported as the total hypoglycemia symptom score, which ranged from 8-48. The first time point post-treatment at which total hypoglycemia symptom score = 8 (i.e., all symptoms were absent) was considered the time to resolution. One and two subjects were unevaluable for response to the 1 mg and 0.5 mg doses of glucagon, respectively, as they reported no symptoms (i.e., total symptom score = 8) prior to treatment.|0-30 minutes|Subjects with symptoms of hypoglycemia at time of treatment|||minutes||Full Range|Median
2578796|NCT02423980|Secondary|Time to Plasma Glucose > 70 mg/dL|Following treatment, plasma glucose was measured every 5 minutes. The first such measurement at which plasma glucose concentration was observed to be >70 mg/dL was reported as the time to response.|0-90 minutes|All treated subjects|||minutes||Full Range|Median
2578797|NCT02423980|Primary|Number of Subjects With Plasma Glucose > 70 mg/dL at 30 Minutes Post-treatment|For 90 minutes following treatment, plasma glucose was measured every 5 minutes, with an increase in plasma glucose to >70 mg/dL within 30 minutes of treatment being considered a positive response.|0-90 minutes|All treated subjects|||participants with positive response|||Number
2578798|NCT02423798|Primary|Sensor Survival|sensor survival in hours|4 months||||hours||95% Confidence Interval|Mean
2578805|NCT02423447|Secondary|Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / G5.|Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.|End of study visit per intervention||||percentage of predicted value||Full Range|Mean
2578806|NCT02423447|Primary|Wet Sputum Weight|To compare the wet to dry weight of study patients' sputum collected during their Day 1 & Day 2 therapy sessions.|End of study visit per intervention||||gram||Full Range|Mean
2578807|NCT02423408|Secondary|Number of Subjects With at Least a Two-category Improvement From Baseline at 2 Hours Post-dose in VAS Severity Category (Carvalho Responders)|"The Carvalho Responder analysis refers to subjects with at least 2 categories of improvement in their VAS severity category (0-100 scale). VAS severity categories were defined as severe if between 52-100 inclusive, moderate between 31-51 inclusive, mild between 6-30 inclusive, and pain-free if less than 6. Therefore, a Carvalho responder was either a subject who had a VAS response classified as 'severe' at baseline and 'mild' or pain-free at the post-dose assessment time point, or a subject who had a VAS response classified as 'moderate' at baseline and pain-free at the post-dose assessment time point."|2 hours|"Only subjects who were categorized as severe or moderate at baseline and have data reported at 2 hours were included in this analysis. All subjects who took rescue medication at or before 2 hours were considered non-responders."|||Participants|||Count of Participants
2578808|NCT02423408|Secondary|Number of Subjects Using Rescue Medication During the 24-hour Post-dose Period||24-hour post-dose period|8 subjects in the TNX-201 group and 10 subjects in the placebo group who did not take a dose during the double-blind treatment period and/or did not report data 2-hour post-dose were excluded from analyses.|||Participants|||Count of Participants
2578809|NCT02423408|Secondary|Number of Subjects Pain Free at 15, 30, 60, 90 Minutes and 4 Hours Post-dose (Pain Will be Assessed by 4-point NRS, VAS, and Binary Yes/no Question)|"4-point NRS grades: 0=none, 1=mild, 2=moderate, 3=severe.~VAS: 0-100 scale, No Pain vs. Worst Imaginable Headache Pain"|15, 30, 60, 90 minutes and 4 hours post-dose|"LOCF Analysis~8 subjects in the TNX-201 group and 10 subjects in the placebo group who did not take a dose during the double-blind treatment period and/or did not report data 2-hour post-dose were excluded from analyses."|||Participants|||Count of Participants
2578810|NCT02423408|Primary|Number of Subjects Pain Free|"Number of subjects pain free at 2 hours post-dose (Pain assessed by 4-point NRS, VAS, and binary yes/no question).~4-point NRS grades: 0=none, 1=mild, 2=moderate, 3=severe; pain-free defined as score = 0.~VAS: 0-100 scale, anchored by verbal anchors of No Pain (0) vs. Worst Imaginable Headache Pain (100). Pain-free was defined as a score <= 5"|2 hours|"LOCF Analysis~8 subjects in the TNX-201 group and 10 subjects in the placebo group who did not take a dose during the double-blind treatment period and/or did not report data 2-hour post-dose were excluded from analyses."|||Participants|||Count of Participants
2578811|NCT02423317|Secondary|Number of Participants With Airway Trauma|Airway trauma was defined as blood detected on the blades of laryngoscopes, blood on endotracheal tube after extubation or tongue-lip-dental trauma.|5 minutes||||participants|||Number
2578812|NCT02423317|Secondary|Number of Esophageal Intubation.|Insertion of tracheal tube inside the esophagus|5 minutes||||esophageal intubation|||Number
2578813|NCT02423317|Secondary|Overall Intubation Success Rate.|It is the number of participants who were successfully intubated after first, second or third attempts. Success of intubation is defined as placement of endotracheal tube inside the trachea, confirmed by bilateral chest auscultation and square wave capnograph tracing.|5 minutes||||participants|||Number
2578814|NCT02423317|Secondary|Percentage of Glottic Opening Scoring.|The Percentage of glottic opening score represents the percentage of glottic opening seen, defined by the linear span from the anterior commissure to the interarytenoid notch|5 minutes||||percentage of glottic opening||Inter-Quartile Range|Median
2578815|NCT02423317|Secondary|Ease of Intubation.|The intubating anaesthesiologist graded the ease of intubation for both techniques on a visual analogue scale from 1 to 10, 10 being most difficult or failed intubation and 1 being very easy intubation.|5 minutes||||scores on visual analogue scale||Inter-Quartile Range|Median
2578816|NCT02423317|Secondary|Number of Intubation in First Attempts;|A single insertion of the Airtraq or a single insertion of the Miller laryngoscope blade into the mouth with passing the endotracheal tube beyond the glottis was considered as an attempt.|5 minutes||||Intubations|||Number
2578817|NCT02423317|Primary|Time to Intubation|It is defined as the time from placement of Airtraq or Miller laryngoscope into the mouth till appearance of the capnograph waveform|5 minutes||||seconds||Standard Deviation|Mean
2578818|NCT02423291|Primary|Overall Objective Response Rate in Patients With Relapsed or Refractory PMLBCL|"The antitumor efficacy of single-agent Brentuximab vedotin (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in patients with relapsed or refractory primary mediastinal large B-cell lymphoma was determined using Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-586.Treatment response was assessed by dedicated spiral CT scan of neck, chest, neck, abdomen, and pelvis and PET scans performed at protocol-specified time points. Clinical response of progressive disease (PD), stable disease (SD), partial remission (PR), or complete remission (CR) will be determined at each assessment."|42 months|Trial was closed due to drug inefficacy on 14/Jul/2016 (last enrollment on 30/Jun/2015). Details in the Outcome Measure Data Table.|||Participants|||Count of Participants
2578819|NCT02423200|Secondary|Episodic Memory Function|Total Recall in Hopkins Verbal Learning Test (HVLT). Range is 0-36, with increases in score indicating improvement in cognitive function.|Change from baseline to Day 42|As there was only one subject in the 125 mg dose group (see Pre-Assignment Details), and the blood concentration levels in this subject was similar to that in 125 mg dose group, this subjects data was combined with the 40 mg dose group in all outcome measure analyses. In addition, one subject did not have a Day 42 HVLT-R analysis.|||points on HLVT Total Recall (range 0-36)||Standard Deviation|Mean
2578962|NCT02421510|Secondary|Change From Baseline in Body Weight at Week 24|Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative change from baseline indicates a loss in body weight from baseline to Week 24.|Baseline to Week 24|Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||Kilograms (kg)||Standard Error|Least Squares Mean
2578820|NCT02423200|Secondary|Maximal CSF VX-745 Concentration|Ratio fo CSF to plasma drug concentration at time matched time points. Samples taken|All samples with quantifiable CSF drug levels were included (n=12). Eight were obtained 3-hours post-dose, either on Day 1 (n=4) or Day 42 (n=4). 3 samples were at 6-hours post-dose on Day 42; and one was at 6-hours post-dose on Day 1.|As there was only one subject in the 125 mg dose group (see Pre-Assignment Details), and the blood concentration levels in this subject was similar to that in 125 mg dose group, this subjects data was combined with the 40 mg dose group in this analysis.|||ratio of plasma drug concentration||Standard Deviation|Mean
2578821|NCT02423200|Secondary|Severe or Serious Adverse Events|Number of patients with severe or serious adverse events|At baseline and at each study visit during (days 1, 7, 14, 21, 28, 35 and 42) and after (day 51) dosing||||Participants|||Count of Participants
2578822|NCT02423200|Primary|Percent Change From Baseline to End of Treatment in Cerebrospinal Fluid Levels of Cytokines|Cytokines: Of nine cytokines assessed, only CSF IL-8 quantifiable at all time points. And so, only IL-8 levels are being reported herein. The analysis was exploratory and no statistical analysis was performed.|Baseline and Day 42 of dosing with VX-745|As there was only one subject in the 125 mg dose group (see Pre-Assignment Details), and the blood concentration levels in this subject was similar to that in 125 mg dose group, this subjects data was combined with the 40 mg dose group in this analysis. In addition, two subjects did not have Day 42 CSF samples available for analysis|||percentage of baseline at Day 42||Standard Deviation|Mean
2578823|NCT02423122|Secondary|Wechsler Memory Scale (WMS) Delayed Recall Composite|WMS delayed-recall composite score at each testing sessions consisted of the sum of the scores on Logical Memory II, Verbal Paired Associates II, and Visual Reproduction II. The composite score ranges from 0 to 136; with higher scores indicating better performance.|Change from baseline to Day 84|All patients with baseline and day 84 WMS testing data. One subject in 40 mg dose group did not complete the Day 84 WMS assessment after having developed MRI-induced panic attack.|||units on a scale||Standard Deviation|Mean
2578824|NCT02423122|Secondary|Wechsler Memory Scale (WMS) Immediate Recall Composite|WMS immediate-recall composite score consisted of the sum of the scores on Logical Memory I, Verbal Paired Associates I, and Visual Reproduction I. The composite score ranges from 0 to 136; with higher score indicating better performance.|Baseline to Day 84|All patients with baseline and day 84 WMS testing data. One subject in 40 mg dose group did not complete the Day 84 WMS assessment after having developed MRI-induced panic attack.|||units on a scale||Standard Deviation|Mean
2578825|NCT02423122|Primary|Number of 11C-PiB Responders|Number of patients meeting protocol pre-specified definition of response: > 7% reduction in global cortical BPND|Day 84|All patients with baseline and Day 84 11C-PiB scan. One patient in 40 mg dose group could not cooperate for Day 84 PET scan due to having developed MRI-induced panic attack.|||Participants|||Count of Participants
2578826|NCT02423122|Primary|Percent Change From Baseline in Amyloid Plaque Burden by 11C-PiB PET|Percent change in global cortical amyloid specific PET signal (BPND)|Baseline compared to following 12 weeks' dosing with VX-745|All patients with baseline and Day 84 11C-PiB scan. One patient in 40 mg dose group could not cooperate for Day 84 PET scan due to having developed MRI-induced panic attack.|||percentage change from baseline||Inter-Quartile Range|Median
2578827|NCT02423109|Primary|Comfort Preference|Subjective assessment for comfort preference for each lens pair. Choices: fanfilcon A lens, enfilcon A lens, No preference.|Dispensing (Baseline) and 2 weeks|Analysis population differs slightly due to protocol deviation.|||Participants|||Count of Participants
2578828|NCT02423109|Primary|Comfort (Subjective Rating Scale)|Participant rating for comfort at dispense visit and at the 2 week follow-up on a subjective rating scale (0-100, 0=cannot be worn. Causes pain,100=Cannot be felt ever)|Dispensing (Baseline) and 2 weeks|Analysis population differs slightly due to 1 participant who was excluded from analysis due to a protocol deviation.|||units on a scale||Standard Deviation|Mean
2578829|NCT02422940|Secondary|Change From Baseline on the 12-item Health Survey (SF-12)|"The SF-12 v2 (4-week recall) is a general health-related quality-of-life profile measure consisting of 12 items. The SF-12 Physical Component Summary (PCS) and the Mental Component Summary (MCS) scores will be derived and normed to a general United States population for score algorithm. The normalized PCS and MCS scores will be calculated at baseline, Month 12, and subsequent visits.~SF-12 is a Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Day 1, up to 12 months|The study was conducted in patients with chronic walking deficits from an ischemic stroke.|||score on a scale||Standard Deviation|Mean
2578830|NCT02422940|Secondary|Subject Global Impression (SGI)|"The Subject Global Impression (SGI) is single item measure of treatment response that asks the subject to rate the effects of the investigational drug on his or her overall walking ability using a 7 point scale ranging from 1 = Terrible to 7 = Delighted."|Visit 8 (Month 12)|The study was conducted in patients with chronic walking deficits from an ischemic stroke. These were the only participants to finish the SGI study due to study termination.|||Participants|||Count of Participants
2578831|NCT02422940|Secondary|Change From Baseline on the Stroke Impact Scale (SIS)|The SIS consists of 59 items grouped in 8 domains: strength, hand function, activities of daily living (ADL) / instrumental activities of daily living (IADL), mobility, communication, emotion, memory and thinking, and participation/role function. The subject is asked to rate the level of difficulty in performing each item in the preceding week. Each item is scored on a 5-point scale ranging from 1 (inability to complete the item) to 5 (no difficulty experienced at all). For each domain, the SIS score will be calculated by summing all the items within the domain and transforming into a scale with a range of 0 to 100 as follows: SIS Score = 100 * [(Actual raw score - Lowest possible raw score)/ (Highest possible raw score-Lowest possible raw score)].|Day 1, up to 12 months|The study was conducted in patients with chronic walking deficits from an ischemic stroke.|||score on a scale||Standard Deviation|Mean
2578963|NCT02421510|Secondary|Percentage of Participants With A1C <7.0% at Week 24 and no Episode of Severe Hypoglycemia, and no Episode of Diabetic Ketoacidosis (DKA) From Baseline to Week 24|The composite endpoint included blood samples for the assessment of Hemoglobin A1C to determine the participants with a value <7.0% and a central blinded adjudication process to determine whether participants experienced either DKA or severe hypoglycemia. Only positively adjudicated severe hypoglycemia and diabetic ketoacidosis were included in the analysis.|Baseline to Week 24|Analysis included participants from the mITT population.|||Percentage of participants|||Number
2578832|NCT02422940|Secondary|Change From Baseline on the Walking Impact Scale (Walk-12)|The Walk-12 is a 12-question questionnaire that asks subjects to rate limitations of their mobility during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). For each visit, the Walk-12 score will be calculated by summing the 12 components and transforming into a scale with a range of 0 to 100. A higher score indicates a greater degree of limitation in walking. A negative change indicates an improvement in walking. 0 = no limitation in mobility to 100 extreme limitation in mobility. Walk-12 Score = 100 * [(Mean of the 12 items) - 1]/(5-1)|Day 1, up to 12 months|The study was conducted in patients with chronic walking deficits from an ischemic stroke.|||units on a scale||Standard Deviation|Mean
2578833|NCT02422940|Secondary|Change From Baseline on the Timed up and Go (TUG) Test|The TUG measures mobility and balance and can predict the risk of falls. This test, which was initially called the Get-up and Go test, is considered a measure of dynamic balance. The subject is asked to stand up from a chair, walk 10 feet at a comfortable pace, turn around and be seated. The Timed Up and Go (TUG) is measured in seconds. There will be one practice test and then the timed test. Only the timed test will be analyzed at each visit time point. Reciprocal transformation may be performed if the time values are markedly skewed.|Day 1, up to 12 months|The study was conducted in patients with chronic walking deficits from an ischemic stroke.|||Seconds||Standard Deviation|Mean
2578834|NCT02422940|Secondary|Change From Baseline on the 10 Meter Walk Test (10MWT)|10 Meter Walk Test (10MWT) and Change from Baseline by Visit|Day 1, up to 12 months|The study was conducted in patients with chronic walking deficits from an ischemic stroke.|||Meter /second||Standard Deviation|Mean
2578835|NCT02422940|Secondary|Change From Baseline on the Two-Minute Walk Test (2MinWT)|2 Minute Walk Test (2MinWT) and Change from Baseline by Visit|Day 1, up to 12 months|The study was conducted in patients with chronic walking deficits from an ischemic stroke.|||Feet||Standard Deviation|Mean
2578836|NCT02422940|Primary|The Primary Objective Was to Evaluate Serious and Non-serious Adverse Events for Study Participants as a Measure of Safety and Tolerability of Dalfampridine ER (Extended Release) for at Least 12-months.|This extension study was designed to evaluate long-term safety, tolerability, and efficacy of dalfampridine-ER (extended release) in adult subjects with chronic post-ischemic stroke walking deficits. Subjects who had completed the placebo-controlled DALF-PS-1016 core study were eligible to enroll regardless of whether they had received active drug or placebo in the core study.|up to 12 months|"The Safety Population of 293 subjects included all subjects who received at least one dose of study treatment.~*One subject was randomized but discontinued the study prior to receiving double-blind study treatment"|||Participants|||Count of Participants
2578837|NCT02422797|Other Pre-specified|Change From LS Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-CAR Late Switch Group Through Late Switch Phase|Blood samples were collected for CD4+ cell count assessment by flow cytometry. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value.|LS Baseline (Week 48), Weeks 100 and 148|LS ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||Cells/mm^3||Standard Deviation|Mean
2578838|NCT02422797|Other Pre-specified|Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-CAR Late Switch Group Through Late Switch Phase|Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV 1 RNA < 50 c/mL using the FDA snapshot algorithm was assessed. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest.|Weeks 100 and 148|LS ITT-E Population|||Percentage of participants|||Number
2578839|NCT02422797|Other Pre-specified|Change From Baseline in CD4+ Lymphocyte Count at Weeks 100 and 148-DTG+RPV Early Switch Group Through Early and Late Switch Phase|Blood samples were collected for CD4+ cell count assessment by flow cytometry. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1), Weeks 100 and 148|ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|||Cells/mm^3||Standard Deviation|Mean
2578840|NCT02422797|Other Pre-specified|Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Weeks 100 and 148 Using the Snapshot Algorithm-DTG+RPV Early Switch Group Through Early and Late Switch Phase|Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV 1 RNA < 50 c/mL using the FDA snapshot algorithm was assessed. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest.|Weeks 100 and 148|ITT-E Population|||Percentage of participants|||Number
2578841|NCT02422797|Secondary|Change From LS Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-CAR Late Switch Group Through Late Switch Phase|The HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Change from LS Baseline is calculated as the value at specified time point minus LS Baseline value. Total score, lifestyle/ease score and General satisfaction/CS have been summarized. LOCF was used as primary method of analysis.|LS Baseline (Week 48), Weeks 56, 76, 100 and 148|LS ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Score on a scale||Full Range|Median
2578848|NCT02422797|Secondary|Number of Participants With Observed Phenotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class|For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were to be analyzed in an attempt to obtain phenotype data on as many samples as possible. Samples for drug resistance testing (phenotypic) were to be collected at Day 1. Number of participants with phenotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. This outcome was not analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.|Week 48|CVW resistance Population||||||
2578842|NCT02422797|Secondary|Change From Baseline Treatment Satisfaction Using the HIV TSQ at Weeks 56, 76, 100 and 148-DTG+RPV Early Switch Group Through Early and Late Switch Phase|The HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 (very dissatisfied, inconvenient) to 6 (very satisfied, convenient). The items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscale scores: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). Higher scores indicated greater treatment satisfaction as compared to the past few weeks. The HIV TSQ was administered as a paper questionnaire. Change from Baseline is calculated as the value at specified time point minus Baseline value. Total score, lifestyle/ease score and General satisfaction/clinical sub-score (CS) have been summarized. LOCF was used as primary method of analysis.|Baseline (Day 1), Weeks 56, 76, 100 and 148|ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Score on a scale||Full Range|Median
2578843|NCT02422797|Secondary|Change From Baseline Treatment Satisfaction Using the HIV Treatment Satisfaction Questionnaire (HIV TSQ) at Weeks 4, 24 and 48-Early Switch Phase|The HIV TSQ is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience, flexibility. Each item is scored 0 to 6 where a higher score indicates the greater improvement in the past few weeks. These items are summed up to produce a treatment satisfaction total score (0 to 60) and 2 subscales: general satisfaction/clinical and lifestyle/ease subscales (0 to 30). The HIV TSQ was administered as a paper questionnaire. Total score, lifestyle/ease score and General satisfaction/clinical sub-score (CS) have been summarized. LOCF was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1), Weeks 4, 24 and 48|ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Score on a scale||Full Range|Median
2578844|NCT02422797|Secondary|Change From LS Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-CAR Late Switch Group Through Late Switch Phase|The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant. Symptom count is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). LOCF was used as primary method of analysis. Change from LS Baseline was calculated as value at indicated time point minus LS Baseline value.|LS Baseline (Week 48), Weeks 56, 76, 100 and 148|LS ITT-E Population comprised of all participants randomized to CAR who received at least one dose of study treatment at or after the Week 52 Switch visit. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2578845|NCT02422797|Secondary|Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 56, 76, 100 and 148-DTG+RPV Early Switch Group Through Early and Late Switch Phase|The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant. Symptom count is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). LOCF was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1), Weeks 56, 76, 100 and 148|ITT-E Population. Only those participants with data available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2578846|NCT02422797|Secondary|Change From Baseline in Pre-specified Treatment Symptoms Using the Symptom Distress Module at Weeks 4, 24 and 48-Early Switch Phase|The Symptom Distress Module, also called the HIV Symptom Index or Symptoms Impact Questionnaire, is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Symptom count is based on which of the 20 symptoms were present in the participant. Symptom count is the sum of the number of symptoms present and ranges from 0 (none) to 20 (all). Symptom bother score is based on the score for each symptom present ranging from 1 (it doesn't bother me) to 4 (it bothers me a lot). Symptom bother score is the unweighted sum of the bother item scores for each symptom. The symptom bother score ranges from 0 (minimum bother score) to 80 (maximum bother score). Last observation carried forward (LOCF) was used as primary method of analysis. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1), Weeks 4, 24 and 48|ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2578847|NCT02422797|Secondary|Change From Baseline in Fasting Lipids at Weeks 24 and 48 by Baseline Third Agent Treatment Class|Blood samples were collected at Baseline (Day 1), Weeks 24 and 48 to assess fasting lipids which included total cholesterol (CHO), LDL cholesterol, HDL cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1), Weeks 24 and 48|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||mmol/L||Standard Deviation|Mean
2578895|NCT02422303|Primary|Depression Score Using Goldberg Depression Screening Test|"The Goldberg screening test consists of 18 questions which are answered based upon the previous 10-14 days to assess depression:~0-not at all~just a little~somewhat~moderately~quite a lot~very much~The scores are summed, and the ranges are assessed:~0 - 9 No depression likely 10 - 21 Possible symptoms that may be due to depression or other medical issues.~22 - 35 Mild to Moderate Depression. 36 - 53 Moderate to Severe Depression 54 and up Severely Depressed The higher the score, the more severe you depression is likely to be."|One week|Participant data were destroyed at study termination, and no analysis was performed, since no longer available.||||||
2578849|NCT02422797|Secondary|Number of Participants With Observed Genotypic Resistance for Participants Meeting Virologic Withdrawal Criteria by Baseline Third Agent Treatment Class|For all participants who meet virologic withdrawal criteria, plasma samples with HIV-1 RNA level >=200 c/mL were to be analyzed in an attempt to obtain genotype data on as many samples as possible. Samples for drug resistance testing (genotypic) were to be collected at Day 1. Number of participants with genotypic resistance to CAR and to DTG or RPV for those meeting virologic withdrawal criteria in subgroups stratified based on Baseline third agent treatment class (INSTI, NNRTI, PI) were to be summarized. This outcome has not been analyzed as the number of participants was low (1 CVW per arm) and summaries by Baseline third agent were not provided. Therefore, data are not available for this outcome measure due to the insufficient number of participants with events.|Week 48|CVW resistance Population||||||
2578850|NCT02422797|Secondary|Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class|Blood samples were collected at Baseline (Day 1) and at Weeks 4, 8, 12, 24, 36 and 48 to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, MCV, RBC count, WBC count and platelet count. Number of participants who experienced maximum toxicity grade post-baseline in hematology parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) was summarized. Hematology toxicities were graded using the DAIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.|Up to 48 weeks|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2578851|NCT02422797|Secondary|Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks by Baseline Third Agent Treatment Class|Blood samples were collected at Baseline (Day 1) and at Weeks 4, 8, 12, 24, 36 and 48 to evaluate ALT, albumin, ALP, AST, total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, BUN, total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Number of participants who experienced maximum toxicity grade post-baseline in chemistry parameters over 48 weeks by Baseline third agent treatment class (INSTI, NNRTI, PI) is summarized. Clinical chemistry toxicities were graded using the DAIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.|Up to 48 weeks|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2578852|NCT02422797|Secondary|Number of Participants With Any AE, AELD or AE With Grade 1, 2, 3 or 4 Toxicity Over 48 Weeks by Baseline Third Agent Treatment Class|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any AE, AELD or AE with maximum grade toxicity experienced by any one participant over 48 weeks by Baseline third agent class (INSTI, NNRTI, or PI) is summarized. AEs were graded using the Division of AIDS grading. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.|Up to 48 weeks|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2578853|NCT02422797|Secondary|Changes From Baseline in CD4+ Lymphocyte Count at Week 48 by Baseline Third Agent Treatment Class|Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out at Baseline (Day 1) and Week 48 to assess the impact of Baseline third agent class (INSTI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Cells per mm^3||Standard Deviation|Mean
2578854|NCT02422797|Secondary|Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm by Baseline Third Agent Treatment Class|Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 48 using the FDA snapshot algorithm was assessed by Baseline third agent class to assess the impact of Baseline third agent class (INSTI, NNRTI, or PI) on efficacy, safety and tolerability of DTG +RPV compared to continuation of CAR. Plasma samples were collected for HIV-1 RNA at Baseline (Day 1), Week 4, 8, 12, 24, 36 and 48. The analysis was done using Cochran-Mantel Haenszel test stratified by current antiretroviral third-agent class.|Up to Week 48|ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Percentage of participants|||Number
2578855|NCT02422797|Secondary|Pre-dose Concentrations of DTG and RPV at Weeks 2, 4 and 8 in the First 20 Participants Who Switch From Efavirenz (EFV) or Nevirapine (NVP) to DTG + RPV|Two blood samples were collected pre-dose for DTG and RPV at Weeks 2 and 8 only for the first 20 participants who switch from EFV or NVP to DTG+RPV, in addition to the pre-dose blood sample collected at Week 4 for all participants. One blood sample was collected pre-dose for EFV or NVP at Week 2 for the first 20 participants who switch from EFV or NVP to DTG + RPV. PK Parameter NNRTI Subset Extra Sampling Population consisted of the first approximately 20 participants in the PK Parameter NNRTI Subset population who have extra PK samples at weeks 2 and 8.|Pre-dose at Weeks 2, 4 and 8|PK Parameter NNRTI Subset extra sampling Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||ug/ L||Standard Deviation|Mean
2578856|NCT02422797|Secondary|Pre-dose Concentrations of DTG and RPV at Weeks 56, 76 and 100 in Participants Switching to DTG + RPV - CAR Late Switch Group Through Late Switch Phase|Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 56, 76 and 100. Pre-dose concentrations of DTG and RPV at Weeks 56, 76 and 100 is summarized for the participants switching to DTG + RPV in the late switch phase. LS PK Parameter Population comprised of all participants who were randomized to CAR and received DTG + RPV in the Late Switch Phase and provided at least one evaluable estimate of C0.|Pre-dose at Weeks 56, 76 and 100|LS PK Parameter Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||ug/ L||Standard Deviation|Mean
2579122|NCT02420041|Primary|Change in Pain Score From Baseline to 30 Minutes Pre-procedure Using the Defense and Veterans Pain Rating Scale (DoD/VA PRS) 0-10|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.|30 minutes pre-procedure minus baseline||||units on a scale||Full Range|Mean
2578857|NCT02422797|Secondary|Pre-dose Concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 in Participants Switching to DTG + RPV - DTG+RPV Early Switch Group Through Early and Late Switch Phase|Two separate blood samples for DTG and RPV were collected pre-dose at Weeks 4, 24, 48, 56, 76 and 100. Pre-dose concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76 and 100 is summarized for the participants switching to DTG + RPV in the early+late switch phase. Pharmacokinetic (PK) Parameter Population consisted of all participants who received DTG +RPV and provided at least one evaluable estimate of predose concentration (C0).|Pre-dose at Week 4, 24, 48, 56, 76 and 100|PK Parameter Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||ug/ L||Standard Deviation|Mean
2578858|NCT02422797|Secondary|Number of Participants With Phenotypic Resistance-CAR Late Switch Group Through Late Switch Phase|Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW criteria has been presented.|Post-LS Baseline (Week 52) up to Week 148|LS CVW resistance Population|||Participants|||Count of Participants
2578859|NCT02422797|Secondary|Number of Participants With Phenotypic Resistance-DTG+RPV Early Switch Group Through Early and Late Switch Phase|Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW criteria has been presented.|Up to Week 148|CVW resistance Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2578860|NCT02422797|Secondary|Number of Participants With Phenotypic Resistance-Early Switch Phase|Plasma samples were collected for drug resistance testing. Phenotypic Resistance data for the following drugs (DTG, RAL, EVG, RPV, ETR, 3TC, ABC, FTC, TDF, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, SQV/r, TPV/r) in participants Meeting CVW criteria has been presented.|Up to Week 48|CVW resistance Population|||Participants|||Count of Participants
2578861|NCT02422797|Secondary|Number of Participants With Genotypic Resistance-CAR Late Switch Arm Through Late Switch Phase|Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV/r, DRV/r, FPV/r, IDV/r, LPV/r, NFV, RTV, SQV/r, TPV/r) in participants Meeting CVW Criteria has been presented. Late Switch (LS) CVW resistance Population comprised of all participants in the LS ITT-E Population who met CVW through the end of visit window (Week 48, Week 100 or Week 148) and had available on-treatment genotypic resistance data at the time CVW criterion is met.|Post-LS Baseline (Week 52) up to Week 148|LS CVW resistance Population|||Participants|||Count of Participants
2578862|NCT02422797|Secondary|Number of Participants With Genotypic Resistance-DTG+RPV Early Switch Arm Through Early and Late Switch Phase|Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (DTG, Elvitegravir [EVG], Raltegravir [RAL], Delavirdine [DLV], Efavirenz [EFV], Etravirine [ETR], Nevirapine [NVP], RPV, Lamivudine [3TC], Abacavir [ABC], FTC, TDF, Zidovudine [ZDV], Stavudine [d4T], Didanosine [ddI], Atazanavir/r [ATV/r], DRV/r, Fosamprenavir/r [FPV/r], Indinavir/r [IDV/r], Lopinavir/r [LPV/r], Nelfinavir [NFV], Ritonavir [RTV], Saquinavir/r [SQV/r], Tipranavir/r [TPV/r]) in participants Meeting Confirmed Virologic Withdrawal Criteria has been presented.|Up to Week 148|CVW resistance Population|||Participants|||Count of Participants
2578863|NCT02422797|Secondary|Number of Participants With Genotypic Resistance-Early Switch Phase|Plasma samples were collected for drug resistance testing. Genotypic Resistance data for the following drugs (Rilpivirine [RPV], Dolutegravir [DTG]) in participants Meeting Confirmed Virologic Withdrawal (CVW) criteria has been presented. CVW resistance Population comprised of all participants in the ITT-E Population who met CVW through the end of visit window (Week 48, Week 100 or Week 148) and have available on-treatment genotypic resistance data at the time CVW criterion is met.|Up to Week 48|CVW resistance Population|||Participants|||Count of Participants
2578864|NCT02422797|Secondary|Mean Change From Baseline in Fasting Lipids at Weeks 24 and 48|Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol and triglycerides. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1), Weeks 24 and 48|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Millimoles (mmol)/L||Standard Deviation|Mean
2578865|NCT02422797|Secondary|Mean Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess insulin resistance. Change from Baseline was calculated as value at indicated time point minus Baseline value. The homeostatic model assessment (HOMA) of insulin resistance (HOMA-IR ) index , the product of basal glucose and insulin levels divided by 22.5, is regarded as a simple, inexpensive, and reliable surrogate measure of insulin resistance.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed.|||HOMA-IR Score||Standard Deviation|Mean
2578866|NCT02422797|Secondary|Mean Change From Baseline in Interleukin 6 (IL-6) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess IL-6. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Nanograms (ng)/L||Standard Deviation|Mean
2578878|NCT02422797|Secondary|Number of Participants With Maximum Post-baseline Emergent Chemistry Toxicities Over 48 Weeks|Blood samples were collected to evaluate alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, chloride, creatinine, glucose, potassium, phosphate, sodium, blood urea nitrogen (BUN), total carbon dioxide, lipase, creatine phosphokinase and creatinine clearance. Value obtained at Day 1 was considered as Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in clinical chemistry over 48 weeks was summarized. Clinical chemistry toxicities were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a chemistry toxicity.|Up to 48 weeks|Safety Population|||Participants|||Count of Participants
2578867|NCT02422797|Secondary|Mean Change From Baseline in Bone-specific Alkaline Phosphatase, Procollagen 1 N-terminal Propeptide, Osteocalcin, Type 1 Collagen C-telopeptides and Soluble Vascular Cell Adhesion Molecule (sVCAM) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess bone-specific alkaline phosphatase, procollagen 1 N-terminal propeptide, osteocalcin, Type 1 Collagen C-telopeptides and sVCAM. Change from Baseline was calculated as value at indicated time point minus Baseline value. For bone-specific alkaline phosphatase, procollagen 1-N-propeptide, osteocalcin and type 1 collagen C-telopeptide, analyses of changes from Baseline were performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Microgram (ug)/L||Standard Deviation|Mean
2578868|NCT02422797|Secondary|Mean Change From Baseline in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio at Week 48|Urine biomarker samples were collected at Baseline (Day 1) and Week 48 to assess urine albumin/creatinine ratio and urine protein/creatinine ratio. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Grams (g)/mol||Standard Deviation|Mean
2578869|NCT02422797|Secondary|Mean Change From Baseline in Beta-2-microglobulin (B2M) (Blood and Urine), Urine RBP and 25 Hydroxy-vitamin D (Blood) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess B2M and 25 hydroxy-vitamin D. Urine biomarker samples were collected to assess B2M and RBP. Change from Baseline was calculated as value at indicated time point minus Baseline value. For 25 hydroxy-vitamin D, analysis of changes from Baseline was performed on log-transformed data. Results were transformed back via exponential transformation such that treatment comparisons are assessed via odds ratios.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Nanomoles (nmol)/L||Standard Deviation|Mean
2578870|NCT02422797|Secondary|Mean Change From Baseline in Urine Phosphate at Week 48|Urine biomarker samples were collected to at Baseline (Day 1) and Week 48 to assess urine phosphate. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Millimoles (mmol)/L||Standard Deviation|Mean
2578871|NCT02422797|Secondary|Mean Change From Baseline in Retinol Binding Protein (RBP), Serum Creatinine and Glucose at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess RBP, serum creatinine and glucose. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||mg/deciliter (dL)||Standard Deviation|Mean
2578872|NCT02422797|Secondary|Mean Change From Baseline in Soluble CD163 and Oxidized Low Density Lipoprotein (LDL) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess soluble CD163 and oxidized LDL. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Microgram/Liter||Standard Deviation|Mean
2578873|NCT02422797|Secondary|Mean Change From Baseline in Fatty Acid Binding Protein 2 (FABP) and Soluble CD14 at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess FABP and soluble CD14. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Nanogram/milliliter||Standard Deviation|Mean
2578874|NCT02422797|Secondary|Mean Change From Baseline in D-Dimer at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess D-Dimer. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Nanomole/L fibrinogen equivalent units||Standard Deviation|Mean
2578875|NCT02422797|Secondary|Mean Change From Baseline in Cystatin C at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess cystatin C. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed.|||mg/L||Standard Deviation|Mean
2578876|NCT02422797|Secondary|Mean Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 48|Blood biomarker samples were collected at Baseline (Day 1) and Week 48 to assess hs-CRP. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed.|||mg/Liter (L)||Standard Deviation|Mean
2578877|NCT02422797|Secondary|Number of Participants With Maximum Post-baseline Emergent Hematology Toxicities Over 48 Weeks|Blood samples were collected to evaluate hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, mean corpuscular volume (MCV), red blood cell (RBC) count, white blood cell (WBC) count and platelet count. Value obtained at Day 1 was considered as Baseline value. Number of participants who experienced maximum grade toxicity post-baseline in hematology over 48 weeks was summarized. Hematology toxicities were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. For all laboratory parameters, one assessment out of range was sufficient to be considered a hematology toxicity.|Up to 48 weeks|Safety Population|||Participants|||Count of Participants
2578896|NCT02422264|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Day 0, prior to vaccination until the study end, at Month 3 or 5 (depending on vaccination schedule of the country)|The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and for those with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2578879|NCT02422797|Secondary|Number of Participants With Common Non-serious Adverse Event (AE), Any Serious AE (SAE), AE of Maximum Toxicity Grade 1, 2, 3 or 4 and AE Leading to Discontinuation (AELD)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE. AEs were graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading. Grade 1=mild; Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening. Common AEs were those with >5% incidence for either treatment. This summary presents results as reported after all participants completed the Early Switch Phase.|Up to Week 52|Safety Population included all randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2578880|NCT02422797|Secondary|Percentage of Participants With Plasma HIV 1 RNA <50 c/mL at Week 24 Using Snapshot Algorithm|Percentage of participants with plasma HIV 1 RNA <50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity of DTG +RPV once daily compared to continuation of CAR. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA.|Week 24|ITT-E Population|||Percentage of participants|||Number
2578881|NCT02422797|Secondary|Changes From Baseline in Cluster Designation (CD)4+ Lymphocyte Count at Weeks 24 and 48|Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunological activity of DTG + RPV once daily compared to continuation of CAR. Change from Baseline was calculated as value at indicated time point minus Baseline value.|Baseline (Day 1), Weeks 24 and 48|ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Cells per millimeter cube (mm^3)||Standard Deviation|Mean
2578882|NCT02422797|Primary|Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 48 Using Snapshot Algorithm|Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior antiviral activity of switching to DTG+RPV once daily compared to continuation of CAR over 48 weeks in HIV-1 infected antiretroviral therapy (ART)-experienced participants. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA. The Intent-to-Treat Exposed (ITT-E) population consisted of all randomly assigned participants who received at least one dose of study drug.|Week 48|ITT-E Population|||Percentage of participants|||Number
2578883|NCT02422615|Secondary|Duration of Response (DOR)|Time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer as defined in RECIST 1.1|Up to approximately 26 months|||||||
2578884|NCT02422615|Secondary|Time to Response (TTR)|Time from randomization to the first documented and confirmed response (complete response or partial response) as defined by RECIST 1.1|Up to approximately 26 months|||||||
2578885|NCT02422615|Secondary|Clinical Benefit Rate (CBR)|Clinical benefit rate (CBR), defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeks or longer as defined in RECIST 1.1|Up to approximately 26 months|||||||
2578886|NCT02422615|Secondary|Change From Baseline in the Global Health Status/QoL Scale Score of the EORTC QLQ-C30|Change from baseline in the domain scores, health states, overall health status, and index values at the time of each assessment will be summarized.|Up to approximately 26 months|||||||
2578887|NCT02422615|Secondary|Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (QOL) Scale Score of the EORTC QLQ-C30|The time to definitive 10% deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10% relative to baseline worsening of the corresponding scale score (without further improvement above the threshold) or death due to any cause.|Up to approximately 26 months|||||||
2578888|NCT02422615|Secondary|Safety and Tolerability of LEE011|Safety will be determined by type, frequency and severity of adverse events per CTCAE version 4.03 and type, frequency and severity of laboratory toxicities per CTCAE version 4.03.|Up to approximately 26 months|||||||
2578889|NCT02422615|Secondary|Time to Definitive Deterioration of ECOG Performance Status in One Category of the Score|Time to definitive deterioration of ECOG performance status in one category of score is defined as the time from the date of randomization to the date of event, which is defined as at least one score lower than the baseline.|Up to approximately 26 months|||||||
2578890|NCT02422615|Secondary|Overall Response Rate (ORR)|Overall response rate (ORR) is defined as the proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1.|Up to approximately 26 months|||||||
2578891|NCT02422615|Secondary|Progression Free Survival (PFS) Per Blinded Independant Review Committee (BICR)|The primary endpoint of the study is PFS, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS will be assessed via a BICR according to RECIST 1.1|Up to approximately 26 months|||||||
2578892|NCT02422615|Secondary|Overall Survival (OS)|Time from date of randomization to the date of death from any cause.|Up to approximately 58 months|||||||
2578893|NCT02422615|Primary|Progression Free Survival (PFS) Per Investigator Assessment|The primary endpoint of the study is PFS, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS will be assessed via a local radiology assessment according to RECIST 1.1|Up to approximately 26 months|The Full Analysis Set (FAS population) consisted of all randomized patients.|||Months||95% Confidence Interval|Median
2578894|NCT02422446|Primary|Change From Baseline in Endothelial Function at 12 Weeks Using Reactive Hyperemia Index (RHI)|Change in endothelial function between baseline value and 12-week value|Between baseline and 12 weeks||||% change from baseline value||Full Range|Mean
2601683|NCT02150837|Secondary|Waist Circumference|Waist circumference expressed as an absolute change from baseline.|24 weeks||||Inches||Standard Deviation|Mean
2578897|NCT02422264|Secondary|Number of Subjects With Unsolicited Adverse Events|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (days 0-30) follow-up period after each vaccination|The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and for those with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2578898|NCT02422264|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and fever [defined as axillary route temperature ≥ 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Solicited general symptoms were assessed by each and across dose.|During the 4-day (Day 0-Day 3) follow-up period after each vaccination|The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and for those with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2578899|NCT02422264|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Solicited local symptoms were assessed by each and across dose.|During the 4-day (Day 0-Day 3) follow-up period after each vaccination|The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and for those with at least 1 vaccine administration documented.|||Participants|||Count of Participants
2578900|NCT02422264|Secondary|Number of Subjects With Anti-PT, Anti-FHA, Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off.|A seropositive subject is a subject whose antibody concentration is ≥ the assay cut-off defined. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA,2.187 IU/mL for anti-PRN|1 month after the last dose of the primary vaccination|The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.|||Participants|||Count of Participants
2578901|NCT02422264|Secondary|Anti-pneumococcal Antibody Concentrations|Assessed anti-pneumococcal serotypes were (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F), expressed as GMCs and measured in µg/mL.|1 month after the last dose of the primary vaccination|The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.|||µg/mL||95% Confidence Interval|Geometric Mean
2578902|NCT02422264|Secondary|Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations|Anti-PT, anti-FHA, anti-PRN antibody concentrations were expressed as GMCs and measured in IU/mL.|1 month after the last dose of the primary vaccination|The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.|||IU/mL||95% Confidence Interval|Geometric Mean
2578903|NCT02422264|Secondary|Anti-PRP Antibody Concentrations|Anti-PRP antibody concentrations were expressed as GMCs and measured in µg/mL.|1 month after the last dose of the primary vaccination|The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.|||µg/mL||95% Confidence Interval|Geometric Mean
2578904|NCT02422264|Secondary|Anti-HBs Antibody Concentrations|Anti-HBs antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in mIU/mL.|1 month after the last dose of the primary vaccination|The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.|||mIU/ml||95% Confidence Interval|Geometric Mean
2578905|NCT02422264|Secondary|Anti-Polio Type 1, 2 and 3 Antibody Titers|Anti-Polio type 1, 2 and 3 antibody titers were expressed as geometric mean titers (GMT).|1 month after the last dose of the primary vaccination|The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.|||Titers||95% Confidence Interval|Geometric Mean
2578906|NCT02422264|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in IU/mL.|1 month after the last dose of the primary vaccination|The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.|||IU/ml||95% Confidence Interval|Geometric Mean
2578907|NCT02422264|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Anti-PT, anti-FHA and anti-PRN antibody concentrations were expressed as GMCs and measured in IU/mL.|Before the first dose of Infanrix hexa|The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.|||IU/ml||95% Confidence Interval|Geometric Mean
2579123|NCT02420041|Primary|Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy|during procedure from the time monitors are placed on patient to the time of withdrawal of needle from skin|difference in minutes between a sacroiliac joint injection, an expected average of 9 minutes||||minutes||Full Range|Mean
2601684|NCT02150837|Secondary|Waist Circumference|Waist circumference expressed as an absolute change from baseline.|20 weeks||||Inches||Standard Deviation|Mean
2578908|NCT02422264|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off.|A seropositive subject is a subject whose antibody concentration is ≥ the assay cut-off defined. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA,2.187 IU/mL for anti-PRN|Before the first dose of Infanrix hexa|The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.|||Participants|||Count of Participants
2578909|NCT02422264|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in IU/mL.|Before the first dose of Infanrix hexa|The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.|||IU/mL||95% Confidence Interval|Geometric Mean
2578910|NCT02422264|Secondary|Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off.|A seroprotected subject is a subject whose antibody concentration was ≥ the level defining clinical protection, of 0.1 IU/mL.|Before the first dose of Infanrix hexa|The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.|||Participants|||Count of Participants
2578911|NCT02422264|Primary|Number of Seroprotected Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Above or Equal to the Assay Cut-off|A seroprotected subject is a subject whose antibody concentration/titre was ≥ the level defining clinical protection, of 0.15 micrograms per milliliter (µg/mL).|1 month after the last dose of the primary vaccination|The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.|||Participants|||Count of Participants
2578912|NCT02422264|Primary|Number of Seroprotected Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentration Above or Equal to 8|A seroprotected subject is a subject whose antibody titre was ≥ the level defining clinical protection, of 8 ED50.|1 month after the last dose of the primary vaccination|The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.|||Participants|||Count of Participants
2578913|NCT02422264|Primary|Number of Seroprotected Subjects With Anti Hepatitis B (Anti-HBs) Antibody Concentration Above or Equal to the Assay Cut-off|A seroprotected subject is a subject whose antibody concentration/titre was ≥ to the level defining clinical protection, of 10 micro International Units per milliliter (mIU/mL).|1 month after the last dose of the primary vaccination|The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.|||Participants|||Count of Participants
2578914|NCT02422264|Primary|Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off|A seroprotected subject is a subject whose antibody concentration/titre was ≥ the level defining clinical protection, of 0.1 International Units per milliliter (IU/mL).|1 month after the last dose of the primary vaccination|The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the TVC who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component.|||Participants|||Count of Participants
2578915|NCT02422264|Primary|Number of Subjects With Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens|Vaccine response to the PT, FHA and PRN antigens, is defined as the appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations lower than (<) the cut-off value of the assay), or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations greater than or equal to (≥) the cut-off value of the assay). Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, 2.187 IU/mL for anti-PRN.|1 month after the last dose of the primary vaccination|The analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects from the Totally vaccinated cohort (TVC) who complied with the vaccine administration and with the protocol and for whom data concerning immunogenicity outcome measures were available for at least one study vaccines antigen component|||Participants|||Count of Participants
2578916|NCT02422186|Secondary|Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) to Endpoint (Double-blind Induction Phase [Day 28]): Sum Score|"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 (health state value equal to dead) and 0.949 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state."|Baseline and Endpoint (Double-blind Induction Phase [Day 28])|The full analysis set was defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind induction phase. Here, N (Overall number of participants analyzed) signifies number of participants who were evaluable for this endpoint.|||Units on a scale||Standard Deviation|Mean
2578917|NCT02422186|Secondary|Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) to Endpoint (Double-blind Induction Phase [Day 28]): EQ-VAS|EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine).|Baseline and Endpoint (Double-blind Induction Phase [Day 28])|The full analysis set was defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind induction phase. Here, N (Overall number of participants analyzed) signifies number of participants who were evaluable for this endpoint.|||Units on a scale||Standard Deviation|Mean
2578918|NCT02422186|Secondary|Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) to Endpoint (Double-blind Induction Phase [Day 28]): Health Status Index|"EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a health status index (HSI). HSI ranges from -0.148 (health state value equal to dead) and 0.949 (full health), is anchored at 0 (dead) and 1 (full health)."|Baseline and Endpoint (Double-blind Induction Phase [Day 28])|The full analysis set was defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind induction phase. Here, N (Overall number of participants analyzed) signifies number of participants who were evaluable for this endpoint.|||Units on a scale||Standard Deviation|Mean
2578919|NCT02422186|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis on Ranks|"CGI-S provides an overall clinician-determined summary measure of the severity of the participants illness including participants history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participants ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Missing data was imputed using LOCF method and last post baseline observation during the double-blind induction phase was carried forward as the End Point for that phase."|Baseline and Endpoint (Double-blind Induction Phase [Day 28])|The full analysis set was defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind induction phase. Here, N (Overall number of participants analyzed) signifies number of participants who were evaluable for this endpoint.|||Units on a scale||Full Range|Median
2578920|NCT02422186|Secondary|Percentage of Participants in Remission (MADRS<=12) at Endpoint (Double-blind Induction Phase [Day 28]) (LOCF Data)|"Remission was defined as participants who had a MADRS total score of less than or equal to (=<) 12. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Missing data was imputed using LOCF method and last post baseline observation during the double-blind induction phase was carried forward as the End Point for that phase."|At Endpoint-Double-blind Induction Phase [Day 28]|The full analysis set was defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind induction phase. Here, N (Overall number of participants analyzed) signifies number of participants who were evaluable for this endpoint.|||Percentage of Participants|||Number
2578921|NCT02422186|Secondary|Percentage of Participants Who Achieved >=50% Reduction From Baseline in MADRS Total Score at Endpoint (Double-blind Induction Phase [Day 28]) (LOCF Data)|"Percentage of participants with greater than or equal to (>=50) percent (%) reduction from baseline are reported. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Missing data was imputed using LOCF method and last post baseline observation during the double-blind induction phase was carried forward as the End Point for that phase."|At Endpoint-Double-blind Induction Phase [Day 28]|The full analysis set was defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind induction phase. Here, N (Overall number of participants analyzed) signifies number of participants who were evaluable for this endpoint.|||Percentage of Participants|||Number
2578936|NCT02421939|Secondary|Duration of Event-Free Survival (EFS)|"EFS was defined as the time from the date of randomization until the date of documented relapse (excluding relapse after PR), treatment failure or death from any cause within 30 days after the last dose of study drug, whichever occurred first (earliest of [relapse date, treatment failure date, death date] - randomization date + 1). If a participant experienced relapse or death within 30 days after the last dose of study drug, the participant was defined as having an EFS event related to either relapse or death, and the event date was the date of relapse or death. For a participant who was not known to have had a relapse or treatment failure or death event, EFS was censored at the date of last relapse-free disease assessment (last relapse-free disease assessment date - randomization date + 1). Data was estimated based on Kaplan-Meier estimates."|From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months|The analysis population was the ITT.|||Months||95% Confidence Interval|Median
2582083|NCT02384200|Secondary|Participants With Positive Kidney Stone Culture|Kidney stone sent for culture|once, within 6 hours of start of surgery||||Participants|||Count of Participants
2578922|NCT02422186|Primary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score to Endpoint (Double-blind Induction Phase [Day 28])- Analysis of Covariance (ANCOVA) Analysis|"The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items (to evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel [interest level], pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0-60. Higher scores represent a more severe condition. Negative change in score indicates improvement. Missing data was imputed using Last Observation Carried Forward (LOCF) method and last post baseline observation during the double-blind induction phase was carried forward as the End Point for that phase."|Baseline and Endpoint (Double-blind Induction Phase [Day 28])|The full analysis set was defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind induction phase. Here, N (Overall number of participants analyzed) signifies number of participants who were evaluable for this endpoint.|||Units on a scale||Standard Deviation|Mean
2578923|NCT02422186|Primary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- Mixed-Effects Model Using Repeated Measures (MMRM) Analysis|The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items (to evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel [interest level], pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0-60. Higher scores represent a more severe condition. Negative change in score indicates improvement.|Baseline up to Endpoint (Double-blind Induction Phase[Day 28])|The full analysis set (FAS) was defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during the double-blind induction phase. Here, N (Overall number of participants analyzed) signifies number of participants who were evaluable for this endpoint.|||Units on a scale||Standard Deviation|Mean
2578924|NCT02421952|Secondary|Age-Related Ability to Use the BARF Scale|The age-related ability to use the BARF scale was determined by constructing receiver operating characteristic (ROC) curves and calculating the area under the ROC curve and the 95% confidence interval (CI), along with sensitivity and specificity.|Comprehensive|All enrolled subjects were included.|||percentage||95% Confidence Interval|Number
2578925|NCT02421952|Secondary|Incidence of Post-Discharge Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in Subjects Who Returned the Diary|"Patients were discharged from the PACU when they achieved institutional discharge criteria. The parents were given a diary to record the maximum nausea on the VAS and BARF scales during the first 24 postoperative hours. Each child's caretaker was contacted by phone 24 hours after surgery to determine whether the child had any nausea or vomiting and which medications were given after discharge. The VAS uses a horizontal 10cm line with the extremes of no pain at all and worst pain imaginable. The subject marks on the line their pain rating. Higher points indicate more severe or intense pain. FACES scale has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more pain). The BARF scales has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more nausea)."|First 24 postoperative hours||||Participants|||Count of Participants
2578926|NCT02421952|Primary|Number of Patients With Nausea, Emesis, Severe Nausea, Severe Emesis and Number Receiving Rescue Antiemetics in the Post-Anesthetic Care Unit (PACU)|"To measure pain and nausea, subjects completed the VAS and two pictorial scales (Faces Pain Scale-Revised for pain and BARF for nausea). The VAS uses a horizontal 10cm line with the extremes of no pain at all and worst pain imaginable. The subject marks on the line their pain rating. Higher points indicate more severe or intense pain. FACES scale has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more pain). The BARF scales has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more nausea)."|When awake and responding to commands in the post-anesthesia care unit (PACU)|Patients with severe nausea were included in the number with any nausea. Patients with severe emesis were included in the number with any emesis. Because some patients had both nausea and vomiting, the sum of the number with nausea and the number with emesis will not equal those with either nausea or emesis.|||Participants|||Count of Participants
2578927|NCT02421939|Secondary|Number of Participants With Adverse Events|"A treatment-emergent adverse event (TEAE) was defined as an AE observed after starting administration of the study drug (gilteritinib or salvage chemotherapy). If the AE occurred on day 1 and the onset check box was marked Onset after first dose of study drug or the onset check box was left blank, then the AE was considered treatment emergent. If the AE occurred on day 1 and the onset check box was marked Onset before first dose of study drug, then the AE was not considered treatment emergent. Majority of salvage chemotherapy participants finished the study by cycle 2 of treatment, the duration of exposure was longer in the gilteritinib arm compared with the salvage chemotherapy arm (126.00 [4.0, 885.0] days versus 28.0 [5.0, 217.0] days). The NCI-CTCAE is defined as National Cancer Institute-Common Terminology Criteria for Adverse Events."|From first dose of study drug up to 30 days after the last dose of study drug (median treatment duration for gilteritinib was (126.00 [4.0, 885.0]) days versus salvage chemotherapy 28.0 [5.0, 217.0] days)|The analysis population was the safety analysis set (SAF), which consisted of participants who received who received at least 1 dose of study drug (gilteritinib or salvage chemotherapy).|||Participants|||Count of Participants
2578937|NCT02421939|Primary|Percentage of Participants With Complete Remission and Complete Remission With Partial Hematological Recovery (CR/CRh) in the Gilteritinib Arm|The CR/CRh rate was defined as the number of participants who achieved either CR or CRh at any of the postbaseline visits divided by the number of participants in the analysis population.|From randomization until the data cut-off date 04 Aug 2017, the 142 patients included in the primary analysis of CR/CRh rate were followed up at least 112 days|The analysis population was the response analysis set (RAS) which consisted of participants who were who were at least 112 days past the first dose of gilteritinib or randomization (for participants who did not receive gilteritinib). The participants were analyzed based on the randomized treatments.|||Percentage of participants||95% Confidence Interval|Number
2578928|NCT02421939|Secondary|Percentage of Participants Who Achieved Transfusion Conversion and Maintenance|Transfusion conversion & maintenance rate was defined for gilteritinib arm. Participants were classified as transfusion independent if there were no RBC or platelet transfusions within 28 days prior to the first dose to 28 days after the first dose; otherwise they were classified as transfusion dependent at baseline. Participants were considered independent postbaseline if they had 1 consecutive 8 week period without any RBC or platelet transfusion from 29 days after the first dose until the last dose date. For participants who were on treatment ≤ 4 weeks or > 4 weeks but < 12 weeks and there was no RBC or platelet transfusion within postbaseline period, they were considered not evaluable; otherwise, they were considered postbaseline transfusion dependent. Transfusion conversion rate was defined for participants who had evaluable postbaseline transfusion status. Transfusion status (independent vs. dependent) at baseline and postbaseline was reported in a 2 by 2 contingency table.|From randomization until the data cut-off date of 17 Sep 2018, median treatment duration for gilteritinib was (126.00 [4.0, 885.0]) days versus salvage chemotherapy 28.0 [5.0, 217.0] days)|The analysis population was the ITT, with participants who had evaluable postbaseline transfusion status.|||Percentage of participants|||Number
2578929|NCT02421939|Secondary|Percentage of Participants With Complete Remission (CR) With Partial Hematological Recovery (CRh)|CRh rate was defined as the number of participants who achieved CRh at any of the postbaseline visits and did not have a best response of CR divided by the number of participants in the analysis population.|From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months|The analysis population was the ITT.|||Percentage of participants||95% Confidence Interval|Number
2578930|NCT02421939|Secondary|Change From Baseline in Brief Fatigue Inventory (BFI)|The Brief Fatigue Inventory (BFI) is a screening tool designed to assess the severity and impact of fatigue on daily functioning of participants with cancer during the 24 hours. There are 9 items on the scale. The first three questions ask participants to rate their fatigues on a scale from 0 (no fatigue) - 10 (as bad as you can imagine), with higher scores indicating worse outcome. The remaining six questions ask participants to rate how much fatigue has interfered with their daily activities on a scale from 0 (Does not interfere) to 10 (Completely interferes). A global fatigue score can be obtained by averaging all the items on the BFI. The global BFI score will be calculated only if at least 5 of the 9 items are answered. A higher BFI fatigue score indicates worse outcome.|Baseline and cycle 1, day 8 and cycle 2 day 1 (up to data cut off date of 17 Sep 2018)|The analysis population was the ITT, with participants with data at baseline.|||Units on a scale||Standard Deviation|Mean
2578931|NCT02421939|Secondary|Percentage of Participants Who Underwent Hematopoietic Stem Cell Transplant|Transplantation rate is defined as the percentage of participants undergoing Hematopoietic stem cell transplant (HSCT) during the study period.|From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months|The analysis population is the ITT.|||Percentage of participants||95% Confidence Interval|Number
2578932|NCT02421939|Secondary|Percentage of Participants With Composite Complete Remission (CRc Rate)|CRc rate was defined as the number of participants who achieved the best response of CRc (CR,complete remission with incomplete platelet recovery (CRp) or complete remission with incomplete hematologic recovery (CRi) divided by the number of participants in the analysis population.|From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months|The analysis population was the ITT.|||Percentage of participants||95% Confidence Interval|Number
2578933|NCT02421939|Secondary|Duration of Remission|Duration of remission included duration of composite complete remission (CRc), duration of complete remission (CR)/ complete remission with partial hematologic recovery (CRh), duration of CRh, duration of CR and duration of response (CRc + partial remission (PR). The duration of response was defined as the time from the date of either first CRc or PR until the date of documented relapse (i.e., the date of first NR after CRc or PR) for participants who achieved CRc or PR (relapse date - first CRc or PR disease assessment date + 1). Participants who died without report of relapse were considered nonevents and censored at their last relapse-free disease assessment date (last relapse-free disease assessment date - first CRc or PR disease assessment date + 1). Other participants who did not relapse during the study were considered nonevents and censored at the last relapse-free assessment date. Duration of CR was only applicable to participants with best overall response of CR.|From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months|The analysis population was the ITT, Duration of CR was only applicable to participants with best overall response of CR.|||Months||95% Confidence Interval|Median
2578934|NCT02421939|Secondary|Duration of Leukemia-Free Survival (LFS)|The LFS was defined as the time from the date of first CRc until the date of documented relapse (excluding relapse from PR) or death for participants who achieved CRc (relapse date or death date - first CRc disease assessment date + 1). For a participant who was not known to have relapsed or died, LFS was censored on the date of last relapse-free disease assessment date (last relapse-free disease assessment date - first CRc disease assessment date + 1). For a participant who was not known to have relapsed or died, LFS was censored on the date of last relapse-free disease assessment date (last relapse-free disease assessment date - first CRc disease assessment date + 1).|From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months|The analysis population was the ITT, with participants with best response of CRc.|||Months||95% Confidence Interval|Median
2578935|NCT02421939|Secondary|Percentage of Participants With Complete Remission (CR) Rate|The CR rate was defined as the number of participants who achieved the best response of CR divided by the number of participants in the analysis population.|From randomization until the data cut-off date of 17 Sep 2018, all participants included in the primary analysis of CR rate were followed up at least 6 months|The analysis population was the ITT.|||Percentage of participants||95% Confidence Interval|Number
2578961|NCT02421510|Secondary|Change From Baseline in Mean Daily Bolus Insulin Dose at Week 24|The mean bolus insulin dose in international units/day (IU/day) for Week 24 was the average over the 3 to 5 days prior to the Week 24 visit. The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicated a reduction in the amount of bolus insulin used and a positive change from baseline indicated an increase in the amount of bolus insulin used between baseline and Week 24.|Baseline to Week 24|Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||IU/day||Standard Error|Least Squares Mean
2578938|NCT02421939|Primary|Duration of Overall Survival (OS)|Overall survival was defined as the time from the date of randomization until the date of death from any cause (death date - randomization date + 1). For a participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact (date of last contact - randomized date + 1). The date of last contact was the latest date that the participant was known to be alive by the cutoff date. The last contact date was derived for participants alive at the analysis cutoff date. Survival rate and 95% CI were estimated using the Kaplan-Meier method and the Greenwood formula.|From randomization until the data cut-off date of 17 Sep 2018, median time of follow-up for OS was 17.8 months|The analysis population was the Intention to Treatment (ITT) which consisted of all randomized participants.|||Months||95% Confidence Interval|Median
2578939|NCT02421887|Secondary|Change in Total Sperm Count|Samples assessed using a standard semen analysis|baseline and 3 months|Participants for which semen samples were analyzed at both Baseline and Month 3 visit are included in this outcome measure.|||million sperm per sample||Inter-Quartile Range|Median
2578940|NCT02421887|Secondary|Change in Normal Morphology of Semen, Using World Health Organization (WHO) 5 Criteria|Samples assessed using a standard semen analysis|baseline and 3 months|Participants for whom semen samples were analyzed for morphology at both Baseline and Month 3 visit are included in this outcome measure.|||percentage of sperm with normal morpholo||Inter-Quartile Range|Median
2578941|NCT02421887|Secondary|Change in Sperm Concentration|Samples assessed using a standard semen analysis|baseline and 3 months|Participants for which semen samples were analyzed at both Baseline and Month 3 visit are included in this outcome measure.|||million sperm per mL||Inter-Quartile Range|Median
2578942|NCT02421887|Secondary|Change in Semen Total Motility|Samples assessed using a standard semen analysis|baseline and 3 months||||percentage of sperm with any motility||Standard Deviation|Mean
2578943|NCT02421887|Secondary|Change in Deoxyribonucleic Acid (DNA) Fragmentation Index (DFI)|DFI is the ratio of damaged sperm to total sperm. It is measured using Sperm Chromatin Structure Analysis (SCSA) which was performed on 5000 sperm per sample.|Baseline and 3 months|Participants for which semen samples were analyzed for DFI at both Baseline and Month 3 visit are included in this outcome measure.|||percentage of damaged DNA to total DNA||Inter-Quartile Range|Mean
2578944|NCT02421887|Secondary|Change in Total Motile Sperm Count|Samples will be assessed using a standard semen analysis|baseline and 3 months|Participants for which semen samples were analyzed at both Baseline and Month 3 visit are included in this outcome measure.|||million sperm per mL||Inter-Quartile Range|Median
2578945|NCT02421887|Secondary|Time to Pregnancy|Time to pregnancy will be the chronologic time from randomization to pregnancy detection in days, in which the pregnancy is defined as a human Chorionic Gonadotropin (hCG) value over 5 on 2 separate occasions.|up to 7 months|Time to pregnancy is calculated only for subjects who obtained pregnancy during the trial.|||days||Standard Deviation|Mean
2578946|NCT02421887|Secondary|Miscarriage Rate|miscarriages per total number of pregnancies|up to 9 months|Miscarriage rate is calculated per number of participants who became pregnant.|||miscarriages|||Number
2578947|NCT02421887|Secondary|Pregnancy Rate||up to 7 months||||Participants|||Count of Participants
2578948|NCT02421887|Primary|Live Birth Rate||up to 15 months||||percentage of live births|||Number
2578949|NCT02421588|Secondary|Best Response According to Tumor Marker Evaluation (CA-125)|"Best response according to tumor marker evaluation (CA-125): defined as the best response obtained according to GCIG criteria. Tumor marker assessments were performed at baseline and every eight weeks from randomization until evidence of PD. Progression based on serum CA-125 levels was defined on the basis of a progressive serial elevation of serum CA-125 according to:~A. Patients with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 greater than, or equal to, 2 times the upper limit of the reference range on 2 occasions at least 1 week apart or B. Patients with elevated CA-125 before treatment, which never normalizes, must show evidence of CA-125 greater than, or equal to, 2 times the nadir value on 2 occasions at least 1 week apart or C. Patients with CA-125 in the reference range before treatment must show evidence of CA-125 greater than, or equal to, 2 times the upper limit of the reference range on 2 occasions at least 1 week apart."|At baseline and every eight weeks from randomization until evidence of PD, up to 3 years||||Participants|||Count of Participants
2578950|NCT02421588|Secondary|Duration of Response by Investigator's Assessment|"Duration of response (DR): calculated from the date of first documentation of response per RECIST v.1.1 (CR or PR, whichever came first) to the date of documented PD or death. The censoring rules defined above for PFS were used for duration of response.~Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments.~Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR."|The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years|Patients who have CR or PR|||months||95% Confidence Interval|Median
2578951|NCT02421588|Secondary|Duration of Response by Independent Review Committee|"Duration of response (DR): calculated from the date of first documentation of response per RECIST v.1.1 (CR or PR, whichever came first) to the date of documented PD or death. The censoring rules defined above for PFS were used for duration of response.~Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments.~Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR."|The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years|Patients who have CR or PR|||months||95% Confidence Interval|Median
2579243|NCT02418026|Primary|Wellbeing Measured Using a Comfort Scale|"The comfort scale is a numeric rating scale ranging from 0 to 10 : 0 corresponds to no comfort and 10 corresponds to most comfortable."|just after surgery, up to 1 hour||||units on a scale||Standard Deviation|Mean
2578952|NCT02421588|Secondary|Overall Response Rate by Investigator's Assessment|"Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments.~Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum; Overall Response (OR)=CR+PR."|At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years||||Participants|||Count of Participants
2578953|NCT02421588|Secondary|Overall Response Rate (ORR) by Independent Review Committee|"Best antitumor response defined as the best response obtained according to RECIST v.1.1. Tumor assessment were performed at baseline and every 8 weeks from randomization until evidence of PD. Patients who discontinued treatment without PD continued with assessments.~Antitumor activity was assessed using the RECIST v.1.1 by the appropriate method [computed tomography scan or magnetic resonance imaging]: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum; Overall Response (OR)=CR+PR."|At baseline and every eight weeks from randomization until evidence of PD, assessed up to 3 years||||Participants|||Count of Participants
2578954|NCT02421588|Secondary|Overall Survival (OS)|Calculated from the date of randomization to the date of death (death event) or last contact (in this case, survival was censored on that date).|From the date of randomization to the date of death or last contact, up to 12 months after last patient inclusion, for a maximum of up to 3 years||||months||95% Confidence Interval|Median
2578955|NCT02421588|Secondary|Progression-free Survival by Investigator's Assessment|The primary endpoint was PFS by Investigator's Assessment, defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient received further antitumor therapy or was lost to follow-up before PD, PFS was censored at the date of last tumor assessment before the date of subsequent antitumor treatment.|Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years||||months||95% Confidence Interval|Median
2578956|NCT02421588|Primary|Progression-free Survival by Independent Review Committee|The primary endpoint was PFS by IRC assessment, defined as the time from the date of randomization to the date of documented progression per RECIST v.1.1 or death (regardless of the cause of death). If the patient received further antitumor therapy or was lost to follow-up before PD, PFS was censored at the date of last tumor assessment before the date of subsequent antitumor treatment.|Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years||||months||95% Confidence Interval|Median
2578957|NCT02421510|Secondary|Percent Change From Baseline in Body Weight at Week 24|Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative percent change from baseline indicates a loss in body weight from baseline to Week 24.|Baseline to Week 24|Analysis included participants from the mITT population, including all available post baseline values. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||Percent change||Standard Error|Least Squares Mean
2578958|NCT02421510|Secondary|Change From Baseline in 2-Item Diabetes Distress Screen 2 (DDS2) Score at Week 24|DDS2 is a 2-item diabetes distress screening instrument where participants rated the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen using a 6-point scale: where 1=no distress to 6=severe distress for a total possible score of 2 to 12. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicates improvement.|Baseline to Week 24|Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||Score on a scale||Standard Error|Least Squares Mean
2578959|NCT02421510|Secondary|Change From Baseline in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score at Week 24|The DTSQ instrument contains 8 items assessing overall treatment satisfaction, treatment convenience and flexibility, satisfaction with understanding of diabetes, willingness to continue present treatment and to recommend it to others, and frequency of unacceptably high and unacceptably low blood glucose levels. 6 items (1, 4, 5, 6, 7 and 8) (excluding perceived hyperglycemia and hypoglycemia items) were scored using a 7- point scale where 0=very dissatisfied to 6= very satisfied for a total possible score of 0 (very dissatisfied) to 36 (very satisfied), where higher scores indicate higher satisfaction from treatment. Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively. The baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A positive change from baseline indicates improvement.|Baseline to Week 24|Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||Score on a scale||Standard Error|Least Squares Mean
2578960|NCT02421510|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicates a lower glucose level at Week 24 compared to baseline and a positive change from baseline indicates an increase in glucose level at Week 24 compared to baseline.|Baseline to Week 24|Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||Milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
2579328|NCT02417376|Secondary|Change From Baseline WBC Profile at 6 Months|Change from baseline in white blood cell profile assessed at 6 months.|Baseline and 6 months||||per cmm||Standard Deviation|Mean
2578964|NCT02421510|Primary|Change From Baseline in A1C at Week 24|Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least square (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) that included fixed, categorical effects of treatment, randomization strata of insulin delivery method (MDI, CSII), randomization strata of Week -2 A1C (<= 8.5%, >8.5%), time (study week), a treatment-by-time interaction, and baseline A1C-by-time interaction as a covariate. A negative change from baseline (a reduction of A1C value at Week 24) indicates an improvement.|Baseline to Week 24|Analysis included participants from the modified intent to treat (mITT) population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||Percentage of A1C||Standard Error|Least Squares Mean
2578965|NCT02421419|Secondary|Number of Participants With Adverse Effects|Incidence of adverse effects|Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection.|Adverse effects was collected on all study participants except for the one patient who was withdrawn after enrollment (CSS group)|||Participants|||Count of Participants
2578966|NCT02421419|Secondary|Degree of Triggering|A Green classification number (0-4) is given to each subject pre-injection and at 6 weeks post-injection based on their degree of triggering. 0 = No triggering, no pain; 1 = Pre-triggering; pain, history of catching, but not demonstrable on physical examination; tenderness over the A1 pulley; 2 = Active; demonstrable catching, but the patient can actively extend the digit; 3= Passive; demonstrable catching requiring passive extension or inability to actively flex; and 4 = Contracture; demonstrable catching with a fixed flexion contracture of the PIP joint.|Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient Survey|Data collected on all subjects enrolled except for one that was withdrawn after enrollment.|||Participants|||Count of Participants
2578967|NCT02421419|Secondary|Presence of Triggering|Patients are asked how often their finger triggers - not at all, rarely, occasionally, or frequently at time intervals indicated in the outcome measure time frame. Count of participants for each of these answers was collected.|Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injection|All participants from three groups were asked this question. Data was not collected on subject (CSS group) that withdrew from study after enrollment.|||Participants|||Count of Participants
2578968|NCT02421419|Primary|VAS|Visual Analogue Pain Scale (VAS) - measurement of pain on scale of 0 (least) to 10 (worst).|Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, at 6 weeks post-injection and also asked to recollect their pain at time of injection when seen at 6 weeks post-injection|VAS was collected on all study participants except for the one patient (CSS group) who was withdrawn after enrollment and before any measurements were taken.|||units on a scale||Standard Deviation|Mean
2578969|NCT02421354|Primary|Objective Response Rate, Defined as Complete Remission + Partial Remission + Clinical Improvement|Responses will be categorized according to the revised International Working Group-Myeloproliferative Neoplasms Research and Treatment and European LeukmiaNet consensus criteria for myelofibrosis.|14 weeks (after 8 doses of therapy)||||Participants|||Count of Participants
2578970|NCT02421211|Secondary|Number of Participants Not Achieving Sustained Virologic Response (SVR) Showing Emerging Mutation in HCV Nonstructural Protein 3/4A (NS3/4A), Nonstructural Protein 5A (NS5A), and Nonstructural Protein 5B (NS5B) Sequence||Up to end of follow-up phase (Week 12 of follow-up phase) in Panel 1 and Panel 2|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Since the data was to be analysed in the participants who did not achieve SVR, but all the participants achieved SVR in the study. Therefore the data was not collected for this outcome measure.||||||
2578971|NCT02421211|Secondary|Percentage of Participants With Viral Relapse|Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up.|Up to Week 12 follow-up phase after EOT|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.|||percentage of participants|||Number
2578972|NCT02421211|Secondary|Percentage of Participants With On-treatment Failure|On-treatment failure is defined as participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. This was to include participants with: 1) Viral breakthrough, defined as a confirmed increase of greater than (>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA of >100 IU/mL in participants whose HCV RNA had previously been <LLOQ while on treatment; 2) Other with confirmed detectable HCV RNA at the actual end of treatment (example, completed, discontinued due to AEs, withdrawal of consent).|Day 70 in Panel 1 and Day 56 in Panel 2|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.|||percentage of participants|||Number
2578973|NCT02421211|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) 4 Weeks After the Actual EOT (SVR4) and 12 Weeks After the Actual EOT (SVR12)|SVR4 or SVR12 is defined as sustained virologic response 4 or 12 weeks after the actual EOT the participant has HCV RNA <LLOQ detectable or undetectable.|4 weeks after EOT (Week 4 of follow-up phase in Panel 1 and Panel 2) and 12 weeks after EOT (Week 12 of follow-up phase in Panel 1 and Panel 2)|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.|||percentage of participants|||Number
2578974|NCT02421211|Secondary|Percentage of Participants With On-treatment Virologic Response|"On-treatment virologic response was determined by hepatitis C virus (HCV) ribonucleic acid (RNA) results satisfying a specified threshold.~The following thresholds were considered at any time point: less than (<) lower limit of quantification (LLOQ) undetectable, <LLOQ detectable and <LLOQ undetectable/detectable."|Week 1, up to EOT (Week 10 in Panel 1 and Week 8 in Panel 2)|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.|||percentage of participants|||Number
2578975|NCT02421211|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to 10 Weeks for Panel 1 and 8 Weeks for Panel 2|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.|||number of participants|||Number
2578976|NCT02421211|Secondary|Fluctuation Index (FI) of Ledipasvir|Fluctuation index is defined as percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax Cmin]/Cavg).|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||percentage fluctuation||Standard Deviation|Mean
2578977|NCT02421211|Secondary|Average Plasma Concentration at Steady State (Cavg,ss) of Ledipasvir|The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau).|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2578978|NCT02421211|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ledipasvir|The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||Hour||Full Range|Median
2578979|NCT02421211|Secondary|Trough Plasma Concentration (Ctrough) of Ledipasvir|The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.|Pre-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2578980|NCT02421211|Secondary|Fluctuation Index (FI) of Simeprevir|Fluctuation index is defined as percentage fluctuation (variation between maximum and minimum concentration at steady state), calculated as: 100*([Cmax Cmin]/Cavg).|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||percentage fluctuation||Standard Deviation|Mean
2578981|NCT02421211|Secondary|Average Plasma Concentration at Steady State (Cavg,ss) of Simeprevir|The Cavg,ss is calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau).|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2578982|NCT02421211|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir|The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||hour (H)||Full Range|Median
2578983|NCT02421211|Secondary|Trough Plasma Concentration (Ctrough) of Simeprevir|The (Ctrough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen.|Pre-dose on Day 14 and Day 28|The Intent-to-treat (ITT) analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||nanogram per Milliliters (ng/mL)||Standard Deviation|Mean
2578984|NCT02421211|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Ledipasvir|AUCtau is defined as area under the analyte concentration versus time curve during dosing interval tau, calculated by linear-linear trapezoidal summation.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||ng*h/mL||Standard Deviation|Mean
2578985|NCT02421211|Primary|Maximum Plasma Concentration (Cmax) of Ledipasvir|The Cmax is the maximum observed plasma concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2578986|NCT02421211|Primary|Minimum Plasma Concentration (Cmin) of Ledipasvir (LDV)|The Cmin is the minimum observed plasma concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2578987|NCT02421211|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Simeprevir|The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||nanogram hour per Milliliters (ng*h/mL)||Standard Deviation|Mean
2578988|NCT02421211|Primary|Maximum Plasma Concentration (Cmax) of Simeprevir|The Cmax is the maximum observed plasma concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF. Here, “Number of Participants Analyzed” signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2578989|NCT02421211|Primary|Minimum Plasma Concentration (Cmin) of Simeprevir (SMV)|The Cmin is the minimum observed plasma concentration.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, and 24 hours post-dose on Day 14 and Day 28|The ITT analysis set is defined as all participants who took at least 1 dose of SMV, LDV, or SOF.|||nanogram per Milliliters (ng/mL)||Standard Deviation|Mean
2578990|NCT02421172|Secondary|Total Interleukin-17A (IL-17A Homodimer) in Serum at Pre-dose and Post-dose for Period 1 & Period 2|Total Interleukin-17A (IL-17A homodimer) in serum at Pre-dose Period 1 (Day 1) & Pre-dose Period 2 (Day 113) and Post-dose Period 1 (Day 99) and Post-dose Period 2 (Day 211)|Pre-dose (Period 1 Day 1 & Period 2 Day 113), Post-dose Period 1(Day 99) and post-dose Period 2 (Day 211)|PK analysis set 1 includes all patients who were CJM112-treated in Period 1 with available PK data & no protocol deviations with relevant impact on PK data. PK analysis set 2 & 3 includes all patients from safety analysis set 2 & set 3 with available PK data & no protocol deviations with relevant impact on PK data for Period 2/End of Study.|||pg/mL||Standard Deviation|Mean
2578991|NCT02421172|Secondary|Immunogenicity - Incidence of ADA-positive and ADA-negative in Participants With or Without Pre-existing Antibodies in Period 1 and Period 2/End of Study|Immunogenicity - Incidence of semi-quantitative determination of anti-CJM112 antibodies or ADAs. ADA-positive and ADA-negative in participants with or without pre-existing antibodies Period 1 (week 16) and Period 2/End of Study (week 44)|Week 16 (period 1), Week 44 (End of Study Period 2)|PK analysis set 1 includes all patients who were CJM112-treated in Period 1 with available PK data & no protocol deviations with relevant impact on PK data. PK analysis set 2 & 3 includes all patients from safety analysis set 2 & set 3 with available PK data & no protocol deviations with relevant impact on PK data for Period 2/End of Study.|||participants|||Number
2578992|NCT02421172|Secondary|Pharmacokinetic Profile: T1/2 The Terminal Elimination Half-life for Period 1 & Period 2/End of Study|T1/2 The terminal elimination half-life for Period 1 (Week 16) and Period 2/End of Study (Week 44)|Week 16 (period 1), Week 44 (End of Study Period 2)|PK analysis set 1 includes all patients who were CJM112-treated in Period 1 with available PK data & no protocol deviations with relevant impact on PK data. PK analysis set 2 & 3 includes all patients from safety analysis set 2 & set 3 with available PK data & no protocol deviations with relevant impact on PK data for Period 2/End of Study.|||days||Standard Deviation|Mean
2578993|NCT02421172|Secondary|Pharmacokinetics (PK): Ctrough for CJM112 Period 1 and Period 2|Ctrough is the serum concentration that is just prior to the beginning of, or at the end, of a dosing interval (mass/volume) for Period 1 (week 16) and Period 2/End of Study (week 44)|Week 16 and Week 44|PK analysis set 1 includes all patients who were CJM112-treated in Period 1 with available PK data & no protocol deviations with relevant impact on PK data. PK analysis set 2 & 3 includes all patients from safety analysis set 2 & set 3 with available PK data & no protocol deviations with relevant impact on PK data for Period 2/End of Study.|||ug/mL||Standard Deviation|Mean
2578994|NCT02421172|Secondary|Clinical Responder Rate Period 1 at Week 2, 4, 8 and 12|Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score A HS-PGA responder in Period 1 is a study participant who had an initial HS-PGA score of at least 3 at Baseline (Day 1, inclusion criterion) that decreased by at least 2 points. The six-point Physician Global Assessment (PGA) (scores range from 0-5) based on the number of HS lesions ranges from clear to very severe.|Week 2, 4, 8 and 12|PD analysis set 1 includes all patients who were CJM112-treated or placebo-treated in Period 1 with available PD data and no protocol deviations with relevant impact on PD data in Period 1.|||count of participants|||Number
2578995|NCT02421172|Primary|Clinical Responder Rate at Period 1: Week 16|Proportion of study participants achieving a clinical response in Hidradenitis Suppurativa - Physician Global Assessment (HS-PGA) score An HS-PGA responder in period 1 was a participant who had an initial HS-PGA score of at least 3 at baseline (Day 1, inclusion criterion) that decreased by at least 2 points. The six-point Physician Global Assessment (PGA) (scores range from 0-5) based on the number of HS lesions ranges from clear to very severe.|Week 16|PD analysis set 1 includes all patients who were CJM112-treated or placebo-treated in Period 1 with available PD data and no protocol deviations with relevant impact on PD data in Period 1.|||participants|||Number
2578996|NCT02421146|Secondary|Cognition on the RBANS ( Repeatable Battery for the Assessment of Neuropsychological Status) Scale. Change Between 26th Day and Baseline.|"Standard neuropsychological assessment taking approximately 30 minutes. We report here the total score ndifference between 26th day and baseline. Scores at 26th day and at baseline are calculated according to the RBANS standards as the following: five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score. The Total Score is expressed as a standardized score normalized to a population mean of 100, with a standard deviation of 15 (possible scores 40-135). Higher scores reflect better performance. For the detailed procedures and ranges please see: Randolph C, Tierney MC, Mohr E, Chase TN (June 1998). The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 20 (3): 310-9. doi:10.1076/jcen.20.3.310.823. PMID 9845158. It is a simple delta score: calculating the difference between 26th day and baseline."|baseline (0th day), 26th day||||units on a scale||Standard Deviation|Mean
2578997|NCT02421146|Primary|Cognition on the RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) Scale|"Standard neuropsychological assessment taking approximately 30 minutes. We report here the total score ndifference between 12th day and baseline. Scores at 12th day and at baseline are calculated according to the RBANS standards as following: five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score. The Total Score is expressed as a standardized score normalized to a population mean of 100, with a standard deviation of 15 (possible scores 40-135). Higher scores reflect better performance. For the detailed procedures and ranges please see: Randolph C, Tierney MC, Mohr E, Chase TN (June 1998). The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 20 (3): 310-9. doi:10.1076/jcen.20.3.310.823. PMID 9845158. It is a simple delta score: calculating the difference between 12th day and baseline."|baseline (0th day), 12th day|We calculated differences in the cognitive measure (RBANS TScore) before and after tDCS treatment.|||units on a scale||Standard Deviation|Mean
2578998|NCT02421120|Secondary|Safety and Tolerability (Changes in Serum Chemistry, Hematology and Hepatic Lab Values, as Well as Reported Adverse Events)|This outcome will assess the safety and tolerability of ceftolozane/tazobactam in adults with CF after 4-6 doses, as measured by changes in serum chemistry, hematology and hepatic lab values, as well as reported adverse events by patients and providers.|3 days|||||||
2579329|NCT02417376|Secondary|Change From Baseline WBC Profile at 3 Months|Change from baseline in white blood cell profile assessed at 3 months.|Baseline and 3 months||||per cmm||Standard Deviation|Mean
2578999|NCT02421120|Secondary|Ceftolozane Probability of Target Attainment at 8 mcg/ml|This simulated outcome indicates the likelihood that ceftolozane will retain drug concentrations above the MIC for >/= 60% of the dosing interval at an MIC of 8 mcg/ml when administered as a 3g (2g ceftolozane/1g tazobactam) every 8 hour dose infused over 1 hour. This analysis is conducted via a Monte Carlo simulation using the population pharmacokinetic parameter estimates and dispersion from the 20 participants who contributed pharmacokinetic data to the study.|24 hours|The results of this analysis are based on 5000 simulated patients with the same pharmacokinetics to the 20 enrolled participants.|||percent of simulated population|||Number
2579000|NCT02421120|Primary|Tazobactam Volume of Distribution (Central Compartment)|This outcome determines the volume of distribution of tazobactam over the 8 hour dosing interval.|0, 1-1.08, 1.25-1.5, 2-3, 4-5, and 7-8 hours after start of final dose||||Liters||Standard Deviation|Mean
2579001|NCT02421120|Primary|Tazobactam Clearance|This outcome determines the clearance of tazobactam over the 8 hour dosing interval.|0, 1-1.08, 1.25-1.5, 2-3, 4-5, and 7-8 hours after start of final dose||||Liters per hour||Standard Deviation|Mean
2579002|NCT02421120|Primary|Ceftolozane Volume of Distribution (Central Compartment)|This outcome determines the volume of distribution of ceftolozane over the 8 hour dosing interval.|0, 1-1.08, 1.25-1.5, 2-3, 4-5, and 7-8 hours after start of final dose||||Liters||Standard Deviation|Mean
2579003|NCT02421120|Primary|Ceftolozane Clearance|This outcome determines the clearance of ceftolozane over the 8 hour dosing interval.|0, 1-1.08, 1.25-1.5, 2-3, 4-5, and 7-8 hours after start of final dose||||Liters per hour||Standard Deviation|Mean
2579004|NCT02420951|Secondary|"Quadriceps Strength Measured Using a Biodex Handheld Dynamometer"|Quadriceps strength after surgery, as measured by a Biodex handheld dynamometer.|7 days|Data were not collected.||||||
2579005|NCT02420951|Secondary|Proprioception Measured Using a SD Balancer|Proprioception measured after surgery, as measured by an SD balancer.|7 days|Data were not collected.||||||
2579006|NCT02420951|Secondary|Swelling Measured Using a Perometer|Swelling in the affected TKR joint, as measured by a perometer.|7 days|Data were not collected.||||||
2579007|NCT02420951|Secondary|Pain Med Consumption Assessed Using Questionnaire/Hospital Records|Total pain medications consumed by the patient, determined through the patients' own records in the questionnaire as well as hospital records of pain med administration and prescription.|7 days|Data were not collected.||||||
2579008|NCT02420951|Secondary|Pain Med Consumption Assessed Using Questionnaire/Hospital Records|Questionnaire/Hospital Records - While patients are in the hospital, pain medication consumption will be tracked in their electronic medical record. At home, patients will be asked to keep a log of pain medication consumption. They will be asked to record this information on a questionnaire at their first post-operative visit.|2 days||||morphine milligram equivalents (mgs)||Full Range|Mean
2579009|NCT02420951|Primary|Pain Assessed Using the VAS 0-10 Pain Scale|Pain will be assessed using the VAS 0-10 pain scale. 0 is no pain and 10 in worst imaginable pain.|7 days||||units on a scale||Full Range|Mean
2579010|NCT02420873|Primary|Overall Response Rate (ORR) of IMGN901 in Participants CD56 Expressing Hematological Malignancies|ORR, defined as CR (complete remission) + CRp (complete remission with incomplete platelet recovery) + CRi (complete remission with incomplete count recovery) within 3 cycles of therapy with IMGN901.|53 days|Zero participants were registered on Cohort 2 (Myelofibrosis arm) or Cohort 3 (Blastic Plasmacytoid Dendritic Cell Neoplasm arm).|||Participants|||Count of Participants
2579011|NCT02420821|Secondary|Cmin for Bevacizumab|Cmin for bevacizumab was estimated from plasma concentration versus time data.|Pre-dose (Hour 0) on Day 1 of Cycle 3 (Cycle length = 42 days)|Analysis was performed on the Bevacizumab PK Population. Here, 'Overall Number of Participants Analyzed’ = number of participants evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2579012|NCT02420821|Secondary|Cmax for Bevacizumab|Cmax for bevacizumab was estimated from plasma concentration versus time data.|30 minutes after the end of bevacizumab infusion (atezolizumab infusion duration: 30-60 min; bevacizumab infusion duration: 30-90 minutes) on Day 1 of Cycle 1 (Cycle length = 42 days)|Analysis was performed on the Bevacizumab PK Population, which included all participants who received bevacizumab treatment and had evaluable PK samples. Here, 'Overall Number of Participants Analyzed’ = number of participants evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2579013|NCT02420821|Secondary|Minimum Observed Serum Concentration (Cmin) for Atezolizumab|Cmin for atezolizumab was estimated from plasma concentration versus time data.|Predose (Hour 0) on Day 22 of Cycle 1; predose (Hour 0) on Day 1 of Cycles 2; Cycle length = 42 days|Analysis was performed on the Atezolizumab PK Population. Here, 'Overall Number of Participants Analyzed’ = number of participants evaluable for this outcome measure; 'Number Analyzed' = number of participants evaluable at specified time point.|||mcg/mL||Standard Deviation|Mean
2579014|NCT02420821|Secondary|Maximum Observed Serum Concentration (Cmax) for Atezolizumab|Cmax for atezolizumab was estimated from plasma concentration versus time data.|30 minutes after the end of bevacizumab infusion (atezolizumab infusion duration: 30-60 min; bevacizumab infusion duration: 30-90 minutes) on Day 1 of Cycle 1 (Cycle length = 42 days)|Analysis was performed on the Atezolizumab Pharmacokinetic (PK) Population, which included all participants who received atezolizumab treatment and had evaluable PK samples. Here, 'Overall Number of Participants Analyzed’ = number of participants evaluable for this outcome measure.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
2579015|NCT02420821|Secondary|Number of Participants With ATAs Against Bevacizumab|"The number of participants with Treatment-induced ATAs and Treatment-enhanced ATA against bevacizumab at any time during or after treatment was reported. Treatment-induced ATA = a participant with negative or missing Baseline ATA result(s) and at least one positive post-Baseline ATA result. Treatment-enhanced ATA = a participant with positive ATA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result."|Baseline (Predose [Hour 0] at Day 1 Cycle 1); Post-Baseline (Predose at Cycle 3, at EoT [up to approximately 27 months] and at 120 days after EoT [up to approximately 27 months]) (Cycle length=42 days)|Analysis was performed on the ATA-Evaluable Population. Here, 'Overall Number of Participants Analyzed’ = number of participants with a non-missing baseline ATA sample; 'Number Analyzed' = number of participants with a non-missing ATA sample at indicated timepoint.|||participants|||Number
2595588|NCT02220920|Secondary|Change in Blood Pressure||baseline and Week 16|Full analysis set, last observation carried forward|||mmHg||Standard Error|Least Squares Mean
2579016|NCT02420821|Secondary|Number of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab|"The number of participants with Treatment-induced ATAs and Treatment-enhanced ATA against atezolizumab at any time during or after treatment was reported. Treatment-induced ATA = a participant with negative or missing Baseline ATA result(s) and at least one positive post-Baseline ATA result. Treatment-enhanced ATA = a participant with positive ATA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result. Here, 'Overall Number of Participants Analyzed' = number of participants with a non-missing baseline ATA sample; 'Number Analyzed' = number of participants with a non-missing ATA sample at indicated timepoint."|Baseline (Predose [Hour 0] at Day 1 Cycle 1); Post-Baseline (Predose at Cycles 2, 4, and 8, and every eight cycles thereafter up to EoT [up to approximately 27 months] and 120 days after EoT [up to approximately 27 months]) (Cycle length=42 days)|Analysis was performed on the ATA-Evaluable Population, which included all participants in the Atezolizumab + Bevacizumab arm with a non-missing baseline ATA sample and >/=1 post-baseline ATA sample.|||participants|||Number
2579017|NCT02420821|Secondary|Change From Baseline in Treatment Side Effects Burden as Determined by Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19) General Population 5 (GP5) Item Score|The FKSI-19 is a 19-item tool designed to assess the most important symptoms and concerns related to treatment effectiveness in advanced kidney cancer. The FKSI-19 GP5 item (bothered by the side effect of treatment) assessed side effects burden in the past 7 days on a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Repeated measures model-estimated LS mean score for changes from baseline is reported at each timepoint, where a negative value indicates improvement.|Day 1 and 22 of every cycle (Baseline = Day 1 Cycle 1) up to Cycle 19; Cycle length = 42 days|Analysis was performed on the PRO-Evaluable Population. Here, 'Number Analyzed' = number of participants evaluable at specified time point.|||units on a scale||Standard Error|Least Squares Mean
2579018|NCT02420821|Secondary|Change From Baseline in Symptom Severity as Determined by BFI Worst Fatigue Item|The BFI is a valid and reliable self-report questionnaire used to assess the severity and impact of cancer-related fatigue. BFI worst fatigue item assessed the severity of fatigue at its worst in the last 24 hours. The item was rated on a scale of 0 (not present) to 10 (as bad as you can imagine). Change from baseline in the score at each time point is reported, where a negative value indicates improvement.|Baseline (Day 1 Cycle 1); every week for first 12 weeks, Days 1 and 22 of each cycle (Cycle 3 up to 19), within 30 days of PD (up to 27 months), at EoT (up to 27 months) and at 6, 12, 24, and 36 weeks after EoT (overall up to 27 months); 1 cycle=42 days|Analysis was performed on the PRO-Evaluable Population. Here, 'Overall Number of Participants Analyzed’ = number of participants evaluable for this outcome measure; 'Number Analyzed' = number of participants evaluable at specified time point.|||units on a scale||Standard Deviation|Mean
2579019|NCT02420821|Secondary|Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI) Interference Scale Score|The BFI is a valid and reliable self-report questionnaire used to assess the severity and impact of cancer-related fatigue. BFI interference subscale (6 items) assessed the impact of fatigue on global domains (general activity, mood, walking ability, normal work, relations with other people, and enjoyment of life) in the last 24 hours. Each item was rated on a scale of 0 (does not interfere) to 10 (interfered completely). Change from baseline in the mean score of all 6 items at each timepoint is reported, where a negative value indicates improvement.|Baseline (Day 1 Cycle 1); every week for first 12 weeks, Days 1 and 22 of each cycle (Cycle 3 up to 19), within 30 days of PD (up to 27 months), at EoT (up to 27 months) and at 6, 12, 24, and 36 weeks after EoT (overall up to 27 months); 1 cycle=42 days|Analysis was performed on the PRO-Evaluable Population. Here, 'Overall Number of Participants Analyzed’ = number of participants evaluable for this outcome measure; 'Number Analyzed' = number of participants evaluable at specified time point.|||units on a scale||Standard Deviation|Mean
2579020|NCT02420821|Secondary|Change From Baseline in Symptom Severity as Determined by MDASI Part I Score|"The MDASI is a cancer-related, multi-symptom, valid, and reliable self-report questionnaire that comprises of 23 items and two subscales: symptom severity (17 items) and symptom interference (6 items). In Part I, participants were asked to rate how severe the symptoms (pain, fatigue, nausea, disturbed sleep, feeling of being distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, feeling sad, vomiting, numbness or tingling, rash/skin changes, headache, mouth/throat sores, and diarrhea) were when at their worst in the last 24 hours. Each item was rated on a scale of 0 (not present) to 10 (as bad as you can imagine). Mixed-effects model-estimated LS mean score for change from baseline at the end-of treatment is reported for each item, where a negative value indicates improvement."|Baseline; End of Treatment (EoT) visit (up to approximately 27 months)|Analysis was performed on the PRO-Evaluable Population. Here, 'Overall Number of Participants Analyzed’ = number of participants evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2579021|NCT02420821|Secondary|Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II Score|The MDASI is a cancer-related, multi-symptom, valid, and reliable self-report questionnaire that comprises of 23 items and two subscales: symptom severity (17 items) and symptom interference (6 items). In Part II, participants were asked to rate how much the symptoms have interfered with 6 areas of function (general activity, walking, work, mood, relations with other people, and enjoyment of life) in the last 24 hours. Each item was rated on a scale of 0 (does not interfere) to 10 (interfered completely) and total Part II score was calculated as an average of 6-item scores. Repeated measures model-estimated least-squares (LS) mean score for changes from baseline is reported at each timepoint, where a negative value indicates improvement. Here, 'Number Analyzed' = number of participants evaluable at specified time point.|Baseline (Day 1 Cycle 1); Day 22 Cycle 1; Day 1 and 22 of every cycle from Cycle 2 up to Cycle 19; Cycle length = 42 days|Analysis was performed on the patient-reported outcome (PRO)-Evaluable Population, which included all participants with a non-missing baseline PRO assessment and >/=1 post-baseline PRO assessment.|||units on a scale||Standard Error|Least Squares Mean
2579077|NCT02420353|Secondary|Absolute Isometric Extension (Nm) at Pre-op (Baseline)|Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used.|at pre-op (baseline)|A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm).|||Nm||90% Confidence Interval|Mean
2579022|NCT02420821|Secondary|OS in Participants With Sarcomatoid Histology|OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|Baseline until death from any cause (until data cut-off date 29 September 2017, up to approximately 27 months)|Analysis was performed on the ITT Population participants with sarcomatoid histology.|||months||95% Confidence Interval|Median
2579023|NCT02420821|Secondary|Percentage of Participants Who Died of Any Cause in Participants With Sarcomatoid Histology|Percentage of participants who died of any cause was reported.|Baseline until death from any cause (until data cut-off date 29 September 2017, up to approximately 27 months)|Analysis was performed on the ITT Population participants with sarcomatoid histology.|||percentage of participants|||Number
2579024|NCT02420821|Secondary|PFS as Determined by the Investigator According to RECIST v1.1 in Participants With Sarcomatoid Histology|PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)|Analysis was performed on the ITT Population participants with sarcomatoid histology.|||months||95% Confidence Interval|Median
2579025|NCT02420821|Secondary|Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in Participants With Sarcomatoid Histology|Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs.|Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)|Analysis was performed on the ITT Population participants with sarcomatoid histology (defined by investigator-assessed conventional histopathology).|||percentage of participants|||Number
2579026|NCT02420821|Secondary|PFS as Determined by the Investigator According to RECIST v1.1 in ITT Population|PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Participants with a PFS event who missed >/=2 scheduled assessments immediately prior to the PFS event were censored at the last tumor assessment prior to the missed visits. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)|Analysis was performed on the ITT Population.|||months||95% Confidence Interval|Median
2579027|NCT02420821|Secondary|Percentage of Participants With PD as Determined by the Investigator According to RECIST v1.1 or Death From Any Cause in ITT Population|Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs.|Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)|Analysis was performed on the ITT Population.|||percentage of participants|||Number
2579028|NCT02420821|Secondary|DOR as Determined by the Investigator According to Immune-Modified RECIST in DOR-Evaluable Population|DOR was defined as the time from the first occurrence of CR/PR to PD as determined by the investigator per immune-modified RECIST or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs or reduction in short axis of any pathological lymph nodes to <10 mm. PR: >/=30% decrease in the SoD of TLs and all new measurable lesions (taking as reference the baseline SoD), in the absence of CR. PD: >/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley.|Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)|Analysis was performed on DOR-Evaluable Population.|||months||95% Confidence Interval|Median
2579029|NCT02420821|Secondary|Percentage of Participants With an Objective Response of CR or PR as Determined by the Investigator According to Immune-Modified RECIST in ORR-Evaluable Population|Tumor response was assessed by the investigator according to immune-modified RECIST. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs or reduction in short axis of any pathological lymph nodes to <10 mm. PR was defined as >/=30% decrease in the SoD of TLs and all new measurable lesions (taking as reference the baseline SoD), in the absence of CR. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders.|Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)|Analysis was performed on the ORR-Evaluable Population.|||percentage of participants||95% Confidence Interval|Number
2579124|NCT02420015|Secondary|Number of Participants Who Report 30 Day Point Prevalence Abstinence|Secondary smoking outcomes will include 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 30 days.|6 months post-quit attempt (Session 6)||||Participants|||Count of Participants
2601685|NCT02150837|Secondary|Waist Circumference|Waist circumference expressed as an absolute change from baseline.|16 weeks||||Inches||Standard Deviation|Mean
2579030|NCT02420821|Secondary|PFS as Determined by the Investigator According to Immune-Modified RECIST in ITT Population|PFS was defined as the time from randomization to PD, as determined by the investigator per immune-modified RECIST or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)|Analysis was performed on the ITT Population.|||months||95% Confidence Interval|Median
2579031|NCT02420821|Secondary|Percentage of Participants With PD as Determined by the Investigator According to Immune-Modified RECIST or Death From Any Cause in ITT Population|Tumor response was assessed by the investigator according to immune-modified RECIST. PD was defined as >/=20% relative increase in the SoD of all TLs and all new measurable lesions, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm.|Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)|Analysis was performed on the ITT Population.|||percentage of participants|||Number
2579032|NCT02420821|Secondary|DOR as Determined by an IRC According to RECIST v1.1 in DOR-Evaluable Population|DOR was defined as the time from the first occurrence of CR/PR to PD as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs and normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to <10 mm. PR: >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or maintenance of tumor marker level above the normal limits. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley.|Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)|Analysis was performed on the DOR-Evaluable Population.|||months||95% Confidence Interval|Median
2579033|NCT02420821|Secondary|Percentage of Participants With an Objective Response of CR or PR as Determined by an IRC According to RECIST v1.1 in ORR-Evaluable Population|Tumor response was assessed by an IRC according to RECIST v1.1. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs and (if applicable) normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to <10 mm. PR was defined as >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders.|Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)|Analysis was performed on the ORR-Evaluable Population.|||percentage of participants||95% Confidence Interval|Number
2579034|NCT02420821|Secondary|Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1 in DOR-Evaluable Population|DOR was defined as the time from the first occurrence of CR/PR to PD as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurred first. CR: disappearance of TLs/non-TLs and normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to <10 mm. PR: >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or maintenance of tumor marker level above the normal limits. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PD or death after a CR/PR were censored at last tumor assessment. Participants without tumor assessments after a CR/PR were censored at first CR/PR + 1 day. Median DOR was estimated by Kaplan-Meier method and 95% CI by the method of Brookmeyer and Crowley.|Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)|Analysis was performed on DOR-Evaluable Population, which included all participants with a CR/PR in the ORR-Evaluable Population.|||months||95% Confidence Interval|Median
2579035|NCT02420821|Secondary|Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by the Investigator According to RECIST v1.1 in Objective Response Rate (ORR)-Evaluable Population|Tumor response was assessed by the investigator according to RECIST v1.1. Objective response was defined as percentage of participants with a documented CR or PR. CR was defined as disappearance of all TLs/non-TLs and (if applicable) normalization of tumor marker level or reduction in short axis of any pathological lymph nodes to less than (<) 10 mm. PR was defined as >/=30% decrease in the SoD of TLs (taking as reference the baseline SoD) or persistence of >/=1 non-TL(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. The 95% CI was computed using Clopper-Pearson approach. Participants without any post-baseline tumor assessments were considered non-responders.|Baseline until documented CR/PR, PD, or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)|Analysis was performed on the ORR-Evaluable Population, which included all participants in the ITT population with measurable disease at baseline, as determined by the investigator.|||percentage of participants||95% Confidence Interval|Number
2579078|NCT02420353|Secondary|Absolute Isokinetic Flexion (Nm) at 26 Weeks Post-op|Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used.|at 26 weeks post-op|A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups.|||Nm||90% Confidence Interval|Mean
2579036|NCT02420821|Secondary|PFS as Determined by an IRC According to RECIST v1.1 in PD-L1-Selected Population|PFS was defined as the time from randomization to PD, as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)|Analysis was performed on the PD-L1-Selected Population.|||months||95% Confidence Interval|Median
2579037|NCT02420821|Secondary|Percentage of Participants With PD as Determined by an IRC According to RECIST v1.1 or Death From Any Cause in PD-L1-Selected Population|Tumor response was assessed by an IRC according to RECIST v1.1. PD was defined as >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs.|Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)|Analysis was performed on the PD-L1-Selected Population.|||percentage of participants|||Number
2579038|NCT02420821|Secondary|PFS as Determined by an IRC According to RECIST v1.1 in ITT Population|PFS was defined as the time from randomization to PD, as determined by an IRC per RECIST v1.1, or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Median PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)|Analysis was performed on the ITT Population.|||months||95% Confidence Interval|Median
2579039|NCT02420821|Secondary|Percentage of Participants With PD as Determined by an Independent Review Committee (IRC) According to RECIST v1.1 or Death From Any Cause in ITT Population|Tumor response was assessed by an IRC according to RECIST v1.1. PD was defined as >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs.|Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)|Analysis was performed on the ITT Population.|||percentage of participants|||Number
2579040|NCT02420821|Secondary|OS in PD-L1-Selected Population|OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|Baseline until death from any cause (until data cut-off date 29 September 2017, up to approximately 27 months)|Analysis was performed on the PD-L1-Selected Population.|||months||95% Confidence Interval|Median
2579041|NCT02420821|Secondary|Percentage of Participants Who Died of Any Cause in PD-L1-Selected Population|Percentage of participants who died of any cause was reported.|Baseline until death from any cause (until data cut-off date 29 September 2017, up to approximately 27 months)|Analysis was performed on the PD-L1-Selected Population.|||percentage of participants|||Number
2579042|NCT02420821|Primary|Overall Survival (OS) in ITT Population|OS was defined as the time from randomization to death due to any cause. Participants who were not reported as having died at the date of analysis were censored at the date when they were last known to be alive. Participants who did not have post-baseline information were censored at the date of randomization + 1 day. Median OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|Baseline until death from any cause (until data cut-off date 29 September 2017, up to approximately 27 months)|Analysis was performed on the ITT Population.|||months||95% Confidence Interval|Median
2579043|NCT02420821|Primary|Percentage of Participants Who Died of Any Cause in ITT Population|Percentage of participants who died of any cause was reported.|Baseline until death from any cause (until data cut-off date 29 September 2017, up to approximately 27 months)|Analysis was performed on the ITT Population.|||percentage of participants|||Number
2579044|NCT02420821|Primary|Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population|PFS was defined as the time from randomization to PD, as determined by the investigator per RECIST v1.1, or death from any cause, whichever occurred first. PD: >/=20% relative increase in the SoD of all TLs, taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 mm; >/=1 new lesion(s); and/or unequivocal progression of non-TLs. Participants without PFS event were censored at the last tumor assessment date. Participants with no post-baseline tumor assessments were censored at the randomization date + 1 day. Participants with a PFS event who missed >/=2 scheduled assessments immediately prior to the PFS event were censored at the last tumor assessment prior to the missed visits. Median PFS was estimated by Kaplan-Meier method and 95% confidence interval (CI) was assessed using the method of Brookmeyer and Crowley.|Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)|Analysis was performed on the PD-L1-Selected Population.|||months||95% Confidence Interval|Median
2579058|NCT02420353|Secondary|KOOS Patient Reported Outcome Measure: Symptoms at Pre-op (Baseline)|"KOOS Symptoms (7 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately.~Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures"|at pre-op (baseline)|A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.|||score on a scale||90% Confidence Interval|Mean
2579045|NCT02420821|Primary|Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population|Tumor response was assessed by the investigator according to RECIST v1.1. Disease Progression (PD) was defined as greater than or equal to (>/=) 20 percent (%) relative increase in the sum of diameters (SoD) of all target lesions (TLs), taking as reference the smallest SoD on study, including baseline, and an absolute increase of >/=5 millimeters (mm); >/=1 new lesion(s); and/or unequivocal progression of existing non-TLs.|Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)|Analysis was performed on the PD-L1-Selected Population, which included all participants in the ITT population whose PD-L1 status was immune cell (IC)1/2/3 at the time of randomization.|||percentage of participants|||Number
2579046|NCT02420353|Secondary|Hyaluronic Acid at -1 and 5 Weeks Post-op|Hyaluronic acid was measured from plasma using ELISAs (R&D Systems, Minneapolis, MN) following manufacturer recommendations.|Area under the curve between -1 and 5 weeks post-op|Blood was drawn from the antecubital vein from each patient at specific time points, plasma and serum were prepared from whole blood and stored at -80ºC.|||ng*days/mL||90% Confidence Interval|Mean
2579047|NCT02420353|Secondary|MMP3 at -1 and 5 Weeks Post-op|Matrix metalloproteinase-3 (MMP3) was measured from serum using ELISAs (R&D Systems, Minneapolis, MN) following manufacturer recommendations.|Area under the curve between -1 and 5 weeks post-op|Blood was drawn from the antecubital vein from each patient at specific time points, plasma and serum were prepared from whole blood and stored at -80ºC.|||ng*days/mL||90% Confidence Interval|Mean
2579048|NCT02420353|Secondary|Myostatin at -1 and 5 Weeks Post-op|Myostatin was measured from plasma using ELISAs (R&D Systems, Minneapolis, MN) following manufacturer recommendations.|Area under the curve between -1 and 5 weeks post-op|Blood was drawn from the antecubital vein from each patient at specific time points, plasma and serum were prepared from whole blood and stored at -80ºC.|||ng*days/mL||90% Confidence Interval|Mean
2579049|NCT02420353|Secondary|Insulin Like Growth Factor (IGF1) at -1 and 5 Weeks Post-op|IGF1 was measured from serum using an IMMULITE 2000 system (Siemens).|Area under the curve between -1 and 5 weeks post-op|Blood was drawn from the antecubital vein from each patient at specific time points, plasma and serum were prepared from whole blood and stored at -80ºC.|||ng*days/mL||90% Confidence Interval|Mean
2579050|NCT02420353|Secondary|Normalized Hamstring Volume (L) at 26 Weeks Post-op|Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).|at 26 weeks post-op|Scans were performed on a total of 19 participant at three time points throughout the study.|||Liters||90% Confidence Interval|Mean
2579051|NCT02420353|Secondary|Normalized Hamstring Volume (L) at Pre-op (Baseline)|Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).|at pre-op (baseline)|Scans were performed on a total of 19 participant at three time points throughout the study.|||Liters||90% Confidence Interval|Mean
2579052|NCT02420353|Secondary|Normalized Quadriceps Volume (L) at 26 Weeks Post-op|Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).|at 26 weeks post-op|Scans were performed on a total of 19 participant at three time points throughout the study.|||Liters||90% Confidence Interval|Mean
2579053|NCT02420353|Secondary|Normalized Quadriceps Volume (L) at Pre-op (Baseline)|Normalized volume relative to the pre-op measurements of the uninjured limb, used to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).|at pre-op (baseline)|Scans were performed on a total of 19 participant at three time points throughout the study.|||Liters||90% Confidence Interval|Mean
2579054|NCT02420353|Secondary|Absolute Hamstring Volume (L) at 26 Weeks Post-op|Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).|at 26 weeks post-op|Scans were performed on a total of 19 participant at three time points throughout the study.|||Liters||90% Confidence Interval|Mean
2579055|NCT02420353|Secondary|Absolute Hamstring Volume (L) at Pre-op (Baseline)|Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).|at pre-op (baseline)|Scans were performed on a total of 19 participant at three time points throughout the study.|||Liters||90% Confidence Interval|Mean
2579056|NCT02420353|Secondary|Absolute Quadricep Volume (L) at 26 Week Post-op|Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).|at 26 week post-op|Scans were performed on a total of 19 participant at three time points throughout the study.|||Liters||90% Confidence Interval|Mean
2579057|NCT02420353|Secondary|Absolute Quadriceps Volume (L) at Pre-op (Baseline)|Bilateral MRI scans were obtained at specific time points to assess the muscle volume of the quadriceps and hamstring muscle groups will be calculated using GE ImagePACS software (FDA cleared software which is the standard software used to read and analyze imaging studies in the UMHS).|at pre-op (baseline)|Scans were performed on a total of 19 participant at three time points throughout the study.|||Liters||90% Confidence Interval|Mean
2579121|NCT02420041|Primary|Change in Pain Score From Baseline to 2 Weeks Post-procedure Using the DoD/VA PRS|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.|2 weeks post-procedure minus baseline||||units on a scale||Full Range|Mean
2579059|NCT02420353|Secondary|KOOS Patient Reported Outcome Measure: Symptoms at 26 Weeks Post-op|"KOOS Symptoms (7 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately.~Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures"|at 26 weeks post-op|A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.|||score on a scale||90% Confidence Interval|Mean
2579060|NCT02420353|Secondary|KOOS Patient Reported Outcome Measure: Sports and Recreation at Pre-op (Baseline)|"KOOS Sport and Recreation (Sport/Rec) (5 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately.~Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures."|at pre-op (baseline)|A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.|||score on a scale||90% Confidence Interval|Mean
2579061|NCT02420353|Secondary|KOOS Patient Reported Outcome Measure: Sport and Recreation at 26 Weeks Post-op|"KOOS Sport and Recreation (Sport/Rec) (5 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately.~Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures."|at 26 weeks post-op|A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.|||score on a scale||90% Confidence Interval|Mean
2579062|NCT02420353|Secondary|KOOS Patient Reported Outcome Measure: Quality of Life at Pre-op (Baseline)|"KOOS Quality of Life (QoL) (4 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately.~Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures"|at pre-op (baseline)|A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.|||score on a scale||90% Confidence Interval|Mean
2579063|NCT02420353|Secondary|KOOS Patient Reported Outcome Measure: Quality of Life at 26 Weeks Post-op|"KOOS Quality of Life (QoL) (4 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately.~Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures"|at 26 weeks post-op|A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.|||score on a scale||90% Confidence Interval|Mean
2579064|NCT02420353|Secondary|KOOS Patient Reported Outcome Measure: Pain at Pre-op (Baseline)|"KOOS Pain (9 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately.~Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures"|at pre-op (baseline)|A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.|||score on a scale||90% Confidence Interval|Mean
2579065|NCT02420353|Secondary|KOOS Patient Reported Outcome Measure: Pain at 26 Weeks Post-op|"KOOS Pain (9 items) A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately.~Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures"|at 26 weeks post-op|A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.|||score on a scale||90% Confidence Interval|Mean
2579066|NCT02420353|Secondary|KOOS Patient Reported Outcome Measure: ADL at Pre-op (Baseline)|"KOOS Function in daily living (ADL) (17 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately.~Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures"|at pre-op (baseline)|A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.|||score on a scale||90% Confidence Interval|Mean
2579330|NCT02417376|Secondary|Change From Baseline WBC Profile at 1 Month|Change from baseline in white blood cell profile assessed at 1 month.|Baseline and 1 month||||per cmm||Standard Deviation|Mean
2579067|NCT02420353|Secondary|The Knee Injury and Osteoarthritis Outcome Score (KOOS): Patient Reported Outcome Measure: ADL at 26 Weeks Post-op|"KOOS Function in daily living (ADL) (17 items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. An aggregate total score is not calculated since it is regarded desirable to analyze and interpret the five dimensions separately.~Maximum score 100% / Minimum score 0%. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures"|at 26 weeks post-op|A total of 19 participants were administered the KOOS survey, this 42 part questionnaire is then score in five parts based on the answers selected by the subjects.|||score on a scale||90% Confidence Interval|Mean
2579068|NCT02420353|Secondary|International Knee Documentation Committee (IKDC) up to 26 wk Post-op|The IKDC percentage score is a subjective patients reported outcome measure (PROM) that scores a participants over all score. The PROM looks at 3 categories: symptoms, sports activity, and knee function. Scores range from 0 to 100, the final score given is interpreted as a measure of function with higher scores representing higher levels of function.|up to 26 wk post-op|A total of 19 participants complete the IKDC outcome measure, the form was administer by hand at the time of the study visits for each study timepoint.|||units on a scale||90% Confidence Interval|Mean
2579069|NCT02420353|Secondary|International Knee Document Committee (IKDC) at Pre-op (Baseline)|The IKDC percentage score is a subjective patients reported outcome measure (PROM) that scores a participants over all score. The PROM looks at 3 categories: symptoms, sports activity, and knee function. Scores range from 0 to 100, the final score given is interpreted as a measure of function with higher scores representing higher levels of function.|at pre-op (baseline)|A total of 19 participants complete the IKDC outcome measure, the form was administer by hand at the time of the study visits for each study timepoint.|||score on a scale||90% Confidence Interval|Mean
2579070|NCT02420353|Secondary|VR12 Health Survey: Mental Health Summary Measure Score at 26 Weeks Post-op|The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed MCS Maximum: 76.09; Minimum: -2.47.|at 26 weeks post-op|A total of 19 participants were administered the VR12 survey, this 12 part questionnaire is then score in two parts based on the answers selected by the subjects.|||T-score||90% Confidence Interval|Mean
2579071|NCT02420353|Secondary|VR12 Health Survey: Mental Health Summary Measure Score at Pre-op (Baseline)|The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed MCS Maximum: 76.09; Minimum: -2.47.|at pre-op (baseline)|A total of 19 participants were administered the VR12 survey, this 12 part questionnaire is then score in two parts based on the answers selected by the subjects.|||T-score||90% Confidence Interval|Mean
2579072|NCT02420353|Secondary|VR12 Health Survey: Physical Health Summary Measure Score at 26 Weeks Post-op|The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed PCS maximum: 72.11; minimum: 0.59.|at 26 weeks post-op|A total of 19 participants were administered the VR12 survey, this 12 part questionnaire is then score in two parts based on the answers selected by the subjects.|||T-score||90% Confidence Interval|Mean
2579073|NCT02420353|Secondary|VR12 Health Survey: Physical Health Summary Measure Score at Pre-op (Baseline)|The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed PCS maximum: 72.11; minimum: 0.59.|at pre-op (baseline)|A total of 19 participants were administered the VR12 survey, this 12 part questionnaire is then score in two parts based on the answers selected by the subjects.|||T-score||90% Confidence Interval|Mean
2579074|NCT02420353|Secondary|Absolute Isometric Flexion (Nm) at 26 Weeks Post-op|Absolute Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used.|at 26 weeks post-op|A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups.|||Nm||90% Confidence Interval|Mean
2579075|NCT02420353|Secondary|Absolute Isometric Flexion (Nm) at Pre-op (Baseline)|Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used.|at pre-op (baseline)|A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm).|||Nm||90% Confidence Interval|Mean
2579076|NCT02420353|Secondary|Absolute Isometric Extension (Nm) at 26 Weeks Post-op|Absolute Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used.|at 26 weeks post-op|A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups.|||Nm||90% Confidence Interval|Mean
2601686|NCT02150837|Secondary|Waist Circumference|Waist circumference expressed as an absolute change from baseline.|8 weeks||||Inches||Standard Deviation|Mean
2579079|NCT02420353|Secondary|Absolute Isokinetic Flexion (Nm) at Pre-op (Baseline)|Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used.|at pre-op (baseline)|A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups.|||Nm||90% Confidence Interval|Mean
2579080|NCT02420353|Secondary|Absolute Isokinetic Extension (Nm) at 26 wk Post-op|Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used.|at 26 wk post-op|A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups.|||Nm||90% Confidence Interval|Mean
2579081|NCT02420353|Secondary|Absolute Isokinetic Extension (Nm) at Pre-op (Baseline)|Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used.|at pre-op (baseline)|A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then compared between study groups.|||Nm||90% Confidence Interval|Mean
2579082|NCT02420353|Secondary|Normative Isometric Flexion (Nm) at 26 Weeks Post-op|Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.|at 26 weeks post-op|A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then normalized to the participants nonsurgical limb.|||Nm||90% Confidence Interval|Mean
2579083|NCT02420353|Secondary|Normative Isometric Flexion (Nm) at Pre-op (Baseline)|Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.|at pre-op (baseline)|A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm).|||Nm||90% Confidence Interval|Mean
2579084|NCT02420353|Secondary|Normative Isometric Extension (Nm) at 26 Weeks Post-op|Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.|at 26 weeks post-op|A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then normalized to the participants nonsurgical limb.|||Nm||90% Confidence Interval|Mean
2579085|NCT02420353|Secondary|Normative Isometric Extension (Nm) at Pre-op (Baseline)|Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.|at pre-op (baseline)|A total of 19 participants were analyzed for bilateral isometric knee strength using the BioDex system 3 results where recorded in newton meters (Nm).|||Nm||90% Confidence Interval|Mean
2579086|NCT02420353|Secondary|Normative Isokinetic Flexion (Nm) at 26 Weeks Post-op|Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.|at 26 weeks post-op|A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm), results where then normalized to the participants nonsurgical limb.|||Nm||90% Confidence Interval|Mean
2579087|NCT02420353|Secondary|Normative Isokinetic Flexion (Nm) at Pre-op (Baseline)|Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.|at pre-op (baseline)|A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm).|||Nm||90% Confidence Interval|Mean
2579088|NCT02420353|Secondary|Normative Isokinetic Extension (Nm) at Pre-op (Baseline)|Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.|at pre-op (baseline)|A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm).|||Nm||90% Confidence Interval|Mean
2579331|NCT02417376|Secondary|Change From Baseline in Lipid Profile at 6 Months.|Change from baseline in lipid profile assessed at 6 months.|Baseline and 6 months||||mg/dl||Standard Deviation|Mean
2579089|NCT02420353|Primary|Normative Isokinetic Knee Extension Strength, Measured in Newton Meters (Nm) at 26 Weeks Post-op|Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.|at 26 wks post-op|A total of 19 participants were analyzed for bilateral isokinetic knee strength using the BioDex system 3 results where recorded in newton meters (Nm).|||Nm||90% Confidence Interval|Mean
2579090|NCT02420327|Secondary|Profile of Mood Scale - Total Mood Disturbance|"Participants rate their current subjective state on a list of adjectives, which contribute to six factors/subscales. Total Mood Disturbance is a composite measure, obtained by summing the scores of all subscales, each with a range of 0-4, weighting the one positively valenced factor negatively. Thus, smaller or more negative values represent a more positive mood state. The theoretical range of the Total Mood Disturbance measure is from -4 to +20."|5 min|Healthy adult non-smokers|||score on a scale||Standard Deviation|Mean
2579091|NCT02420327|Primary|Change Detection Task Reaction Time|"The task requires encoding the color of 1 or 5 shape items and reporting whether or not one of the items changed color.~One participant's data were excluded from this task because of excessive no-response trials."|15 min|Healthy adult non-smokers|||ms||Standard Deviation|Mean
2579092|NCT02420327|Primary|Rapid Visual Information Processing Task Reaction Time|The task requires the detection of three consecutive odd or three consecutive even digits in a stream of sequentially presented digits.|30 min|Healthy adult non-smokers|||ms||Standard Deviation|Mean
2579093|NCT02420327|Primary|Spatial Attentional Resource Allocation Task (SARAT) Non-predictive Trial Reaction Time|The task requires responding to brief target stimuli presented randomly in one of four locations in the four corners of the screen. On non-predictive trial, the cue does not provide any advance information about where the target will occur.|45 min|Healthy adult non-smokers|||ms||Standard Deviation|Mean
2579094|NCT02420327|Primary|Change Detection Task Accuracy|"The task requires encoding the color of 1 or 5 shape items and reporting whether or not one of the items changed color. Accuracy refers to the percentage of all trials in which a correct response was given.~One participant's data were excluded from this task because of excessive no-response trials."|15 min|Healthy adult non-smokers|||percentage of all trials||Standard Deviation|Mean
2579095|NCT02420327|Primary|Rapid Visual Information Processing Task Hit Rate|The task requires following a stream of digits and detecting three consecutive odd or even numbers. The Hit Rate reflects the percentage of all target sequences that were detected.|30 min|Healthy adult non-smokers|||percentage of all targets||Standard Deviation|Mean
2579096|NCT02420327|Primary|Spatial Attentional Resource Allocation Task Predictive Trials Reaction Time|The task requires detecting brief target stimuli presented at one of four locations in the four corner of the screen. On predictive trials, a central cue predicts the target location.|45 min|27 healthy adult non-smokers|||ms||Standard Deviation|Mean
2579097|NCT02420262|Secondary|Responder for HbA1c Below or Equal to 6.5 %|Number of subjects with HbA1c below 6.5% after 26 weeks of treatment.|After 26 weeks of treatment|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. 14 subjects in IDegLira and 21 subjects in IGlar + IAsp arm did not contribute to the analysis for this endpoint.|||Participants|||Count of Participants
2579098|NCT02420262|Secondary|Responder for HbA1c Below 7.0%|Number of subjects with HbA1c below 7% after 26 weeks of treatment.|After 26 weeks of treatment|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. 14 subjects in IDegLira and 21 subjects in IGlar + IAsp arm did not contribute to the analysis for this endpoint.|||Participants|||Count of Participants
2579099|NCT02420262|Secondary|Change in Body Weight|Change in body weight after 26 weeks of treatment.|Week 0, Week 26|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. 08 subjects in both IDegLira and IGlar + IAsp arm did not contribute to the analysis for this endpoint.|||kg||Standard Error|Least Squares Mean
2579100|NCT02420262|Secondary|Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.|Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia.|Weeks 0-26|The safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation “as treated”. One subject in IGlar + IAsp arm did not contribute to the analysis for this endpoint.|||Number of episodes|||Number
2579101|NCT02420262|Primary|Change in HbA1c (Glycosylated Haemoglobin)|Change in HbA1c values after 26 weeks of treatment.|Week 0, Week 26|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intention-to-treat (ITT) principle and subjects contributed to the evaluation “as randomised”. 8 subjects in IDegLira and 9 subjects in IGlar + IAsp arm did not contribute to the analysis for this endpoint.|||Percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
2579102|NCT02420210|Other Pre-specified|Quality of Life Assessed Using the Functional Assessment of Cancer Therapy (FACT)-L Scale||Up to 18 weeks (at end of study treatment)|Funding for study was withdrawn after two patients were enrolled. Secondary outcomes not collected.||||||
2579103|NCT02420210|Secondary|Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Adverse events will be tabulated by type and grade.|Up to 30 days following the last administration of study treatment|Funding for study was withdrawn after two patients were enrolled. Secondary outcomes not collected.||||||
2579104|NCT02420210|Secondary|Progression Free Survival|Kaplan-Meier analysis will be performed. Prognostic factors that predict favorable outcomes and responses will be evaluated in both univariate and multivariate analyses using Cox proportional hazards regression for possible indicator of better PFS.|From date of study entry (date of first treatment) until progression, secondary malignancy, or death from any cause, assessed at 2 years|Funding for study was withdrawn after two patients were enrolled. Secondary outcomes not collected.||||||
2579105|NCT02420210|Secondary|Overall Survival (OS)|Survival analyses will be performed according to Kaplan and Meier methods. Prognostic factors that predict favorable outcomes and responses will be evaluated in both univariate and multivariate analyses using Cox proportional hazards regression for possible indicator of better OS. OS will also be stratified for bulky versus non-bulky disease comparisons (defined as any site with more than 5 cm in largest diameter).|From date of study entry (date of first treatment) until death from any cause, assessed at 3 years|Funding for study was withdrawn after two patients were enrolled. Secondary outcomes not collected.||||||
2579106|NCT02420210|Secondary|Overall Survival|Survival analyses will be performed according to Kaplan and Meier methods. Prognostic factors that predict favorable outcomes and responses will be evaluated in both univariate and multivariate analyses using Cox proportional hazards regression for possible indicator of better OS. OS will also be stratified for bulky versus non-bulky disease comparisons (defined as any site with more than 5 cm in largest diameter).|From date of study entry (date of first treatment) until death from any cause, assessed at 2 years|Funding for study was withdrawn after two patients were enrolled. Secondary outcomes not collected.||||||
2579107|NCT02420210|Secondary|Feasibility, Defined as Completing All Required Geriatric Assessments Where Applicable Per the Protocol in 80% or More of the Enrolled Eligible Patients||Up to 40 months|Funding for study was withdrawn after two patients were enrolled. Secondary outcomes not collected.||||||
2579108|NCT02420210|Primary|ORR (PR + CR) Using the Cheson et al Parameters|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 8 months||||Participants|||Count of Participants
2579109|NCT02420093|Primary|Change in Numeric Pain Rating Scale|"This questionnaire measures subjective perception of pain levels on a 0-10 (11 point) scale, with 0 being no pain and 10 being the worst pain imaginable."|Change from Baseline after 3 Weeks||||units on a scale||Standard Error|Mean
2579110|NCT02420093|Primary|Change in Fingertip to Floor Flexibility Test|This test measures subjects flexibility in forward trunk bending while subject is standing on a block 20 cm high. Measurement is in centimeters from fingertip to edge of step, above or below the step edge.|Baseline and 3 Weeks||||centimeters||Standard Error|Mean
2579111|NCT02420093|Primary|Change in Sorenson Test for Lumbar Muscle Endurance|This test measures a persons back strength in 1 repetition of holding a back posture in neutral as long as can while lying on their stomach, legs stabilized on a treatment table.|Baseline and 3 Weeks||||time in seconds||Standard Deviation|Mean
2579112|NCT02420093|Primary|Change in Left and Right Hamstring Length Testing|This test measures left and right hamstring length of the subject while they are lying on their back. The angle between the femur and tibia/fibula were measured when the hip angle held constant at 90 degrees and knee in full amount of available knee extension. This measure will use inclinometers for measurement.|Baseline and 3 Weeks||||degrees||Standard Error|Mean
2579113|NCT02420093|Primary|Change in Modified Oswestry Low Back Pain Disability Index|This questionnaire measures the impact subject's low back pain on functional tolerance levels. Scale range is 0-100 with the lower score indicating a higher functional / activity level as it relates to Low Back Pain.|Baseline and 3 Weeks||||units on a scale||Standard Error|Mean
2579114|NCT02420041|Secondary|Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5|"1= very dissatisfied to 5=very satisfied."|3 months post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.|||units on a scale of satisfaction||Full Range|Mean
2579115|NCT02420041|Secondary|Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5|"1= very dissatisfied to 5=very satisfied."|2 weeks post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.|||units on a scale of satisfaction||Full Range|Mean
2579116|NCT02420041|Secondary|Change in Pain Score Since SI Injection at 3 Months Post-procedure Using the DoD/VA PRS|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.Score reported is reporting a difference/change between two time points.|during/just before sacroiliac (SI) injection and 3 months post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.|||units on a scale||Full Range|Mean
2579117|NCT02420041|Secondary|Change in Pain Score Since Sacroiliac (SI) Injection at 2 Weeks Post-procedure Using the DoD/VA PRS|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome. Score reported is reporting a difference/change between two time points.|during/just before sacroiliac (SI) injection and 2 weeks post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.|||units on a scale||Full Range|Mean
2579118|NCT02420041|Secondary|Impression of Change of Condition at 3 Months Post-procedure Using the PGIC Scale|Study subjects rate their change in overall condition on a scale of 0-6 (0=no change, 6=better and a definite improvement that has made a real worthwhile difference). The range of the change in pain for both groups observed was in fact 0-5.|3 months post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.|||units on a scale||Full Range|Mean
2579119|NCT02420041|Secondary|Impression of Change of Condition at 2 Weeks Post-procedure Using the Patient Global Impression of Change (PGIC) Scale|Study subjects rate their change in overall condition on a scale of 0-6 (0=no change, 6=better and a definite improvement that has made a real worthwhile difference). The range of the change in pain for both groups observed was in fact 0-5.|2 weeks post-procedure|Numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study.|||units on a scale||Full Range|Mean
2579120|NCT02420041|Primary|Change in Pain Score From Baseline to 3 Months Post-procedure Using the DoD/VA PRS|Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.|3 months post-procedure minus baseline|numbers of participants analyzed are not consistent because study subjects were lost to follow-up along different points in time in the study|||units on a scale||Full Range|Mean
2579125|NCT02420015|Secondary|Number of Participants Who Report 7 Day Point Prevalence Abstinence|Secondary smoking outcomes will include 7-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 days.|6 months post-quit attempt (Session 6)||||Participants|||Count of Participants
2579126|NCT02420015|Secondary|Number of Participants Who Report 30 Day Point Prevalence Abstinence|Secondary smoking outcomes will include 30-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 30 days.|3 months post-quit attempt (Session 5)||||Participants|||Count of Participants
2579127|NCT02420015|Secondary|Number of Participants Who Report 7 Day Point Prevalence Abstinence|Secondary smoking outcomes will include 7-day point prevalence abstinence at each assessment, where abstinence is defined as no tobacco use in the prior 7 days.|3 months post-quit attempt (Session 5)||||Participants|||Count of Participants
2579128|NCT02420015|Primary|Number of Participants Whose Prolonged Abstinence is Bio-verified|Self-reported prolonged abstinence (primary outcome) will be verified by cotinine assay. Saliva samples will be collected from participants who self-report prolonged abstinence at each follow-up.|6 month follow-up||||Participants|||Count of Participants
2579129|NCT02420015|Primary|Number of Participants Who Self-report Prolonged Abstinence|Prolonged abstinence will exclude tobacco use in the first two weeks following the quit date, as is consistent with other smoking cessation trials.|6 month follow-up||||Participants|||Count of Participants
2579130|NCT02419937|Primary|Number of Participants With Major Adverse Cardiovascular Events (MACE)|30 day rate of major adverse cardiac events (MACE) following administration of Tocilizumab subcutaneously single dose within 24 hours of NSTEMI or STEMI as compared to administration of placebo|30 days after one time injection|Major Adverse Cardiac Events (MACE) for those gathered 30 days after receiving medication or placebo|||Participants|||Count of Participants
2579131|NCT02419755|Other Pre-specified|Minimal Residual Disease (MRD)|"MRD will be monitored until the completion of therapy (up to 500 days) for patients that do not go on to bone marrow transplant. If a patient goes on to receive a bone marrow transplant, at that point, they will no longer be monitored for minimal residual disease.~Concordance and associations of the MRD levels across three modalities (flow cytometry, PCR, and deep sequencing) as continuous measurements will be assessed by Pearson's and Spearman's correlations and Kendall's tau; MRD levels categorized into ordinal values will be analyzed by contingency tables with or without ordered margins."|Various time points until completion of therapy (up to 18 months)|Data was either not collected or is incomplete for each of the 10 participants, and therefore cannot be analyzed.||||||
2579132|NCT02419755|Other Pre-specified|Frequency of Identified Genomic Lesions|Frequencies of the identified lesions will be described by counts and proportions. An established method (Pounds et al., 2013) will be applied to identify genes and pathways frequently hit by the genomic lesions.|Once at enrollment|The investigator is unable to identify frequency of genomic lesions. To obtain useful information, a much larger sample size is needed. Genomic sequencing is cost-prohibitive to be performed on this small sample size where there are too few samples to obtain any useful information.||||||
2579133|NCT02419755|Secondary|Number of Relevant Toxicities Related to Therapy|"Events were graded using CTCAE v. 4.0. All toxicities will be monitored until the completion of therapy (up to 500 days) for patients that do not go on to bone marrow transplant. If a patient goes on to receive a bone marrow transplant, at that point, they will no longer be monitored for toxicity, as any further toxicities may be secondary to the transplant and not the study regimen.~This outcome reports those toxicities that are that were possibly, probably or definitely related to therapy. Participants were separately monitored for frequency of grade 5 events, grade 4 sepsis, grade 4 hemorrhage, and grade 4 hepatic toxicity across all patients in the stratum. Grade 4 and 5 events that are clearly and incontrovertibly due to extraneous causes or disease progression will be excluded. Higher grade events are considered more severe than lower grade."|From on-therapy date up to 18 months|Although only 3 Stratum 1 and 4 Stratum 2 participants completed the trial, there were 4 Stratum 1 participants and 6 Stratum 2 participants evaluable for this outcome measures.|||events|||Number
2579134|NCT02419755|Secondary|Number of Participants With 10-year Overall Survival|"All eligible patients who started the treatment will be included in this analysis. Patients later found ineligible will be replaced and excluded from the estimation. Death for any reason is considered as a failure.~Kaplan-Meier estimates of the OS and EFS functions will be computed, along with estimates of standard errors by the method of Peto. Three-year OS and EFS rates, as well as longer term survival rates (5 year and 10 year) will be estimated with 95% confidence intervals."|Ten years after the last enrollment|All eligible patients who started the treatment at the vorinostat maximum tolerated dose will be included in this analysis. The study was terminated before the maximum tolerated dose was determined.||||||
2579135|NCT02419755|Secondary|Number of Participants With 5-year Overall Survival|"All eligible patients who started the treatment will be included in this analysis. Patients later found ineligible will be replaced and excluded from the estimation. Death for any reason is considered as a failure.~Kaplan-Meier estimates of the OS and EFS functions will be computed, along with estimates of standard errors by the method of Peto. Three-year OS and EFS rates, as well as longer term survival rates (5 year and 10 year) will be estimated with 95% confidence intervals."|Five years after the last enrollment|All eligible patients who started the treatment at the vorinostat maximum tolerated dose will be included in this analysis. The study was terminated before the maximum tolerated dose was determined.||||||
2579136|NCT02419755|Secondary|Number of Participants With 3-year Overall Survival (OS)|"All eligible patients who started the treatment will be included in this analysis. Patients later found ineligible will be replaced and excluded from the estimation. Death for any reason is considered as a failure.~Kaplan-Meier estimates of the OS and EFS functions will be computed, along with estimates of standard errors by the method of Peto. Three-year OS and EFS rates, as well as longer term survival rates (5 year and 10 year) will be estimated with 95% confidence intervals."|Three years after the last enrollment|All eligible patients who started the treatment at the vorinostat maximum tolerated dose will be included in this analysis. The study was terminated before the maximum tolerated dose was determined.||||||
2579207|NCT02418546|Secondary|Change in Calorie Intake Over Time|Secondary aims include measuring the number of calories required to maintain or increase body weight in patients with neurodegenerative diseases. Total daily energy intake was calculated using 4 day food records at baseline, 3 months and 6 months|Change from baseline over 6 months|||||||
2579137|NCT02419755|Secondary|Number of Participant With 10-year Event Free Survival|"All eligible patients who started the treatment will be included in this analysis. Patients later found ineligible will be replaced and excluded from the estimation. In addition to death for any reason, no-response (i.e., other than CR, CRi, PR or PRi), off-treatment or off-study (except for the reason of being found ineligible), disease progression, relapse, and second malignancies will be considered as failures. The time to EFS will be set to 0 for patients who fail to respond.~Kaplan-Meier estimates of the OS and EFS functions will be computed, along with estimates of standard errors by the method of Peto. Three-year OS and EFS rates, as well as longer term survival rates (5 year and 10 year) will be estimated with 95% confidence intervals."|Ten years after the last enrollment|All eligible patients who started the treatment at the vorinostat maximum tolerated dose will be included in this analysis. The study was terminated before the maximum tolerated dose was determined.||||||
2579138|NCT02419755|Secondary|Number of Participants With 5- Year Event Free Survival|"All eligible patients who started the treatment will be included in this analysis. Patients later found ineligible will be replaced and excluded from the estimation. In addition to death for any reason, no-response (i.e., other than CR, CRi, PR or PRi), off-treatment or off-study (except for the reason of being found ineligible), disease progression, relapse, and second malignancies will be considered as failures. The time to EFS will be set to 0 for patients who fail to respond.~Kaplan-Meier estimates of the OS and EFS functions will be computed, along with estimates of standard errors by the method of Peto. Three-year OS and EFS rates, as well as longer term survival rates (5 year and 10 year) will be estimated with 95% confidence intervals."|Five years after the last enrollment|All eligible patients who started the treatment at the vorinostat maximum tolerated dose will be included in this analysis. The study was terminated before the maximum tolerated dose was determined.||||||
2579139|NCT02419755|Secondary|Number of Participants With 3 Year Event Free Survival (EFS)|"All eligible patients who started the treatment will be included in this analysis. Patients later found ineligible will be replaced and excluded from the estimation. In addition to death for any reason, no-response (i.e., other than CR, CRi, PR or PRi), off-treatment or off-study (except for the reason of being found ineligible), disease progression, relapse, and second malignancies will be considered as failures. The time to EFS will be set to 0 for patients who fail to respond.~Kaplan-Meier estimates of the OS and EFS functions will be computed, along with estimates of standard errors by the method of Peto. Three-year OS and EFS rates, as well as longer term survival rates (5 year and 10 year) will be estimated with 95% confidence intervals."|Three years after the last enrollment|All eligible patients who started the treatment at the vorinostat maximum tolerated dose will be included in this analysis. The study was terminated before the maximum tolerated dose was determined.||||||
2579140|NCT02419755|Primary|Overall Response Rate in All Participants|"For the purpose of the statistical analysis of the primary objective, response is assessed at the end of first treatment block at maximum tolerated dose of vorinostat (i.e., Induction Ia or Ib for myeloid and Induction for lymphoid and mixed lineage). Any eligible patient who starts first treatment block is considered evaluable. Response of CR, CRi, PR, or PRi is considered a success; otherwise a failure, which will include the cases of No-response, as well as off- treatment or off-study before response can be assessed, except cases found ineligible after enrollment. A patient found ineligible after enrollment will be taken off study and replaced by enrolling an additional MLLr patient.~The rate (probability) of response will be estimated by the sample proportion of patients who responded (CR, CRi, PR, PRi) to Induction, along with the 99% confidence interval and lower confidence bound. Three interim analyses will be performed to monitor the possible lack of efficacy."|End of first treatment block (up to 2 months)|The determination of overall response rate is contingent on the determination of the maximum tolerated dose. The study was terminated before the maximum tolerated dose was determined. Therefore, response rate cannot be calculated.||||||
2579141|NCT02419612|Secondary|Time-to-treatment Intensification (Addition of Insulin for Rescue Therapy or Discontinuation for Lack of Glycemic Control) During the 52-week Double-blind Treatment Period|To examine whether the time-to-treatment intensification with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment. The values presented are the percentage of subjects requiring the addition of insulin for rescue therapy or discontinuation for lack of glycemic control during the 52-week double-blind treatment period.|Up to 52 weeks of treatment|The randomized subject data set of all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period.|||% of participants|||Number
2579142|NCT02419612|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) at Week 52|To examine whether the change from baseline in SBP with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.|Baseline and 52 weeks of treatment|The randomized subject data set of all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period. Of these, only subjects with an evaluable baseline measurement for a given endpoint were analysed.|||mmHg||95% Confidence Interval|Least Squares Mean
2579143|NCT02419612|Secondary|Proportion of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%, at Week 52|To examine whether the proportion of subject achieving therapeutic glycemic response with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.|Up to 52 weeks of treatment|The randomized subject data set of all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period. Of these, only subjects with an evaluable baseline measurement for a given endpoint were analysed.|||% of participants||95% Confidence Interval|Number
2579144|NCT02419612|Secondary|Change From Baseline in Total Body Weight at Week 52|To examine whether the mean change from baseline in total body weight with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.|Baseline and 52 weeks of treatment|The randomized subject data set consisted of all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period. Of these, only subjects with an evaluable baseline measurement for a given endpoint were analysed.|||kg||95% Confidence Interval|Least Squares Mean
2579332|NCT02417376|Secondary|Change From Baseline in Lipid Profile at 3 Months|Change from baseline in lipid profile assessed at 3 months.|Baseline and 3 months||||mg/dl||Standard Deviation|Mean
2579145|NCT02419612|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 52|To examine whether the mean change from baseline in HbA1c with co-administered saxagliptin 5 mg and dapagliflozin 10 mg plus metformin is superior to titrated glimepiride plus metformin after 52 weeks of double-blind treatment.|Baseline and 52 weeks of treatment|The randomized subjects data set consisted of all randomized subjects who received at least 1 dose of study medication during the double-blind treatment period. Of these, only subjects with an evaluable baseline measurement for a given endpoint were analysed.|||% HbA1c||95% Confidence Interval|Least Squares Mean
2579146|NCT02419573|Secondary|Number of Patients With Favorable Neurologic Status on Hospital Discharge|"Number of patients with favorable neurologic status, defined as Modified Rankin Scale (MRS) <=3.~MRS values for neurologic outcome include:~0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead."|From enrollment through end of hospital course.|Neurologic status not known for 4 patients in the ETI group and 5 patients in LT group.|||Participants|||Count of Participants
2579147|NCT02419573|Secondary|Number of Patients Alive at Hospital Discharge|Number of patients alive at time hospital discharge.|From enrollment through end of hospital course. Maximum time interval not specified. Maximum time interval observed in study was 138 days.|Outcome for 1 patient in LT group not known.|||Participants|||Count of Participants
2579148|NCT02419573|Secondary|Return of Spontaneous Circulation (ROSC)|Presence of palpable pulses on Emergency Department arrival. Patients pronounced dead in the field coded as ROSC=[none].|Patients will be followed from the time of the CA until death or ROSC whichever occurs first. The time frame for this secondary outcome may vary from minutes to hours, but is not expected to last longer than 12 hours.||||Participants|||Count of Participants
2579149|NCT02419573|Primary|Number of Patients Alive at 72 Hours After Episode.|Number of patient alive at 72 hours after episode.|72 hours||||Participants|||Count of Participants
2579150|NCT02419547|Primary|Number of Participants Who Had Inducible Ventricular Tachycardia Under General Anesthesia.|Patients before induction of GA undergo noninvasive programmed stimulation (NIPS) using the patient's ICD. Subjects receive minimal versed/fentanyl during the NIPS. The anesthesiologist will decide whether to use propofol prior to the second induction, depending on the patient's cardiac function and hemodynamic status. After induction of GA with IV propofol, programmed stimulation will be performed from the RV catheter. Mapping under volatile agent will commence any time after twice the redistribution half-life of either agent has elapsed (propofol 4-16 mins) or have passed. Once the drug is out of the central compartment it is unlikely to affect myocardial electrolytes or ion channels. GA will be maintained with an inhalation agent, sevoflurane. A repeat programmed stimulation test will be performed. Endpoint for programmed stimulation will be induction of sustained monomorphic VT (SMVT).|While under General Anesthesia, an average of 6 hours|All participants who underwent general anesthesia and programed stimulation during VT ablation.|||participants|||Number
2579151|NCT02419521|Secondary|Cardiac Death and TVMI||8 Months||||Participants|||Count of Participants
2579152|NCT02419521|Secondary|Stent Thrombosis (ST)||8 Months||||Participants|||Count of Participants
2579153|NCT02419521|Secondary|Target Vessel Failure (TVF)||8 Months||||Participants|||Count of Participants
2579154|NCT02419521|Secondary|Target Lesion Failure (TLF)||8 Months||||Participants|||Count of Participants
2579155|NCT02419521|Secondary|Major Adverse Cardiac Event (MACE)|Defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods|8 Months||||Participants|||Count of Participants
2579156|NCT02419521|Secondary|Target Lesion Revascularization (TLR)||8 Months||||Participants|||Count of Participants
2579157|NCT02419521|Secondary|Target Vessel Myocardial Infarction (TVMI)||8 Months||||Participants|||Count of Participants
2579158|NCT02419521|Secondary|Cardiac Death||8 Months||||Participants|||Count of Participants
2579159|NCT02419521|Primary|In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography|In-stent late lumen loss at 8-months post-procedure as measured by quantitative coronary angiography|8 Months||||mm||Standard Deviation|Mean
2579160|NCT02419508|Secondary|Mean Percentage Change From Baseline at 09:00 at Week 6|IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 9:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits.A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.|Baseline, Week 6|FAS. Only subjects with a value at both baseline and time point are included in the calculation of change.|||percent change||Standard Deviation|Mean
2579161|NCT02419508|Secondary|Mean Change From Baseline in IOP at 09:00 at Week 6|IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 09:00 AM. Baseline is defined as the average of the 9:00 hour values at both Eligibility visits. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.|Baseline, Week 6|FAS. Only subjects with a value at both baseline and time point are included in the calculation of change.|||mmHg||Standard Deviation|Mean
2579162|NCT02419508|Secondary|Mean Percentage Change From Baseline in IOP at 11:00 at Week 6|IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.|Baseline, Week 6|FAS. Only subjects with a value at both baseline and time point are included in the calculation of change.|||percent change||Standard Deviation|Mean
2579163|NCT02419508|Secondary|Mean Change From Baseline in IOP at 11:00 at Week 6|IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry at 11:00 AM. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.|Baseline, Week 6|FAS. Only subjects with a value at both baseline and time point are included in the calculation of change.|||mmHg||Standard Deviation|Mean
2601687|NCT02150837|Secondary|Waist Circumference|Waist circumference expressed as an absolute from baseline.|4 weeks||||Inches||Standard Deviation|Mean
2579164|NCT02419508|Secondary|Mean Percentage Change From Baseline in Diurnal IOP at Week 6|IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.|Baseline, Week 6|FAS. Only subjects with a value at both baseline and time point are included in the calculation of change.|||percent change||Standard Deviation|Mean
2579165|NCT02419508|Secondary|Mean Diurnal IOP at Week 6|IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.|Week 6|FAS with data available|||mmHg||Standard Deviation|Mean
2579166|NCT02419508|Primary|Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6|IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.|Baseline, Week 6|FAS. Only subjects with a value at both baseline and time point are included in the calculation of change.|||mmHg||Standard Deviation|Mean
2579167|NCT02419469|Primary|Event Free Survival (EFS)|Event free survival defined as the time from treatment to relapse of leukemia or death for any reason or lost to follow-up. Study regimen considered successful if it exhibits a 3-year EFS rate greater than 65% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%.|3 years||||Participants|||Count of Participants
2579168|NCT02419313|Secondary|Patients With Significant Improvement in Unified Parkinsons Disease Rating Tremor Scale|This scale measures the amplitude of the tremor. For instance tremor of more than 4cm oscillation is grade 4. UPDRS tremor scale is 0-4 , 4 being severe tremor. Significant improvement for this protocol considered two grades of improvement .|4 Weeks||||participants|||Number
2579169|NCT02419313|Secondary|Number of Patients Whose Patient Global Impression of Change (PGIC) Improved|"The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:~No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved~This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment."|4 weeks||||participants|||Number
2579170|NCT02419313|Primary|Unified Parkinsons Disease Rating Scale (UPDRS) Tremor Scale|The primary outcome measure in this protocol is significant improvement of tremor (equal or over 2 grade improvement) of the Unified Parkinson's Disease Rating Scale 4 weeks after Xeomin injection. The score is 0 to 4 , ) being no tremor and 4 severe tremor. The higher the score, the more severe the tremor.|4 weeks||||participants|||Number
2579171|NCT02419001|Primary|Ceftriaxone PK Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUCt) With (Period 2) and Without (Period 1) SYN-004.||2 weeks||||h*ng/mL||Standard Deviation|Mean
2579172|NCT02419001|Primary|Ceftriaxone PK Time to Reach Cmax (Tmax) With (Period 2) and Without (Period 1) SYN-004.|Samples were collected at 0.25 h, 0.5 through 2 h, and 3 through 7 h after the infusion start. Standard deviations may be 0 if all collected T max values occur at the same time.|2 weeks||||hours||Standard Deviation|Mean
2579173|NCT02419001|Primary|Ceftriaxone PK Maximum Observed Plasma Concentration (Cmax) With (Period 2) and Without (Period 1) SYN-004.||2 weeks||||ng/mL||Standard Deviation|Mean
2579174|NCT02418910|Primary|Comparison of Two Brief Assessment Measures: KIOS Bipolar or eMOODs|measure is the count of participants with KIOS or eMOOD assessments completed on time, completed only with follow-up prompts, and the number of weeks not submitted.|52 weeks||||Participants|||Count of Participants
2579175|NCT02418819|Secondary|Plasma Concentrations of PF-06663872 at for Each Dose.|PF-06412562 plasma concentration for each dose at times 6 and 12 hours on Days 1, 7 and 12, as well as 0 hours on Day 16.|6 and 12 hours on Days 1, 7 and 12, as well as 0 hours on Day16|The PK concentration analysis set was defined as all participants randomized and treated who had at least 1 PK concentration. Here, “number analyzed” signifies the participants evaluable for each time points.|||ng/mL||Standard Deviation|Mean
2579176|NCT02418819|Secondary|Plasma Concentrations of PF-06412562 for Each Dose.|PF-06412562 plasma concentration for each dose at 6 and 12 hours on Days 1, 7 and 12, as well as 0 hours on Day 16.|6, and 12 hours on Days 1, 7 and 12, as well as 0 hours on Day 16|The PK concentration analysis set was defined as all participants randomized and treated who had at least 1 PK concentration. Here, “number analyzed” signifies the participants evaluable for each time points.|||ng/mL||Standard Deviation|Mean
2579177|NCT02418819|Primary|Change From Baseline in Blood Oxygen Level Dependent (BOLD) fMRI Activation Parameter Estimates (Z-scores) in Anterior Ventral Striatum Region of Interest (ROI) for the Contrast of Cue Gain > Cue No Gain in Monetary Incentive Delay (MID) Task on Day 15|MRI parameter estimates refer to the 90th percentile Z-statistics across all voxels within the Region of Interest (ROI). This task provided a measure of reward anticipation and reward consummation. One of 3 shapes was presented on the screen (each uniquely associated with gain, loss and neutral) as a cue, and participants were instructed to respond to each cue, using their dominant hand, by pressing in response to a subsequent target that appeared for a variable length of time. Baseline was defined as Day 0 assessment. To be included in analysis participants must have complete Monetary Incentive Delay (MID) data at both Baseline and post-baseline, without excessive head motion. Participants with MID <40% at baseline were excluded from the analysis and summary statistics. Scores were not bounded by a minimum or maximum range, higher z-score implies a greater motivation of the participant by the prospect of monetary gain than no monetary gain.|Baseline, Day 15|PPAS was used,defined as subset of FAS dataset.Criteria for PPAS:1)Received all doses of study treatment to which they were randomized;2)No major protocol deviation;3)Had a baseline measurement and at least 1 post baseline measurement for at least 1 PD endpoint.Overall Number of Participants Analyzed=participants evaluable in this outcome measure.|||Z scores||Standard Deviation|Mean
2605529|NCT02108223|Secondary|Number of Mature Oocyte|median number of mature oocytes retrieved per participant|up to 9 month||||oocytes||Standard Deviation|Median
2579178|NCT02418819|Primary|Change From Baseline to Day 13 of Wechsler Memory Scale (WMS III) Spatial Span + Letter Number Span Composite Score (Working Memory Domain)|MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess working memory of participants. Total score range of this subset ranges from 40 (minimum score) to 60 (maximum score), with higher scores indicating better cognitive function.|Baseline, Day 13|Per Protocol Analysis Set (PPAS)subset of Full Analysis Set(FAS).Criteria:1)Received all doses of study treatment to which they randomized2)No major protocol deviation3)Had baseline measurement and at least 1 post baseline measurement for at least 1 PD endpoint.Overall Number of Participants Analyzed=participants evaluable in this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2579179|NCT02418819|Primary|Number of Participants With New Onset and Worsening of Post Baseline Suicidality in Columbia Suicide Severity Rating Scale (C‑SSRS) on Day 1, Day 7 and Follow-up.|The C-SSRS was an interview based rating scale to systematically assess suicidal ideation and suicidal behavior. Versions were available for Screening/Baseline and follow-up visits. Post-baseline suicidality was displayed without regard to baseline and as new onset or worsening relative to baseline. A participant was considered to have a new onset of suicidality if the participant reported no ideation and no behavior at the baseline assessment. A participant was considered to have a worsening of suicidality if the participant moved to a lower numbered Columbia Classification Algorithm of Suicide Assessment (C-CASA) category (observed in categories 1-4) than was reported at baseline.|Baseline, Days 1,7 and follow-up (7-10 days after last dose of study drug, up to 26 days)|The safety analysis set was used, defined as all participants who received at least 1 dose of study medication|||Participants|||Count of Participants
2579180|NCT02418819|Primary|Number of Participants With Blood and Urine Safety Laboratory Test Abnormalities|The total number of participants with blood and urine laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis, and some other tests.|Baseline up to Day 15|"The safety analysis set was used, defined as all participants who received at least 1 dose of study medication. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2579181|NCT02418819|Primary|Number of Participants With Electrocardiogram (ECG) (Standard 12‑Lead) Data Meeting Categorical Summarization Criteria|ECG categorical summarization criteria were 1), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval): more than or equal to (>=) 200 milliseconds (msec); for percent change(PChg), >=25 percent (%) increase when baseline (b)>100 msec; or increase >=50% when b less than or equal to (<=)100 msec; 2), the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=300 msec; >=25percent (%) increase when b >200 msec; or increase >=50% when b <=200 msec; 3), time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec and >=500 msec; increase from b >=30 - <60 and >=60 msec|Baseline up to 7-10 days after last dose of study drug, up to 26 days|The safety analysis set was used, defined as all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2579182|NCT02418819|Primary|Number of Participants With Supine and Standing Vital Signs Meeting Categorical Summarization Criteria|Vital Signs tests included systolic and diastolic blood pressure (BP) and pulse rate of seated supine and standing . Vital signs categorical summarization criteria were 1), supine and standing BP: systolic (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from baseline, diastolic <50 mm Hg; 2), supine and standing pulse rate <40 or greater than (>) 120 beats per minute (bpm).|Baseline up to 7-10 days after last dose of study drug, up to 26 days|The safety analysis set was used, which defined as all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2579183|NCT02418819|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. AEs included both serious and non-serious AEs.|Baseline up to 7-10 days after last dose of study drug, up to 26 days|The safety analysis set was used, defined as all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2579184|NCT02418676|Secondary|Blood Glucose Tests in Order to Assess Whether the Gel With Hydroxypropyl-beta-cyclodextrin Complexed With Insulin (HPβCD-I) or With Insulin Could Cause an Increase in the Rate of Insulin in the Blood of Patients|Dosages were provided four times daily (04h, 10h, 16h and 22h) to each patient during the 15-day study period, giving a total of 60 doses. To obtain these dosages, a drop of blood of patients was placed on a colorimetric strip and blood glucose was measured with the use of an Accu Check Active® glucose meter. The mean of 60 dosages was calculated for each patient at the end of 15 days. For each group assessed, it was calculated the mean of the measurements of the five patients, resulting in a single value.|Assessed daily at 04 h, 10 h, 16 h and 22 h for 15 days|Brazilian, bedridden, of both genders, aged between 45 and 75 years old and diabetic or not. Hyperglycemic volunteers and those with pressure ulcers other than grade II were excluded from the study.|||mg/dL||95% Confidence Interval|Mean
2579208|NCT02418546|Primary|Estimated Mean Change in Weight From Baseline to 6 Months|The Primary Aim is to study the feasibility and efficacy to maintain or increase body weight of an e-Health application and in-person nutritional counseling compared to standard of care and to each other. Weights were measured in the clinic every 3 months.|Change over time from Baseline to 6 months|"Please note that these are Parameter Estimates rather than means"|||kg||95% Confidence Interval|Mean
2579333|NCT02417376|Secondary|Change From Baseline in Lipid Profile at 1 Month|Change from baseline in lipid profile assessed at 1 month.|Baseline and 1 month||||mg/dl||Standard Deviation|Mean
2579185|NCT02418676|Primary|Efficacy Index (%EI)|Every three days the pressure ulcers (PUs) of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos were evaluated for measurement of PUs and any kind of irritation. At the end of this stage, the properly gathered study data was interpreted using the analysis software Mobile Wound Analyzer® (MOWA). Healing efficacy indices (% EI) were calculated as percentage reduction in the wound size at days 3, 6, 9, 12 and 15 from treatment beginning (d0). The % EI of the wound size was calculated by the following equation: %EI= ((Vsp.day-Vi)/Vi))x100. Vsp.day refers to the diameter (mm) values measured at day 3, 6, 9,12 and 15, while Vi refers to the baseline value measured before treatment (d0). The most representative result of treatment efficacy was observed on day 15, therefore it was used to calculate the % EI. For each group assessed, it was calculated the mean % EI of the five patients, resulting in a single value.|Measured every 3 days for 15 days|Brazilian, bedridden, of both genders, aged between 45 and 75 years old and diabetic or not. Hyperglycemic volunteers and those with pressure ulcers other than grade II were excluded from the study. Grade II pressure ulcers were selected as they are a superficial lesion, with little tissue loss, and allow easy visualization of healing.|||percentage (%)||95% Confidence Interval|Mean
2579186|NCT02418585|Secondary|Change From Baseline in EQ 5D-5L- Sum Score to End of Double-blind Induction Phase (Day 28)|"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). Health Status Index range is -0.148 - 0.949, is anchored at 0 (dead) and 1 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state."|Baseline up to End of Double-blind Induction Phase (Day 28)|FAS is defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2579187|NCT02418585|Secondary|Change From Baseline in EQ 5D-5L- European Quality of Life - Visual Analogue Scale (EQ-VAS) to End of Double-blind Induction Phase (Day 28)|EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine).|Baseline up to End of Double-blind Induction Phase (Day 28)|FAS is defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double blind induction phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2579188|NCT02418585|Secondary|Change From Baseline in EQ 5D-5L-Health Status Index to End of Double-blind Induction Phase (Day 28)|"European Quality of Life Group-5 Dimension-5-Level (EQ-5D-5L) is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). Health Status Index range is -0.148 - 0.949, is anchored at 0 (dead) and 1 (full health)."|Baseline up to End of Double-blind Induction Phase (Day 28)|FAS is defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a Scale||Standard Deviation|Mean
2579189|NCT02418585|Secondary|Change From Baseline in Generalized Anxiety Disorder (GAD-7) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])|"GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21). The last post baseline observation during the phase was carried forward as End Point for that phase."|Baseline up to Endpoint (Double-blind Induction Phase [Day 28])|FAS is defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2579190|NCT02418585|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])|"CGI-S provides measure of severity of participant's illness including participant's history, psychosocial circumstances, symptoms, behavior and impact of symptoms on ability to function. CGI-S evaluates severity of psychopathology on scale of 0 to 7. Considering total clinical experience, participant is assessed on severity of mental illness according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients. CGI-S permits global evaluation of participant's condition at given time. The last post baseline observation during the phase was carried forward as End Point for that phase."|Baseline up to Endpoint (Double-blind Induction Phase [Day 28])|FAS defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Full Range|Median
2579191|NCT02418585|Secondary|Percentage of Participants in Remission (SDS Total Score <=6 and Individual Item Scores Each <=2) at the End of 4-Week Double-blind Induction Phase (Day 28)|Remission defined as SDS total score <= 6 and individual item scores each <= 2. SDS is a participant reported outcome measure and is a 5-item questionnaire which has been widely used and accepted for assessment of functional impairment and associated disability. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items were summed to create a total score of 0-30 where a higher score indicates greater impairment. It also has one item on days lost from school or work and one item on days when under productive.|At Day 28 (End of Double-blind Induction Phase)|FAS is defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
2579192|NCT02418585|Secondary|Percentage of Participants in Response (SDS Total Score <=12 and Individual Item Scores Each <=4) at the End of 4-Week Double-blind Induction Phase (Day 28)|Response defined as SDS total score <= 12 and individual item scores each <= 4. SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. First three items assess disruption of 1 work/school, 2 social life, 3 family life/home responsibilities using a 0(no impairment)-10 (most severe impairment). Score for first 3 items are summed to create total score of 0-30 where higher score indicates greater impairment and a negative change in score indicates improvement. It also has one item on days lost from school or work and one item on days when under productive.|At Day 28 [end of Double-blind Induction Phase]|FAS is defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
2579193|NCT02418585|Secondary|Percentage of Participants in Remission (MADRS<=12) at the Endpoint (Double-blind Induction Phase [Day 28])|"Remission was defined as participants who had a MADRS total score of less than or equal to (=<) 12. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. The last post baseline observation during the phase was carried forward as End Point for that phase."|At Endpoint (Double-blind Induction Phase [Day 28])|FAS is defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
2579194|NCT02418585|Secondary|Percentage of Participants Who Achieved >=50% Reduction From Baseline in MADRS Total Score at the Endpoint (Double-blind Induction Phase [Day 28])|"MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. The percentage of participants with greater than or equal to (>=) 50 % reduction from baseline in MADRS total score was reported. The last post baseline observation during the phase was carried forward as End Point for that phase."|At Endpoint (Double-blind Induction Phase [Day 28])|FAS is defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
2579195|NCT02418585|Secondary|Change From Baseline in Patient Health Questionnaire - 9-Item Depression Module (PHQ-9) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis|"PHQ-9 is 9-item, self-report scale assessing depressive symptoms. Each item is rated on 4-point scale (0=Not at all, 1=Several Days, 2=More than half days, 3=Nearly every day). Scale scores each of 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders, Major Depressive Disorder criteria and it has been used both as screening tool and measure of response to treatment for depression. The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. Severity of PHQ-9 categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27). The last post baseline observation during the phase was carried forward as End Point for that phase."|Baseline up to Endpoint (Double-blind Induction Phase [Day 28])|FAS is defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during double-blind induction phase. Here 'N' signifies overall number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2579196|NCT02418585|Secondary|Change From Baseline in Patient Health Questionnaire - 9-Item Depression Module (PHQ-9) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis|PHQ-9 is 9-item, self-report scale assessing depressive symptoms. Each item is rated on 4-point scale (0=Not at all, 1=Several Days, 2=More than half days, 3=Nearly every day. Scale scores each of 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders, Major Depressive Disorder criteria and it has been used both as screening tool and measure of response to treatment for depression. The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. Severity of PHQ-9 categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27).|Baseline up to Day 28 of Double-blind Induction phase|FAS is defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during double-blind induction phase. Here 'N' signifies overall number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2579197|NCT02418585|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis|"The SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. First three items assess disruption of 1 work/school, 2 social life, 3 family life/home responsibilities using a 0(no impairment)-10 (most severe impairment). Score for first 3 items are summed to create total score of 0-30 where higher score indicates greater impairment and a negative change in score indicates improvement. It also has one item on days lost from school or work and one item on days when under productive. The last post baseline observation during the phase was carried forward as End Point for that phase."|Baseline up to Endpoint (Double-blind Induction Phase [Day 28])|FAS is defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during double-blind induction phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2579198|NCT02418585|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis|The SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. First three items assess disruption of 1 work/school, 2 social life, 3 family life/home responsibilities using a 0(no impairment)-10 (most severe impairment). Score for first 3 items are summed to create total score of 0-30 where higher score indicates greater impairment and a negative change in score indicates improvement. It also has one item on days lost from school or work and one item on days when under productive.|Baseline up to Day 28 of Double-blind Induction phase|FAS is defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during double-blind induction phase. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2579199|NCT02418585|Secondary|Percentage of Participants With Onset of Clinical Response on Day 2 and Day 8|A participant was defined as having a clinical response if there is at least 50 percent (%) improvement from baseline in the MADRS total score with onset by Day 2 and Day 8 that was maintained to Day 28. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Participants who did not meet such criterion or discontinue during the study before Day 28 for any reason were considered as non-responders.|Day 2 up to Day 28 and Day 8 up to Day 28|FAS is defined as all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase.|||Percentage of participants|||Number
2579200|NCT02418585|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- Analysis of Covariance (ANCOVA) Analysis|"MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. The last post baseline observation during the phase was carried forward as End Point for that phase."|Baseline up to Endpoint (Double-blind Induction Phase [Day 28])|FAS defined as all randomized participants who received at least 1 dose of intranasal study medication, 1 dose of AD medication during double-blind induction phase (D-BIP). Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2579201|NCT02418585|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 in the Double-blind Induction Phase- Mixed-Effects Model Using Repeated Measures (MMRM) Analysis|MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.|Baseline up to Day 28 of Double-blind Induction Phase|Full analysis set (FAS) defined as all randomized participants who received at least 1 dose of intranasal study medication, 1 dose of oral antidepressant (AD) medication during double-blind induction phase (D-BIP). Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2579202|NCT02418546|Other Pre-specified|Exploratory Efficacy Measure: Quality of Life|Quality of life will be measured using the PROMIS SF 1.1 in units.|18 months|||||||
2579203|NCT02418546|Other Pre-specified|Exploratory Efficacy Measure: Disease Progression in ALS Functional Rating Scale-Revised (ALSFRS-R)|Disease progression will be measured using disease-specific outcome measures (the ALSFRS-R scale). The range of the ALSFRS-R is 0-40 with higher scores indicating better function. Change in ALSFRS-R is reported as units/month.|Change over time from Baseline to 6 months|Change over time of continuous, longitudinal measures was analyzed using a shared-baseline, mixed effect model with fixed effects for visit and an interaction between post-baseline visit and study arm and with a random slope and intercept for each subject with unstructured covariance.|||units per month||95% Confidence Interval|Mean
2579204|NCT02418546|Other Pre-specified|Exploratory Efficacy Measure: Survival|Vital status will be measured until the last subject last visit.|baseline to 18 months|||||||
2579205|NCT02418546|Secondary|Tolerability: The Number of Participants Who Complete the Study While Complying With at Least 80% of the Counseling Sessions||Baseline, 3 months and 6 months|||||||
2579206|NCT02418546|Secondary|Safety: Frequency of Adverse Events|To study the safety of an e-Health application and in-person nutritional counseling compared to standard of care and to each other.|From baseline to month 7 (one month after 6 month end of study visit)|||||||
2579209|NCT02418468|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks|To compare the effects of indacaterol 150ug once dialy (od) to placebo in GOLD 2014 Group B COPD patients, in terms of 24-hour postdose (trough) forced expiratory volume in 1 second (FEV1) after 12 weeks of dosing.|at week 12|Full Analysis Set (FAS) - would include all randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients would be analyzed according to the treatment assigned at randomization.|||Liters||Standard Error|Least Squares Mean
2579210|NCT02418455|Secondary|Change From Baseline Over Time in Spleen Measurement|For all participants (including the participant previously treated with UX003 under an eIND), the last non-missing study assessment prior to the first dose in this study was used as baseline.|Baseline, Weeks 12, 24, 48, 96, 144|Full analysis set: all enrolled participants who received at least one dose of UX003 during the study with a non-missing assessment at baseline and given time point.|||cm||Standard Deviation|Mean
2579211|NCT02418455|Secondary|Change From Baseline Over Time in Liver Measurement|For all participants (including the participant previously treated with UX003 under an eIND), the last non-missing study assessment prior to the first dose in this study was used as baseline.|Baseline, Weeks 12, 24, 48, 96, 144|Full analysis set: all enrolled participants who received at least one dose of UX003 during the study with a non-missing assessment at baseline and given time point.|||cm||Standard Deviation|Mean
2579212|NCT02418455|Secondary|Change From Pre-Treatment (Within 2 Years) to Post-Treatment Growth Velocity Z-Score|"The Z-score indicates the number of standard deviations away from a reference population (based on Tanner's standard [Tanner et al. 1985]) in the same age range and with the same sex. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome.~The growth velocity for pre-treatment is based on standing height within 2 years prior to treatment. The growth velocity for post-treatment is based on all standing height data during the study period. For the participant previously treated with UX003 under an eIND, the growth velocity was calculated for pre initial UX003 treatment and post initial UX003 treatment."|Pre-treatment (based on standing height within 2 years prior to treatment), Post-treatment (based on all standing height data during the study period up to Week 48)|Full analysis set: all enrolled participants who received at least one dose of UX003 during the study with both historical pre-treatment (within 2 years) and post-treatment data. Growth velocity Z-score was only calculated for participants ≥ 2.25 years.|||Z-score||Standard Deviation|Mean
2579213|NCT02418455|Secondary|Post-UX003 Growth Velocity (cm/yr) for Participants With Both Historical Pre-UX003 (Within 2 Years) and Post-UX003 Data|The growth velocity for pre-treatment is based on standing height within 2 years prior to treatment. The growth velocity for post-treatment is based on all standing height data during the study period. For the participant previously treated with UX003 under an eIND, the growth velocity was calculated for pre initial UX003 treatment and post initial UX003 treatment.|Pre-treatment (based on standing height within 2 years prior to treatment), Post-treatment (based on all standing height data during the study period up to 240 weeks)|Full analysis set: all enrolled participants who received at least one dose of UX003 during the study with both historical pre-treatment (within 2 years) and post-treatment data.|||cm/year||Standard Deviation|Mean
2579214|NCT02418455|Secondary|Change From Baseline Over Time in Weight|For all participants (including the participant previously treated with UX003 under an eIND), the last non-missing study assessment prior to the first dose in this study was used as baseline.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132|Full analysis set: all enrolled participants who received at least one dose of UX003 during the study with a non-missing assessment at baseline and given time point.|||kg||Standard Deviation|Mean
2579215|NCT02418455|Secondary|Change From Baseline Over Time in Head Circumference Z-Score|"The Z-score indicates the number of standard deviations away from a reference population (from the CDC growth charts) in the same age range and with the same sex. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome.~For all participants (including the participant previously treated with UX003 under an eIND), the last non-missing study assessment prior to the first dose in this study was used as baseline."|Baseline, Weeks 12, 24, 36, 48|Full analysis set: all enrolled participants who received at least one dose of UX003 during the study with a non-missing assessment at baseline and given time point.|||Z-score||Standard Deviation|Mean
2579216|NCT02418455|Secondary|Change From Baseline Over Time in Head Circumference|For all participants (including the participant previously treated with UX003 under an eIND), the last non-missing study assessment prior to the first dose in this study was used as baseline.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132|Full analysis set: all enrolled participants who received at least one dose of UX003 during the study with a non-missing assessment at baseline and given time point.|||cm||Standard Deviation|Mean
2579217|NCT02418455|Secondary|Change From Baseline Over Time in Standing Height Z-Score|"The Z-score indicates the number of standard deviations away from a reference population (from the CDC growth charts) in the same age range and with the same sex. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome.~For all participants (including the participant previously treated with UX003 under an eIND), the last non-missing study assessment prior to the first dose in this study was used as baseline."|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132|Full analysis set: all enrolled participants who received at least one dose of UX003 during the study with a non-missing assessment at baseline and given time point.|||Z-score||Standard Deviation|Mean
2579218|NCT02418455|Secondary|Change From Baseline Over Time in Standing Height|For all participants (including the participant previously treated with UX003 under an eIND), the last non-missing study assessment prior to the first dose in this study was used as baseline.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132|Full analysis set: all enrolled participants who received at least one dose of UX003 during the study with a non-missing assessment at baseline and given time point.|||cm||Standard Deviation|Mean
2579238|NCT02418026|Secondary|Score at Numeric Pain Rating Scale|The numeric pain rating scale range from 0 (no pain) to 10 (worst pain imaginable)|day 3||||units on a scale||Standard Deviation|Mean
2579239|NCT02418026|Secondary|Score at Numeric Pain Rating Scale|The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)|day 1||||units on a scale||Standard Deviation|Mean
2579219|NCT02418455|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuations Due to TEAEs|Adverse event (AE): any untoward medical occurrence in a participant, whether or not considered drug related. Serious AE (SAE): an AE or suspected adverse reaction that at any dose results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect. Other important medical events may also, in the opinion of the Investigator, be considered SAEs. An AE was considered a TEAE if it occurred on or after the first dose, and was not present prior to the first dose, or it was present at the first dose but increased in severity during the study. Events recorded as either possibly, probably, or definitely related to treatment were categorized as related. AE severity was graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.03.|From first dose of study drug until 30 days after the last dose of study drug. Mean (SD) treatment duration was 98.11 (29.02) weeks|Full analysis set: all enrolled participants who received at least one dose of UX003 during the study.|||Participants|||Count of Participants
2579220|NCT02418455|Primary|Percent Change From Baseline in uGAG Excretion (LC-MS/MS-DS) at Week 48|Liquid chromatography-mass spectrometry/mass spectrometry-dermatan sulfate (LS-MS/MS-DS) method. For the participant previously treated with UX003 under an eIND, percent change from initial baseline was used.|Baseline (Week 0), Week 48|Full analysis set: all enrolled participants who received at least one dose of UX003 during the study and had a non-missing baseline and Week 48 assessment.|||percent change||Standard Deviation|Mean
2579221|NCT02418312|Primary|Number of Participants With Healed Peptic Ulcer|Follow-up endoscopy was performed at the end of the 6th month|6 months|Intention to treat|||participants|||Number
2579222|NCT02418234|Secondary|Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure|The investigators will employ Analysis of Variance (ANOVA) method to analyze the differences of T790M mutation by ddPCR in patients among the different Clinical modes of TKI failure.|up to 2 years||||percentage of total ctDNA||Full Range|Median
2579223|NCT02418234|Secondary|Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure|The investigators will describe the number of participants with T790M mutation in each different clinical mode of TKI failure by ARMS and ddPCR, and employ chi-square test to analyze the distribution of T790M mutation by ARMS and ddPCR in patients among the different Clinical modes of TKI failure.|up to 2 years||||participants|||Number
2579224|NCT02418234|Primary|Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient|The investigators will describe the abundance of T790M mutation on ctDNA detected by ddPCR assay in patients with NSCLC resistant to TKIs.|up to 2 years||||percentage of total ctDNA||Full Range|Median
2579225|NCT02418234|Primary|Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay|The investigators will describe the number of T790M mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC) resistant to tyrosine kinase inhibitors (TKIs).|up to 2 years||||participants|||Number
2579226|NCT02418182|Secondary|Number of Participants With Use of Analgesics in the First 24 Hours After Discharge|Number of participants with use of analgesic medications in the first 24 hours after discharge from procedure|60-minutes post-procedure to 24-hours after procedure|Of 99 patients enrolled, 72 required re-consent. Of these, 39 re-consented and 33 could not be re-consented. Therefore, these 33 were excluded, leaving 66 patients for analysis. Two of these were lost to follow-up and were excluded, leaving 64 women (31 control, 33 active arm) in the final analysis.|||Participants|||Count of Participants
2579227|NCT02418182|Secondary|Number of Participants With Use of Analgesics up to 60 Minutes Post Procedure|Number of participants requiring use of analgesic medications in the post-operative recovery suite|60-minutes post-procedure|Of 99 patients enrolled, 72 required re-consent. Of these, 39 re-consented and 33 could not be re-consented. Therefore, these 33 were excluded, leaving 66 patients for analysis. Two of these were lost to follow-up and were excluded, leaving 64 women (31 control, 33 active arm) in the final analysis.|||Participants|||Count of Participants
2579228|NCT02418182|Primary|Median of Cumulative Pain Scores Up to 24 Hours Post Procedure|Median Pain score (measured on a visual analog scale from 0-10 where 0=no pain and 10=worst pain) taken at 24-hours post-procedure|24-hours post-procedure|Of 99 patients enrolled, 72 required re-consent. Of these, 39 re-consented and 33 could not be re-consented. Therefore, these 33 were excluded, leaving 66 patients for analysis. Two of these were lost to follow-up and were excluded, leaving 64 women (31 control, 33 active arm) in the final analysis.|||score on a scale||Inter-Quartile Range|Median
2579229|NCT02418182|Primary|Median of Cumulative Pain Scores Up to 60 Minutes Post Procedure|Median of cumulative pain scores (measured on a visual analog scale from 0-10 where 0=no pain and 10=worst pain) taken during the recovery period (15, 30, 45, and 60 minutes post procedure)|60 minutes post-procedure|Of 99 patients enrolled, 72 required re-consent. Of these, 39 re-consented and 33 could not be re-consented. Therefore, these 33 were excluded, leaving 66 patients for analysis. Two of these were lost to follow-up and were excluded, leaving 64 women (31 control, 33 active arm) in the final analysis.|||score on a scale||Inter-Quartile Range|Median
2579230|NCT02418156|Primary|Device-Related Adverse Events|Proportion of patients experiencing device related adverse events.|Up to 12 months follow-up|Several participants had both limbs treated resulting in a greater number of procedures than participants analyzed.|||Proportion of Participants that Experien|Procedures|95% Confidence Interval|Number
2579231|NCT02418026|Secondary|Non-steroidal Anti-inflammatory Drug Intake||day 3||||participants|||Number
2579232|NCT02418026|Secondary|Mean Pulse||for 2 hours in the recovery room at regular intervals (average)||||bpm||Standard Deviation|Mean
2579233|NCT02418026|Secondary|Mean Pulse||during surgery (average), up to 2 hours||||bpm||Standard Deviation|Mean
2579234|NCT02418026|Secondary|Mean Pulse||preoperative, up to 2 hours||||bpm||Standard Deviation|Mean
2579235|NCT02418026|Secondary|Mean Blood Pressure||for 2 hours in the recovery room at regular intervals (average)||||mm Hg||Standard Deviation|Mean
2579236|NCT02418026|Secondary|Mean Blood Pressure||during surgery (average), up to 2 hours||||mm Hg||Standard Deviation|Mean
2579237|NCT02418026|Secondary|Mean Blood Pressure||preoperative, up to 2 hours||||mm Hg||Standard Deviation|Mean
2579244|NCT02418000|Secondary|Number of Participants With Suppression of pFLT3 by PIA at 24 Hours Post-dose|Blood assay: Plasma inhibitory assay (PIA) measuring pFLT3 in blood at 24 hours post-dose|Cycle 1 Day 1, 24 hours post-dose.|All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative.|||Participants|||Count of Participants
2579245|NCT02418000|Secondary|Number of Participants With Suppression of pFLT3 by PIA at 4 Hours Post-dose|Blood assay: Plasma inhibitory assay (PIA) measuring pFLT3 in blood at 4 hours post-dose|Cycle 1 Day 1, 4 hours post-dose.|All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative.|||Participants|||Count of Participants
2579246|NCT02418000|Secondary|Number of Participants With Suppression of in pERK by PIA 24 Hours Post-dose|Blood assay: Plasma inhibitory assay (PIA) measuring pERK in blood at 24 hours post-dose|Cycle 1 Day 1, 24 hours post-dose.|All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative.|||Participants|||Count of Participants
2579247|NCT02418000|Secondary|Number of Participants With Suppression of pERK by PIA at 4 Hours Post-dose|Blood assay: Plasma inhibitory assay (PIA) measuring pERK in blood at 4 hours post-dose|Cycle 1 Day 1, 4 hours post-dose.|All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative.|||Participants|||Count of Participants
2579248|NCT02418000|Secondary|Number of Participants With Suppression of pAKT at 24 Hours Post-dose|phospho-AKT (pAKT) in blood assessed by Western blot at 24 hours post-dose|Cycle 1 Day 1, 24 hours post-dose.|All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative.|||Participants|||Count of Participants
2579249|NCT02418000|Secondary|Number of Participants With Suppression of pAKT at 4 Hours Post-dose|phospho-AKT (pAKT) in blood assessed by Western blot at 4 hours post-dose|Cycle 1 Day 1, 4 hours post-dose.|All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative.|||Participants|||Count of Participants
2579250|NCT02418000|Secondary|Number of Participants With Suppression of pFLT3 at 24 Hours Post-dose|phospho-FLT3 (pFLT3) in blood assessed by Western blot at 24 hours post-dose|Cycle 1 Day 1, 24 hours post-dose.|All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative.|||Participants|||Count of Participants
2579251|NCT02418000|Secondary|Number of Participants With Suppression of pFLT3 at 4 Hours Post-dose|phospho-FLT3 (pFLT3) in blood assessed by Western blot at 4 hours post-dose|Cycle 1 Day 1, 4 hours post-dose.|All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative.|||Participants|||Count of Participants
2579252|NCT02418000|Secondary|Number of Participants With Suppression of pERK at 24 Hours Post-dose|Measurement of phospho-ERK (pERK) in blood assessed by Western blot at 24 hours post-dose|Cycle 1 Day 1, 24 hours post-dose.|All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative.|||Participants|||Count of Participants
2579253|NCT02418000|Secondary|Number of Participants With Suppression of pERK at 4 Hours Post-dose|phospho-ERK (pERK) in blood assessed by Western blot at 4 hours post-dose|Cycle 1 Day 1, 4 hours post-dose.|All subjects in the FAS who completed at least 1 PD assessment. Data obtained were not quantitative.|||Participants|||Count of Participants
2579254|NCT02418000|Secondary|Pharmacokinetic Profile of E6201 in Plasma: VDobs|Measurement of apparent volume of distribution observed (VDobs)|Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported.|All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment.|||L||Standard Deviation|Mean
2579255|NCT02418000|Secondary|Pharmacokinetic Profile of E6201 in Plasma: CLobs|Clearance observed (CLobs): Total body clearance for extravascular administration|Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported.|All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment.|||L/h||Standard Deviation|Mean
2579256|NCT02418000|Secondary|Pharmacokinetic Profile of E6201 in Plasma: T1/2|T1/2: The apparent first-order elimination half-life|Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported.|All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment.|||h||Standard Deviation|Mean
2579257|NCT02418000|Secondary|Pharmacokinetic Profile of E6201 in Plasma: AUCI|AUCI: The area under the concentration versus time curve from time 0 to infinity|Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported.|All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment.|||h.ng/mL||Standard Deviation|Mean
2579258|NCT02418000|Secondary|Pharmacokinetic Profile of E6201 in Plasma: AUCT|Area under the plasma concentration versus time curve (AUC) to the last measurable concentration over the sampling time-interval.|Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported.|All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment.|||h.ng/mL||Standard Deviation|Mean
2579259|NCT02418000|Secondary|Pharmacokinetics of E6201 in Plasma: Tmax|Tmax: Time to maximum measured plasma concentration|Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported.|All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment.|||h||Standard Deviation|Mean
2579260|NCT02418000|Secondary|Pharmacokinetic Profile of E6201 in Plasma: Cmax|Cmax: Maximum measured plasma concentration over the collection period|Assessed at Cycle 1 Days 1 and 15, Cycle 2 Day 1, pre-dose, 5 minutes following the end of the 2-hour infusion, 2, 4, 8 and 24 hours post-infusion. Summary PK parameters for Cycle 1 Day 1 reported.|All subjects in the FAS who completed at least 1 pharmacokinetic (PK) assessment.|||ng/mL||Standard Deviation|Mean
2579261|NCT02418000|Secondary|Overall Survival|Length of time from the date of first administration of study drug to the date of death from any cause|From C1D1 until death or study closure, up to 26 months|The analysis population was the per-protocol set (PPS). The PPS included all subjects in the FAS who had a valid baseline and one or more post-treatment assessments for a specified endpoint.|||Days||Standard Deviation|Median
2605530|NCT02108223|Secondary|the Number of Oocytes Retrieved|median number of oocytes retrieved per participant|up to 9 month||||oocytes||Standard Deviation|Median
2579262|NCT02418000|Secondary|Progression-Free Survival|Length of time from the date of first administration of study drug to the first evidence of disease progression or death, whichever is earlier|From Cycle 1 Day 1 (C1D1) until death or study closure, up to 26 months|"The analysis population was the per-protocol set (PPS). The PPS included all subjects in the FAS who had a valid baseline and one or more post-treatment assessments for a specified measure.~For AML, MDS and CMML, progression was defined by relevant IWG criteria as failure to achieve at least a PR.~No responses; PFS could not be calculated."||||||
2579263|NCT02418000|Secondary|Duration of Response|Length of time from the first evidence of objective response to the first evidence of progression|At the end of C1 and every 2 cycles thereafter through 6 months following last dose of study drug|"The analysis population was the per-protocol set (PPS). The PPS included all subjects in the FAS who had a valid baseline and one or more post-treatment assessments for a specified measure.~No objective responses were observed. Therefore, duration of response could not be calculated."||||||
2579264|NCT02418000|Secondary|Overall Response Rate|"For acute myeloid leukemia (AML): Revised Recommendations of the International Working Group (IWG) Response Criteria for AML: CR: Free of leukemia-related symptoms, absolute neutrophil count (ANC) > 1.0 x 10^9/L, platelet count ≥ 100 x 10^9/L, normal bone marrow with < 5% blasts and no Auer rods. CRi: As per CR but w/ residual thrombocytopenia (platelet count <100 x 10^9/L) or residual neutropenia (ANC <1.0 x 10^9/L). PR: ≥50% decrease bone marrow blasts to 5 - 25% abnormal cells, or CR w/ ≤ 5% blasts if Auer rods present.~For myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML): Modified IWG Response Criteria for MDS: CR: Free of leukemia-related symptoms, ANC ≥1.0 x 10^9/L, platelet count ≥100 x 10^9/L, bone marrow ≤5% myeloblasts, normal maturation of all cell lines, hemoglobin ≥ 11g/dL, no blasts in the peripheral blood. PR: All CR criteria w/ ≥50% decrease in bone marrow blasts over pre-treatment, but still > 5%."|At the end of C1 and every 2 cycles thereafter through 6 months following last dose of study drug|The analysis population was the per-protocol set (PPS). The PPS included all subjects in the FAS who had a valid baseline and one or more post-treatment assessments for a specified measure.|||Objective Responses|||Number
2579265|NCT02418000|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|"A DLT was defined as any one of the following events: prolonged myelosuppression (as defined by the National Cancer Institute [NCI] criteria specific for leukemia, i.e., marrow cellularity < 5% at ≥ 6 weeks from start of therapy without evidence of leukemia); ≥ Grade 3 non-hematologic toxicity (excluding Grade 3 nausea, vomiting or diarrhea that is adequately controlled with supportive care and resolves to ≤ Grade 2 within 48 hours, or Grade 3 electrolyte disturbances responsive to correction within 24 hours); ≥ Grade 3 liver function tests (LFTs) lasting > 7 days; treatment interruption > 14 days due to toxicity; or other important medical event.~DLTs were collected to determine the MTD which is defined as the dose level below the dose at which ≥ 2 of 6 patients in a dose cohort experienced a DLT."|Up to 6 weeks for each dose cohort|Full analysis set (FAS): All subjects who were administered any fraction of a dose of study medication.|||Number of Participants with DLTs|||Number
2579266|NCT02418000|Primary|Maximum Tolerated Dose (MTD) of E6201|Phase 1 (Safety Run-In) was conducted in 5 dose cohorts in up to 30 subjects in a standard 3+3 dose-escalation design to establish an MTD and recommended Phase 2 dose (RP2D). Safety assessed through the monitoring of adverse events (AEs), serious adverse events (SAEs), clinical laboratory parameters (hematology and serum chemistry), vital sign measurements, electrocardiograms (ECGs) and physical examinations.|Up to 6 weeks for each dose cohort|Full analysis set (FAS): All subjects who were administered any fraction of a dose of study medication|||E6201 MTD (mg/m^2) IV twice weekly|||Number
2579267|NCT02417961|Secondary|The Immunogenicity of Benralizumab in the Terms of Anti-drug Antibodies (ADA)|Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive|Baseline until Week 28|Full analysis set - all patients who were administered for at least one dose of Benralizumab.|||Participants|||Number
2579268|NCT02417961|Secondary|The Pharmacodynamics of Benralizumab in the Terms of Peripheral Blood Eosinophil Levels|Blood eosinophil counts by timepoint|Baseline, Week 20, and Week 28|Full analysis set - all patients who were administered for at least one dose of Benralizumab.|||cells/ uL||Standard Deviation|Mean
2579269|NCT02417961|Secondary|The Pharmacokinetics (PK) of Benralizumab in the Terms of PK Parameters: Serum Concentration of Benralizumab|Mean PK Concentration at each visit|Baseline, Week 8, Week 20, and Week 28|PK analysis set - include all patients who had at least one quantifiable serum PK observation post first dose of Benralizumab.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2579270|NCT02417961|Secondary|The Effect of Benralizumab on Asthma Control Metrics in Terms of Change From Baseline in Mean Asthma Control Questionnaire-6 (ACQ-6) Score|The effect of benralizumab on asthma control metrics in terms of change from baseline in mean Asthma Control Questionnaire-6 (ACQ-6) score. ACQ-6 score is defined as the average of the first 6 items of the ACQ questionnaire on symptoms, activity limitations, and rescue medication. Baseline is defined as the last non-missing observation prior to the first dose of study treatment. ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Smaller score indicates better controlled asthma.|Week 0 (baseline) and weeks 4, 8, 12, 16, 20|Full analysis set - all patients who were administered for at least one dose of Benralizumab.|||Scores on a scale||Standard Deviation|Mean
2579271|NCT02417961|Primary|Number and Percentage of APFS Used to Administer Benralizumab at Home or in the Clinic and Have Been Reported as Malfunctioning (Product Complaints)|Number (%) of APFS used to administer benralizumab at home or in the clinic and have been reported as malfunctioning (Product Complaints). The percentage is calculated based on APFS dispensed and used for the specified time point.|Weeks 0, 4, 8, 12, 16, 0 to 8, 12 to 16, and 0 to 16|Number of Units analyzed per row represents number of accessorized pre-filled syringes used at each time point.|||Accessorized Pre-filled Syringe|Accessorized Pre-filled Syringe||Count of Units
2579334|NCT02417376|Secondary|Change From Baseline in C-Reactive Protein Level at 3 Month|Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 3 months.|Baseline and 3 months||||mg/L||Standard Deviation|Mean
2607247|NCT02092220|Secondary|1,5-anhydroglucitol on Day 12||Day 12 of each period|No data was collected for 1,5-anhydroglucitol.||||||
2579272|NCT02417961|Primary|Number and Percentage of Returned APFS Used to Administer Benralizumab at Home That Have Been Evaluated as Functional|"Number (%) of returned APFS used to administer benralizumab at home that have been evaluated as functional among all returned APFS used to administer benralizumab at home. A functional APFS is defined as an answer of Yes to all the questions in the visual inspection and function tests. The percentage is calculated among all returned APFS at the specified time point."|Week 12, Week 16|Full analysis set - all patients who were administered for at least one dose of Benralizumab.|||Participants|||Count of Participants
2579273|NCT02417961|Primary|Number and Percentage of Patients/Caregivers Who Successfully Administered Benralizumab 30 mg Subcutaneously (SC) by Injection With an APFS at Home|"Number (%) of patients/caregivers who successfully administered benralizumab with an APFS at home among those who have been deemed by the Principal Investigator to be suitable for at-home administration and are still in the study. A successful administration is defined as an injection completed, an answer of Yes to all 5 questions in the Functioning Device Return Questionnaire for the GREGALE Clinical Study (Appendix to the Clinical Study Protocol), and adequately passed the visual inspection and function tests. The percentage is calculated among all patients/caregivers who had been deemed by the Principal Investigator to be suitable for at home administration and were still in the study at the time point."|Week 12, Week 16, and Weeks 12 and 16|Full analysis set - all patients who were administered for at least one dose of Benralizumab.|||Participants|||Count of Participants
2579274|NCT02417935|Secondary|Number of Participants With a 30% and 50% Reduction in the Weekly Mean of the 24-Hour Average Pain Score on the 11-Point NRS at 12 Weeks|11-point NRS measures the severity of pain over the previous 24 hours. Patients were asked to provide 24-hour average pain scores in the daily patient diary. scores range from 0 (no pain) to 10 (pain as bad as you can imagine) and among these, the weekly mean of the 24-hour average pain score was calculated based on daily score.|Week 12|All randomized participants who received at least one dose of study drug & had baseline & at least one post-baseline observation for average pain score NRS .|||Participants|||Count of Participants
2579275|NCT02417935|Secondary|Change From Baseline to 12 Weeks in the Weekly Mean of the 24-Hour Worst Pain Scores on the 11-Point NRS|"24-hour worst pain severity scores were recorded on an 11-point NRS in the daily patient diary, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).The weekly mean of the worst pain score was calculated based on the daily score.~MMRM model with baseline value, duration of DPNP, treatment, week, treatment-by-week interaction as fixed effects was used to produce LS mean."|Baseline, Week 12|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for worst pain score NRS.|||units on a scale||Standard Error|Least Squares Mean
2579276|NCT02417935|Secondary|Change From Baseline to 12 Weeks in the Weekly Mean of Night Pain Scores on the 11-Point NRS|"Night pain severity scores were recorded on an 11-point NRS in the daily patient diary, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).The weekly mean of the night pain score was calculated based on the daily pain score.~MMRM model with baseline value, treatment, week, duration of DPNP and treatment-by-week interaction as fixed effects was used to produce LS mean."|Baseline, Week 12|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for night pain NRS.|||units on a scale||Standard Error|Least Squares Mean
2579277|NCT02417935|Secondary|Change From Baseline to 12 Weeks on the Beck Depression Inventory-II (BDI-II) Total Score|"Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.~MMRM model with baseline value, duration of DPNP, treatment, visit and treatment-by-visit interaction as fixed effects was used to produce LS mean."|Baseline, Week 12|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for BDI-II.|||units on a scale||Standard Error|Least Squares Mean
2579278|NCT02417935|Secondary|Change From Baseline to 12 Weeks on the EuroQol 5 Dimension (EQ-5D)|"The EQ-5D is a self-reported, 5-item scale used to assess the patient's health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale.These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm (range of the Index score is -0.111 - 1).A higher score indicates better health state.~ANCOVA model with LOCF with baseline value, treatment and duration of DPNP as fixed effects was used to produce LS mean."|Baseline, Week 12|All randomized participants who received at least one dose of study drug and had baseline and at least one post-baseline observation for EQ-5D.|||units on a scale||Standard Error|Least Squares Mean
2579279|NCT02417935|Secondary|Clinical Global Impression of Improvement (CGI-I) at 12 Weeks|"CGI-I measures clinician's perception of participant improvement at the time of assessment (compared with the start of treatment) with scores ranging from 1 (very much better) to 7 (very much worse).~MMRM model with duration of DPNP, treatment, visit and treatment-by-visit interaction as fixed effects was used to produce LS Mean."|Week 12|All randomized participants who received at least one dose of study drug and had at least one post baseline observation for CGI-I|||units on a scale||Standard Error|Least Squares Mean
2579280|NCT02417935|Secondary|Change From Baseline to 12 Weeks on the Neuropathic Pain Symptom Inventory (NPSI)|"NPSI questionnaire is a 12-item self-administered questionnaire that will be completed by the participant. It assesses 5 different dimensions of neuropathic pain on a scale of 0 (no symptom) to 10 (worst imaginable symptom): burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesias/dysesthesias. The NPSI includes 12 items: 10 descriptors of the different symptoms and 2 items for assessing the duration of spontaneous ongoing and paroxysmal pain. A total score can be calculated as the sum of the scores of the 10 descriptors with scale range: 0 (no pain) -100 (worst pain imaginable).~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) with baseline, treatment, and duration of DPNP as fixed effects was used to produce LS mean."|Baseline, Week 12|All randomized participants who received at least one dose of study drug & had baseline & at least one post-baseline observation for NPSI.|||units on a scale||Standard Error|Least Squares Mean
2579335|NCT02417376|Secondary|Change From Baseline in C-Reactive Protein Level at 1 Month|Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 1 month.|Baseline and 1 month||||mg/L||Standard Deviation|Mean
2579281|NCT02417935|Secondary|Change From Baseline to 12 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)|"Brief Pain Inventory Severity and Interference Scores: BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (pain as bad as you can imagine) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.~MMRM model with baseline, duration of DPNP, treatment, visit, treatment-by-visit interaction as fixed effects was used to produce LS mean."|Baseline, Week 12|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for BPI-SF.|||units on a scale||Standard Error|Least Squares Mean
2579282|NCT02417935|Secondary|Patient Global Impression of Improvement (PGI-I) at 12 Weeks|"PGI-I assessments was completed by the participant. The participant records how he/she perceives the degree of improvement (or worsening) at the time of assessment since taking treatment. The score ranges from 1 (very much better) to 7 (very much worse).~MMRM model with duration of DPNP, treatment, visit, treatment-by-visit interaction as fixed effects was used to produce LS Mean."|Week 12|All randomized participants who received at least one dose of study drug and had at least one post baseline observation.|||units on a scale||Standard Error|Least Squares Mean
2579283|NCT02417935|Primary|Change From Baseline to 12 Weeks in the Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale (NRS)|"11-point NRS measures the severity of pain over the previous 24 hours. Participants were asked to provide 24-hour average pain scores in the daily Participant diary and among these, the weekly mean of the 24-hour average pain score was calculated. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine).~Mixed Model Repeated Measures (MMRM) model with baseline value, Duration of diabetic peripheral neuropathic pain (DPNP), treatment, week, treatment-by-week interaction as fixed effects was used to produce Least Square Mean (LS Mean)."|Baseline, Week 12|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline observation for NRS.|||units on a scale||Standard Error|Least Squares Mean
2579284|NCT02417844|Secondary|Apparent Terminal Elimination Half-life (t1/2)|Apparent terminal elimination half-life of the analyte in plasma (t1/2)|Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PK set|||hours||Geometric Coefficient of Variation|Geometric Mean
2579285|NCT02417844|Secondary|Terminal Elimination Rate Constant (λz)|Terminal elimination rate constant in plasma (λz)|Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PK set|||1/hour||Geometric Coefficient of Variation|Geometric Mean
2579286|NCT02417844|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time from last dosing to the maximum plasma concentration (tmax).|Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PK set|||Hours||Full Range|Median
2579287|NCT02417844|Primary|Area Under the Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-inf)|Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).|Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PK set|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2579288|NCT02417844|Primary|Area Under the Concentration-time Curve From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)|Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PK set|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2579289|NCT02417844|Primary|Maximum Measured Concentration (Cmax)|Maximum measured concentration of analyte in plasma (Cmax)|Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set which included all subjects who had evaluable PK data for both treatment periods.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2579290|NCT02417831|Secondary|t1/2|"Apparent terminal elimination half-life of the analyte in plasma (t1/2)~Geometric Coefficient of Variation (gCV) is actually inter-individual gCV."|Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.|PK set|||Hours||Geometric Coefficient of Variation|Geometric Mean
2579291|NCT02417831|Secondary|λz|"Terminal elimination rate constant in plasma (λz).~Geometric Coefficient of Variation (gCV) is actually inter-individual gCV."|Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.|PK set|||1/hours||Geometric Coefficient of Variation|Geometric Mean
2579292|NCT02417831|Secondary|Tmax|Time to maximum plasma concentration|Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.|PK set|||Hours||Full Range|Median
2579293|NCT02417831|Primary|(AUC0-inf)|"Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).~Geometric Coefficient of Variation (gCV) is actually inter-individual gCV."|Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.|PK set|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2579294|NCT02417831|Primary|AUC0-tz|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz).~Geometric Coefficient of Variation (gCV) is actually inter-individual gCV."|Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.|PK set|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2579707|NCT02413593|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12||Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2579295|NCT02417831|Primary|Cmax|Maximum measured concentration in plasma (Cmax). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.|Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.|Pharmacokinetic set (PK set): All subjects who had evaluable pharmacokinetic (PK) data for both treatment periods were included in the statistical PK analysis for the study.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2579296|NCT02417753|Secondary|Overall Survival (PFS) in Patients With Malignant Ascites Treated With AZD9150|OS is defined as the time from the first day of treatment to the day of death.|1.5 years|This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.||||||
2579297|NCT02417753|Secondary|Progression Free Survival (PFS) in Patients With Malignant Ascites Treated With AZD9150|PFS is the time interval from start of treatment to documented evidence of progressive disease. Progressive disease was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). in addition to the relative increase of 29%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).|1.5 years|This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.||||||
2579298|NCT02417753|Secondary|Count of Participants With Serious and Non Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|4 months and 15 days||||Participants|||Count of Participants
2579299|NCT02417753|Secondary|Response Rate (RR) in Patients With Malignant Ascites Treated With AZD9150|Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is measured from the time measurement criteria are met for complete response or partial response (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|1.5 years|This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.||||||
2579300|NCT02417753|Secondary|Reduction in Tyrosine-phosphorylated Signal Transducer and Activator of Transcription 3 (STAT3) Phospho- Signal Transducer and Activator of Transcription 3 (p- STAT3) Expression, Comparing Before and After Therapy, in Ascites and Peripheral Blood|Measure the reduction in tyrosine-phosphorylated STAT3 (p=STAT3) expression.|1.5 years|This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.||||||
2579301|NCT02417753|Secondary|Effect on Signal Transducer and Activator of Transcription 3(STAT3)-Dependent & Associated Signaling Both in Tumor Cells, Peripheral Blood and the Microenvironment, Including Modulations in Chemokine and Cytokine Response Following Treatment With AZD9150|Serum samples were to be collected from participants and assessed for interferon, cytokine and chemokine levels including interferon, ϒ-interferon inducible protein (IP-10), monocyte chemoattractant protein 1 (MCP-1), interleukin 6 (IL-6), interleukin 8 (IL-8), interleukin 10 (IL-10), and interleukin 12/p70 (IL-12/p70).|1.5 years|This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.||||||
2579302|NCT02417753|Primary|Changes in Immune Parameters in the Malignant Ascites of Patients With Advanced Cancer Following Therapy With AZD9150|Participants were to undergo research paracentesis. Ascitic fluid was to be obtained and processed for changes in the percentages of memory cluster of differentiation 8 (CD8) + cells, regulatory T cells, plasmacytoid dendritic cell (pDC), B cells and natural killer (NK) cells will be analyzed by flow cytometry.|1.5 years|This outcome measure was not done because the one patient did not make it to one scan after 8 weeks.||||||
2579303|NCT02417532|Secondary|Timed up and go Test- Ability to Stand From Chair|The number of seconds required to walk 3 m and turn around and walk back to the chair. (Functional test)|1 Day|Subjects who were able to control the joystick. One patient was unable to control the joystick and was excluded.|||seconds||Standard Deviation|Mean
2579304|NCT02417532|Secondary|Participant Satisfaction Questionnaire|overall user satisfaction with the device|1 Day|Patients who were able to transfer into REX and who could control the joystick. One patient was unable to walk and control Rex so did not complete the questionaire.|||percentage of patients|||Number
2579305|NCT02417532|Primary|Transfer Time|Time it took for participant to transfer into the Rex with or without supervision.|1 day|All patients transferring into Rex|||seconds||Standard Deviation|Median
2579306|NCT02417532|Primary|Adverse Events|absence of unexpected serious adverse events|1 day|All patients transferring into Rex.|||Participants|||Count of Participants
2579307|NCT02417532|Primary|Ability to Transfer|Completion of transfer with supervision or 1 assistant from wheelchair or bed into REX|1 day|All subjects meeting inclusion criteria. Physically able to properly fit in REX.|||participants|||Number
2579308|NCT02417441|Post-Hoc|Number of Sites With Subjects Reporting Fetal Heart Beat (FHB) Positive Implantation Rate (IR)|"Number of sites with subjects reporting fetal heart beat (FHB) positive implantation rate (IR) were reported. Overall combined data for Early Embryo Viability Assessment + Morphological Grading and Morphological Grading arm was planned to be reported."|Gestational Weeks 5 to 8|"Subgroup analysis set included subjects reporting positive fetal heart beat implantation rate from both “Early Embryo Viability Assessment and Morphological grading arm and Morphological grading arm”. Here, Number of Subjects analyzed signifies those who were evaluable for this outcome measure."|||Sites|Sites||Number
2579336|NCT02417376|Primary|Change From Baseline in C-Reactive Protein Level at 6 Months|Change from baseline in high-sensitivity C-reactive protein level assessed quantitatively by immunoturbidimetric analysis at 6 months.|Baseline and 6 months|All patients suffered from CHD and Periodontitis both.|||mg/L||Standard Deviation|Mean
2579309|NCT02417441|Other Pre-specified|Eeva Conformity in Early Embryo Viability Assessment + Morphological Grading Group for Day 5/6 Embryo Transfer (ET)|"Eeva Conformity was reported as the number of subjects who were compliant to use Eeva in embryo assessment in the Early Embryo Viability Assessment + morphological grading group. Eeva-compliance subgroup refers to subjects whose embryos were assessed by embryologists following the recommendation of Eeva system and the IFU of Eeva. Subgroup analysis revealed a high incidence of Eeva noncompliance in the experimental group, which compromised the quality of this study. Only Early Embryo Viability Assessment + Morphological Grading reporting arm was applicable for this outcome measure."|Day 5/6 of embryo culture|Subgroup Analysis Set included subjects from “Early Embryo Viability Assessment + morphology grading” group for whom the embryologist has followed the recommendation of the Eeva system. Here, Number of Subjects analyzed signifies those who were evaluable for this outcome measure.|||Subjects|||Number
2579310|NCT02417441|Other Pre-specified|Eeva Conformity in Early Embryo Viability Assessment + Morphological Grading Group for Day 3 Embryo Transfer (ET)|"Eeva Conformity was reported as the number of subjects who were compliant to use Eeva in embryo assessment in the Early Embryo Viability Assessment + morphological grading group. Eeva-compliance subgroup refers to subjects whose embryos were assessed by embryologists following the recommendation of Eeva system and the instructions for use (IFU) of Eeva. Subgroup analysis revealed a high incidence of Eeva noncompliance in the experimental group, which compromised the quality of this study. Only Early Embryo Viability Assessment + Morphological Grading reporting arm was applicable for this outcome measure."|Day 3 of embryo culture|Subgroup Analysis Set included subjects from “Early Embryo Viability Assessment + morphology grading” group for whom the embryologist has followed the recommendation of the Eeva system. Here, Number of Subjects analyzed signifies those who were evaluable for this outcome measure.|||Subjects|||Number
2579311|NCT02417441|Secondary|Spontaneous Miscarriage Rate|Spontaneous miscarriage rate was measured by the number of spontaneous miscarriages as communicated during medical appointment or by telephone contact divided by number of clinical pregnancies multiplied by 100.|Gestational Weeks 10 to 12|The intention-to-treat population included all randomized subjects.|||Percentage of miscarriages|||Number
2579312|NCT02417441|Secondary|Utilization Rate|Utilization rate was defined as the sum of number of transferred and frozen embryos divided by number of normally fertilized oocytes multiplied by 100.|Day 3 or Day 5/6 of embryo culture|The intention-to-treat population included all randomized subjects.|||Percentage of embryos||95% Confidence Interval|Number
2579313|NCT02417441|Secondary|Multiple Pregnancy Rate|Multiple pregnancy rate was defined as a clinical pregnancy with greater than equals to (>=) 2 fetal sacs as assessed by ultrasonography. Multiple Pregnancies rate was measured by number of multiple pregnancies divided by number of embryo transfer cycles multiplied by 100.|Gestational Weeks 5 to 8|The intention-to-treat population included all randomized subjects.|||Percentage of pregnancy per transfer||95% Confidence Interval|Number
2579314|NCT02417441|Secondary|Number of Subjects With Ongoing Pregnancy Status|"Ongoing pregnancy was defined as having a positive fetal heart beat (FHB) as assessed by ultrasonography at gestational week 10-12. Number of subjects with ongoing pregnancy status has been reported, where Yes indicates participants with positive ongoing pregnancy status and No indicates participants with negative ongoing pregnancy status ."|Gestational Weeks 10 to 12|The intention-to-treat population included all randomized subjects.|||Subjects|||Number
2579315|NCT02417441|Secondary|Clinical Pregnancy Rate|Clinical pregnancy was confirmed by the presence of a gestational sac with heartbeat as assessed by ultrasonography. Clinical pregnancy rate was measured as the number of clinical pregnancies divided by number of embryo transfer (ET) cycles multiplied by 100.|Gestational Weeks 5 to 8|The intention-to-treat population included all randomized subjects.|||Percentage of pregnancy per transfer||95% Confidence Interval|Number
2579316|NCT02417441|Primary|Implantation Rate|Implantation rate was calculated by dividing the number of intrauterine gestational sacs by the number of embryos transferred multiplied by 100.|Gestational Weeks 5 to 8|The intention-to-treat population included all randomized subjects.|||% of sacs per embryo transferred||95% Confidence Interval|Number
2579317|NCT02417376|Secondary|Diastolic Blood Pressure at 6 Months|Diastolic blood pressure at 6 months.|6 months||||mmHg||Standard Deviation|Mean
2579318|NCT02417376|Secondary|Diastolic Blood Pressure at 3 Months|Diastolic blood pressure at 3 months.|3 months||||mmHg||Standard Deviation|Mean
2579319|NCT02417376|Secondary|Diastolic Blood Pressure at 1 Month|Diastolic blood pressure at 1 month.|1 month||||mmHg||Standard Deviation|Mean
2579320|NCT02417376|Secondary|Change From Baseline Periodontal Parameter- Clinical Attachment Loss at 6 Months|Change from baseline in periodontal parameter- clinical attachment loss at 6 months.|Baseline and 6 months||||mm||Standard Deviation|Mean
2579321|NCT02417376|Secondary|Change From Baseline Periodontal Parameter- Bleeding on Probing at 6 Months|Change from baseline in periodontal parameter- bleeding on probing at 6 months.|Baseline and 6 months||||percentage of sites||Standard Deviation|Mean
2579322|NCT02417376|Secondary|Change From Baseline Periodontal Parameter- Plaque Index at 6 Months|Change from baseline in periodontal parameter- plaque index at 6 months. Scale ranges for Total Plaque Index - Minimum score (0) and maximum score (3). Score 0 represents better outcome and higher scores represent worst outcome. Score per person are calculated by taking average of scores for 6 sites of all teeth recorded.|Baseline and 6 months||||Scores on a scale||Standard Deviation|Mean
2579323|NCT02417376|Secondary|Change From Baseline Periodontal Parameter- Gingival Index at 6 Months|"Change from baseline in periodontal parameter- gingival index at 6 months. Scale ranges for Total Gingival Index - Minimum score (0) and maximum score (3).~Score 0 represents better outcome and higher scores represent worst outcome. Score per person are calculated by taking average of scores for 6 sites of all teeth recorded."|Baseline and 6 months||||Scores on a scale||Standard Deviation|Mean
2579324|NCT02417376|Secondary|Change From Baseline Periodontal Parameter- Periodontal Probing Depth at 6 Months|Change from baseline in periodontal parameter- periodontal probing depth at 6 months.|Baseline and 6 months||||mm||Standard Deviation|Mean
2579325|NCT02417376|Secondary|Systolic Blood Pressure at 6 Months|Systolic blood pressure at 6 months.|6 months||||mmHg||Standard Deviation|Mean
2579326|NCT02417376|Secondary|Systolic Blood Pressure at 3 Months|Systolic blood pressure at 3 months.|3 months||||mmHg||Standard Deviation|Mean
2579327|NCT02417376|Secondary|Systolic Blood Pressure at 1 Month|Systolic blood pressure at 1 month.|1 month||||mmHg||Standard Deviation|Mean
2579337|NCT02417246|Secondary|Heart Rate (HR) Response Compared Between Brand Name Metoprolol ER and Each Generic (Generic B, Generic A) Formulation of Metoprolol Succinate|24-h ambulatory heart rate recordings taken 4 times per hour (every 15 minutes) between 6AM and 11PM and 2 times per hour (every 30 minutes) 11PM and 6AM were obtained after Phase 1 (brand name metoprolol ER), Phase 2 (Generic B or Generic A), and Phase 4 (Generic A or Generic B)|Average value over each quartile of 6 hours in the 24-hr period|The analysis aimed to compare 24-hr HR between the brand name and each generic (generic B or generic A) formulation of metoprolol succinate. Mean and SD values for HR entered for each medication by quartile|||bpm||Standard Deviation|Mean
2579338|NCT02417246|Secondary|Blood Pressure Values (Systolic and Diastolic) Compared Between Brand Name Metoprolol ER and Each Generic Metoprolol Formulation (Generic B, Generic A)|24-hr ambulatory blood pressure (BP) recordings taken 4 times per hour (every 15 minutes) between 6AM and 11PM and 2 times per hour (every 30 minutes) 11PM and 6AM were obtained after Phase 1 (Brand name metoprolol ER), Phase 2 (Generic B or Generic A), and Phase 4 (Generic A or Generic B).|Average value over each quartile of 6 hours in the 24-hr period|The analysis aimed to compare mean BP values in Hg mm between the brand name and each of the generic (Generic B or Generic A) formulation of metoprolol succinate. Patients were included in the analysis if they took brand name metoprolol ER and at least one generic.|||mm Hg||Standard Deviation|Mean
2579339|NCT02417246|Secondary|The Heart Rate Variability (HRV) Response to Brand Name Metoprolol ER Versus Each Generic Formulation of Metoprolol Succinate.|24-h digital heart rate monitor analyses were obtained after Phase 1 (brand name metoprolol ER ), Phase 2 (Generic B or Generic A), and Phase 4 (Generic A or Generic B). Data were analyzed by quartiles. One 5-minute epoch from each hour of each quartile was selected based on absence of a significant number of ectopic beats and artifact from which spectral measures were calculated: high-frequency variability (measure of parasympathetic activity), low-frequency variability (measure of sympathetic activity). The ratio of low-to-high frequency variability was calculated for each quartile. The averages of values obtained for each hour of each quartile constituted the final quartile measures that were used for analysis. The low to high frequency ratio obtained for each quartile represents the balance between sympathetic and parasympathetic nervous system activity and was the primary variable for heart rate variability analysis.|Heart rate variability (Low-to-High Frequency Ratio) over each quartile of 6 hours in the 24-hr period|The analysis aimed to compare HRV (Low-to-High Frequency Ratio) for patients who took Brand name metoprolol ER and a generic formulation (Generic B or Generic A). Low to High Frequency Ratio values are entered for each quartile for Brand name metoprolol ER, Generic B and Generic A|||no units||Standard Deviation|Mean
2579340|NCT02417246|Primary|Peak Plasma Concentration (Cmax) of Metoprolol Succinate|The Peak Plasma Concentration (Cmax) of Brand name metoprolol ER will be compared against each generic for determination of bioequivalence. The mean and SD values of Cmax are entered separately for the 50mg, 100mg and 150mg doses. Results are reported for brand name metoprolol ER, Generic B and Generic A.|0.0, 0.30, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 20.0, 24.0 hours post dose|A two-way cross over study in which patients are administered brand name metoprolol ER and Generic B or Generic A|||ng/mL||Standard Deviation|Mean
2579341|NCT02417246|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC)|The AUC of Brand name metoprolol ER will be compared against each generic for determination of bioequivalence. The mean and standard deviation (SD) values of AUC are entered separately for the 50mg, 100mg and 150mg doses. Results are reported for brand name metoprolol ER, Generic B and Generic A.|0.0, 0.30, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 20.0, 24.0 hours post dose|This is a 2-way crossover analysis|||ng.hr/ml|Plasma|Standard Deviation|Mean
2579342|NCT02417233|Primary|Adherence to ART - Subjective (Self-reported Ability to Take ART as Prescribed in Last Month)|"Self-reported ability to take ART as prescribed in last month, assessed at 12 months from enrollment. Considered compliant if reported very good or excellent adherence."|12 months|Analysis population is all enrolled participants prescribed ART who returned to answer the 12 month survey.|||Participants|||Count of Participants
2579343|NCT02417233|Primary|Adherence to ART - Objective (Viral Load Test Results <400 Copies/mL)|Viral load test results <400 copies/mL (consistent with current and correct adherence to ART)|12 months|Analysis population is all enrolled participants who were prescribed ART and had received viral load testing by 12 months of study enrollment|||Participants|||Count of Participants
2579344|NCT02417233|Primary|Retention in Care - Non-ART (Participants Who Return for Repeat CD4 Testing Within 12 Months of Diagnosis)|Participants who return for repeat CD4 testing within 12 months of diagnosis|12 months|Analysis population is all enrolled participants who were not prescribed ART|||Participants|||Count of Participants
2579345|NCT02417233|Primary|Retention in Care - ART Eligible (Participants Eligible for ART Who Initiated ART and Who Remain on Treatment)|Participants eligible for ART who initiated ART and who remain on treatment 12 months from enrollment. Retention in care at 12 months is defined as at least 4 clinical care visits with less than 4 months between each visit.|12 months|Analysis population is all enrolled participants who were prescribed ART.|||Participants|||Count of Participants
2579346|NCT02417233|Primary|Timely Antiretroviral Therapy (ART) Initiation (Participants Eligible for ART Who Initiate Treatment Within 3 Months of Diagnosis)|Participants eligible for ART who initiate treatment within 3 months of diagnosis|3 months|Analysis population is participants who were newly diagnosed HIV+ within 7 days of study enrollment|||Participants|||Count of Participants
2579347|NCT02417233|Primary|Linkage to Care - Participants Who Received Cluster of Differentiation 4 (CD4) T-cell Count Test Result Within 3 Months of Testing HIV-positive (Binary)|Participants who received CD4 count test result within 3 months of testing HIV-positive (binary)|3 months|Analysis population is participants who were newly diagnosed HIV+ within 7 days of study enrollment|||Participants|||Count of Participants
2579348|NCT02417129|Secondary|Immunogenicity at Week 30|"Immunogenicity (rate of anti-drug antibodies) at Week 30 presented as the number of participants having Immunogenicity at Week 30.~This endpoint was not summarized for arm ' rituximab ', as two patient were randomized and treated with BI 695500, thus no patient was treated with rituximab in this trial."|Day 204 or end of study|Safety Analysis Set (SAF). As the program was prematurely discontinued and only two patients were randomized at the time of discontinuation, the planned statistical analysis was not performed.|||participants|||Number
2580074|NCT02410824|Primary|Lens Durability|Lens durability (lens tearing) between stenfilcon A toric lens or etafilcon A toric lens assessed at 1 week. (The number of lens tear or lens nicks found during the one week study).|1 Week||||Lens tear or nick|Lenses||Number
2579349|NCT02417129|Secondary|Extrapolated Area Under the Concentration-time Curve of BI 695500 or Rituximab at Steady State Over the Interval 0 Hour (h) to the Next Dose of Trial Medication (AUC0-τ, ss)|Extrapolated area under the concentration-time curve of BI 695500 or rituximab in plasma at steady state over the interval 0 hour (h) to the next dose of trial medication (AUC0-τ, ss) established by population pharmacokinetics.|Sample timepoints Day 1, 8, 22, 23-24 (24-48 hours from start of Cycle 4 infusion), 24-26 (48-96 hours from start of Cycle 4 infusion), 26-36 (96-336 hours from start of Cycle 4 infusion), 78, 134, 204|As the program was prematurely discontinued and only two patients were randomized at the time of discontinuation, the planned statistical analysis was not performed.||||||
2579350|NCT02417129|Primary|Overall Response Measured as Overall Response Rate (ORR) at Week 30 for BI 695500 Versus Rituximab|"The primary objective of this trial was to evaluate statistical equivalence of efficacy as assessed by Overall Response (measured as Overall Response Rate (ORR)) at Week 30 for treatment with BI 695500 versus rituximab (Rituxan®) in patients with untreated low tumor burden follicular lymphoma (LTBFL).~The overall response measured as Overall Response Rate (ORR), which is the completed response (CR) and the partial response (PR) at Week 30, approximately 26 weeks after the completion of study treatment, as defined by International Working Group (IWG) criteria 2007 via an independent radiology assessment.~Two patient were randomized and treated with BI 695500, whereas no patient was treated with rituximab in this trial."|From first administration of study medication until 30 weeks thereafter.|As the program was prematurely discontinued and only two patients were randomized at the time of discontinuation, the planned statistical analysis was not performed.|||participants|||Number
2579351|NCT02417064|Secondary|Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to End of Double-blind Induction Phase (Day 28): Sum Score|EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). The descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each has 5 levels (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses are used to generate Health Status Index (HSI). HSI range is -0.148 to 0.949, is anchored at 0 (dead) and 1 (full health). EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state.|Baseline up to end of Double-blind Induction phase (Day 28)|FAS: all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2579352|NCT02417064|Secondary|Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to End of Double-blind Induction Phase (Day 28): EQ-VAS|EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine).|Baseline up to end of Double-blind induction phase (Day 28)|FAS: all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2579353|NCT02417064|Secondary|Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to End of Double-blind Induction Phase (Day 28): Health Status Index|EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). The descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses are used to generate Health Status Index (HSI). HSI range is -0.148 to 0.949, is anchored at 0 (dead) and 1 (full health).|Baseline up to End of Double-blind Induction Phase (Day 28)|FAS: all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2579354|NCT02417064|Secondary|Change From Baseline in Generalized Anxiety Disorder-7 Item (GAD-7) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])|"GAD-7 is a brief and validated 7-item self-reported assessment of overall anxiety. Participants responded to each item using a 4 point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15-21). Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase."|Baseline up to Double-blind Endpoint (Day 28)|FAS: all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2579355|NCT02417064|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score up to Endpoint (Double-blind Induction Phase [Day 28])|"CGI-S provides measure of severity of participant's illness including participant's history, psychosocial circumstances, symptoms, behavior and impact of symptoms on ability to function. CGI-S evaluates severity of psychopathology on scale of 0 to 7. Considering total clinical experience, participant is assessed on severity of mental illness according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients (a decrease in score indicates improvement). Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase."|Baseline up to Double-blind Endpoint (Day 28)|FAS: all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Full Range|Median
2579356|NCT02417064|Secondary|Percentage of Participants in Remission (MADRS<=12) at the Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis (LOCF Data)|"Participants who had a MADRS total score of less than or equal to (<=) 12 were considered as remitters. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase."|At Day 28 (Double-blind Endpoint)|FAS: all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
2579357|NCT02417064|Secondary|Percentage of Participants in Remission (MADRS<=12) at Day 28 of Double-blind Induction Phase (Observed Data)|Participants who had a MADRS total score of less than or equal to (<=) 12 were considered as remitters. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.|At Day 28 of Double-blind Induction Phase|FAS: all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
2579358|NCT02417064|Secondary|Percentage of Participants Who Achieved at Least 50% Reduction From Baseline in MADRS Total Score at the Endpoint (Double-blind Induction Phase [Day 28]) (LOCF Data)|"A participant was defined as a responder (yes=1 and no=0) at a given time point if the percent reduction from baseline in MADRS total score is at least 50 percent (%). The percentage of participants who achieved at least 50% reduction from baseline were reported. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase."|At Day 28 (Double-blind Endpoint)|FAS: all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2579359|NCT02417064|Secondary|Percentage of Participants Who Achieved at Least 50% Reduction From Baseline in MADRS Total Score at Day 28 of Double-blind Induction Phase (Observed Data)|A participant was defined as a responder (yes=1 and no=0) at a given time point if the percent reduction from baseline in MADRS total score is at least 50 percent (%). The percentage of participants who achieved at least 50% reduction from baseline were reported. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.|At Day 28 of Double-blind Induction phase|FAS: all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2579360|NCT02417064|Secondary|Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis|"PHQ-9 is 9-item, self-reported scale assessing 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders, Major Depressive Disorder criteria. Each item is rated on 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half days, 3 = Nearly every day). The scores are summed for a total score ranging from 0-27. Higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27). The recall period is 2 weeks. Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase."|Baseline up to Double-blind Endpoint (Day 28)|FAS: all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2579361|NCT02417064|Secondary|Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis|PHQ-9 is 9-item, self-reported scale assessing 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders, Major Depressive Disorder criteria. Each item is rated on 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half days, 3 = Nearly every day). The scores are summed for a total score ranging from 0-27. Higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27). The recall period is 2 weeks.|Baseline up to Day 28 of Double-blind Induction phase|FAS: all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2607248|NCT02092220|Secondary|Glycated Albumin on Day 12||Day 12 of each period|No data was collected for Glycated Albumin.||||||
2579362|NCT02417064|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis|"The SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1) work/school, 2) social life, and 3) family life/home responsibilities using 0 (not at all) to 10 (extremely) rating scale. Score for first 3 items are summed to create total score of 0 (unimpaired) to 30 (highly impaired) where higher score indicates greater impairment. Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase."|Baseline up to Double-blind Endpoint (Day 28)|FAS: all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2579363|NCT02417064|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis|The SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1) work/school, 2) social life, and 3) family life/home responsibilities using 0 (not at all) to 10 (extremely) rating scale. Score for first 3 items are summed to create total score of 0 (unimpaired) to 30 (highly impaired), where higher score indicates greater impairment.|Baseline up to Day 28 of Double-blind Induction phase|FAS: all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2579364|NCT02417064|Secondary|Percentage of Participants With Onset of Clinical Response by Day 2 and Day 8|A participant was defined as having a clinical response if there was at least 50% improvement (decrease) from baseline in the MADRS total score with onset by Day 2 and Day 8 that was maintained to Day 28. Participants were allowed one excursion (non-response) on Days 8, 15 or 22, however score must show at least 25% improvement. Participants who did not meet these criteria or discontinued during the study before Day 28 were considered as non-responders and were assigned the value of 0 (that is no). MADRS is clinician-rated scale that consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), for total possible score of 0 to 60. Higher scores represent more severe condition.|Day 2 up to Day 28 and Day 8 up to Day 28|FAS: all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral AD medication during the double-blind induction phase.|||Percentage of Participants|||Number
2579365|NCT02417064|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis|"MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Missing data was imputed using Last Observation Carried Forward (LOCF) method and last post baseline observation during double-blind induction phase was carried forward as End Point for that phase."|Baseline up to Double-blind Endpoint (Day 28)|Full analysis set (FAS): all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during double-blind induction phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2579366|NCT02417064|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 of Double- Blind Induction Phase- Mixed- Effects Model Using Repeated Measures (MMRM) Analysis|MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.|Baseline up to Day 28 of Double-blind Induction Phase|Full analysis set (FAS): all randomized participants who received at least 1 dose of intranasal study medication and 1 dose of oral antidepressant medication during double-blind induction phase. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2579367|NCT02416973|Primary|Percent Change From Baseline in Pain Scores|Numerical Pain Rating Scale (NPRS) was used to score pain at Baseline and at End of Treatment. The Percent change (difference) from Baseline to End of Treatment was calculated. The NPRS is an 11-point scale ranging from scores of 0 (no pain) to 10 (worst pain imaginable).|60 days|Per protocol population results displayed. This results in a discrepancy in the number of participants provided above. Baseline characteristics include the entire intent to treat population.|||Percent Difference||Standard Deviation|Mean
2579368|NCT02416934|Secondary|Fusion Rate Steroid vs Placebo|Participants were considered fused if radiographs demonstrated less than 1 millimeter of interspinous motion between flexion and extension,7 or if CT/MRI demonstrated clear evidence of bone bridging from endplate to endplate.|1 year||||Participants|||Count of Participants
2579369|NCT02416934|Secondary|Change in Quality of Life|Change in Quality of life measured by the Neck Disability Index (NDI) from baseline and 1 year for Treatment 1; Dexamethasone and Treatment 0; Saline placebo. The NDI measures self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is 50. The higher the score the more disability. The scale is 0 - 4 = no disability; 5 - 14 = mild;15 - 24 = moderate; 25 - 34 = severe; above 34 = complete disability.|Baseline and 1 year (or last visit as appropriate). Not all subjects followed up at 1 year.|Neck Disability Index change from baseline to 1 year or last visit as appropriate. Not all subjects followed up at 1 year.|||units on a scale||Standard Error|Mean
2607396|NCT02090426|Secondary|Number of Readmissions||180-day from indexed hospital discharge||||readmissions||Standard Deviation|Mean
2579370|NCT02416934|Primary|Swallowing Difficulty|Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score of zero indicates no symptoms. Any number above zero indicates difficulty swallowing. The Bazaz score of Zero indicates no symptoms. Any number above zero indicates difficulty swallowing. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are listed below associated with the randomization assignment and survey used.|1 day; 2 days; 1 week; 2 weeks; 1 month; 3 months; 6 months;12 months|Treatment 1; Dexamethasone or Treatment 0; Saline placebo. Treatment 1 received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. Dosage was approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Treatment 0 received similar volume of saline on same schedule for three doses.|||Participants|||Count of Participants
2579371|NCT02416908|Secondary|Number of Participants Who Were Able to Undergo Hematopoietic Stem Cell Transplantation|Allogeneic stem cell transplant utilization: the number of patients proceeding to allogeneic transplant within 2 months following end of study without any additional salvage therapy following study treatment.|Up to 2 years (median follow-up of 307 days)|-Phase I Schedule A Arm and Phase II Arm data was combined as all participants received the same dose and schedule of the study regimen.|||Participants|||Count of Participants
2579372|NCT02416908|Secondary|Overall Survival|Overall survival (OS): Defined as the date of first dose of study drug to the date of death from any cause. OS will be evaluated at 3 month intervals for at least 12 months and up to a maximum of 2 years.|Up to 2 years (median follow-up of 307 days)|-Phase I Schedule A Arm and Phase II Arm data was combined as all participants received the same dose and schedule of the study regimen.|||months||95% Confidence Interval|Median
2579373|NCT02416908|Secondary|Relapse-free Survival|Relapse-free survival (RFS): For patients achieving a complete remission, defined as the interval from the date of first documentation of a leukemia free state to date of recurrence or death due to any cause.|Median follow-up of 307 days|-Phase I Schedule A Arm and Phase II Arm data was combined as all participants received the same dose and schedule of the study regimen.|||days||Full Range|Median
2579374|NCT02416908|Secondary|Duration of Remission|-Duration of remission (DOR): Defined as the interval from the date complete remission is documented to the date of recurrence.|Up to 2 years|-Phase I Schedule A Arm and Phase II Arm data was combined as all participants received the same dose and schedule of the study regimen.|||months||95% Confidence Interval|Median
2579375|NCT02416908|Secondary|Event-free Survival|Event-free survival (EFS): Defined as the interval from the date of first dose of study drug to date of treatment failure including progressive disease, recurrence, or discontinuation for any reason (including toxicity, patient preference, initiation of new treatment without documented progression, or death due to any cause).|Up to 2 years (median follow-up of 307 days)|-Phase I Schedule A Arm and Phase II Arm data was combined as all participants received the same dose and schedule of the study regimen.|||months||95% Confidence Interval|Median
2579376|NCT02416908|Secondary|Time to Neutrophil Engraftment|-Time to neutrophil engraftment: Defined as the date of the first dose of study drug to the date that the absolute neutrophil count is >1,000/mm3|Up to 2 years|-Phase I Schedule A Arm and Phase II Arm data was combined as all participants received the same dose and schedule of the study regimen.|||days||Full Range|Median
2579377|NCT02416908|Secondary|Time to Platelet Engraftment|-Time to platelet engraftment: Defined as the date of the first dose of study drug to the date that the platelet count is >100,000/mm^3 in the absence of platelet transfusions.|56 days|-Phase I Schedule A Arm and Phase II Arm data was combined as all participants received the same dose and schedule of the study regimen.|||days||Full Range|Median
2579378|NCT02416908|Primary|Complete Remission Rate (CR + CRi)|"Morphologic complete remission (CR): neutrophil count > 1.0 x 109 /L, platelet count ≥ 100 x 109/L, < 5% bone marrow blasts by morphologic review, no Auer rods, no evidence of extramedullary disease. (No requirements for marrow cellularity, hemoglobin concentration).~Morphologic complete remission with incomplete blood count recovery (CRi): same as CR but ANC may be <1000/mcl or platelet count <100,000/mcl~Participants in the phase I portion of the study, treated at the MTD will count towards the phase II accrual goal for evaluation of the primary endpoint."|Median follow-up of 34 days|-Phase I Schedule A Arm and Phase II Arm data was combined as all participants received the same dose and schedule of the study regimen.|||Participants|||Count of Participants
2579379|NCT02416908|Primary|Safety and Tolerability of Treatment as Measured by Incidence of Grade 3-4 Adverse Events Occurring in >5% of Participants|-All adverse events will be classified using the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0|From start of treatment until 30 days following last day of study treatment or until the start of a subsequent treatment for AML, whichever came first (41 days)|-Phase I Schedule A Arm and Phase II Arm data was combined as all participants received the same dose and schedule of the study regimen.|||Participants|||Count of Participants
2579380|NCT02416713|Primary|Change in Frequency of Cellphone Unlocks|Change in number of phone unlocks per hour of drive time between intervention period (last 3 weeks) vs. baseline period (last 3 weeks)|6 weeks||||Phone unlocks per hour||95% Confidence Interval|Mean
2579381|NCT02416180|Secondary|Time Taken to Correctly Completing Inhaler Use at Day 14|If a participant made a critical error during the initial assessment, the HCP demonstrated the correct use of the inhaler to the participant and gave verbal instructions. The HCP could have demonstrated the use of the inhaler a maximum of three times. Any errors made after this final demonstration were recorded. The time taken for the HCP to train the participant in the correct technique was recorded as T1: the time from when the participants started their demonstration of MDI use until they had completed their demonstration of MDI use (i.e., with no HCP support), T2: the time from when the HCP started to demonstrate/instruct device use until correct use was demonstrated by the participant (up to a maximum of three attempts only). T3 is defined as T1+T2, which is the time from when the participant started to demonstrate MDI use until correct use was demonstrated by the subject (up to a maximum of three attempts following demonstration by HCP).|Day 14|ITT Population|||Minutes||Full Range|Median
2579708|NCT02413593|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2579382|NCT02416180|Secondary|Number of Health Care Professional (HCP) Instructions Required on Day 14|Participant's inhaler use was assessed on Day 14 by the HCP against a predefined list of critical errors. If a participant made a critical error during this initial assessment, the HCP demonstrated the correct use of the inhaler to the participant and gave verbal instructions. The participant was then asked to demonstrate inhaler use. Any errors were recorded by the HCP. If the participant made a critical error then the HCP repeated the demonstration of inhaler use to the participant for a second time. If the participant continued to make a critical error in the use of the inhaler, the HCP demonstrated the correct use of the inhaler and gave verbal instructions one more time and the participant was then asked to demonstrate inhaler use. Instructions are only given to subjects who make a critical error. Any errors made after this final demonstration were recorded.|Day 14|ITT Population|||Participants|||Number
2579383|NCT02416180|Secondary|Percentage of Participants Making at Least One Overall Error After the First Assessment of MDI Technique on Day 14.|Inhaler use was assessed on Day 14 for overall errors. Overall errors included CEs or N-CEs. Demonstration of usage was with MDI and placebo, CE or N-CEs and even no errors were recorded. CEs were defined as: failure to remove the cap; failure to shake the device; failure to place the device in mouth; no dose actuated during an inhalation manoeuvre; dose coordination that was so poor that the patient was likely to have received no dose or only received minimal dose. N-CEs were defined as: failure to inhale within 5 seconds of shaking the device; no exhalation before an inhalation; the inhalation manoeuvre was not slow and/or was not deep; dose coordination was sub-optimal but patient likely to have received some dose; more than one actuation during an inhalation manoeuvre; did not hold breath. The exact 95% confidence interval is for percent of participants making at least one CE after the first assessment of the MDI technique, and was calculated using exact binomial distribution.|Day 14|ITT population|||Percentage of participants||95% Confidence Interval|Number
2579384|NCT02416180|Primary|Percentage of Participants Making at Least One Critical Error After the First Assessment of Metered Dose Inhaler (MDI) Technique on Day 14|Participant's inhaler use was assessed on Day 14 by the health care professional (HCP) against a predefined list of critical errors (CEs). Critical errors were defined as errors that were most likely to result in no or only minimal medication being inhaled. The participants were asked to demonstrate their usage of the MDI using a placebo demonstration MDI by HCP, critical or non-critical errors (N-CEs) and even no errors made by the participants while using the MDI were recorded. Critical errors in using the MDI were defined as: failure to remove the cap; failure to shake the device; failure to place the device in mouth; no dose actuated during an inhalation manoeuvre; dose coordination that was so poor that the patient was likely to have received no dose or only received minimal dose. 95% confidence interval (CI) is for the % of participants making at least one critical error after the first assessment of the MDI technique, and was calculated using the exact binomial distribution.|Day 14|Intent to Treat (ITT) population: comprised of all participants who were screened and received at least one dose of study medication.|||Percentage of Participants||95% Confidence Interval|Number
2579385|NCT02415959|Other Pre-specified|Treatment Emergent Adverse Events|Treatment emergent adverse events will be summarized per treatment group|From randomization to end of Double Blind period plus 1 day, i.e. up to 7/8 days||||participants|||Number
2579386|NCT02415959|Secondary|Stool Weight|Total amount of stool weight during the collection period in grams|End of the 6 to 7 days double-blind treatment period|Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory).|||gram per 72 hours||Standard Deviation|Mean
2579387|NCT02415959|Secondary|Stool Fat Content|Total amount of fat excreted during the stool collection period in grams.|End of the 6 to 7 days double-blind treatment period|Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory).|||gram per 72 hours||Standard Deviation|Mean
2579388|NCT02415959|Secondary|Coefficient of Nitrogen Absorption (CNA)|CNA is calculated from nitrogen intake and nitrogen excretion, according to the formula: CNA (%) = 100 [nitrogen intake - nitrogen excretion] / nitrogen intake)|End of the 6 to 7 days double-blind treatment period|Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory).|||percentage of nitrogen intake||Standard Deviation|Mean
2579389|NCT02415959|Primary|Coefficient of Fat Absorption (CFA)|CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 [fat intake - fat excretion] / fat intake|End of the 6 to 7 days double-blind treatment period|Full Analysis set. Four randomized subjects excluded because no post-baseline efficacy data (two non-completers and two subjects whose stools were mixed-up with each other at the analytical laboratory).|||percentage of fat intake||Standard Deviation|Mean
2579390|NCT02415842|Secondary|Number of Subjects With Seropositivity Status Against Flu A/Indonesia/05/2005 (H5N1) HI Antibodies - Pediatric H5N1 Cohort|With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1, and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring the number of subjects with seropositivity status against Flu A/Indonesia/05/2005 (H5N1) HI antibodies - Pediatric H5N1 cohort. Seronegative subjects = Subjects with antibody titer < 10 1/DIL for Flu A/Ind/05/05 (H5N1).HA HI prior to vaccination and Seropositive subjects = Subjects with antibody titer ≥ 10 1/DIL for Flu A/Ind/05/05 (H5N1).HA HI prior to vaccination.|At Day 0|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Participants|||Count of Participants
2579403|NCT02415842|Primary|Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL|At D0 (Pre), D21 (Post-dose 1)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579391|NCT02415842|Secondary|Number of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against A/California/7/09 Virus (or Like Virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 Cohorts|With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1, and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring the number of subjects with seropositivity status at pre-vaccination (Baseline) for the HI assay against A/California/7/09 virus (or like virus) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001, Q-PAN-005, H5N1-012 cohorts. Seronegative subjects = Subjects with antibody titer < 10 1/DIL for A/California/7/09 virus (or like virus) and Seropositive subjects = Subjects with antibody titer ≥ 10 1/DIL for A/California/7/09 virus (or like virus).|At Day 0|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Participants|||Count of Participants
2579392|NCT02415842|Secondary|Number of Subjects With Seropositivity Status at Pre-vaccination (Baseline) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 Cohorts|With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1, and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring the number of subjects with seropositivity status at baseline (at Day 0 in all subjects except for group G of Q-PAN-005 [i.e, at Day182]) for the HI assay against the pandemic vaccine homologous virus - Adult FLU D-QIV-015, Q-PAN-005, H5N1-012 cohorts . Seronegative subjects = Subjects with antibody titer < 10 1/DIL for Pandemic vaccine homologous virus and Seropositive subjects = Subjects with antibody titer ≥ 10 1/DIL for Pandemic vaccine homologous virus (i.e., for FLU D-QIV-015: A/Christchurch/16/2010 at Day 0, for Q-PAN-005 study, group C: A/Turkey/01/2005 and A/Indonesia/5/2005 at Day 0 and for group G, A/Turkey/01/2005 at Day 182, for H5N1-012 study, for group VT/VT/12M : A/Vietnam/1194/2004 at Day 0, for group VT/IN/12M, A/Indonesia/5/2005 and A/Vietnam/1194/2004-like at Day 0).|At Day 0, (except for group G of Q-PAN-005, at Day182)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Participants|||Count of Participants
2579393|NCT02415842|Secondary|Number of Subjects With Seropositivity Status at Baseline (Day 0) for the HI Assay Against the Pandemic Vaccine Homologous Virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts|With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1, and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring the number of subjects with seropositivity status at baseline (Day 0) for the HI assay against the pandemic vaccine homologous virus - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 cohorts. Seronegative subjects = Subjects with antibody titer < 10 1/DIL for Pandemic vaccine homologous virus and Seropositive subjects = Subjects with antibody titer ≥ 10 1/DIL for Pandemic vaccine homologous virus (i.e., A/California/7/2009 for subjects from the Q-PAN H1N1-019 study, A/Indonesia/5/2005 for subjects from CC-PAN H5N1-001 study, A/chicken/Hong Kong/G9/1997 for subjects from Q-PAN H9N2-001 study).|At Day 0|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Participants|||Count of Participants
2579394|NCT02415842|Secondary|Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H9N2-001 Cohort|With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts. Percentage of subjects with at least 4-fold increase to anti-H1 stalk ELISA was calculated with 95% CI at each specified time point. seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.|At D21, D42 and D182 (compared to Day 0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579395|NCT02415842|Secondary|Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult CC-PAN H5N1-001 Cohort|With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts. Percentage of subjects with at least 4-fold increase to anti-H1 stalk ELISA was calculated with 95% CI at each specified time point. seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.|At D21, D42, D182 and Day 385 (compared to Day 0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579404|NCT02415842|Primary|Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579709|NCT02413593|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
2579396|NCT02415842|Secondary|Percentage of Subjects With at Least 4-fold Increase of Anti-H1 Stalk ELISA - Adult Q-PAN H1N1-019 Cohort|With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts. Percentage of subjects with at least 4-fold increase to anti-H1 stalk ELISA was calculated with 95% CI at each specified time point. seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.|At D21, D42, and D182 (compared to Day 0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579397|NCT02415842|Secondary|GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H9N2-001 Cohort|With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts. Geometric mean concentration (AS Group and no AS group within each study) was calculated with 95% CI at each specified time point and expressed in Elisa Unit per milliliter (EU/mL).|At D21, D42 and D182|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||EU/mL||95% Confidence Interval|Geometric Mean
2579398|NCT02415842|Secondary|GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult CC-PAN H5N1-001 Cohort|With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts. Geometric mean concentration (AS Group and no AS group within each study) was calculated with 95% CI at each specified time point and expressed in Elisa Unit per milliliter (EU/mL).|At D21, D42, D182 and Day 385|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||EU/mL||95% Confidence Interval|Geometric Mean
2579399|NCT02415842|Secondary|GMCs of Anti-H1 HA Stalk ELISA Antibody - Adult Q-PAN H1N1-019 Cohort|With respect to samples from the HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and IIV4 seasonal, influenza vaccines), analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all the subjects in the adult CCPan H5N1-001, the Q-Pan H1N1-019 and the Q-Pan H9N2-001 study cohorts. Geometric mean concentration (AS Group and no AS group within each study) was calculated with 95% CI at each specified time point and expressed in Elisa Unit per milliliter (EU/mL).|At D21, D42, and D182|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||EU/mL||95% Confidence Interval|Geometric Mean
2579400|NCT02415842|Primary|Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At D21 (post-dose1) compared to D0|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579401|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.|At D21 (post-dose1 compared to [/]D0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579402|NCT02415842|Primary|H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|At D0 (Pre), D21 (Post-dose 1)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2579622|NCT02414854|Secondary|Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population|FEF is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF25-75% is defined as the mean forced expiratory flow between the 25% and 75% of the FVC.|Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52|Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.|||liters/sec||Standard Deviation|Mean
2607397|NCT02090426|Secondary|Inpatient Readmission Not From the ED||180-day from indexed hospital discharge||2021-01-31|01/2021||||
2579405|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.|At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579406|NCT02415842|Primary|H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2579407|NCT02415842|Primary|Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL|At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579408|NCT02415842|Primary|Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2) and D591 (ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2) and D591 (ps-d3) compared to D182 for Group G|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579409|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.|For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579410|NCT02415842|Primary|H1N1pdm09-like Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2579418|NCT02415842|Primary|H1N1pdm09-like Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2607398|NCT02090426|Secondary|Inpatient Readmission From the ED||180-day from indexed hospital discharge||2021-01-31|01/2021||||
2579411|NCT02415842|Primary|Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.|Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579412|NCT02415842|Primary|Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At Day 42 (post-vaccination2/ pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579413|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.|At Day 42 (post-vaccination2 compared to pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579414|NCT02415842|Primary|H1N1pdm09-like Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2579415|NCT02415842|Primary|Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.|At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies|||Percentage of subjects||95% Confidence Interval|Number
2579416|NCT02415842|Primary|Mean Geometric Increase (MGI) for H1N1pdm09-like Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At Day 42 (post-vaccination2/ pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies|||Ratio||95% Confidence Interval|Geometric Mean
2579417|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for H1N1pdm09-like Flu Virus Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for H1N1pdm09-like Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.|At Day 42 (post-vaccination2 compared to pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579419|NCT02415842|Primary|Percentage of Subjects With H1N1pdm09-like Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1pdm09-like Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution).|At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579420|NCT02415842|Primary|Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At D21 (post-dose1) compared to D0|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579421|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.|At D21 (post-dose1 compared to [/]D0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579422|NCT02415842|Primary|H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|At D0 (Pre), D21 (Post-dose 1)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2579423|NCT02415842|Primary|Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.|At D0 (Pre), D21 (Post-dose 1)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579424|NCT02415842|Primary|Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579425|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.|At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579829|NCT02413047|Secondary|Improvement or Normalization of Mayo Endoscopy Score for UC Patients|Mayo endoscopy score is scoring completed during the endoscopy to evaluate disease activity. Scoring is based on stool frequency, rectal bleeding, mucosal appearance at endoscopy, and physician rating of disease activity|4 months|Not enough subjects for analysis||||||
2579426|NCT02415842|Primary|H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2579427|NCT02415842|Primary|Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.|At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579428|NCT02415842|Primary|Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2) and D591 (ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2) and D591 (ps-d3) compared to D182 for Group G|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579429|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.|For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579430|NCT02415842|Primary|H1N1 Swine Flu Virus Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2579431|NCT02415842|Primary|Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.|Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579432|NCT02415842|Primary|Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At Day 42 (post-vaccination2/ pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579846|NCT02413008|Secondary|Changes in Vaginal pH Between Baseline and Week 3 and Week 12|Measurement of vaginal pH on the vaginal secretion using a reactive strip and compare pH value between baseline and the diferent timepoints|week 3 and week 12 vs baseline|postmenopausal women|||units on a scale||Inter-Quartile Range|Mean
2579433|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer|At Day 42 (post-vaccination2 compared to pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579434|NCT02415842|Primary|H1N1 Swine Flu Virus Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2579435|NCT02415842|Primary|Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.|At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579436|NCT02415842|Primary|Mean Geometric Increase (MGI) for H1N1 Swine Flu Virus Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At Day 42 (post-vaccination2/ pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579437|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for H1N1 Swine Flu Virus Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for H1N1 swine Flu virus MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.|At Day 42 (post-vaccination2 compared to pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579438|NCT02415842|Primary|H1N1 Swine Flu Virus Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2579439|NCT02415842|Primary|Percentage of Subjects With H1N1 Swine Flu Virus Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of H1N1 swine Flu virus antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution ).|At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579847|NCT02413008|Secondary|Variation in Plasma Levels of Estrona|Change in plasma levels of estrona at weeks 1, 3, 8 and 12 compared to baseline.|Change from baseline to week 1, week 3, week 8 and week 12|postmenopausal women|||pg/mL||Inter-Quartile Range|Median
2579440|NCT02415842|Primary|Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At D21 (post-dose1 compared to D0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579441|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.|At D21 (post-dose1 compared to [/]D0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579442|NCT02415842|Primary|RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|At D0 (Pre), D21 (Post-dose 1)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2579443|NCT02415842|Primary|Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL.|At D0 (Pre), D21 (Post-dose 1)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579444|NCT02415842|Primary|Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At D21 (post-dose[ps-d]1), M12 (ps-d1) and M12+21days (ps-d2) compared to D0|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579445|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.|At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579446|NCT02415842|Primary|RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2579627|NCT02414854|Secondary|Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Weeks 2, 4, 8, 24, 36, and 52|Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.|||liter||Standard Deviation|Mean
2579447|NCT02415842|Primary|Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL|At D0 (Pre), D21 (Post-dose 1) and M12+21days (post-dose2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579448|NCT02415842|Primary|Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2) and D591 (ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2) and D591 (ps-d3) compared to D182 for Group G|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579449|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.|For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579450|NCT02415842|Primary|RG Reassortant Virus (H5N8) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2579451|NCT02415842|Primary|Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL|Group C: At D0 (Pre), D42 (Post-dose 1), D549 (post-dose 2) and D591 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2) and D591 (Post-dose 3)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579452|NCT02415842|Primary|Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At Day 42 (post-vaccination2/ pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579460|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.|At D21 (post-dose1) compared to D0|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579453|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.|At Day 42 (post-vaccination2 compared to pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579454|NCT02415842|Primary|RG Reassortant Virus (H5N8) Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2579455|NCT02415842|Primary|Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.|At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579456|NCT02415842|Primary|Mean Geometric Increase (MGI) for RG Reassortant Virus (H5N8) Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At Day 42 (post-vaccination2/ pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579457|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for RG Reassortant Virus (H5N8) Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. seropositive subjects = titer ≥ 10 1/DIL for RG reassortant virus (H5N8) MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.|At Day 42 (post-vaccination2 compared to pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579458|NCT02415842|Primary|RG Reassortant Virus (H5N8) Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2579459|NCT02415842|Primary|Percentage of Subjects With RG Reassortant Virus (H5N8) Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of RG reassortant virus (H5N8) antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution )|At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2598853|NCT02181127|Secondary|Number of Hypoglycemic Episodes With CGMG < 70 mg/dl||from t=0 to study stop after 2 weeks||||number of episodes||Standard Deviation|Mean
2579461|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration < 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.|At D21 (post-dose1 compared to [/]D0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579462|NCT02415842|Primary|Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)|At D0 (Pre), D21 (Post-dose 1)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||EU/mL||95% Confidence Interval|Geometric Mean
2579463|NCT02415842|Primary|Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)|At D0 (Pre), D21 (Post-dose 1)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579464|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.|At D21 (post-dose[ps-d]1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579465|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration < 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.|At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579466|NCT02415842|Primary|Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)|At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||EU/mL||95% Confidence Interval|Geometric Mean
2579503|NCT02415842|Primary|Anti-H1 Stalk Antibody Titers (by MN) - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|At D0 (Pre), D21 (Post-dose 1)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2607399|NCT02090426|Secondary|Any Hospital Use (Inpatient or ED)||180-day from indexed hospital discharge||2021-01-31|01/2021||||
2579467|NCT02415842|Primary|Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)|At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579468|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.|At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579469|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration < 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.|For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579470|NCT02415842|Primary|Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)|At D0(Pre), D42 (Post-dose[Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||EU/mL||95% Confidence Interval|Geometric Mean
2579471|NCT02415842|Primary|Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)|At D0(Pre), D42 (Post-dose[Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579472|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.|At Day 42 (post-vaccination2/ Day 0) and final time point (for persistence)(i.e., Day 385(post-vaccination2/ Day 0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579628|NCT02414854|Secondary|Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|Analysis was performed on ITT population with baseline eosinophil >=0.15 Giga/L. 'Overall number of participants analyzed'=participants evaluable for this outcome measure at specified timepoint.|||percent change||Standard Deviation|Mean
2579473|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohortand for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration < 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.|At Day 42 (post-vaccination2 compared to Day 0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579474|NCT02415842|Primary|Anti-H18 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)|At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||EU/mL||95% Confidence Interval|Geometric Mean
2579475|NCT02415842|Primary|Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Pediatric Q-PAN H5N1-AS03-021 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)|At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579476|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H18 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.|At Day 42 (post-vaccination2/ Day 0), and final timepoint (for persistence) compared to Day 0 (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579477|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H18 Full Length HA ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration < 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H18 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.|At Day 42 (post-vaccination2 compared to pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579478|NCT02415842|Primary|Anti-H18 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)|At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||EU/mL||95% Confidence Interval|Geometric Mean
2579629|NCT02414854|Secondary|Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|Analysis was performed on ITT population with high dose ICS at baseline. 'Overall number of participants analysed'=participants evaluable for this outcome measure at specified timepoint.|||percent change||Standard Deviation|Mean
2579479|NCT02415842|Primary|Percentage of Subjects With Anti-H18 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H18 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)|At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579480|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.|At D21 (post-dose1) compared to D0|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579481|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration < 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.|At D21 (post-dose1 compared to [/]D0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579482|NCT02415842|Primary|Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)|At D0 (Pre), D21 (Post-dose 1)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||EU/mL||95% Confidence Interval|Geometric Mean
2579483|NCT02415842|Primary|Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)|At D0 (Pre), D21 (Post-dose 1)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579484|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.|At D21 (post-dose[ps-d]1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579504|NCT02415842|Primary|Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL|At D0 (Pre), D21 (Post-dose 1)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2598854|NCT02181127|Secondary|Number of Hypoglycemic Episodes With CGMG < 60 mg/dl||from t=0 to study stop after 2 weeks||||number of episodes||Standard Deviation|Mean
2579485|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration < 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.|At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579486|NCT02415842|Primary|Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)|At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||EU/mL||95% Confidence Interval|Geometric Mean
2579487|NCT02415842|Primary|Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)|At D0 (Pre), D21 (Post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579488|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.|At Day[D] 42 (post-dose[ps-d]1), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579489|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration < 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.|For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579490|NCT02415842|Primary|Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)|At D0(Pre), D42(Post-dose [Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||EU/mL||95% Confidence Interval|Geometric Mean
2579653|NCT02414828|Primary|Forced Expiratory Volume in One Second (FEV1)|Maximum number of subjects with deterioration >10% from baseline, at any time point. in forced expiratory volume in one second (FEV1)|182 days|Subjects who were evaluated.|||participants|||Number
2607400|NCT02090426|Secondary|Any Emergency Department Use||180-day from indexed hospital discharge||2021-01-31|01/2021||||
2579491|NCT02415842|Primary|Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)|At D0(Pre), D42(Post-dose [Pst-d]1), D182(Pst-d1), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group C, and D182(Pst-d1), D224(Pst-d2), D549(Pst-d2), D591(Pst-d3) and D729(Pst-d3) for group G|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579492|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.|At Day 42 (post-vaccination2/ Day 0) and final time point (for persistence)(i.e., Day 385[post-vaccination2]/ Day 0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579493|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohortand for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration < 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.|At Day 42 (post-vaccination2 compared to Day 0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579494|NCT02415842|Primary|Anti-H2 Full Length HA ELISA Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)|At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||EU/mL||95% Confidence Interval|Geometric Mean
2579495|NCT02415842|Primary|Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Pediatric Q-PAN H5N1-AS03-021 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)|At Day 42 (Post-vaccination 2) and final timepoint (for persistence) (i.e., Day 385)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579496|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H2 Full Length HA ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.|At Day 42 (post-vaccination2/ Day 0), and final timepoint (for persistence) compared to Day 0 (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579623|NCT02414854|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population|FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters.|Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52|Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.|||liter||Standard Deviation|Mean
2598855|NCT02181127|Secondary|Number of Hypoglycemic Episodes With CGMG < 50 mg/dl||From t=0 to study stop after 2 weeks||||number of episodes||Standard Deviation|Mean
2579497|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H2 Full Length HA ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration < 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. seropositive subjects = concentration ≥ 50 EU/mL for anti-H2 HA (full length) antibody prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 100 EU/mL at post-vaccination; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.|At Day 42 (post-vaccination2 compared to pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579498|NCT02415842|Primary|Anti-H2 Full Length HA ELISA Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)|At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||EU/mL||95% Confidence Interval|Geometric Mean
2579499|NCT02415842|Primary|Percentage of Subjects With Anti-H2 Full Length HA ELISA Antibody Concentration Equal or Above the Cut-off of 50 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H2 antibody by ELISA for the subjects who received an AS vaccine in each study cohort and for the subjects in the FLU D-QIV-015 study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 50 Elisa Unit per milliliter (EU/mL)|At Day 42 (Post-vaccination 2), and final timepoint (for persistence) (i.e., Day 182 for the Q-Pan-H1N1-019, Q-PAN-H9N2-001 and Day 385 for the CC-Pan-H5N1 study cohorts)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579500|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At D21 (post-dose1) compared to D0|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579501|NCT02415842|Primary|Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer.|At D21 (post-dose1 compared to [/]D0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579502|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.|At D21 (post-dose1 compared to [/]D0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579624|NCT02414854|Secondary|Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population|The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma.|Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52|Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.|||liters/min||Standard Deviation|Mean
2579505|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At D21 (post-dose[ps-d]1), M6 (ps-d1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579506|NCT02415842|Primary|Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.|At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579507|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.|At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579508|NCT02415842|Primary|Anti-H1 Stalk Antibody Titers (by MN) - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2579509|NCT02415842|Primary|Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL|At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579510|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At Day[D] 42 (post-dose[ps-d]1), D182 (ps-d1), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579523|NCT02415842|Primary|Anti-H1 Stalk Antibody Titers (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2598856|NCT02181127|Secondary|Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime||2 weeks||||percentage of time||Standard Deviation|Mean
2579511|NCT02415842|Primary|Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer. The ≥10-fold increases were only calculated relative to baseline.|For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579512|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer. The ≥4-fold increases were only calculated relative to baseline.|For group C: At Day 42 (post-dose1 compared to [/]Day 0), at Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579513|NCT02415842|Primary|Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|Group C: At D0 (Pre), D42 (Post-dose 1), D182 (post-dose 1), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2579514|NCT02415842|Primary|Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/DIL|Group C: At D0 (Pre), D42 (Post-dose 1), D182 (post-dose 1), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3); Group G: At D182 (Post-dose 1), D224 (Post-dose 2), D549 (post-dose 2), D591 (Post-dose 3) and D729 (Post-dose 3)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579515|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579516|NCT02415842|Primary|Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer.|At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579848|NCT02413008|Secondary|Variation in Plasma Levels of Estradiol|Change in plasma levels of estradiol at weeks 1, 3, 8 and 12 compared to baseline.|Change from baseline to week 1, week 3, week 8 and week 12|postmenopausal women|||pg/mL||Inter-Quartile Range|Median
2579517|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.|At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579518|NCT02415842|Primary|Anti-H1 Stalk Antibody Titers (by MN) -Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, Geometric mean titers (GMTs) were calculated with 95% CI for each treatment group within each study cohort.|At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Titer||95% Confidence Interval|Geometric Mean
2579519|NCT02415842|Primary|Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Pediatric Q-PAN H5N1-AS03-021 Cohort (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titerss greater or equal than 10 1/DIL.|At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579520|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H1 Stalk Antibody Post-vaccination Concentration Compared to Pre-vaccination, by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMT over pre-vaccination GMT.|At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination), Day 182 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination - for H5N1 cohorts only )|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579521|NCT02415842|Primary|Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk Antibody Titer (by MN) - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 10-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 50 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 10-fold the pre-vaccination antibody titer.|At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579522|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk Antibody Titer by MN - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by MN for all subjects who received an AS vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = titer < 10 1/DIL for anti-H1 stalk MN prior to vaccination seropositive subjects = titer ≥ 10 1/DIL for anti-H1 stalk MN prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody titer ≥ 20 1/DIL at post-vaccination; For initially seropositive subjects, antibody titer at post-vaccination ≥ 4-fold the pre-vaccination antibody titer.|At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579593|NCT02415166|Primary|THE TITER OF INFLUENZA ANTIBODIES|"Outcome data were not collected.~This was a failed study as all participants, including those who were putatively vaccine-naive had antibodies to influenza at baseline and therefore the original hypothesis could not be tested. The study was terminated."|ONE MONTH|Unmedicated outpatients with major depressive disorder. Outcome data not collected.||||||
2607401|NCT02090426|Primary|Any Hospital Readmission||180-day from indexed hospital discharge||||Participants|||Count of Participants
2579524|NCT02415842|Primary|Percentage of Subjects With Anti-H1 Stalk Antibody Titer (by MN) Equal or Above the Cut-off of 10 1/DIL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts (Only AS Vaccines)|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by microneutralization (MN) for all subjects who received an adjuvant system (AS) vaccine in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with titers greater or equal than 10 1/Dilution (1/DIL).|At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579525|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.|At D21 (post-dose1) compared to D0|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579526|NCT02415842|Primary|Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration.|At D21 (post-dose1 compared to [/]D0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579527|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.|At D21 (post-dose1 compared to [/]D0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579528|NCT02415842|Primary|Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)|At D0 (Pre), D21 (Post-dose 1)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||EU/mL||95% Confidence Interval|Geometric Mean
2579529|NCT02415842|Primary|Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult FLU D-QIV-015 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL)|At D0 (Pre), D21 (Post-dose 1)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579530|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.|At D21 (post-dose[ps-d]1), M6 (ps-d1), M12 (ps-d1), M12+21days (ps-d2) and M18 compared to D0|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2581817|NCT02388568|Secondary|Body Weight (% Change)|This is the change in weight from the baseline (screening visit) to the final week 52 medical assessment visit.|-14 week (start of LCD program) to week 52||||% change||Standard Error|Mean
2579531|NCT02415842|Primary|Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration. The ≥10-fold increases were only calculated relative to baseline.|At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579532|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.|At D21 (post-dose1 compared to [/]D0), at M12+21days (post-dose2 /D0)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579533|NCT02415842|Primary|Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)|At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||EU/mL||95% Confidence Interval|Geometric Mean
2579534|NCT02415842|Primary|Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult H5N1-012 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL)|At D0 (Pre), D21 (Post-dose 1), Month (M)6 (post-dose 1), M12 (Post-dose1), M12+21days (post-dose2), M18 (Post-dose2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579535|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.|At Day[D] 42 (post-dose[ps-d]1), D182 (ps-d1), D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D0 for Group C and at D224 (ps-d2), D549 (ps-d2), D591 (ps-d3) and D729(ps-d3) compared to D182 for Group G|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579536|NCT02415842|Primary|Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration. The ≥10-fold increases were only calculated relative to baseline.|For group C: At Day 42 (post-dose1 compared to [/]Day 0), Day 224 (post-dose 2/Day 0), Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182), at Day 591 (post-dose3 / Day 182)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579710|NCT02413593|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2579537|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration. The ≥4-fold increases were only calculated relative to baseline.|For group C: At Day 42 (post-dose1 compared to [/]Day 0), Day 224 (post-dose 2/Day 0), Day 591 (post-dose3 / Day 0) - For group G: At Day 224 (post-dose2 / Day 182); at Day 591 (post-dose3 / Day 182)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579538|NCT02415842|Primary|Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL).|At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 1), Day 182 (post-vaccination 1), Day 224 (Post-vaccination 2), Day 549 (post-vaccination 2), Day 591 (Post-vaccination 3) and Day 729 (Post-vaccination 3)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||EU/mL||95% Confidence Interval|Geometric Mean
2579539|NCT02415842|Primary|Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN-005 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL).|At Day 0 (Pre-vaccination), Day 42 (Post-vaccination 1), Day 182 (post-vaccination 1), Day 224 (Post-vaccination 2), Day 549 (post-vaccination 2), Day 591 (Post-vaccination 3) and Day 729 (Post-vaccination 3)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579540|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination -Pediatric Q-PAN H5N1-AS03-021 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.|At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579541|NCT02415842|Primary|Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration.|At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579542|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Pediatric Q-PAN H5N1-AS03-021 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.|At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579849|NCT02413008|Secondary|Variation in Plasma Levels of Estriol|Change in plasma levels of estriol at weeks 1, 3, 8 and 12 compared to baseline|Change from baseline to week 1, week 3, week 8 and week 12|postmenopausal women|||pg/mL||Inter-Quartile Range|Median
2579543|NCT02415842|Primary|Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations -Pediatric Q-PAN H5N1-AS03-021 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL).|At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||EU/mL||95% Confidence Interval|Geometric Mean
2579544|NCT02415842|Primary|Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Pediatric Q-PAN H5N1-AS03-021 Cohort|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL)|At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2) and Day 385 (Post-vaccination 2)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579545|NCT02415842|Primary|Mean Geometric Increase (MGI) for Anti-H1 Stalk ELISA Antibody Post-vaccination Concentration Compared to Pre-vaccination - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Mean Geometric Increase (MGI) = post-vaccination GMC over pre-vaccination GMC.|At Day 21 (post-vaccination1/ pre-vaccination), Day 42 (post-vaccination2/ pre-vaccination), Day 182 (post-vaccination2/ pre-vaccination) and Day 385(post-vaccination2/ pre-vaccination - for H5N1 cohorts only )|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Ratio||95% Confidence Interval|Geometric Mean
2579546|NCT02415842|Primary|Percentage of Subjects With a ≥10-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination 10-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 330 EU/mL at post-vaccination, For initially seropositive subjects, antibody concentration at post-vaccination ≥ 10-fold the pre-vaccination antibody concentration.|At Day 21 (post-vaccination1 compared to pre-vaccination), Day 42 (post-vaccination2 compared to pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579547|NCT02415842|Primary|Percentage of Subjects With a ≥4-fold Rise for Anti-H1 Stalk ELISA Antibody Concentration - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seronegative subjects = concentration < 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. Seropositive subjects = concentration ≥ 66 EU/mL for anti-H1 stalk ELISA prior to vaccination. 4-fold increase defined as: For initially seronegative subjects, antibody concentration ≥ 132 EU/mL at post-vaccination. For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4-fold the pre-vaccination antibody concentration.|At Day 21 (post-vaccination 1 compared to pre-vaccination), Day 42 (post-vaccination 2 compared to pre-vaccination)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579548|NCT02415842|Primary|Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentrations - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts|With respect to samples from HA Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Geometric mean concentrations (GMCs) were expressed in Elisa Unit per milliliter (EU/mL)|At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||EU/mL||95% Confidence Interval|Geometric Mean
2579625|NCT02414854|Secondary|Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52|Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.|||percent predicted of FEV1||Standard Deviation|Mean
2580253|NCT02408263|Secondary|Nausea|Nausea was assessed by patients' self-report on their level of nausea on a 0-3 scale: 0=No nausea; 1=Mild nausea; 2=Moderate nausea; 3=Severe nausea.|Baseline, Postoperative day 1, Postoperative day 2||||units on a scale||Standard Deviation|Mean
2579549|NCT02415842|Primary|Percentage of Subjects With Anti-H1 Stalk Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Equal or Above the Cut-off of 66 EU/mL - Adult Q-PAN H1N1-019, CC-PAN H5N1-001, Q-PAN H9N2-001 Cohorts|With respect to samples from Hemagglutinin (HA) Group 1-related studies (i.e., with H1N1, H5N1,and H9N2 pandemic, and quadrivalent inactivated seasonal, influenza vaccines, analysis was performed for measuring levels of anti-H1 stalk antibody by ELISA for all subjects in each study cohort, aggregate variables were calculated with 95% CI for each treatment group within each study cohort. Seropositivity rate was defined as the percentage of subjects with concentrations greater or equal than 66 Elisa Unit per milliliter (EU/mL).|At Day 0 (Pre-vaccination), Day 21 (Post-vaccination 1), Day 42 (Post-vaccination 2), Day 182 (post-vaccination 2) and Day 385 (Post-vaccination 2 -for H5N1 cohorts only)|All subjects from each study cohort with available results were included in the analysis for this study. All subjects selected were from the ATP cohort for immunogenicity of respective primary studies.|||Percentage of subjects||95% Confidence Interval|Number
2579550|NCT02415608|Secondary|Overall Survival (OS)|Overall survival (OS) was assessed through 2 years of treatment, and recorded as the time from the start of treatment to either progression or death, with values censored at the last response assessment if the participant did not progress or die during that period. OS is reported as reported as the median with standard deviation.|26 months|The single patient receiving ibrutinib 560 mg/day was censored per protocol.|||months||95% Confidence Interval|Mean
2579551|NCT02415608|Secondary|Progression-free Survival (PFS)|Participants were assessed for progression-free survival (PFS) from the start of treatment through 2 years of treatment. The outcome is reported as the number of participants who were alive without disease progression after 2 years of treatment.|2 years|Results were analyzed for all participants. Values were censored at the last assessment if the participant was lost-to-follow-up or otherwise did not have a 2-year assessment.|||Participants|||Count of Participants
2579552|NCT02415608|Secondary|Time-to-Response (TTR)|Time-to-response (TTR) was assessed through 2 years of treatment, and reported as the median with standard deviation, censored at last response assessment in the event of death or progression not documented.|2 years|No participants achieved clinical response per protocol (minimum of any clinical improvement ≥ 12 weeks). On that basis, the time to achieve per-protocol clinical response can not be determined.||||||
2579553|NCT02415608|Secondary|Duration of Response (DoR)|Duration of response (DoR) was assessed through 2 years of treatment, and reported as the median with standard deviation, with response duration censored at last response assessment in the event of death or progression not documented.|2 years|No participants achieved clinical response per protocol (minimum of any clinical improvement ≥ 12 weeks). On that basis, the overall duration of that response can not be determined.||||||
2579554|NCT02415608|Secondary|Change in Quality of Life (QoL)|The quality of life (QoL) component of the Myeloproliferative Neoplasm Symptom Assessment Form (MPNSAF) modified for mast cell symptoms, a scale of life quality ranking from 0 (best) to 10 (worst), was assessed at baseline and after 1 cycle of ibrutinib treatment (30 days), and reported as the median change in score with standard deviation.|30 days|Results were analyzed for all participants.|||score on a scale||Standard Deviation|Median
2579555|NCT02415608|Secondary|Total Symptom Score (TSS)|The totality of systemic mastocytosis was assessed by the total symptom score as measured by a Myeloproliferative Neoplasm Symptom Assessment Form modified for mast cell disorders [MPN-SAF (MCD)], and reported as the change in median score with standard deviation at baseline and 30 days. The MPN-SAF is a single, 27-question questionnaire that scores the following general measures on a scale of 0 (best) to 10 (worst): fatigue levels, effects of fatigue, satiety, pain, activity, concentration, dizziness, sleep, mood, anxiety, sexual function, itching, flushing, fever, weight loss, respiratory functions, diarrhea, lesions, and allergic reactions (some of these general terms may describe more than 1 assessment). The score on the MPN-SAF is the sum total of all 27 scores, and the range of scores is from a minimum of 0 (best; symptoms for all assessment absent) to a maximum of 270 (worst; score of 10 on all assessments).|30 days|Results were analyzed for all participants.|||score on a scale||Standard Deviation|Median
2579556|NCT02415608|Secondary|Serum Tryptase Levels|Serum tryptase level is a surrogate marker for the desired histopathologic response, ie, reduction in mast cell burden. Serum tryptase levels are reported as the median of the percent reduction, with full range, from baseline up to 2 years.|2 years|Results were determined for all participants.|||Percent reduction serum tryptase level||Full Range|Median
2579557|NCT02415608|Secondary|Change of Mast Cell Burden|The change in the number of neoplastic mast cells in tissues (blood and/or bone marrow), ie, a measure of mast cell burden, will be assessed by immunophenotyping and/or immunohistochemistry (depending on patient and disease specifics) using mast cell markers, eg, CD25, CD30, CD117, tryptase, reticulin, Wright-Giemsa staining, and/or hematoxylin-eosin staining, in peripheral blood smears or bone marrow samples. For each participant, the data are used to collectively determine a single assessment for the number of mast cells present at baseline and after treatment. The outcome is reported as the median change in that level of mast cells, with full range, from baseline up to 2 years.|2 years|The result was only calculated for those participants for whom a post-treatment mast cell level could be determined.|||Percent reduction of mast cells||Full Range|Median
2579558|NCT02415608|Secondary|Ibrutinib Pharmacokinetics (PK)|Plasma concentration-time profiles for each subject and mean plasma concentration-time profiles for each dose level will be plotted, plasma concentration data for ibrutinib at each time point will be summarized by descriptive statistics, and PK parameters such as maximum concentration (Cmax), minimum concentration, time at which the Cmax is reached, and area under the curve will be summarized with mean, geometric mean, medium, minimum, maximum, standard deviation, and coefficient of variation.|28 days|Because this study terminated with low total accrual, the funding sponsor elected not to analyze the samples for ibrutinib levels. There are no pharmacokinetics values on which to conduct the outcome analysis.||||||
2579559|NCT02415608|Secondary|Number of Participants With Adverse Events|Adverse events will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, and reported as the number and percentage of participants having any adverse event; by each grade of adverse event; and by affected body systems.|30 days|All study participants are included in this analysis.|||Participants|||Count of Participants
2580254|NCT02408263|Primary|Skin Conductance Response|A skin conductance response is defined as a minimum followed by a maximum in conductance values micro Siemens (mS).|Baseline, Postoperative day 1, Postoperative day 2||||micro Siemens (mS)||Standard Deviation|Mean
2579560|NCT02415608|Primary|Overall Response Rate (ORR)|"Overall response rate (ORR) is reported as the sum of the rates of participants achieving complete remission (CR), partial remission (PR), & clinical improvement (CI). A clinical response is a response with duration of ≥ 12 weeks.~CR is defined as all 4 criteria:~No presence of compact neoplastic mast cell aggregates~Serum tryptase level < 20 ng/mL~Peripheral blood count remission defined as absolute neutrophil count (ANC) ≥1 x 10e9/L + normal differential, Hb ≥11 g/dL, & platelet count ≥100x10e9/L~Complete resolution of palpable hepatosplenomegaly & all biopsy-proven or suspected SM-related organ damage~PR is defined as all 3 criteria with response duration ≥12 weeks, that is not CR or progressive disease:~≥ 50% reduction in neoplastic mast cells~Serum tryptase level reduced ≥50%~Resolution of 1+ biopsy-proven or suspected systemic mastocytosis (SM)-related organ damage findings~CI is defined as any improvement in any of the above measures."|Up to 6 months||||Participants|||Count of Participants
2579561|NCT02415595|Secondary|Area Under the Concentration-time Curve in One Dosing Interval (AUC [Tau]) of BMS-955176/GSK3532795|Serial blood samples were collected at indicated time points for intensive PK assessment.|Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)|Evaluable PK Population|||Hour*nanogram/ milliliter||Geometric Coefficient of Variation|Geometric Mean
2579562|NCT02415595|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of BMS-955176/GSK3532795|Serial blood samples were collected at indicated time points for intensive PK assessment.|Pre-dose (morning) and 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)|Evaluable PK Population|||Hour||Full Range|Median
2579563|NCT02415595|Secondary|Maximum Observed Plasma Concentration (Cmax), Observed Pre-dose Plasma Concentration (C0) and Observed Plasma Concentration at the End of a Dosing Interval (Ctau) of BMS-955176/GSK3532795|Serial blood samples were collected at indicated time points for intensive pharmacokinetic (PK) assessment. The PK assessments were performed on evaluable PK Population, a sub-population which included all treated participants who had adequate PK profiles.|Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)|Evaluable PK Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2579564|NCT02415595|Secondary|Number of Participants With at Least One Centers for Disease Control (CDC) Class C Events|The occurrence of new AIDS defining events that is CDC class C events is presented.|Up to Week 96|mITT Population|||Participants|||Count of Participants
2579565|NCT02415595|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation (AELD)|Any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE. Number of participants with SAEs and AELDs is summarized.|Up to Week 96|mITT Population|||Participants|||Count of Participants
2579566|NCT02415595|Secondary|Change From Baseline in the Percentage of CD4+ T-cells Over Time|CD4+ T-cell counts overall was assessed using flow cytometry. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in percentage of CD4+T- cell counts is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.|Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|mITT Population (observed)|||Percentage of CD4+T- cells||Standard Deviation|Mean
2579567|NCT02415595|Secondary|Change From Baseline in Cluster of Differentiation (CD)4+ Thymus (T)-Cell Counts Over Time|CD4+ T-cell counts was assessed using flow cytometry. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in CD4+T- cell counts is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.|Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|mITT Population (observed)|||Cells per microliter||Standard Deviation|Mean
2579568|NCT02415595|Secondary|Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time|Blood samples were collected for analysis of HIV-1 RNA. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in plasma HIV-1 RNA (log10) is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.|Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|mITT Population (observed)|||Log 10 c/mL||Standard Deviation|Mean
2579594|NCT02415127|Secondary|Change From Baseline to Week 26 in Total Friedreich Ataxia Rating Scale Score (FARStot)|The FARS assessment includes neurological signs that specifically reflect neural substrates affected in FA. Based on a neurological examination, bulbar, upper limb, lower limb, peripheral nerve, and upright stability/gait functions are assessed. FARStot scores range from 0 (normal) to 125 (most impairment). A negative change from baseline indicates improvement.|Baseline, Week 26|ITT Population: All randomized participants with a valid baseline (including Screening) and at least 1 valid post baseline measurement in the primary efficacy outcome (FARS-mNeuro) and FARStot data at Baseline and Week 26. A valid FARS-mNeuro score was defined as no missing values in the questionnaire.|||units on a scale||Standard Deviation|Mean
2579569|NCT02415595|Secondary|Number of Participants With Newly Emergent Phenotypic Resistance Using All On-treatment Isolates|Phenotypic resistance to a drug is defined as a fold change (i.e., ratio of the 50% inhibitory concentration (IC50) of the clinical isolate to the IC50 of the reference strain) which is greater than the cut-off for reduced susceptibility. Emergent phenotypic resistance to BMS-955176/GSK3532795 was defined as a Baseline fold change IC50<= 3 and an on-treatment fold change IC50>3. The number of participants with newly emergent phenotypic resistance is presented for participants in the mITT Population who had Baseline and on-treatment phenotypic resistance testing. The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 24 as the study was terminated early.|Week 24|mITT Population. Only participants who had Baseline and on-treatment phenotypic resistance testing were analyzed.|||Participants|||Count of Participants
2579570|NCT02415595|Secondary|Number of Participants With Newly Emergent Genotypic Resistance Using All On-treatment Isolates|The emergence of genotypic resistance among samples selected for drug resistance testing were assessed by searching for all reverse transcriptase substitutions and protease inhibitor substitutions listed in the International Acquired Immunodeficiency Syndrome (AIDS) Society-United States of America (IAS-USA) list of HIV-1 drug resistance mutations. The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 24 as the study was terminated early. The emergence of genotypic resistance is presented for participants in the mITT Population who had Baseline and on-treatment genotypic resistance testing and who had successful sequencing.|Week 24|mITT Population. Only participants with Baseline and on-treatment genotypic resistance testing and who had successful sequencing were analyzed.|||Participants|||Count of Participants
2579571|NCT02415595|Secondary|Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Weeks 48 and 96|Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV-1 RNA <200 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. The analysis was performed using mITT Population (observed), which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). The data was not collected for Week 96 analysis; as the study was terminated early. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|Weeks 48 and 96|mITT Population (observed)|||Participants|||Count of Participants
2579572|NCT02415595|Secondary|Number of Participants With Plasma HIV-1 RNA < 200 c/mL at Week 24 Using FDA Snapshot Algorithm|Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV-1 RNA <200 c/mL at Week 24 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response.|Week 24|mITT Population|||Participants|||Count of Participants
2579573|NCT02415595|Secondary|Number of Participants With Plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 Using FDA Snapshot Algorithm|Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV 1 RNA <40 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. The analysis was performed using mITT Population (observed), which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). The data was not collected for Week 96 analysis; as the study was terminated early. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).|Weeks 48 and 96|mITT Population (observed)|||Participants|||Count of Participants
2579574|NCT02415595|Primary|Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24 Using Food and Drug Administration (FDA) Snapshot Algorithm|Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV 1 RNA <40 c/mL at Week 24 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window (18 to 30 weeks) to determine response. Analysis was performed on mITT Population, which comprised of randomized participants who received at least 1 dose of BMS-955176/GSK3532795 or EFV.|Week 24|mITT Population|||Participants|||Count of Participants
2579575|NCT02415439|Primary|Peak Plasma Concentration (Cmax) of VBP15 After 14 Daily Doses of VBP15||Participants will be followed for the duration of hospital stay of 15 days||||(ng/mL)||Standard Deviation|Mean
2579576|NCT02415439|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) After 14 Daily Doses of VBP15 (0 Through 72 Hours Post Dose)||Participants will be followed for the duration of hospital stay of 15 days||||(hr*ng/mL)||Standard Deviation|Mean
2579577|NCT02415439|Primary|Number of Subjects With Adverse Effects After 14 Daily Doses of VBP15||Participants will be followed for the duration of hospital stay of 15 days||||participants|||Number
2579578|NCT02415439|Primary|Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15||Participants will be followed for the duration of hospital stay of 4 days||||(ng/mL)||Standard Deviation|Mean
2579579|NCT02415439|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose)||Participants will be followed for the duration of hospital stay of 4 days||||(hr*ng/mL)||Standard Deviation|Mean
2579580|NCT02415439|Primary|Number of Subjects With Adverse Effects After a Single Dose of VBP15||Participants will be followed for the duration of hospital stay of 4 days||||participants|||Number
2579621|NCT02414854|Secondary|Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52|Analysis was performed ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.|||liter||Standard Deviation|Mean
2580255|NCT02408263|Primary|Numeric Pain Rating Scale|Numeric Pain Rating Scale, 0 (no pain) to 10 (worst pain)|Baseline, Postoperative day 1, Postoperative Day 2||||units on a scale||Standard Deviation|Mean
2579581|NCT02415400|Secondary|The Composite Endpoints of Death and Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Aspirin Versus no Aspirin|"Time to first death or ischenic event during the 6-month treatment period with aspirin or placebo.~N is the number of participants treated with aspirin or placebo.~n is the number of participants treated with aspirin or placebo with death or ischemic events in each treatment group during the 6-month treatment period.~Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year."|Approximately 6 months|"Participants randomized to aspirin or placebo.~Assessment is only for the Acetylsalicylic acid film coated tablet or Placebo matching Acetylsalicylic acid film coated tablet interventions."|||Percentage per year|||Number
2579582|NCT02415400|Secondary|The Rate of the Composite Endpoint of Death or Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Apixaban Versus VKA|"Time to first occurrence during the 6-month treatment period with Apixaban or VKA.~N is the number of participants treated with Apixaban or VKA.~n is the number of participants treated with Apixaban or VKA with death or ischemic events in each treatment group during the during the 6-month period of treatment.~Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year."|Approximately 6 months|"Participants randomized to Apixaban or VKA.~Assessment is only for the Apixaban or VKA interventions."|||Percentage per year|||Number
2579583|NCT02415400|Secondary|The Rate of All-cause Death or All-cause Rehospitalization With Aspirn Versus no Aspirin|"Time to first all-cause death or all-cause hospitalization during the 6-month period of treatment with aspirin or placebo.~N is the number of participants treated with aspirin or placebo.~n is the number of participants treated with aspirin or placebo with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment.~Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year."|Approximately 6 months|"Participants randomized to aspirin or placebo.~Assessment is only for the Acetylsalicylic acid film coated tablet or Placebo matching Acetylsalicylic acid film coated tablet interventions."|||Percentage per year|||Number
2579584|NCT02415400|Secondary|The Rate of All-cause Death or All-cause Rehospitalization With Apixaban Versus VKA|"Time to first all-cause death or all-cause hospitalization during the during the 6-month treatment period with Apixaban or VKA.~N is the number of participants treated with Apixaban or VKA.~n is the number of participants treated with Apixaban or VKA with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment.~Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year."|Approximately 6 months|"Participants randomized to Apixaban or VKA.~Assessment is only for the Apixaban or VKA interventions."|||Percentage per year|||Number
2579585|NCT02415400|Secondary|Superiority on ISTH Major or CRNM Bleeding for Apixaban Versus VKA|"Time to first occurrence during the time the participants were treated with Apixaban or VKA.~N is the number of participants treated with Apixaban or VKA.~n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment.~Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year."|Approximately 6 months|"Participants treated with Apixaban or VKA.~Assessment is only for the Apixaban or VKA interventions."|||Percentage per year|||Number
2579586|NCT02415400|Primary|The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period|"Time to first ISTH major or CRNM bleeding during the treatment period of 6 months with aspirin or placebo.~N is the number of participants with aspirin or placebo.~n is the number of participants treated with aspirin or placebo with major or CRNM bleeding in each treatment group during the 6-month period of treatment.~Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year."|Approximately 6 months|"Participants treated with aspirin or placebo.~Assessment is only for the Acetylsalicylic acid film coated tablet or Placebo matching Acetylsalicylic acid film coated tablet interventions."|||Percentage per year|||Number
2579587|NCT02415400|Primary|The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period|"Time to first ISTH major or CRNM bleeding during the 6-month period of treatment with Apixaban or VKA.~N is the number of participants treated with Apixaban or VKA.~n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment.~Event rates are calculated based on the number of participants with major or CRNM bleeding divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year."|Approximately 6 months|"Participants treated with Apixaban or VKA.~Assessment is only for the Apixaban and VKA interventions."|||Percentage per year|||Number
2579588|NCT02415244|Primary|Number of Thoracic Spinal Segments Successfully Visualized With TEE|Count the number of short axis views of thoracic spinal cord segment and surrounding structure visualized with TEE in pediatric and adults patients.|within 30 minutes||||Thoracic segments||Inter-Quartile Range|Median
2579589|NCT02415166|Other Pre-specified|DIAGNOSTIC GROUP DIFFERENCES IN THE BOLD RESPONSE (Using fMRI) TO MONETARY REWARDS IN THE VENTRAL STRIATUM||2 DAYS|||||||
2579590|NCT02415166|Other Pre-specified|DIFFERENCES IN RESTING STATE CEREBRAL BLOOD FLOW BETWEEN MDD AND HC GROUPS||2 DAYS|||||||
2579591|NCT02415166|Other Pre-specified|IL-6 AND TNF PRODUCTION BY STIMULATED AND UNSTIMULATED MONOCYTE CELLS||2 DAYS|Data not analyzed||||||
2579592|NCT02415166|Secondary|THE INFLUENZA VIRUS-INDUCED PROLIFERATION OF CD4+ MEMORY T-CELLS|Data not collected.|ONE MONTH|Unmedicated participants with major depressive disorder. Data were not collected.||||||
2581818|NCT02388568|Secondary|Body Weight|This is the change in weight from baseline (screening visit) to the final week 52 medical assessment visit.|-14 week (start of LCD program) to week 52||||kg||Standard Error|Mean
2579595|NCT02415127|Secondary|Number of FARS-mNeuro Responders and Non-Responders at Week 26|A participant was considered a responder if they had an improvement (decrease) of at least 3 points from Baseline at Week 26 for the FARS-mNeuro score. The FARS assessment includes neurological signs that specifically reflect neural substrates affected in FA. Based on a neurological examination, bulbar, upper limb, lower limb, peripheral nerve, and upright stability/gait functions were assessed. The FARS-mNeuro score excludes the peripheral nervous system subscale score and the facial and tongue atrophy and fasciculations from the bulbar subscale score. Scores range from 0 (normal) to 93 (most impairment).|Week 26|ITT Population: All randomized participants with a valid baseline (including Screening) and at least 1 valid post baseline measurement in the primary efficacy outcome (FARS-mNeuro) and data at Week 26. A valid FARS-mNeuro score was defined as no missing values in the questionnaire.|||Participants|||Count of Participants
2579596|NCT02415127|Secondary|Change From Baseline at Week 26 in Timed 25-Foot Walk (T25FW)|The T25FW is a quantitative measure of lower extremity function. Participants are directed to 1 end of a clearly marked 25-foot course and instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the participant walk back the same distance, and the score for the test is the average of the 2 walks (after reciprocal transformation). Participants may use assistive devices when performing this task, with the same assistive device used at each assessment. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population: All randomized participants with a valid baseline (including Screening) and at least 1 valid post baseline measurement in the primary efficacy outcome (FARS-mNeuro), and T25FW data at Baseline and Week 26. A valid FARS-mNeuro score was defined as no missing values in the questionnaire.|||1/seconds||Standard Deviation|Mean
2579597|NCT02415127|Secondary|Change From Baseline to Week 26 in Activities of Daily Living (ADL) Score|Participants and/or their caregivers rated 9 areas of daily living skills (speech, swallowing, cutting food and handling utensils, dressing, personal hygiene, falling, walking, quality of sitting position, and bladder function) on a 5-point scale (0=normal, 4=greatest loss of function) with allowable increments of 0.5 if the participant or caregiver strongly felt that a task falls between 2 scores. ADL scores can range from 0 (normal) to 36 (greatest loss of function). A negative change from baseline indicates improvement.|Baseline, Week 26|ITT Population: All randomized participants with a valid baseline (including Screening) and at least 1 valid post baseline measurement in the primary efficacy outcome (FARS-mNeuro) and ADL data at Baseline and Week 26. A valid FARS-mNeuro score was defined as no missing values in the questionnaire.|||units on a scale||Standard Deviation|Mean
2579598|NCT02415127|Primary|Change From Baseline to Week 26 in the Friedreich's Ataxia Rating Scale (FARS)-mNeuro Score|The FARS assessment includes neurological signs that specifically reflect neural substrates affected in FA. Based on a neurological examination, bulbar, upper limb, lower limb, peripheral nerve, and upright stability/gait functions were assessed. The FARS-mNeuro score excludes the peripheral nervous system subscale score and the facial and tongue atrophy and fasciculations from the bulbar subscale score. Scores range from 0 (normal) to 93 (most impairment). A negative change from baseline is an improvement.|Baseline, Week 26|Intent-to-Treat (ITT) Population: All randomized participants with a valid baseline (including Screening) and at least 1 valid post baseline measurement in the primary efficacy outcome (FARS-mNeuro) and at Week 26. A valid FARS-mNeuro score was defined as no missing values in the questionnaire.|||units on a scale||Standard Deviation|Mean
2579599|NCT02414958|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 26|Change from baseline in SBP and DBP is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline.|Baseline to week 26|FAS observed cases excluding data after change in use of anti-hypertensives (OC-H)|||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2579600|NCT02414958|Secondary|Change From Baseline in Total Daily Insulin Dose (TDID) at Week 26|Change from baseline in TDID is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline.|Baseline to week 26|FAS (OC)|||Unit/kilogram (U/kg)||Standard Error|Least Squares Mean
2579601|NCT02414958|Secondary|Change From Baseline in Interstitial Glucose Variability Based on the Interquartile Range (IQR) as Determined by CGM in Weeks 23 to 26|Change from baseline in interstitial glucose variability based on the IQR as determined by CGM is presented for week 23 to 26. Least squares mean is actually an adjusted event rate.|Week 23 to 26|FAS observed cases excluding data after use of paracetamol (OC-P)|||milligrams (mg)/ deciliter (dL)||Standard Error|Least Squares Mean
2579602|NCT02414958|Secondary|Change From Baseline in Percentage of Time Spent in Target Glucose Range From Weeks 23 to 26|Change from baseline in the percentage of time spent in target glucose range of >70 to ≤180 mg/dL (>3.9 to ≤10.0 mmol/L) as determined by continuous glucose monitoring (CGM) is presented in week 23 to 26. Least squares mean is actually an adjusted event rate.|Week 23 to 26|FAS observed cases excluding data after use of paracetamol (OC-P)|||Percentage of time||Standard Error|Least Squares Mean
2579603|NCT02414958|Secondary|Change From Baseline in Body Weight at Week 26|Change from baseline in body weight is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline.|Baseline to week 26|FAS (OC)|||Kilogram (kg)||Standard Error|Least Squares Mean
2579604|NCT02414958|Secondary|Rate Per Patient-year of Investigator-reported Symptomatic Hypoglycaemia Adverse Events (AEs) With Confirmed Plasma Glucose (PG)|This is a key secondary endpoint. Rate per patient-year of investigator-reported symptomatic hypoglycaemia adverse events (AEs) with confirmed plasma glucose (PG) <54 milligram per deciliter (mg/dL) (<3.0 millimoles per litre (mmol/L)) and/or severe hypoglycaemia AEs (i.e. all investigator-reported AEs that had confirmed PG <54 mg/dL [<3.0 mmol/L] with symptoms reported and all severe hypoglycaemia events that were confirmed by adjudication) is presented for (i) From week 5 to 26 and (ii) From week 1 to 26. Least squares mean is actually an adjusted event rate.|Week 5 to Week 26, Week 1 to Week 26|FAS (OC)|||Event per patient year||95% Confidence Interval|Least Squares Mean
2580434|NCT02406495|Primary|Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D|Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.|Baseline and 1 Week||||percentage of eyes|||Number
2579605|NCT02414958|Primary|Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26 for Modified Intention-to-treat Population Set (mITT) (Observed Case (OC) - All Data (AD) (OC-AD) )|Change from baseline in glycated haemoglobin (HbA1c) for modified intention-to-treat population set (mITT) (observed case - all data [OC-AD]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects.|Baseline to week 26|Modified intention-to-treat set (mITT) (observed case – all data [OC-AD]): Patients in the TS who had a baseline and at least 1 post-baseline HbA1c measurement.|||Percentage (%)||Standard Error|Least Squares Mean
2579606|NCT02414958|Primary|Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 26|Change from baseline in glycated haemoglobin (HbA1c) for full analysis set (FAS) (observed cases [OC]) is presented. With regards to efficacy and safety endpoints, the term 'baseline' referred to the last observed measurement prior to administration of any randomised trial medication. Least squares mean is adjusted mean change from baseline. Restricted maximum likelihood estimation based on mixed-effect model for repeated measures (MMRM) analysis was used to obtain adjusted means for the treatment effects.|Baseline to week 26|Full analysis set (FAS) (observed cases [OC]): Patients in the Treated Set (TS) who had a baseline and at least 1 on-treatment HbA1c measurement; the FAS was the basis for the primary efficacy analysis|||Percentage (%)||Standard Error|Least Squares Mean
2579607|NCT02414854|Secondary|Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis|RQLQ(S)+12 is a self-administered questionnaire with standardized activities developed to measure health-related quality of life signs and symptoms that are most problematic in those 12 to 75 years of age, as a result of perennial or seasonal allergic rhinitis. There are 28 items on RQLQ(S) in 7 domains: activities (3 items), sleep (3 items), non-nose/eye symptoms (7 items), practical problems (3 items), nasal symptoms (4 items), eye symptoms (4 items) and emotional (4 items). RQLQ(S)+12 responses are based on 7-point likert scale with responses ranging from 0 (not troubled) to 6 (extremely troubled). Individual items within RQLQ(S)+12 are equally weighted. The overall score is calculated as the mean score of all items. Higher scores indicated more health-related quality of life impairment (lower scores better).|Baseline, Weeks 12, 24, 36, and 52|Analysis was performed on ITT population with comorbid allergic rhinitis. Here 'Number analyzed' signifies number of participants with available data for specified category.|||scores on a scale||Standard Deviation|Mean
2579608|NCT02414854|Secondary|Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis|The SNOT-22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life.|Baseline, Weeks 12, 24, 36, and 52|Analysis was performed on ITT population with bilateral nasal polyposis/chronic rhinosinusitis. Here 'Number analyzed' signifies number of participants with available data for specified category.|||scores on a scale||Standard Deviation|Mean
2579609|NCT02414854|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population|The HADS is a general scale to detect states of anxiety and depression already used and validated in asthma, which includes HADS-A and HADS-D subscales. The instrument is comprised of 14 items: 7 related to anxiety (HADS-A) and 7 to depression (HADS-D). Each item on the questionnaire is scored from 0-3. The anxiety/depression score is the sum of the scores of the 7 related items; one can score between 0 and 21 for either anxiety or depression. And the total score is the sum of the scores of the 14 items ranging from 0 (no symptoms) to 42 (severe symptoms), with higher scores indicating higher anxiety/depression complains.|Baseline, Weeks 12, 24, 36, and 52|Analysis was performed on ITT population; 29 participants in Japan who received an incorrectly translated HADS questionnaire were excluded. Here 'Number analyzed' signifies number of participants with available data for specified category.|||scores on a scale||Standard Deviation|Mean
2579610|NCT02414854|Secondary|Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population|EQ-5D-5L is a standardized health-related quality of life questionnaire developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable).|Baseline, Weeks 12, 24, 36, and 52|Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.|||scores on a scale||Standard Deviation|Mean
2579611|NCT02414854|Secondary|Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population|The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.|Baseline, Weeks 12, 36, and 52|Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.|||scores on a scale||Standard Deviation|Mean
2579626|NCT02414854|Secondary|Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Weeks 2, 4, 8, 24, 36, and 52|Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.|||percent change||Standard Deviation|Mean
2579612|NCT02414854|Secondary|Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population|Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study. The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded daily by the participants in an electronic diary/peak expiratory flow (PEF) meter. In the case that Nebulizer solutions were used as an alternative delivery method, the nebulizer dose was converted to number of puffs as per following conversion factor: salbutamol/albuterol nebulizer solution (2.5 mg) corresponds to 4 puffs.|Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52|Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.|||Number of puffs of reliever medication||Standard Deviation|Mean
2579613|NCT02414854|Secondary|Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population|Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night.|Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52|Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.|||number of nocturnal awakenings/night||Standard Deviation|Mean
2579614|NCT02414854|Secondary|Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population|Evening asthma symptom score was determined using PM (post meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.|Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52|Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.|||scores on a scale||Standard Deviation|Mean
2579615|NCT02414854|Secondary|Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population|Morning asthma symptom score was determined using AM (ante meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night. It ranged from 0 to 4 as: 0= No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.|Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52|Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.|||scores on a scale||Standard Deviation|Mean
2579616|NCT02414854|Secondary|Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population|The ACQ-7 has 7 questions, the first 5 questions assess the most common asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze plus short-acting bronchodilator use, and FEV1 (pre-bronchodilator % predicted). Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). Clinic staff scored the FEV1% predicted on a 7-point scale. The questions were equally weighted and the ACQ-7 total score was mean of the scores of all 7 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.|Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52|Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.|||scores on a scale||Standard Deviation|Mean
2579617|NCT02414854|Secondary|Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population|The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.|Baseline, Weeks 2, 4, 8, 12, 36, and 52|Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.|||scores on a scale||Standard Deviation|Mean
2579618|NCT02414854|Secondary|Time to First LOAC Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population|The time to first LOAC event was defined as follows: date of the first event - first dose date +1. For participants who had no event on or before last dose date + 14 days or last contact date, the time was censored at the last dose date + 14 days or the last contact date, whichever was earlier.|Baseline up to Week 52|Analysis was performed on ITT population.|||days||95% Confidence Interval|Median
2579619|NCT02414854|Secondary|Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population|The time to first severe exacerbation was defined as follows: date of the first event - randomization date +1. For participants who had no event on or before Visit 18 (Week 52) or last contact date, the time was censored at the date of Visit 18 or the last contact date, whichever was earlier. The median time to first severe exacerbation was not estimated; therefore, the probability of severe exacerbation at Weeks 12, 24, 36, and 52, are presented as the descriptive statistics.|Baseline up to Week 52|Analysis was performed on ITT population.|||probability of severe exacerbation||95% Confidence Interval|Number
2579620|NCT02414854|Secondary|Annualized Rate of Loss of Asthma Control (LOAC) Event During The 52-Week Treatment Period: ITT Population|LOAC was defined as any of the following: >=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS >=4 times the dose at randomization; use of systemic corticosteroids for >=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 52|Analysis was performed on ITT population.|||LOAC per participant-year||95% Confidence Interval|Number
2579630|NCT02414854|Secondary|Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|Analysis was performed on ITT population with baseline eosinophil >=0.3 Giga/L. 'Overall number of participants analyzed'=participants evaluable for this outcome measure at specified timepoint.|||percent change||Standard Deviation|Mean
2579631|NCT02414854|Secondary|Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil <0.3 Giga/L|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|Analysis was performed ITT population with baseline eosinophil <0.3 Giga/L. 'Overall number of participants analysed'=participants evaluable for this outcome measure at specified timepoint.|||liter||Standard Deviation|Mean
2579632|NCT02414854|Secondary|Annualized Rate of Severe Exacerbation Events Resulting in Hospitalization or Emergency Room Visit During The 52-Week Treatment Period: ITT Population|A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations (resulted hospitalization or emergency room visit) that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 52|Analysis was performed on ITT population.|||Exacerbation per participant-year||95% Confidence Interval|Number
2579633|NCT02414854|Secondary|Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population|The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.|Baseline, Week 24|Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.|||scores on a scale||Standard Deviation|Mean
2579634|NCT02414854|Secondary|Change From Baseline in AQLQ (S) Self- Administered Global Score at Week 24: ITT Population With Baseline Eosinophil >=0.3 Giga/L|The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.|Baseline, Week 24|Analysis was performed on ITT population with baseline eosinophil >=0.3 Giga/L. Here 'Number analyzed' signifies number of participants with available data for specified category.|||scores on a scale||Standard Deviation|Mean
2579635|NCT02414854|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population|The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.|Baseline, Week 24|Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.|||scores on a scale||Standard Deviation|Mean
2579636|NCT02414854|Secondary|Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|Analysis was performed on ITT population with high dose ICS at baseline. 'Overall number of participants analysed'=participants evaluable for this outcome measure at specified timepoint.|||liter||Standard Deviation|Mean
2579637|NCT02414854|Secondary|Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With High Dose ICS at Baseline|A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 52|Analysis was performed on ITT population with high dose ICS at baseline.|||Exacerbation per participant-year||95% Confidence Interval|Number
2579638|NCT02414854|Secondary|Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil <0.3 Giga/L|A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 52|Analysis was performed on ITT population with baseline eosinophil <0.3 Giga/L.|||Exacerbation per participant-year||95% Confidence Interval|Number
2579639|NCT02414854|Secondary|Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|Analysis was performed ITT population with baseline eosinophil >=0.3 Giga/L. Here 'Number analyzed' signifies number of participants with available data for specified category.|||liter||Standard Deviation|Mean
2579727|NCT02413398|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24.|"To compare the mean change from baseline in FPG between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The number analyzed represents the number with change from baseline available at Week 24."|Baseline, Week 24||||mg/dL||Standard Error|Mean
2579640|NCT02414854|Secondary|Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.3 Giga/L|A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 52|Analysis was performed on ITT population with baseline eosinophil >=0.3 Giga/L.|||Exacerbation per participant-year||95% Confidence Interval|Number
2579641|NCT02414854|Secondary|Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|Analysis was performed ITT population with baseline eosinophil >=0.15 Giga/L. Here 'Number analyzed' signifies number of participants with available data for specified category.|||liter||Standard Deviation|Mean
2579642|NCT02414854|Secondary|Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.15 Giga/L|A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 52|Analysis was performed ITT population with baseline eosinophil >=0.15 Giga/L.|||Exacerbation per participant-year||95% Confidence Interval|Number
2579643|NCT02414854|Secondary|Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|Analysis was performed on ITT population. 'Overall number of participants analyzed'=participants evaluable for this outcome measure.|||percent change||Standard Deviation|Mean
2579644|NCT02414854|Primary|Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|Analysis was performed on ITT population. Here 'Number analyzed' signifies number of participants with available data for specified category.|||liter||Standard Deviation|Mean
2579645|NCT02414854|Primary|Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population|A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 52|Analysis was performed on ITT population that included all randomized population analyzed according to the treatment group allocated by randomization.|||Exacerbation per participant-year||95% Confidence Interval|Number
2579646|NCT02414841|Primary|Number of Participants With AVF Use for Hemodialysis|AVF use for hemodialysis is defined as the ability of the study AVF to be successfully cannulated and used for hemodialysis for a minimum of 90 days or at least 30 days prior to a patient's last visit, if hemodialysis has not been initiated at least 90 days prior to the patient's last visit. If AVF use is not defined as above, non-use of the AVF for hemodialysis is defined as an abandoned fistula prior to use; or if hemodialysis is recorded on 2 consecutive visits and there is no cannulation date or duration of use is less than 90 days. The patients who are not categorized as having use or non-use of the AVF have insufficient data to determine AVF use for hemodialysis and will be categorized as having indeterminate use.|Assessed at up to 12 Months|Patients having use or non-use of their AVF. Patients with indeterminate use of their AVF were excluded.|||Participants|||Count of Participants
2579647|NCT02414841|Primary|Kaplan-Meier Estimate of Secondary AVF Patency|Kaplan-Meier estimate of median time from AVF creation until AVF abandonment (secondary patency)|Median time from AVF creation to AVF abandonment (secondary patency), assessed up to 1 year.|Full analysis set includes all 613 patients who were randomized|||Days||95% Confidence Interval|Median
2579648|NCT02414828|Secondary|"Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the Post TB Treatment Stratum"|Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.|42 days post dose||||percentage of T Cell response||95% Confidence Interval|Median
2579649|NCT02414828|Secondary|"Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the Post TB Treatment Stratum"|Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.|42 days post dose||||percentage of T Cell response||95% Confidence Interval|Median
2579650|NCT02414828|Secondary|"Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the on TB Treatment Stratum"|Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.|42 days post dose||||percentage of T Cell response||95% Confidence Interval|Median
2579651|NCT02414828|Primary|Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)|Maximum number of subjects with deterioration >15% from baseline, at any time point, in diffusing capacity of the lung for carbon monoxide (DLCO)|182 Days|Subjects who were evaluated.|||participants|||Number
2579652|NCT02414828|Primary|Forced Vital Capacity (FVC)|Maximum number of subjects with deterioration >10% from baseline, at any time point, in forced vital capacity (FVC)|182 days|Subjects who were evaluated.|||participants|||Number
2584382|NCT02357394|Secondary|Neonatal Length of Stay|Total number of days in hospital after birth|participants will be followed for the duration of hospital stay, up to 17 weeks after delivery||||days||Full Range|Mean
2579654|NCT02414828|Secondary|"Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the on TB Treatment Stratum"|Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.|42 days post dose||||percentage of T Cell response||95% Confidence Interval|Median
2579655|NCT02414828|Primary|Number of Participants With Solicited and Unsolicited AEs|All adverse events will be summarized to examine the relationship between dose levels including number (percentage) of solicited and unsolicited adverse events (AEs), and number (percentage) of subjects with newly abnormal post-vaccination laboratory values based on predefined toxicity criteria.|182 days||||participants|||Number
2579656|NCT02414698|Other Pre-specified|Adverse Events|Procedure and device related adverse events|24 months|||||||
2579657|NCT02414698|Other Pre-specified|Independent Physician Assessment (McNab Criteria)||24 months|||||||
2579658|NCT02414698|Other Pre-specified|Global Improvement Impression of Change (PGIC)|Patient self assessment of the Global Improvement Impression of Change (PGIC)|24 months|||||||
2579659|NCT02414698|Secondary|Change From Baseline ED-5Q Questionnaire||24 months|Data were not collected||||||
2579660|NCT02414698|Secondary|Change From Baseline Oswestry Disability Index (ODI)||24 months|Data were not collected||||||
2579661|NCT02414698|Primary|Number of Patients in Each Group That Experience at Least a 50% Reduction in Leg and Back Pain|Pain improvement in all patients in HydroD arm with at least 50% reduction in leg and back pain.|6 months|Data were not collected.||||||
2579662|NCT02414633|Secondary|Number of Participants With Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probable, possible, not related, or impossible to judge. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the physician obtained the patient's authorization or informed consent until the end of the study (week 28 or discontinuation).|From the first dose of study drug until the end of the study (up to 24 weeks)|Safety analysis population: All participants enrolled in the study.|||participants|||Number
2579663|NCT02414633|Secondary|Nail Psoriasis: Change From Baseline to Final Visit|The percentage of participants with nail psoriasis .|Baseline (Week 0) and final visit (up to 24 weeks)|Efficacy analysis population|||percentage of participants|||Number
2579664|NCT02414633|Secondary|Spondylitis: Change From Baseline to Final Visit|The percentage of participants with spondylitis.|Baseline (Week 0) and final visit (up to 24 weeks)|Efficacy analysis population|||percentage of participants|||Number
2579665|NCT02414633|Secondary|Dactylitis: Change From Baseline to Final Visit|The percentage of participants with dactylitis.|Baseline (Week 0) and final visit (up to 24 weeks)|Efficacy analysis population|||percentage of participants|||Number
2579666|NCT02414633|Secondary|Enthesitis: Change From Baseline to Final Visit|The percentage of participants with enthesitis.|Baseline (Week 0) and final visit (up to 24 weeks)|Efficacy analysis population|||percentage of participants|||Number
2579667|NCT02414633|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI): Change From Baseline to Weeks 12 and 24|The HAQ-DI is a patient-reported outcome which is usually self-administered by the patient. The HAQ-DI assesses the categories of dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. The patients report the amount of difficulty they have in performing these activities using a scale ranging from 0 (can be performed without any difficulty) to 3 (cannot be done at all). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.|Baseline (Week 0), Week 12, and Week 24|Efficacy analysis population with evaluable data|||units on a scale||Standard Deviation|Mean
2579668|NCT02414633|Secondary|Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Change From Baseline to Weeks 12 and 24|The BASDAI uses a scale from 1 (no problem) to 10 (worst problem) to answer 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (also called enthesitis, or inflammation of tendons and ligaments), morning stiffness duration, and morning stiffness severity. To give each symptom equal weighting, the mean (average) of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final BASDAI score ranging from 0-10. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.|Baseline (Week 0), Week 12, and Week 24|Efficacy analysis population with evaluable data|||units on a scale||Standard Deviation|Mean
2579669|NCT02414633|Secondary|Swollen Joint Count (SJC66): Change From Baseline to Weeks 4, 12, 16 and 24|"At each study visit, a joint evaluator assessed whether a particular joint was swollen where presence of swelling was scored as 1 and the absence of swelling was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total SJC66, which is based on 66 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 was 0 to 66, with a higher score indicating a greater degree of swelling. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement."|Baseline (Week 0), Week 4, Week 12, Week 16, and 24|Efficacy analysis population with evaluable data|||swollen joints||Standard Deviation|Mean
2579827|NCT02413047|Secondary|Improvement or Normalization of the Simple Endoscopic Score-Crohn's Disease (SES-CD)|SESCD is the simple endoscopic score for crohn's disease patients scored during endoscopy. The scoring is based on appearance of ulcers/sizing, % of ulcerative surface, % of affected surface, and if there were any narrowings or strictures found.|4 months|Not enough subjects for analysis||||||
2579670|NCT02414633|Secondary|Tender Joint Count (TJC68): Change From Baseline to Weeks 4, 12, 16 and 24|"At each study visit, a joint evaluator assessed whether a particular joint was tender or painful where presence of tenderness was scored as 1 and the absence of tenderness was scored as 0, provided the joint was not replaced or could not be assessed due to other reasons. The total TJC68, which is based on 68 joints, was derived as the sum of all 1s thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for TJC68 was 0 to 68, with a higher score indication a greater degree of tenderness. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement."|Baseline (Week 0), Week 4, Week 12, Week 16, and 24|Efficacy analysis population with evaluable data|||tender joints||Standard Deviation|Mean
2579671|NCT02414633|Secondary|Disease Activity Score 28, Erythrocyte Sedimentation Rate (DAS28 [ESR]): Change From Baseline to Weeks 4, 12, 16 and 24|DAS28 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.|Baseline (Week 0), Week 4, Week 12, Week 16, and 24|Efficacy analysis population with evaluable data|||units on a scale||Standard Deviation|Mean
2579672|NCT02414633|Secondary|Disease Activity Score 28, C-reactive Protein (DAS28 [CRP]): Change From Baseline to Weeks 4, 12, 16 and 24|DAS28 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.|Baseline (Week 0), Week 4, Week 12, Week 16, and 24|Efficacy analysis population with evaluable data|||units on a scale||Standard Deviation|Mean
2579673|NCT02414633|Secondary|Psoriasis Area and Severity Index (PASI) Score: Change From Baseline to Weeks 4, 12, 16 and 24|PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on of the lesions rated on a a scale from 0 (no symptoms) to 4 (very marked), together with the percentage of the area affected, rated on a scale from 0 (0%) to 6 (100%). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.|Baseline (Week 0), Week 4, Week 12, Week 16, and 24|Efficacy analysis population with evaluable data|||units on a scale||Standard Deviation|Mean
2579674|NCT02414633|Secondary|Psoriatic Arthritis Screening and Evaluation Questionnaire (PASE): Change From Baseline to Weeks 4, 12, 16 and 24|The PASE is a patient-administered questionnaire used to screen patients with psoriasis for evidence of psoriatic arthritis. The PASE consists of 15 questions divided into 2 subscales (system sub-scale and function sub-scale); 7 questions assess symptoms and 8 questions assess function. Questions are scored on a numeric scale ranging from 1 (strongly disagree) to 5 (strongly agree), with a total possible PASE score of 15 to 75. Individuals who are more likely to have PsA will score higher than individuals without PsA. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.|Baseline (Week 0), Week 4, Week 12, Week 16, and 24|Efficacy analysis population|||units on a scale||Standard Deviation|Mean
2579675|NCT02414633|Secondary|WPAI:PsA Activity Impairment: Change From Baseline to Weeks 4, 12, 16 and 24|WPAI:PsA is a questionnaire used to evaluate lost productivity due to PsA; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Activity impairment (percentage of activity impairment due to PsA) is calculated as the patient's rating of how much PsA affected their ability to do regular daily activities, other than working at a job (0 = no effect; 10 = completely prevented from working) / 10 * 100. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.|Baseline (Week 0), Week 4, Week 12, Week 16, and 24|Efficacy analysis population with evaluable data|||percentage of impairment||Standard Deviation|Mean
2579676|NCT02414633|Secondary|WPAI:PsA Presenteeism: Change From Baseline to Weeks 4, 12, 16 and 24|WPAI:PsA is a questionnaire used to evaluate lost productivity due to PsA; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Presenteeism (percentage of impairment while working due to PsA) is calculated as the patient's rating of how much PsA affected productivity while working (0 = no effect; 10 = completely prevented from working) / 10 * 100. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.|Baseline (Week 0), Week 4, Week 12, Week 16, and 24|Efficacy analysis population|||percentage of impairment while working||Standard Deviation|Mean
2579677|NCT02414633|Secondary|WPAI:PsA Absenteeism: Change From Baseline to Weeks 4, 12, 16 and 24|WPAI:PsA is a questionnaire used to evaluate lost productivity due to PsA; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Absenteeism (percentage of work time missed due to PsA) is calculated as the number of hours of work missed due to PsA / (number of hours of work missed due to PsA + number of hours worked) * 100. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.|Baseline (Week 0), Week 4, Week 12, Week 16, and 24|Efficacy analysis population|||percentage of work time missed||Standard Deviation|Mean
2579828|NCT02413047|Secondary|Improvement or Normalization of C-reactive Protein, Sedimentation Rate and Fecal Calprotectin|c-reactive protein, sedimentation rate, and fecal calprotectin were collected to monitor the level of inflammation in the subject. Improvement was determined if inflammation level was reduced.|4 months|Not enough subjects for analysis||||||
2579678|NCT02414633|Secondary|WPAI:PsA Percentage of OWI: Change From Baseline to Weeks 4, 12, and 16|WPAI:PsA is a questionnaire used to evaluate lost productivity due to PsA; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Percentage of overall work impairment due to PsA (OWI) is calculated as: Absenteeism + (1 - Absenteeism) * Presenteeism. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.|Baseline (Week 0), Week 4, Week 12, and Week 16|Efficacy analysis population: All enrolled participants with available OWI scores.|||percentage of OWI||Standard Deviation|Mean
2579679|NCT02414633|Primary|Work Productivity and Activity Impairment Psoriatic Arthritis Questionnaire (WPAI:PsA) Percentage of Overall Work Impairment (OWI): Change From Baseline to Week 24|WPAI:PsA is a questionnaire used to evaluate lost productivity due to PsA; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Percentage of overall work impairment due to PsA (OWI) is calculated as: Absenteeism + (1 - Absenteeism) * Presenteeism. Change from baseline was calculated as the value at baseline minus the value at each subsequent time point. A negative change represents improvement.|Baseline (Week 0), Week 24|Efficacy analysis population: All enrolled participants with available OWI scores.|||percentage of OWI||Standard Deviation|Mean
2579680|NCT02414243|Secondary|Cow's Milk Allergy Related Symptoms|"Cow's Milk Allergy related Symptoms recorded at visit 1 and visit 4 using the Vandenplas symptom-based score (SBS).~The scoring ranges from 0 to 33. Each symptom has a maximal score of 6, except respiratory symptoms where the maximal score is 3. If final score ≥ 12, the symptoms are likely cow's milk related. This could potentially be CMPA.~If final score <12, the symptoms are less likely related to cow's milk. Look for other causes."|14 days|41 patients randomized but 30 completed. Results are presented as total score summary . It compares changes between visit 4 and visit 1, and comparison were performed globally. No other result available.|||score on a scale||Standard Deviation|Mean
2579681|NCT02414243|Primary|Hypoallergenicity as Assessed by Reaction to Amino-acid Based Infant Formula|To demonstrate that the test formula does not cause immediate and/or delayed allergic reactions to a double blind placebo control food challenge (DBPCFC) and/or a subsequent open food challenge (OFC). Incidence of immediate and/or delayed allergic reactions to the DBPCFC with the study product and/or active comparator and/or during the subsequent OPEN challenge phase of the study.|14 days|41 subjects were enrolled and randomized to formula sequence. Only 30 subjects completed the Open Challenge with SanorE formula.|||Participants|||Count of Participants
2579682|NCT02414204|Secondary|Number of Participants With a Change in Blood Flow Rate|Blood flow of the fistula at 6 weeks is measured with doppler ultrasound and values of the fistula artery and vein are obtained (ml/min). The difference in blood flow rates of the fistula artery and vein between the sildenafil treated group and placebo group will be assessed.|6 weeks||||Participants|||Count of Participants
2579683|NCT02414204|Primary|Change in Baseline and 2 Week FMD/VP Measurements Between Sildenafil Group and Placebo Group|"For flow mediated dilation studies (FMD), the brachial artery diameter was measured by ultrasound at baseline. An automated floor pressure cuff was inflated on the upper arm to a suprasystolic pressure that was sustained for 5 minutes, and the brachial diameter measurement was repeated 55-65 seconds after releasing the cuff. FMD was calculated as the percentage change in arterial diameter from baseline.~For venous occlusion plethysmography studies (VP), forearm volume was measured using a strain-gauge plethysmography device during application of an upper arm BP cuff at increasing but subsystolic pressures. Venous capacitance slope was estimated from the volume-pressure relationship and expressed as a percentage increase in volume per millimeters of mercury.~The change at baseline and 2 weeks in these measurements between the sildenafil and placebo group will be assessed."|2 weeks||||Change in FMD%||Standard Error|Mean
2579684|NCT02414152|Primary|Response to Anakinra in Corticosteroid Resistant Patients With SSNHL|Patients who had a response to anakinra based on hearing threshold improvement compared to their pre-treatment threshold.|120 days|Zero subjects were analyzed because both enrolled subjects were withdrawn after receiving 56 days of anakinra because no hearing improvement was noted. They did not complete the entire study.||||||
2579685|NCT02413996|Secondary|Drugs Assumption|number of drugs assumpted for each group during rehabilitation recovery|value at day 10|descriptive|||number of drugs assumpted per group|||Number
2579686|NCT02413996|Secondary|Isometric Strength of Quadriceps and Hamstrings|Isometric strength of quadriceps and hamstrings is assessed by dynamometer (newton unit)|baseline and 10 days (value at day 10 minus value at baseline)|Available case analysis|||newton||Standard Deviation|Mean
2579687|NCT02413996|Secondary|Proprioception|assessed by Virtual Reality Rehabilitation System (percentage value of similarity between ideal and patient knee movement trajector)|assessed and reported at 10 day|Available case analysis|||mm||Standard Deviation|Mean
2579688|NCT02413996|Secondary|The Functional Independence Measure (FIM) Scale|The FIM scale assesses physical and cognitive disability focusing on the level of disability indicating the burden of caring for them. The total score is 126 (18=highest disability, 126=no disability).|baseline and 10 days (value at day 10 minus value at baseline)|Available case analysis|||units on a scale||Standard Deviation|Mean
2579689|NCT02413996|Secondary|Global Perceived Effect (GPE)|The GPE scale asks the patient to rate, on a numerical scale, how much their condition has improved or deteriorated since some predefined time point. The GPE was administered at the end of the physiotherapy treatment to measure the effect of the intervention on patients' health status perception. This Likert scale had five response options (5 = Very much improved; 4 = Much improved, 3 = No change, 2 = Much worse, 1 = Very much worse).|assessed and reported at 10 days|Available case analysis|||score on a scale||Standard Deviation|Mean
2579705|NCT02413593|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 12|Full Analysis Set|||percentage of participants|||Number
2579706|NCT02413593|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12||Baseline; Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2579690|NCT02413996|Secondary|Health Related Quality of Life: Euro Quality of Life Five Dimensions Questionnaire (EQ-5D)|The EQ-5D comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.The EQ-5D descriptive system is divided into five levels of perceived problems: LEVEL 1: indicating no problem; LEVEL 2:indicating some problems;LEVEL 3: indicating extreme problems. EQ-5D health states can be summarised using the 5-digit code (e.g., 11111, 12311).The answers given to ED-5D permit to find 243 5-digit codes defining the health states.The 5-digit code are linked to an unique index derived by applying a formula that attaches values (weights) to each of the levels in each dimension.Weights depend on the country (Italian Population-Based Values of EQ-5D HealthStates,Scalone 2013).The index has been calculated by deducting the appropriate weights from 1 which is the best health status as highest score (i.e. the corresponding 5-digit code is 11111) and -0.38 for the worst health status as minimum score (i.e., the corresponding 5-digit code is 33333).|assessed and reported at 10 days|Available case analysis|||units on a scale||Standard Deviation|Mean
2579691|NCT02413996|Secondary|Knee Active Range of Motion|assessed by Virtual Reality Rehabilitation System (degree of movement)|assesed and reported at 10 days|Available case analysis|||degree||Standard Deviation|Mean
2579692|NCT02413996|Secondary|Knee Disability: Western Ontario and McMaster Universities Arthritis Index (WOMAC) Questionnaire|"The WOMAC measures five items for pain (score range 0-500), two for stiffness (score range 0-200), and 17 for functional limitation (score range 0-1700) for a total score of 2400 (0= no disability, 2400= highest disability):~Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing~Stiffness (2 items): after first waking and later in the day~Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties"|baseline and 10 days (value at day 10 minus value at baseline)|Available case analysis|||units on a scale||Standard Deviation|Mean
2579693|NCT02413996|Primary|Pain: Visual Analogue Scale (VAS)|The VAS scale was measured in a range of 0-100 cm (0 no pain and 100 the worst pain)|baseline and 10 days (value at day 10 minus value at baseline)|Available case analysis (drop-out <20%)|||units on a scale||Standard Deviation|Mean
2579694|NCT02413918|Primary|Measure of Response by Change From Baseline to End of Study in BISS Depression and Mania Scale Scores|"The Bipolar Inventory of Symptoms Scale is a reliable and valid measure which assesses Depression and Mania symptoms of bipolar disorder. There are 42 items; each item is rated on a 0-4 scale. The BISS is a clinician-rated instrument. The Scale is rated as follows:~0 Not at all~Slight~Mild~Moderate~Severe Each of the 42 items is rated separately, with a score, based on the most recent 7 day period.~For Depression: Items 1-21 items of the assessment are summed up and multiplied by 4 to give a cumulative score out of 84. The higher the score, the more severe the depression.~For Mania: Items 22-42 are summed up and multiplied by 4 to give a cumulative score out of 84. The higher the score, the more severe the mania. The mean is calculated from the change in score between baseline and week 20."|Baseline and 20 weeks|Subjects who are currently treated with mood stabilizers (Lithium, Divalproex or Lamotrigine), with a diagnosis of Bipolar Disorder I or II.|||percentage change in score on BISS scale|||Number
2579695|NCT02413879|Secondary|Efficacy (Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge)|Comparison of bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge|1 day (end of the procedure and removal of the investigational device)|Two subjects did not have swab results and thus were not included in the intention-to-treat analysis.|||% of participants with contamination|||Number
2579696|NCT02413879|Primary|Safety (Serious Adverse Events Directly Attributable to the Device)|Incidence of Serious Adverse Events directly attributable to the device|30 days|All subjects within the Treatment arm were analyzed (Intention-to-treat).|||Participants|||Count of Participants
2579697|NCT02413879|Primary|Efficacy (Enteric Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge)|Comparison of enteric bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge|1 day (end of the procedure and removal of the investigational device)|Two subjects did not have swab results and thus were not included in the intention-to-treat analysis.|||% of participants with contamination|||Number
2579698|NCT02413684|Secondary|Number of Emergency Department and Hospitalization Visits|Number of emergency department and hospitalization visits will be recorded|13 weeks||||Events||Standard Deviation|Mean
2579699|NCT02413684|Secondary|Number of Emergency Department and Hospitalization Visits|Number of emergency department and hospitalizations visits will be recorded that occurred within the prior year.|Prior Year||||Events||Standard Deviation|Mean
2579700|NCT02413684|Secondary|Change in Pulmonary Function Tests|Measured by spirometry. We measured forced expiratory volume in one second (FEV1) and forced vital capacity both in liters. FEV1 is a measure of airflow obstruction. The change in lung function is the change in these measurements compared to baseline.|baseline, 13 weeks||||liters||Standard Deviation|Mean
2579701|NCT02413684|Secondary|Change in Asthma Symptoms|"Measured by asthma symptom utility index (ASUI). The Asthma Symptom utility Index (ASUI) is a brief, interviewer-administered, patient preference-based scale assessing frequency and severity of asthma-related symptoms and treatment side effects. Number of items 11 items with 2 week recall.~Scores range from 0 (worst possible symptoms) to 1 (no symptoms) Minimal Clinically Important Difference (MCID) > 0.09"|baseline, 13 weeks||||Units on a scale||Standard Deviation|Mean
2579702|NCT02413684|Secondary|Change in Asthma Control|Measured by the Asthma Control Test (ACT), patient self-administered tool for identifying those with poorly controlled asthma. The ACT assesses the frequency of dyspnea and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. 5 items with 4-week recall. The score range is 5-25 with >19 representing good control and <18 representing poor control.|baseline, 13 weeks||||Units on a scale||Standard Deviation|Mean
2579703|NCT02413684|Primary|Rate of Asthma Exacerbations|The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations from baseline to week 13|baseline to week 13||||Events/13 weeks||Standard Deviation|Mean
2579704|NCT02413684|Primary|Rate of Asthma Exacerbations|The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations that occurred 12 weeks before baseline.|12 weeks prior to baseline||||events/12 weeks||Standard Deviation|Mean
2579711|NCT02413580|Secondary|Percentage of Subjects With Clinical Improvement Assessed by the MG Composite|The percentage of subjects with clinical improvement at Day 14 as assessed by the MG Composite scale in the Evaluable population is presented in which clinical improvement is defined as at least 3-point decrease in the MG Composite score. The minimum and maximum scores of the MG Composite scale are 0 and 50, respectively, with a higher score meaning a worse outcome.|Baseline (Day 0) to Day 14|The percentage of subjects with clinical improvement at Day 14 as assessed by the MG Composite scale in the Evaluable population is presented.|||Participants|||Count of Participants
2579712|NCT02413580|Secondary|Percentage of Subjects With Clinical Improvement Assessed by MG-Activities of Daily Living (MG-ADL) Scale|The percentage of subjects with clinical improvement at Day 14 as assessed by the MG-ADL Scale in the Evaluable population is presented, in which clinical improvement is defined as at least 2-point decrease in the MG-ADL score. The minimum and maximum scores of the MG-DAL scale are 0 and 24, respectively, and a higher score means a worse outcome.|Baseline (Day 0) to Day 14|The percentage of subjects with clinical improvement at Day 14 as assessed by the MG-ADL in the Evaluable population is presented.|||Participants|||Count of Participants
2579713|NCT02413580|Secondary|Percentage of Subjects With Clinical Improvement Assessed by QMG|The percentage of subjects with clinical improvement at Day 14 as assessed by the Quantitative Myasthenia Gravis (QMG) scale in the Evaluable population is presented, in which clinical improvement is defined as at least 3-point decrease in QMG score from Baseline (Day 0) to Day 14. The minimum and maximum scores of the QMG scale are 0 and 39, respectively, and a higher score means a worse outcome.|Baseline (Day 0) to Day 14|The percentage of subjects with clinical improvement at Day 14 as assessed by the QMG scale in the Evaluable population is presented.|||Participants|||Count of Participants
2579714|NCT02413580|Primary|Change in Quantitative Myasthenia Gravis (QMG) Scale Score|Mean Change in Quantitative Myasthenia Gravis (QMG) Scale Score from Baseline (Day 0) to Day 14. The minimum and maximum scores of the QMG Scale are 0 and 39, respectively, and a higher score means a worse outcome.|From Baseline (Day 0) to Day 14|The primary efficacy analysis of change in the score of MG symptoms as measured by the change in QMG score from Baseline (Day 0) to Day 14 in the Evaluable population which consisted of all subjects who received the entire dose of Investigational Product (2 g/kg over 2 consecutive days) and had valid baseline and Day 14 QMG Score measurements.|||score on a scale||Standard Deviation|Mean
2579715|NCT02413489|Secondary|Time to Response|Time to response was defined as the duration from the date of the first dose of daratumumab to the earliest date that a response (CR/PR) is first documented.|Approximately 1.9 years|The analysis population was all participants that were treated with daratumumab and who achieved overall response There was insufficient data to perform Kaplan Meier analysis, therefore individual data for each evaluable participant was reported.|||Months|||Number
2579716|NCT02413489|Secondary|Overall Survival (OS)|Overall survival was defined as the duration from the date of the first daratumumab dose to the date of death.|Approximately 1.9 years|The analysis population was all participants that were treated with daratumumab.|||Months||95% Confidence Interval|Median
2579717|NCT02413489|Secondary|Progression Free Survival (PFS)|PFS was defined as the duration from the date of the first daratumumab dose to the date of progression or death, whichever comes first.|Approximately 1.9 years|The analysis population was all participants that were treated with daratumumab.|||Months||95% Confidence Interval|Median
2579718|NCT02413489|Secondary|Duration of Response|Duration of response was the duration from the date of the initial documentation of a response to the date of first documented evidence of progressive disease (PD). PD is defined as any new lesion >1.5 centimeter (cm) in any axis or greater than or equal to (>=) 50% increase in previously involved sites.|Approximately 1.9 years|The analysis population was all participants that were treated with daratumumab and who achieved overall response There was insufficient data to perform Kaplan Meier analysis, therefore individual data for each evaluable participant was reported.|||Months|||Number
2579719|NCT02413489|Primary|Overall Response Rate (ORR)|ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR). As per Revised Response Criteria for Malignant Lymphoma, Lymph node measurements were taken from Computed Tomography (CT), CT portion of the Positron Emission Tomography/Computed Tomography (PET/CT), or Magnetic resonance imaging (MRI) scans where applicable. CR is defined as complete disappearance of all evidence of disease; PR as a greater than (>) 50 percent (%) decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites.|After the first dose until disease progression, withdrawal of consent from study participation, or the end of study (approximately 1.9 years)|The analysis population was all participants that were treated with daratumumab.|||Percentage of participants||95% Confidence Interval|Number
2579720|NCT02413463|Secondary|Number of Patients Who Developed Intraoperative and/or Postoperative Complications|Number of patients who developed intraoperative and postoperative complications as scleral perforation, fat prolapse, slipped and lost muscles|Six months||||Participants|||Count of Participants
2579721|NCT02413463|Secondary|Surgery Time|Time to complete the surgery|Intraoperative time||||Minutes||Standard Deviation|Mean
2579722|NCT02413463|Secondary|Angle Disparity|Difference between largest angle and smallest angle|Six months||||Diopters||Standard Deviation|Mean
2579723|NCT02413463|Secondary|Angle of Deviation Without Spectacles for Both Distance and Near|The angle of deviation after surgery without correction for both distance and near|Six months||||Diopters||Standard Deviation|Mean
2579724|NCT02413463|Secondary|Angle of Deviation With Spectacles for Both Distance and Near|The angle of deviation after surgery with full hypermetropic correction|Six months||||Diopters||Standard Deviation|Mean
2579725|NCT02413463|Primary|Success Rate|Success rate defined as orthotropia or esotropia ≤ 8 prism diopters with the full hypermetropic correction for near and far without changing the preoperative correction.|six months||||Participants|||Count of Participants
2579726|NCT02413398|Secondary|Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure (SBP) at Week 24.|"To compare the mean change from baseline in seated systolic blood pressure (SBP) between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The number analyzed represents the number with change from baseline available at Week 24."|Baseline, Week 24||||mmHg||Standard Error|Mean
2579728|NCT02413398|Secondary|Adjusted Mean Percent Change From Baseline in Total Body Weight at Week 24.|"To compare the mean percent change from baseline in total body weight between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The number analyzed represents the number with change from baseline available at Week 24."|Baseline, Week 24||||percent change||Standard Error|Mean
2579729|NCT02413398|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24|"To compare the mean change from baseline in HbA1c between dapagliflozin 10 mg and placebo, after 24 weeks of oral administration of double-blind treatment in patients with type 2 diabetes, CKD stage 3A, and moderate renal impairment (CKD 3A; eGFR 45-59 mL/min/1.73m^2). The number analyzed (142 dapaglifozin, 134 placebo) represents the number with change from baseline available at Week 24."|Baseline, Week 24|For glycaemic measurements (HbA1c and FPG), all measurements after the first dose of rescue medication were excluded. For other non-glycaemic measurements (body weight and SBP), all measurements after the first dose of rescue medication were included.|||percent||Standard Error|Mean
2579730|NCT02413372|Secondary|Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142|Participants were monitored for antibodies to FGF21 using a validated homogenous bridge assay with Met-FGF21 (recombinant produced) and electrochemical luminescence detection. The number of treated participants with positive Anti-FGF21 antibody titers up to Day 142 with regards to baseline was reported for each arm.|From Day 1 to Day 142|All treated participants|||Participants|||Number
2579731|NCT02413372|Secondary|Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142|Participants were monitored for antibodies to study medication using a validated ADA homogenous bridge assay with BMS-986036 and electrochemical luminescence detection. The number of treated participants with positive Anti-BMS-986036 antibody titers up to Day 142 with regards to baseline was reported for each arm.|From Day 1 to Day 142|All treated participants|||Participants|||Number
2579732|NCT02413372|Secondary|Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112|The observed serum concentration of BMS-986036 before the next dose is administered (pre-dose concentration) was assessed for both C-terminal intact and total molecule. Geometric means are presented for each arm.|From Day 1 to Day 112|All treated participants|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2579733|NCT02413372|Primary|Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA)|The mean percent change in bone mineral density from baseline to day 112 reported for each arm.|From Day 1 to Day 112|All treated participants with DXA data at baseline and 6 months|||Percentage||Standard Deviation|Mean
2579734|NCT02413372|Primary|Number of Participants With Physical Examination Abnormalities|The number of participants with abnormalities observed during interim or final physical examination assessments is reported for each arm.|From first dose to date of last dose plus 30 days|All treated participants|||Participants|||Number
2579735|NCT02413372|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|The number of participants with out-of-range ECG intervals observed during interim or final electrocardiogram assessments was reported for each arm.|From first dose to date of last dose plus 30 days|All treated participants|||Participants|||Number
2579736|NCT02413372|Primary|Number of Participants With Vital Sign Abnormalities|The number of participants with out-of-range vital signs noted during interim or final vital sign assessments was reported for each arm.|From first dose to date of last dose plus 30 days|All treated participants|||Participants|||Number
2579737|NCT02413372|Primary|Number of Participants With Marked Laboratory Abnormalities|The number of participants whose worst toxicity grade increased from baseline to grade 3 or 4 (Toxicity Scale: DAIDS Version 1.0) is reported for each arm.|From first dose to date of last dose plus 30 days|All treated participants|||Participants|||Number
2579738|NCT02413372|Primary|Number of Deaths|The number of deaths was reported for each arm.|From first dose to date of last dose plus 30 days|All treated participants|||Participants|||Number
2579739|NCT02413372|Primary|Number of Participants With Adverse Events Leading to Discontinuation|The number of participants with on-study AEs leading to discontinuation was reported for each arm.|From first dose to date of last dose plus 30 days|All treated participants|||Participants|||Number
2579740|NCT02413372|Primary|Number of Participants With Injection Site Reactions|The number of participants with on-study injection site reactions was reported for each arm.|From first dose to date of last dose plus 30 days|All treated participants|||Participants|||Number
2579741|NCT02413372|Primary|Number of Participants With Serious Adverse Events (SAEs)|The number of participants with on-study SAEs was reported for each arm.|From first dose to date of last dose plus 30 days|All treated participants|||Participants|||Number
2579742|NCT02413372|Primary|Number of Participants With Adverse Events (AEs)|The number of participants with on-study AEs was reported for each arm.|From first dose to date of last dose plus 30 days|All treated participants|||Participants|||Number
2579743|NCT02413372|Primary|Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16|The mean change in percent hepatic fat fraction (%) by MRI from baseline to Week 16 was assessed for each arm. A longitudinal repeated measures analysis was used to analyze the change in hepatic fat fraction (%) at Week 16 from baseline in the treated population who have both a baseline and at least one post-baseline measurement.|From Day 1 to Day 112|All treated participants|||percentage||90% Confidence Interval|Mean
2579744|NCT02413346|Primary|Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE)|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. A TEAE is an AE that occurs after the first dose of study drug.|Up to 40 Weeks|Safety Population included all participants among the screened population who were exposed to study treatment (sarecycline) in either the double-blind lead-in study or this open-label extension study.|||participants|||Number
2579745|NCT02413333|Secondary|Mean Osmolality in Lens Cases at Day 30|The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Osmolality was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).|Day 30, each product|Intention to treat participants with non-missing observations|||milliosmoles/kg (mOsm/kg)|Participants|Standard Deviation|Mean
2579746|NCT02413333|Primary|Mean Residual Peroxide at Day 30|The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).|Day 30, each product|Intention to treat participants with non-missing observations|||parts per million (ppm)|Participants|Standard Deviation|Mean
2579747|NCT02413294|Secondary|Self-Reported Sleep Diary: Sleep Duration|nightly mean of length of sleep measured in minutes|daily for 4 weeks- baseline and intervention period to be compared||||Minutes asleep||Standard Deviation|Mean
2579748|NCT02413294|Secondary|Self-Reported Sleep Diary: Night Awakenings|mean number of night awakenings per person per night as reported in sleep diaries|daily for 4 weeks- baseline and intervention period to be compared||||Number of night awakenings||Standard Deviation|Mean
2579749|NCT02413294|Secondary|Self-Reported Sleep Diary: Sleep Quality|sleep quality is a participants' mean self-report for each of the two week periods: baseline and intervention. Sleep quality is reported for each night on a scale of 0 (very poor) to 4 (very good).|daily for 4 weeks- baseline and intervention period to be compared||||units on a scale||Standard Deviation|Mean
2579750|NCT02413294|Secondary|Self-Reported Sleep Diary: Time at Which Participants Wake up|Wake time represents the moment in time at which participants awaken. Time between actual hours is calculated on a decimal basis so an additional 6 minutes = .1. so that 7.5 represents 7:30 a.m. and 7.8 represents 7:48 a.m.|daily for 4 weeks- baseline and intervention period to be compared||||hour (military time)||Standard Deviation|Mean
2579751|NCT02413294|Secondary|Self-Reported Sleep Diary: Time at Which Participants go to Bed|Bed time represents the moment in time at which participants went to bed, measured on a revised clock where 6pm = 18, Midnight = 24 and 6am =30. Time between actual hours is calculated on a decimal basis, so an additional 6 minutes = .1. This revised clock is necessary in order to make means work properly in the nighttime hours. Otherwise, averaging between a 10pm bedtime and a 2am bedtime would give the impossible, inaccurate mean of being in the daytime between those two numbers.|daily for 4 weeks- baseline and intervention period to be compared||||hour (military time)||Standard Deviation|Mean
2579752|NCT02413294|Secondary|Fitbit Sleep Data: Sleep Efficiency|Sleep efficiency is calculated as a percentage reflecting the amount of time in bed spent asleep (time asleep/time in bed x 100).|daily for 4 weeks- baseline and intervention period||||percentage of time in bed spent asleep||Standard Deviation|Mean
2579753|NCT02413294|Secondary|Fitbit Sleep Data: Night Awakenings|mean nightly awakenings for each of the two week periods: baseline and intervention. Similar to the actigraph the Fitbit counts awakenings through an accelerometer which measures motion.|daily for 4 weeks- baseline and intervention period||||count of night awakenings||Standard Deviation|Mean
2579754|NCT02413294|Secondary|Fitbit Sleep Data: Sleep Duration|mean nightly sleep duration in minutes for each of the two-week periods: baseline and intervention|daily for 4 weeks- baseline and intervention period||||Minutes asleep||Standard Deviation|Mean
2579755|NCT02413294|Secondary|Actigraph: Efficiency|Sleep efficiency is calculated as a percentage reflecting the amount of time in bed spent asleep (time asleep/time in bed x 100). The mean for each of the two-week periods: baseline and intervention, is calculated.|daily for 4 weeks- baseline and intervention period||||percentage of time in bed spent asleep||Standard Deviation|Mean
2579756|NCT02413294|Secondary|Actigraph: Number of Awakenings|Actigraphy counts awakenings by using an accelerometer to assess motion during the night. The number of awakenings is the mean nightly number of awakenings during each of the two-week periods: baseline and intervention.|daily for 4 weeks- baseline and intervention period||||count of awakenings||Standard Deviation|Mean
2579757|NCT02413294|Secondary|Actigraph Sleep Data: Minutes Asleep|mean nightly sleep duration for each of the two-week periods: baseline and intervention|daily for 4 weeks- baseline and intervention period||||minutes||Standard Deviation|Mean
2579758|NCT02413294|Primary|Morningness-Eveningness Questionnaire|The morningness- eveningness categories represent the time of day when a person is at their peak alertness.|two weeks after introduction of intervention||||Participants|||Count of Participants
2579759|NCT02413294|Primary|Insomnia Severity Index Sum Scores|The Insomnia Severity Index measures insomnia severity on a scale from 0 to 28. A score of 15 or higher is indicative of clinical insomnia.|two weeks after introduction of intervention||||units on a scale||Standard Deviation|Mean
2579760|NCT02413294|Primary|Patient Health Questionnaire-9 Depression Scale|The PHQ-9 Depression Scale is a validated scale ranging from 0 to 27 with higher numbers representing greater severity of depressive symptoms, based on 9 questions with each question on a scale of 0 - 3.|two weeks after introduction of intervention||||units on a scale||Standard Deviation|Mean
2579761|NCT02413294|Primary|Pittsburgh Sleep Quality Index|The Pittsburgh Sleep Quality Index is a validated scale which measures self-reported sleep quality based on a wide variety of questions (duration, quality, disturbances, medication, etc.) and converts them to a scale which ranges from 0 to 21 where 6 or higher denotes poor sleep quality.|two weeks after introduction of intervention||||units on a scale||Standard Deviation|Mean
2579762|NCT02413255|Secondary|R: Linearity Index Calculated as AUC24 at Steady State/AUC∞ After a Single Dose for TAK-020 in Part 2 (MRD)||Pre-dose and multiple timepoints (Up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.|||ratio||Standard Error|Least Squares Mean
2579763|NCT02413255|Secondary|Renal Clearance (CLr) for TAK-020 in Part 2 (MRD)|CLr was calculated as (Ae24/AUC24)*100.|Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||L/h||Standard Deviation|Mean
2579764|NCT02413255|Secondary|Renal Clearance (CLr) for TAK-020 in Part 1 (SRD)|CLr was calculated as (Ae96/AUCt)*100.|Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||L/h||Standard Deviation|Mean
2579765|NCT02413255|Secondary|Fe(0-96): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD)|Fe was calculated as (Aet/dose)*100.|Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||percentage of TAK-020 dose||Standard Deviation|Mean
2579766|NCT02413255|Secondary|Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 2 (MRD)|Fe was calculated as (Aet/dose)*100.|Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 1 and Day 9 in Part 2|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||percentage of TAK-020 dose||Standard Deviation|Mean
2579767|NCT02413255|Secondary|Fe(0-24): Fraction of Drug Excreted in Urine for TAK-020 in Part 1 (SRD)|Fe was calculated as (Aet/dose)*100.|Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||percentage of TAK-020 dose||Standard Deviation|Mean
2579768|NCT02413255|Secondary|Ae(0-96): Amount of Drug Excreted in Urine From Time 0 to Time 96 Hours for TAK-020 in Part 1 (SRD)||Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||mg||Standard Deviation|Mean
2579769|NCT02413255|Secondary|Ae(0-24): Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 2 (MRD)|Ae(0-24) is calculated as calculated as Cur*Vur, where Cu was the concentration of drug excreted in urine and Vur is the volume of urine excreted.|Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 1 and Day 9 in Part 2|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||mg||Standard Deviation|Mean
2579770|NCT02413255|Secondary|Ae(0-24) : Amount of Drug Excreted in Urine During a 24-hour Dosing Interval for TAK-020 in Part 1 (SRD)|Ae(0-24) was calculated as calculated as Cur*Vur, where Cur was the concentration of drug excreted in urine and Vur is the volume of urine excreted.|Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||mg||Standard Deviation|Mean
2579771|NCT02413255|Secondary|Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD)|Vz/F was calculated as (CL/F)/λz.|Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||L||Standard Deviation|Mean
2579772|NCT02413255|Secondary|Apparent Volume of Distribution (Vz/F) During the Terminal Disposition Phase After Extravascular Administration Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD)|Vz/F was calculated as (CL/F)/λz.|Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||L||Standard Deviation|Mean
2579773|NCT02413255|Secondary|CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 2 (MRD)|CL/F was calculated as dose/AUCτ.|Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||L/h||Standard Deviation|Mean
2579774|NCT02413255|Secondary|CL/F: Apparent Clearance After Extravascular Administration Calculated Using the Observed Value of the Last Quantifiable Concentration of TAK-020 in Part 1 (SRD)|CL/F was calculated as dose/AUC∞.|Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||L/h||Standard Deviation|Mean
2579775|NCT02413255|Secondary|Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (MRD)||Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||hr||Full Range|Median
2579776|NCT02413255|Secondary|Tlag: Lag Time to First Quantifiable Concentration for TAK-020 (SRD)||Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.|||hr||Full Range|Median
2579777|NCT02413255|Secondary|Lamda z (Λz):Terminal Disposition Phase Rate Constant for TAK-020 (MRD)||From pre-dose to 96 hours post-dose in Part 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||1/hr||Standard Deviation|Mean
2579778|NCT02413255|Secondary|Lambda z (Λz): Terminal Disposition Phase Rate Constant for TAK-020 (SRD)||Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.|||1/hr||Standard Deviation|Mean
2579779|NCT02413255|Secondary|T1/2z : Terminal Disposition Phase Half-life (T1/2z) for TAK-020 in Part 2 (MRD)||Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||hr||Standard Deviation|Mean
2579780|NCT02413255|Secondary|Terminal Disposition Phase Half-life for TAK-020 in Part 1 (SRD)||Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||hr||Standard Deviation|Mean
2579781|NCT02413255|Secondary|Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (MRD)||Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2579782|NCT02413255|Secondary|Cmax/D: Maximum Observed Plasma Concentration Divided by TAK-020 Dose for TAK-020 (SRD)||Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2579783|NCT02413255|Secondary|Rac(Cmax): Accumulation Ratio Based on Cmax Calculated as Cmax at Steady State/Cmax After a Single Dose for TAK-020 (MRD)||Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2579784|NCT02413255|Secondary|Rac(AUC): Accumulation Ratio Based on AUC Calculated as AUC24 at Steady State/AUC24 After a Single Dose for TAK-020 (MRD)||Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2579785|NCT02413255|Secondary|AUC∞:Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 2 (MRD)||Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 in Part 2|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2579786|NCT02413255|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Calculated Using the Observed Value for the Last Quantifiable Concentration for TAK-020 in Part 1 (SRD)||Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2579787|NCT02413255|Secondary|AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 in Part 2 (MRD)||Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2579788|NCT02413255|Secondary|AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t Over the Dosing Interval for TAK-020 (SRD)||Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2579789|NCT02413255|Secondary|AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 2 (MRD)||Pre-dose and multiple timepoints (up to 24 Hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2579790|NCT02413255|Secondary|AUC24/D: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours Divided by TAK-020 Dose for TAK-020 in Part 1 (SRD)||Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.|||ng*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2579791|NCT02413255|Secondary|AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 2 (MRD)||Pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post dose on Day 9 in Part 2|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2579792|NCT02413255|Secondary|AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for TAK-020 in Part 1 (SRD)||Pre-dose and multiple timepoints (up to 24 hours) post-dose in Part 1|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2580455|NCT02406248|Primary|Number of Participants With Bleeding Events (Major and Minor Bleedings)|Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major + minor bleedings|during 1year follow up with ticagrelor treatment||||Participants|||Count of Participants
2579793|NCT02413255|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 2 (MRD)||Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple time-points (up to 24 hours) post dose on Day 9 in Part 2|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||hr||Full Range|Median
2579794|NCT02413255|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-020 in Part 1 (SRD)||Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.|||hr||Full Range|Median
2579795|NCT02413255|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 2 (MRD)||Pre-dose and multiple timepoints (up to 48 hours) post-dose on Day 1 and pre-dose and multiple timepoints (up to 24 hours) post-dose on Day 9 in Part 2|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine. Here, number analyzed are the participants who were evaluated for this outcome measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2579796|NCT02413255|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-020 in Part 1 (SRD)||Pre-dose and multiple timepoints (up to 96 hours) post-dose in Part 1|Pharmacokinetic set included all participants who received study drug and had at least one measurable plasma concentration or amount of drug in the urine.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2579797|NCT02413255|Primary|Percentage of Participants With MAV for Safety ECG Parameters at Least Once Post-dose in Part 2 (MRD)|A standard 12-lead ECG was performed.|From Day 1 to Day 17 in Part 2|Safety Analysis Set included all participants who received study drug.|||percentage of participants|||Number
2579798|NCT02413255|Primary|Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 2 (MRD)|Vital signs include oral temperature respiratory rate, sitting blood pressure (after 5 minutes resting) and pulse (bpm).|From Day 1 to Day 17 in Part 2|Safety Analysis Set included all participants who received study drug.|||percentage of participants|||Number
2579799|NCT02413255|Primary|Percentage of Participants With MAV for Safety Laboratory Findings at Least Once Post-dose in Part 2 (MRD)|Safety laboratory tests include hematology, and serum chemistries.|From Day 1 to Day 17 in Part 2|Safety Analysis Set included all participants who received study drug.|||percentage of participants|||Number
2579800|NCT02413255|Primary|Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 2 Multiple-rising Dose (MRD)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurred or worsened after receiving study drug.|First dose of study drug up to and including 30 days after last dose of study drug (Up to 39 days) in Part 2|Safety Analysis Set was comprised of all participants who received study drug.|||percentage of participants|||Number
2579801|NCT02413255|Primary|Percentage of Participants With MAV for Safety Electrocardiogram (ECG) Parameters at Least Once Post-dose in Part 1 (SRD)|A standard 12-lead ECG was performed. Change from baseline=CFB.|From Day 1 to Day 14 in Part 1|Safety Analysis Set was comprised of all participants who received study drug.|||percentage of participants|||Number
2579802|NCT02413255|Primary|Percentage of Participants With MAV for Vital Sign Measurements at Least Once Post-dose in Part 1 (SRD)|Vital signs include oral temperature, respiratory rate, sitting blood pressure (after 5 minutes resting) and pulse beats per minute (bpm).|From Day 1 to Day 14 of Part 1|Safety Analysis Set was comprised of all participants who received study drug.|||percentage of participants|||Number
2579803|NCT02413255|Primary|Percentage of Participants With Markedly Abnormal Values (MAV) for Safety Laboratory Findings at Least Once Post-dose in Part 1 (SRD)|Safety laboratory tests includes hematology, serum chemistries, and urinalysis.|From Day 1 to Day 14 of Part 1|Safety Analysis Set was comprised of all participants who received study drug.|||percentage of participants|||Number
2579804|NCT02413255|Primary|Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE) in Part 1 Single-rising Dose (SRD)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurred or worsened after receiving study drug.|First dose of study drug up to and including 30 days after last dose of study drug (Up to 31 days) for Part 1|Safety Analysis Set was comprised of all participants who received study drug.|||percentage of participants|||Number
2579805|NCT02413229|Primary|Clinical Response of Success|The proportion of patients in each treatment group that have clinical success at Day 28, which is defined by a Investigator's Global Assessment score of 0 or 1.|28 Days||||Participants|||Count of Participants
2579806|NCT02413203|Secondary|Urinary Lipid Metabolites: TxB2 Metabolite (Tx-M)|Effect of celecoxib on systemic TxB2 was assessed by comparing urine Tx-M in celecoxib vs placebo-treated groups. Urine data are reported as a percentage of the volunteer's own pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents metabolite concentration in ng/mg creatinine.|A single visit of around 4 hours||||percentage of pre-dose control||Standard Deviation|Mean
2579807|NCT02413203|Secondary|Urinary Lipid Metabolites: PGI2 Metabolite (PGI-M)|Effect of celecoxib on systemic PGI2 was assessed by comparing urine PGI-M in celecoxib vs placebo-treated groups. Urine data are reported as a percentage of the volunteer's own pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents metabolite concentration in ng/mg creatinine.|A single visit of around 4 hours||||percentage of pre-dose control||Standard Deviation|Mean
2579808|NCT02413203|Secondary|Celecoxib Plasma Concentration|Celecoxib plasma concentration will be measured in drug-treated and placebo groups by UPLC-MS/MS, and will be expressed as amount of the drug per volume of plasma (ng/ml). At Tmax of 3 hours after a single oral dose of celecoxib of 200 mg, drug plasma concentration should correspond to the maximum plasma concentration or Cmax.|A single visit of around 4 hours||||ng/ml||Standard Deviation|Mean
2580456|NCT02406248|Primary|Number of Participants With Bleeding Events (Major Bleedings)|Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major bleedings|during 1year follow up with ticagrelor treatment||||Participants|||Count of Participants
2579809|NCT02413203|Secondary|Urinary Lipid Metabolites: PGE2 Metabolite (PGE-M)|Effect of celecoxib on systemic PGE2 was assessed by comparing urine PGE-M in celecoxib vs placebo-treated groups. Urine data are reported as a percentage of the volunteer's own pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents metabolite concentration in ng/mg creatinine.|A single visit of around 4 hours||||percentage of pre-dose control||Standard Deviation|Mean
2579810|NCT02413203|Primary|Quantification of Plasma Lipids in the Whole Blood: 15-Hydroxyeicosatetraenoic Acid (15-HETE)|15-HETE in blood taken from celecoxib-treated subjects and stimulated ex vivo with LPS was compared to similarly treated blood from placebo group. Plasma 15-HETE was normalized to sample volume (ng/ml) and expressed as a percentage of subject's pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents 15-HETE concentration in ng/ml.|A single visit of around 4 hours||||percentage of pre-dose control||Standard Deviation|Mean
2579811|NCT02413203|Primary|Quantification of Plasma Lipids in the Whole Blood: Thromboxane B2 (TxB2)|TxB2 in blood taken from celecoxib-treated subjects and stimulated ex vivo with LPS was compared to similarly treated blood from placebo group. Plasma TxB2 was normalized to sample volume (ng/ml) and expressed as a percentage of subject's pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents TxB2 concentration in ng/ml.|A single visit of around 4 hours||||percentage of pre-dose control||Standard Deviation|Mean
2579812|NCT02413203|Primary|Quantification of Plasma Lipids in the Whole Blood: Prostaglandin F2a (PGF2a)|PGF2a in blood taken from celecoxib-treated subjects and stimulated ex vivo with LPS was compared to similarly treated blood from placebo group. Plasma PGF2a was normalized to sample volume (ng/ml) and expressed as a percentage of subject's pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents PGF2a concentration in ng/ml.|A single visit of around 4 hours||||percentage of pre-dose control||Standard Deviation|Mean
2579813|NCT02413203|Primary|Quantification of Plasma Lipids in the Whole Blood: Prostaglandin E2 (PGE2)|PGE2 in blood taken from celecoxib-treated subjects and stimulated ex vivo with LPS was compared to similarly treated blood from placebo group. Plasma PGE2 was normalized to sample volume (ng/ml) and expressed as a percentage of subject's pre-dose control using the formula: percentage of pre-dose control = (Cpost-dose/Cpre-dose) × 100%, where C represents PGE2 concentration in ng/ml.|A single visit of around 4 hours||||percentage of pre-dose control||Standard Deviation|Mean
2579814|NCT02413190|Primary|Bone Mineral Density in FSHD|To determine if bone mineral density is reduced in individuals with FSHD compared to normative data of individuals of the same age and gender without FSHD.The Bone Mineral Density Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population|Single visit|Z score: Higher numbers represent higher bone mineral density.|||z-score||Full Range|Mean
2579815|NCT02413151|Secondary|Changes in Peripheral Artery Tonometry - Reactive Hyperemia (RHI)|Reactive hyperaemia index (RHI) is a functional marker of endothelial dysfunction. The RHI was measured using an EndoPAT recorder.|6 months after CRT implantation||||ratio of the post-to pre occlusion||Inter-Quartile Range|Median
2579816|NCT02413151|Secondary|Changes in 123I-MIBG Cardiac Scintigraphy - Wash Out (WO)|washout provides information on the sympathetic drive. The in-vivo visualization of cardiac innervation is evaluated on planar anterior images, which are acquired early and 3 to 5 hours after tracer injection.|6 months after CRT implantation||||percent change||Inter-Quartile Range|Median
2579817|NCT02413151|Secondary|Changes in 123I-MIBG Cardiac Scintigraphy - Heart-to-mediastinum Ratio (HMR) Late||6 months after CRT implantation||||mGy/MBq||Inter-Quartile Range|Median
2579818|NCT02413151|Secondary|Changes in 123I-MIBG Cardiac Scintigraphy - Heart-to-mediastinum Ratio (HMR) Early||6 months after CRT implantation||||mGy/MBq||Inter-Quartile Range|Median
2579819|NCT02413151|Secondary|Changes in Exercise Testing Variables - Duration of Cardiopulmonary Testing (CPETduration)||6 months after CRT implantation||||seconds||Inter-Quartile Range|Median
2579820|NCT02413151|Secondary|Changes in a Composite Measure of Quality of Life - HeartQoL T Score|HeartQoL scale response of 0-3 (poor-better), higher scores indicate better quality of life. Maximum score: 42 (better prognosis); Minimum score:0 (poor prognosis)|6 months after CRT implantation||||t scores||Inter-Quartile Range|Median
2579821|NCT02413151|Secondary|Changes in Inflammatory Markers - Plasmatic Brain Natriuretic Peptide (BNP)||6 months after CRT implantation||||pg/mL||Inter-Quartile Range|Median
2579822|NCT02413151|Secondary|Changes in Inflammatory Markers - Plasmatic Tumor Necrotic Factor Alpha (TNF-alpha)||6 months after CRT implantation||||µg/ml||Inter-Quartile Range|Median
2579823|NCT02413151|Secondary|Changes in Exercise Testing Variables - Heart Rate Recovery at 1st Minute (HRR1)||6 months after CRT implantation||||bpm||Inter-Quartile Range|Median
2579824|NCT02413151|Primary|Changes in Exercise Testing Variables - Maximum Rate of Oxygen Consumption (VO2peak)||6 months after CRT implantation||||ml/kg/min||Inter-Quartile Range|Median
2579825|NCT02413151|Primary|Changes in Cardiac Function - Left Ventricular Ejection Fraction||6 months after CRT implantation||||percentage of blood eject||Inter-Quartile Range|Median
2579826|NCT02413151|Primary|Changes in a Composite Measure of Clinical Status - New York Heart Association Functional Class|"The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina.~I - Cardiac disease, but no symptoms and no limitation in ordinary physical activity, e.g. no shortness of breath when walking, climbing stairs etc.~II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.~III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).~Comfortable only at rest. IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients."|6 months after CRT implantation||||scores on a scale||Inter-Quartile Range|Median
2580457|NCT02406248|Primary|Number of Participants With Fatal/Life-threatening Bleedings|Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined fatal/life-threatening bleedings|during 1year follow up with ticagrelor treatment||||Participants|||Count of Participants
2579830|NCT02413047|Primary|Eliminate Antibodies: Threshold Levels for ATI is < 3.1and is < 1.7 for ADA.|unwanted immunogenicity is an immune response by an organism against a therapeutic antigen. This reaction leads to production of anti-drug antibodies inactivating the therapeutic effects of the treatment.|4 months|Not enough subjects for analysis||||||
2579831|NCT02413047|Primary|Change Inflammatory Bowel Disease Questionnaire SIBDQ|SIBDQ is the short inflammatory bowel disease questionnaire which is a health-related quality of life tool measuring physical, social, and emotional status.|4 months|Not enough subjects for analysis||||||
2579832|NCT02413047|Primary|Ulcerative Colitis Clinical Score UCCS Decrease >3 Points or Remission Score <3|UCCS is the ulcerative colitis clinical score which is based on disease activity. The score is based on bowel movements, blood in stool, overall well being, and global assessment.|4 months|Not enough subjects for analysis||||||
2579833|NCT02413047|Primary|Therapeutic Trough Level for Infliximab is Defined as >3 and as > 5 for Adalimumab.|Trough level is the lowest level of drug detected in a subject prior to next dose of medication|4 months|Not enough subjects for analysis||||||
2579834|NCT02413047|Primary|Harvey Bradshaw Index HBI: Decrease >3 Points or Remission Score<5|"The Harvey-Bradshaw index (HBI) is a simplified version of the CDAI to foster a systematic collection of clinical data related to Crohn's disease.~The index considers five parameters, exclusively clinical; patient well-being, abdominal pain, number of liquid or soft stools, abdominal mass, and complications."|4 months|Not enough subjects for analysis||||||
2579835|NCT02413034|Primary|Sonication Cultures|Number of positive Sonication cultures (7)|14 days||||cultures|||Number
2579836|NCT02413034|Primary|Positive Cultures|Number of positive Tissue Cultures (7)|14 days||||cultures|||Number
2579837|NCT02413008|Secondary|Changes in Vaginal Maturation Value|"Vaginal cytology sample to evaluate the vaginal Maturation Value. For the cytologic evaluation, the number of parabasal, intermediate and superficial cells will be calculated in duplicate on 100 consecutive cells of vaginal cytology. The average of the two percentages obtained for each cell type will be calculated, which will serve to determine the maturation value (MV) based on the following formula:~0.2 x (% parabasal) + 0.6 x (% intermediate) + 1.0 x (% superficial)."|week 3 and week 12 vs baseline|postmenopausal women|||% of cells||Inter-Quartile Range|Median
2579838|NCT02413008|Secondary|Changes in Total Score of Signs of Vaginal Atrophy Between Week 3 and Week 12 to Baseline|"The signs evaluated Will be the following: vaginal mucosa with flattening of folds or thinning, dryness of the mucosa and Fragility of the mucosa.~It will be scored by the investigator on a numerical scale in accordance with their presence and degree of severity as follows:~0 Absence. The sign is not present.~The sign is present and is considered a mild alteration~The sign is present and is considered a moderate alteration~The sign is present and is considered a severe alteration A Total Signs Score will be calculated by summing the intensities of all the three signs of vaginal atrophy in a certain time point, thus ranging between 0 and 9."|week 3 and week 12 vs baseline|postmenopausal women|||score on a scale||Inter-Quartile Range|Median
2579839|NCT02413008|Secondary|Changes in Vaginal Mucosa With Flattening of Folds or Thinning|"It will be scored by the investigator on a numerical scale in accordance with their presence and degree of severity as follows:~0 Absence. The sign is not present.~The sign is present and is considered a mild alteration~The sign is present and is considered a moderate alteration~The sign is present and is considered a severe alteration"|week 3 and week 12 vs baseline|postmenopausal women|||score on a scale||Inter-Quartile Range|Median
2579840|NCT02413008|Secondary|Changes in Fragility of the Mucosa [Time Frame: Week 3 and Week 12 vs Baseline]|"It will be scored by the investigator on a numerical scale in accordance with their presence and degree of severity as follows:~0 Absence. The sign is not present.~The sign is present and is considered a mild alteration~The sign is present and is considered a moderate alteration~The sign is present and is considered a severe alteration"|from baseline to week 3 and 12|Postmenopausal women|||score on a scale||Inter-Quartile Range|Median
2579841|NCT02413008|Secondary|Changes in Dryness of the Mucosa|"It will be scored by the investigator on a numerical scale in accordance with their presence and degree of severity as follows:~0 Absence. The sign is not present.~The sign is present and is considered a mild alteration~The sign is present and is considered a moderate alteration~The sign is present and is considered a severe alteration"|week 3 and week 12 vs baseline|postmenopausal women|||score on a scale||Inter-Quartile Range|Median
2579842|NCT02413008|Secondary|Changes in Total Score of Symptoms of Vaginal Atrophy|"Changes in Symptoms of vaginal atrophy (vaginal dryness, dyspareunia and pruritus) at week 3 and week 12 vs baseline.~Each symptom will be scored in a numeric scale from 0 to 3, as shown below:~0 Absence. The symptom is not present~The symptom is of mild intensity, without interfering in the patient's activity~The symptom is of moderate intensity, causing obvious discomfort to the patient~The symptom is stated as very irritating and severe in intensity A Global Symptoms Score will be calculated by summing the intensities of all the three symptoms of vaginal atrophy in a certain time point, thus ranging between 0 and 9."|week 3 and week 12 vs baseline|postmenopausal women|||score on a scale||Inter-Quartile Range|Median
2579843|NCT02413008|Secondary|Changes in Vaginal Dryness|"Change in vaginal dryness puntuation score from baseline to w3 and w12~Each symptom will be scored in a numeric scale from 0 to 3, as shown below:~0 Absence. The symptom is not present~The symptom is of mild intensity, without interfering in the patient's activity~The symptom is of moderate intensity, causing obvious discomfort to the patient~The symptom is stated as very irritating and severe in intensity"|week 3 and week 12 vs baseline|postmenopausal women|||units on a scale||Inter-Quartile Range|Median
2579844|NCT02413008|Secondary|Change in Pruritus or Itching From Baseline to Week 3 and Week 12|"Change in pruritus or itching from baseline to week 3 and week 12~Each symptom will be scored in a numeric scale from 0 to 3, as shown below:~0 Absence. The symptom is not present~The symptom is of mild intensity, without interfering in the patient's activity~The symptom is of moderate intensity, causing obvious discomfort to the patient~The symptom is stated as very irritating and severe in intensity"|Change from baseline to week 3 and week 12|postmenopausal women|||units on a scale||Inter-Quartile Range|Median
2579845|NCT02413008|Secondary|Changes in Dyspareunia|"Changes in dyspareunia from baseline to week 3 and week 12 Each symptom will be scored in a numeric scale from 0 to 3, as shown 0 Absence. The symptom is not present~The symptom is of mild intensity, without interfering in the patient's activity~The symptom is of moderate intensity, causing obvious discomfort to the patient~The symptom is stated as very irritating and severe in intensity"|week 3 and week 12 vs baseline|postmenopausal women|||score on a scale||Inter-Quartile Range|Median
2579850|NCT02413008|Secondary|Variation in Serum Levels of Luteinizing Hormone (LH)|Change from (mean screening-baseline) in plasma levels of LH to Week 1, Week 3, Week 8 and Week 12 in Serum Levels of LH compare to natural physiological variability ( screening-baseline variation)|Change from baseline to week 1, week 3, week 8 and week 12|postmenopausal women|||mIU/ml||Inter-Quartile Range|Median
2579851|NCT02413008|Secondary|Variation in Serum Levels of FSH at Week 1, Week 3 and Week 8|Change from Baseline (mean screening-baseline) to Week 1, Week 3 and Week 8 in Serum Levels of Follicle Stimulating Hormone (FSH) compare to natural physiological variability ( screening-baseline variation)|Change from baseline to week 1, week 3 and week 8|postmenopausal women|||mIU/ml||Inter-Quartile Range|Mean
2579852|NCT02413008|Primary|Variation in Serum Levels of Follicle Stimulating Hormone (FSH)|Change from Baseline (mean screening-baseline) to Week 12 in Serum Levels of Follicle Stimulating Hormone (FSH) compare to natural physiological variability (screening-baseline variation)|from baseline to 12 weeks of treatment|postmenopausal participants|||mIU/ml||Inter-Quartile Range|Median
2579853|NCT02412878|Secondary|Plasma Carfilzomib Concentration During Cycle 2|Concentrations of carfilzomib in plasma were measured using a validated assay method. The lower limit of quantification was 0.100 ng/mL.|Cycle 2 day 1 predose, 15 minutes after the start of infusion (once-weekly carfilzomib only), end of infusion, and 30 minutes after the end of infusion|Participants at a subset of sites who participated in the sparse pharmacokinetic sampling, with available data at each time point.|||ng/mL||Standard Deviation|Mean
2579854|NCT02412878|Secondary|Number of Participants With Adverse Events (AEs)|"The severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03, where where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Fatal.~Treatment-related adverse events are adverse events considered related to at least 1 investigational product by the investigator, including those with unknown relationship."|From first dose of study drug up to 30 days after last dose, up to the end of study; median (minimum, maximum) duration of treatment was 29.1 (0.1, 156.3) weeks and 38.0 (0.1, 158.3) weeks in each treatment group respectively.|All participants who received at least 1 dose of study drug|||Participants|||Count of Participants
2579855|NCT02412878|Secondary|Overall Survival|"Overall Survival (OS) was defined as the time from randomization to death due to any cause.~Median overall survival was derived using the Kaplan-Meier method; participants still alive were censored at the date last known to be alive."|From randomization until the data cut-off date of 15 June 2017; median (minimum, maximum) follow-up time for OS was 12.6 (0, 20) and 13.2 (0, 19) months in each treatment group respectively.|Intent-to-treat population|||months||95% Confidence Interval|Median
2579856|NCT02412878|Primary|Progression Free Survival|"Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause.~Disease status was assessed at a central laboratory with serum and urine protein electrophoresis, immunofixation, serum-free light chain (SFLC) assay, bone marrow sample evaluation, serum calcium, plasmacytoma evaluation, and skeletal survey. Response and disease progression were determined using a validated computer algorithm based on the International Myeloma Working Group—Uniform Response Criteria (IMWG-URC).~Median PFS was derived using the Kaplan-Meier method; participants still alive with no disease progression were censored at the time of their last disease assessment."|From randomization until the data cut-off date of 15 June 2017; median (minimum, maximum) follow-up time for PFS was 12.0 (0, 20) and 12.6 (0, 19) months in each treatment group respectively.|Intent-to-treat population|||months||95% Confidence Interval|Median
2579857|NCT02412878|Secondary|Overall Response Rate|"Disease response was evaluated according to the IMWG-URC using a validated computer algorithm. Overall response rate was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).~sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).~CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.~PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline."|Disease response was assessed every 28 days until progressive disease, up to the data cut-off date of 15 June 2017; median time on follow-up was 12.0 and 12.6 months in each treatment group respectively.|Intent-to-treat population|||percentage of participants||95% Confidence Interval|Number
2579858|NCT02412852|Secondary|Assessment of Blood Oxygenation. (Pulse Oximetry)|Pulse oximetry will be used at each visit to determine whether treatment improves oxygen levels in the blood.|12 weeks|Oxygen saturation was measured at baseline, V2 and V3.|||% Oxygenation||Standard Deviation|Mean
2579859|NCT02412852|Secondary|Assessment of Diabetes. (HbA1C Levels)|HbA1C levels will be monitored at each visit to determine whether treatment reduces circulating glucose levels.|12 weeks|HbA1c blood levels were analyzed at baseline, V2 and V3|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2579860|NCT02412852|Secondary|Clinical Assessment of Pain. (Quantitative Sensory Testing)|Quantitative sensory testing (QST) was conducted at each visit to determine patients sensitivity to pain. QST was assessed using a quantitative nerve conductance machine where nerves in the distal extremity are subjected to electrical stimulation to determine the sensory threshold of the skin. Nerve conductance measures how fast an electrical impulse moves through the nerve, and nerve velocity measures the speed at which an electrical impulse moves down a neuronal pathway.|12 weeks|Analyzed only the subjects that completed testing.|||meters per second||Standard Deviation|Mean
2579872|NCT02412722|Secondary|Geometric Mean Ratio of Cmax: Maximum Observed Plasma Concentration of Sapanisertib Milled Versus Unmilled API Capsules Under Fasted Conditions||Days 1 and 3 pre-dose and at multiple time points (up to 24 hours) post-dose|PK population included participants with protocol specified dosing and conditions and PK data to reliably estimate PK parameters.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2579906|NCT02412501|Primary|Number of Participants With Target Lesion Failure at 12 Months Post-Procedure|Target Lesion Failure at 12 months post-procedure, defined as Cardiac Death, Target Vessel Myocardial Infarction (Q wave or non-Q wave) or Target Lesion Revascularization by percutaneous or surgical methods.|12 Months||||Participants|||Count of Participants
2579861|NCT02412852|Secondary|Assessment of Patients Reported Pain Through Composite Analysis of Pain Questionaires.|Subjects completed the Brief pain inventory (BPI), RAND 36 questionnaire, neuropathic pain symptom inventory (NPSI) and Short Form McGill Pain Questionnaire at each visit for these self-reported questionnaires. The BPI is a questionnaire that measures the patient's subjective perception of pain, its exacerbating and alleviating factors, and perceived effect on functional status; the NPSI is a questionnaire that measures the symptoms associated with neuropathic pain; the Short Form McGill Questionnaire subjectively assesses the patients perception of pain described by commonly used adjectives associated with pain. NPSI is average of 12 questions, range from 0 (no pain) to 120 (maximal pain); For BPI severity and interference, questions are scored from 0-10, then there average score for each subsection is calculated (the higher the score, the worse the response); Scores on McGill range from 0-10, lower associated for less pain, then averaged for each sub score and total score.|Baseline (visit 1) and 12 weeks (visit 3)|NPS is a sum of total scores, McGill and BPI an average of the scores for each question.|||units on a scale||Full Range|Mean
2579862|NCT02412852|Secondary|The Number of Participants Who Reported Use of Analgesic or Medications for Neuropathic Pain.|Daily patient reported use of analgesic or medications for neuropathic pain. The use of medications were recorded at the baseline visit and during both the intermediate and final visit for each subject. All subjects used at least one prescription pain medication, other than one subject in the 80-mg dose cohort who used only ibuprofen to control pain. Most subjects used more than one prescription pain medication. There was no change in use of pain medications during the trial period.|12 weeks|Analyzed only those subjects who completed 12 weeks of testing.|||Participants|||Count of Participants
2579863|NCT02412852|Secondary|Pharmacokinetics (Blood Levels of Nitrite)|Blood levels of nitrite will be assessed for 6 hours post-administration on the initial dosing visit.|1 day|All subjects who were randomized.|||ng/ml||Standard Deviation|Mean
2579864|NCT02412852|Primary|Reporting of Adverse Events During 12 Week Study Period|The primary objective of this clinical study is to evaluate the safety and tolerability of multiple doses of twice daily 40mg and 80mg sustained release sodium nitrite compared with placebo over a 12 week treatment period. The following safety parameters will also be assessed: concomitant medication usage, physical examination, vital signs, Comprehensive Metabolic Panel, and complete blood count. Assessment of acute adverse events (i.e., drop in blood pressure, dizziness) after administration of each dose level. Counts are number of subjects reporting at least 1 Adverse Event. The total Adverse Events recorded in each cohort is also reported.|12 weeks|Randomized population including dropouts.|||Adverse Events|||Number
2579865|NCT02412761|Primary|The Number of Patients for Whom Each Drug is Selected as the Preferred Therapy|For each n-of-1 trial, the preferred drug is defined as that which produces normal ambulatory blood pressure (by pediatric Ambulatory blood pressure monitoring (ABPM) standards), with the greatest magnitude of wake mean systolic BP reduction, and without unacceptable side effects.|The outcome of BP control and side effect tolerability will be assessed 2 weeks after starting each drug. Participants will be followed for an average of 10-12 weeks.||||Participants|||Count of Participants
2579866|NCT02412722|Secondary|Change From Baseline in Tumor Volume/Size|Changes in tumor size and volume will be determined by measurements from computed tomography (CT) and magnetic resonance imaging (MRI) scans.|From Cycle 1 Day -14 to 14 months|Data was not collected for this outcome measure.||||||
2579867|NCT02412722|Secondary|Clinical Benefit Response (CBR)|CBR is defined as the percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions. SD is neither shrinkage by greater than or equal to 30% of the sum of the longest diameter of target lesions or the increase of lesions by greater than or equal to 20% of the sum of the longest diameter of target lesions.|Baseline then every 2 cycles beginning at Cycle 3, Day 1, until disease progression, death or end of study (Up to 14 months)|Safety population included participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2579868|NCT02412722|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from the date of first study drug administration to the date of first documented PD or death due to any cause. PD was based on response evaluation criteria in solid tumors (RECIST V1.1), defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline then every 2 cycles beginning at Cycle 3, Day 1, until disease progression, death or end of study (Up to 14 months)|Data was not collected for this outcome measure.||||||
2579869|NCT02412722|Secondary|Overall Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST)|ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.|Baseline then every 2 cycles beginning at Cycle 3, Day 1, until disease progression, death or end of study (Up to 14 months)|Safety population included participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2579870|NCT02412722|Secondary|AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Sapanisertib Milled Versus Unmilled API Capsules Under Fasted Conditions||Days 1 and 3 pre-dose and at multiple time points (up to 24 hours) post-dose|PK population included participants with protocol specified dosing and conditions and PK data to reliably estimate PK parameters. Overall number of participants analyzed is the number of participants with the data available for this outcome measure.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2579871|NCT02412722|Secondary|Geometric Mean Ratio of AUC(0-last): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration for Sapanisertib Milled Versus Unmilled API Capsules Under Fasted Conditions||Days 1 and 3 pre-dose and at multiple time points (up to 24 hours) post-dose|PK population included participants with protocol specified dosing and conditions and PK data to reliably estimate PK parameters.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2579873|NCT02412722|Primary|AUC(0-8): Area Under the Plasma Concentration Curve From Time Zero to 8 Hours Post-dose for Sapanisertib Milled API Capsules Under Fasted Conditions Approximately 24 Hours After Paclitaxel Infusion||Cycle 1, Day 2 pre-dose and at multiple time points (up to 8 hours) post-dose|PK population included participants with protocol specified dosing and conditions and PK data to reliably estimate PK parameters.|||ng*hr/mL||Standard Deviation|Mean
2579874|NCT02412722|Primary|Tmax: Time to Reach the Maximum Plasma Concentration of Sapanisertib Milled API Capsules Under Fasted Conditions Approximately 24 Hours After Paclitaxel Infusion||Cycle 1, Day 2 pre-dose and at multiple time points (up to 8 hours) post-dose|PK population included participants with protocol specified dosing and conditions and PK data to reliably estimate PK parameters.|||hours||Full Range|Median
2579875|NCT02412722|Primary|Cmax: Maximum Observed Plasma Concentration of Sapanisertib Milled API Capsules Under Fasted Conditions Approximately 24 Hours After Paclitaxel Infusion||Cycle 1, Day 2 pre-dose and at multiple time points (up to 8 hours) post-dose|PK population included participants with protocol specified dosing and conditions and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Mean
2579876|NCT02412722|Primary|Geometric Mean Ratio of AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Sapanisertib Milled API Capsules Under Fasted and Fed Conditions||Days 3 and 5 predose and at multiple time points (up to 24 hours) post-dose|PK population included participants with protocol specified dosing and conditions and PK data to reliably estimate PK parameters. Overall number of participants analyzed is the number of participants with the data available for this outcome measure.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2579877|NCT02412722|Primary|Geometric Mean Ratio of AUC(0-last): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of Sapanisertib Milled API Capsules Under Fasted and Fed Conditions||Days 3 and 5 predose and at multiple time points (up to 24 hours) post-dose|PK population included participants with protocol specified dosing and conditions and PK data to reliably estimate PK parameters.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2579878|NCT02412722|Primary|Geometric Mean Ratio of Cmax: Maximum Observed Plasma Concentration of Sapanisertib Milled Active Pharmaceutical Ingredient (API) Capsules Under Fasted and Fed Conditions||Days 3 and 5 predose and at multiple time points (up to 24 hours) post-dose|PK population included participants with protocol specified dosing and conditions and PK data to reliably estimate PK parameters.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2579879|NCT02412722|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|From Day 1, Cycle 1 through 30 days after the last dose of study drug (up to 15 months)|Safety population included participants who received at least 1 dose of study drug. PK-Run In population included participants who received more than one dose of study drug in PK Run-In period.|||Participants|||Count of Participants
2579880|NCT02412657|Secondary|Patients Overall Satisfaction|categorical data (1: very satisfied, would recommend this analgesia protocol to others, 0: not satisfied, would not recommend this analgesia protocol to others|48 hours|||||||
2579881|NCT02412657|Secondary|Sleep Disturbance|Sleep disturbance scale 0-10 (0: no sleep disturbance from pain, 10: worst conceivable sleep disruption from pain)|24 hours and 48 hours|||||||
2579882|NCT02412657|Secondary|Residual Motor Block|Scale of 0-2 (0:inability to move fingers, 1: fingers able to move, with diminished strength compared to non operated side, 2: No motor weakness of the fingers)|24 hours and 48 hours|||||||
2579883|NCT02412657|Secondary|Pain Scores|On a 11-points Verbal Numeric Scale 0-10 (0= no pain, 10= worst conceivable pain)|every 6 hours during the first 48 hours after surgery|||||||
2579884|NCT02412657|Primary|Duration of Analgesia|Defined as the time between the performance of the block and the first analgesic request|48 hours after surgery||||hours||Inter-Quartile Range|Median
2579885|NCT02412644|Secondary|Number of Subjects Achieving Physician Global Assessment Score of 0 or 1 at Week 36|PGA score 0 or 1|36 weeks||||participants|||Number
2579886|NCT02412644|Secondary|Number of Subjects Achieving Psoriasis Area Severity Index Score 90 at Week 36|PASI 90 or greater at week 36|36 weeks||||participants|||Number
2579887|NCT02412644|Secondary|Number of Subjects Achieving Psoriasis Area Severity Index Score (PASI) 75 Response at Week 12|Psoriasis Area Severity Score of 75 or greater at week 12|12WEEKS|22 subjects completed week 12|||participants|||Number
2579888|NCT02412644|Primary|Number of Participants Maintaining Psoriasis Area Severity Index Score (PASI) 75 at Week 36|Analysis of Psoriasis Area Severity Index Score at week 36 to determine number of subjects who maintained PASI 75 at week 36|36weeks||||participants|||Number
2579889|NCT02412501|Secondary|Number of Participants With Stent Thrombosis (ST) at 36 Months Post Procedure||36 Months||||Participants|||Count of Participants
2579890|NCT02412501|Secondary|Number of Participants With Target Vessel Failure (TVF) at 36 Months Post Procedure||36 Months||||Participants|||Count of Participants
2579891|NCT02412501|Secondary|Number of Participants With a Major Adverse Cardiac Event at 36 Months Post Procedure||36 Months||||Participants|||Count of Participants
2579892|NCT02412501|Secondary|Number of Participants With Target Vessel Myocardial Infarction (TVMI) at 36 Months Post Procedure|TVMI defined as Q Wave or non-Q Wave MI|36 Months||||Participants|||Count of Participants
2579893|NCT02412501|Secondary|Number of Participants With Cardiac Death at 36 Months Post Procedure||36 Months||||Participants|||Count of Participants
2579894|NCT02412501|Secondary|Number of Participants With Target Lesion Failure (TLF) at 36 Months Post Procedure||36 Months||||Participants|||Count of Participants
2579907|NCT02412488|Primary|Number of Participants With Untoward Events|"An untoward event is a composite endpoint defined as a LINQTM or LINQTM insertion procedure related complication OR an unsuccessful LINQTM insertion procedure, where a LINQTM or LINQTM insertion procedure related complication is defined as an adverse event related to the LINQTM or a LINQTM insertion procedure resulting in:~Death~Termination of significant device function~Invasive intervention (e.g. includes LINQTM revision/explant for reasons other than diagnosis of underlying condition, intravenous drug administration)"|3 months|Subjects exiting prematurely (prior to 3-month visit) without an untoward event were excluded from the primary analysis. There were 15 subjects exited prior to the 3-month visit all due to premature exit without having an untoward event|||Participants|||Count of Participants
2579908|NCT02412436|Secondary|Time at Which Participant-specific Estimated Elimination Slopes for DMPA Level Cross the Threshold of 0.1 ng/mL|Describe the time at which DMPA levels drop below the threshold of 0.1 ng/mL, based on participant-specific estimated elimination slopes from nonlinear mixed-effects (NLME) models. The Week 0 time point was drawn prior to DMPA injection.|Weeks 0, 2, 4, 6, 8, 10, and 12|Participants who did not have DMPA concentrations at weeks 10 and 12 were excluded from the analysis.|||days||Inter-Quartile Range|Median
2579909|NCT02412436|Secondary|DMPA Half-life|Describe the terminal elimination half-life of DMPA (t½) between 0 and 12 weeks, where t½ was calculated using nonlinear mixed-effects (NLME) modelling. The Week 0 time point was drawn prior to DMPA injection.|Weeks 0, 2, 4, 6, 8, 10, and 12|Participants who did not have DMPA concentrations at weeks 10 and 12 were excluded from the analysis.|||hours||Inter-Quartile Range|Median
2579910|NCT02412436|Secondary|Percent of Participants Who Experienced a Grade 3 or Higher Sign/Symptom or Laboratory Abnormality|The percent of participants who experienced a grade 3 (severe) or higher sign/symptom or laboratory abnormality were calculated with an exact Clopper-Pearson 95% confidence interval. Events were graded (1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death) according to the DAIDS AE Grading Table (V1.0).|Weeks 2, 4, 6, 8, 10, and 12|All enrolled participants were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2579911|NCT02412436|Secondary|DMPA CL/F|Describe the apparent DMPA clearance (CL/F) between 0 and 12 weeks. The Week 0 time point was drawn prior to DMPA injection.|Weeks 0, 2, 4, 6, 8, 10, and 12|Participants who did not have DMPA concentrations at weeks 10 and 12 were excluded from the analysis.|||L/week||Inter-Quartile Range|Median
2579912|NCT02412436|Secondary|DMPA Cmax|Describe the DMPA maximum observed concentration (Cmax) between 0 and 12 weeks. The Week 0 time point was drawn prior to DMPA injection.|Weeks 0, 2, 4, 6, 8, 10, and 12|Participants who did not have DMPA concentrations at weeks 10 and 12 were excluded from the analysis.|||ng/mL||Inter-Quartile Range|Median
2579913|NCT02412436|Secondary|DMPA Cmin|Describe the DMPA minimum observed concentration (Cmin) between 0 and 12 weeks. The Week 0 time point was drawn prior to DMPA injection.|Weeks 0, 2, 4, 6, 8, 10, and 12|Participants who did not have DMPA concentrations at weeks 10 and 12 were excluded from the analysis.|||ng/mL||Inter-Quartile Range|Median
2579914|NCT02412436|Secondary|DMPA AUC|Describe the DMPA plasma area under the curve (AUC) between 0 and 12 weeks, where AUC(0-12wks) was calculated using non-compartmental methods.The Week 0 time point was drawn prior to DMPA injection.|Weeks 0, 2, 4, 6, 8, 10, and 12|Participants who did not have DMPA concentrations at weeks 10 and 12 were excluded from the analysis.|||ng*week/mL||Inter-Quartile Range|Median
2579915|NCT02412436|Secondary|Cumulative Percentage of Participants With DMPA < 0.1 ng/mL|The cumulative percentage of participants having a DMPA concentration less than 0.1 ng/mL at week 12 was calculated using a Kaplan-Meier estimator with an associated standard error. The confidence interval was calculated using a log-log transformation. Suppression of ovulation generally occurs as long as the DMPA level is => 0.1 ng/mL.|Weeks 0, 2, 4, 6, 8, 10, and 12|Participants who did not have DMPA concentrations at weeks 10 and 12 were excluded from the analysis.|||cumulative percentage of participants||95% Confidence Interval|Number
2579916|NCT02412436|Secondary|Percent of Participants With DMPA Concentrations Below 0.1 ng/mL at Weeks 2, 4, 6, 8, and 10|The percents of participants with plasma DMPA concentrations below 0.1 ng/mL at weeks 2, 4, 6, 8, and 10 were calculated with exact Clopper-Pearson 95% confidence intervals. Suppression of ovulation generally occurs as long as the DMPA level is => 0.1 ng/mL.|Weeks 2, 4, 6, 8, and 10|Participants who did not have a DMPA concentration at the analysis week of interest were excluded from each analysis as appropriate. For example, participants missing a DMPA concentration at week 4 were excluded from the week 4 analysis.|||percentage of participants||95% Confidence Interval|Number
2579917|NCT02412436|Primary|Percent of Participants With Progesterone Levels Above 1 ng/mL at Week 12|The percent of participants with plasma progesterone levels above 1 ng/mL was calculated with an exact Clopper-Pearson 95% confidence interval. Ovulation generally occurs when the progesterone level is > 5 ng/mL. If there were participants with plasma progesterone levels > 1 ng/mL, then the percent of participants with plasma progesterone levels > 5 ng/mL would have been calculated by study week.|Week 12|Participants who did not have progesterone concentrations at weeks 10 and 12 were excluded from the analysis.|||percentage of participants||95% Confidence Interval|Number
2579918|NCT02412436|Primary|Percent of Participants With DMPA Concentrations Below 0.1 ng/mL at Week 12|The percent of participants with plasma DMPA concentrations below 0.1 ng/mL was calculated with an exact Clopper-Pearson 95% confidence interval. Suppression of ovulation generally occurs as long as the DMPA level is => 0.1 ng/mL.|Week 12|Participants who did not have DMPA concentrations at weeks 10 and 12 were excluded from the analysis|||percentage of participants||95% Confidence Interval|Number
2579919|NCT02412306|Secondary|Expansion Cohort Pediatric: Percentage of Participants With M1 Remission Within 2 Cycles of Treatment|M1 remission for pediatric participants was defined as ≤ 5% blasts (M1 bone marrow) in the bone marrow and no evidence of disease.|Within the first 2 cycles of treatment, 12 weeks|Expansion Cohort pediatric participants who received any infusion of blinatumomab.|||percentage of participants||95% Confidence Interval|Number
2579943|NCT02412111|Secondary|Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolites (M1-VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)||Predose on Week -2 for Run-in period; Pre-dose on Week 2 for Active comparator period|"Pharmacokinetic (PK) set included participants who received study drug and had PK assessment. Here 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome. Number Analyzed=0 indicates no participants were analyzed for specified categories because VX-661 was not administered in the specified arms."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2579920|NCT02412306|Secondary|Expansion Cohort Adult: Percentage of Participants With a Best Response of Complete Remission or Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment|"Hematological assessments were performed from bone marrow biopsy samples. All hematological assessments of bone marrow were reviewed in a central reference laboratory.~Hematological remissions were defined by the following criteria:~Complete Remission (CR) is defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts: platelets > 100,000/µl and absolute neutrophil count (ANC) > 1,000/µl.~Complete Remission With Partial Hematological Recovery (CRh*) is defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts: platelets > 50,000/µl and ANC > 500/µl."|Within the first 2 cycles of treatment, 12 weeks|Expansion Cohort adult participants who received any infusion of blinatumomab.|||percentage of participants||95% Confidence Interval|Number
2579921|NCT02412306|Primary|Expansion Cohort: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs|"TEAEs are defined as those that start between the start of the first infusion of blinatumomab and 30 days after the end of the last infusion during the treatment period.~The severity of adverse events was assessed by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 as follows: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death.~The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab."|From the start of the first infusion to 30 days after the end of the last infusion; median (min, max) treatment duration was 55.6 (25, 140) and 28.0 (8, 56) days in the adult and pediatric expansion cohorts, respectively.|Expansion Cohort participants in the who received any infusion of blinatumomab.|||participants|||Number
2579922|NCT02412306|Secondary|Phase 1b and Phase 2: Interferon Gamma (IFN-γ) Concentration|"The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-6, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN-γ) using multiplex cytometric bead assays. The lower limit of quantification (LLOQ) was 125 pg/mL and the limit of detection (LOD) was 20 pg/mL.~For calculations of mean cytokine concentrations at every time point across all participants, samples with concentrations below LLOQ were included in the calculation as ½ LLOQ (= 62.5 pg/mL); samples with values below LOD were included as ½ LOD (= 10 pg/mL)."|Adults: cycle 1, day 1: 2, 6, 10, 24 hrs after infusion start; day 8: 2, 6, 10 hrs after dose step. Cycles 2-5, day 1: 6 hrs after infusion start. Pediatric: cycle 1, day 1: 6, 10, 24 hrs after infusion start; Cycles 2-5, day 1: 6 hrs after infusion start|Phase 1b participants who received any infusion of blinatumomab and had at least one pharmacodynamic sample collected, with available data at each time point.|||pg/mL||Standard Deviation|Mean
2579923|NCT02412306|Secondary|Phase 1b and Phase 2: Tumor Necrosis Factor-Alpha (TNFα) Concentration|"The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-6, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN-γ) using multiplex cytometric bead assays. The lower limit of quantification (LLOQ) was 125 pg/mL and the limit of detection (LOD) was 20 pg/mL.~For calculations of mean cytokine concentrations at every time point across all participants, samples with concentrations below LLOQ were included in the calculation as ½ LLOQ (= 62.5 pg/mL); samples with values below LOD were included as ½ LOD (= 10 pg/mL)."|Adults: cycle 1, day 1: 2, 6, 10, 24 hrs after infusion start; day 8: 2, 6, 10 hrs after dose step. Cycles 2-5, day 1: 6 hrs after infusion start. Pediatric: cycle 1, day 1: 6, 10, 24 hrs after infusion start; Cycles 2-5, day 1: 6 hrs after infusion start|Phase 1b and phase 2 participants who received any infusion of blinatumomab and had at least one pharmacodynamic sample collected, with available data at each time point.|||pg/mL||Standard Deviation|Mean
2579924|NCT02412306|Secondary|Phase 1b and Phase 2: Interleukin-10 Concentration|"The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-6, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN-γ) using multiplex cytometric bead assays. The lower limit of quantification (LLOQ) was 125 pg/mL and the limit of detection (LOD) was 20 pg/mL.~For calculations of mean cytokine concentrations at every time point across all participants, samples with concentrations below LLOQ were included in the calculation as ½ LLOQ (= 62.5 pg/mL); samples with values below LOD were included as ½ LOD (= 10 pg/mL)."|Adults: cycle 1, day 1: 2, 6, 10, 24 hrs after infusion start; day 8: 2, 6, 10 hrs after dose step. Cycles 2-5, day 1: 6 hrs after infusion start. Pediatric: cycle 1, day 1: 6, 10, 24 hrs after infusion start; Cycles 2-5, day 1: 6 hrs after infusion start|Phase 1b and phase 2 participants who received any infusion of blinatumomab and had at least one pharmacodynamic sample collected, with available data at each time point.|||pg/mL||Standard Deviation|Mean
2579925|NCT02412306|Secondary|Phase 1b and Phase 2: Interleukin-6 Concentration|"The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-6, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN-γ) using multiplex cytometric bead assays. The lower limit of quantification (LLOQ) was 125 pg/mL and the limit of detection (LOD) was 20 pg/mL.~For calculations of mean cytokine concentrations at every time point across all participants, samples with concentrations below LLOQ were included in the calculation as ½ LLOQ (= 62.5 pg/mL); samples with values below LOD were included as ½ LOD (= 10 pg/mL)."|Adults: cycle 1, day 1: 2, 6, 10, 24 hrs after infusion start; day 8: 2, 6, 10 hrs after dose step. Cycles 2-5, day 1: 6 hrs after infusion start. Pediatric: cycle 1, day 1: 6, 10, 24 hrs after infusion start; Cycles 2-5, day 1: 6 hrs after infusion start|Phase 1b and phase 2 participants who received any infusion of blinatumomab and had at least one pharmacodynamic sample collected, with available data at each time point.|||pg/mL||Standard Deviation|Mean
2579944|NCT02412111|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)||Baseline up to Week 16|The Safety Set included all participants who received at least 1 dose of study drug during Ivacaftor (Run-in period) and active comparator treatment period.|||Participants|||Number
2579945|NCT02412111|Secondary|Absolute Change From Baseline in Sweat Chloride Through Week 8|Sweat samples were collected using an approved collection device.|Baseline, Through Week 8|"Full Analysis Set was defined as all randomized participants who have received at least 1 dose of blinded study drug during the active comparator treatment period. Here Overall number of participants analyzed signifies those participants who were evaluable for this outcome."|||Millimoles per liter||Standard Error|Least Squares Mean
2579926|NCT02412306|Secondary|Phase 1b and Phase 2: Interleukin-2 Concentration|"The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-6, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN-γ) using multiplex cytometric bead assays. The lower limit of quantification (LLOQ) was 125 pg/mL and the limit of detection (LOD) was 20 pg/mL.~For calculations of mean cytokine concentrations at every time point across all participants, samples with concentrations below LLOQ were included in the calculation as ½ LLOQ (= 62.5 pg/mL); samples with values below LOD were included as ½ LOD (= 10 pg/mL)."|Adults: cycle 1, day 1: 2, 6, 10, 24 hrs after infusion start; day 8: 2, 6, 10 hrs after dose step. Cycles 2-5, day 1: 6 hrs after infusion start. Pediatric: cycle 1, day 1: 6, 10, 24 hrs after infusion start; Cycles 2-5, day 1: 6 hrs after infusion start|Phase 1b and phase 2 participants who received any infusion of blinatumomab and had at least one pharmacodynamic sample collected, with available data at each time point.|||pg/mL||Standard Deviation|Mean
2579927|NCT02412306|Secondary|Phase 1b and Phase 2: Number of Participants Who Developed Anti-Blinatumomab Antibodies|Antibodies to blinatumomab were detected using an electrochemiluminescence (ECL)-based assay.|Day 1 before first dose; cycles 1 and 2 day 29, 6 hours after end of infusion; 30 days after last dose.|Phase 1b and Phase 2 participants who received any infusion of blinatumomab.|||Participants|||Count of Participants
2579928|NCT02412306|Secondary|Phase 1b and Phase 2: Volume of Distribution of Blinatumomab||Cycle 1 day 1 predose, 2, 6 (adults), 10, 24 hours; day 8 (prior to dose step) 0 hour (adults); day 15 any time during infusion; day 29 prior to end of infusion, 1 (adults), 2, 4 (adults), 6 hours after end of infusion|Phase 1b and phase 2 participants who received any infusion of blinatumomab and had at least one pharmacokinetic sample collected with available data.|||liters||Standard Deviation|Mean
2579929|NCT02412306|Secondary|Phase 1b and Phase 2: Terminal Half-life of Blinatumomab||Cycle 1 day 1 predose, 2, 6 (adults), 10, 24 hours; day 8 (prior to dose step) 0 hour (adults); day 15 any time during infusion; day 29 prior to end of infusion, 1 (adults), 2, 4 (adults), 6 hours after end of infusion|Phase 1b and phase 2 participants who received any infusion of blinatumomab and had at least one pharmacokinetic sample collected with available data.|||hours||Standard Deviation|Mean
2579930|NCT02412306|Secondary|Phase 1b and Phase 2: Systemic Clearance of Blinatumomab|Systemic clearance (CL) was calculated as CL = R0/Css, where R0 is the infusion rate (µg/hour or µg/m²/hour).|After 24 hours from the start of infusion: Cycle 1 (before dose step) day 2; Cycle 1 (after dose step) days 15 and 29; Cycle 2 onwards day 8 (pediatric and adult), days 15 and 29 (adult).|Phase 1b and phase 2 participants who received any infusion of blinatumomab and had at least one pharmacokinetic sample collected.|||liters/hour||Standard Deviation|Mean
2579931|NCT02412306|Secondary|Phase 1b and Phase 2: Serum Blinatumomab Concentration at Steady State|"The steady-state concentration (Css) of serum blinatumomab was summarized as the average of the observed concentrations collected after 5 half-lives or after 24 hours from the start of continuous IV infusion.~Cycle 1, day 2 values represent steady-state concentration after CIV with the initial dose of blinatumomab (9 µg/day for adults and 5 µg/m²/day for pediatric patients). All other time points were measured after the dose step to 28 µg/day (adults) / 15 µg/m²/day (pediatric participants)."|After 24 hours from the start of infusion: Cycle 1 (before dose step) day 2; Cycle 1 (after dose step) days 15 and 29; Cycle 2 onwards day 8 (pediatric and adult), days 15 and 29 (adult).|Phase 1b and phase 2 participants who received any infusion of blinatumomab and had at least one pharmacokinetic sample collected, with available data at each time point.|||pg/mL||Standard Deviation|Mean
2579932|NCT02412306|Secondary|Phase 1b and Phase 2: Number of Participants With TEAEs|"TEAEs are defined as those that start between the start of the first infusion of blinatumomab and 30 days after the end of the last infusion during the treatment period.~The severity of adverse events was assessed by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 as follows: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death.~The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab."|From the start of the first infusion to 30 days after the end of the last infusion; median (min, max) treatment duration was 108 (56, 140), 56.0 (5, 84), and 56.0 (11, 115) days in adult phase 1b, adult phase 2 and pediatric phase 1b cohort respectively.|Phase 1b and Phase 2 participants who received any infusion of blinatumomab.|||Participants|||Count of Participants
2579933|NCT02412306|Secondary|Phase 2: 100-Day Mortality After Allogeneic HSCT|"The analysis of 100-day mortality after allogeneic HSCT was assessed for all participants who received an allogeneic HSCT while in any CR following treatment with blinatumomab. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT.~Participants still alive alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive.~The 100-day mortality rate after allogeneic HSCT was defined as the percentage of participants having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods."|100 days, from the date of allogeneic HSCT; median (min, max) follow-up time was 26.7 (3.0, 28.5)|Phase 2 participants who received an allogeneic HSCT.|||percentage of participants|||Number
2579934|NCT02412306|Secondary|Phase 2: Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission|Participants who were eligible for allogeneic HSCT were those who achieved remission (complete response or complete response with partial recovery of peripheral blood counts) after 2 cycles of blinatumomab treatment, and no further anti-leukemic medication was given before HSCT.|Median (min, max) follow-up time was 26.7 (3.0, 28.5) months.|Phase 2 participants who received any infusion of blinatumomab.|||percentage of participants|||Number
2579946|NCT02412111|Secondary|Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline Through Week 8|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Through Week 8|"Full Analysis Set was defined as all randomized participants who have received at least 1 dose of blinded study drug during the active comparator treatment period. Here Overall number of participants analyzed signifies those participants who were evaluable for this outcome."|||units on a scale||Standard Error|Least Squares Mean
2579935|NCT02412306|Secondary|Phase 2: Best Overall Response Within 2 Cycles of Treatment|"Best response was defined as one of the following:~CR: ≤ 5% blasts in the bone marrow (BM); No evidence of disease; Full recovery of peripheral blood counts: Platelets > 100,000/µl, and absolute neutrophil count (ANC) > 1,000/µl~CRh*: ≤ 5% blasts in BM; No evidence of disease; Partial recovery of peripheral blood counts: Platelets > 50,000/µl, and ANC > 500/µl~CRi: CR with incomplete count recovery without CRh*~Blast free hypoplastic or aplastic BM: ≤ 5 % blasts in BM; No evidence of disease; Insufficient recovery of peripheral blood counts: platelets ≤ 50,000/µl and/or ANC ≤ 500/µl~Partial Remission: BM blasts > 5 to < 25% with at least a 50% reduction from baseline~Hematological Relapse: > 5% blasts in BM or blasts in peripheral blood after documented CR/CRh* during the study~PD: An increase from baseline of ≥ 25% of BM blasts or an absolute increase of ≥ 5,000 cells/µL in the number of circulating leukemia cells."|Within the first 2 cycles of treatment, 12 weeks|Phase 2 participants who received any infusion of blinatumomab.|||Participants|||Count of Participants
2579936|NCT02412306|Secondary|Phase 1b and Phase 2: Overall Survival|"Overall survival (OS) was calculated from the start date of blinatumomab infusion in the first treatment cycle. All deaths were counted as events on the date of death.~Participants still alive were censored on the last documented visit date or the date of the last phone contact when the participant was last known to have been alive. For participants who withdrew their informed consent, only information until the date of withdrawal was used in the analysis."|Median (min, max) follow-up time was 6.3 (2.4, 13.6) months for Phase 1b and 26.7 (3.0, 28.5) months for Phase 2.|Phase 1b and Phase 2 participants who received any infusion of blinatumomab.|||months||95% Confidence Interval|Median
2579937|NCT02412306|Secondary|Phase 1b and Phase 2: Relapse-free Survival|Relapse-free survival (RFS) was defined for participants who achieved a response (CR/CRh*) during the first 2 cycles of treatment. RFS was calculated from the date of bone marrow aspiration when response was detected for the first time to the date of bone marrow aspiration at which hematological relapse was first detected or the date of diagnosis on which the hematological or extra medullary relapse was documented or the date of death due to any cause, whichever was earlier. Participants who did not experience hematological relapse and did not die were censored on the date of the last available bone marrow aspiration prior to the data cutoff date for the analysis.|Median (min, max) follow-up time was 6.3 (2.4, 13.6) months for Phase 1b and 26.7 (3.0, 28.5) months for Phase 2.|Phase 1b and Phase 2 participants who received any infusion of blinatumomab and achieved CR/CRh* during the first 2 cycles of treatment.|||months||95% Confidence Interval|Median
2579938|NCT02412306|Secondary|Phase 1b and Phase 2: Duration of Response|"Duration of response was calculated from the date of bone marrow aspiration when response (CR/CRh*) was detected for the first time during the first 2 cycles of treatment until the earlier of the following events:~the date of bone marrow aspiration at which hematological relapse or progressive disease (PD) was first detected,~the date of diagnosis on which the hematological or extra medullary relapse was documented,~the date of death if patient died due to PD~the date of end of induction phase if primary reason for treatment termination was hematological or extramedullary relapse.~For a responder who did not report an event and was alive during the study, the end date of duration (censoring) was based on the date of the last available bone marrow aspiration prior to the data cutoff date for the analysis. Participants with response who did not report an event and who died due to reasons other than PD, were censored on the date of death, with death treated as a competing risk."|Median (minimum [min], maximum [max]) follow-up time was 6.3 (2.4, 13.6) months for Phase 1b and 26.7 (3.0, 28.5) months for Phase 2.|Phase 1b and Phase 2 participants who received any infusion of blinatumomab and achieved CR/CRh* during the first 2 cycles of treatment.|||months||95% Confidence Interval|Median
2579939|NCT02412306|Secondary|Phase 1b Pediatric: Percentage of Participants With M1 Remission Within 2 Cycles of Treatment|M1 remission for pediatric participants was defined as ≤ 5% blasts (M1 bone marrow) in the bone marrow and no evidence of disease.|The first 2 cycles of treatment, 12 weeks|Phase 1b pediatric participants who received any infusion of blinatumomab.|||percentage of participants||95% Confidence Interval|Number
2579940|NCT02412306|Secondary|Phase 1b Adults: Percentage of Participants With a Best Response of Complete Remission or Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment|"Hematological assessments were performed from bone marrow biopsy samples. All hematological assessments of bone marrow were reviewed in a central reference laboratory.~Hematological remissions were defined by the following criteria:~Complete Remission (CR) is defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts: platelets > 100,000/µl and absolute neutrophil count (ANC) > 1,000/µl.~Complete Remission With Partial Hematological Recovery (CRh*) is defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts: platelets > 50,000/µl and ANC > 500/µl"|Within the first 2 cycles of treatment, 12 weeks|Phase 1b adult participants who received any infusion of blinatumomab.|||percentage of participants||95% Confidence Interval|Number
2579941|NCT02412306|Primary|Phase 2: Percentage of Participants With a Best Response of Complete Remission or Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment|"Hematological assessments were performed from bone marrow biopsy samples. All hematological assessments of bone marrow were reviewed in a central reference laboratory.~Hematological remissions were defined by the following criteria:~Complete Remission (CR) is defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts: platelets > 100,000/µl and absolute neutrophil count (ANC) > 1,000/µl.~Complete Remission With Partial Hematological Recovery (CRh*) is defined as ≤ 5% blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts: platelets > 50,000/µl and ANC > 500/µl."|Within the first 2 cycles of treatment, 12 weeks|Phase 2 participants who received any infusion of blinatumomab.|||percentage of participants||95% Confidence Interval|Number
2579942|NCT02412306|Primary|Phase 1b: Number of Participants With Dose-limiting Toxicities|Dose-limiting toxicities (DLTs) were defined as any Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 grade ≥ 3 adverse event related to blinatumomab, excluding specific CTCAE grade ≥ 3 adverse events considered consistent with the current known safety profile of blinatumomab, CTCAE grade ≥ 3 fever or infection, and laboratory parameters of CTCAE grade ≥ 3 not considered clinically relevant and/or responding to routine medical management.|Days 1 to 14|Phase 1b participants in who received any infusion of blinatumomab.|||Participants|||Count of Participants
2610758|NCT02051816|Secondary|Procedure-related Mortality|Death within 1 hour of beginning the procedure|1 hour||||Participants|||Count of Participants
2579947|NCT02412111|Secondary|Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 8|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Through Week 8|"Full Analysis Set was defined as all randomized participants who have received at least 1 dose of blinded study drug during the active comparator treatment period. Here Overall number of participants analyzed signifies those participants who were evaluable for this outcome."|||Percent change||Standard Error|Least Squares Mean
2579948|NCT02412111|Primary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 8|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Through Week 8|"Full Analysis Set was defined as all randomized participants who have received at least 1 dose of blinded study drug during the active comparator treatment period. Here Overall number of participants analyzed signifies those participants who were evaluable for this outcome."|||Percent predicted of FEV1||Standard Error|Least Squares Mean
2579949|NCT02412098|Secondary|Number of Participants Experiencing Clinical Laboratory Abnormalities|Treatment-emergent laboratory abnormalities reported as an adverse event (AE) or serious adverse event (SAE) are presented. Laboratory abnormalities that required medical or surgical intervention or led to study drug interruption, modification, or discontinuation were recorded as an AE or SAE, as applicable, and are reported here. Laboratory abnormalities without clinical significance were not recorded as AEs or SAEs and therefore, are not being reported.|First dose date up to 31 days|Participants in the Safety Analysis Set were analyzed.|||Participants|||Count of Participants
2579950|NCT02412098|Secondary|Number of Participants Experiencing Treatment-Emergent Adverse Events|"Treatment-emergent adverse events (AEs) are defined as one or both of the following:~Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug.~Any AEs leading to premature discontinuation of study drug."|First dose date up to 31 days|Safety Analysis Set included all enrolled participants who received at least one dose of study drug.|||Participants|||Count of Participants
2579951|NCT02412098|Primary|PK Parameter: Cmax of GS-623134 (Metabolite of Eleclazine)|Cmax was defined as the maximum observed concentration of drug in plasma.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours on Day 1 and approximately the same time in the morning as predose of Day 1 on Days 15, 29, 43, and 57|Participants in the PK Analysis Set with available data were analyzed. Healthy control participants may participate in more than one cohorts.|||ng/mL||95% Confidence Interval|Geometric Mean
2579952|NCT02412098|Primary|PK Parameter: Cmax of Eleclazine|Cmax was defined as the maximum observed concentration of drug in plasma.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours on Day 1 and approximately the same time in the morning as predose of Day 1 on Days 15, 29, 43, and 57|Participants in the PK Analysis Set were analyzed. Healthy control participants may participate in more than one cohorts.|||ng/mL||95% Confidence Interval|Geometric Mean
2579953|NCT02412098|Primary|PK Parameter: AUCinf of GS-623134 (Metabolite of Eleclazine)|AUCinf was defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).|Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours on Day 1 and approximately the same time in the morning as predose of Day 1 on Days 15, 29, 43, and 57|Participants in the PK Analysis Set with available data were analyzed. Healthy control participants may participate in more than one cohorts.|||h*ng/mL||95% Confidence Interval|Geometric Mean
2579954|NCT02412098|Primary|PK (Pharmacokinetic) Parameter: AUCinf of Eleclazine|AUCinf was defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).|Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72, 96, 120 hours on Day 1 and approximately the same time in the morning as predose of Day 1 on Days 15, 29, 43, and 57|PK Analysis Set included all enrolled participants who received at least one dose of eleclazine and had at least one evaluable PK concentration value reported by the PK laboratory for the corresponding analyte. Healthy control participants may participate in more than one cohorts.|||h*ng/mL||95% Confidence Interval|Geometric Mean
2579955|NCT02411929|Secondary|Number of Participants Discontinuing Study Drug Due to Adverse Events (Periods 1 and 2)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to approximately 16 days|The Safety Population included all participants who received at least one dose of study drug.|||Participants|||Number
2579956|NCT02411929|Secondary|Number of Participants Who Experienced an Adverse Event (Periods 1 and 2)|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to approximately 33 days|The Safety Population included all participants who received at least one dose of study drug.|||Participants|||Number
2579957|NCT02411929|Secondary|Pharmacokinetic Parameter: Fraction Absorbed (Fa, Radioactivity in Urine) (Periods 1 and 2) (Dose Normalized)|Fraction absorbed is the fraction of the total ertugliflozin dose absorbed, regardless of the fate of that dose after absorption (i.e., metabolism, degradation, etc). Fraction Absorbed was estimated as the ratio of total radioactivity (dose normalized) excreted into the urine (from time zero to the time of last measurable concentration) following oral and IV administration of 14^C-ertugliflozin. Fraction of 14^C dose recovered in urine = 14^C total in urine in dpm/14^C total in dose in dpm|Part 1: pre- IV dose, 0-11 and 11-23 hrs. post IV dose, and 23 - 47, 47 - 71 and 71 - 95 hrs. until Day 5; Part 2: predose, 0-12 and 12-24 hrs. post dose, and then 24-hour intervals until Day 5|The estimated Fa Population included only the 6 participants with complete urine data for both treatments.|||Fraction of 14^C dose recovered in urine||Geometric Coefficient of Variation|Geometric Mean
2579984|NCT02411578|Secondary|CGM Minimum Glucose, Event Level|Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event|120 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||mg/dL|Hypoglycemic Events|Inter-Quartile Range|Median
2579958|NCT02411929|Secondary|Pharmacokinetic Parameter: Steady-State Volume of Distribution (Vss) Following IV Infusion - IV, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Steady-State Volume of Distribution is the theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it is in blood plasma at steady state. Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin intravenous drug profile only so no participants were analyzed in the Ertugliflozin oral arm.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2579959|NCT02411929|Secondary|Pharmacokinetic Parameter: Apparent Volume of Distribution (Vz/F) Following Oral Administration - Oral, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the fraction absorbed. Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin oral drug profile only so no participants were analyzed in the 14^C-Ertugliflozin 100 ug intravneous arm.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2579960|NCT02411929|Secondary|Pharmacokinetic Parameter: Systemic IV Total Plasma Clearance (CL) - IV, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Systemic clearance is a calculation of the rate at which a drug is removed from plasma via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes). Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin intravenous drug profile only so no participants were analyzed in the Ertugliflozin oral arm.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||mL/min.||Geometric Coefficient of Variation|Geometric Mean
2579961|NCT02411929|Secondary|Pharmacokinetic Parameter: Apparent Oral Total Plasma Clearance (CL/F) - Oral, Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Apparent clearance is a calculation of the rate at which a drug is removed from plasma after oral administration via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes). Geometric coefficient of variation is given as the percent coefficient of variation. This outcome measure is for the Ertugliflozin oral drug profile only so no participants were analyzed in the 14^C-Ertugliflozin 100 ug IV arm.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||mL/min.||Geometric Coefficient of Variation|Geometric Mean
2579962|NCT02411929|Secondary|Pharmacokinetic Parameter: Terminal Elimination Half-Life (t1/2) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||Hours||Standard Deviation|Mean
2579963|NCT02411929|Secondary|Pharmacokinetic Parameter: Time for Cmax (Tmax) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose. The confidence intervals displayed are minimums to maximums.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||Hours||Full Range|Median
2580011|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio|As part of the total virus recovery assay, results for stimulated and unstimulated HIV-1 RNA (copies/mL) are generated. At each time point, the ratio of the stimulated to unstimulated HIV-1 RNA was calculated. The fold change of this ratio from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)|Measured at pre-entry and week 6|Includes all participants with available stimulated/unstimulated HIV-1 RNA results from virus recovery assay|||fold change||Inter-Quartile Range|Median
2579964|NCT02411929|Secondary|Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1) (Dose Normalized to 1 mg)|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Geometric coefficient of variation is given as the percent coefficient of variation.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2579965|NCT02411929|Secondary|Pharmacokinetic Parameter: (AUC Inf) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ertugliflozin 100 ug IV (Period 1)|AUC0-inf is a measure of the mean concentration levels of drug in the plasma after the dose. Geometric coefficient of variation is given as the percent coefficient of variation.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2579966|NCT02411929|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUC Last) Following Administration of Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV (Period 1) (Dose Not Normalized to 1 mg)|AUC0-last is a measure of the total amount of drug in the plasma from time zero to time of the last measurable concentration. Geometric coefficient of variation is given as the percent coefficient of variation.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The PK Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2579967|NCT02411929|Primary|Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUC Last) (Dose Normalized to 1 mg) and Absolute Oral Bioavailability (F) (Period 1)|AUC0-inf is a measure of the mean concentration levels of drug in the plasma after the drug dose. An absolute bioavailability provides information on the amount of a drug reaching the systemic circulation and can be determined by comparing the plasma concentration-time-curves (area under the curve) of a compound after oral application of that compound to that after intravenous application of the same compound.|Oral: 0, 15 and 30 min., and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs. after oral dose; IV: -5 min. (predose), 0 (end of infusion), and at 10, 20, 30, and 45 min. and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 11, 23, 47, 71, and 95 hrs. after end of infusion|The pharmacokinetic (PK) Parameter Analysis Population for ertugliflozin is defined as all participants treated who have at least 1 of the ertugliflozin PK parameters of interest. The PK Parameter Analysis Population for 14^C-ertugliflozin analysis is defined as all participants treated who have at least 1 of the 14^C parameters of interest.|||AUCinf(dn), ng•hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2579968|NCT02411747|Primary|Global Rating Scale|The subjects perform a flexible cystoscopy on two different patients and each cystoscopy are being scored by a specialist in Urology (the same in the entire study) using a validated scoring system for flexible cystoscopy, the Global Rating Scale. A previously validated assessment tool, Global Rating Scale (GRS) was used to assess the cystoscopy procedures. GRS is composed of five different parameters: respect for tissue, time and motion, handling of endoscope, flow of procedure, forward planning, and knowledge of procedure. Each parameter is assessed on a five point Likert scale with a minimum of one to maximum of five, giving the total GRS score a range of five to 25. At our institution we have defined a GRS score of three in each parameter (minimum total GRS of 15) as a minimum passing standard.|Two to four weeks after day of simulation training|Two cystoscopies performed on patients by each participant|||units on a scale|Number cystoscopies|Standard Deviation|Mean
2579969|NCT02411643|Secondary|Change of Appearance of Skin Biopsy|Skin biopsy will be taken at baseline and 3 months, skin will be examined for expression levels of different proteins|day 0 and 3 months|Study was terminated before results were obtained.||||||
2579970|NCT02411643|Secondary|Modified Localized Scleroderma Skin Score|The firmness or tightness of the skin will be measured throughout the body at day 0 and 3 months|day 0 and 3 months|Study was terminated before results were obtained.||||||
2579971|NCT02411643|Secondary|Quality of Life|Quality of life questions will be asked at day 0 and 3 months|day 0 and 3 months|Study was terminated prior to obtaining results.||||||
2579972|NCT02411643|Primary|Change of Gene Expression From Skin Biopsy|Skin biopsy will be taken at day 0 and 3 months, RNA will be looked at for different gene expression levels|day 0 and 3 months|Study was terminated prior to obtaining results.||||||
2579985|NCT02411578|Secondary|CGM Time Below 70 mg/dL, Event Level|Percentage of time <70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event|60 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||percentage of time|Hypoglycemic Events|Inter-Quartile Range|Median
2580012|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA|As part of the total virus recovery assay, results for unstimulated HIV-1 RNA (copies/mL) are generated. The change from the pre-treatment time point to week 6 was assessed as a fold change (week 6 / pre-entry)|Measured at pre-entry, week 6|Includes all participants with available unstimulated HIV-1 RNA results from virus recovery assay at pre-entry and week 6 time points|||fold change||Inter-Quartile Range|Median
2579973|NCT02411578|Post-Hoc|Clinical Grading - Initial Treatment Correct|2 graders, blinded to treatment arm, independently graded each hypoglycemic event as a clinical failure or success based on all available BG concentrations within 1 hour of initial treatment. All BG values, along with corresponding time elapsed since treatment, were reviewed to determine whether the response would be considered a treatment success, in a clinical setting. There were no specific cut points; rather than basing the success criteria on whether the BG was above specific cutpoints by specific times, the grader decided whether the event would be considered a success in a clinical setting (i.e. if the BG increased after treatment and reached and maintained a satisfactory level after the treatment). The graders to achieve a consensus grading adjudicated discordant gradings (6% of events). The number of events graded as a treatment success were reported out of the total number of hypoglycemic events, for each treatment arm.|60 minutes|"This analysis included all hypoglycemic events in which the initial treatment and dose were correct, irrespective of the timing of the BG measurements.~8 hypoglycemic events were deemed Indeterminate by the graders during the glucagon period and 4 during the glucose tabs period."|||Hypoglycemic Events|Hypoglycemic Events||Count of Units
2579974|NCT02411578|Post-Hoc|Clinical Grading - Initial and 15-min Treatment Correct|2 graders, blinded to treatment arm, independently graded each hypoglycemic event as a clinical failure or success based on all available BG concentrations within 1 hour of initial treatment. All BG values, along with corresponding time elapsed since treatment, were reviewed to determine whether the response would be considered a treatment success, in a clinical setting. There were no specific cut points; rather than basing the success criteria on whether the BG was above specific cutpoints by specific times, the grader decided whether the event would be considered a success in a clinical setting (i.e. if the BG increased after treatment and reached and maintained a satisfactory level after the treatment). The graders to achieve a consensus grading adjudicated discordant gradings (6% of events). The number of events graded as a treatment success were reported out of the total number of hypoglycemic events, for each treatment arm.|60 minutes|"Analysis was limited to hypoglycemic events where Initial and 15-min Treatment were correct.~4 hypoglycemic events were deemed Indeterminate by the graders during the glucagon period."|||Hypoglycemic Events|Hypoglycemic Events||Count of Units
2579975|NCT02411578|Post-Hoc|Clinical Grading - Limited to Events in Primary Analysis|2 graders, blinded to treatment arm, independently graded each hypoglycemic event as a clinical failure or success based on all available BG concentrations within 1 hour of initial treatment. All BG values, along with corresponding time elapsed since treatment, were reviewed to determine whether the response would be considered a treatment success, in a clinical setting. There were no specific cut points; rather than basing the success criteria on whether the BG was above specific cutpoints by specific times, the grader decided whether the event would be considered a success in a clinical setting (i.e. if the BG increased after treatment and reached and maintained a satisfactory level after the treatment). The graders to achieve a consensus grading adjudicated discordant gradings (6% of events). The number of events graded as a treatment success were reported out of the total number of hypoglycemic events, for each treatment arm.|60 minutes|Analysis was limited to hypoglycemic events included in the primary analysis. 3 hypoglycemic events were deemed Indeterminate by the graders during the glucagon period.|||Hypoglycemic Events|Hypoglycemic Events||Count of Units
2579976|NCT02411578|Secondary|CGM Coefficient of Variation|Coefficient of Variation from CGM data computed over entire 3 weeks of treatment period|3 weeks|Limited to participants who had at least 72 hours of CGM data during each period|||percentage coefficient of variation||Inter-Quartile Range|Median
2579977|NCT02411578|Secondary|CGM Time Below 70|Percentage of time <70 mg/dL from CGM data computed over entire 3 weeks of treatment period|3 weeks|Limited to participants who had at least 72 hours of CGM data during each period|||percentage of time||Inter-Quartile Range|Median
2579978|NCT02411578|Secondary|CGM Time in Range|Percentage of time 70-180 mg/dL from CGM data computed over entire 3 weeks of treatment period|3 weeks|Limited to participants who had at least 72 hours of CGM data during each period|||percentage of time||Inter-Quartile Range|Median
2579979|NCT02411578|Secondary|CGM Mean Glucose|Median (IQR) reported for mean glucose from CGM data computed over entire 3 weeks of treatment period|3 weeks|Limited to participants who had at least 72 hours of CGM data during each period|||mg/dL||Inter-Quartile Range|Median
2579980|NCT02411578|Secondary|CGM Time Below 70 mg/dL|Percentage of time <70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event|120 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||percentage of time|Hypoglycemic Events|Inter-Quartile Range|Median
2579981|NCT02411578|Secondary|CGM Time in Range, Event Level|Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event|120 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||percentage of time|Hypoglycemic Events|Inter-Quartile Range|Median
2579982|NCT02411578|Secondary|CGM Mean Glucose, Event Level|Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event|120 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||mg/dL|Hypoglycemic Events|Inter-Quartile Range|Median
2579983|NCT02411578|Secondary|CGM Maximum Glucose, Event Level|Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event|120 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||mg/dL|Hypoglycemic Events|Inter-Quartile Range|Median
2579986|NCT02411578|Secondary|CGM Time in Range, Event Level|Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event|60 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||percentage of time|Hypoglycemic Events|Inter-Quartile Range|Median
2579987|NCT02411578|Secondary|CGM Mean Glucose, Event Level|Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event|60 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||mg/dL|Hypoglycemic Events|Inter-Quartile Range|Median
2579988|NCT02411578|Secondary|CGM Maximum Glucose, Event Level|Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event|60 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||mg/dL|Hypoglycemic Events|Inter-Quartile Range|Median
2579989|NCT02411578|Secondary|Continuous Glucose Monitor (CGM) Minimum Glucose, Event Level|Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event|60 Minutes|A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be <80 mg/dL|||mg/dL|Hypoglycemic Events|Inter-Quartile Range|Median
2579990|NCT02411578|Primary|Number of Hypoglycemic Events ≥50 mg/dl 15 Minutes AND ≥ 70 mg/dl 30 Minutes After Initial Treatment||30 minutes|Limited to events with starting BG of 50-69 mg/dL|||Hypoglycemic Events|Hypoglycemic Events||Count of Units
2579991|NCT02411565|Other Pre-specified|Incidence of Changes in Tissue Proliferative Assays and Gene Expression|Changes in tissue proliferative assays and gene expression per treatment arm.|Up to 2 months|||||||
2579992|NCT02411565|Secondary|Occurence of CA-125 Response|Biomarker-based response involves assessing the participant's longitudinal CA-125 values. The definition of CA-125 response is based on the Gynecologic Cancer Intergroup (GCIG 2005) criteria. CA-125 response was to be determined and compared between FWGE and placebo treated groups of 10 participants each.|Up to 2 months|Drug manufacturing issues prevented investigators from completing the planned analysis.||||||
2579993|NCT02411565|Secondary|Level of 2,6-dimethoxy-p-benzoquinone (2,6-DMBQ)|Investigators planned to perform Level comparison of 2,6-dimethoxy-p-benzoquinone (2,6-DMBQ) in the serum of women receiving FWGE versus placebo for 20 participants.|Up to 2 months|Drug manufacturing issues prevented investigators from completing the planned analysis.||||||
2579994|NCT02411565|Secondary|Quality of Life Scores Per Treatment Arm|FACT-O Quality of Life Score comparison per category and arm: Physical Well-Being; Social/Family Well-Being; Emotional Well-Being; Functional Well-Being; Additional Concerns. Score range for each question: 0 (Not at all) through 4 (Very much). High or Low Score could mean better or worse, depending on the wording of each group of questions. Investigators planned to analyze scores per treatment arm, in women who received Fermented Wheat Germ Extract (FWGE) (n=10) and those who received placebo (n=10). Drug manufacturing issues prevented investigators from completing the planned analysis.|Up to 2 months|Drug manufacturing issues prevented investigators from completing the planned analysis.||||||
2579995|NCT02411565|Primary|Occurrence of Adverse Events Probably Related to Study Treatment|"Adverse events reported per treatment arm. An adverse event is the development of an untoward medical occurrence, undesirable medical condition, or recurrence or deterioration of a pre-existing medical condition subsequent to exposure to FWGE. This study will utilize the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) for toxicity and adverse event reporting.~Number of Adverse Events Probably Related to Study Treatment. All Adverse Events are listed, with causality noted in the Adverse Event section."|Up to 2 months|All participants.|||Adverse Events|||Number
2579996|NCT02411539|Secondary|VRC01 Antibody Level Relative to Infusion Timing|Summarize the pharmacokinetics (PK) of two infusions of VRC01 during study follow up - aligning the timing of PK samples/results to the respective VRC01 infusions for each Arm|Measured immediately after first infusion (and 1, 2, and 3 weeks after), and immediately after second infusion (and 1, 2, 3, 6 and 9 weeks after)|Analysis of all participants with available results.|||ug/mL||Inter-Quartile Range|Median
2579997|NCT02411539|Secondary|Plasma Levels of High-sensitivity C-reactive Protein (hsCRP)|Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.||||||
2579998|NCT02411539|Secondary|Plasma Levels of Tumor Necrosis Factor Alpha (TNFα)|Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.||||||
2580071|NCT02410824|Secondary|Overall Satisfaction|Overall satisfaction of stenfilcon A and etafilcon A lenses. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied.|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2611470|NCT02043379|Secondary|Serum Creatinine|Pre-operative and 48 hour post-operative maximum creatinine recorded.|48 hours||||mg/dL||Standard Deviation|Mean
2579999|NCT02411539|Secondary|Plasma Levels of Human Soluble Tumor Necrosis Factor Alpha-receptor (sTNFαR)|Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.||||||
2580000|NCT02411539|Secondary|Plasma Levels of Interleukin-6 (IL-6)|Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.||||||
2580001|NCT02411539|Secondary|Plasma Levels of sCD14|Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.||||||
2580002|NCT02411539|Secondary|Plasma Levels of sCD163|Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes.|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.||||||
2580003|NCT02411539|Secondary|Levels of NK Cell Activation|"% NK cells expressing CD69 or CD95~Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes."|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.||||||
2580004|NCT02411539|Secondary|Levels of T-cell Activation|"% CD4+ and CD8+ T-cells co-expressing human leukocyte antigen (HLA)-DR and CD38~Not conducted as part of primary analysis and there are no future plans to assess this outcome. Samples were collected for this outcome in order to assess associations with virologic effects observed. Due to the lack of virologic effect observed, the study team has decided that this outcome is no longer of priority/interest and will be abandoned in favor of saving these samples for future research purposes."|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis not performed. See outcome measure description for reasoning.||||||
2580005|NCT02411539|Secondary|Detectability of Antibody to VRC01 as Measured in Serum|Assess the detectability of antibody to VRC01 in samples collected during study follow-up. Intended to be result from specimen at week 30 time point. Due to specimen availability, four participants in Arm A had results from specimens from the week 18 time point. Counts provided are number of participants with detectable anti-VRC01 antibody result.|Measured at week 30|All participants with results for anti-VRC01 antibody. Two participants did not have results (one from each arm) due to being lost to follow up.|||Participants|||Count of Participants
2580006|NCT02411539|Secondary|VRC01 Antibody Level|"Summarize the pharmacokinetics (PK) of two infusions of VRC01 during study follow up~Specific specimens and time points were targeted for testing based on Arm. Samples for Arm A were not tested for the Week 6 and Week 9 post-infusion time points. Samples for Arm B were not tested for the Week 0 and Week 3 post-infusion time points."|Measured at entry and weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18 and 30|Analysis of all participants with available results.|||ug/mL||Inter-Quartile Range|Median
2580007|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Percentage of Total CD4 Yield|As part of the total virus recovery assay, results for %tCD4 yield are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)|Measured at pre-entry, week 6|Includes all participants with available %tCD4 yield results from virus recovery assay at pre-entry and week 6 time points|||fold change||Inter-Quartile Range|Median
2580008|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio|As part of the total virus recovery assay, results for stimulated and unstimulated cell fluor (light units) are generated. At each time point, the ratio of the stimulated to unstimulated cell fluor was calculated. The fold change of this ratio from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)|Measured at pre-entry, week 6|Includes all participants with available stimulated/unstimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points|||fold change||Inter-Quartile Range|Median
2580009|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Unstimulated Cell Fluor|As part of the total virus recovery assay, results for unstimulated cell fluor (light units) are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)|Measured at pre-entry, week 6|Includes all participants with available unstimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points|||fold change||Inter-Quartile Range|Median
2580010|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Stimulated Cell Fluor|As part of the total virus recovery assay, results for stimulated cell fluor (light units) are generated. The fold change from pre-entry to the week 6 time point was calculated for each arm (week 6 / pre-entry)|Measured at pre-entry, week 6|Includes all participants with available stimulated cell fluor results from virus recovery assay at pre-entry and week 6 time points|||fold change||Inter-Quartile Range|Median
2580072|NCT02410824|Secondary|Dryness|Subjective ratings of lens performance for dryness assessed during the day and at the end of the day. Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time.|1 Week||||units on a scale||Standard Deviation|Mean
2580013|NCT02411539|Secondary|Change in Total/Inducible Virus Recovery - Stimulated HIV-1 RNA|As part of the total virus recovery assay, results for stimulated HIV-1 RNA (copies/mL) are generated. The change from the pre-treatment time point to week 6 was assessed as a fold change (week 6 / pre-entry)|Measured at pre-entry, week 6|Includes all participants with available stimulated HIV-1 RNA results from virus recovery assay at pre-entry and week 6 time points|||fold change||Inter-Quartile Range|Median
2580014|NCT02411539|Secondary|Total/Inducible Virus Recovery - Percentage of Total CD4 Yield|As part of the total virus recovery assay, results for %tCD4 yield are generated.|Measured at pre-entry, week 6 and week 12|Includes all participants with available %tCD4 yield results from virus recovery assay|||percentage of Total CD4 Yield||Inter-Quartile Range|Median
2580015|NCT02411539|Secondary|Total/Inducible Virus Recovery - Stimulated to Unstimulated Cell Fluor Ratio|As part of the total virus recovery assay, results for stimulated and unstimulated cell fluor (light units) are generated. At each time point, the ratio of the stimulated to unstimulated cell fluor was calculated.|Measured at pre-entry, week 6 and week 12|Includes all participants with available stimulated/unstimulated cell fluor results from virus recovery assay|||ratio||Inter-Quartile Range|Median
2580016|NCT02411539|Secondary|Total/Inducible Virus Recovery - Unstimulated Cell Fluor|As part of the total virus recovery assay, results for unstimulated cell fluor (light units) are generated.|Measured at pre-entry, week 6 and week 12|Includes all participants with available unstimulated cell fluor results from virus recovery assay|||million light units||Inter-Quartile Range|Median
2580017|NCT02411539|Secondary|Total/Inducible Virus Recovery - Stimulated Cell Fluor|As part of the total virus recovery assay, results for stimulated cell fluor (light units) are generated.|Measured at pre-entry, week 6 and week 12|Includes all participants with available stimulated cell fluor results from virus recovery assay|||million light units||Inter-Quartile Range|Median
2580018|NCT02411539|Secondary|Total/Inducible Virus Recovery - Stimulated to Unstimulated HIV-1 RNA Ratio|As part of the total virus recovery assay, results for stimulated and unstimulated HIV-1 RNA (copies/mL) are generated. At each time point, the ratio of the stimulated to unstimulated HIV-1 RNA was calculated.|Measured at pre-entry, week 6 and week 12|Includes all participants with available stimulated/unstimulated HIV-1 RNA results from virus recovery assay|||ratio||Inter-Quartile Range|Median
2580019|NCT02411539|Secondary|Total/Inducible Virus Recovery - Unstimulated HIV-1 RNA|As part of the total virus recovery assay, results for unstimulated HIV-1 RNA (copies/mL) are generated|Measured at pre-entry, week 6 and week 12|Includes all participants with available unstimulated HIV-1 RNA results from virus recovery assay|||log10 copies/mL||Inter-Quartile Range|Median
2580020|NCT02411539|Secondary|Total/Inducible Virus Recovery - Stimulated HIV-1 RNA|As part of the total virus recovery assay, results for stimulated HIV-1 RNA (copies/mL) are generated|Measured at pre-entry, week 6 and week 12|Includes all participants with available stimulated HIV-1 RNA results from virus recovery assay|||log10 copies/mL||Inter-Quartile Range|Median
2580021|NCT02411539|Secondary|CD8+ T-cell Counts|Baseline measure represents the average of screening and entry results|Measured at screening, entry and weeks 6, 12, 18 and 30|Analysis of all participants with available CD8+ results|||cells/mm^3||Inter-Quartile Range|Median
2580022|NCT02411539|Secondary|CD4+ T-cell Counts|Baseline measure represents the average of screening and entry results|Measured at screening, entry and weeks 6, 12, 18 and 30|Analysis of all participants with available CD4+ results|||cells/mm^3||Inter-Quartile Range|Median
2580023|NCT02411539|Secondary|Number of Participants With Plasma HIV-1 RNA by Single Copy Assay (SCA) Below Assay Lower Limit|"The analysis of HIV-1 RNA SCA assessed the number of participants below the assay lower limit (1 copy/mL) at each measurement week. Specific specimens and time points were targeted based on Arm. Samples were not tested for Arm A at the Week 7 and Week 10 time points. Samples were not tested for Arm B at the Week 1 and Week 4 time points.~Testing of specimens at weeks 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes."|Measured at screening, entry and weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis of participants with available SCA results|||Participants|||Count of Participants
2580024|NCT02411539|Secondary|Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells|Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Baseline values are the geometric mean of screening and entry results. Testing of specimens at weeks 1, 4, 7, 10, 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes.|Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis of participants with available cell-associated HIV-1 RNA/DNA ratio|||log10 ratio||Inter-Quartile Range|Median
2580025|NCT02411539|Secondary|Cell-associated HIV-1 DNA in Total CD4+ Cells|Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Baseline values are the geometric mean of screening and entry results. Testing of specimens at weeks 1, 4, 7, 10, 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes.|Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis of participants with available cell-associated HIV-1 DNA results|||log10 copies/million CD4||Inter-Quartile Range|Median
2580026|NCT02411539|Secondary|Cell-associated HIV-1 RNA in Total CD4+ Cells|Testing priority was given to samples from screening, entry and weeks 3, 6, 9 and 12. Baseline values are the geometric mean of screening and entry results. Testing of specimens at weeks 1, 4, 7, 10, 15, 18 and 30 has not been performed. The study team has decided in favor of saving these samples for future research purposes.|Measured at screening, entry, weeks 1, 3, 4, 6, 7, 9, 10, 12, 15, 18 and 30|Analysis of participants with available cell-associated HIV-1 RNA results|||log10 copies/million CD4||Inter-Quartile Range|Median
2580027|NCT02411539|Secondary|Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells - Across Arms|Summary of within-participant change across treatment arms from the pre-VRC01 time point to the post-VRC01 time point. For Arm A, the pre-VRC01 time point used was the baseline measure (geometric average of screening and entry results) and the post-VRC01 time point was the week 6 measure. For Arm B, the pre-VRC01 time point used was the week 6 measure and the post-VRC01 time point was the week 12 measure. Change in CA-RNA/DNA ratio was calculated on the log10 scale.|Screening, entry and weeks 6 and 12|Analysis of all participants with available pre- and post-VRC01 cell-associated RNA/DNA ratio results available. Participants from Arm A must have had results at entry and week 6. Participants from Arm B must have had results from week 6 and week 12.|||log10 ratio||Inter-Quartile Range|Median
2580028|NCT02411539|Secondary|Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells - Last Value Carried Forward (LVCF)|Change from baseline (geometric average of screening and entry results) to week 6 in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells, using a last value carried forward approach if week 6 cell-associated HIV-1 RNA/DNA ratio was missing. In the event that the week 6 value was missing, the week 3 value was carried forward to be used. This comparison is the change from the average of screening and entry results to the week 6 value (if available), and if week 6 result was not available, the week 3 value was used instead of the week 6 value.|Screening, entry, week 3 and week 6 (week 3 used as LVCF if necessary)|Analysis of participants with available results for the change in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells, carrying last available result forward if missing at week 6|||log10 ratio||Inter-Quartile Range|Median
2580029|NCT02411539|Secondary|Number of Participants With Premature Treatment Discontinuation, for Reasons Related to Study Treatment|Study treatment was taken from entry through week 12 - this outcome assesses the number of participants who permanently and prematurely discontinued study treatment due to reasons related to the study treatment|Measured from study treatment initiation to study treatment discontinuation (study treatment dispensed through week 12)|All participants who received at least one infusion of study treatment|||Participants|||Count of Participants
2580030|NCT02411539|Primary|Change in Cell-associated HIV-1 RNA/DNA Ratio in Total CD4+ Cells|Change from baseline (geometric average of screening and entry results) to week 6 in log10 transformed cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells|Screening, entry and week 6|Analysis of participants with available results for the change in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells. All participants received at least one dose of the randomized treatment assigned. No participants received the incorrect treatment.|||log10 ratio||Inter-Quartile Range|Median
2580031|NCT02411539|Primary|Number of Participants Who Experienced Grade 3 or Greater, Treatment Related, Adverse Event (AE)|"Refer to detailed description in the protocol section.~Includes signs/symptoms, lab toxicities, and/or clinical events that are possibly, probably, or definitely related to study treatment (as judged by the core team, blinded to treatment arm) at any time from the initial dose of VRC01 to end of study follow-up. This analysis was primarily descriptive and no significance testing was performed."|Measured from study treatment initiation to study discontinuation (study duration is 30 weeks)|Includes all available follow-up for all participants|||Participants|||Count of Participants
2580032|NCT02411461|Primary|Intelligence Quotient|Intelligence quotient as measured by Kaufman Brief Intelligence Test, 2nd Edition. This scale yields standard scores where the mean is 100 and one standard deviation is 15. Higher scores indicate better function.|one day||||units on a scale||Standard Deviation|Mean
2580033|NCT02411448|Secondary|Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score|The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death.|Baseline, Cycle 40 (each cycle is 2 weeks)|Part B: All randomized participants who completed the EQ-5D-5L at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy.|||score on a scale||Standard Deviation|Mean
2580034|NCT02411448|Secondary|Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score|The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death.|Baseline, Cycle 28 (each cycle is 2 weeks)|Part B: All randomized participants who completed the EQ-5D-5L at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy.|||score on a scale||Standard Deviation|Mean
2580035|NCT02411448|Secondary|Part B: Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score|The EQ-5D-5L is a standardized instrument used to measure self-reported health status of the participants. It consists of 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). There are 5 response levels (no problems, slight problems, moderate problems, severe problems, and extreme problems/unable to), ranging from 1 to 5 (good to bad). Dimension responses were converted to an index score using UK weights. The index scores were anchored on full health (1.0) to dead (0) with negative values assigned to health states considered worse than death.|Baseline, Cycle 10 (each cycle is 2 weeks)|Part B: All randomized participants who completed the EQ-5D-5L at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy.|||score on a scale||Standard Deviation|Mean
2580036|NCT02411448|Secondary|Part B: Best Change From Baseline on the Lung Cancer Symptom Scale (LCSS)|The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-millimeter (mm) lines. A higher score for any item represented a higher level of symptoms/problems. The LCSS total score was defined as the mean of all 9 items. Average symptom burden index (ASBI) was calculated as the mean of the six symptom-specific questions from the LCSS. Potential scores range from 0 (for best outcome) to 100 (for worst outcome).|Baseline, End of Study (Up To 37 Months)|Part B: All randomized participants who completed the LCSS at baseline and at least once post-baseline. Per protocol, Part A did not evaluate efficacy.|||millimeter||Standard Error|Least Squares Mean
2580037|NCT02411448|Secondary|Part B: Number of Participants With Anti-Ramucirumab Antibodies|Part B: Number of Participants With Anti-Ramucirumab Antibodies.|Cycle 1 Predose through Follow-up (Up To 37 Months)|All participants who received at least one dose of study drug. Per protocol, Part A did not evaluate Anti-Ramucirumab Antibodies .|||Participants|||Count of Participants
2584409|NCT02356588|Secondary|Analysis of Total Number of Doses Used During the 24-Hour Study Period in the ITT Population||24 hours||||mean number of tablets taken||Standard Deviation|Mean
2580038|NCT02411448|Secondary|Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab|Part B: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab|Cycle 2 Day 1: Predose; Cycle 4 Day 1: Predose; Cycle 7 Day 1: Predose; Cycle 14 Day 1|Part B participants who received at least one dose of Ramucirumab+ Erlotinib who had evaluable PK data. Per protocol, Part A did not evaluate PK.|||microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2580039|NCT02411448|Secondary|Part B: Duration of Response (DoR)|DoR was defined as the date of first documented CR or PR (responder) to the date of progressive disease or the date of death due to any cause, whichever was earlier. If a responder was not known to have died or have progressive disease, then the participant was censored at the date of last evaluable tumor assessment.CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.|Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up To 37 Months)|Part B: All randomized participants grouped according to their assigned treatment at randomization that had a response (CR or PR). Per protocol, Part A did not evaluate efficacy.|||months||95% Confidence Interval|Median
2580040|NCT02411448|Secondary|Part B: Percentage of Participants With CR, PR, or Stable Disease (SD) (Disease Control Rate [DCR])|DCR was defined as the percentage of randomized participants achieving a best overall response of CR,PR, or stable disease(SD) assessed via Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1. CR was defined as the disappearance of all lesions,pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions.PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease(PD) was at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of 1 or more new lesions is also considered progression.|Randomization to Progressive Disease (Up To 37 Months)|Part B: All randomized participants grouped according to their assigned treatment at randomization. Per protocol, Part A did not evaluate efficacy.|||percentage of participants||95% Confidence Interval|Number
2580041|NCT02411448|Secondary|Part B: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])|ORR was defined as the percentage of randomized participants achieving a best overall response of partial response (PR) or complete response (CR) assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all lesions, pathological lymph node reduction in short axis to <10 mm, and normalization of tumor marker levels of non-target lesions. PR was at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.|Randomization to Progressive Disease (Up To 37 Months)|Part B: All randomized participants grouped according to their assigned treatment at randomization. Per protocol, Part A did not evaluate efficacy.|||percentage of participants||95% Confidence Interval|Number
2580042|NCT02411448|Secondary|Part B: Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause. For each participant who was not known to have died as of the data-inclusion cutoff date for a particular analysis,OS was censored for that analysis at the date of last contact prior to the data-inclusion cutoff date (contacts considered in the determination of last contact date include adverse event (AE) date, lesion assessment date, visit date, and last known alive date).|Randomization to Date of Death from Any Cause (Up To 37 Months)|Part B: All randomized participants grouped according to their assigned treatment at randomization. Censored participants were: Part B: Ramucirumab+ Erlotinib= 187 and Part B: Placebo+ Erlotinib= 183. Per protocol, Part A did not evaluate efficacy.|||months||95% Confidence Interval|Median
2580043|NCT02411448|Primary|Number of Participants With Treatment-Emergent Adverse Events|A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|Cycle 1 Day 1 through End of Study (Up To 3 Years)|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2580044|NCT02411448|Primary|Part B: Progression Free Survival (PFS)|PFS is defined as the time from the date of randomization to the date of radiographically documented progressive disease (PD) based on investigator assessment, or the date of death due to any cause, whichever is first assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression.|Randomization to Measured Progressive Disease or Death from Any Cause (Up To 37 Months)|Part B: All randomized participants grouped according to their assigned treatment at randomization. Censored participants were: Part B: Ramucirumab+ Erlotinib= 102 and Part B: Placebo+ Erlotinib= 67. Per protocol, Part A did not evaluate efficacy.|||Months||95% Confidence Interval|Median
2580045|NCT02411396|Secondary|Patient Reported Perception of Risk From Visit|One question on the survey asked patients to rate the overall level of medical safety they felt during their visit to the ED or IC. Choices for responses: Excellent, Very Good, Good, Fair or Poor. Excellent and Very Good were determined as having greater feelings of overall safety while patients who chose Good, Fair or Poor were determined having lesser feelings of overall safety.|within 72 hours of acute visit|Only 205 patients completed the perception of risk question at the first visit to either the ED or the IC.|||Participants|||Count of Participants
2582704|NCT02376166|Secondary|Episodes of Watery Bowel Movements|Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 2st reported outcome - Number of episodes of watery bowel movements|6 months||||episodes|||Number
2580046|NCT02411396|Secondary|Patient Reported Satisfaction With Care Received|Survey to capture patient satisfaction with the quality of care in either the ED or IC. Validated a new tool to assess satisfaction with care in the acute care setting. The new tool was developed based on existing tools that assessed several domains: adequacy of pain management, communication with providers, interpersonal aspects of care, provider competence, involvement of family/friends, and access to care. The final 15 item validated Patient Satisfaction with Pain Management in Sickle Cell Disease (SCD) (PSPS) scale was used to compare satisfaction of care comparing ED to IC acute visits. Overall mean satisfaction scores ranged from 0-7 with higher scores signifying greater satisfaction|within 72 hours of acute visit|207 participants completed the satisfaction survey after their first visit during the study time period.|||score on a scale||Standard Deviation|Mean
2580047|NCT02411396|Secondary|Pain Reassessment Within 30 Minutes of First Dose of Parenteral Pain Medication Administered|Odds of being re-assessed for pain within 30 minutes of receiving first dose of pain medication in ED vs IC. NHLBI guidelines recommend that patients are re-assessed for adequacy of pain management 30 minutes after receiving pain medication.|30 minutes after administration|Not all participants enrolled in the study visited the ED or the IC for uncomplicated vaso-occlusive crisis. The total number of subjects analyzed exceeds the total number of subjects because the same subject could visit the ED or IC one or more times.|||number of visits|number of visits||Number
2580048|NCT02411396|Secondary|Disposition From Acute Care Visit|Odds for admission to the hospital versus discharge to home (ED vs IC)|Day 1 of admission|Not all participants enrolled in the study visited the ED or the IC for uncomplicated vaso-occlusive crisis. The total number of subjects analyzed exceeds the total number of subjects because the same subject could visit the ED or IC one or more times.|||number of visits|number of visits||Number
2580049|NCT02411396|Primary|Time (Minutes) From Arrival to Center to Time First Dose of Parenteral Pain Medication Administered|Time is recorded from the time the patient arrives for pain treatment at either the ED or IC until the time the patient is dosed with pain medication administered parenterally. Guideline recommendations are that patients receive non-oral pain medication within 60 minutes of arrival.|Within 6 hours after arrival|Not all participants enrolled in the study visited the ED or the IC for uncomplicated vaso-occlusive crisis. The total number of subjects analyzed exceeds the total number of subjects because the same subject could visit the ED or IC one or more times.|||minutes|number of visits|95% Confidence Interval|Mean
2580050|NCT02411292|Primary|Number of Participants With Bleeding Events|Bleeding events requiring alteration in the course of care within 90 days of surgery|90 days|Bleeding events are reported for the 94 who were not discharged prior to the third Enoxaparin dose. Because two bleeding events occurred prior to the drawing of labs, they cannot be classified into low vs. in-range/high enoxaparin levels. Because of this, reporting on bleeding events is reported across the whole study population and not by arm.|||Participants|||Count of Participants
2580051|NCT02411292|Primary|Number of Participants With Venous Thromboembolism Events|Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery|90 days|Patients with out-of-range levels or missing levels were dropped from relevant analyses. Of the 89 participants who completed the study, 88 had peak steady-state anti-factor Xa levels to be analyzed.|||Participants|||Count of Participants
2580052|NCT02411201|Secondary|MRI Lesion Visualization at Subject Level|"Lesion visualization was assessed on up to five most representative lesions per subject based on scoring of 3 co-endpoints:~border delineation (based on a 3-point scale where 1=none; 2=moderate and 3=clear and complete)~internal morphology (based on a 3-point scale where 1=poorly visible; 2=moderately visible and 3=sufficiently visible)~contrast enhancement (based on a 3-point scale where 1=none; 2=weak and 3=clear and bright)~For each co-endpoint, a sum of scores was calculated at subject level as follows: sum of scores = score of the lesion 1 (+ score of the lesion 2 + score of the lesion 3 + score of the lesion 4 + score of the lesion 5, when applicable)"|Pre-injection and post-injection (estimated between 5 and 20 minutes after injection)|Lesion visualization was evaluated in 28 subjects who underwent contrast-enhanced MRI for central nervous system indication.|||units on a scale||Standard Deviation|Mean
2580053|NCT02411201|Secondary|Simulated Plasma Concentration of DOTAREM|Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method.|at 10 and 20 min post-injection|Among the 45 subjects who received one injection of DOTAREM, all had at least one blood sample available for pharmacokinetics.|||µmol/L||Full Range|Median
2580054|NCT02411201|Primary|Volume of Distribution of DOTAREM at Steady State|Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Volume of distribution at steady state was determined from typical and individual DOTAREM concentration-time profiles.|Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection|Among the 45 subjects who received one injection of DOTAREM, all had at least one blood sample available for pharmacokinetics.|||L/kg||Full Range|Mean
2580055|NCT02411201|Primary|Total Clearance of DOTAREM From Plasma|Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Total clearance was determined from typical and individual DOTAREM concentration-time profiles.|Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection|Among the 45 subjects who received one injection of DOTAREM, all had at least one blood sample available for pharmacokinetics.|||L/hour per kg||Full Range|Mean
2580056|NCT02411201|Primary|Terminal Elimination Half-life of DOTAREM From Plasma|Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Terminal elimination half-life was determined from typical and individual DOTAREM concentration-time profiles.|Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection|Among the 45 subjects who received one injection of DOTAREM, all had at least one blood sample available for pharmacokinetics.|||hour||Full Range|Mean
2580073|NCT02410824|Primary|Lens Fit Acceptance|Lens fit acceptance (on eye stability) for stenfilcon A and etafilcon A assessed at baseline and 1 week. Scale 0-4, 0=Can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
2580057|NCT02411201|Primary|Rate Constant of the Terminal Phase of DOTAREM|Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Rate constant of the terminal phase was determined from typical and individual DOTAREM concentration-time profiles.|Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection|Among the 45 subjects who received one injection of DOTAREM, all had at least one blood sample available for pharmacokinetics.|||hour-1||Full Range|Median
2580058|NCT02411201|Primary|Area Under the Curve of DOTAREM in Plasma|Pharmacokinetics interpretation was performed using a pharmacokinetic population modelling approach. DOTAREM concentrations in plasma were analyzed using a validated LC-MS/MS method. Area under the curve was determined from typical and individual DOTAREM concentration-time profiles.|Blood samples were collected during 3 time windows: 15 min to 60 min, 2 hours to 4 hours and 6 hours to 8 hours post-injection|Among the 45 subjects who received one injection of DOTAREM, all had at least one blood sample available for pharmacokinetics.|||hour.µmol/L||Full Range|Median
2580059|NCT02411110|Primary|Change From Baseline in Daily Average Bladder Pain to Treatment 1 Week 4 Follow-up|The participant recorded their bladder pain over the previous 24-hour period in a 7-day pain assessment tool using an 11-point Numeric Rating Scale (NRS) (0 to 10) where 0=no pain to 10= worst pain. Pain data recorded over the 7-day period were averaged. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model with baseline value as a covariate and treatment group and stratification factors (age group: < 40 years or ≥ 40 years and baseline bladder pain NRS: ≤ 6 or > 6) as factors was used for analysis.|Baseline (Days -7 to 0) to Treatment 1 Week 4|Modified Intent-to-Treat (mITT) Analysis Population included all participants who were randomized and received Treatment 1.|||score on a scale||90% Confidence Interval|Least Squares Mean
2580060|NCT02411084|Other Pre-specified|Exploratory Objectives|"The exploratory objectives for this study were:~To evaluate the change in quality of life (QoL) from baseline;~To evaluate duration of response;~To evaluate OR by standard-risk and high-risk GvHD at onset"|Time frame is up to 180 days|This analysis could not be performed because of the premature discontinuation of the study. No data are available||||||
2580061|NCT02411084|Secondary|Number of Participants With Adverse Events|The safety parameters were analysed at the end of the study period (Day 180).|The safety parameters were analysed at the end of the study period (Day 180)||||Participants|||Count of Participants
2580062|NCT02411084|Secondary|BEGEDINA Serum Concentrations Pre- and 15 Minutes Post-Infusion|The pharmacokinetic (PK) objective for this study was to characterize the serum concentrations of BEGEDINA in subjects with Grades II-IV acute GvHD who have failed to respond to steroid treatment. Data was analyzed before and 15 minutes after infusion.|Time frame is up to Day 28|The PK report presents the available data for 13 subjects on Begedina arm.|||ng/ml||Full Range|Median
2580063|NCT02411084|Secondary|Number of Participants With Overall Survival (OS) up to 180 Days|For this endpoint, no statistical confirmatory test could be performed due to insufficient sample size.|Time frame is up to 180 days||||Participants|||Count of Participants
2580064|NCT02411084|Primary|Number of Participants With Overall Response at 28 Days|"The change in grade from baseline to Study Day 28 (-1/+2 day) was used to determine the response of GvHD to treatment using the following classifications:~Complete response (CR): complete resolution of all signs of GvHD.~Partial response (PR): improvement of 1 overall grade (i.e., change from baseline in IBMTR to a less severe grading).~Stable disease (SD): No change in GvHD grading (i.e., no change from baseline in IBMTR grade).~Disease progression (PD): Deterioration in one overall grade in GvHD (i.e., worsening in IBMTR by at least 1 grade compared to baseline).~Death"|28 days for OR||||Participants|||Count of Participants
2580065|NCT02410967|Secondary|Screen for Child Anxiety Related Emotional Disorders - Child Version at Follow-up|follow-up youth self-rating of youth anxiety symptom severity over the past 14 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child self-rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.|14 days|Intent to Treat|||units on a scale||Standard Deviation|Mean
2580066|NCT02410967|Secondary|Screen for Child Anxiety Related Emotional Disorders - Child Version at Posttreatment|posttreatment youth self-rating of youth anxiety symptom severity over the past 14 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C). The SCARED-C is a child self-rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-C range from 0 to 82, with higher scores representing more severe anxiety.|14 days|Intent to Treat|||units on a scale||Standard Deviation|Mean
2580067|NCT02410967|Secondary|Screen for Child Anxiety Related Emotional Disorders - Parent Version at Follow-up|follow-up parent rating of youth anxiety symptom severity over the past 14 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P). The SCARED-P is a parent rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-P range from 0 to 82, with higher scores representing more severe anxiety.|14 days|Intent to Treat|||units on a scale||Standard Deviation|Mean
2580068|NCT02410967|Secondary|Screen for Child Anxiety Related Emotional Disorders - Parent Version at Posttreatment|posttreatment parent rating of youth anxiety symptom severity over the past 14 days. The name of the measure is the Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P). The SCARED-P is a parent rated measure of the severity of youths' anxiety symptoms. Total scores on the SCARED-P range from 0 to 82, with higher scores representing more severe anxiety.|14 days|Intent to Treat|||units on a scale||Standard Deviation|Mean
2580069|NCT02410967|Primary|Pediatric Anxiety Rating Scale at Follow-up|follow-up clinician rating of youth anxiety symptom severity over the past 7 days. The name of the measure is the Pediatric Anxiety Rating Scale (PARS). The PARS is a clinician rated measure of the severity of youths' anxiety symptoms. Total scores on the PARS range from 0 to 35, with higher scores representing more severe anxiety.|7 days|Intent to Treat|||units on a scale||Standard Deviation|Mean
2580070|NCT02410967|Primary|Pediatric Anxiety Rating Scale at Posttreatment|posttreatment clinician rating of youth anxiety symptom severity over the past 7 days. The name of the measure is the Pediatric Anxiety Rating Scale (PARS). The PARS is a clinician rated measure of the severity of youths' anxiety symptoms. Total scores on the PARS range from 0 to 35, with higher scores representing more severe anxiety.|7 days|Intent to treat|||units on a scale||Standard Deviation|Mean
2580075|NCT02410824|Primary|Conjunctival Staining|"Ocular health of conjunctival staining for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Measured in 0.50 steps, scale 0-4, 0=None, 1=Minimal diffuse punctate, 2=Coalescent punctate, 3=Confluent, 4= Deep confluent~N - Nasal, T - Temporal, S - Superior, I - Inferior"|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2580076|NCT02410824|Primary|Corneal Staining, Extent|Ocular health of corneal staining (extent) for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining 1=1-15% of area 2=16-30% of area 3=31-45% of area 4=>45% of area Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2580077|NCT02410824|Primary|Corneal Staining, Type|Ocular health of corneal staining, type for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining, 4=Severe staining Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2580078|NCT02410824|Primary|Lens Surface - Deposits|Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=no deposits, 4=severe deposits.|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
2580079|NCT02410824|Primary|Lens Surface - Wettability|Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=severely reduced, 4=excellent wettability.|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
2580080|NCT02410824|Primary|Low Visual Acuity|Low illumination high contrast (LIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.|Baseline and 1 Week||||LogMAR||Standard Deviation|Mean
2580081|NCT02410824|Primary|High Visual Acuity|High illumination high contrast (HIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.|Baseline and 1 Week||||LogMAR||Standard Deviation|Mean
2580082|NCT02410824|Primary|Vision|Subjective ratings of lens performance for vision assessed at baseline and 1 week. Scale 0-100, 0=extremely poor vision all of the time, cannot function, 100=excellent.|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
2580083|NCT02410824|Primary|Handling|Subjective ratings of lens performance for handling assessed at baseline and 1 week. Handling Scale 0-100, 0=very difficult to handle, 100=very easy to handle.|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
2580084|NCT02410824|Primary|Comfort|Subjective ratings of lens performance for comfort assessed at baseline and 1 week. Comfort Scale 0-100, 0=extremely uncomfortable/cannot tolerate, 100=extremely comfortable/cannot be felt.|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
2580085|NCT02410707|Secondary|Post-Procedure VAS Pain Score|Visual Analog Scale (0-100mm), where 0 mm is minimum pain, and 100 mm is maximum pain.|day 1||||units on a scale||Standard Deviation|Mean
2580086|NCT02410707|Secondary|Patient, Physician, and Nurse Satisfaction Surveys|Patient satisfaction with use of Nitrous Oxide in anxiolysis and pain control|day 1||||percentage of subjects||95% Confidence Interval|Number
2580087|NCT02410707|Secondary|Total Number of Physical Stimulation Events|Presence or absence of physician intervention requiring physical stimulation by the provider due to decreased oxygen saturation less than 92%|day 1||||number of subjects|||Number
2580088|NCT02410707|Secondary|Total Number of Endotracheal Intubation Events|Presence or absence of physician intervention requiring endotracheal intubation by provider due to decreased oxygen saturation less than 92%|day 1||||events of endotracheal intubation|||Number
2580089|NCT02410707|Secondary|Total Number of Positive Pressure Ventilation Events|Presence or absence of physician intervention requiring positive pressure ventilation via a bag valve max due to decreased oxygen saturation less than 92%|day 1||||events of Positive pressure ventilation|||Number
2580090|NCT02410707|Secondary|Total Number of Events Requiring Additional Oxygen|Presence or absence of physician intervention requiring additional oxygen via nasal cannula or non rebreather by the provider due to oxygen saturation less than 92%|day 1||||events of additional oxygen|||Number
2580091|NCT02410707|Secondary|Total Number of Airway Repositioning Events|Presence or absence of physician intervention requiring airway repositioning by provider due to decreased oxygen saturation less than 92%|day 1||||events of airway repositioning|||Number
2580092|NCT02410707|Primary|Total Number of Respiratory Depression Events|End tidal CO2 and SpO2 measured every 20 milliseconds seconds captured by a monitoring device. Events of respiratory depression are defined as peripheral SaO2 below 92%, ETCO2 level above 50, a rise or decrease of 10% above or below baseline, and/or the loss of the ETCO2 waveform for more than 15 seconds|day 1||||events|||Number
2580093|NCT02410629|Secondary|9-Hole Peg Test|We compared the change in 9-Hole Peg Test scores from the baseline evaluation to 3-week therapy (Intervention 1) and 12-week post-stroke to 3-week therapy (Intervention 2). The 9-Hole Peg Test is a timed test that measures the time it takes to place, and remove 9 pegs. The maximum allowed time for the test is 60 seconds. The more number of pegs placed and removed indicate a better outcome. The shorter time it takes to complete the task indicates a better outcome.|From baseline to end of therapy (3 week)||||seconds||Standard Deviation|Mean
2580094|NCT02410629|Secondary|Action Research Arm Test|We compared the change in Action Research Arm Test (ARAT) scores from the baseline evaluation to 3-week therapy (Intervention 1) and 12-week post-stroke to 3-week therapy (Intervention 2). The ARAT is a 57-point scale which measures upper extremity function, coordination, and dexterity. The higher scores indicate a better outcome.|From baseline to end of therapy (3 weeks)||||scores on a scale||Standard Deviation|Mean
2580095|NCT02410629|Secondary|Fugl-Meyer Motor Assessment of the Upper Extremity|We measure the change of the Fugl-Meyer Motor Assessment scores from the baseline evaluation to 3-week therapy (intervention 1) and 12-week post-stroke to end of 3-week therapy (Intervention 2). Fugl-Meyer is a 66-point scale measuring the movement pattern of upper extremities. For this study, we analyze total score only. The higher scores indicate a better outcome.|From baseline to end of therapy (3 weeks)||||scores on a scale||Standard Deviation|Mean
2580432|NCT02406495|Secondary|Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle).|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
2580096|NCT02410629|Primary|Box and Block Test|We compared the change of Box and Block Test scores from baseline evaluation to the end of 3-week of therapy (Intervention 1), and from 12-week post-stroke to end of 3-week therapy (Intervention 2). Participants are instructed to move as many blocks as possible, one at a time, from one compartment in a box to a second compartment over a divider for a period of 60 seconds; each block that is moved is counted, and multiple blocks moved at the same time are counted as a single block. The higher scores indicates a better outcome.|From baseline to end of therapy (3 weeks)||||blocks||Standard Deviation|Mean
2580097|NCT02410577|Primary|Binding of 89Zr-J591|This will be measured by J591 uptake in PET scan.|1 year|Data were not collected.||||||
2580098|NCT02410551|Other Pre-specified|Evaluate Safety and Efficacy of Pacritinib.|Evaluate safety and efficacy of this therapy determined by Neutrophil and platelet engraftment, Non-relapse mortality at one year post transplant, Overall survival at one year post transplant, Liver and spleen response to Pacritinib, Immune recovery, quality of life and symptom score, Primary and secondary graft failure,Complete remission, Relapse.|Start of Pacritinib to one year post transplant|Four participants was invaluable and no analysis was done.||||||
2580099|NCT02410551|Primary|Progression-free Survival (PFS)|The protocol was to enroll at least 21 evaluable participants, defined as patients who received Pacritinib for >/=60 days but less than 180 days. We enrolled four participants, however all four were not evaluable since no one was able to complete 60 days of Pacritinib.|participants who received Pacritinib for >/= 60 days but less than 180 days who undergo transplant with a matched related or at least 7/8 matched unrelated donor. The protocol was to evaluate progression free survival at one year.|Four participants were not evaluable and no analysis was done.||||||
2580100|NCT02410382|Secondary|Quality of Life as Measured by FACIT-F Version 4 Well-Being Score|To determine the effect of dexamethasone on QoL and radiation therapy treatment interruption|12 weeks|Data were collected but could not be analyzed. Study terminated by IRB and any data that were gathered, are lost. No data are available for this assessment.||||||
2580101|NCT02410382|Primary|Fatigue Measured by FACIT-F Version 4 Fatigue Score|To compare the effects of dexamethasone and placebo on radiation fatigue using validated measures|12 weeks|Data were collected but could not be analyzed. Study terminated by IRB and any data that were gathered, are lost. No data are available for this assessment.|||Participants|||Count of Participants
2580102|NCT02410343|Secondary|Pharmacokinetic Serum Concentration of TV1106 by Nominal Sampling Timepoints|Weeks 4 and 8 serum samples obtained 2 days after TV1106 administration. Weeks 12 and 24 serum samples obtained 7 days after TV1106 administration. Week 16 serum samples obtained 1 day after TV1106 administration.|Baseline (Day 1, pre-dose), Weeks 4, 8, 12, 16, 24|Safety population of participants treated with TV1106|||ng/mL||Full Range|Median
2580103|NCT02410343|Secondary|Local Tolerability Assessed by Injection Site Reactions|Participants reporting at least one injection site reaction.|Day 1 up to Week 24|Safety population|||Participants|||Count of Participants
2580104|NCT02410343|Secondary|Insulin at Baseline and Endpoint|"One measure of glucose homeostasis.~Endpoint values are the last observed post-baseline value in the Core Period."|Baseline (Day 1, pre-dose), Endpoint (up to Week 24)|Safety population of participants reporting data|||PMOL/L||Standard Deviation|Mean
2580105|NCT02410343|Secondary|Fasting Blood Glucose at Baseline and Endpoint|"One measure of glucose homeostasis.~Endpoint values are the last observed post-baseline value in the Core Period."|Baseline (Day 1, pre-dose), Endpoint (up to Week 24)|Safety population of participants reporting data|||MMOL/L||Standard Deviation|Mean
2580106|NCT02410343|Secondary|Glycated Hemoglobin (HbA1c) at Baseline and Endpoint|"One measure of glucose homeostasis.~Endpoint values are the last observed post-baseline value in the Core Period."|Baseline (Day 1, pre-dose), Endpoint (up to Week 24)|Safety population of participants reporting data|||percentage of total hemoglobin||Standard Deviation|Mean
2580107|NCT02410343|Secondary|Triiodothyronine (Total T3) at Baseline and Endpoint|"One measure of changes in replacement hormones.~Endpoint values are the last observed post-baseline value in the Core Period."|Baseline (Day 1, pre-dose), Endpoint (up to Week 24)|Safety population of participants reporting data|||NMOL/L||Standard Deviation|Mean
2580108|NCT02410343|Secondary|Free Thyroxin (Free T4) at Baseline and Endpoint|"One measure of changes in replacement hormones.~Endpoint values are the last observed post-baseline value in the Core Period."|Baseline (Day 1, pre-dose), Endpoint (up to Week 24)|Safety population of participants reporting data|||PMOL/L||Standard Deviation|Mean
2580109|NCT02410343|Secondary|Thyroid Stimulating Hormone (TSH) at Baseline and Endpoint|"One measure of changes in replacement hormones.~Endpoint values are the last observed post-baseline value in the Core Period."|Baseline (Day 1, pre-dose), Endpoint (up to Week 24)|Safety population of participants reporting data|||MIU/L||Standard Deviation|Mean
2580110|NCT02410343|Secondary|Shift From Baseline To Endpoint in Core Period in Electrocardiogram Findings|"Shifts represented as baseline - endpoint value (last observed post-baseline value).~Abnormal NCS indicates an abnormal but not clinically significant finding. Abnormal CS indicates an abnormal and clinically significant finding."|Baseline (Day 1, pre-dose), Endpoint (up to Week 24)|Safety population|||Participants|||Count of Participants
2580111|NCT02410343|Secondary|Participants With Potentially Clinically Significant Abnormal Blood and Urine Test Results|"Parameters with potentially clinically significant abnormal test results include~Serum chemistry: blood urea nitrogen, creatinine and bilirubin~Hematology: leukocytes, hemoglobin, hematocrit, platelets and neutrophils~Urinalysis: none Significance criteria are listed below with the test."|Day 1 up to 24 Weeks|Safety population|||Participants|||Count of Participants
2580112|NCT02410343|Secondary|Participants With Adverse Events During the Core Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents usual activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 up to 24 Weeks|Safety population|||Participants|||Count of Participants
2598857|NCT02181127|Primary|Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl||From t=0 to study stop after 2 weeks||||mg/dl/min||Standard Deviation|Mean
2580113|NCT02410343|Secondary|Scored Analysis of Quality of Life Assessment of GH Deficiency in Adults (QoL-AGHDA) at Baseline, Week 24 and Endpoint in Core Period|"The AGHDA instrument is comprised of 25 questions, with yes or no answers. To each of the 25 questions comprising QOL AGHDA, a score of 1 was assigned if the answer was affirmative and 0 if the answer was negative. Data reported is the total score across the 25 questions for a total range of 0-25 with higher scores representing a poorer quality of life. The outcome as defined in the protocol was the within-patient change from baseline to week 24.~Due to the early termination of the study, endpoint values are also reported. Endpoint values are the last observed post-baseline value in the Core Period, and are reported for participants who had not reached Week 24."|Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period (last post-baseline value prior to Week 24)|ITT|||units on a scale||Standard Deviation|Mean
2580114|NCT02410343|Secondary|Insulin-Like Growth Factor 1 Standard Deviation Score (IGF-I SDS) at Baseline, Week 24 and Endpoint in Core Period|"IGF-I SDS, as reported by the central laboratory, was a key secondary variable. The week 24 value is a trough value as it was taken 7 days after the last TV-1106 or placebo injection.~The outcome as defined in the protocol was the within-patient change from baseline to week 24. Due to the early termination of the study, endpoint values are also reported. Endpoint values are the last observed post-baseline value in the Core Period, and are reported for participants who had not reached Week 24."|Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period (last post-baseline value prior to Week 24)|ITT|||standard deviation score||Standard Deviation|Mean
2580115|NCT02410343|Secondary|Total Trunk Fat at Baseline, Week 24 and Endpoint in Core Period|"Trunk fat (kg) was assessed based on DXA results. Trunk fat was defined as fat mass - (total arm fat + total leg fat + total head fat). The outcome as defined in the protocol was the within-patient change from baseline to week 24 in trunk fat.~Due to the early termination of the study, endpoint values are also reported. Endpoint values are the last observed post-baseline value in the Core Period, and are reported for participants who had not reached Week 24."|Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period (last post-baseline value prior to Week 24)|ITT|||kg||Standard Deviation|Mean
2580116|NCT02410343|Primary|Body Fat Mass at Baseline, Week 24 and Endpoint in Core Period|The primary efficacy measure for the study was body fat mass (kg) measured by DXA imaging. The primary outcome as defined in the protocol was the change from baseline to week 24 in body fat mass. Due to the early termination of the study, endpoint values are also reported. Endpoint values are the last observed post-baseline value in the Core Period, and are reported for participants who had not reached Week 24.|Baseline (Day 1, pre-dose), Week 24, Endpoint in Core Period (post-baseline value prior to Week 24)|ITT|||kg||Standard Deviation|Mean
2580117|NCT02410291|Primary|Number of Participants Whom Had Proper Preparation After Education Intervention|patients will receive a questionnaire to assess their satisfaction of their appointment. CT scans will be assessed for compliance of preparation based on departmental guidelines and rescans required.|1 month (patients will be followed until their treatment is complete)||||participants|||Number
2580118|NCT02410278|Secondary|Percentage of Participants Who Experienced AEs Related to Flushing|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. Flushing-related AEs included flushing and hot flush. Only events with an onset date on or after the date of first DMF dose (up to 27 days before Day 0) are presented. This includes events present before and subsequently worsened after the first dose of DMF.|Day of first DMF dose (up to 27 days before Day 0) to Week 10|The MITT: All participants who were randomized, received at least 1 dose of DMF treatment, received at least 1 dose of study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period.|||percentage of participants|||Number
2580119|NCT02410278|Secondary|Percentage of Participants Who Discontinued DMF Therapy Due to GI-Related Adverse Events (AEs) From Day 0 to Week 10|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. Participants used an electronic diary to record GI-related events. GI-related AEs included diarrhea, nausea, upper abdominal pain, abdominal pain, and dyspepsia.|Day 0 to Week 10|The MITT: All participants who were randomized, received at least 1 dose of DMF treatment, received at least 1 dose of study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period.|||percentage of participants|||Number
2580120|NCT02410278|Secondary|Percentage of Participants Who Required GI Symptomatic Therapy During the Study|Symptomatic therapies were not permitted during the first 10 days after starting montelukast or placebo. From Day 10 onward, participants were allowed to use the following symptomatic therapies to treat DMF-related GI events: bismuth subsalicylate, simethicone, calcium carbonate, loperamide, proton-pump inhibitors and ondansetron.|Day 10 to Week 10|The MITT: All participants who were randomized, received at least 1 dose of DMF treatment, received at least 1 dose of study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period.|||percentage of participants|||Number
2580139|NCT02410200|Primary|Change in the Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans From the Baseline Period to On-Treatment Assessment Period||Baseline Period (Week -8 to Day 0), On-Treatment Assessment Period (Week 16 to Week 24)|Primary Analysis Population: participants having new or newly enlarging T2 lesions during the Baseline period with a post-baseline assessment.|||lesions||Standard Deviation|Mean
2580140|NCT02410161|Secondary|Insulin Concentration in Plasma|Insulin measured in plasma in average during the metabolic study day, measured hourly between 0 ans 6 h after breakfast|after 4 weeks||||µIU/mL||Standard Error|Mean
2580141|NCT02410161|Secondary|Plasma Free Fatty Acids|Free fatty acids measured in plasma in average during the metabolic study day, measured hourly between 1 to 6h after breakfast|4 weeks||||mmol/L||Standard Error|Mean
2580142|NCT02410161|Secondary|Plasma Triglycerides|Triglycerides measured in plasma in average during the metabolic study day, measured hourly between 1 to 6h after breakfast|After 4 weeks||||mmol/L||Standard Error|Mean
2580121|NCT02410278|Secondary|Average Change From Baseline in GSRS Overall Score at Day 0 to 72 Hours From the Initiation of Randomized Study Treatment|The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). This endpoint reports the average change from baseline (Day 0) at Day 1 to Day 3. Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 is the last day when the threshold was reached, prior to the first dose. A negative change from baseline indicates that symptoms decreased.|Baseline (Day 0), Day 3 (72 hours after Day 0)|The MITT: All participants who were randomized, received at least 1 dose of both DMF treatment and study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period. One participant in the MITT-Montelukast arm did not provide post-baseline data.|||units on scale||Standard Deviation|Mean
2580122|NCT02410278|Secondary|Average Change From Baseline in GSRS Overall Score at Day 1 to Weeks 1 to 8|The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). This endpoint reports the average change from baseline (Day 0) between Day 1 and the specified time point. Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 was the last day when the threshold was reached, prior to the first dose. A negative change from baseline indicates that symptoms decreased.|Baseline (Day 0), Day 1 (1 Day after Day 0), Weeks 1 to 8 (1-8 weeks after Day 0)|The MITT: All participants who were randomized, received at least 1 dose of DMF treatment, received at least 1 dose of study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period.|||unit on scale||Standard Deviation|Mean
2580123|NCT02410278|Secondary|Time to Recovery to Baseline GSRS Score From Last Occurrence of Worst GSRS Score at Day 1 to Week 8|The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). Recovery was defined as a GSRS score less than or equal to the Day 0 score. Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 was the last day when the threshold was reached, prior to the first dose. Time to recovery was defined as the date of recovery minus the date of the last occurrence of the worst score.|Baseline (Day 0), Day 1 (1 Day after Day 0) to Week 8 (8 weeks after Day 0)|The MITT: All participants who were randomized, received at least 1 dose of DMF treatment, received at least 1 dose of study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period.|||days||Inter-Quartile Range|Median
2580124|NCT02410278|Secondary|Time to First Worsening From Baseline in GSRS Overall Score at Day 1 to Day 10|The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 was the last day when the threshold was reached, prior to the first dose.. Time to the first worsening was defined as the number of days from Day 1 to the first date with a worsened GSRS score. Censoring occurred at Day 10.|Baseline (Day 0), Day 1 (1 day after Day 0) to Day 10 (10 days after Day 0)|The MITT: All participants who were randomized, received at least 1 dose of DMF treatment, received at least 1 dose of study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period.|||days||Inter-Quartile Range|Median
2580125|NCT02410278|Secondary|Average Change From Baseline in GSRS Overall Score at Day 1 to Week 10|The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). This endpoint reports the average change from baseline (Day 0) between Day 1 and Week 10. Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 was the last day when the threshold was reached, prior to the first dose. A negative change from baseline indicates that symptoms decreased.|Baseline (Day 0), Day 1 (1 day after Day 0), Week 10 (10 weeks after Day 0)|The MITT: All participants who were randomized, received at least 1 dose of DMF treatment, received at least 1 dose of study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period.|||units on scale||Standard Deviation|Mean
2580143|NCT02410161|Secondary|Plasma Glucose|Glucose measured in plasma in average during the metabolic study day, measure hourly between 0 and 6 h after breakfast|After 4 weeks||||mmol/L||Standard Error|Mean
2580144|NCT02410161|Primary|Ketone Production|Total Ketone (acetoacetate + beta-hydroxybutyrate) concentration in plasma in average during the metabolic study day, measured hourly between 1 and 6h after breakfast|After 4 weeks||||µmol/L||Standard Error|Mean
2581256|NCT02395055|Primary|Maximum Concentration of Adalimumab After Single SC Injection of BCD-057/Humira||0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose|All patients who received one injection of adalimumab.|||ng/ml||Inter-Quartile Range|Median
2580126|NCT02410278|Secondary|Average Change From Baseline in GSRS Overall Score at Day 1 to Day 10|The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). This endpoint reports the average change from baseline (Day 0) at Day 1 to Day 10. Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 was the last day when the threshold was reached, prior to the first dose. A negative change from baseline indicates that symptoms decreased.|Baseline (Day 0), Day 1 (1 day after Day 0), Day 10 (10 days after Day 0)|The MITT: All participants who were randomized, received at least 1 dose of DMF treatment, received at least 1 dose of study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period.|||units on a scale||Standard Deviation|Mean
2580127|NCT02410278|Primary|Percentage of Participants With a Worsening in Severity of Gastrointestinal (GI) Adverse Events (AEs) on the GSRS From Day 0 to Day 10|The GSRS is a weekly recall scale that was modified for daily recall. The 15-question GSRS is summarized with a 7-point Likert scale: no discomfort at all=0; minor discomfort=1; mild discomfort=2; moderate discomfort=3; moderately severe discomfort=4; severe discomfort=5 and very severe discomfort=6. The overall GSRS score is a mean score that ranges from 0 (no symptoms) to 6 (the worst possible symptoms). Worsening in severity was defined as a positive average change from baseline (Day 0) to Day 10 in the GSRS score. Day 0: the day before a participant started randomized treatment (if the GI threshold was reached 1 day previously) or the first day of randomized treatment if the threshold was reached that day. If the threshold was reached >1 day previously, then Day 0 was the last day when the threshold was reached, prior to the first dose. Average change is the sum of changes from baseline in GSRS score over the first 10 days divided by the total of days with a GSRS score.|Baseline (Day 0), Day 10 (10 days after Day 0)|The MITT: All participants who were randomized, received at least 1 dose of DMF treatment, received at least 1 dose of study treatment (montelukast or placebo) on/after the first DMF dose date, and had at least 1 GSRS score measurement during the Day 1 – Day 10 period.|||percentage of participants|||Number
2580128|NCT02410252|Secondary|Usability, Acceptability and Satisfaction|This will be assessed by questionnaires specifically designed for this study. We will be assessing ease of use, acceptability, connection and use problems like the device falling off the skin, usefulness of out-of-range temperature alerts and adverse reactions. We will also assess to see if the device helps to build caregiver self-efficacy skills in caring for the patient.|2 weeks|Caregivers of participants using the device.|||Participants|||Count of Participants
2580129|NCT02410252|Secondary|Care Giver Anxiety|The Generalized Anxiety Disorder, 7 item questionnaire was given to caregivers to see if using the device increased feelings of anxiety. This will be assessed using the GAD-7 questionnaire administered at enrollment and closeout|0 & 2 weeks|Caregivers of participants using the device.|||Participants|||Count of Participants
2580130|NCT02410252|Primary|Percent of Participants That Successfully Used the iThermonitor|"This will be assessed by ability of the device to successfully capture, transmit and display the patient's body temperature data on the study iPod TouchiPad mini. To limit recall bias, subjects will be required to log the ability to view the temperature data on the iPad mini once a day for the entire duration of the study. The device will be deemed a feasible continuous temperature monitoring tool if at least 80% of study subjects are able to successfully use the iThermonitor to monitor their body temperature. A subject must be able to view temperature data on the provided iPad mini at least 80% of the time in the study to be considered successful. Time in the study here is defined as the number of days the subject spends in the study which is expected to be two weeks."|Two Weeks|Caregivers of participants using the device|||% of participants|||Number
2580131|NCT02410213|Primary|Maximum Serum Concentration (Cmax)|Maximum observed serum concentration; obtained directly from the serum concentration-time profile.|prior to dosing and 1, 2, 6, 12, 48 and 72 hours post dosing|In Cohort 1, pharmacokinetic parameter values are excluded for one subject due to anomalous and consistently high concentrations, and for one subject due to missing concentration data at 1 and 2 hours post-dose.|||µg/mL||Standard Deviation|Mean
2580132|NCT02410200|Secondary|Number of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.|Up to Week 28|All participants who received at least 1 dose of BG00012.|||participants|||Number
2580133|NCT02410200|Secondary|Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf)||Day 8|All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available.|||h*mcg/mL||Standard Deviation|Mean
2580134|NCT02410200|Secondary|Half-Life Lambda z||Day 8|All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available.|||hours||Standard Deviation|Mean
2580135|NCT02410200|Secondary|Apparent Volume of Distribution (V/F)||Day 8|All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available.|||L||Standard Deviation|Mean
2580136|NCT02410200|Secondary|Apparent Clearance (CL/F)||Day 8|All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available.|||L/h||Standard Deviation|Mean
2580137|NCT02410200|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 8|All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available.|||hours||Standard Deviation|Mean
2580138|NCT02410200|Secondary|Maximum Observed Plasma Concentration (Cmax)||Day 8|All participants who received at least 1 dose of BG00012 and had at least 1 pharmacokinetic parameter available.|||ng/mL||Standard Deviation|Mean
2580145|NCT02410018|Secondary|Inflammatory Response Assessed by Histology at 28 Days Post Treatment of Women With Leiomyomata by UAE|Inflammatory response assessed by histology at 28 days post treatment of women with leiomyomata by UAE - Perivascular Low Grade|28 days|Inflammatory response was conducted at 7-days post-embolization for Cohort 1 and 28-days for Cohort 2, post-embolization.|||Participants|||Count of Participants
2580146|NCT02410018|Secondary|Tissue Necrosis Assessed by Histology Graded Scale at 28 Days Post Treatment of Women With Leiomyomata by UAE|Tissue necrosis assessed by histology graded scale at 28 days post treatment of women with leiomyomata by UAE - Fibroid Necrosis|28 days|Histological assessment of uterine tissue was conducted at 7-days for Cohort 1 and 28-days for Cohort 2, post-embolization.|||Participants|||Count of Participants
2580147|NCT02410018|Secondary|Inflammatory Response Assessed by Histology at 7 Days Post Treatment of Women With Leiomyomata by UAE|Inflammatory response assessed by histology at 7 days post treatment of women with leiomyomata by UAE - Perivascular inflammation - Low Grade|7 days|Inflammatory response for Cohort 1 was assessed at 7-days, post-embolization. Inflammatory response for Cohort-2 was assessed at 28-days, post-embolization.|||Participants|||Count of Participants
2580148|NCT02410018|Secondary|Tissue Necrosis Assessed by Histology Graded Scale at 7 Days Post Treatment of Women With Leiomyomata by UAE|Tissue necrosis assessed by histology at 7 days post treatment of women with leiomyomata by UAE - Fibroid necrosis observed|7 days|Histological assessment of uterine tissue was conducted for Cohort 1 at 7-days, post-embolization. Histological assessment of uterine tissue was conducted for Cohort 2 at 28-days, post-embolization.|||Participants|||Count of Participants
2580149|NCT02410018|Primary|Change in Fibroid Perfusion From Baseline at 28 Days Post Treatment of Women With Leiomyomata by UAE|Number of participants with decreased fibroid perfusion from baseline at 28 days post treatment of women with leiomyomata by UAE.|Baseline and 28 days|Decrease in fibroid perfusion|||Participants|||Count of Participants
2580150|NCT02410018|Primary|Number of Participants With Serious Adverse Events|Short-term safety of OCL 503 at 28 days post treatment of women with leiomyomata by UAE, as measured by Adverse Events reporting - Serious Adverse Events|28 days||||Participants|||Count of Participants
2580151|NCT02410018|Primary|Change in Fibroid Perfusion From Baseline at 7 Days Post Treatment|Number of participants with decreased fibroid perfusion from baseline at 7 days post treatment of women with leiomyomata by UAE - Decreased Fibroid Perfusion Fibroid perfusion indicative of blood flowing to the fibroid at baseline and 7 days after embolization was determined using MRI.|Baseline and 7 days||||Participants|||Count of Participants
2580152|NCT02410018|Primary|Number of Participants With Serious Adverse Events|Short-term safety of OCL 503 at 7 days post treatment of women with leiomyomata by UAE, as measured by Adverse Events reporting - Serious Adverse Events|7 days||||Participants|||Count of Participants
2580153|NCT02409927|Secondary|Number of Participants With Side Effects for Each Visit|If participant had any side effect (mild or moderate) at least one time during the day.|During the 4 hours following intake of supplement||||Participants|||Count of Participants
2580154|NCT02409927|Secondary|Plasma Insuline Concentration|Average of insulin measured evey 30 minutes during the 4 hours of each metabolic day|average of 4 hours following intake of supplement||||µIU/mL||Standard Error|Mean
2580155|NCT02409927|Secondary|Plasma Free Fatty Acids Concentration|average of free fatty acids measured every 30 minutes during the four hour fo each metabolic day|average of 4 hours following intake of supplement||||µmol/L||Standard Error|Mean
2580156|NCT02409927|Secondary|Plasma Glucose Concentration|average of glucose measured every 30 minutes during the four hour of each metabolic day|Average of every 30 minutes for 4 hours following intake of supplement||||mmol/L||Standard Error|Mean
2580157|NCT02409927|Primary|Plasma Ketone Concentration|Average of total ketones (beta-hydroxynutyrate + acetoacetate) measured in plasma, measured every 30 minutes for hours following intake of the different supplements|Average of every 30 minutes for 4 hours following intake of supplement||||µmol/L||Standard Error|Mean
2580158|NCT02409914|Primary|Insulin Resistance (HOMA2-IR)|The homeostasis model assessment computational method was used to estimate insulin resistance (HOMA2-IR) from fasting plasma glucose and insulin. The HOMA2-IR is the reciprocal of insulin sensitivity (%S), as a percentage of a normal reference population (normal young adult). A higher score indicates a lower insulin sensitivity.|Single point in time (day 1 during the FDG PET)||||HOMA2-IR score||Standard Deviation|Mean
2580159|NCT02409914|Primary|Brain MR Volumes|T1-weighted brain MR images were obtained on a 1.5 Tesla scanner. Regional volumes were determined using FreeSurfer Suite 5.0 software.|Single point in time (day 2)||||ml||Standard Deviation|Mean
2580160|NCT02409914|Primary|Global Brain Glucose PET Uptake|Global brain glucose uptake was quantified using FDG with dynamic positron emission tomography.|Single point in time (day 1)||||umol/100 g/min||Standard Deviation|Mean
2580161|NCT02409784|Primary|Mean in Cerebral Metabolic Rate of Glucose Before or After 4 Days of Ketogenic Diet||At baseline (approximatively 1 month before the onset of the diet) and right after a 4 days ketogenic diet||||µmol/100g/min||Standard Error|Mean
2580162|NCT02409784|Primary|Mean in Cerebral Metabolic Rate of Acetoacetate Before or After 4 Days of Ketogenic Diet||At baseline (approximatively 1 month before the onset of the diet) and right after a 4 days ketogenic diet||||µmol/100g/min||Standard Error|Mean
2580163|NCT02409732|Secondary|Number of Participants With Adverse Events|Evaluation of any reported local or systemic events outside the treatment area and other than those specified under local skin reactions or PDT reactions.|Baseline to Week 36||||Participants|||Count of Participants
2580164|NCT02409732|Secondary|The Number of Participants Who Developed a Local Skin Reaction to Blue Light Treatment: Vesiculation/Pustulation, Erosion/Ulceration, Crusting and Hyperpigmentation|Assessments of vesiculation/pustulation, erosion/ulceration, and crusting were conducted immediately after each blue light treatment using a five-point ordinal scale (0: none to 4: severe). The presence or absence of hyperpigmentation in the treatment area was also documented after each treatment visit. The total number of participants who developed a local skin reaction is documented.|Baseline to Week 36|Twenty participants completed 50 treatments and the change in local skin reaction (pre-treatment, during treatment and post-treatment) was evaluated at each visit.|||participants|Treatment visits||Number
2581321|NCT02393950|Secondary|Sedation Scores on a Visual Analogue Scale (VAS)|Assessment of sedation by subject|Pre-dose and at 1, 6 and 10.5h post dose at each dose level|||||||
2580165|NCT02409732|Secondary|Average Change in Local Skin Reactions to Blue Light Treatment|Assessments of swelling, erythema, and flaking/scaling were conducted after each treatment and two days post-treatment using a five-point ordinal scale (0: none to 4: severe). The average change in swelling, erythema and flaking/scaling after each treatment and two days post treatment were divided by the 50 total treatments to obtain the average value.|Baseline to Week 36|Twenty participants completed 50 treatments and the change in local skin reaction (pre-treatment, during treatment and post-treatment) was evaluated at each visit.|||units on a scale|Treatment visits|Full Range|Mean
2580166|NCT02409732|Secondary|Average Change in Participant Reported Pain|Subject reported pain before, during and after blue light illumination was documented using a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst pain imaginable). The maximum change in pain is 10 for each occurrence (pain before compared to during treatment and pain during compared to after treatment). This is multiplied by the number of subjects and then divided by the number of treatments to generate the range. The summation of the change between subject reported pain prior to compared to during blue light treatment was divided by the total number of treatments to obtain the average value. The summation of the change between subject reported pain during compared to after blue light treatment was divided by the total number of treatments to obtain the average value.|Baseline to Week 36|"Twenty participants completed 50 treatments and the change in local skin reaction (pre-treatment, during treatment and post-treatment) was evaluated at each visit.~Number of Patients by Number of Treatments received:~One Treatment: 4 Two Treatments :2 Three Treatments:14"|||units on a scale|Treatment visits|Full Range|Mean
2580167|NCT02409732|Primary|Number of Participants With a Change in Clearance From Baseline|Clearance will be estimated clinically as minimal (0%-25%), mild (26%-50%), moderate (51%-75%), good (76%-99%), or complete (100%). Results will also be evaluated by comparing photographs before and immediately after treatments, and 12 and 24 weeks after the last treatment.|Visit 2 (Baseline) to Visit 5 or 6 (Week 24 or 36)|Twenty patients were enrolled into the study. Please see baseline characteristics to understand the patient demographic.|||Participants|||Count of Participants
2580168|NCT02409719|Other Pre-specified|Oxford Knee Score (OKS)|"The Oxford Knee Score is a 12-item patient-reported outcome specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty). It is short, reproducible, valid and sensitive to clinically important changes.~Consists of 12 multiple choice questions consisting of five answers with a maximum score of 60.~Score ranges~Score 0 to 19: May indicate severe knee arthritis. It is highly likely that you may well require some form of surgical intervention, contact your family physician for a consult with an Orthopaedic Surgeon.~Score 20 to 29: May indicate moderate to severe knee arthritis. See your family physician for an assessment and x-ray. Consider a consult with an Orthopaedic Surgeon.~Score 30 to 39: May indicate mild to moderate knee arthritis. Consider seeing your family physician for an assessment and possible x-ray. You may benefit from non-surgical treatment, such as exercise, weight loss, and /or anti-inflammatory med"|up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)||||units on a scale||Standard Deviation|Mean
2580169|NCT02409719|Secondary|Visual Analog Scale (Measure of Pain Intensity)|"The pain Visual Analog Scale is a unidimensional measure of pain intensity. The scale is most commonly anchored by no pain  (score of 0) and pain as bad as it could be or worst imaginable pain (scale of 10)."|up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)||||score on a scale||Standard Deviation|Mean
2580170|NCT02409719|Primary|Total WOMAC Score|"The total score is provided for Western Ontario and McMaster Universities Arthritis Index (WOMAC).~It is a widely score used in the evaluation of Hip and Knee Osteoarthritis. Consists of a self-administered questionnaire consisting of 24 items divided into 3 subscales:~pain (5 items), stiffness (2 items), and physical functioning (17 items) of the joints.~Scale Range: 5 items of pain (score range 0-20), 2 items for stiffness (score range 0-8), and 17 items for functional limitation (score range 0-68). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Total WOMAC score range 0-96.~For each subscale higher values represent worse outcomes.~Subscales are summed for a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.~WOMAC Index was developed in 1982 at Western Ontario and McMaster Universities."|up to 12 months (O, 2, 4, 6 weeks, 3,6 and 12 months)||||score on a scale||Standard Deviation|Mean
2580171|NCT02409667|Secondary|Change From Baseline in the EQ-5D Utility Index (Germany, UK) in Participants With a PASI Response of ≥75 to <90 at Week 24|"The EQ-5D quantifies the health state of a patient for the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. In the current study the EQ-5D-5L version has been used which evaluates each of these dimensions using the following five labels: no problems, slight problems, moderate problems, severe problems and unable to/extreme problems.~Based on the five dimensions, a summary score (utility index) was derived using country specific value sets evaluating the patient condition described by the outcome in the single dimensions. For this trial, the EQ-5D-5L utility index based on the crosswalk value sets available from the EuroQol for Germany and for UK (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/) was calculated.~A visual analogue scale (VAS) was used within the EQ-5D measuring the health state of the patients, ranging from 0 (=worst imaginable health state) up to 100 (=best imaginable health state)."|Baseline, Week 52|Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.|||score on a scale||Standard Deviation|Mean
2580182|NCT02409667|Secondary|Change From Baseline in PASI in Participants With a PASI 90 Response at Week 24|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative change from baseline indicates improvement.|Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52|Only participants from the FAS-P90R, who had evaluable data at both baseline and the post-baseline time point, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.|||score on a scale||Standard Deviation|Mean
2580172|NCT02409667|Secondary|Change From Baseline in the EQ-5D Utility Index (Germany, United Kingdom (UK)) in Participants With a PASI 90 Response at Week 24|"The EQ-5D quantifies the health state of a patient for the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort & anxiety/depression. In this study the EQ-5D-5L version has been used which evaluates each of these dimensions using the following 5 labels: no problems, slight problems, moderate problems, severe problems & unable to/extreme problems. Based on the 5 dimensions, a summary score (utility index) was derived using country specific value sets evaluating the patient condition described by the outcome in the single dimensions. The EQ-5D-5L (in this trail) utility index based on the crosswalk value sets available from the EuroQol for Germany & UK (https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/) was calculated. A positive change from baseline indicates improvement.~A visual analogue scale was used within the EQ-5D measuring the health state of the patients, ranging from 0 (worst imaginable health state) up to 100 (best imaginable health state)."|Baseline, Week 52|Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.|||score on a scale||Standard Deviation|Mean
2580173|NCT02409667|Secondary|Change From Baseline in the EQ-5D VAS in Participants With a PASI Response of ≥75 to <90 at Week 24|"A visual analogue scale (VAS) was used within the EQ-5D. This scale recorded the respondent's self-rated health on a vertical 20-cm VAS where the endpoints were labeled best imaginable health state and worst imaginable health state. This resulted in a numeric value set ranging from 0 (=worst imaginable health state) up to 100 (=best imaginable health state)."|Baseline, Week 52|Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.|||score on a scale||Standard Deviation|Mean
2580174|NCT02409667|Secondary|Change From Baseline in the European Quality of Life - 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) in Participants With a PASI 90 Response at Week 24|"A visual analogue scale (VAS) was used within the EQ-5D. This scale recorded the respondent's self-rated health on a vertical 20-cm VAS where the endpoints were labeled best imaginable health state and worst imaginable health state. This resulted in a numeric value set ranging from 0 (=worst imaginable health state) up to 100 (=best imaginable health state). A positive change from baseline indicates improvement."|Baseline, Week 52|Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.|||score on a scale||Standard Deviation|Mean
2580175|NCT02409667|Secondary|Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI Response of ≥75 to <90 at Week 24|Self-administered, 11-point numeric rating scales (NRS, 0-10) were used to evaluate the patients' assessment of their current pain, itching and scaling. Respondents answered the following questions for the assessment: Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours?; Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours?; and Scaling: Overall, how severe was your psoriasis-related scaling over the past 24 hours? Patients had to rate their pain, itching, and scaling from 0 to 10 (11-point scale), with the understanding that the 0 represents the absence or null end of the pain, itching, or scale intensity (i.e. no pain, itching or scaling) and the 10 represents the other extreme of pain, itching, or scaling intensity (i.e. pain, itching or scaling as bad as it could be). The number that the patient selected represents his or her intensity score in the respective category. A negative change from baseline indicates improvement|Baseline, Week 52|Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.|||score on a scale||Standard Deviation|Mean
2580176|NCT02409667|Secondary|Change From Baseline in Pain, Itching and Scaling Score in Participants With a PASI 90 Response at Week 24|Self-administered, 11-point numeric rating scales (NRS, 0-10) were used to evaluate the patients' assessment of their current pain, itching and scaling. Respondents answered the following questions for the assessment: Pain: Overall, how severe was your psoriasis-related pain over the past 24 hours?; Itching: Overall, how severe was your psoriasis-related itch over the past 24 hours?; and Scaling: Overall, how severe was your psoriasis-related scaling over the past 24 hours? Patients had to rate their pain, itching, and scaling from 0 to 10 (11-point scale), with the understanding that the 0 represents the absence or null end of the pain, itching, or scale intensity (i.e. no pain, itching or scaling) and the 10 represents the other extreme of pain, itching, or scaling intensity (i.e. pain, itching or scaling as bad as it could be). The number that the patient selected represents his or her intensity score in the respective category. A negative change from baseline indicates improvement|Baseline, Week 52|Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.|||score on a scale||Standard Deviation|Mean
2580192|NCT02409459|Secondary|Change in BPI, Pain Interference|The short version of the Brief Pain Inventory (BPI) includes front and back body diagrams, 4 pain severity items and 7 pain interference items rated on 0-10 scales (with 0 being the best outcome and 10 being the worst outcome), and a question about percentage of pain relief by analgesics. The Pain Interference Score is calculated by adding the scores for the 7 pain interference questions and then dividing by 7 to give a score out of 10.|Change from Baseline in Brief Pain Inventory Pain Interference Score at Day 42|Patients without a particular measure at a required time point were excluded from the analysis of that measure.|||units on a scale||Standard Deviation|Mean
2580193|NCT02409459|Primary|Proportion of Patients With a ≥13 Point Improvement in FIQR Score|The primary efficacy endpoint was the percentage of subjects who had a ≥13-point improvement in the FIQR from baseline to Day 42.|Day 42|The Safety population consisted of all subjects who received at least one dose of randomized treatment. The Efficacy Evaluable Population consisted of all subjects who received at least 1 dose of randomized treatment with at least 1 completed post treatment FIQR evaluation.|||Participants|||Count of Participants
2580177|NCT02409667|Secondary|Change From Baseline in WPAI-PSO Score in Participants With a PASI Response of ≥75 to <90 at Week 24|The WPAI-PSO is a self-administered questionnaire comprised of 6 questions about effects of psoriasis on the patient's ability to work and perform regular activities based on the previous 7 days. The questionnaire quantifies the number of hours the respondent was unable to work and evaluates how much the respondent's psoriasis affected productivity while working. For respondents who were not in paid employment, the questionnaire evaluated how much the respondent's psoriasis affects their ability to perform regular daily activities. Four outcomes were generated from the WPAI-PSO: % Absenteeism: percent work time missed due to health; % Presenteism: percent impairment while working due to health; % Total work productivity impairment: percent overall work impairment due to health; % Total activity impairment: percent activity impairment due to health for all respondents. First 3 outcomes applied to employed participants only. A negative change from baseline indicates improvement.|Baseline, Week 52|Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.|||score on a scale||Standard Deviation|Mean
2580178|NCT02409667|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Psoriasis (WPAI-PSO) Score in Participants With a PASI 90 Response at Week 24|The WPAI-PSO is a self-administered questionnaire comprised of 6 questions about effects of psoriasis on the patient's ability to work and perform regular activities based on the previous 7 days. The questionnaire quantifies the number of hours the respondent was unable to work and evaluates how much the respondent's psoriasis affected productivity while working. For respondents who were not in paid employment, the questionnaire evaluated how much the respondent's psoriasis affects their ability to perform regular daily activities. Four outcomes were generated from the WPAI-PSO: % Absenteeism: percent work time missed due to health; % Presenteism: percent impairment while working due to health; % Total work productivity impairment: percent overall work impairment due to health; % Total activity impairment: percent activity impairment due to health for all respondents. First 3 outcomes applied to employed participants only. A negative change from baseline indicates improvement.|Baseline, Week 52|Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.|||score on a scale||Standard Deviation|Mean
2580179|NCT02409667|Secondary|Change From Baseline in DLQI in Participants With a PASI Response of ≥75 to <90 at Week 24|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Baseline, Week 52|Participants from the FAS-P75R, who had evaluable data at both baseline and week 52, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.|||score on a scale||Standard Deviation|Mean
2580180|NCT02409667|Secondary|Change From Baseline in DLQI in Participants With a PASI 90 Response at Week 24|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Baseline, Week 52|Only participants from the FAS-P90R, who had evaluable data at both baseline and week 52, were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.|||score on a scale||Standard Deviation|Mean
2580181|NCT02409667|Secondary|Change From Baseline in PASI in Participants With a PASI Response of ≥75 to <90 at Week 24|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative change from baseline indicates improvement.|Baseline, Weeks 28, 32, 36, 40, 44, 48 and 52|Participants from the FAS-P75R, who had evaluable data at both baseline and the post-baseline time point, were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at Week 24, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after Week 24.|||score on a scale||Standard Deviation|Mean
2580194|NCT02409355|Primary|Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)||Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years)|The study was closed due to low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC into the GO29431 study. The planned outcome measures of this study are no longer applicable. The outcome measures were removed in the last protocol version.||||||
2580403|NCT02406586|Secondary|Change in Augmentation Index (AIx)|AIx is a surrogate measure of peripheral arterial resistance and is measured by analysis of the pulse wave at the radial artery. The AIx is calculated as the ratio of the pulse pressure at the second systolic peak to that at the first systolic peak. Change is the difference between 6-week AIx from baseline AIx.|Baseline, 6 weeks|not assessed (limited funds available)||||||
2580183|NCT02409667|Secondary|PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 52|Only participants from the FAS-P75R with evaluable data were analyzed. FAS-P75R: All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at the Week 24 visit, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after visit Week 24.|||Participants|||Count of Participants
2580184|NCT02409667|Secondary|PASI 50, PASI 75, PASI 100 and IGA Mod 2011 0 or 1 Responders at Week 52 in Participants With a PASI 90 Response at Week 24|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|week 52|Only participants from the FAS-P90R with evaluable data were analyzed. The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.|||Participants|||Count of Participants
2580185|NCT02409667|Secondary|Key Secondary: PASI 90 Response Rate at Week 52 in Participants With a PASI Response of ≥75 to <90 at Week 24|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Week 52|FAS for Treatment Period 2 of PASI 75 responders who did not achieve a PASI 90 response (FAS-P75R): All participants who were rated as PASI 75 responders but did not achieve a PASI 90 response at the Week 24 visit, were randomized to treatment groups 3 or 4 and who received at least one dose of study drug at or after visit Week 24.|||Participants|||Count of Participants
2580186|NCT02409667|Primary|Maintenance of PASI 90 Response at Week 52 in Participants With a PASI 90 Response at Week 24|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Week 52|Full analysis set for Treatment Period 2 of PASI 90 responders (FAS-P90R): The FAS-P90R included all participants who were rated as PASI 90 responders at the Week 24 visit, randomized to treatment groups 1 or 2 and received at least one dose of study drug at or after visit Week 24.|||Participants|||Count of Participants
2580187|NCT02409459|Secondary|Change in Iron Indices - Transferrin Saturation||Change from baseline in Iron Indices, Transferrin saturation, at Day 42|Patients without a particular measure at a required time point were excluded from the analysis of that measure.|||percent of transferrin saturation||Standard Deviation|Mean
2580188|NCT02409459|Secondary|Change in Iron Indices, Serum Ferritin||Change from Baseline in Iron Indices, Serum ferritin at Day 42|Patients without a particular measure at a required time point were excluded from the analysis of that measure.|||ug/L||Standard Deviation|Mean
2580189|NCT02409459|Secondary|Change in Fatigue Visual Numeric Scale|Scores range from 0 to 10, with the higher score indicating more fatigue.|Change from Baseline in Fatigue Visual Numeric Scale at Day 42|Patients without a particular measure at a required time point were excluded from the analysis of that measure.|||units on a scale||Standard Deviation|Mean
2580190|NCT02409459|Secondary|Change in BPI, Pain Severity|The short version of the Brief Pain Inventory (BPI) includes front and back body diagrams, 4 pain severity items and 7 pain interference items rated on 0-10 scales (with 0 being the best outcome and 10 being the worst outcome), and a question about percentage of pain relief by analgesics. The Pain Severity Score is calculated by adding the scores for the 4 pain severity questions and then dividing by 4 to give a severity score out of 10.|Change from Baseline in Brief Pain Inventory Pain Severity Score at Day 42|Patients without a particular measure at a required time point were excluded from the analysis of that measure.|||units on a scale||Standard Deviation|Mean
2580191|NCT02409459|Secondary|Change in FIQR Score|The FIQR has 21 individual questions. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst' and all questions are framed in the context of the past 7 days. The summed score for function (range 0 to 90) is divided by 3, the summed score for overall impact (range 0 to 20) is not changed, and the summed score for symptoms (range 0 to 100) is divided by 2. The total FIQR is the sum of the three modified domain scores.|Change from Baseline in FIQR score at Day 42|Patients without a particular measure at a required time point were excluded from the analysis of that measure.|||units on a scale||Standard Deviation|Mean
2584410|NCT02356588|Secondary|Analysis of Total Number of Doses Used During the 12-Hour Study Period in the ITT Population||Cumulative through 12 hours||||mean number of tablets taken||Standard Deviation|Mean
2580195|NCT02409277|Secondary|Oral Steroid Use, e-AT vs Usual Care|Non randomized comparison of use of oral steroid between e-AT interventions (both intensive and standard) compared usual care (matched control patients drawn from non-participating clinics) in the prior vs. post e-AT intervention time periods.|1 year|Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) e-AT participants and 599 matched controls retrieved electronically from non-participating clinics.|||Rate per 1000-days||Standard Deviation|Mean
2580196|NCT02409277|Secondary|ED/Hospital Admissions, e-AT vs Usual Care|Non randomized comparison of ED and hospital admissions between e-AT interventions (both intensive and standard) compared usual care (matched control patients drawn from non-participating clinics) in the prior vs. post e-AT intervention time periods.|1 year|Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) e-AT participants and 599 matched controls retrieved electronically from non-participating clinics.|||Rate per 1000-days||Standard Deviation|Mean
2580197|NCT02409277|Secondary|Oral Steroid Use, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Started the e-AT)|Use of oral steroid was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Statistical analysis was not conducted since the numbers of ED/Hospital admissions was very small (2 and 0) in both group (during the 3 months study window). Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants|3 month period prior to the late clinics starting the e-AT|Intent-to-treat analysis was used, including all 325. Randomized comparisons compared intensive vs. standard e-AT, but not e-AT efficacy vs usual care. This nonrandomized analysis (Early vs Late Clinics) assesses e-AT efficacy, comparing outcomes between “period” clinics were under the e-AT vs “periods” other clinics were not using the e-AT.|||number of oral steroid use|||Number
2580198|NCT02409277|Secondary|ED/Hospital Admission, Early vs Late Starting Clinics (During the 3 Months When Late Starting Clinics Have Not Used the e-AT)|ED and hospital admission evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. Statistical analysis was not conducted since the numbers of ED/Hospital admissions was very small (2 and 0) in both group (during the 3 months study window). Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants.|3-month period prior to the late clinics starting the e-AT|Intent-to-treat analysis was used, including all 325. Randomized comparisons compared intensive vs. standard e-AT, but not e-AT efficacy vs usual care. This nonrandomized analysis (Early vs Late Clinics) assesses e-AT efficacy, comparing outcomes between “period” clinics were under the e-AT vs “periods” other clinics were not using the e-AT.|||number of ED/Hospital admission|||Number
2580199|NCT02409277|Secondary|Oral Steroid Use, Early vs. Late Patients|"Oral steroid use data was collected through Intermountain Healthcare claims data and clinics prescribing oral steroid.~Oral steroid use was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Analyses (at the patient level) comparing the rates oral steroid use between a 1 year period following initiation of the e-AT for those in both standard and intensive e-AT groups who were enrolled early during the study period (patients with enrollment dates between January 2014 and December 2014) to rates of oral steroid use for patients who started the e-AT later (patients with enrollment dates between January 2015 and December 2015), during a 1-year period prior to the late patient starting the e-AT."|1 year|Intent-to-treat analysis was used, including all 325. Randomized comparisons compared intensive vs. standard e-AT, but not e-AT efficacy vs usual care. This nonrandomized analysis (Early vs Late Patients) assesses e-AT efficacy, comparing outcomes between “period” patients were under the e-AT vs “periods” other patients were not using the e-AT.|||number of oral steroid use||Standard Deviation|Mean
2580200|NCT02409277|Secondary|ED/Hospital Admission, Early vs. Late Patients|ED and hospital admission was evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters. Analyses (at the patient level) comparing the rates of ED/hospital admissions between a 1 year period following initiation of the e-AT for those in both standard and intensive e-AT groups who were enrolled early during the study period (patients with enrollment dates between January 2014 and December 2014) to rates of ED/hospital admissions for patients who started the e-AT later (patients with enrollment dates between January 2015 and December 2015), during a 1-year period prior to the late patient starting the e-AT.|1 year following e-AT use for early and late starting patients|Intent-to-treat analysis was used, including all 325. Randomized comparisons compared intensive vs. standard e-AT, but not e-AT efficacy vs usual care. This nonrandomized analysis (Early vs Late Patients) assesses e-AT efficacy, comparing outcomes between “period” patients were under the e-AT vs “periods” other patients were not using the e-AT.|||number of ED/Hospital admission||Standard Deviation|Mean
2580201|NCT02409277|Secondary|Use of Oral Steroid, Overall|Use of oral steroid was evaluated using data collected through Intermountain Healthcare claims data and oral steroids prescribed. Comparison was made between prior and post e-AT (both interventions) overall.|1 year|Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants|||number of oral steroid use||Standard Deviation|Mean
2580202|NCT02409277|Secondary|ED/Hospital Admissions, e-AT Overall (Pre vs. Post e-AT Use Within Subjects That Received the e-AT Intervention)|ED/hospital re-admission data were compared between prior and post 12 month period (for both intensive and standard interventions overall) when e-AT was administered.|1 year|Here we used intent-to-treat analysis and included the overall 325 (rather than 318 used in analysis of other outcomes) participants|||number of ED/hospital admission||Standard Deviation|Mean
2580203|NCT02409277|Secondary|Parent Interrupted/Missed Work Days, Overall (Longitudinal Change Overtime)|Number of parent interrupted/missed work days were collected longitudinally at the same time as collecting the QOL scores: Information includes mean at baseline, 3, 6, and 12 months in the study.|1 year|The numbers analyzed in the rows are different due to different number of participants completing the surveys throughout 3, 6, and 12 months. This was due to either compliance, withdrawal or loss to follow-up.|||Number of days (interrupted or missed)||Standard Deviation|Mean
2580404|NCT02406586|Secondary|Change in Oxidative Stress Markers.|Oxidative stress was measured by using liquid chromatography to collect plasma glutathione and glutathione disulfide. Change is the difference between 6-week plasma glutathione and glutathione disulfide from baseline plasma glutathione and glutathione disulfide.|Baseline, 6 weeks|not assessed (limited funds available)||||||
2580204|NCT02409277|Secondary|Child Interrupted/Missed School Days, Overall (Longitudinal Changes Overtime)|Number of child interrupted/missed school days were collected longitudinally (information includes mean at baseline, 3, 6, and 12 months in the study).|1 year|The numbers analyzed in the rows are different due to different number of participants completing the surveys throughout 3, 6, and 12 months. This was due to either compliance, withdrawal or loss to follow-up.|||Number of days (interrupted or missed)||Standard Deviation|Mean
2580205|NCT02409277|Secondary|Child Asthma Control Overall (Comparing Change of Asthma Control From Baseline to Quarter 1, Quarter 2, Quarter 3 and Quarter 4)|"Asthma control information was collected through the e-AT, comparing change of asthma control from baseline to quarter 1, quarter 2, quarter 3 and quarter 4.~Asthma control was measured using the Asthma Control Test (ACT), which scale ranged from 5-25, with 5=poorly controlled and 25=well controlled.~Each patient submitted an ACT score weekly for 12 months."|baseline ACT scores were compared to quarters 1, 2, 3, 4.|Patients were told to submit an ACT score once a week for 12 months. 311 patients completed at least one ACT score for a total number of 11418 ACT scores submitted using e-AT by all e-AT users (during study period).|||Score (points) ranging from 5-25|ACT scores|Standard Deviation|Mean
2580206|NCT02409277|Secondary|Parent Satisfaction With Care, Overall (Change Overtime From Baseline to 12 Months)|"Parent satisfaction data was collected using a modified version of patient satisfaction survey developed and validated by Varni et al. at baseline and at 12 months in the study.~The scale ranged from 1-5, with 1=Very Dissatisfied and 5=Very Satisfied."|Satisfaction at 1 year following e-AT use was compared to baseline satisfaction scores|We had 318 participants who have completed the baseline satisfaction survey, and 208 who completed 12 months follow-up survey, due to participants withdrawing from the study and loss to follow-up.|||units (points) on a scale (from 1-5)||Standard Deviation|Mean
2580207|NCT02409277|Secondary|Emergency Department (ED)/Hospitalization, Standard vs Intensive|"ED and hospital admissions were evaluated using data collected through Intermountain Healthcare claims data and ED visits and hospital encounters.~We evaluated number ED and hospital admissions 12 months prior to intervention and 12 months post intervention"|Change in 1 year ED/hospital admission between 12-month prior and 12 month post e-AT use|Number of pre- and post e-AT ED and hospital admissions were compared between standard and intensive groups.|||Number of ED/hospital admissions|||Number
2580208|NCT02409277|Secondary|Asthma Control Change, Standard vs Intensive|Asthma control information was collected weekly through the e-AT for 1 year. Asthma control was measured using the Asthma Control Test (ACT), which had a score ranging from 5 to 25, with 5 being poor control and 25 being optimal control. The analysis compared the mean change in scores from baseline to quarters 1, 2, 3, and 4.|Average baseline ACT scores compared to average ACT scores at quarter 1, 2, 3 and 4, and between Standard vs. Intensive||||mean score (points) change||Standard Error|Mean
2580209|NCT02409277|Secondary|Parent Interrupted/Missed Work Days, Standard vs Intensive|"Number of parent interrupted/missed work days were collected longitudinally at the same time as collecting the QOL scores: baseline, 3, 6, and 12 months in the study.~Number of parent interrupted/missed work days during the 3 months prior to baseline, 3, 6, and 12 months follow-up surveys were counted."|Interrupted/missed work days were measured baseline 3, 6, and 12 months|We had 261 Standard and 57 Intensive e-AT who completed baseline survey. Numbers in the row differ due to different number of participants who completed 3, 6, and 12 months surveys, due to participant compliance, withdrawal or loss-to-follow-up. 3, 6, and 12 month measurements were compared to Baseline, between Standard vs Intensive interventions|||Number of interrupted/missed work days|||Number
2580210|NCT02409277|Secondary|Child Interrupted/Missed School Days, Standard vs Intensive|"Number of child interrupted/missed school days were collected longitudinally at the same time as collecting the QOL scores: baseline, 3, 6, and 12 months in the study.~Number of child interrupted/missed school days during the 3 months prior to baseline, 3, 6, and 12 months follow-up surveys were counted."|Interrupted/missed school days were collected at baseline, 3, 6, and 12 month follow-ups|We had 261 Standard and 57 Intensive e-AT who completed baseline survey. Numbers in the row differ due to different number of participants who completed 3, 6, and 12 months surveys, due to participant compliance, withdrawal or loss-to-follow-up. 3, 6, and 12 month measurements were compared to Baseline, between Standard vs Intensive interventions|||Number of interrupted/missed school days|||Number
2580211|NCT02409277|Secondary|Parent Satisfaction With Care, Standard vs Intensive|"Parent satisfaction data was collected at baseline and at 12 months in the study.~The scale ranges from 1-5, with 1 being Very Dissatisfied and 5 Very Satisfied."|Changes in satisfaction was compared between 12 month follow-up and baseline satisfaction across Standard and Intensive interventions|We had 261 in Standard e-AT and 57 in Intensive e-AT who completed baseline survey, and 166 in Standard e-AT and 42 in Intensive e-AT completed the 12 Months Follow-up Survey. This is due to participant withdrawal and loss to follow-up.|||units (points) on a scale (from 1-5)||95% Confidence Interval|Mean
2580212|NCT02409277|Primary|Patient Quality of Life (QOL), Overall Longitudinal Change (From Baseline) Within All Subjects (Who Received the e-AT Intervention)|Patient QOL and missed school days was collected longitudinally through surveys of the study population defined above. The QOL questionnaire included the Integrated Therapeutics Group Child Asthma Short Form - ITG-CASF and was used at baseline (at first assessment), 3, 6, and 12 months in the study. Items within scales are summed and linearly transformed from 0 to 100, with higher scores indicating better functioning.|Average Baseline QOL was compared to QOL scores at 3, 6 and 12 month follow-up QOL|The numbers analyzed in the rows are different due to different number of participants completing the surveys throughout 3, 6, and 12 months. This was due to withdrawal from the study or loss to follow-up.|||units (points) on a scale, range 0-100||Standard Deviation|Mean
2580228|NCT02408523|Secondary|Seizure Freedom for Primary Generalized Tonic Clonic (PGTC) Seizures During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)|A seizure-free day from primary generalized tonic clonic seizures (PGTCS) was defined as a day where no PGTCS were reported in the seizure diary and PGTCS were assessed, which was estimated using Kaplan-Meier (KM) methods.|During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)|"The Full Analysis Set (FAS) was a subset of the Safety Set (SS) that consisted of all study participants with at least 1 seizure diary assessment during the Treatment Period.~1 patient from the Lacosamide (FAS) group was randomized after the 125th event and did not appear in this analysis."|||percentage of participants||95% Confidence Interval|Number
2599446|NCT02174523|Primary|Lurasidone Tmax||pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose|All subjects with evaluable PK data were included in PK data analysis.|||h||Full Range|Median
2580213|NCT02409277|Primary|Patient Quality of Life (QOL), Compared Mean QOL Change From Baseline at Each Follow-up Assessment Between the Clinics Assigned to the Intensive and Standard e-AT Interventions|"Patient QOL and missed school days was collected longitudinally through surveys of the study population defined above. The QOL questionnaire included the Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) and was used at baseline (at first assessment), 3, 6, and 12 months in the study.~Items within QOL scales are summed and linearly transformed from 0 to 100, with higher scores indicating better functioning."|Quality of Life assessed at baseline, then compared to 3 months, 6 months, and 12 months after intervention.|We enrolled 327, 2 clinics with only 1 patient enrolled were excluded, leaving 325 patients. Of 325, 7 did not provide baselines and were excluded, leaving 318 (261 standard vs. 57 intensive) participants. Row numbers differ due to different number of participants completing 3, 6, and 12 months follow-ups, due to withdrawal and loss to follow-up.|||Units on a scale||Standard Error|Mean
2580214|NCT02408965|Secondary|Number of Participants Who Reported Cramping up to One Hour After Procedure|Patients' completed survey regarding side effects in recovery room.|Assessed approximately 1 hour after procedure||||Participants|||Count of Participants
2580215|NCT02408965|Secondary|Number of Patients Who Reported Vomiting up to One Hour After Procedure|Patients' completed survey regarding side effects in recovery room.|Assessed approximately 1 hour after procedure||||Participants|||Count of Participants
2580216|NCT02408965|Secondary|Number of Participants Who Reported Nausea up to One Hour After Procedure|Patients' completed survey regarding side effects in recovery room.|Assessed approximately 1 hour after procedure||||Participants|||Count of Participants
2580217|NCT02408965|Primary|Number of Participants Given Any Uterotonic|any uterotonic medication given intraoperative or postoperative|intra-operative or post-operative until discharge||||Participants|||Count of Participants
2580218|NCT02408965|Primary|Number of Participants Who Were Admitted for Bleeding After Procedure|hospital admission for bleeding post-procedure|post-procedure and during recovery until discharge||||Participants|||Count of Participants
2580219|NCT02408965|Primary|Number of Participants Who Returned to OR for Re-aspiration During Recovery Period|Returned to OR for re-aspiration|from cervical preparation through discharge||||Participants|||Count of Participants
2580220|NCT02408965|Primary|Number of Participants Who Had a Balloon Tamponade Placed From Start of Procedure to Hospital Discharge|number of participants who had a balloon tamponade placed|duration of procedure and until discharged from hospital||||Participants|||Count of Participants
2580221|NCT02408965|Primary|Amount of Post-procedure Blood Loss Measured in mL|post-procedure blood loss measured in recovery room|measured 1 to 2 hours after procedure||||mL||95% Confidence Interval|Mean
2580222|NCT02408965|Primary|Number of Participants With Excessive Bleeding as Determined by the Composite Outcome Criteria|"Clinical factors included in composite outcome of excessive bleeding after D&E:~Post-procedure total blood loss > 125cc (after D&E) Transfusion Admission for bleeding Re-aspiration for bleeding Balloon tamponade Uterine artery embolization Major surgery for bleeding At least 1 uterotonic medication given Prescription given for any uterotonic medication at discharge Uterine compression (uterine massage or manual pressure for 2 minutes"|Approximately 1-2 hours after procedure||||Participants|||Count of Participants
2580223|NCT02408692|Secondary|Maximum Serum Concentration Between Obese BMI Women Ingesting 1.5mg of Levonorgestrel and Then the Same Obese BMI Women Ingesting 3mg Levonorgestrel|Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 3mg of levonorgestrel|Follicular phase of menstrual cycle||||ng/mL||Standard Deviation|Mean
2580224|NCT02408692|Primary|Maximum Serum Concentration Between Normal and Obese BMI Women Ingesting 1.5mg Levonorgestrel|Pharmacokinetic sampling at 0, 0.5, 1, 1.5, 2, and 2.5 hours were performed after ingestion of 1.5mg of levonorgestrel|Follicular phase of menstrual cycle and PK sampling at 0, 0.5, 1, 1.5, 2, 2.5||||ng/mL||Standard Deviation|Mean
2580225|NCT02408523|Secondary|Plasma Concentrations of Lacosamide|"Lacosamide plasma concentration was expressed in micrograms per milliliter (μg/mL).~Means and standard deviation (SD) were only calculated if at least 2/3 of the concentrations were quantified at the respective timepoint. Values Below Limit of Quantification (BLQ) were replaced by value of 0 in calculations of means and SDs."|During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)|The Safety Set (SS) was a subset of the Randomized Set (RS) and consisted of all study participants who had been treated with at least 1 dose of study medication, either LCM or Placebo.|||ug/mL||Standard Deviation|Mean
2580226|NCT02408523|Secondary|Percentage of Participants With at Least One Adverse Event (AE) as Reported Spontaneously by the Subject and/or Caregiver or Observed by the Investigator|An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational medicinal product (IMP), whether or not related to the IMP.|From Visit 1 (Week -4) to End of Study Period (up to Week 36)|The Safety Set (SS) was a subset of the Randomized Set (RS) and consisted of all study participants who had been treated with at least 1 dose of study medication, either LCM or Placebo.|||percentage of participants|||Number
2580227|NCT02408523|Secondary|Time to the First Primary Generalized Tonic Clonic (PGTC) Seizure During the Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)|The time to the first primary generalized tonic clonic seizure (PGTCS) during the 24-week Treatment Period was estimated using Kaplan-Meier (KM) methods.|During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)|"The Full Analysis Set (FAS) was a subset of the Safety Set (SS) that consisted of all study participants with at least 1 seizure diary assessment during the Treatment Period.~1 patient from the Lacosamide (FAS) group was randomized after the 125th event and did not appear in this analysis."|||events|||Number
2580229|NCT02408523|Primary|Time to the Second Primary Generalized Tonic Clonic (PGTC) Seizure During the 24-week Treatment Period From Visit 2 (Week 0) to Visit 10 (Week 24)|The primary efficacy variable was the time to the second primary generalized tonic clonic seizure (PGTCS) during the 24-week Treatment Period which was estimated using Kaplan-Meier (KM) methods.|During the Treatment Period from Visit 2 (Week 0) to Visit 10 (Week 24)|"The Full Analysis Set (FAS) was a subset of the Safety Set (SS) that consisted of all study participants with at least 1 seizure diary assessment during the Treatment Period.~1 patient from the Lacosamide (FAS) group was randomized after the 125th event and did not appear in this analysis."|||events|||Number
2580232|NCT02408445|Secondary|Change in Total Motor Standard Score on the Peabody Developmental Motor Scales 2|Motor development will be assessed by an occupational therapist using the standardized Peabody Developmental Motor Scales 2. Standard scores are normalized to age with a mean of 100 and standard deviation of 15. Change in standard score was calculated as the differences between the subject's standard score at 3 months minus the standard score at baseline. A positive change in standard scores would indicate greater growth on the measure relative to peers, while a negative number would indicate slower growth on the measure relative to peers.|3 months||||change in standard score||Standard Deviation|Mean
2580233|NCT02408445|Secondary|Change in Score on the Movement Assessment of Infants (MAI)|"Muscle tone and motor development will be assessed by an occupational therapist using the standardized Movement Assessment of Infants (MAI). The MAI evaluates four domains: muscle tone, primitive reflex, automatic reactions and volitional movement. All items are scored 1-5 and summed to generate a Total Risk Score. Lower scores indicate better function, and Total Risk Scores of 8 or more indicate high risk."|3 months|Data for this measurement was not collected for any of the participants.||||||
2580234|NCT02408445|Secondary|Change in Raw Score on the Alberta Infant Motor Scale|Muscle tone and motor development will be assessed by an occupational therapist using the standardized Alberta Infant Motor Scale (AIMS). The AIMS scale measures infant motor maturation from birth until the age of independent walking. An occupational therapists assesses 58 motor behavior items in 4 position categories: prone (21 items), supine (9 items), sitting (12 items) & standing(16 standing). Each item receives one point (range of raw scores 0-58), with higher scores indicating more skills acquired. For change in scores, the raw score at 3 months was subtracted from the baseline raw score.|3 months||||raw score||Standard Deviation|Mean
2580235|NCT02408445|Secondary|Leptin|Serum will be collected at the first study visit prior to randomization. Leptin levels will be measured.|baseline only|Unable to be analyzed due to insufficient quantities of serum collected. Prioritized hormone assays first.||||||
2580236|NCT02408445|Secondary|Serum Anti-Mullerian Hormone (AMH)|Serum will be collected at the first study visit prior to randomization. AMH levels will be measured.|baseline only|Analysis was completed only on subjects for which sufficient blood was able to be obtained and that has been measured at this time.|||pmol/l||Standard Deviation|Mean
2580237|NCT02408445|Secondary|Serum Inhibin B (INHB)|Serum will be collected at the first study visit prior to randomization. Inhibin B levels will be measured.|baseline only|Analysis was completed only on subjects for which sufficient blood was able to be obtained and that has been measured at this time.|||pg/ml||Standard Deviation|Mean
2580238|NCT02408445|Secondary|Serum Total Testosterone|Serum will be collected at the first study visit prior to randomization. Total testosterone by mass spectroscopy will be measured.|baseline only||||ng/dl||Standard Deviation|Mean
2580239|NCT02408445|Secondary|Serum Follicle Stimulating Hormone (FSH)|Serum will be collected at the first study visit prior to randomization. Ultrasensitive FSH will be measured.|baseline only|Analysis was completed only on subjects for which sufficient blood was able to be obtained and that has been measured at this time.|||mIU/mL||Standard Deviation|Mean
2580240|NCT02408445|Secondary|Serum Luteinizing Hormone (LH)|Serum will be collected at the first study visit prior to randomization. Ultrasensitive LH will be measured.|baseline only|Analysis was completed only on subjects for which sufficient blood was able to be obtained and that has been measured at this time.|||mIU/mL||Standard Deviation|Mean
2580241|NCT02408445|Primary|Change in Body Fat Percent Z-score|Body fat percentage will be measured using air displacement plethysmography (PEA POD) at the beginning and end of the study period. Age and sex-normed z-scores will be calculated. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Change in the z-score over time, if following a normal growth curve, is 0. Positive change in z-scores indicates a gain in body fat above growth typically expected. Negative change in z-scores indicates a gain in body fat that is less than typically expected.|Baseline and 3 months||||score on a scale||Standard Deviation|Mean
2580242|NCT02408315|Other Pre-specified|Participant Satisfaction|participant satisfaction with labor induction and preference for method of drug administration. This will use a questionnaire developed for this study with some similarity to the referenced Nassar study below.|from study entry until discharge- anticipated 5 days|||||||
2580243|NCT02408315|Other Pre-specified|Pharmacokinetic Profiling of Misoprostol|pharmacokinetic parameters (Area under the curve, half-life, maximum concentration) measured over first 2 study drug doses|from study entry until delivery- anticipated 3 days|||||||
2580244|NCT02408315|Secondary|Number of Participants With Neonatal Cord Gases Measured|cord gases from newborn|from study entry until delivery- anticipated 3 days||||Participants|||Count of Participants
2580245|NCT02408315|Secondary|Dose of Oxytocin Used for Augmentation|dose of oxytocin used for augmentation of labor|from study entry until delivery- anticipated 3 days||||milliunits per minute||Full Range|Median
2580246|NCT02408315|Secondary|Uterine Rupture|Presence of uterine rupture|from study entry until delivery- anticipated 3 days||||Participants|||Count of Participants
2580247|NCT02408315|Secondary|Number of Doses Misoprostol Used|Number of doses of misoprostol needed|from study entry until delivery- anticipated 3 days||||doses||Full Range|Median
2580248|NCT02408315|Secondary|Number of Neonatal Intensive Care Unit (NICU) Admission|Admission to NICU|from study entry until discharge of newborn- anticipated up to 28 days||||participants|||Number
2580249|NCT02408315|Secondary|Number of Participants Who Had Uterine Hyperstimulation|Presence of uterine hyperstimulation, tachysystole as defined as 6 uterine contractions in a 10 minute period|from study entry until delivery- anticipated 3 days||||Participants|||Count of Participants
2580250|NCT02408315|Secondary|Number of Vaginal Deliveries That Occurred Within 24 Hours|rate of achieving vaginal delivery within 24 hours|from study entry until delivery- anticipated 3 days||||Participants|||Count of Participants
2580251|NCT02408315|Primary|Number of Participants With Cesarean Deliveries Based on Fetal Non-Reassurance Indications|Rate of cesarean deliveries performed for fetal non-reassurance as the indication|from study entry until delivery- anticipated 3 days||||Participants|||Count of Participants
2580252|NCT02408315|Primary|Time to Delivery|"number of hours from placement of study drug to delivery~Cesarean delivery for fetal non--reassurance indication"|from study entry until delivery- anticipated 3 days||||hours||95% Confidence Interval|Median
2580256|NCT02408198|Primary|Green Paranoid Thoughts Scale (GPTS)|The GPTS consists of two 16-item scales. Ideas of reference (part A) and ideas of persecution (part B) are rated over the past month on a scale ranging from one (not at all) to five (totally). A total score is produced by summing all items for part A and B (minimum score = 32; maximum score = 160). A higher score indicates more paranoid thoughts.|Assessed at baseline, at 6 weeks and 10 weeks|A total of 18 participants were randomised. In the immediate therapy condition, 3 participants withdrew after baseline assessments and were not able to be contacted, 1 participant completed all assessments but did not feel able to attend the intervention. 1 participant was unable to complete all measures due to language difficulties and fatigue.|||score on a scale||Standard Deviation|Mean
2580257|NCT02408068|Primary|Bioavailability of Chronocort® vs Hydrocortisone Tablets - Fasted Using Tmax.|To evaluate the relative bioavailability of Chronocort® and immediate release hydrocortisone at a single dose of 20 mg in the fasted state using Tmax.|24 hours|PK population: All randomised subjects who had sufficient plasma concentration by time profiles for 2 adequate treatments and who did not violate the protocol in such a way that could invalidate or bias the results (major protocol violators).|||hours||Standard Deviation|Median
2580258|NCT02408068|Primary|Bioavailability of Chronocort® vs Hydrocortisone Tablets - Fasted Using AUC0-t|To evaluate the relative bioavailability of Chronocort® and immediate release hydrocortisone at a single dose of 20 mg in the fasted state using area under the curve|24 hours|PK population: All randomised subjects who had sufficient plasma concentration by time profiles for 2 adequate treatments and who did not violate the protocol in such a way that could invalidate or bias the results (major protocol violators).|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2580259|NCT02408068|Primary|Bioavailability of Chronocort® vs Hydrocortisone Tablets - Cmax|Evaluation of the relative bioavailability of Chronocort® and immediate release hydrocortisone at a single dose of 20 mg in the fasted state by Cmax|24 hours|PK population: All randomised subjects who had sufficient plasma concentration by time profiles for 2 adequate treatments and who did not violate the protocol in such a way that could invalidate or bias the results (major protocol violators).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2580260|NCT02408068|Primary|Comparison of Fed and Fasted Chronocort Tmax|Comparison of Fed and Fasted Chronocort based on the time to achive the maximum concentration of serum cortisol|24 hours|PK population: All randomised subjects who had sufficient plasma concentration by time profiles for 2 adequate treatments and who did not violate the protocol in such a way that could invalidate or bias the results (major protocol violators).|||hours||Standard Deviation|Median
2580261|NCT02408068|Primary|Comparison of Fed and Fasted Chronocort AUC0-t|"Area under the curve from 0 to 24 hours for serum cortisol. Please note that the AUC0-t will be presented as a single figure (geometric mean) to represent exposure over time.~N.B., the sampling points for Hydrocortisone are as follows: 0h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h and 12h post-dose. However, the results for Hydrocortisone will not be incorporated into the analysis for this outcome measure."|24 hours (at 0h, then 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h, 8h, 9h, 10h, 11h, 12h, 13h, 14h, 15h, 16h, 18h, 20h, 22h and 24h post-dose.)|PK population: All randomised subjects who had sufficient plasma concentration by time profiles for 2 adequate treatments and who did not violate the protocol in such a way that could invalidate or bias the results (major protocol violators).|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2580262|NCT02408068|Primary|Chronocort Cmax|Comparison of fed and fasted Chronocort Cmax for serum cortisol.|24 hours|PK population: All randomised subjects who had sufficient plasma concentration by time profiles for 2 adequate treatments and who did not violate the protocol in such a way that could invalidate or bias the results (major protocol violators).|||nmol/L||Geometric Coefficient of Variation|Geometric Least Squares Mean
2580263|NCT02407704|Secondary|Neurocognitive Function (Neuropsychological Battery)|The battery evaluates several cognitive domains. The Wechsler Adult Intelligence Scale, 4th ed. Digit Span subtest assesses attention and working memory. The Repeatable Battery of Neuropsychological Status (RBANS) measures Immediate and Delayed Memory, Attention, Language Abilities, and Visuospatial Functioning. Total index scores range from 40-155. The California Verbal Learning Test, 2nd Ed. (CVLT) assesses non-contextual verbal learning and memory. Z-scores are calculated for each of the constructs assessed by the CVLT. Subtests from the Deli-Kaplan Executive Function System (D-KEFS) assess aspects of executive functioning, including set-shifting (Trail Making Test Conditions 4 and 5: scaled score ranging from 0-19) and inhibition (Color-Word Interference Test Condition 3: weighted scaled score ranging from 1-19). Given that standardized scores are calculated for each of the neuropsychological measures, higher scores always indicate better cognitive functioning.|Baseline and 12 weeks|"1 participant in the Venlafaxine XR Only (20-39 Years) group was excluded from analyses as he/she was non-compliant with the medication regimen. Another participant in the Venlafaxine XR Only (60-79 Years of Age) was excluded from analyses as he/she was unable to complete Week 12 testing due to physical limitations."|||units on a scale||Standard Deviation|Mean
2580264|NCT02407704|Secondary|Functional Magnetic Resonance Imaging (fMRI)|Brain imaging conducted with a 7 Tesla scanner. Of particular interest were changes in hippocampal volume, GABA, and glutamate. The changes regarding hippocampal volumes are reported below. This measurement is reported in mm^3, with higher numbers indicating higher levels of gray matter in the hippocampal region. Volume is combined between right and left hemispheres. GABA and glutamate are not reported. The method used to obtain the data was being piloted for this study, and due to methodological challenges, the data is not considered to be accurate and therefore cannot be analyzed/shared.|Baseline and 12 weeks|2 participants were excluded from analyses due to lack of usable data at both time points.|||mm^3||Standard Deviation|Mean
2580317|NCT02407236|Secondary|Induction Study - Number of Participants With Normalized Fecal Lactoferrin (<=7.24 mcg/g) up to Week 8 Among Participants With Abnormal Fecal Lactoferrin (>7.24 mcg/g) at Baseline|Number of participants with normalized fecal lactoferrin (<=7.24 mcg/g) up to Week 8 among participants with abnormal fecal lactoferrin (> 7.24 mcg/g) at baseline were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing fecal lactoferrin value at the designated analysis timepoint were considered not to have normalized fecal lactoferrin.|Up to Week 8|PEAS consisted of all participants randomized in the induction study, with those participants who had abnormal fecal lactoferrin at baseline.|||Participants|||Count of Participants
2614842|NCT02006758|Secondary|Assessment of Peri-procedural Adverse Events up Until 30 Days Post Procedure||30 days||||Participants|||Count of Participants
2580265|NCT02407704|Secondary|Cardiovascular Fitness (Submaximal VO2)|Cardiorespiratory fitness was measured via submaximal VO2 on a motorized treadmill while measuring oxygen utilization via Parvo Medics True one metabolic cart. The submaximal test followed a modified Balke protocol in which speed remained constant with the intensity being increased every two minutes via a raise of 2.0% of the incline. The speed was an agreed upon speed between participant and staff (between 2.0 and 4.0 mph). The submaximal VO2 was stopped when participant reached 85% of age predicted maximal heart rate (220 - age), rating of perceived exertion (RPE) equal to or greater than 15 for those who have blunted heart rate response due to beta block medication, or volitional termination by participant. Vital signs were monitored throughout the test and cool down period. Peak VO2 values for this cohort ranged from 14.04 to 36.48 ml/kg/min, with higher values correlated to higher fitness level.|Baseline and 12 weeks|"1 participant in the Venlafaxine XR Only (20-39 Years of Age) group was excluded from analyses as he/she was non-compliant with the medication regimen, discontinuing the medication at Week 8."|||ml/kg/min||Standard Deviation|Mean
2580266|NCT02407704|Secondary|Physical Activity (SenseWear Physical Activity-monitoring Armband)|This will be used to acquire objective information about physical activity. This armband is worn around the upper arm (left triceps) for 1 week and collects information about skin temperature, galvanic skin response, heat flux, and motion via a 3-axis accelerometer. This information is used in an algorithm to determine energy expenditure (EE). The device has a resolution of 1-minute indicating that we can acquire the above information on a minute-by-minute basis, which will allow us to determine both duration and intensity of activity during a normal week. Higher values indicate higher levels of activity.|Baseline and 12 weeks|1 participant in the Venlafaxine XR Only (20-39 Years of Age) group was excluded from analyses as he/she was non-compliant with the medication regimen, discontinuing the medication after Week 8.|||kcals||Standard Deviation|Mean
2580267|NCT02407704|Secondary|Genetic Biomarkers|Blood samples were collected to assess biomarkers, but funding is not yet available to perform analyses.|Baseline and 12 weeks|Blood samples were collected to assess biomarkers, but funding is not yet available to perform analyses.|||Participants|||Count of Participants
2580268|NCT02407704|Secondary|Inflammatory Biomarkers|Blood samples were collected to assess biomarkers, but funding is not yet available to perform analyses.|Baseline and 12 weeks||||Participants|||Count of Participants
2580269|NCT02407704|Primary|Number of Participants Experiencing Remission|Study completers will be classified as remitters vs. non-remitters. Remission will be defined as a MADRS score of 10 or less for at least two consecutive assessments. The MADRS will also be used to assess clinical response throughout the trial and to determine final medication dosage. At the end of week 6, those with a MADRS score greater than 10 will have the venlafaxine XR increased from 150 mg/d to a maximum of 300 mg/d.|Baseline, weekly for weeks 1 and 2, then biweekly for weeks 4-12|"1 participant in the Venlafaxine XR Only (20-39 Years of Age) group was excluded from analyses as he/she discontinued the medication after week 8."|||Participants|||Count of Participants
2580270|NCT02407249|Other Pre-specified|Number of Participants With 6-month Safety Success|6-Month safety success was defined as freedom from Serious Adverse Events 6-months after index procedure|6-months after index procedure|Treated patients for whom 6-month safety data is available|||Participants|||Count of Participants
2580271|NCT02407249|Primary|Number of Participants With 12-Month Safety Success|12-Month safety success was defined as freedom from Serious Averse Events at 12-months after index procedure|12-months after index procedure|Treated patients for whom 12-month safety data is available|||Participants|||Count of Participants
2580272|NCT02407249|Primary|Number of Participants With Acute Safety Success|Acute safety success was defined as freedom from Serious Adverse Events 7 days after initial AF ablation|7 days after initial AF ablation|Analysis population for whom data are available|||Participants|||Count of Participants
2580273|NCT02407249|Primary|Number of Participants With 12-Month Effectiveness|Effectiveness success was defined as single procedure freedom from AF recurrence at 12-months after index procedure, excluding a 3-month blanking period.|12 months after initial AF ablation|Treated patients with 12-month follow-up data|||Participants|||Count of Participants
2580274|NCT02407249|Primary|Number of Participants With Acute Success|Acute Success was defined as elimination (by ablation) of pulmonary vein triggers during the procedure|day of procedure|All treated patients|||Participants|||Count of Participants
2580275|NCT02407236|Secondary|Maintenance Study: Change From Maintenance Baseline in Fecal Calprotectin Concentration at Weeks 8, 24, and 44|Change from Maintenance baseline in fecal calprotectin concentration at Weeks 8, 24, and 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing fecal calprotectin value at the designated analysis timepoint had their last value carried forward.|Baseline, Weeks 8, 24, and 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.|||milligram per kilogram (mg/kg)||Inter-Quartile Range|Mean
2580276|NCT02407236|Secondary|Maintenance Study: Change From Maintenance Baseline in Fecal Lactoferrin Concentration at Weeks 8, 24, and 44|Change from Maintenance baseline in fecal lactoferrin concentration at Weeks 8, 24, and 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing fecal lactoferrin value at the designated analysis timepoint had their last value carried forward.|Baseline, Weeks 8, 24, and 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.|||microgram per gram (mcg/g)||Inter-Quartile Range|Median
2581533|NCT02391363|Secondary|Social Service or Resource Use at 9 Months|Number of participants who received social services or resources over the past 3 months|Baseline, 9 months|134 participants who completed baseline assessment.|||Participants|||Count of Participants
2580277|NCT02407236|Secondary|Maintenance Study: Change From Maintenance Baseline in C-reactive Protein (CRP) Concentration at Weeks 8, 24, and 44|Change from Maintenance baseline in CRP concentration at Weeks 8, 24, and 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing CRP value at the designated analysis timepoint had their last value carried forward.|Baseline, Weeks 8, 24, and 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.|||milligram per liter (mg/L)||Inter-Quartile Range|Median
2580278|NCT02407236|Secondary|Maintenance Study: Number of Participants With Mucosal Healing at Week 44|Mucosal healing included EH and HH. EH: endoscopy subscore of 0 (normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). HH: neutrophil infiltration in <5% of crypts, no crypt destruction, no erosions/ ulcerations/ granulation tissue. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC prior to Week 44/ missing endoscopy score/ missing any component of histologic healing (i.e. assessment of neutrophils in crypts, crypt destruction/ erosions/ ulcerations/ granulations) at Week 44 and had unevaluable biopsy (biopsy collected but could not assessed due to sample preparation/ technical errors) at Week 44, but who did not achieve endoscopic healing, considered not to have mucosal healing. Endoscopy subscore assessed during central review used endoscopy video.|Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants whose mucosal healing status was determined at Week 44 with evaluable biopsy.|||Participants|||Count of Participants
2580279|NCT02407236|Secondary|Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44|EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had prohibited change in concomitant UC medication/ostomy/ colectomy/ used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to AE of worsening of UC prior to Week 44 had their Week 0 value of induction study carried forward from time of event onward and who had missing individual scale score at timepoint had their last available value carried forward. Percentage of participants with various responses to the 5 dimensions were reported.|Baseline, Weeks 20, and 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.|||Percentage of participants|||Number
2580280|NCT02407236|Secondary|Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Health State Visual Analog Scale (VAS) Score at Weeks 20 and 44|The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and participants who had a missing VAS score at a timepoint had their last available value carried forward.|Baseline, Weeks 20 and 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.|||Units on a scale||Standard Deviation|Mean
2580281|NCT02407236|Secondary|Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire Index Score at Weeks 20 and 44|EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and participants who had a missing individual scale score at a timepoint had their last available value carried forward.|Baseline, Weeks 20, and 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.|||Units on a scale||Standard Deviation|Mean
2580318|NCT02407236|Secondary|Induction Study - Change From Baseline in Fecal Lactoferrin Concentration Through Week 8|Change from baseline in fecal lactoferrin concentration through Week 8 was reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing fecal lactoferrin value at the designated analysis timepoint had their last value carried forward.|Baseline through Week 8|PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.|||microgram per gram (mcg/g)||Inter-Quartile Range|Median
2580282|NCT02407236|Secondary|Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44|SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Participants who had prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to AE of worsening of UC prior to Week 44 had Week 0 value of induction study carried forward from time of event onward and participants with missing individual scale score at timepoint had last available value carried forward.|Baseline, Weeks 20, and 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.|||Units on a scale||Standard Deviation|Mean
2580283|NCT02407236|Secondary|Maintenance Study: Change From Maintenance Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Weeks 20 and 44|SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Based on scale scores, PCS (calculated from subscales physical functioning, role-physical, bodily pain, and general health) and MCS (calculated from subscales vitality, social functioning, role-emotional and mental health) scores were derived. Summary MCS and PCS score is also scaled from 0 to 100 with higher scores= better health. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC before Week 44 had Week 0 value of IS carried forward from time of event onward and participants with missing component summary score at timepoint had last available value carried forward.|Baseline, Weeks 20, and 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.|||Units on a scale||Standard Deviation|Mean
2580284|NCT02407236|Secondary|Maintenance Study: Change From Maintenance Baseline in the IBDQ Dimension Scores at Week 20 and 44|The IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy prior to Week 44 had their Week 0 value of induction study carried forward from time of event onward and participants who had missing IBDQ dimension score at a timepoint had their last available value carried forward.|Baseline, Week 20, and 44|PEAS included all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM for specified categories at specified timepoint.|||Units on a scale||Standard Deviation|Mean
2580285|NCT02407236|Secondary|Maintenance Study: Change From Maintenance Baseline in the IBDQ Score at Week 20 and 44|IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and participants who had a missing IBDQ score at a timepoint had their last value carried forward.|Baseline, Week 20, and 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.|||Units on a scale||Standard Deviation|Mean
2580286|NCT02407236|Secondary|Maintenance Study: Number of Participants Who Maintained 20-point Improvement From Induction Baseline in IBDQ up to Week 44 Among Participants With a >20-point Improvement in IBDQ at Maintenance Baseline|IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as:10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who had missing IBDQ score were considered not to have maintained improvement in IBDQ.|Up to Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants with >20-point Improvement in IBDQ at the maintenance baseline.|||Participants|||Count of Participants
2580427|NCT02406495|Secondary|Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D|Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week||||percentage of participants|||Number
2580287|NCT02407236|Secondary|Maintenance Study: Number of Participants Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline|Number of participants not receiving concomitant corticosteroids at Week 44 among participants who received concomitant corticosteroids at maintenance Baseline were reported. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 considered to be receiving concomitant corticosteroids at Week 44. Participants who had a missing value in corticosteroid use at Week 44 had their last value carried forward.|Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC with, participants who were receiving concomitant corticosteroids at maintenance baseline.|||Participants|||Count of Participants
2580288|NCT02407236|Secondary|MS: Change From Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Participants Who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline|The change from maintenance baseline in average daily prednisone-equivalent (P.Eq) corticosteroid dose through Week 44 among the participants receiving concomitant corticosteroids other than budesonide and beclomethasone dipropionate at maintenance baseline was reported. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing value in corticosteroid use at a timepoint had their last available value carried forward to that timepoint.|Baseline Through Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who were receiving concomitant corticosteroids at maintenance baseline.|||milligram per day (mg/day)||Standard Deviation|Mean
2580289|NCT02407236|Secondary|Maintenance Study: Number of Participants With Clinical Remission at Week 44 and Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline (Per US Definition)|US definition of clinical remission: absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and Mayo endoscopy subscore of 0(normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]), without PGA. Absolute stool number is average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy findings subscores rated as 0 (normal) to 3 (severe). Participants with prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who were missing all 3 of Mayo components related to this OM (absolute stool number, rectal bleeding, and endoscopy subscore) at Week 44 were considered not in clinical remission. Participants with missing value in corticosteroid use had last value carried forward. Endoscopy subscore assessed during central review of video of endoscopy was used.|Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who were receiving concomitant corticosteroids at maintenance baseline.|||Participants|||Count of Participants
2580290|NCT02407236|Secondary|Maintenance Study: Number of Participants With Clinical Remission at Week 44 and Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline (Per Global Definition)|Global definition of clinical remission: Mayo score <=2 points, with no individual subscore >1. Mayo score includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated 0(normal) to 3(severe). Total score=sum of 4 subscores, range: 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. Participants with prohibited change in UC medication/ostomy/colectomy/used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/AE of worsening of UC before Week 44 considered not to achieved OM of clinical remission and not receiving concomitant corticosteroids (corticosteroid-free clinical remission). Participants with all 4 Mayo subscores missing at Week 44 considered not in clinical remission. Participants missing value in corticosteroid use had their last value carried forward. Endoscopy subscore assessed during central review of video of endoscopy was used.|Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC with, participants who were receiving concomitant corticosteroids at maintenance baseline.|||Participants|||Count of Participants
2580291|NCT02407236|Secondary|Maintenance Study: Number of Participants With Normal or Inactive Mucosal Disease at Week 44|Normal or inactive mucosal disease is defined as an endoscopy score of 0. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who had a missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.|||Participants|||Count of Participants
2580292|NCT02407236|Secondary|Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 Among Participants Who Had Achieved Endoscopic Healing at Maintenance Baseline|Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who had a missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who had achieved endoscopic healing at maintenance baseline.|||Participants|||Count of Participants
2580293|NCT02407236|Secondary|Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 by Biologic Failure Status|Number of participants with endoscopic healing at week 44 by BF status were reported. Endoscopic healing is improvement in endoscopic appearance of mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). BF: participants received treatment with 1 or more tumor necrosis factor (TNF) antagonists or vedolizumab at dose approved for treatment of UC, and either did not respond initially, responded initially but then lost response, or were intolerant of medication. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy, or used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to AE of worsening of UC prior to Week 44 or who had missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.|||Participants|||Count of Participants
2580294|NCT02407236|Secondary|Maintenance Study: Number of Participants With Clinical Response up to Week 44 by Biologic Failure Status|Clinical response: decrease from IS baseline in Mayo score by >=30% and >=3 points, with either decrease from baseline in RB subscore >=1/ RB subscore of 0/ 1. Mayo score have 4 subscores (SF, RB, endoscopy findings, PGA), rated 0(normal) to 3(severe). Total score=sum of 4 subscores and range from 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. BF: participants received treatment: 1/ more TNF antagonists/ vedolizumab for treating UC, no respond initially/responded initially but lost response/ medication intolerant. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/ AE of worsen UC before Week 44, had all 4 Mayo subscores miss at Week44/ lost clinical response at any time before Week44 were not in clinical response upto Week44. Endoscopy subscore assessed during central review used endoscopy video.|Up to Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.|||Participants|||Count of Participants
2580295|NCT02407236|Secondary|Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure Status (As Per US Definition)|US definition of clinical remission: absolute stool number <=3, Mayo rectal bleeding subscore: 0 (no blood seen), Mayo endoscopy subscore: 0(normal/ inactive disease) or 1(mild disease [erythema, decreased vascular pattern, mild friability]). Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy subscores: 0(normal) to 3(severe). BF: participants received 1/ more TNF antagonists/ vedolizumab for treatment of UC, not responded initially/ responded initially but lost response/ were intolerant of medicines. Participants with prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect /due to AE of worsening of UC before Week 44 or who were missing all 3 of Mayo components (absolute stool number, rectal bleeding and endoscopy) at Week 44 were not in clinical remission. Endoscopy subscore assessed during central review used video of endoscopy.|Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM with specified category.|||Participants|||Count of Participants
2580296|NCT02407236|Secondary|Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure Status (As Per Global Definition)|Global definition of clinical remission: Mayo score <=2 points, with no individual subscore >1. Mayo score included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score =sum of 4 subscores and range from 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. BF: participants received treatment with 1/ more TNF antagonists/ vedolizumab at dose approved for treatment of UC, and did not respond initially or responded initially but lost response/ were intolerant of medication. Participants with prohibited change in UC medication/ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who had all 4 Mayo subscores missing at Week 44 considered not in clinical remission. Endoscopy subscore assessed during central review of video of endoscopy was used.|Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM with specified category.|||Participants|||Count of Participants
2580297|NCT02407236|Secondary|Maintenance Study: Number of Participants in Symptomatic Remission at Week 44|Symptomatic remission was defined as a Mayo stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 were considered not to be in symptomatic remission from the time of the event onward. Participants who had both stool frequency and rectal bleeding subscores missing at Week 44 were considered not to be in symptomatic remission for that visit. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.|||Participants|||Count of Participants
2580428|NCT02406495|Secondary|Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D|Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week||||percentage of participants|||Number
2581534|NCT02391363|Secondary|Social Service or Resource Use at 6 Months|Number of participants who received social services or resources over the past 3 months|Baseline, 6 months|134 participants who completed baseline assessment.|||Participants|||Count of Participants
2580298|NCT02407236|Secondary|Maintenance Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 44|Number of participants in remission based on stool frequency subscore of 0 (normal number of stools), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) at Week 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who were missing all 3 of the Mayo subscores related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.|||Participants|||Count of Participants
2580299|NCT02407236|Secondary|Maintenance Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0 or 1, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 44|Number of participants in remission based on stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) at Week 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 and who were missing all 3 of the Mayo subscores related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.|||Participants|||Count of Participants
2580300|NCT02407236|Secondary|Maintenance Study - Change From Induction Baseline in Partial Mayo Score Through Week 44|The partial Mayo score, which is sum of 3 subscores of the Mayo score without the endoscopy subscore (stool frequency, rectal bleeding, and physician's global assessment subscores; rated as 0 [normal] to 3 [severe]). The partial Mayo score is calculated as the sum of the 3 subscores and values range from 0 to 9; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing partial Mayo score at a time point had their last available individual partial Mayo subscore carried forward to that time point.|Baseline through Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.|||Units on a scale||Standard Deviation|Mean
2580301|NCT02407236|Secondary|Maintenance Study - Change From Maintenance Baseline in Partial Mayo Score Through Week 44|The partial Mayo score, which is sum of 3 subscores of the Mayo score without the endoscopy subscore (stool frequency, rectal bleeding, and physician's global assessment subscores), rated as 0 (normal) to 3 (severe). The partial Mayo score is calculated as the sum of the 3 subscores and values range from 0 to 9; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing partial Mayo score at a time point had their last available individual partial Mayo subscore carried forward to that time point.|Baseline through Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.|||Units on a scale||Standard Deviation|Mean
2580302|NCT02407236|Secondary|Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44|The physician's global assessment subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Physician's global assessment scores: 0 = normal, 1 = mild disease, 2 = moderate disease, and 3 = severe disease. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and who had a missing Mayo subscores at a timepoint had the last available value for that subscore carried forward.|Up to Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.|||Participants|||Count of Participants
2580303|NCT02407236|Secondary|Maintenance Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 44|The endoscopy findings subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Endoscopy finding scores: 0 =normal/ inactive disease, 1 =mild disease (erythema, decreased vascular pattern, mild friability), 2 =moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 =severe disease (spontaneous bleeding, ulceration). Higher scores = worsening of disease. Participants who had prohibited change in concomitant UC medication/ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 had Week 0 value of induction study carried forward from time of event onward and who had missing endoscopy subscores at timepoint had last available value for that subscore carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.|||Participants|||Count of Participants
2580304|NCT02407236|Secondary|Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44|The rectal bleeding subscore of the Mayo Score is rated as 0 (normal) to 3 (severe). Rectal bleeding scores: 0 = no blood seen, 1 = streaks of blood with stool <half time, 2 = obvious blood with stool most of time, and 3 = blood alone passed. Higher scores = worsening of disease. Participants who had prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC before Week 44 had their Week 0 value of induction study carried forward from time of event onward and who had missing Mayo subscores at timepoint had last available value for that subscore carried forward.|Up to Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.|||Participants|||Count of Participants
2580305|NCT02407236|Secondary|Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44|Stool frequency subscore of Mayo score is rated as 0 (normal) to 3 (severe). Stool frequency scores: 0 =normal number of stools, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward or who had a missing Mayo subscores at a timepoint had the last available value for that subscore carried forward.|Up to Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.|||Participants|||Count of Participants
2580306|NCT02407236|Secondary|Maintenance Study - Change From Induction Baseline in Mayo Score at Week 44|The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total Mayo score is calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward or who had all 4 Mayo subscores missing at Week 44 had their last available individual Mayo subscores carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Induction Baseline and Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.|||Units on a scale||Standard Deviation|Mean
2580307|NCT02407236|Secondary|Maintenance Study - Change From Maintenance Baseline in Mayo Score at Week 44|The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy , or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to Week 44 had their Week 0 value of the induction study carried forward or who had all 4 Mayo subscores missing at Week 44 had their last available individual Mayo subscores carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Baseline and Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.|||Units on a scale||Standard Deviation|Mean
2580308|NCT02407236|Secondary|Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8|EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing score at a designated analysis timepoint had their last value carried forward. Percentage of participants with various responses to the 5 dimensions were reported.|Baseline and Week 8|PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified category.|||Percentage of Participants|||Number
2580309|NCT02407236|Secondary|Induction Study - Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Health State Visual Analog Scale (VAS) Score at Week 8|The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant. Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing score at a designated analysis timepoint had their last value carried forward.|Baseline and Week 8|PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants analyzed for this OM.|||Units on a scale||Standard Deviation|Mean
2580319|NCT02407236|Secondary|Induction Study - Number of Participants With Normalized CRP (<=3 mg/L) up to Week 8 Among Participants With Abnormal CRP (>3 mg/L) at Baseline|Number of participants with normalized CRP (<=3 mg/L) up to Week 8 among participants with abnormal CRP (>3 mg/L) at baseline were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing CRP value at the designated analysis timepoint were considered not to have normalized CRP.|Up to Week 8|PEAS consisted of all participants randomized in the induction study, with those participants who were having abnormal CRP at baseline.|||Participants|||Count of Participants
2580310|NCT02407236|Secondary|Induction Study - Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire Index Score at Week 8|EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing score at a designated analysis timepoint had their last value carried forward.|Baseline and Week 8|PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants analyzed for this OM.|||Units on a scale||Standard Deviation|Mean
2580311|NCT02407236|Secondary|Induction Study - Change From Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Week 8|SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing individual scale at a designated analysis timepoint had their last value carried forward.|Baseline and Week 8|PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.|||Units on a scale||Standard Deviation|Mean
2580312|NCT02407236|Secondary|Induction Study - Change From Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Week 8|SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Based on scale scores, physical component summary (PCS: calculated from subscales physical functioning, role-physical, bodily pain, and general health) and mental component summary (MCS: calculated from subscales vitality, social functioning, role-emotional and mental health) scores were derived. Summary MCS and PCS score is also scaled from 0 to 100 with higher scores= better health. Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing component summary score at Week 8 had their last value carried forward.|Baseline and Week 8|PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.|||Units on a scale||Standard Deviation|Mean
2580313|NCT02407236|Secondary|Induction Study - Change From Baseline in IBDQ Dimension Scores at Week 8|The IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward and participants who had missing IBDQ dimension score at designated analysis timepoint had their last value carried forward.|Baseline and Week 8|PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified category.|||Units on a scale||Standard Deviation|Mean
2580314|NCT02407236|Secondary|Induction Study - Number of Participants With a >20-point Improvement From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8|The IBDQ is 32-item questionnaire for participants with Inflammatory Bowel Disease (IBD) used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing IBDQ score at either baseline or Week 8 were considered not to have achieved a greater than 20-point improvement.|Baseline and Week 8|PEAS consisted of all participants randomized in the induction study.|||Participants|||Count of Participants
2580315|NCT02407236|Secondary|Induction Study - Number of Participants With Normalized Fecal Calprotectin (<=250 mg/kg) up to Week 8 Among Participants With Abnormal Fecal Calprotectin (>250 mg/kg) at Baseline|Number of participants with normalized fecal calprotectin (<=250 milligram per kilogram [mg/kg) up to Week 8 among participants with abnormal fecal calprotectin (>250 mg/kg) at baseline were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing fecal calprotectin value at the designated analysis timepoint were considered not to have normalized fecal calprotectin.|Up to Week 8|PEAS consisted of all randomized participants in the induction study, with abnormal fecal calprotectin (>250 mg/kg) at baseline.|||Participants|||Count of Participants
2580316|NCT02407236|Secondary|Induction Study - Change From Baseline in Fecal Calprotectin Concentration Through Week 8|Change from baseline in fecal calprotectin concentration through Week 8 was reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing fecal calprotectin value at the designated analysis timepoint had their last value carried forward.|Baseline through Week 8|PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.|||milligram per kilogram (mg/kg)||Inter-Quartile Range|Median
2587275|NCT02320838|Primary|Mechanical Pain Threshold During Treatment|The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton|during treatment at 15 min||||N||Standard Deviation|Mean
2580320|NCT02407236|Secondary|Induction Study - Change From Baseline in C-reactive Protein (CRP) Concentration Through Week 8|Change from baseline in CRP concentration through Week 8 was reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing CRP value at the designated analysis timepoint had their last value carried forward.|Baseline through Week 8|PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.|||milligram per liter (mg/L)||Inter-Quartile Range|Median
2580321|NCT02407236|Secondary|Induction Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)|Number of participants in remission based on stool frequency subscore of 0 (normal number of stools), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) at Week 8 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 8|PEAS consisted of all participants randomized in the induction study.|||Participants|||Count of Participants
2580322|NCT02407236|Secondary|Induction Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0 or 1, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)|Number of participants in remission based on stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) at Week 8 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 8|PEAS consisted of all participants randomized in the induction study.|||Participants|||Count of Participants
2580323|NCT02407236|Secondary|Induction Study - Number of Participants With Clinical Response at Week 8 by Biologic Failure Status|Clinical response: decrease from induction baseline in Mayo score by >=30% and >= 3 points, with either decrease from baseline in rectal bleeding subscore >=1/ rectal bleeding subscore= 0/1. Mayo score included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score =sum of 4 subscores and range from 0 to 12, where 3 to 5 = mild; 6 to 10 = moderate; 11 to 12 = severe; higher scores =worsening of disease. BF: participants received treatment with 1/ more TNF antagonists and/or vedolizumab at dose approved for treatment of UC, and did not respond initially or responded initially but lost response/ were intolerant of medication. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not in clinical response. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 8|PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.|||Participants|||Count of Participants
2580324|NCT02407236|Secondary|Induction Study - Number of Participants With Endoscopic Healing at Week 8 by Biologic Failure Status|Number of participants with endoscopic healing at week 8 by BF status were reported. Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). BF: Participants received treatment with 1/ more TNF antagonists and/or vedolizumab at dose approved for treatment of UC, and either did not respond initially, responded initially but then lost response/ were intolerant of medication. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had a missing endoscopy score at Week 8 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 8|PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.|||Participants|||Count of Participants
2580325|NCT02407236|Secondary|Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per US Definition)|US definition of clinical remission: absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), Mayo endoscopy subscore of (normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]), without PGA. Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy subscores rated 0 (normal) to 3 (severe). BF: participants received treatment with 1/ more TNF antagonists/ vedolizumab at dose approved for treatment of UC, and did not respond initially or responded initially but lost response/ intolerant of medication. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8/ missing all 3 of Mayo components (absolute stool number, rectal bleeding, Mayo endoscopy subscore) at Week 8 considered not in clinical remission. Endoscopy subscore assessed during central review used endoscopy video.|Week 8|PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.|||Participants|||Count of Participants
2580333|NCT02407236|Secondary|Induction Study - Number of Participants in With Normal or Inactive Mucosal Disease at Week 8|Normal or inactive mucosal disease is defined as an endoscopy score of 0. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had a missing endoscopy score at Week 8 were considered not to have normal or inactive mucosal disease. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 8|PEAS consisted of all participants randomized in the induction study.|||Participants|||Count of Participants
2580429|NCT02406495|Secondary|Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D|Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week||||percentage of participants|||Number
2580326|NCT02407236|Secondary|Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per Global Definition)|Global definition of clinical remission: Mayo score<=2 points, with no individual subscore >1. Mayo score included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score = sum of 4 subscores and range from 0 to 12, where 3 to 5 = mild; 6 to 10 = moderate; 11 to 12 = severe; higher scores indicate worsening of disease. BF: participants received treatment with 1 or more tumor necrosis factor (TNF) antagonists and/or vedolizumab at dose approved for treatment of UC and did not respond initially or responded initially but lost response or were intolerant of medication. Participants with prohibited change in concomitant UC medication/ ostomy/colectomy before Week 8 or who had all 4 Mayo subscores missing at Week 8 considered not in clinical remission. Endoscopy subscore assessed during central review of video of endoscopy was used.|Week 8|The primary efficacy analysis set consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.|||Participants|||Count of Participants
2580327|NCT02407236|Secondary|Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8|The physician's global assessment subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Physician's global assessment scores: 0 = normal, 1 = mild disease, 2 = moderate disease, and 3 = severe disease. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo physician's global assessment subscore at the designated analysis timepoint had the last available value for that subscore carried forward.|Up to Week 8|PEAS consisted of all participants randomized in the induction study.|||Participants|||Count of Participants
2580328|NCT02407236|Secondary|Induction Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 8|The endoscopy findings subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Endoscopy finding scores: 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern, mild friability), 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 = Severe disease (spontaneous bleeding, ulceration). Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo endoscopy subscore at Week 8 had the last available value for that subscore carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 8|PEAS consisted of all participants randomized in the induction study.|||Participants|||Count of Participants
2580329|NCT02407236|Secondary|Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8|The rectal bleeding subscore of the Mayo Score is rated as 0 (normal) to 3 (severe). Rectal bleeding scores: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, and 3 = blood alone passed. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo rectal bleeding subscore at the designated analysis timepoint had the last available value for that subscore carried forward.|Up to Week 8|PEAS consisted of all participants randomized in the induction study.|||Participants|||Count of Participants
2580330|NCT02407236|Secondary|Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8|The stool frequency subscore of Mayo score is rated as 0 (normal) to 3 (severe). Stool frequency scores: 0 =normal number of stools, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo stool frequency subscore at the designated analysis timepoint had the last available value for that subscore carried forward.|Up to Week 8|PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this OM.|||Participants|||Count of Participants
2580331|NCT02407236|Secondary|Induction Study - Change From Baseline in Partial Mayo Score Through Week 8|The partial Mayo score, which is sum of 3 subscores of the Mayo score without the endoscopy subscore (stool frequency, rectal bleeding, and physician's global assessment subscores; rated as 0 [normal] to 3 [severe]). The partial Mayo score is calculated as the sum of the 3 subscores and values range from 0 to 9; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants with the partial Mayo score missing at a timepoint had their last available individual partial Mayo subscore carried forward to that timepoint.|Baseline through Week 8|PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2580332|NCT02407236|Secondary|Induction Study - Change From Baseline in Mayo Score at Week 8|The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline Mayo score carried forward to Week 8 or who had all 4 Mayo subscores missing at Week 8 had their last available individual Mayo subscores carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Baseline and Week 8|PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this OM.|||Units on a scale||Standard Deviation|Mean
2580430|NCT02406495|Secondary|Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D.|1 Week||||percentage of participants|||Number
2580334|NCT02407236|Secondary|Induction Study - Number of Participants in Symptomatic Remission at Week 8|Symptomatic remission was defined as a Mayo stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 and/or both stool frequency and rectal bleeding subscores missing at Week 8 were considered not to be in symptomatic remission.|Week 8|PEAS consisted of all participants randomized in the induction study.|||Participants|||Count of Participants
2580335|NCT02407236|Secondary|Induction Study - Number of Participants in Clinical Remission With a Rectal Bleeding Subscore of 0 at Week 8 (As Per Global Definition)|As per global definition, clinical remission is defined as Mayo score <=2 points, with no individual subscore >1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had missing rectal bleeding subscores at Week 8 were considered not to be in clinical remission with a rectal bleeding subscore of 0. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 8|PEAS consisted of all participants randomized in the induction study.|||Participants|||Count of Participants
2580336|NCT02407236|Secondary|Induction Study - Number of Participants With Mucosal Healing at Week 8|Mucosal healing is defined as having both endoscopic healing (EH) and histologic healing (HH). Endoscopic healing: an endoscopy subscore of 0 (normal or inactive disease) or 1 mild disease ([erythema, decreased vascular pattern, mild friability]). Histologic healing: neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions or ulcerations or granulation tissue. Participants who had prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8 or had missing endoscopy score/ were missing any component of histologic healing (that is assessment of neutrophils in crypts, crypt destruction/ erosions/ ulcerations/ granulations) at Week 8 or who had unevaluable biopsy (that is biopsy collected, but could not be assessed due to sample preparation or technical errors) at Week 8 but who did not achieve endoscopic healing, were considered not to have mucosal healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 8|PEAS consisted of all participants randomized in the induction study, with participants whose mucosal healing status was determined at Week 8.|||Participants|||Count of Participants
2580337|NCT02407236|Secondary|Maintenance Study: Number of Participants With Clinical Remission up to Week 44 Among Participants Who Achieved Clinical Remission at Maintenance Study Baseline (As Per US Definition)|US definition of clinical remission: absolute stool number <=3, Mayo rectal bleeding subscore of 0 (no blood seen), Mayo endoscopy subscore of 0 (normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy subscores: 0 (normal) to 3 (severe). Participants with prohibited change in UC medication/ostomy/colectomy/used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/ AE of worsening of UC before Week 44/ missing all 3 of Mayo components (absolute stool number, rectal bleeding, and Mayo endoscopy subscore) at Week 44 were considered not in clinical remission. Participants not in clinical remission at any time point when endoscopic scores collected before Week 44 considered not in clinical remission up to Week 44. Endoscopy subscore assessed during central review of video of endoscopy was used.|Up to Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who were in clinical remission at maintenance baseline.|||Participants|||Count of Participants
2580338|NCT02407236|Secondary|Maintenance Study: Number of Participants With Clinical Remission up to Week 44 Among Participants Who Achieved Clinical Remission at Maintenance Study Baseline (As Per Global Definition)|Global definition of clinical remission: Mayo score <=2 points, with no individual subscore >1. Mayo score includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score: sum of 4 subscores and range from 0 to 12, where 3 to 5= mild; 6 to 10= moderate; and 11 to 12= severe; higher scores indicate worsening of disease. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical remission. Participants who were not in clinical remission at any time points when endoscopic scores were collected before Week 44 were considered not to be in clinical remission up to Week 44. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Up to Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who were in clinical remission at maintenance baseline.|||Participants|||Count of Participants
2580339|NCT02407236|Secondary|Maintenance Study: Number of Participants With Clinical Remission and Not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As Per US Definition)|US definition of clinical remission: absolute stool number <=3, rectal bleeding subscore 0 (no blood seen), Mayo endoscopy subscore of 0(normal or inactive disease)/ 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy findings subscores rated: 0 (normal) to 3 (severe). Participants with prohibited change in UC medication/ostomy/colectomy/used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or were missing all 3 of Mayo components related to this OM (absolute stool number, rectal bleeding, and Mayo endoscopy subscore) at Week 44 were considered not in corticosteroid-free clinical remission at Week 44. Participants with missing value in corticosteroid use at Week 44 had last value carried forward. Endoscopy subscore assessed during central review of video of endoscopy was used.|Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.|||Participants|||Count of Participants
2587435|NCT02318940|Secondary|Number of Attempts|Number of participants who succeeded in the installation of cvc in one, two, three, four or five attempts.|intraoperative, an average of 1 hour||||participants|||Number
2580340|NCT02407236|Secondary|Maintenance Study: Number of Participants With Clinical Remission and Not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As Per Global Definition)|Per global definition, clinical remission was defined as Mayo score <=2 points, with no individual subscore >1. Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score: sum of 4 subscores and range from 0 to 12, where 3 to 5= mild; 6 to 10= moderate; and 11 to 12= severe; higher scores indicate worsening of disease. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or had all 4 Mayo subscores missing at Week 44 were considered not to have achieved OM of clinical remission and not receiving corticosteroids at Week 44. Participants who had missing value in corticosteroid use at Week 44 had their last value carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 44|PEAS included all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w/ placebo SC.|||Participants|||Count of Participants
2580341|NCT02407236|Secondary|Maintenance Study: Number of Participants With Endoscopic Healing at Week 44|Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It was defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Participants who had prohibited change in UC medication, an ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC prior to Week 44 or who had missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.|||Participants|||Count of Participants
2580342|NCT02407236|Secondary|Maintenance Study: Number of Participants With Clinical Response up to Week 44|Clinical response: decrease from induction baseline in Mayo score by >= 30% and >= 3 points, with either decrease from induction baseline in rectal bleeding subscore >=1 or rectal bleeding subscore of 0 or 1. Mayo score includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5= mild; 6 to 10= moderate; 11 to 12= severe; higher scores indicate worsening of disease. Participants who lost clinical response at any time before Week 44, had prohibited change in UC medication, ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical response. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Up to Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.|||Participants|||Count of Participants
2580343|NCT02407236|Secondary|Induction Study - Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8|The IBDQ is 32-item questionnaire for participants with Inflammatory Bowel Disease (IBD) used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of event onward or participants who had missing IBDQ score at Week 8 had their last value carried forward.|Baseline and Week 8|PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this outcome measure (OM).|||Units on a scale||Standard Deviation|Mean
2580344|NCT02407236|Secondary|Induction Study: Number of Participants With Clinical Response at Week 8|Clinical response was defined as a decrease from induction baseline in the Mayo score by >=30 percent (%) and >= 3 points, with either a decrease from baseline in the rectal bleeding subscore >=1 or a rectal bleeding subscore of 0 or 1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not to be in clinical response. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 8|PEAS consisted of all participants randomized in the induction study.|||Participants|||Count of Participants
2580345|NCT02407236|Secondary|Induction Study: Number of Participants With Endoscopic Healing at Week 8|Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing endoscopy score at Week 8 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 8|PEAS consisted of all participants randomized in the induction study.|||Participants|||Count of Participants
2580400|NCT02406586|Secondary|Change in Pulse Wave Velocity (PWV)|PWV was measured between the carotid and femoral arteries using the SphygmoCor device. Pressure waveforms at the carotid and femoral arteries were acquired using EKG gating. Velocity (distance per time in milliseconds) was calculated using the foot-to-foot method and the distance between the sites was measured manually.|Baseline, 6 weeks|not assessed (limited funds available)||||||
2581535|NCT02391363|Secondary|Hospital Admissions at 9 Months|Number of participants who were admitted to a hospital in the past 3 months.|Baseline, 9 months|134 participants who completed baseline assessment.|||Participants|||Count of Participants
2580346|NCT02407236|Primary|Maintenance Study: Number of Participants With Clinical Remission at Week 44 (as Per US Definition)|Per US definition, clinical remission: absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and a Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]), without the physician's global assessment. Absolute stool number is average of daily stool number over the three days. The Mayo rectal bleeding and endoscopy findings subscores were rated as 0 (normal) to 3 (severe). Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC prior to Week 44 and who were missing all 3 of Mayo components pertaining to this OM (absolute stool number, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.|||Participants|||Count of Participants
2580347|NCT02407236|Primary|Maintenance Study: Number of Participants With Clinical Remission at Week 44 (As Per Global Definition)|As per global definition, clinical remission was defined as a Mayo score <=2 points, with no individual subscore >1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in UC medication or an ostomy or colectomy or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of the video of the endoscopy was used.|Week 44|PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC every 8 weeks (q8w), ustekinumab 90 mg SC every 12 weeks (q12w), or placebo SC.|||Participants|||Count of Participants
2580348|NCT02407236|Primary|Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per US Definition)|As per US definition, clinical remission was defined as absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and a Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) without the physician's global assessment. Absolute stool number is average of daily stool number over the three days. The Mayo rectal bleeding and endoscopy findings subscores were rated as 0 (normal) to 3 (severe). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components pertaining to this outcome measure (OM) (absolute stool number, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of the video of the endoscopy was used.|Week 8|PEAS consisted of all participants randomized in the induction study.|||Participants|||Count of Participants
2580349|NCT02407236|Primary|Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per Global Definition)|As per global definition, clinical remission is defined as a Mayo score less than or equal to (<=)2 points, with no individual subscore greater than (>)1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding [RB], endoscopy findings, and physician's global assessment [PGA]), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant ulcerative colitis (UC) medication or an ostomy or colectomy prior to the Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.|Week 8|The primary efficacy analysis set (PEAS) consisted of all participants randomized in the induction study.|||Participants|||Count of Participants
2580350|NCT02407223|Secondary|Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16, and 20|ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included total back pain(TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment(PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*total back pain)+ (0.110*PGA)+ (0.073*peripheral pain/swelling)+ (0.058* DMS)+ (0.579*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Inactive disease is defined as an ASDAS score <1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI (missing responses at post baseline visit imputed as non-responder).|Week 4, 8, 12, 16, and 20|MFAS- participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.|||Percentage of participants|||Number
2580351|NCT02407223|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 4, 8, 12, 16 and 20|The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Missing data were imputed using early escape rule (measurement value at Week 20 and 24 was set as missing). Here 'n' defined as number of participants who were analyzed at each specified timepoint, for each arm, respectively.|Baseline, Week 4, 8, 12, 16 and 20|MFAS-participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.|||Units on a scale||Standard Deviation|Mean
2580352|NCT02407223|Secondary|Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20|The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe. In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness will be added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-10) is the average of the overall total score. Higher BASDAI score indicates more severe AS symptom. 50% improvement in BASDAI based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responders).|Week 4, 8, 12, 16, and 20|MFAS- participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.|||Percentage of participants|||Number
2580353|NCT02407223|Secondary|Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20|ASAS 20 defined as improvement of >= 20 % from baseline and absolute improvement from baseline of 1 on a 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor), total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 to participant's ability to cope with everyday life), Inflammation (0 to 10 cm;0=none,10=very severe); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in remaining domain. ASAS20 response based on imputed data using treatment failure (consider non-responders at and after treatment failure),early escape rules (consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).|Week 4, 8, 12, 16 and 20|MFAS- participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.|||Percentage of participants|||Number
2580354|NCT02407223|Secondary|Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20|ASAS 40 defined as improvement of >= 40% from baseline and absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure (consider non-responders at and after treatment failure), early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).|Week 4, 8, 12, 16 and 20|MFAS- participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.|||Percentage of participants|||Number
2580355|NCT02407223|Secondary|Percentage of Participants With ASAS 20 Components at Week 24|ASAS 20 defined as >= 20% improvement from baseline in 4 individual components of ASAS20: Patient's global assessment (PGA) of disease activity (0 to 10cm; 0=very well,10=very poor), total back pain(0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean(0 to10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to functional anatomy and 2 relate to participant's ability to cope with life) and Inflammation (0 to 10cm;0=none,10=very severe).|Week 24|MFAS- participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received. 'N' signifies number of participants who were evaluable for this endpoint.|||Percentage of participants|||Number
2580356|NCT02407223|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24|Change from baseline in hsCRP levels was reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing). Here 'n' signifies the number of participants who were analyzed at each specified timepoints, for each arm, respectively.|Baseline, Week 4, 8, 12, 16, 20 and 24|MFAS-participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.|||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2580357|NCT02407223|Secondary|Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-reactive Protein (CRP) Inactive Disease (<1.3) at Week 24|ASDAS includes CRP milligram per liter (mg/L); four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included total back pain(TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment(PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*total back pain)+ (0.110*PGA)+ (0.073*peripheral pain/swelling)+ (0.058* DMS)+ (0.579*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Inactive disease is defined as an ASDAS score <1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI (missing responses at post baseline visit imputed as non-responder).|Week 24|MFAS- participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.|||Percentage of participants|||Number
2580433|NCT02406495|Secondary|Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness).|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
2580358|NCT02407223|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24|The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of ankylosing spondylitis participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).|Baseline, Week 24|MFAS population was included. Participants were analyzed per assigned treatment regardless of actual treatment received. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this endpoint.|||Units on a scale||Standard Deviation|Mean
2580359|NCT02407223|Secondary|Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24|The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe. In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness were added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-10) is the average of the overall total score. Higher BASDAI score indicates more severe AS symptom. 50% improvement in response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).|Week 24|MFAS- participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.|||Percentage of participants|||Number
2580360|NCT02407223|Secondary|Percentage of Participants Who Achieved an ASAS 40 Response at Week 24|ASAS 40 defined as improvement of >= 40% from baseline and absolute improvement from baseline of at least 2 on 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor),total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10 cm; 0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).|Week 24|MFAS- participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.|||Percentage of participants|||Number
2580361|NCT02407223|Primary|Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24|ASAS 20 defined as improvement of greater than or equal to (>=) 20 % from baseline and absolute improvement from baseline of 1 on a 0 to 10 centimeter(cm) scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor), total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 to participant's ability to cope with everyday life), Inflammation (0 to 10 cm;0=none,10=very severe); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in remaining domain. ASAS20 response based on imputed data using treatment failure (consider non-responders at and after treatment failure),early escape rules (consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).|Week 24|Modified Full Analysis Set (MFAS)-participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.|||Percentage of participants|||Number
2580362|NCT02407132|Secondary|Change in Mean Triglycerides From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention|Informally and in response to a survey item, many participants reported that they had not adhered to instructions to fast before data collection. For this reason, we were unable to collect valid measures for fasting glucose, low-density lipoproteins (LDL), and triglycerides.|Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-Intervention|||||||
2580363|NCT02407132|Secondary|Change in Mean Low-density Lipoproteins (LDL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention|Informally and in response to a survey item, many participants reported that they had not adhered to instructions to fast before data collection. For this reason, we were unable to collect valid measures for fasting glucose, low-density lipoproteins (LDL), and triglycerides.|Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-Intervention|||||||
2580364|NCT02407132|Secondary|Change in Mean Fasting Glucose From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention|Informally and in response to a survey item, many participants reported that they had not adhered to instructions to fast before data collection. For this reason, we were unable to collect valid measures for fasting glucose, low-density lipoproteins (LDL), and triglycerides.|Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-Intervention|||||||
2580401|NCT02406586|Secondary|Change in FFA (Free Fatty Acid) Levels From Baseline to 6 Weeks|Blood samples were collected for measurement of free fatty acids at baseline and 6 weeks after the Intralipid 20% infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change is the difference between 6-week FFA levels from baseline FFA levels.|Baseline, 6 weeks||||mmol/L||Standard Deviation|Mean
2580365|NCT02407132|Secondary|Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Engage in Recommended Level of Physical Activity|This measure assesses whether or not each participant reported engaging in 60 minutes or more of vigorous activity per week or 150 minutes or more of moderate activity per week at baseline and 12 months post-intervention. This measure was lightly adapted from the measure of physical activity used here: L. Jiang, S. Chen, B. Zhang, J. Beals, C.M. Mitchell, S.M. Manson, et al. Longitudinal patterns of stages of change for exercise and lifestyle intervention outcomes: an application of latent class analysis with distal outcomes. Prev. Sci., 17 (2016), pp. 398-409. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)|Baseline, 12 Months Post-Intervention||||Probability||95% Confidence Interval|Mean
2580366|NCT02407132|Secondary|Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Maintain a Normal Weight|This measure assesses whether or not each participant had a normal weight at baseline and 12 months post-intervention as indicated by body mass index (i.e., body mass index between 18.5 to 24.9). Participant weight (without shoes) was measured in light clothing to the nearest 0.5 lb (0.2 kg) using a calibrated digital scale. Height (without shoes) was measured to the nearest 0.5 cm using a stadiometer. Weight and height were used to compute a continuous measure of BMI (kg/m²). (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)|Baseline, 12 Months Post-Intervention||||Probability||95% Confidence Interval|Mean
2580367|NCT02407132|Secondary|Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Eye Exam in Past 12 Months|This measure assesses whether or not each participant reported having an eye exam in which the pupils were dilated in the past 12 months at baseline and 12 months post-intervention. This measure of participant-reported current level of diabetes self-care was assessed through an item from the Behavioral Risk Factor Surveillance System (BRFSS) Diabetes Module. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)|Baseline, 12 Months Post-Intervention||||Probability||95% Confidence Interval|Mean
2580368|NCT02407132|Secondary|Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Foot Exam by Doctor or Other Health Professional in Past 12 Months|This measure assesses whether or not each participant reported having a health professional check her/his feet for any sores or irritations in the past 12 months at baseline and 12 months post-intervention. This measure of participant-reported current level of diabetes self-care was assessed through an item from the Behavioral Risk Factor Surveillance System (BRFSS) Diabetes Module. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)|Baseline, 12 Months Post-Intervention||||Probability||95% Confidence Interval|Mean
2580369|NCT02407132|Secondary|Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Seen Doctor or Other Health Professional in Past 12 Months for Diabetes|This measure assesses whether or not each participant reported seeing a doctor, nurse, or other health professional for her/his diabetes within the past 12 months at baseline and 12 months post-intervention. This measure of participant-reported current level of diabetes self-care was assessed through an item from the Behavioral Risk Factor Surveillance System (BRFSS) Diabetes Module. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)|Baseline, 12 months post-intervention||||Probability||95% Confidence Interval|Mean
2580370|NCT02407132|Secondary|Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Check Blood Glucose Daily|This measure assesses whether or not each participant reported checking her/his blood glucose at least daily at baseline and 12 months post-intervention. This measure of participant-reported current level of diabetes self-care was assessed through an item from the Behavioral Risk Factor Surveillance System (BRFSS) Diabetes Module. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)|Baseline, 12 months post-intervention||||Probability||95% Confidence Interval|Mean
2580371|NCT02407132|Secondary|Change in Mean High-density Lipoproteins (HDL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.|A commercial lipid panel kit and Cholestech LDX analyzer were used to assess HDL levels. The outcome measure was change in mean HDL from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. Analyses were adjusted for baseline sex, age, education, marital status, employment status, use of diabetes medication, and households containing multiple participants.|Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention||||HDL (mg/dL)||95% Confidence Interval|Mean
2580372|NCT02407132|Secondary|Change in Mean Total Cholesterol (mg/dL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.|Through finger prick blood collection, point of care tests were used to test fasting lipids using a commercial lipid panel kit and Cholestech LDX analyzer. Analyses were adjusted for baseline sex, age, education, marital status, employment status, use of diabetes medication, and households containing multiple participants.|Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention||||Total Cholesterol (mg/dL)||95% Confidence Interval|Mean
2580373|NCT02407132|Secondary|Change in Mean BMI From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention|Participant weight (without shoes) was measured in light clothing to the nearest 0.5 lb (0.2 kg) using a calibrated digital scale. Height (without shoes) was measured to the nearest 0.5 cm using a stadiometer. Weight and height were used to compute a continuous measure of BMI (kg/m²).|Baseline, Immediate post-intervention; 6 months post-intervention; 12 months post-intervention||||BMI (kg/m²)||95% Confidence Interval|Mean
2580374|NCT02407132|Primary|Glycemic Control, Measured by Change in Adjusted Mean HbA1c (%) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.|A Siemens analyzer (point of care) was utilized to calculate HbA1c levels for each participant. The primary outcome measure was change in adjusted mean HbA1c (%) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. Analyses were adjusted for baseline sex, age, education, marital status, employment status, use of diabetes medication, and households containing multiple participants. The mean HbA1c values presented here have been adjusted, whereas the mean HbA1c values presented in the Baseline Data section are unadjusted.|Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention||||Percent Glycated Hemoglobin (adjusted)||95% Confidence Interval|Mean
2580375|NCT02406937|Secondary|Body Mass Index (BMI)|BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m^2 (kilogram per square meter).|Baseline, Week 4, Week 8, Week 12||||kg/m^2||Standard Deviation|Mean
2580376|NCT02406937|Secondary|Sleeping Time|Questionnaire recorded by parents. Average sleeping time per day during the measurement week.|Baseline, Week 4, Week 8, Week 12||||hours/day||Standard Deviation|Mean
2580377|NCT02406937|Secondary|Milk Feeding Quantity|Questionnaire recorded by parents. Average quantity of milk feeding per day during the measurement week.|Baseline, Week 4, Week 8, Week 12||||ml/day||Standard Deviation|Mean
2580378|NCT02406937|Secondary|Milk Regurgitation Frequency|Questionnaire recorded by parents. Average daily frequency of milk regurgitation during the measurement week.|Baseline, Week 4, Week 8, Week 12||||Times/day||Standard Deviation|Mean
2580379|NCT02406937|Secondary|Chest Circumference||Baseline, Day 28, Day 56, Day 84||||cm||Standard Deviation|Mean
2580380|NCT02406937|Secondary|Head Circumference||Baseline, Day 28, Day 56, Day 84||||cm||Standard Deviation|Mean
2580381|NCT02406937|Secondary|Body Weight||Baseline, Day 28, Day 56, Day 84||||g||Standard Deviation|Mean
2580382|NCT02406937|Secondary|Eczema Duration||Throughout the study period (84 days)||||Days||Standard Deviation|Mean
2580383|NCT02406937|Secondary|Fecal Bacterium Concentration|bifidobacterium, lactobacillus, clostridium perfringens|Baseline, Day 21||||log (colony forming units)||Standard Deviation|Mean
2580384|NCT02406937|Secondary|Fecal Laboratory Detection for sIgA||Baseline, Day 84||||ug/ml||Standard Deviation|Mean
2580385|NCT02406937|Secondary|Number of Participants With Eczema||Throughout the study period (84 days)||||participants|||Number
2580386|NCT02406937|Secondary|Body Length|Body length|Baseline, Day 28, Day 56, Day 84||||cm||Standard Deviation|Mean
2580387|NCT02406937|Secondary|Fecal Concentration of Short Chain Fatty Acid|fecal concentration of acetate, propionate and butyrate acid|Baseline, Day 21||||mg/g||Standard Deviation|Mean
2580388|NCT02406937|Secondary|Crying Time|Questionnaire recorded by parents. Average crying time per day during the measurement week.|Baseline, Week 4, Week 8, Week 12||||minutes/day||Standard Deviation|Mean
2580389|NCT02406937|Secondary|Stool Consistency|"Average Bristol Score during the measurement week. The seven types of stool are:~= Separate hard lumps, like nuts (difficult to pass)~= Sausage-shaped but lumpy~= Like a sausage but with cracks in its surface~= Like a sausage or snake, smooth and soft~= Soft blobs with clear-cut edges (passed easily)~= Fluffy pieces with ragged edges; a mushy stool~= Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools (especially the latter), as they are easy to defecate while not containing excess liquid, and 5, 6 and 7 tending towards diarrhoea."|Baseline, Week 4, Week 8, Week 12||||units on a scale||Standard Deviation|Mean
2580390|NCT02406937|Secondary|Number of Participants With Gastrointestinal Symptoms|Number of participants with symptom of bloating and abdominal pain|Weekly (Baseline to Day 84)||||participants|||Number
2580391|NCT02406937|Primary|Stool Frequency|Average daily stool frequency during the measurement week|Baseline, Week 4, Week 8, Week 12||||Times per day||Standard Deviation|Mean
2580392|NCT02406677|Secondary|P2Y12 Receptor Inhibitor Selection|To evaluate whether reducing patient copayments for both generic and brand P2Y12 receptor inhibitor options affects medication selection at discharge.|12 months|Primary Population|||Percentage of Patients|||Number
2580393|NCT02406677|Primary|Percentage of Patients With Long Term Non-persistence to P2Y12 Receptor Inhibitor|To determine if patient copayment reduction leads to higher long-term persistence of any P2Y12 receptor inhibitor at 1 year after discharge.|12 months|Primary Population|||Percentage of Patients|||Number
2580394|NCT02406677|Primary|Kaplan-Meier Cumulative Incidence Rate of Major Adverse Cardiovascular Events|To determine if patient copayment reduction leads to lower risk of MACE (composite of death, MI, and stroke) at 1 year after discharge.|12 months|Primary Population|||Percentage of Participants||95% Confidence Interval|Number
2580395|NCT02406612|Secondary|Adverse Events|The rate of adverse events within approximately 30 days following the procedure. All AEs counted, whether or not device-related.|30 days||||Participants|||Count of Participants
2580396|NCT02406612|Secondary|Time-to-Ambulation|The time from end of the procedure until the patient ambulates for the first time.|Ambulation will be assessed 1.5 hours after removal of the access sheath for Diagnostic Patients, and 3 hours after procedure sheath removal for Interventional Patients.|Subjects for whom ambulation data are available|||hours||Standard Deviation|Mean
2580397|NCT02406612|Primary|Time-to-Hemostasis|Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding.|Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding, assessed up to 2 hours.||||Minutes||Standard Deviation|Mean
2580398|NCT02406612|Primary|Major Complications|The rate of major complications within approximately 30 days following the procedure.|30 days||||Participants|||Count of Participants
2580399|NCT02406586|Secondary|Change in Expression of Inflammatory Biomarker C-Reactive Protein (CRP)|It is measured by using microsphere-based flow cytometric immunoassay. Change is the difference between 6-week inflammatory biomarker level from baseline level.|Baseline, 6 weeks||||mg/dL||Standard Deviation|Mean
2580402|NCT02406586|Secondary|Change in Expression of Inflammatory Biomarker Interleukin-6 (IL-6)|It is measured by using microsphere-based flow cytometric immunoassay. Change is the difference between 6-week level from baseline level.|Baseline, 6 weeks||||pg/ml||Standard Deviation|Mean
2580405|NCT02406586|Secondary|Change in Diastolic Blood Pressure From Baseline to 6 Weeks|Diastolic blood pressure is the amount of pressure in the arteries when the heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 6-week diastolic blood pressure from baseline diastolic blood pressure.|Baseline, 6 weeks|6 subjects were lost to follow up, 1 withdrew from the study, and data was not collected for 1 additional subject|||mmHg||Standard Deviation|Mean
2580406|NCT02406586|Primary|Change in Flow-mediated Dilation|The change in endothelium-dependent vascular reactivity will be measured by flow-mediated dilation (FMD) of the brachial artery using a high-resolution vascular ultrasound with a 10-MHz linear array transducer. FMD is expressed as the percentage increase in diameter at the Week 6 visit from pre-dosing with Intralipid to 24 hours during Intralipid infusion|Pre-dose (Week 6), within 24 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.|||percent change in diameter||Standard Deviation|Mean
2580407|NCT02406586|Primary|Change in Flow-mediated Dilation|The change in endothelium-dependent vascular reactivity will be measured by flow-mediated dilation (FMD) of the brachial artery using a high-resolution vascular ultrasound with a 10-MHz linear array transducer. FMD is expressed as the percentage increase in diameter at the Week 6 visit from pre-dosing with Intralipid to 12 hours during Intralipid infusion.|Pre-dose (Week 6), within 12 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.|||percent change in diameter||Standard Deviation|Mean
2580408|NCT02406586|Primary|Change in Flow-mediated Dilation|The change in endothelium-dependent vascular reactivity will be measured by flow-mediated dilation (FMD) of the brachial artery using a high-resolution vascular ultrasound with a 10-MHz linear array transducer. FMD is expressed as the percentage increase in diameter at the baseline visit from pre-dosing with Intralipid to 24 hours during Intralipid infusion|Pre-dose (Baseline), within 24 hours at Baseline visit|One subject on the salsalate arm withdrew from the study was not included in the baseline analysis population.|||percent change in diameter||Standard Deviation|Mean
2580409|NCT02406586|Primary|Change in Flow-mediated Dilation|The change in endothelium-dependent vascular reactivity will be measured by flow-mediated dilation (FMD) of the brachial artery using a high-resolution vascular ultrasound with a 10-MHz linear array transducer. FMD is expressed as the percentage increase in diameter at the baseline visit from pre-dosing with Intralipid to 12 hours during Intralipid infusion.|Pre-dose (Baseline), within 12 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.|||percent change in diameter||Standard Deviation|Mean
2580410|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 24 hours during Intralipid infusion.|Pre-dose (Week 6), within 24 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.|||mmHg||Standard Deviation|Mean
2580411|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 20 hours during Intralipid infusion.|Pre-dose (Week 6), within 20 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.|||mmHg||Standard Deviation|Mean
2580412|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 16 hours during Intralipid infusion.|Pre-dose (Week 6), within 16 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.|||mmHg||Standard Deviation|Mean
2580413|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 12 hours during Intralipid infusion.|Pre-dose (Week 6), within 12 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.|||mmHg||Standard Deviation|Mean
2580414|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure from at Week 6 from pre-dosing with Intralipid to 8 hours during Intralipid infusion.|Pre-dose (Week 6), within 8 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.|||mmHg||Standard Deviation|Mean
2580431|NCT02406495|Secondary|Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied).|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
2581536|NCT02391363|Secondary|Hospital Admissions at 6 Months|Number of participants who were admitted to a hospital in the past 3 months.|Baseline, 6 months|134 participants who completed baseline assessment.|||Participants|||Count of Participants
2580415|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at Week 6 from pre-dosing with Intralipid to 4 hours during Intralipid infusion.|Pre-dose (Week 6), within 4 hours at Week 6 visit|7 subjects withdrew from the study prior to the Week 6 visit. Data was also not collected for one additional subject.|||mmHg||Standard Deviation|Mean
2580416|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 24 hours during Intralipid infusion.|Pre-dose (Baseline), within 24 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.|||mmHg||Standard Deviation|Mean
2580417|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 20 hours during Intralipid infusion.|Pre-dose (Baseline), within 20 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.|||mmHg||Standard Deviation|Mean
2580418|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 16 hours during Intralipid infusion.|Pre-dose (Baseline), within 16 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.|||mmHg||Standard Deviation|Mean
2580419|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 12 hours during Intralipid infusion.|Pre-dose (Baseline), within 12 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.|||mmHg||Standard Deviation|Mean
2580420|NCT02406586|Primary|Change in Systolic Blood Pressure|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. from Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 8 hours during Intralipid.|Pre-dose (Baseline), within 8 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.|||mmHg||Standard Deviation|Mean
2580421|NCT02406586|Primary|Change in Systolic Blood Pressure.|Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 24-hour infusion with subjects in supine position. Change is the difference in systolic blood pressure at the baseline visit from pre-dosing with Intralipid to 4 hours during Intralipid infusion.|Pre-dose (Baseline), within 4 hours at Baseline visit|One subject in the salsalate arm withdrew from the study was not included in the baseline analysis population.|||mmHg||Standard Deviation|Mean
2580422|NCT02406573|Primary|Change From Baseline for 5 Face Emoticon Scale|Scale to score their comfort/discomfort that ranges from -2 to +2 where a -2 is considered very comfortable and a +2 is considered very uncomfortable.|Day 2|Thirty (30) subjects received study product and completed the study.|||Units on a scale||Standard Deviation|Mean
2580423|NCT02406573|Primary|Change From Baseline for Dentin Sensitivity Cold Water as Assessed by the Schiff Index|The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.|Day 1||||Units on a scale||Standard Deviation|Mean
2580424|NCT02406573|Primary|Change From Baseline for Visual Analog Scale - Cold Water|Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced.|Day 1|Thirty (30) subjects received study product and completed the study.|||Units on a scale||Standard Deviation|Mean
2580425|NCT02406495|Secondary|Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D|Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week||||percentage of participants|||Number
2580426|NCT02406495|Secondary|Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D|Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.|Baseline and 1 Week||||percentage of participants|||Number
2580435|NCT02406495|Primary|Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D|"Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week.~Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement"|Baseline and 1 Week||||percentage of mean lens tightness||Standard Deviation|Mean
2580436|NCT02406495|Primary|Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D|"Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week.~(Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)."|Baseline and 1 Week||||percentage of eyes|||Number
2580437|NCT02406495|Primary|Lens Fit, Centration - Filcon IV 1 and Ocufilcon D|Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable|Baseline and 1 Week||||percentage of eyes|||Number
2580438|NCT02406495|Secondary|Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D|Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel).|Baseline and 1 Week||||units on a scale||Standard Deviation|Mean
2580439|NCT02406495|Secondary|Visual Acuity - Filcon IV 1 and Ocufilcon D|Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity).|Baseline and 1 Week||||LogMAR||Standard Deviation|Mean
2580440|NCT02406443|Secondary|Change in Effective Renal Plasma Flow (ERPF)|ERPF (para-aminohippurate clearance) 3Hrs post-study drug administration after 1 month compared to ERPF at 3Hhrs post-study drug administration after 1 dose, sitagliptin vs placebo|3 Hrs post-administration after 1 month and after 1 dose||||ml per min per 1.73 m2||Standard Deviation|Mean
2580441|NCT02406443|Secondary|Change in Systolic Blood Pressure (SBP), Non-invasive Cardiac Output Monitoring|SBP by Non-Invasive cardiac output monitoring at 3Hrs post- study drug administration after 1 month compared to SBP by Non-invasive cardiac output monitoring at 3Hrs after 1 dose, sitagliptin vs placebo|3 Hrs post-administration after 1 month and after 1 dose||||mmHg||Standard Deviation|Mean
2580442|NCT02406443|Secondary|Change From Baseline in SDF-1alpha^3-67 (Truncated) Measured by Tandem Mass Spectrometry With Antibody-based Affinity Enrichment|Plasma concentration of SDF-1alpha^3-67 (intact) measured by quantitative mass spectrometry methods after antibody-based affinity enrichment, sitagliptin vs. placebo|3Hrs vs baseline after 1 dose||||ng per mL||Standard Deviation|Mean
2580443|NCT02406443|Secondary|Change From Baseline in SDF-1alpha^1-67 (Intact) Measured by Immunoaffinity and Tandem Mass Spectrometry|Plasma concentration of SDF-1alpha^1-67 (intact) measured by quantitative mass spectrometry methods after antibody-based affinity enrichment, sitagliptin vs. placebo|3 Hr vs. baseline after 1 dose||||ng per mL||Standard Deviation|Mean
2580444|NCT02406443|Secondary|Change in Fractional Excretion of Lithium (FELi)|FELi at 3 Hr post-study drug administration after 1 month compared to FELI at 3hrs post-study drug administration after 1 dose, sitagliptin vs. placebo|3 Hrs post-administration after 1 month and after 1 dose||||percentage of change||Standard Deviation|Mean
2580445|NCT02406443|Secondary|Change in Glomerular Filtration Rate (GFR)|Measured GFR (Inulin Clearance) at 3Hrs post study-drug after 1 month compared to Measured GFR at 3Hrs post-study drug after 1 dose, sitagliptin vs. placebo|3 Hrs post-administration after 1 month and after 1 dose||||ml per min per 1.73 m2||Standard Deviation|Mean
2580446|NCT02406443|Primary|Percent Change in Fractional Excretion of Sodium (FENA)|FENA at 3Hrs post-study drug administration after 1 month compared to FENA at 3Hrs post-study drug administration after 1 dose expressed as percent change, sitagliptin vs. placebo|3 Hrs post-administration after 1 month and after 1 dose||||percentage of change||Standard Deviation|Mean
2580447|NCT02406261|Secondary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)|"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation."|Cohort A: Baseline to Study Completion (Up to Day 50); Cohort B: Baseline to Study Completion (Up to Day 70)|Participants who received at least one dose of study drug.|||Participants|||Count of Participants
2580448|NCT02406261|Secondary|Number of Participants With One or More Serious Adverse Events(s) Considered by the Investigator to be Related to Study Drug Administration||Cohort A : Baseline to Study Completion (Up to Day 50); Cohort B: Baseline to Study Completion (Up to Day 70)|Participants who received at least one dose of study drug.|||Participants|||Count of Participants
2580449|NCT02406261|Primary|PK Profile for Donepezil: AUC(0-∞)||Day 1 and 28: predose 0.5,1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96,120, 216, 288, and 360 hours (Cohort B)|Participants who received at least one dose of study drug and had evaluable PK data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2580450|NCT02406261|Primary|PK Profile for Midazolam: AUC(0-∞) Oral and IV Dose||Day 1, 3, 17, 35, and 37: Predose, 0.25, 0.5, 1, 2, 3, 5, 8, and 12 hours (Cohort A)|Participants who received at least one dose of study drug and had evaluable PK data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2580451|NCT02406261|Primary|PK Profile for Simvastatin: AUC(0-∞)||Day 2 and 36: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours (Cohort A)|Participants who received at least one dose of study drug and had evaluable PK data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2580452|NCT02406261|Primary|Pharmacokinetic (PK): Area Under the Curve Zero to Infinity (AUC[0-∞]) for LY3314814||Day 4: Predose, 0.5, 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours (Cohort A)|Participants who received at least one dose of study drug and had evaluable PK data.|||Nanogram * hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2580453|NCT02406248|Primary|Number of Participants With Major Cardiovascular Events|Evaluation of major cardiovascular events including cardiovascular death, myocardial infarction or stroke|during 1year follow up with ticagrelor treatment||||Participants|||Count of Participants
2580454|NCT02406248|Primary|Number of Participants With Other Serious Adverse Event (SAEs)|Evaluation of serious adverse events other than bleedings|during 1year follow up with ticagrelor treatment||||Participants|||Count of Participants
2580458|NCT02406027|Secondary|Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Tau Protein and Phosphorylated Tau (p-Tau) Protein Level|The CSF samples were obtained for measuring levels of Tau protein and phosphorylated (p)-tau protein. Participants were classified as asymptomatic at risk: cognitively and functionally normal (CDR score =0), but with biomarker pattern consistent with early stage AD (preclinical stage); and prodromal: had some limited cognitive impairment (CDR =0.5), and still functionally normal, with biomarker pattern consistent with early stage (predementia) AD, but had as of yet no dementia (predementia stage). Here, 'Number analyzed=0' signifies that either CSF concentration was below lower limit of quantification for assay or sample was collected under parent study 54861911ALZ2002 (NCT02260674).|Baseline, DB Day 1 and DB Week 52|The Double-blind (DB) Safety Analysis Set included all participants (asymptomatic at risk and prodromal at baseline) who received study treatment during Period 1. Here ‘n’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure at a given time point.|||Percent change||Standard Deviation|Mean
2580459|NCT02406027|Secondary|Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels|Plasma samples were obtained for measuring levels of different ABeta fragments such as ABeta 1-38, ABeta 1-40, ABeta 1-42. ABeta fragments of different length were produced by cleavage of APP by beta-secretase (BACE) and gamma-secretase complex in different peripheral tissues, including white blood cells and were measured in plasma. Participants classified as asymptomatic at risk: cognitively and functionally normal (CDR score =0), but with biomarker pattern consistent with early stage AD (preclinical stage); and prodromal: had some limited cognitive impairment (CDR =0.5), and still functionally normal, with biomarker pattern consistent with early stage (predementia) AD, but had as of yet no dementia (predementia stage). Here, 'Number analyzed=0' signifies that either CSF concentration was below lower limit of quantification for assay or sample was collected under parent study 54861911ALZ2002 (NCT02260674).|Baseline, DB Day 1, DB Week 24, and DB Week 52|The Double-blind (DB) Safety Analysis Set included all participants (asymptomatic at risk and prodromal at baseline) who received study treatment during Period 1. Here ‘n’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure at a given time point.|||Percent change||Standard Deviation|Mean
2580460|NCT02406027|Secondary|Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Soluble Amyloid Precursor Protein (sAPP) Fragments (sAPP-alpha and sAPP-beta) Levels|The CSF samples were obtained for measuring levels of different soluble amyloid precursor protein (sAPP) fragments (sAPP-alpha, sAPP-beta). Participants were classified as asymptomatic at risk: cognitively and functionally normal (CDR score =0), but with biomarker pattern consistent with early stage alzheimer's disease (AD) (preclinical stage); and prodromal: had some limited cognitive impairment (CDR =0.5), and still functionally normal, with biomarker pattern consistent with early stage (predementia) AD, but had as of yet no dementia (predementia stage). Here, 'Number analyzed=0' signifies that either CSF concentration was below lower limit of quantification for assay or sample was collected under parent study 54861911ALZ2002 (NCT02260674).|Baseline, DB Day 1 and DB Week 52|The Double-blind (DB) Safety Analysis Set included all participants (asymptomatic at risk and prodromal at baseline) who received study treatment during Period 1. Here ‘n’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure at a given time point.|||Percent change||Standard Deviation|Mean
2580461|NCT02406027|Secondary|Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels|CSF samples were obtained for measuring levels of different ABeta fragments such as ABeta 1-37, ABeta 1-38, ABeta 1-40, and ABeta 1-42. ABeta fragments of different length produced by cleavage of amyloid precursor protein (APP) by beta-secretase (BACE) and gamma-secretase complex in brain and excreted into CSF. Participants were classified as asymptomatic at risk: cognitively and functionally normal (Clinical Dementia Rating Scale score [CDR] =0), but with biomarker pattern consistent with early stage AD (preclinical stage); and prodromal: had some limited cognitive impairment (CDR =0.5), and still functionally normal, with biomarker pattern consistent with early stage (predementia) AD, but had as of yet no dementia (predementia stage). Here, 'Number analyzed=0' signifies that either CSF concentration was below lower limit of quantification for assay or sample was collected under parent study 54861911ALZ2002 (NCT02260674).|Baseline, Double-blind (DB) Day 1 and DB Week 52|The Double-blind (DB) Safety Analysis Set included all participants (asymptomatic at risk and prodromal at baseline) who received study treatment during Period 1. Here ‘n’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure at a given time point.|||Percent change||Standard Deviation|Mean
2580462|NCT02406027|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between administration of study drug and up to 3 years that were absent before treatment or that worsened relative to pre-treatment state. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to 3 years|Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).|||Participants|||Number
2580463|NCT02405962|Secondary|Parents' Quality of Life|"The Pediatric Asthma Caregiver's Quality of Life was used to assess the quality of life of the parents in caring for a child with asthma.~This instrument is a 13-question, 7-point Likert scale measuring parental psychosocial well-being with 2 subscales, emotional function and activity limitation. The possible range of each of the subscale score is 1-7 (minimum value = 1, maximum value = 7). Higher scores in the subscales mean better outcomes, that is the parent has a better quality of life.~This instrument had stable reliabilities within the intervals of four weeks (intraclass correlation coefficient (ICC) = 0.80 to 0.85)."|At 6 months after the intervention||||score on a subscale||Standard Error|Mean
2580475|NCT02405962|Secondary|Children's Total Number of Private Practitioner's Clinic Visits Due to Asthma Attacks Over the Past 6 Months|The total number of private practitioner's clinic visits due to asthma attacks of children over the past 6 months by parental reports in self-administered questionnaires|At 6 months after the intervention||||Number of visits||Standard Error|Mean
2600075|NCT02167451|Secondary|Overall Survival|Overall survival for patients who were enrolled and received maraviroc|By day +100||||Participants|||Count of Participants
2580464|NCT02405962|Secondary|Parents' Asthma Management Self-efficacy|"The Parental Asthma Management Self-Efficacy Scale was used to assess the self-efficacy of parents in childhood asthma care.~The instrument consists of 13 questions with two subscales in assessing the self-efficacy of parents in preventing and in managing children's asthma attacks. The parents rated the strength of their beliefs in a variety of situations related to childhood asthma management on a 5-point rating scale from 1 (not at sure) to 5 (completely sure). The possible range of each of the subscale score is 1-5 (minimum value = 1, maximum value = 5). A higher score means a better outcome, that is the parent has better self-efficacy.~This instrument had satisfactory internal consistency (α of each subscale = .77 to .82) and strong construct validity with the self-efficacy of children in managing asthma (r = 0.36)."|At 6 months after the intervention||||score on a subscale||Standard Error|Mean
2580465|NCT02405962|Secondary|Parents' Knowledge in Childhood Asthma Management|"The Asthma Knowledge Questionnaire was used to assess the knowledge level among parents in pediatric asthma management.~This instrument composes of 25 true and false statements to measure parental asthma knowledge, including symptoms, triggers, treatment and prevention (Cronbach's alpha = 0.69).~The possible range of total score is 0-25 (minimum value = 0; maximum value = 25). A higher score means a better outcome, that is the parent has better asthma knowledge."|At 6 months after the intervention||||score on a scale||Standard Error|Mean
2580466|NCT02405962|Secondary|Parents' Psychological Symptoms|"The Depression Anxiety Stress Scale 21 was used to evaluate the psychological symptoms of parents.~This instrument contains 21 statements with 3 subscales assessing the symptoms of depression, anxiety and stress of parents, respectively. The parents rated the degree to which each statement applied to them in the past week on a 4-point Likert scale from 0 (does not apply to me at all) to 3 (applies to me very much, or most of the time).~The subscale scores for depression, anxiety and stress subscale would be multiplied by two. The possible range for each of the subscale score is 0-42 (minimum value = 0, maximum value = 42). Higher scores mean worse outcomes. The cut-off scores indicating at least a mild level of psychological symptoms of an individual are 9 for depression; 7 for anxiety and 14 for stress, respectively.~The Cronbach's alpha for the depression, anxiety, and stress subscales in DASS-21 were 0.82, 0.88 and 0.90, respectively."|At 6 months after the intervention||||score on a subscale||Standard Error|Mean
2580467|NCT02405962|Secondary|Parents' Psychological Adjustment to Their Child's Asthma|"The Parent Experience of Child Illness scale was used to capture the psychological adjustment of parents in caring for a child with asthma.~The Parent Experience of Child Illness scale contains 25 statements with 3 subscales for assessing the illness-specific psychological distress experienced by parents who have a chronically ill child, including Guilt and Worry, Unresolved Sorrow and Anger, and Long-term Uncertainty, together with 1 subscale on perceived Emotional Resources. The possible range of each of the subscale score is 0-4 (minimum value = 0; maximum value = 4). Higher scores in Guilt and Worry, Unresolved Sorrow and Anger, and Long-term Uncertainty mean worse outcomes. A higher score in Emotional Resources means a better outcome.~The Parent Experience of Child Illness scale had adequate internal consistencies (α in each subscale = .72 to .89) and test-retest reliabilities over a 2-week interval (r in each subscale = .83 to .86)"|At 6 months after the intervention||||score on a subscale||Standard Error|Mean
2580468|NCT02405962|Secondary|Parents' Psychological Flexibility|"The Acceptance and Action Questionnaire-II was used to assess the psychological flexibility of the parents.~The parents rated 7 statements on a 7-point Likert scale ranging from 1 (never true) to 7 (always true), for example: My painful experiences and memories make it difficult for me to live a life that I would value. The possible range of the total score is 7-49 (minimum value = 7; maximum value = 49). A higher score means a worse outcome, that is the parent is more psychologically inflexible.~The Acceptance and Action Questionnaire-II possessed good internal consistencies (mean Cronbach's alpha (α) = .84, range α = .86 to .88) and test-retest reliabilities over a 3-month interval (test-retest reliability coefficient (r) = .81) and 12-month interval (r = .79), respectively."|At 6 months after the intervention||||score on a scale||Standard Error|Mean
2580469|NCT02405962|Secondary|Children's Reliever Use Due to Asthma Symptoms Per Week Over the Past 4 Weeks|The days per week that the child requires to use an inhaled bronchodilator to relieve asthma symptoms (either chronic coughing, wheezing, shortness of breath, or chest tightness) over the past 4 weeks, assessed by parental reports in self-administered questionnaires|At 6 months after the intervention||||Number of days||Standard Error|Mean
2580470|NCT02405962|Secondary|Children's Days of Activities Affected by Asthma Symptoms Per Week Over the Past 4 Weeks|The days per week that the child has to slow down or discontinue his/her activities due to asthma symptoms (either chronic coughing, wheezing, shortness of breath, or chest tightness) over the past 4 weeks, assessed by parental reports in self-administered questionnaires.|At 6 months after the intervention||||Number of days||Standard Error|Mean
2580471|NCT02405962|Secondary|Children's Asthma Symptoms During Nighttime Per Week Over the Past 4 Weeks|The nights per week that the child was awakened due to asthma symptoms (either chronic coughing, wheezing, shortness of breath, or chest tightness) during the nighttime over the past 4 weeks, assessed by parental reports in self-administered questionnaires|At 6 months after the intervention||||Number of nights||Standard Error|Mean
2580472|NCT02405962|Secondary|Children's Asthma Symptoms During Daytime Per Week Over the Past 4 Weeks|The days per week that the child presented with asthma symptoms (either chronic coughing, wheezing, shortness of breath, or chest tightness) during the daytime over the past 4 weeks, assessed by parental reports in self-administered questionnaires|At 6 months after the intervention||||Number of days||Standard Error|Mean
2580473|NCT02405962|Secondary|Children's Number of Days of Hospital Stay Due to Asthma Attacks Over the Past 6 Months|The total number of days of inpatient hospital stay due to asthma attacks of children in either the public hospitals under the Hong Kong Hospital Authority and/or the private hospitals over the past 6 months by parental reports in self-administered questionnaires|At 6 months after the intervention||||Number of days of hospital stay||Standard Error|Mean
2580474|NCT02405962|Secondary|Children's Total Number of Hospital Admissions Due to Asthma Attacks Over the Past 6 Months|The total number of hospital admissions due to asthma attacks of children in either the public hospitals under the Hong Kong Hospital Authority and/or the private hospitals over the past 6 months by parental reports in self-administered questionnaires|At 6 months after the intervention||||Number of hospital admissions||Standard Error|Mean
2588794|NCT02301793|Secondary|Rates of All VTE Among Hospitalized Patients|Did the intervention decrease rates of VTE among hospitalized patients?|3-12 months after end of study|Data were not collected||||||
2580476|NCT02405962|Secondary|Children's Total Number of General Outpatient Clinic Visits Due to Asthma Attacks Over the Past 6 Months|The total number of general outpatient clinic visits due to asthma attacks of children over the past 6 months by parental reports in self-administered questionnaires|At 6 months after the intervention||||Number of visits||Standard Error|Mean
2580477|NCT02405962|Primary|Child's Total Number of Emergency Department Visits Due to Asthma Attacks Over the 6 Months Post Intervention|Parental report of the total number of emergency department visits due to asthma attacks of a child in either a / public hospital(s) of the Hong Kong Hospital Authority and/or a private hospital(s) over 6 months post intervention|6 months after the completion of intervention||||Number of visits||Standard Error|Mean
2580478|NCT02405780|Other Pre-specified|Trough Adalimumab Concentration|Blood samples for the quantification of adalimumab concentration in serum were collected prior to dosing (trough samples) at Baseline (Week 0), and at weeks 12, 24 , 30, 54, 76 and 80/EOS.|From Week 0 to Week 80|Analysis of Serum Concentration Data (ng/mL). Repeated measure of pharmacokinetic(s) (PK) trough concentrations at given time-points.|||ng/mL||Standard Deviation|Mean
2580479|NCT02405780|Other Pre-specified|Proportion of Patients Developing Anti-drug Antibodies (ADAs)|"Blood samples for assessment of Anti-Drug antibodies (ADA) were collected prior to dosing (trough samples) at Baseline (Week 0) and at Weeks 12, 24, 30, 54, 76 and 80/EOS.~All ADA activity was listed and summarized for each treatment sequence by time point during the overall treatment period as well as by treatment group for each period (Period I and Period II). Descriptive statistics included absolute counts (n) and percentage (%)."|From Week 0 to Week 80|Number of patients who had an assay result of positive Anti-Drug Antibodies at given time-points.|||Participants|||Count of Participants
2580480|NCT02405780|Secondary|American College of Rheumatology 70 (ACR70) Response Rates From Baseline as a Measure of Efficacy|"An ACR70 response means that the patient achieved a 70% improvement in Tender Joint Count (TJC) and Swollen Joint Count (SJC) and in at least 3 of the other 5 Core Data Set elements listed below:~Acute phase reactant (C-reactive protein,CRP) A high level of CRP in the blood is a marker of inflammation.~Patient global assessment of disease activity assessed on a Visual Analog Scale (VAS) ranging from very well to extremely bad was assessed on a 100 point scale. (from 0 to 100)~Physician global assessment of disease activity assessed on a VAS ranging from very low to very high was assessed on 100 point scale~Patient pain scale assessed on a VAS ranging from very well to extremely bad was assessed on 100 point scale~Disability/functional questionnaire (patient completed Heath Assessment Questionnaire Disability Index (HAQ-DI)) A higher response rate is a better outcome. The minimum possible value is 0% and the maximum possible value is 100%"|From Week 0 to Week 80|Number of patients at a given time-point with an observed ACR70 score defined as a 70% improvement in tender and swollen joints and at least 3 out of 5 other indicators from Baseline_002 (Week 0 of FKB327-002; NCT02260791)|||Participants|||Count of Participants
2580481|NCT02405780|Secondary|American College of Rheumatology 50 (ACR50) Response Rates From Baseline as a Measure of Efficacy|"An ACR50 response means that the patient achieved a 50% improvement in Tender Joint Count (TJC) and Swollen Joint Count (SJC) and in at least 3 of the other 5 Core Data Set elements listed below:~Acute phase reactant (C-reactive protein, CRP) A high level of CRP in the blood is a marker of inflammation.~Patient global assessment of disease activity assessed on a Visual Analog Scale (VAS) ranging from very well to extremely bad was assessed on a 100 point scale. (from 0 to 100)~Physician global assessment of disease activity assessed on a VAS ranging from very low to very high was assessed on 100 point scale~Patient pain scale assessed on a VAS ranging from very well to extremely bad was assessed on 100 point scale~Disability/functional questionnaire (patient completed Heath Assessment Questionnaire Disability Index (HAQ-DI)) A higher response rate is a better outcome. The minimum possible value is 0% and the maximum possible value is 100%"|From Week 0 to Week 80|Number of patients at a given time-point with an observed ACR50 score defined as a 50% improvement in tender and swollen joints and at least in 3 out of 5 other indicators from Baseline_002 (Week 0 of FKB327-002; NCT02260791)|||Participants|||Count of Participants
2580482|NCT02405780|Secondary|American College of Rheumatology 20 (ACR20) Response Rates From Baseline as a Measure of Efficacy|"An ACR20 response means that the patient achieved a 20% improvement in Tender Joint Count (TJC) and Swollen Joint Count (SJC) and a 20% improvement in at least 3 of the other 5 Core Data Set elements listed below:~Acute phase reactant (C-reactive protein, CRP) A high level of CRP in the blood is a marker of inflammation.~Patient global assessment of disease activity assessed on a Visual Analog Scale (VAS) ranging from very well to extremely bad was assessed on a 100 point scale. (from 0 to 100)~Physician global assessment of disease activity assessed on a VAS ranging from very low to very high was assessed on 100 point scale~Patient pain scale assessed on a VAS ranging from very well to extremely bad was assessed on 100 point scale~Disability/functional questionnaire (patient completed Heath Assessment Questionnaire Disability Index (HAQ-DI)) A higher response rate is a better outcome. The minimum possible value is 0% and the maximum possible value is 100%"|From Week 0 to Week 80|Number of patients at a given time-point with an observed ACR20 score defined as a 20% improvement in tender and swollen joints and at least 3 out of 5 other indicators from Baseline_002 (Week 0 of FKB327-002; NCT02260791)|||Participants|||Count of Participants
2580483|NCT02405780|Secondary|Changes in Disease Activity Score 28 Based on C Reactive Protein (DAS28 CRP) Score Compared to Baseline as a Measure of Efficacy|"The DAS28 score is a combined index that has been developed to measure the disease activity in patients with Rheumatoid arthritis (RA) and has been extensively validated for the use in clinical studies. The DAS28-CRP assessment involved evaluating the number of tender (TJC) and the swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (Visual analogue scale (VAS) from 0-100, very well to extremely bad). The individual results are summarized using a formula. DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.~During the FKB327-003 study for Period I and Period II the DAS28-CRP score was compared to Baseline in study FKB327-002 (NCT02260791)."|From Week 0 of FKB327-002 to Week 80|DAS28-CRP and change from Baseline in Study FKB327-002 (i.e. Baseline_002) in DAS28-CRP were summarized by overall treatment sequence and visit as well as by treatment for each period (Period I and Period II)|||units on a scale||Full Range|Mean
2580694|NCT02404025|Secondary|The Trough Concentrations of Eltrombopag Following Repeat Doses of at 75 mg, 50 mg and 25 mg|Blood samples will be collected after repeat (14 days) doses of eltrombopag 75, 50, 25 mg to determine the plasma eltrombopag concentration prior to the next dose.|day 15|pharmacokinetic population:The PK population was defined as all subjects whose PK samples were collected and measured.|||ng/mL||Standard Deviation|Mean
2580484|NCT02405780|Primary|Summary of Most Common Clinical Significant Laboratory Parameters Reported as Adverse Events (Reported by ≥1% of the Patients)|Clinical Laboratory tests for hematology and serum chemistry were performed by the sites and analysed at a Central Laboratory. Urine dip-stick tests were performed by the sites. Laboratory samples were taken at the following time-points (weeks): 0; 4; 8; 12; 24; 30; 42; 54; 66; 76 and 80/End of Study (EOS). Each result outside its normal range was review and assessed by the investigator whether or not it was Clinically Significant (CS) or Not Clinically Significant (NCS) CS laboratory abnormalities were recorded as AEs.|From Week 0 to Week 80||||participants|||Number
2580485|NCT02405780|Primary|Changes in Vital Signs as a Measure of Safety - Temperature Measurements|"Temperature measurements forms part of the vital signs which was one of the continuous safety measurements for the study primary endpoint.~Temperature was measured at week 0, week 4, week 8, week 12, week 24 and at week 80 or at End of Study (EOS).~Temperature with change from Baseline_002 were summarized by treatment sequence over the whole study period.~Baseline_002 is defined as the last non-missing measurement collected prior to the first study medication administration at Week 0 from Study FKB327-002 (NCT02260791)."|From Week 0 to Week 80|The number of patients in the Safety Analysis Set; is equal to the number of patients who entered Period I. The number of patients at the following visits is the number of patients who at a given timepoint had a measurement completed for the Safety Analysis Set.|||Centigrades||Full Range|Median
2580486|NCT02405780|Primary|Changes in Vital Signs as a Measure of Safety - Pulse Rate|"Pulse rate is part of Vital Signs which were part of the subject safety evaluations. Pulse rate was measured at the following time-points: Weeks 0, 4, 8, 12, 24 and 80/End of Study (EOS). Pulse Rate with changes from Baseline_002 (NCT022600791) was summarized by treatment sequence over the whole study period for each visit.~Baseline_002 is defined as the last non-missing measurement collected prior to the first study medication administered at Week 0 from Study FKB327-002."|From Week 0 to Week 80|The number of patients in the Safety Analysis Set; is equal to the number of patients who entered Period I. The number of patients at the following visits is the number of patients who at a given time point had a measurement completed for the Safety Analysis Set.|||Beats per minute (bpm)||Full Range|Median
2580487|NCT02405780|Primary|Changes in Vital Signs as a Measure of Safety - Diastolic Blood Pressure|"Diastolic Blood Pressure is part of Vital Signs which were part of the subject safety evaluations. Diastolic Blood Pressure was measured at the following time-points: Week 0, Week 4, Week 8, Week 12, Week 24 and Week 80/End o Study (EOS). Diastolic Blood Pressure with changes from Baseline_002 (NCT022600791) was summarized by treatment sequence over the whole study period for each visit measured.~Baseline_002 is defined as the last non-missing measurement collected prior to the first study medication administered at Week 0 from Study FKB327-002."|From Week 0 to Week 80|The number of patients in the Safety Analysis Set; is equal to the number of patients who entered Period I. The number of patients at the following visit is the number of patients who at a given timepoint had a measurement completed for the Safety Analysis Set.|||mmHg||Full Range|Median
2580488|NCT02405780|Primary|Changes in Vital Signs as a Measure of Safety - Systolic Blood Pressure|"Systolic Blood Pressure is part of Vital Signs which were part of the subject safety evaluations. Systolic Blood Pressure was measured at the following time-points: Week 0, Week 4, Week 8, Week 12, Week 24 and Week 80/End o Study (EOS). Systolic Blood Pressure with changes from Baseline_002 (NCT022600791) was summarized by treatment sequence over the whole study period for each visit.~Baseline_002 is defined as the last non-missing measurement collected prior to the first study medication administered at Week 0 from Study FKB327-002."|From Week 0 to Week 80|The number of patients in the Safety Analysis Set; is equal to the number of patients who entered Period I. The number of patients at the following visit is the number of patients who at a given timepoint had a measurement completed for the Safety Analysis Set.|||mmHg||Full Range|Median
2580489|NCT02405780|Primary|Number of Patients With Serious Adverse Events as a Measure of Safety in Period II - Single Treatment Period|"Period II: at week 30 all patients were transferred to receive FKB327.~Each subject was counted once within each System Organ Class (SOC) and Preferred Term (PT). Death defined as a fatal outcome of a (S)AE.~SAEs were followed until resolution, the investigator confirmed the event was unlikely to resolve or the patient was lost to follow-up."|Period II: from Week 30 up to Week 80|Each patient was counted once within each System Organ Class (SOC) and Preferred Term (PT). Death defined as a fatal outcome of a (S) AE.|||Participants|||Count of Participants
2580490|NCT02405780|Primary|Number of Patients With Serious Adverse Events as a Measure of Safety Per Treatment Group in Period I|"A Serious Adverse Event (SAE) was defined in the Protocol as: Death; or a Life-threatening Adverse Event (AE); Inpatient Hospitalization; Persistant or significant disability or incapacity; A congenital anomaly/birth defect; An important medical event that may not have resulted in death, have been life-threatening, or required hospitalization, but may have jeopardized the patient and may have required medical intervention to prevent 1 of the outcomes listed in this definition.~SAEs were followed until resolution, the investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up."|Period I: from Week 0 up until Week 30|Each patient was counted once within each System Organ Class (SOC) and Preferred Term (PT). Death defined as a fatal outcome of a (S) AE.|||participants|||Number
2580491|NCT02405780|Primary|Number of Patients With Adverse Events as a Measure of Safety in Period II - Single Treatment Period|From week 30 all subjects were transferred to receive FKB327 treatment. Adverse Events were contentiously monitored and recorded during Period II. For patients discontinuing the study prematurely, a follow-up period of 4 weeks was added to the Early Termination Visit. The data for Period II is based on the number of patients in the Safety Analysis Set that entered Period II.|Period II: from Week 30 up to Week 80||||Participants|||Count of Participants
2580492|NCT02405780|Primary|Number of Patients With Adverse Events as a Measure of Safety Per Treatment Group in Period I|"Period I: Patients were carefully monitor for Adverse Events from signing of informed consent until week 30 and thereafter during Period II of the study. For patients who discontinued early, a follow-up period of 4 weeks was added to the Early Termination Visit.~The investigator actively asked the patients for Adverse Events. Patients spontaneously reported Adverse Events to the Investigator during clinic visits or in between visits."|Period I: from Week 0 up until Week 30;|Each patient was counted once within each System Organ Class (SOC) and Preferred Term (PT). A patient may have had multiple events counted. Treatment Emergen Adverse Events (TEAE) defined as AEs that started or increased in severity after the first study dose and counted under the treatment arm.|||participants|||Number
2580493|NCT02405442|Secondary|Percentage of Participants Achieving Mucosal Healing (SES-CD Size-of-Ulcer Subscore = 0) at Week 8 of the Double-Blind Phase|The SES-CD evaluates 4 endoscopic variables: ulcer size, ulcerated surface, affected surface, and presence of narrowings. The SES-CD size-of-ulcer subscore ranges from 0 (none) to 3 (very large). Mucosal healing at Week 8 was defined as the size-of-ulcer subscore for segments with non-zero baseline value changes to zero at Week 8 AND the size-of-ulcer subscore for segments with zero value at baseline remain zero at Week 8. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing SES-CD size-of-ulcer subscore at Week 8 analysis visit were imputed as not achieving Mucosal Healing.|Week 8|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2580494|NCT02405442|Secondary|Percentage of Participants Achieving CDAI Remission (CDAI ≤ 150) at Week 8 of the Double-Blind Phase|Clinical remission was defined as Crohn's Disease Activity Index (CDAI) ≤ 150 at Week 8. CDAI is used as a measure of clinical response and remission. It includes 8 variables of patient-reported symptoms and objective variables: stool count, abdominal pain, general well-being, complications, use of anti-diarrheal medications, presence of abdominal mass, hematocrit values, and weight. It has a minimum range of 0 and no upper bound, with higher scores indicating greater disease activity. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing CDAI score at Week 8 analysis visit were imputed as not achieving CDAI Remission.|Week 8|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2580495|NCT02405442|Primary|Percentage of Participants Achieving Endoscopic Response (≥ 50% Reduction From Baseline SES-CD) at Week 8 of the Double-Blind Phase|Endoscopic response was defined as ≥ 50% reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 8. The SES-CD evaluates 4 endoscopic variables: ulcer size, ulcerated surface, affected surface, and presence of narrowings. The total SES-CD is calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with missing SES-CD value at Week 8 analysis visit were imputed as not achieving Endoscopic Response.|Week 8|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2580496|NCT02405442|Primary|Percentage of Participants Achieving Clinical Response (PRO2 Score ≤ 8) at Week 8 of the Double-Blind Phase|Clinical response was defined as patient-reported outcomes (PRO2) score ≤ 8 at Week 8. PRO2 is the weighted average of the 2 variables of frequency of liquid or very soft stool and abdominal pain, based on 7-day participant diary data. The PRO2 score has a minimum score of 0 and has no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain. Week 8 refers to the analysis window of Day 43 to Day 70 and prior to the first Open-Label dose date. Participants with a missing PRO2 value at the Week 8 analysis visit were imputed as not achieving the Clinical Response.|Week 8|Full Analysis Set included all randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2580497|NCT02405429|Primary|Difference Between Rectal and Axillary Temperatures|Rectal temperature minus axillary temperature|Within 2 minutes of each other|Hospitalized neonates|||degrees Celsius||Standard Deviation|Mean
2580498|NCT02405429|Primary|Difference Between Temporal Artery and Rectal Temperatures|Rectal temperature minus temporal artery temperature|Within 2 minutes of each other|Hospitalized neonates|||degrees Celsius||Standard Deviation|Mean
2580499|NCT02405429|Primary|Rectal Temperature|With thermistor probe and telethermometer|Single measurement within 2 minutes of temporal artery and axillary temperature measurements|Hospitalized neonates|||degrees Celsius||Standard Deviation|Mean
2580500|NCT02405429|Primary|Axillary Temperature|With commercial digital thermometer|Single measurement within 2 minutes of temporal artery and rectal temperature measurements|Hospitalized neonates|||degrees Celsius||Standard Deviation|Mean
2580501|NCT02405429|Primary|Temporal Artery Temperature|With commercial infrared temporal artery thermometer|Mean of 2 measurements within 2 minutes of each other and within 2 minutes of axillary and rectal temperature measurements|Hospitalized neonates|||degrees Celsius||Standard Deviation|Mean
2580502|NCT02405390|Secondary|Time for Intubation|Time from when the laryngoscope blade enters the mouth until the endotracheal tube enters the vocal cords. No follow up after that.|During the process of intubation (less than one minute)||||second||Standard Deviation|Mean
2580503|NCT02405390|Primary|Head Motion - Extension or Flexion|Head motion will only be measured while the patient is being endotracheally intubated. Usually this takes less than one minute. No follow up after that.|During the process of intubation (less than one minute)||||degrees of extension||Standard Deviation|Mean
2580504|NCT02405195|Secondary|Development of Acute Kidney Injury (AKI)|AKI according to AKIN criteria|72 hours|||||||
2580505|NCT02405195|Secondary|Excretion of NAG|Urinary biomarker of tubular renal injury|24 hours|||||||
2580506|NCT02405195|Primary|Renal Oxygenation|Renal oxygen extraction, defined as renal oxygen consumption divided by renal oxygen delivery|6 hours||||fraction||Standard Deviation|Mean
2580507|NCT02405195|Primary|Glomerular Filtration Rate (GFR)|GFR measured by renal extraction of 51Cr-EDTA|6 hours||||ml per minute per 1.73 m2 body surface||Standard Deviation|Mean
2580508|NCT02405195|Primary|Renal Blood Flow (RBF)|Renal blood flow measured with PAH clearance|6 hours||||ml per minute per 1.73 m2 body surface||Standard Deviation|Mean
2580509|NCT02405091|Secondary|Clinical Global Impression - Global Improvement of Tardive Dyskinesia (CGI-TD) at Week 48|Clinician's perspective of the participant's overall improvement of TD symptoms since initiation of study drug dosing. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).|Week 48|Safety analysis set: includes all participants who were enrolled in the study and received study drug, with the following two exclusions: (a) participants who withdrew from the study and returned all previously dispensed study drug with all doses present, and (b) participants who had no post-baseline data collected|||score on a scale||Standard Error|Mean
2580699|NCT02404025|Secondary|Degree of Exposure to Eltrombopag : Cumulative Dose|The cumulative dose of drug administered to the subject will be calculated.|Week 104|safety population:The safety population consisted of all subjects who received at least one dose of eltrombopag.|||mg||Standard Deviation|Mean
2580510|NCT02405091|Secondary|Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; On-Site AIMS Raters|Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by On-Site AIMS raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.|Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52|Safety analysis set: includes all participants who were enrolled in the study and received study drug, with the following two exclusions: (a) participants who withdrew from the study and returned all previously dispensed study drug with all doses present, and (b) participants who had no post-baseline data collected|||score on a scale||Standard Error|Mean
2580511|NCT02405091|Secondary|Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; Central AIMS Video Raters|Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by the blinded, Central AIMS Video Raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.|Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52|Safety analysis set: includes all participants who were enrolled in the study and received study drug, with the following two exclusions: (a) participants who withdrew from the study and returned all previously dispensed study drug with all doses present, and (b) participants who had no post-baseline data collected|||score on a scale||Standard Error|Mean
2580512|NCT02405091|Secondary|Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 48; On-site AIMS Raters|Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by On-Site AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.|Baseline and Week 48|Safety analysis set: includes all participants who were enrolled in the study and received study drug, with the following two exclusions: (a) participants who withdrew from the study and returned all previously dispensed study drug with all doses present, and (b) participants who had no post-baseline data collected|||score on a scale||Standard Error|Mean
2580513|NCT02405091|Primary|Number of Participants Monitored for Long-Term Safety of Valbenazine|Number of participants monitored for long-term safety through reporting of treatment-emergent adverse events and monitoring of vital signs, clinical laboratory values, and ECG. Summaries of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared.|52 weeks|Safety analysis set: includes all participants who were enrolled in the study and received study drug, with the following two exclusions: (a) participants who withdrew from the study and returned all previously dispensed study drug with all doses present, and (b) participants who had no post-baseline data collected|||Participants|||Count of Participants
2580514|NCT02404792|Secondary|Changes in Inflammation (Interleukin-6 [IL-6], Soluble Tumor Necrosis Factor Receptors 1 and TNF-alpha.|The primary outcome is change from 0 to 24 weeks. These changes in inflammation are measured at baseline (pre-exercise) and at 24 weeks (post exercise).|Baseline and 24 weeks||||percentage of change||95% Confidence Interval|Mean
2580515|NCT02404792|Secondary|Changes in Insulin-like Growth Factor (IGF)-1|Measures at baseline and following 24 weeks of exercise|24 weeks|Missing data on one participant with HIV that completed the study. Data listed below ONLY includes data on persons with measurements at both baseline and week 24.|||IGF-1 (ng/mL)||95% Confidence Interval|Geometric Mean
2580516|NCT02404792|Primary|Time to Rise From a Chair 10 Times (Modified From the Original Short Physical Performance Battery)|Chair rise time is measured as a continuous variable of time to stand up from a sitting position 10 times. Lower number = faster; larger number = slower|24 weeks|37 and 32 had baseline values; 29 and 27 (uninfected and with HIV, respectively) completed 24 weeks.|||percentage change||95% Confidence Interval|Mean
2580517|NCT02404649|Secondary|To Assess Implant Survival||2 years|||||||
2580518|NCT02404649|Secondary|Evaluate Crestal Bone Levels||2 years|||||||
2580519|NCT02404649|Secondary|Level of Bone Maturation||2 years|||||||
2580520|NCT02404649|Primary|Resonance Frequency Values of Dental Implants|Implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100 and is measured by implant stability meters instruments using resonance frequency analysis (RFA) technique. The acceptable stability range lies between 55-85 ISQ. Lower initial stability will normally increase with time due to the lower mechanical stability being enforced by the bone remodeling process (osseointegration). The overall average ISQ value of all implants over time is approximately 70. A significant decrease in ISQ indicates a potential problem and should be considered an early warning. For each time period three measurements were taken from three different positions on the dental implant and the measurements were averaged for each time period.|8 months||||units on a scale||Standard Deviation|Mean
2580521|NCT02404610|Primary|Patients With Clinical Signs of Respiratory Depression or Sub Clinical Respiratory Depressions Measured by Capnography and Pulse Oximetry.|adverse respiratory events|From start of procedure until the patient has returned to baseline mental status after the conclusion of the sedation procedure, an expected average time of 30 minutes|patients undergoing procedural sedation in the ED|||Participants|||Count of Participants
2580522|NCT02404545|Secondary|Number of Participants Who Develop Mesh Related Complications|"Assessed by physical examination including:~Mesh erosion and infection~Stomal stenosis and necrosis~Frequency of stoma pouch appliance changes.~Record by physical exam the incidence of parastomal hernia at 5 years."|60 months|The study required a minimum of 13 participants enrolled per arm for analysis of this outcome measure. Due to the manufacturer's (Ethicon) termination of the Physiomesh device, the study was prematurely terminated with fewer than minimum number of participants required on each arm, and the data were not analyzed.||||||
2580523|NCT02404545|Primary|Rate of Reduction of the Incidence of Parastomal Hernia|Rate of reduction of the incidence of parastomal hernia in study participants, as assessed by physical examination|18 months|The study required a minimum of 13 participants enrolled per arm for analysis of this outcome measure. Due to the manufacturer's (Ethicon) termination of the Physiomesh device, the study was prematurely terminated with fewer than minimum number of participants required on each arm, and the data were not analyzed.||||||
2580524|NCT02404532|Secondary|Number of Participants With AEs Due Study Treatment and MIND1 System|Safety and tolerability of the system components was assessed by the device-related AEs, non-serious AEs (NSAEs), serious AEs (SAEs), AEs leading to discontinuation, and unanticipated adverse device effects.|At screening visit (Day -14 to 0), Visit 1 (Day 1) and safety Follow-up (Day 7 [+1] days after the last trial visit)|The Safety sample included all participants who had ingested at least 1 dose of a placebo-embedded IEM, which was the same as the ITT dataset.|||participants|||Number
2580525|NCT02404532|Secondary|The Latency Period Between the Patch Detection of an Ingestion Event (eg, the Acquisition Time Stamp) and the Detection of the Ingestion Event in the Otsuka Cloud Server (eg, Server Time Stamp).|All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). The time of each ingestion of an IEM was recorded. The compatible computing device (eg, smartphone) was checked at 30-minute intervals for the presence of a timeline ingestion tile and the time was recorded. To measure the latency period between the patch detection of an ingestion event and the detection of the ingestion event on the Otsuka Cloud Server which displayed on the MIND1 System compatible computing device (eg, smartphone) as a timeline ingestion tile after each scheduled ingestion event. The various information transmissions measured were patch Acquisition of IEM to Medical Device Data Systems (MDDS), MDDS to Otsuka software application registration, Otsuka software application registration to Cloud Server and patch Acquisition of IEM to Cloud Server|Day 1 Visit at 0, 2, 4 and 6 hours|ITT sample included all participants who had ingested at least 1 dose of placebo-embedded IEM, regardless of whether or not ingestion was detected successfully.|||Minutes||Standard Deviation|Mean
2580526|NCT02404532|Primary|Latency Period Between the Clinical Site-reported Ingestion Time and the Signal Detection of the Ingestion Event by the Patch|All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). The time of each ingestion of an IEM was recorded. The compatible computing device (eg, smartphone) was checked at 30-minute intervals for the presence of a timeline ingestion tile and the time was recorded. To evaluate the latency period between site-reported ingestion time and detection of the ingestion event by the patch which displayed on the MIND1 System compatible computing device (eg, smartphone) as a timeline.|Day 1 Visit at 0, 2, 4 and 6 hours|ITT sample included all participants who had ingested at least 1 dose of placebo-embedded IEM, regardless of whether or not ingestion was detected successfully.|||Minutes||Standard Deviation|Mean
2580527|NCT02404532|Primary|Accuracy of Placebo-embedded IEM Detection by the MIND1 System Measured by the Percentage of Participants With IEM Detection Reported for Each of the 4 Time Points|All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). The time of each ingestion of an IEM was recorded. The compatible computing device (eg, smartphone) was checked at 30-minute intervals for the presence of a timeline ingestion tile and the time was recorded. To measure the accuracy of IEM detection by the MIND1 System using the placebo + IEM by the proportion of participants with IEM detection reported for each of the 4 time points.|Day 1 Visit, at hours 0, 2, 4, 6|ITT sample included all participants who had ingested at least 1 dose of placebo-embedded IEM, regardless of whether or not ingestion was detected successfully.|||Participants|||Count of Participants
2580528|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 - Recommend Product|"Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is I would recommend this product to another parent."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580529|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 - How Productive Caregiver Felt Over Past Week|"Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how productive have you been at work?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580530|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 - How Alert Caregiver Felt Over Past Week|"Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how alert have you felt?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580531|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 - How Rested Caregiver Felt Over Past Week|"Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how rested have you felt?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580532|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 - Caregiver Energy Levels Over Past Week|"Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much energy have you had to engage with your family?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580700|NCT02404025|Secondary|Degree of Exposure to Eltrombopag : Average Daily Dose||Week 104|safety population:The safety population consisted of all subjects who received at least one dose of eltrombopag.|||mg/day||Standard Deviation|Mean
2619596|NCT01962428|Secondary|Platelet Reactivity Index (PRI) Measured by VASP-P||0.5hour,1hour,8hours,24hours after the loading dose of ticagrelor|||||||
2580533|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 - Amount of Time Caregiver Awake|"Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
2580534|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 - Number of Times Caregiver Woke Up|"Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is How many times did you wake up during the night?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||number of times||Standard Deviation|Mean
2580535|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 - Amount of Sleep Caregiver Got Over Past Week|"Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much sleep did you get at night?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
2580536|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 - Child Wanted to Play Over Past Week|"Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much has your child wanted to play?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580537|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 - Child's Mood Upon Waking in Morning|"Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Typically, how would you rate your child's mood when he/she wakes up in the morning?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580538|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 - Child's Mood Over Past Week|"Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, what has your child's mood been?"|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580539|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 - Baby's Skin Feels Soft in Areas Affected by Eczema|"Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin feels soft."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580540|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 - Baby's Skin Looks Healthy in Areas Affected by Eczema|"Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks healthy."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580541|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 - Baby's Skin Looks Smooth in Areas Affected by Eczema|"Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks smooth."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580542|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 - Skin Feels Soft Overall|"Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin feels soft."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580543|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 - Skin Looks Healthy Overall|"Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks healthy."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580544|NCT02404493|Secondary|Caregiver Questionnaire on Day 14 - Skin Looks Smooth Overall|"Questions were answered after 14 days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks smooth."|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580545|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 - How Productive Caregiver Felt Over Past Week|"Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how productive have you been at work?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580546|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 - How Alert Caregiver Felt Over Past Week|"Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how alert have you felt?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580547|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 - How Rested Caregiver Felt Over Past Week|"Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how rested have you felt?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580548|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 - Caregiver Energy Levels Over Past Week|"Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much energy have you had to engage with your family?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580549|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 - Amount of Time Caregiver Awake|"Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
2580550|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 - Number of Times Caregiver Woke Up|"Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is How many times did you wake up during the night?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||number of times||Standard Deviation|Mean
2580551|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 - Amount of Sleep Caregiver Got Over Past Week|"Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much sleep did you get at night?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
2580552|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 - Child Wanted to Play Over Past Week|"Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much has your child wanted to play?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580553|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 - Child's Mood Upon Waking in Morning|"Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Typically, how would you rate your child's mood when he/she wakes up in the morning?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580554|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 - Child's Mood Over Past Week|"Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, what has your child's mood been?"|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580555|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 - Baby's Skin Feels Soft in Areas Affected by Eczema|"Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin feels soft."|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580556|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 - Baby's Skin Looks Healthy in Areas Affected by Eczema|"Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks healthy."|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580557|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 - Baby's Skin Looks Smooth in Areas Affected by Eczema|"Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks smooth."|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580558|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 - Skin Feels Soft Overall|"Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin feels soft."|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580559|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 - Skin Looks Healthy Overall|"Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks healthy."|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580560|NCT02404493|Secondary|Caregiver Questionnaire on Day 7 - Skin Looks Smooth Overall|"Questions were answered after seven days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks smooth."|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580561|NCT02404493|Secondary|Caregiver Questionnaire on Day 3 - Baby's Skin Feels Soft in Areas Affected by Eczema|"Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin feels soft."|3 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580562|NCT02404493|Secondary|Caregiver Questionnaire on Day 3 - Baby's Skin Looks Healthy in Areas Affected by Eczema|"Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks healthy."|3 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580563|NCT02404493|Secondary|Caregiver Questionnaire on Day 3 - Baby's Skin Looks Smooth in Areas Affected by Eczema|"Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks smooth."|3 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580564|NCT02404493|Secondary|Caregiver Questionnaire on Day 3 - Skin Feels Soft Overall|"Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin feels soft."|3 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580565|NCT02404493|Secondary|Caregiver Questionnaire on Day 3 - Skin Looks Healthy Overall|"Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks healthy."|3 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580566|NCT02404493|Secondary|Caregiver Questionnaire on Day 3 - Skin Looks Smooth Overall|"Questions were answered after three days of treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks smooth."|3 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580567|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema|"Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin feels soft."|0 Days - Post-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580568|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema|"Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks healthy."|0 Days - Post-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580569|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Post-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema|"Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks smooth."|0 Days - Post-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580570|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Post-treatment - Skin Feels Soft Overall|"Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin feels soft."|0 Days - Post-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580571|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Healthy Overall|"Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks healthy."|0 Days - Post-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580572|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Post-treatment - Skin Looks Smooth Overall|"Questions were answered after treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks smooth."|0 Days - Post-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580573|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - How Productive Caregiver Felt Over Past Week|"Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how productive have you been at work?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580574|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - How Alert Caregiver Felt Over Past Week|"Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how alert have you felt?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580575|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - How Rested Caregiver Felt Over Past Week|"Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how rested have you felt?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580576|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - Caregiver Energy Levels Over Past Week|"Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much energy have you had to engage with your family?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580577|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Time Caregiver Awake|"Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is If you did wake up during the night, how much time were you awake (on average) before falling back asleep?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
2580578|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - Number of Times Caregiver Woke Up|"Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is How many times did you wake up during the night?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||number of times||Standard Deviation|Mean
2580579|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - Amount of Sleep Caregiver Got Over Past Week|"Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much sleep did you get at night?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
2580580|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - Child Wanted to Play Over Past Week|"Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, how much has your child wanted to play?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580581|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Upon Waking in Morning|"Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Typically, how would you rate your child's mood when he/she wakes up in the morning?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580582|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - Child's Mood Over Past Week|"Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Over this past week, what has your child's mood been?"|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580583|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Feels Soft in Areas Affected by Eczema|"Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin feels soft."|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580701|NCT02404025|Secondary|Duration of CR or PR|Duration for CR or PR will be determined by measuring platelet, reticulocyte, neutrophil and transfusion independence.|Week 104|Number of participants who responded to treatment (7 out of the 10 participants)|||months||Full Range|Median
2622846|NCT01935622|Primary|Peak Aerobic Exercise Capacity|Interval change in peak VO2 measured at cardiopulmonary test|14 days||||||Inter-Quartile Range|Median
2580584|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Healthy in Areas Affected by Eczema|"Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks healthy."|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580585|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - Baby's Skin Looks Smooth in Areas Affected by Eczema|"Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is In the areas affected by eczema, my baby's skin looks smooth."|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580586|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - Skin Feels Soft Overall|"Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin feels soft."|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580587|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Healthy Overall|"Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks healthy."|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580588|NCT02404493|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - Skin Looks Smooth Overall|"Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). The question is Overall, my baby's skin looks smooth."|0 Days - Pre-treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580589|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Child's Sleep a Problem|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580590|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Sleeps During the Day|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
2580591|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Naps Child Takes During the Day|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||number of naps||Standard Deviation|Mean
2580592|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child is Asleep During the Night|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
2580593|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Longest Time Child is Asleep During the Night|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
2580594|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Total Time Child Awake During the Night|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||minutes||Standard Deviation|Mean
2580595|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Number of Times Child Awakes During the Night|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||number of times||Standard Deviation|Mean
2580695|NCT02404025|Secondary|12-lead Electrocardiogram (ECG) as Measure of Safety and Tolerability|Triplicate 12-lead ECGs will be obtained at designated time points during the study using an ECG machine that calculates the heart rate and measures PR, QRS, QT, and QT interval corrected by Fridericia formula (QTcF) intervals.|Baseline, Week 26|safety population: The safety population consisted of all subjects who received at least one dose of eltrombopag.|||Participants|||Count of Participants
2580596|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time for Child to Fall Asleep|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||minutes||Standard Deviation|Mean
2580597|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Difficulty of Bedtime|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580598|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Time Child Usually Put to Bed|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours.minutes||Standard Deviation|Mean
2580599|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Sleeping Arrangement|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580600|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 14 - Responder Role|Questions were answered 14 days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?|14 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580601|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Child's Sleep a Problem|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580602|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Sleeps During the Day|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
2580603|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Naps Child Takes During the Day|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||number of naps||Standard Deviation|Mean
2580604|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child is Asleep During the Night|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
2580605|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Longest Time Child is Asleep During the Night|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
2580606|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Total Time Child Awake During the Night|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||minutes||Standard Deviation|Mean
2580607|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Number of Times Child Awakes During the Night|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||number of times||Standard Deviation|Mean
2580696|NCT02404025|Secondary|Vital Signs (Blood Pressure) as a Measure of Safety and Tolerability|Vital sign measurements : blood pressure|baseline and Week 26|safety set:The safety population consisted of all subjects who received at least one dose of eltrombopag.|||mmHg||Standard Deviation|Mean
2588818|NCT02301390|Secondary|Ventricular Arrhythmic Events|Total number of ventricular arrhythmic events, compared between the 2 treatment arms.|at 24 months||||events|||Number
2580608|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time for Child to Fall Asleep|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||minutes||Standard Deviation|Mean
2580609|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Difficulty of Bedtime|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580610|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Time Child Usually Put to Bed|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours.minutes||Standard Deviation|Mean
2580611|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7- Sleeping Arrangement|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580612|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 7 - Responder Role|Questions were answered seven days after treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?|7 Days|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580613|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Child's Sleep a Problem|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Do you consider your child's sleep a problem? Caregiver answered based on a 6 point system ranged from 'I don't have an opinion' to 'a serious problem'.|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580614|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Sleeps During the Day|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how much total time does your child spend sleeping during the day?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
2580615|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Naps Child Takes During the Day|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On a typical day, how many naps does your child take?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||number of naps||Standard Deviation|Mean
2580616|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child is Asleep During the Night|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, how much total time does your child spend sleeping during the night?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
2580617|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Longest Time Child is Asleep During the Night|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: On average, what is the longest stretch of time that your child is asleep during the night without waking up?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours||Standard Deviation|Mean
2580618|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Total Time Child Awake During the Night|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How much total time during the night is your child typically awake?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||minutes||Standard Deviation|Mean
2580619|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Number of Times Child Awakes During the Night|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How many times does your child typically wake during the night?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||number of times||Standard Deviation|Mean
2580775|NCT02403635|Primary|Time of Peak Concentration (Tmax) of Midazolam||prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26||||h||Full Range|Median
2580620|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time for Child to Fall Asleep|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: How long does it typically take your child to fall asleep?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||minutes||Standard Deviation|Mean
2580621|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Difficulty of Bedtime|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: Typically, how difficult is bedtime for your child? Caregiver answered based on a 5 point system ranging from 'very easy' to 'very difficult'.|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580622|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Time Child Usually Put to Bed|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What time do you usually put your child to bed at night? Time is represented as post meridiem (pm).|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||hours.minutes||Standard Deviation|Mean
2580623|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Sleeping Arrangement|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the sleeping arrangement?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580624|NCT02404493|Secondary|Brief Infant Sleep Questionnaire (BISQ) - Day 0 Pretreatment (Baseline) - Responder Role|Questions were answered before treatment by the participant's caregiver. This survey collects data about sleeping venue, position, hours of sleep at night and during the day, as well as night-wakings and sleep latency. The question is: What is the role of the responder?|0 Days Pretreatment (Baseline)|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||percentage of participants|||Number
2580625|NCT02404493|Secondary|Caregiver's Itch Assessment on Day 14 - Change From Baseline|An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).|Day 0 - Pretreatment (Baseline) to Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2580626|NCT02404493|Secondary|Caregiver's Itch Assessment on Day 7 - Change From Baseline|An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).|Day 0 - Pretreatment (Baseline) to Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2580627|NCT02404493|Secondary|Caregiver's Itch Assessment on Day 3 - Change From Baseline|An assessment of dryness based on the following scale, 0 (don't have an opinion), 1 (none), 2 (a little), 3 (a lot), 4 (all the time).|Day 0 - Pretreatment (Baseline) to Day 3|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2580628|NCT02404493|Secondary|Dryness Scale Score on Day 14 - Change From Baseline|An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).|Day 0 - Pretreatment (Baseline) to Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2580629|NCT02404493|Secondary|Dryness Scale Score on Day 7 - Change From Baseline|An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).|Day 0 - Pretreatment (Baseline) to Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2580630|NCT02404493|Secondary|Dryness Scale Score on Day 3 - Change From Baseline|An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).|Day 0 - Pretreatment (Baseline) to Day 3|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2580631|NCT02404493|Secondary|Dryness Scale Score on Day 1 - Change From Baseline|An assessment of dryness based on a 4 point scale, ranging from 0 (none) to 4 (severe dryness).|Day 0 - Pretreatment (Baseline) to Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2580632|NCT02404493|Secondary|Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Day 0 - Pretreatment (Baseline) to Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2580633|NCT02404493|Secondary|Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Day 0 - Pretreatment (Baseline) to Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2588819|NCT02301390|Secondary|Number of Participant Who Died|Number of subjects that die within 30 days or die by 24 months.|up to 24 months||||Participants|||Count of Participants
2580634|NCT02404493|Secondary|Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Day 0 - Pretreatment (Baseline) to Day 3|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2580635|NCT02404493|Secondary|Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (absent) to 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Day 0 - Pretreatment (Baseline) to Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2580636|NCT02404493|Secondary|Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Day 0 - Pretreatment (Baseline) to Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2580637|NCT02404493|Secondary|Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Day 0 - Pretreatment (Baseline) to Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2580638|NCT02404493|Secondary|Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Day 0 - Pretreatment (Baseline) to Day 3|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2580639|NCT02404493|Secondary|Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (absent) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Day 0 - Pretreatment (Baseline) to Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||units on a scale||Standard Deviation|Mean
2580640|NCT02404493|Secondary|Change From Baseline in Mean Corneometer Measurement 14 Days After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Day 0 - Pretreatment (Baseline) to 14 Days After treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
2580641|NCT02404493|Secondary|Change From Baseline in Mean Corneometer Measurement 7 Days After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Day 0 - Pretreatment (Baseline) to 7 Days After treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
2580642|NCT02404493|Secondary|Change From Baseline in Mean Corneometer Measurement 3 Days After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Day 0 - Pretreatment (Baseline) to 3 Days After treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
2580643|NCT02404493|Secondary|Change From Baseline in Mean Corneometer Measurement 24 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Day 0 - Pretreatment (Baseline) to 24 Hours After treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
2580644|NCT02404493|Primary|Change From Baseline in Mean Corneometer Measurement 12 Hours After Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Day 0 - Pretreatment (Baseline) to 12 Hours After treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
2580645|NCT02404493|Primary|Change From Baseline in Mean Corneometer Measurement Immediately Following Treatment|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated.|Day 0 - Pretreatment (Baseline) to Day 0 - immediately post treatment|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||arbitrary units||Standard Deviation|Mean
2580646|NCT02404389|Secondary|Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at Week 8 for LFX453 Compared to Vehicle Groups Combined|Reduction rate (percent) of Actinic keratosis (AK) lesion count at Week 8 for LFX453 compared to vehicle groups combined|Baseline, Week 8|Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.|||percent change||Standard Deviation|Mean
2580647|NCT02404389|Primary|Reduction Rate (Percent) of Actinic Keratosis (AK) Lesion Count at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined|Reduction rate (percent) of Actinic keratosis (AK) lesion count at 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined|Baseline, Week 20|Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.|||percent change||Standard Deviation|Mean
2580648|NCT02404389|Secondary|Number of Participants That Partial Clearance of Actinic Keratosis (AK) at at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined|Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined|week 8, week 16|Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.|||participants|||Number
2580649|NCT02404389|Secondary|Number of Participants That Had Partial Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined|Partial clearance of Actinic keratosis (AK), the defined as number of patients with at least 75% reduction in the number of AK lesion count compared to baseline, evaluated at 8 weeks after the end of treatment (Week 20 = EOS visit) for LFX453 compared to vehicle groups combined|Week 20|Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.|||participants|||Number
2580650|NCT02404389|Secondary|Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at Week 8 and Week 16 for LFX453 Compared to Vehicle Groups Combined|Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated at week 8 and Week 16 for LFX453 compared to vehicle groups combined|week 8, week 16|Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.|||participants|||Number
2580651|NCT02404389|Primary|Number of Participants That Had Complete Clearance of Actinic Keratosis (AK) at 8 Weeks After the End of Treatment (Week 20) for LFX453 Compared to Vehicle Groups Combined|Complete clearance of Actinic keratosis (AK), defined as the number of patients with a count of zero lesions in the treated area, evaluated 8 weeks after the end of treatment (Week 20) for LFX453 compared to vehicle groups combined|Week 20|Pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. For efficacy end points only there were combined analysis of the 2 vehicle groups. Vehicle groups were analyzed separately for safety and tolerability only.|||participants|||Number
2580652|NCT02404389|Primary|Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 20 Weeks|Number of participants with at least one AE/SAE in the category up to 20 weeks|20 weeks|The safety analysis set included all patients that received any study drug. For Safety & Tolerability only the 2 vehicles have separate analysis.|||participants|||Number
2580653|NCT02404350|Secondary|Count and Percentage of Participants With Dactylitis in the Subset of Patients Who Have Dactylitis at Baseline|The efficacy of secukinumab pooled regimen (150 mg with or without loading regimen, and 300 mg with loading regimen) at Week 16 compared with placebo based on the proportion of patients with dactylitis in the subset of patients who have dactylitis at baseline|16 weeks|Dactylitis subset: The dactylitis subset included all FAS patients who had dactylitis at baseline.|||Participants|||Count of Participants
2580654|NCT02404350|Secondary|Count and Percentage of Patients With Enthesitis in the Subset of Patients Who Had Enthesitis at Baseline|The efficacy of secukinumab pooled regimen (150 mg with or without loading regimen, and 300 mg with loading regimen) at Week 16 compared with placebo based on the proportion of patients with enthesitis in the subset of patients who had enthesitis at baseline|16 weeks|Enthesitis subset: The enthesitis subset included all FAS patients who had enthesitis at baseline.|||Participants|||Count of Participants
2580655|NCT02404350|Secondary|Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing High Sensitivity C-Reactive Protein (hsCRP))|"The improvement on secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo for the disease activity assessed by the changes in Disease Activity Score for 28 joints (DAS28-CRP) (utilizing High sensitivity C-Reactive Protein (hsCRP)) relative to baseline.~Scores range from 0 (no difficulty) to 3 (unable to do)"|16 weeks|Full Analysis Set (FAS)|||scores on a scale||Standard Error|Least Squares Mean
2580656|NCT02404350|Secondary|Change From Baseline in HAQ-DI© Score|The change (within treatment) on secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen), at Week 16 compared with placebo for the disease activity assessed by the changes in The Health Assessment Questionnaire disability index (HAQ-DI) relative to baseline.|16 weeks|Full Analysis Set (FAS)|||scores on a scale||Standard Error|Least Squares Mean
2580657|NCT02404350|Secondary|Count and Percentage of Patients Achieving an ACR50 Response|ACR 50 Response is a measure based on American College of Rheumatology criteria of at least a 50% improvement in the number of tender and swollen joints, and a 50% improvement in at least 3 of the following: the patient's global assessment of disease status; the patient's assessment of pain; the patient's assessment of function measured using the Stanford Health Assessment Questionnaire the physician's global assessment of disease status; serum C-reactive protein levels.|16 weeks|Full Analysis Set (FAS)|||Participants|||Count of Participants
2580658|NCT02404350|Secondary|Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 90 (PASI90) Response|The efficacy of secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo based on the proportion of patients achieving Psoriatic Area and Severity Index 90 (PASI90) response.|16 weeks|Psoriasis subset: The psoriasis subset included all FAS patients who had ≥ 3% of the BSA affected by psoriatic skin involvement at baseline.|||Participants|||Count of Participants
2580659|NCT02404350|Secondary|Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 75 (PASI75) Response|The efficacy of secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo based on the proportion of patients achieving Psoriatic Area and Severity Index 75 (PASI75) response.|Week 16|Psoriasis subset: The psoriasis subset included all FAS patients who had ≥ 3% of the BSA affected by psoriatic skin involvement at baseline.|||Participants|||Count of Participants
2580660|NCT02404350|Secondary|Change From Baseline to Week 24 With Secukinumab Compared With Placebo for Joint/Bone Structural Damage (Using Van Der Heijde Modified Total Sharp Score (mTSS))|PsA modified vdH-mTSS scoring method was used to assess bone erosion & joint space narrowing (JSN) in hands & feet; that included the 2nd through 5th distal interphalangeal (DIP) joints of each hand. Maximum score for erosions was 5 in joints of the hands and 10 in joints of the feet with 0=no erosions, 1=discrete erosion, 2=large erosion not passing the mid-line, and 3=large erosion passing the mid-line. JSN is: 0=normal, 1=asymmetrical or minimal narrowing up to a maximum of 25%, 2 = definite narrowing with loss of up to 50% of the normal space, 3 = definite narrowing with loss of 50-99% of the normal space, and 4 = absence of a joint space. Maximum erosion score is 320 (200 for the hands and 120 for the feet), and the max total JSN score is 208 (160 for the hands and 48 for the feet). Total radiographic score (hands & feet combined) ranges from 0 to 528, where higher scores indicate more articular damage|Baseline, Week 24|The analysis was performed in FAS population with a measurement that could be evaluated. Participants in placebo group, rescued at Week 16 were also extrapolated (i.e. treated as missing at Week 24).|||Mean Sharp Score||Standard Deviation|Mean
2580661|NCT02404350|Primary|Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16|ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement based on tender 78-joint count, swollen 76-joint count and at least 20% improvement in 3 of the following 5 measures: participant's assessment of PsA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, participant's self-assessed disability (Health Assessment Questionnaire Disability Index (HAQ-DI) score), and acute phase reactant evaluated as (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR)).|Week 16|The analysis was performed in Full Analysis Set (FAS) population defined as all randomized participants assigned to study treatment. Following the intent-to-treat principle, participants were analyzed according to treatment assigned at randomization by actual anti-Tumor Necrosis Factor (TNF) status. Missing responses were imputed as non-responders.|||percentage of participants|||Number
2580662|NCT02404285|Other Pre-specified|Change in Quality of Life - Role Social With Daily Use of NAG Compared With Vehicle After 12-weeks.|Change in subjects social response to their acne with daily use of NAG compared with vehicle after 12-weeks. At baseline and each subsequent visit, subjects completed the Acne-QoL form after being given verbal instructions by the study coordinator. The Acne QoL is a validated measure that contains 19 questions referring to the past week, organized into four areas: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives|Baseline until 12 weeks|The average Role-Social score increased from 4.5 to 5.3.|||Score on a scale||Standard Deviation|Mean
2580663|NCT02404285|Other Pre-specified|Change in Quality of Life - Perceived Acne Symptoms With Daily Use of NAG Compared With Vehicle After 12-weeks.|Change in the subjects perception of their acne symptoms with daily use of NAG compared with vehicle after 12-weeks. At baseline and each subsequent visit, subjects completed the Acne-QoL form after being given verbal instructions by the study coordinator. The Acne QoL is a validated measure that contains 19 questions referring to the past week, organized into four areas: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives|Baseline until 12 weeks||||Score on a scale||Standard Deviation|Mean
2580664|NCT02404285|Other Pre-specified|Change in Quality of Life - Role Emotional With Daily Use of NAG Compared With Vehicle After 12-weeks.|Change in Role-Emotional scores with daily use of NAG compared with vehicle after 12-weeks. At baseline and each subsequent visit, subjects completed the Acne-QoL form after being given verbal instructions by the study coordinator. The Acne QoL is a validated measure that contains 19 questions referring to the past week, organized into four areas: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives|Baseline until 12 weeks||||Score on a scale||Standard Deviation|Mean
2580697|NCT02404025|Secondary|Number of Participants With Adverse Events|Adverse events will be collected from the start of study treatment until the approval.|though study completion , approximately 2 years|safety population:The safety population consisted of all subjects who received at least one dose of eltrombopag.|||Participants|||Count of Participants
2580698|NCT02404025|Secondary|Degree of Exposure to Eltrombopag : Days on Study||Week 104|safety population:The safety population consisted of all subjects who received at least one dose of eltrombopag.|||days||Standard Deviation|Mean
2580665|NCT02404285|Other Pre-specified|Change in Quality of Life - Self Perception With Daily Use of NAG Compared With Vehicle After 12-weeks.|Change in Self Perception scores with daily use of NAG compared with vehicle after 12-weeks. The Acne Quality of Life (QoL) Questionnaire Form was used to determine the practical improvements in quality of life. The Acne-QoL form is a validated measure that contains 19 questions referring to the past week, organized into four area: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives.|Baseline until 12 weeks|The average self-perception score for NAG users increased from 4.1 to 5.0.|||Score on a scale||Standard Deviation|Mean
2580666|NCT02404285|Secondary|Change in Itching With Daily Use of NAG Compared With Vehicle After 12-weeks.|Change in Itching scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).|Baseline until 12 weeks|NAG application resulted in Itching scores of 0.1 to 0.0 for the Acne Gel and from 0.2 to 0.0 for the Vehicle Control.|||Average score on a scale||Standard Deviation|Mean
2580667|NCT02404285|Secondary|Change in Pain With Daily Use of NAG Compared With Vehicle After 12-weeks.|Change in Pain scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).|Baseline until 12 weeks|NAG and vehicle application yielded average pain scores decreasing from 0.1 to 0.0.|||Average score on a scale||Standard Deviation|Mean
2580668|NCT02404285|Secondary|Change in Edema With Daily Use of NAG Compared With Vehicle After 12-weeks.|Change in Edema scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).|Baseline until 12 weeks|NAG application resulted in average scores decreasing from 0.1 to 0.0 for the Acne Gel, and from 0.2 to 0.1 for the Vehicle Control.|||Average score on a scale||Standard Deviation|Mean
2580669|NCT02404285|Secondary|Change in Erosion With Daily Use of NAG Compared With Vehicle After 12-weeks.|Change in Erosion scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).|Baseline until 12 weeks|NAG application resulted in average scores remaining between 0.1 and 0.0 for all time points for both NAG and Vehicle groups.|||Average score on a scale||Standard Deviation|Mean
2580670|NCT02404285|Secondary|Change in Burning/Stinging With Daily Use of NAG Compared With Vehicle After 12-weeks.|Change in Burning/Stinging scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).|Baseline until 12 weeks|NAG application resulted in average Burning or Stinging scores increasing from 0.0 to 0.1 over 12 weeks, compared to a decrease in Vehicle Control from 0.1 to 0.0.|||Average score on a scale||Standard Deviation|Mean
2580671|NCT02404285|Secondary|Change in Dryness With Daily Use of NAG Compared With Vehicle After 12-weeks.|Change in Dryness score with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).|Baseline until 12 weeks|NAG application yielded Dryness average scores decreasing from 0.3 to 0.1 over 12 weeks compared to no decrease in the Vehicle control (0.3 to 0.3).|||Average score on a scale||Standard Deviation|Mean
2580672|NCT02404285|Secondary|Change in Erythema Scores With Daily Use of NAG Compared With Vehicle After 12-weeks.|Change in Erythema (measure of redness) scores with daily use of NAG compared with vehicle after 12-weeks.Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).|Baseline until 12 weeks|The Next Science Acne Gel had average erythema score decreasing from 0.5 to 0.3 for the Acne Gel and to 0.5 to 0.4 for the Vehicle Control (not shown).|||Average Score on a scale||Standard Deviation|Mean
2580673|NCT02404285|Secondary|Final Investigator Global Assessment Score With Daily Use of NAG Compared With Vehicle After 12-weeks.|Change in Investigator Global Assessment (IGA) score (0-5) with daily use of NAG compared with vehicle after 12-weeks. IGA score is worse at 5, with improvement at lower scores (best at 0).|Baseline until 12 weeks||||Score on a scale||Standard Error|Mean
2580674|NCT02404285|Secondary|Percent Change in Non-Inflammatory Lesion Counts After 12 Weeks of Treatment.|Percent Change in Number of Non-inflammatory lesions (open and closed comedones) were counted after 12 weeks of either Vehicle of NAG treatment|12 weeks||||% Change Non-inflammatory lesion count||Standard Deviation|Mean
2580675|NCT02404285|Primary|Change in Inflammatory Lesions With Daily Use of NAG Compared With Vehicle After 12-weeks of Use.|Percent change in number of Inflammatory lesions with daily use of NAG compared with vehicle after 12-weeks of use.|Baseline until 12 weeks|Subjects who completes all visits.|||% change of inflammatory lesions count||Standard Error|Mean
2580676|NCT02404220|Secondary|Percentage of Participants With Overall Response at the End of Induction|"Overall response included CR, CRi, and PR. CR required all of the following:~No circulating blasts or extramedullary disease (no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement).~TLH and < 5% blasts in bone marrow aspirate.~ANC > 1000/μL.~Platelets > 100,000/μL.~CRi required all criteria for CR except platelet count and/or ANC:~Platelets ≤ 100,000/μL and/or ANC is ≤ 1000/μL~PR required all criteria for CR except for bone marrow blasts:~bone marrow may contain ≥ 5% but less than 25% blast morphology"|End of Induction (Cycle 2, Day 28)|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2580677|NCT02404220|Secondary|Percentage of Participants With Partial Response (PR) at the End of Induction|"PR required all of the following:~No circulating blasts or extramedullary disease (no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement).~TLH and bone marrow may contain ≥ 5% but less than 25% blast morphology.~ANC > 1000/μL.~Platelets > 100,000/μL."|End of Induction (Cycle 2, Day 28)|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2582705|NCT02376166|Secondary|Increased Frequency of Bowel Movements|Quality of LIfe as measured by a modified RAND 36-Item Health Survey. Ist reported outcome - Number of episodes of Increased frequency of bowel movements|6 months||||episodes|||Number
2580678|NCT02404220|Secondary|Percentage of Participants With Overall Remission at the End of Induction|"Assessment of clinical response was made according to NCCN guidelines on ALL Version 2, 2016. Overall remission included CR and complete remission with incomplete hematologic recovery (CRi). CR required all of the following:~No circulating blasts or extramedullary disease (no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement).~TLH and < 5% blasts in bone marrow aspirate.~ANC > 1000/μL.~Platelets > 100,000/μL.~CRi required all criteria for CR except platelet count and/or ANC:~Platelets ≤ 100,000/μL and/or ANC is ≤ 1000/μL"|End of Induction (Cycle 2, Day 28)|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2580679|NCT02404220|Secondary|Percentage of Participants With Complete Remission (CR) at the End of Induction|"Assessment of clinical response was made according to National Comprehensive Cancer Network (NCCN) guidelines on acute lymphoblastic leukemia (ALL) Version 2, 2016. CR required all of the following:~No circulating blasts or extramedullary disease (no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement).~Trilineage hematopoiesis (TLH) and < 5% blasts in bone marrow aspirate.~ANC > 1000/μL.~Platelets > 100,000/μL."|End of Induction (Cycle 2, Day 28)|The Full Analysis Set included all participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
2580680|NCT02404220|Primary|Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)|"The occurrence of any of the following toxicities during Lead-in/Cycle 1 (Day -7 through Day 28) was considered a DLT if judged by the investigator to be possibly, probably, or definitely related to the administration of any drug in the treatment regimen (ENTO, VCR, DEX, institutional standard CNS prophylaxis):~Grade 4 (or higher) non-hematologic toxicity~Grade 3 non-hematologic toxicity lasting ≥ 7 days despite optimal supportive care~Any Grade 3 non-hematologic laboratory value if:~Medical intervention was required to treat, or~The abnormality led to hospitalization, or~The abnormality persisted for > 1 week~Grade 4 Neutropenia (absolute neutrophil count [ANC] < 500 /μL) persistent for greater than 14 days or associated with febrile neutropenia~Grade 4 thrombocytopenia (platelets < 25,000/μL) persisting for greater than 14 days (or greater than 25,000 /μL, but requiring prophylactic platelet transfusion to maintain this level)"|ENTO Lead-in and Cycle 1 (Day -7 through Day 28)|DLT Analysis Set included all participant in the Safety Analysis Set (all participants who received at least 1 dose of study treatment) who met at least one of the following criteria: received at least 21 days of ENTO, > 50% of planned total dose of VCR and DEX, or experienced a DLT during the DLT assessment window.|||percentage of participants|||Number
2580681|NCT02404168|Primary|Cmax|pharmacokinetic rate (ng/ml). Pharmacokinetic (PK) blood levels will be drawn at the schedule times: immediately prior to lamotrigine administration, then after drug administration at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, and 12.0 hr.|0-12hr||||ng/ml||Standard Error|Mean
2580682|NCT02404168|Primary|AUC|pharmacokinetic exposure (ng*hr/ml). Pharmacokinetic (PK) blood levels will be drawn at the schedule times: immediately prior to lamotrigine administration, then after drug administration at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, and 12.0 hr.|0-12hr||||ng*hr/ml||Standard Error|Mean
2580683|NCT02404103|Primary|Impulse Oscillometry (IOS) Resistance 5 (R5)|Resistance of the respiratory system at 5 Hz is a measure of total airway resistance. Elevated value is indicative of respiratory dysfunction.|initial visit and six week followup|Only data for subjects who completed study are presented.|||cmH2O(L/s)||Standard Deviation|Mean
2580684|NCT02404103|Primary|Spirometry Forced Expiratory Flow 25-75% (FEF 25-75%)|Indirectly assess small airway function.|baseline and six week followup|Those subjects that completed the study protocol.|||% of predicted||Standard Deviation|Mean
2580685|NCT02404103|Primary|Impulse Oscillometry (IOS) Area of Reactance (AX) After Flunisolide Treatment|A composite measure of small airway dysfunction. A reduction in IOS scores indicate an improvement.|Baseline and six week followup|Those subjects that completed the study protocol.|||cmH2O/L||Standard Deviation|Mean
2580686|NCT02404103|Primary|Spirometry Forced Expiratory Volume 1 (FEV1) After Flunisolide|the most used outcome in respiratory studies|Before and after treatment at baseline and six week followup|Those subjects that completed the study protocol.|||% of predicted||Standard Deviation|Mean
2580687|NCT02404025|Secondary|Vital Signs (Pulse Rate) as a Measure of Safety and Tolerability|Vital sign measurements : pulse rate.|baseline and Week 26|safety set:The safety population consisted of all subjects who received at least one dose of eltrombopag.|||beats/min||Standard Deviation|Mean
2580688|NCT02404025|Secondary|Vital Signs (Temperature) as a Measure of Safety and Tolerability|Vital sign measurements : temperature|baseline and Week 26|safety set:The safety population consisted of all subjects who received at least one dose of eltrombopag.|||°C||Standard Deviation|Mean
2580689|NCT02404025|Secondary|Composite of Laboratory Parameters Assessment as a Safety Measure.|The laboratory test values (hematological /biochemical examinations) were calculated at each time point of evaluation.|Baseline, Week 26|safety set:The safety population consisted of all subjects who received at least one dose of eltrombopag.|||umol/L||Standard Deviation|Mean
2580690|NCT02404025|Secondary|Composite of Laboratory Parameters Assessment as a Safety Measure (Alcaline Phosphatase and Aspartate Amino Transferase) .|The laboratory test values (Alcaline Phosphatase and Aspartate Amino Transferase) were calculated at each time point of evaluation.|Baseline, Week 26|safety set:The safety population consisted of all subjects who received at least one dose of eltrombopag.|||IU/L||Standard Deviation|Mean
2580691|NCT02404025|Secondary|Composite of Laboratory Parameters Assessment as a Safety Measure (Lymphocytes and Neutrophils).|The laboratory test values (lymphocytes and neutrophils) were calculated at each time point of evaluation.|Baseline, Week 26|safety set:The safety population consisted of all subjects who received at least one dose of eltrombopag.|||Gi/L||Standard Deviation|Mean
2580692|NCT02404025|Secondary|Composite of Laboratory Parameters Assessment as a Safety Measure (Haemoglobin and Albumin).|The laboratory test values (haemoglobin and albumin) were calculated at each time point of evaluation.|Baseline, Week 26|safety set:The safety population consisted of all subjects who received at least one dose of eltrombopag.|||g/L||Standard Deviation|Mean
2580693|NCT02404025|Secondary|The Concentration After 4 Hours of Dose of Eltrombopag 75 mg|Blood sample will be collected at 4 hours after repeat (14 days) dose of eltrombopag 75 mg|day 15|pharmacokinetic population: The PK population was defined as all subjects whose PK samples were collected and measured.|||ng/mL||Standard Deviation|Mean
2625539|NCT01911169|Secondary|Change in Interferon Signature|This outcome was not measured as planned|from zero to sixteen weeks|||||||
2580702|NCT02404025|Secondary|Time to Onset of CR and PR|The time to onset of CR and PR will be determined by measuring platelet, reticulocyte, neutrophil and transfusion independence.|Week 26|Full analysis set; population obtained by excluding subjects: Eltrombopag was never administered to the subject during the study, subject had no baseline data: platelet count, hemoglobin, neutrophil count, and transfusion,subject had no data after the start of rabbit ATG therapy: platelet count, hemoglobin, neutrophil count, and transfusion.|||months||Full Range|Median
2580703|NCT02404025|Secondary|Duration of Hospitalization|Duration of hospitalization is the time period from the administration of ATG up to discharge.|Week 26|Full analysis set; population obtained by excluding subjects: Eltrombopag was never administered to the subject during the study, subject had no baseline data: platelet count, hemoglobin, neutrophil count, and transfusion,subject had no data after the start of rabbit ATG therapy: platelet count, hemoglobin, neutrophil count, and transfusion.|||days||Full Range|Median
2580704|NCT02404025|Secondary|The Proportion of Subjects Whose Transfusion Unit (or Volume) Are Decreased or Who Became Transfusion (Platelet, RBC) Independent|The proportions of the subjects for whom the amount of blood transfusion (platelets and RBC) decreased or the proportions of the subjects for whom blood transfusion (platelets and RBC) became unnecessary. Platelet transfusion will be done if the platelet count is less than 10×10^9/L with significant bleeding tendency or the platelet count is less than 20×10^9/L with pyrexia. RBC transfusion will be done to keep the hemoglobin concentration at over 7 g/dL or in the presence of clinical symptoms such as dyspnea.|Week 26|Full analysis set; population obtained by excluding subjects: Eltrombopag was never administered to the subject during the study, subject had no baseline data: platelet count, hemoglobin, neutrophil count, and transfusion,subject had no data after the start of rabbit ATG therapy: platelet count, hemoglobin, neutrophil count, and transfusion.|||Participants|||Count of Participants
2580705|NCT02404025|Secondary|Volume of Platelet and RBC Transfusions|Platelet or RBC transfusions will be based on physician's subjective judgement. Platelet transfusion will be done if the platelet count is less than 10×10^9/L with significant bleeding tendency or the platelet count is less than 20×10^9/L with pyrexia. RBC transfusion will be done to keep the hemoglobin concentration at over 7 g/dL or in the presence of clinical symptoms such as dyspnea.|Baseline, Week 26|Full analysis set, patients who were transfusion dependent|||mL||Standard Deviation|Mean
2580706|NCT02404025|Secondary|Frequency of Platelet and Red Blood Cells (RBC) Transfusions|RBC transfusion dependency defined as at least one RBC transfusion within 8 weeks prior to D1. Platelet or RBC transfusions will be based on physician's subjective judgement. Platelet transfusion will be done if the platelet count is less than 10×10^9/liter (L) with significant bleeding tendency or the platelet count is less than 20×10^9/L with pyrexia. RBC transfusion will be done to keep the hemoglobin concentration at over 7 g/dL or in the presence of clinical symptoms such as dyspnea.|Baseline, Week 26|full analysis set, participants who were transfusion dependant|||mean of transfusions number||Standard Deviation|Mean
2580707|NCT02404025|Secondary|Changes in Hematology Parameters in the Absence of Platelet Transfusion|The change in hematology values from baseline for platelets, neutrophils and reticulocytes were evaluated.|Week 26 and week 104|Full analysis set; population obtained by excluding subjects: Eltrombopag was never administered to the subject during the study, subject had no baseline data: platelet count, hemoglobin, neutrophil count, and transfusion,subject had no data after the start of rabbit ATG therapy: platelet count, hemoglobin, neutrophil count, and transfusion.|||Gi/L||Standard Deviation|Mean
2580708|NCT02404025|Secondary|Changes in Hematology Parameters (Haemoglobin) in the Absence of Platelet Transfusion|The change in hematology values ( haemoglobin) were evaluated.|Week 26 and week 104|Full analysis set; population obtained by excluding subjects: Eltrombopag was never administered to the subject during the study, subject had no baseline data: platelet count, hemoglobin, neutrophil count, and transfusion,subject had no data after the start of rabbit ATG therapy: platelet count, hemoglobin, neutrophil count, and transfusion.|||g/L||Standard Deviation|Mean
2580709|NCT02404025|Secondary|CR Rate Based on the Criteria Used in NIH 12-H-0150 Study at 6 Months|CR criteria used in NIH 12-H-150 study is as follows: Hemoglobin >10 gram (g)/ deciliter (dL), and Absolute neutrophil count (ANC) >1,000/microliter, and Platelets >100,000/microliter.|Week 26|Full analysis set; population obtained by excluding subjects: Eltrombopag was never administered to the subject during the study, subject had no baseline data: platelet count, hemoglobin, neutrophil count, and transfusion,subject had no data after the start of rabbit ATG therapy: platelet count, hemoglobin, neutrophil count, and transfusion.|||Participants|||Count of Participants
2580710|NCT02404025|Secondary|Complete Response (CR), and Partial Response (PR) Rate at 3 Months|CR and PR will be calculated after 3 months of eltrombopag administration by measuring platelet, reticulocyte, neutrophil and transfusion independence.|Week 14|Full analysis set; population obtained by excluding subjects: Eltrombopag was never administered to the subject during the study, subject had no baseline data: platelet count, hemoglobin, neutrophil count, and transfusion,subject had no data after the start of rabbit ATG therapy: platelet count, hemoglobin, neutrophil count, and transfusion.|||Participants|||Count of Participants
2580711|NCT02404025|Secondary|ORR at 3 Months|ORR will be calculated after 3 months of eltrombopag administration by measuring platelet, reticulocyte, neutrophil and transfusion independence.|Week 14|Full analysis set; population obtained by excluding subjects: Eltrombopag was never administered to the subject during the study, subject had no baseline data: platelet count, hemoglobin, neutrophil count, and transfusion,subject had no data after the start of rabbit ATG therapy: platelet count, hemoglobin, neutrophil count, and transfusion.|||Participants|||Count of Participants
2580712|NCT02404025|Primary|ORR at 6 Months: Overall Response Rate (ORR) Defined as the Number of Participants Who Met the Criteria of Either Complete Response (CR) or Partial Response (PR) at Week 26|ORR will be calculated after 6 months of eltrombopag administration by measuring platelet, reticulocyte, neutrophil and transfusion independence. ORR includes Complete Response (CR) and Partial Response (PR) Rate.|Week 26|Full analysis set; population obtained by excluding subjects: Eltrombopag was never administered to the subject during the study, subject had no baseline data: platelet count, hemoglobin, neutrophil count, and transfusion,subject had no data after the start of rabbit ATG therapy: platelet count, hemoglobin, neutrophil count, and transfusion.|||Participants|||Count of Participants
2580776|NCT02403635|Primary|Peak Plasma Concentration (Cmax) of Midazolam||prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2580713|NCT02403999|Secondary|Change From Baseline in Overall Dry Skin [ODS] Score at Day 14 (Visual Assessment of Skin)|The changes in participants' skin condition was assessed using the ODS score: where 0= Absent; 1= Faint scaling, faint roughness and dull appearance; 2= Small scales in combination with a few larger scales, slight roughness, whitish appearance; 3= Small and larger scales uniformly distributed, definite roughness, possibly slight redness and possibly a few superficial cracks; 4= Dominated by large scales, advanced roughness, redness present, eczematous changes and cracks.|At baseline and day 14|Safety population (overall): included all the participants who received at least one of the test product. Participants were further divided in two age strata Age <12 months and Age ≥ 12 months.|||Score on scale||Standard Deviation|Mean
2580714|NCT02403999|Primary|Tolerability Assessment of Test Products|The tolerability of the test products under normal conditions of use was assessed by the paediatrician using a 5 point scale: where score 1= very good; 2= good; 3= acceptable; 4= poor and 5= very poor.|At Day 14|Safety population (overall): included all the participants who received at least one of the test product. Participants were further divided in two age strata Age <12 months and Age ≥ 12 months.|||Participants|||Count of Participants
2580715|NCT02403986|Primary|Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Investigator|"Investigator assessment at follow-up visits of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale (GAIS).~GAIS is a 5-graded scale: worse; no change; improved; much improved; or very much improved.~A clinically significant improvement was defined as a score of improved; much improved; or very much improved."|Baseline, 1 Month, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 18 Months|At 1 Month after initial treatment, there were 24 participants in Group A and 25 participants in Group B. (26 and 27 respectively randomized, as reported in Participant Flow.)|||% improved participants||95% Confidence Interval|Number
2580716|NCT02403986|Primary|Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Subject|"Subject assessment at follow-up visits of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale (GAIS).~GAIS is a 5-graded scale: worse; no change; improved; much improved; or very much improved.~A clinically significant improvement was defined as a score of improved; much improved; or very much improved."|Baseline, 1 Month, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 18 Months|At 1 Month after initial treatment, there were 24 participants in Group A and 25 participants in Group B. (26 and 27 respectively randomized, as reported in Participant Flow.)|||% improved participants||95% Confidence Interval|Number
2580717|NCT02403895|Secondary|Estimated Pharmacokinetic Exposure to AZD2014 Through the Use of Population PK Modelling|Group B patients: PK parameters for AZD2014 estimated from a sparse PK sampling regimen and use of population PK modelling techniques (may be reported outside the clinical study report (CSR))|Assessment at multiple timepoints in Group B patients between study day 1 and day 3. Samples will be taken at 3 points on day 1 and at predose and at a further 2 points on day 3|The exposure of AZD2014 could not be estimated using a population PK model because there were insufficient subjects with intensive PK sampling (n=2) to develop at population PK model||||||
2580718|NCT02403895|Secondary|Evaluate the Effect of the Combination of AZD2014 and Paclitaxel on Pharmacokinetics Assessment of Cmax|To determine the effect of co-administration of paclitaxel on the PK of oral AZD2014 and the effect of co administration of oral AZD2014 on the PK of paclitaxel (Group A) by: PK parameters for each in the presence and absence of the other by intensive PK sampling and NCA techniques.|Assessment at multiple timepoints in Group A patients. Samples will be taken at pre-dose and at 10 further timepoints on day 1 and at pre-dose and 9 further timepoints on days 3 and 8|Data insufficient for full PK parameter evaluation or comparisons made between AZD2014 and paclitaxel|||ng/mL||Full Range|Mean
2580719|NCT02403895|Secondary|Progression Free Survival: Median Number of Days Between Start of Dosing Until Objective Disease Progression Through Measurement of Tumour Lesion Sizes|Assessment of the duration of progression free survival through assessment of tumour lesions by RECIST 1.1 criteria|From date of first dose until documented progression or end of life (Approx 3 months)||||Days||95% Confidence Interval|Median
2580720|NCT02403895|Secondary|Change in Tumour Size: Median Percentage Change in Tumour Size in mm by Measurement of Tumour Lesion Sizes|Assessment of the degree of tumour response through measurement of the change in tumour lesion sizes|From baseline until documented progression (Approx 3 months)||||% change||Full Range|Median
2580721|NCT02403895|Secondary|Disease Control Rate: Percentage of Patients Who Achieve Partial Response, Complete Response or Stable Disease Through Assessment of Tumour Lesion Sizes|Assessment of the disease control rate, percentage of patients who experience a response through assessment of tumour lesions by RECIST 1.1 criteria|From first dose until documented progression and at least 6 weeks after the start of treatment for assessment of Stable Disease - Assessed at 6, 13 and 20 Weeks||||Percentage of patients||80% Confidence Interval|Number
2580722|NCT02403895|Secondary|Duration of Response: Median Number of Days From the Date of First Documented Response Until the Date of Documented Progression Through Measurement of Tumour Lesion Sizes|Assessment of the duration of tumour response through assessment of tumour lesions by RECIST 1.1 criteria. Response is defined as the point at which the criteria for Partial Response (PR) was met) >=30% decrease in sum of target lesion longest diameter. Progression is defined as the point at which the criteria for Progressive Disease (PD) was met >=20% increase in sum of target lesion longest diameter, or until end of life.|From date of first documented response until documented progression or end of life in the absence of progression (Approx 3 months)|No participant responded therefore no duration of response data to report||||||
2580723|NCT02403895|Secondary|Best Objective Response: Number of Patients Who Experienced a Best Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not-Evaluable (NE), Through Measurement of Tumour Lesion Sizes.|Per Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed through imaging (CT or MRI scan) or clinical examination; Complete Response (CR): Disappearance of all target lesions; Partial Response (PR) >=30% decrease in sum of target lesion longest diameter; Progressive Disease >=20% increase in sum of target lesion longest diameter; Stable Disease (SD) increase or decrease amounting to neither PR or PD. Overall tumour assessment based on quantitative assessment of target lesions and qualitative assessment of non-target lesions in line with RECIST criteria.|From Baseline until Disease Progression (Approx 3 months)||||Count of Participants|||Number
2600636|NCT02159950|Secondary|Change in PSA Response|PSA doubling time, PSA slope|Baseline to up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.||||||
2580724|NCT02403895|Secondary|Overall Survival: Median Number of Days Between the First Dose and End of Life Due to Any Cause|Assessment of the duration of overall survival in weeks through direct patient follow-up. Any patient not known to have died at the time of analysis censored at the last recorded date the patient was known to be alive|From first dose until end of life (Approx 9 months)||||Days||95% Confidence Interval|Median
2580725|NCT02403895|Secondary|Number of Patients Who Experienced at Least One Adverse Event (AE) or Serious Adverse Event (SAE)|"The safety and tolerability of AZD2014 with weekly paclitaxel as assessed with the collection of Adverse Events and Serious Adverse Events as reported during clinic visits. In addition, clinical assessments were made throughout the on treatment period including blood test for chemistry, haematology, and blood clotting. In addition to clinical observations such as vital signs, and cardiac function through the use of ECG.~Any findings from the above assessments which were considered to be abnornal and clinically significant by the doctor were reported as (AEs or SAEs)."|Informed consent until end of safety follow up (Approx 10 months if all treatment cycles are completed)||||Count of Participants|||Number
2580726|NCT02403895|Primary|Percentage of Patients Who Have a Partial Response or Complete Response Through Measurement of Tumour Lesion Sizes|Calculation of the percentage of patient who have a Complete Response or Partial Response to treatment which is confirmed by a repeat assessment 4 weeks later|From first dose until disease progression (Approximately 3 months)|Analysis Set: Evaluable for efficacy set. All dosed patients with a baseline tumour assessment|||Percentage||90% Confidence Interval|Number
2580727|NCT02403830|Secondary|AUC of Ticagrelor Plasma Levels|The area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC) was calculated based on ticagrelor plasma levels|6 hours||||ng*hr/mL||Full Range|Geometric Mean
2580728|NCT02403830|Secondary|Platelet Reactivity Measured by VASP|Platelet reactivity measured by VASP 2 hours after ticagrelor loading dose and reported as platelet reactivity index (PRI)|2 hours||||PRI||95% Confidence Interval|Least Squares Mean
2580729|NCT02403830|Primary|Platelet Reactivity Measured by VerifyNow P2Y12|Platelet reactivity measured by VerifyNow P2Y12 2 hours after ticagrelor loading dose and reported as P2Y12 reaction units (PRU)|2 hours||||PRU||95% Confidence Interval|Least Squares Mean
2580730|NCT02403817|Primary|Change in Saccadic Eye Movements at 8 Weeks|This task uses an eyetracker to measure the change in the speed and accuracy of a participant's saccadic eye movements in response to various stimuli as a result of the intervention. Measure is accuracy of first saccade in an anti-saccade task.|end of Week 8|Because of technical difficulties we have data for only part of the sample.|||Percent Correct Direction||Standard Deviation|Mean
2580731|NCT02403817|Primary|Change in Spatial Attention at 8 Weeks|This behavioral task assesses the change in the participant's ability to rapidly and accurately shift visual attention to different spatial locations as a result of the intervention.|end of Week 8|All participants who completed 8 weeks of training were analyzed.|||Percent Correct||Standard Deviation|Mean
2580732|NCT02403817|Primary|Saccadic Eye Movements Baseline|This task uses an eyetracker to measure the baseline speed and accuracy of a participant's saccadic eye movements in response to various stimuli. Measure is accuracy of first saccade in the anti-saccade task.|Pre-intervention|Because of technical difficulties we have only partial data for this measure.|||percent correct direction||Standard Deviation|Mean
2580733|NCT02403817|Primary|Spatial Attention Baseline|This behavioral task assesses the participant's baseline ability to rapidly and accurately shift visual attention to different spatial locations. This task also reveals whether a participant becomes overly-focused ('stuck') at specific locations.|Pre-intervention|All participants who completed the 8 weeks of game-based training were analyzed.|||Percent Correct||Standard Deviation|Mean
2580734|NCT02403778|Secondary|Unresectable Stage III and STAGE IV|Subjects will be followed for evidence of disease progression.|Up to 2 years from the time of study enrollment for each patient.||||Days||Full Range|Median
2580735|NCT02403778|Secondary|Changes in the Frequency of Tumor-specific T Cell Responses|Changes in the frequency of tumor-specific T cell responses attributable to the addition of VESANOID to standard ipilimumab therapy will be determined by the frequency of Interferons (IFN)-gamma producing cells after stimulation with melanoma antigens.|4 weeks prior to start, Midway thru and at least 30 days post final infusion||||Percentage of Activated CD8+ T cells||Standard Deviation|Mean
2580736|NCT02403778|Primary|MDSC Suppressive Function|MDSC suppressive function in peripheral blood will be measured through the activation and proliferation of T cells in the presence of isolated MDSCs. Functional assays will be performed to assess the ability of isolated MDSCs to suppress T-cell responses.|4 weeks prior to start, Midway thru and at least 30 days post final infusion||||Percentage of Proliferating T Cells||Standard Deviation|Mean
2580737|NCT02403778|Primary|MDSC Frequency|The frequency of circulating MDSCs will be measured by flow cytometry and calculated as a percentage of the total myeloid cell population. This outcome will be measured at the final study blood draw between 84 and 130 days following the first treatment.|84 and 130 days following the first treatment||||% MDSCs of Myeloid Cells||Standard Error|Mean
2580738|NCT02403778|Primary|Number of Adverse Events|Safety and tolerability of ipilimumab and VESANOID combination therapy in advanced melanoma patients will be established using the Bayesian approach.|Up to 2 years from the time of study enrollment for each patient.||||Number of events in treatment group|||Number
2580739|NCT02403674|Secondary|Plasma Concentration of Doravirine at Week 48|Plasma samples were collected for analysis of doravirine concentration at Week 48. A total of 2 samples were collected: 1 prior to dosing and 1 collected between 0.5 and 2 hours post-dose.|0 hours post-dose and 2 hours post-dose on Week 48|The analysis population consists of all randomized participants in the MK-1439A arm who received ≥1 dose of study drug and had doravirine concentration data available.|||nM||Standard Deviation|Mean
2580740|NCT02403674|Secondary|Percentage of Participants With HIV-1 RNA BLoQ at Week 96|The percentage of participants in each arm with HIV-1 RNA levels BLoQ of 40 copies/mL and target not detected at Week 96 will be determined. Plasma HIV RNA levels will be quantified with the Abbott RealTime HIV-1 Assay. Data will be handled as observed.|Week 48|The analysis population will consist of all randomized participants who receive ≥1 dose of study medication and have baseline HIV-1 RNA data available. The current results are based on the first 48 weeks of the study; Week 96 results will be provided in a future report.||||||
2601688|NCT02150837|Secondary|Abdominal Circumference|Abdominal circumference expressed as an absolute change from baseline.|24 weeks||||Inches||Standard Deviation|Mean
2580741|NCT02403674|Secondary|Percentage of Participants With HIV-1 RNA Below the Limit of Quantification (BLoQ) at Week 48|The percentage of participants in each arm with HIV-1 RNA levels BLoQ of 40 copies/mL and target not detected at Week 48 was determined. Plasma HIV RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled as observed.|Week 48|The analysis population consists of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.|||Percentage of Participants|||Number
2580742|NCT02403674|Secondary|Change From Baseline in Fasting HDL-C at Week 48|The mean percent change from baseline in fasting (fast duration of ≥8 hours) HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.|Baseline (Day 1) and Week 48|The analysis population consists of all randomized participants who had baseline HDL-C data available as well as ≥1 HDL-C measurement after initiating study treatment.|||Percent Change from Baseline||95% Confidence Interval|Mean
2580743|NCT02403674|Secondary|Change From Baseline in Fasting Triglycerides at Week 48|The mean percent change from baseline in fasting (fast duration of ≥8 hours) triglycerides levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.|Baseline (Day 1) and Week 48|The analysis population consists of all randomized participants who had baseline triglyceride data available as well as ≥1 triglyceride measurement after initiating study treatment.|||Percent Change from Baseline||95% Confidence Interval|Mean
2580744|NCT02403674|Secondary|Change From Baseline in Fasting Cholesterol at Week 48|The mean percent change from baseline in fasting (fast duration of ≥8 hours) cholesterol levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.|Baseline (Day 1) and Week 48|The analysis population consists of all randomized participants who had baseline cholesterol data available as well as ≥1 cholesterol measurement after initiating study treatment.|||Percent Change from Baseline||95% Confidence Interval|Mean
2580745|NCT02403674|Secondary|Change From Baseline in Fasting Non-HDL-C at Week 48|The mean percent change from baseline in fasting (fast duration of ≥8 hours) non-HDL-C levels at Week 48 was determined for each arm. The LOCF approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.|Baseline (Day 1) and Week 48|The analysis population consists of all randomized participants who had baseline non-HDL-C data available as well as ≥1 non-HDL-C measurement after initiating study treatment.|||Percent Change from Baseline||95% Confidence Interval|Mean
2580746|NCT02403674|Secondary|Change From Baseline in Fasting LDL-C at Week 48|The mean percent change from baseline in fasting (fast duration of ≥8 hours) LDL-C levels at Week 48 was determined for each arm. The Last Observation Carry Forward (LOCF) approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.|Baseline (Day 1) and Week 48|The analysis population consists of all randomized participants who had baseline LDL-C data available as well as ≥1 LDL-C measurement after initiating study treatment.|||Percent Change from Baseline||95% Confidence Interval|Mean
2580747|NCT02403674|Secondary|Percentage of Participants With Tier-2 Neuropsychiatric AEs|"The percentage of participants in each arm experiencing ≥1 pre-specified Tier-2 neuropsychiatric AEs was determined. The list of Tier-2 neuropsychiatric AE categories included depression and suicide/self-injury and psychosis and psychotic disorders."|Up to Week 48|The analysis population consists of all randomized participants who received ≥1 dose of study medication.|||Percentage of Participants|||Number
2580748|NCT02403674|Secondary|Percentage of Participants Discontinuing From Study Medication Due to an AE(s)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 48|The analysis population consisted of all randomized participants who received ≥1 dose of study medication.|||Percentage of participants|||Number
2580749|NCT02403674|Secondary|Percentage of Participants Experiencing ≥1 AE|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 48|The analysis population consisted of all randomized participants who received ≥1 dose of study medication.|||Percentage of participants|||Number
2580750|NCT02403674|Secondary|Change From Baseline in CD4 Cell Counts at Week 96|The mean change from baseline in CD4 cell counts at Week 96 will be assessed using the Observed Failure (OF) approach. With the OF approach, baseline values will be carried forward for participants who discontinued prior to Week 96 due to lack of efficacy. Cell counts at Baseline and Week 96 will be measured and expressed as cells/mm^3, and percent change will then be calculated as [(Baseline counts - Week 96 counts)*100]. CD4 cell counts will be quantified by a central laboratory using a commercially available assay.|Baseline (Day 1) and Week 96|The analysis population will consist of all randomized participants who received ≥1 dose of study medication and had baseline CD4 data available. The current results are based on the first 48 weeks of the study; Week 96 results will be provided in a future report.||||||
2580751|NCT02403674|Secondary|Change From Baseline in CD4 Cell Counts at Week 48|The mean change from baseline in CD4 cell counts at Week 48 was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued prior to Week 48 due to lack of efficacy. Cell counts at Baseline and Week 48 were measured and expressed as cells/mm^3, and percent change was then calculated as [(Baseline counts - Week 48 counts)*100]. CD4 cell counts were quantified by a central laboratory using a commercially available assay.|Baseline (Day 1) and Week 48|The analysis population consisted of all randomized participants who received ≥1 dose of study medication and had baseline and Week 48 CD4 data available.|||Percent Change from Baseline||95% Confidence Interval|Mean
2580752|NCT02403674|Secondary|Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 96|"The percentage of participants in each arm with HIV-1 RNA levels <40 copies/mL (including target detected and target not detected) at Week 96 will be determined. Plasma HIV-1 RNA levels will be quantified with the Abbott RealTime HIV-1 Assay. The US Food and Drug Administration (FDA) snapshot approach (i.e., all missing data handled as treatment failures, regardless of the reason) will be used for efficacy analyses."|Week 96|The analysis population will consist of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available. The current results are based on the first 48 weeks of the study; Week 96 results will be provided in a future report.||||||
2580753|NCT02403674|Secondary|Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48|"The percentage of participants in each arm with HIV-1 RNA levels <40 copies/mL (including target detected and target not detected) at Week 48 was determined. Plasma HIV RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach in which all missing data are considered treatment failures, regardless of the reason."|Week 48|The analysis population consists of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.|||Percentage of Participants||95% Confidence Interval|Number
2580754|NCT02403674|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96|"The percentage of participants in each arm with HIV-1 RNA levels <50 copies/mL at Week 96 will be determined. Plasma HIV-1 RNA levels will be quantified with the Abbott RealTime HIV-1 Assay. The US Food and Drug Administration (FDA) snapshot approach (i.e., all missing data handled as treatment failures, regardless of the reason) will be used for efficacy analyses."|Week 96|The analysis population will consist of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available. The current results are based on the first 48 weeks of the study; Week 96 results will be provided in a future report.||||||
2580755|NCT02403674|Primary|Percentage of Participants With Tier-1 Neuropsychiatric Adverse Events (AEs)|"The percentage of participants in each arm experiencing ≥1 pre-specified Tier-1 neuropsychiatric AEs was determined. The list of Tier-1 neuropsychiatric AE categories included dizziness, sleep disorders and disturbances, and altered sensorium (including disturbance in attention)."|Up to Week 48|The analysis population consists of all randomized participants who received ≥1 dose of study medication.|||Percentage of Participants|||Number
2580756|NCT02403674|Primary|Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL at Week 48|"The percentage of participants in each arm with HIV-1 RNA levels <50 copies/mL at Week 48 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach in which all missing data are considered treatment failures, regardless of the reason."|Week 48|The analysis population consists of all randomized participants who received ≥1 dose of study medication and had baseline HIV-1 RNA data available.|||Percentage of Participants|||Number
2580757|NCT02403635|Other Pre-specified|Apparent Total Body Clearance (CL/F) of Midazolam||prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26||||L/h||Standard Deviation|Mean
2580758|NCT02403635|Other Pre-specified|Apparent Volume of Distribution (Vd/F) of Midazolam||prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26||||L||Standard Deviation|Mean
2580759|NCT02403635|Other Pre-specified|Area Under Concentration-Time Curve up to Last Non-zero Value (AUC0-tn) of Midazolam||prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2580760|NCT02403635|Other Pre-specified|Apparent Total Body Clearance (CL/F) of ASP2151||pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12||||L/h||Standard Deviation|Mean
2580761|NCT02403635|Other Pre-specified|Apparent Volume of Distribution (Vd/F) of ASP2151||pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12||||L||Standard Deviation|Mean
2580762|NCT02403635|Other Pre-specified|Half-life (t1/2) of ASP2151||pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12||||h||Geometric Coefficient of Variation|Geometric Mean
2580763|NCT02403635|Other Pre-specified|Area Under Concentration-Time Curve Extrapolated to Infinite Time (AUC0-∞) of ASP2151||pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2580764|NCT02403635|Other Pre-specified|Area Under Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of ASP2151||pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2580765|NCT02403635|Other Pre-specified|Time of Peak Concentration (Tmax) of ASP2151||pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12||||h||Full Range|Median
2580766|NCT02403635|Other Pre-specified|Peak Plasma Concentration (Cmax) of ASP2151||pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 12||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2580767|NCT02403635|Other Pre-specified|Trough Plasma Concentration (Ctrough) of ASP2151||Days 5 to 12||||ng/mL||Standard Deviation|Mean
2580768|NCT02403635|Other Pre-specified|Half-life (t1/2) of 1-hydroxymidazolam||prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26||||h||Geometric Coefficient of Variation|Geometric Mean
2580769|NCT02403635|Other Pre-specified|Area Under Concentration-Time Curve up to Last Non-zero Value (AUC0-tn) of 1-hydroxymidazolam||prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2580770|NCT02403635|Other Pre-specified|Time of Peak Concentration (Tmax) of 1-hydroxymidazolam||prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26||||h||Full Range|Median
2580771|NCT02403635|Other Pre-specified|Peak Plasma Concentration (Cmax) of 1-hydroxymidazolam||prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2580772|NCT02403635|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Refer to the result of adverse event.|Up to 32 days after the last dose||||participants|||Number
2580773|NCT02403635|Primary|Half-life (t1/2) of Midazolam||prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26||||h||Geometric Coefficient of Variation|Geometric Mean
2580774|NCT02403635|Primary|Area Under Concentration-Time Curve Extrapolated to Infinite Time (AUC0-∞) of Midazolam||prior to initial dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16 and 24 h after dosing on Day 1, Days 12, 19 and 26||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2580777|NCT02403479|Primary|Change in Endoscopic Lund-Kennedy Score From Baseline to 6 Weeks, Then 6 Weeks to 12 Weeks|Endoscopic evaluation of the individual paranasal sinuses (left and right) and the degree of obstruction of the osteomeatal unit. Scores range from 0 to 24 with a higher number representing more severe disease.|6 weeks|chronic rhinosinusitis without polyposis patients|||score on a scale||Standard Deviation|Mean
2580778|NCT02403479|Primary|Change in Sino-nasal Outcome Test-22 Score Between Baseline and 6 Weeks, Then 6 Weeks to 12 Weeks.|The Sinonasal Outcome Test-22 is a quality of life questionnaire examining the social and emotional distress of CRS. The scores range from 0 to 110 with higher scores representing more severe disease. Total score is reported. Higher values are a worse outcome.|6 weeks||||units on a scale||Standard Deviation|Mean
2580779|NCT02403271|Secondary|Phase 2: Pharmacodynamics|BTK binding site occupancy of ibrutinib was measured from peripheral blood samples collected from participants during Cycle 3 Day 1.|Pre-dose|All subjects who received at least one dose of ibrutinib and who had at least one evaluable BTK occupancy assay result at Cycle 3 Day 1.|||percentage of BTK binding site occupancy||Standard Error|Mean
2580780|NCT02403271|Secondary|Phase 2: Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Durvalumab (MEDI4736)||From the date of first study treatment until DLT or disease progression per RECIST 1.1.|Participants who enrolled and received at least 1 dose of study treatment.|||Participants|||Count of Participants
2580781|NCT02403271|Secondary|Phase 1b: Pharmacodynamics|BTK occupancy|From the date of first study treatment until DLT or disease progression per RECIST 1.1.|Data not collected||||||
2580782|NCT02403271|Secondary|Phase 1b/2: Pharmacokinetics (Ctrough) of Durvalumab (MEDI4736)|Ctrough = the trough plasma concentration of durvalumab (MEDI4736) after administration on Cycle 6 Day 1|Pre-dose|All participants who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2580783|NCT02403271|Secondary|Phase 1b/2: Pharmacokinetics (Cmax) of Durvalumab (MEDI4736)|Cmax = the peak (maximum) plasma concentration of durvalumab (MEDI4736) after administration on Cycle 6 Day 1.|60 minutes post-dose (dose administered as an infusion over a 1 hour period)|All participants who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2580784|NCT02403271|Secondary|Phase 1b/2: Pharmacokinetics (AUC0-24h) of Ibrutinib|AUC0-24 = the area under the plasma concentration-time curve of ibrutinib during the dosing interval on Cycle 3 Day 1|0hr, 1hr, 2hr, and 4hr post-dose|All participants who received at least one dose of study treatment and had evaluable pharmacokinetic data. Data were analyzed together for Phase 1b/2 because the dose was the same.|||h.ng/mL||Standard Deviation|Mean
2580785|NCT02403271|Secondary|Phase 1b/2: Pharmacokinetics (Cmax) of Ibrutinib|Cmax = the peak (maximum) plasma concentration of ibrutinib during the dosing interval on Cycle 3 Day 1.|0hr, 1hr, 2hr, and 4hr post-dose|All participants who received at least one dose of study treatment and had evaluable pharmacokinetic data. Data were analyzed together for Phase 1b and Phase 2 because the dose was the same.|||ng/mL||Standard Deviation|Mean
2580786|NCT02403271|Primary|Phase 2: Efficacy of Ibrutinib in Combination With Durvalumab (MEDI4736) in Participants With Relapsed or Refractory Solid Tumors by Assessing the ORR Per RECIST 1.1.||From the date of first study treatment until progressive disease per RECIST 1.1 or unacceptable toxicity.|The Response-evaluable population was participants who received at least 1 dose of treatment (ibrutinib and durvalumab) and provided 1 post-baseline response assessment.|||Participants|||Count of Participants
2580787|NCT02403271|Primary|Phase 1b: Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib and Durvalumab (MEDI4736) and to Find the Recommended Phase II Dose.||From the date of first study treatment until DLT or disease progression per RECIST 1.1.||||participants|||Number
2580788|NCT02403206|Secondary|Operating Time in the Eye to Complete Entire Cataract Procedure|Operating time in the eye was the time interval (in seconds) from the time the corneal incision was opened to the time the wound was closed. Only one eye (study eye) contributed to the analysis.|Day 0 (operative day)|Intent-to-Treat Analysis Set|||seconds||Standard Deviation|Mean
2580789|NCT02403206|Primary|Percentage of Capsular Tears (Anterior or Posterior) During Surgery|A capsular tear is defined as any unintended tear on the anterior or posterior capsule and includes a radial tear that moves peripherally on the anterior capsule during capsulotomy and extends to form a posterior capsular tear during intumescent cataract surgery. An intumescent cataract is defined as a cataract with a pressurized capsular bag. A lower value indicates fewer capsular tears. Only one eye (study eye) contributed to the analysis.|Day 0 (operative day)|Intent-to-Treat Analysis Set|||percentage of capsular tears|||Number
2580790|NCT02403180|Secondary|Mean Area of Focus Under the Mean Defocus Curve After 5 +/- 1 Days of Contact Lens Wear|Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Trial Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus.|Day 5, each product|Intention to treat participants with non-missing observations|||diopter*logMar||Standard Deviation|Mean
2580791|NCT02403180|Primary|Mean Stereoacuity at Near After 5+/-1 Days of Contact Lens Wear|Stereoacuity (SA) is the ability to detect differences in distance (depth perception). Near SA was measured at a distance of 40 cm using the Howard-Dolman system. A lower SA value indicates better depth perception.|Day 5, each product|Intention to treat participants with non-missing observations|||arcsec||Standard Deviation|Mean
2580792|NCT02403154|Secondary|Compare the Functional Outcome Scores (PROMIS Pain Interference, PROMIS Mobility, PROMIS Global Satisfaction With Sex Life, PROMIS Depression, Majeed Score, SF-12, VAS, Patient Satisfaction Score, and (Only in Men) PROMIS Erectile Function)|We will ask patients multiple questionnaires to asses their functional outcomes after surgery. These questionnaires include: PROMIS Pain Interference, PROMIS Mobility, PROMIS Global Satisfaction with Sex Life, PROMIS Depression, Majeed score, SF-12, VAS, patient satisfaction score, and (only in men) PROMIS Erectile Function.|24 hours - 24 months|||||||
2580794|NCT02403154|Secondary|Health-related Qualify of Life|We will ask patients multiple questionnaires to assess their quality of life after surgery. These questionnaires include: PROMIS Pain Interference, PROMIS Mobility, PROMIS Global Satisfaction with Sex Life, PROMIS Depression, Majeed score, SF-12, VAS, patient satisfaction score, and (only in men) PROMIS Erectile Function.|24 hours - 24 months|||||||
2580795|NCT02403154|Secondary|Revision Surgery Rates|We will compare the revision surgery rates between the two interventions.|24 hours - 24 months|||||||
2580796|NCT02403154|Secondary|Infection Rates|We will compare the rate of infection between the two interventions.|24 hours - 24 months|||||||
2580797|NCT02403154|Secondary|Implant Breakage or Failure Rates|We will compare the implant failure/breakage rate between the two interventions.|24 hours - 24 months|No analyses were done on this study. We did not enroll enough patients in order to come to any conclusions prior to the PI leaving the institution.||||||
2580798|NCT02403154|Primary|Functional Outcomes (PROMIS v1.2-Physical Function Instrument)|The primary objective is to compare functional outcomes between subcutaneous internal fixation and external fixation as measured by the PROMIS v1.2-Physical Function instrument.|24 hrs - 24 months|No data was analyzed for this study. The PI left our institution and the study was pre-maturely closed. With such a small patient population, the data that was collected was not analyzed because achieving statistical significance was not possible.||||||
2580799|NCT02402933|Other Pre-specified|Change in Blood Glucose Level Over Time|Glucometer-based measurements of blood glucose after the studied drug administration. The participants' change in blood glucose level from baseline (just prior to dosing or right after the study drug administration) was measured by the caregiver using a glucometer at 15, 30 and 45 minutes after NG administration. The change in glucose was calculated from each time point (15, 30 and 45 minutes) minus the baseline.|Baseline (just prior to dosing or right after study drug administration), 15, 30 and 45 minutes after drug administration for an episode of hypoglycemia|Participants received at least 1 dose of the NG and experienced at least 1 hypoglycemic event. Participants from the GCP non-compliant site were considered ineligible and thus excluded from this population.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
2580800|NCT02402933|Secondary|Percentage of Participants With Adverse Events Through the Nasal Score Questionnaire|"Adverse events solicited through the Nasal Score Questionnaire included: runny nose, nasal congestion (nostrils plugged), nasal itching, sneezing, watery eyes, itchy eyes, redness of eyes, itching of ears, itching of throat, and other.~A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section."|Within 2 hours of full recovery from a hypoglycemic event|Participants who received at least 1 dose of NG and experienced at least 1 hypoglycemic event.Participants from the GCP non-compliant site were considered ineligible and thus excluded from this population.|||percentage of participants|||Number
2580801|NCT02402933|Secondary|Assessment of Ease-of-use of Dry-Mist Nasal Glucagon by Completion of Questionnaire by the Caregiver|"Assess ease-of-use of intranasal administered glucagon in the hands of caregivers of participants who may be called upon to treat episodes of hypoglycemia.~Measurement for Degree of difficulty: opening the kit, Degree of difficulty: understanding the instructions on how to use the kit, Degree of difficulty: administering the medication into the nostril, Degree of satisfaction is 1 (Very Difficult) to 7 (Very Easy). Measurement for Dry Mist Nasal Glucagon will be easy to teach other caregivers, Nasal formulation of glucagon is less intimidating for caregivers, Dry Mist Nasal Glucagon is easy to carry and would be willing to carry it, Intranasal delivery of glucagon is preferable: level of agreement 1 (Strongly Disagree) to 7 (Strongly Agree)."|After each drug administration for an episode of hypoglycemia|"Participants who received at least 1 dose of NG and experienced at least 1 hypoglycemic event. Participants from the GCP non-compliant site were excluded. Proportions and n are based on the total number of hypoglycemic events (N=33) of 14 participants; except Compare to Injectable is based on 8 events."|||Hypoglycemic Events|Hypoglycemic Events||Count of Units
2580802|NCT02402933|Primary|Number of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration|Responses to questions completed by the caregiver are used to assess this outcome. An episode of severe hypoglycemia is generally defined as an event associated with severe neuroglycopenia usually resulting in coma or seizure and requiring parenteral therapy (glucagon or intravenous glucose) administered by a third party. In this study moderate hypoglycemia is defined as an episode wherein the child/adolescent with diabetes has symptoms and/or signs of neuroglycopenia and has a blood glucose ≤3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]) based on a blood sample taken at or close to the time of treatment.|Within 30 minutes after each drug administration for an episode of hypoglycemia|Participants who received at least 1 dose of NG with evaluable treatment response. Events for which participants required external professional medical assistance or used injected glucagon or oral carbohydrates within 30 minutes and before responding were non-evaluable. The good clinical practice (GCP) non-compliant site were also excluded.|||participants|||Number
2580803|NCT02402881|Secondary|Number of Participants With Venous Thromboembolism|This is the number of participants with VTE events as documented in the electronic health record.|15 Months|Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. Overall number of participants represents the number of unique patients in the study. These numbers reflect patient visits at baseline and following the implementation of the patient education intervention.|||Participants|||Count of Participants
2580804|NCT02402881|Primary|Percentage of Non Administration of Prescribed VTE Prophylaxis Medication Doses|This is the percentage of venous thromboembolism (VTE) prophylaxis doses that were not administered for any reason as documented in the electronic health record by a nurse.|15 Months|Each row represents a different period of the study (pre intervention and post intervention) with different number of participants. Overall number of participants represents the number of unique patients in the study. These numbers reflect patient visits at baseline and following the implementation of the patient education intervention.|||Percentage of nonadministration||95% Confidence Interval|Number
2580805|NCT02402764|Secondary|Overall Survival (OS)|Overall survival, defined as the time from randomization to death from any cause.|End of post-treatment 12 month follow-up, up to 24 months per participant|All participants|||months||95% Confidence Interval|Median
2581819|NCT02388568|Secondary|Proportion Maintaining >= 10% Loss of Initial Weight|This is the number of participants who maintained >=10% loss of initial weight in the randomization to week 52 trial period.|52 weeks post-randomization||||Participants|||Count of Participants
2580806|NCT02402764|Secondary|Progression-Free Survival (PFS)|Median time to progression. Progression-free survival is defined as time elapsed from the beginning of study treatment to the first documentation of radiologic progression as defined by standard RECIST criteria or death.|Up to 10 months|All participants|||months||95% Confidence Interval|Median
2580807|NCT02402764|Secondary|Duration of Overall Response|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started) or death. The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented or death.|Up to 10 months|Participants with Complete Response or Partial Response||||||
2580808|NCT02402764|Secondary|Best Overall Response (OR)|The best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.|Up to 10 months|Participants with Complete Response or Partial Response||||||
2580809|NCT02402764|Primary|Clinical Benefit Rate|Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) ≥ 12 weeks of selinexor in patients with triple negative breast cancer (TNBC), according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions; PR: At least a 30% decrease in the sum of the diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 10 months|All participants|||Participants|||Count of Participants
2580810|NCT02402452|Secondary|Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAE) and Laboratory Abnormalities|The percentage of participants experiencing any TEAE or treatment-emergent laboratory abnormality was summarized.|First dose date to Day 31|Participants in the Safety Analysis Set were analyzed.|||percentage of participants|||Number
2580811|NCT02402452|Primary|PK Parameter of Voxilaprevir: Cmax|Cmax is defined as the maximum observed plasma concentration of drug. Data presented are unadjusted geometric means and confidence intervals.|0 (pre-dose ≤ 5 minutes), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose|Participants in the PK Analysis Set were analyzed.|||ng/mL||95% Confidence Interval|Geometric Mean
2580812|NCT02402452|Primary|PK Parameter of Voxilaprevir: AUCinf|AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time. Data presented are unadjusted geometric means and confidence intervals.|0 (pre-dose ≤ 5 minutes), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose|Participants in the PK Analysis Set were analyzed.|||h*ng/mL||95% Confidence Interval|Geometric Mean
2580813|NCT02402452|Primary|Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast|AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration. Data presented are unadjusted geometric means and confidence intervals.|0 (predose ≤ 5 min) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose|PK Analysis Set included all enrolled participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose concentration value reported by the PK laboratory for the corresponding analyte.|||h*ng/mL||95% Confidence Interval|Geometric Mean
2580814|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Social Support Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.||||units on a scale (range= 0-100)||Standard Deviation|Mean
2580815|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Stress Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.||||units on a scale (range= 0-10)||Standard Deviation|Mean
2580816|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Family Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.||||units on a scale (range= 0-10)||Standard Deviation|Mean
2580817|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Social Life Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.||||units on a scale (range= 0-10)||Standard Deviation|Mean
2580861|NCT02401529|Primary|Maximum Severity of Post-operative Pain|5 grades (pain free, low disability and low intensity, low disability and high intensity, high disability and moderate intensity, high disability and severly limiting)|The severest pain grade felt within a week||||participants|||Number
2580818|NCT02402322|Secondary|Change From Baseline Score in the Sheehan Disability Inventory (Work Subscale) at 8 Weeks and 6 Months.|This 5-item instrument assesses functional impairment at work, and in social and family life. There are 5 subscales: work, social life, family life, stress, social support. The first three subscales range from 0 to 10, with higher scores indicating greater disability. The fourth subscale (stress) range from 0 to 10, with higher scores indicating greater stress perceived. The fifth subscale (Social Support Subscale) ranges from 0 to 100, with higher scores indicating greater social support perceived.There is not a total score.|Baseline, 8 weeks, 6 months.||||units on a scale (range= 0-10)||Standard Deviation|Mean
2580819|NCT02402322|Secondary|Change From Baseline Score in the Beck Depression Inventory at 8 Weeks and 6 Months.|Beck Depression Inventory-II (BDI-II), Spanish adaptation (38, 39). This 21-item self-reported instrument evaluates symptoms of depression. Score range:0- 63, with 3 levels of severity, 10-18 mild depression, 19-29 moderate depression and >30 severe depression.|Baseline, 8 weeks, 6 months.||||units on a scale (range= 0-63)||Standard Deviation|Mean
2580820|NCT02402322|Secondary|Change From Baseline Score in the Beck Anxiety Inventory at 8 Weeks and 6 Months.|Beck Anxiety Inventory (BAI), Spanish adaptation . This 21-item self-reported instrument evaluates the cognitive and physical symptoms of anxiety. Score range:0- 63, with 3 levels of severity 0-21 mild anxiety, 22-35 moderate anxiety and 36-63 severe anxiety.|Baseline, 8 weeks, 6 months.||||units on a scale (range= 0-63)||Standard Deviation|Mean
2580821|NCT02402322|Primary|Change From Baseline Score in the Anxiety Sensitivity Index-3 at 8 Weeks and 6 Months.|This 18-item scale evaluates sensitivity to anxiety symptoms on 3 dimensions: physical, cognitive, and social.There are 3 subscales, physical, cognitive, and social. For both the subscales (which range from 0 to 24) and the total scale (which range from 0 to 72), higher scores correspond to greater anxiety sensitivity.|Baseline, 8 weeks, 6 months.||||units on a scale (range= 0-72)||Standard Deviation|Mean
2580822|NCT02402322|Primary|Change From Baseline Score in the Panic Disorder Severity Scale at 8 Weeks and 6 Months.|Panic Disorder Severity Scale Self-Report (PDSS-SR). This 7-item scale assesses the severity of PD through questions about the frequency of panic attacks, associated distress, anticipatory anxiety, agoraphobic and interoceptive avoidance, and social and work impairment. Score range: 0-28. Scores up to 10 correspond with ''mild,'' those between 11 and 15 with ''moderate,'' and those at or above 16 with ''severe'' panic disorder.|Baseline, 8 weeks, 6 months.||||units on a scale (range= 0-28)||Standard Deviation|Mean
2580823|NCT02402296|Secondary|Matrix Metallo-proteinase (MMP-1&9)|Their immuno-expression was assessed in the gingival samples harvested from the gingiva adjacent to hopeless teeth (planned to be extracted for dento-periodontal causes)|Day 0 and day 91 post therapy|A total of 30 localized aggressive periodontitis(LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings.|||percentage of change||Standard Deviation|Mean
2580824|NCT02402296|Secondary|Gingival Index (GI)|"Using the values of the gingival index according to (Loe & Silness, 1963); 0-no bleeding on probing~delayed bleeding on probing~immediate bleeding on probing~spontaneous bleeding"|Day 0 and day 91 post therapy|A total of 30 localized aggressive periodontitis(LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings.|||percentage of change||Standard Deviation|Mean
2580825|NCT02402296|Secondary|Pocket Depth (PD)|It is the distance from the base of the pocket till the gingival margin using Williams graduated probe|Day 0 and day 91 post therapy|A total of 30 localized aggressive periodontitis(LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings|||percentage of change||Standard Deviation|Mean
2580826|NCT02402296|Primary|Assessment of Change in Clinical Attachment Level (CAL)|It is the distance from the base of the pocket till the cemento-enamel junction using Williams graduated probe|Day 0 and day 91 post therapy|A total of 30 localized aggressive periodontitis (LAP) participants were included in this study. Medical and dental histories were obtained and intraoral examinations were carried out at pre-screening visit. Patients were diagnosed to have LAP based on the clinical and radiographic findings measurements|||percentage of change||Standard Deviation|Mean
2580827|NCT02402218|Secondary|Number of Participants With Re-Infection After Achieving Sustained Virologic Response by Intervention Group|Number of persons who achieved sustained virologic response following treatment who subsequently have HCV RNA detected with a new strain of the virus.|at post-treatment week 12|Among participants that initiated treatment only.|||Participants|||Count of Participants
2580828|NCT02402218|Secondary|Change in Illicit Drug Use During HCV Treatment|Illicit drug use during HCV treatment measured by urine toxicology testing pre-treatment and at treatment week 6|Pre-treatment and at treatment week 6|Participants that completed urine toxicology tests at enrollment and week 6 of treatment|||Participants|||Count of Participants
2580829|NCT02402218|Secondary|Change in Alcohol Use by Blood Test During HCV Treatment|Alcohol intake during HCV treatment measured using dried whole blood spots to measure the level of phosphatidylethanol (PEth) at pre-treatment and treatment week 6|Pre-treatment and at treatment week 6|Participants that completed PEth tests at enrollment and week 6 of treatment|||Participants|||Count of Participants
2580830|NCT02402218|Secondary|Number of Participants With Adverse Events During HCV Treatment by Intervention Group|Number of Participants who self-reported Adverse Events During HCV Treatment by Intervention Group|at post-treatment week 12|Among participants that initiated treatment only.|||Participants|||Count of Participants
2580831|NCT02402218|Secondary|Sustained Virologic Response (SVR) Following Treatment by Intervention Group|The number of participants who achieved SVR, defined as HCV RNA not detected at 12 weeks after completion of the HCV treatment regimen|at post-treatment week 12||||Participants|||Count of Participants
2580832|NCT02402218|Primary|Participants Who Initiated HCV Therapy by Intervention Group|The percentage of participants who initiated HCV therapy [Ledipasvir/Sofosbuvir (LDV/SOF)] with Usual Care (UC), Incentive Care (IC), and Peer-Mentor Care (PMC).|at week 1||||Participants|||Count of Participants
2581820|NCT02388568|Secondary|Body Weight (% Change)|The % change in body weight from randomization to week 52.|52 weeks post-randomization||||% change||Standard Error|Mean
2580833|NCT02402166|Secondary|Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC 0-last) of SPD489 in Plasma|AUC 0-last is the area under the concentration-time curve from time zero to the time of the last quantifiable concentration of SPD489 in plasma. Pharmacokinetic (PK) parameters were compared against the study NRP104-201 (NCT00557011) to observe and compare the effects of SPD489.|Visit 7 [Dose Maintenance Phase] at pre-dose, and 1, 2, 3, 4, 6, and 8 h post-dose|The PK set consisted all participants in the safety analysis set for whom the primary PK data were considered sufficient and interpretable. PK assessments were performed only during the Dose Maintenance Period (2 weeks) for SPD 489 10, 15 and 30 mg reporting groups.|||hour*nanogram/millilitre(h*ng/mL)||Standard Deviation|Mean
2580834|NCT02402166|Secondary|Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)|"CGI-I was performed to rate the severity of a participant's condition on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse). Data presented here was analysed at Final on-Treatment Assessment (FoTA). Improved is defined as a score of very much improved or much improved."|FoTA|Full analysis set consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD-RS-IV Preschool Version total score assessment.|||Participants|||Count of Participants
2580835|NCT02402166|Secondary|Change From Baseline in Attention Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Preschool Version Total Score at FoTA (Final on Treatment Assessment)|The ADHD-RS-IV Preschool Version is an 18-item questionnaire that requires the respondent to rate the frequency of occurrence of ADHD symptoms as defined by Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition (DSM-IV-TR) criteria. Each item is scored on a 4-point scale ranging from 0 (never or rarely) to 3 (very often) with total scores ranging from 0-54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17). Data presented here was analysed at Final on-Treatment Assessment (FoTA).|Baseline, FoTA|Full analysis set consisted of all participants in the safety analysis set who had at least 1 post-dose ADHD-RS-IV Preschool Version total score assessment.|||Units on a Scale||Standard Deviation|Mean
2580836|NCT02402166|Primary|Number of Participants With Suicide Related Behavior Assessed by Columbia-Suicide Severity Rating Scale Questionnaire (C-SSRS)|"The C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answer to the first 2 ideation questions was yes, the clinician asked questions 3-5. Active suicidal ideation included any participant who answered yes to questions 2-5. If the answers to ideation questions 1 and 2 were No, then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide."|Baseline, Week 8/ET|Safety analysis set consisted of all participants who had taken at least 1 dose of investigational product.|||Participants|||Count of Participants
2580837|NCT02402166|Primary|Change in Sleep Patterns Assessed by Children's Sleep Habits Questionnaire at Week 8 / End of Treatment (ET)|Children's Sleep Habits Questionnaire is a tool designed to screen the most common sleep problems in children, and consists of 33 items for scoring. The instrument evaluates the child's sleep based on behavior within 8 different subscales: bedtime resistance, sleep-onset delay, sleep duration, sleep anxiety, night walkings, parasomnias, sleep-disordered breathing, and daytime sleepiness. Each item receives a score from 1 (problem occurs rarely) to 3 (problem usually occurs); therefore, a higher score is the worse outcome. Scale ranges are as follows: bedtime resistance: 6 to 18, sleep onset delay: 1 to 3, sleep duration: 3 to 9, sleep anxiety: 4 to 12, night walkings: 3 to 9, parasomnias: 7 to 21, sleep-disordered breathing: 3 to 9, daytime sleepiness: 8 to 24, and total disturbance (items from all scales): 33 to 99.|Baseline, Week 8/ET|Safety analysis set consisted of all participants who had taken at least 1 dose of investigational product. Here number of participant analysed for the each sub-scale is specified for this endpoint.|||Units on a Scale||Standard Deviation|Mean
2580838|NCT02402166|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) at the Specified Dose Level|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was considered treatment-emergent if it had a start date on or after, or had a start date before but increased in severity after the first dose of investigational product.|From start of study treatment up to safety follow-up (Week 9)|Safety analysis set consisted of all participants who had taken at least 1 dose of investigational product. Reporting groups are defined by the dose taken prior to the onset of the TEAE (Treatment Emergent Adverse Event). Number of participants analysed (N) are specific to the reporting group at the specific dose level.|||Participants|||Count of Participants
2580839|NCT02402153|Secondary|Usability: Reported Discomfort Related to the Implant at the End of the Study|"The discomfort was recorded by the study subjects 51±3 days after implantation. Reported discomfort was evaluated by the following question: How much do you agree with the following statement: I have not experienced any implant discomfort the past two days?. The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1)."|51±3 days after implantation||||units on a scale||Standard Deviation|Mean
2580840|NCT02402153|Secondary|Usability: Reported Discomfort Related to the Implant in the Beginning of the Study|"The discomfort was recorded by the study subjects 19±4 days after implantation. Reported discomfort was evaluated by the following question: How much do you agree with the following statement: I have not experienced any implant discomfort the past two days?. The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1)."|19±4 days after implantation||||units on a scale||Standard Deviation|Mean
2580841|NCT02402153|Secondary|Usability: Reported Discomfort During Night While Wearing the Device|"The discomfort during the night was recorded by the study subject every night wearing the device. Reported discomfort was evaluated by the following question: How much do you agree with the following statement: There has been no discomfort while wearing the HypoSafe device during night?. The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1)."|1 month||||units on a scale||Full Range|Mean
2580842|NCT02402153|Secondary|Usability: Reported Discomfort During Day While Wearing the Device|"The discomfort during the day was recorded by the study subject every day wearing the device. Reported discomfort was evaluated by the following question: How much do you agree with the following statement: There has been no discomfort while wearing the HypoSafe device during day?. The scale ranged from 1 to 5 (strongly agree = 5, agree = 4, neutral = 3, disagree = 2, strongly disagree=1)."|1 month||||units on a scale||Full Range|Mean
2580843|NCT02402153|Primary|Performance: Continuous EEG|Average time of EEG recordings (hours/day)|1 month|"Exclusion of data points (n=8) in the analysis:~A software bug resulted in reduced data storage (n=4). After an amendment to the study protocol, EEG data was collected for the first 3 weeks. The subsequent 2 weeks subjects were monitored, but EEG data not collected (n=4)."|||hours/day||Standard Deviation|Mean
2580844|NCT02402153|Primary|Performance: EEG Quality|"The power spectrum densities from the two modalities were directly compared on an integer scale from -5 to 5, where -5 signifies that the scalp EEG was of much higher quality than the subcutaneous. 0 means they were of equal quality and 5 means the subcutaneous signal was of much higher quality"|1 month|Exclusion of data points (n=5) in the analysis: A software bug and usage error of the control setup.|||Score||Standard Deviation|Mean
2580845|NCT02402153|Primary|Performance: EEG Recordings - Impedance|The EEG performance was measured as the mean impedance as a function of time. An impedance value below 5 kOhm is considered very good.|1 month|"Exclusion of data points (n=6) in the analysis:~A software bug resulted in no data storage (n=2). After a protocol amendment, EEG data was collected for the first 3 weeks only. The subsequent 2 weeks subjects were monitored, but EEG data not collected (n=4)."|||Impedance (kOhm)||Standard Deviation|Mean
2580846|NCT02402127|Secondary|Average Coefficient of Friction of Unworn Lenses|Unworn contact lenses were removed from the commercial packaging and the coefficient of friction of the unworn lenses was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity.|Day 1 (each product)|Intention to treat participants with non-missing observations|||unitless|Participants|Standard Deviation|Mean
2580847|NCT02402127|Primary|Average Coefficient of Friction of Worn Lenses at 16 Hours|Worn contact lenses were removed from the participant's eye and the coefficient of friction was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.|Day 1, Hour 16, each product|Intention to treat participants with non-missing observations|||unitless||Standard Deviation|Mean
2580848|NCT02402036|Primary|Serum microRNA Quantification|Serum microRNAs will be quantified using miScript MiRNA PCR arrays|2 years|Due to issues with recruitment and the principal investigator leaving the institution, no analysis of the collected samples was performed.||||||
2580849|NCT02401867|Primary|Concordance Between Vaginal Self-swab Results and Provider-collected Cervical Swab Results for HPV DNA Among Sexually Active FTM Adults|Quantitatively assessed the non-inferiority of vaginal self-swab for HPV DNA compared to provider-collected cervical swab for HPV via laboratory confirmed testing in sexually active FTM adults. Compared the concordance of the positive self-swab HPV DNA test results to the positive cervical provider swab HPV DNA test results (reference) using the McNemar's test, a two-sample test for binomial proportions for matched-pair data.|1 day|Analytic sample =131: 10 participants did not receive both the vaginal self-swab HPV DNA test and the provider cervical test (reference); 7 received the self, but not the provider; 1 received the provider, but not the self; 2 did not receive either test. Additionally, 9 of the provider samples could not be assayed due to low cellular content.|||Participants|||Count of Participants
2580850|NCT02401555|Primary|Diagnostic Result of Assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay) From Accuracy Analysis|The purpose of this study was to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay, a single-use immunochromatographic assay for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types1 and 2 (HIV-1 and HIV-2) in fingerstick whole blood, venous whole blood, serum, or plasma (EDTA, heparin and sodium citrate). The Accuracy analysis on the serum samples is a proportion of results that are correctly identified as such.|Up to 9 months||||Percentage of True Results||95% Confidence Interval|Number
2580851|NCT02401542|Primary|Primary Efficacy Outcome: Progression Free Survival (PFS)|Efficacy of vofatamab plus docetaxel, compared with docetaxel plus placebo, and vofatamab alone as measured by PFS; measured from randomization to first occurrence of disease progression (per RECIST v1.1) or death, whichever occurs first. A patient has had to receive at least one vofatamab dose. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|3-4 years||||Months||Standard Deviation|Mean
2580852|NCT02401529|Secondary|Average Frequency of Meals Per Day|average frequency of meals (1 meal, 2 meals, if more specify)|average number of meals consumed per day for the 1st three days post-surgery||||participants|||Number
2580853|NCT02401529|Secondary|Average Amount of Meal Per Day|adequacy of meals (inadequate, adequate)|3 days||||participants|||Number
2580854|NCT02401529|Secondary|Onset of 1st Post-operative Oral Intake|feeding onset (1st day i. surgery day, 2nd day, 3rd day)|Onset of 1st post-operative oral intake recorded within the 1st 3days post-surgery||||participants|||Number
2580855|NCT02401529|Primary|Total Number of Post-operative Vomiting Episodes|Postoperative vomiting number of attacks (no vomiting,1, 2, 3, if more specify)|total number of post-operative vomiting episodes which were experienced within the 1st week post-surgery||||participants|||Number
2580856|NCT02401529|Primary|Occurence of Postoperative Vomiting|Postoperative vomiting occurrence (yes, no)|7 days||||participants|||Number
2580857|NCT02401529|Primary|Duration of Post-operative Nausea|Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify)|7 days||||participants|||Number
2580858|NCT02401529|Primary|Onset of Post-operative Nausea|Postoperative nausea onset (no nausea, immediate, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, 7th day)|onset of 1st ocurence of nausea attack within the 1st week post-surgery||||participants|||Number
2580859|NCT02401529|Primary|Occurence of Post-operative Nausea|Postoperative nausea occurence (yes, no)|7 days||||participants|||Number
2580860|NCT02401529|Primary|Duration of Post-operative Pain|4 selections (1 day, 2 days, 3 days, if more specify)|number of days at which pain was experienced within the the 1st sevn days post -surgery||||participants|||Number
2580862|NCT02401464|Secondary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.|||participants|||Number
2580863|NCT02401464|Secondary|Number of Participants Who Had Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.|||participants|||Number
2580864|NCT02401464|Secondary|Number of Participants With TEAEs Related to Body Weight||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.|||participants|||Number
2580865|NCT02401464|Secondary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.|||participants|||Number
2580866|NCT02401464|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)||Baseline up to Day 6 of Intervention Period 2|The safety analysis set included all participants who received the study drug at least once.|||participants|||Number
2580867|NCT02401464|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-536 in Granule Cohort||Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.|||ng/mL||Standard Deviation|Mean
2580868|NCT02401464|Primary|AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Granule Cohort||Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
2580869|NCT02401464|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-536 in Dry Syrup Cohort||Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2580870|NCT02401464|Primary|AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose for TAK-536 in Dry Syrup Cohort||Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and were evaluable for pharmacokinetics.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
2580871|NCT02401412|Secondary|Peristomal Skin Complication Rate|Observed 8 week Peristomal Skin Complication (PSC) rate. The validated Ostomy Skin Tool DET score was used to describe the status of the peristomal skin. Subjects were deemed to have had a PSC if the DET score was above zero due to anything other than normal postoperative healing and/or scar tissue, or the DET score increased above the normal score obtained at a previous visit.|8 weeks|"The analysis population was defined as a modified ITT population which excluded subjects who~were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16)~did not receive the study device; (n=1)~As such 153 (170-17) subjects were eligible for analysis"|||Participants|||Count of Participants
2580872|NCT02401412|Primary|Stoma Related Cost of Care|12 week stoma related cost of care. Cost of care includes treatments related to ostomy and/or PSCs (topical medications, clinic visits, and selected accessory use), social impact of ostomy and/or PSCs (missed work/ appointments), ostomy-related hospitalizations, emergency department visits, physician/clinic visits, medication use and therapies, and product utilization.|12 weeks|"The analysis population was defined as a modified ITT population which excluded subjects who~were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16)~did not receive the study device; (n=1)~As such 153 (170-17) subjects were eligible for analysis"|||USD||95% Confidence Interval|Least Squares Mean
2580873|NCT02401256|Primary|Efavirenz AUC0-inf (Single Dose) and AUC0-24(Multiple Dose)|After the samples collection, blood from phase 2 and phase 4 were used to perform the quantification of Efavirenz in plasma. The composite of the efavirenz concentration (blood collection between 0 to 120 hrs) were used to calculate the area under the plasma concentration time curve (AUC0-inf for single dose and AUC0-24 for multiple dose) of efavirenz.|Single dose pharmacokinetics (PK) versus multiple doses (after 17 day pretreatment) PK (total 38 days for each subject)|Just volunteers with Efavirenz quantification information (complete or partial) and CYP2B6 genotype were included in this data analysis (Total of 61)|||h*uM||Standard Deviation|Mean
2580874|NCT02401230|Secondary|Median Peripheral Blood Mononuclear Cell (PBMC) Deoxyadenosine Triphosphate (dATP) Concentration|Median blood dATP concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Baseline, Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||fmol/million cells||Inter-Quartile Range|Median
2580875|NCT02401230|Secondary|Median Rectal Tissue Deoxycytidine Triphosphate (dCTP) Concentration|Median rectal tissue dCTP concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Baseline, Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||fmol/mg tissue||Inter-Quartile Range|Median
2580876|NCT02401230|Secondary|Median Rectal Tissue Deoxyadenosine Triphosphate (dATP) Concentration|Median rectal tissue dATP concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Baseline, Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||fmol/mg tissue||Inter-Quartile Range|Median
2580877|NCT02401230|Secondary|Median Rectal Tissue Tenofovir (TDF) Concentration|Median rectal tissue TDF concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||fmol/mg tissue||Inter-Quartile Range|Median
2581878|NCT02387957|Primary|Total Number of Other Adverse Events (>5%)|Number of Patients with Other Adverse Events|2 years||||Participants|||Count of Participants
2580878|NCT02401230|Secondary|Median Rectal Tissue Emtricitabine (FTC) Concentration|Median rectal tissue FTC concentrations as measured in fmol/mg tissue prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||fmol/mg tissue||Inter-Quartile Range|Median
2580879|NCT02401230|Secondary|Median Peripheral Blood Mononuclear Cell (PBMC) Tenofovir (TDF) Concentration|Median blood PBMC TDF concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||fmol/million cells||Inter-Quartile Range|Median
2580880|NCT02401230|Secondary|Median Peripheral Blood Mononuclear Cell (PBMC) Emtricitabine (FTC) Concentration|Median blood PBMC FTC concentrations as measured in fmol/million cells prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||fmol/million cells||Inter-Quartile Range|Median
2580881|NCT02401230|Secondary|Median Rectal Secretion Tenofovir (TDF) Concentration|Median rectal secretions TDF concentrations as measured in ng/swab prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||ng/swab||Inter-Quartile Range|Median
2580882|NCT02401230|Secondary|Median Rectal Secretion Emtricitabine (FTC) Concentration|Median rectal secretions FTC concentrations as measured in ng/swab prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||ng/swab||Inter-Quartile Range|Median
2580883|NCT02401230|Secondary|Median Plasma Tenofovir (TDF) Concentration|Median plasma TDF concentration as measured in ng/ml prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||ng/ml||Inter-Quartile Range|Median
2580884|NCT02401230|Secondary|Median Plasma Emtricitabine (FTC) Concentration|Median plasma FTC concentration as measured in ng/ml prior to product use and on day 8 after product use. The higher the concentration, the better the drug distribution.|Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||ng/ml||Inter-Quartile Range|Median
2580885|NCT02401230|Primary|Median Cumulative Amount of p24|The median cumulative amount of p24 produced in a rectal explant challenge assay as measured by ELISA from participants prior to product use and on day 8 after product use.|Baseline, Post-Intervention (Day 8)|Number of participants who provided a viable sample.|||pg/mL||Inter-Quartile Range|Median
2580886|NCT02401230|Primary|Median Percentage of CD4 Positive T-Cells|HIV target cell availability will be assessed by the median percentage of CD4+ T cells that express HIV co-receptor CCR5 as measured prior to product use and on day 8 after product use.|Baseline, Post-Intervention (Day 8)|The analysis population includes participants for whom the assay could be accurately performed. Data were not available for analysis in the case of an insufficient sample to perform this assay, poor performance of the assay, or technical issues in the laboratory.|||percentage positive T-cells||Inter-Quartile Range|Median
2580887|NCT02401048|Secondary|Pharmacodynamics of MEDI4736 in Subjects With Relapsed or Refractory Lymphomas|Detectable Free Serum PD-L1 level|Cycle 3 Day1 Pre-dose|In Follicular lymphoma expansion cohort, 7 subjects are below limit of quantitation. In Diffuse large B-cell lymphoma expansion cohort, all subjects below limit of quantitation.|||pg/mL|||Number
2580888|NCT02401048|Secondary|Pharmacodynamics of Ibrutinib in Subjects With Relapsed or Refractory Lymphomas|BTK occupancy|Cycle 3 Day 1 Pre-dose|All participants who received at least one dose of study treatment and had evaluable pharmacodynamics data.|||BTK % occupancy||Standard Error|Mean
2580889|NCT02401048|Secondary|Bruton Tyrosine Kinase (BTK) Occupancy|BTK occupancy|ibrutinib Lead-in Day 6 or 7 pre-dose|All participants who received at least one dose of study treatment and had evaluable pharmacodynamics data.|||BTK % occupancy||Standard Error|Mean
2580890|NCT02401048|Secondary|Pharmacokinetics: MEDI4736 Accumulation Ratio for Ctrough|Accumulation ratio from Cycle 6 Day 1 to Cycle 1 Day 1 for Ctrough for MEDI4736|Cycle 6 Day 1 (predose)|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. Result data for both cohorts was pre-specified to be combined, and was not reported separately.|||ratio||Standard Deviation|Mean
2580891|NCT02401048|Secondary|Pharmacokinetics: MEDI4736 Accumulation Ratio for Cmax|Accumulation ratio from Cycle 6 Day 1 to Cycle 1 Day 1 for Cmax for MEDI4736|Cycle 6 Day 1 (collected 10 minutes after end of infusion)|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. Result data for both cohorts was pre-specified to be combined, and was not reported separately.|||ratio||Standard Deviation|Mean
2580892|NCT02401048|Secondary|Pharmacokinetics: Mean Trough Plasma Concentration (Ctrough) for MEDI4736|Trough plasma concentration of MEDI4736 on Cycle 6 Day 1 (ibrutinib + MEDI)|Cycle 6 Day 1 (predose)|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. Result data for both cohorts was pre-specified to be combined, and was not reported separately.|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2580893|NCT02401048|Secondary|Pharmacokinetics: Mean Peak Plasma Concentration (Cmax) for MEDI4736|Peak plasma concentration of MEDI4736 on Cycle 6 Day 1 (ibrutinib + MEDI)|Cycle 6 Day 1 (collected 10 minutes after end of infusion)|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data. Result data for both cohorts was pre-specified to be combined, and was not reported separately.|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2580894|NCT02401048|Secondary|Pharmacokinetics: Mean Terminal Elimination Half-Life (t1/2,Term) for Ibrutinib|Ibrutinib terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic plasma concentration-time curve, calculated as 0.693/λz on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI)|Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose)|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||hour||Standard Deviation|Mean
2581322|NCT02393950|Secondary|Effect of ODM-106 on Growth Hormone Levels|Growth hormone levels (Cmax) in serum after single oral dosing with either ODM-106 Capsule B, ODM-106 Capsule A or placebo.|Predose and 1, 2, 3,4, 6 and 8 hours post dose at each dose level.|Only timepoints 2 - 6h evaluated.|||ng/ml||Standard Deviation|Geometric Mean
2580895|NCT02401048|Secondary|Pharmacokinetics: Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC0-24h) for Ibrutinib|Ibrutinib AUC0-24h calculated using linear trapezoidal summation after dosing from time 0 to 24 hours on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI)|Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose)|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||ng*h/mL||Standard Deviation|Mean
2580896|NCT02401048|Secondary|Pharmacokinetics: Mean Time to Maximum Observed Plasma Concentration (Tmax) for Ibrutinib|Time to corresponding maximum observed plasma concentration of ibrutinib during the dosing interval on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI)|Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose)|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||hour||Full Range|Median
2580897|NCT02401048|Secondary|Phamacokinetics: Mean Maximum Observed Plasma Concentration (Cmax) for Ibrutinib|Maximum observed plasma concentration of ibrutinib during the dosing interval on Lead-In Day 6/7 (ibrutinib only) or Cycle 3 Day 1 (ibrutinib + MEDI)|Lead-In Day 6/7 or Cycle 3 Day 1 (collected at predose, 1, 2, 4, and 6 hours post-dose)|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||ng/mL||Standard Deviation|Mean
2580898|NCT02401048|Secondary|Phase 1b/2: Overall Survival||First dose date of study drug (ibrutinib or MEDI4736) to the date of death due to any cause||||Months||95% Confidence Interval|Median
2580899|NCT02401048|Secondary|Phase 1b/ 2: Progression-free Survival (PFS)||first dose date of study drug (ibrutinib or MEDI4736) to the first documentation of disease progression||||Months||95% Confidence Interval|Median
2580900|NCT02401048|Secondary|Phase 1b/ 2: Duration of Response||Time from the date of initial response to the date of disease progression or the date of death due to any cause, whichever occurs first.||||Months||95% Confidence Interval|Median
2580901|NCT02401048|Primary|Phase 1b/2 : Overall Response Rate of Number of Participants|The response criteria is measured based on the revised criteria for malignant lymphoma described by the International Working Group for NHL (Cheson 2014).|From the date of first study treatment until progressive disease|While the study include Phase 1b and 2, the dosing was not changed between phases (following the study design because there were no DLTs and thus no dose adjustments in from Phase 1b to Phase 2). Thus the study data were reported with Phases 1b and 2 combined.|||Participants|||Count of Participants
2580902|NCT02401022|Primary|Abstinence|The number of subjects in each treatment group who are smoking abstinence during the last 4 weeks of the treatment phase (weeks 10 through 13)|Weeks 10 - 13|Subjects who received at least one dose of AZD8529 were included in this population.|||Participants|||Count of Participants
2580903|NCT02400996|Primary|Nonfunctioning and Malignant Pancreatic Endocrine Neoplasms|Of the 40 patients operated for Pancreatic Endocrine Neoplasms, using clinical criteria, histopathological analysis and preoperative imaging as gold standard, nonfunctioning and functioning tumours were identified. Similarly the number of benign and malignant lesions identified were recorded as per the WHO Classification of pancreatic endocrine tumours.|Each participant was followed up for a period of 5 years||||participants|||Number
2580904|NCT02400905|Secondary|Stent Integrity (Measured as Freedom From Stent Fracture)|Stent integrity measured as freedom from stent fracture.|Months 12, 24 & 36|||||||
2580905|NCT02400905|Secondary|Functional Outcome (Walking Impairment Questionnaire)|Comparison of the Walking Impairment Questionnaire at Baseline, within 30 days after index procedure, then at Months 12 and 24.|Baseline, Day 30, Months 12 & 24|||||||
2580906|NCT02400905|Secondary|Functional Outcome (Ankle Brachial Index (ABI) Measurement)|Comparison of the ankle brachial index (ABI) measurement at Baseline, within 30 days after index procedure, then at Months 12 and 24.|Day 30, Months 12 & 24|||||||
2580907|NCT02400905|Secondary|Clinical Outcome (Six-Minute Walk Test)|Comparison of measured at Baseline, Day 30, Months 12 and 24 (subgroup of US investigational sites only).|Baseline, Day 30, Months 12 & 24|||||||
2580908|NCT02400905|Secondary|Clinical Outcome (Rutherford Clinical Category)|Comparison of Rutherford Clinical Category measured at Baseline, Day 30, Months 12 and 24.|Baseline, Day 30, Months 12 & 24|||||||
2580909|NCT02400905|Secondary|Primary Stent Patency|Determined at Months-12 and 24 using values of: PSVR >2.0, >2.4; >2.5; and >3.5, each to indicate loss of patency on duplex ultrasound or where angiography reveals >50% diameter stenosis or where the subject undergoes clinically-driven TLR.|Months 12 & 24|||||||
2580910|NCT02400905|Secondary|Technical Success|Percentage of subjects in which a final result of ≤50% residual diameter stenosis (in-stent) was achieved at index procedure|Procedural (at end of index procedure)|Subjects with available baseline angiography|||Participants|||Count of Participants
2580911|NCT02400905|Secondary|Long Term Safety (Overall Rate and Incidence of Type of Serious Adverse Events)|Overall rate and incidence of type of serious adverse events from Day 0 through completion of Study follow-up at Month 36.|36 Months|||||||
2580912|NCT02400905|Secondary|Long Term Safety (Overall MAE Rate at Month 12)|Overall MAE rate at Month 12 and contribution of individual event rates to the overall MAE.|12 months|Subjects are included in the analysis population if (i) they have sufficient follow-up (at least 12 months less 30 days), or (ii) they have had the event of interest (each event is considered separately).|||Participants|||Count of Participants
2580913|NCT02400905|Secondary|Secondary Safety (Overall MAE Rate at 30 Days)|Contribution of individual MAE rates for death, major amputation performed on the target limb and clinically-driven target lesion revascularization to the overall MAE rate at 30 days.|30 Days|Subjects with available 30 day follow-up|||Participants|||Count of Participants
2580914|NCT02400905|Primary|Primary Effectiveness Endpoint (Primary Stent Patency Rate)|Primary stent patency rate at 12 months.|12 months|Subjects were included in analysis population if they had imaging data qualifying as a 12m visit and/or subjects without imaging data who experienced a CDTLR through 12 months. Additionally, if a subject is missing stent patency status at the 12m window but found to be patent at a later out-of-window date, subject was considered patent at 12 months|||Participants|||Count of Participants
2580915|NCT02400905|Primary|Primary Safety Endpoint (Freedom From a Composite of Major Adverse Events (MAE)|Freedom from a composite of major adverse events (MAE) comprising death, any major amputation performed on the target limb or clinically-driven target lesion revascularization (TLR) through 30 days.|30 days|Subjects with available 30 day follow-up|||Participants|||Count of Participants
2580916|NCT02400749|Secondary|Palmoplantar Pustulosis Physician Global Assessment (PPPGA) of 0 or 1|"Number of patients who achieve a PPPGA of 0 or 1 at Week 32 for patients randomized to apremilast~The PPPGA is a zero to five, 6-point scale that evaluates the severity of palmoplantar psoriasis (score 0 [Clear]; score 1 [Almost clear]; score 2 [Mild]; score 3 [Moderate]; score 4 [Severe]; score 5 [Very severe])."|32 weeks||||Participants|||Count of Participants
2580917|NCT02400749|Secondary|Palmoplantar Psoriasis Area Severity Index (PPPASI)|"Change from baseline in PPPASI at Week 32 for patients randomized to apremilast~Palmoplantar psoriasis area severity index (PPPASI) is a scale that can vary from 0 to 72.~Erythema (E), induration (I), and desquamation (D) are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The combined score of each of these features, for the right (R) and left (L) palms and soles, gives a PPPASI score from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible).~PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole)"|32 weeks||||units on a scale||95% Confidence Interval|Mean
2580918|NCT02400749|Secondary|Palmoplantar Psoriasis Surface Area (PPPSA)|"Change from baseline in PPPSA at Week 16 for patients randomized to apremilast as compared to patients randomized to placebo~The surface affected by psoriasis on palms and soles is estimated as a percentage of the total surface of palms and soles. Each palm represents 20% and each sole 30%. PPPSA values range from 0% (no psoriasis on palms and soles) to 100% (all palms and soles covered by psoriasis)."|16 weeks||||units on a scale||Standard Deviation|Mean
2580919|NCT02400749|Secondary|Palmoplantar Psoriasis Area Severity Index (PPPASI)|"Change from baseline in PPPASI at Week 16 for patients randomized to apremilast as compared to patients randomized to placebo~Palmoplantar psoriasis area severity index (PPPASI) is a scale that can vary from 0 to 72.~Erythema (E), induration (I), and desquamation (D) are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The combined score of each of these features, for the right (R) and left (L) palms and soles, gives a PPPASI score from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible).~PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole)"|16 weeks||||units on a scale||Standard Deviation|Mean
2580920|NCT02400749|Secondary|Palmoplantar Psoriasis Physician Global Assessment (PPPGA)|"Change from baseline in mean PPPGA at Week 16 for patients randomized to apremilast as compared to patients randomized to placebo~The PPPGA is a zero to five, 6-point scale that evaluates the severity of palmoplantar psoriasis (score 0 [Clear]; score 1 [Almost clear]; score 2 [Mild]; score 3 [Moderate]; score 4 [Severe]; score 5 [Very severe])."|16 weeks||||units on a scale||Standard Deviation|Mean
2580921|NCT02400749|Primary|Palmoplantar Psoriasis Physician Global Assessment (PPPGA) of 0 or 1|"Number of patients who achieve a PPPGA of 0 or 1 at Week 16 for patients randomized to apremilast as compared to patients randomized to placebo~The PPPGA is a zero to five, 6-point scale that evaluates the severity of palmoplantar psoriasis (score 0 [Clear]; score 1 [Almost clear]; score 2 [Mild]; score 3 [Moderate]; score 4 [Severe]; score 5 [Very severe])."|16 weeks||||Participants|||Count of Participants
2580922|NCT02400710|Secondary|Engagement in PTSD Specialty Care as Measured by the Electronic Medical Record|Attendance of at least one session in the PTSD specialty clinic following the completion of the study intervention.|16 weeks||||participants|||Number
2580923|NCT02400710|Primary|PTSD Checklist-Specific|Measures the 17 symptoms of PTSD according to the DSM-IV. Each symptoms is measured on a 1-5 scale, with higher numbers indicated greater severity. The total range of the scale is 17-85.|8 weeks||||units on a scale||Standard Deviation|Mean
2580924|NCT02400580|Other Pre-specified|Nausea Before Surgery as Compared to After Surgery|A secondary aim of this study is to compare post-operative nausea on post-operative day zero and one as reported by the patients on a visual analog scale with a range of 0 to 10 where 0 is no nausea at all and 10 is the worst nausea that a person can imagine. Less nausea is considered preferable to more nausea. The hypothesis is that the intravenous acetaminophen group will experience decreased nausea compared with the placebo group.|24 hours||||units on a scale||95% Confidence Interval|Mean
2580925|NCT02400580|Other Pre-specified|Readiness for Discharge|Patient perception of satisfaction at time of discharge on post-operative day zero will be evaluated. The hypothesis is that intravenous acetaminophen group will experience increased satisfaction for discharge than the placebo group.|24 hours|Patients who were asked about overall satisfaction with procedure at time of discharge using a Visual Analog Scale. The scale has a range from 0 to 10 where a score of 0 would indicate the lowest (best) possible level of an outcome (pain, nausea etc) and a 10 would indicate the highest (worst) possible level.|||units on a scale||95% Confidence Interval|Mean
2580926|NCT02400580|Other Pre-specified|Number of Participants Who Vomited Within 24 Hours of Operation|A secondary aim of this study is to compare post-operative vomiting scores on post-operative day zero and one. Vomiting is reported as either having vomited or not vomited. The hypothesis is that the intravenous acetaminophen group will experience decreased vomiting compared with the placebo group.|24 hours||||Participants|||Count of Participants
2580927|NCT02400580|Other Pre-specified|Having a Feeling of General Well-being at One Month|Quality of recovery will be evaluated through the use of the validated Quality of Recovery-40 questionnaire. The hypothesis is that the intravenous acetaminophen group will experience an increased quality of recovery as compared to the placebo group.|4 weeks|The patients were asked to report their overall feeling of well being on a Visual Analog Scale one month after surgery. The scale has a range from 0 to 10 where a score of 0 would indicate the lowest (best) possible level of an outcome (pain, nausea etc) and a 10 would indicate the highest (worst) possible level.|||units on a scale||95% Confidence Interval|Mean
2580928|NCT02400580|Secondary|Narcotic Medication Use|The secondary outcome is comparison of narcotic pain medical requirements within the first 24 hours after surgery. The hypothesis is that the intravenous acetaminophen group will require less narcotic medications than the placebo group. Narcotic use in this study will be calculated by converting all narcotics (fentanyl, dilaudid etc) into standardized units of morphine using well validated conversion tables.|24 hours|This analysis is of the total number of units of morphine used by each group over a 24 hour period that is composed of the amount of narcotics received in the operating room, recovery room as well as at 6,12, and 24 hours postoperatively.|||Morphine Equivalents||95% Confidence Interval|Mean
2581879|NCT02387957|Primary|Total Numer of Systemic Adverse Events|Number of Patients with Systemic Adverse Events|2 years||||Participants|||Count of Participants
2580929|NCT02400580|Primary|Postoperative Pain|The primary aim of this study is to compare overall post-surgical pain after hysterectomy as reported by the patients on a visual analog scale with a range of 0 to 10 where 0 is no pain at all and 10 is the worst pain that a person can imagine. Less pain is considered preferable to more pain. The theory is that patients who have intravenous acetaminophen will report less post-surgical pain.|24 hours||||units on a visual analog scale||95% Confidence Interval|Mean
2580930|NCT02400346|Primary|Number of Patients With Treatment-Emergent Adverse Events|Treatment-emergent adverse event is an adverse event that started or increased in intensity at or after baseline visit|Baseline to 30 weeks||||Participants|||Count of Participants
2580931|NCT02400333|Secondary|Participants With Clinically Significant Findings in Hematology, Clinical Chemistry and Urinalysis.|Participants were assessed through each laboratory variables for any significant abnormalities. Hematology assessments included white blood cell count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin and others. Clinical chemistry assessment included testing levels of sodium, potassium, urea, creatinine, albumin, calcium, glucose (fasting) and others. Urinalysis assessment included glucose, protein, blood and microscopy (if positive for blood or protein).|At screening, at admission on Day -1 to each treatment period and at follow-up.|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.|||participants|||Number
2580932|NCT02400333|Secondary|Participants With Significant Findings in 12-Lead Electrocardiography (ECG).|A 12-lead ECG was obtained after the participant rested in supine position for at least 10 minutes. The study physician was to judge the overall interpretation as normal or abnormal. If abnormal, it was decided as to whether or not the abnormality was clinically significant and the reason for the abnormality was recorded.|At screening and at follow-up.|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.|||participants|||Number
2580933|NCT02400333|Secondary|Mean Change From Baseline for Vital Signs in Supine Pulse Rate.|Vital signs were collected after the participant has rested in the supine position for at least 5 minutes.|Day 1 (2, 4 hours post-dose) and Day 2 (24 hours post-dose).|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.|||bpm||Standard Deviation|Mean
2580934|NCT02400333|Secondary|Mean Change From Baseline for Vital Signs of Supine Blood Pressure (SBP) and Diastolic BP (DBP).|The following variables were collected after the participants had rested in the supine position for at least 5 minutes: SBP and DBP.|Day 1 (2, 4 hours post-dose) and Day 2 (24 hours post-dose).|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.|||mmHg||Standard Deviation|Mean
2580935|NCT02400333|Secondary|Percentage of Participants With Adverse Events (AEs).|An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. The term AE is used generally to include any AE whether serious or non-serious. A serious AE (SAE) is an AE that fulfills one or more of the following criteria: results in death, is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity or substantial disruption of the ability to conduct normal life functions; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.|SAEs were recorded from the signing of informed consent and AEs were recorded from randomisation until the final follow-up visit.|The safety analysis set included all participants who received at least one dose of ticagrelor and for whom any safety post-dose data were available.|||percentage of participants|||Number
2580936|NCT02400333|Secondary|Ratio of Metabolite AUC [0-∞] to Parent AUC [0-∞], Adjusted for Differences in Molecular Weights (MRAUC [0-∞]) of Metabolite AR-C124910XX.|Assesssment of MRAUC [0-∞] (Ratio of metabolite AUC [0-∞] to parent AUC [0-∞], adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2580937|NCT02400333|Secondary|Ratio of Metabolite AUC(0-t) to Parent AUC(0-t), Adjusted for Differences in Molecular Weights (MRAUC[0-t]) of Metabolite AR-C124910XX.|Assesssment of MRAUC(0-t) (Ratio of metabolite AUC(0-t) to parent AUC(0-t), adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2580938|NCT02400333|Secondary|Ratio of Metabolite Cmax to Parent Cmax, Adjusted for Differences in Molecular Weights (MRCmax) of Metabolite AR-C124910XX.|Assesssment of MRCmax (ratio of metabolite Cmax to parent Cmax, adjusted for differences in molecular weights) of ticagrelor and its active metabolite AR-C124910XX following single doses of the OD tablet when administered with water, without water and suspended in water to be administered through nasogastric tubes, compared to ticagrelor IR tablets.|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2581449|NCT02392351|Secondary|Significant Embolic Event Resulting in End-organ Damage or Intervention to Prevent it|Number of subjects experiencing a significant embolic event resulting in end-organ damage or intervention to prevent end-organ damage through 4 weeks.|4 weeks||||Participants|||Count of Participants
2580939|NCT02400333|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.|||h||Standard Deviation|Mean
2580940|NCT02400333|Secondary|Time to Reach Maximum Observed Concentration (Tmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.|||h||Full Range|Median
2580941|NCT02400333|Primary|Area Under Plasma Concentration-time Curve From Zero to Infinity (AUC [0-∞]).|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.|||h·ng/mL||Geometric Coefficient of Variation|Geometric Mean
2580942|NCT02400333|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration (AUC[0-t]) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The PK analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.|||h·ng/mL||Geometric Coefficient of Variation|Geometric Mean
2580943|NCT02400333|Primary|Maximum Observed Plasma Concentration (Cmax) of Ticagrelor and Its Active Metabolite AR-C124910XX.|Blood samples for the determination of plasma concentrations of both ticagrelor and AR-C124910XX were collected at pre-dose (0 hours) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours (14 samples per treatment period).|0 hours (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36 and 48 hours in each treatment period.|The Pharmacokinetic (PK) analysis set consisted of all participants in the safety analysis set for whom at least one of the primary PK parameters, for a given analyte, can be calculated for at least two treatment periods and who had no major protocol deviations.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2580944|NCT02400307|Secondary|Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities|A treatment-emergent graded laboratory abnormality was defined as an increase of at least 1 abnormality grade from the predose assessment and occurring after the predose visit and on or before the date of the administration of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant. Toxicity grade was defined as follows: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Life-threatening.|First dose date to Day 31|Participants in the Safety Analysis Set were analyzed.|||percentage of participants|||Number
2580945|NCT02400307|Secondary|Percentage of Participants Who Experienced Treatment-Emergent Adverse Events|Treatment-emergent adverse events (TEAEs) are defined as any adverse events (AEs) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug.|First dose date to Day 31|The Safety Analysis Set included participants who received the single dose of study drug.|||percentage of participants|||Number
2580946|NCT02400307|Primary|PK Parameter: Cmax of Bictegravir (Free)|Free Cmax was calculated based on unbound plasma bictegravir (Cmax × percentage unbound bictegravir ÷ 100 for each participant).|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1|Participants in the PK Analysis Set were analyzed.|||ng/mL||Standard Deviation|Mean
2580947|NCT02400307|Primary|PK Parameter: Cmax of Bictegravir (Total)|Cmax is defined as the maximum observed plasma concentration of drug.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1|Participants in the PK Analysis Set were analyzed.|||ng/mL||Standard Deviation|Mean
2580948|NCT02400307|Primary|PK Parameter: AUClast of Bictegravir (Free)|Free AUClast was calculated based on unbound plasma bictegravir (AUClast × percentage unbound bictegravir ÷ 100 for each participant).|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1|Participants in the PK Analysis Set were analyzed.|||h*ng/mL||Standard Deviation|Mean
2580949|NCT02400307|Primary|PK Parameter: AUClast of Bictegravir (Total)|AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1|Participants in the PK Analysis Set were analyzed.|||h*ng/mL||Standard Deviation|Mean
2580950|NCT02400307|Primary|PK Parameter: AUCinf of Bictegravir (Free)|Free AUCinf was calculated based on unbound plasma bictegravir (AUCinf × percentage unbound bictegravir ÷ 100 for each participant).|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1|Participants in the PK Analysis Set were analyzed.|||h*ng/mL||Standard Deviation|Mean
2581195|NCT02395666|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC)|"Pharmacokinetic assay AUC(0-6 hr)/D~Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different days"|0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose on two different days|12 subjects from both Stratum 1 and 2 were analyzed together as one group as per statistical analysis plan.|||hr*ng/mL||90% Confidence Interval|Mean
2580951|NCT02400307|Primary|Pharmacokinetic (PK) Parameter: AUCinf of Bictegravir (Total)|AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1|The PK Analysis Set included participants who took the single dose of bictegravir and had at least 1 nonmissing postdose concentration value for bictegravir.|||h*ng/mL||Standard Deviation|Mean
2580952|NCT02400073|Secondary|Sleep Changes Assessed Through Polysomnography|assessment of sleep quality (sleep efficacy, amounts of deep sleep, amounts of REM sleep). The outcome measure is changes in sleep from baseline at 3 months|3 months||||minutes||Standard Deviation|Mean
2580953|NCT02400073|Primary|Assessment of Quality of Life Using the Functional Outcomes of Sleep Questionnaire (FOSQ)|The Functional Outcomes of Sleep Questionnaire (FOSQ) assesses quality of life based on self reported physical and mental health. The outcome measure is Change from Baseline FOSQ score at 3 months. The minimum score is 5 and the maximum score is 20. Higher scores represent a better outcome|3 months||||score on a scale||Standard Deviation|Mean
2580954|NCT02399917|Secondary|Disease Free Survival|Disease Free Survival (DFS) is defined: Time from date of treatment start until the date of first objective documentation of disease-relapse|Up to 2.5 years|The outcome for the secondary response, disease free survival was only done on the Phase II portion of this study.|||Months||Full Range|Median
2580955|NCT02399917|Secondary|Overall Survival|Overall Survival (OS) is defined: Time of presentation to date of death or censored at last follow-up date.|Up to 2 years|The outcome for the secondary response, overall response was only done on the Phase II portion of this study.|||Months||Full Range|Median
2580956|NCT02399917|Secondary|Duration of Response|The date of Objective Response to the date of loss of response or last follow-up.|Up to 2.5 years|The outcome for the secondary response, duration of response was only done on the Phase II portion of this study.|||Months||Full Range|Median
2580957|NCT02399917|Primary|Participants With an Objective Response|Objective Response Rate (ORR) will be monitored using the Bayesian approach of Thall, Simon, Estey and the extension by Thall and Sung. Overall response rate (ORR), defined as complete remission (CR) + CR with incomplete platelet recovery (CRp) + CR with incomplete count recovery (CRi) + partial response (PR) + marrow clearance of blasts + hematological improvement within 3 months of treatment initiation among adult patients with refractory/relapsed Acute Myelogenous Leukemia (AML) (Phase II)|Up to 3 months||||Participants|||Count of Participants
2580958|NCT02399917|Primary|Maximum Tolerated Dose of Iirilumab in Combination With 5-azacitidine|To identify the dose at which <2/6 participants experience Dose Limiting Toxicities (DLT). The dose level at which 0-1/6 participants experience a DLT in the first 28 days of treatment will be the maximum tolerated dose (MTD) and would be used to treat an additional 34 participants in the phase II potion of the study. (Part A, Lead-In Phase)|Up to 28 days||||mg/kg|||Number
2580959|NCT02399345|Secondary|Percentage of Subjects With Post-treatment Relapse|Percentage of subjects with HCV RNA less than the lower limit of quantification at the end of treatment with confirmed HCV RNA greater than or equal to the lower limit of quantification through 12 weeks post treatment|Up to 12 weeks after last actual dose of active study drug|ITT population|||percentage of participants|||Number
2580960|NCT02399345|Secondary|Percentage of Subjects With On-treatment Virologic Failure|Virologic failure during treatment was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) during treatment; or failure to suppress during treatment (defined as all values of HCV RNA ≥ LLOQ during treatment).|6 weeks|ITT population|||percentage of participants|||Number
2580961|NCT02399345|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2580962|NCT02399254|Secondary|Activity-related Energy Expenditure (AEE)(J/Min/kg) at 48 Weeks|Investigators will look at changes in activity-related energy expenditure (from the DynaPort) at 48 weeks compared to baseline|48 weeks compared to baseline|Obtaining valid activity data (uploaded to the manufacturer then downloaded to the site) was a problem at all sites despite good support from the manufacturer. As a result a N of 10 could be analyzed at week 48.|||AEE (J/min/kg)||Standard Error|Mean
2580963|NCT02399254|Secondary|Activity-related Energy Expenditure (AEE)(J/Min/kg) at 12 Weeks|Investigators will look at changes in activity-related energy expenditure (from the DynaPort) at 12 weeks compared to baseline|12 weeks compared to baseline|Obtaining valid activity data (uploaded to the manufacturer then downloaded to the site) was a problem at all sites despite good support from the manufacturer. As a result a N of 16 could be analyzed at week 12.|||AEE (J/min/kg)||Standard Error|Mean
2580964|NCT02399254|Primary|Minutes/Day at 48 Weeks|Investigators will look at changes in directly-measured physical activity (minutes per day of walking activity from the DynaPort) between the 48 ± 3 week assessment and baseline.|48 weeks compared to baseline|Obtaining valid activity data (uploaded to the manufacturer then downloaded to the site) was a problem at all sites despite good support from the manufacturer. As a result a N of 10 could be analyzed at week 48.|||minutes/day||Standard Error|Mean
2580965|NCT02399254|Primary|Minutes/Day at 12 Weeks|Investigators will look at changes in directly-measured physical activity (minutes per day of walking activity from the DynaPort) between the 12 ± 3 week assessment and baseline.|12 weeks compared to baseline|Obtaining valid activity data (uploaded to the manufacturer then downloaded to the site) was a problem at all sites despite good support from the manufacturer. As a result a N of 16 could be analyzed at week 12.|||minutes/day||Standard Error|Mean
2580966|NCT02399163|Secondary|Change in Saliva Fluoride Concentration From Baseline (Post-treatment) to Day 14|Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample.|Baseline up to Day 14|PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.|||μg/mL||Standard Deviation|Mean
2580967|NCT02399163|Secondary|Change in Saliva Fluoride Concentration From Baseline (Pre-treatment) to Day 14|Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 baseline prior to supervised treatment. - at day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample.|Baseline to Day14|PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.|||microgram per mililitre(μg/mL )||Standard Deviation|Mean
2580968|NCT02399163|Secondary|Enamel Fluoride Uptake|The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2).|Baseline to 14 days|PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.|||microgram per square centimeter(μg/cm^2)||Standard Deviation|Mean
2580969|NCT02399163|Secondary|Percentage Surface Microhardness Recovery (SMHR) of Placebo Dentifrice/Fluoride Rinse, Placebo Dentifrice/No Rinse, Fluoride Dentifrice/No Rinse and Fluoride Dentifrice/Fluoride Rinse|SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline(B), indentation length (μm) after in vitro demineralization(D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B]*100.|Baseline to 14 days|PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.|||% SMHR||Standard Deviation|Mean
2580970|NCT02399163|Primary|Percentage Surface Microhardness Recovery (%SMHR) of Placebo Dentifrice/Fluoride Rinse Compared to Placebo Dentifrice/No Rinse|SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline(B), indentation length (μm) after in vitro demineralization(D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B]*100.|Baseline to 14 days|Per-protocol (PP) population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.|||% SMHR||Standard Deviation|Mean
2580971|NCT02399111|Secondary|Assess the Safety of the Devise by Monitoring Incidence of Bleeding , Seroma Formation|This study was terminated prior to collection of data.|30 days|||||||
2580972|NCT02399111|Primary|Incidence of Wound Infection With Szilagyi Grade|This study was terminated prior to gathering of data.|30 days|||||||
2580973|NCT02399085|Secondary|Percentage of Participants With Overall Survival (OS)|Overall survival was defined as first administration of IMP and deaths due to any cause. Percentage of patients alive at 12 months from the start of their study participation is reported.|Approximately 32 months between first patient first visit and primary outcome completion date|Overall survival was defined as first administration of IMP and deaths due to any cause. 80 of 81 patients enrolled in this study received MOR208 plus lenalidomide and represent efficacy set.|||Percentage of partipants|||Number
2580974|NCT02399085|Secondary|Progression-free Survival (PFS)|IRC Evaluation|1-3 years approximately|Progression-free survival (PFS) is defined as the time between first IMP dosing and tumour progression or death from any cause, whichever occurs first. 80 of 81 patients enrolled in this study received MOR208 plus lenalidomide and represent efficacy set.|||months||95% Confidence Interval|Median
2580975|NCT02399085|Secondary|Duration of Response (DoR)|IRC Evaluation|1-3 years approximately|Duration of response (DoR) is defined as the time between the first response (CR or PR) and the first time point of radiologically confirmed disease progression. 80 of 81 patients enrolled in this study received MOR208 plus lenalidomide and represent efficacy set.|||months||95% Confidence Interval|Median
2580976|NCT02399085|Secondary|Disease Control Rate (DCR)|DCR = CR + PR + SD; IRC Evaluation|1-3 years approximately|Disease control rate (DCR) is defined as the proportion of patients having CR or PR or stable disease (SD) (DCR = ORR + SD). 80 of 81 patients enrolled in this study received MOR208 plus lenalidomide and represent efficacy set.|||Participants|||Count of Participants
2580977|NCT02399085|Primary|Number of Participants With Best Objective Response Rate|ORR = complete response [CR] + partial response [PR]; IRC Evaluation|1-3 years approximately|Response Criteria are based on International Working Group Response Criteria: Complete Response (CR), Disappearance of all evidence of disease; Partial Response (PR), >=50% regression of measurable disease and no new sites. 80 of 81 patients enrolled in this study received MOR208 plus lenalidomide and represent efficacy set.|||Participants|||Count of Participants
2580978|NCT02398227|Primary|Severity of Violence Against Women Scale (SVAWS)|Severity of Violence Against Women Scale total score. Scores can range from 0 to 138 with higher scores reflecting greater degree of violence/abuse.Adjusted means with baseline scores as a covariate are reported|baseline, post-shelter, post-treatment, 6-month post-treatment, 1 year post-treatment|Analysis only include those who completed all time-points|||score on a scale||Standard Deviation|Mean
2581323|NCT02393950|Secondary|Metabolite Screening in Plasma and Urine|Metabolite screening in plasma and urine after single dosing|Plasma samples at pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine samples, pre-dose and for 24 hours post dose at each dose level|||||||
2580979|NCT02398227|Primary|Clinician Administered PTSD Scale (CAPS)|Clinical Interview assessing symptoms of Posttraumatic Stress Disorder (PTSD) scores can range from 0 to 136 with higher scores reflecting greater PTSD severity Adjusted means with baseline scores as a covariate are reported|baseline, post-shelter, post-treatment, 6 months post-treatment, 1 year post-treatment|Analysis include those participants who completed each follow-up time point.|||units on a scale||Standard Deviation|Mean
2580980|NCT02398188|Secondary|Percent Change in Waist Circumference||8 weeks post the start of treatment||||percent change||Standard Deviation|Mean
2580981|NCT02398188|Primary|Percent Change in the Patient Reported Global Abdominal Perception Score|1 equals much improved, 7 equals much worse. The higher the scores the worse the outcome.|8 weeks post the start of treatment||||percent change||Standard Deviation|Mean
2580982|NCT02398188|Primary|Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response|"The composite P-GAPS1/CPnS2 response was defined as at least a 1 point (grade) improvement in P-GAPS and at least a 2 point (grade) improvement in CPnS from baseline after 8 weeks of treatment.~Patient - Global Abdominal Perception Scale (P-GAPS) - a patient views and assesses the contour of their abdomen on a 5-point verbal scale ranging from Flat to Big Bulge.~Clinician Photonumeric Scale (CPnS) - a trained clinician rater examines the subject's abdomen and matches the subject's abdominal bulge/profile to the nearest gender-specific abdominal photo on the 6-point scale."|Baseline and End of Study (1 week post last treatment, 9 weeks after first treatment)|ITT Population|||Participants|||Count of Participants
2580983|NCT02397954|Other Pre-specified|Regression and/or Elimination of Polyps at Month 3|Regression and/or Elimination of Polyps from baseline to Month 3|Baseline and Month 3||||Polyps|||Number
2580984|NCT02397954|Other Pre-specified|Mean Change in Central Subfield Retinal Thickness (SD-OCT) From Baseline at Month 3|Mean change in central subfield retinal thickness from baseline at Month 3 as measured by SD-OCT|Baseline and Month 3|Limited sample size; all study participants were included in the analysis.|||μm||Full Range|Mean
2580985|NCT02397954|Primary|Number of Participants With Systemic Adverse Events|Number of Participants with Systemic Adverse Events (with calculated percentage)|3 months||||Participants|||Count of Participants
2580986|NCT02397954|Primary|Number of Participants With Ophthalmic Adverse Events|Number of Participants with Ophthalmic Adverse Events (with calculated percentage)|3 months||||Participants|||Count of Participants
2580987|NCT02397954|Primary|Number of Participants With >15 ETDRS Letter Loss at Month 3|Number of participants with >15 ETDRS letter loss (with calculated percentage)|3 Months||||Participants|||Count of Participants
2580988|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed|"Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 12, How likely to comply if prescribed? are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very likely; 1: moderately likely; 2: somewhat likely; 3: neither likely nor unlikely; 4: somewhat unlikely; 5; moderately unlikely; 6: very unlikely. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method."|Approximatly two minutes after the dosing in Period 1 and 2|PP Population|||Participants|||Number
2580989|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product.|"Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 11, How satisfied with product? are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method."|Approximatly two minutes after the dosing in Period 1 and 2|PP Population|||Participants|||Number
2580990|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation.|"Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 10, How bothersome was nasal irritation? are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method."|Approximatly two minutes after the dosing in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.|||Participants|||Number
2581019|NCT02397837|Primary|MATRICS Consensus Cognitive Battery|MATRICS Consensus Cognitive Battery (MCCB) as measure of Neurocognitive/Functional Measures is a standardized battery designed to measure cognitive functioning in people with schizophrenia. The MCCB is represented as a composite T score. This T-score scale has a mean of 50 and a standard deviation of 10, where higher scores reflect better performance.|Week 6|The discrepancy in participants analyzed here compared to baseline is due to an early termination from study of 5 participants in pramipexole group and 4 participants in placebo group.|||T-score||Standard Deviation|Mean
2581324|NCT02393950|Secondary|Elimination Half-life of ODM-106|Elimination half-life of ODM-106 after single dosing of either Capsule B or Capsule A|Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.||||h||Standard Deviation|Mean
2580991|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation.|"Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 9, Did product cause nasal irritation? are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method."|Approximatly two minutes after the dosing in Period 1 and 2|PP Population|||Participants|||Number
2580992|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Soothing.|"Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 8, Did product feel soothing? are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method."|Approximatly two minutes after the dosing in Period 1 and 2|PP Population|||Participants|||Number
2580993|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose.|"Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 7, Did medicine run out of nose? are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method."|Approximatly two minutes after the dosing in Period 1 and 2|PP Population|||Participants|||Number
2580994|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat.|"Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 6, Did medicine run down throat? are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method."|Approximatly two minutes after the dosing in Period 1 and 2|PP Population|||Participants|||Number
2580995|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste.|"Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 5, How satisfied with aftertaste? are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and BL rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method."|Approximatly two minutes after the dosing in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.|||Participants|||Number
2580996|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste.|"Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 4, Did product have an aftertaste? are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method."|Approximatly two minutes after the dosing in Period 1 and 2|PP Population|||Participants|||Number
2581020|NCT02397837|Primary|MATRICS Consensus Cognitive Battery|MATRICS Consensus Cognitive Battery (MCCB) as measure of Neurocognitive/Functional Measures is a standardized battery designed to measure cognitive functioning in people with schizophrenia. The MCCB is represented as a composite T score. This T-score scale has a mean of 50 and a standard deviation of 10, where higher scores reflect better performance.|Baseline||||T-score||Standard Deviation|Mean
2581325|NCT02393950|Secondary|Time to Peak Plasma Concentration (Tmax) of ODM-106|tmax of ODM-106 after single oral dosing of Capsule B or Capsule A|Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level||||h||Full Range|Mean
2580997|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor.|"Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using delayed attributes questionnaire, Question 3, How satisfied not to have scent/odor? are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method."|Approximatly two minutes after the dosing in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.|||Participants|||Number
2580998|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor.|"Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using delayed attributes questionnaire, Question 2, How satisfied with scent/odor? are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method."|Approximatly two minutes after the dosing in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.|||Participants|||Number
2580999|NCT02397915|Secondary|Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor.|"Delayed attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. scent/odor, using delayed attributes questionnaire, Question 1, Did product have a scent/odor? are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method."|Approximatly two minutes after the dosing in Period 1 and 2|PP Population|||Participants|||Number
2581000|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing|"Immediate attributes questionnaire was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes using immediate attributes questionnaire, Question 9, Did product make want to sneeze? are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no urgency; 1: very slightly urgency; 2: slightly urgency; 3: neither slightly nor moderately urgency; 4: moderately urgency; 5; markedly urgency; 6: very markedly urgency. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and BL rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method."|Immediately following each treatment in Period 1 and 2|PP Population|||Participants|||Number
2581001|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Soothing|"Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using immediate attributes questionnaire, Question 8, Did product feel soothing? are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method."|Immediately following each treatment in Period 1 and 2|PP Population|||Participants|||Number
2581002|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose.|"Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using immediate attributes questionnaire, Question 7, Did medicine run out of nose? are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method."|Immediately following each treatment in Period 1 and 2|PP Population|||Participants|||Number
2581021|NCT02397785|Secondary|Change From Baseline in Weekly Opioid Use|Patients were asked to record weekly doses of over-the-counter pain medications taken, including ibuprofen (mg), naprosyn (mg), acetaminophen (mg), and opioids (calculated morphine equivalents). Change = (Week 12 total - Week 1 total).|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||morphine equivalents/week||Standard Deviation|Mean
2581003|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat|"Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using immediate attributes questionnaire, Question 6, Did medicine run down throat? are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method."|Immediately following each treatment in Period 1 and 2|PP Population|||Participants|||Number
2581004|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste.|"Immediate attributes questionnaire was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. taste, using immediate attributes questionnaire, Question 5, How satisfied with immediate taste? are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and BL rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method."|Immediately following each treatment in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.|||Participants|||Number
2581005|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste.|"Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. taste, using immediate attributes questionnaire, Question 4, Did product have an immediate taste? are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method."|Immediately following each treatment in Period 1 and 2|PP Population|||Participants|||Number
2581006|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor|"Immediate attributes questionnaire was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using immediate attributes questionnaire, Question 3, How satisfied not to have scent/odor? are summarized. The immediate' attributes questionnaire was completed immediately following each trt in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, trt, period, and BL rhinitis symptomatology subgroup, and trt sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method."|Immediately following each treatment in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.|||Participants|||Number
2581007|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor|"Immediate attributes questionnaire (ques) was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using immediate attributes ques, Question 2, How satisfied with scent/odor? are summarized. The immediate' attributes ques was completed immediately following each treatment (trt) in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, trt, period, and BL rhinitis symptomatology subgroup, and trt sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method."|Immediately following each treatment in Period 1 and 2|PP Population. Only participants responded to the question were analyzed.|||Participants|||Number
2581008|NCT02397915|Secondary|Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor|"Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. scent/odor, using immediate attributes questionnaire, Question 1, Did product have a scent/odor? are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Immediate attribute ratings were analyzed using an analysis of variance (ANOVA) mixed model with participant as a random effect, and country, treatment, period, and Baseline (BL) rhinitis symptomatology subgroup (subgrp), and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method."|Immediately following each treatment in Period 1 and 2|PP Population|||Participants|||Number
2581326|NCT02393950|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of ODM-106|AUC of ODM-106 after single oral dosing of either Capsule B or Capsule A.|Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine sampling, pre-dose and for 24 hours post dose at each dose level||||h*ng/ml||Standard Deviation|Mean
2581009|NCT02397915|Secondary|Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire|An overall preference questionnaire (OPQ) was used to evaluate participants' attribute preference for nasal spray therapy for the given treatment. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1; preference for product 2 and no preference. Products attributes included scent/odor, immediate taste, after taste, less drip through throat (LDTT), less run out of nose (LRON), more soothing, less irritating and urge to sneeze (UTS). The OPQ was completed by each participant approximately 4 minutes after administration of the second treatment (tmt) in Period 2. Overall participant preferences were analyzed using Prescott's test, as approximated by a Cochran-Mantel-Haenszel (CMH) test, adjusted for country (ctry) and symptomatology (sym). All preference p-values were also adjusted for multiplicity using Hochberg's method.|Approximately four minutes after the administration of the second treatment|PP Population|||Participants|||Number
2581010|NCT02397915|Primary|Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire.|An overall preference questionnaire (OPQ) was used to evaluate participants' preference for nasal spray therapy for the given treatments. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1; preference for product 2 and no preference. The OPQ was completed by each participant approximately 4 minutes after administration of the second treatment in Period 2. Overall participant preferences were analyzed using Prescott's test, as approximated by a Cochran-Mantel-Haenszel (CMH) test, adjusted for country and symptomatology. All preference p-values were also adjusted for multiplicity using Hochberg's method.|Approximately four minutes after the administration of the second treatment|Per Protocol (PP) Population: comprised of all participants who completed both treatment Periods and the questionnaires associated with them.|||Participants|||Number
2581011|NCT02397837|Secondary|The Probabilistic Stimulus Selection Task|"The probabilistic selection task assesses the tendency to learn from positive versus negative outcomes. In the probabilistic stimulus selection task, participants are trained to choose one of two paired stimuli; three sets of paired stimuli are shown in total (AB, CD, and EF) and are presented randomly during the training period. To minimize verbal encoding, stimuli are Japanese Hiragana characters. Probabilistic feedback regarding the correct choice is provided. We report the mean percentage of accuracy on choosing the correct paired stimuli among the two treatment groups."|Week 12|The discrepancy in participants analyzed from participants in Participant Flow is due to availability of data because of software issues in running task.|||percentage of accuracy||Standard Deviation|Mean
2581012|NCT02397837|Secondary|The Probabilistic Stimulus Selection Task|"The probabilistic selection task assesses the tendency to learn from positive versus negative outcomes. In the probabilistic stimulus selection task, participants are trained to choose one of two paired stimuli; three sets of paired stimuli are shown in total (AB, CD, and EF) and are presented randomly during the training period. To minimize verbal encoding, stimuli are Japanese Hiragana characters. Probabilistic feedback regarding the correct choice is provided. We report the mean percentage of accuracy on choosing the correct paired stimuli among the two treatment groups."|Week 6|The discrepancy in participants analyzed from participants in Participant Flow is due to availability of data because of software issues in running task.|||percentage of accuracy||Standard Deviation|Mean
2581013|NCT02397837|Secondary|The Probabilistic Stimulus Selection Task|"The probabilistic selection task assesses the tendency to learn from positive versus negative outcomes. In the probabilistic stimulus selection task, participants are trained to choose one of two paired stimuli; three sets of paired stimuli are shown in total (AB, CD, and EF) and are presented randomly during the training period. To minimize verbal encoding, stimuli are Japanese Hiragana characters. Probabilistic feedback regarding the correct choice is provided. We report the mean percentage of accuracy on choosing the correct paired stimuli among the two treatment groups."|Baseline|The discrepancy in participants analyzed from participants in Participant Flow is due to availability of data because of software issues in running task.|||percentage of accuracy||Standard Deviation|Mean
2581014|NCT02397837|Secondary|Number of Participants With Suicidal Acknowledgements|Number of individual participants who acknowledged at least one item on the Columbia Suicide Severity Rating Scale (C-SSRS) over the 12-week study period. Examples of items on the scale are suicidal ideation (having thoughts, planning) and suicidal behavior (preparing, attempting).|up to Week 12||||Participants|||Count of Participants
2581015|NCT02397837|Secondary|Brief Psychiatric Rating Scale (BPRS)|Mean change for positive symptoms throughout the study. BPRS consists of 18 items, each defined by a series of symptoms. Each item is rated on a 7-point scale, ranging from 1 (not observed) to 7 (very severe), with a total score range from 18-126, where higher scores indicate psychiatric symptoms.|Baseline and week 12|Average change in BPRS based on baseline and week 12 score.The discrepancy in participants analyzed here compared to participant flow is due to available data.|||score on a scale||Standard Deviation|Mean
2581016|NCT02397837|Secondary|Hamilton Rating Scale for Depression (HRSD)|Mean change of symptoms of depression throughout the study. HRSD consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe), with a total score range of 0-56, where higher score indicates more depressive symptoms.|Baseline and week 12|Average change in HRSD based on baseline and week 12 score.|||score on a scale||Standard Deviation|Mean
2581017|NCT02397837|Secondary|Young Mania Rating Scale (YMRS)|Mean change of symptoms of mania throughout the study. YMRS contains 7 items rated from 0 (symptom absent) to 4 (severe symptom) and 4 items scored 0 (symptom absent) to 8 (severe symptom), with total range from 0 to 60, where higher score indicates manic symptoms.|Baseline and week 12|Average change in YMRS based on baseline and week 12 score.|||score on a scale||Standard Deviation|Mean
2581018|NCT02397837|Primary|MATRICS Consensus Cognitive Battery|MATRICS Consensus Cognitive Battery (MCCB) as measure of Neurocognitive/Functional Measures is a standardized battery designed to measure cognitive functioning in people with schizophrenia. The MCCB is represented as a composite T score. This T-score scale has a mean of 50 and a standard deviation of 10, where higher scores reflect better performance.|Week 12||||T-score||Standard Deviation|Mean
2581022|NCT02397785|Secondary|Change From Baseline in Weekly Acetaminophen Use|Patients were asked to record weekly doses of over-the-counter pain medications taken, including ibuprofen (mg), naprosyn (mg), acetaminophen (mg), and opioids (calculated morphine equivalents). Change = (Week 12 total - Week 1 total).|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||mg/week||Standard Deviation|Mean
2581023|NCT02397785|Secondary|Change From Baseline in Weekly Naprosyn Use|Patients were asked to record weekly doses of over-the-counter pain medications taken, including ibuprofen (mg), naprosyn (mg), acetaminophen (mg), and opioids (calculated morphine equivalents). Change = (Week 12 total - Week 1 total).|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 medication diaries available.|||mg/week||Standard Deviation|Mean
2581024|NCT02397785|Secondary|Change From Baseline in Weekly Ibuprofen Use|Patients were asked to record weekly doses of over-the-counter pain medications taken, including ibuprofen (mg), naprosyn (mg), acetaminophen (mg), and opioids (calculated morphine equivalents). Change = (Week 12 total - Week 1 total).|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 medication diaries available.|||mg/week||Standard Deviation|Mean
2581025|NCT02397785|Secondary|Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Total Scale|The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). Change = (Week 12 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 PFDI scores available.|||units on a scale||Standard Deviation|Mean
2581026|NCT02397785|Secondary|Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Urinary Distress Inventory (UDI) Sub-Scale|The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). Change = (Week 12 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 PFDI scores available.|||units on a scale||Standard Deviation|Mean
2581027|NCT02397785|Secondary|Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Colorectal Anal Distress Inventory (CRADI) Sub-Scale|The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). Change = (Week 12 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 PFDI scores available.|||units on a scale||Standard Deviation|Mean
2581028|NCT02397785|Secondary|Change From Baseline in Quality of Life on Pelvic Floor Distress Inventory (PFDI) Pelvic Organ Prolapse Distress Inventory (POPDI) Sub-Scale|The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). Change = (Week 12 Score - Baseline Score). Lower scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 PFDI scores available.|||units on a scale||Standard Deviation|Mean
2581029|NCT02397785|Secondary|Change From Baseline in Quality of Life on Female Sexual Function Index (FSFI) Scale|The Female Sexual Function Index is a validated, self-reported instrument used to evaluate sexual function and symptoms. The FSFI consists of 6 sub-scales: 1) desire [score range = 1.2 - 6], 2) arousal [score range = 0 - 6], 3) lubrication [score range = 0 - 6], 4) orgasm [score range = 0 - 6], 5) satisfaction [score range = 0 - 6], 6) pain [score range = 0 - 6]. The full FSFI consists of 19 questions, and the total score ranges from 1.2 - 36. Change = (Week 12 Score - Baseline Score). Higher scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 FSFI scores available.|||units on a scale||Standard Deviation|Mean
2581030|NCT02397785|Secondary|Change From Baseline in Pain on Brief Pain Inventory (BPI) Pain Interference Scale|The Brief Pain Inventory (BPI) is a validated, self-reported instrument used to evaluate pain symptoms within the last 24 hours. The BPI consists of 2 sub-scales: 1) pain severity, 2) pain interference. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-10. Lower scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 BPI scores available.|||units on a scale||Standard Deviation|Mean
2581031|NCT02397785|Secondary|Change From Baseline in Pain on Brief Pain Inventory (BPI) Pain Severity Scale|The Brief Pain Inventory (BPI) is a validated, self-reported instrument used to evaluate pain symptoms within the last 24 hours. The BPI consists of 2 sub-scales: 1) pain severity, 2) pain interference. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-10. Lower scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 BPI scores available.|||units on a scale||Standard Deviation|Mean
2581032|NCT02397785|Secondary|Change From Baseline in Quality of Life on Short Form 36 (SF-36) General Health Scale|Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||units on a scale||Standard Deviation|Mean
2581135|NCT02396420|Secondary|Change From Baseline in Detrusor Muscle Pressure (Pdet) as Determined by Urodynamic Testing|Detrusor muscle pressure (Pdet) is important when evaluating how strong the detrusor force must be to initiate urine flow in bladder outlet obstruction. Lower Pdet values are associated with a positive response to treatment.|12 Months|The one subject who completed the study thru Visit 5 refused to undergo urodynamic testing at Visit 5. As a result the Pdet was not obtained. This was reported as a protocol deviation in the study.||||||
2581033|NCT02397785|Secondary|Change From Baseline in Pain on Short Form 36 (SF-36) Pain Scale|Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||units on a scale||Standard Deviation|Mean
2581034|NCT02397785|Secondary|Change From Baseline in Quality of Life on Short Form 36 (SF-36) Social Function Scale|Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||units on a scale||Standard Deviation|Mean
2581035|NCT02397785|Secondary|Change From Baseline in Quality of Life on Short Form 36 (SF-36) Emotional Wellbeing Scale|Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||units on a scale||Standard Deviation|Mean
2581036|NCT02397785|Secondary|Change From Baseline in Quality of Life on Short Form 36 (SF-36) Energy/Fatigue Scale|Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||units on a scale||Standard Deviation|Mean
2581037|NCT02397785|Secondary|Change From Baseline in Quality of Life on Short Form 36 (SF-36) Role Limitations Due to Emotional Problems Scale|Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||units on a scale||Standard Deviation|Mean
2581038|NCT02397785|Secondary|Change From Baseline in Quality of Life on Short Form 36 (SF-36) Role Limitations Due to Physical Health Scale|Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||units on a scale||Standard Deviation|Mean
2581039|NCT02397785|Secondary|Change From Baseline in Quality of Life on Short Form 36 (SF-36) Physical Functioning Scale|Short Form-36 is a validated, self-reported instrument used to evaluate overall quality of life. The SF-36 consists of 8 sub-scales: 1) physical functioning, 2) role limitations due to physical health, 3) role limitations due to emotional problems, 4) energy/fatigue, 5) emotional well-being, 6) social functioning, 7) pain, 8) general health. Change = (Week 12 Score - Baseline Score). Scores for each sub-scale range from 0-100. Higher scores indicate better function / fewer symptoms.|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 SF-36 scores available.|||units on a scale||Standard Deviation|Mean
2581040|NCT02397785|Primary|Change From Baseline in Pain on the Visual Analog Scale (VAS) at Week 12|"The Visual Analog Scale assesses self-reported pain scores. Patients were asked to record their average pain over the past 4 weeks by placing an X on a 10-cm line, with 0 representing no pain and 100 representing the worst pain imaginable. Pain scores were determined by research personnel by measuring the distance (in mm) from 0 to the X. Change = (Week 12 Score - Baseline Score)."|Baseline and Week 12|Based on the intention-to-treat population. All participants with Baseline and Week 12 VAS scores available.|||units on a scale||Standard Deviation|Mean
2581041|NCT02397707|Primary|PK Parameter of Voxilaprevir: Cmax|Cmax is defined as the maximum observed plasma concentration of drug.Data presented are unadjusted geometric means and confidence intervals.|0 (pre-dose ≤ 5 minutes), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose|Participants in the PK Analysis Set were analyzed. Five of the same participants with normal hepatic function served as matched controls for the MHI and SHI Arms/Groups.|||ng/mL||95% Confidence Interval|Geometric Mean
2581042|NCT02397707|Primary|PK Parameter of Voxilaprevir: AUCinf|AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time. Data presented are unadjusted geometric means and confidence intervals.|0 (pre-dose ≤ 5 minutes), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose|Participants in the PK Analysis Set were analyzed. Five of the same participants with normal hepatic function served as matched controls for the MHI and SHI Arms/Groups.|||h*ng/mL||95% Confidence Interval|Geometric Mean
2581174|NCT02396147|Secondary|Terminal Phase Elimination Half-Life (T1/2) for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.|||hours||Standard Deviation|Mean
2581043|NCT02397707|Primary|Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast|AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration. Data presented are unadjusted geometric means and confidence intervals.|0 (pre-dose ≤ 5 minutes), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours post-dose|PK Analysis Set included all enrolled participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose concentration value reported by the PK laboratory for the corresponding analyte. Five of the same participants with normal hepatic function served as matched controls for the MHI and SHI Arms/Groups.|||h*ng/mL||95% Confidence Interval|Geometric Mean
2581044|NCT02397694|Secondary|PK Parameter: t1/2 of BIC, FTC, TAF, and TFV|t1/2 was defined as the terminal elimination half-life of the drug|0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8|Participants in the PK Substudy Analysis Set were analyzed.|||hours||Inter-Quartile Range|Median
2581045|NCT02397694|Secondary|PK Parameter: AUCtau for BIC, FTC, TAF, and TFV|AUCtau is defined as the area under the concentration-time curve of the drug over time.|0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8|Participants in the PK Substudy Analysis Set were analyzed.|||h*ng/mL||Standard Deviation|Mean
2581046|NCT02397694|Secondary|PK Parameter:Ctau for BIC, FTC and TFV|Ctau was defined as the observed drug concentration at the end of the dosing interval.|0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8|Participants in the PK Substudy Analysis Set were analyzed.|||ng/mL||Standard Deviation|Mean
2581047|NCT02397694|Secondary|PK Parameter: Tmax for BIC, FTC, TAF, and TFV at Steady-State|Tmax was defined as the time to Cmax.|0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8|Participants in the PK Substudy Analysis Set were analyzed.|||hours||Inter-Quartile Range|Median
2581048|NCT02397694|Secondary|PK Parameter: Cmax for Bictegravir (BIC), Emtricitabine (FTC), Tenofovir Alafenamide (TAF) and Tenofavir (TFV) at Steady-State|Cmax is the maximum observed plasma concentration of the drug.|0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours postdose at Week 4 or 8|Pharmacokinetic (PK) Substudy Analysis Set included all participants who (1) were randomized into the double-blinded phase of study, (2) were enrolled into the PK substudy, (3) received at least 1 dose of study drug during the double-blinded phase, and (4) had at least 1 nonmissing intensive PK concentration value.|||ng/mL||Standard Deviation|Mean
2581049|NCT02397694|Secondary|Percentage of Participants With Treatment Emergent Laboratory Abnormalities During Double-Blind Randomized Phase||First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)|Participants in the Safety Analysis Set were analyzed.|||percentage of participants|||Number
2581050|NCT02397694|Secondary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) During Double-Blinded Randomized Phase||First dose date up to last dose (maximum duration: 58 Weeks) plus 30 days (During Double-Blinded Randomized Phase)|Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2581051|NCT02397694|Secondary|The Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||CD4 Cell Count (/μL)||Standard Deviation|Mean
2581052|NCT02397694|Secondary|The Change From Baseline in CD4+ Cell Count at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.|||CD4 Cell Count (/μL)||Standard Deviation|Mean
2581053|NCT02397694|Secondary|The Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 12||Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.|||CD4 Cell Count (/μL)||Standard Deviation|Mean
2581054|NCT02397694|Secondary|The Change From Baseline in log10 HIV-1 RNA at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2581055|NCT02397694|Secondary|The Change From Baseline in log10 HIV-1 RNA at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2581056|NCT02397694|Secondary|The Change From Baseline in log10 HIV-1 RNA at Week 12||Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2581057|NCT02397694|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2581058|NCT02397694|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm at Week 12|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 12|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2581059|NCT02397694|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL as Determined by the FDA-defined Snapshot Algorithm.|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set included all participants who were randomized into the double-blinded phase of study and received at least 1 dose of study drug during the double-blinded phase.|||percentage of participants|||Number
2581071|NCT02397473|Secondary|Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)|PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, baseline cluster headache attack category, month, and treatment by month as fixed effects.|Week 4|All randomized participants who received at least one dose of study drug and had PGI-I measurement at week4.|||percentage of participants|||Number
2581060|NCT02397655|Primary|Evidence of Carotid Artery or Intracranial Artery Atherosclerosis Confirmed by Vascular Ultrasonography|"By using color doppler ultrasonography, the common carotid after, internal carotid artery, vertebral artery and subclavian artery stenosis were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, <50% stenosis, 50-69% stenosis 70-99% stenosis and occlusion.~By using transcranial color-coded sonography (TCCS) and/or transcranial doppler, the middle cerebral artery, the V4 segment of vertebral artery and basilar artery were examined and the stenosis degree of these arteries were evaluated and categorized as no stenosis, mild stenosis, medium stenosis , severe stenosis and occlusion.~Patients with one of the above arteries having >50% stenosis or occlusion evaluated by ultrasound were underwent CTA, MRA or DSA to confirmed the stenosis degree."|30 days after subjects recruitment|We provide the vessel numbers with its stenosis degree ≥50% stenosis (including occlusion).|||artery numbers|||Number
2581061|NCT02397564|Secondary|Patient Preference|The number of patients who preferred the fractionated laser|5 months|Those who expressed a preference.|||Participants|||Count of Participants
2581062|NCT02397564|Primary|Patient Observer Scar Assessment Scale (POSAS)|It uses a 10-point scoring system with a score of 1 representing a normal-appearing skin and a score of 10 representing the worst possible scar. Total scores range from 6 to 60 with the lower score indicate a better outcome.|5 months||||units on a scale||Standard Error|Mean
2581063|NCT02397473|Secondary|Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)|"C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide."|Month 1 through Month 6|All randomized participants who received at least one dose of study drug and had at least one post baseline C-SSRS assessment.|||percentage of participants|||Number
2581064|NCT02397473|Secondary|Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)|"C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal ideation: a yes answer to any of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent."|Month 1 through Month 6|All randomized participants who received at least one dose of study drug and had at least one post baseline C-SSRS assessment.|||percentage of participants|||Number
2581065|NCT02397473|Secondary|Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab|Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject has at least one post-baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post-baseline result of ADA present with titer >= 1: 20.|Baseline through Week 8|All randomized participants who received at least one dose of study drug and had non-missing baseline ADA result, and at least one non-missing post baseline ADA result.|||percentage of participants|||Number
2581066|NCT02397473|Secondary|Pharmacokinetics (PK): Serum Concentration of Galcanezumab||Week 8|All randomized participants who received at least one dose of study drug and had measurable PK samples.|||Nanogram per Milliliter (ng/mL)||Standard Deviation|Mean
2581067|NCT02397473|Secondary|Pharmacokinetics (PK): Serum Concentration of Galcanezumab||Week 4|All randomized participants who received at least one dose of study drug and had measurable PK samples.|||Nanogram per Milliliter (ng/mL)||Standard Deviation|Mean
2581068|NCT02397473|Secondary|Percentage of Participants With 30% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks|Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Mean percentage of participants is derived from the average of weeks 1 to 8 from generalized linear mixed model repeated measures with treatment, sex, week, treatment by week and baseline as fixed effects.|Baseline, Week 1 through Week 8|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.|||percentage of participants|||Number
2581069|NCT02397473|Secondary|Percentage of Participants With 50% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks|Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Mean percentage of participants is derived from the average of weeks 1 to 8 from generalized linear mixed model repeated measures method with treatment, sex, week, treatment by week, and baseline as fixed effects.|Baseline, Week 1 through Week 8|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.|||percentage of participants|||Number
2581070|NCT02397473|Secondary|Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)|PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, baseline cluster headache attack category, month, and treatment by month as fixed effects.|Week 8|All randomized participants who received at least one dose of study drug and had PGI-I measurement at week 8.|||percentage of participants|||Number
2581072|NCT02397473|Secondary|Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks|Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Overall mean change from baseline is derived from the average of weeks 1 to 8 from MMRM analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, pooled investigative site, week, baseline, and treatment by week as fixed effects.|Baseline, Week 1 through Week 8|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.|||Cluster Headache Attacks per Week||Standard Error|Least Squares Mean
2581073|NCT02397473|Secondary|Percentage of Participants With 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks|Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Percentage of participants with 50% or greater reduction from baseline at week 3 was analyzed using Koch's nonparametric randomization-based analysis of covariance method. This method adjusted for pooled investigative site by including it as a stratification variable. It also adjusted for sex and baseline value.|Baseline, Week 3|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.|||percentage of participants|||Number
2581074|NCT02397473|Primary|Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks|Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Overall mean change from baseline is derived from the average of weeks 1 to 3 from mixed model repeated measures (MMRM) analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, pooled investigative site, week, baseline, and treatment by week as fixed effects.|Baseline, Week 1 through Week 3|All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.|||Cluster Headache Attacks per Week||Standard Error|Least Squares Mean
2581075|NCT02397265|Primary|Percentage of Time in Target Range Over 24 Hour|The primary outcome from the studies will be time spent with a glucose concentration in the target range (3.9-10.0mmol/l).|24 hours||||percentage of time||Inter-Quartile Range|Median
2581076|NCT02397122|Secondary|Tissue Thickness|under local anesthesia, measured from 1.5 mm below the margin of the gingiva with a spreader and its stopper silicon disc. Then, distance of the marked point was measured by using a standardized caliper to the closest 0.1 mm by periodontal probe|Baseline, 6 weeks and 6 months|Data pertaining to 20 patients from each group were analysed after completing 6 months period|||mm||Inter-Quartile Range|Median
2581077|NCT02397122|Secondary|Keratinized Tissue Width|measured from margin of the gingiva to mucogingival junction by periodontal probe|Baseline, 6 weeks and 6 months|Data pertaining to 20 patients from each group were analysed after completing 6 months period|||mm||Inter-Quartile Range|Median
2581078|NCT02397122|Secondary|Attachment Level|measured from cementoenamel junction to gingival sulcus base by periodontal probe|Baseline, 6 weeks and 6 months|Data pertaining to 20 patients from each group were analysed after completing 6 months period|||mm||Inter-Quartile Range|Median
2581079|NCT02397122|Secondary|Probing Depth|measured from margin of the gingiva to gingival sulcus base by periodontal probe|Baseline, 6 weeks and 6 months|Data pertaining to 20 patients from each group were analysed after completing 6 months period|||mm||Inter-Quartile Range|Median
2581080|NCT02397122|Secondary|Horizontal Recession|measured horizontally between two borders of the recession at the line tangential to cementoenamel junction by periodontal probe|Baseline, 6 weeks and 6 months|Data pertaining to 20 patients from each group were analysed after completing 6 months period|||mm||Inter-Quartile Range|Median
2581081|NCT02397122|Primary|Vertical Recession|Measured from cementoenamel junction to margin of the gingiva by periodontal probe|Baseline, 6 weeks and 6 months||||mm||Standard Deviation|Mean
2581082|NCT02397096|Secondary|Percentage of Participants Discontinuing From Study Medication Due to an AE(s)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 24|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2581083|NCT02397096|Secondary|Percentage of Participants Experiencing ≥1 Serious Adverse Event (SAE)|A serious adverse event is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose, or is another important medical event. The percentage of participants with any SAE was assessed.|Up to 24 weeks|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2581084|NCT02397096|Secondary|Percentage of Participants Experiencing ≥1 Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to week 24|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2581085|NCT02397096|Secondary|Percentage of Participants With HIV-1 RNA >=50 Copies/mL|"The percentage of participants in each arm achieving HIV-1 RNA levels >=50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach."|Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2581086|NCT02397096|Secondary|Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL|To evaluate the immunological effect of an immediate switch to MK -1439A on Study Day 1 compared with continuation of a ritonavir boosted, PI-based regimen, as measured by the proportion of subjects maintaining HIV-1 RNA below the limit of quantification (BLoQ) by the Abbott RealTime HIV-1 Assay (<40 copies/mL) in both treatment groups.|Immediate Switch to MK-1439A arm: Week 24; Delayed Switch to MK-1439A arm: Week 24|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2581087|NCT02397096|Secondary|Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL|"The percentage of participants in each arm achieving HIV-1 RNA levels <40 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach and all missing data were considered treatment failures, regardless of the reason."|Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2581120|NCT02396511|Secondary|Frequency and Severity of Adverse Events|Adverse event frequency and severity according to CTCAE version 4.0.|Assessed weekly during and up to 28 days after completion of study protocol over a maximum period of 35 months.||||Events|||Number
2581175|NCT02396147|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.|||hours||Full Range|Median
2581088|NCT02397096|Secondary|Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts|The mean change from baseline in CD4 cell counts at Week 48 was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued due to lack of efficacy. Cell counts were measured and expressed as cells/mm^3, and percent change was then calculated. CD4 cell counts were quantified by a central laboratory using a commercially available assay.|Baseline and Week 24|All randomized participants who received at least 1 dose of study drug and had a measurement at baseline and had at least one post baseline time point assessed.|||cells/mm^3||Standard Deviation|Geometric Mean
2581089|NCT02397096|Secondary|Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts|The mean change from baseline in CD4 cell counts was assessed using the Observed Failure (OF) approach. With the OF approach, baseline values were carried forward for participants who discontinued due to lack of efficacy. Cell counts were measured and expressed as cells/mm^3, and percent change was then calculated. CD4 cell counts were quantified by a central laboratory using a commercially available assay.|Immediate Switch to MK-1439A arm: Baseline and Week 48; Delayed Switch to MK-1439A arm: Baseline and Week 24|All randomized participants who received at least 1 dose of study drug and had a measurement at baseline and had at least one post baseline time point assessed.|||cells/mm^3||Standard Deviation|Mean
2581090|NCT02397096|Secondary|Percentage of Participants Maintaining HIV-1 RNA <50 Copies/mL|"The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach and all missing data were considered treatment failures, regardless of the reason."|Week 24|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2581091|NCT02397096|Secondary|Mean Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (Non-HDL-C)|Serum non-HDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The Last Observation Carry Forward (LOCF) approach was applied for missing data or data collected after modifying lipid lowering therapy.|Baseline and Week 24|All randomized participants who received the ritonavir-boosted PI-based regimen at least 1 dose of study drug and had a measurement at baseline and had at least one post baseline time point assessed.|||mg/dL||Standard Deviation|Mean
2581092|NCT02397096|Secondary|Mean Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C)|To evaluate the effect on fasting LDL-C of an immediate switch to DOR/3TC/TDF on Study Day 1 compared with continuation of a ritonavir-boosted, PI-based regimen, as measured by mean change from baseline in each treatment group. The Last Observation Carry Forward (LOCF) approach was applied to missing data and data collected after a participant initiated lipid-modifying therapy.|Baseline and Week 24|All randomized participants in the ritonavir-boosted PI-based regimen who received at least 1 dose of study drug and had a measurement at baseline and had at least one post baseline time point assessed.|||mg/dL||Standard Deviation|Mean
2581093|NCT02397096|Primary|Percentage of Participants Maintaining Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL|"The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach and all missing data were considered treatment failures, regardless of the reason."|Immediate Switch to MK-1439A arm: Week 48; Delayed Switch to MK-1439A arm: Week 24|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2581094|NCT02396953|Secondary|PD Analysis: Mean Change From Baseline in Prolactin.|Blood samples were collected for the determination of prolactin in serum at Baseline (pre-dose) and at Weeks 2, 5, 13 and 25 (or EW). Summary data for serum concentration of prolactin were calculated and the mean change from Baseline at each time point is presented.|From Baseline (pre-dose) up to Week 25.|The safety population was all subjects who received the single dose of lanreotide PRF and had at least one post baseline safety assessment. Only subjects with data available for analysis are presented.|||mU/L||Standard Deviation|Mean
2581095|NCT02396953|Secondary|PD Analysis: Mean Change From Baseline in Thyroid Stimulating Hormone (TSH).|Blood samples were collected for the determination of TSH in serum at Baseline (pre-dose) and at Weeks 2, 5, 13 and 25 (or EW). Summary data for serum concentrations of TSH were calculated and the mean change from Baseline at each time point is presented.|From Baseline (pre-dose) up to Week 25.|The safety population was all subjects who received the single dose of lanreotide PRF and had at least one post baseline safety assessment. Only subjects with data available for analysis are presented.|||mIU/L||Standard Deviation|Mean
2581096|NCT02396953|Secondary|PD Analysis: Mean Change From Baseline in Free Triiodothyroxine (FT3) and Free Thyroxine (FT4).|Blood samples were collected for the determination of FT3 and FT4 in serum at Baseline (pre-dose) and at Weeks 2, 5, 13 and 25 (or EW). Summary data for serum concentrations of FT3 and FT4 were calculated and the mean change from Baseline at each time point is presented.|From Baseline (pre-dose) up to Week 25.|The safety population was all subjects who received the single dose of lanreotide PRF and had at least one post baseline safety assessment. Only subjects with data available for analysis are presented.|||picomole/litre (L)||Standard Deviation|Mean
2581097|NCT02396953|Secondary|PD Analysis: Mean Change From Baseline in Growth Hormone (GH).|GH cycle assessments were performed by taking 5 samples in the morning (with a sample taken every 30 minutes for 2 hours) at Baseline (pre-dose), Week 5 and Week 13. Summary data for the mean of the 5 samplings of the GH cycle were generated and the mean change from Baseline at each time point is presented.|From Baseline (pre-dose) up to Week 13.|The safety population was all subjects who received the single dose of lanreotide PRF and had at least one post baseline safety assessment. Only subjects with data available for analysis are presented.|||ng/mL||Standard Deviation|Mean
2581121|NCT02396511|Primary|Objective Response Rate of Two Patients With Metastatic and Refractory Choriocarcinoma by RECIST 1.1 Including Measurement of Serum β- hCG|"To determine the Objective Response Rate of two patients with metastatic and refractory choriocarcinoma by RECIST 1.1 including measurement of serum β- hCG. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) categorizes response as:~Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR) - >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"|Assessed every 8 weeks for up to 35 Months||||Participants|||Count of Participants
2581098|NCT02396953|Secondary|PD Analysis: Mean Change From Baseline in Insulin-like Growth Factor 1 (IGF-1).|Blood samples were collected for the determination of IGF-1 in serum at Baseline (pre-dose), 6 hours post-dose and at Weeks 5, 9 and 13. Samples were also collected during follow-up at Weeks 17, 21 and 25 (or EW). Serum concentrations of IGF-1 were calculated using the Immulite 2000 Platform for all subjects in the safety population. The production of the reagent kits was stopped by the vendor during the study. The old reagent kits were used for Cohorts 1 and 2 until their expiry date and then the kits were switched to a new reagent and used for remaining subjects in Cohorts 2 and 3. Summary data for serum concentrations of IGF-1 were obtained using both methods (old and new reagent) and the mean change from Baseline at each time point is presented.|From Baseline (pre-dose) up to Week 25.|The safety population was all subjects who received the single dose of lanreotide PRF and had at least one post baseline safety assessment. Only subjects with data available for analysis are presented.|||ng/mL||Standard Deviation|Mean
2581099|NCT02396953|Secondary|PK Analysis of Glycofurol Excipients: AUC0-∞ and Area Under the Serum Concentration Time Curve From Time 0 to Last Quantifiable Timepoint (AUC0-t).|"Blood samples for determination of the excipients (N1-glycofurol and N2-glycofurol) serum concentrations were collected at Baseline (pre-dose), at 1, 2, 4, 6, 8, 12 and 24 hours post-dose and on Days 3 and 5.~Mean serum N1-glycofurol and N2-glycofurol AUC0-∞ and AUC0-t values were determined using non-compartmental analysis. Only AUC0-∞ values fulfilling the accuracy determination rules were analysed."|From Baseline (pre-dose) up to Day 5.|The PK valid population consisted of subjects who received at least 1 dose and had no major protocol deviations affecting the PK variables, and who had a sufficient number of serum lanreotide concentrations to estimate the main PK parameters.|||ng*h/mL||Standard Deviation|Mean
2581100|NCT02396953|Secondary|PK Analysis of Glycofurol Excipients: Tmax.|"Blood samples for determination of the excipients (N1-glycofurol and N2-glycofurol) serum concentrations were collected at Baseline (pre-dose), at 1, 2, 4, 6, 8, 12 and 24 hours post-dose and on Days 3 and 5.~Median serum N1-glycofurol and N2-glycofurol Tmax values were determined using non-compartmental analysis."|From Baseline (pre-dose) up to Day 5.|The PK valid population consisted of subjects who received at least 1 dose and had no major protocol deviations affecting the PK variables, and who had a sufficient number of serum lanreotide concentrations to estimate the main PK parameters. Only subjects with data available for analysis are presented.|||hours||Full Range|Median
2581101|NCT02396953|Secondary|PK Analysis of Glycofurol Excipients: Cmax.|Blood samples for determination of the excipients (N1-glycofurol and N2-glycofurol) serum concentrations were collected at Baseline (pre-dose), at 1, 2, 4, 6, 8, 12 and 24 hours post-dose and on Days 3 and 5. Mean serum N1-glycofurol and N2-glycofurol Cmax values were determined using non-compartmental analysis.|From Baseline (pre-dose) up to Day 5.|The PK valid population consisted of subjects who received at least 1 dose and had no major protocol deviations affecting the PK variables, and who had a sufficient number of serum lanreotide concentrations to estimate the main PK parameters. Only subjects with data available for analysis are presented.|||ng/mL||Standard Deviation|Mean
2581102|NCT02396953|Secondary|Overall Summary of Number of Subjects With AEs.|AEs reported by the investigators using the National Cancer Institute-Common Toxicity Criteria (NCI CTCAE) classification (Version 4.03) and incidence of all reported treatment emergent AEs (TEAEs) and serious AEs (SAEs) are presented by dose cohort. AEs were assigned to a NCI CTCAE Grade from 1 through 5 as follows: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening or requiring hospitalisation; Grade 4: Life-threatening consequences; Grade 5: Death related to AE. TEAEs were defined as any AE that occurs during the active phase of the study (between the start of the 3 month treatment period and 3 months after the end of study treatment). The worst intensity of TEAES at each grade are reported for all and for related TEAES. In the event of multiple occurrences of the same AEs being reported by the same subject, the maximum intensity and the most serious causality were reported.|From Day -42 up to Week 25.|The safety population was all subjects who received the single dose of lanreotide PRF and had at least one post baseline safety assessment.|||participants|||Number
2581103|NCT02396953|Primary|PK Analysis of Lanreotide: Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC0-∞).|"Blood samples for determination of lanreotide serum concentrations were collected at Baseline (pre-dose), at 1, 2, 4, 6, 8,12 and 24 hours post-dose, on Days 3 and 5 and at Weeks 2, 3, 5, 9 and 13 after lanreotide PRF administration. Samples were also collected during follow-up at Weeks 17, 21 and 25 (or EW).~Mean serum lanreotide AUC0-∞ values were determined using non-compartmental analysis. Only values fulfilling the accuracy determination rules for AUC0-∞ were analysed."|From Baseline (pre-dose) up to Week 25.|The PK valid population consisted of subjects who received at least 1 dose and had no major protocol deviations affecting the PK variables, and who had a sufficient number of serum lanreotide concentrations to estimate the main PK parameters. Only subjects with data available for analysis and who were not pre-treated with lanreotide are presented.|||ng*day/mL||Standard Deviation|Mean
2581104|NCT02396953|Primary|PK Analysis of Lanreotide: Area Under the Serum Concentration-time Curve From Time 0 to 85 Days (AUC0-85).|"Blood samples for determination of lanreotide serum concentrations were collected at Baseline (pre-dose), at 1, 2, 4, 6, 8,12 and 24 hours post-dose, on Days 3 and 5 and at Weeks 2, 3, 5, 9 and 13 after lanreotide PRF administration. Sample were also collected during follow-up at Weeks 17, 21 and 25 (or EW).~Mean serum lanreotide AUC0-85 values were determined using non-compartmental analysis."|From Baseline (pre-dose) up to Day 85|The PK valid population consisted of subjects who received at least 1 dose and had no major protocol deviations affecting the PK variables, and who had a sufficient number of serum lanreotide concentrations to estimate the main PK parameters. Only subjects with data available for analysis and who were not pre-treated with lanreotide are presented.|||ng*day/mL||Standard Deviation|Mean
2581105|NCT02396953|Primary|PK Analysis of Lanreotide: Apparent Terminal Elimination Half-life (t1/2).|"Blood samples for determination of lanreotide serum concentrations were collected at Baseline (pre-dose), at 1, 2, 4, 6, 8,12 and 24 hours post-dose, on Days 3 and 5 and at Weeks 2, 3, 5, 9 and 13 after lanreotide PRF administration. Samples were also collected during follow-up at Weeks 17, 21 and 25 (or EW).~Mean serum lanreotide t1/2 values were determined using non-compartmental analysis. Only values fulfilling the determination rules for t1/2 were analysed."|From Baseline (pre-dose) up to Week 25.|The PK valid population consisted of subjects who received at least 1 dose and had no major protocol deviations affecting the PK variables, and who had a sufficient number of serum lanreotide concentrations to estimate the main PK parameters. Only subjects with data available for analysis and who were not pre-treated with lanreotide are presented.|||days||Standard Deviation|Mean
2581106|NCT02396953|Primary|PK Analysis of Lanreotide: Time to Reach Maximum Serum Concentration (Tmax).|"Blood samples for determination of lanreotide serum concentrations were collected at Baseline (pre-dose), at 1, 2, 4, 6, 8,12 and 24 hours post-dose, on Days 3 and 5 and at Weeks 2, 3, 5, 9 and 13 after lanreotide PRF administration. Samples were also collected during follow-up at Weeks 17, 21 and 25 (or EW).~Median serum lanreotide Tmax values were determined using non-compartmental analysis."|From Baseline (pre-dose) up to Week 25.|The PK valid population consisted of subjects who received at least 1 dose and had no major protocol deviations affecting the PK variables, and who had a sufficient number of serum lanreotide concentrations to estimate the main PK parameters. Only subjects with data available for analysis and who were not pre-treated with lanreotide are presented.|||days||Full Range|Median
2581107|NCT02396953|Primary|PK Analysis of Lanreotide: Maximum Observed Serum Concentration (Cmax).|"Blood samples for determination of lanreotide serum concentrations were collected at Baseline (pre-dose), at 1, 2, 4, 6, 8,12 and 24 hours post-dose, on Days 3 and 5 and at Weeks 2, 3, 5, 9 and 13 after lanreotide PRF administration. Samples were also collected during follow-up at Weeks 17, 21 and 25 (or EW).~Mean serum lanreotide Cmax values were determined using non-compartmental analysis."|From Baseline (pre-dose) up to Week 25.|The PK valid population consisted of subjects who received at least 1 dose and had no major protocol deviations affecting the PK variables, and who had a sufficient number of serum lanreotide concentrations to estimate the main PK parameters. Only subjects with data available for analysis and who were not pre-treated with lanreotide are presented.|||nanograms/millilitre (ng/mL)||Standard Deviation|Mean
2581108|NCT02396953|Primary|Determination of the Maximum Tolerated Dose (MTD) by Number of Subjects With DLTs.|The MTD was defined based on the DLTs observed in each cohort. A DLT was defined as an adverse event (AE) (excluding anorexia and fatigue) or an abnormal laboratory value occurring within the first week (up to Week 2) following lanreotide PRF administration and during the entire study duration, assessed as unrelated to acromegaly, intercurrent illness or concomitant medications and which met any of the pre-established toxicity criteria. If no DLTs were reported then no MTD could be defined.|From Day 1 up to Week 25.|The safety population was all subjects who received the single dose of lanreotide PRF and had at least one post baseline safety assessment.|||participants|||Number
2581109|NCT02396745|Secondary|Additional Interventions (Number of Subsequent Follow up Treatment Interventions)|To record the number of subsequent follow up treatment interventions (aside from study-related follow up time points) required post-procedure through 12 months.|12 months|Study terminated early. Subject participant experienced SAE and was followed for safety, no data outcomes analyzed||||||
2581110|NCT02396745|Secondary|Stent Integrity (e.g. Stent Fracture)|To record incidences of poor stent integrity during removal (e.g. stent fracture).|2 weeks|Study terminated early. Subject participant experienced SAE and was followed for safety, no data outcomes analyzed||||||
2581111|NCT02396745|Secondary|Stent Migration|To record the incidence of stent migration at 2 weeks post procedure. Stent migration will be determined endoscopically, and defined as any movement from initial deployment location greater than 1cm.|2 weeks|Study terminated early. Subject participant experienced SAE and was followed for safety, no data outcomes analyzed||||||
2581112|NCT02396745|Primary|Safety: Long-term (Study Related Adverse Events)|To demonstrate the long-term safety of TECR with ECM placement for treatment of BE with HGD by evaluating all study related adverse events occurring more than 2 weeks post procedure through 12 months post procedure.|Two weeks through 12 months post procedure||||Participants|||Count of Participants
2581113|NCT02396745|Primary|Safety: Acute (Serious System and Procedure Related Adverse Events)|To demonstrate the acute safety of TECR with ECM placement for treatment of BE with HGD by evaluating all serious system and procedure related adverse events occurring in the first 2 weeks post procedure.|Two weeks following procedure||||Participants|||Count of Participants
2581114|NCT02396745|Primary|Efficacy: Recurrent Disease|To evaluate incidence of recurrence of BE with HGD through 12 months following TECR with ECM placement. Incidence of disease recurrence will be confirmed endoscopically with pathology confirmed biopsies at 2 weeks, Month 1, Month 3, Month 6, Month 9, and Month 12 post procedure, and the proportion of subjects with and without disease recurrence at the trial endpoints will be compared to historical data.|12 months following procedure|Study terminated early. Subject participant experienced SAE and was followed for safety, no data outcomes analyzed||||||
2581115|NCT02396745|Primary|Efficacy: Stricture Formation|To evaluate incidence of stricture formation requiring dilation (≥30% luminal diameter reduction with dysphagia) following TECR with ECM placement. Evidence of stricture formation will be confirmed endoscopically at 2 weeks, and endoscopically and through barium swallow at Month 1, Month 3, Month 6, Month 9, and Month 12 post procedure, and the proportion of subjects with and without stricture formation at the trial endpoints will be compared to historical data.|12 months following procedure|Study terminated early. Subject participant experienced SAE and was followed for safety, no data outcomes analyzed||||||
2581116|NCT02396732|Secondary|Mortality|Mortality will be reported as the number of participants with reported death upon hospital discharge|Up to 2 months of hospitalization||||Participants|||Count of Participants
2581117|NCT02396732|Secondary|Change in Hypercoagulability|Assessed via the combination of routine laboratory values (Prothrombin Time and Partial Thromboplastin Time) evaluated through weekly thromboelastography (TEG)|Baseline, up to 2 months hospitalization|Data analysis was not completed for this outcome as samples were not collected as per protocol.||||||
2581118|NCT02396732|Primary|Incidence of Venous Thromboembolism|Incidence of VTE is defined as new cases reported of: 1. Deep Vein Thrombosis (DVT), symptomatic or asymptomatic as assessed via venous duplex ultrasonography, and 2. Pulmonary Embolism (PE), symptomatic or asymptomatic as assessed via chest computed tomography with angiography (CTA) or ventilation-perfusion (VQ) Scan|Up to 2 months of hospitalization||||incidents|||Number
2581119|NCT02396537|Primary|Discomfort With Intranasal Midazolam Administration|"subject self-reports pain with intranasal midazolam utilizing the Wong-Baker FACES Pain Scale. This scale is a well-established ordinal pain scale for pediatric patients. It is one score (no subscales), with a minimum score of 0 (signifying No Hurt) and a maximum score of 10 (Hurts Worst). Values between include 2 (Hurts Little Bit), 4 (Hurts Little More), 6 (Hurts Even More), and 8 (Hurts Whole Lot.). Children indicate one value/answer. Thus, a higher score indicates a worse outcome (more pain)."|immediately after administration of intranasal midazolam||||units on a scale||Inter-Quartile Range|Median
2581122|NCT02396511|Primary|Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma|Progression Free Survival of Two Patients With Metastatic and Refractory Choriocarcinoma determined according to RECIST 1.1 including measurement of serum β- hCG. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. A 5 mm absolute increase is also required to guard against over calling PD when the total sum is very small.|Assessed every 8 weeks for up to 35 Months||||Months||Full Range|Mean
2581123|NCT02396420|Other Pre-specified|Duration of [Urinary] Catheterization Post PAE|Parameter to be measured during PAE procedure, for informational purposes|Study treatment hospitalization (expected to be less than 1 day)|Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted.|||minutes||Full Range|Mean
2581124|NCT02396420|Other Pre-specified|Duration of Hospitalization Post PAE|Parameter to be measured during PAE procedure, for informational purposes|Study treatment hospitalization (expected to be less than 1 day)|Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted.|||minutes||Full Range|Mean
2581125|NCT02396420|Other Pre-specified|Number of Origins of Prostatic Blood Supply|Parameter to be measured during PAE procedure, for informational purposes|Study treatment hospitalization (expected to be less than 1 day)|Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE).|||number of vessels||Full Range|Mean
2581126|NCT02396420|Other Pre-specified|Volume of Embolic Delivered for PAE|Parameter to be measured during PAE procedure, for informational purposes|Study treatment hospitalization (expected to be less than 1 day)|Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE).|||milliliter||Full Range|Mean
2581127|NCT02396420|Other Pre-specified|Volume of Contrast Delivered for PAE|Parameter to be measured during PAE procedure, for informational purposes|Study treatment hospitalization (expected to be less than 1 day)|Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted.|||milliliter||Full Range|Mean
2581128|NCT02396420|Other Pre-specified|Type of Contrast Media Delivered for PAE|Parameter to be measured during PAE procedure, for informational purposes|Study treatment hospitalization (expected to be less than 1 day)|Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted.|||Participants|||Count of Participants
2581129|NCT02396420|Other Pre-specified|Total Fluoroscopy Time for PAE|Parameter to be measured during PAE procedure, for informational purposes.|Study treatment hospitalization (expected to be less than 1 day)|Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted.|||minutes||Full Range|Mean
2581130|NCT02396420|Other Pre-specified|Total PAE Procedure Time|Parameter measured during the PAE (index procedure) for informational purposes. Total PAE procedure time was defined as time of femoral artery puncture to the time of time sheath removed from femoral artery.|Study treatment hospitalization (expected to be less than 1 day)|Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted.|||minutes||Full Range|Mean
2581131|NCT02396420|Secondary|Overall Adverse Events|All adverse events will be assessed for severity, relationship to study treatment, subsequent treatment required, and outcome|12 Months|Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted.|||occurrence|||Number
2581132|NCT02396420|Secondary|Prostate Artery Embolization (PSA) Related Adverse Events|Number of occurrences of adverse events with some relationship to the study procedure or study device. An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject and does not necessarily have to have a causal relationship with the treatment. In order to capture the most potentially relevant safety information during the study, AEs were assessed at each visit. AEs occurring during the clinical trial and the protocol-defined 12-month follow-up period were reported.|12 Months|Analysis population includes all subjects, in the treatment arm, for whom prostate artery embolization (PAE) was attempted regardless of whether the subject received a unilateral PAE, bilateral PAE, or the attempted PAE was aborted.|||occurrence|occurrence||Count of Units
2581133|NCT02396420|Secondary|Change From Baseline in Serum Prostate Specific Antigen (PSA)|Serum prostate specific antigen (PSA) trends over time, may help to improve the specificity of PSA testing in men with BPH. A strong correlation has been demonstrated between prostate volume and serum PSA levels.|Baseline and12 Months|Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE) and completed the study thru Visit 5 (12 month follow-up).|||ng/mL|||Number
2581134|NCT02396420|Secondary|Change From Baseline in Erectile Function as Determined by the International Index of Erectile Function (IIEF)|The outcome measure was the International Index of Erectile Function (IIEF). The 15 question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment of erectile dysfunction and treatment. It is examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. The answer to each question is given a score between 0 and 5 for a total score of 0-75 (higher score = less dysfunction). Higher scores mean better outcome.|12 Months|Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE) and completed the study thru Visit 5 (12 month follow-up).|||units on scale|||Number
2581327|NCT02393950|Secondary|Peak Plasma Concentration (cMax) of ODM-106|cMax of ODM-106 after single dosing of either Capsule B or Capsule A|Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.||||ng/ml||Standard Deviation|Mean
2581136|NCT02396420|Secondary|Change From Baseline in Post Void Residual Volume (PVR) as Determined by Urodynamic Testing|Post void residual is a measurement of the amount of urine left in the bladder after voiding. It has traditionally been used to evaluate efficacy of treatment efforts. A positive response to treatment is associated with decreased PVR volumes.|12 Months|The one subject who completed the study thru Visit 5 refused to undergo urodynamic testing at Visit 5. As a result the PVR was not obtained. This was reported as a protocol deviation in the study.||||||
2581137|NCT02396420|Secondary|Change From Baseline in Peak Urine Flow Rate (Qmax) Determined by Urodynamic Testing|Peak urine flow rate (Qmax) is the greatest volumetric flow rate of urine during urination, measured as the quantity of urine excreted in a specified period of time (per second or per minute). Qmax has become a primary objective parameter of treatment outcomes for various surgical and medical therapies for BPH. Unlike other prominent parameters of treatment outcome, Qmax responds minimally to placebo, making it an objective tool when evaluating a patient's response to therapy.|12 Months|The one subject who completed the study thru Visit 5 refused to undergo urodynamic testing at Visit 5. As a result the Qmax was not obtained. This was reported as a protocol deviation in the study.||||||
2581138|NCT02396420|Secondary|Change From Baseline in Prostate Size, as Determined by MRI|Prostate size was determined by measuring the prostate with magnetic resonance imaging (MRI) and calculating length x width x height x pi/6.|Baseline and 12 months|Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE) and completed the study thru Visit 5 (12 month follow-up).|||grams|||Number
2581139|NCT02396420|Primary|Improvement of Symptoms Associated With Benign Prostatic Hyperplasia (BPH) as Assessed by the International Prostate Symptom Score (IPSS)|The outcome measure was the International Prostate Symptom Score (IPSS). The IPSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). A higher score means a worse outcome.|12 months|Analysis population includes all subjects in the treatment arm who received unilateral or bilateral prostate artery embolization (PAE) and completed the study thru Visit 5 (12 month follow-up).|||units on a scale|||Number
2581140|NCT02396381|Primary|Percent Change From Baseline of Carboxyhemoglobin (COHb)|"Carboxyhemoglobin (COHb) is assayed from whole blood.~Geometric Least Squares means are provided as descriptive statistics. Expressed as % of saturation of hemoglobin."|26 Weeks|Full Analysis Set – As Exposed (FAS-EX)|||percentage change from baseline||95% Confidence Interval|Geometric Mean
2581141|NCT02396381|Primary|Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL).|"Concentrations measured in urine and expressed as concentration adjusted for creatinine.~Geometric Least Squares means are provided as descriptive statistics."|26 Weeks|Full Analysis Set – As Exposed (FAS-EX)|||pg/mg creat||95% Confidence Interval|Geometric Mean
2581142|NCT02396381|Primary|Concentrations of 8-epi-prostaglandin F2α (8-epi-PGF2α).|"Concentrations measured in urine and expressed as concentration adjusted for creatinine.~Geometric Least Squares means are provided as descriptive statistics."|26 Weeks|Full Analysis Set – As Exposed (FAS-EX)|||pg/mg creat||95% Confidence Interval|Geometric Mean
2581143|NCT02396381|Primary|Concentrations of 11-dehydrothromboxane B2 (11-DTXB2).|"Concentrations measured in urine and expressed as concentration adjusted for creatinine.~Geometric Least Squares means are provided as descriptive statistics."|26 Weeks|Full Analysis Set – As Exposed (FAS-EX)|||pg/mg creat||95% Confidence Interval|Geometric Mean
2581144|NCT02396381|Primary|Concentrations of Soluble Intercellular Adhesion Molecule 1 (sICAM-1).|"Concentrations measured in serum.~Geometric Least Squares means are provided as descriptive statistics."|26 Weeks|Full Analysis Set – As Exposed (FAS-EX)|||ng/mL||95% Confidence Interval|Geometric Mean
2581145|NCT02396381|Primary|Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1).|"FEV1 post-bronchodilator and expressed as percentage predicted (FEV1 %pred).~Geometric Least Squares means are provided as descriptive statistics."|26 Weeks|Full Analysis Set – As Exposed (FAS-EX)|||Percent of predicted FEV1||95% Confidence Interval|Geometric Mean
2581146|NCT02396381|Primary|Levels of White Blood Cells (WBC).|"Concentrations measured in blood.~Geometric Least Squares means are provided as descriptive statistics."|26 Weeks|Full Analysis Set – As Exposed (FAS-EX)|||GI/L||95% Confidence Interval|Geometric Mean
2581147|NCT02396381|Primary|Levels of High Density Lipoprotein C (HDL-C).|"Concentrations measured in serum.~Geometric Least Squares means are provided as descriptive statistics."|26 Weeks|Full Analysis Set – As Exposed (FAS-EX)|||mg/dL||95% Confidence Interval|Geometric Mean
2581148|NCT02396316|Secondary|Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1|NVI were assessed in the study eye using the NVI grading systems (grade 0 to grade 4). A subject who shows the improvement by at least one grade is considered to be improved. Percentage of subjects who had improved NVI grade was reported.|From baseline to pre-dose at Week 1|FAS|||Percentage of participants|||Number
2581149|NCT02396316|Primary|Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1|It compared the change in IOP from baseline to pre-dose at Week 1 between the aflibercept group vs the sham group.|From baseline to pre-dose at Week 1|FAS: The Full Analysis Set (FAS) included all randomized subjects who have received any study drug (including sham injection) and had had a baseline and at least one post-baseline IOP measurement on a posterior date. The FAS was analyzed as randomized.|||mmHg||Standard Deviation|Mean
2581150|NCT02396251|Secondary|Percentage of Responders in Midface Fullness Using Photo Scale|Evaluate midface fullness as determined by percentage of responders at 4 weeks and 6, 9, 12 and, if applicable, 15 months after last treatment as well as 4 weeks and 3 months after re-treatment, derived from the Blinded Evaluator's live assessment of photo scale. A responder was defined as a subject with ≥1 grade improvement from baseline in both cheeks.|15 months|"Number of participants with available data varied during the study. The secondary objective applied to the group treated with the investigational HA product in both cheeks.~Only exploratory objective applied to the split-face group."|||percentage of participants||95% Confidence Interval|Number
2581450|NCT02392351|Secondary|Number of Hospitalizations Due to Severe Hypotension/Syncope|Number of hospitalizations due to severe hypotension/syncope through 6 months.|Through 6 months||||Participants|||Count of Participants
2581151|NCT02396251|Primary|Percentage of Responders in Midface Fullness Using Photo Scale|Evaluation of midface fullness, determined by the percentage of responders at 3 months after last treatment, in both cheeks, derived from the Blinded Evaluator's live assessment of a validated photo scale. A responder was defined as a subject with ≥1 grade improvement from baseline in both cheeks.|3 months|"The primary objective applied to the group treated with the investigational HA product in both cheeks.~Only exploratory objective applied to the split-face group."|||percentage of participants||95% Confidence Interval|Number
2581152|NCT02396212|Secondary|Pharmacodynamics (PD) Assessment: Total IL-1 Beta|To evaluate serum total IL-1 Beta concentration by visit.|Baseline, Weeks 4, 24, 48, 72, 96, EOS (up to Week 164)|The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab.|||pg/mL||Standard Deviation|Mean
2581153|NCT02396212|Secondary|Serum Concentration of Canakinumab|To evaluate serum concentration (mean, standard deviation) of canakinumab.|Baseline, Weeks 4, 24, 48, 72, 96, EOS (up to Week 164)|The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab.|||μg/mL||Standard Deviation|Mean
2581154|NCT02396212|Secondary|Absolute Change From Baseline of Corticosteroids Dose Reduction With Canakinumab Treatment Over Time|To evaluate the change from baseline of corticosteroids dose reduction with canakinumab treatment over time|Baseline, Weeks 28, 48, 96, 144, EOS (up to Week 164)|The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab.|||mg/kg/day||Standard Deviation|Mean
2581155|NCT02396212|Secondary|Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully Over Time|To evaluate the percentage of participants with canakinumab treatment who were able to taper corticosteroids successfully over time|Weeks 28, 48, 96, 144, EOS (up to Week 164)|The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab.|||percentage of perticipants|||Number
2581156|NCT02396212|Secondary|Percentage of Participants Who Achieved Inactive Disease (With and Without Duration of Morning Stiffness) With Canakinumab Treatment Over Time|Inactive disease was defined as meeting all of the following: No joints with active arthritis; No fever (body temperature ≤ 38°C); No rheumatoid rash, serositis, splenomegaly, hepatomegaly or generalized lymphadenopathy attributable to JIA; Normal CRP; Physician's global assessment of disease activity score ≤ 10 mm|Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164)|The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab.|||Percentage of participants|||Number
2581157|NCT02396212|Secondary|Percentage of Participants Who Had Flares With Canakinumab Treatment Over Time|Flare was defined by at least 1 of the following: Reappearance of SJIA-related (e.g., not due to infection) fever (> 38°C) lasting for at least 2 consecutive days &/OR Flare according to the JIA pediatric criteria for flare (all criteria must be met): ≥ 30% worsening in at least 3 of the 6 response variables and ≥ 30% improvement in at not more than 1 of the 6 response variables if the physician's or parent's global assessment is 1of 3 response variables used to define flare, worsening of ≥ 20 mm must be present, if the number of active joints or joints with limitation of motion is one of 3 response variables used to define flare, worsening in ≥ 2 joints must be present if CRP is used to define flare, CRP must be > 30 mg/L|> Day3, to <= Week 124|The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab.|||Percentage of participants|||Number
2581158|NCT02396212|Secondary|Percentage Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Standardized C-Reactive Protein (CRP)|ACR component, Standardized CRP is the sixth response variable in the ACR ped criteria. CRP values were standardized to a normal range of 0 to 10 mg/L.|Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164)|The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab.|||Percentage change||Standard Deviation|Mean
2581159|NCT02396212|Secondary|Number of Participants Having Fever in the Adapted ACR Pediatric Criteria of Canakinumab Over Time|ACR component, Number of participants having fever is the seventh response variable in the ACR ped criteria.|Baseline, Day 3, Weeks 2, 8, 28, 48, 56, 96, 124, 144, EOS (up to Week 164)|The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab.|||participants|||Number
2581160|NCT02396212|Secondary|Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Number of Joints With Limitation of Motion|ACR component, Number of joints with limitation of motion is the fifth response variable in the ACR ped criteria.|Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164)|The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab.|||joints||Standard Deviation|Mean
2581161|NCT02396212|Secondary|Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Number of Joints With Active Arthritis|ACR component, Number of joints with active arthritis was assessed as the forth response variables of ACR Pediatric Criteria.|Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164)|The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab.|||joints||Standard Deviation|Mean
2581162|NCT02396212|Secondary|Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: CHAQ: Functional Ability Score|"Disability Score as part of CHAQ per functional ability score (range from 0 to 3) is one of the variable in the ACR ped criteria. The CHAQ was used to assess physical ability & functional status of patients as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activity categories of daily living: dressing & grooming, arising, eating, walking, reaching, personal hygiene, gripping & other activities. Subjects choose from 4 responses, ranging from 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) & 3 (unable to do). Standard Disability Index (SDI) was computed by summing up the computed scores for each activity category and dividing by the number of categories answered. The lower the response the more positive the results & the higher the response, the less positive the results. Change from baseline was calculated by subtracting baseline value from post baseline value."|Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164)|The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab.|||units on a scale||Standard Deviation|Mean
2581176|NCT02396147|Secondary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study.|From Day 1 to Day 26|Safety population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2581163|NCT02396212|Secondary|Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: CHAQ: Parent's or Patient's Global Assessment of Patient's Overall Well-being as Part of CHAQ|ACR component, Parent's or Patient's (if appropriate in age)Global Assessment of patient's overall well-being as part of CHAQ on a 0 - 100 mm VAS by visit is the second response variable in the ACR pediatric criteria. The VAS scale ranges from 0-100 mm, from very well (0 mm) to very poor (100 mm). Lower scale indicates improvement of patient's overall well-being. Absolute change is calculated by subtracting baseline value from post baseline value.|Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS up to Week 164|The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab.|||units on a scale||Standard Deviation|Mean
2581164|NCT02396212|Secondary|Absolute Change From Baseline in the Adapted ACR Pediatric Criteria of Canakinumab Over Time: ACR Component: Physician's Global Assessment of Disease Activity|ACR component, Physician's Global Assessment of disease activity on a 0 - 100 mm VAS by visit is the first response ACR variable in the ACR pediatric criteria. The VAS scale ranges from no disease activity (0 mm) to very severe disease activity (100 mm). Lower scale indicates decreased disease activity. Change from baseline was calculated by subtracting baseline value from post baseline value.|Baseline, Weeks 4, 8, 28, 48, 96, 144, EOS (up to Week 164)|The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab.|||units on a scale||Standard Deviation|Mean
2581165|NCT02396212|Secondary|Percentage of Participants Who Met the Adapted ACR Pediatric 30/50/70/90/100 Criteria of Canakinumab Over Time|Adapted ACR Pediatric 30/50/70/90/100 criteria was assessed based on the following 7 variables: 1. Physician's Global Assessment of disease activity on a 0-100 mm VAS; 2. Parent's or Patient's (if appropriate in age) Global Assessment of Patient's overall wellbeing based upon the 0-100 mm VAS in the CHAQ; 3. Functional ability: CHAQ; 4. Number of joints with active arthritis; 5. Number of joints with limitation of motion; 6. Laboratory measure of inflammation: CRP (mg/L); 7. Absence of intermittent fever due to SJIA during the preceding week. Response was defined as more than or equal to (≥) 30%/50%/70%/90% or 100% improvement in at least 3 of 6 response variables and no intermittent fever in the preceding week (variable 7) with no more than one variable 1-6 worsening by more than 30%.|Weeks 4, 8, 28, 48, 96, 144, end of study (EOS) (up to Week 164)|The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab.|||Percentage of Participants|||Number
2581166|NCT02396212|Primary|Percentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully|To evaluate the percentage of participants with canakinumab treatment who were able to taper corticosteroids successfully at Week 28|Week 28|The FAS consisted of all 19 patients who were enrolled and received at least one dose of canakinumab.|||Percentage of Participants|||Number
2581167|NCT02396212|Primary|Percentage of Participants Who Achieved a Minimum Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria|Minimum Adapted ACR Pediatric 30 criteria is defined as improvement from baseline at least 30% in at least 3 of response variables 1 to 6 in Adapted ACR Pediatric response variables and no intermittent fever (i.e. axillary, oral, or rectal body temperature ≤ 38°C) in the preceding week (variable 7), with no more than one variable 1-6 worsening by more than 30%. Adapted ACR Pediatric response variables consists of following 7 variables: 1. Physician's Global Assessment of disease activity on a 0-100 mm VAS; 2. Parent's or Patient's (if appropriate in age) Global Assessment of Patient's overall wellbeing based upon the 0-100 mm VAS in the Child Health Assessment Questionnaire (CHAQ); 3. Functional ability: CHAQ; 4. Number of joints with active arthritis; 5. Number of joints with limitation of motion; 6. Laboratory measure of inflammation: CRP (mg/L); 7. Absence of intermittent fever due to SJIA during the preceding week.|Week 8|The Full Analysis Set (FAS) consisted of all 19 patients who were enrolled and received at least one dose of canakinumab.|||Percentage of Participants|||Number
2581168|NCT02396160|Secondary|Stress Incontinence Frequency|Stress incontinence as defined by number of episodes of incontinence per day related to stress, recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being stress incontinence frequency ≥1 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.|||Number of stress incontinence episodes||95% Confidence Interval|Mean
2581169|NCT02396160|Primary|Nocturia Frequency|Night time urinary frequency as defined as the number of voluntary nocturnal micturition's per day recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being nocturnal frequency ≥2 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.|||number of nocturnal micturitions||95% Confidence Interval|Mean
2581170|NCT02396160|Secondary|Urge Incontinence Frequency|Urge incontinence as defined by number of incontinence episodes per day resulting from urinary urgency, recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being urge incontinent frequency ≥1 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.|||number of urge incontinence episodes||95% Confidence Interval|Mean
2581171|NCT02396160|Secondary|Urinary Urgency Frequency|Urinary urgency as defined by number of urgency episodes per day recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being urgency urination frequency ≥1 per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.|||number of urgency episodes||95% Confidence Interval|Mean
2581172|NCT02396160|Primary|Day Urinary Frequency|Day urinary frequency as defined as the number of voluntary diurnal micturitions per day, recorded in a validated urinary diary|8 weeks|Analysis includes participants who met the criteria for this outcome being day urination frequency ≥10 daytime micturitions per day at baseline. Please note that not all participants in this study met the criteria for all outcomes, hence numbers in each section may seem incongruent with total study participants.|||number of diurnal micturitions per day||95% Confidence Interval|Mean
2581173|NCT02396147|Secondary|Oral Clearance (CL/F) for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.|||liters (L)/hr||Geometric Coefficient of Variation|Geometric Mean
2581177|NCT02396147|Secondary|Percentage of Participants With Electrocardiogram (ECG) Parameters Abnormal and Clinically Significant|A 12-lead ECG was administered. The investigator interpreted the ECG using one of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant.|Days 1, 11, 21 and 26|Safety population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2581178|NCT02396147|Secondary|Number of Participants With Shifts From Normal at Baseline in Safety Laboratory Values in More Than 1 Participant|Participants with shifts from normal at Baseline in safety laboratory values (Clinical Chemistry, Hematology and Urinalysis) collected throughout study. Low=below normal reference range, Normal=within reference range, High=above normal reference range and Abnormal=outside of normal reference range.|Baseline and Days 4, 10, 14, 20, 24 and 26|Safety population included all participants who received at least 1 dose of study drug.|||participants|||Number
2581179|NCT02396147|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|From Day 1 to 30 days after the last dose of study drug (Up to 51 days total)|Safety population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2581180|NCT02396147|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|PK-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2581181|NCT02396147|Primary|AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|PK-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2581182|NCT02396147|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-385||Days 1, 11, and 21 predose and at multiple time points (up to 120 hours) post-dose|Pharmacokinetic (PK)-Evaluable population included participants who had sufficient dosing and PK data for analysis, and who did not receive any excluded medications.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2581183|NCT02395822|Secondary|Number of Subjects Achieving Complete Response, Defined as in Vivo Donor Derived NK Cell Expansion of > 100 Donor Derived NK Cells.||Day 42 post NK cell infusion||||Participants|||Count of Participants
2581184|NCT02395822|Secondary|Treatment Related Mortality||6 months post-therapy|1 patient left the study|||Participants|||Count of Participants
2581185|NCT02395822|Secondary|Proportion of Patients Experiencing Grade, 3, 4, and 5 Toxicities (Assessed by CTCAE v. 4)||Days 1-5 and Days 8-12, 24 hours after the last IL-15 dose, Day +28, Day +42||||Participants|||Count of Participants
2581186|NCT02395822|Secondary|In Vivo Expansion (>100) of NK Cells (Defined at CD56+/CD3- Lymphocytes)||Day 14 post NK cell infusion||||Participants|||Count of Participants
2581187|NCT02395822|Primary|< 5% Marrow Blast, no Circulating Peripheral Blasts and Neutrophil Count of > 1 x 10^9/L|Without platelet recovery|Day 42 post NK cell infusion||||Participants|||Count of Participants
2581188|NCT02395692|Other Pre-specified|MPG, Topo II-alpha, and MGMT Levels in Tissue Samples|MPG, topo II-alpha, and MGMT levels will be correlated with response, PFS, and overall survival. Will be analyzed using standard descriptive statistical methods.|Baseline|Data was not collected to assess this outcome measure.||||||
2581189|NCT02395692|Secondary|Overall Survival|Will be analyzed using standard descriptive statistical methods.|Up to at least 2 years||||months||95% Confidence Interval|Median
2581190|NCT02395692|Secondary|Progression-free Survival at 6 Months|Will be analyzed using standard descriptive statistical methods.|6 months||||Participants|||Count of Participants
2581191|NCT02395692|Secondary|Progression-free Survival|Will be analyzed using standard descriptive statistical methods. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to at least 2 years||||months||Full Range|Median
2581192|NCT02395692|Secondary|Toxicity as Assessed by Number of Participants Who Experienced Adverse Events|Number of participants who experience adverse events graded 3 or higher as defined by National Cancer Institute CTCAE v4.0.|Up to 30 days following the last dose of study drug|Patients diagnosed with glioblastoma|||Participants|||Count of Participants
2581193|NCT02395692|Primary|Objective Response as Assessed by Response Assessment in Neuro-Oncology (RANO) Criteria (Arm 1 and Arm 2)|"To test the hypothesis that the combination treatment of temozolomide and methoxyamine will achieve 30% radiographic response rate (partial response + complete response) in patients with first recurrence of glioblastoma.~Per Response Assessment in Neuro-Oncology (RANO) Criteria: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Up to at least 2 years|This was a 2 stage design study. if there were less than 2 responders in first 19 subjects, study would terminate and Arm2 would not accrue any subjects.|||Participants|||Count of Participants
2581194|NCT02395666|Secondary|Time to Reach Peak Plasma Concentration (Tmax)|"Pharmacokinetic assay- tmax, hr~Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different days"|0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose on two different days|12 subjects from both Stratum 1 and 2 were analyzed together as one group as per statistical analysis plan.|||hours||90% Confidence Interval|Mean
2581443|NCT02392351|Secondary|Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure Through 6 Months|Change (mean reduction) in average 24-hour ambulatory diastolic blood pressure at 6 months compared to baseline.|6 Months|Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment.|||mmHg||Standard Deviation|Mean
2581196|NCT02395666|Secondary|Peak Plasma Concentration (Cmax)|"Pharmacokinetic assay Cmax/D~Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different days."|Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different days|12 subjects from both Stratum 1 and 2 were analyzed together as one group as per statistical analysis plan.|||ng/mL||90% Confidence Interval|Mean
2581197|NCT02395666|Secondary|Circulating Tumor Cell Analysis|circulating tumor cell analysis|5 years||2022-09-30|09/2022||||
2581198|NCT02395666|Secondary|Test the Association of Survival With ODC1 Genotype|"Tests (p-value) of the association of survival with ODC1 single nucleotide polymorphism rs2302616 genotype.~Blood: microRNA analysis as predictor of DFMO effect, ornithine decarboxylase (ODC) single nucleotide polymorphism (SNP) analysis in DNA isolated from nucleated cells"|2 years|Stratum 1 and 2 were analyzed together as one group as per statistical analysis plan.|||p-value|||Number
2581199|NCT02395666|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|To continue to determine the safety and tolerability of DFMO as a single agent and in pediatric and young adult patients with high risk neuroblastoma that is in remission.|2 years|Stratum 1 and 2 were analyzed together as one safety group as per statistical analysis plan.|||Participants|||Count of Participants
2581200|NCT02395666|Secondary|Percentage of Participants With Overall Survival (OS)|To evaluate the preventative activity of DFMO as a single agent in patients with neuroblastoma who are in remission based on: Overall Survival (OS)|2 Years||||percentage of subjects without an event||95% Confidence Interval|Mean
2581201|NCT02395666|Primary|Number of Participants With Event Free Survival (EFS) During Study.|To evaluate the preventative activity of DFMO as a single agent in patients that are in remission based on: Event free survival (EFS)|2 Years|One subject removed from Stratum 1 due to not fitting study criteria upon review|||percentage of subjects without an event||95% Confidence Interval|Mean
2581202|NCT02395653|Secondary|Number Of Participants To Experience Clinically Relevant Respiratory Depression (CRRD)|Respiratory function and occurrence of CRRD was defined as simultaneous occurrence of bradypnoea (respiratory rate <10 breaths per minute for participants 9-15 years of age and sustained for 1 minute, or <8 breaths per minute for participants 16-17 years of age), with excessive sedation (that is, the participant is not easily aroused).|From the time of application of the first system through 7 days following end of study drug administration.|The Evaluable Population consists of all participants who received fentanyl from the SSEC for at least 3 hours.|||participants|||Number
2581203|NCT02395653|Secondary|Change From Baseline To 1 Hour And 24 Hours In Skin Irritation Score After SSEC Removal|Skin irritation at the SSEC application site was to be assessed immediately prior to placement of the study system and at 1 and 24 hours after removal of each study system. The application site was to be scored using the following scale: 0=No evidence of irritation; 1=Minimal erythema, barely perceptible; 2=Definite erythema, readily visible, minimal edema, or minimal papular response; 3=Erythema and papules; 4=Definite edema; 5=Erythema, edema, and papules; 6=Vesicular eruption; 7=Strong reaction spreading beyond the application site.|Baseline, 1 hour and 24 hours after SSEC removal.|The Evaluable Population consists of all participants who received fentanyl from the SSEC for at least 3 hours.|||units on a scale||Standard Deviation|Mean
2581204|NCT02395653|Primary|Assessment Of Adherence Of The SSEC System To Skin|The adhesion of each SSEC was evaluated immediately prior to removal at each 24-hour time point, or at early withdrawal. Adhesion was recorded using the following classification: System adhered to at least 90% of the application area with no edges unattached; System adhered between 75% and 89%; System was <75% adhered and not taped; System was secured with tape. The number of SSEC systems for all time points in each category is presented. Because of the descriptive nature of this study, no formal statistical hypothesis testing was performed.|Immediately prior to removal at each 24-hour time point, or at early withdrawal, for up to 3 consecutive days (up to 72 hours)|The Evaluable Population consists of all participants who received fentanyl from the SSEC for at least 3 hours.|||SSEC systems|SSEC systems used by 61 participants||Number
2581205|NCT02395653|Primary|Assessment Of Participant's Ability To Use The SSEC|Investigator's assessment of participant's ability to use the SSEC system safely and effectively. The assessment consisted of a 4-level categorical evaluation (poor, fair, good, and excellent). Because of the descriptive nature of this study, no formal statistical hypothesis testing was performed.|Completed at the time of the participant's termination of study treatment (up to 72 hours after study drug administration)|The Evaluable Population consists of all participants who received fentanyl from the SSEC for at least 3 hours.|||participants|||Number
2581206|NCT02395536|Primary|Untoward Event Rate Associated With LINQ™ Insertions Performed|"Demonstrate that the untoward event rate associated with Reveal LINQ™ insertions performed in-office or in the traditional hospital setting (operating room, cardiac catheterization or EP laboratory) are comparable.~Untoward events are a composite of unsuccessful Reveal LINQ™ or complications related to the Reveal LINQ™ insertion procedure or system."|3 Months post insertion|Subjects exiting prematurely (prior to 3-month visit) without an untoward event were excluded from primary analysis. There were 7 excluded from the In office arm (2 deaths unrelated to the REVEAL LINQ and 5 premature exits) and 4 excluded from the traditional hospital setting arm (all 4 due to premature exit)|||Participants|||Count of Participants
2581207|NCT02395471|Secondary|Ongoing Safety Measures|To collect and analyze ongoing safety measures of Cytosponge use in the target population.|Immediately post procedure up to 7 days +/- 3 days||||Participants|||Count of Participants
2581208|NCT02395471|Secondary|Summary of Abrasion, Bleeding, and Perforation Observed Via Endoscopy|The fourth secondary objective was to assess the degree of mucosal abrasion following Cytosponge™ administration, using a standardized scale. The incidence is presented in the data below for abrasion, bleeding and perforation observed during Endoscopy.|Immediately post procedure up to 7 days +/- 3 days||||Participants|||Count of Participants
2581232|NCT02395172|Secondary|Overall Survival (OS) Time in Full Analysis Set Population|The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.|Time from date of randomization up to data cutoff (assessed up to 907 days)|Full analysis set (FAS) included all participants who were randomized to study treatment.|||months||95% Confidence Interval|Median
2581209|NCT02395471|Secondary|Cytosponge™ Operating Characteristics as a Function of Baseline Histology|The third secondary objective was to assess the operating characteristics of Cytosponge™ as a function of baseline histology. At the outset of this study, no data was available regarding the accuracy of TFF3 in samples collected by Cytosponge™ in subjects with BE and more advanced disease (low-grade dysplasia and high-grade dysplasia). These subjects are at greatest risk for progression to cancer. We planned to collect pilot data on operating characteristics of the assay by degree of baseline dysplasia. We hypothesized that TFF3 would perform with similar operating characteristics in this group compared to non-dysplastic BE.|Immediately post procedure up to 7 days +/- 3 days|Among study subjects with BE that exhibited HGD, there were no true negatives or false positives, therefore specificity of the assay was not calculated for this subgroup.|||Percentage|||Number
2581210|NCT02395471|Secondary|Cytosponge™ Operating Characteristics vs Worst Histology Ever|The second secondary objective was to assess the operating characteristics of Cytosponge™ against the worst ever histology documented in the subject.|Immediately post procedure up to 7 days +/- 3 days||||Percentage||95% Confidence Interval|Number
2581211|NCT02395471|Secondary|Operating Characteristics|The operating characteristics of this technique against a gold standard of upper endoscopy with biopsies for endoscopic surveillance in subjects with BE who demonstrate an adequate sample on Cytosponge assessment.|Immediately post procedure up to 7 days +/- 3 days||||Percentage||95% Confidence Interval|Number
2581212|NCT02395471|Primary|Number of Participants With Adequate Cytosponge™ Sample|To assess the adequacy of cytology samples obtained by Cytosponge in this population after 1 sampling, and after 2 samplings if first sample inadequate.|Immediately post procedure up to 7 days +/- 3 days||||Participants|||Count of Participants
2581213|NCT02395471|Primary|Procedure Preference and Acceptability Questionnaire and Visual Analog Scale|The first primary objective of the study was to assess the acceptability of a novel, minimally invasive esophageal mucosal sampling technique, the Cytosponge™, in subjects undergoing surveillance of BE who have had at least a C1 or M3 segment confirmed, and 2) in subjects with GERD undergoing screening for BE. This includes measures of acceptability as demonstrated on the Impact of Event Scale, a Visual Analog Scale for Pain, and the subject's willingness to undergo repeat Cytosponge™ administration if it were offered to him/her. The Visual Analog Scale is measured from 0-100 scale for pain, 0 representing no pain and 100 representing the highest level of pain.|Immediately post procedure up to 7 days +/- 3 days||||Units on a scale||Standard Deviation|Mean
2581214|NCT02395302|Primary|Number of Participants Who Agreed With Tolerance and Comfort Questionnaire Items After Using a Dual Action Pneumatic Compression Device|"A questionnaire that was completed after receiving four weeks of treatment from a dual action pneumatic compression device. Questions listed below:~The device was comfortable to wear during Sustained Compression Mode.~The device was comfortable to wear during Intermittent Compression Mode.~The noise from the device was not bothersome.~The device was easy to put on.~The device was easy to take off.~The device was easy to use.~The device was light-weight and portable.~The use of the device helped my wound heal faster.~I would use the device again on another wound in the future.~Since using the device, my quality of sleep has improved.~It was a burden to come to the wound care clinic for my dressing changes.~The use of the device did not restrict many of my normal activities.~The device was cumbersome and interfered with my mobility.~I was able to work while being treated with the device."|4 weeks|"The Tolerance and Comfort questionnaire was completed at study exit by 16 participants (13 of the 16 total subjects completed the study, 2 were withdrawn by their site's Investigator, and 1 voluntarily withdrew).~Six participants were not employed during the time of questionnaire completion. Question 14 was not applicable to these participants."|||Participants|||Count of Participants
2581215|NCT02395185|Secondary|Oxygen Saturation|Oxygen saturation will be recorded at minute intervals. A pre casting measure from the average of the first 3 minute measures prior to casting; a during casting measure from the average of the measures at 1 minute intervals during casting; and a post casting measure from the average of the 3 minute measures post casting.|Oxygen saturation will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting|Because this was a crossover design, multiple casts were assessed for each participant|||percentage of SpO2|casts|Standard Deviation|Mean
2581216|NCT02395185|Secondary|Heart Rate|Heart rate will be recorded at minute intervals. A pre casting measure from the average of the first 3 minute measures prior to casting; a during casting measure from the average of the measures at 1 minute intervals during casting; and a post casting measure from the average of the 3 minute measures post casting.|Heart rate will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting.|Because this was a crossover design, multiple casts were assessed for each participant|||bpm|casts|Standard Deviation|Mean
2581217|NCT02395185|Primary|NIPS (Neonatal Infant Pain Scale)|Each cast visit will be videotaped before, during, and after casting, and later reviewed for subjective evaluation of pain using NIPS (Neonatal Infant Pain Scale). The NIPS examines six behavioral groupings that contribute to a pain score ranging from 0 to 7: facial expression (relaxed muscles or grimace), cry (no cry, whimper, or vigorous cry), breathing patterns (relaxed, change in breathing), arms (relaxed/restrained, flexed/extended), legs (relaxed/restrained, flexed/extended), state of arousal (sleeping/awake, fussy). Scoring will take place by a trained study personnel blinded to the contents of the bottle. Scoring for all measures will be recorded at minute intervals. A pre casting score from the average of the first 3 minute scores prior to casting; a during casting score from the average of the scores at 1 minute intervals during casting; and a post casting score from the average of the 3 minute scores post casting. Scores are categorized as 0 no pain, to >4 severe pain.|Scoring will be recorded at minute intervals starting at 2 minutes prior to casting and ending at 3 minutes post casting.|Because this was a crossover design, multiple casts were assessed for each participant|||units on a scale|casts|Standard Deviation|Mean
2581218|NCT02395172|Secondary|Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab||Time from date of randomization up to data cutoff (assessed up to 907 days)|"Full analysis set (FAS) included all participants who were randomized to study treatment. Here, Overall Number of Participants Analyzed signified participants with at least on valid ADA result at any time point."|||Participants|||Count of Participants
2581468|NCT02392208|Secondary|AUC0-24 of Telavancin|Area under the telavancin concentration-time curve 0-24 hours from start of infusion|At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48||||mcg*h/mL||Standard Deviation|Mean
2581219|NCT02395172|Secondary|Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score|ECOG performance status measured to assess participant's performance status on a scale of 0 to 5, where 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory and capable of all selfcare but unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed/chair for more than 50 percent of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead. The participants with missing worst post baseline score were also reported. ECOG performance status was reported in terms of number of participants with Baseline value vs. worst post-baseline value (i.e. highest score) combination.|Time from date of randomization up to data cutoff (assessed up to 907 days)|Safety analysis set included all participants who were administered at least 1 dose of the Investigational Medicinal Product.|||Participants|||Count of Participants
2581220|NCT02395172|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity|Treatment Emergent Adverse Events were graded as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03). Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL), Grade 4 refers to Life-threatening consequences; where urgent intervention indicated, Grade 5 refers to the death related to adverse event.|Time from date of randomization up to data cutoff (assessed up to 907 days)|Safety analysis set included all participants who were administered at least 1 dose of the Investigational Medicinal Product.|||Participants|||Count of Participants
2581221|NCT02395172|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Drug Related Treatment Emergent Adverse Events and Treatment Emergent Adverse Events Leading to Death|An Adverse event (AE) was defined as any unfavorable and unintended sign (including clinically significant abnormal laboratory, vital signs and 12-lead Electrocardiogram findings), symptom, or disease temporally associated with the use of study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs.|Time from date of randomization up to data cutoff (assessed up to 907 days)|Safety analysis set included all participants who were administered at least 1 dose of the Investigational Medicinal Product.|||Participants|||Count of Participants
2581222|NCT02395172|Secondary|Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT)|EORTC QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, pain in chest, pain in arms or shoulder and pain in other parts. Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items).|Baseline, End of treatment visit (up to Week 124)|"HRQoL analysis set, a subset of the FAS and includes all FAS participants who had 1 baseline HRQoL assessment and at least 1 post-baseline health-related quality of life (HRQoL) questionnaire completed. Here, Number Analyzed signified those participants who were evaluable for the specified category."|||units on a scale||Standard Deviation|Mean
2581223|NCT02395172|Secondary|Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT)|EORTC QLQ-C30 was a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consisted of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). The EORTC QLQ-C30 GHS/QoL score ranged from 0 to 100; High score indicated better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.|Baseline, End of treatment visit (up to Week 124)|Health-related quality of life (HRQoL) analysis set wasa subset of the FAS and includes all FAS participants who had 1 baseline HRQoL assessment and at least 1 post-baseline HRQoL questionnaire completed. Here, “Overall Number of Participants Analyzed” signified the participants analyzed in this outcome.|||units on a scale||Standard Deviation|Mean
2581224|NCT02395172|Secondary|Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Visual Analogue Scale (VAS) at End of Treatment (EOT)|EQ-5D-5L is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive overall score using a visual analog scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 is the worst health you can imagine and 100 is the best health you can imagine.|Baseline, End of treatment visit (up to Week 124)|Health-related quality of life (HRQoL) analysis set was a subset of the FAS and includes all FAS participants who had 1 baseline HRQoL assessment and at least 1 post-baseline HRQoL questionnaire completed. Here, “Overall Number of Participants Analyzed” signified the participants analyzed in this outcome.|||millimeter||Standard Deviation|Mean
2581233|NCT02395172|Primary|Overall Survival (OS) Time in Programmed Death Ligand 1 (PD-L1) + Full Analysis Set Population (FAS)|The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates.|Time from date of randomization up to data cutoff (assessed up to 907 days)|PD-L1+ FAS included all PD-L1+ tumor participants who were randomly assigned to trial treatment. The PD-L1+ participants were with greater than or equal to (>=) 1 percentage (%) of tumor cells with >=1+ positive membrane staining intensity for PD-L1 protein.|||months||95% Confidence Interval|Median
2581225|NCT02395172|Secondary|Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score at End of Treatment (EOT)|The EQ-5D-5L health outcome questionnaire was a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L defined health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score. The lowest possible score is -0.59 (unable to walk, unable to self-care, unable to do usual activities, extreme pain or discomfort, extreme anxiety or depression) and the highest is 1.00 (no problems in all 5 dimensions).|Baseline, End of treatment visit (up to Week 124)|Health-related quality of life (HRQoL) analysis set was a subset of the FAS and includes all FAS participants who had 1 baseline HRQoL assessment and at least 1 post-baseline HRQoL questionnaire completed. Here, “Overall Number of Participants Analyzed” signified the participants analyzed in this outcome.|||units on a scale||Standard Deviation|Mean
2581226|NCT02395172|Secondary|Percentage of Participants With Objective Response in PD-L1+ Full Analysis Set Population|Percentage of participants with objective response (CR plus PR) according to RECIST Version 1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.|Time from date of randomization up to data cutoff (assessed up to 907 days)|PD-L1+ FAS included all PD-L1+ tumor participants who were randomly assigned to trial treatment. The PD-L1+ participants were with >= 1 percentage of tumor cells with >=1+ positive membrane staining intensity for PD-L1 protein.|||percentage of participants||95% Confidence Interval|Number
2581227|NCT02395172|Secondary|Percentage of Participants With Objective Response in Full Analysis Set Population|Percentage of participants with objective response (CR plus PR) according to RECIST Version 1.1 was reported. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions.|Time from date of randomization up to data cutoff (assessed up to 907 days)|Full analysis set (FAS) included all participants who were randomized to study treatment.|||percentage of participants||95% Confidence Interval|Number
2581228|NCT02395172|Secondary|Number of Participants With Confirmed Best Overall Response (BOR) in PD-L1+ Full Analysis Set Population|Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.|Time from date of randomization up to data cutoff (assessed up to 907 days)|PD-L1+ FAS included all PD-L1+ tumor participants who were randomly assigned to trial treatment. The PD-L1+ participants were with >= 1 percentage of tumor cells with >=1+ positive membrane staining intensity for PD-L1 protein.|||Participants|||Count of Participants
2581229|NCT02395172|Secondary|Number of Participants With Confirmed Best Overall Response (BOR) in Full Analysis Set Population|Confirmed BOR was determined according to RECIST 1.1 and as adjudicated by an IERC. Confirmed BOR was defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. Number of participants with best overall response in each category (CR, PR, SD, PD) was reported.|Time from date of randomization up to data cutoff (assessed up to 907 days)|Full analysis set (FAS) included all participants who were randomized to study treatment.|||Participants|||Count of Participants
2581230|NCT02395172|Secondary|Progression-Free Survival (PFS) Time in Full Analysis Set Population|PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates.|Time from date of randomization up to data cutoff (assessed up to 907 days)|Full analysis set (FAS) included all participants who were randomized to study treatment.|||months||95% Confidence Interval|Median
2581231|NCT02395172|Secondary|Progression-Free Survival (PFS) Time in PD-L1+ Full Analysis Set Population|PFS was defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD was defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions and unequivocal progression of non-target lesions. PFS was measured using Kaplan-Meier (KM) estimates.|Time from date of randomization up to data cutoff (assessed up to 907 days)|PD-L1+ FAS included all PD-L1+ tumor participants who were randomly assigned to trial treatment. The PD-L1+ participants were with >= 1 percentage of tumor cells with >=1+ positive membrane staining intensity for PD-L1 protein.|||months||95% Confidence Interval|Median
2581254|NCT02395055|Primary|Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 1680 Hours of Adalimumab After Single SC Injection of BCD-057/Humira.||0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose|All volunteers who received one adalimumab injection.|||(ng/ml)*hour||Inter-Quartile Range|Median
2581234|NCT02395133|Secondary|Percentage of Well-Controlled Weeks During the On-treatment Period|Well-controlled weeks are those in which participants during their weekly IVRS call completion has their eczema been well-controlled over the last week during which no rescue treatments were administered. Percentage of well-controlled weeks during the on-treatment period were reported.|Baseline through Week 36|The safety analysis set (SAF) included all randomized participants who received any amount of study drug. Here, number of participants analyzed = participants with available data for this endpoint. One participant was randomized to Dupilumab Q2W/QW, but treated per Dupilumab Q4W arm and included in SAF.|||percentage of weeks||Standard Deviation|Mean
2581235|NCT02395133|Secondary|Annualized Event Rate of Flares|Rate of Flares defined as worsening of disease requiring initiation or escalation of rescue treatment.|Baseline through week 36|FAS population was used.|||events per year||95% Confidence Interval|Median
2581236|NCT02395133|Secondary|Annualized Event Rate of Skin Infection Treatment- Emergent Adverse Events (TEAEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment- emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on- treatment period (time from the first dose of study drug up to the end of study [Week 36]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline through Week 36|FAS population was used.|||events per year||95% Confidence Interval|Median
2581237|NCT02395133|Secondary|Difference Between Current Study Baseline and Week 35 in Percent Change in Peak Weekly Pruritus NRS From Parent Study Baseline|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Values after first rescue treatment used were set to missing before MI.|Baseline (Parent Study), Baseline (Current Study) and Week 35 (Current study)|FAS population was used.|||percent change||Standard Error|Least Squares Mean
2581238|NCT02395133|Secondary|Difference Between Current Study Baseline and Week 36 in Percent Change in SCORAD From Parent Study Baseline|SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). Values after first rescue treatment used were set to missing before MI.|Baseline (Parent Study), Baseline (Current Study) and Week 36 (Current study)|FAS population was used.|||Percent change||Standard Error|Least Squares Mean
2581239|NCT02395133|Secondary|Absolute Change From Baseline in Hospital Anxiety Depression Scale (HADS) Through Week 36|HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression. Values after first rescue treatment used were set to missing before MI.|Baseline through Week 36|FAS population was used.|||units on a scale||Standard Error|Least Squares Mean
2581240|NCT02395133|Secondary|Absolute Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 36|The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL. Values after first rescue treatment used were set to missing before MI.|Baseline through Week 36|FAS population was used.|||units on a scale||Standard Error|Least Squares Mean
2581241|NCT02395133|Secondary|Absolute Change From Baseline Through in Patient Oriented Eczema Measure (POEM) Through Week 36|The POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]). Values after first rescue treatment used were set to missing (censoring) before MI.|Baseline through Week 36|FAS population was used.|||units on a scale||Standard Error|Least Squares Mean
2581242|NCT02395133|Secondary|Absolute Change From Baseline in Body Surface Area (BSA) Through Week 36|BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined. Values after first rescue treatment used were set to missing (censoring) before MI.|Baseline through Week 36|FAS population was used.|||meter square||Standard Error|Least Squares Mean
2581243|NCT02395133|Secondary|Absolute Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score at Week 35|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Values after first rescue treatment used were set to missing before MI.|Baseline, Week 35|FAS population was used.|||units on a scale||Standard Error|Least Squares Mean
2581244|NCT02395133|Secondary|Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 36|SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). Values after first rescue treatment used were set to missing (censoring) before MI.|Baseline, Week 36|FAS population was used.|||units on a scale||Standard Error|Least Squares Mean
2581245|NCT02395133|Secondary|Absolute Change From Baseline in Eczema Area and Severity Index (EASI) at Week 36|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Values after first rescue treatment were set to missing and participants with missing Values at Week 36 were imputed by using multiple imputation method.|Baseline, Week 36|FAS population was used.|||units on a scale||Standard Error|Least Squares Mean
2581246|NCT02395133|Secondary|Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (>= 50% Reduction in EASI Score) at Week 36|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved >= 50% overall improvement in EASI score from baseline to Week 36. Values after first rescue treatment were set to missing and participants with missing EASI-50 scores at Week 36 were considered as non-responders.|Week 36|FAS population was used.|||percentage of participants|||Number
2581247|NCT02395133|Secondary|Percentage of Participants With Increased Investigator's Global Assessment (IGA) Score 3 or 4 at Week 36|IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 36 were considered as responders (i.e. having a increase 3 or 4 of IGA value).|Week 36|FAS population was used. Here, number of participants analyzed = participants with IGA 0 or 1 at Baseline from IVRS.|||percentage of participants|||Number
2581248|NCT02395133|Secondary|Time to First Event of Investigator's Global Assessment (IGA) >= 2 for Participants With IGA 0 or 1 at Baseline|IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear).|Baseline up to Week 36|FAS population was used. Here, number of participants analyzed = participants with IGA 0 or 1 at Baseline from IVRS.|||Days||95% Confidence Interval|Median
2581249|NCT02395133|Secondary|Percentage of Participants With Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score Increased by 3 or More Points From Baseline to Week 35|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 35 were considered as non-responders.|Baseline up to Week 35|FAS population was used. Here, number of participants analyzed = participants with NRS <= 7 at Baseline.|||percentage of participants|||Number
2581250|NCT02395133|Secondary|Percentage of Participants Maintaining Investigator Global Assessment (IGA) Response at 0 or 1 Point at Week 36|IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of 0 or 1 at week 36 were reported as responders. Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 36 were considered as non-responders.|Week 36|FAS population was used. Here, number of participants analyzed = participants with IGA 0 or 1 at Baseline from IVRS.|||percentage of participants|||Number
2581251|NCT02395133|Secondary|Percentage of Participants Maintaining Investigator Global Assessment (IGA) Response Within 1 Point of Baseline at Week 36|IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of 0 or 1 at baseline and maintaining within 1 point of baseline were reported as responders. Values after first rescue treatment used were set to missing. Participants with missing value at a visit were considered as a non-responder.|Baseline, Week 36|FAS population was used. Here, number of participants analyzed = participants with IGA 0 or 1 at Baseline from Interactive voice response system (IVRS).|||percentage of participants|||Number
2581252|NCT02395133|Primary|Percentage of Participants With Eczema Area and Severity Index >= 75% [EASI-75] at Baseline of Current Study Maintaining EASI-75 at Week 36|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved >=75% overall improvement in EASI score at Week 36. Values after first rescue treatment used were set to missing. Patients with missing value at week 36 were considered as a non-responder.|Week 36|FAS population was used. Here, number of participants analyzed = participants with EASI-75 at baseline.|||percentage of participants|||Number
2581253|NCT02395133|Primary|Difference Between Current Study Baseline and Week 36 in Percent Change in EASI From Parent Study Baseline (NCT02277743 and NCT02277769)|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Difference of percent change in EASI between current study baseline and week 36 in from parent study baseline (NCT02277743 and NCT02277769) was reported. Values after first rescue treatment used were set to missing before multiple imputation (MI).|Baseline (Parent Study), Baseline (Current Study) and Week 36 (Current study)|The full analysis set (FAS) includes all randomized participants.|||percent change||Standard Error|Least Squares Mean
2581255|NCT02395055|Primary|Area Under the Plasma Concentration-time Curve From Zero (0) to Time Infinity||0, 6, 24, 48, 72, 96, 120, 144, 168, 192, 336, 672, 1008, 1440, 1680 hours post-dose|All patients who received adalimumab injection.|||(ng/ml)*hour||Inter-Quartile Range|Median
2581257|NCT02395042|Secondary|Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions|A standardized video capture protocol for bladder mapping was followed to assess any changes in the number, the size and the severity, of lesions during the study as a result of treatment. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Week 4|Data for the planned composite Hunner’s Lesions score were supposed to be generated based on digital images by a software algorithm, but the system never worked and no data were generated.||||||
2581258|NCT02395042|Secondary|Change From Baseline in the Number of Hunner's Lesions|During each cystoscopy, the investigator counted the number of lesions visible while performing the bladder scan. A negative change from Baseline indicates improvement (less lesions). An ANCOVA model with Baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors was used for analysis.|Baseline (Day 0) to Week 4|Modified Intent-to-Treat population, all participants who were randomized and received Treatment 1, with data available for analysis.|||Hunner's lesions||90% Confidence Interval|Least Squares Mean
2581259|NCT02395042|Primary|Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS)|The participant recorded their daily bladder pain score over the previous 24-hour period on a 7-day pain assessment tool as measured by an NRS on an 11-point scale where 0=no pain to 10=worst pain imaginable. The daily pain scores over the 7-day period were averaged. A negative change from Baseline indicates improvement. An analysis of covariance (ANCOVA) model with Baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors was used for analysis.|Baseline (Day -7 to Day 0) to Week 4|Modified Intent-to-Treat population, all participants who were randomized and received Treatment 1, with data available for analysis.|||score on a scale||90% Confidence Interval|Least Squares Mean
2581260|NCT02394951|Secondary|Number of Patients With Significant Pain Reduction|Number of patients who experienced 50% or more reduction in average daily pain (on 0-10 NRS, Numerical Rating Scale, where 0=least pain, 10=worst pain)|Baseline to week 4||||Participants|||Count of Participants
2581261|NCT02394951|Secondary|Change in BPI Outcomes (INTERFERENCE)|Change from baseline to week 4 in BPI (Brief Pain Inventory) pain interference score BPI interference score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain interference|baseline to week 4||||units on a scale (0-10 BPI interference)||Standard Deviation|Mean
2581262|NCT02394951|Secondary|Change in Sleep Problem Index (SPI) Outcomes|Change from baseline to week 4 in SPI (Sleep Problem Index) score, on 0-100 scale, where 0= best (least) score, and 100= maximum (worst) score|Baseline to week 4||||units on a scale (0-100 SPI)||Standard Deviation|Mean
2581263|NCT02394951|Secondary|Change in BPI Outcomes (SEVERITY)|Change from baseline to week 4 in BPI (Brief Pain Inventory) pain severity severity score BPI severity score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain severity|Baseline to week 4||||units on a scale (0-10 BPI severity)||Standard Deviation|Mean
2581264|NCT02394951|Secondary|Change in NPSI Outcomes|Change from baseline to week 4 in total NPSI (Neuropathic Pain Symptom Inventory) score The total NPSI score is comprised by adding 5 sub-scores (Burning pain, Pressing pain, Paroxysmal pain, Evoked pain, and Paresthesia/Dysesthesia) and is expressed on a 0-100 scale; 0-minimum (least), and 100 maximum (worst) score|Baseline to week 4||||units on a scale (0-100 NPSI score)||Standard Deviation|Mean
2581265|NCT02394951|Secondary|Absolute Change in Pain Intensity, Measured on 0-10 Numerical Rating Scale (NRS)|Absolute change in pain intensity on 0-10 numerical rating scale (NRS) from baseline to 4 weeks with pregabalin vs. placebo NRS: 0= no pain, 10= worst pain|Baseline to week 4||||units on a scale (0-10 NRS)||Standard Deviation|Mean
2581266|NCT02394951|Primary|Change in Spontaneous Pain Intensity as a Function of Baseline MPT|Correlation between Mechanical Pain Threshold (MPT in mN) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at the end of 4-week treatment. The slopes (Pearson coefficients) of the correlation obtained from pregabalin vs. placebo will be compared.|Baseline to week 4||||Pearson correlation coefficient||95% Confidence Interval|Number
2581267|NCT02394925|Primary|Proportion of Successful Contact Lens Wearers|"Proportion of Successful contact lens wearers is based on a subject's responses to two questionnaire items, Overall Quality of Vision and Overall Comfort. Each item uses a 6 response like-rt scale (0= Not Applicable, 1=Excellent, 2=Very Good, 3=Good, 4=Fair and 5=Poor). The data from each item was dichotomized into two groups. If a subject responded Excellent, Very Good or Good then the response=1, otherwise the response=0. The proportion of subjects with response=1 was reported as the proportion of successful contact lens wearers."|2 months post wear|Subjects that completed all study visits without a major protocol deviation.|||Proportion of Subjects|||Number
2581268|NCT02394912|Primary|Technical Success Rate|"All Subjects, Cohort A and Cohort B were included in the safety analysis. The primary endpoint of effectiveness, defined as technical success included only subjects within Cohort B. Technical success of filter placement is defined as the primary deployment of the filter such that the investigator judges the location to be suitable to provide sufficient mechanical protection against pulmonary embolism.~Due to early stoppage of the study, enrollment of 100 subjects required to test the null hypothesis and evaluate the Primary Endpoint of Technical Success was not achieved. Therefore, a formal analysis of Technical Success was not performed."|Day 1||||Participants|||Count of Participants
2581269|NCT02394808|Primary|Subjective Overall Quality of Vision|Subjective Overall quality of Vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|11 days post fit|Subjects that completed all study visits without a major protocol deviation.|||units on a scale||Standard Deviation|Mean
2581328|NCT02393950|Primary|Number of Participants With Adverse Events as a Measure of Safety. Number of Participants With Adverse Events Related to Tolerability.|Clinically relevant changes from baseline in safety laboratory assessments (haematology, clinical chemistry, urinalysis), vital signs (pulse and heart rate), 12 lead electrocardiograms, Holter electrocardiograms, telemetry, physical examination.|From screening up to 16 weeks||||subjects affected|||Number
2581329|NCT02393677|Other Pre-specified|Complications||2 hours|||||||
2581270|NCT02394808|Primary|Subjective Overall Comfort|Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|11 days Post fit|Subjects that completed all study visits without a major protocol deviation.|||units on a scale||Standard Deviation|Mean
2581271|NCT02394756|Primary|Subjective Overall Quality of Vision|Subjective Overall quality of vision was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. Scores range 0-120.|1-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.|||units on a scale||Standard Deviation|Mean
2581272|NCT02394756|Primary|Subjective Overall Comfort|Subjective Overall Comfort was evaluated using the Contact Lens User Experience Comfort scores (CLUE). CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. Scores range 0-120.|1-Day Follow-up|Subjects that completed all study visits without a major protocol deviation.|||units on a scale||Standard Deviation|Mean
2581273|NCT02394730|Secondary|Changes From Baseline in Renal Function Measured by the CKD-EPI Estimate of Creatinine Clearance at Week 12|Changes from baseline in renal function measured by the CKD-EPI estimate of creatinine clearance at week 12|at week 12||||ml/min/1.73m2||Standard Deviation|Mean
2581274|NCT02394730|Secondary|Total Number of Participants With Any AE Between Baseline to Week 18|Total number of participants with any AE between week 0 to week 18|week 18||||Participants|||Count of Participants
2581275|NCT02394730|Secondary|Total Number of Participants With Any SAE Between Baseline and Week 18|Total number of participants with any SAE between baseline and week 18|week 18||||Participants|||Count of Participants
2581276|NCT02394730|Secondary|Total Number of Participants With BARC Type 1, 2, 3, 4, or 5 Bleeding Episodes|Bleeding Academic Research Consortium (BARC) Definitions for Bleeding Events Type 1 -bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies, hospitalization, or treatment by a healthcare professional; may include episodes leading to self-discontinuation of medical therapy by the patient without consulting a healthcare professional Type 2 - overt, actionable sign of haemorrhage (eg, more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for type 3, 4, or 5 but does meet at least one of the following criteria: (1) requiring nonsurgical, medical intervention by a healthcare professional, (2) leading to hospitalization or increased level of care, or (3) prompting evaluation Type 3- Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid) Type 4 - Coronary Artery Bypass Graft procedure-related bleeding Type 5 -|at week 18||||Participants|||Count of Participants
2581277|NCT02394730|Secondary|Differences Between Treatment Groups in Mean Change From Baseline log10 IL-6|Differences between treatment groups in mean change from baseline log10 IL-6 at week 18|at week 18||||pg/mL||Standard Deviation|Mean
2581278|NCT02394730|Secondary|Mean Percent Change From Baseline IL-6 (pg/mL) to the Average of Week 8 and Week 12|Mean of week 8 and week 12 minus week 0 (on log10 scale) then back transformed the log10 difference to obtain percentage change from baseline.|at week 8 and week 12||||percent||90% Confidence Interval|Mean
2581279|NCT02394730|Secondary|Percent Change From Baseline Hs-CRP (ug/mL) to the Average of Week 8 and Week 12|Mean of week 8 and week 12 minus week 0 (on log10 scale) then back transformed the log10 difference to obtain percentage change from baseline.|week 8 and 12||||Percent||95% Confidence Interval|Mean
2581280|NCT02394730|Secondary|Mean Change From Baseline in log10 Hs-CRP at Week 18|Differences between treatment groups in mean change from baseline log10 hs-CRP to week 18. ie Week 18 log10 hs-CRP minus week 0 log10 hs-CRP|at week 18||||pg/mL||Standard Deviation|Mean
2581281|NCT02394730|Secondary|Mean Change From Baseline in log10 D-Dimer|Differences between treatment groups in mean change from week 0 log10 d-dimer to week 18|at week 18||||percent change||95% Confidence Interval|Mean
2581282|NCT02394730|Secondary|Number of Patients in Each Treatment Group With D-dimer > or Equal to 165ng/mL at Week 18|Number of patients in each treatment group with d-dimer > or equal to 165ng/mL at week 18|week 18||||Participants|||Count of Participants
2581283|NCT02394730|Secondary|Number of Patients in Each Treatment Group With D-dimer <165ng/mL at Week 12|Number of patients in each treatment group with d-dimer <165ng/mL at week 12|week 12||||Participants|||Count of Participants
2581284|NCT02394730|Secondary|Mean Change From Baseline to Week 12 in CD8+ Cell Counts|Mean of week 12 CD8+ cell count minus mean of week 0 CD4+ cell count|at week 12||||cells/mm3||Standard Deviation|Mean
2581285|NCT02394730|Secondary|Mean Change From Baseline to Week 12 in CD4+ Cell Counts|Mean of week 12 CD4+ cell count minus mean of week 0 CD4+ cell count|at week 12||||cells/mm3||Standard Deviation|Mean
2581286|NCT02394730|Secondary|Number of Participants in Each Treatment Group With Plasma HIV-1 RNA <50 Copies/mL|Number of participants in each treatment group with plasma HIV-1 RNA <50 copies/mL at week 18|at week 18||||Participants|||Count of Participants
2581287|NCT02394730|Primary|Mean Percent Change From Baseline for D-dimer (ng/mL) to the Average of Weeks 8 and 12|Mean of week 8 and week 12 minus week 0 (on log10 scale) then back transforming the log10 difference to obtain percentage change from baseline.|at week 8 and week 12||||percent||95% Confidence Interval|Mean
2581330|NCT02393677|Other Pre-specified|Haemodynamic Changes||8 hours|||||||
2581331|NCT02393677|Secondary|Duration of Motor Block||6 hours|||||||
2581332|NCT02393677|Secondary|Onset of Motor Block||30minutes|||||||
2581333|NCT02393677|Secondary|Onset of Sensory Block||20 minutes|||||||
2581334|NCT02393677|Primary|Duration of Analgesia||upto 8 hours||||minutes||Standard Deviation|Mean
2581288|NCT02394665|Secondary|Patterns of Failure in Study Participants Post-Protocol Therapy|Patterns of Failure will be assessed by determining the number of failures that arise in-field compared to the number that arise out-of-field. In-field failure will be defined as those where greater than 80% of the recurrence volume was encompassed by the 95% prescription isodose line. In addition, we will also describe failures by three types: unifocal, multifocal and diffuse (multicentric including leptomeningeal dissemination).|Up to 2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.||||||
2581289|NCT02394665|Secondary|Change in Quality of Life From Baseline in Study Participants|Change in quality of life during radiation and across the longitudinal progression-free interval compared to baseline. Change of quality of life will be assessed and scored via the FACT-Br behavioral questionnaire.|Up to 2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.||||||
2581290|NCT02394665|Secondary|Rate of Grade 3 or Higher Toxicity as a a Consequence of Study Therapy.|Rate of Grade 3 of Higher Toxicity in study participants as a consequence of study therapy.|2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.||||||
2581291|NCT02394665|Secondary|Rate of Progression-Free Survival (PFS) in Study Patients|Rate of progression-free survival in study participants. Progression-free survival (PFS) is defined as the time elapsed from the start of study treatment to the date of documented progression events. For progression-free patients (without progression events), PFS will be censored at the last date of documented PF status.|Up to 2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.||||||
2581292|NCT02394665|Primary|Rate of Overall Survival (OS) in Study Patients|The efficacy of 3D MRSI-guided, dose escalated radiation in newly diagnosed glioblastoma (GBM) patients as measured by overall survival (OS). Overall survival (OS) is defined as the time elapsed from the start of study treatment until death. Surviving patients (including patients lost to follow up) will be censored at the date of last contact.|Up to 2 years|Data were not analyzed due to insufficient number of evaluable subjects. Only one subject enrolled who was later withdrawn by the Investigator prior to assignment to any treatment group or receiving any protocol therapy.||||||
2581293|NCT02394600|Secondary|Analysis of Blood Samples for Potential Biomarkers by Comparing Baseline and Post-treatment Samples.|To determine potential biomarkers predictive of clinical efficacy for birch pollen-induced AR following treatment with Grastek®|4 months|As the primary outcome showed that there was no significant difference between Grastek and placebo this outcome was not able to be completed.||||||
2581294|NCT02394600|Primary|Change in Total Nasal Symptom Score (TNSS) From Baseline to Post-treatment.|"To determine the effect of 4 months of treatment with Grastek® on the symptoms of birch pollen induced AR in participants with both timothy grass pollen-induced and birch pollen-induced allergen rhinitis (AR)~TNSS is comprised of the sum of 4 symptoms: runny nose, itchy nose sneezing and nasal congestion. Each of these symptoms are evaluated based on a 4 point Likert scale from 0-3. 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms. TNSS can therefore have a range from 0 to 12."|4 months|93 participants were randomized into this study. The final number of participants that completed and were included for analysis are listed above.|||Scores on a scale||95% Confidence Interval|Mean
2581295|NCT02394561|Secondary|Changes From Baseline in Weight (Safety Set)|Change in weight from baseline for patients with a value at baseline and the respective post-baseline visit|Baseline up to approximately 72 weeks|Number of patients varied across visits|||kg||Standard Deviation|Mean
2581296|NCT02394561|Secondary|Changes From Baseline in Waist Circumference (Safety Set)|Change in waist circumference from baseline for patients with a value at baseline and the respective post-baseline visit|Baseline up to approximately 72 weeks|Number of patients varied across visits|||cm||Standard Deviation|Mean
2581297|NCT02394561|Secondary|Changes From Baseline in Body Mass Index (Safety Set)|Change in Body mass index from baseline for patients with a value at baseline and the respective post-baseline visit|Baseline up to approximately 72 weeks|Number of patients varied across visits|||kg/m2||Standard Deviation|Mean
2581298|NCT02394561|Secondary|Correlation Between the Hospital Anxiety and Depression Scale (HADS) and PASI (FAS)|PASI score, HADS questionnaire correlation using Spearman rank correlation coefficient. It was pre-specified that results would be presented for all patients, not by cohort|Baseline up to approximately 72 weeks|Both arms were combined because there is no clinical rationale to show a difference between the cohorts. Cw6 status does not have any impact on anxiety and depression.|||numbers on scores|||Number
2581299|NCT02394561|Secondary|Change From Baseline in Mean Scores of HAD-A and HAD-D (Anxiety and Depression) (LOCF) (FAS)|The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale.. Seven of the items relate to anxiety and seven relate to depression. This outcome measure was specifically developed to avoid reliance on aspects of these conditions that are also common somatic symptoms of illness, for example fatigue and insomnia or hypersomnia. Calculations of scores: each of the 14 items was rated on a 4-point scale. All items except 7 and 10 were scored as Yes, definitely = 3, Yes, sometimes = 2, No, not much = 1, to No, not at all = 0. Items 7 and 10 were scored as Yes, definitely = 0 to No, not at all = 3 in the reverse order. The HADS consisted of two sub-scores: the HAD-A (anxiety) and HAD-D (depression); each sub-score ranged from 0 to 21 points; scores ≥11 = presence of anxious or depressive disorders; scores between 8-10 points = borderline abnormal, and scores of ≤7 = disorder was not present. It was pre-specified that results would be presented for all patients, not by cohort|Baseline up approximately 72 weeks|Number of patients varies by visit. Both arms were combined because there is no clinical rationale to show a difference between the cohorts. Cw6 status does not have any impact on anxiety and depression.|||numbers on a scale||Standard Deviation|Mean
2581335|NCT02393547|Secondary|BMI|Change in BMI from baseline to week 12|12 weeks|subjects (N=10) who met criteria for prolonged smoking abstinence at week 12|||kg/m^2||Standard Deviation|Mean
2581336|NCT02393547|Secondary|Smoking Abstinence Rates|prolonged smoking abstinence at week 12|12 weeks||||Participants|||Count of Participants
2581300|NCT02394561|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI) (LOCF) (FAS)|The DLQI total score was calculated by summing the score of each domain resulting in a maximum of 30 and a minimum of 0. The higher the score, the more Quality of Life was impaired. Meaning of DLQI Scores: 0-1 = no effect at all on patient's life, 2-5 = small effect on patient's life, 6-10 = moderate effect on patient's life, 11-20= very large effect on patient's life, 21-30 = extremely large effect on patient's life. It was pre-specified that results would be presented for all patients, not by cohort|Baseline up to approximatly 72 weeks|Number of patients varied across visits. Both arms were combined because there is no clinical rationale to show a difference between the cohorts. Cw6 status does not have any impact on Quality of Life.|||numbers in a score||Standard Deviation|Mean
2581301|NCT02394561|Secondary|Median Time to Reach PASI 90 and 75 (ITT)|Time in days to reach PASI scores of 90 and 75.|Baseline up to approximately 72 weeks||||days||Inter-Quartile Range|Median
2581302|NCT02394561|Secondary|Percent Mean Changes From Baseline in IGA Mod 2011 Between Cohorts at Each Time Point (LOCF) (ITT)|IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe').|Baseline up to approximately 72 weeks|The number of patients across visits varied|||percent change||Standard Deviation|Mean
2581303|NCT02394561|Secondary|Percentage (%) of Patients With IGA 0/1, PASI 50, PASI 75, PASI 90, PASI 100 Responders by Visit - LOCF Approach (ITT Set)|IGA mod 2011 scale measures severity of the psoriasis on a five-point scale ranging from 0 (no disease, 'clear') to 4 ('very severe'). PASI 50,75,90,100 represent: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline, ≥ 75% improvement (reduction), ≥ 90% improvement (reduction) and PASI 100 response/remission: complete clearing of psoriasis (PASI=0).|Baseline up to approximately 72 weeks|Number of patients varied across visits|||percentage of participants||95% Confidence Interval|Number
2581304|NCT02394561|Primary|Percentage (%) of Patients Who Reach Psoriasis Area Severity Index (PASI) 90 at 16 Weeks - LOCF Approach (ITT Set)|PASI (Langley et al 2015) combines the assessment of the severity of lesions and the area affected into a single score with a range of 0 (no disease) to 72 (maximal disease). The PASI was assessed at all visits in CORE and extension phases. PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline are defined as PASI 90 responders.|Baseline up to 16 weeks||||percentage of participants||95% Confidence Interval|Number
2581305|NCT02394548|Secondary|Median Survival Time|Follow-up time will be calculated from the date of registration to the date of death or the last follow-up date on which the patient was reported alive. Median survival time will be estimated using the Kaplan-Meier method.|2 Years|||||||
2581306|NCT02394548|Secondary|Overall Survival Rate|Follow-up time will be calculated from the date of registration to the date of death or the last follow-up date on which the patient was reported alive. Overall survival rates will be estimated using the Kaplan-Meier method.|2 Years|||||||
2581307|NCT02394548|Secondary|Rate of Local and Regional Failure|Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline|2 Years|||||||
2581308|NCT02394548|Secondary|Number of Participants With Adverse Events|Adverse events will be measured using CTCAE v4 scoring scale|Baseline, up to 2 Years||||Participants|||Count of Participants
2581309|NCT02394548|Secondary|Number of Participants With Grade 3 or Higher Acute Esophagitis (RTOG)|Esophagitis will be measured using the historical Radiation Therapy Oncology Group (RTOG) scoring scale|Baseline , up to 3 Months||||Participants|||Count of Participants
2581310|NCT02394548|Primary|Number of Participants With Grade 3 or Higher Acute Esophagitis (CTCAE)|Esophagitis will be measured using the Common Toxicity Criteria for Adverse Effects (CTCAE) v4 scoring scale|up to 3 months||||Participants|||Count of Participants
2581311|NCT02394457|Secondary|Functioning Score|Functional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete ADLs|7 day post procedure||||units on a scale||Standard Deviation|Mean
2581312|NCT02394457|Secondary|Functioning Score|Functional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete ADLs|3 day post procedure||||units on a scale||Standard Deviation|Mean
2581313|NCT02394457|Secondary|Functioning Score|Functional score 0-10 (0 being able to function all tasks of daily living, 10 not able to complete activities of daily living (ADLs)|1 day post procedure||||units on a scale||Standard Deviation|Mean
2581314|NCT02394457|Primary|Headache Pain Score|Numerical 0-10 (0 no pain, 10 worst pain)|7 days post procedure||||units on a scale||Standard Deviation|Mean
2581315|NCT02394457|Primary|Headache Pain Score|Numerical 0-10 (0 no pain, 10 worst pain)|3 days post procedure||||units on a scale||Standard Deviation|Mean
2581316|NCT02394457|Primary|Headache Pain Score|Numerical 0-10 (0 no pain, 10 worst pain)|1 day post procedure||||units on a scale||Standard Deviation|Mean
2581317|NCT02394340|Primary|Circulating Levels (Plasma Concentration) of Omeprazole After 1 Week of Treatment With Luliconazole Cream 1%|Circulating plasma levels of omeprazole were measured using validated LS/MS-MS methods. The range for omeprazole determination was 4.64-9.27 ng/mL. Serial blood sampling occurred in each enrolled participant up to 24 hours post treatment (Day 8) with omeprazole (after using luliconazole cream 1% treatment for 1 week).|15 minutes predose; 15, 30, 45, and 60 minutes postdose; and 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose of omeprazole on Day 8|Randomized participants who received at least 1 dose of study drug and had evaluable data at the specified time point.|||ng/mL||Standard Deviation|Mean
2581318|NCT02394340|Primary|Circulating Levels (Plasma Concentration) of Omeprazole Prior to Treatment With Luliconazole Cream 1%|Circulating plasma levels of omeprazole were measured using validated liquid chromatography with tandem mass spectrometry detection (LS/MS-MS) methods. The range for omeprazole determination was 4.64-9.27 nanograms/milliliter (ng/mL). Serial blood sampling occurred in each enrolled participant up to 24 hours post treatment (Day 1) with omeprazole (before the start of luliconazole cream 1% treatment on Day 2).|15 minutes predose; 15, 30, 45, and 60 minutes postdose; and 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 24 hours postdose of omeprazole on Day 1|Randomized participants who received at least 1 dose of study drug and had evaluable data at the specified time point.|||ng/mL||Standard Deviation|Mean
2581319|NCT02393950|Secondary|Quantitative EEG|Quantitative analysis of EEG|Pre-dose and at 1, 6 and 10 h post dose at each dose level|||||||
2581320|NCT02393950|Secondary|Dexterity and Reaction Times|Selected battery of psychomotor tests|Pre-dose and at 1 and 6h post dose at each dose level|||||||
2581339|NCT02393417|Other Pre-specified|The Effect of the Treatment History on the Number of Recurrences of Resolved Primary Warts||45 weeks|mITT - Subjects that received at least one post baseline measurement of the primary wart(s). A subject may belong to more than one prior treatment types. As defined in the Statistical Analysis Plan, Cohorts 1 and 3 were combined for this exploratory endpoint (0.3 mL injected into each wart)|||Number of warts|||Number
2581340|NCT02393417|Other Pre-specified|Summary of Complete Resolution of the Largest Primary Wart and Type of Treatment History|Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart|45 weeks|mITT- Subjects that received at least one post baseline measurement of the primary wart(s). A subject may belong to more than one prior treatment types. As defined in the Statistical Analysis Plan, Cohorts 1 and 3 were combined for this exploratory endpoint (0.3 mL injected into each wart)|||Participants|||Count of Participants
2581341|NCT02393417|Other Pre-specified|Association Between the Age of the Primary Injected Wart and the Recurrence of Any Resolved Wart at Any Visit.||45 weeks|mITT - subjects that received at least one post baseline measurement of the primary wart(s)|||wart recurrences|||Number
2581342|NCT02393417|Other Pre-specified|Association Between the Age of the Largest Primary Injected Wart and Complete Resolution of the Largest Primary Injected Wart|Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart|45 weeks|mITT- Subjects that received at least one post baseline measurement of the primary wart(s)|||number of warts resolved|||Number
2581343|NCT02393417|Secondary|Number of Subjects With Injection Site Reactions With Frequency Greater Than 5%||45 weeks|Safety Population- All randomized subjects who received at least one intralesional dose of study medication. Subjects experiencing multiple types of reactions were counted once for each type, but only once across all reactions.|||participants|||Number
2581344|NCT02393417|Secondary|Number of Subjects With Hypopigmentation at the Site of Resolved Primary and Non-primary Injected Wart(s)||45 weeks|Only mITT subjects with complete resolution of warts included in this endpoint|||Participants|||Count of Participants
2581345|NCT02393417|Secondary|Number of Subjects With Scarring at the Site of Resolved Primary and Non-primary Injected Wart(s)|Scarring at any visit, many reports were transient being noted at only one or two visits and noted as resolving during the course of the study|45 weeks|mITT - Subjects that received at least one post baseline measurement of the primary wart(s)|||Participants|||Count of Participants
2581346|NCT02393417|Secondary|Number of Injection Visits to >50% Reduction in the Total Area of All Measured Warts||45 weeks|mITT - Subjects that received at least on post baseline measurement of the primary wart(s)|||injection visits||95% Confidence Interval|Median
2581347|NCT02393417|Secondary|Number of Injection Visits for >50% Reduction in Area of the Primary Injected Wart(s)||45 weeks|mITT - Subjects that received at least one post baseline measurement of the primary wart(s)|||injection visits||95% Confidence Interval|Median
2581348|NCT02393417|Secondary|Number of Injection Visits Needed to Obtain Complete Resolution of the Primary Injected Wart(s)|Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart|45 weeks|mITT. Subjects that received at least one post baseline measurement of the primary wart(s). Cohort 3 values represent resolution of largest primary wart|||injection visits||95% Confidence Interval|Median
2581349|NCT02393417|Secondary|Number of Subjects With Complete Resolution of Primary Injected Wart(s) at the 4 Month Follow-up Visit|Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart|4 month follow up visit at 45 weeks|mITT - Subjects that received at least one post baseline measurement of the primary wart(s)|||Participants|||Count of Participants
2581350|NCT02393417|Secondary|Number of Subjects With a Complete Resolution of All Common Warts at Any Treatment or Follow-up Visit|Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart|45 weeks|mITT - Subjects that received at least one post baseline measurement of the primary wart(s)|||Participants|||Count of Participants
2581351|NCT02393417|Primary|Number of Subjects With Complete Resolution of a Primary Injected Wart(s) at Any Treatment or Follow-up Visit|Complete resolution of a wart was defined as the absence of visible or measurable presence of the wart|45 weeks|Modified Intent to Treat (mITT) - subjects that received at least one post baseline measurement of the primary wart(s)|||Participants|||Count of Participants
2581352|NCT02393378|Secondary|Change From Baseline in DAS28-CRP Score|The DAS28-CRP is a composite measure of inflammation in RA and incorporates a tender and swollen joint count, CRP and patient global assessment of disease activity expressed in a gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤3.2 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores.|Baseline Up to Week 42|Full analysis set included participants who received at least one dose of study medication. Here number analyzed is the number of participants who were evaluated at specific time point.|||score on a scale||Standard Deviation|Mean
2581353|NCT02393378|Secondary|Number of Participants Who Achieved ACR 20, 50, and 70 at Week 24|The American College of Rheumatology (ACR) 20 is composite index of improvement in RA proposed by the ACR. ACR20 refers to a composite improvement of 20% in swollen joint count, tender joint count, and 3 or more of the following 5 measures: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient Pain VAS, Patient's self-addressed disability (HAQ), Acute-phase reactant (ESR or CRP) The ACR 50 and ACR 70 are similar tools, used to indicate 50% and 70% improvement, respectively.|Week 24|Full analysis set included participants who received at least one dose of study medication.|||Participants|||Count of Participants
2581369|NCT02393209|Secondary|Disease Control Rate in Phase 2|Disease control rate is defined as percentage of participants with CR + PR + stable disease (SD). According to RECIST: CR is defined as disappearance of all target lesions, PR is defined as 30% decrease in the sum of the longest diameter of target lesions and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter (LD) since the treatment started.|Approximately 12 months in Phase 2|Data was not analyzed as Phase 2 of the study was cancelled.||||||
2581354|NCT02393378|Secondary|Number of Participants Who Achieved Low Disease Activity at Week 24|Disease Activity Score 28 based on C-reactive protein (DAS28-CRP) low disease activity is defined as a score <3.2. The DAS28-CRP is a composite measure of inflammation in RA and incorporates a tender and swollen joint count, CRP and patient global assessment of disease activity expressed in a gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤2.6 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores.|Week 24|Full analysis set included participants who received at least one dose of study medication.|||Participants|||Count of Participants
2581355|NCT02393378|Secondary|Number of Participants Who Achieved Remission at Week 24|Remission is defined as the number of participants who achieved Disease Activity Score 28 based on C-reactive protein (DAS28-CRP) score <2.6. The DAS28-CRP is a composite measure of inflammation in rheumatoid arthritis (RA) and incorporates a tender and swollen joint count, CRP and patient global assessment of disease activity expressed in a gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤2.6 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores.|Week 24|Full analysis set included participants who received at least one dose of study medication.|||Participants|||Count of Participants
2581356|NCT02393378|Secondary|Change From Baseline in Dynamic Contrast-enhanced - Magnetic Resonance Imaging (DCE-MRI) Parameters at Week 24|DCE-MRI was used to measure synovial vascular perfusion. The change from baseline in DCE-MRI parameters of synovial vascular perfusion at Week 24 were measured.|Baseline and Week 24|Full analysis set included participants who received at least one dose of study medication. Hence, number analyzed is the number of participants who were evaluated for this outcome measure.|||mL||Standard Deviation|Mean
2581357|NCT02393378|Primary|Change From Baseline in Synovitis, Erosion and Bone Marrow Edema (Osteitis) Score at Week 24|A Magnetic Resonance Imaging (MRI) of Metacarpophalangeal (MCP) and Wrist of the dominant hand was performed at the baseline and at week 24. Change from the Baseline was assessed according to the Outcome Measures in Rheumatoid Arthritis (RA) Clinical Trials RA-MRI scoring (OMERACT RAMRIS) Standard. RAMRIS score is the sum of its core components: Synovitis Score, Edema Score, and Erosion Score. Synovitis is scored from 0 (normal) to 9 (maximum distension of synovial cavity). Edema is scored 0 (normal) to 69 (maximum articular bone involvement). Erosion is scored from 0 (normal) to 230 (maximum erosion of articular bone). Total RAMRIS score=0 (normal), maximum RAMRIS score=308 (severe structural damage). For Synovial Score, Edema Score, Erosion Score, and RAMRIS score, increasing number = increasing severity.|Baseline and Week 24|Full analysis set included participants who received at least one dose of study medication. Here number analyzed is the number of participants who were evaluated for specific sub-score.|||score on a scale||Standard Deviation|Mean
2581358|NCT02393209|Secondary|TAK-117 Plasma Concentrations When Administered 1 Day After Docetaxel in Phase 2||1 day post docetaxel dose|Data was not analyzed as Phase 2 of study was cancelled.||||||
2581359|NCT02393209|Secondary|T1/2: Terminal Phase Elimination Half-life (T1/2) for TAK-117||Cycle 1 Day 1 pre-dose and up to 24 hours post-dose|This analysis was not performed due to lack of data.||||||
2581360|NCT02393209|Secondary|CL/F: Oral Clearance for TAK-117||Cycle 1 Day 1 pre-dose and up to 24 hours post-dose|This analysis was not performed due to lack of data.||||||
2581361|NCT02393209|Secondary|AUC(Last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Phase 1b for TAK-117||Cycle 1 Day 1 pre-dose and up to 24 hours post-dose|This analysis was not performed due to lack of data.||||||
2581362|NCT02393209|Secondary|AUCtau: Area Under the Concentration Time Curve From Time 0 to the Next Dose in Phase 1b for TAK-117||Cycle 1 Day 1 pre-dose and up to 24 hours post-dose|This analysis was not performed due to lack of data.||||||
2581363|NCT02393209|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117||Cycle 1 Day 1 pre-dose and up to 24 hours post-dose|This analysis was not performed due to lack of data.||||||
2581364|NCT02393209|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-117||Cycle 1 Day 1 pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose|This analysis was not performed due to lack of data.||||||
2581365|NCT02393209|Secondary|TAK-117 Plasma Concentration in Phase 1b||Cycle 1 Day 1 pre-dose and 0.5, 1, 2, 4, 6, 8 and 24 hours post-dose|The PK-evaluable population was defined as all participants for whom there are sufficient dosing and TAK-117 concentration-time data to permit non-compartmental PK analysis. Here 'Number Analyzed' are participants analyzed at the specific timepoint.|||ng/mL||Standard Deviation|Mean
2581366|NCT02393209|Secondary|Overall Survival (OS) in Phase 2|Overall survival is defined as the time from the date of randomization to the date of death.|Approximately 12 months in Phase 2|Data was not analyzed as Phase 2 of the study was cancelled.||||||
2581367|NCT02393209|Secondary|Time to Progression in Phase 2|Time to progression is defined as the time from the date of randomization to the date of first documentation of progression of disease. As per RECIST 1.1, PD is defined as 20% increase in the sum of the longest diameter of target lesions for measurable neoplastic disease.|Approximately 12 months in Phase 2|Data was not analyzed as Phase 2 of the study was cancelled.||||||
2581368|NCT02393209|Secondary|Duration of Response in Phase 2|The duration of response is defined as the time from the date of first documentation of a response to the date of first documentation of progression of disease. As per RECIST 1.1, PD is defined as 20% increase in the sum of the longest diameter of target lesions for measurable neoplastic disease.|Approximately 12 months in Phase 2|Data was not analyzed as Phase 2 of the study was cancelled.||||||
2581444|NCT02392351|Secondary|Mean Reduction in Average 24-hour Ambulatory Systolic Blood Pressure at 6 Months|Change (mean reduction) in the average 24-hour ambulatory systolic blood pressure at 6 months compared to baseline|6 Months|Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment.|||mmHg||Standard Deviation|Mean
2581370|NCT02393209|Secondary|Response Rate in Phase 2|Response rate is defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1. According to RECIST: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions.|Approximately 12 months in Phase 2|Data was not analyzed as Phase 2 of the study was cancelled.||||||
2581371|NCT02393209|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Phase 2|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Approximately 12 months in Phase 2|Safety population was defined as all participants who received at least 1 dose of any study drug.||||||
2581372|NCT02393209|Secondary|Number of Participants With Clinically Significant Change in Clinical Laboratory Tests Reported as Adverse Events in Phase 2|The number of participants with any markedly abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout study.|Approximately 12 months in Phase 2|Safety population was defined as all participants who received at least 1 dose of any study drug.||||||
2581373|NCT02393209|Secondary|Number of Participants With Electrocardiogram (ECG) Findings Reported as Adverse Events in Phase 2|Clinically significant changes from baseline in ECGs will be tabulated by time point including any unscheduled measurements.|Approximately 12 months in Phase 2|Data was not analyzed as Phase 2 of study was cancelled.||||||
2581374|NCT02393209|Secondary|Number of Participants With Significant Change in Physical Examination Reported as Adverse Events in Phase 2|Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10).|Approximately 12 months in Phase 2|Data was not analyzed as Phase 2 of study was cancelled.||||||
2581375|NCT02393209|Secondary|Number of Participants With Significant Change in Vital Signs Reported as Adverse Events in Phase 2|Vital signs (blood pressure, pulse rate, and oral temperature) measurements were collected throughout the study.|Approximately 12 months in Phase 2|Data was not analyzed as Phase 2 of study was cancelled.||||||
2581376|NCT02393209|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Phase 1b|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|From first dose of study drug to 30 days after last dose of study drug (Up to Day 223)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
2581377|NCT02393209|Secondary|Number of Participants With Clinically Significant Change in Clinical Laboratory Tests Reported as Adverse Events in Phase 1b|The number of participants with any markedly abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout study.|First dose of study drug through 30 days after the last dose of study drug (Up to Day 223)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
2581378|NCT02393209|Secondary|Number of Participants With Electrocardiogram (ECG) Findings Reported as Adverse Events in Phase 1b|A standard 12-lead ECG was performed.|First dose of study drug through 30 days after the last dose of study drug (Up to Day 223)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
2581379|NCT02393209|Secondary|Number of Participants With Significant Change in Physical Examination Reported as Adverse Events in Phase 1b|Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10).|First dose of study drug through 30 days after the last dose of study drug (Up to Day 223)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
2581380|NCT02393209|Secondary|Number of Participants With Significant Change in Vital Signs Reported as Adverse Events in Phase 1b|Clinically significant change from baseline in vital sign measures will be assessed. Vital sign measurements included measurements of diastolic and systolic blood pressure, heart rate, and temperature.|First dose of study drug through 30 days after the last dose of study drug (Up to Day 223)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
2581381|NCT02393209|Primary|Progression-Free Survival (PFS) in Phase 2|PFS is defined as the time from the date randomization to the date of first documented progressive disease (PD) or death as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. PD is defined as 20% increase in the sum of the longest diameter of target lesions for measurable neoplastic disease.|Approximately 12 months in Phase 2|Data was not analyzed as Phase 2 of the study was cancelled.||||||
2581445|NCT02392351|Secondary|Number of Subjects Utilizing Anti-hypertensive Medications|Number of subjects utilizing anti-hypertensive medications at 3 months.|3 months||||Participants|||Count of Participants
2581382|NCT02393209|Primary|Recommended Phase 2 Dose of TAK-117 in Phase 1b|The recommended phase 2 dose was determined in Phase 1b based on participant dose-limiting toxicities and the maximum tolerated dose.|Cycle 1 (Up to Day 21)|The DLT-evaluable population was defined as all participants who either experienced DLT during Cycle 1 or complete treatment with at least 75% of the planned doses of TAK-117 plus docetaxel and have sufficient follow-up data to allow investigators and sponsor to determine whether DLT occurred.|||mg|||Number
2581383|NCT02393209|Primary|Maximum Tolerated Dose (MTD) of TAK-117 in Combination With Docetaxel 36 mg/m^2 in Phase 1b|The MTD is defined as the dose of TAK-117 in combination with docetaxel 36 mg/m^2 at which 1 of 6 evaluable participants experience DLT. DLT was evaluated according to NCI CTCAE version 4.03 and was defined as any of the following events: 1. Grade 4 neutropenia or thrombocytopenia lasting ≥7 consecutive days; 2. Grade 4 neutropenia with fever and/or infection; 3. Platelet count <10,000/mm^3; 4. ≥Grade 3 thrombocytopenia with bleeding; 5. Any other ≥Grade 4 hematologic toxicity; 6. Any other ≥Grade 3 nonhematologic toxicity, with following exceptions: ≥Grade 3 arthralgia/myalgia, ≥Grade 3 nausea/emesis, ≥Grade 3 diarrhoea, Grade 3 fatigue, Grade 3 Rash, Grade 3 nonhematological toxicity that could be controlled to ≤Grade 1 with appropriate treatment; 7. Inability to administer at least 75% of planned doses; 8. Clinically significant occurrence per investigator that is a safety risk.|Cycle 1 (Up to Day 21)|The DLT-evaluable population was defined as all participants who either experienced DLT during Cycle 1 or complete treatment with at least 75% of the planned doses of TAK-117 plus docetaxel and have sufficient follow-up data to allow investigators and sponsor to determine whether DLT occurred.|||mg|||Number
2581384|NCT02393209|Primary|Number of Participants With Dose-Limiting Toxicity (DLT) in Phase 1b|DLT was evaluated according to National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and was defined as any of the following events: 1. Grade 4 neutropenia or thrombocytopenia lasting ≥7 consecutive days; 2. Grade 4 neutropenia with fever and/or infection; 3. Platelet count <10,000/mm^3; 4. ≥Grade 3 thrombocytopenia with bleeding; 5. Any other ≥Grade 4 hematologic toxicity; 6. Any other ≥Grade 3 nonhematologic toxicity, with following exceptions: ≥Grade 3 arthralgia/myalgia, ≥Grade 3 nausea/emesis, ≥Grade 3 diarrhoea, Grade 3 fatigue, Grade 3 Rash, Grade 3 nonhematological toxicity that could be controlled to ≤Grade 1 with appropriate treatment; 7. Inability to administer at least 75% of planned doses; 8. Clinically significant occurrence per investigator that is a safety risk.|Cycle 1 (Up to Day 21)|The DLT-evaluable population was defined as all participants who either experienced DLT during Cycle 1 or complete treatment with at least 75% of the planned doses of TAK-117 plus docetaxel and have sufficient follow-up data to allow investigators and sponsor to determine whether DLT occurred.|||participants|||Number
2581385|NCT02392806|Secondary|Oxygenation - Oxygen Saturation Via Pulse Oximetry Recorded Hourly|Number of infants that reach 21% inspired oxygen during initial study period of 72 hours plus the crossover period of 24 hours|96 hours||||Participants|||Count of Participants
2581386|NCT02392806|Primary|Number of Participants With Extubation Failure|Bubble CPAP failure (re-intubation or use of non-invasive positive pressure ventilation) within 72 hours following extubation|Within 72 hours of extubation||||Participants|||Count of Participants
2581387|NCT02392767|Other Pre-specified|Change in Prothrombin Time Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase|"Prothrombin Time was assessed at the visit at start of the supplementation phase and the visit at the end of the 4 week supplementation phase. Blood coagulability is expressed in units of Quick value. In this case, the measured prothrombin time is expressed in relation to the coagulation time of a healthy person. The value obtained is the percentage of the standard Quick value. In a person not receiving oral anticoagulation the normal Quick value is between 70 and 100%. The longer the patient's coagulation time, the lower the Quick value"|Intervention period of 4 weeks||||Percentage of the standard Quick value||95% Confidence Interval|Mean
2581388|NCT02392767|Secondary|Glycated Hemoglobin (HbA1c) Determined on the Final Day of the 4 Week Intervention Period.|Glycated hemoglobin (HbA1c) as percentage of total hemoglobin was determined on the final day of the 4 week intervention period.|After intervention period of 4 weeks||||percentage of total hemoglobin||95% Confidence Interval|Mean
2581389|NCT02392767|Secondary|Asymmetric Dimethyl Arginine (ADMA) Level Determined on the Final Day of the 4 Week Intervention Period.|ADMA (asymmetric dimethyl arginine) was determined on the final day of the 4 week intervention period. Samples were analyzed batch wise using an enzymatic test|After intervention period of 4 weeks||||µmol/l||95% Confidence Interval|Mean
2581390|NCT02392767|Secondary|Homocystein Level Determined on the Final Day of the 4 Week Intervention Period.|"Homocystein level in µmol/l was determined on the final day of the 4 week intervention period.~The first supplementation period started at visit one and lasted for 4 weeks. It was followed by a wash out phase of 8 weeks and subsequently by a second supplementation phase of 4 weeks (cross-over design)"|After intervention period of 4 weeks||||μmol/l||95% Confidence Interval|Mean
2581391|NCT02392767|Secondary|Mean of Blood Pressure Measured Daily at the Last 7 Days of the 4 Week Intervention Period.|The mean of daily systolic and diastolic blood pressure measured daily at the last 7 days of the 4 week intervention period. Measurements were performed by subjects at home and were taken on the left arm, after at least 10 minutes of rest, in a sitting position.|Intervention period of 4 weeks||||mmHg||95% Confidence Interval|Mean
2581392|NCT02392767|Primary|"Change in Endothelial Function Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase (Delta lnRHI)"|"Endothelial function was determined with the EndoPAT™ method (non-invasive Peripheral Aterial Tonometry) using a reactive hyperemia procedure. The outcome measure is the change in endothelial function between the visit at start of the supplementation phase and the visit on the final day of the 4 week supplementation phase. The endothelial function is determined as the natural log of the Reactive Hyperemia Index (lnRHI) which is the post-to-pre occlusion peripheral arterial tonometry signal ratio in the occluded side, relative to the same ratio in the control side, corrected for baseline vascular tone of the occluded side.~Normal lnRHI > 0.51, Abnormal lnRHI < 0.51"|Intervention period of 4 weeks||||Delta lnRHI [Index]||95% Confidence Interval|Mean
2581446|NCT02392351|Secondary|Significant New Renal Artery Stenosis|Number of significant new renal artery stenosis events through 6 months.|6 months||||Participants|||Count of Participants
2581447|NCT02392351|Secondary|Vascular Complications|Number of vascular complications through 4 weeks.|4 weeks||||Participants|||Count of Participants
2581393|NCT02392624|Secondary|Retreatment Efficacy: Change From Time of Retreatment to 12 Weeks After Retreatment in UAS7 Among Participants Randomized to Placebo and Who Were Retreated With Open-Label Omalizumab After Randomization|The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change in score indicates improvement.|At start of retreatment (any time between Weeks 24 and Week 48) and 12 weeks after retreatment (up to Week 60)|Analysis was performed on participants in mITT population who were randomized to placebo arm and who were retreated with open-label omalizumab after randomization. Here, ‘Number Analyzed’ signifies number of participants with available data for this outcome at specified time-point.|||units on a scale||Standard Deviation|Mean
2581394|NCT02392624|Secondary|Change From Randomization (Week 24) to Week 48 in UAS7 Among Participants Who Received Total 48 Weeks Treatment With Omalizumab|The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. A negative change in score (Week 48 score minus Week 24 score) indicates improvement.|Week 24 (randomization) and Week 48|Analysis was performed on participants in mITT population who received total 48 weeks of treatment with omalizumab. If UAS7 data was missing, last observation carry forward (LOCF) method was used post-Week 24 for the closest non-missing UAS7 data up to Week 48.|||units on a scale||Standard Deviation|Mean
2581395|NCT02392624|Secondary|Percentage of Participants Who Experienced Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 Greater Than [>] 6, Maintained for At Least 2 Consecutive Weeks)|The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Clinical worsening in CIU was defined as UAS7 >6 for at least 2 consecutive weeks post-randomization between weeks 24 and 48.|From randomization (Week 24) to Week 48|Analysis was performed on mITT population.|||percentage of participants||95% Confidence Interval|Number
2581396|NCT02392624|Secondary|Time to Clinical Worsening in CIU as Assessed by UAS7 (Clinical Worsening: UAS7 >/=12, Maintained for At Least 2 Consecutive Weeks)|The UAS is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals per 24 hours and the intensity of the pruritus. The total UAS score ranges from 0 to 6. UAS7 is the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Time to clinical worsening in CIU was defined as the number of weeks from the first double-blind treatment to the first two-week interval with UAS7 >/=12 for both weeks. If clinical worsening did not occur, time to clinical worsening was censored at the end of the last week for which the UAS7 score was not missing and less than (<) 12, prior to last randomized dose + 4 weeks, or the first open-label transition dose, whichever was earlier. Median time to clinical worsening was estimated using Kaplan-Meier analysis and corresponding 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.|From randomization (Week 24) to Week 48|Analysis was performed on mITT population.|||weeks||95% Confidence Interval|Median
2581397|NCT02392624|Primary|Percentage of Participants Who Experienced Clinical Worsening in CIU as Assessed by Urticaria Activity Score Over 7 Days (UAS7) (Clinical Worsening: UAS7 Greater Than or Equal to [>/=] 12, Maintained for At Least 2 Consecutive Weeks)|Urticaria activity score (UAS) is a composite diary-recorded score with numeric severity ratings (0=none to 3=intense) for the number of wheals (hives) per 24 hours and the intensity of the pruritus (itch). The total UAS score (sum of the wheal and pruritus scores) ranges from 0 to 6. Due to variations in chronic urticaria disease intensity, assessment of disease activity was based on a weekly (7 days) UAS score called UAS7, that is, the sum of the daily average UASs (average of morning and evening scores), ranging from 0 to 42 per week. A higher score indicates worse disease. Clinical worsening in CIU was defined as UAS7 >/=12 for at least 2 consecutive weeks post-randomization between Weeks 24 and 48.|From randomization (Week 24) to Week 48|Modified Intent-to-Treat (mITT) population included all randomized participants who received at least one dose of blinded study drug, and achieved one post-baseline efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
2581398|NCT02392507|Secondary|Immunogenicity: Number of Participants Developing Anti-drug Antibodies to Necitumumab|A participant was considered to have an anti-drug antibody response if anti-drug antibodies (ADA) were detected at any time point.|Predose Cycle 1 Through Short Term Follow Up (Up To 18 Months)|All randomized participants who received at least 1 dose of study drug and had evaluable data for antibodies.|||Participants|||Count of Participants
2581399|NCT02392507|Secondary|PK: Maximum Concentration (Cmax) of Necitumumab, Nab-Paclitaxel, and Carboplatin|The Cmax is the maximum observed serum/plasma concentration of Necitumumab, Nab-Paclitaxel, and Carboplatin.|Cycle 1, 3 and 4: predose and <15minutes (min) post end-of-infusion|All randomized participants who received at least 1 dose of study drug and had evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2581400|NCT02392507|Secondary|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab, Nab-Paclitaxel, and Carboplatin|The Cmin is the minimum observed serum/plasma concentration of Necitumumab, Nab-Paclitaxel, and Carboplatin.|Cycle 3 and cycle 4: predose|All randomized participants who received at least 1 dose of study drug and had evaluable PK data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2581408|NCT02392481|Secondary|Level of Interleukin-6 (IL-6) in Blood at Follow-up Visit 28 Days After Baseline (Visit 2)|Level of Interleukin-6 (IL-6) (pg/mL) in blood at follow-up visit 28 days after baseline (Visit 2) is presented.|follow-up visit 28 days after baseline (Visit 2)|Biomarker Subjects Set (BM) - All subjects, from the OBS [subjects enrolled in the trial, following the receipt of informed consent, and are eligible to enter the observation period], with at least one valid biomarker measurement either from blood or sputum at either visit.|||pg/mL||Standard Deviation|Mean
2581448|NCT02392351|Secondary|Renal Artery Dissection or Perforation Requiring Intervention|Number of renal artery dissection or perforation requiring intervention through 4 weeks.|4 weeks||||Participants|||Count of Participants
2581401|NCT02392507|Secondary|Percentage of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])|Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.|From Date of Randomization to Objective Disease Progression or Start of New Anticancer Therapy (Up to 18 Months)|All enrolled participants who received at least 1 dose of study drug and who had a complete radiographic assessment at baseline.|||percentage of participants|||Number
2581402|NCT02392507|Secondary|Overall Survival (OS)|OS defined as the time from the date of randomization to the date of death due to any cause. Participants who are alive at the time of study completion or are lost to follow-up will be censored at the time they were last known to be alive.|From Date of Randomization until Death Due to Any Cause (Up to 18 Months)|All randomized participants who received at least 1 dose of study drug. Censored participants = 35.|||Months||95% Confidence Interval|Median
2581403|NCT02392507|Secondary|Progression Free Survival (PFS)|PFS defined as time from date of randomization until first radiographic documentation of measured progressive disease(PD) defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. PD was at least 20% increase in sum of diameters of target lesions with reference being smallest sum on study and an absolute increase of at least 5 mm,or unequivocal progression of non-target lesions,or 1 or more new lesions.If participant does not have complete baseline disease assessment,PFS time censored at date of randomization,regardless of whether or not objectively determined disease progression or death observed for participant.If participant was not known to have died or have objective progression as of data inclusion cutoff date for analysis,the PFS time censored at last adequate tumor assessment date.The use of new anticancer therapy prior to occurrence of PD resulted in censoring at the date of last radiographic assessment prior to initiation of new therapy.|From Date of Randomization to Measured Progressive Disease or Death Due to Any Cause (Up to 18 Months)|All randomized participants who received at least 1 dose of study drug. Censored participants = 15.|||Months||95% Confidence Interval|Median
2581404|NCT02392507|Primary|Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR])|ORR was the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of nontarget lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.|From Date of Randomization to Objective Disease Progression (Up to 18 Months)|All randomized participants who received at least 1 dose of study drug and who had a complete radiographic assessment at baseline and at least 1 complete radiographic assessment post-baseline.|||percentage of participants|||Number
2581405|NCT02392494|Primary|Maximum HCV Viral Load (VL) Change From Baseline Over Time Following Single-Dose MK-1075|For assessment of antiviral activity of MK-1075 at each study dose, baseline and post-dose HCV ribonucleic acid (RNA) (log10) were measured at pre-dose and 2, 4, 8, 12, 16, 24, 32, 48, 72, and 120 hours post-dose. For each participant, baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing. The estimated change from baseline in HCV RNA VL (log10) was calculated for each participant by time point after each single dose, and the maximum change (reduction) in HCV RNA was determined and reported for each treatment arm using an Analysis of Variance (ANOVA) model.|Pre-dose (baseline), 2, 4, 8, 12, 16, 24, 32, 48, 72, and 120 hours post-dose|Per Protocol (PP) Population: all participants who received at least 1 dose of study drug and who complied with the protocol|||log(IU/ml)||Standard Error|Mean
2581406|NCT02392494|Primary|Percentage of Participants Who Discontinued Study Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants that discontinued the study due to an AE was reported for each treatment panel.|Up to Study Day 14|APaT: all participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2581407|NCT02392494|Primary|Percentage of Participants Experiencing an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants that experienced an AE was reported for each treatment panel.|Up to Study Day 14|All Participants as Treated (APaT): all participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2581442|NCT02392351|Secondary|Number of Subjects Utilizing Anti-hypertensive Medications|Number of subjects utilizing anti-hypertensive medications at 6 months|6 months||||Participants|||Count of Participants
2581409|NCT02392481|Secondary|Level of Tumour Necrosis Factor-alpha (TNF-α) in Blood at Follow-up Visit 28 Days After Baseline (Visit 2)|Level of Tumour Necrosis Factor-alpha (TNF-α) (pg/mL) in blood at follow-up visit 28 days after baseline (Visit 2) is presented.|follow-up visit 28 days after baseline (Visit 2)|Biomarker Subjects Set (BM) - All subjects, from the OBS [subjects enrolled in the trial, following the receipt of informed consent, and are eligible to enter the observation period], with at least one valid biomarker measurement either from blood or sputum at either visit.|||pg/mL||Standard Deviation|Mean
2581410|NCT02392481|Primary|Level of Interleukin-6 (IL-6) in Blood at Baseline (Visit 1)|Level of Interleukin-6 (IL-6) (pg/mL) in blood at baseline (Visit 1) is presented.|Baseline (Visit 1)|Biomarker Subjects Set (BM) - All subjects, from the OBS [subjects enrolled in the trial, following the receipt of informed consent, and are eligible to enter the observation period], with at least one valid biomarker measurement either from blood or sputum at either visit.|||pg/mL||Standard Deviation|Mean
2581411|NCT02392481|Primary|Level of Tumour Necrosis Factor-alpha (TNF-α) in Blood at Baseline (Visit 1)|Level of Tumour Necrosis Factor-alpha (TNF-α) [picograms per milliliter (pg/mL)] in blood at baseline (Visit 1) is presented.|Baseline (Visit 1)|Biomarker Subjects Set (BM) - All subjects, from the OBS [subjects enrolled in the trial, following the receipt of informed consent, and are eligible to enter the observation period], with at least one valid biomarker measurement either from blood or sputum at either visit.|||pg/mL||Standard Deviation|Mean
2581412|NCT02392403|Secondary|Number of Adverse Events Post Surgery to 6 Months Post-activation||post surgery to 6 months post-activation||||adverse events|||Number
2581413|NCT02392403|Secondary|Number of Adverse Events at Surgery||at time of surgery||||adverse events|||Number
2581414|NCT02392403|Secondary|Change From Baseline in Air-conduction Pure-tone Hearing Thresholds Via an Audiogram at 6 Months|We report only the change for the 500 Hz frequency.|baseline and 6 months post activation|Note that some patients had no measurable pre-operative hearing|||Decibels||Inter-Quartile Range|Median
2581415|NCT02392403|Secondary|Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months|Rating scale. 0=worst; 10=best|baseline and 6 months post activation||||units on a scale||95% Confidence Interval|Mean
2581416|NCT02392403|Secondary|Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire|"The Glasgow Benefit Inventory is a single time point measure of patient reported benefit.~A score of 0 indicates no benefit; the minimum score is -100 and the maximum is +100."|6 months post activation||||units on a scale||95% Confidence Interval|Mean
2581417|NCT02392403|Secondary|Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months|Change in percent correct speech recognition test scores for implant ear alone and best aided|baseline and 6 months post activation||||Percent correct||Inter-Quartile Range|Median
2581418|NCT02392403|Secondary|Surgeon Questionnaire on Implant Surgery|"To collect experiences using the CI532. At each surgery, the surgeon was asked whether overall the CI532 was easy to handle and the EA32 easy to insert. We counted the number of surgeons who strongly agreed or who agreed."|at time of surgery||||Surgeons|||Number
2581419|NCT02392403|Secondary|Array Proximity to the Modiolus Measured Using the Wrapping Factor|The ratio of the active array length and the corresponding lateral wall length|up to one month post-surgery||||ratio||Standard Deviation|Mean
2581420|NCT02392403|Primary|Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan|The position of the electrode array can be completely in scala tympani, completely in scala vestibuli, or may transverse from scala tympani to scala vestibuli. The position can be determined from high resolution flat panel volume tomography (Cone beam) imaging.|up to one month post-surgery|One patient was explanted and reimplanted with a different type of device.|||Participants|||Count of Participants
2581421|NCT02392377|Secondary|Occurrence of Grade 3 or 4 Toxicity Per the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.0|Toxicities will be summarized as the percentage of patients experiencing each type and grade of event according to treatment group. Patients who receive at least one dose of treatment will be included in the analysis.|Up to 30 days after the end of treatment|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
2581422|NCT02392377|Secondary|Relative Expression Differences Between Baseline and Post-induction microRNA Levels/Profiles Between Patients Achieving and Not Achieving a Pathologic Complete Response Following Treatment|Changes in baseline and post-treatment microRNA level/profiles will be compared between 8 pathologic responders vs. 17 patients not achieving a pathologic complete response per treatment regimen, filtering for expression levels changes of 0.20 and above. Differences in expression level changes per treatment regimen will be calculated using a t-test. Top microRNAs will be tested in combination for their sensitivity and specificity using logistic regression models to predict achievement of a pathologic complete response vs. patients not achieving a pathologic complete response.|Baseline to post-induction (36-43 days)|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
2581423|NCT02392377|Secondary|Relative Expression Differences Between Baseline and Post-induction Gene Expression Levels/Profiles Between Patients Achieving and Not Achieving a Pathologic Complete Response Following Treatment|Changes in baseline and post-treatment gene expression level/profiles will be compared between 8 pathologic responders vs. 17 patients not achieving a pathologic complete response per treatment regimen, filtering for expression levels changes of 0.20 and above. Differences in expression level changes per treatment regimen will be calculated using a t-test. Top genes will be tested in combination for their sensitivity and specificity using logistic regression models to predict achievement of a pathologic complete response vs. patients not achieving a pathologic complete response.|Baseline to post-induction (36-43 days)|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
2581424|NCT02392377|Secondary|Relative Expression Differences in Baseline Individual microRNAs and microRNA Profiles Between Patients Achieving and Not Achieving a Pathologic Complete Response Following Treatment|Baseline microRNA profiles for 8 pathologic complete responders vs. 17 patients not achieving a pathologic complete response per treatment regimen using a t-test will be compared. Top microRNAs will be tested in combination for their sensitivity and specificity using logistic regression models to predict achievement of a pathologic complete response vs. patients not achieving a pathologic complete response.|Baseline|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
2581425|NCT02392377|Secondary|Relative Expression Differences in Baseline Individual Genes and Gene Expression Profiles Between Patients Achieving and Not Achieving a Pathologic Complete Response Following Treatment|Baseline gene expression profiles for 8 pathologic complete responders vs. 17 patients not achieving a pathologic complete response per treatment regimen using a t-test will be compared. Top genes will be tested in combination for their sensitivity and specificity using logistic regression models to predict achievement of a pathologic complete response vs. patients not achieving a pathologic complete response.|Baseline|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
2581426|NCT02392377|Secondary|Relative Expression Differences Between Baseline and Post-induction Chemotherapy Specimens of Individual microRNAs and microRNA Profiles|Changes in baseline and post-treatment microRNA levels will be calculated between (18F) FDG-PET responders and non-responders, filtering for expression level changes of >= 0.20. Differences in expression level change per treatment regimen will be calculated using a t-test and p-values will be corrected for multiple comparisons by calculating FDR p-value (filtering on a FDR p-value < 0.05). Top microRNAs identified will be tested in combination for their sensitivity and specificity using logistic regression models to predict responsiveness or resistance to each individual treatment regimen.|Baseline to post-induction (36-43 days)|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
2581427|NCT02392377|Secondary|Relative Expression Differences Between Baseline and Post-induction Chemotherapy Specimens of Individual Genes and Gene Expression Profiles|Changes in baseline and post-treatment gene expression levels will be calculated between (18F) FDG-PET responders and non-responders, filtering for expression level changes of >= 0.20. Differences in expression level change per treatment regimen will be calculated using a t-test and p-values will be corrected for multiple comparisons by calculating FDR p-value (filtering on a FDR p-value < 0.05). Top genes identified will be tested in combination for their sensitivity and specificity using logistic regression models to predict responsiveness or resistance to each individual treatment regimen.|Baseline to post-induction (36-43 days)|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
2581428|NCT02392377|Primary|Biological Pathway Perturbation Upon Exposure to Chemotherapy|Predefined signatures of biological pathway activities will be evaluated in order to identify pathway perturbation upon exposure to chemotherapy. Significant pathway modulations upon brief exposure will then be evaluated for association with clinical response using non-parametric tests such as the Wilcoxon signed-rank test. In all cases, statistical correction to account for multiple hypothesis testing will be employed and pathways with a false discovery rate of 10% or lower will be considered as significant.|Up to 6 weeks|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
2581429|NCT02392377|Primary|Relative Expression Differences in Individual microRNAs and microRNA Profiles Between Patients Responding and Not Responding to Treatment, Assessed by (18F) FDG-PET|Baseline microRNA profiles will be compared for 10 (18F) FDG-PET responders vs. 15 (18F) FDG-PET non-responders per treatment regimen using a t-test and p-values will be corrected for multiple comparisons by calculating the FDR p-value (filtering on a FDR p-value < 0.05). Top microRNAs identified will be tested in combination for their sensitivity and specificity using logistic regression models.|Baseline|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
2581430|NCT02392377|Primary|Relative Expression Differences in Individual Genes and Gene Profiles Between Patients Responding and Not Responding to Treatment, as Assessed by (18F) FDG-PET|Baseline gene profiles will be compared for 10 (18F) FDG-PET responders vs. 15 (18F) FDG-PET non-responders per treatment regimen using a t-test and p-values will be corrected for multiple comparisons by calculating the false discovery rate (FDR) p-value (filtering on a FDR p-value < 0.05). Top genes identified will be tested in combination for their sensitivity and specificity using logistic regression models.|Baseline|No patients completed study and no patients were enrolled on the comparison group arm. No analysis could be completed.||||||
2581431|NCT02392351|Secondary|Stroke|Number of subjects experiencing stroke through 24 months|24 Months||||Participants|||Count of Participants
2581432|NCT02392351|Secondary|Myocardial Infarction|Number of subjects who experience myocardial infarction through 24 months|24 Months||||Participants|||Count of Participants
2581433|NCT02392351|Secondary|Congestive Heart Failure|Number of subjects with congestive heart failure through 24 months|24 Months||||Participants|||Count of Participants
2581434|NCT02392351|Secondary|Percent of Subjects at Target Blood Pressure|Percent of subjects at target blood pressure through 24 months|24 Months|Number analyzed is based upon participants with a completed Office-Based Systolic Blood Pressure assessment.|||Participants|||Count of Participants
2581435|NCT02392351|Secondary|Mean Reduction in Average Office-based Diastolic Blood Pressure|Mean Reduction in Office-based diastolic blood pressure through 24 months|24 Months|Number analyzed is based upon participants with a completed Office-Based Systolic Blood Pressure assessment.|||mmHg||Standard Deviation|Mean
2581436|NCT02392351|Secondary|Mean Reduction in Average Office-based Systolic Blood Pressure|Mean Reduction in Average office-based systolic blood pressure through 24 months|24 Months|Number analyzed is based upon participants with a completed Office-Based Systolic Blood Pressure assessment.|||mmHg||Standard Deviation|Mean
2581437|NCT02392351|Secondary|Number of Participants With Hypertensive Crisis|Number of hypertensive crisis events through 24 months|24 Months||||Participants|||Count of Participants
2581438|NCT02392351|Secondary|Number of Participants With Renal Failure|Number of renal failure events through 24 months|24 Months||||Participants|||Count of Participants
2581439|NCT02392351|Secondary|All-Cause Death|Number of all causes of death through 24 months|24 Months||||Participants|||Count of Participants
2581440|NCT02392351|Secondary|Mean Reduction in Average 24-hour Ambulatory Diastolic Blood Pressure|Mean reduction in average 24-hour ambulatory diastolic blood pressure at 12 months|12 Months|Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment.|||mmHg||Standard Deviation|Mean
2581441|NCT02392351|Secondary|Mean Reduction in Average 24-Hour Ambulatory Systolic Blood Pressure|Mean Reduction in Average 24-Hour Ambulatory systolic blood pressure at 12 months|12 Months|Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment.|||mmHg||Standard Deviation|Mean
2581451|NCT02392351|Primary|OBSERVATIONAL: Change (Mean Reduction) in Average 24-hour Ambulatory Systolic Blood Pressure (ASBP) Through 8 Weeks|Change (mean reduction) in average 24-hour Ambulatory Systolic Blood Pressure (ASBP) through 8 weeks post randomization in subjects treated with renal denervation (Test) and subjects treated with masked procedure (Control)|Through 8 weeks|Number analyzed is based upon participants with a complete, valid Ambulatory Blood Pressure assessment.|||mmHg||Standard Deviation|Mean
2581452|NCT02392286|Secondary|Number of Participants With Corticosteroid-associated Side Effects|Number of participants with side effects that may be associated with use of corticosteroids such as mood swings, sleep disturbance, edema, acne, bruising, myalgias.|12 weeks|1 patient in fixed dose did not return and did not have any assessment for this outcome after randomization.|||Participants|||Count of Participants
2581453|NCT02392286|Secondary|Number of Participants With Response or Remission at End of 12 Weeks|Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 12 weeks|12 weeks|1 patient in fixed-dose group did not return for this assessment.|||Participants|||Count of Participants
2581454|NCT02392286|Secondary|Number of Participants With Response or Remission at End of 4 Weeks|Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 4 weeks|4 weeks|2 patients in weight-based group and 1 patient in fixed-dose group did not return for this assessment.|||Participants|||Count of Participants
2581455|NCT02392286|Secondary|Number of Participants With Response or Remission at End of 1 Week|Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 1 week|1 week|1 patient in weight-based group and 2 patients in fixed-dose group did not return for this assessment.|||Participants|||Count of Participants
2581456|NCT02392286|Secondary|Number of Participants With Response at End of 2 Weeks|Number of participants with at least a 3-point drop in Harvey-Bradshaw Index at end of 2 weeks|2 weeks|1 patient in fixed-dose group did not return for this assessment.|||Participants|||Count of Participants
2581457|NCT02392286|Primary|Number of Participants in Remission at End of 2 Weeks|Number of participants with Harvey Bradshaw Index < 5 at end of 2 weeks|2 weeks|1 patient in fixed dose group did not return for this assessment.|||Participants|||Count of Participants
2581458|NCT02392247|Primary|Clot Stiffness|Coagulation Function assessed at 4 time points (baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU) over the course of cardiac surgery and bypass until patient ICU transfer|1 day|Matched paired blood samples evaluating coagulation function by two methods (TEG, SEER) for each patient at each of 4 time points [baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU]|||hPa|Participants|Standard Deviation|Mean
2581459|NCT02392247|Primary|Clot Time|Coagulation Function assessed at 4 time points [baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU] over the course of cardiac surgery until patient ICU transfer|1 day|Matched paired blood samples evaluating coagulation function by two methods (TEG, SEER) obtained from each patient at each sampling time (baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU)|||min|Participants|Standard Deviation|Mean
2581460|NCT02392234|Secondary|Ctrough of IVA and IVA Metabolite (M1 IVA) After Administration of IVA Monotherapy||Pre-morning dose on Week 8 of each treatment period|PK set was used. Here ‘Overall Number of participants analyzed’ signifies those participants who had evaluable data for this outcome measure.|||ng/mL||Standard Deviation|Mean
2581461|NCT02392234|Secondary|Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolites (M1 VX-661), IVA and IVA Metabolite (M1 IVA) After Administration of VX-661/IVA Combination Therapy||Pre-morning dose on Week 8 of each treatment period|Pharmacokinetic (PK) set included all randomized participants who received any amount of study drug and had a PK assessment.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2581462|NCT02392234|Secondary|Absolute Change From Study Baseline in Sweat Chloride at Average of Week 4 and Week 8||Baseline, Week 4 and Week 8 of each treatment period|FAS was used. Here 'Overall Number of participants analyzed' signifies those participants who had evaluable data for this outcome measure.|||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2581463|NCT02392234|Secondary|Relative Change From Study Baseline in ppFEV1 at Average of Week 4 and Week 8|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Week 4 and Week 8 of each treatment period|FAS was used. Here ‘Overall Number of participants analyzed’ signifies those participants who had evaluable data for this outcome measure.|||percent change||95% Confidence Interval|Least Squares Mean
2581464|NCT02392234|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)||Day 1 up to Week 28|Safety Set included all participants who received at least 1 dose of study drug.|||participants|||Number
2581465|NCT02392234|Secondary|Absolute Change From Study Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Average of Week 4 and Week 8|The CFQ-R assessed respiratory symptoms on a scale with scores ranging from 0 to 100; where higher scores indicated fewer symptoms and better health-related quality of life.|Baseline, Week 4 and Week 8 of each treatment period|FAS was used. Here 'Overall Number of participants analyzed' signifies those participants who had evaluable data for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2581466|NCT02392234|Primary|Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Week 4 and Week 8 of each treatment period|Full Analysis Set (FAS) included all randomized participants who carry the protocol specified cystic fibrosis transmembrane conductance regulator gene (CFTR) mutations and had received at least 1 dose of study drug. Here ‘Overall Number of participants analyzed’ signifies those participants who had evaluable data for this outcome measure.|||percentage of predicted FEV1||95% Confidence Interval|Least Squares Mean
2581467|NCT02392208|Secondary|AUC24-48 of Telavancin|Area under the telavancin concentration-time curve 24-48 hours from start of infusion|At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48||||mcg*h/mL||Standard Deviation|Mean
2581469|NCT02392208|Primary|t1/2 of Telavancin|Half-life of telavancin|At hours post dose: 0, 1, 1.5, 3, 6.5, 8, 24, 48||||hours||Standard Deviation|Mean
2581473|NCT02392104|Other Pre-specified|Frequency and Type of Protocol Deviations From Both Participants and Study Staff|This outcome determines the frequency and type of protocol deviations from both participants and study staff|Up to 2.25 years|634 eligible participant visits|||percentage of visits|participant visits||Number
2581474|NCT02392104|Secondary|Patient Satisfaction Through Total DASS Score|"Patient satisfaction through total DASS score. DASS = Duke Anticoagulation Satisfaction Scale. 25-item scale.Higher numbers indicate worsening satisfaction ranging from 25-175. Seven-point ordinal scale (not at all = 1, very much = 7)."|baseline, 6 months, 12 months, 24 months||||score on a scale||Standard Deviation|Mean
2581475|NCT02392104|Secondary|Change in Time in Therapeutic Range From Baseline|The outcome will evaluate the change in time in therapeutic range (TTR) from baseline (intention-to-treat)|6, 12, and 24 months|49 participants at 12 months, 44 participants at 24 months|||change in percentage of TTR||Standard Deviation|Mean
2581476|NCT02392104|Secondary|Bleeding and Thromboembolic Events From Baseline|This outcome will determine the number of bleeding and thromboembolic events from baseline|24 months||||events|||Number
2581477|NCT02392104|Secondary|Change in Frequency of Appointments From Baseline to End of Study|This outcome will evaluate the change in frequency of appointments from baseline to end of study (at 12 and 24 months)|12 and 24 months|44 participants remained in the study at 12 months|||visits per 12 months||Standard Deviation|Mean
2581478|NCT02392104|Primary|Number of Participants Scheduled for at Least 4 Consecutive 12-week Intervals|The outcome will determine the number of participants scheduled for at least 4 consecutive 12-week intervals|24 months||||Participants|||Count of Participants
2581479|NCT02392104|Primary|Number of Participants Able to be Scheduled for at Least One 12-week Interval|This outcome will determine the number of participants able to be scheduled for at least one 12-week interval|24 months||||Participants|||Count of Participants
2581480|NCT02392104|Primary|Rates of Participant Accrual|Number of participants who enroll vs. number of individuals invited|up to 2.25 years|107 invited to participate in the study, not all enrolled or started the study|||Participants|||Count of Participants
2581481|NCT02392000|Secondary|Functional Outcomes of Sleep Score|Validated self-report short-form (10 item) measure of Functional Outcomes of Sleep-10 (FOSQ-10). The minimum FOSQ score is 5, the maximum score is 20, and higher scores indicate better functioning. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation).|Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)|Those who completed enrollment and were not withdrawn by study personnel for insomnia are considered those who are counted at Week 0.|||units on a scale||Standard Deviation|Mean
2581482|NCT02392000|Secondary|Pittsburgh Sleep Quality Index (PSQI) Total Score|Validated self-report measure of self-reported sleep quality. The minimum PSQI Total scale score is 0, the maximum scale score is 21 and higher scale scores indicate worse subjective sleep quality. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation).|Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)|Those who completed enrollment and were not withdrawn by study personnel for insomnia are considered those who are counted at Week 0.|||units on a scale||Standard Deviation|Mean
2581483|NCT02392000|Secondary|Insomnia Severity Index Score|Validated self-report measure of Insomnia Symptom Severity (ISI). The minimum ISI scale score is 0, the maximum scale score is 28, and higher scores indicate worse insomnia. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data in the form of means (and standard deviation).|Week 0 (Pre-Intervention) and Week 4 (Mid-Intervention) and Week 6 (Post-Intervention)|Those who completed enrollment and were not withdrawn by study personnel for insomnia are considered those who are counted at Week 0.|||units on a scale||Standard Deviation|Mean
2581484|NCT02392000|Primary|Number of Participants Using CBT-I Coach|CBT = Cognitive Behavioral Therapy. Use of CBT-I Coach sleep diaries in Week 0 and Week 6. We measured participant adherence by a count of the number of participants who used the CBT-I Coach at Week 0 (by our definition of use), and the number of participants using the CBT-I Coach at Week 6. Because of the small number of completers and because this is a feasibility study, we provide only descriptive data.|Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)|Those completing enrollment and not withdrawn by study personnel for insomnia were counted at Week 0. The Week 0 outcome measure is the number of participants who used sleep diaries in the CBT-I Coach for 5 or more nights of Week 0. In Week 6 it is the number of participants who used the CBT-I Coach for 5 or more nights during the sixth week.|||Participants|||Count of Participants
2581485|NCT02392000|Primary|Number of Participants Using WatchPAT|Use of WatchPAT on 3 nights. In Week 0 it is the number of participants who used the WatchPAT that Week (and participants had two possible nights during that week that they could use the WatchPAT). In Week 6 it is the number of participants who used the WatchPAT that Week (and participants had one night that they could use the WatchPAT). We measured participant adherence using a count of the number of participants who used the WatchPAT at Week 0, and the number of participants using the WatchPAT at Week 6.|Week 0 (Pre-Intervention) and Week 6 (Post-Intervention)|Those who completed enrollment and were not withdrawn by study personnel for insomnia are those whose data are used for Week 0.|||Participants|||Count of Participants
2581486|NCT02391987|Secondary|Mortality|All-cause mortality|60 days||||Participants|||Count of Participants
2581487|NCT02391987|Secondary|Number of Readmissions or Visits|Number of hospital readmissions or emergency room visits (visits without admissions)|60 days||||visits|||Number
2581488|NCT02391987|Primary|Hospital Readmission|Occurrence of all-cause hospital readmissions or death within 60 days|60 days||||Participants|||Count of Participants
2581513|NCT02391701|Secondary|Change From Baseline in Body Mass Index (BMI)|BMI will be calculated as body weight (kg) divided by height (m) squared. The BMI of subjects under 18 years of age will be standardised using World Health Organization (WHO) reference data.|Baseline and 6 months|Intent to treat population (all adult participants who were randomized)|||Kg/m2||95% Confidence Interval|Mean
2581514|NCT02391701|Secondary|Change From Baseline in Body Weight|Measurements will be made in triplicate and recorded by standard methods using a SECA 813 digital balance with the subjects in underwear and barefoot. Body weight will be measured to the nearest 0.1 kg.|Baseline and 6 months|Intent to treat population (all participants who were randomized)|||Kg||95% Confidence Interval|Mean
2581489|NCT02391948|Other Pre-specified|Environment Section of the Participation and Environment Measure - Children and Youth (PEM-CY)|"The PEM-CY environment section is a caregiver completed 45-item questionnaire about the facilitators and barriers that might impact the child's participation in the home, school, and community environments. Twenty-five items include ratings on things that help or make it harder for the child to participate in activities in each environment (4-point scale from not an issue to usually makes harder). Twenty items include ratings of the availability of supports for the child's participation in each environment (4-point scale from not needed to usually no). Caregivers can also write in what family members do that help the child participate. A percentage score representing support for participation for each setting is calculated. The higher the percentage the more support the environment provides for the child's participation within the setting."|up to 24-months|Caregiver PEM-CY data was collected on a subset of 79 children who participated in the Physical Activity Measurement Sub-Study. Children did not necessarily start the sub-study at the Baseline visit. Within each time point, there are two rows for age (under 6 years, 6 years and older).|||percentage of support for participation||Standard Deviation|Mean
2581490|NCT02391948|Other Pre-specified|1 Stroke Push Test (1SPT)|The 1SPT is a clinical exercise test, in which the distance rolled in a manual wheelchair, under controlled conditions, with one push using both hands if possible is measured. Within this study a subsample of children who used a manual wheelchair for mobility (GMFCS levels III, IV) were tested on this measure. A surveyor's measure wheel will be used to calculate the total distance (# of feet) wheeled. Standardized directions are used to encourage the child to wheel as far as possible.|up to 24-months|This test was administered for exploratory purposes in the Physical Activity Measurement sub-study. The available N at each time point is 4 or fewer. Also there are two age levels reported at each assessment time and children fell into only one of the two age groups.|||Feet||Standard Deviation|Mean
2581491|NCT02391948|Other Pre-specified|1 Minute to 6 Minute Push Test (1MPT, 6MPT)|The 1MPT to 6MPT are submaximal, clinical exercise tests, in which the total distance propelled in a manual wheelchair in 1-minute and 6-minutes, under controlled conditions, are measured for children who use a manual wheelchair for mobility (GMFCS level II, III, IV), the 1MPT/6MPT was conducted indoors or outdoors on a large, flat, hard terrain. A surveyor's measure wheel was used to calculate the total distance wheeled and a stopwatch to keep track of the allocated time. Standardized directions were used to encourage the child to wheel as far as possible. Distances wheeled (# of feet) are reported for a small number of participants within the Physical Activity sub-study.|up to 24-months|The 1MPT and 6MPT were administered for exploratory purposes in the Physical Activity Measurement sub-study. The available N at each time point = 5 children or fewer. Not every child was tested at every time point.|||Feet||Standard Deviation|Mean
2581492|NCT02391948|Other Pre-specified|Physical Activity Measurement: Actigraph: Average Physical Activity|Participants wore a 3-dimensional accelerometer (Actigraph wGT3X) on their dominant wrist for a seven-day sample. Specific variables reported are average physical activity in raw activity counts per minute for a seven-day sample. The wrist mounted Actigraph counts were converted to waist worn activity counts.|up to 24-months|Actigraph data was collected on a subset of 79 children who participated in the Physical Activity Measurement Sub-Study. Children did not necessarily start the sub-study at the Baseline visit. Within each time point, there are two rows for age (under 6 years, 6 years and older).|||counts per minute||Standard Deviation|Mean
2581493|NCT02391948|Other Pre-specified|Physical Activity Measurement: Actigraph: Minutes of Moderate to Vigorous Physical Activity|Participants wore a 3-dimensional accelerometer (Actigraph wGT3X) on their dominant wrist for a seven-day sample. Specific variables reported are number of minutes time spent in moderate/vigorous physical activity for a seven-day sample. The wrist mounted Actigraph counts were converted to waist worn activity counts.|up to 24-months|Actigraph data was collected on a subset of 79 children who participated in the Physical Activity Measurement Sub-Study. Children did not necessarily start the sub-study at the Baseline visit. Within each time point, there are two rows for age (under 6 years, 6 years and older).|||minutes per day||Standard Deviation|Mean
2581494|NCT02391948|Other Pre-specified|Physical Activity Measurement: StepWatch - Average Number of Single Leg Strides Per Day|For participants who were ambulatory (GMFCS levels I, II, III), walking activity performance was measured within the context of daily life with a monitor called the StepWatch. It is a small (70 x 50 x 20 mm; 38 g), waterproof, self-contained device that is worn on the left ankle. Participants wore the StepWatch on their ankle (inside a knit cuff) each day for a seven-day sample. Specific variables reported are an an amount measure, average number of single leg strides per day for the seven-day sample.|up to 24-months|StepWatch data was collected on a subset of 50 children in GMFCS Level I, II or II who participated in the Physical Activity Measurement Sub-Study. Children did not necessarily start the sub-study at the Baseline visit. Within each time point, there are two rows for age (under 6 years, 6 years and older).|||Avg number single leg strides per day||Standard Deviation|Mean
2581495|NCT02391948|Other Pre-specified|Physical Activity Measurement: StepWatch: Average Number of Strides Per Day Faster Than 30 Per Minute (Moderate- to High-intensity Strides)|For participants who were ambulatory (GMFCS levels I, II, III), walking activity performance was measured within the context of daily life with a monitor called the StepWatch. It is a small (70 x 50 x 20 mm; 38 g), waterproof, self-contained device that is worn on the left ankle. Participants wore the StepWatch on their ankle (inside a knit cuff) each day for a seven-day sample. Specific variables reported are an intensity measure, average number of strides per day faster than 30 per minute (moderate to high intensity strides) for the seven-day sample.|up to 24-months|StepWatch data was collected on a subset of 50 children in GMFCS Level I, II or II who participated in the Physical Activity Measurement Sub-Study. Children did not necessarily start the sub-study at the Baseline visit. Within each time point, there are two rows for age (under 6 years, 6 years and older).|||Strides per day faster than 30 /minute||Standard Deviation|Mean
2581515|NCT02391701|Primary|Changes in Total-cholesterol Levels|"Change from baseline in total cholesterol:~Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics) [Time Frame: 6 months ]"|baseline and 6 months|Intent to treat population (all participants who were randomized)|||mg/dl||95% Confidence Interval|Mean
2581532|NCT02391363|Secondary|Psychological Service Use at 6 Months|Number of participants who discussed personal or emotional problems with a medical provider, clergy, mental health provider, or support group over the past 3 months|Baseline, 6 months|134 participants who completed baseline assessment.|||Participants|||Count of Participants
2581496|NCT02391948|Secondary|Communication Function Classification System (CFCS)|The CFCS is a classification system based on functional communication ability. CFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions for each level are: I: Effective sender/receiver with familiar/unfamiliar partners; II: Effective but slower paced sender and/or receiver with familiar/unfamiliar partners; III: Effective sender & receiver with familiar partners; IV: Inconsistent sender and/or receiver with familiar partners; and V: Seldom effective sender & receiver with familiar partners.|Baseline consensus classification used for children 2 years and over at Baseline and 12M consensus classification used for children under 2 years at Baseline)|Baseline consensus classification used for children 2 years and over at Baseline and 12M consensus classification used for children under 2 years at Baseline)|||participants|||Number
2581497|NCT02391948|Secondary|Manual Ability Classification System (MACS)|The MACS is a classification system based on functional hand movement ability. MACS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions for each level are: I: Handles objects easily & effectively; II: Handles most objects with somewhat reduced quality and/or speed; III: Handles objects with difficulty, needs help to prepare and/or modify activities; IV: Handles a limited selection of easily managed objects; and V: Does not handle objects and has severely limited ability to perform even simple actions.|Baseline consensus classification used for children 2 years and over at Baseline and 12M consensus classification used for children under 2 years at Baseline)|Baseline consensus classification used for children 2 years and over at Baseline and 12M consensus classification used for children under 2 years at Baseline)|||participants|||Number
2581498|NCT02391948|Secondary|Percentage of All Participants According to Gross Motor Function Classification System (GMFCS)|The GMFCS is classification system based on functional body movement ability. GMFCS levels vary from I to V, with a level closest to I reflecting higher function. The general descriptions of a child at 6 to 12 years of age are: I: Walks without limitations; II: Walks with limitations; III: Walks using a hand-held mobility device; IV: Self-mobility with limitations; may use powered mobility; and V: Transported in manual wheelchair. Descriptors for the five levels vary by age of the child. Children were classified by consensus between parents and assessing therapists by comparing the child's functional movement ability to descriptors for each level of classification.|Baseline||||percentage of participants|||Number
2581499|NCT02391948|Primary|Services Questionnaire|The Services questionnaire is a caregiver-completed measure of the medical and rehabilitation services provided to the child in the period since the last data collection point. The variables used for the analysis of the relationship between services and four outcomes are reported. These data are: mean amount of physical, occupational, and speech and language therapy service sessions per year (recorded in 5 ordinal intensity times/year categories: 1=0-1, 2=2-30, 3=31-52, 4=53-155, 5=>156), mean family centeredness across 14 items (scored in 5 ordinal categories: 1=not at all, 2=small, 3=moderate, 4=great, 5=very great extent), mean rating of parents' perceptions that services were meeting their children's needs (scored on ordinal scale 1=not at all, 2=small, 3=moderate, 4=great extent, 5=completely), mean rating of the extent to which therapy was focused into 8 categories (scored in same ordinal categories as family centeredness above). Higher scores indicate a great amount or extent.|up to 24-months|The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow.|||units on a scale||Standard Deviation|Mean
2581500|NCT02391948|Primary|Child Engagement in Daily Life Measure (CEDL): Part 2 - Self-Care|CEDL is a 40-item caregiver-completed questionnaire to estimate children's participation. Part 2 measures self-care, defined as the degree that the child participates in daily feeding, dressing, bathing, and toileting. Part 2 is scored on a 5-point Likert scale from 1= 'does not do the activity' to 5= 'does the activity independently most of the time'. The scale distinguishes the need for physical assistance from a person, the ability to complete the activity under various conditions, and the amount of the activity able to complete. A Rasch analysis has converted scores into 0-100 scaled scores for both parts. A higher score represents a higher degree of self-care (Part 2) participation.|up to 24-months|The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).|||units on a scale||Standard Deviation|Mean
2581501|NCT02391948|Primary|Child Engagement in Daily Life Measure (CEDL): Part 1 - Participation|CEDL is a 40-item caregiver-completed questionnaire to estimate children's participation. Part 1 captures participation of the child in family/community and leisure/recreational activities. Part 1 is scored on two 5-point Likert scales: 1) how often a child participates (1=almost never to 4=very often), and 2) the degree of enjoyment (1=not at all to 5 a great deal). A Rasch analysis has converted scores into 0-100 scaled scores. A higher score represents a higher degree of 'leisure.'|up to 24-months|The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).|||units on a scale||Standard Deviation|Mean
2581502|NCT02391948|Primary|Child Health Conditions Questionnaire|"The Child Health Conditions questionnaire is a caregiver-completed measure of the extent to which health problems influence children's activities. Parents respond yes or no as to whether the child has each of the 16 health problems listed. If the child does not have a problem, a score of 0 is imputed for the next part of the question. If the child has a problem, parents are asked to judge the extent to which the problem affects the child's daily activities. This is measured using an 8-point ordinal scale from 0=does not have the problem, 1= not at all to 7 = to a very great extent. Scores reported are the Child Health Conditions Impact average scores calculated by averaging across all 16 items. Scores range form 0 to 7. A higher score represents a greater impact of health conditions on daily activities."|up to 24-months|The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).|||units on a scale||Standard Deviation|Mean
2581531|NCT02391363|Secondary|Psychological Service Use at 9 Months|Number of participants who discussed personal or emotional problems with a medical provider, clergy, mental health provider, or support group over the past 3 months|Baseline, 9 months|134 participants who completed baseline assessment.|||Participants|||Count of Participants
2581503|NCT02391948|Primary|Early Activity Scale for Endurance (EASE)|"The EASE includes 4 activity-based items requiring parents to rate their children's levels of energy, the frequency and need for rest, and the average amount of time their children can engage in physical activity. Scoring for each item is on a Likert scale of 1-5 with the value of 1 = Never to 5 = Always. The four questions include: 1) my child's physical activity level is similar to other children his or her age, 2) my child has a high physical energy level and rarely needs to take rests when moving himself or herself around during daily activities and play time, 3) my child does enough activity so that he or she is breathing quickly or gets flushing in his or her face at least one time each day, and 4) my child spends a lot of his or her play or free time doing activities that require lots of physical energy. Scores are reported by calculating the average across all 4 questions. Scores range from 1 to 5. A higher score represents better endurance for activity."|up to 24-months|The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).|||units on a scale||Standard Deviation|Mean
2581504|NCT02391948|Primary|Six and One-minute Walk Test (6MWT, 1MWT)|The 6MWT and 1MWT are submaximal, clinical exercise tests, in which the total distance traveled in 1-minute and 6-minutes, under controlled conditions, are measured. Within this study, the 6MWT/1MWT was conducted indoors or outdoors on a large, flat, hard terrain for children who were 3 years or older and who were walking without another person's assistance (GMFCS I, II, III). A surveyor's measure wheel was used to calculate the total distance (# of feet) walked and a stopwatch to keep track of the allocated time. Standardized directions are used to encourage the child to walk as far as possible in the time.|up to 24-months|The available N for 6MWT at 12M (highest #) is represented under Overall # Analyzed. For each time point, there are 2 rows for age. Of the available N at each time point (see Participant Flow), the Walk Test was given only to GMFCS Level I, II, or III age 3yrs+. The 1MWT was given to a smaller subset of children in the Physical Activity Sub-Study.|||Feet||Standard Deviation|Mean
2581505|NCT02391948|Primary|Functional Strength Assessment (FSA)|The FSA addresses force production ability in the neck and trunk flexor and extensor and bilateral hip and knee extensor and shoulder flexor muscle groups. Each muscle group is rated on a five-point ordinal scale from 1 = only flicker of contraction or just initiates movement against gravity to 5 = full available range against gravity and strong resistance. Scores are reported by calculating the average of scores across all 8 items. Scores range from 1 to 5. A higher score represents better force production ability.|up to 24-months|The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).|||units on a scale||Standard Deviation|Mean
2581506|NCT02391948|Primary|Spinal Alignment and Range of Motion Measure (SAROMM)|"The SAROMM addresses joint range of motion, extensibility, and spinal alignment. The Spinal Alignment Subscale contains 4 items and the Range of Motion and Extensibility Subscale has 22 items. Each item is scored on a 5-point Likert scale, with 0 = normal alignment and range with active correction, 1 = normal alignment and range with passive correction, and 2, 3, and 4 indicating fixed deformities or contractures that are mild, moderate, or severe based on pre-specified cut points, and supported by photographs in the training manual. Scores are reported by calculating the average of scores across all 26 items. Scores range from 0-4. A lower score represents better range of motion and alignment."|up to 24-months|The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).|||units on a scale||Standard Deviation|Mean
2581507|NCT02391948|Primary|Early Clinical Assessment of Balance (ECAB)|The ECAB addresses postural control and balance across the developmental sequence. Part I has 7 items (with numbers 1,4,5,6,7 scored bilaterally): 1) lateral head righting, 2) head righting in extension, 3) head righting in flexion, 4) rotation in the trunk, 5) equilibrium reactions in sitting, 6) protective extension to the side, and 7) protective extension backwards. The items are scored on a scale of 0 = no response to 3 = complete & consistent response. Part II has 6 items: 1) sitting with back unsupported but feet supported, 2) moving from sitting to standing, 3) standing unsupported with eyes closed, 4) standing unsupported with feet together, 5) turning 360 degrees in standing unsupported, 6) placing alternate foot on the step while standing unsupported. These items are scored on a variable scale, which is weighted due to the increased difficulty of the items. Part I and Part II item scores are summed for a total score between 0-100. A higher score represents better balance.|up to 24-months|The overall N=708 available at Baseline is represented under Overall Number of Participants Analyzed. Available N at each time point is described under Participant Flow. Within each time point, there are two rows for age (under 6 years, 6 years and older).|||units on a scale||Standard Deviation|Mean
2581508|NCT02391714|Secondary|Baseline Mean Pain Scores|Baseline pain scores prior to IUD insertion is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. The minimal clinically important difference in pain for this study was set at 15mm.|Before the IUD insertion procedure||||units on a scale||Standard Deviation|Mean
2581509|NCT02391714|Secondary|Patient Satisfaction With Over-all Pain Control With IUD Insertion - VAS|Satisfaction will be measured using a 100mm Visual Analog Scale (VAS), with anchors 0mm for very satisfied and 100mm for very dissatisfied.|Prior to clinic discharge, which is an average of 15 minutes after the procedure||||units on a scale||Standard Deviation|Mean
2581510|NCT02391714|Primary|Mean Maximum Procedural Pain Scores|Pain is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. The minimal clinically important difference in pain for this study was set at 15mm.|2 minutes after the procedure.||||units on a scale||Standard Deviation|Mean
2581511|NCT02391701|Secondary|Change From Baseline in Fasting Plasma Glucose|Enzymatic method using standard kits on an Advia 2400 Clinical Chemistry System (Siemens Healthcare Diagnostics)|Baseline and 6 months|Intent to treat population (all participants who were randomized)|||mg/dL||95% Confidence Interval|Mean
2581512|NCT02391701|Secondary|Change From Baseline in Hip/Waist Index|"Waist circumference will be measured at the narrowest point between the bottom rib and the top of the iliac crest using a SECA 201 flexible, non-elastic tape.~Hip circumference will be measured at the point of greatest prominence of the gluteal muscles using a SECA 201 flexible, non-elastic tape."|Baseline and 6 months|Intent to treat population (all participants who were randomized)|||Ratio||95% Confidence Interval|Mean
2581516|NCT02391584|Secondary|Mean Change in Overall ETDQ-7 Score|Mean change from baseline to 6 weeks in the overall ETDQ-7 score. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that your ears are clogged or underwater, ear symptoms when you have a cold of sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that your hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms.|6 weeks postdilation|All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 6-week follow-up.|||units on a scale||Standard Deviation|Least Squares Mean
2581517|NCT02391584|Secondary|Mean Change in Overall ETDQ-7 Score|Mean change from baseline to 3 months in the overall ETDQ-7 score. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that your ears are clogged or underwater, ear symptoms when you have a cold of sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that your hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms.|3 months postdilation|All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 3-month follow-up.|||units on a scale||Standard Deviation|Least Squares Mean
2581518|NCT02391584|Secondary|Mean Change in Overall ETDQ-7 Score|Mean change from baseline to 6 months in the overall ETDQ-7 score. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that your ears are clogged or underwater, ear symptoms when you have a cold of sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that your hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms.|6 months postdilation|All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 6-month follow-up.|||units on a scale||Standard Deviation|Least Squares Mean
2581519|NCT02391584|Secondary|Mean Change in Overall ETDQ-7 Score|Mean change from baseline to 12 months in the overall ETDQ-7 score. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that your ears are clogged or underwater, ear symptoms when you have a cold of sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that your hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms.|12 months postdilation|All balloon dilation participants (randomized and crossover) who completed an ETDQ-7 questionnaire at 12-month follow-up.|||units on a scale||Standard Deviation|Least Squares Mean
2581520|NCT02391584|Secondary|Revision Rate|Percent of participants undergoing repeat balloon dilation procedure on an ET that was initially treated with an XprESS device|12 months|All participants who underwent balloon dilation (randomized and crossover).|||Participants|||Count of Participants
2581521|NCT02391584|Secondary|Technical Success Rate|Percent of successful ET dilations per attempted ET dilations|Immediately after procedure|All participants who underwent an attempted unilateral or bilateral balloon dilation of the ET.|||percentage of successful dilations|ears||Number
2581522|NCT02391584|Primary|Complication Rate|Number of subjects who experience serious device- or procedure-related adverse events|Through 6 months post-procedure|All participant's randomized to balloon dilation who underwent the procedure and all control participant's with 6-week follow-up.|||Participants|||Count of Participants
2581523|NCT02391584|Primary|Change From Baseline in Mean Overall ETDQ-7 Scores|"Comparison of mean change in overall ETDQ-7 scores from baseline to 6 weeks between randomized arms.~The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) is a validated patient-reported tool measuring ETD symptoms and severity. The 7 items are: pressure in the ears, pain in the ears, a feeling that your ears are clogged or underwater, ear symptoms when you have a cold of sinusitis, cracking or popping sounds in the ear, ringing in the ears, and a feeling that your hearing is muffled. Each item is rated from 1 (no problem) to 7 (severe problem) and a mean is calculated for the overall score (range from 1-7). Scores of 1-2 indicate no to mild symptoms, 3-5 moderate, and 6-7 severe symptoms."|6 weeks post procedure (treatment arm) or randomization (control arm)|All randomized participants with completed ETDQ-7 questionnaire at 6-week follow-up|||units on a scale||Standard Deviation|Mean
2581524|NCT02391545|Secondary|Pharmacokinetic (PK): Plasma Concentrations of Duvelisib and IPI-656 (Metabolite)|Plasma concentrations of Duvelisib and IPI-656 (metabolite)|Every 4 weeks for 16 weeks|The study had been terminated and PK analysis was not performed.||||||
2581525|NCT02391545|Secondary|Overall Survival (OS)||Up to 2 years from the first dose of study treatment|The study had been terminated and Overall Survival was not performed.||||||
2581526|NCT02391545|Secondary|Duration of Response (DOR)|The median DOR was non-estimable.|Up to 2 years from the first dose of study treatment|Data could not be reported because the study was terminated early and a sufficient number of subjects and events were not available for analysis.||||||
2581527|NCT02391545|Secondary|Overall Response Rate (ORR)||Up to 2 years from the first dose of study treatment||||participants|||Number
2581528|NCT02391545|Secondary|Safety: Composite Measure of Safety, as Indicated by Treatment-emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values|Composite measure of safety, as indicated by Treatment-emergent adverse events (TEAEs) and changes in safety laboratory values. TEAEs assessed as >=Grade 3.|Up to 30 days after the last dose of study treatment||||Participants|||Count of Participants
2581529|NCT02391545|Primary|Complete Response Rate (CRR)- Part 2||Up to 2 years from the first dose of study treatment||||Participants|||Count of Participants
2581530|NCT02391545|Primary|Number of Subjects With Dose Limiting Toxicities (DLTs) - Part 1||28 days from first dose of study treatment||||Participants|||Count of Participants
2582706|NCT02376166|Secondary|Urgency to Have a Bowel Movement Episodes|Quality of LIfe as measured by a modified RAND 36-Item Health Survey. Ist reported outcome - Number of episodes of urgency to have a bowel movement|6 months||||episodes|||Number
2581537|NCT02391363|Secondary|Health Service Use at 9 Months|Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months.|Baseline, 9 months|134 participants who completed baseline assessment.|||Participants|||Count of Participants
2581538|NCT02391363|Secondary|Health Service Use at 6 Months|Number of participants who had visited a health care provider (e.g., physician, nurse, physician's assistant) over the past 3 months.|Baseline, 6 months|134 participants who completed baseline assessment.|||Participants|||Count of Participants
2581539|NCT02391363|Secondary|PTSD Checklist-5 (PCL-5) Total at 9 Months|Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity.|Baseline, 9 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581540|NCT02391363|Secondary|PTSD Checklist-5 (PCL-5) Total at 6 Months|Measure of PTSD symptoms. 20 items rated from 0 (not at all) to 4 (extremely). Scores range from 0 to 80. Higher scores = higher symptom severity.|Baseline, 6 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581541|NCT02391363|Secondary|Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 9 Months|Mental component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100.Higher scores indicate higher levels of mental health functioning.|Baseline, 9 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581542|NCT02391363|Secondary|Medical Outcomes Study 12-Item Short-Form Survey Mental Component Summary (SF-12 MCS) at 6 Months|Mental component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100.Higher scores indicate higher levels of mental health functioning.|Baseline, 6 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581543|NCT02391363|Secondary|Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS)|Physical component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100. Higher scores indicate higher levels of physical functioning.|Baseline, 9 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581544|NCT02391363|Secondary|Medical Outcomes Study 12-Item Short-Form Health Survey Physical Component Summary (SF-12 PCS) at 6 Months|Physical component summary score of the 12-item Medical Outcomes Study Short Form (SF-12), a measure of health-related quality of life. Summary raw scores are transformed to scale scores ranging from 0 to 100. Higher scores indicate higher levels of physical functioning.|Baseline, 6 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581545|NCT02391363|Secondary|Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation|Measure that assesses disability limitations across 16 life tasks and social roles. Limitations for the 16 items are rated on a scale from 1 (completely limited) to 5 (not at all limited). Raw scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher levels of capability of participating in tasks/higher functioning.|Baseline, 9 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581546|NCT02391363|Secondary|Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Limitation at 6 Months|Measure that assesses disability limitations across 16 life tasks and social roles. Limitations for the 16 items are rated on a scale from 1 (completely limited) to 5 (not at all limited). Raw scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher levels of capability of participating in tasks/higher functioning.|Baseline, 6 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581547|NCT02391363|Secondary|Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 9 Months|Measure that assesses disability frequency across 16 life tasks and social roles. Frequencies for the 16 items are rated on a scale from 1 (never) to 5 (very often). Summary scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher participation in tasks/higher functioning.|Baseline, 9 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581548|NCT02391363|Secondary|Late-Life Function and Disability Instrument (LL-FDI) Disability Subscale - Frequency at 6 Months|Measure that assesses disability frequency across 16 life tasks and social roles. Frequencies for the 16 items are rated on a scale from 1 (never) to 5 (very often). Summary scores are transformed to scaled summary scores ranging from 0 to 100. Higher scores represent higher participation in tasks/higher functioning.|Baseline, 6 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581549|NCT02391363|Secondary|Insomnia Severity Index (ISI) at 9 Months|Measure of sleep difficulties consisting of 7 items rated on a 0-4 scale. Scores range from 0 to 28. Higher scores indicate greater sleep difficulties.|Baseline, 9 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581550|NCT02391363|Secondary|Insomnia Severity Index (ISI) at 6 Months|Measure of sleep difficulties consisting of 7 items rated on a 0-4 scale. Scores range from 0 to 28. Higher scores indicate greater sleep difficulties.|Baseline, 6 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581551|NCT02391363|Secondary|Geriatric Depression Scale Short Form (GDS) at 9 Months|Brief measure of depression designed for use with older adults consisting of 15 items rated yes (1) or no (0). Scores range from 0 to 15. Higher scores indicate greater depression.|Baseline, 9 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581552|NCT02391363|Secondary|Geriatric Depression Scale Short Form (GDS) at 6 Months|Brief measure of depression designed for use with older adults consisting of 15 items rated yes (1) or no (0). Scores range from 0 to 15. Higher scores indicate greater depression.|Baseline, 6 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581638|NCT02390791|Secondary|Parent Distress (Parenting Stress Index - Short Form)|Parental distress subscale score calculated from the Parenting Stress Index - Short Form; range 36-180, higher scores is worse (more stress)|6 months after starting treatment|population who completed this outcome assessment|||score on a scale||Inter-Quartile Range|Median
2581553|NCT02391363|Secondary|Patient Health Questionnaire Depression Scale (PHQ 8) at 9 Months|Brief measure of depression symptoms consisting of 8 items rated from 0-3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Scores range from 0 to 24. Higher scores indicate greater depression severity.|Baseline, 9 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581554|NCT02391363|Secondary|Patient Health Questionnaire Depression Scale (PHQ 8) at 6 Months|Brief measure of depression symptoms consisting of 8 items rated from 0-3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Scores range from 0 to 24. Higher scores indicate greater depression severity.|Baseline, 6 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581555|NCT02391363|Secondary|Geriatric Anxiety Inventory - SF (GAI-SF) at 9 Months|Five item scale with response options of yes = 1 and no = 0 to each item. Scores range from 0 to 5. Greater scores indicate greater anxiety.|Baseline, 9 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581556|NCT02391363|Secondary|Geriatric Anxiety Inventory - SF (GAI-SF) at 6 Months|Five item scale with response options of yes = 1 and no = 0 to each item. Scores range from 0 to 5. Greater scores indicate greater anxiety.|Baseline, 6 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581557|NCT02391363|Primary|Generalized Anxiety Disorder-7 (GAD-7) at 9 Months|Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms.|Baseline, 9 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581558|NCT02391363|Primary|Generalized Anxiety Disorder-7 (GAD-7) at 6 Months|Measure of Generalized Anxiety Disorder symptoms. 7 items rated from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21. Higher scores indicate greater GAD symptoms.|Baseline, 6 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581559|NCT02391363|Primary|Penn State Worry Questionnaire - A (PSWQ-A) at 9 Months|Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety.|Baseline, 9 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581560|NCT02391363|Primary|Penn State Worry Questionnaire - A (PSWQ-A) at 6 Months|Brief measure of worry with 8 items measured on a 1-5 scale (1 = not at all typical, 3 = somewhat typical, 5 = very typical). Scores range from 8 to 40. Higher scores indicate greater anxiety.|Baseline, 6 months|134 participants who completed baseline assessment.|||units on a scale||Standard Deviation|Mean
2581561|NCT02391311|Secondary|Change in Driving Simulator Performance|Driving Simulator Performance: Center lane crossings (a count of how many times an individual crosses the centerline during the entire simulator drive). A difference score was taken between time 2 and time 1 and compared between treatment groups (sham condition and tDCS condition). A negative difference score indicates that fewer center line crossings were made at time 2 than time 1, while positive difference scores indicate the opposite direction, and scores of 0 represent no change.|baseline, 6 week posttest|While n=33 was the final sample used for the primary outcome analyses, n=30 was used for the secondary outcome as 3 subjects did not have available simulator data.|||Times crossing center lane||95% Confidence Interval|Mean
2581562|NCT02391311|Primary|Change in the Processing of Speed|Computerized and paper & pencil processing speed measures were used to evaluate this outcome. The Letter and Pattern Comparison Tasks are traditional paper and pencil (SOP) measures. Specifically, they assess perceptual speed. In Letter Comparison subjects are shown three sets of 32 pairs of letters containing 3, 6, or 9 segments. The participants are instructed to decide whether the patterns between the pairs are the same or different within each set, with a time limit of 20 sec per set. Pattern Comparison also presents three sets of 32 pairs of patterns with 3, 6, or 9 line segments. Similarly, participants are instructed to decide whether the patterns are the same or different within the 20 sec time limit. For each measure, the total score is the number of correct answers from all three sets. Larger scores indicate better reasoning and cognitive functioning. In this study scores from Letter and Pattern Comparison were combined for a total Letter/Pattern Score.|baseline, 6 week posttest|n=33 subjects were included in final analyses. Of the 37 that completed the study, 4 were deemed ineligible after they had completed the study due to confirmation with medical records they had conditions that may affect neurocognition (stroke and schizophrenia) although they self reported on the screen they did not have these conditions.|||units on a scale||Full Range|Mean
2581563|NCT02391116|Other Pre-specified|ORR by DLBCL/COO Subtype Based on Central Imaging Review|The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The overall response assessment for this outcome measure was based on central imaging review.|From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)|Full analysis set (FAS)|||Percentage of participants||90% Confidence Interval|Number
2581564|NCT02391116|Other Pre-specified|ORR by CD79b Status Based on Central Imaging Review|The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The overall response assessment for this outcome measure was based on central imaging review.|From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)|Full analysis set (FAS)|||Percentage of participants||90% Confidence Interval|Number
2581565|NCT02391116|Other Pre-specified|ORR in Total Population Based on Central Imaging Review|The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The overall response assessment for this outcome measure was based on central imaging review.|From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)|Full analysis set|||Percentage of participants||90% Confidence Interval|Number
2581566|NCT02391116|Other Pre-specified|Time to Response (TTR) in Total Population|The time to response (TTR) was defined as the time (days) from start of study treatment to the date of first observed response (first measured CR or PR). TTR was defined for responders only (i.e. participants with CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first|Responders (i.e. participants with a best response of CR or PR) in full analysis set based on the investigator assessment|||Days||95% Confidence Interval|Median
2581567|NCT02391116|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|A TEAE was defined as any event arising or worsening after the start of study drug administration until 30 days after the last application.|From start of test drug to 30 days after the last test drug intake, assessed up to 2 years after the last participant's first treatment or the last participant dies (whichever occurs first), with an average of 15 weeks for individual participant|Safety analysis set (SAF)|||Participants|||Number
2581568|NCT02391116|Secondary|DCR by DLBCL/COO Subtype|The disease control rate (DCR) was defined as the percentage of participants who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first|Full analysis set (FAS)|||Percentage of participants||90% Confidence Interval|Number
2581569|NCT02391116|Secondary|DCR by CD79b Status|The disease control rate (DCR) was defined as the percentage of participants who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first|Full analysis set (FAS)|||Percentage of participants||90% Confidence Interval|Number
2581570|NCT02391116|Secondary|Disease Control Rate (DCR) in Total Population|The disease control rate (DCR) was defined as the percentage of participants who had a best response rating of CR, PR, or SD that was achieved during treatment or within 30 days after termination of study drug. The tumor response was based on investigator assessment according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first|Full analysis set (FAS)|||Percentage of participants||90% Confidence Interval|Number
2581571|NCT02391116|Secondary|Duration of Stable Disease (DOSD) in Total Population|The duration of stable disease (DOSD) was defined as the time (in days) from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier. The DOSD was only evaluated in participants failing to achieve a best response of CR or PR, but who achieved SD (stable disease), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first|Participants who failed to achieve CR or PR but achieved SD in full analysis set based on the investigator assessment|||Days||95% Confidence Interval|Median
2581572|NCT02391116|Secondary|OS by DLBCL/COO Subtype|The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.|From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first|Full analysis set (FAS)|||Days||95% Confidence Interval|Median
2581573|NCT02391116|Secondary|OS by CD79b Status|The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.|From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first|Full analysis set (FAS)|||Days||95% Confidence Interval|Median
2581574|NCT02391116|Secondary|Overall Survival (OS) in Total Population|The overall survival (OS) was defined as the time from date of start of study treatment until death from any cause.|From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first|Full analysis set (FAS)|||Days||95% Confidence Interval|Median
2581575|NCT02391116|Secondary|PFS by DLBCL/COO Subtype|The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first|Full analysis set (FAS)|||Days||95% Confidence Interval|Median
2581576|NCT02391116|Secondary|PFS by CD79b Status|The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first|Full analysis set (FAS)|||Days||95% Confidence Interval|Median
2581577|NCT02391116|Secondary|Progression-free Survival (PFS) in Total Population|The progression-free survival (PFS) was defined as the time from date of start of study treatment to radiological PD or death due to any cause, whichever was earlier, based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first|Full analysis set (FAS)|||Days||95% Confidence Interval|Median
2581639|NCT02390791|Secondary|Parent Perceived Social Support (Perceived Social Support Scale)|Total score calculated from parent-report on the Perceived Social Support Scale, range 12-84, higher score better (more social support)|6 months after starting treatment|population who completed this outcome assessment|||score on a scale||Inter-Quartile Range|Median
2581578|NCT02391116|Secondary|DOR by DLBCL/COO Subtype|The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. participants with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first|Responders (i.e. participants with a best response of CR or PR) in full analysis set based on the investigator assessment|||Days||95% Confidence Interval|Median
2581579|NCT02391116|Secondary|DOR by CD79b Status|The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. participants with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first|Responders (i.e. participants with a best response of CR or PR) in full analysis set based on the investigator assessment|||Days||95% Confidence Interval|Median
2581580|NCT02391116|Secondary|Duration of Response (DOR) in Total Population|The duration of response (DOR) was defined as the time from the date of first observed overall response (CR or PR) until radiological PD or death due to any cause, whichever was earlier. DOR was defined for responders only (i.e. participants with a best response of CR or PR), based on the investigator assessment of tumor response according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT.|From start of study treatment assessed up to 2 years after the last participant's first treatment or the last participant dies, whichever occurs first|Responders (i.e. participants with a best response of CR or PR) in full analysis set based on the investigator assessment|||Days||95% Confidence Interval|Median
2581581|NCT02391116|Primary|ORR by DLBCL/COO Subtype Based on Investigator Assessment|The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.|From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)|Full analysis set (FAS) and per protocol set (PPS)|||Percentage of participants||90% Confidence Interval|Number
2581582|NCT02391116|Primary|ORR by CD79b Status Based on Investigator Assessment|The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.|From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)|Full analysis set (FAS) and per protocol set (PPS)|||Percentage of participants||90% Confidence Interval|Number
2581583|NCT02391116|Primary|Objective Response Rate (ORR) in Total Population Based on Investigator Assessment|The objective response rate (ORR) was defined as the percentage of participants who had at least one post-baseline overall response of complete response (CR) or partial response (PR) during study conduct according to the criteria defined by the Lugano Classification, 2014 and assessed by CT/MRI/PET-CT. The primary efficacy overall response assessment was based on investigator assessment of response.|From start of study treatment assessed up to 24 weeks after the last participant fully evaluable for the primary endpoint started treatment (about 12 months)|Full analysis set (FAS) and per protocol set (PPS)|||Percentage of participants||90% Confidence Interval|Number
2581584|NCT02391038|Secondary|Phase 2- Number of Participants With ATA in Serum|Blood samples were to be collected predose to evaluate ATA.|Baseline up to approximately 1 year|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
2581585|NCT02391038|Secondary|Phase 2- Guanylyl Cyclase C (GCC) H-score Assessed by Immunohistochemistry (IHC)|The H-score is a method of assessing the extent of nuclear immunoreactivity, applicable to steroid receptors. The score is obtained by the formula: 3 * percentage of strongly staining nuclei + 2 * percentage of moderately staining nuclei + percentage of weakly staining nuclei, giving a range of 0 to 300. The 600 H-score is based on the sum of the 0 to 300 H-score for cytoplasmic staining and the 0 to 300 H-score for apical staining|Baseline up to approximately 1 year|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
2581586|NCT02391038|Secondary|Phase 2- Tumor Size Reduction|For each participant, the best percentage of tumor reduction from baseline in the sum of the diameter was calculated.|Baseline up to approximately 1 year|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
2581587|NCT02391038|Secondary|Phase 2- Plasma Concentration of MLN0264||Day 1 of every cycle (up to 1 year): predose and at multiple time points(up to 336 hours) post-dose|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
2581608|NCT02391038|Primary|Phase 1: Cycle 1- Cmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE)||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2581588|NCT02391038|Secondary|Phase 2- Overall Survival (OS)|OS is defined as the time from the date of first study drug administration to the date of death. Participants without documentation of death at the time of analysis were censored at the date when they were last known to be alive.|Baseline up to EOT thereafter every 12 weeks until death or the start of subsequent antineoplastic therapy, or 6 months after discontinuation from treatment, whichever occurs first (total duration of assessment up to 1.5 years)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
2581589|NCT02391038|Secondary|Phase 2- Disease Control Rate (DCR)|DCR is defined as Complete Response (CR) rate + Partial Response (PR) rate + stable disease (SD) rate with a minimum of 12 weeks' duration. Duration of SD is defined as the time from the date of first study drug administration to the date of first documentation of disease progression for participants who achieved SD as the best overall response. CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; PD:at least a 20% increase in the sum of the LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions) and SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Phase 2: Day 21 of every other cycle (Cycle 2, 4, 6, 8) up to EOT (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
2581590|NCT02391038|Secondary|Phase 2- Duration of Response (DOR)|DOR is defined as the time from the date of first documentation of a confirmed response to the date of first documentation of Progressive Disease (PD). Responders without documentation of PD were censored at the last response assessment that was stable disease or better. CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD and PD:at least a 20% increase in the sum of the LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions.|Day 21 of every other cycle (Cycle 2, 4, 6, 8) up to EOT (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
2581591|NCT02391038|Secondary|Phase 2- Progression-free Survival (PFS)|PFS is defined as the time from the date of first study drug administration to the date of first documentation of progressive disease or death. For a participant who has not progressed and is last known to be alive, PFS was censored at the last response assessment that was stable disease or better. PD:at least a 20% increase in the sum of the LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions.|Baseline up to EOT, thereafter every 12 weeks until the occurrence of PD, the start of subsequent antineoplastic therapy, or 6 months after discontinuation from treatment, whichever occurs first (total duration of assessment up to 1.5 years)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
2581592|NCT02391038|Secondary|Phase 2- Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs include body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (beats per minute [bpm]).|Phase 2: Baseline up to 30 days after last dose of study drug (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
2581593|NCT02391038|Secondary|Phase 2- Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Laboratory assessment includes serum chemistry, hematology, urine analysis and coagulation.|Phase 2: Baseline up to 30 days after last dose of study drug (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
2581594|NCT02391038|Secondary|Phase 2- Percentage of Participants Who Experience at Least One SAE||Phase 2: Baseline up to 30 days after last dose of study drug (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
2581595|NCT02391038|Secondary|Phase 2- Percentage of Participants Who Experience at Least One TEAE||Phase 2: Baseline up to 30 days after last dose of study drug (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
2581609|NCT02391038|Primary|Phase 1: Cycle 2- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for TAb||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.|||mcg/mL||Standard Deviation|Geometric Mean
2581640|NCT02390791|Secondary|Working Alliance Inventory|range 12-60, higher scores better (more alliance)|6 months after starting treatment|population who completed this outcome assessment|||score on a scale||Inter-Quartile Range|Median
2601689|NCT02150837|Secondary|Abdominal Circumference|Abdominal circumference expressed as an absolute change from baseline.|20 weeks||||Inches||Standard Deviation|Mean
2581596|NCT02391038|Secondary|Phase 1- Disease Response Based on the Investigator's Assessment|Disease response was based on the investigator's assessment using the modified RECIST version 1.1 guidelines. Evaluation of target lesions included CR (Disappearance of all target lesions),PR(at least a 30% decrease in the sum of the LD of target lesions),Progressive disease (PD:at least a 20% increase in the sum of the LD of target lesions, taking the smallest sum LD recorded as reference since the treatment started or the appearance of one or more new lesions) and Stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD).Evaluation of Non target Lesions included CR (disappearance of all non target lesions and normalization of tumor marker level), Incomplete response/SD (Persistence of 1 or more non target lesions and/or maintenance of tumor marker level above the normal limits) and PD(Appearance of 1 or more new lesions and/or unequivocal progression of existing non target lesions).|Phase 1: Day 21 of every other cycle (Cycle 2, 4, 6, 8) up to End of treatment (EOT) (Cycle10 or week 30)|The Response-Evaluable population is defined as all participants with measurable disease who receive at least 1 dose of MLN0264 and have at least 1 post baseline response assessment.|||participants|||Number
2581597|NCT02391038|Secondary|Phase 1- Number of Participants With Antitherapeutic Antibodies (ATAs)|Blood samples was collected predose to evaluate ATA. Data was collected only for limited period due to early termination of the study.|Day 1 of Cycle 1, 2, 3, 4: predose|Safety population included all participants who received any amount of study drug.|||participants|||Number
2581598|NCT02391038|Primary|Phase 2- Overall Response Rate|ORR is the percentage of participants with complete response [CR] + partial response [PR]) based on modified Response Evaluation Criteria in Solid Tumors (RECIST). Overall response rate (CR + PR) based on modified RECIST version 1.1 guidelines. CR: Disappearance of all target lesions and PR: at least a 30 percentage (%) decrease in the sum of the longest diameter (LD) of target lesions, taking the baseline sum LD as reference. All measurable lesions up to a maximum of 2 lesions per organ, 5 lesions in total representative of all involved organs were identified as target lesions at baseline. Target lesions were selected on the basis of size (longest lesions) and suitability for reproducible repeated measurements.|Baseline until end of study treatment (approximately 1 year)|Data was not reported for this measure as Phase 2 was not initiated, due to study termination during the dose-escalation portion of phase 1 consistent with the findings that preliminary PK and overall clinical data demonstrated compelling similarity between Western and Asian participant populations.||||||
2581599|NCT02391038|Primary|Phase 1: Cycle 2- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for MMAE||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.|||ng/mL||Standard Deviation|Geometric Mean
2581600|NCT02391038|Primary|Phase 1: Cycle 1- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for MMAE||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available.|||ng/mL||Standard Deviation|Geometric Mean
2581601|NCT02391038|Primary|Phase 1: Cycle 2- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for MMAE||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.|||day*ng/mL||Standard Deviation|Geometric Mean
2581602|NCT02391038|Primary|Phase 1: Cycle 1- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for MMAE||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available.|||day*ng/mL||Standard Deviation|Geometric Mean
2581603|NCT02391038|Primary|Phase 1: Cycle 2- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for MMAE||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.|||day*ng/mL||Standard Deviation|Geometric Mean
2581604|NCT02391038|Primary|Phase 1: Cycle 1- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for MMAE||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available.|||day*ng/mL||Standard Deviation|Geometric Mean
2581605|NCT02391038|Primary|Phase 1: Cycle 2- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MMAE||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day 1 PK assessment were available.|||day||Full Range|Median
2581606|NCT02391038|Primary|Phase 1: Cycle 1- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MMAE||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters.|||day||Full Range|Median
2581607|NCT02391038|Primary|Phase 1: Cycle 2- Cmax: Maximum Observed Plasma Concentration for MMAE||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MMAE concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day 1 PK assessment were available.|||ng/mL||Standard Deviation|Geometric Mean
2581610|NCT02391038|Primary|Phase 1: Cycle 1- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for TAb||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.|||mcg/mL||Standard Deviation|Geometric Mean
2581611|NCT02391038|Primary|Phase 1: Cycle 2- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for TAb||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.|||day*mcg/mL||Standard Deviation|Geometric Mean
2581612|NCT02391038|Primary|Phase 1: Cycle 1- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for TAb||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available.|||day*mcg/mL||Standard Deviation|Geometric Mean
2581613|NCT02391038|Primary|Phase 1: Cycle 2- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for TAb||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm because none of the participants had data evaluable for this measure.|||day*mcg/mL||Standard Deviation|Geometric Mean
2581614|NCT02391038|Primary|Phase 1: Cycle 1- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for TAb||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 1 Day 1 PK assessment were available.|||day*mcg/mL||Standard Deviation|Geometric Mean
2581615|NCT02391038|Primary|Phase 1: Cycle 2- Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAb||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day 1 PK assessment were available.|||day||Full Range|Median
2581616|NCT02391038|Primary|Phase 1: Cycle 1- Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAb||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters.|||day||Full Range|Median
2581617|NCT02391038|Primary|Phase 1: Cycle 2- Cmax: Maximum Observed Serum Concentration for TAb||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters where Cycle 2 Day 1 PK assessment were available.|||mcg/mL||Standard Deviation|Geometric Mean
2581618|NCT02391038|Primary|Phase 1: Cycle 1- Cmax: Maximum Observed Serum Concentration for Total Antibody (TAb)||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient TAb concentration time data to permit reliable estimation of the PK parameters.|||mcg/mL||Standard Deviation|Geometric Mean
2581619|NCT02391038|Primary|Phase 1: Cycle 2- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for MLN0264||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm as none of the participants had data evaluable for this measure.|||mcg/mL||Standard Deviation|Geometric Mean
2581620|NCT02391038|Primary|Phase 1: Cycle 1- Ctrough: Observed Concentration Measured at the End of a Dosing Interval for MLN0264||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 1 Day 1 PK assessment were available.|||mcg/mL||Standard Deviation|Geometric Mean
2581621|NCT02391038|Primary|Phase 1: Cycle 2- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for MLN0264||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available. Data is not reported for MLN0264 1.2 mg/kg arm as none of the participants had data evaluable for this measure.|||day*mcg/mL||Standard Deviation|Geometric Mean
2581622|NCT02391038|Primary|Phase 1: Cycle 1- AUCint: Area Under the Serum/Plasma Concentration-time Curve From Time 0 to End of the 21-day Dosing Interval (AUCint) for MLN0264||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 1 Day 1 PK assessment were available.|||day*mcg/mL||Standard Deviation|Geometric Mean
2581623|NCT02391038|Primary|Phase 1: Cycle 2- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for MLN0264||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available.|||day*mcg/mL||Standard Deviation|Geometric Mean
2581624|NCT02391038|Primary|Phase 1: Cycle 1- AUCinf: Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for MLN0264||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 1 Day 1 PK assessment were available.|||day*mcg/mL||Standard Deviation|Geometric Mean
2581625|NCT02391038|Primary|Phase 1: Cycle 2- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0264||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available.|||day||Full Range|Median
2581626|NCT02391038|Primary|Phase 1: Cycle 1- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0264||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure.|||day||Full Range|Median
2581627|NCT02391038|Primary|Phase 1: Cycle 2- Cmax: Maximum Observed Plasma Concentration for MLN0264||Day 1 of Cycle 2: predose and at multiple time points (up to 336 hours) post-dose|The PK evaluable population included all participants who received >=1 dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure where Cycle 2 Day 1 PK assessment were available.|||mcg/mL||Standard Deviation|Geometric Mean
2581628|NCT02391038|Primary|Phase 1: Cycle 1- Cmax: Maximum Observed Plasma Concentration for MLN0264||Day 1 of Cycle 1: predose and at multiple time points (up to 336 hours) post-dose|The Pharmacokinetic (PK) evaluable population included all participants who received greater than or equal to (>=1) dose of MLN0264 and had sufficient MLN0264 concentration time data to permit reliable estimation of MLN0264 exposure.|||microgram per milliliter (mcg/mL)||Standard Deviation|Geometric Mean
2581629|NCT02391038|Primary|Phase 1- Recommended Phase 2 Dose (RP2D)|RP2D is maximum tolerated dose(MTD) in study Phase1.MTD was highest dose of MLN0264 given at which <=1 of 6 participants experienced DLTduring Cycle1 of Phase1.DLT=any event related to MLN0264:Grade 4 neutropenia ANC less than<500 cells mm^3;>=Grade 3 neutropenia with fever/infection;Grade 4 thrombocytopenia(platelets <25,000/mm^3)/requires platelet transfusion(with/without hemorrhage);Grade 3/greater thrombocytopenia with clinically meaningful bleeding;Anemia requiring blood transfusion;>=Grade 3 nausea/emesis occurring despite using optimal anti-emetic prophylaxis;>=Grade 3 diarrhea despite optimal supportive care measures;any other >=Grade 3 nonhematologic toxicity except brief(<1 week)Grade 3 fatigue;Inability to start next therapy cycle>2 weeks due to delayed treatment and adequate recovery of MLN0264-related hematologic or nonhematologic toxicity;other>= Grade 2 MLN0264-related nonhematologic toxicity which requires dose reduction or discontinuation of therapy.|Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks)|The DLT-Evaluable population included all participants who either experienced DLT during Cycle 1 or received their scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT.|||mg/kg|||Number
2581630|NCT02391038|Primary|Phase 1- Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs include body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (beats per minute [bpm]).|Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks)|Safety population included all participants who received any amount of study drug.|||participants|||Number
2581631|NCT02391038|Primary|Phase 1- Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Laboratory assessment includes serum chemistry, hematology, urine analysis and coagulation.|Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks)|Safety population included all participants who received any amount of study drug.|||participants|||Number
2581632|NCT02391038|Primary|Phase 1- Number of Participants Experiencing Dose-limiting Toxicities (DLTs)|Toxicity evaluated as per NationalCancerInstituteCommonTerminologyCriteria for AEs (NCI CTCAE),version 4.03.DLT=any event related to MLN0264:Grade 4 neutropenia(absolute neutrophil count[ANC]less than[<]500 cells/millimeter[mm]^3); >=Grade 3 neutropenia with fever/infection;Grade 4 thrombocytopenia(platelets <25,000/mm^3)/requires platelet transfusion(with/without hemorrhage);Grade 3/greater thrombocytopenia with clinically meaningful bleeding;Anemia requiring blood transfusion;>=Grade 3 nausea/emesis occurring despite using optimal anti-emetic prophylaxis;>=Grade 3 diarrhea despite optimal supportive care measures;any other >=Grade 3 nonhematologic toxicity except brief(<1 week)Grade 3 fatigue;Inability to start next therapy cycle greater than (>)2 weeks due to delayed treatment and adequate recovery of MLN0264-related hematologic or nonhematologic toxicity;other>= Grade 2 MLN0264-related nonhematologic toxicity which requires dose reduction or discontinuation of therapy.|Phase 1: Up to Cycle 1 (3 weeks)|The DLT-Evaluable population included all participants who either experienced DLT during Cycle 1 or received their scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT.|||participants|||Number
2581633|NCT02391038|Primary|Phase 1- Number of Participants Reporting One or More Serious Adverse Events (SAE)||Phase 1: Baseline through 30 days after the last dose of study drug (Approximately up to 35 weeks)|Safety population included all participants who received any amount of study drug.|||participants|||Number
2581634|NCT02391038|Primary|Phase 1- Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)||Phase 1: Baseline through 30 days after the last dose of study drug (approximately up to 35 weeks)|Safety population includes all participants who received any amount of study drug.|||participants|||Number
2581635|NCT02390791|Secondary|Total Number of Measures Completed by Parents to Track Child Response to Treatment||6 months after starting treatment||||measures||Standard Deviation|Mean
2581636|NCT02390791|Secondary|Total Number of myADHDportal.Com Log-ins by Parent||6 months after starting treatment||||logins||Standard Deviation|Mean
2581637|NCT02390791|Secondary|Number of Participants With Side Effects Rated by Parents as Moderate or Severe on the Pittsburgh Side Effects Rating Scale|Number of Participants with side effects rated by parents as moderate or severe on the Pittsburgh Side Effects Rating Scale|6 months after starting treatment|population who completed this outcome assessment|||Participants|||Count of Participants
2581641|NCT02390791|Secondary|Parent Trust in Provider (Trust in Provider Scale)|Total score calculated from parent-report on the Trust in Provider Scale, range 10 to 50 with higher scores better (more trust)|6 months after starting treatment|population who completed this outcome assessment|||score on a scale||Inter-Quartile Range|Median
2581642|NCT02390791|Secondary|Parent-reported Decisional Conflict (Decisional Conflict Scale)|Total score calculated from parent-report on the Decisional Conflict Scale, range 0 to 100; higher scores are worse|6 months after starting treatment|population who completed this outcome assessment|||score on a scale||Inter-Quartile Range|Median
2581643|NCT02390791|Secondary|Parent-reported Necessity to Concerns Differential (Beliefs About Medication Scale)|Necessity to concerns differential score, range -4 to 4, positive scores mean necessity outweighs concerns, negative scores mean that concerns outweigh beliefs about necessity|6 months after starting treatment|population who completed this outcome assessment|||score on a scale||Inter-Quartile Range|Median
2581644|NCT02390791|Primary|Medication Continuity: The Number of Days Covered With Medicine|the number of days covered with medicine will be calculated from audit of prescriptions written|first 6 months of treatment||||Days||Standard Deviation|Mean
2581645|NCT02390557|Primary|Improved Quality of Care|% who agree that their quality of care Is better, the same or worse than before|12 months|315 participants completing wave 1 and wave 2 surveys|||Participants|||Count of Participants
2581646|NCT02390362|Secondary|Relapse Free at 12 Months||12 months|Study terminated early. Only 3 subjects enrolled. Data will not be posted to protect the subject identity.||||||
2581647|NCT02390362|Primary|Relapse Free Survival||6 months|Study terminated early. Only three subjects were enrolled and results will not be posted to protect subject confidentiality.||||||
2581648|NCT02390219|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Domain Score Through Week 24|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Baseline, Through Week 24|"FAS included all participants who were enrolled and administered any amount of study drug. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."|||Units on a scale||Standard Error|Least Squares Mean
2581649|NCT02390219|Secondary|Absolute Change From Baseline in Sweat Chloride at Average of Day 15 and Week 4|Sweat samples were collected using an approved collection device. Baseline was defined as the average of the measurements at screening and on Day 1 pre-dose. The average absolute change from baseline in sweat chloride was derived as: (Average of Day 15 and Week 4 value) minus Baseline value. Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Baseline, Day 15 and Week 4|"FAS included all participants who were enrolled and administered any amount of study drug. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."|||Millimoles per litre (mmol/L)||Standard Error|Mean
2581650|NCT02390219|Secondary|Number of Hospitalizations|Number of hospitalizations (all causes) through Week 24 was summarized. Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Baseline through Week 24|"FAS included all participants who were enrolled and administered any amount of study drug. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."|||Hospitalizations|||Number
2581651|NCT02390219|Secondary|Duration For Which Participants Received Intravenous (IV) Antibiotics|The duration for which participants received IV antibiotics for sinopulmonary signs and symptoms were reported. Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Baseline through Week 24|"FAS included all participants who were enrolled and administered any amount of study drug. Here, Number of Participants Analyzed signifies those participants who received at least one IV antibiotic for sinopulmonary signs and symptoms."|||Days||Standard Deviation|Mean
2581652|NCT02390219|Secondary|Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Up to Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Baseline, Up to Week 24|"FAS included all participants who were enrolled and administered any amount of study drug. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."|||Liter (L)||Standard Error|Least Squares Mean
2581653|NCT02390219|Secondary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Up to Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Baseline, Up to Week 24|"Full Analysis Set (FAS) included all participants who were enrolled and administered any amount of study drug. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure."|||Percent predicted of FEV1||Standard Error|Least Squares Mean
2581673|NCT02389946|Secondary|Number of Participants With Stent Thrombosis|Stent thrombosis according to the Academic Research Consortium criteria.|Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years||2022-04-30|04/2022||||
2581674|NCT02389946|Secondary|Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components|TVF: composite of cardiac death, target vessel Q-wave or non-Q-wave MI, and any clinically-driven TVR.|Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years||2022-04-30|04/2022||||
2582829|NCT02374060|Secondary|Number of Eyes With Retinal Tear or Detachment|Count of eyes with retinal tears or detachments during the course of follow-up.|During 24 weeks of follow-up||||Eyes with uveitic macular edema|Eyes with uveitis macular edema||Number
2581654|NCT02390219|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; event does not necessarily have a causal relationship with treatment. This includes any newly occurring event/previous condition that has increased in severity/frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event, which falls into any of the following categories, regardless of its relationship to study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. TEAEs: AEs that started/ worsened on/after the start of study drug through the Safety Follow up Visit (4 weeks after the last dose of study drug). Results were reported as planned, as a combined single LUM/IVA arm irrespective of permitted dose modification.|Day 1 up to Week 28|Safety Set included all participants who were exposed to any amount of study drug.|||Participants|||Count of Participants
2581655|NCT02390167|Secondary|Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method|Untrained subject WITH and WITHOUT diabetes self-tested Alternate Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (< 75 mg/dL YSI capillary plasma) and +/- 15% (>= 75 mg/dL YSI capillary plasma).|1 hour|366 (375-9) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol.|||Percent of Results within 15mg/dL/15%|||Number
2581656|NCT02390167|Secondary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method|Untrained subject WITH and WITHOUT diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (< 75 mg/dL YSI capillary plasma) and +/- 15% (>= 75 mg/dL YSI capillary plasma).|1 hour|372 (375 - 3) Blood glucose results were analyzed. Three subjects did not obtain meter BG results after three attempts.|||Percent of Results within 15mg/dL/15%|||Number
2581657|NCT02390167|Secondary|Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding Views/Behaviors Related to Self-Monitoring Blood Glucose|Staff obtained responses from persons WITH Diabetes using short questionnaires to provide feedback on views and behaviors related to managing their diabetes. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree' or 'Choose Not to Answer'.|1 hour||||Percent of Subjects who responded|||Number
2581658|NCT02390167|Secondary|Percent of Responses From Persons WITH and WITHOUT Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS|Staff obtained responses from persons WITH and WITHOUT Diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'.|1 hour||||Percent of Subjects who responded|||Number
2581659|NCT02390167|Secondary|Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS|Staff obtained responses from persons WITH Diabetes (332) using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'.|1 hour||||Percent of Subjects who responded|||Number
2581660|NCT02390167|Secondary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 12.5mg/dL (<100mg/dL) and Within +/- 12.5% (>=100 mg/dL) of Laboratory Glucose Method|Untrained subjects WITH Diabetes (332) self-tested fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 12.5 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 12.5% (>=100 mg/dL YSI capillary plasma).|1 hour|329 (332-3) Blood glucose results were analyzed. Three subjects did not obtain meter BG result after three attempts.|||Percent of Results within12.5mg/dL/12.5%|||Number
2581661|NCT02390167|Secondary|Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Tested By Study Staff|Study staff tested subject (332 WITH and 43 WITHOUT diabetes) fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 20% of the laboratory method across the entire tested YSI glucose range.|1 hour|375 Blood glucose results were analyzed.|||Percent of Results within 20%|||Number
2581662|NCT02390167|Secondary|Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Tested By Study Staff|Study staff tested subject (332 WITH and 43 WITHOUT diabetes) fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15% of the laboratory method across the entire tested YSI glucose range.|1 hour|375 Blood glucose results were analyzed.|||Percent of Results within 15%|||Number
2581663|NCT02390167|Secondary|Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested AST palm blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 20% of the laboratory reference method across the entire tested YSI glucose range.|1 hour|361 (375-14) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol. Five (5) subjects had low blood sugar; their palm results were not evaluable per protocol.|||Percent of Results within 20%|||Number
2581664|NCT02390167|Secondary|Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested AST palm blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15% of the laboratory reference method across the entire tested YSI glucose range.|1 hour|361 (375-14) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol. Five (5) subjects had low blood sugar; their palm results were not evaluable per protocol.|||Percent of Results within 15%|||Number
2581665|NCT02390167|Secondary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested Fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 20% of the laboratory reference method across the entire tested YSI glucose range.|1 hour|372 (375-3) Blood glucose results were analyzed. Three subjects did not contain meter BG results after three attempts.|||Percent of Results within 20%|||Number
2581666|NCT02390167|Secondary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH Diabetes (332) and WITHOUT Diabetes (43) self-tested fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15% of the laboratory reference method across the entire tested YSI glucose range.|1 hour|372 (375-3) Blood glucose results were analyzed. Three subjects did not obtain meter BG results after three attempts.|||Percent of Results within 15%|||Number
2581667|NCT02390167|Secondary|Percent of Venous Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Tested by Study Staff|Study staff tested venous blood of 332 subjects WITH diabetes using an Investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI venous plasma) and +/- 15% (>=100 mg/dL YSI venous plasma).|1 hour|330 (332-2) Blood glucose results were analyzed. Two (2) subjects had unsuccessful venipuncture attempts, so no venous results were obtained for them.|||Percent of Results within 15mg/dL/15%|||Number
2581668|NCT02390167|Secondary|Percent of Subject Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Tested by Study Staff|Study staff tested subject (332 WITH diabetes) fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 15% (>=100 mg/dL YSI capillary plasma).|1 hour|332 Blood glucose results from subjects with diabetes were analyzed.|||Percent of Results within 15mg/dL/15%|||Number
2581669|NCT02390167|Secondary|Percent of Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Untrained subjects WITH Diabetes (332) self-tested Alternate Site (AST) palm blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 15% (>=100 mg/dL YSI capillary plasma).|1 hour|318 (332 with diabetes -14) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol. Five (5) subjects had low blood sugar; their palm results were not evaluable per protocol.|||Percent of Results within 15mg/dL/15%|||Number
2581670|NCT02390167|Primary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Untrained subjects WITH Diabetes (332) self-tested fingerstick blood using an Investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (<100 mg/dL YSI capillary plasma) and +/- 15% (>=100 mg/dL YSI capillary plasma).|1 hour|329 (332 with diabetes-3) Blood glucose results were analyzed. Three subjects did not obtain meter BG result after three attempts.|||Percent of Results within 15mg/dL/15%|||Number
2581671|NCT02390076|Secondary|Biased Attention for Emotional Stimuli Measured by the Dot Probe Task|This task measures biased attention for emotional stimuli. In this task, two stimuli are presented at the same time. The investigators plan to present two words concurrently; one emotionally valenced word (positive or negative) and one neutral word. Two words appear on the screen for 1000 ms; the location of the emotional and neutral word varies randomly. Following the offset of the words, a subsequent target (i.e., O or Q) appears; the location of the target is randomized with the constraint that it must appear an equal number of times behind the emotional and neutral words. Each iteration of the dot probe task will include 96 trials, and will last approximately 7 minutes. Behavioral reaction times are recorded via a button push on the response box. Change in negative bias is calculated as mean bias value from the dot probe task at the end of session 2 minus the mean bias value calculated at the beginning of session 1.|Measure was administered at the beginning of session 1 and end of session 2.||||change in negative bias (ms)||Standard Deviation|Mean
2581672|NCT02390076|Primary|Presence and Severity of Depressive Symptoms Assessed by Center for Epidemiologic Studies - Depression Scale (CES-D)|The CES-D (Radloff, 1977) is a 20-item, self-report scale designed to assess the presence and severity of depressive symptoms over the past week. The total range is 0-80, with higher scores reflecting more severe depression symptoms. Outcome measure data table reflects clinical symptoms at 2 week follow-up.|At baseline, session 1, session 2, 1 week follow-up, and 2 week follow-up.||||units on a the CESD scale||Standard Deviation|Mean
2581675|NCT02389946|Secondary|Number of Participants With TLF and Individual TLF Components|TLF: composite of cardiac death, target vessel Q-wave or non-Q-wave MI, and any clinically-driven TLR|Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years||2022-04-30|04/2022||||
2581676|NCT02389946|Secondary|Number of Participants With MACE and Individual MACE Components|MACE: composite of all-cause death, Q-wave or non-Q-wave MI, and any clinically-driven TLR|Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years||2022-04-30|04/2022||||
2581677|NCT02389946|Secondary|Number of Participants With Myocardial Infarction or Cardiac Death|Anticipated reporting: April 2022.|Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years||2022-04-30|04/2022||||
2581678|NCT02389946|Secondary|Number of Participants With Myocardial Infarction||Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 years||2022-04-30|04/2022||||
2581679|NCT02389946|Secondary|Number of Participants With Procedure Success|Defined as attainment of < 30% residual stenosis of the target lesion using the assigned study stent only without occurrence of in-hospital major adverse cardiac events (MACE; composite of all-cause death, Q-wave or non-Q-wave MI, and any clinically-driven TLR).|Hospital Discharge (6-24 hours post-index procedure)|Procedure success was analyzed per subject: for a subject to be considered a procedure success, all of the subject's target lesions had to be considered device success. Lesions that were not treated and lesions missing both site-reported and core lab-assessed percent residual stenosis were excluded from the analysis.|||Participants|||Count of Participants
2581680|NCT02389946|Secondary|Number of Lesions With Lesion Success|Defined as attainment of < 30% residual stenosis of the target lesion using any percutaneous method.|Hospital Discharge (6-24 hours post-index procedure)|Lesion Success per lesion. Lesions that were not treated and lesions missing both site-reported and core lab-assessed percent residual stenosis were excluded from the analysis.|||Lesions|Lesions||Count of Units
2581681|NCT02389946|Secondary|Number of Lesions With Device Success|Defined as attainment of < 30% residual stenosis of the target lesion using the assigned study stent only.|Hospital Discharge (6-24 hours post-index procedure)|Device Success per lesion. Lesions that were not treated and lesions missing both site-reported and core lab-assessed percent residual stenosis were excluded from the analysis.|||Lesions|Lesions||Number
2581682|NCT02389946|Primary|Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure by Bayesian Estimation|TLF is defined as all cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).|12-Months|Pre-specified Bayesian analysis: BIOFLOW-V intent-to-treat subjects who experienced the primary endpoint or had at least 330 days of follow-up and BIOFLOW-II (NCT01356888) and BIOFLOW-IV (NCT01939249) subjects who satisfied the BIOFLOW-V inclusion/exclusion criteria and experienced the primary endpoint or had at least 330 days of follow-up.|||Percentage of participants||Standard Deviation|Mean
2581683|NCT02389894|Secondary|Number of Participants With Emboli Captured|Assessed by the presence of any debris captured in filter of embolic protection device|day 1|Emboli are not captured by the standard cannula and therefore no data are available for this group in this outcome measure|||Participants|||Count of Participants
2581684|NCT02389894|Secondary|Quality of Life - Mental Health Composite|Quality of life - Mental health composite Assessed by Short Form-12 (SF-12). Score ranking from 0 (worst health) to 100 (best health) calculated as the weighted sum of the questions. health scores then transformed into a t-score on the assumption that each question carries equal weight and were standardized to have mean of 50 and standard deviation of 10.|at 90 days||||T-Score||Standard Deviation|Mean
2581685|NCT02389894|Secondary|Quality of Life - Physical Health Composite|Quality of Life - Physical Health Composite Assessed by Short Form-12 (SF-12). Score ranking from 0 (worst health) to 100 (best health) calculated as the weighted sum of the questions. health scores then transformed into a t-score on the assumption that each question carries equal weight and were standardized to have mean of 50 and standard deviation of 10.|at 90 days||||T-Score||Standard Deviation|Mean
2581686|NCT02389894|Secondary|Hospital Readmissions|Rate of hospital readmissions|up to 90 days||||rate per 100-patient-months|||Number
2581687|NCT02389894|Secondary|Length of Stay for Index Hospitalization||up to 90 days||||days||Standard Deviation|Mean
2581688|NCT02389894|Secondary|Mortality by 90 Days|Incidence of all-cause mortality|up to 90 days||||Participants|||Count of Participants
2581689|NCT02389894|Secondary|Number of Participants With Confusion Assessment Method (CAM) Delirium Assessment at 7 Days||7 days||||Participants|||Count of Participants
2581690|NCT02389894|Secondary|Barthel Index <= 80|An overall score has full range from 0 to 100, with higher scores indicating greater independence.|90 days||||Participants|||Count of Participants
2581691|NCT02389894|Secondary|Modified Rankin Scale >2 at 90 Days|"The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead."|90 days||||Participants|||Count of Participants
2581692|NCT02389894|Secondary|Decline in Neurocognitive Function in the Visuomotor/Information Processing Speed Domain at 90 Days|Decline in neurocognitive function in the Visuomotor/Information Processing Speed domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.|baseline and 90 days||||Participants|||Count of Participants
2581693|NCT02389894|Secondary|Decline in Neurocognitive Function in the Auditory-Verbal Simple Attention Domain at 90 Days|Decline in neurocognitive function in the Auditory-Verbal Simple attention domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.|baseline and 90 days||||Participants|||Count of Participants
2582830|NCT02374060|Secondary|Number of Eyes With Vitreous Hemorrhage|Count of eyes with vitreous hemorrhage as an immediate complication of injection.|During 24 weeks of follow-up||||Eyes with uveitic macular edema|Eyes with uveitis macular edema||Number
2581694|NCT02389894|Secondary|Decline in Neurocognitive Function in the Visuospatial/Constructional Praxis Domain at 90 Days|Decline in neurocognitive function in the visuospatial/constructional praxis domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.|baseline and 90 days||||Participants|||Count of Participants
2581695|NCT02389894|Secondary|Decline in Neurocognitive Function in the Executive Function Domain at 90 Day|Decline in neurocognitive function in the executive function domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.|baseline and 90 days||||Participants|||Count of Participants
2581696|NCT02389894|Secondary|Decline in Neurocognitive Function in the Visual Memory Domain at 90 Days|Decline in neurocognitive function in the visual memory domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.|baseline and 90 days||||Participants|||Count of Participants
2581697|NCT02389894|Secondary|Decline in Neurocognitive Function in the Verbal Memory Domain at 90 Days|Decline in neurocognitive function in the verbal memory domain at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.|baseline and 90 days||||Participants|||Count of Participants
2581698|NCT02389894|Secondary|Decline in Overall Neurocognition|Decline in neurocognitive function at 90 days as compared to baseline. Decline defined as the number of patients whose Z score (computed relative to the study population at baseline, adjusting for age, education and sex) at day 90 had decreased by 0.5 SD relative to the baseline score.|baseline and 90 days||||Participants|||Count of Participants
2581699|NCT02389894|Secondary|Total Infarct Volume|Total infarct volume measured on day 7 dwMRI.|Day 7|Analysis population includes all those with dwMRI at 7 days|||mm^3||Inter-Quartile Range|Median
2581700|NCT02389894|Secondary|Presence of Radiographic Infarcts|The proportion of patients with radiographic infarcts on day 7 (+/-3 days) MRI. Presences of radiographic infarcts were measured using diffusion-weighted 1.5 or 3T MRI scanners|up to 10 days|Denominator includes all patients with day 7 MRI|||Participants|||Count of Participants
2581701|NCT02389894|Secondary|Number of Patients With Clinically Apparent Stroke at 7 Days|The number of patients who experience a clinically apparent stroke by 7 days post-op|at 7 days|Two patients withdrew prior to day 7|||Participants|||Count of Participants
2581702|NCT02389894|Secondary|Number of Participants With a Composite Endpoint of Mortality, Clinical Stroke, and Acute Kidney Injury|The number of patients who have had a clinical ischemic stroke, acute kidney injury (AKI), or death within 30 days of surgery.|up to 30 days|Three patients withdrew prior to day 30 and are not included in the denominators|||Participants|||Count of Participants
2581703|NCT02389894|Primary|Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction|freedom from CNS infarction, defined as brain, spinal cord, or retinal cell death attributable to ischemia based on neuropathological, neuroimaging, or clinical evidence of permanent injury based on symptoms persisting > 24 hours, with overt symptoms or no known symptoms. All patients will be assessed by 1.5 T (3.0 T is acceptable if 1.5 T not available) Diffusion-weighted imaging (DWI) at 7 (± 3) days post procedure for presence of brain lesions and to measure the number and volume of any present lesions.|up to 10 days post procedure||||percentage of participants||95% Confidence Interval|Number
2581704|NCT02389881|Secondary|Mean AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-058|Area under the plasma concentration-time curve during a dosing interval, where tau (τ) is the length of the dosing interval.|Day 10 predose and at multiple time points (up to 24 hours) postdose|Pharmacokinetic Set, all participants who were in the safety set and had at least 1 measurable plasma concentration or amount of drug in urine.|||ng*hr/mL||Standard Deviation|Mean
2581705|NCT02389881|Secondary|Mean AUC24: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-058|AUC24 is measure of area under the curve from time 0 to 24 hours postdose.|Day 1 predose and at multiple time points (up to 24 hours) postdose|Pharmacokinetic Set, all participants who were in the safety set and had at least 1 measurable plasma concentration or amount of drug in urine.|||ng*hr/mL||Standard Deviation|Mean
2581706|NCT02389881|Secondary|Mean AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-058|AUClast is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration.|Day 1 predose and at multiple time points (up to 72 hours) postdose|Pharmacokinetic Set, all participants who were in the safety set and had at least 1 measurable plasma concentration or amount of drug in urine.|||ng*hr/mL||Standard Deviation|Mean
2581707|NCT02389881|Secondary|Mean Cmax: Maximum Observed Plasma Concentration for TAK-058|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 predose and at multiple time points (up to 72 hours) postdose, and Day 10 predose and at multiple time points (up to 24 hours) postdose|Pharmacokinetic Set, all participants who were in the safety set and had at least 1 measurable plasma concentration or amount of drug in urine.|||ng/mL||Standard Deviation|Mean
2581708|NCT02389881|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Signs at Least Once Post-Dose|The percentage of participants with any markedly abnormal standard vital sign values collected throughout study. Vital signs included blood pressure (after 5 minutes supine and at 1 and 3 minutes after standing), pulse and oral temperature.|Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14|Safety Set, all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2581709|NCT02389881|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-Dose|The percentage of participants with any markedly abnormal standard safety laboratory values (chemistry and hematology) collected throughout study.|Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14|Safety Set, all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2581710|NCT02389881|Primary|Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Cohorts 1-4 Day 1 to Day 40; Cohort 5 Day 1 to Day 14|Safety Set, all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2581711|NCT02389829|Secondary|Number of Participants Who Achieved Short Term Headache Freedom; Assessed by Telephone Questionnaire|Participants were asked to evaluate pain status since discharge. Participants who achieved total headache freedom for at least 1 hour are considered to achieve short term headache relief.|48 hours after discharge from Emergency Department||||Participants|||Count of Participants
2581712|NCT02389829|Secondary|Number of Participants Who Achieved Short Term Headache Relief, Assessed by Telphone Questionnaire|"Participants were asked to make evaluation of pain status since discharge. Those achieving headache level mild or none for 1 hour are considered to achieve short term headache relief."|48 hours after discharge from Emergency Department||||Participants|||Count of Participants
2581713|NCT02389829|Secondary|Number of Participants Needing Rescue Medication as Assessed by Questionnaire|Data collected by telephone. Patients were asked if they needed additional medication after discharge in order to reduce level of pain. This additional medication is considered rescue medication.|48 hours after discharge from Emergency Department||||Participants|||Count of Participants
2581714|NCT02389829|Primary|Number of Participants With Sustained Headache Relief Assessed by Self-evaluation|"Sustained headache relief is defined as achieving a headache level of mild or none within two hours and maintaining a level of mild or none for 48 hours, without use of addition medication. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after medication administration."|up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department||||Participants|||Count of Participants
2581715|NCT02389816|Secondary|Change From Baseline in Perceived Deficits Questionnaire (PDQ-5) Total Score to Week 8 (LOCF)|PDQ-5 is a self-administered 5-item questionnaire to assess cognition function, including subscales of attention/concentration, retrospective memory, prospective memory, and planning/organization. PDQ-5 total score ranges from 0 to 20 with smaller scores indicate greater cognitive function.|Baseline (At the start of double-blind treatment period), up to 8 weeks|FAS: All participants who were randomized and received at least 1 dose of the study drug in the double-blind treatment period. Here, number analyzed is the number of participants who were evaluable at each category.|||Scores on a scale||Standard Error|Least Squares Mean
2581716|NCT02389816|Secondary|Change From Baseline in Digit Symbol Substitution Test (DSST) Total Score to Week 8 (LOCF)|The DSST is a neuropsychological test to assess cognitive function. Participants are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time for a total possible score of 0 to 133. Higher scores-correct number of symbols reflects greater objective cognitive functioning. An increase in score represents an improvement in an integrated measure of cognitive function.|Baseline (At the start of double-blind treatment period), up to 8 weeks|FAS: All participants who were randomized and received at least 1 dose of the study drug in the double-blind treatment period. Here, number analyzed is the number of participants who were evaluable at each category.|||Scores on a scale||Standard Error|Least Squares Mean
2581717|NCT02389816|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score to Week 8 (LOCF)|The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.|Baseline (At the start of double-blind treatment period), up to 8 weeks|FAS: All participants who were randomized and received at least 1 dose of the study drug in the double-blind treatment period. Here, number analyzed is the number of participants who were evaluable at each category.|||Scores on a scale||Standard Error|Least Squares Mean
2581718|NCT02389816|Secondary|Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score to Week 8 (LOCF)|The CGI-S assesses the impression of the participant's current state of mental illness. The current severity of mental illness is rated on a seven-point scale (1=normal, not ill at all ~ 7=most extremely ill) based on a total clinical experience. Higher scores indicate greater severity of mental illness.|Baseline (At the start of double-blind treatment period), up to 8 weeks|FAS: All participants who were randomized and received at least 1 dose of the study drug in the double-blind treatment period. Here, number analyzed is the number of participants who were evaluable at each category.|||Scores on a scale||Standard Error|Least Squares Mean
2581719|NCT02389816|Secondary|Clinical Global Impressions-Improvement (CGI-I) Score at Week 8 (LOCF)|The CGI-I assesses the participant's state of mental illness improvement. The participant's condition compared to baseline is rated on a seven-point scale (1=very much improved ~ 7=very much worse). Higher scores indicate greater worsening of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms.|Week 8|FAS: All participants who were randomized and received at least 1 dose of the study drug in the double-blind treatment period. Here, number analyzed is the number of participants who were evaluable at each category.|||Scores on a scale||Standard Error|Least Squares Mean
2581720|NCT02389816|Secondary|Change From Baseline in Hamilton Depression Scale (HAM-D17) Total Score to Week 8 (LOCF)|The HAM-D17 is a clinician-rated scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52 where a higher score indicates a greater depressive state.|Baseline (At the start of double-blind treatment period), up to 8 weeks|FAS: All participants who were randomized and received at least 1 dose of the study drug in the double-blind treatment period. Here, number analyzed is the number of participants who were evaluable at each category.|||Scores on a scale||Standard Error|Least Squares Mean
2581721|NCT02389816|Secondary|MADRS Remission at Week 8 (LOCF)|Reported data was percentage of participants who met MADRS remission criteria (defined as a MADRS total score ≤10) at Week 8 for each group. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension). MADRS corresponds to core symptoms of depression, and rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement.|Week 8|FAS: All participants who were randomized and received at least 1 dose of the study drug in the double-blind treatment period. Here, number analyzed is the number of participants who were evaluable at each category.|||Percentage of Participants|||Number
2581722|NCT02389816|Secondary|MADRS Response at Week 8 (Last Observation Carried Forward (LOCF))|Reported data was percentage of participants who met MADRS response criteria (defined as a ≥50% decrease in the MADRS total score from Baseline) at Week 8 for each group. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension). MADRS corresponds to core symptoms of depression, and rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement.|Week 8|FAS: All participants who were randomized and received at least 1 dose of the study drug in the double-blind treatment period. Here, number analyzed is the number of participants who were evaluable at each category.|||Percentage of Participants|||Number
2581723|NCT02389816|Primary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Week 8|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension). MADRS corresponds to core symptoms of depression, and rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement.|Baseline (At the start of double-blind treatment period), up to 8 weeks|Full Analysis Set (FAS): All participants who were randomized and received at least 1 dose of the study drug in the double-blind treatment period.|||Scores on a scale||Standard Error|Least Squares Mean
2581724|NCT02389764|Secondary|Safety Measures of BIBF 1120 in Terms of Type, Frequency and Severity of Adverse Event According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 in Patients With Metastatic IBC.|An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationship with this treatment. All adverse events (grade 3 or higher for hematological toxicity, grade 2 or higher for non-hematological toxicity)|2 years||||participants|||Number
2581725|NCT02389764|Primary|Clinical Benefit Rate (Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Date) of BIBF 1120 (Nintedanib) in Patients With HER2-negative Metastatic Inflammatory Breast Cancer (IBC).|"Clinical benefit defined as participants who achieve CR or PR within 3 months post-treatment, or participants who experience SD for at least three months post-treatment. Clinical benefit rate determined by RECIST 1.1 version. PATHOLOGICAL CR: No evidence of residual invasive tumor, including no residual tumor in the axillary lymph nodes. PR is defined as 30% or greater decrease for a minimum of 4 weeks in the measurable lesion as determined by the product of the perpendicular diameters of the lesion. Every lesion should not regress to qualify as a PR. However, if any lesion progresses or if new lesions appear, the response cannot be classified as a (PR). Minor Response [MR] Decreases in tumor masses insufficient to qualify as a partial remission, i.e. <50%. SD between MR and PD. PD increase in the size by 25% of any measured lesion from baseline. Appearance of new lesions will also constitute increasing disease. Mixed responses will be considered PD."|2 years||||Participants|||Count of Participants
2581726|NCT02389738|Secondary|Evaluation of Relationaship Between Cognitive/Mood Disorders and Expression of Biochemical Markers Post-op Day 1|The study of collecting biochemical markers of glioma with correlation to current or past cognitive/mood disorders with Montgomery-Asberg. Biomarkers will be obtained post-op day 1 from dialysate collections and later identified and quantified.|24 hours post-op|||||||
2581727|NCT02389738|Primary|Change in AUC0-18 of the Temozolomide Concentration (AUC-T) in Brain Interstitium Before and After Regadenoson Infusion|The AUC-T for each day will be estimated by the trapezoid rule, based on the number of time points available for the particular evaluable patient. The PK variables will be tabulated and descriptive statistics calculated pre and post Regadenoson. The difference of AUCs will be summarized by mean and standard deviation or median and range if there is large variation from patient to patient. Means and standard deviation or mean and range will be presented for Cmax and AUC(inf) for each group. Graphic method will be used to display the difference for individual patient and all five patients.|18 hours post temozolomide administration||||percentage of AUC||Full Range|Mean
2581728|NCT02389725|Secondary|Rate of Rescue Techniques Used|The number of subjects requiring one or more rescue techniques to access peripheral IV. These techniques include ultrasound guided peripheral IV access, central venous access, venous cut-down, interosseous access, and/or change in treatment plan due to unsuccessful access.|baseline||||Participants|||Count of Participants
2581729|NCT02389725|Secondary|Total Number of Distinct Providers That Attempted IV Access|Total number of individual medical providers that attempt to access IV for each subject. An attempt is defined as a needle penetrating the surface of the subject's skin. Access was defined as good flow through an IV catheter with a saline flush and without subcutaneous fluid collection.|baseline||||Participants|||Count of Participants
2581730|NCT02389725|Secondary|Total Number of Peripheral IV Access Attempts|The total number of peripheral IV access attempts for each subject., up to a maximum of four attempts. An attempt is defined as a needle penetrating the subject's skin surface.|baseline||||Participants|||Count of Participants
2581731|NCT02389725|Primary|Peripheral IV Access Success Rate|Peripheral IV access success rate is defined as the number of subjects who had successful peripheral intravenous cannulation on the first attempt. An attempt was defined as a needle penetrating the surface of the subject's skin. Successful access was defined as good flow through an IV catheter with a saline flush and without subcutaneous fluid collection.|baseline||||Participants|||Count of Participants
2581732|NCT02389712|Primary|Inventory for Depressive Symptoms||12 weeks|Study was terminated due to difficulties with recruitment||||||
2581733|NCT02389621|Secondary|Apparent Total Clearance (CL/F) of Lusutrombopag||Day 5, predose and 2, 4, 6, 8, 24, and 48 hours post-dose (24 and 48 hours post-dose = Day 6 and Day 7 prior to dose on that day).|Participants in the intensive pharmacokinetic (PK) sampling group with at least 1 PK parameter estimated.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2581734|NCT02389621|Secondary|Area Under the Plasma Concentration-time Curve Over the Dosing Interval τ (AUC0-τ) for Lusutrombopag||Day 5, predose and 2, 4, 6, 8, 24, and 48 hours post-dose (24 and 48 hours post-dose = Day 6 and Day 7 prior to dose on that day).|Participants in the intensive pharmacokinetic (PK) sampling group with at least 1 PK parameter estimated.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2581735|NCT02389621|Secondary|Time to Maximum Plasma Concentration (Tmax) of Lusutrombopag||Day 5, predose and 2, 4, 6, 8, 24, and 48 hours post-dose (24 and 48 hours post-dose = Day 6 and Day 7 prior to dose on that day).|Participants in the intensive pharmacokinetic (PK) sampling group with at least 1 PK parameter estimated.|||hours||Full Range|Median
2581736|NCT02389621|Secondary|Maximum Plasma Concentration (Cmax) of Lusutrombopag||Day 5, predose and 2, 4, 6, 8, 24, and 48 hours post-dose (24 and 48 hours post-dose = Day 6 and Day 7 prior to dose on that day).|Participants in the intensive pharmacokinetic (PK) sampling group with at least 1 PK parameter estimated.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2581737|NCT02389621|Secondary|Number of Participants With Adverse Events (AEs)||From first dose of study drug to 28 days after the last dose, 35 days.|All randomized participants who received at least 1 dose of the study drug.|||Participants|||Count of Participants
2581738|NCT02389621|Secondary|Change From Baseline in Platelet Count Over Time||Baseline and Days 5, 6, 7, 8, 10, 12, 14, 17, 21, 28, and 35.|All randomized participants with available data at each time point.|||* 10⁹/L||Standard Deviation|Mean
2581739|NCT02389621|Secondary|Number of Participants With Specified Total Number of Platelet Transfusions|The number of transfusions administered to each patient were collected over the duration of the trial. The data are presented as the number of patients with the highest total number of transfusions followed by the next highest number of transfusions, etc.|From Day 1 to the end of the posttreatment period, 35 days.|All randomized participants (intent-to-treat population)|||Participants|||Count of Participants
2581740|NCT02389621|Secondary|Percentage of Participants Who Required Rescue Therapy for Bleeding During the Study|Participants who received rescue therapy for bleeding events during the study. Platelet preparations, other blood preparations (including red blood cells and plasma), and volume expanders were considered as rescue therapy for bleeding events.|From Day 1 to the end of the possttreatment period, 35 days.|All randomized participants (intent-to-treat population)|||percentage of participants|||Number
2581741|NCT02389621|Secondary|Duration of Increase in Platelet Count to ≥ 50 × 10⁹/L by Platelet Transfusion Status|The duration of the increase in platelet count was defined as the number of days during which the platelet count was maintained as ≥ 50 × 10⁹/L.|From Day 1 to the end of the posttreatment period, 35 days.|All randomized participants with available data|||days||Inter-Quartile Range|Median
2581742|NCT02389621|Secondary|Duration of Increase in Platelet Count to ≥ 50 × 10⁹/L|The duration of the increase in platelet count was defined as the number of days during which the platelet count was maintained as ≥ 50 × 10⁹/L.|From Day 1 to the end of the posttreatment period, 35 days.|All randomized participants with available data|||days||Inter-Quartile Range|Median
2581743|NCT02389621|Secondary|Percentage of Participants With a Response|A response was defined as a platelet count of ≥ 50 × 10⁹/L with an increase of ≥ 20 × 10⁹/L from Baseline at any time during the study. Participants who met this response criterion only after platelet transfusion were considered as nonresponders.|From Day 1 to the end of the posttreatment period, 35 days.|All randomized participants (intent-to-treat population)|||percentage of participants||95% Confidence Interval|Number
2581744|NCT02389621|Secondary|Percentage of Participants Who Required no Platelet Transfusion During the Study|Participants who did not undergo the invasive procedure were considered as having received platelet transfusion.|From Day 1 to end of the posttreatment period, 35 days.|All randomized participants (intent-to-treat population)|||percentage of participants||95% Confidence Interval|Number
2581745|NCT02389621|Primary|Percentage of Participants Who Required No Platelet Transfusion Prior to the Primary Invasive Procedure and No Rescue Therapy For Bleeding From Randomization Through 7 Days After the Primary Elective Procedure|"Participants were considered as meeting the primary endpoint if all of the following conditions were satisfied:~Required no platelet transfusion from the date of randomization through at least 7 days after the primary invasive procedure~Did not receive the following rescue therapy for bleeding from the date of randomization through 7 days after the primary invasive procedure~Platelet preparations~Other blood preparations, including red blood cells and plasma~Volume expanders~Underwent an invasive procedure. Participants who received at least one platelet transfusion prior to the primary invasive procedure, received at least one rescue therapy for bleeding from the date of randomization through 7 days after the primary invasive procedure, discontinued from the study before undergoing the primary invasive procedure, or did not undergo an invasive procedure were considered as not meeting the primary endpoint."|From Randomization to 7 days after the invasive procedure, up to approximately 21 days.|All randomized participants (intent-to-treat population)|||percentage of participants||95% Confidence Interval|Number
2581746|NCT02389452|Secondary|Change From Baseline in WOMAC C Score After Repeat Injection|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) calculated as a mean of 17 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).|Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)|Repeat intent to treat population.|||units on a scale||Standard Deviation|Mean
2581789|NCT02388932|Primary|Maximum Tolerated Dose (MTD) of Head and Neck SBRT|Maximum tolerated dose of SBRT in this patient population determined by the dose escalation design with doses '40Gy' and '45Gy all in 5 fractions'.|3 months|Patients who received treatment. MTD was not able to be determined because only three patients enrolled and no DLTs were observed. A recommended MTD could only be made if enough patients had accrued to assess toxicities in the different dosage levels.||||||
2581747|NCT02389452|Secondary|Change From Baseline in WOMAC B Score After Repeat Injection|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC B (measure of stiffness) calculated as a mean of 2 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of joint. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).|Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)|Repeat intent to treat population.|||units on a scale||Standard Deviation|Mean
2581748|NCT02389452|Secondary|Change From Baseline in WOMAC A Score After Repeat Injection|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) calculated as a mean of 5 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher pain. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).|Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)|Repeat Intent to treat population included all participants who were eligible for repeat treatment and received at least one repeat dose of study medication.|||units on a scale||Standard Deviation|Mean
2581749|NCT02389452|Secondary|Change From Baseline in WOMAC A1 Subscore After Repeat Injection|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain. Data are reported for those participants who received repeat injection. Here, baseline represents the day at which a participant received repeat injection (Week 26, 39 or 52).|Baseline; Weeks 1, 4 after repeat injection (missing data imputed by LOCF)|Repeat Intent to treat population included all participants who were eligible for repeat treatment and received at least one repeat dose of study medication.|||units on a scale||Standard Deviation|Mean
2581750|NCT02389452|Secondary|Time Between Initial and Repeat Synvisc-One Treatment|Time Between initial and repeat Synvisc-One Treatment was duration between initial and repeat injection in those participants who received repeat injection.|Baseline up to Week 52|ITT population. Number of participants analysed = participants from ITT population who received repeat injection.|||weeks||Standard Deviation|Mean
2581751|NCT02389452|Secondary|Number of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 52|Participants were asked about their perception regarding any additional Osteoarthritis medications or treatments or any changes in regimen or dosages compared to their baseline (Day 0) state. Any change in the therapy (increased therapy, decrease therapy, no change in therapy) during the study was reported.|Baseline up to Week 52|ITT population. Number of participants analysed = participants with baseline and Week 52 data.|||participants|||Number
2581752|NCT02389452|Secondary|12-Item Short Form Health Survey (SF-12)|SF-12 health survey is a self-reported questionnaire to measure participant's profile of functional health and well-being. It includes following 12 questions (Q): Q1 In general, health status; Q2a Limitation of moderate activities; Q2b Limitation of climbing; Q3a Less accomplishment due to physical health; Q3b Limited in the kind of work or other activities due to physical health; Q4a Less accomplishment due to emotional problems; Q4b Did work or other activities less carefully than usual due to emotional problems; Q5 Pain interfere with normal work; Q6a Felt calm and peaceful; Q6b Had lot of energy; Q6c Felt downhearted and low; and Q7 Physical health or emotional problems interfered with social activities. Number of participants with response to each Q are reported.|Baseline, Week 26, 52|ITT population. Number of participants evaluable for baseline, Week 26 and Week 52 were 394, 394 and 388, respectively.|||participants|||Number
2581753|NCT02389452|Secondary|Clinician Observer Global Assessment (COGA) Score at Week 52|COGA (global self-assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by the physician to rate participant's osteoarthritis condition. Number of participants with different categories of PTGA score at Week 52 are reported.|Week 52 (missing data imputed by LOCF).|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.|||participants|||Number
2581754|NCT02389452|Secondary|Patient Global Assessment (PTGA) Score at Week 52|PTGA (global self-assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by participants to rate the osteoarthritis condition. Number of participants with different categories of PTGA score at Week 52 are reported.|Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.|||participants|||Number
2581755|NCT02389452|Secondary|Change From Baseline in WOMAC C Score at Week 52|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) calculated as a mean of 17 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.|Baseline, Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.|||units on a scale||Standard Deviation|Mean
2581756|NCT02389452|Secondary|Change From Baseline in WOMAC B Score at Week 52|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC B (measure of stiffness) calculated as a mean of 2 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of joint.|Baseline, Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.|||units on a scale||Standard Deviation|Mean
2581790|NCT02388880|Secondary|End-tidal Carbon Dioxide (EtCO2)|Change from baseline EtCO2 compared with the EtCO2 during use of the ITPR.|baseline to end of ITPR use||||mmHg||Standard Deviation|Mean
2581791|NCT02388880|Secondary|Intracranial Pressure (ICP)|Change from baseline ICP compared with the ICP during use of the ITPR.|baseline to end of ITPR use||||mmHg||Standard Deviation|Mean
2581757|NCT02389452|Secondary|Change From Baseline in WOMAC A Score at Week 52|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) calculated as a mean of 5 individual components, measured using a visual analogue scale (100 mm line marked by participants with score ranging from 0-100). Total score range is 0 to 100, where higher scores indicate higher pain.|Baseline, Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.|||units on a scale||Standard Deviation|Mean
2581758|NCT02389452|Secondary|Change From Baseline in WOMAC A1 Subscore at Week 52|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain.|Baseline, Week 52 (missing data imputed by LOCF)|ITT population. Number of participants analyzed=participants with baseline and Week 52 data.|||units on a scale||Standard Deviation|Mean
2581759|NCT02389452|Primary|Change From Baseline in WOMAC A1 Subscore at Week 26|WOMAC is health status measure questionnaire comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured using a visual analogue scale (100 mm line marked by participants with total score ranging from 0-100). Lower score represents lower pain.|Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF]).|ITT population.|||units on a scale||Standard Deviation|Mean
2581760|NCT02389374|Secondary|Frequency and Type of Variants of the G6PD Gene Within the Study Population||day 0 or 1||2019-12-31|12/2019||||
2581761|NCT02389374|Secondary|The Distribution of G6PD Activity Measured in U/gHb Among All Malaria Patients||day 0||||U/gHb||Inter-Quartile Range|Median
2581762|NCT02389374|Secondary|Proportion of Patients Adhering to 14 Days of Primaquine Treatment in the Vivax Cohort as Measured by Pill Count||day 16||||Participants|||Count of Participants
2581763|NCT02389374|Secondary|Recurrence of Parasitaemia Within 16 Days of Follow up||day 16||||Recurrences of Parsitaemia|||Number
2581764|NCT02389374|Secondary|Proportion of Patients With Fever on Day 2 After Treatment||day 2||||Participants|||Count of Participants
2581765|NCT02389374|Secondary|Proportion of Patients With Any Parasitemia on Day 3 After Treatment||day 3||||participants|||Number
2581766|NCT02389374|Secondary|Proportion of Patients With Anaemia Less Than 8g/dl on Day 2||on day 2||||participants with Hb under 8g/dl|||Number
2581767|NCT02389374|Secondary|Fractional Change in Hb Between Baseline and Day 9 and 16||day 0 and 16||||percent change Hb||95% Confidence Interval|Mean
2581768|NCT02389374|Secondary|Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl)||day 28||||participants|||Number
2581769|NCT02389374|Primary|The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment|The proportion of adverse and serious adverse events following unsupervised primaquine treatment until day 28|during follow up (day 28)||||events|||Number
2581770|NCT02389361|Primary|Acute Pain|Difference between groups in term of analgesia (as measured by Visual Analog Scale: VAS). The VAS range are between 0 and 10. A worse outcome was defined as VAS > 4. The VAS use units on a scale.|In recovery room||||units on a scale||Standard Deviation|Median
2581771|NCT02389101|Primary|68Ga-DOTANOC Uptake in Lymphomas With PET/CT|Uptake of 68Ga-DOTANOC in lymphoma expressed as SUVmax|Within 30 days prior to start of chemotherapy|Lesion with highest radioactivity|||Standardized Uptake Value|Lymphomatous lesion|Full Range|Median
2581772|NCT02389088|Primary|Testosterone, Androstenedione and 17-OH Progesterone During Phase I and Phase II|Testosterone, Androstenedione and 17-OH Progesterone (nmol/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.|At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase II|Phase I and Phase II - PCOS patients.|||nmol/L||Standard Deviation|Mean
2581773|NCT02389088|Primary|LH and FSH During Phase I and Phase II|LH and FSH (IU/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.|At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase II|Phase I and Phase II - PCOS patients.|||IU/L||Standard Deviation|Mean
2581774|NCT02389088|Primary|Inhibin B During Phase I and Phase II|Inhibin B (ng/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.|At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase II|Phase I and Phase II - PCOS patients.|||ng/L||Standard Deviation|Mean
2581775|NCT02389088|Primary|Estradiol During Phase I and Phase II|Estradiol (pmol/L) measured during Phase I (without Letrozole) and during Phase II (with Letrozole) at time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation.|At time 24 hours during Week 0 and times 0 and 24 hours during Weeks 5 and 6 after FSH stimulation for both Phase I and Phase II|Phase I and Phase II - PCOS patients.|||pmol/L||Standard Deviation|Mean
2581776|NCT02388997|Post-Hoc|Time to Peak Airway Symptoms (Lower Respiratory Tract) Following Virus Inoculation.|Time to peak airway symptoms (lower respiratory tract) following virus inoculation was compared among the asthmatics in the omalizumab treatment arm compared to time to peak symptoms among those in the placebo treatment arm.|21 days|Two participants in the mild asthmatics treated with omalizumab treatment arm had to be dropped according to protocol because one developed a positive qPCR test for rhinovirus (the virus used for inoculation) 4 weeks before virus inoculation, and the other developed a positive qPCR test for rhinovirus during the week before inoculation.|||days||95% Confidence Interval|Geometric Mean
2581777|NCT02388997|Secondary|Number of Participants Whose FEV1 Dropped by More Than 20% During the Infection.|Number of participants whose FEV1 dropped by more than 20% during the infection compared to their FEV1 value at baseline at the time of enrollment.|21 days|Two participants in the omalizumab treatment arm had to be dropped according to protocol because 1 developed a positive qPCR test for rhinovirus 4 weeks before virus inoculation, and the other developed a positive qPCR test for rhinovirus during the week before inoculation.|||Participants|||Count of Participants
2581778|NCT02388997|Secondary|Airway Symptom Scores Experienced by Participants During the First 4 Days of the Acute Infection (Upper Respiratory Tract Symptoms).|This secondary outcome was based on the comparison of cumulative upper respiratory tract symptoms scores (CURTS) in the asthmatic subjects treated with omalizumab compared to those treated with placebo over the first 4 days of acute infection. The symptoms evaluated daily included runny nose, sneezing, nasal congestion, sore throat, headache, chills/fever, fatigue, itchy/watery eyes. Symptom scores were recorded by subjects twice daily (in the morning and evening). Each symptom was scored on a scale of 1 to 3. Therefore, the total maximum (worst) score for a day would be 48. The scores recorded daily could range from 0 to 48.|4 days|Two participants in the mild asthmatics treated with omalizumab treatment arm had to be dropped according to protocol because one developed a positive qPCR test for rhinovirus (the virus used for inoculation) 4 weeks before virus inoculation, and the other developed a positive qPCR test for rhinovirus during the week before inoculation.|||units on a scale||95% Confidence Interval|Mean
2581779|NCT02388997|Secondary|Airway Symptom Scores Experienced by Participants During the First 4 Days of the Acute Infection With Cough.|This secondary outcome was based on the comparison of cumulative lower respiratory tract symptoms scores (CLRTS) in the asthmatic subjects treated with omalizumab compared to those treated with placebo over the first 4 days of acute infection. The symptoms evaluated daily included wheeze, chest tightness, shortness of breath and cough. Symptom scores were recorded by subjects twice daily (in the morning and evening). Each symptom was scored on a scale of 1 to 3. Therefore, the total maximum (worst) score for a day would be 24. The scores recorded daily could range from 0 to 24.|4 days|Two participants in the mild asthmatics treated with omalizumab treatment arm had to be dropped according to protocol because one developed a positive qPCR test for rhinovirus (the virus used for inoculation) 4 weeks before virus inoculation, and the other developed a positive qPCR test for rhinovirus during the week before inoculation.|||units on a scale||95% Confidence Interval|Mean
2581780|NCT02388997|Secondary|Airway Symptom Scores Experienced by Participants During the 21 Days of Monitoring During the Infection.|This secondary outcome was based on the comparison of cumulative lower respiratory tract symptoms scores (CLRTS) in the asthmatic subjects treated with omalizumab compared to those treated with placebo over the 21 days of monitoring during the infection. The symptoms evaluated daily included wheeze, chest tightness, and shortness of breath. Symptom scores were recorded by subjects twice daily (in the morning and evening). Each symptom was scored on a scale of 1 to 3. Therefore, the total maximum (worst) score for a day would be 18. The scores recorded daily could range from 0 to 18.|21 days|Two participants in the mild asthmatics treated with omalizumab treatment arm had to be dropped according to protocol because one developed a positive qPCR test for rhinovirus (the virus used for inoculation) 4 weeks before virus inoculation, and the other developed a positive qPCR test for rhinovirus during the week before inoculation.|||units on a scale||95% Confidence Interval|Mean
2581781|NCT02388997|Secondary|Airway Symptom Scores Experienced by Participants During the First 7 Days of the Acute Infection.|This secondary outcome was based on the comparison of cumulative lower respiratory tract symptoms scores (CLRTS) in the asthmatic subjects treated with omalizumab compared to those treated with placebo over the first 7 days of acute infection. The symptoms evaluated daily included wheeze, chest tightness, and shortness of breath. Symptom scores were recorded by subjects twice daily (in the morning and evening). Each symptom was scored on a scale of 1 to 3. Therefore, the total maximum (worst) score for a day would be 18. The scores recorded daily could range from 0 to 18.|7 days|Two participants in the mild asthmatics treated with omalizumab treatment arm had to be dropped according to protocol because one developed a positive qPCR test for rhinovirus (the virus used for inoculation) 4 weeks before virus inoculation, and the other developed a positive qPCR test for rhinovirus during the week before inoculation.|||units on a scale||95% Confidence Interval|Mean
2581782|NCT02388997|Primary|Airway Symptom Scores Experienced by Participants During the First 4 Days of the Acute Infection.|The primary outcome was based on the comparison of cumulative lower respiratory tract symptoms scores (CLRTS) in the asthmatic subjects treated with omalizumab compared to those treated with placebo over the first 4 days of acute infection. The symptoms evaluated daily included wheeze, chest tightness, and shortness of breath. Symptom scores were recorded by subjects twice daily (in the morning and evening). Each symptom was scored on a scale of 1 to 3. Therefore, the total maximum (worst) score for a day would be 18. The scores recorded daily could range from 0 to 18.|4 days|Two participants in the mild asthmatics treated with omalizumab treatment arm had to be dropped according to protocol because one developed a positive qPCR test for rhinovirus (the virus used for inoculation) 4 weeks before virus inoculation, and the other developed a positive qPCR test for rhinovirus during the week before inoculation.|||units on a scale||95% Confidence Interval|Mean
2581783|NCT02388932|Secondary|Quality of Life Assessed by Functional Assessment of Cancer Therapy-Head and Neck Questionnaire|Repeated analysis of variance measures will be used to analyze the quality of life data.|Up to 12 months|No patient was able to complete 3 month follow up to provide this QOL information||||||
2581784|NCT02388932|Secondary|Incidence of SBRT Related Morbidity|Number of patients who experiences SBRT-related morbidity according to NCI CTCAE v 4.0|Up to 12 months|Patients who were eligible for evaluation for SBRT-related morbidity incidence|||Participants|||Count of Participants
2581785|NCT02388932|Secondary|Response Measured According to Standard Response Evaluation Criteria in Solid Tumors|Trend tests will be used to investigate the relationship between SBRT dose and response.|Up to 12 months|There was insufficient patient accrual to perform additional statistical analysis.||||||
2581786|NCT02388932|Secondary|Local Progression Free Survival|Kaplan-Meier estimates will be used to plot local progression free survival.|Up to 12 months|No patients were alive at 12 months, so no analysis was done.||||||
2581787|NCT02388932|Secondary|Overall Survival|Kaplan-Meier estimates will be used to plot overall survival - the number of patients alive at 12 months followup|Up to 12 months|Patients who went on study|||Participants|||Count of Participants
2581788|NCT02388932|Primary|Incidence of Dose Limiting Toxicities (DLTs)|Number of patients with dose limiting toxicity events graded according to CTCAE Version 4.0|3 months from start of treatment|Participants who enrolled in study and were treated.|||Participants|||Number
2581792|NCT02388880|Secondary|Mean Arterial Pressure (MAP)|Change from baseline MAP compared with the MAP during use of the ITPR.|baseline to end of ITPR use||||mmHg||Standard Deviation|Mean
2581794|NCT02388815|Primary|Point Accuracy|"Point accuracy of Sensor based glucose values versus fingerstick blood glucose determined as % within Consensus Error Grid zone A.~The Consensus Error Grid was developed from a survey of 100 clinicians to evaluate the accuracy of glucose measurements. Glucose results from the system under test (y) are paired with those from a reference method (x) and each (x,y) point is plotted on a grid. The grid has 5 risk categories, assigned by the clinicians surveyed. Risk categories (in order of increasing severity) are: Zone A: no effect on clinical action; Zone B: altered clinical action or little or no effect on clinical outcome; Zone C: altered clinical action likely to effect clinical outcome; Zone D: altered clinical action, could have significant medical risk; Zone E: altered clinical action, could have dangerous consequences.~Result were calculated for all subjects ie total number of sensor results and fingerstick blood glucose results divided by the total number of results x 100."|14 days|One subject withdrew prior to having a sensor applied, another did not perform any blood glucose tests on the FreeStyle Libre. Neither subject could be included in the accuracy analysis, both are included in the safety analysis.|||percentage of glucose results in zone A||95% Confidence Interval|Number
2581795|NCT02388776|Secondary|Predictive Value of ROTEM Data|To assess whether ROTEM abnormalities correlate with allogenic blood product administration by blinded ICU physicians|21 days|Only two subjects enrolled, one withdrawn early due to death and the second lost to follow up prior to the completion of the final ROTEM testing.||||||
2581796|NCT02388776|Primary|Coagulation Parameters|To compare ROTEM coagulation parameters involving fibrin contribution to clot formation (FIBTEM) between patients on admission/enrollment (day 1), and on days 2, 3, 5, 7, 14 and 21 after burn injury to see if expected hypercoagulability shows evidence of resolution.|21 days|Data not collected for two subjects for all time points for primary outcome due to subject being discharged from hospital and subject death.||||||
2581797|NCT02388763|Secondary|High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10|High contrast TCVA was assessed after 3 hours exposure to normal environment and prior to exposure to reduced humidity environment. Both eyes contributed to the analysis.|Day 10, each product|Intent to Treat Subjects|||VA unit||Standard Deviation|Mean
2581798|NCT02388763|Primary|High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10|High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.|Day 10, each product|Intent to Treat|||VA unit||Standard Deviation|Mean
2581799|NCT02388737|Secondary|Change From Baseline in Serum Pepsinogen II||Baseline and Weeks 4, 12 and 24|Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase.The number analyzed is the number of participants with data available for analysis.|||ug/L||Standard Deviation|Mean
2581800|NCT02388737|Secondary|Change From Baseline in Serum Pepsinogen I||Baseline and Weeks 4, 12 and 24|Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase. The number analyzed is the number of participants with data available for analysis.|||ug/L||Standard Deviation|Mean
2581801|NCT02388737|Secondary|Change From Baseline in Serum Gastrin||Baseline and Weeks 4, 12 and 24|Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase. The number analyzed is the number of participants with data available for analysis.|||pmol/L||Standard Deviation|Mean
2581802|NCT02388737|Secondary|Number of Participants With Abnormal Vital Sign Measurements|The percentage of participants with any markedly abnormal vital sign measurements including (body temperature, blood pressure and pulse), mmHg = millimeters of mercury.|From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)|Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase. The number analyzed is the number of participants with data available for analysis.|||Participants|||Count of Participants
2581803|NCT02388737|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Number of participants with any markedly abnormal 12-lead ECG findings is reported. bpm = beats per minute, msec = milliseconds, CHG= change from baseline.|From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)|Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase. The number analyzed is the number of participants with data available for analysis.|||Participants|||Count of Participants
2581804|NCT02388737|Secondary|Number of Participants With Abnormal Clinical Laboratory Findings|Clinical laboratory safety tests included chemistry, hematology and urinalysis. Number of participants with any markedly abnormal values in laboratory tests collected throughout study is reported. ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma-glutamyl transferase, CPK = creatine phosphokinase, BUN = blood urea nitrogen, LLN = lower limit of normal or lower reference limit, ULN = upper limit of normal or upper reference limit, g/L = grams per liter, U/L = units per liter, mmol/L = millimoles per liter, pmol/L = picomoles per liter.|From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)|Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase. The number analyzed is the number of participants with data available for analysis.|||Participants|||Count of Participants
2581805|NCT02388737|Secondary|Number of Participants With Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug.|From Day 1 to 14 days after the last dose of study medication (up to 26 weeks)|Safety analysis set included all participants who took at least 1 dose of the Maintenance Phase drug and was based on the treatment received in the Maintenance Phase.|||Participants|||Count of Participants
2581806|NCT02388737|Secondary|Percentage of Participants With Recurrence of Erosive Esophagitis After 12 Weeks of Treatment in the Maintenance Phase|Erosive esophagitis recurrence is defined as endoscopically confirmed to have erosive esophagitis (LA classification grades A to D) during the Maintenance Phase (12 weeks). Grade A: >/=1 mucosal breaks </=5 mm, none of which extends between the tops of the mucosal folds; Grade B: >/=1 mucosal breaks >5 mm, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve <75% of esophageal circumference; Grade D: mucosal breaks which involve >/=75% of esophageal circumference.|12 weeks|Full analysis set included all randomized participants who received at least 1 dose of the Maintenance Phase drug and had at least 1 post-baseline endoscopy, and was based on randomized treatment.|||percentage of participants||95% Confidence Interval|Number
2581807|NCT02388737|Primary|Percentage of Participants With Recurrence of Erosive Esophagitis as Confirmed on Endoscopy After the 24-week Maintenance Phase|Erosive esophagitis recurrence is defined as participants endoscopically confirmed to have erosive esophagitis (Los Angeles [LA] classification grades A to D) during the Maintenance Phase (24 weeks). Grade A: >/=1 mucosal breaks </=5 mm, none of which extends between the tops of the mucosal folds; Grade B: >/=1 mucosal breaks >5 mm, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve <75% of esophageal circumference; Grade D: mucosal breaks which involve >/=75% of esophageal circumference.|24 weeks|Full analysis set included all randomized participants who received at least 1 dose of the Maintenance Phase drug and had at least 1 post-baseline endoscopy, and was based on randomized treatment.|||percentage of participants||95% Confidence Interval|Number
2581808|NCT02388724|Secondary|Change From Baseline in Serum Pepsinogen II|The change between the serum pepsinogen II values collected at Weeks 2, 4, and 8 relative to baseline.|Baseline and Weeks 2, 4, and 8|The safety analysis set (SAF) included all participants who took at least 1 dose of study medication. The number analyzed is the number of participants with data available for analysis.|||ug/L||Standard Deviation|Mean
2581809|NCT02388724|Secondary|Change From Baseline in Serum Pepsinogen I|The change between the serum pepsinogen I values collected at Weeks 2, 4, and 8 relative to baseline.|Baseline and Weeks 2, 4, and 8|The safety analysis set (SAF) included all participants who took at least 1 dose of study medication. The number analyzed is the number of participants with data available for analysis.|||micrograms per liter (ug/L)||Standard Deviation|Mean
2581810|NCT02388724|Secondary|Change From Baseline in Serum Gastrin|The change between the serum gastrin values collected at Weeks 2, 4, and 8 relative to baseline.|Baseline and Weeks 2, 4, and 8|The safety analysis set (SAF) included all participants who took at least 1 dose of study medication. The number analyzed is the number of participants with data available for analysis.|||pmol/L||Standard Deviation|Mean
2581811|NCT02388724|Secondary|Number of Participants With Markedly Abnormal Vital Sign Measurements|Number of participants with any markedly abnormal vital signs measurements is reported. Vital signs included body temperature (oral, tympanic, or infra-axillary measurement), sitting blood pressure (5 minutes), and pulse. °C = degrees Celsius, mmHg = millimeters of mercury, bpm = beats per minute.|From Day 1 to 14 days after the last dose of study medication (up to 10 weeks)|The safety analysis set (SAF) included all participants who took at least 1 dose of study medication. The number analyzed is the number of participants with data available for analysis.|||Participants|||Count of Participants
2581812|NCT02388724|Secondary|Number of Participants With Markedly Abnormal Electrocardiogram (ECG) Findings|Number of participants with any markedly abnormal 12-lead ECG findings is reported. bpm = beats per minute, msec = milliseconds, CHG= change from baseline.|From Day 1 to 14 days after the last dose of study medication (up to 10 weeks)|The safety analysis set (SAF) included all participants who took at least 1 dose of study medication. The number analyzed is the number of participants with data available for analysis.|||Participants|||Count of Participants
2581813|NCT02388724|Secondary|Number of Participants With Markedly Abnormal Clinical Laboratory Findings|Clinical Laboratory Safety tests included Chemistry, Hematology and Urinalysis. Number of participants with any markedly abnormal values in laboratory tests collected throughout study is reported. ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma-glutamyl transferase, CPK = creatine phosphokinase, BUN = blood urea nitrogen, LLN = lower limit of normal or lower reference limit, ULN = upper limit of normal or upper reference limit, g/L = grams per liter, U/L = units per liter, mmol/L = millimoles per liter, pmol/L = picomoles per liter.|From Day 1 to 14 days after the last dose of study medication (up to 10 weeks)|The safety analysis set (SAF) included all participants who took at least 1 dose of study medication. The number analyzed is the number of participants with data available for analysis.|||Participants|||Count of Participants
2581814|NCT02388724|Secondary|Number of Participants Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug.|On or after the start of study drug (Day 1) to 14 days after the last dose of study medication (up to 10 weeks)|The safety analysis set (SAF) included all participants who took at least 1 dose of study medication.|||Participants|||Count of Participants
2581815|NCT02388724|Secondary|Percentage of Participants With Endoscopic Healing of Erosive Esophagitis After 2 Weeks and 4 Weeks of Treatment|Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification grade O during the treatment phase. Grade O indicates there are no mucosal breaks in the mucosa.|Week 2 and Week 4|The full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline endoscopy. Number analyzed is the number of participants with data available at the given time-point.|||percentage of participants||95% Confidence Interval|Number
2581816|NCT02388724|Primary|Percentage of Participants With Endoscopic Healing of Erosive Esophagitis During the 8-Week Treatment Phase|Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification grade O during the treatment phase. Grade O indicates there are no mucosal breaks in the mucosa.|8 weeks|The full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline endoscopy.|||percentage of participants||95% Confidence Interval|Number
2581821|NCT02388568|Primary|Proportion Maintaining >= 5% Loss of Initial Weight|This is the number of participants who maintained >=5% loss of initial weight in the randomization to week 52 trial period.|52 weeks post-randomization||||Participants|||Count of Participants
2581822|NCT02388568|Primary|Change in Weight (kg)|This is the change in weight from randomization to week 52. This does not include the weight loss in the 14-week LCD.|52 weeks post-randomization||||kg||Standard Error|Mean
2581823|NCT02388347|Secondary|Percentage of Participants Positive for Anti-Drug Antibodies to MEDI7836|A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.|Predose on Day 1 to 281 days Postdose|"As Treated Population included all randomized participants and treated with MEDI7836 or placebo. Here, n is number of participants analysed at given time point."|||Percentage of participant|||Number
2581824|NCT02388347|Secondary|Apparent Terminal-Phase Volume of Distribution (Vz/F) of MEDI7836|The apparent volume of distribution of MEDI7836 after a single dose, calculated according to the equation: Vz/F = Apparent total clearance (CL/F) / terminal phase rate constant (λz).|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.|||mL||Standard Deviation|Mean
2581825|NCT02388347|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI7836|The Tmax is defined as actual sampling time to reach maximum observed MEDI7836 concentration.|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.|||day||Full Range|Median
2581826|NCT02388347|Secondary|Terminal Phase Elimination Half Life (T1/2) of MEDI7836|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.|||day||Standard Deviation|Mean
2581827|NCT02388347|Secondary|Apparent Systemic Clearance (CL/F) of MEDI7836|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.|||milliliter per day (mL/day)||Standard Deviation|Mean
2581828|NCT02388347|Secondary|Maximum Observed Serum Concentration (Cmax) of MEDI7836|The Cmax is the maximum observed serum concentration of study drug.|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2581829|NCT02388347|Secondary|Area Under the Concentration-Time Curve From Zero to Last Observation (AUC [0-t]) of MEDI7836|Area under the concentration-time curve of the MEDI7836 in serum over the time interval from 0 to the last quantifiable data point (AUC0-t).|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|PK Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.|||day*mcg/mL||Standard Deviation|Mean
2581830|NCT02388347|Secondary|Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI7836|Area under the concentration-time curve of the MEDI7836 in serum over the time interval from 0 extrapolated to infinity (AUC0-inf).|Predose on Day 1 and on Days 2, 3, 4, 6, 8, 10, 15, 29, 43, 57, 85, 113, 169, 225 and 281 Postdose|Pharmacokinetic (PK) Population included all participants who received MEDI7836 had detectable postdose MEDI7836 serum concentrations.|||Day*microgram per milliliter||Standard Deviation|Mean
2581831|NCT02388347|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events|AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS, QT and QTc intervals. Treatment-emergent adverse events between administration of investigational product and Day 281 that were absent before treatment or that worsened relative to pre-treatment state.|From Study Drug Administration to 281 Days Postdose|As Treated Population included all randomized participants and treated with MEDI7836 or placebo.|||Participant|||Number
2581832|NCT02388347|Primary|Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment-Emergent Adverse Events|Vital sign parameters included blood pressure, temperature, pulse rate, respiratory rate and weight. Physical examination included assessment of general appearance, weight, head, ears, eyes, nose, throat, neck, skin, cardiovascular system, respiratory system, abdominal system, and nervous system. Criteria for abnormal physical findings was based on investigator's discretion. TEAEs were present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug until Day 281 after the last dose of study drug.|From Study Drug Administration to 281 Days Postdose|As Treated Population included all randomized participants and treated with MEDI7836 or placebo.|||Participant|||Number
2581833|NCT02388347|Primary|Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between first dose of study drug and Day 281 after the last dose that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.|From Study Drug Administration to 281 Days Postdose|As Treated Population included all randomized participants and treated with MEDI7836 or placebo.|||Participant|||Number
2581834|NCT02388347|Primary|Number of Participants With Injection Site Reactions|Participants were evaluated for manifestations of injection site reactions.|From Study Drug Administration to 281 Days Postdose|As Treated Population included all randomized participants and treated with MEDI7836 or placebo.|||Participant|||Number
2581904|NCT02387749|Primary|Change of Nerve Conduction Amplitude of Nerves Affected Measured by Nerve Conduction Study.|"Measuring nerve conduction amplitudes in uv of upper and lower limbs nerves(sensory and motor).~lower limb nerves : tibial , common peroneal(CP) as motor and sural nerve as sensory .~upper limb nerves: ulnar nerve as motor and sensory. and compare at base line and 90 days after stem cells transfusion"|base line(zero dya), 90 days after stem cells transfusion||||uv||Standard Deviation|Mean
2581835|NCT02388347|Primary|Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received MEDI7836. Treatment-emergent adverse events between administration of investigational product and Day 281 that were absent before treatment or that worsened relative to pretreatment state.|From Study Drug Administration to 281 Days Postdose|As Treated Population included all randomized participants and treated with MEDI7836 or placebo.|||Participant|||Number
2581836|NCT02388321|Secondary|Adverse Events at 30 Minutes|The patient were asked at 30 minutes post administration of analgesia if they experienced any side effects like nausea, vomiting, headache etc.|30 minutes||||Participants|||Count of Participants
2581837|NCT02388321|Primary|Pain Score at 30 Minutes|An 11 point Likert Visual Analog Scale with 0 being no pain, 5 being moderate pain and 10 being very severe pain was verbally administered to the patient at 30 minutes post administration of analgesia.|30 minutes||||units on a scale||Standard Deviation|Mean
2581838|NCT02388295|Other Pre-specified|Exploratory Efficacy: Unified Multiple System Atropy Rating Scale, Change From Baseline (Total Score, Part 1 + Part 2)|Exploratory efficacy: Unified Multiple System Atropy Rating Scale, change from baseline (total Score, Part 1 + Part 2) : Score range 0 to 104, positive value indicates worsening symptoms|Baseline to final treatment visit|Efficacy population: with baseline (Day -1) and post baseline assessment|||Score change from baseline||90% Confidence Interval|Least Squares Mean
2581839|NCT02388295|Secondary|Myeloperoxidase (MPO) Inhibition in Plasma (Change From Baseline), Specific Activity|Myeloperoxidase (MPO) inhibition in plasma (change from baseline), on samples collected and analyzed, specific activity (activity/protein)|Baseline (Day -1) and week 12|efficacy population, restricted to subjects with paired samples analyzed within 6 months of collection|||ratio||90% Confidence Interval|Least Squares Mean
2581840|NCT02388295|Primary|Striatum Brain Region: Change From Baseline in Microglia Activation Via Positron Emission Tomography(PET)|Striatum Brain region: Change from baseline in microglia activation via PET By [11C]PBR28 binding to translocator protein|Baseline (pre randomization) and Week 12|PET analysis population (Paired baseline and week 12 PET scans)|||ml/cc||Standard Deviation|Mean
2581841|NCT02388269|Secondary|Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)|"Short-Form Leeds Dyspepsia Questionnaire (SFLDQ): Question 5: Most Troublesome Symptom.~In question five of the SFLDQ the subject reports which of the symptoms has been most troublesome to them, this is also reported for each of the study periods. (Note: results of questions 1-4 of the SFLDQ are reported separately in outcome measure 3.)"|Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period||||Participants|||Count of Participants
2581842|NCT02388269|Secondary|Number of Participants With Adverse Events|Summary of Treatment Emergent Adverse Events. Subjects were monitored for occurrence of adverse events from the start of the run-in period to the end of the open label period..|Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period|Safety Population|||Participants|||Count of Participants
2581843|NCT02388269|Secondary|Symptom Change at 8 Weeks Compared to 4 Weeks (GOS Dyspepsia or IBS Severity Scoring System)|Global Overall Symptom (GOS) scale is self-reported. Patients grade overall severity of dyspepsia symptoms over a retrospective period of time. The scale uses a 7-point Likert scale ranging from minimum 1 = no problem to maximum 7 = very severe problem. Subjects assess how their stomach problems have been over the specific time period, and indicate severity of symptoms for 10 specific upper GI symptoms (epigastric pain, epigastric discomfort, heartburn, acid regurgitation, upper abdominal bloating, excessive belching, nausea, early satiety, postprandial fullness, other epigastric symptoms). Total minimum = 10 and total maximum = 70. The Irritable Bowel Syndrome Score (IBS) measures severity of symptoms by 5 questions: abdominal pain, number days with pain in every 10 days (multiplied by 10), abdominal distension, bowel movement satisfaction, interference with general life. Each question scores from 0 (not severe) to 100 (severe). Total score: Min = 0 healthy; Max = 500 severely sick.|Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period|Intention To Treat (ITT)|||units on a scale||Standard Deviation|Mean
2581844|NCT02388269|Secondary|Use of Concomitant Medication (Intake and Dose) During the Course of the Study|Compare last 2 weeks in randomised period with the run-in period, comparison open label period to randomization period. Concomitant medications were recorded and the number of subjects taking one or more concomitant medications is compared in the active and shams groups for both Functional Dyspepsia and Irritable Bowel Syndrome cohorts during the run-in, randomized and open label periods.|Run-In (2 weeks) and Randomized (4 weeks)|Intent-to-Treat|||Participants|||Count of Participants
2581845|NCT02388269|Secondary|Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)|Compare last 2 weeks in randomized period with the run-in period; & compare open label period to randomization period using Short-Form Dyspepsia Questionnaire (SFLDQ).The SFLDQ is a validated, self-completed questionnaire that measures frequency and severity of dyspepsia. The questionnaire comprises of 5 questions, questions 1 to 4 are about the patients dyspeptic symptoms and question 5 is about the most troublesome symptom for the patient. Questions 1 to 4 comprise of two stems concerning 'frequency' (how often the subject has the symptom over the last 2 months) and 'severity' (how often has this symptom interfered with normal activities over the last 2 months). Subjects choose from: Not at all, less than monthly, between monthly & weekly, between weekly & daily, more than daily or no response. In question 5 the subject reports which symptoms has been most troublesome for each of the study periods. Results for Question 5 of the SFLDQ are reported separately in outcome measure 7.|Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period|Intention to Treat|||Participants|||Count of Participants
2581905|NCT02387749|Primary|Change of Nerve Conduction Latency of Nerves Affected Measured by Nerve Conduction Study|Measuring nerve conduction latency in msec of upper and lower limbs nerves(sensory and motor) lower limb nerves : tibial , common peroneal(CP) as motor and sural nerve as sensory upper limb nerves: ulnar nerve as motor and sensory and compare at base line and 90 days after stem cells transfusion|base line(zero dya), 90 days after stem cells transfusion .||||msec||Standard Deviation|Mean
2581846|NCT02388269|Secondary|Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)|"Compare Quality of Life in last 2 weeks in the randomized period with the run-in period, and compare of Quality of life in the open label period to randomization period using the Functional Digestive Disorder Quality of Life (FDDQL) questionnaire.~The Functional Digestive Disorder Quality of Life (FDDQL) questionnaire is designed to measure Quality of Like (QOL) in patients with Functional Dyspepsia (FD) or Irritable Bowel Syndrome (IBS). The questionnaire is composed of 43 items (questions) investigating 8 dimensions: Daily activities, Anxiety, Diet, Sleep, Discomfort, Health, Coping and Stress. For the 43 items, patients rate the impact of their condition over the 8 dimensions from 1-5, where 1 = Not at all, 2 = A little Bit, 3 = Moderately, 4= Quite a bit, and 5 = Extremely. The mean score of the 8 dimensions is shown in the outcome measure data table."|Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) period|Intention To Treat population (ITT)|||units on a scale||Standard Deviation|Mean
2581847|NCT02388269|Primary|Symptom Changes in Subjects With Functional Gastrointestinal Disorder (Functional Dyspepsia and Irritable Bowel Syndrome)|Global Overall Symptom (GOS) scale is self-reported. Patients grade overall severity of dyspepsia symptoms over a retrospective period of time. The scale uses a 7-point Likert scale ranging from minimum 1 = no problem to maximum 7 = very severe problem. Subjects assess how their stomach problems have been over the specific time period, and indicate severity of symptoms for 10 specific upper GI symptoms (epigastric pain, epigastric discomfort, heartburn, acid regurgitation, upper abdominal bloating, excessive belching, nausea, early satiety, postprandial fullness, other epigastric symptoms). Total minimum = 10 and total maximum = 70. The Irritable Bowel Syndrome Score (IBS) measures severity of symptoms by 5 questions: abdominal pain, number days with pain in every 10 days (multiplied by 10), abdominal distension, bowel movement satisfaction, interference with general life. Each question scores from 0 (not severe) to 100 (severe). Total score: Min = 0 healthy; Max = 500 severely sick.|Last 2 weeks in the 4 week Randomized period|Intention To Treat population (ITT)|||units on a scale||Standard Deviation|Mean
2581848|NCT02388191|Secondary|Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)|"Pain 15 minutes after IUD insertion will occur 15 minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure."|Fifteen minutes after IUD insertion is complete||||units on a scale||Inter-Quartile Range|Median
2581849|NCT02388191|Secondary|Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)|"Pain 5 minutes after IUD insertion will occur five minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure."|Five minutes after IUD insertion is complete||||units on a scale||Inter-Quartile Range|Median
2581850|NCT02388191|Secondary|Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS)|"Pain with uterine sounding will be measured immediately after uterine sounding using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure."|Immediately after uterine sounding||||units on a scale||Inter-Quartile Range|Median
2581851|NCT02388191|Secondary|Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS)|"Pain with tenaculum placement will be measured immediately after tenaculum is placed on the cervix using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure."|Immediately after tenaculum is placed on cervix||||units on a scale||Inter-Quartile Range|Median
2581852|NCT02388191|Primary|Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS)|"Pain at time of IUD insertion will be measured immediately upon completion of IUD insertion using a 100 mm visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is 0 = No pain. On the opposite end of the line, the anchor is 10 = worst pain possible. Subjects are asked: Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below. Research staff measure the distance between the 0 = No pain anchor and the mark made by the patient (in mm) to score the measure."|Immediately after IUD insertion is complete||||units on a scale||Inter-Quartile Range|Median
2581853|NCT02388074|Primary|Number of Red Fluorescent [i.e., Cancer] Cells (RFCs) in Sputum From Healthy Participants|"The presence or absence of red fluorescent (RFCs) cancer cells was evaluated in sputum samples from healthy individuals labeled with CyPath®.~Testing for the study was performed at one study center to collect sputum samples from healthy individuals who have no known lung disease. Comparison of sputum specimens from one cohort of Participants who are healthy with two additional cohorts of Participants, including individuals at high risk for lung cancer and individuals diagnosed with lung cancer, that has already been completed."|2 months|22 participants were evaluated by a cytopathologist. Of these 22, PAP-stained slides of 3 participants were unreadable, 14 participants had provided samples that were confirmed by PAP as inadequate and only 5 slides were confirmed by PAP as adequate deep lung sputum samples. These 5 samples were evaluated for the presence of RFCs.|||number of RFCs per participant||Standard Deviation|Mean
2581928|NCT02387476|Secondary|Wakefulness (Min)|Measure of time not sleeping (minutes)|per night|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||minutes||Standard Deviation|Mean
2581854|NCT02387996|Secondary|ORR Per Investigator by PD-L1 Expression Level|Investigator-assessed ORR was defined as the number of subjects with a best overall response of confirmed CR or PR divided by the number of all treated subjects. PD-L1 expression level = Membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category|from the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.|||Percent of Participants||95% Confidence Interval|Number
2581855|NCT02387996|Secondary|Objective Response Rate (ORR) Per Investigator|Investigator-assessed ORR was defined as the number of subjects with a best overall response of confirmed CR or PR divided by the number of all treated subjects.|from the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.|||Percent of Participants||95% Confidence Interval|Number
2581856|NCT02387996|Secondary|OS by PD-L1 Expression Level|Overall Survival was defined as the time from first dosing date to the date of death. A subject who had not died was censored at last known date alive. PD-L1 expression level = membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category|From first dosing date to the date of death (approximately 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.|||Months||95% Confidence Interval|Median
2581857|NCT02387996|Secondary|Overall Survival|Overall Survival was defined as the time from first dosing date to the date of death. A subject who had not died was censored at last known date alive.|From first dosing date to the date of death (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.|||months||95% Confidence Interval|Median
2581858|NCT02387996|Secondary|PFS Per BIRC Assessment by PD-L1 Expression Level|PFS was defined as the time from first dosing date to the date of the first documented tumor progression, based on BIRC assessments (per RECIST 1.1), or death due to any cause. RECIST is the Response Evaluation Criteria in Solid Tumors PD-L1 expression level is defined as membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category|from first dosing date to the date of the first documented tumor progression (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.|||months||95% Confidence Interval|Median
2581859|NCT02387996|Secondary|Progression-Free Survival (PFS) Per BIRC Assessment|PFS was defined as the time from first dosing date to the date of the first documented tumor progression, based on BIRC assessments (per RECIST 1.1), or death due to any cause. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. RECIST = Response Evaluation Criteria in Solid Tumors|from first dosing date to the date of the first documented tumor progression (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.|||Months||95% Confidence Interval|Median
2581860|NCT02387996|Primary|ORR Per BIRC Assessment by PD-L1 Expression Level|Objective Response Rate (ORR) was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. BIRC= blinded independent review committee PD-L1 expression level= membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category|From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.|||Percent of Participants||95% Confidence Interval|Number
2581861|NCT02387996|Primary|Objective Response Rate Per BIRC Assessment|Objective Response Rate (ORR) was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. BIRC= blinded independent review committee|From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)|All treated participants. Treated participants from Japan enrolled after main enrollment period were excluded from primary efficacy analysis.|||Percent of participants||95% Confidence Interval|Number
2581862|NCT02387983|Primary|Tmax of Posaconazole on Day 1|The Tmax was calculated in order to determine the time required to reach Cmax in the Immediate and Sparse PK subgroup on Day 1.|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1|The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.|||Hours||Full Range|Median
2581863|NCT02387983|Primary|Cmin of Posaconazole on Day 1|The Cmin was calculated in order to determine the lowest measurable drug concentration from immediately after dosing to 24 hours post-dose in the Immediate and Sparse PK subgroup on Day 1. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1|The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.|||ng/mL||Standard Deviation|Mean
2581864|NCT02387983|Primary|Cmax of Posaconazole on Day 1|The Cmax was calculated to determine the maximum plasma drug concentration up to 24 hours post-dose in the Immediate and Sparse PK subgroup on Day 1. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1|The PK analysis set included all randomized and treated participants in the Immediate and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.|||ng/mL||Standard Deviation|Mean
2581865|NCT02387983|Primary|AUC0-24hr of Posaconazole on Day 1|The AUC0-24hr was calculated to determine the mean plasma drug concentration from immediately after dosing to 24 hours post-dose in the Immediate and Sparse PK subgroup on Day 1. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 1|The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.|||hr*ng/mL||Standard Deviation|Mean
2581866|NCT02387983|Primary|Time to Steady-state Maximum Concentration (ssTmax) of Posaconazole on Day 8|The ssTmax was calculated in order to determine the amount of time required to reach ssCmax in the Intensive and Sparse PK subgroup on Day 8.|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8|The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.|||hr||Full Range|Median
2581867|NCT02387983|Primary|Steady-state Minimum Concentration (ssCmin) of Posaconazole on Day 8|The ssCmin was calculated in order to determine the lowest measurable drug concentration in the Intensive and Sparse PK subgroup up to 24 hours post-dose on Day 8. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8|The PK analysis set included all randomized and treated participants in the Intensive and Sparse subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.|||ng/mL||Standard Deviation|Mean
2581868|NCT02387983|Primary|Steady-state Maximum Concentration (ssCmax) of Posaconazole on Day 8|The ssCmax was calculated in order to determine the maximum post-dose plasma drug concentration in the Intensive and Sparse PK subgroup on Day 8. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8|The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation with available data.|||ng/mL||Standard Deviation|Mean
2581869|NCT02387983|Primary|Steady-state Area Under the Concentration-time Curve (ssAUC0-24hr) of Posaconazole on Day 8|The ssAUC0-24hr was calculated to determine the mean plasma drug concentration in the Intensive and Sparse PK subgroup from immediately after dosing to 24 hours post-dose on Day 8. Results data are presented as the arithmetic mean (% arithmetic coefficient of variation [CV]), where CV is calculated as (100 x standard deviation/arithmetic mean).|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8|The PK analysis set included all randomized and treated participants in the Intensive and Sparse PK subgroup who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation and have data available.|||hr*ng/mL||Standard Deviation|Mean
2581870|NCT02387983|Primary|Steady-state Average Concentration (ssCavg) of Posaconazole on Day 8|The ssCavg was calculated in order to determine the percentage of participants achieving the pharmacokinetic (PK) target of ssCavg >500 ng/mL on Day 8 when plasma drug levels had reached steady state.|Pre-dose and 2, 4, 6, 8, 12, and 24 hours post-dose on Day 8|The PK analysis set included all randomized and treated participants who complied with the protocol and have documented adherence to daily dosing and PK regimens through the Day 8 steady-state evaluation and have data available.|||Percentage of Participants|||Number
2581871|NCT02387970|Secondary|Mean Change in Peri-implant Mucosal Margin Level|Measurements of peri-implant mucosal margin levels will be measured at 6 months and 12 months post-procedure.|6 months and 12 months||||millimeters||Standard Deviation|Mean
2581872|NCT02387970|Secondary|Mean Change in Peri-implant Mucosal Margin Level|Measurements of peri-implant mucosal margin levels will be measured at baseline and 12 months post-procedure.|Baseline and 12 months||||millimeters||Standard Deviation|Mean
2581873|NCT02387970|Secondary|Mean Change in Peri-implant Mucosal Margin Level|Measurements of peri-implant mucosal margin levels will be measured at baseline and 6 months post-procedure.|Baseline and 6 months||||millimeters of tissue||Standard Deviation|Mean
2581874|NCT02387970|Primary|Radiographic Bone Level Distal to the Implant|Radiographic measurements of alveolar bone level distal to the implant (at surgical placement and 12 months) will be carried out using the MIPACS software. The implant platform will be the reference point.|Baseline and 12 months|Only includes individuals who completed the 1-year follow up.|||Millimeters||Standard Deviation|Mean
2581875|NCT02387970|Primary|Radiographic Bone Level Distal to the Implant|Radiographic measurements of alveolar bone level distal to the implant (at surgical placement and 6 months) will be carried out using the MIPACS software. The implant platform will be the reference point.|Baseline and 6 months|Only includes individuals with analyzable data.|||Millimeters||Standard Deviation|Mean
2581876|NCT02387970|Primary|Radiographic Bone Level Mesial to the Implant|Radiographic measurements of alveolar bone level mesial to the implant (at surgical placement and 12 months) will be carried out using the MIPACS software. The implant platform will be the reference point.|Baseline and 12 months|Only includes individuals who completed the 1-year follow up.|||Millimeters||Standard Deviation|Mean
2581877|NCT02387970|Primary|Radiographic Bone Level Mesial to the Implant|Radiographic measurements of alveolar bone level mesial to the implant (at surgical placement and 6 months) will be carried out using the MIPACS software. The implant platform will be the reference point.|Baseline and 6 months|Only includes individuals with analyzable data.|||Millimeters||Standard Deviation|Mean
2581880|NCT02387853|Secondary|Change in Itch as Assessed on a Visual Analog Scale (VAS) From Baseline to Week 4|Change in itch as assessed on a visual analog scale (VAS) from baseline to Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. The assessments were made on a 100 mm (100 mm = 10 cm) horizontal VAS anchored at 0 ('no itch at all') and 10 ('worst itch you can imagine'). Subjects were asked to put a vertical line on the scale at the spot he/she felt best reflected the maximal itch intensity during the last 24 hours. The distance from 0 to the subject's indication line was measured in mm, thus higher scores indicated a worse outcome.|From baseline to Week 4|Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.|||mm on VAS scale||Standard Deviation|Mean
2581881|NCT02387853|Secondary|Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Scalp at Week 4|Number of subjects with 'treatment success' according to the Subject's Global Assessment of disease severity on the scalp at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity.|Week 4|Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.|||Participants|||Count of Participants
2581882|NCT02387853|Secondary|Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Body at Week 4|Number of subjects with 'treatment success' according to the Subject's Global Assessment of disease severity on the body at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity.|Week 4|Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.|||Participants|||Count of Participants
2581883|NCT02387853|Secondary|Percentage Change in PASI From Baseline to Week 4|Percentage change in Psoriasis area and severity index (PASI) score from baseline to Week 4. Psoriasis area and severity index (PASI) assesses extent and severity of clinical signs of psoriasis vulgaris. Body surface is divided in 4 ares: head (incl. neck), arms (incl. hands), trunk (incl. flexures) and legs (incl. buttocks and feet). Each area is scored from 0-6 for extent of psoriasis and from 0-4 for redness, thickness, and scaliness, and an area PASI score is calculated. The total PASI score is calculated from each area's score. The PASI score ranges from 0 (clear skin) to 72 (maximum disease), a PASI score higher than 10 generally corresponds to moderate-to-severe disease.|From baseline to Week 4|Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.|||Percentage change in PASI||Standard Deviation|Mean
2581884|NCT02387853|Secondary|Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Scalp|Number of subjects with 'treatment success' according to Physician's Global Assessment (PGA) on Scalp in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA.|Week 4|Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.|||Participants|||Count of Participants
2581885|NCT02387853|Secondary|Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Body|Number of subjects with 'treatment success' according to Physician's Global Assessment (PGA) on Body in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA.|Week 4|Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.|||Participants|||Count of Participants
2581886|NCT02387853|Secondary|Change in Calcium:Creatinine Ratio in Spot Urine Samples From Baseline to Week 4|Change in calcium:creatinine ratio in spot urine samples from baseline to Week 4 in the spot urine non-HPA set, defined as all subjects in the safety analysis set who did not undergo HPA-axis testing.|From baseline to Week 4|Spot urine non-HPA set|||mmol/g||Standard Deviation|Mean
2581887|NCT02387853|Secondary|Number of Subjects With Serum Cortisol Concentration ≤18 mcg/dL at Both 30 and 60 Minutes After ACTH-challenge at Week 4|Number of subjects with serum cortisol concentration ≤18 mcg/dL at both 30 and 60 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline.|30 and 60 minutes after ACTH-challenge at Week 4|Per protocol analysis set|||Participants|||Count of Participants
2581888|NCT02387853|Primary|Change in Calcium:Creatinine Ratio in 24-hour Urine From Baseline to Week 4|Change in calcium:creatinine ratio in 24-hour urine collection from baseline to Week 4 in the 24-hour urine in HPA set, defined as all subjects in the safety analysis set who underwent HPA-axis testing.|From baseline to Week 4|24-hour urine in HPA set|||mmol/g||Standard Deviation|Mean
2581889|NCT02387853|Primary|Change in Calcium Excretion in 24-hour Urine From Baseline to Week 4|Change in calcium excretion in 24-hour urine collection from baseline to Week 4 in the 24-hour urine HPA set, defined as all subjects in the safety analysis set. The safety analysis set is defined, according to the Consolidated Trial Protocol, by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.|From baseline to Week 4|24-hour urine HPA set|||mmol/24hr||Standard Deviation|Mean
2581890|NCT02387853|Primary|Change in Albumin-corrected Serum Calcium From Baseline to Week 4|Change in albumin-corrected serum calcium from baseline to Week 4 in safety analysis set. The safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.|From baseline to Week 4|Safety analysis set|||mmol/L||Standard Deviation|Mean
2582084|NCT02384200|Secondary|Participants With Positive Renal Pelvic Urine Culture|percutaneously taken renal pelvic urine culture|once at time of surgery, within 10 minutes of obtaining percutaneous access to the kidney||||Participants|||Count of Participants
2581891|NCT02387853|Primary|Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4|Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline.|30 minutes after ACTH-challenge at Week 4|Per protocol analysis set|||Participants|||Count of Participants
2581892|NCT02387853|Primary|Number of Subjects With Adverse Events (AEs)|Number of subjects with adverse events in the safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.|From Week -1 to Week 8|Safety analysis set|||Participants|||Count of Participants
2581893|NCT02387814|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity(AUC[0-inf]) of Abemaciclib and Active Metabolites||Day 1: Predose, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose|All participants who received abemaciclib and had evaluable plasma values.|||nanograms*hours/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2581894|NCT02387814|Primary|Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Abemaciclib and Active Metabolites||Day 1: Predose, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose|All participants who received abemaciclib and had evaluable plasma values.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2581895|NCT02387801|Secondary|Time to at Least a 2 Point Improvement on the PatGA Score|"The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 NRS the severity of their psoriasis today from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been."|Baseline though Week 12|All randomized participants.|||Days||90% Confidence Interval|Median
2581896|NCT02387801|Secondary|Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in PASI scores compared to baseline. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction.|Baseline, Week 12|All randomized participants.|||units on a scale||Standard Error|Least Squares Mean
2581897|NCT02387801|Secondary|Mean Change From Baseline in Percent Body Surface Area (%BSA)|The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. LS means are from analysis of MMRM and the model includes treatment group, baseline value, visit and treatment-by-visit interaction|Baseline, Week 12|All randomized participants.|||percentage of body surface area||Standard Error|Least Squares Mean
2581898|NCT02387801|Secondary|Mean Change From Baseline on the Dermatology Life Quality Index (DLQI)|"The DLQI is a simple, patient-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include Not at all, A little, A lot, and Very much, with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of Not relevant which is scored as 0. For all questions, if unanswered the question is scored as 0. Totals range from 0 to 30 (less to more impairment). LS means are from analysis of MMRM and model includes treatment group, baseline value and timepoint."|Baseline, Week 12|All randomized participants.|||units on a scale||Standard Error|Least Squares Mean
2581899|NCT02387801|Secondary|Mean Change From Baseline on Itch Numeric Rating Scale (NRS) Score|"The Itch NRS is a patient-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participant's itching from psoriasis (Ps) is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Least Square Means (LS means) are from analysis of mixed-effects model for repeated measures (MMRM) and model includes treatment group, baseline value and timepoint."|Baseline, Week 12|All randomized participants.|||units on a scale||Standard Error|Least Squares Mean
2581900|NCT02387801|Primary|Time to at Least a 1 Point Improvement on the Patient's Global Assessment of Disease Severity (PatGA) Score|"The PatGA is a patient-administered single-item scale on which participants are asked to rank by selecting a number on a 0 to 5 Numeric Rating Score (NRS) the severity of their psoriasis today from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been."|Baseline through Week 12|All randomized participants.|||Days||90% Confidence Interval|Median
2581901|NCT02387762|Primary|Disease Activity Score 28-CRP (DAS28-CRP) at Week 4|Disease activity score 28 - C-reactive protein (DAS28-CRP) is a score to measure disease activity in patients with rheumatoid arthritis by aggregating data of 28 joints, and is calculated by the scores on scale using the following variables: The number of swollen and tender joints, CRP level, and patient's global assessment of disease activity. The total score of the DAS28 values may range from 2.0 to 10.0 while higher values mean a higher disease activity.|4 weeks|Intent-to-treat population, which included all randomized subjects|||Scores on scale||Standard Deviation|Mean
2581902|NCT02387749|Secondary|Change of Levels of Glycated Haemoglobin( HA1C) After Stem Cells Transfusion Measured in Percent %|Blood tests before and after stem cells(90 days) transfusion and comparing the values in percent % which is reflecting the patient blood sugar control in the previous 3 months|at base line (zero day) and 90 days after stem cells transfusion||||percent %||Standard Deviation|Mean
2581903|NCT02387749|Secondary|Change of Levels of Fasting Blood Sugar and 2 Hours Post Prandial at Base Line ( Zero Day ) and After (90 Days) After Stem Cells Transfusion|fasting, 2 hours postprandial blood sugar measurement before at base line (zero day) and after (90 days) stem cells transfusion as a follow up and comparing the values.|base line (zero day) and 90 days after stem cells transfusion||||mg/dl||Standard Deviation|Mean
2601690|NCT02150837|Secondary|Abdominal Circumference|Abdominal circumference expressed as an absolute change from baseline.|16 weeks||||Inches||Standard Deviation|Mean
2581906|NCT02387749|Primary|Change of Nerve Conduction Velocities of Nerves Affected Measured by Nerve Conduction Study.|Measuring nerve conduction velocities(NCV) in m/sec upper and lower limbs nerves(sensory and motor) lower limb nerves : tibial , common peroneal(CP) as motor and sural nerve as sensory upper limb nerves: ulnar nerve as motor and sensory and compare at base line(zero day) and 90 days after stem cells transfusion|base line(zero dya), 90 days after stem cells transfusion.||||m/sec||Standard Deviation|Mean
2581907|NCT02387749|Primary|Measurement of b-FGF, v-EGF MEASURED BY ELISA|measurement of b-FGF and v-EGF MEASURED BY ELISA before (at zero), and after at (7 days, 90) days after stem cell transfusion to measure the effect of stem cell and its role in nerve regeneration|zero ( before) , 7 DAYS, 90 days|b-FGF, V-EGF (pg/ml) measured at zero, 7 days after stem cell transfusion measured by ELISA to measure the effectiveness of stem cells and as an indication for nerve regeneration|||pg/ml||Standard Deviation|Mean
2581908|NCT02387710|Secondary|Arousal Threshold (Esophageal Pressure Swing)|The arousal threshold was quantified as the mean of all the nadir negative esophageal pressure swings immediately preceding an arousal at the end of an obstructive apnea or hypopnea during both placebo and tiagabine nights.|1 night||||cmH2O||Inter-Quartile Range|Median
2581909|NCT02387710|Secondary|Slow Wave Sleep (% Total Sleep Time)|Fraction of sleep spent in stage N3|1 night||||% total sleep time||Inter-Quartile Range|Median
2581910|NCT02387710|Primary|Apnea Hypopnea Index (AHI)|Number of apneas + hypopneas per hour of sleep. Hypopnea criteria: reduction in 30% of baseline flow plus 3% desaturation or arousal.|1 night||||events/hour||Inter-Quartile Range|Median
2581911|NCT02387580|Primary|Piperaquine AUC(0-168 h)|PQP Area under the plasma concentration versus time curve|Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours and Day36 post-dose|The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2581912|NCT02387580|Primary|Piperaquine Cmax|Piperaquine Maximum observed concentration|Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours and Day36 post-dose|The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2581913|NCT02387580|Primary|OZ439 AUC(0-168 h)|OZ439 Area under the plasma concentration (AUC) versus time curve|pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dose|The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2581914|NCT02387580|Primary|OZ439 Cmax|OZ439 Maximum observed concentration|Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dose|The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2581915|NCT02387554|Other Pre-specified|Number of Paticipants With Adverse Events||3 months|||||||
2581916|NCT02387554|Secondary|Vz/F|Vz/F(Apparent volume of distribution)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr|||||||
2581917|NCT02387554|Secondary|CL/F|CL/F(Apparent clearance)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr|||||||
2581918|NCT02387554|Secondary|T1/2|T1/2(Terminal elimination half-life),|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr|||||||
2581919|NCT02387554|Secondary|Tmax|Tmax(Time to maximum concentration)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr|||||||
2581920|NCT02387554|Secondary|AUCinf|AUCinf(Area under the curve to infinity)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr|||||||
2581921|NCT02387554|Primary|Cmax|Cmax(maxium concentration)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr|||||||
2581922|NCT02387554|Primary|AUClast|AUClast(Area under the curve to the last measurable concentration)|0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr||||Ratio(Comb/Alone)||90% Confidence Interval|Geometric Mean
2581923|NCT02387502|Primary|Time of Intubation|Time of intubation is defined as the time from passing the device beyond the incisors to the confirmation of endotracheal tube placement by square wave capnograph tracings.|up to 10 minutes||||seconds||Standard Deviation|Mean
2581924|NCT02387476|Secondary|REM (Min)|The exact function of the REM is uncertain. However, it occupies approximately 25% of the total sleep time. REM sleep cycles occur every 90 to 120 min throughout the night with progressively increasing periods of time. REM sleep is associated with more frequent and longer duration apneas, hypopneas, and severe hypoxemia|per night|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||minutes||Standard Deviation|Mean
2581925|NCT02387476|Secondary|Stage N3 (Min)|Stage N3 is considered as 'deep sleep'. It is sometimes referred as slow wave sleep.|per night|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||minutes||Standard Deviation|Mean
2581926|NCT02387476|Secondary|Stage N2 (Min)|Stage N2 sleep predominates the sleep stages with 50% of the total sleep time. It follows the Stage N1 sleep and continues to recur throughout the night.|per night|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||minutes||Standard Deviation|Mean
2581927|NCT02387476|Secondary|Stage N1 (Min)|Stage N1 sleep is an estimate of the degree of sleep fragmentation.|per night|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||minutes||Standard Deviation|Mean
2601691|NCT02150837|Secondary|Abdominal Circumference|Abdominal circumference expressed as an absolute change from baseline.|8 weeks||||Inches||Standard Deviation|Mean
2581929|NCT02387476|Secondary|Mean Sleep SpO2 -(%)|Mean Sleep SpO2 - blood oxygenation level (%) mean value reported per treatment|per night|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||percentage of O2 Saturation||Standard Deviation|Mean
2581930|NCT02387476|Secondary|Minimum Sleep SpO2 (%)|The minimum O2 level percentage during treatment reported per treatment|per night||||percentage of O2 Saturation||Standard Deviation|Mean
2581931|NCT02387476|Secondary|Sleep Efficiency (SE%)|Sleep Efficiency (%) [100 x Total sleep time/ total recording time] reported per treatment|per night|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||percentage of sleep efficiency||Standard Deviation|Mean
2581932|NCT02387476|Secondary|Arousal Index (AI)|The number of arousals per hour; arousals are defined as a change in EEG for at least 3 seconds.|per hour|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||events per hour||Standard Deviation|Mean
2581933|NCT02387476|Primary|Oxygen Desaturation Index (ODI)|The Oxygen Desaturation Index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline. The ODI is typically measured as part of standard sleep studies, such as a diagnostic polysomnogram, home sleep apnea testing, or with overnight oximetry.Difference of ODI values between patients who used the FRESCA treatment first versus the CPAP treatment.|per hour|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||events per hour||Standard Deviation|Mean
2581934|NCT02387476|Primary|Apnea Hypopnea Index (AHI)|The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. Difference of AHI values between patients who used the FRESCA treatment first versus the CPAP treatment.|per hour|The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.|||events per hour||Standard Deviation|Mean
2581935|NCT02387372|Secondary|CL of Ceftolozane/Tazobactam in Critically Ill Participants With Augmented Renal Function.|Critically ill participants received a 60 minute infusion of ceftolozane/tazobactam, adjusted for CLCR, every 8 hours; then blood samples were collected at 1, 2, 4, 6, and 8 hours post start of the final infusion after the last dose of study drug in order to determine the CL of ceftolozane or tazobactam. PK data analysis was performed by NCA method using Phoenix WinNonlin version 6.3 or later.|Day 1 at 0 (pre-dose), 1, 2, 4, 6 and 8 h after the start of infusion|All critically ill participants who received at least 1 dose of study drug at the correctly assigned dose level, and whose plasma drug concentration was determined. Mechanically ventilated participants were not analyzed in this outcome measure.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2581936|NCT02387372|Secondary|Vss of Ceftolozane/Tazobactam in Critically Ill Participants With Augmented Renal Function.|Critically ill participants received a 60 minute infusion of ceftolozane/tazobactam, adjusted for CLCR, every 8 hours; then blood samples were collected at 1, 2, 4, 6, and 8 hours post start of the final infusion after the last dose of study drug in order to determine the Vss of ceftolozane or tazobactam. PK data analysis was performed by NCA method using Phoenix WinNonlin version 6.3 or later.|Day 1 at 0 (pre-dose), 1, 2, 4, 6 and 8 h after the start of infusion|All critically ill participants who received at least 1 dose of study drug at the correctly assigned dose level, and whose plasma drug concentration was determined. Mechanically ventilated participants were not analyzed in this outcome measure.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2581937|NCT02387372|Secondary|T1/2 of Ceftolozane/Tazobactam in Critically Ill Participants With Augmented Renal Function.|Critically ill participants received a 60 minute infusion of ceftolozane/tazobactam, adjusted for CLCR, every 8 hours; then blood samples were collected at 1, 2, 4, 6, and 8 hours post start of the final infusion after the last dose of study drug in order to determine the T1/2 of ceftolozane or tazobactam. PK data analysis was performed by NCA method using Phoenix WinNonlin version 6.3 or later.|Day 1 at 0 (pre-dose), 1, 2, 4, 6 and 8 h after the start of infusion|All critically ill participants who received at least 1 dose of study drug at the correctly assigned dose level, and whose plasma drug concentration was determined. Mechanically ventilated participants were not analyzed in this outcome measure.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2581938|NCT02387372|Secondary|AUC0-∞ of Ceftolozane/Tazobactam in Critically Ill Participants With Augmented Renal Function.|Critically ill participants received a 60 minute infusion of ceftolozane/tazobactam, adjusted for CLCR, every 8 hours; then blood samples were collected at 1, 2, 4, 6, and 8 hours post start of the final infusion after the last dose of study drug in order to determine the AUC0-∞ of ceftolozane or tazobactam. PK data analysis was performed by NCA method using Phoenix WinNonlin version 6.3 or later.|Day 1 at 0 (pre-dose), 1, 2, 4, 6 and 8 h after the start of infusion|All critically ill participants who received at least 1 dose of study drug at the correctly assigned dose level, and whose plasma drug concentration was determined. Mechanically ventilated participants were not analyzed in this outcome measure.|||h*ug/mL||95% Confidence Interval|Geometric Mean
2581939|NCT02387372|Secondary|AUC0-last of Ceftolozane/Tazobactam in Critically Ill Participants With Augmented Renal Function.|Critically ill participants received a 60 minute infusion of ceftolozane/tazobactam, adjusted for CLCR, every 8 hours; then blood samples were collected at 1, 2, 4, 6, and 8 hours post start of the final infusion after the last dose of study drug in order to determine the AUC0-last of ceftolozane or tazobactam. PK data analysis was performed by NCA method using Phoenix WinNonlin version 6.3 or later.|Day 1 at 0 (pre-dose), 1, 2, 4, 6 and 8 h after the start of infusion|All critically ill participants who received at least 1 dose of study drug at the correctly assigned dose level, and whose plasma drug concentration was determined. Mechanically ventilated participants were not analyzed in this outcome measure.|||h*ug/mL||95% Confidence Interval|Geometric Mean
2582626|NCT02377362|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Non-Zero Concentration (AUC0-t) (Part A)||Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose||||µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2581940|NCT02387372|Secondary|Tlast of Ceftolozane/Tazobactam in Critically Ill Participants With Augmented Renal Function.|Critically ill participants received a 60 minute infusion of ceftolozane/tazobactam, adjusted for CLCR, every 8 hours; then blood samples were collected at 1, 2, 4, 6, and 8 hours post start of the final infusion after the last dose of study drug in order to determine the Tlast of ceftolozane or tazobactam. PK data analysis was performed by NCA method using Phoenix WinNonlin version 6.3 or later.|Day 1 at 0 (pre-dose), 1, 2, 4, 6 and 8 h after the start of infusion|All critically ill participants who received at least 1 dose of study drug at the correctly assigned dose level, and whose plasma drug concentration was determined. Mechanically ventilated participants were not analyzed in this outcome measure.|||Hours||Full Range|Median
2581941|NCT02387372|Secondary|Clast of Ceftolozane/Tazobactam in Critically Ill Participants With Augmented Renal Function.|Critically ill participants received a 60 minute infusion of ceftolozane/tazobactam, adjusted for CLCR, every 8 hours; then blood samples were collected at 1, 2, 4, 6, and 8 hours post start of the final infusion after the last dose of study drug in order to determine the Clast of ceftolozane or tazobactam. PK data analysis was performed by NCA method using Phoenix WinNonlin version 6.3 or later.|Day 1 at 0 (pre-dose), 1, 2, 4, 6 and 8 h after the start of infusion|All critically ill participants who received at least 1 dose of study drug at the correctly assigned dose level, and whose plasma drug concentration was determined. Mechanically ventilated participants were not analyzed in this outcome measure.|||ug/mL||95% Confidence Interval|Geometric Mean
2581942|NCT02387372|Secondary|Tmax of Ceftolozane/Tazobactam in Critically Ill Participants With Augmented Renal Function.|Critically ill participants received a 60 minute infusion of ceftolozane/tazobactam, adjusted for CLCR, every 8 hours; then blood samples were collected at 1, 2, 4, 6, and 8 hours post start of the final infusion after the last dose of study drug in order to determine the Tmax of ceftolozane or tazobactam. PK data analysis was performed by NCA method using Phoenix WinNonlin version 6.3 or later.|Day 1 at 0 (pre-dose), 1, 2, 4, 6 and 8 h after the start of infusion|All critically ill participants who received at least 1 dose of study drug at the correctly assigned dose level, and whose plasma drug concentration was determined. Mechanically ventilated participants were not analyzed in this outcome measure.|||Hours||Full Range|Median
2581943|NCT02387372|Secondary|Cmax of Ceftolozane/Tazobactam in Critically Ill Participants With Augmented Renal Function.|Critically ill participants received a 60 minute infusion of ceftolozane/tazobactam, adjusted for CLCR, every 8 hours; then blood samples were collected at 1, 2, 4, 6, and 8 hours post start of the final infusion after the last dose of study drug in order to determine the Cmax of ceftolozane or tazobactam. PK data analysis was performed by NCA method using Phoenix WinNonlin version 6.3 or later.|Day 1 at 0 (pre-dose), 1, 2, 4, 6 and 8 h after the start of infusion|All critically ill participants who received at least 1 dose of study drug at the correctly assigned dose level, and whose plasma drug concentration was determined. Mechanically ventilated participants were not analyzed in this outcome measure.|||ug/mL||95% Confidence Interval|Geometric Mean
2581944|NCT02387372|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Up to 5 days|All treated participants|||Participants|||Count of Participants
2581945|NCT02387372|Primary|Plasma Clearance (CL) of Ceftolozane or Tazobactam in Mechanically Ventilated Participants for the First and Last Dose of Ceftolozane/Tazobactam Treatment.|Mechanically ventilated participants received a 60 minute infusion of ceftolozane/tazobactam, adjusted for CLCR, every 8 hours; then blood samples were collected at 1, 2, 4, 6, and 8 hours post start of the final infusion after the last dose of study drug in order to determine the CL, plasma clearance, of ceftolozane or tazobactam. PK data analysis was performed by NCA method using Phoenix WinNonlin version 6.3 or later.|Day 1 up to Day 2 at 0 (pre-dose), 1, 2, 4, 6 and 8 hours (h) after the start of the first and last infusions.|All mechanically ventilated participants who received at least 1 dose of study drug at the correctly assigned dose level, and whose plasma drug concentration was determined. Critically ill participants were not analyzed in this outcome measure.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2581946|NCT02387372|Primary|Volume of Distribution at Steady State (Vss) of Ceftolozane or Tazobactam in Mechanically Ventilated Participants for the First and Last Dose of Ceftolozane/Tazobactam Treatment.|Mechanically ventilated participants received a 60 minute infusion of ceftolozane/tazobactam, adjusted for CLCR, every 8 hours; then blood samples were collected at 1, 2, 4, 6, and 8 hours post start of the final infusion after the last dose of study drug in order to determine the Vss, volume of distribution at steady state, of ceftolozane or tazobactam. PK data analysis was performed by NCA method using Phoenix WinNonlin version 6.3 or later.|Day 1 up to Day 2 at 0 (pre-dose), 1, 2, 4, 6 and 8 hours (h) after the start of the first and last infusions.|All mechanically ventilated participants who received at least 1 dose of study drug at the correctly assigned dose level, and whose plasma drug concentration was determined. Critically ill participants were not analyzed in this outcome measure.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2581947|NCT02387372|Primary|Terminal Elimination Half-life (t1/2) of Ceftolozane or Tazobactam in Mechanically Ventilated Participants for the First and Last Dose of Ceftolozane/Tazobactam Treatment.|Mechanically ventilated participants received a 60 minute infusion of ceftolozane/tazobactam, adjusted for CLCR, every 8 hours; then blood samples were collected at 1, 2, 4, 6, and 8 hours post start of the final infusion after the last dose of study drug in order to determine the t1/2, terminal elimination half-life, of ceftolozane or tazobactam. PK data analysis was performed by NCA method using Phoenix WinNonlin version 6.3 or later.|Day 1 up to Day 2 at 0 (pre-dose), 1, 2, 4, 6 and 8 hours (h) after the start of the first and last infusions.|All mechanically ventilated participants who received at least 1 dose of study drug at the correctly assigned dose level, and whose plasma drug concentration was determined. Critically ill participants were not analyzed in this outcome measure.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2581955|NCT02387359|Secondary|Change From Baseline in Abdominal Pain|Change from baseline in abdominal pain as measured with an 11-point (0-10) Numerical Rating Scale from 0 (No) to 10 (Worst Possible). Baseline is the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.|Baseline and 12-Week||||score on a scale||Standard Deviation|Mean
2581948|NCT02387372|Primary|AUC From the Time of the Dose to Infinity (AUC0-∞) of Ceftolozane or Tazobactam in Mechanically Ventilated Participants for the First and Last Dose of Ceftolozane/Tazobactam Treatment.|Mechanically ventilated participants received a 60 minute infusion of ceftolozane/tazobactam, adjusted for CLCR, every 8 hours; then blood samples were collected at 1, 2, 4, 6, and 8 hours post start of the final infusion after the last dose of study drug in order to determine the AUC0-∞, AUC from the time of the dose to infinity, of ceftolozane or tazobactam. PK data analysis was determined by NCA method using Phoenix WinNonlin version 6.3 or later.|Day 1 up to Day 2 at 0 (pre-dose), 1, 2, 4, 6 and 8 hours (h) after the start of the first and last infusions.|All mechanically ventilated participants who received at least 1 dose of study drug at the correctly assigned dose level, and whose plasma drug concentration was determined. Critically ill participants were not analyzed in this outcome measure.|||h*ug/mL||95% Confidence Interval|Geometric Mean
2581949|NCT02387372|Primary|Area Under the Concentration Time Curve (AUC) From the First to Time of the Last Dose (AUC0-last) of Ceftolozane or Tazobactam in Mechanically Ventilated Participants for the First and Last Dose of Ceftolozane/Tazobactam Treatment.|Mechanically ventilated participants received a 60 minute infusion of ceftolozane/tazobactam, adjusted for CLCR, every 8 hours; then blood samples were collected at 1, 2, 4, 6, and 8 hours post start of the final infusion after the last dose of study drug in order to determine the AUC0-last, AUC from the first to time of the last dose, of ceftolozane or tazobactam. PK data analysis was determined by NCA method using Phoenix WinNonlin version 6.3 or later.|Day 1 up to Day 2 at 0 (pre-dose), 1, 2, 4, 6 and 8 hours (h) after the start of the first and last infusions.|All mechanically ventilated participants who received at least 1 dose of study drug at the correctly assigned dose level, and whose plasma drug concentration was determined. Critically ill participants were not analyzed in this outcome measure.|||h*ug/mL||95% Confidence Interval|Geometric Mean
2581950|NCT02387372|Primary|Time of Last Quantifiable Plasma Concentration (Tlast)) of Ceftolozane or Tazobactam in Mechanically Ventilated Participants for the First and Last Dose of Ceftolozane/Tazobactam Treatment.|Mechanically ventilated participants received a 60 minute infusion of ceftolozane/tazobactam, adjusted for CLCR, every 8 hours; then blood samples were collected at 1, 2, 4, 6, and 8 hours post start of the final infusion after the last dose of study drug in order to determine the Tlast, time of last quantifiable plasma concentration, of ceftolozane or tazobactam. PK data analysis was determined by NCA method using Phoenix WinNonlin version 6.3 or later.|Day 1 up to Day 2 at 0 (pre-dose), 1, 2, 4, 6 and 8 hours (h) after the start of the first and last infusions.|All mechanically ventilated participants who received at least 1 dose of study drug at the correctly assigned dose level, and whose plasma drug concentration was determined. Critically ill participants were not analyzed in this outcome measure.|||Hours||Full Range|Median
2581951|NCT02387372|Primary|Last Quantifiable Plasma Concentration (Clast) of Ceftolozane or Tazobactam in Mechanically Ventilated Participants for the First and Last Dose of Ceftolozane/Tazobactam Treatment.|Mechanically ventilated participants received a 60 minute infusion of ceftolozane/tazobactam, adjusted for CLCR, every 8 hours; then blood samples were collected at 1, 2, 4, 6, and 8 hours post start of the final infusion after the last dose of study drug in order to determine the Clast, last quantifiable plasma concentration, of ceftolozane or tazobactam. PK data analysis was performed by NCA method using Phoenix WinNonlin version 6.3 or later.|Day 1 up to Day 2 at 0 (pre-dose), 1, 2, 4, 6 and 8 hours (h) after the start of the first and last infusions.|All mechanically ventilated participants who received at least 1 dose of study drug at the correctly assigned dose level, and whose plasma drug concentration was determined. Critically ill participants were not analyzed in this outcome measure.|||ug/mL||95% Confidence Interval|Geometric Mean
2581952|NCT02387372|Primary|Time of Maximum Plasma Concentration (Tmax) of Ceftolozane or Tazobactam in Mechanically Ventilated Participants for the First and Last Dose of Ceftolozane/Tazobactam Treatment.|Mechanically ventilated participants received a 60 minute infusion of ceftolozane/tazobactam, adjusted for CLCR, every 8 hours; then blood samples were collected at 1, 2, 4, 6, and 8 hours post start of the final infusion after the last dose of study drug in order to determine the Tmax, time of maximum plasma concentration, of ceftolozane or tazobactam. PK data analysis was performed by NCA method using Phoenix WinNonlin version 6.3 or later.|Day 1 up to Day 2 at 0 (pre-dose), 1, 2, 4, 6 and 8 hours (h) after the start of the first and last infusions.|All mechanically ventilated participants who received at least 1 dose of study drug at the correctly assigned dose level, and whose plasma drug concentration was determined. Critically ill participants were not analyzed in this outcome measure.|||Hours||Full Range|Median
2581953|NCT02387372|Primary|Epithelial Lining Fluid (ELF) / Plasma Ratio (Intrapulmonary Penetration) of Ceftolozane and Tazobactam Concentrations in Mechanically Ventilated Participants.|Mechanically ventilated participants received a 60 minute infusion of ceftolozane/tazobactam, adjusted for CLCR, every 8 hours; then blood samples and epithelial lining fluid (ELF) were collected at 1, 2, 4, 6, and 8 hours post start of the final infusion after the last dose of study drug in order to determine the epithelial lining fluid, ELF to plasma ratio of ceftolozane and tazobactam.|Up to Day 2 at 0 (pre-dose), 1, 2, 4, 6 and 8 h after the start of the last infusion.|All mechanically ventilated participants who received at least 1 dose of study drug at the correctly assigned dose level, and whose plasma and ELF drug concentrations were both determined. Critically ill participants were not analyzed in this outcome measure.|||Ratio||Standard Deviation|Mean
2581954|NCT02387372|Primary|Maximum Plasma Concentration (Cmax) of Ceftolozane or Tazobactam in Mechanically Ventilated Participants for the First and Last Dose of Ceftolozane/Tazobactam Treatment.|Mechanically ventilated participants received a 60 minute infusion of ceftolozane/tazobactam, adjusted for creatinine clearance (CLCR), every 8 hours; then blood samples were collected at 1, 2, 4, 6, and 8 hours post start of the final infusion after the last dose of study drug in order to determine the Cmax, maximum plasma concentration, of ceftolozane or tazobactam. Pharmacokinetic (PK) data analysis was performed by non-compartmental analysis (NCA) method using Phoenix WinNonlin version 6.3 or later.|Day 1 up to Day 2 at 0 (pre-dose), 1, 2, 4, 6 and 8 hours (h) after the start of the first and last infusions.|All mechanically ventilated participants who received at least 1 dose of study drug at the correctly assigned dose level, and whose plasma drug concentration was determined. Critically ill participants were not analyzed in this outcome measure.|||ug/mL||95% Confidence Interval|Geometric Mean
2581956|NCT02387359|Secondary|Number of Patients With a SBM Within 24 Hours After the First Dose|Number of patients with a SBM (spontaneous bowel movement) within 24 hours after the first dose of study drug|Up to 24 hours after first dose of study drug||||Participants|||Count of Participants
2581957|NCT02387359|Secondary|Change From Baseline in CSBM Frequency Rate|Change from baseline over the 12-week Treatment Period in CSBM (Complete Spontaneous Bowel Movement) Frequency Rate (CSBMs/Week). Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.|Baseline and 12-Week||||CSBMs per week||Standard Deviation|Mean
2581958|NCT02387359|Secondary|Change From Baseline in Straining|Change from baseline in Straining Score over the 12-week treatment period. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The severity of straining during a bowel movement was measured using an 11-point scale (0-10 rating; 0 = no straining; 10 = worst straining).|Baseline and 12-week||||score on a scale||Standard Deviation|Mean
2581959|NCT02387359|Secondary|Change From Baseline in Stool Consistency|"Change from baseline in stool consistency based upon the Bristol Stool Form Scale (BSFS) Rating 1 to 7. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS Rating 1 to 7:~Separate hard lumps, like nuts (hard to pass)~Sausage-shaped but lumpy~Like a sausage but with cracks on its surface~Like a sausage or snake, smooth and soft~Soft blobs with clear-cut edges (passed easily)~Fluffy pieces with ragged edges, a mushy stool~Watery, no solid pieces, entirely liquid"|Baseline and 12-Week||||score on a scale||Standard Deviation|Mean
2581960|NCT02387359|Secondary|Number of Sustained Efficacy Responders|A Sustained Efficacy Responder was a patient who was an Overall Responder who also was a Weekly Responder, i.e., decreased of 30% from baseline for abdominal pain intensity and increased of at least one CSBM (complete spontaneous bowel movement) in the same week for at least 2 of the 4 weeks in month 3 of the Treatment Period.|12 weeks||||Participants|||Count of Participants
2581961|NCT02387359|Primary|Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks|A Stool Frequency Responder is defined as a patient who experienced an increase of at least one CSBM (complete spontaneous bowel movement) per week from baseline. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.|12 weeks||||Participants|||Count of Participants
2581962|NCT02387359|Primary|Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks|An Abdominal Pain Intensity Responder was a patient who had a decrease of 30% from baseline for abdominal pain intensity. Baseline was the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.|12 Weeks||||Participants|||Count of Participants
2581963|NCT02387359|Primary|Number of Overall Responders - ITT Population|An Overall Responder was a patient who was a Weekly Responder (i.e., decrease of 30% from baseline for abdominal pain intensity and an increase of at least one complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks.|12 Weeks||||Participants|||Count of Participants
2581964|NCT02387268|Secondary|Percentage of Participants in Whom the Cecum Was Reached|A procedure was considered complete when the cecum was reached and visualized.|During the colonoscopy procedure||||percentage of participants||95% Confidence Interval|Number
2581965|NCT02387268|Primary|Safety as Measured by Number of Serious Adverse Events and Major Complications.||Max of 9 days|||||||
2581966|NCT02387268|Primary|Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 )|"Scale ranges- Min-0, Max-3 where:~0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.~= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid.~= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well.~= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. The wording of the scale was finalized after incorporating feedback from three colleagues experienced in colonoscopy."|During the colonoscopy procedure withdrawal phase (10 min in average)||||percentage of participants||95% Confidence Interval|Number
2581967|NCT02387008|Secondary|Membrane Exposure|The presence of membrane exposure or soft tissue dehiscence will be visually assessed.|7 days, 14 days, 28 days, 6 months|No participants were randomized to the GUIDOR® Membrane Alone Arm|||Participants|||Count of Participants
2581968|NCT02387008|Secondary|Infection|The presence or absence of infection in the area of ridge augmentation will be assessed through visual evaluation and palpation. The presence of suppuration from the crestal incision or soft tissues adjacent to the localized ridge augmentation will be assessed through visual evaluation. Fluctuance in the area of the augmentation will be assessed through gentle palpation of the surgical site.|7 days, 14 days, 28 days, 6 months|No participants were randomized to the GUIDOR® Membrane Alone Arm|||Participants|||Count of Participants
2581969|NCT02387008|Secondary|Inflammation|The presence or absence of soft tissue erythema within 3 mm from the crestal incision in the edentulous site will be visually assessed at post-operative evaluations.|7 days, 14 days, 28 days, 6 months|No participants were randomized to the GUIDOR® Membrane Alone Arm|||Participants|||Count of Participants
2581970|NCT02387008|Primary|Dimensional Bone Changes at 6 Months|Dimensional bone changes will assessed by calculating horizontal width and vertical height changes using data from DICOM images acquired by Cone beam computed tomography (CBCT).|6 months after treatment|Protocol-defined collection intervals were not achieved for any subjects enrolled; therefore, no data available for this measure.||||||
2581971|NCT02386345|Other Pre-specified|Number of Participants With 6-Month Safety Success|Success was defined as freedom from Serious Adverse Events at 6-months after index procedure|6-months after index procedure||||Participants|||Count of Participants
2581972|NCT02386345|Primary|Number of Participants With 12-Month Safety Success|Success was defined as freedom from Serious Adverse Events at 12-months after index procedure|12-months after index procedure||||Participants|||Count of Participants
2581973|NCT02386345|Primary|Number of Participants With Acute Safety Success|Acute safety success was defined as freedom from Serious Adverse Events at 7 days after index procedure|7 days after index procedure||||Participants|||Count of Participants
2581974|NCT02386345|Primary|Number of Participants With 12-Month Success|Single procedure freedom from atrial fibrillation recurrence|12-months after index procedure||||Participants|||Count of Participants
2581975|NCT02386345|Primary|Number of Participants With Acute Success|Acute Success was defined as the elimination (by ablation) of all identified rotors|day of procedure||||Participants|||Count of Participants
2581976|NCT02386189|Secondary|Relational Coordination Community Providers|Relational Coordination was assessed using Gittell's 7-item measure as described iRelational coordination amongst health professionals involved in insulin initiation for people with type 2 diabetes in general practice: an exploratory survey. The scale total score could range from 7 to 35 with higher scores indicating greater relational coordination.|Providers completed the coordination measure at the time of the medical visit which could occur at any point in the 12 month follow-up period.|This analysis population is based on community providers who actually returned the assessment provided by the patient.|||units on a scale||Standard Deviation|Mean
2581977|NCT02386189|Secondary|Relational Coordination- VA Providers|Relational Coordination was assessed using Gittell's 7-item measure as described Relational coordination amongst health professionals involved in insulin initiation for people with type 2 diabetes in general practice: an exploratory survey. This was assessed by providers seeing patients enrolled in this study, and this outcome is based on VA providers assessment of Relational Coordination. The scale total score could range from 7 to 35 with higher scores indicating greater relational coordination.|Providers completed the coordination measure at the time of the medical visit which could occur at any point in the 12 month follow-up period.|Veterans gave providers this measure at the medical visit and asked them to complete it and mail it to the study team.|||units on a scale||Standard Deviation|Mean
2581978|NCT02386189|Secondary|Proportion of Medication Concordance|All participants had at least one VA medical visit and one community medical visit. Medical records were obtained from both visits. Medication lists were obtained from both visits. A medication concordance metric (proportion) was calculated where the denominator was the total number of unique medications identified on both the VA medication list and the community provider medication list. The numerator was the total number of medications (including dose and frequency) that were concordant between the medication lists. This comparison did not include over the counter medications.|Time frame between two medical visits occuring within the one year study period|This sample is based on all participants for whom we had both the VA medication list and the community provider list. We obtained the VA medication list for all, but did not receive all medical records from community providers even after repeated requests.|||Proportion of medications concordant||Standard Deviation|Mean
2581979|NCT02386189|Secondary|Number of Participants With Duplication of Laboratory Tests|Participants had at least one VA medical visit and one community medical visit. Medical records were obtained from both visits and compared. Patients were considered to have a laboratory duplication if the same labs were drawn at both visits and the two visits occurred within three months of each other.|Baseline assessment to 12 months post-baseline, where a laboratory duplication is only counted if the medical visits occurred within three months of each other.||||Participants|||Count of Participants
2581980|NCT02386189|Primary|Patient Perceived Continuity of Care From Multiple Clinicians- Role Continuity|Patient Perceived Continuity of Care was assessed using Haggerty's measure of the same title. Role Continuity refers to the role of all clinicians being clear to the patient and to the providers on the treatment team. The possible range on this measure was between 6 and 30, and the analysis was conducted on the pre-post difference on this measure. More positive score indicated greater perceived role clarity and, when comparing pre and post score, a more positive score indicated greater improvement in perceived role clarity.|Baseline to 12-month follow-up|All participants who had a baseline and 12- month follow-up assessment of the Patient Perceived Continuity of Care from Multiple Clinicians.|||units on a scale||Standard Deviation|Mean
2581981|NCT02386189|Primary|Patient Perceived Continuity of Care From Multiple Clinicians - Informational Continuity|Patient Perceived Continuity of Care was assessed using Haggerty's measure of the same title. Informational Continuity refers to whether patients experienced communication failures between providers. The possible range on this measure was between 12 and 36. The analysis was conducted on the pre-post difference on Informational Continuity, subtracting the baseline score from the post-intervention score. For this measure a lower score and a decline between post intervention and baseline scores (or a negative value) indicates more positive outcomes.|Baseline to 12-month follow-up|All study participants with a baseline and 12-month follow-up assessment completed of Haggerty's Patient Perceived Continuity of Care from Multiple Clinicians.|||units on a scale||Standard Deviation|Mean
2581982|NCT02386189|Primary|Patient Perceived Continuity of Care From Multiple Providers- Management Continuity|Patient Perceived Continuity of Care was assessed using Haggerty's measure of the same title. Management continuity refers to the patient being able to identify one provider who is the main coordinator and assures all the links within the health care team. The possible range on this measure was between 5 and 40 and the analysis was conducted on the pre-post difference on Management Continuity, subtracting the baseline score from the post-intervention score. More positive score indicated greater perceived management continuity and greater improvement in perceived management continuity.|The time frame is from baseline assessment to 12 months post baseline during which at least one VA and one Community medical visit occurred.|All participants who completed the study and had both a baseline and 12-month follow-up assessment of Patient Perceived Continuity of Care from Multiple Providers. A positive score indicates improvement on this measure over the study period.|||units on a scale||Standard Deviation|Mean
2581983|NCT02386098|Secondary|Number of Participants With Emergence of HIV Drug Resistance-Stage 2|This end point was not evaluated, as the resulting information would only have been needed to help assess the risk for Stage 2 (which never opened due to the early termination of the study in Stage 1).|Up to Week 96|mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2581984|NCT02386098|Secondary|Number of Participants With Emergence of HIV Drug Resistance-Stage 1|Emergence of drug resistance was planned to be assessed using the most current version of International AIDS Society-United States of America (IAS-USA); however, it was not assessed due to the early termination of the study in Stage 1.|Up to Week 96|mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2581985|NCT02386098|Secondary|AUC(Tau) for BMS-955176-Stage 2|This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2588895|NCT02299934|Primary|The Percentage of Examinations With the Presence of Significant Artifacts Interfering Interpretation.||Day 1|Study was terminated prior to collecting any outcome measure data.||||||
2581986|NCT02386098|Secondary|Area Under the Concentration-time Curve in One Dosing Interval (AUC[Tau]) for BMS-955176-Stage 1|PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2581987|NCT02386098|Secondary|C0 for BMS-955176-Stage 2|This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2581988|NCT02386098|Secondary|Observed Pre-dose Plasma Concentration (C0) for BMS-955176-Stage 1|PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2581989|NCT02386098|Secondary|Ctau for BMS-955176-Stage 2|This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2581990|NCT02386098|Secondary|Observed Plasma Concentration at the End of a Dosing Interval (Ctau) for BMS-955176-Stage 1|PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2581991|NCT02386098|Secondary|Tmax for BMS-955176-Stage 2|This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2581992|NCT02386098|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) for BMS-955176-Stage 1|PK assessments were planned to be performed; however, it was not performed due to the early termination of the study in Stage 1.|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2581993|NCT02386098|Secondary|Cmax for BMS-955176-Stage 2|This end point was not evaluated, as the resulting information would only have been needed to help confirm the dose for Stage 2 (which never opened due to the early termination of the study in Stage 1).|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2581994|NCT02386098|Secondary|Maximum Observed Concentration (Cmax) for BMS-955176-Stage 1|The pharmacokinetic (PK) assessments were planned to be performed on PK Population, which comprised of all treated participants who had any available concentration-time data; however, it was not performed due to the early termination of the study in Stage 1.|Week 2 (pre-dose, 1, 2, 2.5, 3, 4, 4.5, 5, 6, 8, 12 hours post-dose and 24 hours [morning pre-dose])|PK Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2581995|NCT02386098|Secondary|Number of Participants With Occurrence of New AIDS Defining Events-Stage 2|This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.|Up to Week 96|mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2581996|NCT02386098|Secondary|Number of Participants With Occurrence of New Acquired Immunodeficiency Syndrome (AIDS) Defining Events-Stage 1|The occurrence of new AIDS defining events that is, Centers for Disease Control (CDC) Class C events in participants is presented.|Up to Week 96|mITT Population|||Participants|||Count of Participants
2581997|NCT02386098|Secondary|Number of Participants With SAEs and AELDs-Stage 2|This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.|Up to Week 96|mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2581998|NCT02386098|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Stage 1|An SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or medical events that may jeopardize the participant or require intervention (medical or surgical) to prevent one of the outcomes mentioned before. The number of participants with SAEs and AELDs are presented.|Up to Week 96|mITT Population|||Participants|||Count of Participants
2581999|NCT02386098|Secondary|Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 2|This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.|Baseline and up to Week 96|mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2582000|NCT02386098|Secondary|Change From Baseline in Percentage of CD4+ Cells Over Time-Stage 1|The percentage of CD4+ cells was assessed using flow cytometry. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point.|Baseline and up to Week 72|mITT Population (observed). Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).|||Percentage of CD4+ cells||Standard Deviation|Mean
2582001|NCT02386098|Secondary|Change From Baseline in CD4+ Cell Count Over Time-Stage 2|This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.|Baseline and up to Week 96|mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2582040|NCT02384993|Other Pre-specified|Vascular Endothelial Growth Factor|Levels of Vascular Endothelial Growth Factor will be assessed to identify changes in vascular health.|over 26 weeks (assessed at baseline visit and at week-26 visit|||||||
2582002|NCT02386098|Secondary|Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Count Over Time-Stage 1|The CD4+ cell count was assessed using flow cytometry. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point.|Baseline and up to Week 72|mITT Population (observed). Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Cells per microliter||Standard Deviation|Mean
2582003|NCT02386098|Secondary|Change From Baseline in log10 HIV-1 RNA Over Time-Stage 2|This end point was not evaluated in Stage 2 due to early termination of the study during Stage 1.|Baseline and up to Week 96|mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2582004|NCT02386098|Secondary|Change From Baseline in Logarithm to the Base 10 (log10) HIV-1 RNA Over Time-Stage 1|Blood samples were collected for analysis of HIV-1 RNA. Baseline is the last value on or before the start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Change from Baseline in plasma HIV-1 RNA (log10) is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). NA indicates data was not available. The standard deviation could not be calculated as a single participant was analyzed at the specified time point.|Baseline and up to Week 72|mITT Population (observed). Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles)|||log10 c/mL||Standard Deviation|Mean
2582005|NCT02386098|Secondary|Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 2|Blood samples were planned to be collected for quantitative analysis of plasma HIV-1 RNA. The analysis was not performed in Stage 2 due to early termination of the Study during Stage 1.|Weeks 24, 48 and 96|mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2582006|NCT02386098|Secondary|Percentage of Participants With HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96-Stage 1|Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Response was assessed using the last plasma HIV-1 RNA value in the predefined visit window to classify a participant's response status. The percentage of responders with HIV-1 RNA <200 c/mL at Weeks 24, 48 and 96 using mITT Population (observed) which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (October 10, 2016) is presented. The study was terminated early during the primary end point analysis of Stage 1; hence, data was not collected for Week 96 analysis.|Weeks 24, 48 and 96|mITT Population (observed). Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles)|||Percentage of participants||95% Confidence Interval|Number
2582007|NCT02386098|Secondary|Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 2|Blood samples were planned to be collected for quantitative analysis of plasma HIV-1 RNA. The analysis was not performed in Stage 2 due to early termination of the study during Stage 1.|Weeks 48 and 96|mITT Population (observed). Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2582008|NCT02386098|Secondary|Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Weeks 48 and 96-Stage 1|Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Response was assessed using the last plasma HIV-1 RNA value in the predefined visit window to classify a participant's response status. The percentage of responders with HIV-1 RNA <40 c/mL at Weeks 48 and 96 using mITT Population (observed) which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (October 10, 2016) is presented. The study was terminated early during the primary end point analysis of Stage 1; hence, data was not collected for Week 96 analysis.|Weeks 48 and 96|mITT Population (observed). Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Percentage of participants||95% Confidence Interval|Number
2582009|NCT02386098|Primary|Percentage of Participants With Plasma HIV-1 RNA <40 c/mL at Week 24-Stage 2|Blood samples were planned to be collected for quantitative analysis of plasma HIV-1 RNA. The analysis was not performed in Stage 2 due to early termination of the study during Stage 1.|Week 24|mITT Population. Data was not collected as no participants were enrolled in Stage 2 of the study.||||||
2582010|NCT02386098|Primary|Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <40 Copies Per Milliliter (c/mL) at Week 24-Stage 1|Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA <40 c/mL at Week 24 was assessed using the Food and Drug Administration (FDA) snapshot algorithm which used the last on-treatment plasma HIV-1 RNA measurement, within an FDA-specified visit window (18 to 30 weeks), to determine response. Analysis was performed on the modified intent to treat (mITT) Population which comprised of all randomized participants who received atleast one dose of BMS-955176 or TDF.|Week 24|mITT Population|||Percentage of participants||95% Confidence Interval|Number
2582011|NCT02385799|Secondary|Visual Analog Scale - Language/Communication Score|"The Visual Analog Scale measures the severity of three specific behavioral symptoms as reported by the parent/caregiver: Language/Communication, Anxiety/Obsessive Compulsive Behaviors, and Aggression/Hyperactivity/Hyperarousal. Caregivers mark on a visual line measuring 10 cm with worst behavior at 0 cm and best behavior at 10 cm. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the six-month visit. The calculated distance in cm between the marks drawn at the baseline and six-month visits thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the worst behavior side for the Language/Communication scale, at the six-month visit. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm."|At six-month visit|Placebo group: 5 discontinued treatment, 0 of whom returned to complete follow-up assessments, so 21 subjects were analyzed at follow-up. Sertraline group: 8 discontinued treatment, 2 of whom returned for an end-of-treatment visit, but due to time limitations only 1 of these 2 completed this assessment, so 25 subjects were analyzed at follow-up.|||centimeters||Standard Deviation|Mean
2582012|NCT02385799|Secondary|Visual Analog Scale - Language/Communication Score|"The Visual Analog Scale measures the severity of three specific behavioral symptoms as reported by the parent/caregiver: Language/Communication, Anxiety/Obsessive Compulsive Behaviors, and Aggression/Hyperactivity/Hyperarousal. Caregivers mark on a visual line measuring 10 cm with worst behavior at 0 cm and best behavior at 10 cm. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the six-month visit. The calculated distance in cm between the marks drawn at the baseline and six-month visits thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the worst behavior side for the Language/Communication scale, at baseline. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm."|At baseline visit|Placebo group: staff inadvertently neglected to administer this assessment to 1 subject's caregiver at baseline, so only 25 were completed. Sertraline group: staff inadvertently neglected to administer this assessment to 1 subject's caregiver at baseline, so only 31 were completed.|||centimeters||Standard Deviation|Mean
2582013|NCT02385799|Secondary|Clinical Global Impression Scale-Improvement (CGI-I)|The Clinical Global Impression-Improvement (CGI-I) is a 7-point scale completed by a clinician that yields a score measuring the overall behavioral change of an individual and their therapeutic response. The 7-point scale ranges from: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; and 7 = Very much worse. Therefore, the lower the score, the greater the behavioral improvement as rated by the clinician. The CGI-I was administered at the three-month and six-month visits. Shown here are the CGI-I mean scores from the 6-month follow-up visit.|At six-month visit|Placebo group: 5 discontinued treatment, 0 of whom returned to complete follow-up assessments, so 21 subjects were analyzed at follow-up. Sertraline group: 8 discontinued treatment, 2 of whom returned voluntarily to complete follow-up assessments, so 26 subjects were analyzed at follow-up.|||score on a scale||Standard Deviation|Mean
2582014|NCT02385799|Secondary|Clinical Global Impression Scale-Improvement (CGI-I)|The Clinical Global Impression-Improvement (CGI-I) is a 7-point scale completed by a clinician that yields a score measuring the overall behavioral change of an individual and their therapeutic response. The 7-point scale ranges from: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; and 7 = Very much worse. Therefore, the lower the score, the greater the behavioral improvement as rated by the clinician. The CGI-I was administered at the three-month and six-month visits. Shown here are the CGI-I mean scores from the 3-month follow-up visit.|At three-month visit|Placebo group: 3 discontinued treatment/become lost to follow-up prior to reaching 3-month visit, so 23 subjects were analyzed at this timepoint. Sertraline group: 5 discontinued treatment/become lost to follow-up prior to reaching 3-month visit, so 27 subjects were analyzed at this timepoint.|||score on a scale||Standard Deviation|Mean
2582015|NCT02385799|Secondary|Clinical Global Impression Scale-Severity (CGI-S)|The Clinical Global Impression-Severity (CGI-S) is a 7-point scale completed by a clinician that yields a rating of the patient's illness severity at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The 7-point scale ranges from: 1 = Normal; 2 = Borderline Ill; 3 = Mildly Ill; 4 = Moderately Ill; 5 = Markedly Ill; 6 = Severely Ill; and 7 = Extremely Ill. Therefore, the higher the score, the greater the severity of the patient's illness. The CGI-S was administered at baseline only for the purpose of characterizing the study population. Shown here are the CGI-S mean scores from the baseline visit.|At baseline visit||||score on a scale||Standard Deviation|Mean
2582016|NCT02385799|Secondary|Sensory Processing Measure-Preschool - Social Participation Raw Score|The Sensory Processing Measure-Preschool (SPM-P) is a questionnaire measuring specific problems, including under- and over-responsiveness, sensory-seeking behavior, and perceptual problems in multiple environments (at home, at school, and in the community) for children aged 2 to 5 years old, as reported by the parent/caregiver. The SPM-P provides norm-referenced standard scores for two higher-level integrative functions (praxis and social participation) and five sensor sensory systems (visual, auditory, tactile, proprioceptive, and vestibular functioning). Reported here is the Social Participation subscale mean raw score at the six-month visit, which ranges from 8 to 32. The lower the raw score, the more limited the child's level of social participation. The higher the score, the greater the child's level of social participation.|At six-month visit|Placebo group: 5 discontinued treatment, 0 of whom returned to complete follow-up assessments, so 21 subjects were analyzed at follow-up. Sertraline group: 8 discontinued treatment, 2 of whom returned for an end-of-treatment visit, but due to time limitations only 1 of these 2 completed this assessment, so 25 subjects were analyzed at follow-up.|||score on a scale||Standard Deviation|Mean
2582017|NCT02385799|Secondary|Sensory Processing Measure-Preschool - Social Participation Raw Score|The Sensory Processing Measure-Preschool (SPM-P) is a questionnaire measuring specific problems, including under- and over-responsiveness, sensory-seeking behavior, and perceptual problems in multiple environments (at home, at school, and in the community) for children aged 2 to 5 years old, as reported by the parent/caregiver. The SPM-P provides norm-referenced standard scores for two higher-level integrative functions (praxis and social participation) and five sensor sensory systems (visual, auditory, tactile, proprioceptive, and vestibular functioning). Reported here is the Social Participation subscale mean raw score at baseline, which ranges from 8 to 32. The lower the raw score, the more limited the child's level of social participation. The higher the score, the greater the child's level of social participation.|At baseline visit|Placebo group: staff inadvertently neglected to administer this questionnaire to 1 subject's caregiver at baseline, so only 25 were completed. Sertraline group: staff inadvertently neglected to administer this questionnaire to 1 subject's caregiver at baseline, so only 31 were completed.|||score on a scale||Standard Deviation|Mean
2582041|NCT02384993|Other Pre-specified|Brain Derived Neurotrophic Factor|The investigators will examine levels of Brain Derived Neurotrophic Factor to assess changes in blood neurotrophic levels.|over 26 weeks (assessed at baseline visit and at week-26 visit)|||||||
2582042|NCT02384993|Other Pre-specified|Cardiorespiratory Fitness Measured by Peak Oxygen Consumption (VO2peak)|The investigators will examine Cardiorespiratory Fitness by measuring VO2peak on a graded treadmill test - after participants fasted for 12-hours.|over 26 weeks (assessed at baseline visit and at week-26 visit)||||mL/kg/min||Standard Error|Mean
2582043|NCT02384993|Other Pre-specified|Ancillary Neuroimaging Measures|Ancillary neuroimaging measures include MRI brain scans of blood flow and brain structure.|over 26 weeks (assessed at baseline visit and at week-26 visit)|||||||
2582018|NCT02385799|Secondary|Preschool Language Scale-Fifth Edition - Total Language Raw Score|The Preschool Language Scale-Fifth Edition (PLS-5) is designed to measure auditory comprehension (AC) and expressive communication (EC) for children from birth to 7 years 11 months. The measure examines the child's attention, play, gestures, social communication, semantics, language structure, integrative language skills and emergent literacy skills. The PLS-5 has expanded coverage of early play behaviors, concepts, theory of mind, and emergent literacy skills. The PLS-5 yields norm-referenced scores including standard scores, percentile ranks and age equivalents for the AC and EC scales as well as for Total Language (TL). Raw score ranges are 0 to 65 in AC, 0 to 67 in EC, and therefore 0 to 132 in TL (calculated by summing AC+EC raw scores). The higher the scores, the greater the language ability. Shown here are the mean TL raw scores from the six-month visit.|At six-month visit|Placebo group: 5 discontinued treatment, 0 of whom returned to complete follow-up assessments, so 21 subjects were analyzed at follow-up. Sertraline group: 8 discontinued treatment, 2 of whom returned for an end-of-treatment visit, but due to time limitations only 1 of these 2 completed this assessment, so 25 subjects were analyzed at follow-up.|||score on a scale||Standard Deviation|Mean
2582019|NCT02385799|Secondary|Preschool Language Scale-Fifth Edition - Total Language Raw Score|The Preschool Language Scale-Fifth Edition (PLS-5) is designed to measure auditory comprehension (AC) and expressive communication (EC) for children from birth to 7 years 11 months. The measure examines the child's attention, play, gestures, social communication, semantics, language structure, integrative language skills and emergent literacy skills. The PLS-5 has expanded coverage of early play behaviors, concepts, theory of mind, and emergent literacy skills. The PLS-5 yields norm-referenced scores including standard scores, percentile ranks and age equivalents for the AC and EC scales as well as for Total Language (TL). Raw score ranges are 0 to 65 in AC, 0 to 67 in EC, and therefore 0 to 132 in TL (calculated by summing AC+EC raw scores). The higher the scores, the greater the language ability. Shown here are the mean TL raw scores from the baseline visit.|At baseline visit|Sertraline group: 2 subjects were completely nonverbal at baseline, so the rater determined that their assessments could not be completed; therefore, only 30 subjects in this arm were analyzed at baseline.|||score on a scale||Standard Deviation|Mean
2582020|NCT02385799|Secondary|Preschool Anxiety Scale-Revised - Total Score|Preschool Anxiety Scale-Revised (PAS-R) is a questionnaire designed to assess symptoms of anxiety and fears in young children aged 6 and below as reported by their parents. The PAS-R consists of 34 questions, each with a rating option of 0 to 4 where 0=not true at all, 1=seldom true, 2=sometimes true, 3=quite often true, and 4=very often true. The total score is calculated as the sum of all responses and therefore ranges from 0 to 136. Lower scores indicate less anxiety/fear; higher scores indicate more anxiety/fear. Reported here are the mean total scores for the placebo and treatment groups at the six-month visit.|At six-month visit|Placebo group: 5 discontinued treatment, 0 of whom returned to complete follow-up assessments, so 21 subjects were analyzed at follow-up. Sertraline group: 8 discontinued treatment, 2 of whom returned voluntarily to complete follow-up assessments, so 26 subjects were analyzed at follow-up.|||score on a scale||Standard Deviation|Mean
2582021|NCT02385799|Secondary|Preschool Anxiety Scale-Revised - Total Score|Preschool Anxiety Scale-Revised (PAS-R) is a questionnaire designed to assess symptoms of anxiety and fears in young children aged 6 and below as reported by their parents. The PAS-R consists of 34 questions, each with a rating option of 0 to 4 where 0=not true at all, 1=seldom true, 2=sometimes true, 3=quite often true, and 4=very often true. The total score is calculated as the sum of all responses and therefore ranges from 0 to 136. Lower scores indicate less anxiety/fear; higher scores indicate more anxiety/fear. Reported here are the mean total scores for the placebo and treatment groups at baseline.|At baseline visit|Placebo group: staff inadvertently neglected to administer this questionnaire to the 2 subjects' caregivers at baseline, so only 24 were completed.|||score on a scale||Standard Deviation|Mean
2582022|NCT02385799|Secondary|Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score|The Vineland-II measures the personal and social skills of individuals from birth through adulthood. It was designed to assess handicapped and non-handicapped persons in their personal and social functioning and is appropriate for individuals of all ages. The Vineland-II is a survey that is administered to a parent or caregiver using a semi-structured interview format and is organized around four Behavior Domains: Communication, Daily Living Skills, Socialization, and Motor Skills. Each subtest is scored with a standard score X=100 ± 15 and summed to calculate the Adaptive Behavior Composite (ABC) using age-adjusted scoring tables. Reported here are the ABC mean standard scores for the placebo and treatment groups at the six-month visit. The ABC ranges from 20 to 160 and indicates low (20-70), moderately low (70-85), adequate (85-115), moderately high (115-130), or high (130-160) overall adaptive functioning.|At six-month visit|Placebo group: 5 discontinued treatment, 0 of whom returned to complete follow-up assessments, so 21 subjects were analyzed at follow-up. Sertraline group: 8 discontinued treatment, 2 of whom returned for an end-of-treatment visit, but due to time limitations only 1 of these 2 completed this assessment, so 25 subjects were analyzed at follow-up.|||score on a scale||Standard Deviation|Mean
2582023|NCT02385799|Secondary|Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score|The Vineland-II measures the personal and social skills of individuals from birth through adulthood. It was designed to assess handicapped and non-handicapped persons in their personal and social functioning and is appropriate for individuals of all ages. The Vineland-II is a survey that is administered to a parent or caregiver using a semi-structured interview format and is organized around four Behavior Domains: Communication, Daily Living Skills, Socialization, and Motor Skills. Each subtest is scored with a standard score X=100 ± 15 and summed to calculate the Adaptive Behavior Composite (ABC) using age-adjusted scoring tables. Reported here are the ABC mean standard scores for the placebo and treatment groups at baseline. The ABC ranges from 20 to 160 and indicates low (20-70), moderately low (70-85), adequate (85-115), moderately high (115-130), or high (130-160) overall adaptive functioning.|At baseline visit||||score on a scale||Standard Deviation|Mean
2582044|NCT02384993|Secondary|Change in Hippocampal Volume|Hippocampal volume will be assessed using T1-weighted 3T MRI images.|up to 26 weeks (assessed at baseline and 26 weeks)||2020-07-31|07/2020||||
2582045|NCT02384993|Secondary|Change in Profile of Mood States (POMS) Score|The Profile of Mood States was used to assess mood. Scores range from -32 to 200. Higher scores indicate more mood disturbance.|up to 26 weeks (assessed at baseline and 26 weeks)||2020-07-31|07/2020||||
2588896|NCT02299934|Primary|Detection Rates of the Variations of the Liver Blood Supply||Day 1|Study was terminated prior to collecting any outcome measure data.||||||
2582024|NCT02385799|Primary|Change in Mullen Scales of Early Learning - Combined Age Equivalent Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the baseline and 6-month follow-up combined age equivalent scores, calculated as the sum of the age equivalent scores from each scale. The combined score ranges from 0 to 280. The lower the score on this scale, the weaker the ability; the higher the score, the greater the ability. The MSEL was administered at the baseline visit and at the 6-month follow-up visit.|From baseline visit to six-month visit|Placebo group: 5 discontinued treatment, 0 of whom returned to complete follow-up assessments, so 21 subjects were analyzed at follow-up. Sertraline group: 8 discontinued treatment, 2 of whom returned voluntarily to complete follow-up assessments, so 26 subjects were analyzed at follow-up.|||score on a scale||Standard Deviation|Mean
2582025|NCT02385799|Primary|Change in Mullen Scales of Early Learning - Expressive Language Raw Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the baseline and 6-month follow-up raw scores from the expressive language scale. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the ability; the higher the score, the greater the ability. The MSEL was administered at the baseline visit and at the 6-month follow-up visit.|From baseline visit to six-month visit|Placebo group: 5 discontinued treatment, 0 of whom returned to complete follow-up assessments, so 21 subjects were analyzed at follow-up. Sertraline group: 8 discontinued treatment, 2 of whom returned voluntarily to complete follow-up assessments, so 26 subjects were analyzed at follow-up.|||score on a scale||Standard Deviation|Mean
2582026|NCT02385721|Secondary|Treatment Persistence Rate of Fimasartan|Treatment persistence rate of Kanarb tablet® (fimasartan) until the end of 1-year study|up to 12 months||||Participants|||Count of Participants
2582027|NCT02385721|Primary|Number of Participants Experiencing AEs or ADRs|Number of participants experiencing AEs (or ADRs) during the study|up to 12 months||||Participants|||Count of Participants
2582028|NCT02385708|Primary|Incidence of Surgical Site Infections|Number of participants who had surgical site infection development at 30 day post operative visit based on Center for Disease Control Criteria for Defining A Surgical Site Infection (SSI), 2011.|30 days||||Participants|||Count of Participants
2582029|NCT02385669|Secondary|Epitope Spreading (Epitope-spreading for CD8+ T Cells in the Blood and the Sentinel Immunized Node)|An evaluation of epitope-spreading for CD8+ T cells in the blood and the sentinel immunized node that are reactive to a panel of defined melanoma antigens.|through day 92||2019-12-31|12/2019||||
2582030|NCT02385669|Primary|CD4+ T Cell Responses in the Blood and in the Sentinel Immunized Node|"CD4+ T cell responses to the peptide vaccine, defined as:~any CD4+ T cell response to 6 melanoma helper peptides (6MHP) in peripheral blood mononuclear cells (PBMC) with a 10 fold (or greater) increase in response over background (high response) by ex vivo ELIspot assay.~CD4+ T cell high responses to 6MHP in PBMC at at least 2 consecutive time points having peripheral blood mononuclear cells (PBMC) with a 10 fold (or greater) increase in response over background by ex vivo ELIspot assay.~CD4+ T cell high response to 6MHP in sentinel immunized lymph node (SIN)."|through day 92||||Participants|||Count of Participants
2582031|NCT02385669|Primary|Safety (Adverse Event Profile)|Adverse event profile for the combination of ipilimumab and 6MHP|30 days after the last vaccination|All eligible enrolled and treated patients. Partiipants analyzed for any adverse event (AE) and for dose limiting toxicities (DLT).|||Participants|||Count of Participants
2582032|NCT02385526|Primary|Percent Patients Reaching the Defined Target Dose|Determination of the proportion (percent) of patients in each VNS Therapy titration group reaching the defined target dose within clinically defined titration time-frame|12 weeks post implant|Population of subjects implanted with Vagus Nerve Therapy generator who received stimulation via left, tenth cranial nerve at varying dosing methods (device settings adjustments) depending on the group each subject was randomized. All subject had a common, final target dose to achieve but used alternate methods to achieve the target dose.|||Participants|||Count of Participants
2582033|NCT02385084|Primary|PK: Maximum Plasma Concentration (Cmax) of LY2409021||Day 1: Predose, 0.5 H, 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period|All participants who received the LY2409021 formulation and had evaluable Cmax values. PK data for 1 participant who met study exclusion criteria was excluded from analyses. This participant only received the capsule formulation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2582034|NCT02385084|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of LY2409021||Day 1: Predose, 0.5 Hours (H), 1 H, 4 H, 8 H, 12 H, 24 H, 48 H, 72 H, 96 H, 144 H, 192 H, 264 H, 336 H Postdose in Each Period|All participants who received the LY2409021 formulation and had evaluable AUC(0-inf) values. PK data for 1 participant who met study exclusion criteria was excluded from analyses. This participant only received the capsule formulation.|||nanograms x hours/milliliters (ng•h/mL||Geometric Coefficient of Variation|Geometric Mean
2582035|NCT02384993|Other Pre-specified|Moderate to Vigorous Physical Activity (MVPA)|Participants wore a triaxial accelerometer (GT3X+, Actigraph LLC, Pensacola, FL) for seven consecutive days to record free-living physical activity before and after the intervention.|up to 26 weeks (assessed at baseline and 26 weeks)||||minute/day||Standard Deviation|Mean
2582036|NCT02384993|Other Pre-specified|Sedentary Behavior Measured Via Accelerometer|Participants wore a triaxial accelerometer (GT3X+, Actigraph LLC, Pensacola, FL) for seven consecutive days to record free-living PA and sedentary behavior before and after the intervention.|up to 26 weeks (measured at baseline and 26 weeks)||||minute/day||Standard Deviation|Mean
2582037|NCT02384993|Other Pre-specified|Endothelial Function|Endothelial function changes will be assessed via ultrasound using Brachial Artery Reactivity Testing.|over 26 weeks (assessed at baseline visit and at week-26 visit)|||||||
2582038|NCT02384993|Other Pre-specified|Subclinical Atherosclerosis Burden|Changes in subclinical atherosclerosis burden will be measured using Carotid Intima-Media Thickness Ultrasound.|over 26 weeks (assessed at baseline visit and at week-26 visit)|||||||
2582039|NCT02384993|Other Pre-specified|Arterial Plaque Presence|Changes in plaque presence will be measured using Comprehensive Carotid Ultrasound.|over 26 weeks (assessed at baseline visit and at week-26 visit)|||||||
2582046|NCT02384993|Secondary|Change in California Verbal Learning Test-II Long Delay Score|The California Verbal Learning Test-II assesses cognitive function. Long delay is a test where there is a 20 minute time period between initial word list presented and recall. Higher scores indicate more words recalled. Scores range from 0 to 20.|over 26 weeks (assessed at baseline visit and at week-26 visit)||||words||Standard Deviation|Mean
2582047|NCT02384993|Secondary|Change in Mini Mental State Examination (MMSE) Score|The Mini Mental State Examination (MMSE) measures global cognitive function. Scores range from 0 to 30. Higher scores indicate better cognitive function.|up to 26 weeks (assessed at baseline and 26 weeks)||||scores on a scale||Standard Deviation|Mean
2582048|NCT02384993|Secondary|Change in Delis-Kaplan Executive Function System Color Word Interference (D-KEFS CWI) Score|The D-KEFS CWI will be used to measure executive function. Lower times indicate improved executive function. Scores range from 0 to 90.|up to 26 weeks (measured at baseline and 26 weeks)||||seconds||Standard Deviation|Mean
2582049|NCT02384993|Secondary|Change in California Verbal Learning Test-II Total Score|The California Verbal Learning Test-II assesses cognitive function. Higher scores indicate more words recalled. Scores range from 0 to 100.|over 26 weeks (assessed at baseline visit and at week-26 visit)||||words||Standard Deviation|Mean
2582050|NCT02384993|Secondary|Ultrasound-Measured Cerebral Blood Flow|Cerebral blood flow velocity changes in the middle cerebral artery will be measured using Transcranial Doppler ultrasound imaging.|over 26 weeks (assessed at baseline visit and at week-26 visit)||2020-07-31|07/2020||||
2582051|NCT02384993|Primary|Change in Cerebral Glucose Metabolism as Measured by FDG PET Scanning|Changes in cerebral glucose metabolism will be assessed using fluorodeoxyglucose (FDG) positron emission tomography (PET) scanning. This method measures the brain's use of blood sugar while in a resting state. Measurements were taken in the posterior cingulate cortex (PCC). An increase in this measure indicates an increase in the brain's uptake and usage of blood sugar.|over 26 weeks (assessed at baseline visit and at week-26 visit)||||arbitrary units||Standard Deviation|Mean
2582052|NCT02384993|Primary|Feasibility: Percentage of Participants Who Completed the Study|Feasibility is in part defined as at least 90% of enrolled participants completed the study.|up to 3 years||||Participants|||Count of Participants
2582053|NCT02384993|Primary|Acceptability: Percentage of Sessions Completed by Enhanced Physical Activity Group|This intervention will be considered acceptable if participants who complete the Enhanced Physical Activity intervention, complete ≥80% of scheduled training sessions.|up to 26 weeks||||Percentage of Sessions||Standard Deviation|Mean
2582054|NCT02384941|Secondary|Percent Change From Baseline in Body Weight at Week 24|Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative percent change from baseline indicates a loss in body weight from baseline to Week 24.|Baseline to Week 24|"Analysis performed on mITT analysis set. Here, Overall Number of Participants Analyzed signified participants with available data for this outcome measure."|||percent change||Standard Error|Least Squares Mean
2582055|NCT02384941|Secondary|Change From Baseline in Diabetes Distress Scores as Measured by 2-item Diabetes Distress Screening Scale (DDS2) Scores at Week 24|The DDS2 is a 2-item diabetes distress screening instrument where respondents rated, on a 6-point scale, the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen using a 6-point scale: where 1=no distress to 6=severe distress for a total possible score of 2 (not a problem) to 12 (very serious problem), with higher score corresponding to higher distress. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicates improvement.|Baseline to Week 24|"Analysis performed on mITT analysis set. Here, Overall Number of Participants Analyzed signified participants with available data for this outcome measure."|||units on a scale||Standard Error|Least Squares Mean
2582056|NCT02384941|Secondary|Change From Baseline in Diabetes Total Treatment Satisfaction Scores as Measured by Total Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Scores at Week 24|DTSQs is a diabetes-specific measure used to evaluate overall treatment satisfaction and perception of hyperglycemia and hypoglycemia events. It consists of 8 items and the response categories for all items were on a 7-point likert scale.The DTSQs response options ranged from 0 (very dissatisfied) to 6 (very satisfied). Responses to item 1, 4, 5, 6, 7 and 8 were summarized to determine the total treatment satisfaction score which ranged from 0 (very dissatisfied) to 36 (very satisfied), with a higher score corresponding to higher satisfaction . LS means were obtained from MMRM model including all available post baseline values. A positive change from baseline indicates improvement.|Baseline to Week 24|"Analysis performed on mITT analysis set. Here, Overall Number of Participants Analyzed signified participants with available data for this outcome measure."|||units on a scale||Standard Error|Least Squares Mean
2582057|NCT02384941|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicates a lower glucose at Week 24 compared to baseline.|Baseline to Week 24|"Analysis performed on mITT analysis set. Here, Overall Number of Participants Analyzed signified participants with available data for this outcome measure."|||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
2582058|NCT02384941|Secondary|Change From Baseline in Mean Daily Bolus Insulin Dose at Week 24|The mean bolus insulin dose in international units per day (IU/day) for Week 24 was the average over the 3 to 5 days prior to the Week 24 visit. The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post Baseline values. A negative change from Baseline indicated a reduction in the amount of bolus insulin used between Baseline and Week 24.|Baseline to Week 24|Analysis performed on mITT analysis set. Here, “Overall Number of Participants Analyzed” signified participants with available data for this outcome measure.|||IU/day||Standard Error|Least Squares Mean
2582059|NCT02384941|Secondary|Absolute Change From Baseline in Body Weight at Week 24|Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative change from Baseline indicates a loss in body weight from Baseline to Week 24.|Baseline to Week 24|Analysis performed on mITT analysis set. Here, “Overall Number of Participants Analyzed” signified participants with available data for this outcome measure.|||kilograms (kg)||Standard Error|Least Squares Mean
2582060|NCT02384941|Secondary|Percentage of Participants With A1C <7.0% (at Week 24) and No Episode of Severe Hypoglycemia and No Episode of Diabetic Ketoacidosis (DKA) Upto Week 24|Blood samples were collected for the assessment of Hemoglobin A1C to determine the participants with A1C value <7.0%. A central blinded adjudication process determined whether participants experienced either DKA or Severe Hypoglycemia. Only positively adjudicated severe hypoglycemia and diabetic ketoacidosis were included in the analysis.|Baseline to Week 24|Analysis performed on mITT analysis set.|||percentage of participants|||Number
2582061|NCT02384941|Primary|Change From Baseline in A1C at Week 24|Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least square (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) that included fixed, categorical effects of treatment, randomization strata of insulin delivery method (MDI, CSII), randomization strata of Week -2 A1C (<= 8.5%, >8.5%), time (study week), a treatment-by-time interaction, and baseline A1C-by-time interaction as a covariate. A negative change from Baseline (a lower A1C value at Week 24) indicates an improvement.|Baseline to Week 24|"Modified intent to treat (mITT) analysis set included all randomly assigned participants who have taken at least 1 dose of study drug. Here, Overall Number of Participants Analyzed signified participants with available data for this outcome measure."|||percentage of A1C||Standard Error|Least Squares Mean
2582062|NCT02384538|Secondary|Patient Global Assessment of Hand Osteoarthritis (OA) Status by NRS-11: Change From Baseline to Each Visit|"Participants were asked how much they were affected by hand OA by responding to the question Considering all the ways your hand OA affects you, how have you been during the last 48 hours? using an 11-point scale (NRS-11). Scores range from 0 to 10 points, with higher scores indicating greater effect of hand OA on the participant. A decrease in the NRS-11 score represents an improvement the effect of hand OA on the participant."|Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26|All participants in the mITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2582063|NCT02384538|Secondary|Participant Assessment of Index Hand Pain Intensity Using Numeric Rating Scale (NRS-11): Change From Baseline to Each Visit|Participants rated the pain intensity of each hand during the previous 48 hours using an 11-point scale (NRS-11). The change from baseline to each visit in NRS-11 in the index hand (the hand with the most disease) are presented. Scores range from 0 to 10 points, with higher scores indicating greater pain intensity. A decrease in the NRS-11 score represents a decrease in pain intensity.|Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26|All participants in the mITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2582064|NCT02384538|Secondary|Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Total Score: Change From Baseline to Each Visit|The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The total score ranges from 0 to 150; lower scores indicate better status. A decrease in the total score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.|Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26|All participants in the mITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2582065|NCT02384538|Secondary|Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Stiffness Subdomain Score: Change From Baseline to Each Visit|The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The stiffness subdomain score ranges from 0 to 10; lower scores indicate better status. A decrease in the stiffness subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.|Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26|All participants in the mITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2582066|NCT02384538|Secondary|Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Physical Function Subdomain Score: Change From Baseline to Each Visit|The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The physical function subdomain score ranges from 0 to 90; lower scores indicate better status. A decrease in the physical function subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.|Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26|All participants in the mITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2582067|NCT02384538|Secondary|Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Each Visit|The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The pain subdomain score ranges from 0 to 50; lower scores indicate better status. A decrease in the pain subdomain score represents improvement in status. LOCF: Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.|Week 0 (Baseline) and Weeks 2, 4, 8, 12, 16, 20, and 26|All participants in the mITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2582068|NCT02384538|Primary|Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16|The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The pain subdomain score ranges from 0 to 50; lower scores indicate better status. A decrease in the pain subdomain score represents improvement in status. Last Observation Carried Forward (LOCF): Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.|Week 0 (Baseline), Week 16|mITT population: all randomized participants who received at least 1 dose of study drug.|||units on a scale||95% Confidence Interval|Least Squares Mean
2582081|NCT02384200|Secondary|Number of Participants With Postoperative Urinary Tract Infection (UTI)|symptomatic urinary tract infection|Within 12 weeks following day of surgery||||Participants|||Count of Participants
2582069|NCT02384460|Secondary|Change From Baseline In Pain Score At Day 7|"Change in pain assessed at Day 7 compared to baseline was measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) behavioral scale for participants 1 month to 3 years of age. Each of the 5 FLACC categories was scored from 0 to 2, which resulted in a total score between 0 and 10 with 0=Relaxed and comfortable, 1 to 3=Mild discomfort, 4 to 6=Moderate pain, and 7 to 10=Severe discomfort/pain. For participants 4 years of age and older, the Wong Faces Pain Scale was used. This scale shows a series of faces ranging from a happy face at 0, which represents no hurt, to a crying face at 10, which represents hurts worst. Pain scores were categorized into 3 groups based on improvement: Improved or No Pain, Not Improved, and Missing. A pain score reduction from baseline greater than or equal to 2 points on the scale was classed as improved."|Baseline, Day 7|Analysis was performed on the ITT population. The ITT population included all randomized participants.|||units on a scale||Standard Deviation|Mean
2582070|NCT02384460|Secondary|Change From Baseline In Itching Score At Day 7|Itching was assessed using the 5-point Itch Man Pruritus Assessment Tool. For participants up to 5 years of age, itching was assessed using caretaker's response and participants 6 years of age and older self-reported their itching assessments based on the following scores: 0=Comfortable, no itch; 1=itches a little, does not interfere with activity; 2=itches more, sometimes interferes with activity; 3=itches a lot, difficult to be still, concentrate; 4=itches most terribly, impossible to sit still or concentrate. Itching scores were categorized into 3 groups based on improvement; Improved or No Itching, Not Improved, and Missing. An itching score reduction from baseline greater than or equal to 1 point on the scale was classed as improved.|Baseline, Day 7|Analysis was performed on the ITT population. The ITT population included all randomized participants.|||units on a scale||Standard Deviation|Mean
2582071|NCT02384460|Secondary|Change From Baseline In BSAI Of Total Body Wound Burden At Month 3 Visit|Total body wound burden was calculated using BSAI. A wound defined as an open area on the skin (that is, epidermal covering disrupted). BSAI was calculated as a percentage, ranging from 0% to 100%, of affected body surface area, recorded for each defined body region (that is, head/neck, upper limbs, lower limbs, trunk [includes groin]), and multiplied by the weighting factor, then summed for all body regions.|Baseline, Month 3 visit|Analysis was performed on the ITT population. The ITT population included all randomized participants.|||Percentage change in BSAI||Standard Error|Least Squares Mean
2582072|NCT02384460|Secondary|Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin At Month 3 Visit|Lesional skin was defined as areas that contained any of the following: blisters, erosions, ulcerations, scabbing, bullae, or eschars, as well as areas that were weeping, sloughing, oozing, crusted, or denuded. BSAI was calculated as a percentage, ranging from 0% to 100%, of affected body surface area, recorded for each defined body region (that is, head/neck, upper limbs, trunk [includes groin], and lower limbs), multiplied by the weighting factor, then summed for all body regions.|Baseline, Month 3 visit|Analysis was performed on the ITT population. The ITT population included all randomized participants.|||Percentage change in BSAI||Standard Error|Least Squares Mean
2582073|NCT02384460|Secondary|Percentage Of Participants Experiencing Complete Closure Of Their Target Wound At Month 1 And Month 2 Visits|Target wounds were monitored at each study visit for complete closure, defined as skin re-epithelialization without drainage. The percentage of participants who completed target wound closure at the Month 1 and Month 2 study visits is displayed. If a target wound was documented to have closed at a given visit, it was considered closed at all subsequent visits.|From baseline to Month 1 and Month 2 visits|Analysis was performed on participants from the ITT population with post-baseline wound closure data.|||percentage of participants|||Number
2582074|NCT02384460|Primary|The Percentage Of Participants Experiencing Complete Closure Of Their Target Wound Within 3 Months|Target wounds were monitored at each study visit for complete closure, defined as skin re-epithelialization without drainage. Participants were considered responders if they experienced complete wound closure at the Week 2 or Months 1, 2, or 3 visits. If a target wound was documented to have closed at a given visit, it was considered closed at all subsequent visits. This primary end point displays the percentage of participants from the ITT population who had complete target wound closure by the end of the study period (that is, 3 months). Analysis was performed on participants with post-baseline wound closure data.|From baseline to Month 3 visit|ITT population with post-baseline wound closure data and whose target wound had closed within 3 months.|||percentage of participants|||Number
2582075|NCT02384460|Primary|Time To Complete Target Wound Closure Within 3 Months|Target wounds were monitored at each study visit for complete closure, defined as skin re-epithelialization without drainage. Time to target wound closure was measured from the date of the first administration of the study drug to the date of target wound closure. Participants were censored if they did not have a response within 3 months, or withdrew earlier before the confirmation of their target wound closing. This primary end point displays the mean time to complete target wound closure, analyzed using a Kaplan-Meier approach.|From baseline to Month 3 visit|ITT population with post-baseline wound closure data and whose target wound had closed within 3 months.|||days||Standard Deviation|Mean
2582076|NCT02384200|Secondary|Number of Partcipants That Were Stone Free After Surgery|the absence of stone fragments >2mm on postoperative imaging following kidney stone surgery (PCNL)|Within 12 weeks following day of surgery||||Participants|||Count of Participants
2582077|NCT02384200|Secondary|Hospital Length of Stay After Surgery|Number of days in a hospital setting after kidney stone surgery (defined as number of midnights in hospitalization)|Within 12 weeks following day of surgery||||days||Standard Deviation|Mean
2582078|NCT02384200|Secondary|Number and Grade of Postoperative Complications Following Surgery as Graded by the Clavien-Dindo Complication Scale|The Clavien-Dindo grading scale, originally described in 2004, is a widely used throughout surgery to grade adverse events (i.e. complications) which occur as a result of surgical procedures; it is used in most urology units and has become the standard classification system for many surgical specialities. The grading system uses a Grade I - Grade V scale, with Grade V being the most severe.|Within 12 weeks following day of surgery||||participants|||Number
2582079|NCT02384200|Secondary|Number of Participants Admitted to Intensive Care Unit (ICU) After Surgery|admission to ICU level nursing unit during primary hospitalization following kidney stone surgery (PCNL).|within 7 days following day of surgery||||Participants|||Count of Participants
2582080|NCT02384200|Secondary|Number of Participants With a Postoperative Fever Greater Than 38.3 Celsius|Body temperature >= 38.3 degrees Celsius|within 7 days following day of surgery||||Participants|||Count of Participants
2582085|NCT02384200|Primary|Number of Participants That Developed Sepsis After Surgery|"Sepsis will be defined by the 2012 International Guidelines for Management of Severe Sepsis and Septic Shock where 2 or more of the following variables are present and temporally associated~Temp > 38.3 C or <36 C~Heart Rate > 90/min (at least 12 hrs after surgery)~Respiratory Rate > 20/min (at least 12 hrs after surgery)~Altered mental status: defined as lack of orientation to either name, place, or time/date.~Systolic Blood Pressure (SBP) < 90 mmHg, Mean Arterial Pressure < 70 mmHg, or SBP decrease >40 mmHg in adults~WBC >12000 or < 4000"|Within 7 days following day of surgery||||Participants|||Count of Participants
2582086|NCT02384096|Primary|Number of Participants With Paresthesia Coverage ≥50%|Paresthesia Coverage assesses how much of the subject's painful areas are covered by SCS-induced paresthesia. The number of subjects reporting paresthesia coverage ≥50% is reported.|7, 14 days post activation|All subjects who completed the day 7 and day 14 post-activation study visits were included. Statistical analysis was not performed as the sample size is too small to draw any statistically relevant conclusions.|||Participants|||Number
2582087|NCT02384070|Secondary|Sub-clinical Ischemic Events Measured by Troponin Levels Post-procedure||48 hours post procedure||||participants|||Number
2582088|NCT02384070|Secondary|TIMI (Thrombolysis in Myocardial Infarction) Major and Minor Bleeding Scores|"Major: Intracranial bleeding, Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL or a ≥15% absolute decrease in haematocrit or Fatal bleeding.~Minor: Clinically overt (including imaging), resulting in hemoglobin drop of 3 to <5 g/dL or ≥10% decrease in haematocrit. No observed blood loss: ≥4 g/dL decrease in the haemoglobin concentration or ≥12% decrease in haematocrit Any overt sign of hemorrhage that meets one of the following criteria and does not meet criteria for a major or minor bleeding event, as defined above Requiring intervention"|Hospital Stay and after 30 days post PCI||||Patients|||Number
2582089|NCT02384070|Primary|Thrombotic Complications||Hospital Stay and after 30 days post PCI||||Number of Patients|||Number
2582090|NCT02384044|Secondary|Change From Baseline for Air Challenge|The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure.|1 Day|Thirty (30) subjects received study product and completed the study.|||Units on a scale||Standard Deviation|Mean
2582091|NCT02384044|Primary|Change From Baseline Visual Analog Scale|Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline.|1 Day|Thirty (30) subjects received study products and completed the study.|||Units on a scale||Standard Deviation|Mean
2582092|NCT02383966|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Emergent Adverse Events Leading to Death and AEs Leading to Discontinuation|An Adverse event (AE) was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug that were absent before treatment or that worsened relative to pre-treatment state up to 30 days after last administration. TEAEs included both Serious TEAEs and non-serious TEAEs.|Time from date of randomization up to data cutoff (assessed up to 904 days)|Safety analysis set included all participants who had received at least 1 dose of any trial treatment.|||Participants|||Count of Participants
2582093|NCT02383966|Secondary|Duration of Response (DOR)|DOR was determined for participants whose BOR was either CR or PR. It was defined as the time from the first assessment of CR or PR until the event defining PFS time. PFS time was defined as the time in months from the date of randomization until first observation of PD (based on imaging as assessed by IRC), or death due to any cause when death occurs within 60 days after the last tumor assessment or randomization (whichever is later). CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)|ITT analysis set included all participants who were randomized to study treatment.|||Weeks||95% Confidence Interval|Median
2582094|NCT02383966|Secondary|Disease Control Rate (DCR)|The DCR was based on imaging and classified according to RECIST Version 1.1 criteria. The DCR was defined as the number of participants whose Best Overall Response is either CR, PR or stable disease (SD), divided by the number of participants belonging to the trial set of interest multiplied by 100. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on trial.|Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)|ITT analysis set included all participants who were randomized to study treatment.|||percentage of participants||95% Confidence Interval|Number
2582104|NCT02383862|Secondary|Percentage of Participants With Medications Ordered for SPADE Symptoms at Baseline Clinic Visit|Electronic medical records were reviewed to determine the number of medications ordered for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0, 1, 2, or 3≤ medications ordered for SPADE symptoms at baseline was calculated.|baseline|Participants whose electronic medical record of the baseline clinic visit was available for review|||percentage of participants|||Number
2582095|NCT02383966|Secondary|Best Overall Response Rate (ORR)|The Best ORR was based on imaging and classified according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria. The BOR rate was defined as the number of participants whose BOR was either complete response (CR) or partial response (PR), relative to the number of participants belonging to the trial set of interest. CR was defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must had reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)|ITT analysis set included all participants who were randomized to study treatment.|||percentage of participants||95% Confidence Interval|Number
2582096|NCT02383966|Secondary|Overall Survival (OS) Time|The OS time was defined as the time from randomization to the date of death. If a participant was alive at the time of analysis, survival time was censored at the last date when the participant was known to be alive. If this date was after data cut-off, participants were censored at the date of data cut-off. OS was measured using Kaplan-Meier (KM) estimates.|Time from date of randomization up to data cutoff (assessed up to 904 days)|ITT analysis set included all participants who were randomized to study treatment.|||months||95% Confidence Interval|Median
2582097|NCT02383966|Secondary|Progression-free Survival (PFS) Time, as Assessed by the Investigator|PFS time was defined as the time in months from the date of randomization until first observation of PD (radiologically confirmed by Investigator), or death due to any cause when death occurs within 60 days after the last tumor assessment or randomization (whichever is later). PD is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must also demonstrate an absolute increase of at least 5 millimeter. PFS was measured using Kaplan-Meier (KM) estimates.|Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)|ITT analysis set included all participants who were randomized to study treatment.|||months||95% Confidence Interval|Median
2582098|NCT02383966|Primary|Progression-free Survival (PFS) Time, as Assessed by an Independent Review Committee (IRC)|PFS time was defined as the time in months from the date of randomization until first observation of PD (based on imaging as assessed by IRC), or death due to any cause when death occurs within 60 days after the last tumor assessment or randomization (whichever is later). PD is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must also demonstrate an absolute increase of at least 5 millimeter. PFS was measured using Kaplan-Meier (KM) estimates.|Every 6 weeks starting from the date of randomization until occurrence of PD, assessed up to data-cutoff (904 days)|ITT analysis set included all participants who were randomized to study treatment.|||months||95% Confidence Interval|Median
2582099|NCT02383940|Secondary|Change From Baseline in Number of Hypoglycemic Events/Day (<=70 mg/dL) by Self-Monitored Blood Glucose (SMBG) at Week 12|Hypoglycemic event by SMBG was defined as an event in which the fingerstick measurement was <=70 mg/dL. The number of hypoglycemic events per day was calculated as a daily average number of episodes over the week prior to visit (Baseline and Week 12). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model.|Baseline, Week 12|Analysis was performed on mITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||events/day||Standard Error|Least Squares Mean
2582100|NCT02383940|Secondary|Change From Baseline in Glycemic Instability by Hyperglycemia (Continuous Glucose Monitoring [CGM] Area Under the Curve [AUC] >150 mg/dL) and Hypoglycemia (CGM AUC <70 mg/dL) Over a 24-hour Period at Week 12|Glycemic instability (mg/dL*minutes/1000) by hyperglycemia/hypoglycemia was measured by CGM AUC outside target range (as a daily average over the week prior to the visit [Baseline and Week 12]) over 24 hours, where outside target range was defined as CGM glucose AUC >150 mg/dL (hyperglycemia) and CGM glucose AUC <70 mg/dL (hypoglycemia). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model.|Baseline, Week 12|Analysis was performed on mITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||mg/dL*minutes/1000||Standard Error|Least Squares Mean
2582101|NCT02383940|Secondary|Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 12|"A 2-hour PPG sample (plasma) was obtained 2-hours after a standardized Mixed Meal at Baseline (Day 1) and at the visit at Week 12. At Week 12, study drug was to be given within 15 minutes before liquid Boost®, Ensure®, or similar nutrition drink product; at baseline, study drug was to be given after the 2-hour post-Mixed Meal PPG sample. Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from analysis of covariance (ANCOVA) model."|Baseline, Week 12|Analysis was performed on mITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2582102|NCT02383940|Secondary|Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12|The daily bolus and basal insulin doses were calculated as an average of the doses over 3 to 5 days before each visit (Baseline and Week 12). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model.|Baseline, Week 12|Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.|||International Units per day (IU/day)||Standard Error|Least Squares Mean
2582103|NCT02383940|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 12|Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Change was calculated by subtracting baseline value from Week 12 value. Least Square (LS) mean changes from baseline were obtained from mixed model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week-4 A1C (<=10%, >10%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.|Baseline, Week 12|Analysis was performed on mITT population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||percentage of A1C||Standard Error|Least Squares Mean
2582105|NCT02383862|Secondary|Percentage of Participants With Tests Ordered (Other Than Radiologic and Laboratory Tests) for SPADE Symptoms at Baseline Clinic Visit|Electronic medical records were reviewed to determine the number of tests ordered, other than radiologic or laboratory tests (e.g., sleep study), for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0 or 1≤ tests ordered for SPADE symptoms at baseline was calculated.|baseline|Participants whose electronic medical record of the baseline clinic visit was available for review|||percentage of participants|||Number
2582106|NCT02383862|Secondary|Percentage of Participants With Radiologic (RAD) Tests Ordered for SPADE Symptoms at Baseline Clinic Visit|Electronic medical records were reviewed to determine the number of radiologic (RAD) tests ordered for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0 or 1≤ RAD tests ordered for SPADE symptoms at baseline was calculated.|baseline|Participants whose electronic medical record of the baseline clinic visit was available for review|||percentage of participants|||Number
2582107|NCT02383862|Secondary|Percentage of Participants With Laboratory Tests Ordered for SPADE Symptoms at Baseline Clinic Visit|Electronic medical records were reviewed to determine the number of laboratory tests ordered for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0 or 1≤ lab tests ordered for SPADE symptoms at baseline was calculated.|baseline|Participants whose electronic medical record of the baseline clinic visit was available for review|||percentage of participants|||Number
2582108|NCT02383862|Secondary|Fatigue at 3-month Follow up, as Measured by the SF-36 Vitality Scale|For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, fatigue was assessed using the 4-item SF-36 (Short Form-36 Healthy Survey) vitality scale. The SF-36 vitality scale measures fatigue and energy over the past week. Possible scores range from 0 to 100, with lower scores reflecting greater fatigue.|3 month follow up|Participants who completed the SF-36 vitality scale at 3 month follow up|||units on a scale||Standard Deviation|Mean
2582109|NCT02383862|Secondary|Depression at 3-month Follow up, as Measured by the Patient Health Questionnaire (PHQ-2)|For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, depression was assessed using the 2-item Patient Health Questionnaire (PHQ-2). The PHQ-2 measures the frequency of depressive symptoms over the last 2 weeks. Possible scores range from 0 to 6, with higher scores reflecting more severe depression.|3 month follow up|Participants who completed the PHQ-2 at 3 month follow up|||units on a scale||Standard Deviation|Mean
2582110|NCT02383862|Secondary|Anxiety at 3 Month Follow up, as Measured by the Generalized Anxiety Disorder Scale (GAD-2)|For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, anxiety was assessed using the 2-item Generalized Anxiety Disorder scale (GAD-2). GAD-2 measures the frequency of anxiety symptoms over the past 2 weeks. Possible scores range from 0 to 6, with higher scores reflecting more severe anxiety.|3 month follow up|Participants who completed the GAD-2 at 3 month follow up|||units on a scale||Standard Deviation|Mean
2582111|NCT02383862|Secondary|Pain at 3 Month Follow up, as Measured by PEG|For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, pain was assessed using the 3-item PEG (Pain intensity, Enjoyment of life, and General activity). PEG measures pain intensity and interference in the past week. Possible scores range from 0 to 10, with higher scores reflecting more intense pain and interference.|3 month follow up|Participants who completed the PEG at 3 month follow up.|||units on a scale||Standard Deviation|Mean
2582112|NCT02383862|Secondary|Sleep at 3-month Follow up, as Measured by the Pittsburgh Insomnia Rating Scale (PIRS-2)|For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, sleep was assessed using the 2-item Pittsburgh Insomnia Rating Scale (PIRS-2). PIRS-2 measures quality and satisfaction with sleep over the past week. Possible scores range from 0 to 6, with higher scores reflecting poorer sleep.|3-month follow-up|Participants who completed the PIRS-2 at 3 month follow up|||units on a scale||Standard Deviation|Mean
2582113|NCT02383862|Secondary|Treatment Satisfaction at 3-Month Follow-up|At 3-month follow-up, treatment satisfaction was assessed. This 1-item measure assesses patients' satisfaction with the care of their symptoms overall on a 5-point Likert scale ranging from excellent to poor. Higher scores indicate poorer satisfaction.|3 month follow-up|Participants who responded to the treatment satisfaction question at 3 month follow up|||Participants|||Count of Participants
2582114|NCT02383862|Secondary|Change From Baseline in PROMIS Fatigue T-score at 3-Month Follow up|The 4-item PROMIS subscale for fatigue was administered to participants at baseline and at 3 month follow up. The fatigue subscale measures the extent to which patients experience problems with fatigue over the past 7 days using a 5-point Likert scale. Higher scores reflect greater fatigue. To assess the effects of feedback on fatigue, group differences in the change in PROMIS fatigue T-scores from baseline to 3-month follow up (baseline PROMIS fatigue T-score - 3 month PROMIS fatigue T-score) were calculated. Positive change scores are indicative of improvement in fatigue.|baseline and 3 month follow up|Multiple imputation was used to determine follow-up scores for nonrespondents.|||T-score||Standard Error|Mean
2582115|NCT02383862|Secondary|Change From Baseline in PROMIS Depression T-score at 3-Month Follow up|The 4-item PROMIS subscale for depression was administered to participants at baseline and at 3 month follow up. The depression subscale measures the extent to which patients experience depressive symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater depression. To assess the effects of feedback on depression, group differences in the change in PROMIS depression T-scores from baseline to 3-month follow up (baseline PROMIS depression T-score - 3 month PROMIS depression T-score) were calculated. Positive change scores are indicative of improvement in depression.|baseline and 3 month follow up|Multiple imputation was used to determine follow-up scores for nonrespondents.|||T-score||Standard Error|Mean
2582126|NCT02383706|Primary|Number of Participants With a Positive Obstructive Sleep Apnea (OSA) Home Sleep Test Result|Determined using the Apnea-Hypopnea Index (AHI). Participants were considered OSA-positive if experienced five or more events per hour.|Women studied at one time point between 24 weeks and 35 weeks gestation.||||Participants|||Count of Participants
2582116|NCT02383862|Secondary|Change From Baseline in PROMIS Anxiety T-score at 3-Month Follow up|The 4-item PROMIS subscale for anxiety was administered to participants at baseline and at 3 month follow up. The anxiety subscale measures the extent to which patients experience anxiety symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater anxiety. To assess the effects of feedback on anxiety, group differences in the change in PROMIS anxiety T-scores from baseline to 3-month follow up (baseline PROMIS anxiety T-score - 3 month PROMIS anxiety T-score) were calculated. Positive change scores are indicative of improvement in anxiety.|baseline and 3 month follow up|Multiple imputation was used to determine follow-up scores for nonrespondents.|||T-score||Standard Error|Mean
2582117|NCT02383862|Secondary|Change From Baseline in PROMIS Pain T-score at 3-Month Follow up|The 4-item PROMIS subscale for pain was administered to participants at baseline and at 3 month follow up. The pain subscale measures the extent to which patients experience problems with pain over the past 7 days using a 5-point Likert scale. Higher scores reflect greater pain. To assess the effects of feedback on pain, group differences in the change in PROMIS pain T-scores from baseline to 3-month follow up (baseline PROMIS pain T-score - 3 month PROMIS pain T-score) were calculated. Positive change scores are indicative of improvement in pain.|baseline and 3 month follow up|Multiple imputation was used to determine follow-up scores for nonrespondents.|||T-score||Standard Error|Mean
2582118|NCT02383862|Secondary|Change From Baseline in PROMIS Sleep T-score at 3-Month Follow up|The 4-item PROMIS subscale for sleep was administered to participants at baseline and at 3 month follow up. The sleep subscale measures the extent to which patients experience problems with sleep over the past 7 days using a 5-point Likert scale. Higher scores reflect more severe sleep problems. To assess the effects of feedback on sleep, group differences in the change in PROMIS sleep T-scores from baseline to 3 month follow up (baseline PROMIS sleep T-score - 3 month PROMIS sleep T-score) were calculated. Positive change scores are indicative of improvement in sleep.|baseline and 3 month follow up|Multiple imputation was used to determine follow-up scores for nonrespondents.|||T-score||Standard Error|Mean
2582119|NCT02383862|Primary|Change From Baseline in PROMIS Composite T-Score at 3-Month Follow-up|The 20-item PROMIS questionnaire (composed of 4-item scales for each of the 5 SPADE symptoms) was administered to participants at baseline and at 3 month follow up. PROMIS assesses the extent to which patients experience problems with SPADE symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater symptom severity. To assess the effects of feedback on SPADE symptom improvement, group differences in the change in PROMIS composite T-scores from baseline to 3 month follow up (baseline PROMIS T-score - 3 month PROMIS T-score) were calculated. Positive change scores are indicative of symptom improvement.|baseline and 3 month follow up|Multiple imputation was used to determine follow-up scores for nonrespondents.|||T-score||Standard Error|Mean
2582120|NCT02383758|Secondary|Mean Clinical Global Impression for Improvement (CGI-I) Score|An independent evaluator (IE) will use the parent target problem (PTP) interview to help caregivers estimate the frequency of encopresis as well as its impact on the family. From this description, the IE (who will be blind to treatment assignment) will generate a brief narrative describing the participant's encopresis. This narrative will be used by the IE to rate the overall severity on the 7-point Clinical Global Impression for Improvement (CGI-I). Clinical Global Impression for Improvement (CGI-I) Scale is a clinician's assessment of a patient's change in condition from baseline.The score ranges from 0 = not assessed, 1 = very much improved, through 7 = very much worse.|Post-Intervention (Week 6), Post-Intervention (Week 10)|An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.|||units on a scale||Standard Deviation|Mean
2582121|NCT02383758|Secondary|Mean Clinical Global Impression for Severity (CGI-S) Score|An independent evaluator (IE) will use the parent target problem (PTP) interview to help caregivers estimate the frequency of encopresis as well as its impact on the family. From this description, the IE (who will be blind to treatment assignment) will generate a brief narrative describing the participant's encopresis. This narrative will be used by the IE to rate the overall severity on the 7-point Clinical Global Impression for Severity (CGI-S). Clinical Global Impression of Severity (CGI-S) Scale is a clinician's assessment of patient's severity of illness. The score ranges from 1 = normal, not at all ill to 7 = among the most extremely ill patients|Baseline, Post-Intervention (Week 6), Post-Intervention (Week 10)|An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.|||units on a scale||Standard Deviation|Mean
2582122|NCT02383758|Secondary|Percent Independence|Percent independence is the percentage of independent bowel movements recorded by a caregiver. A continent bowel movement without the use of any medications will constitute an independent bowel movement.|Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)|An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.|||percentage of participants|||Number
2582123|NCT02383758|Primary|Percent Continent|The percentage of participant's with continent bowel movements (control of passage of stool from the bowel).|Baseline, Post-Intervention (Week 2) , Follow Up (Week 4)|An intention to treat (ITT) analysis was conducted; all participants who were enrolled and randomly allocated to treatment are included in the analysis.|||percentage of participants|||Number
2582124|NCT02383719|Primary|Clinician Assessment of Use With a Questionnaire|"With the questionnaire we desired to discern the clinicians perception of use of the experimental oro-nasal mask. The questionnaire featured the ease of installation, the ease of use, and the perceived comfort of the patient. Each of the scores were on a scale from 1-5 and each were recorded to be used for individual assessment. Thus each patient has multiple assessment scores individually reported as outcomes.~The clinicians were asked on a scale of 1-5 please rate their agreement with the statements The mask was easy to use. 1 strongly disagree, 2 somewhat disagree, 3 neutral, 4 somewhat agree, 5 strongly agree Your perception of patient comfort was acceptable. 1 strongly disagree, 2 somewhat disagree, 3 neutral, 4 somewhat agree, 5 strongly agree"|During non-invasive ventilation with the oro-nasal mask||||units on a scale||Inter-Quartile Range|Median
2582125|NCT02383706|Secondary|Post-op Minute Ventilation Following C-section|To evaluate post-operative minute ventilation in women who undergo cesarean delivery using a novel method of non-invasive minute ventilation monitoring|Women studied for 24-hours following their cesarean delivery.|Data not collected||||||
2582183|NCT02382744|Secondary|Immediate Complications|Any complications as a result of block placement (e.g. local anesthetic toxicity, hematoma, pain etc.)|60 minutes post block completion||||participants|||Number
2582127|NCT02383706|Primary|Number of Participants With a Negative Obstructive Sleep Apnea (OSA) Home Sleep Test Result|Determined using the Apnea-Hypopnea Index (AHI). Participants were considered OSA-negative if experienced less than five events per hour.|Women studied at one time point between 24 weeks and 35 weeks gestation.||||Participants|||Count of Participants
2582128|NCT02383667|Primary|Arrythmia|"quality of data obtained between harness and holter.~Subjective evaluation:~-Quality of the data will be rated on a 0 - 10 scale with 0 being unreadable and 10 being excellent"|15 minutes|there were 13 females and 7 males, mean age of 74.65|||Quality rating||Standard Deviation|Mean
2582129|NCT02383589|Secondary|Percentage of Participants With Immunoglobulin (Ig) Levels Below Lower Limit of Normal (LLN)||Baseline; Weeks 16, 24, 40 and 52; (end of treatment: up to Week 52) (up to CCOD of 28 November 2018)|The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug.|||Percentage of Participants|||Number
2582130|NCT02383589|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA)|Participants with treatment-induced and treatment-enhanced anti-drug antibodies. The clinical relevance of anti-rituximab antibody formation in RITUXAN treated pemphigus vulgaris (PV) participants is unclear.|Baseline up to 52 Weeks (up to CCOD of 28 November 2018)|The safety population (all participants who were randomized and received any part of an infusion of study drug), only participants for whom data were collected are included in the analysis.|||Percentage of Participants|||Number
2582131|NCT02383589|Secondary|Percentage of Participants With Adverse Events, Serious Adverse Events, and Corticosteroid-Related Adverse Events|An adverse event is any untoward medical occurrence in a participant to whom a medicinal product is administered and which does not necessarily have a causal relationship with this treatment. A serious adverse event is an adverse event that results in death or is life-threatening or requires/prolongs hospitalization or results in persistent/significant disability/incapacity or congenital abnormality/birth defect. Adverse events of Grade 3 of higher are severe and life-threatening adverse events CS-related adverse events - causality as determined by the investigator.|Baseline up to 52 Weeks (up to CCOD of 28 November 2018)|The safety population included all participants who were randomized and received any part of an infusion of study drug or oral administration of study drug.|||Percentage of Participants|||Number
2582132|NCT02383589|Secondary|Change in Health-Related Quality of Life (HRQoL), as Measured by the Dermatology Life Quality Index (DLQI) Score|Total DLQI scores range from 0 to 30 with higher DLQI scores reflecting greater impairment in a participant's health-related quality of life. The DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The measure type mean is the estimated mean from adjusted MMRM.|From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)|The modified intent-to-treat (mITT) population included participants in the ITT population, excluding the 10 telemedicine (TM) participants. This population was used in the analyses of efficacy outcomes. Only participants for whom data were collected are included in the analysis.|||Scores on a Scale||Standard Error|Mean
2582133|NCT02383589|Secondary|Time to Protocol Defined Disease Flare|Disease flare is defined as the appearance of three or more new lesions a month that do not heal spontaneously within 1 week or by the extension of established lesions in a participant who has achieved disease control.|From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)|The modified intent-to-treat (mITT) population included participants in the ITT population, excluding the 10 telemedicine (TM) participants. This population was used in the analyses of efficacy outcomes.|||Weeks||95% Confidence Interval|Median
2582134|NCT02383589|Secondary|Time to Initial Sustained Complete Remission||From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)|The modified intent-to-treat (mITT) population included participants in the ITT population, excluding the 10 telemedicine (TM) participants. This population was used in the analyses of efficacy outcomes.|||Weeks||95% Confidence Interval|Median
2582135|NCT02383589|Secondary|Total Number of Protocol Defined Disease Flares|Disease flare is defined as appearance of three or more new lesions a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a participant who has achieved disease control.|From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)|The modified intent-to-treat (mITT) population included participants in the ITT population, excluding the 10 telemedicine (TM) participants. This population was used in the analyses of efficacy outcomes.|||Number of Flares|||Number
2582136|NCT02383589|Secondary|Cumulative Oral Corticosteroid Dose||From Baseline up to 52 Weeks (up to CCOD of 28 November 2018)|The modified intent-to-treat (mITT) population included participants in the ITT population, excluding the 10 telemedicine (TM) participants. This population was used in the analyses of efficacy outcomes.|||milligram (mg)||Inter-Quartile Range|Median
2582137|NCT02383589|Primary|Percentage of Participants (Excluding Telemedicine [TM] Participants) Who Achieved Sustained Complete Remission, Evaluated by the Pemphigus Disease Area Index (PDAI) Activity Score||From Baseline up to 52 Weeks (up to clinical cut-off date (CCOD) of 28 November 2018)|The modified intent-to-treat (mITT) population included participants in the ITT population, excluding the 10 telemedicine (TM) participants. This population was used in the analyses of efficacy outcomes.|||Percentage of Participants|||Number
2582138|NCT02383576|Primary|Overall Survival|Overall survival was defined as the interval between start of the study and the date of death from any cause. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.|Up to 78 months|The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.|||months||95% Confidence Interval|Median
2582139|NCT02383576|Primary|Progression Free Survival (PFS)|PFS was defined as the time from start of the study to the first documented occurrence of disease progression. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.|Up to 78 months|The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.|||months||95% Confidence Interval|Median
2582184|NCT02382744|Secondary|Time Required to Administer Block|The time required for the block to be completed (from scanning to removal of needle)|10 minutes||||s||Standard Deviation|Mean
2582140|NCT02383576|Primary|Time From Last Maintenance Study Medication Start to Start of Further Anti-Cancer Therapy|Time from last maintenance study medication to the start of any further anti-cancer therapy was reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.|Up to 78 months|The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.|||days||Full Range|Median
2582141|NCT02383576|Primary|Percentage of Participants Who Received Further Anti-Cancer Therapies After Discontinuation of Study Treatment|Participants who received further anti-cancer therapies after discontinuation of study treatment were reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.|Up to 78 months|The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.|||percentage of participants|||Number
2582142|NCT02383576|Primary|Percentage of Participants Who Prematurely Withdrawn From Maintenance Therapy|Participants who had prematurely withdrawn from maintenance study treatment were reported. The retrospectively collected data was pooled with the data collected within the IMELDA (MO22223) P-trial to allow a statistically meaningful analysis.|Up to 78 months|The main analysis population was based on those participants of the maintenance phase Intent-to-Treat population (ITT) population (all randomized participants) of the IMELDA (MO22223) P-trial, who had consented to participate in this follow-up study.|||percentage of participants|||Number
2582143|NCT02383472|Secondary|Mean Difference in Change in Total Cognitive Symptom Score at Weeks 3 and Weeks 6|"This measure indicates the mean difference in total cognitive symptom scores between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 weeks scores. The total cognitive symptom scored is a sum of 7 symptom scores from the PCSS; feeling slowed down, feeling like in a fog, don't feel right, difficulty concentrating, difficulty remembering, fatigue or low energy, and confusion. The severity of these symptoms are scored 0-6, 0=none, 6=severe. The range for the total cognitive symptom score is 0-42, a lower score represents a better outcome."|From baseline to 3 weeks and from baseline to 6 weeks||||units on a scale||Standard Deviation|Mean
2582144|NCT02383472|Secondary|Mean Difference in Change in Total Post Concussion Symptom Score (PCSS) at Weeks 3 and Weeks 6.|This measure indicates the mean differences in total post concussion symptom score (PCSS) between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 week scores. The PCSS is a sum of severity scores from 0-6 (0=none, 6=severe) for 22 individual symptoms, like headache, neck pain, or drowsiness. The range for the PCSS is 0-132, a lower score represents a better outcome.|From baseline to 3 weeks and from baseline to 6 weeks||||units on a scale||Standard Deviation|Mean
2582145|NCT02383472|Secondary|Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Verbal Fluency Performance at Weeks 3 and 6.|This measure indicates the mean differences in Delis-Kaplan Executive Function System (D-KEF) tests between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 week scores. D-KEFs Verbal Fluency Test, made up of letter fluency and category fluency, is measured by number of responses, a larger number represents a better outcome. Participants were given 60 seconds to complete each fluency test.|From baseline to 3 weeks and from baseline to 6 weeks||||Correct responses||Standard Deviation|Mean
2582146|NCT02383472|Secondary|Mean Difference in Change in Delis-Kaplan Executive Function System (D-KEF) Color-Word Interference and Trail Making Test Performance at Weeks 3 and 6.|This measure indicates the mean differences in Delis-Kaplan Executive Function System (D-KEF) tests between entry into the study and 3 weeks and entry into the study and 6 weeks for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 3 week scores and the entry scores minus the 6 week scores. D-KEFs color-word interferences, made up of color naming, word reading, and inhibition, is measured in seconds, a smaller number represents a better outcome. Participants were given 90 seconds to complete color naming and word reading and 180 seconds to complete inhibition. D-KEFs trail making test, made up of number sequencing, letter sequencing, and number-letter sequencing, is measured in seconds, a faster speed (lower number) represents a better outcome. Participants were given 150 seconds to complete number and letter sequencing and 240 seconds to complete number-letter sequencing.|From baseline to 3 weeks and from baseline to 6 weeks||||Seconds||Standard Deviation|Mean
2582147|NCT02383472|Primary|Mean Difference in Change in Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) Score at Baseline and 6 Weeks.|The primary outcome is mean difference on composite scores of Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) between entry into the study and completion of treatment (visit 18, week 6) for both the LED group and the placebo group. The mean difference is calculated by taking the mean of differences of the entry scores minus the 6 week scores. There are 5 composite scores on the ImPACT test; verbal memory, visual memory, visual motor speed, reaction time, and symptom score. The ranges for these subscales are as follows: verbal memory and visual memory: 0-100, visual motor speed: 0-60, reaction time: 0-1.0, and symptom score: 0-132. A higher verbal memory, visual memory, and visual motor speed represent a better outcome, while a lower reaction time and lower symptom score represent a better outcome.|From baseline to 6 weeks||||Units on a scale||Standard Deviation|Mean
2582148|NCT02383433|Primary|Progression-free Survival|Time-to-event data will be summarized using the Kaplan-Meier method.|Up to 1 year from enrollment|Data was not collected for this outcome, study terminated early due to low accrual.||||||
2582185|NCT02382744|Secondary|Rate of Success of Elicitation of a Tapping Sensation at < 0.6 Milliampere (mA)|"Successful elicitation of tapping sensation in the saphenous nerve distribution at ≤ 0.6 mA"|5 minutes|"Participants in the Ultrasound Guidance and nerve stimulation group with successful stimulation and available current magnitude data"|||participants|||Number
2582149|NCT02383420|Secondary|Pair Preference Rating Scale|During the Reader Study the radiologists completed a paired preference rating using the following scale: -3, Image displayed on left is strongly preferred; -2, Image displayed on left is moderately preferred; -1, Image displayed on left is slightly preferred; 0, No preference between the images; 1, Image displayed on right is slightly preferred; 2, Image displayed on right is moderately preferred; 3, Image displayed on right is strongly preferred. Both the predicate and investigational images were randomly assigned to appear on the right or left monitors. A spreadsheet was used for managing the data. Prior to analysis, raw ratings were converted so that those in favor of the investigational device were made positive, and ratings in favor of the predicate device were made negative.|9 weeks after last x-ray capture|cadavers and live human subjects|||units on a scale|Participants|Standard Error|Mean
2582150|NCT02383420|Primary|Radlex Scale for Diagnostic Capability Ratings|1-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|9 weeks after last x-ray capture|A total of 177 image pairs were included for the reader study. Of the 177 pairs, 160 were cadaver image pairs. A total of seventeen (17) adult live human subject pairs were included in the reader study.|||units on a scale|Participants|Standard Error|Mean
2582151|NCT02383355|Secondary|Persistent Immune Activation - Monocyte Subsets|Monocyte subsets measured by flowcytometry. Classical monocytes (CD14+,CD16-), intermediate (CD14+CD16+), Non-classical (CD14dimCD16+). Reported values are change between baseline and week 10 and reported as ratio.|Baseline and week 10||||ratio||Full Range|Median
2582152|NCT02383355|Secondary|Circulating Levels of High Sensitive C-reactive Protein (Hs-CRP)|Plasma levels of hs-CRP (ng/mL) measured by ELISA . Change in concentration was calculated as a ratio between baseline (week 0) and week 10.|Baseline and week 10||||ratio||Standard Deviation|Mean
2582153|NCT02383355|Secondary|T-cell Dysfunction (CD4-cells)|Markers of persistent immune activation measured by flow cytometry (% of CD4-cells positive for CD38HLA-DR cells). Change after 10 weeks was calculated as a ratio between baseline and week 10.|Baseline and Week 10||||ratio||Full Range|Median
2582154|NCT02383355|Secondary|Platelet-leukocyte Aggregates (Platelet Monocyte Complex Measured by Flow-cytometry)|Platelet monocyte complex (PMCs) measured by flow-cytometry. % of CD61+ (platelet-marker) monocytes. Change after 10 weeks was calculated as a ratio between baseline and week 10.|Baseline and week 10||||ratio||Full Range|Median
2582155|NCT02383355|Primary|Platelet Reactivity Measured by Expression of P-selectin (CD62p) and Fibrinogen Binding|Platelet expression of the platelet activation marker CD62P (P-selectin) and of the activated fibrinogen receptor (αIIbβ3) through fibrinogen binding following stimulation with two concentrations of the platelet agonists ADP (adenosine diphosphate) and CRP-XL (crosslinked collagen related peptide). Difference between week 0 and week 10. Primary outcome is CD62p expression upon stimulation with ADP (power calculation based on this measure). Expression of both markers are expressed as MFI (Median fluorescence intensity) and measured by flowcytometry. Change after 10 weeks was calculated as a ratio between baseline and week 10.|Baseline and week 10|Intention to treat, if week 10 is not available, week 4 was used for these individuals (n=2)|||Ratio||Full Range|Median
2582156|NCT02383056|Secondary|Change in Total Surface Area of the Surgical Wound|A blinded investigator manually outlines the wound using a digital planimetry device to measure the surface area in square centimeters.|Week 1 to Week 2, Week 2 to Week 3, Week 3 to Week 4, Week 1 to Week 4||||Cm^2||Standard Deviation|Mean
2582157|NCT02383056|Secondary|Change in Relative Area of the Surgical Wound Remaining|Initial area * ((total area in the evaluated week/total area in the first week) * 100) and reported as a percentage (%)|Week 1 to Week 2, Week 2 to Week 3, Week 3 to Week 4||||Percentage of Wound Remaining||Standard Deviation|Mean
2582158|NCT02383056|Primary|Number of Days Required for the Wound to Heal Completely|Assessment by the physician indicating wound closure|84 days||||days||Standard Deviation|Mean
2582159|NCT02383043|Primary|The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative|The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Lile et al., 2016) in which subjects made 9 choices between each available cocaine dose and money (US$6.00). Reinforcing effects are measured for each cocaine dose during both d-amphetamine and placebo maintenance.|9 choice trials per cocaine dose level with each trial separated by 30 minutes||||cocaine choices||Standard Error|Mean
2582160|NCT02382991|Secondary|Number of Falls||Measurement will be performed at 1 month with both devices||||falls|||Number
2582161|NCT02382991|Secondary|SF-36v2™ Health Survey|36-Item Short Form Health Survey (SF-36v2TM) explores 8 dimensions of quality of life through 36 questions: PF= Physical Functioning (10 items), RP= Role Physical (4 items), BP = Bodily Pain (2 items), SF= Social Functioning (2 items), MH= Mental Health (5 items), RE= Role emotional (3 items), VT= Vitality (4 items), GH= General Health (5 items). All of the eight health domain scales contributes with different levels to score two component summary measures: PCS= Physical Component Summary and MCS= Mental Component Summary. All scores are calculated online through scoring software. Domain scales and component summary are ranging from 0 to 100. A high score is considered to be a better outcome, as indicating little or no problem.|Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK||||scores on a scale||Standard Deviation|Mean
2582186|NCT02382744|Secondary|Mean Minimum Stimulation Current|"the mean minimum stimulation current magnitude to elicit tapping sensation in the saphenous nerve distribution (cf. 3.2.3 below)"|5 minutes|"Participants in the Ultrasound Guidance and nerve stimulation group with available data"|||mA||95% Confidence Interval|Mean
2582187|NCT02382744|Secondary|Rate of Success of Elicitation of a Tapping Sensation|"successful elicitation of any tapping sensation in the saphenous nerve distribution within the 5 min stimulation time limit"|5 minutes||||participants|||Number
2582627|NCT02377362|Primary|Number of Participants With One or More Treatment Emergent Adverse Events (Parts B)|Treatment Emergent Adverse Event defined as an adverse event that started or worsened in severity at the time of, or after treatment|Baseline to 6 weeks||||Participants|||Count of Participants
2582162|NCT02382991|Secondary|QUEST 2.0 Satisfaction Questionnaire (QUEST 2.0-G: German Version / ESAT: French Version)|It is a self-evaluation questionnaire of the user's satisfaction, translated in French (ESAT) and in German (QUEST 2.0-G Section 17.5). The QUEST 2.0 questionnaire contains 8 items that evaluate the device's technology and 4 items that evaluate services surrounding the device. It allows patients to express themselves on the criteria that are most important to them. Each item has a score that varies between 0 (not satisfied at all) and 5 (very satisfied). The global score is the average obtained onto the 12 items. Two sub-scores related to the technology and services can also be calculated. They correspond to the average of the 8 first items and to the 4 last items respectively. All scores ranks between 0 and 5, 5 being the highest level of satisfaction.|Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK||||Score from 0 to 5||Standard Deviation|Mean
2582163|NCT02382991|Secondary|Use of Walking Aids|The type of walking aids used with each device will be recorded.|Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK|No significant difference in the repartition of walking aids was – a priori- expected between both devices: NMPK and 3C60.|||participants|||Number
2582164|NCT02382991|Secondary|Locomotor Capabilities Index (LCI-5)|The Locomotor Capabilities Index (LCI-5) is a 14 item self-assessment questionnaire filled in by the patient that explores walking and ambulation. The LCI-5 is derived from the Prosthesis Profile of the Amputee Questionnaire (PPA). LCI-5 is sensitive to the use of walking aids or to the need of a third party. Ceiling effect is not expected with moderately active amputees. The global LCI-5 score is the addition of the 14 scores, noted between 0 and 4. The global score varies between 0 and 56, the highest being for persons with high locomotors capabilities. LCI-5 has two sub-scores: the basic score corresponds to 7 questions related to basic activities and the advanced score corresponds to 7 questions related to more advanced activities. The basic and advanced scores both range from 0-28. Higher scores correspond with a better outcome.|Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK||||Score between 0 and 56||Standard Deviation|Mean
2582165|NCT02382991|Primary|Timed Get Up and Go (TGUG)|This test consists of recording the amount of time needed for a person to stand up from a chair, walk 3 metres, make a half-turn and sit down again. The TGUG test score reflects a person's balance and as a consequence, the risk of falling.|Measurement will be performed at 3 months with 3C60 and at 1 month with NMPK||||seconds||Standard Deviation|Mean
2582166|NCT02382913|Primary|Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.|"Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1.~Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1|Analysis were done on per protocol set. Note: Number of participants analyzed for Day 1 of V113_01E1/ Day 180 of V113_01 FHA and PRN was 33, 28, 28, 32 respectively.|||Ratios||95% Confidence Interval|Geometric Mean
2582167|NCT02382913|Primary|Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.|"Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1.~Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1|Analysis were done on per protocol set|||Ratios||95% Confidence Interval|Geometric Mean
2582168|NCT02382913|Primary|Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.|"Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1.~Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1|Analysis were done on per protocol set. Note: Number of participants analyzed for Day 1 of V113_01E1/ Day 180 of V113_01 PT, FHA and PRN was 27, 32, 31, 32 respectively.|||Ratios||95% Confidence Interval|Geometric Mean
2582169|NCT02382913|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1.|"The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D4aP1, T5D4aP2 and T5D4aP4 Groups versus the response to the commercially available Tdap comparator.~Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1|Analysis were done on per protocol set.|||IU/mL||95% Confidence Interval|Geometric Mean
2582170|NCT02382913|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1.|"The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D2aP1, T5D2aP2 and T5D2aP4 Groups versus the response to the commercially available Tdap comparator.~Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1|Analysis were done on per protocol set.|||IU/mL||95% Confidence Interval|Geometric Mean
2582209|NCT02382016|Secondary|Change From Baseline to Week 12 in Cardiac Index|The cardiac index is an assessment of the function of the heart and relates the cardiac output to the patient's body size (the patient's body surface area).|From enrollment/baseline to Week 12 in the DB treatment period||||L/min/m^2||Standard Deviation|Mean
2582628|NCT02377362|Primary|Number of Participants With One or More Treatment Emergent Adverse Events (Part A)|Treatment Emergent Adverse Event defined as an adverse event that started or worsened in severity at the time of, or after treatment|Baseline to 7 weeks||||Participants|||Count of Participants
2582171|NCT02382913|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1.|"The antibody response against the pertussis antigen components (PT, FHA and PRN) at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in aP1, aP2, aP4 Groups versus the response to the commercially available Tdap comparator.~Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups."|Day 1|"Analysis were done on per protocol set (PPS) i.e., All subjects in the all enrolled set who provided immunogenicity data at V113_01E1 visit 1 and:~correctly received the vaccine in the V113_01 parent study~had no major protocol deviations leading to exclusion or were not excluded due to other reasons as defined prior to analysis"|||IU/mL||95% Confidence Interval|Geometric Mean
2582172|NCT02382848|Secondary|Decrease in Self Harm Thoughts as Measured by the HDRS and Subject Interview|Rating scales and subject interview will be used to determine if there is a decrease in self harm among participants undergoing drug intervention. The HDRS (Hamilton Depression Rating Scale) consists of 17 items, some scored on a 5-point scale (0-4) and others scored on a 3-point scale (0-2). Items from the scale can be summed to give a total score ranging from 0 to 50, with higher scores indicating a worse outcome. This analysis is based on a single item from the scale (Self Harm, measured on a 5-point scale) where a higher score again indicates a worse outcome.|3 weeks||||score on a scale||Standard Error|Mean
2582173|NCT02382848|Secondary|Decrease in Depressed Mood as Measured by the HDRS (Hamilton Depression Rating Scale) and Subject Interview|Rating scales and subject interview will be used to determine if there is a decrease in depressed mood among participants undergoing drug intervention. The HDRS (Hamilton Depression Rating Scale) consists of 17 items, some scored on a 5-point scale (0-4) and others scored on a 3-point scale (0-2). Items from the scale can be summed to give a total score ranging from 0 to 50, with higher scores indicating a worse outcome. This analysis is based on a single item from the scale (Depressed Mood, measured on a 5-point scale) where a higher score again indicates a worse outcome.|3 weeks||||score on a scale||Standard Error|Mean
2582174|NCT02382848|Secondary|Decrease in Total CAPS Score (PTSD)|The CAPS (Clinician administered PTSD) rating scale consists of 30 questions rated on a 0-4 point scoring system and patient interview will be used to determine if there is a decrease in PTSD Symptoms among participants undergoing drug intervention. 17 of these questions are used to calculate the total severity score used in this analysis. This is done by summing the frequency and intensity ratings (each ranging from 0-4) for each of the 17 questions. The total severity score can have a range of 0-136. A higher score on this scale indicates a worse outcome.|3 weeks||||score on a scale||Standard Error|Mean
2582175|NCT02382848|Secondary|Decrease in Bulimia Symptoms|EDI-3 (Eating Disorder Inventory 3 Scale) is a pencil and paper test consisting of 91 items and 12 sub-scales. The main scales are the drive for thinness and the bulimia scales, the remaining sub-scales are: low self-esteem, body dissatisfaction, maturity fears, personal alienation, interpersonal alienation, interpersonal insecurity, perfectionism, interoceptive deficits, emotional dysregulation, and asceticism. The response options are based on a 6-point Likert-type scale are: Always, Usually, Often, Sometimes, Rarely, and Never. There are six composite scores, 12 primary scores, and three response style validity indicators. Software is used to calculate the raw scores, composite scores, validity scale scores and the T-scores. The t-score for the Bulimia scale will be used for this analysis with a range of 22-66. Higher scores indicate the likelihood of an eating disorder. A higher t-score on the bulimia scale indicates a worse outcome.|3 weeks||||T-Score||Standard Error|Mean
2582176|NCT02382848|Primary|Decrease in Rapid Eye Movement (REM) Density & Normalization of REM Disruptions|PSG (Polysomnogram) will be used in 2 participants to determine if there is a decrease in REM density in patients undergoing drug intervention.|3 weeks|This study was designed to include a second phase involving polysomnography in 2 participants if there was enough signal efficacy found based on subjective measures. The second phase was not done, therefore no data was analyzed for this outcome measure.||||||
2582177|NCT02382848|Primary|Decrease in Frequency of Nightmares Using the Sleep-50 Questionnaire|"The individual question about frightening dreams from the Nightmares Subscale of a self-administered questionnaire (Sleep-50 Questionnaire), will be used to determine if there is a decrease in frequency of nightmares in patients undergoing drug intervention. For each question, respondents are provided with a scale ranging from 1 (not at all) to 4 (very much) and are asked to indicate the extent to which the statement has matched their experience over the study time frame. The scale values range from 1-4, where a lower value indicates lower frequency of nightmares. A higher score is a worse outcome."|3 weeks||||score on a scale||Standard Error|Mean
2582178|NCT02382744|Post-Hoc|Response Versus Lack of Response to Nerve Stimulation and Block Failure Rate|Percentage of block failure (persistent sensation in the saphenous nerve distribution at 30 minutes -- i.e., absence of any evidence of blockade [decreased or complete absence of sensation] at both areas: normal sensation) among participants in the Ultrasound Guidance and Nerve Stimulation group with response versus no response to nerve stimulation|30 min||||participants|||Number
2582179|NCT02382744|Post-Hoc|Sensory Blockade Scores by Individual Assessment Area: Medial Tibial Condyle|Sensation to pinprick with an 18 gauge blunt needle was assessed individually at the two different anatomic areas in the distribution of the saphenous nerve: Here, the results are reported for the area 10 cm distal to the medial tibial condyle only|30 min||||participants|||Number
2582180|NCT02382744|Post-Hoc|Sensory Blockade Scores by Individual Assessment Area: Medial Malleolus|Sensation to pinprick with an 18 gauge blunt needle was assessed individually at the two different anatomic areas in the distribution of the saphenous nerve: Here, the results are reported for the area 2 cm proximal to the medial malleolus only|30 min||||participants|||Number
2582181|NCT02382744|Post-Hoc|Speed of Onset for Any Blockade in the Area 2 cm Proximal to the Medial Malleolus Only|"Median (Kaplan-Meier curve survival) time required to reach any evidence of sensory blockade (decreased or complete absence of sensation) in the area 2 cm proximal to the medial malleolus only"|30 min|Participants with any evidence of sensory blockade (decreased or complete absence of sensation) in the area 2 cm proximal to the medial malleolus only|||Minutes||95% Confidence Interval|Median
2582182|NCT02382744|Secondary|Delayed Complications|Any complication as a results of nerve block placement (e.g. persistent paresthesia, nerve injury)|7 days post operative||||participants|||Number
2582188|NCT02382744|Secondary|Speed of Onset for Nerve Block (Complete Blockade)|"Median (Kaplan-Meier curve survival) time required to reach complete absence of sensation to pinprick at the two different anatomic areas of assessment in the distribution of the saphenous nerve (2 cm proximal to the medial malleolus and 10 cm distal to the medial condyle of the tibia)."|30 minutes post nerve block|Participants with complete absence of sensation to pinprick at the two different anatomic areas of assessment in the distribution of the saphenous nerve (2 cm proximal to the medial malleolus and 10 cm distal to the medial condyle of the tibia)|||Minutes||95% Confidence Interval|Median
2582189|NCT02382744|Secondary|Incomplete Block Rate|incomplete [decreased only] loss of sensation in the saphenous nerve distribution at 30 minutes at both areas of assessment|30 minutes post nerve block||||participants|||Number
2582190|NCT02382744|Secondary|Any Evidence of Blockade (Decreased or Complete Absence of Sensation)|Participants with any evidence of blockade (decreased or complete absence of sensation) at the two different anatomic areas in the distribution of the saphenous nerve (2 cm proximal to the medial malleolus and 10 cm distal to the medial tibial condyle)|30 min||||participants|||Number
2582191|NCT02382744|Secondary|Block Failure Rate|Persistent sensation in the saphenous nerve distribution at 30 minutes (i.e., absence of any evidence of blockade [decreased or complete absence of sensation] at both areas: normal sensation.|30 minutes post nerve block||||participants|||Number
2582192|NCT02382744|Primary|Block Success|Complete absence of sensation to pinprick at two different anatomic areas of the saphenous nerve at thirty minutes|30 minutes post nerve block||||participants|||Number
2582193|NCT02382705|Secondary|Small Bowel Transit Time|times it takes for capsule camera to traverse the entire small bowel.|0.1 - 12 hours||||minutes||Standard Deviation|Mean
2582194|NCT02382705|Secondary|Gastric Transit Time|time it takes for capsule camera to traverse the stomach|0.1 - 12 hours||||minutes||Standard Deviation|Mean
2582195|NCT02382705|Secondary|Diagnostic Yield|rate at which a pathological finding is identified on capsule endoscopy|0.1 - 12 hours||||Participants|||Count of Participants
2582196|NCT02382705|Primary|Completion Rate (Rate at Which Small Bowel is Completely Examined)|rate at which small bowel is completely examined (capsule endoscopy enters cecum)|0.1 - 12 hours||||Participants|||Count of Participants
2582197|NCT02382640|Primary|Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG)||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.|||participants|||Number
2582198|NCT02382640|Primary|Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Evaluation||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.|||participants|||Number
2582199|NCT02382640|Primary|Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.|||participants|||Number
2582200|NCT02382640|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.|||participants|||Number
2582201|NCT02382640|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)||Day 1 up to 30 days after last dose of drug (Day 31 for each of the 4 periods)|The safety set was defined as all participants who were enrolled and received at least 1 dose of study drug.|||participants|||Number
2582202|NCT02382640|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Febuxostat||Days 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2582203|NCT02382640|Primary|AUC(0-tau): Area Under the Plasma Concentration-time Curve During the Dosing Interval for Febuxostat||Days 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
2582204|NCT02382640|Primary|Cmax: Maximum Observed Plasma Concentration for Febuxostat||Days 1 at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic set consisted of all participants who received study drug and had at least 1 measurable plasma concentration.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2582205|NCT02382133|Secondary|Device Related Pressure Ulcer|"assessment for development of pressure ulcer at forehead sensor, OxiMaxTM, Nellcor,Covidien and nasal alar sensor, Alar One-SenseTM, Xhale Assurance"|5 days|incidence of any pressure injury|||participants|||Number
2582206|NCT02382133|Primary|Accuracy as Indicated by Co-oximetry Measure of Arterial Oxygen Saturation|accuracy of sensor measure was defined as sensor measurements within 3% of co-oximetry measures|24 hours|Nasal sensor unable to obtain a signal 7% of measures on enrollment, Forehead sensor unable to obtain signal 32% of measures on enrollment.|||Participants|||Count of Participants
2582207|NCT02382016|Secondary|Change From Baseline to Week 12 in Mixed Venous Oxygen Saturation (SVO2)|SVO2 help assess tissue oxygen delivery. It describes the percentage of oxygen bound to hemoglobin in the blood which returns to the heart. This reflects the amount of residual oxygen in the blood after oxygen extraction by the tissues throughout the body.|From enrollment/baseline to Week 12 in the DB treatment period|Full Analysis Set(FAS): All randomized participants who received at least one dose of study drug in DB treatment, have baseline value for PVR, evaluated As per assigned treatment. Here, ‘N’(number of participants analyzed included population included participants with available baseline data.|||percent of oxygen bound to hemoglobin||Standard Deviation|Mean
2582208|NCT02382016|Secondary|Change From Baseline to Week 12 in Total Pulmonary Resistance (TPR)|TPR is the resistance the pulmonary circulation that must be overcome in order for the blood flow to occur. It takes into account the blood pressure in the pulmonary arteries and the cardiac output. It is an important measurement to monitor the function of the pulmonary circulation and detect disease progression or improvement.|From enrollment/baseline to Week 12 in the DB treatment period||||dyn*sec/cm^5||Standard Deviation|Mean
2582210|NCT02382016|Secondary|Change From Baseline to Week 12 in Mean Pulmonary Artery Pressure (mPAP)|mPAP is the mean blood pressure inside the pulmonary artery which moves the blood from the heart to the lungs. Monitoring of mPAP can detect small changes in the function of the heart.|From enrollment/baseline to Week 12 in the DB treatment period||||mmHg||Standard Deviation|Mean
2582211|NCT02382016|Secondary|Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)|mRAP is the mean blood pressure in the right atrium of the heart.|From enrollment/baseline to Week 12 in the DB treatment period|Full Analysis Set(FAS): All randomized participants who received at least one dose of study drug in DB treatment, have baseline value for PVR, evaluated As per assigned treatment. Here, ‘N’(number of participants analyzed included population included participants with available baseline data.|||mmHg||Standard Deviation|Mean
2582212|NCT02382016|Secondary|Change From Baseline to Week 12 in the Biomarker N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)|NT-proBNP functions as a strong indicator of prognosis in patients with pulmonary hypertension (PH). The relative change from baseline to Week 12 in NT-proBNP is expressed as a ratio of Week 12 to baseline NT-proBNP.|From enrollment/baseline to Week 12 in the DB treatment period|Full Analysis Set(FAS): All randomized participants who received at least one dose of study drug in DB treatment, have baseline value for PVR, evaluated As per assigned treatment. Here, ‘N’(number of participants analyzed included population included participants with available baseline data.|||ratio||95% Confidence Interval|Geometric Mean
2582213|NCT02382016|Secondary|Change From Baseline to Week 12 in WHO Functional Class (FC)|Changes from baseline to Week 12 in WHO FC were dichotomized as worsening (i.e., change > 0) versus no change or improvement (i.e., change ≤ 0). Class I: no symptoms with exercise or at rest. No limitation of activity. Class II: No symptoms at rest but slight limitation with ordinary activities causing symptoms (e.g. short of breath with climbing a flight of stairs, grocery shopping, or making the bed). Class III: may not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting. Class IV: symptoms at rest (e.g. dyspnea and/or fatigue) and inability to carry out any physical activity without symptoms. Patients in class IV manifest signs of right heart failure.|From enrollment/baseline to Week 12 in the DB treatment period||||Participants|||Count of Participants
2582214|NCT02382016|Secondary|Change From Baseline to Week 12 in 6-minute Walk Distance (6MWD)|The purpose of the six minute walk is to test exercise tolerance and capacity. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.|From enrollment/baseline to Week 12 in the DB treatment period||||meter||Standard Deviation|Mean
2582215|NCT02382016|Primary|Relative Change From Baseline to Week 12 in Pulmonary Vascular Resistance (PVR).|The relative change from baseline to Week 12 in PVR is expressed as a ratio of Week 12 to baseline PVR.|From enrollment/baseline to Week 12 in the Double Blind (DB) treatment period||||ratio||95% Confidence Interval|Geometric Mean
2582216|NCT02381795|Primary|Headache Pain Intensity|Greatest change in headache pain intensity post treatment (at any time point within 30 minutes of Nasal CO2 administration) - pre-treatment. Pain intensity will be measured as follows: 0 = no pain, 1 = mild pain, 2 = moderate pain, and 3 = severe pain. Full Range values were calculated change values, and do not represent the full range of the scale.|Immediately preceeding treatment to 30 minutes post-treatment|Enrolled subjects reporting at least one headache during study period. One enrolled subject did not experience any headaches during the study period and thus was not included in the analysis.|||units on a scale|Cluster Headaches|Full Range|Mean
2582217|NCT02381678|Primary|The Performance Evaluation of Perimount Heart Valve(Type:6900P and 2900) by Echocardiography|This is a one-arm study. All enrolled 225 subjects are required to be back Gungdong General Hospital to do an Echocardiography|7-15 years after heart valve replacement surgery (during 2001-2007)||||Percentage of all subjects|||Number
2582218|NCT02381418|Secondary|Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.||up to 3 weeks post vaccination||||participants|||Number
2582219|NCT02381418|Primary|the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.|Mean fold increase in HI antibody titer 3 weeks After Vaccination in non-elderly adults and elderly adults.|3 weeks post vaccination|Two subjects were excluded from the efficacy sample due to major protocol violations with a potential effect on immunogenicity outcome.|||fold change||95% Confidence Interval|Mean
2582220|NCT02381418|Primary|the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines.|Seroprotection and Seroconversion Rate for A/H1N1, A/H3N2, and B Strains 3 weeks After Vaccination in non-elderly adults and elderly adults.|3 weeks post vaccination|Two subjects were excluded from the efficacy sample due to major protocol violations with a potential effect on immunogenicity outcome.|||percentage of subjects||95% Confidence Interval|Number
2582221|NCT02381392|Secondary|Success in Patients With High Difficult Intravenous Access Scores|Successful: Intravenous line successfully placed with blood able to be drawn back and fluid able to be flushed into the vein. Flashback but IV blown: blood initially successfully drawn back or seen in the syringe, but subsequently unable to flush fluid into the vein. No flashback: no blood drawn back into or seen in the syringe at all. Missing data: data not recorded regarding success or flashback.|Intravenous access attempts during the current emergency department visit only, average of 60 minutes||||Participants|||Count of Participants
2582222|NCT02381392|Secondary|Nursing Satisfaction (Likert Scale)|To compare nursing satisfaction using a Likert scale between use of the AV400 and the standard technique.|Intravenous access attempts during the current emergency department visit only, average of 60 minutes||||Participants|||Count of Participants
2582223|NCT02381392|Secondary|Parent Satisfaction (Likert Scale)|To compare parent satisfaction using a Likert scale between use of the AV400 and the standard technique|Intravenous access attempts during the current emergency department visit only, average of 60 minutes||||Participants|||Count of Participants
2582224|NCT02381392|Secondary|Median Number of Intravenous Attempts|To compare the median number of IV access attempts until success or escalation of therapy to the difficult IV access team between those placed with the AV400 as to those without (ie the standard technique).|Intravenous access attempts during the current emergency department visit only, average of 60 minutes||||Participants|||Count of Participants
2582225|NCT02381392|Primary|First Attempt Success at Intravenous Access|Successful: Intravenous line successfully placed with blood able to be drawn back and fluid able to be flushed into the vein. Flashback but IV blown: blood initially successfully drawn back or seen in the syringe, but subsequently unable to flush fluid into the vein. No flashback: no blood drawn back into or seen in the syringe at all. Missing data: data not recorded regarding success or flashback.|Intravenous access attempts during the current emergency department visit only, average of 60 minutes||||Participants|||Count of Participants
2582226|NCT02381288|Secondary|Terminal Elimination Half-life (T1/2) for TAK-448F|T1/2 is the time required for half of the drug to be eliminated from the plasma.|Once-daily Dosing Days 1 and 42, Twice-weekly Dosing Days 1 and 39, Once-weekly Dosing Days 1 and 36, predose and at multiple time intervals (up to 8 hours) post-dose.|Due to early termination of the study pharmacokinetic data was not collected and reported.||||||
2582227|NCT02381288|Secondary|AUCt: Area Under the Plasma Concentration-Time Curve for TAK-448F|Area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.|Once-daily Dosing Days 1 and 42, Twice-weekly Dosing Days 1 and 39, Once-weekly Dosing Days 1 and 36, predose and at multiple time intervals (up to 8 hours) post-dose.|Due to early termination of the study pharmacokinetic data was not collected and reported.||||||
2582228|NCT02381288|Secondary|Cmax: Maximum Observed Plasma Concentration for the Free Form of TAK-448 (TAK-448F)|Cmax is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Once-daily Dosing Days 1 and 42, Twice-weekly Dosing Days 1 and 39, Once-weekly Dosing Days 1 and 36, predose and at multiple time intervals (up to 8 hours) post-dose.|Due to early termination of the study pharmacokinetic data was not collected and reported.||||||
2582229|NCT02381288|Secondary|Serum Testosterone Cmax: Maximum Observed Plasma Concentration|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Assessments were done Day 1 and Day 42 for once daily regimen, on Day 36 for once weekly regimen and on Day 39 for twice-weekly regimen (Day 42/36/39).|Day 1 (first dose) and Day 42 for once-daily regimen, Day 39 for twice-weekly regimen, or Day 36 for once-weekly regimen (last dose)|PD analysis set included all participants who received at least 1 dose of study drug or placebo and who have at least 1 valid PD measure.|||ng/dL||Standard Deviation|Mean
2582230|NCT02381288|Primary|Trough Serum Concentration (Ctrough) of ST|Trough serum concentration of total and free ST, defined as lowest Baseline concentration.|Once-daily regimen Day 42; Twice-weekly regimen Day 39; Once-weekly regimen Day 36|PD analysis set included all participants who received at least 1 dose of study drug or placebo and who had at least 1 valid PD measure. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||ng/dL||Standard Deviation|Mean
2582231|NCT02381288|Primary|Percent Change From Baseline in Average Serum Concentration (Cav) of Total ST After 6 Weeks of Dosing|Cav is the average serum concentration of the dosing interval, calculated as area under the effect curve (AUEC) divided by the duration of the dosing interval.|Once-daily regimen Day 42; Twice-weekly regimen Day 39; Once-weekly regimen Day 36|Pharmacodynamic (PD) analysis set included all participants who received at least 1 dose of study drug or placebo and who had at least 1 valid PD measure.|||percent change||Standard Deviation|Mean
2582232|NCT02381015|Secondary|Accuracy of Recall of Risk Information at 3 Months Measured by Survey|"Mean between recall of risk information at 3 months measured by survey, and told risk information. Recall at 3 months is measured by survey question: Based on the information given to you, what were you told is your chance of developing prostate cancer in your lifetime from 0% to 100% ______ %"|3 month||||Percentage of recall||Standard Deviation|Mean
2582233|NCT02381015|Secondary|Accuracy of Immediate Recall of Risk Information Measured by Survey|"Mean between Immediate recall of risk information and told risk information. Immediate recall is measured by survey question: Based on the information given to you, what were you told is your chance of developing prostate cancer in your lifetime from 0% to 100% ______ %"|Baseline||||Percentage of recall||Standard Deviation|Mean
2582234|NCT02381015|Secondary|Anxiety, Measured by State-trait Anxiety Inventory (STAI)|"Immediate reaction to risk information. Measured by state anxiety scale that assess current feelings at this moment: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. A shortened version of questions 1,3,5,9,11,12,13,15,17, and 19 from STAI form XI were used. Each item, within then STAI is scored on a scale of 1-4 and with 10 items, the possible range of total scores was 10 (lowest anxiety) to 40 (highest anxiety). Lowest scores represent better outcomes."|Baseline|Computerized randomization of 700 study identifiers into 175 blocks of four each was completed prior to enrollment. Genetic Risk Score=GRS and Family History=FH. Randomization groups were (Group 1) GRS+FH as a number; (Group 2) GRS+FH as a number and pictograph; (Group 3) FH as a number; and (Group 4) FH as a number and pictograph.|||units on a scale||Standard Deviation|Mean
2582235|NCT02381015|Primary|Number of Participants Who Had PSA Testing at 3 Years, Measured by Medical Records|PSA screening, measured by medical records 3 years after provision of risk information.|3 years||||participants|||Number
2582236|NCT02381015|Primary|Number of Participants Who Had PSA Testing at 3 Months, Measured by Survey|PSA screening, measured by survey 3 months after provision of risk information.|3 months||||participants|||Number
2582237|NCT02381015|Primary|Number of Participants Who Had Prostate Specific Antigen (PSA) Discussion With Physician at 3 Months, Measured by Survey|Discussion with Physician regarding PSA screening, measured by survey 3 months after provision of risk information|3 months||||participants|||Number
2582238|NCT02380859|Primary|Change in Postural Control - Composite Latency Score on the Berg Balance Scale|"Berg Balance Scale. This 14-item test assesses balance during different tasks. Items consist of specific items such as standing with eyes closed, retrieving an object from the floor, and turning to look behind. The assessor rates the patient's performance from 0 (lowest level of function) to 4 (highest level of function) and a total is calculated out of a maximum score of 56."|Baseline (Day 0) and Day 15||||scores on a scale||Standard Deviation|Mean
2582306|NCT02379728|Other Pre-specified|Medical Staff Questionnaire - Session Cultural Issues|Were any cultural issues encountered during the Introduction and Instruction for PrenaBelt sessions (yes/no; if yes, describe).|From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)|All four maternity personnel conducting the device introduction sessions completed this question on the maternity personnel questionnaire.|||Participants|||Count of Participants
2582239|NCT02380859|Primary|Change in Postural Control - Composite Latency Score on the Motor Control Test|The MCT assesses the ability of the automatic motor system to quickly recover following an unexpected external disturbance. Sequences of small, medium or large platform translations (scaled to the patient's height) in forward and backward directions elicit automatic postural responses. Translation of the surface in one horizontal direction results in displacement of the COG away from center in the opposite direction relative to the base of support. To restore normal balance, a quick movement of the COG back to the center position is required. A composite latency value is provided as the time in milliseconds between the force plate translation and the patient's active corrective responses, averaged across all translation sizes and directions.|Baseline (Day 0) and Day 15||||ms||Standard Deviation|Mean
2582240|NCT02380859|Primary|Change in Postural Control - Forward-backward Displacement of Centre of Gravity on the Sensory Organisation Test SMART EquiTest Balance Master|The participant is asked to maintain an upright posture under different conditions of sensory feedback. Proprioceptive feedback to the feet and joints is manipulated by allowing the platform to tilt to directly follow the participant's anteroposterior body sway (constant proprioception) or by maintaining the standing platform in a fixed horizontal position (normal proprioceptive feedback). Visual feedback is provided by asking the participant to close their eyes (no visual feedback), asking the participant to open their eyes and allowing the visual surround to tilt directly following the participant's anterioposterior body sway (constant visual feedback), or by asking the participant to keep their eyes open and maintaining the visual surround in a fixed position (normal visual feedback). Forward-backward displacement of COG is recorded in degrees.|Baseline (Day 0) and Day 15||||Degrees||Standard Deviation|Mean
2582241|NCT02380859|Other Pre-specified|Change in Activities of Daily Living - Parkinson's Disease Questionnaire|"Parkinson's Disease Questionnaire (PDQ-39), mobility and activities of daily living sections. This 39-item questionnaire is the most widely-used Parkinson's Disease specific measure of health and daily function. Participants indicate the extent to which they have experienced problems with different aspects of mobility and self-care. Each item is scored from 0 (never have problems) to 4 (always have problems), and a percentage is calculated. In addition to the total score, the mobility (questions 1-10) and activities of daily living (questions 11-16) sub-sections can be analysed separately to assess changes in these specific outcomes. The responses are summed and scored as a percentage. We analysed the percentage scores for the mobility sub-section, the activities of daily living sub-section, and the total percentage. Higher values indicate worse outcome."|Baseline (Day 0) and Day 15||||percentage||Standard Deviation|Mean
2582242|NCT02380859|Other Pre-specified|Change in Activities of Daily Living - Activity-specific Balance Confidence Scale|"Activities-specific Balance Confidence Scale. This 16-item questionnaire is similar to the Falls Efficiency Scale, but has greater sensitivity to gait impairments in more ambulatory patients. Responses are given on a scale from 0 (very confident) to 10 not very confident) and a total score out of 100 is computed."|Baseline (Day 0) and Day 15||||scores on a scale||Standard Deviation|Mean
2582243|NCT02380859|Other Pre-specified|Change in Activities of Daily Living - Falls Efficiency|"Average change in score evaluated using the Falls Efficiency Scale. This ten-item questionnaire asks people to rate their confidence in performing daily activities without falling. Responses are given on a scale from 0 (very confident) to 10 (not very confident) and a total score out of 100 is computed."|Baseline (Day 0) and Day 15||||scores on a scale||Standard Deviation|Mean
2582244|NCT02380859|Other Pre-specified|Change in Activities of Daily Living - New Freezing of Gait|Average change in score relating to new freezing of gate utilizing the New Freezing of Gait Questionnaire. This nine-item questionnaire detects and evaluates the impact and severity of freezing of gait on locomotion and daily activities. Items are scored from 0 or 1 to 3 or 4, with higher numbers indicating greater impact and severity. A total score out of 28 is calculated.|Baseline (Day 0) and Day 15||||scores on a scale||Standard Deviation|Mean
2582245|NCT02380859|Secondary|Change in Gait - Functional Gait Assessment|"Functional Gait Assessment. This 10-item test assesses dynamic balance and postural stability during gait. Items consist of specific walking tasks such as stepping over an obstacle, changing speed of walking upon the assessor's instruction, and walking backwards. The assessor scores the patient's performance from 0 (severe impairment) to 3 (normal) and a total is calculated out of 30."|Baseline (Day 0) and Day 15||||scores on a scale||Standard Deviation|Mean
2582246|NCT02380859|Secondary|Change in Gait - Timed Up and Go Task|Timed Up and Go Test (TUG). Patients are seated in a chair and instructed to stand up, walk three meters, turn around, walk back, and sit down. The time (in seconds) is recorded.|Baseline (Day 0) and Day 15||||seconds||Standard Deviation|Mean
2582247|NCT02380859|Secondary|Change in Gait - Step Speed in the Walk Across (SMART Equitest Balance Master)|The WA quantifies characteristics of gait as the patient walks across the length of the force plate. The test characterizes steady state gait by having the patient begin well behind and continuing beyond the force plate. Measured parameters are average step width, average step length, speed and step length symmetry.|Baseline (Day 0) and Day 15||||cm/s||Standard Deviation|Mean
2582248|NCT02380859|Secondary|Change in Gait - Step Length on the Walk Across Test (SMART Equitest Balance Master)|The WA quantifies characteristics of gait as the patient walks across the length of the force plate. The test characterizes steady state gait by having the patient begin well behind and continuing beyond the force plate. Measured parameters are average step width, average step length, speed and step length symmetry.|Baseline (Day 0) and Day 15||||cm||Standard Deviation|Mean
2582249|NCT02380859|Primary|Change in Postural Control - Composite Score on the Sensory Organisation Test SMART EquiTest Balance Master|"The participant is asked to maintain an upright posture under six different conditions of sensory feedback:~Condition 1:Normal vision, fixed support~Condition 2:Absent vision, fixed support~Condition 3:Sway-referenced vision, fixed support~Condition 4:Normal vision, sway-referenced support~Condition 5:Absent vision, sway-referenced support~Condition 6:Sway-referenced vision, sway-referenced support~The equilibrium score for each condition compares the subject's anterior/posterior (AP) sway during each trial to the theoretical sway stability limit of 12.5 degrees. A composite equilibrium score (0-100, higher score indicates better outcome) quantifies the overall COG sway or postural stability across the sensory conditions and is calculated by:~Independently averaging the score for conditions 1 and 2;~Adding these two scores to the equilibrium scores from each trial of sensory conditions 3, 4, 5, and 6; and~Dividing that sum by the total number of trials."|Baseline (Day 0) and Day 15||||change in percentage||Standard Deviation|Mean
2582250|NCT02380859|Primary|Change in Postural Control - Maximum Extension on the Limits of Stability Test (Smart Equitest Balance Master System)|The participant stood on the platform in front of a monitor. Nine squares were presented on the monitor representing locations relative to the upright starting position: one in the centre of the screen (upright) and the remaining eight forming an ellipse around the central square. The participant's COG was indicated on the screen by the position of a stick figure avatar. At the beginning of each trial the participant was instructed to stand upright, keeping the COG cursor over the central target. A circular target appeared in one of eight other targets. The participant was required to move the COG cursor towards the second target as quickly and as accurately as possible by leaning their body while keeping their feet in the same location, and to then hold a position as close to the target as possible. Maximum extension of the COG over the feet was recorded for 8 trials per location.|Baseline (Day 0) and Day 15|Average change in Maximum Extension between baseline and day 15|||meters||Standard Deviation|Mean
2582251|NCT02380859|Primary|Change in Postural Control - Maximum Velocity on the Limits of Stability Test (Smart Equitest Balance Master System)|The participant stood on the platform in front of a monitor. Nine squares were presented on the monitor representing locations relative to the upright starting position: one in the centre of the screen (upright) and the remaining eight forming an ellipse around the central square. The participant's COG was indicated on the screen by the position of a stick figure avatar. At the beginning of each trial the participant was instructed to stand upright, keeping the COG cursor over the central target. A circular target appeared in one of eight other targets. The participant was required to move the COG cursor towards the second target as quickly and as accurately as possible by leaning their body while keeping their feet in the same location, and to then hold a position as close to the target as possible. Maximum velocity was recorded for 8 trials per location.|Baseline (Day 0) and Day 15|Average change time; mean change (post-pre) meters per second|||meters per second||Standard Deviation|Mean
2582252|NCT02380859|Primary|Change in Postural Control - Reaction Time on the Limits of Stability Test (Smart Equitest Balance Master System)|The participant stood on the platform in front of a monitor. Nine squares were presented on the monitor representing locations relative to the upright starting position: one in the centre of the screen (upright) and the remaining eight forming an ellipse around the central square. The participant's COG was indicated on the screen by the position of a stick figure avatar. At the beginning of each trial the participant was instructed to stand upright, keeping the COG cursor over the central target. A circular target appeared in one of eight other targets. The participant was required to move the COG cursor towards the second target as quickly and as accurately as possible by leaning their body while keeping their feet in the same location, and to then hold a position as close to the target as possible. Reacting times were recorded for 8 trials per location. Mean change (post-pre) in seconds|Baseline (Day 0) and Day 15||||Seconds||Standard Deviation|Mean
2582253|NCT02380742|Secondary|VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain|Practitioner's perception of patient's pain score at time of pessary insertion adjusting for baseline pain. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)|Insertion of Pessary|After baseline and removal study activities were recorded, one of the patients in the placebo group was withdrawn by the investigator due to vaginal erosion.|||Centimeters||Standard Error|Least Squares Mean
2582254|NCT02380742|Secondary|VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age|Self-reported pain intensity at time of pessary removal after controlling for patient age and baseline pain score. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)|Removal of Pessary||||Centimeters||Standard Error|Least Squares Mean
2582255|NCT02380742|Secondary|VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training|Self-reported pain intensity at time of pessary removal after controlling for pessary type and investigator training level. Scale is from 0 to 10 centimeters (0=no pain and 10=worst pain)|Removal of Pessary||||Centimeters||Standard Error|Least Squares Mean
2582256|NCT02380742|Primary|VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain|Self-reported pain intensity at time of pessary removal controlling for baseline pain. Scale is from 0 to 10 (0=no pain and 10=worst pain)|Removal of Pessary||||Centimeters||Standard Error|Least Squares Mean
2582257|NCT02380287|Other Pre-specified|Frequency of Binding Antibodies to BCD-85 Formation||day 57|||||||
2582258|NCT02380287|Other Pre-specified|Frequency of Early Discontinuation Due to AE||57 days|||||||
2582259|NCT02380287|Other Pre-specified|Frequency of Grade 3-4 AEs||57 days|||||||
2582260|NCT02380287|Other Pre-specified|Frequency of Local Reactions||57 days|||||||
2582261|NCT02380287|Other Pre-specified|Total Frequency of AE/SAE||57 days|||||||
2582262|NCT02380287|Other Pre-specified|Mean Pain Score by VAS Assessment During Injection of BCD-085||day 1|||||||
2582263|NCT02380287|Other Pre-specified|Clearance of BCD-085 After Single Subcutaneous Injection||57 days|||||||
2582264|NCT02380287|Other Pre-specified|Constant of Elimination of BCD-085 After Single Subcutaneous Injection||57 days|||||||
2582265|NCT02380287|Other Pre-specified|Half-life of BCD-085 After Single Subcutaneous Injection||57 days|||||||
2582266|NCT02380287|Other Pre-specified|Time of Maximum Concentration of BCD-085 After Single Subcutaneous Injection||57 days|||||||
2582267|NCT02380287|Secondary|Maximum Concentration of BCD-085 After Single Subcutaneous Injection||57 days|||||||
2582268|NCT02380287|Primary|Area Under the Plasma Concentration of BCD-085-time Curve From Zero (0) Hours to 1320 Hours After the Single Subcutaneous Injection of BCD-085||57 days||||(ng/ml)*hour||Inter-Quartile Range|Median
2582269|NCT02380261|Primary|Number of Participants With Ocular Clinical Signs and Discomfort Sensations|Participants were assessed by an ophthalmologist. Ocular clinical signs included palpebral edema, conjunctival edema, orbicular secretion, keratoconus, blepharitis, meibomitis, pterygium, hyperemia, chemosis, keratitis, secretion and lacrimation. Both eyes contributed to the analysis.|Day 21|This analysis population includes all enrolled participants.|||participants|||Number
2582270|NCT02380261|Primary|Number of Participants With a Contact-dermatitis Adverse Reaction|Participants were assessed by a dermatologist. Contact-dermatitis adverse reaction was characterized by the presence of one or more of the following symptoms or signs: strong itching sensation, erythema, edema, desquamation, papules or vesicles. Both eyes contributed to the analysis.|Day 21|This analysis population includes all enrolled participants.|||participants|||Number
2582271|NCT02380248|Primary|Change From Baseline in Corneal Staining at All Study Time Points|Corneal staining was assessed by the Investigator through slit-lamp examination and reported on a scale of 0-3, where 0=normal (no staining) and 3=severe (numerous coalescent macropunctate areas and/or patches), for the 5 quadrants of each eye. The scores at each visit were summed by eye for each subject. The overall corneal staining score for the subject at each visit was then computed as the average of the sum from both eyes. Thus, the overall scores ranged between 0-15 with higher scores reflecting more damage to the corneal surface.|Baseline (Day 0), Day 45, Day 90|Full Analysis Set. Number analyzed includes number of subjects with non-missing response in specified category.|||units on a scale||Standard Error|Mean
2582272|NCT02380183|Secondary|Nerve Block Procedure Time|How long the procedure takes in minutes, starting from ultrasound contact with skin to needle withdrawal.|time from ultrasound contact with skin to needle withdrawal, up to 20 minutes||||seconds||Inter-Quartile Range|Median
2582273|NCT02380183|Primary|Needle Time;|needle insertion to needle withdrawal|Needle insertion to needle withdrawal, up to 20 minutes||||seconds||Inter-Quartile Range|Median
2582274|NCT02379923|Secondary|Procedural Success (Evaluated According to Crossing Technique)|The percentage of subjects with procedure success according to crossing technique|Through hospital discharge||||Participants|||Count of Participants
2582275|NCT02379923|Secondary|Mean Absorbed Radiation Dose in mGy|Absorbed radiation dose in mGy during procedure|During Procedure|Data recorded for 161 of 163 subjects|||milligray (mGy)||Standard Deviation|Mean
2582276|NCT02379923|Secondary|Mean Contrast Volume|Volume of contrast administered during procedure|During Procedure||||milliliters||Standard Deviation|Mean
2582277|NCT02379923|Secondary|Mean Procedural Time|The length of the procedure (The first successful insertion of the guide catheter at an arteriotomy site is considered the start of the procedure. A procedure is considered complete once the guide catheter is removed from the arteriotomy site.)|During Procedure|Data collected for 162 of 163 subjects|||minutes||Standard Deviation|Mean
2582278|NCT02379923|Secondary|Frequency of Dissection|Frequency of dissection reported during the procedure|During procedure||||Participants|||Count of Participants
2582279|NCT02379923|Secondary|Frequency of Perforation|Frequency of perforation during the procedure.|During Procedure||||Participants|||Count of Participants
2582280|NCT02379923|Secondary|Frequency of In-hospital MACE|Any serious adverse experience that includes cardiac death; target lesion revascularization; or post-procedural MI.|Up to hospital discharge||||Participants|||Count of Participants
2582281|NCT02379923|Secondary|Frequency of Successful Recanalization|Angiographic confirmation of crossing the chronic total occlusion and restoring blood flow to the affected area.|During Procedure||||Participants|||Count of Participants
2582282|NCT02379923|Primary|Procedure Success|Angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access and the absence of in-hospital MACE.|Through hospital discharge, typically 24 hours post procedure||||Participants|||Count of Participants
2582283|NCT02379858|Secondary|30-day Treatment Related Morbidity and Re-admission Rates|Treatment (study drug) and surgery (complications as a direct result of surgery) related morbidity and re-admission rates will be assessed from the time surgery is completed to 30-days post-operatively. Treatment related morbidity and re-admission rates include: post-operative ileus (POI), indigestion and any event determined by the attending physician to be directly related to treatment (study drug). Surgical complications include: hernia recurrence, infections, and any event determined by the attending physician to be directly related to surgery.|Participants will be followed for the duration of hospital stay to 30 days after surgery, an expected average of 6 weeks||||morbidity or readmission||Standard Deviation|Mean
2582284|NCT02379858|Secondary|Length of Hospital Stay|Length of stay will be measured in hours from the time that surgery is completed until the hospital discharge order is written (hrs/days).|Participants will be followed for the duration of hospital stay, an expected average of 1 week||||Days||Standard Deviation|Mean
2582285|NCT02379858|Primary|Length of Time (Hrs/Days) to Gastrointestinal Tract Recovery|"Time to gastrointestinal recovery will be measured by the following:~Time to first flatus and time to first bowel movement measured twice daily. Toleration of a diet and toleration of oral pain medication defined as ingestion of diet or medications that occurs without vomiting or significant nausea for four hours following ingestion.~GI-2 recovery defined as both toleration of solid food and occurrence of first bowel movement. GI-3 recovery is defined as toleration of solid food and either occurrence of first flatus or occurrence of first bowel movement.~Patients requiring nasogastric tube insertion, requiring reduction or restriction of diet, having episodes of emesis, and/or needing initiation of Total Parenteral Nutrition (TPN) will be recorded. VAS (visual analog pain scale), nausea, and bloating will be recorded by nursing staff at least twice daily. The number of doses of anti-nausea medication administered during the hospitalization will also be recorded."|Participants will be followed for the duration of hospital stay, an expected average of 1 week.||||Days||Standard Deviation|Mean
2582286|NCT02379728|Other Pre-specified|Body Position Sensor Participant Sleep Time by Position|"Body Position Sensor (BPS) data (position - left, right, supine, prone - and time stamp) will be collected from participants in the PrenaBelt with BPS and Control with BPS Arms when she returns the BPS to study personnel after the delivery of her baby."|Throughout third trimester (on average, from 28 through 40 weeks gestation)|Of 32 participants (16 PrenaBelt, 16 sham) in the BPS cohort, 23 (14 PrenaBelt, 9 sham) had complete datasets for analysis.|||% of total sleep time||Inter-Quartile Range|Median
2582287|NCT02379728|Other Pre-specified|Body Position Sensor Participant Time Used Per Night|"Body Position Sensor (BPS) data (position - left, right, supine, prone - and time stamp) will be collected from participants in the PrenaBelt with BPS and Control with BPS Arms when she returns the BPS to study personnel after the delivery of her baby."|Throughout third trimester (on average, from 28 through 40 weeks gestation)|Of 32 participants (16 PrenaBelt, 16 sham) in the BPS cohort, 23 (14 PrenaBelt, 9 sham) had complete datasets for analysis.|||hours||Inter-Quartile Range|Median
2582288|NCT02379728|Other Pre-specified|Body Position Sensor Participant Adherence|"Body Position Sensor (BPS) data (position - left, right, supine, prone - and time stamp) will be collected from participants in the PrenaBelt with BPS and Control with BPS Arms when she returns the BPS to study personnel after the delivery of her baby."|Throughout third trimester (on average, from 28 through 40 weeks gestation)|Of 32 participants (16 PrenaBelt, 16 sham) in the BPS cohort, 23 (14 PrenaBelt, 9 sham) had complete datasets for analysis.|||% of days||Inter-Quartile Range|Median
2582289|NCT02379728|Other Pre-specified|Sleep Diary - Number of Nights Used Device|"Participants in all study arms will be instructed to use the PrenaBelt/sham-PrenaBelt (device) every night for the remainder of the pregnancy and will be given a simple Sleep Diary to track their nightly device use. The sleep diary will be returned to the study personnel by the participant after the delivery of her baby. By checking the box in her sleep diary for each night she uses the device (and, conversely, not checking the box for each night she does not use the device), adherence (the proportion of nights the device was used) to device use will be calculated."|Throughout third trimester (on average, from 28 through 40 weeks gestation)|143 participants (68 treatments, 75 shams) completed and returned the sleep diary.Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.|||Number of nights used device||Standard Deviation|Mean
2582290|NCT02379728|Other Pre-specified|Sleep Diary - Number of Nights in Trial|"Participants in all study arms will be instructed to use the PrenaBelt/sham-PrenaBelt (device) every night for the remainder of the pregnancy and will be given a simple Sleep Diary to track their nightly device use. The sleep diary will be returned to the study personnel by the participant after the delivery of her baby. By checking the box in her sleep diary for each night she uses the device (and, conversely, not checking the box for each night she does not use the device), adherence (the proportion of nights the device was used) to device use will be calculated."|Throughout third trimester (on average, from 28 through 40 weeks gestation)|143 participants (68 treatments, 75 shams) completed and returned the sleep diary.Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.|||Number of nights in trial||Standard Deviation|Mean
2582291|NCT02379728|Other Pre-specified|Sleep Diary - PrenaBelt Adherence|"Participants in all study arms will be instructed to use the PrenaBelt/sham-PrenaBelt (device) every night for the remainder of the pregnancy and will be given a simple Sleep Diary to track their nightly device use. The sleep diary will be returned to the study personnel by the participant after the delivery of her baby. By checking the box in her sleep diary for each night she uses the device (and, conversely, not checking the box for each night she does not use the device), adherence (the proportion of nights the device was used) to device use will be calculated."|Throughout third trimester (on average, from 28 through 40 weeks gestation)|143 participants (68 treatments, 75 shams) completed and returned the sleep diary.Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.|||% (#nights used/#nights in trial)||Standard Deviation|Mean
2582292|NCT02379728|Other Pre-specified|PrenaBelt User Feedback Questionnaire - Intention for Future Use|"On a scale of 1 to 10, participant's intention to use the PrenaBelt during a subsequent pregnancy if it was available to her.~Note:~1 = participant would never use it again 5-6 = participant would consider using it again 10 = participant would certainly use it again"|At delivery of baby (on average, 38 - 40 weeks gestation)|Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.|||units on a scale||Inter-Quartile Range|Median
2582293|NCT02379728|Other Pre-specified|PrenaBelt User Feedback Questionnaire - Comfort|"On a scale of 1 to 10, participant's level of comfort while wearing and sleeping with the PrenaBelt.~Note:~1 = extremely uncomfortable 5-6 = acceptable 10 = extremely comfortable"|At delivery of baby (on average, 38 - 40 weeks gestation)|Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.|||units on a scale||Inter-Quartile Range|Median
2582294|NCT02379728|Other Pre-specified|PrenaBelt User Feedback Questionnaire - Satisfaction|"On a scale of 1 to 10, participant's level of satisfaction with the PrenaBelt.~Note:~1 = extremely dissatisfied 5-6 = acceptable 10 = extremely satisfied"|At delivery of baby (on average, 38 - 40 weeks gestation)|Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.|||units on a scale||Inter-Quartile Range|Median
2582295|NCT02379728|Other Pre-specified|PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep|"In general, did the participant notice anything else that was different about her sleep when using the PrenaBelt.~Check box categories:~Participant's sleep quality improved. Participant's sleep quality worsened. Participant's sleep duration became longer. Participant's sleep duration became shorter. During the day, participant felt more alert. During the day, participant felt more drowsy. Participant stopped snoring. Participant started snoring. Participant woke up less often throughout the night.~Other, please specify:"|At delivery of baby (on average, 38 - 40 weeks gestation)|Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.|||Participants|||Count of Participants
2582307|NCT02379728|Other Pre-specified|Medical Staff Questionnaire - Session Difficulties|Did the medical staff person or the participants encounter any difficulties during the Introduction and Instruction for PrenaBelt sessions (yes/no; if yes, describe)|From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)|All four maternity personnel conducting the device introduction sessions completed this question on the maternity personnel questionnaire.|||Participants|||Count of Participants
2582335|NCT02379390|Secondary|Pain Response Using Brief Pain Inventory-Short Form (BPI-SF) for Pain Intensity Score|Pain response was analyzed using the brief pain inventory-short form (BPI-SF).|Baseline until the end of study (maximum duration: 1059 days)|Planned analysis could not be performed due to early study termination.||||||
2582296|NCT02379728|Other Pre-specified|PrenaBelt User Feedback Questionnaire - Perception of Effect on Sleep Position|"How does the participant think the PrenaBelt affected her sleep position.~Check box categories:~Participant didn't notice any difference in her sleep position Participant changed position more often. Participant spent more time sleeping on her left side. Participant woke up more often during the night when she was on her back, would roll back onto her left side, and fall asleep.~Over time, participant learned to not sleep on her back and woke up less at night.~In the mornings, participant always woke up on her left side.~Other, please specify:"|At delivery of baby (on average, 38 - 40 weeks gestation)|Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.|||Participants|||Count of Participants
2582297|NCT02379728|Other Pre-specified|PrenaBelt User Feedback Questionnaire - Other Uses|Did the participant or anyone else use the PrenaBelt for anything else during daily activities besides sleep (yes/no; if yes, explain).|At delivery of baby (on average, 38 - 40 weeks gestation)|Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.|||Participants|||Count of Participants
2582298|NCT02379728|Other Pre-specified|PrenaBelt User Feedback Questionnaire - Deterrents to Use|Did anyone tell the participant to stop using the PrenaBelt or that she should not be using the PrenaBelt (yes/no; if yes, explain)|At delivery of baby (on average, 38 - 40 weeks gestation)|Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.|||Participants|||Count of Participants
2582299|NCT02379728|Other Pre-specified|PrenaBelt User Feedback Questionnaire - Nights of Use Per Week|"When the participant was using the PrenaBelt, did she use it:~Check box categories:~Every night of the week. 6 nights per week. 7 nights per week. 5 nights per week. 4 nights per week. 3 nights per week. 2 nights per week.~1 nights per week. Did not use it at all."|At delivery of baby (on average, 38 - 40 weeks gestation)|Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.|||Participants|||Count of Participants
2582300|NCT02379728|Other Pre-specified|PrenaBelt User Feedback Questionnaire - General Adherence Pattern|"Did the participant use the PrenaBelt regularly (almost every night)?~Check box categories:~Regularly throughout her entire third trimester. More regularly at the beginning and less at the end. Less regularly at the beginning and more at the end. Not regularly at any time."|At delivery of baby (on average, 38 - 40 weeks gestation)|Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.|||Participants|||Count of Participants
2582301|NCT02379728|Other Pre-specified|PrenaBelt User Feedback Questionnaire - Learning|"When the participant was introduced to and instructed how to use the PrenaBelt by the medical staff, how difficult was it to learn how to use the PrenaBelt?~Check box categories:~Easy - participant did not have to ask any questions. Medium - participant had some questions. Difficult - participant had many questions and could not put the PrenaBelt on correctly."|At delivery of baby (on average, 38 - 40 weeks gestation)|Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.|||Participants|||Count of Participants
2582302|NCT02379728|Other Pre-specified|PrenaBelt User Feedback Questionnaire - Understanding|"When the participant was introduced to and instructed how to use the PrenaBelt by the medical staff, how difficult was it to understand the PrenaBelt?~Check box categories:~Easy - participant did not have to ask any questions. Medium - participant had some questions. Difficult - participant had many questions and could not understand it."|At delivery of baby (on average, 38 - 40 weeks gestation)|Per protocol, the PrenaBelt User Feedback Questionnaire was only administered to participants in the Arms/Groups with the PrenaBelt (n=82). 55 of these 82 completed the Questionnaire. The BPS was not expected to affect responses to the Questionnaire, so these Arms/Groups with the PrenaBelt were combined. No arms are missing from the entered data.|||Participants|||Count of Participants
2582303|NCT02379728|Other Pre-specified|Medical Staff Questionnaire - Professional Difficulty Rating|"In comparison to the medical staff person's training and experience, the difficulty rating of delivering the sessions on a scale from 1 to 10:~1 = Easy - medical staff person could have completed the sessions without training and experience.~5 = Medium difficulty - medical staff person needed to use some professional training and experience.~10 = Very difficult - professional training and experience did not help medical staff person at all"|From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)|Four maternity personnel conducting the device introduction sessions completed this question on the maternity personnel questionnaire.|||units on a scale||Full Range|Mean
2582304|NCT02379728|Other Pre-specified|Medical Staff Questionnaire - Professional Experience|The professional experience (years working as a professional) of the medical staff person.|From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)|Four maternity personnel conducting the device introduction sessions completed this question on the maternity personnel questionnaire.|||years||Full Range|Mean
2582305|NCT02379728|Other Pre-specified|Medical Staff Questionnaire - Professional Training Level|The professional training level (e.g., nursing, midwifery) of the medical staff person.|From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)|All four maternity personnel conducting the device introduction sessions completed this question on the maternity personnel questionnaire.|||Participants|||Count of Participants
2582308|NCT02379728|Other Pre-specified|Medical Staff Questionnaire - Session Delivery|How the medical staff person delivered the Introduction and Instruction for PrenaBelt session (e.g., one-on-one, in a group setting, or both) and the staff person's preference for delivery.|From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)|All four maternity personnel conducting the device introduction sessions completed this question on the maternity personnel questionnaire.|||Participants|||Count of Participants
2582309|NCT02379728|Other Pre-specified|Medical Staff Questionnaire - Session Time Requirement|How long it took (in minutes), on average, to complete the Introduction and Instruction for PrenaBelt session.|From first Introduction and Instruction for PrenaBelt session until the last session (approximately 7 months)|Three, of four, maternity personnel conducting the device introduction sessions answered this question on the maternity personnel questionnaire.|||minutes||Full Range|Mean
2582310|NCT02379728|Secondary|Received ≥ 1 Obstetrical Diagnosis During Labor/Delivery|Any relevant diagnosis/diagnoses made during labor/delivery (e.g., gestational diabetes, gestational hypertension, meconium aspiration) will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.|At delivery of baby (on average, 38 - 40 weeks gestation)|12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.|||Participants|||Count of Participants
2582311|NCT02379728|Secondary|Preterm Delivery|Preterm delivery was defined as a gestational age (in weeks) at birth of less than 37 weeks, 0 days.|At delivery of baby (on average, 38 - 40 weeks gestation)|12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.|||Participants|||Count of Participants
2582312|NCT02379728|Secondary|Small for Gestational Age|Small for gestational age is defined as a Gestation-Related Optimal Weight (GROW) birthweight centile ≤ 10%.|At delivery of baby (on average, 38 - 40 weeks gestation)|12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.|||Participants|||Count of Participants
2582313|NCT02379728|Secondary|Low Birthweight|Low birthweight is defined as a birthweight ≤ 2500 grams at birth.|At delivery of baby (on average, 38 - 40 weeks gestation)|12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.|||Participants|||Count of Participants
2582314|NCT02379728|Secondary|Stillbirth|If a stillbirth occurs, it will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.|At delivery of baby (on average, 38 - 40 weeks gestation)|12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.|||Participants|||Count of Participants
2582315|NCT02379728|Secondary|Sex of Newborn (Male/Female)|Sex of the newborn will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.|At delivery of baby (on average, 38 - 40 weeks gestation)|12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.|||Participants|||Count of Participants
2582316|NCT02379728|Secondary|Mode of Delivery|Mode of delivery (unassisted, episiotomy, amniotomy, induced, fetal monitoring, forceps delivery, vacuum extraction, Cesarean section) will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.|At delivery of baby (on average, 38 - 40 weeks gestation)|12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.|||Participants|||Count of Participants
2582317|NCT02379728|Secondary|Gestational Age at Delivery|Gestational age at delivery (weeks) will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.|At delivery of baby (on average, 38 - 40 weeks gestation)|12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.|||Weeks||Inter-Quartile Range|Median
2582318|NCT02379728|Primary|Birthweight Centile|"Birthweight centile was calculated using the Gestation-Related Optimal Weight (GROW) software,(1,2) which accounts for the main non-pathological factors affecting birthweight (gestational age, maternal height, maternal weight at booking, parity, ethnicity, and sex of the neonate) and, as such, enables delineation between constitutional and pathological smallness and more accurate detection of pregnancies at increased risk for adverse outcomes.(3,4) This was an additional trial outcome specified after trial commencement.~Gardosi J, Francis A. Customized Weight Centile Calculator. Gestation Network; 2016. Available from: www.gestation.net~Gardosi J, et al. Customised antenatal growth charts. Lancet. Elsevier; 1992 Feb;339(8788):283-7.~Gardosi J. Horm Res. 2006;65(SUPPL. 3):15-8.~Odibo A O, et al. J Matern Neonatal Med. 2011 Mar 10; 24(3):411-7."|At delivery of baby (on average, 38 - 40 weeks gestation)|12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.|||percent||Inter-Quartile Range|Median
2582319|NCT02379728|Primary|Birthweight of Baby|"Birthweight was measured using a Detecto newborn scale (Webb City, USA) and documented in the participant's hospital folder immediately after delivery by a midwife who was not a part of the study team and was not aware of the treatment allocation. Birthweight was subsequently abstracted by the blinded outcomes assessor.~Analysis was by original assigned groups and on a complete-case basis (drop-outs excluded). The newborns included in the final analysis were born from November 31, 2015 through May 13, 2016."|At delivery of baby (on average, 38 - 40 weeks gestation)|12 PrenaBelt and 7 sham participants excluded from analysis population. Two arms: PrenaBelt (participants with and without BPS) and Control (participants with and without BPS). BPS was not expected to affect body position. We did not intend readers would interpret this as 4 different treatments. No arms are missing from the entered data.|||grams||Standard Deviation|Mean
2582320|NCT02379637|Secondary|Safety of Daily Dose of NAC (Number of Patients With Adverse Advents)|Number of patients with adverse advents|7 Days||||participants|||Number
2582321|NCT02379637|Primary|Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours)|Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours|72 hours|Full Analysis set|||log-transformed total cough count||Standard Deviation|Mean
2582322|NCT02379585|Secondary|Plasma Blood-based Tumor-related Abnormalities in DNA|To investigate changes in plasma blood-based tumor-related abnormalities in DNA after short-term fasting and chemotherapy|4-6 cycles (up to 12 weeks)|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
2582323|NCT02379585|Secondary|Changes in Insulin-like Growth Factor-1|To investigate changes in Insulin-like growth factor-1 (IGF1) after short-term fasting and chemotherapy|4-6 cycles (up to 12 weeks)|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
2582324|NCT02379585|Secondary|Glucose After Fasting and Chemotherapy|To investigate changes in glucose after short-term fasting and chemotherapy|4-6 cycles (up to 12 weeks)|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
2582325|NCT02379585|Secondary|Nutritional Assessment Before and After Neoadjuvant Chemotherapy|Nutritional status assessment with Patient Generated Subjective Global Assessment (aPG-SGA) before and after neoadjuvant chemotherapy|4-6 cycles (up to 12 weeks)|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
2582326|NCT02379585|Secondary|Biomarker Changes Before and After Chemotherapy|Biomarker changes in breast cancer (biopsy or residual tumor) before and after neoadjuvant chemotherapy|4-6 cycles (up to 12 weeks)|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
2582327|NCT02379585|Secondary|Insulin Abnormalities|Changes in plasma insulin abnormalities after short-term fasting and chemotherapy|4-6 cycles (up to 12 weeks)|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
2582328|NCT02379585|Secondary|Pathological Response Rate at the Time of Surgery or Time of Biopsy Upon Completion of Planned Chemotherapy|To evaluate pathological complete remission rate (defined as disappearance of all invasive tumor in the breast; ypT0-is) at the time of surgery, or partial pathological response rate (defined as residual invasive disease of 1cm, ypT1a-b) at the time of surgery or at the time of biopsy upon completion of planned chemotherapy for triple-negative breast cancer.|4-6 cycles|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
2582329|NCT02379585|Secondary|Fasting on the Toxicity of Neoadjuvant Chemotherapyaccording to the NCI|The effect of short-term fasting on the toxicity of neoadjuvant chemotherapy in breast cancer patients according to the NCI common toxicity criteria (Version 4.03)|4-6 cycles (up to 12 weeks)|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
2582330|NCT02379585|Primary|Pathological Response Rate at the Time of Surgery or at the Time of Biopsy|Evaluate pathological complete remission rate at the time of surgery, or partial pathological response rate (defined as residual invasive disease of 1cm) at the time of surgery or at the time of biopsy upon completion of planned chemotherapy.|4-6 cycles (up to 12 weeks)|Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information. After much effort, results were not able to be retained.||||||
2582331|NCT02379442|Primary|Proportion of Subjects Without a Treatment Related Severe Adverse Event|The number of subjects without a treatment related severe adverse event (TRSAE) within 56 days of treatment.|56 days||||Participants|||Count of Participants
2582332|NCT02379390|Secondary|Time to Occurrence of Any Symptomatic Skeletal Events (SSE)|Time to SSE was defined as the time interval between the date of randomization and the date of the occurrence of the first event defining a SSE, whichever is earlier.|Baseline up to occurrence of the first event defining a SSE (maximum duration: 1059 days)|Planned analysis could not be performed due to early study termination.||||||
2582333|NCT02379390|Secondary|Percentage of Participants With Symptomatic Skeletal Event (SSE)|SSE was the occurrence of a new symptomatic pathological fracture, or the use of external beam radiation to relieve bone pain, or the occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention.|Baseline until the end of study (maximum duration: 1059 days)|Planned analysis could not be performed due to early study termination.||||||
2582334|NCT02379390|Secondary|Time to Pain Progression|Time to pain progression was defined as the time interval between the date of randomization and the date of the first documented pain progression.|Baseline until disease progression, start of another anticancer therapy or study cut off, whichever came first (maximum duration: 1059 days)|Planned analysis could not be performed due to early study termination.||||||
2582336|NCT02379390|Secondary|Duration of Tumor Response|Duration of tumor response was defined as the time between the first evaluation at which the tumor response criteria were met and the first documentation of tumor progression.|Baseline up to disease progression or death due to any cause (maximum duration: 1059 days)|Planned analysis could not be performed due to early study termination.||||||
2582337|NCT02379390|Secondary|Number of Participants Achieving Tumor Response|Tumor response was defined as either a partial response (PR) or complete response (CR) according to the RECIST 1.1.|Baseline up to disease progression or death due to any cause (maximum duration: 1059 days)|Planned analysis could not be performed due to early study termination.||||||
2582338|NCT02379390|Secondary|Time to PSA Progression|Time to PSA progression was defined as the time interval between the date of randomization and the date of first documented PSA progression as per PCWG2 criteria.|Baseline up to PSA progression or death due to any cause (maximum duration: 1059 days)|Planned analysis could not be performed due to early study termination.||||||
2582339|NCT02379390|Secondary|Overall Survival|Overall Survival was defined as the time interval from the date of randomization to the date of death due to any cause.|Baseline until death or study cut-off date, whichever was earlier (maximum duration: 1059 days)|Planned analysis could not be performed due to early study termination.||||||
2582340|NCT02379390|Secondary|Progression-free Survival (PFS)|PFS: time interval between date of randomization to first documentation of tumor progression as per RECIST 1.1.|Baseline upto progression or death due to any cause (maximum duration: 1059 days)|Planned analysis could not be performed due to early study termination.||||||
2582341|NCT02379390|Secondary|Number of Participants With Prostate Specific Antigen (PSA) Response|PSA response was defined as decline of serum PSA from baseline by >= 50 percent (%).|Baseline up to PSA progression or death due to any cause (maximum duration: 1059 days)|Planned analysis could not be performed due to early study termination.||||||
2582342|NCT02379390|Primary|Radiographic Progression-Free Survival (rPFS)|rPFS was defined as the time from randomization to the first occurrence of radiological tumor progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or progression of bone lesions using prostate cancer working group 2 (PCWG2) criteria or death due to any cause.|Baseline until tumor progression or bone lesion progression or death due to any cause (maximum duration: 1059 days)|Planned analysis could not be performed due to early study termination.||||||
2582343|NCT02379221|Secondary|Mean Pain Level Associated With Facial Filler Injection to the Nasolabial Fold|Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during injection of HA filler to the nasolabial fold. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm|5-10 minutes post procedure||||units on a scale||Standard Deviation|Mean
2582344|NCT02379221|Secondary|Mean Pain Level Associated With Facial Filler Injection to the Lower Lip|A mean level of pain for all participants completing the Visual Analog Scale (VAS) during injection of HA filler to the lower lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm. The total score was divided by 48.|5-10 minutes post procedure||||units on a scale||Standard Deviation|Mean
2582345|NCT02379221|Secondary|Mean Pain Level Associated With Facial Filler Injection at the Upper Lip|Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during injection of HA filler to the upper lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm|5-10 minutes post procedure||||units on a scale||Standard Deviation|Mean
2582346|NCT02379221|Secondary|Mean Pain Level Associated With the Local Topical Anesthetic|Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during application of topical anesthesia to the upper and lower lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm|5-10 min post procedure||||units on a scale||Standard Deviation|Mean
2582347|NCT02379221|Secondary|Mean Pain Level Associated With the Local Anesthetic Injection|Participant will complete a questionnaire to evaluate his/her pain level perception using a Visual Analog Scale (VAS) during injection to the upper and lower lip. The Visual Analog scale uses a 10 cm horizontal line with 'no pain' labeled on the left end of line and 'worst pain' on the right end of line. Participant marks their pain level at any point on the line from no pain to worst pain. No pain= 0 cm, Worst pain=10cm|5-10 minutes post-procedure||||unit on a scale||Standard Deviation|Mean
2582348|NCT02379221|Primary|Participants Anesthetic Preference|Patient will complete a questionnaire to evaluate his/her preference of anesthetic modality.|one week post treatment||||participant preference selection|||Number
2582349|NCT02379195|Secondary|Progression Free Survival|Progression free survival (PFS), defined as the time from treatment initiation to disease progression, relapse or death due to any cause, which ever comes first, will be described with the Kaplan Meier method.|Up to 36 months|12 patients were treated with TIL. 1 patient was not evaluable.|||months||Full Range|Median
2582350|NCT02379195|Secondary|Overall Survival|Overall survival (OS), defined as time from treatment initiation to death, described using the Kaplan Meier method|Up to 36 months|12 patients were treated with TIL. 1 patient was not evaluable.|||months||Full Range|Median
2582351|NCT02379195|Secondary|Objective Response Rate|Clinical responses will be evaluated by RECIST 1.1 (Response Criteria In Solid Tumors Criteria version 1.1) and assessed by CT scan. Complete response (CR), disapperance of all lesions; Partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective response (OR) = CR + PR|Up to 36 months|12 patients were treated with TIL. 1 patient was not evaluable.|||Participants|||Count of Participants
2582352|NCT02379195|Secondary|Treatment Related Immune Responses|Number of participants with detectable in vitro immune responses in the TIL infusion product using intracellular flow cytometry.|Up to 12 months||||Participants|||Count of Participants
2582353|NCT02379195|Primary|Number of Participants With Adverse Events/Serious Adverse Events|Determine the safety of the administration of peginterferon in combination with TIL therapy including lymphodepleting chemotherapy and Interleukin-2 by reporting adverse events according to CTCAE v. 4.0|0-24 weeks|12 patients were treated with TIL.|||Participants|||Count of Participants
2582354|NCT02379117|Secondary|The Control of Eating Questionnaire|The CoEQ is a 21-item questionnaire designed to assess the severity and type of food cravings experienced over the previous 7 days. The CoEQ has four subscales: Craving Control, Craving for Savoury, Craving for Sweet, and Positive Mood. Items on the CoEQ are assessed by 100-mm visual analogue scales [VAS], with items relating to each subscale being averaged to create a final score. High positive mood is better outcome|Healthy volunteer participants will be included in this study for 1 week. Crohn's Disease participants will be included in the study until they are re-assessed in remission. A time limit of 12 months will be given.|||||||
2582355|NCT02379117|Secondary|The Dutch Eating Behaviour Questionnaire|The 33-item DEBQ assesses different eating styles that may contribute to weight gain: emotional eating, external eating, and restraint. 'Emotional eating' occurs in response to emotional arousal states such as fear, anger, or anxiety; 'external eating' occurs in response to external food cues such as sight and smell of food; and 'restraint eating' is overeating after a period of slimming when the cognitive resolve to diet is abandoned. High score means worse outcome|Healthy volunteer participants will be included in this study for 1 week. Crohn's Disease participants will be included in the study until they are re-assessed in remission. A time limit of 12 months will be given.|||||||
2582356|NCT02379117|Secondary|The Power of Food Scale|The PFS is a 15-item questionnaire reflecting the psychological influence of the food environment. It measures appetite for, rather than consumption of, palatable foods and may be a useful measure of the hedonic impact of food environments replete with highly palatable foods. Items are grouped into three domains according to food proximity; food available but not physically present; food present but not tasted; and food tasted but not consumed. High scores mean worse outcome|Healthy volunteer participants will be included in this study for 1 week. Crohn's Disease participants will be included in the study until they are re-assessed in remission. A time limit of 12 months will be given.|||||||
2582357|NCT02379117|Secondary|The Binge Eating Scale|The BES is a 16-item questionnaire that assesses the severity of binge eating tendencies. Eight questions describe the behavioural mani- festations of binge eating behaviour and eight describe the feelings and cognitions associated with binge eating. Scores are summed to produce a total score ranging from 0 to 46. Cut-off points have previously been reported denoting mild [≤17], moderate [18-26], and severe [≥27] binge eating behaviours. High score means worse outcome|Healthy volunteer participants will be included in this study for 1 week. Crohn's Disease participants will be included in the study until they are re-assessed in remission. A time limit of 12 months will be given.|||||||
2582358|NCT02379117|Secondary|Three Factor Eating Questionnaire (TFEQ) Restraint, Disinhibition and Hunger Subscales|The TFEQ contains 51 items and measures three dimensions of human eating behaviour: Cognitive Restraint of Eating [I], Disinhibition [II], and Hunger [III]. Each item scores either 0 or 1 point. The minimum score for factors I, II. and III is therefore 0, with the pos- sible maximum scores being 21, 16, and 14 respectively. High scores mean worse outcome.|Healthy volunteer participants will be included in this study for 1 week. Crohn's Disease participants will be included in the study until they are re-assessed in remission. A time limit of 12 months will be given.|||||||
2582359|NCT02379117|Primary|Dietary Recalls (Calorific Intake)|The primary endpoints for this study will be food intake as measured by one telephone-administered 24-h dietary recall. Total calorific intake will be calculated.|Participants will be included in this study for 1 week||||kcal||Standard Error|Mean
2582360|NCT02379091|Secondary|Percentage of Participants With a Reduction of Pain as Measured Using a Visual Analog Scale (VAS) at Weeks 2, 12 and 24|Reduction of Pain, defined as a ≥40% change from Baseline as measured using a 100 mm Visual Analog Scale (VAS); left end of the line 0=no pain to right end of the line 100=unbearable pain at weeks 2, 12 and 24.|Baseline and Week 2, 12 and 24|Participants from the FAS, all participants in the safety analysis set who had at least 1 valid post-baseline assessment of DAS28-CRP in the double-blind period up to Week 12, with data available for analysis. Number analyzed is the number of participants with data available for analysis at the given time point.|||percentage of participants|||Number
2582361|NCT02379091|Secondary|Change From Baseline in DAS28-CRP at Week 24|The DAS28-CRP score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], general health: patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and acute phase response: C-Reactive Protein (CRP) for a total possible score of 0 (best) to approximately 10 (worst). Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicates improvement.|Baseline and Week 24|Participants from the FAS, all participants in the safety analysis set who had at least 1 valid post-baseline assessment of DAS28-CRP in the double-blind period up to Week 12, with data available for analysis at Baseline and Week 24.|||score on a scale||Standard Deviation|Mean
2582362|NCT02379091|Secondary|Change From Baseline in DAS28-CRP at Weeks 2, 6, and 10|The DAS28-CRP score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], general health: patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and acute phase response: C-Reactive Protein (CRP) for a total possible score of 0 (best) to approximately 10 (worst). Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicates improvement. A MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value as a covariate and participant as a random effect with an unstructured covariance structure was used for analysis.|Baseline and Weeks 2, 6 and 10|FAS includes all participants in the safety analysis set who had at least 1 valid postbaseline assessment of DAS28-CRP in the double-blind period up to Week 12. Number analyzed is the number of participants with data available for analysis at the given time point.|||score on a scale||Standard Error|Least Squares Mean
2582459|NCT02378207|Secondary|Evaluate Humoral Responses Elicited by the Different Vaccine Regimens.|Vaccine-specific binding antibodies elicited by the vaccine regimens as determined by multiplex antibody assay and/or enzyme-linked immunosorbent assay (ELISA).|Up to day 168.|||||||
2582363|NCT02379091|Secondary|ACR Numeric (N) Index (ACRn) at Week 24|ACRn is defined as the lowest % improvement for TJC68, SJC66 and the median of 5 ACR components. These are • Patient's Assessment of Pain over previous 24 hours using a VAS; left end of line 0=no pain to right end of line 100=unbearable pain • Patient's Global Assessment of Disease Activity • Physician's Global Assessment of Disease Activity over previous 24 hours using a VAS where left end of line 0=no disease activity to right end of line 100=maximum disease activity • Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do • Acute-phase reactant: CRP. A positive % change indicates improvement. MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment and visit and previously failed medication and participant used as a random effect with an unstructured covariance structure.|Baseline and Week 24|Participants from the FAS, all participants in the safety analysis set who had at least 1 valid post-baseline assessment of DAS28-CRP in the double-blind period up to Week 12, with data available for analysis. Post-escape data is included.|||percentage change||Standard Deviation|Mean
2582364|NCT02379091|Secondary|ACR Numeric (N) Index (ACRn) at Week 12|ACRn is defined as the lowest % improvement for TJC68, SJC66 and the median of 5 ACR components. These are • Patient's Assessment of Pain over previous 24 hours using a VAS; left end of line 0=no pain to right end of line 100=unbearable pain • Patient's Global Assessment of Disease Activity • Physician's Global Assessment of Disease Activity over previous 24 hours using a VAS where left end of line 0=no disease activity to right end of line 100=maximum disease activity • Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do • Acute-phase reactant: CRP. A positive % change indicates improvement. MMRM model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment and visit and previously failed medication and participant used as a random effect with an unstructured covariance structure.|Baseline and Week 12|Participants from the FAS, all participants in the safety analysis set who had at least 1 valid post-baseline assessment of DAS28-CRP in the double-blind period up to Week 12, with data available for analysis.|||percentage change||Standard Error|Least Squares Mean
2582365|NCT02379091|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR 50) and 70% (ACR70) Response at Weeks 12 and 24|"ACR20/50/70 response is defined as a ≥20/50/70% reduction from Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), and the following:~Patient's Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS); left end of the line 0=no pain to right end of the line 100=unbearable pain~Patient's Global Assessment of Disease Activity~Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity~Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do~Acute-phase reactant: C-reactive Protein (CRP)."|Baseline and Weeks 12 and 24|FAS includes all participants in the safety analysis set who had at least 1 valid post-baseline assessment of DAS28-CRP in the double-blind period up to Week 12. Number analyzed is the number of participants with data available for analysis at the given time point.|||percentage of participants|||Number
2582366|NCT02379091|Primary|Change From Baseline in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) at Week 12|The DAS28-CRP score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], general health: patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and acute phase response: C-Reactive Protein (CRP) for a total possible score of 0 (best) to approximately 10 (worst). Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicates improvement. A mixed model repeated measures (MMRM) model with main effects for study site, treatment, visit, and previously failed medication with interactions between visit and treatment, visit and previously failed medication, and visit and baseline value as a covariate and participant as a random effect with an unstructured covariance structure was used for analysis.|Baseline and Week 12|Participants from the Full Analysis Set (FAS), all participants in the safety analysis set who had at least 1 valid post-baseline assessment of DAS28-CRP in double-blind period up to Week 12, with data available at Baseline and Week 12 for analysis.|||score on a scale||Standard Error|Least Squares Mean
2582367|NCT02379052|Secondary|Percent of Participants With Treatment-Emergent Adverse Events (TEAEs) During the Study|Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that developed or worsened or became serious during the on-treatment period (time from the first dose of study drug up to the end of study (Week 28). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-participant hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline through Week 28|The safety analysis set (SAF) included all randomized participants who received any study drug, and were analyzed as treated.|||Percent of Participants|||Number
2582368|NCT02379052|Secondary|Percentage of Participants With Use of Rescue Medication or Procedure (e.g., Esophageal Dilation) Through Week 12||Baseline through Week 12|FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||Percent of Participants|||Number
2582369|NCT02379052|Secondary|Change From Baseline in Adult Eosinophilic Esophagitis Quality of Life Questionnaire (EoE-QOL-A) Score at Week 12|The EoE-QOL-A questionnaire includes 30 items related to 5 established domains (eating/diet impact, social impact, emotional impact, disease anxiety, and swallowing anxiety) of daily life experiences. The EoE-QOL-A has a 1-week recall period. The items are graded on a 5-point scale: 1 (Not at All), 2 (Slightly), 3 (Moderately), 4 (Quite a bit), and 5 (Extremely). The EoE-QOL-A score is the average obtained by dividing the total score by the number of questions (for participants without disease, 120/30 = 4). Total scores range from 1 to 5 (higher scores indicate worsening symptoms).|Baseline, Week 12|FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||Score on a Scale||Standard Error|Least Squares Mean
2582370|NCT02379052|Secondary|Absolute Change From Baseline in Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) by Feature at Week 12|The EoE-EREFS includes a total of 6 major items related to the presence/ severity of esophageal features. Specific features scored by the investigator include rings (absent[0], mild[1], moderate[2], severe[3], not applicable); stricture (yes[1], no[0], not applicable); diameter of the stricture (if applicable; measurement not scored); exudates (absent[0], mild [1], severe[2]); furrows (absent[0], present[1]); edema (absent[0], present[1]). The total score of the 5 scored items ranges from 0 to 8 (higher score indicates worsening symptoms).|Baseline, Week 12|FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||Score on a Scale||Standard Error|Least Squares Mean
2582371|NCT02379052|Secondary|Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophils of 3 Esophageal Regions at Week 12|Peak eosinophils/high power field (eos/hpf) was determined by counting eosinophils in the most inflamed areas of each esophageal region sampled at each time point and calculating the change in the peak count at each site.|Baseline, Week 12|FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||Percent Change||Standard Error|Least Squares Mean
2582372|NCT02379052|Secondary|Percentage of Participants Achieving ≥ 40% Improvement in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score From Baseline at Week 12|The EEsAI PRO questionnaire includes items related to the intensity and frequency of dysphagia, the influence of specific food groups on dysphagia symptoms, and other symptoms independent of eating or drinking (ie, heartburn, acid regurgitation, and chest pain). The total EEsAI PRO score ranges from 0 to 100 (higher score indicates worsening symptoms). The EEsAI PRO utilizes 24-hour and 1-week recall periods.|Baseline, Week 12|FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||Percentage of Participants|||Number
2582373|NCT02379052|Secondary|Percentage of Participants Achieving ≥ 40% Improvement in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score From Baseline at Week 10|The EEsAI PRO questionnaire includes items related to the intensity and frequency of dysphagia, the influence of specific food groups on dysphagia symptoms, and other symptoms independent of eating or drinking (ie, heartburn, acid regurgitation, and chest pain). The total EEsAI PRO score ranges from 0 to 100 (higher score indicates worsening symptoms). The EEsAI PRO utilizes 24-hour and 1-week recall periods.|Baseline, Week 10|FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||Percentage of Participants|||Number
2582374|NCT02379052|Secondary|Absolute Change From Baseline in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score at Week 12|The EEsAI PRO questionnaire includes items related to the intensity and frequency of dysphagia, the influence of specific food groups on dysphagia symptoms, and other symptoms independent of eating or drinking (ie, heartburn, acid regurgitation, and chest pain). The total EEsAI PRO score ranges from 0 to 100 (higher score indicates worsening symptoms). The EEsAI PRO utilizes 24-hour and 1-week recall periods.|Baseline, Week 12|FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||Score on a Scale||Standard Error|Least Squares Mean
2582375|NCT02379052|Secondary|Percent Change From Baseline in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score at Week 12|The EEsAI PRO questionnaire includes items related to the intensity and frequency of dysphagia, the influence of specific food groups on dysphagia symptoms, and other symptoms independent of eating or drinking (ie, heartburn, acid regurgitation, and chest pain). The total EEsAI PRO score ranges from 0 to 100 (higher score indicates worsening symptoms). The EEsAI PRO utilizes 24-hour and 1-week recall periods.|Baseline, Week 12|FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||Percent Change||Standard Error|Least Squares Mean
2582376|NCT02379052|Secondary|Absolute Change From Baseline in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score at Week 10|The EEsAI PRO questionnaire includes items related to the intensity and frequency of dysphagia, the influence of specific food groups on dysphagia symptoms, and other symptoms independent of eating or drinking (ie, heartburn, acid regurgitation, and chest pain). The total EEsAI PRO score ranges from 0 to 100 (higher score indicates worsening symptoms). The EEsAI PRO utilizes 24-hour and 1-week recall periods.|Baseline, Week 10|FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||Score on a Scale||Standard Error|Least Squares Mean
2582377|NCT02379052|Secondary|Percent Change From Baseline in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score at Week 10|The EEsAI PRO questionnaire includes items related to the intensity and frequency of dysphagia, the influence of specific food groups on dysphagia symptoms, and other symptoms independent of eating or drinking (ie, heartburn, acid regurgitation, and chest pain). The total EEsAI PRO score ranges from 0 to 100 (higher score indicates worsening symptoms). The EEsAI PRO utilizes 24-hour and 1-week recall periods.|Baseline, Week 10|FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||Percent Change||Standard Error|Least Squares Mean
2582378|NCT02379052|Secondary|Percentage of Participants Achieving a Reduction of ≥ 3 Points in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score From Baseline at Week 12|The SDI is a PRO used to determine frequency/ intensity of dysphagia (recall period 1-wk). Frequency of dysphagia events is graded on a 5-pt scale: 0=none, 1=1x/wk, 2=several/wk, 3=1x/day, 4=several/day; intensity is graded on a 6-pt scale: 0=swallowing unrestricted, 1=slight sensation of resistance, 2=slight retching with delay, 3=short period of obstruction necessitating intervention, 4=longer-lasting period of obstruction removable by vomiting, 5=long-lasting complete obstruction requiring endoscopic intervention. Total score ranges from 0-9 (higher score indicates worsening symptoms).|Baseline, Week 12|FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||Percentage of Participants|||Number
2583138|NCT02370121|Primary|Fasting Plasma Glucose (FPG)|The blood sample for determining of FPG, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.|week 12||||mmol/L||Standard Deviation|Mean
2582379|NCT02379052|Secondary|Percentage of Participants Achieving a Reduction of ≥ 3 Points in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score From Baseline at Week 10|The SDI is a PRO used to determine frequency/ intensity of dysphagia (recall period 1-wk). Frequency of dysphagia events is graded on a 5-pt scale: 0=none, 1=1x/wk, 2=several/wk, 3=1x/day, 4=several/day; intensity is graded on a 6-pt scale: 0=swallowing unrestricted, 1=slight sensation of resistance, 2=slight retching with delay, 3=short period of obstruction necessitating intervention, 4=longer-lasting period of obstruction removable by vomiting, 5=long-lasting complete obstruction requiring endoscopic intervention. Total score ranges from 0-9 (higher score indicates worsening symptoms).|Baseline, Week 10|FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||Percentage of Participants|||Number
2582380|NCT02379052|Secondary|Percent Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 12|The SDI is a PRO used to determine frequency/ intensity of dysphagia (recall period 1-wk). Frequency of dysphagia events is graded on a 5-pt scale: 0=none, 1=1x/wk, 2=several/wk, 3=1x/day, 4=several/day; intensity is graded on a 6-pt scale: 0=swallowing unrestricted, 1=slight sensation of resistance, 2=slight retching with delay, 3=short period of obstruction necessitating intervention, 4=longer-lasting period of obstruction removable by vomiting, 5=long-lasting complete obstruction requiring endoscopic intervention. Total score ranges from 0-9 (higher score indicates worsening symptoms).|Baseline, Week 12|FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||Percent Change||Standard Error|Least Squares Mean
2582381|NCT02379052|Secondary|Absolute Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 12|The SDI is a PRO used to determine frequency/intensity of dysphagia (recall period 1-wk). Frequency of dysphagia events is graded on a 5-pt scale: 0=none, 1=1x/wk, 2=several/wk, 3=1x/day, 4=several/day; intensity is graded on a 6-pt scale: 0=swallowing unrestricted, 1=slight sensation of resistance, 2=slight retching with delay, 3=short period of obstruction necessitating intervention, 4=longer-lasting period of obstruction removable by vomiting, 5=long-lasting complete obstruction requiring endoscopic intervention. Total score ranges from 0-9 (higher score indicates worsening symptoms).|Baseline, Week 12|FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||Score on a Scale||Standard Error|Least Squares Mean
2582382|NCT02379052|Secondary|Percent Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 10|The SDI is a PRO used to determine frequency/ intensity of dysphagia (recall period 1-wk). Frequency of dysphagia events is graded on a 5-pt scale: 0=none, 1=1x/wk, 2=several/wk, 3=1x/day, 4=several/day; intensity is graded on a 6-pt scale: 0=swallowing unrestricted, 1=slight sensation of resistance, 2=slight retching with delay, 3=short period of obstruction necessitating intervention, 4=longer-lasting period of obstruction removable by vomiting, 5=long-lasting complete obstruction requiring endoscopic intervention. Total score ranges from 0-9 (higher score indicates worsening symptoms).|Baseline, Week 10|Full analysis set (FAS) included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||Percent Change||Standard Error|Least Squares Mean
2582383|NCT02379052|Primary|Absolute Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 10|The SDI is a PRO used to determine frequency/ intensity of dysphagia (recall period 1-wk). Frequency of dysphagia events is graded on a 5-pt scale: 0=none, 1=1x/wk, 2=several/wk, 3=1x/day, 4=several/day; intensity is graded on a 6-pt scale: 0=swallowing unrestricted, 1=slight sensation of resistance, 2=slight retching with delay, 3=short period of obstruction necessitating intervention, 4=longer-lasting period of obstruction removable by vomiting, 5=long-lasting complete obstruction requiring endoscopic intervention. Total score ranges from 0-9 (higher score indicates worsening symptoms).|Baseline, Week 10|Full Analysis Set (FAS) included all randomized participants. Efficacy analyses were based on the treatment allocated by the interactive voice and web response system (IVRS/IWRS) at randomization (as randomized).|||Score on a Scale||Standard Error|Least Squares Mean
2582384|NCT02378961|Secondary|Percentage of Participants With Virologic Failure|"On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2582385|NCT02378961|Secondary|HCV RNA Change From Baseline||Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2582386|NCT02378961|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)|Participants in the Full Analysis Set with available data were analyzed|||percentage of participants||95% Confidence Interval|Number
2582387|NCT02378961|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2582388|NCT02378961|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 Weeks|Safety Analysis Set|||percentage of participants|||Number
2582389|NCT02378961|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.|Posttreatment Week 12|Full Analysis Set (FAS): participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2582460|NCT02378207|Primary|Percentage of Participants With Response Rates to TB Antigens as Compared to Baseline|Flow cytometry was used to examine TB Mb-specific CD4+ and CD8+ T-cell responses using the ICS assay. The antigens used to stimulate cells in this assay included peptide pools for the vaccine-matched proteins (Ag85B, ESAT-6, Rv2660c, and TB 10.4) as well as complex TB antigens (TB whole cell lysate [TB WCL], and BCG Pasteur strain.|Days 70 and 168||||percentage of participants||95% Confidence Interval|Number
2582390|NCT02378935|Secondary|Percentage of Participants With Virologic Failure|"On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2582391|NCT02378935|Secondary|HCV RNA Change From Baseline||Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)|Participants in the Full Analysis Set with available data were analyzed|||log10 IU/mL||Standard Deviation|Mean
2582392|NCT02378935|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable)|Participants in the Full Analysis Set with available data were analyzed|||percentage of participants||95% Confidence Interval|Number
2582393|NCT02378935|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2582394|NCT02378935|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 Weeks|Safety Analysis Set|||percentage of participants|||Number
2582395|NCT02378935|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.|Posttreatment Week 12|Full Analysis Set (FAS): participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2582396|NCT02378883|Secondary|Number of Participants With Migration of Retained Catheter Tip Post Embolization at 12 Months|Rate of migration of the retained catheter tip post embolization (long-term secondary endpoint)|12 months|Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter|||Participants|||Count of Participants
2582397|NCT02378883|Secondary|Number of Participants With Catheter-related Adverse Events at 12 Months|Number of participants with catheter-related adverse events at 12 months (long term secondary endpoint)|12 months|Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter|||Participants|||Count of Participants
2582398|NCT02378883|Secondary|Number of Participants With Catheter-related Adverse Events at 30 Days|Incidence of catheter-related adverse events at 30 days|30 days|Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter|||Participants|||Count of Participants
2582399|NCT02378883|Secondary|Number of Participants With Catheter/Tip Leakage From Detachment Zone at 30 Days|Rate of catheter/tip leakage from detachment zone|30 days|Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter|||Participants|||Count of Participants
2582400|NCT02378883|Secondary|Number of Participants With Migration of Retained Catheter Tip Post Embolization at 30 Days|Rate of migration of the retained catheter tip post embolization|30 days|Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter|||Participants|||Count of Participants
2582401|NCT02378883|Secondary|Number of Participants With Intentional Catheter Tip Detachment at 30 Days|Rate of intentional catheter tip detachment|30 days|Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter|||Participants|||Count of Participants
2582402|NCT02378883|Secondary|Number of Participants With Premature (Unintentional) Catheter Tip Detachment at 30 Days|Rate of premature (unintentional) catheter tip detachment|30 days|Participants treated with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter|||Participants|||Count of Participants
2582403|NCT02378883|Primary|Number of Participants With Catheter-related Adverse Events at 30 Days|"Premature (unintentional) catheter tip detachment with clinical sequelae~Catheter rupture/break/fracture with clinical sequelae~Retained catheter body in the vasculature"|30 days, after treatment with Onyx™ embolization using Apollo™ Onyx™ Delivery Microcatheter|The Apollo™ Onyx™ Delivery Microcatheter used for delivery of the Onyx™ Liquid Embolic System during brain AVM embolization procedures.|||Participants|||Count of Participants
2582404|NCT02378844|Secondary|Change in Headache Days in the Open Label Period|The mean change in number of headache days (as reported in the subject diary) during the open label period compared to the base-line run-in period|The 6 month open-label period compared to the four week run-in period|Randomized population (Intent to treat)|||Days||95% Confidence Interval|Mean
2582405|NCT02378844|Secondary|Number of Participants With Adverse Events|Adverse Effects were collected for all subjects for the duration of the study.|up to Week 36|Safety population|||Participants|||Count of Participants
2582406|NCT02378844|Secondary|Change in Migraine Days in the Open Label Period (Adjusted ANCOVA)|Change in number of migraine days (as reported in subject diary) during the 6 month open label period compared to the baseline run-in period.|The 6 month open-label period compared to the four week run-in period|Randomized population (Intent to treat)|||Days||Full Range|Mean
2582407|NCT02378844|Secondary|Compare Changes in Quality of Life EuroQol Questionnaire 5 Dimensions and 5 Levels (EQ-5D-5L)|"The descriptive system comprises five dimensions (5D): mobility, self-care, usual activities, pain/discomfort and anxiety/depression.~Each dimension has 5 levels (5L): no problems (1) , slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5).~Minimum score is 5 (no problems) and maximum score is 25 (extreme problems)~An overall health question is asked using a visual analogue scale(VAS) from 0-100 where 0 is bad health and 100 good health"|From four week run-in period to last four weeks in the randomization period|Randomized population, Intention to Treat (ITT) In the active group 24 subjects had missing data, in the sham group 35 subjects had missing data at the end of the randomized period|||scores on a scale||Full Range|Mean
2582461|NCT02378207|Primary|Number of Participants With Adverse Events|The number of solicited and unsolicited adverse events (AEs), including serious adverse events (SAEs), recorded post-vaccination for all participants.|Up to 8 months||||participants|||Number
2582462|NCT02378038|Secondary|Safety - Assessment of Adverse Events||2 months||||participants reporting at least 1 AE|||Number
2582463|NCT02378038|Secondary|Overall Survival||2 months|Analysis not performed as the study was terminated.||||||
2582408|NCT02378844|Secondary|Number of Participants According to Grade on the Migraine Disability Assessment (MIDAS) Before and After Randomized Period|"Migraine Disability Assessment (MIDAS) score from the end of run-in period to the end of randomized period. The MIDAS assessment measures the effect of headaches on a subject's daily functioning. It takes into account the past 3 months and is comprised of five questions. A lower score indicated less disability, a higher score indicates more disability. The scores are graded:~0-5, MIDAS Grade I, little disability 6-10, MIDAS Grade II, mild disability 11 to 20 MIDAS Grade III, moderate disability 21+ MIDAS Grade IV, severe disability"|3 months - end of run-in period to end of randomized period|"Randomized population, Intention to Treat (ITT) At randomisation (visit 2) subject numbers are 165 gammaCore-R and 167 gammaCore-R Sham.~At visit 6 the numbers are lower due to early subject discontinuation: 141 gammaCore-R and 132 gammaCore-R Sham"|||participants|||Number
2582409|NCT02378844|Secondary|Change in Headache Disability Using Headache Impact Test-6|Change in headache disability from the 4 week run-in period to the last 4 weeks of the randomized period as measured using the Headache Impact Test-6 (HIT-6). The HIT-6 measures the impact if a subject's headaches on their ability to function at work, at home and in social situations. Subjects are presented with 6 questions about ability to function and normal daily life and for each question they rate the impact of their headaches as 'never' (6 points) or 'rarely' (9 points) or 'sometimes' (10 points) or 'very often' (11 points) or 'always' (13 points). Minimum score = 36, maximum score = 78. A higher score indicates more impact.|From four week run-in period to last four weeks in the randomization period|Randomized population, Intention to Treat (ITT) In the active group 23 subjects had missing data, in the sham group 32 subjects had missing data at the end of the randomized period|||units on a scale||Full Range|Mean
2582410|NCT02378844|Secondary|Change in Number of Acute Medication Days|The mean change in number of acute medication days (as reported in the subject diary) from the run-in period to the last 4 weeks of the double-blind period|The last four weeks in the randomization period compared to the four week run-in period.|Randomized population, Intention to Treat (ITT)|||acute medication days||Standard Deviation|Mean
2582411|NCT02378844|Secondary|Mean Change in Number of Headache Days|The mean change in number of headache days (as reported in the subject diary) from the run-in period to the last 4 weeks of the double-blind period.|The last four weeks in the randomization period compared to the four week run-in period.|Randomized population, Intention to Treat (ITT)|||Days||Standard Deviation|Mean
2582412|NCT02378844|Secondary|Number of Participants With 50% Responder Rate|The number of subjects with a reduction of 50% or more in number of migraine days (as reported in the subject diary) from the run-in period to the last 4 weeks of the double-blind period.|The last four weeks in the randomization period compared to the four week run-in period.|Randomized population, Intention to Treat (ITT)|||Participants|||Count of Participants
2582413|NCT02378844|Primary|Change in the Number of Migraine Days|Change in number of migraine days (as reported in subject diary), comparing the 4 week run-in period to the last 4 weeks in the randomized period.|last 4 weeks of the randomized/controlled period compared to the subject's own 4-week run-in period.|Randomized population, Intention to Treat (ITT)|||Days||Standard Deviation|Mean
2582414|NCT02378753|Secondary|Number of Participants With Occurrence of Solicited and Unsolicited AEs During the 28 Days Following the Vaccination or Enrollment|Solicited local and systemic reactogenicity symptoms and unsolicited adverse events were assessed in safety sub-study participants (the first 449 participants enrolled at the COMAHS Library site), during the 28 days after vaccination (immediate group) or after enrollment without vaccination (deferred group).|During 28 days following vaccination||||Participants|||Count of Participants
2582415|NCT02378753|Secondary|Number of Participants With Occurrence of Solicited Injection-site and Systemic Reactogenicity Signs and Symptoms, Including Fever, on Vaccination Day and During the 7 Days Following the Vaccination or Enrollment.|Solicited symptoms were assessed only in safety sub-study participants (the first 449 participants enrolled at the COMAHS Library site), during the 7 days after vaccination (immediate group) or after enrollment without vaccination (deferred group). Participants were actively solicited for the occurrence of local (injection-site) pain, redness, and swelling and the following systemic reactogenicity symptoms: fever, joint pain, joint swelling, muscle pain, fatigue, feeling unwell, chills, headache, vomiting, nausea, diarrhea, abdominal pain, rash, oral ulcers, and skin vesicles (blisters).|Vaccination day and for 7 days following vaccination||||Participants|||Count of Participants
2582416|NCT02378753|Secondary|Suspected, Probable or Laboratory-confirmed Ebola|"Incidence of suspected, probable, or laboratory-confirmed Ebola, where suspected and probable cases are defined by the August 9, 2014 World Health Organization case definition recommendations for use during an Ebola outbreak, and laboratory-confirmed Ebola includes both study laboratory and non-study laboratory diagnostics. An Ebola Screening Form was required to be completed for all participants referred for evaluation of suspected Ebola; the Outcome Measure (Count of Participants) reflects the number of participants in each group for whom an Ebola Screening Form was completed."|6 months following vaccination||||Participants|||Count of Participants
2582417|NCT02378753|Secondary|Ebola Confirmed by Non-study or Study Diagnostics|Incidence of Ebola confirmed by the STRIVE study laboratory or by a non-study laboratory in each treatment group during the Randomized Portion of the trial. For the vaccine efficacy endpoint, all enrolled participants in both arms were followed for 18-24 weeks after enrollment (after which point participants in the deferred cohort received crossover vaccination). Statistical analysis was to proceed as survival analysis (time-to-event/time-to-infection) of cohort follow-up data during this period. There were no laboratory-confirmed cases of Ebola among study participants, so therefore no efficacy analyses were performed.|6 months following vaccination|The Overall Number of Participants Analyzed for this endpoint is the number of participants with suspected Ebola in each group who provided biological samples for testing, whether to the study laboratory or to a non-study laboratory.|||Participants|||Count of Participants
2582418|NCT02378753|Secondary|Death Due to Laboratory-confirmed Ebola|Deaths due to Ebola confirmed by the STRIVE study laboratory in each treatment group during the Randomized Portion of the trial. There were no laboratory-confirmed cases of Ebola among study participants, so therefore no efficacy analyses were performed.|6 months following vaccination||||Participants|||Count of Participants
2582464|NCT02378038|Secondary|Progression Free Survival||2 months|Analysis not performed as the study was terminated.||||||
2582465|NCT02378038|Secondary|Time to Response||2 months|Analysis not performed as there were no responders.||||||
2582419|NCT02378753|Primary|Number of Participants With Occurrence of Serious Adverse Events During the 6 Months Following the Vaccination|Number of Participants with Occurrence of SAEs within the 6-month follow-up period following a single dose of rVSVΔG-ZEBOV. Vaccination in the immediate group occurred within 7 days of enrollment if possible, and vaccination in the deferred-vaccination group occurred 18-24 weeks after enrollment.|6 months following vaccination|The Overall Number of Participants Analyzed for this endpoint is the number of participants in each group who provided any safety/AE data during 6-month (18- to 24-week) follow-up.|||Participants|||Count of Participants
2582420|NCT02378753|Primary|Laboratory-confirmed Ebola (Study Diagnostics)|"Incidence of Ebola confirmed by the STRIVE study laboratory in each treatment group during the Randomized Portion of the trial. For the vaccine efficacy endpoint, all enrolled participants in both arms were followed for 18-24 weeks after enrollment (after which point participants in the deferred cohort received crossover vaccination). Statistical analysis was to proceed as survival analysis (time-to-event/time-to-infection) of cohort follow-up data during this period.~There were no laboratory-confirmed cases of Ebola among study participants, so therefore no efficacy analyses were performed."|> 21 days following vaccination|The Overall Number of Participants Analyzed for this endpoint is the number of participants with suspected Ebola in each group who provided biological samples to the study laboratory for testing.|||Participants|||Count of Participants
2582421|NCT02378662|Primary|Patients Who Achieved Biological Activity of MDGN201 TARGTEPO Secretion as Measured by Serum Erythropoietin (EPO) Levels Above Baseline||52 weeks|No statistical analysis was performed as only two subjects were treated with MDGN201 TARGTEPO due to Sponsor's decision to discontinue study.|||Participants|||Count of Participants
2582422|NCT02378506|Primary|Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status: Throughout Study Treatment|Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.|Baseline up to Week 24|Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation.|||percentage of participants||95% Confidence Interval|Number
2582423|NCT02378506|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24|HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.|Baseline, Week 4, 12, 24|mITT population included all participants who had taken at least 1 dose of study medication. Here, “n” signifies number of participants who were evaluable for specified time points.|||units on a scale||Standard Deviation|Mean
2582424|NCT02378506|Secondary|Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24|DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from the number of swollen joints and tender joints using the 28 joints count, C-Reactive protein (milligram per liter [mg/L]) and participant's general health visual analog scale assessment (scores ranging 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (CRP) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity.|Baseline, Week 4, 12, 24|mITT population included all participants who had taken at least 1 dose of study medication. Here, “n” signifies number of participants who were evaluable for specified time points.|||units on a scale||Standard Deviation|Mean
2582425|NCT02378506|Secondary|Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24|DAS28: measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, erythrocyte sedimentation rate (millimeter per hour [mm/hour]) and participant's general health visual analog scale assessment (scores: 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (ESR) score: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (ESR) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity.|Baseline, Week 4, 12, 24|mITT population included all participants who had taken at least 1 dose of study medication. Here, “n” signifies number of participants who were evaluable for specified time points.|||units on a scale||Standard Deviation|Mean
2582426|NCT02378506|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 responder: participants with 70% improvement in tender and swollen 28-joint counts and 70% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR70 response were reported.|Week 4, 12, 24|mITT population included all participants who had taken at least 1 dose of study medication. Here, “n” signifies number of participants who were evaluable for specified time points.|||percentage of participants||95% Confidence Interval|Number
2582466|NCT02378038|Secondary|Duration of Overall Response||2 months|Analysis not performed as there were no responders.||||||
2582467|NCT02378038|Secondary|Disease Control Rate|Proportion of subjects with stable disease or better (CR/CMR, PR/PMR or SD/NMR)|2 months||||Participants|||Count of Participants
2582468|NCT02378038|Primary|Overall Response Rate|Proportion of subjects with complete response (CR/CMR) or partial response (PR/PMR)|2 months||||Participants|||Count of Participants
2582427|NCT02378506|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 responder: participants with 50% improvement in tender and swollen 28-joint counts and 50% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR50 response were reported.|Week 4, 12, 24|mITT population included all participants who had taken at least 1 dose of study medication. Here, “n” signifies number of participants who were evaluable for specified time points.|||percentage of participants||95% Confidence Interval|Number
2582428|NCT02378506|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 responder: participants with 20 percent (%) improvement in tender and swollen 28-joint counts and 20% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR20 response were reported.|Week 4, 12, 24|Modified intent-to-treat (mITT) population included all participants who had taken at least 1 dose of study medication. Here, “n” signifies number of participants who were evaluable for specified time points.|||percentage of participants||95% Confidence Interval|Number
2582429|NCT02378506|Secondary|Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities|Laboratory abnormalities(national cancer institute toxicity criteria version 4.0),Grade 3:neutrophil (greater than or equal to[>=]0.5,less than[<]1.0 10^9/L),lymphocyte (<0.5 10^9/L),hemoglobin (Hb) (<80,>=65 gram per liter [g/L]),platelet(<50.0,>=25.0 10^9/L),white blood count(WBC) (<2.0, >=1.0 10^9/L);alkaline phosphatase (AP),aspartate aminotransferase(AST),alanine aminotransferase(ALT) (greater than[>]5.0*upper range [UR], <=20.0*UR unit per liter[U/L]);bilirubin(>1.5*UR, less than or equal to[<=]3.0*UR micromole per liter[mcmol/L]);creatinine(>3.0*UR, <=6.0*UR mcmol/L);albumin (<20.0 g/L),urea(>3.0*UR, <=4.0*UR g/L);potassium (K)-high,low (>6.0,<=7.0or<3.0,>=2.5 mcmol/L); sodium(Na)-high,low(>155, <=160 or <130, >=120 mcmol/L)and Grade 4: neutrophil(<0.5 10^9/L),Hb (<65 g/L);platelet (<25.0 10^9/L); WBC(<1.0 10^9/L);AP,AST,ALT(>20.0*UR U/L);bilirubin(>3.0*UR mcmol/L);creatinine (>6.0*UR mcmol/L);urea (>4.0*UR g/L);K-high,low (>7.0or<2.5 mcmol/L);Na-high, low (>160or<120 mcmol/L).|Baseline (Day 1) up to Week 28 (Follow-up)|Safety population included all participants who had taken at least 1 dose of study medication.|||participants|||Number
2582430|NCT02378506|Secondary|Number of Participants With Injection Site Reactions|Injection site reactions included injection site erythema, swelling, pain and warmth.|Baseline (Day 1) up to Week 28 (Follow-up)|Safety population included all participants who had taken at least 1 dose of study medication.|||participants|||Number
2582431|NCT02378506|Secondary|Number of Participants With Investigator-Identified Serious Infections|Infection was considered as serious by investigator for any of the following outcomes: death; life-threatening; required initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity or congenital anomaly/birth defect.|Baseline (Day 1) up to Week 28 (Follow-up)|Safety population included all participants who had taken at least 1 dose of study medication.|||participants|||Number
2582432|NCT02378506|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to Week 28 (Follow-up)|Safety population included all participants who had taken at least 1 dose of study medication.|||participants|||Number
2582433|NCT02378506|Secondary|Percentage of Participants With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment|Percentage of participants with positive Etanercept neutralizing anti-drug antibodies were summarized.|Baseline (Day 1) up to Week 24|Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation.|||percentage of participants||95% Confidence Interval|Number
2582434|NCT02378506|Primary|Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status at Week 24|Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.|Week 24|"Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation. Here, N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
2582435|NCT02378506|Primary|Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12|Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.|Week 12|"Analysis set included all participants who had taken at least 1 dose of study medication and had at least 1 Etanercept anti-drug antibody evaluation. Here, Number of Participants Analyzed (N) signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
2588897|NCT02299934|Primary|The Visibility of the Variations of the Liver Blood Supply||Day 1|Study was terminated prior to collecting any outcome measure data.||||||
2582436|NCT02378480|Secondary|Number of Participants With the Indicated Type of Adverse Event (AE)|An AE is defined as any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given a test article or in a clinical study. The event does not need to be causally related to the test article or clinical study. A serious adverse event (SAE) is defined as an event that resulted in death, was life-threatening, required hospitalization or prolongation of an existing hospitalization, resulted in a persistent or significant disability or incapacity, resulted in cancer, or resulted in a congenital anomaly or birth defect. A treatment-emergent AE (TEAE) is defined as any AE that newly appeared, increased in frequency, or worsened in severity on or after the initiation of active test article. Vital sign measurements, electrocardiogram findings, and laboratory values classified as adverse events were included in the analysis. Data are presented as the number of participants with at least 1 of the event.|0 to 37 days|Safety Population: all randomized participants who received test article|||Participants|||Count of Participants
2582437|NCT02378480|Secondary|Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population|At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the infection was sufficiently resolved such that further antibacterial therapy was not needed. These participants may have had some residual changes related to infection requiring ancillary treatment. Clinical Failure was defined as meeting any of the following criteria: infection required additional treatment with alternative antibacterial therapy; participant received antibacterial therapy between the EOT Visit and the PTE Visit that may have been effective for the infection under study for a different infection from the one under study; unplanned major surgical intervention for the infection under study between the EOT and PTE Visits; participant died before evaluation.|Screening; 7 to 14 days after the last day of therapy|CE-PTE Population: all participants in the mITT Population meeting additional pre-defined criteria|||Participants|||Count of Participants
2582438|NCT02378480|Secondary|Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit|At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the infection was sufficiently resolved such that further antibacterial therapy was not needed. These participants may have had some residual changes related to infection requiring ancillary treatment. Clinical Failure was defined as meeting any of the following criteria: infection required additional treatment with alternative antibacterial therapy; participant received antibacterial therapy between the End-of-Treatment (EOT) Visit and the PTE Visit that may have been effective for the infection under study for a different infection from the one under study; unplanned major surgical intervention for the infection under study between the EOT and PTE Visits; participant died before evaluation. Indeterminate: clinical response to test article could not be adequately inferred.|Screening; 7 to 14 days after the last day of therapy|mITT Population|||Participants|||Count of Participants
2582439|NCT02378480|Primary|Number of Participants With Early Clinical Response|Early clinical response is defined as clinical success, which is categorized as survival with at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to Screening measurements, without receiving any rescue antibacterial therapy. An indeterminate classification is used for a response that could not be adequately inferred because the participant was not assessed because they withdrew consent, were lost to follow-up, or other specified reason.|Screening; 48 to 72 hours after the first dose of test article|Modified Intent-to-Treat (mITT) Population: all randomized participants without a baseline sole Gram-negative ABSSSI pathogen|||Participants|||Count of Participants
2582440|NCT02378402|Primary|Myocaridal Lipid on MRS|We quantified the total myocardial TG resonance as well as its components including FA (lipid resonances δ 0.9, 1.3 and 1.6 ppm) and UFA (lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) from water-suppressed spectra. We also determined the water resonance (~ δ 4.7 ppm) from spectra without water suppression. Myocardial TG content relative to water as well as relative amounts of myocardial TG was calculated from the available data.|12 month||||ratios||Standard Deviation|Mean
2582441|NCT02378220|Secondary|Number of Clinician-accepted of Recommendations as Measured by Tabulation|To assess the proportion of study pharmacist recommendations acted on by clinicians.|60 days|"This secondary outcome assessed the proportion of YouScript® Personalized Prescribing System recommendations provided for patients in the tested group acted on by clinicians."|||recommendations|||Number
2582442|NCT02378220|Secondary|Number of Pharmacist-accepted of Recommendations as Measured by Tabulation|To assess the proportion of YouScript® Personalized Prescribing System recommendations accepted by the study pharmacist and passed on to clinicians.|60 days|"This secondary outcome assessed the proportion of YouScript® Personalized Prescribing System recommendations provided for patients in the tested group accepted by the study pharmacist and passed to clinicians."|||recommendations|||Number
2582443|NCT02378220|Secondary|Number of Falls as Measured by Tabulation|To assess whether YouScript® testing decreases falls|60 days||||Falls||Full Range|Mean
2582444|NCT02378220|Secondary|Activities of Daily Living as Measured by OASIS Scale|We assessed the impact of genetic testing on the frequency of activities of daily living (ADL) and instrumental activities of daily living (IADL) assistance according to OASIS M2110 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M2110, one data point in the OASIS system, measures frequency of receiving ADL/IADL assistance on a scale of 0 to 5, with a lower score indicating less frequent assistance.|30 days, 60 days post discharge|The secondary outcomes assessed frequency of ADL and IADL according to OASIS M2110 of the tested group and the untested group at 30 and 60 days post-discharge.|||Scores on a scale||Full Range|Mean
2582445|NCT02378220|Secondary|Disruptive Behavior as Measured by OASIS Scale|We assessed the impact of genetic testing on frequency of disruptive behavior according to OASIS M1745 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1745, one data point in the OASIS system, measures frequency of disruptive behavior by patient on a scale of 0 to 5, with a lower score indicating less frequent disruptive behavior.|30 days, 60 days post discharge|The secondary outcomes assessed frequency of disruptive behavior according to OASIS M1745 of the tested group and the untested group at 30 and 60 days post-discharge.|||Scores on a scale||Full Range|Mean
2582446|NCT02378220|Secondary|Depression as Measured by Patient Health Questionnaire (PHQ)-2 Scale|We assessed the impact of genetic testing on frequency of depressive mood according to PHQ-2 at 30 and 60 days post discharge. PHQ-2 evaluates patient depression by assessing two factors: frequency of little interest or pleasure in doing things and frequency of feeling down, depressed, or hopeless. This outcome measure assessed the second factor, frequency of feeling down or depressed. The scale for this factor ranges from 0 to 3, with a lower score represented less frequent depressive feelings.|30 days, 60 days post discharge|The secondary outcomes assessed feelings of depression according to PHQ-2 of the tested group and the untested group at 30 and 60 days post-discharge.|||Scores on a scale||Full Range|Mean
2582447|NCT02378220|Secondary|Anxiety as Measured by OASIS Scale|We assessed the impact of genetic testing on frequency of anxiety according to OASIS M1720 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1720, one data point in the OASIS system, measures patient confusion frequency on a scale of 0 to 3, with a lower score indicating less frequent confusion.|30 days, 60 days post discharge|The secondary outcomes assessed frequency of anxiety according to OASIS M1720 of the tested group and the untested group at 30 and 60 days post-discharge.|||Scores on a scale||Full Range|Mean
2582448|NCT02378220|Secondary|Confusion as Measured by OASIS Scale|We assessed the impact of genetic testing on frequency of confusion according to OASIS M1710 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1710, one data point in the OASIS system, measures patient confusion frequency on a scale of 0 to 4, with a lower score indicating less frequent confusion.|30 days, 60 days post discharge|The secondary outcomes assessed frequency of confusion according to OASIS M1710 of the tested group and the untested group at 30 and 60 days post-discharge.|||Scores on a scale||Full Range|Mean
2582449|NCT02378220|Secondary|Pain as Measured by OASIS Scale|We assessed the impact of genetic testing on patient pain frequency according to OASIS M1242 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1242, one data point in the OASIS system, measures patient pain frequency on a scale of 0 to 4, with a lower score indicating less frequent pain.|30 days, 60 days post discharge|The secondary outcomes assessed frequency of pain according to OASIS M1242 of the tested group and the untested group at 30 and 60 days post-discharge.|||Scores on a scale||Full Range|Mean
2582450|NCT02378220|Secondary|Overall Status as Measured by Outcome and Assessment Information Set (OASIS) Scale|We assessed the impact of genetic testing on overall status according to OASIS M1034 at 30 and 60 days post discharge. OASIS measures various data items to assess home health care quality and performance. OASIS M1034, one data point in the OASIS system, measures overall patient status on a scale of 0 to 3, with a lower score indicating better overall status.|30 days, 60 days post discharge|The secondary outcomes assessed the overall status according to OASIS M1034 of the tested group and the untested group at 30 and 60 days post-discharge.|||Scores on a scale||Full Range|Mean
2582451|NCT02378220|Secondary|Time to 1st Emergency Department Visit|To assess time to first emergency department visit, we compared the exploratory time-to-event outcomes (time to 1st ED visit) between the tested and untested groups at 30 days and 60 days. These outcomes were measured using cumulative percentage events at 30 and 60 days, referring to the percentage of subjects who visited the emergency department before or at 30 and 60 days.|30 days, 60 days|Compared the exploratory time-to-event outcomes between the tested and untested groups at 30 days and 60 days.|||Percentage of participants|||Number
2582452|NCT02378220|Secondary|Time to 1st Re-hospitalization|To assess time to first re-hospitalization, we compared the exploratory time-to-event outcomes between the tested and untested groups at 30 days and 60 days. These outcomes were measured using cumulative percentage events at 30 and 60 days, referring to the percentage of subjects re-hospitalized before or at 30 and 60 days.|30 days, 60 days|We compared the exploratory time-to-event outcomes between the tested and untested groups at 30 days and 60 days.|||Percentage of participants|||Number
2582453|NCT02378220|Primary|The Primary Outcomes Included the Number of Emergency Department Visits at 30 and 60 Days.|Assessed the number of Emergency Department visits at 30 and 60 days post discharge with pharmacogenetic testing and YouScript® Personalized Prescribing system.|30 days, 60 days post discharge|The primary outcomes assessed the number of emergency department visits between the tested group and the untested group at 30 and 60 days post-discharge.|||ED visits||Full Range|Mean
2582454|NCT02378220|Primary|Number of Re-hospitalizations at 30 and 60 Days|The primary outcomes included the number of re-hospitalizations at 30 and 60 days.|30 days, 60 days post discharge|Primary outcomes included the number of re-hospitalizations between the tested group and the untested group at 30 and 60 days post-discharge.|||Re-hospitalizations||Full Range|Mean
2582455|NCT02378207|Secondary|Evaluate QFT-GIT and ESAT-6 Free IGRA Discordance and Conversion/Reversion Rate During the Course of the Trial.|"Magnitude and positivity of interferon (IFN)-γ release using QFT-GIT ELISA in QFT-GIT tests.~Magnitude and positivity of IFN-γ release using QFT-GIT ELISA in ESAT-6 free IGRAs."|Up to day 168|||||||
2582456|NCT02378207|Secondary|Measure Non-classical Major Histocompatibility Complex (MHC)-Restricted T-cell Vaccine-induced Responses, Such as to Mycobacterial Lipids (CD1-restricted) and Metabolites (MR1-restricted).|"Frequency of CD4+, CD8+, and CD4/CD8 double-negative T-cell responses restricted by CD1 (recognizing specific Mtb lipids) before and after BCG revaccination in Group 3 participants.~Frequency of mucosal-associated invariant T-cells (MAIT) restricted by MR1 (recognizing vitamin B metabolites) before and after BCG revaccination in Group 3 participants"|Up to day 168|||||||
2582457|NCT02378207|Secondary|Evaluate Changes in Innate Cells in Response to the Vaccine Regimens|Blood concentrations of innate immune cell populations including lymphocyte populations, dendritic cells, monocytes, and granulocytes before and after vaccination|Up to day 168|||||||
2582458|NCT02378207|Secondary|* Evaluate Immune Response From Vaccine Regimens by Measuring Early (Innate) Vaccine-induced Peripheral Blood Transcription Profiles; Determine Which Responses Are Associated With Antigen-specific Adaptive Responses * Evaluate Adaptive Immune Response.|"Changes in gene expression measured in longitudinally-collected blood samples relative to samples collected at baseline. The transcriptional profiles will be correlated with antigen-specific adaptive responses measured in Primary objective 2.~Transcriptional analysis of antigen-stimulated peripheral blood mononuclear cells (PBMC) at 2 weeks post vaccination will be performed.."|Up to day 168|||||||
2588898|NCT02299934|Primary|Liver Blood Supply Diameters||Day 1|Study was terminated prior to collecting any outcome measure data.||||||
2582469|NCT02377986|Primary|Clutter Image Rating Scale|"Three sets of photographs, each containing nine photos of a single room with varying levels of clutter. A selection is made as to which photograph best resembles their own home.~This scale assesses the clutter levels in the bedroom, living room and kitchen. The scale for each room ranges from 1 to 9. Clutter that reaches the level 4 indicates significant difficulty with clutter that affects the person's life."|Change from baseline at 0, 12 weeks and 18 weeks after treatment start||||units on a scale||Full Range|Median
2582470|NCT02377986|Primary|Savings Inventory Revised|"The Saving Inventory-Revised scale (SI-R) is a 23-item questionnaire with 3 factor-analytically defined sub-scales for difficulty discarding, excessive clutter, and compulsive acquisition.~The total score (sum of 23 items) ranges from 0 to 92. Total score higher than 41 shows significant difficulty with clutter.~For the acquisition subscale we sum items 2 (reverse score), 9, 11, 14, 16, 18 and 21. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with excessive acquisition.~For the difficulty discarding subscale we sum items 4(reverse score), 6, 7, 13, 17, 19, 23. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with discarding.~For the clutter subscale we sum items 1, 3, 5, 8, 10, 12, 15, 20, 22. The subscale ranges from 0 to 36 and score greater than 15 indicates difficulty with accumulated clutter."|Change from baseline at 0, 12 weeks and 18 weeks after treatment start||||units on a scale||Full Range|Median
2582471|NCT02377947|Other Pre-specified|Duration of Hospital Stay||upto 30 days of hospital admission||||hours||Standard Deviation|Mean
2582472|NCT02377947|Other Pre-specified|Reduction in Blood Ammonia Level|"Change from baseline was calculated at the end of treatment by using following formula wherever applicable:~Change from baseline = Blood ammonia level at the end of treatment - Blood ammonia level at baseline"|reported at 48 hrs|The ammonia levels were available at baseline for 28 patients where as the last observed blood ammonia level after administration of lactulose enema was available for 4 patients. Thus the change from baseline was calculated for 4 patients. The Change value = Visit value - Baseline Value|||Mcg/DL||Standard Deviation|Mean
2582473|NCT02377947|Other Pre-specified|Safety of Lactulose Retention Enema (Number of Adverse Drug Reactions & Complications).|Safety of Lactulose retention enema (number of adverse drug reactions & complications). Complications pertinent to lactulose retention enema are in reference to potential adverse effects associated with the use of rectal device associated with the application of the lactulose retention enema kit.|Chart Review of Events over 48 Hour Period||||number of events|||Number
2582474|NCT02377947|Secondary|Mortality|Mortality in patients treated with lactulose retention enema|within 48 hrs||||Participants|||Count of Participants
2582475|NCT02377947|Secondary|Time to Complete Reversal|Time to complete reversal of deep-grade (Grade 3 and 4 West-Haven Criteria) HE after administration of lactulose retention enema|up to 48 hrs||||Hours||Standard Deviation|Mean
2582476|NCT02377947|Secondary|Hepatic Encephalopathy (HE) Grade Shift at 24 and 48 Hours|"Grade shift at 24 and 48 hours - from baseline to 24 and 48 hours post administration of lactulose retention enema.~Complete reversal of deep grade HE is defined as subjects having HE grade=<grade 2 as per West-Haven criteria where grade 0 is Normal, Grade 1 is Mild lack of awareness, Grade 2 is Lethargic, Grade 3 is Somnolent but arousable and Grade 4 is Coma"|HE Grade shift at 24 hrs and HE Grade shift at 48 hrs||||percentage of participants|||Number
2582477|NCT02377947|Primary|Complete Reversal|Percentage of patients with complete reversal of deep-grade (Grade 3 and 4 West-Haven Criteria) Hepatic Encephalopathy after administration of lactulose retention enema|48 hrs||||percentage of participants||95% Confidence Interval|Number
2582478|NCT02377947|Primary|Complete Reversal|Percentage of patients with complete reversal of deep-grade (Grade 3 and 4 West-Haven Criteria) Hepatic Encephalopathy after administration of lactulose retention enema|24 hrs||||percentage of participants||95% Confidence Interval|Number
2582479|NCT02377921|Secondary|Change From Baseline in GNEM FAS Upper Extremity Domain Score at Week 48|Upper extremity use and function was assessed using the Mobility domain of the GNEM-FAS instrument a disease-specific measure developed to assess the functional impact of changes in muscle strength on mobility (reflective of the upper extremities). This mobility score ranges from 0 to 40 with higher scores representing greater mobility.|Baseline, Week 48|Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.|||units on a scale||95% Confidence Interval|Least Squares Mean
2582480|NCT02377921|Secondary|Change From Baseline in Percent Predicted Meters Walked in the 6MWT at Week 48|The total distance walked (meters) in a 6-minute period was measured, and the percent predicted distance based on normative data for age and gender was estimated.|Baseline, Week 48|Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.|||percentage of predicted meters||95% Confidence Interval|Least Squares Mean
2582481|NCT02377921|Secondary|Change From Baseline in Meters Walked in the 6MWT at Week 48|The total distance walked (meters) in a 6-minute period was measured.|Baseline, Week 48|Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.|||meters||95% Confidence Interval|Least Squares Mean
2582482|NCT02377921|Secondary|Change From Baseline in Number of Stands in the Sit to Stand Test at Week 48|Lower extremity function was assessed using a sit-to-stand test. The number of times the participant can rise from a seated to a standing position in a 30-second period was recorded.|Baseline, Week 48|Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.|||stands||95% Confidence Interval|Least Squares Mean
2582483|NCT02377921|Secondary|Change From Baseline in Number of Lifts in the 30 Second Weighted Arm Lift Test at Week 48|Upper extremity function was assessed using a weighted arm lift test performed bilaterally. The number of times the participant can raise a 1 kg weight above the head in a 30-second period was recorded.|Baseline, Week 48|Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.|||arm lifts||95% Confidence Interval|Least Squares Mean
2582484|NCT02377921|Secondary|Change From Baseline in GNEM FAS Mobility Domain Score at Week 48|Lower extremity use and function was assessed using the Mobility domain of the GNEM-FAS instrument a disease-specific measure developed to assess the functional impact of changes in muscle strength on mobility (reflective of the lower extremities). This mobility score ranges from 0 to 40 with higher scores representing greater mobility.|Baseline, Week 48|Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.|||units on a scale||95% Confidence Interval|Least Squares Mean
2582485|NCT02377921|Secondary|Change From Baseline in LEC Score (Total Force in kg) at Week 48|Muscle strength based on MVIC against a dynamometer was measured bilaterally in the following lower extremity muscle groups: knee flexors, hip flexors, hip extensors, hip abductors and hip adductors. The LEC is derived from the sum of the average of the right and left total force values (measured in kg).|Baseline, Week 48|Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.|||kg||95% Confidence Interval|Least Squares Mean
2582486|NCT02377921|Secondary|Change From Baseline in Muscle Strength in the Knee Extensors at Week 48|Lower extremity muscle strength in the knee extensors was measured by dynamometry. Bilateral total force was defined as the average of the right and left force values (measured in kg).|Baseline, Week 48|Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.|||kg||95% Confidence Interval|Least Squares Mean
2582487|NCT02377921|Primary|Change From Baseline in UEC Score (Total Force in kg) at Week 48|Muscle strength based on the maximum voluntary isometric contraction (MVIC) against a dynamometer was measured bilaterally in the following upper extremity muscle groups: gross grip, shoulder abductors, elbow flexors, and elbow extensors. The UEC is derived from the sum of the average of the right and left total force values (measured in kg).|Baseline, Week 48|Primary Analysis Set: participants who had a Baseline and at least 1 postbaseline measurement.|||kg||95% Confidence Interval|Least Squares Mean
2582488|NCT02377817|Secondary|Percentage of Total Sleep Time in Each Position|To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the percentage (%) of total sleep time in each position (left, supine, right, prone) per the participant's self report and is compared with the percentage (%) of total sleep time in each position (left, supine, right, prone) per the polysomnography data.|1 night (approximately 8 hours)|Of 18 participants that answered this question, all except 1 of these participants answered it on both nights, which yields 35 nights (35 self-reports and 35 polysomnography reports). The Arms/Groups are combined in this analysis because the treatment order was not expected to affect the accuracy of self-reporting.|||percentage of sleep time (%)|Nights|Standard Deviation|Mean
2582489|NCT02377817|Secondary|Number of Position Changes|To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the number of times the participant changed body position (e.g., supine to left side) per the participant's self report and is compared with the number of times the participant changed body position per the polysomnography data.|1 night (approximately 8 hours)|Only 15 participants completed this question; each of these spent 2 nights in the sleep lab (1 PrenaBelt night and 1 sham PrenaBelt night), which is 30 nights (30 self-reports and 30 polysomnography reports). The Arms/Groups are combined in this analysis because the treatment order was not expected to affect the accuracy of self-reporting.|||position changes|Nights|Inter-Quartile Range|Median
2582490|NCT02377817|Secondary|Waking Position|To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the participant's waking position (left, supine, right, prone) per the participant's self report and is compared with the waking position (left, supine, right, prone) per the polysomnography data.|1 night (approximately 8 hours)|20 participants completed the study and each spent 2 nights in the sleep lab (1 night wearing the PrenaBelt and 1 night wearing the sham PrenaBelt), which is 40 nights (40 self-reports and 40 polysomnography reports). The Arms/Groups are combined in this analysis because the treatment order was not expected to affect the accuracy of self-reporting.|||Nights|Nights||Count of Units
2582491|NCT02377817|Secondary|Sleep Onset Position|To determine the accuracy of self-reported sleep behaviours against the gold-standard, polysomnography. This is the sleep onset position (left, supine, right) per the participant's self report and is compared with the sleep onset position (left, supine, right) per the polysomnography data.|1 night (approximately 8 hours)|20 participants completed the study and each spent 2 nights in the sleep lab (1 night wearing the PrenaBelt and 1 night wearing the sham PrenaBelt), which is 40 nights (40 self-reports and 40 polysomnography reports). The Arms/Groups are combined in this analysis because the treatment order was not expected to affect the accuracy of self-reporting.|||Nights|Nights||Count of Units
2582492|NCT02377817|Secondary|PrenaBelt User Feedback Questionnaire - Intention to Use|"Each participant will complete the PrenaBelt User Feedback Questionnaire. On a scale of 1 to 10, participant's intention to use the PrenaBelt during a subsequent pregnancy if it was available to her.~Note:~1 = participant would never use it again 5-6 = participant would consider using it again 10 = participant would certainly use it again"|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||units on a scale||Inter-Quartile Range|Median
2582493|NCT02377817|Secondary|PrenaBelt User Feedback Questionnaire - Comfort|"Each participant will complete the PrenaBelt User Feedback Questionnaire. On a scale of 1 to 10, participant's level of comfort while wearing and sleeping with the PrenaBelt. Note:~1 = extremely uncomfortable 5-6 = acceptable 10 = extremely comfortable"|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||units on a scale||Inter-Quartile Range|Median
2582494|NCT02377817|Secondary|PrenaBelt User Feedback Questionnaire - Satisfaction|"Each participant will complete the PrenaBelt User Feedback Questionnaire.~On a scale of 1 to 10, participant's level of satisfaction with the PrenaBelt. Note:~1 = extremely dissatisfied 5-6 = acceptable 10 = extremely satisfied"|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||units on a scale||Inter-Quartile Range|Median
2582495|NCT02377817|Secondary|Number of Participants With Snoring|This is a standard polysomnography measure of the presence of snoring via nasal cannula (pressure transducer) and by objective report of the research assistant (real-time audio feed).|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||Participants|||Count of Participants
2582496|NCT02377817|Secondary|Peripheral Blood Oxygen Saturation (SpO2)|SpO2 measured by fingertip pulse oximetry is a standard measure to indicate the oxygen saturation. Mean SpO2, Min SpO2, and Max SpO2 during Rapid Eye Movement (REM), and Non-REM (NREM) states.|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||percentage of SpO2 (%)||Inter-Quartile Range|Median
2582497|NCT02377817|Secondary|Respiratory Disturbance Index (RDI)|This is a standard polysomnography measure. Like the AHI, RDI reports on respiratory events during sleep, but unlike the AHI, it also includes respiratory-effort related arousals (RERAs). RERAs are arousals from sleep that do not technically meet the definitions of apneas or hypopneas, but do disrupt sleep. Will be reported as a total RDI as well as RDI while supine and RDI while non-supine.|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||events per hour||Inter-Quartile Range|Median
2582498|NCT02377817|Secondary|Respiratory Effort-Related Arousal Index|Respiratory Effort-Related Arousal (RERA) index is a standard polysomnography measure to indicate arousals from respiratory effort. Will be reported in units of 'arousals per hour'.|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||arousals per hour||Inter-Quartile Range|Median
2582499|NCT02377817|Secondary|Apnea Hypopnea Index|Apnea hypopnea index (AHI) is a standard polysomnography measure to indicate the severity of sleep apnea. AHI is the average number of apnea and hypopnea events per hour. Will be reported as a total AHI in units of 'events per hour'.|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||events per hour||Inter-Quartile Range|Median
2582500|NCT02377817|Secondary|Percent REM Sleep|Percent (%) of total sleep time in rapid eye movement (REM) sleep|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||percentage of sleep time (%)||Standard Deviation|Mean
2582501|NCT02377817|Secondary|Percent Stage 3 Sleep|Percent (%) of total sleep time in sleep stage 3.|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||percentage of sleep time (%)||Standard Deviation|Mean
2582502|NCT02377817|Secondary|Percent Stage 2 Sleep|Percent (%) of total sleep time in sleep stage 2.|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||percentage of sleep time (%)||Standard Deviation|Mean
2582503|NCT02377817|Secondary|Percent Stage 1 Sleep|Percent (%) of total sleep time in sleep stage 1.|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||percentage of sleep time (%)||Standard Deviation|Mean
2582504|NCT02377817|Secondary|Respiratory Arousal Index|This is a standard polysomnography measure of the number of times the participant was aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness due to respiratory events. This is reported as an 'arousal index', which is an average of the number of arousals per hour.|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||arousals per hour||Inter-Quartile Range|Median
2582505|NCT02377817|Secondary|Periodic Limb Movement Arousal Index|This is a standard polysomnography measure of the number of times the participant was aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness due to periodic limb movements (PLMs). This is reported as an 'arousal index', which is an average of the number of arousals per hour.|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||arousals per hour||Inter-Quartile Range|Median
2582506|NCT02377817|Secondary|Spontaneous Arousal Index|This is a standard polysomnography measure of the number of times the participant was spontaneously aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness. This is reported as an 'arousal index', which is an average of the number of arousals per hour.|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||arousals per hour||Standard Deviation|Mean
2582507|NCT02377817|Secondary|Total Arousal Index|This is a standard polysomnography measure of the number of times the participant was aroused from a deeper stage of NREM sleep to a lighter stage, or from REM sleep toward wakefulness. This is reported as a 'total arousal index', which is an average of the number of arousals per hour, and is further classified as a spontaneous, periodic leg movement, or respiratory arousal index.|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||arousals per hour||Inter-Quartile Range|Median
2582508|NCT02377817|Secondary|Sleep Efficiency|This is a standard polysomnography measure of the percentage (%) of time the participant was asleep during the sleep test.|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||percentage of sleep time (%)||Inter-Quartile Range|Median
2582509|NCT02377817|Secondary|Sleep Latency|This is a standard polysomnography measure of the amount of time (in minutes) that it takes a participant to transition from full wakefulness to sleep.|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||minutes||Inter-Quartile Range|Median
2582510|NCT02377817|Secondary|Percentage Sleep Right|Percentage (%) of sleeping time in the right-lateral position.|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||percentage of sleep time (%)||Standard Deviation|Mean
2582511|NCT02377817|Secondary|Percentage Sleep Left|Percentage (%) of sleeping time in the left-lateral position.|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||percentage of sleep time (%)||Standard Deviation|Mean
2582512|NCT02377817|Secondary|Right-lateral Sleep Time|Time (in minutes) spent sleeping in the right-lateral position.|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||minutes||Standard Deviation|Mean
2582513|NCT02377817|Secondary|Left-lateral Sleep Time|Time (in minutes) spent sleeping in the left-lateral position.|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||minutes||Standard Deviation|Mean
2582514|NCT02377817|Secondary|Supine Sleep Time|The time (in minutes) spent sleeping in the supine position.|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||minutes||Inter-Quartile Range|Median
2582515|NCT02377817|Secondary|Total Sleep Time|This is a standard polysomnography measure of the amount of time the participant spent sleeping during the sleep test.|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||minutes||Inter-Quartile Range|Median
2582516|NCT02377817|Primary|Percentage (%) of Sleep Time Supine|Proportion of sleeping time spent in the supine position|1 night (approximately 8 hours)|Twenty (n=20) participants completed the study. Each of these participants spent two nights in the sleep lab - one night wearing the PrenaBelt and one night wearing the sham PrenaBelt. This constitutes 40 nights (20 nights with the PrenaBelt and 20 nights with the sham PrenaBelt).|||percentage of sleep time (%)||Inter-Quartile Range|Median
2582517|NCT02377466|Secondary|Volume of Distribution of Retosiban|Maternal blood samples were collected at the indicated time points for pharmacokinetic analysis. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).|Day 1 (2 to 4 hours, 10 to 14 hours) and Day 2 (22 to 26 hours, and 48 to 54 hours) post-infusion|Maternal Safety Population. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).|||Liters||Geometric Coefficient of Variation|Geometric Mean
2582518|NCT02377466|Secondary|Retosiban Clearance|Maternal blood samples were collected at the indicated time points for pharmacokinetic analysis. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).|Day 1 (2 to 4 hours, 10 to 14 hours) and Day 2 (22 to 26 hours, and 48 to 54 hours) post-infusion|Maternal Safety Population. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2582519|NCT02377466|Secondary|Number of Participants With Different Modes of Transportation to Hospital|The means by which the maternal participants were transported to the hospital i.e. ground ambulance/emergency vehicle (gr. amb/emer. veh), air ambulance, family member or other means were obtained from the review of medical records. The number of maternal participants with the corresponding mode of transportation is presented for preterm labor visit and delivery visit. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).|Up to 28 days post EDD (40 0/7 weeks gestation)|Maternal Safety Population|||Participants|||Number
2582520|NCT02377466|Secondary|Number of Participants Admitted to Particular Hospital Unit|Maternal healthcare resource utilization associated with an episode of preterm labor, preterm delivery and normal term delivery were collected from the review of medical records. The number of participants who were admitted to a particular hospital unit has been presented.|Up to 28 days post EDD (40 0/7 weeks gestation)|Maternal Safety Population|||Participants|||Number
2582556|NCT02377466|Secondary|Length of Stay in Specialized Care Unit|Neonatal healthcare resource utilization was collected from review of medical records. The length of stay in a specialized care unit (NICU or ICU) has been presented for neonatal participants with admission to ICU or NICU.|Up to 28 days post EDD (40 0/7 weeks gestation)|Neonatal Safety Population.|||Days||Standard Deviation|Mean
2582521|NCT02377466|Secondary|Number of Participants With Hospital Admissions Related to Preterm Labor and Preterm Delivery|Maternal healthcare resource utilization associated with an episode of preterm labor and preterm delivery were collected from the review of medical records. One participant in the retosiban arm did not have hospitalization data; hence, was excluded from the analysis at delivery. The number of participants who had hospital admission for preterm labor and preterm delivery has been presented. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|Up to 28 days after EDD (40 0/7 weeks of gestation)|Maternal Safety Population|||Participants|||Number
2582522|NCT02377466|Secondary|Maternal Length of Stay in Hospital|Details on maternal health care resource use (both for hospitalizations related to preterm labor not resulting in a delivery and hospitalizations related to preterm labor/normal labor resulting in a delivery) associated with an episode of preterm labor, preterm delivery and normal term delivery (>= 37 weeks gestation) were collected from review of medical records. Length of hospital stay associated with hospital admission for preterm labor and normal term labor/term delivery is presented. One participant in the retosiban arm did not have hospitalization data; hence, was excluded from the analysis at delivery. Only participants with data available at the specified time points were analyzed (indicated by n=X) in category titles. NA indicates standard deviation could not be calculated as only one participant was analyzed.|Up to 28 days post EDD (40 0/7 weeks gestation)|Maternal Safety Population|||Days||Standard Deviation|Mean
2582523|NCT02377466|Secondary|Number of Neonatal Participants With DRE|The disease related neonatal events occurring in Infants born prior to 37 completed weeks included: apnea (severe), respiratory failure due to fatigue, hypoxia, or air leak from alveolar injury, patent ductus arteriosus, bradycardia, ventriculomegaly, cerebellar hemorrhage, hydrocephalus other than congenital, gastroesophageal reflux, aspiration pneumonia, anemia, retinopathy of prematurity (all stages), hearing disorder, temperature instability and hypoglycemia. The number of participants with at least one DRE has been presented.|Up to 28 days after EDD of 40 weeks gestation|Neonatal Safety Population|||Participants|||Number
2582524|NCT02377466|Secondary|Number of Neonatal Participants With AESI|Neonatal AESI included: Neonatal death; Asphyxia; Infections (early onset neonatal sepsis, septic shock, pneumonia, meningitis); RDS; Hypotension; IVH/periventricular leukomalacia; Bronchopulmonary dysplasia; Neonatal acidosis; Hyperbilirubinemia; Necrotizing enterocolitis; and Hypoxic ischemic encephalopathy. The number of neonatal participants who experienced at least one AESI has been presented.|Up to 28 days after EDD of 40 weeks gestation|Neonatal Safety Population|||Participants|||Number
2582525|NCT02377466|Secondary|Number of Neonatal Participants With AEs and SAEs|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. The number of participants who experienced at least one AE and one SAE has been presented. Neonatal Safety Population consisted of neonates whose mothers received randomized treatment.|Up to 28 days after the EDD of 40 weeks gestation|Neonatal Safety Population|||Participants|||Number
2582526|NCT02377466|Secondary|Head Circumference of Neonates|The head circumference was determined from the neonate birth record.|Up to 17 weeks|Neonatal ITT Population|||centimeters (cm)||Standard Deviation|Mean
2582527|NCT02377466|Secondary|Weight of Neonates|The weight of neonates was obtained from the neonate birth record. The mean weight of neonates and standard deviation has been presented.|Up to 17 weeks|Neonatal ITT Population|||grams (g)||Standard Deviation|Mean
2582528|NCT02377466|Secondary|Neonatal APGAR Scores|APGAR is a quick test to assess the health of new born children. The test is performed at 1 and 5 minutes after birth. APGAR scale is determined by evaluating the new born on five categories (appearance, pulse, grimace, activity and respiration) on a scale from zero to two, then summing up the five values obtained. APGAR score ranges from 0 to 10 where a score of 7 and above is normal. The mean and standard deviation of APGAR scores at one minute and at five minutes of birth has been presented.|Up to 5 minutes after birth|Neonatal ITT Population|||Score on APGAR scale||Standard Deviation|Mean
2582529|NCT02377466|Secondary|Number of Participants With Fetal AESI|Fetal AESI included: intrauterine fetal demise; category II or III fetal heart rate tracing; and fetal inflammatory response syndrome characterized by cord blood interleukin-6 >11 picogram per milliliter (pg/mL), funisitis, or chorionic vasculitis. The number of participants who experienced at least one AESI has been presented.|Up to 17 weeks|Maternal Safety Population|||Participants|||Number
2582530|NCT02377466|Secondary|Number of Participants With Fetal Acidosis|The number of participants with fetal acidosis is presented.|Up to 16 weeks|Maternal Safety Population|||Participants|||Number
2582531|NCT02377466|Secondary|Number of Fetal Participants With AEs and SAEs Prior to Delivery|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. Fetal AEs and SAEs included the adverse events that were experienced by the fetus prior to delivery. The number of fetal participants who experienced at least one AE and one SAE has been presented.|Up to 17 weeks post-infusion|Maternal Safety Population|||Participants|||Number
2582532|NCT02377466|Secondary|Number of Maternal Participants With Disease Related AEs (DRE)|Maternal DREs included: signs and symptoms of labor discomfort (example, cramping, backache, muscle aches, nausea); subsequent episodes of preterm labor and hospitalization for delivery. The number of participants with at least one DRE has been presented.|Up to 6 weeks post-delivery|Maternal Safety Population|||Participants|||Number
2582762|NCT02374398|Secondary|Adverse Events|Complications: deep venous thrombosis(DVT) or arterial thrombosis, pulmonary embolism(PE), myocardial infarction (MI), cerebrovascular accident (CVA)|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups||||participants|||Number
2582533|NCT02377466|Secondary|Number of Maternal Participants With AEs of Special Interest (AESI).|Maternal AESI included: maternal death; chorioamnionitis and its complications (clinical chorioamnionitis, preterm premature rupture of membranes, endomyometritis, wound infection, pelvic abscess, bacteremia, septic shock, disseminated intravascular coagulation, and adult RDS); placental abruption; postpartum hemorrhage - postpartum hemorrhage and/or retained placenta and pulmonary edema. The number of participants with at least one AESI has been presented.|Up to 6 weeks post-delivery|Maternal Safety Population|||Participants|||Number
2582534|NCT02377466|Secondary|Number of Maternal Participants With a Score of 12 or Higher on the Edinburgh Postnatal Depression Scale (EPDS)|The effect of preterm birth on maternal health status was assessed using the EPDS. The EPDS is a 10-item self-reported assessment of depression, validated for administration during both the antenatal and the post-natal periods. Items are rated on a 4-point variable Likert scale, ranging from 0 to 3. The total score was calculated by adding individual scores for each item and ranged from 0 to 30. A score of less than 8 indicates depression not likely; score of 9 to 11 indicates possible depression and a score of more than 12 indicates an increased probability of depression. Maternal participants were required to complete the EPDS at the maternal follow-up assessment 6 weeks post-delivery.|Up to 6 weeks post delivery|Maternal Safety Population|||Participants|||Number
2582535|NCT02377466|Secondary|Number of Participants Who Discontinued Study Treatment Due to Clinical and Laboratory Toxicities|Number of maternal participants who discontinued study treatment due to clinical and laboratory toxicities is presented.|Up to 48 hours post-infusion|Maternal Safety Population|||Participants|||Number
2582536|NCT02377466|Secondary|Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels|Blood samples were collected for the evaluation of change from Baseline in levels of direct bilirubin, bilirubin, indirect bilirubin, creatinine and urate. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||micromoles per liter (µmol/L)||Standard Deviation|Mean
2582537|NCT02377466|Secondary|Change From Baseline in Anion Gap, Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level|Blood samples were collected for the evaluation of change from Baseline in levels of anion gap, calcium, chloride, carbon dioxide, glucose, potassium, magnesium, phosphate, and sodium. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2582538|NCT02377466|Secondary|Change From Baseline in Albumin and Protein Levels|Blood samples were collected for the evaluation of change in albumin and protein levels from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||grams per liter (g/L)||Standard Deviation|Mean
2582539|NCT02377466|Secondary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels|Blood samples were collected for the evaluation of change in ALP, ALT, AST, GGT and LDH from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||International Units per liter (IU/L)||Standard Deviation|Mean
2582540|NCT02377466|Secondary|Change From Baseline in Erythrocyte Level|Blood samples were collected for the evaluation of change in erythrocyte level from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||Trillion cells per liter||Standard Deviation|Mean
2582541|NCT02377466|Secondary|Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV)|Blood samples were collected for the evaluation of change in MCV and MPV from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||femtoliter (fL)||Standard Deviation|Mean
2582542|NCT02377466|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count|Blood samples were collected for the evaluation of change in basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes count. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||Billion cells per liter (L)||Standard Deviation|Mean
2582543|NCT02377466|Secondary|Change From Baseline in Hemoglobin and Erythrocyte Mean Corpuscular Hemoglobin Concentration (MCHC)|Blood samples were collected for the evaluation of change in hemoglobin levels and MCHC from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||grams per liter (g/L)||Standard Deviation|Mean
2582544|NCT02377466|Secondary|Change From Baseline in Hematocrit Levels|Blood samples were collected for the evaluation of change in hematocrit levels from Baseline. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
2582545|NCT02377466|Secondary|Change From Baseline in Respiratory Rate|Respiratory rate was measured with the participants in a semirecumbent or seated position. Respiratory rate was measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||breaths per minute||Standard Deviation|Mean
2582546|NCT02377466|Secondary|Change From Baseline in Temperature|Temperature was measured with the participants in a semirecumbent or seated position. Temperature was measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||degree Celsius||Standard Deviation|Mean
2582547|NCT02377466|Secondary|Change From Baseline in Heart Rate|Heart rate was measured with the participants in a semirecumbent or seated position. Heart rate was measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 9 days|Maternal Safety Population|||beats per minute||Standard Deviation|Mean
2582548|NCT02377466|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)|SBP and DBP were measured with participants in a semirecumbent or seated position. SBP and DBP were measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 9 days|Maternal Safety Population|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2582549|NCT02377466|Secondary|Number of Maternal Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that mey require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. Maternal Safety Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment. The number of maternal participants who experienced at least one AE and one SAE has been presented.|Up to 6 weeks after delivery|Maternal Safety Population|||Participants|||Number
2582550|NCT02377466|Secondary|Number of Participants With Subsequent Preterm Labor|The participants who had not delivered after 48 hours post-infusion were contacted to determine if they had delivered or experienced any subsequent episodes of preterm labor. A subsequent episode of preterm labor was only recorded if the participant reported it to the Principal Investigator during one of the telephone follow-up calls but did not then go on to immediately deliver. However, if labor started and led to immediate delivery, then the only data collected would be the pre-specified delivery data and thus would not be counted as a subsequent episode of preterm labor. The number of participants who had a subsequent episode of preterm labor after administration of the study treatment has been presented. Maternal Safety Population comprised of all maternal participants randomly assigned to treatment who have been exposed to study treatment.|Up to 11 weeks|Maternal Safety Population|||Participants|||Number
2582551|NCT02377466|Secondary|Number of Participants Who Received Any Putative Tocolytic|A putative tocolytic medication was the medication administered for active preterm labor or as prevention of preterm labor and included calcium channel blockers, nonsteroidal anti-inflammatory drugs, or beta agonists, or magnesium sulfate doses that exceeded prespecified IV loading doses, infusion rates, or total duration of administration.|Up to 17 weeks|Maternal Safety Population|||Participants|||Number
2582552|NCT02377466|Secondary|Time to Treatment Failure|Treatment failure is defined as the administration of any putative tocolytic medication for treatment of preterm labor or as prophylaxis of preterm labor. Time to treatment failure is the number of days from the first dose of study treatment until treatment failure. The mean number of days to delivery or treatment failure along with standard deviation has been presented. Only those maternal participants with treatment failure were included in the analysis. NA indicates standard deviation could not be calculated as only one participant was analyzed.|Up to 17 weeks|Maternal ITT Population|||Days||Standard Deviation|Mean
2582553|NCT02377466|Secondary|Number of Participants With Ambulatory Surgery|Information regarding participants who had ambulatory surgery was collected from the newborn medical records. The number of neonatal participants with ambulatory surgery is presented.|Up to 28 days post EDD (40 0/7 weeks gestation)|Neonatal Safety Population|||Participants|||Number
2582554|NCT02377466|Secondary|Length of Stay Following Readmission to Hospital|Newborn hospital readmission following hospitalization for birth was collected from the newborn's medical records. Length of stay in hospital following readmission is presented for neonates.|Up to 28 days after EDD (40 0/7 weeks gestation)|Neonatal Safety Population|||Days||Full Range|Median
2582555|NCT02377466|Secondary|Number of Newborn Participants With Hospital Readmission|Newborn hospital readmission following hospitalization for birth was collected from the newborn's medical records. The number of newborn participants who had readmission to hospital is presented.|Up to 28 days of EDD (40 0/7 weeks gestation)|Neonatal Safety Population|||Participants|||Number
2582763|NCT02374398|Secondary|Cost Analysis|Charges per case.|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups||||Dollars||Standard Deviation|Mean
2582557|NCT02377466|Secondary|Number of Neonatal Participants With Admission to a Particular Hospital Unit|Neonatal healthcare resource utilization was collected from review of medical records. The number of neonatal participants who were admitted to a particular hospital unit that is, level III (or higher) intensive neonatal care (NICU), Intensive care unit (ICU), general ward, Level I - Basic Neonatal care, Well born nursery (SCBU) and Level II-Special Care Newborn nursery high dependency (NHDU) has been summarized. Neonatal Safety Population consisted of neonates whose mothers received study treatment.|Up to 28 days post EDD (40 0/7 weeks gestation)|Neonatal Safety Population|||Participants|||Number
2582558|NCT02377466|Secondary|Number of Neonates With Each Individual Component of the Composite Neonatal Morbidity and Mortality|The neonatal composite endpoint was determined from review of medical records and included the following components: fetal or neonatal death, RDS, bronchopulmonary dysplasia, necrotizing enterocolitis or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, retinopathy of prematurity, IVH, white matter injury and cerebellar hemorrhage. The number of neonates with each individual component of the composite component has been presented.|Up to 28 days after the EDD of 40 0/7 weeks|Neonatal ITT Population|||Participants|||Number
2582559|NCT02377466|Secondary|Number of Neonates With Any of the Co-primary Composite Neonatal Morbidity and Mortality, Excluding RDS|The neonatal composite endpoint was determined from review of medical records and included the following components: fetal or neonatal death, RDS, bronchopulmonary dysplasia, necrotizing enterocolitis or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, retinopathy of prematurity, IVH, white matter injury and cerebellar hemorrhage. The number of neonates with any co-primary composite neonatal morbidity and mortality component, excluding RDS has been presented.|Up to 28 weeks after EDD (40 weeks gestation)|Neonatal ITT Population|||Participants|||Number
2582560|NCT02377466|Secondary|Number of Participants With Births at <=24 Hours From the First Study Treatment|The number of participants who delivered in less than or equal to 24 hours from first dose of study treatment has been presented.|Up to 24 hours|Maternal ITT Population|||Participants|||Number
2582561|NCT02377466|Secondary|Number of Participants With Births at <=48 Hours From the First Study Treatment|The number of participants who delivered in less than or equal to 48 hours from first dose of study treatment has been presented.|Up to 48 hours|Maternal ITT Population|||Participants|||Number
2582562|NCT02377466|Secondary|Number of Participants With Births <=7 Days From the First Study Treatment|The number of participants who delivered in less than or equal to 7 days from first dose of study treatment has been presented.|Up to 7 days|Maternal ITT Population|||Participants|||Number
2582563|NCT02377466|Secondary|Number of Participants With Births Prior to 28 0/7 Weeks Gestation|The number of participants who delivered prior to 28 0/7 weeks gestation has been presented. Only those maternal participants who were randomized prior to 28 0/7 week's gestation and delivered were included.|Up to 4 weeks|Maternal ITT Population|||Participants|||Number
2582564|NCT02377466|Secondary|Number of Participants With Births Prior to 32 0/7 Weeks Gestation|The number of participants who delivered prior to 32 0/7 weeks gestation has been presented. Only those maternal participants who were randomized prior to 32 0/7 week's gestation and delivered were included.|Up to 8 weeks|Maternal ITT Population|||Participants|||Number
2582565|NCT02377466|Secondary|Number of Participants With Births Prior to 35 0/7 Weeks Gestation|The number of participants who delivered prior to 35 0/7 weeks gestation has been presented.|Up to 11 weeks|Maternal ITT Population|||Participants|||Number
2582566|NCT02377466|Secondary|Length of Neonatal Hospital Stay|The length of stay was collected from medical records and was calculated as the days between the delivery date and time and discharge date and time.|Up to 28 days post EDD of 40 0/7 weeks gestation|Neonatal ITT Population|||Days||Standard Deviation|Mean
2582567|NCT02377466|Secondary|Number of Participants With Births at Term|Participants were considered to have delivered at term if the gestational age was >=37 0/7. The number of participants who delivered at term, that is, 37 0/7 to 41 6/7 weeks gestation has been presented.|Up to 17 weeks|Maternal ITT Population|||Participants|||Number
2582568|NCT02377466|Secondary|Number of Participants With Births Prior to 37 0/7 Weeks Gestation|Gestational age at birth (weeks) is defined as the gestational age when the baby is born. Participants were considered to have delivered prior to 37 0/7 weeks, that is preterm, if the gestational age at birth is less than 37 0/7 weeks. The number of participants who delivered prior to 37 0/7 weeks gestation has been presented.|Up to 13 weeks|Maternal ITT Population|||Participants|||Number
2582569|NCT02377466|Secondary|Time to Delivery|The time to delivery was calculated as the days between the delivery and start time of the study treatment infusion using the formula: Time to delivery (days) = (date and time of delivery minus date and time of start of infusion) divided by (24 multiplied by 60). The mean number of days to delivery along with standard deviation has been presented.|Up to 17 weeks|Maternal ITT Population|||Days||Standard Deviation|Mean
2582570|NCT02377466|Primary|Number of Neonates With Any Diagnosis From the Neonatal Morbidity and Mortality Composite Component|The neonatal composite endpoint was determined from review of medical records and included the following components: fetal or neonatal death, respiratory distress syndrome (RDS), bronchopulmonary dysplasia, necrotizing enterocolitis or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, retinopathy of prematurity, intraventricular hemorrhage (IVH), white matter injury and cerebellar hemorrhage. Neonates with any of the composite component has been presented. Statistical analysis was not performed due to early termination of study and resultant small sample size. Neonatal ITT Population comprised of all neonates whose mothers were the randomized participants who have been exposed to study treatment, that is, mothers from the ITT Population.|Up to 28 days after the estimated date of delivery (EDD) of 40 0/7 weeks|Neonatal ITT Population|||Participants|||Number
2582639|NCT02377349|Secondary|Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were determined by ELISA, tabulated as GMCs and expressed in IU/mL.|One month post vaccination (Day 30) during pregnancy|The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 2 were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2582571|NCT02377466|Primary|Time to Delivery or Treatment Failure, Whichever Occurs First|Time to delivery or treatment failure is the number of days from the first dose of study treatment until delivery or treatment failure whichever occurs first. Treatment failure is defined as the administration of any putative tocolytic medication for treatment of preterm labor or as prophylaxis of preterm labor. Maternal intent-to-treat (ITT) Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment irrespective of their compliance to the planned course of treatment. The mean number of days to delivery or treatment failure along with standard deviation has been presented. Statistical analysis was not performed due to early termination of the study and resultant small sample size.|Up to 17 weeks|Maternal ITT Population|||Days||Standard Deviation|Mean
2582572|NCT02377427|Secondary|Ratio to Baseline in Absolute Blood Eosinophil Count at Weeks 32, 44, 56, 68, 72 and 80 for Part B|Blood samples were collected at the indicated time points for the analysis of eosinophil count. Baseline was defined as the latest value recorded prior to the first dose of mepolizumab in Part A. Ratio to Baseline was calculated as post-dose visit value/Baseline value. The analysis was based on Pharmacodynamic (Blood Eosinophils) (PDe) Population comprised of all participants receiving at least one dose of mepolizumab beginning at Visit 9 and having at least one Part B blood sample taken for blood eosinophil count. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 32, 44, 56, 68, 72 and 80|PDe Population|||Ratio of eosinophils in blood||95% Confidence Interval|Geometric Mean
2582573|NCT02377427|Secondary|Change From Baseline in Sitting Pulse Rate in Part A|Sitting pulse rate measurements was performed in Part A at indicated time points. Measurements were done pre-infusion/injection with the participant sitting, having rested in this position for at least 5 minutes before each reading. The Baseline was defined as the latest value recorded prior to the first dose of mepolizumab. Change from Baseline was defined as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 4, 8, 9, 12, 16 and 20|Safety Population|||Beats per minute||Standard Deviation|Mean
2582574|NCT02377427|Secondary|Change From Baseline in Sitting SBP and DBP in Part A|Sitting blood pressure measurements were performed in Part A at indicated time points. Measurements were done pre-infusion/injection with the participant sitting, having rested in this position for at least 5 minutes before each reading. The Baseline was defined as the latest value recorded prior to the first dose of mepolizumab. Change from Baseline was defined as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 4, 8, 9, 12, 16 and 20|Safety Population|||mmHg||Standard Deviation|Mean
2582575|NCT02377427|Secondary|Number of Participants With Positive Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies Response in Part A|Blood sample for immunogenicity was collected for anti-mepolizumab binding antibodies and neutralizing antibodies response in Part A at indicated time points prior to study treatment administration. Number of participants with positive anti-mepolizumab binding antibodies and neutralizing antibodies response was summarized. Participant was considered 'Positive' if they had at least one positive post-baseline assay result. Any Time Post Baseline has been presented, which included all visits (including scheduled and unscheduled) post-baseline was considered for this visit derivation. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 16 and 20|Safety Population|||Participants|||Number
2582576|NCT02377427|Secondary|Number of Participants With Abnormal Findings for Urinalysis in Part A|Urine samples were collected from participants at indicated time points for analysis of urinalysis parameters including specific gravity and pH of urine, presence of glucose, protein, blood and ketones in urine by dipstick test. Microscopic examination was performed if blood or protein was abnormal. Only those participants with data available at the specified time points were analyzed.|Up to Week 20|Safety Population|||Participants|||Number
2582577|NCT02377427|Secondary|Number of Participants With Any Time Change From Baseline Relative to Normal Range in Clinical Chemistry Parameters in Part A|"Blood samples were collected for analysis of ALT, ALP, AST, GGT, albumin, protein, total billirubin, creatinine, direct billirubin, urate, calcium, CO2, chloride, glucose, potassium, sodium and urea. Baseline was defined as the latest value recorded prior to the first dose of mepolizumab. Change from Baseline was defined as value at indicated time point minus Baseline value. Any time post Baseline = all visits (including scheduled and unscheduled) post Baseline was considered for this visit derivation. If participant had at least one value for categories To Low and/or To High along with To Normal or No Change then participant was counted under To Low and/or To High. If participant had values which belong only to To Normal or No Change then participant was counted under To Normal or No Change only. Any Time Post-Baseline values have been presented."|Baseline and up to Week 20|Safety Population|||Participants|||Number
2582578|NCT02377427|Secondary|Number of Participants With Any Time Change From Baseline Relative to Normal Range in Hematology Parameters in Part A|"Blood samples were collected for analysis of basophils, eosinophils, leukocyte, monocyte, neutrophils, lymphocyte, platelet count, MCH, MCHC, Hgb, MCV, erythrocytes, hematocrit, and Ret/Ery. The Baseline was the latest value recorded prior to the first dose of mepolizumab. Change from Baseline was defined as value at indicated time point minus Baseline value. Any time post Baseline = all visits (scheduled and unscheduled) post Baseline was considered for this visit derivation. If participant had at least one value for categories To Low and/or To High along with To Normal or No Change then participant was counted under To Low and/or To High. If participant had values which belong only to To Normal or No Change then participant was counted under To Normal or No Change only. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Any Time Post-Baseline values have been presented."|Baseline and up to Week 20|Safety Population|||Participants|||Number
2582594|NCT02377427|Primary|Terminal Phase Elimination Half-life (T1/2) of Mepolizumab During Treatment Period for Part A|PK of mepolizumab was evaluated in participants using t1/2. PK samples were collected at pre-dose on Weeks 4 and 8; and at Weeks 9, 12, 16 and 20 post-dose. T1/2 was evaluated by population PK methods and mean and standard error from the final model has been tabulated. Estimates have been presented from the final model centered to mean bodyweights of 27 kg, 50 kg and 70 kg. Note the average bodyweight of 70kg (mean body weight observed in adults) was not investigated in the study.|Pre-dose on Weeks 4 and 8; Weeks 9, 12, 16 and 20 post-dose|PK Population|||Days||Standard Error|Mean
2582579|NCT02377427|Secondary|Number of Participants With on Treatment SAEs and Non-SAEs in Part A|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Participants who received any of the study treatment and had any on-treatment non-SAE or SAE (defined as events occurring from the first dose until 28 days after the last dose of mepolizumab) were considered for analysis.|Up to Week 20|Safety Population|||Participants|||Number
2582580|NCT02377427|Secondary|Change From Baseline in C-ACT at Weeks 4,8,16 and 20 in Part A|The C-ACT assesses asthma control in children 4-11 years of age. The C-ACT is a 7-question, 2-part questionnaire, with items 1 to 4 were completed by the child (with assistance from a caregiver, as needed) and items 5 to 7 were completed by the caregiver. A total sum score based upon responses to all items was calculated to provide an overall measure of asthma control. The derived C-ACT score ranges from 0 (maximum impairment) to 27 (no impairment), where higher scores represent a better outcome. Baseline was defined as the latest value recorded prior to the first dose of mepolizumab. Change from Baseline was calculated as score obtained at the indicated time point minus Baseline Score. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 4,8,16 and 20|PDo Population|||Scores on a scale||Standard Deviation|Mean
2582581|NCT02377427|Secondary|Change From Baseline in Childhood Asthma Control Test (C-ACT) at Week 12 for Part A|The C-ACT assesses asthma control in children 4-11 years of age. The C-ACT is a 7-question, 2-part questionnaire, with items 1 to 4 were completed by the child (with assistance from a caregiver, as needed) and items 5 to 7 were completed by the caregiver. A total sum score based upon responses to all items was calculated to provide an overall measure of asthma control. The derived C-ACT score ranges from 0 (maximum impairment) to 27 (no impairment), where higher scores represent a better outcome. Baseline was defined as the latest value recorded prior to the first dose of mepolizumab. Change from Baseline was calculated as score obtained at Week 12 minus Baseline Score.|Baseline and Week 12|PDo Population. Only those participants with data available at specific time point were analyzed.|||Scores on a scale||Standard Deviation|Mean
2582582|NCT02377427|Secondary|Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) at Weeks 4,8,16 and 20 in Part A|ACQ-7 is a simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or a result of treatment. The ACQ-7 uses a 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7=category for FEV1%). The instrument has a reported high test-retest reproducibility with an intraclass correlation coefficient =0.90. The minimally important change in score is 0.5. Baseline was defined as the latest value recorded prior to the first dose of mepolizumab. Change from Baseline was calculated as score obtained at the indicated time point minus Baseline Score. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 4,8,16 and 20|PDo Population|||Scores on a scale||Standard Deviation|Mean
2582583|NCT02377427|Secondary|Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) at Week 12 in Part A|ACQ-7 is a simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or a result of treatment. The ACQ-7 uses a 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 = category for forced expiratory volume in 1 second [FEV1]%). The instrument has a reported high test-retest reproducibility with an intraclass correlation coefficient =0.90. The minimally important change in score is 0.5. Baseline was defined as the latest value recorded prior to the first dose of mepolizumab. Change from Baseline was calculated as score obtained at Week 12 minus Baseline Score. Pharmacodynamic Outcome (PDo) Population included all participants who received at least one dose of mepolizumab beginning at Visit 2 and having at least one Part A assessment of pharmacodynamic outcomes.|Baseline and Week 12|PDo Population. Only those participants with data available at specific time point were analyzed.|||Scores on a scale||Standard Deviation|Mean
2582584|NCT02377427|Secondary|Body Weight-adjusted Apparent Clearance of Mepolizumab for Part A|PK samples were collected at pre-dose on Weeks 4 and 8; and at Weeks 9, 12, 16 and 20 post-dose. The body weight-adjusted apparent clearance was compared between adults and participants aged 6 to 11 years old with severe eosinophilic asthma when mepolizumab was administered subcutaneously. Point estimate and 90% confidence interval (CI) for participants aged 6 to 11 years (centered to a mean bodyweight of 70 kg) was compared with the historic adult estimated body-weight adjusted clearance of 0.22 L/day, around which a proposed 80-125% interval was applied i.e. 0.18-0.28 L/day. Assuming an absolute bioavailability of 75% this corresponds to an apparent clearance of 0.29 L/day with the proposed 80% to 125% interval of 0.23 to 0.36 L/day. Note the average bodyweight of 70kg (mean body weight observed in adults) was not observed in the study.|Pre-dose on Weeks 4 and 8; Weeks 9, 12, 16 and 20 post-dose|PK Population|||L/day||90% Confidence Interval|Mean
2582585|NCT02377427|Primary|Number of Participants With Abnormal Findings for Urinalysis Parameters in Part B|Urine samples were collected from participants at indicated time points for analysis of urinalysis parameters including Specific gravity and potential of hydrogen (pH) of urine, presence of glucose, protein, blood and ketones in urine by dipstick test. Microscopic examination was performed if blood or protein was abnormal. Only those participants with data available at the specified time points were analyzed.|From Week 20 and up to Week 72|Safety Population|||Participants|||Number
2582595|NCT02377427|Primary|Area Under Concentration Time Curve to Infinity (AUC [0-inf]) of Mepolizumab for Part A|PK of mepolizumab was evaluated in participants using AUC (0-inf). PK samples were collected at pre-dose on Weeks 4 and 8; and at Weeks 9, 12, 16 and 20 post-dose. AUC (0-inf) was evaluated by population PK methods and mean and standard error from the final model has been tabulated. Estimates have been presented from the final model centered to mean bodyweights of 27 kg, 50 kg and 70 kg. Note the average bodyweight of 70kg (mean body weight observed in adults) was not investigated in the study.|Pre-dose on Weeks 4 and 8; Weeks 9, 12, 16 and 20 post-dose|PK Population|||Day*ug per mL||Standard Error|Mean
2582701|NCT02376166|Secondary|Episodes of Nausea|Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 5th reported outcome - Number of episodes of nausea|6 months||||episodes|||Number
2582586|NCT02377427|Primary|Number of Participants With Any Time Change From Baseline Relative to Normal Range in Hematology Parameters for Part B|"Blood samples were collected for analysis of basophils, eosinophils, leukocyte, monocyte, neutrophils, lymphocyte, platelets, mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), hemoglobin (Hgb), mean corpuscular volume (MCV), erythrocytes, hematocrit, and reticulocytes/erythrocytes (Ret/Ery). Baseline was defined as the latest value recorded prior to first dose of mepolizumab in Part A. Change from Baseline was defined as value at indicated time point minus Baseline value. All Part B visits (scheduled and unscheduled) post-Baseline were considered for Any-time Post-Baseline visit derivation. If participant had at least one value for categories To Low and/or To High along with To Normal or No Change then participant was counted under To Low and/or To High. If participant had values which belong only to To Normal or No Change then participant was counted under To Normal or No Change only. Any Time Post-Baseline values have been presented."|Baseline, from Week 20 and up to Week 80|Safety Population|||Participants|||Number
2582587|NCT02377427|Primary|Number of Participants With Any Time Change From Baseline Relative to Normal Range in Clinical Chemistry Parameters for Part B|"Blood samples were collected for analysis of alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), albumin, protein, bilirubin, creatinine, urate, direct bilirubin, calcium, carbon dioxide (CO2), chloride, glucose, potassium, sodium and urea. Baseline was defined as the latest value recorded prior to the first dose of mepolizumab in Part A. Change from Baseline was defined as value at indicated time point minus Baseline value. All Part B visits (scheduled and unscheduled) post-Baseline were considered for Any-time Post-Baseline visit derivation. If participant had at least one value for categories To Low and/or To High along with To Normal or No Change then participant was counted under To Low and/or To High. If participant had values which belong only to To Normal or No Change then participant was counted under To Normal or No Change only. Any Time Post-Baseline values have been presented."|Baseline, from Week 20 and up to Week 72|Safety Population|||Participants|||Number
2582588|NCT02377427|Primary|Change From Baseline in Sitting Pulse Rate for Part B|Sitting pulse rate measurements were performed pre-infusion/injection with the participant sitting, having rested in this position for at least 5 minutes before each reading. The Baseline was defined as the latest value recorded prior to the first dose of mepolizumab in Part A. Change from Baseline was defined as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 80|Safety Population|||Beats per minute||Standard Deviation|Mean
2582589|NCT02377427|Primary|Change From Baseline in Sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) for Part B|Sitting blood pressure measurements included SBP and DBP. Measurements were done pre-infusion/injection with the participant sitting, having rested in this position for at least 5 minutes before each reading. The Baseline was defined as the latest value recorded prior to the first dose of mepolizumab. Change from Baseline was defined as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 80|Safety Population|||Millimeter of mercury||Standard Deviation|Mean
2582590|NCT02377427|Primary|Number of Participants With Positive Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies Response for Part B|Blood sample were collected for the determination of anti-mepolizumab binding antibodies and neutralizing antibodies response in Part B at Weeks 44, 68 and 80 prior to study treatment administration. Participant was considered 'Positive' if they had at least one positive post-Baseline anti-drug antibody assay result. All Part B visits (including scheduled and unscheduled) post-Baseline were considered for Any-time Post-Baseline visit derivation. The number of participants with positive anti-mepolizumab binding antibodies and neutralizing antibodies response at Any Time Post Baseline has been presented. The neutralizing antibodies response results only presented for participants with positive anti-drug antibody assay.|From Week 20 and up to Week 80|Safety Population|||Participants|||Number
2582591|NCT02377427|Primary|Number of Participants With on Treatment Serious Adverse Events (SAEs) and Non-SAEs for Part B|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia are to be categorized as SAE. On-treatment SAEs and non-SAEs are defined as events occurring from the first Part B dose until 28 days following the last Part B dose. Safety Population includes all participants who received at least one dose of mepolizumab beginning at Visit 9.|From Week 20 and up to Week 72|Safety Population|||Participants|||Number
2582592|NCT02377427|Primary|Ratio to Baseline in Absolute Blood Eosinophil Count at Week 12 for Part A|PD of mepolizumab was evaluated in participants using ratio to Baseline in absolute blood eosinophil count. Blood samples were collected at indicated time points. Baseline was defined as the latest value recorded prior to the first dose of mepolizumab. Ratio to Baseline was calculated as post-dose visit value/Baseline value. It was evaluated by Pharmacodynamic Eosinophils (PDe) Population which included all participants receiving at least one dose of mepolizumab beginning at Visit 2 (Week 0) and having at least one Part A blood sample evaluable for blood eosinophil count.|Baseline and Week 12|PDe Population. Only those participants with data available at specific time point were analyzed.|||Ratio of eosinophils in blood||95% Confidence Interval|Geometric Mean
2582593|NCT02377427|Primary|Plasma Apparent Clearance (CL/F) of Mepolizumab in Part A|PK of mepolizumab was evaluated in participants using CL/F. PK samples were collected at pre-dose on Weeks 4 and 8; and at Weeks 9, 12, 16 and 20 post-dose. CL was evaluated by population PK methods and mean and standard error from the final model has been tabulated. Estimates have been presented from the final model centered to mean bodyweights of 27 kg, 50 kg and 70 kg. Note the average bodyweight of 70kg (mean body weight observed in adults) was not investigated in the study.|Pre-dose on Weeks 4 and 8; Weeks 9, 12, 16 and 20 post-dose|PK Population|||Liter (L) per day||Standard Error|Mean
2582625|NCT02377362|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Non-Zero Concentration (AUC0-t) (Part B)||Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28||||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2582596|NCT02377427|Primary|Maximum Plasma Concentration (Cmax) of Mepolizumab for Part A|PK of mepolizumab was evaluated in participants using Cmax. PK samples were collected at pre-dose on Weeks 4 and 8; and at Weeks 9, 12, 16 and 20 post-dose. Cmax was evaluated by population PK methods and mean and standard error from the final model has been tabulated. Estimates have been presented from the final model centered to mean bodyweights of 27 kg, 50 kg and 70 kg. Note the average bodyweight of 70 kg (mean body weight observed in adults) was not investigated in the study. PK Population included all participants receiving at least one dose of mepolizumab beginning at Visit 2 (Week 0) and having at least one blood sample taken at Visit 3 (Week 4) or thereafter with measurable mepolizumab plasma concentration.|Pre-dose on Weeks 4 and 8; Weeks 9, 12, 16 and 20 post-dose|PK Population|||Microgram (ug) per mL||Standard Error|Mean
2582597|NCT02377362|Secondary|Change From Baseline in Hip Circumference (Part B)||Baseline to Day 28||||centimeters||Standard Deviation|Mean
2582598|NCT02377362|Secondary|Change From Baseline in Waist Circumference (Part B)||Baseline to Day 28||||centimeters||Standard Deviation|Mean
2582599|NCT02377362|Secondary|Change From Baseline in Weight (Part B)||Baseline to Day 28||||kilograms (kg)||Standard Deviation|Mean
2582600|NCT02377362|Secondary|Fasting Glucose Concentration (Part B)|Fasting glucose concentration after 28 day treatment|Baseline to Day 28||||mmol/L||Standard Deviation|Mean
2582601|NCT02377362|Secondary|Change From Baseline in Insulin Concentration (Part B)|4.5 hours following Mixed Meal Tolerance Test (MMTT) on Day 28; Baseline Adjusted. The day 28 values were used for analysis; change from baseline was calculated on Day 28.|Day 28||||uU/mL||Standard Deviation|Mean
2582602|NCT02377362|Secondary|Change From Baseline in C-Peptide Concentration (Part B)|Mixed Meal Tolerance Test (4.5 hours after a meal on Day 28); Baseline-Adjusted. The day 28 values were used for analysis; change from baseline was calculated on Day 28.|Day 28||||ng/mL||Standard Deviation|Mean
2582603|NCT02377362|Secondary|Change From Baseline in Postprandial Glucose (Part B)|Mixed Meal Tolerance Test (4.5 hours after a meal on Day 28); Baseline Adjusted. The day 28 values were used for analysis; change from baseline was calculated on Day 28.|Day 28||||mg/dL||Standard Deviation|Mean
2582604|NCT02377362|Secondary|Change From Baseline in Average Plasma Glucose Concentration After Multiple Doses (Part B)||Baseline to Day 24-26|The 450 mg twice a day arm had no usable continuous glucose data, due to technical difficulties|||mg/dL||Standard Deviation|Mean
2582605|NCT02377362|Secondary|Fraction of Drug Excreted in the Urine (Fe) (Part B)||Pre-Dose and 24-hours Post-Dose on Day 28||||percentage of the drug||Standard Deviation|Mean
2582606|NCT02377362|Secondary|Fraction of Drug Excreted in the Urine (Fe) (Part A)||Pre-Dose and 24-hours Post-Dose||||percentage of the drug||Standard Deviation|Mean
2582607|NCT02377362|Secondary|Amount of Drug Excreted in Urine (Aet0-24) (Part B)||Pre-Dose and 24-hours Post-Dose on Day 28||||mg||Standard Deviation|Mean
2582608|NCT02377362|Secondary|Amount of Drug Excreted in Urine (Aet0-24) (Part A)||Pre-Dose and 24-hours Post-Dose||||mg||Standard Deviation|Mean
2582609|NCT02377362|Secondary|Amount of Drug Excreted in Urine (Aet1-t12) (Part B)|Data Not Collected for this Parameter|Pre-Dose and 12 hours Post-Dose on Day 28|Data were not collected||||||
2582610|NCT02377362|Secondary|Amount of Drug Excreted in Urine (Aet1-t12) (Part A)|Data Not Collected for this Parameter|Pre-Dose and 12 hours Post-Dose|Data were not collected||||||
2582611|NCT02377362|Secondary|Apparent Total Volume of Distribution (VZ/F) (Part B)||Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28||||L||Standard Deviation|Mean
2582612|NCT02377362|Secondary|Apparent Total Volume of Distribution (VZ/F) (Part A)||Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose||||L||Standard Deviation|Mean
2582613|NCT02377362|Secondary|Apparent Clearance of Drug (CL/F) (Part B)||Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28||||L/hr||Standard Deviation|Mean
2582614|NCT02377362|Secondary|Apparent Clearance of Drug (CL/F) (Part A)||Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose||||L/hr||Standard Deviation|Mean
2582615|NCT02377362|Secondary|Elimination Half-Life (T1/2) (Part B)||Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28||||hours||Geometric Coefficient of Variation|Geometric Mean
2582616|NCT02377362|Secondary|Elimination Half-Life (T1/2) (Part A)||Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose||||hours||Geometric Coefficient of Variation|Geometric Mean
2582617|NCT02377362|Secondary|Time to Observed Cmax (Tmax) (Part B)||Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28||||hours||Full Range|Median
2582618|NCT02377362|Secondary|Time to Observed Cmax (Tmax) (Part A)||Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose||||hours||Full Range|Median
2582619|NCT02377362|Secondary|Maximum Observed Drug Concentration (Cmax) (Part B)||Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting on Day 28||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2582620|NCT02377362|Secondary|Maximum Observed Drug Concentration (Cmax) (Part A)||Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose||||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2582621|NCT02377362|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) (Part B)||Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24, 48, 168, and 336 hours post dose starting Day 1||||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2582622|NCT02377362|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) (Part A)||Pre-dose, 0.5, 1, 2, 4.5, 6, 8.5, 12.5, 24, 28.5, 48, 96 and 144 hours post-dose||||µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2582623|NCT02377362|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24-hour Post-Dose (AUC0-24) (Parts B)||Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24 hours post dose starting on Day 28||||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2582624|NCT02377362|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24-hour Post-Dose (AUC0-24) (Part A)||Predose, 0.5, 1, 2, 4.5, 6, 8.5, 12, 13, 14, 16, 24 hours post-dose||||µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2582629|NCT02377349|Secondary|Percentage of Household Contacts With SAEs|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.|During the 31-day (Days 0-30) follow-up period post-vaccination (Boostrix administered preferably 2 weeks before the birth of the infant, Visit 3).|This analysis was done on the Total cohort for household contacts which included all eligible household contacts of the infants born to pregnant women vaccinated in Spain. For the analysis of safety, all vaccinated household contacts are considered.|||Percentage of subjects|||Number
2582630|NCT02377349|Secondary|Percentage of Household Contacts of the Infants Born to Pregnant Women Vaccinated in Spain|This analysis assessed the vaccination status of the household contacts (who accepted, received or refused vaccination) and also the reasons for refusal (not coming to site, refused to be vaccinated, unspecified) as part of an assessment of cocooning among the eligible household contacts.|From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study).|This analysis was done on the Total cohort for household contacts in Spain, which included all eligible household contacts of the infants born to pregnant women vaccinated in Spain.|||Percentage of household contacts||95% Confidence Interval|Number
2582631|NCT02377349|Secondary|Number of Subjects With Serious AEs (SAEs)|A SAE was any untoward medical occurrence that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study).|The analysis was done on the TVC, which included all subjects with the study vaccine administration documented.|||Participants|||Count of Participants
2582632|NCT02377349|Secondary|Percentage of Infants With Unsolicited AEs|An unsolicited AE was any AE that was not solicited using a subject diary and that was spontaneously communicated by the subject. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|From delivery to Month 2 post delivery (Visit 4, end of the study).|The analysis was done on the TVC of Mother, which included all subjects with the study vaccine administration documented and who had returned their diary cards.|||Percentage of subjects||95% Confidence Interval|Number
2582633|NCT02377349|Secondary|Percentage of Subjects With Unsolicited AEs|An unsolicited AE was any AE that was not solicited using a subject diary and that was spontaneously communicated by the subject. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Dose 1 = pregnancy dose at Day 0 - Visit 1, Dose 2 = post-delivery dose at birth - Visit 3.|Within 31 days (Day 0 - Day 30) after each vaccination|The analysis was done on the TVC, which included all subjects with the study vaccine administration documented and who had returned their diary cards.|||Percentage of subjects||95% Confidence Interval|Number
2582634|NCT02377349|Secondary|Percentage of Subjects With Solicited General AEs|"Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache and fever [defined as oral, axillary or tympanic temperature ≥ 37.5 degrees Celsius (°C) or rectal temperature ≥ 38.0 °C]. Any = any report of the specified symptom irrespective of intensity grade. Dose 1 = pregnancy dose at Day 0 - Visit 1, Dose 2 = post-delivery dose at birth - Visit 3."|During the 8-day (Day 0-Day 7) follow-up period after vaccination during pregnancy|The analysis was done on the TVC, which included all subjects with the study vaccine administration documented and who had returned their diary cards.|||Percentage of subjects||95% Confidence Interval|Number
2582635|NCT02377349|Secondary|Percentage of Subjects With Solicited Local Adverse Events (AEs)|"Assessed solicited local symptoms were pain, redness and swelling. Any = any report of the specified symptom irrespective of intensity grade. Dose 1 = pregnancy dose at Day 0 - Visit 1, Dose 2 = post-delivery dose at birth - Visit 3."|During the 8-day (Day 0-Day 7) follow-up period after vaccination during pregnancy|The analysis was done on the TVC, which included all subjects with the study vaccine administration documented and who had returned their diary cards.|||Percentage of subjects||95% Confidence Interval|Number
2582636|NCT02377349|Secondary|Percentage of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN in the Cord Blood Samples|For this assay the anti-PT, anti-FHA and anti-PRN seropositivity status was determined from the cord blood samples. The seropositivity cut-offs were the following: 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN.|At delivery - Visit 3 (anytime after 27 eligible weeks of gestation)|The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration, who had cord blood collected at least 21 days post-vaccination and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 3 were available.|||Percentage of subjects||95% Confidence Interval|Number
2582637|NCT02377349|Secondary|Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN|Vaccine response to PT, FHA and PRN antigens is defined as: for subjects with pre-vaccination antibody concentration below the assay cut-off (S-), post-vaccination anti-body concentration ≥ 4 times the assay cut-off; for subjects with pre-vaccination antibody concentration between the assay cut-off and below 4 times the assay cut-off (S+), post-vaccination antibody concentration ≥ 4 times the pre-vaccination antibody concentration, and for subjects with pre-vaccination antibody concentration ≥4 times the assay cut-off (S+), post-vaccination antibody concentration ≥2 times the pre-vaccination antibody concentration.|One month post vaccination (Day 30) during pregnancy|The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 2 were available.|||Percentage of subjects||95% Confidence Interval|Number
2582638|NCT02377349|Secondary|Percentage of Subjects With Vaccine Response to Anti-D and Anti-T|"Vaccine response for anti-D and anti-T was defined as:~for initially seronegative subjects (S-) with pre-vaccination concentration below cut-off: < 0.1 IU/mL) was an antibody concentration at least four times the assay cut-off (post-vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (S+) with pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration."|One month post vaccination (Day 30) during pregnancy|The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 2 were available.|||Percentage of subjects||95% Confidence Interval|Number
2582640|NCT02377349|Secondary|Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN|A seroprotected subject against diphteria and tetanus was a subject with antibody concentration ≥ 0.1 IU/mL. A seropositive subject was a subjects with antibody concentration ≥ 2.693 IU/mL for anti-PT, ≥ 2.046 IU/mL for anti-FHA and ≥ 2.187 IU/mL for anti-PRN.|One month post vaccination (Day 30) during pregnancy|The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 2 were available.|||Percentage of subjects||95% Confidence Interval|Number
2582641|NCT02377349|Secondary|Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest|Listed pregnancy-related adverse events of interest/ neonate-related events of interest included gestational diabetes, pregnancy-related hypertension, premature rupture of mem-branes, preterm premature rupture of membranes, premature labour, premature uterine contractions, intrauterine growth restriction/poor foetal growth, pre-eclampsia, eclampsia, vaginal or intrauterine haemorrhage, maternal death, preterm birth, neonatal death, small for gestational age, neonatal hypoxic ischaemic encephalopathy and failure to thrive/growth deficiency were reported.|From Day 0 (Visit 1) to Month 2 post-delivery (Visit 4, end of the study).|This analysis was performed on the TVC which included all subjects with the study vaccine administration documented.|||Percentage of subjects||95% Confidence Interval|Number
2582642|NCT02377349|Secondary|Percentage of Subjects by Pregnancy Outcomes|Pregnancy outcomes included live birth with no congenital anomalies, live birth with congenital anomalies, still birth with no congenital anomalies, still birth with congenital anomalies, elective termination with no congenital anomalies and elective termination with congenital anomalies. No subjects with still birth or elective termination of infant were reported.|From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study).|This analysis was performed on the Total Vaccinated cohort (TVC) which included all subjects with the study vaccine administration documented.|||Percentage of subjects||95% Confidence Interval|Number
2582643|NCT02377349|Primary|Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood Samples|Antibody concentrations were assessed by Enzyme-linked immunosorbent assay (ELISA), tabulated as Geometric Mean Concentrations (GMCs) and expressed in International units per mililiter (IU/mL) for the following assay cut-offs: 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN.|At delivery - Visit 3 (anytime after 28 weeks of gestation)|The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration, who had cord blood collected at least 21 days post-vaccination and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 3 were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2582644|NCT02377063|Primary|Change in Colonic Flora Composition|Changes in microbial count (%) were calculated as the values at day 4 minus the values at baseline|baseline and day 4|All participants for whom colonic flora composition were measured at baseline and day 4.|||percentage of total bacteria||Standard Error|Mean
2582645|NCT02376998|Primary|Number of Participants With Major Adverse Events|Evaluation of mortality, renal failure, cerebrovascular accident.|from hospital discharge to 1 month after the procedure|No serious adverse events recorded|||number of serious adverse events|||Number
2582646|NCT02376933|Secondary|Fracture Rates Detected From X-rays.||14 weeks|Study terminated when PI left institution; data not collected.||||||
2582647|NCT02376933|Secondary|Quality of Life Assessment From the EORTC QLQ C30 Questionnaire.|"EORTC QLQ-C30 (version 3) - The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.~Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.~Thus a high score for a functional scale represents a high / healthy level of functioning,a high score for the global health status / QoL represents a high QoL,but a high score for a symptom scale / item represents a high level of symptomatology / problems."|14 weeks|Study terminated when PI left institution; data not collected.||||||
2582648|NCT02376933|Secondary|Activity Level Assessment From the Roland Morris Questionnaire (RDQ) and Karnofsky Performance Status (KPS)|"Roland-Morris Disability Questionnaire - The score of the RDQ is the total number of items checked - i.e. from a minimum of 0 (best) to a maximum of 24 (worst).~Karnofsky Performance Status (KPS) - scale from 10 (moribund, fatal processes progressing rapidly) to 100 (normal, no complaints, no evidence of disease)."|14 weeks|Study terminated when PI left institution; data not collected.||||||
2582649|NCT02376933|Primary|Pain Assessment From the Worst Pain Score on Brief Pain Inventory as Compared to Historical Radiation Therapy Oncology Group (RTOG) 9714 Study.|"Assessment of the patient's pain, activities and quality of life will be gathered from the patient in returning for follow-up or by contacting the patient by phone approximately 1 week following the completion of their first procedure, whether it be the vertebral augmentation or the radiotherapy (5 - 10 days following). Mandatory assessments include:~- Worst Pain Score - Brief Pain Inventory (BPI) - The Worst Pain Assessment on the Brief Inventory Scale is an assessment tool of current pain intensity and pain intensity within the last 24 hours when not on pain control medications. 0 being no pain and 10 is the worst pain possible. See protocol attachments"|14 weeks|Study terminated when PI left institution; data not collected.||||||
2582650|NCT02376790|Secondary|Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups|"The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5:~0 = clear (no evidence of plaque elevation, erythema or scaling)~= almost clear (minimal plaque elevation, erythema or scaling)~= mild (mild plaque elevation or scaling, light red coloration)~= moderate (moderate plaque elevation, scaling, light red coloration)~= marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration)~= severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration)."|Baseline and week 24|Randomized participants with available data|||percentage of participants|||Number
2601692|NCT02150837|Secondary|Abdominal Circumference|Abdominal circumference expressed as an absolute change from baseline.|4 weeks||||Inches||Standard Deviation|Mean
2582651|NCT02376790|Secondary|Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline at Week 24|"The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5:~0 = clear (no evidence of plaque elevation, erythema or scaling)~= almost clear (minimal plaque elevation, erythema or scaling)~= mild (mild plaque elevation or scaling, light red coloration)~= moderate (moderate plaque elevation, scaling, light red coloration)~= marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration)~= severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration)."|Baseline and week 24|Randomized participants with ≥ 3% body surface area (BSA) psoriasis involvement at baseline and available sPGA data.|||percentage of participants|||Number
2582652|NCT02376790|Secondary|Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups|"The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5:~0 = clear (no evidence of plaque elevation, erythema or scaling)~= almost clear (minimal plaque elevation, erythema or scaling)~= mild (mild plaque elevation or scaling, light red coloration)~= moderate (moderate plaque elevation, scaling, light red coloration)~= marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration)~= severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration)."|Baseline and week 24|Randomized participants with available data|||percentage of participants|||Number
2582653|NCT02376790|Secondary|Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24|"The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5:~0 = clear (no evidence of plaque elevation, erythema or scaling)~= almost clear (minimal plaque elevation, erythema or scaling)~= mild (mild plaque elevation or scaling, light red coloration)~= moderate (moderate plaque elevation, scaling, light red coloration)~= marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration)~= severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration)."|Baseline and week 24|Randomized participants with ≥ 3% body surface area (BSA) psoriasis involvement at baseline and available sPGA data.|||percentage of participants|||Number
2582654|NCT02376790|Secondary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24 by Baseline BSA Involvement Subgroups|"The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5:~0 = clear (no evidence of plaque elevation, erythema or scaling)~= almost clear (minimal plaque elevation, erythema or scaling)~= mild (mild plaque elevation or scaling, light red coloration)~= moderate (moderate plaque elevation, scaling, light red coloration)~= marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration)~= severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration)."|Week 24|Randomized participants with available data|||percentage of participants|||Number
2582655|NCT02376790|Secondary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24|"The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5:~0 = clear (no evidence of plaque elevation, erythema or scaling)~= almost clear (minimal plaque elevation, erythema or scaling)~= mild (mild plaque elevation or scaling, light red coloration)~= moderate (moderate plaque elevation, scaling, light red coloration)~= marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration)~= severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration)."|Week 24|Randomized participants with ≥ 3% body surface area (BSA) psoriasis involvement at baseline and available sPGA data.|||percentage of participants|||Number
2582656|NCT02376790|Secondary|Mean Static Physician Global Assessment (sPGA) Score at Week 24 by Baseline BSA Involvement Subgroups|"The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5:~0 = clear (no evidence of plaque elevation, erythema or scaling)~= almost clear (minimal plaque elevation, erythema or scaling)~= mild (mild plaque elevation or scaling, light red coloration)~= moderate (moderate plaque elevation, scaling, light red coloration)~= marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration)~= severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration)."|Week 24|Randomized participants with available data|||units on a scale||Standard Error|Mean
2582657|NCT02376790|Secondary|Mean Static Physician Global Assessment (sPGA) Score at Week 24|"The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5:~0 = clear (no evidence of plaque elevation, erythema or scaling)~= almost clear (minimal plaque elevation, erythema or scaling)~= mild (mild plaque elevation or scaling, light red coloration)~= moderate (moderate plaque elevation, scaling, light red coloration)~= marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration)~= severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration)."|Week 24|Randomized participants with ≥ 3% body surface area (BSA) psoriasis involvement at baseline and available sPGA data.|||units on a scale||Standard Error|Mean
2582658|NCT02376790|Secondary|Static Physician Global Assessment (sPGA) at Week 24 by Baseline BSA Involvement Subgroups|"The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5:~0 = clear (no evidence of plaque elevation, erythema or scaling)~= almost clear (minimal plaque elevation, erythema or scaling)~= mild (mild plaque elevation or scaling, light red coloration)~= moderate (moderate plaque elevation, scaling, light red coloration)~= marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration)~= severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration)."|Week 24|Randomized participants with available data|||Participants|||Count of Participants
2601693|NCT02150837|Secondary|Fat Mass|Fat mass expressed as an absolute change from baseline.|20 weeks||||Pounds||Standard Deviation|Mean
2582659|NCT02376790|Secondary|Static Physician Global Assessment (sPGA) at Week 24|"The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5:~0 = clear (no evidence of plaque elevation, erythema or scaling)~= almost clear (minimal plaque elevation, erythema or scaling)~= mild (mild plaque elevation or scaling, light red coloration)~= moderate (moderate plaque elevation, scaling, light red coloration)~= marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration)~= severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration)."|Week 24|Randomized participants with ≥ 3% body surface area (BSA) psoriasis involvement at baseline and available sPGA data.|||Participants|||Count of Participants
2582660|NCT02376790|Secondary|Percent Improvement From Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis by Baseline BSA Involvement Subgroups|"The physician's assessment of the percentage of the participant's total body surface area involved with psoriasis.~Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline * 100"|Baseline and week 24|Randomized participants with available BSA data|||percent change||Standard Error|Mean
2582661|NCT02376790|Secondary|Percent Improvement From Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis at Week 24|"The physician's assessment of the percentage of the participant's total body surface area involved with psoriasis.~Percent improvement from baseline = (Baseline Value - Post-baseline Value) / Baseline * 100"|Baseline and week 24|Randomized participants with ≥ 3% body surface area (BSA) psoriasis involvement at baseline and available data.|||percent change||Standard Error|Mean
2582662|NCT02376790|Secondary|Percentage of Participants With Clear SPARCC Enthesitis Index Score at Week 24|"The SPARCC enthesitis index assesses enthesitis at 18 sites for palpitation with a resultant total score of 0 to 16 (for scoring purposes, the inferior patella and tibial tuberosity are considered 1 site because of their anatomical proximity). Tenderness at each site is quantified on a dichotomous basis (0 = non-tender, 1 = tender). Entheses assessed are medial epicondyle (left and right), lateral epicondyle (left and right), supraspinatus insertion into greater tuberosity of humerus (left and right), greater trochanter (left and right), quadriceps insertion into superior border of patella (left and right), patellar ligament insertion into inferior pole of patella or tibial tubercle (left and right), Achilles tendon insertion into calcaneum (left and right), plantar fascia insertion into calcaneum (left and right). A higher count represents greater enthesitis burden.~Clear SPARCC enthesitis is defined as a score = 0."|Baseline and week 24|Randomized participants with non-zero SPARCC enthesitis index score at baseline and available data at week 24|||percentage of participants|||Number
2582663|NCT02376790|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Week 24|The SPARCC enthesitis index assesses enthesitis at 18 sites for palpitation with a resultant total score of 0 to 16 (for scoring purposes, the inferior patella and tibial tuberosity are considered 1 site because of their anatomical proximity). Tenderness at each site is quantified on a dichotomous basis (0 = non-tender, 1 = tender). Entheses assessed are medial epicondyle (left and right), lateral epicondyle (left and right), supraspinatus insertion into greater tuberosity of humerus (left and right), greater trochanter (left and right), quadriceps insertion into superior border of patella (left and right), patellar ligament insertion into inferior pole of patella or tibial tubercle (left and right), Achilles tendon insertion into calcaneum (left and right), plantar fascia insertion into calcaneum (left and right). A higher count represents greater enthesitis burden.|Baseline and week 24|Randomized participants with non-zero SPARCC enthesitis index score at baseline and available data at week 24|||units on a scale||Standard Error|Mean
2582664|NCT02376790|Secondary|Percentage of Participants With Clear LDI at Week 24|"The Leeds dactylitis index quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with a 10% difference in the ratio of circumference of the affected digit to the contralateral digit. The control digit is either the contralateral digit (digit on opposite hand or foot), or if the contralateral digit is also affected, values from a standard reference table. Tenderness of affected digits is assessed on a scale from 0 [none] to 3 [worst]. The ratio of circumference between an affected digit and the control digit is multiplied by the tenderness score for the affected digit. The results from each involved digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis.~Clear LDI is defined as a score = 0."|Baseline and week 24|Randomized participants with non-zero LDI score at baseline and available data at week 24|||percentage of participants|||Number
2582665|NCT02376790|Secondary|Change From Baseline in Leeds Dactylitis Index (LDI) at Week 24|The Leeds dactylitis index quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with a 10% difference in the ratio of circumference of the affected digit to the contralateral digit. The control digit is either the contralateral digit (digit on opposite hand or foot), or if the contralateral digit is also affected, values from a standard reference table. Tenderness of affected digits is assessed on a scale from 0 [none] to 3 [worst]. The ratio of circumference between an affected digit and the control digit is multiplied by the tenderness score for the affected digit. The results from each involved digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis.|Baseline and week 24|Randomized participants with non-zero LDI score at baseline and available data at week 24|||units on a scale||Standard Error|Mean
2582666|NCT02376790|Secondary|Percentage of Participants With Clear mNAPSI at Week 24|"The modified NAPSI scale is a grading system for nail psoriasis that incorporates the following 7 clinical features:~pitting (scores 0-3, depending on the number of pits)~nail plate crumbling (scores 0-3, depending on the % of nail involvement)~onycholysis and oil drop dyschromia (scores 0-3, depending on the % of nail involvement)~leukonychia (0 = absent, 1 = present)~red spots in lunula (0 = absent, 1 = present)~nail bed hyperkeratosis (0 = absent, 1 = present)~splinter hemorrhages (0 = absent, 1 = present)~In participants with fingernails involved with psoriasis, each fingernail was scored at baseline to determine the worst fingernail (ie, the fingernail with the highest mNAPSI score). This fingernail was followed for the remainder of the study.~mNAPSI scores range from 0-13 where higher scores represent worse nail disease. Clear mNAPSI is defined as a score = 0."|Baseline and week 24|Randomized participants with non-zero mNAPSI score at baseline and available data at week 24|||percentage of participants|||Number
2601694|NCT02150837|Secondary|Fat Mass|Fat mass expressed as an absolute change from baseline.|16 weeks||||Pounds||Standard Deviation|Mean
2582667|NCT02376790|Secondary|Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Week 24|"The modified NAPSI scale is a grading system for nail psoriasis that incorporates the following 7 clinical features:~pitting (scores 0-3, depending on the number of pits)~nail plate crumbling (scores 0-3, depending on the % of nail involvement)~onycholysis and oil drop dyschromia (scores 0-3, depending on the % of nail involvement)~leukonychia (0 = absent, 1 = present)~red spots in lunula (0 = absent, 1 = present)~nail bed hyperkeratosis (0 = absent, 1 = present)~splinter hemorrhages (0 = absent, 1 = present)~In participants with fingernails involved with psoriasis, each fingernail was scored at baseline to determine the worst fingernail (ie, the fingernail with the highest mNAPSI score). This fingernail was followed for the remainder of the study.~mNAPSI scores range from 0-13 where higher scores represent worse nail disease."|Baseline and week 24|Randomized participants with non-zero mNAPSI score at baseline and available data at week 24|||units on a scale||Standard Error|Mean
2582668|NCT02376790|Secondary|Change From Baseline in Medical Outcomes Health Survey Short Form 36 Items Version 2 (SF-36 v2) at Week 24|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains. Two summary component scores are calculated: mental component summary score (MCS) and physical component summary score (PCS). The MCS consists of social functioning, vitality, mental health, and role-emotional scales and the PCS consists of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.|Baseline and week 24|All randomized participants with available data|||units on a scale||Standard Error|Mean
2582669|NCT02376790|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring in 8 functional areas: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and week 24|All randomized participants with available data|||units on a scale||Standard Error|Mean
2582670|NCT02376790|Secondary|Change From Baseline in the Disease Activity Score 28 (DAS28) Over Time|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count~C-reactive protein (CRP)~Patient's global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest.~DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission."|Baseline and weeks 4, 8, 12, 16, 24, 36, and 48|All randomized participants with non-missing data at each time point|||units on a scale||Standard Error|Mean
2582671|NCT02376790|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Over Time|"The Simplified Disease Activity Index (SDAI) is a composite index that is calculated as the sum of the following items:~28 tender joint count,~28 swollen joint count,~Patient's Global Assessment of Disease Activity measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.~CRP~The SDAI score ranges from 0 to 86 with higher scores representing worse disease."|Baseline and weeks 4, 8, 12, 16, 24, 36, and 48|All randomized participants with non-missing data at each time point|||units on a scale||Standard Error|Mean
2582672|NCT02376790|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time|"The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the following items:~28 tender joint count,~28 swollen joint count,~Patient's Global Assessment of Disease Activity measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest;~Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest.~The CDAI score ranges from 0-76 where lower scores indicate less disease activity."|Baseline and weeks 4, 8, 12, 16, 24, 36, and 48|All randomized participants with non-missing data at each time point|||units on a scale||Standard Error|Mean
2582673|NCT02376790|Secondary|Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Over Time|"PASDAS is a measure of disease activity derived from the following variables:~Physician and patient global assessment of disease activity (assessed on a 0-100 VAS)~68 tender joint count~66 swollen joint count~Short Form-36 Questionnaire (SF-36) physical component summary (general health status on a scale from 0-100)~Tender dactylitis count (each digit assessed for tender dactylitis; total score 0-20)~Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6)~CRP level (mg/L)~The composite score is a weighted index where higher scores indicate more severe disease."|Baseline and weeks 12, 24, 36, and 48|All randomized participants with non-missing data at each time point|||units on a scale||Standard Error|Mean
2582674|NCT02376790|Secondary|Percentage of Participants With a American Minimal Disease Activity (MDA) Response Over Time|"Minimal Disease Activity (MDA) is a measure of low disease activity specific for psoriatic arthritis (PsA) that incorporates measures of joint and entheseal inflammation, skin disease, patient reported outcomes and functional disability to assess disease activity. Participants were classified as achieving MDA if they fulfilled 5 of the following 7 outcome measures:~Tender joint count (0-68) ≤ 1~Swollen joint count (0-66) ≤ 1~Body surface area (BSA) involvement with psoriasis (0% to 100%) ≤ 3%~Patient global assessment of joint pain VAS (0-100) ≤ 15~Patient global assessment of disease activity VAS (0-100) ≤ 20~HAQ-DI (0-3) ≤ 0.5~Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index (18 sites assessed for enthesitis with an overall score of 0 - 16) ≤ 1"|Weeks 4, 8, 12, 24, 36, and 48|All randomized participants with non-missing data at each time point|||percentage of participants|||Number
2582675|NCT02376790|Secondary|Change From Baseline in C-reactive Protein Concentration Over Time|C-reactive protein (CRP) is a specific measure of inflammatory activity.|Baseline and weeks 4, 8, 12, 16, 24, 36, and 48|All randomized participants with non-missing data at each time point|||mg/L||Standard Error|Mean
2601695|NCT02150837|Secondary|Fat Mass|Fat mass expressed as an absolute change from baseline.|8 weeks||||Pounds||Standard Deviation|Mean
2582676|NCT02376790|Secondary|Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Over Time|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.|Baseline and weeks 4, 8, 12, 16, 24, 36, and 48|All randomized participants with non-missing data at each time point|||units on a scale||Standard Error|Mean
2582677|NCT02376790|Secondary|Change From Baseline in Patient Global Assessment of Joint Pain Over Time|A global assessment of the severity of the participant's joint pain, assessed by the participant on a 100 mm VAS where 0 mm = No pain at all and 100 mm = Worst pain imaginable.|Baseline and weeks 4, 8, 12, 16, 24, 36, and 48|All randomized participants with non-missing data at each time point|||mm||Standard Error|Mean
2582678|NCT02376790|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity Over Time|A global assessment of the participant's arthritis, assessed by the participant on a 100 mm VAS where 0 mm = No arthritis activity at all and 100 mm = Worst arthritis activity imaginable.|Baseline and weeks 4, 8, 12, 16, 24, 36, and 48|All randomized participants with non-missing data at each time point|||mm||Standard Error|Mean
2582679|NCT02376790|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity Over Time|A global assessment of the participant's arthritis assessed by the physician on a 100 mm visual analog scale (VAS) where 0 mm = No activity at all and 100 mm = Worst activity imaginable.|Baseline and weeks 4, 8, 12, 16, 24, 36, and 48|All randomized participants with non-missing data at each time point|||mm||Standard Error|Mean
2582680|NCT02376790|Secondary|Change From Baseline in Swollen Joint Count Over Time|The swollen joint count is an assessment of the swelling of 66 joints using a 0 to 1 point scale (0 = none, 1 = present). The total swollen joint count is calculated by summing the number of joints with present swelling.|Baseline and weeks 4, 8, 12, 16, 24, 36, and 48|All randomized participants with non-missing data at each time point|||swollen joints||Standard Error|Mean
2582681|NCT02376790|Secondary|Change From Baseline in Tender Joint Count Over Time|The tender joint count is an assessment of the pain and/or tenderness of 68 joints using a 0 to 1 point scale (0 = none, 1 = present). The total tender joint count is calculated by summing the number of joints with present tenderness.|Baseline and weeks 4, 8, 12, 16, 24, 36, and 48|All randomized participants with non-missing data at each time point|||tender joints||Standard Error|Mean
2582682|NCT02376790|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time|"A positive ACR70 response is defined if the following 3 criteria for improvement from baseline were met:~≥ 70% improvement in 68 tender joint count;~≥ 70% improvement in 66 swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of joint pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein."|Baseline and weeks 4, 8, 12, 16, 24, 36, and 48|All randomized participants with non-missing data at each time point.|||percentage of participants|||Number
2582683|NCT02376790|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time|"A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met:~≥ 50% improvement in 68 tender joint count;~≥ 50% improvement in 66 swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of joint pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein."|Baseline and weeks 4, 8, 12, 16, 24, 36, and 48|All randomized participants with non-missing data at each time point|||percentage of participants|||Number
2582684|NCT02376790|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time|"A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of joint pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein."|Baseline and weeks 4, 8, 12, 16, 24, 36, and 48|All randomized participants with non-missing data at each time point.|||percentage of participants|||Number
2582685|NCT02376790|Secondary|Percentage of Participants With a Minimal Disease Activity (MDA) Response at Week 24|"Minimal Disease Activity (MDA) is a measure of low disease activity specific for psoriatic arthritis (PsA) that incorporates measures of joint and entheseal inflammation, skin disease, patient reported outcomes and functional disability to assess disease activity. Participants were classified as achieving MDA if they fulfilled 5 of the following 7 outcome measures:~Tender joint count (0-68) ≤ 1~Swollen joint count (0-66) ≤ 1~Body surface area (BSA) involvement with psoriasis (0% to 100%) ≤ 3%~Patient global assessment of joint pain VAS (0-100) ≤ 15~Patient global assessment of disease activity VAS (0-100) ≤ 20~HAQ-DI (0-3) ≤ 0.5~Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index (18 sites assessed for enthesitis with an overall score of 0 - 16) ≤ 1"|Week 24|All randomized participants; missing postbaseline data were imputed using non-responder imputation.|||percentage of participants|||Number
2582702|NCT02376166|Secondary|Episodes of Bloating|Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 4th reported outcome - Number of episodes of bloating|6 months||||episodes|||Number
2582703|NCT02376166|Secondary|Episodes of Flatulence|Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 3rd reported outcome - Number of episodes of flatulence|6 months||||episodes|||Number
2601696|NCT02150837|Secondary|Fat Mass|Fat mass expressed as an absolute change from baseline.|4 weeks||||Pounds||Standard Deviation|Mean
2582686|NCT02376790|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24|"A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met:~≥ 20% improvement in 68 tender joint count;~≥ 20% improvement in 66 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of joint pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a 100 mm VAS);~Physician's global assessment of disease activity (measured on a 100 mm VAS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-reactive protein concentration."|Baseline and week 24|All randomized participants; missing postbaseline data were imputed using non-responder imputation.|||percentage of participants|||Number
2582687|NCT02376530|Primary|Nutritional Quality of Food Purchases|The Overall Nutrient Quality Index (ONQI) was used to assess nutritional quality of foods purchased. The ONQI is a 1 - 100 scale in which higher numbers indicate higher nutritional quality. Each food is given a score based on a ratio with positive health nutrients in the numerator and detrimental health nutrients in the denominator, based on a proprietary algorithm created by NuVal. The average ONQI score for all the groceries purchases was used as the outcome measure, of ONQI scores on a scale.|Participants were followed for one shopping session, an average of 2.5 hours|Data was analyzed for 781 participants. Two participants did not understand the study, 2 participants had incorrect price manipulations during their session, 1 participant was ill during the session, 1 participant had her young daughter in the room during the experiment and 1 participant did not have a household to shop for.|||Average NUVAL Score||Standard Deviation|Least Squares Mean
2582688|NCT02376283|Secondary|Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by VASP (Vasodilator Stimulated Phosphoprotein Phosphorylation) Flow Cytometry and Expressed as %PRI (Platelet Reactivity Index)||Balloon Inflation as Baseline, 20, 60, 240 minutes|The overall group consists of STEMI and NSTEMI participants -outcome measure is broken down into the time points for each specific sub-group reported separately by Row. These two categories represent a subpopulation within the Overall Number of Participants Analyzed, therefore it has been indicated how many participants were analyzed for each Row.|||%PRI||Standard Deviation|Mean
2582689|NCT02376283|Primary|Pharmacokinetic Quantification of Plasma Concentration of Clopidogrel and Prasugrel Active Metabolite and Ticagrelor Parent Compound and Active Metabolite Assessed Using Liquid Chromatography in Tandem With Mass Spectrometry (LC-MS/MS) Expressed as ng/ml|The parent compound of Ticagrelor was also analysed within the same patient group of Ticagrelor as it is a directly acting agent that does not require metabolic conversion to its active form.|Balloon Inflation as Baseline, 20, 60, 240 minutes|The overall group consists of STEMI and NSTEMI participants -outcome measure is broken down into the time points for each specific sub-group reported separately by Row. These two categories represent a subpopulation within the Overall Number of Participants Analyzed, therefore it has been indicated how many participants were analyzed for each Row.|||ng/ml||Standard Error|Mean
2582690|NCT02376283|Primary|Pharmacodynamic Assessment of Degree of Platelet Inhibition as Determined by Verify Now Point of Care Assay and Expressed as P2Y12 Reaction Units (PRU)||Balloon Inflation as Baseline, 20, 60, 240 minutes|The overall group consists of STEMI and NSTEMI participants -outcome measure is broken down into the time points for each specific sub-group reported separately by Row. These two categories represent a subpopulation within the Overall Number of Participants Analyzed, therefore it has been indicated how many participants were analyzed for each Row.|||P2Y12 reaction units (PRU)||Standard Deviation|Mean
2582691|NCT02376257|Secondary|Digits Backward|The examiner reads a list of digits and asks that each digit be read backwards. The score is the total number of trials completed correctly; scores range from 0 to 16. Higher scores indicate better performance.|Baseline, Week 1, Week 2, Week 3|Data is missing for two participants.|||Number of correct trials||Standard Deviation|Mean
2582692|NCT02376257|Secondary|Skills of Cognitive Therapy|This measure assesses the self-reported use of skills from cognitive therapy. Scores can range from 8 to 40, and higher scores indicate greater use.|Week 2 and Week 3|Data is missing for one participant.|||units on a scale||Standard Deviation|Mean
2582693|NCT02376257|Secondary|Immediate Recall of Emotional Story Items|Immediate recall score of items from the Emotional Story presentation. Scores can range from 0 to 74, with higher scores reflect greater memory for story items.|Week 1, Week 2, Week 3||||Number of story units recalled||Standard Deviation|Mean
2582694|NCT02376257|Secondary|Immediate Memory Measured by the Hopkins Verbal Learning Task|The Hopkins Verbal Learning Test (HVLT) consists of a 12-item word list, composed of four words from each of the three semantic categories. The patient's free recall of the list is recorded. The same procedure is repeated for two more trials. The total recall score for the third trial was used as the recorded score and ranged from a minimum of zero to a maximum of 12 correct answers.|Baseline, Week 1, Week 2, Week 3|Data is missing for two participants.|||Number of words recalled||Standard Deviation|Mean
2582695|NCT02376257|Secondary|Logical Memory Immediate Recall|Immediate Story Recall from the Wechsler Memory Scale Story B. Higher scores reflect greater recall of the story material from the previous week. Possible scores range from 0 to 25.|Week 1, Week 2, Week 3||||Number of story units recalled||Standard Deviation|Mean
2582696|NCT02376257|Primary|1 Week Delayed Recall Logical Memory|Higher scores reflect greater recall of Wechsler Memory Scale (WMS) Story B content assessed one week after last rehearsal. Possible scores range from 0 to 25.|Week 2 and Week 3||||units on a scale||Standard Deviation|Mean
2582697|NCT02376257|Primary|1 Week Delayed Recall of Emotional Story Items|1 Week Delayed Recall of a Threat-Related Story. Scores can range from 0 to 74, with higher scores reflect greater memory for story items.|Week 2 and Week 3||||units on a scale||Standard Deviation|Mean
2582698|NCT02376257|Primary|Recall of Cognitive Therapy Content|A modified Cognitive Therapy Awareness Scale (CTAS) was used to assess delayed memory for cognitive therapy content from the computerized CBT. Higher scores indicate better memory for CBT skills. Scores range from 0 to 40.|Week 2 and Week 3|Data was missing for two participants.|||Number of correct units of information||Standard Deviation|Mean
2582699|NCT02376179|Primary|Changes in the Intracuff Pressure|Changes in the intracuff pressure from baseline of cuffed ETT's after positioning of the patient's head and retractor placement.|during time of surgery||||cmH2O||Standard Deviation|Mean
2582700|NCT02376166|Secondary|Episodes of Vomiting|Quality of LIfe as measured by a modified RAND 36-Item Health Survey. 6th reported outcome - Number of episodes of vomiting|6 months||||episodes|||Number
2582707|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 12|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - I felt that I was able to communicate well with the study team, even though most contact was through the tablet computer video instead of in person."|6 months||||Participants|||Count of Participants
2582708|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 11|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - I would participate in a clinical trial where the entire trial was conducted remotely without requiring any visits to the study center."|6 months||||Participants|||Count of Participants
2582709|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 10|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - I would recommend participation in a telemedicine clinical trial to other patients."|6 months||||Participants|||Count of Participants
2582710|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 9|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - I felt I was monitored sufficiently closely while enrolled in this trial."|6 months||||Participants|||Count of Participants
2582711|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 8|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - My local physician was adequately informed about my participation in this trial (if applicable)."|6 months||||Participants|||Count of Participants
2582712|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 7|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - This telemedicine approach eases the financial burden of participation in clinical trials for patients."|6 months||||Participants|||Count of Participants
2582713|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 6|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - This telemedicine approach eases the travel burden for participation in clinical trials for patients."|6 months||||Participants|||Count of Participants
2582714|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 5|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - I found it easy to use the telemonitoring tablet computer."|6 months||||Participants|||Count of Participants
2582715|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 4|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - Participation in this trial did not disrupt my work or other activities."|6 months||||Participants|||Count of Participants
2582716|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 3|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - The time commitment required for participation in this trial was not overly burdensome."|6 months||||Participants|||Count of Participants
2582717|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 2|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - I would participate in a telemedicine clinical trial in the future."|6 months||||Participants|||Count of Participants
2582718|NCT02376166|Secondary|Patient Satisfaction as Measured by a Patient Satisfaction Survey Question 1|"Patient satisfaction with the remote clinical trial experience as measured by a patient satisfaction survey - I would participate in a clinical trial in the future."|6 months|2 patients did not complete the questionnaire|||Participants|||Count of Participants
2582719|NCT02376166|Secondary|Adherence With Metformin as Measured by Electronic Pill Adherence Monitoring|Adherence with metformin as measured by electronic pill adherence monitoring. Patients were provided with an electronic medication dispenser/medication adherence monitoring device. The device provided audible and visual reminders to proceed with drug dosing and was equipped with a cellular modem that registers a signal to a cloud-based database each time a patient accessed his or her study medication. However, the size and shape of the metformin pills caused the device to malfunction frequently, which led patients to access the pills from the device manually; the data, therefore, could not be used for analysis.|6 months|||||||
2582720|NCT02376166|Secondary|Percentage of Participants With Stable PSA Levels at 6 Months as Defined by a <20% Change|Percent of patients with 6-month PSA stable 20% change at 6 months as compared to baseline|baseline and 6 month||||Participants|||Count of Participants
2582721|NCT02376166|Primary|Number of Participants That Completed All Telemedicine Visits|Feasibility will be defined as completion of all telemedicine visits by > 2/3 of enrolled patients (unless treatment discontinued early for toxicity or disease progression).|6 months||||Participants|||Count of Participants
2582722|NCT02375971|Secondary|Mean Change From Baseline in Vital Signs (Sitting Blood Pressure) at Day 85 and Day 169|Blood Pressure measurements were not required by the protocol. Instead, the most recent Systolic and Diastolic Blood Pressure expressed in millimeters of mercury (mmHg) measured as part of the routine clinical care were used. Only descriptive analysis done.|Baseline, Day 85, Day 169|The Safety Set was considered. Only patients with evaluable data at each time point were analyzed for that time point.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2582723|NCT02375971|Secondary|Mean Change From Baseline in Vital Signs (Weight) at Day 85 and Day 169|Body weight was measured. Only descriptive analysis done.|Baseline, Day 85, Day 169|The Safety Set was considered. Only patients with evaluable data at each time point were analyzed for that time point.|||gram (g)||Standard Deviation|Mean
2582724|NCT02375971|Secondary|Mean Change From Baseline in Vital Signs (Body Length, Head Circumference and Knee to Heel Length) at Day 85 and Day 169|Body Length, Head Circumference and Knee to Heel Length were assessed. Only descriptive analysis done.|Baseline, Day 85, Day 169|The Safety Set was considered. Only patients with evaluable data at each time point were analyzed for that time point.|||centimeter (cm)||Standard Deviation|Mean
2582793|NCT02374138|Other Pre-specified|Parental Resilience|Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism.|Baseline||||units on a scale||Standard Deviation|Mean
2582725|NCT02375971|Secondary|Percent of Participants With Non-Ocular Adverse Events by Primary System Organ (SOCs) at Week 24|Percent of Participants with Non-Ocular Adverse Events regardless of Study Treatment and Procedure Relationship by Primary System Organ (SOCs) reported categorically (Mild, Moderate, Severe) 24 weeks after the first study treatment. Only descriptive analysis done.|Week 24|The Safety Set was considered.|||Percent of participants|||Number
2582726|NCT02375971|Secondary|Total Number of Ranibizumab Injections Received at Week 24|Patients randomized to receive Ranibizumab 0.1 mg or 0.2 mg received a single dose of intravitreal Ranibizumab to each eye on Day 1 (Baseline). Only descriptive analysis done.|Week 24|The Safety Set was considered.|||Injections|||Number
2582727|NCT02375971|Secondary|Mean Change in Vascular Endothelial Growth Factor (VEGF) Levels Over Time at Day 1, Day 15 and Day 29|Blood samples for the determination of systemic VEGF levels were collected at the following time points: before the first investigational treatment, at Day 15 and at Day 29. Only descriptive analysis done.|Day 1 (Baseline), Day 15 and Day 29|The VEGF Set, which consisted of all participants with at least one valid VEGF concentration value, was considered.|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
2582728|NCT02375971|Secondary|Mean Change in Ranibizumab Concentration in Pharmacokinetic Serum Samples Over Time at Day 1, Day 15 and Day 29|Blood samples for the determination of ranibizumab concentrations were collected in the Ranibizumab treatment arms only at the following time points: within 24 hours after the first administration of ranibizumab, at Day 15 and at Day 29. Only descriptive analysis done.|Day 1 (Baseline), Day 15 and Day 29|The PK Set, which consisted of all participants with at least one valid PK concentration value, was considered.|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
2582729|NCT02375971|Secondary|Percent of Participants With Ocular Adverse Events by Primary System Organ (SOCs) at Week 24|Percent of Participants with Ocular Adverse Events regardless of Study Treatment and Procedure Relationship by Primary System Organ (SOCs) reported categorically (Mild, Moderate, Severe) 24 weeks after the first study treatment. Only descriptive analysis done.|Week 24|The Safety Set was considered.|||Percent of participants|||Number
2582730|NCT02375971|Secondary|Percentage of Participants Having Recurrent ROP and Receiving Any Post-baseline Intervention at or Before Week 24|Recurrence of ROP is defined as subjects receiving any post-baseline intervention in either eye at or before 24 weeks (ranibizumab re-treatment or switch to laser in the ranibizumab groups, switch to ranibizumab treatment in the laser group). Zone I consists of a circle, the radius of which extends from the center of the optic disc to twice the distance from the center of the optic disc to the center of the macula. Zone II extends centrifugally from the edge of zone I to the nasal ora serrata. Only descriptive analysis done.|Week 24|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Percentage of participants|||Number
2582731|NCT02375971|Secondary|Number of Participants Experiencing an Event, From the First Study Treatment to the Last Study Visit|An event was defined as death, treatment switch, or the first occurrence of unfavorable structural outcomes in either eye. Only descriptive analysis done.|Day 1 (after initiation of study treatment) up to study exit (Day 169)|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Participants|||Number
2582732|NCT02375971|Secondary|Percentage of Participants Requiring Interventions With a Second Modality for ROP at Week 24|Intervention for ROP in either eye at or before the 24-week assessment visit with a treatment modality other than the modality of the first study treatment. Only descriptive analysis done.|Week 24|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Percentage of participants|||Number
2582733|NCT02375971|Primary|Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24|To achieve this outcome, patients must fulfill all the following criteria, 1) survival, 2) no intervention with a second modality for ROP, 3) absence of active ROP and 4) absence of unfavorable structural outcome. Retinopathy of prematurity (ROP) is a pathologic process that occurs in the incompletely vascularized, developing retina of low birth-weight preterm neonates.|Week 24|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Percentage of Participants|||Number
2582734|NCT02375724|Secondary|Change From Baseline in the Leicester Cough Questionnaire (LCQ) Total Score at Week 8|The LCQ is a self-administered questionnaire that assesses cough related quality of life The LCQ comprises 19 items and 3 domains (physical, psychological and social) The total score ranges from 3 to 21 and each domain scores range from 1 to 7; a higher score indicates a better quality of life|Week 8|Intent to treat (ITT) population defined as all randomized patients who took at least one dose of investigational medicinal product LCQ data were available for 126/135 patients receiving aclidinium and 128/134 receiving placebo|||Score||Standard Error|Least Squares Mean
2582735|NCT02375724|Secondary|Change From Baseline in Overall E-RS Cough and Sputum Domain Score Over the 8 Week Study Period|The scale range of the 'cough and sputum' domain of the E-RS was 0-11, with higher scores indicating more severe symptoms|Baseline to Week 8|Intent to treat (ITT) population defined as all randomized patients who took at least one dose of investigational medicinal product E-RS data were available for 131/135 patients receiving aclidinium and 133/134 receiving placebo|||Score||Standard Error|Least Squares Mean
2582736|NCT02375724|Primary|Change From Baseline in Overall Exacerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms (E-RS) Total Score Over the 8 Week Study Period|The EXACT-Respiratory Symptoms (E-RS) questionnaire was completed every evening The E-RS scale is an instrument comprising a subset of EXACT items to test the effect of treatment on the severity of respiratory symptoms in stable COPD Eleven of the 14-items of the EXACT questionnaire provides information about COPD symptoms: The E-RS Total Score is an aggregate of three domains: chest symptoms (derived sum of 3 items), cough and sputum (derived sum of 3 items) and RS-breathlessness (derived sum of 4 items); Individual scores were rated from 0 to 4 The E-RS Total score is based on a logit scoring system with conversion to a 0 (lowest score) to 100 scale (highest score) with higher scores indicating more severe symptoms|Baseline to Week 8|Intent to treat (ITT) population defined as all randomized patients who took at least one dose of investigational medicinal product E-RS data were available for 131/135 patients receiving aclidinium and 133/134 receiving placebo|||Score||Standard Error|Least Squares Mean
2582794|NCT02374138|Other Pre-specified|Use of Existing Ancillary Services||Assessed at 6m and 12m following enrollment|Participants with data available at each follow up point|||Participants|||Count of Participants
2582737|NCT02375698|Secondary|Mean Percent Change From Baseline of Participants' Responses to TB Antigens Ag85A and ESAT-6|13-Color PBMC Intracellular Cytokine Staining (ICS) Assay using PBMCs Percent Antigen-specific T Cell DMSO-subtracted, ANY Cytokine Response - Change from Baseline T Cell: CD4|Day 224|Immunogenicity analysis set|||Percent change from baseline||Standard Deviation|Mean
2582738|NCT02375698|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Unsolicited AEs: 28 days after each vaccination Solicited AEs: 7 days after each vaccination SAEs: through Day 420 Adverse events of special interest: through Day 420|Day 0 to Day 420|Safety analysis set|||Participants|||Count of Participants
2582739|NCT02375373|Primary|Changes in Number of 16S RNA Sequences on Days 31, Day 62, and Day 93.|Compare the gut microbiota composition of individual subjects before and after the implementation of a controlled and observed diet of chickpeas and legume products.|Change from Day 31, Day 62, and Day 93|Due to the rate of withdrawal from this study only one participant completed and this data was used for the outcome measures.|||sequences||97.5% Confidence Interval|Mean
2582740|NCT02375347|Primary|Changes in Diversity of Gut Microbiota 16S rRNA Gene Sequences With Regard to Time.|"Compare the gut microbiota composition and overall diversity of individual subjects before and after the implementation of a controlled and observed diet of chickpeas and legume products, using 16S ribosomal RNA (rRNA) sequencing of fecal samples.~The use of Operational Taxonomic Units (OTUs) are used to classify clusters of similar bacterial groups. OTUs are species or group of species often used when only DNA sequence data is available.~This measure is the average amount of OTUs found for each time point."|Change in Baseline (Day 1, Day 7-9, and Day 14)||||Avg. Operational Taxonomic Units||Standard Error|Mean
2582741|NCT02374957|Other Pre-specified|Claudication Symptoms and Rest Pain.|Secondary outcome measures including claudication symptoms and rest pain.|90 days|No data collected due to early termination of study.||||||
2582742|NCT02374957|Other Pre-specified|Number of Participants Who Had a Stroke|Secondary outcome measure - patients who had a stroke during the 90 day follow up period.|90 days||||Participants|||Count of Participants
2582743|NCT02374957|Other Pre-specified|Patients Who Had Amputations Following Initial Procedure.|Patients who went on to have amputations following initial procedure|90 days|Nineteen patients randomized to either Cilostazol or Control group who had lower extremity revascularization.|||Participants|||Count of Participants
2582744|NCT02374957|Other Pre-specified|Number of Participants Affected by Death|Number of Participants affected by Death was reported|90 days|Overall survival|||Participants|||Count of Participants
2582745|NCT02374957|Secondary|Graft Patency, Determined as Opened or Occluded by Duplex Scan Post-intervention.|Graft patency was determined by duplex scan as opened or occluded. Follow-up duplex testing ranged from 13 days to 259 days. Number of patency failures (i.e., graft occlusions) are shown below by treatment arm.|13 days to 259 days|One patient had no scans to determine graft patency.|||Participants|||Count of Participants
2582746|NCT02374957|Primary|Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 3 Months|"The quality of life instrument EACH Q questionnaire was administered at baseline, 6-week and 3-month follow-up visits. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EACH-Q is a four-item questionnaire that estimates the maximum duration that patients can maintain different displacement speeds, ranging from slow walk to running. Values of the total score can range from 0 to 100 with higher scores indicating a better health state. Separate change scores are estimated at each follow-up time point.~With the EACH-Q higher scores are better."|Baseline and 3 months|Only patients with data collected at each pair of time points are included in the analysis.|||score on a scale||Standard Deviation|Mean
2582747|NCT02374957|Primary|Change in Quality of Life Scores - Estimation of Ambulatory Capacity by History-Questionnaire (EACH-Q) at 6 Weeks|"The quality of life instrument EACH Q questionnaire was administered at baseline, 6-week and 3-month follow-up visits. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EACH-Q is a four-item questionnaire that estimates the maximum duration that patients can maintain different displacement speeds, ranging from slow walk to running. Values of the total score can range from 0 to 100 with higher scores indicating a better health state. Separate change scores are estimated at each follow-up time point.~With the EACH-Q higher scores are better."|Baseline and Six Weeks|Only patients with data collected at each pair of time points are included in the analysis.|||score on a scale||Standard Deviation|Mean
2582748|NCT02374957|Primary|Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 3 Months.|"The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The second part of the Euroqol-5D is a analog scale with endpoints labeled best imaginable health state and worst imaginable health state with 0 representing worst health state and 100 representing best health state. Participants choose which number best represents their health on that day. Separate change scores are estimated at each follow-up time point.~Higher numbers are better."|Baseline and 3 months|Only patients with data collected at each pair of time points are included in the analysis.|||score on a scale||Standard Deviation|Mean
2582749|NCT02374957|Primary|Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (Euroqol-5D Visual Analog) at 6 Weeks.|"The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The second part of the Euroqol-5D is a analog scale with endpoints labeled best imaginable health state and worst imaginable health state with 0 representing worst health state and 100 representing best health state. Participants choose which number best represents their health on that day. Separate change scores are estimated at each follow-up time point.~Higher numbers are better."|Baseline and Six Weeks|Only patients with data collected at each pair of time points are included in the analysis.|||score on a scale||Standard Deviation|Mean
2582795|NCT02374138|Other Pre-specified|Parental Health Literacy|Single Item Literacy Screener (SILS)|Baseline||||Participants|||Count of Participants
2590076|NCT02287467|Secondary|Death or Re-hospitalization|Number and percent of participants who died or were re-hospitalized after initial discharge|Day 28|all participants with data|||Participants|||Count of Participants
2582750|NCT02374957|Primary|Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 3 Months|The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. . The descriptive system consists of the following five dimensions: 1) mobility, 2) self-care, 3) usual activities, 4) pain/discomfort, 5 anxiety/depression. Each participant was asked to choose one level that reflects their own health state today for each of the five dimensions. The EQ5D sum score is a composite sum of the individual dimension scores. Values of the total score can range from 5 to 25 with higher scores indicating a worse health state. Separate change scores are estimated at each follow-up time point.|Baseline and 3 months|Only patients with data collected at each pair of time points are included in the analysis.|||score on a scale||Standard Deviation|Mean
2582751|NCT02374957|Primary|Change in Quality of Life in Relation to Use of Cilostazol After Lower Extremity Revascularization (EQ-5D Sum Score) at 6 Weeks|The Euroqol 5D (EQ5D) questionnaire will be completed at baseline, six weeks and three months follow-up. Cross-sectional and change scores will be used to project sample size requirements for a full trial. The EuroQol (EQ-5D) questionnaire is a standardized instrument for measuring generic health status. The descriptive system consists of the following five dimensions: 1) mobility, 2) self-care, 3) usual activities, 4) pain/discomfort, 5 anxiety/depression. Each participant was asked to choose one level that reflects their own health state today for each of the five dimensions. The EQ5D sum score is a composite sum of the individual dimension scores. Values of the total score can range from 5 to 25 with higher scores indicating a worse health state. Separate change scores are estimated at each follow-up time point.|Baseline and 6 weeks.|Only patients with data collected at each pair of time points are included in the analysis.|||score on a scale||Standard Deviation|Mean
2582752|NCT02374671|Secondary|Number of Primary Eyes With DCNVA 20/40 of Better and Gain of 10 Letters More at 6 Months for the Randomized Substudy|The randomized surgery group is defined as successful if the percentage of primary eyes achieving Distance Corrected Near Visual Acuity at 40 centimeters of 20/40 of Better and Gain of 10 Letters more at 6 months postoperative (i.e. 6-month responder rate) is higher than the percentage in the randomized control group.|From date of randomization until the date of study withdrawal or sub-study completion at 6 months, whichever came first.||||Participants|||Count of Participants
2582753|NCT02374671|Primary|Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better and Gain of At Least 10 Letters.|Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters achieving 20/40 or better and Gain of At Least 10 Letters at 24 months for the primary eye.|From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.|Explanted primary eyes were analyzed as failures. Data for primary eyes that missed the 24 month visit, were lost to follow-up, or withdrew consent prior to the 24 month visit were not imputed. Per protocol, primary outcome analysis must be performed on the primary eye only. Fellow eye data is used for safety outcomes and summarized separately.|||Participants|||Count of Participants
2582754|NCT02374593|Secondary|Number of Adjustments Due to Overtreatment in Subjects With Athyreosis, Ectopic and Eutopic Thyroid Glands Compared With Controls|Whether the dose adjustment was made for overtreatment was noted as based on TSH and fT4/T4 results|6 months||||dose adjustments||Standard Error|Mean
2582755|NCT02374593|Primary|Dose Adjustments|Thyroid labs (TSH and fT4/T4) will be monitored per standard care: 2 weeks after initiation of levothyroxine and once monthly during the first 6 months of treatment. The number of dose adjustments required per participant during the first 6 months of treatment were recorded.|6 months||||Number of dose adjustments||Standard Error|Mean
2582756|NCT02374463|Other Pre-specified|Percent Body Fat|change in total body fat measured using Dual-energy X-ray absorptiometry (DXA). Value was calculated as value at 6 months (post) - value at baseline (pre)|6 months||||percentage of body fat||Standard Deviation|Mean
2582757|NCT02374463|Secondary|Change in Strength R Hip Using Biodex|Assessment of change in strength using biodex. Higher values are associated with better outcome|Strength in the R hip was assessed at 6 months (post) and at baseline (pre)|Change calculated as 6 month value (post)- baseline value (pre)|||newton squared||Standard Deviation|Mean
2582758|NCT02374463|Secondary|Number of Subjects Who Reported Falls|This is the number of subjects who self-reported at least one fall, and does not include trips or near falls. This measure does not include the total number of falls as there were several participants who reported more than one fall.|6 months||||participants|||Number
2582759|NCT02374463|Secondary|Change in Strength R Knee Biodex|Change in isometric strength R knee assessed using the biodex measured before and after intervention. Change was calculated as value at 6 months (post)-value at baseline (pre).Higher values are a better outcome|Strength at the R knee was assessed at 6 months (post) and at baseline (pre)||||newton squared||Standard Deviation|Mean
2582760|NCT02374463|Secondary|Functional Gait Analysis|The Functional Gait Assessment (FGA) is designed to assess postural stability during gait. The measure is calculated by summing the scores for 10 gait related tasks. Each task is scored from 3 to 0, where 3 is the best possible performance (normal) and 0 indicates severe impairment related to the task. The best possible score is 30 and the worst possible score is 0. Higher values are associated with better outcome. A value of 22/30 and below is associated with high risk of falling in the community.|FGA ws measured at 6 months (post) and at baseline (pre)|The change in FGA was calculated as the value at 6 months (post)- the value at baseline (pre)|||score on a scale||Standard Deviation|Mean
2582761|NCT02374463|Primary|Balance and Lateral Mobility Assessed by the Four Square Step Test|the Four Square Step Test assesses dynamic balance and coordination through stepping forwards, sideways, and backwards in a timed fashion. The four square step test is timed in seconds. Higher scores are associated with worse outcome. Individuals with higher scores are at increased risk of falling with some using a score of 15 seconds or higher as being at high risk for falls. The minimum value one would see in young healthy populations for this test is 5 seconds. The maximum value is 60 seconds. If they are deemed unable to complete the value is not reported|The FSST was assessed at 6 month (post) and at baseline (pre)|the change in four square step test score is calculated as the 6 month (post) - the baseline value (pre)|||seconds||Standard Deviation|Mean
2582828|NCT02374060|Secondary|Number of Eyes With Endophthalmitis|Count of eyes with an occurrence of endophthalmitis|During 24 weeks of folllow-ip||||Eyes with uveitic macular edema|Eyes with uveitis macular edema||Number
2582764|NCT02374398|Secondary|Post Operative Blood Loss|"The estimated blood loss was determined with the Gross formula [23]. According to a review article published in 2013, Gross's formula though developed in 1983 is still widely used as reported. The formula which is relatively easy to use is described below:~Patient blood volume (PBV) = K (1) x height (m) 3 + K (2) x weight (kg) + K (3) Where K (1) = 0.3669 (male), 0.3561(female); K (2) = 0.03219 (male), 0.03308 (female); And K (3) = 0.6041(male), 0.1833 (female) Estimated blood loss = PBV [Hematocritinitial - Hematocritfinal ] / Hematocritmean Where mean hematocrit is the sum of initial and final hematocrit divided by two."|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups||||ml||Standard Deviation|Mean
2582765|NCT02374398|Primary|The Change in Hematocrit (Ht) From the Day of Surgery|"Control group- iv placebo normal saline plus regular electrocautery.~iv TXA plus regular electrocautery.~iv placebo plus Aquamantys system and regular electrocautery.~iv TXA and Aquamantys system and regular electrocautery"|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups||||Volume % of RBC in blood||Standard Deviation|Mean
2582766|NCT02374398|Primary|The Change in Hemoglobin (Hb) From the Day of Surgery|"Control group- iv placebo normal saline plus regular electrocautery.~iv TXA plus regular electrocautery.~iv placebo plus Aquamantys system and regular electrocautery.~iv TXA and Aquamantys system and regular electrocautery"|day of surgery preoperative time to postoperative day 3 or postoperative day 2 if day 3 data are not recorded for the 4 groups||||g/dl||Standard Deviation|Mean
2582767|NCT02374346|Secondary|Factors Associated With Postoperative Headache|Demographic, anaesthetic and surgical factors associated with postoperative headache|6 months||||participants|||Number
2582768|NCT02374346|Primary|Frequency of Postoperative Headache in Elective Surgery Patients|The observed overall frequency of postoperative headache was 28.3% (N= 126) in the total sample.|6 months|"Frequency of postoperative headache in total sample (n=446), Post-op Headache, no History of Headache (n=229), Post-op Headache, History of Headache (n=217), where n= number of participants analyzed"|||participants|||Number
2582769|NCT02374307|Secondary|No. of Falls|No. of falls in the post-intervention period between 3-months follow-up and 6-months follow-up. Falls are defined as an event, i.e. fall, trip, slip, which results in the person coming to rest on the ground or floor or other lower level.|3 months and 6 months|All subjects with nonmissing observations at 6-months follow-up|||Participants|||Count of Participants
2582770|NCT02374307|Secondary|No. of Participants Exercising Post-intervention|Self-reported exercise behavior post-intervention between 3-months follow-up to 6-months follow-up.|3 months and 6 months|All subjects with nonmissing observations at 6-months follow-up|||Participants|||Count of Participants
2582771|NCT02374307|Secondary|Exercise According to the Protocol. Adherence|No. of participants in the intervention group performing exercises according to the protocol in the intervention period until 3-months follow-up. Participant are encouraged to complete an activity diary where they note if the exercise programme has been executed as planned. If they have not completed sufficient exercises, they are supposed to make a note in the diary.|Baseline and 3 months|All subjects in the intervention group with nonmissing observations at 3-months follow-up|||Participants|||Count of Participants
2582772|NCT02374307|Secondary|Mini Nutritional Assessment|"The summary score of the Mini Nutritional Assessment (MNA) maps to three nutritional statuses Normal nutritional status, Risk of malnutrition and being Malnourished."|Baseline, 3 months, 6 months|Complete, non-missing observations for both groups at baseline. 69 participants completed the 3-months follow-up. In the intervention group, 71 participants completed the 6-months follow-up. In the control group, 64 participants completed the 3-months follow-up, but 3 observations are missing.|||Participants|||Count of Participants
2582773|NCT02374307|Secondary|Walking Habits|Questions regarding walking habits in the last 7 days. Summarized in total minutes walking.|Baseline, 3 months, 6 months|At baseline, one observation was missing in the intervention group. 69 participants completed the 3-months follow-up. In the intervention group, 71 participants completed the 6-months follow-up. In the control group, 64 participants completed the 3-months follow-up.|||Participants|||Count of Participants
2582774|NCT02374307|Secondary|Instrumental Activities of Daily Living|No. of participants with scores on the Instrumental Activities of Daily Living (IADL) scale, Lawton and Brody. IADL is a measure of a person's self-reported ability to perform complex activities of daily living. The summary score ranges from 0 (low function, dependent) to 8 (high function, independent).|Baseline, 3-months, 6-months|Complete, non-missing observations for both groups at baseline. 69 participants completed the 3-months follow-up. In the intervention group, 71 participants completed the 6-months follow-up, with 1 missing observation on IADL. In the control group, 64 participants completed the 3-months follow-up.|||Participants|||Count of Participants
2582775|NCT02374307|Secondary|Falls Efficacy Scale - International|Changes in falls-efficacy measured with the Falls Efficacy Scale - International (FES-I) derives from a self-report questionnaire, assessing concerns about falling in 16 different daily activities. The total score ranges from 16 (no concern) to 64 (high concern). A decrease in scores indicates less concerns.|Baseline, 3 months, 6 months|Intention-to-treat population. Multiple imputation using a predictive mean matching model with arm, age, sex and baseline values of the imputed variable as predictors.|||scores on a scale||Standard Error|Mean
2582776|NCT02374307|Secondary|4-meter Walk Test|Changes in the 4-meter walk test. Participants are asked to walk a distance of 4 meters at their usual pace, measured in m/s|Baseline, 3 months, 6 months|Intention-to-treat population. Multiple imputation using a predictive mean matching model with arm, age, sex and baseline values of the imputed variable as predictors.|||m/s||Standard Error|Mean
2582777|NCT02374307|Secondary|Sit-to-stand Test|Changes in the no. of raises in 30 seconds. From the sitting position, the subject stands completely up, then sits completely back down, repeated for 30 seconds.|Baseline, 3 months, 6 months|Intention-to-treat population. Multiple imputation using a predictive mean matching model with arm, age, sex and baseline values of the imputed variable as predictors.|||raises||Standard Error|Mean
2582778|NCT02374307|Secondary|Berg Balance Scale|Changes in the Berg Balance Scale (BBS), a 14-item scale applied to assess static and dynamic balance in older adults. The summary score ranges from 0 (low, wheelchair bound) to 56 (high, independent)|Baseline, 3 months, 6 months|Intention-to-treat population. Multiple imputation using a predictive mean matching model with arm, age, sex and baseline values of the imputed variable as predictors.|||scores on a scale||Standard Error|Mean
2582779|NCT02374307|Secondary|EQ-5D|Changes in the EuroQOL EQ-5D instrument indicating changes in health-related quality of life. Preference weights for United Kingdom were employed to generate utility scores ranging from -0.59 to 1. A score of 1 is associated with a health state without problems. A positive change in EQ-5D indicates a better health-related quality of life.|Baseline, 3 months, 6 months|Intention-to-treat population. Multiple imputation using a predictive mean matching model with arm, age, sex and baseline values of the imputed variable as predictors.|||scores on a scale||Standard Error|Mean
2582780|NCT02374307|Primary|Short Form 36 Health Survey Summary Scores|Changes in the Short Form 36 Health Survey (SF-36) summary scores from baseline to 3-months follow-up. SF-36 measures health-related quality of life. Its summary score is comprised of a physical component summary (PCS) and a mental component summary (MCS). The scores range from 0-100 (worst-best) in each scale. A positive change in the summary score indicates a better health-related quality of life.|Baseline, 3 months, 6 months|Intention-to-treat population. Multiple imputation using a predictive mean matching model with arm, age, sex and baseline values of the imputed variable as predictors.|||scores on a scale||Standard Error|Mean
2582781|NCT02374255|Secondary|Communication Skills Training|Oncologist's communication skills are tested and rated between 1 and 7, with higher number indicating the oncologists were more comfortable in demonstrating communication skills while having the Goals of Care discussion with their patients.|up to 6 months|Participants represented are the oncologist's. Data collected for the oncologists only.|||number of skills tested||Standard Deviation|Mean
2582782|NCT02374255|Primary|Number of Patients Perception of Improved Goals of Care Discussions|Number of Patient's satisfaction with the discussion of improved goals of care as measured by GoC qualitative patient survey.|up to 6 months|Data collected for patient participants only|||Participants|||Count of Participants
2582783|NCT02374255|Primary|Number of Participants Who Perceived Increased Goals of Care Discussions|Number of patient's perceptions that goals of care discussions were increased occurred as measured by GoC qualitative patient survey.|up to 6 months|Data from patient participants only. Data not collected from Oncologists|||Participants|||Count of Participants
2582784|NCT02374164|Primary|AUCinf: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Febuxostat XR 40 mg (Regimen B) and Febuxostate XR 80 mg (Regimen C) in Fasted States|AUCinf is a measure of total plasma exposure to the drug from time zero extrapolated to infinity. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen B and C.|||ng*hr/mL||Standard Deviation|Mean
2582785|NCT02374164|Primary|AUCinf: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Febuxostat XR 80 mg in Fed (Regimen A) and Fasted (Regimen C) States|AUCinf is a measure of total plasma exposure to the drug from time zero extrapolated to infinity. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen A and C.|||ng*hr/mL||Standard Deviation|Mean
2582786|NCT02374164|Primary|AUCt: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for Febuxostat XR 40 mg (Regimen B) and Febuxostat XR 80 mg (Regimen C) in Fasted States|AUCt is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUCt) Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen B and C.|||ng*hr/mL||Standard Deviation|Mean
2582787|NCT02374164|Primary|AUCt: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for Febuxostat XR 80 mg in Fed (Regimen A) and Fasted (Regimen C) States|AUCt is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen A and C.|||ng*hr/mL||Standard Deviation|Mean
2582788|NCT02374164|Primary|Cmax: Maximum Observed Plasma Concentration for Febuxostat XR 40 mg (Regimen B) and Febuxostat XR 80 mg (Regimen C) in Fasted States|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple time points (up to 48 hours) post dose|Participants from the PK population, all participants who received study drug and had at least 1 measurable plasma concentration who received a single dose of study drug in Regimen B and C.|||ng/mL||Standard Deviation|Mean
2582789|NCT02374164|Primary|Cmax: Maximum Observed Plasma Concentration for Febuxostat XR 80 mg in Fed (Regimen A) and Fasted (Regimen C) States|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Participant blood samples were collected pre-dose and following a single oral dose.|Day 1 pre-dose and at multiple timepoints (up to 48 hours) post dose|Participants from the Pharmacokinetic population (PK), all participants who received study drug and had at least 1 measurable plasma concentration, who received a single dose of study drug in Regimen A and C.|||ng/mL||Standard Deviation|Mean
2582790|NCT02374138|Other Pre-specified|Intervention Fidelity|Checklist of staff's fidelity to individual components of intervention protocol|6 month intervention period|||||||
2582791|NCT02374138|Other Pre-specified|Intervention Satisfaction|Brief survey of satisfaction with intervention components.|6 month intervention period|Participants with data available at 6 month follow up|||Participants|||Count of Participants
2582792|NCT02374138|Other Pre-specified|Intervention Component Uptake|Completion of intervention sessions|6 month intervention period|Intervention group only|||Participants|||Count of Participants
2591615|NCT02268942|Secondary|Mean Length of Initial Hospital Stay|Mean length of initial hospital stay including both acute care (ICU/CCU) and step-down Care time|Initial Hospital Stay||||days||Standard Deviation|Mean
2582796|NCT02374138|Other Pre-specified|Number of Participants With Positive Smoke Exposure|"Participants with environmental smoke exposure. Responses were regrouped as negative (none) or positive (daily, often, or rarely) based on two questions: How often did anyone smoke inside the home where child usually lives? or How often did anyone smoke in the room where child usually sleeps? A positive response on either or both questions was considered positive exposure."|Repeated Measures at 6 and 12 months (3m data collected for repeated measures)|Number of participants with follow up data available at each time point.|||Participants|||Count of Participants
2582797|NCT02374138|Other Pre-specified|Sociodemographics|Age, gender, race, ethnicity, insurance type, parental education, household income, family medical history|Baseline||||Participants|||Count of Participants
2582798|NCT02374138|Secondary|Asthma Morbidity - Daytime Asthma Symptoms, Days of Activity Limitations, and Days of Quick Relief Medicine Use|Days of asthma symptoms, activity limitation, and quick relief medicine use in prior 14d|Repeated measures at 6 and 12 months (3m data collected for repeated measures)|Participants with data available at each follow up time point|||days in prior 14d||Standard Deviation|Mean
2582799|NCT02374138|Secondary|Symptom-free Days in the Last 14 Days|Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications|Repeated Measures at 12 months (with data also assessed at 3m and 6m)|Participants with data available at 12m follow up|||days||Standard Deviation|Mean
2582800|NCT02374138|Secondary|Exacerbations - Hospital Admissions|Number of participants with hospital admissions due to exacerbations|Assessed at 6m and 12m after enrollment|Participants with data available at each time point|||Participants|||Count of Participants
2582801|NCT02374138|Secondary|Parental Resilience|Parental resilience assessed by score on Revised Life Orientation Test (LOT-R) measure. The LOT-R assesses optimism/resilience, and is comprised of 10 questions. Scores range from 0-40, with a higher score indicating a higher level of optimism.|Repeated Measures at 6 and 12 months|Participants with follow up available at each time point|||units on a scale||Standard Deviation|Mean
2582802|NCT02374138|Secondary|Mindfulness|Interpersonal Mindfulness in Parenting|Repeated Measures at 6 and 12 months|We are unable to analyze or report the data because it was not systematically collected.||||||
2582803|NCT02374138|Secondary|Coping Strategies|Brief COPE|Repeated measures at 12m FU (6m data used for repeated measures)|While we have collected this data, its analysis will be complex and require significant resources. We lack those resources at this time. We may at some point in the future return to this analysis.||||||
2582804|NCT02374138|Secondary|Caregiver Smoking Behavior|parent report of cigarettes smoked per day|Repeated Measures at 6 and 12 months|We are unable to analyze or report the data because it was not systematically collected.||||||
2582805|NCT02374138|Secondary|Economic Outcomes|Analysis of costs of care in both groups|12m follow-up period|Data were not collected||||||
2582806|NCT02374138|Secondary|Number of Participants With AEs and SAEs|Safety data: Number of Participants with AEs and SAEs|12m follow up period|Participants available at each time point|||Participants|||Count of Participants
2582807|NCT02374138|Secondary|Caregiver Quality of Life|Caregiver quality of life score, assessed by modified Pediatric Asthma Caregiver Quality of Life Questionnaire (PACQLQ). The measure had five response options, with scores ranging from 13-65 and higher scores meaning better quality of life. No subscales were analyzed.|Repeated Measures at 6 and 12 months (3m data collected for repeated measures)|Participants with follow up available at each time point. Note use of modified scale.|||units on a scale||Standard Deviation|Mean
2582808|NCT02374138|Secondary|Child Depression|PROMIS Parent Proxy Depressive Symptoms is a parent-report assessment of child depression. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression.|Repeated Measures at 6 and 12 months (3m data collected for repeated measures)|Participants available at each time point|||units on a scale||Standard Deviation|Mean
2582809|NCT02374138|Secondary|Child Anxiety|PROMIS Parent Proxy Anxiety. For PROMIS instruments, T-scores rescale the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A higher T-score represents higher anxiety and/or depression.|Repeated Measures at 6 and 12 months (3m data collected for repeated measures)|Participants available at each time point|||units on a scale||Standard Deviation|Mean
2582810|NCT02374138|Secondary|Parental Depression|Score on Center for Epidemiologic Studies Depression Scale (CES-D - 10). The CESD-10 scale screens for depressive symptoms. Scores range from 0-30, with higher scores indicating a higher degree of depressive symptoms.|Repeated Measures at 6 and 12 months (3m data collected for repeated measures)|Participants available at each follow up time point.|||units on a scale||Standard Deviation|Mean
2582811|NCT02374138|Secondary|Parental Stress|Score on Perceived Stress Scale (PSS). The Perceived Stress Scale consists of 10 questions and is a measure of the degree to which situations in one's life are appraised as stressful. Scores range from 0 - 40, with higher scores indicating a higher level of perceived stress.|Repeated Measures at 6 and 12 months (3m data collected for repeated measures)|Number of participants with follow up available at each time point.|||units on a scale||Standard Deviation|Mean
2582812|NCT02374138|Secondary|Asthma Exacerbations - Courses of Systemic Steroids|Courses of systemic steroids over 12m follow up period|Assessed at 6m and 12m following enrollment|Participants with data available at each time point|||Courses of systemic steroids||Standard Error|Mean
2582813|NCT02374138|Secondary|Health Care Utilization - Emergency Department Visits for Asthma|Health care utilization - emergency department visits for asthma over six month and twelve month follow up periods. Reported as those documented in the electronic medical record of Children's National Health System plus parent report of visits elsewhere|12 months after enrollment|Participants with follow up available at each time point|||Visits||Standard Error|Mean
2582814|NCT02374138|Secondary|Asthma Medication Adherence|Reported use of inhaled corticosteroids and LTRA in past two days|Repeated Measures at 6 and 12 months (3m data collected for repeated measures)|Participants with Follow Up Data Available at Each Time Point|||Participants|||Count of Participants
2582815|NCT02374138|Secondary|Asthma Severity and Control||Repeated Measures at 3, 6, and 12 months|Data not collected||||||
2582816|NCT02374138|Secondary|Asthma Morbidity - Nighttime Asthma Symptoms|Nights of asthma symptoms in prior 14d|Repeated Measures at 6 and 12 months (3m data collected for repeated measures)|Participants with data available at each follow up time point|||days in prior 14d||Standard Deviation|Mean
2582817|NCT02374138|Primary|Symptom-free Days in the Last 14 Days|Symptom-free days are defined as a 24-hour period with no coughing, wheezing, chest tightness, or shortness of breath and no need for rescue medications|Repeated Measures at 6 months (3 month data collected to allow for repeated measures)|Randomized participants with follow up available at each time period.|||days in prior 14d||Standard Deviation|Mean
2582818|NCT02374099|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Treatment-emergent adverse events (TEAEs) were defined as any AEs that begin or worsen with an onset date on or after the date of the first dose of IP through 28 days after the last dose. A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based on the participant's symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity as follows: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death.|Randomization to 28 days after the last dose of IP; those AEs known at any time thereafter being related to IP; up to the last subject last visit of 21 November 2017; TEAE follow-up occurred up to 155 weeks and 2 days|The safety population included all randomized participants who received at least 1 dose of IP.|||Participants|||Count of Participants
2582819|NCT02374099|Secondary|Kaplan Meier Estimate of Duration of Response (DoR)|Duration of response was defined as the time from the first tumor assessment when the confirmed CR/PR criterion was first met to the date of disease progression, based on investigator's assessment following RECIST Version 1.1 criteria.|From the date of randomization of study drug to the data cut-off of 13 December 2016; follow up for duration of response was 21 months|Only participants who had a confirmed CR or PR response are included.|||months||95% Confidence Interval|Median
2582820|NCT02374099|Secondary|Kaplan Meier Estimate of Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death (from any cause). All participants who were lost to follow up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.|From the date of randomization of study drug to the data cut off date of 13 December 2016; participants were followed for overall survival for 21 months|The ITT population included all randomized participants regardless of whether the participant received any IP or had any efficacy assessments collected.|||months||95% Confidence Interval|Median
2582821|NCT02374099|Secondary|Percentage of Participants Who Achieved a Confirmed CR, PR or Stable Disease (SD) for ≥ 24 Weeks (Clinical Benefit Rate) by Investigator Assessment|Percentage of participants with CR or PR or SD was defined per RECIST criteria v 1.1 as a CR that includes a disappearance of all target lesions, a PR was defined as having at least a 30% decrease in the sum of diameters of target lesions from baseline and SD as neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease. The two-sided 95% exact binomial CI each arm was estimated by the Clopper-Pearson method.|Disease response was assessed every 8 weeks, for the first 24 weeks, then every 12 weeks until DP; from date of randomization of study drug to the data cut-off date of 13 December 2016; follow-up for clinical benefit response was 21 months|The ITT population included all randomized participants regardless of whether the participant received any IP or had any efficacy assessments collected.|||Percentage of Participants||95% Confidence Interval|Number
2582822|NCT02374099|Secondary|Percentage of Participants Who Achieved a Confirmed Complete Response (CR) or Partial Response (PR) to Treatment (Objective Response Rate) Based On the Investigator Assessment|Overall response rate was defined as the percentage of participants who achieved a confirmed complete response or partial response based on RECIST Version 1.1 criteria. RECIST criteria v 1.1 defined a CR as the disappearance of all target lesions and a PR with at least a 30% decrease in the sum of diameters of target lesions from baseline. The two-sided 95% exact binomial CI for each arm was estimated by the Clopper-Pearson method.|Disease response was assessed every 8 weeks, for the first 24 weeks, then every 12 weeks until DP; from date of randomization of study drug to data cut-off date of 13 December 2016; follow-up for overall response was 21 months|The ITT population included all randomized participants regardless of whether the participant received any IP or had any efficacy assessments collected.|||Percentage of Participants||95% Confidence Interval|Number
2582823|NCT02374099|Primary|Kaplan-Meier Estimate of Progression Free Survival (PFS)|Progression-free survival was defined as the duration from the date of randomization to the date of disease progression (DP) based on investigator's assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 or death (from any cause), whichever occurred first. Per RECIST 1.1, progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions from nadir or appearance of a new lesion.|From the date of randomization of study drug to the date of the cut off date of 13 December 2016; follow-up for PFS was 21 months|The Intent-to-treat population included all randomized participants regardless of whether the participant received any investigational product or had any efficacy assessments collected.|||months||95% Confidence Interval|Median
2582824|NCT02374060|Secondary|Cumulative Proportion of Eyes With an IOP Elevation >=30 mm Hg|Cumulative proportion of eyes with uveitic macular edema that experience elevated IOP to >=30 mm Hg during 24 weeks of follow-up.|During 24 weeks of follow-up||||Cumulative proportion of eyes at 24 wks|Eyes with uveitis macular edema|95% Confidence Interval|Number
2582825|NCT02374060|Secondary|Cumulative Proportion of Eyes With an IOP Elevation >=24 mm Hg|Cumulative proportion of eyes with uveitic macular edema that experience elevated IOP to >=24 mm Hg during 24 weeks of follow-up.|During 24 weeks of follow-up|As randomized|||Cumulative proportion of eyes at 24 wks|Eyes with uveitis macular edema|95% Confidence Interval|Number
2582826|NCT02374060|Secondary|Cumulative Proportion of Eyes With an IOP Elevation of >=10 mm Hg Over Baseline|Cumulative proportion of eyes with uveitic macular edema that experience an IOP elevation of >=10 mm Hg higher than the baseline level during 24 weeks of follow-up.|During 24 weeks of follow-up||||Cumulative proportion of eyes at 24 wks|Eyes with uveitis macular edema|95% Confidence Interval|Number
2582827|NCT02374060|Secondary|Cumulative Proportion of Eyes With Severe Vision Loss|Cumulative proportion of eyes with uveitic macular edema who experience severe vision loss (>= 15 standard letters) during the 24 weeks of follow-up.|During 24 weeks of follow-up||||Cumulative proportion of eyes at 24 wks|Eyes with uveitis macular edema|95% Confidence Interval|Number
2582831|NCT02374060|Secondary|Change in Best-corrected Visual Acuity at 24 Weeks|Mean change in best-corrected visual acuity from baseline to 24 weeks. Participants' visual acuity was measured by certified examiners with best refractive correction in place.Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity.|Over 24 weeks of follow-up||||Standard letters|Eyes with uveitis macular edema|95% Confidence Interval|Mean
2582832|NCT02374060|Secondary|Change in Best-corrected Visual Acuity at 8 Weeks|Mean change in best-corrected visual acuity from baseline to 8 weeks. Participants' visual acuity was measured by certified examiners with best refractive correction in place.Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity.|Over 8 weeks of follow-up||||Standard letters|Eyes with uveitis macular edema|95% Confidence Interval|Mean
2582833|NCT02374060|Secondary|Proportion of Eyes With Resolution of Macular Edema at 24 Weeks|Proportion of eyes with resolution of macular edema defined as normalization of the macular thickness (i.e., <260 um on the standard scale) at 24 weeks.|Over 24 weeks of follow-up||||Proportion of eyes|Eyes with uveitis macular edema|95% Confidence Interval|Number
2582834|NCT02374060|Secondary|Proportion of Eyes With Resolution of Macular Edema at 8 Weeks|Proportion of eyes with resolution of macular edema defined as normalization of the macular thickness (i.e., < 260 um on the standardized scale) at 8 weeks. The greater the proportion the more eyes achieved resolution of macular edema.|Over 8 weeks of follow-up||||Proportion of eyes|Eyes with uveitis macular edema|95% Confidence Interval|Number
2582835|NCT02374060|Secondary|Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 24 Weeks|Proportion of eyes with >=20% reduction in macular thickness (or normalization of macular thickness even if there is <20% reduction) at 24 weeks|Over 24 weeks of follow-up||||Proportion of eyes|Eyes with uveitis macular edema|95% Confidence Interval|Number
2582836|NCT02374060|Secondary|Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 8 Weeks|Proportion of eyes with >=20% reduction in macular thickness (or normalization of macular thickness even if there is <20% reduction) at 8 weeks.|Over 8 weeks of follow-up||||Proportion of eyes|Eyes with uveitis macular edema|95% Confidence Interval|Number
2582837|NCT02374060|Secondary|Proportion of Baseline Central Subfield Thickness Observed at 24 Weeks|The primary outcome is the change in central subfield thickness from baseline to 24 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better.The time point of 24 weeks was chosen to evaluate the duration of response and the need for additional injections.Retinal thickness was evaluated using masked assessments of OCT images.|At baseline and the 24 week visit|"All eyes with uveitic macular edema at randomization according to assigned treatment (as randomized)"|||proportion of baseline retinal thickness|Eyes with uveitis macular edema|99.87% Confidence Interval|Mean
2582838|NCT02374060|Primary|Proportion of Baseline Central Subfield Thickness Observed at 8 Weeks|"The primary outcome is the change in central subfield thickness from baseline to 8 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better.~The time point of 8 weeks was chosen for assessment of the primary outcome because it encompasses the window for maximum benefit for all three treatment strategies. Retinal thickness was evaluated using masked assessments of OCT images."|At baseline and 8 weeks|"All eyes with uveitic macular edema at randomization according to assigned treatment (as randomized)"|||proportion of baseline retinal thickness|Eyes with uveitis macular edema|99.87% Confidence Interval|Mean
2582839|NCT02373865|Secondary|Glycemic Variability (Profile) of Sitagliptin Compared to Glimepiride|The glycemic profile is defined as the area under the glucose-timeprofile obtained by continuous glucose monitoring (5 days baseline and 5 days after 12 weeks of each treatment)|12 weeks (at baseline and at EOT)|"Due to an impeded recruitment of patients the study was terminated. Between start (March 2015) and premature termination (Jan 2017) only 4 patients could be recruited. The reason for 0 Participants Analyzed provided in the Analysis Population Description is intended to report that data were not reported due to the termination of the study."||||||
2582840|NCT02373865|Secondary|Occurence and Number of Nocturnal Ventricular Arrhythmias|measurement of nocturnal ventricular arrhythmias at baseline and EOT (after 12 weeks of treatment) - per patient, couplets per patient, triplets per patient)|12 weeks (at baseline and at EOT)|"Due to an impeded recruitment of patients the study was terminated. Between start (March 2015) and premature termination (Jan 2017) only 4 patients could be recruited. The reason for 0 Participants Analyzed provided in the Analysis Population Description is intended to report that data were not reported due to the termination of the study."||||||
2582841|NCT02373865|Primary|Number of Hypoglycemic Episodes (HE) Under Treatment With Sitagliptin Compared to Glimepiride|measurement of hypoglycemic episodes including event duration at baseline and EOT after 12 weeks of treatment and measurement of time spent below critical values for hypoglycemic episodes are the primary objectives of this study. We will calculate overall episodes/time (5 days) and nocturnal episodes.|12 weeks (at baseline and at EOT)|"Due to an impeded recruitment of patients the study was terminated. Between start (March 2015) and premature termination (Jan 2017) only 4 patients could be recruited. The reason for 0 Participants Analyzed provided in the Analysis Population Description is intended to report that data were not reported due to the termination of the study."||||||
2582842|NCT02373852|Primary|Number of Patients That Undergo Successful SVG Procedure|Successful procedure is considered as a procedure in which no distal embolization, dissection, perforation, abrupt closure or no reflow occurred.|30 Days||||Participants|||Count of Participants
2582843|NCT02373852|Primary|Number of Participants With Adverse Events During the Procedure and up to 30 Days Following Procedure|Collect and analyse all adverse events occurred during and following the SVG procedure up to 30 days.|30 Days||||Participants|||Count of Participants
2582844|NCT02373371|Secondary|Lesions Disappearance Rate at 6 Months From Baseline.|"The number of lesions is assessed at baseline (before treatment) and 6 month later.~The difference in lesions is recorded for each patient. The rate is the quotient:  difference in lesions between baseline and at 6 month /nubmer of lesions at baseline"|0(baseline), 6 month||||percentage of disappeared lesions||Standard Deviation|Mean
2582845|NCT02373371|Secondary|Lesions Disappearance Rate at 1 Months From Baseline.|"The number of lesions is assessed at baseline (before treatment) and 1 month later.~The difference in lesions is recorded for each patient. The rate is the quotient:  difference in lesions between baseline and at 1 month /nubmer of lesions at baseline"|0(baseline),1 month||||percentage of disappeared lesions||Standard Deviation|Mean
2582846|NCT02373371|Secondary|Pain Assesment|"Pain assesment with a VAS Pain scale~Visual analog scale [VAS] is a continuous scale comprised of a horizontal scale of 10 cm length . The scale is anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10)."|at inclusion (after treatment)||||units on a scale||Standard Deviation|Mean
2582847|NCT02373371|Primary|Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12|"The number of lesions is assessed at baseline (before treatment) and 12 weeks later.~The difference in lesions is recorded for each patient. The mean of disappeared lesions are then calculated for all patients."|Baseline and Week 12||||number of lesions||Standard Deviation|Mean
2582848|NCT02373202|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters|"Criteria for potentially clinically significant abnormalities:~Alanine Aminotransferase (ALT): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN~Aspartate aminotransferase (AST): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN~Alkaline phosphatase: >1.5 ULN~Total bilirubin (TBILI): >1.5 ULN; >2 ULN~Conjugated bilirubin(CBILI): >1.5 ULN~Unconjugated bilirubin: >1.5 ULN~ALT >3 ULN and TBILI >2 ULN~CBILI >35% TBILI and TBILI >1.5 ULN~Albumin: <=25 g/L"|Baseline up to Week 58|Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.|||participants|||Number
2582849|NCT02373202|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters|"Criteria for potentially clinically significant abnormalities:~Creatinine: >=150 micromol/L (adults); >=30% change from baseline, >=100% change from baseline~Creatinine clearance: <15 mL/min; >=15 to <30 mL/min; >=30 to <60 mL/min; >=60 to <90 mL/min~Blood urea nitrogen: >=17 mmol/L~Uric acid: <120 micromol/L; >408 micromol/L"|Baseline up to Week 58|Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.|||participants|||Number
2582850|NCT02373202|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes|"Criteria for potentially clinically significant abnormalities:~Sodium: <=129 mmol/L; >=160 mmol/L~Potassium: <3 mmol/L; >=5.5 mmol/L~Chloride: <80 mmol/L; >115 mmol/L"|Baseline up to Week 58|Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.|||participants|||Number
2582851|NCT02373202|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters|"Criteria for potentially clinically significant abnormalities:~Glucose: <=3.9 mmol/L and <LLN; >=11.1 mmol/L (unfasted [unfas]) or >=7 mmol/L (fasted [fas])~Hemoglobin A1c (HbA1c): >8%~Total cholesterol: >=6.2 mmol/L; >=7.74 mmol/L~LDL cholesterol: >=4.1 mmol/L; >=4.9 mmol/L~Triglycerides: >=4.6 mmol/L; >=5.6 mmol/L"|Baseline up to Week 58|Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.|||participants|||Number
2582852|NCT02373202|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52|HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each items's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.|Baseline, Week 52|mITT population included all randomized participants who received at least one dose of IMP, irrespective of compliance with the study protocol and procedures. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2582853|NCT02373202|Secondary|Change From Baseline at Week 52 in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP)|DAS28-CRP is a composite score that contains 4 variables: TJC (based on 28 joints), SJC (based on 28 joints), participant's assessment of general health on VAS (range 0 [very well] to 100 mm [extremely bad]) and CRP (mg/L). DAS28-CRP total score ranges from 2-10 with a lower score indicating less disease activity. A DAS28-CRP above 5.1 indicates high disease activity, whereas below 3.2 indicates low disease activity and below 2.6 as disease remission.|Baseline, Week 52|mITT population included all randomized participants who received at least one dose of IMP, irrespective of compliance with the study protocol and procedures. Here ‘Overall Number of Participants Analyzed’ signifies participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2582869|NCT02373137|Secondary|Corneal Higher-Order Aberrations|Corneal anterior and posterior surface higher-order aberrations (HOA) were measured with Scheimpflug imaging (Pentacam) before surgery and at 3, 6, and 12 months post-operatively. Zernike orders 3-8 were calculated at 4.0- and 6.0-mm-diameter optical zones. The results reported here represent total HOA (Sum of Zernike orders 3-8). Note a single observation was not available for one eye in the DMEK group at 6 months, this was analyzed with last observation carried forward.|3, 6, 12 months||||root mean square in micrometers|eyes|Standard Deviation|Mean
2582870|NCT02373137|Secondary|Endothelial Cell Count||24 months||2019-12-31|12/2019||||
2582871|NCT02373137|Secondary|Endothelial Cell Count||3, 6, 12 months||||cells/mm^2|eyes|Standard Deviation|Mean
2583037|NCT02370615|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)||Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.|||participants|||Number
2582854|NCT02373202|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20, 50 and 70 Responses at Week 52|ACR response is a composite rating scale that includes 7 variables: tender joints count (TJC [68 joints]); swollen joints count (SJC [66 joints]); levels of an acute phase reactant (high sensitivity C-reactive protein [hs-CRP level]); participant's assessment of pain (measured on 0 [no pain]-100 mm [worst pain] visual analog scale [VAS]); participant's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by Health Assessment Question-Disability Index [HAQ-DI], with scoring range of 0 [better health] - 3 [worst health]). ACR20/50/70 response is defined as at least 20/50/70% improvement in both TJC and SJC, and at least 20/50/70% improvement in at least 3 of the 5 other assessments, respectively.|Week 52|mITT population included all randomized participants who received at least one dose of IMP, irrespective of compliance with the study protocol and procedures.|||percentage of participants|||Number
2582855|NCT02373202|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters|"Criteria for potentially clinically significant abnormalities:~Hemoglobin: <=115 g/L (Male[M]) or <=95 g/L (Female[F]); >=185 g/L (M) or >=165 g/L (F); DFB >=20 g/L~Hematocrit: <=0.37 v/v (M) or <=0.32 v/v (F); >=0.55 v/v (M) or >=0.5 v/v (F)~Red blood cells (RBC): >=6 Tera/L~Platelets: <50 Giga/L; >=50 and <100 Giga/L; >=700 Giga/L~White blood cells (WBC): <3.0 Giga/L (Non-Black [NB]) or <2.0 Giga/L (Black [B]); >=16.0 Giga/L~Neutrophils: <1.5 Giga/L (NB) or <1.0 Giga/L (B); <1.0 Giga/L~Lymphocytes: <0.5 Giga/L; >=0.5 Giga/L and <lower limit of normal (LLN); >4.0 Giga/L~Monocytes: >0.7 Giga/L~Basophils: >0.1 Giga/L~Eosinophils: >0.5 Giga/L or >upper limit of normal (ULN) (if ULN >=0.5 Giga/L)"|Baseline up to Week 58|Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.|||participants|||Number
2582856|NCT02373202|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities|"Criteria for potentially clinically significant ECG abnormalities:~PR Interval: >200 milliseconds (ms); >200 ms and IFB >=25%; >220 ms; >220 ms and IFB >=25%; >240 ms; >240 ms and IFB >=25%~QRS Interval: >110 ms; >110 ms and IFB >=25%; >120 ms; >120 ms and IFB >=25%~QT Interval: >500 ms~QTc Bazett (QTc B): >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms, IFB >60 ms~QTc Fridericia (QTc F): >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms; IFB >60 ms"|Baseline up to Week 58|Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.|||participants|||Number
2582857|NCT02373202|Primary|Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities|"Criteria for potentially clinically significant vital sign abnormalities:~Systolic blood pressure (SBP) supine: <=95 mmHg and decrease from baseline (DFB) >=20 mmHg; >=160 mmHg and increase from baseline (IFB) >=20 mmHg~Diastolic blood pressure (DBP) supine: <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB ≥10 mmHg~SBP (Orthostatic): <=-20 mmHg~DBP (Orthostatic): <=-10 mmHg~Heart rate (HR) supine: <=50 beats per minute (bpm) and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm~Weight: >=5% DFB; >=5% IFB"|Baseline up to Week 58|Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.|||participants|||Number
2582858|NCT02373202|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|Adverse event (AE) was defined as any untoward medical occurrence in a participant who received IMP and did not necessary have to had a causal relationship with treatment. All AEs that occurred from the first dose of the IMP administration up to 6 weeks after last dose of treatment (up to Week 58) were considered as TEAEs. SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. TEAEs included both SAEs and non-SAEs.|Baseline up to Week 58|Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.|||participants|||Number
2582859|NCT02373137|Other Pre-specified|Adverse Events/Complication Rates|composite measure|3, 6, 12, 24 months|||||||
2582860|NCT02373137|Other Pre-specified|Operative Times||Baseline|||||||
2582861|NCT02373137|Other Pre-specified|Graft Thickness|As measured by Optical coherence tomography (OCT) and Pachymetry|3, 6, 12, 24 months|||||||
2582862|NCT02373137|Other Pre-specified|Refraction|Manifest refraction using phoropter|3, 6, 12, 24 months|||||||
2582863|NCT02373137|Secondary|Graft Failure/Graft Rejection||Baseline to 24 months||2019-12-31|12/2019||||
2582864|NCT02373137|Secondary|Graft Failure/Graft Rejection||Baseline 12 months||||eyes|eyes||Count of Units
2582865|NCT02373137|Secondary|National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ)|"The National Eye Institute has developed the validated Visual Functioning Questionnaire (NEI-VFQ) to assess the effect of ocular conditions and vision on patient quality of life. The answers to the questionnaire are transformed into sub-scales, including: general health, general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision. Participants are assigned a numerical value for each sub-scale based on their answers between 0-100, where higher numbers indicate better visual function. These sub-scales are then combined according to National Eye Institute guidelines into an overall composite score for each participant. This overall composite score is also on a scale of 0-100, where higher numbers indicate better visual function.~Composite score based on National Eye Institute guidelines."|Baseline, 12 months|"For this analysis, all second eyes (enrolled eyes belonging to a patient that had enrolled their other eye and already had surgery on that eye as part of this study) were removed. For this reason the total number of eyes equals the total number of participants."|||Composite scores on a scale|eyes|Standard Deviation|Mean
2582866|NCT02373137|Secondary|Interface Haze|As measured by Pentacam densitometry|24 months||2019-12-31|12/2019||||
2582867|NCT02373137|Secondary|Interface Haze|As measured by Pentacam densitometry|3, 6, 12 months||2019-12-31|12/2019||||
2582868|NCT02373137|Secondary|Corneal Higher-Order Aberrations|As measured by Pentacam|24 months||2019-12-31|12/2019||||
2605712|NCT02107014|Primary|Change in BDNF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2582872|NCT02373137|Secondary|Best Spectacle-Corrected Visual Acuity|The BSCVA was recorded at 4 meters by a masked refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL).|24 Months||2019-12-31|12/2019||||
2582873|NCT02373137|Secondary|Best Spectacle-Corrected Visual Acuity|The BSCVA was recorded at 4 meters by a masked refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL).|3 and 12 months||||logMAR|eyes|Standard Deviation|Mean
2582874|NCT02373137|Primary|Best Spectacle-Corrected Visual Acuity|The BSCVA was recorded at 4 meters by a masked refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL).|6 months|One patient lost to followup|||logMAR|eyes|Standard Deviation|Mean
2582875|NCT02373124|Primary|Cocaine Use|Participants were provided choices to use up to 5 hits of cocaine on up to 2 occasions (cocaine versus money). Participants who chose cocaine (1 or more hits) during the first choice opportunity are administered a 52 minute infusion of 0.71 mg/kg ketamine the following day. Another choice opportunity occurs 24 hours later. The primary outcome is the choice participants made during these occasions|5 weeks|medically healthy, treatment-seeking cocaine dependent individuals without a history of abuse of or adverse reaction to ketamine or benzodiazepines.|||Participants|||Count of Participants
2582876|NCT02373098|Secondary|Percent of Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients|Peripheral blood chemokine cytokine levels measured by flow cytometry in healthy controls at baseline and in RRMS patients between visits during fingolimod treatment|Baseline, Month 3, Month 6|Intent to treat. Data analyzed in RRMS patients.|||percent of cell count||Standard Error|Mean
2582877|NCT02373098|Secondary|Absolute Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients|"Peripheral blood chemokine cytokine levels measured by flow cytometry at baseline and between visits during fingolimod treatment.~Absolute counts of the cells were calculated according to the absolute lymphocyte counts and the percentages of cells. This allowed for a clear determination of cell counts and thus increased the reliability of the results."|Baseline, Month 3, Month 6|Intent to treat. Data analyzed in RRMS patients.|||absolute cell count||Standard Error|Mean
2582878|NCT02373098|Primary|Percent Blood Cytokines and Chemokines Via Flow Cytometry Analyses of Healthy Controls and RRMS Patients at Baseline|Baseline peripheral blood flow cytometric analyses in study participants evaluated by flow cytometry analysis.|Baseline|Analysis was done in the healthy volunteers and RRMS patients.|||Percent of cells||Standard Error|Mean
2582879|NCT02373098|Secondary|Peripheral Blood Cytokine and Chemokine Measurements in Healthy Controls and RRMS Patients|Peripheral blood chemokine cytokine levels measured by flow cytometry during fingolimod treatment in healthy controls at baseline and in RRMS patients between visits|Baseline, Month 3, Month 6|Intent to treat. Data analyzed in RRMS patients.|||pg/ml||Standard Error|Mean
2582880|NCT02373098|Secondary|Serum Cytokine and Chemokine Levels inRRMS Patients Between Visits|Change of serum cytokine and chemokine levels measured by ELISA in RRMS patients treated with fingolimod between visits|Baseline, month 3, month 6|Intent to treat|||pg/ml||Standard Error|Mean
2582881|NCT02373098|Primary|Baseline Flow Cytometry Analyses for Blood Cytokines and Chemokines in Healthy Controls and RRMS Patients|baseline peripheral blood flow cytometric analysis in study participants|Baseline|Analysis was done in the healthy volunteers and RRMS patients.|||absolute cell count||Standard Error|Mean
2582882|NCT02373098|Primary|Baseline Serum Cytokine and Chemokine Levels of Healthy Controls and RRMS Patients - ELISA|Blood samples were taken at baseline and measurements were performed before treatment of fingolimod.|Baseline|Intent to treat|||pg/ml||Standard Error|Mean
2582883|NCT02372799|Secondary|Change in Clinical Global Impressions-Severity (CGI-S) Score|The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients.|From Baseline to Week 8|The Intent-to-Treat (ITT) Population will consist of all patients in the Safety Population who had baseline and at least 1 postbaseline assessment of the Children’s Depression Rating Scale-Revised (CDRS-R) total score.|||units on a scale||Standard Error|Least Squares Mean
2582884|NCT02372799|Primary|Change in Children's Depression Rating Scale-Revised (CDRS-R) Total Score|The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.|From Baseline to Week 8|The Intent-to-Treat (ITT) Population will consist of all patients in the Safety Population who had baseline and at least 1 postbaseline assessment of the Children’s Depression Rating Scale-Revised (CDRS-R) total score.|||units on a scale||Standard Error|Least Squares Mean
2582885|NCT02372682|Primary|2D-SWE Measurements' Capability of Predicting Stages of Fibrosis Based on Ishak Scoring System|Ishak is a tool used to evaluate liver fibrosis via liver biopsy to report severity and prognosis of liver disease, specifically hepatitis.|2 years||||percentage of exams|||Number
2582886|NCT02372682|Primary|2D-SWE Measurements' Capability of Predicting Stages of Fibrosis Based on METAVIR Scoring System|METAVIR score is a tool used to measure fibrosis as seen on liver biopsy and scored to describe liver disease progress and prognosis.|2 years||||percentage of exams|||Number
2582887|NCT02372396|Primary|Clinician Administered PTSD Scale -5 (CAPS-5) PTSD Severity|Clinical interview that quantifies PTSD symptomatology according to DSM-5, generating a continuous measure of severity (range 0-80) where higher scores indicate more symptomatology|Baseline and 10 weeks|Completer analysis|||units on a scale||Standard Deviation|Mean
2583051|NCT02370602|Secondary|Cavg During the Positron Emission Tomography (PET) Scan Period (AUC(Scan)) at 3 Hours Post-dose for TAK-063 and TAK-063 Metabolite M-I|Cavg values of TAK-063 and TAK-063 metabolite M-I during the PET scan at approximately 3 hours post TAK-063 administration.|3 hours post-dose|Pharmacokinetic Analysis Set|||ng/mL||Standard Deviation|Mean
2582888|NCT02372344|Primary|The Effect of Food Timing (Fasting, Before Meal, and After Meal) on PK (AUC0-72) of AZD0585 in Healthy Male Japanese.|To investigate the effect of food timing on PK (area under the plasma concentration-time curve from time zero to 72 hours [AUC0-72]) of single dose of 4 g AZD0585 in healthy male Japanese by assessing plasma concentrations of total EPA and total DHA, and PK parameters over time under the three proposed conditions (fasting, before meal, and after meal). Analyses of the outcome measures presented are for baseline-adjusted data for total EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation. The geometric mean was calculated as the exponential of the arithmetic mean calculated from data on a log scale.|Blood samples were collected from pre-dose (Day -1) up to 72 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK set included all healthy subjects in the safety population (ie, who received at least 1 administration of AZD0585 and for whom any post-dose data were available) with at least 1 detectable total EPA and total DHA plasma concentration.|||mg⋅h/mL||Geometric Coefficient of Variation|Geometric Mean
2582889|NCT02372344|Primary|The Effect of Food Timing (Fasting, Before Meal, and After Meal) on PK (Cmax) of AZD0585 in Healthy Male Japanese.|To investigate the effect of food timing on PK (maximum plasma concentration [Cmax]) of single dose of 4 g AZD0585 in healthy male Japanese by assessing plasma concentrations of total EPA and total DHA, and PK parameters over time under the three proposed conditions (fasting, before meal, and after meal). Analyses of the outcome measures presented are for baseline-adjusted data for total EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation. The geometric mean was calculated as the exponential of the arithmetic mean calculated from data on a log scale.|Blood samples were collected from pre-dose (Day -1) up to 72 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK set included all healthy subjects in the safety population (ie, who received at least 1 administration of AZD0585 and for whom any post-dose data were available) with at least 1 detectable total EPA and total DHA plasma concentration.|||microgram/millilitre (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2582890|NCT02372344|Primary|The Effect of Food Timing (Fasting, Before Meal, and After Meal) on Pharmacokinetics (PK; AUC) of AZD0585 in Healthy Male Japanese.|To investigate the effect of food timing on PK (area under the plasma concentration-time curve from time zero to infinity [AUC]) of single dose of 4 g AZD0585 in healthy male Japanese by assessing plasma concentrations of total eicosapentaenoic acid (EPA) and total docosahexaenoic acid (DHA), and PK parameters over time under the three proposed conditions (fasting, before meal, and after meal).|Blood samples were collected from pre-dose (Day -1) up to 72 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK set included all healthy subjects in the safety population (ie, who received at least 1 administration of AZD0585 and for whom any post-dose data were available) with at least 1 detectable total EPA and total DHA plasma concentration.|||milligram x hour /millilitre (mg⋅h/mL)||Geometric Coefficient of Variation|Geometric Mean
2582891|NCT02372253|Other Pre-specified|Beta Cell Markers|Beta cell markers. We will collect serum at baseline and at Week 12 and Months 6, 9 and 12 for future assessment of putative beta cell markers.|12 weeks and 12 months|||||||
2582892|NCT02372253|Secondary|Hypoglycemic Events|Glycemic control, as measured by hypoglycemic events.|12 months||||events per month||Standard Error|Mean
2582893|NCT02372253|Secondary|HbA1c|Glycemic control, as measured by HbA1c. In addition to being an important determinant of residual beta cell function/survival, it also helps reveal a more complete picture of beta cell function.|12 weeks||||Percent||Standard Error|Mean
2582894|NCT02372253|Secondary|HbA1C|Glycemic control, as measured by HbA1c. In addition to being an important determinant of residual beta cell function/survival, it also helps reveal a more complete picture of beta cell function.|12 months||||Percent||Standard Error|Mean
2582895|NCT02372253|Secondary|Percent Change From Baseline in Exogenous Insulin Requirements|Percent change in exogenous insulin requirements over the last 7-14 consecutive days at 12 weeks. This will be assessed as a surrogate inverse marker of residual beta cell function.|12 weeks||||Percent Change||Standard Error|Mean
2582896|NCT02372253|Secondary|Percent Change From Baseline in Exogenous Insulin Requirements|Percent change in exogenous insulin requirements over the last 7-14 consecutive days at 12 months. This will be assessed as a surrogate inverse marker of residual beta cell function.|12 months||||Percent Change||Standard Error|Mean
2582897|NCT02372253|Primary|Functional Beta Cell Mass|Functional Beta Cell Mass as determined by the area under the curve (AUC) from a 2-hour Mixed Meal-Stimulated C-peptide after daily verapamil for 12 months. A greater improvement in insulin production (as an indirect measure of beta cell mass) in subjects receiving verapamil as compared to those receiving placebo would provide an indication of the efficacy of this intervention. The C-peptide AUC (0-120 min) was calculated by using the trapezoidal rule and was divided by the time of the test to obtain the mean AUC (in nmol/L).|12 months||||nmol/L||Standard Error|Mean
2582898|NCT02372097|Secondary|Number of Participants Who Had Abnormal and Clinically Significant 12-lead Electrocardiograms (ECG) Findings After Study Drug Administration|Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.|Baseline up to 7 days after the last dose of study drug (Day 8) in each period|The safety analysis set included all participants who received study drug.|||participants|||Number
2582899|NCT02372097|Secondary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values||Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2|The safety analysis set included all participants who received study drug.|||participants|||Number
2582900|NCT02372097|Secondary|Number of Participants With TEAEs Related to Body Weight||Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2|The safety analysis set included all participants who received study drug.|||participants|||Number
2582901|NCT02372097|Secondary|Number of Participants With TEAEs Related to Vital Signs||Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2|The safety analysis set included all participants who received study drug.|||participants|||Number
2583139|NCT02370121|Primary|High-density Lipoprotein Cholesterol (HDL-C)|The blood sample for determining of HDL-C, was taken after an overnight fast and was evaluated by colorimetric method. The value was expressed on mmol/L.|Week 12||||mmol/L||Standard Deviation|Mean
2582902|NCT02372097|Secondary|Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs)|Collection of AEs commenced from the time that the participant was first administered study drug in Period 1 (Day 1). Routine collection of AEs continued until the end (hospital discharge) of Period 2 (Day 29).|Day 1 of Period 1 up to the day of hospital discharge (Day 29) in Period 2|The safety analysis set included all participants who received study drug.|||participants|||Number
2582903|NCT02372097|Secondary|Apparent Terminal Elimination Rate Constant (λz) for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.|||per hour(hr-1)||Standard Deviation|Geometric Mean
2582904|NCT02372097|Secondary|MRT: Mean Residence Time From Time Zero to Infinity for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.|||hr||Standard Deviation|Geometric Mean
2582905|NCT02372097|Secondary|Tmax: Time to Reach the Cmax for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.|||hour(hr)||Full Range|Median
2582906|NCT02372097|Secondary|AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.|||ng*hr/mL||Standard Deviation|Geometric Mean
2582907|NCT02372097|Primary|Cmax: Maximum Observed Plasma Concentration for SYR-472Z||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.|||nanogram per milliliter(ng/mL)||Standard Deviation|Geometric Mean
2582908|NCT02372097|Primary|AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Unchanged SYR-472 (SYR-472Z)||Day 1: pre dose (within 3 hours prior to dosing), and at multiple time points (up to 168 hours) post dose in each period|The PK analysis set included all participants who received study drug, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for PK.|||nanogram hour per milliliter(ng*hr/mL)||Standard Deviation|Geometric Mean
2582909|NCT02372071|Primary|BiliCare TcB Result Compared to TSB Result||30 minutes within taking the blood draw for TSB (either before or after the blood draw)||||mg/dL||Standard Deviation|Mean
2582910|NCT02372058|Primary|BiliCare TcB Result Compared to TSB Result||30 minutes within taking the blood draw for TSB (either before or after the blood draw)||||mg/dL||Standard Deviation|Mean
2582911|NCT02371980|Secondary|Time From Randomization to Relapse of Major Depressive Disorder During the Entire 32-Week Double-Blind Treatment Period|Relapse was defined as either 1) MADRS Score ≥22, 2) lack of efficacy as determined by the investigator or 3) other unsatisfactory treatment response judged by the investigator. Time to relapse was defined as date of relapse - date of randomization + 1 (where date of relapse is the date of last dose, or date of last contact if date of last dose is missing, for participant with a relapse). Participants without relapse were censored. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score ranges from 0 to 60. Higher scores indicate greater severity of symptoms. The IQR was 25th percentile to 75th percentile.|From date of double-blind randomization (Week 16) up to relapse or 32 weeks of Double-blind Period which occurs first (Up to Week 44)|FAS included all participants who were randomized in the double-blind period and received at least 1 dose of double-blind study drug.|||weeks||Inter-Quartile Range|Median
2582912|NCT02371980|Secondary|Clinical Global Impression Scale-Global Improvement Scale (CGI-I) Score|The CGI-I scale assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale where 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 32|FAS included all participants who were randomized in the double-blind period and received at least 1 dose of double-blind study drug. Overall number of participants analyzed is the number of participants with data available for analyses.|||scores on scale||Standard Deviation|Mean
2582913|NCT02371980|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) Score at Each Week Assessed|The CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participant who have the same diagnosis. Considering total clinical experience, a participant was assessed on severity of mental illness on the following scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=extremely ill. Baseline II is defined as the last non-missing observation prior to the first dose of double-blind study drug. MMRM was used for analyses.|Double-blind Baseline (BL) II and Double-blind Period: Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32|FAS included all participants who were randomized in the double-blind period and received at least 1 dose of double-blind study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||scores on scale||Standard Error|Least Squares Mean
2582923|NCT02371850|Secondary|Area Under the Curve (AUC) Attained With and Without Heating in Each of the Two Nicotine Patches (Reference and Generic)|Area under the curve (AUC) attained with and without heating in each of the two nicotine patches (reference and generic).|Four procedure days for each participant|Data analysis completed for AUC (see below), but not yet for Tmax.|||ng*hr/ml||Standard Deviation|Mean
2583020|NCT02370667|Secondary|Change in Isometric Knee Extensor and Flexor Strength|The peak torque developed during knee extension and flexion during a maximum voluntary isometric contraction was measured by use of a Biodex System 2 isokinetic dynamometer. The mean (95% confidence interval) difference in torque (follow-up - baseline) was computed for each of the three study arms. Data is presented as Nm/kg.|Week 1 and Week 13||||Change in Nm/kg||95% Confidence Interval|Mean
2582914|NCT02371980|Secondary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher score indicates greater severity of symptoms. Baseline II is defined as the last non-missing observation prior to the first dose of double-blind study drug. Mixed model for repeated measures (MMRM) was used for analyses.|Double-blind Baseline (BL) II and Double-blind Period: Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32|FAS included all participants who were randomized in the double-blind period and received at least 1 dose of double-blind study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||scores on scale||Standard Error|Least Squares Mean
2582915|NCT02371980|Primary|Time From Randomization to Relapse of Major Depressive Disorder During the First 28 Weeks of the 32-Week Double-Blind Treatment Period|Relapse was defined as either 1) MADRS Score ≥22, 2) lack of efficacy as determined by the investigator or 3) other unsatisfactory treatment response judged by the investigator. Time to relapse was defined as date of relapse - date of randomization + 1 (where date of relapse is the date of last dose, or date of last contact if date of last dose is missing, for participant with a relapse). Participants without relapse were censored at date of withdrawal or date of Week 28 visit, whichever was earliest. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score ranges from 0 to 60. Higher scores indicate greater severity of symptoms. The inter-quartile range (IQR) was 25th percentile to 75th percentile.|From date of double-blind randomization (Week 16) up to relapse or first 28 weeks of Double-blind Period which occurs first (Up to Week 44)|Full Analysis Set (FAS) included all participants who were randomized in the double-blind period and received at least 1 dose of double-blind study drug.|||weeks||Inter-Quartile Range|Median
2582916|NCT02371876|Secondary|Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding Views/Behaviors Related to Self-Monitoring Blood Glucose|Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on views and behaviors related to managing their diabetes. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree' or 'No Answer or Not Applicable'. The percents (of subjects who responded) that were 'Strongly Agree','Agree','Neutral' about views/behaviors related to self-monitoring blood glucose were calculated.|1 hour|Percent (of those who responded) who 'Strongly Agree', 'Agree', 'Neutral' was calculated for each statement. Abbreviations used: 'HCP' is HealthCare Professional and 'Acc' is Accuracy|||Percentage of Participants Who Responded|||Number
2582917|NCT02371876|Secondary|Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS|Staff obtained responses from persons with diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree'. The percent of subjects who provided responses that were 'Strongly Agree','Agree','Neutral' about each statement was calculated.|1 hour||||Percentage of Participants Who Responded|||Number
2582918|NCT02371876|Secondary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 12.5mg/dL (<100mg/dL) and Within +/- 12.5% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 12.5mg/dL (<100mg/dL YSI capillary plasma) and +/- 12.5% (>= 100mg/dL YSI capillary plasma).|1 hour||||Percentage of BG Results|||Number
2582919|NCT02371876|Secondary|Percent of Venous Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI venous plasma) and +/- 15% (>= 100mg/dL YSI venous plasma).|1 hour|132 (134-2) Blood glucose results were analyzed. Venipunctures were unsuccessful for two subjects.|||Percentage of BG Results|||Number
2582920|NCT02371876|Secondary|Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method When Tested by Study Staff|Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma).|1 hour||||Percentage of BG Results|||Number
2582921|NCT02371876|Secondary|Percent of Alternate Site Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested Alternate Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma).|1 hour|126 (134-8) Blood glucose results were analyzed. Four subjects with low blood sugar did not attempt palm testing per protocol. Four subjects had low blood sugar; their palm results were not evaluable per protocol.|||Percentage of BG Results|||Number
2582922|NCT02371876|Primary|Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma).|1 hour||||Percentage of BG Results|||Number
2582954|NCT02371759|Primary|Baseline Systolic Blood Pressure||Baseline, 0 minutes||||milimeters of Hg||Standard Deviation|Mean
2582924|NCT02371850|Primary|Measurement of Maximum Plasma Concentration (Cmax)|The main outcome measure of the study is the measurement of maximum plasma concentration (Cmax)|four procedure days for each participant|Ten adult smokers between 24 and 44 years of age at the time of enrollment completed the study. The clinical study was an single-group, open-label study. Each subject completed 4 study visits where in-vivo nicotine levels were measured using a reference patch (Nicoderm CQ) and a generic patch (Aveva)|||ng/ml||Standard Deviation|Mean
2582925|NCT02371785|Secondary|Interventional Procedure Time|Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.|Procedure|Interventional procedure time for subjects.|||min||Standard Deviation|Mean
2582926|NCT02371785|Secondary|Total Procedure Time|Defined as the time measured from the insertion of the hemostasis sheath until procedure complete (guide catheter removed).|Procedure|Total procedure time for subjects.|||min||Standard Deviation|Mean
2582927|NCT02371785|Secondary|Contrast Volume|Total amount of contrast used during CorPath procedure.|Procedure|Total amount of contrast used during CorPath procedure for subjects.|||ml||Standard Error|Mean
2582928|NCT02371785|Secondary|Fluoroscopy Time|As recorded by an X-ray system utilized during the procedure.|Procedure|Procedure time for subjects measured from the insertion of the hemostasis sheath until the removal of the guide catheter.|||min||Standard Error|Mean
2582929|NCT02371785|Secondary|Clinical Procedural Success|Defined as <50% residual stenosis in all CorPath 200 System treated lesions at the completion of the interventional procedure (without an unplanned switch to the manual procedure) in the absence of device-related SAE, either within twenty-four (24) hours of the procedure or prior to hospital discharge, whichever occurs first.|24-hours|Achievement of <50% residual stenosis in all robotic system treated lesions at the completion of the interventional procedure without an unplanned switch to the manual procedure in the absence of device-related serious adverse events.|||participants|||Number
2582930|NCT02371785|Primary|Adverse Events|No device-related serious adverse events during the procedure.|Procedure|Device-related events that occured in subjects treated.|||Participants|||Count of Participants
2582931|NCT02371785|Primary|Device Technical Success|"Number of lesions for which there was technical success as accurate and appropriate."|Procedure|29 lesions treated in 20 subjects.|||lesions|lesions||Number
2582932|NCT02371759|Secondary|Local Postoperative Complications|Postoperative paresthesia by clinical examination|24 hours, 7 days||||Participants|||Count of Participants
2582933|NCT02371759|Secondary|Postoperative Analgesia|Number of participants who experienced postoperative pain, VAS, NRS|up to 24 hours after tooth extraction||||Participants|||Count of Participants
2582934|NCT02371759|Secondary|Width of Anesthetic Field After Maxillary Infiltration Anesthesia|Soft tissue numbness area determined by pin-prick test after maxillary infiltration anesthesia. Not tested for mandibular ablock anesthesia.|Up to 10 minutes after injection of local anesthesia||||milimeters||Standard Deviation|Mean
2582935|NCT02371759|Secondary|Onset of Intraoral Local Anesthesia|Evaluated by pin-prick after subjective feeling of soft tissue numbness appeared after local anesthesia injection|Up to 10 minutes, until subjective feeling of soft tissue numbnes||||minutes||Standard Deviation|Mean
2582936|NCT02371759|Primary|Electrocardiogram at 20 Minutes|ECG 15 minutes after local anesthesia injection, 20 minutes after baseline measurement|20th minute||||Participants|||Count of Participants
2582937|NCT02371759|Primary|Electrocardiogram at 15 Minutes|ECG 10 minutes after local anesthesia injection, 15 minutes after baseline measurement|15th minute||||Participants|||Count of Participants
2582938|NCT02371759|Primary|Electrocardiogram at 10 Minutes|ECG 5 minutes after local anesthesia injection, 10 minutes after baseline measurement|10th minute||||Participants|||Count of Participants
2582939|NCT02371759|Primary|Baseline Electrocardiogram||baseline, 0 minutes||||Participants|||Count of Participants
2582940|NCT02371759|Primary|Ceart Rate at 35 Minutes|Heart rate 30 minutes after local anesthesia injection, 35 minutes after baseline measurement|35th minute||||beats per minute||Standard Deviation|Mean
2582941|NCT02371759|Primary|Heart Rate at 20 Minutes|Heart rate 15 minutes after local anesthesia injection, 20 minutes after baseline measurement|20th minute||||beats per minute||Standard Deviation|Mean
2582942|NCT02371759|Primary|Heart Rate at 15 Minutes|Heart rate 10 minutes after local anesthesia injection, 15 minutes after baseline measurement|15th minute||||beats per minute||Standard Deviation|Mean
2582943|NCT02371759|Primary|Heart Rate at 10 Minutes|Heart rate 5 minutes after local anesthesia injection, 10 minutes after baseline measurement|10th minute||||beats per minute||Standard Deviation|Mean
2582944|NCT02371759|Primary|Baseline Values of Heart Rate||baseline, 0 minutes||||beats per minute||Standard Deviation|Mean
2582945|NCT02371759|Primary|Diastolic Blood Pressure at 35 Minutes|Diastolic blood pressure values 30 minutes after local anesthesia injection|35th minute||||milimeters of Hg||Standard Deviation|Mean
2582946|NCT02371759|Primary|Diastolic Blood Pressure at 20 Minutes|Diastolic blood pressure values 15 minutes after local anesthesia injection|20th minute||||milimeters of Hg||Standard Deviation|Mean
2582947|NCT02371759|Primary|Diastolic Blood Pressure at 15 Minutes|Diastolic blood pressure values 10 minutes after local anesthesia injection|15th minute||||milimeters of Hg||Standard Deviation|Mean
2582948|NCT02371759|Primary|Diastolic Blood Pressure at 10 Minutes|Diastolic blood pressure values 5 minutes after local anesthesia injection|10th minute||||milimeters of Hg||Standard Deviation|Mean
2582949|NCT02371759|Primary|Baseline Diastolic Blood Pressure||baseline, 0 minutes||||milimeters of Hg||Standard Deviation|Mean
2582950|NCT02371759|Primary|Systolic Blood Pressure at 35 Minutes|Systolic blood pressure values 30 minutes after local anesthesia injection|35th minute||||milimeters of Hg||Standard Deviation|Mean
2582951|NCT02371759|Primary|Systolic Blood Pressure at 20 Minutes|Systolic blood pressure values 15 minutes after local anesthesia injection|20th minute||||milimeters of Hg||Standard Deviation|Mean
2582952|NCT02371759|Primary|Systolic Blood Pressure at 15 Minutes|Systolic blood pressure values 10 minutes after local anesthesia injection|15th minute||||milimeters of Hg||Standard Deviation|Mean
2582953|NCT02371759|Primary|Systolic Blood Pressure at 10 Minutes|Systolic blood pressure values 5 minutes after local anesthesia injection|10th minute||||milimeters of Hg||Standard Deviation|Mean
2582955|NCT02371759|Primary|Intensity of Intraoral Local Anesthesia|"Number of participants who reported values > 0 after pin-prick testing, using Visual Analogue Scale (VAS) and Numerical Rating Scale (NRS). VAS is represented by line 100 mm long, with one end marked with 0 and words no pain , while the other end is marked with 100 and words the worst pain imanginable. VRS scale is represented by line 100 mm long, marked with numbers from 0 to 10, where 0 corresponds to no pain, and 10 corresponds to the worst pain imaginable. For both scales, higher scores represent worse outcomes."|Up to 10 minutes after local anesthesia injection||||Participants|||Count of Participants
2582956|NCT02371759|Primary|Duration of Intraoral Local Anesthesia|Time until cessation in soft tissue numbness|Up to 6 hours after local anesthesia injection||||minutes||Standard Deviation|Mean
2582957|NCT02371746|Primary|Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1)|Average intraocular pressure (IOP) diurnal measurement is calculated by taking the average of the intraocular pressure measurements at 8AM, 10AM and 4PM. The protocol was later amended (Amendment 09) to a safety only study so the diurnal measurements were no longer collected for Cohorts 2 and 3; only the 8AM IOP was collected as a safety assessment only.|Baseline and Day 25|Safety Population|||mm Hg||Standard Deviation|Mean
2582958|NCT02371668|Secondary|Viral Shedding|Percentage of participants who experienced influenza viral shedding|Evaluated daily for 10 days|All participants who were challenged with H1N1 and received CR6261|||Percentage of participants|||Number
2582959|NCT02371668|Secondary|Total FLUPRO Score|Objective symptoms score from patient directed FLUPRO questionnaire (inFLUenza Patient-Reported Outcome dairy) . The FLUPRO questionnaire uses a 5-point ordinal scale, with higher scores indicating a more frequent sign or symptom. Total scores can range from 0 (symptom free) to 4 (maximum severity of symptoms). Daily scores (Day 0 - Day 8) are averaged to calculate a total score for each participant, then calculated the median total FLUPRO score for each arm.|Evaluated from day 0 to day 8|All participants who were challenged with H1N1 and received CR6261|||Scores on a scale||95% Confidence Interval|Median
2582960|NCT02371668|Secondary|Symptoms|Percentage of participants who experienced influenza symptoms|Evaluated daily for 10 days|All participants who were challenged with H1N1 and received CR6261|||Percentage of participants|||Number
2582961|NCT02371668|Secondary|Number of Symptoms|Number of unique influenza symptoms experienced after influenza challenge|Evaluated for up to 2 months|All participants who were challenged with H1N1 and received CR6261|||Symptoms||95% Confidence Interval|Median
2582962|NCT02371668|Secondary|Mild to Moderate Influenza Disease|Percentage of participants who experienced influenza symptoms and shedding|Evaluated daily for 10 days|All participants who were challenged with H1N1 and received CR6261|||Percentage of participants|||Number
2582963|NCT02371668|Secondary|Days of Symptoms|Duration in days symptoms were experienced after influenza challenge|Evaluated for up to 2 months|All participants who were challenged with H1N1 and received CR6261|||Days||95% Confidence Interval|Median
2582964|NCT02371668|Secondary|Days of Shedding|Duration in days viral shedding was detected after influenza challenge|Evaluated for up to 2 months|All participants who were challenged with H1N1 and received CR6261|||Days||95% Confidence Interval|Median
2582965|NCT02371668|Secondary|Confirmed Influenza Infection|Percentage of participants who experienced either viral shedding or symptoms + a four fold rise in convalescent HAI titer.|Evaluated daily for 10 days + 8 weeks convalescent follow up|All participants who were challenged with H1N1 and received CR6261|||percentage of participants|||Number
2582966|NCT02371668|Primary|Area Under the Curve (AUC) of Viral Shedding|Area under the curve (AUC) calculated from quantitative real-time RT-PCR for influenza A taken from 3 time per day nasal swab collection.|3 times a day for 10 days|All participants who were challenged with H1N1 and received CR6261|||ViralLoad(log(copies/ml))per time(hours)||Inter-Quartile Range|Median
2582967|NCT02371629|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death|This endpoint reports patients affected by any adverse events (AE), serious adverse events (SAE) and death. Only treatment emergent AE, SAE, deaths are reported for this endpoint.|26 Weeks|The Safety Set (SAF) included all patients who received at least one dose of study drug whether or not they were randomized. Patients were analyzed according to the treatment they received. If patients switched treatment during the study, they were to be analyzed according to the treatment to which they were randomized.|||Count of Participants|||Number
2582968|NCT02371629|Secondary|Change From Baseline in Mean Daily COPD Symptom Score at Week 26|Patients reported symptoms by using an electronic diary. The mean daily total symptom score, the mean morning symptom score and the mean evening symptom score were calculated for each patient over 26 weeks. Each symptom measured in a numeric rating scale of 0-10; 0 indicates no symptom and 10 indicates severe symptom. 0 is no waking due to symptoms, 1 woke up once, 2 woke up more than once due to symptoms ; 10 was the worst score.The daily score for an individual symptom score was the worst of the morning and evening scores on a particular day. If either the morning or evening score was missing for a symptom then the non-missing value was taken as the worst. A negative change indicates improvement. Only the scores for the 6 COPD symptoms (respiratory symptoms, cough, wheeze, production of sputum, sputum color, and breathlessness) were used to derive the total symptom score|Baseline, 26 Weeks|The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment to which they were randomized. Patients with evaluable data at both baseline and week 26 were included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
2582969|NCT02371629|Secondary|Change From Baseline in the Percentage of Days With no Rescue Medication Use Over the 26 Weeks|Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. change from baseline in percentage of days without rescue medication usage over 26 weeks was analyzed.|Baseline, 26 Weeks|The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment to which they were randomized. Patients with evaluable data at both baseline and week 26 were included in this analysis.|||percentage of days||Standard Error|Least Squares Mean
2583021|NCT02370667|Secondary|Change in Mobility Performance (Stair Ascent)|Mobility performance was measured using the Stair Ascent Test. For this test, the time taken to ascent nine stairs is recorded. The mean (95% confidence interval) difference in time in seconds (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13||||Change in seconds||95% Confidence Interval|Mean
2582970|NCT02371629|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Individual Timepoints at Week 26|Mixed model for repeated measures was used to analyze change from baseline in FEV1. Baseline FEV1 is defined as the average of the -45 min and -15 min FEV1 values taken on Day 1 prior to first dose.|Baseline, Week 26 (Day 183-184)|The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. Following intent-to-treat principle, patients in FAS were analyzed according to the treatment to which they were randomized. n = number of patients included in respective analysis (i.e. who had a FEV1 at this timepoint on at least one visit).|||Liters||Standard Error|Least Squares Mean
2582971|NCT02371629|Secondary|Change From Baseline in Inspiratory Capacity (IC) at Individual Timepoints at Week 26|Mixed model for repeated measures was used to analyze change from baseline in IC.|Baseline, Week 26 (Day 183-184)|The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. Following intent-to-treat principle, patients in FAS were analyzed according to the treatment to which they were randomized. n = number of patients included in respective analysis (i.e. who had a IC at this timepoint on at least one visit).|||Liters||Standard Error|Least Squares Mean
2582972|NCT02371629|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Individual Timepoints at Week 26|Mixed model for repeated measures was used to analyze change from baseline in FVC. Baseline FVC is defined as the average of the -45 min and -15 min FVC values taken on Day 1 prior to first dose.|Baseline, Week 26 (Day 183-184)|The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. Following intent-to-treat principle, patients in FAS were analyzed according to the treatment to which they were randomized. n = number of patients included in respective analysis (i.e. who had a FVC at this time point on at least one visit).|||Liters||Standard Error|Least Squares Mean
2582973|NCT02371629|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Week 26|Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 defined as the mean of two measurements at 23 hours 15 minutes and 23 hour 45 minutes post dosing. Baseline FEV1 was defined as the average of the -45 minutes and -15 minutes FEV1 values taken on Day 1. An analysis-of-covariance (ANCOVA) for repeated measurements, also known as mixed model for repeated measures (MMRM), was performed for the change from baseline of trough FEV1. The model included treatment, COPD severity, baseline smoking status, baseline ICS use, region, and visit (Day 1, and Weeks 12 and 26) as factors and baseline FEV1 as a covariate.|Baseline, Day 1, Week 26|The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment to which they were randomized. Patients with evaluable data at both baseline and post-baseline time points were included in this analysis.|||Liters||Standard Error|Least Squares Mean
2582974|NCT02371629|Secondary|Percentage of Patients With a Clinically Important Improvement on Transitional Dyspnea Index (TDI) Focal Score at Week 12 and Week 26|"Breathlessness at Week 12 and Week 26 is measured using the Transition Dyspnea Index (TDI). On day 1, breathlessness is assessed by the Baseline Dyspnea Index (BDI). Baseline Dyspnea Index (BDI)/Transition Dyspnea Index (TDI) focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score.~Clinically important improvement indicates ≥ 1 unit in the TDI focal score at Weeks 12 and 26 in comparison to BDI focal score (an increase of ≥ 1)."|Baseline, 12 Weeks, 26 Weeks|The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment to which they were randomized. n= the number of patients with a TDI focal score|||Percentage of patients|||Number
2582975|NCT02371629|Secondary|Change From Baseline in Transitional Dyspnea Index (TDI) Focal Score at Week 12 and Week 26|Breathlessness at Week 12 and Week 26 is measured using the Transition Dyspnea Index (TDI). On day 1, breathlessness is assessed by the Baseline Dyspnea Index (BDI). Baseline Dyspnea Index (BDI)/Transition Dyspnea Index (TDI) focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score.|Baseline, 12 Weeks, 26 Weeks|The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment to which they were randomized. Patients with evaluable data at both baseline and post-baseline time points were included in this analysis.|||score on a scale||Standard Error|Least Squares Mean
2582976|NCT02371629|Secondary|Percentage of Patients With a Clinically Significant Improvement in St George Respiratory Questionnaire at Week 12 and Week 26|"The health status, as reported by the patients, is assessed using the St. George's Respiratory Questionnaire (SGRQ).~The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD:~Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity~Part II covers Activity and is concerned with activities that caused or are limited by breathlessness~Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease.~A score was calculated for each of these three subscales and the total score was calculated. In each case, the lowest possible value was 0 and the highest 100.~A clinically significant improvement is defined as ≥ 4 unit improvement from baseline score (a decrease of ≥ 4)."|Baseline, 12 Weeks, 26 Weeks|The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment to which they were randomized. n= the number of patients with a SGRQ total score at both baseline and indicated post-baseline time point|||percentage of patients|||Number
2583035|NCT02370615|Primary|Number of Participants With TEAEs Related to Body Weight||Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.|||participants|||Number
2582977|NCT02371629|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire (SGRQ) Score at Week 12 and Week 26|"The health status, as reported by the patients, is assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD:~Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity~Part II covers Activity and is concerned with activities that caused or are limited by breathlessness~Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease.~A score was calculated for each of these three subscales and the total score was calculated. In each case, the lowest possible value was 0 and the highest 100. Higher values corresponded to greater impairment of health status."|Baseline, 12 Weeks, 26 Weeks|The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. Following intent-to-treat principle, patients in the FAS were analyzed according to the treatment to which they were randomized. Patients with evaluable data at both baseline and post-baseline time points were included in this analysis.|||score on a scale||Standard Error|Least Squares Mean
2582978|NCT02371629|Secondary|Change From Baseline in Area Under The Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) for Different Time Spans Post Dosing at Week 26|The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) is assessed for different time spans (0-12h, 0-24h, 12-24h) within the overall serial measurement post dosing at week 26 of treatment. Baseline FEV1 was defined as the average of the -45 minutes and -15 minutes FEV1 values taken on Day 1.|Baseline, 0-12 hour, 0-24 hour , 12-24 hour post dose at Week 26|The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. Following intent-to-treat principle, patients in the FAS were analyzed according to the treatment to which they were randomized. Patients with evaluable data at both baseline and week 26 in different time spans were included in this analysis.|||Liters||Standard Error|Least Squares Mean
2582979|NCT02371629|Secondary|Change From Baseline in Area Under The Curve (AUC 0-12 Hour) for Forced Expiratory Volume in One Second (FEV1) Post Dosing at Day 1|The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) is assessed for 0-12 hour, post dosing at Day 1 of treatment. Baseline FEV1 was defined as the average of the -45 minutes and -15 minutes FEV1 values taken on Day 1.|Baseline, 0-12 hour post dose at Day 1|The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment to which they were randomized. Patients with evaluable data at both baseline and Day 1 were included in this analysis.|||Liters||Standard Error|Least Squares Mean
2582980|NCT02371629|Secondary|Change From Baseline in Area Under The Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) for Different Time Spans Post Dosing at Week 12|The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) is assessed for different time spans (0-12h, 0-24h, 12-24h) within the overall serial measurement post dosing at week 12 of treatment. Baseline FEV1 was defined as the average of the -45 minutes and -15 minutes FEV1 values taken on Day 1.|Baseline, 0-12 hour, 0-24 hour , 12-24 hour post dose at Week 12|The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment to which they were randomized. Patients with evaluable data at baseline and week 12 in different time spans were included in this analysis.|||Liters||Standard Error|Least Squares Mean
2582981|NCT02371629|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12|Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 defined as the mean of two measurements at 23 hours 15 minutes and 23 hour 45 minutes post dosing. Baseline FEV1 was defined as the average of the -45 minutes and -15 minutes FEV1 values taken on Day 1. An analysis-of-covariance (ANCOVA) for repeated measurements, also known as mixed model for repeated measures (MMRM), was performed for the change from baseline of trough FEV1 at Week 12. The model included treatment, COPD severity, baseline smoking status, baseline ICS use, region, and visit (Day 1, and Weeks 12 and 26) as factors and baseline FEV1 as a covariate.|Baseline, Week 12|The Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. Following the intent-to-treat principle, patients in the FAS were analyzed according to the treatment to which they were randomized. Patients with evaluable data at both baseline and week 12 were included in this analysis.|||Liters||Standard Error|Least Squares Mean
2582982|NCT02371616|Secondary|Change From Baseline in Tactile Threshold at Week 4 and Week 8|Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentine surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.|At Baseline, Week 4 and Week 8|Analysis for this outcome was performed on PP population which is defined as all participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violations.|||gram (g)||Standard Deviation|Mean
2582983|NCT02371616|Secondary|Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Schiff Sensitivity Score at Week 4 and Week 8|Evaporative air sensitivity was measured by examiner as the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth.|At Baseline, Week 4 and Week 8|Analysis for this outcome was performed on PP population which is defined as all participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violations.|||score on a scale||Standard Deviation|Mean
2605713|NCT02107014|Primary|Change in M-CSF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2582984|NCT02371616|Secondary|Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 4|"Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 mm VAS, were 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth."|At Baseline and Week 4|Analysis for this outcome was performed on PP population which is defined as all participants in the ITT population who had at least one assessment of efficacy considered unaffected by protocol violations.|||score on a scale||Standard Deviation|Mean
2582985|NCT02371616|Primary|Mean Change From Baseline in Evaporative Air Sensitivity as Measured by Visual Analogue Score (VAS) at Week 8|"Evaporative air sensitivity was assessed by examiner as a response to a 1 second application of air from a triple air dental syringe applied to the exposed dentine surface of hypersensitive tooth from a distance of approximately 1centimeter. Each participants rated the intensity of their response to the stimulus using a 100 millimeter (mm) VAS, were 0 represented no pain and 100 represented the worst pain imaginable. Change from baseline was calculated as mean score at the given time point minus mean score at baseline of the two selected test teeth."|At Baseline and Week 8|Analysis for this outcome was performed on per protocol (PP) population which is defined as all participants in the intent to treat (ITT) population who had at least one assessment of efficacy considered unaffected by protocol violations.|||score on a scale||Standard Deviation|Mean
2582986|NCT02371395|Primary|Malaria Diagnosis Using RealAmp and Microscopy.|These are the results of the different tests used in the evaluation.|12 months|Those were patients presenting with suspected malaria.|||Participants|||Count of Participants
2582987|NCT02371369|Other Pre-specified|Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response Based on Tumor Volume Score (TVS) After Receiving Pexidartinib Compared With Those on Placebo by Week 49|Best overall response (CR or PR) was assessed using tumor volume score (TVS) in the ITT population. Tumor Volume Score is a semi-quantitative MRI scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor.|By Week 49|Best overall response on Tumor Volume Score was assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Placebo Part 1, Pexidartinib Part 2; and All Pexidartinib Treated participants. Participants who received Placebo Part 1 only or Pexidartinib Part 2 only were not analyzed..|||Percentage of participants|||Number
2582988|NCT02371369|Other Pre-specified|Mean Change From Baseline for Worst Pain Numeric Rating Scale Score (NRS) in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49|"The Brief Pain Inventory (BPI) Worst Pain NRS was a 1-item, self-administered questionnaire assessing the worst pain in the last 24 hours. The NRS for this item ranged from 0 (no pain) to 10 (pain as bad as you can imagine)."|By Week 49|Worst pain was assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Placebo Part 1, Pexidartinib Part 2; and All Pexidartinib Treated participants. Participants who received Placebo Part 1 only or Pexidartinib Part 2 only were not analyzed.|||units on a scale||Standard Deviation|Mean
2582989|NCT02371369|Other Pre-specified|Mean Change From Baseline for Worst Stiffness Numeric Rating Scale Score (NRS) in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49|"The Worst Stiffness Numeric Rating Scale (NRS) was a 1-item, self-administered questionnaire assessing the worst stiffness in the last 24 hours. The NRS for this item ranged from 0 (no stiffness) to 10 (stiffness as bad as you can imagine)."|Baseline, Week 25, and Week 49|Worst stiffness was assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Placebo Part 1, Pexidartinib Part 2; and All Pexidartinib Treated participants. Participants who received Placebo Part 1 only or Pexidartinib Part 2 only were not analyzed.|||units on a scale||Standard Deviation|Mean
2582990|NCT02371369|Other Pre-specified|Mean Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49|The Patient-reported Outcomes Measurement Information System (PROMIS) physical function scale was used to assess physical function of the upper and lower limbs. The scale ranged from 1 defined as 'unable to do' or 'cannot do' to 5 defined as 'without any difficulty' or 'not at all', where higher scores represent better outcomes.|By Week 49|Physical function was assessed in the ITT population.|||units on a scale||Standard Deviation|Mean
2582991|NCT02371369|Other Pre-specified|Mean Change From Baseline For Range of Motion (ROM) Score in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49|Range of motion (ROM) of the joint was assessed by a qualified, independent, and blinded or third-party assessors at the clinical site. Measurements were recorded in degrees. At baseline, the plane of movement with the smallest relative value (worst) was identified and this plane was used for evaluating the relative change of motion subsequently. Only the plane with the worst impaired ROM at baseline was selected for subsequent analyses.|By Week 49|Range of Motion (ROM) was assessed in the ITT population.|||degrees||Standard Deviation|Mean
2582992|NCT02371369|Other Pre-specified|Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response to Pexidartinib Compared With That of Placebo Per Response Evaluation Criteria in Solid Tumors Version 1.1 by Week 49|Complete (CR) and partial responses (PR) were assessed based on centrally-read magnetic resonance imaging (MRI) scans and Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). A CR was defined as disappearance of all tumors and a PR was defined as at least a 30% decrease in the sum of diameters of target tumors using the baseline sum diameters as the reference.|By Week 49|Best overall response was assessed in the ITT population.|||Percentage of participants|||Number
2583019|NCT02370667|Secondary|Change in Isokinetic Knee Extensor and Flexor Power|The peak isokinetic torque developed during knee extension and flexion at 25% resistance of their maximum voluntary isometric contraction was measured by use of a Biodex System 2 isokinetic dynamometer. The mean (95% confidence interval) difference in power (follow-up - baseline) was computed for each of the three study arms. Data is expressed in W/kg.|Week 1 and Week 13|One participant in TE did not complete the power evaluation.|||Change in W/kg||95% Confidence Interval|Mean
2582993|NCT02371369|Secondary|Percentage of Participants Reporting Frequent (≥10%) Treatment-Emergent Adverse Events by Preferred Term|Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened after the first dose of treatment and within 28 days after the last dose. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 was used to grade adverse events. Any Grade and Grade ≥3 (severe) TEAEs are reported. TEAEs were coded using MedDRA version 17.1.|After the first dose of treatment up to 28 days after the last dose|All safety events were assessed in the Safety Analysis Set.|||Percentage of participants|||Number
2582994|NCT02371369|Secondary|Number of Responders to Pexidartinib With and Without Disease Progression Based on Tumor Volume Score by Week 120|Tumor Volume Score (TVS) is a semi-quantitative MRI scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor. The overall number of responses and the number of participants with and without disease progression was assessed.|By Week 120|The overall number of responses and the number of participants with and without disease progression was assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Pexidartinib Part 2 only; and All Pexidartinib Treated participants. Participants who received Placebo Part 1 only were not analyzed.|||participants|||Number
2582995|NCT02371369|Secondary|Number of Responders to Pexidartinib With and Without Disease Progression by Week 96|Duration of response (DOR) based on RECIST 1.1 is defined as the date of the first recorded response to the first date of documented disease progression. The overall number of responses and the number of participants with and without disease progression was assessed.|By Week 96|The overall number of responses and the number of participants with and without disease progression were assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Pexidartinib Part 2 only; and All Pexidartinib Treated participants. Participants randomized to Placebo Part 1 only were not analyzed.|||participants|||Number
2582996|NCT02371369|Secondary|Percentage of Participants Who Responded With a Decrease of at Least 30% in the Mean Brief Pain Inventory Worst Pain Numeric Rating Scale Score Among Participants Receiving Pexidartinib Compared With Those on Placebo at Week 25|"The Brief Pain Inventory (BPI) Worst Pain Numeric Rating Scale Score (NRS) was a 1-item, self-administered questionnaire assessing the worst pain in the last 24 hours. The NRS for this item ranged from 0 (no pain) to 10 (pain as bad as you can imagine)."|Week 25|Worst pain was assessed in the ITT population.|||percentage of participants|||Number
2582997|NCT02371369|Secondary|Mean Change From Baseline for Worst Stiffness Numeric Rating Scale Score (NRS) in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25|"The Worst Stiffness Numeric Rating Scale (NRS) was a 1-item, self-administered questionnaire assessing the worst stiffness in the last 24 hours. The NRS for this item ranged from 0 (no stiffness) to 10 (stiffness as bad as you can imagine)."|Baseline, Week 9, Week 17, and Week 25|Worst stiffness was assessed in the ITT population.|||units on a scale||Standard Error|Least Squares Mean
2582998|NCT02371369|Secondary|Mean Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25|The Patient-reported Outcomes Measurement Information System (PROMIS) physical function scale was used to assess physical function of the upper and lower limbs. The scale ranged from 1 defined as 'unable to do' or 'cannot do' to 5 defined as 'without any difficulty' or 'not at all', where higher scores represent better outcomes.|at Week 9 , Week 17, and Week 25|Physical function was assessed in the ITT population in participants where data were available.|||units on a scale||Standard Error|Least Squares Mean
2582999|NCT02371369|Secondary|Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response Based on Tumor Volume Score (TVS) After Receiving Pexidartinib Compared With Those on Placebo at Week 25|Complete response (CR) and partial response (PR) were assessed using tumor volume score (TVS). A CR was defined as disappearance of all tumors and a PR was defined as at least a 30% decrease in the sum of diameters of target tumors using the baseline sum diameters as the reference. TVS is a semi-quantitative MRI scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor.|Week 25|Best overall response was assessed in the ITT population.|||Percentage of participants|||Number
2583000|NCT02371369|Secondary|Mean Change From Baseline For Range of Motion (ROM) Score in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25|Range of motion (ROM) of the joint was assessed by a qualified, independent, and blinded or third-party assessors at the clinical site. Measurements were recorded in degrees. At baseline, the plane of movement with the smallest relative value (worst) was identified and this plane was used for evaluating the relative change of motion subsequently. Only the plane with the worst impaired ROM at baseline was selected for subsequent analyses.|Baseline, Week 13, and Week 25|Range of motion was assessed in the ITT population in participants where data were available.|||degrees||Standard Error|Least Squares Mean
2583001|NCT02371369|Primary|Percentage of Participants With Symptomatic, Locally Advanced Tenosynovial Giant Cell Tumor (TGCT) Achieving Complete or Partial Response to Pexidartinib Compared With That of Placebo Per Response Evaluation Criteria in Solid Tumors Version 1.1 at Week 25|Complete response (CR) and partial responses (PR) were assessed based on centrally-read magnetic resonance imaging (MRI) scans and Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). A CR was defined as disappearance of all tumors and a PR was defined as at least a 30% decrease in the sum of diameters of target tumors using the baseline sum diameters as the reference.|Week 25|Best overall response was assessed in the Intent-to-Treat (ITT) population.|||Percentage of participants|||Number
2583002|NCT02371356|Primary|Low Birth Weight|Birth weight <2500 grams|Through the end of pregnancy, an average of 40 weeks|Those with missing birth weight information were excluded from the analysis of low birth weight|||Participants|||Count of Participants
2583003|NCT02371356|Primary|Preterm Delivery|Delivery prior to 37 completed weeks of gestational age|Through the end of pregnancy, an average of 40 weeks||||Participants|||Count of Participants
2583004|NCT02371187|Primary|Change From Baseline of Fat Free Mass at Week 12|Via dual energy X-ray absorptiometry|Baseline, 12 weeks||||Kilograms||Standard Deviation|Mean
2583005|NCT02371187|Primary|Change From Baseline of Insulin Sensitivity at Week 12|Insulin Sensitivity was estimated by measuring circulating glucose and insulin concentrations after a 12-hour fast and after ingestion of 75 g of glucose. Glucose was measured 5, 10, 15, 20, 30, 45, 60, 75, 90, 105 and 120 minutes after glucose ingestion. Insulin was measured 15, 30, 45, 60, 90 and 120 minutes after glucose ingestion. Insulin sensitivity was estimated using the Matsuda Index, represented by the formula: Matsuda index = 10,000/SQRT [fasting glucose*fasting insulin* (mean glucose from time 5, 10, 15, 20, 30, 45, 60, 75, 90, 105 and 120 minutes) * (mean insulin from time 15, 30, 45, 60, 90 and 120 minutes)], with higher numbers indicating better insulin sensitivity.|Baseline, 12 weeks||||MATSUDA Index||Standard Deviation|Mean
2583006|NCT02371187|Primary|Change From Baseline of Maximal Aerobic Enzyme Activities in Skeletal Muscle at Week 12|Maximal citrate synthase activity in skeletal muscle sample|Baseline, 12 weeks||||micromol/min/miligram protein||Standard Deviation|Mean
2583007|NCT02371187|Primary|Change From Baseline of Respiratory Exchange Ratio at Week 12|The respiratory exchange ratio (RER) is the ratio between the amount of carbon dioxide (CO2) produced in metabolism and oxygen (O2) used during standardized exercise.|Baseline, 12 weeks||||Respiratory Exchange Ratio||Standard Deviation|Mean
2583008|NCT02371187|Primary|Change From Baseline of Maximal Oxygen Uptake at Week 12|Indirect calorimetry|Baseline,12 weeks||||Milliliters/Kilogram/Minute||Standard Deviation|Mean
2583009|NCT02370914|Primary|A Measure Assessing the Sensitivity and Specificity Rate Based on the Nautilus Neurowave Data|"Sensitivity (also called the true positive rate) measures the proportion of concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data. Sensitivity (also called the true negative rate) measures the proportion of non-concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data~The information that is evaluated from within this data is recognized through the computation of two parameters, R1 and R2. Both R1 and R2 are measured by computing the frequency spectrum using an FFT of the Neurowave data and computing a ratio of the signal intensities at specific higher frequencies against specific lower frequencies within that spectrum. Based on this computation, the recorded data is evaluated as coming from a concussed participant if R1 >= 1.0 and R2 >= 0.66 and is considered non-concussed otherwise."|Individual assessments were made within 2 days of recording|Analysis population includes all participants. Some of these participants were were declared concussed by the physician in the team during the course of the season. All baseline recordings were treated as from non-concussed participants.|||percentage of concussed participants||95% Confidence Interval|Number
2583010|NCT02370888|Secondary|CD34+ Mixed Chimerism|To monitor changes in the CD34+ mixed chimerism after allo-HCT in AML and MDS subjects with detectable MRD in response to escalating doses of lenalidomide.|Up to 120 days|No participant met the requirements for the efficacy population (at least 21 days of the study drug and at least one post-cycle efficacy assessment). Therefore, no data were collected for this assessment.||||||
2583011|NCT02370888|Primary|Maximum Tolerated Dose (MTD) of Lenalidomide|To determine safety and the maximum tolerated dose of lenalidomide after allo-HCT in AML and MDS subjects with MRD detected by the CD34+ mixed chimerism analysis.|Up to 72 days|Cohort requirements for analysis not met. MTD could not be assessed as only a single dose level was tested. No dose escalation was performed.||||||
2583012|NCT02370667|Secondary|Change in Inflammatory Markers (CRP)|C-reactive protein (CRP) is an important marker of the inflammatory response. This markers will be assessed using standard blood draw and nasal swabs collected by a medical professional. The mean (95% confidence interval) difference in concentration in ug/ml (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13||||Change in ug/ml||95% Confidence Interval|Mean
2583013|NCT02370667|Secondary|Change in Inflammatory Markers (IL6, TNF, IL10)|Cytokines interleukin-6 (IL6), tumour necrosis factor (TNF), and interleukin-10 (IL10) are important markers of the inflammatory response. These markers will be assessed using standard blood draw and nasal swabs collected by a medical professional. The mean (95% confidence interval) difference in concentration in pg/ml (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13|For IL10: n=6 (BE), n=8 (TE), n=6 (M)|||Change in pg/ml||95% Confidence Interval|Mean
2583014|NCT02370667|Secondary|Change in Cartilage Morphology|Cartilage morphology will be assessed in open-sourced and custom programs. Sodium (23Na+) images and T2 mapping will be completed on the 3.0T MR750 DIscovery research-grade scanner. The mean (95% confidence interval) percent change from baseline to follow-up was computed for each of the three study arms.|Week 1 and Week 13||||% Change from Baseline to Follow-up||95% Confidence Interval|Mean
2583015|NCT02370667|Secondary|Change in Muscle and Fat Volume|Muscle and fat volumes from magnetic resonance images will be segmented using a custom program. The images will be acquired using a • Iterative Decomposition of water and fat with Echo Asymmetry and Least-squares estimation (IDEAL) sequence on a 3.0T MR750 Discovery research-grade scanner.|Indented to be collected on week 1 and week 13|Data for this outcome measure were not collected.||||||
2583016|NCT02370667|Secondary|Change in Cardiovascular Fitness|Cardiovascular fitness will be calculated using the YMCA submaximal cycle ergometry test. Predictions of VO2max will be made from heart rate (measured with a heart rate monitor) and load (Watts).|Intended to be collected on week 1 and week 13|Data for this outcome measure were not collected.||||||
2583017|NCT02370667|Secondary|Change in Grip Strength (Relative)|Peak grip strength was assessed using a Jamar hand dynamometer. The hand dynamometer was set to a fixed position and all values of grip force were expressed in kg/kg (grip force/body mass). The mean (95% confidence interval) difference in relative force (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13|Note: only 9 participants were analyzed for the Left Side|||Change in kg/kg||95% Confidence Interval|Mean
2583018|NCT02370667|Secondary|Change in Grip Strength (Absolute)|Peak grip strength was assessed using a Jamar hand dynamometer. The hand dynamometer was set to a fixed position and all values of grip force were expressed in kg. The mean (95% confidence interval) difference in absolute force (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13|Note: only 9 participants were analyzed for the Left Side|||Change in kg||95% Confidence Interval|Mean
2583036|NCT02370615|Primary|Number of Participants With TEAEs Related to Vital Signs||Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.|||participants|||Number
2583022|NCT02370667|Secondary|Change in Mobility Performance (Timed Up and Go Test)|Mobility performance was measured using the Timed Up and Go Test. This test measures the time taken to rise from a standard chair with arm rests, walk 3m, and return to a seated position. This measure has produced reliable and valid data in persons with knee OA. The mean (95% confidence interval) difference in time in seconds (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13||||Change in seconds||95% Confidence Interval|Mean
2583023|NCT02370667|Secondary|Change in Mobility Performance (30-second Chair Stand Test)|Mobility performance was measured using the 30-second Chair Stand Test. This test measures the number of times participants can rise and lower from a standard height chair, without using arm rests, in a 30-second period. This measure has produced reliable and valid data in persons with knee OA. The mean (95% confidence interval) difference in number (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13||||Change in number of sit-to-stand cycles||95% Confidence Interval|Mean
2583024|NCT02370667|Secondary|Change in Mobility Performance (40m Walk Test)|Mobility performance was measured using the 40m Walk Test. This test measures the time taken to complete a fast-paced 40m walk. This measure has produced reliable and valid data in persons with knee OA. The mean (95% confidence interval) difference in time in seconds (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13||||Change in seconds||95% Confidence Interval|Mean
2583025|NCT02370667|Secondary|Change in Mobility Performance (Six-Minute Walk Test)|Mobility performance was measured using the Six-Minute Walk Test. For this test, participants are instructed to walk as far as possible in 6 minutes. The distance covered in 6 minutes is recorded. This measure has produced reliable and valid data in persons with knee OA. The mean (95% confidence interval) difference in distance in metres (follow-up - baseline) was computed for each of the three study arms.|Week 1 and Week 13||||Change in metres||95% Confidence Interval|Mean
2583026|NCT02370667|Secondary|Change in Frailty Status|Frailty was assessed using the Edmonton Frail Scale (EFS). The EFS is a brief screening interview for older adults to assess frailty that is commonly used in both inpatient and outpatient settings. The scale covers 8 domains: cognition, general health status, functional independence, social support, medication use, nutrition, mood, continence, and functional performance (defined as performance on the Timed Up and Go [TUG] test). The test is scored out of 17, with higher scores indicating higher levels of frailty. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.|Week 1 and Week 13||||Change in scores on a scale||Full Range|Mean
2583027|NCT02370667|Secondary|Change in Depression Status|Depression was assessed with the Centre of Epidemiological Studies Depression (CES-D) Scale, a 20-item scale developed for the general population with emphasis on affect. Elements of affect include mood, guilt, worthlessness, helplessness, appetite, and sleep. The CES-D is scored from 0 to 60 with a score of 16 or higher indicating depression. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.|Week 1 and Week 13||||Change in scores on a scale||95% Confidence Interval|Mean
2583028|NCT02370667|Secondary|Change in Arthritis-related Self-efficacy|The Arthritis Self-Efficacy Scale (ASES) measures arthritis-specific beliefs regarding perception of performance on certain tasks to cope with the disease. The ASES is measured using 20 questions on a 10-100 scale with respect to three main areas: pain management (5 questions), physical function (9 questions), and other symptoms (6 questions). Higher numbers indicate greater certainty that a participant can cope with a particular task as a consequence of their disease. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.|Week 1 and Week 13||||Change in scores on a scale||95% Confidence Interval|Mean
2583029|NCT02370667|Secondary|Change in Self-reported Knee Pain|Change in self-reported knee pain was assessed with 3 valid and reliable questionnaires: the Knee injury and Osteoarthritis Outcome Score (KOOS), the Intermittent and Constant Osteoarthritis Pain (ICOAP) score, and the Numeric Pain Rating Scale (NPRS). The KOOS pain score represents a normalized score from 0 (extreme symptoms) to 100 (no symptoms). KOOS scores closer to 100 indicate fewer symptoms. The ICOAP consists of two sub-scales: constant pain (5 items) and intermittent pain (6 items). The score from each subscale represents a normalized score from 0 (no pain) to 100 (extreme pain). ICOAP scores closer to 0 indicate less pain. The NPRS pain score represents a score from 0 (no pain) to 10 (worst possible pain). NPRS ratings were provided following maximum isometric knee extensor exertions and flexor exertions. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.|Week 1 and Week 13||||Change in scores on a scale||95% Confidence Interval|Mean
2583030|NCT02370667|Primary|Change in Lower Extremity Function|The Lower Extremity Function Scale (LEFS) consists of 20 items, on an adjectival scale, that assess difficulty during mobility tasks ranging from transfers to running. The LEFS is scored from 0 to 80 with higher scores represent better self-reported physical function. It is reliable and valid in knee OA and has superior sensitivity to change compared to similar measures. The mean (95% confidence interval) difference score (follow-up score - baseline score) was computed for each of the three study arms.|Week 1 and Week 13||||Change in scores on a scale||95% Confidence Interval|Mean
2583031|NCT02370641|Primary|Change in Percentage of Total Microflora Between Urolithin Excretors and Non-excretors|Difference of percentage of total microflora between urolithin excretors and non-excretors after consumption of pomegranate extract for 4 weeks|4 weeks||||percentage of total microflora||Standard Deviation|Mean
2583032|NCT02370615|Primary|Number of Participants With Clinically Significant Change From Baseline in Continuous Pulse Oximetry (SpO2) in Cohort 2||Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.|||participants|||Number
2583033|NCT02370615|Primary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis||Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.|||participants|||Number
2583034|NCT02370615|Primary|Number of Participants Who Had Clinically Significant Changes From Baseline in 12-lead Electrocardiograms|"Number of participants who had ECG findings changed from within normal limit or abnormal, clinically significant to abnormal and clinically significant after study drug administration."|Cohort 1: Baseline up to Day 19; Cohort 2: Baseline up to Day 15|The safety analysis set was defined as all participants who received at least one dose of study drug.|||participants|||Number
2583038|NCT02370615|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Midazolam and 1'Hydroxymidazolam in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 24 hours) postdose; Day 1 for Cohort 2: Midazolam and Day 7 for Cohort 2: Midazolam + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Geometric Mean
2583039|NCT02370615|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Midazolam and 1'Hydroxymidazolam in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 24 hours) postdose; Day 1 for Cohort 2: Midazolam and Day 7 for Cohort 2: Midazolam + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Geometric Mean
2583040|NCT02370615|Primary|Cmax: Maximum Observed Plasma Concentration for Midazolam and 1'Hydroxymidazolam in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 24 hours) postdose; Day 1 for Cohort 2: Midazolam and Day 7 for Cohort 2: Midazolam + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||ng/mL||Standard Deviation|Geometric Mean
2583041|NCT02370615|Primary|Urinary Excretion Ratio of Digoxin From 0 to 48 Hours Postdose in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 48 hours) postdose; Day 1 for Cohort 2: Digoxin and Day 7 for Cohort 2: Digoxin + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
2583042|NCT02370615|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Digoxin in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 48 hours) postdose; Day 1 for Cohort 2: Digoxin and Day 7 for Cohort 2: Digoxin + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Geometric Mean
2583043|NCT02370615|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Digoxin in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 48 hours) postdose; Day 1 for Cohort 2: Digoxin and Day 7 for Cohort 2: Digoxin + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Geometric Mean
2583044|NCT02370615|Primary|Cmax: Maximum Observed Plasma Concentration for Digoxin in Cohort 2||Day 1 and Day 7: pre-dose and at multiple time-points (upto 48 hours) postdose; Day 1 for Cohort 2: Digoxin and Day 7 for Cohort 2: Digoxin + TAK-272|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||ng/mL||Standard Deviation|Geometric Mean
2583045|NCT02370615|Primary|Cumulative Urinary Excretion Ratio of TAK 272F and TAK 272-M-I From 0 to 72 Hours Postdose in Cohort 1||Day 1 and Day 10: pre-dose and at multiple time-points (upto 72 hours) postdose; Day 1 for Cohort 1: TAK-272 and Day 10 for Cohort 1: TAK-272 + Itraconazole|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
2583046|NCT02370615|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK 272F and TAK 272-M-I in Cohort 1||Day 1 and Day 10: pre-dose and at multiple time-points (upto 72 hours) postdose; Day 1 for Cohort 1: TAK-272 and Day 10 for Cohort 1: TAK-272 + Itraconazole|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Geometric Mean
2583047|NCT02370615|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK 272F and TAK 272-M-I in Cohort 1||Day 1 and Day 10: pre-dose and at multiple time-points (upto 72 hours) postdose; Day 1 for Cohort 1: TAK-272 and Day 10 for Cohort 1: TAK-272 + Itraconazole|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2583048|NCT02370615|Primary|Cmax: Maximum Observed Plasma Concentration for TAK 272F and TAK 272-Metabolite (M-I) in Cohort 1||Day 1 and Day 10: pre-dose and at multiple time-points (upto 72 hours) postdose; Day 1 for Cohort 1: TAK-272 and Day 10 for Cohort 1: TAK-272 + Itraconazole|The pharmacokinetic analysis set was defined as the set of participants treated with the study drug that had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for pharmacokinetics.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2583049|NCT02370602|Secondary|Cavg During the Positron Emission Tomography (PET) Scan Period (AUC(Scan)) at 23 Hours Post-dose for TAK-063 and TAK-063 Metabolite M-I|Cavg values of TAK-063 and TAK-063 metabolite M-I during the PET scan at approximately 23 hours post TAK-063 administration. Data is not available for the pilot cohort.|23 hours post-dose|Pharmacokinetic Analysis Set|||ng/mL||Standard Deviation|Mean
2583050|NCT02370602|Secondary|AUC During the Positron Emission Tomography (PET) Scan Period (AUC(Scan)) at 23 Hours Post-dose for TAK-063 and TAK-063 Metabolite M-I|AUC values of TAK-063 and TAK-063 metabolite M-I during the PET scan at approximately 23 hours post TAK-063 administration. Data was not available for participants in the pilot cohort.|23 hours post-dose|Pharmacokinetic Analysis Set|||ng*hr/mL||Standard Deviation|Mean
2583140|NCT02370121|Primary|Triglycerides (TGs)|The blood sample for determining of TGs, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.|week 12||||mmol/L||Standard Deviation|Mean
2583052|NCT02370602|Secondary|AUC During the Positron Emission Tomography (PET) Scan Period (AUC(Scan)) at 3 Hours Post-dose for TAK-063 and TAK-063 Metabolite M-I|AUC values of TAK-063 and TAK-063 metabolite M-I during the PET scan at approximately 3 hours post TAK-063 administration.|3 hours post-dose|Pharmacokinetic Analysis Set|||ng*hr/mL||Standard Deviation|Mean
2583053|NCT02370602|Secondary|Ratio of TAK-063 Metabolite M-I AUC( 0-24) to TAK-063 AUC (0-24)|AUC Ratio is the ratio of AUC values of the metabolite compared to the parent calculated by dividing AUC values of metabolite M-I with those of the parent drug TAK-063.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set|||ratio||Standard Deviation|Mean
2583054|NCT02370602|Secondary|Ratio of TAK-063 Metabolite Cmax to TAK-063 Cmax|Cmax Ratio is the ratio of Cmax values of the metabolite compared to the parent calculated by dividing Cmax values of metabolite M-I with those of the parent drug TAK-063.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set|||ratio||Standard Deviation|Mean
2583055|NCT02370602|Secondary|CL/F: Oral Clearance of TAK-063|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by area under the curve from time 0 to 24 hours post-dose, after multiple dosing (at steady state).|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set|||liter/hour||Standard Deviation|Mean
2583056|NCT02370602|Secondary|Average Plasma Concentration on Day 1 (Cavg) for TAK-063 and TAK-063 Metabolite M-I|Cavg is the average plasma concentration on Day 1, calculated as AUC(0-24)/24.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set|||ng/mL||Standard Deviation|Mean
2583057|NCT02370602|Secondary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I|AUC(0-24) is a measure of total plasma exposure to the drug from Time 0 to 24 hours post-dose.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set|||ng*hr/mL||Standard Deviation|Mean
2583058|NCT02370602|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 Metabolite M-I|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set|||ng*hr/mL||Standard Deviation|Mean
2583059|NCT02370602|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-063 and TAK-063 Metabolite M-I|Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set|||hour||Standard Deviation|Mean
2583060|NCT02370602|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite M-I|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Pilot Cohort: Day 2 predose and at multiple time points (up to 24 hours) post-dose. Main Cohort: Day 1 predose and at multiple time points (up to 24 hours) post-dose.|Pharmacokinetic Analysis Set|||ng/mL||Standard Deviation|Mean
2583061|NCT02370602|Secondary|Percentage of Participants With Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters|"The percentage of participants with any markedly abnormal standard 12-lead ECG measurements.~QTc - Bazett's Interval (msec) is ≥500 msec OR ≥30 msec change from Baseline and ≥450 msec"|From Day 1 to Day 16|Safety analysis set included all participants who received at least one dose of study drug.|||percentage of participants|||Number
2583062|NCT02370602|Secondary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study. BL=baseline. bpm=beats per minute.|From Day 1 to Day 16|Safety analysis set included all participants who received at least one dose of study drug.|||percentage of participants|||Number
2583063|NCT02370602|Secondary|Percentage of Participants With Markedly Abnormal Safety Laboratory Findings|The percentage of participants with any markedly abnormal standard safety laboratory values was collected throughout study.|From Day 1 to Day 16|Safety analysis set included all participants who received at least one dose of study drug.|||percentage of participants|||Number
2583064|NCT02370602|Secondary|Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug to 30 days after last dose of study drug (up to 46 days)|Safety analysis set included all participants who received at least one dose of study drug.|||percentage of participants|||Number
2583065|NCT02370602|Secondary|Phosphodiesterase 10A (PDE10A) Occupancy of Brain Regions With [^11C]T-773 at 23 Hours Following a Single Dose of TAK-063|Volume of tissue distribution (Vt) values will be estimated by several quantitative methods for each positron emission tomography (PET) scan. Based on the change in Vt before and after TAK-063 administration, PDE10A occupancy will be calculated. PET scan #2 in the Pilot Cohort and PET scan #1 in the Main Cohort will be used as a baseline for the occupancy calculation. Data was not available for participants in the pilot cohort. Occupancy is reported for putamen only.|23 hours post-dose|Pharmacodynamic Analysis Set includes all participants with data available for pharmacodynamic analysis.|||Percent||Standard Deviation|Mean
2583275|NCT02369172|Primary|Peak Plasma Concentration (Cmax) of Bupropion||prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2583066|NCT02370602|Primary|Phosphodiesterase 10A (PDE10A) Occupancy of Brain Regions With [^11C]T-773 at 3 Hours Following a Single Dose of TAK-063|Volume of tissue distribution (Vt) values will be estimated by several quantitative methods for each positron emission tomography (PET) scan. Based on the change in Vt before and after TAK-063 administration, PDE10A occupancy will be calculated. PET scan #2 in the Pilot Cohort and PET scan #1 in the Main Cohort will be used as a baseline for the occupancy calculation. Occupancy is reported for putamen only.|3 hours post-dose|Pharmacodynamic Analysis Set includes all participants with data available for pharmacodynamic analysis..|||Percent||Standard Deviation|Mean
2583067|NCT02370537|Primary|Part B: Baseline Corrected Cmax for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®.|Baseline corrected Cmax was measured for the sum of EPA and DHA (total EPA+DHA) following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations.|||nmol/mL||Geometric Coefficient of Variation|Geometric Mean
2583068|NCT02370537|Primary|Part B: Baseline Corrected Cmax for Total DHA Following Administration of EPANOVA® and OMACOR®.|Baseline corrected Cmax was measured for total DHA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2583069|NCT02370537|Primary|Part B: Baseline Corrected Maximum Plasma Drug Concentration (Cmax) for Total EPA Following Administration of EPANOVA® and OMACOR®.|Baseline corrected Cmax was measured for total EPA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any important protocol deviations.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2583070|NCT02370537|Primary|Part B: Baseline Corrected AUC(0-last) for Total EPA+DHA Following Administration of EPANOVA® and OMACOR®.|Baseline corrected AUC(0-last) was measured for the sum of EPA and DHA (total EPA+DHA) following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations. 3 subjects were excluded from the analysis for AUC(0-last) due to missing sample results at 48 hours.|||h*nanomole/mL (h*nmol/mL)||Geometric Coefficient of Variation|Geometric Mean
2583071|NCT02370537|Primary|Part B: Baseline Corrected AUC(0-last) for Total Docosahexaenoic Acid (DHA) Following Administration of EPANOVA® and OMACOR®.|Baseline corrected AUC(0-last) was measured for total DHA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The PK Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any protocol deviations. 3 subjects were excluded from the analysis for AUC(0-last) due to missing sample results at 48 hours.|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2583072|NCT02370537|Primary|Part B: Baseline Corrected Area Under the Plasma Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) for Total Eicosapentaenoic Acid (EPA) Following Administration of EPANOVA® and OMACOR®.|Baseline corrected AUC(0-last) was measured for total EPA following administration of single oral doses of EPANOVA® 4 g (A) and OMACOR® 4 g (B) (2-way crossover design) to patients with T2DM and different degrees of PEI.|Blood samples for analysis were taken at 1, 0.5, and 0.05 hours pre-dose, to be used as baseline, and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 24 and 48 hours post-dose.|The Pharmacokinetic (PK) Analysis Set included all randomised patients who received at least one dose of study treatment in Part B and had at least one post-dose PK measurement without any important protocol deviations. 3 subjects were excluded from the analysis for AUC(0-last) due to missing sample results at 48 hours.|||hours*mcg per millilitre (h*mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2583073|NCT02370537|Primary|Part A: Serum TG Level.|For Part A, the distribution of serum TG levels by the degree of pancreatic exocrine insufficiency (PEI) was assessed in patients with Type 2 Diabetes Mellitus (T2DM).|7 days after enrollment.|The Per Protocol Analysis Set included all enrolled patients without an important protocol deviation.|||millimole per litre (mmol/L)||Standard Deviation|Mean
2583074|NCT02370498|Secondary|Percentage of All Participants That Discontinued Study Treatment Due to AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that discontinued study treatment due to an AE was reported for all participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
2583399|NCT02367794|Secondary|PFS as Determined by the Investigator Using RECIST v1.1 in the Tumor Cell (TC) 2/3 or Tumor-Infiltrating Immune Cell (IC) 2/3 Population||Up to approximately 30 months after first participant enrolled||2020-10-31|10/2020||||
2583075|NCT02370498|Secondary|Percentage of PD-L1 Positive Participants That Discontinued Study Treatment Due to AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that discontinued study treatment due to an AE was reported for PD-L1 positive participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized PD-L1 positive participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
2583076|NCT02370498|Secondary|Percentage of All Participants Who Experienced an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants with at least one AE was reported for all participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
2583077|NCT02370498|Secondary|Percentage of PD-L1 Positive Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants with at least one AE was reported for PD-L1 positive participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized PD-L1 positive participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
2583078|NCT02370498|Secondary|DOR According to RECIST 1.1 Based on Investigator Assessment in All Participants|For participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for all participants with response by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|The subset of all randomized participants that showed a CR or PR according to RECIST 1.1 and based on investigator assessment. Participants were included in the treatment group to which they were randomized.|||months||Full Range|Median
2583079|NCT02370498|Secondary|DOR According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants|For PD-L1 positive participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for PD-L1 positive participants with response by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|The subset of all randomized PD-L1 positive participants that showed a CR or PR according to RECIST 1.1 and based on investigator assessment. Participants were included in the treatment group to which they were randomized.|||months||Full Range|Median
2583080|NCT02370498|Secondary|DOR According to RECIST 1.1 Based on BICR in All Participants|For participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for all participants with response by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|The subset of all randomized participants that showed a CR or PR according to RECIST 1.1 and based on BICR. Participants were included in the treatment group to which they were randomized.|||months||Full Range|Median
2583081|NCT02370498|Secondary|Duration of Response (DOR) According to RECIST 1.1 Based on BICR in PD-L1 Positive Participants|For PD-L1 positive participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for PD-L1 positive participants with response by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|The subset of all randomized PD-L1 positive participants that showed a CR or PR according to RECIST 1.1 and based on BICR. Participants were included in the treatment group to which they were randomized.|||months||Full Range|Median
2583400|NCT02367794|Secondary|PFS as Determined by the Investigator Using RECIST v1.1 in the tGE Population||Up to approximately 30 months after first participant enrolled||2020-10-31|10/2020||||
2583082|NCT02370498|Secondary|ORR According to RECIST 1.1 Based on Investigator Assessment in All Participants|ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for all participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized participants. Participants were included in the treatment group to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2583083|NCT02370498|Secondary|ORR According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants|ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for PD-L1 positive participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2583084|NCT02370498|Secondary|ORR According to RECIST 1.1 Based on BICR in All Participants|ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for all participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized participants. Participants were included in the treatment group to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2583085|NCT02370498|Secondary|Objective Response Rate (ORR) According to RECIST 1.1 Based on BICR in PD-L1 Positive Participants|ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for PD-L1 positive participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2583086|NCT02370498|Secondary|TTP According to RECIST 1.1 Based on Investigator Assessment in All Participants|TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for all participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized participants. Participants were included in the treatment group to which they were randomized.|||months||95% Confidence Interval|Median
2583087|NCT02370498|Secondary|TTP According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants|TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for PD-L1 positive participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.|||months||95% Confidence Interval|Median
2583088|NCT02370498|Secondary|TTP According to RECIST 1.1 Based on BICR in All Participants|TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for all participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized participants. Participants were included in the treatment group to which they were randomized.|||months||95% Confidence Interval|Median
2583089|NCT02370498|Secondary|Time to Tumor Progression (TTP) According to RECIST 1.1 Based on BICR in PD-L1 Positive Participants|TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for PD-L1 positive participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.|||months||95% Confidence Interval|Median
2583098|NCT02370420|Secondary|Change in the Visual Analog Scale (VAS) (Global Pain)|"The Visual Analog Scale (VAS) is a unidimensional measure of pain intensity. The scale is most commonly anchored by no pain  (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10).~Only the final measures (at 24 weeks) are presented as part of the final analysis."|Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks||||cm||Standard Deviation|Mean
2583401|NCT02367794|Secondary|OS in the Tumor Gene Expression (tGE) Population||Up to approximately 39 months after first participant enrolled||2020-10-31|10/2020||||
2583090|NCT02370498|Secondary|PFS According to irRECIST Based on BICR in All Participants|PFS defined as time from randomization to first documented PD per irRECIST based on BICR, or death due to any cause, whichever occurs first. Following initial PD by RECIST 1.1 (20% relative increase in SOD of target lesions), participants were assessed according to irRECIST: tumor assessment was repeated ≥4 weeks later to confirm PD with the option of continuing treatment until this scan was obtained for clinically stable participants. If PD confirmed, participant was discontinued from treatment unless investigator determined benefit. If repeat scan indicated SD (neither sufficient shrinkage or increase of target lesion), PR (≥30% decrease in the SOD of target lesions), or CR (disappearance of all non-nodal target lesions), participant could continue treatment at investigator's discretion. PFS analyzed using Kaplan-Meier method and median PFS (95% CI) in months was reported for PD-L1 positive participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized participants. Participants were included in the treatment group to which they were randomized.|||months||95% Confidence Interval|Median
2583091|NCT02370498|Secondary|PFS According to Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) Based on BICR in PD-L1 Positive Participants|PFS defined as time from randomization to first documented PD per irRECIST based on BICR, or death due to any cause, whichever occurs first. Following initial PD by RECIST 1.1 (20% relative increase in SOD of target lesions), participants were assessed according to irRECIST: tumor assessment was repeated ≥4 weeks later to confirm PD with the option of continuing treatment until this scan was obtained for clinically stable participants. If PD confirmed, participant was discontinued from treatment unless investigator determined benefit. If repeat scan indicated stable disease (SD; neither sufficient shrinkage or increase of target lesion), partial response (PR; ≥30% decrease in the SOD of target lesions), or complete response (CR; disappearance of all non-nodal target lesions), participant could continue treatment at investigator's discretion. PFS analyzed using Kaplan-Meier method and median PFS (95% CI) in months was reported for PD-L1 positive participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.|||months||95% Confidence Interval|Median
2583092|NCT02370498|Secondary|PFS According to RECIST 1.1 Based on Investigator Assessment in All Participants|PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first. According to RECIST 1.1, PD was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% CI) in months was reported for all participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized participants. Participants were included in the treatment group to which they were randomized.|||months||95% Confidence Interval|Median
2583093|NCT02370498|Secondary|PFS According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants|PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first. According to RECIST 1.1, PD was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% CI) in months was reported for PD-L1 positive participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.|||months||95% Confidence Interval|Median
2583094|NCT02370498|Secondary|OS in All Participants|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was analyzed using the Kaplan-Meier method and median OS (95% CI) in months was reported for all participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized participants. Participants were included in the treatment group to which they were randomized.|||months||95% Confidence Interval|Median
2583095|NCT02370498|Secondary|PFS According to RECIST 1.1 Based on BICR in All Participants|PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs first. According to RECIST 1.1, PD was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% CI) in months was reported for all participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized participants. Participants were included in the treatment group to which they were randomized.|||months||95% Confidence Interval|Median
2583096|NCT02370498|Primary|Overall Survival (OS) in PD-L1 Positive Participants|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was analyzed using the Kaplan-Meier method and median OS (95% CI) in months was reported for PD-L1 positive participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.|||months||95% Confidence Interval|Median
2583097|NCT02370498|Primary|Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants|PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs first. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% confidence interval [CI]) in months was reported for PD-L1 positive participants by treatment group.|Up to 30 months (through database cut-off date of 26 Oct 2017)|All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized.|||months||95% Confidence Interval|Median
2583596|NCT02366468|Secondary|Mean Change in Central Subfield Retinal Thickness (CSRT)|Evaluated by central reading center assessing OCT images|Baseline to Month 12|FAS - Last Observation Carried Forward (LOCF)|||μm||Standard Deviation|Mean
2583099|NCT02370420|Secondary|Change in the SF-12 Health Survey (Quality of Life)|"SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life.~A higher value indicates a better quality of life of the patient. The scores range from 0 to 100. The data obtained with the SF-12 has been developed, tested and validated by Quality Metric Incorporated.~Only the final measures (at 24 weeks) from the physical domain are presented as part of the final analysis."|Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks||||units on a scale||Standard Deviation|Mean
2583100|NCT02370420|Primary|Change in the Western Ontario and McMaster Universities (WOMAC) Ostearthritis Index (Therapeutic Effect)|"The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. It measures five items of pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68); thus, the total score range is 0-96. A higher value indicates a worst outcome.~Only the final measures (at 24 weeks) are presented as part of the final analysis."|Baseline,3 weeks, 6 weeks, 12 weeks, 24 weeks||||units on a scale||Standard Deviation|Mean
2583101|NCT02370407|Secondary|Workspace Range|Automatically recorded data on the Mimic DV trainer consisting of workspace range (cm, this is the widest range traveled by the 2 instruments, one in each hand), and number of peg drops|study duration||||cm||Standard Deviation|Mean
2583102|NCT02370407|Secondary|Time Spent Using Excessive Force|Automatically recorded data on the Mimic DV trainer (seconds)|study duration||||seconds||Standard Deviation|Mean
2583103|NCT02370407|Secondary|Instrument Collisions|Automatically recorded data on the Mimic DV trainer which records number of collisions|study duration||||number of events||Standard Deviation|Mean
2583104|NCT02370407|Secondary|Instrument Out of View|Automatically recorded data on the Mimic DV trainer, (sec). The longer out of view indicates decreased proficiency|through study completion||||seconds||Standard Deviation|Mean
2583105|NCT02370407|Secondary|Economy of Motion on the Robotic Task|(cm, where lower measurements represent improved economy of motion). This measures how many cm the instruments traveled in order to accomplish the task|Study duration||||cm||Standard Deviation|Mean
2583106|NCT02370407|Primary|Time to Task Completion on the Laparoscopic Task|Time to task completion (seconds) on the laparoscopic task|1 day of practice||||seconds||Standard Deviation|Mean
2583107|NCT02370407|Primary|Global Rating Scale Score on the Robotic Task|A composite score of (1) depth perception, (2) bimanual dexterity, (3) efficiency, (4) tissue handling, (5) time and motion, (6) instrument handling, and (7) flow of operation, each scored 1 through 5 on an anchored Likert scale where higher scores indicated improved proficiency. Point range 7 - 35.|Study duration||||units on a scale||Standard Deviation|Mean
2583108|NCT02370407|Primary|Global Rating Scale Score on the Laparoscopic Task|Global rating scale score on the laparoscopic task. A composite score of (1) depth perception, (2) bimanual dexterity, (3) efficiency, (4) tissue handling, (5) time and motion, (6) instrument handling, and (7) flow of operation, each scored 1 through 5 on an anchored Likert scale where higher scores indicated improved proficiency. Point range 7 - 35.|Study duration||||units on a scale||Standard Deviation|Mean
2583109|NCT02370407|Primary|Time to Task Completion (Robotic Task)|Primary outcome will be time to task completion (seconds) on the robotic task|1 day of practice||||seconds||Standard Deviation|Mean
2583110|NCT02370394|Secondary|The Readiness to Change Contemplation Ladder|One item measure to assess readiness to make changes to increase safety. This item was scored with a range from 0-10. 0=not prepared to change to 10=already changing. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more ready to make changes to increase safety.|Assessed at baseline, and again three months later|The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.|||units on a scale||Standard Deviation|Mean
2583111|NCT02370394|Secondary|Motivation Scale|A 1-item measure, was modified to assess how ready they are to use treatment, resources, and/or support for any partner abuse. This item was scored with a range from 0-10. 0=not ready at all to 10=completely ready. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more ready to use treatment, resources, or support for any partner abuse.|Assessed at baseline, and again three months later|The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.|||units on a scale||Standard Deviation|Mean
2583112|NCT02370394|Primary|Effectiveness in Obtaining Resources Scale (EOR)|Assesses the women's effectiveness in obtaining resources from 11 different types of community resources including mental health treatment, church or clergy, health care, legal services, police, or social services. Items were scored as Yes=1 or No=0. Scale range is from 0-11. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more they were effective in obtaining resources.|Assessed at baseline, and again three months later|The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.|||units on a scale||Standard Deviation|Mean
2583113|NCT02370394|Primary|Safety Behavior Checklist (SBC)|Includes 15 items that assess the use of strategies suggested to keep victim safe (e.g., hiding money and extra clothing). Items were scored as Yes=1 or No=0 or Not applicable. Scale range is from 0-15. Mean score was used to calculate differences between baseline and follow-up and between groups. The higher the score, the better or more use of safety behaviors.|Assessed at baseline, and again three months later|The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.|||units on a scale||Standard Deviation|Mean
2583137|NCT02370121|Primary|Systolic Blood Pressure (SBP)|The SBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of SBP. The value was expressed on mmHg.|week 12||||mmHg||Standard Deviation|Mean
2583114|NCT02370394|Primary|Composite Abuse Scale (CAS)-CAS Victimization Total Score|A widely used self-report of behaviors that includes a 36-item scale - only the CAS Victimization Total score was calculated. Items were scored between 0 and 5, with Never=0 and Daily=5. Scale range is from 0-180. Mean score was used to calculate differences between baseline and follow-up and between groups. The lower the score, the better or less victimization.|Assessed at baseline, and again three months later|The number of participants analyzed differs from baseline to follow-up because 2 dropped out of the ROSE intervention group, and 1 dropped out and 1 withdrew (no longer interested) from the control condition.|||units on a scale||Standard Deviation|Mean
2583115|NCT02370251|Secondary|Essential Fatty Acid Deficiency in Infants Who Received Omegaven|To determine if Omegaven can resolve essential fatty acid deficiency|Within the first month of use||||Participants|||Count of Participants
2583116|NCT02370251|Secondary|Safety Issues for Infants Who Received Omegaven|To determine if Omegaven results in safety issues such as increased bleeding, essential fatty acid deficiency, elevated liver function tests, increased liver and/or intestinal transplant rates, or death|Within the first year of use||||Participants|||Count of Participants
2583117|NCT02370251|Primary|Resolution of Cholestasis for Subjects Who Received Omegaven|To determine if Omegaven results in the resolution of cholestasis (DB <2 for 2 consecutive weeks)|Within the first 3 months of sole Omegaven use||||Participants|||Count of Participants
2583118|NCT02370160|Secondary|Time to Relapse/Progression||1 year||||days||Full Range|Mean
2583119|NCT02370160|Secondary|Overall Survival||1 year||||Participants|||Count of Participants
2583120|NCT02370160|Secondary|Disease-free Survival||1 year||||Participants|||Count of Participants
2583121|NCT02370160|Secondary|Phase II : Duration of Response|Duration of response was calculated as duration between on-study date and best response date for those patients who achieved complete remission (CR) or partial response (PR)|1 year|Only 2 participants achieved CR or PR|||days||Full Range|Median
2583122|NCT02370160|Secondary|Incidence of Serious Adverse Events|"A Serious Adverse Event is defined as an adverse event that results in any of the following outcomes:~Death~A life-threatening adverse event~Inpatient hospitalization or prolongation of existing hospitalization~A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions~A congenital anomaly/birth defect.~Important medical event"|Day 29||||events|||Number
2583123|NCT02370160|Primary|Phase ll: Overall Disease Response|"Response is defined as complete response, partial response and stable disease. Complete response is defined as the disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured.~Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.~Stable disease is defined as cancer that is neither decreasing nor increasing in extent or severity."|Day 29|12 Subjects treated on dose level 1: 4 achieved stable disease and 1 had partial response|||Participants|||Count of Participants
2583124|NCT02370160|Primary|Phase I: Incidence of Any DLT Attributed to DT2219 in the First Cycle|"Dose limiting toxicity (DLT) is defined as any of the following adverse events occurring from study day 1 through 7 days after the last dose of DT2219 of the 1st treatment cycle, and not clearly attributed to the primary malignancy or intercurrent illness:~any Grade 5 adverse event~any Grade 4 neutropenia or thrombocytopenia lasting more for than 7 days~any Grade 3 thrombocytopenia with bleeding~any Grade 4 non-hematologic adverse event during DT2219 infusion~any Grade 3 non-hematologic adverse event occurring after completion of DT2219 infusion"|Day 1 - Day 29||||events|||Number
2583125|NCT02370121|Secondary|Area Under the Curve of Insulin (AUCI)|The estimation for AUCI was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed on pmol/L/min.|week 12||||pmol/L/min||Standard Deviation|Mean
2583126|NCT02370121|Secondary|Area Under the Curve of Glucose (AUCG)|The estimation for AUCG was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed mmol/L/min.|week 12||||mmol/L/min||Standard Deviation|Mean
2583127|NCT02370121|Secondary|2-hour Postload Plasma Glucose (2-h PG)|The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.|week 12||||mmol/L||Standard Deviation|Mean
2583128|NCT02370121|Secondary|Very-low Density Lipoprotein (VLDL)|The blood sample for determining the VLDL, was taken after an overnight fast and was calculated as triglycerides/5. The value was expressed on mmol/L.|week 12||||mmol/L||Standard Deviation|Mean
2583129|NCT02370121|Secondary|Low-density Lipoprotein Cholesterol (LDL-C)|The blood sample for determining of LDL-C, was taken after an overnight fast and was calculated by Friedewald formula. The value was expressed on mmol/L.|Week 12||||mmol/L||Standard Deviation|Mean
2583130|NCT02370121|Secondary|Total Cholesterol (TC)|The blood sample for determining of TC, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.|week 12||||mmol/L||Standard Deviation|Mean
2583131|NCT02370121|Secondary|Body Mass Index (BMI)|The BMI was calculated by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.|week 12||||kg/m^2||Standard Deviation|Mean
2583132|NCT02370121|Secondary|Body Weight (BW)|The BW was evaluated after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.|week 12||||kg||Standard Deviation|Mean
2583133|NCT02370121|Primary|Insulin Sensitivity|The insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)].|week 12||||unitless||Standard Deviation|Mean
2583134|NCT02370121|Primary|First Phase of Insulin Secretion|The first phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0').|week 12||||unitless||Standard Deviation|Mean
2583135|NCT02370121|Primary|Total Insulin Secretion|The total insulin secretion was calculated by the insulinogenic index (ΔABC insulin / ΔABC glucose).|Week 12||||unitless||Standard Deviation|Mean
2583136|NCT02370121|Primary|Diastolic Blood Pressure (DBP)|The DBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of DBP. The value was expressed on mmHg.|week 12||||mmHg||Standard Deviation|Mean
2583141|NCT02370121|Primary|Waist Circumference (WC)|The WC was evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.|Week 12|All participants, including those who dropped out before the end were taken into account for statical analysis (intention to treat).|||cm||Standard Deviation|Mean
2583142|NCT02370095|Secondary|Number of Days From Study Enrollment Until Mechanical Ventilation is Required|Time to intubation and mechanical ventilation|Day 0 to day 28|Intent to Treat|||days||Standard Deviation|Mean
2583143|NCT02370095|Secondary|Peak Plasma Concentration Determined 15 Min After Inhalation and Trough Determined 4 Hours Following the Drug/Placebo Administration|Treprostinil Plasma Concentration|Day 3|Only 3 plasma pharmacokinetic samples were collected from subjects treated with Treprostinil and therefore no measurements of plasma Treprostinil were made.||||||
2583144|NCT02370095|Secondary|Number of Deaths During Hospitalization|Hospital Mortality|Deaths during hospitalization (up to 3 months)|Intent to Treat|||Participants|||Count of Participants
2583145|NCT02370095|Secondary|Number of Subjects Requiring Intubation and Mechanical Ventilation|Intubation / Mechanical Ventilation|0-28 days|Intent to treat|||Participants|||Count of Participants
2583146|NCT02370095|Secondary|All-cause Mortality|All-cause mortality|0-28 days||||Participants|||Count of Participants
2583147|NCT02370095|Secondary|Change in Mean Arterial Pressure (MAP).|MAP|Change in MAP from Day 0 to day 7|Intent to Treat|||mm Hg||Standard Deviation|Mean
2583148|NCT02370095|Secondary|Change in Central Venous Pressure (CVP).|CVP|Change in CVP from Day 0 to 3 (if central venous catheter in place)|A central venous line was not in place for the subjects so measurements could not be obtained||||||
2583149|NCT02370095|Secondary|Change in the Central Venous Oxygen Saturation (SCVO2).|SCVO2|Change in SCVO2 from Day 0 to 3 (if central venous catheter in place)|None of the patients had a central venous line, so no samples were obtained for analysis.||||||
2583150|NCT02370095|Secondary|Acute Respiratory Distress Syndrome (ARDS) Associated Biomarkers|Change in ARDS associated plasma biomarkers|Change from day 0 on days 3 and 7|Too few samples were collected at the designated days 3 and 7 to provide informative data. Plasma samples were not analyzed.||||||
2583151|NCT02370095|Secondary|Number of Subjects Who Required Bi-level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) Via Face Mask|BiPAP / CPAP|0-28 days|Intent to treat|||Participants|||Count of Participants
2583152|NCT02370095|Secondary|Number of Days Not on a Ventilator|Ventilator-free days|0-28 days post enrollment||||days||Standard Deviation|Mean
2583153|NCT02370095|Secondary|Change in the Ratio of Peripheral Oxygen Saturation to Fraction of Inspired Oxygen (SaO2/FiO2)|SaO2/FiO2|0-12 days|Intent to treat|||S/F ratio||Standard Error|Least Squares Mean
2583154|NCT02370095|Primary|Change in the Ratio of the Partial Pressure of Arterial Oxygen to the Fraction of Inspired Oxygen (PaO2/FiO2 Ratio)|PaO2/FiO2 ratio|Change in PaO2/FiO2 ratio from day 0 to day 2.|Determination of this endpoint was dependent on subject consent for collection of an arterial blood sample. A baseline measure was obtained from thirteen subjects. Samples were obtained from seven subjects at day 2, and two subjects at day 7 and none at day 28. Analysis was limited to change from baseline to day 2.|||P/F ratio||Standard Error|Mean
2583155|NCT02370043|Secondary|Renal Clearance (Clr)|Calculated by the following equation: Ae0-t/AUC0-24|Four hour intervals up to 12 hours, and then 12-24 hours post dose|All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Clr.|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2583156|NCT02370043|Secondary|Time of Rmax Urinary Excretion (TRmax)||Four hour intervals up to 12 hours, and then 12-24 hours post dose|All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute TRmax.|||Hours||Full Range|Median
2583157|NCT02370043|Secondary|Maximum Rate of Urinary Excretion (Rmax)||Four hour intervals up to 12 hours, and then 12-24 hours post dose|All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Rmax.|||μg/hour||Geometric Coefficient of Variation|Geometric Mean
2583158|NCT02370043|Secondary|Cumulative Urinary Excretion From Time Zero to Time t (Ae0-t)||Four hour intervals up to 12 hours, and then 12-24 hours post dose|All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Ae0-t.|||μg||Geometric Coefficient of Variation|Geometric Mean
2583159|NCT02370043|Secondary|Amount of Drug Excreted in Urine||Four hour intervals up to 12 hours, and then 12-24 hours post dose|All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute the Amount of Drug Excreted in Urine.|||μg||Geometric Coefficient of Variation|Geometric Mean
2583160|NCT02370043|Secondary|Time to Maximum Drug Concentration (Tmax) in Fed Versus Fasting State||Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels||||Hours||Full Range|Median
2583161|NCT02370043|Secondary|Maximum Observed Drug Concentration (Cmax) in Fed Versus Fasting State||Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2583162|NCT02370043|Secondary|Area Under the Concentration-time Curve From Time Zero to the Last Non-Zero Concentration (AUC0-t) in Fed Versus Fasting State||Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2583163|NCT02370043|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) in Fed Versus Fasting State||Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg|All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute AUC0-inf in Fed versus Fasting State.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2583462|NCT02367352|Primary|Dose Expansion Phase: Tmax: Time to Reach the Maximum Plasma Concentration of Paclitaxel||Day 1 predose and Day 1, 2, and 3 at multiple time points (up to 12 hours) post-dose|The dose expansion phase was cancelled by the sponsor.||||||
2583164|NCT02370043|Secondary|Apparent Volume of Distribution (Vd/F)||Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg|All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Vd/F.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2583165|NCT02370043|Secondary|Apparent Body Clearance (Cl/F)||Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg|All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute CI/F.|||Liters per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2583166|NCT02370043|Secondary|Elimination Rate Constant (Kel)||Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg|All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Kel.|||Per hour||Geometric Coefficient of Variation|Geometric Mean
2583167|NCT02370043|Secondary|Elimination Half-Life (T1/2 el)||Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg|All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute T1/2 el.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2583168|NCT02370043|Secondary|Time to Observed Cmax (Tmax)||Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels|All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Tmax.|||Hours||Full Range|Median
2583169|NCT02370043|Secondary|Residual Area|calculated as 100*(1- AUC0-t / AUC0-inf)|Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg|All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Residual Area.|||Percentage residual area under the AUC||Geometric Coefficient of Variation|Geometric Mean
2583170|NCT02370043|Secondary|Maximum Observed Drug Concentration (Cmax)||Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg|All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute Cmax.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2583171|NCT02370043|Secondary|Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf)||Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg'|All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute AUC0-inf.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2583172|NCT02370043|Secondary|Area Under the Concentration-Time Curve From Time Zero to 24-hour Post-Dose (AUC0-24)||Pre-dose and 0.5, 1, 2, 4, 6, 8,10, and 24 hours post-dose|All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute AUC0-24.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2583173|NCT02370043|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Non-Zero Concentration (AUC0-t)||Pre-dose and 0.5, 1, 2, 4, 6, 8,10, 24, 48, 96, and 144 hours post-dose, and on Day 10 for all dose levels, and on Day 28 for dose level 195 mg; on Days 14 and 28 for dose level 600 mg; and on Days 14, 28, and 56 for dose level 1800 mg|All randomized participants who received at least 1 dose of KQ-791and had sufficient evaluable PK data to compute AUC0-t.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2583174|NCT02370043|Primary|Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug||Baseline to study completion (up to 11 weeks)||||participants|||Number
2583175|NCT02369874|Secondary|Number of Participants Reporting One or More Adverse Events (AE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Inclusive of AEs and serious AEs.|First dose to last dose + 90 days or data cut off (up to 36 months)|Safety analysis set - inclusive of all participants that received at least 1 dose of study treatment.|||Participants|||Count of Participants
2583176|NCT02369874|Secondary|Time to Deterioration for European Organisation for Research and Treatment of Cancer 35-item Head and Neck Quality of Life Questionnaire (EORTC QLQ-H&N35)|The EORTC QLQ-H&N35 comprises of 35 questions to assess head and neck cancer symptoms (e.g. pain, swallowing). Deterioration was defined as a 10-point increase from baseline in the symptom score.|September 2015 to September 2018 (36 months)|All randomized patients who provided questionnaire data|||Months||95% Confidence Interval|Median
2583177|NCT02369874|Secondary|Time to Deterioration in European Organisation for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire, Version 3 (EORTC QLQ-C30)|The EORTC QLQ-C30 consists of 30 questions that can be combined to produce functional scales (e.g. physical), symptom scales (e.g. fatigue), and a global measure of health status. Each of the scales are measured from 0 to 100. Deterioration was defined as a 10-point decrease from baseline in a functioning or global health status/ quality of life score or a 10-point increase from baseline in a symptom score.|September 2015 to September 2018 (36 months)|All randomized patients who provided questionnaire data|||Months||95% Confidence Interval|Median
2583188|NCT02369874|Primary|Overall Survival (OS)|OS is defined as the time from the date of randomization until death due to any cause. OS was analyzed for the full analysis set, regardless of programmed death-ligand 1 (PD-L1) status.|September 2015 to September 2018 (36 months)|Full analysis set - inclusive of all randomized participants.|||Months||95% Confidence Interval|Median
2583463|NCT02367352|Primary|Dose Expansion Phase: Cmax: Maximum Observed Plasma Concentration of Paclitaxel||Day 1 predose and Day 1, 2, and 3 at multiple time points (up to 12 hours) post-dose|The dose expansion phase was cancelled by the sponsor.||||||
2583178|NCT02369874|Secondary|Objective Response Rate (ORR) in PD-L1 Negative Participants|The percentage of PD-L1 negative participants who experienced an objective response (complete response [CR] or partial response [PR]), based on investigator assessments according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). A CR was defined as the disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm. A PR was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters. PD-L1 negative was defined as <25% of tumor cells with membrane staining for PD-L1 at any intensity.|September 2015 to September 2018 (36 months)|PD-L1-negative analysis set - inclusive of all randomized participants whose PD-L1 status is PD-L1-negative as defined by the Ventana PD-L1 SP263 IHC assay.|||Percentage of participants||95% Confidence Interval|Number
2583179|NCT02369874|Secondary|Progression Free Survival (PFS) in PD-L1 Negative Participants|Number of participants with confirmed objective disease progression (PD) at the time of the participant's last evaluable response evaluation criteria in solid tumors 1.1 (RECIST1.1) assessment. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PD-L1 negative was defined as <25% of tumor cells with membrane staining for PD-L1 at any intensity.|September 2015 to September 2018 (36 months)|PD-L1-negative analysis set - inclusive of all randomized participants whose PD-L1 status is PD-L1-negative as defined by the Ventana PD-L1 SP263 IHC assay.|||Participants|||Count of Participants
2583180|NCT02369874|Secondary|Percentage of Participants Alive|Percentage of participants alive at 12, 18 and 24 months using a Kaplan Meier estimate.|12, 18 and 24 months|Full analysis set - inclusive of all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2583181|NCT02369874|Secondary|Percentage of Participants Alive and Progression Free (APF)|APF is defined as the percentage of participants who are alive and progression free at 6 months and 12 months after randomization. Estimates of progression free survival were based on investigator assessments according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). Objective disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline up to 6 months; baseline up to 12 months|Full analysis set - inclusive of all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2583182|NCT02369874|Secondary|Disease Control Rate (DCR)|"6 Months: The percentage of participants who had a best objective response of complete response (CR) or partial response (PR) in the first 6 months or had demonstrated stable disease (SD) for a minimum interval of 24 weeks following randomization.~12 Months: The percentage of participants who had a best objective response of CR or PR within 12 months or had demonstrated SD for a minimum interval of 48 weeks following randomization.~Objective response was based on investigator assessments, according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). A CR was defined as the disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm. A PR was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters."|Baseline up to 6 months; baseline up to 12 months|Full analysis set - inclusive of all randomized participants.|||Percentage of participants|||Number
2583183|NCT02369874|Secondary|Duration of Response (DoR)|Median DoR, in months, based on investigator assessments, according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). A complete response was defined as the disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm. A partial response was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters.|September 2015 to September 2018 (36 months)|Full analysis set, participants with objective response - inclusive of all randomized participants with an objective response (RECIST 1.1).|||Months||Inter-Quartile Range|Median
2583184|NCT02369874|Secondary|Objective Response Rate (ORR)|The percentage of participants who experienced an objective response (complete response [CR] or partial response [PR]), based on investigator assessments according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). A CR was defined as the disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm. A PR was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters.|Assessed at randomization and every 8 weeks thereafter|Full analysis set - inclusive of all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2583185|NCT02369874|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of randomization until the date of objective disease progression or death based on investigator assessments, according to response evaluation criteria in solid tumors 1.1 (RECIST1.1). Objective disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|September 2015 to September 2018 (36 months)|Full analysis set - inclusive of all randomized participants.|||Months||95% Confidence Interval|Median
2583186|NCT02369874|Secondary|Overall Survival (OS) in PD-L1 Positive Participants|OS is defined as the time from the date of randomization until death due to any cause. PD-L1 positive was defined as ≥25% of tumor cells with membrane staining for PD-L1 at any intensity.|September 2015 to September 2018 (36 months)|PD-L1-positive analysis set - inclusive of all randomized participants whose PD-L1 status is PD-L1-positive as defined by the Ventana PD-L1 SP263 IHC assay.|||Months||95% Confidence Interval|Median
2583187|NCT02369874|Secondary|Overall Survival (OS) in PD-L1 Negative Participants|OS is defined as the time from the date of randomization until death due to any cause. PD-L1 negative was defined as <25% of tumor cells with membrane staining for PD-L1 at any intensity.|September 2015 to September 2018 (36 months)|PD-L1-negative analysis set - inclusive of all randomized participants whose PD-L1 status is PD-L1-negative as defined by the Ventana PD-L1 SP263 IHC assay.|||Months||95% Confidence Interval|Median
2605714|NCT02107014|Primary|Change in FGF-β From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2583189|NCT02369848|Secondary|Clinical Success|"Change in Rutherford Clinical Category from Baseline to 30 days~There are seven stages to condsider:~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene"|30 days||||change in Rutherford score from baseline||95% Confidence Interval|Mean
2583190|NCT02369848|Secondary|Clinical Success|"Change in Rutherford Clinical Category from Baseline to12 months.~There are seven stages to condsider:~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene"|12 months||||change in Rutherford score from baseline||95% Confidence Interval|Mean
2583191|NCT02369848|Secondary|Clinical Success|"Change in Rutherford Clinical Category at from Baseline to 6 months.~There are seven stages to consider:~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene"|6 months||||change in Rutherford score from baseline||95% Confidence Interval|Mean
2583192|NCT02369848|Secondary|Clinical Success - Improvement of Ankle-Brachial (ABI) of the Target Limb.|The ankle-brachial pressure index or ankle-brachial index is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. It has been shown to be a specific and sensitive metric for the diagnosis of Peripheral Arterial Disease (PAD).|12 months||||Percent change in ABI from baseline||95% Confidence Interval|Mean
2583193|NCT02369848|Secondary|Clinical Success - Improvement of Ankle-Brachial Index (ABI) of the Target Limb.|The ankle-brachial pressure index or ankle-brachial index is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. It has been shown to be a specific and sensitive metric for the diagnosis of Peripheral Arterial Disease (PAD).|6 months||||Percent change in ABI from baseline||95% Confidence Interval|Mean
2583194|NCT02369848|Secondary|Secondary Patency Measured by Number of Participants With Target Lesion Patency (Without Adjunctive PTA) by Duplex Ultrasound Defined as Freedom From ≥50% Restenosis.||12 months||||Participants|||Count of Participants
2583195|NCT02369848|Secondary|Secondary Patency Measured by Number of Participants With Target Lesion Patency by Duplex Ultrasound Defined as Freedom From ≥50% Restenosis.||6 months||||Participants|||Count of Participants
2583196|NCT02369848|Secondary|Secondary Endpoint of Acute Procedural Success Achieved in Number of Participants|"The ability of the Shockwave Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive Percutaneous Transluminal Angioplasty (PTA) therapy) as assessed by quantitative angiography via core lab evaluation.~The ability of the Shockwave Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (without adjunctive PTA therapy) as assessed by quantitative angiography via core lab evaluation."|Day of Procedure|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted.|||Participants|||Count of Participants
2583197|NCT02369848|Secondary|Safety Measured by Number of Participants With Freedom From Major Adverse Events (MAEs)||12 months||||Participants|||Count of Participants
2583198|NCT02369848|Primary|Safety Endpoint Defined as Composite of New-onset Major Adverse Events (MAEs)|"Need for emergency surgical revascularization of target limb. Unplanned target limb amputation (above the ankle). Symptomatic thrombus or distal emboli, defined as clinical signs or symptoms of thrombus or distal emboli detected in the treated limb in the area of the treated lesion or distal to the treated lesion after the index procedure and results in extended hospitalization or noted angiographically, and requiring mechanical or pharmacologic means to improve flow and results in extended hospitalization.~Perforations and dissections of grade D or greater that require an intervention to resolve, including bail-out stenting."|Within 30 days following procedure||||Participants|||Count of Participants
2583199|NCT02369848|Primary|Effectiveness Endpoint Defined as Number of Participants withTarget Lesion Patency by Duplex Ultrasound Defined as Freedom From ≥50% Restenosis||12 months post-procedure|Data reflects number for participants who have an evaluable (diagnostic) scheduled or unscheduled duplex ultrasound based on reporting windows and slotting rules in the Statistical Plan. Thirty out of 43 participants achieved target lesion patency.|||Participants|||Count of Participants
2583200|NCT02369835|Secondary|Pain Associated With Radiation Dermatitis|"Quality of life was assessed as pain associated with radiation dermatitis. Assessments were baseline and through treatment follow-up 3 to 12 weeks after completion of radiation treatment. The assessment was to be conducted with a Modified Brief Pain Inventory (MBPI), a 13-question survey with responses ranging from 0 to 10, and an overall score of 0 to 130. A higher score indicates more pain and less quality of life. The outcome was to be reported by treatment group as the mean score with standard deviation.~Additional information describing this outcome is not available."|3 to 12 weeks after completion of radiation treatment|Data for pain associated with radiation dermatitis was not provided by the prior investigator to the current Responsible Party. On this basis, data is not available, and will never be available.||||||
2583212|NCT02369796|Primary|Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Once Weekly Dosing Groups|Area under the PD free ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.|Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.|||percent change||Standard Deviation|Mean
2583464|NCT02367352|Primary|Dose Expansion Phase: AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Alisertib||Day 1 and Day 3 predose and at multiple time points (up to 12 hours) post-dose|The dose expansion phase was cancelled by the sponsor.||||||
2583201|NCT02369835|Secondary|Time to Grade E Radiation Dermatitis|"Participants were assessed for radiation dermatitis on the arms according to the Stanford Radiation Dermatitis Scoring System (SRDSS), at baseline and through their treatment course. The time that SRDSS Grade E radiation dermatitis developed was noted. The outcome is reported by treatment group as the mean time to development of SRDSS Grade E radiation dermatitis, with standard deviation.~SRDSS, by grade:~A. No skin change~B. Faint, barely detectable erythema~C. Follicular rash, hyperpigmentation, evolving erythema~D. Dry desquamation, brisk erythema~E. Moist desquamation~F. Bleeding, ulceration, and/or infection~SRDSS Grade E is roughly equivalent to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Grade 3 radiation dermatitis, Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion.~Additional information describing this outcome is not available."|up to 12 weeks (estimated)|Data for time to Grade E radiation dermatitis was not provided by the prior investigator to the current Responsible Party. On this basis, data is not available, and will never be available.||||||
2583202|NCT02369835|Primary|Radiation Dermatitis|"Participants were assessed for radiation dermatitis on the arms according to the Stanford Radiation Dermatitis Scoring System (SRDSS), at baseline and through their treatment course. The outcome is reported by treatment group as the number and proportion of participants that experience SRDSS Grade E or greater radiation dermatitis through 10 weeks after completion of radiation treatment, a number without dispersion.~SRDSS, by grade:~A. No skin change~B. Faint, barely detectable erythema~C. Follicular rash, hyperpigmentation, evolving erythema~D. Dry desquamation, brisk erythema~E. Moist desquamation~F. Bleeding, ulceration, and/or infection~SRDSS Grade E is roughly equivalent to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 Grade 3 radiation dermatitis, Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion"|From first radiation treatment up to 10 weeks after completion of radiation treatment. Because much of the study data was not provided by the prior investigator to the current Responsible Party, it is not possible to be more precise than stated.|Not all participants completed radiation treatment, and are not included in the outcome.|||Participants|||Count of Participants
2583203|NCT02369796|Secondary|Mean Terminal Phase Elimination Half-life (T1/2) for TAK-448F|Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose|Pharmacokinetic (PK) set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F. Here, 'n' is the participants who were analyzed at specific time point.|||hr||Standard Deviation|Mean
2583204|NCT02369796|Secondary|AUC(0-tlqc): Mean Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-448F|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose|PK set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F.|||pg*hr/mL||Standard Deviation|Mean
2583205|NCT02369796|Secondary|AUC(0-∞): Mean Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-448F|AUC(0-∞) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose|PK set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F. Here, 'n' is the participants who were analyzed at specific time point.|||pg*hr/mL||Standard Deviation|Mean
2583206|NCT02369796|Secondary|Cmax: Mean Maximum Observed Plasma Concentration for TAK-448 Free Base Form (TAK-448F)|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 and Day 22 pre-dose and at multiple time points (up to 8 hours) post-dose|Pharmacokinetic (PK) set included all participants who received at least one dose of study drug and had at least 1 measurable concentration of TAK-448F.|||pg/mL||Standard Deviation|Mean
2583207|NCT02369796|Primary|Trough Serum Concentration (Ctrough) of Free Serum Testosterone for Twice Weekly Dosing Groups|Trough serum concentration of free ST, defined as lowest baseline concentration compared to pre-dose of the last dose.|Day 25 pre-dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.|||nmol/L||Standard Deviation|Mean
2583208|NCT02369796|Primary|Trough Serum Concentration (Ctrough) of Free Serum Testosterone for Once Weekly Dosing Groups|Trough serum concentration of free ST, defined as lowest baseline concentration compared to pre-dose of the last dose.|Day 22 pre-dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure. Number of participants analyzed is number of participants evaluated for this outcome measure.|||nmol/L||Standard Deviation|Mean
2583209|NCT02369796|Primary|Trough Serum Concentration (Ctrough) of Total Serum Testosterone for Twice Weekly Dosing Group|Trough serum concentration of total ST, defined as lowest baseline concentration compared to pre-dose of the last dose.|Day 25 pre-dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.|||nmol/L||Standard Deviation|Mean
2583210|NCT02369796|Primary|Trough Serum Concentration (Ctrough) of Total Serum Testosterone for Once Weekly Dosing Groups|Trough serum concentration of total ST, defined as lowest baseline concentration compared to pre-dose of the last dose.|Day 22 pre-dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.|||nmol/L||Standard Deviation|Mean
2583211|NCT02369796|Primary|Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Free Serum Testosterone for Twice Weekly Dosing Groups|Area under the PD free ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.|Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.|||percent change||Standard Deviation|Mean
2583230|NCT02369484|Secondary|Progression-free Survival|Progression-free survival (PFS) is defined as the time from date of enrollment until documented progression or death, if progression is not documented. Censoring will occur at the last tumor assessment only if patients is lost to follow-up|Time assessed from the date of enrolment until documented progression or death (max 36 months)|All patients enrolled up to trial termination|||weeks||95% Confidence Interval|Median
2583213|NCT02369796|Primary|Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Twice Weekly Dosing Groups|Area under the PD total ST concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.|Baseline and Day 25 pre-dose and multiple time points (up to 72 hours) post dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.|||percent change||Standard Deviation|Mean
2583214|NCT02369796|Primary|Percent Change From Baseline in Mean Area Under the Effect Curve From Time 0 to 72 Hours (AUEC72) of Total Serum Testosterone for Once Weekly Dosing Groups|Area under the pharmacodynamic (PD) total serum testosterone (ST) concentration-time curve from the time 0 to 72 hours, calculated using the linear trapezoidal rule for baseline profile and those obtained after first and last dose.|Baseline and Day 22 pre-dose and multiple time points (up to 72 hours) post dose|PD set included all participants who received at least one dose of study drug and had at least 1 valid PD measure.|||percent change||Standard Deviation|Mean
2583215|NCT02369744|Secondary|Adverse Hemodynamic Reaction|Both tamsulosin and silodosin carry the possibility of causing orthostatic hypotension, which can manifest as unsteadiness, syncope, headache, and/or dizziness, especially when changing position from sitting/laying to standing. Subjects will be asked to assess themselves for these symptoms continuously from the initial visit, with serious reactions resulting in cessation of study medication. For reactions which are not serious, the information will be collected at the one-week follow-up call as well as the two-week follow-up visit.|at 2 weeks|Data is not available||||||
2583216|NCT02369744|Secondary|Outpatient Treatment Failure|"Subjects will be given instructions at the initial visit to return to the emergency department immediately for signs and symptoms of infection or MET failure (fever, worsening pain, vomiting, lethargy, unsteadiness, syncope or inability to tolerate oral pain medications). These subjects will be considered to have failed outpatient treatment and will be removed from the study.~Subjects who do not experience these issues but who still report having symptoms at the two-week follow-up visit will also be considered to have failed outpatient treatment."|at 2 weeks|Data is not available||||||
2583217|NCT02369744|Secondary|Use of Pain Medication|The subject will be given a standardized pain medication prescription at their initial visit, and will be asked to keep track of how much pain medication they used each day, as well as to bring their pill bottle with them to the two-week follow-up appointment for a pill count. This information will be collected at the two-week follow-up appointment.|at 2 weeks|Data is not available||||||
2583218|NCT02369744|Primary|Time to Stone Passage|The primary outcome measure will be the time it takes for the stone to pass. Stone passage will be defined as the subject self-reporting passage of a stone that is consistent with their imaging, or resolution of their pain to suggest unseen passage of their stone. This outcome will be measured from the initial emergency department visit, and gathered at the one-week follow-up call as well as the two-week follow-up visit.|at 2 weeks|Data is not available||||||
2583219|NCT02369510|Secondary|Incidence of Pruritus|data not collected|up to 3 hours|||||||
2583220|NCT02369510|Secondary|Incidence of Nausea and Vomiting||up to 3 hours||||Participants|||Count of Participants
2583221|NCT02369510|Secondary|Patient Satisfaction|"Patient satisfaction score was elicited upon arrival to the recovery room on a 1-5 Likert scale. Number of participants selecting the highest score of 5 or completely satisfied."|up to 3 hours||||percentage of participants|||Number
2583222|NCT02369510|Secondary|Adequacy of Anesthesia|As measured by pinprick sensation and/or patient discomfort as measured by verbal pain score on a scale of 0=no pain to 10=worst imaginable pain, obtained within 3 hours of receiving anesthesia.|up to 3 hrs||||units on a scale||Inter-Quartile Range|Median
2583223|NCT02369510|Secondary|Number of Participants With Hypotension|Incidence of hypotension as measured by participants needing vasopressor agents|at 2 minutes and at 25 minutes||||Participants|||Count of Participants
2583224|NCT02369510|Secondary|Block Onset|Time to a onset of T4 level of anesthesia or the highest level achieved in 15min|up to 15 min||||minutes||Inter-Quartile Range|Median
2583225|NCT02369510|Secondary|Motor Recovery|Time to Bromage 3 motor recovery|up to 4 hours||||minutes||95% Confidence Interval|Median
2583226|NCT02369510|Primary|Sensory Recovery|Time to T10 sensory recovery as measured by pinprick sensation|up to 3 hours||||minutes||95% Confidence Interval|Median
2583227|NCT02369484|Secondary|Toxicities of Treatment|Adverse events classified according to NCI CTCAE version 4.|Assessed from the date of informed consent until 90 days after the final dose of afatinib (max 18 months).|All patients enrolled in the trial up to trial termination|||Participants|||Count of Participants
2583228|NCT02369484|Secondary|Overall Survival|Overall survival (OS) is defined as the time from the date of enrollment until death from any cause. Censoring will occur at the last follow-up.|Time assessed from the date of enrolment until death (max 36 months)|All patients enrolled in the trial up to trial termination|||weeks||95% Confidence Interval|Median
2583229|NCT02369484|Secondary|Objective Response|"Objective response is defined as best overall response (CR or PR) across all assessment time-points during the period from enrollment to termination of trial treatment. Objective response to afatinib treatment will be determined using RECIST 1.1 criteria:~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.~Progression (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on the trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions denotes disease progression.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on the trial."|Assessed across all time-points during the period from enrolment to termination of trial treatment (max. 36 months)|"All patients enrolled in the trial up to trial termination. From the total of 13 patients, one patient had only one tumor assessment and was classified as Non-Evaluable, since she cannot be accounted for the Objective Response rate."|||Participants|||Count of Participants
2583274|NCT02369172|Primary|Area Under the Concentration-time Curve Extrapolated to Infinite Time (AUC0-∞) of Bupropion||prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2583231|NCT02369484|Primary|Disease Control (Defined as Complete or Partial Response, or Disease Stabilisation Lasting at Least 12 Weeks)|"Disease control (DC) is defined as complete or partial response, or disease stabilisation lasting at least 12 weeks.~Disease control will be determined using RECIST 1.1 criteria:~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.~Progression (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on the trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions denotes disease progression.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on the trial."|at interim (after the first 9 pts have been followed for 12 weeks) & final analysis (approx. 40 months after inclusion of first pt)|The statistical design of the trial, included an interim efficacy analysis to be performed as soon as the 12-week status of the first 9 patients was available. So, the interim analysis was performed but up to then 13 patients have been enrolled.|||Participants|||Count of Participants
2583232|NCT02369341|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (approximately 21 days for each subject)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
2583233|NCT02369341|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 21-day (Days 0-20) post-vaccination period.|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
2583234|NCT02369341|Secondary|Duration of Solicited General Symptoms|Duration was defined as number of days with any grade of general symptoms.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||days||Full Range|Median
2583235|NCT02369341|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).|MAEs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAE was defined as at least one MAE experienced. Grade 3 was defined as MAEs that prevented normal activities and related was defined as MAEs assessed by the investigator to be causally related to the study vaccination.|During the entire study period (approximately 21 days for each subject).|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||subjects|||Number
2583236|NCT02369341|Secondary|Duration of Solicited Local Symptoms|Duration was defined as number of days with any grade of local symptoms.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||days||Full Range|Median
2583237|NCT02369341|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were Arthralgia, Fatigue, Gastrointestinal symptoms, Headache, Myalgia, Shivering, Sweating and Temperature (Oral). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
2583238|NCT02369341|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
2583239|NCT02369341|Secondary|Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.|SPP was defined as the number of vaccinated subjects with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2583240|NCT02369341|Secondary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination HI titer less than (<) 1:10 and a post-vaccination HI titer ≥1:40 or pre-vaccination HI titer ≥1:10 and at least a 4-fold increase in post-vaccination HI titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2583241|NCT02369341|Secondary|MGI for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.|MGI also known as the seroconversion factor [SCF] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Mean
2583242|NCT02369341|Secondary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2583243|NCT02369341|Secondary|Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cutoff value of 1:10. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2583244|NCT02369341|Secondary|Humoral Immune Response for Each Vaccine Strain in Terms of HI Antibodies.|Antibody titers were expressed as GMTs. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2583245|NCT02369341|Primary|Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains.|MGI also known as the seroconversion factor [SCF] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
2583246|NCT02369341|Primary|Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Above the Cut-off Value.|"SPP was defined as the number of vaccinated subjects with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.~The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria)."|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2583247|NCT02369341|Primary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination HI titer less than (<) 1:10 and a post-vaccination HI titer ≥1:40 or pre-vaccination HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination HI titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 21.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2583248|NCT02369341|Primary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2583249|NCT02369341|Primary|Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Vaccine Strains.|A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cutoff value of 1:10. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2595681|NCT02219282|Secondary|Ease of Placement Laryngeal Mask|Ease (according to Likert scale 1-4 point from easy to diffucult).|During Laryngeal mask placement||||Participants|||Count of Participants
2583250|NCT02369341|Primary|Humoral Immune Response for Each Vaccine Strain in Terms of Haemagglutination Inhibition (HI) Antibody Titers.|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Switzerland/9715293/2013 (H3N2), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Days 0 and 21.|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2583251|NCT02369211|Secondary|Opioid Use|A measure of the amount of opioid study patients used postoperatively while recovering from surgery at the hospital|0-24 hours|Patients who underwent surgery and stayed in the hospital as inpatients and received pain management.|||morphine milligram equivalents||Inter-Quartile Range|Median
2583252|NCT02369211|Secondary|Pain Score|"Pain scores were collected using the Visual Analog Scale. The scale range is 0 (no pain) to 10 (most pain).~Mean pain score over first 24 hours postoperatively was collected."|0-24 hours after surgery|Patients who were assessed for levels of pain following surgery, including both treatment and placebo arms.|||score on a scale||Inter-Quartile Range|Mean
2583253|NCT02369211|Primary|Hospital Length of Stay|This outcome measure calculates the number of days the patient stayed in the hospital before being discharged home.|1-3 days|Patients who were admitted to the hospital (as inpatients) following surgery and post-anesthesia care unit stay.|||Days||95% Confidence Interval|Median
2583254|NCT02369211|Primary|Post Anesthesia Care Unit Length of Stay|The amount of time patients stayed in the post-anesthesia care unit following anesthesia, before going to the inpatient ward.|approximately 30-240 min|Patients who had surgery and were then transferred to the post-anesthesia care unit for recovery.|||minutes||Standard Deviation|Mean
2583255|NCT02369172|Other Pre-specified|Apparent Total Body Clearance (CL/F) of Bupropion||prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29||||L/h||Standard Deviation|Mean
2583256|NCT02369172|Other Pre-specified|Apparent Volume of Distribution (Vd/F) of Bupropion||prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29||||L||Standard Deviation|Mean
2583257|NCT02369172|Other Pre-specified|Half-life (t1/2) of Bupropion||prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29||||h||Geometric Coefficient of Variation|Geometric Mean
2583258|NCT02369172|Other Pre-specified|Area Under the Curve Over up to Last No-zero Value (AUC0-tn) of Bupropion||prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2583259|NCT02369172|Other Pre-specified|Time of Peak Concentration (Tmax) of Bupropion||prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29||||h||Full Range|Median
2583260|NCT02369172|Other Pre-specified|Apparent Total Body Clearance (CL/F) of ASP2151||prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15||||L/h||Standard Deviation|Mean
2583261|NCT02369172|Other Pre-specified|Apparent Volume of Distribution (Vd/F) of ASP2151||prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15||||L||Standard Deviation|Mean
2583262|NCT02369172|Other Pre-specified|Half-life (t1/2) of ASP2151||prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15||||h||Geometric Coefficient of Variation|Geometric Mean
2583263|NCT02369172|Other Pre-specified|Area Under the Concentration-time Curve Extrapolated to Infinite Time (AUC0-∞) of ASP2151||prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2583264|NCT02369172|Other Pre-specified|Area Under the Concentration-time Curve Over the Dosing Interval (AUC0-tau) of ASP2151||prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2583265|NCT02369172|Other Pre-specified|Time of Peak Concentration (Tmax) of ASP2151||prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15||||h||Full Range|Median
2583266|NCT02369172|Other Pre-specified|Peak Plasma Concentration (Cmax) of ASP2151||prior to initial dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2583267|NCT02369172|Other Pre-specified|Trough Plasma Concentration (Ctrough) of ASP2151||Days 6-14 and at pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 h after dosing on Day 15||||ng/mL||Standard Deviation|Mean
2583268|NCT02369172|Other Pre-specified|Half-life (t1/2) of Hydroxybupropion||prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29||||h||Geometric Coefficient of Variation|Geometric Mean
2583269|NCT02369172|Other Pre-specified|Area Under the Concentration-time Curve Extrapolated to Infinite Time (AUC0-∞) of Hydroxybupropion||prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2583270|NCT02369172|Other Pre-specified|Area Under Concentration-Time Curve up to Last Non-zero Value (AUC0-tn) of Hydroxybupropion||prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2583271|NCT02369172|Other Pre-specified|Time of Peak Concentration (Tmax) of Hydroxybupropion||prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29||||h||Full Range|Median
2583272|NCT02369172|Other Pre-specified|Peak Plasma Concentration (Cmax) of Hydroxybupropion||prior to initial dose of Day 1 and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, 72 and 96 h after dosing on Day 1, Days 15, 22 and 29||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2583273|NCT02369172|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Refer to the result of adverse event.|Up to 32 days after the last dose||||participants|||Number
2583276|NCT02369068|Secondary|Pain Assessed by Change in Overall Pain and Other Related Scores Using the Global Response Assessment (GRA) Questionnaire.|The GRA questionnaire asks subjects to rate symptoms and functioning since having the research procedure, Trigger Point Injections (TPI). Scores are on a Likert scale, ranging from 1 (Markedly Worse) to 7 (Markedly Improved).|Baseline and Six Months||||Participants|||Count of Participants
2583277|NCT02369068|Secondary|Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire.|The Pain Interference score was constructed by averaging the individual interference question scores from the brief pain inventory questionnaire (adding together scores for questions 9A-9G and dividing by 7). The questions assess how, during the past 24 hours, pain has interfered with general anxiety (9A), mood (9B), walking ability (9C), normal work (9D), relations with other people (9E), sleep (9F), and enjoyment of life (9G). Each question is scored on a scale from 0 (does not interfere) to 10 (completely interferes). Thus, a lower value represents a better outcome. The difference between pain interference at 6 months and the pain interference at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 6 months and negative numbers indicates that the severity of the pain decreased.|Baseline and Six months||||units on a scale||Full Range|Median
2583278|NCT02369068|Secondary|Pain Severity Assessed by Change in Overall Pain and Other Related Scores Using Questions 3, 4, 5, and 6 in the Brief Pain Inventory (BPI) Questionnaire.|Pain severity was constructed by averaging questions 3,4,5 and 6 of the brief pain inventory questionnaire (adding scores together and dividing by 4). Each question is on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). Thus, lower numbers represent a better outcome. The difference between pain severity at 6 months and the pain severity at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 6 months and negative numbers indicates that the severity of the pain decreased.|Baseline and Six Months||||units on a scale||Full Range|Median
2583279|NCT02369068|Secondary|Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire.|The pain visual analog scale (VAS) is a tool used by the patient to describe their pain intensity. Utilizing the VAS, the patient describes their pain at baseline, before receiving trigger point injections. The VAS ranges from 0 (no pain) to 10 (worst possible pain). Thus, a lower value represents a better outcome.|Baseline and Six Months||||units on a scale||Full Range|Median
2583280|NCT02369068|Secondary|Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.|The GRA questionnaire asks subjects to rate symptoms and functioning since having the research procedure, Trigger Point Injections (TPI). Question 2 asks the subject to rate their pain symptoms since having TPI. Scores are on a Likert scale, ranging from 1 (Markedly Worse) to 7 (Markedly Improved).|Baseline and Three Months|At 3 months, 9 subjects in the Onabotulinumtoxin A group completed the study and 8 completed in the Kenalog group. One subject in the Onabotulinumtoxin A did not have information for pain symptoms using question 2 in the global response assessment (missing data for this outcome, analysis conducted on 8 patients).|||Participants|||Count of Participants
2583281|NCT02369068|Secondary|Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire.|The Pain Interference score was constructed by averaging the individual interference question scores from the brief pain inventory questionnaire (adding scores together for questions 9A-9G and dividing by 7). The questions assess how, during the past 24 hours, pain has interfered with general anxiety (9A), mood (9B), walking ability (9C), normal work (9D), relations with other people (9E), sleep (9F), and enjoyment of life (9G). Each question is scored on a scale from 0 (does not interfere) to 10 (completely interferes). Thus, a lower value represents a better outcome. The difference between pain interference at 3 months and the pain interference at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 3 months and negative numbers indicates that the severity of the pain decreased.|Baseline and Three months|At 3 months, 9 subjects in the Onabotulinumtoxin A group completed the study and 8 completed in the Kenalog group. One subject in the Onabotulinumtoxin A did not have information for pain interference (missing data for this outcome, analysis conducted on 8 patients).|||units on a scale||Full Range|Median
2583282|NCT02369068|Secondary|Pain Severity Assessed by Change in Overall Pain and Other Related Scores Using Questions 3, 4, 5, and 6 in the Brief Pain Inventory (BPI) Questionnaire.|Pain severity was constructed by averaging questions 3,4,5 and 6 of the brief pain inventory questionnaire (adding scores and dividing by 4). Each question is on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). Thus, lower numbers represent a better outcome. The difference between pain severity at 3 months and the pain severity at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 3 months and negative numbers indicates that the severity of the pain decreased.|Baseline and Three Months|At 3 months, 9 subjects in the Onabotulinumtoxin A group completed the study and 8 completed in the Kenalog group. One subject in the Onabotulinumtoxin A did not have information for pain severity (missing data for this outcome, analysis conducted on 8 patients).|||units on a scale||Full Range|Median
2583283|NCT02369068|Secondary|Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS) Questionnaire.|The visual analog scale asks subjects to rate their level of pain on a scale from 0-10, with 0 being 'No pain' and 10 being 'Worst pain imaginable', hence lower scores are better. The baseline and follow-up visual analog scale for pain was obtained at every visit regardless if the patient received Trigger Point Injections. The difference between visual analog scale at 3 months and the visual analog scale at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 3 months and negative numbers indicates that the severity of the pain decreased.|Baseline and Three Months|At 3 months, 9 subjects in the Onabotulinumtoxin A group completed the study and 8 completed in the Kenalog group. One subject in the Onabotulinumtoxin A did not have the pain assessed using the visual analog scale (missing data for this outcome, analysis conducted on 8 patients).|||units on a scale||Full Range|Median
2583284|NCT02369068|Primary|Pain Assessed by Change in Overall Pain Symptom Using Question 2 of the Global Response Assessment (GRA) Questionnaire.|The GRA questionnaire asks subjects to rate symptoms and functioning since having the research procedure, Trigger Point Injections (TPI). Question 2 asks the subject to rate their pain symptoms since having TPI. Scores are on a Likert scale, ranging from 1 (Markedly Worse) to 7 (Markedly Improved).|Baseline and One Month||||Participants|||Count of Participants
2583285|NCT02369068|Primary|Pain Interference Assessed by Change in Overall Pain and Other Related Scores Using Questions 9A Through 9G in the Brief Pain Inventory (BPI) Questionnaire.|The Pain Interference score was constructed by averaging the individual interference question scores from the brief pain inventory questionnaire (adding scores from questions 9A-9G and dividing by 7). The questions assess how, during the past 24 hours, pain has interfered with general anxiety (9A), mood (9B), walking ability (9C), normal work (9D), relations with other people (9E), sleep (9F), and enjoyment of life (9G). Each question is scored on a scale from 0 (does not interfere) to 10 (completely interferes). Thus, a lower value represents a better outcome. The difference between pain interference at 1 month and the pain interference at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 1 month and negative numbers indicates that the severity of the pain decreased.|Baseline and One Month||||units on a scale||Full Range|Median
2583286|NCT02369068|Primary|Pain Severity Assessed by Change in Overall Pain and Other Related Scores Using Questions 3, 4, 5, and 6 in the Brief Pain Inventory (BPI) Questionnaire.|Pain severity was constructed by averaging questions 3,4,5 and 6 of the brief pain inventory questionnaire (adding scores together and dividing by 4). Each question is on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). Thus, lower numbers represent a better outcome. The difference between pain severity at 1 month and the pain severity at baseline was calculated. Positive numbers indicate the pain severity increased from baseline to 1 month and negative numbers indicates that the severity of the pain decreased.|Baseline and One Month||||units on a scale||Full Range|Median
2583287|NCT02369068|Primary|Pain Assessed by Change in Overall Pain Score Using the Visual Analog Scale (VAS).|The visual analog scale asks subjects to rate their level of pain on a scale from 0-10, with 0 being 'No pain' and 10 being 'Worst pain imaginable', hence lower scores are better. The baseline and follow-up visual analog scale for pain was obtained at every visit regardless if the patient received Trigger Point Injections. The difference between visual analog scale at 1 month and the visual analog scale at baseline was calculated. Positive numbers indicate the pain increased from baseline to 1 month and negative numbers indicates that pain decreased.|Baseline and One Month||||units on a scale||Full Range|Median
2583288|NCT02368886|Other Pre-specified|Pharmacokinetics (PK) Parameters of Regorafenib Using Liquid Chromatography Mass Spectrometry|After quantitation, the average trough concentration, calculated from all available data, will be calculated. This average trough concentration will be correlated with toxicity and efficacy endpoints. Further descriptive characteristics of the pharmacokinetics will also be calculated, an example includes (but is not limited to) within-patient variability in the trough concentrations pharmacokinetic parameters will also be calculated, both overall and within courses, as a ratio of the maximum:minimum value.|Baseline, prior to treatment, days 7, 14, and 21 prior to treatment (course 1), and days 1 and 21 prior to treatment (course 2)|||||||
2583289|NCT02368886|Secondary|Changes in QOL (According to the Linear Analogue Self-Assessment [LASA] Questionnaire)|Changes in QOL (according to the LASA questionnaire as measured by the overall QOL question) from baseline will be compared between the treatment arms using the t-test or Wilcoxon rank sum test.|Baseline to up to 8 weeks||2020-06-30|06/2020||||
2583290|NCT02368886|Secondary|Changes in Quality of Life (QOL) (According to the HFS14 Questionnaire)|Patients will be descriptively compared between treatment arms and between HFS treatment strategies (pre-emptive vs. reactive) according to self-reported outcomes given on the HFS14 questionnaire. Results from the course 1 and 2 HSF14 questionnaires will also be summarized descriptively as they relate to the pre-emptive versus reactive palmar-plantar erythrodysesthesia syndrome (PPES) strategies, with comparisons made within and between arms using the t-test or Wilcoxon rank sum test as appropriate, as well as taking time-dependence into account.|Baseline to up to 8 weeks||2020-06-30|06/2020||||
2583291|NCT02368886|Secondary|Proportion of Patients Overall and Within Each Arm Experiencing Grade 3 or 4 Hand and Foot Syndrome (HFS) or Fatigue|Will be computed with 95% confidence intervals, and differences between regorafenib dosing strategies (pooled across HFS strategies) tested using a Fisher Exact test. The incidence of grade 3 or 4 HFS will also be descriptively compared between those receiving a pre-specified preemptive vs. reactive approach for hand and foot syndrome (pooled across dosing strategies), and tested using a Fisher Exact test.|Up to 2 years||2020-06-30|06/2020||||
2583292|NCT02368886|Secondary|Dose Intensity of Regorafenib Received by Patients in the First Two Cycles as Measured by the Percentage of Planned Dose Received|Dose intensity of regorafenib received by patients in the first two cycles as measured by the percentage (%) of planned dose received|Up to 8 weeks|The data for the pre-emptive & reactive treatment with clobatasol were pooled for the comparison of the two dosing strategies ((Arms A1 + A2) versus (Arms B1 + B2)).|||percentage of planned dose received||Standard Deviation|Median
2583293|NCT02368886|Secondary|Cumulative (Total) Dose of Regorafenib Received by Patients in the First Two Cycles|Will be summarized with descriptive statistics and compared between regorafenib arms (A vs. B).|Up to 8 weeks|The data for the pre-emptive & reactive treatment with clobatasol were pooled for the comparison of the two dosing strategies ((Arms A1 + A2) versus (Arms B1 + B2)). There are patients off-protocol treatment during cycle 1; therefore, we do not have cycle 2 dosing information for those patients who are off-protocol treatment during cycle 1.|||mg/day||Standard Deviation|Mean
2583294|NCT02368886|Secondary|Time to Progression (TTP)|TTP is defined as the time from randomization to disease progression, where PD is defined by RECIST 1.1 and will be estimated with Kaplan-Meier survival curves and differences between regorafenib arms (A vs. B) tested using log-rank tests, though these analyses are not powered for formal non-inferiority assessments.|Time from randomization to disease progression, where PD is defined by RECIST 1.1, assessed up to 2 years|The data for the pre-emptive and reactive treatment with clobatasol were pooled for the comparison of the two dosing strategies (regorafenib dose escalation group (Arms A1 + A2) versus regorafenib standard dose group (Arms B1 + B2)).|||months||95% Confidence Interval|Median
2583295|NCT02368886|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause, where progressed disease (PD) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and will be estimated with Kaplan-Meier survival curves and differences between regorafenib arms (A vs. B) tested using log-rank tests, though these analyses are not powered for formal non-inferiority assessments.|Time from randomization to the earlier of disease progression or death due to any cause, where progressed disease (PD) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, assessed up to 2 years||||months||95% Confidence Interval|Median
2583296|NCT02368886|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to death due to any cause and will be estimated with Kaplan-Meier survival curves and differences between regorafenib arms (A vs. B) tested using log-rank tests, though these analyses are not powered for formal non-inferiority assessments.|Time from randomization to death due to any cause, assessed up to 2 years|The data for the pre-emptive and reactive treatment with clobatasol were pooled for the comparison of the two dosing strategies (regorafenib dose escalation group (Arms A1 + A2) versus regorafenib standard dose group (Arms B1 + B2)).|||months||95% Confidence Interval|Median
2583297|NCT02368886|Primary|Proportion of Patients in Each Arm Who Complete 2 Cycles of Protocol Treatment and Initiate Cycle 3|Fisher exact test will be used to detect a difference course 3 between arms (starting low dose [pooled arm A1 and A2] versus [vs.] standard dose [pooled arm B1 and B2]). The proportion of patients who complete 2 courses of protocol treatment and initiate course 3 will be computed by arm with its 95% confidence interval using exact method.|At 8 weeks|The data for the pre-emptive and reactive treatment with clobatasol were pooled for the comparison of the two dosing strategies (regorafenib dose escalation group (Arms A1 + A2) versus regorafenib standard dose group (Arms B1 + B2)).|||proportion of patients||95% Confidence Interval|Number
2583298|NCT02368457|Secondary|Clinical Symptoms Evaluation, Measured Using the LENT-SOMA Scale|"Evaluation of symptoms improvement using the LENT-SOMA scale (Late Effect Normal Tissue Task Force / Subjective, Objective, Management, Analytic scale).~To examine the LENT/SOMA scale prospectively using interviews and questionnaires~Assessments were made from baseline to 1, 3, 6 and 9 months of starting treatments. The acceptability and feasibility of using the scales was examined using compliance in completion of the questionnaires.~Maximum score: 36 Minimum score: 0~Questionnaires have been completed for 24 patients after treatment. Higher values represents worse outcome.~Scale categories:~Subjective: pain, nutritional problems, difficulty in mouth openning. Objective: bone exposure, trismus, Management: analgesic treatment, oral treatment, nutrition. Analytic: radiological findings."|From baseline to 1,3, 6, 9 months of starting treatment||||units on a scale||Full Range|Mean
2583299|NCT02368457|Primary|Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG).|"Clinical healing assessment as measured with the classification of ORN stages, area of bone exposed (mm2) and radiological findings (OPG).~Intraoral bone exposure is measured in mm2."|From baseline to 1, 3, 6, and 9 months of starting treatment|mean of intraoral bone exposure (measured in mm2) from baseline to 1, 3, 6, 9, 12 and 18 months of starting treatment|||mm2||Full Range|Mean
2583300|NCT02368314|Secondary|Frequency of Other AE SAE||During the treatment period (14 days) and follow-up period (till 60-th day)|||||||
2583301|NCT02368314|Secondary|Frequency of Strokes, Myocardial Infarction, Unstable Angina and Cardiovascular Death||During the treatment period (14 days) and follow-up period (till 60-th day)|||||||
2583302|NCT02368314|Secondary|Frequency of Heparin Induced Thrombocytopenia||During the treatment period (14 days)|||||||
2583303|NCT02368314|Secondary|Frequency of All Bleedings||During the treatment period (14 days)|||||||
2583304|NCT02368314|Secondary|"Frequency of Other Small Bleedings"||During the treatment period (14 days)|||||||
2583305|NCT02368314|Secondary|Frequency of Clinically Significant Bleedings||During the treatment period (14 days)|||||||
2583306|NCT02368314|Secondary|"Frequency of Clinically Significant Small Bleedings"||During the treatment period (14 days)|||||||
2583307|NCT02368314|Secondary|"Frequency of Big Bleedings"||During the treatment period (14 days)|||||||
2583308|NCT02368314|Secondary|"Frequency of Big and Clinically Significant Small Bleedings"||During the treatment period (14 days)|||||||
2583309|NCT02368314|Secondary|Frequency of Venous Thromboembolism (PATE and/or DTV)||During the treatment period (14 days) and follow-up period (till 60-th day)|||||||
2583310|NCT02368314|Secondary|Frequency of Death From Other Causes||During the treatment period (14 days) and follow-up period (till 60-th day)|||||||
2583311|NCT02368314|Secondary|Frequency of Venous Thromboembolism Death||During the treatment period (14 days) and follow-up period (till 60-th day)|||||||
2583312|NCT02368314|Secondary|Frequency of Symptomatic Nonlethal PATE||During the treatment period (14 days) and follow-up period (till 60-th day)|||||||
2583313|NCT02368314|Secondary|Frequency of Distal DVT|Frequency of distal DVT (symptomatic or asymptomatic)|During the treatment period (14 days) and follow-up period (till 60-th day)|||||||
2583314|NCT02368314|Secondary|Frequency of Proximal DVT|Frequency of proximal DVT (symptomatic or asymptomatic)|During the treatment period (14 days) and follow-up period (till 60-th day)|||||||
2583315|NCT02368314|Secondary|Frequency of DTV|Frequency of DTV (proximal and/or distal; symptomatic or asymptomatic)|During the treatment period (14 days) and follow-up period (till 60-th day)|||||||
2583316|NCT02368314|Primary|Frequency of Venous Thromboembolism Death||During the treatment period (14 days)|Patient who finished the study as per protocol and had contrast venography results for efficacy evaluation.|||participants|||Number
2583317|NCT02368314|Primary|Frequency of Symptomatic Nonlethal Thromboembolia of the Pulmonary Artery (PATE)||During the treatment period (14 days)|Patient who finished the study as per protocol and had contrast venography results for efficacy evaluation.|||participants|||Number
2583318|NCT02368314|Primary|Frequency of DVT.|Frequency of deep vein thrombosis (DVT) (proximal and/or distal; symptomatic or asymptomatic).|During the treatment period (14 days)|Patient who finished the study as per protocol and had contrast venography results for efficacy evaluation.|||participants|||Number
2583319|NCT02368210|Other Pre-specified|Change in Percent Body Surface Area (BSA) With Active Psoriasis|The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject's palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area.|Baseline and Day 15|Analysis shown is based on the Intent-to-Treat (ITT) population and observed results.|||Change in percent BSA||Standard Deviation|Mean
2583320|NCT02368210|Other Pre-specified|Change From Baseline in Pruritus Score|Pruritus scale will be used to assess the subjective and multidimensional experience of the subject's pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus).|Baseline and Day 15|Analysis shown is based on the Intent-to-Treat (ITT) population and observed results.|||units on a scale||Standard Deviation|Mean
2583321|NCT02368210|Other Pre-specified|"Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)"|"Treatment success and clinical signs as defined in the secondary outcome measure. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 8|Analysis shown is based on the Intent-to-Treat (ITT) population and observed results.|||percentage of participants|||Number
2583322|NCT02368210|Other Pre-specified|"Percentage of Subjects With IGA Treatment Success"|"Treatment success and IGA as defined in the primary outcome measure. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 8|Analysis shown is based on the Intent-to-Treat (ITT) population and observed results.|||percentage of participants|||Number
2583323|NCT02368210|Secondary|"Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)"|"A static assessment of the overall or average degree of severity of each of three key characteristics present within all of the subject's psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 15|Analysis shown is based on the ITT population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.|||percentage of participants|||Number
2583324|NCT02368210|Primary|"Percentage of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA)"|"The IGA score is a static evaluation of the overall or average degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 15|Analysis shown is based on the ITT population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.|||percentage of participants|||Number
2583325|NCT02368093|Primary|Good European League Against Rheumatism (EULAR) Therapeutic Response Rate||6 months||||participants|||Number
2583326|NCT02367911|Other Pre-specified|Change in % Body Surface Area (BSA) With Active Psoriasis|The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject's palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area.|Day 8 and Day 15|||||||
2583327|NCT02367911|Other Pre-specified|Change From Baseline in Pruritus Score|Pruritus scale will be used to assess the subjective and multidimensional experience of the subject's pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus).|Day 15|||||||
2583328|NCT02367911|Other Pre-specified|"Proportion of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)"|"Treatment success and clinical signs as defined in the secondary outcome measure."|Day 8|||||||
2583329|NCT02367911|Other Pre-specified|"Proportion of Subjects With IGA Treatment Success"|"Treatment success and IGA as defined in the primary outcome measure."|Day 8|||||||
2583330|NCT02367911|Secondary|"Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)"|"A static assessment of the overall or average degree of severity of each of three key characteristics present within all of the subject's psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 15|Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Missing data was imputed as failure.|||percentage of participants|||Number
2583331|NCT02367911|Primary|"Percentage of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA)"|"The IGA score is a static evaluation of the overall or average degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe)."|Day 15|Analysis shown is based on the ITT population, defined as all enrolled participants who were randomized and dispensed the test article.|||percentage of participants|||Number
2583332|NCT02367885|Secondary|GMT of SRH Antibody Titer (Vero Antigen)|GMT of SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||titer||95% Confidence Interval|Geometric Mean
2583333|NCT02367885|Secondary|GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination|GMFI from baseline in SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||fold increase||95% Confidence Interval|Geometric Mean
2583465|NCT02367352|Primary|Dose Expansion Phase: Tmax: Time to Reach the Maximum Plasma Concentration of Alisertib||Day 1 and Day 3 predose and at multiple time points (up to 12 hours) post-dose|The dose expansion phase was cancelled by the sponsor.||||||
2583334|NCT02367885|Secondary|Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen)|Seroconversion rate was measured by SRH antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 50% increase from baseline (with a baseline SRH antibody titer of >4 mm^2), or achieving a SRH antibody titer of >=25 mm^2 (with baseline SRH antibody titer of <=4 mm^2) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||percentage of participants||95% Confidence Interval|Number
2583335|NCT02367885|Secondary|Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2|Seroprotection rate was measured by SRH antibody titer (Vero Antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with SRH antibody titer of >=25 mm^2. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||percentage of participants||95% Confidence Interval|Number
2583336|NCT02367885|Secondary|GMT of HI Antibody Titer (Vero Antigen)|GMT of HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||titer||95% Confidence Interval|Geometric Mean
2583337|NCT02367885|Secondary|GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination|GMFI from baseline in HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||fold increase||95% Confidence Interval|Geometric Mean
2583338|NCT02367885|Secondary|Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen)|Seroconversion rate was measured by HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||percentage of participants||95% Confidence Interval|Number
2583339|NCT02367885|Secondary|Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40|Seroprotection rate was measured by HI antibody titer (Vero antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||percentage of participants||95% Confidence Interval|Number
2583340|NCT02367885|Secondary|GMT of SRH Antibody Titer (Egg-Derived Antigen)|GMT of SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||titer||95% Confidence Interval|Geometric Mean
2583341|NCT02367885|Secondary|GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination|GMFI from baseline in SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6 -35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||fold increase||95% Confidence Interval|Geometric Mean
2583362|NCT02367872|Primary|Excretion Ratio of TAK-272F in Dialysate in Cohort 5R|Excretion ratio (% of dose) of TAK-272F in dialysis fluid was calculated for each participant.|Day 1: Pre-dose, up to 6 hours post-dose|The dialysate PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for dialysate PK.|||percentage of dose||Standard Deviation|Mean
2595982|NCT02216357|Secondary|Incidence and Severity of Treatment-emergent Adverse Events||Up to Study Day 7|Number of subject reporting at least one adverse event|||Participants|||Count of Participants
2583342|NCT02367885|Secondary|Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)|Seroconversion rate was measured by SRH antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroconversion rate was defined as the percentage of participants achieving a minimal 50% increase from baseline (with a baseline SRH antibody titer of >4 mm^2) or achieving a SRH antibody titer of >=25 mm^2 (with baseline SRH antibody titer of <=4 mm^2) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain). Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||percentage of participants||95% Confidence Interval|Number
2583343|NCT02367885|Secondary|Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2)|Seroprotection rate was measured by SRH antibody titer (egg- derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination for all groups. Seroprotection rate was defined as the percentage of participants with SRH antibody titer of >=25 mm^2. Analysis after Vaccination 2 is only applicable for 6-35 months old group and 3-12 years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time points.|||percentage of participants||95% Confidence Interval|Number
2583344|NCT02367885|Secondary|Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)|GMT of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after each vaccination. Analysis after Vaccination 2 is only applicable for 6-35 Months old group and 3-12 Years old group.|Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)|All participants included in FAS (all participants who received at least 1 dose of study vaccination) who had available data for specified strain at specified post-baseline time points.|||titer||95% Confidence Interval|Geometric Mean
2583345|NCT02367885|Secondary|GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after first vaccination for two age groups: 6-35 months and 3-12 years.|Day 22 (21 days after Vaccination 1)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.|||fold increase||95% Confidence Interval|Geometric Mean
2583346|NCT02367885|Secondary|Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|Seroconversion rate was measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after the first vaccination for two age groups: 6-35 months and 3-12 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 22 (21 days after Vaccination 1)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.|||percentage of participants||95% Confidence Interval|Number
2583347|NCT02367885|Secondary|Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >= 40: 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12- Years Old Group|Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after first vaccination for two age groups: 6-35 months and 3-12 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40.|Day 22 (21 days after Vaccination 1)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.|||percentage of participants||95% Confidence Interval|Number
2583348|NCT02367885|Primary|GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years.|Day 43 (21 days after Vaccination 2)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.|||fold increase||95% Confidence Interval|Geometric Mean
2583349|NCT02367885|Primary|Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Vaccination for 13-19 Years Old Group|GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years.|Day 22 (21 days after Vaccination)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.|||fold increase||95% Confidence Interval|Geometric Mean
2583350|NCT02367885|Primary|Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|Seroconversion rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with a baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 43 (21 days after Vaccination 2)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.|||percentage of participants||95% Confidence Interval|Number
2583351|NCT02367885|Primary|Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen): 21 Days After the Vaccination for 13-19 Years Old Group|Seroconversion rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of >=10), or achieving a HI antibody titer of >=40 (with a baseline HI antibody titer of <10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 22 (21 days after Vaccination)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.|||percentage of participants||95% Confidence Interval|Number
2583352|NCT02367885|Primary|Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group|Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40.|Day 43 (21 days after Vaccination 2)|All participants included in the FAS (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.|||percentage of participants||95% Confidence Interval|Number
2583353|NCT02367885|Primary|Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Vaccination for 13-19 Years Old Group|Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of >=40.|Day 22 (21 days after Vaccination)|All participants included in the full analysis set (FAS) (all participants who received at least 1 dose of study vaccination) who had data available for specified strain at specified post-baseline time point.|||percentage of participants||95% Confidence Interval|Number
2583354|NCT02367885|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. AEs included both SAE and non-SAE.|Up to 21 days after any vaccination|Safety analysis set included all participants who received at least 1 dose of study vaccination.|||participants|||Number
2583355|NCT02367885|Primary|Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group|Local reactions and systemic events were recorded using a diary. Number of participants with local reactions (Injection site pain, Injection site redness, Injection site swelling, Injection site induration, Injection site tenderness, Injection site ecchymosis) and systemic events (Pyrexia, malaise, chills, fatigue, headache, sweaty, myalgia, nausea, vomiting) were reported. Participants may be represented in more than 1 category.|Up to 21 days after any vaccination|Safety analysis set included all participants who received at least 1 dose of study vaccination.|||participants|||Number
2583356|NCT02367885|Primary|Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group|Local reactions and systemic events were recorded using a diary. Number of participants with local reactions (Injection site tenderness, Injection site ecchymosis, Irritability postvaccinal) and systemic events (Pyrexia, sweaty, vomiting, crying abnormal, inappetence, somnolence, sleeplessness) were reported. Participants may be represented in more than 1 category.|Up to 21 days after any vaccination|Safety analysis set included all participants who received at least 1 dose of study vaccination.|||participants|||Number
2583357|NCT02367872|Secondary|Number of Participants With TEAE Related to Laboratory Tests|"Number of participants with TEAE related to laboratory tests was reported in this outcome measure. The related event to report was only Alanine Aminotransferase Increased throughout this study."|Baseline up to Day 8 of each Cohort|The safety analysis set included all participants who were treated with at least 1 dose of study drug.|||participants|||Number
2583358|NCT02367872|Secondary|Number of Participants With TEAE Related to 12-lead Electrocardiograms (ECG)|Number of participants with TEAE related to ECG was reported in this outcome measure. There were no events to report as TEAE related to ECG throughout this study.|Baseline up to Day 8 of each Cohort|The safety analysis set included all participants who were treated with at least 1 dose of study drug.|||participants|||Number
2583359|NCT02367872|Secondary|Number of Participants With TEAE Related to Body Weight|Number of participants with TEAE related to body weight was reported in this outcome measure. There were no events to report as TEAE related to body weight throughout this study.|Baseline up to Day 8 of each Cohort|The safety analysis set included all participants who were treated with at least 1 dose of study drug.|||participants|||Number
2583360|NCT02367872|Secondary|Number of Participants With TEAE Related to Vital Signs|"Number of participants with TEAE related to vital signs was reported in this outcome measure. The related event to report was only Blood Pressure Decreased throughout this study."|Baseline up to Day 8 of each Cohort|The safety analysis set included all participants who were treated with at least 1 dose of study drug.|||participants|||Number
2583361|NCT02367872|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)||Baseline up to Day 8 of each Cohort|The safety analysis set included all participants who were treated with at least 1 dose of study drug.|||participants|||Number
2583395|NCT02367794|Secondary|Percentage of Participants With Objective Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population||Up to approximately 30 months after first participant enrolled||2020-10-31|10/2020||||
2583396|NCT02367794|Secondary|OS in the TC1/2/3 or IC1/2/3 Population||Up to approximately 39 months after first participant enrolled||2020-10-31|10/2020||||
2583363|NCT02367872|Primary|Plasma Protein Binding Rate of TAK-272F in Cohorts 1R, 2R, 3R, 4R, 5R, 1H, 2H and 3H|Plasma protein binding rate was the percentage of unbound fraction of TAK-272F in plasma protein.|Baseline|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||% of unbound fraction of TAK-272F||Standard Deviation|Mean
2583364|NCT02367872|Primary|Cumulative Urinary Excretion Ratio of TAK-272F and Its Metabolite M-I From 0 to 72 Hours Post-dose in Cohorts 1R, 2R, 3R, 4R, 1H, 2H and 3H|Urinary excretion ratio (percentage [%] of dose) of TAK-272 and its metabolite M-I in urine was calculated for each participant.|Day 1: Pre-dose and at multiple time points (4, 8, 12, 24, 36, 48, 72 hours post dose; up to 72 hours) post-dose|The urine PK analysis population where urinary excretion data on Day 1 was available. The urine PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for urine PK.|||percentage of dose||Standard Deviation|Mean
2583365|NCT02367872|Primary|CLu/F: Apparent Clearance for Unbound Drug After Extravascular Administration for TAK-272F|CLu/F is the apparent clearance for unbound drug after extravascular administration of TAK-272.|Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||L/hr||Standard Deviation|Mean
2583366|NCT02367872|Primary|Apparent Clearance (CL/F) for TAK-272F||Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||liter per hour (L/hr)||Standard Deviation|Mean
2583367|NCT02367872|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-272F and Its Metabolite M-I||Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||hour||Full Range|Median
2583368|NCT02367872|Primary|AUC∞,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for TAK-272F|AUC∞,u is the area under the concentration-time curve of the unbound drug in plasma over the time interval from 0 to infinity of TAK-272.|Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||ng*hr/mL||Standard Deviation|Geometric Mean
2583369|NCT02367872|Primary|Cmax,u: Maximum Unbound Plasma Concentration for TAK-272F|Cmax,u is the peak unbound plasma concentration of a drug after administration, obtained directly from the unbound plasma concentration-time curve.|Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||ng/mL||Standard Deviation|Geometric Mean
2583370|NCT02367872|Primary|AUClast,u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration for TAK-272F|AUClast,u is the area under the concentration-time curve of the unbound drug in plasma over the time interval from 0 to time of last quantifiable post-dose of TAK-272.|Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||ng*hr/mL||Standard Deviation|Geometric Mean
2583371|NCT02367872|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-272F and Its Metabolite M-I||Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||ng*hr/mL||Standard Deviation|Geometric Mean
2583372|NCT02367872|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-272F and Its Metabolite M-I||Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2583373|NCT02367872|Primary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Free Form of TAK-272 (TAK-272F) and Its Metabolite M-I||Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose|The plasma PK set included all participants treated with the study drug who had no significant protocol deviation, satisfied the minimum protocol provisions, and could be evaluated for plasma PK.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2583374|NCT02367859|Secondary|Phosphorylation of Tumor Markers MEK and ERK|An immunohistochemical laboratory analysis to assess phosphorylation of the tumor markers MEK and ERK on the initial pre-treatment biopsy (baseline) vs either the endpoint tumor biopsy or the tumor specimen from the resection. Immunohistochemistry will be scored by at least 2 pathologists using percentage positive cells and intensity of staining as the primary metrics. Phosphorylation of MEK and ERK will be assessed as the observed difference in phosphorylated MEK and ERK labeling from baseline to the end of treatment (tumor biopsy or the tumor specimen). The outcome will be expressed as the mean, with standard deviation.|6 weeks|On the basis of futility due to study closure with inadequate accrual, post-surgical research specimens were not analyzed.||||||
2583397|NCT02367794|Secondary|OS in the TC2/3 or IC2/3 Population||Up to approximately 39 months after first participant enrolled||2020-10-31|10/2020||||
2583375|NCT02367859|Secondary|Change in Proliferation|An immunohistochemical laboratory analysis to assess proliferation will be performed on the initial pre-treatment biopsy (baseline) vs either the endpoint tumor biopsy or the tumor specimen from the resection. Ki-67 immunohistochemistry will be scored by at least 2 pathologists using percentage positive cells as the primary metric. Proliferation will be assessed as the difference from baseline in Ki-67 labeling to the end of treatment (tumor biopsy or the tumor specimen). The outcome will be expressed as the mean, with standard deviation.|6 weeks|On the basis of futility due to study closure with inadequate accrual, post-surgical research specimens were not analyzed.||||||
2583376|NCT02367859|Secondary|Percent Tumor Necrosis|Percent of tumor necrosis at the time of endpoint biopsy or surgical resection will be assessed. The tumor specimen from resection will be examined and the volume of the necrosis compared to the volume of the total tumor determined by central pathology. Percent tumor necrosis, in increments of 10%, will be determined. The outcome will be reported as the mean percent tumor necrosis, with standard deviation.|6 weeks|On the basis of futility due to study closure with inadequate accrual, post-surgical research specimens were not analyzed.||||||
2583377|NCT02367859|Primary|Tumor Response|"Tumor response was assessed per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Overall tumor response was assessed as the number of participants achieving either a complete response (CR) or a partial response (PR). The criteria are:~CR = Disappearance of all target lesions~PR = ≥ 30% decrease in the sum of the longest diameter of target lesions~Overall Response (OR) = CR + PR~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)~Stable disease (SD) = Small changes that do not meet any of the above criteria~The outcome is reported as the number of participants achieving the different levels of tumor response per RECIST, a number without dispersion."|6 weeks||||Participants|||Count of Participants
2583378|NCT02367833|Secondary|Changes in GH-stimulated IGF-1 Secretion|Changes in IGF-1, IGFBP-1, IGFBP-3,and ALS in response to exogenously administered GH before and after contraceptive therapy.|49 days of contraceptive therapy|No data was collected due to insufficient funds.||||||
2583379|NCT02367833|Secondary|Changes in Bone Turnover Markers|Changes in serially-sampled fasting serum concentrations of markers of bone formation (osteocalcin, P1NP) and bone resorption (NTx, and CTx) before and after contraceptive therapy.|Baseline and post-49 days of contraceptive therapy|No data was collected due to insufficient funds.||||||
2583380|NCT02367833|Primary|Changes in Insulin-like Growth Factor-1 (IGF-1), IGF Binding Proteins (IGFBP-1, IGFBP-3), and Acid Labile Subunit (ALS)|Changes in serially-sampled fasting serum concentrations of insulin-like growth factor-1 (IGF-1) before and after 49 days of contraceptive therapy. Data were only collected for IGF-1 levels, no assays were performed for IGFBP-1, IGFBP-3, and acid labile subunit (ALS) and no raw data were collected due to insufficient funds.|Baseline and post-49 days of contraceptive therapy||||ng/mL||Standard Error|Mean
2583381|NCT02367794|Secondary|Plasma Concentrations for Carboplatin||Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 15 to 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days)||2020-10-31|10/2020||||
2583382|NCT02367794|Secondary|Plasma Concentrations for Nab-Paclitaxel||Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 30 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days)||2020-10-31|10/2020||||
2583383|NCT02367794|Secondary|Plasma Concentrations for Paclitaxel||Prior to infusion (within same day of treatment administration), 5-10 minutes before the end of infusion, and 1 hour after the end of infusion (infusion duration 180 minutes) on Day 1 of Cycles 1 and 3 (each cycle is 21 days)||2020-10-31|10/2020||||
2583384|NCT02367794|Secondary|Minimum Observed Serum Atezolizumab Concentration (Cmin)|The predose samples will be collected on the same day of treatment administration.|Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle thereafter (up to 39 months), at treatment discontinuation (up to 39 months), and at 120 days after the last dose of atezolizumab (up to approximately 39 months, each cycle is 21 days)||2020-10-31|10/2020||||
2583385|NCT02367794|Secondary|Maximum Observed Serum Atezolizumab Concentration (Cmax)|The predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.|Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle up to 39 months; 30 minutes postdose on Day 1 of Cycles 1 and 3; at treatment discontinuation (up to 39 months), and at 120 days after last dose of atezolizumab (up to 39 months, each cycle is 21 days)||2020-10-31|10/2020||||
2583386|NCT02367794|Secondary|Percentage of Participants With Anti-therapeutic Antibody (ATA) Response to Atezolizumab|The predose samples will be collected on the same day of treatment administration.|Predose on Day 1 of Cycles 1-4, 8, 16, every 8 cycle thereafter (up to 39 months), at treatment discontinuation (up to 39 months), and at 120 days after the last dose of atezolizumab (up to approximately 39 months, each cycle is 21 days)||2020-10-31|10/2020||||
2583387|NCT02367794|Secondary|Percentage of Participants With Adverse Events||Up to approximately 39 months after first participant enrolled||2020-10-31|10/2020||||
2583388|NCT02367794|Secondary|OS in the ITT Population (Arm A vs. Arm B)||Up to approximately 39 months after first participant enrolled||2020-10-31|10/2020||||
2583389|NCT02367794|Secondary|PFS as Determined by the Investigator Using RECIST v1.1 in the ITT Population (Arm A vs. Arm B)||Up to approximately 30 months after first participant enrolled||2020-10-31|10/2020||||
2583390|NCT02367794|Secondary|Change From Baseline in Patient-reported Lung Cancer Symptoms Score Using the SILC Scale Symptom Severity Score in the ITT Population||Baseline up to approximately 30 months after first participant enrolled||2020-10-31|10/2020||||
2583391|NCT02367794|Secondary|TTD in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-LC13 Symptom Subscales in the ITT Population||Up to approximately 30 months after the first participant enrolled||2020-10-31|10/2020||||
2583392|NCT02367794|Secondary|Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Using EORTC QLQ-C30 Symptom Subscales in the ITT Population||Up to approximately 30 months after first participant enrolled||2020-10-31|10/2020||||
2583393|NCT02367794|Secondary|OS at 1 and 2 Years in the ITT Population|OS rates at 1 and 2 years is defined as the proportion of participants alive at 1 and 2 years after randomization estimated using Kaplan-Meier (KM) methodology for the ITT population|1 and 2 years||2020-10-31|10/2020||||
2583394|NCT02367794|Secondary|Duration of Response as Determined by the Investigator Using RECIST v1.1 in the ITT Population||Up to approximately 30 months after first participant enrolled||2020-10-31|10/2020||||
2583402|NCT02367794|Primary|Overall Survival (OS) in the ITT Population|OS is defined as the time between the date of randomization and date of death from any cause in the ITT population.|Up to approximately 39 months after first participant enrolled|Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received.|||Months||95% Confidence Interval|Median
2583403|NCT02367794|Primary|Progression Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population|PFS is defined as the time between the date of randomization and the date of first documented disease progression or death, whichever occurs first, in the ITT population.|Up to approximately 30 months after first participant enrolled|Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received.|||Months||95% Confidence Interval|Median
2583404|NCT02367781|Secondary|Plasma Concentrations of Nab-Paclitaxel Reported as Total Paclitaxel||Predose (same day of treatment administration), 5-10 minutes before end of nab-paclitaxel infusion, 1 h after nab-paclitaxel infusion (infusion duration=30 minutes) on D1 of Cy1,3 (1Cy=21 days) (up to approximately 56 months)||2020-12-31|12/2020||||
2583405|NCT02367781|Secondary|Plasma Concentrations of Carboplatin||Predose (same day of treatment administration), 5-10 minutes before end of carboplatin infusion, 1 h after carboplatin infusion (infusion duration=15 to 30 minutes) on D1 of Cy1,3 (1Cy=21 days) (up to approximately 56 months)||2020-12-31|12/2020||||
2583406|NCT02367781|Secondary|Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Atezolizumab+Carboplain+Nab-Paclitaxel|Predose samples will be collected on the same day of treatment administration.|Predose on D1 of Cy 1, 2, 3, 4, 8, 16 and every 8 cycles thereafter up to EOT (approximately 41 months), at 120 days after EOT (up to approximately 56 months)||2020-12-31|12/2020||||
2583407|NCT02367781|Secondary|Maximum Observed Serum Concentration (Cmax) of Atezolizumab for Patients in Atezolizumab+Carboplatin+Nab-Paclitaxel Arm|Predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes.|Predose on Day (D) 1 of Cycle (Cy) 1,2,3,4,8,16 and every 8 cycles thereafter up to end of treatment (EOT) (approximately 41 months), 0.5 hours (h) post-infusion on D1 of Cy1,3, at 120 days after EOT (up to approximately 56 months)||2020-12-31|12/2020||||
2583408|NCT02367781|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab||Up to approximately 56 months after first subject enrolled||2020-12-31|12/2020||||
2583409|NCT02367781|Secondary|Percentage of Participants With Adverse Events||Up to approximately 56 months after first subject enrolled||2020-12-31|12/2020||||
2583410|NCT02367781|Secondary|Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale||Up to approximately 56 months after first subject enrolled||2020-12-31|12/2020||||
2583411|NCT02367781|Secondary|Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms in the ITT-WT Population|Defined as time from randomization to confirmed deterioration (10-point change) on the combined European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire−Core (EORTC QLQ-C30) and supplemental lung cancer module (EORTC QLQ-LC13) symptom subscales.|Up to approximately 56 months after first subject enrolled||2020-12-31|12/2020||||
2583412|NCT02367781|Secondary|Percentage of Participants Who Are Alive at Year 1 and 2 in ITT-WT Population||Up to 56 months after first patient enrolled||2020-12-31|12/2020||||
2583413|NCT02367781|Secondary|Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 in ITT-WT Population||Up to approximately 56 months after first subject enrolled||2020-12-31|12/2020||||
2583414|NCT02367781|Secondary|Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using RECIST v1.1 in the ITT-WT Population||Up to approximately 56 months after first subject enrolled||2020-12-31|12/2020||||
2583415|NCT02367781|Secondary|OS as Determined by the Investigator Using Recist v1.1 in the ITT Population||Up to approximately 56 months after first subject enrolled||2020-12-31|12/2020||||
2583416|NCT02367781|Secondary|PFS as Determined by the Investigator Using Recist v1.1 in the ITT Population||Up to approximately 56 months after first subject enrolled||2020-12-31|12/2020||||
2583417|NCT02367781|Primary|Overall Survival (OS) in the ITT-WT Population|"OS is reported for the ITT-WT population. The term wild type (WT) refers to randomized participants who do not have a sensitizing EGFR mutation or ALK translocation."|Up to approximately 35 months after first patient enrolled||||Months||95% Confidence Interval|Median
2583418|NCT02367781|Primary|Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the ITT-WT Population|"PFS is reported for the ITT-WT population. The term wild type (WT) refers to randomized participants who do not have a sensitizing EGFR mutation or ALK translocation."|Up to approximately 35 months after first patient enrolled||||Months||95% Confidence Interval|Median
2583419|NCT02367729|Other Pre-specified|Questionnaire on Pediatric Gastrointestinal Symptoms, Rome III (QPGS-RIII), Reporting the Number of Participants With Specific Diagnoses|Nine-page, validated, parent-report questionnaire that assesses symptoms associated with pediatric functional GI disorders to diagnose the following specific Rome III criteria: Irritable Bowel Syndrome, Functional Dyspepsia, Abdominal Migraine, Functional Abdominal Pain and Functional Abdominal Pain Syndrome. The number of participants with these specific diagnoses at baseline were reported, including overlapping diagnoses.|Baseline only (diagnostic criteria)||||Participants|||Count of Participants
2583420|NCT02367729|Secondary|Functional Disability Inventory (FDI)|"15-item instrument, each question rated on a five-point scale (0=no trouble to 4=impossible), indicating how much difficulty subjects have doing common childhood activities because of their physical health. A total score is summed (range 0-60) with higher score indicating worse outcome (greater pain-related disability). Scored were compared before (Pre) and after (Post) treatment intervention."|Change from Baseline (Pre) to 2-3 months after end of therapy (Post)|Modified intent to treat population (all subjects who received minimum one week of therapy and with at least two available data points). Last observation carried forward (LOCF) imputation method.|||units on a scale||Inter-Quartile Range|Median
2583466|NCT02367352|Primary|Dose Expansion Phase: Cmax: Maximum Observed Plasma Concentration of Alisertib||Day 1 and Day 3 predose and at multiple time points (up to 12 hours) post-dose|The dose expansion phase was cancelled by the sponsor.||||||
2605715|NCT02107014|Primary|Change in EGF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2583421|NCT02367729|Secondary|Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Global Health (PGH-7)|A 7-item instrument that measures quality of life in relation to health. Each question has five response options (scored 1-5 units on a scale). A total raw sum score is generated, ranging from lowest score of 7 and highest score of 35 with higher scores indicating better outcome (improved quality of life). The raw score is converted to a standardized T-score (mean=50; standard deviation=10) based on a population of healthy children. T-scores were compared before (Pre) and after (Post) treatment intervention.|Change from Baseline (Pre) to 2-3 months after end of therapy (Post)|Modified intent to treat population (all subjects who received minimum one week of therapy and with at least two available data points). Last observation carried forward (LOCF) imputation method.|||T-score||Inter-Quartile Range|Median
2583422|NCT02367729|Secondary|State-Trait Anxiety Inventory for Children (STAI-C)|State-Trait Anxiety Inventory for Children (STAI-C). State anxiety measured by 20-item questionnaire assessing anxiety at a particular moment in time on a 3-point rating scale. Raw scores (range 20-60) were converted to normalized T-Scores based on a population of healthy school children (mean=50; standard deviation=10) with higher score indicating worse outcome. Effects of intervention on state anxiety was assessed before (pre) and after (post) therapy.|Change from Baseline (Pre) to 2-3 months after end of therapy (Post)|Modified intent to treat population (all subjects who received minimum one week of therapy and with at least two available data points). Last observation carried forward (LOCF) imputation method.|||T-score||Inter-Quartile Range|Median
2583423|NCT02367729|Secondary|Nausea Profile|Two page, 17-item questionnaire which measures the subjective experience of nausea on a scale from 0 (not at all) to 9 (severely) across three dimensions: 1) somatic distress; 2) gastrointestinal distress and 3) emotional distress. Total score 153.|Change from Baseline to week 4 in Nausea Profile score.|Modified intent to treat population (all subjects who received minimum one week of therapy and with at least two available data points). Last observation carried forward (LOCF) imputation method.|||units on a scale||Inter-Quartile Range|Median
2583424|NCT02367729|Primary|Pain Frequency-Severity-Duration Scale (PFSD) Score|One-page, 6-item pain measure assessing pain symptoms over the past week. Measures the typical and worst pain intensity, frequency and duration over the past week in units on a scale from 0 to 10 (10 being the worst pain imaginable). Worst pain = primary outcome.|Change from Baseline to Week 4|Modified intent to treat population (all subjects who received minimum one week of therapy and with at least two available data points). Last observation carried forward (LOCF) imputation method.|||units on a scale||Inter-Quartile Range|Median
2583425|NCT02367521|Secondary|Presence of Social Connections as Assessed by the Social Ties Checklist (STC)|The STC reflects the level of social contact. The score ranges from 0-10, with 0= excellent contact, 10=no contact. A higher score reflects poorer social contact.|Mean at baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
2583426|NCT02367521|Secondary|Overall Satisfaction With Life as Assessed by the Satisfaction With Life (SWL) Questionnaire|The SWL is a 7-point Likert-style response scale. The possible range of scores is 5-35, with a score of 20 representing a neutral point on the scale. Scores between 5-9 indicate the respondent is extremely dissatisfied with life, whereas scores between 31-35 indicate the respondent is extremely satisfied.|Mean at baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
2583427|NCT02367521|Secondary|Aggressive Behavior as Assessed by the Modified Overt Aggression Scale (MOAS)|MOAS measures four types of aggressive behavior as witnessed in the past week. Each section consists of five items, with the first section regarding verbal aggression, the second section focusing on aggression against property, the third section measuring autoaggression, and the fourth section concerning physical aggression. Participants are asked to check each item that is true over the last week. Items are allocated 0, 1, 2, 3 or 4 point(s), and then all points for each selected item are summed. The maximum total for each section is 10 if all items are selected. Total score ranges from 0-40 with a higher score indicating more aggressive behavior.|Mean at baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
2583428|NCT02367521|Secondary|Fatigue Severity as Assessed by the Fatigue Severity Scale (FSS)|The FSS is a 9-item questionnaire which measures the severity of fatigue and how it interferes with certain activities. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The score ranges from 9 to a maximum of 63. A higher score reflects greater fatigue severity.|Mean at baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
2583429|NCT02367521|Secondary|Presence of Post-concussive Symptoms as Assessed by the Rivermead Post-Concussion Questionnaire (RPQ)|Participants are asked to rate the severity of 16 different symptoms over the past 24 hours, on a severity scale from 0 to 4 (0 = not experienced, 1 = no more of a problem, 2 = mild problem, 3 = moderate problem, 4 = severe problem). The 16 symptoms include: headaches, dizziness, nausea and/or vomiting, hyperacusis, sleep disturbance, fatigue, being irritable, feeling depressed, feeling frustrated, forgetfulness, poor concentration, taking longer to think, blurred vision, light sensitivity, double vision, restlessness. Score ranges from 0 to 64, with a higher score reflecting increased severity of post-concussive symptoms.|Mean at baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
2583430|NCT02367521|Secondary|Presence of Neuropsychiatric Symptoms as Assessed by Neurobehavioral Rating Scale (NBRS)|The NBRS is a 28-item interview which includes a test of orientation and memory for recent events, questions regarding emotional state, post-concussional symptoms, focused attention, and concentration (performing serial sevens), explanation of proverbs, tasks of planning and mental flexibility, and delayed recall of three objects presented at the beginning of a session. Observations are also made regarding the patient's fatigability, visible signs of anxiety, disinhibition, agitation, hostility, difficulties in expressive and receptive communication, and disturbance of mood. The balance of the items are rated according to the patient's performance on brief tasks and quality of answers to interview questions. Each of the 28 items are scored on a scale of 0 (not severe) to 6 (extremely severe), for a maximum score of 168. A higher score reflects increased severity of neuropsychiatric symptoms.|Mean at baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
2583443|NCT02367521|Secondary|Cognitive Reasoning as Assessed by the Number of Errors Made on the Wisconsin Card Sorting Test (WCST)|The participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of errors, ranging from 0-128. A higher score reflects a poorer outcome.|Mean at baseline and 16 weeks||||errors||Standard Deviation|Mean
2583431|NCT02367521|Secondary|Mean Cognitive Function as Assessed by the Montreal Cognitive Assessment (MOCA)|"MOCA is designed to assess cognitive impairment and Alzheimer's Disease. It is composed of the following:~Visuospatial and Executive Functioning: 5 points Animal Naming: 3 points Attention: 6 points Language: 3 points Abstraction: 2 points Delayed Recall (Short-term Memory): 5 points Orientation: 6 points Education Level: 1 point is added to the test-taker's score if he or she has 12 years or less of formal education.~Score ranges 0-31, with ≥ 26 being normal cognitive function. The lower the score, the greater the level of cognitive impairment."|Mean at baseline and 16 weeks||||units on a scale||Standard Deviation|Mean
2583432|NCT02367521|Secondary|Mean Level of Fatigue as Assessed by the Epworth Sleepiness Scale (ESS)|The ESS is used to determine the level of daytime sleepiness. It is a questionnaire composed of 8 questions. The participant answers each question on a scale of 0 to 3 (0=no sleepiness, 1= mild sleepiness, 2= moderate sleepiness, 3= severe sleepiness). The total score is the sum of all responses for a maximum score of 24. A higher score reflects increased sleepiness.|Baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
2583433|NCT02367521|Secondary|Mean Level of Fatigue as Assessed by Patient Sleep Quality Index (PSQI)|"The PSQI score scale ranges from 0-21. 0 = very good sleep quality 21 = very bad sleep quality A total score of 5 or greater is indicative of poor sleep quality (reflecting a higher level of fatigue)"|Baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
2583434|NCT02367521|Secondary|Mean Trauma Severity as Assessed by the Davidson Trauma Scale (DTS)|"The DTS is a 17-item self-reported measure that assesses the 17 Diagnostic and Statistical Manual IV (DSM-IV) symptoms of post-traumatic stress disorder (PTSD).~Items are rated on 5-point frequency (0 = not at all to 4 = every day) and severity scales (0 = not at all distressing to 4 = extremely distressing).~The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). The severity score will be used to assess this outcome."|Baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
2583435|NCT02367521|Secondary|Mean Generalized Anxiety Disorder (GAD) - 7 Questionnaire|"The GAD-7 questionnaire is used as a screening tool and severity measure for generalized anxiety disorder. The scale ranges from 0 - 21.~0-4 = normal 5-9 = mild 10-14 = moderate >15 = severe"|Baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
2583436|NCT02367521|Secondary|Evaluation of Brain Injury as Assessed by the Trailmaking Test A Score|Trailmaking A is a psychological test with a score that is the number of seconds spent in connecting 25 numbered circles in sequential order. Score ranges from 0-150. Higher score reflects poorer outcome.|Mean at baseline and 16 weeks||||seconds||Standard Deviation|Mean
2583437|NCT02367521|Secondary|Immediate Recall as Assessed by Brief Visual Memory Test (BVMT)|BVMT is used to evaluate visuospatial memory abilities in neuropsychological populations. A visual display of six simple figures arranged in a 2 × 3 matrix on an 8 × 11 booklet is shown to participants for three consecutive 10-second trials. After each trial, participants are to draw as many designs as accurately as they can and in the correct location. Scoring of the immediate recall is based on the accuracy of the drawings and the location of the figures. For each figure, one point is awarded to each satisfactory domain resulting in a maximum of 12-points per trial, for a total score ranging from 0-36, with a higher score reflecting a better outcome.|Mean at baseline and 16 weeks||||accurately-drawn figures||Standard Deviation|Mean
2583438|NCT02367521|Secondary|Delayed Recall as Assessed by Brief Visual Memory Test (BVMT)|BVMT is used to evaluate visuospatial memory abilities in neuropsychological populations. A visual display of six simple figures arranged in a 2 × 3 matrix on an 8 × 11 booklet is shown to participants for three consecutive 10-second trials. After each trial, participants are to draw as many designs as accurately as they can and in the correct location after a 25-minute delay filled with other distractor tasks. Scoring of the delayed recall is based on the accuracy of the drawings and the location of the figures. For each figure, one point is awarded to each satisfactory domain resulting in a maximum of 12-points per trial for a total score range of 0-36, with higher scores indicating a better outcome.|Mean at baseline and 16 weeks||||accurately-drawn figures||Standard Deviation|Mean
2583439|NCT02367521|Secondary|Delayed Recall as Assessed by Hopkins Verbal Learning Test (HVLT)|"The HVLT consists of a 12-item word list, composed of four words from each of the three semantic categories. The subject is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The word list is then read to the subject at the approximate rate of one word every 2 seconds. This is done for three trials. After the third learning trial, the patient is read 24 words and is asked to say yes after each word that appeared on the recall list (12 targets) and no after each word that did not (12 distractors). Half of the distractors are drawn from the same semantic categories as the targets (related distractors) and half are drawn from other categories (unrelated distractors). The number of correctly-recalled words in each trial is recorded (maximum of 12 per trial). The score is the sum of all the correctly-recalled words from each trial, for a maximum of 36. T-scores are reported (average T-score of 50 (ranges 40-60)"|Mean at baseline and 16 weeks||||T-score of correctly-recalled words||Standard Deviation|Mean
2583440|NCT02367521|Secondary|Immediate Recall as Assessed by Hopkins Verbal Learning Test (HVLT)|The Hopkins Verbal Learning Test (HVLT) consists of a 12-item word list, composed of four words from each of the three semantic categories. The subject is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The word list is then read to the subject at the approximate rate of one word every 2 seconds. This is done for three trials. The number of correctly-recalled words in each trial is recorded (maximum of 12). The score is a sum of all the correctly-recalled words from each trial, for a maximum score of 36.|Mean at baseline and 16 weeks||||sum of correctly-recalled words||Standard Deviation|Mean
2583441|NCT02367521|Secondary|Evaluation of Brain Injury as Assessed by the Trailmaking Test B Score|The Trailmaking B score is the number of seconds spent connecting numbered circles (1-13) to circles containing letters of the alphabet (A-L) in alternating sequential order. A maximum of 300 seconds is allowed. Score ranges from 0-300. Higher score reflects poorer outcome.|Mean at baseline and 16 weeks||||seconds||Standard Deviation|Mean
2583442|NCT02367521|Secondary|Cognitive Reasoning as Assessed by the Number of Correct Trials on the Wisconsin Card Scoring Test (WCST)|The participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of correct trials, ranging from 0-128. A higher score reflects a better outcome.|Mean at baseline and 16 weeks||||correct trials||Standard Deviation|Mean
2583444|NCT02367521|Secondary|Cognitive Reasoning as Assessed by the Number of Completed Categories on the Wisconsin Card Scoring Test (WCST)|The participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of completed categories, ranging from 0-6. A higher score reflects a better outcome.|Mean at baseline and 16 weeks||||completed categories||Standard Deviation|Mean
2583445|NCT02367521|Secondary|Ability to Inhibit Cognitive Interference as Assessed by the Stroop Color Word Test (SCWT)|"The SCWT is used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Participants are required to read three different tables as fast as possible. Two of the tables represent the congruous condition in which participants are required to read names of colors printed in black ink and name different color patches. In the third table, incongruous condition the color-words are printed in a different color in (ie: the word red is printed in green ink). Within this third table, participants are required to name the color of the ink instead of reading the word. The score is based on the number of items completed, which ranges from 0 to 100, with a higher score reflecting a better outcome."|Mean at baseline and 16 weeks||||items completed||Standard Deviation|Mean
2583446|NCT02367521|Primary|Mean Suicidal Ideation as Assessed by the Beck Suicidal Ideation Scale (BSSI)|The BSSI scale is used to assess the degree of suicidal ideation. The scale ranges from 0-38, with 0= no suicidality, and 38 = highest severity of suicidal ideation|Mean at baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
2583447|NCT02367521|Primary|Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S)|"The CGI scale is broken down into the CGI-S and CGI-I components. CGI-S is the baseline severity of mental illness. 1= normal, not at all ill; 2= borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The CGI-S is only performed at baseline.~The CGI-I component (which is any measure after intervention) is as follows: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment."|Mean at baseline, 4, 8, 12, and 16 weeks||||units on a scale||Standard Deviation|Mean
2583448|NCT02367521|Primary|Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale|The HAM-D was used to determine the effectiveness of LFR rTMS for the treatment of post-TBI depression. The scale ranges from 0-54, with 0-7 = Normal; 8-13= Mild Depression; 14-18= Moderate Depression, 19-22= Severe Depression, >/= 23 = Very Severe Depression.|Mean at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks||||units on a scale||Standard Deviation|Mean
2583449|NCT02367430|Primary|Clutter Image Rating Scale|"Clutter Image Rating ScaleL Three sets of photographs, each containing nine photos of a single room with varying levels of clutter. A selection is made as to which photograph best resembles their own home.~This scale assesses the clutter levels in the bedroom, living room and kitchen. The scale for each room ranges from 1 to 9. Clutter that reaches the level 4 indicates significant difficulty with clutter that affects the person's life."|Baseline, 3 months, 6 months and 9 months||||units on a scale||Standard Deviation|Mean
2583450|NCT02367430|Primary|Savings Inventory-Revised|"The Saving Inventory-Revised scale (SI-R) is a 23-item questionnaire with 3 factor-analytically defined sub-scales for difficulty discarding, excessive clutter, and compulsive acquisition.~The total score (sum of 23 items) ranges from 0 to 92. Total score higher than 41 shows significant difficulty with clutter.~For the acquisition subscale we sum items 2 (reverse score), 9, 11, 14, 16, 18 and 21. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with excessive acquisition.~For the difficulty discarding subscale we sum items 4(reverse score), 6, 7, 13, 17, 19, 23. The subscale ranges from 0 to 28 and score greater than 13 indicates difficulty with discarding.~For the clutter subscale we sum items 1, 3, 5, 8, 10, 12, 15, 20, 22. The subscale ranges from 0 to 36 and score greater than 15 indicates difficulty with accumulated clutter."|Baseline, 3 months, 6 months and 9 months||||units on a scale||Standard Deviation|Mean
2583451|NCT02367391|Secondary|Total Score on the Positive Smoking Cessation Activities Measure|Total score for 6 items (scored 0-3). Total score range 0-18.|12 weeks|This data is presented for only participants who showed to Visit 2.|||activities||Standard Deviation|Mean
2583452|NCT02367391|Secondary|Time (in Days) to Relapse After the Target Quit Day||12 weeks||||days||Standard Deviation|Mean
2583453|NCT02367391|Secondary|Continuous Lapse-free Tobacco Abstinence From 4 Weeks to 12 Weeks, Biochemically Validated at Visit 2 and Visit 3.||12 weeks||||Participants|||Count of Participants
2583454|NCT02367391|Primary|Number of Active Smoking Cessation Activities Used|Number of activities completed out of 6|12 weeks|This data is presented for only participants who showed to Visit 2.|||activities||Standard Deviation|Mean
2583455|NCT02367391|Primary|Number of Days of Varenicline Use||12 weeks||||days||Standard Deviation|Mean
2583456|NCT02367391|Primary|Sustained Abstinence at the 12-week Follow up||12 weeks||||Participants|||Count of Participants
2583457|NCT02367391|Primary|Point Prevalence of 7-day Tobacco Abstinence Biochemically Validated by Exhaled CO < 10ppm at Visit 3 (12 Weeks After Target Quit Day)||12 weeks||||Participants|||Count of Participants
2583458|NCT02367352|Secondary|Dose Expansion Phase: Overall Response Rate (ORR)|ORR is defined as the percentage of participants with complete response (CR) and partial response (PR) according to disease response based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.|Day 21 of every other Cycle beginning with Cycle 2 (Up to 12 months)|The dose expansion phase was cancelled by the sponsor.||||||
2583459|NCT02367352|Primary|Dose Expansion Phase: T½: Terminal Phase Elimination Half-Life of Paclitaxel||Day 1 predose and Day 1, 2, and 3 at multiple time points (up to 12 hours) post-dose|The dose expansion phase was cancelled by the sponsor.||||||
2583460|NCT02367352|Primary|Dose Expansion Phase: AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of Paclitaxel||Day 1 predose and Day 1, 2, and 3 at multiple time points (up to 12 hours) post-dose|The dose expansion phase was cancelled by the sponsor.||||||
2583461|NCT02367352|Primary|Dose Expansion Phase: AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of Paclitaxel||Day 1 predose and Day 1, 2, and 3 at multiple time points (up to 12 hours) post-dose|The dose expansion phase was cancelled by the sponsor.||||||
2583467|NCT02367352|Primary|Dose Expansion Phase: Number of Participants With Clinically Significant Vital Sign Findings|The number of participants with any markedly abnormal vital sign values will be collected throughout study.|From Day 1 to 30 days after the last dose of study drug|The dose expansion phase was cancelled by the sponsor.||||||
2583468|NCT02367352|Primary|Dose Expansion Phase: Number of Participants With Clinically Significant Laboratory Findings|The number of participants with any markedly abnormal standard safety laboratory values will be collected throughout study.|From Day 1 to 30 days after the last dose of study drug|The dose expansion phase was cancelled by the sponsor.||||||
2583469|NCT02367352|Primary|Dose Expansion Phase: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.~A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|From Day 1 to 30 days after the last dose of study drug|The dose expansion phase was cancelled by the sponsor.||||||
2583470|NCT02367352|Primary|Dose Escalation Phase: T½: Terminal Phase Elimination Half-Life of Paclitaxel||Day 1 predose and Day 1, 2, and 3 at multiple time points (up to 12 hours) post-dose|Pharmacokinetic data was not available as 9 participants were insufficient sample size to run the analysis.||||||
2583471|NCT02367352|Primary|Dose Escalation Phase: AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Tme 0 to Infinity||Day 1 predose and Day 1, 2, and 3 at multiple time points (up to 12 hours) post-dose|Pharmacokinetic data was not available as 9 participants were insufficient sample size to run the analysis.||||||
2583472|NCT02367352|Primary|Dose Escalation Phase: AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of Paclitaxel||Day 1 predose and Day 1, 2, and 3 at multiple time points (up to 12 hours) post-dose|Pharmacokinetic data was not available as 9 participants were insufficient sample size to run the analysis.||||||
2583473|NCT02367352|Primary|Dose Escalation Phase: Tmax: Time to Reach the Maximum Plasma Concentration of Paclitaxel||Day 1 predose and Day 1, 2, and 3 at multiple time points (up to 12 hours) post-dose|Pharmacokinetic data was not available as 9 participants were insufficient sample size to run the analysis.||||||
2583474|NCT02367352|Primary|Dose Escalation Phase: Cmax: Maximum Observed Plasma Concentration of Paclitaxel||Day 1 predose and Day 1, 2 and 3 at multiple time points (up to 12 hours) post-dose|Pharmacokinetic data was not available as 9 participants were insufficient sample size to run the analysis.||||||
2583475|NCT02367352|Primary|Dose Escalation Phase: AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Alisertib||Day 1 and Day 3 predose and at multiple time points (up to 12 hours) post-dose|Pharmacokinetic data was not available as 9 participants were insufficient sample size to run the analysis.||||||
2583476|NCT02367352|Primary|Dose Escalation Phase: Tmax: Time to Reach the Maximum Plasma Concentration of Alisertib||Day 1 and Day 3 predose and at multiple time points (up to 12 hours) post-dose|Pharmacokinetic data was not available as 9 participants were insufficient sample size to run the analysis.||||||
2583477|NCT02367352|Primary|Dose Escalation Phase: Cmax: Maximum Observed Plasma Concentration of Alisertib||Day 1 and Day 3 predose and at multiple time points (up to 12 hours) post-dose|Pharmacokinetic data was not available as 9 participants were insufficient sample size to run the analysis.||||||
2583478|NCT02367352|Primary|Dose Escalation Phase: Number of Participants With Clinically Significant Vital Sign Findings|The number of participants with any markedly abnormal vital sign values (blood pressure, heart rate, and temperature) will be collected throughout study. Vital signs assessed by the investigator to be clinically significant were reported as adverse events.|From Day 1 to 30 days after the last dose of study drug (approximately 21 months)|Safety population is defined as all participants who received at least 1 dose of alisertib. No participants were enrolled in Dose Escalation Phase Cohort 2.|||Participants|||Count of Participants
2583479|NCT02367352|Primary|Dose Escalation Phase: Number of Participants With Clinically Significant Laboratory Findings|The number of participants with any markedly abnormal standard safety laboratory values including serum chemistry, hematology, and urine analysis will be collected throughout study. Laboratory values assessed by the investigator to be clinically significant were reported as adverse events.|From Day 1 to 30 days after the last dose of study drug (approximately 21 months)|Safety population is defined as all participants who received at least 1 dose of alisertib. No participants were enrolled in Dose Escalation Phase Cohort 2.|||Participants|||Count of Participants
2583480|NCT02367352|Primary|Dose Escalation Phase: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.~A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|From Day 1 to 30 days after the last dose of study drug (approximately 21 months)|Safety population is defined as all participants who received at least 1 dose of alisertib. No participants were enrolled in Dose Escalation Phase Cohort 2.|||Participants|||Count of Participants
2583481|NCT02367170|Secondary|A Change in the Urinary Excretion Markers of Muscle Catabolism From Baseline|Investigators will determine the effects of IMST on urinary excretion markers of muscle catabolism in patients with CCI. Investigators hypothesize that exercise will decrease urinary markers of catabolism compared to the SHAM condition.|Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21|||||||
2583482|NCT02367170|Secondary|A Change in the Results of the Biomarkers of Inflammation From Baseline|Investigators will determine the effects of IMST on biomarkers of inflammation in patients with CCI. Investigators hypothesize that exercise will decrease markers of inflammation compared to the SHAM condition.|Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21|||||||
2583483|NCT02367170|Primary|A Change in Diaphragm Strength From Baseline as an Effect of Inspiratory Muscle Strength Training (IMST) Intervention and Sham Patients|In this randomized, interventional study, 24 CCI patients will be assigned to either a sham group or to receive IMST for up to 28 days. Evaluation of diaphragm/inspiratory muscle strength and muscle thickness will be made with three techniques: 1) non-volitional magnetic stimulation of the phrenic nerves, 2) noninvasive measurement of diaphragm thickness with ultrasound and 3) the standard, clinical method of measuring maximal inspiratory pressure (MIP). Investigators hypothesize that IMST will lead to improvements in all three measures. This study will provide information about possible effective respiratory muscle rehabilitation techniques that are likely to lead to reduced time patients will require mechanical ventilation and improved MIP and weaning outcome in long-term, failure to wean patients|Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15, Day 17, Day 19, Day 21, Day 23, Day 25, Day 28|Unable to recruit sufficient number of patients.||||||
2583484|NCT02367131|Secondary|Change From Baseline in Fasting Plasma Glucose at the Last Observation During the Observation Period|Change from baseline in Fasting plasma glucose at the last observation during the observation period.|Baseline and last observation on treatment, up to week 52|Efficacy set|||mg/dL||Standard Deviation|Mean
2583485|NCT02367131|Secondary|Change From Baseline in HbA1c at the Last Observation During the Observation Period|Change from baseline in haemoglobin A1c (HbA1c) at the last observation during the observation period|Baseline and last observation on treatment, up to week 52|Efficacy Set: This analysis set is a subset of the safety set, which included all patients in the “safety set” except those who had no available efficacy data.|||Percentage||Standard Deviation|Mean
2583486|NCT02367131|Primary|Percentage of Patients With Adverse Drug Reactions (ADRs)|Percentage of patients with drug related Adverse events|From first drug administration until 7 days after last drug adminstration, up to 52 weeks|Safety set|||Percentage of participants|||Number
2583487|NCT02367066|Secondary|Apparent Oral Plasma AZD1981 at Steady-State, CL_ss/F||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||L/h||Standard Deviation|Mean
2583488|NCT02367066|Secondary|Plasma AZD1981 AUC(0-24h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2583489|NCT02367066|Secondary|Plasma AZD1981 AUC(0-12h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2583490|NCT02367066|Secondary|Plasma AZD1981 AUC(0-4h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2583491|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(0-24h) for Plasma Glucose||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*mmol/L||Standard Deviation|Geometric Mean
2583492|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma C-Peptide||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*pmol/L||Standard Deviation|Geometric Mean
2583493|NCT02367066|Secondary|Plasma Paracetamol AUC(0-t)||Days 3,9|One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.|||h*ng/ML||Geometric Coefficient of Variation|Geometric Mean
2583494|NCT02367066|Secondary|Time of Maximum Plasma Paracetamol Concentration, t_max||Days 3,9|One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.|||h||Full Range|Median
2583495|NCT02367066|Secondary|Plasma Paracetamol Maximum Concentration, C_max||Days 3,9|One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2583496|NCT02367066|Secondary|Plasma AZD1981 AUC(1-2h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2583497|NCT02367066|Secondary|Minimum Plasma AZD1981 Concentration at Steady-State, C_ss,Min||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2583498|NCT02367066|Secondary|Plasma AZD1981 AUC(0-2h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2583499|NCT02367066|Secondary|Plasma AZD1981 AUC(0-1h)||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||h*nmol/L||Geometric Coefficient of Variation|Geometric Mean
2583500|NCT02367066|Secondary|Time of Maximum Plasma AZD1081 Concentration, t_ss,Max||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||h||Full Range|Median
2583501|NCT02367066|Secondary|Maximum Plasma AZD1981 Concentration at Steady-State, C_ss,Max||Days 2,3,8,9|One value per subject and method (MMTT/GGI). Value calculated on days 2 and 3 if subject in sequence AZD1981-Placebo or on days 8 and 9 if subject in sequence Placebo-AZD1981.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2583502|NCT02367066|Secondary|Fasting Insulin at Endpoint||Day 3 and Day 9|One value per subject and treatment. AZD1981 value calculated at Day 3 if subject in sequence AZD1981-Placebo or at Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day 3 if subject in sequence Placebo-AZD1981 or at Day 9 if subject in sequence AZD1981-Placebo.|||UIU/ML||Standard Error|Least Squares Mean
2583503|NCT02367066|Secondary|Change From Baseline to Endpoint Fasting Beta-cell Responsiveness||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||10^-9*(L/kg)*min||Standard Error|Least Squares Mean
2583504|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Glucagon||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*mmol/L||Standard Deviation|Geometric Mean
2583505|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Glucagon||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*mmol/L||Standard Deviation|Geometric Mean
2583506|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma Insulin||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*mU/L||Standard Deviation|Geometric Mean
2583507|NCT02367066|Secondary|Change From Baseline to Endpoint GGI AUC(0-1h) for Plasma Insulin||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*mU/L||Standard Deviation|Geometric Mean
2583508|NCT02367066|Secondary|Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma C-Peptide||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*pmol/L||Standard Deviation|Geometric Mean
2583509|NCT02367066|Secondary|Change From Baseline MMTT AUC(0-4h) for Plasma Glucagon||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*pmol/L||Standard Deviation|Geometric Mean
2583510|NCT02367066|Secondary|Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Insulin||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*mU/L||Standard Deviation|Geometric Mean
2583511|NCT02367066|Primary|Change From Baseline to Endpoint GGI AUC(1-2h) for Plasma C-Peptide|GGI=Glucose and GLP1 infusion AUC=Area Under Curve|Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*pmol/L||Standard Deviation|Geometric Mean
2583512|NCT02367066|Primary|Change From Baseline to Endpoint MMTT C_max for Plasma Glucose||Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||nmol/L||Standard Deviation|Geometric Mean
2583513|NCT02367066|Primary|Change From Baseline to Endpoint MMTT AUC(0-4h) for Plasma Glucose|MMTT=Mixed Meal Tolerance Test AUC=Area Under Curve|Day -1 to Day 3 and Day 6 to Day 9|One value per subject and treatment. AZD1981 value calculated at Day -1 to Day 3 if subject in sequence AZ1981-Placebo or at Day 6 to Day 9 if subject in sequence Placebo-AZD1981. Placebo value calculated at Day -1 to Day 3 if subject in sequence Placebo-AZD1981 and at Day 6 to Day 9 if subject in sequence AZD1981-Placebo.|||h*nmol/L||Standard Deviation|Geometric Mean
2583514|NCT02367014|Secondary|Change in Eosinophils (10^9 Cells/L)|Change in eosinophils as measured by (10^9 cells/L) from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom eosinophils was measured|||10^9 cells/L||Standard Deviation|Mean
2583515|NCT02367014|Secondary|Change in Aspartate Aminotransferase (AST) (U/L)|Change in aspartate aminotransferase (AST) as measured by U/L from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom aspartate aminotransferase was measured|||U/L||Standard Deviation|Mean
2583516|NCT02367014|Secondary|Change in Alanine Aminotransferase (ALT) (U/L)|Change in Alanine aminotransferase (ALT) as measured by (U/L) from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom Alanine aminotransferase was measured|||U/L||Standard Deviation|Mean
2583517|NCT02367014|Secondary|Change in Creatine Phosphokinase (IU/L)|Change in Creatine Phosphokinase as measured by IU/L from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom creatine phosphokinase was measured|||IU/L||Standard Deviation|Mean
2583518|NCT02367014|Secondary|Number of Participants Who Had Suicide Ideation, Suicidal Behavior, or Non-suicidal Self-injurious Behavior Post-screening.|Number of participants with suicide ideation, suicidal behavior, or non-suicidal self-injurious behavior post-screening as measured on Days 1-5, and Day 7 on the Columbia Suicide Severity Rating Scale (CSSRS). A yes/no binary response is utilized in the following ten categories: 1 - Wish to be Dead; 2 - Non‐specific Active Suicidal Thoughts; 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; 5 - Active Suicidal Ideation with Specific Plan and Intent; 6 - Preparatory Acts or Behavior; 7 - Aborted Attempt; 8 - Interrupted Attempt; Category 9 - Actual Attempt (non‐fatal); 10 - Completed Suicide. A yes/no binary response is also utilized in assessing self‐injurious behavior without suicidal intent. A lower score means a better outcome whereas a higher score means a worse outcome.|Days 1-5 and Day 7.|Participants for whom CSSR was measured.|||Participants|||Count of Participants
2583519|NCT02367014|Secondary|Change in ECG-QTc Interval (Msec)|Change in QTc interval as measured by ECG in msec from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom QTc interval was measured|||msec||Standard Deviation|Mean
2583520|NCT02367014|Secondary|Change in ECG-QT Interval (Msec)|Change in QT interval as measured by ECG in msec from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom QT interval was measured|||msec||Standard Deviation|Mean
2583521|NCT02367014|Secondary|Change in ECG-QRS Complex (Msec)|Change in QRS complex as measured by ECG in msec from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom QRS complex was measured|||msec||Standard Deviation|Mean
2583522|NCT02367014|Secondary|Change in ECG-PR Interval (Msec)|Change in PR interval as measured by ECG in milliseconds from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom PR interval was measured|||msec||Standard Deviation|Mean
2583523|NCT02367014|Secondary|Change in Temperature (°C)|Change in temperature as measured by units of Celsius from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom temperature was measured|||°C||Standard Deviation|Mean
2583524|NCT02367014|Secondary|Change in Watts|Change in watts from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom watts was measured|||watts||Standard Deviation|Mean
2583525|NCT02367014|Secondary|Change in VO2 Anaerobic Threshold (mL)|Change in VO2 anaerobic threshold as measured by mL from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom VO2 was measured.|||mL||Standard Deviation|Mean
2583526|NCT02367014|Secondary|Change in Peak Borg Dyspnea|Change in peak Borg dyspnea as measured by 0-10 with 0 meaning no breathlessness and 10 meaning maximal breathlessness from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom peak Borg dyspnea was measured.|||Units on a scale||Standard Deviation|Mean
2583527|NCT02367014|Secondary|Change in Peak Diastolic Blood Pressure (mmHg)|Change in peak diastolic blood pressure as measured by mmHg from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom peak diastolic blood pressure was measured|||mmHg||Standard Deviation|Mean
2583528|NCT02367014|Secondary|Change in Peak Systolic Blood Pressure (mmHg)|Change in peak systolic blood pressure as measured by mmHg from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom peak systolic blood pressure was measured.|||mmHg||Standard Deviation|Mean
2583529|NCT02367014|Secondary|Change in Peak Oxygen Saturation (% O2-saturated Hemoglobin)|Change in peak oxygen saturation as measured by percentage of O2-saturated hemoglobin from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom peak oxygen saturation was measured.|||percentage of O2-saturated hemoglobin||Standard Deviation|Mean
2583530|NCT02367014|Secondary|Change in Peak Heart Rate (Beats/Min)|Change in peak heart rate as measured by beats per minute from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom peak heart rate was measured|||beats/min||Standard Deviation|Mean
2583531|NCT02367014|Secondary|Change in Peak Ventilation (L/Min)|Change in peak ventilation as measured by L/min from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom peak ventilation was measured.|||L/min||Standard Deviation|Mean
2583532|NCT02367014|Secondary|Change in Peak Respiratory Rate (Breaths/Min)|Change in peak respiratory rate as measured by breaths/min from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom peak respiratory rate was measured|||breaths/min||Standard Deviation|Mean
2583533|NCT02367014|Secondary|Change in Peak Respiratory Exchange Ratio (VCO2/VO2)|Change in peak respiratory exchange ratio as measured by VCO2/VO2 from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom peak respiratory exchange ratio was measured.|||VCO2/VO2 ratio||Standard Deviation|Mean
2583534|NCT02367014|Secondary|Change in Post-exercise Lactate Levels (mg/dL)|Change in post-exercise lactate levels as measured by mg/dL from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom post- exercise lactate levels were measured|||mg/dL||Standard Deviation|Mean
2583535|NCT02367014|Secondary|Change in Pre-exercise Lactate Levels (mg/dL)|Change in pre-exercise lactate levels as measured by mg/dL from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom pre-exercise lactate levels were measured|||mg/dL||Standard Deviation|Mean
2583536|NCT02367014|Secondary|Change in Oxygen Uptake Kinetics (Mean Response Time as Measured by Seconds)|Change in oxygen uptake kinetics (mean response time) as measured by seconds from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|Participants for whom oxygen uptake kinetics was measured|||seconds||Standard Deviation|Mean
2583537|NCT02367014|Secondary|Change in Oxygen Utilization (ΔVO2/ΔlogVE Ratio)|Change in oxygen utilization as measured by ΔVO2/ΔlogVE ratio from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|All participants for whom oxygen utilization measurements were recorded at Baseline and Day 5|||ΔVO2/ΔlogVE ratio||Standard Deviation|Mean
2583538|NCT02367014|Secondary|Change in Aerobic Efficiency (ΔO2 Consumption/Δ Work Ratio)|Change in aerobic efficiency as measured by ΔO2 consumption/Δ work ratio from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|All participants for whom aerobic efficiency measurements were recorded at Baseline and Day 5|||ΔO2 consumption/Δwork ratio||Standard Deviation|Mean
2583539|NCT02367014|Secondary|Change in Ventilatory Efficiency (VE/VCO2 Slope)|Change in ventilatory efficiency as measured by the VE/VCO2 slope from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|All participants for whom VE/VCO2 slope measurements were recorded at Baseline and Day 5|||VE/VCO2 slope||Standard Deviation|Mean
2583540|NCT02367014|Secondary|Change in Maximum Oxygen Uptake (ml/kg/Min)|Change in maximum oxygen uptake as measured by mL/kg/min from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Baseline, Day 5|All participants for whom maximum oxygen uptake was measured at baseline and Day 5|||ml/kg/min||Standard Deviation|Mean
2583541|NCT02367014|Primary|Change in Distance Walked (Meters) on the 6-minute Walk Test (6MWT)|Change in distance walked as measured by meters on the 6-minute walk test from baseline (last assessment prior to start of study) to Day 5 (end of treatment visit).|Assessed at Baseline, Day 5 (end-of-treatment visit)||||meters||Full Range|Least Squares Mean
2583542|NCT02366936|Primary|Number of Infants That Developed Dolichocephaly by the End of the Study|dolichocephaly for this study is considered a cranial Index <76% at 34 weeks post menstrual age (PMA)|34 weeks gestational age||||participants|||Number
2583543|NCT02366936|Primary|Cranial Index (CI)|"CI was determined by calculating the ratio of the biparietal diameter (BiPD) over the occipitofrontal diameter (OFD). The BiPD is defined as the widest transverse diameter of the head. BiPD was measured from the most prominent lateral point on each side of the skull in the area of parietal and temporal bones. The OFD is defined as the diameter of the head from the most prominent midline point of the frontal bone (glabella) to the occipital protuberance. While various reported ranges exist for cranial molding norms, dolichocephaly was defined as a CI of <76%. The normative CI range is 76-85% for prone and supine sleeping infants.~CI = BPD/OFD x 100"|34 weeks gestational age||||cranial index||Full Range|Median
2583544|NCT02366923|Primary|Moisture Retention (Median) of Stenfilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).|12 Hours of Wear|There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.|||percentage of dehyrdation||Full Range|Median
2583545|NCT02366923|Primary|Moisture Retention (Mean) of Stenfilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).|12 Hours of Wear|There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.|||percentage of dehyrdation||Standard Deviation|Mean
2583546|NCT02366923|Primary|Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).|12 Hours of Wear|There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.|||absolute WC change||Full Range|Median
2583547|NCT02366923|Secondary|Subjective Comfort of Stenfilcon A and Delefilcon A|Subjective ratings for stenfilcon A and delefilcon A assessed at every hour up to 12 hours. (Scale 0-100, 0=very poor 100=excellent)|Up to 12 Hours of Wear||||units on a scale||Standard Deviation|Mean
2583548|NCT02366923|Primary|Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).|12 Hours of Wear|There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. The sample size for statistical analysis is reduced to 18 pairs.|||absolute WC change||Standard Deviation|Mean
2583549|NCT02366910|Primary|Moisture Retention (Median) of Omafilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).|12 Hours|Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.|||percentage of dehyrdation||Full Range|Median
2583550|NCT02366910|Primary|Moisture Retention (Mean) of Omafilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).|12 Hours|Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.|||percentage of dehyrdation||Standard Deviation|Mean
2583551|NCT02366910|Primary|Absolute Change in Water Content (Median) of Omafilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).|12 Hours of Wear|Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.|||absolute WC change||Full Range|Median
2583552|NCT02366910|Primary|Absolute Change in Water Content (Mean) of Omafilcon A and Delefilcon A|Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).|12 Hours of Wear|Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.|||absolute WC change||Standard Deviation|Mean
2583567|NCT02366689|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|3 months||||units on a scale||Standard Deviation|Mean
2583553|NCT02366871|Secondary|Change in Quality of Life From Baseline to 28 Days Post-op|This was measured through a validated health survey (SF-8™) provided by a healthcare company (Optum®), which measured overall physical and mental well-being, with responses ranging from none to very, not at all to extremely, etc. Change was calculated as the difference at baseline versus 28 days post op. The score was 0-100 and a higher score was considered a better outcome.|At baseline, and visit 4, which is 28 days (+/- 4 days) post-op/standard of care||||score on a scale||Inter-Quartile Range|Median
2583554|NCT02366871|Secondary|Number of Participants With a Patient Satisfaction Assessment|Participants were monitored at the 28 (+/- 4) day post-op visit. This was measured through administering a participant satisfaction questionnaire ranging from strongly agree to strongly disagree.This is the number of participants that completed the questionnaire in response to agreeing it was difficult to remember to take the medication, agreeing that there was pain associated with the medication, and agreeing that the medication was easy to use.|On visit 4, which is 28 days (+/- 4 days) post-op/standard of care|"One patient did not answer the pain associated with taking the medication category."|||Participants|||Count of Participants
2583555|NCT02366871|Secondary|Number of Participants Who Met Medication Adherence Rates|Participants were monitored for up to 28 days. This was measured through self-report, patient diaries, and the return of all medication bottles/syringes. This was the number of participants that did not miss more than 2 days of study medication over 28 days (less than 4 pills or 2 injections missed).|Day 1 post-op/standard of care first dose of medication to Day 28 (+/- 4 days) post-op/standard of care||||Participants|||Count of Participants
2583556|NCT02366871|Secondary|Number of Participants With Incidence of Venous Thromboembolism (VTEs): Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)|Participants were monitored for up to 90 days. Both DVTs and PEs will be measured using the Wells criteria, ultrasound, and/or CT. This is the number of participants who had at least one DVT or PE during the time of observation.|Day 1 post-op/standard of care to day first dose of medication 90 (+/- 14 days) post-op/standard of care||||Participants|||Count of Participants
2583557|NCT02366871|Primary|Number of Participants With Incidence of Clinically Relevant Non Major Bleeding Events|Participants were monitored for up to 90 days. This is the number of participants with bleeding events that did not meet the ISTH criteria but still required intervention. This is the number of participants who had at least one non-major bleeding event during the time of observation.|Day 1 post-op/standard of care first dose of medication to day 90 (+/- 14 days) post-op/standard of care||||Participants|||Count of Participants
2583558|NCT02366871|Primary|Number of Participants With Incidence of Major Bleeding|The International Society on Thrombosis and Hemostasis criteria (ISTH) will be used to assess incidence of major bleeding. Participants were monitored for up to 90 days. This is the number of participants who have had at least one major bleeding incidence during the time of observation.|Day 1 post-op/standard of care first medication dose to day 90 (+/-14 days) post-op/standard of care||||Participants|||Count of Participants
2583559|NCT02366845|Secondary|Hospital Length of Stay||Subjects will be followed for duration of hospital stay, anticipated within 1 Day to 28 Days||||days||95% Confidence Interval|Mean
2583560|NCT02366845|Secondary|Dose Difference (Average # Units) Between Clinician Dosing and Algorithm Dosing (Units of FFP) Per Patient.||within 1 hour after entire plasma transfusion||||units||95% Confidence Interval|Mean
2583561|NCT02366845|Secondary|Time (Hours) From Initiation of First Dose of Plasma to Initiation of Planned Procedure (in Patient Undergoing Transfusion Before a Procedure) for Clinician Dosing Compared to Algorithm Dosing Strategies.|Decreased time between initiation of plasma infusion, achieving a corrected target INR and start of planned patient procedures would potentially improve care efficiency and/or allow faster intervention in unstable patients.|hours from first dose to initiation of procedure, anticipated timeframe between 1 minute to 8 hours.||||hours||95% Confidence Interval|Mean
2583562|NCT02366845|Primary|Number of Participants That Reached Targeted International Normalized Ratio (INR) Within ±0.1 After First Fresh Frozen Plasma (FFP) Transfusion Completed.|"Ability of dosing algorithm to accurately predict necessary plasma dose (ml/kg), required to reach commonly targeted International Normalized Ratio (INR) values, compared to clinician chosen plasma transfusion dose, as determined by dose-response curve.~The primary outcome was achievement of the target INR within ±0.1 after the first round of FFP transfusion. This primary outcome was selected because underdosing can result in prolonged bleeding, delayed procedure times, and more rounds of FFP transfusion. Furthermore, overdosing can result in excess cost, increased portal pressures, bleeding, transfusion associated circulatory overload (TACO), and transfusion related acute lung injury (TRALI)."|within 1 hour after entire plasma transfusion|At goal INR after first transfusion.|||Participants|||Count of Participants
2583563|NCT02366767|Secondary|Efficacy of Hybrid Closed-loop System in Comparison With Control|As measured by overall mean sensor glucose percent time in range 70-180 mg/dL.|6 days|Including only sensor data where the daily median ARD <15%.|||Percent time||Standard Error|Mean
2583564|NCT02366767|Secondary|Feasibility of Using the Automatic Closed Loop Delivery System in Adolescents and Adults With Type 1 Diabetes|"As measured by the system initiating and operating properly for at least 75% of the time for 75% of subjects.~As measure by the completion of study enrollment procedures and education on system use within 2 hours for 75% of the subjects."|6 days||||participants|||Number
2583565|NCT02366767|Primary|Safety of Automatic Closed Loop Insulin Delivery System in Adolescents and Adults With Type 1 Diabetes|"As measured by the number of events of plasma glucose values ≤ 50 mg/dL OR frequency of system alerts preceding a plasma glucose value of ≤ 50 mg/dL in all subjects~As measured by the number of events of system alerts of plasma glucose values >300 mg/dL lasting for more than one hour in all subjects.~As measured by number of events of serum ketones >3 mmol/L in all subjects~As measured by the number of events meeting the criteria for severe hypoglycemia, defined as hypoglycemic seizure, loss of consciousness or coma or an event requiring administration of glucagon or IV glucose in all subjects"|6 days|10 subjects who completed study|||Events|||Number
2583566|NCT02366689|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 months||||units on a scale||Standard Deviation|Mean
2583568|NCT02366689|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|Baseline||||units on a scale||Standard Deviation|Mean
2583569|NCT02366689|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 months||||units on a scale||Standard Deviation|Mean
2583570|NCT02366689|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|3 months||||units on a scale||Standard Deviation|Mean
2583571|NCT02366689|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Baseline||||units on a scale||Standard Deviation|Mean
2583572|NCT02366663|Secondary|Cumulative Incidence of New, Abnormal Cytogenetics|The cumulative incidence of therapy related new, abnormal cytogenetics will be estimated for both groups taking into account the competing risk of death among patients who do not develop a second malignancy.|Day 0 to Year 5 post-HCT|The study was terminated before the data are mature enough to estimate the cumulative incidence and conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.||||||
2583573|NCT02366663|Secondary|Number of Patients With Grade 3-5 Toxicities Graded by the NCI CTCAE Version 4.0|Observed toxicities will be summarized in terms of type and severity. In accordance with the secondary study objectives, descriptive analyses on these data will be performed.|Day -21 to Day +100 post-HCT|Number of patients with grade 3, 4 or 5 toxicities in each arm, are reported below.|||Participants|||Count of Participants
2583574|NCT02366663|Secondary|Time to Platelet Engraftment|Time to platelet engraftment will be compared between treatment arms using a log-rank test, and the cumulative incidence curves will be estimated.|Day 0 to Day 100 post-HCT|The study was terminated before the data are mature enough to estimate the cumulative incidence and conduct the test. Therefore, the descriptive analysis was performed. The median time to platelet engraftment and range are reported below.|||days||Full Range|Median
2583575|NCT02366663|Secondary|Cumulative Incidence of Secondary Malignancies|Incidence of myelodysplastic syndrome (MDS), and secondary acute Myelogenous leukemia (AML) will be compared between the treatment arms using Gray's test.|Up to 5 years|The study was terminated before the data are mature enough to estimate the cumulative incidence and conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.||||||
2583576|NCT02366663|Secondary|Incidence of Non-relapse Mortality (NRM) Defined as Death Occurring in a Patient From Causes Other Than Relapse or Progression|The cumulative incidence of NRM will be estimated using the method described by Gooley et al. Differences between cumulative incidence curves in the presence of a competing risk will be tested using the Gray method.|From randomization until non-disease related death, or last follow-up, whichever comes first, assessed up to 5 years|The study was terminated before the data are mature enough to estimate the cumulative incidence and conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.||||||
2583577|NCT02366663|Secondary|Incidence of Infection|Microbiologically documented infections will be reported by site of disease, date of onset, severity, and resolution, if any. The incidence of definite and probable viral, fungal and bacterial infections will be tabulated for each patient. The proportion of patients developing infections will be compared between treatment arms.|Day 0 to Day +100 post-HCT|The study was terminated before the data are mature enough to conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.||||||
2583578|NCT02366663|Secondary|Time to Neutrophil Engraftment|Time to neutrophil engraftment will be compared between treatment arms using a log-rank test, and the cumulative incidence curves will be estimated.|Day 0 to Day 100 post-HCT|The study was terminated before the data are mature enough to estimate the cumulative incidence and conduct the test. Therefore, the descriptive analysis was performed. The median time to ANC engraftment and range are reported below.|||days||Full Range|Median
2583579|NCT02366663|Secondary|Number of Patients With Complete or Partial Response at Day 30|Definition of disease status is based on the article of Revised Response Criteria for Malignant Lymphoma Response Definitions for Clinical Trials (Cheson et al, 2007). Tests used for evaluation of disease status would be physical examination, laboratory testing, bone marrow testing, bone marrow biopsy and aspirate, PET scan, and CT scans of neck, chest, abdomen and pelvis as indicated.|Day 0 to Day +30 post-HCT|In Arm I (ZBEAM), one patient's disease status at Day 30 is not available. Therefore, the overall number of participants analyzed in Arm I (ZBEAM) is 1.|||Participants|||Count of Participants
2583580|NCT02366663|Secondary|Time to Progression|Time-to-event will be measured from the date of ASCT.|Up to 5 years|The study was terminated before the data are mature enough to estimate the cumulative incidence and conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.||||||
2583581|NCT02366663|Secondary|Progression-free Survival|Survival estimates will be calculated using the Kaplan-Meier method|Measured from randomization until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow up whichever comes first, for up to 5 years post randomization|The study was terminated before the data are mature enough to estimate the survival outcome and conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.||||||
2583582|NCT02366663|Primary|Overall Survival|Survival estimates will be calculated using the Kaplan-Meier method|Measured from randomization to date of death or last follow up date, whichever occurs first, for up to 5 years post randomization|The study was terminated before the data are mature enough to estimate the survival outcome and conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.||||||
2583583|NCT02366637|Other Pre-specified|Number of Participants With Laboratory Abnormalities|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, direct and indirect bilirubin, gamma-glutamyl transpeptidase [GGT], alkaline phosphatase, uric acid, albumin, total protein, high sensitivity C-reactive protein [CRP]); urinalysis (specific gravity, pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [only if urine dipstick was positive for blood or protein]).|Baseline up to Week 4|The mITT analysis set included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
2583584|NCT02366637|Other Pre-specified|Change From Baseline in Pulse Rate|Pulse rate was evaluated in the supine position.|Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.|||beats per minute (bpm)||Standard Deviation|Mean
2583585|NCT02366637|Other Pre-specified|Change From Baseline in Systolic and Diastolic Blood Pressure|Systolic blood pressure (SBP) and diastolic pressure (DBP) were evaluated in the supine position.|Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2583586|NCT02366637|Other Pre-specified|Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings|Clinically significant ECG findings include: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to 200 msec; QRS interval >=200 msec or >=25/50% increase from baseline; QT interval >=500 msec; corrected QT interval using Fridericia's formula (QTcF) >=450 msec or >=30 msec increase.|Baseline up to Day 29 (Week 4)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
2583587|NCT02366637|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 29 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to Day 29 (Week 4)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
2583588|NCT02366637|Secondary|Trough Plasma Concentration (Ctrough) of PF-03715455|Ctrough is the concentration prior to study drug administration.|Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29|As PK was not a primary objective of the study, only sparse PK sampling was performed to allow for a population PK analysis. As the study was prematurely terminated, there were too few subjects to perform this analysis. Therefore, the PK was not analyzed.||||||
2583589|NCT02366637|Secondary|Maximum Observed Plasma Concentrations (Cmax) of PF-03715455||Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29|As pharmacokinetics (PK) was not a primary objective of the study, only sparse PK sampling was performed to allow for a population PK analysis. As the study was prematurely terminated, there were too few subjects to perform this analysis. Therefore, the PK was not analyzed.||||||
2583590|NCT02366637|Secondary|Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Change over 4 weeks is presented.|Baseline, Week 1 to Week 4|The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.|||liters||Standard Deviation|Mean
2583591|NCT02366637|Secondary|Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 Baseline and Change at Week 4 are already reported under Primary Outcome Measure 1.|Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4)|The mITT analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.|||liters||Standard Deviation|Mean
2583592|NCT02366637|Secondary|Change From Baseline in Sputum Cell Counts Over 4 Weeks|Sputum cell counts included total neutrophils counts and differential (percent [%]), total cell count, total macrophage count and differential (%). Change over 4 weeks was to be presented.|Baseline, Week 1 to Week 4|It was not meaningful to summarize sputum cell counts as there were too few participants in the sputum sub-study and, of those, too few adequate sputum specimens to be meaningfully summarized.||||||
2583593|NCT02366637|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.|Baseline (Day 1), Day 29 (Week 4)|The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of study drug; n=number of participants analyzed in respective arms for category.|||liters||Standard Deviation|Mean
2583594|NCT02366468|Secondary|Number of Participants With Change in Diabetic Retinopathy Study (DRS) Retinopathy Scale|Evaluated by central reading center scoring fundus photography|Baseline to Month 12|FAS - LOCF - including only patients with assessments|||Participants|||Count of Participants
2583595|NCT02366468|Secondary|Mean Change of Foveal Center Point Thickness|Evaluated by central reading center assessing OCT images|Baseline to Month 12|FAS - LOCF - including only patients with assessments|||μm||Standard Deviation|Mean
2583597|NCT02366468|Secondary|Number of Treatment Free Intervals|A treatment-free interval is the interval between the first NO treatment given when the reason for NO treatment given is one of the three stability criteria and the first subsequent YES treatment given after that.|Baseline to Month 12|FAS - including only patients with at least one treatment-free interval|||Intervals||Standard Deviation|Mean
2583598|NCT02366468|Secondary|Number of Injections|mean number of injections in the study eye during the study|Baseline to Month 12|FAS|||Injections||Standard Deviation|Mean
2583599|NCT02366468|Secondary|Number of Visits|Mean number of visits during the study|Baseline to Month 12|FAS|||Visits||Standard Deviation|Mean
2583600|NCT02366468|Primary|Mean Average Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye From Month 1 to Study Treatment Completion (Month 12)|BCVA was assessed as letters read using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The mean average change from baseline was defined as the difference between the average level of BCVA (ETDRS letters) over all post-baseline assessments from Month 1 to Month 12. A positive change represents an improvement in visual acuity|Baseline, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12|FAS - Last Observation Carried Forward (LOCF)|||Letters||Standard Deviation|Mean
2583601|NCT02366338|Primary|Number of Patients With at Least One Inappropriate MAI Criterion|Appropriateness of oral anticoagulants was evaluated by adapted versions of the MAI|1 day||||participants|||Number
2583602|NCT02366195|Secondary|Number of Participants With Adverse Events|The severity of each adverse event (AE) was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 grading scale, where Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE Treatment-related adverse events (TRAE) were those assessed by the investigator as possibly related to talimogene laherparepvec.|From first dose through 30 days after last dose of talimogene laherparepvec; median duration of treatment was 25 (range 0.1 - 84) weeks.|Participants who received at least 1 dose of talimogene laherparepvec.|||Participants|||Count of Participants
2583603|NCT02366195|Secondary|Change From Baseline in Tumor Burden|"Tumor burden is the sum of the products of the 2 largest perpendicular diameters (SPD) for all index lesions selected at baseline.~Change from baseline in tumor burden was assessed in participants with an objective response."|Baseline and cycle 6 day 1, cycle 12 day 1, cycle 18 day 1, and cycle 24 day 1. The first cycles was 21 days and all subsequent cycles were 14 days.|Participants who received at least 1 dose of talimogene laherparepvec with an objective response (CR or PR).|||mm²||Standard Deviation|Mean
2583604|NCT02366195|Secondary|Overall Survival|"Overall survival (OS) was defined as the time from the date of first dose to the date of death from any cause.~OS time was censored at the last date the participant was known to be alive when the confirmation of death is absent or unknown."|From first dose of study drug until the data cut-off date of 26 June 2017; median time on follow-up was 59 weeks (range 3 to 116 weeks).|Participants who received at least 1 dose of talimogene laherparepvec.|||months||95% Confidence Interval|Median
2583605|NCT02366195|Secondary|Durable Response Rate|Durable response rate (DRR) was defined as the percentage of participants with an objective response (CR or PR) based on modified WHO response criteria lasting continuously for 6 months and starting any time within 12 months of initiating therapy.|Response was assessed every 12 weeks until PD beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up at the time of the data cut-off date (26 June 2017) was 59 weeks (range 3 to 116 weeks).|Participants who received at least 1 dose of talimogene laherparepvec.|||percentage of participants||95% Confidence Interval|Number
2583606|NCT02366195|Secondary|Time to Treatment Failure|Time to treatment failure (TTF) was calculated from first dosing until one or more of the following: (1) clinically relevant disease progression (PDr); (2) death from any cause; (3) non clinically relevant disease progression (PDn) associated with a requirement for alternative therapy as the reason for ending treatment or start of new anti-cancer therapy. Participants with no event were censored at their last evaluable tumor assessment.|From first dose of study drug until the data cut-off date of 26 June 2017; median time on follow-up was 59 weeks (range 3 to 116 weeks).|Participants who received at least 1 dose of talimogene laherparepvec.|||months||95% Confidence Interval|Median
2583607|NCT02366195|Secondary|Duration of Response|"Duration of response (DOR) was defined as the longest individual period from entering an objective response (CR/PR) to the first documented evidence of the participant no longer meeting the criteria for objective response (i.e. an overall response of either stable disease [SD] as compared with baseline or progressive disease [PD]).~SD: Neither sufficient tumor shrinkage of index lesion to qualify for response (PR or CR) nor sufficient tumor increase of index lesion to qualify for PD, with no increase in size of non-index lesions.~PD: A > 25% increase in the sum of the SPD of all index tumors since baseline, or the unequivocal appearance of a new tumor since the last response assessment time point, or unequivocal progression of one or more non-index lesions.~Participants last reported to be either a CR or PR were censored at that time point."|Response was assessed every 12 weeks until PD beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up at the time of the data cut-off date (26 June 2017) was 59 weeks (range 3 to 116 weeks).|Participants who received at least 1 dose of talimogene laherparepvec with an objective response.|||months||95% Confidence Interval|Median
2583608|NCT02366195|Secondary|Objective Response Rate|"Objective Response rate is defined as the percentage of participants with either a complete response (CR) or partial response (PR) based on Modified WHO Response Criteria.~CR: Complete disappearance of all index lesions, all non-index lesions, and any new tumors which might have appeared. Any residual cutaneous or subcutaneous index lesions must be documented by representative biopsy to not contain viable tumor.~PR: Disappearance of all index lesions with persistence of one or more non-index tumor(s), or, 50% or greater reduction in the SPD of all index lesions as compared to baseline, and disappearance or persistence of non-index lesions."|Response was assessed every 12 weeks until PD beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up at the time of the data cut-off date (26 June 2017) was 59 weeks (range 3 to 116 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.|||percentage of participants||95% Confidence Interval|Number
2583654|NCT02365519|Secondary|Percentage of Subjects With Anti-LME636 Antibodies by Visit|Samples were collected and assessed for anti-LME636 antibodies.|Day 15, Day 29, Day 43, Day 57, Day 71, Day 85|This analysis population includes all subjects with available immunogenicity data (Immunogenicity Analysis Set).|||percentage of subjects|||Number
2583609|NCT02366195|Secondary|Correlation Between Change From Baseline in Intratumoral CD8+ Cell Density and Changes in Tumor Burden|"Pearson's correlation coefficient (r) was estimated to assess the relationship between change from baseline in log2(CD8+ cell density) in uninjected lesions and the maximum decrease in measurable tumor burden.~Tumor burden is the sum of the products of the 2 largest perpendicular diameters (SPD) for all index lesions selected at baseline.~The Pearson's correlation coefficient (r) of log2(change from baseline intratumoral CD8+ cell density) and the maximum decrease in tumor burden is reported."|Intratumoral CD8+ cell density was assessed at baseline and week 6. Tumor burden was assessed every 12 weeks until PD beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up was 59 (range 3 - 116) weeks.|Participants who received at least 1 dose of talimogene laherparepvec with available tumor burden data and baseline and week 6 CD8+ cell density data for uninjected lesions.|||Pearson’s correlation coefficient||95% Confidence Interval|Number
2583610|NCT02366195|Secondary|Correlation Between Change From Baseline in Intratumoral CD8+ Cell Density and Duration of Response|"A Cox proportional hazards regression model was performed to evaluate change from baseline in log2(CD8+ cell density) as a predictor of duration of response.~Response was assessed according to the modified version of the World Health Organization (WHO) response criteria. Duration of response (DOR) is defined as the longest individual period from entering an objective response (CR/PR) to the first documented evidence of the participant no longer meeting the criteria for being in the response (i.e. an overall response of either stable disease [SD] as compared with baseline or progressive disease [PD]).~The unadjusted hazard ratio of log2(change from baseline intratumoral CD8+ cell density) for duration of response is reported."|Intratumoral CD8+ cell density was assessed at Baseline and week 6. Response was assessed every 12 weeks until PD beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up was 59 weeks (range 3 - 116 weeks).|Participants who received at least 1 dose of talimogene laherparepvec with an objective response and with baseline and week 6 CD8+ cell density data for uninjected lesions.|||ratio||95% Confidence Interval|Number
2583611|NCT02366195|Secondary|Correlation Between Change From Baseline in Intratumoral CD8+ Cell Density and Durable Response Rate|"A univariate logistic regression model was performed to evaluate change from baseline to week 6 in log2(CD8+ cell density) in uninjected lesions as a predictor of durable response.~Response was assessed according to the modified version of the World Health Organization (WHO) response criteria. Durable response rate (DRR) was defined as the percentage of participants with an objective response lasting continuously for 6 months and starting any time within 12 months of initiating therapy.~The unadjusted odds ratio of log2(change from baseline in intratumoral CD8+ cell density) for durable response rate is reported."|Intratumoral CD8+ cell density was assessed at Baseline and week 6. Response was assessed every 12 weeks until PD beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up was 59 weeks (range 3 - 116 weeks).|Participants who received at least 1 dose of talimogene laherparepvec with baseline and week 6 CD8+ cell density data in uninjected lesions.|||ratio||95% Confidence Interval|Number
2583612|NCT02366195|Secondary|Correlation Between Change From Baseline Intratumoral CD8+ Cell Density and Objective Response Rate|"A univariate logistic regression model was performed to evaluate change from baseline to week 6 in log2(CD8+ cell density) in uninjected tumors as a predictor of objective response.~Response was assessed according to the modified version of the World Health Organization (WHO) response criteria. Objective response rate (ORR) was defined as the percentage of participants with a complete response or partial response according to the modified WHO criteria.~The unadjusted odds ratio of log2(change from baseline intratumoral CD8+ cell density) for objective response rate is reported."|Intratumoral CD8+ cell density was assessed at Baseline and week 6. Response was assessed every 12 weeks until PD beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up was 59 weeks (range 3 - 116 weeks).|Participants who received at least 1 dose of talimogene laherparepvec with baseline and week 6 CD8+ cell density data for uninjected lesions.|||ratio||95% Confidence Interval|Number
2583613|NCT02366195|Secondary|Correlation Between Baseline Intratumoral CD8+ Cell Density and Changes in Tumor Burden|"Pearson's correlation coefficient (r) was estimated to assess the relationship between baseline log2(CD8+ cell density) and the maximum decrease in measurable tumor burden.~Tumor burden is the sum of the products of the 2 largest perpendicular diameters (SPD) for all index lesions selected at baseline.~The Pearson's correlation coefficient (r) of log2(baseline intratumoral CD8+ cell density) and the maximum decrease in tumor burden is reported."|Intratumoral CD8+ cell density was assessed at baseline. Disease burden was assessed every 12 weeks until disease progression beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up was 59 (range 3 - 116) weeks.|Participants who received at least 1 dose of talimogene laherparepvec with available tumor burden data and baseline CD8+ cell density data.|||Pearson’s correlation coefficient||95% Confidence Interval|Number
2583614|NCT02366195|Secondary|Correlation Between Baseline Intratumoral CD8+ Cell Density and Duration of Response|"A Cox proportional hazards regression model was performed to evaluate baseline log2(CD8+ cell density) as a predictor of duration of response.~Response was assessed according to the modified version of the World Health Organization (WHO) response criteria. Duration of response (DOR) is defined as the longest individual period from entering an objective response (CR/PR) to the first documented evidence of the participant no longer meeting the criteria for being in the response (i.e. an overall response of either stable disease [SD] as compared with baseline or progressive disease [PD]).~The unadjusted hazard ratio of log2(baseline intratumoral CD8+ cell density) for duration of response is reported."|Intratumoral CD8+ cell density was assessed at Baseline. Response was assessed every 12 weeks until disease progression beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up was 59 weeks (range 3 - 116 weeks).|Participants who received at least 1 dose of talimogene laherparepvec with an objective response and with baseline CD8+ cell density data.|||ratio||95% Confidence Interval|Number
2583655|NCT02365519|Secondary|Percentage of Subjects With LME636 Serum Concentrations Below the Lower Limit of Quantification (LLOQ)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. LLOQ is defined as 0.25 ng/mL.|Day 15, Day 29, Day 43, Day 57, Day 71, Day 85|This analysis population includes all subjects with available pharmacokinetics data (Pharmacokinetics Analysis Set).|||percentage of subjects|||Number
2583914|NCT02361736|Secondary|Estimated Glomerular Filtration Rate(eGFR) on 5 Time Point|eGFR is calculated by concentration of creatinine and CKD-EPI2009|-1d, 0d, 1d, 3d, 5d after surgery||||mL/min/1.73m2||Standard Deviation|Mean
2583615|NCT02366195|Secondary|Correlation Between Baseline Intratumoral CD8+ Cell Density and Durable Response Rate|"A univariate logistic regression model was performed to evaluate baseline log2(CD8+ cell density) as a predictor of durable response.~Response was assessed according to the modified version of the World Health Organization (WHO) response criteria. Durable response rate (DRR) was defined as the percentage of participants with an objective response lasting continuously for 6 months and starting any time within 12 months of initiating therapy.~The unadjusted odds ratio of log2(baseline intratumoral CD8+ cell density) for durable response rate is reported."|Intratumoral CD8+ cell density was assessed at Baseline. Response was assessed every 12 weeks until disease progression beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up was 59 weeks (range 3 - 116 weeks).|Participants who received at least 1 dose of talimogene laherparepvec with baseline CD8+ cell density data.|||ratio||95% Confidence Interval|Number
2583616|NCT02366195|Primary|Correlation Between Baseline Intratumoral CD8+ Cell Density and Objective Response Rate|"A univariate logistic regression model was performed to evaluate baseline log2(CD8+ cell density) as a predictor of objective response.~Response was assessed according to the modified version of the World Health Organization (WHO) response criteria. Objective response rate (ORR) was defined as the percentage of participants with a complete response or partial response according to the modified WHO criteria.~The unadjusted odds ratio of log2(baseline intratumoral CD8+ cell density) for objective response rate is reported."|Intratumoral CD8+ cell density was assessed at Baseline. Response was assessed every 12 weeks until disease progression beyond 6 months of treatment or the start of new anticancer therapy; median time on follow-up was 59 weeks (range 3 - 116 weeks).|Participants who received at least 1 dose of talimogene laherparepvec with baseline CD8+ cell density data.|||ratio||95% Confidence Interval|Number
2583617|NCT02365961|Other Pre-specified|Hospital Readmission|Number of participants that were readmitted to the hospital|3 months||||Participants|||Count of Participants
2583618|NCT02365961|Other Pre-specified|Total Number of Episodes of Nausea and Vomiting|Occurrences of periods of nausea and vomiting|From end of surgery to discharge from PACU||||Number of episodes|||Number
2583619|NCT02365961|Other Pre-specified|Time in PACU|Measured time subjects spent in the post anesthesia care unit.|Duration of PACU stay in minutes from end of surgery to discharge from PACA||||Minutes||95% Confidence Interval|Mean
2583620|NCT02365961|Secondary|Opioid Consumption|Opioid consumption, as measured by narcotic usage (morphine milligram equivalents)|3 Months||||morphine milligram equivalents||95% Confidence Interval|Mean
2583621|NCT02365961|Primary|Visual Analog Scale|Pain, as measured by Visual Analog Scale (VAS). Scores are ranged from 0-10, 0 is no pain and 10 is worst possible pain. The unit of measure is units on a scale.|3 Months||||units on a scale||95% Confidence Interval|Mean
2583622|NCT02365870|Secondary|Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale|"The main outcome measure for this study was change in depression symptom severity over the course of the study. Depression severity was measured using the Hamilton Depression Rating Scale (HAMD). The HAMD is a 17-item questionnaire, with each item assigned a score ranging from 0 (not present) to 4 (severe). The total score of this scale ranges from 0 to 68, with scores greater than 7 indicating mild depressive symptoms."|Baseline, weeks 2, 4 and 8||||score on a scale||Standard Deviation|Mean
2583623|NCT02365870|Primary|Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale|"The main outcome measure for this study was change in anxiety symptom severity over the course of the study. Anxiety severity was measured using the Hamilton Anxiety Rating Scale (HARS).The HARS is a 14-item questionnaire, with each item assigned a score ranging from 0 (not present) to 4 (severe). The total score of this scale ranges from 0 to 56, with scores greater than 17 indicating mild severity, scores between 18 and 24 indicating mild to moderate severity and scores greater than 25 indicating moderate to severe severity."|Baseline, weeks 2, 4 and 8||||score on a scale||Standard Deviation|Mean
2583624|NCT02365714|Secondary|Ipsilateral Breast Recurrence|No patients have recurred to date.|1 month post radiation treatment through 5 years post treatment||||Participants|||Count of Participants
2583625|NCT02365714|Primary|Feasibility|How many patients were able to undergo CK SAPBI|2 years||||Participants|||Count of Participants
2583626|NCT02365714|Primary|The Primary Endpoint for This Study is the Percentage of Enrolled Subjects in Whom CyberKnife SAPBI PBI is Technically Feasible to Deliver and Complete Treatment|Only one of two patients were able to undergo CyberKnife SAPBI. We are measuring the percentage of enrolled subjects in whom CyberKnife SAPBI PBI is technically feasible to deliver and complete treatment|Enrollment to 24 months||||Participants|||Count of Participants
2583627|NCT02365688|Primary|Dynamic Hemodynamic Response to Fluid Resuscitation|Physiological parameters compared before and after fluid bolus for fluid resuscitation.|Up to 6 hours but not to exceed duration of surgical procedure|Reference devices were in disagreement so the algorithm could not be verified||||||
2583628|NCT02365636|Secondary|Participants With Treatment-Emergent Adverse Events|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|day 1 up to day 57|Safety population|||Participants|||Count of Participants
2583644|NCT02365584|Secondary|Number of Patients Experiencing ≤ 2 Vomiting Episodes/Day During at Least 3 Consecutive Days, in Patients Without NGT|Vomiting episodes and NGT presence were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability. Number of patients experiencing ≤ 2 vomiting episodes/day during at least 3 consecutive days, in patients without NGT, is presented.|From Baseline (Day 1, before randomisation) to Days 7, 14 and 28.|Patients without NGT were defined as patients without the insertion of NGT for the whole study period. Only patients in the ITT population without NGT and with data available for analysis at each time point are presented.|||Participants|||Count of Participants
2583629|NCT02365636|Secondary|Change From Baseline to Weeks 2 and 4 in Maximal Intensity of Punctate-Evoked Hyperalgesia as Measured on an 11-point Numeric Rating Scale (NRS) Using a Mixed Model for Repeated Measures (MMRM)|"Hyperalgesia refers to increased pain from a stimulus that normally provokes pain. In this case, pain is evoked by punctate skin stimulation using a Medipin® and is measured on an 11-point NRS where 0=no pain and 11=worst pain imaginable as reported by patients. Negative change from baseline scores indicate improvement (lessening) of pain.~The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor. The unstructured covariance matrix for repeated observations within patients was used."|Baseline (day 1 prior to dosing), Weeks 2 (day 15) and Week 4 (day 29)|Full analysis set. Participants from one site are excluded due to lack of data integrity. Participants from two other sites are excluded since the two sites incorrectly assessed allodynia. If punctate-evoked hyperalgesia was not present at screening, it was not rechecked on subsequent visits.|||units on a scale||Standard Deviation|Mean
2583630|NCT02365636|Secondary|Change From Baseline to Weeks 2 and 4 in Maximal Intensity of Brush-Evoked Allodynia as Measured on an 11-point Numeric Rating Scale (NRS) Using a Mixed Model for Repeated Measures (MMRM)|Allodynia refers to central pain sensitization (increased response of neurons) following normally non-painful, often repetitive, stimulation. In this case, pain evoked by innocuous brush is measured on an 11-point NRS where 0=no pain and 11=worst pain imaginable as reported by patients Negative change from baseline scores indicate improvement (lessening) of pain.|Baseline (day 1 prior to dosing), Weeks 2 (day 15) and Week 4 (day 29)|Full analysis set. Participants from one site are excluded due to lack of data integrity. Participants from two other sites are excluded dince the two sites incorrectly assessed allodynia. If brush-evoked allodynia was not present at screening, it was not rechecked on subsequent visits.|||units on a scale||Standard Deviation|Mean
2583631|NCT02365636|Secondary|Kaplan-Meier Estimates for First Time to Reach 30% or More Sustained Improvement in Weekly Average of the Daily Average NRS Pain Scores|Percent improvement is calculated as 100*(the weekly average of the daily average NRS pain score - weekly average of the daily average NRS pain scores at baseline [days -7 to -1])/weekly average of the daily average NRS pain scores at baseline. Patients who do not reach >= 30% improvement are censored at their last non-missing weekly average. Patients who reach >= 30% improvement, but the improvement is not sustained through the end of the treatment period are censored at their last non-missing weekly average. For patients who reach >= 30% improvement that is sustained through the end through the end of the of the treatment, the time >= 30% improvement is first reached is used.|Baseline (days -7 to -1), Week 1 (days 1-7), Week 2 (day 8-14), Week 3 (days 15-21), Week 4 (days 22-29)|Full analysis set. Participants from one site are excluded due to lack of data integrity.|||days||95% Confidence Interval|Median
2583632|NCT02365636|Secondary|Change From Baseline to Weeks 2 and 4 in the Daily Sleep Interference Scale (DSIS) Using a Mixed Model for Repeated Measures|"DSIS is an 11-point scale that asks the patient to select the number that best describes how much your pain has interfered with your sleep during the past 24 hours. Response options range from 0 (Did not interfere with sleep) to 10 (Completely interfered with sleep/unable to sleep due to pain). Negative change from baseline scores indicate improvement (lessening) of how much pain interfered with sleep.~The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor."|Baseline (day 1 prior to dosing), Weeks 2 (day 15) and Week 4 (day 29)|Full analysis set. Participants from one site are excluded due to lack of data integrity. Data collected beyond last dose of study medication plus 3 days are excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2583633|NCT02365636|Secondary|Participants' Global Assess of Treatment as Measured by the Patient Global Impression of Change (PGIC) at Weeks 2 and 4 Using a Mixed Model for Repeated Measures (MMRM)|"PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of treatment on 7-point scale (Hurst and Bolton 2004). The 7-point scale is defined as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.~The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor."|Weeks 2 (day 15) and Week 4 (day 29)|Full analysis set. Participants from one site are excluded due to lack of data integrity. Data collected beyond last dose of study medication plus 3 days are excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2583634|NCT02365636|Secondary|Change From Baseline to Week 4 in the Neuropathic Pain Impact on Quality of Life (NePIQoL) Total Score|NePIQoL is a questionnaire that contains 41 items to evaluate quality of life in patients with neuropathic pain. Each question has responses ranging from strongly agree or always to strongly disagree or never. Questions are scored on a 5-point scale from 1 through 5, where higher scores represent greater pain-related interference in quality of life. Total range is 41 (great quality of life) to 205 (worst quality of life). Negative change from baseline scores indicated an improving quality of life.|Baseline (day 1), Week 4 (day 29)|Full analysis set. Participants from one site are excluded due to lack of data integrity.|||units on a scale||Standard Deviation|Mean
2583635|NCT02365636|Secondary|Change From Baseline to Weeks 2 and 4 in the Neuropathic Pain Symptom Inventory (NPSI) Total Score Using a Mixed Model for Repeated Measures (MMRM)|"NPSI is a patient-reported questionnaire to evaluate the severity of different symptoms of neuropathic pain. The questionnaire contains 10 descriptors representing 5 distinct dimensions of pain: burning pain, deep pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia, plus 2 temporal items. Descriptors are scored from 0 through 10, where higher scores represent worse pain. The total score is the sum of the scores of the 10 descriptors (Bouhassira et al 2004). The total score ranges from 0 (no pain) through 100 (worst pain imaginable). If the score for one question was missing the total score was computed as 10 times sum of scores of 9 descriptors divided by 9. If more than one question was missing then the total score was missing. Negative change from baseline scores indicated less pain.~The MMRM used pooled study center, week, treatment, and treatment by week interaction as fixed factors and patient as a random factor."|Baseline (day 1 prior to dosing), Weeks 2 (day 15) and Week 4 (day 29)|Full analysis set. Participants from one site are excluded due to lack of data integrity.|||units on a scale||Standard Deviation|Mean
2583653|NCT02365558|Primary|Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib||Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8,12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose|All participants who received at least one dose of study drug.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2583636|NCT02365636|Secondary|Percentage of Participants With >=30% and >=50% Improvement From Baseline in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores at Week 4 Using a Mixed Model for Repeated Measures|The NRS is a 11-point scale from 0=no pain to 10=worst pain imaginable as reported by patients. The daily average NRS scores is the average of the 2 NRS scores (recorded in the morning and evening) of average pain, defined as the patient-reported average pain intensity over the prior 12 hours. Percent improvement is calculated as 100 × (the weekly average of the daily average NRS pain score at week 4 - weekly average of the daily average NRS pain scores at baseline /weekly average of the daily average NRS pain scores at baseline. Patients missing a week 4 average are considered non-responders (<50% improvement or <30% improvement). The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the daily average NRS scores as covariate; and patient as a random effect.|Baseline (day -7 to day -1), Week 4 (day 22 to day 28)|Full analysis set. Participants from one site are excluded due to lack of data integrity.|||percentage of participants|||Number
2583637|NCT02365636|Secondary|Change From Baseline to Week 4 in the Weekly Average of the Worst Numeric Rating Scale (NRS) Pain Scores Recorded in the Evening Using a Mixed Model for Repeated Measures|The NRS is a widely-used, standard one-dimensional 11-point scale from 0=no pain to 10=worst pain imaginable as reported by patients. The worst pain is defined as the patient-reported worst pain intensity over the prior 24 hours. Negative change from baseline values indicate a lessening of pain. The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the worst pain NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the evening NRS scores as covariate; and patient as a random effect.|Baseline (day -7 to day -1), Week 4 (day 22 to day 28)|Full analysis set. Participants from one site are excluded due to lack of data integrity.|||units on a scale||Standard Deviation|Mean
2583638|NCT02365636|Secondary|Change From Baseline to Week 4 in the Weekly Average of the Average Numeric Rating Scale (NRS) Pain Scores Recorded in the Morning Using a Mixed Model for Repeated Measures|The NRS is a widely-used, standard one-dimensional 11-point scale from 0=no pain to 10=worst pain imaginable as reported by patients. The NRS pain scores recorded in the morning is defined as the patient-reported average pain intensity over the prior 12 hours. Negative change from baseline values indicate a lessening of pain. The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the evening NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of morning NRS scores as covariate; and patient as a random effect.|Baseline (day -7 to day -1), Week 4 (day 22 to day 28)|Full analysis set. Participants from one site are excluded due to lack of data integrity.|||units on a scale||Standard Deviation|Mean
2583639|NCT02365636|Secondary|Change From Baseline to Week 4 in the Weekly Average of the Average Numeric Rating Scale (NRS) Pain Scores Recorded in the Evening Using a Mixed Model for Repeated Measures|The NRS is a widely-used, standard one-dimensional 11-point scale from 0=no pain to 10=worst pain imaginable as reported by patients. The NRS pain scores recorded in the evening is defined as the patient-reported average pain intensity over the prior 12 hours. Negative change from baseline values indicate a lessening of pain. The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the evening NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the evening NRS scores as covariate; and patient as a random effect.|Baseline (day -7 to day -1), Week 4 (day 22 to day 28)|Full analysis set. Participants from one site are excluded due to lack of data integrity.|||units on a scale||Standard Deviation|Mean
2583640|NCT02365636|Primary|Change From Baseline to Week 4 in the Weekly Average of the Daily Average Numeric Rating Scale (NRS) Pain Scores Using a Mixed Model for Repeated Measures|The primary efficacy endpoint was the change from baseline to week 4 in the weekly average of the daily average NRS scores. The NRS is a widely-used, standard one-dimensional 11-point scale from 0=no pain to 10=worst pain imaginable as reported by patients. The daily average NRS scores is the average of the 2 NRS scores (recorded in the morning and evening) of average pain, defined as the patient-reported average pain intensity over the prior 12 hours. At least 1 of the 2 daily scores had to be recorded (non-missing) or the daily average was considered missing. Negative change from baseline values indicate a lessening of pain. The Mixed Model Repeated Measures (MMRM) model with change from baseline in the weekly average of the daily average NRS scores at week 4 as the dependent variable; week, pooled study center, treatment, and treatment by visit interaction as fixed factors, baseline weekly average of the daily average NRS scores as covariate; and patient as a random effect.|Baseline (day -7 to day -1), Week 4 (day 22 to day 28)|Full analysis set; patients from one site are excluded due to lack of data integrity.|||units on a scale||Standard Deviation|Mean
2583641|NCT02365584|Secondary|Assessment of Passage of Stools; ITT Population|Passage of stools assessments (Yes/No) were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability.|From Baseline (Day 1, before randomisation) to Day 28.|The ITT population included all randomised patients. Only patients with data available for analysis at each time point are presented.|||Participants|||Count of Participants
2583642|NCT02365584|Secondary|Mean Change From Baseline in Number of Daily Vomiting Episodes; ITT Population|Vomiting episodes were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability. Mean change from baseline in number of daily vomiting episodes is presented for the ITT population.|Baseline (Day 1, before randomisation) and Days 7, 14 and 28.|The ITT population included all randomised patients. Only patients with data available at each time point are presented.|||Episodes (daily)||Standard Deviation|Mean
2583643|NCT02365584|Secondary|Mean Daily NGT Secretion Volume, in Patients With a NGT|NGT presence and related secretion volume were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability. Mean daily secretion volumes, in patients with NGT, is presented.|Baseline (Day 1, before randomisation) and Days 7, 14 and 28.|Only patients with NGT and with data available for analysis at each time point are presented.|||millilitres||Standard Deviation|Mean
2583915|NCT02361736|Secondary|Concentration of β2 Microglobulin in Urine||-1d, 0d, 1d, 3d, 5d after surgery||||mg/L||Standard Deviation|Mean
2583645|NCT02365584|Secondary|Mean Change From Baseline in Daily Intensity of Abdominal Pain Score (Visual Analogue Scale [VAS]); ITT Population|"Abdominal pain was assessed using the VAS numeric pain distress scale which is a 100-millimetre (10-centimetre) scoring scale on which patients mark their perceived level of pain. Scores range from 0 to 100 where 0=no pain and 100=unbearable pain. Higher scores indicate a worse outcome. Scores were recorded on the Patient Diary daily until the end of study (Day 28), by the patient or filled in by the nurse/caregiver in case of patient's physical inability.~Mean change from baseline of VAS for abdominal pain at Days 7, 14 and 28 is presented for the ITT population; a positive change indicates a worsening condition."|Baseline (Day 1, before randomisation) and Days 7, 14 and 28.|The ITT population included all randomised patients. Only patients with data available for analysis at each time point are presented.|||Scores on a scale||Standard Deviation|Mean
2583646|NCT02365584|Secondary|Mean Change From Baseline in Performing General Activity (Karnofsky Performance Status [KPS]); ITT Population|"The KPS allows patients to be classified as to their functional impairment and was used to assess general activity. KPS scores range from 0 (dead) to 100 (normal/no disease) and are classified as 0-40 = unable to care for self; 50-70 = unable to work; 80-100 = able to work. The lower the KPS score, the worse the survival for most serious illnesses. Scores were recorded on the patient's medical file at each study visit (Days 1, 7, 14 and 28).~Mean change from baseline of KPS score at Days 7, 14 and 28 is presented for the ITT population (all randomised patients); a negative change indicates a worsening condition."|Baseline (Day 1, before randomisation) and Days 7, 14 and 28.|The ITT population included all randomised patients. Only patients with data available for analysis at each time point are presented.|||Scores on a scale||Standard Deviation|Mean
2583647|NCT02365584|Secondary|Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population|"Quality of Life was assessed using ESAS, evaluating 9 common symptoms in cancer patients: pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. Symptom severity is rated 0-10 on a numerical scale (0=symptom absent; 10=worst severity). Low scores indicate good quality of life; high scores indicate strong discomfort. Questionnaire assessments by the patient or by nurse/caregiver in case of patient's physical inability.~Mean change from baseline of each individual ESAS item score at Days 7, 14 and 28 is presented; a positive change indicates a worsening condition."|Baseline (Day 1, before randomisation) and Days 7, 14 and 28.|The ITT population included all randomised patients. Only patients with data available for analysis at each time point are presented.|||Scores on a scale||Standard Deviation|Mean
2583648|NCT02365584|Secondary|Mean Change From Baseline in ESAS Total Score; ITT Population|"Quality of Life was assessed using ESAS, evaluating 9 common symptoms in cancer patients: pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. Symptom severity is rated 0-10 on a numerical scale (0=symptom absent; 10=worst severity). ESAS total score is sum of the 9 items (min score=0, max score=90). Low scores indicate good quality of life; high scores indicate strong discomfort. Questionnaire assessments by the patient or by nurse/caregiver in case of patient's physical inability.~Secondary endpoints were analysed using the ITT population but to permit following the FAS which was used for primary endpoint analysis, ESAS total score results are reported for both the ITT and the FAS. Mean change from baseline of ESAS total score at Days 7, 14 and 28 is presented here for the ITT population; a positive change indicates a worsening condition."|Baseline (Day 1, before randomisation) and Days 7, 14 and 28.|The ITT population included all randomised patients. Only patients with data available for analysis at each time point are presented.|||Scores on a scale||Standard Deviation|Mean
2583649|NCT02365584|Secondary|Mean Change From Baseline in ESAS Total Score; FAS|"Quality of Life was assessed using ESAS, evaluating 9 common symptoms in cancer patients: pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. Symptom severity is rated 0-10 on a numerical scale (0=symptom absent; 10=worst severity). ESAS total score is sum of the 9 items (min score=0, max score=90). Low scores indicate good quality of life; high scores indicate strong discomfort. Questionnaire assessments by the patient or by nurse/caregiver in case of patient's physical inability.~Secondary endpoints were analysed using the ITT population but to permit following the FAS which was used for primary endpoint analysis, ESAS total score results are reported for both the ITT and the FAS. Mean change from baseline of ESAS total score at Days 7, 14 and 28 is presented here for the FAS; a positive change indicates a worsening condition."|Baseline (Day 1, before randomisation) and Days 7, 14 and 28.|The FAS included all randomised patients who received study therapy, fulfilled the ESAS questionnaire at baseline and had ≥ 5 post-treatment assessments during the first 7 days of the study. Only patients with data available for analysis at each time point are presented.|||Scores on a scale||Standard Deviation|Mean
2583650|NCT02365584|Primary|Least Squares (LS) Mean Area Under Curve (AUC) of Edmonton Symptom Assessment System (ESAS) Total Scores Collected for the First 7 Days; Full Analysis Set (FAS)|"Quality of Life was assessed using ESAS, evaluating 9 common symptoms in cancer patients: pain, activity, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. Symptom severity is rated 0-10 on a numerical scale (0=symptom absent; 10=worst severity). ESAS total score is sum of the 9 items (min score=0, max score=90). Low scores indicate good quality of life; high scores indicate strong discomfort. Questionnaire assessments by the patient or by nurse/caregiver in case of patient's physical inability. AUC is area under the line which joins the points defined by plotting ESAS total score on vertical axis and time values on horizontal axis, computed using trapezoidal rule.~Primary endpoint was analysed using the FAS. LS mean AUC of ESAS total scores during first 7 days is presented."|Baseline (Day 1, before randomisation), Days 2, 3, 4, 5, 6 and 7.|The FAS included all randomised patients who received study therapy, fulfilled the ESAS questionnaire at baseline and had ≥ 5 post-treatment assessments during the first 7 days of the study.|||Scores on a scale x time (day)||Standard Error|Least Squares Mean
2583651|NCT02365558|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])||Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose|All participants who received at least one dose of study drug.|||nanogram*hour per milliliter (ng·h/mL)||Geometric Coefficient of Variation|Geometric Mean
2583652|NCT02365558|Primary|Pharmacokinetics (PK): Time of Maximum Observed Concentration (Tmax) of Evacetrapib||Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose|All participants who received at least one dose of study drug.|||Hours||Full Range|Median
2583916|NCT02361736|Primary|Concentration of IL-18 in Plasma on 5 Time Point||-1d, 0d, 1d, 3d, 5d after surgery||||μg/L||Standard Deviation|Mean
2583656|NCT02365519|Secondary|Percentage of Subjects With More Than 20 Units Improvement in Global Ocular Discomfort Score From Baseline at Day 71|Discomfort frequency and severity (each graded on a separate 100-units scale) were assessed daily using a VAS displayed on a handheld ePRO. Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past 24 hours' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past 24 hours' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for any given day, as the square root of the product of the discomfort frequency score multiplied by the discomfort severity score. Improvement results in a reduction of the discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline.|Baseline (Day 43), Day 71|Per-Protocol Set|||percentage of subjects|||Number
2583657|NCT02365519|Primary|Percentage of Subjects With Increase in Dilated Fundus Parameter From Baseline to Any Visit|The dilated fundus examination was performed to evaluate the health of the vitreous, retina, macula, choroid, and optic nerve. An increase indicates worsening. Only one eye contributed to the analysis.|Baseline (Day 43), Day 57, Day 71, Day 85|Safety Analysis Set|||percentage of subjects|||Number
2583658|NCT02365519|Primary|Percentage of Subjects With Increase in Slit-Lamp Parameter From Baseline to Any Visit|Ocular signs (cornea, lens, and iris/anterior chamber) were assessed by slit-lamp biomicroscopy. An increase indicates worsening. Only one eye contributed to the analysis.|Baseline (Day 43), Day 57, Day 71, Day 85|Safety Analysis Set|||percentage of subjects|||Number
2583659|NCT02365519|Primary|Intraocular Pressure (IOP)|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry or Tonopen and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Both eyes contributed to the analysis.|Baseline (Day 43), Day 57, Day 71, Day 85|Safety Analysis Set. Number Analyzed is the number of subjects with data at visit.|||mmHg||Standard Deviation|Mean
2583660|NCT02365519|Primary|Best Corrected Visual Acuity (BCVA)|Visual Acuity (VA) with the subject's best spectacles or other visual corrective devices was measured using an ETDRS visual acuity chart at 3 meters (10 feet) and reported in letters read correctly. An increase (gain) in letters read indicates improvement. Both eyes contributed to the analysis.|Baseline (Day 43), Day 57, Day 71, Day 85|This analysis population includes all subjects that received any study drug (Safety Analysis Set). Number Analyzed is the number of subjects with data at visit.|||letters||Standard Deviation|Mean
2583661|NCT02365519|Primary|Mean Change From Baseline in Global Ocular Discomfort Score at Day 71|Discomfort frequency and severity (each graded on a separate 100-units scale) were assessed daily using a visual analog scale (VAS) displayed on a handheld digital Pad (electronic patient-reported outcome (ePRO)). Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past 24 hours' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past 24 hours' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for any given day, as the square root of the product of the discomfort frequency score multiplied by the discomfort severity score. Improvement results in a reduction of the discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline. A negative change from baseline indicates improvement.|Baseline (Day 43), Day 71|This analysis population includes all randomized subjects with at least a post-baseline primary endpoint assessment excluding all subjects who met the critical deviation criteria (Per-Protocol Set). Number Analyzed is the number of subjects with data at visit.|||units on a scale||Standard Error|Mean
2583662|NCT02365298|Primary|Quantity of Cytokines and Albumin in Tear Fluid|Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.|12 wks after baseline|All subjects that completed all study visits without a major protocol deviation. All 12 subjects completed the study, however in some subjects the concentration of cytokine levels were below detectable limits in the tear film sample and could not be analyzed.|||(pg/ml)||Standard Deviation|Mean
2583663|NCT02365298|Primary|Quantity of Cytokines and Albumin in Tear Fluid|Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha. Measurement will be taken after the subject has worn the lenses for a full seven hours. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.|6 wks after baseline|All subjects that completed all study visits without a major protocol deviation. All 12 subjects completed the study, however in some subjects the concentration of cytokine levels were below detectable limits in the tear film sample and could not be analyzed.|||(pg/ml)||Standard Deviation|Mean
2583664|NCT02365298|Primary|Quantity of Cytokines and Albumin in Tear Fluid|Measured cytokines: IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12, IL-13, and TNF-alpha Measurement will be taken after the subject has worn the lenses for a full seven hours.|2 wks after baseline|Subjects that completed all study visits without a major protocol deviation. All 24 subjects completed the study, however in some subjects the concentration of cytokine levels were below detectable limits in the tear film sample and could not be analyzed.|||(pg/ml)||Standard Deviation|Mean
2583665|NCT02365298|Primary|Total Protein and Lysosome Deposits|Measurement will be taken after the subject has worn the lenses for a full seven hours|12 wks after baseline|All subjects that completed all study visits without a major protocol deviation.During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.|||(ug/lens)||Standard Deviation|Mean
2583666|NCT02365298|Primary|Total Protein and Total Lysosome Deposits|Measurement will be taken after the subject has worn the lenses for a full seven hours|6 wks after baseline|Subjects that completed all study visits without a major protocol deviation. During the 2nd period subjects continued wearing the current lens that they were randomized to for an additional 6 weeks of wear.|||(ug/lens)||Standard Deviation|Mean
2583667|NCT02365298|Primary|Total Protein and Total Lysosome Deposits|Measurement will be taken after the subject has worn the lenses for a full seven hours|2 wks after baseline|All subjects that completed all study visits without a major protocol deviation.|||(ug/lens)||Standard Deviation|Mean
2583668|NCT02365285|Primary|Change in Oxidative Stress: Baseline to 4 Hours|Measure F-2 isoprostanes as a marker of oxidation|Baseline to 4 hours|1 white participant did not have 4 hour F-2 isoprostanes drawn after receiving placebo. 2 white participants dropped out due to nausea. 1 African-American was withdrawn, MD decision.|||pg/ml||Standard Deviation|Mean
2583669|NCT02365285|Primary|Change in Oxidative Stress: Baseline to 2 Hours|Measure F-2 isoprostanes as a marker of oxidation|Baseline to 2 hours|2 white participants dropped out due to nausea. 1 African-American was withdrawn, MD decision.|||pg /ml||Standard Deviation|Mean
2583670|NCT02365233|Primary|Change in Hepatic Lipid Content From Baseline Visit to Six Month Follow up Visit|Comparison of the hepatic lipid content measurement taken by MRI at baseline with the measurement taken by MRI at the 6 month follow up visit.|Hepatic lipid content measurement will be taken on Day #1 ( the day of randomization) and at the 6 month follow up visit.|IRB withheld the data due to inadequate supporting documentation||||||
2583671|NCT02365207|Primary|Ability of BCG to Enhance Tumor Specific Immunity|The tumor specific immunity is measured by the change in T cell proliferation post-treatment compared to the pre-treatment assessment, which will require a sample size of at least 10|At cystectomy at 3-6 weeks after BCG treatment|Data were not analyzed, since the study closed prematurely due to poor accrual and lack of funding. Since the change in T-cell proliferation required a sample size of at least 10 and only 4 subjects who were randomized completed. No data were analyzed for this study, since that sample size was not achieved.||||||
2583672|NCT02364999|Secondary|Number of Participants With Neutralizing Antibody (NAb)|Only samples that were confirmed positive for ADA were further tested for NAb. The NAb analysis was conducted using a single validated quasi-quantitative enzyme-linked immunosorbent assay (ELISA) that utilized PF-06439535 as a reagent. Samples with NAb titer >=1.70 were considered positive.|55 weeks|The analysis population included all participants who had positive ADA results at any time point.|||Participants|||Count of Participants
2583673|NCT02364999|Secondary|Number of Participants With Anti-Drug Antibody (ADA)|ADA assay was performed using a sensitive, specific, and semi-quantitative electrochemiluminescent (ECL) method, which used biotinylated- and ruthenium-labeled PF-06439535 as reagents. Samples with ADA titer greater than or equal to (>=) 2.29 were considered positive.|55 weeks|The analysis population included all participants who were randomized and received at least 1 dose of study treatment.|||Participants|||Count of Participants
2583674|NCT02364999|Secondary|Serum Concentration of Bevacizumab up to 1 Year||Pre-dose from Cycle 1 to Cycle 17, 2.5 hours post-dose in Cycle 1, and 1.5 hours post-dose in Cycle 5|The analysis population included all participants in the per-protocol population (all participants who were randomized and received study treatment as planned and had no major protocol deviations) who had at least 1 drug concentration measurement after administration of study treatment.|||ng/mL||Standard Deviation|Mean
2583675|NCT02364999|Secondary|Survival Rate at 55 Weeks|This outcome measure refers to the possibility of being alive at 55 weeks since start of study treatment, estimated from the Kaplan-Meier curve using the product-limit method.|55 weeks|The ITT population was used for analysis, and it included all participants who were randomized to study treatment.|||percentage of participants||95% Confidence Interval|Number
2583676|NCT02364999|Secondary|Progression Free Survival Rate at 55 Weeks|This outcome measure refers to the possibility of being progression free at 55 weeks since start of study treatment, estimated from the Kaplan-Meier curve using the product-limit method.|55 weeks|The ITT population was used for analysis, and it included all participants who were randomized to study treatment.|||percentage of participants||95% Confidence Interval|Number
2583677|NCT02364999|Secondary|Duration of Response (DOR)|DOR was defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. DOR was based on the Brookmeyer and Crowley method.|55 weeks|The analysis population included participants in ITT population (all participants who were randomized to study treatment) who had a confirmed objective response achieved by Week 19.|||weeks||95% Confidence Interval|Median
2583678|NCT02364999|Secondary|Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)|Laboratory evaluation included hematology (hemoglobin, white blood cells, platelets and absolute neutrophil count), blood chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, serum or plasma creatinine, sodium, potassium, total calcium, magnesium, blood urea nitrogen or urea, and albumin ), coagulation (international normalized ratio for prothrombin time and activated partial thromboplastin time) and urinalysis (dipstick followed by a quantitative urine protein analysis for results of 2+ or greater).|55 weeks|The analysis population included all participants who were randomized and received at least 1 dose of study treatment, and had laboratory evaluation done.|||Participants|||Count of Participants
2583679|NCT02364999|Secondary|Number of Participants With Treatment-Emergent Adverse Events|AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.|55 weeks|The analysis population included all participants who were randomized and received at least 1 dose of study treatment.|||Participants|||Count of Participants
2583696|NCT02364947|Secondary|Response Shift Drinking Risk Level (RSDRL) at Week 12|Proportion of patients with a downward shift in drinking risk level of two categories or more|Week 12|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||percentage|||Number
2583697|NCT02364947|Secondary|Change in Total Alcohol Consumption (TAC) From Baseline at Week 24||Week 24|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||g/day||Standard Error|Least Squares Mean
2583680|NCT02364999|Primary|Objective Response Rate (ORR) by Week 19|ORR refers to percentage of participants who achieved complete response (CR) or partial response (PR) by Week 19 of the study in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 which was subsequently confirmed by Week 25. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.|25 weeks|The Intent-to-Treat (ITT) population was used for analysis of ORR, and it included all participants who were randomized to study treatment.|||percentage of participants||95% Confidence Interval|Number
2583681|NCT02364947|Secondary|Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 24|All-patients-randomised set|Week 24|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||IU/L||Standard Error|Least Squares Mean
2583682|NCT02364947|Secondary|Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 12|All-patients-randomised set|Week 12|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||IU/L||Standard Error|Least Squares Mean
2583683|NCT02364947|Secondary|Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 24|All-patients-randomised set|Week 24|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||IU/L||Standard Error|Least Squares Mean
2583684|NCT02364947|Secondary|Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 12|All-patients-randomised set|Week 12|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||IU/L||Standard Error|Least Squares Mean
2583685|NCT02364947|Secondary|Change in CGI-I From Baseline at Week 24|The CGI-I scale was used to assess a patient's improvement (or worsening). The investigator or subinvestigator assesses a subject's condition relative to baseline on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse).|Week 24|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||units on a scale||Standard Error|Least Squares Mean
2583686|NCT02364947|Secondary|Change in CGI-I From Baseline at Week 12|The CGI-I scale is used to assess a patient's improvement (or worsening). The investigator or subinvestigator assesses a subject's condition relative to baseline on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse).|Week 12|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||units on a scale||Standard Error|Least Squares Mean
2583687|NCT02364947|Secondary|Change in CGI-S From Baseline at Week 24|The CGI-S scale was used by clinicians when assessing their global impression of a patient's current clinical condition. The investigator or subinvestigator used his/her clinical experience with this patient population to rate the severity of a subject's clinical condition on a 7-point scale ranging from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients).|Week 24|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||units on a scale||Standard Error|Least Squares Mean
2583688|NCT02364947|Secondary|Change in CGI-S From Baseline at Week 12|The CGI-S scale was used by clinicians when assessing their global impression of a patient's current clinical condition. The investigator or subinvestigator used his/her clinical experience with this patient population to rate the severity of a subject's clinical condition on a 7-point scale ranging from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients).|Week 12|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||units on a scale||Standard Error|Least Squares Mean
2583689|NCT02364947|Secondary|HDD Responder Rate at Week 24|Proportion of patients with ≤4 HDDs|Week 24|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||percentage|||Number
2583690|NCT02364947|Secondary|HDD Responder Rate at Week 12|Proportion of patients with ≤4 HDDs|Week 12|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||percentage|||Number
2583691|NCT02364947|Secondary|70% TAC Responder Rate at Week 24|Proportion of patients with a 70% decrease in TAC|Week 24|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||percentage|||Number
2583692|NCT02364947|Secondary|70% TAC Responder Rate at Week 12|Proportion of patients with a 70% decrease in TAC|Week 12|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||percentage|||Number
2583693|NCT02364947|Secondary|Response Low Drinking Risk Level (RLDRL) at Week 24|Proportion of patients with low or lower drinking risk level|Week 24|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||percentage|||Number
2583694|NCT02364947|Secondary|Response Low Drinking Risk Level (RLDRL) at Week 12|Proportion of patients with low or lower drinking risk level|Week 12|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||percentage|||Number
2583695|NCT02364947|Secondary|Response Shift Drinking Risk Level (RSDRL) at Week 24|Proportion of patients with a downward shift in drinking risk level of two categories or more|Week 24|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||percentage|||Number
2596359|NCT02209766|Secondary|AUC(0-tau) in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2583698|NCT02364947|Secondary|Change in Total Alcohol Consumption (TAC) From Baseline at Week 12||Week 12|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||g/day||Standard Error|Least Squares Mean
2583699|NCT02364947|Secondary|Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 24||Week 24|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||days/month||Standard Error|Least Squares Mean
2583700|NCT02364947|Primary|Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 12|The number of HDDs is defined as the number of days per month [days/month] with alcohol consumption of > 60 g for males and > 40 g for females|Week 12|Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.|||days/month||Standard Error|Least Squares Mean
2583701|NCT02364778|Secondary|Diameter Stenosis (DS)|Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Side Branch Ostium Diameter Stenosis (DS).|day 1||||percentage of 100||Standard Error|Mean
2583702|NCT02364778|Secondary|SB Ostial Involvement|Optical coherence tomography - a high resolution intravascular imaging technique to assess side branch ostial involvement. Side branch area will be measured by QAngio OCT software (Medis). Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Minimal lumen diameter (MLD)|day 1||||mm||Standard Error|Mean
2583703|NCT02364778|Secondary|SB Angle|Optical coherence tomography - a high resolution intravascular imaging technique to assess side branch (SB) angle. Side branch angle will be measured by QAngio XA 3D software (Medis). Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Bifurcation angles (BA)|day 1||||degree||Standard Error|Mean
2583704|NCT02364778|Primary|MLD SB Diameter|Optical coherence tomography (OCT) - a high resolution intravascular imaging technique to assess side branch size. Side branch diameter will be measured by QAngio OCT software from Medis. Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Main vessel minimal lumen diameter (MLD)|day 1||||mm||Standard Error|Mean
2583705|NCT02364700|Secondary|Stroke Impact Scale --Hand Sub Scale (SIS-H)|"The Stroke Impact Scale is a stroke-specific questionnaire evaluating quality of life in stroke survivors over eight domains. Each domain is scored independently on an ordinal scale ranging from 0 (minimum) bto a maximum of 5. Only the Hand sub-score was used in this study. Scores for each domain are transformed and range from 0-100.~Formula for scoring domains:~Transformed Scale = [(Actual raw score - lowest possible raw score) / Possible raw score] * 100"|baseline to 6 weeks (discharge)||||units on a scale||Standard Deviation|Mean
2583706|NCT02364700|Secondary|Hand Dynamometry|A dynamometer measures grip strength in kilograms|baseline to 6 weeks (discharge)||||kilograms||Standard Deviation|Mean
2583707|NCT02364700|Secondary|Stroke Upper Limb Capacity Scale (SULCS)|The SULCs is a performance based measure of upper limb capacity after stroke. Each of the 10 items are administered in a hierarchical order and assigned a score of 0 (unable to complete) or 1 (able to complete the task) with a maximum score of 10.|Baseline to 6 weeks (discharge)||||units on a scale||Standard Deviation|Mean
2583708|NCT02364700|Primary|Box and Blocks|The Box and Blocks is a performance-based functional assessment of hand dexterity ( gross grasp and release). The total score is the number of 2.5cc blocks successfully transferred from one box to another with the affected hand in one minute.|Baseline to 6 weeks (discharge)||||totally number of blocks transferred||Standard Deviation|Mean
2583709|NCT02364700|Primary|Arm Motor Ability Test (AMAT)|The AMAT is performance based measure of functional ability of the affected arm and hand in unilateral and bilateral everyday tasks. It is comprised of 10 functional tasks such as cutting meat with a knife and fork, donning a t-shirt, and phone use with a score ranging from 0 to a maximum of 5 for each item. The total score is the mean score for all individual item scores.|Baseline to 6 weeks (discharge)||||units on a scale||Standard Deviation|Mean
2583710|NCT02364700|Primary|Fugl-Meyer Assessment of Upper Extremity (FMA)|The FMA is a performance based evaluation of upper limb impairment of the affected arm after stroke. Scoring is based on an ordinal scale of 0 (no movement) to 2 (normal movement). Scoring is based on sum of 30 items, ranging from 0-60.|baseline to 6 weeks (discharge)||||units on a scale||Standard Deviation|Mean
2583711|NCT02364570|Secondary|Endothelin-I|Endothelin-I concentrations evaluated on the basis as change from baseline to calculate endothelin-I area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in endothelin-I from 0 min to 180 min (i.e., AUC (endothelin-I 0 min- 0 min, endothelin-I 30 min-0 min, endothelin-I 60 min-0 min, etc)|Area under the curve for endothelin-I for 3 hours (0, 30, 60, 90, 120 min)||||pg/mL*min||Standard Error|Mean
2583712|NCT02364570|Secondary|Angiotensin-II|Angiotensin-II concentrations evaluated on the basis as change from baseline to calculate angiotensin-II area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in angiotensin-II from 0 min to 180 min (i.e., AUC (angiotensin-II 0 min- 0 min, angiotensin-II 30 min-0 min, angiotensin-II 60 min-0 min, etc)|Area under the curve for angiotensin-II for 3 hours (0, 30, 60, 90, 120 min)||||pg/mL*min||Standard Error|Mean
2583713|NCT02364570|Secondary|Symmetric Dimethylarginine/Arginine (SDMA/Arg)|SDMA/Arg concentrations evaluated on the basis as change from baseline to calculate SDMA/Arg area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in SDMA/Arg from 0 min to 180 min (i.e., AUC (SDMA/Arg 0 min- 0 min, SDMA/Arg 30 min-0 min, SDMA/Arg 60 min-0 min, etc)|Area under the curve for SDMA/Arg for 3 hours (0, 30, 60, 90, 120 min)||||(nmol/L)/(umol/L)*min||Standard Error|Mean
2583714|NCT02364570|Secondary|Asymmetric Dimethylarginine/Arginine (ADMA/Arg)|ADMA/Arg concentrations evaluated on the basis as change from baseline to calculate ADMA/Arg area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in ADMA/Arg from 0 min to 180 min (i.e., AUC (ADMA/Arg 0 min- 0 min, ADMA/Arg 30 min-0 min, ADMA/Arg 60 min-0 min, etc)|Area under the curve for ADMA/Arg for 3 hours (0, 30, 60, 90, 120 min)||||(nmol/L)/(umol/L)*min||Standard Error|Mean
2583917|NCT02361736|Primary|Concentration of IL-18 in Urine on 5 Time Point|IL-18 is mainly created from proximal kidney tubules which is a proinflammatory factor that can be detected in earlier urine of AKI animal models.|-1d, 0d, 1d, 3d, 5d after surgery||||μg/L||Standard Deviation|Mean
2583715|NCT02364570|Secondary|Arginine (Arg)|Arginine concentrations evaluated on the basis as change from baseline to calculate arginine area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in arginine from 0 min to 180 min (i.e., AUC (arginine 0 min- 0 min, arginine 30 min-0 min, arginine 60 min-0 min, etc)|Area under the curve for arginine for 3 hours (0, 30, 60, 90, 120 min)||||umol/L*min||Standard Error|Mean
2583716|NCT02364570|Secondary|Nitric Oxide Metabolites (Nitrites/Nitrates) (NOx)|Biomarker of nitric oxide homeostasis is based on the assessment of total nitrite and nitrate concentrations. Changes relative to baseline were used to calculate area under the curve of total nitric oxide metabolites from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in nitric oxide homeostasis from 0 min to 180 min (i.e., AUC (NOx 0 min- 0 min, NOx 30 min-0 min, NOx 60 min-0 min, etc)|Area under the curve for NOx for 3 hours (0, 30, 60, 90, 120 min)||||umol/L*min||Standard Error|Mean
2583717|NCT02364570|Secondary|8-isoprostaglandin-F2a/Arachidonic Acid|8-isoprostaglandin-F2a/arachidonic acid concentrations evaluated on the basis as change from baseline to calculate 8-isoprostaglandin-F2a/arachidonic acid area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in 8-isoprostaglandin-F2a/arachidonic acid from 0 min to 180 min (i.e., AUC (8-isoprostaglandin-F2a/arachidonic acid 0 min- 0 min, 8-isoprostaglandin-F2a/arachidonic acid 30 min-0 min, 8-isoprostaglandin-F2a/arachidonic acid 60 min-0 min, etc)|Area under the curve for 8-isoprostaglandin-F2a/arachidonic acid for 3 hours (0, 30, 60, 90, 120 min)||||(pmol/L)/(umol/L)*min||Standard Error|Mean
2583718|NCT02364570|Secondary|Arachidonic Acid (AA)|Arachidonic acid concentrations evaluated on the basis as change from baseline to calculate arachidonic acid area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in arachidonic acid from 0 min to 180 min (i.e., AUC (arachidonic acid 0 min- 0 min, arachidonic acid 30 min-0 min, arachidonic acid 60 min-0 min, etc)|Area under the curve for arachidonic acid for 3 hours (0, 30, 60, 90, 120 min)||||umol/L*min||Standard Error|Mean
2583719|NCT02364570|Secondary|8-isoprostaglandin-F2a|8-isoprostaglandin-F2a concentrations evaluated on the basis as change from baseline to calculate 8-isoprostaglandin-F2a area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in 8-isoprostaglandin-F2a from 0 min to 180 min (i.e., AUC (8-isoprostaglandin-F2a 0 min- 0 min, 8-isoprostaglandin-F2a 30 min-0 min, 8-isoprostaglandin-F2a 60 min-0 min, etc)|Area under the curve for 8-isoprostaglandin-F2a for 3 hours (0, 30, 60, 90, 120 min)||||pmol/L*min||Standard Error|Mean
2583720|NCT02364570|Secondary|Methylglyoxal (MGO)|MGO concentrations evaluated on the basis as change from baseline to calculate MGO area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in MGO from 0 min to 180 min (i.e., AUC (MGO 0 min- 0 min, MGO 30 min-0 min, MGO 60 min-0 min, etc)|Area under the curve for methylglyoxal for 3 hours (0, 30, 60, 90, 120 min)||||nmol/L*min||Standard Error|Mean
2583721|NCT02364570|Secondary|Cholecystokinin (CCK)|CCK concentrations evaluated on the basis as change from baseline to calculate CCK area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in CCK from 0 min to 180 min (i.e., AUC (CCK 0 min- 0 min, CCK 30 min-0 min, CCK 60 min-0 min, etc)|Area under the curve for 3 hours (0, 30, 60, 90, 120 minutes)||||pmol/L*min||Standard Error|Mean
2583722|NCT02364570|Secondary|Insulin|Insulin concentrations evaluated on the basis as change from baseline to calculate insulin area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in insulin from 0 min to 180 min (i.e., AUC (Insulin 0 min- 0 min, insulin 30 min-0 min, insulin 60 min-0 min, etc)|Area under the curve for plasma insulin for 3 hours (0, 30, 60, 90, 120 min)||||mmol/L*min||Standard Error|Mean
2583723|NCT02364570|Secondary|Oxidative Stress Biomarker (Malondialdehyde; MDA)|MDA concentrations evaluated on the basis as change from baseline to calculate MDAarea under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in MDA from 0 min to 180 min (i.e., AUC (MDA 0 min- 0 min, MDA 30 min-0 min, MDA 60 min-0 min, etc)|Area under curve of MDA for 3 hours (0, 30, 60, 90, 120, 150, 180 min)||||umol/L*min||Standard Error|Mean
2583724|NCT02364570|Secondary|Glucose|Glucose concentrations evaluated on the basis as change from baseline to calculate glucose area under the curve from 0-180 min, i.e. Area Under the Curve (AUC) of change from baseline in glucose from 0 min to 180 min (i.e., AUC (glucose 0 min- 0 min, glucose 30 min-0 min, glucose 60 min-0 min, etc)|Area under the curve for plasma glucose for 3 hours (0, 30, 60, 90, 120 min)||||mmol/L*min||Standard Error|Mean
2583725|NCT02364570|Primary|Vascular Endothelial Function|Flow mediated dilation (FMD) evaluated on the basis as change from baseline to calculate FMD area under the curve from 0-180 min, i.e. i.e. Area Under the Curve (AUC) of change from baseline in FMD from 0 min to 180 min (i.e., AUC (FMD 0 min- 0 min, FMD 30 min-0 min, FMD 60 min-0 min, etc)|Area under the curve of brachial artery FMD for 3 hours (0, 30, 60, 90, 120 min)||||%FMD*min||Standard Error|Mean
2583726|NCT02364388|Primary|OA/US Sensitivity (Upgrade (%) for BI-RADS 4A & 4B) of Malignant Masses|Outcome is the percentage of malignant masses correctly identified by (OA/US) ultrasonography as BI-RADS 4a or higher. BI-RADS is the Breast Imaging Reporting and Data System established the American College of Radiology. BI-RADS scores range from 0 to 6, with increase in score indicating an increase in the probability of malignancy. A BI-RADS score of 4 or more indicates the need for biopsy. Sensitivity is reported with a 96% confidence interval using a normal approximation.|CDU images and decision to biopsy to be done at Screening. OA/US imaging to be done within 10 days of Screening. Biopsy to be done within 30 days of Screening.|The intent-to-diagnose population of participants with malignant masses. This is the ITD population of masses for sensitivity.|||percentage of masses|Masses|96% Confidence Interval|Mean
2583727|NCT02364388|Primary|OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses|Outcome is the percentage of benign masses correctly downgraded by (OA/US) ultrasonography from a suspicious abnormality (4A or 4B) to benign or probably benign (BI-RADS 2 or 3). BI-RADS is the Breast Imaging Reporting and Data System established the American College of Radiology. BI-RADS scores range from 0 to 6, with increase in score indicating an increase in the probability of malignancy. A BI-RADS score of 4 or more indicates the need for biopsy. Specificity is reported with a 96% confidence interval using a normal approximation.|CDU images and decision to biopsy to be done at Screening. OA/US imaging to be done within 10 days of Screening. Biopsy to be done within 30 days of Screening.|The intent-to-diagnose population of participants with benign masses. This is the ITD population of masses for specificity.|||percentage of masses|Masses|96% Confidence Interval|Mean
2583728|NCT02364336|Secondary|Change in Natural Killer (NK) Cell Degranulation|NK cell degranulation is calculated as 100*(degranulated NK cells)/(NK cells). Changes are calculated by subtracting baseline from 6 hours after first peginterferon injection.|6 hours after first injection of peginterferon and baseline|One patient with HBeAg positive had insufficient liver tissue to obtain frequency and degranulation measurement in liver.|||% of NK cells||Standard Deviation|Mean
2583729|NCT02364336|Secondary|Change in Natural Killer (NK) Cell Frequency|NK cell frequency is calculated as 100*(NK cells)/(mononuclear cells). Changes are calculated by subtracting baseline from 6 hours after first peginterferon injection.|6 hours after first injection of peginterferon and baseline|One patient with HBeAg positive had insufficient liver tissue to obtain frequency and degranulation measurement in liver.|||percentage of mononuclear cells||Standard Deviation|Mean
2583730|NCT02364336|Secondary|Hepatitis B s Antigen (HBsAg) Loss|Proportion of HBsAg positive patients showing sAG loss at end of treatment and 24 and 48 weeks off peginterferon treatment|End of treatment, 24 weeks, and 48 weeks||||Participants|||Count of Participants
2583731|NCT02364336|Secondary|Hepatitis B e Antigen (HBeAg) Loss|Proportion of HBeAg positive patients showing eAg loss at end of treatment, and 24 and 48 weeks off peginterferon treatment.|End of treatment, 24 weeks, and 48 weeks|Outcome only applies to HBeAg positive patients|||Participants|||Count of Participants
2583732|NCT02364336|Primary|Change in Interferon-stimulated-gene (ISG) Expression|Change in level of ISG expression before and after 1st peginterferon injection|6 hours after first injection of peginterferon|One patient with HBeAg positive had insufficient liver tissue to perform the RNASeq.|||log 2 fold change||Standard Error|Mean
2583733|NCT02364180|Primary|Percent Change in the Amplitude of Evoked Compound Muscle Action Potential by Electromyography Between the First to Fifth Response|Normally when a nerve is rapidly stimulated the successive Compound Muscle Action Potentials (CMAP) are of the same height. We are hoping to investigate if chronic pyridostigmine therapy reduces the margin of safety and hence the successive CMAPs may be smaller than the preceding ones.|Baseline measurement only. First and Fifth stimuli delivered 2 seconds apart on the same day. There are no additional days/times.||||percent change||Full Range|Median
2583734|NCT02364076|Secondary|Number of Participants With New-Onset Severe Adverse Events||24 months||||Participants|||Count of Participants
2583735|NCT02364076|Secondary|Overall Survival|Time between start of treatment and death|24 months||||months||95% Confidence Interval|Median
2583736|NCT02364076|Secondary|Progression-free Survival|Time between start of treatment and tumor progression or death|24 months||||months||95% Confidence Interval|Median
2583737|NCT02364076|Primary|Response Rate|To measure response of all the participants to the drug at the end of the study.|24 months||||Participants|||Count of Participants
2583738|NCT02364037|Secondary|Same Day LARC Insertion|Of the participants who chose LARC as their preferred method, the number who received the device the same day as their enrollment visit.|On the day of enrollment||||Participants|||Count of Participants
2583739|NCT02364037|Secondary|Participants Choosing Long-Acting Reversible Contraception (LARC) at Enrollment Visit|Number of women choosing an IUD or implant as their preferred contraceptive method|On the day of enrollment||||Participants|||Count of Participants
2583740|NCT02364037|Primary|Contraceptive Method Use Upon Enrollment Completion|This measure indicates the contraceptive method that the patient left with after the clinical visit on the day of enrollment. Patients could have received desired new method, received a bridge method, stayed on current method, or received no method.|On the day of enrollment||||Participants|||Count of Participants
2583741|NCT02364037|Primary|Desired Contraceptive Method at Enrollment Visit|This could be a new method, an existing method, or nothing if participant did not choose a method|On the day of enrollment||||Participants|||Count of Participants
2583742|NCT02363959|Other Pre-specified|Bronchial Epithelial Gene Expression||12 months||2019-12-31|12/2019||||
2583743|NCT02363959|Secondary|Number of Subjects With Development of Bronchitis Obliterans Syndrome||12 months||||Participants|||Count of Participants
2583744|NCT02363959|Secondary|Number of Subjects With Development of Clinically Significant Lung Infection|As defined by initiation of antimicrobials to treat the suspected organism.|12 months||||Participants|||Count of Participants
2583745|NCT02363959|Secondary|Number of Subjects Receiving Balloon Bronchoplasty for Management of Stenosis||12 months||||Participants|||Count of Participants
2583746|NCT02363959|Secondary|Number of Subjects With Development of Clinically Significant Airway Stenosis||12 months||||Participants|||Count of Participants
2583747|NCT02363959|Primary|Number of Subjects Experiencing Acute Cellular Rejection as Determined by Transbronchial Lung Biopsy|Pathologic specimens will be examined for the presence of acute cellular rejection.|12 months||||Participants|||Count of Participants
2583748|NCT02363959|Primary|Subjects Needing Airway Stent Placement as Determined by Transbronchial Lung Biopsy.|Airways with stenosis refractory to serial balloon dilation x 3, or at risk for acute obstruction due to stenosis were treated with airway stents.|12 months||||Participants|||Count of Participants
2583749|NCT02363946|Secondary|Mean Percentage Change in Circulating Blood Levels of Complement Factors 2 Hours Post-Dose||Pre-dose, 2 hours post-dose|Participants with available data for given parameter.|||percentage change||Standard Deviation|Mean
2583750|NCT02363946|Secondary|Mean Percentage Change in Circulating Blood Levels of Cytokines 2 Hours Post-Dose||Pre-dose, 2 hours post-dose|Participants with available data for given parameter.|||percentage change||Standard Deviation|Mean
2583751|NCT02363946|Secondary|Number of Participants With a Return From Nadir AAT Blood Levels to Above Normal or Within 15% of Baseline in > 100 Days|Baseline AAT levels consisted of a geometric mean based on 3 assessments taken prior to study drug administration: at 2 time points during the Screening window at least 5 days apart, and on Day -1.|Baseline, up to Day 29, and through 100 days of follow-up|All participants|||participants|||Number
2583752|NCT02363946|Secondary|Maximum Percentage Reduction in Mean AAT (Nadir of Mean AAT)||Study Day for Nadir of Mean AAT: Day 8 (for Part B 2 mg/kg arm), Day 15 (for Part A 0.38 mg/kg, 2 mg/kg, 4 mg/ kg, Placebo arms; Part B 4 mg/kg, Placebo arms), Day 22 (Part A 3 mg/kg, 5 mg/kg, 6 mg/kg, 7 mg/kg arms), Day 29 (1 mg/kg, 8 mg/kg arms)|All participants who received a full dose of study drug.|||percentage reduction|||Number
2605716|NCT02107014|Primary|Change in NGF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2583753|NCT02363946|Secondary|Number of Participants With AAT Reduction > 30% From Baseline (First Occurrence)|Data presents the study visit day upon which a participant had the first occurrence of AAT reduction of > 30% from Baseline, and the number of participants who had a > 30% reduction at any visit (overall). Baseline AAT levels consisted of a geometric mean based on 3 assessments taken prior to study drug administration: at 2 time points during the Screening window at least 5 days apart, and on Day -1.|Baseline, Days 3, 8, 15, 22 and 29|All participants who received a full dose of study drug with evaluable data at given time point.|||participants|||Number
2583754|NCT02363946|Primary|Percentage Reduction From Baseline of AAT Up to Day 29|Clinical assay for total serum AAT level was used for Part A. A quantitative measurement of AAT was used for Part B. A negative percent reduction indicates a percentage increase. Baseline AAT levels consisted of a geometric mean based on 3 assessments taken prior to study drug administration: at 2 time points during the Screening window at least 5 days apart, and on Day -1.|Baseline, Days 3, 8, 15, 22 and 29|All participants who received a full dose of study drug with evaluable data at given time point.|||percentage reduction||Standard Deviation|Mean
2583755|NCT02363946|Primary|Pharmacokinetics of ARC-AAT: Half-Life (t1/2) for the Analytes AD00370 and ARC-MLP (Part A)||Day 1, 2, and 3 at pre-dose and then at 0.08, 0.5, 1, 3, 6, 24 and 48 hours post-dose|Per protocol pharmacokinetic analysis set: all participants with evaluable concentration time profiles for each dose level who had no major protocol violations|||hours||Standard Deviation|Mean
2583756|NCT02363946|Primary|Pharmacokinetics of ARC-AAT: Terminal Elimination Rate Constant Obtained From the Slope of the Line (Kel) for the Analytes AD00370 and ARC-MLP (Part A)||Day 1, 2, and 3 at pre-dose and then at 0.08, 0.5, 1, 3, 6, 24 and 48 hours post-dose|Per protocol pharmacokinetic analysis set: all participants with evaluable concentration time profiles for each dose level who had no major protocol violations|||1/hour||Standard Deviation|Mean
2583757|NCT02363946|Primary|Pharmacokinetics of ARC-AAT: Area Under the Plasma Concentration Versus Time Curve From From Zero to Infinity (AUCinf) for the Analytes AD00370 and ARC-MLP (Part A)||Day 1, 2, and 3 at pre-dose and then at 0.08, 0.5, 1, 3, 6, 24 and 48 hours post-dose|Per protocol pharmacokinetic analysis set: all participants with evaluable concentration time profiles for each dose level who had no major protocol violations|||hr*ng/mL||Standard Deviation|Mean
2583758|NCT02363946|Primary|Pharmacokinetics of ARC-AAT: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time 24 Hours (AUC0-24) for the Analytes AD00370 and ARC-MLP (Part A)||Day 1, 2, and 3 at pre-dose and then at 0.08, 0.5, 1, 3, 6, 24 and 48 hours post-dose|Per protocol pharmacokinetic analysis set: all participants with evaluable concentration time profiles for each dose level who had no major protocol violations|||hr*ng/mL||Standard Deviation|Mean
2583759|NCT02363946|Primary|Pharmacokinetics of ARC-AAT: Time to Maximum Observed Concentration (Tmax) for the Analytes AD00370 and ARC-MLP (Part A)||Day 1, 2, and 3 at pre-dose and then at 0.08, 0.5, 1, 3, 6, 24 and 48 hours post-dose|Per protocol pharmacokinetic analysis set: all participants with evaluable concentration time profiles for each dose level who had no major protocol violations|||hour||Full Range|Median
2583760|NCT02363946|Primary|Pharmacokinetics of ARC-AAT: Maximum Observed Plasma Concentration (Cmax) for the Analytes AD00370 and ARC-Melittin-Like Peptide (MLP; Part A)||Day 1, 2, and 3 at pre-dose and then at 0.08, 0.5, 1, 3, 6, 24 and 48 hours post-dose|Per protocol pharmacokinetic analysis set: all participants with evaluable concentration time profiles for each dose level who had no major protocol violations|||ng/mL||Standard Deviation|Mean
2583761|NCT02363946|Primary|Number of Participants With Clinically Significant Treatment-Emergent Abnormalities in Vital Signs, Electrocardiograms (ECGs), Pulmonary Function, Physical Findings, and Other Observations|Values collected include: vital signs (clinically concerning or symptomatic treatment emergent changes in heart rate, systolic blood pressure, diastolic blood pressure, respiratory rate, or temperature); ECGs (clinically significant changes from baseline were observed for ventricular rate, RR interval, QRS duration, QT interval or QT interval corrected for heart rate using Fridericia's formula [QTcF]; treatment emergent clinically significant changes in ST segments, P wave or T wave morphology; cardiac telemetry monitoring); clinically significant abnormal physical examination findings; treatment emergent sensitivity to bee venom; pulmonary function (clinically significant worsening in spirometry parameters and carbon monoxide diffusing capacity of the lung for carbon monoxide [DLCO]).|Day 1 through Day 29 ± 1 day|All participants receiving at least 1 dose of study medication|||participants|||Number
2583762|NCT02363946|Primary|Number of Participants With Clinically Significant Treatment-Emergent Abnormalities in Laboratory Values|Laboratory values collected include: hematology (haemoglobin, lymphocytes, neutrophils, platelets, white cell count, monocytes); biochemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, bilirubin, creatine kinase, creatinine, gamma-glutamyltransferase, fasting glucose, troponin I); coagulation parameters (fibrinogen, international normalized ratio); and C-reactive protein.|Day 1 through Day 29 ± 1 day|All participants receiving at least 1 dose of study medication|||participants|||Number
2583763|NCT02363946|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Discontinuations Due to TEAEs|An adverse event (AE) is defined as any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as defined as AEs with onset after administration of the study drug, or when a preexisting medical condition increases in severity or frequency after study drug administration. SAEs are defined as is an AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction.|From the first dose of study treatment through Day 29 ± 1 day|All participants receiving at least 1 dose of study medication|||participants|||Number
2583764|NCT02363933|Secondary|Percentage of Patients Who Experience a Adverse Event Possibly, Probably, or Definitely Attributable to Perampanel Treatment|The percentage of patients with unacceptable adverse events that are possibly, probably, or definitely related to perampanel treatment will be calculated. Unacceptable adverse events include all Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 Grade 4 or 5 toxicities that are possibly, probably, or definitely related to perampanel, as well as suicidal ideation (any grade) or suicide attempt (Grade 3-5).|24 Weeks|All patients treated with perampanel is included in the attributable adverse event rate.|||percentage of participants|||Number
2583765|NCT02363933|Primary|Percentage of Patients With ≥50% Seizure Reduction During the Maintenance Period Compared With Seizure Frequency Before Initiation of Perampanel|The primary objective of this study is to assess the efficacy of perampanel as an adjunctive anti-epileptic drug (AED) in patients with primary glioma presenting refractory partial onset seizure activity. Efficacy will be assessed by the 50% responder rate, defined as the percentage of patients with a ≥50% seizure reduction during the maintenance period compared with the seizure frequency before initiation of perampanel. Seizure frequency during maintenance perampanel will be computed as the ratio of the total number of seizure episodes while receiving perampanel during the maintenance period and the number of days perampanel is administered|20 Weeks|Seizure frequency was not systematically gathered at screening. As the 50% responder rate requires an adequate baseline comparison, it is not possible to compute the 50% responder rate.||||||
2583766|NCT02363907|Primary|Point Accuracy of CGM ISF Readings to Blood Glucose Measured by a Reference Device|"Point Accuracy was evaluated in terms of the percentage of CGM values that were within ±20% of glucose meter reference value for glucose levels >80 mg/dL and ±20 mg/dL of glucose meter reference values for glucose levels <80 mg/dL"|Measured during clinic session during 7 day sensor wear period||||Percentage of matched pairs w/i %20/20||95% Confidence Interval|Number
2583767|NCT02363803|Secondary|Change in Spontaneous Pain Intensity as a Function of Baseline HPT|Correlation between Heat Pain Threshold (HPT in degrees Celsius) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at 60-120 minutes (averaged) from the study drug infusion. The slopes (Pearson coefficients) of the correlation obtained from lidocaine vs. placebo will be compared.|Baseline to 60-120 minutes after starting the infusion|Participants who completed both infusions and had non-zero pain scores at the start of each infusion. Two additional participants excluded as they could not sense heat on test site.|||Pearson coefficient||95% Confidence Interval|Number
2583768|NCT02363803|Secondary|Change in Spontaneous Pain Intensity as a Function of Baseline MPT|Correlation between Mechanical Pain Threshold (MPT in mN) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at 60-120 minutes (averaged) from the study drug infusion. The slopes (Pearson coefficients) of the correlation obtained from lidocaine vs. placebo will be compared.|baseline to 60-120 minutes after starting the infusion|Participants who completed both infusions and had non-zero pain scores at the start of each infusion.|||Pearson coefficient||95% Confidence Interval|Number
2583769|NCT02363803|Secondary|NPSI (Neuropathic Pain Symptom Inventory) Descriptors of Pain at Baseline and 60 Min After Infusion|NPSI pain descriptors will be assessed prior to infusion of placebo and lidocaine (baseline) and again at 60 minutes post-infusion. Descriptors are expressed on a 0-10 scale; 0-minimum (least), and 10 maximum (worst) score.|Baseline to 60 minutes of initiating infusion|Participants who received both lidocaine and normal saline infusions analyzed.|||score on a scale||Inter-Quartile Range|Median
2583770|NCT02363803|Secondary|Evoked Mechanical and Thermal Sensation at Baseline and 60 Minutes After Infusion Initiation.|Thermal and mechanical responses will be assessed at baseline and 60 minutes after infusions. Evoked intensities measured on a 0-10 sensory scale, where 5 is normal sensation, a number lower than 5 is reduced sensation and a number higher than 5 is greater sensation.|- 60 minutes (baseline) and + 60 minutes of initiating infusion|Participants who received both lidocaine and normal saline infusions were analyzed.|||score on a scale||Inter-Quartile Range|Median
2583771|NCT02363803|Primary|Change in Spontaneous Pain at 60-120 Minutes After Lidocaine Infusion Initiated (Assessed on 0-10 NRS)|Spontaneous pain will be assessed on numerical rating scale NRS (0= no pain, 10=worst pain imaginable) prior to infusion and then repeatedly for 120 minutes. The outcome measure will use the average of pain intensity measured at timepoints in the 60-120 min range after beginning of infusion. The mean %change in pain (from baseline) will be compared between lidocaine and placebo arms.|Baseline compared to 60-120 minutes after starting the infusion|Participants who completed both infusions and had non-zero pain scores at the start of each infusion.|||percentage of pain change from baseline||Standard Deviation|Mean
2583772|NCT02363621|Secondary|Number of Participants With Post Injection Pain Above 0 on a 11 Point Pain Scale.|"Pain score rated on a 11 point numerical rating from 0-10 administered to each patient verbally at visit #1 and visit #2.~0 = no pain 10 = severe pain"|24 to 48 hours visit #1 and 5 to 7 days visit #2||||Participants|||Count of Participants
2583773|NCT02363621|Primary|Number of Participants With Intraocular Inflammation|Number of Participants With Intraocular Inflammation as seen on slit lamp and dilated fundus exam|5 to 7 days (visit #2)|Inflammation 5 to 7 days after injection|||Participants|||Count of Participants
2583774|NCT02363621|Primary|Number of Participants With Intraocular Inflammation|Number of participants with intraocular inflammation as seen on slide lamp and dilated fundus exam.|24 to 48 hours (visit #1)||||Participants|||Count of Participants
2583775|NCT02363478|Secondary|Changes in the Severity of Esophageal Symptoms at Week 4|Severity of esophageal symptoms (dysphagia, heartburn, regurgitation and chest pain) was measured on a 100-point visual analogue scale (VAS) ranging from 0 (absent) to 100 (very severe). Even minor decrease in the VAS score for each symptom at week 4 considered as improvement.|before and after 4 weeks buspirone administration||||units on a scale||Standard Deviation|Mean
2583776|NCT02363478|Primary|Changes From Baseline in Manometric Parameters: Velocity of Contractions at the Distal Part of the Esophagus at Week 4||before and after 4 weeks buspirone administration||||cm/sec||Standard Deviation|Mean
2583777|NCT02363478|Primary|Changes From Baseline in Manometric Parameters: Duration of Contractions at the Distal Part of the Esophagus at Week 4||before and after 4 weeks buspirone administration||||sec||Standard Deviation|Mean
2583778|NCT02363478|Primary|Changes From Baseline in Manometric Parameters: i) Amplitude of Contractions at the Distal Part of the Esophagus and ii) Resting and Residual (Lower Esophageal Pressure) LES Pressure and IRP (Integrated Relaxation Pressure) at Week 4||before and after 4 weeks buspirone administration||||mmHg||Standard Deviation|Mean
2583779|NCT02363439|Primary|Number of Participants With Adverse Events|Long term safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia|During receipt of study treatment on the trial.|Safety population|||Participants|||Count of Participants
2583780|NCT02363322|Secondary|Plasma Viral Load|Time to viral clearance|28 days||||days||Full Range|Median
2583781|NCT02363322|Secondary|Number of Participants With ZMapp Infusion-related Adverse Events|Adverse events related to ZMapp infusions|10 Days|Arm A Received the Current Standard of Care Alone and not the ZMapp infusion|||participants|||Number
2583782|NCT02363322|Primary|Mortality|Death at Day 28|28 days|Seven of the eight deaths recorded in ZMapp recipients occurred before day 4, before the second of three planned infusions of ZMapp. The exception was one patient who received a second infusion on day 4 and died later that day. In the group that received the current standard of care alone, all 13 deaths occurred during the first 8 days of follow-up|||Participants|||Count of Participants
2583783|NCT02363270|Primary|Overall Rate of Feeling Unreality|Overall rate of feeling of unreality as measured by Side Effects Rating Scale for Dissociative Anesthetics (SERSDA)|30 minutes||||Participants|||Count of Participants
2583784|NCT02362789|Primary|Pruritus Intensity Visual Analogue Scale Score at Week 32|On a 100-mm horizontal line, the patient placed a mark representing their perception of worst itching (pruritus) within a recall period of 24 hours, where 0 = no pruritus and 100 = most severe pruritus.|Week 32|FAS-R, LOCF|||Units on a scale||Standard Error|Least Squares Mean
2583785|NCT02362646|Secondary|Functional Status|functional status, defined by the number of temporary weans from LVAD support tolerated|up to 12 months|||||||
2583786|NCT02362646|Secondary|Hospital Costs|Hospital resource use|up to 12 months|||||||
2583787|NCT02362646|Secondary|Hospitalizations|Frequency and cause of readmissions|up to 12 months|||||||
2583788|NCT02362646|Secondary|Length of Stay|Length of stay of index hospitalization|up to 12 months|||||||
2583789|NCT02362646|Secondary|Controlled Oral Word Association|Cognitive performance will be assessed using the Controlled Oral Word Association. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.|3 months and 12 months|||||||
2583790|NCT02362646|Secondary|Digit Symbol Substitution Test|Cognitive performance will be assessed using the Digit Symbol Substitution Test. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.|3 months and 12 months|||||||
2583791|NCT02362646|Secondary|Digit Span|Cognitive performance will be assessed using the MCG Complex Figures. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.|3 months and 12 months|||||||
2583792|NCT02362646|Secondary|MCG Complex Figures|Cognitive performance will be assessed using the MCG Complex Figures. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.|3 months and 12 months|||||||
2583793|NCT02362646|Secondary|Trailmaking Tests A and B|Cognitive performance will be assessed using Trailmaking Tests A and B. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.|3 months and 12 months|||||||
2583794|NCT02362646|Secondary|Hopkins Verbal Learning Test|Cognitive performance will be assessed Hopkins Verbal Learning Test. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.|3 months and 12 months|||||||
2583795|NCT02362646|Secondary|Change in Quality of Life (QoL)|Quality of life will be assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ), a widely used tool in heart failure populations, and the Short Form 12 (SF12), a widely used overall health status measure.|6 months and 12 months|||||||
2583796|NCT02362646|Secondary|Overall Survival||up to 12 months|||||||
2583797|NCT02362646|Secondary|Histopathological Assessments of Myocardial Tissue||up to 12 months|||||||
2583798|NCT02362646|Secondary|Physiologic Assessments|Echocardiographic assessments of the myocardial size and function by transthoracic echocardiography with LVAD at full support, and as tolerated following 6-Minute Walk Test (MWT) while weaned from LVAD support (for patients who tolerate wean from LVAD support for 30 minutes)|up to 12 months|||||||
2583799|NCT02362646|Primary|Number of Participants With Adverse Events|Safety as assessed by number of study intervention-related adverse events|up to 6 months||||Participants|||Count of Participants
2583800|NCT02362646|Primary|Number of Temporary Weans From LVAD Support Tolerated|functional status, defined by the number of temporary weans from LVAD support tolerated over the 6 months post-randomization. A successful wean is the ability to tolerate temporary weaning from LVAD support for 30 minutes without sustained symptoms of worsening heart failure. Wean failures are defined as inability to tolerate the temporary wean for 30 minutes; death; or patient too unstable, in the judgment of the primary heart failure cardiologist, to tolerate the wean attempt.|up to 6 months||||number of weans||Standard Deviation|Mean
2583801|NCT02362594|Secondary|Number of Participants Positive for Anti-Drug Antibodies (ADA) After Pembrolizumab Treatment|Pre- and post-baseline serum samples from participants treated with pembrolizumab were analyzed for ADA by means of a neutralizing antibody assay which assessed the ability of ADA to block (neutralize) binding of pembrolizumab to Programmed Cell Death-1 (PD-1) protein. Overall immunogenicity was defined as the number of treatment emergent positive participants based on the total number of evaluable participants (treatment emergent positive, non-treatment emergent positive and negative immunogenicity status).|Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and then Day 1 of cycle for every 4 cycles afterwards (up to approximately 16 months). Each cycle is 3 weeks.|All randomized participants in Part 1 who had at least one ADA sample available after treatment with pembrolizumab and who had treatment emergent positive, non-treatment emergent positive, or negative immunogenicity status. Participants receiving Placebo treatment in Part 1 were not analyzed for ADA.|||Participants|||Count of Participants
2583802|NCT02362594|Secondary|Volume of Distribution (V) of Pembrolizumab|Blood samples were to be collected at pre-specified time points and plasma isolated for analysis of pembrolizumab V, defined as the theoretical volume that would be necessary to contain the total amount of administered pembrolizumab at the same concentration that it is observed in the blood plasma. Samples were not collected and this analysis was not performed.|Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and then Day 1 of cycle for every 4 cycles afterwards (up to approximately 16 months). Each cycle is 3 weeks.|As pre-specified by the protocol, pembrolizumab V was not analyzed as planned and no data were collected since by the time of the interim analysis, pembrolizumab PK in melanoma patients had been well characterized and found to be consistent with the overall clinical pharmacology of pembrolizumab characterized across indications.||||||
2583803|NCT02362594|Secondary|Clearance (CL) of Pembrolizumab|Blood samples were to be collected at pre-specified time points and plasma isolated for analysis of pembrolizumab CL, defined as the volume of plasma from which pembrolizumab is eliminated per unit time following IV pembrolizumab administration. Samples were not collected and this analysis was not performed.|Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and then Day 1 of cycle for every 4 cycles afterwards (up to approximately 16 months). Each cycle is 3 weeks.|As pre-specified by the protocol, pembrolizumab CL was not analyzed as planned and no data were collected since by the time of the interim analysis, pembrolizumab pharmacokinetics (PK) in melanoma patients had been well characterized and found to be consistent with the overall clinical pharmacology of pembrolizumab characterized across indications.||||||
2583804|NCT02362594|Secondary|Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)|"An AE is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (such as rash or enlarged liver), symptoms (such as nausea or chest pain), an abnormal laboratory finding (including results of blood tests, x-rays or scans) or a disease temporarily associated with the use of the protocol treatment, whether or not considered related to the investigational medicinal product. The number of participants who discontinued study treatment due to an AE was reported for all participants in each treatment arm."|Up to 22 months|All randomized participants in Part 1 who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2583805|NCT02362594|Secondary|Number of Participants Who Experienced At Least 1 Adverse Event (AE)|"An AE is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (such as rash or enlarged liver), symptoms (such as nausea or chest pain), an abnormal laboratory finding (including results of blood tests, x-rays or scans) or a disease temporarily associated with the use of the protocol treatment, whether or not considered related to the investigational medicinal product. The number of participants who experienced at least 1 AE was reported for all participants in each treatment arm."|Up to 22 months|All randomized participants in Part 1 who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2583806|NCT02362594|Secondary|Overall Survival (OS) for Participants With PD-L1-positive Tumor Expression|OS will be defined as the time from the date of randomization to the date of death, whatever the cause. The follow-up of participants still alive will be censored at the moment of last visit/contact. OS will be reported for all participants with PD-L1-positive tumors in both treatment arms.|Up to 10 years||2026-07-31|07/2026||||
2583807|NCT02362594|Secondary|Overall Survival (OS) for All Participants|OS will be defined as the time from the date of randomization to the date of death, whatever the cause. The follow-up of participants still alive will be censored at the moment of last visit/contact. OS will be reported for all participants in both treatment arms.|Up to 10 years||2026-07-31|07/2026||||
2583808|NCT02362594|Secondary|Distant Metastases-free Survival (DMFS) for Participants With PD-L1-positive Tumor Expression|"Description:~DMFS will be defined as the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first. For participants who remain alive and distant metastasis-free, DMFS will be censored on the date of last visit/contact with disease assessments. The percentage of participants with DMFS will be reported for all participants with PD-L1-positive tumors in both treatment arms."|Up to 10 years||2026-07-31|07/2026||||
2583809|NCT02362594|Secondary|Distant Metastases-free Survival (DMFS) in All Participants|DMFS will be defined as the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first. For participants who remain alive and distant metastasis-free, DMFS will be censored on the date of last visit/contact with disease assessments. The percentage of participants with DMFS will be reported for all participants in both treatment arms.|Up to 10 years||2026-07-31|07/2026||||
2583810|NCT02362594|Primary|Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among Participants With PD-L1-positive Tumor Expression|RFS was defined as the time between the date of randomization and the date of first melanoma recurrence (local, regional, distant metastasis) or death (whatever the cause), whichever occurred first. For participants who remained alive and whose disease had not recurred, RFS was censored on the date of last visit/contact with disease assessments. The percentage of participants with RFS at Month 6 was reported for all participants with PD-L1-positive tumors in both treatment arms of Part 1.|6 months|All randomized participants in Part 1 with PD-L1-positive tumors.|||Percentage of Participants||95% Confidence Interval|Number
2583811|NCT02362594|Primary|Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participants|RFS was defined as the time between the date of randomization and the date of first melanoma recurrence (local, regional, distant metastasis) or death (whatever the cause), whichever occurred first. For participants who remained alive and whose disease had not recurred, RFS was censored on the date of last visit/contact with disease assessments. The percentage of participants with RFS at Month 6 was reported for all participants in both treatment arms of Part 1.|6 months|All randomized participants in Part 1.|||Percentage of Participants||95% Confidence Interval|Number
2583812|NCT02362503|Secondary|Number of Participants With Indicated Fold Change Ratio (FCR) Using the Monogram PhenoSense Entry Assay-Randomized Cohort|The phenotypic resistance to a drug is defined in terms of a fold change (FC) in IC50s, ie, the ratio of the 50% inhibitory concentration (IC50) of the clinical isolate to the IC50 of a reference strain (wild type control). FCR was calculated as FC at PDVF divided by Baseline FC. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. FCR<1 indicates that FC is smaller on-treatment than at Baseline. FCR >3 indicates that on-treatment FC is 3 times greater than it was at Baseline. All the participants received fostemsavir during open-label period irrespective of the original arms to which they were randomized; hence, combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.|Week 48|VF Population. Only participants available at the specified time point were analyzed.|||Participants|||Count of Participants
2583918|NCT02361736|Primary|Concentration of NGAL in Urine on 5 Time Point|Neutrophil gelatinase-associated lipocalin (NGAL) is a small protein, which is filtered via the glomeruli and reabsorbed in the proximal tubules, and thus low concentrations of NGAL can be measured in the blood and urine.|-1d, 0d, 1d, 3d, 5d after surgery||||ng/ml||Standard Deviation|Mean
2583813|NCT02362503|Secondary|Number of Participants With Treatment-emergent Viral Genotypic Substitution of Interest in the GP160 Domain as a Measure of Genotypic Resistance-Randomized Cohort|Plasma samples were collected for drug resistance testing. Participants with emergent viral genotypic substitutions of interest in GP160 domain was identified by next-generation sequencing (NGS) assay. Virologic failure (VF) Population comprised of all participants with available phenotypic and genotypic resistance data meeting at the time protocol defined virologic failure (PDVF) was met. Criteria for PDVF was a) Confirmed, or last available prior to discontinuation, HIV-1 RNA >=400 c/mL at any time after prior confirmed suppression to <400 c/mL prior to Week 24 or Confirmed, or last available prior to discontinuation, >1 log10 c/mL increase in HIV-1 RNA at any time above nadir level where nadir is >=40 c/mL prior to Week 24. b) Confirmed, or last available prior to discontinuation, HIV-1 RNA >=400 c/mL at or after Week 24. All participants received fostemsavir during open-label period irrespective of original randomization; hence, combined totals for Randomized Cohort is presented.|Week 48|VF Population|||Participants|||Count of Participants
2583814|NCT02362503|Secondary|Change From Baseline in CD4+ T- Cell Count Percentage Through Week 48|CD4+ T- cell counts were assessed by flow cytometry. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.|Baseline and up to Week 48|ITT-E Population|||Percentage of CD4+ T- cells||Standard Deviation|Mean
2583815|NCT02362503|Secondary|Change From Baseline in CD4+ T- Cell Count Through Week 48-Randomized Cohort|CD4+ T- cell counts were assessed by flow cytometry. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.|Baseline and up to Week 48|ITT-E Population|||Cells per cubic millimeter||Standard Deviation|Mean
2583816|NCT02362503|Secondary|Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 48-Randomized Cohort|Blood samples were collected for the analysis of HIV-1 RNA. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles). All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.|Baseline and up to Week 48|ITT-E Population|||Log10 c/mL||Standard Deviation|Mean
2583817|NCT02362503|Secondary|Change in CD4+ T- Cell Count Percentage From Day 1 at Day 8-Randomized Cohort|CD4+ T- cell counts were assessed by flow cytometry. Mean change in CD4+ T- cell count percentage from Day 1 at Day 8 was analyzed using one-way ANCOVA with change of CD4+ cell count percentage from Day 1 at Day 8 as the dependent variable, treatment (fostemsavir or placebo) as an independent variable, and Day 1 CD4+ cell count percentage as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. Missing CD4+ cell count values at Day 8 were imputed using (a) D1OCF for participants without a value during blinded treatment (ie, imputing a zero change from Day 1), or (b) LOCF for participants with an early value during blinded treatment before the Day 8 analysis visit window.|Day 1 and Day 8|ITT-E Population. Only those participants with data available at the specified time points were analyzed.|||Percentage of CD4+T- cells||95% Confidence Interval|Least Squares Mean
2583818|NCT02362503|Secondary|Change From Day 1 in Cluster of Differentiation (CD) 4+ T-cell Count at Day 8-Randomized Cohort|CD4+ T- cell counts were assessed by flow cytometry. Mean change in CD4+ T- cell count from Day 1 at Day 8 was analyzed using one-way ANCOVA with change of CD4+ cell counts from Day 1 at Day 8 as the dependent variable, treatment (fostemsavir or placebo) as an in-dependent variable, and Day 1 CD4+ cell count as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. Missing CD4+ cell count values at Day 8 were imputed using (a) D1OCF for participants without a value during blinded treatment (i.e., imputing a zero change from Day 1), or (b) LOCF for participants with an early value during blinded treatment before the Day 8 analysis visit window.|Day 1 and Day 8|ITT-E Population. Only those participants with data available at the specified time points were analyzed.|||Cells per cubic millimeter||95% Confidence Interval|Least Squares Mean
2583819|NCT02362503|Secondary|Number of Participants With Centers for Disease Control (CDC) Class C Events-Randomized Cohort|Disease progression during open label fostemsavir plus OBT was assessed based on the occurrence of new AIDS defining events (CDC Class C events) or death. The number of participants with on-treatment CDC Class C AIDS events is presented. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.|Up to Week 48 analysis cut-off date|Safety Population|||Participants|||Count of Participants
2583820|NCT02362503|Secondary|Number of Participants With Toxicity Grade Increase in Hematology Results to Grade 3-4 Relative to Baseline-Randomized Cohort|Laboratory toxicities were graded for severity according to the DAIDS grading system: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (potentially life-threatening). Baseline is defined as the latest pre-dose assessment. The number of participants with hematology toxicity grade increase to Grade 3-4 at anytime post-Baseline relative to Baseline is presented. Only participants with data available at the specified time points were analyzed (represented by n=X in category titles). All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.|Baseline and up to Week 48 analysis cut-off date|Safety Population|||Participants|||Count of Participants
2583919|NCT02361580|Secondary|Symptoms of Depression Measured by PROMIS Depression|Symptoms of depression measured by PROMIS Depression|8 weeks|All of the subjects were lost to follow up.||||||
2583821|NCT02362503|Secondary|Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort|Laboratory toxicities were graded for severity according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading system: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (potentially life-threatening). Baseline is defined as the latest pre-dose assessment. The number of participants with clinical chemistry toxicity grade increase to Grade 3-4 at anytime post-Baseline relative to Baseline is presented. Only participants with data available at the specified time points were analyzed (represented by n=X in category titles). All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.|Baseline and up to Week 48 analysis cut-off date|Safety Population|||Participants|||Count of Participants
2583822|NCT02362503|Secondary|Number of Participants With On-treatment Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Randomized Cohort|An SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; an important medical event that may jeopardize the participant or require intervention. Number of participants with on-treatment SAEs and AEs leading to withdrawal of study treatment is presented. SAEs and AELDs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.|Up to Week 48 analysis cut-off date|Safety Population.|||Participants|||Count of Participants
2583823|NCT02362503|Secondary|Percentage of Participants With HIV-1 RNA <40 c/mL at Weeks 24 and 48-Randomized Cohort|The durability of response (that is, the number of participants achieving HIV-1 RNA <40 c/mL) at Weeks 24 and 48 of open-label fostemsavir plus OBT in the Randomized Cohort was assessed using the Food and Drug Administration (FDA) snapshot algorithm in which participants without HIV-1 RNA at Weeks 24 and 48 or those who changed OBT due to lack of efficacy through Weeks 24 and 48 were counted as failures. The percentage of participants in the Randomized Cohort who achieved virologic success (HIV-1 RNA <40 c/mL) at Weeks 24 and 48 is presented along with 95% Wilson confidence interval. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.|Weeks 24 and 48|ITT-E Population|||Percentage of participants||95% Confidence Interval|Number
2583824|NCT02362503|Secondary|Percentage of Participants With HIV-1 RNA Decreases From Day 1 That Exceed 0.5 log10 c/mL and 1.0 log10 c/mL at Day 8-Randomized Cohort|The percentage of participants in the Randomized Cohort with HIV-1 RNA decreases from Day 1 that exceed 0.5 log10 c/mL and 1.0 log10 c/mL at Day 8 was determined by comparing HIV-1 RNA Day 1 measurement of each participant to their Day 8 measurement. This was an ITT analysis that classified participants without HIV-1 RNA at Day 1 or Day 8 as failures. The percentage of responders along with 95% confidence interval based on Wilson score is presented.|Day 1 and Day 8|ITT-E Population|||Percentage of participants||95% Confidence Interval|Number
2583825|NCT02362503|Primary|Mean Change in Logarithm to the Base 10 (log10) HIV-1 Ribonucleic Acid (RNA) From Day 1 at Day 8-Randomized Cohort|Plasma samples were collected for analysis of HIV-1 RNA. Mean change in log10 HIV-1 RNA from Day 1 was estimated using analysis of covariance (ANCOVA) with log10 HIV-1 RNA change from Day 1 at Day 8 as dependent variable, treatment (fostemsavir or placebo) as an independent variable, and Day 1 log10 HIV-1 RNA as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. The analysis was performed on Intent-to-Treat Exposed (ITT-E) Population which comprised of all randomized participants who received at least one dose of study treatment. Missing HIV-1 RNA values at Day 8 were imputed using (a) Day 1 Observation Carried Forward (D1OCF) for participants without a value during blinded treatment (i.e, imputing a zero change from Day 1) or (b) Last Observation Carried Forward (LOCF) for participants with an early value during blinded treatment before the Day 8 analysis visit window.|Day 1 and Day 8|ITT-E Population. Participants with missing Day 1 HIV-1 RNA values were not analyzed.|||Log10 copies per milliliter (c/mL)||95% Confidence Interval|Least Squares Mean
2583826|NCT02362425|Other Pre-specified|Urine 15-F2t Isoprostane Concentration at Baseline|Urine will be assayed for 15-isoprostane-F2, which is formed when arachidonic acid reacts with reactive oxygen species(ROS). A validated gas chromatography(GC)-mass spectrometer (MS) method will be used to quantify 15-isoprostane-F2|Baseline|Healthy volunteers who participated in a one-visit assessment and RYR1-RM Volunteers measured at Baseline.|||ng/mg Cr||Standard Deviation|Mean
2583827|NCT02362425|Other Pre-specified|Pediatric Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score Pre-Intervention|Pediatric participants (< 18 years) were asked to complete the Peds-FACIT-F questionnaire through the NIH online, self-administered Clinical Trials Survey System.Minimum value = 0, maximum value = 52. Higher scores represent a better outcome/ better QOL.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||scores on a scale||Standard Deviation|Mean
2583828|NCT02362425|Other Pre-specified|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Trial Outcome Index Pre-Intervention|Participants were asked to complete the FACIT-F questionnaire through the NIH online, self-administered Clinical Trials Survey System. The Trial Outcome Index (TOI) is the sum of the physical well-being, functional well-being and 'additional concerns' subscales. The minimum value = 0, and maximum value = 52. Scores under 30 is considered to be severe fatigue. Higher scores represent a better outcome/QOL.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||scores on a scale||Standard Deviation|Mean
2583920|NCT02361580|Secondary|Avoidance of Painful Activities Measured by PROMIS Pain Interference|Avoidance of painful activities measured by PROMIS Pain Interference|8 weeks|All of the subjects were lost to follow up.||||||
2605717|NCT02107014|Primary|Change in VEGF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2583829|NCT02362425|Other Pre-specified|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score Pre-Intervention|Participants were asked to complete the FACIT-f questionnaire through the NIH online, self-administered Clinical Trials Survey System. Minimum value = 0, maximum value = 160. Higher scores represent a better outcome/ better QOL.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||scores on a scale||Standard Deviation|Mean
2583830|NCT02362425|Other Pre-specified|Multidimensional Fatigue Inventory-20 (MFI-20) Mental Fatigue Score Pre-Intervention|Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||scores on a scale||Standard Deviation|Mean
2583831|NCT02362425|Other Pre-specified|Multidimensional Fatigue Inventory-20 (MFI-20) Reduced Motivation Score Pre-Intervention|Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||scores on a scale||Standard Deviation|Mean
2583832|NCT02362425|Other Pre-specified|Multidimensional Fatigue Inventory-20 (MFI-20) Reduced Activity Score Pre-Intervention|Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||scores on a scale||Standard Deviation|Mean
2583833|NCT02362425|Other Pre-specified|Multidimensional Fatigue Inventory-20 (MFI-20) Physical Fatigue Score Pre-Intervention|Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||scores on a scale||Standard Deviation|Mean
2583834|NCT02362425|Other Pre-specified|Multidimensional Fatigue Inventory - 20 (MFI-20) General Fatigue Score Pre-Intervention|Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||scores on a scale||Standard Deviation|Mean
2583835|NCT02362425|Other Pre-specified|Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Fatigue Pre-Intervention|Participants were asked to complete the NeuroQoL questionnaire through the NIH online, self-administered Clinical Trials Survey System. NeuroQoL scores were normed to 100 meaning that the raw score is converted to a scale where 50 is the mean and the standard deviation is 10. Scores less than 50 indicate less fatigue compared to the average and scores over 50 indicate more fatigue than the average. Lower scores represent better outcomes.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||t score||Standard Deviation|Mean
2583836|NCT02362425|Other Pre-specified|Pediatric Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Pre-Intervention|Participants were asked to complete the PROMIS questionnaire through the NIH online, self-administered Clinical Trials Survey System. PROMIS scores were normed to 100 meaning that the raw scores were converted to a scale where 50 is the mean and the standard deviation is 10. Scores less than 50 indicate less fatigue compared to the average and scores over 50 indicate more fatigue than the average. Lower scores represent better outcomes.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||t score||Standard Deviation|Mean
2583837|NCT02362425|Other Pre-specified|Adult Quality of Life in Neurological Disorders (NeuroQoL) Fatigue Pre-Intervention|Participants were asked to complete the NeuroQoL questionnaire through the NIH online, self-administered Clinical Trials Survey System. The NeuroQoL scores were normed to 100, meaning that the raw score is converted to a scale where 50 is the mean and the standard deviation is 10. Scores less than 50 indicate less fatigue compared to the average and scores over 50 indicate more fatigue than the average. Lower scores represent better outcomes.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||t score||Standard Deviation|Mean
2583921|NCT02361580|Primary|Upper Extremity Disability Measured by PROMIS Upper Extremity|Upper Extremity Disability measured by PROMIS Upper Extremity|8 weeks|All of the subjects were lost to follow up in both groups.||||||
2583838|NCT02362425|Other Pre-specified|Adult Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue Pre-Intervention|Participants were asked to complete the PROMIS (patient-reported outcomes measurement information system) through the NIH online, self-administered Clinical Trials Survey System. PROMIS scores are normed to 100 meaning that the raw score is converted to a scale where 50 is the mean and the standard deviation is 10. Scores less than 50 indicate less fatigue compared to the average and scores over 50 indicate more fatigue than the average. Lower scores represent better outcomes.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||t score||Standard Deviation|Mean
2583839|NCT02362425|Other Pre-specified|Peak Torque Extension Pre-Intervention|Lower-body isometric strength testing was used to determine peak torque during flexion and extension. Participant's blood pressure was assessed, to rule-out hypertension (>140/90), prior to starting the test. Participants were then asked to push against a stationary arm and remained at the same joint angle for the duration of each test. Two short trials were completed to establish maximal force for each participant. This was followed by a long trial of flexion and extension to capture rate of fatigue to 50% after reaching their pre-determined maximal force. In the interest of safety, participants with hypertension and/or a history of knee injury did not perform the test.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||nM||Standard Deviation|Mean
2583840|NCT02362425|Other Pre-specified|Peak Torque Flexion Pre-Intervention|Lower-body isometric strength testing was used to determine peak torque during flexion and extension. Participant's blood pressure was assessed, to rule-out hypertension (>140/90), prior to starting the test. Participants were then asked to push against a stationary arm and remained at the same joint angle for the duration of each test. Two short trials were completed to establish maximal force for each participant. This was followed by a long trial of flexion and extension to capture rate of fatigue to 50% after reaching their pre-determined maximal force. In the interest of safety, participants with hypertension and/or a history of knee injury did not perform the test.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||nM||Standard Deviation|Mean
2583841|NCT02362425|Other Pre-specified|Hand Pinch Strength Pre-Intervention|Grip and pinch strength were determined using Myotools dynamometry. The myopinch pinch gauge was used to measure finger strength. Higher scores represent better outcomes.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||kg||Standard Deviation|Mean
2583842|NCT02362425|Other Pre-specified|Hand Grip Strength Pre-Intervention|Grip and pinch strength were determined using Myotools dynamometry. The myogrip hand held dynamometer was used to assess grip strength. Higher scores represent better outcomes.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||kg||Standard Deviation|Mean
2583843|NCT02362425|Other Pre-specified|Motor Function Measure-32 (MFM-32) Total Score Pre-Intervention|Motor Function Measure, MFM-32 is a well-established scale of motor function in congenital muscle disease. Generic Values for each domain are: 0 = cannot perform the task, 1 = initiated the task, 2 - performs the movement incompletely, or completely but imperfectly, 3 = performs the task fully and 'normally'. The total score is the sum of all the MFM-32 domains, divided by maximum score possible (96) and multiplied by 100. Min = 0, Max = 100. Lower numbers on the scale represent a worse outcome.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||% of maximum score||Standard Deviation|Mean
2583844|NCT02362425|Other Pre-specified|Motor Function Measure-32 (MFM-32) Domain 3 (D3) Pre-Intervention|Motor Function Measure, MFM-32 is a well-established scale of motor function in congenital muscle disease. The D3 domains measure distal motor function and consist of 7 items. Generic Values for each domain are: 0 = cannot perform the task, 1 = initiated the task, 2 - performs the movement incompletely, or completely but imperfectly, 3 = performs the task fully and 'normally'. The total score is the sum of all the MFM-32 domains for D3, divided by maximum score possible and multiplied by 100. Min = 0, Max = 100. Lower numbers on the scale represent a worse outcome.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||% of maximum score||Standard Deviation|Mean
2583845|NCT02362425|Other Pre-specified|Motor Function Measure-32 (MFM-32) Domain 2 (D2) Pre-Intervention|Motor Function Measure, MFM-32 is a well-established scale of motor function in congenital muscle disease. The D2 domains measure axial and proximal motor function and consists of 12 items. Generic Values for each domain are: 0 = cannot perform the task, 1 = initiated the task, 2 - performs the movement incompletely, or completely but imperfectly, 3 = performs the task fully and 'normally'. The total score is the sum of all the MFM-32 domains for D2, divided by maximum score possible and multiplied by 100. Min = 0, Max = 100. Lower numbers on the scale represent a worse outcome.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis..|||% of maximum score||Standard Deviation|Mean
2583885|NCT02362412|Secondary|Clinical Global Impression-Bipolar-Change (CGI-BP-C):Overall Bipolar Illness|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)|||Units on a scale||95% Confidence Interval|Least Squares Mean
2583846|NCT02362425|Other Pre-specified|Motor Function Measure-32 (MFM-32) Domain 1 (D1) Pre-Intervention|Motor Function Measure, MFM-32 is a well-established scale of motor function in congenital muscle disease. The D1 domains measure standard and transfers, and consist of 13 items. Generic Values for each domain are: 0 = cannot perform the task, 1 = initiated the task, 2 - performs the movement incompletely, or completely but imperfectly, 3 = performs the task fully and 'normally'. Total score is the sum of all the domains for D1 divided by the maximum score possible and multiplied by 100. Min=0, Max = 100. Lower numbers on the scale represent a worse outcome.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||% of maximum score||Standard Deviation|Mean
2583847|NCT02362425|Other Pre-specified|Supine to Stand Pre-Intervention|Participants completed the following timed function tests: supine to stand, ascend four steps, descend four steps, and walk/run 10 meters. For time taken to transition from supine to standing, participants were asked to lay supine and then the time taken to move from supine to standing was recorded.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||seconds||Standard Deviation|Mean
2583848|NCT02362425|Other Pre-specified|Walk/Run 10 Meters Pre-Intervention|Participants completed the following timed function tests: supine to stand, ascend four steps, descend four steps, and walk/run 10 meters. For walk/run 10 meters, participants were timed as they walked/ran a marked 10-meter course as quickly as possible.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||seconds||Standard Deviation|Mean
2583849|NCT02362425|Other Pre-specified|Descend Steps Pre-Intervention|Participants completed the following timed function tests: supine to stand, ascend four steps, descend four steps, and walk/run 10 meters. For time taken to descend four steps, the subject was asked to descend four steps whilst being timed.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||seconds||Standard Deviation|Mean
2583850|NCT02362425|Other Pre-specified|Time to Ascend Steps (Seconds) Pre-Intervention|Participants completed the following timed function tests: supine to stand, ascend four steps, descend four steps, and walk/run 10 meters. For time taken to ascend four steps, the subject was asked to ascend four steps whilst being timed.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||seconds||Standard Deviation|Mean
2583851|NCT02362425|Other Pre-specified|DCF-fluorescence Intensity (AU) Pre-Intervention|Dichlorodihydrofluorescein (DCFH) will be used on participate muscle biopsies to analyze intracellular oxidant activity [H2DCFDA (H2-DCF, DCF)].|6 months|This analysis was performed only on participants in the randomized population who volunteered to have the muscle biopsy performed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||AU||Standard Deviation|Mean
2583852|NCT02362425|Other Pre-specified|Six Minute Walk Test (6MWT) Pre-Intervention|Meters walked in 6 minutes will be recorded; distances in meters will be recorded at each minute interval; speed will be calculated.|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||meters||Standard Deviation|Mean
2583853|NCT02362425|Other Pre-specified|Urine 15-F2t Isoprostane Concentration Pre-Intervention|Urine will be assayed for 15-isoprostane-F2, which is formed when arachidonic acid reacts with reactive oxygen species(ROS). A validated gas chromatography(GC)-mass spectrometer (MS) method will be used to quantify 15-isoprostane-F2|6 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers post baseline, thus they are not included in this analysis..|||ng/mg Cr||Standard Deviation|Mean
2583854|NCT02362425|Secondary|Blood Glutathione Reduced (GSH):Oxidized (GSSG) Ratio|GSH:GSSG ratio analyzed only at baseline to offer comparison of RYR1-RM affected individuals to the general population.|Baseline||||ratio||Standard Deviation|Mean
2583855|NCT02362425|Secondary|Pediatric Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score|Pediatric participants (< 18 years) were asked to complete the Peds-FACIT-F questionnaire through the NIH online, self-administered Clinical Trials Survey System.Minimum value = 0, maximum value = 52. Higher scores represent a better outcome/ better QOL.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2583856|NCT02362425|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Trial Outcome Index|Participants were asked to complete the FACIT-F questionnaire through the NIH online, self-administered Clinical Trials Survey System. The Trial Outcome Index (TOI) is the sum of the physical well-being, functional well-being and 'additional concerns' subscales. The minimum value = 0, and maximum value = 52. Scores under 30 is considered to be severe fatigue. Higher scores represent a better outcome/QOL.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2583886|NCT02362412|Secondary|Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Mania|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill)|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)|||Units on a scale||Standard Deviation|Mean
2583857|NCT02362425|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score|Participants were asked to complete the FACIT-f questionnaire through the NIH online, self-administered Clinical Trials Survey System. Minimum value = 0, maximum value = 160. Higher scores represent a better outcome/ better QOL.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2583858|NCT02362425|Secondary|Multidimensional Fatigue Inventory-20 (MFI-20) Mental Fatigue Score|Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2583859|NCT02362425|Secondary|Multidimensional Fatigue Inventory-20 (MFI-20) Reduced Motivation Score|Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2583860|NCT02362425|Secondary|Multidimensional Fatigue Inventory-20 (MFI-20) Reduced Activity Score|Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2583861|NCT02362425|Secondary|Multidimensional Fatigue Inventory-20 (MFI-20) Physical Fatigue Score|Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2583862|NCT02362425|Secondary|Multidimensional Fatigue Inventory - 20 (MFI-20) General Fatigue Score|Participants were asked to complete the MFI-20 questionnaire through the NIH online, self-administered Clinical Trials Survey System. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Values range from 4-20 for each scale. Higher scores represent increased fatigue/ worse outcome.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2583863|NCT02362425|Secondary|Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Fatigue|Participants were asked to complete the NeuroQoL questionnaire through the NIH online, self-administered Clinical Trials Survey System. NeuroQoL scores were normed to 100 meaning that the raw score is converted to a scale where 50 is the mean and the standard deviation is 10. Scores less than 50 indicate less fatigue compared to the average and scores over 50 indicate more fatigue than the average. Lower scores represent better outcomes.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||t score||95% Confidence Interval|Least Squares Mean
2583864|NCT02362425|Secondary|Pediatric Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue|Participants were asked to complete the PROMIS questionnaire through the NIH online, self-administered Clinical Trials Survey System. PROMIS scores were normed to 100 meaning that the raw scores were converted to a scale where 50 is the mean and the standard deviation is 10. Scores less than 50 indicate less fatigue compared to the average and scores over 50 indicate more fatigue than the average. Lower scores represent better outcomes.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||t score||95% Confidence Interval|Least Squares Mean
2583865|NCT02362425|Secondary|Adult Quality of Life in Neurological Disorders (NeuroQoL) Fatigue|Participants were asked to complete the NeuroQoL questionnaire through the NIH online, self-administered Clinical Trials Survey System. The NeuroQoL scores were normed to 100, meaning that the raw score is converted to a scale where 50 is the mean and the standard deviation is 10. Scores less than 50 indicate less fatigue compared to the average and scores over 50 indicate more fatigue than the average. Lower scores represent better outcomes.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||t score||95% Confidence Interval|Least Squares Mean
2583922|NCT02361476|Secondary|Adverse Events||from intervention to discharge from the recovery room||||participants|||Number
2583923|NCT02361476|Secondary|First Administration of Fentanyl or Morphine|Time to administration|recovery room||||MEDIAN time (min) to administration||Standard Deviation|Median
2583866|NCT02362425|Secondary|Adult Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue|Participants were asked to complete the PROMIS (patient-reported outcomes measurement information system) through the NIH online, self-administered Clinical Trials Survey System. PROMIS scores are normed to 100 meaning that the raw score is converted to a scale where 50 is the mean and the standard deviation is 10. Scores less than 50 indicate less fatigue compared to the average and scores over 50 indicate more fatigue than the average. Lower scores represent better outcomes.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||t score||95% Confidence Interval|Least Squares Mean
2583867|NCT02362425|Secondary|Peak Torque Extension|Lower-body isometric strength testing was used to determine peak torque during flexion and extension. Participant's blood pressure was assessed, to rule-out hypertension (>140/90), prior to starting the test. Participants were then asked to push against a stationary arm and remained at the same joint angle for the duration of each test. Two short trials were completed to establish maximal force for each participant. This was followed by a long trial of flexion and extension to capture rate of fatigue to 50% after reaching their pre-determined maximal force. In the interest of safety, participants with hypertension and/or a history of knee injury did not perform the test.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||nM||95% Confidence Interval|Least Squares Mean
2583868|NCT02362425|Secondary|Peak Torque Flexion|Lower-body isometric strength testing was used to determine peak torque during flexion and extension. Participant's blood pressure was assessed, to rule-out hypertension (>140/90), prior to starting the test. Participants were then asked to push against a stationary arm and remained at the same joint angle for the duration of each test. Two short trials were completed to establish maximal force for each participant. This was followed by a long trial of flexion and extension to capture rate of fatigue to 50% after reaching their pre-determined maximal force. In the interest of safety, participants with hypertension and/or a history of knee injury did not perform the test.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||nM||95% Confidence Interval|Least Squares Mean
2583869|NCT02362425|Secondary|Hand Pinch Strength|Grip and pinch strength were determined using Myotools dynamometry. The myopinch pinch gauge was used to measure finger strength. Higher scores represent better outcomes.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||kg||95% Confidence Interval|Least Squares Mean
2583870|NCT02362425|Secondary|Hand Grip Strength|Grip and pinch strength were determined using Myotools dynamometry. The myogrip hand held dynamometer was used to assess grip strength. Higher scores represent better outcomes.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||kg||95% Confidence Interval|Least Squares Mean
2583871|NCT02362425|Secondary|Motor Function Measure-32 (MFM-32) Total Score|Motor Function Measure, MFM-32 is a well-established scale of motor function in congenital muscle disease. Generic Values for each domain are: 0 = cannot perform the task, 1 = initiated the task, 2 - performs the movement incompletely, or completely but imperfectly, 3 = performs the task fully and 'normally'. The total score is the sum of all the MFM-32 domains, divided by maximum score possible (96) and multiplied by 100. Min = 0, Max = 100. Lower numbers on the scale represent a worse outcome.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||% of maximum score||95% Confidence Interval|Least Squares Mean
2583872|NCT02362425|Secondary|Motor Function Measure-32 (MFM-32) Domain 3 (D3)|Motor Function Measure, MFM-32 is a well-established scale of motor function in congenital muscle disease. The D3 domains measure distal motor function and consist of 7 items. Generic Values for each domain are: 0 = cannot perform the task, 1 = initiated the task, 2 - performs the movement incompletely, or completely but imperfectly, 3 = performs the task fully and 'normally'. The total score is the sum of all the MFM-32 domains for D3, divided by maximum score possible and multiplied by 100. Min = 0, Max = 100. Lower numbers on the scale represent a worse outcome.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||% of maximum score||95% Confidence Interval|Least Squares Mean
2583873|NCT02362425|Secondary|Motor Function Measure-32 (MFM-32) Domain 2 (D2)|Motor Function Measure, MFM-32 is a well-established scale of motor function in congenital muscle disease. The D2 domains measure axial and proximal motor function and consists of 12 items. Generic Values for each domain are: 0 = cannot perform the task, 1 = initiated the task, 2 - performs the movement incompletely, or completely but imperfectly, 3 = performs the task fully and 'normally'. The total score is the sum of all the MFM-32 domains for D2, divided by maximum score possible and multiplied by 100. Min = 0, Max = 100. Lower numbers on the scale represent a worse outcome.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||% of maximum score||95% Confidence Interval|Least Squares Mean
2583887|NCT02362412|Secondary|Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S):Depression|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill).|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)|||Units on a scale||95% Confidence Interval|Least Squares Mean
2605718|NCT02107014|Primary|Change in VEGF-D From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2583874|NCT02362425|Secondary|Motor Function Measure-32 (MFM-32) Domain 1 (D1)|Motor Function Measure, MFM-32 is a well-established scale of motor function in congenital muscle disease. The D1 domains measure standard and transfers, and consist of 13 items. Generic Values for each domain are: 0 = cannot perform the task, 1 = initiated the task, 2 - performs the movement incompletely, or completely but imperfectly, 3 = performs the task fully and 'normally'. Total score is the sum of all the domains for D1 divided by the maximum score possible and multiplied by 100. Min=0, Max = 100. Lower numbers on the scale represent a worse outcome.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||% of maximum score||95% Confidence Interval|Least Squares Mean
2583875|NCT02362425|Secondary|Supine to Stand|Participants completed the following timed function tests: supine to stand, ascend four steps, descend four steps, and walk/run 10 meters. For time taken to transition from supine to standing, participants were asked to lay supine and then the time taken to move from supine to standing was recorded.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||seconds||95% Confidence Interval|Least Squares Mean
2583876|NCT02362425|Secondary|Walk/Run 10 Meters|Participants completed the following timed function tests: supine to stand, ascend four steps, descend four steps, and walk/run 10 meters. For walk/run 10 meters, participants were timed as they walked/ran a marked 10-meter course as quickly as possible.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||seconds||95% Confidence Interval|Least Squares Mean
2583877|NCT02362425|Secondary|Descend Steps|Participants completed the following timed function tests: supine to stand, ascend four steps, descend four steps, and walk/run 10 meters. For time taken to descend four steps, the subject was asked to descend four steps whilst being timed.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||seconds||95% Confidence Interval|Least Squares Mean
2583878|NCT02362425|Secondary|Time to Ascend Steps (Seconds)|Participants completed the following timed function tests: supine to stand, ascend four steps, descend four steps, and walk/run 10 meters. For time taken to ascend four steps, the subject was asked to ascend four steps whilst being timed.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||seconds||95% Confidence Interval|Least Squares Mean
2583879|NCT02362425|Secondary|DCF-fluorescence Intensity (AU)|Dichlorodihydrofluorescein (DCFH) will be used on participate muscle biopsies to analyze intracellular oxidant activity [H2DCFDA (H2-DCF, DCF)].|12 months|This analysis was performed only on participants in the randomized population who volunteered to have the muscle biopsy performed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||AU||95% Confidence Interval|Mean
2583880|NCT02362425|Primary|Six Minute Walk Test (6MWT)|Meters walked in 6 minutes will be recorded; distances in meters will be recorded at each minute interval; speed will be calculated.|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers, thus they are not included in this analysis.|||meters||95% Confidence Interval|Least Squares Mean
2583881|NCT02362425|Primary|Urine 15-F2t Isoprostane Concentration|Urine will be assayed for 15-isoprostane-F2, which is formed when arachidonic acid reacts with reactive oxygen species(ROS). A validated gas chromatography(GC)-mass spectrometer (MS) method will be used to quantify 15-isoprostane-F2|12 months|Outcome measures are reported for participants who were randomized and continued into the randomized, double-blind period of the trial. Missing data was not imputed. This measure was not collected for Healthy Volunteers post-baseline (months 6 and 12), thus they are not included in the analysis.|||ng/mg Cr||95% Confidence Interval|Least Squares Mean
2583882|NCT02362412|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any undesirable or unintended sign (including abnonmal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important.|Up to 22 weeks|Safety Analysis Set (SAF), which included participants who received at least one dose of study drug.|||Participants|||Number
2583883|NCT02362412|Secondary|Clinical Global Impression-Bipolar-Change (CGI-BP-C):Mania|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)|||Units on a scale||Standard Deviation|Mean
2583884|NCT02362412|Secondary|Clinical Global Impression-Bipolar-Change (CGI-BP-C):Depression|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)|||Units on a scale||95% Confidence Interval|Least Squares Mean
2583888|NCT02362412|Secondary|Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill).|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)|||Units on a scale||95% Confidence Interval|Least Squares Mean
2583889|NCT02362412|Secondary|Hamilton Depression Scale (HAM-D17)|The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52 with lower scores indicating less depressive symptoms.|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)|||Units on a scale||95% Confidence Interval|Least Squares Mean
2583890|NCT02362412|Primary|Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.|Week 8 of each treatment period (Week 12 and Week 20)|Full Analysis Set (FAS)|||UNITS ON A SCALE||95% Confidence Interval|Least Squares Mean
2583891|NCT02362373|Secondary|Number of Participants Continuing With IUD|Women continuing the IUD for contraception at 6 months|6 months||||participants|||Number
2583892|NCT02362373|Secondary|Change in Seizure Frequency|Number of participants with increased, unchanged or decreased mean monthly seizure frequency.|baseline to 6 months||||participants|||Number
2583893|NCT02362373|Primary|Percent of Participants That Experienced Clinically Meaningful Change in Oxcarbazepine Level|The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of oxcarbazepine after IUD insertion.|from baseline to 6 months after LNG IUS insertion|3 out of 20 participants received oxcarbazepine while on IUD.|||percentage of participants|||Number
2583894|NCT02362373|Primary|Percent of Participants That Experienced Clinically Meaningful Change in Levetiracetam Level|The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of levetiracetam after IUD insertion.|from baseline to 6 months after LNG IUS insertion|5 out of 20 participants received levetiracetam while on IUD.|||percentage of participants|||Number
2583895|NCT02362373|Primary|Percent of Participants That Experienced Clinically Meaningful Change in Lamotrigine Level|The outcome measure is designed to examine whether participants will experience subtherapeutic or toxic serum trough level of lamotrigine after IUD insertion.|from baseline to 6 months after LNG IUS insertion|13 out of 20 participants received lamotrigine while on IUD.|||percentage of participants|||Number
2583896|NCT02362360|Primary|"Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From Very Poor to Very Good."|"Subjects will evaluate the fit to body for each product by answering the question How was the baseplates ability to fit to the body contours in the area around the stoma?. The question is answered with a 5-point scale ranging from very poor to very good."|21 +/- 3 days||||percentage of subjects answering|||Number
2583897|NCT02362321|Primary|Rate of Need for Surgery Drainage|The rate of success of conservative management was defined as the number of patients not requiring surgery in each treatment group during the 6 months following enrollment.|Within 6 months||||participants|||Number
2583898|NCT02362282|Primary|Change in the Gait Assessment and Intervention (G.A.I.T.) Score|Coordination of walking, scored using the investigators' novel G.A.I.T. measure. This measure evaluated limb and joint movements while participants walk overground at preferred speed. Range of scale: 0 (normal) to 64 (extremely discoordinated gait).|pre-training (0 weeks), post training (about 12 weeks)|Adults with chronic post-stroke hemiparesis and gait deficits|||units on a scale||Standard Deviation|Mean
2583899|NCT02362048|Primary|Number of Participants With Overall Response Advanced or Metastatic Pancreatic Cancer.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Every 12 weeks for up to 2 years.|All participants with Baseline and at least one post-baseline target lesion measurement.|||Participants|||Count of Participants
2583900|NCT02361762|Secondary|Event-related Potentials Assessed During Cued Go/Nogo Task|"Conflict Processing-ERP Brain Response (N2 mean amplitude) Data were compared for Go and Nogo conditions at each time point (baseline and post testing).~The task included 200 test trials. During 'go' trials (70% of trials), children were instructed to press a single button on a keypad each time a letter appeared on the screen. During 'nogo' trials (30% of trials), children were instructed to withhold their response when a specific letter appeared on the screen. To account for the confound of frequency with condition, two letters were used for go trials - an infrequent go (30% of trials) and a frequent go (40% of trials). Go responses were analyzed only for the infrequent go trials. Each trial was preceded by a fixation cross presented on the screen for 500 ms. Test trials were then presented for 700 ms. Only ERPs for correct trials that followed a correct 'go' response were analyzed in order to ensure consistent motor response on the previous trial."|Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)|This task was always administered after the Child ANT Flanker Task, resulting in fewer children who completed it at both time points. Of the 68 children who returned for post-testing, 30 provided usable, artifact free data at both time points.|||microvolts||Standard Deviation|Mean
2583901|NCT02361762|Secondary|Performance on Hungry Donkey Task Assessed as Ratio of Safe to Risky Selections|Conflict Processing (Reward) Behavior (Post-testing controlling for Baseline). Children selected from four doors with varying reward and loss ratios. Two doors have lower rewards but an overall net gain (safe) and two doors have higher rewards but an overall net loss (risky). Scores represent the ratio of safe to risky selections in the final two blocks (of five total blocks administered).|Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)|Of the 68 children who completed post-testing, 64 completed the task at both time points.|||ratio of safe to risky selections||Standard Deviation|Mean
2583902|NCT02361762|Secondary|Narrative Language Task|Social Communication Ability Behavior (Post-testing controlling for Baseline). A measure of generalization.|Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)|Data were not collected.||||||
2583912|NCT02361736|Secondary|Ratio of the Urine Trace Albumin and Creatinine(ACR) on 5 Time Point|ACR is calculated by the urine trace albumin divided by the urine creatinine|-1d, 0d, 1d, 3d, 5d after surgery||||ratio||Standard Deviation|Mean
2583913|NCT02361736|Primary|Concentration of NGAL in Plasma on 5 Time Point.|concentration of NGAL in plasma on 5 time point. Biomarkers are measured by ELISA.|-1d, 0d, 1d, 3d, 5d after surgery||||ng/ml||Standard Deviation|Mean
2583903|NCT02361762|Secondary|Social Skills Improvement System-Parent (SSIS) - Social Standard Score|"Social function home (Post-testing controlling for Baseline). A measure of generalization. Scores were available from parents. The SSIS Social Scale organizes prosocial behaviors into seven areas or subscales: Communication, Cooperation, Assertion, Responsibility, Empathy, Engagement, and Self-Control. Scores range from 40-160. Higher scores reflect more prosocial skills (i.e., better social ability). At Post, higher scores represent a better outcome.~Note: Teacher SSIS was originally planned as an outcome measure, but due to low teacher response the results were not analyzed."|Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)|Of the 68 children who returned for post testing, 62 parents completed the SSIS questionnaire at both time points.|||scores on a scale||Standard Deviation|Mean
2583904|NCT02361762|Secondary|TOM Test (Theory of Mind Test)|Theory of Mind Behavior (Post-testing controlling for Baseline). A measure of generalization. Overall percent correct across the three sub-scales (i.e., percent correct calculated across all items of Level 1-Precursors, Level 2-First Order False Belief, and Level 3-Advanced) is reported. The percent correct ranges from 0-100% correct. Higher scores represent better theory of mind (affective and first/second order false belief).|Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)|Of the 68 children who returned for post testing, 67 had sufficient time to complete the TOM Test at both time points.|||percentage of correct responses||Standard Deviation|Mean
2583905|NCT02361762|Secondary|Theory of Mind Composite: Perception Knowledge, Location Change False Belief, Unexpected-contents False Belief|Theory of Mind (TOM) Behavior (Post-testing controlling for Baseline) A measure of generalization Composite score by computing the percent correct (range = 0-100% correct) across three video tasks measuring cognitive aspects of theory of mind (i.e., the Perception Knowledge Task, Location Change False Belief Task, and Unexpected-contents False Belief Task). Higher scores represent better performance (i.e., more correct responses). Higher scores at post testing represent better outcomes.|Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)|Of the 68 children who returned for post testing, 60 children had sufficient time during visits at both time points to complete these video tasks.|||percentage of correct responses||Standard Deviation|Mean
2583906|NCT02361762|Secondary|Social Attribution Task (SAT) - Problem Solving Scale|Theory of Mind Behavior (Post-testing controlling for Baseline) A measure of generalization.|Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)|Of the 68 children who returned for post testing, 49 children had sufficient time during visits at both time points for this task.|||percent correct on SAT problem solving||Standard Deviation|Mean
2583907|NCT02361762|Secondary|Backward Digit Span (Scaled Score)|"Working Memory Behavior (Post-testing controlling for Baseline) A control task - not specifically targeted by intervention. Scaled score for Backward Digit Span (higher scores represent better memory).~Scaled scores are reported (range = 1-19). Higher scores reflect better working memory (an aspect of executive function). At Post, higher scores represent a better outcome."|Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)|Of the 68 children who completed post testing, 62 provided data at both time points.|||scores on a scale||Standard Deviation|Mean
2583908|NCT02361762|Primary|BRIEF Parent Survey (Global Executive Composite)|"Executive Control at home/school-Generalization (Post-testing controlling for Baseline) Global Executive Composite (GEC) scores are available for parents. The GEC is comprised of two sub-scales: Metacognition and Behavioral Regulation.~T-scores are reported for the GEC (range = 30-100). Higher scores reflect more difficulty with executive function. At Post, lower scores represent a better outcome.~Note: Teacher BRIEF was originally planned as an outcome measure, but due to low teacher response (10 teachers provided data for each group at both time points) the results were not analyzed."|Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)|63 parents completed the questionnaire at both time points.|||scores on a scale||Standard Deviation|Mean
2583909|NCT02361762|Primary|Event-related Potentials Assessed During Child Attention Network Flanker Task|"Conflict Processing-Event Related Potential (ERP) Brain Response (N2 mean amplitude) Data were compared for congruent and incongruent conditions at each time point (baseline and post testing).~Each trial of the task began with a beep for 150ms paired with a fixation cross for 450ms at the center of the screen. Then, a target and flankers were presented for 2000ms. Congruent trials (50%) consisted of a central target animal flanked by two animals on each side with the same orientation and size as the target. Incongruent trials (50%) were identical except that the target and flankers faced opposite directions. Children pressed a button indicating the direction the target animal faced (50% left, 50% right) and received visual and auditory feedback upon responding."|Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)||||microvolts||Standard Deviation|Mean
2583910|NCT02361762|Primary|Stroop Task (Difference in Percentage of Correct Responses for Congruent Minus Incongruent Trials)|Conflict Processing-Behavior (Post-testing controlling for Baseline) Trials were presented in three conditions: (1) congruent trials (25%); (2) incongruent trials (25%); and (3) neutral trials (50%). The difference between percent correct for congruent and incongruent conditions was the dependent variable, such that larger differences indicated more difficulty with conflicting information. Lower scores at Post-testing indicate improved ability to suppress interfering/conflicting information.|Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)|Data were available for 63 children; five children were unable to complete the task or refused to play (3 baseline, 2 at post).|||difference in % of correct responses||Standard Deviation|Mean
2583911|NCT02361762|Primary|Change Task - Inhibition Function|"Conflict Processing-Behavior (Post-testing controlling for Baseline) Children indicate the location of a picture by pressing the left and right arrow buttons for 75% of the trials (i.e., the dominant task).~For the remaining 25% of trials, a stop signal appears and a Change response (i.e., space bar) was required. Stop signals occurred equally at 50, 200, 350, and 500 ms before the anticipated response based on the child's reaction time.~The inhibition function estimates the latency of inhibitory responding without adjusting for the reaction time during dominant task. Lower scores indicate more rapid inhibition."|Baseline (Pre Training/Waitlist Phase) and at 11-12 Weeks (Post Training/Waitlist Phase)|Of the 68 children randomized who returned for post testing, data were available for 62 across both time points; one participant was unable to map the correct buttons at baseline, one participant refused the task at both time points, and computer failure occurred for four participants (3 at baseline, 1 at post testing).|||miliseconds||Standard Deviation|Mean
2583924|NCT02361476|Secondary|Pain Assessment|"Pain score used:~FLACC score = Face, Legs, Activity, Cry, Consolability Score ranges from 0 to 10 (severity increases with increasing score) Pain is FLACC score more than 3"|recovery room - hours||||Pain Score||Standard Deviation|Mean
2583925|NCT02361476|Secondary|Fentanyl and Morphine Requirements|Amount used|Recorded during the stay in the postoperative recovery room||||mg morphine equivalents||Standard Deviation|Mean
2583926|NCT02361476|Primary|Postoperative Agitation|Measured by Watchae Scale (score 1-4), scores 1-2 = no agitation and scores 3-4 = agitated|1 day|9 were excluded in the primary outcome due to missing data points|||participants with agitation|||Number
2583927|NCT02361216|Secondary|Percent Reduction From Baseline in AK Count|Percent reduction in AK count in the selected treatment area at Week 8|8 weeks|Percent reduction in AK count is based on the full analysis set (FAS)|||percentage reduction of AK count||95% Confidence Interval|Mean
2583928|NCT02361216|Secondary|Percentage of Participants With Partial Clearance at Week 4|Partial clearance (AKclear75) defined as a reduction in the number of clinically visible AKs in the selected treatment area by at least 75% compared to baseline.|4 weeks|AKclear75 at Week 4 is based on the full analysis set (FAS)|||percentage of participants|||Number
2583929|NCT02361216|Secondary|Percentage of Participants With Partial Clearance at Week 8|Partial clearance (AKclear75 ) is defined as a reduction in the number of clinically visible AKs in the selected treatment area by at least 75% compared to baseline.|8 weeks|AKclear75 at Week 8 is based on the full analysis set (FAS)|||percentage of participants|||Number
2583930|NCT02361216|Primary|Percentage of Participants With Complete Resolution of Actinic Keratosis (AK)|Complete resolution of actinic keratosis (AKclear100) at Week 8 is defined as 100% reduction from baseline in the number of clinically visible AKs|8 weeks|Of the 729 subjects randomised to treatment, 4 did not receive treatment. These 4 subjects (3 subjects in active treatment group and 1 in vehicle group) were excluded from the Full Analysis Set (FAS), which consisted of 725 subjects (549 subjects in active treatment group and 176 in corresponding vehicle group). AKclear100 is based on the FAS|||percentage of participants|||Number
2583931|NCT02360995|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 weeks||||units on a scale||Standard Error|Mean
2583932|NCT02360995|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|4 weeks||||units on a scale||Standard Error|Mean
2583933|NCT02360995|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|Baseline||||units on a scale||Standard Deviation|Mean
2583934|NCT02360995|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 weeks||||units on a scale||Standard Error|Mean
2583935|NCT02360995|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|4 weeks||||units on a scale||Standard Error|Mean
2583936|NCT02360995|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Baseline||||units on a scale||Standard Deviation|Mean
2583937|NCT02360774|Secondary|Change in Glycemic Control|Hemoglobin A1C will be measured at baseline and at study completion.|18 weeks (duration of study)||||percent glycated hemoglobin||Standard Error|Mean
2583938|NCT02360774|Secondary|Change in Body Composition, Measured Using DXA Scanning.|Body composition will be measured at baseline and at study completion using DXA scanning.|18 weeks (duration of study)||||% fat||Standard Error|Mean
2583939|NCT02360774|Secondary|Change in Resting Energy Expenditure, Measured Using Indirect Calorimetery|Resting energy expenditure will be measured at each study visit using indirect calorimetery. Data analysis will include change in REE from baseline to study conclusion, as well as change in REE throughout the study.|18 weeks (duration of study)||||kcal||Standard Error|Mean
2583940|NCT02360774|Primary|Change in Body Weight|Body weight will be measured at each study visit (screening visit, enrollment (study week 0), and at study weeks 2, 4, 8, 12 and 18). Change in body weight will be calculated using ANOVA such that body weight at all time points is included in the data analysis, rather than simply comparing weight at the enrollment visit to weight at the final study visit.|18 weeks (duration of study)||||kg||Standard Error|Mean
2583941|NCT02360631|Secondary|Number of Participants With Smoking Abstinence at Week 26|Intent to treat Cotinine verified cessation for light and moderate to heavy smokers by treatment|Week 26|300 participants received varenicline and of those 154 were Light smokers (10 or less cigarettes per day (CPD) and 146 were moderate to heavy smokers (greater than 10 )CPD. 200 participants received placebo medication and of those 106 were light smokers and 94 were moderate to heavy smokers.|||Participants|||Count of Participants
2583942|NCT02360631|Secondary|Number of Participants With Smoking Abstinence at Week 12|Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Week 12 visit|Week 12||||Participants|||Count of Participants
2596360|NCT02209766|Secondary|AUC(0-tau) in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2583943|NCT02360631|Primary|Number of Participants With Smoking Abstinence at Month 6|Biochemically verified 7-day point prevalence abstinence defined as smoking zero cigarettes at Month 6 visit|Month 6||||Participants|||Count of Participants
2583944|NCT02360488|Primary|Change in Arm Motor Fugl-Meyer Score From Baseline to 30 Days Post-therapy|The full name of this scale is the arm motor Fugl-Meyer scale. it measures arm motor impairment, which is in the body structure/function domain. It consists of 33 individual assessments that are summed to generate a total arm motor Fugl-Meyer score. Scores range from 0-66, which higher values being better (and so 66 being normal). There are no subscores evaluated.|from the Baseline Visit to the 30 Day Follow Up Visit|Intention-to-Treat with multiple imputation of missing outcomes|||units on a scale||Standard Deviation|Mean
2583945|NCT02360475|Secondary|Number of Subjects With SAEs|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to study end at Day 360|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented.|||Participants|||Count of Participants
2583946|NCT02360475|Secondary|Concentrations of PCA|PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).|At Day 90 post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.|||µg/mL||95% Confidence Interval|Geometric Mean
2583947|NCT02360475|Secondary|Concentrations of PCA|PCA concentrations, expressed as Geometric Mean Concentrations (GMCs).The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).|At Day 60 post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.|||µg/mL||95% Confidence Interval|Geometric Mean
2583948|NCT02360475|Secondary|Concentrations of PCA|PCA concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).|At Day 30 post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.|||µg/mL||95% Confidence Interval|Geometric Mean
2583949|NCT02360475|Secondary|Concentrations of Palivizumab Competing Antibodies (PCA)|Palivizumab competing antibody concentrations, expressed as Geometric Mean Concentrations (GMCs). The assay cut-off was greater than or equal to 3.34 micrograms per millilitre (µg/mL).|At Day 0 pre-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.|||µg/mL||95% Confidence Interval|Geometric Mean
2583950|NCT02360475|Secondary|Titres of RSV-A Neutralizing Antibodies|RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60).|At Day 90 post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.|||Titres||95% Confidence Interval|Geometric Mean
2583951|NCT02360475|Secondary|Titres of RSV-A Neutralizing Antibodies|RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were defined as any titre greater than or equal to (≥) the cut-off 8 serum dilution inducing 60 % inhibition in plaque forming units (ED60).|At Day 60 post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.|||Titres||95% Confidence Interval|Geometric Mean
2583952|NCT02360475|Primary|Titres of RSV-A Neutralizing Antibodies|RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).|At Day 30 post-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.|||Titres||95% Confidence Interval|Geometric Mean
2583953|NCT02360475|Primary|Titres of RSV-A Neutralizing Antibodies|RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).|At Day 0 pre-vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which consisted of all subjects from the Total Vaccinated cohort who complied with eligibility criteria, received the study vaccine according to study procedures and had immunogenicity results in the epoch.|||Titres||95% Confidence Interval|Geometric Mean
2583954|NCT02360475|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From vaccination at Day 0, up to Day 30 post-vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented.|||Participants|||Count of Participants
2583969|NCT02360280|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score After 12 Days of Treatment|Average difference in the Montgomery-Asberg Depression Rating Scale (MADRS) score change between groups. The MADRS has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).|13 days||||units on a scale||95% Confidence Interval|Mean
2583955|NCT02360475|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination."|During the 30-Day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented.|||Participants|||Count of Participants
2583956|NCT02360475|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms (symp.) were headache, fever [defined as oral temperature (temp.) equal to or above 37.5 degrees Celsius (°C)], fatigue, gastrointestinal (Gastro.) symptoms [nausea, vomiting, diarrhoea and/or abdominal pain]. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 (G3) symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented and with the symptoms sheet filled in.|||Participants|||Count of Participants
2583957|NCT02360475|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 100 millimeters (mm).|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccines administration documented and with the symptoms sheet filled in.|||Participants|||Count of Participants
2583958|NCT02360397|Secondary|Number of Non-sustained Ventricular Tachycardia and Sustained Ventricular Arrhythmia Episodes on Holter Monitoring|Number of non-sustained ventricular tachycardia episodes (>8 beats) and sustained ventricular arrhythmia episodes on Holter monitoring at baseline and at 30 days|Baseline and Day 30||||number of episodes|||Number
2583959|NCT02360397|Secondary|Score on Seattle Angina Questionnaire at Baseline and at Day 30|The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life). Angina symptoms may be felt as: chest pain, a heaviness, tightness or squeezing sensation in the chest, aching across the chest, particularly behind the breastbone. The pain may radiate to the neck, jaw, arms, back or teeth.|Baseline and day 30|Score on Seattle Angina Questionnaire at Baseline and at day 30.|||score on a scale||Full Range|Mean
2583960|NCT02360397|Primary|The Effect of Ranolazine on Cardiac Ischemia|The effect of ranolazine on cardiac ischemia as measured by change in millimeters of ST segment deviation on ECG monitoring at Baseline and after 30 days of Ranolazine therapy (day 30).|Baseline and day 30||||millimeters||Full Range|Mean
2583961|NCT02360397|Primary|The Effect of Ranolazine on the PVC Burden Over 30 Days|The change in percentage of PVC burden after taking Ranolazine 1000mg twice daily for 30 days|Baseline (7 day) Holter compared to day 30 (7 day) Holter|The percentage of PVC's on Holter monitor at baseline compared to day 30 were used to determine the statistical significance of the data.|||percentage of PVC burden||Full Range|Mean
2583962|NCT02360293|Secondary|Change in Pain Measures as Assessed by the VA Pain Intensity|Pain intensity will be elicited via online survey. Neuropathic Pain in Past Week Reporting Scores on a Scale, Lower Scores Indicate a Better Outcome, Range: 0-10|Change from Baseline in Pain measures at one year after randomization|Population decreases with time, at 12-month follow-up: SS+coaching 101; SS 84.|||units on a scale||95% Confidence Interval|Least Squares Mean
2583963|NCT02360293|Secondary|Change in Depression Score as Assessed by the Personal Health Questionnaire Depression Scale (PHQ-8)|The Personal Health Questionnaire Depression Scale (PHQ) will be administered via online survey. Personal Health Questionnaire (8 item version),Reporting Scores on a Scale Lower Scores Indicate a Better Outcome, Range: 0-24|Change from Baseline Depression score at one year after randomization|Population decreases with time, at 12-month follow-up: SS+coaching 96; SS 81.|||score on a scale||95% Confidence Interval|Least Squares Mean
2583964|NCT02360293|Secondary|Change in Weight as Measured From VA Medical Record|Weights were extracted from VHA's Corporate Data Warehouse, vital signs package due to the high number of missing weights from the study provided blue tooth scale.|Change from Baseline in weight at one year after randomization|Due to missing data from study provided scale, EHR weight was pulled for all patients, however, roughly half of the population lacked EHR weights within the time-frame of the study.|||weight by pounds||95% Confidence Interval|Least Squares Mean
2583965|NCT02360293|Primary|Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device|Physical activity is measured as Active Minutes by a wearable Fitbit Charge 2 device; daily activity is averaged over a one week period for which at least 5 days of valid data are available.|Change from Baseline in objectively monitored physical activity at one year after randomization|Population decreases with time, at 12-month follow-up: SS+coaching 68; SS 58.|||Active minutes/week||95% Confidence Interval|Least Squares Mean
2583966|NCT02360280|Secondary|Time From Post-infusion Response to Occurrence of Relapse Defined as <50% of Baseline MADRS Score|The length of time from post-infusion response until relapse (defined as >50% of MADRS baseline score) assessed for up to 6 months.|6 months|The overall number of participants in each intervention corresponds to the total number of subjects that achieve response at the end of six infusions.|||weeks||95% Confidence Interval|Median
2583967|NCT02360280|Secondary|Remission Defined as MADRS Score Equal or Less Than 9|Comparing the number of subjects that achieve remission between groups as defined above|13 days||||Participants|||Count of Participants
2583968|NCT02360280|Secondary|Antidepressant Response Defined as >50% Decrease in MADRS Baseline Score|Comparing the number of subjects that achieve response between groups as defined above.|13 days||||Participants|||Count of Participants
2584517|NCT02355665|Secondary|Pulse at Week 20|Pulse (beats per minute)|Week 20|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||beats per minute||Standard Deviation|Mean
2583970|NCT02360228|Secondary|Change in Peak Frequency of Functional Connectivity From Baseline Measured With Electroencephalogram (EEG) Resting State|The investigators will compare peak frequency of functional connectivity from resting state EEG recordings on the first and last day of stimulation. The investigators will also collect EEG recordings data at the one week and one month follow up visits. The investigators will use each of the four EEG recordings as data to analyze the change in peak frequency of functional connectivity as a pilot study for derivation of EEG biomarkers.|Baseline, five days post baseline|Per protocol; All eligible participants who completed every session of the study from the initial session through the one month follow-up that followed the study protocol.|||Hertz (Hz)||Standard Deviation|Mean
2583971|NCT02360228|Other Pre-specified|Change in Electroencephalogram (EEG) Auditory Tasks: Click Train Task From Baseline|"The investigators will compare auditory responses during auditory tasks EEG recordings on the first and last day of stimulation. The investigators will also collect this data at the one week and one month follow up visits.~Auditory steady-state response (ASSR) from EEG data elicited by auditory click trains is considered as a hallmark of network dysfunction in schizophrenia. To obtain ASSR, auditory tones at a specific frequency (e.g., 40Hz) are presented for multiple trials and EEG data is analyzed to extract brain responses to the stimuli.~One common way to extract the brain responses from this task is phase coherence between trials. When external stimuli (click trains) occur, brain signals are synchronized to these stimuli and its coherence should be the highest at the stimulation frequency. Phase information for calculating the coherence can be obtained by time-frequency analysis. Averaged coherence across the multiple trials can represent the inter-trial phase coherence."|baseline, five days post baseline|Per protocol; All eligible participants who completed every session of the study from the initial session through the one month follow-up that followed study protocol.|||inter-trial phase coherence||Standard Deviation|Mean
2583972|NCT02360228|Other Pre-specified|Change in Electroencephalogram (EEG) Auditory Tasks: Oddball Task From Baseline|"The investigators will compare auditory responses during auditory tasks EEG recordings on the first and last day of stimulation. The investigators will also collect EEG recordings data at the one week and one month follow up visits. The investigators will use each of the four EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers and look for increase in auditory responses.~Auditory oddball paradigm is an experimental design that has standard (low-pitch) and deviant (high-pitch) stimuli. Differences in ERP from these two stimuli can measure functions of sensory processing. Patients with schizophrenia often exhibit abnormal responses to the stimuli thus its discrepancy compared to healthy human participants can be a hallmark of symptoms in schizophrenia."|baseline, five days post baseline|Per protocol; All eligible participants who completed every session of the study from the initial session through the one month follow-up that followed study protocol.|||micro volts||Standard Deviation|Mean
2583973|NCT02360228|Secondary|Change in Brief Assessment of Cognition in Schizophrenia (BACS) Score|"The Brief Assessment of Cognition in Schizophrenia (BACS) is a battery of cognitive assessments assessing verbal memory and learning, working memory, motor function, verbal fluency, speed of processing, and executive function. Higher scores indicate better cognitive performance. The investigators will compare the BACS total scores immediately before first stimulation session and immediately after last stimulation session as secondary outcome measures.~Verbal Memory: Score out of 75~Digit Sequencing: Score out of 28~Token Motor: Score out of 100~Fluency: No score limit~Symbol Coding: Score out of 110~Tower of London: Score out of 22~Reported score is the mean of these 6 subtests. Healthy controls (Keefe et al., 2006) scored 45.6 as a comparison."|baseline, five days post baseline, five weeks post baseline|Per protocol; All eligible participants who completed every session of the study from the initial session through the one month follow-up that followed study protocol.|||scores on a scale||Standard Deviation|Mean
2583974|NCT02360228|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) Scores|The investigators will compare the PANSS total scores immediately before first stimulation session and immediately after last stimulation session as secondary outcome measures. Scores range from 30 to 210, with higher scores indicating more severe symptomology.|baseline, five days post baseline, five weeks post baseline|Per protocol; All eligible participants who completed every session of the study from the initial session through the one month follow-up that followed study protocol.|||scores on a scale||Standard Deviation|Mean
2583975|NCT02360228|Secondary|Change in Alpha Oscillations Measured With Electroencephalogram (EEG) Resting State From Baseline|The investigators will compare alpha oscillation power from resting state EEG recordings on the first and last day of stimulation. The investigators will also collect EEG recordings data at the one week and one month follow up visits. The investigators will use each of the four EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers.|Baseline, five days post baseline|Per protocol; All eligible participants who completed every session of the study from the initial session through the one month follow-up that followed the study protocol.|||decibel (dB)||Standard Deviation|Mean
2583976|NCT02360228|Primary|Proportional Change From Baseline in Auditory Hallucination Rating Scale (AHRS) Score|The Auditory Hallucination Rating Scale (AHRS) measures the severity of auditory hallucinations in the past week. The scale assesses frequency, duration, location, loudness, belief of origin of voices, negative content, distress, disruption to life, and control over voices. All items are measured on a scale of 0 to 4, with a total possible score of 44. Higher scores indicate higher severity of auditory hallucinations. The investigators will compare the AHRS scores from immediately before the first stimulation and immediately after the last stimulation session as the investigator's primary outcomes measure.|Baseline, five days post baseline, 2 weeks post baseline, 5 weeks post baseline|Per protocol; All eligible participants who completed every session of the study from the initial session through the one month follow-up that followed study protocol.|||proportion to baseline||Standard Deviation|Mean
2583977|NCT02360215|Other Pre-specified|MDASI-BT Mood Variables|The relationship between EQ-5D-5L and MDASI-BT mood variables and neurocognitive function will be assessed.|Up to 12 months|||||||
2584004|NCT02360124|Secondary|Proportion of Inactive Root Caries Lesions|the proportion of active tooth root caries lesions at baseline that has changed to inactive root caries lesions at the evaluation examination will be calculated. The calculation is to divide the number of caries lesions that have changed status from active to inactive (assessed in clinical examination) by the number of active caries lesions found at baseline|30 months|The participants were the active root caries lesions found at baseline in each group.|||percentage of inactive root caries|||Number
2583978|NCT02360215|Other Pre-specified|Effect of White Matter Injury and Hippocampal Volume on Neurocognitive Function|Evaluated through MRI scans using physician-contoured and auto-contoured scores. Concordance rates will be assessed using Kappa statistics. The auto-contoured scores will be used for the remaining analyses due to the number of physicians reviewing the scans. White matter injury is measured by FLAIR volume change and is a continuous variable. Hippocampal volume is measured as a continuous variable also and both will be covariates considered in the Cox proportional hazards model to assess the impact on time to neurocognitive failure and the longitudinal modeling of neurocognitive function.|Up to 12 months|||||||
2583979|NCT02360215|Other Pre-specified|Effect of Radiation Therapy Oncology Group (RTOG) RPA and the Diagnosis-specific Graded Prognostic Assessment (DSGPA) on Neurocognitive Function|Neurocognitive function, as measured by the HVLT-R, COWA, and TMT, will be correlated with both the RTOG RPA and the DS-GPA classification systems. Baseline neurocognitive function for each test will be compared between both RPA classes using either a t-test or Wilcoxon-Mann-Whitney test, depending on the normality of the data.|Up to 12 months|||||||
2583980|NCT02360215|Other Pre-specified|Anxiety/Depression Measured Using the EQ-5D-5L|"An exploratory analysis, beginning with correlation coefficients, will be used to assess the association of symptom burden and anxiety/depression with neurocognitive function at each time point. The symptom burden items of interest are the distressed (upset), sad, and mood items. From the EQ-5D-5L, the depression/anxiety item will be of interest."|Up to 12 months|||||||
2583981|NCT02360215|Secondary|Number of Patients With a Grade 3+ Adverse Event (AE) Regardless of Relationship to Treatment|. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.|From randomization to last follow-up. Analysis was planned to occur after 233 events were reported. Maximum follow-up was 15.6 months.|Randomized participants who started protocol treatment|||Participants|||Count of Participants
2583982|NCT02360215|Secondary|Overall Survival|Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Analysis was planned to occur after 233 primary endpoint events (neurocognitive failure) were reported. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Six-month rates are provided.|From randomization to last follow-up. Maximum follow-up was 15.6 months.|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2583983|NCT02360215|Secondary|Intracranial Progression-Free Survival|Intracranial progression-free survival time is defined as time from registration/randomization to the date of progression in the brain or death from any cause. Intracranial progression-free survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Analysis was planned to occur after 233 primary endpoint events (neurocognitive failure) were reported. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Six-month rates are provided.|From randomization to last follow-up. Analysis was planned to occur after 233 events were reported. Maximum follow-up was 15.6 months.|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2583984|NCT02360215|Secondary|Change in EQ-5D-5L VAS Score at 12 Months|The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The VAS score is reported here.|Baseline and 12 months|Participants with baseline and 6-month scores|||score on a scale||Standard Deviation|Mean
2583985|NCT02360215|Secondary|Change in EQ-5D-5L VAS Score at 6 Months|The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The VAS score is reported here.|Baseline and 6 months|Participants with baseline and 6-month scores|||score on a scale||Standard Deviation|Mean
2583986|NCT02360215|Secondary|Change in EQ-5D-5L VAS Score at 4 Months|The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The VAS score is reported here.|Baseline and 4 months|Participants with baseline and 4-month scores|||score on a scale||Standard Deviation|Mean
2583987|NCT02360215|Secondary|Change in EQ-5D-5L VAS Score at 2 Months|The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The VAS score is reported here.|Baseline and 2 months|Participants with baseline and 2-month scores|||score on a scale||Standard Deviation|Mean
2584005|NCT02360124|Primary|Number of New Tooth Root Caries Lesions|the number of new tooth root caries lesions, i.e. tooth roots that have changed from sound at baseline to decayed at the evaluation examination will be counted in the clinical examination|30 months||||new carious root surfaces||Standard Error|Mean
2596361|NCT02209766|Secondary|AUC(0-tau) in Plasma Baseline-adjusted Total EPA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2583988|NCT02360215|Secondary|Change in EQ-5D-5L Index Score at 12 Months|The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The index score is reported here.|Baseline and 12 months|Participants with baseline and 12-month scores|||score on a scale||Standard Deviation|Mean
2583989|NCT02360215|Secondary|Change in EQ-5D-5L Index Score at 6 Months|The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The index score is reported here.|Baseline and 6 months|Participants with baseline and 4-month scores|||score on a scale||Standard Deviation|Mean
2583990|NCT02360215|Secondary|Change in EQ-5D-5L Index Score at 4 Months|The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The index score is reported here.|Baseline and 4 months|Participants with baseline and 4-month scores|||score on a scale||Standard Deviation|Mean
2583991|NCT02360215|Secondary|Change in EQ-5D-5L Index Score at 2 Months|The EQ-5D-5L is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 5 problem levels (1-none to 5-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The index score is reported here.|Baseline and 2 months|Participants with baseline and 2-month scores|||score on a scale||Standard Deviation|Mean
2583992|NCT02360215|Secondary|Change in M. D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Neurologic Factor Score|The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score (Neurologic Factor) is the average of the subscale items, given that a specified minimum numbers of items were completed.|Baseline, 2, 4, 6, and 12 months|Participants with baseline data|||score on a scale||Standard Deviation|Mean
2583993|NCT02360215|Secondary|Change in M. D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Factor Score|The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score (Cognitive Factor) is the average of the subscale items, given that a specified minimum numbers of items were completed.|Baseline, 2, 4, 6, and 12 months|Participants with baseline data|||score on a scale||Standard Deviation|Mean
2583994|NCT02360215|Secondary|Change in M. D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Interference Score|The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score (Interference) is the average of the subscale items, given that a specified minimum numbers of items were completed.|Baseline, 2, 4, 6, and 12 months|Participants with baseline data|||score on a scale||Standard Deviation|Mean
2583995|NCT02360215|Secondary|Change in M. D. Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score|The MD Anderson Symptom Inventory for brain tumor (MDASI-BT) is a 28-item multi-symptom patient-reported outcome measure assessing the severity of symptoms experienced by cancer patients and the interference with daily living caused by these symptoms, with 9 items specific to brain tumors. Each item ranges from 0 (best condition) to 10 (worst condition). A subscale score (Symptom Severity) is the average of the subscale items, given that a specified minimum numbers of items were completed.|Baseline, 2, 4, 6, and 12 months|Participants with baseline data|||score on a scale||Standard Deviation|Mean
2583996|NCT02360215|Secondary|Change From Baseline in the Clinical Trial Battery Composite (CTB COMP) Score [Neurocognitive Decline]|Clinical Trial Battery Composite score is the arithmetic mean of the HVLT-R (Free Recall, Delayed Recall, Delayed Recognition), TMTA, TMTB, and COWA scores, all of which are standardized, adjusting for age, education, and gender as necessary, such that mean is 0 and standard deviation is 1. A participant must have at least 5 of the 6 scores. A higher composite score indicates better neurocognitive function.Change is calculated as baseline score subtracted from post-baseline score.|Baseline, 2, 4, 6, and 12 months|Participants with standardized score at baseline|||units on a scale||Standard Deviation|Mean
2583997|NCT02360215|Secondary|Change From Baseline in the Controlled Oral Word Association (COWA) Test (Neurocognitive Decline)|The COWA is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter. Patients are given 1 minute to name as many words as possible beginning with the designated letter. The procedure is then repeated for the remaining two letters. Two alternate forms of the COWA are employed to minimize practice effects. The score is the sum of the correct responses with a range of 0 to infinity. A higher score indicates better functioning. Scores are standardized, adjusting for age, education, and gender as necessary, such that mean is 0 and standard deviation is 1. Change is calculated as baseline score subtracted from post-baseline score.|Baseline, 2, 4, 6, and 12 months|Participants with standardized score at baseline|||units on a scale||Standard Deviation|Mean
2583998|NCT02360215|Secondary|Change From Baseline in the Trail Making Test (TMT) Part B (Neurocognitive Decline)|The TMT is a neuropsychological test of visual attention and task switching that can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. Subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. There are two parts to the test: in the first (Part A), the targets are all numbers (1, 2, 3, etc.) and the test taker needs to connect them in sequential order; in the second part (Part B), the subject alternates between numbers and letters (1, A, 2, B, etc.). The score is the amount of time, in seconds, that it takes the patient to complete each maze. The range for Part A is 0 to 180 (3 minutes) and for Part B is 0 to 300 (5 minutes). A lower score indicates better functioning. Scores are standardized by expressing the deviation from the mean score of the group in units of standard deviation. Change is calculated as baseline score subtracted from post-baseline score.|Baseline, 2, 4, 6, and 12 months|Participants with baseline data|||units on a scale||Standard Deviation|Mean
2583999|NCT02360215|Secondary|Change From Baseline in the Trail Making Test (TMT) Part A (Neurocognitive Decline)|The TMT is a neuropsychological test of visual attention and task switching that can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. Subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. There are two parts to the test: in the first (Part A), the targets are all numbers (1, 2, 3, etc.) and the test taker needs to connect them in sequential order; in the second part (Part B), the subject alternates between numbers and letters (1, A, 2, B, etc.). The score is the amount of time, in seconds, that it takes the patient to complete each maze. The range for Part A is 0 to 180 (3 minutes) and for Part B is 0 to 300 (5 minutes). Lower scores indicate better functioning. Scores are standardized, adjusting for age, education, gender as needed, so that mean is 0 and standard deviation is 1. Change is calculated as baseline score subtracted from post-baseline score.|Baseline, 2, 4, 6, and 12 months|Participants with standardized score at baseline|||units on a scale||Standard Deviation|Mean
2584000|NCT02360215|Secondary|Change From Baseline in the Hopkins Verbal Learning Test -Revised (HVLT-R) Delayed Recognition (Neurocognitive Decline)|The HVLT-R assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials (Total Recall), recalling the 12 targets after a 20-minute delay (Delayed Recall), and then identifying the 12 targets from a list of semantically related or unrelated items (delayed recognition). Raw scores are derived for total recall (sum of the number of targets correctly recalled), delayed recall (sum of the number of targets correctly recalled), and a delayed recognition discrimination index (sum of targets incorrectly identified subtracted from the sum of the number of targets correctly identified). The range of scores for total recall is 0 to 36, for delayed recall is 0 to 12, and -12 to 12 for recognition. A higher score indicates better functioning. Scores are standardized by expressing the deviation from the mean score of the group in units of standard deviation. Change is calculated as baseline score subtracted from post-baseline score.|Baseline, 2, 4, 6, and 12 months|Participants with baseline data|||units on a scale||Standard Deviation|Mean
2584001|NCT02360215|Secondary|Change From Baseline in the Hopkins Verbal Learning Test -Revised (HVLT-R) Delayed Recall Score (Neurocognitive Decline)|The HVLT-R assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials (Total Recall), recalling the 12 targets after a 20-minute delay (Delayed Recall), and then identifying the 12 targets from a list of semantically related or unrelated items (delayed recognition). Raw scores are derived for total recall (sum of the number of targets correctly recalled), delayed recall (sum of the number of targets correctly recalled), and a delayed recognition discrimination index (sum of targets incorrectly identified subtracted from the sum of the number of targets correctly identified). The range of scores for total recall is 0 to 36, for delayed recall is 0 to 12, and -12 to 12 for recognition. A higher score indicates better functioning. Scores are standardized, adjusting for age, education, and gender as necessary, such that mean 0 and standard deviation is 1. Change is calculated as baseline score subtracted from post-baseline score.|Baseline, 2, 4, 6, and 12 months|Participants with standardized score at baseline|||units on a scale||Standard Deviation|Mean
2584002|NCT02360215|Secondary|Change From Baseline in the Hopkins Verbal Learning Test -Revised (HVLT-R) Total Recall Score (Neurocognitive Decline)|The HVLT-R assesses verbal learning and memory. The test involves memorizing a list of 12 nouns for 3 consecutive trials (Total Recall), recalling the 12 targets after a 20-minute delay (Delayed Recall), and then identifying the 12 targets from a list of semantically related or unrelated items (delayed recognition). Raw scores are derived for total recall (sum of the number of targets correctly recalled), delayed recall (sum of the number of targets correctly recalled), and a delayed recognition discrimination index (sum of targets incorrectly identified subtracted from the sum of the number of targets correctly identified). The range of scores for total recall is 0 to 36, for delayed recall is 0 to 12, and -12 to 12 for recognition. A higher score indicates better functioning. Scores are standardized, adjusting for age, education, and gender as necessary, such that mean 0 and standard deviation is 1. Change is calculated as baseline score subtracted from post-baseline score.|Baseline, 2, 4, 6, and 12 months|Participants with standardized score at baseline|||units on a scale||Standard Deviation|Mean
2584003|NCT02360215|Primary|Time to Neurocognitive Failure|Neurocognitive failure is defined as the first failure, defined as a neurocognitive decline using the reliable change index (RCI) on at least one of the following assessments or parts of : Hopkins Verbal Learning Test - Revised (HVLT-R), Trail Making Test (TMT), or Controlled Oral Word Association (COWA). The HVLT-R has 3 parts that were analyzed separately for decline: Total Recall, Delayed Recall, and Delayed Recognition. The TMT has 2 parts that were analyzed separately: Part A and Part B. Neurocognitive failure rate is estimated using the cumulative incidence method. Analysis was planned to occur after 233 events were reported. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Six-month rates are provided.Analysis was planned to occur after 233 events were reported.|From randomization to last follow-up. Maximum follow-up was 15.6 months.|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2584006|NCT02360111|Secondary|The Occurrence of Life-threatening Opportunistic Infections|will be evaluated according to the criteria established by BMT CTN , and will be correlated with the level of immune recovery.|2 years|Protocol terminated prematurely due to low accrual||||||
2596362|NCT02209766|Secondary|AUC(0-tau) in Plasma Baseline-adjusted Total DHA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2584007|NCT02360111|Secondary|# Renal Insufficiency Defined as a Calculated eGFR <60 ml/Min/1.73m2. Those With a eGFR < 30 ml/Min/1.73m2 Will be Considered Ineligible.|Renal insufficiency is defined as a calculated eGFR <60 ml/min/1.73m2. Those with a eGFR < 30 ml/min/1.73m2 will be considered ineligible.|2 years|Protocol terminated prematurely due to low accrual||||||
2584008|NCT02360111|Secondary|Overall Survival|Overall survival is defined as time from transplant to death or last follow-up.|2 years|Protocol terminated prematurely due to low accrual||||||
2584009|NCT02360111|Secondary|Disease-free Survival|DFS is defined as the minimum interval of time to relapse/recurrence, to death or to the last follow-up, from the time of transplant|2 years|Protocol terminated prematurely due to low accrual||||||
2584010|NCT02360111|Primary|# GVHD (Grade II-IV) Chronic GVHD Will be Diagnosed and Graded According to the (NIH Criteria)|Chronic GVHD will be diagnosed and graded according to the (NIH criteria) treated with standard or experimental immunosuppressive therapy.|2 years|Protocol terminated prematurely due to low accrual||||||
2584011|NCT02360059|Primary|Mean Change in Neuropathy|"Change in neuropathy as assessed with the chemotherapy-induced peripheral neuropathy (CIPN) survey QLQ-CIPN20 between T1 and T5 where difference in mean area under the curve (AUC) between groups reported. The AUC for response from T1 to T5 is computed by fitting a series of trapezoids to the QLQ-CIPN20 data assessed at T1, T2, T3, T4, and T5, respectively, and summing up their areas [AUC calculated - base of a trapezoid corresponds to the number of days between assessments, and the heights correspond to two adjoining symptom responses, number of trapezoids depends on number of symptom assessments and sum of area for all trapezoids represents AUC of particular participant]. QLQ-CIPN20 contains 20 items assessing sensory (9 items), motor (8 items), and autonomic symptoms (3 items) using a 4-point Likert scale (1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much) with the higher score denoting more symptom burden."|Up to 14 weeks, assessed every 3 weeks ±1 week (T2, T3, T4, T5) during paclitaxel therapy|Study stopped early with only one participant, analysis not possible.||||||
2584012|NCT02359955|Primary|EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months)|"the masseters EMG are recorded after patient wears complete denture for three months,EMGs of masseters of 20 chewing strokes were recorded in term of value of amp and duration, duration here is reporteds the average value from 20 chewing strokes in units of millisecond."|three month||||millisecond||Standard Deviation|Mean
2584013|NCT02359955|Primary|EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months)|"the masseters EMG are recorded after patient wears complete denture for three months,EMGs of masseters of 20 chewing strokes were recorded in term of value of amp and duration,amplitude is reported here as the average value from 20 chewing strokes in units of microvolts."|three months||||microvolts||Standard Deviation|Mean
2584014|NCT02359955|Secondary|Masticatory Efficiency Index|the masticatory efficiency is tested after patient wears complete denture for three months,each patient was given 4 gram dry peanuts, chewed for 20 seconds, then spat in the receptacle and rinsed mouth residue. The peanut particles were diluted to 1000 ml with distilled water, stirred for 1 minutes and standing for 2 minutes to suspension. Absorbance values(av) were measured at the wavelength of 590nm in a spectrophotometer. The higher the masticatory efficiency, the smaller the peanut particles, then the higher the av value, vice versa. Value of av was used to represent masticatory efficiency. For each patient, the test was conducted three times, and the average value of av was taken as the final result. A lower masticatory efficiency index indicates larger peanut particle size observed.|three months||||index score||Standard Deviation|Mean
2584015|NCT02359916|Secondary|Total Daily Vending Revenue in US$/Day|Total vending machine revenue under each condition|Number of days per condition were as follows - Baseline: 119 days, Discount only: 59 days, Delay only: 68 days, Delay + Discount: 49 days, Tax only: 73 days, Delay + Tax: 60 days|"The unit of analysis is vending revenue per day ($/day). Data from Baseline 1 and Baseline 2 were combined into a single arm/group (Baseline) in this analysis."|||$/day|Days|Standard Deviation|Mean
2584016|NCT02359916|Primary|Proportion of Healthy Snacks Purchased|For each experimental condition, we will calculate the proportion of healthy vs unhealthy snacks sold over 4 weeks.|28 weeks per vending location|"In this table, each vend is treated as an analyzed participant. No data were collected from individual human subjects. Analyses included all available data on healthy and regular snack vends. Data from Baseline 1 and Baseline 2 were combined into a single arm/group (Baseline) in statistical analyses."|||proportion of vends from healthy snacks|Vends||Number
2584017|NCT02359903|Other Pre-specified|Area Under the Plasma Concentration-time Curve at Steady State Phase||28 weeks||2016-12-31|12/2016||||
2584018|NCT02359903|Other Pre-specified|Maximum Concentration at Steady State||28 weeks||2016-12-31|12/2016||||
2584019|NCT02359903|Secondary|Frequency of Early Withdrawal Due to AE/SAE||30 weeks|||||||
2584020|NCT02359903|Secondary|Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected||screening / 14 weeks / 30 weeks|||||||
2584021|NCT02359903|Secondary|Total Frequency of Grade 3-4 Laboratory Abnormalities Within the Whole Time of the Study||30 weeks|||||||
2584022|NCT02359903|Secondary|Total Frequency of AE/SAE Within the Whole Time of the Study||30 weeks|||||||
2584023|NCT02359903|Secondary|Frequency of AE/SAE After the Single Infusion of BCD-055/Remicade||2 weeks|||||||
2584024|NCT02359903|Secondary|Mean Change of Chest Expansion Compared With Baseline||14 weeks / 30 weeks|||||||
2584025|NCT02359903|Secondary|Mean Change of SF36 Score Compared With Baseline||14 weeks / 30 weeks|||||||
2584026|NCT02359903|Secondary|Mean Change of MASES Score Compared With Baseline||14 weeks / 30 weeks|||||||
2584027|NCT02359903|Secondary|Mean Change of BASFI Score Compared With Baseline||14 weeks / 30 weeks|||||||
2584028|NCT02359903|Secondary|Mean Change of BASMI Score Compared With Baseline||14 weeks / 30 weeks|||||||
2584029|NCT02359903|Secondary|Mean Change of BASDAI Score Compared With Baseline||14 weeks / 30 weeks|||||||
2584030|NCT02359903|Secondary|Percentage of Patients in Each Group Achieving ASAS40||14 weeks / 30 weeks|||||||
2584031|NCT02359903|Secondary|Percentage of Patients in Each Group Achieving ASAS20||14 weeks / 30 weeks|||||||
2584032|NCT02359903|Secondary|Average Concentration of Infliximab at Steady State Phase||28 weeks|||||||
2584033|NCT02359903|Secondary|Half Life of Infliximab After the 1st and 5th Infusion of BCD-055/Remicade||2 weeks / 28 weeks|||||||
2584038|NCT02359903|Secondary|Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade|Patients who received at least 1 injection. From BCD-055 group 1 patient was excluded because of violation of timing of blood collection. From Remicade group 2 patients were excluded due to AE/SAE.|2 weeks||||ng/ml||Inter-Quartile Range|Median
2584039|NCT02359903|Primary|Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade||2 weeks|Patients who received at least 1 injection. From BCD-055 group 1 patient was excluded because of violation of timing of blood collection. From Remicade group 2 patients were excluded due to AE/SAE.|||(ng/ml)*hour||Inter-Quartile Range|Median
2584040|NCT02359890|Secondary|Effectiveness Endpoint: Freedom From Documented Atrial Fibrillation (AF)/Atrial Tachycardia (AT)/Atrial Flutter (AFL)|The freedom from documented AF/AT/AFL based on electrocardiographic data|12 months|Effectiveness per Protocol Population, which is defined as enrolled subjects who underwent RF ablation procedure with study catheter and completed the 12 month visit.|||Percentage of Participants||95% Confidence Interval|Number
2584041|NCT02359890|Secondary|Percentage of Participants With Acute Success|Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).|End of procedure|Safety Population (SP), which is defined as the enrolled subjects who had the study catheter inserted.|||Percentage of participants||95% Confidence Interval|Number
2584042|NCT02359890|Secondary|Percentage of Participants With Non-Primary Serious Adverse Events (SAEs)|This secondary safety endpoint includes non-primary serious adverse events (SAEs) within 7 days post-procedure and serious adverse events from 8 days to 30 days post-procedure|Up to 30 days post Procedure|Safety Population (SP), which is defined as the enrolled subjects who had the study catheter inserted.|||Percentage of Participants|||Number
2584043|NCT02359890|Primary|Percentage of Participants With Early Onset Primary Adverse Events|Early onset is defined as within 7 days of the atrial fibrillation (AF) ablation procedure. Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade / Perforation, Pneumothorax, Major Vascular Access Complications / Bleeding, Pulmonary edema (Respiratory Insufficiency), and Heart block.|Seven days post ablation procedure|The modified intent-to-treat (mITT) population was used, which consisted of enrolled subjects who met the eligibility criteria and had the study catheter inserted.|||Percentage of participants||95% Confidence Interval|Number
2584044|NCT02359877|Primary|Adverse Event (AE) and Serious Adverse Event (SAE) Incidence BCD-054 - 180 mcg - SC/IM|Stage 2 BCD-054 - 180 mcg - SC/IM|4 weeks||||participants|||Number
2584045|NCT02359877|Primary|Adverse Event (AE) and Serious Adverse Event (SAE) Incidence|Stage 1|4 weeks||||participants|||Number
2584046|NCT02359877|Primary|AUC(0-∞), AUC(0-last) of Neopterin|Stage 2 primary outcome measure for pharmacodynamics analysis. Area under concentration-time curve (AUC) of neopterin from the moment of drug administration until last quantifiable concentration|0 to 672 hours||||(nmol/L)*hour||Inter-Quartile Range|Median
2584047|NCT02359877|Primary|AUC (0-168); AUC (0-336); AUC (0-672);AUC (0-∞ ) of Neopterin|Stage 1 primary outcome measure for pharmacodynamics analysis. Area under concentration-time curve (AUC) of neopterin from the moment of drug administration until 168, 336, 648 hours respectively|0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively||||nmol/L*hour||Inter-Quartile Range|Median
2584048|NCT02359877|Primary|AUC(0-last); AUC (0-∞ ) BCD-054 of Interferon (IFN) Beta-1a - 180 mcg - SC, BCD-054 - 180 mcg - IM|Stage 2 primary outcome measure for pharmacokinetics analysis. Area under concentration-time curve (AUC) of interferon (IFN) beta-1a from the moment of drug administration until last quantifiable concentration|0 to 672 hours||||(pg/ml)*hour||Inter-Quartile Range|Median
2584049|NCT02359877|Primary|AUC (0-168); AUC (0-336); AUC (0-672); AUC (0-∞ ) of Interferon (IFN) Beta-1a|Stage 1 primary outcome measure for pharmacokinetics analysis. Area under concentration-time curve (AUC) of interferon (IFN) beta-1a from the moment of drug administration up to 168, 336, 648 hours respectively|0 to 168 hours; 0 to 336 hours; 0 to 672 hours respectively||||(pg/ml)*hour||Inter-Quartile Range|Median
2584050|NCT02359851|Other Pre-specified|Changes in Molecular Characteristics of Uveal Melanoma When Treated With Pembrolizumab|Each relevant clinical characteristic will be recorded by the use of tables and/or graphs. The number and percentage of patients treated, and the primary reason for discontinuation will be displayed. Demographic variables (such as age) and baseline characteristics will be summarized by descriptive statistics. Compliance with pembrolizumab administration will be measured by patients: 1) receiving unscheduled study agent infusions/injections; 2) missing an infusion/injection. Numbers and percentages of patients and infusion/injection visits with any deviation in these measures will be reported.|Baseline up to 2 years|||||||
2584051|NCT02359851|Other Pre-specified|Change in PD-L1 Expression Status on Archival or Fresh Tissue From All Patients and Correlate With ORR|Differences in PFS and OS between subgroups will be assessed by the stratified logrank test. Differences in ORR between subgroups will be assessed by the Pearson chi-square test. No adjustments will be made for multiple comparisons.|Baseline up to 2 years|||||||
2584052|NCT02359851|Other Pre-specified|Changes in GNAQ/GNA11 Mutation Status on Each Patient Per Institutional Protocol|Differences in PFS and OS between subgroups will be assessed by the stratified logrank test. Differences in ORR between subgroups will be assessed by the Pearson chi-square test. No adjustments will be made for multiple comparisons.|Baseline up to 2 years|||||||
2584053|NCT02359851|Secondary|Number of Patients With Each Worst‐Grade Toxicity. Incidence of Adverse Events, Using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death. This endpoint will be reported descriptively without formal statistical analysis.|Up to 30 days after the last dose of trial treatment||||Participants|||Count of Participants
2584054|NCT02359851|Secondary|Response Duration|If sample size permits, response duration will be summarized descriptively using Kaplan-Meier medians and quartiles. Only the subset of patients who show a complete response or partial response will be included in this analysis.|Up to 3 years|Only 1 participant had a RECIST-defined response, which is ongoing and lasting 23.5 months.|||months|||Number
2584055|NCT02359851|Secondary|Overall Survival (OS) Defined as Number of Patients Surviving up to 3 Years.|The Kaplan-Meier method will be used to estimate the overall survival. Median survival and its 95% confidence interval will be estimated and reported.|Interval between the first dose of pembrolizumab and death for any reason, assessed up to 3 years|Patients received pembrolizumab treatment.|||Participants|||Count of Participants
2584056|NCT02359851|Secondary|Progression-Free Survival (PFS) Defined as Time From Treatment to Progression Defined by RECIST1.1 Criteria or Death.|PFS will be summarized using the method of Kaplan and Meier. Median PFS time with 95% confidence intervals will be reported. Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), progression will be defined as ≥ 20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest diameter recorded or the appearance of one or more new lesions, and/or appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.|Time from the first dose of pembrolizumab to progression, assessed up to 3 years.|Patients received treatment.|||months||95% Confidence Interval|Median
2584057|NCT02359851|Primary|Objective Response Rate (ORR), Defined as the Percentage of Patients Achieving a Confirmed Complete or Partial Response, as Defined by Immune-related Response Criteria (irRC)|Of note, response rates by RECIST 1.1 criteria will also be assessed although irRC will be used for the primary endpoint. The percentage of complete or partial response is calculated and 95% confidence interval is estimated using Wilson method.|Up to 3 years|Patients received pembrolizumab treatment and evaluated for response.|||% of patients achieving response||95% Confidence Interval|Mean
2584058|NCT02359435|Primary|Number of Participants in Which H. Pylori Was Eradicated|Evaluate eradication outcome by endoscopy urease test and histology or urea breath test|at the 6th week after the end of anti- H. pylori therapy|Intention to treat|||participants|||Number
2584059|NCT02359305|Secondary|PACU Time|Time spent in the post-anesthesia care unit post-operatively.|45-60 minutes post-operatively||||minutes||Standard Deviation|Mean
2584060|NCT02359305|Primary|Average FLACC Pain Score in the PACU|The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain.|0-60 minutes post-operatively||||units on a scale 0-10||Standard Deviation|Mean
2584061|NCT02359305|Primary|Acetaminophen Dosage|One time in the OR prior to the start of surgery|Baseline||||mg/kg||Standard Deviation|Mean
2584062|NCT02359110|Secondary|Total Morphine Consumption||12 hours post-operatively||||mg||Standard Deviation|Mean
2584063|NCT02359110|Secondary|VAS (Visual Analog Scale)|"The VAS is scored using a horizontal line 100mm in length. The scale is anchored by no pain (score of 0) and worst pain (score of 100)."|2 -6 hours|Our analysis uses all available data. Some participants were not in house for the full 6 hours of collection, others did not complete VAS at the respective time point. Therefore the number at each time point differs from the overall number of participants.|||units on a scale||95% Confidence Interval|Least Squares Mean
2584064|NCT02359110|Primary|NRS (Numerical Rating Scale)|The NRS is a numerical scale ranging from 0-10 implemented with adults. Having no pain is rated as a 0 and the worst pain the patient could tolerate is rated as a 10.|2-8 hours|Our analysis uses all available data. Some participants were not in house for the full 8 hours of collection, others did not complete NRS at the respective time point. Therefore the number at each time point differs from the overall number of participants.|||units on a scale||95% Confidence Interval|Least Squares Mean
2584065|NCT02359058|Secondary|Number of Participants With Treatment Emergent Anti-Ramucirumab Antibodies (TE-ADA)|Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group.|First dose to study completion plus 30-day safety follow-up (Up To 22 Months)|All enrolled participants who received at least one dose of the study drug and had evaluable immunogenicity data.|||Participants|||Count of Participants
2584066|NCT02359058|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)|Objective response rate (ORR) was defined as the percentage of randomized participants achieving a best confirmed overall response of CR or PR using Response Evaluation Criteria in Solid Tumors (RECIST v1). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions, taking as reference the baseline sum LD and no progression in non-target lesions.|First Dose to Date of Objective Progressive Disease or Death Due to Any Cause (Up To 22 Months)|All enrolled participants who received at least one dose of study drug and with measurable disease.|||Percentage of participants|||Number
2584067|NCT02359058|Secondary|Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of Ramucirumab|Minimum Serum Concentration (Cmin) of Ramucirumab.|Day 8, Day 22, Day 29, Day 43, Day 50, Day 64, Day 71, Day 85, Day 92 and Day 106: Pre-Dose|All enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2584068|NCT02359058|Secondary|Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Ramucirumab|Maximum Serum Concentration (Cmax) of Ramucirumab.|Day 1, Day 8, Day 43, Day 50, Day 85 and Day 92: End of Infusion|All enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data.|||microgram per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2584069|NCT02359058|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|First Dose to Study Completion Plus 30-Day Safety Follow-Up (Up To 22 Months)|All enrolled participants who received at least one dose of study drug.|||Participants|||Count of Participants
2584070|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Urinalysis|To evaluate the safety by assessing the number of subjects with clinically significant urinalysis results after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.|||Participants|||Number
2584071|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Clinical Chemistry Laboratory Results|To evaluate the safety by assessing the number of subjects with clinically significant clinical chemistry laboratory results after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.|||Participants|||Number
2584072|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Hematology Parameters|To evaluate the safety by assessing the number of subjects with clinically significant hematology parameters after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.|||Participants|||Number
2584073|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant 12-lead Electrocardiograms (ECGs)|To evaluate the safety by assessing the number of subjects with clinically significant 12-lead ECGs after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.|||Participants|||Number
2584074|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Pulse|To evaluate the safety by assessing the number of subjects with clinically significant pulse after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.|||Participants|||Number
2584075|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects With Clinically Significant Blood Pressure|To evaluate the safety by assessing the number of subjects with clinically significant blood pressure after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.|||Participants|||Number
2584076|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Number of Subjects Who Had at Least One Adverse Event|To assess the safety by analyzing the number of subjects with at least one adverse event after administration of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing.|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.|||Partcipants|||Number
2584077|NCT02359045|Secondary|Safety of Omega-3-carboxylic Acids by Assessing Summary of Adverse Events|To assess the safety summary of single doses of the omega-3-carboxylic acids test formulations and Epanova in healthy subjects|From screening (within 28 days of first dosing) up to 14 days after last dosing|Subjects were analyzed based on safety analysis set. Safety Analysis Set is defined as All subjects who received at least one dose of IMP were included in the safety analysis for the study.|||Participants|||Number
2584078|NCT02359045|Secondary|λz Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of λz for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(1/h)||Geometric Coefficient of Variation|Geometric Mean
2584079|NCT02359045|Secondary|λz Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of λz for DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(1/h)||Geometric Coefficient of Variation|Geometric Mean
2584080|NCT02359045|Secondary|Terminal Elimination Rate Constant (λz ) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of λz for EPA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(1/hour)||Geometric Coefficient of Variation|Geometric Mean
2584081|NCT02359045|Secondary|Tmax Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of tmax for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(hour)||Full Range|Median
2584082|NCT02359045|Secondary|Tmax Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of tmax for DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(hour)||Full Range|Median
2584083|NCT02359045|Secondary|Time to Reach Maximum Observed Concentration (Tmax) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of tmax for EPA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(hour)||Full Range|Median
2584084|NCT02359045|Secondary|t½λz Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of t½λz for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(hour)||Geometric Coefficient of Variation|Geometric Mean
2584085|NCT02359045|Secondary|t½λz Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of t½λz for DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(hour)||Geometric Coefficient of Variation|Geometric Mean
2584086|NCT02359045|Secondary|Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of t½λz for EPA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(hour)||Geometric Coefficient of Variation|Geometric Mean
2584087|NCT02359045|Secondary|C0 Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of C0 for Total (combined) EPA + DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(nmol/mL)||Geometric Coefficient of Variation|Geometric Mean
2584114|NCT02359006|Secondary|Profile of Mood States (POMS) Depression Subscale|"The POMS is a 65-item scale that divides items amongst eight mood states (tension, depression, anger, fatigue, confusion, vigor) on a 5-point rating scale (0=not at all to 5=extremely). We analyzed the 15-item Depression subscale, which has a minimum score of 0 and a maximum score of 75. Higher score indicate more agreement with the statement/more feelings of depression."|One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)||||score on a scale||Standard Deviation|Mean
2584088|NCT02359045|Secondary|C0 Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of C0 for DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2584089|NCT02359045|Secondary|Baseline Concentration (C0) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of C0 for EPA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2584090|NCT02359045|Secondary|AUC (Last) Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (last) for Total (combined) EPA + DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentration.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(nmol*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2584091|NCT02359045|Secondary|AUC (Last) Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (last) for DHA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentration.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2584092|NCT02359045|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Analyte Concentration {AUC (Last)} Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (last) for EPA on baseline subtracted plasma concentrations and baseline unadjusted plasma concentration.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2584093|NCT02359045|Primary|Cmax Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of Cmax for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(nmol/mL)||Geometric Coefficient of Variation|Geometric Mean
2584094|NCT02359045|Primary|Cmax Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of Cmax for DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2584150|NCT02358668|Secondary|Changes in Waist Circumference in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||cm||Standard Deviation|Mean
2584095|NCT02359045|Primary|Maximum Observed Plasma Concentration (Cmax) Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of Cmax for EPA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2584096|NCT02359045|Primary|AUC (0-72) Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (0-72) for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(nmol*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2584097|NCT02359045|Primary|AUC (0-72) Assessed for DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (0-72) for DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2584098|NCT02359045|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to 72 Hours After Dosing {AUC(0-72)} Assessed for EPA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC (0-72) for EPA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2584099|NCT02359045|Primary|AUC Assessed for Total (Combined) EPA + DHA After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC for Total (combined) EPA + DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(nmol*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2584100|NCT02359045|Primary|AUC Assessed for Docosahexaenoic Acids (DHA) After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000 mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC for DHA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||(μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2584101|NCT02359045|Primary|Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC) Assessed for Eicosapentaenoic Acid (EPA) After Administration of Test Formulation 1, 2 and 3 and Reference Formulation.|To assess the rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 (Omega-3-carboxylic acids 2000 mg uncoated/coated capsules) and reference formulation (Epanova 1000mg) under fasted (Part 1) and fed condition (Part 2), by assessment of AUC for EPA on baseline subtracted plasma concentrations.|Pre-dose: -12, -1 and 0 hours and Post dose: 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours|Subjects were analyzed based on PK analysis set. It consisted of all subjects in the safety analysis set for whom the primary PK parameters could be calculated for at least 2 treatment periods including the reference formulation, and who had no major protocol deviations thought to impact on the analysis of the PK data.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2584130|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 3 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||95% Confidence Interval|Mean
2584102|NCT02359006|Secondary|Sustained Attention to Response Test (SART): Go Trials: Errors of Omission|"The SART is a Go No-Go task. It assesses the ability to withhold responses to an infrequently occurring target (No-Go trials).The SART is a Go No-Go task. It assesses the ability to withhold responses to an infrequently occurring target (No-Go trials). A total of 225 single digits (25 x 9 digits) are presented on a computer monitor for 250 ms each, immediately followed by a mask for 900 ms. Subjects must press a spacebar in response to every digit except the 3. Higher numbers indicate more errors of omission."|Baseline (Day 0), Pre- and 1-hour post-medication treatment on Test Days 8, 15 and 22, and at Follow-up (~Day 28||||ommission errors||Standard Deviation|Mean
2584103|NCT02359006|Secondary|Sustained Attention to Response Test (SART): No-go Trials: Errors of Commission|"The SART is a Go No-Go task. It assesses the ability to withhold responses to an infrequently occurring target (No-Go trials). A total of 225 single digits (25 x 9 digits) are presented on a computer monitor for 250 ms each, immediately followed by a mask for 900 ms. Subjects must press a spacebar in response to every digit except the 3. Higher numbers indicate more errors of commission."|Baseline (Day 0), Pre- and 1-hour post-medication treatment on Test Days 8, 15 and 22, and at Follow-up (~Day 28||||commission errors||Standard Deviation|Mean
2584104|NCT02359006|Secondary|Digit Symbol Substitution Test|The DSST is a test of psychomotor performance, which measures motor persistence, sustained attention, response speed and visuomotor coordination. The task is to fill in blank spaces with the symbols that are paired with the number above the blank space as fast as possible for 90 sec. The minimum score is 0 and the maximum score is 120. Higher numbers indicate better cognitive performance.|Baseline (Day 0), Pre- and 1-hour post-medication treatment on Test Days 8, 15 and 22, and at Follow-up (~Day 28||||score on a scale||Standard Deviation|Mean
2584105|NCT02359006|Secondary|Ecological Momentary Assessments (EMA): SOWS|Self-report opioid withdrawal scale. Withdrawal symptoms are measured on a 7-point Likert scale (1=strongly disagree, 7=strongly agree). Participants complete these ratings 4 times per day on days 8-14 of medication treatment. All scores were averaged to compute one score. Higher scores indicate more withdrawal symptoms.|4x/day over one week||||score on a scale||Standard Deviation|Mean
2584106|NCT02359006|Secondary|Ecological Momentary Assessments (EMA) - Craving|"Participants will be asked Are you craving heroin at this moment on seven-point Likert scales (1=strongly disagree to 7=strongly agree) 4 times per day outside of the laboratory (in their natural environment) using a personal digital assistant on days 8-14 of medication treatment. All scores were averaged to compute one score. Higher scores indicate more craving for heroin."|4x/day for one week||||score on a scale||Standard Deviation|Mean
2584107|NCT02359006|Secondary|Ecological Momentary Assessments (EMA) - Pain|"Participants will be asked Do you feel any pain at this moment on seven-point Likert scales (1=strongly disagree to 7=strongly agree) 4 times per day outside of the laboratory (in their natural environment) using a personal digital assistant on days 8-14 of medication treatment. All scores were averaged to compute one score. Higher scores indicate more feelings of pain."|4x/day for one week||||score on a scale||Standard Deviation|Mean
2584108|NCT02359006|Secondary|Tumor Necrosis Factor Alpha (TNF-α)|Serum cytokine analysis assayed using electrochemiluminescence multi-array technology (Meso Scale Discovery, Gaithersburg, MD). TNF-α is measured in pictograms per milliliter (pg/ml).Cytokines were assessed at screening (approximately 1 week prior to medication), and on the last day of medication treatment. Higher numbers indicate higher blood levels of this cytokine.|Pre/post : At Screening before medication, and on Day 22 of medication||||pictograms per milliliter||Standard Deviation|Mean
2584109|NCT02359006|Secondary|Interleukin-6 (IL-6)|Serum cytokine analysis assayed using electrochemiluminescence multi-array technology (Meso Scale Discovery, Gaithersburg, MD). IL-6 is measured in pictograms per milliliter (pg/ml).Cytokines were assessed at screening (approximately 1 week prior to medication), and on the last day of medication treatment. Higher numbers indicate higher blood levels of this cytokine.|Pre/post : At Screening before medication, and on Day 22 of medication||||pictograms per milliliter||Standard Deviation|Mean
2584110|NCT02359006|Secondary|Interleukin-1 Beta (IL-1β)|Serum cytokine analysis assayed using electrochemiluminescence multi-array technology (Meso Scale Discovery, Gaithersburg, MD). IL-1β is measured in pictograms per milliliter (pg/ml). Cytokines were assessed at screening (approximately 1 week prior to medication), and on the last day of medication treatment. Higher numbers indicate higher blood levels of this cytokine.|Pre/post : At Screening before medication, and on Day 22 of medication||||pictograms per milliliter||Standard Deviation|Mean
2584111|NCT02359006|Secondary|Short-Form McGill Pain Questionnaire (SF-MPQ): Affective Subscale|This measure is a subscale of the SF-MPQ, comprised of 4 of the 15 total items. The measure is completed immediately after the CPT, where participants describe their experience of CPT pain by choosing among a series of possible answers [none (score=0), mild (score=1), moderate (score=2), or severe (score=3)]. The items to describe the pain are 'Tiring-Exhausting', 'Sickening', 'Fearful', 'Punishing-Cruel'. The scores for these 4 items are summed as a measure of Affective pain, with a minimum score of 0 and a maximum score of 12.|One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)||||score on a scale||Standard Deviation|Mean
2584112|NCT02359006|Secondary|Short-Form McGill Pain Questionnaire (SF-MPQ): Sensory Subscale|This measure is a subscale of the SF-MPQ, comprised of 11 of the 15 total items. The measure is completed immediately after the CPT, where participants describe their experience of CPT pain by choosing among a series of possible answers [none (score=0), mild (score=1), moderate (score=2), or severe (score=3)]. The items to describe the pain are 'Throbbing','Shooting', 'Stabbing', 'Sharp', 'Cramping', 'Gnawing', 'Hot/burning', 'Aching', 'Heavy', 'Tender', and 'Splitting'. The scores for these 11 items are summed as a measure of Sensory pain, with a minimum score of 0 and a maximum score of 33.|One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)||||score on a scale||Standard Deviation|Mean
2584113|NCT02359006|Secondary|Profile of Mood States (POMS) - Total Mood Disturbance|"The POMS is a 65-item scale that divides items amongst eight mood states (tension, depression, anger, fatigue, confusion, vigor) on a 5-point rating scale (0=not at all to 5=extremely). Total Mood Disturbance is calculated by adding the tension, depression, anger, fatigue, and confusion subscale scores and subtracting the vigor subscale score. This has a minimum of 0 and a maximum score of 210. Higher score indicate more mood disturbance."|One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)||||score on a scale||Standard Deviation|Mean
2584115|NCT02359006|Secondary|Opioid Withdrawal Symptom Checklist (OWSC): Back Pain Item|"For safety reasons, withdrawal signs and symptoms were assessed using a 22-item withdrawal instrument that has been reliably used to assess opiate withdrawal. As an additional assessment of daily pain, the presence of back pain item was analyzed. This item has a minimum score of 0 and maximum score of 4, with higher scores indicates more agreement with statement/more back pain."|One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)||||score on a scale||Standard Deviation|Mean
2584116|NCT02359006|Secondary|Brief Pain Inventory - Short Form: Interference|"Brief Pain Inventory - Short Form: BPI-SF is a self-report questionnaire that assesses 7 questions each rated on a scale of 0-10, which are added and divided by 7. This average score of 7 questions gives a pain interference with living score, with a minimum score of 0 and a maximum score of 10.~Higher scores indicate that pain interferes more with aspects of daily life."|One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)||||score on a scale||Standard Deviation|Mean
2584117|NCT02359006|Secondary|Brief Pain Inventory - Short Form: Pain Severity|Brief Pain Inventory - Short Form: BPI-SF is a self-report questionnaire that assesses the impact of pain on daily function, location of pain, pain medications, and amount of pain relief in the past 24 hours or the past week. Each question is scored 0-10, and the scores are summed and then averaged to create a pain severity score. Minimum score is 0; maximum score is 10. Higher scores indicate more severely perceived pain.|One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)||||score on a scale||Standard Deviation|Mean
2584118|NCT02359006|Primary|Pain Tolerance|The Cold Pressor Test (CPT) measures pain threshold and pain tolerance (in seconds). For this test, two water coolers filled with either warm (100.04ºF/37.8ºC) or cold water (32.9-34.7ºF/0.5-1.5ºC) are used. To begin the CPT, participants first immerse their hand into the warm-water bath for 2 min. Participants are then instructed to immerse their hand into the cold water bath and report when the pain becomes unbearable (pain tolerance). Lower scores indicate lower pain tolerance. Minimum score is 0 seconds, and a maximum cut-off score of 300 seconds is used to prevent tissue damage.|One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)||||seconds||Standard Deviation|Mean
2584119|NCT02359006|Primary|Pain Threshold|The Cold Pressor Test (CPT) measures pain threshold (in seconds). For this test, two water coolers filled with either warm (100.04ºF/37.8ºC) or cold water (32.9-34.7ºF/0.5-1.5ºC) are used. To begin the CPT, participants first immerse their hand into the warm-water bath for 2 min. Participants are then instructed to immerse their hand into the cold water bath and report the first time they experience pain (pain threshold). Lower scores indicate lower pain threshold. Minimum score is 0 seconds, and a maximum cut-off score of 300 seconds is used to prevent tissue damage.|One measurement at each of 5 weekly sessions: Baseline, Day 8, Day 15, Day 22 and at Follow-up (~Day 28)||||seconds||Standard Deviation|Mean
2584120|NCT02358876|Primary|Percentage of Kinesia One Assessments Performed|Percentage of Kinesia One assessments performed as directed|Two weeks||||percentage of home assessments completed||Standard Deviation|Mean
2584121|NCT02358863|Primary|The Number of Patients With Tumor Size Reduction (Objective Response Rate)|Objective response rate is the sum of partial responses plus complete responses and will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|1 year||||Participants|||Count of Participants
2584122|NCT02358668|Other Pre-specified|Changes in Complete Blood Count in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo||From baseline to Week 4, Week 8, Week 12, and Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||g/dL||Standard Deviation|Mean
2584123|NCT02358668|Other Pre-specified|Changes in Measures of Liver Function in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo||From baseline to Week 4, Week 8, Week 12, and Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320.|||IU/L||Standard Deviation|Mean
2584124|NCT02358668|Other Pre-specified|Changes in Serum Creatinine in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||umol/L||Standard Deviation|Mean
2584125|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||% of coefficient of variation||95% Confidence Interval|Mean
2584126|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 3 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||% of coefficient of variation||95% Confidence Interval|Mean
2584127|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 2 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||% of coefficient of variation||95% Confidence Interval|Mean
2584128|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 1 Hour Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||% of coefficient of variation||95% Confidence Interval|Mean
2584129|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose Over 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||95% Confidence Interval|Mean
2584518|NCT02355665|Secondary|Pulse at Week 16|Pulse (beats per minute)|Week 16|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||beats per minute||Standard Deviation|Mean
2584131|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 2 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||95% Confidence Interval|Mean
2584132|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 1 Hour Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||95% Confidence Interval|Mean
2584133|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Post-prandial Maximum Glucose During 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||95% Confidence Interval|Mean
2584134|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Post-prandial Maximum Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||95% Confidence Interval|Mean
2584135|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Blood Glucose During 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16||||mmol/L||95% Confidence Interval|Mean
2584136|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 3 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||95% Confidence Interval|Mean
2584137|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 2 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||95% Confidence Interval|Mean
2584138|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 1 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||95% Confidence Interval|Mean
2584139|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 3 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L*hour||95% Confidence Interval|Mean
2584140|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 2 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L*hour||95% Confidence Interval|Mean
2584141|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 1 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L*hour||95% Confidence Interval|Mean
2584142|NCT02358668|Secondary|Changes in Measures of Exercise in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo|Changes in the number of days per week that the subject spent walking for at least 10 minutes from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||Days||Standard Deviation|Mean
2584143|NCT02358668|Secondary|Changes in Measures of Nutritional Intake in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo|Changes in daily calories intake from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||kcal||Standard Deviation|Mean
2584144|NCT02358668|Secondary|Changes in Measures of Food Satiety in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo|"Changes to question of how full do you feel in the Appetite Questionnaire adopted from Hill and Blundell from baseline and Week 16. Scale score ranges from minimum of 0 to maximum of 10. 10 being the most full and 0 being the least full."|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||units on a scale||Standard Deviation|Mean
2584145|NCT02358668|Secondary|Changes in Quality of Life Measures in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo|Changes in WHOQOL-BREF physical health domain score from baseline to Week 16. This is a sub-scale of the WHOQOL-BREF. Possible scores range from minimal of 4 to maximum of 20. Higher score indicate better physical health domain.|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||units on a scale||Standard Deviation|Mean
2584146|NCT02358668|Secondary|Changes in Urate in Subjects Treated With High Dose and Lose Dose BTI320 Compared to Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||Standard Deviation|Mean
2584147|NCT02358668|Secondary|Changes in High-sensitivity C-reactive Protein in Subjects Treated With High Dose and Low Dose BTI320 Compared Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mg/L||Standard Deviation|Mean
2584148|NCT02358668|Secondary|Changes in Lipids in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo|Changes in total cholesterol from baseline to Week 16.|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||Standard Deviation|Mean
2584149|NCT02358668|Secondary|Changes in Body Weight in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||kg||Standard Deviation|Mean
2584151|NCT02358668|Secondary|Changes in Blood Pressures in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo|Changes in systolic blood pressures from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmHg||Standard Deviation|Mean
2584152|NCT02358668|Secondary|Proportion of Subjects With Impaired Fasting Glucose or Impaired Glucose Tolerance in Low Dose BTI320, High Dose BTI320 and Placebo Group|Proportion of subjects with impaired fasting glucose, impaired glucose tolerance, both impaired fasting glucose and impaired glucose tolerance, HbA1c 5.7-6.4%, or type 2 diabetes at 30 days post-treatment|From baseline to 30 days post-treatment|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||percentage of subjects|||Number
2584153|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Glucagon-like Peptide 1 During Standard Meal Tolerance Test From 0 Minute to 120 Minutes|Changes in area under curve of glucagon-like peptide-1 from 0 minute to 120 minutes from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||pmol/L*minute||Standard Deviation|Mean
2584154|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of C-peptide During Standard Meal Tolerance Test From 0 Minute to 120 Minutes|Changes in area under curve of C-peptide from 0 minute to 120 minutes from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||ug/L*minute||Standard Deviation|Mean
2584155|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of Insulin During Standard Meal Tolerance Test From 0 Minute to 120 Minutes|Changes in area under curve of insulin from 0 minute to 120 minutes from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mIU/L*minute||Standard Deviation|Mean
2584156|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of Glucose During Standard Meal Tolerance Test From 0 Minute to 120 Minutes|Changes in area under curve of glucose from 0 minute to 120 minutes from baseline to Week 16|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L*minute||Standard Deviation|Mean
2584157|NCT02358668|Secondary|Changes in Fructosamine in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||umol/L||Standard Deviation|Mean
2584158|NCT02358668|Secondary|Changes in HbA1c in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||percent glycated hemoglobin||Standard Deviation|Mean
2584159|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation on Continuous Glucose Monitoring System||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||% of coefficient of variation||Standard Deviation|Mean
2584160|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Glucose on Continuous Glucose Monitoring System||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||Standard Deviation|Mean
2584161|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve for Glucose Levels >180mg/dL on Continuous Glucose Monitoring System|Area under curve for glucose levels >180 mg/dL over 72 hours|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L*hour||Standard Deviation|Mean
2584162|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Blood Glucose on Continuous Glucose Monitoring System||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||Standard Deviation|Mean
2584163|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Amplitude of Glucose Excursion on Continuous Glucose Monitoring System||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||Standard Deviation|Mean
2584164|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose BTI320 and High Dose BTI320 Compared With Placebo in Mean Post-meal Maximum Glucose on Continuous Glucose Monitoring System||From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L||Standard Deviation|Mean
2584165|NCT02358668|Secondary|Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System|"Changes in 3-hour post-prandial glucose incremental area under curve on continuous glucose monitoring system from baseline to Week 16.~Note that this is not a pharmacokinetic study and this is not pharmacokinetic data as we are not measuring drug levels. Here we are examining glucose levels after meals as one of the anticipated glycemic outcomes of using glucose-lowering therapy (BTI320 in this case). With data-analysis based on continuous glucose monitoring, it is conventional to present post-prandial (i.e. post-meal) glucose incremental area under curve at up to 3 hours. It is not meaningful to look at post-meal glucose changes at more than 3 hours after meal for the obvious reason that subject might have taken another meal by then."|From baseline to Week 16|Intention to treat, as defined by all subjects who have received at least one dose of BTI320|||mmol/L*hour||Standard Deviation|Mean
2584166|NCT02358668|Primary|Change in Serum Fructosamine in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo||From baseline to Week 4|Intention to treat, as defined by all subjects who have received at least one dose of BTI320.|||umol/L||Standard Deviation|Mean
2584258|NCT02357940|Primary|Percentage With Scaling on the Legs at Baseline Before Investigational Product Application|Percentage of adults and babies with scaling on the legs at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584167|NCT02358603|Primary|Chronotropic Incompetence Index of Patients With Heart Failure Disease|"Compare chronotropic incompetence index in patients with heart failure using an interventional diagnostic algorithm compared to standard of care diagnostics.~Chronotropic Index = [achieved maximal HR−resting HR]/[age‐predicted maximal HR−resting HR]. Normal CI is ~ 1 with low CI considered < 0.8~Measurement described as: Chronotropic index=HRR/metabolic reserve."|Implant through 6 months|Compare the case group for chronotropic incompetence using the interventional algorithm versus those in the control group.|||Index||Standard Deviation|Mean
2584168|NCT02358473|Secondary|Overall Survival||One year||||months||95% Confidence Interval|Median
2584169|NCT02358473|Secondary|Progression Free Survival by RECIST 1.1||One year||||months||95% Confidence Interval|Median
2584170|NCT02358473|Secondary|Overall Response Rate||One year||||Participants|||Count of Participants
2584171|NCT02358473|Primary|Number of Subjects Experiencing Dose-limiting Toxicity||First dose of study medications through 4 weeks after the last dose of study medication||||Participants|||Count of Participants
2584172|NCT02358473|Primary|Number of Subjects Reporting Serious Adverse Events||Screening through 90 days after the last dose of study medication||||Participants|||Count of Participants
2584173|NCT02358473|Primary|Number of Subjects Reporting Adverse Events||Screening through 90 days after the last dose of study medication||||Participants|||Count of Participants
2584174|NCT02358343|Secondary|Serum Phosphorus Level|Treatment Adherence with Diet and/or Medications as defined by Serum phosphorus level measured as a part of routine clinical care during the third month of participation in the study.|Week 12|In addition to participants withdrawn / died, 8 participants were missing serum phosphorus level at week 12: 3 in CBT arm and 5 in Drug arm.|||mg/dl||95% Confidence Interval|Mean
2584175|NCT02358343|Secondary|Percent Inter-dialytic Weight Gain|Treatment Adherence with Fluid Intake as defined by inter-dialytic weight gain (as % of post-dialysis weight) during Week 12 of the study|Week 12|In addition to participants withdrawn / died, 11 participants were missing average weight gain at week 12: 3 in CBT arm and 8 in Drug arm.|||percentage of body weight||95% Confidence Interval|Mean
2584176|NCT02358343|Secondary|Percentage of Dialysis Treatment Sessions Skipped and/or Shortened|Treatment Adherence with Dialysis as defined by the percentage of all dialysis sessions skipped and/or requested by the patient to be shortened by ≥ 10 minutes over the 12-week intervention period. Dialysis sessions missed due to hospitalization will not be included as a skipped treatment.|Over 12 Weeks||||percentage of sessions skipped/shortened||95% Confidence Interval|Mean
2584177|NCT02358343|Secondary|Exercise|Single item activity measure, range 1-6, higher indicates less activity|Week 12|Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 1 participant in the drug arm.|||score on a scale||95% Confidence Interval|Mean
2584178|NCT02358343|Secondary|PSQI|Pittsburgh Sleep Quality Index, range 0-21, higher scores indicate worse sleep quality|Week 12|Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 11 participants in the CBT arm and 13 participants in the drug arm.|||score on a scale||95% Confidence Interval|Mean
2584179|NCT02358343|Secondary|Perceived Social Support|Multi-Dimensional Scale of Perceived Social Support, range 1-7, higher scores indicate better social support|Week 12|Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 2 participants in the drug arm.|||score on a scale||95% Confidence Interval|Mean
2584180|NCT02358343|Secondary|Satisfaction With Life Scale|range 1-35, higher scores indicate better satisfaction|Week 12|Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 1 participant in the drug arm.|||score on a scale||95% Confidence Interval|Mean
2584181|NCT02358343|Secondary|Global Quality of Life Scale|range 0-10, higher scores indicate better quality of life|Week 12|Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks.|||score on a scale||95% Confidence Interval|Mean
2584182|NCT02358343|Secondary|SF-36 Energy/Vitality|Energy/vitality subscale of the 36-Item Short Form Health Survey, range 0-100, higher scores indicate better energy/vitality|Week 12|Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 2 participants in the CBT arm and 4 participants in the drug arm.|||score on a scale||95% Confidence Interval|Mean
2584183|NCT02358343|Secondary|Sheehan Disability Scale|range 0-30, higher scores indicate worse disability|Week 12|Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 3 participants in the CBT arm and 1 participant in the drug arm.|||score on a scale||95% Confidence Interval|Mean
2584184|NCT02358343|Secondary|GAD-7|Generalized Anxiety Disorder 7-item Scale, range 0-21, higher scores indicate worse anxiety|Week 12|Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 3 participants in the CBT arm and 4 participants in the drug arm.|||score on a scale||95% Confidence Interval|Mean
2584185|NCT02358343|Secondary|BDI-II|Beck Depression Inventory-II, range 0-63, higher scores indicate worse depression|Week 12|Due to patient preference, 2 participants in the CBT arm and 5 in the Drug arm were not administered secondary outcome questionnaires at 12 weeks. In addition, due to non-response at 12 weeks, this outcome is missing for 5 participants in the CBT arm and 2 participants in the drug arm.|||score on a scale||95% Confidence Interval|Mean
2584259|NCT02357940|Primary|Percentage With Scaling on the Arms at Baseline Before Investigational Product Application|Percentage of adults and babies with scaling on the arms at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584186|NCT02358343|Secondary|Number of Participants Who Accepted Depression Treatment|"The secondary measure of efficacy of the Engagement Interview will be the % of patients undergoing hemodialysis with co-morbid depression who are willing to accept treatment.~This will be measured by the patient's intent and will be defined as one of the following:~Signing the informed consent to be randomly assigned to individual CBT or drug therapy~Receiving a referral by the research team and/or primary care physician and/or treating nephrologist to a therapist for psychotherapy in the community.~Receiving a prescription for anti-depressant drug therapy from primary care physician and/or treating nephrologist within two weeks of establishing a diagnosis of major depression/dysthymia."|within two weeks of engagement interview or control visit|Screening Intervention Period. Two participants who died both consented to treatment within the clinical trial and therefore were counted as non-missing for accepting treatment outcome by definition even though they did not complete the study.|||Participants|||Count of Participants
2584187|NCT02358343|Primary|QIDS-C Score|The Quick Inventory of Depressive Symptomatology Clinician-rated (QIDS-C) scale ranges from 0-27, higher scores indicate worse depression. The primary measure of efficacy of Intervention will be the mean difference in QIDS-C score at Week 12 between treatment groups.|Week 12 of treatment|QIDS-C in Observational Cohort arm provided only for descriptive purposes, not a primary outcome.|||score on a scale||95% Confidence Interval|Mean
2584188|NCT02358343|Primary|Number of Participants Who Initiated Depression Treatment|"The primary measure of efficacy of the Engagement Interview will be the number of patients undergoing hemodialysis with co-morbid depression who initiate treatment for the condition.~This will be defined as one of the following:~Completing at least one psychotherapy session either as a part of the clinical trial or in the community within four weeks of establishing a diagnosis of major depression and/or dysthymia.~Receiving a supply of anti-depressant drug either as a part of the clinical trial or the treating physician within four weeks of establishing a diagnosis of major depression and/or dysthymia."|within four weeks of engagement interview or control visit||||Participants|||Count of Participants
2584189|NCT02358135|Secondary|Access to Care: Wait Time|Access to care is an overall term to capture transportation factors including time taken to be seen by a provider. me. Wait time is measured by calculating roundtrip transportation time plus in-office waiting time multiplied by the number of in-person visits during the study period.|12 months||||Hours||Standard Deviation|Mean
2584190|NCT02358135|Secondary|Other Psoriasis Disease Severity Measures|"Body surface area (BSA) involvement and patient global assessment (PtGA) will be compared between the patients randomized to the CCH model and the in-person care.~The BSA assessment is a well-established, validated measure used by psoriasis patients to report percent body surface affected by psoriasis in numerous prior studies. BSA ranges from 0% (no involvement) to 100% (complete body surface affected). The PtGA is a validated instrument that measures the overall psoriasis severity from the patients' perspective.40 PtGA is an ordinal six-point scale ranging from 0 (clear) to 5 (severe)."|12 months||||Score on a scale||Standard Deviation|Mean
2584191|NCT02358135|Secondary|Depression Severity|"Participants will be assessed for depression severity using the Patient Health Questionnaire (PHQ), a validated, self-administered diagnostic instrument for common mental disorders. The PHQ-9 score can range from 0 to 27 with 0 = No depression and 27 = Severe depression.~The PHQ is a validated, self-administered version of the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) depression criteria as 0 (not at all) to 3 (nearly every day). A PHQ-9 score of 10 or greater has 89% sensitivity and 88% specificity for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. PHQ-9 is a validated tool for diagnosis of depression and monitoring response to interventions."|12 months||||Score on a scale||Standard Deviation|Mean
2584192|NCT02358135|Secondary|Access to Care: Distance Traveled|Access to care is an overall term to capture the transportation to care factors including total distance traveled to see a provider (round-trip driving distance from patient's home to provider's office multiplied by the number of in-person visits during the study period).|12 months.||||Kilometers||Standard Deviation|Mean
2584193|NCT02358135|Secondary|Improvement in Quality of Life as Measured by Dermatology-Specific, Quality of Life Instruments|"Quality of life will be assessed using dermatology-specific, quality of life instruments, Skindex-16 and Dermatology Life Quality Index (DLQI). Scores for these assessments will be compared between patients randomized to the CCH model and in-person care.~Skindex-16 is a validated and reliable instrument that comprehensively captures the effects of skin disease on health-related quality of life. It discriminates among patients with different effects and is responsive to clinical changes over time. Skindex-16 scores range from 0 (no effect) to 100 (effect experienced all the time), and the responses are aggregated in symptoms, emotions, and functioning subscales.~The Dermatology Life Quality Index (DLQI) is another validated dermatology-specific quality-of-life instrument that has been used in many psoriasis trials. DLQI scores range from 0 to 30, with higher scores indicating more severe impact on quality of life."|12 months||||Score on a Scale||Standard Deviation|Mean
2584194|NCT02358135|Primary|Improvement in Self-Administered Psoriasis Area and Severity Index (SA-PASI)|Participants are asked to complete self-administered Psoriasis Area and Severity Index (SA-PASI). SA-PASI combines the assessment of lesion severity (erythema, induration, and scale) and the affected areas into a single score between 0 (no disease) to 72 (maximal disease). The primary outcome of the study was the mean percent improvement in SA-PASI averaged over three, six, nine, and 12 months. The percent improvement in SA-PASI was defined as the difference in SA-PASI scores between the baseline and each of the follow-up visits divided by the SA-PASI score from the baseline visit.|12 months||||Score on a Scale||Standard Deviation|Mean
2584195|NCT02358044|Secondary|Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After Ending Study Treatment (SVR4)|HCV-RNA levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR4 was defined as HCV RNA <LLOQ at 4 weeks after the end of all study therapy.|4 weeks after end of all therapy (Study Week 16)|FAS; all randomized participants who receive at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
2584519|NCT02355665|Secondary|Pulse at Week 12|Pulse (beats per minute)|Week 12|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||beats per minute||Standard Deviation|Mean
2584196|NCT02358044|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Ending Study Treatment (SVR24)|HCV-RNA levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR24 was defined as HCV RNA <LLOQ at 24 weeks after the end of all study therapy.|24 weeks after end of all therapy (Study Week 36)|FAS; all randomized participants who receive at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.|||percentage of participants|||Number
2584197|NCT02358044|Secondary|Percentage of Participants Experiencing at Least One Tier 1 Safety Event (Key Safety Parameter) During the Treatment Period and First 14 Follow-up Days|Tier 1 safety events were pre-specified by the protocol to evaluate safety and test the safety superiority hypothesis. Tier 1 safety events were chosen to assess broad tolerability, hematological side effects and liver-related laboratory abnormalities. For this study, Tier 1 safety events included: any serious drug-related AE, any drug-related AE leading to permanent discontinuation (DC) of all study drugs, neutrophil count <0.75 x 10^9/L, hemoglobin <10 g/dL, severe depression, hepatic events of clinical interest (defined by abnormal increases in alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP]), or events meeting stopping rule criteria for DC from trial (due to abnormal increases of ALT, AST, or ALP with/without pre-specified related AEs). The percentage of participants who experienced each individual event that was defined as a Tier 1 safety event during the study treatment period was reported for each treatment arm.|Treatment + First 14 days of follow-up (Up to Week 14)|ASaT population; all randomized participants who received at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.|||percentage of participants|||Number
2584198|NCT02358044|Primary|Percentage of Participants Discontinuing Study Treatment Due to an AE|"An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE.~The percentage of participants who discontinued study treatment due to an AE was reported for each treatment arm. Participants that discontinued study drug treatment due to an AE may have still continued on trial."|Up to Week 12|ASaT population; all randomized participants who received at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.|||percentage of participants|||Number
2584199|NCT02358044|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period Plus First 14 Follow-up Days|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants who experienced at least one AE was reported for each treatment arm.|Treatment + First 14 days of follow-up (Up to Week 14)|All Subjects as Treated (ASaT) population; all randomized participants who received at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.|||percentage of participants|||Number
2584200|NCT02358044|Primary|Primary: Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of All Treatment (SVR12)|Hepatitis C Virus ribonucleic acid (HCV-RNA) levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR12 was defined as HCV RNA below the lower limit of quantification (<LLOQ) at 12 weeks after the end of all study therapy. The primary efficacy hypothesis for this study was that the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir arm was non-inferior to the percentage in the SOF plus PR arm. A secondary statistical analysis was performed to determine whether the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir arm was superior to the percentage in the SOF plus PR arm.|12 weeks after end of all therapy (Study Week 24)|FAS; all randomized participants who receive at least one dose of study treatment. Two participants in the SOF + PR arm withdrew from study prior to treatment and were excluded from analysis.|||percentage of participants|||Number
2584201|NCT02358031|Secondary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that discontinued study drug due to an AE was reported for each treatment arm.|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|All randomized participants who received ≥1 dose of study drug.|||Participants|||Count of Participants
2584202|NCT02358031|Secondary|Number of Participants Experiencing an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm.|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|All randomized participants who received ≥1 dose of study drug.|||Participants|||Count of Participants
2605719|NCT02107014|Primary|Change in HGF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2584203|NCT02358031|Secondary|Pembro Mono vs Control: TTD in the EORTC QLQ- H&N35 Swallowing Score|EORTC QLQ-H&N35 is a 35-item questionnaire developed to assess QoL of head and neck cancer participants and consists of 7 multi-item scales that assess pain, swallowing, senses, speech, social eating, social contact and sexuality. Participant responses to the Swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. TTD in EORTC QLQ-H&N35 Swallowing Score defined as the time from baseline to the first onset of a ≥10 point decrease from baseline, with confirmation. Per protocol, TTD in EORTC QLQ-H&N35 Swallowing Score was compared between all participants of pembro mono arm and control arm as a pre-specified secondary analysis. Also per protocol, TTD in EORTC QLQ-H&N35 Swallowing Score was compared separately between all participants of pembro combo arm and control arm and is presented earlier in the record.|Baseline up to approximately 12 months|All participants in the pembro mono arm and control arm who completed the EORTC QLQ-H&N35 and had received ≥1 dose of study drug. Per protocol, the pembro combo arm was compared to the control arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2584204|NCT02358031|Secondary|Pembro Mono vs Control: TTD in the EORTC QLQ- H&N35 Pain Score|EORTC QLQ-H&N35 is a 35-item questionnaire developed to assess QoL of head and neck cancer participants and consists of 7 multi-item scales that assess pain, swallowing, senses, speech, social eating, social contact and sexuality. Participant responses to the Pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. TTD in EORTC QLQ-H&N35 Pain Score defined as the time from baseline to the first onset of a ≥10 point decrease from baseline, with confirmation. Per protocol, TTD in EORTC QLQ-H&N35 Pain Score was compared between all participants of pembro mono arm and control arm as a pre-specified secondary analysis. Also per protocol, TTD in EORTC QLQ-H&N35 Pain Score was compared separately between all participants of pembro combo arm and control arm and is presented earlier in the record.|Baseline up to approximately 12 months|All participants in the pembro mono arm and control arm who completed the EORTC QLQ-H&N35 and had received ≥1 dose of study drug. Per protocol, the pembro combo arm was compared to the control arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2584205|NCT02358031|Secondary|Pembro Mono vs Control: TTD in the EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score|"EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the GHS question How would you rate your overall health during the past week? (Item 29) and the QoL question How would you rate your overall quality of life during the past week? (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD in GHS/QoL defined as the time from baseline to the first onset of a ≥10 point decrease from baseline in GHS/QoL combined score, with confirmation. Per protocol, TTD in GHS/QoL combined score was compared between all participants of pembro mono arm and control arm as a pre-specified secondary analysis. Also per protocol, TTD in GHS/QoL combined score was compared separately between all participants of pembro combo arm and control arm and is presented earlier in the record."|Baseline up to approximately 12 months|All participants in the pembro mono arm and the control arm who completed the EORTC QLQ-C30 and had received ≥1 dose of study drug. Per protocol, the pembro combo arm was compared to the control arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2584206|NCT02358031|Secondary|Pembro Mono vs Control: Change From Baseline to Week 15 in the EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score|"The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the GHS question How would you rate your overall health during the past week? (Item 29) and the QoL question How would you rate your overall quality of life during the past week? (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 15 in the GHS/QoL combined score was compared between all participants of the pembro mono arm and the control arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 15 in the GHS/QoL combined score was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record."|Baseline, Week 15|All participants in the pembro mono arm and the control arm who received ≥1 dose of study drug and had EORTC-QLQ-C30 assessments available at baseline or post-baseline up to Week 15. Per protocol, the pembro combo arm was compared to the control arm separately and not included in this analysis.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2584207|NCT02358031|Secondary|Pembro Mono vs Control: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20|ORR was defined as the percentage of participants in the analysis population who have a CR (disappearance of all target lesions) or a PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥20 in the pembro mono arm and control arm. Per protocol, ORR was compared separately between CPS ≥20 participants of the pembro combo arm and control arm and is presented earlier in the record.|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥20 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2584260|NCT02357940|Primary|Percentage With Scaling on the Face at Baseline Before Investigational Product Application|Percentage of adults and babies with scaling on the face at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584261|NCT02357940|Primary|Percentage With Edema on the Torso at Day 14|Percentage of adults and babies with edema on the torso at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584208|NCT02358031|Secondary|Pembro Mono vs Control: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1|ORR was defined as the percentage of participants in the analysis population who have a CR (disappearance of all target lesions) or a PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥1 in the pembro mono arm and control arm. Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro combo arm and control arm and is presented earlier in the record.|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥1 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2584209|NCT02358031|Secondary|Pembro Mono vs Control: ORR Per RECIST 1.1 by BICR in All Participants|ORR was defined as the percentage of participants in the analysis population who have a CR (disappearance of all target lesions) or a PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro mono arm and control arm. Per protocol, ORR was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record.|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2584210|NCT02358031|Secondary|Pembro Mono vs Control: Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥20|"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 12 months is reported here out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥20 in the pembro mono arm and control arm. Per protocol, the percentage of participants with PFS at 12 months was compared separately between CPS ≥20 participants of the pembro combo arm and control arm and is presented earlier in the record."|Month 12|All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥20 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2584211|NCT02358031|Secondary|Pembro Mono vs Control: Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥1|"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 12 months is reported here out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥1 in the pembro mono arm and control arm. Per protocol, the percentage of participants with PFS at 12 months was compared separately between CPS ≥1 participants of the pembro combo arm and control arm and is presented earlier in the record."|Month 12|All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥1 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2584212|NCT02358031|Secondary|Pembro Mono vs Control: Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among All Participants|"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 12 months is reported here out of all participants in the pembro mono arm and control arm. Per protocol, the percentage of participants with PFS at 12 months was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record."|Month 12|All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2584262|NCT02357940|Primary|Percentage With Edema on the Legs at Day 14|Percentage of adults and babies with edema on the legs at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584263|NCT02357940|Primary|Percentage With Edema on the Arms at Day 14|Percentage of adults and babies with edema on the arms at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584264|NCT02357940|Primary|Percentage With Edema on the Face at Day 14|Percentage of adults and babies with edema on the face at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584520|NCT02355665|Secondary|Pulse at Week 8|Pulse (beats per minute)|Week 8|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||beats per minute||Standard Deviation|Mean
2584213|NCT02358031|Secondary|Pembro Mono vs Control: Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥20|"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 6 months is reported here out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥20 in the pembro mono arm and control arm. Per protocol, the percentage of participants with PFS at 6 months was compared separately between CPS ≥20 participants of the pembro combo arm and control arm and is presented earlier in the record."|Month 6|All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥20 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2584214|NCT02358031|Secondary|Pembro Mono vs Control: Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥1|"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 6 months is reported here out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥1 in the pembro mono arm and control arm. Per protocol, the percentage of participants with PFS at 6 months was compared separately between CPS ≥1 participants of the pembro combo arm and control arm and is presented earlier in the record."|Month 6|All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥1 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2584215|NCT02358031|Secondary|Pembro Mono vs Control: Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among All Participants|"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 6 months is reported here out of all participants in the pembro mono arm and control arm. Per protocol, the percentage of participants with PFS at 6 months was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record."|Month 6|All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2584216|NCT02358031|Secondary|Pembro Combo vs Control: TTD in the EORTC QLQ- H&N35 Swallowing Score (Kaplan-Meier Method)|EORTC QLQ-H&N35 is a 35-item questionnaire developed to assess QoL of head and neck cancer participants and consists of 7 multi-item scales that assess pain, swallowing, senses, speech, social eating, social contact and sexuality. Participant responses to the Swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. TTD in EORTC QLQ-H&N35 Swallowing Score defined as the time from baseline to the first onset of a ≥10 point decrease from baseline, with confirmation. Per protocol, TTD in EORTC QLQ-H&N35 Swallowing Score was compared between all participants of pembro combo arm and control arm as a pre-specified secondary analysis. Also per protocol, TTD in EORTC QLQ-H&N35 Swallowing Score was compared separately between all participants of pembro mono arm and control arm and is presented later in the record.|Baseline up to approximately 12 months|All participants in the pembro combo arm and control arm who completed the EORTC QLQ-H&N35 and had received ≥1 dose of study drug. 20 in the control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, the pembro mono arm was compared to the control arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2584217|NCT02358031|Secondary|Pembro Combo vs Control: TTD in the EORTC QLQ- Head and Neck Module 35 (H&N35) Pain Score (Kaplan-Meier Method)|EORTC QLQ-H&N35 is a 35-item questionnaire developed to assess QoL of head and neck cancer participants and consists of 7 multi-item scales that assess pain, swallowing, senses, speech, social eating, social contact and sexuality. Participant responses to the Pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. TTD in EORTC QLQ-H&N35 Pain Score defined as the time from baseline to the first onset of a ≥10 point decrease from baseline, with confirmation. Per protocol, TTD in EORTC QLQ-H&N35 Pain Score was compared between all participants of pembro combo arm and control arm as a pre-specified secondary analysis. Also per protocol, TTD in EORTC QLQ-H&N35 Pain Score was compared separately between all participants of pembro mono arm and control arm and is presented later in the record.|Baseline up to approximately 12 months|All participants in the pembro combo arm and control arm who completed the EORTC QLQ-H&N35 and had received ≥1 dose of study drug. 20 in the control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, the pembro mono arm was compared to the control arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2584265|NCT02357940|Primary|Percentage With Edema on the Torso at Day 7|Percentage of adults and babies with edema on the torso at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2596369|NCT02209766|Secondary|Cmax in Plasma Baseline-adjusted Total Docosahexaenoic Acid (DHA), Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2584218|NCT02358031|Secondary|Pembro Combo vs Control: Time to Deterioration (TTD) in the EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score (Kaplan-Meier Method)|"EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the GHS question How would you rate your overall health during the past week? (Item 29) and the QoL question How would you rate your overall quality of life during the past week? (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. TTD in GHS/QoL defined as the time from baseline to the first onset of a ≥10 point decrease from baseline in GHS/QoL combined score, with confirmation. Per protocol, TTD in GHS/QoL combined score was compared between all participants of pembro combo arm and control arm as a pre-specified secondary analysis. Also per protocol, TTD in GHS/QoL combined score was compared separately between all participants of pembro mono arm and control arm and is presented later in the record."|Baseline up to approximately 12 months|All participants in the pembro combo arm and the control arm who completed the EORTC QLQ-C30 and had received ≥1 dose of study drug. 20 in the control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, the pembro mono arm was compared to the control arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2584219|NCT02358031|Secondary|Pembro Combo vs Control: Change From Baseline to Week 15 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score|"The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question How would you rate your overall health during the past week? (Item 29) and the Quality of Life (QoL) question How would you rate your overall quality of life during the past week? (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 15 in the GHS/QoL combined score was compared between all participants of the pembro combo arm and the control arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 15 in the GHS/QoL combined score was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record."|Baseline, Week 15|Participants in pembro combo arm and control arm who received ≥1 dose of study drug and with EORTC-QLQ-C30 assessments available at baseline or post-baseline up to Week 15. 20 in control arm enrolled during enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm compared to control arm separately and not included here.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2584220|NCT02358031|Secondary|Pembro Combo vs Control: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20|ORR was defined as the percentage of participants in the analysis population who have a CR (disappearance of all target lesions) or a PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥20 in the pembro combo arm and control arm. Per protocol, ORR was compared separately between CPS ≥20 participants of the pembro mono arm and control arm and is presented later in the record.|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥20 were analyzed. 12 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2584221|NCT02358031|Secondary|Pembro Combo vs Control: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1|ORR was defined as the percentage of participants in the analysis population who have a CR (disappearance of all target lesions) or a PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥1 in the pembro combo arm and control arm. Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro mono arm and control arm and is presented later in the record.|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥1 were analyzed. 20 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2584222|NCT02358031|Secondary|Pembro Combo vs Control: Objective Response Rate (ORR) Per RECIST 1.1 by BICR in All Participants|ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro combo arm and control arm. Per protocol, ORR was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record.|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|All participants in the ITT population randomized to either the pembro combo arm or control arm during active enrollment were analyzed. 22 participants in the control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2584266|NCT02357940|Primary|Percentage With Edema on the Legs at Day 7|Percentage of adults and babies with edema on the legs at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2596370|NCT02209766|Secondary|Tmax in Plasma Baseline-adjusted Total EPA, Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||h||Full Range|Median
2584223|NCT02358031|Secondary|Pembro Combo vs Control: Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥20|"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 12 months is reported here out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥20 in the pembro combo arm and control arm. Per protocol, the percentage of participants with PFS at 12 months was compared separately between CPS ≥20 participants of the pembro mono arm and control arm and is presented later in the record."|Month 12|Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥20 were analyzed. 12 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2584224|NCT02358031|Secondary|Pembro Combo vs Control: Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥1|"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 12 months is reported here out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥1 in the pembro combo arm and control arm. Per protocol, the percentage of participants with PFS at 12 months was compared separately between CPS ≥1 participants of the pembro mono arm and control arm and is presented later in the record."|Month 12|Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥1 were analyzed. 20 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2584225|NCT02358031|Secondary|Pembro Combo vs Control: Percentage of Participants With PFS at 12 Months Per RECIST 1.1 by BICR Among All Participants|"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 12 months is reported here out of all participants in the pembro combo arm and control arm. Per protocol, the percentage of participants with PFS at 12 months was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record."|Month 12|All participants in the ITT population randomized to either the pembro combo arm or control arm during active enrollment were analyzed. 22 participants in the control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2584226|NCT02358031|Secondary|Pembro Combo vs Control: Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥20|"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 6 months is reported here out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥20 in the pembro combo arm and control arm. Per protocol, the percentage of participants with PFS at 6 months was compared separately between CPS ≥20 participants of the pembro mono arm and control arm and is presented later in the record."|Month 6|Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥20 were analyzed. 12 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2584227|NCT02358031|Secondary|Pembro Combo vs Control: Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among Participants With PD-L1 CPS ≥1|"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 6 months is reported here out of all participants with PD-L1 biomarker positive expression defined by IHC as CPS ≥1 in the pembro combo arm and control arm. Per protocol, the percentage of participants with PFS at 6 months was compared separately between CPS ≥1 participants of the pembro mono arm and control arm and is presented later in the record."|Month 6|Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥1 were analyzed. 20 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2605720|NCT02107014|Primary|Change in SCF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2584228|NCT02358031|Secondary|Pembro Combo vs Control: Percentage of Participants With PFS at 6 Months Per RECIST 1.1 by BICR Among All Participants|"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified secondary analysis of the ITT population. The percentage of participants with PFS (PFS rate) at 6 months is reported here out of all participants in the pembro combo arm and control arm. Per protocol, the percentage of participants with PFS at 6 months was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record."|Month 6|All participants in the ITT population randomized to either the pembro combo arm or control arm during active enrollment were analyzed. 22 participants in the control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.|||Percentage of Participants||95% Confidence Interval|Number
2584229|NCT02358031|Primary|Pembro Mono vs Control: OS in Participants With PD-L1 CPS ≥20|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro mono arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥20. Per protocol, OS was compared separately between CPS ≥20 participants of the pembro combo arm and control arm and is presented earlier in the record.|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥20 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2584230|NCT02358031|Primary|Pembro Mono vs Control: OS in Participants With PD-L1 CPS ≥1|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro mono arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥1. Per protocol, OS was compared separately between CPS ≥1 participants of the pembro combo arm and control arm and is presented earlier in the record.|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥1 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2584231|NCT02358031|Primary|Pembro Mono vs Control: OS in All Participants|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro mono arm and control arm. Per protocol, OS was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record.|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2584232|NCT02358031|Primary|Pembro Mono vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20|"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for all participants in the pembro mono arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥20. Per protocol, PFS was compared separately between CPS ≥20 participants of the pembro combo arm and control arm and is presented earlier in the record."|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥20 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2584233|NCT02358031|Primary|Pembro Mono vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1|"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for all participants in the pembro mono arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥1. Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro combo arm and control arm and is presented earlier in the record."|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment with CPS ≥1 were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2584267|NCT02357940|Primary|Percentage With Edema on the Arms at Day 7|Percentage of adults and babies with edema on the arms at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2605721|NCT02107014|Primary|Change in PIGF-1 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2584234|NCT02358031|Primary|Pembro Mono vs Control: PFS Per RECIST 1.1 by BICR in All Participants|"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro mono arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for all participants in the pembro mono arm and control arm. Per protocol, PFS was compared separately between all participants of the pembro combo arm and control arm and is presented earlier in the record."|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|All participants in the ITT population randomized to either the pembro mono arm or control arm during active enrollment were analyzed. Per protocol, pembro combo arm was compared to control arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2584235|NCT02358031|Primary|Pembro Combo vs Control: OS in Participants With PD-L1 CPS ≥20|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro combo arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥20. Per protocol, OS was compared separately between CPS ≥20 participants of the pembro mono arm and control arm and is presented later in the record.|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥20 were analyzed. 12 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2584236|NCT02358031|Primary|Pembro Combo vs Control: OS in Participants With PD-L1 CPS ≥1|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro combo arm and control arm with PD-L1 biomarker positive expression defined by IHC as CPS ≥1. Per protocol, OS was compared separately between CPS ≥1 participants of the pembro mono arm and control arm and is presented later in the record.|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥1 were analyzed. 20 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2584237|NCT02358031|Primary|Pembro Combo vs Control: Overall Survival (OS) in All Participants|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the ITT population. OS is reported here for all participants in the pembro combo arm and control arm. Per protocol, OS was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record.|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|All participants in the ITT population randomized to either the pembro combo arm or control arm during active enrollment were analyzed. 22 participants in the control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2584238|NCT02358031|Primary|Pembro Combo vs Control: PFS Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥20|"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for all participants in the pembro combo arm and control arm with PD-L1 biomarker positive expression defined by IHC as Combined Positive Score ≥20 (hereafter referred to as CPS ≥20). Per protocol, PFS was compared separately between CPS ≥20 participants of the pembro mono arm and control arm and is presented later in the record."|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥20 were analyzed. 12 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2584239|NCT02358031|Primary|Pembro Combo vs Control: PFS Per RECIST 1.1 by BICR in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1|"PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the ITT population. PFS is reported here for all participants in the pembro combo arm and control arm with PD-L1 biomarker positive expression defined by immunohistochemistry (IHC) as Combined Positive Score ≥1 (hereafter referred to as CPS ≥1). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro mono arm and control arm and is presented later in the record."|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|Participants in the ITT population randomized to either pembro combo arm or control arm during active enrollment with CPS ≥1 were analyzed. 20 participants in control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2584240|NCT02358031|Primary|Pembro Combo vs Control: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in All Participants|"PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.~Per protocol, PFS in the pembro combo arm was compared to the control arm as a pre-specified primary analysis of the Intent-To-Treat (ITT) population. PFS is reported here for all participants in the pembro combo arm and control arm. Per protocol, PFS was compared separately between all participants of the pembro mono arm and control arm and is presented later in the record."|Up to approximately 47 months (through Final Analysis cut-off date of 25-Feb-2019)|All participants in the ITT population randomized to either the pembro combo arm or control arm during active enrollment were analyzed. 22 participants in the control arm enrolled during an enrollment pause of the pembro combo arm were excluded. Per protocol, pembro mono arm was compared to control arm separately and not included in this analysis.|||Months||95% Confidence Interval|Median
2584241|NCT02357940|Primary|Percentage With Scaling on the Torso at Day 14|Percentage of adults and babies with scaling on the torso at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584242|NCT02357940|Primary|Percentage With Scaling on the Legs at Day 14|Percentage of adults and babies with scaling on the legs at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584243|NCT02357940|Primary|Percentage With Scaling on the Arms at Day 14|Percentage of adults and babies with scaling on the arms at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584244|NCT02357940|Primary|Percentage With Scaling on the Face at Day 14|Percentage of adults and babies with scaling on the face at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584245|NCT02357940|Primary|Percentage With Scaling on the Torso at Day 7|Percentage of adults and babies with scaling on the torso at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584246|NCT02357940|Primary|Percentage With Scaling on the Legs at Day 7|Percentage of adults and babies with scaling on the legs at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584247|NCT02357940|Primary|Percentage With Scaling on the Arms at Day 7|Percentage of adults and babies with scaling on the arms at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584248|NCT02357940|Primary|Percentage With Scaling on the Face at Day 7|Percentage of adults and babies with scaling on the face at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584249|NCT02357940|Primary|Percentage With Scaling on the Torso at Day 1|Percentage of adults and babies with scaling on the torso at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584250|NCT02357940|Primary|Percentage With Scaling on the Legs at Day 1|Percentage of adults and babies with scaling on the legs at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584251|NCT02357940|Primary|Percentage With Scaling on the Arms at Day 1|Percentage of adults and babies with scaling on the arms at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584252|NCT02357940|Primary|Percentage With Scaling on the Face at Day 1|Percentage of adults and babies with scaling on the face at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584253|NCT02357940|Primary|Percentage With Scaling on the Torso at Baseline After Investigational Product Application|Percentage of adults and babies with scaling on the torso at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584254|NCT02357940|Primary|Percentage With Scaling on the Legs at Baseline After Investigational Product Application|Percentage of adults and babies with scaling on the legs at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584255|NCT02357940|Primary|Percentage With Scaling on the Arms at Baseline After Investigational Product Application|Percentage of adults and babies with scaling on the arms at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584256|NCT02357940|Primary|Percentage With Scaling on the Face at Baseline After Investigational Product Application|Percentage of adults and babies with scaling on the face at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584257|NCT02357940|Primary|Percentage With Scaling on the Torso at Baseline Before Investigational Product Application|Percentage of adults and babies with scaling on the torso at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584268|NCT02357940|Primary|Percentage With Edema on the Face at Day 7|Percentage of adults and babies with edema on the face at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584269|NCT02357940|Primary|Percentage With Edema on the Torso at Day 1|Percentage of adults and babies with edema on the torso at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584270|NCT02357940|Primary|Percentage With Edema on the Legs at Day 1|Percentage of adults and babies with edema on the legs at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584271|NCT02357940|Primary|Percentage With Edema on the Arms at Day 1|Percentage of adults and babies with edema on the arms at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584272|NCT02357940|Primary|Percentage With Edema on the Face at Day 1|Percentage of adults and babies with edema on the face at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584273|NCT02357940|Primary|Percentage With Edema on the Torso at Baseline After Investigational Product Application|Percentage of adults and babies with edema on the torso at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584274|NCT02357940|Primary|Percentage With Edema on the Legs at Baseline After Investigational Product Application|Percentage of adults and babies with edema on the legs at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584275|NCT02357940|Primary|Percentage With Edema on the Arms at Baseline After Investigational Product Application|Percentage of adults and babies with edema on the arms at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584276|NCT02357940|Primary|Percentage With Edema on the Face at Baseline After Investigational Product Application|Percentage of adults and babies with edema on the face at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584277|NCT02357940|Primary|Percentage With Edema on the Torso at Baseline Before Investigational Product Application|Percentage of adults and babies with edema on the torso at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584278|NCT02357940|Primary|Percentage With Edema on the Legs at Baseline Before Investigational Product Application|Percentage of adults and babies with edema on the legs at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584279|NCT02357940|Primary|Percentage With Edema on the Arms at Baseline Before Investigational Product Application|Percentage of adults and babies with edema on the arms at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584280|NCT02357940|Primary|Percentage With Edema on the Face at Baseline Before Investigational Product Application|Percentage of adults and babies with edema on the face at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584281|NCT02357940|Primary|Percentage With Erythema on the Torso at Day 14|Percentage of adults and babies with erythema on the torso at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584282|NCT02357940|Primary|Percentage With Erythema on the Legs at Day 14|Percentage of adults and babies with erythema on the legs at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584283|NCT02357940|Primary|Percentage With Erythema on the Arms at Day 14|Percentage of adults and babies with erythema on the arms at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584284|NCT02357940|Primary|Percentage With Erythema on the Face at Day 14|Percentage of adults and babies with erythema on the face at Day 14|At Day 14|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584285|NCT02357940|Primary|Percentage With Erythema on the Torso at Day 7|Percentage of adults and babies with erythema on the torso at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584286|NCT02357940|Primary|Percentage With Erythema on the Legs at Day 7|Percentage of adults and babies with erythema on the legs at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584287|NCT02357940|Primary|Percentage With Erythema on the Arms at Day 7|Percentage of adults and babies with erythema on the arms at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584288|NCT02357940|Primary|Percentage With Erythema on the Face at Day 7|Percentage of adults and babies with erythema on the face at Day 7|At Day 7|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584289|NCT02357940|Primary|Percentage With Erythema on the Torso at Day 1|Percentage of adults and babies with erythema on the torso at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584290|NCT02357940|Primary|Percentage With Erythema on the Legs at Day 1|Percentage of adults and babies with erythema on the legs at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584291|NCT02357940|Primary|Percentage With Erythema on the Arms at Day 1|Percentage of adults and babies with erythema on the arms at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584292|NCT02357940|Primary|Percentage With Erythema on the Face at Day 1|Percentage of adults and babies with erythema on the face at Day 1|At Day 1|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584293|NCT02357940|Primary|Percentage With Erythema on the Torso at Baseline After Investigational Product Application|Percentage of adults and babies with erythema on the torso at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584294|NCT02357940|Primary|Percentage With Erythema on the Legs at Baseline After Investigational Product Application|Percentage of adults and babies with erythema on the legs at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584295|NCT02357940|Primary|Percentage With Erythema on the Arms at Baseline After Investigational Product Application|Percentage of adults and babies with erythema on the arms at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584296|NCT02357940|Primary|Percentage With Erythema on the Face at Baseline After Investigational Product Application|Percentage of adults and babies with erythema on the face at baseline after investigational product application|At baseline after investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584297|NCT02357940|Primary|Percentage With Erythema on the Torso at Baseline Before Investigational Product Application|Percentage of adults and babies with erythema on the torso at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584298|NCT02357940|Primary|Percentage With Erythema on the Legs at Baseline Before Investigational Product Application|Percentage of adults and babies with erythema on the legs at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584299|NCT02357940|Primary|Percentage With Erythema on the Arms at Baseline Before Investigational Product Application|Percentage of adults and babies with erythema on the arms at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584300|NCT02357940|Primary|Percentage With Erythema on the Face at Baseline Before Investigational Product Application|Percentage of adults and babies with erythema on the face at baseline before investigational product application|At baseline before investigational product application|The analysis was based on the intent-to-treat subjects who had data available at the specified time point.|||Percentage of participants|||Number
2584301|NCT02357901|Secondary|Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) From Week 2 - 24|The C-SSRS asks questions of study participants regarding whether they had suicidal ideation and/or suicidal behavior since the last visit using the electronic version of the scale. The C-SSRS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21.|Weekly - Week 2 through Week 24|Safety analysis set of participants who completed a C-SSRS during the treatment period.|||Participants|||Count of Participants
2584302|NCT02357901|Secondary|Worst Injection Site Pain From Injections 1-6 as Measured by Participant-Reported Visual Analog Scale (VAS)|"Injection site pain as measured by participant-reported VAS The participant-reported VAS for injection site pain was measured on a 100 mm scale with 'no pain' on the left end and 'strongest pain ever' on the right end of the scale (total scale of 0-100). Participants marked where along the scale reflected their localized injection pain.~The injection site pain VAS scores were obtained (after the completion of the injection) within 1 minute and at 5, 10, 15, 30, 60 and 120 minutes (+- 5 minutes). The timing of the injection site pain VAS should have been measured from the end of the injection.~Data represents the worst pain recorded for each participant across all 6 injections and all VAS records. The mean value is presented."|Days 1, 29, 57, 85, 113, 141|Safety population|||units on a scale||Standard Deviation|Mean
2584303|NCT02357901|Secondary|Participants With Adverse Events During the Treatment Period|Treatment-emergent adverse event (TEAE) = any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent one of the outcomes listed in this definition.|Day 1 through Week 24|Safety analysis set|||Participants|||Count of Participants
2584304|NCT02357901|Secondary|Total Number of Weeks of Abstinence as Assessed From Urine Samples Negative for Opioids Combined With Self-Reports Negative for Illicit Opioid Use Collected From Week 5 Through Week 24|The total number of weeks of abstinence was assessed from urine samples negative for opioids combined with self-reports negative for illicit opioid use collected from week 5 through week 24. All missing reports for opioids were considered non-negative.|Weeks 5 through 24|Full analysis set|||weeks||Standard Error|Least Squares Mean
2605722|NCT02107014|Primary|Change in TNF-β From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2584305|NCT02357901|Secondary|Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) Through Week 24 Analyzed by Mixed Model for Repeated Measures|"The Subjective Opiate Withdrawal Scale (SOWS) contains 16 symptoms whose intensity the participant rates on a scale of 0 (not at all) to 4 (extremely) for a full scale of 0 (no withdrawal symptoms) to 64 (extreme withdrawal symptoms). Negative change from baseline values indicate a lessening of withdrawal symptoms.~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. The SOWS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21.~Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate."|Baseline: Day 1 (prior to dosing), Baseline: Day 1 (prior to dosing), Days 2, 8, 5, 22, 29, 30, 36, 43, 50, 57, 58, 64, 71, 78, 85, 86, 92, 99, 106, 113, 114, 120, 127, 134, 141, 142, 148, 155, 162, 169|Full analysis set of participants who had available data on baseline score and change from baseline in any visit through week 24.|||units on a scale||Standard Error|Least Squares Mean
2584306|NCT02357901|Secondary|Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) Through Week 24 Analyzed by Mixed Model for Repeated Measures|"COWS is an 11-item instrument used to assess signs and symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderately severe withdrawal, and 37-48 severe withdrawal. Negative change from baseline values indicate a lessening of withdrawal symptoms.~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. The COWS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21.~Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate."|Baseline: Day 1 (prior to dosing), Baseline: Day 1 (prior to dosing), Days 2, 8, 5, 22, 29, 30, 36, 43, 50, 57, 58, 64, 71, 78, 85, 86, 92, 99, 106, 113, 114, 120, 127, 134, 141, 142, 148, 155, 162, 169|Full analysis set of participants who had available data on baseline score and change from baseline in any visit through week 24.|||units on a scale||Standard Error|Least Squares Mean
2584307|NCT02357901|Secondary|Change From Baseline in the Clinical Global Impression - Severity Scale (CGI-S) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures|"The CGI-S was an assessment completed by the clinician to rate the severity of symptoms on an ordinal scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects; pathology drastically interferes in many life functions). Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Measurements taken during the treatment period were taken at the end of each 28 day treatment and prior to dosing of the next treatment.~Negative change from baseline values indicate an improvement in the severity of symptoms.~Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect."|Baseline: Day 1 (prior to dosing), Days 29, 57, 85, 113, 141, 169|Full analysis set of participants who had available data on baseline score and change from baseline in any visit through week 24.|||units on a scale||Standard Error|Least Squares Mean
2584308|NCT02357901|Secondary|Change From Baseline in the Clinical Global Impression - Improvement Scale (CGI-I) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures|"The CGI-I was used to rate the change in clinical status since the start of the treatment on an ordinal scale ranging from 1 (very much improved; nearly all better; good level of functioning; minimal symptoms; represents a very substantial change) to 7 (very much worse; severe exacerbation of symptoms and loss of functioning). Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. Measurements taken during the treatment period were taken at the end of each 28 day treatment and prior to dosing of the next treatment.~Negative change from baseline values indicate an improved clinical global impression.~Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect."|Baseline: Day 1 (prior to dosing), Days 29, 57, 85, 113, 141, 169|Full analysis set of participants who had available data on baseline score and change from baseline in any visit through week 24.|||units on a scale||Standard Error|Least Squares Mean
2584309|NCT02357901|Secondary|Participants Who Are Abstinent at Week 24|Participants with both a negative urine sample and negative self-report for illicit opioid use at Week 24.|Week 24|Full analysis set|||Participants|||Count of Participants
2584310|NCT02357901|Secondary|"Participants Who Complete the Week 24 Visit (Completers)"|A completer was defined as a participant who completed either the urine drug screen (UDS) or Timeline Followback (TLFB) assessment at the Week 24 visit.|Week 24|Full analysis set|||Participants|||Count of Participants
2584311|NCT02357901|Secondary|Change From Baseline in the Opioid Craving Visual Analog Scale (VAS) Prior to Injections From Week 5 Through Week 24 Analyzed by Mixed Model for Repeated Measures|"The opioid craving scale was a 100 mm scale with 0= 'no craving' on the left end and 100= 'strongest craving ever' on the right end of the scale. Participants marked where along the scale reflected their craving for opioids. The full range of the change from baseline scale was therefore 100 (no craving at baseline, strongest craving during study) to -100 (strongest craving at baseline, no craving during study).~Baseline was defined as the last non-missing value prior to subcutaneous injection on Day 1. The opioid craving VAS was completed each week; measurements were taken prior to dosing on weeks 5, 9, 13, 17 and 21.~Negative change from baseline values indicate a lessening of craving symptoms.~Change from baseline was analyzed using a mixed model for repeated measures (MMRM) with terms for treatment, visit, and treatment-by-visit interaction as factors and baseline value as a covariate. Center was included in the model as a random effect."|Baseline: Day 1 (prior to dosing), Weeks 5-24|Full analysis set of participants who had available data on baseline score and change from baseline in any visit through week 24.|||units on a scale||Standard Error|Least Squares Mean
2584348|NCT02357485|Secondary|Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion|Comparison of baseline measure of knee flexion to 3 months measurements of knee flexion. An increase in range of motion is positive (improved ability to move) and a decrease in range of motion is negative.|Baseline to 3 months||||degrees|Participants|Standard Deviation|Mean
2584312|NCT02357901|Secondary|Cumulative Distribution Function (CDF) of the Percentage of Self-Reports Negative for Illicit Opioid Use From Week 5 Through Week 24|Data represent the count of participants at various percentage levels in which self-reports were negative for illicit use of opioids. Self-reports were obtained from Timeline Followback (TLFB) interviews. All missing self-reports were considered non-negative.|Weekly from Weeks 5-24|Full analysis set|||Participants|||Count of Participants
2584313|NCT02357901|Secondary|Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opioids From Week 5 Through Week 24|Data represent the count of participants at various percentage levels in which urine samples tested negative for opioids. All missing reports for urine samples were considered non-negative.|Weekly from Weeks 5-24|Full analysis set|||Participants|||Count of Participants
2584314|NCT02357901|Secondary|Percentage of Participants Considered A Treatment Success|Treatment success is defined as a participant having ≥80% of urine samples negative for opioids combined with self-reports negative for illicit opioid use between weeks 5-24.|Weeks 5-24|Full analysis set|||percentage of participants|||Number
2584315|NCT02357901|Primary|Cumulative Distribution Function (CDF) of the Percentage of Urine Samples Negative for Opioids Combined With Self-Reports Negative for Illicit Opioid Use Collected From Week 5 Through Week 24|Data represent the count of participants at various percentage abstinence levels. Abstinence was defined as urine samples being negative for opioids AND negative self-reports (obtained from Timeline Followback (TLFB) interviews) for illicit opioid use. The primary endpoint was based on visits in which paired urine samples and self-reports were expected for each subject as specified in the schedule of events. Missing urine drug screen(s) (UDS) samples and/or self-reports were considered as non-negative.|Weekly from Weeks 5-24|Full analysis set|||Participants|||Count of Participants
2584316|NCT02357758|Secondary|Changes in Pro-inflammatory Cytokines|Changes in pro-inflammatory cytokines associated with inflammation and immune cell recruitment will be measured using multiplexed immunoassay kits employing Luminex® xMAP fluorescent beadbased technology.|Baseline, 3-, 6-, 9-, 12-months|||||||
2584317|NCT02357758|Secondary|Changes to Antibiotic Susceptibility|Changes to antibiotic susceptibility of cultured bacteria as determined by the Kirby Bauer disc diffusion method.|Baseline, 3-, 6-, 9-, 12-months|||||||
2584318|NCT02357758|Secondary|Changes to Metabolic Profiles of Urine|Changes to metabolic profiles of urine as determined using gas chromatography mass spectrometry (GC-MS).|Baseline, 3-, 6-, 9- 12-months|||||||
2584319|NCT02357758|Primary|Changes to the Urinary Microbiota|Changes to the urinary microbiota were measured as changes in the colony forming units (CFUs) of Enterococcus sp., Escherichia coli, Klebsiella sp./Enterobacter sp., Staphylococcus saprophyticus, or Pseudomonas sp./Staphylococcus aureus when the participant urine was cultured on CHROMagar Orientation. The data was analyzed in terms of bacterial counts, presence/absence, and presence at or above the diagnostic threshold for UTI (10^5 CFU/mL of one species). Here we present participant midstream urine samples that met the diagnostic threshold for UTI at baseline.|Baseline, 3-, 6-, 9-, 12-months|Bacterial culture data was not available for all participants due to the low volume of some samples.|||participants|||Number
2584320|NCT02357706|Secondary|Mean O2 Saturation|Mean blood oxygen Saturation, %|1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B||||% total hemoglobin||Standard Deviation|Mean
2584321|NCT02357706|Secondary|Flow Limitation (%)|Percent of flow-limited breaths in relation to the overall breaths at night.|1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B||||% overall breaths||Standard Deviation|Mean
2584322|NCT02357706|Secondary|Respiratory Effort Related Arousals RERAs|Number of RERAs per hour of nights sleep, Events/hour|1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B||||events/hour||Standard Deviation|Mean
2584323|NCT02357706|Secondary|Hypopnoea-Index HI|Number of Hypopnoeas per hour of nights sleep, Events/hour|1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B||||events/hour||Standard Deviation|Mean
2584324|NCT02357706|Secondary|Mixed Apnoea Index (MAI)|Number of obstructive and central apnoeas per hours of nights sleep, Events/hour|1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B||||events/hour||Standard Deviation|Mean
2584325|NCT02357706|Secondary|Central Apnoea Index (CAI)|Number of central apnoeas during hours of sleep, events/hour|1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B||||events/hour||Standard Deviation|Mean
2584326|NCT02357706|Secondary|Obstructive Apnoea Index (OAI)|Number of obstructive apnoeas per hour of nights sleep, Events/hour|1 night (446 minutes) for APAP A; 1 night (436 minutes) for APAP B||||events/hour||Standard Deviation|Mean
2584327|NCT02357706|Primary|Mean Oxygen Desaturation Index (ODI)|Number of times that Oxygen Level Drops by 3% below baseline value, Events/hour|1 night (446 minutes) for APAP A, 1 night (436 minutes) for APAP B.||||events/hour||Standard Deviation|Mean
2584328|NCT02357706|Primary|Mean Apnoea-Hypopnoea-Index (AHI)|AHI measures the number of apnoeas + hypopnoeas per hours of night (events/hour).|1 night (446 minutes) for APAP A (AirSense), 1 night (436 minutes) for APAP B (Apex)|20 patients have used APAP A, for which the primary outcome was calculated. The same 20 patients have used APAP B for which the Primary outcome was calculated.|||events/hour||Standard Deviation|Mean
2584329|NCT02357576|Secondary|Behavioral Assessment System for Children-Second Edition (BASC2)|Primary measurements from the BASC-2 including the Adaptive Behavior Composite and the Behavior Symptoms Index will be reported as T-scores and as percentiles. Secondary analyses will be conducted on the subscales.|2 years|||||||
2584330|NCT02357576|Secondary|Gross Motor Function Classification System (GMFCS)|This classification is based on observation with a scale of 1-5|2 years|||||||
2584331|NCT02357576|Secondary|Brief Infant Toddler Social Emotional Assessment (BITSEA)|Dichotomous scores are generated based on cut-off scores, which identify subjects to be at risk. Internal consistency coefficients range from.80 to.82. Test-retest reliability is acceptable at .80-.85. Recent evidence identifies the BITSEA as the best short tool for early detection of psychosocial problems in two-year olds.|2 years|||||||
2584332|NCT02357576|Secondary|MacArthur-Bates Communicative Development Inventories (CDI)|Scores are reported as percentiles compared to age-standardized norms.|2 years|||||||
2584333|NCT02357576|Secondary|Bayley Scales for Infant and Toddler Development (BSID-III) at Two Years|Raw scores are converted to composite and subscale scores using age-standardized norms. Scale composite average internal consistency reliability coefficients range from .91 to .93 with subtest reliability ranging from .86 to .91.|2 years|||||||
2584334|NCT02357576|Secondary|Bayley Scales for Infant and Toddler Development (BSID-III) at One Year|The Bayley Scales of Infant and Toddler Development (BSID-III) is designed to assess developmental functioning of infants and toddlers, ages 1 month to 42 months. The instrument includes five distinct scales, of which three scales and associated subscales are utilized for the purposes of this study: cognitive, language (receptive and expressive communication) and motor (fine motor and gross motor). Raw scores are converted to scaled scores using age-standardized norm. The cognitive scaled scores range from 1-19. 1 is a low score and 19 is a high score. The Language scaled scores are calculated by adding the Receptive Communication scores ranging from 1-19 and the Expressive communication scores ranging from 1-19 to give the Language Scaled score of 2-38. The Motor scaled scores are calculated by adding the Fine Motor scores ranging from 1-19 and the Gross Motor scores ranging from 1-19 to give the Motor scaled ranging from 2-38. Higher scores are better than lower scores.|1 year|Participants who returned for their one year follow up|||scores on a scale||Full Range|Median
2584335|NCT02357576|Secondary|Adverse Events, as Defined by Any Episode of Sepsis and Catheter-related Blood Stream Infections|The number of episodes were compared between the standard and reduced lipid groups of suspected sepsis episodes, NEC, or catheter-related blood stream infections.|12 weeks|Subjects who experienced an episode of suspected sepsis, catheter-related blood stream infection, or NEC|||episodes|||Number
2584336|NCT02357576|Secondary|Adequacy of Growth as Evaluated by Z-scores for Head Circumference|Z-scores were compared between subjects in the two treatment groups. Z-scores are the number of standard deviations above (positive value) or below (negative value) the median on the FENTON and WHO growth charts. Fenton scores were used for infants born <37 weeks gestation. WHO scores were used for infants born at ≥37 weeks gestation.|12 weeks|"All subjects aside from the screen fail. Z-scores were recorded while subjects were on treatment which meant that they were recorded until 7 days after parenteral nutrition (PN) had been discontinued, but not to exceed 12 weeks for subjects still on PN. This is why the participants analyzed each week is a different number and decreasing with time"|||z-score||Full Range|Median
2584337|NCT02357576|Secondary|Adequacy of Growth as Evaluated by Z-scores for Height|Z-scores were compared between subjects in the two treatment groups. Z-scores are the number of standard deviations above (positive value) or below (negative value) the median on the FENTON and WHO growth charts. Fenton scores were used for infants born <37 weeks gestation. WHO scores were used for infants born at ≥37 weeks gestation.|12 weeks|"All subjects aside from the screen fail. Z-scores were recorded while subjects were on treatment which meant that they were recorded until 7 days after parenteral nutrition (PN) had been discontinued, but not to exceed 12 weeks for subjects still on PN. This is why the participants analyzed each week is a different number and decreasing with time"|||z-score||Full Range|Median
2584338|NCT02357576|Secondary|Adequacy of Growth as Evaluated by Z-scores for Weight|Z-scores were compared between subjects in the two treatment groups by week. Z-scores are the number of standard deviations above (positive value) or below (negative value) the median on the FENTON and WHO growth charts. Fenton scores were used for infants born <37 weeks gestation. WHO scores were used for infants born at ≥37 weeks gestation.|12 weeks|"All subjects aside from the screen fail. Z-scores were recorded while subjects were on treatment which meant that they were recorded until 7 days after parenteral nutrition (PN) had been discontinued, but not to exceed 12 weeks for subjects still on PN. This is why the participants analyzed each week is a different number and decreasing with time"|||z-score||Full Range|Median
2584339|NCT02357576|Secondary|The Prevalence of Essential Fatty Acid Deficiency (EFAD)|The number of participants who experienced EFAD was compared between the standard and reduced lipid groups.|12 weeks|All patients in the reduced lipid group were analyzed. The standard lipid group had essential fatty acid profile drawn for one patient as not all patients in the standard group required the essential fatty acid profile to be drawn.|||Participants|||Count of Participants
2584340|NCT02357576|Secondary|Peak Direct Bilirubin Level|The peak (highest) direct bilirubin collected from each subject from after week 1 to end of treatment. This was compared between the standard and reduced lipid groups.|12 weeks|Subjects with direct bilirubin values collected after 1 week|||mg/dL||Full Range|Median
2584341|NCT02357576|Secondary|Peak Total Bilirubin Level|The peak (highest) total bilirubin collected from each subject from after week 1 to end of treatment. This was compared between the standard and reduced lipid groups.|12 weeks|Subjects with total bilirubin values collected after 1 week|||mg/dL||Full Range|Median
2584342|NCT02357576|Secondary|The Time to Development of Severe PNAC|The time to development from randomization was compared between the standard and reduced lipid groups.|12 weeks|Subjects who developed severe PNAC as defined by a direct bilirubin value of 4 mg/dL or greater|||Days|||Number
2584343|NCT02357576|Secondary|The Time to Development of PNAC|The time to development was compared between the standard and reduced lipid groups.|12 weeks|Only the subjects that developed PNAC were analyzed|||days||Full Range|Median
2584344|NCT02357576|Secondary|Prevalence of Severe Parenteral Nutrition-associated Cholestasis (PNAC) (Direct Bilirubin ≥4 mg/dL in Subjects on Parenteral Nutrition for at Least 2 Weeks)|The number of participants with severe PNAC defined as a direct bilirubin ≥4 mg/dL were compared between the standard and reduced lipid groups. Bilirubin data was collected from baseline until 7 days after PN has been discontinued, but not to exceed a total of 12 weeks.|12 weeks|Analyzable data was not available for one participant in the Reduced Lipid Arm|||Participants|||Count of Participants
2584345|NCT02357576|Secondary|Prevalence of Parenteral Nutrition-associated Cholestasis (PNAC) (Direct Bilirubin ≥2 mg/dL)|The number of participants who had a direct bilirubin ≥2 mg/dL were compared between the standard and reduced lipid groups. Bilirubin data was collected from baseline until 7 days after PN has been discontinued, but not to exceed a total of 12 weeks.|12 weeks|Analyzable data was not available for one participant in the Reduced Lipid Arm|||Participants|||Count of Participants
2584346|NCT02357576|Primary|Rate of Rise of Direct Bilirubin as a Function of Time|The rate of rise (change over time) of direct bilirubin was compared between the two groups at different time points.|12 weeks|Analyzable data was not available for one participant in the Reduced Lipid Arm|||mg/dL/day||95% Confidence Interval|Number
2584347|NCT02357485|Secondary|Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG).|Comparison of baseline time for subjects' ability to rapidly rise from a chair, move rapidly 2 meters from the chair, turn and return and sit in the chair to the same measure at 3 months. Time to complete task is measured in seconds.|baseline to 3 months||||seconds||Standard Deviation|Mean
2584349|NCT02357485|Secondary|Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain|Comparison of VAS pain score as measured before treatment and 3 months and 1 year after treatment. VAS measured on a scale of 0 (no pain) to 10 (worst possible pain).|Baseline to 1 year||||units on a scale|Participants|Standard Deviation|Mean
2584350|NCT02357485|Secondary|Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|"Comparison of WOMAC score (pain, stiffness and functionality measures) measured at baseline (pre-treatment), 3 months and 1 year (post treatment).~WOMAC score: 0 (best) to 100 (worst)"|Baseline to 1 year||||units on a scale|Participants|Standard Deviation|Mean
2584351|NCT02357485|Primary|Safety as Measured by Adverse Events|Adverse Events were recorded during the entirety of the study.|Entire Study (1 year)|All 6 participants were included in the analysis|||percentage of participants|||Number
2584352|NCT02357459|Other Pre-specified|Average Weekly and Total Consumption of Rescue Medications at Each Week (Weeks 1-24)||Weeks 1-24||||tablets (1 tablet = 500 mg)||Standard Error|Least Squares Mean
2584353|NCT02357459|Other Pre-specified|Time to Onset of Pain Relief|Time to onset of pain relief is defined as the time from administration of study drug to the first daily pain assessment showing >30% improvement from the weekly mean of the ADP scores at baseline|Baseline to >30% improvement (measured up to 30 days)||||days||95% Confidence Interval|Median
2584354|NCT02357459|Other Pre-specified|Responder Status as Defined by Proportion of Patients Experiencing >50% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)||Weeks 1-24||||Participants|||Count of Participants
2584355|NCT02357459|Other Pre-specified|Responder Status as Defined by Proportion of Patients Experiencing >30% Decrease in Pain From Baseline in Weekly Mean of the ADP Scores at Each Week (Weeks 1-24)|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|Weeks 1-24||||Participants|||Count of Participants
2584356|NCT02357459|Other Pre-specified|Change From Baseline Over Time for Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QOL) Subscale at Weeks 4, 8, 12 and 24|"The Knee injury and Osteoarthritis Outcome Score (KOOS) is a participant (patient)-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury and also consequences of primary osteoarthritis (OA). It holds 42 items in five separately scored subscales: KOOS Pain, KOOS Symptoms, Function in daily living (KOOS ADL), Function in Sport and Recreation (KOOS Sport/Rec), and knee-related Quality of Life (KOOS QOL).~A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems). Each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as is common in orthopaedic assessment scales and generic measures. Higher scores indicate better quality of life."|Weeks 4, 8, 12, and 24||||units on a scale||Standard Error|Least Squares Mean
2584357|NCT02357459|Other Pre-specified|Change From Baseline Over Time for WOMAC C (Function Subscale) at Weeks 4, 8, 12, 16, 20 and 24|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|Weeks 4, 8, 12, 16, 20 and 24||||units on a scale||Standard Error|Least Squares Mean
2584358|NCT02357459|Other Pre-specified|Change From Baseline Over Time for WOMAC B (Stiffness Subscale) at Weeks 4, 8, 12, 16, 20 and 24|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|Weeks 4, 8, 12, 16, 20 and 24||||units on a scale||Standard Error|Least Squares Mean
2584359|NCT02357459|Other Pre-specified|Change From Baseline Over Time for WOMAC A (Pain Subscale) at Weeks 4, 8, 12, 16, 20 and 24.|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|Weeks 4, 8, 12, 16, 20, and 24||||units on a scale||Standard Error|Least Squares Mean
2584360|NCT02357459|Other Pre-specified|Change From Baseline to Each Week in Weekly Mean of the ADP Scores|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine."|Weeks 1-11 & Weeks 13-24||||units on a scale||Standard Error|Least Squares Mean
2584361|NCT02357459|Secondary|AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for FX006 Relative to Placebo|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine."|Baseline to 24 Weeks|AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 24 for TCA IR 40 mg Relative to Placebo was not a pre-specified Secondary Outcome and therefore not reported|||ADP Pain Scores * Week||Standard Error|Least Squares Mean
2584362|NCT02357459|Secondary|Change From Baseline to Week 12 in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine."|Baseline through 12 Weeks||||units on a scale||Standard Error|Least Squares Mean
2584363|NCT02357459|Secondary|AUE of Change From Baseline in Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to TCA IR|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine."|Baseline to 12 Weeks||||ADP Pain Scores * Week||Standard Error|Least Squares Mean
2584381|NCT02357394|Secondary|Admission to Neonatal Intensive Care Unit|Number of babies admitted to neonatal intensive care unit after birth during the same hospital stay.|participants will be followed for the duration of hospital stay, up to 17 weeks after delivery||||Participants|||Count of Participants
2584364|NCT02357459|Secondary|Area Under the Effect Curve (AUE) of Change From Baseline in the Weekly Mean of the ADP Scores From Baseline to Week 12 for FX006 Relative to Placebo|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine."|Baseline to 12 Weeks|Randomized patients who received study drug assigned to the FX006 32 mg arm and the placebo arm|||ADP Pain Scores * Week||Standard Error|Least Squares Mean
2584365|NCT02357459|Primary|Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain (ADP) Intensity Scores for 32 mg FX006 Versus Placebo|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where ) indicates no pain and 10 indicates pain as bad as you can imagine."|Baseline and 12 Weeks|Randomized patients who received study drug assigned to the FX006 32 mg arm and the placebo arm.|||units on a scale||Standard Error|Least Squares Mean
2584366|NCT02357420|Secondary|Change From Baseline to Week 12 for Gastric Emptying (GE) as Measured by the Gastric Emptying Breath Test (GEBT) Half-time|GE was measured via the GEBT and was reported as a time to half (t1/2) of the theoretical total GE. GEBT is a non-radioactive stable isotope breath test intended for measurement of GE of solids in participants. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Week 12|FAS included all randomized participants who received at least 1 dose of study treatment and provided at least 1 postbaseline primary efficacy measurement (DGSSD). Number analyzed is the number of participants with data available at the given time-point.|||minutes||Standard Deviation|Mean
2584367|NCT02357420|Secondary|Change From Baseline to Week 12 in Weekly DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal Pain)|"The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of DG (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and the frequency of vomiting episodes. Severity of nausea, bloating and abdominal pain, were assessed on a numerical rating scale of 0 to 10, with 0 equating to no (symptom) and 10 equating to worst possible (symptom). Early satiety was assessed on a 5-item scale with 1 being Only 1 or 2 bites and 5 being All of a normal-sized meal; symptom severity scores for this item were reversed and normalized to a range 0 to 10 for the development of the DGSSD 4-symptom Composite Score. The DGSSD 4-symptom Composite Score (Nausea, Bloating, Early Satiety, Abdominal pain) range is 0 to 40. Higher scores indicate worse condition. Weekly scores were averaged across 12 weeks period. A negative change from Baseline indicates improvement."|7 days prior to Day 1 for Baseline to 7 days prior to Week 12|FAS included all randomized participants who received at least 1 dose of study treatment and provided at least 1 postbaseline primary efficacy measurement (DGSSD). Number analyzed is the number of participants with data available at the given time-point.|||score on a scale||Standard Deviation|Mean
2584368|NCT02357420|Primary|Change From Baseline to Week 12 in Weekly Vomiting Episodes|Vomiting episodes were assessed via the Diabetic Gastroparesis Symptoms Severity Diary (DGSSD). The DGSSD is a 7-item, participant-reported daily diary designed to assess the severity of 6 core signs and symptoms of Diabetic Gastroparesis (DG) (nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) and the frequency of vomiting episodes. Each day, the participant recorded the number of vomiting episodes in the past 24 hours in the diary. Higher scores indicate more vomiting episodes. Weekly scores were averaged across the 12 weeks period. A negative change from Baseline indicates improvement.|7 days prior to Day 1 for Baseline to 7 days prior to Week 12|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study treatment and provided at least 1 postbaseline primary efficacy measurement (DGSSD). Number analyzed is the number of participants with data available at the given time-point.|||vomiting episodes per week||Standard Deviation|Mean
2584369|NCT02357394|Secondary|Cesarean Delivery|Number of participants that underwent cesarean delivery|at time of delivery, expected to be within 4 weeks of due date||||Participants|||Count of Participants
2584370|NCT02357394|Secondary|Preterm Premature Rupture of Membranes|Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.|participants will be followed for the duration of pregnancy, up to nine months||||Participants|||Count of Participants
2584371|NCT02357394|Secondary|Vaginal Bleeding|Number of participants who experienced bleeding from lower genital tract during antepartum period|participants will be followed for the duration of pregnancy, up to nine months||||Participants|||Count of Participants
2584372|NCT02357394|Secondary|Chorioamnionitis|Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.|participants will be followed for the duration of pregnancy, up to nine months||||Participants|||Count of Participants
2584373|NCT02357394|Secondary|Use of Antenatal Steroids|Number of participants that received betamethasone or dexamethasone to reduce morbidity of expected preterm delivery|participants will be followed for the duration of pregnancy, up to nine months||||Participants|||Count of Participants
2584374|NCT02357394|Secondary|Use of Tocolysis|Number of participants required use of tocolytic medication|participants will be followed for the duration of pregnancy, up to nine months||||Participants|||Count of Participants
2584375|NCT02357394|Secondary|Gestational Age at Delivery|Number of weeks of gestation completed by time of delivery|at time of birth, expected to be within 4 weeks of due date||||weeks||Full Range|Mean
2584376|NCT02357394|Secondary|Birthweight < 2500 Grams|Number of newborns whose birthweight is less than 2500 grams|at time of birth, expected to be within 4 weeks of due date||||Participants|||Count of Participants
2584377|NCT02357394|Secondary|Birthweight < 1500 Grams|Number of newborns whose birthweight is less than 1500 grams|at time of birth, expected to be within 4 weeks of due date||||Participants|||Count of Participants
2584378|NCT02357394|Secondary|Retinopathy of Prematurity Requiring Treatment|Number of newborn with Retinopathy of Prematurity that requires intervention.|participants will be followed for the duration of hospital stay, up to 17 weeks after delivery||||Participants|||Count of Participants
2584379|NCT02357394|Secondary|Duration of Ventilator Support|Number of days a baby requires use of mechanical ventilation|participants will be followed for the duration of hospital stay, up to 17 weeks after delivery||||days||Full Range|Mean
2584380|NCT02357394|Secondary|Total Days in the Neonatal Intensive Care Unit|Number of days a baby spends in the neonatal intensive care unit|participants will be followed for the duration of hospital stay, up to 17 weeks after delivery||||days||Full Range|Mean
2584383|NCT02357394|Secondary|Neonatal Composite Morbidity|Count of Fetal or Neonatal death up to 28 days after birth, respiratory distress syndrome, chronic lung disease, periventricular lucency, periventricular leukomalacia, intraventricular hemorrhage grade 3 or 4, necrotizing enterocolitis, early-onset-culture-proven sepsis|antepartum and up to 28 days after postnatal gestational age of 36 weeks||||Participants|||Count of Participants
2584384|NCT02357394|Secondary|Preterm Birth Before 34 Weeks|Number of deliveries before 34 weeks 0 days of gestation|up to 34 weeks 0 days||||Participants|||Count of Participants
2584385|NCT02357394|Primary|Preterm Birth Before 37 Weeks|Preterm birth refers to pregnancies that deliver before 37 weeks. Count of participants that deliver before they reach 37 weeks.|Up to 37 weeks 0 days||||Participants|||Count of Participants
2584386|NCT02357342|Secondary|Visual Acuity (Best Corrected Visual Acuity)|number of subjects with gain of 5 or more letters of visual acuity|baseline to 6 months||||participants||100% Confidence Interval|Number
2584387|NCT02357342|Primary|Visual Acuity|number of subjects with gain of 0-4 letters of visual acuity|Baseline to 6 months||||Participants|||Count of Participants
2584388|NCT02357342|Primary|Change in Edema From Baseline to Month 6 Central Subfield Thickness ) on Heidelberg Optical Coherence Topography|Change in edema from baseline to month 6 as measured by mean difference in microns of central subfield thickness on Heidelberg optical coherence topography in each treatment group|Baseline to 6 months||||microns||Full Range|Mean
2584389|NCT02357290|Secondary|Mean Change in the Children's Depression Rating Scale (CDRS) Score|The Children's Depression Rating Scale (CDRS) is a clinician-rated instrument with 17 items scored on a 1 to 5 or 1 to 7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. Scores of 20-30 suggest borderline depression. Scores of 40-60 indicate moderate depression.|Baseline and Endpoint (12 weeks or last observation carried forward if dropped prior to week 12)||||score on a scale||Standard Deviation|Mean
2584390|NCT02357290|Primary|Mean Change in the Young Mania Rating Scale (YMRS) Score|The Young Mania Rating Scale (YMRS) consists of 7 items rated on a scale from 0 (symptoms not present) to 4 (symptoms extremely severe) and 4 items rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe).The YMRS score ranges from 0-60. Questions are asked about the last week. A higher score signifies more severe manic symptoms.|Baseline and Endpoint (12 weeks or last observation carried forward if dropped prior to week 12)||||score on a scale||Standard Deviation|Mean
2584391|NCT02357264|Primary|Detection of Fluid in the Lungs|Detection of Fluid in the lungs in patients with pre-eclampsia vs. pregnant patients without pre-eclampsia|24-36 weeks||||Participants|||Count of Participants
2584392|NCT02357173|Primary|Point Prevalence Abstinence|% of participants with CO-verified cigarette abstinence at study week 16|week 16||||percentage of participants|||Number
2584393|NCT02357173|Primary|% Quit Attempts|% of participants who made any quit attempt during study|study enrollment to study week 16||||percentage of participants|||Number
2584394|NCT02357173|Primary|Independent Purchase of an ENDs Product|% of participants by group who purchased an ENDs product on their own during the study|study enrollment to study week 16||||percentage of participants|||Number
2584395|NCT02357173|Primary|Uptake of Electronic Nicotine Delivery Systems (ENDS)|% of participants by group used e-cigarettes in week 16|study week 16||||percentage of participants|||Number
2584396|NCT02357147|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs included both non-SAEs and SAEs and the same participant can have both SAEs and as well non-SAEs.|Baseline up to 3 years|The safety analysis set was defined as all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2584397|NCT02356900|Primary|Muscle Phenotype Change|Immunofluorescence microscopy using citrate synthase staining|Baseline/24 hrs Post-training|Muscle Biopsy samples were not analyzed due to funding issues.||||||
2584398|NCT02356900|Primary|COX-I Gene Expression Change|Real-time PCR|Baseline/24 hrs Post-training|Muscle Biopsy samples were not analyzed due to funding issues.||||||
2584399|NCT02356900|Primary|Pgc-1a Coactivator Muscle Protein Content Change|Western analysis|Baseline/24 hrs Post-training|Muscle Biopsy samples were not analyzed due to funding issues.||||||
2584400|NCT02356900|Primary|Tfam Muscle Protein Content Change|Western analysis|Baseline/24 hrs Post-training|Muscle Biopsy samples were not analyzed due to funding issues.||||||
2584401|NCT02356900|Primary|Mitochondrial Mass Change|Immunofluorescence microscopy using citrate synthase staining|Baseline/24 hrs Post-training|Muscle Biopsy samples were not analyzed due to funding issues.||||||
2584402|NCT02356900|Primary|Change in Ventilatory Threshold (VT) From Baseline to Post-training (<72 Hours)|Graded exercise test to exhaustion at simulated 15000 ft altitude|Baseline and <72 hrs Post-training|Three participants in the Hyperoxic, Hyperbaric group and one participant in the Normoxic, Normobaric group were not included in the analysis due to experimental errors.|||mL/kg/min||Standard Deviation|Mean
2584403|NCT02356900|Primary|Change in Maximum Aerobic Capacity (VO2max) From Baseline to Post-training (< 72 Hours )|Graded exercise test to exhaustion at simulated 15000 ft altitude|Baseline and <72 hrs Post-training|Three participants in the Hyperoxic, Hyperbaric group and one participant in the Normoxic, Normobaric group were not included in the analysis due to experimental errors.|||mL/kg/min||Standard Deviation|Mean
2584404|NCT02356783|Primary|Percentage of Patients With Available Step Count Data Post-procedure.|Percentage of patients with available step count data 60 days post-procedure. Step count will be obtained using a wireless pedometer daily for a period of 60 days post-procedure.|Duration of 60 days after procedure.||||percentage of patients with step data|||Number
2584405|NCT02356783|Primary|Percentage of Patients With Available Step Count Data at Baseline.|Percentage of patients with available step count data 7 days pre-procedure. Step count will be obtained daily for 7 days using a wireless pedometer.|A week pre-procedure.||||percentage of patients with step data|||Number
2584406|NCT02356588|Secondary|Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population||Cumulative through 24 hours||||mean number of doses used||Standard Deviation|Mean
2584407|NCT02356588|Secondary|Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population||Cumulative through 12 hours||||mean number of doses used||Standard Deviation|Mean
2584408|NCT02356588|Secondary|Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population||Cumulative through 6 hours||||mean number of doses used||Standard Deviation|Mean
2584411|NCT02356588|Secondary|Summed Pain Intensity Difference|"The SPID-1 is calculated by summing the difference to baseline between baseline pain score and the pain score at each assessment time point through 1 hour.~The observed SPID scores ranged from -2.00 to 5.25 in the active group to -4.90 to 3.00 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity."|1 hour||||units on a scale||Standard Error|Least Squares Mean
2584412|NCT02356588|Secondary|Healthcare Professional Global Assessment|Proportion of Health Care Professionals who responded good or excellent to the global assessment of method of pain control at 24 hours|24 hours||||Percentage of HCPs||95% Confidence Interval|Number
2584413|NCT02356588|Secondary|Patient Global Assessment|Proportion of patients who responded good or excellent to the global assessment of method of pain control at 24 hours|24 hours||||Percentage of patients||95% Confidence Interval|Number
2584414|NCT02356588|Secondary|Time-weighted SPRID24|Time-weighted summed pain relief intensity difference (SPRID) over the 24 hour study period. The observed SPRID scores ranged from -49.67 to 222.04 in the active group and -24.97 to 237.54 in the placebo group. A negative score indicates an increase in pain intensity and decrease in pain relief, while a higher score indicates a greater decrease in pain intensity and increase in pain relief.|24 hours||||units on a scale||Standard Error|Least Squares Mean
2584415|NCT02356588|Secondary|Time-weighted SPRID12|Time-weighted summed pain relief intensity difference (SPRID) over the 12 hour study period. The observed SPRID scores ranged from -38.08 to 106.82 in the active group and -20.10 to 95.72 in the placebo group. A negative score indicates an increase in pain intensity and decrease in pain relief, while a higher score indicates a greater decrease in pain intensity and increase in pain relief.|12 hours||||units on a scale||Standard Error|Least Squares Mean
2584416|NCT02356588|Secondary|TOTPAR24|Total pain relief over the 24 hour study period. The observed total pain relief scores ranged from 12.35 to 95.23 in the active group and 2.61 to 82.04 in the placebo group. A higher score indicates greater pain relief.|24 Hours||||units on a scale||Standard Error|Least Squares Mean
2584417|NCT02356588|Secondary|TOTPAR12|Total pain relief over the 12 hours. The observed total pain relief scores ranged from 4.08 to 47.50 in the active group and 1.77 to 33.71 in the placebo group. A higher score indicates greater pain relief.|12 hours||||units on a scale||Standard Error|Least Squares Mean
2584418|NCT02356588|Secondary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24).|The primary outcome measure is the summed pain intensity difference to baseline over the 24-hour study period (SPID-24). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 24 hour study period. The SPID-24 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The observed SPID-24 scores ranged from -70.00 to 148.70 in the active group to -58.09 to 160.24 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.|24 hours||||units on a scale||Standard Error|Least Squares Mean
2584419|NCT02356588|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).|"The primary outcome measure is the summed pain intensity difference to baseline over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point.~The observed SPID-12 scores ranged from -42.15 to 71.87 in the active group and -34.96 to 64.37 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity."|12 hours||||units on a scale||Standard Error|Least Squares Mean
2584420|NCT02356575|Secondary|Treatment Expectancy Scale: Expectancy for Acupuncture Treatment|A 4-item instrument that measures treatment expectancy. The total score was calculated by summing all 4 items. Score ranges from 4 to 20 with higher score indicates greater treatment expectancy.|Baseline||||units on a scale||Standard Deviation|Mean
2584421|NCT02356575|Secondary|Treatment Expectancy Scale: Expectancy for CBT-I Treatment|A 4-item instrument that measures treatment expectancy. The total score was calculated by summing all 4 items. Score ranges from 4 to 20 with higher score indicates greater treatment expectancy.|Baseline||||units on a scale||Standard Deviation|Mean
2584422|NCT02356575|Secondary|Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 20|"A greater positive value represents improvement in symptoms.~The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline."|20 weeks from baseline||||units on a scale||95% Confidence Interval|Mean
2584423|NCT02356575|Secondary|Global Mental Health Scale (PROMIS® Global 10) Change From Baseline at Week 8|"A greater positive value represents improvement in symptoms.~The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline."|8 weeks from baseline||||units on a scale||95% Confidence Interval|Mean
2584424|NCT02356575|Secondary|Global Mental Health Scale (PROMIS® Global 10) at Baseline|The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.|Baseline||||units on a scale||Standard Deviation|Mean
2584481|NCT02355977|Secondary|Bacterial Load|Real-time quantitative PCR (qRT-PCR) was used as a powerful tool with high sensitivity and specificity to quantitatively assess target periodontal bacteria.|7 days|The analyzed units of the gene load of bacteria are log10.|||log10 (copies/ml)||Standard Deviation|Mean
2584425|NCT02356575|Secondary|Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 20|"A greater positive value represents improvement in symptoms.~The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline."|20 weeks from baseline||||units on a scale||95% Confidence Interval|Mean
2584426|NCT02356575|Secondary|Global Physical Health Scale (PROMIS® Global 10) Change From Baseline at Week 8|"A greater positive value represents improvement in symptoms.~The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline."|8 weeks from baseline||||units on a scale||95% Confidence Interval|Mean
2584427|NCT02356575|Secondary|Global Physical Health Scale (PROMIS® Global 10) at Baseline|The 10-item Patient-Reported Outcomes Measurement Information System Global Health Scale (PROMIS® Global 10) was used to assess key quality of life domains including pain, fatigue, mental health, physical health, social health, and overall health. There are two 4-item domains: global physical health (domain score ranges from 4 to 20) and global mental health (domain score ranges from 4 to 20). Higher score indicates better quality of life. A greater positive value represents improvement in symptoms from baseline.|Baseline||||units on a scale||Standard Deviation|Mean
2584428|NCT02356575|Secondary|Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 20|"A greater negative value represents improvement in symptoms.~This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety."|20 weeks||||units on a scale||95% Confidence Interval|Mean
2584429|NCT02356575|Secondary|Hospital Anxiety and Depression Scale (HADS) - Change in Depression From Baseline at Week 8|"A greater negative value represents improvement in symptoms.~This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety."|8 weeks from baseline||||units on a scale||95% Confidence Interval|Mean
2584430|NCT02356575|Secondary|Hospital Anxiety and Depression Scale (HADS) - Depression at Baseline|This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.|Baseline||||units on a scale||Standard Deviation|Mean
2584431|NCT02356575|Secondary|Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 20|"A greater negative value represents improvement in symptoms.~This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety."|20 weeks from baseline||||units on a scale||95% Confidence Interval|Mean
2584432|NCT02356575|Secondary|Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety From Baseline at Week 8|"A greater negative value represents improvement in symptoms.~This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety."|8 weeks from baseline||||units on a scale||95% Confidence Interval|Mean
2584433|NCT02356575|Secondary|Hospital Anxiety and Depression Scale (HADS) - Anxiety at Baseline|This is a 14 item, self-rated instrument for anxiety (7 items) and depression (7 items) symptoms in the past week and has been extensively used in people with cancer. Established cutoffs for the depression and anxiety scales are independent and are: 0-7 not significant; 8-10 subclinicao; and 11-21 clinically significant depression/anxiety.|Baseline||||units on a scale||Standard Deviation|Mean
2584434|NCT02356575|Secondary|Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 20|"A greater negative value represents improvement in symptoms.~A 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. We reported the total fatigue score by summing all the items. Multidimensional Fatigue Inventory-Short Form / MFSI-SF total score ranges from 0 to 120 with higher score indicates more fatigue."|20 weeks from baseline||||score on MFSI-F||95% Confidence Interval|Mean
2584435|NCT02356575|Secondary|Multidimensional Fatigue Inventory-Short Form (MFSI-SF) Change From Baseline at Week 8|"A greater negative value represents improvement in symptoms.~A 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. We reported the total fatigue score by summing all the items. Multidimensional Fatigue Inventory-Short Form / MFSI-SF total score ranges from 0 to 120 with higher score indicates more fatigue."|8 weeks from baseline||||units on a scale||95% Confidence Interval|Mean
2584436|NCT02356575|Secondary|Multidimensional Fatigue Inventory-Short Form (MFSI-SF) at Baseline|"The Multidimensional Fatigue Inventory-Short Form (MFSI-SF) is a 30 item self-report measure. Higher scores indicate more fatigue.~A 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. We reported the total fatigue score by summing all the items. Multidimensional Fatigue Inventory-Short Form / MFSI-SF total score ranges from 0 to 120 with higher score indicates more fatigue."|Baseline||||units on a scale||Standard Deviation|Mean
2584482|NCT02355977|Secondary|Bleeding on Probing|BOP is evaluated for the treated tooth using the sulcus bleeding index (SBI) by Muhlemann with a range of 0 (no bleeding) to 5 (profuse bleeding)|7 days||||units on a scale||Standard Deviation|Mean
2584437|NCT02356575|Secondary|The Brief Pain Inventory (BPI) Change From Baseline at Week 20|"A greater negative value represents improvement in symptoms.~Brief Pain Inventory (BPI) is an 11-item pain assessment tool for use with cancer patients. The BPI has two subscales, pain severity and pain interference. Here we reported BPI severity which is an average of 4 questions. The BPI severity score ranges from 0-10 with higher number indicating worse pain symptom."|20 weeks from baseline||||units on a scale||95% Confidence Interval|Mean
2584438|NCT02356575|Secondary|Brief Pain Inventory (BPI) Change From Baseline at Week 8|"A greater negative value represents improvement in symptoms.~Brief Pain Inventory (BPI) is an 11-item pain assessment tool for use with cancer patients. The BPI has two subscales, pain severity and pain interference. Here we reported BPI severity which is an average of 4 questions. The BPI severity score ranges from 0-10 with higher number indicating worse pain symptom."|8 weeks from baseline||||units on a scale||95% Confidence Interval|Mean
2584439|NCT02356575|Secondary|Brief Pain Inventory (BPI) at Baseline|Brief Pain Inventory (BPI) is an 11-item pain assessment tool for use with cancer patients. The BPI has two subscales, pain severity and pain interference. Here we reported BPI severity which is an average of 4 questions. The BPI severity score ranges from 0-10 with higher number indicating worse pain symptom.|Baseline||||units on a scale||Standard Deviation|Mean
2584440|NCT02356575|Secondary|The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 20|"A greater positive value represents improvement in symptoms. Please note this reflects a change from Baseline to Week 20.~Sleep efficiency was calculated as a ratio of total sleep time divided by time in bed multiplied by 100 to yield a percentage. higher number indicated better sleep efficiency."|20 weeks from baseline||||percentage change||95% Confidence Interval|Mean
2584441|NCT02356575|Secondary|The Consensus Sleep Diary (CSD) Sleep Efficiency Change From Baseline at Week 8|"A greater positive value represents improvement in symptoms. Please note this reflects a change from Baseline to Week 8.~Sleep efficiency was calculated as a ratio of total sleep time divided by time in bed multiplied by 100 to yield a percentage. higher number indicated better sleep efficiency."|8 weeks from baseline||||percentage change||95% Confidence Interval|Mean
2584442|NCT02356575|Secondary|The Consensus Sleep Diary (CSD) Sleep Efficiency at Baseline|Sleep efficiency was calculated as a ratio of total sleep time divided by time in bed multiplied by 100 to yield a percentage. A higher number indicates better sleep efficiency.|Baseline||||percentage of efficiency||Standard Deviation|Mean
2584443|NCT02356575|Secondary|The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 20|"A greater positive value represents improvement in symptoms. Please note this reflects the change from Baseline to Week 20.~The Consensus Sleep Diary (CSD) will be used to calculate total sleep time. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment."|20 weeks from baseline||||minutes||95% Confidence Interval|Mean
2584444|NCT02356575|Secondary|The Consensus Sleep Diary (CSD) Total Sleep Time Change From Baseline at Week 8|"A greater positive value represents improvement in symptoms. Please note this reflects the change from Baseline to Week 8.~The Consensus Sleep Diary (CSD) will be used to calculate total sleep time. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment."|8 weeks from baseline||||minutes||95% Confidence Interval|Mean
2584445|NCT02356575|Secondary|The Consensus Sleep Diary (CSD) Baseline Total Sleep Time|The Consensus Sleep Diary (CSD) will be used to calculate total sleep time. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.|Baseline||||minutes||Standard Deviation|Mean
2584446|NCT02356575|Secondary|The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at 20 Weeks|"A greater negative value represents improvement in symptoms. Please note this is the change from Baseline to Week 20.~The Consensus Sleep Diary (CSD) will be used to calculate sleep-onset latency. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment."|20 weeks from baseline||||minutes||95% Confidence Interval|Mean
2584447|NCT02356575|Secondary|The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset Change From Baseline at Week 8|"A greater negative value represents improvement in symptoms. Please note this is the change from Baseline to Week 8.~The Consensus Sleep Diary (CSD) will be used to calculate sleep-onset latency. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment."|8 weeks from baseline||||minutes||95% Confidence Interval|Mean
2584448|NCT02356575|Secondary|The Consensus Sleep Diary (CSD) Minutes Wake After Sleep Onset at Baseline|The Consensus Sleep Diary (CSD) will be used to calculate wake after sleep onset. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.|Baseline||||minutes||Standard Error|Mean
2584449|NCT02356575|Secondary|The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 20|"A greater negative value represents improvement in symptoms. Please note this is the change in sleep onset from Baseline at Week 20.~The Consensus Sleep Diary (CSD) will be used to calculate sleep onset. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment."|20 weeks from baseline||||minutes||95% Confidence Interval|Mean
2584450|NCT02356575|Secondary|The Consensus Sleep Diary (CSD) Sleep Onset Change From Baseline at Week 8|"A greater negative value represents improvement in symptoms. Please note this is the change in sleep onset from Baseline at Week 8.~The Consensus Sleep Diary (CSD) will be used to calculate sleep onset. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment."|8 weeks from baseline||||minutes||95% Confidence Interval|Mean
2584451|NCT02356575|Secondary|The Consensus Sleep Diary (CSD) Baseline Sleep Onset|The Consensus Sleep Diary (CSD) will be used to calculate sleep onset at baseline. Sleep diaries are considered a reliable and valid patient report of nightly insomnia symptoms. Participants will complete the sleep diary daily throughout treatment.|Baseline||||minutes||Standard Deviation|Mean
2584483|NCT02355977|Primary|Pocket Depth|PD is measured using a standard CPI（community periodontal index） probe (Shanghai Medical Instruments, Shanghai, China) and assessed to the nearest millimeter.|7 days||||mm||Standard Deviation|Mean
2584452|NCT02356575|Secondary|Pittsburgh Sleep Quality Index (PSQI) From Baseline at 20 Weeks|"A greater negative value represents improvement in symptoms. Please note that this is the change in score from baseline to 20 weeks.~The Pittsburgh Sleep Quality Index was specifically designed for use in clinical populations to assess seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score. It consists of 19 self-rated questions that are scored on a 0 to 3 scale over a period of one month, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5 or greater indicates a poor sleeper. Overall score ranges from 0 to 21."|20 weeks from baseline||||units on a scale||95% Confidence Interval|Mean
2584453|NCT02356575|Secondary|Pittsburgh Sleep Quality Index (PSQI) Change From Baseline at 8 Weeks|"A greater negative value represents improvement in symptoms. Please note this is the change in score from baseline at 8 weeks.~The Pittsburgh Sleep Quality Index was specifically designed for use in clinical populations to assess seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score. It consists of 19 self-rated questions that are scored on a 0 to 3 scale over a period of one month, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5 or greater indicates a poor sleeper. Overall score ranges from 0 to 21."|8 weeks from baseline||||units on a scale||95% Confidence Interval|Mean
2584454|NCT02356575|Secondary|Pittsburgh Sleep Quality Index (PSQI) at Baseline|"The Pittsburgh Sleep Quality Index was specifically designed for use in clinical populations to assess seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) and a global score. It consists of 19 self-rated questions that are scored on a 0 to 3 scale over a period of one month, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5 or greater indicates a poor sleeper. Overall score ranges from 0 to 21."|Baseline||||units on a scale||Standard Deviation|Mean
2584455|NCT02356575|Primary|Insomnia Severity Index (ISI) Change From Baseline at 20 Weeks|"A greater negative value represents improvement in symptoms.~The Insomnia Severity Index (ISI) is one of the few well-validated patient-reported outcome measure designed to specifically assess the impact on daytime functioning and the amount of associated distress. The ISI includes 7 items that are scored on a five-point scale ranging from 0 to 4 with higher scores representing more severe insomnia symptoms. The optimal cutoff scores are 0-7 (no clinically significant sleep difficulties), 8-14 (sleep difficulties warrant further investigation), and 15+ (presence of clinically significant insomnia). Maximum score on this scale is 28."|20 weeks from baseline||||units on a scale||95% Confidence Interval|Mean
2584456|NCT02356575|Primary|Insomnia Severity Index (ISI) Change From Baseline at 8 Weeks|"A greater negative value represents improvement in symptoms.~The Insomnia Severity Index (ISI) is one of the few well-validated patient-reported outcome measure designed to specifically assess the impact on daytime functioning and the amount of associated distress. The ISI includes 7 items that are scored on a five-point scale ranging from 0 to 4 with higher scores representing more severe insomnia symptoms. The optimal cutoff scores are 0-7 (no clinically significant sleep difficulties), 8-14 (sleep difficulties warrant further investigation), and 15+ (presence of clinically significant insomnia). Maximum score on this scale is 28."|8 weeks from baseline||||units on a scale||95% Confidence Interval|Mean
2584457|NCT02356575|Primary|Insomnia Severity Index (ISI) at Baseline|The Insomnia Severity Index (ISI) is one of the few well-validated patient-reported outcome measure designed to specifically assess the impact on daytime functioning and the amount of associated distress. The ISI includes 7 items that are scored on a five-point scale ranging from 0 to 4 with higher scores representing more severe insomnia symptoms. The optimal cutoff scores are 0-7 (no clinically significant sleep difficulties), 8-14 (sleep difficulties warrant further investigation), and 15+ (presence of clinically significant insomnia). Maximum score on this scale is 28.|At Baseline||||score on a scale||Standard Deviation|Mean
2584458|NCT02356562|Secondary|Percentage of Participants With Post-Treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment.|Within 12 weeks after the last actual dose of active study drug|All participants who received at least 1 dose of study drug (ITT population) with HCV RNA < LLOQ at the end of treatment and completed treatment. Per protocol, data from Parts 1 and 2 were not combined for analysis.|||percentage of participants||95% Confidence Interval|Number
2584459|NCT02356562|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment.|Up to week 24|All participants who received at least 1 dose of study drug (ITT population). Per protocol, data from Parts 1 and 2 were not combined for analysis.|||percentage of participants||95% Confidence Interval|Number
2584460|NCT02356562|Secondary|Percentage of Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment|SVR12 was defined as plasma HCV RNA level <LLOQ 12 weeks after the last dose of study drug|12 weeks after the last dose of active drug|All Part 2 participants who received at least 1 dose of study drug (ITT population). Per protocol, data from Parts 1 and 2 were not combined for analysis.|||percentage of participants||95% Confidence Interval|Number
2584461|NCT02356562|Primary|Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last dose of active drug|All Part 1 participants who received at least 1 dose of study drug (ITT population). Per protocol, data from Parts 1 and 2 were not combined for analysis.|||percentage of participants||95% Confidence Interval|Number
2584462|NCT02356471|Secondary|Change in Fatigue Assessment- Fatigue Visual Analog Scale (FVAS).|The fatigue VAS is a unidimensional measure of fatigue providing a range of scores from 0-100. A higher score indicates greater fatigue. Change in median (IQR) fatigue score from baseline to 90 days is reported.|baseline and 90 days|Only 6 subjects reported fatigue VAS at baseline and 90 days.|||units on a scale||Inter-Quartile Range|Median
2605723|NCT02107014|Primary|Change in TNF-α From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2584463|NCT02356471|Secondary|Change in Pain Assessment -Pain Visual Analog Scale, (PVAS)|The pain VAS is a unidimensional measure of pain intensity providing a range of scores from 0-100. A higher score indicates greater pain intensity. Change in median (IQR) pain score from baseline to 90 days is reported.|baseline and 90 days|Only 6 subjects had pain VAS measured at baseline and 90 days.|||units on a scale||Inter-Quartile Range|Median
2584464|NCT02356471|Secondary|Change in Health-related Quality of Life (FACT-G) Questionnaire|FACT-G is a 27-item compilation of general questions divided into 4 primary quality of life (QOL) domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The subscales are summed to produce a total score. The total score range is 0-108 and a higher score indicates better quality of life. Outcomes is to compare FACT-G at baseline and 90 days. Change in FACT-G is reported in median (IQR).|baseline and 90 days|Only 6 subjects reported FACT-G at baseline and 90 days.|||units on a scale||Inter-Quartile Range|Median
2584465|NCT02356471|Secondary|Change in CHAMPS Between the Pre- and Post-operative Period|This outcome measure is to compare self-reported activity data (CHAMPS) during the pre- and post-operative period. Median (IQR) change in CHAMPS is reported. CHAMPS measures activity of the participant and how long they could do the activity. The score range is 0-108. Higher scores denotes better outcomes.|baseline and 90 days|5 subjects have CHAMPs data at baseline and 90 days.|||score on a scale||Inter-Quartile Range|Median
2584466|NCT02356471|Secondary|Change in the Mobility Assessment Tool-Short Form (MAT-sf).|This outcome measure is to compare pre- and post-operative self-reported mobility using the Mobility Assessment Tool-Short Form (MAT-sf). Median (IQR) change in MAT-sf is reported. The score range is 30-80 and higher scores denotes better outcomes.|baseline and 90 days|Only 7 subjects had MAT-sf measured at baseline and 90 days.|||units on a scale||Inter-Quartile Range|Median
2584467|NCT02356471|Secondary|Change in Pepper Assessment Tool for Disability (PAT-D)|This outcome measure is to compare pre- and post-operative self-reported mobility using the Pepper Assessment Tool for Disability (PAT-D). Median (IQR) change in PAT-D is reported.|baseline and 90 days|Data were not collected and therefore analysis cannot performed.||||||
2584468|NCT02356471|Secondary|Change in Duration of 400-meter Walk|This outcome measure is to compare pre- and post-operative mobility testing using the 400-meter walk. Median (IQR) change in 400 m walk from baseline to 90 days is reported. The duration it takes the participant to walk 400 meters will be recorded in seconds.|baseline and 90 days|Only 10 subjects had 400m walk measured at baseline and 90 days|||seconds||Inter-Quartile Range|Median
2584469|NCT02356471|Secondary|Change in Short Physical Performance Battery (SPPB)|This outcome measure is to compare pre- and post-operative mobility using the Short Physical Performance Battery (SPPB). Median (IQR) change in SPPB from baseline to 90 days is reported.The scale range is 0-16. Higher scores denotes better outcomes.|baseline and 90 days|Only 9 subjects had SPPB measured at baseline and 90 days.|||units on a scale||Inter-Quartile Range|Median
2584470|NCT02356471|Secondary|Change in Daily Steps for Participants Before and After Major Oncologic Surgery|This outcome measure will be the change in daily steps for participants before and after major oncologic surgery. Change in median (IQR) steps reported.|baseline and 90 days|16 subjects had sufficient data for partial analysis.|||steps||Inter-Quartile Range|Median
2584471|NCT02356471|Primary|Number of Patients Who Self-report Wearing the Consumer-based Activity Monitor at Least 16 Days of the 21 Day Period|Feasibility will be defined as the number of patients who self-report wearing the CAM device at least 16 days of the 21 day period.|21 days|34 patients enrolled in study. 28 patients had data collected. Due to challenges associated with data collection, partial data was collected for 18 patients.|||Participants|||Count of Participants
2584472|NCT02356211|Primary|Number of Participants Who Experienced Falls|Number of participants who experienced falls in 12 months, based on self-recall and telephone interview.|12 months||||Participants|||Count of Participants
2584473|NCT02356198|Secondary|Use of Intravenous Patient-controlled Analgesia|The total number of patients that used patient-controlled analgesia within 48 hours after surgery.|First 48 hours post-operative||||Participants|||Count of Participants
2584474|NCT02356198|Secondary|Number of Participants With Post-operative Ileus|Post-operative ileus was defined as the inability to tolerate oral diet and/or the absence of flatus over 24 hours after surgery.|24 hours post-operatively||||Participants|||Count of Participants
2584475|NCT02356198|Secondary|Total Length of Hospital Stay|Length of stay was defined as the total number of nights spent in the hospital after surgery.|post-operative to discharge||||nights||95% Confidence Interval|Median
2584476|NCT02356198|Primary|Total Morphine Milligram Equivalents Use (MME)|The total cumulative use of opioids administered within 48 hours after surgery. MME is a standard value based on morphine and its potency assigned to all opioids to represent relative potencies.|First 48 hours post operative||||total morphine milligram equivalents||95% Confidence Interval|Median
2584477|NCT02356198|Primary|Mean Pain Score|Postoperative mean pain score for 48 hours after surgery. Pain was assessed on a 0 to 10 point visual analog scale (VAS), with 0 indicating no pain and 10 indicating severe pain. The mean pain score was summarized as the area under the curve (AUC) of the observed pain score, normalized for the total time of observation.|First 48 hours post operative||||score on a scale||95% Confidence Interval|Mean
2584478|NCT02356107|Primary|Change From Baseline in Hamilton Depression Rating Scale|The purpose of this study is to determine if 8 weeks of dietary augmentation with oral 5 g creatine daily and 100 mg 5-HTP twice daily reduces hypoxia-related depressive symptoms measured by the 17-item Hamilton Depression Rating Scale (HAM-D) in women with SSRI or SNRI resistant depression. HAM-D (outcome measure) was used to assess the level of depression at baseline and after 8 weeks of using the study drug. The Hamilton Depression Rating Scale ranges from 0 to 50. A score of 0-7 is considered to be normal. A score of 8-13 indicates mild depression. A score of 14-18 indicates moderate depression. Scores higher than 19 indicate severe depression.|8 weeks||||units on a scale||Standard Deviation|Mean
2584479|NCT02356003|Secondary|Glutamate Concentration|Glutamate concentration in the supplementary motor area|Four weeks|We stopped recruitment at 10 as the study ran out of money.|||mM||Standard Deviation|Mean
2584480|NCT02356003|Primary|Yale Global Tic Severity Scale|Measure of tic severity using the Yale Global Tic Severity Scale (YGTSS). This is the standard measure for studies of Tourette's syndrome. The Global Severity Score has a range of 0- 100. A higher score on all scales suggests greater severity of tics.|Four weeks|We stopped recruitment at 10 as the study ran out of money.|||units on a scale||Standard Deviation|Mean
2584484|NCT02355886|Secondary|Patient Self-assessed Pain on Numerical Pain Scale|The two study groups compared on Patient self-assessed pain on numerical pain likert scale. Numeric Pain Scale was utilized with values of 0-10 with increasing severity.|Up to 48 hours post-radical cystectomy||||Sore on a scale||Standard Deviation|Mean
2584485|NCT02355886|Secondary|Length of Stay Following Radical Cystectomy|The two study groups will be compared by Length of stay following radical cystectomy|duration of hospital stay. Days to weeks||||days||Standard Deviation|Mean
2584486|NCT02355886|Primary|Patient Total Equivalent Analgesic Requirement (Morphine Equivalents)|Geometric Mean and Standard Deviation of patient total equivalent analgesic|48 hours post-radical cystectomy||||Total oral morphine equivalents in mg||Standard Deviation|Geometric Mean
2584487|NCT02355743|Secondary|Need for Central Line Replacement|This will be defined as a line removal and replacement due to infection, malfunction or other issues|24 weeks||||line replacements||Inter-Quartile Range|Median
2584488|NCT02355743|Secondary|Development of Line-associated Infection|This will be defined as a line associated infection not related to other co-infection (i.e. such as pneumonia, UTI)|24 weeks||||infections||Inter-Quartile Range|Median
2584489|NCT02355743|Primary|Development of CVAD Line Thrombosis|This will be defined as a thrombosis that is discovered due to clinical findings concerning for a possible thrombosis as identified by the treating physician including, but not limited to, swelling, color change, or pain in the extremity, CVAD not providing blood return and/or being able to be flushed.|24 weeks||||thromboses||Full Range|Mean
2584490|NCT02355691|Secondary|Number of Participants With Infection|"The investigators will continue to monitor the patients for development of an acute postoperative infection. A deep infection refers to an infection below the superficial soft tissue and likely involving the prosthesis. This will be evaluated by the musculoskeletal infection society consensus on total joint infection.~Criteria include:(Either one major criteria or four minor criteria) Major criteria Sinus track communicating with the prosthesis Two separate cultures from the joint positive for the same organism~Minor criteria Elevated erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) Elevated synovial leukocyte count Elevated synovial neutrophil percentage Purulent drainage from the joint One positive fluid culture from the joint Histological analysis of tissue showing more than 5 neutrophils per high power field in 5 fields"|(Single point evaluation)-6 weeks post surgery visit|Measured all that enrolled and completed the treatment|||Participants|||Count of Participants
2584491|NCT02355691|Primary|Mean Wound Healing Scores by the ASEPSIS Criteria|A method of evaluating wounds for infection risk that incorporates multiple wound healing factors such as erythema, drainage, and dehiscence is the ASEPSIS (Additional treatment, presence of Serous discharge, Erythema, Purulent exudate, Separation of the deep tissue, Isolation of bacteria, and duration of inpatient Stay) wound scoring system. Originally developed and validated for cardiac surgery sternal wounds, ASEPSIS evaluates the wound for the severity of multiple factors linked with surgical site infection. This includes dehiscence, exudate/discharge, and erythema. The higher the score, the more likely a surgical site infection will be present. This score will give us a more diverse picture of postoperative wound healing and the influence of Negative Pressure Wound Therapy. Scores can range from 0 to 65, with most scores expected at the lower scale.|(Single point evaluation)-2 weeks post surgery visit|Measured outcomes for all patients that completed the treatment|||units on a scale||Full Range|Mean
2584492|NCT02355665|Secondary|Change From Baseline in Body Weight at Week 26 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit|Change from baseline in body weight|Baseline to Week 26|Analysis was based on randomized participants verified continuously abstinent from smoking since the Week 2 visit.|||pounds||Standard Deviation|Mean
2584493|NCT02355665|Secondary|Change From Baseline in Body Weight at Week 12 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit|Change from baseline in body weight|Baseline to Week 12|Analysis was based on randomized participants verified continuously abstinent from smoking since the Week 2 visit.|||pounds||Standard Deviation|Mean
2584494|NCT02355665|Secondary|Change From Baseline in Body Weight at Week 6 in Participants Verified Continuously Abstinent From Smoking From the Week 2 Visit|Change from baseline in body weight|Baseline to Week 6|Analysis was based on randomized participants verified continuously abstinent from smoking since the Week 2 visit.|||pounds||Standard Deviation|Mean
2584495|NCT02355665|Secondary|Change From Baseline in Body Weight at Week 26|Change from baseline in body weight|Baseline to Week 26|Analysis was based on the Full Analysis Set which included all randomized participants.|||pounds||Standard Deviation|Mean
2584496|NCT02355665|Secondary|Change From Baseline in Body Weight at Week 12|Change from baseline in body weight|Baseline to Week 12|Analysis was based on the Full Analysis Set which included all randomized participants.|||pounds||Standard Deviation|Mean
2584497|NCT02355665|Secondary|Change From Baseline in Body Weight at Week 6|Change from baseline in body weight|Baseline to Week 6|Analysis was based on the Full Analysis Set which included all randomized participants.|||pounds||Standard Deviation|Mean
2584498|NCT02355665|Secondary|Percentage of Participants With New or Worsened Conditions in Visual Mouth Inspection Overall at Week 6 or When Withdrawn From Study|Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.|Week 6 or when withdrawn from study|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||Percentage of Participants|||Number
2584499|NCT02355665|Secondary|Percentage of Participants With New or Worsened Conditions in Uvula/Oropharynx at Week 6 or When Withdrawn From Study|Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.|Week 6 or when withdrawn from study|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||Percentage of Participants|||Number
2584516|NCT02355665|Secondary|Pulse at Week 26|Pulse (beats per minute)|Week 26|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||beats per minute||Standard Deviation|Mean
2584500|NCT02355665|Secondary|Percentage of Participants With New or Worsened Conditions in Hard/Soft Palate at Week 6 or When Withdrawn From Study|Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.|Week 6 or when withdrawn from study|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||Percentage of Participants|||Number
2584501|NCT02355665|Secondary|Percentage of Participants With New or Worsened Conditions in Tongue at Week 6 or When Withdrawn From Study|Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.|Week 6 or when withdrawn from study|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||Percentage of Participants|||Number
2584502|NCT02355665|Secondary|Percentage of Participants With New or Worsened Conditions in Gingiva at Week 6 or When Withdrawn From Study|Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.|Week 6 or when withdrawn from study|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||Percentage of Participants|||Number
2584503|NCT02355665|Secondary|Percentage of Participants With New or Worsened Conditions in Sublingual Mucosa at Week 6 or When Withdrawn From Study|Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.|Week 6 or when withdrawn from study|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||Percentage of Participants|||Number
2584504|NCT02355665|Secondary|Percentage of Participants With New or Worsened Conditions in Mucobuccal Fold at Week 6 or When Withdrawn From Study|Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.|Week 6 or when withdrawn from study|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||Percentage of Participants|||Number
2584505|NCT02355665|Secondary|Percentage of Participants With New or Worsened Conditions in Buccal Mucosa at Week 6 or When Withdrawn From Study|Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.|Week 6 or when withdrawn from study|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||Percentage of Participants|||Number
2584506|NCT02355665|Secondary|Percentage of Participants With New or Worsened Conditions in Lips/Labial Mucosa at Week 6 or When Withdrawn From Study|Visual mouth inspection (VMI) performed at the site or local dental office by a licensed dentist or an examiner such as a dental hygienist with documented training in oral clinical exams. Extraoral and intraoral tissues were examined. Abnormalities were recorded; it was determined if abnormalities were new or had worsened since baseline VMI findings.|Week 6 or when withdrawn from study|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||Percentage of Participants|||Number
2584507|NCT02355665|Secondary|Change From Baseline in Pulse at Week 26|Change from baseline in pulse (beats per minute)|Baseline to Week 26|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||beats per minute||Standard Deviation|Mean
2584508|NCT02355665|Secondary|Change From Baseline in Pulse at Week 20|Change from baseline in pulse (beats per minute)|Baseline to Week 20|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||beats per minute||Standard Deviation|Mean
2584509|NCT02355665|Secondary|Change From Baseline in Pulse at Week 16|Change from baseline in pulse (beats per minute)|Baseline to Week 16|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||beats per minute||Standard Deviation|Mean
2584510|NCT02355665|Secondary|Change From Baseline in Pulse at Week 12|Change from baseline in pulse (beats per minute)|Baseline to Week 12|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||beats per minute||Standard Deviation|Mean
2584511|NCT02355665|Secondary|Change From Baseline in Pulse at Week 8|Change from baseline in pulse (beats per minute)|Baseline to Week 8|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||beats per minute||Standard Deviation|Mean
2584512|NCT02355665|Secondary|Change From Baseline in Pulse at Week 6|Change from baseline in pulse (beats per minute)|Baseline to Week 6|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||beats per minute||Standard Deviation|Mean
2584513|NCT02355665|Secondary|Change From Baseline in Pulse at Week 4|Change from baseline in pulse (beats per minute)|Baseline to Week 4|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||beats per minute||Standard Deviation|Mean
2584514|NCT02355665|Secondary|Change From Baseline in Pulse at Week 2|Change from baseline in pulse (beats per minute)|Baseline to Week 2|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||beats per minute||Standard Deviation|Mean
2584515|NCT02355665|Secondary|Change From Baseline in Pulse at Week 1|Change from baseline in pulse (beats per minute)|Baseline to Week 1|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||beats per minute||Standard Deviation|Mean
2584521|NCT02355665|Secondary|Pulse at Week 6|Pulse (beats per minute)|Week 6|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||beats per minute||Standard Deviation|Mean
2584522|NCT02355665|Secondary|Pulse at Week 4|Pulse (beats per minute)|Week 4|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||beats per minute||Standard Deviation|Mean
2584523|NCT02355665|Secondary|Pulse at Week 2|Pulse (beats per minute)|Week 2|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||beats per minute||Standard Deviation|Mean
2584524|NCT02355665|Secondary|Pulse at Week 1|Pulse (beats per minute)|Week 1|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||beats per minute||Standard Deviation|Mean
2584525|NCT02355665|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 26|Change from baseline in diastolic blood pressure (mm Hg)|Baseline to Week 26|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584526|NCT02355665|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 20|Change from baseline in diastolic blood pressure (mm Hg)|Baseline to Week 20|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584527|NCT02355665|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 16|Change from baseline in diastolic blood pressure (mm Hg)|Baseline to Week 16|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584528|NCT02355665|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 12|Change from baseline in diastolic blood pressure (mm Hg)|Baseline to Week 12|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584529|NCT02355665|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 8|Change from baseline in diastolic blood pressure (mm Hg)|Baseline to Week 8|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584530|NCT02355665|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 6|Change from baseline in diastolic blood pressure (mm Hg)|Baseline to Week 6|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584531|NCT02355665|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 4|Change from baseline in diastolic blood pressure (mm Hg)|Baseline to Week 4|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584532|NCT02355665|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 2|Change from baseline in diastolic blood pressure (mm Hg)|Baseline to Week 2|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584533|NCT02355665|Secondary|Change From Baseline in Diastolic Blood Pressure at Week 1|Change from baseline in diastolic blood pressure (mm Hg)|Baseline to Week 1|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584534|NCT02355665|Secondary|Diastolic Blood Pressure at Week 26|Diastolic blood pressure (mm Hg)|Week 26|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584535|NCT02355665|Secondary|Diastolic Blood Pressure at Week 20|Diastolic blood pressure (mm Hg)|Week 20|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584536|NCT02355665|Secondary|Diastolic Blood Pressure at Week 16|Diastolic blood pressure (mm Hg)|Week 16|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584537|NCT02355665|Secondary|Diastolic Blood Pressure at Week 12|Diastolic blood pressure (mm Hg)|Week 12|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584538|NCT02355665|Secondary|Diastolic Blood Pressure at Week 8|Diastolic blood pressure (mm Hg)|Week 8|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584539|NCT02355665|Secondary|Diastolic Blood Pressure at Week 6|Diastolic blood pressure (mm Hg)|Week 6|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584540|NCT02355665|Secondary|Diastolic Blood Pressure at Week 4|Diastolic blood pressure (mm Hg)|Week 4|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584541|NCT02355665|Secondary|Diastolic Blood Pressure at Week 2|Diastolic blood pressure (mm Hg)|Week 2|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584542|NCT02355665|Secondary|Diastolic Blood Pressure at Week 1|Diastolic blood pressure (mm Hg)|Week 1|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584543|NCT02355665|Secondary|Change From Baseline in Systolic Blood Pressure at Week 26|Change from baseline in systolic blood pressure (mm Hg)|Baseline to Week 26|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584544|NCT02355665|Secondary|Change From Baseline in Systolic Blood Pressure at Week 20|Change from baseline in systolic blood pressure (mm Hg)|Baseline to Week 20|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584545|NCT02355665|Secondary|Change From Baseline in Systolic Blood Pressure at Week 16|Change from baseline in systolic blood pressure (mm Hg)|Baseline to Week 16|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2605724|NCT02107014|Primary|Change in IFN-γ From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2584546|NCT02355665|Secondary|Change From Baseline in Systolic Blood Pressure at Week 12|Change from baseline in systolic blood pressure (mm Hg)|Baseline to Week 12|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584547|NCT02355665|Secondary|Change From Baseline in Systolic Blood Pressure at Week 8|Change from baseline in systolic blood pressure (mm Hg)|Baseline to Week 8|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584548|NCT02355665|Secondary|Change From Baseline in Systolic Blood Pressure at Week 6|Change from baseline in systolic blood pressure (mm Hg)|Baseline to Week 6|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584549|NCT02355665|Secondary|Change From Baseline in Systolic Blood Pressure at Week 4|Change from baseline in systolic blood pressure (mm Hg)|Baseline to Week 4|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584550|NCT02355665|Secondary|Change From Baseline in Systolic Blood Pressure at Week 2|Change from baseline in systolic blood pressure (mm Hg)|Baseline to Week 2|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584551|NCT02355665|Secondary|Change From Baseline in Systolic Blood Pressure at Week 1|Change from baseline in systolic blood pressure (mm Hg)|Baseline to Week 1|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584552|NCT02355665|Secondary|Systolic Blood Pressure at Week 26|Systolic blood pressure (mm Hg)|Week 26|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584553|NCT02355665|Secondary|Systolic Blood Pressure at Week 20|Systolic blood pressure (mm Hg)|Week 20|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584554|NCT02355665|Secondary|Systolic Blood Pressure at Week 16|Systolic blood pressure (mm Hg)|Week 16|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584555|NCT02355665|Secondary|Systolic Blood Pressure at Week 12|Systolic blood pressure (mm Hg)|Week 12|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584556|NCT02355665|Secondary|Systolic Blood Pressure at Week 8|Systolic blood pressure (mm Hg)|Week 8|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584557|NCT02355665|Secondary|Systolic Blood Pressure at Week 6|Systolic blood pressure (mm Hg)|Week 6|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584558|NCT02355665|Secondary|Systolic Blood Pressure at Week 4|Systolic blood pressure (mm Hg)|Week 4|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584559|NCT02355665|Secondary|Systolic Blood Pressure at Week 2|Systolic blood pressure (mm Hg)|Week 2|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584560|NCT02355665|Secondary|Systolic Blood Pressure at Week 1|Systolic blood pressure (mm Hg)|Week 1|Analysis was based on the Safety Analysis Set which included all randomized participants who received study treatment.|||mm Hg||Standard Deviation|Mean
2584561|NCT02355665|Secondary|Percentage Distribution of the Participant Score for Product Convenience at Week 12|Participants were asked to rate the product convenience on a 5-point scale of 1 - 5 (where 1=not at all convenient and 5=extremely convenient).|Week 12|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584562|NCT02355665|Secondary|Percentage Distribution of the Participant Score for Product Convenience at Week 6|Participants were asked to rate the product convenience on a 5-point scale of 1 - 5 (where 1=not at all convenient and 5=extremely convenient).|Week 6|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584563|NCT02355665|Secondary|Percentage Distribution of the Participant Score for Product Convenience at Week 1|Participants were asked to rate the product convenience on a 5-point scale of 1 - 5 (where 1=not at all convenient and 5=extremely convenient).|Week 1|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584564|NCT02355665|Secondary|Percentage Distribution of the Participant Score for Change of Opinion at Week 12 Concerning Product Compared to When First Used Product|Participants were asked to rate their change of opinion concerning product compared to when first used product on a 5-point scale of 1 - 5 (where 1=I like it much less now and 5=I like it much more now).|Week 12|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584565|NCT02355665|Secondary|Percentage Distribution of the Participant Score for Change of Opinion at Week 6 Concerning Product Compared to When First Used Product|Participants were asked to rate their change of opinion concerning product compared to when first used product on a 5-point scale of 1 - 5 (where 1=I like it much less now and 5=I like it much more now).|Week 6|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584566|NCT02355665|Secondary|Percentage Distribution of the Participant Score for Change of Opinion at Week 1 Concerning Product Compared to When First Used Product|Participants were asked to rate their change of opinion concerning product compared to when first used product on a 5-point scale of 1 - 5 (where 1=I like it much less now and 5=I like it much more now).|Week 1|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584567|NCT02355665|Secondary|Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 12|Participants were asked to rate the speed of action of the product on a 9-point scale of 1 - 9 (where 1=extremely slow and 9=extremely fast).|Week 12|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584568|NCT02355665|Secondary|Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 6|Participants were asked to rate the speed of action of the product on a 9-point scale of 1 - 9 (where 1=extremely slow and 9=extremely fast).|Week 6|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584569|NCT02355665|Secondary|Percentage Distribution of the Participant Score for Speed of Action of the Product at Week 1|Participants were asked to rate the speed of action of the product on a 9-point scale of 1 - 9 (where 1=extremely slow and 9=extremely fast).|Week 1|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584570|NCT02355665|Secondary|Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 12|Participants were asked to rate the product in its effectiveness for dealing with desire/urge to smoke on a 5-point scale of 1 - 5 (where 1=not all effective and 5=extremely effective).|Week 12|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584571|NCT02355665|Secondary|Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 6|Participants were asked to rate the product in its effectiveness for dealing with desire/urge to smoke on a 5-point scale of 1 - 5 (where 1=not all effective and 5=extremely effective).|Week 6|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584572|NCT02355665|Secondary|Percentage Distribution of the Participant Score for Product Effectiveness in Dealing With Desire/Urge to Smoke at Week 1|Participants were asked to rate the product in its effectiveness for dealing with desire/urge to smoke on a 5-point scale of 1 - 5 (where 1=not all effective and 5=extremely effective).|Week 1|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584573|NCT02355665|Secondary|Percentage Distribution of the Participant Score for Overall Product Rating at Week 12|Participants were asked to rate the investigational product on a 10-point scale of 1 - 10 (where 1=very poor and 10=excellent).|Week 12|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584574|NCT02355665|Secondary|Percentage Distribution of the Participant Score for Overall Product Rating at Week 6|Participants were asked to rate the investigational product on a 10-point scale of 1 - 10 (where 1=very poor and 10=excellent).|Week 6|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584575|NCT02355665|Secondary|Percentage Distribution of the Participant Score for Overall Product Rating at Week 1|Participants were asked to rate the investigational product on a 10-point scale of 1 - 10 (where 1=very poor and 10=excellent).|Week 1|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584576|NCT02355665|Secondary|Number of Cigarettes Smoked Per Day at Week 26|Number of Cigarettes Smoked Per Day|Week 26|Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.|||Number of cigarettes||Standard Deviation|Mean
2584577|NCT02355665|Secondary|Number of Cigarettes Smoked Per Day at Week 20|Number of Cigarettes Smoked Per Day|Week 20|Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.|||Number of cigarettes||Standard Deviation|Mean
2584578|NCT02355665|Secondary|Number of Cigarettes Smoked Per Day at Week 16|Number of Cigarettes Smoked Per Day|Week 16|Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.|||Number of cigarettes||Standard Deviation|Mean
2584579|NCT02355665|Secondary|Number of Cigarettes Smoked Per Day at Week 12|Number of Cigarettes Smoked Per Day|Week 12|Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.|||Number of cigarettes||Standard Deviation|Mean
2584580|NCT02355665|Secondary|Number of Cigarettes Smoked Per Day at Week 8|Number of Cigarettes Smoked Per Day|Week 8|Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.|||Number of cigarettes||Standard Deviation|Mean
2584581|NCT02355665|Secondary|Number of Cigarettes Smoked Per Day at Week 6|Number of Cigarettes Smoked Per Day|Week 6|Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.|||Number of cigarettes||Standard Deviation|Mean
2584582|NCT02355665|Secondary|Number of Cigarettes Smoked Per Day at Week 4|Number of Cigarettes Smoked Per Day|Week 4|Analysis was based on randomized participants who reported non-abstinence from smoking during the preceding week.|||Number of cigarettes||Standard Deviation|Mean
2584583|NCT02355665|Secondary|Number of Cigarettes Smoked Since Last Visit at Week 2|Number of Cigarettes Smoked Since Last Visit|Week 2|Analysis was based on randomized participants who reported non-abstinence from smoking since last visit.|||Number of cigarettes||Standard Deviation|Mean
2584584|NCT02355665|Secondary|Number of Cigarettes Smoked Since Last Visit at Week 1|Number of Cigarettes Smoked Since Last Visit|Week 1|Analysis was based on randomized participants who reported non-abstinence from smoking since last visit.|||Number of cigarettes||Standard Deviation|Mean
2584585|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 26|Maximum Hourly Number of Self-Reported Spray Doses|Week 26|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584586|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 25|Maximum Hourly Number of Self-Reported Spray Doses|Week 25|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584587|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 24|Maximum Hourly Number of Self-Reported Spray Doses|Week 24|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584588|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 23|Maximum Hourly Number of Self-Reported Spray Doses|Week 23|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584836|NCT02353806|Secondary|Infant Gestational Age at Delivery.|The mean gestational age of infants born to mothers taking Amlodipine besylate 5 mg daily was collected.|Gestational age at the time of birth||||weeks||Standard Deviation|Mean
2584589|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 22|Maximum Hourly Number of Self-Reported Spray Doses|Week 22|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584590|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 21|Maximum Hourly Number of Self-Reported Spray Doses|Week 21|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584591|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 20|Maximum Hourly Number of Self-Reported Spray Doses|Week 20|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584592|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 19|Maximum Hourly Number of Self-Reported Spray Doses|Week 19|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584593|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 18|Maximum Hourly Number of Self-Reported Spray Doses|Week 18|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584594|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 17|Maximum Hourly Number of Self-Reported Spray Doses|Week 17|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584595|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 16|Maximum Hourly Number of Self-Reported Spray Doses|Week 16|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584596|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 15|Maximum Hourly Number of Self-Reported Spray Doses|Week 15|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584597|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 14|Maximum Hourly Number of Self-Reported Spray Doses|Week 14|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584598|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 13|Maximum Hourly Number of Self-Reported Spray Doses|Week 13|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584599|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 12|Maximum Hourly Number of Self-Reported Spray Doses|Week 12|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584600|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 11|Maximum Hourly Number of Self-Reported Spray Doses|Week 11|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584601|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 10|Maximum Hourly Number of Self-Reported Spray Doses|Week 10|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584602|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 9|Maximum Hourly Number of Self-Reported Spray Doses|Week 9|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584603|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 8|Maximum Hourly Number of Self-Reported Spray Doses|Week 8|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584604|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 7|Maximum Hourly Number of Self-Reported Spray Doses|Week 7|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584605|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 6|Maximum Hourly Number of Self-Reported Spray Doses|Week 6|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584606|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 5|Maximum Hourly Number of Self-Reported Spray Doses|Week 5|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584607|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 4|Maximum Hourly Number of Self-Reported Spray Doses|Week 4|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584608|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 3|Maximum Hourly Number of Self-Reported Spray Doses|Week 3|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584609|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 2|Maximum Hourly Number of Self-Reported Spray Doses|Week 2|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584610|NCT02355665|Secondary|Maximum Hourly Number of Self-Reported Spray Doses at Week 1|Maximum Hourly Number of Self-Reported Spray Doses|Week 1|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584611|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 26|Maximum Total Daily Number of Self-Reported Spray Doses|Week 26|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584736|NCT02354859|Secondary|Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)|Incidence is defined as the number and percentage of participants with at least one event over the 56 day follow-up period.|Day 1 to Day 56||||Participants|||Count of Participants
2584612|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 25|Maximum Total Daily Number of Self-Reported Spray Doses|Week 25|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584613|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 24|Maximum Total Daily Number of Self-Reported Spray Doses|Week 24|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584614|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 23|Maximum Total Daily Number of Self-Reported Spray Doses|Week 23|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584615|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 22|Maximum Total Daily Number of Self-Reported Spray Doses|Week 22|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584616|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 21|Maximum Total Daily Number of Self-Reported Spray Doses|Week 21|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584617|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 20|Maximum Total Daily Number of Self-Reported Spray Doses|Week 20|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584618|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 19|Maximum Total Daily Number of Self-Reported Spray Doses|Week 19|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584619|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 18|Maximum Total Daily Number of Self-Reported Spray Doses|Week 18|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584620|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 17|Maximum Total Daily Number of Self-Reported Spray Doses|Week 17|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584621|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 16|Maximum Total Daily Number of Self-Reported Spray Doses|Week 16|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584622|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 15|Maximum Total Daily Number of Self-Reported Spray Doses|Week 15|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584623|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 14|Maximum Total Daily Number of Self-Reported Spray Doses|Week 14|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584624|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 13|Maximum Total Daily Number of Self-Reported Spray Doses|Week 13|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584625|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 12|Maximum Total Daily Number of Self-Reported Spray Doses|Week 12|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584626|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 11|Maximum Total Daily Number of Self-Reported Spray Doses|Week 11|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584627|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 10|Maximum Total Daily Number of Self-Reported Spray Doses|Week 10|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584628|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 9|Maximum Total Daily Number of Self-Reported Spray Doses|Week 9|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584629|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 8|Maximum Total Daily Number of Self-Reported Spray Doses|Week 8|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584630|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 7|Maximum Total Daily Number of Self-Reported Spray Doses|Week 7|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584631|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 6|Maximum Total Daily Number of Self-Reported Spray Doses|Week 6|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584632|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 5|Maximum Total Daily Number of Self-Reported Spray Doses|Week 5|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584633|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 4|Maximum Total Daily Number of Self-Reported Spray Doses|Week 4|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584634|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 3|Maximum Total Daily Number of Self-Reported Spray Doses|Week 3|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584635|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 2|Maximum Total Daily Number of Self-Reported Spray Doses|Week 2|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584636|NCT02355665|Secondary|Maximum Total Daily Number of Self-Reported Spray Doses at Week 1|Maximum Total Daily Number of Self-Reported Spray Doses|Week 1|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584637|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 26|Total Daily Number of Self-Reported Spray Doses|Week 26|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584638|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 25|Total Daily Number of Self-Reported Spray Doses|Week 25|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584639|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 24|Total Daily Number of Self-Reported Spray Doses|Week 24|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584640|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 23|Total Daily Number of Self-Reported Spray Doses|Week 23|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584641|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 22|Total Daily Number of Self-Reported Spray Doses|Week 22|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584642|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 21|Total Daily Number of Self-Reported Spray Doses|Week 21|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584643|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 20|Total Daily Number of Self-Reported Spray Doses|Week 20|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584644|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 19|Total Daily Number of Self-Reported Spray Doses|Week 19|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584645|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 18|Total Daily Number of Self-Reported Spray Doses|Week 18|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584646|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 17|Total Daily Number of Self-Reported Spray Doses|Week 17|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584647|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 16|Total Daily Number of Self-Reported Spray Doses|Week 16|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584648|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 15|Total Daily Number of Self-Reported Spray Doses|Week 15|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584649|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 14|Total Daily Number of Self-Reported Spray Doses|Week 14|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584650|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 13|Total Daily Number of Self-Reported Spray Doses|Week 13|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584651|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 12|Total Daily Number of Self-Reported Spray Doses|Week 12|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584652|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 11|Total Daily Number of Self-Reported Spray Doses|Week 11|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584653|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 10|Total Daily Number of Self-Reported Spray Doses|Week 10|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584654|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 9|Total Daily Number of Self-Reported Spray Doses|Week 9|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584655|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 8|Total Daily Number of Self-Reported Spray Doses|Week 8|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584656|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 7|Total Daily Number of Self-Reported Spray Doses|Week 7|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584657|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 6|Total Daily Number of Self-Reported Spray Doses|Week 6|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584658|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 5|Total Daily Number of Self-Reported Spray Doses|Week 5|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584659|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 4|Total Daily Number of Self-Reported Spray Doses|Week 4|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584660|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 3|Total Daily Number of Self-Reported Spray Doses|Week 3|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584661|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 2|Total Daily Number of Self-Reported Spray Doses|Week 2|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584662|NCT02355665|Secondary|Total Daily Number of Self-Reported Spray Doses at Week 1|Total Daily Number of Self-Reported Spray Doses|Week 1|Analysis was based on randomized participants who reported use data for at least 4 of the days in that week.|||Number of sprays||Standard Deviation|Mean
2584663|NCT02355665|Secondary|Aggregated Withdrawal Score at Week 6|Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28.|Week 6|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||units on a scale||Standard Deviation|Mean
2584664|NCT02355665|Secondary|Aggregated Withdrawal Score at Week 4|Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28.|Week 4|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||units on a scale||Standard Deviation|Mean
2584665|NCT02355665|Secondary|Aggregated Withdrawal Score at Week 2|Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28.|Week 2|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||units on a scale||Standard Deviation|Mean
2584666|NCT02355665|Secondary|Aggregated Withdrawal Score at Week 1|Participants were asked if during the last 24 hours they experienced each of 7 withdrawal symptoms on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so). The aggregated withdrawal symptom score was the sum of the scores of the 7 withdrawal symptoms (irritability-frustration-anger, restlessness, difficulty concentrating, anxiety, dysphoric or depressed mood, insomnia, and increased appetite). The total scores are reported with a minimum possible score of 0 and a maximum possible score of 28.|Week 1|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||units on a scale||Standard Deviation|Mean
2584667|NCT02355665|Secondary|Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 6|Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 6|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584668|NCT02355665|Secondary|Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 4|Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 4|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584669|NCT02355665|Secondary|Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 2|Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 2|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584670|NCT02355665|Secondary|Percentage Distribution of the Rating of Increased Appetite on a Categorical Scale at Week 1|Participants were asked if during the last 24 hours they experienced increased appetite on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 1|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584671|NCT02355665|Secondary|Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 6|Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 6|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584672|NCT02355665|Secondary|Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 4|Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 4|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584673|NCT02355665|Secondary|Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 2|Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 2|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584809|NCT02354235|Secondary|Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)|The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24.|0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks|Full analysis set|||hour*mg/dL||Standard Error|Least Squares Mean
2584674|NCT02355665|Secondary|Percentage Distribution of the Rating of Insomnia on a Categorical Scale at Week 1|Participants were asked if during the last 24 hours they experienced insomnia on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 1|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584675|NCT02355665|Secondary|Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 6|Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 6|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584676|NCT02355665|Secondary|Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 4|Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 4|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584677|NCT02355665|Secondary|Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 2|Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 2|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584678|NCT02355665|Secondary|Percentage Distribution of the Rating of Dysphoric or Depressed Mood on a Categorical Scale at Week 1|Participants were asked if during the last 24 hours they experienced dysphoric or depressed mood on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 1|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584679|NCT02355665|Secondary|Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 6|Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 6|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584680|NCT02355665|Secondary|Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 4|Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 4|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584681|NCT02355665|Secondary|Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 2|Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 2|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584682|NCT02355665|Secondary|Percentage Distribution of the Rating of Anxiety on a Categorical Scale at Week 1|Participants were asked if during the last 24 hours they experienced anxiety on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 1|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584683|NCT02355665|Secondary|Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 6|Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 6|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584684|NCT02355665|Secondary|Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 4|Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 4|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584685|NCT02355665|Secondary|Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 2|Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 2|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584686|NCT02355665|Secondary|Percentage Distribution of the Rating of Difficulty Concentrating on a Categorical Scale at Week 1|Participants were asked if during the last 24 hours they experienced difficulty concentrating on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 1|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584687|NCT02355665|Secondary|Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 6|Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 6|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584688|NCT02355665|Secondary|Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 4|Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 4|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584689|NCT02355665|Secondary|Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 2|Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 2|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584690|NCT02355665|Secondary|Percentage Distribution of the Rating of Restlessness on a Categorical Scale at Week 1|Participants were asked if during the last 24 hours they experienced restlessness on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 1|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584691|NCT02355665|Secondary|Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 6|Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 6|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584692|NCT02355665|Secondary|Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 4|Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 4|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584693|NCT02355665|Secondary|Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 2|Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 2|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584694|NCT02355665|Secondary|Percentage Distribution of the Rating of Irritability/Frustration/Anger on a Categorical Scale at Week 1|Participants were asked if during the last 24 hours they experienced irritability/frustration/anger on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 1|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584695|NCT02355665|Secondary|Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 6|Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 6|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584696|NCT02355665|Secondary|Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 4|Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 4|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584697|NCT02355665|Secondary|Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 2|Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 2|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584698|NCT02355665|Secondary|Percentage Distribution of the Rating of Desire/Urge to Smoke on a Categorical Scale at Week 1|Participants were asked if during the last 24 hours they experienced the desire/urge to smoke on a 5-grade categorical scale of 0 - 4 (where 0=not at all and 4=extremely so).|Week 1|Analysis was based on randomized participants verified abstinent from smoking since the last visit.|||Percentage of Participants|||Number
2584699|NCT02355665|Secondary|Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 20|Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking|Week 2 to Week 20|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584700|NCT02355665|Secondary|Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 16|Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking|Week 2 to Week 16|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584701|NCT02355665|Secondary|Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 8|Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking|Week 2 to Week 8|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584702|NCT02355665|Secondary|Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 4|Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking|Week 2 to Week 4|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584703|NCT02355665|Secondary|Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 26|Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking|Week 2 to Week 26|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584704|NCT02355665|Secondary|Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 12|Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking|Week 2 to Week 12|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584705|NCT02355665|Primary|Percentage of Participants With Continuous Smoking Abstinence From Week 2 to Week 6|Percentage of participants with carbon monoxide (CO)-verified self-report of continuous abstinence from smoking|Week 2 to Week 6|Analysis was based on the Full Analysis Set which included all randomized participants.|||Percentage of Participants|||Number
2584706|NCT02355275|Secondary|Numeric Pain Rating Scale|The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain. This was measured at baseline (T1) and 4 weeks (T2)|4 weeks||||units on a scale||Full Range|Mean
2584707|NCT02355275|Primary|Oswestry Disability Index|Patient disability was measured using the Oswestry Disability Index (OSW), a self-report outcome measure. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. The score is calculated by totaling the values marked, divided by 50 x 100. The greater the score the greater the disability. For example, 0% to 20% would be minimal disability and 81%-100% would be bed-bound. This outcome measure was reported at baseline (T1) and 4 weeks later (T2).|4 weeks||||units on a scale||Full Range|Mean
2584837|NCT02353806|Secondary|Neonatal Birth Weight|The neonatal weight at birth was collected.|Neonatal weight at the time of birth.||||grams||Standard Deviation|Mean
2584708|NCT02355158|Primary|Summary of Neuropathic Pain Symptom Inventory (NPSI)|The NPSI is a validated, self-administered questionnaire designed to evaluate the different symptoms of neuropathic pain. Each item is quantified on an 11-point (0-10) numeric scale. The NPSI includes 10 descriptors (plus 2 temporal items) that allow discrimination and quantification of 5 distinct clinically relevant dimensions of neuropathic pain syndromes. The Neuropathic Pain Symptom Inventory (NPSI) is a self-questionnaire designed to evaluate the different symptoms of neuropathic pain, which contains a list of descriptors reflecting spontaneous ongoing or paroxysmal pain, evoked pain (i.e., mechanical and thermal allodynia/hyperalgesia) and dysesthesia/paresthesia. Each of these items is quantified on an 11-point (0-10) numerical scale. NPSI total score was calculated and summarized descriptively at month 12 or the subjects last visit. The total score was calculated and summarized.|Month 12 or last visit|While 197 subjects received study drug, 172 completed the NPSI at the week 12 visit or at their last visit.|||units on a scale||Standard Deviation|Mean
2584709|NCT02355067|Secondary|Parenting Interactions With Children: Checklist of Observations Linked to Outcomes (PICCOLO)|The Parenting Interactions with Children: Checklist of Observations Linked to Outcomes is a checklist of 29 observable developmentally supportive parenting behaviors with children ages 10-47 months in four domains: affection, responsiveness, encouragement, and teaching. It is a positive, practical, versatile, culturally sensitive, valid, and reliable tool for practitioners that shows what parents can do to support their children's development. Currently, the PICCOLO is being validated for infants down to 6 months of age.|12 weeks||2020-09-30|09/2020||||
2584710|NCT02355067|Secondary|Parenting Sense of Competency (PSOC) Scale|The Parenting Sense of Competence scale measures parental competence on two dimensions: Satisfaction and Efficacy. It is a 17 item Likert-scale questionnaire (on a 6 point scale ranging from strongly agree [1] to strongly disagree [6]), with nine questions under Satisfaction and seven under Efficacy. Satisfaction section examines the parents' anxiety, motivation and frustration, while the Efficacy section looks at the parents' competence, capability levels, and problem-solving abilities in their parental role. Higher scores represent better parenting sense of competency. The full range of the score is 17-102.|12 weeks||||units on a scale||Full Range|Mean
2584711|NCT02355067|Secondary|Beck Depression Inventory (BDI-II)|The BDI-II is a 21-item self-report tool that measures the severity of depression and includes two subscales: cognitive and somatic. It has been well validated, with scores 14-19 indicating mild depression, 20-28 moderate depression, and 29-63 severe depression. The full range of the BDI-II is 0-64.|12 weeks||||units on a scale||Full Range|Mean
2584712|NCT02355067|Primary|Acceptability|Participants report concerning their overall program effects-Satisfaction Questionnaire. The scale ranges from 1-5 with higher values representing higher satisfaction.|12 weeks||||units on a scale||Full Range|Mean
2584713|NCT02355067|Primary|Attendance|Percentage of participants who attend each group session or check in online weekly. This is averaged over the course of the 8-week program.|8 weeks||||percentage of participants||Full Range|Mean
2584714|NCT02355028|Secondary|Plasma Concentration of LHA510 and CRA398|Samples collected from subjects, after multiple topical ocular dosing of LHA510, were analyzed to determine concentrations of LHA510 and its metabolite, CRA398. Plasma LHA510 and CRA398 concentrations were quantitated by a validated liquid chromatography-tandem mass spectroscopy assay method. Below the limit of quantification (BLQ) is treated as zero.|Day 28, Day 84|This analysis population includes all subjects who were treated with LHA510, had at least 1 serum sample following exposure to the IP, and had no known specimen collection or analytical deviations, as identified by the Pharmacokineticist, that would have affected the integrity of the data [Pharmacokinetics (PK) Analysis Set].|||ng/mL||Standard Deviation|Mean
2584715|NCT02355028|Secondary|Change From Randomization Visit (Day -1) in CNV Size by Visit|The size of CNV (area of new blood vessels in the choroid layer of the retina) was measured using FA and reported as a difference, in millimeter squared, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction, whereas a positive number indicates an increase. An increase in CNV size may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.|Day -1, Day 84|Extended PPS-A4 as observed|||mm^2||Standard Deviation|Mean
2584716|NCT02355028|Secondary|Change From Randomization Visit (Day -1) in Total Lesion Size by Visit|The total wet AMD lesion size was measured using FA and reported as a difference, in millimeter squared, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction, whereas a positive number indicates an increase. An increase in wet AMD lesion size may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.|Day -1, Day 84|Extended PPS-A4 as observed|||mm^2||Standard Deviation|Mean
2584717|NCT02355028|Secondary|Change From Randomization Visit (Day -1) in Pigment Epithelial Detachment - Foveal Involvement (PEDfi) Thickness by Visit|The thickness of pigment epithelial detachment involving the fovea was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness of pigment epithelial detachment involving the fovea may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.|Day -1, Day 28, Day 84|Extended PPS-A4. Missing Data Imputed Using LOCF.|||μm||Standard Deviation|Mean
2584718|NCT02355028|Secondary|Change From Randomization Visit (Day -1) in Subretinal Fluid - Foveal Involvement (SRFfi) Thickness by Visit|The thickness of subretinal fluid involving the fovea was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness of subretinal fluid involving the fovea may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.|Day -1, Day 28, Day 84|Extended PPS-A4. Missing Data Imputed Using LOCF.|||μm||Standard Deviation|Mean
2584719|NCT02355028|Secondary|Change From Randomization Visit (Day -1) in Lesion Thickness by Visit|The thickness of the neovascular lesion was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness of the neovascular lesion may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.|Day -1, Day 28, Day 84|Extended PPS-A4. Missing data imputed using LOCF.|||μm||Standard Deviation|Mean
2584720|NCT02355028|Secondary|Change From Randomization Visit (Day -1) in Central Subfield Thickness, Neuro-retina (CSFTnr) by Visit|The thickness of the neuro-retina, at the level of the central subfield, was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.|Day -1, Day 28, Day 84|Extended PPS-A4. Missing data imputed using LOCF.|||μm||Standard Deviation|Mean
2584721|NCT02355028|Secondary|Change From Randomization Visit (Day -1) in Best Corrected Visual Acuity (BCVA) at All Visits at the Study Site|Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity was conducted in each eye individually using ETDRS charts and reported in number of letters read correctly. An increase (gain) in letters read from the baseline assessment indicates improvement. Only one eye (study eye) contributed to the analysis.|Day -1, Day 14, Day 28, Day 56, Day 84|Extended PPS-A4. Missing Data Imputed Using LOCF.|||letters||Standard Error|Least Squares Mean
2584722|NCT02355028|Secondary|Change From Randomization Visit (Day -1) in Central Subfield Thickness Total (CSFTtot) at All Visits at the Study Site|The thickness of the retina was measured using SD-OCT and reported as a difference, in micrometers, between a given post-Randomization Visit and Randomization Visit (Day-1). A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness may indicate a progression of the underlying disease. Only one eye (study eye) contributed to the analysis.|Day -1, Day 14, Day 28, Day 56, Day 84|Extended PPS-A4. Missing data imputed using the Last Observation Carried Forward (LOCF) approach.|||μm||Standard Error|Least Squares Mean
2584723|NCT02355028|Secondary|Number of Subjects Requiring LUCENTIS® Retreatment at Days 28 and 56|The number of LUCENTIS® retreatment needs identified before or at the Day 28 and Day 56 visits (even if retreatment was applied at a later visit) for each subject was used in the analysis.|Day 28, Day 56|Extended PPS-A4|||Participants|||Count of Participants
2584724|NCT02355028|Secondary|Number of LUCENTIS® Retreatment Needs Identified Required up to Day 84|The number of LUCENTIS retreatment needs identified before or at the Day 84 visit (even if retreatment was applied at a later visit) for each patient was used in the analysis|Up to Day 84|Extended PPS-A4|||participants|||Number
2584725|NCT02355028|Secondary|Time to First LUCENTIS® Retreatment Need Identification up to Day 84|The time was determined based on the visit of the treatment period when a patient was identified as requiring retreatment with LUCENTIS.|Day 14, Day 28, Day 56, Day 84|Extended PPS-A4 who required retreatment|||Participants|||Count of Participants
2584726|NCT02355028|Primary|Number of Subjects With Positive LUCENTIS® Retreatment Status at Day 84|For subjects who completed the Day 84 visit, retreatment need status was positive if LUCENTIS® retreatment (injection) was required before or at Day 84, including requiring retreatment at or before the Day 84 visit with the actual retreatment performed at a later visit.|Day 84|Extended PPS-A4|||Participants|||Count of Participants
2584727|NCT02354976|Secondary|Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Fenofibrate)|To evaluate the efficacy of Epanova compared to Fenofibrate with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment.|12 weeks|The Full Analysis Set included all randomized patients, regardless of whether they took study medication or not. In this set, patients were analyzed according to their randomized treatment assignment.|||ratio of % liver fat||95% Confidence Interval|Geometric Mean
2584728|NCT02354976|Primary|Geometric Mean Ratio (Week 12/Baseline) of % Liver Fat as Assessed by MRI (Epanova Versus Placebo)|To evaluate the efficacy of Epanova compared to placebo with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment.|Baseline and 12 weeks|The Full Analysis Set included all randomized patients, regardless of whether they took study medication or not. In this set, patients were analyzed according to their randomized treatment assignment.|||ratio of % liver fat||95% Confidence Interval|Geometric Mean
2584729|NCT02354924|Secondary|Symptoms, Problems and Complaints and Incidence Rate|Subjective Responses to comfort/symptoms/complaints were measured at every visit. 1=Severe Burning to 10=No Burning for each eye|3 month||||eye|eye||Count of Units
2584730|NCT02354924|Secondary|Slit Lamp Findings|Any slit lamp finding > Grade 2; Measured on a scale of 0-4 with 0=no findings and 4=severe findings|3 month||||eye|eye||Count of Units
2584731|NCT02354924|Primary|Visual Acuity|Visual acuity correctable to snellen 20/25 or better|3 months||||eye|eye||Count of Units
2584732|NCT02354859|Secondary|Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CFRSD-CRISS), From Baseline to Day 56|Difference between treatment groups in the absolute change in respiratory symptoms, as measured by the the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CFRSD-CRISS), from Baseline to Day 56. The Cystic Fibrosis Respiratory Symptoms Daily Diary asks a participant to state the extent of their 8 respiratory symptoms : difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present 'a great deal' or 'extremely'. A summed score (range from 0-24) is calculated for each participant and converted to a final score with a range of 0 to 100, where the lowest scores indicate improvement of symptoms.|Day 1 to Day 56||||score on a scale||Standard Error|Mean
2584733|NCT02354859|Secondary|Absolute Change in P. Aeruginosa Sputum Density (log10 (CFU)) From Baseline to Day 56|Difference between treatment groups in the absolute change in P. aeruginosa sputum density (log10 (CFU)) from Baseline to Day 56 based on quantitative cultures.|Day 1 to Day 56|Includes only participants with a positive P. aeruginosa (Pa) culture at Baseline.|||log10 (CFU)||Standard Error|Mean
2584734|NCT02354859|Secondary|Relative Change in FEV1 (Liters) From Baseline to Day 56|Difference between treatment groups in the relative change in FEV1 (liters) from Baseline to Day 56|Day 1 to Day 56||||percentage change||Standard Error|Mean
2584735|NCT02354859|Secondary|Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)|Rate is defined as the number of events per participant follow-up week.|Day 1 to Day 56||||events per participant-week|||Number
2585196|NCT02348203|Secondary|Change in Urinary LTE (4) Levels|Two sample t tests will be performed to evaluate whether or not there are significant differences in changes in LTE(4) between the treatment and placebo groups.|Baseline up to week 12|||||||
2584737|NCT02354859|Primary|Number of Participants With 5% or Greater Relative Change in FEV1 (Liters) From Baseline to Day 28|Difference between treatment groups in the proportion of subjects with 5% or greater relative change in FEV1 (liters) from baseline to Day 28.|Baseline to Day 28|Includes only treated participants with FEV1 measurements at Baseline and Day 28.|||Participants|||Count of Participants
2584738|NCT02354833|Primary|Median Total Rescue Bolus Dose of Phenylephrine (mcg) to Maintain SBP||At time of surgery, up to 2 hours||||mcg||Full Range|Median
2584739|NCT02354833|Primary|Median Total Rescue Bolus Dose of Ephedrine (mg) to Maintain SBP||At time of surgery, up to 2 hours||||mg||Full Range|Median
2584740|NCT02354833|Secondary|Percentage of Participants Experiencing Both Nausea and Emesis||At time of surgery, up to 2 hours||||percentage of participants||95% Confidence Interval|Number
2584741|NCT02354833|Primary|Number of Rescue Boluses to Maintain SBP|Number of rescue boluses to maintain the SBP within 100-120% of baseline|At time of surgery, up to 2 hours||||rescue boluses|||Number
2584742|NCT02354781|Secondary|Muscle Function Measured by North Star Ambulatory Assessment (NSAA)|"Overall Improvement in North Star Ambulatory Assessment~The activities are graded as follows:~2 - Normal - no obvious modification of activity~1 - Modified method but achieves goal independent of physical assistance from another 0 - Unable to achieve independently This scale is ordinal with 34 as the maximum score indicating fully-independent function."|2 years|Participants enrolled who receive a single dose of 2.4E12 vg/kg (1.2E12vg/kg/limb) of rAAV1.CMV.huFollistatin344.|||Participants|||Count of Participants
2584743|NCT02354781|Secondary|Expression of Viral DNA (qPCR), and Follistatin Transgene in Muscle Tissue|"Muscle biopsies on quadriceps muscles a muscle biopsy on one leg at baseline screening visit and the post gene transfer biopsy on the opposite leg at day 180. Muscle tissue obtained at biopsy will also be assessed for viral DNA (qPCR), and follistatin transgene expression.~Measured in CMV.FS344 Gene Copy Number in Genomic DNA (Copies/ug DNA)"|180.days|Participants enrolled will receive a single dose of 2.4E12 vg/kg (1.2E12vg/kg/limb) of rAAV1.CMV.huFollistatin344 delivered to the lower limbs|||Participants|||Count of Participants
2584744|NCT02354781|Secondary|Muscle Function Measured by Six-minute Walk Test (6MWT)|Number of subjects with increased distance walked in meters on the Six Minute Walk Test The participant was asked to walk a set course of 25 meters for 6 minutes (timed) and the distance walked in meters was recorded. Increases from baseline in 6MWT distance are indicative of improvement and decreases from baseline indicate worsening.|2 years|Participants enrolled will receive a single dose of 2.4E12 vg/kg (1.2E12vg/kg/limb) of rAAV1.CMV.huFollistatin344 delivered to the lower limbs|||Participants|||Count of Participants
2584745|NCT02354781|Primary|Number of Dose Limiting Toxicity (DLT) Adverse Events as Assessed by 21 CFR 312.32.|"Dose limiting toxicity (DLT) is defined as any adverse event that is possibly, probably, or definitely related to the study agent. This would include any grade 3 according to the classification given above. Study enrollment will be halted by the investigators when any subject experiences a Grade 3, or higher adverse event toxicity that is possibly, probably, or definitely related to the study drug. Only those adverse events requiring treatment will qualify as DLT.~The classification for adverse events to be used is the following:~Mild adverse event; did not require treatment~Moderate adverse event; resolved with treatment~Severe adverse event; inability to carry on normal activities; required professional medical attention~Life-threatening or permanently disabling adverse event~Fatal adverse event In this grading system, severe is not equivalent to seriousness."|DLT Adverse events will be recorded from the date of dosing and through the time of the subject's last study visit. Serious adverse events will be recorded from the date of dosing and for up to 2 years after gene therapy administration.|Safety Population: All subjects who receive a single total dose of 2.4E12 vg/kg (1.2E12vg/kg/limb) of rAAV1.CMV.huFollistatin344.|||Number of Events|||Number
2584746|NCT02354690|Secondary|Progression Free Survival|"Progression-free survival (PFS), defined as the time from start of treatment to disease progression, relapse or death due to any cause, whichever is earlier, will be described with the Kaplan-Meier curve.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|Up to 40 months||||Months||Full Range|Median
2584747|NCT02354690|Secondary|Overall Survival|Overall survival (OS), defined as the time from the start of treatment to death, will be described with the Kaplan-Meier curve.|Up to 40 months||||Months||Full Range|Median
2584748|NCT02354690|Secondary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 12 months||||Participants|||Count of Participants
2584749|NCT02354690|Secondary|Treatment Related Immune Responses|"Number of patients whose infusion product contained anti-tumor reactive T cells by in vitro testing.~Anti-tumor reactive T cells is defined by positive staining for two of the three markers (interferon gamma, tumor necrosis factor alpha and CD107a) in an intracellular cytokine staining using flow cytometry."|0-24 weeks||||Participants|||Count of Participants
2584750|NCT02354690|Primary|Number of Reported Adverse Events|Determine the safety of the administration of vemurafenib in combination with TIL therapy including lymphodepleting chemotherapy and interleukin-2 treatment by collecting adverse events according to CTCAE v. 4.0. From start of treatment until 24 weeks after T cell infusion.|0-40 weeks||||Treatment related adverse events|||Number
2584751|NCT02354599|Secondary|Number of Participants With Positive Response for Anti MT203 Antibody||Baseline, Hour 168, 336, Day 42, 84|The safety analysis set was defined as all participants who received the study medication.|||participants|||Number
2584752|NCT02354599|Secondary|Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration||Baseline, Hour 24, 72, 120, 168, 240, 336 hours, Day 21, 28, 42, 56, 70, 84|The pharmacodynamic analysis set was defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacodynamic data.|||picogram per milliliter (pg/mL)||Standard Deviation|Mean
2584753|NCT02354599|Secondary|Terminal Elimination Half-Life (T1/2) of MT203||Predose and at multiple time points (up to 84 days) post-dose|The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.|||day||Full Range|Median
2584754|NCT02354599|Secondary|Maximum Observed Serum Concentrations (Cmax) of MT203||Predose and at multiple time points (up to Day 84) post-dose|The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2584755|NCT02354599|Secondary|Area Under the Serum Concentration-Time Curve From Time 0 to Time 84 Days (AUC(0-84d)) of MT203||Predose and at multiple time points (up to 84 days) post-dose|The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.|||ng*day/mL||Standard Deviation|Mean
2584756|NCT02354599|Secondary|Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf)) of MT203||Predose and at multiple time points (up to 84 days) post-dose|The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.|||nanogram*day per milliliter (ng*day/mL)||Standard Deviation|Mean
2584757|NCT02354599|Primary|Number of Participants With TEAEs Related to Hematology, Serum Chemistry and Urinalysis||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.|||participants|||Number
2584758|NCT02354599|Primary|Number of Participants With TEAEs Related to Lung Functioning Monitoring||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.|||participants|||Number
2584759|NCT02354599|Primary|Number of Participants With TEAEs Related to 12-lead Electrocardiograms (ECG)||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.|||participants|||Number
2584760|NCT02354599|Primary|Number of Participants With TEAEs Related to Body Weight||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.|||participants|||Number
2584761|NCT02354599|Primary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.|||participants|||Number
2584762|NCT02354599|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)||Baseline up to Day 85|The safety analysis set was defined as all participants who received the study medication.|||participants|||Number
2584763|NCT02354586|Other Pre-specified|Number of Participants Who Were Administered Concomitant Medications|Number of participants who were administered concomitant medications were planned to be analyzed.|Up to 3 years|Safety population. This was an other pre-specified outcome measure. Data will not be analyzed and reported.||||||
2584764|NCT02354586|Other Pre-specified|Number of Participants With Abnormality in Physical Examination|Number of participants with abnormality in physical examination were planned to be analyzed.|Up to 3 years|Safety population. This was an other pre-specified outcome measure. Data will not be analyzed and reported.||||||
2584765|NCT02354586|Other Pre-specified|Number of Participants With Abnormality in Vital Signs|Number of participants with abnormality in vital signs were planned to be analyzed.|Up to 3 years|Safety population. This was an other pre-specified outcome measure. Data will not be analyzed and reported.||||||
2584766|NCT02354586|Other Pre-specified|Number of Participants With Abnormality in Clinical Chemistry Parameters|Number of participants with abnormality in clinical chemistry parameters were planned to be analyzed.|Up to 3 years|Safety population. This was an other pre-specified outcome measure. Data will not be analyzed and reported.||||||
2584767|NCT02354586|Other Pre-specified|Number of Participants With Abnormality in Hematology Parameters|Number of participants with abnormality in hematology parameters were planned to be analyzed.|Up to 3 years|Safety population. This was an other pre-specified outcome measure. Data will not be analyzed and reported.||||||
2584768|NCT02354586|Other Pre-specified|Number of Participants With Any Non-serious Adverse Event (Non-SAE) or Any SAE|An adverse event is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with study treatment. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE.|Up to 3 years|Safety population was defined as all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2584769|NCT02354586|Secondary|Time to First Subsequent Therapy (TFST)|Time to first subsequent therapy (TFST) was defined as the time from the date of first dose to the date of first subsequent therapy or death, whichever occurs first. It was calculated as (Earlier of [First dose of first subsequent therapy or death] minus First dose date plus 1) divided by 30.4375.|Up to 3 years|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Months||95% Confidence Interval|Median
2584770|NCT02354586|Secondary|Overall Survival|Overall Survival was defined as the time from the date of the first dose to the date of death by any cause. It was calculated as [Date of Death minus First dose date plus 1] divided by 30.4375.|Up to 3 years|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Months||95% Confidence Interval|Median
2584771|NCT02354586|Secondary|Progression Free Survival|Progression-free survival was defined as the time from the date of first dose to the earlier date of assessment of progression or death by any cause in the absence of progression as assessed by the Investigator per RECIST (version 1.1) or clinical criteria.|Up to 3 years|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Months||95% Confidence Interval|Median
2584772|NCT02354586|Secondary|Disease Control Rate (DCR)|Disease control rate was defined as the percentage of participants achieving CR, PR, or stable disease (SD) as assessed by the Investigator per RECIST (version1.1). The exact (Clopper-Pearson) method was used to calculate 95% confidence interval.|Up to 3 years|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Percentage of participants||95% Confidence Interval|Number
2585197|NCT02348203|Secondary|Change in Urinary PGE-M Levels|Two sample t tests will be performed to evaluate whether or not there are significant differences in changes in PGE-M between the treatment and placebo groups.|Baseline up to week 12|||||||
2584773|NCT02354586|Secondary|ORR by HRD Status and Breast Cancer Gene (BRCA) Status|The ORR was defined as the percentage of participants achieving CR or PR as assessed by the Investigator per RECIST (version1.1). ORR was evaluated for participants with following characteristics: HRD status (positive, negative and unknown) and BRCA status (mutation positive, wild-type and unknown).|Up to 3 years|ITT Population. All the participants from the ITT Population were analyzed (461 participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Percentage of participants||95% Confidence Interval|Number
2584774|NCT02354586|Secondary|Duration of Response (DoR)|DoR was defined as the time from first documentation of CR or PR until the time of first documentation of disease progression (PD) as assessed by the Investigator per RECIST (version1.1). DoR was analyzed using Kaplan-Meier (KM) method.|Up to 3 years|Intent-to-Treat (ITT) population was comprised of all dosed participants with measurable disease at Baseline. Measurable disease at Baseline was determined by the existence of at least 1 target lesion at Baseline tumor scan based on investigator’s assessment. Only those participants with data available at the specified time points were analyzed.|||Months||95% Confidence Interval|Median
2584775|NCT02354586|Primary|Objective Response Rate (ORR)|The ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) (version1.1). Primary Analysis Population comprised of participants who received 3 or 4 prior lines of therapy (LOT), had homologous recombination deficiency positive (HRDpos) tumors, had platinum-sensitive disease, and were poly(adenosine 5'-diphosphate [ADP]-ribose) polymerase inhibitors (PARPi) naïve.|Up to 3 years|Primary Analysis Population. Only those participants with data available at the specified time points were analyzed.|||Percentage of participants||95% Confidence Interval|Number
2584776|NCT02354508|Secondary|Extension Phase: Change From Baseline in EQ-5D-5L VAS Assessment|"Evaluation of effect of pasireotide LAR on health status, measured by EQ-5D-5L, a valid and reliable instrument for measuring general health status. The EQ-5D-5L consists of 2 pages - the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20-cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. This scale is numbered from 0 to 100. 100 means the best health you can imagine.~0 means the worst health you can imagine."|Baseline, Weeks 48, 60 & 72|Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.|||scores on a scale||Standard Deviation|Mean
2584777|NCT02354508|Secondary|Extension Phase: Change From Baseline in EQ-5D-5L Index Scores|"Evaluation of effect of pasireotide LAR on health status, measured by EQ-5D-5L, a valid and reliable instrument for measuring general health status. The EQ-5D-5L consists of 2 pages - the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20-cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. This scale is numbered from 0 to 100. 100 means the best health you can imagine.~0 means the worst health you can imagine."|Baseline, Weeks 48, 60 & 72|Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.|||scores on a scale||Standard Deviation|Mean
2584778|NCT02354508|Secondary|Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline|Symptoms of acromegaly were collected at various visits. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).|Weeks 48, 60 & 72|Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.|||Percentage of participants|||Number
2584779|NCT02354508|Secondary|Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms|Symptoms of acromegaly were collected at various visits. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).|Weeks 48, 60 & 72|Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.|||Percentage of participants|||Number
2584780|NCT02354508|Secondary|Extension Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL)|Evaluation of effect of pasireotide LAR on Health Related Quality of Life (HRQoL) was assessed using AcroQoL, an acromegaly-specific quality of life instrument. The AcroQol instrument is comprised of 22 questions divided into two scales: one evaluating physical aspects (8 items) and the other that addresses psychological aspects (14 items). The psychological scale can also be further divided into subscale that evaluates physical appearance and the other subscale focused on the impact of the disease on personal relationships of the patient (7 items each). Each of the questions has a 5-item Likert scale. For each dimension the scores range from 0-4 with 0 being the lowest impact and 4 being the most severe.|Baseline, Weeks 48, 60 & 72|Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.|||scores on a scale||Standard Deviation|Mean
2584781|NCT02354508|Secondary|Extension Phase: Percentage of Participants With Mean GH < 1 μg/L at Weeks 48, 60, 72 and Overall, Pasireotide Montherapy and Pasireotide With Concomittant Medication and by GH Level at Screening|Percentage of patients achieving GH <1 μg/L and IGF-1 <ULN at week 48 by treatment with pasireotide LAR alone or with concomitant medications used to treat acromegaly|Weeks 48, 60, 72|Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.|||Percentage of participants||95% Confidence Interval|Number
2584793|NCT02354508|Secondary|Core Phase: Change in Mean Growth Hormone (GH) Values From Baseline to Week 36|Core phase - Changes in mean GH from study baseline to week 36.|Baseline, week 36|FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.|||percentage change||Standard Deviation|Mean
2584782|NCT02354508|Secondary|Extension Phase: Percentage of Participants With Mean GH < 1 μg/L and IGF-1 < ULN at Weeks 48, 60 and 72 (Overall by Baseline Diabetic Status)|Percentage of participants achieving IGF-1 <ULN at week 46, 60 and 72 overall by baseline diabetic status|Weeks 48, 60, 72|Extension FAS included all the patients who received at least one dose of pasireotide LAR in the extension phase.|||Percentage of participants||95% Confidence Interval|Number
2584783|NCT02354508|Secondary|Extension Phase: Percentage of Participants With Mean GH < 1 μg/L and IGF-1 < ULN at Weeks 48, 60 & 72 (Up-titrated to Pasireotide LAR 60 mg)|Percentage of patients achieving IGF-1 <ULN at weeks 48, 60 & 72 for participants with up-titrated to Pasireotide LAR 60 mg mg|Weeks 48, 60 & 72|Extension Full Analysis Set (Extension FAS) included all the patients who received at least one dose of pasireotide LAR in the extension phase.|||Percentage of participants||95% Confidence Interval|Number
2584784|NCT02354508|Secondary|Core Phase: Change From Baseline in EQ-5D-5L VAS Assessment|"Evaluation of effect of pasireotide LAR on health status, measured by EQ-5D-5L, a valid and reliable instrument for measuring general health status. The EQ-5D-5L consists of 2 pages - the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20-cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. This scale is numbered from 0 to 100. 100 means the best health you can imagine.~0 means the worst health you can imagine."|Baseline, Weeks 12, 24 & 36|FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study|||scores on a scale||Standard Deviation|Mean
2584785|NCT02354508|Secondary|Core Phase: Change From Baseline in EQ-5D-5L Index Scores|"Evaluation of effect of pasireotide LAR on health status, measured by EQ-5D-5L, a valid and reliable instrument for measuring general health status. The EQ-5D-5L consists of 2 pages - the descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20-cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'. This scale is numbered from 0 to 100. 100 means the best health you can imagine.~0 means the worst health you can imagine."|Baseline, Weeks 12, 24 & 36|FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study|||scores on a scale||Standard Deviation|Mean
2584786|NCT02354508|Secondary|Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline|Symptoms of acromegaly were collected at various visits. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).|Weeks 12, 24 & 36|FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study|||Percentage of participants|||Number
2584787|NCT02354508|Secondary|Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms|Symptoms of acromegaly were collected at various visits. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).|Weeks 12, 24 & 36|FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study|||Percentage of participants|||Number
2584788|NCT02354508|Secondary|Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL)|Evaluation of effect of pasireotide LAR on Health Related Quality of Life (HRQoL) was assessed using AcroQoL, an acromegaly-specific quality of life instrument. The AcroQol instrument is comprised of 22 questions divided into two scales: one evaluating physical aspects (8 items) and the other that addresses psychological aspects (14 items). The psychological scale can also be further divided into subscale that evaluates physical appearance and the other subscale focused on the impact of the disease on personal relationships of the patient (7 items each). Each of the questions has a 5-item Likert scale. For each dimension the scores range from 0-4 with 0 being the lowest impact and 4 being the most severe.|Baseline, Weeks 12, 24 & 36|FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study|||scores on a scale||Standard Deviation|Mean
2584789|NCT02354508|Secondary|Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN Overall by Baseline Diabetic Status|Core phase - Percentage of patients achieving GH <1μg/L at week 12, 24, 36 overall and by GH level at screening.|Weeks 12, 24 & 36|FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.|||Percentage of participants||95% Confidence Interval|Number
2584790|NCT02354508|Secondary|Core Phase: Percentage of Participants With IGF-1 <ULN Overall by GH Level at Screening|Percentage of participants achieving IGF-1 <ULN at weeks 12, 24 & 36.|Weeks 12, 24 & 36|FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study|||Percentage of participants||95% Confidence Interval|Number
2584791|NCT02354508|Secondary|Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1 <ULN|Percentage of participants achieving GH <1 μg/L and IGF-1 <ULN at weeks 12 and 24 overall and by GH level at screening.|Week 12, Week 24, Week 36|FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.|||Percentage of participants||95% Confidence Interval|Number
2584792|NCT02354508|Secondary|Core Phase: Change in Standardized IGF-1 Values From Baseline to Week 36|Core phase - Changes in standardized IGF-1 from study baseline to week 36.|Baseline, week 36|FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.|||percentage change||Standard Deviation|Mean
2584794|NCT02354508|Primary|Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall - LOCF|Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36, by previous treatment and overall - last observation carried forward (LOCF)|Week 36|Full Analysis Set (FAS) comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.|||Percentage of participants||95% Confidence Interval|Number
2584795|NCT02354508|Primary|Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 Overall by Baseline Diabetic Status|Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36, overall by baseline diabetic status.|Week 36|Full Analysis Set (FAS) comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.|||Percentage of participants||95% Confidence Interval|Number
2584796|NCT02354508|Primary|Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 for Participants Up-titrated to Pasireotide LAR 60 mg|Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36, for participants who had been up-titrated with pasireotide LAR 60 mg.|Week 36|Full Analysis Set (FAS) comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study. For these patients the Pasireotide LAR dose was uptitrated to 60 mg any time during the study.|||Percentage of participants||95% Confidence Interval|Number
2584797|NCT02354508|Primary|Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36|Percentage of patients who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36, by previous treatment, type of therapy and overall.|Week 36|Full Analysis Set (FAS) comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.|||Percentage of participants||95% Confidence Interval|Number
2584798|NCT02354508|Primary|Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36|Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36.|Wek 36|Per-Protocol Set (PPS): consisted of a subset of the patients in the FAS who were compliant with requirements of the clinical study protocol. The protocol deviations criteria were defined prior to database lock. Per-protocol analysis was performed during the core phase, but not during the extension phase.|||Percentage of participants||95% Confidence Interval|Number
2584799|NCT02354508|Primary|Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 for Participants Up-titrated to Pasireotide LAR 60 mg|Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36, for participants who had been up-titrated with pasireotide LAR 60 mg.|Week 36|Full Analysis Set (FAS) comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study. For these patients the Pasireotide LAR dose was uptitrated to 60 mg before Week 36.|||Percentage of participants||95% Confidence Interval|Number
2584800|NCT02354508|Primary|Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall|Percentage of participants who achieved biochemical control defined as GH <1μg/L and IGF-1 <ULN at week 36.|Week 36|Full Analysis Set (FAS) comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study.|||Percentage of participants||95% Confidence Interval|Number
2584801|NCT02354482|Primary|Emergency Department (ED) Visit|Visit to the ED within 30 days of hospital discharge.|30 days post hospital discharge|Any individual participant may have experienced more than one group; therefore, the sum of participants across the arms exceeds the total sample size. Results data are shown for the entire arm (overall) and are also broken down into subgroups.|||Odds Ratio||95% Confidence Interval|Number
2584802|NCT02354482|Primary|Hospital Readmission|Readmission to the hospital within 30 days of discharge.|30 days post hospital discharge|Any individual participant may have experienced more than one group; therefore, the sum of participants across the arms exceeds the total sample size. Results data are shown for the entire arm (overall) and are also broken down into subgroups.|||odds ratio||95% Confidence Interval|Number
2584803|NCT02354443|Primary|Safety Profile, Assessed Primarily by Neutrophil Engraftment||Engraftment by Day 42 following study transplant procedure||||Participants|||Count of Participants
2584804|NCT02354417|Primary|Safety Profile, Primarily Assessed by Neutrophil Engraftment|To describe the safety profile of ProHema-CB after myeloablative conditioning in pediatric patients with hematologic malignancies. The safety profile will primarily be assessed by neutrophil engraftment.|Neutrophil engraftment by Day 42||||Participants|||Count of Participants
2584805|NCT02354378|Secondary|Memory Threshold|At the presentation of each picture, the child will be asked whether or not he/she remembers having seen it previously. Each response will be coded as correct (true positives and true negatives) or incorrect (false positives and false negatives)|Until 100 cards have been presented to the child. Approx. 10 minutes.||||Number of Memory Cards seen before scan||Standard Deviation|Mean
2584806|NCT02354378|Primary|Sedation Threshold|During the 10-minute bolus infusion of Dexmedetomidine, children will be presented with pictures at 5-second intervals and asked to name the picture. They will be asked to name each picture (e.g., cat, tree, pencil, etc.). A valid response is naming of the picture within 5 seconds, either correctly or incorrectly.The important response measure is whether the child is awake enough to perform the naming task.|Until the child has reviewed cards and is under sedation or for the control group has reviewed 100 cards||||Number of Memory Cards||Standard Deviation|Mean
2584807|NCT02354352|Primary|Left Ventricular Strain|a sensitive measure of heart muscle function|12 months|One patient in the spironolactone group did not receive a follow-up MRI.|||Percent change in circumference||Inter-Quartile Range|Median
2584808|NCT02354235|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose Level|The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24.|2 Hours Postprandial, at Baseline and 24 Weeks|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
2584984|NCT02351167|Secondary|Longitudinal Models of Abstinence Outcomes Across Multiple Time Points|The definition of this measure requires; no self-reported smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment.|0-52 Weeks||2020-08-31|08/2020||||
2584810|NCT02354235|Secondary|Percentage Change in Body Weight From Baseline|The percentage change from baseline in body weight collected at Week 24.|Baseline, 24 Weeks|Full analysis set, last observation carried forward. Outcome measure for one patient of each group was not assessed at a certain timepoint due to dropout.|||percent change||Standard Error|Least Squares Mean
2584811|NCT02354235|Secondary|Change From Baseline in Fasting Plasma Glucose Level|The change from baseline in fasting plasma glucose level collected at Week 24.|Baseline, 24 Weeks|Full analysis set, last observation carried forward. Outcome measure for one patient of each group was not assessed at a certain timepoint due to dropout.|||mg/dL||Standard Error|Least Squares Mean
2584812|NCT02354235|Primary|Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)|The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24.|Baseline, 24 Weeks|Full analysis set, last observation carried forward|||percentage of HbA1c||Standard Error|Least Squares Mean
2584813|NCT02354222|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose Level|The change from baseline in 2-hour postprandial plasma glucose level collected at Week 24.|2 Hours Postprandial, at Baseline and 24 Weeks|Full analysis set. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.|||mg/dL||Standard Error|Least Squares Mean
2584814|NCT02354222|Secondary|Change From Baseline in the AUC(0-2h) for Postprandial Plasma Glucose (PPG)|The change from Baseline in AUC(0-2h) for Postprandial Plasma Glucose collected at Week 24.|0, 0.5, 1 and 2 hour postprandial, at Baseline and 24 Weeks|Full analysis set. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.|||hour*mg/dL||Standard Error|Least Squares Mean
2584815|NCT02354222|Secondary|Percentage Change in Body Weight From Baseline|The percentage change from baseline in body weight collected at Week 24.|Baseline, 24 Weeks|Full analysis set, last observation carried forward. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.|||percent change||Standard Error|Least Squares Mean
2584816|NCT02354222|Secondary|Change From Baseline in Fasting Plasma Glucose Level|The change from baseline in fasting plasma glucose level collected at Week 24.|Baseline, 24 Weeks|Full analysis set, last observation carried forward. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.|||mg/dL||Standard Error|Least Squares Mean
2584817|NCT02354222|Primary|Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)|The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24.|Baseline, 24 Weeks|Full analysis set, last observation carried forward|||percentage of HbA1c||Standard Error|Least Squares Mean
2584818|NCT02354092|Secondary|Pain With Overall Dilator Placement|"Measure of distance (mm) from the left (no pain) on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded 15 minutes after osmotic dilator placement. mm=No Pain and 100 mm= worst possible pain. A higher mean score indicates a higher level of pain experienced at this time point."|15 minutes after dilator placement||||units on a scale||Standard Deviation|Mean
2584819|NCT02354092|Secondary|Reported Pain at Baseline|"Measure of distance (mm) from the left (no pain) on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) of pain recorded at baseline prior to the paracervical block or sham block procedure. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain."|Baseline, just prior to PCB or sham procedure||||units on a scale||Standard Deviation|Mean
2584820|NCT02354092|Secondary|Pain With Paracervical Block or Sham|"Measure of distance (mm) from the left (no pain) on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded at time immediately after last injection for paracervical block OR script for sham injection. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain."|Within 5 minutes after baseline||||units on a scale||Standard Deviation|Mean
2584821|NCT02354092|Primary|Pain at Time of Osmotic Dilator Placement|"Measure of distance (mm) from the left (no pain) on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded at time immediately after osmotic dilator placement. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain."|Within 5 minutes of PCB or sham procedure||||units on a scale||Standard Deviation|Mean
2584822|NCT02353871|Secondary|The Time to Onset of Treatment Response Based on the Subject's Diary Card.|Median time to onset of treatment response: subjects asked to record their assessment of study treatment response in a diary card on Days 1 to 7. They responded 'yes' or 'no' to the following question: 'since being injected have you noticed an improvement in the appearance of your glabellar lines (lines between your eyebrows)?'|Day 1 to 7|mITT: All randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. One subject from the placebo group was excluded from the analysis due to missing data.|||Days||95% Confidence Interval|Median
2584823|NCT02353871|Secondary|The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Level of Satisfaction With the Appearance of Their Glabellar Lines.|"Adjusted proportion of responders at each post-treatment visit (measured by the subject's level of satisfaction with the appearance of their glabellar lines).~4-point categorical scale: Grade 0 - very satisfied; Grade 1 - satisfied; Grade 2 - dissatisfied; Grade 3 - very dissatisfied.~A responder was defined as having a satisfaction rating of very satisfied (Grade 0) or satisfied (Grade 1) at a given visit and a satisfaction rating of dissatisfied (Grade 2) or very dissatisfied (Grade 3) at Baseline (Day 1).~The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 8, 15, 29, 57, 85, 113, 148 and 183|mITT: All randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.|||Adjusted percentage of responders||95% Confidence Interval|Number
2584834|NCT02353806|Secondary|Major Infant Complications|Any major complications experienced by infants born to women taking amlodipine besylate including NICU admission, intraventricular hemorrhage, neonatal seizures, need for respiratory support and apnea were collected.|During neonatal hospitalization||||Participants|||Number
2584835|NCT02353806|Secondary|Infant Length of Stay.|The length of stay of infants born to women taking amlodipine besylate will be collected.|Time from birth to hospital discharge||||Days||Standard Deviation|Mean
2584824|NCT02353871|Secondary|The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Self-assessment (SSA) at Maximum Frown.|"SSA~4-point photographic scale: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles - 3.~A responder at maximum frown was defined as having a severity grade of no wrinkles (Grade 0) or mild wrinkles (Grade 1) at maximum frown at a given visit and a severity grade of moderate wrinkles (Grade 2) or severe wrinkles (Grade 3) at Baseline (Day 1).~The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 8, 15, 29, 57, 85, 113, 148 and 183|mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.|||Adjusted percentage of responders||95% Confidence Interval|Number
2584825|NCT02353871|Secondary|The Proportion of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Maximum Frown.|"ILA~4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3.~Adjusted proportion of subjects with a reduction of two or more grades in the severity of glabellar lines at each post-treatment visit compared with Baseline.~The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 8, 15, 29, 57, 85, 113, 148 and 183|mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.|||Adjusted percentage of responders||95% Confidence Interval|Number
2584826|NCT02353871|Secondary|The Proportion of Responders at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Rest.|"ILA~4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3.~A responder at rest was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at rest at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1).~The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 8, 15, 29, 57, 85, 113, 148 and 183|mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit.; P=placebo.|||Adjusted percentage of responders||95% Confidence Interval|Number
2584827|NCT02353871|Secondary|The Proportion of Responders on Day 29 Who Remained Responders on Days 57, 85, 113, 148 and 183 as Measured by the ILA at Maximum Frown.|"ILA~4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3.~A responder at maximum frown was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at maximum frown at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1). Subjects who were not responders at Day 29 were excluded from the analysis.~The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 57, 85, 113, 148 and 183|mITT: All randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.|||Adjusted percentage of responders||95% Confidence Interval|Number
2584828|NCT02353871|Secondary|The Proportion of Responders at Each Post-treatment Visit to the Study Centre (Except Day 29) as Measured by the ILA at Maximum Frown.|"ILA~4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3.~A responder at maximum frown was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at maximum frown at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1).~The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 8, 15, 57, 85, 113, 148 and 183|mITT: all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. N'=number of subjects with available data at the given visit; P=placebo.|||Adjusted percentage of responders||95% Confidence Interval|Number
2584829|NCT02353871|Primary|The Proportion of Responders at Day 29 in the ILA of Glabellar Lines at Maximum Frown.|"ILA~4-point photographic scale: None - Grade 0; mild - Grade 1; moderate - Grade 2; severe - Grade 3.~A responder at maximum frown was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at maximum frown on Day 29 and a severity grade of moderate (Grade 2) or severe (Grade 3) at Baseline (Day 1).~The adjusted proportion of responders in each treatment group was provided using a multivariate logistic regression model."|Day 29|Modified intent-to-treat (mITT) population included all randomised subjects who received at least one injection of study treatment into one injection site and who had both Baseline and at least one postbaseline value for the ILA of glabellar lines at maximum frown. Subjects who did not have available data at Day 29 were excluded from the analysis.|||Adjusted percentage of responders||95% Confidence Interval|Number
2584830|NCT02353832|Secondary|Spacer Stability by Dimensions|Determine spacer's stability during course of therapy and to ensure that it is stable enough to reliably use for high dose SABR treatments (using cone beam CTs done during each treatments to measure spacer dimensions).|1 month||2020-12-31|12/2020||||
2584831|NCT02353832|Secondary|Spacer Related Acute Toxicity|Assess for spacer related acute toxicity. Spacer related toxicity could be related to the procedure itself (bleeding, infection, pain), or secondary effects of spacer (erectile dysfunction, persistent pain and discomfort).|5 years|||||||
2584832|NCT02353832|Primary|Effectiveness of Space Creation of >= 7.5 mm in Protecting Rectum From Toxicity|The effectiveness of rectal spacer use was measured to determine if they are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects|Median 9 months within the end of radiation treatment||||mm||Full Range|Median
2584833|NCT02353832|Primary|Percentage of Participants With Reduction in Acute Per-prostatic Rectal Ulcer Events Events From 90%+ to <70% (Particularly in the Anterior Rectum)|The effectiveness of rectal spacer use was measured to determine if they are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects|Median 9 months within the end of radiation treatment|Observed ulceration rate|||percentage of participants|||Number
2584838|NCT02353806|Primary|Drug Level/Concentration in Infant Blood (Amlodipine Level/Concentration)|Infant amlodipine level/concentration will be determined.|Infant blood sample drawn at approximately 36 hours of life|Of the 16 patients enrolled in the study, only 8 continued in the study and allowed their infant's to have study sampling performed.|||ng/mL||Standard Deviation|Mean
2584839|NCT02353806|Primary|Amlodipine Concentration in Breastmilk|The concentration of amlodipine besylate was measured in breastmilk samples.|Breast milk samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing||||ng/mL||Standard Deviation|Mean
2584840|NCT02353806|Primary|Drug Levels/Concentration in Cord Blood (Amlodipine Levels/Concentrations)|Maternal and cord blood amlodipine levels/concentrations will be determined.|Pair maternal blood sample and cord blood sample will draw within 1 hour of delivery||||ng/mL||Standard Deviation|Mean
2584841|NCT02353806|Primary|Clearance Rate of Plasma Amlodipine|The clearance rate of amlodipine from the maternal plasma was measured.|Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing|Although 16 women were enrolled in the trial, only 11 had their blood drawn at the time of delivery due to limited availability of study personnel.|||L/hr||Standard Deviation|Mean
2584842|NCT02353806|Primary|Half-life of Amlodipine in Maternal Plasma|The half-life of amlodipine in the maternal plasma in the peripartum period was measured.|Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing||||Hours||Standard Deviation|Mean
2584843|NCT02353806|Primary|Maximal Amlodipine Maternal Serum Concentration|The maximum concentration of amlodipine detected in the maternal serum in the peripartum period was measured.|Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing|Although 16 women were enrolled in the trial, only 11 had their blood drawn at the time of delivery due to limited availability of study personnel.|||ng/mL||Standard Deviation|Mean
2584844|NCT02353806|Primary|Time to Maximal Concentration in the Maternal Serum.|The time to reach maximal amlodipine concentration in the maternal serum in the peripartum period was measured.|Maternal blood samples were obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing|Although 16 women were enrolled in the trial, only 11 had their blood drawn at the time of delivery due to limited availability of study personnel.|||Hours||Standard Deviation|Mean
2584845|NCT02353806|Primary|Area Under the Curve for Amlodipine in the Maternal Serum|The time to peak amlodipine concentration in the maternal serum in the peripartum period was be measured.|Maternal blood samples will be obtained at 4, 6, 8, 12, 15 and 24 hours after amlodipine dosing|Although 16 women were enrolled in the study, only 11 of the 16 had blood drawn at the time of delivery. This was due to limitations of study personnel availability to attend the deliveries of all study patients|||(hr*ng)/mL||Standard Deviation|Mean
2584846|NCT02353754|Secondary|Total Postsurgical Narcotic Consumption in Morphine Equivalents|Outcome measure data refer to 7 participants who received rescue medication|Through 48 hours||||MUEs||Standard Deviation|Mean
2584847|NCT02353754|Secondary|Total Postsurgical Narcotic Consumption in Morphine Equivalents|Outcome measure data refer to 6 participants who received rescue medication|Through 24 hours||||MUEs||Standard Deviation|Mean
2584848|NCT02353754|Primary|Total Postsurgical Narcotic Consumption in Morphine Equivalents|Outcome measure data refer to 7 participants who received rescue medication|Through 72 hours postdose||||MUEs||Standard Deviation|Mean
2584849|NCT02353572|Primary|Maximally Tolerable Dose (MTD) of Both Melphalan and Bortezomib as Combination|MTD is defined as one dose below that which 33% of patients within cohort experienced dose limiting toxicity. Unacceptable toxicity is defined as intractable veno-occlusive disorder, new onset of renal failure requiring dialysis, acute heart failure of New York Heart Association class III/IV, or interstitial pneumonia requiring ventilator management for longer than 3 days or grade 4 neuropathy. A 100-day mortality/toxicity rate of 3% or more is considered unacceptable. Will consider as evidence an observed 100-day mortality/toxicity rate whose lower one-sided 90% confidence bound exceeds 3%.|100 days|The study was terminated, study endpoints were not reached.||||||
2584850|NCT02353468|Primary|Event Free Survival Rates by Land-mark Analysis|A Kaplan-Meier curve would have been used to describe the distribution.|up to 5 years|The study was terminated, study endpoints were not reached.||||||
2584851|NCT02353442|Secondary|Pain and Function at 4weeks (Pre and Post Treatment)|For these measures, the SPADI (Shoulder Pain and Disabilities Index) questionnaire was used, pre and post treatment. The is a self-assessment questionnaire with 5 questions about pain and 8 about functional activities. The final score (0-100) of the questionnaire is provided in percentage and a maximum score of 100 implies the worst possible condition.|4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)||||scores on a scale||Standard Deviation|Mean
2584852|NCT02353442|Secondary|Pressure Pain Threshold at 4weeks (Pre and Post Treatment).|It was measured by a digital algometer in kPa pre and post treatment.|4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)||||kPa||Standard Deviation|Mean
2584853|NCT02353442|Secondary|Strength of the Shoulder External Rotators at 4weeks (Pre and Post Treatment).|The strength was evaluated with digital dynamometer in Newton pre and post treatment.|4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)||||Newton||Standard Deviation|Mean
2584854|NCT02353442|Primary|Humeral Translations at 4weeks (Pre and Post Treatment).|It was assessed in millimeters with 3D system pre and post treatment.|4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)||||Millimeters||Standard Error|Mean
2584855|NCT02353442|Primary|Scapular Kinematics at 4weeks (Pre and Post Treatment)|It was assessed in degrees with 3D system pre and post treatment.|4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)||||degrees||Standard Error|Mean
2584856|NCT02353299|Secondary|Number of Participants With Adverse Events|Adverse events were defined by any negative event experienced by a participant during the study (assessed in the morning prior to participants leaving the lab) and included the washout period following each treatment.|throughout the study until the final study visit, up to 6 weeks||||Participants|||Number
2584857|NCT02353299|Secondary|Delayed Free Recall Task|"Delayed Free Recall Task was performed 15 minutes after final awakening the morning~Free Recall is a basic paradigm in the psychological study of memory. In this paradigm, participants were presented with a total of 16 words serially. They were informed prior to the task that memory for the presented words would be tested later in the session. Participants were asked to recall as many words as they can 15 minutes after final awakening in the morning"|15 minutes after final awakening the morning||||Number of words||Standard Deviation|Mean
2584858|NCT02353299|Secondary|Immediate Free Recall Task|"Immediate Free Recall will be performed at T-max for silenor and matching placebo at 4 hours post dose and at 1.5 hours post dose for zolpidem 10 mg and matching placebo.~Free Recall is a basic paradigm in the psychological study of memory. In this paradigm, participants were presented with a total of 16 words serially. They were informed prior to the task that memory for the presented words would be tested later in the session."|directly after the encoding task||||Number of words||Standard Deviation|Mean
2584859|NCT02353299|Secondary|Berg Balance Test|"Berg Balance will be performed at T-max for silenor and matching placebo at 4 hours post dose and at 1.5 hours post dose for zolpidem 10 mg and matching placebo.~Fall risk as impacted by gait was measured using the Berg Balance Scale (BBS). The BBS is a widely used clinical test of static and dynamic balance abilities. Comprising of 14 simple balance-related tasks, ranging from standing up from a sitting position to standing on one foot, the BBS takes 15-20 minutes to complete. Each component task is scored on a Likert scale: 0 (unable to perform) to 4 (performed independently). The sum of component scores yields the final BBS score (0-20: high fall risk; 21-40: medium fall risk; 41-56: low fall risk)."|at either 1.5 or 4 hours post dose||||sum of component scores||Standard Deviation|Mean
2584860|NCT02353299|Secondary|Tandem Walk Duration Over Five Trials|"Tandem walk will be performed at T-max for Silenor and matching placebo at 4 hours post dose and at 1.5 hours post dose for zolpidem 10 mg and matching placebo.~Fall risk as impacted by balance was measured using the Tandem Walk Test (TWT), which assesses balance via a method of walking in which the toes of the back foot must touch the heel of the front foot at each step; this elicits postural control by reducing the base of support compared to normal walking. Endpoint: mean completion duration over five trials."|at either 1.5 or 4 hours post dose||||Seconds||Standard Deviation|Mean
2584861|NCT02353299|Secondary|Tandem Walk Step-Offs|"Tandem walk will be performed at T-max for Silenor and matching placebo at 4 hours post dose and at 1.5 hours post dose for zolpidem 10 mg and matching placebo.~Fall risk as impacted by balance was measured using the Tandem Walk Test (TWT), which assesses balance via a method of walking in which the toes of the back foot must touch the heel of the front foot at each step; this elicits postural control by reducing the base of support compared to normal walking. Endpoints were the number of step-offs from the beam."|at either 1.5 or 4 hours post dose||||number of step offs||Standard Deviation|Mean
2584862|NCT02353299|Primary|Auditory Arousal Threshold (AAT) at T-max|"AAT will performed at T-max for Silenor and matching placebo at 4 hours post dose. Assessments performed at t max for zolpidem and placebo at 1.5 hours post dose.~An acoustic stimulus (1000 Hz tone) was presented through audiometric earphones (E-A-RTone 3A Insert Earphones). Tones began at 30 dB and increased by 5 dB until the participant woke up or the maximum dB-level (110 dB) was reached."|at either 1.5 or 4 hours post dose||||Decibels (dB)||Standard Deviation|Mean
2584863|NCT02353169|Secondary|Blood Potassium Levels at 15min and 30min Post-intervention|Blood potassium levels at 15 min and 30 min after a bolus of dexmedetomidine or saline. Measured from 1mL venous blood sample with blood gas analyzer|over 30 minutes post-intervention||||mEq/L||Standard Deviation|Mean
2584864|NCT02353169|Secondary|Blood Glucose Levels at 15min and 30min Post-intervention|Blood glucose levels at 15 min and 30 min after a bolus of dexmedetomidine or saline. Measured from 1 mL venous blood sample with blood gas analyzer.|over 30 minutes post-intervention||||mmol/L||Standard Deviation|Mean
2584865|NCT02353169|Primary|Myocardial Repolarization (QTc and TP-e Intervals) 1min After Intervention|Absolute QTc and TP-e values 1min after a bolus of dexmedetomidine or saline. Measured with 12-lead ECG.|60 seconds post-intervention||||ms||Standard Deviation|Mean
2584866|NCT02353091|Other Pre-specified|Screening Instrument For Targeting Educational Risk Performance Scale - Attention Subscale|Raw unstandardised score measured in Likert Scale (5 scales). Minimum score is 1, maximum score is 5. Higher score means better outcome. The three Attention Subscales are averaged to create one combined score.|6 months|"Only 5 questionnaires given to teachers were returned, all from the intervention group. The data for these 5 questionnaires are presented in the APD Group 2, as all 5 cases are from that group only. Group 1 has no data. I left it empty because even if I put 0 I get this Error: Measure Data should not be entered when the Number Analyzed is zero."|||units on a scale||Standard Deviation|Mean
2584867|NCT02353091|Other Pre-specified|The Children's Communication Checklist - 2 - Non-Standard Language Composite Score|Parental questionnaire. Average composite of scaled scores are used to calculate the outcome, so units are scaled scores. Maximum value is 1, maximum value is 19. Higher score means better outcome.|Baseline to 6 months|One parent from intervention group did not complete any of the questionnaires, hence intervention group number analysed was 12.|||scaled scores||Standard Deviation|Mean
2584868|NCT02353091|Other Pre-specified|The Children's Communication Checklist - 2 - Standard Language Composite Score|Parental questionnaire. Average composite of scaled scores are used to calculate the outcome, so units are scaled scores. Maximum value is 1, maximum value is 19. Higher score means better outcome.|6 months|One parent from intervention group did not complete any of the questionnaires, hence intervention group number analysed was 12.|||scaled scores||Standard Deviation|Mean
2584869|NCT02353091|Other Pre-specified|Children's Auditory Performance Scale - Auditory Attention Span Subscale|Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.|Baseline to 6 months||||Units on a scale||Standard Deviation|Mean
2584870|NCT02353091|Other Pre-specified|Children's Auditory Performance Scale - Auditory Memory Sequencing Subscale|Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.|Baseline to 6 months||||Units on a scale||Standard Deviation|Mean
2584871|NCT02353091|Other Pre-specified|Children's Auditory Performance Scale - Multiple Inputs Subscale|Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.|Baseline to 6 months||||Units on a scale||Standard Deviation|Mean
2584872|NCT02353091|Other Pre-specified|Children's Auditory Performance Scale - Noise Subscale|Parental questionnaire measured in raw unstandardised scores. Minimum value is -5, maximum value is +1. Higher score means better outcome.|Baseline to 6 months||||units on a scale||Standard Deviation|Mean
2584873|NCT02353091|Secondary|Test of Everyday Attention for Children TEACh - Divided Auditory Attention Subscale|A validated attention test to test children's auditory attention. Measured on scaled scores. Minimum value 1, maximum value 19. Higher scores mean better outcome.|Baseline to 6 months||||scaled scores||Standard Deviation|Mean
2584874|NCT02353091|Secondary|Test of Everyday Attention for Children TEACh - Selective Visual Attention Subscale|A validated attention test to test children's visual attention. Measured on scaled scores. Minimum value 1, maximum value 19. Higher scores mean better outcome.|Baseline to 6 months||||scaled scores||Standard Deviation|Mean
2584875|NCT02353091|Secondary|Test of Everyday Attention for Children TEACh - Divided Auditory-Visual Attention Subscale|A validated attention test to test children's auditory-visual attention. Measured on scaled scores. Minimum value 1, maximum value 19. Higher scores mean better outcome.|Baseline to 6 months||||scaled scores||Standard Deviation|Mean
2584876|NCT02353091|Secondary|Test of Everyday Attention for Children TEACh - Sustained Auditory Attention Subscale|A validated attention test to test children's auditory attention. Measured on scaled scores. Minimum value 1, maximum value 19. Higher scores mean better outcome.|Baseline to 6 months||||scaled scores||Standard Deviation|Mean
2584877|NCT02353091|Primary|Listening in Spatialised Noise - Sentences Test (LiSN-S) - Total Advantage Condition|Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.|Baseline to 6 months|One outlier in the intervention group was found. Outlier was removed as participant had decreased focus and difficulty remaining seated during this condition.|||z scores||Standard Deviation|Mean
2584878|NCT02353091|Primary|Listening in Spatialised Noise - Sentences Test (LiSN-S) - Spatial Advantage Condition|Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.|Baseline to 6 months||||z scores||Standard Deviation|Mean
2584879|NCT02353091|Primary|Listening in Spatialised Noise - Sentences Test (LiSN-S) - Talker Advantage Condition|Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.|Baseline to 6 months||||z scores||Standard Deviation|Mean
2584880|NCT02353091|Primary|Listening in Spatialised Noise - Sentences Test (LiSN-S) - High-cue Speech Reception Threshold Condition|Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.|6 months|One outlier in the intervention group was found. Outlier was removed as participant had decreased focus and difficulty remaining seated during this condition.|||z scores||Standard Deviation|Mean
2584881|NCT02353091|Primary|Listening in Spatialised Noise - Sentences Test (LiSN-S) - Low-cue Speech Reception Threshold Condition|Speech in noise test measured in z scores. Minimum value -2, maximum value +2. Higher scores mean better outcome. Z scores are automatically calculated in the computer test software based on normative sample data on decibel (dB) measures.|Baseline to 6 months||||z scores||Standard Error|Mean
2584882|NCT02353091|Primary|Listening Inventory For Education Revised (LIFE-R) - Total Score|Children questionnaire measured in raw scores. This is the total score of 9 questions on a likert scale from 0 to 5. Thus, this is the summed score. Therefore, minimum value 0, maximum value 45. Higher scores mean better outcome.|Baseline to 6 months|An outlier at the 3-month time-point (at -3.25 SDs) was removed|||Units on a scale||Standard Deviation|Mean
2584883|NCT02352974|Secondary|Mean IDAA1c Values, Month 43|Insulin dose-adjusted HbA1c (IDAA1c)|Month 43, extension period||||IU/kg/day||Standard Deviation|Mean
2584884|NCT02352974|Secondary|Mean IDAA1c Values, Month 30|Insulin dose-adjusted HbA1c (IDAA1c)|Month 30||||IU/kg/day||Standard Deviation|Mean
2584885|NCT02352974|Secondary|Mean IDAA1c Values, Month 15|Insulin dose-adjusted HbA1c (IDAA1c)|Month 15||||IU/kg/day||Standard Deviation|Mean
2584886|NCT02352974|Secondary|Mean IDAA1c Values, Baseline|Insulin dose-adjusted HbA1c (IDAA1c)|Baseline||||IU/kg/day||Standard Deviation|Mean
2584887|NCT02352974|Secondary|External Insulin Dose, Month 43|External insulin dose at month 43|Month 43, extension period||||IU/kg/day||Standard Deviation|Mean
2584888|NCT02352974|Secondary|External Insulin Dose, Month 30|External insulin dose at month 30|Month 30||||IU/kg/day||Standard Deviation|Mean
2584889|NCT02352974|Secondary|External Insulin Dose, Month 15|External insulin dose at month 15|Month 15||||IU/kg/day||Standard Deviation|Mean
2584890|NCT02352974|Secondary|External Insulin Dose, Baseline|External insulin dose at baseline|Baseline||||IU/kg/day||Standard Deviation|Mean
2584891|NCT02352974|Secondary|Mean Change in HbA1c, Month 43|Change from baseline to month 43 in HbA1c|Baseline to month 43, extension period||||mmol/mol||Standard Deviation|Mean
2584892|NCT02352974|Secondary|Mean Change in HbA1c, Month 30|Change from baseline to month 30 in HbA1c|Baseline to month 30||||mmol/mol||Standard Deviation|Mean
2584893|NCT02352974|Secondary|Mean Change in HbA1c, Month 15|Change from baseline to month 15 in HbA1c|Baseline to month 15||||mmol/mol||Standard Deviation|Mean
2584894|NCT02352974|Secondary|Mean Change in Fasting C-peptide Value, Month 43|Change from baseline to month 43 in fasting C-peptide value|Baseline to month 43, extension period||||nmol/L||Standard Deviation|Mean
2584895|NCT02352974|Secondary|Mean Change in Fasting C-peptide Value, Month 30|Change from baseline to month 30 in fasting C-peptide value|Baseline to month 30||||nmol/L||Standard Deviation|Mean
2584896|NCT02352974|Secondary|Mean Change in Fasting C-peptide Value, Month 15|Change from baseline to month 15 in fasting C-peptide value|Baseline to month 15||||nmol/L||Standard Deviation|Mean
2584897|NCT02352974|Secondary|Mean Change in C-peptide 90-minute Value, Month 43|Change from baseline to month 43 in C-peptide 90-minute value|Baseline to month 43, extension period||||nmol/L||Standard Deviation|Mean
2584898|NCT02352974|Secondary|Mean Change in C-peptide 90-minute Value, Month 30|Change from baseline to month 30 in C-peptide 90-minute value|Baseline to month 30||||nmol/L||Standard Deviation|Mean
2584899|NCT02352974|Secondary|Mean Change in C-peptide 90-minute Value, Month 15|Change from baseline to month 15 in C-peptide 90-minute value|Baseline to month 15||||nmol/L||Standard Deviation|Mean
2584985|NCT02351167|Secondary|Initial Cessation|Defined as at least 1 day of abstinence during the first 7 days after the target quit day.|Assessed for the first seven days after the target quit date||||Participants|||Count of Participants
2584900|NCT02352974|Secondary|Mean Change in C-peptide AUC(Mean 120min) Value, Month 43|"Change from baseline to month 43 in C-peptide AUC(mean 120min) value~AUC (mean 120min) (nmol/L) is the C-peptide AUC during an MMTT (nmol/L*minutes) divided by the duration of the MMTT (minutes) i.e. C-peptide weighted average concentration"|Baseline to month 43, extension period at 0, 30, 60, 90, 120 minutes post-dose||||nmol/L||Standard Deviation|Mean
2584901|NCT02352974|Secondary|Mean Change in C-peptide AUC(Mean 120min) Value, Month 30|"Change from baseline to month 30 in C-peptide AUC(mean 120min) value~AUC (mean 120min) (nmol/L) is the C-peptide AUC during an MMTT (nmol/L*minutes) divided by the duration of the MMTT (minutes) i.e. C-peptide weighted average concentration"|Baseline to month 30 at 0, 30, 60, 90, 120 minutes post-dose||||nmol/L||Standard Deviation|Mean
2584902|NCT02352974|Secondary|Mean Change in C-peptide AUC (Area Under the Curve) (Mean 120min) Value, Month 15|"Change from baseline to month 15 in C-peptide AUC (Area Under the Curve) (mean 120min) value~AUC (mean 120min) (nmol/L) is the C-peptide AUC during an MMTT (nmol/L*minutes) divided by the duration of the MMTT (minutes) i.e. C-peptide weighted average concentration"|Baseline to month 15 at 0, 30, 60, 90, 120 minutes post-dose||||nmol/L||Standard Deviation|Mean
2584903|NCT02352974|Primary|Number of Subjects With Injection Site Reactions Month 32|Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching)|Month 32, extension period||||Participants|||Count of Participants
2584904|NCT02352974|Primary|Number of Subjects With Injection Site Reactions Month 3|Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching)|Month 3||||Participants|||Count of Participants
2584905|NCT02352974|Primary|Number of Subjects With Injection Site Reactions Month 2|Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching)|Month 2||||Participants|||Count of Participants
2584906|NCT02352974|Primary|Number of Subjects With Injection Site Reactions Month 1|Reactions of the injection site (Erythema, Oedema, Haematoma, Tenderness, Pain, Itching)|Month 1||||Participants|||Count of Participants
2584907|NCT02352948|Secondary|Time From Randomisation to Second Progression (PFS2) of Sub-study B|The PFS2 was defined as the time from the date of randomization to the earliest of the progression event subsequent to that used for the PFS endpoint or death and determined by local standard clinical practice and have included any of the following: objective radiological, symptomatic progression, or death. PFS2 was reported for sub-study B only.|Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until first progression. Disease then assessed per local practice until 2nd progression. Assessed up to a maximum of approximately 3 years.|FAS included all randomized participants analyzed on an ITT basis.|||months||95% Confidence Interval|Median
2584908|NCT02352948|Secondary|Percentage of Participants Alive and Progression Free at 12 Months (APF12)|The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 at 12 months after randomization per Kaplan-Meier estimate of PFS at 12 months. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion|Tumour scans performed at baseline then every ~8 weeks up to 12 months.|Sub-study A and B: FAS included all randomized participants analyzed on an ITT basis.|||percentage of participants||95% Confidence Interval|Number
2584909|NCT02352948|Secondary|Percentage of Participants Alive and Progression Free at 6 Months (APF6)|The APF6 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 at 6 months after randomization per Kaplan-Meier estimate of PFS at 6 months. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion|Tumour scans performed at baseline then every ~8 weeks up to 6 months|Sub-study A and B: FAS included all randomized participants analyzed on an ITT basis.|||percentage of participants||95% Confidence Interval|Number
2584910|NCT02352948|Secondary|Duration of Response (DoR)|The DoR was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The DoR was determined by Investigator assessments according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion|Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.|Sub-study A and B: FAS included all randomized participants with measureable disease at baseline analyzed on an ITT basis. Only participants with objective response were analyzed.|||months||Inter-Quartile Range|Median
2584911|NCT02352948|Secondary|Objective Response Rate (ORR)|The ORR was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR) among ITT participants who had measurable disease at baseline. CR was defined as disappearance of all target lesions (any pathological lymph nodes selected as target lesions must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum of diameters as long as criteria for PD are not met). The ORR was measured using Investigator assessments according to RECIST v1.1.|Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.|Sub-study A and B: FAS included all randomized participants with measureable disease at baseline analyzed on an ITT basis.|||percentage of participants|||Number
2584912|NCT02352948|Secondary|PFS, Contribution of the Components Analysis of Sub-study B|The PFS was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression. The PFS was determined by Investigator assessments according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion|Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.|FAS included all randomized participants analyzed on an ITT basis.|||months||95% Confidence Interval|Median
2585198|NCT02348203|Secondary|Change in the Three Lung Cancer Gene Signatures of Nasal Epithelium||Baseline to 14 days post intervention|||||||
2584913|NCT02352948|Secondary|Percentage of Participants Alive at 12 Months (OS12)|The OS12 was defined as the percentage of participants who were alive at 12 months after randomisation per Kaplan-Meier estimate of OS at 12 months.|From randomization (Day 1) up to 12 months|Sub-study A and B: FAS included all randomized participants analyzed on an ITT basis.|||percentage of participants||95% Confidence Interval|Number
2584914|NCT02352948|Secondary|OS, Contribution of the Components Analysis of Sub-study B|The OS was defined as the time from the date of randomization until death due to any cause.|From randomization (Day 1) until death due to any cause, approximately 36 months|FAS included all randomized participants analyzed on an ITT basis.|||months||95% Confidence Interval|Median
2584915|NCT02352948|Primary|Progression-Free Survival (PFS)|The PFS was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression. The PFS was determined by Investigator assessments according to response evaluation criteria in solid tumours (RECIST) version 1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion|Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.|Sub-study A and B: FAS included all randomized participants analyzed on an ITT basis.|||months||95% Confidence Interval|Median
2584916|NCT02352948|Primary|Overall Survival (OS)|The OS was defined as the time from the date of randomization until death due to any cause.|From randomization (Day 1) until death due to any cause, approximately 36 months|Sub-study A and B: FAS included all randomized participants analyzed on an ITT basis.|||months||95% Confidence Interval|Median
2584917|NCT02352844|Secondary|Genetic Changes Associated With Disease Progression|-To investigate the genetic changes associated with disease progression following treatment with everolimus.|Completion of treatment (estimated average of 6 months)|"Out of the 8 participants evaluable for response, only 6 were evaluable for this outcome measure because only 6 participants had disease progression~Please note that 1 participant had both NF1 c.7190C>T and NF1 c.7253C>T mutations in the sample"|||Participants|||Count of Participants
2584918|NCT02352844|Secondary|Mutations Associated With Therapeutic Response|-To correlate mutations in the mTOR pathway with therapeutic response with everolimus|Completion of treatment (estimated average of 6 months)|4 participants were not evaluable for this outcome measure as they discontinued treatment prior to disease assessment and are not evaluable for this outcome measure. Out of the 8 remaining participants, only one participant had a response (complete response to therapy) and specific mutations associated with response are described below.|||Participants|||Count of Participants
2584919|NCT02352844|Primary|Response Rate (RR)|The primary endpoint will be to describe the response rate using RECIST 1.1. Response rate will be defined as complete response (disappearance of all target lesion) plus partial response (a least a 30% decrease in the sum of diameters of target lesions).|Completion of treatment (estimated average of 6 months)|4 participants were not evaluable for this outcome measure as they discontinued treatment prior to disease assessment.|||Participants|||Count of Participants
2584920|NCT02352831|Secondary|Number of Participants With a CA19-9 Response|"CA19-9 is a tumor marker that is used in the management of pancreatic cancer. Rising CA19-9 levels may mean the tumor is growing and decreasing CA19-9 levels may mean the tumor is shrinking or the amount of cancer in the body is decreasing~A CA19-9 response means that the tumor marker has decreased over baseline (before treatment started) levels"|Completion of treatment (median treatment length 81.50 days (28.00-346.00)||||Participants|||Count of Participants
2584921|NCT02352831|Secondary|Overall Survival Rate (OS)||Up to 1 year from completion of treatment (median treatment length 81.50 days (28.00-346.00)||||Participants|||Count of Participants
2584922|NCT02352831|Secondary|Time-to-progression (TTP)|"-Progressive disease (PD)~Target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).~Non target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase"|Up to 24 months||||days||Full Range|Median
2584923|NCT02352831|Secondary|Overall Response Rate (ORR)|"ORR = Complete response + partial response~Target lesions~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Non target lesions *Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis)."|Up to 18 months||||Participants|||Count of Participants
2584924|NCT02352831|Primary|Progression-free Survival (PFS) Rate|"PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.~Progressive disease (PD)~Target lesions: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).~Non target lesions: Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase."|3 months||||Participants|||Count of Participants
2584936|NCT02352493|Secondary|Pharmacodynamic (PD) Effect of ALN-CC5: Percentage Reduction From Baseline in Complement Alternative Pathway (CAP)|Complement activity was measured in serum samples collected at timepoints throughout the study using the CAP ELISA assay. Percentage reduction was calculated relative to baseline levels. A positive value indicates a reduction in CAP from baseline.|Part A: through day 70; Part B: through day 140; Part C: through day 140||||percentage reduction||Standard Error|Mean
2585199|NCT02348203|Secondary|Change in the Smoking-related Gene Expression Signature||Baseline to 14 days post intervention|||||||
2584925|NCT02352831|Primary|Phase I Only: Number of Participants Who Experience Dose-limiting Toxicities (DLTs)|"Possibly/probably/definitely related to study treatment in 1st cycle (cyc)~*Grade (Gr) 4 neutropenia >7 day, Febrile neutropenia of any duration with temperature ≥ 38.5 °C, Gr 4 anemia requires transfusion therapy on more than 2 occasions in 7 days, Gr 4 thrombocytopenia~Possibly/probably/definitely related gr. 3/4 non-hematologic toxicity that occurs 1st cyc with the following EXCEPTIONS:~Gr 3 nausea/vomiting/diarrhea/anorexia <72 hours that returns to Gr 1 prior to the start of cyc 2, Gr 3 hand-foot syndrome will only be considered a DLT for patients who have received 1 week of supportive care treatment with no improvement, Gr 3 fatigue that returns to Gr 1 prior to the start of cyc 2, Gr 3 flu-like symptoms <72 hours that returns to Gr 1 prior to start of cyc 2, Gr 3 arthralgia or myalgias <72 hours that return to Gr 1 prior to the start of cyc 2, Gr 3 potassium/phosphorus/magnesium that is asymptomatic or of non-clinical significance <72 hours, Gr 3 hypoalbuminemia"|Completion of cycle 1 of all participants in Phase I portion of study (approximately 14 months)|This outcome measure is for Phase I participants only.|||Participants|||Count of Participants
2584926|NCT02352831|Primary|Phase I Only: Recommended Phase II Dose of Tosedostat|"The recommended phase 2 dose (RP2D) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. If 0 or 1 of 6 patients in Dose Level 1 experience DLT during the first cycle, Dose Level 1 will be presumed to be the RP2D.~DLTs are followed through completion of the first cycle."|Completion of cycle 1 of all participants in Phase I portion of study (approximately 14 months)|This outcome measure is for Phase I participants only.|||mg daily|||Number
2584927|NCT02352779|Primary|Mean Change (6 Weeks - Baseline) and Standard Deviation in Cancer-related Fatigue, Using the Brief Fatigue Inventory-Short Form (BFI-SF) and Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF). 81 Subjects Had Both a Baseline and 6 Week Value|"BFI-SF is a 4 item questionnaire to assess the severity of fatigue, ranging from 0 (No Fatigue) to 10 (As bad as you can imagine).~MFSI-SF is a 30 item questionnaire to assess the level of fatigue in terms of general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor). First four subscales (general, physical, emotional, and mental) are summed and the vigor scale is subtracted to create fatigue total score with a range of -32 (low fatigue) to 96 (high fatigue)."|Baseline to 6 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2584928|NCT02352493|Secondary|Pharmacokinetic (PK) Effect of ALN-CC5: AUC 0-t (23-mer)|Area under the plasma concentration-time curve over the dosing interval zero to time (AUC 0-t) of ALN-CC5 (cemdisiran) 23-mer.|Part A: 0-48 hrs, Day 0; Part B (weekly dosing cohorts): 0-48 hrs, Day 28; Part B (biweekly, weekly/monthly/biweekly/monthly cohorts): 0-48 hrs, Day 84; Part C: 0- 24 hrs, Day 84|All healthy volunteers/patients who received at least one dose of study drug, and who had evaluable plasma or urine PK concentration. For the ALN-CC5 Multiple Dose - Eculizumab Naive group, Day 84 plasma samples were not collected.|||h*ng/mL||Standard Deviation|Mean
2584929|NCT02352493|Secondary|Pharmacokinetic (PK) Effect of ALN-CC5: AUC 0-t (25-mer)|Area under the plasma concentration-time curve over the dosing interval zero to time (AUC 0-t) of ALN-CC5 (cemdisiran) 25-mer.|Part A: 0-48 hrs, Day 0; Part B (weekly dosing cohorts): 0-48 hrs, Day 28; Part B (biweekly, weekly/monthly/biweekly/monthly cohorts): 0-48 hrs, Day 84; Part C: 0- 24 hrs, Day 84|All healthy volunteers/patients who received at least one dose of study drug, and who had evaluable plasma or urine PK concentration. For the ALN-CC5 Multiple Dose - Eculizumab Naive group, Day 84 plasma samples were not collected.|||h*ng/mL||Standard Deviation|Mean
2584930|NCT02352493|Secondary|Pharmacokinetic (PK) Effect of ALN-CC5: T Max (23-mer)|Time of maximum observed plasma concentration (T max) of ALN-CC5 (cemdisiran) 23-mer.|Part A: 0-48 hrs, Day 0; Part B (weekly dosing cohorts): 0-48 hrs, Day 28; Part B (biweekly, weekly/monthly/biweekly/monthly cohorts): 0-48 hrs, Day 84; Part C: 0- 24 hrs, Day 84|All healthy volunteers/patients who received at least one dose of study drug, and who had evaluable plasma or urine PK concentration. For the ALN-CC5 Multiple Dose - Eculizumab Naive group, Day 84 plasma samples were not collected.|||hr||Full Range|Median
2584931|NCT02352493|Secondary|Pharmacokinetic (PK) Effect of ALN-CC5: T Max (25-mer)|Time of maximum observed plasma concentration (T max) of ALN-CC5 (cemdisiran) 25-mer.|Part A: 0-48 hrs, Day 0; Part B (weekly dosing cohorts): 0-48 hrs, Day 28; Part B (biweekly, weekly/monthly/biweekly/monthly cohorts): 0-48 hrs, Day 84; Part C: 0- 24 hrs, Day 84|All healthy volunteers/patients who received at least one dose of study drug, and who had evaluable plasma or urine PK concentration. For the ALN-CC5 Multiple Dose - Eculizumab Naive group, Day 84 plasma samples were not collected.|||hr||Full Range|Median
2584932|NCT02352493|Secondary|Pharmacokinetic (PK) Effect of ALN-CC5: Cmax (23-mer)|Maximum observed plasma concentration (Cmax) of ALN-CC5 (cemdisiran) 23-mer.|Part A: 0-48 hrs, Day 0; Part B (weekly dosing cohorts): 0-48 hrs, Day 28; Part B (biweekly, weekly/monthly/biweekly/monthly cohorts): 0-48 hrs, Day 84; Part C: 0- 24 hrs, Day 84|All healthy volunteers/patients who received at least one dose of study drug, and who had evaluable plasma or urine PK concentration. For the ALN-CC5 Multiple Dose - Eculizumab Naive group, Day 84 plasma samples were not collected.|||ng/mL||Standard Deviation|Mean
2584933|NCT02352493|Secondary|Pharmacokinetic (PK) Effect of ALN-CC5: Cmax (25-mer)|Maximum observed plasma concentration (Cmax) of ALN-CC5 (cemdisiran) 25-mer.|Part A: 0-48 hrs, Day 0; Part B (weekly dosing cohorts): 0-48 hrs, Day 28; Part B (biweekly, weekly/monthly/biweekly/monthly cohorts): 0-48 hrs, Day 84; Part C: 0- 24 hrs, Day 84|All healthy volunteers/patients who received at least one dose of study drug, and who had evaluable plasma or urine PK concentration. For the ALN-CC5 Multiple Dose - Eculizumab Naive group, Day 84 plasma samples were not collected.|||ng/mL||Standard Deviation|Mean
2584934|NCT02352493|Secondary|Pharmacodynamic (PD) Effect of ALN-CC5: Percentage Reduction From Baseline in C5 Protein Levels|Total C5 protein levels were measured in serum samples collected at time points throughout the study using a mass spectrometry-based method. Percentage reduction was calculated relative to baseline levels. A positive value indicates a reduction in C5 protein level from baseline.|Part A: through day 70; Part B: through day 140; Part C: through day 140||||percentage reduction||Standard Error|Mean
2584935|NCT02352493|Secondary|Pharmacodynamic (PD) Effect of ALN-CC5: Percentage Reduction From Baseline in Complement Classical Pathway (CCP)|Complement activity was measured in serum samples collected at time points throughout the study using the CCP ELISA assay. Percentage reduction was calculated relative to baseline levels. A positive value indicates a reduction in CCP from baseline.|Part A: through day 70; Part B: through day 140; Part C: through day 140||||percentage reduction||Standard Error|Mean
2584937|NCT02352493|Primary|Number of Participants With Adverse Events|Adverse events were reported for single-ascending doses (SAD) or multiple ascending doses (MAD) of ALN-CC5 when administered to healthy adult subjects and of multiple doses (MD) in patients with paroxysmal nocturnal hemoglobinuria (PNH)|Part A: through day 658; Part B: through day 532; Part C: through day 280||||Participants|||Count of Participants
2584938|NCT02352363|Secondary|Diffusion Capacity of the Lungs for Carbon Monoxide (DLco).|To describe the effects of CVT-301 on diffusion capacity of the lungs for carbon monoxide (DLco) over a 12-month period.|Month 12 reported||||mL/min/mmHg||Standard Deviation|Mean
2584939|NCT02352363|Primary|Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second / Forced Vital Capacity Ratio.|To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second / forced vital capacity ratio).|Month 12 reported||||Ratio (%)||Standard Deviation|Mean
2584940|NCT02352363|Primary|Pulmonary Safety Assessed by Forced Vital Capacity [FVC].|To characterize the pulmonary safety, as assessed by spirometry (forced vital capacity).|Month 12 reported||||Liters||Standard Deviation|Mean
2584941|NCT02352363|Primary|Pulmonary Safety Assessed by Forced Expiratory Volume in 1 Second [FEV1]|To characterize the pulmonary safety, as assessed by spirometry (forced expiratory volume in 1 second [FEV1], over a 12 month period.|Month 12 reported||||Liters||Standard Deviation|Mean
2584942|NCT02352298|Primary|Dario Blood Glucose Monitoring System Accuracy at High Altitude (ISO 15197:2003)|Accuracy of Dario Blood Glucose Monitoring System when compared to Yellow Springs Instrument 2300 reference method at 10,152 feet above sea level. Acceptance criteria set per (International Organization for Standardization) ISO 15197:2003. Greater than or equal to 95% of the Dario results shall fall within plus or minus 15 mg/dL of the reference method value (for glucose concentrations <75 mg/dL). For glucose concentrations greater than or equal to 75 mg/dL, the Dario results shall fall within plus or minus 20% of the reference method value.|6 seconds||||percentage of participants|||Number
2584943|NCT02352103|Other Pre-specified|Post-operative Urinary Function and Urinary Function-related Quality of Life|MSKCC (Memorial Sloan Kettering Cancer Center) STAR questionnaire (symptom tracking and reporting). Score ranges from 0-25, with higher scores indicating better urinary function|1 year median follow up|The numbers in this analyses are different from the primary analyses as some patients were lost to follow up (by one year)|||score on a scale||Inter-Quartile Range|Median
2584944|NCT02352103|Other Pre-specified|Number of Patients Who Regained Urinary Continence Postoperatively|0 pad per day|1 year median follow up||||Participants|||Count of Participants
2584945|NCT02352103|Secondary|Post-operative Urinary Function and Urinary Function-related Quality of Life|International Prostatic Symptom Score (continuous score from 0-35, higher scores indicating worse urinary function)|Within 3 months from the intervention||||score on a scale||95% Confidence Interval|Mean
2584946|NCT02352103|Secondary|Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml)|Patients without biochemical evidence of disease recurrence (i.e. postop PSA >=0.2 ng/mL)|1-year median follow up||||Participants|||Count of Participants
2584947|NCT02352103|Secondary|Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater)|SHIM ranges from 0-25 with higher scores indicating better sexual function; a score of >=22 is normal and >=17 is considered mild ED|1-year median follow up||||Participants|||Count of Participants
2584948|NCT02352103|Secondary|Number of Participants With Peri and Postoperative Complications|Clavien-Dindo complications|1-year median follow up||||Participants|||Count of Participants
2584949|NCT02352103|Secondary|Number of Participants With Urinary Continence Recovery|0 pad per day|within 3 months from the intervention||||participants|||Number
2584950|NCT02352103|Primary|Urinary Continence Recovery|24-hour pad weights|One week after the removal of the suprapubic urinary catheter||||grams||Inter-Quartile Range|Median
2584951|NCT02351960|Secondary|Percentage of Participants in the EE Group Who Had Endoscopically Evaluated Macroscopic Healing of Their Esophagus|Participants underwent endoscopy to determine the percentage of participants with macroscopic healing of their esophagus showing at least 1 Los Angeles (LA) grade classification grade improvement at week 8. Endoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference.|Week 8|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable.|||percentage of participants|||Number
2584952|NCT02351960|Secondary|Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms|The severity of participants' GERD symptoms based on the investigator's assessment among all participants was evaluated at Week 4 or Week 8. GERD symptoms were assessed on a 5-point scale, wherein 1=no symptom, 2=mild, 3=moderate, 4=severe and 5=very severe. GERD symptoms include heartburn (HB), acid regurgitation (AR), dysphagia (dysp), belching (bch) and epigastric pain (EP).|Up to 4 weeks for NERD participants and up to 8 weeks for EE participants|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here, 'n' is the number of participants who were analyzed for GERD assessments at specified time points.|||participants|||Number
2584953|NCT02351960|Secondary|Percentage of Nights (Participant Sleep Time) Without Nighttime Acid Regurgitation|Participants were asked to keep a daily paper diary. The percentage of nights without nighttime acid regurgitation in both the group was assessed by participant diary entries.|Up to 4 weeks for NERD participants and up to 8 weeks for EE participants|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.|||percentage of nights||Full Range|Median
2584969|NCT02351505|Secondary|Tolerability of the Regimen Assessed Through Number of Patients Who Required Dose Modifications and/or Dose Delays||Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study||||||
2584970|NCT02351505|Secondary|Incidence of Severe (Grade 3+) Adverse Events or Toxicities as Per NCI CTCAE v4.0|The incidence of severe (grade 3+) adverse events or toxicities will be described.|Up to 4 years||||percentage of patients|||Number
2584954|NCT02351960|Secondary|Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn|Participants were asked to keep a daily paper diary. The percentage of nights without nighttime heartburn in both the group was assessed by participant diary entries.|Up to 4 weeks for NERD participants and up to 8 weeks for EE participants|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.|||percentage of nights||Full Range|Median
2584955|NCT02351960|Secondary|Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn and Acid Regurgitation|Participants were asked to keep a daily paper diary. The percentage of nights without nighttime heartburn and acid regurgitation in both the group was assessed by participant dairy entries.|Up to 4 weeks for NERD participants and up to 8 weeks for EE participants|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.|||percentage of nights||Full Range|Median
2584956|NCT02351960|Secondary|Percentage of 24-hour Acid Regurgitation-free Days|Participants were asked to keep a daily paper diary. The percentage of 24-hour acid regurgitation-free days following study drug treatments was assessed by participant's diary entries.|Up to 4 weeks for NERD participants and up to 8 weeks for EE participants|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.|||percentage of days||Full Range|Median
2584957|NCT02351960|Secondary|Percentage of 24-hour Heartburn-free Days|Participants were asked to keep a daily paper diary. The percentage of 24-hour heartburn free days following study drug treatments was assessed by the participant diary entries.|Up to 4 weeks for NERD participants and up to 8 weeks for EE participants|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.|||percentage of days||Full Range|Median
2584958|NCT02351960|Primary|Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Erosive Esophagitis (EE) Participants|EE participants were asked to keep a paper diary of daily heartburn and acid regurgitation-free days and the percentage of heartburn and acid regurgitation-free days was calculated.|Up to Week 8|FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.|||percentage of days||Full Range|Median
2584959|NCT02351960|Primary|Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Non-Erosive Reflux Disease (NERD) Participants|NERD participants were asked to keep a paper diary of daily heartburn and acid regurgitation-free days and the percentage of heartburn and acid regurgitation-free days was recorded.|Up to Week 4|Full analysis set (FAS) included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable.|||percentage of days||Full Range|Median
2584960|NCT02351934|Secondary|Number of Participants With Hypokalemia|Hypokalemia is generally defined as a serum potassium level of less than 3.5 mmol/L.|Up to 7 days|Intention to treat analysis|||Participants|||Count of Participants
2584961|NCT02351934|Secondary|Number of Participants With Acute Kidney Injury|Acute kidney injury (AKI) refers to an abrupt decrease in kidney function, resulting in the retention of urea and other nitrogenous waste products and in the dysregulation of extracellular volume and electrolytes. The term AKI has largely replaced acute renal failure (ARF), reflecting the recognition that smaller decrements in kidney function that do not result in overt organ failure are of substantial clinical relevance and are associated with increased morbidity and mortality. The AKI experienced by these patients was not considered an adverse event.|Up to 7 days|Intention to treat analysis|||Participants|||Count of Participants
2584962|NCT02351934|Secondary|Time to Stool Output||Up to 4 days|Intention to treat analysis|||hours||Inter-Quartile Range|Median
2584963|NCT02351934|Secondary|Number of Participants Requiring Nasogastric Tube Placement||Up to 7 days|Intention to Treat Analysis|||Participants|||Count of Participants
2584964|NCT02351934|Secondary|Number of Participants Readmitted to Mayo Clinic Within 30-days||Within 30 days of release from hospital|Intention to treat analysis|||Participants|||Count of Participants
2584965|NCT02351934|Primary|Length of Hospital Stay|Participants will be followed for the duration of hospital stay, an expected average of 2-7 days.|Up to 7 days|Intent to treat analysis|||hours||Inter-Quartile Range|Median
2584966|NCT02351817|Primary|Product Acceptance|"Product acceptance was measurement qualitatively by interviews exploring the factors and mechanisms affecting the acceptance. The interview questions were formulated in such a way that was not possible to quantify the number of subjects accepting the test products.~There were problems with test product performance and handling and therefore the acceptance of the products was not high. Product preference was secondary endpoint, where the subjects were asked whether they preffered their own product over the test products. This endpoint is the best measure we have for mimiking product acceptance. However, we are aware subjects could accept a product without preferring it over own product and the preferrence result might therefore not be accurate.~The result presented below shows how many subjects preferred Test A/Test B over own product"|7 days per test period|One subject did not answer the preference question.|||participants|||Number
2584967|NCT02351739|Primary|Number of Participants With Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Every 12 weeks for up to 2 years.|"The study participants had to have a minimum of one scan (for tumor assessment) after randomization/treatment in order to be considered analyzed.~And some of the participants didn’t make it to Wk 7 of treatment, hence reduction in the number of subjects analyzed."|||Participants|||Count of Participants
2584968|NCT02351505|Secondary|Proportion of Patients Who go Off Treatment Due to Adverse Reactions or Even Those Who Refuse Further Treatment for Lesser Toxicities That Inhibit Their Willingness to Continue Participation on the Trial||Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study||||||
2584971|NCT02351505|Secondary|Frequency of Adverse Events Defined as Adverse Events That Are Classified as Either Not Related, Possibly, Probably, or Definitely Related to Study Treatment as Per NCI CTCAE v4.0|"Summarized by descriptive statistics for each of the disease cohorts. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing."|Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study||||||
2584972|NCT02351505|Secondary|Overall Survival|Kaplan-Meier curves will be used to estimate overall survival. Consider Cox proportional hazards models to explore a limited set of confounding factors.|Date of study registration to the date of event (i.e., death) or the date of last follow-up if no event has occurred at their last evaluation assessed up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study||||||
2584973|NCT02351505|Secondary|Disease Control Rate (CR, PR, and Stable Disease)|Estimates will be accompanied by exact binomial confidence intervals.|Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study||||||
2584974|NCT02351505|Secondary|Objective Response Rate (Complete Response [CR] or Partial Response [PR]) by RECIST|The overall response rate will be calculated as the number of PRs and CRs divided by the total number of evaluable patients. Estimates will be accompanied by exact binomial confidence intervals as well.|Up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study||||||
2584975|NCT02351505|Primary|Progression Free Survival|Estimated by the method of Kaplan and Meier for each cohort. Appropriate one-sided 90% confidence boundary will also be calculated for the final test Kaplan-Meyer test statistic at 12 weeks.|Time from the date of study registration to the date of disease progression or to the date of last observation when no event (disease progression) has occurred, assessed up to 4 years|Unable to analyze data due to only 1 patient being enrolled on the study||||||
2584976|NCT02351271|Other Pre-specified|Number of Participants With Reported Complications|Safety will be assessed by evaluating observed and/or reported device and non-device related Adverse Events and/or Adverse Device Effects between treatment intervention groups A and B. No serious adverse events were reported. One AE in the femto group and two in the manual group were reported.|during follow-up after 1 and 12 days, 4, 8 and 12 weeks||||Participants|||Count of Participants
2584977|NCT02351271|Secondary|Number of Participants With Complete Treatment Pattern|"Completeness of capsulotomy is a subjective metric given by the surgeon. Measurements were scaled into the following four categories: 1: complete treatment pattern; 2: micro-adhesion; 3: incomplete treatment pattern; 4: complete pattern but not continuous. Complete treatment pattern is considered the best result, micro adhesion indicates a minor but manageable problem, incomplete treatment pattern indicates a treatable, but more complex suboptimal outcome and complete treatment but discontinuous pattern indicates the treatable but suboptimal outcome."|during surgery|In all cases, the capsulotomy was categorized as a complete treatment pattern|||Participants|||Count of Participants
2584978|NCT02351271|Secondary|Ease of Phacoemulsification|Ease of phacoemulsification was performed as a subjective observation by the surgeon. Four classifications were possible: easy - phacoemulsification was fast and uncomplicated; 'slight resistance' - phacoemulsification encountered some difficulty; 'resistance noted' - phacoemulsification was somewhat complex; 'difficult' - phacoemulsification was difficult and complex to complete.|during surgery|Participants were classified as 'easy' or as 'slight resistance' in terms of ease of phacoemulsification.|||Participants|||Count of Participants
2584979|NCT02351271|Primary|Effective Phaco Time (EPT)|"Effective Phacoemulsification Time (EPT): EPT for eyes receiving Intervention A being statistically same or lower than EPT for eyes receiving Intervention B at p<0.05 will be considered positive for superior efficacy of application of FEMTO LDV Z8 over the manual procedure~Effective Phaco Time is a unit. It is commonly understood in the area of cataract surgery to be the standard way to describe phaco energy during a procedure over different manufactured phaco devices.~Effective phaco time is the total phaco time at 100 percent phaco power. It can be less than the total foot-pedal time. Less EPT indicates proportionately less energy delivered to the eye thereby reducing the side effects of phaco power."|day of surgery|effective phaco time|||EPT||Standard Deviation|Mean
2584980|NCT02351167|Secondary|Withdrawal|"Withdrawal severity is assessed by Wisconsin Smoking Withdrawal Scale (WSWS), there are 28 items.~Participants rate each item on a scale of 0-4 (0=Strongly disagree, 1=Disagree, 2=Feel neutral, 3=Agree, 4=Strongly agree). The subscale to each item is determined on how high they agree on the scale. For some items, the subscale is determined on how low they agreed. Each score is determined by the mean of each item that applies. Higher means indicate greater withdrawal.~The scores were calculated by averaging a mean score of each item for each participant with data from time point pre-quit, quit, week 1, week 2, and week 4. The mean score for each participant was averaged for each item and a mean score was taken for each treatment condition (cNRT, Varenicline, Placebo). These data are reported as mean withdrawal scores and not change in withdrawal scores."|Pre-quit, quit, week 1, week 2, and week 4|Not all participants were evaluable for this outcome measure due to data not being available.|||score on a scale||Standard Deviation|Mean
2584981|NCT02351167|Secondary|Side Effects|All reported side effects (occurring>4%) will be summarized and presented for the study. In addition, the investigators will further identify a pre-specified set of key side effects as being related to drug agonist effects (e.g., nausea, vomiting, racing heart, headache, and sleep disturbance). These will be analyzed as rate of occurrence during the period of medication use.|Pre-quit week to Week 12|Not all participants were evaluable for this outcome measure due to data not being available.|||Participants|||Count of Participants
2584982|NCT02351167|Secondary|Medication Adherence|Adherence is the proportion of expected medication (varenicline, patch, lozenge) taken as advised during pre-quit week to week 12|Pre-quit week to Week 12|Not all participants were evaluable for this outcome measure due to data not being available. Also the Varenicline (Chantix) and Counseling Arm did not receive the lozenge or the patch. The Combination NRT and Counseling Arm did not receive Varenicline (Chantix)|||proportion of expected medication taken||Standard Deviation|Mean
2584983|NCT02351167|Secondary|Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points.|The definition of this measure requires self-reported cigarettes per day.|0-52 Weeks||2020-08-31|08/2020||||
2584986|NCT02351167|Secondary|Number of Days to Lapse and Relapse|The number of days to lapse is defined as the number of days from the target quit date until the participant reports smoking (even a single puff). The number of days to relapse is defined as the number of days from the target quit day until the first of seven consecutive days of smoking.|Assessed from the target quit day through 52 weeks||2020-08-31|08/2020||||
2584987|NCT02351167|Secondary|7-day Point Prevalence Quit Rate|The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence.|Week 24||||Participants|||Count of Participants
2584988|NCT02351167|Secondary|Continuous Abstinence|The definition of this measure requires: Not taking even 1 cigarette puff from target quit date to end of treatment.|12 weeks (with first 1 week initial grace period)||||Participants|||Count of Participants
2584989|NCT02351167|Primary|7-day Point Prevalence Quit Rate|The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence.|Week 12||||Participants|||Count of Participants
2584990|NCT02351063|Primary|Change in BNP|After a short lead-in period, an algorithm (similar in concept to a moving average) will be applied to the BNP data resulting in a BNP-based parameter. The primary endpoint of the study is a significant lowering of BNP across the population, such that values for the population are reduced to levels below a predetermined threshold and kept below the threshold for the duration of subsequent testing and observation.|6 months|One subject enrolled but no data collected. Study terminated by sponsor.||||||
2584991|NCT02351037|Secondary|Clinical Benefit Rate - as Defined as the Proportion of Subjects Who Achieve CR, CRi, Morphologic Leukemia-free State, or Partial Remission (PR)|To evaluate clinical benefit defined as CR, CRi, morphologic leukemia-free state, and partial remission (PR).|When the last subject enrolled completes approximately 12 months of treatment|||||||
2584992|NCT02351037|Secondary|Relapse-free Survival (RFS), Event-free Survival (EFS) and Overall Survival (OS)|To evaluate clinical efficacy by assessing relapse-free survival (RFS), event-free survival (EFS) and overall survival (OS).|When the last subject enrolled completes approximately 12 months of treatment|||||||
2584993|NCT02351037|Primary|Safety and Tolerability of Ibrutinib Monotherapy or in Combination With Either LD-AraC or Azacitidine|Number of Participants with Adverse Events and number of patients with lab abnormalities.The safety profile of ibrutinib was evaluated based on the incidence of adverse events (AEs) as well as clinically significant laboratory abnormalities and vital signs, and other malignancies. The safety evaluations performed in this study were standard and/or were required based on the safety data available from other clinical and preclinical settings.|Up to 30 days following the last dose of study drug.|||||||
2584994|NCT02351037|Primary|Efficacy of Ibrutinib Monotherapy or in Combination With Either LD-AraC or Azacitidine Using the Overall Remission Rate (Defined as Proportion of Subjects Achieving a CR or CRi) According to the LeukemiaNet Guidelines|Dohner's 2000 Criteria for AML: Complete Response (CR), Bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count > 1.0 x 109/L (1000/µL); platelet count >100 x 109/L (100 000/µL); independence of red cell transfusions; CR with Incomplete Recovery (CRi), All CR criteria except for residual neutropenia (< 1.0 x 109/L [1000/µL]) or thrombocytopenia (<100 x 109/L [100 000/µL]) ; Morphologic leukemia-free state, Bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required; Partial Remission (PR), All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%; Relapse, Bone marrow blasts > 5%; or reappearance of blasts in the blood; or development of extramedullary disease.|When the last subject enrolled completes approximately 12 months of treatment.||||Participants|||Count of Participants
2584995|NCT02350881|Secondary|Survival of the Implant.|The survival of the implant is evaluated according to the number of implant revisions or of reoperations, whatever the reason.|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort|||percentage of implants|Participants||Number
2584996|NCT02350881|Primary|Pain at Rest|"Subjective evaluation of patients about ther pain at rest, postoperatively versus preoperatively. Patients had to choose among 4 variables : disappeared, less, same, greater."|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort|||Number of Implants|Participants||Number
2584997|NCT02350881|Primary|Pain During Walking|"Subjective evaluation by patients about pain during walking, postoperatively versus preoperatively. Patients had to choose among 4 variables : disappeared, less, same, greater."|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort|||Number of Implants|Participants||Number
2584998|NCT02350881|Primary|Walking Perimeter|"Subjective evaluation by the patients of their walking perimeter, postoperatively versus preoperatively. Patient had to choose among 3 variables : improved, same, worsened."|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort|||Number of Implants|Participants||Number
2584999|NCT02350881|Primary|Pain at Pressure of MTP1|Number of patients reporting pain at pressure of MTP1 at preoperative and postoperative visits.|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort|||Number of Implants|Participants||Number
2585000|NCT02350881|Secondary|Bone Resorption|Bone resorption evaluation was described as : absent or present. Radiological evaluations were performed from available frontal and lateral view X-rays.|mean 6.9 years (range, 5.5 - 9.5)|Overall cohort|||percentage of implants|Participants||Number
2585001|NCT02350881|Secondary|Osteolysis|Osteolysis evaluation was described as : absent or present. Radiological evaluations were done from available frontal and lateral view X-rays.|mean 6.9 years (range, 5.5 - 9.5)|Overall cohort|||percentage of implants|Participants||Number
2585002|NCT02350881|Primary|Pain at Passive Motion of MTP1|Number of patients reporting pain at passive motion of MTP1 at preoperative and postoperative visits.|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort|||Number of Implants|Participants||Number
2585003|NCT02350881|Primary|AOFAS Hallux-MTP-IP - PAIN Score|Pain is a sub-score of the AOFAS Hallux-MTP-IP score and is measured on a scale of 40 points - the higher value represents a minimal pain.|mean follow-up of 6.9 years (range, 5.2 - 9.5)|Overall cohort|||units on a scale|Participants|Standard Deviation|Mean
2585312|NCT02347085|Secondary|Peak Change From Baseline in IC Following the Morning Dose on Day 29|Peak Change from Baseline in IC following the morning dose on Day 29|Day 29|MITT Population|||Liters||95% Confidence Interval|Mean
2585004|NCT02350881|Primary|AOFAS Hallux-MTP-IP Score - Overall|"AOFAS (American Orthopedic Foot and Ankle Society) Hallux-MTP-IP (Hallux-Meta-Tarso-Phalangeal-Inter-Phalangeal) score is composed of 3 sub-scores : (i) Pain score is ranging from 0 to 40 points ; Function score is ranging from 0 to 45 points ; Alignment is ranging from 0 to 15 points. The AOFAS total score is then ranging from 0 to 100 points. A result over 80 points is considered good, below 20 points as bad."|mean 6.9 years follow-up (range 5.2 - 9.5)|number of implants analyzed (70 implants in 64 patients)|||units on a scale|Participants|Standard Deviation|Mean
2585005|NCT02350816|Secondary|Change From Baseline in Total Cortical Grey Matter Volume|The total cortical grey matter volume was assessed by volumetric magnetic resonance imaging (MRI) of the brain. Due to the premature termination of the treatment period, efficacy data were not analyzed and no efficacy conclusions were drawn.|Baseline, Week 120|No participant was analyzed due to the premature termination of the treatment period of this study.||||||
2585006|NCT02350816|Secondary|Change From Baseline in the Developmental Quotient (DQ) Assessed by Neurocognitive Tests|The development quotient (DQ) was to express a neurodevelopmental/cognitive delay which was computed as a ratio and expressed as a percentage using the age equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range: 0, 100). Higher scores are indicative of decreased development. Neurocognitive tests included Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III), Kaufman Assessment Battery for Children, Second Edition (KABC-II), Vineland Adaptive Behavior Scales, Second Edition (VABS-II). Due to the premature termination of the treatment period, efficacy data were not analyzed and no efficacy conclusions were drawn.|Baseline, Week 120|No participant was analyzed due to the premature termination of the treatment period of this study.||||||
2585007|NCT02350816|Secondary|Change From Baseline Vineland Adaptive Behavior Scales Second Edition (VABS-II)|VABS-II measured adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. It was an instrument that supports the diagnosis of intellectual and developmental disabilities in participants. This test measured 5 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite ((a composite of the other four domains). Scoring was 'Usually' = 2, 'Sometimes'/Partially' = 1 or 'Never' = 0. The raw scores was converted to domain standard scores (mean 100, SD 15). Higher scores indicate undesirable behavior. Due to the premature termination of the treatment period, efficacy data were not analyzed and no efficacy conclusions were drawn.|Baseline, Week 120|No participant was analyzed due to the premature termination of the treatment period of this study.||||||
2585008|NCT02350816|Primary|Levels of Glycosaminoglycan (GAG) Concentration in Urine|Levels of GAG concentration in Urine were reported. Last measurable data was presented for respective participant up to their last available time point.|Up to Week 120|Safety population consisted of all participants who had the IDDD implant or received at least 1 dose of investigational product in the extension study (SHP610-201 [NCT02350816]). Here the number of participants analyzed signifies participants who were evaluable for this measure at specific category.|||percentage of GAG|||Number
2585009|NCT02350816|Primary|Levels of Glycosaminoglycan (GAG) Concentration in Cerebro Spinal Fluid (CSF)|Levels of GAG concentration in CSF was reported. Last measurable data was presented for respective participant up to their last observed time point.|Up to Week 120|Safety population consisted of all participants who had the IDDD implant or received at least 1 dose of investigational product in the extension study (SHP610-201 [NCT02350816]). Here the number of participants analyzed signifies participants who were evaluable for this measure at specific category.|||micromoles (μmol)|||Number
2585010|NCT02350816|Primary|Area Under Curve (AUC) of Recombinant Human Heparan N-Sulfatase (rhHNS) Concentration in Serum|No sufficient PK samples were collected and analyzed due to early termination of the study.|Week 0, 48 and 96|No sufficient pharmacokinetic (PK) samples were collected and analyzed due to early termination of the study.||||||
2585011|NCT02350816|Primary|Area Under Curve (AUC) of Recombinant Human Heparan N-Sulfatase (rhHNS) Concentration in Cerebro Spinal Fluid (CSF)|No sufficient pharmacokinetic (PK) samples were collected and analyzed due to early termination of the study.|Week 0 and 48|No sufficient PK samples were collected and analyzed due to early termination of the study.||||||
2585012|NCT02350816|Primary|Number of Participants With Positive Anti-Recombinant Human Heparan N-Sulfatase (rhHNS) Antibody Status in Serum|Number of participants with positive anti-rhHNS antibody status in serum were reported.|Up to 120 weeks|Safety population consisted of all participants who had the IDDD implant or received at least 1 dose of investigational product in the extension study (SHP610-201 [NCT02350816]). The last observed time point data was presented for outcome measure data.|||Participants|||Count of Participants
2585013|NCT02350816|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on Type, Severity and Relationship to Treatment Drug|An AE was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. TEAEs was defined as all AEs from the time of initial IDDD implantation (or first dose if earlier) in either Study NCT02060526 (HGT-SAN-093) or Study NCT02350816 (SHP-610-210) to the data cutoff date (28 Jun 2017), or 30 days after the date of the last dose or 2 weeks after the date of device explant (whichever was later) if early termination occurred. Treatment-emergent AEs were summarized by type (serious, life-threatening), severity (mild, moderate, severe) and degree of relationship to investigational product (Intrathecal Drug Delivery Device (IDDD), device surgical procedure, or intraThecal administration of HGT-1410).|From start of study drug administration up to follow-up (Week 276)|Safety population consisted of all participants who had the IDDD implant or received at least 1 dose of investigational product in the extension study (SHP610-201 [NCT02350816]).|||Participants|||Number
2585014|NCT02350777|Primary|Peripheral Blood Counts Recovery (Response Will be Defined by Stable Blood Counts (ANC>1000, Hb>8 With Absolute Reticulocyte Count>20x10^9/L ,and Plt>50,000) Without Support of Blood Product Transfusions and/or Growth Factors.|will be documented by CBC checks every 2 weeks. Response will be defined by stable blood counts (ANC>1000, Hb>8 with absolute reticulocyte count>20x10^9/L ,and Plt>50,000) without support of blood product transfusions and/or growth factors.|1 year|No data were collected||||||
2585015|NCT02350569|Secondary|Percentage of Participants With HCV RNA < LLOQ While on Treatment at Days 1, 3, 5, 7, 14, 21, and 28||Days 1, 3, 5, 7, 14, 21, and 28|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2585016|NCT02350569|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~End of treatment virologic failure:~Completed 28 days LDV/SOF treatment and had HCV RNA ≥ LLOQ at last measurement on treatment~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment HCV RNA measurement."|Up to Posttreatment Week 12|Full Analysis Set: participants who were enrolled into the study, received a liver transplant while on study, and received at least 1 dose of study drug|||percentage of participants|||Number
2585017|NCT02350569|Secondary|Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set: participants who were enrolled into the study, received a liver transplant while on study, and received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2585018|NCT02350569|Primary|Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event||Up to 4 weeks|Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug|||percentage of participants|||Number
2585019|NCT02350569|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled into the study, received a liver transplant while on study, and received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2585020|NCT02350478|Secondary|Changes in Biochemical Markers (svCAM-1)|Soluble cell adhesion molecules-1 (svCAM-1) of endothelial function from baseline to 12 weeks|12 weeks||||ng/ml||Standard Deviation|Mean
2585021|NCT02350478|Secondary|Changes in the Area Under Curve (AUC) of Free Fatty Acids During the Meal Tolerance Test From Baseline to 12 Weeks|"The Area under the curve was calculated for glucose, insulin and for the free fatty acids based on the trapezoidal rule with baseline value as the mean of the values at time points -5 and 0 minutes.~The MTT was performed after an overnight fast (apart from water). A pre-meal blood sample will be taken (-5mins) and then all subjects will be asked to drink Fortimel compact (10 kcal/kg) over a period of 2-4 mins (time 0 mins). During the mixed meal test further blood samples will be taken at 15, 30, 60, and 120 minutes. All samples will be used for the determination of glucose, insulin and free fatty acids. The blood at each time point will be placed into a fluoride oxalate tube (1ml) for plasma glucose and into a serum tube for insulin and free fatty acids."|12 weeks||||µmol*min/l||Standard Deviation|Mean
2585022|NCT02350478|Secondary|Changes in the Area Under Curve (AUC) of Glucose, Insulin and C-peptide During the Meal Tolerance Test From Baseline to 12 Weeks|"The Area under the curve was calculated for glucose, insulin and for the free fatty acids based on the trapezoidal rule with baseline value as the mean of the values at time points -5 and 0 minutes.~The Meal Tolerance Test (MTT) was performed after an overnight fast (apart from water). A pre-meal blood sample will be taken (-5mins) and then all subjects will be asked to drink Fortimel compact (10 kcal/kg) over a period of 2-4 mins (time 0 mins). During the mixed meal test further blood samples will be taken at 15, 30, 60, and 120 minutes. All samples will be used for the determination of glucose, insulin and free fatty acids. The blood at each time point will be placed into a fluoride oxalate tube (1ml) for plasma glucose and into a serum tube for insulin and free fatty acids."|12 weeks||||mg*min/dl||Standard Deviation|Mean
2585023|NCT02350478|Secondary|Changes in Biochemical Markers (sICAM-1)|Soluble cell adhesion molecules-1 (sICAM-1) of endothelial function from baseline to 12 weeks|12 weeks||||ng/ml||Inter-Quartile Range|Median
2585024|NCT02350478|Secondary|Changes in Global Arginine Bioavailability Ratio (Ratio of Arginine to [Ornithine + Citrulline]) and Arginine to Ornithine Ratio From Baseline to 12 Weeks|Arginine, ornithine and citrulline will be measured in serum samples with a conventional usual amino acid analysis technique, involving separation of amino acids by ion exchange chromatography followed by postcolumn continuous reaction with ninhydrin. Global arginine bioavailability ratio (GABR) will be calculated by L-arginine divided by the sum of (L-ornithine plus L-citrulline). The arginine to ornithine ratio will be calculated by dividing L-arginine by L-ornithine levels.|12 weeks||||Ratio||Standard Deviation|Mean
2585025|NCT02350478|Primary|Changes in Endothelial Function (FMD - Flow Mediated Dilatation) From Baseline to 12 Weeks|"Endothelium-dependent FMD following reactive hyperaemia was examined in the brachial artery according to the guidelines described by Coretti et al (J Am Coll Cardiol. 2002;39(2):257-65). FMD-diameter is calculated as the average of the three diameter measurements following reactive hyperaemia. FMD was calculated as the percent change in diameter compared to baseline. Flow-mediated dilation is reported such as percentage of change in diameter (%)."|12 weeks||||percentage of change in diameter (%)||Standard Deviation|Mean
2585026|NCT02350309|Secondary|Relationship Between PK Concentrations of Lemborexant and Sleepiness as Measured by M-MSLT|Pearson correlation was used to calculate the relationship between PK concentration of lemborexant and sleepiness. The M-MSLT is a widely used method for objectively quantifying excessive, pathological, or pharmacologically induced residual sleepiness by measuring the number of minutes that it takes a participant to fall asleep. The MSLT was modified to include four SLTs, with the first starting at 45 minutes after morning wake time, and the subsequent three occurring at 30-minute intervals for a total of 4 SLT's per M-MSLT. Each SLT was scored to determine the latency in minutes (with precision to 0.5 minute) from lights off to sleep onset; trials during which sleep onset did not occur were assigned a latency of 20 minutes.|Baseline up to Day 44 (Week 6)|The PK analysis set was the group of participants who received at least one dose of E2006 and had at least one quantifiable postdose drug concentration. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.|||correlation coefficient|||Number
2585027|NCT02350309|Secondary|Number of Participants With Clinically Significant Shifts From Baseline in Electrocardiogram (ECG) Parameters||From first dose of study drug up to Day 54|The safety analysis set was the group of participants who received at least one dose of study drug and had at least 1 postdose safety assessment.|||Participants|||Count of Participants
2585028|NCT02350309|Secondary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values||From first dose of study drug up to Day 54|The safety analysis set was the group of participants who received at least one dose of study drug and had at least 1 postdose safety assessment.|||Participants|||Count of Participants
2585029|NCT02350309|Secondary|Number of Participants With Clinically Significant Abnormal Laboratory Values||From first dose of study drug up to Day 54|The safety analysis set was the group of participants who received at least one dose of study drug and had at least 1 postdose safety assessment.|||Participants|||Count of Participants
2585030|NCT02350309|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) That Led to Death and Study Drug Discontinuation||From first dose of study drug up to Day 54|The safety analysis set was the group of participants who received at least one dose of study drug and had at least 1 postdose safety assessment.|||Participants|||Count of Participants
2585031|NCT02350309|Secondary|Mean Plasma Concentrations of Lemborexant and Metabolite M10 in the Morning Following M-MSLT|The MSLT is a widely used method for objectively quantifying excessive, pathological, or pharmacologically induced residual sleepiness by measuring the number of minutes that it takes a participant to fall asleep. The MSLT was modified to include four SLTs, with the first starting at 45 minutes after morning wake time, and the subsequent three occurring at 30-minute intervals for a total of 4 SLT's per M-MSLT.|Days 2, 16 and 30 within 20 minutes after the end of 4th SLT (up to 155 minutes after wake time)|The pharmacokinetic (PK) analysis set was the group of participants who received at least one dose of lemborexant and had at least one quantifiable postdose drug concentration. The PK analysis set where data at specified time points was available.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2585032|NCT02350309|Secondary|Mean Change From Baseline in the Average SOL From the M-MSLT in Treatment Period 4|SOL is defined as the length of time that it takes to accomplish the transition from full wakefulness to sleep. The MSLT is a widely used method for objectively quantifying excessive, pathological, or pharmacologically induced residual sleepiness by measuring the number of minutes that it takes a participant to fall asleep. The MSLT was modified to include four SLTs, with the first starting at 45 minutes after morning wake time, and the subsequent three occurring at 30-minute intervals for a total of 4 SLT's per M-MSLT. Each SLT was scored to determine the latency in minutes (with precision to 0.5 minute) from lights off to sleep onset; trials during which sleep onset did not occur were assigned a latency of 20 minutes. The four SLTs for each participant were averaged to obtain the mean SOL.|Baseline, Day 2 of Treatment Period 4 (Week 6)|The FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose PD measurement.|||minutes||Standard Deviation|Mean
2585033|NCT02350309|Secondary|Number of Participants Whose Average SOL is <8.0 Minutes and >6.0 Minutes Shorter Than Placebo|SOL is defined as the length of time that it takes to accomplish the transition from full wakefulness to sleep. The MSLT is a widely used method for objectively quantifying excessive, pathological, or pharmacologically induced residual sleepiness by measuring the number of minutes that it takes a participant to fall asleep. The MSLT was modified to include four SLTs, with the first starting at 45 minutes after morning wake time, and the subsequent three occurring at 30-minute intervals for a total of 4 SLT's per M-MSLT. Each SLT was scored to determine the latency in minutes (with precision to 0.5 minute) from lights off to sleep onset; trials during which sleep onset did not occur were assigned a latency of 20 minutes. The four SLTs for each participant were averaged to obtain the mean SOL.|Day 2 of each of three treatment periods that are separated by approximately 2 weeks (for a total of up to 6 weeks)|The FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose PD measurement. Participants who were evaluable for this given measure at a given time point were included for this assessment.|||Participants|||Count of Participants
2585034|NCT02350309|Secondary|Number of Participants Whose Treatment Difference (Under Either Dose of Lemborexant) Average SOL Score is More Than (>) 6.0 Minutes Shorter Than Placebo|SOL is defined as the length of time that it takes to accomplish the transition from full wakefulness to sleep. The MSLT is a widely used method for objectively quantifying excessive, pathological, or pharmacologically induced residual sleepiness by measuring the number of minutes that it takes a participant to fall asleep. The MSLT was modified to include four SLTs, with the first starting at 45 minutes after morning wake time, and the subsequent three occurring at 30-minute intervals for a total of 4 SLT's per M-MSLT. Each SLT was scored to determine the latency in minutes (with precision to 0.5 minute) from lights off to sleep onset; trials during which sleep onset did not occur were assigned a latency of 20 minutes. The four SLTs for each participant were averaged to obtain the mean SOL.|Day 2 of each of three treatment periods that are separated by approximately 2 weeks (for a total of up to 6 weeks)|The FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose PD measurement. Participants who were evaluable for this given measure at a given time point were included for this assessment.|||Participants|||Count of Participants
2585035|NCT02350309|Secondary|Number of Participants With an Average SOL of Less Than (<) 8.0 Minutes for Each Treatment|SOL is defined as the length of time that it takes to accomplish the transition from full wakefulness to sleep. The MSLT is a widely used method for objectively quantifying excessive, pathological, or pharmacologically induced residual sleepiness by measuring the number of minutes that it takes a participant to fall asleep. The MSLT was modified to include four SLTs, with the first starting at 45 minutes after morning wake time, and the subsequent three occurring at 30-minute intervals for a total of 4 SLT's per M-MSLT. Each SLT was scored to determine the latency in minutes (with precision to 0.5 minute) from lights off to sleep onset; trials during which sleep onset did not occur were assigned a latency of 20 minutes. The four SLTs for each participant were averaged to obtain the mean SOL.|Day 2 of each of three treatment periods that were separated by approximately 2 weeks (for a total of up to 6 weeks)|The FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose PD measurement.|||Participants|||Count of Participants
2585051|NCT02349542|Secondary|Plasma Bupivacaine Levels|Blood samples will be drawn and analyzed to establish levels of bupivacaine detectable in the blood. Blood samples will be drawn at baseline (prior to injection), upon injection, at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours post-injection and analyzed to determine levels of bupivacaine present.|Up to 72 hours following injection|Blood draws were collected at the pre-defined intervals unless the patient was discharged prior to the blood collection time. 6 patients were discharged prior to the 48 hour collection time. 5 additional patients were discharged prior to the 72 hour collection time.|||ug/ml||Standard Deviation|Mean
2585052|NCT02349542|Primary|Adverse Events|Number of Participants with Adverse Events|Up to 72 hours following injection||||participants|||Number
2585036|NCT02350309|Primary|Mean Change From Baseline in the Average Sleep Onset Latency (SOL) From Modified-Multiple Sleep Latency Test (M-MSLT) for Each Treatment in Treatment Periods 1 to 3|SOL is defined as the length of time that it takes to accomplish the transition from full wakefulness to sleep. The multiple sleep latency test (MSLT) is a widely used method for objectively quantifying excessive, pathological, or pharmacologically induced residual sleepiness by measuring the number of minutes that it takes a participant to fall asleep. The MSLT was modified to include four Sleep Latency Tests (SLTs), with the first starting at 45 minutes after morning wake time, and the subsequent three occurring at 30-minute intervals for a total of 4 SLT's per M-MSLT. Each SLT was scored to determine the latency in minutes (with precision to 0.5 minute) from lights off to sleep onset; trials during which sleep onset did not occur were assigned a latency of 20 minutes. The four SLTs for each participant were averaged to obtain the mean SOL.|Baseline, Day 2 of each of three treatment periods that were separated by approximately 2 weeks (for a total of up to 4 weeks)|The full analysis set (FAS) was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose pharmacodynamics (PD) measurement.|||minutes||Standard Deviation|Mean
2585037|NCT02349789|Primary|Change in Gait Speed- Cathodal_Off|Change in overground walking speed (10 meter walk test) after cathodal transcranial direct current stimulation, participants off medication.|One session||||meters per second (m/s)||Standard Error|Mean
2585038|NCT02349789|Primary|Change in Gait Speed- Cathodal_On|Change in overground walking speed (10 meter walk test) after Cathodal transcranial direct current stimulation, participants on medication.|One session||||meters per second (m/s)||Standard Error|Mean
2585039|NCT02349789|Primary|Change in Gait Speed- Anodal_Off|Change in overground walking speed (10 meter walk test) after Anodal transcranial direct current stimulation, participants off medication.|One session||||meters per second (m/s)||Standard Error|Mean
2585040|NCT02349789|Primary|Change in Gait Speed- Anodal_On|Change in overground walking speed (10 meter walk test) after Anodal transcranial direct current stimulation, participants on medication.|One session||||meters per second (m/s)||Standard Error|Mean
2585041|NCT02349789|Primary|Change in Gait Speed- Sham_Off|Change in overground walking speed (10 meter walk test) after Sham transcranial direct current stimulation, participants off medication.|One session||||meters per second (m/s)||Standard Error|Mean
2585042|NCT02349789|Primary|Change in Gait Speed- Sham_On|Change in overground walking speed (10 meter walk test) after Sham transcranial direct current stimulation, participants on medication.|One session||||meters per second (m/s)||Standard Error|Mean
2585043|NCT02349711|Secondary|Regulatory T Cells (Tregs)|Regulatory T cells (Tregs) as a percentage of CD4+ T cells, quantified via flow cytometry|baseline and week 6|A subgroup of participants who completed the main study (questionnaire data only) also completed an additional portion of the study in which they provided blood and stool samples. Some samples could not be accurately measured for this outcome, so those samples were excluded from analysis.|||percentage of CD4+ T lymphocytes||Standard Error|Least Squares Mean
2585044|NCT02349711|Secondary|Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire|Symptoms included in this score are constipation, hard stools, and feeling of incomplete evacuation reported on a weekly Gastrointestinal Symptom Response Scale (GSRS) questionnaire. Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.|weeks 0, 1, 2, 3, 4, 5, 6, 7|Since this outcome had more than two time points, and since all randomized participants provided some weeks of survey data, all participants were included in the analysis (even those that were lost to follow up). The number of values (and thus the number analyzed) by week is also shown.|||units on a scale||Standard Error|Mean
2585045|NCT02349711|Secondary|Serum Total Immunoglobulin E (IgE)|Serum total immunoglobulin E (IgE) was quantified via ELISA|baseline and week 6|A subgroup of participants who completed the main study (questionnaire data only) also completed an additional portion of the study in which they provided blood and stool samples.|||ng/mL||Standard Error|Mean
2585046|NCT02349711|Primary|Change in Health-related Quality of Life Score From Baseline to the Peak Week of Allergy Season for Probiotic Versus Placebo, as Measured by MiniRQLQ|MiniRQLQ, global score (0=not troubled, 6=extremely troubled; an average of the 14 questions; includes all domains)|up to 8 weeks from date of randomization|"Because this was an intent-to-treat study, all data from all randomized participants was considered for analysis. No imputation was done, so missing values excluded a participant from the analysis. While data from a participant may be missing, they were considered to have completed the study if they completed all study visits."|||units on a scale||Standard Error|Least Squares Mean
2585047|NCT02349685|Secondary|Number of Participants in Each Arm/Group With Successful H. Pylori Eradication|"the efficacy of H. pylori eradication between a personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens.~The eradication rate was evaluated by per-protocol analysis (PP)"|6 weeks after completion of eradication||||participants|||Number
2585048|NCT02349685|Primary|Number of Participants in Each Arm/Group With Successful H. Pylori Eradication|"the efficacy of H. pylori eradication between a personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens.~The eradication rate was evaluated by intention to treat (ITT)"|6 weeks after completion of eradication||||participants|||Number
2585049|NCT02349646|Primary|Percentage of Subjects With at Least 50% Pain Reduction|Percent of subjects with at least a 50% reduction. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).|3, 6 and 12-Month Visits|Differences in participants over time is due to early withdrawals and missing data|||Participants|||Count of Participants
2585050|NCT02349646|Primary|Change in Pain Intensity for Overall Pain From Pre-treatment Baseline|The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).|Baseline, 3, 6 and 12-Month Visits|Differences in participants over time is due to early withdrawals and missing data|||units on a scale||Standard Deviation|Mean
2585053|NCT02349477|Other Pre-specified|Number of Participants With No Drinking Days by AWS Score and Medication|This analysis examines the interaction of medication group with a median split of the baseline Alcohol Withdrawal Scale (AWS) scores on the primary outcome variable (no heavy drinking days, corrected for %dCDT). Participants will report their daily alcohol use with using a daily calendar. AWS ranges from 0 to 44 where higher values correspond with more serious withdrawal (worse outcome).|4 months|The data for this analysis were split into two subgroups, based on the median split of AWS.|||Participants|||Count of Participants
2585054|NCT02349477|Secondary|Percent of Subjects With no Drinking Days (PSNDD)|The secondary dependent variable will be percent of subjects with no drinking days (total abstinence). Participants will report their daily alcohol use with using a daily calendar. Abstinence is corrected for %dCDT.|4 months||||Participants|||Count of Participants
2585055|NCT02349477|Primary|Percent of Subjects With no Heavy Drinking Days (PSNHDD)|The primary dependent variable will be the percent of subjects with no heavy drinking days (4 or more standard drinks for women and 5 or more standard drinks for men). Participants will report their daily alcohol use with using a daily calendar. No heavy drinking days is corrected for %dCDT.|4 months||||Participants|||Count of Participants
2585056|NCT02349451|Secondary|Change From Baseline in Psoriasis Target Lesion Score at Week 12|Target lesion score for psoriasis in participants with psoriatic arthritis is calculated by adding the scores of plaque erythema, scaling and thickness. Scores range from 0 (no erythema or evidence of plaque thickness) to 10 (severe erythema and evidence of plaque thickness).|Baseline, Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. LOCF: missing responses are imputed by calculation based on the last non-missing post-baseline component values.|||units on a scale||95% Confidence Interval|Least Squares Mean
2585057|NCT02349451|Secondary|Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Week 12|PASDAS is a continuous compound disease activity state score determined by the combined values of tender or swollen joint counts, participant-reported outcome and hsCRP lab test. The PASDAS is unitless, with a typical score range between 0 and 10. Smaller values on PASDAS indicate a better condition; a negative change from baseline indicates improvement.|Baseline, Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. LOCF: missing responses are imputed by calculation based on the last non-missing post-baseline component values.|||units on a scale||95% Confidence Interval|Least Squares Mean
2585058|NCT02349451|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28[hsCRP]) at Week 12|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10, with higher scores indicating more disease activity.|Baseline, Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. LOCF: missing responses are imputed by calculation based on the last non-missing post-baseline component values.|||units on a scale||95% Confidence Interval|Least Squares Mean
2585059|NCT02349451|Secondary|ACRn at Week 12|ACR measures percentage improvements in tender and swollen joint counts, patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant. ACRn is a continuous variable based on the ACR criteria. Improvement from baseline in a component of the ACR composite variable was computed as the difference between the baseline value and the value at a given post-baseline visit. A positive value for improvement from baseline for an individual component indicates lesser severity of disease. The 95% confidence interval for mean is constructed using T-statistic with significance level alpha=5%.|At Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Last observation carried forward (LOCF): missing responses are imputed by calculation based on the last non-missing post-baseline component values.|||percentage improvement||95% Confidence Interval|Mean
2585060|NCT02349451|Secondary|ACR70 Response Rate at Week 12|Percentage of participants with an ACR70 response, defined as at least 70% improvement (compared to baseline values) in tender and swollen joint counts and at least 70% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.|Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. NRI: missing responses are imputed as non-responders.|||percentage of participants||95% Confidence Interval|Number
2585061|NCT02349451|Secondary|ACR50 Response Rate at Week 12|Percentage of participants with an ACR50 response, defined as at least 50% improvement (compared to baseline values) in tender and swollen joint counts and at least 50% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP. Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.|Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. NRI: missing responses are imputed as non-responders.|||percentage of participants||95% Confidence Interval|Number
2585062|NCT02349451|Secondary|ACR20 Response Rate at Week 12: ABT-122 Versus Adalimumab|Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant hsCRP). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.|Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. NRI: missing responses are imputed as non-responders.|||percentage of participants||95% Confidence Interval|Number
2585082|NCT02349295|Secondary|Percentage of Participants Achieving ACR 50||Week 52 and up to 3 Years||2020-07-31|07/2020||||
2585083|NCT02349295|Secondary|Percentage of Participants Achieving ACR20||Week 52 and up to 3 Years||2020-07-31|07/2020||||
2585313|NCT02347085|Secondary|Peak Change From Baseline in Inspiratory Capacity (IC) Following the Evening Dose on Day 29|Peak Change from Baseline in Inspiratory Capacity (IC) following the evening dose on Day 29|Day 29|MITT Population|||Liters||95% Confidence Interval|Mean
2585063|NCT02349451|Primary|American College of Rheumatology (ACR) 20 Response Rate at Week 12: ABT-122 Versus Placebo|Percentage of participants with an ACR20 response, defined as at least 20% improvement (compared to baseline values) in tender and swollen joint counts and at least 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function and acute phase reactant high sensitivity C-reactive protein [hsCRP]). Estimates of the 95% confidence interval of the response rates for each treatment group were calculated using the Agresti-Coull method.|Week 12|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Non-responder imputation (NRI): missing responses are imputed as non-responders.|||percentage of participants||95% Confidence Interval|Number
2585064|NCT02349438|Primary|Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink|Wavefront metric measured by COAS wavefront sensor while subject fixates a distant target in primary gaze with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.|2 hours post insertion|All subjects that have completed all study visits.|||microns||Standard Deviation|Mean
2585065|NCT02349438|Primary|Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink|Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.|2 hours post insertion|All subjects that have completed all study visits.|||microns||Standard Deviation|Mean
2585066|NCT02349438|Primary|Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking|Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with natural blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.|2 hours post insertion|All subjects that have completed all study visits.|||microns||Standard Deviation|Mean
2585067|NCT02349412|Secondary|Concordance Between Patient and Family Caregiver Report of Prognosis/Curability||Up to 3 years|||||||
2585068|NCT02349412|Secondary|Overall Survival||Up to 3 years|||||||
2585069|NCT02349412|Secondary|Chemotherapy and Radiation Administration||Up to 3 years|||||||
2585070|NCT02349412|Secondary|Number of Hospital and Intensive Care Unit (ICU) Admissions and Days||Up to 3 years|||||||
2585071|NCT02349412|Secondary|Location of Death||Up to 3 years|||||||
2585072|NCT02349412|Secondary|Rate of Referral, Enrollment and Length of Stay on Hospice||Up to 3 years|||||||
2585073|NCT02349412|Secondary|Change in QOL on the SF-36 Over Time||Up to 3 years|||||||
2585074|NCT02349412|Secondary|"Prognostic Understanding at Week-12 as Measured by Have You and Your Oncologist Discussed Any Particular Wishes About the Care You Would Want to Receive if You Were Dying? Question on the Prognosis and Treatment Perceptions Questionnaire"|"Prognostic Understanding at Week-12 as measured by Prognosis and Treatment Perceptions Questionnaire: Have you and your oncologist discussed any particular wishes about the care you would want to receive if you were dying? responses at Week-12 are reported below."|Up to 12 weeks|Only participants with available data on the individual study measure at week 12 were included in the analysis.|||Participants|||Count of Participants
2585075|NCT02349412|Secondary|Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Anxiety|Quality of Life (QOL) was measured using the Hospital Anxiety and Depression Scale (HADS) - Anxiety on a 0-21 scale, with lower scores corresponding to lower anxiety and higher scores corresponding to higher anxiety. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Lower scores on the HADS-Anxiety indicate less anxiety symptoms.|Up to 12 weeks|Only participants with available data on the individual study measure at baseline and 12 weeks were included in the analysis.|||units on a scale||Standard Deviation|Mean
2585076|NCT02349412|Secondary|Change in Quality of Life (QOL) From Baseline to Week 12 Per the Hospital Anxiety and Depression Scale (HADS) - Depression|Quality of Life (QOL) was measured using the Hospital Anxiety and Depression Scale (HADS) - Depression on a 0-21 scale, with lower scores corresponding to lower depression and higher scores corresponding to higher depression. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Lower scores on the HADS-Depression indicate less depression symptoms.|Up to 12 weeks|Only participants with available data on the individual study measure at baseline and 12 weeks were included in the analysis.|||units on a scale||Standard Deviation|Mean
2585077|NCT02349412|Secondary|Change in Quality of Life (QOL) From Baseline to Week 24 Per the Functional Assessment of Cancer Therapy-General (FACT-G)|Quality of Life (QOL) was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Change from baseline to week-24 was calculated by subtracting the baseline scores from the scores at week-24. Higher scores on FACT-G indicate better QOL.|Up to 24 weeks|Only participants with available data on the individual study measure at baseline and 24 weeks were included in the analysis.|||units on a scale||Standard Deviation|Mean
2585078|NCT02349412|Primary|Change in Quality of Life (QOL) From Baseline to Week 12 Per the Functional Assessment of Cancer Therapy-General (FACT-G)|Quality of Life (QOL) was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. Change from baseline to week-12 was calculated by subtracting the baseline scores from the scores at week-12. Higher scores on FACT-G indicate better QOL.|Up to 12 weeks|Only participants with available data on the individual study measure at baseline and 12 weeks were included in the analysis.|||units on a scale||Standard Deviation|Mean
2585079|NCT02349360|Secondary|Composite Measure of Blood Chemistry Profiles|Number of clinically relevant out of range values of the comprehensive metabolic panel and hemogram during intervention through washout period vs baseline.|13 weeks|Subjects completing intervention and final blood draw after 4 week washout period.|||events|||Number
2585080|NCT02349360|Primary|Number of Participants Reporting Adverse Events|The number of participants reporting Adverse Events was reported.|13 weeks|Subjects completing the probiotic and the placebo intervention.|||Participants|||Count of Participants
2585081|NCT02349295|Secondary|Percentage of Participants Achieving ACR 70||Week 52 and up to 3 years||2020-07-31|07/2020||||
2585084|NCT02349295|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Ixekizumab|The AUC(Tau,Steady State) is the area under the concentration-time curve for dosing interval (Tau) at steady state of ixekizumab (Tau is 28 days for 80 mg Q4W cohort, and is 14 days for 80mg Q2W cohort, respectively).|All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)|The PK Population included all enrolled participants who received at least one dose of the study drug and had evaluable ixekizumab PK data.|||mcg*day/mL||Geometric Coefficient of Variation|Geometric Mean
2585085|NCT02349295|Secondary|Pharmacokinetics (PK):Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Ixekizumab|The Ctrough is the minimum observed serum concentration at steady state of Ixekizumab. The Ctrough at Week 24 was reported.|All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)|The PK Population included all enrolled participants who received at least one dose of the study drug and had evaluable ixekizumab PK data.|||micograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2585086|NCT02349295|Secondary|Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)|Number of participants with positive treatment emergent anti-ixekizumab antibodies was summarized by treatment group.|Week 24|All randomized participants who received at least 1 dose of ixekizumab and had evaluable anti-ixekizumab antibody measurement.|||Participants|||Number
2585087|NCT02349295|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Mental Component Summary (MCS)|The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline and post baseline MCS data.|||Units on a Scale||Standard Error|Least Squares Mean
2585088|NCT02349295|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Physical Component Summary (PCS)|The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline and post baseline PCS data.|||Units on a Scale||Standard Error|Least Squares Mean
2585089|NCT02349295|Secondary|Change From Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score|"The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing no fatigue and 10 representing as bad as you can imagine. Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction."|Baseline, Week 24|All randomized participants who had baseline and post baseline fatigue NRS data.|||Units on a Scale||Standard Error|Least Squares Mean
2585090|NCT02349295|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score|The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline axial involvement defined as baseline BASDAI score >4, baseline BASDAI score and post baseline BASDAI score data.|||Units on a Scale||Standard Error|Least Squares Mean
2585091|NCT02349295|Secondary|Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)|The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in mg/L), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline and post baseline DAS28-CRP data.|||Units on a Scale||Standard Error|Least Squares Mean
2585140|NCT02348840|Primary|Referral Rates to Local Hospitals|TBAs refer pregnant women to local hospitals for further evaluation or treatment when a pregnancy complications are detected. The median adjusted monthly emergency referral rates (referrals/births) per 100 births for each time period are presented here.|Month 7, Month 12|All TBAs are included in this analysis.|||Referrals per 100 births||Inter-Quartile Range|Median
2585092|NCT02349295|Secondary|Change From Baseline in C-Reactive Protein (CRP)|C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline CRP data.|||milligram per liter (mg/L)||Standard Error|Least Squares Mean
2585093|NCT02349295|Secondary|Change From Baseline in Physicians Global Assessment of Disease Activity VAS|The investigator will be asked to give an overall assessment of the severity of the participant's current PsA activity using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline Physicians Global Assessment of Disease Activity VAS score.|||Units on a Scale||Standard Error|Least Squares Mean
2585094|NCT02349295|Secondary|Change From Baseline in Patients Global Assessment of Disease Activity VAS|The patient's overall assessment of his or her PsA activity will be recorded using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline Patients Global Assessment of Disease Activity VAS score.|||Units on a Scale||Standard Error|Least Squares Mean
2585095|NCT02349295|Secondary|Change From Baseline in Participants Assessment of Pain Visual Analog Scale (VAS)|The pain VAS is a participant-administered single-item scale designed to measure current joint pain from Psoriatic arthritis (PsA) using a 100-millimeter(mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by marking a vertical tick on the horizontal 100-mm scale, where the left end from 0 mm (no pain) to right end 100 mm (worst possible joint pain). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline TJC and SJC data.|||Units on a Scale||Standard Error|Least Squares Mean
2585096|NCT02349295|Secondary|Change From Baseline in Swollen Joint Count (SJC)|SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline SJC data.|||Swollen Joint Count||Standard Error|Least Squares Mean
2585097|NCT02349295|Secondary|Change From Baseline in Tender Joint Count (TJC)|TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline TJC data.|||Tender Joint Count||Standard Error|Least Squares Mean
2585098|NCT02349295|Secondary|Change From Baseline in Itch Numeric Rating Scale (NRS)|"The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participants itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction."|Baseline, Week 12|All randomized participants who had baseline psoriatic lesion(s) involving >=3% BSA, baseline itch NRS score and post baseline itch NRS score data.|||Units on a Scale||Standard Error|Least Squares Mean
2585099|NCT02349295|Secondary|Percentage of Patients Achieving Complete Resolution in Enthesitis as Assessed by the Leeds Enthesitis Index (LEI)|"The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). So, 0 indicates good score here."|Week 24|All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score data. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||Percentage of Participants|||Number
2585100|NCT02349295|Secondary|Percentage of Patients Achieving Minimal Disease Activity (MDA)|It uses a composite of 7 key outcome measures (includes PASI) used in PsA to encompass all of the domains of the disease to measure the overall state of a patients' disease. The LEI is used to assess tender entheseal points. Patients are classified as achieving MDA if they fulfill 5 of 7 outcome measures: 1. TJC ≤1, 2. SJC ≤1, 3. PASI total score ≤1 or BSA ≤3, 4. patient pain VAS score of ≤15, 5. patient global VAS score of ≤20, 6. HAQ-DI score ≤0.5, 7. tender entheseal points (6 entheseal points) ≤1.|Week 24|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||Percentage of Participants|||Number
2585141|NCT02348723|Secondary|Incidence of ISTH MBE, Stroke, Systemic Embolism, or TIA (Composite Endpoint Combining Safety and Efficacy|"Percentage of patients with ISTH MBE, stroke, systemic embolism, or TIA (composite endpoint combining safety and efficacy) are presented.~These are based on adjudicated data (blinded evaluation)"|during and up to 2 months post-ablation|AS|||percentage of participants|||Number
2585101|NCT02349295|Secondary|Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75|The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures.|Week 12|All randomized participants with baseline psoriatic lesion(s) involving ≥3% body surface area (BSA). NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||Percentage of Participants|||Number
2585102|NCT02349295|Secondary|Percentage of Participants Achieving American College of Rheumatology 70 Index (ACR70)|ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.|Week 24|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||Percentage of Participants|||Number
2585103|NCT02349295|Secondary|Percentage of Participants Achieving American College of Rheumatology 50 Index (ACR50)|ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.|Week 24|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||Percentage of Participants|||Number
2585104|NCT02349295|Secondary|Percentage of Participants Achieving ACR20|ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.|Week 12|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||Percentage of Participants|||Number
2585105|NCT02349295|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI is a participant reported questionnaire that measures disease-associated disability(physical function).It consists of 24 questions with 8 domains: dressing/grooming,arising,eating,walking,hygiene,reach,grip and other daily activities. The disability section scores the participant's self-perception on degree of difficulty (0=without any difficulty,1=with some difficulty,2=with much difficulty,3=unable to do)covering the 8 domains.The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability.The reported use of special aids/devices and/or the need for assistance of another person to perform these activities is assessed.Least Square (LS) mean calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment,baseline score,geographic region, TNFi experience,visit, treatment-by-visit interaction(itcn), geographic region-by-visit itcn,TNFi experience-by-visit itcn and baseline score-by-visit itcn.|Baseline, Week 24|All randomized participants.|||units on a scale||Standard Error|Least Squares Mean
2585106|NCT02349295|Primary|Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20)|ACR20 response is defined as a greater than or equal to (≥) 20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).|Week 24|All randomized participants. Non-responder Imputation (NRI) is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||Percentage of Participants|||Number
2585107|NCT02349178|Primary|Minimal Residual Disease|A bone marrow evaluation to determine study response and remission status will be performed on study Day 30 or upon adequate blood count recovery (ANC > 0.50 and platelet > 50,000), whichever occurs first. If the marrow is hypocellular and without evidence of normal tri-lineage hematopoiesis the marrow should be repeated at Day 42.|Day 30 or adequate blood recovery||||Participants|||Count of Participants
2585108|NCT02349152|Secondary|Glycemic Variability|Coefficient of variation in blood glucose levels. Denotes how large the fluctuations in blood glucose are. Higher numbers indicate increased variation.|From the start of induction till 24 hours postoperatively||||Percent of Mean Glucose Level||Full Range|Mean
2585109|NCT02349152|Secondary|Development of Chronic Pain|Telephonic call Numeric pain scale; Scale is 0-10, with 10 being the highest pain.|1, 3, 6 and 12 months after discharge from the hospital||||score on a scale||Inter-Quartile Range|Median
2585110|NCT02349152|Secondary|Wound Hyperalgesia|Von frey hair objective testing|96 hours postoperatively||||g/mm^2||Standard Deviation|Mean
2585111|NCT02349152|Secondary|Emergence From Anesthesia|Time to extubation after completion of surgery in the operating room and intensive care unit|Immediate postoperative period until 30 days post-operatively||||Hours||Full Range|Median
2585112|NCT02349152|Secondary|Postoperative Pain|Pain scores; Every day 6 hour for 48 hours postoperative period|Every day 6 hour for 48 hours postoperative period|This is a mixed model analysis to account for missing VAS values|||score on a scale||Standard Deviation|Mean
2585113|NCT02349152|Secondary|Society of Thoracic Surgery Patient Outcomes|Postoperative outcomes collected from the Society of Thoracic Surgery (STS) database. 30 day Mortality (outcome 1) and 30 day Readmission (outcome 2) cerebral vascular accident(outcome 3), prolonged mechanical ventilation (outcome 4), renal failure (outcome 5), atrial fibrillation (outcome 6), cardiac arrest (outcome 7)|30 day outcomes||||participants|||Number
2585114|NCT02349152|Secondary|Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml)|Adreno-corticotrophic hormone (ACTH), Growth Hormone (GH) and Glucagon (measured as pg/ml) taken at: Prebypass, cardiopulmonary bypass (2 samples: 30 mins after start of bypass (CPB 30) and end of bypass (CPB END), post-bypass and ICU 8 hours postoperative period|Perioperative period (Intraoperatively and 8 hours postoperatively)||||pg/ml||Full Range|Median
2585115|NCT02349152|Secondary|Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml)|Inflammatory mediator levels, Interleukin-1b (IL-1b), Interleukin 6 (IL-6) and Tumor Necrosis Factor Alpha (TNFa) (all measured in pg/ml) taken at: Prebypass, cardiopulmonary bypass (2 samples:30 min start of bypass (CPB-30) and end of bypass (CPB-END), postbypass, ICU 8 hours postoperative period|Perioperative period (Intraoperatively and 8 hours postoperatively)||||pg/ml||Full Range|Median
2585116|NCT02349152|Secondary|Stress Hormone Levels-Cortisol (µg/dl)|Serum cortisol levels (measured as µg/dl) taken at: Prebypass, cardiopulmonary bypass (2 samples: at start of bypass and end of bypass), postbypass, ICU 8 hours postoperative period|Perioperative period (Intraoperatively and 8 hours postoperatively)||||µg/dl||Full Range|Median
2585117|NCT02349152|Secondary|Intraoperative Pre-cardiopulmonary Bypass Hemodynamic Stability|Blood pressure (systolic, diastolic and mean), Heart rate every 5 minutes from induction of anesthesia till systemic heparinization before cardiopulmonary bypass|induction of anesthesia till systemic heparinization before cardiopulmonary bypass|Resources not available to analyze||||||
2585118|NCT02349152|Secondary|Total Postoperative Regular Insulin|Total units of regular insulin required post-operatively|From ICU Admission (After Surgery) Until 24 hours postoperatively||||International Units||Full Range|Median
2585119|NCT02349152|Secondary|Postoperative Blood Glucose|Mean and peak blood glucose levels postoperatively|From ICU Admission (After Surgery) Until 24 hours postoperatively||||mg/dl||Full Range|Median
2585120|NCT02349152|Secondary|Mean, Peak and Trough Intraoperative Blood Glucose (mg/dl)|Blood glucose measured every hour|Intraoperative period; Induction to end of surgery||||Mg/dL||Full Range|Median
2585121|NCT02349152|Secondary|Number of Blood Glucose Values > 180 mg%|Blood glucose values that exceed 180 mg% will be counted|Intraoperative period, Induction to end of surgery||||number of glucose values >180mg%||Full Range|Median
2585122|NCT02349152|Secondary|Insulin Requirement|Average dose of insulin (Units/ml) calculated for each group in the intraoperative period|Intraoperative period; Induction to end of surgery||||Units/ml||Full Range|Median
2585123|NCT02349152|Primary|Blood Glucose Values (More Than One ) > 180 mg%|"Percentage of patients with two or more intraoperative blood glucose levels greater than 180 mg/dl. Percentage in both groups will be estimated, then the difference in this statistic will form the primary outcome measure of this study.~(Primary Outcome changed on 06/15/2015-Change Approved by University of Pittsburgh IRB on 06/22/2015- First patient enrolled January 2016)"|Intraoperative period||||Participants|||Count of Participants
2585124|NCT02349061|Secondary|Change From Baseline in Number of Joints With Pain and Signs of Inflammation at Week 24|Change from baseline in number of joints (active joint) with pain and signs of inflammation (tenderness, swelling or effusion) for participants with at least 2 affected joints at baseline were reported. An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion).|Baseline, Week 24|FAS included all the randomized participants who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo. Population included participants with at least 2 affected joints at baseline (2 or more affected joints).|||Joints||Standard Deviation|Mean
2585125|NCT02349061|Secondary|Number of Participants With BILAG-based Combined Lupus Assessment (BICLA) Response at Week 24|BICLA response defined as participants meeting following criteria: 1. BILAG improvement (all BILAG A scores at baseline improved to either B, C or D and all BILAG B scores at baseline improved to C or D and no worsening in disease activity defined as no new BILAG A scores and <= 1 new BILAG B score) and 2. no worsening of total SLEDAI-2K from baseline 3. < 1 cm increase in PGA and 4. no treatment failure criteria met. BILAG: assesses disease extent, severity (range: A [severe] to E [no disease]). SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). PGA: assesses worsening in participant's general health status (0.0= 'no lupus activity' to 10.0 = 'extremely active lupus').|Week 24|FAS included all the randomized participants who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo.|||Participants|||Count of Participants
2585126|NCT02349061|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Score at Week 24|PGA was recorded on a visual analogue scale (VAS; 0.0 to 10.0 centimeter [cm]). The scale for the physician's assessment ranges for 'no lupus activity' (0.0) to 'extremely active lupus' (10.0).|Baseline, Week 24|FAS included all the randomized participants who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2585127|NCT02349061|Secondary|Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI 2K) Score at Week 24|The SLEDAI-2K is an established, validated SLE activity index. It is based on the presence of 24 features in 9 organ systems and measures disease activity in SLE patients in the previous 30 days. It is weighted according to the feature. Features are scored by the assessing physician if present within the last 30 days with more severe features having higher scores, and then simply added to determine the total SLEDAI 2K score, which ranges from 0 to 105, with higher scores representing increased disease activity.|Baseline, Week 24|FAS included all the randomized participants who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2585128|NCT02349061|Primary|Percentage of Participants With a Systemic Lupus Erythematosus Responder Index (SRI-4) Composite Response (CR) at Week 24|SRI-4 response was defined as greater than or equal to 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline in Physician's Global Assessment of Disease Activity (PGA). Composite response is defined as SRI-4 response in participants who do not meet treatment failure criteria. SLEDAI-2K assessment consists of 24 items with total score of 0 to 105, with higher scores representing increased disease activity. BILAG Index: assessing clinical signs, symptoms, or laboratory parameters related to SLE, divided into 9 organ systems. For each organ system: A=severe disease, B=moderate disease, C=mild stable disease, D=inactive, but previously active, E=inactive and never affected. The PGA assess disease activity on a visual analogue scale = from very well (0)-very poor (10).|Week 24|Full analysis set (FAS) included all the randomized participants who received at least 1 dose (partial or complete, IV or SC) of ustekinumab or placebo.|||Percentage of participants|||Number
2585129|NCT02349048|Secondary|Percentage of Participants With or Without an NS3 Q80K Polymorphism at Baseline Achieving SVR|The Q80K polymorphism, associated with low level SMV in vitro resistance. Percentage of participants who achieved SVR with or without an NS3 Q80K polymorphism at baseline were reported.|up to Week 30 for Arm A and Week 32 for Arm B|The ITT analysis set is defined as all enrolled participants who took at least 1 dose of SMV, SOF or DCV. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' signifies number of participants evaluable for this outcome measure at specific time point.|||Percentage of Participants|||Number
2585130|NCT02349048|Secondary|Number of Participants With HCV Nonstructural Protein 3/4A (NS3/4A), NS5A and NS5B Sequence in Participants Not Achieving SVR|Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify preexisting sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR.|Up to Week 30 for Arm A and up to Week 32 for Arm B|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).|||Participants|||Number
2585131|NCT02349048|Secondary|Number of Participants With Late Viral Relapse|Late Viral Relapse: Participant who achieved SVR12 and the post treatment HCV RNA measurement fulfilled 1 the following conditions: a) at least 2 consecutive measurements not lesser than (<)15 IU/mL undetectable, of which at least the second measurement was >=15 IU/mL quantifiable or b) the last available measurement was >=15 IU/mL quantifiable.|From Week 18 to Week 30 (for Arm A), From Week 20 to Week 32 (for Arm B)|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).|||Participants|||Number
2585132|NCT02349048|Secondary|Number of Participants With Viral Relapse|Viral Relapse: Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during followup.|From Week 6 to Week 18 (for Arm A) and From Week 8 to Week 20 (for Arm B)|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).|||Participants|||Number
2585133|NCT02349048|Secondary|Percentage of Participants With On-Treatment Failure|Participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. Includes participants with: 1) viral breakthrough, defined as a confirmed increase of greater than (>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA 2) confirmed detectable HCV RNA at the actual end of treatment (example, completed treatment, discontinued due to adverse events, withdrawal of consent) of >100 IU/mL in participants whose HCV RNA had previously been <LLOQ while on treatment.|Baseline up to End of Treatment (Week 6 for Arm A and Week 8 for Arm B)|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).|||Percentage of Participants|||Number
2585134|NCT02349048|Secondary|Percentage of Participants With Sustained Virologic Response at 4 Weeks (SVR4) and 24 Weeks (SVR24) After End of Study Drug Treatment|Participants were considered to have achieved SVR4 and SVR24 if the HCV RNA was <LLOQ detectable or undetectable at 4 weeks and 24 weeks respectively after the end of study drug treatment. The LLOQ value was 15 IU/mL.|4 weeks after end of study drug treatment (week 10 for Arm A and 12 for Arm B); 24 weeks after end of study drug treatment (week 30 for Arm A and 32 for Arm B)|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).|||Percentage of Participants|||Number
2585135|NCT02349048|Secondary|Percentage of Participants With On-treatment Virologic Response|"On-treatment virologic response was determined by hepatitis C virus (HCV) ribonucleic acid (RNA) results satisfying a specified threshold.~The following thresholds were considered at any time point: <LLOQ undetectable, <LLOQ detectable, and <LLOQ undetectable or detectable. The LLOQ value was 15 IU/mL. Very rapid virologic response (vRVR) is undetectable HCV RNA at Week 2 while on treatment and Rapid virologic response (RVR) is undetectable HCV RNA at Week 4 while on treatment."|Day 2, Day 3, Week 1, 2, 3, 4, 6 (for Arm A) and 8 (for Arm B only)|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV). Here 'n' signifies number of participants who were evaluable at each specified time point, for each arm, respectively.|||Percentage of Participants|||Number
2585136|NCT02349048|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After End of Study Drug Treatment (SVR12)|Participants were considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) was less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the end of study drug treatment.|12 weeks after end of study drug treatment (week 18 for Arm A and week 20 for Arm B)|The Intent-to-treat (ITT) analysis set is defined as all enrolled participants who took at least 1 dose of Simeprevir (SMV), Sofosbuvir (SOF) or Daclatasvir (DCV).|||Percentage of Participants|||Number
2585137|NCT02348918|Primary|Change in BCVA at Week 24|Primary efficacy outcome is BCVA changes at Week 24 as compared to baseline|Value of 24 Weeks minus baseline value||||Letters on ETDRS eye chart||Standard Error|Mean
2585138|NCT02348840|Secondary|Successful Referrals|Referrals to hospitals for further evaluation of possible pregnancy complications were considered to be successful if the pregnant participant went to the hospital after being referred by her TBA. Non-successful referrals were due to the pregnant participant's refusal to go to the hospital (due to lack of permission from a family member, fear, or not recognizing the complication as an emergency) or due to logistical difficulties.|Month 7, Month 12|There were a different number of referrals made during each study period; the overall number analyzed represents the maximum count of referrals in a study period for that study arm.|||Referrals to hospital|Referrals made during the study period||Number
2585139|NCT02348840|Primary|Number of Neonatal Deaths|The number of neonatal deaths during the entire study period are presented. Baseline complication rates were unknown for this study population and the study was not powered to detect a difference in the rate of any complication (including neonatal deaths), thus only the total deaths during the entire 12 month period are included.|Month 12|All pregnant participants are included in this analysis.|||deaths|||Number
2585314|NCT02347085|Secondary|Morning Pre-Dose Trough FEV1 on Day 30|Morning Pre-Dose Trough FEV1 on Day 30|Day 30|MITT Population|||Liters||95% Confidence Interval|Mean
2585142|NCT02348723|Secondary|Incidence of Minor Bleeding Events|"Minor bleeds were clinical bleeds that did not fulfil the criteria for major bleeds. Percentage of patients with Minor bleeding events are presented.~These are based on adjudicated data (blinded evaluation)"|during and up to 2 months post-ablation|AS|||percentage of participants|||Number
2585143|NCT02348723|Secondary|Incidence of the Composite of Stroke, Systemic Embolism, or Transient Ischemic Attack (TIA)|"Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction.~Systemic embolism was defined as an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and was to be documented by angiography, surgery, scintigraphy or autopsy.~Transient ischemic attack was defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction.~These are based on adjudicated data (blinded evaluation).~Percentage of patients with composite of stroke, systemic embolism, or transient ischemic attack (TIA) is presented"|during and up to 2 months post-ablation|AS|||percentage of participants|||Number
2585144|NCT02348723|Primary|Incidence of Major Bleeding Events (MBEs), as Defined by the International Society on Thrombosis and Haemostasis (ISTH)|"Major bleeds were defined according to the ISTH definition of a major bleed, as follows~Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or~Bleeding associated with a reduction in haemoglobin of at least 2 g/dL (1.24 mmol/L), or leading to transfusion of 2 or more units of blood or packed cells. and/or~Fatal bleed~These are based on adjudicated data (blinded evaluation)~Point estimates for the incidence of ISTH MBEs and their 2-sided 95% confidence intervals (CI), based on the normal approximation of independent binomial distribution without stratification, are presented."|during and up to 2 months post-ablation|The ablation set (AS) was the primary analysis set and included all patients in the treated set (TS) who started the ablation procedure|||percentage of participants||95% Confidence Interval|Number
2585145|NCT02348684|Other Pre-specified|Dose-volume Constraints for the Heart During Radiation Therapy for Breast Cancer.|Trial data will improve the understanding of cardiac function after radiotherapy and allow oncologists to start to define safe dose-volume constraints for the heart in women treated with regional nodal irradiation for breast cancer.|The day of the MRI||2020-07-31|07/2020||||
2585146|NCT02348684|Secondary|Correlate Cardiac MRI Parameters|Correlate cardiac MRI parameters with pre-treatment heart imaging and cardiac dose volume constraints as a measure of cardiac injury after partial heart irradiation in women with node positive breast cancer treated with surgery, anthracycline-based chemotherapy and regional nodal irradiation.|the day of MRI||2020-07-31|07/2020||||
2585147|NCT02348684|Primary|Cardiac MRI Parameters|Cardiac MRI parameters include Left Ventricular (LV) ejection fraction, LV mass (indexed), LV dimensions, extracellular volume (ECV), and late gadolinium enhancement (LGE).|day of MRI scan||||number of patients|||Number
2585148|NCT02348658|Secondary|Number of Participants With Clinical Significant Findings in Electrocardiograms After Study Drug Administration|Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measurement.|Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.|||participants|||Number
2585149|NCT02348658|Secondary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Laboratory Values||Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.|||participants|||Number
2585150|NCT02348658|Secondary|Number of Participants With TEAEs Related to Body Weight||Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.|||participants|||Number
2585151|NCT02348658|Secondary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.|||participants|||Number
2585152|NCT02348658|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)||Baseline up to 14 days after last dose of study drug (14 days after Day 1 of Period 2 )|Safety analysis set included all participants who received the study drug.|||participants|||Number
2585153|NCT02348658|Primary|Urinary Excretion Ratio of AML|Urinary excretion ratio (% of dose) of AML in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.|Day 1: predose and at multiple time-points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||percentage of dose|||Number
2585154|NCT02348658|Primary|Urinary Excretion Ratio of TAK-536, Its Metabolites (M-I and M-II) and HCTZ|Urinary excretion ratio (percent [%] of dose) of TAK-536, its metabolite M-I, M-II and HCTZ in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected in each pooling period.|Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||percentage of dose|||Number
2585155|NCT02348658|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for AML|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Day 1: predose and at multiple time points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||ng*hr/mL||Standard Deviation|Mean
2585193|NCT02348203|Secondary|Changes in the Metabolomics Profile of the Arachidonic Acid Pathway|Two sample t tests will be performed to evaluate whether or not there are significant differences in changes in oxylipin metabolome between the treatment and placebo groups. In addition, system biology methods will also be used to analyze the oxylipin metabolome data.|Baseline to week 12|||||||
2585156|NCT02348658|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Day 1: predose and at multiple time points (up to 48 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||ng*hr/mL||Standard Deviation|Mean
2585157|NCT02348658|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for AML|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1: predose and at multiple time points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||ng*hr/mL||Standard Deviation|Mean
2585158|NCT02348658|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ|AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1: predose and at multiple time points (up to 48 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||ng*hr/mL||Standard Deviation|Mean
2585159|NCT02348658|Primary|AUC(0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours Postdose in Each Period for AML|AUC(0-120) is a measure of the area under the plasma concentration time-curve from time 0 to 120 hours postdose.|Day 1: predose and at multiple time points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||ng*hr/mL||Standard Deviation|Mean
2585160|NCT02348658|Primary|AUC(0-48): Area Under the Plasma Concentration-Time Curve From Time 0 to 48 Hours Postdose in Each Period for TAK-536, Its Metabolites (M-I and M-II) and HCTZ|AUC(0-48) is a measure of the area under the plasma concentration time-curve from time 0 to 48 hours postdose.|Day 1: predose and at multiple time points (up to 48 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
2585161|NCT02348658|Primary|Cmax: Maximum Plasma Concentration for Amlodipine Besilate (AML)||Day 1: predose and at multiple time points (up to 120 hours) postdose in each period|PK analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||ng/mL||Standard Deviation|Mean
2585162|NCT02348658|Primary|Cmax: Maximum Plasma Concentration for TAK-536, Its Metabolites (M-I and M-II) and Hydrochlorothiazide (HCTZ)||Day 1: predose and at multiple time points (up to 48 hours) postdose in each period|Pharmacokinetic (PK) analysis set included all participants who received the study drug, completed the minimum protocol-specified procedures without any major protocol deviations, and who were evaluable for the food-effect.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2585163|NCT02348632|Secondary|Subjects Reported as Worse on the Clinical Global Impression of Change (CGIc)|Subjects reported as worse (very much worse, much worse, and minimally worse) on the CGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline.|Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)|282 subjects were randomized into the randomized withdrawal period. Two subjects who were treated in the randomized withdrawal period did not have evaluable efficacy data during that period. Therefore, the mITT Population comprised 280 subjects, 141 who received placebo and 139 who received JZP-110.|||percentage of subjects|||Number
2585164|NCT02348632|Secondary|Subjects Reported as Worse on the Patient Global Impression of Change (PGIc)|Percentage of subjects reported as worse (minimally worse, much worse, or very much worse) on the PGIc during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline.|Beginning of randomized withdrawal phase to end of the randomized withdrawal phase (2 weeks)|282 subjects were randomized into the randomized withdrawal period. Two subjects who were treated in the randomized withdrawal period did not have evaluable efficacy data during that period. Therefore, the mITT Population comprised 280 subjects, 141 who received placebo and 139 who received JZP-110.|||percentage of subjects|||Number
2585165|NCT02348632|Primary|Change in Epworth Sleepiness Scale (ESS) Score|"Change in Epworth Sleepiness Scale (ESS) score during the 2-week randomized withdrawal period. The beginning of the randomized withdrawal period represents efficacy baseline. A negative change from baseline represents improvement in excessive sleepiness.~The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. This analysis included treatment group and randomization stratification factor (narcolepsy vs. OSA) as fixed effects. The ESS score at the beginning of the randomized withdrawal period was used as the covariate. The response variable was the change in ESS score from the beginning to the end of 2- week randomized withdrawal period."|Start of randomized withdrawal phase to end of randomized withdrawal (2 weeks)|282 subjects were randomized into the randomized withdrawal period. Two subjects who were treated in the randomized withdrawal period did not have evaluable efficacy data during that period. Therefore, the mITT Population comprised 280 subjects, 141 who received placebo and 139 who received JZP-110.|||points on a scale||Standard Error|Least Squares Mean
2585194|NCT02348203|Secondary|Gender Effect on Smoking-related Gene Expression Signature|Exploratory analyses will be performed to evaluate whether the effect of ASA and zileuton on smoking-related gene expression signature is modulated by gender.|Up to week 12|||||||
2585315|NCT02347085|Secondary|Morning Pre-Dose Trough FEV1 on Day 29|Morning Pre-Dose Trough FEV on Day 29|Day 29|MITT Population|||Liters||95% Confidence Interval|Mean
2585166|NCT02348619|Secondary|Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10)|Change is total score from the end of the stable dose phase to the end of the double blind withdrawal phase. Functional Outcomes of Sleep Questionnaire Short Version (FOSQ-10) is a 10-item disease-specific quality of life questionnaire to assess the effect of excessiveness sleepiness on multiple activities of everyday living. The FOSQ-10 consists of 10 questions, each scored on a scale from 1-4. The questionnaire has a 4-point response format for each question (1 = extreme difficulty, 2 = moderate difficulty, 3 = a little difficulty, and 4 = no difficulty). The total score is derived by the mean of the 5 subscale scores, multiplied by 5, resulting in a possible range of scores between 5 to 20; lower FOSQ-10 scores are worse, indicating more difficulty carrying out activities; higher FOSQ-10 scores are better, indicating less difficulty carrying out activities.|Week 4 to Week 6||||units on a scale||Standard Error|Least Squares Mean
2585167|NCT02348619|Secondary|Clinical Global Impression of Change (CGIc)|Percentage of subjects reported as worse (minimally, much, or very much) on the CGIc at the end of the Double-blind Withdrawal Phase. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.|Week 4 to Week 6||||percentage of subjects|||Number
2585168|NCT02348619|Secondary|Patient Global Impression of Change (PGIc)|Percentage of subjects reported as worse (minimally, much, or very much) on the PGIc at the end of the Double-blind Withdrawal Phase. PGIc was rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.|Week 4 to Week 6||||percentage of subjects|||Number
2585169|NCT02348619|Primary|Change in the Epworth Sleepiness Scale (ESS)|"Change in Epworth Sleepiness Scale (ESS) score from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. A negative change from baseline represents improvement in excessive sleepiness.~The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from week 4 to week 6."|Week 4 to Week 6||||points on a scale||Standard Error|Least Squares Mean
2585170|NCT02348619|Primary|Change in the Maintenance of Wakefulness Test (MWT)|Change in the mean sleep latency time as determined from the first four trials of a 40-minute MWT from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. Mean sleep latency defined as the average of the first four MWT trial's measurements.|Week 4 to Week 6||||minutes||Standard Error|Least Squares Mean
2585171|NCT02348606|Secondary|Percentage of Subjects Reported as Improved on the CGIc at Week 1, Week 4, and Week 8|Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 1, Week 4, and Week 8. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.|Weeks 1, 4, and 8|Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.|||percentage of subjects|||Number
2585172|NCT02348606|Secondary|Percentage of Subjects Reported as Improved on the Clinical Global Impression of Change (CGIc) at Week 12|Percentage of subjects reported as improved (minimally, much, or very much) on the CGIc at Week 12. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.|Week 12|Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.|||percentage of subjects|||Number
2585173|NCT02348606|Secondary|Percentage of Subjects Reported as Improved on the PGIc at Week 1, Week 4, and Week 8|Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 1, Week 4, and Week 8. PGIc was rated by subjects and measures the change in their condition since treatment start on a 7-point scale ranging from 1 = very much improved to 7 = very much worse.|Weeks 1, 4, and 8|Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.|||percentage of subjects|||Number
2585174|NCT02348606|Secondary|Change in ESS Score From Baseline to Week 1, Week 4, and Week 8|"Change in Epworth Sleepiness Scale (ESS) score from Baseline to Weeks 1, 4, and 8. A negative change from baseline represents improvement in excessive sleepiness.~The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline."|Baseline to Weeks 1, 4, and 8||||points on a scale||Standard Error|Least Squares Mean
2585175|NCT02348606|Secondary|Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-minute MWT From Baseline to Week 4|Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to week 4.|Baseline to Week 4|Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.|||minutes||Standard Error|Least Squares Mean
2585176|NCT02348606|Secondary|Change in Sleep Latency Time on Each of the 5 MWT Trials at Week 12|Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at week 12.|Baseline and Week 12|Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.|||minutes||Standard Error|Least Squares Mean
2585177|NCT02348606|Secondary|Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12|"Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12. PGIc was rated by subjects and measures the change in their condition since start of treatment on a 7-point scale ranging from 1 = very much improved to 7 = very much worse.~This is the key secondary endpoint."|12 Weeks|Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.|||percentage of subjects|||Number
2585195|NCT02348203|Secondary|Incidence of Adverse Events Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Descriptive statistics of the type and frequency of all adverse events will be generated, including 95% confidence intervals. For each type of the adverse events, a Fisher's exact test will be performed to compare the frequency of the adverse event between the two groups.|Up to 2 weeks post-treatment|||||||
2585178|NCT02348606|Primary|Change in ESS Score From Baseline to Week 12|"Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. A negative change from baseline represents improvement in excessive sleepiness.~The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline."|Baseline to Week 12|Fifteen subjects in the Safety Population were excluded from the mITT Population resulting in a total of 459 subjects.|||points on a scale||Standard Error|Least Squares Mean
2585179|NCT02348606|Primary|Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12|Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12.|Baseline to Week 12|Fifteen subjects in the Safety Population were excluded from the Modified Intent-to Treat (mITT) Population resulting in a total of 459 subjects.|||minutes||Standard Error|Least Squares Mean
2585180|NCT02348593|Secondary|Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-Minute MWT From Baseline to Week 4|Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from Baseline to Week 4.|Baseline to Week 4|Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.|||minutes||Standard Error|Least Squares Mean
2585181|NCT02348593|Secondary|Change in Sleep Latency Time on MWT Trial 5 at Week 12|Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.|Change from baseline for sleep latency in MWT during trial 5 at week 12|Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.|||minutes||Standard Error|Least Squares Mean
2585182|NCT02348593|Secondary|Change in Sleep Latency Time on MWT Trial 4 at Week 12|Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.|Change from baseline for sleep latency in MWT during trial 4 at week 12|Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.|||minutes||Standard Error|Least Squares Mean
2585183|NCT02348593|Secondary|Change in Sleep Latency Time on MWT Trial 3 at Week 12|Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.|Change from baseline for sleep latency in MWT during trial 3 at week 12|Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.|||minutes||Standard Error|Least Squares Mean
2585184|NCT02348593|Secondary|Change in Sleep Latency Time on MWT Trial 2 at Week 12|Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.|Change from baseline for sleep latency in MWT during trial 2 at week 12|Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.|||minutes||Standard Error|Least Squares Mean
2585185|NCT02348593|Secondary|Change in Sleep Latency Time on MWT Trial 1 at Week 12|Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.|Change from baseline for sleep latency in MWT during trial 1 at week 12|Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.|||minutes||Standard Error|Least Squares Mean
2585186|NCT02348593|Secondary|Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12|Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12. PGIc was rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse|Baseline to Week 12|Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.|||percentage of subjects|||Number
2585187|NCT02348593|Primary|Change in ESS Score From Baseline to Week 12|"Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. A negative change from baseline represents improvement in excessive sleepiness.~The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline."|Baseline to Week 12|Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.|||points on a scale||Standard Error|Least Squares Mean
2585188|NCT02348593|Primary|Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12|Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake; a positive change from baseline represents improvement in the sleep latency time. Mean sleep latency defined as the average of the first 4 MWT trials, if 3 or 4 of them are non-missing.|Baseline to Week 12|Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.|||minutes||Standard Error|Least Squares Mean
2585189|NCT02348385|Primary|Percent Change in Binding Potential of Dopamine Release During PET Scan Post Amphetamine Administration|Percent change in binding potential of dopamine release during PET scan post amphetamine administration.Binding potential (BP) is the PET neuroimaging outcome measure that is computed as a proxy for availability of dopamine D2/3 receptors in a given region-of-interest.|After 2 PET Scans (1 day)||||percentage change in binding potential||Standard Deviation|Mean
2585190|NCT02348359|Primary|Mean Change in Visual Acuity Score From Day -1 to Week52|The primary outcome is the change in the visual acuity score from Day -1 to 52 weeks after randomization.|Week 52|Analysis restricted to subjects who completed 52 weeks of treatment|||number of letters||Standard Deviation|Mean
2585191|NCT02348203|Secondary|Impact of ASA and Zileuton on Karyometric Analysis of Buccal Cells||Up to week 12|||||||
2585192|NCT02348203|Secondary|Whole-genome Gene Expression|Pair-wise comparisons based on two-sample t tests will be performed to whole-genome gene expression data to identify the genes for which ASA and zileuton has a significantly different expression level from the placebo group. Multivariate statistical techniques such as principle component analysis (PCA) will be used to reduce complexity of the whole-genome expression data.|Up to week 12|||||||
2585200|NCT02348203|Secondary|Impact of ASA and Zileuton on Three Lung Cancer Gene Signatures (an 80-gene Bronchial Signature, a PI3K Pathway Gene Signature and a Nasal Diagnostic Gene Signature)|Analysis of variance will be performed to evaluate whether ASA and zileuton has significantly different impact on changes in the three lung cancer gene signatures and the changes are significantly different from the placebo group.|Up to week 12|||||||
2585201|NCT02348203|Primary|Changes in a Smoking-related Gene Expression Signature Score in the Nasal Epithelium of Current Smokers After Acetylsalicylic Acid (ASA) and Zileuton Intervention|Change in a nasal smoking-related gene expression signature score derived from prior research was compared between the two study arms. Prior research showed that a higher score was observed in never smokers compared to current smokers. An increased score implicated a more favorable intervention effect. There is no minimum or maximum score.|Baseline to 12 weeks (End-of-intervention)||||score on a scale||Standard Deviation|Mean
2585202|NCT02347943|Primary|Number of Participants Completing Follow-Up Visits||2 years|Due to early cancellation of the study data for this endpoint were not collected.||||||
2585203|NCT02347787|Secondary|Hospital Admission - Mean Length of Stay (Among Participants With Hospitalization)|We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record|6 months and 9 months|This outcome was only assessed for participants who had a hospital admission. Therefore the number of participants analyzed is smaller than that for the overall study.|||days||Standard Deviation|Mean
2585204|NCT02347787|Secondary|Hospital Admission - Mean Number of Hospitalizations|We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record|6 months and 9 months|This outcome was only assessed for participants who had a hospital admission. Therefore the number of participants analyzed is smaller than that for the overall study.|||Hospitalizations||Standard Deviation|Mean
2585205|NCT02347787|Secondary|Hospital Admission - Total Hospital Days|We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record|6 months and 9 months||||Days|||Number
2585206|NCT02347787|Secondary|Number of Participants With 30 Day Hospital Readmissions|We will measure admission to hospital at 30 days after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record|30 days|This outcome was only assessed for participants who had hospital admission. Therefore the number of participants analyzed is smaller than that for the overall study.|||Participants|||Count of Participants
2585207|NCT02347787|Secondary|Number of Participants With Multiple Hospital Admissions|We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record|6 months and 9 months|This outcome was only assessed for participants who had hospital admission. Therefore the number of participants analyzed is smaller than that for the overall study.|||Participants|||Count of Participants
2585208|NCT02347787|Secondary|Number of Participants Reporting the Highest Rating for Quality of Patient-centered Care - Supportiveness of Self-management|We will assess this outcome using the Consumer Assessment of Healthcare Providers and Systems Patient-Centered Medical Home (CAHPS PCMH) survey. This survey assesses the quality of patient-centered primary care and can be used by any practice (not just PCMH practices). We will measure the CAHPS PCMH domains pertaining to Self-Management Support and Comprehensiveness of Care. We will measure the number of patients who gave the highest rating of care for the supportiveness of disease self-management question at 6 and 9 months post-enrollment.|6 months, 9 months||||Participants|||Count of Participants
2585209|NCT02347787|Secondary|Qualitative Assessment of Intervention and Mechanisms Affecting Achievement of Primary Outcome|At 6-months post-enrollment, a trained qualitative interviewer on our study team will conduct an in-depth qualitative semi-structured interview with 40 intervention arm patients and their CHWs. Qualitative interviews will be audio-taped and transcribed. Patients will be purposively sampled across each study site in order to be able to make comparisons between those who achieved a minimally important improvement in the primary outcome and those who did not. These interviews will be guided by the Integrative Behavior Model (IBM). UPDATE: After beginning interviews, our team decided that 26 interviews was sufficient to reach thematic saturation.|6 months|This data point contains qualitative, not quantitative data. The study team is still analyzing this data set and has not yet completed analysis for this outcome. Below, we report the number of interviews completed for each clinical site (VA, Federally Qualified Health Center, Academic Site). We will not complete any more interviews.|||Participants|||Count of Participants
2585210|NCT02347787|Secondary|Number of Participants With Any Hospital Admission|We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record|6 months and 9 months||||Participants|||Count of Participants
2585211|NCT02347787|Secondary|Number of Participants Reporting Highest Rating for Quality of Patient-centered Care - Comprehensiveness|We will assess this outcome using the Consumer Assessment of Healthcare Providers and Systems Patient-Centered Medical Home (CAHPS PCMH) survey. This survey assesses the quality of patient-centered primary care and can be used by any practice (not just PCMH practices). We will measure the CAHPS PCMH domains pertaining to Self-Management Support and Comprehensiveness of Care. We will measure the number of patients who gave the highest rating of care for the comprehensiveness question at 6 and 9 months post-enrollment.|6 months, 9 months||||Participants|||Count of Participants
2585212|NCT02347787|Secondary|Short Form Health Survey (SF-12) - Mental Component Summary (MCS)|The SF-12 is a survey designed for use with patients with multiple chronic conditions. This 12-item scale can be used to assess the physical and mental health of respondents. 10 of the 12 questions are answered on a 5 point likert scale and 2 are answered on a 3 point likert scale. The questions are then scored and weighted into 2 subscales, physical health and mental health. Respondents can have a score that ranges from 0-100 with 100 being the best score and indicating high physical or mental health. A 3 point change in SF-12 score reflects a meaningful difference. We will assess this outcome using the SF-12 Mental Component Summary (MCS) score. The MCS reliably detects differences in mental health over time. We will measure the between-arm difference in mean change in SF-12 MCS score between baseline, 6- and 9- month follow-up.|Baseline, 6 months, 9 months||||score on a scale||Standard Deviation|Mean
2585213|NCT02347787|Secondary|Change in Chronic Disease Control - Hypertension|We will asses change in chronic disease control using biometric testing (systolic blood pressure in mm Hg). At six and nine months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest.|Baseline, 6 months, 9 months|Each participant was only analyzed for their chosen chronic condition.|||mm Hg||Standard Deviation|Mean
2585214|NCT02347787|Secondary|Change in Chronic Disease Control - Tobacco Use|We will asses change in chronic disease control using patient self-report (cigarettes per day). At six and nine months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest.|Baseline, 6 months, 9 months|Each participant was only analyzed for their chosen chronic condition.|||cigarettes per day||Standard Deviation|Mean
2585215|NCT02347787|Secondary|Change in Chronic Disease Control - Obesity|We will asses change in chronic disease control using biometric testing (kg/m^2). At six and nine months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing: height and weight. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest.|Baseline, 6 months, 9 months|Each participant was only analyzed for their chosen chronic condition.|||kg/m^2 (BMI)||Standard Deviation|Mean
2585216|NCT02347787|Secondary|Change in Chronic Disease Control - Diabetes|We will asses change in chronic disease control using biometric testing (HgA1c). At six months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing: HgbA1c. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest.|Baseline, 6 months, 9 months|Each participant was only analyzed for their chosen chronic condition.|||HbA1c%||Standard Deviation|Mean
2585217|NCT02347787|Primary|Short Form Health Survey (SF-12) Physical Component Score (PCS)|The main dependent variable is mean change in standardized score for SF-12 PCS. The SF-12 is a survey designed for use with patients with multiple chronic conditions. This 12-item scale can be used to assess the physical and mental health of respondents. 10 of the 12 questions are answered on a 5 point likert scale and 2 are answered on a 3 point likert scale. The questions are then scored and weighted into 2 subscales, physical health and mental health. Respondents can have a score that ranges from 0-100 with 100 being the best score and indicating high physical or mental health. A 3 point change in SF-12 score reflects a meaningful difference. We measure the between-arm difference in mean change in SF-12 PCS between baseline and 6-month follow-up assessment.|Baseline, 6 months||||score on a scale||Standard Deviation|Mean
2585218|NCT02347774|Secondary|Incidence Rate Per 1000 Person-years of Subjects With Major Adverse Cardiac Events (MACE)|"All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs myocardial infarction, other ischemic heart disease, central nervous system hemorrhages and cerebrovascular conditions) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)~Incidence rate: TT= Total Time in years. Total Time (TT) is defined as the time from the first date of study drug until the latter of the date of last contact or 30 days after the date of last dose. Incidence Rate (per 1000 person-years) = n/TT x 1000."|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.One subject randomized in error to the placebo arm was never dosed .|||incidence rate|||Number
2585219|NCT02347774|Secondary|Percentage of Subjects With Major Adverse Cardiac Events (MACE)|"All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs myocardial infarction, other ischemic heart disease, central nervous system hemorrhages and cerebrovascular conditions) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)"|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.One subject randomized in error to the placebo arm was never dosed .|||percentage of participants|||Number
2585220|NCT02347774|Secondary|Number of Subjects With Major Adverse Cardiac Events (MACE)|"All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs myocardial infarction, other ischemic heart disease, central nervous system hemorrhages and cerebrovascular conditions) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)"|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. One subject randomized in error to the placebo arm was never dosed .|||Participants|||Count of Participants
2585316|NCT02347085|Secondary|Peak Change From Baseline in FEV1 on Day 29|Peak Change From Baseline in FEV1 following the morning dose on Day 29|Day 29|MITT Population|||Liters||95% Confidence Interval|Mean
2585221|NCT02347774|Secondary|Percentage of Subjects Who Discontinue Treatment Due to TEAE|A TEAE is defined as any AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. One subject randomized in error to the placebo arm was never dosed .|||percentage of participants|||Number
2585222|NCT02347774|Secondary|Number of Subjects Who Discontinue Treatment Due to TEAE|A TEAE is defined as any AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. One subject randomized in error to the placebo arm was never dosed .|||Participants|||Count of Participants
2585223|NCT02347774|Secondary|Percentage of Subjects With Treatment Emergent Serious Adverse Events (SAE)|A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. One subject randomized in error to the placebo arm was never dosed .|||percentage of participants|||Number
2585224|NCT02347774|Secondary|Number of Subjects With Treatment Emergent Serious Adverse Events (SAE)|A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. One subject randomized in error to the placebo arm was never dosed .|||Participants|||Count of Participants
2585225|NCT02347774|Secondary|Percentage of Subjects With Treatment Emergent Adverse Events (TEAE)|A TEAE is defined as any non-serious AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication. One subject randomized in error to the placebo arm was never dosed .|||percentage of participants|||Number
2585226|NCT02347774|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAE)|On-treatment A TEAE is defined as any non-serious AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.One subject randomized in error to the placebo arm was never dosed .|||Participants|||Count of Participants
2585227|NCT02347774|Secondary|Change in Number of Rescue Medication Puffs Per Day Over the 12-week Double-blind Treatment Period|"All collected Participants completed an electronic diary (eDiary) daily (night time) to record the number of puffs of rescue medication inhaled in the previous 24 hours. A negative change from baseline indicates improvement.~All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not. Values not collected remained as missing values and were assumed to be missing at random (MAR)."|Week 0-12|"Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study One subject randomized in error to the placebo arm was never dosed .~medication. Subjects were analyzed based on the treatment they were randomized to.One subject randomized in error to the placebo arm was never dosed ."|||puffs (medication used)||Standard Error|Least Squares Mean
2585228|NCT02347774|Secondary|Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) Week 12/End of Study|"On-treatment Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: symptoms, activity, and impacts. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is 0 and the highest 100. Higher values correspond to greater impairment of health status.~Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR)."|baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.One subject randomized in error to the placebo arm was never dosed .|||units on a scale||Standard Error|Least Squares Mean
2585229|NCT02347774|Secondary|Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) at Week 12/End of Study|"All collected Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: symptoms, activity, and impacts. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is 0 and the highest 100. Higher values correspond to greater impairment of health status.~All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not. Values not collected remained as missing values and were assumed to be missing at random (MAR)."|baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.One subject randomized in error to the placebo arm was never dosed .|||units on a scale||Standard Error|Least Squares Mean
2585317|NCT02347085|Secondary|Peak Change From Baseline in FEV1 on Day 29|Peak Change From Baseline in FEV1 following evening Dose on Day 29|Day 29|MITT Population|||Liters||95% Confidence Interval|Mean
2585318|NCT02347085|Secondary|FEV1 AUC0-12 on Day 29|FEV1 AUC0-12 on Day 29|Day 29|MITT Population|||Liters||95% Confidence Interval|Mean
2585230|NCT02347774|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC)Week 12|"On-treatment Spirometry was performed according to internationally accepted standards. Trough FVC at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.~Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR)."|baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to. One subject randomized in error to the placebo arm was never dosed .|||liters||Standard Error|Least Squares Mean
2585231|NCT02347774|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 12|"All collected Spirometry was performed according to internationally accepted standards. Trough FVC at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.~All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR)."|baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to. One subject randomized in error to the placebo arm was never dosed .|||liters||Standard Error|Least Squares Mean
2585232|NCT02347774|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) Week 12|"On-treatment Spirometry was performed according to internationally accepted standards. Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.~Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR)."|Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
2585233|NCT02347774|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12|"All collected Spirometry was performed according to internationally accepted standards. Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.~All collected values were used in this analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR)."|baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.One subject randomized in error to the placebo arm was never dosed .|||liters||Standard Error|Least Squares Mean
2585234|NCT02347761|Secondary|Incidence Rate Per 100 Person-years of Subjects With Treatment Emergent Adverse Events (TEAE)|"ALL COLLECTED All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs myocardial infarction, other ischemic heart disease, central nervous system hemorrhages and cerebrovascular conditions) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)I ncidence rate: TT= Total Time in years. Total Time (TT) is defined as the time from the first date of study drug until the latter of the date of last contact or 30 days after the date of last dose. Incidence Rate (per 1000 person-years) = n/TT x 1000."|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||events per 100 person-years|||Number
2585235|NCT02347761|Secondary|Percent of Subjects Who Discontinue Treatment Due to TEAE|ON TREATMENT A TEAE is defined as any AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study meidcation|||percentage of participants|||Number
2585236|NCT02347761|Secondary|Number of Subjects Who Discontinue Treatment Due to TEAE|ON TREATMENT A TEAE is defined as any AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study meidcation|||participants|||Number
2585237|NCT02347761|Secondary|Percent of Subjects With Treatment Emergent Serious Adverse Events (SAE)|ON TREATMENT A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication|||percentage of participants|||Number
2585238|NCT02347761|Secondary|Number of Subjects With Treatment Emergent Serious Adverse Events (SAE)|ON TREATMENT A treatment emergent SAE is defined as any SAE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent SAE is an on-treatment SAE|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication|||participants|||Number
2585319|NCT02347085|Secondary|FEV1 AUC12-24 on Day 29|FEV1 AUC12-24 on Day 29|Day 29|MITT Population|||Liters||95% Confidence Interval|Mean
2585239|NCT02347761|Secondary|Percent of Subjects With Treatment Emergent Adverse Events (TEAE)|ON TREATMENT A TEAE is defined as any non-serious AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||percentage of participants|||Number
2585240|NCT02347761|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAE)|ON TREATMENT A TEAE is defined as any non-serious AE that occurred on or after the first dose of study medication and within 7 days after the last dose of study medication, or any serious AE that occurred on or after the first dose of study medication and within 30 days after the last dose of study medication. A treatment emergent AE is an on-treatment AE.|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||participants|||Number
2585241|NCT02347761|Secondary|Percentage of Subjects With Major Cardiac Events (MACE)|"ALL COLLECTED All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs myocardial infarction, other ischemic heart disease, central nervous system hemorrhages and cerebrovascular conditions) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)"|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||percentage of participants|||Number
2585242|NCT02347761|Secondary|Number of Subjects With Major Adverse Cardiac Events (MACE)|"ALL COLLECTED All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs myocardial infarction, other ischemic heart disease, central nervous system hemorrhages and cerebrovascular conditions) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected for the double-blind period (from the first date of study medication until the date of last contact)"|Week 0-12|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||participants|||Number
2585243|NCT02347761|Secondary|Change in Number of Rescue Medication Puffs Per Day Over the 12-week Double-blind Treatment Period|"ALL COLLECTED Participants completed an electronic diary (eDiary) daily (night time) to record the number of puffs of rescue medication inhaled in the previous 24 hours. A negative change from baseline indicates improvement.~All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not. Values not collected remained as missing values and were assumed to be missing at random (MAR)."|Week 0-12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.|||puffs (medication used)||Standard Error|Least Squares Mean
2585244|NCT02347761|Secondary|Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) Week 12/End of Study|"ON TREATMENT Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: symptoms, activity, and impacts. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is 0 and the highest 100. Higher values correspond to greater impairment of health status.~Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR)."|Baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.|||scores on a scale||Standard Error|Least Squares Mean
2585245|NCT02347761|Secondary|Change From Baseline in Health Status Measured by St. George's Respiratory Questionnaire (SGRQ) at Week 12/End of Study|"ALL COLLECTED Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: symptoms, activity, and impacts. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is 0 and the highest 100. Higher values correspond to greater impairment of health status.~All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not. Values not collected remained as missing values and were assumed to be missing at random (MAR)."|Baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.|||scores on a scale||Standard Error|Least Squares Mean
2585246|NCT02347761|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) Week 12|ON TREATMENT Spirometry was performed according to internationally accepted standards. Trough FVC at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose. Change from baseline in trough FVC was calculated as the trough FVC value at Week 12 minus the morning trough FVC at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose).Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).|Baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
2585320|NCT02347085|Primary|FEV1 AUC0-24 on Day 29|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC)0-24 on Day 29|Day 29|Modified-Intent-to-Treat (MITT) Population|||Liters||95% Confidence Interval|Mean
2585247|NCT02347761|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 12|"ALL COLLECTED Spirometry was performed according to internationally accepted standards. Trough FVC at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.~All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random"|Baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
2585248|NCT02347761|Secondary|Standardized Change From Baseline at Week 12 in FEV1 Area Under the Curve (AUC) (0-12) in Substudy Population|ON TREATMENT The standardized FEV1 AUC(0-12) was calculated at weeks 0 and 12 for the Substudy Population with extended spirometry measurements. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time. Intermittent missing spirometry measurements were ignored and the trapezoidal rule would simply span the missing time points. If the Hour 12 time point was missing, then the AUC(0-12) calculation was based on the time interval up to the last non-missing time point prior to Hour 12. If a subject has a missing baseline FEV1, then that subject had a missing AUC.Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).|Baseline and Week 12|The Substudy Population consisted of all ITT subjects who participated in post-dose serial measurements, including serial spirometry, serial ECGs, serial vital sign measurements, as well as Holter monitoring at Visit 6.|||liters||Standard Error|Least Squares Mean
2585249|NCT02347761|Secondary|Standardized Change From Baseline at Week 12 in FEV1 Area Under the Curve (AUC) (0-12) in the Substudy Population|ALL COLLECTED The standardized FEV1 AUC(0-12) was calculated at weeks 0 and 12 for the Substudy Population with extended spirometry measurements. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time. Intermittent missing spirometry measurements were ignored and the trapezoidal rule would simply span the missing time point(s). If the Hour 12 time point was missing, then the AUC(0-12) calculation was based on the time interval up to the last non-missing time point prior to Hour 12. If a subject has a missing baseline FEV1, then that subject had a missing AUC. All collected values were used in the analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR).|Baseline and Week 12|The Substudy Population consisted of all ITT subjects who participated in post-dose serial measurements|||liters||Standard Error|Least Squares Mean
2585250|NCT02347761|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) Week 12|ON TEATMENT-Spirometry was performed according to internationally accepted standards.Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.Change from baseline in trough FEV1 was calculated as the trough FEV1 value at Week 12 minus the morning trough FEV1 at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose).Only on-treatment values (which included only data collected while subjects were taking study drug) are used for this analysis. Values affected by other medication use were set to missing. Non-collected or missing data were not imputed for this analysis. Values not collected remained as missing values and were assumed to be missing at random (MAR).|Baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
2585251|NCT02347761|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12|"ALL COLLECTED-Spirometry was performed according to internationally accepted standards.Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.Change from baseline in trough FEV1 was calculated as the trough FEV1 value at Week 12 minus the morning trough FEV1 at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose). All collected values were used in this analyses, regardless if the subject remained on randomized treatment or not, and regardless if the values might potentially be affected by other therapies or not Values not collected remained as missing values and were assumed to be missing at random (MAR) ALL COLLECTED and ON TREATMENT data are the same. The only difference is in the number of visits included for those participants who may have discontinued randomized treatment but remained in the study. for all endpoints"|Baseline and Week 12|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
2585252|NCT02347657|Secondary|Trough Plasma Concentrations (Ctrough) of VX-661, VX-661 Metabolites (M1 VX-661 and M2-VX-661), Ivacaftor (IVA) and IVA Metabolite (M1-IVA)|This outcome was not planned to be assessed in Placebo arm.|Pre-morning dose on Week 16|Pharmacokinetic (PK) set included all randomized participants who received any amount of study drug and had a PK assessment. Here 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2585253|NCT02347657|Secondary|Absolute Change From Baseline (Day 1) in Body Weight at Week 24||Day 1, Week 24|FAS included all randomized participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug. Here 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||kg||95% Confidence Interval|Least Squares Mean
2585254|NCT02347657|Secondary|Absolute Change From Baseline (Day 1) in BMI Z-score at Week 24 in Participants Less Than (<) 20 Years Old at the Time of Screening)|BMI was defined as weight in kg divided by height in m^2. z-score is a statistical measure to describe whether a mean was above or below the standard. BMI, adjusted for age and sex, was analyzed as BMI-for-age z-score (BMI z-score).|Day 1, Week 24|Analysis population included all randomized participants who received at least 1 dose of study drug and were <20 years of age at the time of screening. Here 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||z-score||95% Confidence Interval|Least Squares Mean
2585255|NCT02347657|Secondary|Absolute Change From Baseline (Day 1) in Sweat Chloride Through Week 24|Sweat samples were collected using an approved collection device.|Day 1, Through Week 24|FAS included all randomized participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug. Here 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2585256|NCT02347657|Secondary|Number of Participants With at Least One Pulmonary Exacerbation Pulmonary Exacerbation Through Week 24|Pulmonary exacerbation was defined as a new event or change in antibiotic therapy for greater than or equal to 4 sinopulmonary signs/symptoms. Time to event data was not collected and instead, Number of Subjects with first event were collected and are reported. Time-to-first pulmonary exacerbation was planned to be estimated using Kaplan-Meier (KM) estimates. However, due to less than 50% of events, time-to-first event data was not estimated. Instead, number of participants with at least one pulmonary exacerbation event were collected and are reported.|Day 1 through Week 24|FAS included all randomized participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug.|||Participants|||Count of Participants
2585257|NCT02347657|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or newly developed at or after initial dosing of study drug to Week 28 was considered treatment-emergent.|Day 1 up to Week 28|Safety Set included all participants who received at least 1 dose of the study drug.|||Participants|||Count of Participants
2585258|NCT02347657|Secondary|Absolute Change From Baseline (Day 1) in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 24|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Day 1, Through Week 24|FAS included all randomized participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug. Here 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2585259|NCT02347657|Secondary|Absolute Change From Baseline (Day 1) Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilograms (kg) divided by height in square meter (m^2).|Day 1, Week 24|FAS included all randomized participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug. Here 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||kilogram per square meter (kg/m^2)||95% Confidence Interval|Least Squares Mean
2585260|NCT02347657|Secondary|Number of Pulmonary Exacerbations Per Year|Pulmonary exacerbation was defined as a new event or change in antibiotic therapy for greater than or equal to 4 sinopulmonary signs/symptoms. Pulmonary exacerbation events per year (48 weeks) were reported.|Day 1 through Week 24|FAS included all randomized participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug.|||pulmonary exacerbation events per year|||Number
2585261|NCT02347657|Secondary|Relative Change From Baseline (Day 1) in ppFEV1 Through Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Day 1, Through Week 24|FAS included all randomized participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug. Here 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||percent change||95% Confidence Interval|Least Squares Mean
2585262|NCT02347657|Primary|Absolute Change From Baseline (Day 1) in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Day 1, Through Week 24|FAS included all randomized participants who carry the intended CFTR allele mutation and have received at least 1 dose of study drug. Here 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||Percentage of predicted FEV1||95% Confidence Interval|Least Squares Mean
2585263|NCT02347605|Primary|Withdrawal Symptom Severity Score Assessed Via Questionnaire|Withdrawal as assessed via the Minnesota Nicotine Withdrawal Scale. The score range is from 0 to 28 with higher scores indicating more severe withdrawal symptoms. The outcome measure is the change in withdrawal score from before cue exposure to the withdrawal score after cue exposure.|approximately 15 minutes||||units on a scale||Standard Error|Least Squares Mean
2585264|NCT02347605|Primary|Craving Symptom Severity Score Assessed Via Questionnaire|Craving as assessed via the craving question on the Minnesota Nicotine Withdrawal Scale. The score range is from 0 (no craving) to 4 (severe craving). The outcome measure is the change in craving score from before cue exposure to craving score after cue exposure.|approximately 15 minutes||||units on a scale||Standard Error|Least Squares Mean
2585265|NCT02347488|Secondary|Potentially High Extubation Risk|Number of participants experiencing ETT movement >4cm under each fixation technique|5 minutes after intubation (which occurs at the very beginning of the anesthesia about 2-5 minutes after the patient goes to sleep)||||Participants|||Count of Participants
2585266|NCT02347488|Secondary|Clinically Significant Movement|Number of participants experiencing ETT movement >1cm under each fixation technique|5 minutes after intubation (which occurs at the very beginning of the anesthesia about 2-5 minutes after the patient goes to sleep)||||Participants|||Count of Participants
2585321|NCT02347072|Secondary|Peak Change From Baseline in IC Morning|Peak Change From Baseline in IC Morning|Baseline and Day 29|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements|||Liters||95% Confidence Interval|Least Squares Mean
2585322|NCT02347072|Secondary|Peak Change From Baseline in IC (Inspiratory Capacity) Evening|Peak Change From Baseline in IC Evening|Baseline and Day 29|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements|||Liters||95% Confidence Interval|Least Squares Mean
2585267|NCT02347488|Secondary|Participants With Irritation or Minor Injury to the Face and Oral Structures Likely Attributable to the Study Device|The patients were examined after surgery (both immediately after surgery and at the end of the recovery room period) to determine if the patient suffered any irritation or minor injury to the face and oral structures. The patients were asked to fill out a questionnaire after recovery with questions about their overall experience with specific relation to any irritation and/or minor trauma to their face, oral structures, throat, jaw, and temporomandibular joint.|Immediately after surgery and 1-3 days following surgery, before discharge.|29 patients returned the survey (one patient was aphasic post-op and could not compete the survey)|||Participants|||Count of Participants
2585268|NCT02347488|Primary|Change in ETT Position|The ability of the securing device to resist endotracheal tube dislodgement under axial strain for patients in the supine position was measured. The endotracheal tube, once secured with either tape or the Haider airway device, encountered an axial force to simulate the endotracheal tube being pulled from the mouth. The force increased over approximately 5 seconds until the target of 15 N was reached or until the principal investigator deemed that the force be aborted to prevent possible tracheal extubation. The change in position, measured in cm, was recorded.|5 minutes after intubation (which occurs at the beginning of the anesthesia about 2-5 minutes after the patient goes to sleep).||||centimeters||Standard Deviation|Mean
2585269|NCT02347345|Secondary|Gene Expression Profiles|Gene expression profiles in PBMC will be determined using RNA Seq|24 weeks|9/10 Active injectors, 11/12 former injectors and 12/12 healthy volunteers completed the study. Healthy volunteers were only studied at baseline. No data for weeks 4, 12, 24.|||RNA seq different from active IDU|||Number
2585270|NCT02347345|Secondary|Virologic Response to Therapy as Measured by HCV RNA|HCV RNA levels in plasma (IU/mL)|24 weeks|9/10 Active injectors, 11/12 former injectors and 12/12 healthy volunteers completed the study. Healthy volunteers are HCV uninfected therefore HCV RNA levels are not measured on this group of participants.|||HCV RNA copies/mL plasma||Standard Deviation|Mean
2585271|NCT02347345|Primary|sCD14 (ng/mL)|Marker of immune activation as measured by levels of soluble CD14. Note that the levels of sCD14 were only measured at baseline in the Healthy Volunteers group and therefore there are no data for weeks 4, 12, or 24 entered.|24 weeks|9/10 Active injectors, 11/12 former injectors and 12/12 healthy volunteers completed the study.|||ng/mL||Standard Deviation|Mean
2585272|NCT02347332|Secondary|Duration of Response|Duration of objective response will be measured for responders (CR+PR) from the time for CR or PR until the 1st date of documentation of recurrent or progressive disease or the date of death any cause.|30 months|ITT|||Months||95% Confidence Interval|Median
2585273|NCT02347332|Secondary|Disease Control Rate|Percentage of best overall responses CR, PR and SD in the analysed population|30 months||||% patients||95% Confidence Interval|Median
2585274|NCT02347332|Secondary|Objective Response Rate (ORR)|The objective response is defined as the best response designation recorded across all time points from the date of randomisation until disease progression.|6 weeks||||Percent of participants||95% Confidence Interval|Median
2585275|NCT02347332|Secondary|Progression Free Survival|Time measured from the date of randomisation until date of progression or death from any cause (whichever came first)|an expected average of 4 months|ITT|||Months||95% Confidence Interval|Median
2585276|NCT02347332|Primary|Overall Survival in the ITT Population (Months)|Time from randomization to the date of death or last follow-up. The survival duration of patients still alive, was censored at the date of last contact or last follow-up.|Participants will be followed till death (if they are not lost for follow-up), an expected average of 7.5 months|ITT population|||Months||95% Confidence Interval|Median
2585277|NCT02347189|Secondary|Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016|"Kaplan-Meier: Freedom from Stent Fracture~Kaplan-Meier: Freedom from re-intervention on the Melody TPV PB1016~Kaplan-Meier: Freedom from RVOT Conduit Operation~Kaplan-Meier: Freedom from Death (All-Cause)"|2 years||||percentage of subjects|||Number
2585278|NCT02347189|Secondary|Number of Subjects With Procedural Success|"A successful implant is defined as follows:~Melody TPV PB1016 is fixated within the desired location~RV-PA peak-to-peak gradient measured in the catheterization lab after Melody TPV PB1016 implantation is < 35 mmHg~No more than trace/trivial pulmonary regurgitation by angiography~Subject is free from explantation of the Melody TPV PB1016 at 24 hours post-implant."|At Time Of Procedure|In one subject, the right ventricle to pulmonary artery (RV-PA) peak-to-peak gradient was not collected, leaving the overall number of evaluable subjects analyzed at 29 versus 30.|||Participants|||Count of Participants
2585279|NCT02347189|Secondary|Number of Subjects With Serious Procedure-related and Device-related Adverse Events|"Serious procedure-related adverse events at 1year and 2 years post-implant~Serious device-related adverse events at 1 year and 2 years post-implant"|1 Year, 2 Years||||Participants|||Count of Participants
2585280|NCT02347189|Secondary|Number of Subjects With Acceptable TPV Hemodynamic Function at 2 Years|"Acceptable TPV hemodynamic function at 2 years after successful TPV implantation which is determined as a composite of the following:~Mean RVOT gradient is ≤ 30 mmHg as measured by CW Doppler~Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography~Free from RVOT conduit reoperation or catheter re-intervention on the TPV at 2 years post-TPV implantation."|2 Years|27 subjects successfully implanted for greater than 24 hours (out of 30 total) had evaluable data at 2 years.|||Participants|||Count of Participants
2585281|NCT02347189|Secondary|Number of Subjects With Acceptable TPV Hemodynamic Function At 1 Year|"Acceptable TPV hemodynamic function at 1 year after successful TPV implantation which is determined as a composite of the following:~Mean RVOT gradient is ≤ 30 mmHg as measured by CW Doppler~Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography~Free from RVOT conduit reoperation or catheter re-intervention on the TPV at 1 year post-TPV implantation."|1 Year|25 subjects successfully implanted for greater than 24 hours (out of 30 total) had evaluable data at 1 year.|||Participants|||Count of Participants
2585323|NCT02347072|Secondary|Morning Pre-Dose Trough FEV1 on Day 30|Morning Pre-Dose Trough FEV1 on Day 30|Day 30|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements|||Liters||95% Confidence Interval|Least Squares Mean
2585324|NCT02347072|Secondary|Morning Pre-Dose Trough FEV1 on Day 29|Morning Pre-Dose Trough FEV1 on Day 29|Day 29|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements|||Liters||95% Confidence Interval|Least Squares Mean
2585282|NCT02347189|Primary|Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months|"Acceptable TPV hemodynamic function at six months after successful TPV implantation which is determined as a composite of the following:~Mean Right Ventricular Outflow Tract (RVOT) gradient is less than or equal to 30 mmHg as measured by Continuous-wave Doppler (CW Doppler) echocardiography, and~Severity of pulmonary regurgitation less than moderate by CW Doppler echocardiography, and~Free from RVOT conduit reoperation or catheter re-intervention on the TPV at six months post-TPV implantation"|6 Months|28 subjects successfully implanted for greater than 24 hours (out of 30 total) had evaluable data at 6 months.|||Participants|||Count of Participants
2585283|NCT02347176|Secondary|Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12|Pruritus assessed using an NRS (0 - 10) with 0= no itch and 10= worst imaginable itch. Daily pruritus assessments were summarized as weekly peak score and a change from baseline in weekly peak score was calculated. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.|Baseline (Day 1) and Week 12|"The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category Number Analyzed is number of participants analyzed for this outcome measure."|||units on a scale||Standard Error|Mean
2585284|NCT02347176|Secondary|Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12|SCORAD 50 responder is defined as a participant who achieves at least a 50% reduction in SCORAD score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a LOCF analysis was used.|Week 12|"The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category Number Analyzed is number of participants analyzed for this outcome measure."|||Percentage of participants|||Number
2585285|NCT02347176|Secondary|Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12|The SCORAD is a clinical tool for assessing the severity (that is, extent, intensity) of atopic dermatitis (AD). The tool evaluates the extent and intensity of the AD lesions, along with participant symptoms. The maximum total score is 103, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.|Baseline (Day 1) and Week 12|"The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category Number Analyzed is number of participants analyzed for this outcome measure."|||units on a scale||Standard Error|Mean
2585286|NCT02347176|Secondary|Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12|EASI50 responder is defined as a participant who achieves at least a 50% reduction in EASI score from baseline. Data from participants who took prohibited medications were excluded from this analysis and a last observation carried forward (LOCF) analysis was used.|Week 12|"The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category Number Analyzed is number of participants analyzed for this outcome measure."|||Percentage of participants|||Number
2585287|NCT02347176|Secondary|Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events|AEs observed in participants with clinically significant ECG abnormalities were assessed. ECG parameters included heart rate, RR, PR, QRS and QT intervals. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.|From Study Drug Administration (Day 1) to Week 22|As-treated population included all treated participants, grouped according to actual treatment received.|||Participants|||Count of Participants
2585288|NCT02347176|Secondary|Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.|From Study Drug Administration (Day 1) to Week 22|As-treated population included all treated participants, grouped according to actual treatment received.|||Participants|||Count of Participants
2585289|NCT02347176|Secondary|Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events|Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. TEAEs were present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug until Week 22.|From Study Drug Administration (Day 1) to Week 22|As-treated population included all treated participants, grouped according to actual treatment received.|||Participants|||Count of Participants
2585290|NCT02347176|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug until Week 22. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received Tralokinumab. Treatment-emergent adverse events between administration of investigational product and Week 22 that were absent before treatment or that worsened relative to pre-treatment state.|From Study Drug Administration (Day 1) to Week 22|As-treated population included all treated participants, grouped according to actual treatment received.|||Participants|||Count of Participants
2585325|NCT02347072|Secondary|Peak Change From Baseline in FEV1 Morning|Peak Change From Baseline in FEV1 Morning|Baseline and Day 29|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements|||Liters||95% Confidence Interval|Least Squares Mean
2585326|NCT02347072|Secondary|Peak Change From Baseline in FEV1 Evening|Peak Change From Baseline in FEV1 Evening|Baseline and Day 29|MITT Population|||Liters||95% Confidence Interval|Least Squares Mean
2585327|NCT02347072|Secondary|FEV1 AUC0-12|Normalized FEV1 AUC0-12|Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the morning dose on Day 29|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements|||Liters||95% Confidence Interval|Least Squares Mean
2585291|NCT02347176|Primary|Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12|The IGA allows investigators to assess overall disease severity at one given time point and consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline.|Week 12|"The ITT population included all randomized and treated participants, grouped according to assigned treatment. Here, the category Number Analyzed is number of participants analyzed for this outcome measure."|||Percentage of participants|||Number
2585292|NCT02347176|Primary|Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12|EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.|Baseline (Day 1) and Week 12|"The intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. Here, the category Number Analyzed is number of participants analyzed for this outcome measure."|||units on a scale||Standard Error|Mean
2585293|NCT02347124|Other Pre-specified|Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 6-month Follow-up|"SE to quit smoking was assessed using the following question:~As of today, how confident are you that you can…stop smoking for good or remain quit?~Responses were measured on a 5-point Likert scale ranging from 1=Not at all confident, to 5=Very confident. Higher scores represented higher SE.~The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score.~The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy."|Baseline to 6 months|Participants who provided responses to this item at baseline and 6 month follow-up.|||scores on a scale||Standard Deviation|Mean
2585294|NCT02347124|Other Pre-specified|Change in Self-efficacy (SE) for Quitting Smoking, From Baseline to 2-month Follow-up|"SE to quit smoking was assessed using the following question:~As of today, how confident are you that you can…stop smoking for good or remain quit?~Responses were measured on a 5-point Likert scale ranging from 1=Not at all confident, to 5=Very confident. Higher scores represented higher SE.~The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score.~The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy."|Baseline to 2 months|Participants who provided responses to this item at baseline and 2 month follow-up.|||scores on a scale||Standard Deviation|Mean
2585295|NCT02347124|Other Pre-specified|Change in Motivation for Seeing a Dentist, From Baseline to 6-month Follow-up|"Motivation to see a dentist was assessed using the following question:~As of today, how motivated are you to…see a dentist in the next 6 months?~Responses were measured on a 5-point Likert scale ranging from 1=Not at all motivated, to 5=Very motivated. Higher scores represented higher motivation.~The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score.~The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation."|Baseline to 6 months|Participants who provided responses to this item at baseline and 6 month follow-up.|||scores on a scale||Standard Deviation|Mean
2585296|NCT02347124|Other Pre-specified|Change in Motivation for Seeing a Dentist, From Baseline to 2-month Follow-up|"Motivation to see a dentist was assessed using the following question:~As of today, how motivated are you to…see a dentist in the next 6 months?~Responses were measured on a 5-point Likert scale ranging from 1=Not at all motivated, to 5=Very motivated. Higher scores represented higher motivation.~The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score.~The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation."|Baseline to 2 months|Participants who provided responses to this item at baseline and 2 month follow-up.|||scores on a scale||Standard Deviation|Mean
2585297|NCT02347124|Other Pre-specified|Change in Motivation to Stop Smoking, From Baseline to 6 Month Follow-up|"Motivation to stop smoking was assessed using the following question:~As of today, how motivated are you to…Stop smoking for good or remain quit?~Responses were measured on a 5-point Likert scale ranging from 1=Not at all motivated, to 5=Very motivated. Higher scores represented higher motivation.~The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score.~The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation."|Baseline to 6 months|Participants providing responses to this item at baseline and 6-month follow-up|||scores on a scale||Standard Deviation|Mean
2585298|NCT02347124|Other Pre-specified|Change in Motivation to Stop Smoking, From Baseline to 2 Month Follow-up|"Motivation to stop smoking was assessed using the following question:~As of today, how motivated are you to…Stop smoking for good or remain quit?~Responses were measured on a 5-point Likert scale ranging from 1=Not at all motivated, to 5=Very motivated. Higher scores represented higher motivation.~The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score.~The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in motivation, and negative scores indicating a decrease in motivation."|Baseline to 2 months|Participants providing responses to this item at baseline and 2 month follow-up|||scores on a scale||Standard Deviation|Mean
2585328|NCT02347072|Secondary|FEV1 AUC12-24|Normalized FEV1 AUC12-24|Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the evening dose on Day 29|Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements|||Liters||95% Confidence Interval|Least Squares Mean
2587262|NCT02320838|Secondary|Thermal Pain Threshold Post-treatment 40 Min.|The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC|at 40 min. post-treatment||||ºC||Standard Deviation|Mean
2585299|NCT02347124|Other Pre-specified|Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 6 Month Follow-up|"SE to see a dentist was assessed using the following question:~As of today, how confident are you that you can…See a dentist in the next 6 months?~Responses were measured on a 5-point Likert scale ranging from 1=Not at all confident, to 5=Very confident. Higher scores represented higher SE.~The study outcome is the change in this score, between baseline and the 6-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy."|Baseline to 6 months|Participants who provided responses to this item at baseline and 6 month follow-up.|||scores on a scale||Standard Deviation|Mean
2585300|NCT02347124|Other Pre-specified|Change in Self-efficacy (SE) for Seeing a Dentist, From Baseline to 2 Month Follow up|"SE to see a dentist was assessed using the following question:~As of today, how confident are you that you can…See a dentist in the next 6 months?~Responses were measured on a 5-point Likert scale ranging from 1=Not at all confident, to 5=Very confident. Higher scores represented higher SE.~The study outcome is the change in this score, between baseline and the 2-month follow-up. Therefore, the outcome is defined as the difference in score. The theoretical range for the change score is -4 (minimum) to 4 (maximum), with positive scores indicating an increase in self-efficacy, and negative scores indicating a decrease in self-efficacy."|Baseline to 2 months|Participants who provided responses to this item at baseline and 2 follow-up.|||scores on a scale||Standard Deviation|Mean
2585301|NCT02347124|Other Pre-specified|Change in Oral Health Knowledge Scale Score From Baseline to 6 Month Follow-up|"Oral health knowledge was assessed via the Brennan et al. 2010 scale, adapted from the Health Promotion and Disease Prevention Questionnaire (1985 NHIS; Corbin et al). Seven questions make up the scale:~Seeing a dentist regularly Drinking water with fluoride Regular brushing of teeth Regular flossing of teeth Using fluoride toothpaste Avoiding sweets between meals.~Responses and scoring to the adapted NHIS scale:~Definitely not important = 1 Probably not important = 2 Neutral = 3 Probably important = 4 Definitely important = 5~Scale scores are calculated by summing the responses to the 7 items, with higher scores indicating higher oral health knowledge.~The scores have a range of 7 (minimum) to 35 (maximum).~The study outcome is the change in this score between BL and 6 mos. The outcome is the difference in scores. A positive score indicates an increase in oral health knowledge (larger=better). A negative score indicates a decrease in knowledge."|Baseline to 6 months|Participants providing data for this measure at baseline and 6 month follow-up.|||scores on a scale||Standard Deviation|Mean
2585302|NCT02347124|Other Pre-specified|Change in Oral Health Knowledge Scale Score From Baseline to 2 Month Follow up|"Oral health knowledge was assessed via the Brennan et al. 2010 scale, adapted from the Health Promotion and Disease Prevention Questionnaire (1985 NHIS; Corbin et al). Seven questions make up the scale:~Seeing a dentist regularly Drinking water with fluoride Regular brushing of teeth Regular flossing of teeth Using fluoride toothpaste Avoiding sweets between meals.~Responses and scoring to the adapted NHIS scale:~Definitely not important = 1 Probably not important = 2 Neutral = 3 Probably important = 4 Definitely important = 5~Scale scores are calculated by summing the responses to the 7 items, with higher scores indicating higher oral health knowledge.~The scores have a range of 7 (minimum) to 35 (maximum).~The study outcome is the change in this score between BL and 2 mos. The outcome is the difference in scores. A positive score indicates an increase in oral health knowledge (larger=better). A negative score indicates a decrease in knowledge."|Baseline to 2 months|Participants providing data for this measure at the baseline and 2 month follow-up.|||scores on a scale||Standard Deviation|Mean
2585303|NCT02347124|Secondary|7 Day Point Prevalent Smoking Abstinence (PPA)|Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis. No outcomes imputed.|6 months post-enrollment|Complete case analysis limited to survey respondents.|||Participants|||Count of Participants
2585304|NCT02347124|Secondary|7 Day Point Prevalent Smoking Abstinence (PPA)|Self-reported 7 day point prevalence abstinence (PPA) in complete case analysis, using respondent data only. No outcomes imputed.|2 months post-enrollment|Analysis limited to survey respondents (i.e., complete cases only).|||Participants|||Count of Participants
2585305|NCT02347124|Secondary|7 Day Point Prevalent Abstinence (PPA)|7 day point prevalence abstinence (PPA): self-report of no smoking in the past 7 days with missing outcomes imputed as smokers|2 months post-enrollment|All participants with missing data imputed as smokers.|||Participants|||Count of Participants
2585306|NCT02347124|Primary|Professional Dental Care Utilization in Past 6 Months|self-reported utilization of professional dental care during study observation period|6 months post-enrollment|All participants with missing data imputed as not having seen a dentist.|||Participants|||Count of Participants
2585307|NCT02347124|Primary|7 Day Point Prevalent Abstinence (PPA)|7 day point prevalent abstinence (PPA): self- report of no smoking in the past 7 days. Missing values imputed as smokers.|6 month post-enrollment|All participants with missing data imputed as smokers.|||Participants|||Count of Participants
2585308|NCT02347098|Secondary|Major Adverse CV Events|The number of patients who experienced major adverse cardiovascular endpoints (MACE) including death, myocardial infarction, coronary revascularization, and stroke during the follow-up periods.|6 months||||Participants|||Count of Participants
2585309|NCT02347098|Secondary|Endothelial Progenitor Cell Colony Forming Units/ml of Peripheral Blood Across Time|The cell culture assay and quantification of circulating EPC-CFU were performed for patients recruited at the Dallas VA center only. The assay were done at 4 time points (pre-PCI, post-PCI, 30-day follow-up, and 90-day follow-up).|12 weeks|Reported results are based on observed data from participants who had secondary outcome measured. This outcome was captured for Dallas site only.|||colonies/ml||Standard Deviation|Mean
2585310|NCT02347098|Secondary|Change in % Necrotic Core Component of Atheroma|The %NC component of atheroma were obtained via IVUS-VH at 2 time points (baseline during index PCI and 90-day follow-up).|12 weeks|Reported results are based on observed data from participants who had secondary outcome measured.|||percentage of atheroma component||Standard Deviation|Mean
2585311|NCT02347098|Primary|Change in the Total Atheroma Volume From Baseline to 12 Weeks|The primary effectiveness outcome measure was the change in the total atheroma volume within a ≥ 20 mm long segment of the target coronary artery from baseline to 12 weeks post-PCI. The measurement was done via IVUS-VH at 2 time points (baseline during index PCI and 90-day follow-up).|12 weeks|Reported results are based on observed data from participants who had primary outcome measured.|||mm^3||Standard Deviation|Mean
2585329|NCT02347072|Primary|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-24|Normalized Forced Expiratory Volume in 1 second (FEV1) Area Under the Curve (AUC) 0-24|Pre dose, 15 and 30 minutes, 1, 2, 4, 8, 12, 12.25, 12.5, 13, 14, 16, 22, and 24 hours post the morning dose on Day 29|Subjects in the Modified Intent to Treat (MITT) Population who had a sufficient number of post dose FEV1 measurements|||Liters||95% Confidence Interval|Least Squares Mean
2585330|NCT02346877|Secondary|Beliefs About Medicines Questionnaire (BMQ)|BMQ consists of two five-item scales assessing patients' beliefs about the necessity of Enbrel® for controlling their rheumatoid arthritis and their concerns about potential adverse consequences of taking Enbrel®. Using a five-point Likert scale, on each of necessity and concerns, the individual items within both scales are summed. The total scores for the Necessity and Concerns Scales range from 5 to 25. Higher scores indicate stronger beliefs.|52 weeks|Efficacy endpoints were not evaluated because the study was prematurely closed and no participants completed the study.||||||
2585331|NCT02346877|Secondary|Adherence to Study Drug up to 52 Weeks|A participant's adherence is determined as a medication possession ratio (MPR) of at least 80%. The MPR is the ratio of the total number of weeks' supply, based on pharmacy data, of Enbrel® divided by either 52 weeks or duration on study if a physician stops prescribing Enbrel® due to an adverse drug reaction or lack of efficacy.|52 weeks|Efficacy endpoints were not evaluated because the study was prematurely closed and no participants completed the study.||||||
2585332|NCT02346877|Primary|Persistence of Study Drug Measured at 52 Weeks|A participant is persistent if the date of the last prescription filled plus the number of weeks supply of the prescription is greater than or equal to 52 weeks from enrolment and the eDiary confirms Enbrel® from the prescription was injected. A participant is not persistent if the last prescription filled plus the number of weeks supply of the prescription is less than 52 weeks from enrolment and the eDiary confirms there was no injection of Enbrel®, or, a participant is not persistent if the participant has a gap in treatment of more than 4 consecutive weeks for no medical reason at any time in the 52 week study period.|52 weeks|Efficacy endpoints were not evaluated because the study was prematurely closed and no participants completed the study.||||||
2585333|NCT02346721|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2585334|NCT02346721|Secondary|HCV RNA Change From Baseline||Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2585335|NCT02346721|Secondary|Percentage of Participants With HCV RNA < LLOQ While on Treatment||Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2585336|NCT02346721|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2585337|NCT02346721|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
2585338|NCT02346721|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set (FAS) included all enrolled participants who took at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2585339|NCT02346643|Primary|Pain Intensity in Overall Pain|"Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) from Pre-Treatment Baseline~The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain)."|Post treatment at 3, 6 and 12 months|Differences in participants over time is due to early withdrawals and missing data|||units on a scale||Standard Deviation|Mean
2585340|NCT02346643|Primary|Pain Intensity in Primary Region of Pain|"Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) from Pre-Treatment Baseline.~The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain)."|Post treatment at 3, 6 and 12 months|Differences in participants over time is due to early withdrawals and missing data|||units on a scale||Standard Deviation|Mean
2585341|NCT02346461|Primary|The Time to Cmax (Tmax) for Neu5Ac|The time taken to achieve the maximum observed plasma concentration for Neu5Ac.|Day 7|All subjects received ManNAc|||hours||Standard Deviation|Median
2585342|NCT02346461|Primary|Maximum Observed Plasma Concentration (Cmax) of Neu5Ac (Baseline-adjusted)|The maximum (or peak) plasma Neu5Ac concentration that the drug achieves in the body after the drug has been administrated.|Day 7|All subjects received ManNAc|||ng/mL||Standard Deviation|Geometric Mean
2585343|NCT02346461|Primary|Mean Area Under the Curve (AUClast) of Plasma Neu5Ac (Baseline-adjusted)|The mean area under the plasma Neu5Ac concentration-versus time curve from time 0 (dosing) to the time of last quantifiable concentration.|Day 7|All subjects received ManNAc|||hr*ng/mL||Standard Deviation|Mean
2585344|NCT02346461|Primary|Half-life (t ½) for ManNAc|The amount of time it takes for plasma ManNAc concentration to decline by half.|Day 7|All subjects received ManNAc|||hours||Standard Deviation|Median
2585345|NCT02346461|Primary|The Time to Cmax (Tmax) for ManNAc|The time taken to achieve the maximum observed plasma concentration for ManNAc .|Day 7|All subjects received ManNAc|||hours||Standard Deviation|Median
2585380|NCT02346136|Secondary|Mobility|Mobility will be assessed by the Timed Up-and-Go, which records the time needed to stand from a chair, walk three meters, turn, walk back to the chair and sit down.|Change from baseline to 6 months||||seconds||Standard Error|Least Squares Mean
2585346|NCT02346461|Primary|Maximum Observed Plasma Concentration (Cmax) of ManNAc (Baseline-adjusted)|The maximum (or peak) plasma ManNAc concentration that the drug achieves in the body after the drug has been administrated.|Day 7|All subjects received ManNAc|||ng/mL||Standard Deviation|Geometric Mean
2585347|NCT02346461|Primary|Mean Area Under the Curve (AUClast) of Plasma ManNAc (Baseline-adjusted)|The mean area under the plasma ManNAc concentration-versus time curve from time 0 (dosing) to the time of last quantifiable concentration.|Day 7|All subjects received ManNAc|||hr*ng/mL||Standard Deviation|Mean
2585348|NCT02346370|Secondary|Progression-free Survival (PFS)||From date of treatment start until date of first documentation of progressive disease or death from any cause, assessed up to 1 year 9 months|Due to early discontinuation of the study, PFS was not assessed.||||||
2585349|NCT02346370|Secondary|Duration of Response (DoR)||From date of first CR or PR until the date of first documentation of disease progression or date of death, assessed up to data cutoff date (30 Nov 2016)|Due to early discontinuation of the study, DoR was not assessed.||||||
2585350|NCT02346370|Secondary|Disease Control Rate (DCR)||From date of treatment start until disease progression or up to data cutoff date (30 Nov 2016), for up to approximately 1 year 9 months|Due to early discontinuation of the study, DCR was not assessed.||||||
2585351|NCT02346370|Secondary|Objective Response Rate (ORR)|ORR = complete response + partial response (CR + PR)|From date of treatment start until disease progression or up to data cutoff date (30 Nov 2016), for up to approximately 1 year 9 months|Due to early discontinuation of the study, ORR was not assessed.||||||
2585352|NCT02346370|Secondary|Phase 1b: Clearance (CL) of PEGPH20 and Docetaxel|Blood samples were collected from all participants per protocol and analyzed for plasma PEGPH20 concentration using a validated ECL immunoassay. Plasma docetaxel concentrations were analyzed using a validated liquid chromatography with LS-MS/MS. The following blood draw schedule was used, PEGPH20: C1D1 (predose, 15 min, 1, 2 to 4, and 24 hr postdose), C2 and all subsequent Cycles (predose, 1 hr postdose). Docetaxel: C1D2 (30 min after the start of the 1-hr infusion, 30 min post completion of the infusion, 4 to 6 and 24 hr post infusion), C1D3 (24 hr post infusion), C2D2 and C3D2 (30 min after the start of the 1-hour infusion, 30 min post completion of the infusion).|PEGPH20: multiple time points C1D1 and all subsequent Cycles; Docetaxel: multiple time points C1D2, C2D2 and C3D2|Due to early discontinuation of the study, CL was not assessed.||||||
2585353|NCT02346370|Secondary|Phase 1b: Volume of Distribution (Vd) of PEGPH20 and Docetaxel|Blood samples were collected from all participants per protocol and analyzed for plasma PEGPH20 concentration using a validated ECL immunoassay. Plasma docetaxel concentrations were analyzed using a validated liquid chromatography with LS-MS/MS. The following blood draw schedule was used, PEGPH20: C1D1 (predose, 15 min, 1, 2 to 4, and 24 hr postdose), C2 and all subsequent Cycles (predose, 1 hr postdose). Docetaxel: C1D2 (30 min after the start of the 1-hr infusion, 30 min post completion of the infusion, 4 to 6 and 24 hr post infusion), C1D3 (24 hr post infusion), C2D2 and C3D2 (30 min after the start of the 1-hour infusion, 30 min post completion of the infusion).|PEGPH20: multiple time points C1D1 and all subsequent Cycles; Docetaxel: multiple time points C1D2, C2D2 and C3D2|Due to early discontinuation of the study, Vd was not assessed.||||||
2585354|NCT02346370|Secondary|Phase 1b: Area Under the Plasma Concentration-Time Curve for PEGPH20 and Docetaxel|Blood samples were collected from all participants per protocol and analyzed for plasma PEGPH20 concentration using a validated ECL immunoassay. Plasma docetaxel concentrations were analyzed using a validated liquid chromatography with LS-MS/MS. The following blood draw schedule was used, PEGPH20: C1D1 (predose, 15 min, 1, 2 to 4, and 24 hr postdose), C2 and all subsequent Cycles (predose, 1 hr postdose). Docetaxel: C1D2 (30 min after the start of the 1-hr infusion, 30 min post completion of the infusion, 4 to 6 and 24 hr post infusion), C1D3 (24 hr post infusion), C2D2 and C3D2 (30 min after the start of the 1-hour infusion, 30 min post completion of the infusion).|PEGPH20: multiple time points C1D1 and all subsequent Cycles; Docetaxel: multiple time points C1D2, C2D2 and C3D2|Due to early discontinuation of the study, the AUC was not assessed.||||||
2585355|NCT02346370|Secondary|Phase 1b: Terminal Half-life (t1/2) of PEGPH20 and Docetaxel|Blood samples were collected from all participants per protocol and analyzed for plasma PEGPH20 concentration using a validated ECL immunoassay. Plasma docetaxel concentrations were analyzed using a validated liquid chromatography with LS-MS/MS. The following blood draw schedule was used, PEGPH20: C1D1 (predose, 15 min, 1, 2 to 4, and 24 hr postdose), C2 and all subsequent Cycles (predose, 1 hr postdose). Docetaxel: C1D2 (30 min after the start of the 1-hr infusion, 30 min post completion of the infusion, 4 to 6 and 24 hr post infusion), C1D3 (24 hr post infusion), C2D2 and C3D2 (30 min after the start of the 1-hour infusion, 30 min post completion of the infusion).|PEGPH20: multiple time points C1D1 and all subsequent Cycles; Docetaxel: multiple time points C1D2, C2D2 and C3D2|Due to early discontinuation of the study, t1/2 was not assessed.||||||
2585356|NCT02346370|Secondary|Phase 1b: Time to Maximum Plasma Concentration (Tmax) of PEGPH20 and Docetaxel|Blood samples were collected from all participants per protocol and analyzed for plasma PEGPH20 concentration using a validated ECL immunoassay. Plasma docetaxel concentrations were analyzed using a validated liquid chromatography with LS-MS/MS. The following blood draw schedule was used, PEGPH20: C1D1 (predose, 15 min, 1, 2 to 4, and 24 hr postdose), C2 and all subsequent Cycles (predose, 1 hr postdose). Docetaxel: C1D2 (30 min after the start of the 1-hr infusion, 30 min post completion of the infusion, 4 to 6 and 24 hr post infusion), C1D3 (24 hr post infusion), C2D2 and C3D2 (30 min after the start of the 1-hour infusion, 30 min post completion of the infusion).|PEGPH20: multiple time points C1D1 and all subsequent Cycles; Docetaxel: multiple time points C1D2, C2D2 and C3D2|Due to early discontinuation of the study, Tmax was not assessed.||||||
2585357|NCT02346370|Secondary|Phase 1b: Minimum Plasma Concentration (Cmin) of PEGPH20 and Docetaxel|Blood samples were collected from all participants per protocol and analyzed for plasma PEGPH20 concentration using a validated ECL immunoassay. Plasma docetaxel concentrations were analyzed using a validated liquid chromatography with LS-MS/MS. The following blood draw schedule was used, PEGPH20: C1D1 (predose, 15 min, 1, 2 to 4, and 24 hr postdose), C2 and all subsequent Cycles (predose, 1 hr postdose). Docetaxel: C1D2 (30 min after the start of the 1-hr infusion, 30 min post completion of the infusion, 4 to 6 and 24 hr post infusion), C1D3 (24 hr post infusion), C2D2 and C3D2 (30 min after the start of the 1-hour infusion, 30 min post completion of the infusion).|PEGPH20: multiple time points C1D1 and all subsequent Cycles; Docetaxel: multiple time points C1D2, C2D2 and C3D2|Due to early discontinuation of the study, Cmin was not assessed.||||||
2585358|NCT02346370|Secondary|Phase 1b: Maximum Plasma Concentration (Cmax) of PEGPH20 and Docetaxel|Blood samples were collected from all participants per protocol and analyzed for plasma PEGPH20 concentration using a validated electrochemiluminescence (ECL) immunoassay. Plasma docetaxel concentrations were analyzed using a validated liquid chromatography with tandem mass spectrometry assay (LS-MS/MS). The following blood draw schedule was used, PEGPH20: Cycle 1 Day 1 (C1D1) (predose, 15 minutes (min), 1, 2 to 4, and 24 hours (hr) postdose), C2 and all subsequent Cycles (predose, 1 hr postdose). Docetaxel: C1D2 (30 min after the start of the 1-hr infusion, 30 min post completion of the infusion, 4 to 6 and 24 hr post infusion), C1D3 (24 hr post infusion), C2D2 and C3D2 (30 min after the start of the 1-hour infusion, 30 min post completion of the infusion).|PEGPH20: multiple time points C1D1 and all subsequent Cycles; Docetaxel: multiple time points C1D2, C2D2 and C3D2|Due to early discontinuation of the study, Cmax was not assessed.||||||
2585359|NCT02346370|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of PEGPH20||Cycle 1 of Dose Escalation portion (Cycle 1 = 21 days)|The MTD and RP2D were not established due to early study discontinuation.||||||
2585360|NCT02346370|Primary|Number of Participants With the Indicated Type of Adverse Events for PEGPH20 and Docetaxel|Throughout the Treatment Period, the assessment of safety was based on AEs, including deaths, non-serious AEs, and serious adverse events, AEs leading to discontinuation of study treatment, and results of vital sign measurements and clinical laboratory assessments (including hematology, clinical chemistry, coagulation parameters, and urinalysis). Additionally, thromboembolic (TE) events were deemed by the Sponsor as AEs of special interest. AEs and laboratory values were graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.|From date of first dose until 30 days after the last dose of study treatment, up to approximately 1 year 10 months|Safety population|||Participants|||Count of Participants
2585361|NCT02346370|Primary|Number of Dose Limiting Toxicities (DLTs)|DLTs were defined as adverse events (AEs) that occurred during Cycle 1 in the Dose Escalation portion of the study, and deemed by the Investigator as related to study treatment.|Cycle 1 (Day 1 through Day 21) (1 Cycle = 21 days)|The DLT-Evaluable population included all participants who received a full dose of study treatment and completed the initial 21 days of the study after the first dose or who experienced a DLT within the initial 21 days after the first dose and discontinued from the study (if they received a full dose of study drug).|||DLTs|||Number
2585362|NCT02346240|Secondary|Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48 for Those Achieving PASI75 at Week 16|The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.|Week 48|"The Week 16 Randomized Set (WK16RS) consisted of all participants who achieved a PASI75 response at Week 16 and were re-randomized into the double-blind, placebo-controlled Maintenance Treatment Period.~Missing data were handled using non-response imputation (NRI) methods."|||percentage of participants|||Number
2585363|NCT02346240|Secondary|Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16|The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.|Week 16|"The Randomized Set (RS) consisted of all participants randomized into the study.~Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation."|||percentage of participants|||Number
2585364|NCT02346240|Secondary|Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 16|The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.|Week 16|"The Randomized Set (RS) consisted of all participants randomized into the study.~Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation."|||percentage of participants|||Number
2585365|NCT02346240|Secondary|Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16|The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.|Week 16|"The Randomized Set (RS) consisted of all participants randomized into the study.~Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation."|||percentage of participants|||Number
2585456|NCT02345252|Secondary|Percent Change From Baseline in Hip BMD at Week 96|Hip BMD was assessed by DXA scan.|Baseline; Week 96|Participants in the Hip DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2585366|NCT02346240|Secondary|Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 12|The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.|Week 12|"The Randomized Set (RS) consisted of all participants randomized into the study.~Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation."|||percentage of participants|||Number
2585367|NCT02346240|Secondary|Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 12|The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.|Week 12|"The Randomized Set (RS) consisted of all participants randomized into the study.~Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation."|||percentage of participants|||Number
2585368|NCT02346240|Primary|Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 12|The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.|Week 12|"The Randomized Set (RS) consisted of all participants randomized into the study.~Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation."|||percentage of participants|||Number
2585369|NCT02346136|Secondary|Mini-Mental State Examination|The Mini-Mental State Questionnaire is a 30 point questionnaire that is used extensively to measure cognitive impairment. Total score = 30, score ranges are from 0 to 30. A higher score indicates better performance.|Change from baseline to 12 months||||score on a scale||95% Confidence Interval|Least Squares Mean
2585370|NCT02346136|Secondary|Health Care Utilization|Secondary health care utilization outcomes include counts of emergency room visits.|Baseline, 6 months and 12 months|The 142 participants analyzed for health care utilization measures were those enrolled at sites that initiated assigned treatment (excluding 32 participants), had not withdrawn prior to treatment initiation (excludes 4 participants), and for whom at least one assessment of health care utilization was completed (excludes 2 participants).|||Participants|||Count of Participants
2585371|NCT02346136|Secondary|Falls|Falls will be defined as any event in which the participant unintentionally comes to rest on the ground or other lower level, not as a result of a major intrinsic event or an overwhelmingly external hazard. This outcome measure is reporting the sum total number of falls for each intervention.|12 months||||falls|||Number
2585372|NCT02346136|Secondary|Exercise Self-efficacy|Exercise self-efficacy will be assessed with a valid and reliable exercise self-efficacy questionnaire (Activities-specific Balance Confidence (ABC) score). The ABC score ranges from 0-100, with a higher score indicating a better outcome.|Change from baseline to 6 months||||score on a scale||Standard Error|Least Squares Mean
2585373|NCT02346136|Secondary|Depression|Depressive symptoms will be assessed with the Center of Epidemiology Studies-Depression Scale Revised (CESD-R). The 20 item CESD-R test score range is between 0-60, with a lower score representing a better outcome.|Change from baseline to 6 months||||score on a scale||Standard Error|Least Squares Mean
2585374|NCT02346136|Secondary|Health-related Quality-of-life|"Health-related quality-of-life will be assessed with the Short Form-12 (SF-12), which is a 12 item short form survey, a shortened version of the Short Form-36 (SF-36) health survey that is widely-utilized to assess physical and mental health, as well as the outcomes of healthcare services. The total score ranges from 0-100, with a lower score representing a better outcome for *both* the Physical component and Mental Component"|Change from baseline to 6 months||||scores on a scale||Standard Error|Least Squares Mean
2585375|NCT02346136|Secondary|Executive Function|"Executive function will be assessed with the Trail Making Test (TMT). Participants are timed while sequentially connecting a series of numbered circles (TMT part A), as well as connecting an alternating series of numbers and letters (e.g., A-1-B-2-C-3…) (TMT part B).~The outcome measure is the time difference in seconds between Part B and Part A."|Change from baseline to 6 months||||seconds||Standard Error|Least Squares Mean
2585376|NCT02346136|Secondary|Self-reported Physical Activity|Self-reported physical activity will be assessed with the Physical Activity Scale for the Elderly (PASE). The range for this scale is 0-400, with higher score representing higher activity score (better outcome).|Change from baseline to 6 months||||scores on a scale||Standard Deviation|Mean
2585377|NCT02346136|Secondary|Grip Strength|Grip strength of the dominant hand will be assessed with a hand-grip dynamometer in kilograms (kg).|Change from baseline to 6 months||||kg||Standard Deviation|Mean
2585378|NCT02346136|Secondary|Standing Balance|Standing balance will be assessed by recording 95% ellipse sway area with eyes open in meters squared (m2)|Change from baseline to 6 months||||m^2||Standard Error|Least Squares Mean
2585379|NCT02346136|Secondary|Gait Velocity|Gait velocity will be measured in meters/second (m/s) during two conditions: Normal walking (NW) and Dual task(DT) condition (counting backwards by 3's or 1's while walking)|Change from baseline to 6 months||||m/s||Standard Error|Least Squares Mean
2585381|NCT02346136|Primary|Health Care Utilization|Health care utilization will be defined by counts of hospitalizations during the study period.|up to 12 months|The 142 participants analyzed for health care utilization measures were those enrolled at sites that initiated assigned treatment (excluding 32 participants), had not withdrawn prior to treatment initiation (excludes 4 participants), and for whom at least one assessment of health care utilization was completed (excludes 2 participants).|||Participants|||Count of Participants
2585382|NCT02346136|Primary|Change in Short Physical Performance Battery (SPPB) Total Score|The Short Physical Performance Battery includes measures of standing balance (timing of tandem, semi-tandem, and side-by-side stands), 4-meter walking speed and the ability and time to rise from a chair 5 times. The minimum score = 0, the maximum score=12. A higher score means a better outcome.|Change from baseline to 6 months||||units on a scale||Standard Error|Least Squares Mean
2585383|NCT02345889|Secondary|Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.||During Procedure||||Percentage of Sessile Serrated Polyps|||Number
2585384|NCT02345889|Secondary|Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.||During Procedure||||Sessile Serrated Polyps|||Number
2585385|NCT02345889|Secondary|Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.||During Procedure||||Percentage of Adenomas|||Number
2585386|NCT02345889|Secondary|Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure.||During Procedure||||Adenomas|||Number
2585387|NCT02345889|Secondary|Inspection Time||During Procedure|The mean inspection time of all three sites overall was calculated as well as the mean inspection time for each individual site. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.|||Seconds||Standard Deviation|Mean
2585388|NCT02345889|Secondary|Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion||During Procedure|Gastroenterology fellows were allowed to assist in inserting the scope, but times included in this analysis were from insertions done completely by the physician. This is why the overall number analyzed differs from the number analyzed in other outcome measure as well as why the numbers differ depending on site and randomization arm.|||Seconds||Standard Deviation|Mean
2585389|NCT02345889|Secondary|Cecal Insertion Time||During Procedure|The mean insertion time was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.|||Seconds||Standard Deviation|Mean
2585390|NCT02345889|Secondary|Percentage of Participants With a Detected Polyp||During Procedure|The number of participants analyzed for each site differed because the percentage of patients with a polyp was calculated for each site specifically. Thus, only patients randomized to the treatment arm at that site were included in the calculation instead of including the total number of patients randomized to the treatment arm.|||Percentage of Participants|||Number
2585391|NCT02345889|Secondary|Number of Participants With a Detected Polyp||During Procedure|The number of participants with a detected polyp was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.|||Participants|||Count of Participants
2585392|NCT02345889|Secondary|Percentage of Participants With Detected Sessile Serrated Polyp||During Procedure|The number of participants analyzed for each site differed because the percentage of patients with a sessile serrated polyp was calculated specifically for the site. Thus, only patients randomized to the treatment arm at that site were included in the calculation instead of including the total number of patients randomized to the treatment arm.|||Percentage of Participants|||Number
2585393|NCT02345889|Secondary|Number of Participants With Detected Sessile Serrated Polyp|Number of patients with 1 or more sessile serrated polyps|During Procedure|The number of participants with detected sessile serrated polyps was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.|||Participants|||Count of Participants
2585394|NCT02345889|Secondary|Sessile Serrated Polyps Per Colonoscopy||During Procedure|The number of sessile serrated polyps per colonoscopy was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.|||Sessile Serrated Polyps per colonoscopy||Standard Deviation|Mean
2585395|NCT02345889|Secondary|Percentage of Participants With Detected Adenoma||During Procedure|The number of participants analyzed differed because the calculation was done for all three sites overall and then broken down into each specific site. Thus, only patients randomized to the treatment arm at that site were included in the specific site calculations instead of including the total number of patients randomized to that treatment arm.|||Percentage of Participants|||Number
2585396|NCT02345889|Secondary|Number of Participants With Detected Adenoma||During Procedure|The number of participants with detected adenomas was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.|||Participants|||Count of Participants
2585397|NCT02345889|Primary|Adenomas Per Colonoscopy||During Procedure|The number of adenomas was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization.|||Adenomas per Colonoscopy||Standard Deviation|Mean
2585398|NCT02345772|Secondary|QTA (Quantitative Texture Analysis)|QTA (Quantitative Texture Analysis): will be obtained from baseline mammogram and the correlation with clinical outcome after neoadjuvant therapy will be performed.|One year|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
2587263|NCT02320838|Secondary|Thermal Pain Threshold Post-treatment 20 Min.|The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC|at 20 min. post-treatment||||ºC||Standard Deviation|Mean
2585399|NCT02345772|Secondary|Partial Pathological Response Rate|Partial pathological response rate at the time of surgery and biomarker changes in breast cancer (biopsy vs residual tumor) before and after neoadjuvant chemotherapy Note: pPR, defined as residual invasive disease of 1cm, ypT1a-b.|One Year|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
2585400|NCT02345772|Primary|Pathological Complete Remission Rate|To determine pathological complete remission rate at the time of surgery in ER-positive and HER2-positive breast cancer patients undergoing neoadjuvant chemoimmunotherapy (docetaxel, trastuzumab, pertuzumab) concurrently with neoadjuvant hormonal therapy with fulvestrant. Note: pCR, defined as the absence of invasive neoplastic cells of the primary tumor in the breast, remaining in-situ lesions are allowed, ypT0-is;|one year|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
2585401|NCT02345720|Primary|Corneal Staining|The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported.|30 Days Post Wear|The analysis population consists of all subjects that were dispensed a study lens.|||percentage of upper corneal quadrant||Standard Deviation|Mean
2585402|NCT02345720|Primary|Limbal Staining|Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported.|30 Days Post Wear|The analysis population consist of all subjects that were dispensed a study lens.|||percentage of limbal area||Standard Deviation|Mean
2585403|NCT02345720|Primary|Upper Eye Lid Margin Staining|Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm^2.|30 days Post wear|The analysis population consists of all subjects that were dispensed a study lens.|||mm^2||Standard Deviation|Mean
2585404|NCT02345642|Primary|Peak Venous Velocity|Ultrasound of the venous system just below the saphenofemoral junction to assess the venous velocity will be taken before and after application the VenaFlow and the ActiveCare+S.F.T pneumatic compression devices. Change from Baseline in Peak Venous Velocity 30 minutes after Device is applied is recorded.|Change from Baseline in Peak Venous Velocity 30 minutes after Device is Applied||||cm/s||Full Range|Mean
2585405|NCT02345512|Secondary|Number of Participants That Were Compliant With Lycra Splinting Garment Wear|Survey questions to determine usability (compliance) of lycra splinting garment wear for individuals with intellectual disabilities|6 week intervention period|adults with intellectual disabilities who had experienced a fall in the last 12 months|||participants|||Number
2585406|NCT02345512|Primary|Timed Up and Go Test Time|The time taken to complete the Timed Up and Go Test.|6 week intervention period|Adults with intellectual disabilities with gait or balance issues who have fallen at least once in the previous 12 months|||s||Full Range|Mean
2585407|NCT02345512|Primary|Double Support Time as a Percentage of the Gait Cycle|Percentage of the gait cycle where both feet are on the ground together.|6 week intervention period|Adults with intellectual disabilities with gait or balance issues who have fallen at least once in the previous 12 months|||percentage of the gait cycle||Full Range|Mean
2585408|NCT02345512|Primary|Step Symmetry|The symmetry was calculated as the ratio between the longest and shortest of the left and right step lengths. This provides an indication of the level of symmetry between sides. A score of 1 indicates complete symmetry with values less than one becoming progressively less symmetrical.|6 week intervention period|Adults with intellectual disabilities with gait or balance issues who have fallen at least once in the previous 12 months|||ratio||Full Range|Mean
2585409|NCT02345512|Primary|Base of Support|Width between heel strikes perpendicular to direction of travel|6 week intervention period|Adults with Intellectual Disabilities with Gait or Balance Issues who Fall|||m||Full Range|Mean
2585410|NCT02345512|Primary|Step Length|Distance from initial foot contact on one side to initial foot contact on contralateral side.|6 week intervention period|Adults with intellectual disabilities with gait or balance issues who have fallen in previous 12 months|||m||Full Range|Mean
2585411|NCT02345512|Primary|Walking Speed|The walking speed along a standardised walking mat.|6 week intervention period|Adults with intellectual disabilities with balance or gait issues who fall|||m/s||Full Range|Mean
2585412|NCT02345512|Primary|Center of Pressure Standard Deviation|The standard deviation of the Center of Pressure during quiet standing. The standard deviation of this measure is used as the outcome as it is the dispersion of the location of the centre of pressure that is of interest.|6 week intervention period|Adults with intellectual disabilities with gait or balance issues who have experienced a fall in previous 12 months|||mm||Full Range|Mean
2585413|NCT02345512|Primary|Falls|Self-report fall calendar completed daily during the 6-week intervention period|6 weeks|Adults with Intellectual Disabilities with gait issues who experienced a fall within the last 12 months|||Falls||Full Range|Mean
2585414|NCT02345486|Secondary|Peak Creatinine in the First 30 Days|Highest creatinine value in the first 30 days|30 days||||mg/dL||Inter-Quartile Range|Median
2585415|NCT02345486|Secondary|Dialysis-free Survival to Day 28|Dialysis free survival to day 28 will be defined as the number of days alive and without dialysis receipt to day 28 after enrollment, assuming a patient survives for at least two consecutive calendar days after last receipt of dialysis and remains free of dialysis. If the patient is receiving dialysis at day 28 or dies prior to day 28, VFD will be 0.|28 days||||days||Inter-Quartile Range|Median
2585416|NCT02345486|Secondary|Ventilator-free Days (VFD) to Day 28|Ventilator-free days to day 28 will be defined as the number of days alive and with unassisted breathing to day 28 after enrollment, assuming a patient survives for at least two consecutive calendar days after initiating unassisted breathing and remains free of assisted breathing. If a patient returns to assisted breathing and subsequently achieves unassisted breathing prior to day 28, VFD will be counted from the end of the last period of assisted breathing to day 28. If the patient is receiving assisted ventilation at day 28 or dies prior to day 28, VFD will be 0.|28 days||||days||Inter-Quartile Range|Median
2585417|NCT02345486|Secondary|Intensive Care Unit Free Days to Day 28|ICU-free days to 28 days after enrollment will be defined as the number of days alive and not admitted to an intensive care unit service after the patient's final discharge from the intensive care unit before 28 days. If the patient is admitted to an intensive care unit service at day 28 or dies prior to day 28, ICU-free days will be 0.|28 days||||days||Inter-Quartile Range|Median
2585418|NCT02345486|Secondary|Incidence of Acute Kidney Injury|Incidence of stage II or III acute kidney injury by Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury criteria, censored at 30 days|30 days||||Participants|||Count of Participants
2585419|NCT02345486|Secondary|Increase in Serum Creatinine|Increase in serum creatinine during hospitalization, censored at 30 days Change from baseline to highest value, median (IQR), mg/dl|30 days||||mg/dL||Inter-Quartile Range|Median
2585420|NCT02345486|Secondary|Incidence of Severe Hypochloremia|Incidence of severe hypochloremia defined as a serum chloride less than 90mmol/L|30 days||||Participants|||Count of Participants
2585421|NCT02345486|Secondary|Incidence of Hyperchloremia|Incidence of hyperchloremia defined as a serum chloride greater than or equal to 110 mmol/L|30 days||||Participants|||Count of Participants
2585422|NCT02345486|Secondary|Number of Contraindications|Number of contraindications to assigned study fluid identified by providers, censored at 30 days|30 days|Order for intravenous crystalloid is the unit analyzed; each patient could have multiple orders for intravenous crystalloid|||Orders for intravenous crystalloid|Orders for intravenous crystalloid||Count of Units
2585423|NCT02345486|Secondary|Persistent Renal Dysfunction|Persistence of renal dysfunction at hospital discharge or at 30 days (defined as an increase in serum creatinine ≥ 200% from baseline)|30 days||||Participants|||Count of Participants
2585424|NCT02345486|Secondary|New Use of Renal Replacement Therapy|Receipt of new renal replacement therapy after the first study day, censored at 30 days|30 days||||Participants|||Count of Participants
2585425|NCT02345486|Secondary|In-hospital Mortality|Death prior to the earlier of hospital discharge or day 30|30 days||||Participants|||Count of Participants
2585426|NCT02345486|Secondary|Number of Patients With MAKE30|Incidence of Major Adverse Kidney Events by 30 days -- a composite outcome defined as one or more of the following: death, new use of renal replacement therapy, or persistence of renal dysfunction at hospital discharge or at 30 days (defined as an increase in serum creatinine ≥ 200% from baseline)|30 days||||Participants|||Count of Participants
2585427|NCT02345486|Secondary|Lowest Bicarbonate Concentration Between Enrollment and Day 30|Lowest serum bicarbonate concentration (mmol/L) during admission to the intensive care unit, censored at 30 days|30 days||||mmol/L||Inter-Quartile Range|Median
2585428|NCT02345486|Secondary|Highest Serum Sodium Between Enrollment and Day 30|Highest serum sodium concentration (mmol/L) during admission to the intensive care unit, censored at 30 days|30 days||||mmol/L||Inter-Quartile Range|Median
2585429|NCT02345486|Secondary|Highest Serum Chloride Between Enrollment and Day 30|highest serum chloride (mmol/L) during admission to the intensive care unit, censored at 30 days|30 days||||mmol/L||Inter-Quartile Range|Median
2585430|NCT02345486|Secondary|Total Intravenous Blood Product Administration|Total volume of packed red blood cells, platelets, and fresh frozen plasma administered during admission to the intensive care unit, censored at 30 days|30 days||||milliliters||Inter-Quartile Range|Median
2585431|NCT02345486|Secondary|Total Intravenous Colloid Input|Total volume of intravenous colloid administration (excluding blood products) during admission to the intensive care unit, censored at 30 days|30 days||||milliliters||Inter-Quartile Range|Median
2585432|NCT02345486|Secondary|Total Isotonic Crystalloid Input|Total volume of intravenous isotonic crystalloid administration during admission to the intensive care unit, censored at 30 days|30 days||||mL||Inter-Quartile Range|Median
2585433|NCT02345486|Secondary|Total Intravenous Input|Total volume of intravenous fluid administration during admission to the intensive care unit, censored at 30 days|30 days||||milliliters||Inter-Quartile Range|Median
2585434|NCT02345486|Secondary|Proportion of Isotonic Crystalloid Which is Physiologically Balanced|Proportion of total intravenous isotonic crystalloid administered during admission to the intensive care unit that is either Lactated ringers or Plasmalyte-A, censored at 30 days.|30 days||||Percentage of fluid that was balanced||Full Range|Mean
2585435|NCT02345486|Primary|Proportion of Isotonic Crystalloid Which is 0.9% Saline|Proportion of total intravenous isotonic crystalloid administered during admission to the intensive care unit that is 0.9% sodium chloride, censored at 30 days. The primary outcome was the proportion of intravenous isotonic crystalloid administered in the ICU that was saline. This was a continuous variable calculated for each patient as the volume of saline received divided by volume of saline received plus volume of balanced crystalloids received with a range from 0.0 (no saline received) to 1.0 (only saline received).|30 days||||Percentage of fluid that was saline||Full Range|Mean
2585436|NCT02345460|Secondary|Number of Participants Experiencing Perioperative (30-day) Mortality|Will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes.|Up to 30 days|Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.||||||
2585437|NCT02345460|Secondary|Number of Participants Achieving R0 Resection|Will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes.|Up to 2 years|Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.||||||
2585438|NCT02345460|Secondary|Number of Participants Achieving Major Pathologic Response|Will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes.|Up to 2 years|Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.||||||
2585439|NCT02345460|Secondary|Response Rate Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1|Will be calculated as a binary outcome. Exact 95% confidence intervals will be calculated for binary outcomes.|Up to 2 years|Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.||||||
2585440|NCT02345460|Secondary|Incidence of Toxicities Greater Than Grade 2, Using the Common Terminology Criteria for Adverse Events Version 4.0|Toxicity evaluation will be enumeration of all major toxicities, with proportions calculated for each.|Up to 30 days after end of treatment or to the day prior to surgery|Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.||||||
2585441|NCT02345460|Secondary|Overall Survival|Time from enrollment to death from any cause. Will be estimated with Kaplan Meier curves.|Up to 2 years|Only 1 patient was enrolled on study. Outcome data was not analyzed.||||||
2587264|NCT02320838|Secondary|Baseline Thermal Pain Threshold|The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC|Baseline at 0 min.||||ºC||Standard Deviation|Mean
2585442|NCT02345460|Secondary|Progression-free Survival|Time from enrollment to the earlier of death or disease progression. Will be estimated with Kaplan Meier curves.|Up to 2 years|Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.||||||
2585443|NCT02345460|Primary|Number of Patients Undergoing Surgical Resection After Receiving at Least 4 of the 6 Courses of Preoperative Chemotherapy|Proportion will be estimated using a binomial test.|Up to 12 weeks|Only 1 patient was enrolled on study. Outcome data was not analyzed. Trial closed due to competing studies.||||||
2585444|NCT02345369|Secondary|Harris Hip Score|Subjective outcome scores (modified Harris hip score) will be collected at 3 and 6 months after surgery.|6 months|no outcomes to report||||||
2585445|NCT02345369|Secondary|Time to Radiographic Union|Time to radiographic union and any occurrence of hardware failure, nonunion and malunion will be noted|6 months|no outcomes to report||||||
2585446|NCT02345369|Primary|Femoral Neck Shortening|Femoral neck shortening will be measured radiographically with femoral neck offset and the femoral neck shaft angle to be measured radiographically based on standardized computerized measurements based off of PACs images. TraumaCad software (Voyanthealth, Westchester, Il) will be utilized to obtain standardized measurements.|6 months|no outcomes to report||||||
2585447|NCT02345330|Secondary|Median Overall Survival (OS)|Overall survival is defined as the time in days from the date of first study drug administration to the date of death.|From the start of study treatment until death|Due to early termination of the study overall survival data was not collected and reported.||||||
2585448|NCT02345330|Secondary|Median Time to Progression (TTP)|TTP is defined as the number of days between the treatment initiation date (Study Day 1) and the earliest date of documented disease progression as defined by RECIST 1.1 or death that is not associated with prior disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From start of study treatment weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)|Due to early termination of the study TTP data was not collected and reported.||||||
2585449|NCT02345330|Secondary|Median Progression Free Survival (PFS)|Progression free survival (PFS) time is defined as the duration between the date of treatment initiation (Study Day 1) to the first date of either disease progression at either local or any distant sites, or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients were censored at their date of last assessment, if they were alive and without evidence of disease progression.|From start of study treatment weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)|Due to early termination of the study PFS data was not collected and reported.||||||
2585450|NCT02345330|Secondary|Regression Rate of Treated and Untreated Lesions|The treated (injected, electroporated) lesion regression rate is defined as the percentage of patients who had at least one treated lesion that decreased in longest dimension by ≥ 30%. The untreated (non-injected, non-electroporated) lesion regression rate is defined as the percentage of patients who had at least one untreated lesion that decreased in longest dimension by ≥ 30%.|Every 6 weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)|Due to early termination of the study regression rate data was not collected and reported.||||||
2585451|NCT02345330|Secondary|Best Overall Response Rate (BORR) by Immune-related Response Criteria (irRC)|BORR is defined as the percentage of participants with evaluable lesions that achieved a complete response (CR) or partial response (PR) as assessed by the investigator using irRC criteria. CR: complete disappearance of all lesions (whether measurable or not) and the absence of new lesions for at least 4 weeks duration, confirmed by additional scan and visit 4 to 6 weeks after first documentation of CR. PR: ≥50% decrease in the product of the diameters from baseline.|Every 6 weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)|Due to early termination of the study BORR by irRC data was not collected and reported.||||||
2585452|NCT02345330|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, medical treatment or procedure and which did not necessarily have to have had a causal relationship with this treatment. An adverse event could have, therefore, been any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, medical treatment or procedure whether or not considered related to the medicinal product. An SAE was defined an any untoward medical occurrence that at any dosage resulted in one or more of the following: death, A life-threatening adverse event (real risk of dying), inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly, required intervention to prevent permanent impairment of damage.|From first study treatment to 30 days after the last study treatment (up to 14.5 months)|All enrolled participants.|||Participants|||Count of Participants
2585453|NCT02345330|Primary|Best Overall Response Rate (BORR) by RECIST v1.1|BORR is defined as the percentage of participants with evaluable lesions that achieved a complete response (CR) or partial response (PR) as assessed by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.|Every 6 weeks until disease progression, death, withdrawal of consent or study termination (up to 14.5 months)|Due to early termination of the study BORR by RECIST v1.1 data was not collected and reported.||||||
2585454|NCT02345252|Secondary|Percent Change From Baseline in Spine BMD at Week 96|Spine BMD was assessed by DXA scan.|Baseline; Week 96|Participants in the Spine DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2585455|NCT02345252|Secondary|Percent Change From Baseline in Spine BMD at Week 48|Spine BMD was assessed by DXA scan.|Baseline; Week 48|Participants in the spine DXA Analysis Set (all randomized participants who received at least 1 dose of study drug, and had nonmissing baseline hip BMD value) with available data were analyzed.|||percentage change||Standard Deviation|Mean
2585457|NCT02345252|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline; Week 48|Participants in the Hip DXA Analysis Set (all randomized participants who received at least 1 dose of study drug, and had nonmissing baseline hip BMD value) with available data were analyzed.|||percentage change||Standard Deviation|Mean
2585458|NCT02345252|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with on-treatment data were analyzed.|||cells/µL||Standard Deviation|Mean
2585459|NCT02345252|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with on-treatment data were analyzed.|||cells/µL||Standard Deviation|Mean
2585460|NCT02345252|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2585461|NCT02345252|Secondary|Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2585462|NCT02345252|Secondary|Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2585463|NCT02345252|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the US FDA-defined snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug and were on FTC/RPV/TDF prior to the screening visit.|||percentage of participants|||Number
2585464|NCT02345226|Secondary|Change From Baseline in HIVSI Score at Week 96|The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing.|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2585465|NCT02345226|Secondary|Change From Baseline in HIV Symptoms Index Score (HIVSI) at Week 48|The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don't have this symptom; 1 = It doesn't bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing.|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2585466|NCT02345226|Secondary|Percent Change From Baseline in Spine BMD at Week 96|Spine BMD was assessed by DXA scan.|Baseline; Week 96|Participants in the Spine DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2585467|NCT02345226|Secondary|Percent Change From Baseline in Spine BMD at Week 48|Spine BMD was assessed by DXA scan.|Baseline; Week 48|Participants in the Spine DXA Analysis Set (all randomized participants, received at least 1 dose of study drug, and had nonmissing baseline spine BMD values) with available data were analyzed.|||percentage change||Standard Deviation|Mean
2585468|NCT02345226|Secondary|Percent Change From Baseline in Hip BMD at Week 96|Hip BMD was assessed by DXA scan.|Baseline; Week 96|Participants in the Hip DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2585469|NCT02345226|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline; Week 48|Participants in the Hip DXA Analysis Set (all randomized participants received at least 1 dose of study drug, and had nonmissing baseline hip BMD value) with available data were analyzed.|||percentage change||Standard Deviation|Mean
2585470|NCT02345226|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with on-treatment data were analyzed.|||cells/µL||Standard Deviation|Mean
2585471|NCT02345226|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with on-treatment data were analyzed.|||cells/µL||Standard Deviation|Mean
2585646|NCT02342743|Secondary|Change in Frequency of Headache Episodes|Mean change in frequency of headache episodes (defined as a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment.|End of baseline period and end of 12 weeks treatment period||||episodes per 28-days||Standard Deviation|Mean
2585472|NCT02345226|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-defined Snapshot|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2585473|NCT02345226|Secondary|Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Defined by the US FDA-defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2585474|NCT02345226|Secondary|Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2585475|NCT02345226|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-defined Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug and were on EFV/FTC/TDF prior to the screening visit.|||percentage of participants|||Number
2585476|NCT02345161|Secondary|Number of Participants With at Least One On-treatment Bone Fracture Incident in the Extension Part of the Study|To evaluate the potential for bone systemic corticosteroid effects, the incidence of bone fractures was assessed. It was categorized as an adverse event of special interest.|Up to Week 52|Extension Population|||Participants|||Number
2585477|NCT02345161|Secondary|Number of Participants With at Least One On-treatment Bone Fracture Incident in the Treatment Period|To evaluate the potential for bone systemic corticosteroid effects, the incidence of bone fractures was assessed. It was categorized as an adverse event of special interest.|Up to Week 24|ITT Population|||Participants|||Number
2585478|NCT02345161|Secondary|Number of Participants Reporting an AESI of Oropharyngeal Origin in the Extension Part of the Study|Oropharyngeal examinations for clinical evidence of infection (e.g., Candida albicans) were performed at each clinic visit. All suspected cases of candidiasis were reported as AEs. The number of participants with oral candidiasis, candida infection, oral fungal infection, and oropharyngeal candidiasis were reported.|Up to Week 52|Extension Population|||Participants|||Number
2585479|NCT02345161|Secondary|Number of Participants Reporting an Adverse Event of Special Interest (AESI) of Oropharyngeal Origin in the Treatment Period|Oropharyngeal examinations for clinical evidence of infection (e.g., Candida albicans) were performed at each clinic visit. All suspected cases of candidiasis were reported as AEs. The number of participants with oral candidiasis, Candida infection, oral fungal infection, and oropharyngeal candidiasis were reported.|Up to Week 24|ITT Population|||Participants|||Number
2585480|NCT02345161|Secondary|Change From Baseline in Bilirubin, Creatinine, and Urate at Week 52|Blood samples were collected for the measurement of bilirubin, creatinine, and urate at Baseline, Week 12, Week 24, and Week 52 of the extension part of the study. Change from Baseline was calculated as the post-Baseline value at Week 52 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat).|Baseline and Week 52|Extension Population|||Micromoles per liter||Standard Deviation|Mean
2585481|NCT02345161|Secondary|Change From Baseline in Bilirubin, Creatinine, and Urate at Week 24|Blood samples were collected for the measurement of bilirubin, creatinine, and urate at Baseline, Week 12, and Week 24. Change from Baseline was calculated as the post-Baseline value at Week 24 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 24|ITT Population|||Micromoles per liter||Standard Deviation|Mean
2585482|NCT02345161|Secondary|Change From Baseline in Glucose, Calcium, CO2, Chloride, Magnesium, Phosphate, Potassium, Sodium, and Urea at Week 52|Blood samples were collected for the measurement of Glucose, calcium, CO2, chloride, magnesium, phophate, potassium, sodium, and urea at Baseline, Week 12, Week 24, and Week 52 for the extension part of the study. Change from Baseline was calculated as the post-Baseline value at Week 52 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 52|Extension Population|||Mmol/L||Standard Deviation|Mean
2585483|NCT02345161|Secondary|Change From Baseline in Glucose, Calcium, Carbon Dioxide (CO2), Chloride, Phosphate, Potassium, Sodium, and Urea at Week 24|Blood samples were collected for the measurement of Glucose, calcium, CO2, chloride, phophate, potassium, sodium, and urea at Baseline, Week 12, and Week 24. Change from Baseline was calculated as the post-Baseline value at Week 24 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 24|ITT Population|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2585647|NCT02342743|Secondary|Change in Monthly Cumulative Headache Hours|Mean change in monthly cumulative headache hours on headache days between the 28-day baseline and the 28-day period ending with week 12 of treatment.|End of baseline period and end of 12 weeks treatment period||||hours per 28-days||Standard Deviation|Mean
2596371|NCT02209766|Secondary|Cmax in Plasma Baseline-adjusted Total Eicosapentaenoic Acid (EPA), Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2585484|NCT02345161|Secondary|Change From Baseline in ALT, AST, GGT, ALP, and Creatine Kinase at Week 52|Blood samples were collected for the measurement of ALP, ALT, AST, CK, and GGT at Baseline, Week 12, Week 24 and Week 52 for the extension part of the study. Change from Baseline was calculated as the post-Baseline value at Week 52 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 52|Extension Population|||International units per liter (IU/L)||Standard Deviation|Mean
2585485|NCT02345161|Secondary|Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Aminotransferase (GGT), Alkaline Phosphatase (ALP), and Creatine Kinase at Week 24|Blood samples were collected for the measurement of ALP, ALT, AST, CK, and GGT at Baseline, Week 12 and Week 24. Change from Baseline was calculated as the post-Baseline value at Week 24 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 24|ITT Population|||International units per liter (IU/L)||Standard Deviation|Mean
2585486|NCT02345161|Secondary|Change From Baseline in Albumin and Protein at Week 52|Blood samples were collected for the measurement of albumin and protein at Baseline, Week 12, Week 24, and Week 52 for the extension part of the study. Change from Baseline was calculated as the post-Baseline value at Week 52 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 52|Extension Population|||g/L||Standard Deviation|Mean
2585487|NCT02345161|Secondary|Change From Baseline in Albumin and Protein at Week 24|Blood samples were collected for the measurement of albumin and protein at Baseline, Week 12 and Week 24. Change from Baseline (BL) was calculated as the post-Baseline value at Week 24 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). The maximum post BL values have been presented. Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 24|ITT Population|||g/L||Standard Deviation|Mean
2585488|NCT02345161|Secondary|Change From Baseline in Hematocrit at Week 52|Blood samples were collected for the measurement of hematocrit (proportion of red blood cells in blood) at Baseline, Week 12, Week 24, and Week 52 for the extension part of the study. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as Most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 52|Extension Population|||Fraction of 1||Standard Deviation|Mean
2585489|NCT02345161|Secondary|Change From Baseline in Hematocrit at Week 24|Blood samples were collected for the measurement of hematocrit (proportion of red blood cells in blood) at Baseline, Week 12, and Week 24. Change from Baseline was calculated as the post-Baseline value at Week 24 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 24|ITT Population|||Fraction of 1||Standard Deviation|Mean
2585490|NCT02345161|Secondary|Change From Baseline in Hemoglobin at Week 52|Blood samples were collected for the measurement of hemoglobin at Baseline, Week 12, Week 24, and Week 52 for the extension part of the study. Change from Baseline was calculated as the post-Baseline value at Week 52 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 52|Extension Population|||g/L||Standard Deviation|Mean
2585491|NCT02345161|Secondary|Change From Baseline in Hemoglobin at Week 24|Blood samples were collected for the measurement of hemoglobin at Baseline, Week 12, and Week 24. Change from Baseline was calculated as the post-Baseline value at Week 24 minus the Baseline value. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 24|ITT Population|||Grams per liter (g/L)||Standard Deviation|Mean
2585492|NCT02345161|Secondary|Change From Baseline in Erythrocytes at Week 52|Hematology laboratory assessments included erythrocytes and was measured at Baseline, Week 12 and Week 24, and Week 52 for the extension part of the study. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose value at Week 52. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 52|Extension Population|||10^12 cells/L||Standard Deviation|Mean
2585493|NCT02345161|Secondary|Change From Baseline in Erythrocytes at Week 24|Hematology laboratory assessments included erythrocytes and was measured at Baseline, Week 12 and Week 24. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose value at Week 24. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 24|ITT Population|||10^12 cells/L||Standard Deviation|Mean
2585697|NCT02342314|Secondary|PK: Tmax of Part B||Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||hour||Full Range|Median
2585494|NCT02345161|Secondary|Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 52|Hematology laboratory assessments included Basophils, eosinophils, lymphocytes, monocytes,neutrophils, total neutrophil, leukocytes, and platelets; parameters were measured at Baseline (BL), Week 12, Week 24, and Week 52 for the extension part of the study. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose value at Week 52. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 52|Extension Population|||10^9 cells/L||Standard Deviation|Mean
2585495|NCT02345161|Secondary|Change From Baseline in Basophils, Eosinophils, Monocytes, Neutrophils, Leukocytes, Lymphocytes, and Platelets at Week 24|Hematology laboratory assessments included basophils, eosinophils, lymphocytes, monocytes, neutrophils, total neutrophil, leukocytes, and platelets; parameters were measured at Baseline (BL), Week 12 and Week 24. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose value at Week 24. Baseline was defined as the most recent individual value prior to randomization (generally Screening but could be a repeat test). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). The maximum post-Baseline values have also been presented.|Baseline and Week 24|ITT Population|||10^9 cells/Liter(L)||Standard Deviation|Mean
2585496|NCT02345161|Secondary|Change From Baseline in Pulse Rate at Week 52|Pulse rate was obtained at the Screening Visit and prior to taking the morning dose of study treatment and prior to conducting spirometry at Week 4, Week 24, and Week 52 or at the Study Treatment Discontinuation. Pulse rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from Baseline values for pulse rate at Week 52 were summarized and these data were analyzed using MMRM analysis. Baseline was defined as the values from most recent assessment prior to randomization (generally Screening but could be a test repeat).|Baseline and Week 52|Extension Population; Only participants with analyzable data at the given time point were analyzed.|||Bpm||Standard Error|Least Squares Mean
2585497|NCT02345161|Secondary|Change From Baseline in Pulse Rate at Week 24|Pulse rate was obtained at the Screening Visit and prior to taking the morning dose of study treatment and prior to conducting spirometry at Week 4 and Week 24 or at the Study Treatment Discontinuation. Pulse rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from Baseline values for pulse rate at Week 24 were summarised and these data were analyzed using MMRM analysis. Baseline was defined as the values from most recent assessment prior to randomization (generally Screening but could be a test repeat).|Baseline and Week 24|ITT Population; Only participants with analyzable data at the given time point were analyzed.|||Bpm||Standard Error|Least Squares Mean
2585498|NCT02345161|Secondary|Number of Participants With Any Abnormal Holter Electrocardiogram (ECG) Finding at Week 24|The 24-hour holter measurements were obtained at Screening and 24 hours prior to Week 24 (Visits 1 and 6). The number of participants with clinically significant change (abnormal) were reported. Holter Monitoring Population: all participants in the ITT Population who had at least one holter monitoring evaluation.|Up to Week 24|Holter Monitoring Population; Only participants with analyzable data at the given time point were analyzed.|||Participants|||Number
2585499|NCT02345161|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressures (BP) at Week 52|Vital signs were obtained at the Screening Visit and prior to taking the morning dose of study treatment and prior to conducting spirometry at Week 4, Week 24, and Week 52 or at the Study Treatment Discontinuation Visit. A single set of blood pressure (systolic and diastolic) measurements were taken after the participant had rested for 5 minutes in the sitting position. Change from Baseline values for systolic and diastolic BP (SBP and DBP) at Week 52 were summarised and these data were analyzed using MMRM analysis. Baseline was defined as the values from most recent assessment prior to randomization which records both systolic and diastolic BP (generally Screening but could be a test repeat).|Baseline and Week 52|Extension Population; Only participants with analyzable data at the given time point were analyzed.|||mmHg||Standard Error|Least Squares Mean
2585500|NCT02345161|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressures (BP) at Week 24|Vital signs were obtained at the Screening Visit and prior to taking the morning dose of study treatment and prior to conducting spirometry at Week 4 and Week 24 or at the Study Treatment Discontinuation Visit. A single set of blood pressure (systolic and diastolic) measurements were collected taken after the participant had rested for 5 minutes in the sitting position. Change from Baseline values for systolic and diastolic BP (SBP and DBP) at Week 24 were summarised and these data were analyzed using MMRM analysis. Baseline was defined as the values from most recent assessment prior to randomization which records both systolic and diastolic BP (generally Screening but could be a test repeat).|Baseline and Week 24|ITT Population; Only participants with analyzable data at the given time point were analyzed.|||Millimeter of mercury (mmHg)||Standard Error|Least Squares Mean
2585501|NCT02345161|Secondary|Change From Baseline in QTcB at Week 52|A single 12-lead ECG and rhythm strip were recorded after measurement of vital signs and spirometry. Recordings were made at Screening (Visit 1) and approximately 15-45 minutes after dosing on treatment Week 4, Week 24, and Week 52 or IP Discontinuation Visit. Change from Baseline in QTcB was summarized for each post-Baseline assessment up to Week 52. Change from Baseline was calculated as the individual post-Baseline value at Week 52 minus the Baseline value. Baseline value is defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). All ECG measurements were made with the participants in a supine position having rested in this position for approximately 5 minutes before each reading.|Baseline and Week 52|Extension Population; Only participants with analyzable data at the given time point were analyzed.|||Msec||Standard Deviation|Mean
2585509|NCT02345161|Secondary|Number of Participants With an On-treatment Penumonia Event in the Extension Part of the Study|All suspected pneumonias required confirmation as defined by the presence of new infiltrate(s) on chest x-ray AND at least 2 of the following signs and symptoms: Increased cough, Increased sputum purulence (colour) or production, Auscultatory findings of adventitious sounds , Dyspnea or tachypnea, Fever (oral temperature > 37.5 °C), Elevated WBC (>10,000/mm3 or >15 percent immature forms) orr Hypoxemia (HbO2 saturation <88 percent or at least 2 percent lower than Baseline value).|Up to Week 52|Extension Population|||Participants|||Number
2585502|NCT02345161|Secondary|Change From Baseline in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB) at Week 24|A single 12-lead ECG and rhythm strip were recorded after measurement of vital signs and spirometry. Recordings were made at Screening (Visit 1) and approximately 15-45 minutes after dosing on treatment Week 4 and Week 24 or IP Discontinuation Visit. Change from Baseline in QTcB was summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value at Week 24 minus the Baseline value. Baseline value is defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). All ECG measurements were made with the participants in a supine position having rested in this position for approximately 5 minutes before each reading.|Baseline and Week 24|ITT Population; Only participants with analyzable data at the given time point were analyzed.|||Msec||Standard Deviation|Mean
2585503|NCT02345161|Secondary|Change From Baseline in QTcF and PR Interval at Week 52|Single 12-lead ECG and rhythm strip were recorded after measurement of vital signs and spirometry. Recordings were made at Screening (Visit 1) and approximately 15-45 minutes after dosing on treatment Week 4, Week 24 and Week 52 or IP Discontinuation Visit. Change from Baseline in ECG QTcF and PR interval was summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value at Week 52 minus the Baseline value. Baseline value is defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title).|Baseline and Week 52|Extension Population|||Msec||Standard Error|Least Squares Mean
2585504|NCT02345161|Secondary|Change From Baseline in Corrected QT Interval Using Fridericia's Correction (QTcF) and PR Interval at Week 24|A single 12-lead ECG and rhythm strip were recorded after measurement of vital signs and spirometry. Recordings were made at Screening (Visit 1) and approximately 15-45 minutes after dosing on treatment Week 4 and Week 24 or IP Discontinuation Visit. Change from Baseline in ECG QTcF and PR interval was summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value at Week 24 minus the Baseline value. Baseline value is defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title). All ECG measurements were made with the participants in a supine position having rested in this position for approximately 5 minutes before each reading.|Baseline and Week 24|ITT population|||Milliseconds (msec)||Standard Error|Least Squares Mean
2585505|NCT02345161|Secondary|Change From Baseline in Heart Rate at Week 52|A single 12-lead ECG and rhythm strip were recorded after measurement of vital signs and spirometry. Recordings were made at Screening (Visit 1) and approximately 15-45 minutes after dosing on treatment Week 4, Week 24 and Week 52 or IP Discontinuation Visit. Change from Baseline in ECG heart rate was summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value at Week 52 minus the Baseline value. Baseline value is defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). All ECG measurements were made with the participants in a supine position having rested in this position for approximately 5 minutes before each reading.|Baseline and Week 52|Extension Population; Only participants with analyzable data at the given time point were analyzed.|||Bpm||Standard Deviation|Mean
2585506|NCT02345161|Secondary|Change From Baseline in Heart Rate at Week 24|A single 12-lead electrocardiogram (ECG) and rhythm strip were recorded after measurement of vital signs and spirometry. Recordings were made at Screening (Visit 1) and approximately 15-45 minutes after dosing on treatment Week 4 and Week 24 or IP Discontinuation Visit. Change from Baseline in ECG heart rate was summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value at Week 24 minus the Baseline value. Baseline value is defined as the most recent individual value prior to randomization (generally Screening but could be a test repeat). All ECG measurements were made with the participants in a supine position having rested in this position for approximately 5 minutes before each reading.|Baseline and Week 24|ITT Population; Only participants with analyzable data at the given time point were analyzed.|||Beats per minute (Bpm)||Standard Deviation|Mean
2585507|NCT02345161|Secondary|Number of Participants With Any On-treatment CV Events (Including Supraventricular Arrhythmia and Non Fatal Myocardial Infarction) in the Extension Part of the Study|Cardiovascular safety was monitored via AE reporting with categorization and analysis of adverse events of special interest (AESIs) including cardiac arrhythmia, cardiac failure, ischemic heart disease, hypertension, and central nervous system hemorrhages and cerebrovascular conditions. In addition, ECGs and vital signs were measured in all subjects and24-hour Holter monitoring was performed in a predefined subset. Pre-specified MACE analysis was conducted based on adjudicated CV deaths and investigator-reported non-fatal AEs. Number of participants with any of the following MACE events were to be included per the broad and narrow analyses: Broad MACE criteria (ischemic heart disease standardized MedDRA query [SMQ; myocardial infarction SMQ and other ischemic diseases]) and narrow MACE criteria (myocardial infarction [acute myocardial infarction]|Up to Week 52|Extension Population|||Participants|||Number
2585508|NCT02345161|Secondary|Number of Participants With Any On-treatment Cardiovascular (CV) Events (Including Supraventricular Arrhythmia and Non Fatal Myocardial Infarction) in the Treatment Period|Cardiovascular safety was monitored via AE reporting with categorization and analysis of adverse events of special interest (AESIs) including cardiac arrhythmia, cardiac failure, ischemic heart disease, hypertension, and central nervous system hemorrhages and cerebrovascular conditions. In addition, ECGs and vital signs were measured in all subjects and24-hour Holter monitoring was performed in a predefined subset. Pre-specified MACE analysis was conducted based on adjudicated CV deaths and investigator-reported non-fatal AEs. Number of participants with any of the following MACE events were to be included per the broad and narrow analyses: Broad MACE criteria (ischemic heart disease standardized MedDRA query [SMQ; myocardial infarction SMQ and other ischemic diseases]) and narrow MACE criteria (myocardial infarction [acute myocardial infarction].|Up to Week 24|ITT Population|||Participants|||Number
2585648|NCT02342743|Secondary|Change in Frequency of Moderate/Severe Headache Days|Mean change in frequency of moderate/severe headache days (defined as a headache day with at least one headache episode with intensity = 2 or 3) between the 28-day baseline and the 28-day period ending with week 12 of treatment.|End of baseline period and end of 12 weeks treatment period||||days per 28-days||Standard Deviation|Mean
2585510|NCT02345161|Secondary|Number of Participants With an On-treatment Penumonia Event in the Treatment Period|All suspected pneumonias required confirmation as defined by the presence of new infiltrate(s) on chest x-ray and at least 2 of the following signs and symptoms: Increased cough, Increased sputum purulence (colour) or production, Auscultatory findings of adventitious sounds , Dyspnea or tachypnea, Fever (oral temperature > 37.5 °C), Elevated white blood cells (WBC) (>10,000/millimeter [mm^3] or >15 percent immature forms) or Hypoxemia (hemoglobin/oxygen [HbO2] saturation <88 percent or at least 2 percent lower than Baseline value).|Up to Week 24|ITT Population.|||Participants|||Number
2585511|NCT02345161|Secondary|Number of Participants With Any On-treatment AE/SAEs in the Extension Part of the Study|An AE was any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. These included an exacerbation of a chronic or intermittent pre-existing condition. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; or all events of possible drug-induced liver injury. Abnormal and clinically significant laboratory test results were also recorded as an AE or SAE. COPD exacerbations were an expected disease-related outcome and were not to be recorded as an AE, unless they met the definition of an SAE. Participants were not to be withdrawn from the study due to COPD exacerbations and their evaluation was an efficacy endpoint.|Up to Week 52|Extension Population|||Participants|||Number
2585512|NCT02345161|Secondary|Number of Participants With Any On-treatment Adverse Event (AE) and Serious Adverse Event (SAE) in the Treatment Period|An AE was any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. These included an exacerbation of a chronic or intermittent pre-existing condition. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; or all events of possible drug-induced liver injury. Abnormal and clinically significant laboratory test results were also recorded as an AE or SAE. COPD exacerbations were an expected disease-related outcome and were not to be recorded as an AE, unless they met the definition of an SAE. Participants were not to be withdrawn from the study due to COPD exacerbations and their evaluation was an efficacy endpoint.|Up to Week 24|ITT Population|||Participants|||Number
2585513|NCT02345161|Secondary|Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean EXACT-RS Scores up to Week 52|The EXACT-PRO is a 14 item instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. EXACT-RS consists of 11 items from the 14 item EXACT-PRO instrument and has a scoring range of 0-40. Three subscales are used to describe different symptoms; dyspnoea (range 0-17), cough and sputum (range 0-11) and chest symptoms (range 0-12). Baseline was defined as the mean value during the period between Visits 1 and 2. Mean scores were calculated for each four weekly period and change from Baseline was calculated as four weekly score minus the Baseline value. Four weekly intervals were analyzed using a MMRM method with covariates of treatment group, smoking status (screening), geographical region, time period, baseline, baseline by time period and treatment by time period interactions. Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title).|Baseline to Week 52|Extension Population|||Scores on a scale||Standard Error|Least Squares Mean
2585514|NCT02345161|Secondary|Assessment of Respiratory Symptoms by Change From Baseline in 4-weekly Mean Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-RS Scores up to Week 24|The EXACT-PRO is a 14 item instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. EXACT-RS consists of 11 items from the 14 item EXACT-PRO instrument and has a scoring range of 0-40. Three subscales are used to describe different symptoms; dyspnoea (range 0-17), cough and sputum (range 0-11) and chest symptoms (range 0-12). Baseline was defined as the mean value during the period between Visits 1 and 2. Mean scores were calculated for each four weekly period and change from Baseline was calculated as four weekly score minus the Baseline value. Four weekly intervals were analyzed using a MMRM method with covariates of treatment group, smoking status (screening), geographical region, time period, baseline, baseline by time period and treatment by time period interactions. Only participants with data available at the analysis time point were analyzed (represented as n=X, X in category title).|Baseline to Week 24|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2585515|NCT02345161|Secondary|Mean Annual On-treatment Moderate and/or Severe COPD Exacerbations up to Week 52|The mean annual moderate and severe COPD exacerbations during the treatment (trt) period (per participant [par.] per year) was assessed. The event rate for exacerbations was calculated as the number of events x 1000 divided by the total participant exposure during the time-period of interest. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. Analysis performed using a generalised linear model assuming a negative binomial distribution and covariates of treatment group, exacerbation history (0, 1, >=2 moderate/severe), smoking status (screening), geographical region and post-bronchodilator percent predicted FEV1 (day 1).|Up to Week 52|Extension Population; Only participants with analyzable data at the given time point were analyzed.|||Exacerbations per participant per year||95% Confidence Interval|Mean
2585538|NCT02344576|Secondary|Changes in Patient Treatment Status (Medical Record Review (Patients Only)|Medical record review (patients only): Treatment received by 6 months, below numbers reported as number of participants who received an LVAD.|6 Month Follow-Up|"Medical record data was collected for patient participants only; does not apply to the Caregiver arm. Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in medical record data analysis, as this data was collected in surveys."|||Participants|||Count of Participants
2585698|NCT02342314|Secondary|PK: Time to Maximum Drug Concentration (Tmax) of Part A||Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||hour||Full Range|Median
2585516|NCT02345161|Secondary|Mean Annual On-treatment Moderate and/or Severe COPD Exacerbations up to Week 24|The mean annual moderate and severe COPD exacerbations during the treatment (trt) period (per participant [par.] per year) was assessed. The event rate for exacerbations was calculated as the number of events x 1000 divided by the total participant exposure during the time-period of interest. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence [color]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. Analysis performed using a generalised linear model assuming a negative binomial distribution and covariates of treatment group, exacerbation history (0, 1, >=2 moderate/severe), smoking status (screening), geographical region and post-bronchodilator percent predicted FEV1 (day 1).|Up to Week 24|ITT Population; Only participants with analyzable data at the given time point were analyzed.|||Exacerbations per participant per year||95% Confidence Interval|Mean
2585517|NCT02345161|Secondary|Daily Activity Question Percentage of Days Reporting a Score of 2 up to Week 52|Participants were asked to complete the daily activity question as aprt of the eDiary, which included the following options: 0: fewer activities, 1: no affect on my activities, and 2: more activities than usual. Daily activity question percentage of days with score of 2 over Weeks 1-24 was analysed using an ANCOVA model with covariates of treatment group, smoking status (screening), geographical region and baseline.|Up to Week 52|Extension Population; Only participants with analyzable data at the given time point were analyzed.|||Percentage of days||Standard Error|Least Squares Mean
2585518|NCT02345161|Secondary|Daily Activity Question Percentage of Days Reporting a Score of 2 up to Week 24|Participants were asked to complete the daily activity question as part of the eDiary, which included the following options: 0: fewer activities, 1: no affect on my activities, and 2: more activities than usual. Daily activity question percentage of days with score of 2 over Weeks 1-24 was analysed using an ANCOVA model with covariates of treatment group, smoking status (screening), geographical region and baseline.|Up to Week 24|ITT Population; Only participants with analyzable data at the given time point were analyzed.|||Percentage of days||Standard Error|Least Squares Mean
2585519|NCT02345161|Secondary|Transitional Dyspnea Index (TDI) Focal Score Expressed as Least Square Mean at Week 52|The TDI measures change in the participant's dyspnoea from Baseline. The scores in both indexes depend on ratings for three different categories: functional impairment; magnitude of task; and magnitude of effort. Each of these scales had a possible score ranging from -6 (major deterioration) to +6 (major improvement). TDI focal score was calculated as the sum of the three individual scores and then divided by 2 (so the range of the TDI focal score is -9 to +9). TDI was measured at Weeks 4, 24 and 52. Analysis performed using a repeated measures model with covariates of treatment group, smoking status (screening), geographical region, visit, BDI focal score, BDI focal score by visit and treatment by visit interactions|Week 52|Extension Population; Only participants with analyzable data at the given time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2585520|NCT02345161|Secondary|Transitional Dyspnea Index (TDI) Focal Score Expressed as Least Square Mean at Week 24|The TDI measures change in the participant's dyspnoea from Baseline. The scores in both indexes depend on ratings for three different categories: functional impairment; magnitude of task; and magnitude of effort. Each of these scales had a possible score ranging from -6 (major deterioration) to +6 (major improvement). TDI focal score was calculated as the sum of the three individual scores and then divided by 2 (so the range of the TDI focal score is -9 to +9). TDI was measured at Week 4 and Week 24. Analysis performed using a repeated measures model with covariates of treatment group, smoking status (screening), geographical region, visit, BDI focal score, BDI focal score by visit and treatment by visit interactions.|Week 24|ITT Population; Only participants with analyzable data at the given time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2585521|NCT02345161|Primary|Change From Baseline in St George's Respiratory Questionnaire-COPD; SGRQ Total Score for COPD Participants at Week 52|The SGRQ-C is a disease-specific questionnaire designed to measure the impact of respiratory disease and its treatment on a COPD participant's health-related quality of life (HRQoL). SGRQ-C total score was converted to SGRQ total score (ranging from 0-100) according to manual. In addition to an overall summary (total) score, scores for the individual domains of Symptoms, Activity, and Impacts (each ranging from 0-100) are produced. A decrease in score indicated improvement in quality of life. The minimum clinically important difference (MCID) for this instrument is a 4-point improvement (decrease from Baseline). Baseline was defined as the value obtained predose on Day 1. Change from Baseline was calculated as total score at Week 52 minus the Baseline value. The analysis for SGRQ total score was performed using a MMRM method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions.|Baseline to Week 52|Extension Population; Only participants with analyzable data at the given time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2585522|NCT02345161|Primary|Change From Baseline in St George's Respiratory Questionnaire-Chronic Obstructive Pulmonary Disease (COPD; SGRQ) Total Score for COPD Participants at Week 24|The SGRQ-C is a disease-specific questionnaire designed to measure the impact of respiratory disease and its treatment on a COPD participant's health-related quality of life (HRQoL). SGRQ-C total score was converted to SGRQ total score (ranging from 0-100) according to manual. In addition to an overall summary (total) score, scores for the individual domains of Symptoms, Activity, and Impacts (each ranging from 0-100) are produced. A decrease in score indicated improvement in quality of life. The minimum clinically important difference (MCID) for this instrument is a 4-point improvement (decrease from Baseline). Baseline was defined as the value obtained predose on Day 1. Change from Baseline was calculated as total score at Week 24 minus the Baseline value. The analysis for SGRQ total score was performed using a MMRM method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions|Baseline to Week 24|ITT Population; Only participants with analyzable data at the given time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2585649|NCT02342743|Secondary|Change in Frequency of Migraine Days|Mean change in frequency of migraine days (any headache day is a migraine day, unless the pain intensity = 1 and there is no intake of acute anti-migraine medication) between the 28-day baseline and the 28-day period ending with week 12 of treatment.|End of baseline period and end of 12 weeks treatment period||||days per 28-days||Standard Deviation|Mean
2585523|NCT02345161|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 52|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 at Week 52 was defined as the FEV1 values obtained prior to morning dose of the study treatment. Baseline was defined as the value obtained predose (0 minutes) on Day 1. Change from Baseline was calculated as the pre-dose measurement at Week 24 minus the Baseline value. The analysis was performed using a mixed model repeated measures (MMRM) method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions. Extension Population: all participants in the ITT Population who were enrolled into the subset of participants with extension to 52 weeks.|Baseline to Week 52|Extension Population; Only participants with analyzable data at the given time point were analyzed.|||Liters (L)||Standard Error|Least Squares Mean
2585524|NCT02345161|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 24|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 at Week 24 was defined as the FEV1 values obtained prior to morning dose of the study treatment. Baseline was defined as the value obtained predose (0 minutes) on Day 1. Change from Baseline was calculated as the pre-dose measurement at Week 24 minus the Baseline value. The analysis was performed using a mixed model repeated measures (MMRM) method including covariates of treatment group, smoking status (screening), geographical region, visit, baseline, baseline by visit and treatment by visit interactions. ITT Population comprised of all randomized subjects excluding those who were randomized in error. Only participants with analyzable data at the given time point were analyzed.|Baseline to Week 24|ITT Population|||Liters (L)||Standard Error|Least Squares Mean
2585525|NCT02345031|Secondary|Pharmacokinetic of AUT00063, Plasma Levels|Exposure of AUT00063 ng/ml, in plasma levels at Day 28|28 Days||||ng||Standard Deviation|Mean
2585526|NCT02345031|Secondary|To Further Investigate the Safety and Tolerability Profile of Repeat Administration of AUT00063 by Assessing Vital Signs, Physical Examination, Laboratory Exams and ECG|Number of Subjects With At Least One Treatment Emergent Adverse Event|42 Days||||Participants|||Count of Participants
2585527|NCT02345031|Secondary|Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28|Final Average GDT Within-Channel at Day 28: Change from Baseline; FAS Population|28 days|FAS Population|||ms||95% Confidence Interval|Least Squares Mean
2585528|NCT02345031|Secondary|Analysis of Change From Baseline in Adaptive Test of Temporal Resolution (ATTR) on End-Point Visit Day 28|Final Average GDT Across-Channel at Day 28: Change from Baseline; FAS Population|28 days|FAS Population|||ms||95% Confidence Interval|Least Squares Mean
2585529|NCT02345031|Primary|Change in Hearing Loss After 4 Weeks of Treatment|To compare the change in hearing using the QuickSIN test (speech in noise performance) from baseline (Day 1 to Day 28) between AUT00063 and placebo. The QuickSIN test measures the level of signal compared to the noise that is required to achieve 50% recognition. The test is administered in a sound booth at 70-dB HL binaurally via insert-ear phones. Three lists are administered to each individual subject and the threshold or 50% signal-to-noise ratio (SNR) is calculated as the mean of the three lists completed. Each list consists of six sentences with five key words to be scored per sentence. The sentences are presented in four-talker babble noise. The sentences are presented at pre-recorded signal-to-noise ratios which decrease in 5-dB steps from 25 (very easy) to 0 (extremely difficult).|28 days|Full Analysis Set|||decibels (dB)||95% Confidence Interval|Least Squares Mean
2585530|NCT02344745|Secondary|Wong Baker Pain Scale|Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.|15 min after removal of the urodynamics catheters||||units on a scale||Full Range|Median
2585531|NCT02344745|Secondary|Anxiety Measured by VAS|Anxiety was measured using a visual analogue scale, from 0-10 cm. All measurements were rounded to the nearest 0.5 cm. Higher values indicate more anxiety.|15 min after removal of the urodynamics catheters||||cm||Full Range|Median
2585532|NCT02344745|Secondary|Wong Baker Pain Scale|Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.|At the time of catheter placement||||units on a scale||Full Range|Median
2585533|NCT02344745|Primary|Anxiety Measured by VAS|Anxiety was measured using a visual analogue scale, from 0-10 cm. All measurements were rounded to the nearest 0.5 cm. Higher values indicate more anxiety.|At the time of catheter placement||||cm||Full Range|Median
2585534|NCT02344628|Secondary|Number of Participants With Adverse Events|To compare the incidences and relative risk of all Adverse Events (AEs), including treatment-related AEs, Serious Adverse Events (SAEs) and grade 3-4 toxicity in patients treated with AZT20 and AZT30 regimens|6 months||||Participants|||Count of Participants
2585535|NCT02344628|Secondary|Number of Participants With Clinical and Serological Cure in Latent Yaws|Clinical resolution of skin lesion at 4 weeks and at least four-fold decline in Rapid Plasma Reagin titre or seroreversion at 6-month (compared to baseline) in T.pallidum subsp. pertenue Polymerase Chain Reaction-negative.|6 Months||||Participants|||Count of Participants
2585536|NCT02344628|Primary|Number of Participants With Clinical and Serological Cure|Clinical resolution of skin lesion at 4 weeks and at least four-fold decline in Rapid Plasma Reagin titre or seroreversion at 6-month (compared to baseline) in T.pallidum subsp. pertenue Polymerase Chain Reaction-confirmed subjects with yaws.|6 Months||||Participants|||Count of Participants
2585537|NCT02344576|Primary|Effectiveness of Intervention: Values-Choice Concordance|"Effectiveness: Assessed based on if the decision support intervention led to a quality decision (see Knowledge outcome measure for full description). This is part two of the decision quality measure:~-Values: Concordance between patients' and caregivers' stated values and their treatment choice at 1-Month. Values measured on a Likert scale of 1-10, with 1 being Do everything I can to live longer, even if that means having major surgery and being dependent on a machine and 10 being Live with whatever time I have left, without going through major surgery or being dependent on a machine; correlated with patient-reported treatment decision of accepted or declined DT LVAD. Measured by kendall's tau correlation coefficient, which ranges 1 to -1, score closer to 1 or -1 shows greater values-choice concordance (a correlation coefficient of 0 means no concordance). Confidence intervals obtained from the distribution after 500 bootstrap samples (2.5, 97.5 percentiles)."|Baseline 1 (enrollment) and 1 Month Follow-Up|Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in Effectiveness analysis, as this data was collected in surveys.|||kendall's tau correlation coefficient||95% Confidence Interval|Number
2585539|NCT02344576|Secondary|Changes in Family Satisfaction With Patient's Care (Family Satisfaction With Care [Caregivers Only])|"Family Satisfaction with Care (caregivers only): The 10-item Family Satisfaction with Decision-Making around Care of Critically Ill Patients subscale of the Family Satisfaction with Care in the Intensive Care Unit-24. Scoring for each question was on a scale of 0-100, with 0 indicating low satisfaction and 100 indicating high satisfaction; combined total of all 10 questions was taken for final mean score of 0-100 (higher score indicating higher satisfaction)."|1 Month Follow-Up, and 6 Month Follow-Up|"Family Satisfaction with Care was collected for caregiver participants only; does not apply to the Patient arm."|||units on a scale||Standard Error|Mean
2585540|NCT02344576|Secondary|Changes in Illness Acceptance (PEACE Illness Acceptance Measure (Patients Only)|PEACE Illness Acceptance Measure (patients only): 2 part measure: part 1 measures illness acceptances (questions 1-5 of 12-items), scoring 5-20 with higher score indicating greater acceptance of illness; part 2 measures struggle with illness (questions 6-12 of 12-items), scoring 7-28 with higher score indicating greater struggle with illness.|Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up|"PEACE Illness Acceptance Measure was collected for patient participants only; does not apply to the Caregiver arm. Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in PEACE Measure analysis, as this data was collected in surveys."|||units on a scale||Standard Error|Mean
2585541|NCT02344576|Secondary|Changes in Preferences for Control of Medical Decisions (Control Preferences Scale [Patients Only])|"Control Preferences Scale (patients only) includes 2 parts: Preferred and Actual (Actual at 1-Month and 6-Month only). Each is a 1-item question with 5-answer options, assessing preferred or actual control in decision making. Active role indicated if 1 of first 3 answer options were selected: for Preferred, those 3 answer options were I prefer to make the final selection about which treatment I will receive, I prefer to make the final selection of my treatment after seriously considering my doctor's opinion, or I prefer that my doctor and I share responsibility for deciding which treatment is best; for Actual, answer options were I made the final selection about which treatment I would receive, I made the final selection of my treatment after seriously considering my doctor's opinion, or My doctor and I shared responsibility for deciding which was treatment best for me. The percentage of patients who selected an active response option was calculated."|Baseline 1 (enrollment), 1 Month Follow-Up, and 6 Month Follow-Up|"Control Preferences Scale was collected for patient participants only; does not apply to the Caregiver arm. Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in Control Preferences Scale analysis, as this data was collected in surveys."|||percentage of patients in active role|||Number
2585542|NCT02344576|Secondary|Changes in Bereaved Caregiver Satisfaction With End-of-Life Care (Canadian Health Care Evaluation Project - Bereavement Questionnaire [Bereaved Caregivers Only])|Canadian Health Care Evaluation Project - Bereavement Questionnaire (bereaved caregivers only): Score of 0-100 with higher score indicating greater satisfaction.|6 Month Follow-Up|"Bereaved Caregiver Satisfaction was collected for caregiver participants only; does not apply to the Patient arm. This measure was also collected among bereaved caregivers only; 11 bereaved caregivers responded."|||units on a scale||Standard Error|Mean
2585543|NCT02344576|Secondary|Changes in Caregiver's Preparedness for Caregiving (Preparedness for Caregiving Scale [Caregivers Only])|Preparedness for Caregiving Scale (caregivers only): 8-items, scoring 0-4 with higher score indicating more preparedness.|Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up|"Preparedness for Caregiving Scale was collected for caregiver participants only; does not apply to the Patient arm."|||units on a scale||Standard Error|Mean
2585544|NCT02344576|Secondary|Changes in Quality of Life (EuroQol Visual Analogue Scale [Patients Only])|"EuroQol Visual Analogue Scale (patients only): 1-item scale, score of 0-100 with 0 being worst imaginable health state and 100 being best imaginable health state."|Baseline 1 (enrollment), 1 month Follow-Up, and 6 month Follow-Up|"EuroQol Visual Analogue Scale was collected for patient participants only; does not apply to the Caregiver arm. Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in EuroQol Visual Analogue Scale analysis, as this data was collected in surveys."|||units on a scale||Standard Error|Mean
2585545|NCT02344576|Secondary|Changes in Stress and Depression (Perceived Stress Scale; Patient Health Questionnaire-2)|Perceived Stress Scale (collected at Baseline 1 and 6-month follow-up only):10-items, scoring 0-40 with higher score indicating greater stress.; Patient Health Questionnaire-2: 2-items, score of 0-6 with higher score indicating greater depression.|Baseline 1 (enrollment), 1 month Follow-Up, and 6 Month Follow-Up|Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in Stress and Depression analysis, as this data was collected in surveys.|||units on a scale||Standard Error|Mean
2585546|NCT02344576|Secondary|Changes in Decision Regret (Decision Regret Scale)|Decision Regret Scale: 5-items, scoring 0-100 with higher score indicating greater decision regret.|1 Month Follow-Up, and 6 Month Follow-Up|Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in Decision Regret analysis, as this data was collected in surveys.|||units on a scale||Standard Error|Mean
2585547|NCT02344576|Secondary|Changes in Decision Conflict (Decision Conflict Scale)|Decision Conflict Scale: 16-items, scoring 0-100 with higher score indicating greater decisional conflict.|Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment), 1 Month Follow-Up, and 6 Month Follow-Up|Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in Decision Conflict analysis, as this data was collected in surveys.|||units on a scale||Standard Error|Mean
2585548|NCT02344576|Primary|Maintenance of Intervention|Maintenance: Assessing whether sites decide at the conclusion of the study to maintain, modify, or discontinue a program. We will assess maintenance by counting the number of sites who continue the intervention after the study enrollment period has ended.|6 months after study enrollment end date|"Maintenance is measured by sites only; does not apply to the Patient and Caregiver arms. Maintenance pertains to only the intervention phase; thus, for overall number of participants analyzed, includes patients and caregivers in intervention phase only."|||Sites|Sites||Count of Units
2585650|NCT02342743|Primary|Change From Baseline in Acute Medication Intake|Overall acute headache pain medication use (all categories) mean change between the 28-day baseline and the 28-day period ending with week 12 of treatment.|End of baseline period and end of 12 weeks treatment period||||medications per 28-days||Standard Deviation|Mean
2585549|NCT02344576|Primary|Implementation of Intervention|Implementation: The extent to which the intervention is implemented as intended. We will assess implementation by surveying the consistency of decision aid delivery by the sites to the enrolled patients.|Baseline 2 (post-education: average 3 days after enrollment)|"Implementation was collected for patient participants only; does not apply to the Caregiver arm. Implementation pertains to only patients in the intervention phase; control arms are not included here.Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included."|||percentage of eligible participants|||Number
2585550|NCT02344576|Primary|Adoption of Intervention|Adoption: The absolute number of settings who are willing to initiate a program. We will assess the number of sites who agreed to be part of the study and who initiate intervention at intervention period.|At time of intervention phase start|"Adoption is measured by sites only; does not apply to the Patient and Caregiver arms. Adoption pertains to only the intervention phase; thus, for overall number of participants analyzed, includes patients and caregivers in intervention phase only."|||Sites|Sites||Count of Units
2585551|NCT02344576|Primary|Effectiveness of Intervention: Knowledge|"Effectiveness: Assessed based on if the decision support intervention led to a quality decision. Decision quality is defined as the extent to which the implemented decision reflects the considered preferences of a well-informed patient. By this definition, a decision is a quality decision if the treatment chosen is concordant with a knowledgeable patient's values. Decision quality measures consist of 2 domains: knowledge and values.~This is part one of the decision quality measure:~-Knowledge: DT LVAD knowledge score improvement from Baseline 1 (enrollment) to Baseline 2 (post-education), measured by percentage of score improvement (scale of 0-100%)."|Baseline 1 (enrollment), Baseline 2 (post-education: average 3 days after enrollment)|Those patients who agreed to medical record review only (n=7 control, n=8 intervention) were not included in Effectiveness analysis, as this data was collected in surveys.|||percentage of score improvement||Standard Error|Mean
2585552|NCT02344576|Primary|Reach of Intervention|Reach: The proportion of the target population who participate in the intervention. We will assess the percentage of patients and caregivers that receive the pamphlet and video decision aids.|Baseline 2 (post-education: average 3 days after enrollment)|Reach pertains to only those participants in the intervention phase, and therefore the control arms are not included here.|||Participants|||Count of Participants
2585553|NCT02344407|Primary|Immunogenicity Measures (ELISA and Neutralization Antigen-specific Assays for Antibody.|Antibody Response at 1-Month (EU/mL) for Participants Without Elevated Levels at Entry|One month|Participants with 1-month antibody data without elevated antibody levels at entry|||EU/mL||95% Confidence Interval|Geometric Mean
2585554|NCT02344407|Primary|Serious Adverse Events.|Number of Participants Experiencing Serious Adverse Events in First 30 Days|One month|All Participants Randomized|||Participants|||Count of Participants
2585555|NCT02344342|Secondary|Days to Hospitalization or Death (if it Occurs Within 180 Days)|Time to Hospitalization (if participant was hospitalized and did not die) or death whichever came first. In fact all participants who died in the follow up period were hospitalized first, so actual data reported below also represents time to hospitalization for all participants.|180 days|All participants who completed 180 days or died prior to 180 days (all who completed study and all listed in all cause mortality)|||days till hospitalization||95% Confidence Interval|Mean
2585556|NCT02344342|Secondary|Minnesota Living With Heart Failure Questionnaire|It provides a total score (range 0-105, where 0 is best quality of life up to 105 as worst Health Related Quality of Life),|180 day follow up|2 patients completed the study, whose answers were not coded into the analysis for the questionnaire, therefore they are not included in the report for this secondary end point. The subjects included completed the 180 follow up period. Subjects that had less than 180 days of follow up at the time of study closure are excluded from this analysis.|||units on a scale||Full Range|Mean
2585557|NCT02344342|Secondary|Self Care for Heart Failure Index Score|The self care for heart failure index score ranges from 22 to 88 where 22 is the lowest score meaning cares for oneself least well and 88 means one is most confident or able to care for oneself properly.|180 day follow up|Two participants completed the study but did not answer all of the questions on this questionnaire, and therefore they are not included in the report for this secondary end point. The subjects included completed the 180 follow up period. Subjects that had less than 180 days of follow up at the time of study closure are excluded from this analysis.|||units on a scale||Full Range|Mean
2585558|NCT02344342|Primary|Number of Days Hospitalized or Dead in the 180 Day Follow up Period|This is the total combined number of days that all participants in each arm were hospitalized or dead between day 1 and day 180. It is a method to combine the endpoints of death and hospitalization used in heart failure trials. Days hospitalized for all participants are added to days dead for all participants, per arm.|180 days (6 months)|The subjects included in this measure each completed the 180 follow up period or died within the 180 follow up period. Subjects that had less than 180 days of follow up at the time of study closure are excluded from this analysis.|||Days|||Number
2585559|NCT02344251|Secondary|Safety Assessment: Rates of Adverse Events Reported|A secondary outcome will be safety assessment as measured by the percentage of participants reporting adverse events.|30 days||||percentage of participants reporting AEs|||Number
2585560|NCT02344251|Primary|Medication Adherence|The primary outcome will be medication adherence as measured by percentage of doses taken among groups.|30 days||||percentage of doses taken||95% Confidence Interval|Number
2585561|NCT02344238|Secondary|Number of Participants Reporting Adverse Events|A secondary outcome will be safety and tolerability of ingestion of the ID Cap as measured by number of participants reporting adverse events in Group 1 who received standard capsules (no ID technology, study Arm 1) and Group 2 who received ID-Capsules (study Arms 2 and 3).|30 days||||Participants|||Count of Participants
2585562|NCT02344238|Primary|Medication Adherence|The primary outcome will be medication adherence as measured by percentage of doses taken among groups.|30 days||||percentage of doses taken (pill count)||95% Confidence Interval|Number
2585651|NCT02342743|Primary|Change From Baseline in Frequency of Headache Days|Mean change in frequency of headache days (defined as a day with at least one headache episode, which is a patient-reported headache with pain) between the 28-day baseline and the 28-day period ending with week 12 of treatment.|End of baseline period and end of 12 weeks treatment period||||days per 28-days||Standard Deviation|Mean
2585563|NCT02344173|Primary|Number of Subjects That Experienced 1 or More Procedure and/or Device-related Cardiovascular SAE/SADEs.|"Procedure and/or Device-Related Cardiovascular SAE/SADEs. This registry collected information about adverse events deemed of cardiovascular origin (Cardiovascular Serious Adverse Event) with the potential of leading to:~Death~A serious deterioration in the health of the subject~Fetal distress, fetal death or a congenital abnormality or birth defect~A planned hospitalization for a pre-existing condition was not considered a serious adverse event. Reporting of non-serious events and non-cardiovascular events was not required."|12 months post procedure|Enrolled subjects|||Participants|||Count of Participants
2585564|NCT02344173|Primary|Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a 3-month Blanking Period.|Freedom from AF/AFL/AT (atrial fibrillation/atrial flutter/atrial tachycardia) with or without the use of anti-arrhythmic drugs after a 3-month blanking period. Repeat ablations during the 3-month blanking period do not count as effectiveness failures. A repeat ablation procedure after the 3-month blanking period is counted as an effectiveness failure.|12 months post procedure|Treated Subjects|||Participants|||Count of Participants
2585565|NCT02344173|Primary|Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a 3-month Blanking Period.|Freedom from AF/AFL/AT (atrial fibrillation/atrial flutter/atrial tachycardia) with or without the use of anti-arrhythmic drugs after a 3-month blanking period. Repeat ablations during the 3-month blanking period do not count as effectiveness failures. A repeat ablation procedure after the 3-month blanking period is counted as an effectiveness failure.|12 months post procedure|Subjects that completed 12-month visit|||Participants|||Count of Participants
2585566|NCT02344004|Secondary|Change From Baseline (Day 1) at Month 6 in the St. George's Respiratory Questionnaire (SGRQ) Total Score|The SGRQ was completed before administration of study drug at Baseline (Day 1) and Months 3, 6, 8, and 12, and at the EOT visit and the 3 months off treatment visit. The SGRQ is a self-administered questionnaire that has been validated in participants with airways disease, specifically in participants with bronchiectasis. The SGRQ assesses health-related quality of life in participants with chronic pulmonary disease by evaluating 3 health domains: symptoms (distress caused by respiratory symptoms); activity (effects of disturbances on mobility and physical activity); and impacts (the effect of disease on factors such as employment, personal control of one's health, and need for medication). A composite total score is derived as the sum of domain scores for symptoms, activity, and impact (0=the best possible score and 100=the worst possible score). A reduction in score of 4 units is generally recognized as a clinically meaningful improvement in quality of life.|by Month 6|The ITT population was the set of all randomized participants. Participants were classified according to their assigned treatment. There was a total of 336 participants in the ITT population, including 224 participants in the LAI + MDR arm and 112 participants in the MDR alone arm.|||score on a scale||Standard Deviation|Mean
2585567|NCT02344004|Secondary|Change in 6-Minute Walk Test (6MWT) Distance at EOT in the LAI Arm Compared to a Multi-drug Regimen Alone|A 6-minute walk assessment of exertional capability was performed at Baseline (Day 1) and up to EOT or Month 16. The standardized protocol based on the ATS guidelines was used. The 6MWT was conducted by a site member who was blinded to the participant's open-label treatment assignment.|up to Month 16|Due to the widely varying timepoints that makeup the EOT visit, this was not considered an appropriate analysis and was not performed.||||||
2585568|NCT02344004|Secondary|Number of Participants Achieving Sustained Culture Conversion at the End of Treatment (EOT) in the LAI + MDR Arm Compared to the MDR Arm Alone|Sustained conversion was evaluated in participants who completed at least 12 months of treatment from the start of culture conversion. Sustained conversion was defined as conversion (3 consecutive negative monthly sputum samples) by Month 6 with no positive agar media culture or no more than 2 broth media cultures up to and including the time point. Participants who did not convert were considered non-sustained conversions.|up to Month 16|The ITT population was the set of all randomized participants. Participants were classified according to their assigned treatment. There was a total of 336 participants in the ITT population, including 224 participants in the LAI + MDR arm and 112 participants in the MDR alone arm.|||Participants|||Count of Participants
2585569|NCT02344004|Secondary|Time to Culture Conversion at Month 6 in the LAI + MDR Arm Compared to the MDR Alone Arm|"The time to culture conversion was defined by the date of the first of at least 3 consecutive monthly culture specimens that were Mycobacterium avium complex (MAC)-negative.~The 25th percentile time to conversion is the estimated time taken for 25% of participants to convert.~The 50th percentile time to conversion is the estimated time taken for 50% of participants to convert."|at Month 6|There was a total of 336 participants in the ITT population, including 224 participants in the LAI + MDR arm and 112 participants in the MDR alone arm.|||months||95% Confidence Interval|Number
2585570|NCT02344004|Secondary|Change From Baseline (Day 1) to Month 6 in the Six-Minute Walk Test (6MWT) Distance in the LAI + MDR Arm Compared to the MDR Alone Arm|A 6-minute walk assessment of exertional capability was performed at Baseline (Day 1) and at Month 6. The standardized protocol based on the ATS guidelines was used. The 6MWT was conducted by a site member who was blinded to the participant's open-label treatment assignment. The analysis of the change from Baseline (Day 1) to Month 6 in the 6MWT distance was performed after the last participant completed Month 6 and his/her 6MWT distance data were available.|at Month 6|The ITT population was the set of all randomized participants. Participants were classified according to their assigned treatment. There was a total of 336 participants in the ITT population, including 224 participants in the LAI + MDR arm and 112 participants in the MDR alone arm.|||meters||Standard Deviation|Mean
2585593|NCT02343458|Secondary|Change From Baseline in SGRQ Total Score at Week 24 in Symptomatic Population, US/China Approach|Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life|at week 24|Symptomatic Population was defined as all subjects in the ITT Population with CAT scores of ≥15 at Visit 2n|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2585571|NCT02344004|Primary|Number of Participants Achieving Durable Culture Conversion Through 3 Months Off Treatment in the LAI + MDR Arm Compared to the MDR Arm Alone|"Sputum specimens were collected at screening, baseline (Day 1), during treatment, and at Months 1, 3, 6, and 12 months off treatment. Culture conversion with durability was defined as achieving culture conversion by Month 6 and then having no more than 2 consecutive broth positive cultures and no Agar positive culture up to 3 months off treatment. Converters with missing broth or Agar sputum culture result after Month 6 up to 3 months off treatment were considered as not achieving culture conversion with durability except those participants who are unable to produce sputum despite reasonable efforts, as reported by source documentation. Participants who had relapse/recurrence, had rescue medication and/or died before reaching 3 months off treatment were considered as not achieving culture conversion with durability."|up to Month 28|The ITT population was the set of all randomized participants. Participants were classified according to their assigned treatment. There was a total of 336 participants in the ITT population, including 224 participants in the LAI + MDR arm and 112 participants in the MDR alone arm.|||Participants|||Count of Participants
2585572|NCT02344004|Primary|Number of Participants Achieving Culture Conversion by Month 6 in the Liposomal Amikacin for Inhalation (LAI) + Multi-drug Regimen (MDR) Arm Compared to the MDR Alone Arm|Sputum specimens were collected at Screening (Visit 1), Baseline (Visit 2), and at Visits 3 (Month 1) through 8 (Month 6). A negative culture result reflected a negative culture result for all sputum samples collected at each visit. Participants met the primary endpoint of culture conversion by Month 6 if they had 3 consecutive monthly MAC-negative sputum cultures during the first 6 months of the study. A participant needed to achieve the first of 3 consecutive negative sputum cultures (that defined culture conversion) by Month 4 in order to meet the primary endpoint by Month 6. Each participant in the intent to treat (ITT) population (ie, all randomized participants) was classified as either a converter or non-converter by Month 6.|by Month 6|The ITT population was the set of all randomized participants. Participants were classified according to their assigned treatment. There was a total of 336 participants in the ITT population, including 224 participants in the LAI + MDR arm and 112 participants in the MDR alone arm.|||Participants|||Count of Participants
2585573|NCT02343939|Secondary|Percentage of Participants Who Experienced Laboratory Abnormalities|Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.|First dose date up to the last dose date plus 30 days (maximum: 18 months)|Participants in the Safety Analysis Set who had non-missing postbaseline value prior to or on the last dosing date plus 30 days were analyzed.|||percentage of participants|||Number
2585574|NCT02343939|Secondary|Percentage of Participants Experiencing Treatment-Emergent Adverse Events||First dose date up to the last dose date plus 30 days (maximum: 18 months)|Participants in the Safety Analysis Set were analyzed.|||percentage of participants|||Number
2585575|NCT02343939|Secondary|Overall Survival (OS)|OS was defined as the time interval from the start of the study therapy to death from any cause. Median OS was analyzed using KM method.|First dose date up to approximately 38 months|Participants in the Full Analysis Set were analyzed.|||months||95% Confidence Interval|Median
2585576|NCT02343939|Secondary|Event Free Survival (EFS)|EFS was defined as the time interval from the start of the study therapy until the date of treatment failure, acute myeloid leukemia (AML) relapse, or death from any cause, whichever occurred first. Participants who received other anti-cancer therapy (prior to the event if any) were censored. Median EFS was analyzed using Kaplan-Meier (KM) method.|First dose date up to approximately 38 months|Participants in the Full Analysis Set were analyzed.|||months||95% Confidence Interval|Median
2585577|NCT02343939|Secondary|Duration of Exposure of Entospletinib||First dose date up to approximately 3 years|The Safety Analysis Set included all participants who received at least 1 dose of study drug.|||weeks||Full Range|Median
2585578|NCT02343939|Primary|Percentage of Participants With Overall Response at the End of Induction|Clinical response was assessed according to the International Working Group criteria (Cheson 2003). Overall response included CR, CRc, CRi, and partial remission (PR). CR required all of the following: < 5% blasts in bone marrow aspirate; Neutrophils ≥ 1,000/mcL; Platelets ≥ 100,000/mcL; No extramedullary disease; No blasts with Auer rods detected; and Independent of transfusions. CRc, in addition to CR criteria, required reversion to a normal karyotype with an abnormal karyotype at the time of diagnosis. CRi required all of the CR criteria except the criterion of neutrophils and platelets. PR required all of the following: ≥ 50% decrease in blasts in bone marrow aspirate to a range of 5% to 25%; Neutrophils ≥ 1,000/mcL; Platelets ≥ 100,000/mcL; Independent of transfusions; and A value of ≤ 5% blasts was also considered a PR if Auer rods were detected.|At the end of induction (Group A: up to end of Cycle 2; Group B: up to end of Cycle 4) (cycle length = up to 28 days); Group C: From Day 1 until meeting the criteria for study treatment discontinuation (up to approximately 3 years)|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2585579|NCT02343939|Primary|Percentage of Participants With Composite Complete Remission at the End of Induction|Clinical response was assessed according to the International Working Group criteria (Cheson 2003). Composite complete remission included CR, CRc, and morphologic complete remission with incomplete blood count recovery (CRi). CR required all of the following: < 5% blasts in bone marrow aspirate; Neutrophils ≥ 1,000/mcL; Platelets ≥ 100,000/mcL; No extramedullary disease; No blasts with Auer rods detected; and Independent of transfusions. CRc, in addition to CR criteria, required reversion to a normal karyotype with an abnormal karyotype at the time of diagnosis. CRi required all of the CR criteria except the criterion of neutrophils and platelets.|At the end of induction (Group A: up to end of Cycle 2; Group B: up to end of Cycle 4) (cycle length = up to 28 days); Group C: From Day 1 until meeting the criteria for study treatment discontinuation (up to approximately 3 years)|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2585603|NCT02343458|Primary|Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks. Primary Endpoint, EU/SK/TW Approach, Secondary Endpoint US/China Approach.|Change from baseline in morning pre-dose trough FEV1 over 24 weeks. Primary endpoint, EU/SK/TW approach, Secondary endpoint US/China approach.|over 24 weeks|ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data|||mL||95% Confidence Interval|Least Squares Mean
2585580|NCT02343939|Primary|Percentage of Participants With Morphologic Complete Remission (CR) at the End of Induction|Clinical response was assessed according to the International Working Group criteria (Cheson 2003). Morphologic CR included CR and cytogenetic CR (CRc). CR required all of the following: < 5% blasts in bone marrow aspirate; Neutrophils ≥ 1,000/microliter (mcL); Platelets ≥ 100,000/mcL; No extramedullary disease; No blasts with Auer rods detected; and Independent of transfusions. CRc, in addition to CR criteria, required reversion to a normal karyotype with an abnormal karyotype at the time of diagnosis.|At the end of induction (Group A: up to end of Cycle 2; Group B: up to end of Cycle 4) (cycle length = up to 28 days); Group C: From Day 1 until meeting the criteria for study treatment discontinuation (up to approximately 3 years)|The Full Analysis Set included all participants who received at least 1 dose of study drug with treatment designated according to the planned treatment.|||percentage of participants||95% Confidence Interval|Number
2585581|NCT02343939|Primary|Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)|DLTs refer to toxicities experienced during the first 28 days of study treatment that have been judged to be clinically significant and related to study treatment. DLT assessment was applicable only for Phase 1b and Phase 2 safety run-in participants.|Group A: Cycle 0 Day 1 to Cycle 2 Day 28; Group B: Cycle 0 Day 1 to Cycle 1 Day 28; Group C: Cycle 1 Day 1 to Cycle 1 Day 28 (Cycle length: for Cycle 0 = 14 days, for all other cycles = 28 days)|The DLT Analysis Set included all participants who received 21 days of ENTO (applicable to all groups) and all doses of cytarabine and daunorubicin in Group A Phase 1b, decitabine in Group B Phase 1b, or azacitidine in Group B Phase 2 safety run-in during the DLT assessment window; or experienced a DLT during the DLT assessment window.|||percentage of participants|||Number
2585582|NCT02343627|Primary|Number of Participants With Negative Fungal Culture|To assess number of participants with negative fungal culture after repeated once-daily topical applications for 28 days|28 days|Subjects with fungal culture collected at the study day 28 visit. The subjects may not complete all study visits.|||Participants|||Count of Participants
2585583|NCT02343575|Secondary|Length of Hospital Stay|Participation in the study ended once delirium was resolved and the patient was off study drug. This outcome presents the total length of hospital stay, which may have been longer than participation in the study.|During expected average hospitalization (of 1 month)||||days||Standard Deviation|Mean
2585584|NCT02343575|Secondary|Length of ICU Stay||During expected average hospitalization (of 1 month)|Data were not collected for this outcome||||||
2585585|NCT02343575|Secondary|Intensity of Delirium as Measured by the Intensive Care Delirium Screening Checklist (ICDSC) Delirium Severity Scale|The items include the assessment of: (1) consciousness ( deep sedation/coma, agitation, normal wakefulness, or light sedation); (2) inattention; (3) disorientation; (4) hallucination, delusion, or psychosis; (5) psychomotor agitation or retardation; (6) inappropriate speech or mood; (7) sleep-wake cycle disturbances; and (8) fluctuation of symptomatology. The maximum score is eight; scores of ≥4 indicate the presence of delirium and score zero is indicate not in delirium. Each item is scored 0-8.|Up to 5 days||||score on a scale||Standard Deviation|Mean
2585586|NCT02343575|Secondary|Side Effects From Medications|Side effects may have included liver function test (LFT) increase, platelet decrease, bleeding, or QTc prolongation.|Up to 5 days||||Participants|||Count of Participants
2585587|NCT02343575|Secondary|Use of as Needed Anti-psychotic Agent|Amount of Haldol administered.|Up to 5 days||||mg||Standard Deviation|Mean
2585588|NCT02343575|Primary|Time to Delirium Resolution|Delirium resolution was defined as three negative Confusion Assessment Method (CAM) assessments, performed by nurses every 12 hours.|Up to 5 days||||days||Standard Deviation|Mean
2585589|NCT02343458|Secondary|FEV1 Measured at 15 Minutes Post-dose on Day 1|Onset of Action as Assessed by FEV1 Day 1 at 15 Minutes Post-Dose. Reported is the FEV1 measured at 15 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant|Assessed at 15-minute post dose on Day 1|ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data|||Liters||95% Confidence Interval|Least Squares Mean
2585590|NCT02343458|Secondary|FEV1 Measured at 5 Minutes Post-dose on Day 1|Onset of Action as Assessed by FEV1 Day 1 at 5 Minutes Post-Dose. Reported is the FEV1 measured at 5 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant|Assessed at 5-minutes post dose on Day 1|ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data|||Liters||95% Confidence Interval|Least Squares Mean
2585591|NCT02343458|Secondary|Change From Baseline in Average Daily Rescue Ventolin Use Over 24 Weeks in RVU Population, All Approaches|Change from baseline in average daily rescue Ventolin use over 24 weeks in RVU population, all approaches|over 24 weeks|RVU Population - defined as Rescue Ventolin User|||Puffs/day||95% Confidence Interval|Least Squares Mean
2585592|NCT02343458|Secondary|Change From Baseline in SGRQ Total Score Over Weeks 12-24, in Symptomatic Population, Japan & EU/SK/TW Approach|Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life|over weeks 12-24|Symptomatic Population was defined as all subjects in the ITT Population with CAT scores of ≥15 at Visit 2|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2585604|NCT02343458|Primary|Change From Baseline in Morning Pre-dose Trough FEV1 Over Weeks 12-24, Japan Approach|Change from baseline in morning pre-dose trough FEV1 over weeks 12-24, Japan approach|over weeks 12-24|ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data|||mL||95% Confidence Interval|Least Squares Mean
2585594|NCT02343458|Secondary|Change From Baseline in SGRQ Total Score Over Weeks 12-24 , Japan & EU/SK/TW Approach|Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life|over weeks 12-24|ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2585595|NCT02343458|Secondary|Change From Baseline in SGRQ Total Score at Week 24, US/China Approach|Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life|at week 24|ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2585596|NCT02343458|Secondary|Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks EU/SK/TW Approach|Peak change from baseline in FEV1 within 2 hours post-dosing over 24 weeks EU/SK/TW approach|over 24 weeks|ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data|||mL||95% Confidence Interval|Least Squares Mean
2585597|NCT02343458|Secondary|Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over Weeks 12-24 Japan Approach|Peak change from baseline in FEV1 within 2 hours post-dosing over weeks 12-24 Japan approach|over weeks 12-24|ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data|||mL||95% Confidence Interval|Least Squares Mean
2585598|NCT02343458|Secondary|Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing at Week 24 US/China Approach|Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24 US/China approach|at week 24|ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data|||mL||95% Confidence Interval|Least Squares Mean
2585599|NCT02343458|Secondary|TDI Focal Score Over Weeks 12-24 - Japan Approach - Symptomatic Population|TDI focal score over 12-24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9|over weeks 12-24|Symptomatic Population was defined as all subjects in the ITT Population with CAT scores of ≥15 at Visit 2|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2585600|NCT02343458|Secondary|TDI Focal Score Over 24 Weeks - US/China and EU/SK/TW Approaches -Symptomatic Population|TDI focal score over 24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9|over 24 Weeks|Symptomatic Population was defined as all subjects in the ITT Population with CAT scores of ≥15 at Visit 2|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2585601|NCT02343458|Secondary|TDI Focal Score Over Weeks 12-24 Japan Approach|TDI focal score over 12-24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9|over Weeks 12-24|ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2585602|NCT02343458|Secondary|TDI Focal Score Over 24 Weeks, US/China and EU/SK/TW Approach|TDI focal score over 24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9|over 24 Weeks|ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2585644|NCT02342743|Secondary|Change in the Average Headache Intensity|Mean change in the average headache intensity between the 28-day baseline and the 28-day period ending with week 12 of treatment. Headache intensity is defined on a scale from 0 (no pain) to 3 (maximum pain).|End of baseline period and end of 12 weeks treatment period||||units on a scale||Standard Deviation|Mean
2585605|NCT02343458|Primary|Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 of Treatment (US/China Approach)|For the US/China approach, the primary endpoint was the change from baseline in morning pre-dose trough FEV1 at Week 24 of treatment|at week 24|ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data|||mL||95% Confidence Interval|Least Squares Mean
2585606|NCT02343380|Secondary|Intra-individual Variations in the Values of Glucagon-like Peptide-1 After the Morning and Evening Meal Consumption||Every 30-min from the beginning of the meal for 180-min|These variables were not measured, since data were not collected.||||||
2585607|NCT02343380|Secondary|Intra-individual Variations in the Values of Acylated Ghrelin After the Morning and Evening Meal Consumption||Every 30-min from the beginning of the meal for 180-min||||ng/l x h||95% Confidence Interval|Mean
2585608|NCT02343380|Secondary|Intra-individual Variations in the Values of Adrenalin and Noradrenalin, After the Morning and Evening Meal Consumption||Every 30-min from the beginning of the meal for 180-min||||ng/l x h||95% Confidence Interval|Mean
2585609|NCT02343380|Secondary|Variation in Morning Triglyceride and Free Fatty Acid (FFA) Area-Under the Curve (AUC)s After the Consumption of a Meal at 8:00 am Compared With Evening Glucose and Insulin AUCs After the Consumption of the Same Meal at 8:00 pm|"Triglycerides and FFA values measured every 30 minutes after meal for 180-min. Time 0 was before the meal. Times 30, 60, 90, 120, 150 and 180 were referred to the time intervals in minutes from the beginning of the meal. AUCs were calculated according to the trapezoidal model.~FFA concentrations were measured by a fluorometric assay. Plasma triglycerides were assayed by enzymatic colorimetric method.~Serum glucose was measured by enzymatic colorimetric assay; serum insulin was determined by immunoradiometric assay."|From the beginning of the meal for 180-min||||mmol/l*h||95% Confidence Interval|Mean
2585610|NCT02343380|Secondary|Variation in Morning Glucose and Insulin Area-Under the Curve (AUC)s After the Consumption of a Meal at 8:00 am Compared With Evening Glucose and Insulin AUCs After the Consumption of the Same Meal at 8:00 pm|"Glucose and insulin values measured every 30 minutes after meal for 180-min. Time 0 was before the meal. Times 30, 60, 90, 120, 150 and 180 were referred to the time intervals in minutes from the beginning of the meal. AUCs were calculated according to the trapezoidal model.~Serum glucose was measured by enzymatic colorimetric assay; serum insulin was determined by immunoradiometric assay."|From the beginning of the meal for 180-min||||ug/ml*h||95% Confidence Interval|Mean
2585611|NCT02343380|Primary|Intra-individual Variation in Morning Diet-induced Thermogenesis (DIT) Evaluated by Calorimetric Exam After the Consumption of a Meal at 8:00 am Compared With Evening DIT Evaluated by Calorimetric Exam After the Consumption of the Same Meal at 8:00 pm|Indirect calorimetry by Deltatrac II (DATEX, Division of Instruments Corp. Helsinki, Finland) is used to measure the rate of energy expenditure before- and after- the meal.Diet-induced thermogenesis is considered as the difference between average after-meal and basal energy expenditure.|Before and 180-min from the beginning of the meal||||kcal/min||95% Confidence Interval|Mean
2585612|NCT02343276|Secondary|Radiation Exposure|Total radiation required to complete the procedure.|Immediate||||mGy||Standard Deviation|Mean
2585613|NCT02343276|Secondary|Procedure Duration|Procedure duration, from artery catheterization up to removal of sheath.|Immediate||||minutes||Standard Deviation|Mean
2585614|NCT02343276|Primary|Pain Assessment Using Visual Analogue Scale|the patients' feeling of pain in the forearm, and it was measured using a visual analogue scale (VAS), applied at the end of the procedure by an interventional nurse. The VAS consists of a single line measuring 100 mm, anchored by verbal descriptors, saying 'no pain' and 'worst possible pain'. Higher values mean a worse pain.|Five minutes after sheath removal||||score on a scale||Standard Deviation|Mean
2585615|NCT02343263|Secondary|Time to Return to Normal Activity|The postoperative pain assessment sheets will contain a daily entry for the estimated number of postoperative days until patient returned to normal activity level.|10 days|data not collected||||||
2585616|NCT02343263|Secondary|Postoperative Nausea & Emesis|The postoperative pain assessment sheets will contain a daily entry for the estimated number of episodes of vomiting the patient experienced.|10 days|data not collected||||||
2585617|NCT02343263|Secondary|Number of Required Calls to Healthcare Personnel (Either the Clinic or the Physician on Call Overnight)|The postoperative pain assessment sheets will contain a daily entry for the estimated number of required calls to the clinic or to the physician on call overnight.|10 days|data not collected||||||
2585618|NCT02343263|Secondary|Time to Return to Normal Diet|The postoperative pain assessment sheets will contain a daily entry for the estimated number of postoperative days until patient returned to normal diet.|10 days|data not collected||||||
2585619|NCT02343263|Secondary|Total Pain Medication Usage|The postoperative pain assessment sheets will contain a daily entry for the estimated total doses of pain medication required and will distinguish between the need for narcotic and non-narcotic pain medication requirements.|10 days|data not collected||||||
2585620|NCT02343263|Primary|Postoperative Pain; Study Terminated Due to FDA Requirement for a Investigational New Drug Application Requirement|Parents/caregivers will be asked to perform thrice daily pain assessments utilizing a validated postoperative pain measurement scale for the 10 days after surgery. study terminated due to FDA requirement for a investigational new drug application requirement|10 days|data not collected||||||
2585621|NCT02343263|Primary|Postoperative Hemorrhage; Study Terminated Due to FDA Requirement for a Investigational New Drug Application Requirement|Tonsillectomy (and adenotonsillectomy) are associated with a 3-5% postoperative hemorrhage risk from the tonsillectomy wound beds across the United States; our institution has a calculated average of between 4% - 5%. Parents will be contacted 2 to 3 weeks following their procedure and inquiries about post-operative bleeding will be made. Bleeding >1 tablespoon or that requires A) presentation to an emergency department, B) admission to a hospital, or C) return to the operating room will be considered significant post-operative hemorrhage. Distinction will also be made between early (<24 hours after surgery) and late (>24 hours after surgery) postoperative bleeding. The bleeding risk after 2 weeks from surgery is exceedingly small. No prior studies have identified any increased risk with utilizing either fibrin sealant or bupivacaine. This study will evaluate whether the intervention reduces bleeding risk.|14 days|Data not collected||||||
2585622|NCT02343159|Secondary|Work Productivity and Activity Impairment Questionnaire (WPAI: MS Version 2.0)|The WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|Month 6, Month 12|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2585623|NCT02343159|Secondary|Multiple Sclerosis Impact Scale (MSIS-29)|The 29-item MSIS-29 is a participant-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a participants perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.|Month 6, Month 12|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2585624|NCT02343159|Secondary|Compliance Rates at Month 6 and 12|Compliance rates defined as the proportion of actual DMF doses taken per label according to feedback from MEMS data over total expected DMF doses per label during treatment period.|Month 6, Month 12|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2585625|NCT02343159|Secondary|Persistence Rates at Months 6 and 12|Persistence rates defined as the proportion of time on treatment over the study observation time period.|Month 6, Month 12|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2585626|NCT02343159|Secondary|Overall Adherence Rates at Month 6: Arm 2 vs. Arm 1|Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.|Month 6|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2585627|NCT02343159|Secondary|Overall Adherence Rates at Month 6: Arm 3 vs. Arm 1|Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.|Month 6|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2585628|NCT02343159|Secondary|Overall Adherence Rates at Month 12: Arm 2 vs. Arm 1|Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.|Month 12|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2585629|NCT02343159|Primary|Overall Adherence Rates at Month 12: Arm 3 vs. Arm 1|Adherence is defined as the proportion of time on treatment over the study observation time period, times the proportion of actual DMF doses taken per label according to feedback from MEMS data over the total expected DMF doses per label during a treatment period.|Month 12|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2585630|NCT02343081|Primary|AUC0-∞|Extent of absorption of Temozolomide from time (0) to infinity (∞) will be measured after oral administration of the test product (Dralitem®, Monte Verde S.A.) or the reference product (Temodal®, Schering-Plough).|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4|All those subjects who completed the study and were compliant with all the protocol procedures were considered evaluable for statistical pharmacokinetic analysis. Those who received at least one dose of the products under study but did not comply with the study procedures were included in the safety analysis only.|||mcg*h/mL||Standard Deviation|Mean
2585631|NCT02343081|Primary|AUC0-t|Extent of absorption of Temozolomide from time (0) to the last quantifiable concentration (t) will be measured after the oral administration of the test product (Dralitem®, Monte Verde S.A.) or the reference product (Temodal®, Schering-Plough)|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4|All those subjects who completed the study and were compliant with all the protocol procedures were considered evaluable for statistical pharmacokinetic analysis. Those who received at least one dose of the products under study but did not comply with the study procedures were included in the safety analysis only.|||mcg*h/mL||Standard Deviation|Mean
2585632|NCT02343081|Other Pre-specified|T1/2|Time required for Temozolomide plasma concentration to decrease by 50%|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4||||hours||Standard Deviation|Mean
2585633|NCT02343081|Other Pre-specified|Kel|Rate at which Temozolomide is removed from the body.|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4||||1/h||Standard Deviation|Mean
2585634|NCT02343081|Secondary|Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs and SAEs will be collected from the start of study treatment and until two weeks post last dose. If AEs or SAEs extend in time and are not resolved before the end of the 2-week follow up period, this period shall last until the event/s are resolved.|Up to two weeks post last dose|||||||
2585645|NCT02342743|Secondary|50% Responder Rate for Migraine Days|Number of subjects who observe a 50% reduction in the frequency of their migraine days between the 28-day baseline and the 28-day period ending with week 12 of treatment.|End of the 12 weeks treatment period||||Participants|||Count of Participants
2585716|NCT02342171|Secondary|Number of Transfusion-related Serious Adverse Reactions (SARs)|To assess the occurrence of serious adverse reactions (SARs) related to CP transfusion in Ebola patients|30 days||||SARs|||Number
2585635|NCT02343081|Primary|Cmax|Rate of absorption of Temozolomide (Cmax) will be measured after the oral administration of the test product (Dralitem®, Monte Verde S.A.) or the reference product (Temodal®, Schering-Plough).|0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0, 10.0 hours on Days 3 and 4|All those subjects who completed the study and were compliant with all the protocol procedures were considered evaluable for statistical pharmacokinetic analysis. Those who received at least one dose of the products under study but did not comply with the study procedures were included in the safety analysis only.|||mcg/mL||Standard Deviation|Mean
2585636|NCT02343003|Other Pre-specified|Medication Usage|Reduction in pain medication usage from baseline as measured by subject self-reported average daily dosage.|6 months and 12 months|17 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 25 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome. 12 months: 17/76 in Cooled radiofrequency group and 2/75 in Corticosteroid injection group completed.|||milligrams||Standard Deviation|Mean
2585637|NCT02343003|Other Pre-specified|Subject Satisfaction - Number of Participants With a Global Perceived Effect Score of 5 or Greater|"Subject satisfaction as measured by the Global Perceived Effect Score at 6 months and 12 months. The study subjects' perception of treatment effect was reflected by the Global Perceived Effect (GPE). The Global Perceived Effect is a 7-point scale: 1 point = worst ever, 2 points = much worse, 3 points = worse, 4 points = not improved but not worse, 5 points = improved, 6 points = much improved, 7 points = best ever."|6 months and 12 months|58 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 67 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome. 12 months: 52/76 in Cooled radiofrequency group and 4/75 in Corticosteroid injection group completed.|||Participants|||Count of Participants
2585638|NCT02343003|Secondary|Oxford Knee Score|"Improvement in global outcome from baseline as measured by the Oxford Knee Score at 6 months and 12 months. The Oxford Knee Score is determined by a 12-question survey that measures knee function, and is scored on a scale that ranges from 0 - 48 points, with scores of 0 - 19 = severe arthritis, 20 - 29 = moderate to severe arthritis, 30 - 39 = mild to moderate arthritis, and 40 - 48 = satisfactory joint function."|6 months and 12 months|58 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 67 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome. 12 months: 52/76 in Cooled radiofrequency group and 3/75 in Corticosteroid injection group completed.|||units on a scale||Standard Deviation|Mean
2585639|NCT02343003|Secondary|Numeric Rating Scale|"The number of subjects whose knee pain is reduced from baseline by ≥ 50% based on the Numeric Rating Scale (NRS) at 12 months. The NRS is an 11-point scale (0 points to 10 points), where 0 points equals no pain and 10 points equals the worst pain."|12 months|52 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 12 month outcome. 4 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 12 month outcome.|||Participants|||Count of Participants
2585640|NCT02343003|Primary|Safety: Number of Subjects Experiencing Adverse Events Through Final Follow up.|Safety Endpoint: Number of subjects experiencing adverse events through final follow up.|6 months and 12 months||||Participants|||Count of Participants
2585641|NCT02343003|Primary|Numeric Rating Scale (NRS)|"The number of subjects whose knee pain is reduced by ≥ 50% based on the Numeric Rating Scale (NRS). The NRS is an 11-point scale (0 points to 10 points), where 0 points equals no pain and 10 points equals the worst pain."|6 months|58 of the 76 originally-randomized study subjects in the Cooled radiofrequency group completed this 6 month outcome. 68 of the originally-randomized 75 study subjects in the Corticosteroid injection group completed this 6 month outcome.|||Participants|||Count of Participants
2585642|NCT02342886|Primary|Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Per Protocol [PP] Population)|"Patients were classified as having a favorable, unfavorable or unassessable status at 12 months from the start of therapy.~A favourable status was a negative culture status at 12 months from start of therapy in patients who had not already been classified as having an unfavorable outcome, and whose last positive culture result was followed by at least 2 negative culture results. Patients with an unfavorable status did not achieve/maintain culture negative status, or previously had culture negative status who following EOT, had 2 positive cultures, or had a positive culture not followed by 2 negative cultures, or died from any cause during treatment (except accidental cause not including suicide), or were dying from TB related causes during follow-up, or required a restart or change of treatment because of an unfavorable outcome with or without bacteriological confirmation, ie, on bacteriological, radiographic or clinical grounds."|From Day 1 to Month 12.|The PP population consisted of the MITT population, excluding patients who were lost to follow-up/withdrawn, had modified/extended treatment for reasons other than unfavourable therapeutic response, did not receive adequate amount of allocated study regimen and patients with major protocol deviations, unless already classified as unfavourable.|||Participants|||Count of Participants
2585643|NCT02342886|Primary|Incidence of Combined Bacteriologic Failure or Relapse or Clinical Failure at Month 12 From Start of Therapy (Day 1) (Modified Intent to Treat [MITT] Population)|"Patients were classified as having a favorable, unfavorable or unassessable status at 12 months from the start of therapy.~A favourable status was a negative culture status at 12 months from start of therapy in patients who had not already been classified as having an unfavorable outcome, and whose last positive culture result was followed by at least 2 negative culture results. Patients with an unfavorable status did not achieve/maintain culture negative status, or previously had culture negative status who following end of treatment (EOT), had 2 positive cultures, or had a positive culture not followed by 2 negative cultures, or were dying from any cause during treatment (except accidental cause not including suicide), or were dying from TB related causes during follow-up, or required an extension, restart or change of treatment except for reinfection/pregnancy, or failed to complete adequate treatment who were unassessable at 12 months or lost to follow-up/withdrawn before EOT."|From Day 1 to Month 12.|The MITT population included all randomized patients excluding late screening failures, lost to follow-up/withdrawn patients who were culture negative, pregnancy, accidental death during treatment, death during follow-up without TB relapse evidence, re-infection with new TB strain + missing/contaminated Month 12 sputum sample.|||Participants|||Count of Participants
2585652|NCT02342704|Secondary|Change From Baseline in SDMT at Week 52|The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.|Baseline, Week 52|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had both baseline and post-baseline values.|||units on a scale||Standard Deviation|Mean
2585653|NCT02342704|Secondary|Change From Baseline in Symbol Digit Modalities Test (SDMT) at Week 24|The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.|Baseline, Week 24|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had both baseline and post-baseline values.|||units on a scale||Standard Deviation|Mean
2585654|NCT02342704|Secondary|Time to Complete Recovery From First Relapse|12-week confirmed complete EDSS recovery from first on-treatment relapse is defined as an EDSS score that is equal to or lower than the last pre-relapse EDSS score and sustained for at least 12 weeks.|Up to Week 52|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2585655|NCT02342704|Secondary|Cumulative Risk of Relapse|A clinical relapse was defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement.|Up to Week 52|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2585656|NCT02342704|Secondary|Time to First Relapse|A clinical relapse was defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement.|Up to Week 52|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2585657|NCT02342704|Secondary|Proportion of Participants With No Evidence of Disease Activity (NEDA)|NEDA was defined as all of the following: no relapses; no 12-week confirmed disability progression based on Expanded Disability Status Scale (EDSS; defined as an increase of 1.0 or more on the EDSS from baseline of 1.0 or more, or an increase of 1.5 or more from a baseline score of 0) that was sustained for 12 weeks; no new T1-Gd+ lesions on brain MRI. No new or enlarging T2-hyperintense lesions.|Up to Week 52|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2585658|NCT02342704|Secondary|Cumulative Number of New or Enlarging T2 Lesions||Baseline, Week 24|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had an assessment.|||lesions||Standard Deviation|Mean
2585659|NCT02342704|Secondary|Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 52|As assessed by MRI.|Baseline, Week 52|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had an assessment.|||percentage change||Standard Deviation|Mean
2585660|NCT02342704|Secondary|Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 24|As assessed by magnetic resonance imaging (MRI).|Baseline, Week 24|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and had an assessment.|||percentage change||Standard Deviation|Mean
2585661|NCT02342704|Secondary|Cumulative Number of New T1-Gd+ Lesions||Baseline, Week 4, Week 12, Week 24|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment.|||lesions||Standard Deviation|Mean
2585662|NCT02342704|Primary|Cumulative Number of ≥ 6-Month Confirmed T1-Hypointense Lesions Arising From New On-Treatment T1-Gadolinium-Enhancing (Gd+) Lesions||Up to Week 52|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2585663|NCT02342678|Secondary|Patient Perception of Bladder Condition|"Change in questionnaire score for Patient Perception of Bladder Condition. Range 1-6, with higher score mean worse function.~Analysis of covariance models were developed to examine change in quality of life outcomes over 3 months. Results were summarized using least square mean estimates of changes in quality of life outcomes in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values."|Baseline to 3 months||||scores on scale||95% Confidence Interval|Least Squares Mean
2585664|NCT02342678|Secondary|Urogenital Distress Inventory-6|"Change in the questionnaire score for Urogenital Distress Inventory-6. Range 0-100, with higher scores mean worse function.~Analysis of covariance models were developed to examine change in quality of life outcomes over 3 months. Results were summarized using least square mean estimates of changes in quality of life outcomes in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values."|Baseline to 3 months||||Scores on scale||95% Confidence Interval|Least Squares Mean
2585694|NCT02342314|Secondary|PD: Maximum Glucose Increase (Gmax) of Part A||Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours|All randomized participants who received at least one dose of study drug and had evaluable PD data.|||mg/dL||Geometric Coefficient of Variation|Geometric Mean
2585665|NCT02342678|Secondary|Incontinence Impact Questionnaire|"Change in questionnaire score for Incontinence Impact Questionnaire. Range 0-400, with higher scores mean worse function.~Analysis of covariance models were developed to examine change in quality of life outcomes over 3 months. Results were summarized using least square mean estimates of changes in quality of life outcomes in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values."|Baseline to 3 months||||scores on scale||95% Confidence Interval|Least Squares Mean
2585666|NCT02342678|Secondary|Total Nighttime Incontinence|Change in frequency of total nighttime incontinence Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.|Baseline to 3 months||||Episodes per day||95% Confidence Interval|Least Squares Mean
2585667|NCT02342678|Secondary|Total Daytime Incontinence|Change in frequency of total daytime incontinence Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.|Baseline to 3 months||||Episodes per day||95% Confidence Interval|Least Squares Mean
2585668|NCT02342678|Secondary|Urgency-type Incontinence|Change in frequency of urgency-type incontinence Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.|Baseline and 3 months||||Episodes per day||95% Confidence Interval|Least Squares Mean
2585669|NCT02342678|Secondary|Stress-type Incontinence Frequency|Change in the frequency of stress-type incontinence episodes Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.|Baseline and 3 Months||||Episodes per day||95% Confidence Interval|Least Squares Mean
2585670|NCT02342678|Primary|Total Incontinence Frequency|Change in the frequency of urinary incontinence episodes of any type. Analysis of covariance models were developed to examine change in incontinence frequency over 3 months. Results were summarized using least square mean estimates of changes in incontinence frequency in each group, as well as estimates of between-group difference in change in outcomes. Main efficacy analyses included all participants regardless of drop-out or adherence, consistent with an intention-to-treat principle. To address the potential for bias stemming from missing bladder diary data for up to 16% of participants who dropped out of interventions early, a multiple imputation procedure (SAS PROC MI, SAS Institute, Inc.) was used to impute values for data missing at follow-up. Imputation models included outcomes, randomization group, and baseline values.|Baseline and 3 months||||episodes per day||95% Confidence Interval|Least Squares Mean
2585671|NCT02342561|Secondary|Description of Bacterial Skin Flora|Macroscopically unique colonies are isolated and analysed using Matrix-Assisted Laser Desorption/Ionization Time Of Flight analysis (MALDI-TOF). Finding are reported as prevalence of unique organism growth in the study population|Samples collected 75 minutes after drape application are analysed||||No. of cases|||Number
2585672|NCT02342561|Primary|Bacterial Quantity|The bacterial quantity of the skin in sampled using the cylinder sampling method and incubated for 36-48 hours. Manually counted growth is reported as log10 Colony forming units (CFU)/cm^2|Measured after skin disinfection and 75 minutes after drape application||||Log10 CFU/cm^2||Inter-Quartile Range|Median
2585673|NCT02342548|Secondary|Absolute Value in Clinical Global Impression of Improvement (CGI-I) Score|"The Clinical Global Impression of Improvement (CGI-I) is a global measure of improvement or change based on the clinician's assessment of all available clinical data obtained from interviewing the participant. The CGI-I consists of a single 7-point rating of total improvement or change from baseline severity, regardless of whether or not the change is due entirely to drug treatment. Raters select 1 response based on the following question, Compared to your participant's condition at the beginning of treatment, how much has he/she changed? Scores are: 1: Very much improved; 2: Much improved; 3: Minimally improved; 4: No change; 5: Minimally worse; 6: Much worse; or 7: Very much worse."|Month 6 and Month 12|Full analysis set (FAS) included all participants who had an open-label extension study baseline efficacy evaluation and completed at least Week 2 visit with a valid UHDRS TMS score, and took >=1 dose of open-label study medication.|||units on a scale||Standard Deviation|Mean
2585674|NCT02342548|Secondary|Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Maximum Chorea (TMC) Score|The UHDRS is a clinical rating scale developed to provide a uniform assessment of the clinical features and course of Huntington's disease (HD). The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. Total Maximum Chorea (TMC) is a subset of the TMS assessment, and composed of the scoring of 7 chorea assessments (face, orobuccolingual, trunk, right and left upper extremities, right and left lower extremities). Each assessment is rated from 0 to 4 (absent to prolonged). TMC is obtained by adding up each of the separate scores, leading to max score of 28. The minimum score is 0. The higher the score, the worse the symptoms.|Baseline (Day 1), Month 6, and Month 12|Full analysis set (FAS) included all participants who had an open-label extension study baseline efficacy evaluation and completed at least Week 2 visit with a valid UHDRS TMS score, and took >=1 dose of open-label study medication.|||Units on a scale||Standard Deviation|Mean
2585675|NCT02342548|Secondary|Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score|The UHDRS is a clinical rating scale developed to provide a uniform assessment of the clinical features and course of Huntington's disease (HD). The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. Total Motor Score (TMS) assesses motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural ability. The total motor impairment scores was the sum of all the individual 31 motor sub-items (each rated from 0 to 4), with higher scores indicating more severe motor impairment than lower scores. The range of TMS is 0-124.|Baseline (Day 1), Month 6, and Month 12|Full analysis set (FAS) included all participants who had an open-label extension study baseline efficacy evaluation and completed at least Week 2 visit with a valid UHDRS TMS score, and took >=1 dose of open-label study medication.|||units on a scale||Standard Deviation|Mean
2585676|NCT02342548|Primary|Number of Participants in Each Columbia Classification Algorithm of Suicide Assessment (C-CASA) Category|Columbia Suicide Severity Rating Scale (C-SSRS) was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior, and was used in this study. C-SSRS responses were mapped onto the Columbia Classification Algorithm of Suicide Assessment (C-CASA). Number of participants with any of the following behaviors occurring since last visit was summarized: completed suicide; suicide attempt; preparatory acts towards suicide; suicidal ideation; self-injurious behavior (no suicidal intent).|Baseline (Day 1), Weeks 2 and 4, Months 3, 6, 9 and 12, follow-up visit (7-14 days after the last dose of Month 12)|The analysis population included all participants who entered the extension study with at least 1 dose of study medication, and with available data for at least 1 time point.|||Participants|||Count of Participants
2585677|NCT02342548|Primary|Number of Participants With Adverse Events Related to Extrapyramidal Symptoms by Severity|Adverse events related to extrapyramidal symptoms included dystonia, akathisia, tardive dyskinesia). Severity was assessed by the investigator. Mild means the AE didn't interfere with the participant's usual function. Moderate means the AE interfered to some extent the participant's usual function. Severe means the AE interfered significantly with the participant's usual function.|1 year|Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication.|||Participants|||Count of Participants
2585678|NCT02342548|Primary|Number of Participants With Laboratory Test Abnormalities (Normal Baseline)|The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, absolute total neutrophils, eosinophils, monocytes, basophils, and lymphocytes), chemistry (blood urea nitrogen/urea, creatinine, glucose, glycosylated hemoglobin [diabetics only], calcium, phosphorus, magnesium, creatine kinase, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein), urinalysis (color, appearance, specific gravity, pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, and microscopy), and other tests (follicle stimulating hormone, urine drug screen, urine pregnancy [human chorionic gonadotropin, hCG], serum beta hCG). Abnormality was determined by the investigator.|1 year|Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication.|||Participants|||Count of Participants
2585679|NCT02342548|Primary|Number of Participants With Abnormal White Blood Cell Count and Absolute Neutrophil Count (Without Regard to Baseline Abnormality)|Number of participants with white blood cell (WBC) count and absolute neutrophil count (ANC) meeting the following criteria is presented: (1) WBC count <0.6 *the lower limit of normal (LLN); (2) WBC count >1.5 times the upper limit of normal (ULN); (3) ANC <0.8*LLN; and (4) ANC >1.2*ULN.|1 year|The analysis population included all participants who entered the extension study with at least 1 dose of study medication, and with available data for at least 1 category.|||Participants|||Count of Participants
2585680|NCT02342548|Primary|Number of Participants With Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria|Maximum absolute values and increases from baseline were summarized for PR interval (interval between the start of the ECG P wave and the start of the QRS complex corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization), QRS complex (time from Q wave to the end of the S wave corresponding to ventricular depolarization), and QTcF interval (time from ECG Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia's formula). Number of participants with ECG data meeting the following criteria is presented: (1) PR interval >=300 msec; (2) QRS complex >=140 msec; (3) QTcF interval: 450 to <480 msec; (4) QTcF interval: 480 to <500 msec; (5) QTcF interval >=500 msec; (6) PR interval increase from baseline >=25/50 percent; (7) QRS complex increase from baseline >=50 percent; (8) QTcF interval increase from baseline: 30 to <60 msec; (9) QTcF interval increase from baseline >=60 msec.|1 year|The analysis population included all participants who entered the extension study with at least 1 dose of study medication, and with available data for at least 1 category.|||Participants|||Count of Participants
2585695|NCT02342314|Secondary|PD Absolute Maximum Blood Glucose of Part B||Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours|All participants who received at least one dose of study drug or placebo and have evaluable PD data.|||mg/dL||Geometric Coefficient of Variation|Geometric Mean
2585696|NCT02342314|Secondary|Pharmacodynamic (PD): Absolute Maximum Blood Glucose of Part A||Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours|All participants who received at least one dose of study drug or placebo and have evaluable PD data.|||milligram/deciliter (mg/dL)||Geometric Coefficient of Variation|Geometric Mean
2585681|NCT02342548|Primary|Number of Participants With Vital Signs Data Meeting Categorical Summarization Criteria|Number of participants with vital signs data meeting the following criteria is presented: (1) supine systolic blood pressure (SBP) <90 millimeters of mercury (mmHg); (2) standing SBP <90 mmHg; (3) supine diastolic blood pressure (DBP) <50 mmHg; (4) standing DBP <50 mmHg; (5) supine pulse rate <40 beats per minute (bpm); (6) supine pulse rate >120 bpm; (7) standing pulse rate <40 bpm; (8) standing pulse rate >140 bpm; (9) maximum increase from baseline in supine SBP >= 30 mmHg; (10) maximum increase from baseline in standing SBP >= 30 mmHg; (11) maximum increase from baseline in supine DBP >= 20 mmHg; (12) maximum increase from baseline in standing DBP >= 20 mmHg; (13) maximum decrease from baseline in supine SBP >=30 mmHg; (14) maximum decrease from baseline in standing SBP >=30 mmHg; (15) maximum decrease from baseline in supine DBP >=20 mmHg; (16) maximum decrease from baseline in standing DBP >=20 mmHg.|1 year|The analysis population included all participants who entered the extension study with at least 1 dose of study medication, and with available data for at least 1 category.|||Participants|||Count of Participants
2585682|NCT02342548|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)|The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, absolute total neutrophils, eosinophils, monocytes, basophils, and lymphocytes), chemistry (blood urea nitrogen/urea, creatinine, glucose, glycosylated hemoglobin [diabetics only], calcium, phosphorus, magnesium, creatine kinase, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein), urinalysis (color, appearance, specific gravity, pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, and microscopy), and other tests (follicle stimulating hormone, urine drug screen, urine pregnancy [human chorionic gonadotropin, hCG], serum beta hCG). Abnormality was determined by the investigator.|1 year|Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication.|||Participants|||Count of Participants
2585683|NCT02342548|Primary|Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study treatment and up to 28 calendar days after the last administration of study treatment that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs.|1 year|Safety analysis population included all participants who entered the extension study with at least 1 dose of study medication.|||Participants|||Count of Participants
2585684|NCT02342535|Primary|Change in Physical Activity (Minutes/Week)|To test for differences in physical activity, we used mixed-effects models for pre- and post-intervention accelerometer data. In these models, the outcome was daily minutes of bout corrected moderate-vigourous physical activity. Time (pre/post-intervention) was treated as a binary variable in order to measure changes in physical activity. Models controlled for accelerometer wear time and weekend day.|Baseline and 4 months|We did not collect any data from the children, so all the data analysis is from the data obtained from the 30 mothers. To test for differences in physical activity, we used mixed-effects models for pre- and post-intervention accelerometer data. In these models, the outcome was daily minutes of bout corrected moderate-vigourous physical activity.|||minute/week activity||Standard Deviation|Mean
2585685|NCT02342418|Secondary|This Outcome Measure is the Maximum Plasma Concentration of Tedizolid in Morbidly Obese Subjects Compared to Nonobese Subjects|The maximum concentration or Cmax value is measured in units of milligrams of tedizolid per liter of plasma.This comparison was made between the two groups of subjects that included morbidly obese subjects to matched non-obese subjects.|12 months||||Milligram per Liter||Full Range|Mean
2585686|NCT02342418|Primary|This Outcome Measure is the Tedizolid Area Under the Concentration Time-curve From Time 0 to 72 Hours in Morbidly Obese Subjects and Matched Non-obese Subjects.|The area under the concentration-time curve is measured in units of mg of tedizolid per liter of plasma multiplied by time in hours (hour*mg/L) from time 0 to 72 hours. This comparison was made between the two groups of subjects that included morbidly obese subjects to matched non-obese subjects.|12 months||||hour*milligram/Liter||Full Range|Median
2585687|NCT02342379|Secondary|Progression Free Survival|"Progression of disease by RANO criteria:~The RANO criteria divides response into four types of response based on imaging and clinical features~complete response~partial response~stable disease~progression"|4 months|3 of the enrolled participants were not evaluable|||Number of participants|||Number
2585688|NCT02342379|Primary|Number of Patients With Adverse Events|Safety lab tests and adverse event assessment|4 months||||Participants|||Count of Participants
2585689|NCT02342314|Secondary|QTcF Change From Baseline of Part B||Baseline, 8 hours after drug administration|All randomized participants who received at least one dose of study drug and had evaluable QTcF data.|||milliseconds (msec)||Standard Deviation|Mean
2585690|NCT02342314|Secondary|QT Interval as Corrected by the Fridericia Method (QTcF) Change From Baseline of Part A||Baseline, 8 hours after drug administration|All randomized participants who received at least one dose of study drug and who had evaluable QTcF data.|||milliseconds (msec)||Standard Deviation|Mean
2585691|NCT02342314|Secondary|PD: Gtmax of Part B||Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours|All randomized participants who received at least one dose of study drug and had evaluable PD data.|||hour||Full Range|Median
2585692|NCT02342314|Secondary|PD: Time to Maximum Blood Glucose (Gtmax) of Part A||Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours|All randomized participants who received at least one dose of study drug and had evaluable PD data.|||hour||Full Range|Median
2585693|NCT02342314|Secondary|PD: Gmax of Part B||Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours|All randomized participants who received at least one dose of study drug and had evaluable PD data.|||mg/dL||Geometric Coefficient of Variation|Geometric Mean
2596372|NCT02209610|Primary|Muscle Afferent Affect|Corticospinal responsiveness will be quantified before and after exercise.|1 minute after exercise on study day||||percent change||Standard Error|Mean
2585699|NCT02342314|Secondary|PK: AUC(0-∞) of Part B||Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2585700|NCT02342314|Secondary|PK: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Part A||Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2585701|NCT02342314|Secondary|PK: Cmax of Part B||Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2585702|NCT02342314|Secondary|Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Part A||Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2585703|NCT02342314|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|Baseline to Study Completion (Up to 84 Days)|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2585704|NCT02342288|Secondary|Change and Correlations in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients|The secondary outcome is to evaluate factors (age, gender, duration of procedure, blood loss, intraoperative fluids, blood pressure, and carbon dioxide levels) looking for correlations with intraocular pressure changes.|prone; every 15 minutes; 1 hr until end of surgery|||||||
2585705|NCT02342288|Primary|Change in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients Head Raised 10 Degrees or Kept in Neutral Position|The objective is to determine if slight elevation of the head (10 degrees up from neutral) can decrease the IOP compared to remaining in neutral position (standard of care) for the entire surgery. The mean values for Δ IOP measurements (i.e. two eye average maximum IOP - two eye average baseline IOP obtained at first prone measurement).|Prone; 5 minutes after head raised to 10 degrees; every 15 minutes; 1 hr until end of surgery|Subjects who were undergoing elective lumbar spine surgery.|||mm Hg||95% Confidence Interval|Mean
2585706|NCT02342223|Secondary|Dermatology Life Quality Index (DLQI)|"To evaluate the effects of Voluma injections on the subject's quality of life (QOL) using the Dermatology Life Quality Index (DLQI). The DLQI is a validated 10-item questionnaire encompassing six different domains of QOL, including symptoms and feelings, daily activities, leisure, work/school, personal relationships, and treatment. Each question has four possible responses: not at all/not relevant, a little, a lot, and very much that corresponds to scores of 0, 1, 2, and 3, respectively, and a higher score suggests a higher level of QOL impairment. DLQI total score may range between 0 to 30."|Baseline to 12 months||||scores on a scale||Standard Deviation|Mean
2585707|NCT02342223|Secondary|Subject Satisfaction Questionnaire (SSQ)|To evaluate the benefits and effects of Voluma injections on HIV-associated facial lipoatrophy as evidenced by the subject satisfaction questionnaire.|12 months||||percentage of total participants|||Number
2585708|NCT02342223|Secondary|Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Participants|To evaluate the effectiveness of Voluma injections as a treatment for HIV-associated facial lipoatrophy over 12 months by assessing changes in the Global Aesthetic Improvement Scale (GAIS) based on pre- and post- treatment photography by participants.|Baseline to 12 months||||Participants|||Number
2585709|NCT02342223|Secondary|Number of Participants Achieving Grade 1 in the Carruthers Lipoatrophy Severity Scale (CLSS)|To evaluate the effectiveness of Voluma injections as a treatment for HIV-associated lipoatrophy over 12 months by assessing changes in the Carruthers Lipoatrophy Severity Scale (CLSS) based on pre/post intervention photography by principal investigator (PI). CLSS is a 4-point grading scale (1 to 4, with a greater number indicating higher severity of HIV FLA). Grade 1: mild and localized facial lipoatrophy. Grade 2: deeper and longer atrophy, with the facial muscles beginning to show through. Grade 3: atrophic area is even deeper and wider, with the muscles clearly showing. Grade 4: lipoatrophy covers a wide area, extending up toward the eye sockets, and the facial skin lies directly on the muscles.|Baseline to 12 months||||Participants|||Number
2585710|NCT02342223|Primary|Percentage of Participants With Device or Procedure Related Adverse Events|To evaluate the safety of Voluma injections as a treatment for HIV-associated facial lipoatrophy over 12 months by monitoring the incidence of adverse events (patient will keep a daily diary for initial 1 month and weekly phone calls will be made by study coordinator for initial 1 month to document possible adverse events, including injection site reactions, redness, bruising, swelling, and induration).|12 months|Common, transient adverse events reported in subject diaries include as follows.|||percentage of total participants|||Number
2585711|NCT02342223|Primary|Number of Participants Rated Very Much Improved on the Global Aesthetic Improvement Scale (GAIS) by Prinicple Investigator|"To evaluate the effectiveness of Voluma injections as a treatment for HIV-associated facial lipoatrophy over 12 months by assessing changes in the Global Aesthetic Improvement Scale (GAIS) based on pre- and post-treatment photography by principal investigator (PI). GAIS is a 5-point rating scale, ranging from worse, no change, improved, much improved, and very much improved."|Baseline to 12 months||||participants|||Number
2585712|NCT02342197|Primary|Number of Oocytes Retrieved||12 months||||oocytes||Standard Deviation|Mean
2585713|NCT02342171|Secondary|Mortality Risk Factor: Age|To determine age as risk factor for mortality despite administration of CP.|30 days|Pre-specified sub-group comparison|||Participants|||Count of Participants
2585714|NCT02342171|Secondary|Mortality Risk Factor: Ct|To determine Ct as risk factor for mortality despite administration of CP.|30 days|Pre-specified sub-group comparison|||Participants|||Count of Participants
2585715|NCT02342171|Secondary|Number of Professional Safety Incidents|To assess the occurrence of safety risks related to CP transfusion in health workers administering the treatments. This will be observed throughout the study|9 months|Overall Number of Participants Analyzed refers to health workers administering CP; not to the participants receiving CP.|||Professional safety incidents|||Number
2585717|NCT02342171|Secondary|Number of Participants Who Died Corresponding to EV Antibody Levels (Neutralizing Antibodies)|To assess the relationship between EVD antibody levels (neutralizing antibodies) and death in patients who received CP|14 days|Overall Number of Participants Analyzed divided in 3 equal groups depending on total dose of antibodies. Children (<16 years) were excluded from analysis as dosing of CP was done according to body weight, which was not recorded for many adult patients.|||Participants|||Count of Participants
2585718|NCT02342171|Secondary|Number of Participants Who Died Corresponding to EV Antibody Levels (Anti-EBOV IgG)|To assess the relationship between EVD antibody levels (anti-EBOV IgG) and death in patients who received Convalescent Plasma|14 days|Overall Number of Participants Analyzed divided in 3 equal groups depending on total dose of antibodies. 71 out of 84 participants were defined as the analysis population. Children (<16 years) were excluded from analysis as dosing of CP was done according to body weight, which was not recorded for many adult patients.|||Participants|||Count of Participants
2585719|NCT02342171|Secondary|Titer of Ebola Viral RNA|"To assess the relationship between EVD antibody levels (neutralizing antibodies) in donated plasma and the changes in levels of viral RNA in patients who received Convalescent Plasma.~The outcome shows the overall association between antibody dose category and change in Cycle threshold (Ct) value pre and post transfusion (Ct is the number of cycles that have to be run before reaching a threshold value of a positive result)."|30 days|"Total dose for antibody levels was categorized in three equal-sized groups (tertiles), with the lowest dose category as reference.~71 out of 84 participants were defined as the analysis population. Children (<16 years) were excluded from the analysis as dosing of CP was done according to body weight, which was not recorded for many adult patients."|||Cycles||95% Confidence Interval|Mean
2585720|NCT02342171|Secondary|Titer of Ebola Viral RNA|"To assess the relationship between EVD antibody levels (EBOV IgG) in donated plasma and the changes in levels of viral RNA in patients who received Convalescent Plasma.~The outcome shows the overall association between antibody dose category and change in Cycle threshold (Ct) value pre and post transfusion (Ct is the number of cycles that have to be run before reaching a threshold value of a positive result)."|30 days|"Total dose for antibody levels was categorized in three equal-sized groups (tertiles), with the lowest dose category as reference.~71 out of 84 participants were defined as the analysis population. Children (<16 years) were excluded from the analysis as dosing of CP was done according to body weight, which was not recorded for many adult patients."|||Cycles||95% Confidence Interval|Mean
2585721|NCT02342171|Secondary|Number of Participants With 30 Days Survival|Effect of convalescent plasma in improving patients survival at day 30|30 days|"Outcome was only measured in the intervention group. Data (historical) not available for Standard care group."|||Participants|||Count of Participants
2585722|NCT02342171|Primary|Survival at Day 14 After Start of Intervention|Effect of convalescent plasma in improving patients survival at day 14; it will be considered clinically significant if there is an absolute decrease in the case fatality rate of 20% or more, compared to SC alone|14 days||||Participants|||Count of Participants
2585723|NCT02341859|Secondary|Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of lens preferences for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Which lens is preferred)|6 hours|Preference is missing for 1 participant in the stenfilcon A/delefilcon A group whom did not answer preference question of which lens is preferred.|||participants|||Number
2585724|NCT02341859|Secondary|Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of overall wearing satisfaction for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-100, 0=very poor, 100=very satisfied).|6 hours||||units on a scale||Standard Deviation|Mean
2585725|NCT02341859|Secondary|Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of vision for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot see due to blur vision, 100=clear vision without any blur image).|Baseline, 3 hours, 6 hours||||units on a scale||Standard Deviation|Mean
2585726|NCT02341859|Secondary|Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of handling for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (ease of insertion) and 6 hours (ease of removal). (Scale 0-100, 0=cannot handle at all, 100=no problem at all).|Baseline and 6 hours||||units on a scale||Standard Deviation|Mean
2585727|NCT02341859|Secondary|Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of comfort for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no lens feeling).|Baseline, 3 hours, 6 hours||||units on a scale||Standard Deviation|Mean
2585728|NCT02341859|Secondary|Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of dryness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline, 3 hours, and 6 hours. (Scale 0-100, 0=cannot wear, 100= no dryness).|Baseline, 3 hours, 6 hours||||units on a scale||Standard Deviation|Mean
2585729|NCT02341859|Secondary|Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of red eye on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|6 hours||||participants|||Number
2585730|NCT02341859|Secondary|Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of itching sensation on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|6 hours||||participants|||Number
2585731|NCT02341859|Secondary|Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of itching sensation on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|Baseline||||participants|||Number
2585732|NCT02341859|Secondary|Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|6 hours||||participants|||Number
2585733|NCT02341859|Secondary|Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Subjective ratings of pain and foreign body sensation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at baseline. 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe)|Baseline||||participants|||Number
2585734|NCT02341859|Primary|Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).|6 hours||||participants|||Number
2585735|NCT02341859|Primary|Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation overall for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Optimal, Almost optimal, Border line to wear, Not acceptable (cannot wear)).|Baseline||||participants|||Number
2585736|NCT02341859|Primary|Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours on removal. (Optimal, Acceptable, No lag, Falls from cornea)|6 hours||||participants|||Number
2585737|NCT02341859|Primary|Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of tightness on up gaze blink lag for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline (insertion). (Optimal, Acceptable, No lag, Falls from cornea)|Baseline||||participants|||Number
2585738|NCT02341859|Primary|Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of post-blink movement on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Tight, Little tight, Optimal, Little loose, Loose)|6 hours||||participants|||Number
2585739|NCT02341859|Primary|Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of post-blink movement on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose)|Baseline||||participants|||Number
2585740|NCT02341859|Primary|Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of vertical centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Up, Little up, Centered, Little low, Low)|6 hours||||participants|||Number
2585741|NCT02341859|Primary|Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of vertical centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Up, Little up, Centered, Little low, Low)|Baseline||||participants|||Number
2585742|NCT02341859|Primary|Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of horizontal centration on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Temporal, Little temporal, Centered, Little nasal, Nasal)|6 hours||||participants|||Number
2585743|NCT02341859|Primary|Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation of horizontal centration on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal)|Baseline||||participants|||Number
2585744|NCT02341859|Primary|Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation for corneal coverage on removal for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours with a 'yes' or 'no'.|6 hours||||participants|||Number
2585745|NCT02341859|Primary|Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Lens fit evaluation for corneal coverage on insertion for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline with a 'yes' or 'no'.|Baseline||||participants|||Number
2585746|NCT02341859|Primary|Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (Wavefront Error Map)|6 hours||||microns||Standard Deviation|Mean
2585747|NCT02341859|Primary|Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal shape change for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group is assessed at 6 hours by the topographer measurement and functions (map function of Tangential Curvature Map)|6 hours||||mm||Standard Deviation|Mean
2585748|NCT02341859|Primary|Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining depth (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|6 hours||||units on a scale||Standard Deviation|Mean
2585749|NCT02341859|Primary|Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining depth for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group A assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|Baseline||||units on a scale||Standard Deviation|Mean
2585750|NCT02341859|Primary|Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining extent (ocular response) for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|6 hours||||units on a scale||Standard Deviation|Mean
2585751|NCT02341859|Primary|Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining extent (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|Baseline||||units on a scale||Standard Deviation|Mean
2585752|NCT02341859|Primary|Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|6 hours||||units on a scale||Standard Deviation|Mean
2585753|NCT02341859|Primary|Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Corneal staining type (ocular response) for for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps, 0=normal, 4=severe) C - central, N - nasal, T- temporal, S - superior, I - interior|Baseline||||units on a scale||Standard Deviation|Mean
2585754|NCT02341859|Primary|Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|6 hours||||units on a scale||Standard Deviation|Mean
2585755|NCT02341859|Primary|Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|"Limbal redness for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe)~N - nasal, T - temporal, S - superior, I - interior"|Baseline||||units on a scale||Standard Deviation|Mean
2585756|NCT02341859|Primary|Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|6 hours||||units on a scale||Standard Deviation|Mean
2585757|NCT02341859|Primary|Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Conjunctival indentation for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|Baseline||||units on a scale||Standard Deviation|Mean
2585758|NCT02341859|Primary|Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at 6 hours. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|6 hours||||units on a scale||Standard Deviation|Mean
2585759|NCT02341859|Primary|Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A|Conjunctival staining for stenfilcon A/delefilcon A group and stenfilcon A/narafilcon A group assessed at baseline. (Scale 0-4, 0.5 steps 0=normal, 4=severe) N - nasal, T - temporal, S - superior, I - interior|Baseline||||units on a scale||Standard Deviation|Mean
2585760|NCT02341599|Primary|Fraction of the Administered Dose of MK-6183 Excreted Unchanged in Urine or Dialysate (Fe)|Fe is the fraction (percentage) of the administered dose that was excreted unchanged in urine (Groups A to D) or dialysate (Group E: Period 1; HD commenced 3 hours after dosing).|Groups A to D (urine): 0 to 24, 24 to 48, and 48 to 72 hours post-dose; Group E (dialysate): 0 to 1, 1 to 2, 2 to 3, and 3 to 4 hours after starting HD|All participants who received MK-6183 and had viable results are included.|||mg||Standard Deviation|Mean
2585761|NCT02341599|Primary|Dialysate Clearance of MK-6183 (CLd)|CLd is the amount of drug cleared from plasma via dialysis. Only data collected during HD (Group E: Period 1) is presented (HD commenced 3 hours after dosing).|0 to 1, 1 to 2, 2 to 3, and 3 to 4 hours after starting HD|All participants who received MK-6183 and had viable results are included. Only data for Group E: Period 1 is presented.|||Liters/hour||Standard Deviation|Mean
2585762|NCT02341599|Primary|Renal Clearance of MK-6183 (CLr)|CLr is the clearance of drug from plasma via the kidneys. Only data from Groups A, B, C, and D is presented; participants in Group E (Period 1) had no detectable urine data. Data for Group E: Period 1 are presented below in the dialysate clearance measure.|0 to 24, 24 to 48, and 48 to 72 hours post-dose|All participants who received MK-6183 and had viable results are included. CLr data are not presented for Group E.|||Liters/hour||Standard Deviation|Mean
2585763|NCT02341599|Primary|Cumulative Amount of MK-6183 Excreted in Urine or Dialysate (Ae)|Ae is the cumulative amount of drug excreted unchanged in urine or dialysate. For Groups A, B, C, and D, Ae was assessed in urine. For Group E: Period 1, Ae was assessed in dialysate (participants in Group E had no detectable urine data) at hourly collection intervals during HD (HD commenced 3 hours after dosing).|Groups A to D (urine): 0 to 24, 24 to 48, and 48 to 72 hours post-dose; Group E (dialysate): 0 to 1, 1 to 2, 2 to 3, and 3 to 4 hours after starting HD|All participants who received MK-6183 and had viable results are included. For Group E, only results from Period 1 are presented as Period 2 sampling occurred post-HD.|||mg||Standard Deviation|Mean
2585764|NCT02341599|Secondary|Number of Participants Discontinuing From the Study Due to an AE|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.|Up to 12 days|All treated participants are included.|||Participants|||Count of Participants
2585765|NCT02341599|Primary|Apparent Plasma Half-life (t½) of MK-6183|t½ is the amount of time required for the plasma concentration of MK-6183 to reduce by 50%. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) [data from Periods 1 and 2 were analyzed separately]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose.|Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dose|All participants who received MK-6183 and had viable results are included. One participant from Group E: Period 1 and 1 participant from Group E: Period 2 were excluded due to implausible concentration values.|||Hours||Standard Deviation|Mean
2585766|NCT02341599|Primary|Volume of Distribution at Steady State (Vss) of MK-6183|Vss is the apparent volume of distribution at steady state for MK-6183. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) [data from Periods 1 and 2 were analyzed separately]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose.|Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dose|All participants who received MK-6183 and had viable results are included. One participant from Group E: Period 1 and 1 participant from Group E: Period 2 were excluded due to implausible concentration values.|||Liters||Standard Deviation|Mean
2585767|NCT02341599|Primary|Apparent Total Body Clearance of MK-6183 From Plasma (CL)|CL is a measure of the clearance of drug from plasma via metabolism and excretion. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) [data from Periods 1 and 2 were analyzed separately]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of plasma sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose.|Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dose|All participants who received MK-6183 and had viable results are included. One participant from Group E: Period 1 and 1 participant from Group E: Period 2 were excluded due to implausible concentration values.|||L/hour||Standard Deviation|Mean
2585768|NCT02341599|Primary|Maximum Plasma Drug Concentration (Cmax) of MK-6183|Cmax is the maximum observed post-dose drug concentration in plasma. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) [data from Periods 1 and 2 were analyzed separately]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose. For statistical analyses, Group A is the reference and LS mean ratios for tests (Groups B to E) are calculated as test/reference; Group E: Period 1 and Group E: Period 2 were also compared.|Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dose|All participants who received MK-6183 and had viable results are included. One participant from Group E: Period 1 and 1 participant from Group E: Period 2 were excluded due to implausible concentration values.|||ug/mL||Standard Deviation|Mean
2585769|NCT02341599|Primary|AUC From Dosing to ∞ (AUC0-∞) of MK-6183|AUC0-∞ is the extrapolated area under the plasma concentration-time curve from the time of dosing to infinity. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) [data from Periods 1 and 2 were analyzed separately]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of plasma sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose. For statistical analyses, Group A is the reference and least squares (LS) mean ratios for tests (Groups B to E) are calculated as test/reference; Group E: Period 1 and Group E: Period 2 were also compared.|Groups A to D & Group E: Period 2: Pre-dose and 0.5, EOI, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dose|All participants who received MK-6183 and had viable results are included. One participant from Group E: Period 1 and 1 participant from Group E: Period 2 were excluded due to implausible concentration values.|||ug*hr/mL||Standard Deviation|Mean
2585770|NCT02341599|Secondary|Number of Participants Experiencing an Adverse Event (AE)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.|Up to 12 days|All treated participants are included.|||Participants|||Count of Participants
2585771|NCT02341599|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Dosing to Last Measurable Concentration (AUC0-last) of MK-6183|AUC0-last is the area under the plasma concentration-time curve from the time of dosing to the last post-dose measurable concentration. Blood samples for Group E were collected both prior to and during HD (Period 1) and after HD (Period 2) [data from Periods 1 and 2 were analyzed separately]. In Period 1, HD commenced 3.5 hours post-dose (HD duration was 3.5 to 4 hours) and sample collection continued until 48 hours post-dose. The specific time frame of plasma sample collection for Group E: Period 1 was pre-dose, 0.5 hours post-dose, EOI, 1.5 hours post-dose, 2 hours post-dose, 3 hours post-dose (pre-HD), 3.5 hours post-dose with HD, 5 hours post-dose with HD, pre-end of HD, 30 min post-HD, 1 hour post-HD, 2 hours post-HD, 12 hours post-dose, 24 hours post-dose, and 48 hours post-dose.|Groups A to D & Group E: Period 2: Pre-dose and 0.5, 1 (end of infusion; EOI), 1.5, 2, 3, 6, 12, 24, 48, and 72 hours post-dose|All participants who received MK-6183 and had viable results are included. One participant from Group E: Period 1 and 1 participant from Group E: Period 2 were excluded due to implausible concentration values.|||ug*hr/mL||Standard Deviation|Mean
2585772|NCT02341495|Secondary|Duration of Remission|The length of time for remission after achieving complete remission|up to 5 years|No patients were analyzed as study was terminated early due to low accrual. Therefore, data necessary for planned analyses were not collected.||||||
2585773|NCT02341495|Secondary|Survival|The overall survival and relapse-free survival functions. Product-limit (Kaplan-Meier) estimate of the survival functions will be estimated, with 90% confidence intervals.|up to 5 years|No patients were analyzed as study was terminated early due to low accrual. Therefore, data necessary for planned analyses were not collected.||||||
2585774|NCT02341495|Secondary|Number of Patients With Adverse Events|Characterization of the safety of an induction regimen of azacitidine in combination with vitamin D and deferasirox (Exjade). The proportion of patients experiencing severe adverse events, and the number of patients experiencing severe adverse events probably or definitely related to treatment will be determined. Adverse events will be tabulated by category and graded by NCI CTCAE version 4.0|up to 5 years|No patients were analyzed as study was terminated early due to low accrual. Therefore, data necessary for planned analyses were not collected.||||||
2585775|NCT02341495|Primary|Complete Remission Rate|The Complete Remission Rate for all evaluable patients will be reported for the following treatment: azacitadine, vitamin D, and deferasirox (Exjade). The proportion of patients experiencing per-protocol CR will be calculated with a 90% exact confidence interval.|up to 5 years|No patients were analyzed as study was terminated early due to low accrual. Therefore, data necessary for planned analyses were not collected.||||||
2585784|NCT02341482|Secondary|Predose Concentration (Ctrough) of PF-04958242||0 hour at Day 1, Day 2, Day 3, Day 4, Day 7, Day 10, Day 13, Day 16, and Day 17 (pre-dose)|All enrolled participants treated who received at least 1 dose of PF-04958242 and had at least 1 measureable concentration.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2585776|NCT02341482|Secondary|Number of Participants With Positive Response to Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced the following: completed suicide (1), suicide attempt (2) (response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (3)(Yes on preparatory acts or behavior), suicidal ideation (4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(Yes on Has participant engaged in non-suicidal self-injurious behavior)."|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
2585777|NCT02341482|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 28 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
2585778|NCT02341482|Secondary|Number of Participants With Significant Change in Physical Examination From Previous Examination|A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
2585779|NCT02341482|Secondary|Number of Participants With Significant Change in Neurological Examination From Previous Examination|The extended neurological examination, performed by a board certified neurologist, included observations for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger, nose, heel, shin, Romberg, tandem walking, positional and gaze evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination included an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function were complemented by the Scale for Assessment and Rating of Ataxia (SARA).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
2585780|NCT02341482|Secondary|Number of Participants With Electrocardiogram Data Meeting Criteria of Potential Clinical Concern|Electrocardiogram (ECG) parameters included time from ECG Q wave to the end of the T wave corresponding to electrical systole (QT) interval, beginning of the P wave until the beginning of the QRS complex (PR) interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) interval, QT interval corrected for heart rate (QTc) interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to (=<)200 msec; QRS interval >=140 msec or >=50% increase from baseline; and QTcF >=450 to <480, 480 to <500 and >=500 msec or >=30 to 60 msec increase and also >=60 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
2585781|NCT02341482|Secondary|Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate more than (<)40 or less than (>)120 beats per minute (bpm); systolic blood pressure (SBP) more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture or DBP <50 mm Hg. IFB = increase from baseline; DFB = decrease from baseline.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
2585782|NCT02341482|Secondary|Number of Participants With Abnormal Clinical Laboratory Measurements|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin and microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (follicle stimulating hormone [FSH], urine cotinine, and urine drug screening).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
2585783|NCT02341482|Secondary|Apparent Oral Clearance (CL/F) of PF-04958242|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.|Day 1 (0,1.5,12,13.5 hours post-dose), Day 2 (0,1.5,12,13.5 hours post-dose), Day 3 (0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose), Day 4, Day 7, Day 10, Day 13, Day 16, Day 17 (0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose) Day 18, Day 19, Day 20, Day 21|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of interest measured.|||milliliters per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
2585785|NCT02341482|Secondary|Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-04958242||Day 1 (0,1.5,12,13.5 hours post-dose), Day 2 (0,1.5,12,13.5 hours post-dose), Day 3 (0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose), Day 4, Day 7, Day 10, Day 13, Day 16, Day 17 (0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose) Day 18, Day 19, Day 20, Day 21|All enrolled participants treated who received at least 1 dose of PF-04958242 and had at least 1 measureable concentration.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2585786|NCT02341482|Secondary|Time for Cmax (Tmax) of PF-04958242|Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.|Day 1 (0,1.5,12,13.5 hours post-dose), Day 2 (0,1.5,12,13.5 hours post-dose), Day 3 (0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose), Day 4, Day 7, Day 10, Day 13, Day 16, Day 17 (0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose) Day 18, Day 19, Day 20, Day 21|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of interest measured.|||hours||Full Range|Median
2585787|NCT02341482|Primary|Maximum Observed Plasma Concentration (Cmax) of PF-04958242|Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.|Day 1 (0,1.5,12,13.5 hours post-dose), Day 2 (0,1.5,12,13.5 hours post-dose), Day 3 (0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose), Day 4, Day 7, Day 10, Day 13, Day 16, Day 17 (0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose) Day 18, Day 19, Day 20, Day 21|All enrolled participants treated who received at least 1 dose of PF-04958242 and had at least 1 measureable concentration.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2585788|NCT02341482|Primary|Area Under the Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval, Where Tau = 12 Hours (AUCtau) of PF-04958242|AUCtau = area under the concentration-time profile from time 0 to time tau, the dosing interval, where tau = 12 hours. Collected at Day 3 for PF-04958242 0.025 mg Arm and Day 17 for PF-04958242 0.025 mg + itraconazole 200 mg Arm.|Day 1 (0,1.5,12,13.5 hours post-dose), Day 2 (0,1.5,12,13.5 hours post-dose), Day 3 (0,0.5,1,1.5,2,3,4,6,8,12 hours post-dose), Day 4, Day 7, Day 10, Day 13, Day 16, Day 17 (0,0.5,1,1.5,2,3,4,5,6,8,12 hours post-dose) Day 18, Day 19, Day 20, Day 21|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of interest measured.|||picogram*hours per milliliter pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2585789|NCT02341456|Secondary|Time to Last Detectable Concentration of Platinum (Tlast) When Given as a 2 Hour Infusion in Combination With Oral AZD1775 and IV Paclitaxel.||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||hours||Full Range|Median
2585790|NCT02341456|Secondary|Time to Peak Plasma Concentration of Platinum (Tmax) When Given as a 2 Hour Infusion in Combination With Oral AZD1775 and IV Paclitaxel.||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||hours||Full Range|Median
2585791|NCT02341456|Secondary|Plasma Concentration of Platinum at the End of Infusion (Ceoi) When Given as a 2 Hour Infusion in Combination With Oral AZD1775 and IV Paclitaxel.||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2585792|NCT02341456|Secondary|Area Under Plasma Concentration-time Curve From 0 to Last Measurable Conc. (AUC0-t) of Platinum Following Single IV Infusion of Carboplatin Over 2 Hours in Combination With Single Oral Dose AZD1775 Alone (Cohort 1a) or With IV Paclitaxel (Cohorts 1 & 2)||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2585793|NCT02341456|Secondary|Peak Plasma Concentration (Cmax) of Platinum Following Single IV Infusion of Carboplatin Over 2 Hours in Combination With Single Oral Dose AZD1775 Alone (Cohort 1a) or With IV Paclitaxel (Cohorts 1 and 2)||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2585794|NCT02341456|Secondary|Time to Last Detectable Concentration of Platinum (Tlast) When Given as a 1 Hour Infusion in Combination With Oral AZD1775 and IV Paclitaxel.||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||hours||Full Range|Median
2585795|NCT02341456|Secondary|Time to Peak Plasma Concentration of Platinum (Tmax) When Given as a 1 Hour Infusion in Combination With Oral AZD1775 and IV Paclitaxel.||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||hours||Full Range|Median
2585796|NCT02341456|Secondary|Plasma Concentration of Platinum at the End of Infusion (Ceoi) When Given as a 1 Hour Infusion in Combination With Oral AZD1775 and IV Paclitaxel.||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2585797|NCT02341456|Secondary|Area Under Plasma Concentration-time Curve From 0 to Last Measurable Conc. (AUC0-t) of Platinum Following Single IV Infusion of Carboplatin Over 1 Hour in Combination With Single Oral Dose AZD1775 Alone (Cohort 1a) or With IV Paclitaxel (Cohorts 1 & 2)||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2585798|NCT02341456|Secondary|Peak Plasma Concentration (Cmax) of Platinum Following Single IV Infusion of Carboplatin Over 1 Hour in Combination With Single Oral Dose AZD1775 Alone (Cohort 1a) or With IV Paclitaxel (Cohorts 1 and 2)||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2585799|NCT02341456|Secondary|Time to Last Detectable Concentration (Tlast) of Paclitaxel When Given in Combination With Oral AZD1775 and IV Carboplatin||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||hours||Full Range|Median
2585800|NCT02341456|Secondary|Time to Maximum Plasma Concentration (Tmax) of IV Paclitaxel When Given in Combination With Oral AZD1775 and IV Carboplatin||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||hours||Full Range|Median
2585801|NCT02341456|Secondary|Plasma Concentration of Paclitaxel at the End of Infusion (Ceoi) When Given Combination With Oral AZD1775 and IV Carboplatin.||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2585802|NCT02341456|Secondary|Area Under the Plasma Concentration-time Curve (AUC0-t) of Paclitaxel Following Single IV Infusion in Combination With Single Dose Oral AZD1775 and IV Carboplatin||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2585803|NCT02341456|Secondary|Peak Plasma Concentration (Cmax) of Paclitaxel Following Single IV Infusion in Combination With Single Dose Oral AZD1775 and IV Carboplatin||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2585804|NCT02341456|Secondary|Plasma Concentration of AZD1775 8 Hours After Administration (C8h) at Steady State in Combination With IV Paclitaxel and Carboplatin (Cohorts 1 and 2) or Carboplatin Alone (Cohort 1a)||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||nM||Geometric Coefficient of Variation|Geometric Mean
2585805|NCT02341456|Secondary|Area Under the Plasma Concentration-time Curve From Zero to the Time of the Last Measurable Concentration (AUC0-t) at Steady State for AZD1775 in Combination With IV Paclitaxel and Carboplatin (Cohorts 1 and 2) or Carboplatin Alone (Cohort 1a)||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
2585806|NCT02341456|Secondary|Time to Maximum Plasma Concentration (Tmax) of AZD1775 at Steady State When Given in Combination With IV Paclitaxel and Carboplatin (Cohorts 1 and 2) or Carboplatin Alone (Cohort 1a)||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||hours||Full Range|Median
2585807|NCT02341456|Secondary|Peak Plasma Concentration (Cmax) of AZD1775 at Steady State When Given in Combination With IV Infusion of Paclitaxel and Carboplatin (Cohorts 1 and 2) or Carboplatin Alone (Cohort 1a)||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||nM||Geometric Coefficient of Variation|Geometric Mean
2585808|NCT02341456|Secondary|Plasma Concentration of AZD1775 8 Hours After Single Dose Administration (C8h) of AZD1775 in Combination With IV Paclitaxel and Carboplatin (Cohorts 1 and 2) or Carboplatin Alone (Cohort 1a)||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||nM||Geometric Coefficient of Variation|Geometric Mean
2585809|NCT02341456|Secondary|Area Under the Plasma Concentration-time Curve From Zero to the Time of the Last Measurable Concentration (AUC0-t) Following Single Dose of AZD1775 in Combination With IV Paclitaxel and Carboplatin (Cohorts 1 and 2) or Carboplatin Alone (Cohort 1a)||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
2585810|NCT02341456|Secondary|Time to Maximum Plasma Concentration (Tmax) of AZD1775 Following Single Dose of AZD1775 in Combination With IV Paclitaxel and Carboplatin (Cohorts 1 and 2) or Carboplatin Alone (Cohort 1a)||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||hours||Full Range|Median
2585811|NCT02341456|Secondary|Peak Plasma Concentration (Cmax) of AZD1775 Following Oral Dose of AZD1775 in Combination With IV Infusion of Paclitaxel and Carboplatin (Cohorts 1 and 2) or Carboplatin Alone (Cohort 1a)||AZ1775:C0D1, C1D1, & C1D3 before AZD1775 dose and at 1,2,4,6&8 hrs postdose. Paclitaxel:C1D1 before paclitaxel infusion & at 1.5,3,4,6&8 hrs after start of infusion Carboplatin:C1D1 before carboplatin infusion &at 1,2,4,6&8 hrs after start of infusion|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||nM||Geometric Coefficient of Variation|Geometric Mean
2585812|NCT02341456|Secondary|Plasma Concentration of AZD1775 8 Hours After Single Dose Administration (C8h) of AZD1775 Monotherapy||PK Samples will be collected in all treatment groups on Cycle 0 Day 1, Cycle 1 Day 1, and Cycle 1 Day 3 before the first (morning) dose of AZD1775 (predose) and at 1, 2, 4, 6, and 8 hours postdose|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||nM||Geometric Coefficient of Variation|Geometric Mean
2585813|NCT02341456|Secondary|Area Under the Plasma Concentration-time Curve From Zero to the Time of the Last Measurable Concentration (AUC0-t) Following Single Dose Administration of AZD1775 Monotherapy||PK Samples will be collected in all treatment groups on Cycle 0 Day 1, Cycle 1 Day 1, and Cycle 1 Day 3 before the first (morning) dose of AZD1775 (predose) and at 1, 2, 4, 6, and 8 hours postdose|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
2585814|NCT02341456|Secondary|Time to Maximum Plasma Concentration (Tmax) of AZD1775 Following Single Dose Administration of AZD1775 Monotherapy||PK Samples will be collected in all treatment groups on Cycle 0 Day 1, Cycle 1 Day 1, and Cycle 1 Day 3 before the first (morning) dose of AZD1775 (predose) and at 1, 2, 4, 6, and 8 hours postdose|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||hours||Full Range|Median
2585815|NCT02341456|Secondary|Peak Plasma Concentration (Cmax) of AZD1775 Following Single Dose Administration of AZD1775 Monotherapy||PK Samples collected in all treatment groups on Cycle 0 Day 1, Cycle 1 Day 1, and Cycle 1 Day 3 before the first (morning) dose of AZD1775 (predose) and at 1, 2, 4, 6, and 8 hours postdose|The pharmacokinetic analysis set consisted of all dosed patients for whom an adequate PK profile was obtained.|||nM||Geometric Coefficient of Variation|Geometric Mean
2585816|NCT02341456|Secondary|Duration of Response|The duration of response is defined as the time in weeks from the date of first documented overall response occurrence of CR or PR, (whichever was recorded first) to the earliest date that progressive disease/death was documented. If progression or death has not been documented, a patient's DoR was censored at the date of last tumour assessment.|Up to 18 months||||Weeks||95% Confidence Interval|Median
2585817|NCT02341456|Secondary|Percentage of Patients With Clinical Benefit|Clinical benefit is defined as achieving complete response, partial response, or stable disease.|Up to 18 months||||Percentage||95% Confidence Interval|Number
2585818|NCT02341456|Secondary|Number of Patients With Clinical Benefit|Clinical benefit is defined as achieving complete response, partial response, or stable disease.|Up to 18 months||||Participants|||Number
2585819|NCT02341456|Secondary|Percentage of Patients With an Objective Response|Objective response is defined as either a complete response or a partial response.|Up to 18 months||||Percentage||95% Confidence Interval|Number
2585820|NCT02341456|Secondary|Number of Patients With an Objective Response|Objective response is defined as either a complete response or a partial response.|Up to 18 months||||Participants|||Number
2585821|NCT02341456|Secondary|Best Overall Response|The number of subjects with best overall response in CR, PR, NE, SD, PD subcategory. Best overall response is calculated based on the overall visit responses from each RECIST assessment.|Up to 18 months|Best overall response was analyzed in the Evaluable-for-Response set, comprised of all patients who received at least one dose of the investigational drug and who had measurable disease at baseline.|||Participants|||Number
2585822|NCT02341456|Primary|Number of Patients With Clinically Important Abnormalities in Vital Signs by Preferred Term|The number of patients with clinically important changes in vital sign TEAEs was analyzed in the safety analysis set which was comprised of all patients who received at least one dose of the investigational drug.|Up to 21 days (1 Cycle)|All patients who received at least one dose of the investigational drug.|||Participants|||Number
2585823|NCT02341456|Primary|Number of Patients With Clinically Important Abnormalities in Clinical Chemistry by Preferred Term|The number of patients with clinically important changes in clinical chemistry TEAEs was analyzed in the safety analysis set which was comprised of all patients who received at least one dose of the investigational drug.|Up to 21 days (1 Cycle)|All patients who received at least one dose of the investigational drug.|||Participants|||Number
2585824|NCT02341456|Primary|Number of Patients With Clinically Important Changes in Haematology and Coagulation TEAEs by System Organ Class and Preferred Term|The number of patients with clinically important changes in haematology and coagulation TEAEs was analyzed in the safety analysis set which was comprised of all patients who received at least one dose of the investigational drug.|Up to 21 days (1 Cycle)|All patients who received at least one dose of the investigational drug.|||Participants|||Number
2585897|NCT02340676|Secondary|Non-relapse Mortality|Participants one year cumulative incidence of Non-relapse mortality was assessed.|From the start of treatment to 1 Year||||percentage of probability||95% Confidence Interval|Number
2585825|NCT02341456|Primary|Number of Patients With Treatment-Emergent Adverse Events During AZD1775 Monotherapy Cycle by System Organ Class and Preferred Term|The number of patients with TEAEs during AZD1775 Monotherapy Cycle was analyzed in the safety analysis set which was comprised of all patients who received at least one dose of the investigational drug.|Up to 1 week|All patients who received at least one dose of the investigational drug.|||Participants|||Number
2585826|NCT02341456|Primary|Number of Treatment-Emergent Adverse Events (TEAE)|The number of treatment-emergent adverse events was counted in the safety analysis set which was comprised of all patients who received at least one dose of the investigational drug.|Up to 21 days (1 Cycle)|All patients who received at least one dose of the investigational drug.|||TEAE|||Number
2585827|NCT02341456|Primary|Number of Patients With Treatment-Emergent Adverse Events|The number of patients with treatment-emergent adverse events was analyzed on the safety analysis set which was comprised of all patients who received at least one dose of the investigational drug.|Up to 21 days (1 Cycle)|All patients who received at least one dose of the investigational drug.|||Participants|||Number
2585828|NCT02341417|Secondary|Change From Day 1 of Cinacalcet Treatment in Serum Phosphorus Over Time|"Change in phosphorus measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356.~Data collected more than 7 days after the last dose of study drug were excluded."|Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit).|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point.|||mg/dL||Inter-Quartile Range|Median
2585829|NCT02341417|Secondary|Change From Day 1 of Cinacalcet Treatment in Serum Corrected Calcium Over Time|"Change in corrected calcium measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356.~Data collected more than 7 days after the last dose of study drug were excluded."|Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit).|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point.|||mg/dL||Inter-Quartile Range|Median
2585830|NCT02341417|Secondary|Percent Change From Day 1 of Cinacalcet Treatment in iPTH Over Time|"Percent change in iPTH measured from the date the initial dose of cinacalcet was administered, either in parent study 20130356 or 20110100, or in the extension study for participants who received SOC only in parent study 20130356.~Data collected more than 7 days after the last dose of study drug were excluded."|Baseline and weeks 3, 7, 11, 15, 17, 18, 19, 20, 23, 27, 31, 35, 39, 43, 48, 52, relative to day 1 of cinacalcet treatment, and at the end of treatment visit and end of study visit (4 weeks after the end of treatment visit).|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point.|||percent change||Inter-Quartile Range|Median
2585831|NCT02341417|Secondary|Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 23 and 28|"The percentage of participants who achieved ≥ 30% reduction in iPTH measured from the date the initial dose of cinacalcet was administered, in parent study 20130356 or 20110100 for participants who received cinacalcet in the parent study, or in the extension study for participants who received SOC only in parent study 20130356.~For participants who did not have an iPTH value during weeks 23 and 28, the mean of the last two available post-baseline values collected at protocol-specified visits was used. If only one post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded."|Baseline and weeks 23 and 28, relative to day 1 of cinacalcet treatment.|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study.|||percentage of participants||95% Confidence Interval|Number
2585832|NCT02341417|Secondary|Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Day 1 of Cinacalcet Treatment to Mean Value During Weeks 11 and 15|"The percentage of participants who achieved ≥ 30% reduction in iPTH measured from the date the initial dose of cinacalcet was administered, in parent study 20130356 or 20110100 for participants who received cinacalcet in the parent study, or in the extension study for participants who received SOC only in parent study 20130356.~Participants who had no iPTH values during weeks 11 and 15 were considered non-responders. Data collected more than 7 days after the last dose of study drug were excluded."|Baseline and weeks 11 and 15, relative to day 1 of cinacalcet treatment.|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study.|||percentage of participants||95% Confidence Interval|Number
2585833|NCT02341417|Secondary|Serum Phosphorus at Baseline, Week 11, and Week 28|Data collected more than 7 days after the last dose of study drug were excluded.|Extension study baseline, week 11 and week 28|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point.|||mg/dl||Inter-Quartile Range|Median
2585834|NCT02341417|Secondary|Serum Corrected Calcium at Baseline, Week 11, and Week 28|Data collected more than 7 days after the last dose of study drug were excluded.|Extension study baseline, week 11 and week 28|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study, with available data at each time point.|||mg/dL||Inter-Quartile Range|Median
2585898|NCT02340676|Secondary|Progression-free Survival|One year overall survival was analyzed|From the start of treatment to 1 Year||||percentage of probability||95% Confidence Interval|Number
2585835|NCT02341417|Secondary|Change From Baseline in Serum Phosphorus to the Mean Value During Weeks 23 to 28|For participants who had no values during weeks 23 to 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded.|Extension study baseline and weeks 23 and 28|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study.|||mg/dL||Inter-Quartile Range|Median
2585836|NCT02341417|Secondary|Change From Baseline in Corrected Serum Calcium to the Mean Value During Weeks 23 to 28|For participants who had no values during weeks 23 to 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded.|Extension study baseline and weeks 23 and 28|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study.|||mg/dL||Inter-Quartile Range|Median
2585837|NCT02341417|Secondary|Percentage of Participants Who Achieved Mean iPTH ≤ 300 pg/mL During Weeks 23 and 28|For participants who had no values during week 23 and 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded.|Weeks 23 and 28|All enrolled participants in the extension study (Study 20140159) who received at least one dose of cinacalcet during the extension study and had at least one assessment after day 1 of the extension study.|||percentage of participants||95% Confidence Interval|Number
2585838|NCT02341417|Secondary|Percent Change From Baseline in iPTH to the Mean Value During Weeks 23 and 28|"This endpoint was analyzed in participants who received SOC only in parent study 20130356.~For participants who had no values during week 23 and week 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was excluded from the analysis. Data collected more than 7 days after the last dose of study drug were excluded."|Extension study baseline and weeks 23 and 28|Enrolled participants from Study 20130356 who did not receive cinacalcet prior to day 1 of the extension study and had ≥ 1 assessment after day 1 of the extension study.|||percent change||Inter-Quartile Range|Median
2585839|NCT02341417|Secondary|Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 23 and 28|"This endpoint was analyzed in participants who received SOC only in parent study 20130356.~For participants who had no values during week 23 and 28, the mean of the last 2 available post-baseline values collected in the dose-titration phase was used. If only 1 post-baseline value was available, this single value was used. If no post-baseline value was available, the participant was considered a non-responder. Data collected more than 7 days after the last dose of study drug were excluded."|Extension study baseline and weeks 23 and 28|Enrolled participants from Study 20130356 who did not receive cinacalcet prior to day 1 of the extension study and had ≥ 1 assessment after day 1 of the extension study.|||percentage of participants||95% Confidence Interval|Number
2585840|NCT02341417|Secondary|Percentage of Participants Achieving ≥ 30% Reduction in iPTH From Baseline to Mean Value During Weeks 11 and 15|"This endpoint was analyzed in participants who received SOC only in parent study 20130356.~Participants who had no iPTH values during weeks 11 or 15 were considered non-responders. Data collected more than 7 days after the last dose of study drug were excluded."|Baseline (defined as the mean values of samples collected during the screening period and day 1 pre-dose in the extension study) and weeks 11 and 15|Enrolled participants from Study 20130356 who did not receive cinacalcet prior to day 1 of the extension study and had ≥ 1 assessment after day 1 of the extension study.|||percentage of participants||95% Confidence Interval|Number
2585841|NCT02341417|Primary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE, v4.0). The investigator assessed whether the adverse event was possibly related to the study drug as indicated by a yes or no response to the question: Is there a reasonable possibility that the event may have been caused by the study drug?"|From first dose of study drug in the extension study up to 4 weeks after the last dose; 32 weeks.|All enrolled participants who received at least one dose of study drug in the extension study.|||Participants|||Count of Participants
2585842|NCT02341144|Secondary|PACU Length of Stay (LOS)|duration of time spent in the post-anesthesia care unit (PACU) from arrival to discharge|from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours||||minutes||Full Range|Median
2585843|NCT02341144|Secondary|PACU Morphine Equivalents|morphine equivalents received in PACU|from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours||||mg/kg||Full Range|Median
2585844|NCT02341144|Secondary|Pain Score of Zero|"proportion who reported a score of zero throughout their PACU stay using the Wong-Baker (WB) scale with zero being no pain"|from entry in the post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours||||Participants|||Count of Participants
2585845|NCT02341144|Secondary|Time to First Narcotic|duration until patient received first dose of narcotic in PACU|from entry in post-anesthesia care unit (PACU) to first narcotic||||minutes||Full Range|Median
2585846|NCT02341144|Primary|Post Operative Pain Rating|Using the Wong-Baker FACES Pain Rating Scale (WBFPRS)- pain scores range from zero (no pain) to ten (worst pain) and the average score was reported|from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours||||units on a scale||Full Range|Mean
2585847|NCT02340962|Secondary|Change From Baseline in HCV RNA (log10 IU/mL)||Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)|Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.|||log10 IU/mL||Standard Deviation|Mean
2585899|NCT02340676|Secondary|Overall Survival|Overall survival From the start of treatment to 1 Year was assessed|From the start of treatment to 1 Year||||percentage of probability||95% Confidence Interval|Number
2585848|NCT02340962|Secondary|Proportion of Subjects With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal Limit of ALT at Final Treatment Visit.||From baseline (day 1) to the final treatment visit (week 12 or week 24)|Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.|||Participants|||Count of Participants
2585849|NCT02340962|Secondary|Proportion of Subjects Experiencing Virologic Failure During Treatment and Viral Relapse After the End of Treatment.||Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)|Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.|||Participants|||Count of Participants
2585850|NCT02340962|Secondary|Mean Absolute Values in HCV RNA (log10 IU/mL)||Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)|Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.|||log10 IU/mL||Standard Deviation|Mean
2585851|NCT02340962|Secondary|Proportion of Subjects Achieving HCV RNA < LLOQ, TND||Treatment period (12 to 24 weeks) and after the end of treatment (12 to 24 weeks)|Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs. Missing data were excluded in the dominator of on-treatment visits, while imputation was performed at post-treatment visits and the dominator for post-treatment visits was the total population.|||Participants|||Count of Participants
2585852|NCT02340962|Secondary|Proportion of Subjects Achieving HCV RNA < Lower Limit of Quantification, Target Detected or Target Not Detected (< LLOQ, TD or TND)||The whole treatment period, 12 to 24 weeks|Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs. Missing data were excluded in the dominator of on-treatment visits.|||Participants|||Count of Participants
2585853|NCT02340962|Secondary|Proportion of Subjects Achieving Sustained Viral Response at 4, 8, and 24 Weeks After the End of Treatment (SVR4, SVR8, and SVR24)||4, 8, 24 weeks after the end of treatment (SVR4, 8, 24), after 12 to 24 weeks treatments|Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.|||Participants|||Count of Participants
2585854|NCT02340962|Primary|Antiviral Efficacy is Measured by the Proportion of Subjects With HCV RNA< LLOQ (Lower Limit of Quantification), TD (Target Detected) or TND (Target Not Detected) at 12 Weeks After the End of Treatment.|Antiviral efficacy is measured by the proportion of subjects with HCV RNA< LLOQ (lower limit of quantification), TD (target detected) or TND (target not detected) at 12 weeks after the end of treatment (SVR12) in the Full Analysis Set (FAS) population, which include subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.|12 weeks after the end of treatment (SVR12), after 12 to 24 weeks treatments|Full Analysis Set (FAS) population includes subjects with genotype 1b HCV infection who were enrolled and received at least one dose of study drugs.|||Participants|||Count of Participants
2585855|NCT02340819|Secondary|Apparent Volume of Distribution (Vz/F) of Teduglutide in Plasma|Apparent volume of distribution of teduglutide in plasma were evaluated.|Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose|PK analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data were considered sufficient and interpretable.|||liter||Standard Deviation|Mean
2585856|NCT02340819|Secondary|Apparent Clearance (CL/F) of Teduglutide in Plasma|Apparent clearance of teduglutide in plasma were evaluated.|Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose|PK analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data are considered sufficient and interpretable.|||liter per hour (L/h)||Standard Deviation|Mean
2585857|NCT02340819|Secondary|Terminal Half-Life (t1/2) of Teduglutide in Plasma|Terminal half-life of teduglutide in plasma were evaluated.|Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose|PK analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data were considered sufficient and interpretable.|||hour||Full Range|Median
2585858|NCT02340819|Secondary|Time to Reach Maximum Observed Drug Concentration (Tmax) of Teduglutide in Plasma|Time to reach maximum observed drug concentration of teduglutide in plasma was evaluated.|Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose|PK analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data were considered sufficient and interpretable.|||hour||Full Range|Median
2585859|NCT02340819|Secondary|Maximum Concentration (Cmax) of Teduglutide in Plasma|Maximum concentration of teduglutide in plasma were evaluated.|Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose|PK analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data were considered sufficient and interpretable.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2585860|NCT02340819|Secondary|Area Under the Concentration-Time Curve From Time Zero to the Last Time Point (AUC0-t) of Teduglutide in Plasma|Area under the concentration-time curve from time zero to the last time point of teduglutide in plasma were evaluated.|Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose|PK analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data were considered sufficient and interpretable.|||ng*h/mL||Standard Deviation|Mean
2585861|NCT02340819|Secondary|Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-Inf) of Teduglutide in Plasma|Area under the concentration-time curve from time zero to infinity of teduglutide in plasma were evaluated.|Pre-dose, 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dose|Pharmacokinetic (PK) analysis population was defined as all participants, at Stage 2, in the safety analysis population for whom the primary PK data were considered sufficient and interpretable.|||Nanogram*hour per milliliter (ng*h/mL)||Standard Deviation|Mean
2585862|NCT02340819|Primary|Stage 4: Percent Change From Baseline in Plasma Citrulline Levels at End of Treatment|Plasma citrulline was measured as an assessment of enterocyte mass. Percent change in plasma citrulline from baseline at end of treatment was reported.|Baseline (stage 4), End of Treatment (up to 47 months)|ITT population consisted of all participants who were enrolled and eligible to enter Stage 2.|||Percent change||Standard Deviation|Mean
2605725|NCT02107014|Primary|Change in IFN-β From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2585863|NCT02340819|Primary|Stage 4: Absolute Change From Baseline in Plasma Citrulline Levels at End of Treatment|Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at end of treatment was reported.|Baseline (stage 4), End of Treatment (up to 47 months)|ITT population consisted of all participants who were enrolled and eligible to enter Stage 2.|||Micromoles per liter||Standard Deviation|Mean
2585864|NCT02340819|Primary|Stage 4: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at End of Treatment|Absolute change from baseline in number of days per week of PS usage at end of treatment was reported.|Baseline (stage 4), End of Treatment (up to 47 months)|ITT population consists of all participants who were enrolled and eligible to enter Stage 2.|||days/week||Standard Deviation|Mean
2585865|NCT02340819|Primary|Stage 4: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment|Percent change from baseline in weekly PS volume at end of treatment was reported.|Baseline (stage 4), End of Treatment (up to 47 months)|ITT population consisted of all participants who were enrolled and eligible to enter Stage 2.|||Percent change in PS volume||Standard Deviation|Mean
2585866|NCT02340819|Primary|Stage 4: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment|Absolute change from baseline in weekly PS volume at end of treatment was reported.|Baseline (stage 4), End of Treatment (up to 47 months)|ITT population consisted of all participants who were enrolled and eligible to enter Stage 2.|||L/week||Standard Deviation|Mean
2585867|NCT02340819|Primary|Stage 3: Percent Change From Baseline in Plasma Citrulline Levels at Extension Month 24|Plasma citrulline was measured as an assessment of enterocyte mass. Percent change from baseline in plasma citrulline at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.|Baseline (stage 3), Extension Month 24|ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
2585868|NCT02340819|Primary|Stage 3: Absolute Change From Baseline in Plasma Citrulline Levels at Extension Month 24|Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.|Baseline (stage 3), Extension Month 24|ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Micromoles per liter||Standard Deviation|Mean
2585869|NCT02340819|Primary|Stage 3: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Extension Month 24|Absolute change from baseline in number of days per Week of PS usage at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.|Baseline (stage 3), Extension Month 24|ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||days/week||Standard Deviation|Mean
2585870|NCT02340819|Primary|Stage 3: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24|Percent change from baseline in weekly PS volume at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.|Baseline (stage 3), Extension Month 24|ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Percent change in PS volume||Standard Deviation|Mean
2585871|NCT02340819|Primary|Stage 3: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Extension Month 24|Absolute change from baseline in weekly PS volume at extension Month 24 was reported. Extension month 24 = 30 months of teduglutide treatment.|Baseline (stage 3), Extension Month 24|ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||L/week||Standard Deviation|Mean
2585872|NCT02340819|Primary|Stage 2: Number of Participants Who Achieved Enteral Autonomy at Week 24|Enteral autonomy was defined as no prescribed PS and no use of PS recorded in the participant diary at the end of stage 2. Number of participants who achieved enteral autonomy at Week 24 was reported.|Week 24|ITT population consisted of all participants who were enrolled and eligible to enter Stage 2.|||Participants|||Count of Participants
2585873|NCT02340819|Primary|Stage 2: Percent Change From Baseline in Plasma Citrulline Levels at Week 24|Plasma citrulline was measured as an assessment of enterocyte mass. Percent change from baseline in plasma citrulline at Week 24 was reported.|Baseline (stage 2), Week 24|ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
2585874|NCT02340819|Primary|Stage 2: Absolute Change From Baseline in Plasma Citrulline Levels at Week 24|Plasma citrulline was measured as an assessment of enterocyte mass. Absolute change from baseline in plasma citrulline levels at Week 24 was reported.|Baseline (stage 2), Week 24|ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Micromoles per liter||Standard Deviation|Mean
2585875|NCT02340819|Primary|Stage 2: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Week 24|Absolute change from baseline in number of days per Week of PS usage at Week 24 was reported.|Baseline (stage 2), Week 24|ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Days per week (days/week)||Standard Deviation|Mean
2585876|NCT02340819|Primary|Stage 2: Percentage of Participants Who Demonstrate Response to Teduglutide at End of Stage 2|Response was defined as the achievement of at least a 20% reduction from baseline (Visit 2) in weekly PS volume at Week 20 and again at Week 24.|End of Stage 2 (up to Week 24)|ITT population consisted of all participants who were enrolled and eligible to enter Stage 2.|||Percentage of Participants|||Number
2585877|NCT02340819|Primary|Stage 2: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24|Percent change from baseline in weekly PS volume at Week 24 was reported.|Baseline (stage 2), Week 24|ITT population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Percent change in PS volume||Standard Deviation|Mean
2585878|NCT02340819|Primary|Stage 2: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24|Absolute change from baseline in weekly PS volume at Week 24 was reported.|Baseline (stage 2), Week 24|Intent-to-treat (ITT) population consisted of all participants who were enrolled and eligible to enter Stage 2. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||Liter per week (L/week)||Standard Deviation|Mean
2585879|NCT02340806|Other Pre-specified|Patient Satisfaction of Labor Anesthesia|Patient satisfaction of labor anesthesia using a score of 0 low satisfaction to 100 high satisfaction on a 100 millimeter scale.|Up to 24 hours after delivery of baby||||score on a scale (0 poor 100 good)||Inter-Quartile Range|Median
2585880|NCT02340806|Other Pre-specified|Number of Participants With Epidural Re-doses|Total number of patients requiring epidural re-doses given by the provider.|epidural placement to delivery, up to 36 hours.||||Participants|||Count of Participants
2585881|NCT02340806|Other Pre-specified|Stage of Labor at Re-dose Request|The stage of labor ( first or second) at the time of re-dose request.|Through 2 stages of labor up to 24 hours||||Participants|||Count of Participants
2585882|NCT02340806|Other Pre-specified|Mean Pain Score|Weighted mean pain score (measured by the area under the VAS (Visual Analog Scale)-time curve calculated using the trapezoidal integration divided by the duration of labor analgesia).Visual Analog Scale is a 100 millimeter scale where 0 is no pain and 100 is worst pain imaginable.|epidural placement to delivery, up to 36 hours.||||units on a scale||Inter-Quartile Range|Mean
2585883|NCT02340806|Other Pre-specified|Time to Provider Administered Supplemental Boluses|Time to provider administered supplemental boluses measured in minutes|epidural to first request of redose up to 10 hours||||Minutes||Inter-Quartile Range|Median
2585884|NCT02340806|Secondary|Satisfaction Scores|Patients overall satisfaction with pain management. The scale 0= poor satisfaction and 100= good satisfaction with pain management.|up to 24 hours after delivery||||score on a scale (0 poor 100 good)||Inter-Quartile Range|Median
2585885|NCT02340806|Secondary|Ratio of Total Number of PCEA Boluses Requested and Delivered|The ratio of the total number of PCEA (Patient Controlled Epidural Anesthesia) bolus's requested and PCEA doses delivered.|epidural placement to delivery, up to 36 hours.||||Ratio||Inter-Quartile Range|Median
2585886|NCT02340806|Secondary|Total Number of Delivered PCEA Boluses|Total number of PCEA (Patient Controlled Epidural Anesthesia) bolus's delivered.|epidural placement to delivery, up to 36 hours.||||Doses||Inter-Quartile Range|Median
2585887|NCT02340806|Secondary|Total Number of Requested PCEA Boluses|Number of PCEA (Patient Controlled Epidural Anesthesia) bolus doses delivered|epidural placement to delivery, up to 36 hours.||||Doses||Inter-Quartile Range|Median
2585888|NCT02340806|Secondary|Total Bupivacaine Consumption Per Hour of Labor Analgesia|Total bupivacaine amount (milligrams/hour mg/h) via pump and provider administered supplemental boluses|epidural placement to delivery, up to 36 hours.||||milligrams per hour||Inter-Quartile Range|Median
2585889|NCT02340806|Primary|Number of Participants Who Experienced Breakthrough Pain.|Number of participants who experienced breakthrough pain requiring a provider administered bolus by the anesthesia providers.|epidural placement to delivery, up to 36 hours.||||Participants|||Count of Participants
2585890|NCT02340780|Secondary|Progression Free Survival|Progression-free survival (PFS) is defined as the time in months from study entry until disease progression or death.|30 months|All eligible patients who received protocol treatment|||months||95% Confidence Interval|Median
2585891|NCT02340780|Primary|Overall Response Rate|"To determine the overall response rate (complete + partial response, as defined in the protocol) to oral buparlisib in patients with relapsed and refractory chronic lymphocytic leukemia.~Complete Response (CR): CR requires all of the criteria listed on page 31 of the protocol, maintained for a period of at least 8 weeks.~Partial Response (PR): To define a PR, at least 1 of the criteria of Group A plus 1 of the criteria of Group B listed on page 32 of the protocol must be met and persist for ≥ 8 weeks, in the absence of any criteria definitive of progressive disease."|30 months|All eligible patients who received the protocol treatment.|||Participants|||Count of Participants
2585892|NCT02340767|Secondary|Number of Clinicians in Likelihood of Surgically Treating Lesions in Online Vignettes That Display Two Levels of Four Cues (Color, Surface Smoothness, Surface Luster, and Caries Risk) in Pre-intervention|Clinicians' likelihood of treating surgical lesions depicted with brown verses black, smooth verses rough, shiny verses matte, in patients with high verses low caries risk, by post-intervention phases. The outcome measure will be to see what cues were used or treatment decisions in the pre-intervention phase. Please note that more than one cue could be chosen, so values may add to more than 100 percent of participants.|Pre-intervention (dentists completed the vignettes one time)|Pre-intervention the dentists were not randomized and had no device training and all dentists were combined|||Participants|||Count of Participants
2585893|NCT02340767|Secondary|Number of Clinicians in Likelihood of Surgically Treating Lesions in Online Vignettes That Display Two Levels of Five Cues (Color, Surface Smoothness, Surface Luster, Caries Risk, and Device Reading (if Applicable) in Post-intervention|Clinicians' likelihood of treating surgical lesions depicted with brown verses black, smooth verses rough, shiny verses matte, in patients with high verses low caries risk, by post-intervention phases. The outcome measure will be to see what cues were used or treatment decisions in the post-intervention phase. Please note that more than one cue could be chosen, so values may add up to more than 100 percent. Participants in the no device group did not receive a device reading cue.|Post-intervention (dentists completed the vignettes one time)||||Participants|||Count of Participants
2585894|NCT02340767|Primary|Number of Lesions That Received Invasive Treatment and the Number of Lesions Receiving Invasive Treatment That Extended Into Dentin|There was one lesion/patient.|Pre-intervention and post-intervention (one day visit)|Only the patients who received invasive treatment were analyzed for extension into dentin.Not all columns add up to the total N due to missing values.|||lesions|||Number
2585895|NCT02340715|Primary|Number of Participants Successfully Contributing MRI Data|We tested these Advanced MR protocols to evaluate which ones would best visualize the target region. This helped us determine the optimum MR SIM protocols for different sites that became clinical standard.|up to 4 weeks from imaging||||Participants|||Count of Participants
2585896|NCT02340676|Secondary|Relapse at 1 Year|Relapse at 1 year was assessed|From the start of treatment to 1 Year||||percentage of probability||95% Confidence Interval|Number
2585900|NCT02340676|Secondary|Prednisone Use During ECP Plus Low-dose IL-2 From Baseline Through Week 16 of Study|Prednisone use was assessed during ECP plus low-dose IL-2 treatment at baseline through Week 16 of study.|Baseline through Week 16 of the study||||median percentage of change||Full Range|Median
2585901|NCT02340676|Secondary|Regulatory T Cell Counts During ECP Plus Low-dose Daily SC IL-2|Assays will be conducted to detect Change in Regulatory T cell counts during ECP plus low-dose daily SC IL-2|Baseline through Week 16 of the study||||cells/uL||Inter-Quartile Range|Median
2585902|NCT02340676|Secondary|Number of Grade 3 or Higher Toxicities Related to ECP Plus Low-dose SC IL-2 Therapy|All Grade 3 or higher toxicities related to ECP plus low-dose SC IL-2 therapy have been reported.|Baseline through Week 16 of the study||||Occurrance of reported grade|||Number
2585903|NCT02340676|Primary|Percentage of Participant With Response at Week 16|Participants will have their cGVHD evaluated at baseline through Week 16.|Baseline through Week 16 of the study|22 evaluable for efficacy|||percentage of patients||90% Confidence Interval|Number
2585904|NCT02340663|Secondary|Stability -- Number of Splints Dislodged During Maximum Openings|Count of the number of participants whose individual splints were dislodged at least once when participants opened as wide as possible and then closed. The task was repeated five times. Counts are partitioned into the number dislodged < 1 mm, number dislodged between 1 - 2 mm, number dislodged between 2 - 3 mm, number dislodged between 3 - 4 mm and number dislodged between 4 - 5 mm.|4 Months|Data not available for one participant in the Michigan bite splint group.|||Participants|||Count of Participants
2585905|NCT02340663|Secondary|Stability -- Number of Splints Dislodged by Tapping|Count of the number of participants whose individual splints were dislodged at least once when participants tapped their teeth on the splint 5 times. Counts are partitioned into the number dislodged < 1 mm, and those dislodged between 1 - 2 mm.|4 months|Data not available from one participant in the Michigan bite splint group.|||Participants|||Count of Participants
2585906|NCT02340663|Secondary|Stability -- Number of Splints Dislodged During Border Movement Trials|Count of the number of participants whose individual splints were dislodged at least once when participants performed grinding-like movements of the teeth against the splint in extreme positions. These extreme movements and positions were performed 5 times. Counts are partitioned into those dislodged > 1 mm, those dislodged between 1 - 2 mm, those dislodged 2 - 3 mm, those dislodged 3 - 4 mm, those dislodged 4 - 5 mm, those dislodged 5 - 6 mm and those dislodged > 6 mm.|4 months|Data not available for one participant in the Michigan bite splint group.|||Participants|||Count of Participants
2585907|NCT02340663|Secondary|Stability -- Number of Splints Dislodged by Grinding|Count of the number of participants whose individual splints were dislodged at least once when participants ground their teeth against the splint to the left (5 times), to the right (5 times, and front to back (5 times). Count is partitioned into those dislodged by < 1 mm, between 1 - 2 mm, between 2 - 3 mm, between 3 - 4 mm, and > 6 mm. Categories between 4 and 6 mm are not included, as no splints fell into this range.|4 Months|Data not available for one participant in the Michigan bite splint group.|||Participants|||Count of Participants
2585908|NCT02340663|Secondary|Stability -- Number of Splints Dislodged by Clenching|Count of the number of participants whose individual splints were dislodged at least once when participants clenched their teeth against the splint five times. Numbers are sorted into those that moved < 1 mm, those that moved between 1 - 2 mm, those that moved between 2 - 3 mm and those that moved > 6 mm during the performance of five repeats of clenching. Categories from 3 mm to 6 mm are not included, because no splints fell into this range of values.|4 months|Data not available for one participant in the Michigan bite splint group|||Participants|||Count of Participants
2585909|NCT02340663|Secondary|Stability -- Splint Movement During Jaw Movement Tasks|Movement of each subject's splint on the teeth, due to rocking or dislodgement, measured in millimeters during five repetitions of the following five tasks: clenching, grinding, moving jaw to extreme positions on the splint, tapping, opening maximally. For control, movements of the splint while the jaw was in a rest position (teeth apart, jaw relaxed) were also measured. The maximum movement during the five repetitions of each task was calculated for each subject and used in statistical analyses.|4 months|Data not available for one participant in the Michigan bite splint treatment group.|||millimeters||Standard Deviation|Mean
2585910|NCT02340663|Secondary|Fabrication Efficacy -- Oral Health Modified Gingival Index|Gums or gingiva around each tooth is quantified for absence of inflammation (0), mild inflammation around part of the gingiva next to the tooth (1), mild inflammation involving all of the gingiva next to the tooth (2), moderate inflammation (3), or severe inflammation (4). Average scores are created for the cheek side of the upper teeth (Buccal Upper), palate side of upper teeth (Lingual Upper), cheek side of lower teeth (Buccal Lower) and tongue side of lower teeth (Lingual Lower). Mean and standard deviation scores for each of these regions and for week 1 and month 4 are shown as descriptive statistics; statistical results for the between-subject effects are reported. Overall means for each treatment group (SOVA and Michigan splints) are also reported.|1 week and 4 months||||Units on a scale||Standard Deviation|Mean
2585911|NCT02340663|Secondary|Fabrication Efficacy -- Oral Health Plaque Index|The Rustogi et al. Modification of the Navy Plaque Index method of scoring plaque was used. This involves dividing the cheek-facing (Buccal) and the tongue/palate-facing (Lingual) surfaces of each tooth into 9 regions and scoring whether disclosed plaque is present (1) or absent (0) in each of these 9 regions. The total number of regions with plaque was then tabulated as the proportion of total regions for four mouth areas, viz., the cheek sides of the upper teeth (Buccal Upper), the cheek sides of the lower teeth (Buccal Lower), the palate sides of the upper teeth (Lingual Upper) and the tongue sides of the lower teeth (Lingual Lower). Overall means for each treatment group (SOVA and Michigan splints) are also reported.|1 week and 4 months||||proportion of total regions||Standard Deviation|Mean
2585912|NCT02340663|Secondary|Fabrication Efficacy -- Tissue Adaptation, Tightness. Number of Participants Reporting Excessive Tightness|Splints were evaluated for sensation of tightness on the teeth. SOVA splints that were said to be too tight by the participants and that subsequently required intervention by the attending dentist to fix were graded as 1 (poor adaptation); Michigan splints that were said to be too tight by the participants and that required the attending dentist to spend > 15 minutes of the delivery appointment to fix were graded as 1 (poor adaptation); all splints not meeting these criteria were scored as 0 (good adaptation). Total participants in each group with poorly adapted splints is reported.|Day of Delivery||||Participants|||Count of Participants
2585913|NCT02340663|Secondary|Fabrication Efficacy -- Tissue Adaptation, Number of Subjects Whose Splints Had Excessive Material|Splint rims were evaluated for thickness. Splints requiring modification by the attending dentist to remove excess material were graded as 1 (poor adaptation); splints that did not require removal of excess material were graded as 0 (good adaptation). Number of participants in each group whose splint manifest poor adaptation is reported.|Day of Delivery||||Participants|||Count of Participants
2585914|NCT02340663|Secondary|Fabrication Efficacy -- Tissue Adaptation, Facial Rim. Number of Participants With Poor Adaptation|Lip- and cheek-sides of splints were evaluated for contact with the premolar and molar teeth. Splints lacking contact (> 1 mm space between splint and teeth) were graded as 1 (poor adaptation); splints with < 1 mm space between splint and teeth, from molar to molar as 0 (good adaptation). Inter-proximal contacts Number of total participants with splints in each group with poor adaptation is reported.|Day of Delivery||||Participants|||Count of Participants
2585915|NCT02340663|Secondary|Fabrication Efficacy -- Tissue Adaptation, Palatal Rim. Number of Participants With Poor Adaptation|Palate-side of splints was evaluated for contact with the palate. Splints that were > 1 mm from contact with palate, from molar to molar were graded as 1 (poor adaptation); splints in continuous contact or lacking contact < 1mm with palate, from molar to molar were graded as 0 (good adaptation). Number of participants with splints in each group with poor adaptation is reported.|Day of delivery||||Participants|||Count of Participants
2585916|NCT02340663|Secondary|Fabrication Efficacy -- Retention Trials, Month 4|Number of times splint was dislodged while performing eight different movements, with each movement being performed five times (maximum number therefore = 40). Dislodgement meant that, after performing the movement, the splint either fell off the teeth completely or that biting down on the splint resulted in its being reseated on the teeth.|4 months|Data not available for one SOVA participant.|||Number of occurrences out of 40.||Standard Deviation|Mean
2585917|NCT02340663|Secondary|Fabrication Efficacy -- Retention Trials Week 1|Number of times splint was dislodged while performing eight different movements, with each movement being performed five times (maximum number therefore = 40). Dislodgement meant that, after performing the movement, the splint either fell off the teeth completely or that biting down on the splint resulted in its being reseated on the teeth.|1 week|Data not available for one SOVA participant.|||Occurrences||Standard Deviation|Mean
2585918|NCT02340663|Secondary|Fabrication Efficacy -- Estimated Bite Forces During Stability Testing|Estimated bite forces in kilograms associated with performing each of the following tasks: moving the jaw in extreme positions with pressure against the splint (Border), clenching (Clench), grinding side to side (Grind Lateral), grinding front to back (Grind Protrusive), tapping hard on splint (Tap). Overall means for each treatment group (SOVA and Michigan splints) are also reported.|4 months||||kilograms||Standard Deviation|Mean
2585919|NCT02340663|Secondary|User Satisfaction -- Self-Report of Splint Fit|"Responses to the question, The splint fits well with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out during the final appointment."|4 months||||Units on a scale||Standard Deviation|Mean
2585920|NCT02340663|Secondary|User Satisfaction -- Ease of Instructions|"Responses to the question, The instructions were easy to follow with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out at the end of the appointment during which time the splints were made by participants."|On day of delivery|One SOVA bite splint participant did not respond to this question. Michigan bite splint participants did not fabricate their splints; hence, this question was irrelevant for them.|||Participants|||Count of Participants
2585921|NCT02340663|Secondary|User Satisfaction -- Ease of Fabrication|"Responses to the question, The splint was easy to fabricate with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out at the end of the appointment during which time the splints were made by participants."|On day of delivery|One SOVA bite splint participant did not respond. Participants with the Michigan bite splint did not fabricate their splints; hence, this question is irrelevant to them.|||Participants|||Count of Participants
2585922|NCT02340663|Secondary|Functional Efficacy -- Alteration of Bruxism Habit, Self-Report of Muscle Relaxation|"Responses to the question, The splint relaxes my jaw muscles. with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out at the end of 4 months of splint wear."|4 months||||Units on a scale||Standard Deviation|Mean
2585923|NCT02340663|Secondary|Functional Efficacy -- Alteration of Bruxism Habit, Self Report of Reduced Bruxism|"Responses to the question, The splint helps my bruxism. with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out at the end of 4 months of splint wear."|4 months|Question not answered by one SOVA participant.|||Units on a scale||Standard Deviation|Mean
2585924|NCT02340663|Secondary|Functional Efficacy -- Tooth Wear|Tooth wear measured in millimeters. The number is negative to reflect the amount lost, e.g., -0.1 = a tenth of a millimeter lost. High-resolution, computer-scanned models of the teeth in the lower jaw on the delivery data were combined with high-resolution, computer-scanned models of the same teeth and jaw after 4 months of splint wear. Sites where teeth showed cratering due to dentin exposure were targeted to make these measurements. Changes in these areas was quantified using a computer program designed to quantify differences between two computer models. The measurement represents the difference between the two models, defined by a mean value sampled from a standard-sized area, which was set to be about the size of dentin exposure areas (~ 1 millimeter in diameter). Group means were compared with t-tests.|4 months|Mandibular models were not available for two SOVA patients.|||millimeters||Standard Deviation|Mean
2585925|NCT02340663|Secondary|Compliance -- Use of Alternative Devices|"Responses to the question, I use an additional splint with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out at the end of 4 months of splint wear."|4 months||||Units on a scale||Standard Deviation|Mean
2587117|NCT02322814|Secondary|Cohort I: Percentage of Participants With Confirmed OR (PR or CR), as Determined by the Investigator Using RECIST v1.1||Randomization up to disease progression or relapse, whichever occurs first (up to approximately 5.5 years)||2021-04-30|04/2021||||
2585926|NCT02340663|Secondary|Compliance -- Appliance Removal at Night|"Responses to the question, I frequently remove the splint during the night with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out at the end of 4 months of splint wear."|4 months||||Units on a scale||Standard Deviation|Mean
2585927|NCT02340663|Secondary|Splint Material Loss / 4 Months.|Splint wear measured in millimeters. The number is negative to reflect the amount lost, e.g., -0.1 = a tenth of a millimeter lost. High-resolution, computer-scanned models of the splint on the delivery date were combined with high-resolution, computer-scanned models of the same splint after 4 months of wear. Sites where teeth contacted the splints were identified, and material loss in these areas was quantified using a computer program designed to quantify differences between two computer models. The measurement represents the difference between the two models, defined by a mean value sampled from a standard-sized area, which was set to be about the size of a tooth cusp (~ 3 millimeters in diameter). Group means were compared with t-tests.|4 months|Three SOVA subjects and 1 Michigan subject were not included in the analysis, because the scanned models could not be successfully aligned. This was likely due to a warpage of the impressions taken, warpage in the stone models that were scanned, or error in the model scanning process.|||millimeters||Standard Deviation|Mean
2585928|NCT02340663|Secondary|Number of Bruxing Events Per Hour Sleep Per Night.|Polysomnographic monitors were used to evaluate masticatory muscle activity during sleep. Activity of jaw closing muscles found in the cheeks (masseter muscles) occur in bursts, where a burst is taken as evidence for a jaw clench. The total number of bursts recorded during the night was tabulated and then divided by the total hours of sleep. Means presented are based on data gathered on night 122 (4 months of splint wear) and compared with ANOVA.|4 months|Polysomnographic data were not available from 5 SOVA and 3 Michigan splint subjects due to data corruption. Corruption typically occurs when a subject either removes the device or an electrode while sleeping, or the recorded data are too noisy to analyze due to electronic interference while the subject is asleep.|||muscle bursts / hour||Standard Deviation|Mean
2585929|NCT02340663|Primary|Total Number of Nights of Splint Wear for Four Months Per Subject.|Count of the total number of entire nights that subjects wore the splint provided to them in the study.|4 months||||nights||Standard Deviation|Mean
2585930|NCT02340520|Secondary|Change in HDAC2 Levels|circulating Histone Deacetylase2 levels measured in blood sample|Baseline, Week 1 and 2||||µM/µg||Standard Error|Mean
2585931|NCT02340520|Primary|Bronchodilation|Change in FEV1 L and FVC L|Baseline, Week 1 and 2||||liters||Standard Deviation|Mean
2585932|NCT02340338|Secondary|Number of Participants With Seroconversion|ELISA IgG against rTSST-1|through day 70||||participants|||Number
2585933|NCT02340338|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Clinical observations and clinical laboratory values|through day 70||||participants with any solicited AE|||Number
2585934|NCT02340221|Secondary|Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score|EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores were averaged and transformed to a 0-100 scale. Higher scores for the functional scales indicated a higher/better level of functioning/healthy functioning. Higher scores for the symptom scales indicated worse symptoms.|Baseline, C2D1 up to C7D1 (each cycle=28 days)|Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment. Data are reported for evaluable participants.|||score on a scale||Standard Deviation|Mean
2585935|NCT02340221|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score|"The EORTC QLQ-C30 consists of 30 questions that comprise aspects of participant's functioning assessment (physical, emotional, role, cognitive, and social); symptom scales (fatigue; nausea, vomiting, and pain; the global health/quality of life [QoL]); and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties), within a recall period of the past week. Most questions used a 4-point scale (1=Not at all to 4=Very much; two questions used a 7-point scale (1=Very poor to 7=Excellent). Scores were averaged and transformed to a 0-100 scale; a higher score for Global Qol/functional scales=better level of functioning; a higher score for symptom scale=greater degree of symptoms."|Baseline, C2D1 up to C7D1 (each cycle=28 days)|Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment. Data are reported for evaluable participants.|||score on a scale||Standard Deviation|Mean
2585936|NCT02340221|Secondary|Minimum Observed Plasma Concentration (Cmin) of Taselisib||1 to 4 hrs post-dose on Cycle 1, Day 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1; 0 to 3 hrs pre-dose on Cycle 6, Day 1 (each cycle=28 days)|The PK population included all participants who received at least one dose of taselisib and provided valid (adequately documented dose time and PK sample time) PK assessments.|||ng/mL||Standard Deviation|Mean
2585937|NCT02340221|Secondary|Maximum Observed Plasma Concentration (Cmax) of Taselisib||1 to 4 hours (hrs) post-dose on Cycle (C) 1, Day (D) 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1 (each cycle=28 days)|The Pharmacokinetic (PK) population included all participants who received at least one dose of taselisib and provided valid (adequately documented dose time and PK sample time) PK assessments.|||ng/mL||Standard Deviation|Mean
2585938|NCT02340221|Secondary|Percentage of Participants With Adverse Events|An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.|From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years.|The safety-evaluable population included all randomized participants who received at least one dose of taselisib or placebo or fulvestrant.|||percentage of participants|||Number
2585947|NCT02340078|Primary|Proportion of the Subjects With at Least 10mm Difference in VAS Pain Scale Scores Within the Subject (VAS of the Control Device - VAS of the Test Device) Immediately After Treatment With the Investigational Devices|The degree of pain was evaluated by VAS (Visual Analog Scale), measuring the length from the left and to the mark by the subject in millimeter (mm) unit.|Visit 2 (week 0, immediately after treatment)||||participants|||Number
2585939|NCT02340221|Secondary|PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1|PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.|From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)|Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.|||months||95% Confidence Interval|Median
2585940|NCT02340221|Secondary|Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1|Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.|Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)|Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment. Data are reported for participants with responses.|||months||95% Confidence Interval|Median
2585941|NCT02340221|Secondary|Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1|Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.|From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)|Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.|||percentage of participants||95% Confidence Interval|Number
2585942|NCT02340221|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death due to any cause.|From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)|Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.|||months||95% Confidence Interval|Median
2585943|NCT02340221|Secondary|Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1|PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).|From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)|Randomized participants with PIK3CA-mutant tumors and measurable disease at baseline, regardless of whether they received any amount of study treatment.|||percentage of participants||95% Confidence Interval|Number
2585944|NCT02340221|Primary|Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)|PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.|From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)|Randomized participants with PIK3CA-mutant tumors, regardless of whether they received any amount of study treatment.|||months||95% Confidence Interval|Median
2585945|NCT02340104|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib Following Both the Oral and the IV Dose|AUC[0-∞] is is the area under the concentration verses time curve from zero to infinity, reported as nanograms times hour per milliliter (ng*h/mL).|Predose, 0.5, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 Hours Postdose|All participants who received at least 1 dose of study drug.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2585946|NCT02340091|Primary|Proportion of the Subjects With at Least 10mm Difference in VAS Pain Scale Scores Within the Subject (VAS of the Control Medical Device - VAS of the Test Medical Device) Immediately After Treatment With the Investigational Medical Devices|The degree of pain was evaluated by VAS (Visual Analog Scale), measuring the length from the left and to the mark by the subject in millimeter (mm) unit.|Visit 2 (week 0, immediately after treatment)||||participants|||Number
2585948|NCT02340000|Secondary|Willingness to Take the Study Antibiotic in the Future|whether participants said they would NOT take the antibiotic again|end of 10th day||||Participants|||Count of Participants
2585949|NCT02340000|Secondary|Nasal Colonization With Resistant Bacteria|Clinicians performed anterior nasal cultures to look for colonization with penicillin-resistant pneumococci and other pathogens (stopped after participant #231 because of lack of funds).|baseline|All 231 participants were analyzed together regardless of treatment.|||Participants|||Count of Participants
2585950|NCT02340000|Secondary|SNOT-16 - Day 10|"Ratings on a scale from 0=none to 3=severe of 16 sinusitis-related symptoms. Total score can range from 0 to 48 (with 48 the most severe possible) of the 16 symptoms.~The outcome measure was the mean difference in the ratings of each of the 16 symptoms between day 0 and day 10 (values at day 0 minus values at day 10)."|day 0, end of 10th day|The number of participants who gave ratings at day 10.|||units on a scale||Standard Deviation|Mean
2585951|NCT02340000|Secondary|Subjective Improvement - Day 10|"rating of a lot better or no symptoms"|end of 10th day|The number of participants who gave a rating at day 10.|||Participants|||Count of Participants
2585952|NCT02340000|Secondary|SNOT-16 - Day 3|"Ratings on a scale from 0=none to 3=severe of 16 sinusitis-related symptoms. Total score can range from 0 to 48 (with 48 the most severe possible) of the 16 symptoms.~The outcome measure was the mean difference in the ratings of each of the 16 symptoms between day 0 and day 3 (values at day 0 minus values at day 3)."|day 0, end of 3 days of treatment|The number of participants who gave ratings at day 3.|||units on a scale||Standard Deviation|Mean
2585953|NCT02340000|Primary|"Subjective Improvement - Day 3 (Rating of a Lot Better or no Symptoms)"|"rating of a lot better or no symptoms"|end of 3 days of treatment|The number of participants who gave ratings at the end of day 3 of treatment|||Participants|||Count of Participants
2585954|NCT02339909|Secondary|Number of Patients Requiring Intervention After Sight Outcome From Diabetic Retinopathy Screening.|The outcome measure from screening is an ordinal measure indicating whether there is no retinopathy, or varying degrees of retinopathy. This will be measured at the screening appointment (for those participants who attend their appointment). We report whether there is further management required as a result of screening.|Number of patients with additional management triggered as a result of test at designated screening appointment (between three months and one year)|These are the numbers of each group that attended screening and had retinopathy screening|||Participants|||Count of Participants
2585955|NCT02339909|Primary|Attendance at Screening Appointment|"The participants will be invited to a specific appointment between three months and one year from their previous missed appointment. The primary outcome refers to the number of participants who did attend their appointment.~(This non specific timeframe is consistent with the exceptions discussed in the guidance notes, http://prsinfo.clinicaltrials.gov/ProtocolDetailedReviewItems.pdf:~Exceptions are possible, for example, in measures that are assessed at the particular time the intervention is administered (e.g., at time of surgery).)"|At designated appointment date (between three months and one year from previous missed appointment)||||Participants|||Count of Participants
2585956|NCT02339831|Secondary|General Pain|"Self-reported total pain medication consumption was recorded by patients and at the end of the four-week period converted into standard units for comparison as oxycodone equivalent dosage."|4-6 weeks post-op||||mg||Standard Deviation|Mean
2585957|NCT02339831|Secondary|General Functional Orthopaedic Outcome Measures|Knee society score is an objective patient reported outcome survey to measure a patient's functional ability before and after knee arthroplasty. It is measured on a scale of 1-100. A score between 80-100 indicated excellent functioning, a score between 70-79 indicates good functioning, a score between 60-69 indicates fair functioning, and a score below 60 indicates poor functioning.|4-6 weeks post-op||||units on a scale||Standard Deviation|Mean
2585958|NCT02339831|Secondary|General Activity Orthopaedic Outcome Measures|Western Ontario and McMaster Universities Arthritis Index is measured on a scale of 0-68. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|4-6 weeks post-op||||units on a scale||Standard Deviation|Mean
2585959|NCT02339831|Secondary|General Mental Orthopaedic Outcome Measures|Short form 36 mental health score. The scale is measured from 0-100. 0 is the lowest or worst possible level of functioning and 100 is the highest or best possible level of functioning.|4-6 weeks post-op||||units on a scale||Standard Deviation|Mean
2585960|NCT02339831|Primary|Early Functional Outcome Knee Flexion|Knee-flexion was measured using an 8-inch goniometer.|4-6 weeks post op||||degrees||Standard Deviation|Mean
2585961|NCT02339831|Primary|Early Function Outcome Kinesthesia|Kinesthesia was measured by recording the angle of the flexed knee and documenting how close the patient was able to reproduce the angle with closed eyes. The differences were recorded in degrees using an 8-inch goniometer.|4-6 weeks post op||||degress||Standard Deviation|Mean
2585962|NCT02339831|Primary|Early Functional Outcome Proprioception|Biodex Balance Machine Score. The system consists of a multiaxial standing platform with a maximum tilt of 20 degrees. All participants were tested on level 8, and a balance index was calculated using the time and deviation (in degrees) on the platform relative to a neutral position. The normal range for adults 54-71 is 1.79 - 3.35. Lower values indicate better/greater stability.|4-6 weeks post-op||||units on a scale||Standard Deviation|Mean
2585963|NCT02339831|Primary|Early Functional Outcome by Sit to Stand Test|"Sit-to-Stand test: After one demonstration of the sit-to-stand test, standing up from a seated position without support, two tests were timed and the better value recorded. Patient was asked to sit with back against chair and told to stand up without using any support. Arms were suggested to be folded in front of chest. Time started with recorded said Go."|4-6 weeks post-op||||seconds||Standard Deviation|Mean
2585964|NCT02339831|Primary|Early Functional Outcome Strength|Quadriceps strength measurements using a hand held dynamometer|4-6 weeks post-op||||newton meter||Standard Deviation|Mean
2585965|NCT02339584|Primary|Mean Diurnal IOP Change From Baseline at Month 3|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Diurnal IOP was defined as the average of the three timepoints measured: 9 AM, +2 Hrs and +7Hrs. Baseline was the average of the values for 2 eligibility visits. If one of the values was missing, the other non-missing value was taken as the baseline. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement, ie, a reduction of IOP. Only one eye (study eye) contributed to the analysis.|Baseline (Day 0), Month 3|Per Protocol Analysis Set. Missing Month 3 data were imputed using a last observation carried forward method (LOCF).|||mmHg||Standard Error|Mean
2585967|NCT02339558|Other Pre-specified|Expression of PD-1 in CD8+ T Cells in TIL|The Chi-Square (or Fisher's Exact test) will be used to assess the association of categorical clinical data with categorical biomarker data. Time-to-event clinical data (PFS, OS) will be correlated with biomarker data using Kaplan-Meier methodology and Cox regression models. Logistic regression models will also be used to predict binary clinical data with baseline biomarker data. Finally, graphical methods and descriptive statistics will be used to summarize the data as well.|Baseline|||||||
2585968|NCT02339558|Other Pre-specified|Change in Serum Absolute Lymphocyte Count|The Chi-Square (or Fisher's Exact test) will be used to assess the association of categorical clinical data with categorical biomarker data. Time-to-event clinical data (PFS, OS) will be correlated with biomarker data using Kaplan-Meier methodology and Cox regression models. Logistic regression models will also be used to predict binary clinical data with baseline biomarker data. Finally, graphical methods and descriptive statistics will be used to summarize the data as well.|Baseline and up to 3 years|||||||
2585969|NCT02339558|Other Pre-specified|Intratumoral Expression of PD-1 and PD-L1|PD-1 and PD-L1 expression will be associated with treatment outcomes. The Chi-Square (or Fisher's Exact test) will be used to assess the association of categorical clinical data with categorical biomarker data. Time-to-event clinical data (PFS, OS) will be correlated with biomarker data using Kaplan-Meier methodology and Cox regression models. Logistic regression models will also be used to predict binary clinical data with baseline biomarker data. Finally, graphical methods and descriptive statistics will be used to summarize the data as well.|Baseline|||||||
2585970|NCT02339558|Other Pre-specified|Clearance of EBV DNA|Plasma EBV DNA half-life during the first 6 weeks of treatment will be correlated with RECIST-response to nivolumab.|Up to 6 weeks of treatment|||||||
2585971|NCT02339558|Secondary|Overall Survival (OS)|Overall survival is defined as the time from registration to the time of death. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause, assessed up to 3 years|One patient was ineligible for this analysis.|||months||95% Confidence Interval|Median
2585972|NCT02339558|Secondary|Progression-free Survival (PFS) Based on RECIST Version 1.1|Progression Free Survival is defined as the time from registration to the time of death or progression, whichever occurs first. The distribution of PFS will be estimated using the method of Kaplan-Meier.|Time from registration to the first of either death due to any cause or progression, assessed up to 3 years|One patient was ineligible for this endpoint due to a protocol violation.|||months||95% Confidence Interval|Median
2585973|NCT02339558|Secondary|Duration of Response|Duration of response defined as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed according to RECIST version 1.1.|Up to 3 years|All patients that reported a CR or PR on treatment were included in this analysis.|||months||95% Confidence Interval|Median
2585974|NCT02339558|Secondary|Tumor Response to Nivolumab Based on the Immune Response Criteria (IRC)|The Immune Response Criteria (IRC) is a response criteria derived from the WHO criteria.|Up to 3 years|Data was not collected to analyze this secondary endpoint.||||||
2585975|NCT02339558|Secondary|Adverse Events|Adverse events were collected and recorded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. For this outcome measure, we summarize the worst graded adverse event regardless of treatment attribution per patient. All reported adverse events are reported in the Adverse Events section of this report.|Up to 3 years on treatment|All patients that began protocol treatment are included in this analysis.|||Participants|||Count of Participants
2585976|NCT02339558|Primary|Confirmed Response Rate (Complete Response or Partial Response) Based on RECIST Version 1.1|"Confirmed response rate is defined as either a Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1. > To be consider a CR, there must be a disappearance of all target lesions and each target lymph node must have reduction in short axis to < 1.0 cm. > > To be considered a PR, at least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the baseline value. >~> The confirmed response rate is reported as the number of patients reporting a CR or PR divided by the total number of evaluable patients multiplied by 100 (reported as a percentage)."|Up to 3 years|One patient was a protocol violation and was not included in this analysis.|||percentage of patients with a response||95% Confidence Interval|Number
2585977|NCT02339545|Secondary|Major Adverse Cardiac Events (MACE)|MACE: cardiac death, acute myocardial infarction (Q wave or non-Q wave), or target vessel revascularization.|At 24 hours or at time of hospital discharge, whichever occurred first|MACE is evaluated per protocol, on subjects with successful PCI treatment of severely calcified coronary lesions|||participants|||Number
2585978|NCT02339545|Primary|Coronary Flow Reserve (CFR)|CFR was measured after successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions. It was calculated from coronary blood flow velocity measurements, which were derived from Doppler-velocity wire data recorded in real time. The CFR formula utilized was APVp/APVb, where APVb is the average peak velocity at baseline and APVp is peak hyperemia.|Intra-procedurally following successful stent placement. Average procedure time 56 minutes.|CFR is analyzed per protocol, which may require Doppler measurement in a control vessel in addition to the target vessel. Only subjects where this procedure is followed are included in the data set. The CFR formula is a ratio: APVp/APVb, where APV = average peak velocity (cm/sec). APVb = velocity at baseline and APVp = velocity at peak hyperemia.|||Ratio||Standard Deviation|Mean
2585979|NCT02339506|Other Pre-specified|Hippocampal Memory (Paired Associative Learning Task)|Hippocampal memory will be evaluated pre and post with a paired associative learning task. Face Name Associative Memory Exam (FNAME) composite score on a scale from 0-36, with 36 being the best possible score.|1 day after ACTH||||score on a scale||Standard Deviation|Mean
2585980|NCT02339506|Other Pre-specified|Pain (Quantitative Sensory Testing Using a Thermal Pain Testing Device)|Alterations in pain sensing will be evaluated pre and post with quantitative sensory testing using a thermal pain testing device, to evaluate the delayed effect of cosyntropin infusions.|1 day after ACTH||2021-04-30|04/2021||||
2586076|NCT02338492|Primary|Change in Pain|Change in VAS score from baseline. VAS is measured on a scale range from 0-100mm with 0 (no pain) to 100 (worst imaginable pain).|Baseline and 90 days|Number of subjects who had a Day 90 visit|||units on a scale||Standard Error|Least Squares Mean
2585981|NCT02339506|Primary|Cardiovagal Baroreflex Sensitivity (Modified Oxford Technique)|Cardiovagal baroreflex sensitivity will be measured with the Modified Oxford Technique before, during, and after drug infusions, to evaluate the effects of cosyntropin infusions.|Baseline, 4-hours after infusion, 24-hours after infusion||||ms/mmHg||Standard Deviation|Mean
2585982|NCT02339415|Other Pre-specified|Safety (Bleeding Events)|Number of bleeding events on Edoxaban or Placebo.|4 months while on Edoxaban or Placebo||||event|||Number
2585983|NCT02339415|Secondary|Change in D-Dimer Levels From Baseline to 4 Months|Difference between treatment and control ln-transformed D-Dimer levels in change from pre-treatment to on-treatment values|Through study completion, an average of 4 months on each treatment.|44 participants were randomized to each arm, of those, 41 went on to receive placebo and have follow up data, 40 received study drug (Edoxaban) and had follow up data.|||ln-μg/mL||Standard Deviation|Mean
2585984|NCT02339415|Primary|Change in Interleukin 6 (IL-6) Plasma Levels From Baseline to 4 Months.|Difference between treatment and control ln-transformed IL-6 plasma levels in change from pre-treatment to on-treatment values|Through study completion, an average of 4 months on each treatment.|44 participants were randomized to each arm, of those, 41 went on to receive placebo and have follow up data, 40 received study drug (Edoxaban) and had follow up data.|||ln-pg/mL||Standard Deviation|Mean
2585985|NCT02339389|Secondary|If Maternal Temperature Increases During Labor Analgesia|If maternal temperature increases during labor analgesia|4 hours||||Degree F||Standard Deviation|Mean
2585986|NCT02339389|Primary|Changes in Maternal Ventilation During Labor Analgesia|If Maternal Ventilation decreases following labor analgesia at 2 hour and 4 interval|Ventilation parameters measured at 2 hour and 4 hour||||L/min||Standard Deviation|Mean
2585987|NCT02339285|Other Pre-specified|Clinical Global Impressions (CGI) Raw Score|"This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). The investigators will compare the scores between baseline and F2.The reported values are from Item 1 Severity of Illness on a likert scale of 1 to 7, with 1=Normal, not at all ill and 7 = Among the most extremely ill patients."|Day 5; F2 (4 weeks after completion of treatment)||||units on a scale||Standard Deviation|Mean
2585988|NCT02339285|Other Pre-specified|Change in Beck Depression Inventory (BDI) Score|This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). Higher scores indicate more depressive symptoms. Total score is out of 63 possible. The investigators will compare the scores between baseline and F2. In these results, negative values indicate a decrease in depressive symptoms.|Baseline to Day 5; Baseline to F2||||units on a scale||Standard Deviation|Mean
2585989|NCT02339285|Other Pre-specified|Change in Montreal Cognitive Assessment (MoCA) Score|This measurement will be taken at baseline (first day of stimulation) and four weeks after completion of the intervention (F2). Total score ranges from 0 to 30, with higher values indicating better cognition. The investigators will compare the scores between baseline and F2. Reported values are the raw change (increase or decrease) from baseline.|Baseline to F2||||units on a scale||Standard Deviation|Mean
2585990|NCT02339285|Other Pre-specified|Change in Hamilton Depression Rating Scale (HDRS) Score|The HDRS is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome. This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). The investigators will compare the scores between baseline and F2, with negative values indicating a decrease in depressive symptoms.|Baseline to Day 5 of Stimulation; Baseline to F2||||units on a scale||Standard Deviation|Mean
2585991|NCT02339285|Secondary|Change in Alpha Oscillation Power From Resting State EEG Recordings on the First of Stimulation to 4 Weeks After Completion of Intervention|The investigators will compare alpha oscillation power from resting state EEG recordings on the first day of stimulation (baseline) and at the follow-up visit four weeks after completion of the intervention. The investigators will also collect EEG on the fifth day of stimulation. The investigators will use each of the three EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers. As the stimulation paradigm stimulates the frontal brain regions, the investigators will analyze alpha power change in all brain regions as well as frontal regions.|Baseline to F2|Only participants that completed all sessions are used in this task (per protocol participants); N = 26|||decibel (dB)||Standard Deviation|Mean
2585992|NCT02339285|Secondary|Change in Alpha Oscillation Power From Resting State EEG Recordings on the First and Last Day of Stimulation|The investigators will compare alpha oscillation power from resting state EEG recordings on the first day of stimulation (baseline) and last day of stimulation. The investigators will also collect EEG recordings data at a visit four weeks after completion of the intervention (F2). The investigators will use each of the three EEG recordings as data to analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers. As the stimulation paradigm stimulates the frontal brain regions, the investigators will analyze alpha power change in all brain regions as well as frontal regions.|Baseline to Day 5 of Stimulation|Only participants that completed all sessions are used in this task (per protocol participants); N = 26|||decibel (dB)||Standard Deviation|Mean
2585993|NCT02339285|Primary|Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score|The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. This measurement will be taken at baseline (Day 1 of Stimulation), Day 5 of Stimulation, 2 weeks after completion of the intervention (F1), and 4 weeks after completion of the intervention (F2). A comparison of MADRS scores between baseline and F2 is the primary outcome measure (measured as change from baseline). In these results, negative values will indicate a decrease in depressive symptoms.|Baseline to F2 (4 weeks after completion of the intervention)||||units on a scale||Standard Deviation|Mean
2586017|NCT02338973|Secondary|Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 52|Change in central retinal thickness as measured on Cirrus OCT from baseline as compared to Week 52 by participant in both study and fellow eyes.|Week 52|Cirrus OCT values are presented for Baseline and Week 52 and the change at Week 52 from Baseline for each participant (study and fellow eye).|||μm|||Number
2585994|NCT02339246|Primary|Evaluation of AUC(0-24) for Envarsus XR, Astagraf XL and Prograf.|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling times was used to calculate AUC(0-24).~Nominal time points used were:~Prograf sampling strategy (21 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, and 24.~Envarsus XR sampling strategy (18 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, 24, and 27.~Astagraf XL sampling strategy (17 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, and 24."|8 days|One patient in the Envarsus XR arm was excluded from the analysis due to non compliance.|||hr*ng/mL||Standard Deviation|Mean
2585995|NCT02339246|Primary|Evaluation of C(Max) for Envarsus XR, Astagraf XL and Prograf.|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling times was used to calculate C(max).~Nominal time points used were:~Prograf sampling strategy (21 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, and 24.~Envarsus XR sampling strategy (18 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, 24, and 27.~Astagraf XL sampling strategy (17 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, and 24."|8 days|One patient in the Envarsus XR arm was excluded from the analysis due to non compliance.|||ng/mL||Standard Deviation|Mean
2585996|NCT02339246|Primary|Evaluation of T(Max) for Envarsus XR, Astagraf XL and Prograf.|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling times was used to calculate T(max).~Nominal time points used were:~Prograf sampling strategy (21 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, and 24.~Envarsus XR sampling strategy (18 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, 24, and 27.~Astagraf XL sampling strategy (17 samples): Pre-dose (C0) and then 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 18, 21, and 24."|8 days|One patient in the Envarsus XR arm was excluded from the analysis due to non compliance.|||hour||95% Confidence Interval|Median
2585997|NCT02339155|Secondary|Number of Participants With Urinalysis Parameters|Urinalysis parameters included amorphous crystals, bacteria, bilirubin, calcium oxalate (Ca Ox) crystals, choriogonadotropin beta, clarity, color, crystals of Ca Ox, erythrocytes, glucose, hemoglobin, ketone bodies, ketones, leukocyte cell clumps, leukocyte esterase, leukocytes, mucous threads, nitrite, occult blood, protein, specific gravity, squamous epithelial cells, turbidity, urobilinogen, and transitional epithelial cells. In urinalysis test plus sign (+) indicates increase in the level of the parameters.|Day 57|Safety Population|||Participants|||Number
2585998|NCT02339155|Secondary|Number of Participants With Clinical Chemistry Parameters Outside Normal Range|Blood samples were collected to evaluate clinical chemistry parameters, which included assessment of urea nitrogen (UN), creatinine, chloride, glucose, magnesium, total protein, potassium, chloride, total Carbon dioxide (CO2), sodium, calcium (cal), alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), total and direct bilirubin ( D.bili), albumin and calculated creatinine clearance. Here high is equal to above the upper limit of the normal range, low is equal to below the lower limit of the normal range. Participants are counted in the category that their value changes to (low, normal or high), unless there is no change in their category. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Day 57|Safety Population.|||Participants|||Number
2585999|NCT02339155|Secondary|Number of Participants With Hematology Parameters Outside Normal Range|Hematology parameters included assessment of platelet count, erythrocytes, leukocytes , reticulocyte count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin and hematocrit. Here high is equal to above the upper limit of the normal range, low is equal to below the lower limit of the normal range. Participants are counted in the category that their value changes to (low, normal or high), unless there is no change in their category. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to Day 57|Safety Population|||Participants|||Number
2586000|NCT02339155|Secondary|Change From Baseline in Temperature at Indicated Time Points|Temperature was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline and up to Day 183|Safety Population|||Degree celsius||Standard Deviation|Mean
2586001|NCT02339155|Secondary|Change From Baseline in Respiratory Rate at Indicated Time Points|Respiratory rate was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline and up to Day 183|Safety Population|||Breaths per minute||Standard Deviation|Mean
2586002|NCT02339155|Secondary|Change From Baseline in Heart Rate at Indicated Time Points|Heart rate was measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline and up to Day 183|Safety Population|||Beats per minute (bpm)||Standard Deviation|Mean
2586003|NCT02339155|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points|SBP and DBP were measured in semi-supine position after 5 minutes rest. Values at Day -1 were considered as Baseline values. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline and up to Day 183|Safety Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2586018|NCT02338973|Secondary|Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 8|Change in central retinal thickness as measured on Cirrus OCT from baseline as compared to Week 8 by participant in both study and fellow eyes.|Week 8|Cirrus OCT values are presented for Baseline and Week 8 and the change at Week 8 from Baseline for each participant (study and fellow eye).|||μm|||Number
2586004|NCT02339155|Secondary|Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (AE)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE resulting in death, is life threatening (ie, an immediate threat to life), inpatient hospitalization, prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect or any other situation which is medically important and may jeopardize the participant or may require medical or surgical intervention or events associated with liver injury and impaired liver function is categorized as SAE. The Safety population was comprised of all randomized participants who received at least one dose of AVA.|Up to Day 183|Safety Population|||Participants|||Number
2586005|NCT02339155|Secondary|Percentage of Participants Who Seroconvert, at Weeks 4, 8, and 26 (Days 29, 57 and 183) After the First AVA Dose, Between the AVA Alone and the AVA With Raxibacumab Treatment Groups|The percentage of participants, with corresponding 95% CI based on Wilson's method, who seroconvert (seroconversion is defined as a >4-fold increase in toxin neutralizing activity [TNA] titer) was summarized, at Weeks 4, 8 and 26 after the first AVA dose for both arms separately. Serum TNA titer was determined using a cell-based assay.|Days 29, 57 and 183|PP Population.|||Percent of Participants||95% Confidence Interval|Number
2586006|NCT02339155|Secondary|Ratio of GMC of Anti-PA Ab at Weeks 8 and 26 (Days 57 and 183) After the First AVA Dose, Between the AVA Alone and AVA With Raxibacumab Treatment Groups|Anti-PA antibody concentrations were collected at Weeks 8 and 26 after the first AVA dose. Serum AVA derived anti-PA Ab concentrations were determined using an approved immunoassay. The GMCs with corresponding 95% CI were calculated for each treatment group at each timepoint. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Days 57 and 183|PP Population.|||µg/mL||95% Confidence Interval|Geometric Mean
2586007|NCT02339155|Primary|Ratio of Geometric Mean Concentrations (GMC) of Anti-protective Antigen (PA) Antibody (Ab) at 4 Weeks (Day 29) After the First AVA Dose (Prior to the Third AVA Dose), Between the AVA Alone and the AVA With Raxibacumab Treatment Groups|Ratio of the GMC of anti-PA Ab between AVA alone and the AVA with raxibacumab treatment group was assessed to compare the immunogenicity of AVA at 4 weeks after the first AVA dose (prior to the third AVA dose). Serum AVA derived anti-PA Ab concentrations were determined using an approved immunoassay. Per Protocol (PP) population was used in analysis which comprised of all analyzable participants (those who received at least the Week 0 [Day 1] and Week 2 [Day 15] AVA doses within the protocol specified visit window; receive the raxibacumab dose, if randomized to Treatment Group 2 and; completed the primary study endpoint assessment [anti-PA Ab concentration at Week 4]).|Day 29|PP Population.|||Microgram/milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2586008|NCT02339038|Primary|Number of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs|The primary outcome was the number of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than the limit of quantification (<15IU/mL).|At least 12 weeks after completion of medication|The analyses included all patients who received at least one dose of ledipasvir-sofosbuvir|||Participants|||Count of Participants
2586009|NCT02338973|Secondary|Change in Central Visual Field Sensitivity at Day 2 and Week 5 Compared to Baseline.|Change in central visual field sensitivity as measured by microperimetry testing at Day 2 and Week 5 compared to baseline in both study and fellow eyes.|Day 2 and Week 5||||dB||Standard Deviation|Mean
2586010|NCT02338973|Secondary|Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 52|Change in central retinal thickness as measured on Spectralis OCT from baseline as compared to Week 52 by participant in both study and fellow eyes.|Week 52|Central Retinal Thickness values are presented for Baseline and Week 52 and the change at Week 52 from Baseline for each participant (study and fellow eye).|||μm|||Number
2586011|NCT02338973|Secondary|Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 8|Change in central retinal thickness as measured on Spectralis OCT from baseline as compared to Week 8 by participant in both study and fellow eyes.|Week 8|Central Retinal Thickness values are presented for Baseline and Week 8 and the change at Week 8 from Baseline for each participant (study and fellow eye).|||μm|||Number
2586012|NCT02338973|Secondary|Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 5|Change in central retinal thickness as measured on Spectralis OCT from baseline as compared to Week 5 by participant in both study and fellow eyes.|Week 5|Central Retinal Thickness values are presented for Baseline and Week 5 and the change at Week 5 from Baseline for each participant (study and fellow eye).|||μm|||Number
2586013|NCT02338973|Secondary|Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Week 2|Change in central retinal thickness as measured on Spectralis OCT from baseline as compared to Week 2 by participant in both study and fellow eyes.|Week 2|Central Retinal Thickness values are presented for Baseline and Week 2 and the change at Week 2 from Baseline for each participant (study and fellow eye).|||μm|||Number
2586014|NCT02338973|Secondary|Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Day 3|Change in central retinal thickness as measured on Spectralis OCT from baseline as compared to Day 3 by participant in both study and fellow eyes.|Day 3|Central Retinal Thickness values are presented for Baseline and Day 3 and the change at Day 3 from Baseline for each participant (study and fellow eye).|||μm|||Number
2586015|NCT02338973|Secondary|Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Day 2|Change in central retinal thickness as measured on Spectralis OCT from baseline as compared to Day 2 by participant in both study and fellow eyes.|Day 2|Central Retinal Thickness values are presented for Baseline and Day 2 and the change at Day 2 from Baseline for each participant (study and fellow eye).|||μm|||Number
2586016|NCT02338973|Secondary|Change in Central Retinal Thickness as Measured on Spectralis OCT From Baseline as Compared to Day 1|Change in central retinal thickness as measured on Spectralis OCT from baseline as compared to Day 1 by participant in both study and fellow eyes.|Day 1|Central Retinal Thickness values are presented for Baseline and Day 1 and the change at Day 1 from Baseline for each participant (study and fellow eye).|||μm|||Number
2587118|NCT02322814|Secondary|Cohort I, II, III: Overall Survival (OS)||Randomization up to death from any cause (up to approximately 5.5 years)||2021-04-30|04/2021||||
2586019|NCT02338973|Secondary|Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 5|Change in central retinal thickness as measured on Cirrus OCT from baseline as compared to Week 5 by participant in both study and fellow eyes.|Week 5|Cirrus OCT values are presented for Baseline and Week 5 and the change at Week 5 from Baseline for each participant (study and fellow eye).|||μm|||Number
2586020|NCT02338973|Secondary|Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Week 2|Change in central retinal thickness as measured on Cirrus OCT from baseline as compared to Week 2 by participant in both study and fellow eyes.|Week 2|Cirrus OCT values are presented for Baseline and Week 2 and the change at Week 2 from Baseline for each participant (study and fellow eye).|||μm|||Number
2586021|NCT02338973|Secondary|Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Day 3|Change in central retinal thickness as measured on Cirrus OCT from baseline as compared to Day 3 by participant in both study and fellow eyes.|Day 3|Cirrus OCT values are presented for Baseline and Day 3 and the change at Day 3 from Baseline for each participant (study and fellow eye).|||μm|||Number
2586022|NCT02338973|Secondary|Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Day 2|Change in central retinal thickness as measured on Cirrus OCT from baseline as compared to Day 2 by participant in both study and fellow eyes.|Day 2|Cirrus OCT values are presented for Baseline and Day 2 and the change at Day 2 from Baseline for each participant (study and fellow eye).|||μm|||Number
2586023|NCT02338973|Secondary|Change in Central Retinal Thickness as Measured on Cirrus OCT From Baseline as Compared to Day 1|Change in central retinal thickness as measured on Cirrus OCT from baseline as compared to Day 1 by participant in both study and fellow eyes.|Day 1|Central Retinal Thickness values are presented for Baseline and Day 1 and the change at Day 1 from Baseline for each participant (study and fellow eye).|||μm|||Number
2586024|NCT02338973|Secondary|Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 52|Change in maximum subretinal fluid volume as measured on OCT from baseline as compared to Week 52 by participant in both study and fellow eyes.|Week 52|Subretinal Fluid Volume values are presented for Baseline and Week 52 and the change at Week 52 from Baseline for each participant (study and fellow eye).|||mm^3|||Number
2586025|NCT02338973|Secondary|Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 8|Change in maximum subretinal fluid volume as measured on OCT from baseline as compared to Week 8 by participant in both study and fellow eyes.|Week 8|Subretinal Fluid Volume values are presented for Baseline and Week 8 and the change at Week 8 from Baseline for each participant (study and fellow eye).|||mm^3|||Number
2586026|NCT02338973|Secondary|Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 5|Change in maximum subretinal fluid volume as measured on OCT from baseline as compared to Week 5 by participant in both study and fellow eyes.|Week 5|Subretinal Fluid Volume values are presented for Baseline and Week 5 and the change at Week 5 from Baseline for each participant (study and fellow eye).|||mm^3|||Number
2586027|NCT02338973|Secondary|Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Week 2|Change in maximum subretinal fluid volume as measured on OCT from baseline as compared to Week 2 by participant in both study and fellow eyes.|Week 2|Subretinal Fluid Volume values are presented for Baseline and Week 2 and the change at Week 2 from Baseline for each participant (study and fellow eye).|||mm^3|||Number
2586028|NCT02338973|Secondary|Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Day 3|Change in maximum subretinal fluid volume as measured on OCT from baseline as compared to Day 3 by participant in both study and fellow eyes.|Day 3|Subretinal Fluid Volume values are presented for Baseline and Day 3 and the change at Day 3 from Baseline for each participant (study and fellow eye).|||mm^3|||Number
2586029|NCT02338973|Secondary|Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Day 2|Change in maximum subretinal fluid volume as measured on OCT from baseline as compared to Day 2 by participant in both study and fellow eyes.|Day 2|Subretinal Fluid Volume values are presented for Baseline and Day 2 and the change at Day 2 from Baseline for each participant (study and fellow eye).|||mm^3|||Number
2586030|NCT02338973|Secondary|Change in Maximum Subretinal Fluid Volume From Baseline as Compared to Day 1|Change in maximum subretinal fluid volume as measured on OCT from baseline as compared to Day 1 by participant in both study and fellow eyes.|Day 1|Subretinal Fluid Volume values are presented for Baseline and Day 1 and the change at Day 1 from Baseline for each participant (study and fellow eye).|||mm^3|||Number
2586031|NCT02338973|Secondary|Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 52|Change in BCVA from baseline as compared to Week 52 by participant in both study and fellow eyes.|Week 52|BCVA values are presented for Baseline and Week 52 and the change at Week 52 from Baseline for each participant (study and fellow eye).|||letters read|||Number
2586032|NCT02338973|Secondary|Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 8|Change in BCVA from baseline as compared to Week 8 by participant in both study and fellow eyes.|Week 8|BCVA values are presented for Baseline and Week 8 and the change at Week 8 from Baseline for each participant (study and fellow eye).|||letters read|||Number
2586033|NCT02338973|Secondary|Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 5|Change in BCVA from baseline as compared to Week 5 by participant in both study and fellow eyes.|Week 5|BCVA values are presented for Baseline and Week 5 and the change at Week 5 from Baseline for each participant (study and fellow eye).|||letters read|||Number
2586034|NCT02338973|Secondary|Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Week 2|Change in BCVA from baseline as compared to Week 2 by participant in both study and fellow eyes.|Week 2|BCVA values are presented for Baseline and Week 2 and the change at Week 2 from Baseline for each participant (study and fellow eye).|||letters read|||Number
2586035|NCT02338973|Secondary|Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 3|Change in BCVA from baseline as compared to Day 3 by participant in both study and fellow eyes.|Day 3|BCVA values are presented for Baseline and Day 3 and the change at Day 3 from Baseline for each participant (study and fellow eye).|||letters read|||Number
2586036|NCT02338973|Secondary|Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 2|Change in BCVA from baseline as compared to Day 2 by participant in both study and fellow eyes.|Day 2|BCVA values are presented for Baseline and Day 2 and the change at Day 2 from Baseline for each participant (study and fellow eye).|||letters read|||Number
2586037|NCT02338973|Secondary|Change in Best Corrected Visual Acuity (BCVA) From Baseline as Compared to Day 1|Change in BCVA from baseline as compared to Day 1 by participant in both study and fellow eyes.|Day 1|BCVA values are presented for Baseline and Day 1 and the change at Day 1 from Baseline for each participant (study and fellow eye).|||letters read|||Number
2586038|NCT02338973|Primary|Number of Participants Who Withdrew|The number of participants who withdrew early.|Study duration, up to 52 weeks||||Participants|||Count of Participants
2586039|NCT02338973|Primary|Number and Severity of IP-related AEs|The number and severity of adverse events related to the investigation product (IP).|Study duration, up to 52 weeks||||adverse events related to IP|||Number
2586040|NCT02338882|Secondary|Glare|Assessed as the glare area size Scale 0 to 100 Higher score = larger area = worse outcome|visit 1 (3-6 months)|Scale 0 to 100 Higher score = larger glare area = worse outcome|||units on a scale||Standard Deviation|Mean
2586041|NCT02338882|Secondary|Long Term Glare|Assessed as the glare area size Scale 0 to 100 Higher scores = larger glare area =worse outcome|Visit 2 (12-18 months)||||units on a scale||Standard Deviation|Mean
2586042|NCT02338882|Secondary|Reading Performance|Assessed as the critical print size and using the reading performance index Logarithmic Radner scale (LogRAD) Lower LogRAD equals small print size|visit 1 (3-6 months)||||LogRAD||Standard Deviation|Mean
2586043|NCT02338882|Secondary|Long Term Reading Performance|Assessed as the critical print size and using the reading performance index. Uses Radner reading chart and logarithmic Radner scale (LogRAD) Lower LogRAD equals smaller print size|Visit 2 (12-18 months)||||LogRAD||Standard Deviation|Mean
2586044|NCT02338882|Secondary|Contrast Sensitivity CSV-1000|Binocular Assessment of Contrast Sensitivity at threshold using the CSV-1000|Visit 1 [3-6 months]||||Log CS||Standard Deviation|Mean
2586045|NCT02338882|Secondary|Long Term Contrast Sensitivity CSV-1000|Binocular Assessment of Contrast Sensitivity at threshold using the Contrast sensitivity vision(CSV) CSV-1000|Visit 2 [12-18 months]||||Log CS||Standard Deviation|Mean
2586046|NCT02338882|Secondary|Pelli-Robson Binocular Contrast Sensitivity|Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test|Visit 1 [3-6 months]||||Log CS||Standard Deviation|Mean
2586047|NCT02338882|Secondary|Pelli-Robson Monocular Contrast Sensitivity|Monocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test|Visit 1 [3-6 months]||||Log CS||Standard Deviation|Mean
2586048|NCT02338882|Secondary|Long Term Binocular Pelli-Robson Contrast Sensitivity (CS)|Binocular Contrast sensitivity assessed as a contrast threshold using the Pelli-Robson test|Visit 2 [12-18 month]||||Log CS||Standard Deviation|Mean
2586049|NCT02338882|Secondary|Long Term Monocular Pelli-Robson Contrast Sensitivity (CS)|MonocularContrast sensitivity assessed as a contrast threshold using the Pelli-Robson test|Visit 2 [12-18 months]||||Log CS||Standard Deviation|Mean
2586050|NCT02338882|Primary|Long Term Defocus Curve Profiles|Assessed as a dioptric range and using the Defocus area metric|visit 2 (12-18 months)||||LogMAR||Standard Deviation|Mean
2586051|NCT02338882|Primary|Defocus Curve Profiles|Visual acuity measurement (assessed in LogMAR) taken with differing levels of optical defocus|visit 1 (3-6 months)||||LogMAR||Standard Deviation|Mean
2586052|NCT02338882|Primary|Binocular Visual Acuity (VA)|Binocular Visual acuity at 3-6 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR|Visit 1 [3-6 months]||||LogMAR||Standard Deviation|Mean
2586053|NCT02338882|Primary|Monocular Visual Acuity (VA)|Monocular Visual acuity at 3-6 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR|Visit 1 [3-6 months]||||LogMAR||Standard Deviation|Mean
2586054|NCT02338882|Primary|Long Term Binocular Visual Acuity (VA)|Binocular Visual acuity at 12-18 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR|Visit 2 [12-18 months]||||LogMAR||Standard Deviation|Mean
2586055|NCT02338882|Primary|Long Term Monocular Visual Acuity (VA)|Monocular Visual acuity at 12-18 months assessed at distance intermediate and near both corrected and uncorrected. Assessed in LogMAR|Visit 2 [12-18 months]||||LogMAR||Standard Deviation|Mean
2586056|NCT02338843|Primary|An Increased MAP, Defined as Achievement of a Day 1 MAP at 3 Hours Following the Initiation of Study Drug, of ≥ 75 mmHg OR a 10 mmHg Increase in Baseline MAP|Response with respect to mean arterial pressure (MAP) at hour 3 after the start of infusion was defined as an increase from baseline of at least 10 mm Hg or an increase to at least 75 mm Hg, without an increase in the dose of background vasopressors.|Hour 3||||Participants|||Count of Participants
2586057|NCT02338713|Secondary|Number of Participants Who Experience at Least 1 Treatment-Emergent Adverse Event (TEAE)||Baseline up to 14 days after last dose of study drug (Day 21)|The safety analysis set included all participants who were enrolled and received at least 1 dose of dummy treatment.|||participants|||Number
2586058|NCT02338713|Secondary|Tmax: Time to Reach the Cmax for Calcium||Days 3 and 6: predose and at multiple time-points (up to 24 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The PK analysis set consisted of all participants who received at least 1 dose of dummy treatment and who had at least 1 measurable serum concentration of calcium in each treatment period.|||hours||Full Range|Median
2586059|NCT02338713|Secondary|AUC(0-24): Area Under the Serum Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Calcium||Days 3 and 6: predose and at multiple time-points (up to 24 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The PK serum analysis set of included participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of calcium in each treatment period.|||hr*mmol/L||Geometric Coefficient of Variation|Geometric Mean
2586060|NCT02338713|Secondary|AUC(0-6): Area Under the Serum Concentration-Time Curve From Time 0 to 6 Hours for Calcium||Days 3 and 6: predose and at multiple time-points (up to 6 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The PK serum analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of calcium in each treatment period.|||hour*millimoles per litre (hr*mmol/L)||Geometric Coefficient of Variation|Geometric Mean
2587265|NCT02320838|Secondary|Mechanical Pain Threshold Post-treatment 40 Min.|The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton.|at 40 min. post-treatment||||N||Standard Deviation|Mean
2586061|NCT02338713|Secondary|Cmax: Maximum Observed Serum Concentration for Calcium||Days 3 and 6: predose and at multiple time-points (up to 24 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The PK serum analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of calcium in each treatment period.|||millimoles per litre(mmol/L)||Geometric Coefficient of Variation|Geometric Mean
2586062|NCT02338713|Secondary|(Ca^2+ Ae24): Amount of Calcium Excreted in Urine From Time 0 to 24 Hours Post-dose|Ca2+ Ae0-24 was calculated as the urine volume of the urine collected from 0 to 24 hours multiplied by the calcium concentration measured in urine.|Days 3 and 6: pre-dose and at multiple time-points (upto 24 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The PK urine analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable urine concentration of calcium in each treatment period.|||mmol||Geometric Coefficient of Variation|Geometric Mean
2586063|NCT02338713|Secondary|PTH AUC (0-24): Area Under the Serum Concentration-Time Curve From Time 0 to 24 Hours for Parathyroid Hormone|The PTH AUC(0-24) is a measure of the area under the serum concentration-time curve from 0 to 24 hours of parathyroid hormone.|Days 3 and 6: pre-dose and at multiple time-points (up to 24 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the calcichew D3 reporting group|The PD serum analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of parathyroid hormone in each treatment period.|||hr*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2586064|NCT02338713|Primary|(Ca^2+ Ae6): Amount of Calcium Excreted in Urine From Time 0 to 6 Hours Post-dose|Ca^2+ Ae6 was calculated as the urine volume of the urine collected from 0 to 6 hours multiplied by the calcium concentration measured in urine.|Days 3 and 6: pre-dose and at multiple time-points (upto 6 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The pharmacokinetic(PK) urine analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable urine concentration of calcium in each treatment period.|||millimoles (mmol)||Geometric Coefficient of Variation|Geometric Mean
2586065|NCT02338713|Primary|PTH AUC(0-6): Area Under the Serum Concentration-Time Curve From Time 0 to 6 Hours for Parathyroid Hormone|The PTH AUC(0-6) is a measure of the area under the serum concentration-time curve from 0 to 6 hours of parathyroid hormone.|Days 3 and 6: pre-dose and at multiple time-points (upto 6 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group|The Pharmacodynamic(PD) serum analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of parathyroid hormone in each treatment period.|||hour*picogram per milliliter (hr*pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2586066|NCT02338492|Secondary|Length of Hospital Stay|Length of hospital stay (from day of procedure to day of discharge)|From day of procedure until the day of hospital discharge (up to 36 days)||||Days||Standard Deviation|Mean
2586067|NCT02338492|Secondary|Summary of Change From Baseline Range of Motion by Visit and Test|Range of motions tests (abduction, extension, flexion, lateral rotation and medial rotation) for active range of motion and passive range of motion for the affected and unaffected arm.|Baseline, 90, 180 and 360 Days|Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.|||degrees||Standard Deviation|Mean
2586068|NCT02338492|Secondary|Summary of Procedure and Device-Related Complications Rate|Procedure and device-related complications rate presented at follow-up visits|up to day 90, up to day180 since day 90, up to 360 since day 180||||Participants|||Count of Participants
2586069|NCT02338492|Secondary|Assessment of Post-Surgery Status|Number and percent of subjects who receive physical therapy, supportive orthopedic device, or analgesic medication|Surgery & Discharge, 7-14, 30, 90, 180, 360 days||||Participants|||Count of Participants
2586070|NCT02338492|Secondary|MSTS Upper Extremity Functional Outcome|Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS) Functional Outcome. MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation.|90, 180, 360 days|Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.|||units on a scale||Standard Deviation|Mean
2586071|NCT02338492|Secondary|Activities of Daily Living Score Through All Follow-up Intervals|Change from Baseline in Activities of Daily Living Score (EORTC QLQ BM22) for each of the four scales at follow-up visits. There are two symptom scales (painful sites and pain characteristics) and two functional scales (functional interface and psychosocial aspects). All scales will be transformed to range in score from 0 to 100. A high score for the symptom scales represented a high level of symptomatology or problems, while a high score for the functional scales represents a high level of functioning.|Baseline, 90, 180 and 360 days|Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.|||units on a scale||Standard Deviation|Mean
2586072|NCT02338492|Secondary|Duration of Index Procedure|Duration of index procedure (hours)|1 Day||||hours||Standard Deviation|Mean
2586073|NCT02338492|Secondary|Pain at Palpation|Pain on palpation and clinical significance|90, 180 and 360 days|Data is presented for subjects who had follow-up visit data. Subjects who withdrew from the study prior to a visit or did not come in for a visit are excluded from the analysis at that visit.|||Participants|||Count of Participants
2586074|NCT02338492|Primary|Summary of Clinical Safety Success|No serious device related complications, no additional surgical interventions, and no device fracture, migrations, mal-alignment or loss of reduction or fixation|Up to Day 7-14, Up to Day 30, Up to Day 90, Up to Day 180, Up to Day 360||||Participants|||Count of Participants
2586075|NCT02338492|Primary|Change in Function|Change in Revised Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS). MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation.|Baseline and 90 days|Subjects who had 90 Day data|||units on a scale||Standard Error|Least Squares Mean
2586077|NCT02338362|Secondary|Adherence|Adherence was calculated from self-reported study diaries and correlated to a counter that measured number of inhaled puffs built into the placebo metered-dose inhalers|Completion of study, up to 6 weeks||||percentage of required doses||Standard Deviation|Mean
2586078|NCT02338362|Secondary|Intraocular Pressure Elevation >20% From Baseline|Participants with 2 consecutive intraocular pressure measurements exceeding 20% increase from baseline were discontinued from study.|within 6-week observation period||||participants|||Number
2586079|NCT02338362|Secondary|Side Effects|subjective (reported) and objective (slit lamp examination) side-effects attributable to study medications|from baseline to week 6||||participants|||Number
2586080|NCT02338362|Secondary|Mean Visual Acuity|best corrected logMAR visual acuity for each eye. 20/20 vision corresponds with a logMAR score of 0, while negative logMAR scores indicate better than 20/20 vision, values > 0.5 correspond with low vision, and values > 1.3 correspond with blindness.|week 6||||logMAR||Standard Deviation|Mean
2586081|NCT02338362|Primary|Mean Intraocular Pressure|Masked assessment of intraocular pressure using goldmann application tonometry. Mean of 2 measurements within 1 mmHg will be recorded.|week 6||||mmHg||Standard Deviation|Mean
2586082|NCT02338336|Primary|Incidence of Zero Lesion Measurement|Percent of participants with lesion measurement either equal to 0 or greater than 0|6 weeks|ITT|||percentage of participants|||Number
2586083|NCT02338336|Primary|Lesion Assessment|Lesion (plantar wart) size measured in millimeters. Measurement of the longest dimension was recorded. Observed data|6 weeks|Intent-to-treat|||millimeters||Standard Deviation|Mean
2586084|NCT02338193|Secondary|First Phase Insulin Secretion (IGI/HOMA-IR)|Corrected early insulin response to glucose challenge [(insulinogenic index (IGI)/ divided by fasting insulin resistance index (HOMA-IR)] with combination therapy compared to monotherapy after 24 weeks of treatment|24 weeks of treatment||||Index||Standard Deviation|Mean
2586085|NCT02338193|Secondary|Matsuda Sensitivity Index (SI OGTT)|Surrogate measure of insulin sensitivity derived from OGTT with combination therapy compared to monotherapy after 24 weeks of treatment|24 weeks of treatment||||Index||Standard Deviation|Mean
2586086|NCT02338193|Secondary|Fasting Insulin Sensitivity (HOMA-IR)|HOMA index of insulin resistance calculated from fasting insulin and glucose with combination therapy compared to monotherapy after 24 weeks of treatment|24 weeks of treatment||||Index||Standard Deviation|Mean
2586087|NCT02338193|Secondary|Mean Blood Glucose (MBG) During an OGTT|Mean blood glucose after glucose load with combination therapy compared to monotherapy after 24 weeks of treatment|24 weeks of treatment||||mg/dL||Standard Deviation|Mean
2586088|NCT02338193|Secondary|Fasting Blood Glucose (FBG)|Fasting blood glucose levels with combination therapy compared to monotherapy after 24 weeks of treatment|24 weeks of treatment||||mg/dL||Standard Deviation|Mean
2586089|NCT02338193|Secondary|Triglyceride (TRG) Levels|Triglyceride levels with combination therapy compared to monotherapy after 24 weeks of treatment|24 weeks of treatment||||mg/dL||Standard Deviation|Mean
2586090|NCT02338193|Secondary|Total Cholesterol Levels (CHOL)|Cholesterol levels with combination therapy compared to monotherapy after 24 weeks of treatment|24 weeks of treatment||||mg/dL||Standard Deviation|Mean
2586091|NCT02338193|Secondary|Liver Enzymes|ALT/AST ratio with combination therapy compared to monotherapy after 24 weeks of treatment|24 weeks of treatment||||Ratio||Standard Deviation|Mean
2586092|NCT02338193|Secondary|Systolic Blood Pressure (SBP)|Systolic blood pressure with combination therapy compared to monotherapy after 24 weeks of therapy|24 weeks of treatment||||mmHg||Standard Deviation|Mean
2586093|NCT02338193|Secondary|Diastolic Blood Pressure (DBP)|Diastolic blood pressure with combination therapy compared to monotherapy after 24 weeks of treatment|24 weeks of treatment)||||mmHG||Standard Deviation|Mean
2586094|NCT02338193|Secondary|Waist-to-height Ratio (WHtR)|Waist divided by height a( measure of central adiposity) with combination therapy compared to monotherapy after 24 weeks of therapy|24 weeks of treatment||||ratio||Standard Deviation|Mean
2586095|NCT02338193|Secondary|Waist- to -Hip Ratio (WHR; Measure of Central Adiposity)|Waist-to-hip ratio with combination therapy compared to monotherapy after 24 weeks of treatment|24 weeks of treatment||||Ratio||Standard Deviation|Mean
2586096|NCT02338193|Secondary|Waist Circumference (WC)|Waist size (measure of truncal adiposity)with combination therapy compared to monotherapy after 24 weeks of treatment|24 weeks of treatment||||centimeters||Standard Deviation|Mean
2586097|NCT02338193|Secondary|Body Mass Index (BMI)|BMI (measure of overall adiposity) in combination therapy compared to monotherapy after 24 weeks of treatment|24 weeks of treatment||||kg/m2||Standard Deviation|Mean
2586098|NCT02338193|Secondary|Change in Percent Body Weight|Change in percent body weight with combination therapy compared to monotherapy from baseline to week 24|Change from baseline (time 0) to study end (24 weeks)||||percent weight loss from baseline||Standard Deviation|Mean
2586099|NCT02338193|Primary|Change in Body Weight|Change in absolute body weight with combination therapy compared to monotherapy from baseline to week 24|Change from baseline (time 0) to study end (24 weeks)||||kilograms||Standard Deviation|Mean
2586100|NCT02338154|Other Pre-specified|Percentage of Late Adverse Events Divided by Late Patient Years|Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).|Events occurring >= 31 days and up through 2 years post-implant|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.|||Percentage of events/late patient years|||Number
2586101|NCT02338154|Other Pre-specified|Percentage of Subjects With Early Adverse Events|Number of Subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.|Events occurring within 30 days of procedure|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.|||Percentage of subjects|||Number
2586102|NCT02338154|Other Pre-specified|Left Ventricular End-systolic Volume (LVESV)|Left Ventricular end-systolic volume (LVESV) is the amount of (volume) of blood in the left ventricle at the end of the heart's contraction, or systole, and the beginning of filling, or diastole.|Baseline, Discharge, 3 Months, 1 Year|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.|||milliliters||Standard Error|Mean
2586103|NCT02338154|Other Pre-specified|Left Ventricular End-diastolic Volume (LVEDV)|Left Ventricular end-diastolic volume (LVEDV) is the amount of (volume) of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricle just before systole.|Baseline, Discharge, 3 Months, 1 Year|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.|||milliliters||Standard Deviation|Mean
2586104|NCT02338154|Other Pre-specified|Subject's Average Left Ventricular End-Systolic Dimension|The measurement of the heart's left ventricle at end systole.|Baseline, Discharge, 3 Months, 1 Year|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.|||centimeters||Standard Deviation|Mean
2586105|NCT02338154|Other Pre-specified|Subject's Average Left Ventricular End-Diastolic Dimension|The measurement of the heart's left ventricle at end diastole.|Baseline, Discharge, 3 Months, 1 Year|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.|||centimeters||Standard Deviation|Mean
2586106|NCT02338154|Other Pre-specified|Subject's Average Cardiac Output Index|A hemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA).|Discharge, 3 Months, 1 Year|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.|||L/min/m2||Standard Deviation|Mean
2586107|NCT02338154|Other Pre-specified|Subject's Average Cardiac Output Over Time|The amount of blood the heart pumps through the circulatory system in a minute.|Discharge, 3 months, 1 year|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.|||liters per minute||Standard Deviation|Mean
2586108|NCT02338154|Other Pre-specified|Subject's Amount of Paravalvular Leak Over Time.|Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.|Discharge, 3 months, 1 year|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.|||Participants|||Count of Participants
2586109|NCT02338154|Other Pre-specified|Subject's Amount of Aortic Valvular Regurgitation Over Time.|Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.|Discharge, 3 months, 1 year|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.|||Participants|||Count of Participants
2586110|NCT02338154|Other Pre-specified|Subject's Average Left Ventricular Ejection Fraction (LVEF)|Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. Ejection fraction is evaluated by echocardiography over time. A normal left ventricular ejection fraction (LVEF) ranges from 55% to 70%.|Baseline, discharge, 3 months, 1 year|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.|||Percentage of blood||Standard Deviation|Mean
2586111|NCT02338154|Other Pre-specified|Subject's Average Performance Index Measurements|Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time.|Discharge, 3 Months, 1 Year|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.|||cm^2/cm^2||Standard Deviation|Mean
2586112|NCT02338154|Other Pre-specified|Subject's Average Effective Orifice Area Index (EOAI) Measurements|Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.|Baseline, Discharge, 3 months, 1 year|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.|||centimeters squared/meters squared||Standard Deviation|Mean
2586113|NCT02338154|Other Pre-specified|Subject's Average Effective Orifice Area Measurements|Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.|Baseline, discharge, 3 months, 1 year|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.|||Centimeters squared||Standard Deviation|Mean
2586114|NCT02338154|Other Pre-specified|Subject's Average Peak Gradients (mmHg) Measurements Over Time|Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.|Baseline, discharge, 3 months, and 1 year|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.|||mmHg||Standard Deviation|Mean
2586115|NCT02338154|Other Pre-specified|Subject's Average Mean Gradient Measurements|Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.|Baseline, discharge, 3 months, and 1 year|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.|||mmHg||Standard Deviation|Mean
2586116|NCT02338154|Other Pre-specified|Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time|The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.|Baseline, 3 months|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.|||units on a scale||Standard Deviation|Mean
2586129|NCT02337946|Secondary|Percentage of Participants With Grade 3 or Higher Skin Toxicity|"Skin toxicity was defined as events classified with an system organ class of Skin and subcutaneous tissue disorders or a preferred term of paronychia."|Up to 28 days after discontinuation of study drug or start of subsequent therapy (data cut off: 31 August 2017; Overall study completion date)|Safety population was defined as all participants who received at least one dose of protocol treatment after randomization.|||percentage of participants|||Number
2586117|NCT02338154|Other Pre-specified|Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. Patients with cardiac disease but without resulting limitation of physical activity.~Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.~Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.~Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.~Symptoms of heart failure or the anginal syndrome may be present even at rest."|30 days, 3 months, 1 year, 2 years|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.|||Participants|||Count of Participants
2586118|NCT02338154|Other Pre-specified|Subject's Average Health Care Utilization|The average amount of time the subjects spent in the intensive care unit and the average total length of hospital stay after their heart valve replacement procedure.|Day of surgical procedure through discharge from the ICU and hospital, an average of 3 days and 11 days respectively.|The outcome is reported for subjects where data is available.|||Days||Standard Deviation|Mean
2586119|NCT02338154|Other Pre-specified|Subject's Device Technical Success|Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with the subject leaving the operating room (OR) with valve in place.|At time of surgery|The outcome is reported for subjects where data is available.|||Participants|||Count of Participants
2586120|NCT02338154|Other Pre-specified|Subject's Average Skin-to-skin Time|The time from start of skin incision to end of skin closure.|At time of surgery; an average of 3.5 hours|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.|||Minutes||Standard Deviation|Mean
2586121|NCT02338154|Other Pre-specified|Subject's Average Time Spent on Cardiopulmonary Bypass|Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.|At time of surgery; an average of 1.5 hours|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.|||minutes||Standard Deviation|Mean
2586122|NCT02338154|Primary|Subject's Average Time Spent on Cardiopulmonary Cross Clamp|Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.|At time of surgery; an average of 1 hour|This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.|||minutes||Standard Deviation|Mean
2586123|NCT02338076|Secondary|T-cell Infiltrate in Occluded Versus Occluded With Petrolatum Compared With Normal Skin.|t-cell infiltrate in occluded skin versus occluded with petrolatum skin compared with normal skin ( healthy/not occluded skin)|3 days||||cells per micrometer squared||Standard Deviation|Mean
2586124|NCT02338076|Secondary|Skin Thickness Difference Between Occluded Versus Occluded With Petrolatum Compared With Normal Skin.|skin thickness difference between occluded skin biopsy versus occluded with petrolatum skin biopsy compared with normal skin biopsy was examined|3 days||||micrometer||Standard Deviation|Mean
2586125|NCT02338076|Primary|Measurement of Innate Immune Genes (IL6, IL8, and IL1B) in Skin Biopsy Samples With Petrolatum Occlusion, Normal Skin and Occlusion Without Petrolatum to See if There is Any Difference in Expression||3 days||||log of copy number||95% Confidence Interval|Mean
2586126|NCT02338076|Primary|Expression Levels of Antimicrobial Peptides in Samples of Normal Appearing Skin and Skin Subjected to Occlusion With and Without Petrolatum.|The levels of expression of antimicrobial peptides (S100A8, S100A9, CCL20, PI3, lipocalin , human β-defensin 2 will be measured in skin biopsy samples with petrolatum occlusion, normal skin and occlusion without petrolatum to see if there is any difference in expression Please note- There is only 1 arm with 3 measures - for example, subject 1 had 3 biopsies and the outcome measure S100A8, S100A9, PI3, LIPOCALCIN, HUMAN B DEFENSIN were tested in all 3 biopsies. This is reported as the log of the number of copies. HUMAN B DEFENSIN and CCL20 was not collected. S100A7 and S100A12 were added to the analysis.|3 days||||log of copy number||95% Confidence Interval|Mean
2586127|NCT02337959|Secondary|Pair Preference Rating|During the Reader Study the radiologists completed a paired preference rating using the following scale: -3, Image displayed on left is strongly preferred; -2, Image displayed on left is moderately preferred; -1, Image displayed on left is slightly preferred; 0, No preference between the images; 1, Image displayed on right is slightly preferred; 2, Image displayed on right is moderately preferred; 3, Image displayed on right is strongly preferred. Both the predicate and investigational images were randomly assigned to appear on the right or left monitors. A spreadsheet was used for managing the data. Prior to analysis, raw ratings were converted so that those in favor of the investigational device were made positive, and ratings in favor of the predicate device were made negative.|9 weeks after last x-ray capture|cadavers and live human subjects|||units on a scale|Participants|Standard Error|Mean
2586128|NCT02337959|Primary|Radlex Scale for Diagnostic Capability Ratings|1-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an examination of this type, but likely sufficient. 3-Diagnostic Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary Good, most adequate for diagnostic purposes. Image quality that can serve as an example that should be emulated.|9 weeks after last x-ray capture|A total of 139 image pairs were included for the reader study. Of the 139 pairs, 122 were cadaver image pairs. Fifty-two (52) of the cadaver image pairs were from pediatric cadavers and seventy (70) pairs were from adult cadavers. A total of seventeen (17) adult live human subject pairs were included in the reader study.|||units on a scale|Participants|Standard Error|Mean
2586189|NCT02337387|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline through Day 85|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2586130|NCT02337946|Secondary|Percentage of Participants With Grade 2 or Higher Peripheral Neuropathy|"Peripheral neuropathy was defined as events classified with a preferred term (PT) of peripheral neuropathy according to Standardized MedDRA Queries."|Up to 28 days after discontinuation of study drug or start of subsequent therapy (data cut off: 31 August 2017; Overall study completion date)|Safety population was defined as all participants who received at least one dose of protocol treatment after randomization.|||percentage of participants||95% Confidence Interval|Number
2586131|NCT02337946|Secondary|Percentage of Participants With Adverse Events by Severity Graded Using the Common Terminology Criteria for Adverse Events (CTCAE) Grade|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.|Up to 28 days after discontinuation of study drug or start of subsequent therapy (data cut off: 31 August 2017; Overall study completion date)|Safety population was defined as all participants who received at least one dose of protocol treatment after randomization.|||percentage of participants|||Number
2586132|NCT02337946|Secondary|Percentage of Participants With Adverse Events|Safety population was defined as all participants who received at least one dose of protocol treatment after randomization.|Up to 28 days after discontinuation of study drug or start of subsequent therapy (data cut off: 31 August 2017; Overall study completion date)|Safety population was defined as all participants who received at least one dose of protocol treatment after randomization.|||percentage of participants|||Number
2586133|NCT02337946|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time from the day of randomization (Day 0) until the day of protocol treatment discontinuation determination, the day of PD decision during protocol treatment, or death from any cause, whichever came the earliest.|Up to approximately 31 months|FAS was defined as all randomized participants.|||months||95% Confidence Interval|Median
2586134|NCT02337946|Secondary|Response Rate (RR)|RR was defined as the percentage of participants who had shown complete response (CR) or partial response (PR) as the best overall response in accordance with the RECIST 1.1 criteria after randomization. The best overall response was CR, followed by PR, stable disease (SD), progressive disease (PD), and not evaluable (NE). CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters as the best overall response after randomization., SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Up to approximately 31 months|FAS was defined as all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2586135|NCT02337946|Secondary|Overall Survival (OS)|OS was defined as the time from the day of randomization (Day 0) until death by all causes.|Up to approximately 31 months|FAS was defined as all randomized participants.|||months||95% Confidence Interval|Median
2586136|NCT02337946|Secondary|Progression-Free Survival (PFS)|The PFS is the period from the date of randomization (Day 0) until the date of judgment of progression from the date of randomization, or until death by all causes, whichever comes first. The presence/absence of progressive disease (PD) was determined based on imaging, consideration of clinical PD, or survival research results. PD based on response evaluation criteria in solid tumors (RECIST) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Up to approximately 31 months|FAS was defined as all randomized participants.|||months||95% Confidence Interval|Median
2586137|NCT02337946|Primary|Progression-Free Survival Rate (PFS Rate) at 9 Months After Randomization|PFS rate was defined as the gross percentage of participants who survived with no evidence of progression from the day of randomization (Day 0) until 9 months after Day 0. The presence/absence of progressive disease (PD) was determined based on imaging, consideration of clinical PD, or survival research results. PD based on response evaluation criteria in solid tumors (RECIST) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Up to 9 months after randomization|Full Analysis Set (FAS) was defined as all randomized participants.|||percentage of participants||80% Confidence Interval|Number
2586138|NCT02337907|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog11) Total Score After 12-week Treatment|Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog11) is an 11-item cognitive subscale that objectively measures memory, language, orientation, and praxis with a total score range of 0 to 70. The greater the dysfunction, the greater the score. Least Squares Mean is actually an adjusted mean change from baseline.|Baseline and 12 weeks|FAS|||Unit on scale||Standard Error|Least Squares Mean
2586139|NCT02337907|Secondary|Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Total Score After 12-week Treatment|The CDR-SB is obtained through semi-structured interviews of patients and informants, and cognitive functioning was rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Each domain was rated on a 5-point scale of functioning as follows: 0-no impairment; 0.5-questionable impairment; 1-mild impairment; 2-moderate impairment and 3-severe impairment. Only personal care was scored on a 4-point scale without a 0.5 rating available. The higher the score, the greater the severity of dementia. Least Squares Mean is actually an adjusted mean change from baseline.|Baseline and 12 weeks|FAS|||Unit on scale||Standard Error|Least Squares Mean
2586140|NCT02337907|Secondary|Change From Baseline in Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) Total Score After 12-week Treatment|Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) is a rating scale used to assess basic and instrumental activities of daily living. In the full version of the scale, 23 items are rated by the investigator using information supplied by the caregiver. Each item has a score range varying from 0-3 to 0-5. The sum score can range from 0 to 78. Higher scores indicate better function. Least Squares Mean is actually an adjusted mean change from baseline.|Baseline and 12 weeks|FAS|||Unit on scale||Standard Error|Least Squares Mean
2586141|NCT02337907|Primary|Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment From Two Sister Trials, Present 1289.5 (NCT02240693) and 1289.7 (NCT02337907)|Neuropsychological Test Battery (NTB) response, defined as change from baseline in total z-score after 12 weeks of treatment. The NTB consists of 9 validated components. Raw scores on each of the 9 NTB tests were converted to z-scores using the baseline means and standard deviations (SDs) for each test. The resultant z-scores were averaged to obtain a total z-score, incorporating all 9 NTB tests. The NTB Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean at baseline. Negative numbers indicate values lower than baseline and positive numbers indicate values higher than baseline. The number of low test scores decreased with higher levels of intellectual abilities. Least Squares Mean is actually an adjusted mean change from baseline.|Baseline and 12 weeks|FAS (OC) and for pooled group FAS|||Z-score||Standard Error|Least Squares Mean
2586142|NCT02337907|Primary|Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment.|Neuropsychological Test Battery (NTB) response, defined as change from baseline in total z-score after 12 weeks of treatment. The NTB consists of 9 validated components. Raw scores on each of the 9 NTB tests were converted to z-scores using the baseline means and standard deviations (SDs) for each test. The resultant z-scores were averaged to obtain a total z-score, incorporating all 9 NTB tests. The NTB Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean at baseline. Negative numbers indicate values lower than baseline and positive numbers indicate values higher than baseline. Least Squares Mean is actually an adjusted mean change from baseline.|Baseline and 12 weeks|The full analysis set (FAS): FAS includes all randomised patients who were treated with at least one dose of trial medication and had a baseline and at least one post-baseline on-treatment primary endpoint NTB or secondary endpoint assessment. Observed cases (OC)|||Z-score||Standard Error|Least Squares Mean
2586143|NCT02337764|Secondary|Change From Baseline to Week 52 (LOCF) in Mean Daily OFF-time|Off-time refers to times when levodopa is not working well, causing worsening symptoms.|Baseline and Week 52 (LOCF)|Full Analysis Set included all participants who received at least 1 dose of the study drug. Here number of participants analyzed are participants evaluable for this outcome measure.|||Hours||Standard Deviation|Mean
2586144|NCT02337764|Secondary|Change From Baseline in MDS-UPDRS Part III Total Score|Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retained the four-scale structure with a reorganization of the various subscales; (Part I) non-motor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (33 scores based on 18 items), and (Part IV) motor complications (6 items). Each items had 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity.|Baseline and Week 52 (LOCF)|Full Analysis Set included all participants who received at least 1 dose of the study drug. Here number of participants analyzed are participants evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2586145|NCT02337764|Secondary|Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Total Score|Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retained the four-scale structure with a reorganization of the various subscales; (Part I) non-motor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (33 scores based on 18 items), and (Part IV) motor complications (6 items). Each items had 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part II Total Score was 0-52, with higher scores reflecting greater severity.|Baseline and Week 52 (LOCF)|Full Analysis Set included all participants who received at least 1 dose of the study drug. Here number of participants analyzed are participants evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2586146|NCT02337764|Secondary|Number of Participants With TEAE Related to Body Weight (Weight Decreased)||Up to Week 52|Safety Analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Number
2586147|NCT02337764|Secondary|Number of Participants With TEAE Related to Electrocardiograms (ECG)||Up to Week 52|Safety Analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Number
2586148|NCT02337764|Secondary|Number of Participants With Markedly Abnormal Vital Signs Values||Up to Week 52|Safety Analysis set included all participants who received at least 1 dose of study drug. Here number of participants analyzed are participants evaluable for this outcome measure.|||Participants|||Number
2586149|NCT02337764|Secondary|Number of Participants With TEAE Related to Clinical Laboratory Tests||Up to Week 52|Safety Analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Number
2586150|NCT02337764|Primary|Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||Up to Week 52|Safety Analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Number
2586163|NCT02337738|Secondary|Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Score|PDQ-39 is a self-administered questionnaire. PDQ-39 comprises of 39 questions, relating to eight key areas (Mobility, Activities of Daily Living, Emotional Well-being, Stigma, Social Support, Cognitions, Communication, and Bodily Discomfort) of health and daily activities, including both Motor and Non-motor symptoms. It is scored on a scale of zero to 100, with lower scores indicating better health and high scores more severe symptoms.|Baseline and Week 26 (LOCF)|Full Analysis Set included all randomized participants who received at least 1 dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.|||Units on a scale||Standard Error|Least Squares Mean
2586151|NCT02337751|Secondary|Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score|MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) non-motor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part II+III Total Score was 0-188, with the higher score reflecting the greater severity. Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).|Baseline to End of treatment (Week 52)|Full Analysis Set (FAS); All randomized participants who received at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants. The analyzed numbers for each arm were participants who were evaluable for this outcome measure.|||Units on a Scale||Standard Deviation|Mean
2586152|NCT02337751|Secondary|Number of Participants With TEAE Related to Body Weight (Weight Loss)|Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).|Up to 52 weeks|Safety Analysis Set: All participants who received at least 1 dose of TVP-1012 during this study and/or the preceding study (TVP-1012/CCT-001: NCT02337725). The analysis set included 103 participants who enrolled in this study and 14 participants who enrolled only in TVP-1012/CCT-001 and received TVP-1012 (totally 117 participants).|||Participants|||Count of Participants
2586153|NCT02337751|Secondary|Number of Participants With TEAE Related to Electrocardiograms (ECG) (ECG QT Prolonged)|Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).|Up to 52 weeks|Safety Analysis Set: All participants who received at least 1 dose of TVP-1012 during this study and/or the preceding study (TVP-1012/CCT-001: NCT02337725). The analysis set included 103 participants who enrolled in this study and 14 participants who enrolled only in TVP-1012/CCT-001 and received TVP-1012 (totally 117 participants).|||Participants|||Count of Participants
2586154|NCT02337751|Secondary|Number of Participants With Markedly Abnormal Vital Signs Values|"Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Here mmHg is Millimeter of mercury. Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks)."|Up to 52 weeks|"Safety Analysis Set: All participants who received at least 1 dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants.~The number of participants analyzed for each items are participants evaluable for each item within the safety analysis set."|||Participants|||Count of Participants
2586155|NCT02337751|Secondary|Number of Participants With TEAE Related to Clinical Laboratory Tests|Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).|Up to 52 weeks|Safety Analysis Set: All participants who received at least 1 dose of TVP-1012 during this study and/or the preceding study (TVP-1012/CCT-001: NCT02337725). The analysis set included 103 participants who enrolled in this study and 14 participants who enrolled only in TVP-1012/CCT-001 and received TVP-1012 (totally 117 participants).|||Participants|||Count of Participants
2586156|NCT02337751|Primary|Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).|Up to 52 weeks|Safety Analysis Set: All participants who received at least 1 dose of TVP-1012 during this study and/or the preceding study (TVP-1012/CCT-001: NCT02337725). The analysis set included 103 participants who enrolled in this study and 14 participants who enrolled only in TVP-1012/CCT-001 and received TVP-1012 (totally 117 participants).|||Participants|||Count of Participants
2586157|NCT02337738|Secondary|Number of Participants With TEAE Related to Clinical Laboratory Tests||Up to Week 26|Safety Analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2586158|NCT02337738|Secondary|Number of Participants With TEAE Related to Electrocardiograms (ECG) (Sinus Bradycardia)||Up to Week 26|Safety Analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2586159|NCT02337738|Secondary|Number of Participants With TEAE Related to Body Weight (Weight Decreased)||Up to Week 26|Safety Analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2586160|NCT02337738|Secondary|Number of Participants With Markedly Abnormal Vital Signs Values||Up to Week 26|Safety Analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2586161|NCT02337738|Secondary|Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||Up to Week 26|Safety Analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2586162|NCT02337738|Secondary|Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Each Domain Score|PDQ-39 is a self-administered questionnaire. PDQ-39 comprises of 39 questions, relating to eight key areas (Mobility, Activities of Daily Living, Emotional Well-being, Stigma, Social Support, Cognitions, Communication, and Bodily Discomfort) of health and daily activities, including both Motor and Non-motor symptoms. It is scored on a scale of zero to 100, with lower scores indicating better health and high scores more severe symptoms.|Baseline and Week 26 (LOCF)|Full Analysis Set included all randomized participants who received at least 1 dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.|||Units on a scale||Standard Error|Least Squares Mean
2586187|NCT02337387|Secondary|Pharmacokinetics: Time to Maximum Concentration (Tmax) of Blosozumab Formulations A and B||Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose|All participants who received the loading dose of blosozumab and had evaluable Tmax values.|||hours||Full Range|Median
2586164|NCT02337738|Secondary|Change From Baseline in MDS-UPDRS Part III Total Score|MDS-UPDRS retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. Each items had 0-4 ratings, where 0 (normal) to 4 (severe) and score for each was summed to calculate the total scores. The scale range for Part III Total Score was 0-136, with higher scores reflecting greater severity.|Baseline and Week 26 (LOCF)|Full Analysis Set included all randomized participants who received at least 1 dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.|||Units on a scale||Standard Error|Least Squares Mean
2586165|NCT02337738|Secondary|Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Total Score|MDS-UPDRS retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. Each items had 0-4 ratings, where 0 (normal) to 4 (severe) and score for each was summed to calculate the total scores. The scale range for Part II Total Score was 0-52, with higher scores reflecting greater severity.|Baseline and Week 26 (LOCF)|Full Analysis Set included all randomized participants who received at least 1 dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.|||Units on a scale||Standard Error|Least Squares Mean
2586166|NCT02337738|Secondary|Change From Baseline to Week 26 (LOCF) in Mean Daily OFF-time||Baseline and Week 26 (LOCF)|Full Analysis Set included all randomized participants who received at least 1 dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.|||hours per day||Standard Error|Least Squares Mean
2586167|NCT02337738|Primary|Change From Baseline in Mean Daily OFF-time During Treatment Period|Reported change from baseline during treatment period which was calculated as follows: Mean for a total of 21 days, consisting of three separate 7-day periods preceding the visits at Week 6, 14 and 26 of the treatment period - Mean for the 7 days preceding the visit at the end of the run-in period. Off-time refers to times when levodopa is not working well, causing worsening symptoms.|From Baseline to Week 26|Full Analysis Set included all randomized participants who received at least 1 dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.|||hours per day||Standard Error|Least Squares Mean
2586168|NCT02337725|Secondary|Number of Participants With TEAE Related to Clinical Laboratory Tests||Up to Week 26|Safety Analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2586169|NCT02337725|Secondary|Number of Participants With TEAE Related to Electrocardiograms (ECG)||Up to Week 26|Safety Analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2586170|NCT02337725|Secondary|Number of Participants With TEAE Related to Body Weight||Up to Week 26|Safety Analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2586171|NCT02337725|Secondary|Number of Participants With Markedly Abnormal Vital Signs Values||Up to Week 26|Safety Analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2586172|NCT02337725|Secondary|Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||Up to Week 26|Safety Analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2586173|NCT02337725|Secondary|Change From Baseline in MDS-UPDRS Part III Total Score|For MDS-UPDRS Part III (motor examination) scores, the scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity.|Baseline and Week 26 (LOCF)|Full Analysis Set included all randomized participants who received at least 1 dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.|||Units on a scale||Standard Error|Least Squares Mean
2586174|NCT02337725|Secondary|Change From Baseline in MDS-UPDRS Part II Total Score|For MDS-UPDRS Part II (motor experiences of daily living) scores, the scale range for Part II Total Score was 0-52, with higher scores reflecting greater severity.|Baseline and Week 26 (LOCF)|Full Analysis Set included all randomized participants who received at least 1 dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.|||Units on a scale||Standard Error|Least Squares Mean
2586175|NCT02337725|Secondary|Change From Baseline in MDS-UPDRS Part I Total Score|For MDS-UPDRS Part I (non-motor experiences of daily living) scores, the scale range for Part I Total Score was 0-52, with higher scores reflecting greater severity.|Baseline and Week 26 (LOCF)|Full Analysis Set included all randomized participants who received at least 1 dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.|||Units on a scale||Standard Error|Least Squares Mean
2586176|NCT02337725|Primary|Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score|Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. Each items had 0-4 ratings, where 0 (normal) to 4 (severe) and score for each was summed to calculate the total scores. The scale range for Part II+III Total Score was 0-188, with higher scores reflecting greater severity.|From Baseline to Week 26 (LOCF)|Full Analysis Set included all randomized participants who received at least 1 dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.|||Units on a scale||Standard Error|Least Squares Mean
2586188|NCT02337387|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Blosozumab Formulations A and B||Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose|All participants who received the loading dose of blosozumab and had evaluable Cmax values.|||picomoles per milliliter (pmol/mL)||Geometric Coefficient of Variation|Geometric Mean
2587210|NCT02321748|Primary|Time of Peak Concentration (Tmax) of Montelukast||Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention||||h||Full Range|Median
2586177|NCT02337491|Secondary|Overall Radiographic Response (ORR)|ORR was established based on Response Assessment in Neuro-Oncology (RANO) criteria. RANO criteria has 5 potential categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive disease (PD) and Unknown. CR: disappearance of all enhancing lesions, stable or improved non-enhancing lesions, and stable or improved clinically. PR: >= 50% decrease in sum of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, stable or improved non-enhancing lesions, and stable or improved clinically. PD: >25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition. SD: does not qualify for CR, PR or PD.|Disease was assessed radiographically for response every cycle on treatment. Treatment duration in cycles (each cycle=42 days) was a mean (SD) of 4.5 (4.4) for Cohort A and 2.5 (2.7) for Cohort B.|The analysis dataset is comprised of all enrolled participants.|||percentage of participants||95% Confidence Interval|Number
2586178|NCT02337491|Secondary|Overall Survival (OS)|OS based on Kaplan-Meier is defined as the time from study entry to death or date last known alive.|Participants were followed long-term for survival every 3 months from the end of treatment until death or lost to follow-up. Median survival follow-up was 25 months for each cohort.|The analysis dataset is comprised of all enrolled participants.|||months||95% Confidence Interval|Median
2586179|NCT02337491|Secondary|Progression-Free Survival (PFS)|PFS based on Kaplan-Meier is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD were censored at the date of last disease assessment. Per Response Assessment in Neuro-Oncology (RANO) criteria, PD is a >25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition.|Disease was assessed radiographically for response every cycle on treatment and every 6 weeks long-term. Median PFS follow-up (months) was 25 for Cohort A and 26 for Cohort B.|The analysis dataset is comprised of all enrolled participants.|||months||95% Confidence Interval|Median
2586180|NCT02337491|Primary|6-Month Progression-Free Survival (PFS6)|"PFS6 is the proportion of patients remaining alive and progression-free at 6-months from study entry.~Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria. PD is a >25% increase in sum of perpendicular diameters of all measurable enhancing lesions, significant increase of non-enhancing lesions, any new lesions, clear clinical deterioration, failure to return for evaluation due to death or deteriorating condition."|Disease was assessed radiographically for response every cycle on treatment. Treatment duration in cycles (cycle=42 days) was a mean (SD) of 4.5 (4.4) for Cohort A and 2.5 (2.7) for Cohort B. Assessment at week 72/cycle 12 pertains to the 6-month PFS.|The analysis dataset is comprised of all enrolled participants.|||proportion of participants||95% Confidence Interval|Number
2586181|NCT02337491|Primary|Pembrolizumab Dose Limiting Toxicity (DLT) [Cohort A Safety Lead-In]|A DLT is defined as an adverse event (AE) that (a) is >= grade 3 and related to the pembrolizumab with an attribution of possible, probably or definite, and (b) occurs during and/or begins during the first 42 days of study treatment, and (c) does not meet any of the following exception criteria: grade 3 immune-related AE that downgrades to <= grade 2 within 5 days, or <= grade 1/baseline within 14 days of onset; grade 3 asymptomatic endocrinopathy; grade 3 inflammatory reaction attribution to anti-tumor response; grade 3 pneumonitis, neurologic event, or uveitis that downgrades to <=grade 1 within 3 days; liver transaminase elevation <= 8 times institutional upper limit of normal (ULN); total bilirubin <= 5 times institutional ULN; any pre-existing lab abnormality that deteriorates to grade 3/4 and determine not clinically significant by Investigator, Overall Principal Investigator and Sponsor.|The evaluation for MTD occurred continuously through one cycle of treatment (42 days).|The analysis dataset is comprised of all participants who enrolled in the safety lead-in study.|||participants with DLT|||Number
2586182|NCT02337491|Primary|Pembrolizumab Maximum Tolerated Dose (MTD) [Cohort A Safety Lead-In]|The MTD of pembrolizumab in combination with bevacizumab 10 mg/kg intravenously (IV) on days 1, 15 and 29 of each 42 day cycle is determined by the number of participants who experience a dose limiting toxicity (DLT) at the various regimens of dosing frequency of pembrolizumab 200 mg IV administered under evaluation. See subsequent primary outcome measure for the DLT definition. The MTD is defined as the pembrolizumab dose frequency regimen at which fewer than one-third of participants experience a DLT. If de-escalation does not occur per design, then the starting dose is the Recommended Phase II Dose (RP2D).|one cycle/42 days|The analysis dataset is comprised of all participants who enrolled in the safety lead-in study. Only dose level 0 was evaluated and no de-escalation doses were evaluated.|||mg every 3 weeks|||Number
2586183|NCT02337478|Secondary|Overall Survival|Kaplan-Meier estimation will be used to analyze overall survival.|Up to 6 months after completion of therapy||||months||95% Confidence Interval|Mean
2586184|NCT02337478|Secondary|Response Rate (CR, CRi, PR, and MLFS)|"Confidence intervals will be calculated around the estimates of the response rate (CR, CRi, PR, and MLFS) of VSLI. Assuming a response rate of 0.1, with 39 participants, 95 percent confidence intervals with a 0.09 margin of error (0.01, 0.19) or a margin of error of 0.16 around a response rate of 0.5 will be created.~(Complete remission (CR) bone marrow blasts <5%, absence of blasts with Auer rods; absence of extramedullary disease, absolute neutrophil count >1,000, platelet count >100,000, independence of red cell transfusions; Complete remission with incomplete recovery (CRi) all complete remission except for residual neutropenia or thrombocytopenia; partial remission (PR), decrease of bone marrow blast to 5-25%, decrease of pre-treatment bone marrow blast by at least 50%; morphologic leukemia-free state (MLFS) Bone marrow blasts <5%, absence of Aeur rods, absence of extramedullary disease, no hematologic recovery required)."|Up to 6 months after completion of study treatment||||Participants|||Count of Participants
2586185|NCT02337478|Primary|Number of Participants Able to Complete Two or More Courses of Therapy Regardless of Dose Modifications||Up to 56 days||||Participants|||Count of Participants
2586186|NCT02337387|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUC[0-tau]) of Blosozumab Formulations A and B||Day 1: Predose, 24 Hours (H), 72 H, 120 H, 168 H Post Loading Dose|All participants who received the loading dose of blosozumab and had evaluable AUC(0-tau) values.|||pmol*hours per mL||Geometric Coefficient of Variation|Geometric Mean
2605726|NCT02107014|Primary|Change in IFN-α From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2586190|NCT02337361|Secondary|Number of Participants Reporting Any Drug Use|Any drug use is defined as use of any substances, e.g., marijuana, stimulants, etc other than tobacco, in the past 3 months|baseline, 3 month, 6 month|numbers at 3 and 6 month reflect participant attrition over time|||Participants|||Count of Participants
2586191|NCT02337361|Secondary|Number of Participants Reporting Significant Depression|"Significant depression is measured as scoring above the cutoff of 6 on the total score on the 9 item Physician's health questionnaire (PHQ-9).~The 9-item Patient Health Questionnaire (PHQ-9) is a self-report measure of depression symptoms in the past two weeks. Scores can range from 0 to 27, with a score of 6 or more indicating significant depression symptoms in samples of childbearing age women."|baseline, 3 months, 6 months|numbers at 3 and 6 month reflect participant attrition over time|||Participants|||Count of Participants
2586192|NCT02337361|Secondary|Number of Participants Reporting Frequent Sugar Sweetened Beverage Use|Frequent Sugar sweetened beverage use is defined as at least weekly consumption of sugar sweetened beverages|baseline, 3 months, 6 months|numbers at 3 and 6 month reflect participant attrition over time|||Participants|||Count of Participants
2586193|NCT02337361|Secondary|Number of Participants Reporting Any Tobacco Use|Any Tobacco use is measured as any use in the past 3 months of any smoking or chewing tobacco, including cigarettes|baseline , 3 months, 6 months|numbers at follow up reflect participant attrition over time|||Participants|||Count of Participants
2586194|NCT02337361|Primary|Number of Participants Reporting Heavy Alcohol Use|heavy alcohol use is defined as self-reported maximum number of drinks in a day of 5 or more drinks|baseline, 3 month, 6 month|Numbers at 3 and 6 month reflect participant attrition|||Participants|||Count of Participants
2586195|NCT02337361|Primary|Number of Participants Reporting Weekly Alcohol Use|weekly alcohol use is defined as at least drinking once a week or more often|baseline, 3 month, 6 month|3 and 6 month numbers for each arm (study condition) reflect participant attrition over time|||Participants|||Count of Participants
2586196|NCT02337361|Primary|Number of Participants Reporting Risky Alcohol Use|"Risky alcohol use is defined as drinking 8 or more drinks in a week or 3 or more drinks in a day.~Risky alcohol use is measured by frequency of any alcohol use, number of usual and maximum drinks in a drinking day, and frequency of drinking 3 or more drinks containing alcohol"|baseline, 3 months, 6 months|3 and 6 month numbers for each arm (study condition) reflect participant attrition over time|||Participants|||Count of Participants
2586197|NCT02337062|Secondary|Time to First Violation of Criteria for PONV|Criteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the end of surgery|24 hours after end of surgery||||minutes||Inter-Quartile Range|Median
2586198|NCT02337062|Secondary|Number of Participants With Significant Nausea|"Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. Significant nausea means a score ≥ 4."|24 hours after end of surgery||||Participants|||Count of Participants
2586199|NCT02337062|Secondary|Number of Participants With Any Nausea|"Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. Any nausea means a score ≥ 1."|24 hours after the end of surgery||||Participants|||Count of Participants
2586200|NCT02337062|Secondary|Number of Participants Receiving Rescue Medication|Rescue medication defined as an antiemetic (or other medication) given with the intention of relieving nausea and/or emesis, or any incidental use of a drug known to have antiemetic potential|24 hours after the end of surgery||||Participants|||Count of Participants
2586201|NCT02337062|Secondary|Number of Participants With Emesis|Emesis is defined as vomiting (production of even the smallest amount of stomach contents) or retching (muscular movements of vomiting but without expulsion of stomach contents, usually because of an empty stomach)|24 hours after the end of surgery||||Participants|||Count of Participants
2586202|NCT02337062|Primary|Number of Participants With Complete Response|Complete response defined as no emesis and no use of rescue medication in the 24 hour period after end of surgery (defined as wound closure)|24 hours after the end of surgery|Modified intent-to-treat|||Participants|||Count of Participants
2586203|NCT02336958|Primary|Amount (ml) of Local Anesthetic Supplemented by Surgeon||during the intraoperative period||||ml||95% Confidence Interval|Mean
2586204|NCT02336958|Primary|Number of Patients With Required Supplementation of Local Anesthetic by Surgeon||during the intraoperative period||||participants|||Number
2586205|NCT02336763|Secondary|Disease-specific Survival|Cumulative incidence approach (K-M plots and Cox proportional hazard modeling) will be used to estimate disease-specific survival.|Up to 5 years|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.||||||
2586206|NCT02336763|Secondary|Distant Failure Rates|Cumulative incidence approach (Kaplan-Meier [K-M] plots and Cox proportional hazard modeling) will be used to estimate distant failure rates.|Up to 5 years|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.||||||
2586207|NCT02336763|Secondary|Overall Survival||Up to 5 years|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.||||||
2586208|NCT02336763|Secondary|Frequency and Severity of Late Toxicity Per NCI CTCAE Version 4||More than 3 months after study treatment|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.||||||
2586209|NCT02336763|Secondary|Frequency and Severity of Acute Toxicity Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4||Within 3 months of study treatment|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.||||||
2586210|NCT02336763|Primary|Reduction in Liver Metastasis||Up to 5 years|study terminated early no analysis conducted. Data was not collected from any subject for this Outcome Measure.||||||
2586211|NCT02336763|Primary|Progression-free Survival||Up to 5 years|Study terminated early no analysis conducted. Subjects would need to be followed for up to 5 years to answer this objective. Subject 1 was followed 5 months and subject 2 was followed 2 months. Therefore, data was not collected from any subject for this Outcome Measure.||||||
2587266|NCT02320838|Secondary|Mechanical Pain Threshold Post-treatment 20 Min.|The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton|at 20 min. post-treatment||||N||Standard Deviation|Mean
2586212|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 2 Weeks of Felodipine Sustained Release, Alone|The duration of the combination therapy was 2 weeks. Blood pressure was measured at week 2 of the trial.|2 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||mmHg||Standard Deviation|Mean
2586213|NCT02336607|Secondary|The Change of Pulse Wave Velocity From Baseline at 2, 14 Weeks of Felodipine Sustained Release Alone.|The duration of the combination therapy was 12 weeks. The change of pulse wave velocity was measured at week 14 of the trial.|12 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of The change of pulse wave velocity at baseline and from at least one visit after randomization.|||m/s||Standard Deviation|Mean
2586214|NCT02336607|Secondary|The Change of Pulse Wave Velocity at 12 Weeks Compare With Baseline Data of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 12 weeks. The change of pulse wave velocity was measured at week 14 of the trial.|12 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||m/s||Standard Deviation|Mean
2586215|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.|12 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||mmHg||Standard Deviation|Mean
2586216|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.|8 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||mmHg||Standard Deviation|Mean
2586217|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among the Subjects Who Reached Target at 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.|4 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||mmHg||Standard Deviation|Mean
2586218|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 12 weeks. Blood pressure was measured at week 14 of the trial.|12 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||mmHg||Standard Deviation|Mean
2586219|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.|8 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||mmHg||Standard Deviation|Mean
2586220|NCT02336607|Secondary|The Magnitude of Systolic and Diastolic Blood Pressure Change From Baseline Among All Randomized Subjects After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.|4 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||mmHg||Standard Deviation|Mean
2586221|NCT02336607|Secondary|The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 8 weeks. Blood pressure was measured at week 10 of the trial.|8 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||Percentage||95% Confidence Interval|Number
2586222|NCT02336607|Secondary|The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.|The duration of the combination therapy was 4 weeks. Blood pressure was measured at week 6 of the trial.|4 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||Percentage||95% Confidence Interval|Number
2586223|NCT02336607|Primary|The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 14 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.||14 weeks|The ITT population was defined as all patients who received at least one dose of study drug after randomization and had measurements of blood pressure at baseline and from at least one visit after randomization.|||Percentage||95% Confidence Interval|Number
2586224|NCT02336594|Secondary|Incidence of Treatment-Emergent Adverse Events||7 weeks.||||Number of Participants|||Number
2586273|NCT02336425|Secondary|Response to QGE031 Between Atopic Asthma and Non-atopic Asthma||Over 52 weeks (treatment) and 20 weeks (follow up)|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
2586225|NCT02336594|Secondary|Single Dose Pharmacodynamics (PD) Profile of RDEA3170 From Serum and Urine|PD profiles of uric acid from serum and urine. PD parameters were evaluated to assess whether any potential differences in PK for the 2 different tablets resulted in differences in uric acid excretion.|Day -1: -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours predose. Days 1, 5, 9, and 13: predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose.||||Percent||Standard Error|Mean
2586226|NCT02336594|Primary|AUC∞: Effect of Low Fat Meal on the PK of RDEA3170 Tablets|AUC∞ of RDEA3170 in low-fat fed state.|Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||ng·hr/mL||95% Confidence Interval|Geometric Mean
2586227|NCT02336594|Primary|AUC Last: Effect of Low Fat Meal on the PK of RDEA3170 Tablets|AUC last of RDEA3170 in low-fat fed state.|Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||ng·hr/mL||95% Confidence Interval|Geometric Mean
2586228|NCT02336594|Primary|Cmax: Effect of Low Fat Meal on the PK of RDEA3170 Tablets|Cmax of RDEA3170 in low-fat fed state.|Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||ng/mL||95% Confidence Interval|Geometric Mean
2586229|NCT02336594|Primary|AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Tablets|AUC∞ of RDEA3170 in high-fat fed state.|Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||ng·hr/mL||95% Confidence Interval|Geometric Mean
2586230|NCT02336594|Primary|AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Tablets|AUC last of RDEA3170 in high-fat fed state.|Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||ng·hr/mL||95% Confidence Interval|Geometric Mean
2586231|NCT02336594|Primary|Cmax: Effect of High Fat Meal on the PK of RDEA3170 Tablets|Cmax of RDEA3170 in high-fat fed state.|Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||ng/mL||95% Confidence Interval|Geometric Mean
2586232|NCT02336594|Primary|Apparent Terminal Half-life (t1/2)|t1/2 of RDEA3170 following various treatments.|Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||hr||95% Confidence Interval|Geometric Mean
2586233|NCT02336594|Primary|Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)|AUC∞ of RDEA3170 the fasted condition.|Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||ng·hr/mL||95% Confidence Interval|Geometric Mean
2586234|NCT02336594|Primary|Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)|AUC last of RDEA3170 in fasted condition.|Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||ng·hr/mL||95% Confidence Interval|Geometric Mean
2586235|NCT02336594|Primary|Time of Occurrence of Maximum Observed Concentration (Tmax)|Tmax of RDEA3170 following various treatments.|Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||hr||Full Range|Median
2586236|NCT02336594|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax of RDEA3170 in fasted condition.|Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.||||ng/mL||95% Confidence Interval|Geometric Mean
2586237|NCT02336555|Secondary|Percentage of Participants Achieving a 30 Percent or Greater Change From Baseline to Day 28 in Pain Intensity|Participants completed a pain intensity questionnaire, the Numerical Rating Scale (NRS) in the morning before taking study treatment at Baseline (Day 1) in each treatment period, and then daily from Day 1 up to Day 28 in each treatment period. The NRS assesses the intensity of PHN pain during the preceding 24-hour period on an 11-point numeric rating scale (range: 0=no pain to 10=pain as bad as you can imagine). This was a binary outcome denoting whether the participant reported a percent change from Baseline to Week 4 (Days 22 to 28) in the mean pain intensity score greater than 30%. The percentage of participants who reported a 30% or greater change from Baseline to Day 28 of each treatment period is presented.|Baseline and Day 28 in each treatment period (Up to approximately 63 days)|The population consisted of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||Percentage of participants||95% Confidence Interval|Number
2586238|NCT02336555|Primary|Change From Baseline in Pain Intensity at Week 4 of Each Treatment Period|Participants completed a pain intensity questionnaire, the Numerical Rating Scale (NRS), in the morning prior to taking study treatment at Baseline (Day 1) in each treatment period, and then daily up to Day 28 in each treatment period. The NRS assesses the intensity of Post-herpetic Neuralgia (PHN) pain during the preceding 24-hour period on an 11-point numeric rating scale (range: 0=no pain to 10=pain as bad as you can imagine). The mean score in pain intensity of Week 4 (Days 22 to 28) minus the mean score at Baseline is presented, with a negative change representing improvement (or reduction) in pain intensity. In comparison to placebo, a reduction (difference in the change from Baseline) of 1 on the 11-point NRS is expected.|Baseline and Days 22-28 of each treatment period (Up to approximately 63 days)|The population consisted of participants who complied with the protocol sufficiently to ensure that these data would be likely to exhibit the effects of treatment, according to the underlying scientific model.|||Score on a scale||95% Confidence Interval|Mean
2586239|NCT02336451|Secondary|Pharmacokinetics (PK) of Ceritinib in Study Population: Cmax & Cmin (Trough)|Cmax is the maximum (peak) concentration of drug in plasma. Cmin is the minimum (trough) concentration of drug in plasma. Sparse blood samples for ceritinib PK evaluation in plasma were collected on C1D1 up to C6D1 from all patients who received at least one dose of investigational study treatment.|Cmax: Cycle 2 Day 1 (C2D1); Cmin: C1D1, C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1 - all 0hr (pre dose)|The Pharmacokinetic Analysis Set (PAS) comprised of all the patients who received at least one (full or partial) dose of ceritinib and provided at least one evaluable PK blood sample.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2586240|NCT02336451|Secondary|Overall Survival (OS)|OS was defined as time from the date of first dose of ceritinib to the date of death due to any cause. The OS time for patients who were alive at the end of the study or were lost to follow-up was censored at the date of last contact.|24 weeks|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib|||months||95% Confidence Interval|Median
2586241|NCT02336451|Secondary|Progression Free Survival (PFS) (Whole Body) Per RECIST 1.1 Per Investigator & BIRC Assessment|PFS was defined as the time from the date of the first dose of ceritinib to the date of the first radiologically documented disease progression in the whole body per RECIST 1.1 or death due to any cause. A patient who had not progressed or died at the date of the analysis was censored at the time of the last adequate tumor evaluation on or before the cut-off date.|43 months|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib|||months||95% Confidence Interval|Median
2586242|NCT02336451|Secondary|Duration of Response (DOR) (Whole Body) Per RECIST 1.1 Per BIRC Assessment|DOR was defined as the time from the first documented response (PR or CR) to the date of the first documented disease progression or death due to any cause, amongst patients with a confirmed response (PR or CR) in the whole body per RECIST 1.1 per BIRC. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed & non-target lesions are not in progression or in complete response.|43 months|A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had confirmed CR or PR.|||months||95% Confidence Interval|Median
2586243|NCT02336451|Secondary|Duration of Response (DOR) (Whole Body) Per RECIST 1.1 Per Investigator Assessment|DOR was defined as the time from the first documented response (PR or CR) to the date of the first documented disease progression or death due to any cause, amongst patients with a confirmed response (PR or CR) in the whole body per RECIST 1.1 per Investigator. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed & non-target lesions are not in progression or in complete response.|43 months|A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had confirmed CR or PR.|||months||95% Confidence Interval|Median
2586244|NCT02336451|Secondary|Time to Tumor Response (TTR) (Whole Body) Per RECIST 1.1 Per BIRC Assessment|TTR was defined as the time from the date of the first dose of ceritinib to the date of the first documented response (CR or PR) in the whole body as assessed by RECIST 1.1 criteria per BIRC assessment. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed & non-target lesions are not in progression or in complete response.|43 months|A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had confirmed CR or PR.|||months||Full Range|Median
2586245|NCT02336451|Secondary|Time to Tumor Response (TTR) (Whole Body) Per RECIST 1.1 Per Investigator Assessment|TTR was defined as the time from the date of the first dose of ceritinib to the date of the first documented response (CR or PR) in the whole body as assessed per RECIST 1.1 criteria per Investigator. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed & non-target lesions are not in progression or in complete response.|43 months|A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had confirmed CR or PR.|||months||Full Range|Median
2586246|NCT02336451|Secondary|Disease Control Rate (DCR) (Whole Body) Per RECIST 1.1 Per BIRC Assessment|DCR: defined as percentage of participants with a best overall response of CR, PR or stable disease (SD) in the whole body, per RECIST 1.1 by BIRC. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), & no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed and non-target lesions are not in progression or in complete response. SD: Neither sufficient shrinkage in the target lesion to qualify for PR or CR nor an increase in lesions which would qualify for PD & non-target lesions are not in unequivocal progression.|43 months|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
2586247|NCT02336451|Secondary|Overall Response Rate (ORR) (Whole Body) Per RECIST 1.1 Per BIRC Assessment|Overall response rate ORR is defined as the percentage of participants with a best overall confirmed response of complete response (CR) or partial response (PR) in the whole body as assessed per RECIST 1.1 by BIRC. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed & non-target lesions are not in progression or in complete response.|43 months|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
2586248|NCT02336451|Secondary|Duration of Extracranial Response (DOER) Per RECIST 1.1 Per BIRC Assessment|DOER was defined as the time from the first documented response (PR or CR) outside of the brain to the date of the first documented disease progression outside of the brain or death due to any cause, amongst patients with a confirmed response (PR or CR) outside of the brain per RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed & non-target lesions are not in progression or in complete response.|43 months|A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had confirmed CR or PR.|||months||95% Confidence Interval|Median
2586249|NCT02336451|Secondary|Duration of Extracranial Response (DOER) Per RECIST 1.1 Per Investigator Assessment|DOER was defined as the time from the first documented response (PR or CR) outside of the brain to the date of the first documented disease progression outside of the brain or death due to any cause, amongst patients with a confirmed response (PR or CR) outside of the brain per RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed & non-target lesions are not in progression or in complete response.|43 months|A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had confirmed CR or PR.|||months||95% Confidence Interval|Median
2586250|NCT02336451|Secondary|Time to Extracranial Tumor Response (TTER) Per RECIST 1.1 Per BIRC Assessment|TTER was defined as the time from the date of the first dose of ceritinib to the date of the first documented response (CR or PR) outside of the brain as assessed per RECIST 1.1 criteria. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed & non-target lesions are not in progression or in complete response.|43 months|A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had confirmed CR or PR.|||months||Full Range|Median
2586251|NCT02336451|Secondary|Time to Extracranial Tumor Response (TTER) Per RECIST 1.1 Per Investigator Assessment|TTER was defined as the time from the date of the first dose of ceritinib to the date of the first documented response (CR or PR) outside of the brain as assessed per RECIST 1.1 criteria. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed & non-target lesions are not in progression or in complete response.|43 months|A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had confirmed CR or PR.|||months||Full Range|Median
2586252|NCT02336451|Secondary|Extracranial Disease Control Rate (EDCR) Per RECIST 1.1 Per Investigator & BIRC Assessment at Weeks 8 & 16|EDCR at weeks 8 & 16: defined as percentage of parts. with CR, PR or SD outside of the brain at Wk 8 & 16 extracranial tumor evaluations respectively, per RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), & no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed and non-target lesions are not in progression or in complete response. SD: Neither sufficient shrinkage in the target lesion to qualify for PR or CR nor an increase in lesions which would qualify for PD & non-target lesions are not in unequivocal progression.|Week 8 and Week 16|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
2586253|NCT02336451|Secondary|Extracranial Disease Control Rate (EDCR) Per RECIST 1.1 Per Investigator & BIRC Assessment - Overall|EDCR overall was defined as the percentage of participants with a best overall response of CR, PR or SD outside of the brain as assessed per RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), & no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed and non-target lesions are not in progression or in complete response. SD: Neither sufficient shrinkage in the target lesion to qualify for PR or CR nor an increase in lesions which would qualify for PD & non-target lesions are not in unequivocal progression.|43 months|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
2586254|NCT02336451|Secondary|Overall Extracranial Response Rate (OERR) Per RECIST 1.1 Per Investigator & BIRC Assessment|OERR was defined as the percentage of participants with a best overall confirmed response of CR or PR outside of the brain, as assessed per RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed & non-target lesions are not in progression or in complete response.|43 months|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
2586255|NCT02336451|Secondary|Duration of Intracranial Response (DOIR) by Modified RECIST 1.1 Per BIRC Assessment|Defined as the time from the first documented response (PR or CR) in the brain to the date of the first documented disease progression in the brain or death due to any cause, amongst participants with measurable brain metastases at baseline and a confirmed response (PR or CR) in the brain as per modified RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed & non-target lesions are not in progression or in complete response.|43 months|A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had measurable brain metastases at baseline and confirmed CR or PR.|||months||95% Confidence Interval|Median
2586274|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Total Daily Symptom Score||Over 52 weeks (Treatment) and 20 weeks (follow-up)|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
2586256|NCT02336451|Secondary|Duration of Intracranial Response (DOIR) by Modified RECIST 1.1 Per Investigator Assessment|Defined as the time from the first documented response (PR or CR) in the brain to the date of the first documented disease progression in the brain or death due to any cause, amongst participants with measurable brain metastases at baseline and a confirmed response (PR or CR) in the brain as per modified RECIST 1.1. This was applied to the brain only. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed & non-target lesions are not in progression or in complete response.|43 months|A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had measurable brain metastases at baseline and confirmed CR or PR.|||months||95% Confidence Interval|Median
2586257|NCT02336451|Secondary|Time to Intracranial Tumor Response (TTIR) Per Modified RECIST 1.1 Per BIRC Assessment|TTIR was defined as the time from the date of the first dose of ceritinib to the date of the first documented response (CR or PR) in the brain as assessed per modified RECIST 1.1 criteria for patients with measurable brain metastases at baseline. This was applied to the brain only. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed & non-target lesions are not in progression or in complete response.|43 months|A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had measurable brain metastases at baseline and confirmed CR or PR.|||months||Full Range|Median
2586258|NCT02336451|Secondary|Time to Intracranial Tumor Response (TTIR) Per Modified RECIST 1.1 Per Investigator Assessment|TTIR was defined as the time from the date of the first dose of ceritinib to the date of the first documented response (CR or PR) in the brain as assessed per modified RECIST 1.1 criteria for patients with measurable brain metastases at baseline. This was applied to the brain only. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed & non-target lesions are not in progression or in complete response.|43 months|A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had measurable brain metastases at baseline and confirmed CR or PR.|||months||Full Range|Median
2586259|NCT02336451|Secondary|Intracranial Disease Control Rate (IDCR) Per Modified RECIST 1.1 Per BIRC Assessment - Overall|IDCR overall: percentage of participants with a best overall response of CR, PR, SD or non-CR/non-PD in the brain, as assessed per modified RECIST 1.1 by Investigator. This was applied to the brain only. CR: Disappearance of all non-nodal target & non-target lesions. All lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), & no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed & non-target lesions are not in progression or in complete response. SD: Neither sufficient shrinkage in the target lesion to qualify for PR or CR nor an increase in lesions which would qualify for PD & non-target lesions are not in unequivocal progression.|43 months|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
2586260|NCT02336451|Secondary|Intracranial Disease Control Rate (IDCR) Per Modified RECIST 1.1 Per BIRC Assessment at Weeks 8 & 16|IDCR overall: percentage of participants with a best overall response of CR, PR, SD or non-CR/non-PD in the brain, as assessed per modified RECIST 1.1 by Investigator. This was applied to the brain only. CR: Disappearance of all non-nodal target & non-target lesions. All lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), & no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed & non-target lesions are not in progression or in complete response. SD: Neither sufficient shrinkage in the target lesion to qualify for PR or CR nor an increase in lesions which would qualify for PD & non-target lesions are not in unequivocal progression.|Week 8 and Week 16|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
2586261|NCT02336451|Secondary|Intracranial Disease Control Rate (IDCR) Per Modified RECIST 1.1 Per Investigator Assessment - Overall|IDCR overall: percentage of participants with a best overall response of CR, PR, SD or non-CR/non-PD in the brain, as assessed per modified RECIST 1.1 by the Investigator. This was applied to the brain only. CR: Disappearance of all non-nodal target & non-target lesions. All lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), & no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed & non-target lesions are not in progression or in complete response. SD: Neither sufficient shrinkage in the target lesion to qualify for PR or CR nor an increase in lesions which would qualify for PD & non-target lesions are not in unequivocal progression.|43 months|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
2586275|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Peak Expiratory Flow (PEF) in the Morning and Evening||Over 52 weeks (Treatment) and 20 weeks (follow-up)|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
2586276|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Forced Expiratory Volume in 1 Second (FEV1)||Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
2586262|NCT02336451|Secondary|Intracranial Disease Control Rate (IDCR) Per Modified RECIST 1.1 Per Investigator Assessment at Weeks 8 & 16|IDCR overall: percentage of participants with a best overall response of CR, PR, SD or non-CR/non-PD in the brain, as assessed per modified RECIST 1.1 by the Investigator. This was applied to the brain only. CR: Disappearance of all non-nodal target & non-target lesions. All lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), & no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed & non-target lesions are not in progression or in complete response. SD: Neither sufficient shrinkage in the target lesion to qualify for PR or CR nor an increase in lesions which would qualify for PD & non-target lesions are not in unequivocal progression.|Week 8 and Week 16|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
2586263|NCT02336451|Secondary|Overall Intracranial Response Rate (OIRR) Per Modified RECIST 1.1 Per Blinded Independent Review Committee (BIRC) Assessment|OIRR was calculated based on response assessments in the brain for patients having measurable brain metastases at baseline. OIRR was defined as the percentage of participants with a best overall confirmed response of CR or PR in the brain as assessed per modified RECIST 1.1. This was applied to the brain only. CR: Disappearance of all non-nodal target & non-target lesions. All lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), & no new lesion is identified. PR: When all target lesions have disappeared or decreased by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) & non-target lesions are not in progression or in complete response.|43 months|A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had measurable brain metastases at baseline.|||Percentage of participants||95% Confidence Interval|Number
2586264|NCT02336451|Secondary|Overall Intracranial Response Rate (OIRR) Per Modified RECIST 1.1 Per Investigator Assessment|OIRR was calculated based on response assessments in the brain for patients having measurable brain metastases at baseline. OIRR was defined as the percentage of participants with a best overall confirmed response of CR or PR in the brain as assessed per modified RECIST 1.1. This was applied to the brain only. CR: Disappearance of all non-nodal target & non-target lesions. All lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), & no new lesion is identified. PR: When all target lesions have disappeared or decreased by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) & non-target lesions are not in progression or in complete response.|43 months|A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had measurable brain metastases at baseline.|||Percentage of participants||95% Confidence Interval|Number
2586265|NCT02336451|Secondary|Disease Control Rate (DCR) Per Investigator Assessment|DCR: percentage of parts. with best overall response of CR, PR or stable disease (SD) in the whole body, as assessed per RECIST 1.1 by investigator. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), & no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed and non-target lesions are not in progression or in complete response. SD: Neither sufficient shrinkage in the target lesion to qualify for PR or CR nor an increase in lesions which would qualify for PD & non-target lesions are not in unequivocal progression.|43 months|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
2586266|NCT02336451|Primary|Overall Response Rate (ORR) Per Investigator Assessment|Overall response rate (ORR) is defined as the percentage of participants with a best overall confirmed response of complete response (CR) or partial response (PR) in the whole body as assessed per RECIST 1.1 by the investigator. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed & non-target lesions are not in progression or in complete response.|43 months|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
2586267|NCT02336438|Primary|Mixed Meal Testing: Difference Score: Insulin Level (μU/mL)|Difference score (trt-control) of insulin level at 60 minutes post meal.|60 minutes post-meal||||Difference score, trt-control (μU/mL)||Standard Deviation|Mean
2586268|NCT02336438|Primary|Mixed Meal Testing: Difference Score: Insulin Level (μU/mL)|Difference score (trt-control) of insulin level at 30 minutes post meal.|30 minutes post-meal||||Difference score, trt-control (μU/mL)||Standard Deviation|Mean
2586269|NCT02336438|Primary|Mixed Meal Testing: Difference Score: Blood Glucose Level (mg/dL)|Difference score (trt-control) of blood glucose at 120 minutes post meal.|120 minutes post-meal||||Difference score, trt-control (mg/dL)||Standard Deviation|Mean
2586270|NCT02336438|Secondary|Difference Score: Percent of Time With Elevated Blood Glucose|Percent of time within hyperglycemic blood glucose range (bg>140) compared between treatment (glucomannan) and control phases, as captured by the continuous glucose monitoring device. Difference score calculated as % time with bg>140 in treatment condition minus % time with bg>140 in control condition.|10 days||||Difference score, trt-control (percent)||Standard Deviation|Mean
2586271|NCT02336438|Secondary|Difference Score: Percent of Time Within Normal Blood Glucose Limits|Percent of time within normal blood glucose limits (bg 70-140) compared between treatment (glucomannan) and control phases, as captured by the continuous glucose monitoring device. Difference score calculated as % time within normal limits in treatment condition minus % time within normal limits in control condition.|10 days||||Difference score, trt-control (percent)||Standard Deviation|Mean
2586272|NCT02336438|Primary|Difference Score: Percent of Time Spent in Hypoglycemic State|Percent of time within hypoglycemic blood glucose range (bg<70) compared between treatment (glucomannan) and control phases, as captured by the continuous glucose monitoring device. Difference score calculated as % time with bg<70 in treatment condition minus % time with bg<70 in control condition.|10 days||||Difference score, trt-control (percent)||Standard Deviation|Mean
2586277|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Diary (ACD)||Over 52 weeks (Treatment) and 20 weeks (follow-up)|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
2586278|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Change From Baseline in Asthma Control Questionnaire (ACQ)||Baseline, Treatment (Weeks 4, 8, 12, 16, 24, 36, 52), follow up (Weeks 60 and 72)|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
2586279|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on Time to First Asthma Exacerbations (by Severity)||Week 52|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
2586280|NCT02336425|Secondary|QGE031 Compared to Placebo in Asthma Patients (All and Either Atopic or Non-atopic) on the Reduction in Rate of Asthma Exacerbations (by Severity)||Week 52|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
2586281|NCT02336425|Secondary|QGE031 Compared to Placebo in Non-atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations||Week 52|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
2586282|NCT02336425|Secondary|QGE031 Compared to Placebo in All Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations||Week 52|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
2586283|NCT02336425|Primary|QGE031 Compared to Placebo in Atopic Asthma Patients on the Reduction in Rate of Severe Asthma Exacerbations||Week 52|Due to the small number of patients randomized and limited treatment duration (not more than 22 days in QGE031 and 29 days in Placebo), the planned statistical analysis was not performed.||||||
2586284|NCT02336282|Secondary|Oral Trail Making Part B|Oral Trail Making Part B: minimum 0 with no maximum amount of time in seconds to say the given letters and numbers. Higher scores are worse.|Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.||||seconds||Standard Deviation|Mean
2586285|NCT02336282|Secondary|Oral Trail Making Part A|Oral Trail Making Part A: minimum 0 with no maximum amount of time in seconds to say the given letters and numbers. Higher scores are worse.|Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.||||seconds||Standard Deviation|Mean
2586286|NCT02336282|Secondary|Verbal Fluency|Verbal Fluency: minimum 0 with no maximum; Count of how many words were generated in 60 seconds per letter with three letters used with no top limit. Higher scores are better.|Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.||||raw score||Standard Deviation|Mean
2586287|NCT02336282|Secondary|Digit Span Backward|Digit Span Backward, Longest Digits Backward: 0-8; higher score indicates more digits recalled. Higher scores are better.|Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.||||raw score||Standard Deviation|Mean
2586288|NCT02336282|Secondary|NIH Toolbox Working Memory Function|The Working Memory Task measures working memory. Participant recalls and sequences different visually and orally presented stimuli. Scores range from 0-28 with higher scores indicating better working memory.|After active and sham interventions administered on day one and day two of the trial||||scores on a scale||Standard Deviation|Mean
2586289|NCT02336282|Secondary|NIH Toolbox Flanker Task|The Flanker Task measures attention and inhibitory control. Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it. Scores range from 0-40 with higher scores indicating better function.|After active and sham interventions administered on day one and day two of the trial||||scores on a scale||Standard Deviation|Mean
2586290|NCT02336282|Secondary|NIH Toolbox Card Sort Task|The Card Sort Task measures cognitive flexibility and attention. Pictures are presented varying along two dimensions (e.g., shape and color). Participants must sort the pictures based on a given dimension. Scores range from 0-40 with higher scores indicating better function.|After active and sham interventions administered on day one and day two of the trial||||scores on a scale||Standard Deviation|Mean
2586291|NCT02336282|Secondary|Neurocognitive Questionnaire: CCSS-NCQ|"The CCSS-NCQ is a 25 item self-report questionnaire to assess cognitive function across multiple domains in cancer survivors. Participant responses range from 1-3 for each item with higher score indicating more problems. Domain scores are created by summing the relevant item scores for each domain. Score ranges:~NCQ Task Efficiency: 9-27.~NCQ Emotional Regulation: 3-9.~NCQ Organization: 3-9.~NCQ Memory: 4-12."|Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.||||scores on a scale||Standard Deviation|Mean
2586292|NCT02336282|Secondary|Digit Span Forward|Digit Span Forward, Longest Digits Forward: 0-9; higher score indicates more digits recalled. Higher scores are better.|Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.||||raw score||Standard Deviation|Mean
2586293|NCT02336282|Primary|Feasibility of At Home tDCS Intervention|This outcome measures the feasibility of remote tDCS and cognitive training. The trial will be considered feasible if at least 50% of the survivors are able to complete 5 sessions (tDCS along with cognitive stimulation) successfully out of 10.|5 weeks after participant enrollment|Participant enrollment for At Home Feasibility of tDCS intervention n=28 Participants Analyzed (Week 5 reported n=25)|||Participants|||Count of Participants
2586329|NCT02335710|Primary|Kinematics During Squat to Stand (S2S) Activity|Maximum weight-bearing flexion during squat to stand (S2S) activity Axial Rotation (AR) of the femur during S2S|3 months post-operative||||degrees||Standard Deviation|Mean
2605727|NCT02107014|Primary|Change in TGF-β From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2586294|NCT02336178|Secondary|Percentage of Infusions With Less Than Expected Therapeutic Effects (LETEs) in Prophylaxis Setting|Less than expected therapeutic effect (LETE) in the prophylaxis setting was defined as occurrence of any spontaneous bleed within 48 hours after a regularly scheduled prophylactic dose of BeneFIX (which was not used to treat a bleed).|Up to 6 months or 50 exposure days whichever occurred first|All participants who received at least 1 dose of prophylaxis BeneFIX treatment during the study. Participants in each arm were not mutually exclusive.|||percentage of infusions|Prophylaxis Infusions|95% Confidence Interval|Number
2586295|NCT02336178|Secondary|Percentage of Infusions With Less Than Expected Therapeutic Effects (LETEs) in On-demand Setting|"Less than expected therapeutic effect (LETE) in the on-demand setting was defined as 2 successive no response ratings recorded after 2 successive BeneFIX drug infusions, respectively."|Up to 6 months or 50 exposure days whichever occurred first|All participants who had a bleed during the study for which on-demand treatment with BeneFIX was administered. Participants in each arm were not mutually exclusive.|||percentage of infusions|Bleeding Episodes|95% Confidence Interval|Number
2586296|NCT02336178|Secondary|Average Infusion Dose and Total Factor IX Consumption in Recovery Setting|The total amount (international units [IU]) infused for each BeneFIX infusion was summed to calculate the total factor IX consumption for each participant. The average infusion dose for each participant was calculated as his total factor IX consumption (in IU) divided by the number of infusions administered.|Up to 6 months or 50 exposure days whichever occurred first|All participants who received at least 1 recovery infusion with BeneFIX during the study. Participants in each arm were not mutually exclusive.|||IU||Standard Deviation|Mean
2586297|NCT02336178|Secondary|Average Infusion Dose and Total Factor IX Consumption in Prophylaxis Setting|The total amount (international units [IU]) infused for each BeneFIX infusion was summed to calculate the total factor IX consumption for each participant. The average infusion dose for each participant was calculated as his total factor IX consumption (in IU) divided by the number of infusions administered.|Up to 6 months or 50 exposure days whichever occurred first|All participants who received at least 1 dose of prophylaxis BeneFIX treatment during the study. Participants in each arm were not mutually exclusive.|||IU||Standard Deviation|Mean
2586298|NCT02336178|Secondary|Average Infusion Dose and Total Factor IX Consumption in On-demand Setting|The total amount (international units [IU]) infused for each BeneFIX infusion was summed to calculate the total factor IX consumption for each participant. The average infusion dose for each participant was calculated as his total factor IX consumption (in IU) divided by the number of infusions administered.|Up to 6 months or 50 exposure days whichever occurred first|All participants who had a bleed during the study for which on-demand treatment with BeneFIX was administered. Participants in each arm were not mutually exclusive.|||IU||Standard Deviation|Mean
2586299|NCT02336178|Secondary|Number of BeneFIX Infusions to Treat Each New Bleed|The number of BeneFIX infusions administered to treat each new bleed was calculated by adding the on-demand initial treatment and any on-demand follow-up treatments for the same bleed. If there was more than one bleed location (eg, ankle and joint) with identical bleed start date and time, it was treated as one bleed occurrence.|Up to 6 months or 50 exposure days whichever occurred first|All participants who had a bleed during the study for which on-demand treatment with BeneFIX was administered. Participants in each arm were not mutually exclusive.|||infusions|Bleeds|Standard Deviation|Mean
2586300|NCT02336178|Secondary|Number of Infusions Resulted in the Following Response to On-demand Treatment of Bleeds: Excellent, Good, Moderate, no Response|Response was assessed using 4-point On-Demand Hemostasis Efficacy Rating Scale. Excellent means definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered; good means definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least one additional infusion administered for complete resolution of the bleeding episode, or definite pain relief and/or improvement in signs of bleeding starting after 8 hours following the infusion, with no additional infusion administered; moderate means probable or slight improvement starting after 8 hours following the infusion, with at least one additional infusion administered for complete resolution of the bleeding episode; no response means no improvement between infusions or during the 24 hour interval following an infusion, or condition worsens. Both first infusions and follow-up infusions were included.|Up to 6 months or 50 exposure days whichever occurred first|All participants who had a bleed during the study for which on-demand treatment with BeneFIX was administered. Participants in each arm were not mutually exclusive.|||infusions|Infusions||Number
2586301|NCT02336178|Secondary|Annualized Bleeding Rates (ABRs) in Participants Receiving On-demand Treatment With BeneFIX During Their On-demand Period|For on-demand period, the annualized bleeding rate (ABR) was derived for each participant by the following formula: ABR = number of bleeds in on-demand period / (number of days in on-demand period/365.25). The on-demand period was defined as the entire time of enrollment in the study (ie, from the date of the enrollment visit through the day before the Final/Early Termination visit) except time in any prophylaxis period. The breaks in the prophylaxis period were considered on-demand periods. For an on-demand regimen to have been qualified to have ABR calculated, the sum of its periods needed to be >= 14 days.|Up to 6 months or 50 exposure days whichever occurred first|All participants who received on-demand treatment during on-demand period. Participants in each arm were not mutually exclusive.|||episodes/year||Standard Deviation|Mean
2586302|NCT02336178|Secondary|Number of Spontaneous/Non-traumatic Breakthrough Bleeds Within 48 Hours of a Prophylaxis Dose of BeneFIX|The prophylaxis infusion time, bleed start time and bleed type (etiology) were used to determine the number of spontaneous, non-traumatic breakthrough bleeds that occurred <=48 hours after a prophylaxis infusion. If there was more than 1 bleed location (eg, ankle and joint) with identical bleed start date and time, it was treated as 1 bleed occurrence.|Up to 6 months or 50 exposure days whichever occurred first|All participants with any spontaneous/non-traumatic breakthrough bleeds within 48 hours of a prophylaxis dose. Participants in each arm were not mutually exclusive.|||breakthrough bleeds|Prophylaxis Infusions with Bleeds|Standard Deviation|Mean
2586330|NCT02335710|Primary|Kinematics Translations During Squat to Stand (S2S) Activity|Anterior Posterior (AP) translations of lateral femoral condyles during squat to stand (S2S) activity Anterior Posterior (AP) translations of medial femoral condyles during S2S|3 months post-operative||||mm||Standard Deviation|Mean
2586331|NCT02335710|Primary|Kinematics During Deep Knee Bend (DKB) Activity|Maximum weight-bearing flexion during DKB Axial Rotation (AR) during DKB|3 months post-operative||||degrees||Standard Deviation|Mean
2586303|NCT02336178|Secondary|Annualized Bleeding Rates (ABRs) in Participants Receiving Prophylaxis Treatment With BeneFIX During Their Prophylaxis Period|For prophylaxis period, annualized bleeding rate (ABR) was derived for each participant by the following formula: ABR = number of bleeds in prophylaxis period / (number of days in prophylaxis period/365.25). A prophylaxis period was defined as time from first prophylaxis infusion through 6 calendar days after the day of last prophylaxis infusion, or the day of study conclusion visit, whichever was earlier. A break in the prophylaxis period was any period of 28 days or longer in which no prophylaxis infusions were given. For a prophylaxis regimen to have been qualified to have ABR calculated, the sum of its periods needed to be >=14 days.|Up to 6 months or 50 exposure days whichever occurred first|All participants who participated in at least 1 day of a prophylaxis period (ie, had at least 1 prophylaxis dose). Participants in each arm were not mutually exclusive.|||episodes/year||Standard Deviation|Mean
2586304|NCT02336178|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causality with the treatment or usage. A serious adverse event (SAE) was any untoward occurrence at any dose that resulted in death; was life threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both serious and non-serious AEs. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study drug.|Up to 7 months (28 calendar days after end of 6-month or 50-exposure day study treatment)|All participants who received at least 1 dose of BeneFIX during the study. Participants in each arm were not mutually exclusive.|||participants|||Number
2586305|NCT02336178|Primary|Number of Participants With Thrombotic Events|Thrombotic event was defined as any event associated with formation of a blood clot including catheter-associated thrombi and thrombotic complications.|Up to 6 months|All participants who received at least 1 dose of BeneFIX during the study. Participants in each arm were not mutually exclusive.|||participants|||Number
2586306|NCT02336178|Primary|Number of Participants With Allergic Reactions|FIX product allergy was defined as a hypersensitivity reaction to a FIX product with symptoms such as hives, urticaria, tightness of chest, wheezing, hypotension, and anaphylaxis based on investigator's judgments.|Up to 6 months|All participants who received at least 1 dose of BeneFIX during the study. Participants in each arm were not mutually exclusive.|||participants|||Number
2586307|NCT02336178|Primary|Percentage of Participants Who Developed Factor IX Inhibitor|Factor IX (FIX) inhibitor development was defined as any Bethesda inhibitor titer greater than the laboratory's normal range or Bethesda inhibitor titer >=0.6 Bethesda Unit (BU)/mL.|Up to 6 months|All participants who received at least 1 dose of BeneFIX during the study. Participants in each arm were not mutually exclusive.|||percentage of participants||95% Confidence Interval|Number
2586308|NCT02336165|Other Pre-specified|Mean Changes From Baseline in Neurologic Function Using the Neurologic Assessment in Neuro-Oncology (NANO) Scale|"Neurologic function is assessed using the NANO Scale (Nayak et al. Neuro-oncology 2013;15[Suppl 3]:iii123), an objective and quantifiable metric of neurologic function that incorporates direct observation and testing of 8 relevant neurologic domains designed to be evaluated quickly during a routine clinic visit. Level of function scores for each neurologic domain are evaluated by a physician, physician assistant or nurse practitioner at baseline prior to initiation of study therapy, and then approximately every 8 weeks while on study treatment.~Domain functions are scored using a categorical scale ranging from 0 to 2 or 3, where higher scores represent a greater extent of functional impairment or abnormality (e.g., 0 = normal; 1 = mild/moderate impairment; 2 = severe impairment; 3 = complete impairment)."|Up to 12 months||2020-12-31|12/2020||||
2586309|NCT02336165|Secondary|Mean Changes From Baseline in the EORTC Brain Cancer Quality of Life Questionnaire (EORTC-QLQ-BN-20)|"Health-related quality of life is measured using an EORTC quality of life questionnaire designed specifically for subjects with brain tumors (BN-20). Questionnaires may be completed by the subject or with the assistance of the examiner at baseline prior to initiation of study therapy, and then approximately every 8 weeks while on study treatment (prior to discussing treatment response at each visit, whenever possible).~All single questions are answered using a categorical scale (e.g., 1 = not at all; 2 = a little; 3 = quite a bit; 4 = very much) and linearly transformed to 0 to 100 scales with 1) higher scores for a functional scale representing higher levels of functioning, 2) higher scores for the global health status/quality of life representing higher levels of global health status/quality of life, 3) and higher scores for a symptom scale representing higher level of symptoms."|Up to 12 months||2020-12-31|12/2020||||
2586310|NCT02336165|Secondary|Mean Changes From Baseline in the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30)|"Health-related quality of life is measured using the validated EORTC-QLQ-C30. Questionnaires may be completed by the subject or with the assistance of the examiner at baseline prior to initiation of study therapy, and then approximately every 8 weeks while on study treatment (prior to discussing treatment response at each visit, whenever possible).~All single questions are answered using a categorical scale (e.g., 1 = not at all; 2 = a little; 3 = quite a bit; 4 = very much) and linearly transformed to 0 to 100 scales with 1) higher scores for a functional scale representing higher levels of functioning, 2) higher scores for the global health status/quality of life representing higher levels of global health status/quality of life, 3) and higher scores for a symptom scale representing higher level of symptoms."|Up to 12 months||2020-12-31|12/2020||||
2586311|NCT02336165|Secondary|Number of Subjects With Best Overall Response|Radiographic response is assessed by consistent imaging methods every (q) 8 to 9 weeks during study treatment administration. Response is categorized per the modified RANO criteria: complete response (CR) indicates no new lesions and disappearance of all disease sustained for ≥ 4 weeks; partial response (PR) indicates no new lesions, no progression of non-measureable disease, and ≥ 50% decrease from baseline in sum of products of perpendicular diameters of measurable lesions sustained for ≥ 4 weeks; stable disease (SD) indicates non-qualification for CR, PR, or progressive disease (PD); PD indicates any new lesion or a 25% increase in sum of the products of perpendicular diameters of enhancing lesions, or clear clinical deterioration per the Investigator (Wen et al. J Clin Oncol 2010; 28(11):1963-72).|Up to 15 months|The population comprises all subjects who received any dose of durvalumab.|||Participants|||Count of Participants
2605728|NCT02107014|Primary|Change in TGF-α From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2586312|NCT02336165|Secondary|Median OS as Estimated Using the Kaplan-Meier Method|All subjects are followed for survival at least every 6 months for up to 3 years following initiation of study treatment. In Cohort A, OS is measured from the date of diagnosis until the recorded date of death or last follow-up. In Cohorts B, B2, B3, and C, OS is measured from the date of the first dose of study treatment until the recorded date of death or last follow-up. Subjects who remain alive or are lost to follow-up at the time of the analysis are censored on the date of last follow-up.|Up to 36 months|The population comprises all subjects who received any dose of durvalumab.|||weeks||95% Confidence Interval|Median
2586313|NCT02336165|Secondary|Median PFS as Estimated Using the Kaplan-Meier Method|PFS is measured from the date of the first dose of study treatment to the date of earliest PD based on modified RANO criteria or to the date of death, if PD does not occur. Per the RANO criteria, PD indicates any new lesion or a 25% increase in sum of the products of perpendicular diameters of enhancing lesions, or clear clinical deterioration per the Investigator (Wen et al. J Clin Oncol 2010; 28(11):1963-72).|Up to 15 months|The population comprises all subjects who received any dose of durvalumab.|||weeks||95% Confidence Interval|Median
2586314|NCT02336165|Secondary|Number of Participants With Treatment-emergent Adverse Events|Toxicity is graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) are reported based on clinical laboratory tests, vital sign and weight measurements, physical examinations, performance status evaluations, magnetic resonance imaging, and any other medically indicated assessments, including subject interviews, from the time informed consent is signed through 90 days after the last dose of durvalumab. AEs are considered to be treatment emergent if they occur or worsen in severity after the first dose of study treatment.|Up to 15 months|The population comprises all subjects who received any dose of durvalumab.|||Participants|||Count of Participants
2586315|NCT02336165|Primary|Overall Survival Rate at 6 Months (OS-6) as Estimated Using the Kaplan-Meier Method (Cohort C)|OS-6 is the primary endpoint of Cohort C and is the percentage of subjects who remain alive at 6 months, where OS is measured from the date of the first dose of study treatment until the recorded date of death or last follow-up. Subjects who are lost to follow-up at the time of the analysis will be censored on the date of last follow-up.|Up to 6 months|The population comprises all subjects who received any dose of durvalumab.|||percentage of participants||80% Confidence Interval|Number
2586316|NCT02336165|Primary|Progression-free Survival Rate at 6 Months (PFS-6) as Estimated Using the Kaplan-Meier Method (Cohorts B, B2, and B3)|PFS-6 is the primary endpoint of Cohorts B, B2, and B3, and is the percentage of subjects who have not progressed at 6 months, with PFS measured from the date of the first dose of study treatment to the date of earliest disease progression (PD) based on modified Response Assessment in Neuro-Oncology (RANO) criteria or to the date of death, if PD does not occur. Per the RANO criteria, PD indicates any new lesion or a 25% increase in sum of the products of perpendicular diameters of enhancing lesions, or clear clinical deterioration per the Investigator (Wen et al. J Clin Oncol 2010; 28(11):1963-72).|Up to 6 months|The population comprises all subjects who received any dose of durvalumab.|||percentage of participants||90% Confidence Interval|Number
2586317|NCT02336165|Primary|Overall Survival Rate at 12 Months (OS-12) as Estimated Using the Kaplan-Meier Method (Cohort A)|OS-12 with 90% confidence interval (CI) is the primary endpoint of Cohort A and is the percentage of subjects who remain alive at 12 months, where OS is measured from the time of diagnosis until the recorded date of death or last follow-up. Subjects who are lost to follow-up at the time of the analysis will be censored on the date of last follow-up.|Up to 12 months|The population comprises all subjects who received any dose of durvalumab.|||percent of subjects alive||90% Confidence Interval|Number
2586318|NCT02336074|Post-Hoc|Histone H4 Acetylation|Histone H4 acetylation using a H4K5/8/12/16 immunoassay with thawed PBMC derived cell lysates added to an ELISA using anti-H4 monoclonal antibody|12 weeks|Intervention arm only - histone H4 acetylation was only measured in participants in the intervention arm with the aim to compare values approximately 2 hours post vorinostat intake with values pre vorinostat intake. No data were collected from participants in the control arm.|||Fold increase pre to post vorinostat||95% Confidence Interval|Mean
2586319|NCT02336074|Secondary|Viral Inhibition|"CD8+ T cell antiviral suppressive activity was expressed as percentage elimination and determined as follows: [(fraction of p24+ cells in CD4+ T cells cultured alone) - (fraction of p24 + in CD4+ T cells cultured with CD8+ cells)]/(fraction of p24+ cells in CD4+ T cells cultured alone) × 100.~Viral inhibition Assay"|12 weeks|All participants randomized with valid assay results|||Percentage elimination||95% Confidence Interval|Mean
2586320|NCT02336074|Secondary|CD8+ T-cell Responses|Percentage of CD8+ CD107a+ IFNγ+ T cells , assessed using an optimized and qualified flow cytometry panel.|12 weeks||||% cells CD8+ CD107a+ IFNγ+||Inter-Quartile Range|Median
2586321|NCT02336074|Secondary|Percentage of CD4+ CD154+ IFNγ+ T Cells|Percentage of CD4+ CD154+ IFNγ+ T cells , assessed using an optimized and qualified flow cytometry panel.|12 weeks|All participants randomized with valid assay results|||% cells CD4+ CD154+ IFNγ+||Inter-Quartile Range|Median
2586322|NCT02336074|Secondary|Quantitative Viral Outgrowth|Number of Participants with undetectable quantitative viral outgrowth|At week 16|All participants randomized with valid assay results at week 16.|||Participants with undetectable outgrowth|||Number
2586323|NCT02336074|Secondary|Clinical Adverse Events|Clinical adverse events of any grade post-randomization.|From randomization to the final visit at week 18.|All participants randomized|||Participants|||Count of Participants
2586324|NCT02336074|Primary|Total HIV DNA From CD4 T-cells|The average of two measures taken at post-randomisation week 16 and 18|Averaged across post-randomisation week 16 and 18||||HIV-DNA copies/mill CD4+ T cells (log10)||Standard Deviation|Mean
2586325|NCT02335710|Primary|Kinematics During Ramp Down Activity|AR of the femur during ramp down activity|3 months post-operative||||degrees||Standard Deviation|Mean
2586326|NCT02335710|Primary|Kinematics Translations During Ramp Down Activity|AP Translations of the Medial and Lateral Femoral Condyles during Ramp down activity|3 months post-operative||||mm||Standard Deviation|Mean
2586327|NCT02335710|Primary|Kinematics During Ramp up Activity|AR of the femur during Ramp Up activity|3 months post-operative||||degrees||Standard Deviation|Mean
2586328|NCT02335710|Primary|Kinematics Translations During Ramp up Activity|AP Translations of the Medial and Lateral Femoral Condyles During Ramp Up activity|3 months post-operative||||mm||Standard Deviation|Mean
2586332|NCT02335710|Primary|Kinematics Translations During Deep Knee Bend (DKB) Activity|Anterior Posterior (AP) translations of medial femoral condyles during DKB Anterior Posterior (AP) translations of lateral femoral condyles during DKB|3 months post-operative||||mm||Standard Deviation|Mean
2586333|NCT02335502|Primary|Percentage of Subjects With at Least 50% Pain Reduction|Percent of subjects with at least a 50% reduction from the baseline pain VAS to the end of trial period VAS. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 100 mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level.|Baseline and End of Trial Visit|All subjects treated with the Axium implantable neurostimulator who completed their end of trial visit.|||Participants|||Count of Participants
2586334|NCT02335502|Primary|Change in Pain Intensity for Overall Pain From Pre-treatment Baseline|The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).|3, 6 and 12-Months|Differences in participants over time is due to early withdrawals and missing data|||units on a scale||Standard Deviation|Mean
2586335|NCT02335489|Primary|Change in Pain Intensity for Overall Pain From Pre-treatment Baseline|The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).|Baseline, 3, 6 and12-Months|Differences in participants over time is due to early withdrawals and missing data|||units on a scale||Standard Deviation|Mean
2586336|NCT02335424|Other Pre-specified|Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%|ORR was determined in participants who had a PD-L1 CPS of ≥10% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: complete disappearance of all lesions and no new lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per modified RECIST as assessed by Blinded Independent Central Review (BICR). Modified RECIST differs from RECIST 1.1 in that progressive disease requires confirmation by a repeat radiological assessment no less than 4 weeks from the date of first documented progressive disease. Participants with missing data were considered non-responders. The percentage of participants who had a PD-L1 positive expression of ≥10% CPS and experienced a CR or PR per modified RECIST is presented.|Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months)|All participants who received at least one dose of study treatment and had a PD-L1 positive expression of ≥10% CPS|||Percentage of participants||95% Confidence Interval|Number
2586337|NCT02335424|Other Pre-specified|Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%|ORR was determined in participants who had a PD-L1 CPS of ≥1% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: complete disappearance of all lesions and no new lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per modified RECIST as assessed by Blinded Independent Central Review (BICR). Modified RECIST differs from RECIST 1.1 in that progressive disease requires confirmation by a repeat radiological assessment no less than 4 weeks from the date of first documented progressive disease. Participants with missing data were considered non-responders. The percentage of participants who had a PD-L1 positive expression of ≥1% CPS and experienced a CR or PR per modified RECIST is presented.|Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months)|All participants who received at least one dose of study treatment and had a PD-L1 positive expression of ≥1% CPS|||Percentage of participants||95% Confidence Interval|Number
2586338|NCT02335424|Other Pre-specified|Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (Modified RECIST) in All Participants|ORR was determined in all participants and was defined as the percentage of participants who had a confirmed Complete Response (CR: complete disappearance of all lesions and no new lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per modified RECIST as assessed by Blinded Independent Central Review (BICR). Modified RECIST differs from RECIST 1.1 in that progressive disease requires confirmation by a repeat radiological assessment no less than 4 weeks from the date of first documented progressive disease. Participants with missing data were considered non-responders. The percentage of participants who experienced a CR or PR per modified RECIST is presented.|Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months)|All participants who received at least one dose of study treatment|||Percentage of participants||95% Confidence Interval|Number
2586339|NCT02335424|Secondary|Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented. These results are based on a 26-September-2018 data cutoff date.|Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months)|All participants who received at least one dose of study treatment|||Participants|||Count of Participants
2586384|NCT02334982|Secondary|Terminal Elimination Half-life (T1/2) for TAK-137_101|Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||hours||Standard Deviation|Mean
2587211|NCT02321748|Primary|Peak Plasma Concentration (Cmax) of Montelukast||Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2586340|NCT02335424|Secondary|Number of Participants Who Experienced At Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented. These safety results are based on a 26-September-2018 data cutoff date.|Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months)|All participants who received at least one dose of study treatment|||Participants|||Count of Participants
2586341|NCT02335424|Secondary|Programmed Cell Death Ligand 1 (PD-L1) Expression Status|PD-L1 expression status was determined as the percent of disease tumor cells, from newly obtained tumor biopsies, demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. The assay uses a Combined Positive Score (CPS) as a measure of PD-L1 positivity. The CPS is calculated as the number of PD-L1-positive cells divided by the number of viable tumor cells analyzed multiplied by 100. A CPS of <1% = negative; ≥1% = positive; and ≥10% = strongly positive. The number of participants categorized by PD-L1 CPS score is presented.|Day 1|All participants who received at least one dose of study treatment|||Participants|||Count of Participants
2586342|NCT02335424|Secondary|Overall Survival Rate (OS Rate) at Month 12 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%|The OS rate was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, at Month 12. OS was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 12 was calculated.|Month 12|All participants who received at least one dose of study treatment and had a PD-L1 strong positive expression of ≥10% CPS.|||Percentage of participants||95% Confidence Interval|Number
2586343|NCT02335424|Secondary|Overall Survival Rate (OS Rate) at Month 12 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%|The OS rate was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, at Month 12. OS was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 12 was calculated.|Month 12|All participants who received at least one dose of study treatment and had a PD-L1 positive expression of ≥1% CPS.|||Percentage of participants||95% Confidence Interval|Number
2586344|NCT02335424|Secondary|Overall Survival Rate (OS Rate) at Month 12 in All Participants|The OS rate was determined for all participants at Month 12 and was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 12 was calculated.|Month 12|All participants who received at least one dose of study treatment|||Percentage of participants||95% Confidence Interval|Number
2586345|NCT02335424|Secondary|Overall Survival Rate (OS Rate) at Month 6 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%|The OS rate was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, at Month 6. OS was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 6 was calculated.|Month 6|All participants who received at least one dose of study treatment and had a PD-L1 strong positive expression of ≥10% CPS.|||Percentage of participants||95% Confidence Interval|Number
2586346|NCT02335424|Secondary|Overall Survival Rate (OS Rate) at Month 6 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%|The OS rate was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, at Month 6. OS was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 6 was calculated.|Month 6|All participants who received at least one dose of study treatment and had a PD-L1 positive expression of ≥1% CPS.|||Percentage of participants||95% Confidence Interval|Number
2586347|NCT02335424|Secondary|Overall Survival Rate (OS Rate) at Month 6 in All Participants|The OS rate was determined for all participants at Month 6 and was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS rate at Month 6 was calculated.|Month 6|All participants who received at least one dose of study treatment|||Percentage of participants||95% Confidence Interval|Number
2586348|NCT02335424|Secondary|Progression Free Survival Rate (PFS Rate) at Month 12 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%|The PFS rate was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, at Month 12. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS rate at Month 12 was calculated.|Month 12|All participants who received at least one dose of study treatment and had a PD-L1 strong positive expression of ≥10% CPS.|||Percentage of participants||95% Confidence Interval|Number
2586385|NCT02334982|Secondary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-137|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
2586386|NCT02334982|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-137|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||ng*hr/mL||Standard Deviation|Mean
2586349|NCT02335424|Secondary|Progression Free Survival Rate (PFS Rate) at Month 12 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%|The PFS rate was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, at Month 12. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS rate at Month 12 was calculated.|Month 12|All participants who received at least one dose of study treatment and had a PD-L1 positive expression of ≥1% CPS.|||Percentage of participants||95% Confidence Interval|Number
2586350|NCT02335424|Secondary|Progression Free Survival Rate (PFS Rate) at Month 12 in All Participants|The PFS rate was determined in all participants at Month 12. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS rate at Month 12 was calculated.|Month 12|All participants who received at least one dose of study treatment|||Percentage of participants||95% Confidence Interval|Number
2586351|NCT02335424|Secondary|Progression Free Survival Rate (PFS Rate) at Month 6 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%|The PFS rate was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, at Month 6. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS rate at Month 6 was calculated.|Month 6|All participants who received at least one dose of study treatment and had a PD-L1 strong positive expression of ≥10% CPS.|||Percentage of participants||95% Confidence Interval|Number
2586352|NCT02335424|Secondary|Progression Free Survival Rate (PFS Rate) at Month 6 in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%|The PFS rate was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, at Month 6. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS rate at Month 6 was calculated.|Month 6|All participants who received at least one dose of study treatment and had a PD-L1 positive expression of ≥1% CPS.|||Percentage of participants||95% Confidence Interval|Number
2586353|NCT02335424|Secondary|Progression Free Survival Rate (PFS Rate) at Month 6 in All Participants|The PFS rate was determined in all participants at Month 6. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR). Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS rate at Month 6 was calculated.|Month 6|All participants who received at least one dose of study treatment|||Percentage of participants||95% Confidence Interval|Number
2586354|NCT02335424|Secondary|Overall Survival (OS) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%|OS was determined in participants who had a PD-L1 CPS of ≥10% as measured by immunohistochemistry assay. OS was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS for all participants who had a PD-L1 strong positive expression of ≥10% CPS is presented.|Through database cutoff date of 26-Sep-2018 (Up to approximately 41 months)|All participants who received at least one dose of study treatment and had a PD-L1 strong positive expression of ≥10% CPS.|||Months||95% Confidence Interval|Median
2586355|NCT02335424|Secondary|Overall Survival (OS) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%|OS was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay. OS was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS for all participants who had a PD-L1 positive expression of ≥1% CPS is presented.|Through database cutoff date of 26-Sep-2018 (Up to approximately 41 months)|All participants who received at least one dose of study treatment and had a PD-L1 positive expression of ≥1% CPS.|||Months||95% Confidence Interval|Median
2586356|NCT02335424|Secondary|Overall Survival (OS) in All Participants|OS was determined for all participants and was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last assessment. The OS for all participants is presented.|Through database cutoff date of 26-Sep-2018 (Up to approximately 41 months)|All participants who received at least one dose of study treatment|||Months||95% Confidence Interval|Median
2587267|NCT02320838|Secondary|Baseline Mechanical Pain Threshold|The pressure pain threshold will be measured by a pressure algometer and will be expressed in Newton|Baseline at 0 min.||||N||Standard Deviation|Mean
2586357|NCT02335424|Secondary|Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%|PFS was determined in participants who had a PD-L1 CPS of ≥10% as measured by immunohistochemistry assay. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS per RECIST 1.1 for all participants who had a PD-L1 strong positive expression of ≥10% CPS is presented.|Through database cutoff date of 26-Sep-2018 (Up to approximately 41 months)|All participants who received at least one dose of study treatment and had a PD-L1 strong positive expression of ≥10% CPS.|||Months||95% Confidence Interval|Median
2586358|NCT02335424|Secondary|Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%|PFS was determined in participants who had a PD-L1 CPS of ≥1% as measured by immunohistochemistry assay. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS per RECIST 1.1 for all participants who had a PD-L1 positive expression of ≥1% CPS is presented.|Through database cutoff date of 26-Sep-2018 (Up to approximately 41 months)|All participants who received at least one dose of study treatment and had a PD-L1 positive expression of ≥1% CPS.|||Months||95% Confidence Interval|Median
2586359|NCT02335424|Secondary|Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants|PFS was determined in all participants. PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). PD was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Time to scheduled tumor assessment visit rather than the actual tumor assessment visit was used in the analysis. Participants were censored at the date of their last assessment. The PFS per RECIST 1.1 for all participants is presented.|Through database cutoff date of 26-Sep-2018 (Up to approximately 41 months)|All participants who received at least one dose of study treatment|||Months||95% Confidence Interval|Median
2586360|NCT02335424|Secondary|Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%|DOR was determined in participants who had a PD-L1 CPS of ≥10%, as measured by immunohistochemistry assay, and had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% relative increase in the sum of diameters of target lesions. In addition, the sum must also have an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. The DOR per RECIST 1.1 for all participants who had a PD-L1 strong positive expression of ≥10% CPS and who had a confirmed CR or PR is presented.|From time of first documented evidence of CR or PR through database cutoff date of 26-Sep-2018 (Up to approximately 41 months)|All participants who received at least one dose of study treatment, had a PD-L1 strong positive expression of ≥10% CPS, and who had a confirmed CR or PR.|||Months||Full Range|Median
2586361|NCT02335424|Secondary|Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%|DOR was determined in participants who had a PD-L1 CPS of ≥1%, as measured by immunohistochemistry assay, and had a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% relative increase in the sum of diameters of target lesions. In addition, the sum must also have an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. The DOR per RECIST 1.1 for all participants who had a PD-L1 positive expression of ≥1% CPS and who had a confirmed CR or PR is presented.|From time of first documented evidence of CR or PR through database cutoff date of 26-Sep-2018 (Up to approximately 41 months)|All participants who received at least one dose of study treatment, had a PD-L1 positive expression of ≥1% CPS, and who had a confirmed CR or PR.|||Months||Full Range|Median
2586362|NCT02335424|Secondary|Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants|DOR was determined in participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Participants who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as ≥20% relative increase in the sum of diameters of target lesions. In addition, the sum must also have an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. The DOR per RECIST 1.1 for all participants who had a confirmed CR or PR is presented.|From time of first documented evidence of CR or PR through database cutoff date of 26-Sep-2018 (Up to approximately 41 months)|All participants who received at least one dose of study treatment and who had a confirmed CR or confirmed PR.|||Months||Full Range|Median
2586363|NCT02335424|Primary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥10%|ORR was determined in participants who had a PD-L1 CPS of ≥10% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. The percentage of participants who had a PD-L1 strong positive expression of ≥10% CPS and experienced a CR or PR per RECIST 1.1 is presented.|Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months)|All participants who received at least one dose of study treatment and had a PD-L1 strong positive expression of ≥10% CPS|||Percentage of participants||95% Confidence Interval|Number
2586364|NCT02335424|Primary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With a Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) of ≥1%|ORR was determined in participants who had a PD-L1 CPS of ≥1% as measured by immunohistochemistry assay. ORR was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. The percentage of participants who had a PD-L1 positive expression of ≥1% CPS and experienced a CR or PR per RECIST 1.1 is presented.|Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months)|All participants who received at least one dose of study treatment and had a PD-L1 positive expression of ≥1% CPS|||Percentage of participants||95% Confidence Interval|Number
2586365|NCT02335424|Primary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants|ORR was determined in all participants and was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR). Participants with missing data were considered non-responders. The percentage of participants who experienced a CR or PR per RECIST 1.1 is presented.|Through Database Cutoff Date of 26-Sep-2018 (up to approximately 41 months)|All participants who received at least one dose of study treatment|||Percentage of participants||95% Confidence Interval|Number
2586366|NCT02335346|Secondary|Percentage of Participants With Fall Events From Fall Questionnaire|Participants reported the details of their falls. Percentage equals the number of participants with fall events / total in treatment group * 100.|Baseline through Week 50|All enrolled participants who received at least one dose of study drug.|||Percentage of Participants|||Number
2586367|NCT02335346|Secondary|Change From Baseline to 50 Weeks on the Beck Depression Inventory (BDI-II) Total Score|Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.|Baseline, Week 50|All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2586368|NCT02335346|Secondary|Change From Baseline to 50 Weeks on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument.The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm with scores ranging from -0.111 to 1.0. A higher score indicates better health state.|Baseline, Week 50|All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2586369|NCT02335346|Secondary|Change From Baseline to 50 Weeks on the 36-Item Short-Form Health Survey (SF-36)|36-item Short-Form Health Survey: SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-6); social functioning (range: 2-10); bodily pain (range: 2-11); vitality (range: 4-24); mental health (range: 5-30).|Baseline, Week 50|All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2586370|NCT02335346|Secondary|Change From Baseline to 50 Weeks on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score|The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC total score was calculated for each participant at each time point for analysis as the mean total score, range 0 (none) -96 millimeter (mm)(extreme).|Baseline, Week 50|All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2586387|NCT02334982|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137|Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||hours||Full Range|Median
2587268|NCT02320838|Secondary|Change From Baseline in Nerve Conduction Amplitude ( µV)|The compound action potential amplitudes ( µV) will be measured.|Baseline,immediately after treatment at 20 min..||||µV||Standard Error|Mean
2586371|NCT02335346|Secondary|Change From Baseline to 50 Weeks on the Brief Pain Inventory-Severity and Interference Rating Short Form (BPI-SF)|Brief Pain Inventory Severity and Interference Scores: BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline, Week 50|All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2586372|NCT02335346|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) to Week 50|CSI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline, Week 50|All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2586373|NCT02335346|Secondary|Patient Global Impression-Improvement (PGI-I) at 50 Weeks|Patient Global Impressions of Improvement Scale: PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse).|Week 50|All enrolled participants who received at least one dose of study drug. Missing values due to discontinuation of study or drug, or missing data were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2586374|NCT02335346|Primary|Percentage of Participants With Drug Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)|A summary of drug related (considered by the investigator) AEs and SAEs is located in the Reported Adverse Events module. An AE is summarized if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.|Baseline through Week 53|All enrolled participants who received at least one dose of study drug.|||Percentage of participants|||Number
2586375|NCT02335229|Primary|Percentage of Subjects With at Least 50% Pain Reduction|Percent of subjects with at least a 50% reduction. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).|3, 6, 12 and 24-Month Visits|Differences in participants over time is due to early withdrawals and missing data|||Participants|||Count of Participants
2586376|NCT02335229|Primary|Change in Pain Intensity for Overall Pain From Pre-treatment Baseline|The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).|Baseline, 3, 6, 12 and 24-Month Visits|Differences in participants over time is due to early withdrawals and missing data|||units on a scale||Standard Deviation|Mean
2586377|NCT02335216|Primary|Percentage of Subjects With at Least 50% Pain Reduction|Percent of subjects with at least a 50% reduction. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum) to 10 (maximum).|3, 6 and 12-Month Visits|Differences in participants over time is due to early withdrawals and missing data|||Participants|||Count of Participants
2586378|NCT02335216|Primary|Change in Pain Intensity for Overall Pain From Pre-treatment Baseline|The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).|Baseline, 3, 6 and 12 Months|Differences in participants over time is due to early withdrawals and missing data|||units on a scale||Standard Deviation|Mean
2586379|NCT02334982|Secondary|Renal Clearance (CLr) for TAK-137|CLr is a measure of apparent clearance of the drug from the urine, calculated as CLr=Ae(0-t)/AUC(0-96).|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||liters/hour||Standard Deviation|Mean
2586380|NCT02334982|Secondary|Fraction of TAK-137 Excreted in Urine (Fe)|Fraction of drug excreted in urine, calculated as Fe=(Ae[0-t]/dose)×100.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||percent excreted||Standard Deviation|Mean
2586381|NCT02334982|Secondary|Total Amount of Drug (TAK-137) Excreted in Urine From Time 0 to Time t (Ae[0-t])|Total amount of drug excreted in urine from time 0 to time t, calculated as Sum (Cu*Vu), where Cu is the concentration of drug excreted in urine and Vu is the volume of urine excreted.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||mg||Standard Deviation|Mean
2586382|NCT02334982|Secondary|Apparent Volume of Distribution (Vz/F) for TAK-137_101|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by λz.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||liters||Standard Deviation|Mean
2586383|NCT02334982|Secondary|Apparent Clearance (CL/F) for TAK-137_101|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-inf), expressed in liters per hour (L/hr).|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||liters/hour||Standard Deviation|Mean
2586388|NCT02334982|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-137|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1|Participants from the Pharmacokinetic (PK) set, all participants who receive study drug and have at least one measureable concentration, with data available for analysis of this outcome measure.|||ng/mL||Standard Deviation|Mean
2586389|NCT02334982|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants with any markedly abnormal standard vital sign measurements was collected throughout study.|Day 1 to 14 days after the last dose of study medication|Participants from the Safety population, all participants who received at least one dose of study medication, with data available for analysis. 8 of the 47 enrolled participants participated in Cohort 4 fed.|||percentage of participants|||Number
2586390|NCT02334982|Primary|Percentage of Participants With Abnormal Safety Laboratory Findings|The percentage of participants with any markedly abnormal standard safety laboratory values was collected throughout study.|Day 1 to 14 days after the last dose of study medication (Up to 30 Days)|Participants from the Safety population, all participants who received at least one dose of study medication, with data available for analysis. 8 of the 47 enrolled participants participated in Cohort 4 fed.|||percentage of participants|||Number
2586391|NCT02334982|Primary|Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 to 14 days after the last dose of study medication(Up to 30 days)|Safety population included all participants who received at least one dose of study medication. 8 of the 47 enrolled participants participated in Cohort 4 fed.|||percentage of participants|||Number
2586392|NCT02334813|Primary|Remission Duration|Percentage of patients in ongoing remission at 6 months|6 months||||Participants|||Count of Participants
2586393|NCT02334800|Secondary|Number of Participants With Concomitant Medications|Treatments taken after the first dose of study treatment were documented as concomitant treatments.|From screening through and including Day 6 for Cohort 1, and from screening through and including Day 9 for Cohorts 2, 3, and 4.|All participants who received at least 1 dose of study medication were included in the safety analyses and listings.|||participant|||Number
2586394|NCT02334800|Secondary|Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Increase From Baseline)|Maximum increases from baseline for post baseline electrocardiogram values were summarized for PR interval, QRS complex, QT interval, QTcB (QT interval calculated using Bazett's correction factor), and QTcF (QT interval calculated using Fridericia's correction factor). The number of participants with maximum increase from baseline for post baseline electrocardiogram values meeting the following criteria was reported: (1) percent change of PR interval >=25/50%; (2) percent change of QRS complex >=50%; (3) QT interval 30 to <60 msec; (4) QT interval >= 60 msec; (5) QTcB 30 to <60 msec; (6) QTcB >= 60 msec; (7) QTcF 30 to <60 msec; and (8) QTcF >= 60 msec. Seven (7) participants in each cohort were evaluated for electrocardiogram tests except that 6 participants in the moderate hepatic impairment cohort (Cohort 3) were evaluated for PR interval.|Baseline up to Day 6 for Cohort 1 and to Day 9 for Cohorts 2, 3, and 4, not including baseline values.|All participants who received at least 1 dose of study medication were included in the safety analyses and listings. Seven (7) participants in each cohort were evaluated for electrocardiogram tests except that 6 participants in the moderate hepatic impairment cohort (Cohort 3) were evaluated for PR interval.|||paticipant|||Number
2586395|NCT02334800|Secondary|Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Absolute Values)|Maximum absolute values of post baseline electrocardiogram were summarized for PR interval, QRS complex, QT interval, QTcB (QT interval calculated using Bazett's correction factor), and QTcF (QT interval calculated using Fridericia's correction factor). The number of participants with maximum absolute values of post baseline electrocardiogram meeting the following criteria was reported: (1) PR interval >=300 msec; (2) QRS complex >=140 msec; (3) QT interval 450 to <480 msec; (4) QT interval 480 to <500 msec; (5) QT interval >= 500 msec; (6) QTcB 450 to <480 msec; (7) QTcB 480 to <500 msec; (8) QTcB >= 500 msec; (9) QTcF 450 to <480 msec; (10) QTcF 480 to <500 msec; and (11) QTcF >=500 msec. Seven (7) participants in each cohort were evaluated for electrocardiogram tests except that 6 participants in the moderate hepatic impairment cohort (Cohort 3) were evaluated for PR interval.|Baseline up to Day 6 for Cohort 1 and to Day 9 for Cohorts 2, 3, and 4, not including baseline values.|All participants who received at least 1 dose of study medication were included in the safety analyses and listings. Seven (7) participants in each cohort were evaluated for electrocardiogram tests except that 6 participants in the moderate hepatic impairment cohort (Cohort 3) were evaluated for PR interval.|||participant|||Number
2586396|NCT02334800|Secondary|Number of Participants With Post Baseline Vital Signs Values Meeting Categorical Summarization Criteria|The number of participants with post baseline vital signs values meeting the following criteria was reported: A. absolute value of supine systolic blood pressure less than (<) 90 mmHg; B. absolute value of diastolic blood pressure <50 mmHg; C. absolute value of supine pulse rate <40 bmp; D. absolute value of supine pulse rate larger than (>) 120 bmp; E. maximum increase from baseline in supine systolic blood pressure larger than and equal to (>=) 30 mmHg; F. maximum increase from baseline in supine diastolic blood pressure >=20 mmHg; G. maximum decrease from baseline in supine systolic blood pressure >=30 mmHg; and H. maximum decrease from baseline in supine diastolic blood pressure >=20 mmHg.|Baseline up to Day 6 for Cohort 1 and to Day 9 for Cohorts 2, 3, and 4, not including baseline values.|All participants who received at least 1 dose of study medication were included in the safety analyses and listings.|||participant|||Number
2586438|NCT02334306|Secondary|Ratio to Baseline in Minor Salivary Gland Tissue Biomarkers at Day 99|The minor salivary gland biopsy biomarkers included total plasma cell levels, CD4/ inducible T-cell costimulator (ICOS) TFH cells, and PD-1/ICOS TFH cells. Adjusted geometric mean ratio to baseline and standard error (log) are presented.|Baseline (Day 1 predose) and Day 99|The ITT population included all randomized and treated participants, grouped according to assigned treatment.|||Ratio||Standard Error|Geometric Mean
2586397|NCT02334800|Secondary|Number of Participants With Physical Examination Test Abnormalities (Change From Prior Visit)|A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The limited or abbreviated physical examination was focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Baseline up to Day 6 for Cohort 1 and to Day 9 for Cohorts 2, 3, and 4.|All participants who received at least 1 dose of study medication were included in the safety analyses and listings.|||participant|||Number
2586398|NCT02334800|Secondary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)|Laboratory tests included tests that were performed under the categories of hematology, chemistry, urinalysis, other, and additional tests needed for Hy's law.|Baseline up to Day 6 for Cohort 1 and to Day 9 for Cohorts 2, 3, and 4, inclusive of baseline values.|All participants who received at least 1 dose of study medication were included in the safety analyses and listings.|||participants|||Number
2586399|NCT02334800|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events|A serious adverse event is any untoward medical occurrence at any dose that resulted in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; or results in congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity are counted as treatment emergent. Relatedness to palbociclib is assessed by the investigator (Yes/No).|The active reporting period for serious adverse events began from the time that the participant provided informed consent through and including 28 calendar days after the last administration of palbociclib.|All participants who received at least 1 dose of study medication were included in the safety analyses and listings.|||participant|||Number
2586400|NCT02334800|Secondary|Number of Participants With Treatment Emergent Adverse Events|An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any events occurring following start of treatment or increasing in severity are counted as treatment emergent. Relatedness to palbociclib is assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|Adverse events were recorded on the Case Report Form from the time the participant had taken at least 1 dose of palbociclib through the participant's last visit.|All participants who received at least 1 dose of study medication were included in the safety analyses and listings.|||participant|||Number
2586401|NCT02334800|Secondary|Unbound Vz/F (Vz,u/F)|Vz,u/F is unbound Vz/F, where Vz/F is apparent volume of distribution after oral dose. It is obtained by dose/(AUCinf,u*kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve, and AUCinf,u is unbound AUCinf (area under the concentration-time curve from time 0 extrapolated to infinite time).|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||L||Geometric Coefficient of Variation|Geometric Mean
2586402|NCT02334800|Secondary|Apparent Volunm of Distribution After Oral Dose (Vz/F)|Vz/F is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. It is influenced by the fraction absorbed. It is obtained by dose/(AUCinf•kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve, and AUCinf is the area under the concentration-time curve from time 0 extrapolated to infinite time.|pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||liter (L)||Geometric Coefficient of Variation|Geometric Mean
2586403|NCT02334800|Secondary|Time for Cmax (Tmax)|Tmax is time for maximum plasma concentration. It is observed directly from data as time of first occurrence of maximum plasma concentration.|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics concentration population was defined as all participants enrolled and treated who had at least 1 palbociclib concentration|||hr||Full Range|Median
2586404|NCT02334800|Secondary|Terminal Half-Life (t1/2)|T1/2 is terminal half-life. It is obtained by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||hour (hr)||Standard Deviation|Mean
2586405|NCT02334800|Secondary|Fraction of Unbound Drug in Plasma (fu)|Fu is the fraction of unbound drug in plasma. It is obtained from measurement of protein binding.|Eight (8) hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||ratio||Standard Deviation|Mean
2586406|NCT02334800|Secondary|Unbound Cmax (Cmax,u)|Cmax,u is unbound Cmax, where Cmax is maximum plasma concentration. It is obtained by fu*Cmax, where fu is fraction of unbound drug in plasma.|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2587436|NCT02318940|Secondary|Successful Installation|Percentage of participants with successful installation of guide without difficulty in the femoral vein|intraoperative, an average of 1 hour||||percentage of participants|||Number
2586407|NCT02334800|Secondary|Unbound CL/F (CLu/F)|CLu/F is unbound CL/F, where CL/F is apparent clearance after oral dose. It is obtained by dose/AUCinf,u, where AUCinf,u is unbound AUCinf (area under the concentration-time curve from time 0 extrapolated to infinite time).|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2586408|NCT02334800|Secondary|Apparent Clearance After Oral Dose(CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance is obtained by dose/AUCinf, where AUCinf is the area under the concentration-time curve from time 0 extrapolated to infinite time.|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||liter/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2586409|NCT02334800|Secondary|Unbound AUClast (AUClast,u)|AUClast,u is unbound AUClast, where AUClast is area under the concentration-time curve from time 0 to the time of the last quantifiable concentration. It is obtained by fu*AUClast, where fu is the fraction of unbound drug in plasma.|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2586410|NCT02334800|Secondary|Area Under the Concentration‑Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)|AUClast is area under the plasma concentration time curve from time 0 to time of last quantifiable concentration. It is obtained from linear/log trapezoidal method.|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2586411|NCT02334800|Secondary|Unbound AUCinf (AUCinf,u)|AUCinf,u is unbound AUCinf, where AUCinf is area under the concentration-time curve from time 0 extrapolated to infinite time. It is obtained by fu*AUCinf, where fu is the fraction of unbound drug in plasma.|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2586412|NCT02334800|Primary|Maximum Plasma Concentration (Cmax)|Cmax is maximum plasma concentration. It is observed directly from data.|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics concentration population was defined as all participants enrolled and treated who had at least 1 palbociclib concentration.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2586413|NCT02334800|Primary|Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf)|AUCinf is area under the plasma concentration time curve from time 0 extrapolated infinite time. It is calculated as AUClast + (Clast/kel), where AUClast is area under the concentration-time curve from time 0 to the time of the last quantifiable concentration, Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.|The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2586414|NCT02334787|Secondary|AUC12h of OPA-15406 in the Multiple Administration Period|We measure the plasma concentration of OPA-15406 from Day 1 to Day 14 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as multiple doses twice daily for 2 weeks. We assess the AUC12h x of OPA-15406.|Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14||||ng･h/mL||Standard Deviation|Mean
2586415|NCT02334787|Secondary|AUC12h of OPA-15406 in a Single Administration Period|We measure the plasma concentration of OPA-15406 at Day 1 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as a single dose. We assess the AUC12h x of OPA-15406.|Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs||||ng･h/mL||Standard Deviation|Mean
2586416|NCT02334787|Primary|Cmax of OPA-15406 in the Multiple Administration Period|We measure the plasma concentration of OPA-15406 from Day 1 to Day 14 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as multiple doses twice daily for 2 weeks. We assess the AUC12h x of OPA-15406.|Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hrs at Day 14||||ng/mL||Standard Deviation|Mean
2586417|NCT02334787|Primary|Cmax of OPA-15406 in a Single Administration Period|We measure the plasma concentration of OPA-15406 at Day 1 by applying 0.3%, 1%, or 3% formulation of OPA-15406 ointment as a single dose. We assess the Cmax of OPA-15406.|Baseline, 2 ,3, 4, 8, 10, 12, 16, 24 and 48 hr||||ng/mL||Standard Deviation|Mean
2586464|NCT02333045|Secondary|Steady-state Area Under the Female Genital Tract Concentration-time Curve of Study Drug|Study drug concentrations will be measured from female genital tract.|7 days|Data were not collected at each visit as some participants declined providing samples. Due to the small number of observations, study drug concentrations were not determined for the samples provided.||||||
2586418|NCT02334527|Secondary|Number of Participants With Adverse Events|Characterize the safety profile of palbociclib in patients with metastatic UC after first-line chemotherapy. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.|30 Days||||Participants|||Count of Participants
2586419|NCT02334527|Secondary|Response Rate (RR) - Total Number of Patients With Complete Response (CR) and/or Partial Response (PR)|Estimate response rate (RR) in patients with metastatic UC who have progressed after first-line chemotherapy. Response rate will be the number of patients with complete response and/or partial response. Response will be based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Radiographic response will be measured by RECIST, Response Evaluation Criteria In Solid Tumors Criteria, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|4 Months||||Participants|||Count of Participants
2586420|NCT02334527|Secondary|Overall Survival (OS)|Overall survival is defined as the time from day 1 of treatment until death as a result of any cause.|Patients will be followed for up to 5 years after removal from study therapy or death, whichever occurs first.||||Months||95% Confidence Interval|Median
2586421|NCT02334527|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from D1 of treatment until progression or death as a result of any cause. Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|4 Months||||Months||95% Confidence Interval|Median
2586422|NCT02334527|Primary|Progression Free Survival|Estimate progression free survival (PFS) at 4 months in patients with metastatic urothelial cancer (UC) who have progressed after first-line chemotherapy. PFS is defined as the percent of patients who are alive and free from progression at 4 months.|4 Months||||Participants|||Count of Participants
2586423|NCT02334436|Secondary|Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject|"Secondary endpoint was the proportion of subjects classified as responders on Day 150. This was a composite endpoint based on both the Investigator and subject assessments of glabellar lines at maximum frown on the GLS; a subject was a responder only if both the Investigator and subject independently agreed that a ≥2 point improvement had occurred from Day 0 to 150 Day~GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe."|Day 150|Intent-to-treat|||percentage of responders||95% Confidence Interval|Number
2586424|NCT02334436|Secondary|Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject|"Secondary endpoint was the proportion of subjects classified as responders on Day 120. This was a composite endpoint based on both the Investigator and subject assessments of glabellar lines at maximum frown on the GLS; a subject was a responder only if both the Investigator and subject independently agreed that a ≥2 point improvement had occurred from Day 0 to 120 Day~GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe."|Day 120|Intent-to-treat|||percentage of responders||95% Confidence Interval|Number
2586425|NCT02334436|Secondary|Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject|"Secondary endpoint was the proportion of subjects classified as responders on Day 90. This was a composite endpoint based on both the Investigator and subject assessments of glabellar lines at maximum frown on the GLS; a subject was a responder only if both the Investigator and subject independently agreed that a ≥2 point improvement had occurred from Day 0 to 90 Day.~GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe."|90 Days|Intent-to-treat|||percentage of responders||95% Confidence Interval|Number
2586426|NCT02334436|Primary|Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject|"The primary efficacy end point assesses the effectiveness of DWP-450 against placebo on Day 30. The primary efficacy measure is a composite end point. Using the GLS scale, investigators and subjects will assess the glabellar lines at Day 0 and Day 30. A subject is a responder only if both the investigator and subject independently agree that a ≥2 improvement has occurred from Day 0 to Day 30.~GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe."|Day 30|Intent-to-treat|||percentage of responders||95% Confidence Interval|Number
2586427|NCT02334423|Secondary|Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject|"Secondary endpoint was the proportion of subjects classified as responders on Day 90. This was a composite endpoint based on both the Investigator and subject assessments of glabellar lines at maximum frown on the GLS; a subject was a responder only if both the Investigator and subject independently agreed that a ≥2 point improvement had occurred from Day 0 to 90 Day~GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe."|Day 90|Intent-to-Treat|||percentage of responders||95% Confidence Interval|Number
2586428|NCT02334423|Secondary|Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject|"Secondary endpoint was the proportion of subjects classified as responders on Day 150. This was a composite endpoint based on both the Investigator and subject assessments of glabellar lines at maximum frown on the GLS; a subject was a responder only if both the Investigator and subject independently agreed that a ≥2 point improvement had occurred from Day 0 to 150 Day~GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe."|Day 150|Intent-to-treat|||percentage of responders||95% Confidence Interval|Number
2586439|NCT02334306|Secondary|Ratio to Baseline in Peripheral Blood Biomarkers at Day 99|The peripheral blood biomarkers included total plasma cell levels (including plasma blast levels) and T follicular helper (TFH) cells. Adjusted geometric mean ratio to baseline and standard error (log) are presented.|Baseline (Day 1 predose) and Day 99|The ITT population included all randomized and treated participants, grouped according to assigned treatment.|||Ratio||Standard Error|Geometric Mean
2586429|NCT02334423|Secondary|Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject|"Secondary endpoint was the proportion of subjects classified as responders on Day 120. This was a composite endpoint based on both the Investigator and subject assessments of glabellar lines at maximum frown on the GLS; a subject was a responder only if both the Investigator and subject independently agreed that a ≥2 point improvement had occurred from Day 0 to 120 Day~GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe."|Day 120|Intent-to-treat|||percentage of responders||95% Confidence Interval|Number
2586430|NCT02334423|Primary|Percentage of Participants With a ≥2 Point Improvement in Glabellar Line Scale (GLS) as Independently Assessed by Investigator and and Subject|"The primary efficacy end point assesses the effectiveness of DWP-450 against placebo on Day 30. The primary efficacy measure is a composite end point. Using the GLS scale, investigators and subjects will assess the glabellar lines at Day 0 and Day 30. A subject is a responder only if both the investigator and subject independently agree that a ≥2 improvement has occurred from Day 0 to Day 30.~GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe."|Day 30|c|||percentage of responders||95% Confidence Interval|Number
2586431|NCT02334384|Primary|Number of Side-effects|Evaluate for evidence of side-effects from Antimicrobial TheraGauze packing of skin abscess wounds compared with standard of care (i.e. cotton wick or iodoform wick). Tests for statistical significance will be made for multiple potential side-effects including: 1) erythema around the wound packing, 2) increased pain at the wound site, 3) increased tenderness around the wound 4) increased discharge from the wound, 4) new rash, and 5) fever.|1 week||||Participants|||Count of Participants
2586432|NCT02334358|Primary|Incidence of Device-related Adverse Events||Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.||||Participants|||Count of Participants
2586433|NCT02334306|Secondary|Number of Participants With Adverse Events of Special Interest (AESIs)|An AESI (serious or non-serious) was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor. The AESIs for this study were hepatic function abnormality meeting the definition of Hy's law, new or reactivated tuberculosis infection, malignancy, and hypersensitivity and anaphylactic reactions. Treatment-emergent AESIs were collected from Day 1 (postdose) until Day 99 for 'Placebo' arm and Day 296 for 'Any MEDI5872 210 mg' arm.|Placebo arm: Day 1 (postdose) through Day 99 (predose); Any MEDI5872 210 mg arm: Day 1 (postdose) through Day 296 for MEDI5872 210 mg arm, and Day 99 (postdose) through Day 296 for participants who received placebo at double-blind period|"Placebo: As-treated population (participants grouped per actual treatment received).~Any MEDI5872 210 mg: Any MEDI5872 population (participants received at least 1 dose of MEDI5872 either in double-blind and/or open-label). 1 participant from ‘Placebo’ discontinued treatment before Day 99 and didn’t receive MEDI5872 dose in open-label period."|||Participants|||Count of Participants
2586434|NCT02334306|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were collected from Day 1 (postdose) until Day 99 for 'Placebo' arm and Day 296 for 'Any MEDI5872 210 mg' arm that were absent before treatment or that worsened relative to pre-treatment state.|Placebo arm: Day 1 (postdose) through Day 99 (predose); Any MEDI5872 210 mg arm: Day 1 (postdose) through Day 296 for MEDI5872 210 mg arm, and Day 99 (postdose) through Day 296 for participants who received placebo at double-blind period|"Placebo: As-treated population (participants grouped per actual treatment received).~Any MEDI5872 210 mg: Any MEDI5872 population (participants received at least 1 dose of MEDI5872 either in double-blind and/or open-label). 1 participant from ‘Placebo’ discontinued treatment before Day 99 and didn’t receive MEDI5872 dose in open-label period."|||Participants|||Count of Participants
2586435|NCT02334306|Secondary|Percentage of ESSDAI Responders at Day 99|The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of 12 organ-specific domains (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, and biological). Each domain is assessed for activity level in 3 or 4 levels (no, low, moderate, high) according to their severity (0=no disease activity and ¾ = high disease activity of the domain). Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 [best] to 123 [worst activity]). Participants are considered to be an ESSDAI[x] responder as they achieved a reduction of x points or more in ESSDAI score, did not prematurely discontinue the study drug, and did not receive prohibited concomitant medications.|Baseline (Day 1 predose) and Day 99|The ITT population included all randomized and treated participants, grouped according to assigned treatment.|||Percentage of participants|||Number
2586436|NCT02334306|Secondary|Change From Baseline in European League Against Rheumatism Sjogren's Syndrome Patient Reported Index (ESSPRI) Score at Day 99|The European League Against Rheumatism Sjogren's Syndrome Patient Reported Index (ESSPRI) is a patient-reported, subjective symptom index for primary Sjögren's syndrome. It consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Adjusted mean change and standard error are presented.|Baseline (Day 1 predose) and Day 99|The ITT population included all randomized and treated participants, grouped according to assigned treatment.|||Scores on a scale||Standard Error|Mean
2586437|NCT02334306|Secondary|Ratio to Baseline in Focus Score at Day 99|The focus score is a semi-quantitative assessment of focal lymphocytic sialoadenitis, which is defined as the presence of >= 1 dense aggregate of 50 or more lymphocytes in a 4 mm2 area. Higher numbers are associated with more inflammation.|Baseline (Day 1 predose) and Day 99|The ITT population included all randomized and treated participants, grouped according to assigned treatment. The “Overall Number of Participants Analyzed” denotes the number of participants evaluated for this outcome measure.|||Ratio||Standard Deviation|Mean
2586440|NCT02334306|Primary|Change From Baseline in European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) Score at Day 99|The European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ESSDAI) is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of 12 organ-specific domains (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, and biological). Each domain is assessed for activity level in 3 or 4 levels (i.e., no, low, moderate, high) according to their severity (no disease activity equals to 0 and for high disease activity the domain score equals 3 or 4). Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). A higher score indicates worsening of the disease. Adjusted mean change and standard error are presented.|Baseline (Day 1 predose) and Day 99|"Intent-to-treat (ITT) population included all randomized and treated participants, grouped according to assigned treatment. The Overall Number of Participants Analyzed” denotes the number of participants evaluated for this outcome measure."|||Scores on a scale||Standard Error|Mean
2586441|NCT02334267|Primary|Peridialytic Venous Blood Acetate Concentrations|Quantification of Peridialytic Venous Blood Acetate Concentrations|25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis|Per Protocol Population|||mmol/L||Standard Deviation|Mean
2586442|NCT02334267|Primary|Peridialytic Arterialized Blood Acetate Concentrations|Quantification of Peridialytic Arterialized Blood Acetate Concentrations|Immediately prior to initiation of hemodialysis, and 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis and 15, 30, 45, 60, 75, and 90 minutes post hemodialysis|Per Protocol Population|||mmol/L||Standard Deviation|Mean
2586443|NCT02334267|Primary|Peridialytic Venous Blood Bicarbonate Concentrations|Quantification of Peridialytic Venous Blood Bicarbonate Concentrations|25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis|Per Protocol Population|||mEq/l||Standard Deviation|Mean
2586444|NCT02334267|Primary|Peridialytic Arterialized Blood Bicarbonate Concentrations|Quantification of Peridialytic Arterialized Blood Bicarbonate Concentrations|Immediately prior to initiation of hemodialysis, and 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis and 15, 30, 45, 60, 75, and 90 minutes post hemodialysis|Per Protocol Population|||mEq/l||Standard Deviation|Mean
2586445|NCT02334059|Secondary|Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane|The average MAC concentration of desflurane will be recorded during the intraoperative period. The Minimum Alveolar Concentration (MAC) of an inhaled anesthetic is the alveolar (or end-expiratory) concentration at which 50% of patients will not show a motor response to a standardized surgical incision.|Intraoperative period|Intraoperative period: Intraoperative Minimum Alveolar Concentration (MAC) of desflurane|||Minimal Alveolar Concentration (MAC)||95% Confidence Interval|Mean
2586446|NCT02334059|Secondary|Pain Scores Using Visual Analogue Scale (VAS)|Pain scores using VAS scale will be recorded pre-operatively, in the PACU, and every 4 hours until 24 hours post-op. The VAS is a 10 point scale, where 0 = no pain and 10 = the worst pain a subject has ever felt. The highest value 10, indicates an extreme self reported level of pain.|Preoperatively and the 1st 24 hours post-op||||units on a scale||95% Confidence Interval|Mean
2586447|NCT02334059|Primary|Total Hydromorphone Use|Total hydromorphone use in 1st 24 hours post-operatively.|During surgery and 24 hours post-op||||mcg/Kg||95% Confidence Interval|Mean
2586448|NCT02333630|Secondary|Frequency of Use of the Mobile Health Application|Analytics from within the mobile application will be measured to determine the frequency and usage patterns of the mobile health application by users during the study period|6 months|Data were not collected for this measure||||||
2586449|NCT02333630|Secondary|Hospitalizations|Number of hospitalizations for asthma exacerbation during 6 month study duration|6 months||||visits||Standard Deviation|Mean
2586450|NCT02333630|Secondary|Number of Asthma Exacerbations|Number of prednisone courses prescribed for asthma exacerbations during 6 month study time frame|6 months|Data were not collected for this outcome measure||||||
2586451|NCT02333630|Primary|Number of Emergency Room Visits Secondary to Asthma Exacerbation|Number of emergency room visits for asthma 6 months following study enrollment and randomization|6 months||||visits||Standard Deviation|Mean
2586452|NCT02333383|Secondary|Mean Change in Change in Swollen Joint Counts (SJC) in Participants With Peripheral Arthritis (≥1 Swollen Joint) at Baseline|Forty-four joints, excluding hip joints, were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score SJC of 0 (0 joints with swelling) to 44 (worst possible score/44 joints with swelling). Negative values indicate improvement from baseline.|Baseline, Week 12, Week 28, Week 36, Week 52|Intention-to-Treat (ITT) population: Participants with available data who received at least one dose of adalimumab and had peripheral arthritis (≥1 swollen joint) at baseline|||Swollen joint counts||Standard Deviation|Mean
2586453|NCT02333383|Secondary|Mean Change in Tender Joint Counts (TJC) in Participants With Peripheral Arthritis (≥1 Swollen Joint) at Baseline|Forty-six joints were assessed for tenderness by physical examination. Tenderness of each joint was classified as present (1) or absent (0), for a total possible TJC score of 0 (0 joints with tenderness) to 46 (worst possible score/46 joints with tenderness). Negative values indicate improvement from baseline.|Baseline, Week 12, Week 28, Week 36, Week 52|Intention-to-Treat (ITT) population: Participants with available data who received at least one dose of adalimumab and had peripheral arthritis (≥1 swollen joint) at baseline|||Tender joint counts||Standard Deviation|Mean
2586454|NCT02333383|Secondary|Mean Change in Dactylitis Score in Participants With Dactylitis at Baseline|Assessment of the presence or absence of dactylitis (inflammation of finger and/or toe joints) as well as grading of tenderness and swelling in all 20 of the participants' digits was performed. Tenderness at each site was quantified from absent to severe. Swelling was quantified from mild to severe. Total Dactylitis Assessment scores ranged from 0 (no digits with dactylitis) to 20 (worst possible score; 20 digits with dactylitis). Negative values indicate improvement from baseline.|Baseline, Week 12, Week 28, Week 36, Week 52|Intention-to-Treat (ITT) population: Participants with available data who received at least one dose of adalimumab and had dactylitis at baseline|||units on a scale||Standard Deviation|Mean
2586840|NCT02327169|Primary|Recommended Phase 2 Dose (RP2D) of MLN2480||Day 1, Cycle 1 up to 28 days|The DLT-evaluable population was defined as all participants in the dose escalation phase of the study who either experienced DLT during cycle 1, or completed at least 75% of the scheduled doses in cycle 1 without DLT.|||mg|||Number
2586455|NCT02333383|Secondary|Proportion of Participants With Enthesitis of the Plantar Fascia|The plantar fascia is a ligament that runs along the bottom of each foot. The percentage of participants who had enthesitis of the plantar fascia was documented at each study visit.|Baseline, Week 12, Week 28, Week 36, Week 52|Intention-to-Treat (ITT) population: Participants with available data who received at least one dose of adalimumab and had extra-axial manifestations (EAMs) assessed at baseline|||Participants|||Count of Participants
2586456|NCT02333383|Secondary|Mean Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Participants With Enthesitis at Baseline|Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Each domain was graded for the presence (1) or absence (0) of tenderness yielding total MASES ranging from 0 (0 sites with tenderness) to 13 (worst possible score; 13 sites with tenderness). Negative values indicate improvement from baseline.|Baseline, Week 12, Week 28, Week 36, Week 52|Intention-to-Treat (ITT) population: Participants with available data who received at least one dose of adalimumab and had enthesitis at baseline|||units on a scale||Standard Deviation|Mean
2586457|NCT02333383|Secondary|Proportion of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response|The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity. BASDAI 50 is a 50% improvement from baseline in BASDAI score.|Baseline, Week 12, Week 28, Week 36, Week 52|Intention-to-Treat (ITT) population: Participants with available data who received at least one dose of adalimumab and had extra-axial manifestations (EAMs) assessed at baseline|||Participants|||Count of Participants
2586458|NCT02333383|Primary|Frequency of Extra-Axial Manifestations (EAMs) of Interest|The baseline assessment was performed prior to the first dose of adalimumab. The presence of peripheral arthritis (arthritis affecting shoulders, elbows, wrists, hands, knees, ankles, feet), enthesitis (inflammation of the areas where ligaments or tendons insert into bone) and dactylitis (inflammation of finger and/or toe joints) was noted. Peripheral arthritis was defined as ≥1 swollen joint on the Swollen Joint Count scale (SJC; range, 0 to 44, excluding hip joints). Enthesitis was defined as at least one inflamed enthesis in the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES, 0 to 13, with higher scores representing more severe disease) or of the plantar fascia of the foot. Dactylitis was measured by a simple count of dactylitic digits.|Baseline|Intention-to-Treat (ITT) population: Participants who received at least one dose of adalimumab and had extra-axial manifestations (EAMs) assessed at baseline|||Percentage of participants||95% Confidence Interval|Number
2586459|NCT02333331|Secondary|Percentage Change From Baseline to Week 25 on Total Lean Body Mass Measured by Dual Energy X-ray Absorptiometry (DXA)|Change from Baseline to Week 25 on Total lean body mass and appendicular skeletal muscle index (ASMI) measured by Dual Energy X-ray Absorptiometry (DXA) total lean body mass (LBM) is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(LBM at Visit - LBM at Baseline) / LBM at Baseline] * 100.|baseline, week 25|Full Analysis Set (FAS) -comprised all patients to whom study treatment had been assigned. Following the intent to treat principle, patients were analyzed according to treatment assigned at randomization.|||Percent Change||Standard Deviation|Mean
2586460|NCT02333331|Secondary|Percentage Change From Baseline to Week 25 on Appendicular Skeletal Muscle Index (ASMI) Measured by Dual Energy X-ray Absorptiometry (DXA)|Change from Baseline to Week 25 on appendicular skeletal muscle index (ASMI) measured by Dual Energy X-ray Absorptiometry (DXA) Appendicular skeletal muscle index (ASMI) is a core requirement for determining the presence of sarcopenia and is calculated as the sum of the appendicular lean mass (kg) of the two upper and two lower limbs quantified by DXA, divided by height (m^2). Therefore, an increase in ASMI indicates an increase in the quantity of an individual's lean mass.|baseline, week 25|Full Analysis Set (FAS) -comprised all patients to whom study treatment had been assigned. Following the intent to treat principle, patients were analyzed according to treatment assigned at randomization.|||Percent Change||Standard Deviation|Mean
2586461|NCT02333331|Secondary|Change From Baseline to Week 25 in Usual Gait Speed (GS) Over 4 Meters|Change from Baseline to Week 25 in usual Gait speed (GS) over 4 meters Gait speed in this study was assessed as part of the SPPB, over a 4 meter distance of a 6 meter course. This test assessed a person's usual walking speed, which was defined as the speed a person normally walks from one place to another without urgency (e.g., walking down a hallway).|baseline, week 25|Full Analysis Set (FAS) -comprised all patients to whom study treatment had been assigned. Following the intent to treat principle, patients were analyzed according to treatment assigned at randomization.|||m/sec||Standard Deviation|Mean
2586462|NCT02333331|Secondary|Change From Baseline at Week 25 in the 6 Minute Walk Test (6MWT) Distance|Change from Baseline at Week 25 in the 6 minute walk test (6MWT) distance to measure improvement in physical function|Baseline, week 25|Full Analysis Set (FAS) -comprised all patients to whom study treatment had been assigned. Following the intent to treat principle, patients were analyzed according to treatment assigned at randomization.|||meters||Standard Deviation|Mean
2586463|NCT02333331|Primary|Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25|Change from Baseline in total Short Physical Performance Battery (SPPB) Score to week 25; SPPB is a series of six activities involving three domains of physical function - balance, usual walking speed and rising from a chair , is commonly used globally to assess and quantify (score 0-12) lower extremity function and has been shown to predict future adverse health events. A decline of one or more points in the SPPB total score is predictive of a decrease in lower extremity function and future adverse clinical outcomes in older adults, including falls, hospitalizations, institutionalization, incident disability and death|Baseline, week 25|Full Analysis Set (FAS) -comprised all patients to whom study treatment had been assigned. Following the intent to treat principle, patients were analyzed according to treatment assigned at randomization.|||Score on a scale||Standard Deviation|Mean
2586465|NCT02333045|Secondary|Steady-state Area Under the Plasma Concentration-time Curve of Study Drug|Study drug concentrations will be measured from blood.|7 days|Data were not collected at each visit as some participants declined providing samples. Due to the small number of observations, study drug concentrations were not determined for the samples provided.||||||
2586466|NCT02333045|Primary|Count of Total Cells Obtained From Cervicovaginal Lavage Samples|The count of CCR5+CD4+ T cells in the genital tract, before participants began study treatment, after 7 days of treatment, and during the post-treatment drug elimination period. The precise role of CCR5+CD4+ T cells in the female genital tract is unknown, however, higher cell counts may suggest the potential for more HIV target cells in the genital tract.|Baseline, Day 7, Day 14, Day 21|The analysis includes all available data collected during each study visit. Not all participants provided a sample at every study visit.|||cells||Standard Deviation|Mean
2586467|NCT02332902|Other Pre-specified|Determine How Orally Administered Everolimus Effects mTOR Signaling in NF-1 Tissues|Quantification via immunohistochemical staining of PTEN, pS6, p4EBP-1, TSC2, mTOR, NF-1, pAKT, VEGF-A and IGF-IR expression in biopsied neurofibroma tissue samples.|6 months|||||||
2586468|NCT02332902|Secondary|Number of Participants With Grade 3-4 Adverse Events|Determination if orally administered Afinitor is safe in patients a indicated by lack of Grade 3-4 adverse events during the trial period.|6 months||||Participants|||Count of Participants
2586469|NCT02332902|Primary|3D Photographic Measurement of Surface Volume|Photographs of selected lesions to measure surface volume.|6 months||||mm^3||95% Confidence Interval|Mean
2586470|NCT02332889|Primary|Tolerability (Number of Participants Without Adverse Events)||20 weeks||||Participants|||Count of Participants
2586471|NCT02332876|Primary|National Institutes of Health Toolbox - Cognition Domain- Oral Symbol Digit Test|Change in score on the NIH Toolbox Oral Symbol Digit test, an objective measure of processing speed, from baseline to 12 weeks. The Oral Symbol Digit test provides a raw score (possible range is 0-144). A higher score indicates better processing speed.|Baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
2586472|NCT02332824|Other Pre-specified|Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to Week 14|Safety analysis set included all participants who received at least one dose of the study drug for the treatment period.|||Participants|||Count of Participants
2586473|NCT02332824|Secondary|Progression Rate From Early-Stage Nephropathy (Stage 2) to Overt Nephropathy (Stage 3) During the Treatment Period (Week 12)|Progression rate is defined as percentage of participants who have UACR ≥300 mg/gCr and whose UACR increased by ≥30% from the value at the end of the pre-treatment period [Week 0]. Meanwhile, the definition of transition to overt nephropathy also includes the case that UACR decreased to <300 mg/gCr after the transition to overt nephropathy.|Week 12|The FAS included all participants who were randomized and received at least one dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2586474|NCT02332824|Secondary|Remission Rate From Early-Stage Nephropathy (Stage 2) to Pre-Nephropathy Stage (Stage 1) at the End of Treatment (Week 12)|Remission rate is defined as percentage of participants who have UACR <30 mg/gCr and whose UACR decreased by ≥30% from the value at the end of the pre-treatment period (Week 0).|Week 12|The FAS included all participants who were randomized and received at least one dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2586475|NCT02332824|Secondary|Urine Albumin/Creatinine Ratio (UACR) at Each Assessment Point|The first morning void urine (the first urine immediately after rising prior to activities in standing position in the morning) samples on the day of each visit, and 1 day and 2 days before the day of each visit (3 consecutive days) were collected to calculate UACR. Reported data is geometric mean ratio of UACR at each assessment point relative to Baseline.|Weeks 2, 4, 8, 12, follow-up (Week 14) and End of Treatment|The FAS included all participants who were randomized and received at least one dose of the study drug for the treatment period. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at particular timepoint.|||mg/gCr||95% Confidence Interval|Geometric Mean
2586476|NCT02332824|Primary|Change From End of Pre-treatment Period (Week 0) in Log-transformed Urine Albumin/Creatinine Ratio (UACR) at the End of Treatment Period (Week 12)|The first morning void urine (the first urine immediately after rising prior to activities in standing position in the morning) samples on the day of each visit, and 1 day and 2 days before the day of each visit (3 consecutive days) were collected to calculate UACR.|Week 0 and Week 12|Full analysis set (FAS) included all participants who were randomized and received at least one dose of the study drug for the treatment period. Here number of participants analyzed are participants evaluable for this outcome measure.|||log (mg/gCr)||95% Confidence Interval|Least Squares Mean
2586477|NCT02332798|Primary|Number of Participants With Positive Response to Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced the following: completed suicide (1), suicide attempt (2) (response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (3)(Yes on preparatory acts or behavior), suicidal ideation (4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(Yes on Has participant engaged in non-suicidal self-injurious behavior)."|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
2586602|NCT02330549|Secondary|Change From Baseline in Liver Transaminase: Alanine Aminotransferase (ALT)|Blood was collected and was sent to a central laboratory for analysis of ALT. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline to Weeks 12 and 24|Safety Population included all participants who received at least one dose of study drug. Number analyzed were the participants with analysis values at specified time point.|||U/L||Standard Deviation|Mean
2586478|NCT02332798|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last study drug administration|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
2586479|NCT02332798|Primary|Number of Participants With Abnormalities in Physical Examination|A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
2586480|NCT02332798|Primary|Number of Participants With Abnormalities in Neurological Examination|The extended neurological examination, performed by a board certified neurologist, included observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger, nose, heel, shin, Romberg, tandem walking, positional and gaze evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination included an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function were complemented by the Scale for Assessment and Rating of Ataxia (SARA).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
2586481|NCT02332798|Primary|Number of Participants With Electrocardiogram Data Meeting Criteria of Potential Clinical Concern|Electrocardiogram (ECG) parameters included beginning of the P wave until the beginning of the QRS complex (PR) interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) interval, and QTc using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to (=<)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); and and QTcF >=450 to <480, 480 to <500 and >=500 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
2586482|NCT02332798|Primary|Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate less than (<) 40 or greater than (>) 120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture or DBP <50 mm Hg. IFB = increase from baseline; DFB = decrease from baseline.|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
2586483|NCT02332798|Primary|Number of Participants With Abnormal Clinical Laboratory Measurements|The following laboratory parameters were reported: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, phosphorus, cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), bicarbonate, uric acid, albumin, and total protein); urinalysis (color, appearance, specific gravity, pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, and microscopy); others (follicle stimulating hormone [FSH], and urine drug screening).|Baseline up to Day 21|The safety analysis population included all participants who received at least 1 dose of the study medication.|||participants|||Number
2586484|NCT02332798|Primary|Peak-to-Trough Ratio at Steady State (PTR)|PTR was calculated as Cmax divided by Cmin (that is defined as lowest concentration observed during the dosing interval). PTR steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2586485|NCT02332798|Primary|Observed Accumulation Ratio for Cmax (Rac, Cmax) (Steady State)|Accumulation ratio based on Cmax was calculated as: Rac,Cmax = Cmax at steady state (ss) divided by Cmax at first dose. Rac, Cmax steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2586486|NCT02332798|Primary|Observed Accumulation Ratio (Rac) (Steady State)|Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from time 0-t (Day X) divided by AUC from time 0-t (Day 1). Rac steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 (ie. X = 14) were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2587354|NCT02319967|Secondary|Number of Participants With All-cause Emergency Department (ED) or Urgent Care Visits|Count of participants (children) with at least one all-cause ED or urgent care visit at 6 months|6 months post index ED discharge||||Participants|||Count of Participants
2586487|NCT02332798|Primary|Terminal Half-Life (t1/2) (Steady State)|Terminal half-life is the time measured for the plasma concentration to decrease by one half. t1/2 steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||hours||Standard Deviation|Mean
2586488|NCT02332798|Primary|Apparent Volume of Distribution (Vz/F) (Steady State)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. Vz/F steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
2586489|NCT02332798|Primary|Apparent Oral Clearance (CL/F) (Steady State)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
2586490|NCT02332798|Primary|AUCτ (Steady State)|AUCτ steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2586491|NCT02332798|Primary|Area Under the Concentration-Time Profile From Time 0 to Time Tau (τ), the Dosing Interval, Where τ = 12 Hours (AUCτ) (Single Dose)||Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2586492|NCT02332798|Primary|Tmax (Steady State)|Tmax steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||hours||Full Range|Median
2586493|NCT02332798|Primary|Time for Cmax (Tmax) (Single Dose)||Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)|The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured.|||hours||Full Range|Median
2586494|NCT02332798|Primary|Cmax (Steady State)|Cmax steady state for PF-04958242 0.25 mg group and PF-04958242 0.475 mg group at Day 14 were presented.|Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21|The PK concentration population is defined as all enrolled subjects treated who received at least one dose of PF-04958242 and have at least 1 measureable concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2586495|NCT02332798|Primary|Maximum Observed Plasma Concentration (Cmax) (Single Dose)||Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose)|The pharmacokinetic (PK) concentration population is defined as all enrolled subjects treated who received at least one dose of PF-04958242 and have at least 1 measureable concentration.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2586496|NCT02332720|Secondary|Percentage of GT3-infected Participants Achieving SVR at Follow-up Week 24 (SVR24)|SVR24 is defined as HCV RNA <LLOQ of 15 IU/mL 24 weeks after the end of all study therapy. A4+B4: GT3 NC TN MK-3682B (8 weeks) arm includes both participants from Part A and Part B who received equivalent dose of MK-3682B.|Up to 40 weeks|Analysis population included HCV GT3 participants who received treatment and did not have major protocol deviations that may substantially affect the results of the SVR endpoints. Therefore, only GT3 treatment arms are presented in the table below.|||Percentage of participants||95% Confidence Interval|Number
2586497|NCT02332720|Primary|Number of Participants Who Had Study Drug Discontinued Due to an AE|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Part C in the table below combines all (eight) participants from the four distinct arms of Part A who relapsed and were subsequently treated with MK-3682B + RBV for 16 weeks.|Up to 16 weeks|All participants who received at least 1 dose of study drug, categorized according to the treatment actually received. A4+B4 arm includes both participants from Part A and Part B who received equivalent dose of MK-3682B. Part C arm includes participants who relapsed following the completion of Part A therapy and received treatment during Part C.|||Participants|||Count of Participants
2586603|NCT02330549|Secondary|Change From Baseline in Body Weight|A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24|Safety Population included all participants who received at least one dose of study drug. Number analyzed were the participants with analysis values at specified time point.|||kg||Standard Deviation|Mean
2586498|NCT02332720|Primary|Number of Participants Experiencing an Adverse Event (AE)|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Part C in the table below combines all (eight) participants from the four distinct arms of Part A who relapsed and were subsequently treated with MK-3682B + RBV for 16 weeks.|Up to 40 weeks|All participants who received at least 1 dose of study drug, categorized according to the treatment actually received. A4+B4 arm includes both participants from Part A and Part B who received equivalent dose of MK-3682B. Part C arm includes participants who relapsed following the completion of Part A therapy and received treatment during Part C.|||Participants|||Count of Participants
2586499|NCT02332720|Primary|Percentage of HCV GT3-infected Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 is defined as HCV ribonucleic acid (RNA) less than the lower limit of quantification (<LLOQ, 15 IU/mL) 12 weeks after the end of all study therapy. A4+B4: GT3 NC TN MK-3682B (8 weeks) arm includes both participants from Part A and Part B who received equivalent dose of MK-3682B.|Up to 20 weeks (Part A), up to 28 weeks (Part B)|Analysis population included HCV GT3 participants who received treatment and did not have major protocol deviations that may substantially affect the results of the SVR endpoints. Therefore, only GT3 treatment arms are presented in the table below.|||Percentage of participants||95% Confidence Interval|Number
2586500|NCT02332707|Primary|Percentage of Participants Discontinuing From Study Treatment Due to an AE|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 16 weeks|All randomized participants who received at least 1 dose of study drug are included.|||Percentage of Participants|||Number
2586501|NCT02332707|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Ending Study Treatment (SVR24)|The percentage of participants with HCV RNA < LLoQ 24 weeks after completing treatment (i.e., SVR24) in each arm was determined. Plasma levels of HCV RNA levels were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 assay, which has a LLoQ of 15 IU/mL.|Up to 40 weeks|All randomized participants who received at least 1 dose of study drug and had SVR24 results available are included.|||Percentage of Participants||95% Confidence Interval|Number
2586502|NCT02332707|Primary|Percentage of Participants Experiencing an Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 18 weeks|All randomized participants who received at least 1 dose of study drug are included.|||Percentage of Participants|||Number
2586503|NCT02332707|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Treatment (SVR12)|The percentage of participants with Hepatitis C virus (HCV) ribonucleic acid (RNA) < Lower Limit of Quantification (LLoQ) 12 weeks after completing treatment (i.e., SVR12) in each arm was determined. Plasma levels of HCV RNA levels were measured using the Roche COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 assay, which has a LLoQ of 15 IU/mL.|Up to 28 weeks|All randomized participants who received at least 1 dose of study drug and had SVR12 results available are included.|||Percentage of Participants||95% Confidence Interval|Number
2586504|NCT02332590|Secondary|Measurement of Anti-Drug Antibody (ADA) Levels||Over time, maximum to Week 306|||||||
2586505|NCT02332590|Secondary|Clinically Significant Changes in Vital Signs||Over time, maximum to Week 306|||||||
2586506|NCT02332590|Secondary|Clinically Significant Changes in ECG||Over time, maximum to Week 306|||||||
2586507|NCT02332590|Secondary|Clinically Significant Changes in Laboratory Values: Hematology, Clinical Chemistry, and Urinalysis||Over time, maximum to Week 306|||||||
2586508|NCT02332590|Secondary|Number of Participants With Adverse Events||Over time, maximum to Week 306|||||||
2586509|NCT02332590|Secondary|Sarilumab Exposure Assessed by Trough Serum Sarilumab Concentrations||Over time, maximum to Week 306|||||||
2586510|NCT02332590|Secondary|Change From Baseline in Individual ACR Component- ESR Level at Week 24|ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). The ESR is a blood test that can reveal inflammatory activity. Inflammation can cause the cells to clump together. The farther the red blood cells have descended, the greater the inflammatory response. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with ESR assessment both at baseline and Week 24.|||mm/hr||Standard Error|Least Squares Mean
2586511|NCT02332590|Secondary|Change From Baseline in Individual ACR Component - CRP Level at Week 24|"ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). An elevated CRP level was considered a non-specific marker for RA. A reduction level indicates improvement. LS mean and SE at Week 24 were obtained using MMRM approach."|Baseline, Week 24|ITT population. Number of participants analyzed = participants with CRP assessment both at baseline and Week 24.|||mg/L||Standard Error|Least Squares Mean
2586512|NCT02332590|Secondary|Change From Baseline in Individual ACR Component - Physician Global VAS, Participant Global VAS and Pain VAS at Week 24|"ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). Physician global VAS & participant global VAS was done on 100 mm horizontal anchored VAS, ranging from 0 no arthritis activity to 100 maximal arthritis activity and Pain VAS on 100 mm VAS, ranging from 0 no pain to 100 worst pain. LS mean and SE at Week 24 were obtained using MMRM approach."|Baseline, Week 24|ITT population. Number of participants analyzed = participants with individual ACR components assessment both at baseline and Week 24. Here, Number Analyzed = participants with available data for specified category for each arm, respectively.|||mm||Standard Error|Least Squares Mean
2586548|NCT02331940|Primary|Sleep Quality|"Sleep quality, meaning the architecture of sleep (amount of the different sleep stages across the sleep episode),consists of sleep efficiency (%) (total sleep time - TST divided by the total time in bed and multiplied by 100), REM (%TST) (rapid eye movement sleep divided by TST and multiplied by 100) and NREM (%TST) (non-rapid eye movement sleep divided by TST and multiplied by 100).~NORMAL RANGES Sleep efficiency: Normal is approximately 85 to 90% or higher. NREM (%TST): 75-80% REM (%TST) normally occupies about 20-25% of sleep time."|6 months after treatment initiation||||percentage of time||Standard Deviation|Mean
2586513|NCT02332590|Secondary|Change From Baseline in Individual ACR Component - TJC and SJC at Week 24|ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & acute phase reactant (hs-CRP and ESR levels). 68 joints were assessed for tenderness (TJC scoring 0-68) and 66 joints for swelling (SJC scoring 0-66). The 66 SJC evaluated the following joints: temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, interphalangeal of thumb, distal interphalangeal, proximal interphalangeal, knee, ankle mortise, ankle tarsus, metatarsophalangeal, interphalangeal of great toe, and proximal/distal interphalangeal of the toes. The TJC examined hip joints, in addition to the joints assessed for SJC. Increase in number of tender joints/swollen joints indicated severity. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with TJC and SJC assessment both at baseline and Week 24.|||joints||Standard Error|Least Squares Mean
2586514|NCT02332590|Secondary|Change From Baseline in Morning Stiffness VAS at Week 24|RA is associated with stiffness of joints, especially in the morning after prolonged stationery state. The degree of stiffness can be an indicator of disease severity. The severity of morning stiffness was assessed on a VAS scale from 0 mm (no problem) to 100 mm (major problem). LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with morning stiffness VAS assessment both at baseline and Week 24.|||mm||Standard Error|Least Squares Mean
2586515|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: RA Interference With Household Work Productivity|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). The RA interference in the last month with household work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2586516|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Outside Help Hired Due to Arthritis|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with outside help hired in the last month by the participant was reported. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed =participants with WPS-RA: Individual items assessment both at baseline and Week 24.|||days||Standard Error|Least Squares Mean
2586517|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Family/Social/Leisure Activities Missed Due to Arthritis|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days missed of family/social/leisure activities in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.|||days||Standard Error|Least Squares Mean
2586518|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Household Work Productivity Reduced by ≥ 50% Due to Arthritis|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with reduced household work productivity by ≥ 50% in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.|||days||Standard Error|Least Squares Mean
2586519|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: House Work Days Missed Due to Arthritis|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with no household work in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.|||days||Standard Error|Least Squares Mean
2586520|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: Arthritis Interference With Work Productivity|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Interference in the last month with work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT Population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2586549|NCT02331940|Primary|Sleeping Oxygen Saturation|Mean sleeping oxygen saturation (%)|6 months after treatment initiation||||percentage of Oxygen Saturation||Standard Deviation|Mean
2586550|NCT02331680|Secondary|Change in Total Volume of Fluid Removed by Dialysis Per Week|Change in total volume of fluid removed by dialysis per week from baseline to the end of the treatment was calculated using descriptive statistics.|Baseline，End of the treatment||||mL||Standard Deviation|Mean
2598647|NCT02183792|Other Pre-specified|Cumulative Furosemide Dose||Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days|||||||
2586521|NCT02332590|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Work Productivity Reduced by ≥ 50% Due to Arthritis|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days with reduced productivity by ≥ 50% in the last month by the participants was reported. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.|||days||Standard Error|Least Squares Mean
2586522|NCT02332590|Secondary|Change From Baseline in Work Productivity Survey - Rheumatoid Arthritis (WPS-RA) at Week 24: Work Days Missed Due to Arthritis|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire is interviewer-administered and based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days missed in the last month by the participant was reported. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA: Individual items assessment both at baseline and Week 24.|||days||Standard Error|Least Squares Mean
2586523|NCT02332590|Secondary|Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) at Week 24|RAID is a composite measure of the impact of RA on participants that takes into account 7 domains: pain, functional disability, fatigue, physical and emotional well-being, quality of sleep, and coping. The RAID is calculated based on 7 numerical rating scales (NRS) questions. Each NRS is assessed as a number between 0 and 10 that corresponds to the 7 domains. The values for each of these domains are weighed by participant assessment of relative importance and combined in a single and calculated with a total score range of 0 (not affected, very good) to 10 (most affected). LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with RAID assessment both at baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2586524|NCT02332590|Secondary|Change From Baseline in European Quality of Life-5 Dimension 3 Level (EQ-5D-3L) Scores at Week 24|EQ-5D-3L is a standardized, generic measure of health outcome. EQ-5D was designed for self-completion by participants. EQ-5D specifically included to address concerns regarding the health economic impact of RA. EQ-5D-3L comprises of 5 questions on mobility, self-care, pain/discomfort, usual activities, and psychological status with 3 possible answers for each item (1=no problem, 2=moderate problems, 3=severe problems). The 5-dimensional 3-level systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-3L-VAS records the participant's self-rated health on a vertical VAS that allows the participants to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable). LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with EQ-5D-3L score assessment both at baseline and Week 24. Here, Number Analyzed = participants with available data for specified category for each arm, respectively.|||units on a scale||Standard Error|Least Squares Mean
2586525|NCT02332590|Secondary|Change From Baseline in CDAI at Week 24|CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: SJC (28 joints), TJC (28 joints), participant's global disease activity (in cm), and physician's global assessment of disease VAS (in cm). Total score ranges from 0 to 76 with a lower score indicating less disease activity. A negative change in CDAI score indicates an improvement in disease activity and a positive change in score indicates a worsening of disease activity. LS means and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with CDAI assessment both at baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2586526|NCT02332590|Secondary|Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Remission (CDAI ≤2.8) at Week 24|CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: SJC (28 joints), TJC (28 joints), participant's global disease activity (in cm), and physician's global assessment (in cm). Total score ranges from 0 to 76 with a lower score indicating less disease activity. Participants were analyzed as non-responders from the time they discontinued treatment.|Week 24|ITT population.|||percentage of participants|||Number
2586527|NCT02332590|Secondary|Percentage of Participants Achieving Low Disease Activity (DAS28-ESR < 3.2) at Week 24|DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. Participants were analyzed as non-responders from the time they discontinued treatment.|Week 24|ITT Population.|||percentage of participants|||Number
2586528|NCT02332590|Secondary|Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP <2.6) at Week 24|DAS28-CRP is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by hs-CRP in mg/L. The DAS28-CRP score provides a number indicating the current disease activity of the RA. DAS28-CRP total score ranges from 2-10. A DAS28-CRP score above 5.1 means high disease activity, whereas a DAS28-CRP score below 3.2 indicates low disease activity and a DAS28-CRP score below 2.6 means disease remission. Participants were analyzed as non-responders from the time they discontinued treatment.|Week 24|ITT population.|||percentage of participants|||Number
2586551|NCT02331680|Primary|Change From Baseline in Daily Urine Volume|Change in daily urine volume from baseline to the end of the treatment was calculated using descriptive statistics.|Baseline，End of the treatment||||mL||Standard Deviation|Mean
2586552|NCT02331589|Secondary|Adiponectin|enzyme-linked immunosorbent assay|3 weeks of KRG||||pg/mL||Standard Deviation|Mean
2586553|NCT02331589|Secondary|Pro-inflammatory Cytokine|tumor necrosis factor-alpha, interleukin-6|3 weeks of KRG||||pg/mL||Standard Deviation|Mean
2586529|NCT02332590|Secondary|Change From Baseline in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP Score) at Week 24|DAS28-CRP is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28-CRP score provides a number indicating the current disease activity of the RA. DAS28-CRP total score ranges from 2-10. A DAS28-CRP score above 5.1 means high disease activity, whereas a DAS28-CRP score below 3.2 indicates low disease activity and a DAS28-CRP score below 2.6 means disease remission. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with DAS28-CRP score assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2586530|NCT02332590|Secondary|Change From Baseline in SF-36 - Mental Health Component Summary Score at Week 24|SF-36 is a generic 36-item questionnaire consisting of 8 sub-scales, measures HRQL in the last 4 weeks covering 2 summary measures: PCS and MCS. PCS with 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception; and MCS with 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same sub-scale give the sub-scale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Both PCS and MCS range from 0-100 with higher scores indicating better physical and mental health. LS mean and SE at Week 24 by MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with SF-36 - mental health component summary score assessment both at baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2586531|NCT02332590|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24|The FACIT-F is a 13-item questionnaire assessing fatigue where participants scored each item on a 5-point scale (0-4): 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. A total score range from 0 to 52, where higher score corresponds to a lower level of fatigue. A positive change from baseline score indicates an improvement. LS mean and SE at Week 24 by MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with FACIT-F score assessment both at baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2586532|NCT02332590|Secondary|Change From Baseline in Short-Form-36 (SF-36) - Physical Component Summary (PCS) Score at Week 24|SF-36 is a generic 36-item questionnaire consisting of 8 sub-scales, measures health-related quality of life (HRQL) in the last 4 weeks covering 2 summary measures: PCS and mental component summary (MCS). PCS with 4 sub-scales: physical function, role limitations due to physical problems, pain, and general health perception; and MCS with 4 sub-scales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a sub-scale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same sub-scale give the sub-scale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Both PCS and MCS range from 0-100 with higher scores indicating better physical and mental health. LS mean and SE at Week 24 by MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with SF-36 PCS score assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2586533|NCT02332590|Secondary|Change From Baseline in HAQ-DI at Week 24|Physical function was assessed by HAQ-DI. It consisted of at least 2 or 3 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3, where 0 = no disability and 3 = unable to do, high-dependency disability. LS mean and SE at Week 24 were obtained using MMRM approach.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with HAQ-DI assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2586534|NCT02332590|Secondary|Percentage of Participants Achieving ACR20 Criteria at Week 24|ACR responses are assessed with a composite rating scale of the ACR that includes 7 variables: TJC (68 joints); SJC (66 joints); levels of an acute phase reactant (CRP level); participant's assessment of pain (measured on 0 [no pain]-100 mm [worst pain] VAS); participant's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by HAQ-DI, with scoring range of 0 [better health] - 3 [worst health]). ACR20 was defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments. Participants were analyzed as non-responders from the time they discontinued treatment.|Week 24|ITT population.|||percentage of participants|||Number
2586535|NCT02332590|Secondary|Percentage of Participants Achieving ACR70 Criteria at Week 24|ACR responses are assessed with a composite rating scale of the ACR that includes 7 variables: TJC (68 joints); SJC (66 joints); levels of an acute phase reactant (CRP level); participant's assessment of pain (measured on 0 [no pain]-100 mm [worst pain] VAS); participant's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by HAQ-DI, with scoring range of 0 [better health] - 3 [worst health]). ACR70 was defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments. Participants were analyzed as non-responders from the time they discontinued treatment.|Week 24|ITT Population.|||percentage of participants|||Number
2586589|NCT02330627|Secondary|Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response in the Striatum and Insula, as Measured With Functional Magnetic Resonance Imaging (fMRI) During Loss Trials on the Monetary Incentive Delay (MID) Task|Change from pre- to post-assessment in neural activation during loss trials on the MID|Baseline, 10 weeks||2021-03-31|03/2021||||
2599447|NCT02174523|Primary|Lurasidone AUC0-∞||pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose|All subjects with evaluable PK data were included in PK data analysis.|||ng･h/mL||Standard Deviation|Geometric Mean
2586536|NCT02332590|Secondary|Percentage of Participants Achieving ACR50 Criteria at Week 24|ACR responses are assessed with a composite rating scale of the ACR that includes 7 variables: TJC (68 joints); SJC (66 joints); levels of an acute phase reactant (C-reactive protein [CRP] level); participant's assessment of pain (measured on 0 [no pain]-100 mm [worst pain] VAS); participant's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by Health Assessment Questionnaire - Disability Index [HAQ-DI], with scoring range of 0 [better health] - 3 [worst health]). ACR50 is defined as achieving at least 50% improvement in both TJC and SJC, and at least 50% improvement in at least 3 of the 5 other assessments of the ACR. Participants were analyzed as non-responders from the time they discontinued treatment.|Week 24|ITT Population.|||percentage of participants|||Number
2586537|NCT02332590|Secondary|Percentage of Participants Achieving Clinical Remission Score (DAS28-ESR <2.6) at Week 24|DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH assessment by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. Participants who discontinued treatment prior to Week 24 were analyzed as non-responders.|Week 24|ITT Population.|||percentage of participants|||Number
2586538|NCT02332590|Primary|Change From Baseline in Disease Activity Score for 28 Joints - Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Week 24|DAS28-ESR is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the American College of Rheumatology (ACR) rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS); Marker of inflammation assessed by ESR in mm/hr. The DAS28-ESR score provides a number indicating the current disease activity of the RA. DAS28-ESR total score ranges from 2-10. A DAS28-ESR score above 5.1 means high disease activity, DAS28-ESR score below 3.2 indicates low disease activity and DAS28-ESR score below 2.6 means disease remission. Least square (LS) mean and standard error (SE) at Week 24 were obtained using Mixed-effect model with repeated measures (MMRM) approach.|Baseline, Week 24|Intent-to-treat (ITT) population included all participants. Number of participants analyzed = participants with DAS28-ESR assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2586539|NCT02332239|Secondary|Acceptability/Feasibility: Participant Satisfaction|The Customer Satisfaction Questionnaire (CSQ-8) developed by Larsen et al. (1979) is an 8-item survey where each item is scored 1 (poor) to 4 (excellent). It is scored by summing the individual item scores to produce a range of 8 to 32, with high scores indicating greater satisfaction.|8 weeks post-enrollment (close of intervention)||||units on a scale||Standard Deviation|Mean
2586540|NCT02332239|Secondary|Acceptability/Feasibility: Engagement of Intervention Group|Among the intervention group, how many participants responded to at least one of the daily text message queries, and how many requested on-demand support text-messages.|Enrollment to 16 weeks post-enrollment||||Participants|||Count of Participants
2586541|NCT02332239|Secondary|Acceptability/Feasibility: Follow Up Rate|Retention Rate: % of consented participants who completed follow up|8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)||||Participants|||Count of Participants
2586542|NCT02332239|Primary|Change in Peer Violence Involvement|The Physical Assault subscale of the Conflict Tactics Scale (CTS-2), developed by Straus et al. (1996), was used to analyze changes in past-two-month peer violence in iDOVE participants, relative to an automated health-and-safety brief intervention and text message program. There are 14 items that measure violent behavior, each scored based on how frequently the participant has experienced the behavior (0=never to 6=20+ times). Score is summed, so the minimum score possible is 14*0=0 (lowest level of violence) and the maximum score possible is 14*6=84 (highest level of violence).|Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)|Stratified by higher baseline violence (CTS score >=4)|||units on a scale||Full Range|Median
2586543|NCT02332239|Primary|Change in Depressive Symptoms|Becks Depression Inventory (BDI-2): To analyze changes in past-two-week depressive symptoms in iDOVE participants, relative to an automated health-and-safety brief intervention and text message program. The Beck Depression Inventory (BDI-2) is a 1996 revision of the BDI, developed in response to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV, which changed many of the diagnostic criteria for Major Depressive Disorder. Participants were asked to rate how they have been feeling for the past two weeks. It contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.|Enrollment, 8 weeks post-enrollment (close of intervention), 16 weeks post-enrollment (8 wks after close of intervention)|"Stratified by baseline moderate depressive symptoms (BDI>=20)."|||units on a scale||Standard Deviation|Mean
2586544|NCT02331992|Secondary|Healthcare Provider Feedback|Healthcare providers will be provided questionaires so as to provide program feedback.|1 month||||Participants|||Count of Participants
2586545|NCT02331992|Primary|Participant Providing Feedback|Participants will be provided questionnaires so as to provide program feedback.|1 month||||Participants|||Count of Participants
2586546|NCT02331940|Secondary|Hospitalization Rate|Number of patients needed hospitalization|6 months after treatment initiation||||participants|||Number
2586547|NCT02331940|Secondary|Sleepiness|Sleepiness - Epworth Sleepiness Scale (ESS) score (range 0-24, higher values indicate worse outcome, >10 indicates sleepiness, >16 excessive sleepiness)|6 months after treatment initiation||||units on a scale||Standard Deviation|Mean
2586601|NCT02330549|Secondary|Change From Baseline in Liver Transaminase: Aspartate Aminotransferase (AST)|Blood was collected and was sent to a central laboratory for analysis of AST. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline to Weeks 12 and 24|Safety Population included all participants who received at least one dose of study drug. Number analyzed were the participants with analysis values at specified time point.|||U/L||Standard Deviation|Mean
2586554|NCT02331589|Secondary|Fatigue as Measured by KRUPP's Fatigue Severity Scale|"KRUPP's fatigue severity scale.~The survey has nine questions as following:~my motivation is lower, when I am fatigued~exercise brings on my fatigue~I am easily fatigued~fatigue interferes with my physical functioning~fatigue causes frequent problems for me~my fatigue prevents sustained physical functioning~fatigue interferes with carrying out certain duties and responsibilities~fatigue is among my 3 most disabling symptoms~fatigue interferes with my work, family, or social life. All subjects scored each question on a 7-point scale (1 = strongly disagree to 4 = neither disagree nor agree to 7 = strongly agree).~Scores range from 9 to 63, with higher scores indicating higher fatigue"|3 weeks of KRG||||scores on a scale||Standard Deviation|Mean
2586555|NCT02331589|Primary|Liver Enzymes|aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase|3 weeks of KRG||||U/L||Standard Deviation|Mean
2586556|NCT02331446|Primary|Change in Superoxide Dismutase Activity||Weeks 0, 6 and 12||||U/mg protein||Standard Deviation|Mean
2586557|NCT02331446|Other Pre-specified|Chronic Use of Medication|Measured by a questionnaire and quantified categorically in: No; Yes. This variable refers to a chronic use of any medication. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.|Week 0||||participants|||Number
2586558|NCT02331446|Other Pre-specified|Age|The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.|Week 0||||years||Inter-Quartile Range|Median
2586559|NCT02331446|Other Pre-specified|Household Income|Measured by a questionnaire and quantified by the income of all persons in the participant's home. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.|Week 0||||US$||Inter-Quartile Range|Median
2586560|NCT02331446|Other Pre-specified|Educational Level|Measured by a questionnaire and quantified categorically in: Incomplete primary school; Primary school; Incomplete high school; High school; Incomplete higher education; Higher education. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.|Week 0||||participants|||Number
2586561|NCT02331446|Other Pre-specified|Change in Calories Intake|Measured by a 24-hour food recall and quantified in calories|Weeks 0 and 12||||cal||Standard Deviation|Mean
2586562|NCT02331446|Other Pre-specified|Change in Minutes Per Week of Physical Activity Out of Intervention|Measured by the commuting and leisure sections of the International Physical Activity Questionnaire|Week 0 and 12||||minutes per week||Inter-Quartile Range|Median
2586563|NCT02331446|Other Pre-specified|Change in Body Mass Index||Weeks 0 and 12||||kg/m²||Inter-Quartile Range|Median
2586564|NCT02331446|Secondary|Change in Handgrip Strength|Measured using a handgrip dynamometer and quantified in kilogram-force|Weeks 0 and 12||||kgf||Standard Deviation|Mean
2586565|NCT02331446|Secondary|Change in Performance in the Six-minute Walk Test||Weeks 0 and 12||||Meters||Standard Deviation|Mean
2586566|NCT02331446|Primary|Change in Glutathione Peroxidase Activity||Weeks 0, 6 and 12||||U/mg protein||Standard Deviation|Mean
2586567|NCT02331446|Primary|Change in Total Thiol Content||Weeks 0, 6 and 12||||nmol TNB/mg protein||Standard Deviation|Mean
2586568|NCT02331446|Primary|Change in Thiobarbituric Acid Reactive Substances||Weeks 0, 6 and 12||||nmol TBARS/mg protein||Standard Deviation|Mean
2586569|NCT02331446|Primary|Change in Butyrylcholinesterase Activity||Weeks 0, 6 and 12||||µmol BuSCh/h/mg of protein||Standard Deviation|Mean
2586570|NCT02331446|Primary|Change in Adenosine Deaminase Activity||Weeks 0, 6 and 12||||U/L||Standard Deviation|Mean
2586571|NCT02331446|Primary|Change in Interleukin-6||Weeks 0, 6 and 12||||pg/mL||Inter-Quartile Range|Median
2586572|NCT02331407|Secondary|Action Research Arm Test|The ARAT tests hand and arm function and consists of 19 items in 4 domains: grasp, grip, pinch, and gross movement. Each domain contains items arranged into hierarchical order of difficulty such that success at the most difficult item of a specific subclass assumes success for all items lower in the hierarchy of the same class. Each item is scored on a four-point ordinal scale for total score between a minimum score of 0 and a maximum score of 57. A higher score indicates a better outcome.|baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy||||score on a scale||Standard Deviation|Mean
2586573|NCT02331407|Secondary|Fugl-Meyer (FM) Upper Extremity Motor Assessment|The FM is a measure of impairment that considers movement arm, wrist, hand, and coordination. Each of the 22 items is scored on a three-point ordinal scale for total score between a minimum score of 0 and a maximum score of 66. A higher score indicates a better outcome.|baseline (1 and 3 weeks prior to therapy), within 1 week after therapy, 3 weeks after therapy||||score on a scale||Standard Deviation|Mean
2586574|NCT02331407|Primary|Change in Arm Motor Control From Baseline Measured as Average Squared Mahalanobis Distance|Arm motor control was assessed through analysis of reaching movements to targets. We derive a measure of arm motor control using functional principal components analysis of reaching trajectories (average squared Mahalanobis distance). This is a unitless measure and lower change values reflect improvement in motor control, while a higher change value reflect a worsening in motor control.|From baseline to within 1 week post-therapy||||unitless|||Number
2586575|NCT02331368|Secondary|The Estimated Percentage of Patients Alive at 2 Years||2 Years|32 patients were enrolled. 3 withdrew consent prior to treatment. Of the 29 treated, 26 were evaluable for response (subjects who received 2-9 doses of MK-3475 were evaluable). Of the 26, 23 completed end-of-treatment response evaluation and were included in primary endpoint analysis.|||percentage of patients|||Number
2586576|NCT02331368|Secondary|The Estimated Percentage of Patients Alive Without Relapse or Progression at 2 Years|"Progression is defined as an increase of ≥ 25% from the lowest response value in any one or more of the following:~Serum M-component with an absolute increase ≥ 0.5 g/dL; and/or Urine M-component with an absolute increase ≥ 200 mg/24 hours; and/or Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be >100mg/l) Bone marrow plasma cell percentage (absolute % must be ≥10% Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas Development of hypercalcemia (corrected serum calcium >11.5mg/100ml) that can be attributed solely to the plasma cell proliferative disorder"|2 Years|32 patients were enrolled. 3 withdrew consent prior to treatment. Of the 29 treated, 26 were evaluable for response (subjects who received 2-9 doses of MK-3475 were evaluable). Of the 26, 23 completed end-of-treatment response evaluation and were included in primary endpoint analysis.|||percentage of patients||95% Confidence Interval|Number
2586577|NCT02331368|Primary|The Number of Patients That Achieve Complete Response|The primary efficacy endpoint is complete response rate. The complete response rate was estimated by the observed proportion of complete responders at day 180. Complete response (CR) was defined as negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and <5% plasma cells in bone marrow and negative bone marrow flow cytometry.|180 days post-transplant|32 patients were enrolled. 3 withdrew consent prior to treatment. Of the 29 treated, 26 were evaluable for response (subjects who received 2-9 doses of MK-3475 were evaluable). Of the 26, 23 completed end-of-treatment response evaluation.|||Participants|||Count of Participants
2586578|NCT02331108|Secondary|Measurement of Blood Pressure|Blood pressure decrease after intravenous anesthetic induction|intraoperative|Percentage of patients whose blood pressure decreased after propofol administration|||percentage of patients|||Number
2586579|NCT02331108|Primary|Temperature Below 36.0 Degrees C|Percentage of patients who had at least one temperature below 36.0 degrees C in the first hour of anesthesia|Intraoperative|Percentage of patients who had one core temperature reading below 36.0 degree C in the first hour of anesthesia|||Percentage|||Number
2586580|NCT02331108|Primary|Measurement of Core Temperature|Core temperature at 15 minute intervals|intraoperative||||degree C||Standard Deviation|Mean
2586581|NCT02330978|Secondary|Changes in Retinal Ganglion Cells Function by ERG||6 months|||||||
2586582|NCT02330978|Secondary|Changes in Optical Coherence Tomography Parameters Related to Glaucoma||6 months|||||||
2586583|NCT02330978|Secondary|Changes in Visual Field||6 months|||||||
2586584|NCT02330978|Secondary|Changes in Visual Acuity||6 months|||||||
2586585|NCT02330978|Primary|Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR)|Retinal detachment|6 months||||Participants|||Count of Participants
2586586|NCT02330627|Other Pre-specified|Change From Baseline in Depression (Patient Health Questionnaire-9; Beck Depression Inventory-II Composite)|"The Patient Health Questionnaire-9 (PHQ-9) measures depression symptoms. Items are rated on a 4 point scale, 0 (Not at all) to 3 (Nearly every day). The scale ranges from 0-27 and higher scores indicate higher levels of depression.~The Beck Depression Inventory-II (BDI-II) measures the severity of depression. Participants choose 1 of 4 response options; a value of 0 to 3 is assigned to each response option. The scale ranges from 0-63 and higher scores indicate higher severity of depression.~Participants' composite scores on the PHQ-9 and the BDI-II were first standardized across assessment sessions by converting to Z scores (M=0, SD=1) across both groups. The composite index of depression at each assessment point (i.e., pre assessment - at baseline, post assessment - 10 weeks after baseline) was the mean of the Z scores for that occasion. Lower z-scores indicate a decrease in depression from baseline to post-treatment."|Baseline, 10 weeks|One participant in the delayed treatment (waitlist) arm initiated an alternate treatment following the pre-assessment and was thus excluded from the analysis.|||z-score||Standard Deviation|Mean
2586587|NCT02330627|Other Pre-specified|Change From Baseline in Anxiety (Overall Anxiety Severity and Impairment Scale; State Trait Anxiety Inventory - Trait Composite)|"The Overall Anxiety Severity and Impairment Scale (OASIS) measures frequency, severity, and functional impairment of anxiety symptoms. Items are rated on a 4 point scale, 0 (None) to 4 (Extreme). The scale ranges from 0-20 and higher scores indicate higher levels of anxiety.~The State Trait Anxiety Inventory - Trait (STAI-T) measures general anxiety. Items are rated on a 4 point scale, 1 (Almost Never) to 4 (Almost Always). The scale ranges from 20-80 and higher scores indicate higher levels of anxiety.~Participants' composite scores on the OASIS and the STAI were first standardized across assessment sessions by converting to Z scores (M=0, SD=1) across both groups. The composite index of anxiety at each assessment point (i.e., pre assessment - at baseline, post assessment - 10 weeks after baseline) was the mean of the Z scores for that occasion. Lower z-scores indicate a decrease in anxiety from baseline to post-treatment."|Baseline, 10 weeks|One participant in the delayed treatment (waitlist) arm initiated an alternate treatment following the pre-assessment and was thus excluded from the analysis.|||z-score||Standard Deviation|Mean
2586588|NCT02330627|Other Pre-specified|Change From Baseline in Quality of Life and Well-being (Composite of Quality of Life, Enjoyment, and Satisfaction Questionnaire; Satisfaction With Life Scale)|"The Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q) measures the degree of satisfaction experienced by participants in various areas of daily functioning. Items are rated on a 5 point scale, 1 (Very Poor) to 5 (Very Good). The scale ranges from 14-70; higher scores indicate higher levels of life satisfaction.~The Satisfaction With Life Scale (SWLS) measures global cognitive judgments of one's life satisfaction. Items are rated on a 7 point scale, 1 (Strongly Disagree) to 7 (Strongly Agree). The scale ranges from 5-35; higher scores indicate higher levels of life satisfaction.~Participants' scores on the Q-LES-Q and the SWLS were first standardized across assessment sessions by converting to Z scores (M=0, SD=1) across both groups. The composite index of quality of life and well-being at each assessment point was the mean of the Z scores for that occasion. Higher z-scores indicate an increase in quality of life and well-being from baseline to post-treatment."|Baseline, 10 weeks|One participant in the delayed treatment (waitlist) arm initiated an alternate treatment following the pre-assessment and was thus excluded from the analysis.|||z-score||Standard Deviation|Mean
2586659|NCT02330172|Secondary|Recovery Time From Neuromuscular Blockade|We measured recovery time ffrom the injection of neostigmine or sugammadex to TOF ratio 0.9|from the injection of neostigmine or sugammadex up to 30 minutes||||minute||Standard Deviation|Mean
2586590|NCT02330627|Secondary|Change From Baseline in Negative Affect (Positive and Negative Affect Schedule; Modified Differential Emotions Scale; Composite)|"The Positive and Negative Affect Schedule (PANAS) measures negative affect. Items are answered on a 5 point scale, 1 (Very slightly or not at all) to 5 (Extremely). The negative affect scale ranges from 10-50 and lower scores indicate lower levels of negative affect.~The Modified Differential Emotions Scale (mDES) measures negative emotions. Items are answered on a 5 point scale, 0 (Never/Not at all) to 4 (Most of the time/Extremely). Lower scores on the negative emotions sub-scale indicate lower levels of negative emotion.~Participants' composite scores on the PANAS and mDES were first standardized across assessment sessions by converting to Z scores (M=0, SD=1) across both groups. The composite index of negative affect at each assessment point (i.e., pre assessment - at baseline, post assessment - 10 weeks after baseline) was the mean of the Z scores for that occasion. Lower z-scores indicate a decrease in negative affect from baseline to post-treatment."|Baseline, 10 weeks|One participant in the delayed treatment (waitlist) arm initiated an alternate treatment following the pre-assessment and was thus excluded from the analysis.|||z-score||Standard Deviation|Mean
2586591|NCT02330627|Primary|Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response in the Striatum and Medial Prefrontal Cortex, as Measured With Functional Magnetic Resonance Imaging (fMRI) During Reward Trials on the Monetary Incentive Delay (MID) Task|Change from pre- to post-assessment in neural activation during reward trials on the MID task.|Baseline, 10 weeks||2021-03-31|03/2021||||
2586592|NCT02330627|Primary|Change From Baseline in Positive Affect (Positive and Negative Affect Schedule; Modified Differential Emotions Scale; Composite)|"The Positive and Negative Affect Schedule (PANAS) measures positive affect. Items are answered on a 5 point scale, 1 (Very slightly or not at all) to 5 (Extremely). The positive affect scale ranges from 10-50 and higher scores indicate greater levels of positive affect.~The Modified Differential Emotions Scale (mDES) measures positive emotions. Items are answered on a 5 point scale, 0 (Never/Not at all) to 4 (Most of the time/Extremely). Higher scores on the positive emotions sub-scale indicate higher levels of positive emotion.~Participants' scores on the PANAS and mDES were first standardized across assessment sessions by converting to Z scores (M=0, SD=1) across both groups. The composite index of positive affect at each assessment point was the mean of the Z scores for that occasion. Higher z-scores indicate an increase in positive affect from baseline to post-treatment."|Baseline, 10 weeks|One participant in the delayed treatment (waitlist) arm initiated an alternate treatment following the pre-assessment and was thus excluded from the analysis.|||z-score||Standard Deviation|Mean
2586593|NCT02330588|Secondary|Parents' Concern About Children's Weight Status and Motivation to Change Lifestyle Behaviors Immediately Following the SBIRT.|"A brief, eight-item Likert scale questionnaire with established face validity has been adopted from Campbell et al. (2011) and will assess parents' concern for and motivation to support their child's lifestyle behaviors. Concern and motivation to change were measured on a 5-point Likert scale ('strongly disagree' [0] to 'strongly agree' [4]); for example, I am ready to change my child's lifestyle behaviors, a 0 would indicate that participants strongly disagree with this statement."|Measured at baseline||||units on a scale (0 to 4 Likert Scale)||95% Confidence Interval|Mean
2586594|NCT02330588|Primary|Feasibility (Parents' Uptake of the SBIRT)|Parents' uptake was determined by parents' use (actual and self-reported) of obesity prevention resources (i.e., the proportion [reported in percentage] that actually or self-reported using resources out of the total number of participants that participated in follow-up), and the proportion (reported in percentage) of parents that reported discussing children's weight with their pediatrician immediately following the SBIRT.|One-month follow-up|Participants who completed one-month follow-up.|||percentage of participants|||Number
2586595|NCT02330588|Primary|Feasibility (Parents' Interest in the SBIRT.)|Parents' interest was determined by the proportion (indicated as a percentage) of parents that (i) enrolled among those approached to participate, (ii) 'opted in' to receive the tailored email report, and (iii) self-selected resources from the SBIRT; the latter two were recorded by back-end programming of the SBIRT.|Baseline|Parents who participated at baseline.|||percentage of parents|||Number
2586596|NCT02330549|Secondary|Number of Participants With Abnormal Physical Examination Findings|Physical examination included assessment of the following body systems: Abdomen, Cardiovascular, Extremities, Head, Eyes, Ears, Nose, Throat, Lungs, Lymph Nodes, Neurological, Skin and Thyroid. The number of participants with any abnormal findings at Baseline and participants with any abnormal findings Post-Baseline are reported.|24 weeks|Safety Population included all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2586597|NCT02330549|Secondary|Plasma Cenicriviroc Concentrations||Baseline (Day 1) one sample predose; Weeks 2, 12 and 24 one sample predose and one sample postdose|Pharmacokinetic (PK) Population included all participants in the safety population who received at least 1 dose of study drug and had at least 1 PK assessment.|||ng/mL||Standard Deviation|Mean
2586598|NCT02330549|Secondary|Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results|A standard 12 lead ECG was performed. The investigator determined if the abnormal results were clinically significant.|Baseline 24 weeks|Safety Population included all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2586599|NCT02330549|Secondary|Number of Participants With Clinically Relevant Changes From Baseline in Vital Signs|Vital signs included Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate, Respiratory Rate and Temperature. The investigator determined if the vital sign measurements were clinically relevant.|24 weeks|Safety Population included all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2586600|NCT02330549|Secondary|Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)|An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurs or worsens after receiving study drug.|24 weeks|Safety Population included all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2586841|NCT02327169|Primary|Maximum Tolerated Dose (MTD) for MLN2480||Day 1, Cycle 1 up to 28 days|The DLT-evaluable population was defined as all participants in the dose escalation phase of the study who either experienced DLT during cycle 1, or completed at least 75% of the scheduled doses in cycle 1 without DLT.|||mg|||Number
2586604|NCT02330549|Secondary|Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Iron Content|LiverMultiscan™ tests via MRI were obtained at Baseline and at Weeks 12 and 24. A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.|Baseline to Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. LiverMultiScan™ tests were performed in a subset of participants at one site. Number analyzed were the participants with analysis values at specified time point.|||mg/g of liver||Standard Deviation|Mean
2586605|NCT02330549|Secondary|Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Liver Inflammation and Fibrosis (LIF) Score|LiverMultiscan™ tests via MRI were obtained at Baseline and at Weeks 12 and 24. The mean of 4 regions of interest as selected by the technician is reported. The LIF Score ranges from 0=no liver disease to 4=severe liver disease. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline to Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. LiverMultiScan™ tests were performed in a subset of participants at one site. Number analyzed were the participants with analysis values at specified time point.|||unit on a scale||Standard Deviation|Mean
2586606|NCT02330549|Secondary|Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: cT1 Mode Values Within the Liver|LiverMultiscan™ via MRI were obtained at Baseline and at Weeks 12 and 24. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline to Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. LiverMultiScan™ tests were performed in a subset of participants at one site. Number analyzed were the participants with analysis values at specified time point.|||ms||Standard Deviation|Mean
2586607|NCT02330549|Secondary|Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Corrected T1 (cT1)|LiverMultiscan™ via MRI were obtained at Baseline and at Weeks 12 and 24. The mean of 4 regions of interest as selected by the technician is reported. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline to Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. LiverMultiScan™ tests were performed in a subset of participants at one site. Number analyzed were the participants with analysis values at specified time point.|||milliseconds (ms)||Standard Deviation|Mean
2586608|NCT02330549|Secondary|Change From Baseline in Non-invasive Imaging by Multiparametric Magnetic Resonance Imaging (MRI) for Liver Disease (LiverMultiScan™) Test: Fat Fraction|LiverMultiscan™ tests via MRI were obtained at Baseline and at Weeks 12 and 24. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline to Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. LiverMultiScan™ tests were performed in a subset of participants at one site. Number analyzed were the participants with analysis values at specified time point.|||percentage of fat||Standard Deviation|Mean
2586609|NCT02330549|Secondary|Change From Baseline in Noninvasive Metabolic Marker: Alpha-fetoprotein (AFP)|Blood was collected and was sent to a central laboratory for analysis of AFP. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Week 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||ng/mL||Standard Deviation|Mean
2586610|NCT02330549|Secondary|Change From Baseline in Noninvasive Metabolic Serum Biomarker: Cluster of Differentiation (CD95)|Blood was collected and was sent to a central laboratory for analysis of CD95. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Week 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||ng/mL||Standard Deviation|Mean
2586611|NCT02330549|Secondary|Change From Baseline in Noninvasive Metabolic Biomarker: Mac-2 Binding Protein (Mac-2BP)|Blood was collected and was sent to a central laboratory for analysis of Mac-2BP. A negative change from Baseline indicates improvement and a positive change from Baseline indicates improvement.|Baseline (Day 1) to Week 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||ng/mL||Standard Deviation|Mean
2586612|NCT02330549|Secondary|Change From Baseline in Noninvasive Metabolic Biomarker: Fibroblast Growth Factor-21 (FGF-21)|Blood was collected and was sent to a central laboratory for analysis of FGF-21. A negative change from Baseline indicates improvement and a positive change from Baseline indicates improvement.|Baseline (Day 1) to Week 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||pg/mL||Standard Deviation|Mean
2586613|NCT02330549|Secondary|Change From Baseline in Noninvasive Metabolic Biomarker: Cytokeratin-18 (CK-18) [M30 and M65]|Blood was collected and was sent to a central laboratory for analysis of CK-18. A positive change from Baseline indicates improvement and a negative change from Baseline indicates improvement.|Baseline (Day 1) to Week 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||U/L||Standard Deviation|Mean
2586893|NCT02326844|Other Pre-specified|Secondary Mutation of Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2)|Patients will undergo a mandatory biopsy at baseline and Next Generation Sequencing to elucidate the secondary mutations of BRCA1 and BRCA2 will be performed.|Baseline||2020-03-31|03/2020||||
2586614|NCT02330549|Secondary|Change From Baseline in Noninvasive Metabolic Biomarker: Hyaluronic Acid|Blood was collected and was sent to a central laboratory for analysis of Hyaluronic Acid. A positive change from Baseline indicates improvement and a negative change from Baseline indicates improvement.|Baseline (Day 1) to Week 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||ng/mL||Standard Deviation|Mean
2586615|NCT02330549|Secondary|Change From Baseline in Biomarker of Inflammation: Tumor Necrosis Factor Alpha (TNF-α)|Blood was collected and was sent to a central laboratory for analysis of TNF-α. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Weeks 2, 12, 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||pg/mL||Standard Deviation|Mean
2586616|NCT02330549|Secondary|Change From Baseline in Biomarker of Inflammation: High Sensitivity C Reactive Protein (Hs-CRP)|Blood was collected and was sent to a central laboratory for analysis of hs-CRP. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Weeks 2, 12, 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||mg/L||Standard Deviation|Mean
2586617|NCT02330549|Secondary|Change From Baseline in Biomarker of Inflammation: Interleukin 10 (IL-10)|Blood was collected and was sent to a central laboratory for analysis of IL-1β. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Weeks 2, 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||pg/mL||Standard Deviation|Mean
2586618|NCT02330549|Secondary|Change From Baseline in Biomarker of Inflammation: Interleukin 8 (IL-8)|Blood was collected and was sent to a central laboratory for analysis of IL-8. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Weeks 2, 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||pg/mL||Standard Deviation|Mean
2586619|NCT02330549|Secondary|Change From Baseline in Biomarker of Inflammation: Interleukin 6 (IL-6)|Blood was collected and was sent to a central laboratory for analysis of IL-6. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Weeks 2, 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||pg/mL||Standard Deviation|Mean
2586620|NCT02330549|Secondary|Change From Baseline in Biomarker of Inflammation: Interleukin 1 Beta (IL-1β)|Blood was collected and was sent to a central laboratory for analysis of IL-1β. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Weeks 2, 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||pg/mL||Standard Deviation|Mean
2586621|NCT02330549|Secondary|Change From Baseline in Serum CCR5 Ligand: Macrophage Inflammatory Protein 1 Beta (MIP-1β)|Blood was collected and was sent to a central laboratory for analysis of MIP-1β. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Weeks 2, 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||pg/mL||Standard Deviation|Mean
2586622|NCT02330549|Secondary|Change From Baseline in Serum CCR5 Ligand: Macrophage Inflammatory Protein 1 Alpha (MIP-1α)|Blood was collected and was sent to a central laboratory for analysis of MIP-1α. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Weeks 2, 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||pg/mL||Standard Deviation|Mean
2586623|NCT02330549|Secondary|Change From Baseline in Serum C-C Chemokine Receptor Type 5 (CCR5) Ligand: RANTES|Blood was collected and was sent to a central laboratory for analysis of RANTES (regulated on activation normal T-cell expressed and secreted). A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Weeks 2, 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||ng/mL||Standard Deviation|Mean
2586624|NCT02330549|Secondary|Change From Baseline in Serum C-C Chemokine Receptor Type 2 (CCR2) Ligand: Monocyte Chemotactic Protein 1 (MCP-1)|Blood was collected and was sent to a central laboratory for analysis of MCP-1. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Weeks 2, 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||pg/mL||Standard Deviation|Mean
2586674|NCT02330081|Secondary|in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hematocrit||Day 0 post-collection, day 0 post-illumination, day 1 post-storage|Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).|||Percentage of total blood volume||Standard Deviation|Mean
2586625|NCT02330549|Secondary|Number of Participants by NASH Clinical Research Network (CRN) Staging Categories|Liver biopsy were performed during Screening and at Week 24 for participants diagnosed with NASH. The NASH CRN Brunt/Kleiner Fibrosis Staging System Fibrosis Stages are: 0 (None), 1 (Perisinusoidal or periportal), 1A (Mild, zone 3, perisinusoidal), 1B (Moderate, zone 3, perisinusoidal), 1C (Portal/periportal), 2 (Perisinusoidal and portal/periportal), 3 (Bridging fibrosis) and 4 (Cirrhosis).|Baseline (Screening) and Week 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Only participants confirmed at Screening with NASH by biopsy and had a biopsy conducted at Week 24 were included.|||Participants|||Count of Participants
2586626|NCT02330549|Secondary|Change From Baseline in the Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)|Liver biopsy were performed during Screening and at Week 24 only for participants diagnosed with NASH. NAFLD activity score was determined based on 3 components: steatosis (0=<5% to 3=>66%), lobular inflammation (0=no foci to 3=>4 foci/200x) and hepatocellular ballooning (0=none to 2= many cells/prominent ballooning) for a total possible score of 0 to 8. A negative change from Baseline indicates improvement.|Baseline (Screening) to Week 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Only participants confirmed at Screening with NASH by biopsy and had a biopsy conducted at Week 24 were included in the analysis.|||score on a scale||Standard Deviation|Mean
2586627|NCT02330549|Secondary|Change From Baseline in AUC (30-120 Min) for Serum FFA|AUC(30-120 min) was derived from the serum FFA values obtained during the oral glucose tolerance test. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||min*mmol/L||Standard Deviation|Mean
2586628|NCT02330549|Secondary|Change From Baseline in AUC (0-120 Min) for Serum FFA|AUC(0-120 min) was derived from the serum FFA values obtained during the oral glucose tolerance test. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||min*mmol/L||Standard Deviation|Mean
2586629|NCT02330549|Secondary|Serum FFA at 30, 60, 90 and 120 Minutes Following Glucose Load|Blood was collected during the oral glucose tolerance test and was sent to a central laboratory for analysis of FFA.|Pre-glucose load, 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||mg/dL||Standard Deviation|Mean
2586630|NCT02330549|Secondary|Change From Baseline in Serum Resistin Concentration|A fasting blood sample was collected and was sent to a central laboratory for analysis of resistin. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||ng/mL||Standard Deviation|Mean
2586631|NCT02330549|Secondary|Change From Baseline in Serum Adiponectin Concentration|A fasting blood sample was collected and was sent to a central laboratory for analysis of adiponectin. A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.|Baseline (Day1) to Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||μg/mL||Standard Deviation|Mean
2586632|NCT02330549|Secondary|Change From Baseline in Fasting Free Fatty Acids|A fasting blood sample was collected and was sent to a central laboratory for analysis of free fatty acids. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||mg/dL||Standard Deviation|Mean
2586633|NCT02330549|Secondary|Change From Baseline in AUC (30-120 Min) for Plasma Insulin|AUC(30-120 min) was derived from the plasma insulin values obtained during the oral glucose tolerance test. A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.|Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||min*μIU/mL||Standard Deviation|Mean
2586634|NCT02330549|Secondary|Change From Baseline in AUC (0-120 Min) for Plasma Insulin|AUC(0-120 min) was derived from the plasma insulin values obtained during the oral glucose tolerance test. A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.|Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||min*μIU/mL||Standard Deviation|Mean
2586675|NCT02330081|Secondary|in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemoglobin||Day 0 post-collection, day 0 post-illumination, day 1 post-storage|Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).|||g/dL||Standard Deviation|Mean
2586635|NCT02330549|Secondary|Change From Baseline in Area Under the Concentration-time Curve From Time 30 to 120 Minutes [AUC (30-120 Min)] for Serum Glucose|AUC(30-120 min) was derived from the serum glucose values obtained during the oral glucose tolerance test. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||minutes (min)*mg/dL||Standard Deviation|Mean
2586636|NCT02330549|Secondary|Change From Baseline in Area Under the Concentration-time Curve From Time 0 to 120 Minutes [AUC (0-120 Min)] for Serum Glucose|AUC(0-120 min) was derived from the serum glucose values obtained during the oral glucose tolerance test. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Pre-glucose load) to 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||minutes (min)*mg/dL||Standard Deviation|Mean
2586637|NCT02330549|Secondary|Plasma Insulin at 30, 60, 90 and 120 Minutes Following Glucose Load|Blood was collected during the oral glucose tolerance test and was sent to a central laboratory for analysis of insulin.|Pre-glucose load, 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||μIU/mL||Standard Deviation|Mean
2586638|NCT02330549|Secondary|Plasma Glucose at 30, 60, 90 and 120 Minutes Following Glucose Load|Blood was collected during the oral glucose tolerance test and was sent to a central laboratory for analysis of glucose.|Prior to Glucose Load, 30, 60, 90 and 120 minutes after glucose load on Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||mg/dL||Standard Deviation|Mean
2586639|NCT02330549|Secondary|Change From Baseline in Plasma Glucagon Concentration|A fasting blood sample was collected and was sent to a central laboratory for analysis of glucagon. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||ng/mL||Standard Deviation|Mean
2586640|NCT02330549|Secondary|Change From Baseline in Fasting Glycosylated Hemoglobin A1c (HbA1c)|A fasting blood sample was collected and was sent to a central laboratory for analysis of glucose. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||percentage of HbA1c||Standard Deviation|Mean
2586641|NCT02330549|Secondary|Change From Baseline in Homeostasis Model Assessment of β-cell Function (HOMA-%B)|HOMA-%B= (20 × FPI)/(FPG − 3.5). A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||unit on a scale||Standard Deviation|Mean
2586642|NCT02330549|Secondary|Change From Baseline in Homeostasis Model of Insulin Resistance (HOMA-IR)|HOMA-IR = (FPG mg/dL x FPI μIU/mL)/405. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||unit on a scale||Standard Deviation|Mean
2586643|NCT02330549|Secondary|Change From Baseline in Quantitative Insulin Sensitivity Check Index (QUICKI)|QUICKI is used to measure insulin sensitivity. QUICKI = 1/(log FPI μIU/mL + log FPG mg/dL). A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.|Baseline (Day1) to Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||unit on a scale||Standard Deviation|Mean
2586644|NCT02330549|Secondary|Change From Baseline in Fasting Plasma Insulin (FPI)|A fasting blood sample was collected and was sent to a central laboratory for analysis of insulin. A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.|Baseline (Day 1) to Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||μIU/mL||Standard Deviation|Mean
2586645|NCT02330549|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|A fasting blood sample was collected and was sent to a central laboratory for analysis of glucose. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day1) to Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||mg/dL||Standard Deviation|Mean
2586694|NCT02329743|Secondary|Proportion of Subjects Reporting no Ocular Pain||Day 3||||Participants|||Count of Participants
2586695|NCT02329743|Primary|Proportion of Subjects With Clearing of Anterior Inflammation|score of zero for the Standardization of Uveitis Nomenclature scale|Day 8|ITT|||Participants|||Count of Participants
2586646|NCT02330549|Secondary|Change From Baseline in Peripheral Monocyte Subsets (CD14/CD16)|Peripheral monocyte subsets (cluster of differentiation 14 (CD14/cluster of differentiation 16 (CD16)] were measured in fresh peripheral blood mononuclear cells (PBMCs) samples by flow cytometry. Monocyte results are reported for Total, Classical (CD14+CD16-), Intermediate (CD14+CD16+) and Non-classical (CD14lowCD16+). A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Week 24|Safety Population included all participants who received at least one dose of study drug. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||cells/μL||Inter-Quartile Range|Median
2586647|NCT02330549|Secondary|Change From Baseline in C-C Chemokine Receptor Type 2 (CCR2) and C-C Chemokine Receptor Type 5 (CCR5) in Subcutaneous Adipose Tissue|CCR2 and CCR5 corresponding ligands' messenger ribonucleic acid (mRNA) gene expression were assessed in frozen adipose tissue by quantitative polymerase chain reaction (PCR). A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Week 24|Safety Population included all participants who received at least one dose of study drug. Number analyzed is the number of participants with data available at the given timepoint|||copies per sample||Inter-Quartile Range|Median
2586648|NCT02330549|Secondary|Change From Baseline in Macrophage Infiltration in Subcutaneous Adipose Tissue|Macrophage infiltration in adipose tissue was assessed in paraffin-embedded adipose punch biopsies by immunohistochemistry stained for cluster of differentiation 68 (CD68), cluster of differentiation 163 (CD163), C-C chemokine receptor type 2 (CCR2), C-C chemokine receptor type 5 (CCR5) and cluster of differentiation 206 (CD206). A reduction in infiltration indicates less inflammation. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Week 24|Safety Population included all participants who received at least one dose of study drug. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||cells/μL||Inter-Quartile Range|Median
2586649|NCT02330549|Primary|Change From Baseline in Adipose Tissue Insulin Resistance (Adipo-IR ) Index|Change in adipose insulin sensitivity was measured by Adipo-IR. Adipo-IR= (Fasting Serum free fatty acid (FFA) mmol/L x FPI μIU/mL). A higher Adipo-IR index indicates the worst disease state. A lower Adipo-IR Index is best. A negative change from Baseline indicates improvement and a positive change from Baseline indicates a worsening.|Baseline (Day 1) to Weeks 12 and 24|ITT population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||unit on a scale||Standard Deviation|Mean
2586650|NCT02330549|Primary|Change From Baseline in Matsuda Index|Change in peripheral insulin sensitivity was measured by the Matsuda Index. Fasting plasma glucose (FPG) and fasting plasma insulin (FPI) concentrations measured during the oral glucose tolerance test (OGTT) were used to calculate the Matsuda Index. Matsuda Index=10,000/square root [FPG mg/dL x FPI μIU/mL) x (mean glucose mg/dL x mean insulin μIU/mL during OGTT)]. A Matsuda index of <2.5 indicates whole body insulin resistance. A lower Matsuda Index indicates the worst disease state. An increase in the Matsuda Index indicates an improvement in insulin sensitivity (best). A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening.|Baseline (Day 1) to Weeks 12 and 24|Intent to treat (ITT) population included all participants randomized to the treatment group assigned, regardless of starting treatment or changing treatment during the study. Number analyzed is the number of participants with data available for analysis at the given timepoint.|||unit on a scale||Standard Deviation|Mean
2586651|NCT02330523|Secondary|Wound Closure at 4-weeks|Suture line gap will be measured (buccal-lingual) with a UNC-15 Probe, rounding down to the nearest 0.5 mm.|4-weeks||||mm||Standard Deviation|Median
2586652|NCT02330523|Secondary|New Bone Plus Graft Content at 6-months|"New bone and graft content are measured as histomorphometric % vital bone and % mineral (graft remnants) from mid-section bone core biopsies. Histomorphometric analyses are performed with imaging software on composite overview scans. The area of new healing (versus old/ original bony tissues) is demarcated in each section. Within this area, the percentage contributions of each tissue type within the overall area of newly healed tissue is computed, i.e., new bone plus graft content added with connective tissue/ marrow elements totals 100% of the new healing area."|Six Months||||percentage of total area||Standard Deviation|Mean
2586653|NCT02330523|Primary|Bone Ridge Buccal-Lingual and Apico-Coronal Measures at 6 Months|The primary efficacy parameter will be ridge volume preservation as measured apico-coronal and buccal-lingual using a preformed and marked stent.|Six Months||||mm||Standard Deviation|Mean
2586654|NCT02330276|Secondary|Change From Baseline in Circulating C-Peptide Concentrations (ng/mL*24hr)||Baseline and 24 hours|Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.|||ng/mL*24hr||Standard Deviation|Mean
2586655|NCT02330276|Secondary|Change From Baseline in Circulating Insulin Concentrations (uU/mL*24hr)||Baseline and 24 hours|Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.|||uU/mL*24 hr||Standard Deviation|Mean
2586656|NCT02330276|Secondary|Change From Baseline in Circulating Glucose Concentrations (mg/dL*24hr)||Baseline and 24 hours|Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.|||mg/dL*24hr||Standard Deviation|Mean
2586657|NCT02330276|Secondary|Change From Baseline in Major Safety Endpoints|Clinically significant differences in the major safety endpoints are defined as: BP (10 mm Hg change), HR (10 bpm), creatinine (>1.5 ULN), and highly conservative changes in alkaline phosphatase and liver transaminases (>1.5 ULN).|Baseline and 24 hours|Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.|||participants|||Number
2586658|NCT02330276|Primary|Change From Baseline in Circulating Urinary Concentrations of Intact Epicatechin and Epi Metabolites|This will be initial PK study on synthetic (+)-epicatechin in humans. Circulating and urinary concentrations of intact epicatechin and epicatechin metabolites, including specific enantiomers|Baseline and 24 hours|Intent to treat population (all participants who receive the medication). Last observation carried forward (LOCF) imputation method.|||nM*hr||Standard Deviation|Mean
2599893|NCT02169505|Secondary|Number of Participants With Hematologic Toxicity|The most common grade > 3 side effects on Brentuximab.|an average of 12 months||||Participants|||Count of Participants
2586660|NCT02330172|Primary|Laryngoscopic Score|"Definitions for evaluation of Laryngoscopycondition.~: Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy.~Variables Excellent Good Poor"|At the beginning of surgery, the surgeon rated the laryngoscopy condition|"Definitions for evaluation of Laryngoscopycondition.~: Easy = jaw relaxed, no resistance to blade insertion, fair = jaw not fully relaxed, slight resistance to blade insertion, difficult = poor jaw relaxation, active resistance of the patient to laryngoscopy.~Variables Excellent Good Poor"|||Participants|||Count of Participants
2586661|NCT02330094|Secondary|Pain Control Satisfaction Questionnaire|The Brigham and Women's Hospital Management of Post-operative Pain Patients discharge questionnaire (BWQ) was used to measure pain control satisfaction. The questionnaire was modified and transformed into a uniform scale so all numbers were on the same direction. Subjects were asked to answer six questions on a score of 0-5, for a total possible range of 0-30. A lower score indicated a better outcome (less pain) and higher pain control satisfaction and a higher score indicated a worse outcome (more pain) and lower pain control satisfaction.|Day 8||||score on a scale||Standard Deviation|Mean
2586662|NCT02330094|Primary|Average Narcotic Consumption|The amount of narcotics administered, averaged over a 7 day period, calculated in total morphine equivalents (ME).|baseline through day 7||||milligrams||Standard Deviation|Mean
2586663|NCT02330094|Primary|Average Numeric Pain Score|Pain was measured on a Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable. The numeric pain score was measured every 4 hours and the total score over 24 hours was averaged as the daily numeric pain score. The daily scores were then averaged over a 7 day period for a single average pain score.|baseline through day 7||||score on a scale||Standard Deviation|Mean
2586664|NCT02330081|Secondary|in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Plasma Free Hemoglobin||Day 0 post-collection, day 0 post-illumination, day 1 post-storage|Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).|||g/L||Standard Deviation|Mean
2586665|NCT02330081|Secondary|in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemolysis|"Hemolysis is the rupture or destruction of red blood cells (RBCs), which releases hemoglobin from inside the RBCs into the plasma (where it is called free hemoglobin). Hemolysis is measured as the percentage of free hemoglobin compared to the total hemoglobin in a blood sample."|Day 0 post-collection, day 0 post-illumination, day 1 post-storage|Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).|||percentage of free hemoglobin||Standard Deviation|Mean
2586666|NCT02330081|Secondary|in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Lactate||Day 0 post-collection, day 0 post-illumination, day 1 post-storage|Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).|||mmol/L||Standard Deviation|Mean
2586667|NCT02330081|Secondary|in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Glucose||Day 0 post-collection, day 0 post-illumination, day 1 post-storage|Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).|||mmol/L||Standard Deviation|Mean
2586668|NCT02330081|Secondary|in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Potassium||Day 0 post-collection, day 0 post-illumination, day 1 post-storage|Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).|||mmol/L||Standard Deviation|Mean
2586669|NCT02330081|Secondary|in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pO2||Day 0 post-collection, day 0 post-illumination, day 1 post-storage|Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).|||kPa||Standard Deviation|Mean
2586670|NCT02330081|Secondary|in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - CO2||Day 0 post-collection, day 0 post-illumination, day 1 post-storage|Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).|||kPa||Standard Deviation|Mean
2586671|NCT02330081|Secondary|in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pH|pH is a measure of the acidity or alkalinity of a solution, numerically equal to 7 for neutral solutions, increasing with increasing alkalinity and decreasing with increasing acidity. The pH scale commonly in use ranges from 0 to 14|Day 0 post-collection, day 0 post-illumination, day 1 post-storage|Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).|||units on a scale||Standard Deviation|Mean
2586672|NCT02330081|Secondary|in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Platelets||Day 0 post-collection, day 0 post-illumination, day 1 post-storage|Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).|||cells * 10e9/L||Standard Deviation|Mean
2586673|NCT02330081|Secondary|in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - White Blood Cells||Day 0 post-collection, day 0 post-illumination, day 1 post-storage|Modified Intent to Treat population (mITT) = all enrolled subjects who signed informed consent and have valid data (excluding Subjects V01 through V08 who had irreparably confounded data due to a calibration error of the radioactivity detection device).|||cells * 10e9/L||Standard Deviation|Mean
2586676|NCT02330081|Primary|Relative Platelet Survival|Mean survival time of platelets derived from Mirasol-treated whole blood (WB) units that had been stored for 24 ± 1 hours at 22 ± 2ºC as compared to the mean survival time of fresh platelets from the same donor, measured in hours. Platelets were isolated from both Mirasol-treated WB and from fresh WB from the same participant, radiolabeled with either 111Indium or 51Chromium, and these 2 radiolabeled platelet samples (ie, 1 untreated, fresh and 1 Mirasol-treated, stored) were combined and reinfused back to the same participant.|Days 1 through 10 post-infusion|Per Protocol Population = all subjects in the mITT Population who met all of the inclusion and none of the exclusion criteria at enrollment, had no concurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had completed all postinfusion blood sampling for recovery and survival calculations and had no protocol violations.|||hours||95% Confidence Interval|Mean
2586677|NCT02330081|Primary|Platelet 24-hour Relative Recovery|Relative recovery of platelets derived from Mirasol-treated whole blood (WB) units that had been stored for 24 ± 1 hours at 22 ± 2ºC, measured as a percentage of platelets derived from freshly collected WB from the same participant. Platelets were isolated from both Mirasol-treated WB and from fresh WB from the same participant, radiolabeled with either 111Indium or 51Chromium, and these 2 radiolabeled platelet samples (ie, 1 untreated, fresh and 1 Mirasol-treated, stored) were combined and reinfused back to the same participant.|24 hours|Per Protocol Population = all subjects in the mITT Population who met all of the inclusion and none of the exclusion criteria at enrollment, had no concurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had completed all postinfusion blood sampling for recovery and survival calculations and had no protocol violations.|||Percentage of platelet count||95% Confidence Interval|Mean
2586678|NCT02330055|Secondary|Average Pulse Rate|As measured in beats per minute|48 Hours after delivery||||beats per minute||Inter-Quartile Range|Median
2586679|NCT02330055|Secondary|Pain-score on a Verbal Numerical Rating Scale|Assessment of intensity of acute pain. Measured from 0-10, 0 being no pain and 10 being highest level of pain.|48 hours after delivery||||units on a scale||Inter-Quartile Range|Median
2586680|NCT02330055|Secondary|STOP-BANG Score|The STOP BANG (This abbreviation consists of the first letter of each question in the questionnaire. S-Snore, T-Tired, O-Observed stop in breathing, P-High blood pressure, B-BMI, A - Age, N-Neck circumference, G-Gender. This questionnaire is a proven tool that can be used to screen for obstructive sleep apnea (OSA). This tool will assess if you are low, moderate or high risk group for sleep apnea. Scores range from 0-8. 0 indicates low risk for sleep apnea, 8 indicates high risk for sleep apnea.|48 hours after delivery||||units on a scale||Inter-Quartile Range|Median
2586681|NCT02330055|Secondary|P-SAP Score|A Perioperative sleep apnea prediction (P-SAP) Score. This score ranges from 0 to 69, 0 representing low risk of obstructive sleep apnea and 69 representing high risk of obstructive sleep apnea.|48 hours after delivery|The number analyzed per row differs from the overall number because the analysis was distinguished down by type of delivery and upper body position. Thus, 20 patients belong to each group as seen below.|||units on a scale||Inter-Quartile Range|Median
2586682|NCT02330055|Secondary|Minimal & Mean SpO2|Basic pulseoximetry in the first night after delivery|48 hours after delivery||||percentage of hemoglobin in the blood||Inter-Quartile Range|Median
2586683|NCT02330055|Secondary|Oxygen Desaturation Index > 3|ODI (oxygen desaturation index), assessed by pulse oximetry during the first night after delivery. ODI is defined as number of desaturation events per hour; a desaturation event is defined as drop in SpO2 of 3% or more from baseline SpO2. Baseline SpO2 is defined as the mean SpO2 of the SpO2 values taken over the preceding 120 seconds.|48 hours after delivery||||1/hr||Inter-Quartile Range|Median
2586684|NCT02330055|Primary|SpO2 < 90%|Oxygen Saturation (SpO2) value below 90%, assessed by pulse oximetry during the first night after delivery|48 hours after delivery||||minutes||Inter-Quartile Range|Median
2586685|NCT02329964|Secondary|Time to Eye Opening|We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to opening of the eyes to verbal commands.|from end of surgery to opening of the eyes to verbal commands||||seconds||Inter-Quartile Range|Median
2586686|NCT02329964|Secondary|Time to First Spontaneous Breath|time from end of surgery to first spontaneous breaths|from end of surgery to first spontaneous breaths||||seconds||Inter-Quartile Range|Median
2586687|NCT02329964|Primary|Recovery of T1 to 10%|we measure the time from the end of surgery to recovery of the TOF 0.1. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed.|from the end of surgery to time when the TOF ratio is 0.1, up to 30 minutes||||seconds||Inter-Quartile Range|Median
2586688|NCT02329964|Other Pre-specified|Anesthesia Time|time from propofol injection to extubation|from the anesthesia start to end||||minutes||Standard Deviation|Mean
2586689|NCT02329964|Other Pre-specified|Length of Stay in te Operating Room|LMS surgery has short operation time and ambulatory setting. So the length of stay in the operating room will have significant. We expected the lengh of stay in the operating room is more shorter in R-S group than S-C-N group.|time from in to out of the operating room||||minutes||Standard Deviation|Mean
2586690|NCT02329964|Secondary|Time to Extubation|We expected the emergence time is shorter in R-S group than S-C-N group. So we measure the time from the end of surgery to recovery of the TOF 0.9, and the time from the end of surgery to extubation|from the end of surgery to extubate a tracheal tube||||seconds||Inter-Quartile Range|Median
2586691|NCT02329964|Primary|Addition of Neuromuscular Blocking Agents|"Repeated small boluses or drip of Succinylcholine, or small boluses of nondepolarizing muscle relaxants with intermediate duration are usually followed.~In this protocol, cisatracurium was injected after intubation to maintain neuromuscular blockade during surgery.~We measure the requirement of additive dose of neuromuscular blocker to ensure that neuromuscular blockade remains below T2 during surgery"|during surgery||||participants|||Number
2586692|NCT02329964|Primary|Surgical Rating Score|"describe by surgeon under his subjective opinion.~1 - extremely poor conditions 2- poor conditions 3- acceptable conditions 4- good conditions 5- optimal conditions"|during surgery||||score||Inter-Quartile Range|Median
2586693|NCT02329964|Primary|Recovery of T1 to 90%|we measure the time from the end of surgery to recovery of the TOF 0.9. The end of surgery is defined as the time when the direct laryngoscope, aided by an operation microscope, is removed.|from the end of surgery(when the surgeon removes the suspension laryngoscope ) to time when the TOF ratio is 0.9, up to 30 minutes||||seconds||Inter-Quartile Range|Median
2586696|NCT02329730|Primary|Number of Tuberculosis (TB) Participants Positive for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 96 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.|96 hours after intradermal injection|The percentage of positive(positive number/total number*100%) is the sensitivity of ESAT6-CFP10 .|||participants|||Number
2586697|NCT02329730|Primary|Number of Healthy Participants Negative for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 96 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.|96 hours after intradermal injection|The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10 .|||participants|||Number
2586698|NCT02329730|Primary|Number of Tuberculosis (TB) Participants Positive for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 72 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.|72 hours after intradermal injection|The percentage of positive(positive number/total number*100%) is the sensitivity of ESAT6-CFP10 .|||participants|||Number
2586699|NCT02329730|Primary|Number of Healthy Participants Negative for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP10|"The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 72 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.~The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10"|72 hours after intradermal injection||||participants|||Number
2586700|NCT02329730|Primary|Number of Tuberculosis (TB) Participants Positive for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 48 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.|48 hours after intradermal injection|The percentage of positive(positive number/total number*100%) is the sensitivity of ESAT6-CFP10.|||participants|||Number
2586701|NCT02329730|Primary|Number of Healthy Participants Negative for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 48 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.|48 hours after intradermal injection|The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10 .|||participants|||Number
2586702|NCT02329730|Primary|Number of Tuberculosis (TB) Participants Positive for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10|The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 24 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.|24 hours after intradermal injection|The percentage of positive(positive number/total number*100%) is the sensitivity of ESAT6-CFP10 .|||participants|||Number
2586703|NCT02329730|Secondary|the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) at 144 Hours After Intradermal Injection With ESAT6-CFP10|The investigator draw 5ml venous blood for detection of IFN-γ 144 hours before injection with drug.The percentage of positive(positive number/total number*100%) is the sensitivity of IFN-γ in in TB participants.|144 hours after injection||||participants|||Number
2586704|NCT02329730|Secondary|the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 144 Hours After Intradermal Injection With ESAT6-CFP10|The investigator draw 5ml venous blood for detection of IFN-γ 144 hours after injection with drug.The percentage of negative(negative number/total number*100%) is the specificity of IFN-γ in healthy participants.|144 hours after injection||||participants|||Number
2586705|NCT02329730|Secondary|the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP10|The investigator draw 5ml venous blood for detection of IFN-γ 72 hours after injection with drug.The percentage of positive(positivenumber/total number*100%) is the sensitivity of IFN-γ in in TB participants.|72 hours after injection||||participants|||Number
2586706|NCT02329730|Secondary|the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP10|The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug.The percentage of negative(negative number/total number*100%) is the specificity of IFN-γ in healthy participants.|72 hours after injection||||participants|||Number
2586707|NCT02329730|Secondary|the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) Before Injection|The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug. The percentage of positive(positive number/total number*100%) is the sensitivity of IFN-γ in TB Participants.|4 hours before injection and after signed ICF(informed consent forms)||||participants|||Number
2586708|NCT02329730|Secondary|the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) Before Injection|The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug.The percentage of negative(negative number/total number*100%) is the specificity of IFN-γ in healthy participants.|before injection and after signed ICF(informed consent forms)||||participants|||Number
2586709|NCT02329730|Secondary|the Number of Participants With Adverse Events|"evaluate specific time point of vital signs, skin test reaction, blood routine, urine routine, liver and kidney function, electrocardiogram and adverse events as the incidence of adverse events in the participants .~Skin test reaction observation time: at the end of the skin test, skin test after 15 minutes, 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 96 hours; Vital signs evaluation time: 0 minutes before the subjects were intradermal injection, intradermal injection after 15 minutes, 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 96 hours, 144 hours.~Blood routine, urine routine, liver and kidney function, electrocardiogram (ecg) evaluation time: skin test before and 144 h after injection; adverse events evaluation time: participants signed a written informed consent to finish all the follow-up."|before injection to 144 hours (plus or minus 2 hours) after injection||||participants|||Number
2586710|NCT02329730|Primary|Number of Healthy Participants Negative for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10|"The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 24 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.~The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10 ."|24 hours after intradermal injection|The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10 .|||participants|||Number
2586711|NCT02329600|Secondary|Salivary Total Oxidative Capacity|total oxidative capacity was assessed in whole unstimulated saliva by ezyme-linked immunosorbent assay (umol/L) at 1 month after treatment|one month after treatment||||umol/L||Standard Deviation|Mean
2586712|NCT02329600|Primary|Pain|pain was assessed by visual analogue scale (1-10) 1 indicates better and 10 worse, 1 month after treatment|one month after treatment||||units on a scale||Standard Deviation|Mean
2586713|NCT02329587|Secondary|Rates of Retention in Intervention|Number of randomized participants who remained in the intervention phase of the study and completed all intervention sessions.|Approximately 6.5 weeks post-baseline||||Participants|||Count of Participants
2586714|NCT02329587|Secondary|Client Satisfaction Questionnaire-8: Total Score|The Client Satisfaction Questionnaire-8 is measure of client satisfaction. Scores can range from 8-32, with higher scores corresponding to greater satisfaction.|1-month follow up (Approximately 11 weeks after baseline assessment)|All available data for participants who completed the 1-month follow-up assessment|||units on a scale||Standard Deviation|Mean
2586715|NCT02329587|Secondary|Yale-Brown Obsessive-Compulsive Scale: Total Score|The Y-BOCS is a well-known measure for assessing OCD symptom severity. Total scores can range from 0-40, with higher scores corresponding to greater severity of symptoms.|1-month follow up (Approximately 11 weeks after baseline assessment)|All available data for participants who completed the 1-month follow-up assesment|||units on a scale||Standard Deviation|Mean
2586716|NCT02329587|Primary|Rates of Session Completion|Average number of intervention sessions completed|Approximately 6.5 weeks post-baseline||||Sessions||Full Range|Mean
2586717|NCT02329587|Primary|Client Satisfaction Questionnaire-8: Total Score|The Client Satisfaction Questionnaire-8 is measure of client satisfaction. Scores can range from 8-32, with higher scores corresponding to greater satisfaction.|Post-treatment (approximately 6.5 weeks post-baseline)|All participants with available data on outcome measure|||units on a scale||Standard Deviation|Mean
2586718|NCT02329587|Primary|Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Total Score|The Y-BOCS is a well-known measure for assessing OCD symptom severity. Total scores can range from 0-40, with higher scores corresponding to greater severity of symptoms.|Post-treatment (approximately 6.5 weeks post-baseline)|All participants with available data at the outcome timepoint|||units on a scale||Standard Deviation|Mean
2586719|NCT02329431|Secondary|Child Visit No-shows Over 4 Months|We collected child attendance at clinic visits during a 4-month window of time, during the 3-month period parents were participating in the study and one additional month following. Child clinic visit no-shows were measured by number of visits missed.|baseline to 4-month follow-up|Target child with any scheduled visits|||visits||Standard Deviation|Mean
2586720|NCT02329431|Secondary|Number of Clinic Visits Child Attended Over 4 Months|We collected child attendance at clinic visits during a 4-month window of time, during the 3-month period parents were participating in the study and one additional month following. Child clinic visit attendance was measured by number of visits attended.|baseline to 4-month follow-up|Target child with any scheduled clinic visits|||visits||Standard Deviation|Mean
2586721|NCT02329431|Secondary|Parent Activation, Qualitative|We collected qualitative data on parent-provider communication after completion of the 4-week MePrEPA (metas, preguntar, escuchar, preguntar para aclarar/goals, questioning, listening, questioning to clarify) and parent support groups, in an effort to capture observed activation. We coded when the parent disagreed with therapist and when the parent mentioned speaking with child's teacher.|1 month|Completed baseline interview and had an audio-recorded visit|||Participants|||Count of Participants
2586722|NCT02329431|Secondary|Parental Stress Scale|Parent stress was measured with the 17-item Parental Stress Scale. The Parental Stress Scale is scored on a scale from 0 to 75, where higher scores reflect greater stress. It has been translated into Spanish, and has been shown to have excellent validity and reliability (for women, mean=22).|1 and 3 months|Completed a baseline interview|||scores on a scale||Standard Deviation|Mean
2586723|NCT02329431|Secondary|8-item Patient Health Questionnaire (PHQ-8)|Parent depression was measured with the 8-item Patient Health Questionnaire (PHQ-8). The PHQ-8 is scored on a scale from 0 to 27; a higher score reflects greater severity of depression. It has excellent validity and reliability. The parent PHQ-9 has been translated into Spanish and used successfully in Latina/o populations. A change of 5 points in the PHQ-8 is associated with a shift in level of depression.|1 and 3 months|Completed a baseline interview|||scores on a scale||Standard Deviation|Mean
2586743|NCT02328807|Secondary|Number of Participants With Treatment Related Adverse Events|The type of event using NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0 will be identified and graded for severity. The relationship of the adverse event to the therapy or procedure will be determined as follows: Unrelated; Unlikely; Possible; Probable; Definite. For reporting purposes, an adverse event is considered unexpected when either the type of event or severity of the event is not listed in the study consent.|Up to 9 months|All participants.|||Participants|||Count of Participants
2586724|NCT02329431|Primary|Patient Activation Measure|The Patient Activation Measure (PAM) captured parent activation on behalf of their child. The PAM is an adult self-report 13-item scale with 4-level Likert responses and scores ranging from 0 to 100. Higher scores indicate higher activation. It is valid with excellent reliability. The PAM has been translated into Spanish and has been used successfully in Latina/o patient and general populations (mean=40). The PAM has also been used to measure activation of parents on behalf of their children (mean=70). A change of 4 points in the PAM is associated with improved health behaviors in the general population.|1 and 3 months|Completed a baseline interview|||scores on a scale||Standard Deviation|Mean
2586725|NCT02329223|Secondary|Percentage of Participants With Production of Anti-omalizumab Antibody|Serum samples were collected for anti-omalizumab antibody testing.|Week 24|The safety analysis set, which included all participants who received their assigned study treatment, were considered for the analysis. Only participants, who had antibody results (conclusive or inconclusive), were analyzed.|||Percentage of participants|||Number
2586726|NCT02329223|Secondary|Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI is a 10-item dermatology-specific health-related quality of life measure. Participants rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score from baseline indicates improvement.|Baseline to Week 12|Only participants from the FAS, who were greater than age 16, were analyzed. The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.|||Units on a scale||Standard Error|Least Squares Mean
2586727|NCT02329223|Secondary|Percentage of Complete Responders (UAS7 = 0) at Week 12|Complete responders are defined as participants who achieved UAS7 = 0.|Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.|||Percentage of participants|||Number
2586728|NCT02329223|Secondary|Percentage of Weekly Itch Severity Score Minimally Important Difference (MID) Responders at Week 12|Weekly itch severity score MID response is defined as a reduction from baseline in weekly itch severity score of ≥ 5 points.|Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.|||Percentage of participants|||Number
2586729|NCT02329223|Secondary|Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12|The weekly size of the largest hive score is the sum of the daily size of the largest hive scores over 7 days and ranges from 0 to 21. The daily size of the largest hive score is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily size of the largest hive score is the average of the morning and evening scores. The Baseline weekly size of the largest hive score is calculated over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score from baseline indicates a reduction in hive size.|Baseline to Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.|||Units on a scale||Standard Error|Least Squares Mean
2586730|NCT02329223|Secondary|Percentage of Participants With a UAS7 Score ≤ 6 at Week 12|The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms.|Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.|||Percentage of participants|||Number
2586731|NCT02329223|Secondary|Change From Baseline in the Weekly Number of Hives Score at Week 12|The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement.|Baseline to Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.|||Units on a scale||Standard Error|Least Squares Mean
2586732|NCT02329223|Secondary|Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12|The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The UAS7 is determined by the sum of the daily urticaria activity scores over 7 days and ranges from 0 to 42. The daily urticaria activity score is the average of the morning and evening urticaria activity scores and ranges from 0 to 6. The urticaria activity score is the sum of ratings on a scale of 0 to 3 (0=none to 3=intense/severe) for (1) the number of wheals (hives) and (2) itch intensity over the previous 12 hours, ranges from 0 to 6, and is measured twice daily (morning and evening). The Baseline score is the sum of the daily urticaria activity scores over the 7 days prior to the first treatment. A higher urticaria activity score indicates more severe symptoms. A negative change score from baseline indicates improvement.|Baseline to Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria (CSU) and received the assigned study treatment.|||Units on a scale||Standard Error|Least Squares Mean
2586744|NCT02328807|Primary|Negative Biopsy Rate at 6 Months After Focal Bipolar Radio-Frequency Ablation (RFA)|The primary efficacy endpoint is negative biopsy rate at 6 months after focal bipolar RFA. The point estimate and its 95% confidence interval will be calculated using the exact binominal method.|6 months|All participants.|||Participants|||Count of Participants
2587437|NCT02318940|Primary|Installation on the First Try|Percentage of Participants with successful installation on the first transcutaneous passage of the glass needle|intraoperative, an average of 1 hour||||percentage of participants|||Number
2586733|NCT02329223|Primary|Change From Baseline in the Weekly Itch Severity Score at Week 12|The weekly itch severity score is a component of the Urticaria Activity Score 7 (UAS7) composite score. The UAS7 is a composite score of the number of wheals (hives) and the severity of the itch. The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score from baseline indicates improvement.|Baseline to Week 12|The Full Analysis Set (FAS) was analyzed. The FAS included all participants who were diagnosed with chronic spontaneous urticaria(CSU) and received the assigned study treatment.|||Units on a scale||Standard Error|Least Squares Mean
2586734|NCT02329015|Other Pre-specified|Teacher Report Behavior Rating Inventory of Executive Function|Teacher reported 87 item questionnaire on students executive function and self regulation. The BRIEF for teachers measures 8 non-overlapping theoretically and empirically derived clinical scales that measure different aspects of executive functioning with the Inhibit, Shift, Emotional control and Monitor subscales combining to create a Behavioral Regulation Index (BRI) and the Working Memory, Plan/Organize, Organization of Materials and Task Completion combining to create a Meta Cognition Index. These two indices combine to create a Global Executive Composite (GEC). Only the GEC was used within this study for analysis Raw scores were converted to T scores (using gender and age for population norms) wherein a score of 50 represents the mean and a difference of 10 from the mean indicates a difference of one standard deviation.|One year|3 subjects missing from experimental group and 5 subjects missing from comparison group|||units on a scale||Standard Deviation|Mean
2586735|NCT02329015|Other Pre-specified|Student Self-Report Behavior Rating Inventory of Executive Function|An 80 item self-report questionnaire assessing executive function and self regulation. The BRIEF-SR measures 8 non-overlapping clinical scales that measure different aspects of executive functioning with the Inhibit, Shift, Emotional control and Monitor subscales combining to create a Behavioral Regulation Index (BRI) and the Working Memory, Plan/Organize, Organization of Materials and Task Completion combining to create a Meta Cognition Index. These two indices combine to create a Global Executive Composite (GEC). Only the GEC was used within this study for analysis. Raw scores were converted to T scores (using gender and age for population norms) wherein a score of 50 represents the mean and a difference of 10 from the mean indicates a difference of one standard deviation.|1 year|9 subjects missing from experimental group and 9 subjects missing from comparison group|||units on a scale||Standard Deviation|Mean
2586736|NCT02329015|Other Pre-specified|Self Report Questionnaire (Child and Adolescent Mindfulness Measure)|A 10 item self-report measure assessing mindfulness skills (Scale 1-4). Items are reverse scored and summed (not mean). Higher scores mean more positive mindfulness skills. Min and maximum scores are 0-40.|1 year|9 subjects missing from experimental group and 11 subjects missing from comparison group|||units on a scale||Standard Deviation|Mean
2586737|NCT02329015|Secondary|Warwick Edinburgh Mental Well Being Scale|A 14 item self-report measure assessing subjective well-being (1-5 scale). Higher values represent more positive mental well being. The summary measure is a sum of the 14 questions (not a mean). Summary values therefore range from 14-70.|1 year|9 subjects missing from experimental group and 11 subjects missing from comparison group|||units on a scale||Standard Deviation|Mean
2586738|NCT02329015|Secondary|Response to Stress Questionnaire (RSQ)|A 57-item self-report questionnaire that was used as a measure of emotional regulation We examined two of the five constructs (24 of the 57 items) within the RSQ as these were most directly theoretically relevant to expected changes due to yoga practice: voluntary engagement and involuntary engagement. Higher values represent higher levels of negative stress responses. Values for the voluntary engagement subscale represent the mean value across 9 questions on the survey and values for the involuntary subscale represent the mean value across 15 questions on the survey. Values for each item range from 0-3, trherefore the total mean values reported as outcomes range from 0-3.|1 year|Missing data: 2 from experimental group, none from control group|||units on a scale||Standard Deviation|Mean
2586739|NCT02329015|Primary|Academic Performance: Grade Point Averages|GPA was calculated as the numeric average of course scores of all courses taken by the student weighted by credit load of each course using a standard process within NYC public schools.|1 year|Intent to treat analysis. Data from all participants was available at baseline and at end of study.|||per cent||Standard Deviation|Mean
2586740|NCT02328937|Secondary|Limbal Redness|Limbal redness was assessed in both eyes using a slit lamp, 6-8 hours post lens insertion. Redness was assessed in 4 regions of the eye (nasal, temporal, inferior and superior) and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). For each region (nasal, temporal, inferior and superior) the average grade was calculated by lens. The Total Grade was then calculated by summing all the average grade for each region. The regional average grade ranges from 0 to 4. The total Grade ranges from 0 to 16.|6-8 hours post lens insertion|All subjects that were dispensed at least one study lens throughout the duration of this study.|||units on a scale||Standard Deviation|Mean
2586741|NCT02328937|Primary|Central Corneal Swelling|Corneal swelling measurements were taken in the right eye during slit lamp evaluations, 6-8 hours post lens insertion. The average corneal swelling per lens was reported.|6-8 Hours Post lens insertion|All subjects that were dispensed at least one study lens throughout the duration of the study.|||um||Standard Deviation|Mean
2586742|NCT02328807|Secondary|Completion of Quality of Life (QOL) Assessment Questionnaires at Six Months|The secondary objective is to evaluate the change from baseline in quality-of-life indicators following focal RFA in patients with low-risk localized prostate cancer. The patients will complete the Expanded Prostate Cancer Index Composite (EPIC), American Urological Association (AUA), Rectal Assessment Scale (RAS), and International Index of Erectile Function (IIEF-5) questionnaires at baseline and 6-month visit. EPIC scores overall 1 (dissatisfied) - 5 (extremely satisfied). AUA scores are o (no prostate issues) - 35 (very severe prostate symptoms). SHIM scores 0 (severe sexual dysfunction) - 25 (no sexual dysfunction) and RAS scores 0 (no bowel issues) - 15 (bad bowel habits)|6 months||||score on a scale||Full Range|Median
2587041|NCT02324205|Secondary|Lesion Type Observed by DBT Imaging|Lesions were characterized based on findings identified during image evaluations performed by qualified researchers.|Approximately 8 weeks|Participants with DBT breast images collected, and lesion characteristic described by qualified reader. Participants may have more than one lesion.|||lesions|lesions||Number
2586745|NCT02328547|Secondary|Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)|"Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial.~Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed. Information on abundance of Prevotella was only available at baseline and week 1."|Baseline and Week 1||||percentage of bacteria||Standard Deviation|Mean
2586746|NCT02328547|Secondary|Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)|"Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial.~Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed."|Baseline, Week 1, Week 4 and Week 12||||percentage of bacteria||Standard Deviation|Mean
2586747|NCT02328547|Secondary|Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)|"Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial.~Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed.~The Beta Diversity Index or Jensen-Shannon divergence is a quantitative measure that reflects the diversity of bacterial species between two different regions. The greater the index, the more diverse the intestinal microbiota between the two regions."|Baseline, Week 1, Week 4 and Week 12||||index||Standard Deviation|Mean
2586748|NCT02328547|Secondary|Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)|"Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial.~Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed.~The Alpha Diversity Index is a quantitative measure that reflects the diversity of bacterial species in a sample. The greater the index, the more diverse the intestinal microbiota."|Baseline, Week 1, Week 4 and Week 12||||index||Standard Deviation|Mean
2586749|NCT02328547|Secondary|Tolerability of Fecal Microbiota Transplantation (FMT)|Tolerability of Fecal Microbiota Transplantation (FMT) will be maintained in patient diaries.|Week 12 following administration of FMT|Data was not collected and, therefore, the outcome cannot be reported.||||||
2586750|NCT02328547|Secondary|Patient Attitudes Towards Fecal Microbiota Transplantation (FMT)|Patient attitudes towards Fecal Microbiota Transplantation (FMT) will be recorded in patient diaries.|Week 12 following administration of FMT|Data was not collected and, therefore, the outcome cannot be reported.||||||
2586751|NCT02328547|Secondary|Initiation of New Medications Post-FMT for the Treatment of IBS-D Symptoms|Initiation of new medications post-FMT for the treatment of IBS-D symptoms will be recorded in patient diaries.|Week 12 following administration of FMT|Data was not collected and, therefore, the outcome cannot be reported.||||||
2586752|NCT02328547|Secondary|Number of Doctor or Emergency Department (ED) Visits Post-Fecal Microbiota Transplantation (Post-FMT) for Irritable Bowel Syndrome-D (IBS-D) Related Symptoms|The number of doctor or ED visits post-Fecal Microbiota Transplantation for Irritable Bowel Syndrome-D (IBS-D) related symptoms will be recorded in patient diaries.|Week 12 following administration of FMT|Data was not collected and, therefore, the outcome cannot be reported.||||||
2586753|NCT02328547|Secondary|Change in Bowel Habits and Abdominal Pain After Fecal Microbiota Transplantation (FMT)|Degree of improvement in bowel habits and abdominal pain will be recorded in patient diaries.|Week 12 following administration of FMT|Data was not collected and, therefore, the outcome cannot be reported.||||||
2586754|NCT02328547|Secondary|Satisfaction With Fecal Microbiota Transplantation (FMT)|Weekly assessments of satisfaction with the Fecal Microbiota Transplantation (FMT) will be recorded in patient diaries.|Week 12 following administration of FMT|Data was not collected and, therefore, the outcome cannot be reported.||||||
2586755|NCT02328547|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The total number of participants in each of the arms/groups (FMT and Placebo) who experienced at least one adverse event (AE) as recorded in patient diaries.|All AEs over 24 weeks|Participants were randomized to FMT first followed by placebo (n=25) OR to placebo first followed by FMT (n=23) and analyzed in these groups. Participants who received FMT 1st and those who received FMT 2nd were pooled together into one group.|||Participants|||Count of Participants
2586771|NCT02328404|Secondary|Serum Parathyroid Hormone Concentration|"Evaluation of the Safety of the Dose and the Dose Regimen as Per the SmPC by measuring the change in the level of serum Serum Parathyroid Hormone (PTH) Concentration before and after the treatment and/or reporting any adverse events through the trial period.~In this measure , Serum Parathyroid Hormone Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms."|3 months||||Pg/ml||Standard Error|Mean
2586756|NCT02328547|Secondary|Bowel Consistency as Measured by the Bristol Stool Form Scale (BSFS)|"Bowel consistency as measured by the Bristol Stool Form Scale on a daily basis.~The Bristol Stool Form Scale was administered via questionnaire. This scale is a diagnostic medical tool designed to classify the form of human feces into seven categories. Assigned categories range from 1-7 based on appearance of the stool. Type 1 and 2 stools indicate constipation. Type 4 are the ideal stools as they are easy to defecate while not containing excess liquid, Type 5 tends towards diarrhea, and Types 6 and 7 indicate diarrhea.~Only the following time points were analyzed: Baseline vs Week 12"|Baseline, Week 12 (before cross-over), Week 24|Participants were randomized to FMT first followed by placebo (n=25) OR to placebo first followed by FMT (n=23) and analyzed in these groups. Participants who received FMT 1st and those who received FMT 2nd were not pooled together into one group because of potential carry-over effects. As such, data for crossover intervention couldn't be reported.|||score on a scale||Standard Deviation|Mean
2586757|NCT02328547|Secondary|Depression as Measured by the Hospital Anxiety and Depression Scale (HADS). HADS-D (Depression)|"Depression at baseline and at the time of cross-over (Week 12) as measured by Hospital Anxiety and Depression Scale (HADS). HADS-D (Depression)~The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale which was administered via questionnaire. Seven of the items relate to anxiety (HADS-A) and seven relate to depression (HADS-D). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. Higher HADS scores are indicative of more severe depression and anxiety.~Only the following time points were analyzed: Baseline vs Week 12"|Baseline, Week 12 (before cross-over), Week 24|Participants were randomized to FMT first followed by placebo (n=25) OR to placebo first followed by FMT (n=23) and analyzed in these groups. Participants who received FMT 1st and those who received FMT 2nd were not pooled together into one group because of potential carry-over effects. As such, data for crossover intervention couldn't be reported.|||score on a scale||Standard Deviation|Mean
2586758|NCT02328547|Secondary|Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS). HADS-A (Anxiety)|"Anxiety at baseline and at the time of cross-over (Week 12) as measured by Hospital Anxiety and Depression Scale (HADS). HADS-A (Anxiety)~The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale which was administered via questionnaire. Seven of the items relate to anxiety (HADS-A) and seven relate to depression (HADS-D). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. Higher HADS scores are indicative of more severe depression and anxiety.~Only the following time points were analyzed: Baseline vs Week 12"|Baseline, Week 12 (before cross-over), Week 24|Participants were randomized to FMT first followed by placebo (n=25) OR to placebo first followed by FMT (n=23) and analyzed in these groups. Participants who received FMT 1st and those who received FMT 2nd were not pooled together into one group because of potential carry-over effects. As such, data for crossover intervention couldn't be reported.|||score on a scale||Standard Deviation|Mean
2586759|NCT02328547|Secondary|Intestinal Microbiota Composition Pre- and Post-FMT (Fecal Microbiota Transplantation)|"Microbiota composition before and after FMT were assessed among FMT responders and FMT non-responders. Only patients who received FMT capsules at the start of this clinical trial were included. Placebo capsule recipients were not included in these analyses. Data were analyzed up to 12 weeks and not beyond. Microbiome data following cross-over were not analyzed because of the potential for carry-over and order effects in the second half of the trial.~Outcomes assessed included alpha and beta diversity (Jensen-Shannon divergence) and abundance of Bacteroidetes, Firmicutes and Prevotella. All of the microbiome data that were analyzed are included in the table below. No additional microbiome data from this clinical trial were analyzed."|Baseline, Week 1, Week 4 and Week 12||||percentage of bacteria||Standard Deviation|Mean
2586760|NCT02328547|Secondary|Within and Between Group Comparisons of Quality of Life as Determined by the Irritable Bowel Syndrome-Quality of Life (IBS-QOL) Score|"Within and between group comparisons of changes (from baseline) in Irritable Bowel Syndrome-Quality of Life (IBS-QOL), obtained via administration of a Questionnaire, for each of the two arms/groups (FMT capsules first, and placebo capsules first). Irritable Bowel Syndrome-Quality of Life (IBS-QOL) is administered via a questionnaire of 34 items each with an individual five-point response scale. The responses to these items are summed and averaged for a total score and then transformed to a 100-point scale for ease of interpretation based on a validated method. IBS-QOL is measured on a scale range of 0-100. Higher IBS-QOL scores are indicative of a better IBS-specific quality of life.~Only the following time points were analyzed: Baseline vs Week 12"|Baseline, Week 12 (before cross-over), Week 24|Participants were randomized to FMT first followed by placebo (n=25) OR to placebo first followed by FMT (n=23) and analyzed in these groups. Participants who received FMT 1st and those who received FMT 2nd were not pooled together into one group because of potential carry-over effects. As such, data for crossover intervention couldn't be reported.|||units on a scale||Standard Deviation|Mean
2586761|NCT02328547|Primary|Within and Between Group Comparisons of Disease Severity as Determined by Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS)|"Within and between group comparisons of changes (from baseline) in Irritable Bowel Syndrome-Symptom Severity Score (IBS-SSS), obtained via administration of a Questionnaire, for each of the two arms/groups (FMT capsules first, and placebo capsules first). The scale range was 0-500 (min-max). Scores were averaged among time points to yield an overall mean score. Higher scores were indicative of greater disease severity (worse outcome). Subjects were categorized as having mild (75-175), moderate (175-300), or severe (>300) irritable bowel syndrome (IBS) based on symptomology.~Only the following time points were analyzed: Baseline vs Week 12 and Week 24."|Baseline, Week 12 (before cross-over), Week 24|Participants were randomized to FMT first followed by placebo (n=25) OR to placebo first followed by FMT (n=23) and analyzed in these groups. Participants who received FMT 1st and those who received FMT 2nd were not pooled together into one group because of potential carry-over effects.|||units on a scale||Standard Deviation|Mean
2586819|NCT02327260|Primary|Adherence (Ratio): Statin|A continuous single-interval medication availability ratio was calculated by dividing the number of days supplied by a pharmacy fill by the number of days before the next pharmacy fill for the same medication. A higher ratio was indicative of greater adherence.|Collected at 5 weeks post-discharge|We are missing data because some pharmacies did not respond to our requests.|||adherence ratio||Standard Deviation|Mean
2586762|NCT02328404|Primary|Sex Hormone Binding Globulin Concentration|"Evaluation of Biodal 50,000 IU on improvement of PCOS Prognosis by comparing the Sex Hormone Binding Globulin concentrations in both groups/arms.~One of the clinical signs of improving PCOS prognosis is the change in the Sex Hormone Binding Globulin Concentration.~In this measure , the Sex Hormone Binding Globulin Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms.~The results will be statistically analyzed using Wilcoxon (Mann-Whiteny) method at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months||||nmol/L||Standard Deviation|Mean
2586763|NCT02328404|Primary|Free Androgen Index|"Free Androgen Index is calculated as the ratio of total testosterone to sex hormone binding globulin (SHBG).~In this measure , the Free Androgen Index in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms.~Improvement assessment of PCOS Prognosis by evaluating the change in Free Androgen Index.~One of the clinical signs of improving PCOS prognosis is the change in FAI. the results will be statistically analyzed using Wilcoxon (Mann- Whitney) method at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months||||Ratio||Standard Deviation|Mean
2586764|NCT02328404|Primary|Total Testosterone Level|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS Prognosis by measuring Change in Total Testosterone level before and after the treatment.~In this measure , the Total Testosterone levels in each arm were reported after completing the course of the treatment / intervention as per the study protocol.~One of the clinical signs of improving PCOS prognosis is the change in testosterone level. After which, the means were compared for statistical significance between the two groups / arms.~the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months||||nmol/L||Standard Deviation|Mean
2586765|NCT02328404|Primary|Serum Progesterone Level|"The results below show the Serum Progesterone level after treatment in each arm after completing the course of the treatment / intervention as per the study protocol.after which, the means were compared for statistical significance between the two groups / arms. After which, the means were compared for statistical significance between the two groups / arms.~The evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS Prognosis by measuring Change in Serum Progesterone level.~One of the clinical signs of improving PCOS prognosis is the change in progesterone level. the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months||||nmol/L||Standard Error|Mean
2586766|NCT02328404|Secondary|Serum C-Reactive Protien Concentration|"Evaluation of the Efficacy of the Dose (50,000IU) and the Dose Regimen on inflammation by measuring reduction of the serum concentration of C-Reactive Protein before and after the treatment.~In this measure , Serum C-Reactive Protien Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms."|3 months||||mg/L||Standard Error|Mean
2586767|NCT02328404|Primary|Hirsutism Score|"The scale ranges between 0 and 36, where A score of 8 or higher was considered as androgen excess (Ferriman and Gallwey, 1961).Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on PCOS prognosis by evaluating Hirsutism Score.Hirsutism score was assessed using self-administrated Ferriman-Gallwey scoring system (Ferriman and Gallwey, 1961). Each participant answered the hirsutism test with the help of a trained nurse who was working in the same clinic. The score of each body site may range between 0 (no excessive terminal hair growth) to 4 (extensive terminal hair growth).~In this measure , the hirsutism score were reported in each are after completing the course of treatment/ intervention as per the study protocol. after which, the means were compared for statistical significance between the two groups / arms."|3 months||||units on a scale||Standard Error|Mean
2586768|NCT02328404|Secondary|Serum Phosphorous Concentration|"Evaluation of the safety of the dose and the dose regimen as per the SmPC by measuring the change in the level of serum PO4 Concentration before and after the treatment and/or reporting as adverse event through the trial period.as the increase of Serum phosphoruse concentration above the normal level is considered as adverse event for the intervention dose regimen of this study for the purpose of evaluating the safety.~In this measure , Serum Phosphorous Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms."|3 months||||mmol/L||Standard Error|Mean
2586769|NCT02328404|Secondary|Serum Calcium Concentration|"Evaluation of the safety of the dose and the dose regimen as per the SmPC by measuring the change in the level of serum Calcium before and after the treatment and/or reporting it as adverse. event through the trial period. as the increase of Serum calcium concentration above the normal level is considered as adverse event for the intervention dose regimen of this study for the purpose of evaluating the safety.~In this measure , Serum Calcium Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms."|3 months||||mmol/L||Standard Error|Mean
2586770|NCT02328404|Primary|Menstrual Regularity|"Evaluation of the efficacy of the dosing regimen as per the approved SmPC (50,000 IU vitamin D3 once weekly for 3 months) on improvement in PCOS prognosis by assessment of menstrual regularity An improvement in PCOS prognosis by assessment of menstrual regularity is measured through improving progesterone level > 4 ng/mL.~One of the clinical signs of improving PCOS prognosis is menstrual cycle regularity.~In this measure ,the reported results consist of the number of volunteers/patients in each arm either with regular menstrual cycle or irregular menstrual cycle after completing the course of the treatment/ intervention as per the study protocol.~The results will be statistically analyzed using paired student t-test and 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months||||participants|||Number
2605729|NCT02107014|Primary|Change in CD40L From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2586772|NCT02328404|Secondary|Body Mass Index|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction of body mass index to be <25-30 kg/m^2.~Evaluation of the Effectiveness of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction in Body Mass Index before and after the treatment. After which, the means were compared for statistical significance between the two groups / arms.~In this measure , Body Mass Index in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months)."|3 months||||kg/m^2||Standard Error|Mean
2586773|NCT02328404|Secondary|Serum Glucose Concentration in Oral Glucose Tolerance Test 1st hr After Treatment|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on reduction of insulin resistance and improving insulin sensitivity measuring Oral Glucose Tolerance Test 1st hr after the treatment and to compare with same at baseline point within the time frame.~In this measure , Serum Glucose Concentration in Oral Glucose Tolerance test in each arm were reported after completing the course of the treatment / intervention as per the study protocol (Treatment with either Biodal or Placebo for 3 months). After which, the means were compared for statistical significance between the two groups / arms.~One of the clinical signs of improving PCOS prognosis is the improvement in insulin resistance by evaluating the results of Oral Glucose Tolerance Test 1st hr . the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI)."|3 months||||mmol/L||Standard Error|Mean
2586774|NCT02328404|Secondary|Serum Chromium Concentration|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on improving serum chromium level to be > 0.05 and < 0.5 ppm. which will be assessed by measuring serum chromium level before and after supplementation of Vitamin D3.~In this measure , Serum chromium Concentration in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms.~One of the clinical signs of improving PCOS prognosis is the improvement in serum chromium level . the results will be statistically analyzed using paired student t-test at 95% confidence interval (CI) for the difference of the means within and between the two groups will be calculated."|3 months||||ppm||Standard Error|Mean
2586775|NCT02328404|Secondary|Serum 25-Hydroxy Vitamin D3 Level|"Evaluation of the Efficacy of the dose (50,000IU) and the dose regimen as per the approved SmPC on increase the level of serum 25(OH)D > 20 ng/ml by measuring of the serum 25(OH)D levels on 104 of the study period after 3 months treatment .~In this measure , Serum 25-Hydroxy Vitamin D3 leveln in each arm were reported after completing the course of the treatment / intervention as per the study protocol. After which, the means were compared for statistical significance between the two groups / arms."|3 months||||ng/ml||Standard Error|Mean
2586776|NCT02328404|Primary|Ultrasound Examination of Number of Follicles and Ovarian Volume|"Evaluation of the efficacy of the dosing regimen as per the approved Summery of Product Characteristics (SmPC) (50,000 IU vitamin D3 once weekly for 3 months) on improvement in PCOS prognosis clinically using ultrasound examination.~In this measure the reported results were the finding of the ultrasound examination after the course of the treatment /intervention as per the study protocol and reporting the numbers of patients with normal ovaries, One normal ovary and the other is polycystic or both ovaries are poly-cystic.~An improvement in PCOS prognosis clinically by ultrasound examination is defined by:~decreasing the number of follicles to < 12 follicles measuring 2-9 mm in diameter~decreasing ovarian volume to < 10 cm3"|3 months|The participants in the treatment and placebo groups will be classified into two categories of prognosis (improved and not improved) and will be analyzed using Chi-square test, if Chi-square is higher than 3.84 (df=1) it will be statistically significant (p-value</= 0.05)|||participants|||Number
2586777|NCT02328105|Secondary|Duration of Disease Control|For subjects who achieve SD or better, duration of disease control will be measured from the treatment start date until the day on which progressive disease (PD) or death occurred. The censoring method will be the same as that described for PFS.|From date of treatment start to date of progression, or censored as described above.||2020-11-30|11/2020||||
2586778|NCT02328105|Secondary|Duration of Response|For subjects who achieve a CR or PR, response duration will be measured from the first day of the response until the day on which progressive disease (PD) or death occurred. The censoring method will be the same as that described for PFS.|From date of response to date of progression/death, or censored as described above.||2020-11-30|11/2020||||
2586779|NCT02328105|Secondary|Overall Survival|OS is defined as the duration of time from treatment start date to the date of death from any cause. Subjects who are alive or lost to follow-up at the time of the analysis will be censored at the last known date they were alive.|From date of treatment start to date of death, or censored as described above.||2020-11-30|11/2020||||
2586780|NCT02328105|Secondary|Progression Free Survival|PFS is defined as the duration of time from treatment start date to time of progression or death. Disease progression may be determined objectively as per RECIST 1.1 or subjectively as determined by the investigator. Evidence for subjective progressions must be documented in the eMR. For objective disease progression, date of PD is date of the radiologic assessment that identified RECIST-defined progressive disease. For subjective disease progression, date of PD is the date that the clinician makes the determination of disease progression. If the subject died without documented disease progression, date of progression will be date of death. For surviving subjects who do not have objectively documented disease progression, PFS will be censored at the date of last radiologic assessment. For subjects who receive subsequent anti-cancer therapy prior to documented disease progression, PFS will be censored at date of last radiologic assessment prior to commencement of subsequent therapy.|From date of treatment start to date of progression/death, or censored as described above.||2020-11-30|11/2020||||
2586781|NCT02328105|Secondary|Number of Subjects With Stable Disease or Response|Disease control is calculated for each subject indicating whether or not they achieved an overall response of stable disease or better by RECIST 1.1 (where a CR is indicated by disappearance of all target and non target lesions, a PR is indicated by >= 30% decrease in sum of longest diameter of target lesions with baseline as reference, and SD is neither sufficient shrinkage to qualify for PR nor sufficient growth, >=20%, to indicate progression).|18 weeks|The efficacy population (or evaluable population) is defined as all subjects who have measurable disease present at baseline, have received at least one dose of study therapy, and have had their disease re-evaluated (either clinically or radiographically).|||Participants|||Count of Participants
2605730|NCT02107014|Primary|Change in TRAIL From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2586782|NCT02328105|Primary|Number of Participants With a Response|The primary endpoint is a binary variable determined for each patient indicating whether or not they achieved a complete response (CR) or a partial response (PR) as per RECIST 1.1 (where a CR is indicated by disappearance of all target and non target lesions and a PR is indicated by >= 30% decrease in sum of longest diameter of target lesions with baseline as reference). Because overall response is the primary endpoint for this study, best responses of CR or PR must be confirmed by a subsequent radiologic assessment.|Up to a planned 18 weeks|The efficacy population (or evaluable population) is defined as all subjects who have measurable disease present at baseline, have received at least one dose of study therapy, and have had their disease re-evaluated (either clinically or radiographically)|||Participants|||Count of Participants
2586783|NCT02328040|Secondary|Measure of Glucagon Concentration in Subjects Treated With Sitagliptin, Compared to Placebo|Serum glucagon concentrations were measured in the CL setting in the treatment arm, sitagliptin, compared to the placebo (Insulin monotherapy)|18 months||||Pmol/L||Standard Deviation|Mean
2586784|NCT02328040|Primary|Blood Glucose Measures in Subjects Treated With Sitagliptin, Compared to the Placebo|Better targeted blood glucose levels in the CL setting in the treatment arm, Sitagliptin, compared to placebo (insulin monotherapy)|18 Months||||mg/dl||Standard Deviation|Mean
2586785|NCT02327741|Secondary|Tolerability - the Number of Patients , Who Are Able to Take Plavix Concerning Compliance and Economic Issues|the number of patients who are able to take plavix concerning compliance and economic issues|12 months||||Participants|||Count of Participants
2586786|NCT02327741|Primary|Number of Patients With Minor Bleeding|the number of patients with petechiae and superficial ecchymosis or nose bleeding need no admission or drug changes|12 months||||Participants|||Count of Participants
2586787|NCT02327741|Primary|Revascularization - Need for Redo Bypass Surgery and Redo Angioplasty|need for redo bypass surgery and redo angioplasty|12 months||||Participants|||Count of Participants
2586788|NCT02327741|Primary|Number of Patients With Death Due to Cardiac Causes|the number patients with death due to cardiac causes|12 months||||Participants|||Count of Participants
2586789|NCT02327741|Primary|Number of Patients With Central Vascular Accidents Proved by CT Scan|the number of patients with major vascular brain accidents ( CVA) proved by CT scan|12 months||||Participants|||Count of Participants
2586790|NCT02327741|Primary|Number of Patients With Myocardial Infarction Need Hospital Admission|The number of patients with myocardial infarction need hospital admission|12 month||||Participants|||Count of Participants
2586791|NCT02327741|Primary|Number of Patients With Major Bleeding Need Transfusion|number of patients with major bleeding need transfusion|12 months||||Participants|||Count of Participants
2586792|NCT02327429|Secondary|Change in Fasting High-density Lipoprotein Cholesterol|Fasting high-density lipoprotein cholesterol measured pre-post intervention from baseline to 3 months|12 weeks||||mg/dL||Standard Deviation|Mean
2586793|NCT02327429|Secondary|Change in Fasting Low-density Lipoprotein Cholesterol|Low-density lipoprotein cholesterol measured pre-post intervention from baseline to 3 months|12 weeks||||mg/dL||Standard Deviation|Mean
2586794|NCT02327429|Secondary|Change in Fasting Total Cholesterol|Fasting total cholesterol measured pre-post intervention from baseline to 3 months|12 weeks||||mg/dL||Standard Deviation|Mean
2586795|NCT02327429|Secondary|Change in Fasting Triglyceride|Fasting triglyceride measured pre-post intervention from baseline to 3 months|12 weeks||||mg/dL||Standard Deviation|Mean
2586796|NCT02327429|Secondary|Change in Waist Circumference|Waist circumference measured pre-post intervention from baseline to 3 months|12 weeks||||cm||Standard Deviation|Mean
2586797|NCT02327429|Secondary|Change in Body Mass Index (BMI)|Body mass index calculated from weight measured pre-post and height measured pre-intervention from baseline to 3 months|12 weeks||||kg/m2||Standard Deviation|Mean
2586798|NCT02327429|Secondary|Change in Hemoglobin A1c (A1c)|Hemoglobin A1c measured in capillary blood pre-post intervention from baseline to 3 months|12 weeks||||% of A1c in blood||Standard Deviation|Mean
2586799|NCT02327429|Primary|Change in Cholesterol Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months|12 weeks||||milligrams||Standard Deviation|Mean
2586800|NCT02327429|Primary|Change in Calcium Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months|12 weeks||||milligrams||Standard Deviation|Mean
2586801|NCT02327429|Primary|Change in Sodium Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record from baseline to 3 months|12 weeks||||milligrams||Standard Deviation|Mean
2586802|NCT02327429|Primary|Change in Added Sucrose Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks||||percentage of total energy||Standard Deviation|Mean
2586803|NCT02327429|Primary|Change in Dietary Fibre Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks||||grams||Standard Deviation|Mean
2586804|NCT02327429|Primary|Change in Saturated Fat Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks||||percentage of total energy||Standard Deviation|Mean
2586805|NCT02327429|Primary|Change in Total Fat Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks||||percentage of total energy||Standard Deviation|Mean
2586806|NCT02327429|Primary|Change in Protein Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks||||percentage of total energy||Standard Deviation|Mean
2586807|NCT02327429|Primary|Change in Carbohydrate Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks||||percentage of total energy||Standard Deviation|Mean
2586808|NCT02327429|Primary|Change in Energy Intake (3-day Food Record)|Intake assessed pre-post intervention using a 3-day food record|12 weeks||||kcal||Standard Deviation|Mean
2586820|NCT02327260|Primary|Adherence (Ratio): Beta-Blocker|A continuous single-interval medication availability ratio was calculated by dividing the number of days supplied by a pharmacy fill by the number of days before the next pharmacy fill for the same medication. A higher ratio was indicative of greater adherence.|Collected at 5 weeks post-discharge|We are missing data because some pharmacies did not respond to our requests.|||adherence ratio||Standard Deviation|Mean
2586809|NCT02327325|Secondary|Satisfaction With Physical Function Scale|This is a validated 5-item questionnaire that assesses patients' satisfaction with their ability to complete basic functional tasks that are often affected by lower extremity OA, including stair-climbing, walking, doing housework (light and heavy, and lifting and carrying. All items are rated on a 7-point scale ranging from Very Dissatisfied (-3) Very Satisfied (+3). A positive change score indicates improvement, and a negative change score indicates worsening.|Change from baseline to 12-week follow-up|"6 participants are missing data from this questionnaire because they entered a response of don't know for one or more items, and there were not adequate instructions for scoring the questionnaire with the missing data."|||units on a scale||95% Confidence Interval|Mean
2586810|NCT02327325|Secondary|Roland-Morris Disease Specific Disability Questionnaire|24-item self-report measure of low back pain-specific disability. Higher scores indicate worse function, with a range of 0=no disability to 24=maximum disability measured by the scale. Therefore a positive change score indicates worsening. A negative change score (e.g., lower score at follow-up) indicates improvement.|Change from baseline to 12-week follow-up||||units on a scale||95% Confidence Interval|Mean
2586811|NCT02327325|Secondary|Patient Specific Functional Scale|This measure captures items that are specific functional tasks that may be missed on standardized questionnaires. The measure consists of 3 items specifically provided by the patient. Each item provided by the patient is score from a 0 (Unable to perform task) to 10 (able to complete the activity without difficulty) scale. Higher change scores from baseline to follow up indicate more improvement (total range 0-30).|Change from baseline to 12-week follow-up||||units on a scale||95% Confidence Interval|Mean
2586812|NCT02327325|Primary|PROMIS Health Assessment Questionnaire|Self-reported physical function/disability measure that captures both activities of daily living and instrumental activities of daily living. It consists of 20-items scored on a 0-3 scale with a summed 0-100-unit scale. Higher scores are associated with worse function. Therefore a positive change score indicates worsening over time; negative change score (e.g., lower score at follow-up) indicates improvement.|Change from baseline to 12-week follow-up|"18 participants are missing data from this questionnaire because they entered a response of don't know for one or more items, and there were not adequate instructions for scoring the questionnaire with the missing data."|||units on a scale||95% Confidence Interval|Mean
2586813|NCT02327325|Primary|Timed Get-Up-And Go|This test requires the participants to stand from a standard arm chair, walk 3 meters and then return to sitting in the same chair. Greater number of seconds is associated with poorer physical function. Therefore, a positive change from baseline to follow-up means worsening function; a negative change (e.g., lower score at follow-up than at baseline) indicated improving function.|Change from baseline to 12-week follow-up|The analysis populations includes all participants except for one who was unable to stand without assistance and declined to perform this test at both baseline and follow-up.|||seconds||95% Confidence Interval|Mean
2586814|NCT02327260|Primary|Number of Participants With Self-reported Medication Adherence: Angiotensin System Blocker|"Participants were asked how many times they filled Angiotensin System Blockers since their discharge from TMC. Participants were coded as adherent if they reported an increased number of medication fills at 5 weeks compared to 1 week post-discharge. Participants with evidence of obtaining a medication fill greater than 30 days were also classified as adherent. Participants who did not indicate an increase in number of fills or provide evidence of extended coverage from initial fill were determined to be non-adherent. Dichotomized adherence categorization was utilized in data analyses: 1 = adherent; 0 = non-adherent. Data presented are % adherent."|Interview data at 5 weeks post-discharge||||Participants|||Count of Participants
2586815|NCT02327260|Primary|Number of Participants With Self-reported Medication Adherence: Statin|"Participants were asked how many times they filled Statins since their discharge from TMC. Participants were coded as adherent if they reported an increased number of medication fills at 5 weeks compared to 1 week post-discharge. Participants with evidence of obtaining a medication fill greater than 30 days were also classified as adherent. Participants who did not indicate an increase in number of fills or provide evidence of extended coverage from initial fill were determined to be non-adherent. Dichotomized adherence categorization was utilized in data analyses: 1 = adherent; 0 = non-adherent. Data presented are % adherent."|Interview data at 5 weeks post-discharge||||Participants|||Count of Participants
2586816|NCT02327260|Primary|Number of Participants With Self-reported Medication Adherence: Beta-Blocker|"Participants were asked how many times they filled Beta-Blockers since their discharge from TMC. Participants were coded as adherent if they reported an increased number of medication fills at 5 weeks compared to 1 week post-discharge. Participants with evidence of obtaining a medication fill greater than 30 days were also classified as adherent. Participants who did not indicate an increase in number of fills or provide evidence of extended coverage from initial fill were determined to be non-adherent. Dichotomized adherence categorization was utilized in data analyses: 1 = adherent; 0 = non-adherent. Data presented are % adherent."|Interview data at 5 weeks post-discharge||||Participants|||Count of Participants
2586817|NCT02327260|Primary|Number of Participants With Self-reported Medication Adherence: P2Y12 Platelet Inhibitor|"Participants were asked how many times they filled P2Y12 Platelet Inhibitors since their discharge from TMC. Participants were coded as adherent if they reported an increased number of medication fills at 5 weeks compared to 1 week post-discharge. Participants with evidence of obtaining a medication fill greater than 30 days were also classified as adherent. Participants who did not indicate an increase in number of fills or provide evidence of extended coverage from initial fill were determined to be non-adherent. Dichotomized adherence categorization was utilized in data analyses: 1 = adherent; 0 = non-adherent. Data presented are % adherent."|Interview data at 5 weeks post-discharge||||Participants|||Count of Participants
2586818|NCT02327260|Primary|Adherence (Ratio): Angiotensin System Blocker|A continuous single-interval medication availability ratio was calculated by dividing the number of days supplied by a pharmacy fill by the number of days before the next pharmacy fill for the same medication. A higher ratio was indicative of greater adherence.|Collected at 5 weeks post-discharge|We are missing some data because pharmacies did not respond to our requests.|||adherence ratio||Standard Deviation|Mean
2586839|NCT02327169|Secondary|Cmax : Maximum Observed Plasma Concentration for MLN2480||Cycle 1, Day 10 pre-dose and at multiple timepoints (Up to 48 hours) post-dose|The limited PK data did not allow to estimate the PK parameters defined in the protocol.||||||
2586821|NCT02327260|Primary|Adherence (Ratio): P2Y12 Platelet Inhibitor|A continuous single-interval medication availability ratio was calculated by dividing the number of days supplied by a pharmacy fill by the number of days before the next pharmacy fill for the same medication. A higher ratio was indicative of greater adherence.|Collected at 5 weeks post-discharge|Some pharmacies did not respond to us after repeated requests for participants' data; therefore, data are missing.|||adherence ratio||Standard Deviation|Mean
2586822|NCT02327260|Primary|Participation in CR|Whether participants attend an orientation session at TMC's CR program|Within 2 months of study enrollment||||Participants|||Count of Participants
2586823|NCT02327169|Secondary|Progression Free Survival (PFS)|PFS is defined as the time in months from the date of first study drug administration to the date of first documented PD or death due to any cause. PD was based on response evaluation criteria in solid tumors (RECIST V1.1), defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline then every 2 cycles beginning at Cycle 2, Day 27, until disease progression, death or end of study (Approximately up to 13 months)|Safety population is defined as all participants who received any amount of MLN2480. For a participant that has not progressed and has not died, PFS was censored at the last response assessment that is SD or better. Participants with no response assessment were censored at the date of first dose.|||months||95% Confidence Interval|Median
2586824|NCT02327169|Secondary|Time to Response|Time to response was defined as the time in months from the date of first dose of study treatment to the date of the first documentation of a PR or better response.|From date of enrollment to the date of the first documentation of a confirmed response (Up to 13 months)|Response-evaluable population was defined as all participants with measurable disease at baseline who received any amount of MLN2480 and have at least 1 post baseline response assessment.|||months||95% Confidence Interval|Median
2586825|NCT02327169|Secondary|Duration of Response|Duration of Response (DOR) was defined as the time in months from the first documented CR or PR per RECIST v. 1.1 to disease recurrence or disease progression (PD) whichever occurs first.|From first documented response until disease progression (Up to 13 months)|Responders from response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at baseline, and 1 postbaseline response assessment. For a participant that has not progressed, DOR was censored at the last response assessment.|||months||95% Confidence Interval|Median
2586826|NCT02327169|Secondary|Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST)|ORR was defined as the percentage of participants with complete response (CR) or partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.|Baseline then every 2 cycles beginning at Cycle 2, Day 27, until disease progression, death or end of study (Up to 13 months)|Response-evaluable population was defined as participants who received at least 1 dose of study drug, had measurable disease at baseline, and 1 postbaseline response assessment.|||percentage of participants||95% Confidence Interval|Number
2586827|NCT02327169|Secondary|Terminal Elimination Half-life (T1/2) for Paclitaxel||Cycle 1, Day 15 pre-dose and at multiple timepoints (Up to 48 hours) post-dose|The limited PK data did not allow to estimate the PK parameters defined in the protocol.||||||
2586828|NCT02327169|Secondary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for Paclitaxel||Cycle 1, Day 15 pre-dose and at multiple timepoints (Up to 48 hours) post-dose|The limited PK data did not allow to estimate the PK parameters defined in the protocol.||||||
2586829|NCT02327169|Secondary|AUC(0-last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Paclitaxel||Cycle 1, Day 15 pre-dose and at multiple timepoints (Up to 48 hours) post-dose|The limited PK data did not allow to estimate the PK parameters defined in the protocol.||||||
2586830|NCT02327169|Secondary|Cmax: Maximum Observed Plasma Concentration for Paclitaxel||Cycle 1, Day 15 pre-dose and at multiple timepoints (Up to 48 hours) post-dose|The limited PK data did not allow to estimate the PK parameters defined in the protocol.||||||
2586831|NCT02327169|Secondary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Alisertib||Cycle 1, Day 10 pre-dose and at multiple timepoints (Up to 48 hours) post-dose|The limited PK data did not allow to estimate the PK parameters defined in the protocol.||||||
2586832|NCT02327169|Secondary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for MLN0128||Cycle 1, Day 10 pre-dose and at multiple timepoints (Up to 48 hours) post-dose|The limited PK data did not allow to estimate the PK parameters defined in the protocol.||||||
2586833|NCT02327169|Secondary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for MLN2480||Cycle 1, Day 10 pre-dose and at multiple timepoints (Up to 48 hours) post-dose|The limited PK data did not allow to estimate the PK parameters defined in the protocol.||||||
2586834|NCT02327169|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib||Cycle 1, Day 10 pre-dose and at multiple timepoints (Up to 48 hours) post-dose|The limited PK data did not allow to estimate the PK parameters defined in the protocol.||||||
2586835|NCT02327169|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0128||Cycle 1, Day 10 pre-dose and at multiple timepoints (Up to 48 hours) post-dose|The limited PK data did not allow to estimate the PK parameters defined in the protocol.||||||
2586836|NCT02327169|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN2480||Cycle 1, Day 10 pre-dose and at multiple timepoints (Up to 48 hours) post-dose|The limited PK data did not allow to estimate the PK parameters defined in the protocol.||||||
2586837|NCT02327169|Secondary|Cmax: Maximum Observed Plasma Concentration for Alisertib||Cycle 1, Day 10 pre-dose and at multiple timepoints (Up to 48 hours) post-dose|The limited PK data did not allow to estimate the PK parameters defined in the protocol.||||||
2586838|NCT02327169|Secondary|Cmax: Maximum Observed Plasma Concentration for MLN0128||Cycle 1, Day 10 pre-dose and at multiple timepoints (Up to 48 hours) post-dose|The limited PK data did not allow to estimate the PK parameters defined in the protocol.||||||
2586842|NCT02327169|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|DLT was defined using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 and included: any drug-related hematologic toxicity ≥Grade 4 with the exception of Grade 4 neutropenia <7 days duration; Grade 3 or 4 neutropenia with fever >38.5 degrees Celsius and/or infection or neutropenia requiring colony-stimulating factor OR non-hematologic DLTs that were any Grade 3, 4, or 5 toxicity with the following exceptions: Grade 3 nausea, vomiting, diarrhea, and dehydration occurring in a setting of inadequate treatment; inadequately treated hypersensitivity reactions; Grade 3 elevated transaminases or urine electrolyte abnormality ≤1 week in duration; Grade 3 serum electrolyte abnormality ≤72 hours in duration. DLTs also included: drug-related adverse experience that lead to a dose modification; unresolved drug-related toxicity resulted in delay in initiation of Cycle 2.|From Day 1, Cycle 1 through 30 days after the last dose in Cycle 1 (up to 8 weeks)|The DLT-evaluable population was defined as all participants in the dose escalation phase of the study who either experienced DLT during cycle 1, or completed at least 75% of the scheduled doses in cycle 1 without DLT.|||Participants|||Count of Participants
2586843|NCT02327169|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An SAE means any untoward medical occurrence that at any dose results in death, is life-threatening, requires in patient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.|From Day 1, Cycle 1 through 30 days after the last dose of study drug (up to 13 months)|Safety population was defined as all participants who received any amount of MLN2480.|||Participants|||Count of Participants
2586844|NCT02327143|Secondary|PK: Time of Maximum Observed Drug Concentration (Tmax) of LY2835219||Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose|All participants who received at least 1 dose of study drug and had evaluable PK data|||hours||Full Range|Median
2586845|NCT02327143|Secondary|PK: Maximum Observed Concentration (Cmax) of LY2835219||Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose|All participants who received at least 1 dose of study drug and had evaluable PK data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2586846|NCT02327143|Primary|Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-∞)] of LY2835219 and ¹³C₈-LY2835219||Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose|All participants who received at least 1 dose of study drug and had evaluable PK data|||nanogram*h/milliliter (ng∙h/mL)||Geometric Coefficient of Variation|Geometric Mean
2586847|NCT02327130|Other Pre-specified|Positive and Negative Predictive Value of BDV for Infection Diagnosis|"Based on an ROC analysis the optimal cutoff value for indicating the presence of infection using the BDV is 1.4‰.~Based on this cutoff value the sensitivity and specificity were calculated. Sensitivity, or the true positive rate, is the proportion of actual positives that are correctly identified. In this case, the sensitivity is the percentage of people who have an infection and were identified by the Isomark Canary as having an 'infection'.~The specificity, or the true negative rate, is the promotion of actual negatives that are correctly identified as negative. In this case, the specificity is the proportion of people without infections that were correctly classified by the Isomark Canary as having 'no infection'."|7 days||||percent|||Number
2586848|NCT02327130|Secondary|Number of Participants With an Infection Diagnosis|Daily analysis infection status from blood samples given from each participant.|Days 1 through 7||||Participants|||Number
2586849|NCT02327130|Primary|Change in Breath Delta Value|"The variation in breath delta value was assessed regardless of infection status. Exhaled breath samples were collected from participants upon enrollment and every four hours thereafter until the end of the subject's study duration per protocol. Each subject was used as its own control for the purpose of trend analysis.The first breath sample collected was considered an individual's baseline sample. The change in the breath delta value was calculated from this baseline sample."|Baseline to ICU discharge or 7 days, whichever came first||||parts per mil (‰)||Standard Error|Mean
2586850|NCT02327117|Primary|Hb Level 48 Hours After Total Knee Arthroplasty||48 hours after TKA||||gr/dL||Standard Deviation|Mean
2586851|NCT02327013|Secondary|Change in AAQoL Subscales - Relationships Sub-score|The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Relationship subscale is based on 5 items and ranges from 5 to 25. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586852|NCT02327013|Secondary|Change in AAQoL Subscales - Life Outlook Sub-score|The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Life Outlook subscale is based on 7 items and ranges from 7 to 35. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586853|NCT02327013|Secondary|Change in AAQoL Subscales - Psychological Health Sub-score|The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Psychological Health subscale is based on 6 items and ranges from 6 to 30. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586854|NCT02327013|Secondary|Change in AAQoL Subscales - Life Productivity Sub-score|The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Life productivity subscale is based on 11 items and ranges from 11 to 55. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586855|NCT02327013|Secondary|Change in Adult ADHD Quality of Life Measure (AAQoL) Total Score|The AAQoL is a patient-rated scale designed to assess health-related quality of life in adults with ADHD. The AAQoL consists of 29 items, each item is rated on a 5-point scale from 1 (not at all/never) to 5 (extremely/very often). The AAQoL Total score is based on all 29 items and ranges from 29 to 145. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586856|NCT02327013|Secondary|Change in WLQ Domain Scores - Output Demands|Output Demands is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586857|NCT02327013|Secondary|Change in WLQ Domain Scores - Physical Demands|Physical Demands is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586858|NCT02327013|Secondary|Change in WLQ Domain Scores - Mental-Interpersonal Work Demands|Mental-Interpersonal Work Demands is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586859|NCT02327013|Secondary|Change in WLQ Domain Scores - Limitations Handling Time|Limitations Handling Time is scored on a scale of 0 (limited at work none of the time) to 100 (limited at work all of the time) based on a converted mean score. A reduction in score indicates less work limitation.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586860|NCT02327013|Secondary|Change in WLQ Using the Global Productivity Index|"The WLQ is a patient self-rated scale designed to assess on-the-job impact of chronic health problems and/or treatment. The WLQ consists of 25 items in 4 dimensions: limitations handling time (5 items), physical work demands (6 items), mental-interpersonal work demands (9 items), and output demands (5 items). Each item is rated on a 5-point scale from All of the Time (score 5) to None of the Time (score 0), or Does Not Apply to My Job. The Global Productivity Index is calculated as a weighed sum of the 4 dimensions, and ranges from 0.000 to 0.286. Reduction in score indicates less work limitation."|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||Index||Standard Error|Least Squares Mean
2586861|NCT02327013|Secondary|Change in SDS Item Scores - Number of Underproductive Days|This SDS item captures the number of underproductive days (see outcome 4)|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||days||Standard Error|Least Squares Mean
2586862|NCT02327013|Secondary|Change in SDS Item Scores - Number of Days Lost|This SDS item captures days lost from school or work (see outcome 4).|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||days||Standard Error|Least Squares Mean
2586863|NCT02327013|Secondary|Change in SDS Item Scores - Social Life|The SDS item social life is rated from 0 = normal functioning to 10 = severe functional impairment (see outcome 4). A higher score represents more severe functional impairment. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586864|NCT02327013|Secondary|Change in SDS Item Scores - Work|The SDS item work is rated from 0 = normal functioning to 10 = severe functional impairment (see outcome 4). A higher score represents more severe functional impairment. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586865|NCT02327013|Secondary|Change in SDS Item Scores - Family|The SDS item family is rated from 0 = normal functioning to 10 = severe functional impairment (see outcome 4). A higher score represents more severe functional impairment. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586866|NCT02327013|Secondary|Change in PDQ-D Sub-scales - Planning and Organisation Sub-score|The PDQ-D planning and organisation sub-score consists of items 4, 8, 12, 16, and 20 of the PDQ (see Outcome 23) with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586867|NCT02327013|Secondary|Change in PDQ-D Sub-scales - Prospective Memory Sub-score|The PDQ-D prospective memory sub-score consists of items 3, 7, 11, 15, and 19 of the PDQ (see Outcome 23) with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586868|NCT02327013|Secondary|Change in PDQ-D Sub-scales - Retrospective Memory Sub-score|The PDQ-D retrospective memory sub-score consists of items 2, 6, 10, 14, and 18 of the PDQ (see Outcome 23) with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586869|NCT02327013|Secondary|Change in PDQ-D Subscales - Attention and Concentration Sub-score|The PDQ-D attention/concentration sub-score consists of items 1, 5, 9, 13, and 17 of the PDQ with a score ranging from 0 to 20. A higher score reflects greater subjective cognitive impairment. A reduction in score indicates less cognitive impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586870|NCT02327013|Secondary|Change in Perceived Deficits Questionnaire - Depression (PDQ-D) Total Score|The PDQ-D is a patient-rated scale designed to assess cognitive impairment/dysfunction adapted for MDD. Each item is rated on a scale from 0 (never) to 4 (almost always). The total score of the 20 items ranges from 0 to 80 with higher scores reflect greater subjective cognitive impairment. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586871|NCT02327013|Secondary|Change in BRIEF-A Subscales - Emotional Control|The BRIEF-A subscale Emotional Control is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
2586872|NCT02327013|Secondary|Change in BRIEF-A Subscales - Working Memory|The BRIEF-A subscale Working Memory is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
2586873|NCT02327013|Secondary|Change in BRIEF-A Subscales - Task Monitor|The BRIEF-A subscale Task Monitor is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
2586874|NCT02327013|Secondary|Change in BRIEF-A Subscales - Self Monitor|The BRIEF-A subscale Self Monitor is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
2586894|NCT02326844|Other Pre-specified|Forkhead Box 03 (FOXO3a), p53-binding Protein 1 (53BP1) and RAD51 (i.e., Eukaryote Gene) Biomarkers|Patients will undergo a mandatory biopsy at baseline and reverse phase protein microarray (RPPA)26 testing will be performed to determine the potential predictive biomarkers of subsequent poly (adenosine diphosphate [ADP]) ribose polymerase inhibitors (PARPi ) response.|Baseline||2020-03-31|03/2020||||
2586875|NCT02327013|Secondary|Change in BRIEF-A Subscales - Shift|The BRIEF-A subscale Shift is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
2586876|NCT02327013|Secondary|Change in BRIEF-A Subscales - Planning/Organize|The BRIEF-A subscale Planning/Organize is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
2586877|NCT02327013|Secondary|Change in BRIEF-A Subscales - Organization of Materials|The BRIEF-A subscale Organization of Materials is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
2586878|NCT02327013|Secondary|Change BRIEF-A Subscales - Initiate|The BRIEF-A subscale Initiate is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
2586879|NCT02327013|Secondary|Change in BRIEF-A Subscales - Inhibit|The BRIEF-A subscale Inhibit is a subscale within the Behavioural Regulation Index (BRI). Each item is rated on a 3-point scale ranging from 1 (never) to 3 (often). Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
2586880|NCT02327013|Secondary|Change in BRIEF-A Using the Behavioural Regulation Index|The Behavioral Regulation Index (BRI) is an index score of the BRIEF-A and consists of 4 scales: inhibit, shift, emotional control, and self-monitor). Each item is rated on a 3-point scale with the numeric score of 1 to 3. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
2586881|NCT02327013|Secondary|Response (Defined as a CGI-I Score of 1 or 2), Stage 1|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Higher scores indicate worsening.|Week 6|CGI-I refers to study baseline and was for this reason analyzed for Stage 1 only.|||percentages of participants|||Number
2586882|NCT02327013|Secondary|Clinical Global Impression - Global Improvement (CGI-I) Score|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Higher scores indicate worsening.|Week 6|CGI-I refers to study baseline and was for this reason analyzed for Stage 1 only.|||units on a scale||Standard Error|Least Squares Mean
2586883|NCT02327013|Secondary|Change in Clinical Global Impression - Severity of Illness (CGI-S) Score|The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate worsening.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586884|NCT02327013|Secondary|Change in Adult ADHD Self-Report Scale (ASRS) Total Score|"The Adult ADHD Self-Report Scale (ASRS) is a patient-rated scale designed to assess the ADHD symptoms in adults based on the diagnostic criteria of DSM-IVTM. The ASRS consist of 18 items, each rated on a 5-point scale from Never to Very Often. The categories Never and Rarely were combined when calculating the total score to mirror the scoring of the AISRS, with 0 representing Never/Rarely and 3 representing Very Often. The Total Score ranges from 0 to 54. A reduction in score indicates less severity of ADHD."|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586936|NCT02325791|Secondary|Part B: Serum Concentration of Suptavumab|Serum samples for drug concentration will be collected at pre-specified time points|Day 29, 57, 85, 113 and Day 150 Post-dose|"The PK analysis set included participants who received a single dose of suptavumab and had at least 1 measurable concentration of suptavumab in serum. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specific time point."|||Milligram per liter (mg/L)||Standard Deviation|Mean
2586885|NCT02327013|Secondary|Percentage of Patients Responding (Response Defined as 30% or Greater Reduction From Baseline in AISRS Total Score)|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined response rate was obtained by constructing an equally weighed estimate of the rate combining the two stages.|||percentage of participants|||Number
2586886|NCT02327013|Secondary|Change AISRS Hyperactivity/Impulsivity Sub-score|The AISRS hyperactive/impulsive subscale score consists of 9 items from the AISRS which address hyperactivity and impulsivity. Each item is rated from 0 to 3. The AISRS hyperactive/impulsive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD hyperactivity/impulsivity.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586887|NCT02327013|Secondary|Change in AISRS Inattention Sub-score|The AISRS inattentive subscale score consists of 9 items from the AISRS which address inattention. Each item is rated from 0 to 3. The AISRS inattentive subscale score can range from 0 to 27. A higher score corresponds to a worse severity of ADHD inattentiveness.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586888|NCT02327013|Secondary|Productivity: Change in Work Limitations Questionnaire (WLQ) Productivity Loss Score|"The WLQ is a patient self-rated scale designed to assess on-the-job impact of chronic health problems and/or treatment. The WLQ consists of 25 items in 4 dimensions: limitations handling time (5 items), physical work demands (6 items), mental-interpersonal work demands (9 items), and output demands (5 items). Each item is rated on a 5-point scale from All of the Time (score 5) to None of the Time (score 0), or Does Not Apply to My Job. The WLQ Productivity Loss Score is derived from the Global Productivity Index, which is calculated as a weighed sum of the 4 dimensions. Reduction in WLQ Productivity Loss score indicates less work limitation and represents the estimated percentage of productivity loss in the past two weeks due to presenteeism relative to a healthy benchmark sample. WLQ Productivity Loss Score ranges from 0% to 24,9%."|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||percentage of days lost||Standard Error|Least Squares Mean
2586889|NCT02327013|Secondary|Overall Functioning: Change in Sheehan Disability Scale (SDS) Total Score|The SDS comprises a series of patient rated scales designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and 3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment. The number of days lost and the number of underproductive days last from work/school due to symptoms are also captured. The total score is calculated as a sum of the 3 visual analogue scales, ranges from 0 to 30. A higher score represents more severe functional impairment. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586890|NCT02327013|Secondary|Cognitive Function/Global Executive Function: Change in BRIEF-A Using the Global Executive Composite Score|BRIEF-A is a validated questionnaire composed of 75-item within nine non-overlapping scales: 4 scales in the Behavioral Regulation Index (BRI) (inhibit, shift, emotional control, and self-monitor), and 5 scales in the Metacognition Index (MI) (initiate, working memory, plan/organise, task monitor, and organization of materials). Each item is rated on a 3-point scale with the numeric score of 1 to 3. The BRIEF-A yields an overall score (Global Executive Composite) composed of two index scores, the MI and the BRI. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
2586891|NCT02327013|Secondary|Inattention/Meta-cognition: Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Using Metacognition Index|The Metacognition Index (MI) is an index score of the BRIEF-A consisting of 5 scales: initiate, working memory, plan/organise, task monitor, and organization of materials. Each item is rated on a 3-point scale with the numeric score of 1 to 3. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||T-score||Standard Error|Least Squares Mean
2586892|NCT02327013|Primary|Change in ADHD Investigator Symptom Rating Scale (AISRS) Total Score|AISRS: an 18-item scale administered by the investigator. It included 9 items that evaluated symptoms of inattention and 9 items that evaluated symptoms of impulsivity and hyperactivity. Each item was rated from 0 (none) to 3 (severe). AISRS total score was calculated as sum of all the items on the scale and ranged from 0 to 54. A higher score corresponded to a worse severity of ADHD.|Baseline to Week 6|Stage 2 dataset includes placebo non-responders from Stage 1 that were re-randomized and treated in Stage 2. The statistical analyses were performed on each stage separately, and the combined analysis was performed by constructing a simple equally weighed least square test-statistic.|||units on a scale||Standard Error|Least Squares Mean
2586895|NCT02326844|Secondary|Progression Free Survival (PFS) on BMN673 (Talazoparib) to PFS From First Poly (ADP-ribose) Polymerase Inhibitor (PARPPi) Exposure|The median time to progression after receiving BMN673 will be compared informally to the time of progression for the same patients after receiving an initial PARPi exposure. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more lesions is also considered progressions).|3 months|This outcome measure was not done because the study was prematurely closed by the Cancer Therapy Evaluation Program (CTEP) sponsor following the enrollment of 3 subjects. We were unable to analyze biomarker endpoints due to insufficient number of samples after premature closure of the study.||||||
2586896|NCT02326844|Secondary|Duration of Response|Duration of response is the time between study enrollment and off-treatment date.|3 months||||months||Full Range|Median
2586897|NCT02326844|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events v4.0. For a detailed list of events, see the adverse event module.|15 months||||Participants|||Count of Participants
2586898|NCT02326844|Primary|Objective Response (Complete Response (CR) + Partial Response (PR))|Objective response (complete response (CR) + partial response (PR)) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|Every 2 cycles, an average of 64 days||||Participants|||Count of Participants
2586899|NCT02326649|Primary|Mean Difference in Stroke Volume Between CMR and SMIC|Mean difference in stroke volume (SV) between CMR and SMIC measurements in ml|2 hours||||ml||95% Confidence Interval|Mean
2586900|NCT02326597|Secondary|Mean Decisional Regret Scale Score|Decision Regret Scale measures distress or remorse after a health care decision. The subject rates regret using a 5 point Likert scale in answering the following questions; 1. It was the right decision 2. I regret the decision 3. I would go for the same decision if I were to do it again 4. The decision caused me a lot of harm 5. It was a wise decision. Total scores range from 0 to 100. A score of 0 means no regret; a score of 100 means high regret.|Visit 3|Number of participants who completed the scale.|||units on a scale||Standard Deviation|Mean
2586901|NCT02326597|Secondary|Mean Knowledge Survey Scores|Knowledge Survey is a 25 multiple choice questionnaire which assesses how much knowledge is being retained after information about risks is received. The knowledge survey is scored as percent correct answers at each time point. This is a set of questions to test knowledge and understanding about sickle cell disease and treatments. As such the answers are dichotomous i.e true or false. The total score of percent correct answers is scored in the range of 0-100%.|Baseline, Month 3, Month 6|The analysis includes all participants who completed the survey.|||units on a scale||Standard Deviation|Mean
2586902|NCT02326597|Secondary|Mean Change in Preparation for Decision Making Scale Score|Preparation for Decision Making Scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation focused on making a health decision. The preparation for decision-making scale is scored on a 0-100 scale. Higher scores indicate a higher perceived level of preparation for decision making. The total score on the decision making scale is a continuous outcome.|Month 3, Month 6|The analysis includes all participants who completed the survey.|||units on a scale||Standard Deviation|Mean
2586903|NCT02326597|Secondary|Mean Values Survey Score|"The values survey consists of 14 multiple choice questions to measure what is important to a patient when making decisions. The patient decision aid will be tested in the twelve domains of the international patient decision aid standards collaboration criteria checklist. Respondents will be asked to identify perceived importance of individual items (such as procedure related complications, decreasing complication risks, experiencing less pain) and to rate this importance on a 10 point likert scale (0-10) where 1 indicates not important to me at all and 10 indicates extremely important to me. Scores are then converted it to an 11 point scale and averaged."|Post Visit 1 (Up to 2 Weeks)|The analysis includes all participants who completed the survey.|||units on a scale||Standard Deviation|Mean
2586904|NCT02326597|Secondary|Mean Difference in Decisional Conflict Scale Scores|Decisional Conflict scale responses are scored for the total score, uncertainty sub-score, informed sub-score, values clarity sub-score, support sub-score and effective decision sub-score. The total score ranges from 0 (no decisional conflict) to 100 (extremely high decisional conflict). The uncertainty sub-score ranges from 0 (feels extremely certain about best choice) to 100 (feels extremely uncertain about best choice). The informed sub-score ranges from 0 (feels extremely informed) to 100 (feels extremely uninformed). The values clarity sub-score ranges from 0 (feels extremely clear about personal values for benefits & risks) to 100 (feels extremely unclear about personal values). The support sub-score ranges from 0 (feels extremely supported in decision making) to 100 (feels extremely unsupported in decision making). The effective decision sub-score ranges from 0 (good decision) to 100 (bad decision).|Baseline, Month 6|Analysis was completed for participants who completed the scale at both baseline and month 6 visits.|||units on a scale||95% Confidence Interval|Mean
2586905|NCT02326597|Secondary|Mean Difference in Decisional Conflict Scale Scores|Decisional Conflict scale responses are scored for the total score, uncertainty sub-score, informed sub-score, values clarity sub-score, support sub-score and effective decision sub-score. The total score ranges from 0 (no decisional conflict) to 100 (extremely high decisional conflict). The uncertainty sub-score ranges from 0 (feels extremely certain about best choice) to 100 (feels extremely uncertain about best choice). The informed sub-score ranges from 0 (feels extremely informed) to 100 (feels extremely uninformed). The values clarity sub-score ranges from 0 (feels extremely clear about personal values for benefits & risks) to 100 (feels extremely unclear about personal values). The support sub-score ranges from 0 (feels extremely supported in decision making) to 100 (feels extremely unsupported in decision making). The effective decision sub-score ranges from 0 (good decision) to 100 (bad decision).|Baseline, Month 3|Analysis was completed for participants who completed the scale at both baseline and month 3 visits.|||units on a scale||95% Confidence Interval|Mean
2586906|NCT02326597|Secondary|Mean Decisional Self-Efficacy Scale Score|The Decision Self-Efficacy Scale measures self-confidence or belief in one's ability to make decisions, including participate in shared decision making. Items are scored on a scale of 0-4 where 0 is not at all confident and 4 represents very confident.Total scores range from 0 (not at all confident) to 100 (very confident). A score of 0 means 'extremely low self- efficacy' and a score of 100 means 'extremely high self-efficacy.|Month 3, Month 6|Analysis was completed for participants who completed the scale at month 3 and month 6 visits.|||units on a scale||Standard Deviation|Mean
2586907|NCT02326597|Primary|Acceptability of Decision Aid Education Assessed by the Acceptability Survey|Subjects will take an acceptability of education questionnaire which is a 8-item survey to assess the comprehension of education received for the decision aid tool. Each item will be scored on a scale from 1-4 where 1=poor, 2=fair, 3=good, and 4=excellent. Scores will be rated individually 1-4 according to each item. There is no overall total score.|Post Visit 1 (Up to 2 Weeks)|Analysis was completed in both the standard practice and standard practice + decision aid groups together. There were a total of 106 participants who completed the survey.|||units on a scale||Standard Deviation|Median
2586908|NCT02326298|Secondary|Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48|The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.|At Week 48|The Randomized Set included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants||95% Confidence Interval|Number
2586909|NCT02326298|Secondary|Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 48|The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0= clear, 1= almost clear, 2= mild, 3= moderate, 4= severe.|At Week 48|The Randomized Set included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants||95% Confidence Interval|Number
2586910|NCT02326298|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16|The DLQI is a subject-reported questionnaire designed for use in adult participants with PSO. The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL). This instrument asks participants about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 30 with higher scores indicating lower HRQoL. A higher than of equal to (>=) 4-point change in the DLQI score (DLQI response) has been reported to be meaningful for the patient (within-patient minimal important difference Basra et al, 2015) a DLQI absolute score of lower than or equal to (=<) 1 indicates DLQI remission (i.e., no or small impact of the disease on HRQoL).|At Week 16|The Randomized Set included all participants randomized into the study. Missing data were handled using the last observation carried forward (LOCF) method for the DLQI.|||Scores on a scale||Standard Error|Least Squares Mean
2586911|NCT02326298|Secondary|Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16|The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.|At Week 16|The Randomized Set included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants|||Number
2586912|NCT02326298|Primary|Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16|The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.|At Week 16|The Randomized Set included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants|||Number
2586913|NCT02326298|Primary|Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16|The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.|At Week 16|The Randomized Set included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants|||Number
2586914|NCT02326272|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16|The DLQI is a subject-reported questionnaire designed for use in adult subjects with PSO. The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect patients' health related quality of life (HRQoL). This instrument asks subjects about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has been shown to be valid and reproducible in PSO patients. The DLQI score ranges from 0 to 30 with higher scores indicating lower HRQoL. A higher than or equal to (>=) 4-point change in the DLQI score (DLQI response) has been reported to be meaningful for the patient (within-patient minimal important difference Basra et al, 2015) a DLQI absolute score of lower than or equal to (=<) 1 indicates DLQI remission (i.e., no or small impact of the disease on HRQoL).|Week 16|The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||Scores on a scale||Standard Error|Least Squares Mean
2586915|NCT02326272|Secondary|Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 48|The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.|Week 48|The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants||95% Confidence Interval|Number
2586916|NCT02326272|Secondary|Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 48|The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.|Week 48|The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants||95% Confidence Interval|Number
2586917|NCT02326272|Secondary|Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI90) Response at Week 16|The PASI90 response assessments are based on at least 90% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.|Week 16|The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants|||Number
2586918|NCT02326272|Primary|Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16|The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.|Week 16|The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants|||Number
2586919|NCT02326272|Primary|Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16|The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.|Week 16|The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.|||percentage of participants|||Number
2586920|NCT02326233|Secondary|Time to Reach Cmax (Tmax)||0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose||||h||Full Range|Median
2586921|NCT02326233|Primary|Maximum Serum Concentration (Cmax)||0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose||||μg/mL||Standard Deviation|Mean
2586922|NCT02326233|Primary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)||0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose||||h·μg/mL||Standard Deviation|Mean
2586923|NCT02326233|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)||0, 24, 48, 96, 120, 144, 168, 216, 264, 336, 408, 504, 600, 696, 840, 1008, and 1344 h postdose||||h·μg/mL||Standard Deviation|Mean
2586955|NCT02325687|Secondary|Length of Stay in the Recovery Unit|Levels of blood oxygen saturation throughout the length of stay in the recovery unit will be measured via arterial blood gas levels, found in the patient's electronic medical record|Throughout stay in the recovery unit, or an average of 1-2 days.|||||||
2586924|NCT02326025|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|"The percentage of participants with a best overall response achieving CR or PR (ORR) was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions. The methodology for the confidence interval calculation is the exact F method."|Baseline to Measured Progressive Disease, Study Discontinuation or Death (Up to 24 Months)|All participants who received at least one dose of study drug and had a post-baseline lesion response.|||percentage of participants||95% Confidence Interval|Number
2586925|NCT02326025|Secondary|Percentage of Participants With Olaratumab Antibodies|The formation of anti-drug antibodies (ADA) was assessed using validated ELISAs, following a 4-tier approach. Both the ADA screening assay and the neutralizing antibody assay were validated in accordance with the US Food and Drug Administration (FDA) Guidance for Industry. Participants who had positive samples for treatment emergence due to being <4-fold difference from baseline or occurred prior to drug exposure are reported.|Preinfusion on Day 1 of Cycles 1 through 3 and Preinfusion on Day 1 of Every Second Cycle Thereafter, Up to 30-Day Follow Up|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline anti-olaratumab antibodies.|||percentage of participants|||Number
2586926|NCT02326025|Secondary|PK: Tmax Olaratumab|Tmax times are relative to the start of the approximately 60-minute IV infusion of olaratumab. PK data includes Part A Olaratumab alone and Part B Olaratumab + Doxorubicin.|C1 D10: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose; C2 D1: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose|All participants who received at least one dose of study drugs and had evaluable PK data.|||h||Full Range|Median
2586927|NCT02326025|Secondary|PK: Cmax Olaratumab|PK data includes Part A Olaratumab alone and Part B Olaratumab + Doxorubicin.|C1 D10:Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose; C2 D1: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose|All participants who received at least one dose of study drugs and had evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2586928|NCT02326025|Secondary|PK: AUC Zero to Time t, Where t is the Last Time Point (0-tLast) Olaratumab|PK: AUC (0-tLast) with a measurable concentration. PK data includes Part A Olaratumab alone and Part B Olaratumab + Doxorubicin.|C1 D10: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose; C2 D1: Predose, 0, 1, 4, 24, 48, 72, 96 Hrs Post dose|All participants who received at least one dose of study drugs and had evaluable PK data.|||ng∙h/mL||Geometric Coefficient of Variation|Geometric Mean
2586929|NCT02326025|Secondary|PK:Time of Maximum Observed Concentration (Tmax) Doxorubicin||C1 and C2, D1: Predose, 0.5, 1, 2, 4, 8, 24, 48, 72, 96 Hrs Post dose|All participants who received at least one dose of study drugs and had evaluable PK data.|||hour (h)||Full Range|Median
2586930|NCT02326025|Primary|PK: Maximum Concentration (Cmax) Doxorubicin||C1 and C2, D1: Predose, 0.5, 1, 2, 4, 8, 24, 48, 72, 96 Hrs Post dose|All participants who received at least one dose of study drugs and had evaluable PK data.|||nanogram/milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
2586931|NCT02326025|Primary|Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞]) Doxorubicin||Cycle(C)1 and (C)2, Day(D)1: Predose, 0.5, 1, 2, 4, 8, 24, 48, 72, 96 Hours (Hrs) Post dose|All participants who received at least one dose of study drugs and had evaluable PK data.|||nanogram*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2586932|NCT02325856|Secondary|Complications During DW Adjustment|we wanted to compared whether the dialysis-related complications are different when DW (dry weight) is adjusted, no matter according to BCM (body composition monitor) results or clinical judgement, in both groups. The result is expressed as the percentage of months in which complications happened when DW adjustment presented (using total months which DW adjustments are present as denominator).|1 year||||% of months in which compli|Participants||Number
2586933|NCT02325856|Primary|All-cause Hospitalization||1 year||||hospitalizations per patient-year||95% Confidence Interval|Number
2586934|NCT02325791|Secondary|Part B: Percentage of Participants Hospitalized With Medically Attended RSV Infection or Outpatient Visit Lower Respiratory Tract Infection (LRTI) or Upper Respiratory Tract Infection (URTI) Up to Day 150|A medically attended RSV infection was defined as an infant with a positive RSV test by RT-PCR with any of the following events: -Hospitalized (on the basis of the assessment of the admitting physician) for RSV infection - or Outpatient visit (ER, UC), or pediatric clinic visits [for either a sick or well visit]) with RSV LRTI. An RSV LRTI in an infant: RSV-proven respiratory infection (i.e, positive RSV RT-PCR test) with parent(s)/guardian(s) report of cough or difficulty breathing, and with 1 of the following signs of LRTI, as assessed by a healthcare provider: -Lower chest wall indrawing -Hypoxemia (peripheral capillary oxygen saturation <95% breathing room air) -Wheezing or crackles. The 150-day efficacy assessment period:first study drug intake through the Day 150 visit.|From the first study drug administration up to Day 150|Analysis was performed on FAS population.|||Percentage of participants|||Number
2586935|NCT02325791|Secondary|Part B: Number of Participants With At Least One Positive Anti-Drug Antibody (ADA) Assay|ADA category of each participant was classified as pre-existing immunoreactivity (a positive ADA response at baseline with a <4-fold increase in titer for all post baseline samples), treatment-boosted (a positive response at baseline with at least one post baseline titer at >=4-fold the baseline titer), or treatment-emergent (TE [any positive post baseline assay response when baseline results were negative or missing]). TE ADA responses were further classified as persistent (treatment-emergent positive ADA response detected in at least 2 consecutive post baseline samples separated by at least a 12-week post baseline period [based on nominal sampling time], with no ADA-negative samples in-between, regardless of any missing samples or a positive response at the last ADA sampling time point), indeterminate (a positive assay response at the last collection time point only, regardless of any missing samples), or transient (not persistent/indeterminate, regardless of any missing samples).|Day 1 through Day 150|The ADA analysis set contained participants who received a single dose of suptavumab and had at least 1 post-treatment ADA result.|||Participants|||Count of Participants
2586956|NCT02325687|Secondary|Levels of Blood Oxygen Saturation|Levels of blood oxygen saturation will be measured via arterial blood gas levels. These will be drawn as standard-of-care.|Throughout stay in the recovery unit, or an average of 1-2 days.|||||||
2586937|NCT02325791|Secondary|Part A: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|Any untoward medical occurrence in participants, who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs: AEs that developed/worsened/became serious during on-treatment period (defined as time between the date of first study drug administration & date of end of study/last visit).Serious AE: Any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious & non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) version 4.03(Grade 3 [severe] & Grade 4[life-threatening]) was used in this study to grade clinical AEs.|Baseline through Day 150|Safety analysis set (SAF) included participants who received any dose of suptavumab.|||Percentage of participants|||Number
2586938|NCT02325791|Primary|Part B: Percentage of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Infection (Hospitalization or Outpatient Visit With Lower Respiratory Tract Infection [LRTI]) Up to Day 150|A medically attended RSV infection defined as an infant with positive RSV test by Reverse-transcriptase polymerase chain reaction (RT-PCR) with any of following events: Hospitalized (on basis of assessment of admitting physician) for RSV infection or outpatient visit (emergency room [ER], urgent care [UC], or pediatric clinic visits [for either a sick or well visit]) with RSV lower respiratory tract infection (LRTI). An RSV LRTI in an infant: RSV proven respiratory infection (i.e positive RSV RT-PCR test) with parent(s)/guardian(s) report of cough/difficulty breathing, & with 1 of following signs of LRTI, as assessed by healthcare provider: - lower chest wall in drawing -hypoxemia (peripheral capillary oxygen saturation <95% breathing room air) - Wheezing/crackles. The 150-day efficacy assessment period: first study drug intake through the Day 150 visit.|From first study drug administration up to Day 150|Full analysis set (FAS) included all randomized participants who received any study drug and was analyzed according to treatment allocated by Interactive voice response system (IVRS)/ Interactive web response system (IWRS) at randomization (as randomized).|||Percentage of participants|||Number
2586939|NCT02325791|Primary|Part A: Serum Concentration of Suptavumab Over Time|Part A was primarily designed to determine the pharmacokinetics (PK) of suptavumab in infants to inform the dose regimen used in Part B of the study. The study protocol specified the process and criteria for assessment of the dose. The dose used in Part B was to remain the same as Part A if the PK data up to Day 57 demonstrated that the individual PK observations were consistent with model-predicted concentrations, following age and body weight corrections.|Day 1 through Day 150|"The PK analysis set included participants who received a single dose of suptavumab and had at least 1 measurable concentration of suptavumab in serum. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specific time point."|||mg/L||Standard Deviation|Mean
2586940|NCT02325713|Secondary|Number of Subjects With Clinically Significant Change From Baseline in Vital Signs, Physical Examinations, Electrocardiogram (ECG) and Laboratory Parameters|Vital signs included oral body temperature, blood pressure and pulse rate. Body weight was recorded for physical examinations. The 12-lead ECGs were recorded after the subjects have rested for at least 5 minutes in supine position. The parameters heart rate (HR), RR, PR, QRS, QT and QTcB calculated by the Bazett formula. Laboratory investigation including chemistry, hematology and urinalysis.|Baseline up to end of treatment (up to Day 32)|The safety population included all randomized subjects who received at least 1 dose of the trial medication and who had follow-up safety assessments.|||subjects|||Number
2586941|NCT02325713|Secondary|Palatability Assessment Based on Visual Analog Scale (VAS) Score|"Palatability was assessed in terms of Flavor, Smell, Sweetness, Overall liking of the medicine, Taste and Acceptability to swallow, each parameter assessed on a 0 to 100 millimeter (mm) visual analog scale (VAS), where 0 indicates Did not like and 100 indicates very much liked. Flavor, Smell, Sweetness and Overall liking of the medicine were evaluated immediately after taking the medication (Day 1, 0 Hour) and Taste and Acceptability to swallow were assessed 2-5 minutes post administration of medication."|Immediately and 2-5 minutes (min) after dosing on Day 1 of each treatment|The safety population included all randomized subjects who received at least 1 dose of the trial medication and who had follow-up safety assessments.|||millimiter (mm)||Standard Deviation|Mean
2586942|NCT02325713|Secondary|Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the stud drug.|Baseline up to end of treatment (up to Day 32)|The safety population included all randomized subjects who received at least 1 dose of the trial medication and who had follow-up safety assessments.|||subjects|||Number
2586943|NCT02325713|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of D-PZQ and Racemate PZQ|AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. AUC0-inf, adj was defined as the AUC0-inf adjusted for the actual administered dose of D-PZQ and Racemate PZQ.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2586957|NCT02325687|Secondary|Incidence of Intraoperative Obstructive Respiratory Events|Incidences of intraoperative obstructive respiratory events will be collected perioperatively in the operating room by the anesthesiologist|Throughout hospital stay, or an average of 1 week.||||participants|||Number
2587042|NCT02324205|Secondary|Lesion Type Observed by FFDM Imaging|Lesions were characterized based on findings identified during image evaluations performed by qualified readers.|Approximately 8 weeks|Participants with lesions evaluated by FFDM. A single participant may have more than one lesion.|||lesions|lesions||Number
2586944|NCT02325713|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/f) of L-PZQ, D-PZQ, and Racemate PZQ|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/f after oral dose was influenced by the fraction absorbed.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|"The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, n signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively."|||Liters||Geometric Coefficient of Variation|Geometric Mean
2586945|NCT02325713|Secondary|Apparent Total Body Clearance of Drug From Plasma (CL/f) of L-PZQ, D-PZQ, and Racemate PZQ|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, “n” signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively.|||Liter/hour||Geometric Coefficient of Variation|Geometric Mean
2586946|NCT02325713|Secondary|Relative Bioavailability (Frel) of L-PZQ, D-PZQ, and Racemate PZQ|Frel was calculated for Treatment A versus Treatment B only. It was calculated by using AUC0-∞, with treatment A as the Test and treatment B as the Reference. Frel = AUC0-inf (test) / AUC0-inf (reference).|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods.|||percent bioavailability||Geometric Coefficient of Variation|Geometric Mean
2586947|NCT02325713|Secondary|Apparent Terminal Elimination Rate Constant (λz) of L-PZQ, D-PZQ, and Racemate PZQ|λz was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, “n” signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2586948|NCT02325713|Secondary|Extrapolated Area Under the Plasma Concentration Curve From Time Tlast to Infinity (AUCextra) of L-PZQ, D-PZQ, and Racemate PZQ|AUCextra was reported in terms of percentage of AUC0-inf.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, “n” signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively.|||percentage of AUC0-inf||Geometric Coefficient of Variation|Geometric Mean
2586949|NCT02325713|Secondary|AUC From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) Adjusted for the Actual Administered Dose (AUC0-t, Adj) of L-PZQ, D-PZQ, and Racemate PZQ||Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2586950|NCT02325713|Secondary|Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-PZQ, D-PZQ, and Racemate PZQ||Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods.|||hours||Full Range|Median
2586951|NCT02325713|Secondary|Apparent Terminal Half-life (t1/2) of L-PZQ, D-PZQ, and Racemate PZQ|Apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination.|Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, “n” signifies those subjects who were evaluable for specified isomers (L-PZQ and D-PZQ) or the racemate mixture of PZQ for each arm, respectively.|||hours||Geometric Coefficient of Variation|Geometric Mean
2586952|NCT02325713|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of L-PZQ, D-PZQ, and Racemate PZQ||Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods.|||hours||Full Range|Median
2586953|NCT02325713|Secondary|Maximum Observed Concentration in Plasma (Cmax) Adjusted for the Actual Administered Dose (Cmax, Adj) of L-PZQ, D-PZQ and Racemate PZQ||Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The PK population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2586954|NCT02325713|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adjusted for the Actual Administered Dose (AUC0-inf, Adj) of L-Praziquantel (L-PZQ)|AUC0-inf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. AUC0-inf, adj was defined as the AUC0-inf adjusted for the actual administered dose of L-PZQ.|Pre-dose,0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 16 and 24 hours post-dose on Day 1 of each treatment|The pharmacokinetic (PK) population included all subjects who completed the study and for whom primary PK parameters could be calculated for the first two treatment periods. Here, ‘N’ (number of participants analyzed) signifies those subjects who were evaluable for this outcome measure.|||Hour*nanograms per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2605731|NCT02107014|Primary|Change in MIG From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2586958|NCT02325687|Secondary|Number of Participants With Respiratory, Cardiac, and/or CNS (Central Nervous System) Complications|We will look at the incidence of respiratory complications (hypoxia; need for respiratory intervention), cardiac complications (MI/ACS or arrhythmias) and CNS (central nervous system) complications (delirium, TIA or CVA). Parameters will be scored for presence or absence over the entire length of stay.|Throughout hospital stay, or an average of 1 week.||||participants|||Number
2586959|NCT02325687|Secondary|Serum and CSF Levels of the Neurotrophins BDNF, IFN-gamma (Interferon Gamma)|CSF (cerebrospinal fluid) was planned to be screened for the differential expression of proteins.The samples have been collected, but the assays have not been performed due to the integrity of the samples.|Intraoperatively - Pre-Incision|||||||
2586960|NCT02325687|Secondary|Serum and CSF (Cerebrospinal Fluid) Levels of the Cytokines TNF-alpha (Tumor Necrosis Factor) , IL-6, IL-8, IL-10 (Interleukin)|Biological samples were collected, but not analyzed for the presence and levels of particular cytokines (TNF-alpha, IL-6, IL-8, IL-10) and neurotrophins (BDNF(brain-derived neurotrophic factor), β-NGF (nerve growth factor)) due to the integrity of the samples.|Intraoperatively - Pre-Incision|||||||
2586961|NCT02325687|Primary|Serum IL-6 (Interleukin 6) Levels|The primary outcome, the levels of cytokine IL-6 in serum of OSA-treated, OSA-untreated and control patients presenting for knee replacement surgery with planned spinal or combined spinal-epidural anesthesia.|Intraoperatively - Pre-Incision|The samples have been collected but the assays have not been performed due to the integrity of the samples.|||pg/mL||Standard Deviation|Mean
2586962|NCT02325518|Secondary|Least Squares Mean Change From Baseline in IOP at 9 AM|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks at 9 AM were pooled, and a negative change indicates an improvement. One eye (target eye) was used for the analysis.|Baseline (Day 0), Week 4, Week 8 at 9 AM|Per Protocol Set (PPS)|||mmHg||95% Confidence Interval|Least Squares Mean
2586963|NCT02325518|Primary|Least Squares Mean Change From Baseline in Intraocular Pressure (IOP) at 11 AM|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks at 11 AM were pooled, and a negative change indicates an improvement. One eye (target eye) was used for the analysis.|Baseline (Day 0), Week 4, Week 8 at 11 AM|This analysis population includes all subjects who received study medication and met inclusion/exclusion criteria prior to randomization (Per Protocol Set).|||mmHg||95% Confidence Interval|Least Squares Mean
2586964|NCT02324972|Secondary|Change From Baseline in Patient Oriented Eczema Measure (POEM) Score|The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) on a scale ranging from 0-4 (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = everyday). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). High scores are indicative of more severe disease and poor quality of life.|12 weeks|The intent to treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
2586965|NCT02324972|Secondary|Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score|The severity scoring of atopic dermatitis (SCORAD) index is a standard tool to assess the atopic dermatitis (AD) severity in clinical studies. Six items; erythema, edema/papulation, oozing/crusts, excoriation, lichenification and dryness are measured on a scale from 0-3 for a total of 18 points, with a higher score indicating greater severity. The percentage of BSA affected by AD is evaluated (percentage divided by 5) and added to the total SCORAD score. Loss of sleep and pruritus are also evaluated by subjects on a visual analog scale (scores ranging from 0-10) with a higher score indicating greater severity. The sum of these measures represents the SCORAD which ranges from 0 (absent disease) to 103 (severe disease).|12 weeks|The intent to treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
2586966|NCT02324972|Secondary|Change From Baseline in Eczema Area and Severity Index (EASI) Score|The Eczema Area and Severity Index (EASI) quantifies the severity of a subject's atopic dermatitis based on both lesion severity and the percentage of body surface area (BSA) affected. Lesions are assessed on four domains; 1) erythema, 2) induration/papulation, 3) excoriation and 4) lichenification. Each domain is scored separately over four body regions (head/neck, upper limbs, trunk and lower limbs) on a scale of 0-3 (0 = none, 1 = mild, 2 = moderate and 3 = severe) with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region relative to the whole body. The sum of these scores provides the EASI total score, ranging from 0 to 72 with a higher score indicating greater severity of atopic dermatitis.|12 weeks|The intent to treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
2586967|NCT02324972|Secondary|Change From Baseline in Investigator's Global Assessment (IGA)|The IGA is a global assessment of the current state of the disease. It is a 5-point morphological assessment of overall disease severity and will be determined according to the following categories: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate) and 4 (severe).|12 weeks|The intent to treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
2586968|NCT02324972|Primary|Change From Baseline in Total Lesion Symptom Score (TLSS)|The TLSS is an assessment of the severity of each of the following three signs: erythema, papulation/infiltration, excoriation and lichenification. Each of these items are rated using a 4-point scale severity where 0 is clear, 1 = mild, 2= moderate and 3 = severe. These ratings are then added to create a total score ranging from 0 to 12|12 weeks|The intent to treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||units on a scale||Standard Deviation|Mean
2586969|NCT02324842|Other Pre-specified|Change in 24-hour Blood Pressure at Study End Compared to Baseline.|Values will be presented as the mean + SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA.|Approximately 4 months||||mmHg||Standard Deviation|Mean
2587043|NCT02324205|Primary|Number of Participants With DBT, FFDM and Biopsy Specimens Collected.|For each participant, obtain image data using two methods (DBT and FFDM) and obtain histology results of biopsy specimens from women referred for biopsy.|Approximately 8 weeks|Initially asymptomatic adult women presenting for breast biopsy based on prior breast imaging.|||Participants|||Count of Participants
2586970|NCT02324842|Other Pre-specified|Change in Total Body Weight at Study End Compared to Baseline|Values will be presented as the mean + SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA. The difference between baseline and study end will represent the change in body weight due to change in hepatic, visceral and abdominal subcutaneous fat.|Approximately 4 months||||kg||Standard Deviation|Mean
2586971|NCT02324842|Other Pre-specified|Change in Plasma Glucagon Concentration at the End of the Study Compared to Baseline|Values will be presented as the mean + SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA.|Approximately 4 months||||mg/ml||Standard Deviation|Mean
2586972|NCT02324842|Other Pre-specified|Change in Free Plasma Insulin at the End of the Study From Baseline Value|Values will be presented as the mean + SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA.|At Approximately 4 months||||mg/ml||Standard Deviation|Mean
2586973|NCT02324842|Other Pre-specified|Change in Matsuda Index of Insulin Sensitivity, Insulin Secretion, and Beta Cell Function During Oral Glucose Tolerance Test (OGTT)|Values will be presented as the mean + SD. The Matsuda Index is a novel assessment of insulin sensitivity that is simple to calculate and provides a reasonable approximation of whole-body insulin sensitivity from the OGTT. The index is calculated from plasma glucose (mg/dl) and insulin (mIU/l) concentrations in both fasting state and post-OGTT. The index value obtained is compared to normal physiologic values to assess insulin sensitivity or resistance. The higher the number, the more insulin sensitive and the lower the number the more insulin resistant the subjects are. Insulin secretion will be measured from plasma C-peptide concentration during the OGTT and the Mari Model will be used to measure beta cell glucose sensitivity|Change from Baseline to Approximately 4 months||||index value||Standard Deviation|Mean
2586974|NCT02324842|Secondary|Body Mass Index (BMI) at 4 Months|A measure of BMI at 4 months to examine effects of combination therapy with liraglutide plus canagliflozin.|Approximately 4 months||||kg/m2||Standard Deviation|Mean
2586975|NCT02324842|Primary|Fasting Plasma Glucose (FPG) at 4 Months|Values will be presented as the mean + (Standard Deviation) SD. The difference in HGP and all secondary endpoints at study end versus baseline will be calculated and compared between each active treatment group with ANOVA.|Baseline to Approximately 4 months||||mg/dl||Standard Deviation|Mean
2586976|NCT02324842|Primary|HbA1c at 4 Months|Primary end point of the study is the HbA1c level in response to canagliflozin alone, liraglutide or canagliflozin with liraglutide.|Approximately 4 months||||percentage glycated hemoglobin||Standard Deviation|Mean
2586977|NCT02324699|Secondary|Change in Calprotectin|Comparison of absolute change in calprotectin from baseline to week 6. Calprotectin is a stool (fecal) test that is used to detect inflammation in the intestines.|baseline, week 6 and week 10|data not collected||||||
2586978|NCT02324699|Secondary|Change in C-Reactive Protein (CRP)|Comparison of absolute change in CRP from baseline to week 10. C-reactive protein is produced by the liver. The level of CRP rises when there is inflammation throughout the body.|baseline and week 10||||mg/L|||Number
2586979|NCT02324699|Secondary|Change in Simple Endoscopic Score for Crohn's Disease (SES-CD)|The SES-CD tool is used to quantify and compare inflammatory load. The Simple Endoscopic Score for Crohn Disease (SES-CD) assesses the size of mucosal ulcers, the ulcerated surface, the endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity.|baseline and week 10||||score on a scale|||Number
2586980|NCT02324699|Primary|Crohn's Disease Activity Index (CDAI)|Clinical remission, defined as CDAI < 150, in group with steroid co-induction vs. placebo co-induction. The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. CDAI scores below 150 indicate a better prognosis than higher scores|baseline, week 6, week 10||||score on a scale|||Number
2586981|NCT02324673|Primary|Number of Participants With Suicide Related Thoughts and Behaviors Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captured the occurrence, severity, and frequency of suicide related thoughts and behaviors at Day 11. The C-SSRS was only used for participants ≥ 7 years of age. The number of participants with results of Yes for Suicidal Ideation (Wish to be Dead and Non-Specific Active Suicidal Thoughts) and Suicidal Behavior (Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior, and Suicidal Behavior) are reported."|Day 11|Participants from the Safety Analysis Population (SAF), all participants who received ≥1 dose of the investigational product, who completed the C-SSRS.|||Participants|||Count of Participants
2586982|NCT02324673|Primary|Change From Baseline in Daily Seizure Activity|The specific number of tonic and atonic seizures per study day were recorded in a diary. The change in number of seizures at Day 11 relative to Baseline is reported. A negative change from Baseline indicates an improvement based on Daily Seizure Activity.|Baseline and Day 11|EFF, all participants who received ≥1 dose of the investigational product and had ≥1 efficacy assessment for number of seizures per day at Day 11.|||number of seizures per day||Standard Deviation|Mean
2586983|NCT02324673|Primary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Assessment|The CGI-S was completed by the parents/caregivers and the Investigator and was used to rate participant's mental illness status at Baseline (Screening) and Day 11 using a 7-point scale, where 1=normal, not mentally ill, and 7=among the most extremely mentally ill participants. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days. The change in CGI-S score at Day 11 relative to Baseline is reported. A negative change from Baseline indicates improvement (decreased severity in illness).|Baseline and Day 11|EFF, all participants who received ≥1 dose of the investigational product and had ≥1 efficacy assessment for CGI-S post-dose.|||scores on a scale||Standard Deviation|Mean
2586984|NCT02324673|Primary|Clinical Global Impression of Improvement (CGI-I) Assessment|The CGI-I was completed by the parents/caregivers and the investigator and was used to assess participants global status of their condition on Day 11 using a 7-point scale, where 1=very much improved and 7=very much worse since the initiation of treatment.|Day 11|Efficacy Analysis Population (EFF), all participants who received ≥1 dose of the investigational product and had ≥1 efficacy assessment for CGI-I post-dose.|||scores on a scale||Standard Deviation|Mean
2586985|NCT02324673|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product. It does not necessarily have a causal relationship with this treatment. A TEAE was defined as any event not present prior to the initiation of the treatment or any event already present that worsens. Any laboratory (clinical chemistry, hematology, urinalysis), 12-lead electrocardiograms, vital signs (temperature, blood pressure, pulse rate, respiratory rate) and physical examination findings deemed by the investigator to be clinically significant were captured as AEs. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires the participant be at a risk of death at the time of the event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, or other serious event that requires medical or surgical intervention.|From the first dose of study drug up to Day 17|Safety Analysis Population (SAF), all participants who received ≥1 dose of the investigational product.|||Participants|||Count of Participants
2586986|NCT02324673|Primary|Time Linearity Index for Cannabidiol and Metabolite 7-OH Cannabidiol in Participants ≥2 Years of Age|"Time linearity index is calculated as the ratio of AUC(0-12) on Day 10/AUC[0-inf] on Day 1.~Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 and Day 10|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for time linearity index.|||ratio||Standard Deviation|Mean
2586987|NCT02324673|Primary|Accumulation Ratio for AUC(0-12) [RAUC(0-12)] on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol|"RAUC(0-12) is the ratio of AUC(0-12) at Day 10 compared to AUC(0-12) at Day 1.~Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for RAUC(0-12).|||ratio||Standard Deviation|Mean
2586988|NCT02324673|Primary|Accumulation Ratio for Cmax (RCmax) on Day 10 for Cannabidiol and Metabolite 7-OH Cannabidiol|"RCmax is the ratio of Cmax at Day 10 compared to Cmax at Day 1.~Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for RCmax.|||ratio||Standard Deviation|Mean
2586989|NCT02324673|Primary|Average Plasma Concentration (Cavg) for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cavg.|||ng/mL||Standard Deviation|Mean
2586990|NCT02324673|Primary|Minimum Plasma Concentration (Cmin) for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmin.|||ng/mL||Standard Deviation|Mean
2586991|NCT02324673|Primary|Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12)/D.|||ng*h/mL/(mg/kg)||Standard Deviation|Mean
2587020|NCT02324569|Secondary|Number of Participants With Markedly Abnormal Values of Laboratory Parameters (Total Bilirubin >2.0) Before Start of Treatment Period II||Up to Week 12|Safety Analysis Set: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period. The analyzed numbers for each arm were participants who were evaluable for this outcome measure..|||Participants|||Count of Participants
2600637|NCT02159950|Primary|Change in Immune Response Assessed by IFN-g ELISPOT Specific for PA2024||Baseline up to 50 weeks|Due a Lack of funding data was not collected and no patients were analyzed.||||||
2586992|NCT02324673|Primary|AUC(0-12) for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 10|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12).|||ng*h/mL||Standard Deviation|Mean
2586993|NCT02324673|Primary|Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 10|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.~MRAUC(0-12) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)."|Day 10 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRAUC(0-12).|||ratio||Standard Deviation|Mean
2586994|NCT02324673|Primary|Metabolite to Parent Ratio for AUC(0-12) [MRAUC(0-12)] on Day 1|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.~MRAUC(0-12) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRAUC(0-12).|||ratio||Standard Deviation|Mean
2586995|NCT02324673|Primary|Metabolite to Parent Ratio for AUC(0-inf) [MRAUC(0-inf)] on Day 1 for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis.~MRAUC(0-inf) was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRAUC(0-inf).|||ratio||Standard Deviation|Mean
2586996|NCT02324673|Primary|MRCmax on Day 10|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose.~MRCmax was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for metabolite to parent ratio.|||ratio||Standard Deviation|Mean
2586997|NCT02324673|Primary|Metabolite (7-OH Cannabidiol) to Parent (Cannabidiol) Ratio for Cmax [MRCmax] on Day 1|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose.~MRCmax was adjusted for molecular weight differences between cannabidiol (341.46) and 7-OH cannabidiol (330.46)."|Day 1 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for MRCmax.|||ratio||Standard Deviation|Mean
2586998|NCT02324673|Primary|Dose Normalized AUC(0-inf) [AUC(0-inf)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-inf)/D.|||ng*h/mL/(mg/kg)||Standard Deviation|Mean
2587021|NCT02324569|Secondary|Number of Participants With Markedly Abnormal Values of ECG Parameters Before Start of Treatment Period II|"Here QTcF is Corrected QT interval by Fridericia formula, and msec is millisecond."|Up to Week 12|Safety Analysis Set: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period. The analyzed numbers for each arm were participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2601697|NCT02150837|Secondary|Lean Mass|Lean mass expressed as an absolute change from baseline.|24 weeks|Not all subjects were remaining at 24 weeks and not all had measurement performed.|||Pounds||Standard Deviation|Mean
2586999|NCT02324673|Primary|AUC From Time 0 to Infinity [AUC(0-inf)] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-inf).|||ng*h/mL||Standard Deviation|Mean
2587000|NCT02324673|Primary|AUC From Time 0 to the Last Quantifiable Concentration [AUC(0-last)] on Day 1 for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1 for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-last).|||ng*h/mL||Standard Deviation|Mean
2587001|NCT02324673|Primary|Dose Normalized AUC(0-12) [AUC (0-12)/D] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose."|Day 1 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12)/D.|||ng*h/mL||Standard Deviation|Mean
2587002|NCT02324673|Primary|Area Under the Plasma-Concentration Time Curve From 0 to 12 Hours Post-dose [AUC(0-12)] for Cannabidiol and Metabolite 7-OH Cannabidiol on Day 1|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose."|Day 1 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for AUC(0-12).|||ng*h/mL||Standard Deviation|Mean
2587003|NCT02324673|Primary|Volume of Distribution (Vz/F) of Cannabidiol for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Vz/F.|||L/kg||Standard Deviation|Mean
2587004|NCT02324673|Primary|Oral Clearance (CL/F) for Cannabidiol for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for CL/F.|||Liters (L)/h/kg||Standard Deviation|Mean
2587005|NCT02324673|Primary|Elimination Rate (Lambda-z [λz]) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for λz.|||1/h||Standard Deviation|Mean
2587006|NCT02324673|Primary|Half Life (t1/2) for Cannabidiol and Metabolite 7-OH Cannabidiol for Participants ≥2 Years of Age|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose; Participants ages 1 to <2 years were not included in this analysis."|Day 1 at age-specific times|Participants ≥2 years from the PK Population who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for t1/2.|||h||Standard Deviation|Mean
2601698|NCT02150837|Secondary|Lean Mass|Lean mass expressed as an absolute change from baseline.|20 weeks||||Pounds||Standard Deviation|Mean
2587007|NCT02324673|Primary|Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for tmax.|||h||Full Range|Median
2587008|NCT02324673|Primary|Time to Cmax (Tmax) for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24, 36, 48 and 72 hours post-dose."|Day 1 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for tmax.|||hours (h)||Full Range|Median
2587009|NCT02324673|Primary|Cmax/D for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.|||ng/mL/(mg/kg)||Standard Deviation|Mean
2587010|NCT02324673|Primary|Dose Normalized Cmax (Cmax/D) for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17: Day 1 pre-dose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose."|Day 1 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.|||ng/mL/(mg/kg)||Standard Deviation|Mean
2587011|NCT02324673|Primary|Cmax for Cannabidiol and Metabolite 7-OH Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 10 pre-dose and at 2, 4, 8 and 12 hours post-dose; Participants ages 2 to <6 years: Day 10 pre-dose and at 1, 2, 3, 4, 8, 12 and 24 hours post-dose; Participants ages 6 to ≤17 years: Day 10 pre-dose and at 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose."|Day 10 at age-specific times|PK Population, all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.|||ng/mL||Standard Deviation|Mean
2587012|NCT02324673|Primary|Maximum Plasma Concentration (Cmax) for Cannabidiol and Metabolite 7-hydroxy (7-OH) Cannabidiol|"Serial blood sample collection times for pharmacokinetic (PK) analysis were based on the participant's age as follows:~Participants ages 1 to <2 years: Day 1 at 2, 4, 8, 12 hours post-dose; Participants ages 2 to <6 years: Day 1 pre-dose and at 1, 2, 3, 4, 8, 12, 16, 24 and 48 hours post-dose; Participants ages 6 to ≤17 years: Day 1 pre-dose and at 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose."|Day 1 at age-specific times|Pharmacokinetic population (PK), all participants who received ≥1 dose of study drug and had ≥1 post-dose measured plasma concentration of cannabidiol and/or 7-OH cannabidiol with evaluable PK data available for analysis. The number of participants in each category is the number of participants with evaluable PK data available for Cmax.|||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
2587013|NCT02324660|Other Pre-specified|Cardiac Death|occurrence of cardiac death|1 year|||||||
2587014|NCT02324660|Other Pre-specified|Adverse Events|hospital admission for ACS, for bleeding complications, for respiratory failure, for arrhytmias, for pneumonia|1 year after inclusion|||||||
2587015|NCT02324660|Secondary|Undiagnosed COPD|percentage of patients admitted to hospital for ACS and with undiagnosed COPD|2 months|||||||
2587016|NCT02324660|Secondary|Cardiac Adverse Events|cumulative occurrence of death, myocardial infarction and heart failure|1 year after inclusion||||partecipants|||Number
2587017|NCT02324660|Primary|COPD Diagnosis|COPD diagnosis confirmed by spirometry|2 months after inclusion||||participants|||Number
2587018|NCT02324569|Secondary|Change From Baseline in Self-Monitoring of Blood Glucose Before Breakfast|Reported data was the change from baseline in self-monitoring of blood glucose before breakfast.|Baseline and Day 2, 3, 4, 5, 6, 7, and 8 in each Treatment Period (I and II) (Totally up to Week 17)|Safety Analysis Set: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at the given time point.|||mg/dL||Standard Deviation|Mean
2587019|NCT02324569|Secondary|Number of Participants With Total Hypoglycaemia After 1st Dose of Study Drug and Before Start of Treatment Period II||Up to Week 53|Safety Analysis Set: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period. The analyzed numbers for each arm were participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2587040|NCT02324205|Secondary|Maximum Lesion Dimension as Observed by FFDM|Maximum Length of Lesions (measured in mm) when images were collected using FFDM.|Approximately 8 weeks|Lesions observed and measured when images were collected when using FFDM; Seven (7) of the total 173 observed lesions were not measured.|||millimeters (mm)|lesions|Standard Deviation|Mean
2587022|NCT02324569|Secondary|Number of Participants With Markedly Abnormal Values of Vital Signs Before Start of Treatment Period II|"Here mmHg is Millimeter of mercury."|Up to Week 12|Safety Analysis Set: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period. The analyzed numbers for each arm were participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2587023|NCT02324569|Secondary|Change From Baseline in Plasma Glucose Measured by the Meal Tolerance Test in Treatment Period I|Reported data was the change from pre-meal in plasma glucose measured by the meal tolerance test at each time point.|Pre-meal and 0.5, 1, and 2 hr after-meal at Week 0 and 0.5, 1, and 2 hr after-meal at the End of Treatment Period I (Up to Week 12)|Full Analysis Set: All randomized participants who received at least one dose of study drug. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at the given time point.|||mg/dL||Standard Deviation|Mean
2587024|NCT02324569|Secondary|Change From Baseline in Fasting Plasma Glucose|Reported data was the change from baseline in fasting plasma glucose at each time point.|Baseline and Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 53, End of Treatment Period I (Up to Week 12) and End of Treatment Period II (Up to Week 52)|Full Analysis Set: All randomized participants who received at least one dose of study drug. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at the given time point.|||mg/dL||Standard Deviation|Mean
2587025|NCT02324569|Secondary|Change From Baseline in HbA1c|Reported data was the change from baseline in HbA1c at each time point.|Baseline and Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, End of Treatment Period I (Up to Week 12) and End of Treatment Period II (Up to Week 52)|Full Analysis Set: All randomized participants who received at least one dose of study drug. The analyzed numbers for each arm were participants who were evaluable for this outcome measure at the given time point.|||Percent||Standard Deviation|Mean
2587026|NCT02324569|Primary|Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs) That Occurred Before Start of Treatment Period II|Reported data is the number of participants reporting one or more TEAEs that occurred before start of Treatment Period II in Treatment Group I and Treatment Group II.|Up to Week 12|Safety Analysis Set: The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
2587027|NCT02324569|Primary|Change in HbA1c From Baseline at the End of Treatment Period I (End of Treatment Period I − End of the Screening Period)||End of the screening period (Week 0) and End of Treatment Period I (Up to Week 12)|Full Analysis Set: All randomized participants who received at least one dose of study drug.|||Percent||Standard Error|Least Squares Mean
2587028|NCT02324504|Primary|Number of Participants With Successful Placement of Peripherally Inserted Central Catheter (PICC)|"Successful placement (based upon review of chest radiograph) of the PICC as determined by the tip location of:~RA SVC junction (right atrium/superior vena cava) or~Distal or lower SVC"|Less than 24 hours||||Participants|||Count of Participants
2587029|NCT02324465|Other Pre-specified|Number of Participants With Adverse Events|Notation of any injury to lips, teeth, soft tissue.|during and immediately after procedure (approx 180 minutes)||||participants|||Number
2587030|NCT02324465|Secondary|Total Number of Assisted Maneuvers Required to Complete Intubation (Includes All Participants in Arm)|Assisted Maneuvers can include laryngeal manipulation, head lift, Backward Upward Rightward Pressure, stylet removed, Cricoid pressure, scope manipulation and bougie.|<100 seconds||||assisted maneuvers|||Number
2587031|NCT02324465|Secondary|Mean Pulse Oximetry Saturation Value Reading During Intubation||<100 seconds||||percentage of oxygen saturation||Full Range|Mean
2587032|NCT02324465|Primary|Time Until Intubation With Each Device|time from the introduction of the laryngoscope into the oral cavity to endotracheal tube reaching the glottic aperture|<100 seconds||||seconds||Full Range|Mean
2587033|NCT02324335|Secondary|Time to Onset of Severe Oral Mucositis (WHO Grade ≥3)|Time to onset of severe oral mucositis (WHO Grade ≥3) analyzed using Kaplan-Meier methods.|7 weeks|"Data is presented for all subjects (censored and uncensored) in the mITT population, with a censored outcome reported as NA."|||days||Full Range|Median
2587034|NCT02324335|Secondary|Incidence of Severe Oral Mucositis (WHO Grade ≥3) for Subjects Receiving Cisplatin Every 21 Days|Incidence of severe oral mucositis (WHO Grade ≥3) for subjects receiving cisplatin every 21 days|7 weeks|Subgroup of subjects receiving cisplatin every 21 days|||Participants|||Count of Participants
2587035|NCT02324335|Secondary|Duration of Severe Oral Mucositis (WHO Grade ≥3) [Overall Duration]|Overall duration of severe OM was defined as the number of days from initial WHO Grade ≥3 during radiation therapy to the day prior to the next OM assessment after the last WHO Grade ≥3 during/after radiation therapy.|11 weeks||||Days||Full Range|Median
2587036|NCT02324335|Primary|Incidence of Severe OM During Radiation Therapy in Subjects Receiving a Cumulative IMRT Dose of at Least 55 Gy|Incidence of severe oral mucositis, defined as grade 3 or 4 on the WHO Oral Mucositis score, experienced during radiation therapy by patients with head and neck cancer receiving a cumulative radiation dose of at least 55 Gy. The higher the score the more severe the mucositis.|7 weeks|mITT Population included all randomized subjects who received at least one dose of study drug and a cumulative radiation dose of at least 55 Gy (and no more than 72 Gy)|||Participants|||Count of Participants
2587037|NCT02324205|Other Pre-specified|Safety - Device Related Malfunctions|Number of device-related malfunctions by imaging modality.|less than 16 months|Number of device malfunctions recorded for either DBT or FFDM imaging.|||malfunction events reported|||Number
2587038|NCT02324205|Secondary|Biopsy Finding of Lesions Per Subject.|Describes histologic cancer and non-cancer findings of lesion biopsy. Cancer status of lesions was reported per subject, not per lesion.|Approximately 8 weeks|"All lesions with a biopsy finding: positive/malignant, negative/benign or non-conclusive. Biopsy findings were reported per subject, not per lesion."|||participants|||Number
2587039|NCT02324205|Secondary|Maximum Lesion Dimension as Observed by DBT|Maximum length of lesions (measured in mm) when images were collected using DBT|Approximately 8 weeks|Lesions observed and measured when images were collected using DBT. Sixteen (16) of the total 192 observed lesions were not measured.|||millimeters (mm)|Lesions|Standard Deviation|Mean
2587084|NCT02322892|Other Pre-specified|Pyruvate Dehydrogenase (PDH) Enzyme Activity|PDH activity will be measured in isolated peripheral blood mononuclear cells using a novel immunocapture and microplate-based method|Six hours after end of surgery surgery|||||||
2587044|NCT02324075|Secondary|Number of Pans With Presence of Visible Feces Inside Hole of the Pan|Assessment by observer in unannounced visit to the shared latrine to determine presence of visible feces inside the hole of the pan.|baseline and 6 months post intervention|Shared latrines may have had more than one cubicle with waste pan. Pans that were evaluated were included in the analysis.|||pans|pans||Count of Units
2587045|NCT02324075|Secondary|Number of Unclean Cubicles|Assessment by observer in unannounced visit to the shared latrine to determine problems with cleanliness. Observations were made for spit/cough on walls/doors, cigarette butts, waterlogging, household or polythene-wrapped waste, rags/sanitary pads, smell of feces, smell of urine, and smell of cigarettes. The count of units that had the problem is presented for each problem type.|baseline and 6 months post intervention|Shared latrines may have had more than one cubicle. Cubicles that were evaluated were included in the analysis.|||Cubicles|Cubicles||Count of Units
2587046|NCT02324075|Secondary|Number of Functional Cubicle Toilets|Assessment by observer in unannounced visit to the shared latrine to determine if the cubicle toilet is fully functional.|baseline and 6 months post intervention|Shared latrines may have had more than one cubicle toilet. Toilets that were evaluated were included in the analysis.|||toilets|toilets||Count of Units
2587047|NCT02324075|Secondary|Visible Feces Near the Latrine But Not on the Path|Assessment by observer in unannounced visit to the shared latrine to determine presence of feces near the latrine but not on the path leading to the latrine.|baseline and 6 months post intervention|Data were not collected for this outcome measure.||||||
2587048|NCT02324075|Secondary|Visible Feces on the Path Leading up to the Latrine|Assessment by observer in unannounced visit to the shared latrine to determine presence of feces on the path leading up to the shared toilet.|baseline and 6 months post intervention||||Shares latrines|Shares latrines||Count of Units
2587049|NCT02324075|Secondary|Number of Pans With Presence of Visible Feces Outside the Pan|Assessment by observer in unannounced visit to the shared latrine to determine presence of visible feces outside the pan.|baseline and 6 months post intervention|Shared latrines may have had more than one cubicle with waste pan. Pans that were evaluated were included in the analysis.|||pans|pans||Count of Units
2587050|NCT02324075|Primary|Number of Pans With Presence of Visible Feces Inside the Pan|Assessment by observer in unannounced visit to the shared latrine to determine presence of visible feces inside the pan (both inside and outside the hole in the pan).|baseline and 6 months post intervention|Shared latrines may have had more than one cubicle with waste pan. Pans that were evaluated were included in the analysis.|||pans|pans||Count of Units
2587051|NCT02324049|Primary|Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)|TEAEs were defined as any adverse event (AE) that occurred after administration of the first dose of study drug on Day 1 (Part A). A severe AE was defined as an AE that was incapacitating and required medical intervention. TEAEs were summarized cumulatively over the entire study and separately for Part C, data for all severe TEAEs throughout the entire study is presented. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline to Week 142|Safety Population: all participants for whom informed consent had been obtained, who had a confirmed diagnosis of MPS IIIB, and who had received any amount of SBC-103.|||Participants|||Count of Participants
2587052|NCT02323854|Secondary|Number of Participants With Complete or Incomplete Tumor Ablation|The secondary endpoint was complete tumor ablation immediately post-procedure for each target tumor using histologic analysis. Complete ablation was defined as 100% nonviable tumor cells.|Same Day|Secondary endpoint results were available for 11 subjects. For the secondary results, there were no tumors in four out of 15 samples (26.6%). Therefore, assessment of tumor cannot be made.|||Participants|||Count of Participants
2587053|NCT02323854|Primary|Ablation Zone Shape|Ablation width (X) / height (Y), ratio of 1 indicates spherical ablation zone shape|Same day|Primary endpoint results were available for 11 subjects. Four out of 15 (26.6%) imaging sets were either not obtained or unable to be evaluated.|||Ratio||Standard Deviation|Mean
2587054|NCT02323854|Primary|Dose Response|Dose response was assessed by comparing actual ablation zone size and volume to predicted ablation zone size and volume prescribed by the physician using the Emprint™ Procedure Planning Application. Dose response was measured for each ablation zone using CT imaging immediately post ablation and prior to the surgical resection.|1 Day|Primary endpoint results were available for 11 subjects. Four out of 15 (26.6%) imaging sets were either not obtained or unable to be evaluated.|||percent difference||Standard Deviation|Mean
2587055|NCT02323646|Secondary|Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2|The total uterine fibroid volume was measured by Magnetic Resonance Imaging (MRI). A negative change from Baseline indicates improvement.|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1 and the end of 18-weeks Treatment Course 2|ITT population included all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.|||percentage change in fibroid volume||Standard Deviation|Mean
2587056|NCT02323646|Secondary|Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit|"UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 8: During the previous 3 months how distressed were you by feeling fatigued? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.|||percentage change in UFS-SSS score||Standard Deviation|Mean
2587085|NCT02322892|Other Pre-specified|Lactate Levels||Six hours after end of surgery surgery|||||||
2587086|NCT02322892|Secondary|Mortality||Until hospital discharge, limit 60 days||||participants|||Number
2587087|NCT02322892|Secondary|Length of Stay|Duration of intensive care unit stay|Until hospital discharge, limit 60 days||||days||Inter-Quartile Range|Median
2587088|NCT02322892|Secondary|Patients With Post-operative Complications|Atrial fibrillation, delirium, renal failure, stroke, myocardial infarction, acute respiratory distress syndrome, infection|Until hospital discharge, limit 60 days||||participants|||Number
2587057|NCT02323646|Secondary|Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit|"UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 7: During the previous 3 months how distressed were you by frequent nighttime urination? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.|||percentage change in UFS-SSS score||Standard Deviation|Mean
2587058|NCT02323646|Secondary|Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit|"UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 6: During the previous 3 months how distressed were you by frequent urination during the daytime hours? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.|||percentage change in UFS-SSS score||Standard Deviation|Mean
2587059|NCT02323646|Secondary|Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit|"UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 5: During the previous 3 months how distressed were you by feeling tightness or pressure in your pelvic area? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.|||percentage change in UFS-SSS score||Standard Deviation|Mean
2587060|NCT02323646|Secondary|Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit|"UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 4: During the previous 3 months how distressed were you by fluctuation in the length of your monthly cycle compared to your previous cycles? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.|||percentage change in UFS-SSS score||Standard Deviation|Mean
2587061|NCT02323646|Secondary|Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit|"UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 3: During the previous 3 months how distressed were you by fluctuation in the duration of your menstrual period compared to your previous cycle? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.|||percentage change in UFS-SSS score||Standard Deviation|Mean
2587062|NCT02323646|Secondary|Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit|"UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 2: During the previous 3 months how distressed were you by passing blood clots during your menstrual period? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.|||percentage change in UFS-SSS score||Standard Deviation|Mean
2587063|NCT02323646|Secondary|Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit|"UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 1: During the previous 3 months how distressed were you by heavy bleeding during your menstrual period? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.|||percentage change in UFS-SSS score||Standard Deviation|Mean
2587089|NCT02322892|Secondary|Percentage Change From Baseline in Pyruvate Dehydrogenase (PDH) Enzyme Activity|PDH activity will be measured in isolated peripheral blood mononuclear cells using a novel immunocapture and microplate-based method. Reported as relative change from before the surgery.|Post-surgery within 1 hour of arrival to the ICU||||Percent change from baseline||Inter-Quartile Range|Median
2587064|NCT02323646|Secondary|Percentage Change in Transformed Total Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2 and the Course 2 Week 24 Follow-up Visit|UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. Each question was answered on a 5-point scale where 1=Not at all to 5=A very great deal. The sum of the total scores was transformed to a range of 0=no symptoms (best) to 100=most severe symptoms (worst). A negative percentage change from Baseline indicates improvement.|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 Follow-up Visit|ITT population included all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.|||percentage change in UFS-SSS score||Standard Deviation|Mean
2587065|NCT02323646|Secondary|Percentage Change in PBAC Scores From Baseline to the End of Treatment Courses 1 and 2|Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss. Participants recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Pictorial scores range from score 1 for slightly stained tampon/towel, 5 for a partially stained tampon/towel, 10 for a completely saturated tampon, 20 for a completely saturated towel, and 5 for each episode of flooding and for each blood clot larger than a quarter in size. Total score can range from 0 (no bleeding) to >500. Higher scores indicate more bleeding. Lower scores indicate less bleeding. A negative change from Baseline indicates improvement (reduction in bleeding).|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1 and the end of 18-weeks Treatment Course 2|ITT population included all participants who were randomized and received study drug. Number analyzed is the number of participants with data available at the given time-point.|||percentage change in PBAC score||Standard Deviation|Mean
2587066|NCT02323646|Secondary|Percentage of Participants in Amenorrhea at the End of Treatment Course 2|Amenorrhea was defined as any 28-day period during treatment (not including the ODI) without a bleeding intensity score >1 after 2 courses of treatment. Participants were provided with a daily diary and (PBAC) to record information about the MBL. Bleeding intensity was graded on a 5-point scale where: 1=spotting to 5=heavy bleeding.|At the end of 18-weeks Treatment Course 2|ITT population included all participants who were randomized and received study drug.|||percentage of participants|||Number
2587067|NCT02323646|Primary|Percentage of Participants in Amenorrhea at the End of Treatment Course 1|Amenorrhea was defined as any 28-day period during treatment (not including the ODI) without a bleeding intensity score >1. Participants were provided with a daily diary and Pictorial Blood Loss Assessment Chart (PBAC) to record information about the menstrual blood loss (MBL). Bleeding intensity was graded on a 5-point scale where: 1=spotting to 5=heavy bleeding.|At the end of 18-weeks Treatment Course 1|Intent-to-Treat (ITT) population included all participants who were randomized and received study drug.|||percentage of participants|||Number
2587068|NCT02323204|Primary|Implementation Through the First and Last Survey Administered Post-Baseline|Implementation was measured on a scale ranging from 0 to 2, where a score of 0 is indicative of no implementation, a score of 1 indicative of partial implementation, and 2 of full implementation. For the trauma education group, a score of 0 was assigned if the subject never read the provided materials, a score of 1 was assigned if participants read but did not use the provided materials, and a score of 2 was assigned if the participant read and used the material at least once. For the link group, a score of 0 was assigned if the subject did not use any of the skills associated with the intervention, a score of 1 was assigned if at least one but not all three skills were used, and a score of 2 was assigned if all skills were used.|surveys were provided at 6 weeks, 3 months, and 6 months post-baseline|Subjects who completed the baseline questionnaire and at least one questionnaire post-baseline were eligible for analyses. Only those parents who submitted responses to implementation-related questions were included in these analyses.|||units on a scale||Standard Deviation|Mean
2587069|NCT02323204|Primary|Prosocial Behavior (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline|Prosocial Behavior (SDQ Subscale) (modified). Lower scores are preferable. Scores may range from 1 to 11. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves.|surveys were provided at 6 weeks, 3 months, and 6 months post-baseline|Subjects who completed the baseline questionnaire and at least one questionnaire post-baseline were eligible for analyses. Of these, only those subjects whose data were observed or could be imputed were used in the fitting of Generalized Linear Mixed Models (GLMMs). Means and standard deviations were computed using observed data only.|||units on a scale||Standard Deviation|Mean
2587070|NCT02323204|Primary|Peer Relationship Problems (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline|Peer Problems (SDQ Subscale) (modified). Lower scores are preferable. Scores may range from 1 to 11. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves.|surveys were provided at 6 weeks, 3 months, and 6 months post-baseline|Subjects who completed the baseline questionnaire and at least one questionnaire post-baseline were eligible for analyses. Of these, only those subjects whose data were observed or could be imputed were used in the fitting of Generalized Linear Mixed Models (GLMMs). Means and standard deviations were computed using observed data only.|||units on a scale||Standard Deviation|Mean
2587071|NCT02323204|Primary|Hyperactivity (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline|Hyperactivity (SDQ Subscale) (modified). Lower scores are preferable. Scores may range from 1 to 11. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves.|surveys were provided at 6 weeks, 3 months, and 6 months post-baseline|Subjects who completed the baseline questionnaire and at least one questionnaire post-baseline were eligible for analyses. Of these, only those subjects whose data were observed or could be imputed were used in the fitting of Generalized Linear Mixed Models (GLMMs). Means and standard deviations were computed using observed data only.|||units on a scale||Standard Deviation|Mean
2587090|NCT02322892|Primary|Lactate Levels||Post-surgery within 1 hour of arrival to the ICU|Modified intention to treat|||mmol/L||Inter-Quartile Range|Median
2587119|NCT02322814|Primary|Cohort II, III: Percentage of Participants With Confirmed Overall Response (OR) (Partial Response [PR] or Complete Response [CR]), as Determined by the Investigator Using RECIST v1.1||Randomization up to disease progression or relapse, whichever occurs first (up to approximately 3.5 years)||||Percentage|||Number
2587072|NCT02323204|Primary|Conduct Problems (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline|Conduct Problems (SDQ Subscale) (modified). Lower scores are preferable. Scores may range from 1 to 11. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves.|surveys were provided at 6 weeks, 3 months, and 6 months post-baseline|Subjects who completed the baseline questionnaire and at least one questionnaire post-baseline were eligible for analyses. Of these, only those subjects whose data were observed or could be imputed were used in the fitting of Generalized Linear Mixed Models (GLMMs). Means and standard deviations were computed using observed data only.|||units on a scale||Standard Deviation|Mean
2587073|NCT02323204|Primary|Emotional Symptoms (SDQ Subscale) Through the First and Last Survey Administered Post-Baseline|Emotional Symptoms (SDQ Subscale) (modified). Lower scores are preferable. Scores may range from 1 to 11. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves.|surveys were provided at 6 weeks, 3 months, and 6 months post-baseline|Subjects who completed the baseline questionnaire and at least one questionnaire post-baseline were eligible for analyses. Of these, only those subjects whose data were observed or could be imputed were used in the fitting of Generalized Linear Mixed Models (GLMMs). Means and standard deviations were computed using observed data only.|||units on a scale||Standard Deviation|Mean
2587074|NCT02323204|Primary|Strengths and Difficulties (Questionnaire to Assess Internalizing and Externalizing Behaviors (SDQ)) Through the First and Last Survey Administered Post-Baseline|Strengths and Difficulties (Questionnaire to Assess Internalizing and Externalizing Behaviors (SDQ)) (modified). Lower scores are preferable. Scores may range from 1 to 41. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves.|surveys were provided at 6 weeks, 3 months, and 6 months post-baseline|Subjects who completed the baseline questionnaire and at least one questionnaire post-baseline were eligible for analyses. Of these, only those subjects whose data were observed or could be imputed were used in the fitting of Generalized Linear Mixed Models (GLMMs). Means and standard deviations were computed using observed data only.|||units on a scale||Standard Deviation|Mean
2587075|NCT02323204|Primary|Psychological Distress Symptoms (Kessler Screening Scale for Psychological Distress (K6)) Through the First and Last Survey Administered Post-Baseline|Psychological Distress Symptoms (Kessler Screening Scale for Psychological Distress (K6)) (modified). Lower scores are preferable. Scores may range from 1 to 25. Responses submitted by parents are with respect to themselves. Responses submitted by children are with respect to themselves.|surveys were provided at 6 weeks, 3 months, and 6 months post-baseline|Subjects who completed the baseline questionnaire and at least one questionnaire post-baseline were eligible for analyses. Of these, only those subjects whose data were observed or could be imputed were used in the fitting of Generalized Linear Mixed Models (GLMMs). Means and standard deviations were computed using observed data only.|||units on a scale||Standard Deviation|Mean
2587076|NCT02323204|Primary|Quality of Life (Questionnaire) Through the First and Last Survey Administered Post-Baseline|Quality of Life, a questionnaire (modified). Lower scores are preferable. Scores may range from 1 to 101. Responses submitted by parents are with respect to their children. Responses submitted by children are with respect to themselves.|surveys were provided at 6 weeks, 3 months, and 6 months post-baseline|Subjects who completed the baseline questionnaire and at least one questionnaire post-baseline were eligible for analyses. Of these, only those subjects whose data were observed or could be imputed were used in the fitting of Generalized Linear Mixed Models (GLMMs). Means and standard deviations were computed using observed data only.|||units on a scale||Standard Deviation|Mean
2587077|NCT02323204|Primary|Depressive Symptoms (Center for Epidemiologic Studies Depression Scale (CES-D) Through the First and Last Survey Administered Post-Baseline|Center for Epidemiologic Studies Depression Scale (CES-D) (modified), a questionnaire. Lower scores are preferable. Scores may range from 1 to 31. Responses submitted by parents are with respect to themselves. Responses submitted by children are with respect to themselves.|surveys were provided at 6 weeks, 3 months, and 6 months post-baseline|Subjects who completed the baseline questionnaire and at least one questionnaire post-baseline were eligible for analyses. Of these, only those subjects whose data were observed or could be imputed were used in the fitting of Generalized Linear Mixed Models (GLMMs). Means and standard deviations were computed using observed data only.|||units on a scale||Standard Deviation|Mean
2587078|NCT02323204|Primary|Post-traumatic Stress Symptoms (Child Post-traumatic Stress Disorder (PTSD) Scale) Through the First and Last Survey Administered Post-Baseline|Post-traumatic stress disorder (PTSD) (modified) scale, a questionnaire. Lower scores are preferable. Scores may range from 1 to 52. Responses submitted by parents are with respect to themselves. Responses submitted by children are with respect to themselves.|surveys were provided at 6 weeks, 3 months, and 6 months post-baseline|Subjects who completed the baseline questionnaire and at least one questionnaire post-baseline were eligible for analyses. Of these, only those subjects whose data were observed or could be imputed were used in the fitting of Generalized Linear Mixed Models (GLMMs). Means and standard deviations were computed using observed data only.|||units on a scale||Standard Deviation|Mean
2587079|NCT02323048|Primary|"Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire"|"The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: Feel Drug, Feel High, Like Drug, and Want More. The Feel Drug, Feel High, Like Drug, and Want More subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome."|End of study (time 0 and approximately 4 weeks later)||||units on a scale||Standard Deviation|Mean
2587080|NCT02322892|Other Pre-specified|Cellular Oxygen Consumption|Cellular (peripheral blood mononuclear cells) oxygen consumption measured with the XFe24 Extracellular Flux Analyzers|Post-surgery within 1 hour of arrival to the ICU|||||||
2587081|NCT02322892|Other Pre-specified|Global Oxygen Consumption (VO2)|VO2 will be measured with a Compact Anesthesia monitor|From arrival to ICU to extubation, limit 6 hours|||||||
2587082|NCT02322892|Other Pre-specified|Time on Vasopressors||Limit 60 days|||||||
2587083|NCT02322892|Other Pre-specified|Time on Mechanical Ventilation||Limit 60 days|||||||
2601699|NCT02150837|Secondary|Lean Mass|Lean mass expressed as an absolute change from baseline.|16 weeks||||Pounds||Standard Deviation|Mean
2587091|NCT02322879|Primary|Rise in Plasma Transaminases: Proportion of Responders.|Blood tests to monitor Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) were obtained on every visit prior dosing. ALT and AST were analyzed on a Roche Cobas c501 chemistry module at BIDMC. Responders was defined as peak ALT increased 2x baseline (average of first 3 days)|Daily during the treatment periods (D1-D14 and D29 to 42)||||Participants|||Count of Participants
2587092|NCT02322866|Secondary|Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 3|ITT Population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
2587093|NCT02322866|Secondary|Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 6|ITT Population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
2587094|NCT02322866|Secondary|Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 9|ITT Population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
2587095|NCT02322866|Secondary|Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 3|ITT Population included all randomized participants.|||percent change in lesion counts||Standard Error|Least Squares Mean
2587096|NCT02322866|Secondary|Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 6|ITT Population included all randomized participants.|||percent change in lesion counts||Standard Error|Least Squares Mean
2587097|NCT02322866|Secondary|Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 9|ITT Population included all randomized participants.|||percent change in lesion counts||Standard Error|Least Squares Mean
2587116|NCT02322814|Secondary|Cohort I, II, III: Duration of Response (DOR), as Determined by the Investigator Using RECIST v1.1||Time from the first occurrence of documented objective response to time of relapse or death, whichever occurs first (up to approximately 5.5 years)||2021-04-30|04/2021||||
2587098|NCT02322866|Secondary|Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Facial inflammatory lesions (pustules, papules, and nodular lesions) were counted and recorded separately. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 12|ITT Population included all randomized participants.|||percent change in lesion counts||Standard Error|Least Squares Mean
2587099|NCT02322866|Primary|Percentage of Participants With Investigator's Global Assessment (IGA) Scale Success at Week 12|The investigator assessed the participant's inflammatory lesions on the face using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. Success was defined as at least a 2-point decrease (improvement) from Baseline on the IGA assessment as well as a score of clear (0) or almost clear (1). The percentage of participants who achieved success is reported. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Week 12|ITT Population included all randomized participants.|||percentage of participants|||Number
2587100|NCT02322866|Primary|Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 12|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on analysis of covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 12|ITT Population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
2587101|NCT02322814|Secondary|Cohort II, III: AUC0-tau (in Serum) of Atezolizumab||Safety Run-In, Expansion: Predose (Hr 0), 0.5 Hr postdose (infusion duration: 1 Hr) on D1 of Cy1, 3; predose (Hr 0) on D1 of Cy2, 4, 8, every 8 Cy up to EOT (approximately 5.5 years); 120 days after EOT (approximately 5.5 years) (Cy=28 days)||2021-04-30|04/2021||||
2587102|NCT02322814|Secondary|Cohort II, III: Cmin (in Serum) of Atezolizumab||Safety Run-In, Expansion: Predose (Hr 0), 0.5 Hr postdose (infusion duration: 1 Hr) on D1 of Cy1, 3; predose (Hr 0) on D1 of Cy2, 4, 8, every 8 Cy up to EOT (approximately 5.5 years); 120 days after EOT (approximately 5.5 years) (Cy=28 days)||2021-04-30|04/2021||||
2587103|NCT02322814|Secondary|Cohort II, III: Cmax (in Serum) of Atezolizumab||Safety Run-In, Expansion:Predose (Hr0), 0.5Hr postdose (infusion duration:1Hr) on D1 of Cy1, 3; predose (Hr0) on D1 of Cy2, 4, 8, every 8 Cy up to end of treatment (EOT) (approximately 5.5 years); 120 days after EOT (approximately 5.5 years) (Cy=28 days)||2021-04-30|04/2021||||
2587104|NCT02322814|Secondary|Cohort III: AUC0-tau of Nab-Paclitaxel||Safety Run-In: Predose (Hr 0) on Cy1 D8; predose (Hr 0), 2, 4 Hr postdose (infusion duration: 30 minutes) on Cy1 D15 (Cy=28 days)||2021-04-30|04/2021||||
2587105|NCT02322814|Secondary|Cohort III: Cmin of Nab-Paclitaxel||Safety Run-In: Predose (Hr 0) on Cy1 D8; predose (Hr 0), 2, 4 Hr postdose (infusion duration: 30 minutes) on Cy1 D15 (Cy=28 days)||2021-04-30|04/2021||||
2587106|NCT02322814|Secondary|Cohort III: Cmax of Nab-Paclitaxel||Safety Run-In: Predose (Hr 0) on Cy1 D8; predose (Hr 0), 2, 4 Hr postdose (infusion duration: 30 minutes) on Cy1 D15 (Cy=28 days)||2021-04-30|04/2021||||
2587107|NCT02322814|Secondary|Cohort I, II: AUC0-tau of Paclitaxel||Safety Run-In: Predose (Hr 0) on Cy1 D8; predose (Hr 0), 0.5, 1, 2, 4, and 6 Hr postdose (2, 4 Hr postdose for Cohort II) (infusion duration: 1 Hr) on Cy1 D15 (Cy=28 days)||2021-04-30|04/2021||||
2587108|NCT02322814|Secondary|Cohort I, II: Cmin of Paclitaxel||Safety Run-In: Predose (Hr 0) on Cy1 D8; predose (Hr 0), 0.5, 1, 2, 4, and 6 Hr postdose (2, 4 Hr postdose for Cohort II) (infusion duration: 1 Hr) on Cy1 D15 (Cy=28 days)||2021-04-30|04/2021||||
2587109|NCT02322814|Secondary|Cohort I, II: Cmax of Paclitaxel||Safety Run-In: Predose (Hr 0) on Cy1 D8; predose (Hr 0), 0.5, 1, 2, 4, and 6 Hr postdose (2, 4 Hr postdose for Cohort II) (infusion duration: 1 Hr) on Cy1 D15 (Cy=28 days)||2021-04-30|04/2021||||
2587110|NCT02322814|Secondary|Cohort I, II, III: Area Under the Concentration-Time Curve From Time Zero to Dosing Interval (AUC0-tau; Total Exposure) of Cobimetinib||Safety Run-In: Predose (Hr 0) on Cy 1 D8; predose (Hr 0), 0.5, 1, 2, 4, 6 Hr postdose (2, 4 Hr postdose for Cohorts II, III) on Cy1 D15; Expansion: predose (Hr 0), 1-4 Hr postdose on Cy1 D15; predose (Hr 0) on Cy2 D15 (Cy=28 days)||2021-04-30|04/2021||||
2587111|NCT02322814|Secondary|Cohort I, II, III: Minimum Plasma Concentration (Cmin) of Cobimetinib||Safety Run-In: Predose (Hr 0) on Cy 1 D8; predose (Hr 0), 0.5, 1, 2, 4, 6 Hr postdose (2, 4 Hr postdose for Cohorts II, III) on Cy1 D15; Expansion: predose (Hr 0), 1-4 Hr postdose on Cy1 D15; predose (Hr 0) on Cy2 D15 (Cy=28 days)||2021-04-30|04/2021||||
2587112|NCT02322814|Secondary|Cohort I, II, III: Maximum Plasma Concentration (Cmax) of Cobimetinib||Safety Run-In: Predose (Hour [Hr] 0) on Cycle (Cy) 1 Day (D) 8; predose (Hr 0), 0.5, 1, 2, 4, 6 Hr postdose (2, 4 Hr postdose for Cohorts II, III) on Cy1 D15; Expansion: predose (Hr 0), 1-4 Hr postdose on Cy1 D15; predose (Hr 0) on Cy2 D15 (Cy=28 days)||2021-04-30|04/2021||||
2587113|NCT02322814|Secondary|Cohort I, II, III: Percentage of Participants With Adverse Events (AEs)||Randomization up to end of study (up to approximately 5.5 years)||2021-04-30|04/2021||||
2587114|NCT02322814|Secondary|Cohort II, III: Progression-Free Survival, as Determined by Investigator Using RECIST v1.1||Randomization up to disease progression or relapse, whichever occurs first (up to approximately 5.5 years)||2021-04-30|04/2021||||
2587115|NCT02322814|Secondary|Cohort I, II, III: Percentage of Participants With Unconfirmed Overall Response (OR_uc) (Unconfirmed PR or CR), as Determined by the Investigator Using RECIST v1.1||Randomization up to disease progression or relapse, whichever occurs fist (up to approximately 5.5 years)||2021-04-30|04/2021||||
2587120|NCT02322814|Primary|Cohort I: Progression-Free Survival, as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|PFS was defined as the time from randomization to the first occurrence of disease progression or relapse, as determined by the investigator, using RECIST v1.1.|Randomization up to disease progression or relapse, whichever occurs first (up to approximately 3.5 years)|ITT population|||Weeks||95% Confidence Interval|Median
2587121|NCT02322788|Primary|Provocative Concentration of Methacholine Which Produces a 20% Fall in FEV1 (PC20)||4 cross-over treatments (<1 day each) with 2-10 days between treatment washout periods|Efficacy analysis set|||mg/mL||95% Confidence Interval|Least Squares Mean
2587122|NCT02322775|Secondary|Peripheral Blood Eosinophil Levels|"Peripheral blood eosinophil levels assessments were collected from all patients at baseline prior to first benralizumab administration at Day 1, at the Week 12 visit or the IP discontinuation visit, and at the Week 20 follow-up visit.~Changes at Week 12 (respectively at Week 20) were calculated based on patients with both baseline and Week 12 (respectively Week 20)."|Baseline, Week 12 and Week 20|The safety analysis set comprised all patients who received at least one dose of IP. Patients were classified according to the treatment they actually received. A patient who has on one or several occasions received active treatment was classified as active.|||Cells/µL||Full Range|Median
2587123|NCT02322775|Secondary|Serum Concentrations (ng/mL)|Blood samples (processed to serum) for pharmacokinetic assessments were collected from all patients at baseline prior to first benralizumab administration at Day 1, at the Week 12 visit or the IP discontinuation visit, and at the Week 20 follow-up visit. Serum concentrations of benralizumab were determined using a validated electrochemiluminescent (ECL) immunoassay.|Baseline, Week 12 and Week 20|The pharmacokinetic (PK) analysis set comprised all patients who received benralizumab and from whom PK blood samples were obtained are assumed not to be affected by factors such as protocol violations. Those patients who had at least 1 quantifiable serum PK observation post first dose were included in the PK analysis dataset.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2587124|NCT02322775|Secondary|Change From Baseline in AQLQ(S)+12 Total and Domain Scores at Week 12|"The asthma quality of life questionnaire for 12 years and older, AQLQ(S)+12, consists of 32 questions; all assessed on a 7-point scale from 7 to 1, where 7 represents no impairment and 1 represents severe impairment. The 4 individual domain scores (symptoms, activity limitations, emotional function, and environmental stimuli) are the means of the responses to the questions in each of the domains. The overall score is calculated as the mean response to all questions. The changes from baseline of AQLQ(S)+12 score are compared between benralizumab 30 mg Q4W and placebo by using the analyse of covariance (ANCOVA) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL) and region (Europe or North America) as fixed effects and baseline AQLQ(S)+12 score as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.|||Scores on a scale||Standard Deviation|Mean
2587125|NCT02322775|Secondary|Asthma Exacerbations|An asthma exacerbation was defined as a worsening of asthma that led to use of systemic corticosteroids for at least 3 days (a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids) or an emergency room or urgent care visit (defined as evaluation and treatment for <24 hours in an emergency department or urgent care center) due to asthma that required systemic corticosteroids (as per above) or an inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma. Number of patients experiencing an event included in the definition of asthma exacerbation was presented.|Up to Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.|||Patients per number of exacerbations|||Number
2587126|NCT02322775|Secondary|Change From Baseline in Mean ACQ-6 Score at Week 12|"The asthma control questionnaire, ACQ-6, consists of six questions; all assessed on a 7-point scale from 0 to 6, where 0 represents good control and 6 represents poor control. The overall score is the mean of the responses to each of the six questions. The changes from baseline of ACQ-6 score are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit (Week 4, Week 8, Week 12), region (Europe or North America) and treatment*visit interaction as fixed effects and baseline ACQ-6 score as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 4, Week 8 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.|||Scores on a scale||Standard Deviation|Mean
2587127|NCT02322775|Secondary|Change From Baseline in Proportion of Nights With Nocturnal Awakenings at Week 12|"Nocturnal awakenings due to asthma symptoms and requiring rescue medication use was recorded by the patient in the asthma daily diary each morning. Proportion of nights with nocturnal awakenings was defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data for awakening due to asthma. The outcome variable for proportion of nights with nocturnal awakenings was the change from baseline at Week 12 in weekly proportion of nights with nocturnal awakenings. The changes are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline proportion of nights with nocturnal awakenings as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.|||Proportion of nights||Standard Deviation|Mean
2587269|NCT02320838|Secondary|Change Current Density (mA/cm2)|Change in current density (mA/cm2), it will be recorded at 1 min. start of the treatment session and at 20 min of the same.|at 1 min. treatment session, at 20 min. treatment session|"Sham stimulation arm was not included in the analysis of change current density because in the Sham group no current was applied."|||mA/cm2||Standard Deviation|Mean
2601700|NCT02150837|Secondary|Lean Mass|Lean mass expressed as an absolute change from baseline.|8 weeks||||Pounds||Standard Deviation|Mean
2587128|NCT02322775|Secondary|Change From Baseline in Total Asthma Rescue Medication Use (Puffs) at Week 12|"The number of rescue medication inhalations and nebulizer treatments taken were recorded by the patient in the asthma daily diary twice daily. The number of inhalations (puffs) per day was calculated as [number of night inhaler puffs] + 2 x [number of night nebulizer times] + number of day inhaler puffs + 2 x [number of day nebulizer times]. The changes from baseline in weekly total asthma rescue medication use (puffs) are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline total asthma rescue medication use (puffs) as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.|||Puffs per day||Standard Deviation|Mean
2587129|NCT02322775|Secondary|Change From Baseline in Total Asthma Symptom Score at Week 12|"Asthma symptoms were recorded by the patient each morning and evening in the asthma daily diary. Symptoms were recorded using a scale of 0-3, where 0 indicates no asthma symptoms. The daily asthma symptom total score was calculated by taking the sum of the daytime score recorded in the evening and the nighttime score recorded the following morning. The weekly total asthma score was averaged from the daily scores over a 7 day period, with score ranging from 0 to 6, where 0 indicates no asthma symptoms. The changes from baseline of weekly total asthma score are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline total asthma score as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.|||Scores on a scale||Standard Deviation|Mean
2587130|NCT02322775|Secondary|Change From Baseline in Evening Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12|"The changes from baseline of weekly average of evening PEF (L/min) are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model for repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline evening PEF (L/min) as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.|||L/min||Standard Deviation|Mean
2587131|NCT02322775|Secondary|Change From Baseline in Morning Peak Expiratory Flow (PEF) (L/Min) at Home at Week 12|"The changes from baseline of weekly average of morning PEF (L/min) are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect model for repeated measures (MMRM) with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit, region (Europe or North America) and treatment*visit interaction as fixed effects and baseline morning PEF (L/min) as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.|||L/min||Standard Deviation|Mean
2587132|NCT02322775|Primary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (L) at Week 12|"The FEV1 (L) change from baseline are compared between benralizumab 30 mg Q4W and placebo by using the mixed-effect repeated measures (MMRM) analysis with baseline blood eosinophil count (≥300 cells/μL or <300 cells/μL), protocol specified visit (Week 4, Week 8, Week 12), region (Europe or North America) and treatment*visit interaction as fixed effects and baseline pre-bronchodilator FEV1 (L) as a covariate.~Changes at Week 12 were calculated based on patients with both baseline and Week 12."|Baseline, Week 4, Week 8 and Week 12|The Full Analysis Set comprised all patients randomised and receiving any investigational product (IP), irrespective of their protocol adherence and continued participation in the study.|||Litre||Standard Deviation|Mean
2587133|NCT02322749|Secondary|The PK of N-desmethyl Selumetinib by Assessment of the AUC(0-t)|The PK of the metabolite N-desmethyl selumetinib was evaluated by assessing the AUC(0-t) of the metabolite in healthy volunteers after oral administration of single doses of the blue reference capsule (Treatment A), the free base variant capsule (Treatment B) and the TPGS variant capsule (Treatment C).|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2587134|NCT02322749|Secondary|The PK of the Metabolite N-desmethyl Selumetinib by Assessment of Cmax|The PK of the metabolite N-desmethyl selumetinib was evaluated by assessing the Cmax of the metabolite in healthy volunteers after oral administration of single doses of the blue reference capsule (Treatment A), the free base variant capsule (Treatment B) and the TPGS variant capsule (Treatment C).|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2587270|NCT02320838|Secondary|Perception Current Comfortability|Participants will choose the current treatment that has found more comfortable|At the end of the third experimental session, 3 days|"Sham stimulation arm was not included in the analysis of perception current comfortability because in the Sham group no current was applied."|||Participants|||Count of Participants
2587135|NCT02322749|Secondary|Relative Bioavailability of the TPGS Capsule Variant (Treatment C) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC(0-t)]|The relative bioavailability of the TPGS capsule variant of selumetinib (Treatment C) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the AUC[0-t] of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2587136|NCT02322749|Secondary|Relative Bioavailability of the TPGS Capsule Variant (Treatment C) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC]|The relative bioavailability of the TPGS capsules variant of selumetinib (Treatment C) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the AUC of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2587137|NCT02322749|Secondary|Relative Bioavailability of the TPGS Capsule Variant (Treatment C) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib Cmax]|The relative bioavailability of the TPGS capsule variant of selumetinib (Treatment C) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the Cmax of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2587138|NCT02322749|Primary|Bioequivalence of the Free Base Variant of Selumetinib (Treatment B) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC(0-t)]|The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2587139|NCT02322749|Primary|Bioequivalence of the Free Base Variant of Selumetinib (Treatment B) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib AUC]|The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post dose for each of the separate treatment periods (Visits 2, 3 and 4).|The PK analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.|||ng * hour per mL (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2587140|NCT02322749|Primary|Bioequivalence of the Free Base Variant of Selumetinib (Treatment B) Compared to the Blue Reference Capsule (Treatment A) [Selumetinib Cmax]|The bioequivalence of the free base variant of selumetinib (Treatment B) as compared to the blue reference capsule (Treatment A) was evaluated by comparing the maximum observed plasma concentration (Cmax) of selumetinib in healthy volunteers.|Blood samples were collected pre-dose, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 36 and 48 hours post dose for each of the separate treatment periods (Visits 2, 3 and 4).|The Pharmacokinetic (PK) analysis set included all healthy subjects who received at least 1 dose of selumetinib and had at least 1 post-dose PK measurement without important protocol deviations/violations or events significantly affecting the PK.|||nanograms per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2587141|NCT02322710|Primary|Percentage of Patients With Complete Healing (100% of Epithelialization).|Using photographs,independent assessor blinded assessment.|Day 21|Per protocol population|||Participants|||Count of Participants
2587142|NCT02322528|Primary|Visual Quality|Using a Shack Hartmann wavefront sensor, measured root mean square of wavefront aberrations caused by dynamic tear film changes.|baseline, 30 minutes, week 1, week 2||||microns||Standard Deviation|Mean
2587143|NCT02322528|Primary|Ocular Surface Temperature of Both Eyes|Lotemax® is an FDA-approved ophthalmic suspension for the treatment of steroid-responsive inflammatory conditions which include dry eye associated ocular surface inflammation. Lotemax® will serve as a vehicle to study the changes in the inflammatory mediators on the surface of the eye as well as collect the inflammatory mediators for laboratory analysis, utilizing Luminex instrumentation and standard ELISA assays.|baseline, 30 minutes, week 1, week 2||||degrees celcius||Standard Deviation|Mean
2587144|NCT02322411|Secondary|Hospital Admissions (Number of Hospital Admissions and Readmissions)|The number of hospital admissions and readmissions within 9 months following completion of the program will be compared to the same pre-enrollment period.|up to 9 months||||hospital admissions|||Number
2587145|NCT02322411|Secondary|Pneumonia Diagnoses (Number of Pneumonia Diagnoses)|The number of pneumonia diagnoses within 9 months following completion of the program will be compared to the same pre-enrollment period.|up to 9 months||||incidences of pneumonia|||Number
2587271|NCT02320838|Secondary|Habituation to Electrical Stimulation|The habituation to electrical stimulation along experimental session will be measured by recording the difference on current intensity (mA) at the start of the treatment session (1 min) and end of the same (20 min)|Start treatment session (1 min), end treatment session (20 min)|"Sham stimulation arm was not included in the analysis because for the habituation to the current the increased intensity was measured throughout the session and in the Sham group no current was applied"|||mA||Standard Deviation|Mean
2587146|NCT02322411|Secondary|Functional Oral Intake Scale (FOIS) Scores|FOIS scores reflect level of nutritional intake. Scores range from 1 to 7, with 1 being nothing by mouth and with 7 indicating a diet with no restrictions. Qualitative assessment via interview. Range of final scores is between 1 and 7. Average scores of each arm reported at 8 and 12 weeks.|After 8 weeks and 12 weeks|FOIS score at 8 weeks - 9 subjects for I-PRO group FOIS score at 8 weeks - 10 subjects for compensatory group FOIS score at 12 weeks - 8 subjects for I-PRO group FOIS score at 12 weeks - 6 subjects for compensatory group|||score on a scale||Standard Deviation|Mean
2587147|NCT02322411|Secondary|Dysphagia-related Quality of Life Scores (SWAL-QOL)|A quality of life questionnaire related to swallowing. The scores range from 0-100, and a higher score indicates a higher quality of life related to swallowing.|After 8 weeks and 12 weeks|SWAL-QOL score at 8 weeks - 9 subjects for I-PRO group SWAL-QOL score at 12 weeks - 6 subjects for I-PRO group SWAL-QOL score at 8 weeks - 7 subjects for compensatory group SWAL-QOL score at 12 weeks - 7 subjects for compensatory group|||score on a scale||Standard Deviation|Mean
2587148|NCT02322411|Secondary|Swallowing-related Pressures (Videofluoroscopic Swallow Study)|Pressures will be measured while the subject is swallowing during the videofluoroscopic swallow study|After 8 and 12 weeks|Data for this secondary outcome measure was not collected as the equipment stopped working at the start of the study. The study team did not have the resources to purchase new equipment to collect these data.||||||
2587149|NCT02322411|Secondary|Bolus Flow Durational Measures (Taken From Videofluoroscopic Recordings)|Measurements of bolus flow taken from videofluoroscopic recordings|After 8 and 12 weeks||2020-05-31|05/2020||||
2587150|NCT02322411|Primary|Lingual Pressures (Changes in the One Repetition Maximum Isometric Lingual Pressures)|Changes in the one repetition maximum isometric lingual pressures measured at the front and back sensors of the device|After 8 weeks and 12 weeks|Front/Back Lingual Pressure at 8 weeks and 12 weeks - 6 subjects for Compensatory group Front/Back Lingual Pressure at 8 weeks - 8 subjects for I-PRO group Front/Back Lingual Pressure at 12 weeks - 6 subjects for I-PRO group|||hPa||Standard Deviation|Mean
2587151|NCT02322281|Secondary|Plasma PK for Patients Treated With Rociletinib Based on Sparse Sampling|Blood samples were drawn for PK analysis at 21 ± 3 day intervals for the first 6 months (Day 1 of Cycles 2 to 7 inclusive). The sample could be taken predose or postdose. Plasma concentrations are presented for Rociletinib and 3 metabolites (M460, M502, M544).|Cycles 2 Day 1 to Cycle 7 Day 1, or approximately 6 months|A small subset of patients treated with rociletinib (ie, patients randomized to receive rociletinib or who crossed over to receive rociletinib following treatment with single agent cytotoxic chemotherapy). Note: 2 patients in the 625mg treatment group had M502 values at upper limit of quantification (ULOQ) which were set as missing values.|||Plasma concentration (ng/mL)|Plasma samples|Full Range|Median
2587152|NCT02322281|Secondary|Overall Survival (OS)|OS was calculated as 1+ the number of days from randomization to death due to any cause. Patients without a documented date of death were censored on the date the patient was last known to be alive.|Cycle 1 Day 1 to date of death, assessed up to 3 years|Intent-to-treat: All patients randomized.1 patient in the Roci 500 and 2 patients in the Chemo treatment group were not included in the analysis because their OS data was not collected. 1 additional patient in the Chemo group was not included due to discontinuation from study shortly after randomization and prior to first dose of study drug.|||Days||95% Confidence Interval|Median
2587153|NCT02322281|Secondary|Duration of Response (DOR) According to RECIST Version 1.1 as Determined by Investigator Assessment|DOR in patients with confirmed response per investigator. The DOR for complete response (CR) and partial response (PR) was measured from date that any of these best responses is first recorded until first date that progressive disease (PD) is objectively documented. For patients who continue treatment post-progression, the first date of progression was used for the analysis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. PR is at least a 30% decrease in sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Overall Response is the best response from start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).|Cycle 1 Day 1 to End of Treatment, up to approximately 35 months|"The DOR was measured only in those patients with a confirmed Complete Response (CR) or Partial Response (PR). The overall number of participants analyzed in the Chemotherapy arm includes only participants treated with chemotherapy and not patients who crossed over into the rociletinib treatment groups."|||Days||95% Confidence Interval|Median
2587154|NCT02322281|Secondary|Percentage of Participants With Confirmed Response|Percentage of patients with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression or recurrence. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR),at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Overall Response (OR),is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment was dependent on the achievement of both measurement and confirmation criteria.|Cycle 1 Day 1 to End of Treatment, up to approximately 35 months. This Time Frame includes the cross-over period, however, participants who crossed over to rociletinib were not analyzed for best overall confirmed response.|Intent-to-treat: All patients randomized. 1 patient in the Chemotherapy treatment group was not included in the analysis, due to discontinuation of study shortly after randomization and prior to first dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2587177|NCT02321800|Secondary|Percentage of Participants With Clinical Response at Early Assessment Per Uropathogen|Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms, with response defined as resolution or improvement of complicated urinary tract infection symptoms present at study entry and the absence of new symptoms. Results are reported for the 4 most frequent uropathogens, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Proteus mirabilis.|Early assessment, Day 4|Modified intent-to-treat population with the relevant pathogen at Baseline and with available clinical outcome data|||percentage of participants|||Number
2587155|NCT02322281|Primary|Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)|PFS was calculated as 1+ the number of days from the date of randomization to documented radiographic progression as determined by the investigator, or death due to any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression.|Cycle 1 Day 1 to End of Treatment, up to approximately 35 months. This Time Frame includes the cross-over period, however, participants who crossed over to rociletinib were not analyzed for PFS.|Intent-to-treat: All patients randomized. 1 patient in the Chemotherapy treatment group was not included in the analysis, due to discontinuation of study shortly after randomization and prior to first dose of study drug.|||Days||95% Confidence Interval|Median
2587156|NCT02322229|Secondary|Change From Baseline in Central Foveal Thickness at Days 28 and 180|Central foveal thickness (CFT) was determined by subtracting the measurements in subretinal fluid (SRF) and retinal pigment epithelium (RPE) elevation and/or subretinal hyper-reflective material (SHRM) from the value in total retinal measurement. The change was defined as a change from baseline values of CFT. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 28, Day 180|Missing data is imputed using the LOCF method. CFT values after a vitrectomy are imputed with the last non-missing value prior to the vitrectomy.|||Microns||Standard Deviation|Mean
2587157|NCT02322229|Secondary|Percentage of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180|Pars plana vitrectomy (the surgical removal of vitreous gel from the eye) was captured in Concomitant Ocular Procedures. One eye (study eye) contributed to the analysis.|Day 180|Full Analysis Set|||percentage of subjects|||Number
2587158|NCT02322229|Secondary|Percentage of Subjects With Non-surgical Resolution of VMT/sVMA at Days 7, 90, and 180|As described in Primary Outcome Measure|Baseline (Day 0), Day 7, Day 90, Day 180|Full Analysis Set. Missing data imputed for Days 90 and 180 using the LOCF method. Subjects who had vitrectomy are considered as 'no VMA resolution' after the timepoint of vitrectomy.|||percentage of subjects|||Number
2587159|NCT02322229|Secondary|Percentage of Subjects With Closure of Macular Hole (MH), at Days 7, 28, 90, and 180 (if Present at Baseline)|The closure of macular hole (a full thickness defect of the retinal tissue involving the anatomical fovea) is defined as a flattened and reattached hole rim along the whole circumference of macular hole. Closure was determined by SD-OCT evaluation and the percentage of subjects tabulated. One eye (study eye) contributed to the analysis.|Day 7, Day 28, Day 90, Day 180|This analysis population includes all subjects in Full Analysis Set with MH at baseline (n=4). Subjects who had vitrectomy after MH closure are considered as 'no MH closure' after the timepoint of vitrectomy.|||percentage of subjects|||Number
2587160|NCT02322229|Secondary|Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance at Days 7, 28, 90, and 180|BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing. BCVA was determined as follows: if tested at 4 meters, BCVA=the number of letters read correctly at 4 meters+30; if tested at 1 meter, BCVA=the number of letters read correctly at 1 meter, with 83-84 representing normal vision. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 7, Day 28, Day 90, Day 180|Full Analysis Set. Missing data imputed using the LOCF method. BCVA values after a vitrectomy are imputed with the last non-missing value prior to the vitrectomy.|||letters||Standard Deviation|Mean
2587161|NCT02322229|Primary|Percentage of Subjects With Non-surgical Resolution of Focal VMT/sVMA at Day 28, as Determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD‐OCT) Evaluation|Vitreous separation was assessed, by SD-OCT according to CRC OCT image reading, into 1 of 12 categories, where the targeted status of VMA resolution was 7=Vitreous attached only at optic nerve (ON) or at ON and elsewhere, but not attached in macular, 9=Vitreous visible with complete separation and no attachment, and 10=No visible vitreous separation, which needed to be reached without prior vitrectomy. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. One eye (study eye) contributed to the analysis.|Day 28|Full Analysis Set. Missing data imputed using the last observation carried forward (LOCF) method. Subjects who had vitrectomy after VMA resolution are considered as 'no VMA resolution' after timepoint of vitrectomy.|||percentage of subjects|||Number
2587162|NCT02322216|Primary|Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14|Severity of ocular itching was evaluated as the worst score observed in the past 24 hours prior to each study visit. Ocular itching was assessed by the participant on a scale from 0-4, where 0=None and 4=Incapacitating itch. One eye (study eye) contributed to the analysis.|Baseline, Day 14|Per Protocol Set with non-missing data|||units on a scale||Standard Error|Mean
2587163|NCT02322190|Secondary|Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 8 months and 6 days||||Participants|||Count of Participants
2587164|NCT02322190|Secondary|Days to Overall Survival|Overall survival is defined as the time from study entry to end of observations/off study.|time from study entry to end of observations/off study, up to a year||||Days||Full Range|Median
2587207|NCT02321748|Primary|Apparent Volume of Distribution (Vd/f) of Montelukast||Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention||||L||Standard Deviation|Mean
2587208|NCT02321748|Primary|Half-Life (t1/2) of Montelukast||Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention||||h||Geometric Coefficient of Variation|Geometric Mean
2587165|NCT02322190|Primary|Number of Participants With Steroid Refractory Disease Who Had Improvement and/or Resolution of Graft-versus-host Disease (GVHD) Associated Symptoms|GVHD associated symptoms was assessed by the American Society for Bone Marrow Transplantation consensus statement. Complete Response (CR) is no residual organ specific symptoms or findings. Very Good Partial Response (VGPR) is Skin: An active erythematous rash involving < 25% of the body surface area; Liver: Persistent low-level hyperbilirubinemia, and/or Gut: Gastrointestinal function and water resorption in the colon are approaching normal. Partial Response (PR) is any improvement over baseline symptoms. Progressive disease (PD) is stable or worsening organ specific findings requiring change of therapy.|7 months||||Participants|||Count of Participants
2587166|NCT02322190|Primary|Number of Participants With Biomarkers (Serum TIM3, IL-6, Reg-3-a, ST2, LPS-BP, Nitrate, TNFR1, IL-2Ra, CXCL10, and HGF) Present in Blood and/or Tissue Who Were Steroid Refractory After ECP Treatment|In an effort to determine steroid refractoriness after Extracorporeal Photopheresis (ECP) treatment, tissue and blood obtained from participants was examined to see if biomarkers (i.e., Serum T cell immunoglobulin and mucin domain-containing protein 3 (TIM3), ST2, Nitrate, Interleukin-6 (IL-6), regenerating family member 3 alpha (Reg-3-a), lipopolysaccharide binging protein (LPS-BP), tumor necrosis factor receptor 1 (TNFR1), interleukin-2 receptor alpha chain (IL-2Ra), CXC motif chemokine 10 (CXCL10), hepatocyte growth factor (HGF)) were present.|14 Days|No data was collected for this outcome measure and it not done because biomarker studies require large patient numbers to analyze data. Only five participants were enrolled in this study. With early termination, there are no biomarker data to report.||||||
2587167|NCT02321930|Secondary|MBDA|The multi-biomarker disease activity (MBDA) blood test assesses RA disease activity. An algorithm of 12 markers is used to characterize RA disease activity on a scale of 1-100, where a score of 100 represents the highest level of disease activity present.|Baseline, Week 2, Month 3||||units on a scale||Standard Deviation|Mean
2587168|NCT02321930|Primary|DAS28/ESR|TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. Patient Global Assessment of disease activity was scored 0-100 millimeters (mm) and rounded to the nearest centimeter (cm) on a visual analog scale (VAS), where higher scores indicate greater perceived disease activity. ESR lab value were included in the total calculation. The scale being used is called the Disease Activity Score for 28 Joints (DAS28) using the Erythrocyte Sedimentation Rate (ESR) in the calculation.The scale ranges from 0 to 9.4, where higher values represent a higher disease activity.The complete formula to calculate DAS28/ESR is 0.56*sqrt(TJC) + (0.28*sqrt(SJC)) + (0.7*ln(ESR)) + (0.014*Patient Global*10).|Baseline, Week 2, Month 3||||units on a scale||Standard Deviation|Mean
2587169|NCT02321930|Primary|CDAI|CDAI was derived as the sum of the following: tender joint count (TJC), swollen joint count (SJC), participant global assessment (PGA) of disease activity, and physician assessment of disease activity. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 millimeters (mm) and rounded to the nearest centimeter (cm) on a visual analog scale (VAS), where higher scores indicate greater perceived disease activity. The total CDAI score range was 0-76, where higher scores indicate increased disease activity.|Baseline, Week 2, Month 3||||units on a scale||Standard Deviation|Mean
2587170|NCT02321930|Primary|GSUS|30 joints will be evaluated using a 0 to 3 point scale for each joint and the sum of these represents GSUS. The grey scale synovial hypertrophy score (GSUS) ranges from 0 to 90. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. A higher value of the total score for GSUS represents more severe disease level.|Baseline, Week 2, Month 3||||units on a scale||Standard Deviation|Mean
2587171|NCT02321930|Primary|PDUS|30 joints will be evaluated using a 0 to 3 point scale for each joint and the sum of these represents PDUS. The Power Doppler Synovitis Score (PDUS) ranges from 0 to 90. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. A higher value of the total score for PDUS represents more severe disease level.|Baseline, Week 2, Month 3||||units on a scale||Standard Deviation|Mean
2587172|NCT02321800|Secondary|Number of Participants With Adverse Events|"A serious adverse event was defined by regulation as any adverse event (AE) occurring at any dose that resulted in any of the following outcomes:~Death~Life-threatening condition~Hospitalization or prolongation of existing hospitalization~Persistent or significant disability/incapacity~Congenital anomaly/birth defect~Other medically important condition.~The relationship of an event to the study drug was determined by the investigator based on whether the AE could be reasonably explained as being caused by the study drug."|From first dose of study drug until 28 days after end of treatment; Day 35 to 42|The safety population included all randomized participants who received at least 1 dose of the study drug|||Participants|||Count of Participants
2587173|NCT02321800|Secondary|Urine Concentration of Cefiderocol||Day 3, 2 hours and 6 hours after end of infusion|Pharmacokinetic concentration population with available urine concentration data|||µg/mL||Standard Deviation|Mean
2587174|NCT02321800|Secondary|Plasma Concentration of Cefiderocol||On Day 3 of dosing prior to infusion, end of infusion, and at 1 hour post infusion|The pharmacokinetic (PK) concentration population included all participants who underwent plasma or urine PK sampling and had at least 1 evaluable PK assay result for cefiderocol|||µg/mL||Standard Deviation|Mean
2587175|NCT02321800|Secondary|Percentage of Participants With Clinical Response at Follow-up Per Uropathogen|Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms, with sustained response defined as all pre-therapy signs and symptoms of cUTI show no evidence of recurrence after administration of the last dose of study drug. Results are reported for the 4 most frequent uropathogens, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Proteus mirabilis.|Follow-up, 14 days after the end of treatment, Day 21 to 28|Modified intent-to-treat population with the relevant pathogen at Baseline and with available clinical outcome data|||percentage of participants|||Number
2587176|NCT02321800|Secondary|Percentage of Participants With Clinical Response at End of Treatment Per Uropathogen|Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms, with response defined as resolution or improvement of complicated urinary tract infection symptoms present at study entry and the absence of new symptoms. Results are reported for the 4 most frequent uropathogens, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Proteus mirabilis.|End of treatment, Day 7 to 14|Modified intent-to-treat population with the relevant pathogen at Baseline and with available clinical outcome data|||percentage of participants|||Number
2587178|NCT02321800|Secondary|Percentage of Participants With Clinical Response at Test of Cure Per Uropathogen|Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms, with response defined as resolution or improvement of complicated urinary tract infection symptoms present at study entry and the absence of new symptoms. Results are reported for the 4 most frequent uropathogens, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Proteus mirabilis.|Test of cure, 7 days after end of treatment, Day 14 to 21|Modified intent-to-treat population with the relevant pathogen at Baseline and available clinical outcome data|||percentage of participants|||Number
2587179|NCT02321800|Secondary|Percentage of Participants With Clinical Response at Follow-up|Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms, with sustained response defined as all pre-therapy signs and symptoms of cUTI showing no evidence of recurrence after administration of the last dose of study drug.|Follow-up, 14 days after end of treatment, Day 21 to 28|Modified intent-to-treat population|||percentage of participants|||Number
2587180|NCT02321800|Secondary|Percentage of Participants With Clinical Response at End of Treatment|Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms, with response defined as resolution or improvement of complicated urinary tract infection symptoms present at study entry and the absence of new symptoms.|End of treatment, Day 7 to 14|Modified intent-to-treat population|||percentage of participants|||Number
2587181|NCT02321800|Secondary|Percentage of Participants With Clinical Response at Early Assessment|Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms, with response defined as resolution or improvement of complicated urinary tract infection symptoms present at study entry and the absence of new symptoms.|Early assessment, Day 4|Modified intent-to-treat population|||percentage of participants|||Number
2587182|NCT02321800|Secondary|Percentage of Participants With Clinical Response at Test of Cure|Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms, with response defined as resolution or improvement of complicated urinary tract infection symptoms present at study entry and the absence of new symptoms.|Test of cure, 7 days after end of treatment, Day 14 to 21|Modified intent-to-treat population|||percentage of participants|||Number
2587183|NCT02321800|Secondary|Percentage of Participants With Microbiological Eradication at Follow-up Per Uropathogen|"Microbiological outcome was based on quantitative microbiological urine cultures, with sustained eradication defined as a urine culture obtained after documented eradication at the TOC, up to and including the FUP, where the bacterial uropathogen identified at baseline at ≥ 10⁵ CFU/mL remained < 10⁴ CFU/mL.~Results are reported for the 4 most frequent uropathogens, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Proteus mirabilis."|Follow-up, 14 days after the end of treatment, Day 21 to 28|Modified intent-to-treat population with the relevant pathogen at Baseline|||percentage of participants|||Number
2587184|NCT02321800|Secondary|Percentage of Participants With Microbiological Eradication at End of Treatment Per Uropathogen|"Microbiological outcome was based on quantitative microbiological urine cultures, with eradication defined as the bacterial pathogen found at study entry at > 1 × 10⁵ CFU/mL reduced to 1 × 10⁴ CFU/mL or less.~Results are reported for the 4 most frequent uropathogens, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Proteus mirabilis."|End of treatment, Day 7 to 14|Modified intent-to-treat population with the relevant pathogen at Baseline|||percentage of participants|||Number
2587185|NCT02321800|Secondary|Percentage of Participants With Microbiological Eradication at Early Assessment Per Uropathogen|"Microbiological outcome was based on quantitative microbiological urine cultures, with eradication defined as the bacterial pathogen found at study entry at > 1 × 10⁵ CFU/mL reduced to 1 × 10⁴ CFU/mL or less.~Results are reported for the 4 most frequent uropathogens, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Proteus mirabilis."|Early assessment, Day 4|Intent-to-treat population with the relevant pathogen at Baseline|||percentage of participants|||Number
2587186|NCT02321800|Secondary|Percentage of Participants With Microbiological Eradication at Test of Cure Per Uropathogen|"Microbiological outcome was based on quantitative microbiological urine cultures, with eradication defined as the bacterial pathogen found at study entry at > 1 × 10⁵ CFU/mL reduced to 1 × 10⁴ CFU/mL or less.~Results are reported for the 4 most frequent uropathogens, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Proteus mirabilis."|Test of cure; 7 days after end of treatment, Day 14 to 21|Modified intent-to-treat population with the relevant pathogen at Baseline|||percentage of participants|||Number
2587187|NCT02321800|Secondary|Percentage of Participants With Microbiological Eradication at Follow-up|Microbiological outcome was based on quantitative microbiological urine cultures, with sustained eradication defined as a urine culture obtained after documented eradication at the TOC, up to and including the FUP, where the bacterial uropathogen(s) identified at baseline at ≥ 10⁵ CFU/mL remained < 10⁴ CFU/mL.|Follow-up, 14 days after end of treatment, Day 21 to 28|Modified intent-to-treat population|||percentage of participants|||Number
2587188|NCT02321800|Secondary|Percentage of Participants With Microbiological Eradication at End of Treatment|Microbiological outcome was based on quantitative microbiological urine cultures, with eradication defined as all bacterial uropathogens found at study entry at > 1 × 10⁵ CFU/mL reduced to 1 × 10⁴ CFU/mL or less.|End of treatment, Day 7 to 14|Modified intent-to-treat population|||percentage of participants|||Number
2587189|NCT02321800|Secondary|Percentage of Participants With Microbiological Eradication at Early Assessment|Microbiological outcome was based on quantitative microbiological urine cultures, with eradication defined as all bacterial uropathogens found at study entry at > 1 × 10⁵ CFU/mL reduced to 1 × 10⁴ CFU/mL or less.|Early assessment, Day 4|Modified intent-to-treat population|||percentage of participants|||Number
2587190|NCT02321800|Secondary|Percentage of Participants With Microbiological Eradication at Test of Cure|Microbiological outcome was based on quantitative microbiological urine cultures, with eradication defined as all bacterial uropathogens found at study entry at > 1 × 10⁵ CFU/mL reduced to 1 × 10⁴ CFU/mL or less.|Test of cure (7 days after end of treatment, Day 14 to 21)|Modified intent-to-treat population|||percentage of participants|||Number
2587209|NCT02321748|Primary|Area Under the Curve (AUC) of Montelukast||Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2587191|NCT02321800|Secondary|Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Follow-up|"A composite response of clinical response and microbiological response at the follow-up assessment, defined as 14 days after the end of treatment.~Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms, with sustained response defined as all pre-therapy signs and symptoms of cUTI show no evidence of recurrence after administration of the last dose of study drug.~Microbiological outcome was based on quantitative microbiological urine cultures, with sustained eradication defined as a urine culture obtained after documented eradication at the TOC, up to and including the FUP, showed that the bacterial uropathogen(s) identified at baseline at ≥ 10⁵ CFU/mL remained < 10⁴ CFU/mL."|Follow-up (FUP; 14 days after end of treatment, Day 21 to 28)|Modified intent-to-treat population|||percentage of participants|||Number
2587192|NCT02321800|Secondary|Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at End of Treatment|"A composite outcome of clinical response and microbiological response at the end of treatment, defined as the end of the last infusion of antibiotic treatment.~Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms, with response defined as resolution or improvement of complicated urinary tract infection symptoms present at study entry and the absence of new symptoms.~Microbiological outcome was based on quantitative microbiological urine cultures, with eradication defined as the bacterial pathogen found at study entry at > 1 × 10⁵ CFU/mL reduced to 1 × 10⁴ CFU/mL or less."|End of treatment (EOT; Day 7 to 14)|Modified intent-to-treat population|||percentage of participants|||Number
2587193|NCT02321800|Secondary|Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Early Assessment|"A composite outcome of clinical response and microbiological response at the early assessment, defined as Day 4 of antibiotic treatment.~Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms, with response defined as resolution or improvement of complicated urinary tract infection symptoms present at study entry and the absence of new symptoms.~Microbiological outcome was based on quantitative microbiological urine cultures, with eradication defined as the bacterial pathogen found at study entry at > 1 × 10⁵ CFU/mL reduced to 1 × 10⁴ CFU/mL or less."|Early assessment (EA; Day 4)|Modified intent-to-treat population|||percentage of participants|||Number
2587194|NCT02321800|Primary|Percentage of Participants With Composite Response of Microbiological Eradication and Clinical Response at Test of Cure|"The primary efficacy endpoint was the composite outcome of clinical response and microbiological response at the test of cure assessment, defined as 7 days (±2 days) after the end of antibiotic treatment.~Clinical response was based on the investigator's evaluation of the participant's clinical signs and symptoms, with response defined as resolution or improvement of complicated urinary tract infection symptoms present at study entry and the absence of new symptoms.~Microbiological outcome was based on quantitative microbiological urine cultures, with eradication defined as the bacterial pathogen found at study entry at > 1 × 10⁵ CFU/mL reduced to 1 × 10⁴ CFU/mL or less."|Test of cure (TOC; 7 days after end of treatment [EOT], equivalent to Study Day 14 to 21)|Modified intent-to-treat population|||percentage of participants|||Number
2587195|NCT02321748|Other Pre-specified|Apparent Total Body Clearance (CL/f) of ASP2151||Blood samples were taken at pre-dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24h after post doses in first or second intervention||||L/h||Standard Deviation|Mean
2587196|NCT02321748|Other Pre-specified|Apparent Volume of Distribution (Vd/f) of ASP2151||Blood samples were taken at pre-dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24h after post doses in first or second intervention||||L||Standard Deviation|Mean
2587197|NCT02321748|Other Pre-specified|Half-Life (t1/2) of ASP2151||Blood samples were taken at pre-dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24h after post doses in first or second intervention||||h||Geometric Coefficient of Variation|Geometric Mean
2587198|NCT02321748|Other Pre-specified|Area Under the Curve (AUC) of ASP2151||Blood samples were taken at pre-dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24h after post doses in first or second intervention||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2587199|NCT02321748|Other Pre-specified|Time of Peak Concentration (Tmax) of ASP2151||Blood samples were taken at pre-dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24h after post doses in first or second intervention||||h||Full Range|Median
2587200|NCT02321748|Other Pre-specified|Peak Plasma Concentration (Cmax) of ASP2151||Blood samples were taken at pre-dose of Day 1 and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24h after post doses in first or second intervention||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2587201|NCT02321748|Other Pre-specified|Half-Life (t1/2) of Methyl Hydroxymontelukast||Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention||||h||Geometric Coefficient of Variation|Geometric Mean
2587202|NCT02321748|Other Pre-specified|Area Under the Curve (AUC) of Methyl Hydroxymontelukast||Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2587203|NCT02321748|Other Pre-specified|Time of Peak Concentration (Tmax) of Methyl Hydroxymontelukast||Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention||||h||Full Range|Median
2587204|NCT02321748|Other Pre-specified|Peak Plasma Concentration (Cmax) of Methyl Hydroxymontelukast||Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2587205|NCT02321748|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Refer to the result of adverse event.|Up to 32 days after the last dose||||participants|||Number
2587206|NCT02321748|Primary|Apparent Total Body Clearance (CL/f) of Montelukast||Blood samples were taken at pre-dose of Day 1 and 0.5, 1,1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 48 and 72h after post doses in first or second intervention||||L/h||Standard Deviation|Mean
2587272|NCT02320838|Primary|Tactile Threshold During Treatment|The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton|during treatment at 15 min.||||mN||Standard Deviation|Mean
2587212|NCT02321527|Primary|Number of Breast Cancer Participants With Sentinel Lymph Nodes (SLN) Identification Using the CEUS Technique|Following the Microbubble CEUS of ipsilateral axillary nodes, needle biopsy and I-125 seed placement, a single node/participant (biopsied node) will be included in the statistical evaluation. The technique determined as technically feasible if an enhancing node is visualized in at least 90% of the subjects and 80% concordance is achieved between imaging-guided biopsy and final surgical histopathology. If no enhancement is identified, the overlying skin will be massaged, and re-injection of contrast will be employed up to three times. If no contrast enhancement in lymphatics is observed, the case will be reported as a failure of the CEUS technique.|1 day||||Participants|||Count of Participants
2587213|NCT02321462|Secondary|Evaluation of Patient Compliance as Determined by the Percentage of Patients Who Consumed All the Planned Volume of Study Treatment|"Patient compliance was evaluated based on the percentage of patients who consumed all the planned volume of the study treatment.~A patient was considered compliant with the instructions of use provided in the prescription if he/she drank the whole preparation and any required further fluid intake. The percentage of compliant patients is presented."|Study treatment was administered as a split-dose on Days 1 and 2.|The ITT population consisted of all randomised patients who received even a partial dose of study treatment. Patients were assessed according to the randomised treatment, regardless of treatment received.|||percentage of participants|||Number
2587214|NCT02321462|Secondary|Investigator Satisfaction as Determined by Mean Likert Scale Score for Global Evaluation|"Investigator satisfaction with the procedure was measured by the mean Likert scale score for global evaluation by the investigator.~The Likert scale consists of 5 points, and ranges from 0 (poor cleansing) to 4 (excellent cleansing) as follows:~presence of faeces and soiled fluid: investigation could not be reliably performed = 0~presence of faecal material and of unclear fluid, with negative effect on the reliability of the investigation = 1~brown liquid, no solid faecal material, presence of unclear residual fluid that could be aspirated: no effect on the reliability of the investigation = 2~absence of solid faecal material, presence of clear residual fluid = 3~no faecal material, no residual fluid, empty colon = 4."|Colonoscopy was performed on Day 2.|The ITT population consisted of all randomised patients who received even a partial dose of study treatment. Patients were assessed according to the randomised treatment, regardless of treatment received. Only patients with data available are included.|||units on a scale||Standard Deviation|Mean
2587215|NCT02321462|Secondary|Mean Colonoscopy Duration|The mean colonoscopy duration per treatment group is presented. The duration of colonoscopy was defined as the time from colonoscopy insertion to the time to reach the caecum in minutes.|Colonoscopy was performed on Day 2.|The ITT population consisted of all randomised patients who received even a partial dose of study treatment. Patients were assessed according to the randomised treatment, regardless of treatment received. Only patients with data available are included.|||minutes||Standard Deviation|Mean
2587216|NCT02321462|Secondary|The Percentage of Patients for Whom the Colonoscopy Was Completed|The percentage of patients for whom a total colonoscopy could be completed is presented.|Colonoscopy was performed on Day 2.|The ITT population consisted of all randomised patients who received even a partial dose of study treatment. Patients were assessed according to the randomised treatment, regardless of treatment received.|||percentage of participants|||Number
2587217|NCT02321462|Secondary|The Percentage of Patients in Whom Lesions Were Detected.|The percentage of patients for whom polyps, adenomas and other lesions were detected during the colonoscopy are presented.|Colonoscopy was performed on Day 2.|The ITT population consisted of all randomised patients who received even a partial dose of study treatment. Patients were assessed according to the randomised treatment, regardless of treatment received. Percentages are calculated based on the overall ITT population.|||percentage of participants|||Number
2587218|NCT02321462|Secondary|Mean BBPS Score for Right Colon and Transverse Colon Segment (PP Population)|"The mean colon segment BBPS scores for the Right Colon and Transverse Colon segments for the PP population are presented.~For each of the colon segments (right and transverse colon) the BBPS score ranges from 0 - 3 (worst to best), and was assessed by 3 blinded experts as follows:~unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared = 0~portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid = 1~minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well = 2~entire mucosa of colon segment seen well with no residual staining, small fragments of stool and/or opaque liquid = 3.~Reconciled scores were based on the 3 blinded reviews."|Colonoscopy was performed on Day 2.|The PP population consisted of all randomised patients who received the preparation of study treatment (whether complete or partial), who underwent the colonoscopy procedure and for whom no protocol violation occurred until colonoscopy. Patients were assessed according to the randomised treatment, regardless of treatment received.|||units on a scale||Standard Deviation|Mean
2587219|NCT02321462|Secondary|Mean BBPS Score by Segment and Globally (ITT Population)|"The mean global BBPS scores and scores by colon segment are presented for the ITT population.~For each of the 3 colon segments (right, transverse and left colon) the BBPS score ranges from 0 - 3 (worst to best), and was assessed by 3 blinded experts:~unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared = 0~portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid = 1~minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well = 2~entire mucosa of colon segment seen well with no residual staining, small fragments of stool and/or opaque liquid = 3.~The global score is the total of the 3 segment scores ranging from 0 - 9 (worst to best). Reconciled scores were based on 3 blinded reviews. Results of analysis for the PP population for right + transverse colon segments presented separately."|Colonoscopy was performed on Day 2.|The ITT population consisted of all randomised patients who received even a partial dose of study treatment. Patients were assessed according to the randomised treatment, regardless of treatment received. Only patients with data available are included.|||units on a scale||Standard Deviation|Mean
2587273|NCT02320838|Primary|Nerve Conduction Latency Immediately After Treatment|The compound action potential latencies will be measured and will be expressed in ms.|immediately after treatment at 20 min.||||ms||Standard Deviation|Mean
2587274|NCT02320838|Primary|Thermal Pain Threshold During Treatment|The heat pain threshold will be measured by a computer controlled thermo-foil heating device and will be expressed in ºC|during treatment at 15 min.||||ºC||Standard Deviation|Mean
2587220|NCT02321462|Primary|Adjusted Percentage of Patients With Successful Overall Colon Preparation, Assessed by the Global Score of the Boston Bowel Preparation Scale (BBPS).|"The BBPS score for each colon segment (right, transverse and left colon) was assessed by 3 blinded experts as follows: 0=unprepared segment with mucosa not seen due to solid stool that cannot be cleared , 1=portion of mucosa of the segment seen, but other areas not well seen due to staining, residual stool and/or opaque liquid, 2=-minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of segment seen well, 3=entire mucosa of segment seen well with no residual staining, small fragments of stool and/or opaque liquid.~A reconciled score based on the 3 blinded reviews was used to calculate the global BBPS score, ranging from 0 to 9 (worst to best). A successful overall colon preparation was defined as a global score ≥6 for the 3 colon segments.~The percentage of patients with a successful preparation was determined using a logistic regression model, adjusted on centre, age class (<= 65; > 65), gender and inflammatory bowel disease (IBD) status."|Colonoscopy was performed on Day 2.|The per protocol (PP) population consisted of all randomised patients who received the preparation of study treatment (complete or partial), who underwent the colonoscopy procedure and for whom no major protocol violation occurred until colonoscopy. Patients were assessed according to the randomised treatment, regardless of treatment received.|||Adjusted percentage of patients||95% Confidence Interval|Number
2587221|NCT02321436|Secondary|Mean Duration of Concomitant Non-drug Therapy Sessions.|"The duration of non-drug therapy sessions that the subject received for UL spasticity in combination with injections of either Dysport® or placebo - up to and including the subject's last study visit - were recorded in the Electronic Case Report Form (eCRF) as part of concomitant medications and therapies evaluation at all study visits (Prior and Concomitant Non-Drug Therapies eCRF page). Overall duration of concomitant therapies in the indication of Post Stroke UL Spasticity was computed for the period from first administration of Dysport® or placebo to last study visit. Concomitant non-drug therapies were defined as received any time during study (on or after the day of the first injection of Dysport® or placebo) regardless of the start or stop date. For each subject, overlapping sessions were defined as one therapy session using the earliest start date as the start date and the latest start date as the stop date."|From baseline up to Week 28|This analysis was performed on the safety population which includes all randomised subjects who received the study medication.|||days||Standard Deviation|Mean
2587222|NCT02321436|Secondary|Number of Concomitant Non-drug Therapy Sessions.|"The number of non-drug therapy sessions that the subject received for UL spasticity in combination with injections of either Dysport® or placebo - up to and including the subject's last study visit - were recorded in the Electronic Case Report Form (eCRF) as part of concomitant medications and therapies evaluation at all study visits (Prior and Concomitant Non-Drug Therapies eCRF page). All concomitant therapies in the indication of Post Stroke UL Spasticity were counted by subject from first administration of Dysport® or placebo to last study visit. Concomitant non-drug therapies were defined as received any time during study (on or after the day of the first injection of Dysport® or placebo) regardless of the start or stop date. For each subject, overlapping sessions were defined as one therapy session using the earliest start date as the start date and the latest start date as the stop date."|From baseline up to Week 28|This analysis was performed on the safety population which includes all randomised subjects who received the study medication.|||Number of sessions|||Number
2587223|NCT02321436|Secondary|Global Assessment of Changes at Last Visit|"Global assessment of changes was assessed by the investigator from Week 4 up to (but not including) the visit when the reinjection criteria were met. This endpoint was assessed by the investigator using a 5-point Likert scale to answer the following question: How does your patient feel compared to his/her condition at the first visit?~Much better~Better~No change~Worse~Much worse~Results are reported overall for subjects with both symptomatic and asymptomatic spasticity."|From Week 4 up to Week 28|This efficacy analysis was performed on the ITT population which includes all randomised subjects who provided informed consent. No data is available for subjects who met their reinjection criteria at Visit 2 (Week 4).|||percentage of participants|||Number
2587224|NCT02321436|Secondary|Mean Change in Fugl-Meyer Assessment for Evaluation of UL Motor Impairment.|"The Fugl-Meyer assessment is a validated tool for measuring motor functioning, balance, sensation, and joint functioning in the upper or lower limbs of subjects with post-stroke hemiplegia. The assessment scale is comprised of 155 items across 5 domains: motor functioning, sensory functioning, balance, joint range of motion and joint pain. For this study, only the UL motor part was assessed using the following criteria:~A. Upper Extremity (from 0 to 36) B. Wrist (from 0 to 10) C. Hand (from 0 to 14) D. Coordination / Speed (from 0 to 6)~Total motor function scores (A-D [from 0 to 66]) were calculated and LS mean changes from baseline up to (but not including) the visit when the reinjection criteria were met were reported.~Higher values for change from baseline indicated a better outcome."|From baseline up to Week 28|This analysis was performed on the ITT population and includes all randomised subjects who provided informed consent.|||units on a scale||Standard Error|Least Squares Mean
2587225|NCT02321436|Secondary|Mean Change in MAS of the Primary Targeted Muscle Group.|Increased muscle tone in the primary muscle group (selected by the investigator at the first visit, based on his/her clinical judgement and in agreement with the subject, in one of the following muscle groups: elbow flexors or pronators, wrist flexors, or finger flexors) was assessed using the MAS. Scale ranges from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). Least Squares (LS) mean change from baseline to each subsequent visit (including the subject's last study visit) of the MAS score is reported.|From baseline up to Week 28|This analysis was performed on the ITT population which includes all randomised subjects who provided informed consent.|||units on a scale||Standard Error|Least Squares Mean
2587241|NCT02320903|Secondary|Achenbach System of Empirically-Based Assessment, Rule-breaking Subscale|The Achenbach System of Empirically-Based Assessment is a measure of youth problem behavior and psychiatric symptomatology that has parallel parent (report of teen) and youth (self-report) versions to allow for different perspectives on the problem. The parent version is called the Child Behavior Checklist (CBCL) and the youth version is called the Youth Self Report (YSR). Selected subscales from the CBCL and the YSR were administered before and after the 4 weeks of app usage, in this case, the rule-breaking subscale. Higher values indicate worse symptoms. Possible range on this subcale is 0 - 34; a score of 9 or higher indicates clinically significant rule-breaking, defined as rule-breaking that is higher than that of 93% of teens in the United States.|Baseline and Post assessment (end of 45-day app use period)|Parent/caregivers and youth/teens results were analyzed separately.|||units on a scale||Standard Deviation|Mean
2587226|NCT02321436|Primary|Time Between the Initial Injection and the Appearance of Reinjection Criteria as Evaluated by the Modified Ashworth Scale (MAS) and Spasticity Symptoms|"The appearance of increased muscle tone was assessed using the MAS (scale ranges from 0 [no increase in muscle tone] to 4 [affected part rigid in flexion or extension]). For confirmation of reinjection criteria appearance, a subject had to have a MAS score in the primary targeted muscle group of ≥2 and at least 1 of the following 4 criteria confirming signs of symptomatic spasticity in the UL:~A Numeric Pain Rating Scale (NPRS) pain score ≥ 4 (NPRS ranges from 0 [no pain] to 10 [severe pain])~An impact on passive function measured by a score of ≥ 1 on the 4-point Likert scale (scale ranges from 0 [no impact] to 3 [severe impact])~An impact on active function measured by a score of ≥ 1 on the 4-point Likert scale~An involuntary movements score ≥1 on the 4-point Likert scale in relevant upper limb.~Results are reported overall for subjects with both symptomatic and asymptomatic spasticity."|From Week 4 up to Week 28|This analysis was performed on the Intention-To-Treat (ITT) population which includes all randomised subjects who provided informed consent.|||days||95% Confidence Interval|Median
2587227|NCT02321111|Secondary|Effect of Eritoran on Intramyocellular Diacylglycerol and Ceramide Content|Intramyocellular diacylglycerol and ceramide content are determined by mass spectrometry. Higher levels have been associated with diabetes.|72 hours|Data were not collected due to lack of funding.||||||
2587228|NCT02321111|Secondary|Effect of Eritoran on Plasma Cytokine Concentration|TNF-alpha levels (tumor necrosis factor-alpha) are determined by ELISA. Higher level indicates higher inflammatory response. There is no established reference range.|72 hours||||pg/ml||Standard Error|Mean
2587229|NCT02321111|Secondary|Effect of Eritoran on TLR4 Expression on Peripheral Blood Monocytes|TLR4 expression on the peripheral blood monocytes is determined by flow cytometry using arbitrary units. Higher TLR4 expression indicates higher inflammatory response. There is no reference range.|72 hours|Data from 1 subject were not collected due to instrument failure. Therefore, data from 9 subjects were reported.|||AU||Standard Error|Mean
2587230|NCT02321111|Primary|Effect of Eritoran on Hepatic Insulin Sensitivity|Hepatic insulin sensitivity = is determined by euglycemic hyperinsulinemic clamp procedure. Endogenous glucose production or EGP (mg/kg/min) calculated from the clamp is measured. Lower EGP indicates better hepatic insulin sensitivity. There is no established reference range.|72 hours||||mg/kg/min||Standard Error|Mean
2587231|NCT02321111|Primary|Effect of Eritoran on Muscle Insulin Sensitivity|Muscle insulin sensitivity = muscle insulin sensitivity is determined by euglycemic hyperinsulinemic clamp procedure. M value (mg glucose / kg of body weight / minute) calculated from the clamp is measured. Higher M value indicates better insulin sensitivity. There is no established reference range.|72 hours||||mg/kg/min||Standard Error|Mean
2587232|NCT02321098|Secondary|Absence of Dermatophytes in Nail Samples Culture||Week 12||||participants|||Number
2587233|NCT02321098|Primary|Measurement of Antifungal Activity of Loceryl Nail Lacquer|Measurement of diameter of zones of inhibition (mm) produced by residual drug in toenails|Week 12||||Milimeter||Standard Deviation|Mean
2587234|NCT02320903|Secondary|Loeber Parental Knowledge Scale|Youth report of how much parents actually know about the youth's whereabouts/activities. This 5-item scale has a scored range of 0 (minimum score) - 15 (maximum score), with high scores indicating that the parent knows more about what teens are actually doing.|over 30 days of app usage|Youth/teens who used app only|||units on a scale||Standard Deviation|Mean
2587235|NCT02320903|Secondary|Parental Locus of Control Scale|Degree to which parents feel efficacious and confident in managing parenting challenges. This 20-item scale has a scored range of 0 (minimum score) - 40 (maximum score), with high scores indicating that the parent has a higher sense of feeling efficacious in their role as a parent.|Change over 30 days of app usage (baseline to post-assessment)|All parents/caregivers who completed the study.|||units on a scale||Standard Deviation|Mean
2587236|NCT02320903|Secondary|Perceived Stress Scale (PSS)|Degree to which parents are experiencing stress related to parenting. This 10-item scale has a scored range of 0 (minimum score) - 40 (maximum score), with high scores indicating more stress related to parenting.|Change over 30 days of app usage (baseline to post-assessment)|All parents/caregivers who completed the study.|||units on a scale||Standard Deviation|Mean
2587237|NCT02320903|Secondary|Loeber Parental Effectiveness Scale|"Degree to which parents feel that their parenting techniques are working in terms of managing teen behavior challenges. This 3-item scale has a scored range of 0 (minimum score) - 8 (maximum score), with high scores indicating better discipline effectiveness (e.g., I feel like the punishment I give works in curbing youth behavior)."|Change over 30 days of app usage (baseline to post-assessment)|All parents/caregivers who completed the study.|||units on a scale||Standard Deviation|Mean
2587238|NCT02320903|Secondary|Loeber Parental Consistency Scale|This measure of extent to which parents are consistent in their rules, expectations, and discipline techniques with youth was administered to parents/caregivers and to youth/teens before and after the 4 weeks of app usage. This 5-item scale has a scored range of 0 (minimum score) - 10 (maximum score), with high scores indicating more consistent / better parental discipline follow-through.|Baseline and Post assessment (end of 45-day app use period)|Parent/caregivers and youth/teens results were analyzed separately.|||units on a scale||Standard Deviation|Mean
2587239|NCT02320903|Secondary|Loeber Positive Parenting Scale|This measure of extent to which parents express warmth and encouragement to youth was administered to parents/caregivers and to youth/teens before and after the 4 weeks of app usage.This 9-item scale has a scored range of 0 (minimum score) - 18 (maximum score), with high scores indicating more parental positivity.|Baseline and Post assessment (end of 45-day app use period)|Parent/caregivers and youth/teens results were analyzed separately.|||units on a scale||Standard Deviation|Mean
2587240|NCT02320903|Secondary|Loeber Parental Supervision Scale|This measure of extent to which parents supervise and monitor youth whereabouts was administered to parents/caregivers and to youth/teens before and after the 4 weeks of app usage.This 8-item scale has a scored range of 0 (minimum score) - 16 (maximum score), with high scores indicating more or better parental supervision/monitoring.|Baseline and Post assessment (end of 45-day app use period)|Parent/caregivers and youth/teens results were analyzed separately.|||units on a scale||Standard Deviation|Mean
2587261|NCT02320838|Secondary|Baseline Nerve Conduction Latency|The compound action potential latencies will be measured and will be expressed in ms.|Baseline at 0 min.||||ms||Standard Deviation|Mean
2601701|NCT02150837|Secondary|Lean Mass|Lean mass expressed as an absolute change from baseline.|4 weeks||||Pounds||Standard Deviation|Mean
2587242|NCT02320903|Secondary|Achenbach System of Empirically-Based Assessment, Depression Subscale|The Achenbach System of Empirically-Based Assessment is a measure of youth problem behavior and psychiatric symptomatology that has parallel parent (report of teen) and youth (self-report) versions to allow for different perspectives on the problem. The parent version is called the Child Behavior Checklist (CBCL) and the youth version is called the Youth Self Report (YSR). Selected subscales from the CBCL and the YSR were administered before and after the 4 weeks of app usage, in this case, the depression subscale. Higher values indicate worse symptoms. Possible range on this subcale is 0 - 26; a score of 8 or higher indicates clinically significant depression, defined as depressive symptoms higher than that of 93% of teens in the United States.|Baseline and Post assessment (end of 45-day app use period)|Parent/caregivers and youth/teens results were analyzed separately. Least squares means show amount of difference from pre- to post-testing in paired samples T tests.|||units on a scale||Standard Deviation|Mean
2587243|NCT02320903|Secondary|Achenbach System of Empirically-Based Assessment, Aggression Subscale|The Achenbach System of Empirically-Based Assessment is a measure of youth problem behavior and psychiatric symptomatology that has parallel parent (report of teen) and youth (self-report) versions to allow for different perspectives on the problem. The parent version is called the Child Behavior Checklist (CBCL) and the youth version is called the Youth Self Report (YSR). Selected subscales from the CBCL and the YSR were administered before and after the 4 weeks of app usage, in this case, the aggression subscale. Higher values indicate worse symptoms. Possible range on this subcale is 0 - 36; a score of 13 or higher indicates clinically significant aggression, defined as aggression that is higher than that of 93% of teens in the United States.|Baseline and Post assessment (end of 45-day app use period)|Parent/caregivers and youth/teens results were analyzed separately.|||units on a scale||Standard Deviation|Mean
2587244|NCT02320903|Primary|App Satisfaction - I Like Getting Prompts and Reminders|"Youth/teens in the study were prompted 3 times/week during period of app usage to rate, on a scale of 1 (strongly disagree) to 7 (strongly agree), I like getting prompts and reminders from the app."|up to 45 days|Only teens were provided with this question.|||units on a scale||Standard Deviation|Mean
2587245|NCT02320903|Primary|App Satisfaction Rating - Parent is Noticing and Rewarding Good Behavior|Three times each week, at random, youth/teens were asked to rate on a scale of 1 (strongly disagree) to 7 (strongly agree), my parent is noticing and rewarding good behavior. All ratings were averaged across full period of app use.|up to 45 days|Only youth/teens were provided this question.|||units on a scale||Standard Deviation|Mean
2587246|NCT02320903|Primary|App Satisfaction Rating - Overall Satisfaction|Parent/caregiver and teen was prompted randomly 3 times each week to rate on a scale of 1 (totally unsatisfied) to 7 (completely satisfied), overall, how satisfied are you with the app today?|up to 45 days|Parent/caregiver and teen participants were analyzed separately on this measure.|||units on a scale||Standard Deviation|Mean
2587247|NCT02320903|Primary|App Satisfaction Rating - I Have Ways to Intervene With my Teen.|Parent/caregiver was prompted randomly 3 times each week to rate on a scale of 1 (strongly disagree) to 7 (completely agree), the app gives me new ways of intervening with my teen.|up to 45 days|Only parent/caregivers were given this question.|||units on a scale||Standard Deviation|Mean
2587248|NCT02320903|Primary|App Satisfaction Rating - the App Was Helpful Today|Parent/caregiver was prompted randomly 3 times each week to rate on a scale of 1 (strongly disagree) to 7 (completely agree), how helpful was the app to you today?|up to 45 days|Only parent/caregivers were administered this measure.|||units on a scale||Standard Deviation|Mean
2587249|NCT02320903|Primary|App Usage - View Progress Graph (Points Earned Over Time)|Youth/teen points earned over time were depicted on a graph for each day of use. To view the graph, caregivers/parents and youth/teens had to click on an app button.|up to 45 days|Analyses performed separately for parents and teens.|||Participants|||Count of Participants
2587250|NCT02320903|Primary|App Usage - Viewed Parent Coaching Videos|The app included 5 brief video vignettes depicting an effective parenting technique.|up to 45 days|Only the parent/caregiver version of the app had this feature.|||Participants|||Count of Participants
2587251|NCT02320903|Primary|App Usage - Viewed Notifications Regarding Behavioral Expectations Met/Not Met|The percentage of participants who viewed notifications that the teen was or was not meeting a behavioral expectation. Both parents and teens had this capability.|up to 45 days|All parent/caregiver and teen participants analyzed|||Participants|||Count of Participants
2587252|NCT02320903|Primary|App Usage - Parent Set Geolocation Expectations for the Teen.|Percentage of parent/caregivers who set either required or off-limits locations for their teens.|up to 45-days||||Participants|||Count of Participants
2587253|NCT02320903|Primary|App Usage - Set up and Allocated / Earned Points (Rewards) for Positive Teen Behavior|How many parents/caregivers set up a reward system and redeemed at least some points for the teen.|up to 45-days|Percent of caregivers who set and allocated points to the teen (teens who had points redeemed).|||Participants|||Count of Participants
2587254|NCT02320903|Primary|App Usage - Parent Set up / Modified an App-based Behavior Plan for the Teen|Percent of parents who set up a behavior plan for teen using app features.|up to 45-days|All parent/caregiver and teen participants analyzed.|||Participants|||Count of Participants
2587255|NCT02320838|Other Pre-specified|Skin Temperature|Skin temperature (ºC) will be recorded in all assessment times.|Baseline, during treatment at 15 min., immediately after treatment at 20 min., at 20 min. post-treatment, at 40 min. post-treatment||||ºC||Standard Deviation|Mean
2587256|NCT02320838|Secondary|Tactile Threshold Post-treatment 40 Min.|The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton|at 40 min. post-treatment||||mN||Standard Deviation|Mean
2587257|NCT02320838|Secondary|Tactile Threshold Post-treatment 20 Min.|The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton|at 20 min. post-treatment||||mN||Standard Deviation|Mean
2587258|NCT02320838|Secondary|Baseline Tactile Threshold|The tactile threshold will be measured with Von Frey filaments and will be expressed in millinewton|Baseline at 0 min.||||mN||Standard Deviation|Mean
2587259|NCT02320838|Secondary|Nerve Conduction Latency Post-treatment 40 Min.|The compound action potential latencies will be measured and will be expressed in ms.|at 40 min. post-treatment||||ms||Standard Deviation|Mean
2587260|NCT02320838|Secondary|Nerve Conduction Latency Post-treatment 20 Min.|The compound action potential latencies will be measured and will be expressed in ms.|at 20 min. post-treatment||||ms||Standard Deviation|Mean
2587276|NCT02320825|Secondary|Quality of Life Between the Two Cohorts Determined Through Patient-reported Responses of the BPI|will be determined through patient-reported responses of the BPI. Pain severity at its worst (question #5) and the average of the pain interference (average of question #9)|2 years|Data were not collected||||||
2587277|NCT02320825|Secondary|Treatment-related Toxicity Using CTCAE v4.0|Adverse events will be assessed by the investigators according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|2 years|Data were not collected||||||
2587278|NCT02320825|Primary|Local Tumor Control Using MRI or CT|will be radiographically determined according to routine standard of care post-surgical and post-treatment imaging (MRI or CT) of the spine. Local tumor control will be defined as the lack of local tumor progression at the irradiated site on follow-up imaging.|2 years|Data were not collected||||||
2587279|NCT02320812|Secondary|Change in Mean Best Corrected Visual Acuity (BCVA)|change in mean best corrected visual acuity in test eye versus untreated eye; BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. Change between baseline and month 12 is reported.|12 months|all treated subjects|||number of letters read correctly||Full Range|Mean
2587280|NCT02320812|Primary|Number of Subjects With Adverse Events as a Measure of Safety and Tolerability|proportion of subjects with treatment emergent adverse events (TEAE), related TEAE and severe TEAE|12 months|all treated subjects|||Participants|||Count of Participants
2587281|NCT02320721|Post-Hoc|Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year: By Age Categorical Data During the 26 Weeks of Treatment|Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).|Baseline up to Week 26|Safety population.|||events per participant year|||Number
2587282|NCT02320721|Other Pre-specified|Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) Event Rate Per Participant Year During the 26 Weeks of Treatment|Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).|Baseline up to Week 26|Safety population.|||events per participant year|||Number
2587283|NCT02320721|Other Pre-specified|Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia, Severe and/or Confirmed Hypoglycemia) During the 26 Weeks of Treatment|Hypoglycemia events were hypoglycemia of any category, severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); documented symptomatic hypoglycemia (symptoms of hypoglycemia with plasma glucose ≤3.9 mmol/L [70 mg/dL]); confirmed hypoglycemia (with or without symptoms of hypoglycemia and plasma glucose ≤3.9 mmol/L).|Baseline up to Week 26|Safety population included all randomized participants who actually received at least 1 dose or part of a dose of investigational medicinal product (IMP) and analyzed according to the treatment actually received.|||percentage of participants|||Number
2587284|NCT02320721|Secondary|Percentage of Participants Requiring Rescue Therapy Over the 26 Weeks of Treatment|Routine fasting self-monitored plasma glucose (SMPG) and central laboratory FPG (and HbA1c after Week 14) values were used to determine the requirement of rescue medication. Threshold values at Week 14: FPG >200 mg/dL (11 mmol/L), or HbA1c >8.5%.|Baseline up to Week 26|ITT population.|||percentage of participants|||Number
2587285|NCT02320721|Secondary|Change in World Health Organization-5 (WHO-5) Well-Being Questionnaire Percentage Score From Baseline to Week 26|WHO-5 well-being index evaluates positive psychological well-being during the past 2 weeks and consists of 5 questions, each rated on a 6-point Likert scale from 0 (not present) to 5 (constantly present). Total raw score was transformed into a percentage score ranging from 0 (worst possible quality of life) to 100 (best possible quality of life).|Baseline, Week 26|ITT population. Here ‘Overall number of participants analyzed’ signifies participants with available data for this outcome measure.|||scores on a scale||Standard Error|Least Squares Mean
2587286|NCT02320721|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|Adjusted LS means from multiple imputation approach including post baseline values during the 26-week randomized period.|Baseline, Week 26|ITT population. Here 'Overall number of participants analyzed' signifies participants with available data for this outcome measure.|||mmol/L||Standard Error|Least Squares Mean
2587287|NCT02320721|Secondary|Percentage of Participants With HbA1c <7.5% or <7.0% at Week 26 and No Severe and/or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia During 26-Week Randomized Period|Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).|Baseline up to Week 26|ITT population.|||percentage of participants|||Number
2587288|NCT02320721|Secondary|Percentage of Participants With HbA1c <7.5% or HbA1c <7% During 26-Week Randomized Period|Participants without any available HbA1c assessment at Week 26 were considered as non-responders in the analyses.|Baseline up to Week 26|ITT population.|||percentage of participants|||Number
2587289|NCT02320721|Secondary|Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Hypoglycemia Occurring at Any Time of the Day During 26-Week Randomized Period|Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).|Baseline up to Week 26|ITT population.|||percentage of participants|||Number
2587683|NCT02315755|Secondary|Correlation Coefficient Between Efficacy and Dose Modifications Due to AEs||Baseline up to Month 12 follow-up visit|Analysis was performed on all enrolled participants.|||Correlation coefficient|||Number
2587290|NCT02320721|Secondary|Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (00:00 to 05:59 Hours) During 26-Week Randomized Period|Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).|Baseline up to Week 26|ITT population.|||percentage of participants|||Number
2587291|NCT02320721|Secondary|Percentage of Participants With At Least One Severe and/ or Confirmed (≤3.9 mmol/L [70 mg/dL]) Nocturnal Hypoglycemia (22:00 to 08:59 Hours Next Morning) During 26-Week Randomized Period|Estimated percentages from multiple imputation approach including data from the 26-week randomized period. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose ≤3.9 mmol/L (70 mg/dL).|Baseline up to Week 26|ITT population.|||percentage of participants|||Number
2587292|NCT02320721|Primary|Change in HbA1c From Baseline to Week 26|Adjusted least square (LS) means were obtained from analysis of covariance (ANCOVA) after multiple imputation of missing data including post baseline HbA1c data during the 26-week randomized period.|Baseline, Week 26|Intent-to-treat (ITT) population included all randomized participants regardless of whether the treatment kit was used, and analyzed according to the treatment group allocated by randomization.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2587293|NCT02320695|Secondary|Mean Clinician Rating of Overall Wound Condition on Day 8|The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity.|Day 8|The Intent-to-Treat (ITT) analysis population included all randomized subjects who had initiated the tape-stripping procedures.|||units on a scale||Standard Deviation|Mean
2587294|NCT02320695|Secondary|Mean Clinician Rating of Overall Wound Condition on Day 1|The clinician evaluated the wound using the following scale: 0 = minimal severity, 10 = maximal severity.|Day 1|The Intent-to-Treat (ITT) analysis population included all randomized subjects who had initiated the tape-stripping procedures.|||units on a scale||Standard Deviation|Mean
2587295|NCT02320695|Primary|Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation One Minute After Investigational Product Application|The stinging sensation was assessed by the subject using the following scale: 0 = no stinging sensation, 1 = mild stinging sensation, 2 = moderate stinging sensation, and 3 = severe stinging sensation at post-tape stripping and one minute after investigational product application. Change from post-tape striping was calculated as the subject assessment of stinging sensation at one minute after investigational product application minus the subject assessment of stinging sensation at post-tape stripping.|Post-tape stripping to one minute after investigational product application|Analysis was based on all randomized subjects who initiated the tape-stripping procedures and perceived sting sensation immediately after the application of alcohol.|||units on a scale||Standard Deviation|Mean
2587296|NCT02320695|Primary|Mean Change From Post-Tape Stripping in Subject Assessment of Stinging Sensation Immediately After Investigational Product Application|The stinging sensation was assessed by the subject using the following scale: 0 = no stinging sensation, 1 = mild stinging sensation, 2 = moderate stinging sensation, and 3 = severe stinging sensation at post-tape stripping and immediately after product application. Change from post-tape striping was calculated as the subject assessment of stinging sensation immediately after investigational product application minus the subject assessment of stinging sensation at post-tape stripping.|Post-tape stripping to immediately after investigational product application|Analysis was based on all randomized subjects who initiated the tape-stripping procedures and perceived sting sensation immediately after the application of alcohol.|||units on a scale||Standard Deviation|Mean
2587297|NCT02320487|Secondary|Percentage of Participants With Adverse Events (AEs)|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.|Day 1 up to 46 months|The safety population included participants who received any amount of study treatment.|||percentage of participants|||Number
2587298|NCT02320487|Secondary|Number of Hospitalizations Due to Adverse Events (AEs)|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.|Day 1 up to 46 months|The safety population included participants who received any amount of study treatment.|||hospitalizations||Standard Deviation|Mean
2587299|NCT02320487|Secondary|Change From Baseline in the EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) Score|The EORTC Quality of Life Questionnaire-Chronic Lymphocytic Leukemia 16 (QLQ-CLL16) module included assessments of fatigue, treatment side effects, disease symptoms, infection, social activities, and future health worries. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be a minimally important difference to participants. A positive change from Day 1, Cycle 1 (baseline) indicates improvement. EOT=end of treatment.|Day 1 Cycles 1 (baseline), 3, 6; end of treatment, 2 months after last dose, every 3 months thereafter for 2 years (up to 46 months) (1 cycle = 28 days)|The PRO Evaluable Population included all ITT participants in the study who received any dose of study treatment (obinutuzumab or bendamustine) and had both a non-missing baseline and at least one post-baseline PRO assessment. Data were not collected for the second year of follow up.|||score on a scale||Standard Deviation|Mean
2587331|NCT02320149|Secondary|Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 9|ITT population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
2587300|NCT02320487|Secondary|Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score|The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive change from Day 1, Cycle 1 (baseline) indicates improvement. EOT=end of treatment.|Day 1 Cycles 1 (baseline), 3, 6; end of treatment, 2 months after last dose, every 3 months thereafter for 2 years (up to 46 months) (1 cycle = 28 days)|The PRO (patient-reported outcome) Evaluable Population included all ITT participants in the study who received any dose of study treatment (obinutuzumab or bendamustine) and had both a non-missing baseline and at least one post-baseline PRO assessment. Data were not collected for the second year of follow up.|||score on a scale||Standard Deviation|Mean
2587301|NCT02320487|Secondary|Ctrough of Obinutuzumab After Cycle 4|Ctrough is the measured concentration of a drug at the end of a dosing interval at steady state.|Pre-infusion (0 hours) on Day 1 Cycle 5 (1 cycle = 28 days)|The PK (pharmacokinetic) Evaluable Population included all ITT participants in the study who received any dose of study drug (obinutuzumab or bendamustine) and had at least one PK assessment. Data are reported for evaluable participants.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2587302|NCT02320487|Secondary|Minimum Observed Concentration (Ctrough) of Obinutuzumab After Cycle 2|Ctrough is the measured concentration of a drug at the end of a dosing interval at steady state.|Pre-infusion (0 hours) on Day 1 Cycle 3 (1 cycle = 28 days)|The PK (pharmacokinetic) Evaluable Population included all ITT participants in the study who received any dose of study drug (obinutuzumab or bendamustine) and had at least one PK assessment. Data are reported for evaluable participants.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2587303|NCT02320487|Secondary|Duration of MRD-Negativity in Peripheral Blood Among Participants Who Achieved MRD-Negative Status|MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity (<1 CLL cell detected in 10,000 leukocytes) in peripheral blood. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture. Duration of MRD-negativity among patients who achieved MRD negativity in the study is defined as the period between the first occurrence of MRD-negative status and a subsequent MRD-positive status.|Baseline up to 46 months|The mITT population included enrolled participants who received at least one dose of BG. Data are reported for evaluable participants.|||months||95% Confidence Interval|Median
2587304|NCT02320487|Secondary|Time to MRD-Negative Status in Peripheral Blood|MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity if the value is <10^-4 (<1 CLL cell detected in 10,000 leukocytes) in peripheral blood. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture. Time to MRD-negative status is defined as the time between MRD positivity (>= 10^-4) or the time of first dose treatment for patients who were missing MRD status assessment at baseline to the first achievement of MRD negativity in the peripheral blood.|Baseline up to 46 months|The mITT population included enrolled participants who received at least one dose of BG.|||months||95% Confidence Interval|Median
2587305|NCT02320487|Secondary|Percentage of Participants Who Achieved MRD-Negative Status in Peripheral Blood at Any Time During the Study|MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity (<1 CLL cell detected in 10,000 leukocytes) in peripheral blood. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture.|Baseline up to 46 months|The mITT population included enrolled participants who received at least one dose of BG. Data are reported for evaluable participants.|||percentage of participants||95% Confidence Interval|Number
2587306|NCT02320487|Secondary|Percentage of Participants Who Achieved Minimal Residual Disease (MRD)-Negative Status in Bone Marrow at Any Time During the Study|MRD was assessed by 4-color flow cytometry, using iwCLL criteria for MRD negativity (<1 CLL cell detected in 10,000 leukocytes) in bone marrow aspirate. Flow cytometry provides rapid analysis of multiple characteristics of single cells by using light to count and profile cells in a fluid mixture.|Up to 46 months|The mITT population included enrolled participants who received at least one dose of BG. Data are reported for evaluable participants.|||percentage of participants||95% Confidence Interval|Number
2587307|NCT02320487|Secondary|Overall Survival (OS)|OS was defined as the time from the start of induction treatment to death from any cause. Participants who did not experience death or disease progression before the end of the study were censored on the day of the last available assessment.|Day 1 until death from any cause (up to 46 months)|The mITT population included enrolled participants who received at least one dose of BG.|||months||95% Confidence Interval|Median
2587308|NCT02320487|Secondary|Progression-Free Survival (PFS), as Determined by the Investigator Using iwCLL NCI-WG Guidelines|PFS was defined as the time from the start of induction treatment (Day 1) to the first occurrence of disease progression, relapse as determined by the investigator using iwCLL NCI WG guidelines, or death (within 28 days after the last dose of study drug), whichever occurred first. Disease progression: at least one of the following: lymphadenopathy; increase in the liver or spleen size by 50% or more or the appearance of hepatomegaly or splenomegaly; an increase in the number of blood lymphocytes by 50% or more with at least 5000 B lymphocytes per microliter; transformation to a more aggressive histology; occurrence of cytopenia (neutropenia, anemia, or thrombocytopenia) attributable to CLL. Relapse: Having achieved CR or PR, but after a period of 6 or more months, having demonstrated evidence of disease progression. Participants who did not experience death or disease progression before the end of the study were censored on the day of the last available assessment.|Day 1 until disease progression, relapse, or death from any cause, whichever occurred first (up to 46 months)|The mITT population included enrolled participants who received at least one dose of BG.|||months||95% Confidence Interval|Median
2587432|NCT02318979|Secondary|Metabolic Demand|The investigators will measure rates of oxygen consumption and carbon dioxide production during running to determine the optimal prosthesis for each participant.|4 days|Best metabolic cost for a running-specific prosthetic configuration.|||Net CoT (J/kg/m)||Standard Error|Mean
2587309|NCT02320487|Secondary|Duration of Response Among Participants With Objective Response of CR or PR, as Determined by the Investigator Using iwCLL NCI-WG Guidelines|Duration of response was defined as the time from the first assessment of CR, CRi, PR, or nodular partial response (nPR) to the first documentation of PD or death, whichever occurred first. CR, CRi, and PR are identified in previous outcome measures. Participants with lymphoid nodules who otherwise met CR criteria were considered nPR. Participants with post-baseline response assessments (excluding progressive disease) but with no end-of-induction treatment response available were censored on Day 1, and those with end-of-induction treatment response available but who did not experience death or disease progression before the end of the study were censored on the day of the last available assessment.|From the first assessment of CR, CRi, PR, or nPR (at up to approximately 228 to 258 days) until disease progression, relapse, or death from any cause, whichever occurred first (up to 46 months)|The mITT population included enrolled participants who received at least one dose of BG. Analysis performed for participants with response.|||months||95% Confidence Interval|Median
2587310|NCT02320487|Secondary|Percentage of Participants With Objective Response of CR or Partial Response (PR) at the End of Induction Therapy, as Determined by the Investigator Using iwCLL NCI-WG Guidelines|CR is defined in the previous outcome measure. The definition of PR required that the following be documented for minimum 2 months: >/= 50% decrease in peripheral blood lymphocytes from Baseline; reduction in lymphadenopathy; >/= 50% reduction in spleen or liver enlargement; and CBC with one of the following without need for transfusion or exogenous growth factors: polymorphonuclear leukocytes >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L or >/= 50% improvement from Baseline, or hemoglobin > 11.0 g/dL or >/= 50% improvement from Baseline.|2 to 3 months after the last infusion of study treatment (up to approximately 228 to 258 days)|The mITT population included enrolled participants who received at least one dose of BG.|||percentage of participants||95% Confidence Interval|Number
2587311|NCT02320487|Primary|Percentage of Participants With Complete Response (CR), as Determined by the Investigator Using International Workshop on Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (iwCLL NCI-WG) Guidelines|The CR rate was defined as CR or CR with incomplete blood count recovery (CRi), assessed by the investigator according to iwCLL NCI-WG criteria. The definition of confirmed CR required all of the following criteria as assessed at least 2 months after completion of therapy: peripheral blood lymphocytes < 4 times 10^9 cells/L; absence of significant lymphadenopathy, hepatomegaly, or splenomegaly due to CLL involvement; absence of constitutional symptoms; normal complete blood count (CBC) without need for transfusion or exogenous growth factors, as exhibited by neutrophils >/= 1.5 times 10^9 cells/L, platelets > 100 times 10^9 cells/L, and hemoglobin > 11.0 g/dL; normocellular BM aspirate with < 30% lymphocytes; absence of lymphoid nodules; and BM biopsy without CLL activity. Those fulfilling CR criteria but who have persistent anemia, thrombocytopenia, or neutropenia were considered CRi.|2 to 3 months after the last infusion of study treatment (up to approximately 228 to 258 days)|The modified intent-to-treat (mITT) population included enrolled participants who received at least one dose of BG.|||percentage of participants||95% Confidence Interval|Number
2587312|NCT02320396|Secondary|"Percentage of Participants With Impression Assessments of Better or Much Better as Assessed Participants at Week 2"|"The participant evaluated their symptoms of allergic rhinitis at the end of the study (2 week visit or discontinuation visit) compared with those at the start of the study period (based on their recollection/memory of their symptoms, no formal baseline assessment) and recorded in their Subject Allergy Diary their impression of study drug on effect according to 6 grades: Much better, Better, Slightly better, Unchanged, Worse, or Unevaluable. The percentage of participants with assessments of Better and Much better graded by the participant (Participant's Impression Rate) was reported and analyzed using Odds Ratio analysis."|From Baseline to Week 2|Participants in the FAS (all randomized participants who took ≥1 dose of study treatment) with available impression data.|||percentage of participants|||Number
2587313|NCT02320396|Secondary|"Percentage of Participants With Impression Assessments of Better or Much Better as Assessed by the Investigator at Week 2"|"The investigator assessed the participant's symptoms of allergic rhinitis and nasal findings at the end of the study (2 week visit or discontinuation visit) compared with those at the start of the study period (based on their recollection/memory of the participant's symptoms, no formal baseline assessment) and evaluated their impression of study drug on effect according to 6 grades: Much better, Better, Slightly better, Unchanged, Worse, or Unevaluable. The evaluation result and reason for judgment (if needed) was recorded in the participant's case report form. The investigator's impression was evaluated based on the symptoms for allergic rhinitis, nasal findings and participant's own impression at Week 2. The percentage of participants with assessments of Better and Much better graded by the investigator (Investigator's Impression Rate) was reported and analyzed using Odds Ratio analysis."|From Baseline to Week 2|Participants in the FAS (all randomized participants who took ≥1 dose of study treatment) with available impression data.|||percentage of participants|||Number
2587314|NCT02320396|Secondary|Change From Baseline in Interference With Daily Activities Score at Week 1, Week 2, and During 2 Weeks of Therapy|Interference of allergic rhinitis symptoms with overall daily activities (such as work, study, housekeeping, sleep, or outing) was rated by the participant according to the following scale: 0=none, 1= symptoms cause few troubles, 2=symptoms cause intermediate problems between 1 and 3, 3=nasal symptoms cause painful and complicating daily life, or 4 = symptoms make daily activities impossible. Interference with daily activities scores ranged from 0 to 4 maximum, with a higher score indicating greater interference with daily activities. Baseline measurement was an average of scores for 3 days prior to treatment. Post-baseline measurement for Week 1 was an average of scores from Day 1 to Day 7. Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement - BL measurement.|Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average), Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
2587350|NCT02319967|Secondary|Self-management Practices After ED Discharge: Number of Participants Who Attended an Outpatient Appointment With Patient-identified Asthma Provider|Count of participants who attended follow-up appointment with patient-identifier asthma provider within 4 weeks of discharge|4 weeks post index ED discharge||||Participants|||Count of Participants
2587315|NCT02320396|Secondary|Change From Baseline in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) During 2 Weeks of Therapy|Eye symptoms rated in the participant's diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. BL measurement was an average of scores for 3 days prior to treatment. Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement - BL measurement.|Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
2587316|NCT02320396|Secondary|Change From Baseline to Week 2 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes)|Eye symptoms rated in the participant's diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. Baseline measurement was an average of scores for 3 days prior to treatment. Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Change from BL = Post BL measurement - BL measurement.|Baseline, Day 8 to 13 (Week 2) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
2587317|NCT02320396|Secondary|Change From Baseline to Week 1 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes)|Eye symptoms rated in the participant's diary included eye pruritis (eye itching scored from 0 [none] to 4 [severe eye itching, requiring frequent rubbing of eye]) and watering eyes (scored from 0 [none] to 4 [severe eye watering requiring frequent wiping of eyes]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. Baseline measurement was an average of scores for 3 days prior to treatment. Post-baseline measurement for Week 1 was an average of scores from Day 1 to Day 7. Change from BL = Post BL measurement - BL measurement.|Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
2587318|NCT02320396|Secondary|Change From Baseline in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) During 2 Weeks of Therapy|"Nasal symptoms sub-scores rated in the participant's diary included sneezing (daily frequency of attacks scored from 0 [<1 time or none] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or none] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement - BL measurement."|Baseline, Day 1 to Day 13 (Weeks 1 through 2 average)|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
2587319|NCT02320396|Secondary|Change From Baseline to Week 2 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)|"Nasal symptoms sub-scores rated in the participant's diary included sneezing (daily frequency of attacks scored from 0 [<1 time or none] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or none] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Change from BL = Post BL measurement - BL measurement."|Baseline, Day 8 to 13 (Week 2 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
2587320|NCT02320396|Secondary|Change From Baseline to Week 1 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching)|"Nasal symptoms sub-scores rated in the participant's diary included sneezing (daily frequency of attacks scored from 0 [<1 time or none] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or none] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 1 was an average of scores from Day 1 to Day 7. Change from BL = Post BL measurement - BL measurement."|Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
2587351|NCT02319967|Secondary|Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Inhaled Corticosteroids or Other Controller|Count of participants who filled prescription for inhaled corticosteroids or other controller within 7 days of discharge|7 days post index ED discharge||||Participants|||Count of Participants
2587321|NCT02320396|Secondary|Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment|"The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 [<1 time or none] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or none] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant's diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 1 was an average from Day 1 to Day 7 and post-BL measurement for Week 2 was an average from Day 8 to Day 13. Change from BL = Post BL measurement - BL measurement."|Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average) of double-blind treatment|The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation.|||units on a scale||95% Confidence Interval|Least Squares Mean
2587322|NCT02320396|Primary|Number of Participants Who Discontinue Study Drug Due to an AE|An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE.|Up to 2 weeks|APaT; all participants who received ≥1 dose of study treatment.|||participants|||Number
2587323|NCT02320396|Primary|Number of Participants Who Experience at Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE.|Up to 4 weeks (Up to 2 weeks after last dose of study drug)|All Participants as Treated (APaT); all participants who received ≥1 dose of study treatment.|||participants|||Number
2587324|NCT02320396|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) During 2 Weeks of Therapy|"The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 [<1 time or none] to 4 [≥21 times]), rhinorrhea (daily frequency of blowing nose scored from 0 [<1 time or none] to 4 [≥21 times]), nasal congestion (scored from 0 [no nasal blockage] to 4 [completely obstructed all day]), and nasal itching (scored from 0 [none] to 4 [nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant's diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement was an average from Day 1 to Day 13 (2 week average). Change from BL = Post BL measurement - BL measurement."|Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment|The Full Analysis Set (FAS); all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation (average score of 2 weeks).|||units on a scale||95% Confidence Interval|Least Squares Mean
2587325|NCT02320227|Primary|Number of Participants With Observed Local Edema|Number of participants with observed edema by OB/GYN examination.|14 days||||participants|||Number
2587326|NCT02320227|Primary|Number of Participants With Observed Local Erythema|Number of participants with observed local erythema by OB/GYN examination.|14 Days||||participants|||Number
2587327|NCT02320214|Primary|Number of Participants With Observed Local Edema|Number of participants with observed edema by OB/GYN examination.|14 Days|female only|||participants|||Number
2587328|NCT02320214|Primary|Number of Participants With Observed Local Erythema|Number of participants with observed erythema by OB/GYN examination.|14 Days|female only|||participants|||Number
2587329|NCT02320149|Secondary|Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 3|ITT population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
2587330|NCT02320149|Secondary|Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 6|ITT population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
2587352|NCT02319967|Secondary|Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Systemic Corticosteroids|Count of participants who filled a prescription for systemic corticosteroids within 7 days of discharge|7 days post index ED discharge||||Participants|||Count of Participants
2587332|NCT02320149|Secondary|Absolute Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 12|ITT population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
2587333|NCT02320149|Secondary|Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 3|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 3|ITT population included all randomized participants.|||percent change in lesion count||Standard Error|Least Squares Mean
2587334|NCT02320149|Secondary|Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 6|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 6|ITT population included all randomized participants.|||percent change in lesion count||Standard Error|Least Squares Mean
2587335|NCT02320149|Secondary|Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 9|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 9|ITT population included all randomized participants.|||percent change in lesion count||Standard Error|Least Squares Mean
2587336|NCT02320149|Secondary|Percent Change From Baseline in Facial Noninflammatory Lesion Counts at Week 12|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Noninflammatory lesion counts were based on the following definitions: open comedones (blackheads): noninfected plugged hair follicle with a dilated/open orifice, black in color; closed comedones (whiteheads): noninfected plugged hair follicle with a small (microscopic) opening at the surface of the skin. A negative change from Baseline indicates that the number of noninflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 12|ITT population included all randomized participants.|||percent change in lesion count||Standard Error|Least Squares Mean
2587337|NCT02320149|Secondary|Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 3|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 3|ITT population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
2587338|NCT02320149|Secondary|Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 6|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Weeks 6|ITT population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
2587339|NCT02320149|Secondary|Absolute Change From Baseline in Facial Inflammatory Lesion Counts at Week 9|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 9|ITT population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
2587340|NCT02320149|Secondary|Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 3|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 3|ITT population included all randomized participants.|||percent change in lesion count||Standard Error|Least Squares Mean
2587341|NCT02320149|Secondary|Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 6|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 6|ITT population included all randomized participants.|||percent change in lesion count||Standard Error|Least Squares Mean
2587342|NCT02320149|Secondary|Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 9|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 9|ITT population included all randomized participants.|||percent change in lesion count||Standard Error|Least Squares Mean
2587343|NCT02320149|Secondary|Percent Change From Baseline in Facial Inflammatory Lesion Counts at Week 12|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on ANCOVA model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 12|ITT population included all randomized participants.|||percent change in lesion count||Standard Error|Least Squares Mean
2587344|NCT02320149|Primary|Percentage of Participants With Investigator Global Assement (IGA) Success at Week 12|The investigator assessed the participant's inflammatory lesions on the face using the IGA 5-point scale. The scale ranges from 0 (best): clear, no evidence of papules or pustules to 4 (worst): severe, inflammatory lesions are more apparent, many papules/pustules, there may or may not be a few nodulocytic lesions. Success was defined as at least a 2-point decrease (improvement) from Baseline on the IGA assessment as well as a score of clear (0) or almost clear (1). The percentage of participants who achieved success is reported.|Baseline (Day 1) to Week 12|ITT population included all randomized participants.|||percentage of participants|||Number
2587345|NCT02320149|Primary|Absolute Change in Facial Inflammatory Lesion Counts at Week 12|Facial area lesion counts were made at the forehead, left and right cheeks, nose, and chin at baseline and at each treatment period visit. Inflammatory lesion counts were based on the following definitions: papule: a solid, elevated lesion < 0.5 centimeter (cm) in diameter (by inspection) with surrounding erythematous halo; pustule: an elevated lesion containing pus < 0.5 cm in diameter (by inspection) with surrounding erythematous halo; nodule: palpable solid erythematous lesion > 0.5 cm in diameter (by inspection); has depth, not necessarily elevated. A negative change from Baseline indicates that the number of inflammatory lesions decreased. Analyses were based on Analysis of Covariance (ANCOVA) model for the endpoint with treatment group and pooled study center as factors and baseline value as a covariate.|Baseline (Day 1) to Week 12|ITT population included all randomized participants.|||lesion count||Standard Error|Least Squares Mean
2587346|NCT02319967|Secondary|Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received a Follow-up Appointment Scheduled by ED Staff|Count of participants who were provided documented discharge instructions for a follow-up appointment scheduled within 4 weeks of discharge|At index ED discharge||||Participants|||Count of Participants
2587347|NCT02319967|Secondary|Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Rescue Medication|Count of participants who were provided documented discharge instructions to use an inhaled rescue medication|At index ED discharge||||Participants|||Count of Participants
2587348|NCT02319967|Secondary|Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Corticosteroids or Other Controller|Count of participants who were provided documented discharge instructions to use inhaled corticosteroids or other controller|At index ED discharge||||Participants|||Count of Participants
2587349|NCT02319967|Secondary|Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Systemic Corticosteroids|Count of participants who were provided documented discharge instructions to use systemic corticosteroids|At index ED discharge||||Participants|||Count of Participants
2587353|NCT02319967|Secondary|Number of Participants With All-cause Hospitalizations|Count of participants (children) with at least one all-cause hospitalization at 6 months|6 months post index ED discharge||||Participants|||Count of Participants
2587355|NCT02319967|Secondary|Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)|"The overall score is the mean score across all 13 items. Each item is scored on a 7-point Likert scale with 1 indicating severe impairment and 7 indicating no impairment. Higher scores indicate better quality of life; lower scores indicate worse quality of life.~Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ): Min possible score: 1; Max possible score: 7 Possible range for change in score is [-6 to 6]~The reported value represents a change in overall score from baseline to 6 months after index ED discharge.~A negative change in score indicates worsening quality of life. A positive change in score indicates improvement in quality of life. A score of 0 indicates no change."|Baseline and 6 months after index ED discharge|The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.|||score||Inter-Quartile Range|Median
2587356|NCT02319967|Secondary|PROMIS Sleep Disturbance (v1.0, SF4a)|"Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less sleep disturbance; high scores indicate more sleep disturbance.~PROMIS Sleep Disturbance (v1.0, SF4a): Min possible T-score: 32.0; Max possible T-score: 73.3 Possible range for change in T-score is [-41.3 to 41.3]~The reported value represents a change in T-score from baseline to 6 months after index ED discharge.~A negative change in score indicates improvement in sleep disturbance (i.e., less sleep disturbance). A positive change in score indicates worsening of sleep disturbance (i.e., more sleep disturbance). A score of 0 indicates no change."|Baseline and 6 months after index ED discharge|The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.|||T-score||Inter-Quartile Range|Median
2587357|NCT02319967|Secondary|PROMIS Fatigue (v1.0, SF4a)|"Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less fatigue; high scores indicate more fatigue.~PROMIS Fatigue: Min possible T-score: 33.7; Max possible T-score: 75.8 Possible range for change in T-score is [-42.1 to 42.1]~The reported value represents a change in T-score from baseline to 6 months after index ED discharge.~A negative change in score indicates improvement in fatigue (i.e., less fatigue). A positive change in score indicates worsening of fatigue (i.e., more fatigue). A score of 0 indicates no change."|Baseline and 6 months after index ED discharge|The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.|||T-score||Inter-Quartile Range|Median
2587358|NCT02319967|Secondary|PROMIS Depression (v1.0, SF4a)|"Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less depression; high scores indicate more depression.~PROMIS Depression: Min possible T-score: 41.0; Max possible T-score: 79.4 Possible range for change in T-score is [-38.4 to 38.4]~The reported value represents a change in T-score from baseline to 6 months after index ED discharge.~A negative change in score indicates improvement in depression. A positive change in score indicates worsening of depression. A score of 0 indicates no change."|Baseline and 6 months after index ED discharge|The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.|||T-score||Inter-Quartile Range|Median
2587359|NCT02319967|Secondary|PROMIS Anxiety (v1.0, SF4a)|"Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less anxiety; high scores indicate more anxiety.~PROMIS Anxiety: Min possible T-score: 40.3; Max possible T-score: 81.6 Possible range for change in T-score is [-41.3 to 41.3]~The reported value represents a change in T-score from baseline to 6 months after index ED discharge.~A negative change in score indicates improvement in anxiety. A positive change in score indicates worsening of anxiety. A score of 0 indicates no change."|Baseline and 6 months after index ED discharge|The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.|||T-score||Inter-Quartile Range|Median
2587360|NCT02319967|Secondary|Childhood Asthma Control Test (cACT)|"The scores of each item were summed for a total score (0-27) to measure change from index to 6-month primary endpoint. Low scores indicate worse asthma; high scores indicate better asthma.~Childhood Asthma Control Test (cACT): Min possible score: 0; Max possible score: 27 Possible range for change in score is [-27 to 27]~The reported value represents a change in score from baseline to 6 months after index ED discharge.~A negative change in score indicates improvement in asthma. A positive change in score indicates worsening of asthma. A score of 0 indicates no change."|Baseline and 6 months after index ED discharge|The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.|||score||Inter-Quartile Range|Median
2587361|NCT02319967|Primary|PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a)|"Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less satisfaction among caregivers; high scores indicate more satisfaction among caregivers.~PROMIS Satisfaction With Participation in Social Roles: Min possible T-score: 29.0; Max possible T-score: 64.1 Possible range for change in T-score is [-35.1 to 35.1]~The reported value represents a change in T-score from baseline to 6 months after index ED discharge.~A negative change in score indicates less satisfaction among caregivers. A positive change in score indicates a more satisfaction among caregivers. A score of 0 indicates no change."|Baseline and 6 months after index ED discharge|The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.|||T-score||Inter-Quartile Range|Median
2587362|NCT02319967|Primary|PROMIS Asthma Impact Scale (v1.0, SF8a)|"Raw scores (0-32) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate better asthma; high scores indicate worse asthma.~PROMIS Asthma Impact Scale, Pediatric: Min possible T-score: 31.5; Max possible T-score: 76.2 Possible range for change in T-score is [-44.7 to 44.7]~PROMIS Asthma Impact Scale, Parent proxy: Min possible T-score: 32; Max possible T-score: 80 Possible range for change in T-score is [-48 to 48]~The reported value represents a change in T-score from baseline to 6 months after index ED discharge.~A negative change in score indicates improvement in asthma. A positive change in score indicates worsening of asthma. A score of 0 indicates no change."|Baseline and 6 months after index ED discharge|The number of participants analyzed refers to the number of participants with evaluable data at baseline and 6 months after index ED discharge. The number of participants included in the analysis may not match the total number of participants enrolled as we were unable to obtain outcome data from some participants.|||T-score||Inter-Quartile Range|Median
2587363|NCT02319824|Secondary|Transferred NY-ESO-1-specific T Cells Based on Flow Cytometry Using Major Histocompatibility Complex Tetramers|Over 5% tet+ cells at 6 weeks? Patients may have detectable NY-ESO-1 specific T cells by MHC tetramers but if they are less than 5% this will be considered negative.|Up to 6 weeks post-treatment||||Participants|||Count of Participants
2587364|NCT02319824|Secondary|T Cell Transfer Based on Response Evaluation Criteria In Solid Tumors v1.1|RECIST at 6 weeks after treatment (non-radiated tumors only)|At 6 weeks post-treatment||||Participants|||Count of Participants
2587365|NCT02319824|Primary|Incidence of Adverse Events Measured by the National Cancer Institute Common Terminology Criteria for Adverse Events Version (v)4.03|CTCAE v4.03|Up to 12 weeks post-treatment|treated patients|||participants|||Number
2587366|NCT02319668|Secondary|Total Number of Recoverable Viable Bacteria in the Aerosol Generated During Dental Prophylaxis|Thick settle blood agar plates (supplemented with 5% [volume by volume v/v]) defibrinated horse blood) were used to determine the bacterial load of the aerosol. Thirty (30) minutes prior to the participants had their procedure (dental prophylaxis), a total of 5 settle plates with lids removed were placed at set positions around the dental surgery. After 30 minutes, the settle plates lids were replaced. This was repeated during the dental prophylaxis procedure using 5 fresh settle plates. All plates were then sealed with parafilm and transported for incubation in an anaerobic chamber at 37°C for 3 days. The plates were inspected daily to access growth and after 3 days removed and stored at 4°C for subsequent colony enumeration and Colony Forming Unit/mL (CFU/mL) calculation|At Baseline|ITT (N=38) defined as all the participants who were randomised, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||log (10) CFU/mL||Standard Deviation|Mean
2587367|NCT02319668|Secondary|Area Under the Curve (AUC) for the Total Number of Plaque Bacteria in the Mouth Post Implant Surgery|The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. The AUC of the total count of detectable plaque bacteria was calculated using trapezoidal rule in the time range from immediately post implant surgery to 7 days post implant surgery|Up to 7 days post implant surgery|ITT (N=38) defined as all the participants who were randomised, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||log (10) CFE × Day||Standard Deviation|Mean
2587368|NCT02319668|Secondary|Total Number of Detectable Plaque Bacteria Sampled at Implant Surgery (at Pre-rinse, Pre, Mid and Post Implant Surgery) and Post Implant Surgery (at Day 1 and 7)|The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample.|At Day 0 (pre-rinse, pre, mid and post implant surgery), Day 1 and 7|ITT (N=38) defined as all the participants who were randomised, received the study treatment at least once and provided at least one post-baseline assessment of efficacy. n was number of participants evaluated at specific endpoint.|||log (10) CFE||Standard Deviation|Mean
2587369|NCT02319668|Primary|Total Number of Detectable Plaque Bacteria Sampled 3 Days Post Implant Surgery|The examiner identified three plaque sampling sites as follows: surgical site, contralateral site to the surgical site and tongue. An individual cotton swab was used at each identified site for up to 20 seconds in order to harvest a plaque sample and immediately be placed into 1mL phosphate buffered saline in a sterile Eppendorf tube. The samples were analysed using quantitative polymerase chain reaction (qPCR) which determined the total number of bacteria in a sample by quantifying the number of 16S ribosomal ribonucleic acid (rRNA) genes in the sample. The number of bacteria in each of the three identified plaque sampling sites (surgical site, contralateral site to the surgical site and tongue) for each participant were summed to calculate the total number of bacteria for each participant.|At Day 3|Intent to treat (ITT) population (N=38): defined as all the participants who were randomised, received the study treatment at least once and provided at least one post-baseline assessment of efficacy.|||log(10) colony forming equivalents (CFE)||Standard Deviation|Mean
2587370|NCT02319642|Secondary|Change From Baseline Value in Health Assessment Questionnaire-Disability Index (HAQ-DI)|"Each subject will complete the HAQ-DI questionnaire at the visit and provides an assessment of the impact of the disease and its treatment on physical function. HAQ-DI scores range from 0 to 3. Lower scores indicate less disability.~Negative values indicate improvement from Baseline. Baseline refers to RA0044 baseline."|Week 24|Safety Set with last observation carried forward (LOCF). Only subjects with available data are included in the analysis of this Outcome Measure.|||units on a scale||Standard Deviation|Mean
2587394|NCT02319148|Secondary|Number of Participants Who Used at Least 1 Concomitant Medication|Participants were to abstain from all concomitant treatments, except for the treatment of AEs. Treatments taken after the first dose of study treatment were documented as concomitant treatments.|Baseline up to Day 15 (final study evaluation)|The safety analysis population included all participants who received the study medication.|||participants|||Number
2587371|NCT02319642|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 (ACR70) in Relation to Baseline|"The ACR70 represents improvement from Baseline of at least 70 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP).~Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study administration in RA0044."|Week 24|Safety Set with Non-Responder-Imputation (NRI).|||percentage of participants|||Number
2587372|NCT02319642|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 (ACR50) in Relation to Baseline|"The ACR50 represents improvement from Baseline of at least 50 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP).~Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study administration in RA0044."|Week 24|Safety Set with Non-Responder-Imputation (NRI).|||percentage of participants|||Number
2587373|NCT02319642|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 (ACR20) in Relation to Baseline|"The ACR20 represents improvement from Baseline of at least 20 %, calculated from assessments of tender joint count, swollen joint count, Patient's Assessment of Arthritis Pain (PtAAP) -visual analog scale (VAS), Patient's Global Assessment of Disease Activity (PtGADA) -VAS, Physician's Global Assessment of Disease Activity (PhGADA) -VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and C-reactive protein (CRP).~Responder was relative to baseline of RA0044. Baseline value in RA0044 was defined as the last non-missing measurement collected prior to first study drug administration in RA0044."|Week 24|Safety Set with Non-Responder-Imputation (NRI).|||percentage of participants|||Number
2587374|NCT02319642|Primary|Percentage of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE)|Treatment emergent SAEs are defined as SAEs starting on or after the date of first study medication administration in this OLE study up to 70 days post-last dose.|Baseline to the end of observation period (32 weeks)|Safety Set|||percentage of participants|||Number
2587375|NCT02319642|Primary|Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE)|TEAEs are defined as Adverse Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose.|Baseline to the end of observation period (32 weeks)|Safety Set|||percentage of participants|||Number
2587376|NCT02319642|Primary|Percentage of Subjects That Withdrew Due to a Treatment-emergent Adverse Event (TEAE)|TEAEs are defined as Advere Events (AEs) starting on or after the date of first study medication administration in this Open-label Extension (OLE) study up to 70 days post-last dose.|Baseline to the end of observation period (32 weeks)|Safety Set|||percentage of participants|||Number
2587377|NCT02319525|Secondary|Feasibility (Number of Participants Rating the Feasibility of Using Decision-aid or Pamphlet- Referred to as Education Guide in This Statement)|"Feasibility of the decision-aid vs. pamphlet was assessed using a single statement The education guide was easy to use. Patients rated this on 5-point ordinal scale ranging from strongly agree to strongly disagree (response options were: strongly agree, agree, neither agree nor disagree, disagree, strongly disagree). The number of patients was compared between the two treatment arms."|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)|One patient from pamphlet group did not respond to this question, therefore valid responses from pamphlet were 146, not 147|||Participants|||Count of Participants
2587378|NCT02319525|Secondary|"Acceptability (Number of Participants Rating Each Statement as Excellent)"|"Acceptability of the decision-aid (information quality and quantity, presentation style and usefulness) was assessed using a validated acceptability survey on 4-point scale ranging from excellent to poor (response options were: excellent, good, fair and poor). The number of patients rating each of the five statements as excellent (vs. other ratings) was compared between the two treatment arms."|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)||||Participants|||Count of Participants
2587379|NCT02319525|Secondary|Analysis of Audiotaped Physician-patient Interaction (Using the Active Patient Participation Coding Scheme (APPC)): Doctor Patient-centered Communication|This was done by analyzing the audio-recorded patient-physician discussion in patients with current lupus nephritis flare. The APCC is a validated instrument to measure 'active patient participation.' APCC assesses indicators and facilitators of patient participation. The unit of coding is the utterance, the oral analogue of a sentence. The range is 0 to unlimited. Patient participation is measured by the number of questions, number of concerns expressed, and act of assertiveness (e.g., preferences, introducing topics, making requests). These are 'active' forms of participation because of their influence on clinician behavior and the structure and content of the consultation. The APPC also assess clinician behaviors that facilitate and support patient participation, partnership-building and supportive talk (e.g., reassurance, empathy). We present doctor patient-centered communication. higher scores indicates better patient participation and communication.|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)|Only participants having a current lupus nephritis and requiring immunosuppressive medication change/initiation or participants with newly diagnosed lupus nephritis starting an immunosuppressive medication, who also agreed for an audio-recorded conversation.|||units on a scale||Standard Deviation|Mean
2587380|NCT02319525|Secondary|Patient Physician Communication (Interpersonal Processes of Care (IPC)|This was assessed using the interpersonal processes of care (IPC), an 18-item validated patient-reported measure of patient-physician communication and care processes. The score ranges from 18 (worst) to 90 (best) and the scale is a patient-reported measure of patient-physician communication and care processes.|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) (usually within 1 week)|All participants who received either the Decision Aid or Pamphlet.|||units on a scale||Standard Deviation|Mean
2587431|NCT02318979|Secondary|Top Speed|The investigators will measure the top sprinting speed to determine the optimal prosthesis for each participant.|4-10 days|Fastest top speed for a running-specific prosthetic configuration.|||m/s||Standard Deviation|Mean
2587381|NCT02319525|Secondary|Control Preferences Scale: Patient Participation in Decision-making|This scale assessed how much decision-making control they would like to have versus actually experienced. There are 5 responses for 5 control options: active, active shared, collaborative, passive shared and passive, which were collapsed into active (active, active shared), collaborative, and passive (passive shared and passive), as previously (and pre-specified). Concordance was assessed between desired and actual role played by each patient. We present these data for patients with current flare only, since only they were making a decision about the immunosuppressive drugs; patients with past lupus flare were not included in the denominator.|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week)|Only participants having a current lupus nephritis and requiring immunosuppressive medication change/initiation or participants with newly diagnosed lupus nephritis starting an immunosuppressive medication.|||participants|||Number
2587382|NCT02319525|Primary|Informed Choice (Validated Instruments for Values Regarding Immunosuppressives, Knowledge About Immunosuppressives, and Treatment Decision-making)|Concordance between values related (for or against starting) immunosuppressive drugs with patients' decision (to start or not start) immunosuppressive drugs, in those with adequate knowledge about benefits/harms of immunosuppressive drugs, assessed using validated instruments for values regarding immunosuppressive drugs, knowledge about immunosuppressive drugs, and treatment decision-making (patient's decision to start immunosuppressive drug).|After viewing the guide or standard hand-out on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week)|All participants who received either the Decision Aid or Pamphlet.|||participants|||Number
2587383|NCT02319525|Primary|Change From Baseline in Decisional Conflict Scale Scores|Patient self-administered, validated measure of decisional conflict, most commonly used as the primary outcome in RCTs of decision aids (change score). The score ranges from 0 (no decisional conflict) to 100 (extreme decisional conflict). Decisional conflict represents a state of uncertainty about a choice or course of action and is more likely in situations involving high-stakes choices with important potential gains and losses, value tradeoffs in selecting a choice or a course of action (vs. the alternative) or uncertain outcomes.|Baseline and after viewing the decision-aid or the standard hand-out (pamphlet) on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week)|All participants who received either the Decision Aid or Pamphlet|||units on a scale||Standard Deviation|Mean
2587384|NCT02319486|Primary|Event Free Survival Rate|measure the event free survival rate for the patients at 18 months: patients that without tumor relapse or metastasis|18 months||||participants|||Number
2587385|NCT02319317|Secondary|Driving Citations and Crashes|Difference between the intervention and control group on driving citations and crashes.|Baseline (Study Visit 1) through Study Visit 4 (around 6 months).|||||||
2587386|NCT02319317|Secondary|Self-report Driving Behaviors|Difference between the intervention and control group on self-report measures of driving behaviors.|Baseline (Study Visit 1) through Study Visit 4 (around 6 months).|||||||
2587387|NCT02319317|Secondary|Simulated Driving Performance|Difference between the intervention and control group on the simulated driving assessment (measures of driving performance during the simulated experimental drives).|Baseline (Study Visit 1) through Study Visit 3|||||||
2587388|NCT02319317|Secondary|Adherence|Adherence among the intervention and control group to the intervention.|Baseline (Study Visit 1) through completion of the intervention.|||||||
2587389|NCT02319317|Secondary|Proportion of Participants Randomized|Proportion of participants screened, enrolled and randomized|Baseline (Study Visit 1)|||||||
2587390|NCT02319317|Primary|Retention of Participants|Number of participants enrolled who complete Study Visit 1, Study Visit 2, Study Visit 3 and Study Visit 4.|Baseline (Study Visit 1) through Study Visit 4 (around 6 months).||||Participants|||Count of Participants
2587391|NCT02319174|Primary|Percent of Sphygmo Readings That Were Within 5mmHg, 10mmHg, and 15mmHg of the Readings by the Gold Standard Sphygmomanometer.|"The British Hypertension society defines a specific criteria for the accuracy of a sphygmomanometer. Devices are graded according to the cumulative percentage of readings that have an absolute difference between the more favorable observer's mercury sphygmomanometer readings and the test device of < 5 mmHg, < 10 mmHg, and < 15 mmHg. A letter grade of A requires that over 60%, 85%, and 95% were achieved in the < 5 mmHg, < 10 mmHg, and <15 mmHg categories, respectively. A letter grade of B requires that over 50%, 75%, and 90% were achieved in the < 5 mmHg, < 10 mmHg, and <15 mmHg categories, respectively. The test device achieved a grade of (A/A) with the validation data from this study."|Blood pressure was measured an average of 9 times for each participant during their single measurement period, and the average of those measurements was recorded. Each measurement period lasted approximately 30-45 minutes|Of 41 participants who completed the study, 5 participants were excluded on account of the observer reporting a difficulty in hearing, movement, or uncertainty with the measurement. This left 36 participants, 18 of which were used to train the device. The data presented here is from the remaining 18 participants.|||percentage of measurements in range|||Number
2587392|NCT02319174|Primary|Accuracy of Blood Pressure Readings by Sphygmo|Mean difference of systolic and diastolic blood pressures between Sphygmo blood pressure measurements and measurements from the gold standard sphygmomanometer.|Blood pressure was measured an average of 9 times for each participant and the average of these measurements was recorded. Each measurement period lasted approximately 30-45 minutes|Of 41 participants who completed the study, 5 participants were excluded on account of the observer reporting a difficulty in hearing, movement, or uncertainty with the measurement. This left 36 participants, 18 of which were used to train the device. The data presented here is from the remaining 18 participants.|||mmHg||Standard Deviation|Mean
2587393|NCT02319148|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last study drug administration|The safety analysis population included all participants who received the study medication.|||participants|||Number
2587395|NCT02319148|Secondary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (>=)300 milliseconds (msec) or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (≤)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); and QTcF >=450 msec or >=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Pre-dose (Periods 1 and 2), 4, 72 and 96 hours post-dose in Period 2|The safety analysis population included all participants who received the study medication; n=number of participants evaluated against criteria.|||participants|||Number
2587396|NCT02319148|Secondary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of >=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mm Hg.|Baseline up to Day 9|The safety analysis population included all participants who received the study medication; n=number of participants evaluated against criteria.|||participants|||Number
2587397|NCT02319148|Secondary|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (coagulation panel, circulating immune complex, and complement activation).|Baseline up to 28 days after last study drug administration|The safety analysis population included all participants who received the study medication.|||participants|||Number
2587398|NCT02319148|Secondary|Terminal Elimination Half-Life (t1/2) of PF-00489791|t1/2 is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hour||Standard Deviation|Mean
2587399|NCT02319148|Secondary|Apparent Oral Clearance (CL/F) of PF-00489791|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
2587400|NCT02319148|Secondary|Apparent Volume of Distribution (Vz/F) of PF-00489791|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||liter||Geometric Coefficient of Variation|Geometric Mean
2587401|NCT02319148|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-00489791||Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hour||Full Range|Median
2587402|NCT02319148|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-00489791|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng.hr/mL||Geometric Coefficient of Variation|Geometric Mean
2587403|NCT02319148|Primary|Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-00489791|AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2587404|NCT02319148|Primary|Maximum Observed Plasma Concentration (Cmax) of PF-00489791||Pre-dose, 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after PF-00489791 administration|The pharmacokinetic (PK) analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2587405|NCT02319044|Secondary|Duration of Response|Duration of objective response in patients with objective response based on BICR assessments according to RECIST v1.1. Duration of response was the time from the first documentation of Complete response/Partial response (which was subsequently confirmed) until the date of progression, death, or the last evaluable RECIST assessment for patients that did not progress. An ongoing response was defined as a patient who had documented objective response and was still alive and progression-free at the time of the data cut-off (per RECIST v1.1 as assessed by BICR).|After 12 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease|||Participants|||Number
2588899|NCT02299869|Primary|Comfort Preference|Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference|20 minutes||||participants|||Number
2587406|NCT02319044|Secondary|Quality of Life|Improvement in quality of life was assessed using European Organisation for Research and Treatment of Cancer (EORTC) questionnaires: -The impact of treatment on Health-Related Quality of Life, functioning, and symptoms was evaluated using the EORTC QLQ-C30 v3. -Head and neck cancer-specific symptoms were evaluated using the EORTC QLQ-H&N35. The symptom and QoL/function improvement rate was defined as the number (%) of patients with 2 consecutive assessments at least 14 days apart that showed a clinically meaningful improvement (a decrease from baseline score ≥10 or EORTC QLQ-C30 scales) in that symptom/function from baseline. For QLQ-H&N35A a minimum clinically meaningful change was defined as a change in the score from baseline of >10 for scales/items|After 12 months|Full analysis set - all randomized patients|||% patients||95% Confidence Interval|Number
2587407|NCT02319044|Secondary|Overall Survival|Survival status at time of overall survival analysis. 'Still in survival follow-up' includes patients known to be alive at data cut-off. 'Terminated prior to death' includes patients with unknown survival status or patients who were lost to follow-up.|After 12 months|Full analysis set - all randomized patients|||% participants|||Number
2587408|NCT02319044|Secondary|Progression-free Survival (PFS)|Progression status at 12 months based on BICR assessments according to RECIST v1.1 at time of Progression Free Survival (PFS) analysis. Progression was defined as the time from the data of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to progression. -Target Lesions, Non Target Lesions and New Lesions are not necessarily mutually exclusive categories. -Progression death refers to death in the absence of RECIST 1.1 progression.|After 12 months|Full analysis set - all randomized patients|||% participants|||Number
2587409|NCT02319044|Secondary|Progression-free Survival (PFS)|Progression status at 6 months based on BICR assessments according to RECIST v1.1 at time of Progression Free Survival (PFS) analysis. Progression was defined as the time from the data of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to progression. -Target Lesions, Non Target Lesions and New Lesions are not necessarily mutually exclusive categories. -Progression death refers to death in the absence of RECIST 1.1 progression.|After 6 months|Full analysis set - all randomized patients|||% participants|||Number
2587410|NCT02319044|Secondary|Disease Control Rate (DCR)|Disease control rate (DCR) at 12 months based on BICR assessments according to RECIST v1.1. DCR at 6 months was evaluated using 2 different approaches to the length of stable disease (SD). -Method 1: Patients who had a best objective response of complete response (CR) or partial response (PR) within 24 weeks or had demonstrated SD for a minimum interval of 24 weeks following randomization. -Method 2: Patients who had a best objective response of CR or PR in the first 24 weeks or who had demonstrated SD for a minimum interval of 16 weeks following randomization.|After 12 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease|||% participants|||Number
2587411|NCT02319044|Secondary|Disease Control Rate (DCR)|Disease control rate (DCR) at 6 months based on BICR assessments according to RECIST v1.1. DCR at 6 months was evaluated using 2 different approaches to the length of stable disease (SD). -Method 1: Patients who had a best objective response of complete response (CR) or partial response (PR) within 24 weeks or had demonstrated SD for a minimum interval of 24 weeks following randomization. -Method 2: Patients who had a best objective response of CR or PR in the first 24 weeks or who had demonstrated SD for a minimum interval of 16 weeks following randomization.|After 6 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease|||% participants|||Number
2587412|NCT02319044|Secondary|Time to Onset of Response From First Dose|Time to onset of response in patients with objective response based on BICR assessments according to RECIST 1.1|After 12 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease|||Months||Full Range|Median
2587413|NCT02319044|Secondary|Time to Response|Time to response in patients with objective response based on BICR assessments according to RECIST 1.1|After 12 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease|||% participants|||Number
2587414|NCT02319044|Secondary|Duration of Response - Participants Remaining in Response|Participants remaining in response - based on BICR assessments according to RECIST v1.1. An ongoing response was defined as a patient who had documented objective response and was still alive and progression-free at the time of the data cut-off.|After 12 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease|||% participants|||Number
2587415|NCT02319044|Secondary|Best Objective Response|The best response a patient has had during their time in the study|After 12 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease|||% participants|||Number
2587416|NCT02319044|Primary|Objective Response Rate at 12 Months|Objective response rate (per RECIST 1.1 as assessed by blinded independent central review [BICR]) is defined as the number (%) of patients with a confirmed complete response or confirmed partial response and will be based on all treated patients who are PD-L1-positive with measurable disease at baseline per BICR. Response Evaluation Criteria in Solid Tumors [RECIST] 1.1. criteria are: Complete response [CR] = disappearance of all target lesions since baseline; and partial response [PR] = at least a 30% decrease in the sum of the diameters of target lesions.|After 12 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease|||% participants||95% Confidence Interval|Number
2587417|NCT02319044|Primary|Objective Response Rate at 6 Months|Objective response rate, primary analysis, based on BICR assessments according to RECIST v1.1. The number (%) of patients with a response excludes unconfirmed responses|After 6 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease|||% participants||95% Confidence Interval|Number
2587433|NCT02318979|Primary|Biomechanics|The investigators will measure stance average vertical ground reaction forces during running and sprinting.|4-10 days|We hypothesized that prosthetic configurations would affect stance average vertical ground reaction forces.|||N/kg||Standard Deviation|Mean
2587418|NCT02319031|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), Grade 3 or Grade 4 (Grade 3/4) AEs, and Grade 3/4 Laboratory Abnormalities|Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. The degree of the adverse event or laboratory abnormality are evaluated by grades: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Grading as per using National Cancer Institute Common Terminology Criteria (NCI CTC) Version 3.0 criteria.|Date of First Dose of Study Drug to 7 Days post last dose of study drug (up to 13 weeks or 17 weeks depending on the randomized treatment group)|All treated participants: Enrolled participants who received at least 1 dose of study drug|||participants|||Number
2587419|NCT02319031|Secondary|Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 4 (SVR4) and Follow-up Week 24 (SVR24)|SVR4, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 4. SVR24, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 24. SVR4 imputation was based on Next Value Carried Backwards (NVCB) approach. SVR24 imputation was based on missing being treated as non-responder. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.|Follow-up Weeks 4 and 24|All treated participants: Enrolled participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2587420|NCT02319031|Primary|Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12)|SVR12, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 12. SVR12 imputation was based on Next Value Carried Backwards (NVCB) approach. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.|Follow-up Week 12|All treated participants: Enrolled participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2587421|NCT02319005|Secondary|All-cause Mortality|Total number of deaths in the placebo group compared to the revusiran (ALN-TTRSC) treatment group|18 months|Study drug was discontinued early due to an imbalance in mortality observed between patients treated with revusiran and placebo. No patients had an 18-month visit, therefore, the endpoints cannot be calculated as data were not collected.||||||
2587422|NCT02319005|Secondary|Cardiovascular (CV) Hospitalization|Number of cardiovascular-related hospitalizations in the placebo group compared to the revusiran (ALN-TTRSC) treatment group|18 months|Study drug was discontinued early due to an imbalance in mortality observed between patients treated with revusiran and placebo. No patients had an 18-month visit, therefore, the endpoints cannot be calculated as data were not collected.||||||
2587423|NCT02319005|Secondary|Cardiovascular (CV) Mortality|Number of cardiovascular-related deaths in the placebo group compared to the revusiran (ALN-TTRSC) treatment group|18 months|Study drug was discontinued early due to an imbalance in mortality observed between patients treated with revusiran and placebo. No patients had an 18-month visit, therefore, the endpoints cannot be calculated as data were not collected.||||||
2587424|NCT02319005|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ)|The difference between revusiran (ALN-TTRSC) and placebo group in the change from Baseline to 18 months in the Kansas City Cardiomyopathy Questionnaire|18 months|Study drug was discontinued early due to an imbalance in mortality observed between patients treated with revusiran and placebo. No patients had an 18-month visit, therefore, the endpoints cannot be calculated as data were not collected.||||||
2587425|NCT02319005|Secondary|New York Heart Association (NYHA) Class|The difference between revusiran (ALN-TTRSC) and placebo group in the change from baseline to 18 months in the NYHA class|18 months|Study drug was discontinued early due to an imbalance in mortality observed between patients treated with revusiran and placebo. No patients had an 18-month visit, therefore, the endpoints cannot be calculated as data were not collected.||||||
2587426|NCT02319005|Secondary|Composite Cardiovascular (CV) Mortality and Cardiovascular (CV) Hospitalization|Number of cardiovascular-related deaths and cardiovascular-related hospitalizations in the placebo group compared to the revusiran (ALN-TTRSC) treatment group|18 months|Study drug was discontinued early due to an imbalance in mortality observed between patients treated with revusiran and placebo. No patients had an 18-month visit, therefore, the endpoints cannot be calculated as data were not collected.||||||
2587427|NCT02319005|Primary|Serum TTR Levels|The difference between revusiran (ALN-TTRSC) and placebo group in the percent reduction in serum TTR levels over 18 months|18 months|Study drug was discontinued early due to an imbalance in mortality observed between patients treated with revusiran and placebo. No patients had an 18-month visit, therefore, the endpoints cannot be calculated as data were not collected.||||||
2587428|NCT02319005|Primary|6 Minute Walk Distance (6-MWD)|The difference between revusiran and placebo group in change from baseline to 18 months in the total distance walked in 6 minutes|18 months|Study drug was discontinued early due to an imbalance in mortality observed between patients treated with revusiran and placebo. No patients had an 18-month visit, therefore, the endpoints cannot be calculated as data were not collected.||||||
2587429|NCT02318992|Secondary|Number of Participants Who Had a Subsequent Bout of C-diff Associated Diarrhea|a subsequent bout of C-diff associated diarrhea was defined as diarrhea, C. difficile toxins positive and using anti-C. difficile antibiotic treatment|30 days|One subject in the Fecal Microbiota_Fresh group was lost to follow up.|||Participants|||Count of Participants
2587430|NCT02318992|Primary|Safety of Fresh, Frozen or Lyophilized Intestinal Bacteria From Healthy Donors Given by Colonoscopy for Therapy in Subjects With Recurrent C. Difficile Associated Diarrhea (RCDAD) as Assessed by Number of Participants Who Any Adverse Event|Any untoward medical occurrence associated with the use of PRIM-DJ2727 whether or not considered drug related is considered as an adverse event (AE)|6 months|One subject in the Fecal Microbiota_Fresh group was lost to follow up.|||Participants|||Count of Participants
2587438|NCT02318901|Secondary|Textural Changes Identified on Imaging That is Done Per Routine Practice|PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.|12 weeks|No data was analyzed for this trial. PI left site unexpectedly.||||||
2587439|NCT02318901|Secondary|To Characterize Changes in Circulating Tumor DNA in Patients Enrolled on This Study|PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.|up to 12 months|No data was analyzed for this trial. PI left site unexpectedly.||||||
2587440|NCT02318901|Secondary|To Determine the Overall Survival (OS) and Progression-free Survival (PFS)|PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.|up to 12 months|No data was analyzed for this trial. PI left site unexpectedly.||||||
2587441|NCT02318901|Secondary|Response Rate by irRC and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria|PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.|12 weeks|No data was analyzed for this trial. PI left site unexpectedly.||||||
2587442|NCT02318901|Secondary|Frequency of Grade 3 or Higher Treatment-related Adverse Events by CTCAE 4.03|PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.|up to 12 months|No data was analyzed for this trial. PI left site unexpectedly.||||||
2587443|NCT02318901|Primary|Determine the Recommended Phase 2 Dose (RP2D) of Monoclonal Antibody Therapy (Mab) in Combination With Pembrolizumab (Pembro) in Subjects With Advanced Cancer|PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.|3 weeks|PI left site. Study was prematurely terminated. No additional study items were conducted including, data collection, results or statistical analysis completed.||||||
2587444|NCT02318797|Secondary|Change in Lab Monitoring - EKG|Frequency of EKG tests in 12 month periods|Updated annually using claims data over 2 year active intervention period|Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point|||frequency of EKG tests in 12 mo. period||Standard Deviation|Mean
2587445|NCT02318797|Secondary|Change in Lab Monitoring - Lipids|Frequency of lipid lab tests in 12 month periods|Updated annually using claims data over 2 year active intervention period|Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point|||frequency of lab tests in 12 mo. period||Standard Deviation|Mean
2587446|NCT02318797|Secondary|Change in Lab Monitoring - Glucose|Frequency of glucose lab tests in 12 month periods|Updated annually using claims data over 2 year active intervention period|Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point|||frequency of lab tests in 12 mo. period||Standard Deviation|Mean
2587447|NCT02318797|Secondary|Change in Medication Adherence - Antidepressants|Claims data used to calculate antidepressant medication possession ratio (MPR) for participants in 6 month time periods. If the (first_fill - last_end_Date) > 180 then MPR = (total days supply - (first_fill - last_end_Date) - 180 ) / 180. If the total duration was not greater than 180 days, MPR = total days supply / 180.|Updated annually using claims data over 2 year active intervention period|The N for the time point with the greatest # of participants who were prescribed am antidepressant medication.|||Medication possession ratio||Standard Deviation|Mean
2587448|NCT02318797|Secondary|Change in Medication Adherence - Hypertension|Claims data used to calculate antihypertensive medication possession ratio (MPR) for participants in 6 month time periods. If the (first_fill - last_end_Date) > 180 then MPR = (total days supply - (first_fill - last_end_Date) - 180 ) / 180. If the total duration was not greater than 180 days, MPR = total days supply / 180.|Updated annually using claims data over 2 year active intervention period|The N for the time point with the greatest # of participants who were prescribed a antihypertensive medication.|||Medication possession ratio||Standard Deviation|Mean
2587449|NCT02318797|Secondary|Change in Medication Adherence - Antipsychotics|Claims data used to calculate antipsychotic medication possession ratio (MPR) for participants in 6 month time periods. If the (first_fill - last_end_Date) > 180 then MPR = (total days supply - (first_fill - last_end_Date) - 180 ) / 180. If the total duration was not greater than 180 days, MPR = total days supply / 180.|Updated annually using claims data over 2 year active intervention period|The N for the time point with the greatest # of participants who were prescribed a antipsychotic medication.|||Medication possession ratio||Standard Deviation|Mean
2587450|NCT02318797|Secondary|Change in Patient Satisfaction With Care|Change in patient satisfaction with care was assessed using the Patient Assessment of Care for Chronic Conditions (PACIC). Each item of the PACIC is on a 1 to 5 scale. The total score is the average of all 20 item scores. Higher scores represent increased frequency of structured chronic care.|Baseline and every 6 months over 2 year active intervention period|Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)|||Units on a scale||Standard Deviation|Mean
2587451|NCT02318797|Secondary|Change in Lab Monitoring - Overall|Frequency of lab tests (glucose, lipids, EKG) in 12 month periods|Updated annually using claims data over 2 year active intervention period|Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point|||frequency of lab tests in 12 mo. period||Standard Deviation|Mean
2587452|NCT02318797|Secondary|Change in Emergent Care Use (Claims Data)|Behavioral and physical health claims data will be obtained to determine frequency of emergent service use for participants over 12-month time periods.|Updated annually using claims data over 2 year active intervention period|# of individuals with 80% Medicaid eligibility in the 12 months prior to the data collection time point.|||frequency of visits in 12-month periods||Standard Deviation|Mean
2587462|NCT02318693|Secondary|Change From Baseline in 24-hour Mean Glucose Level|The mean glucose level over 24-hours at Baseline and Day 13 was determined using CGM values corrected for participant-administered finger-stick values. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.|||mg/dL||95% Confidence Interval|Least Squares Mean
2587453|NCT02318797|Secondary|Change in Functional Status (Sheehan Disability Scale)|Functional status is measured using the Sheehan Disability Scale which assesses functional impairment in three domains including: work/school, social and family life. Respondents rate the extent to which work/school, social life and home life or family responsibilities are impaired by symptoms. The three items from the Sheehan Disability Scale are summed together into a single measure of global functional impairment. This measure ranges from 0 to 30, with 0 being unimpaired and 30 being highly impaired.|Baseline and every 6 months over 2 year active intervention period|Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)|||Units on a scale||Standard Deviation|Mean
2587454|NCT02318797|Secondary|Change in Medication Adherence - Diabetes|Claims data used to calculate diabetes medication possession ratio (MPO) for participants diagnosed with diabetes in 6 month time periods. If the (first_fill - last_end_Date) > 180 then MPR = (total days supply - (first_fill - last_end_Date) - 180 ) / 180. If the total duration was not greater than 180 days, MPR = total days supply / 180.|Updated annually using claims data over 2 year active intervention period|The N for the time point with the greatest # of participants who were prescribed a diabetes medication.|||Medication possession ratio||Standard Deviation|Mean
2587455|NCT02318797|Secondary|Change in Quality of Life (QLESQ)|Patient quality of life is measured using the QLESQ (Quality of Life Enjoyment and Satisfaction Questionnaire) in which participants respond on a scale of 1 (very poor) to 5 (very good) their level of satisfaction with a variety of social and physical domains. The total raw score ranges from 14 to 70 or 0-100%. Only the first 14 items yield the raw total score as the last two items are standalone. The raw total score is transformed into a percentage maximum possible score using the following formula: (raw total score-minimum score)/(maximum possible raw score-minimum score). The lower values/percentages represent a poor outcome while higher values/percentages represent a better outcome. The information below reflects raw scores (rather than percentages).|Baseline and every 6 months over 2 year active intervention period|Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)|||Units on a scale||Standard Deviation|Mean
2587456|NCT02318797|Secondary|Change in Hope (Hope Scale)|"Assessed using the Hope Scale, an instrument designed to measure hope that has been previously used in health services research. Twelve items are rated on a four-point response scale ranging from definitely false to definitely true and summed to produce a total score. The hope scale ranges from 1 to 10, with 1 being no hope and 10 being filled with hope."|Baseline and every 6 months during the active intervention period|Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)|||Units on a scale||Standard Deviation|Mean
2587457|NCT02318797|Primary|Change in Health Status ( SF-12v2™): Mental Health Sub-scale|Health status is measured using the SF-12v2™, a widely used and practical health survey tool consisting of 12 questions and two sub-scales for measuring physical and mental health status and symptom effects and functioning. The mental health component summary score is created using a weighted sum of all 12 items and then a scoring algorithm places negative weights on four of the health domains and positive weights on the other four health domains (reverse of the weighting used for the physical health component summary score). Scores range from 0-100 and better mental health is indicated by a higher score.|Baseline and every 6 months during the active intervention period|Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)|||units on a scale||Standard Deviation|Mean
2587458|NCT02318797|Primary|Change in Engagement in Primary/Specialty Care|The frequency of primary/specialty care visits over two 12-month time periods.|Updated annually using claims data over 2 year active intervention period|Study participants who were Medicaid eligible for 80% of the year prior to the data collection time point|||Frequency of visits in 12-month periods||Standard Deviation|Mean
2587459|NCT02318797|Primary|Change in Health Status ( SF-12v2™): Physical Health Sub-scale|Health status is measured using the SF-12v2™, a widely used and practical health survey tool consisting of 12 questions and two sub-scales for measuring physical and mental health status and symptom effects and functioning. The physical health component summary score is created using a weighted sum of all 12 items and then a scoring algorithm places negative weights on four of the health domains and positive weights on the other four health domains. Scores range from 0-100 and better physical health is indicated by a higher score.|Baseline and every 6 months over 2 year active intervention period|Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)|||units on a scale||Standard Deviation|Mean
2587460|NCT02318797|Primary|Change in Patient Activation in Care (PAM, a 13-item Scale)|Assessed using the PAM, a 13-item scale that renders a total activation score. This measure gauges the knowledge, skills, and confidence of patients essential to managing their own health and health care. It divides into progressively higher levels of activation: starting to take a role, building knowledge and confidences, taking action, and maintaining behaviors. The raw score scale for the PAM ranges from 13 to 52. The activation scale for the PAM ranges from 0 to 100. The lower values represent a poor outcome while higher values represent a better outcome.|Baseline and every 6 months over 2 year active intervention period|Includes those who completed the measure at baseline and whose measure was able to be scored (ie. was not missing data which would have rendered it unusable in analysis)|||units on a scale||Standard Deviation|Mean
2587461|NCT02318693|Secondary|Change From Baseline in Percentage of Hypoglycemic Values (Glucose Sensor Readings: < 70, <60, <50 mg/dL)|Hypoglycemia, defined as low blood glucose, is a common side effect of medications used to treat diabetes mellitus type 2. The percentage of hypoglycemic corrected CGM readings (sensor glucose <70, <60, <50 mg/dL) over a 24-hour period were determined at baseline and Day 13. CGM values were corrected using a participant-administered finger-stick test for blood glucose. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from baseline to Day 13 indicates improvement in occurrence of hypoglycemia.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.|||Percent change||95% Confidence Interval|Least Squares Mean
2587463|NCT02318693|Secondary|Change From Baseline in Maximum Incremental Postprandial Glucose Levels in Each Meal|The peak postprandial glucose level during the 3 hours post meal minus the preprandial glucose level 1 hour before meal was determined for corrected CGM values at Baseline and Day 13 for breakfast, lunch, and dinner. Meals were standardized with respect to total calories, and protein, fat, and carbohydrate composition as well as timing of administration. CGM values were corrected using a participant-administered finger-stick test for blood glucose. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from baseline to Day 13 indicates better control of postprandial glucose.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.|||mg/dL||95% Confidence Interval|Least Squares Mean
2587464|NCT02318693|Secondary|Change From Baseline in the Standard Deviation of Blood Glucose Levels|SD is a popular metric for assessment of postprandial glucose swings. The SD of all glycemic excursions over 24 hours (i.e., total of 288 glucose values over 24 hours) was determined for Baseline and Day 13. Original values were obtained using CGM and corrected for blood glucose values obtained via participant-administered finger-stick. LS mean values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.|||mg/dL||95% Confidence Interval|Least Squares Mean
2587465|NCT02318693|Primary|Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) at Day 13|MAGE is a popular metric for assessment of major (e.g., postprandial) glucose swings. MAGE is calculated as the average of differences between consecutive glucose peaks and nadirs greater than 1 standard deviation (SD) of 24-hour mean glucose. In this assessment, glucose levels were determined using continuous glucose monitoring (CGM) over 24 hours at Baseline and Day 13; CGM values were further corrected for blood glucose values obtained via participant-administered finger-stick. Least squares (LS) means values were derived from a constrained longitudinal analysis model. A negative (-) change from Baseline to Day 13 indicates improvement of the assessed outcome.|Baseline (Day -2) and Day 13|The FAS population consisting of all randomized participants who received at least one dose of study treatment, with at least one post-randomization/post-treatment observation for the analysis, and with applicable baseline data was used for analysis.|||mg/dL||95% Confidence Interval|Least Squares Mean
2587466|NCT02318667|Secondary|Correlation of Endoscopic Mayo Subscore With Ulcerative Colitis Endoscopic Index Of Severity (UCEIS©) Overall Score at Week 6 and Week 16|UCEIS© is a 3-item (vascular pattern, bleeding and erosion/ulceration) validated tool for assessing endoscopic severity of UC. Each item has 3 or 4 levels of severity and is given a score. The scores for each individual item are combined into a total score ranging from 1 to 11. A higher score indicates increased endoscopic severity of UC. Moderate correlation was defined as rs coefficient between -0.5 to -0.3 or 0.3 to 0.5.|Week 6 and Week 16|Analysis population includes all participants who had received study medication and had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity, and UCEIS overall score at Week 6 and Week 16.|||rs coefficient||95% Confidence Interval|Number
2587467|NCT02318667|Secondary|Change From Baseline to Week 6 in ST2 Level According to Participant's Mayo Endoscopic Response at Week 16 (Maintained Response at Week 16 or Did Not Maintain Response at Week 16)|ST2, a serum biomarker, was collected at Baseline and Week 6. Comparison of participants who achieved endoscopic response [endoscopic Mayo subscore 0 or 1] at Week 6 and maintained response through Week 16 versus participants who did not maintain response throughout Week 16, regarding serum soluble ST2 at baseline, Week 6 and change between baseline and Week 6.|Baseline, Week 6|Analysis population includes all participants who had received study medication and achieved endoscopic response at Week 6.|||ng/mL||Standard Deviation|Mean
2587468|NCT02318667|Secondary|Change From Baseline to Week 6 in ST2 Levels in Participants With Active Versus Inactive UC|ST2, a serum biomarker, was collected at Baseline and Week 6. Active Ulcerative Colitis was defined as an endoscopic Mayo subscore ≥2 and inactive Ulcerative Colitis was defined as an endoscopic Mayo subscore of 0 or 1.|Baseline, Week 6|Analysis population includes all participants who had received study medication and had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity at Week 6.|||ng/mL||Standard Deviation|Mean
2587469|NCT02318667|Secondary|Correlation of Serum Soluble ST2 Levels With Clinical Activity (Assessed by Total Mayo Score) at Week 6 and Week 16|ST2, a serum biomarker, was collected at Week 6 and Week 16. The total Mayo Score, is a scale for assessing UC activity and is the sum of 4 subscores (assessment of stool frequency [0-3], rectal bleeding [0-3], Physician's Global Assessment [0-3], and endoscopic Mayo subscore [0-3]) and has values that range from 0 to 12. Clinical remission: ≤2 points with no individual subscore > 1; Mildly active disease: 3-5 points; Moderately active disease: 6-10 points; Severely active disease: 11-12 points. A higher score indicates more severe disease. Moderate correlation was defined as rs coefficient between -0.5 to -0.3 or 0.3 to 0.5.|Weeks 6 and 16|Analysis population includes all participants who had received study medication and had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity, and total Mayo score at Weeks 6 and 16.|||rs coefficient||95% Confidence Interval|Number
2587470|NCT02318667|Secondary|Correlation of Serum Soluble ST2 Levels With Faecal Calprotectin Levels at Baseline and Week 6 and Week 16|ST2 and faecal calprotectin, serum biomarkers, were collected at Week 6 and Week 16. Faecal calprotectin is a surrogate marker for the presence of intestinal inflammation and response to treatment in participants with Inflammatory Bowel Disease. Moderate correlation was defined as rs coefficient between -0.5 to -0.3 or 0.3 to 0.5.|Baseline, Weeks 6 and 16|Analysis population includes all participants who had received study medication and had a valid faecal calprotectin assessment at time point (Baseline, Week 6, and Week 16).|||rs coefficient||95% Confidence Interval|Number
2587581|NCT02316717|Other Pre-specified|Regulatory T Cells (FoxP3+ CD25-CD4+) in Peripheral Blood Mononuclear Cells|Change in percent of FoxP3+ CD25-CD4+ cells in Peripheral Blood Mononuclear Cells|0 and 24 Weeks|Sub group population with PBMC FACS data, selected sites only.|||percentage of cells||Standard Deviation|Mean
2587471|NCT02318667|Secondary|Correlation of Serum Soluble ST2 Levels With Histological Activity (Assessed by Geboes Index) at Week 16|ST2, a serum biomarker, was collected at Week 16. Geboes index, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher score indicates more severe disease. Moderate correlation was defined as rs coefficient between -0.5 to -0.3 or 0.3 to 0.5.|Week 16|Analysis population includes all participants who had received study medication and had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity, and had a Week 16 Geboes index score.|||rs coefficient||95% Confidence Interval|Number
2587472|NCT02318667|Secondary|Correlation of Serum Soluble ST2 Levels With Endoscopic Activity (Assessed by Endoscopy Subscore of Mayo Score) at Week 16|ST2, a serum biomarker, was collected at Week 16. Endoscopic Mayo subscore is one of 4 components that comprise the total Mayo Score, a scale for assessing ulcerative colitis (UC) activity. Endoscopic Mayo subscore ranges from 0-3: 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern, mild friability); 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). A higher score indicates more severe disease. Moderate correlation was defined as rs coefficient between -0.5 to -0.3 or 0.3 to 0.5.|Week 16|Analysis population includes all participants who had received study medication and had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity, and had a Week 16 endoscopic Mayo subscore.|||rs coefficient||95% Confidence Interval|Number
2587473|NCT02318667|Secondary|Serum ST2 Level at Week 16|ST2, a serum biomarker, was collected at Week 16. ST2 levels were used to determine whether or not there is a correlation with endoscopic or histologic activity, or a clinical response to treatment in participants with moderate to severe Ulcerative Colitis.|Week 16|Participants with available Week 16 ST2 data.|||ng/mL||Standard Deviation|Mean
2587474|NCT02318667|Primary|Correlation of Serum Soluble ST2 Levels With Histological Activity (Assessed by Geboes Index) at Week 6|ST2, a serum biomarker, was collected at Week 6. Geboes index, is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher score indicates more severe disease. Moderate correlation was defined as rs coefficient between -0.5 to -0.3 or 0.3 to 0.5.|Week 6|Analysis population includes all participants who had received study medication, had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity, and had a Week 6 Geboes index score.|||rs coefficient||95% Confidence Interval|Number
2587475|NCT02318667|Primary|Correlation of Serum Soluble ST2 Levels With Endoscopic Activity of Disease (Assessed by Endoscopy Subscore of Mayo Score) at Week 6|ST2, a serum biomarker, was collected at Week 6. Endoscopic Mayo subscore is one of 4 components that comprise the total Mayo Score, a scale for assessing ulcerative colitis (UC) activity. Endoscopic Mayo subscore ranges from 0-3: 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern, mild friability); 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). A higher score indicates more severe disease. Moderate correlation was defined as a Spearman correlation (rs) coefficient between -0.5 to -0.3 or 0.3 to 0.5.|Week 6|Analysis population includes all participants who had received study medication, had at least one valid post-baseline assessment for the primary endpoint that correlates ST2 with endoscopic activity and/or histological activity, and had a Week 6 endoscopic Mayo subscore.|||Spearman correlation (rs) coefficient||95% Confidence Interval|Number
2587476|NCT02318667|Primary|Serum ST2 Level at Week 6|ST2, a serum biomarker, was collected at Week 6. ST2 levels were used to determine whether or not there is a correlation with endoscopic or histologic activity, or a clinical response to treatment in participants with moderate to severe Ulcerative Colitis.|Week 6|Participants with available Week 6 ST2 data.|||ng/mL||Standard Deviation|Mean
2587477|NCT02318602|Other Pre-specified|Change From Baseline in Frequency of Seizures as a Measure of Seizure Control||through study completion, up to 48 weeks or marketing approval, whichever is earlier|||||||
2587478|NCT02318602|Other Pre-specified|Clinical Global Impression of Improvement (CGI-I)|"The participant's overall clinical condition is compared to the one week period just before the start of medication (the baseline visit). The participant's condition is compared to the patient's condition at admission to the project [prior to starting treatment] on a 7-point scale, where 1=very much improved since the initiation of treatment; and 7=very much worse since the initiation of treatment.~The CGI-I will be completed for all participants, regardless of chronological and developmental age."|through study completion, up to 48 weeks or marketing approval, whichever is earlier|||||||
2587479|NCT02318602|Other Pre-specified|Impact of Pediatric Epilepsy Scale (IPES)|"The IPES assesses the impact on academic achievement, participation in activities, health, relationships with family and with peers and siblings, social activities, self-esteem, and the caregiver's hopes for their child's future. It takes about 3 minutes for the parent to complete. Each of the 11 items is given a severity score of 0 (not at all) to 3 (a lot). The higher the score, the higher is the impact of epilepsy on that item. The highest total score possible is 33 (range 0-33).~The Impact of Pediatric Epilepsy Scale (IPES) is validated for subjects who are 2 to 16 years of age. Due to developmental delay characteristic of the study population, subjects through 18 years of chronological age will complete the IPES. Subjects over 18 years of chronological age will not complete the IPES."|through study completion, up to 48 weeks or marketing approval, whichever is earlier|||||||
2587480|NCT02318602|Other Pre-specified|Clinical Global Impression of Severity (CGI-S)|"The severity of the participant's illness is rated on a seven-point scale, where 1=normal, not at all ill, and 7=among the most extremely ill patients. This rating is based upon observed and reported symptoms, behavior, and function in the past seven days. The score reflects the average severity level across the seven days.~The CGI-S will be completed for all participants, regardless of chronological and developmental age."|through study completion, up to 48 weeks or marketing approval, whichever is earlier|||||||
2601723|NCT02150837|Secondary|Hip Circumference|Hip circumference expressed as an absolute change from baseline.|12 weeks|Not all subjects remaining at 12 weeks had measurement performed.|||Inches||Standard Deviation|Mean
2587481|NCT02318602|Secondary|Number of Participants With a Positive Response on the Columbia-Suicide Severity Rating Scale (C-SSRS)|For subjects 7 years of developmental age or older, the Columbia-Suicide Severity Rating Scale (C-SSRS) will be administered to access suicidality. The appropriate adult version will be used in subjects 12 years of (developmental) age and older. The investigator will determine the participant's developmental age.|Up to Week 50||||Participants|||Count of Participants
2587482|NCT02318602|Secondary|Vineland Adaptive Behavior Scales (VABS)|"The Vineland Adaptive Behavior Scales measures the personal and social skills of individuals from birth through adulthood. Because adaptive behavior refers to an individual's typical performance of the day-to-day activities required for personal and social sufficiency, these scales assess what a person actually does, rather than what he or she is able to do.~The Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) is a measure of adaptive behavior in children, adolescents and adults. It yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains. The 4 domains are Communication, Daily Living Skills, Motor Skills, and Maladaptive Behaviour Index. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. A rise in standard scores from Baseline indicates improvement.~The VABS will be completed for all participants."|Up to Week 48|The Safety Analysis Population (SAF) consisted of all participants in the enrolled population group (ENR) who received at least one dose of the investigational product.|||Score on a scale||Standard Deviation|Mean
2587483|NCT02318602|Primary|Change From Baseline in Trough Plasma Levels of Cannabidiol and Its 7-OH Metabolite||Up to Week 50|Insufficient data was collected to perform study analysis.||||||
2587484|NCT02318602|Primary|Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs||Up to Week 50||||Percentage of participants|||Number
2587485|NCT02318602|Primary|Percentage of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings||Up to Week 48||||Percentage of participants|||Number
2587486|NCT02318602|Primary|Percentage of Participants With Clinically Significant Change From Baseline in Laboratory Values|Laboratory values include chemistry and hematology, and urinary analysis.|Up to Week 50||||Percentage of participants|||Number
2587487|NCT02318602|Primary|Percentage of Participants With Serious Adverse Events|A serious adverse event is any untoward medical occurrence ( whether considered to be related to investigational product or not) that at any dose results in death, is life threatening, requires inpatient hospitalization, results in disability/incapacity, is a congenital abnormality/ birth defect, or medically significant as determined by an investigator.|Up to Week 50||||Percentage of participants|||Number
2587488|NCT02318602|Primary|Percentage of Participants With Adverse Events|An Adverse Event (AE) is any untoward medical occurrence in a subject administered a pharmaceutical product. It does not necessarily have a causal relationship with this treatment.|Up to Week 50||||Percentage of participants|||Number
2587489|NCT02318329|Secondary|Pharmacokinetic (PK) Profile of FPA144: Area Under Serum Concentration-time Curve|"Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2.~• Summary of area under serum concentration-time curve, maximum serum concentration,"|16 weeks on average|All patients in the PK Full Analysis Population who have sufficient PK samples for the calculation of at least one PK parameter on at least one Study Day. Dose normalized PK parameters were reported so that patients at 0.3 mg/kg were excluded from mean value for part 1a because it is in the non-linear dose range.|||ug*day/ml||Standard Deviation|Mean
2587490|NCT02318329|Secondary|Duration of Response Per RECIST 1.1 (Part 2 Only)|Duration of complete or partial response with 95% confidence intervals in gastric cancer population.|16 weeks on average|Gastric cancer patients with various levels of FGFR2b overexpression treated with FPA144 who had an objective response.|||Weeks||95% Confidence Interval|Median
2587491|NCT02318329|Secondary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|16 weeks on average|Patients with various levels of FGFR2b overexpression in tumor samples treated with bemarituzumab who had baseline and post baseline scans performed.|||Participants|||Count of Participants
2587492|NCT02318329|Secondary|Pharmacokinetic (PK) Profile of FPA144: Maximum Serum Concentration|"Sampling following the first dose in Part 1, pre and post-dose at selected cycles, and at the end of treatment for both Part 1 and Part 2.~• Summary of area under serum concentration-time curve, maximum serum concentration,"|16 weeks on average|All patients in the PK Full Analysis Population who have sufficient PK samples for the calculation of at least one PK parameter on at least one Study Day. Dose normalized PK parameters were reported so that patients at 0.3 mg/kg were excluded from mean value for part 1a because it is in the non-linear dose range.|||ug/ml||Standard Deviation|Mean
2587493|NCT02318329|Primary|Number of Participants With AEs and Clinical Laboratory Abnormalities (Parts 1B and 2 Only)|Number of Participants with AEs and clinical laboratory abnormalities (Parts 1B and 2 only)|16 weeks on average|All patients who received FPA144|||Participants|||Count of Participants
2587494|NCT02318329|Primary|Number of Participants With Protocol Specified Dose-limiting Toxicities (Part 1 Only).|Number of participants with grade 3 and grade 4 adverse events (AE) and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs)|4 weeks on average|All patients who received FPA144|||Participants|||Count of Participants
2587508|NCT02317809|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a subject, regardless of causal relationship with the treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include both SAEs and non-serious AEs.|Day 1 post-IMP administration up to follow-up visit (Day 18) for IMP intervention periods|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).|||Subjects|||Number
2587495|NCT02318303|Primary|Change in rTNSS From Baseline to End of Treatment|"Subjects were asked to assess rTNSS (reflective Total Nasal Symptom Score), ie, an evaluation of symptom severity over the past 12 hours prior to the recording of the score. The TNSS was defined as the sum of the subject-reported symptom severity scores for the following four nasal symptoms, recorded by each subject in the diary: rhinorrhea, sneezing, nasal congestion, nasal itching.~The total rTNSS scores for all four symptoms (i.e, the lowest possible score (0) and the highest possible score (12).)~The severity scale for each symptom evaluation was defined as follows:~0 = absent (no sign/symptom evident)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate [i.e., causes interference with activities of daily living and/or sleeping])"|14 days|The full analysis set (FAS) included all randomized subjects who received at least one dose of randomized study medication and had at least one post-baseline primary efficacy assessment. This was the primary analysis set for efficacy analyses.|||units on a scale||Standard Deviation|Mean
2587496|NCT02317809|Secondary|Neutralizing Antibodies (NAbs) Titers for Follicle-stimulating Hormone (FSH)||Day 1 pre-dose, Day 8 post-dose, follow-up visit (Day 49)|Data could not be collected because as per spondor decision, there were no subjects evaluated for NAb due to low titers (noise) for the ADA .||||||
2587497|NCT02317809|Secondary|Anti-Drug Antibodies (ADAs) Titers for Follicle-stimulating Hormone (FSH) at Follow-up Visit||At follow-up visit (Day 49)|"Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). Here, Number of subjects analyzed included those who have positive ADAs values."|||Log Titers|||Number
2587498|NCT02317809|Secondary|Anti-Drug Antibodies (ADAs) Titers for Follicle-stimulating Hormone (FSH)||Day 1 pre-dose and Day 8 post-dose for IMP intervention periods.|"Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). Here, Number of subjects analyzed included those who have positive ADAs values."|||Log Titers|||Number
2587499|NCT02317809|Secondary|Number of Subjects With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Follicle-stimulating Hormone (FSH) at Follow-up Visit||At follow-up visit (Day 49)|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).|||Subjects|||Number
2587500|NCT02317809|Secondary|Number of Subjects With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Follicle-stimulating Hormone (FSH)||Day 1 pre-dose and Day 8 post-dose for IMP intervention periods|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.|||Subjects|||Number
2587501|NCT02317809|Secondary|Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) Titers for Luteinizing Hormone (LH)||Day 1 pre-dose up to follow-up visit (Day 18) for IMP intervention periods|Data could not be collected as there were no subjects with positive results for ADAs and NAbs.||||||
2587502|NCT02317809|Secondary|Number of Subjects With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Luteinizing Hormone (LH)||Day 1 pre-dose up to follow-up visit (Day 18) for IMP intervention periods|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).|||Subjects|||Number
2587503|NCT02317809|Secondary|Pain Visual Analogue Scale (VAS) Score|The severity of pain was evaluated by the subject and recorded using a 100 millimeter (mm) visual analogue scale (VAS) ranging from 0 to 100, where 0 mm = no pain and 100 mm = worst possible pain.|5 minutes, 1, 2, 4, 6, 12, and 24 hours post-dose in each period|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). Here “n” signifies those subjects who were evaluable for the specified time point in each arm, respectively.|||mm||Standard Deviation|Mean
2587504|NCT02317809|Secondary|Number of Subjects With Local Tolerability/Injection Site Reactions (ISRs)|Injection site was assessed by the study site staff for any local reaction (redness, swelling, bruising, and itching). Redness and bruising were scaled as None (no visible redness or bruising); Mild (less than or equal to [<=] 2.0 centimeters [cm] redness or bruising); Moderate (greater than [>] 2 to <=5.0 cm redness or bruising); Severe (>5.0 cm redness or bruising). Swelling was scaled as None (no swelling detected); Mild (palpable 'firmness' only); Moderate (<= 4 cm swelling); Severe (>4 cm swelling). Itching was scaled as None (no itching); Mild itching; Moderate itching and Severe itching. Only those scale categories which report at least 1 subject were presented.|5 minutes, 1, 2, 4, 6, 12, and 24 hours post-dose in each period|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation). Here “n” signifies those subjects who were evaluable for the specified injection site reaction at the specified time point for each arm, respectively.|||Subjects|||Number
2587505|NCT02317809|Secondary|Serum Estradiol Levels|Data was planned to be presented as per the sequence of treatment received.|Screening (up to 28 days), Day 1 (pre-dose) and Day 8 in Period 1, Day 1 (pre-dose), Day 8 and follow-up (Day 18) in Period 2|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).|||nanogram per liter (ng/L)||Standard Deviation|Mean
2587506|NCT02317809|Secondary|Number of Subjects With Follicle Size Greater Than (>)13 Millimeter|Transvaginal ultrasound (TVUS) was performed to determine the follicle size and number.|Day 1 (pre-dose) up to follow-up visit (Day 18) for IMP intervention periods|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).|||Subjects|||Number
2587507|NCT02317809|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs) Related to Laboratory Assessments, Vital Signs or Electrocardiogram Findings||Day 1 post-IMP administration up to follow-up visit (Day 18) for IMP intervention periods|Safety analysis set included all subjects who received at least 1 dose of the investigational medicinal product (IMP) (that is, either liquid formulation or freeze-dried formulation).|||Subjects|||Number
2587509|NCT02317809|Secondary|Apparent Volume of Distribution During Terminal Phase (Vz/F) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired concentration. Apparent volume of distribution (Vz/F) is influenced by the fraction absorbed.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.|||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
2587510|NCT02317809|Secondary|Apparent Serum Clearance (CL/F) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|Clearance is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained is influenced by the fraction of the dose absorbed and was expressed as volume (Liter) per unit of time (hour).|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.|||Liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2587511|NCT02317809|Secondary|Apparent Terminal Half-life (t1/2) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|Terminal half-life is the time measured for the concentration to decrease by one half.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.|||Hour (h)||Geometric Coefficient of Variation|Geometric Mean
2587512|NCT02317809|Secondary|Time to Reach the Maximum Serum Concentration (Tmax) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)||Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.|||Hour (h)||Full Range|Median
2587513|NCT02317809|Secondary|Apparent Terminal Elimination Rate Constant (Lambda[z]) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|The elimination rate constant was obtained from linear regression of the terminal phase of the log transformed concentration-time data.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.|||Per Hour (1/hour)||Geometric Coefficient of Variation|Geometric Mean
2587514|NCT02317809|Secondary|Baseline Corrected Area Under the Serum Concentration-time Curve From Time Tlast Extrapolated to Infinity (%AUCextra,Adj) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)|Area under the serum concentration-time curve from Tlast extrapolated to infinity given as a percentage of AUC0-inf. Data was not planned to be summarized if AUCextra,adj was less than 20%.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|As per statistical analysis plan, data was not planned to be summarized because AUCextra,adj was below 20% for all the participants.||||||
2587515|NCT02317809|Secondary|Baseline Corrected Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUC0-inf, Adj) for Follicle-stimulating Hormone (FSH) and Luteinizing Hormone (LH)||Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120, 168 hours post-dose in each period for FSH; Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 hours post-dose in each period for LH|PK analysis set. Here “n” signifies those subjects who were evaluable for the specified hormone level in each arm, respectively.|||International units*hour/liter (IU*h/L)||Geometric Coefficient of Variation|Geometric Mean
2587516|NCT02317809|Primary|Baseline Corrected Maximum Serum Concentration (Cmax,Adj) for Luteinizing Hormone (LH)|Baseline-corrected Cmax (Cmax,adj) = Cmax - baseline concentration.|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96 and 120 hours post-dose in each period|Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.|||International units per liter (IU/L)||Geometric Coefficient of Variation|Geometric Mean
2587517|NCT02317809|Primary|Baseline Corrected Maximum Serum Concentration (Cmax,Adj) for Follicle-Stimulating Hormone (FSH)|Baseline-corrected Cmax (Cmax,adj) = Cmax - baseline concentration|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 and 168 hours post-dose in each period|Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.|||International units per liter (IU/L)||Geometric Coefficient of Variation|Geometric Mean
2587518|NCT02317809|Primary|Baseline Corrected Area Under the Concentration-Time Curve From Zero to Last Quantifiable Concentration (AUC0-t,Adj) for Luteinizing Hormone (LH)|The AUC (0-t) was defined as the area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration. Baseline-corrected AUC0-t (AUC0-t,adj) = AUC0-t - (baseline concentration * t).|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96 and 120 hours post-dose in each period|Pharmacokinetic (PK) analysis set: all randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully downregulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.|||International units*hour/liter (IU*h/L)||Geometric Coefficient of Variation|Geometric Mean
2587519|NCT02317809|Primary|Baseline Corrected Area Under the Concentration-Time Curve From Zero to Last Quantifiable Concentration (AUC 0-t,Adj) for Follicle-Stimulating Hormone (FSH)|The AUC (0-t) was defined as the area under the serum concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration. Baseline-corrected AUC0-t (AUC0-t,adj) = AUC0-t - (baseline concentration * t).|Pre-dose, 2, 4, 6, 7, 8, 9, 10, 12, 15, 18, 24, 36, 48, 60, 72, 96, 120 and 168 hours post-dose in each period|Pharmacokinetic (PK) analysis set: All randomized subjects who were treated with both liquid and freeze-dried formulations and had absence of relevant protocol violations, had availability of the primary target variables and successfully down regulated baseline levels of FSH and LH below 1.0 IU/L in both the screening and dedicated PK assays.|||International units*hour/liter (IU*h/L)||Geometric Coefficient of Variation|Geometric Mean
2587520|NCT02317744|Secondary|Body Mass Index (BMI)|BMI is calculated using measured height and weight.|6 month follow-up (an average of 6 months following treatment)||||kg/m^2||Full Range|Mean
2587521|NCT02317744|Secondary|Body Mass Index (BMI)|BMI is calculated using measured height and weight.|Post-treatment (at 3 months)||||kg/m^2||Full Range|Mean
2587522|NCT02317744|Primary|Binge Eating Frequency (Continuous)|Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).|6 month follow-up (an average of 6 months following treatment)||||binge eating days (out of 28)||Full Range|Mean
2587523|NCT02317744|Primary|Binge Eating Frequency (Continuous)|Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).|Post-treatment (at 3 months)||||binge eating days (out of 28)||Full Range|Mean
2587524|NCT02317692|Secondary|Effects of Socioeconomic Status and Parental Acculturation on Treatment Outcomes (Parental Report)|Socioeconomic status computed based on parental report of education and occupation (assessed on demographic form). Acculturation based on parental report on the Acculturation Rating Scale for Mexican Americans-II and the Mexican American Cultural Values for Adolescents and Adults.|8 weeks|We did not examine this outcome measure due to a lack of variability on the SES and acculturation measure.||||||
2587525|NCT02317692|Secondary|Change in Parental Functioning (Maternal Parenting Stress)|Pre-treatment to post-treatment change on summary score of Parenting Stress Index-Short Form (completed by mothers) Range=0-144; the larger the number, the greater stress Difference in mean pre and post scores for each group, so SD was not calculated.|8 weeks|Only mothers completed.|||units on a scale|Families||Number
2587526|NCT02317692|Secondary|Change in ADHD Symptoms (Inattention Subscale of Disruptive Behavior Disorders Rating Scale)|Pre-treatment to post-treatment change on inattention subscale of Disruptive Behavior Disorders Rating Scale (completed by parent) Range=0-3; the larger the number, the greater the symptoms Difference in mean pre and post scores for each group, so SD was not calculated.|Baseline to 8 weeks||||units on a scale|Families||Number
2587527|NCT02317692|Primary|Acceptability of Treatment (Summary Score of Therapy Attitude Inventory)|Parental report of satisfaction with treatment (summary score of Therapy Attitude Inventory) Range=10-50; higher scores represent greater satisfaction (a better outcome)|8 weeks||||units on a scale|Families|Standard Deviation|Mean
2587528|NCT02317692|Primary|Engagement in Treatment - Homework Completion (% of Completed Homework)|(recorded by clinician - homework was assigned every week and was expected to be returned at the next week's session)|8 weeks||||percentage of completed homework|Families|Standard Deviation|Mean
2587529|NCT02317692|Primary|Engagement in Treatment - Sessions Attended|Number of sessions attended by each family (recorded by clinician)|8 weeks||||sessions|Families|Standard Deviation|Mean
2587530|NCT02317692|Primary|Engagement in Treatment - Treatment Completion (Number of Families Who Completed Treatment)|Number of families who completed treatment (recorded by clinician)|8 weeks||||Families|Families||Count of Units
2587531|NCT02317614|Other Pre-specified|Opiate and Cocaine Use|Measured using monthly self-report. Response will be binary (Yes/No). The percentage of the participants that reported yes will be recorded for each month and then an average for the 6 month period calculated.|Six months|Includes data from six months (repeated measures), with missing data treated as missing. Percent of participants reporting use of either cocaine, opiates, or both is the reported value.|||percentage of participants||Standard Deviation|Mean
2587532|NCT02317614|Other Pre-specified|Mental and Physicial Health as Assessed by the Medical Outcomes Study HIV Health Survey (MOS-HIV)|The 35-item questionnaire includes ten dimensions (health perceptions, pain, physical, role, social and cognitive functioning, mental health, energy, health distress and quality of life (QoL). Subscales are scored on a 0-100 scale (a higher score indicates better health) and separate physical and mental health summary scores are calculated. Summary scores for these items are transforms with a mean of 50 and a standard deviation of 10. Thus, for both scores, being of average (physical or mental) health leads to a score of 50, with a range of 20 to 80.|Six months||||score on a scale||Standard Deviation|Mean
2587533|NCT02317614|Secondary|Viral Load|Actual HIV-RNA levels, measured at the same time as the undetectable viral load outcome measure|Six months||||copies/mL blood||Standard Error|Mean
2587534|NCT02317614|Secondary|Monthly Percent Adherence to Antiretroviral Medications.|"This measure is calculated for each participant in each study month. The number of days in the month in which the participant correctly consumed their antiretroviral medication is divided by the number of days in the month. The measure is collected by an electronic pill bottle cap (a.k.a. MEMS cap)."|Six months||||percentage of adherence to ART||Standard Error|Mean
2587535|NCT02317614|Primary|Percentage of Participants Achieving an Undetectable Viral Load in Six Months|Measured twice in six months to assess the percentage of participants to achieve a viral load <400 HIV-RNA/mL (Y/N)|Six months||||percentage of participants|||Number
2587536|NCT02317614|Primary|Medication Adherence as Assessed by the Medication Event Monitoring System (MEMS) Cap|The MEMS cap is a device that records the date and time whenever a patient opens a vial to monitor medication adherence. Percentage of participant to achieve 95% adherence will then be recorded.|Six months|Participants' monthly data over six months were included. Missing data were treated as missing.|||percentage of participants|||Number
2587578|NCT02316717|Other Pre-specified|Serum Concentrations of C-Reactive Protein (CRP)|Mean Serum Concentrations of C-Reactive Protein (CRP) at week 24|baseline to 24 Weeks|assessed at 0, 4, 12 and 24 Weeks, change from baseline to week 24 reported|||mg/L||Standard Deviation|Mean
2587537|NCT02317549|Primary|Number of Days Alive Without Cardiovascular, Renal or Pulmonary Organ Support|"The patient will be classified as having organ support if organ support is required through the use of:~Mechanical ventilation;~Vasopressors to maintain adequate blood pressure (BP), or~Renal replacement therapy."|Through day 28.|5 subjects were treated with LB1148, and 3 subjects were treated with placebo. Upon review of patient charts after the study was terminated, 1 patient on placebo was enrolled on the basis of a Glasgow Coma Score calculated while under sedation, which allowed SOFA score to meet study criteria and the patient to be inappropriately enrolled.|||days||Full Range|Mean
2587538|NCT02317510|Secondary|Headache|Group 1 and Group 2 Headache|from end of the operation to postoperative 3 days|All patients have gall bladder disease who are between 18-90 years old.|||participants|||Number
2587539|NCT02317510|Secondary|Nausea/Vomiting|Group 1 and group 2 nausea/vomiting|from end of the operation to postoperative 1 day|All patients have gall bladder disease who are between 18-90 years old.|||participants|||Number
2587540|NCT02317510|Secondary|Urinary Retention|Group 1 and Group 2 Urinary retention|from end of the operation to postoperative 1 day|All patients have gall bladder disease who are between 18-90 years old|||participants|||Number
2587541|NCT02317510|Secondary|Intra-operative Shoulder Pain|Group 1 and Group 2 Intra-operative shoulder pain|during operation time, up to 2 hours|All patients have gall bladder disease who are between 18-90 years old.|||participants|||Number
2587542|NCT02317510|Primary|Post-operative Shoulder Pain|Group 1 and Group 2 Post-operative shoulder pain|from end of the operation to postoperative 3 days|All patients have gall bladder disease who are between 18-90 years old|||participants|||Number
2587543|NCT02317510|Secondary|Post-operative Abdominal Pain 24th Hour|VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 24th hour|All patients have gall bladder disease who are between 18-90 years old.|||units on a scale||Standard Deviation|Least Squares Mean
2587544|NCT02317510|Secondary|Post-operative Abdominal Pain 12th Hour|VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 12th hour|All patients have gall bladder disease who are between 18-90 years old.|||units on a scale||Standard Deviation|Least Squares Mean
2587545|NCT02317510|Secondary|Post-operative Abdominal Pain 6th Hour|VAS score;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 6th hour|All patients have gall bladder disease who are between 18-90 years old.|||units on a scale||Standard Deviation|Least Squares Mean
2587546|NCT02317510|Secondary|Post-operative Abdominal Pain 4th Hour|VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 4th hour|All patients have gall bladder disease who are between 18-90 years old.|||units on a scale||Standard Deviation|Least Squares Mean
2587547|NCT02317510|Secondary|Post-operative Abdominal Pain 2nd Hour|VAS score ;Explain to the person that each number describe the intensity of his pain. Number 0 describe very happy and no pain and no hurt at all. Number 1 hurts just a little bit. And as te numbers gradually increase pain will increase. Number 10 describes the worst pain in his life. Ask the patient to choose the number that best describes how he is feeling and his pain.|pain at postoperative 2nd hour|All patients have gall bladder disease who are between 18-90 years old.|||units on a scale||Standard Deviation|Least Squares Mean
2587548|NCT02317510|Secondary|Duration of Anaesthesia|Group 1 minimum 42 minutes and maximum 83 minutes.mean duration of anaesthesia 60.17 and Group 2 minimum 45 minutes and maximum 82 minutes mean duration of anaesthesia 60.23|up to 2 hours|All patients have gall bladder disease who are between 18-90 years old.|||minutes||Standard Deviation|Mean
2587549|NCT02317510|Primary|Duration of Operation|group 1:surgical operation time is 20 minutes minimum and maximum 55 minutes. Mean operation time 36.56 minutes group 2:surgical operation time is 24 minutes minimum and maximum 53 minutes. Mean operation time 30.75 minutes|up to 2 hours|All patients have gall bladder disease who are between 18-90 years old.|||minutes||Standard Deviation|Mean
2587550|NCT02317276|Primary|Change in Blood and Tissue Levels of Biomarkers Following Treatment of Atopic Dermatitis With Topical Corticosteroids.|The blood and skin biomarkers to be evaluated include but are not limited to eosinophils, Immunoglobulin E (IgE), Interleukin 13 (IL-13), Chemokine ligand 13 (CCL-13), and Chemokine ligand 17 (CCL-17). These biomarkers will be evaluated for differential gene expression and protein levels in samples obtained from atopic dermatitis patients on and off topical corticosteroid treatment.|Baseline to Week 8|No samples were analyzed for the primary outcome measure of change in blood and tissue levels. Since the study was terminated, the blood and tissue samples were not analyzed as planned.||||||
2587551|NCT02317016|Secondary|Assessment of the Metabolite to Parent Ratios of AUCtau (MRAUCtau) for AZ5104 and AZ7550 Following Administration of AZD9291 and Rosuvastatin Together|Assessment of MRAUCtau for AZ5104 and AZ7550 (calculated as AZ5104 to AZD9291 and AZ7550 to AZD9291) after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2587579|NCT02316717|Other Pre-specified|Serum Concentrations of LPS|Serum Concentrations of Lipopolysaccharide (LPS) (ng/mL) levels and change from Baseline|baseline to 24 Weeks|assessed at 0, 4, 12 and 24 Weeks, change from baseline to week 24 reported|||ng/mL||Standard Deviation|Mean
2587552|NCT02317016|Secondary|Assessment of the Metabolite to Parent Ratios of Css,Max (MRCss,Max) for AZ5104 and AZ7550 Following Administration of AZD9291 and Rosuvastatin Together|Assessment of MRCss,max for AZ5104 and AZ7550 (calculated as AZ5104 to AZD9291 and AZ7550 to AZD9291) after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2587553|NCT02317016|Secondary|Assessment of Apparent Plasma Clearance at Steady State (CLss/F) for AZD9291 Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291 by assessment of CLss/F after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2587554|NCT02317016|Secondary|Assessment of Minimum Plasma Concentration at Steady State (Css,Min) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of Css,min over the dosing interval. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM||Geometric Coefficient of Variation|Geometric Mean
2587555|NCT02317016|Secondary|Assessment of Time to Reach Maximum Plasma Concentration at Steady State (Tss,Max) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of tss,max after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||h||Full Range|Median
2587556|NCT02317016|Secondary|Assessment of Maximum Plasma Concentration at Steady State (Css,Max) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of Css,max after multiple dosing. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM||Geometric Coefficient of Variation|Geometric Mean
2587557|NCT02317016|Secondary|Assessment of Area Under the Plasma Concentration-time Curve During the Dosing Interval (AUCtau) for AZD9291, and AZ5104 and AZ7550 (Metabolites) Following Administration of AZD9291 and Rosuvastatin Together|Rate and extent of absorption for AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of AUCtau. AZD9291 doses were first without, then with rosuvastatin (Days 4 to 31; Period 2 and Day 32; Period 3, respectively).|Blood samples collected pre-dose on Days 11, 18, and 25 and on Day 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, and 24 hours post AZD9291 dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nanomolar * h (nM*h)||Geometric Coefficient of Variation|Geometric Mean
2587558|NCT02317016|Secondary|Assessment of Terminal Elimination Half-life (t1/2[lambda_z]) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of t1/2(lambda_z). Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||h||Geometric Coefficient of Variation|Geometric Mean
2587559|NCT02317016|Secondary|Assessment of Apparent Volume of Distribution (Vz/F) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of Vz/F. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||L||Geometric Coefficient of Variation|Geometric Mean
2587560|NCT02317016|Secondary|Assessment of Apparent Plasma Clearance (CL/F) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of CL/F. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||Litre / h (L/h)||Geometric Coefficient of Variation|Geometric Mean
2587580|NCT02316717|Other Pre-specified|Gut Microbiome From Fecal Samples|Number of participants with measurable differences in gut microbiome constituents post-treatment|0, 4, 12 and 24 Weeks||||Participants|||Count of Participants
2587561|NCT02317016|Secondary|"Assessment of Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration at Time t (AUC0-t) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291"|Rate and extent of absorption of rosuvastatin by assessment of AUC0-t. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2587562|NCT02317016|Secondary|Assessment of Time to Maximum Plasma Concentration (Tmax) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of tmax. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||h||Full Range|Median
2587563|NCT02317016|Primary|Assessment of AUC From Time Zero Extrapolated to Infinity for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of AUC from time zero extrapolated to infinity. Single rosuvastatin doses were first without, then with AZD9291 (Day 1; Period 1 and Day 32; Period 3, respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||ng * h o u r per mL (ng*h/mL )||Geometric Coefficient of Variation|Geometric Mean
2587564|NCT02317016|Primary|Assessment of Maximum Plasma Concentration (Cmax) for Rosuvastatin After a Single Dose Alone and in Combination With AZD9291|Rate and extent of absorption of rosuvastatin by assessment of Cmax. Single rosuvastatin doses were first without, then with AZD9291 (Day 1 [Period 1] and Day 32 [Period 3], respectively).|Blood samples collected on Days 1 and 32 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 60, and 72 hours post rosuvastatin dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nanogram per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2587565|NCT02316847|Primary|Change in Taste as Measured by a Taste Change Questionnaire|Change in taste questionnaire was administered to subjects at every study visit only if the subject complained of a change in taste or as needed to report a related AE. The taste change profile included sweet, salty, sour, bitter, oily, sharp, chalky, metallic. The subject rated the change on a 10-point scale ranging from a weak change (1) to very strong (10).|Weeks 12, 24|Safety Population - Number of subjects with at least one change in taste after dose administration. 6 Adults at 12 Weeks and 4 Adults at 24 weeks. No Adolescents participated.|||units on a scale||Standard Deviation|Mean
2587566|NCT02316847|Primary|Change From Baseline (Screening) in Nasal Mucosa.|"Change from baseline treatment visits using a focused nasal exam was based on a scale of nasal irritation none to Grade 4 septal perforation."|Screening, Weeks 12, 24, 36, 48 and 51|Safety Population|||Participants|||Count of Participants
2587567|NCT02316847|Primary|Olfactory Changes as Measured by the Smell Identification Test (SIT)|The SIT is a 50-item multiple-choice standardized test of olfactory function. Scoring of the test in the ability to smell ranges from normal (Normosmia: score 35 - 40 Women; 34 - 40 Men); to inability to smell (Anosmia score 6 - 18); or Malingering (not engaged in the test) ranges 0 - 5.|Screening, weeks 12, 24, 36, 48 and 51|Of 91 subjects in the Safety Population, data was available for 62 subjects at screening.|||Participants|||Count of Participants
2587568|NCT02316769|Secondary|Time to Intubation|Number of patients intubated in less than 90 seconds|Intubation time was initiated at the time of entry of the study device beyond the teeth/gum line and the intubation time was stopped when the study device was removed beyond the same point.||||participants|||Number
2587569|NCT02316769|Primary|Intubation Success on First Attempt as Measured by End Tidal Carbon Dioxide||participants were followed up to the point the video device is removed from the airway, classified as under 90 seconds.||||participants|||Number
2587570|NCT02316717|Other Pre-specified|Regulatory T Cells (FoxP3+CD25-CD8+) in Peripheral Blood Mononuclear Cells|Change in percent of FoxP3+CD25-CD8+ cells in Peripheral Blood Mononuclear Cells|0 and 24 Weeks|Sub group population with PBMC FACS data, selected sites only.|||percentage of cells||Standard Deviation|Mean
2587571|NCT02316717|Other Pre-specified|Serum Concentration of Glucagon-like Peptide-1 (GLP-1)|Mean Change from baseline to week 24 of serum concentration of GLP-1|24 weeks|ITT population|||pM||Standard Deviation|Mean
2587572|NCT02316717|Other Pre-specified|Serum Concentration of Tumor Necrosis Factor Alpha (TNF-α)|Mean Change from baseline to week 24 of serum concentration of TNF-α|24 weeks|ITT population|||pg/mL||Standard Deviation|Mean
2587573|NCT02316717|Other Pre-specified|Serum Concentration of Interferon Gamma (IFN-γ)|Mean Change from baseline to week 24 of serum concentration of IFN-gamma|24 weeks|ITT population|||pg/mL||Standard Deviation|Mean
2587574|NCT02316717|Other Pre-specified|Serum Concentration of Cytokine IL-12p70|Mean change from baseline to week 24 of Serum concentration of Cytokine IL-12p70|24 weeks|ITT population|||pg/mL||Standard Deviation|Mean
2587575|NCT02316717|Other Pre-specified|Serum Concentrations of Cytokine IL-6|Mean Change from baseline to week 24 of serum concentration of cytokine IL-6|24 weeks|ITT population|||pg/mL||Standard Deviation|Mean
2587576|NCT02316717|Other Pre-specified|Serum Concentrations of Human Adiponectin|Change from Run-in to Post-treatment in serum concentration of human Adiponectin.|0 to 24 Weeks|ITT population. Run-in = mean of screening and baseline values. assessed at 0, 4, 12 and 24 Weeks, change from baseline to week 24 reported|||pg/mL||Standard Deviation|Mean
2587577|NCT02316717|Other Pre-specified|Serum Concentrations of CK-18 Fragments|The proportion of subjects with significant reduction of CK-18 (≥ 15%) between IMP 1200mg group to placebo.|baseline to 24 weeks|FAS population, excluding outlier sites. this Outcome Measure was pre-specified to be assessed in the 1200mg and Placebo Arms/Groups *only*|||Participants|||Count of Participants
2587582|NCT02316717|Other Pre-specified|Serum Concentrations of Lipopolysaccharide (LPS)|The percentage of subjects reporting at least 15% reduction in LPS, from baseline to Week 24|0, 4, 12 and 24 Weeks|excluding subjects with < 250 LPS at baseline (comparing 1200mg IMP group to Placebo group). PP population, excluding outliers sites. this Outcome Measure was pre-specified to be assessed in the 1200mg and Placebo Arms/Groups *only*|||Participants|||Count of Participants
2587583|NCT02316717|Secondary|Serum Alanine Aminotransaminase (ALT)|Number of patients with ALT within the normal reference range at Week 24 (defined a <19 IU/L for women and <30 IU/L for men)|24 Weeks||||Participants|||Count of Participants
2587584|NCT02316717|Secondary|Gamma Glutamyl Transpeptidase (GGT)|Mean change from Baseline of Gamma Glutamyl Transpeptidase (GGT)|baseline to 24 Weeks|assessed at 0, 4, 8, 12, 16, 20 and 24 Weeks, change from baseline to week 24 reported|||U/L||Standard Deviation|Mean
2587585|NCT02316717|Secondary|Albumin|Mean change from Baseline of Albumin|baseline to 24 Weeks|assessed at 0, 4, 8, 12, 16, 20 and 24 Weeks, change from baseline to week 24 reported|||g/dL||Standard Deviation|Mean
2587586|NCT02316717|Secondary|Bilirubin|Mean change from Baseline of Bilirubin|baseline to 24 Weeks|assessed at 0, 4, 8, 12, 16, 20 and 24 Weeks, change from baseline to week 24 reported|||umol/l||Standard Deviation|Mean
2587587|NCT02316717|Secondary|Serum Aspartate Aminotransaminase (AST)|Mean change from Baseline of Serum AST|baseline to 24 Weeks|assessed at 0, 4, 8, 12, 16, 20 and 24 Weeks, change from baseline to week 24 reported|||IU/L||Standard Deviation|Mean
2587588|NCT02316717|Secondary|Serum Alanine Aminotransaminase (ALT)|Mean change from Baseline of serum ALT|baseline to 24 weeks|assessed at 0, 4, 8, 12, 16, 20 and 24 Weeks, change from baseline to week 24 reported|||IU/L||Standard Deviation|Mean
2587589|NCT02316717|Secondary|High Density Lipoprotein (HDL)|Change from Baseline of High Density Lipoprotein (HDL) at 24 weeks|24 Weeks||||mmol/l||Standard Deviation|Mean
2587590|NCT02316717|Secondary|Low Density Lipoprotein (LDL)|Change from Baseline of Low Density Lipoprotein (LDL) at 24 weeks|24 Weeks||||mmol/l||Standard Deviation|Mean
2587591|NCT02316717|Secondary|Triglycerides|Change from Baseline of Triglycerides at 24 weeks|24 Weeks||||mmol/l||Standard Deviation|Mean
2587592|NCT02316717|Secondary|Total Cholesterol|Change from Baseline of Total Cholesterol at 24 weeks|24 Weeks||||mmol/l||Standard Deviation|Mean
2587593|NCT02316717|Secondary|Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)|Change from Baseline of Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 24 weeks|baseline and 24 Weeks|HOMA-IR is calculated according to the formula: fasting insulin (mU/mL) x fasting glucose (mmol/L)/22.5|||no unit||Standard Deviation|Mean
2587594|NCT02316717|Secondary|Hemoglobin (HB)A1C|Change from Baseline of Hemoglobin(HB)A1C at 24 weeks|24 Weeks||||percentage||Standard Deviation|Mean
2587595|NCT02316717|Secondary|Waist:Hip Ratio|Change from Baseline of Waist:Hip Ratio at 24 weeks|24 Weeks||||ratio||Standard Deviation|Mean
2587596|NCT02316717|Secondary|Waist Circumference|Change from Baseline of Waist Circumference at 24 weeks|24 Weeks||||cm||Standard Deviation|Mean
2587597|NCT02316717|Secondary|Body Mass Index (BMI)|Change from Baseline of Body Mass Index (BMI) at 24 weeks|24 Weeks||||kg/m^2||Standard Deviation|Mean
2587598|NCT02316717|Secondary|Elimination Half Life (T1/2)|Elimination Half Life (T1/2) of IMM-124E|0, 4, 12 and 24 Weeks|The investigational product is orally active and not systemically absorbed into the blood stream. This analysis purpose was to confirm this claim and show there is no absorption to blood stream.|||seconds||Standard Deviation|Mean
2587599|NCT02316717|Secondary|Area Under the Concentration Time Curve (AUC)|Area Under the Concentration Time Curve (AUC) of IMM-124E. Time points at which data were collected: baseline pre-dose, week 4, week 12 and week 24.|0, 4, 12 and 24 Weeks|The investigational product is orally active and not systemically absorbed into the blood stream. This analysis purpose was to confirm this claim and show there is no absorption to blood stream.|||ng/mL||Standard Deviation|Mean
2587600|NCT02316717|Secondary|Minimum Serum Concentration (Cmin)|Minimum serum concentration (Cmin) of IMM-124E|0, 4, 12 and 24 Weeks|The investigational product is orally active and not systemically absorbed into the blood stream. This analysis purpose was to confirm this claim and show there is no absorption to blood stream.|||ng/mL||Standard Deviation|Mean
2587601|NCT02316717|Secondary|Peak Serum Concentration (Cmax)|Peak serum concentration (Cmax) of IMM-124E|0, 4, 12 and 24 Weeks|The investigational product is orally active and not systemically absorbed into the blood stream. This analysis purpose was to confirm this claim and show there is no absorption to blood stream.|||ng/mL||Standard Deviation|Mean
2587602|NCT02316717|Secondary|Serum Alanine Aminotransaminase (ALT)|Mean change from Baseline in Serum Alanine Aminotransaminase (ALT) at Week 24|baseline and 24 weeks||||IU/L||Standard Deviation|Mean
2587603|NCT02316717|Secondary|Respiratory Rate|Mean change in Respiratory Rate from baseline to week 24|baseline and 24 weeks|The analysis population includes subjects with both respiratory rate data at baseline and week 24|||breaths/minute||Standard Deviation|Mean
2587604|NCT02316717|Secondary|Diastolic Blood Pressure|Change in Diastolic Blood Pressure|baseline and 24 weeks|The analysis population include subjects with data of both baseline and week 24|||mmHg||Standard Deviation|Mean
2587605|NCT02316717|Secondary|Pulse Rate|Mean change in Pulse Rate from baseline to week 24|baseline and 24 weeks|The analysis population include subjects with Pulse Rate data of both baseline and week 24|||beats/minute||Standard Deviation|Mean
2587606|NCT02316717|Secondary|Systolic Blood Pressure|Mean change in Systolic Blood Pressure|baseline and 24 weeks|The analysis population include subjects with data of both baseline and week 24|||mmHg||Standard Deviation|Mean
2587607|NCT02316717|Primary|Severity of Adverse Events|Number of grade 3-5 adverse events|24 weeks|Number of grade 3-5 AEs|||events|||Number
2587608|NCT02316717|Primary|Adverse Events|Number of patients with treatment-related adverse events|24 weeks|Number of patients with any treatment-related AE|||Participants|||Count of Participants
2587609|NCT02316717|Primary|Percentage Fat Content of the Liver|Mean change from Baseline in Percentage Fat Content of the Liver measured by Magnetic Resonance Imaging (MRI) at Week 24|baseline and 24 weeks|The analysis population includes subjects with both baseline MRI and week 24 MRI.|||percentage of hepatic fat fraction||Standard Deviation|Mean
2587610|NCT02316717|Primary|Safety Outcome Measure|Incidence of adverse events per arm/group|24 Weeks|Number of treatment emerged AEs per arm/group|||AEs|||Number
2587611|NCT02316678|Primary|Mortality Rate|"Incidence of death per 1000 person-years~Outcome Measure Time Frame:Follow-up was from the date that the participant first met the criteria for either prolonged corticosteroid use or new anti-TNF use until either the patient died, discontinued enrollment in Medicaid or Medicare Part A, B, or D, reached age 90, was newly diagnosed with other immune-mediated diseases or AIDS, or reached the end of the available data, whichever came first, assessed up to 13 years. Follow-up of patients with UC also ended if they were diagnosed with a fistula, as this would usually change the diagnosis to CD."|See Outcome Measure Description above|Patients treated with corticosteroids (CS) within the prior year and subsequently received either additional CS therapy meeting the definition of prolonged CS use or newly initiated anti-TNF therapy were included in the study.|||events per 1000 person-years|||Number
2587612|NCT02316613|Secondary|Number and Type of Hospitalization Associated With MabThera Perfusion|Number and type of hospitalization (a day hospitalization, short-lasting hospitalization, and short-stay hospitalization) was reported.|Up to 6 years|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.|||hospitalizations|Participants||Number
2587613|NCT02316613|Secondary|Function Assessment of Chronic Illness Therapy-General (FACT-G) With Lymphoma-Specific Additional Concerns Subscale (Lym) Total Score|"The FACT-G with Lymphoma-Specific Additional Concerns Subscale (Lym) total score was calculated by adding the score obtained on the FACT-G (physical well-being, scored 0-28; social well-being, scored 0-28; functional well-being, scored 0-28; emotional well-being, scored 0-24), to the score obtained on the LYM subscale (15 items; responses to each item range from 0, Not at all to 4, Very much). Total score ranges from 0 to 168. Higher scores indicated a better participant-reported outcome/quality of life over the past week when responding to the items."|Up to 6 years (assessed at start, mid and end of induction [induction: 18.7 months], at each infusion during maintenance [maintenance phase: 67.8 months], and at disease progression [maximum up to 6 years])|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. n=number of evaluable questionnaires for each category.|||score on scale|Participants|Standard Deviation|Mean
2587614|NCT02316613|Secondary|Percentage of Participants With Discontinuations and Modifications of MabThera During Maintenance Phase||Maintenance phase : 67.8 months|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one MabThera infusion over the maintenance therapy period. n=number of evaluable participants for each category.|||percentage of participants|||Number
2587615|NCT02316613|Secondary|MabThera Regimen: Time Between Cycles||Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data.|||days||Standard Deviation|Mean
2587616|NCT02316613|Secondary|MabThera Regimen: Number of Cycles of MabThera||Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data for this outcome.|||number of cycles||Standard Deviation|Mean
2587617|NCT02316613|Secondary|MabThera Regimen: Infusion Duration||Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data.|||minutes (mn)||Standard Deviation|Mean
2587618|NCT02316613|Secondary|MabThera Regimen: Dose of MabThera|All participants who received MabThera treatment before the first disease progression were reported.|Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants who received at least one cycle of MabThera and available with valid data for this outcome.|||milligram (mg)||Standard Deviation|Mean
2587619|NCT02316613|Primary|Number of Participants With Therapeutic Management After the First Study Disease Progression|After the first disease progression the participants received chemotherapy, immunotherapy, radio immunotherapy, stem cell transplantation, or radiation therapy for therapeutic management of the refractory/relapsed follicular non-Hodgkin's lymphoma. One participant could receive more than one type of treatment after the first study disease progression.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period.|||participants|||Number
2587620|NCT02316613|Primary|Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression|"The therapeutic management of participants was decided by either pluri-disciplinary consultation meeting, Only the physician in charge of the participant, Discussion between physicians, or Punctual consultation of an external physician. Percentage of participants with each of these modalities of therapeutic decision was reported."|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period.|||percentage of participants|||Number
2587621|NCT02316613|Primary|Percentage of Participants With Injection Prophylaxis Treatment|Participants received anti-pneumocystosis agents, antiviral agents, or immunoglobulins as infection prophylaxis. One participant could receive more than one infection prophylaxis treatment.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number participants analyzed= all participants having had maintenance/observation period before the first study disease progression and received infection prophylaxis treatment.|||percentage of participants|||Number
2587966|NCT02312687|Primary|Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category|Clinically significant changes from baseline reported as adverse events are presented.|Through Week 184||||Participants|||Count of Participants
2587622|NCT02316613|Primary|Percentage of Participants With Prescription of Injection Prophylaxis|Participants was prescribed with either of the following infection prophylaxis treatment: anti-pneumocystosis agents, antiviral agents, or immunoglobulins.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed=all participants having had maintenance/observation period before the first study disease progression.|||percentage of participants|||Number
2587623|NCT02316613|Primary|Duration of MabThera Maintenance Therapy When Associated With Observation|Duration of MabThera maintenance therapy was calculated from the end of induction period to the day before the first disease progression over the study (or to the date of last participant information if no disease progression until the end of the participant follow-up). Disease progression was based on the followings: Eastern Cooperative Oncology Group performance status; presence of B symptoms (fever 38°C in absence of infection for more than 8 days, night sweats, weight loss exceeding 10% in 6 months); evaluation of tumor mass (Groupe d'Etudes des Lymphomes Folliculaires criteria); number of nodal sites; number and location of extranodal sites; Ann-Arbor stage (I to IV); any histological documentation: type of biopsy (nodal, extranodal, bone marrow); histological type (progression of follicular non-Hodgkin's lymphomas or transformation); latest available hemoglobin, neutrophils, normal or leukemic lymphocytes, platelets, lactate dehydrogenase, and total gamma globulins level.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = those who received at least one infusion of MabThera and completed maintenance therapy with MabThera when associated with observation period.|||months||Full Range|Median
2587624|NCT02316613|Primary|Percentage of Participants With MabThera Maintenance Therapy and at Least One Observation Phase|After study induction period (three visits) participants entered into either of two periods: 1. period of maintenance with MabThera followed by observation or 2. period of observation/maintenance without MabThera, followed by maintenance with MabThera.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = those who received at least one MabThera infusion over the maintenance therapy period.|||percentage of participants|||Number
2587625|NCT02316613|Primary|Percentage of Participants With MabThera as Maintenance Therapy|During the maintenance period participants received four weekly infusion of MabThera.|Maintenance/observation Phase: 67.8 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= those who entered in maintenance/observation after the first induction and before the first disease progression over the study.|||percentage of participants||95% Confidence Interval|Number
2587626|NCT02316613|Primary|Percentage of Participants With Chemotherapies Prescribed Over the First Study Induction Phase|Over the first study induction phase, participants received the following chemotherapy: regimen including fludarabine; regimen including aracytine - platinum salts; cyclophosphamide/hydroxydaunorubicin/oncovin/prednisone (CHOP-like); cyclophosphamide/vincristine/prednisone (CVP); regimen including ifosfamide - etoposide; and other chemotherapy. One participant could receive more than one type of chemotherapy over the first treatment induction period.|Induction Phase: 18.7 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.|||percentage of participants|||Number
2587627|NCT02316613|Primary|Percentage of Participants With Treatments Prescribed Over the First Study Induction Phase|Over the first treatment induction period, participants received following therapies for the treatment of refractory/relapsed follicular non-Hodgkin's lymphoma: chemotherapy combined with MabThera, chemotherapy alone, MabThera monotherapy, and stem cell transplantation, radio-immunotherapy, or radiation therapy combined with any other treatment. Study induction treatment phase consists total of three visits (one before the first cycle, one halfway through therapy and one after the last cycle to evaluate response). Induction treatment duration ranged between <3 months to >6 months. Each participants may received more than one therapy.|Induction Phase: 18.7 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.|||percentage of participants|||Number
2587628|NCT02316613|Secondary|Number of Participants Who Used MabThera||Up to Induction phase (18.7 months), Maintenance phase/observation phase (67.8 months)|All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.|||participants|||Number
2587629|NCT02316613|Secondary|Overall Survival (OS)|The overall survival was defined as the time from the date of first induction treatment administration over the study to the date of participants' death or early study withdrawal. OS was calculated using Kaplan-Meier method.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.|||months||95% Confidence Interval|Median
2587630|NCT02316613|Secondary|Time to Next Treatment|Time to next treatment was calculated from the date of the end of first induction treatment administration over the study to the date of the start of next treatment after disease progression.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.|||months||95% Confidence Interval|Median
2587631|NCT02316613|Secondary|Progression Free Survival (PFS)|The PFS was defined as the time from the date of first induction treatment over the study (first treatment administration of first cycle) to the date of first disease progression or participants death or date of lymphoma transformation diagnosis.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.|||months||95% Confidence Interval|Median
2587653|NCT02316470|Secondary|GMT for Toxin B Neutralizing Antibodies|"GMT for Toxin B neutralizing antibodies (TNA) as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120* and 210~* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 0, 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||Titer||95% Confidence Interval|Geometric Mean
2587632|NCT02316613|Secondary|Percentage of Participants With Disease Characteristics at First Study Disease Progression|Disease characteristics included (tumor burden, measured from whole body computed tomography (CT) scan. Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria defined as parameters to initiate treatment in participants with untreated follicular lymphoma, grade 1,2,or 3A; having just one of the criteria justified treatment: 1. involvement of >=3 nodal sites, each with diameter of >=3 centimeter(cm); 2. any nodal/extranodal tumor mass with diameter of >=7cm; 3. B symptoms (temperature >=38 degrees celsius or night sweats or weight loss >10% over past 6 months); 4. splenomegaly; 5. pleural effusion/peritoneal ascites; 6. cytopenia (leukocytes <1×10^9 and/or platelets <100×10^9/L. One participant could present with more than 1 GELF criterion. Ann Arbor staging was used as staging system for lymphomas (Stage I to IV); stage depended upon the place where malignant tissue was located (through biopsy, CT scan, or positron emission tomography) and on systemic symptoms due to lymphoma).|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= participants with at least one disease progression over the study period. n=number of evaluable participant for each disease characteristics.|||percentage of participants|||Number
2587633|NCT02316613|Secondary|Percentage of Participants With Number of Disease Progressions|Participants with at least one disease progression after the first study induction period were reported.|Up to 6 years|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed= those participants who entered in maintenance/observation after the first induction and before the first disease progression over the study.|||percentage of participants|||Number
2587634|NCT02316613|Secondary|Percentage of Participants With Last Induction Treatment Response|Last Induction treatment response: the last response assessment over the first study induction treatment (complete response [CR]: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CR unconfirmed: CR along with regression in lymph node mass by more than [>]75% in the sum of the products of greatest diameters [SPD]; Partial Response [PR]: greater than or equal to [>=] 50% decrease in SPD of 6 largest dominant nodes or nodal masses; Progression was 1 of the following: 1) lymphadenopathy; 2) a >=50% increase in previously noted or new appearance of hepato/splenomegaly; 3) >=50% increase in blood lymphocyte count with at least 5000 B lymphocytes/μL; 4) transformation to Richter's syndrome; or 5) occurrence of cytopenia; Stable disease [SD]: absence of necessary criteria to achieve CR or PR, but no advancement to progression) was described at the end of first study induction.|Induction Phase: 18.7 months|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed (N)=number of participants evaluable for this outcome measure.|||percentage of participants|||Number
2587635|NCT02316613|Primary|Percentage of Participants With Modalities of the Therapeutic Decision Before First Study Induction Treatment Phase|"At study inclusion, the therapeutic management of participants was decided by either pluri-disciplinary consultation meeting, Only the physician in charge of the participant, Discussion between physicians, or Punctual consultation of an external physician. Percentage of participants with each of these modalities of therapeutic decision was reported."|Baseline|Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2587636|NCT02316548|Secondary|Number of Patients With Bowel Toxicity|Adverse events (AE) evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Bowel toxicity= abdominal distension/pain, colitis, colonic fistula/ hemorrhage/obstruction/perforation/stenosis/ulcer, diarrhea, enterocolitis, fecal incontinence/gastrointestinal/fistula/pain, ileal fistula/hemorrhage/obstruction/perforation/stenosis/ulcer, Ileus, jejunal fistula/hemorrhage/obstruction/perforation/stenosis/ulcer, lower gastrointestinal hemorrhage, rectal fistula/hemorrhage/mucositis/necrosis/obstruction/pain/perforation/stenosis/ulcer, small intestinal mucositis/obstruction/perforation/stenosis/ulcer, vomiting. Highest grade adverse event per subject counted. Grade refers to AE severity and ranges from 1 to 5 with unique clinical descriptions of severity for each AE based on this general guideline: 1 Mild, 2 Moderate, 3 Severe, 4 Life-threatening or disabling, 5 Death related to AE.|From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months|Randomized eligible patients with adverse event data|||Participants|||Count of Participants
2587637|NCT02316548|Secondary|Disease Free Survival (DFS)|Disease free survival (DFS) is defined as the first occurrence of either: pelvic failure, distant metastasis, or death and was to be estimated by the Kaplan-Meier method and arms compared using the log-rank test. Pelvic recurrence is specifically defined as soft tissue and /or lymph node tumor recurrence in the pelvis anywhere between the L5-S1 disc space superiorly and the pelvic floor inferiorly. This was to be determined on the basis of pelvic imaging (CT or MRI scan demonstrating soft tissue or nodal recurrence at least 1cm in linear dimension) or urethroscopy; biopsy was not required. Distant metastases is defined as any hematogenous metastases and/or lymph node metastases above the L5-S1 interspace, documented by imaging (CT and/or MRI and/or bone scans). Due to early termination with few patients, only counts of events have been calculated.|From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months|Randomized eligible patients with disease assessment data|||Participants|||Count of Participants
2587638|NCT02316548|Primary|Pelvic Recurrence-free Survival (PRFS)|PRFS is defined as time free of pelvic recurrence or death, with patients who experience distant metastasis censored at the time of occurrence. Pelvic recurrence is specifically defined as soft tissue and /or lymph node tumor recurrence in the pelvis anywhere between the L5-S1 disc space superiorly and the pelvic floor inferiorly. This was to be determined on the basis of pelvic imaging (CT or MRI scan demonstrating soft tissue or nodal recurrence at least 1cm in linear dimension) or urethroscopy; biopsy was not required. PRFS was to be tested between arms in terms of a difference in cause-specific-hazards using the log-rank test and cumulative incidence of PRFS in the presence of competing risks was to be computed via cumulative incidence. Due to early termination with few patients, only counts of events have been calculated.|From randomization to study termination, maximum follow-up was 13.3 months, median follow-up was 1.9 months|Randomized eligible patients with disease assessment data|||Participants|||Count of Participants
2587639|NCT02316470|Secondary|Rates of Study Participants With at Least One Solicited Local and Systemic AE Within 7 Days After Each and Any Vaccination Stratified by Age Group|percentage of participants with solicited (sol.) local and systemic AEs within 7 days after each and after any vaccination (vacc.), collected via a subject diary with predefined terms, stratified by age group (subjects 50 - < 65 years and 65 years and older)|within 7 Days after each vaccination|Safety Population = study participants with at least one study vaccination|||percentage of participants||95% Confidence Interval|Number
2587640|NCT02316470|Secondary|Rates of Study Participants With at Least One SAE, Related SAE, Unsolicited AE and Related Unsolicited AE Stratified by Age Group|percentage of study participants with at least one SAE, related SAE, unsolicited (unsol.) AE (incl. clinically significant laboratory parameter changes) and related unsolicited AE, starting up to Day 56 and Day 210, stratified by age group (subjects 50 - < 65 years and 65 years and older (65+))|Day 56 and Day 210|Safety Population = study participants with at least one study vaccination|||percentage of participants||95% Confidence Interval|Number
2587641|NCT02316470|Secondary|Rates of Study Participants With at Least One Solicited Local and Systemic AE|percentage of study participants with solicited local and systemic AE within 7 days after each and after any vaccination, collected via a subject diary with predefined terms|within 7 Days after each vaccination|Safety Population = study participants with at least one study vaccination|||percentage of participants||95% Confidence Interval|Number
2587642|NCT02316470|Secondary|Rate of Study Participants With at Least One Related Unsolicited AE|percentage of study participants with at least one related unsolicited AE starting up to Day 56 and Day 210 (incl. clinically significant laboratory parameter changes)|Day 56 and Day 210|Safety Population = study participants with at least one study vaccination|||percentage of participants||95% Confidence Interval|Number
2587643|NCT02316470|Secondary|Rate of Study Participants With at Least One Unsolicited AEs (Adverse Event)|percentage of study participants with at least one unsolicited AE starting up to Day 56 and Day 210 (incl. clinically significant laboratory parameter changes)|Day 56 and Day 210|Safety Population = study participants with at least one study vaccination|||percentage of participants||95% Confidence Interval|Number
2587644|NCT02316470|Secondary|Rate of Study Participants With at Least One Related SAE|percentage of study participants with at least one related SAE starting up to Day 56 and up to Day 210|Day 56 and Day 210|Safety Population = study participants with at least one study vaccination|||percentage of participants||95% Confidence Interval|Number
2587645|NCT02316470|Secondary|Rate of Study Participants With at Least One SAE (Serious Adverse Event)|percentage of study participants with at least one SAE starting up to Day 56 and up to Day 210|Day 56 and Day 210|Safety Population = study participants who received at least one study vaccination|||percentage of participants||95% Confidence Interval|Number
2587646|NCT02316470|Secondary|Responder Rate (RR) for Neutralizing Antibodies Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group|"Responder Rate for neutralizing antibodies against Toxin A (RR Tox A), against Toxin B (RR Tox B) and against both Toxin A and Toxin B (RR Tox A and B) on Days 35, 56, 120* and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older)~* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||percentage of participants||95% Confidence Interval|Number
2587647|NCT02316470|Secondary|Responder Rate (RR) for Toxin B Neutralizing Antibodies|"Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against Toxin B on Days 35, 56, 120* and 210~* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||percentage of participants||95% Confidence Interval|Number
2587648|NCT02316470|Secondary|Responder Rate (RR) for Toxin A Neutralizing Antibodies|"Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against Toxin A on Days 35, 56, 120* and 210~* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||percentage of participants||95% Confidence Interval|Number
2587649|NCT02316470|Secondary|Responder Rate (RR) for Neutralizing Antibodies Against Both Toxin A and Toxin B|"Responder Rate (RR) (defined as percentage of subjects achieving a ≥4-fold increase in neutralizing antibody titer from Day 0) for neutralizing antibodies against both Toxin A and Toxin B on Days 35, 56, 120* and 210~* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 35, 56, 120, 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||percentage of participants||95% Confidence Interval|Number
2587650|NCT02316470|Secondary|GMTs for Toxin A Neutralizing Antibodies and for Toxin B Neutralizing Antibodies Stratified by Age Group|"GMTs for Toxin A neutralizing antibodies and for Toxin B neutralizing antibodies as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120* and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older)~* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 0, 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||Titer||95% Confidence Interval|Geometric Mean
2587651|NCT02316470|Secondary|GMT for IgG Against Toxin A and Against Toxin B Stratified by Age Group|GMT for IgG against Toxin A and against Toxin B on Days 0, 14, 28, 35, 56, 120 and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older)|Days 0, 14, 28, 35, 56, 120, 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||EU/ml||95% Confidence Interval|Geometric Mean
2587652|NCT02316470|Secondary|SCR for IgG Against Toxin A, Against Toxin B and Against Both Toxin A and Toxin B Stratified by Age Group|Seroconversion Rate (SCR) for IgG against Toxin A, against Toxin B and against both Toxin A and Toxin B on Days 14, 28, 35, 56, 120 and 210, stratified by age group (subjects 50 - < 65 years and 65 years and older)|Days 14, 28, 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||percentage of participants||95% Confidence Interval|Number
2587654|NCT02316470|Secondary|GMT for Toxin A Neutralizing Antibodies|"GMT for Toxin A neutralizing antibodies (TNA) as determined by Toxin Neutralization Assay on Days 0, 35, 56, 120* and 210~* TNA in sera from Day 120 were to be measured only if meaningful in view of the Day 56 and Day 210 results; in fact Day 120 TNA was not measured."|Days 0, 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||Titer||95% Confidence Interval|Geometric Mean
2587655|NCT02316470|Secondary|Geometric Mean Titer (GMT) for IgG Against Toxin B|Geometric Mean Titer (GMT) for IgG against Toxin B as determined by ELISA on Days 0, 14, 28, 35, 56 (primary endpoint time point), 120 and 210;|Days 0, 14, 28, 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||EU/ml||95% Confidence Interval|Geometric Mean
2587656|NCT02316470|Secondary|Geometric Mean Titer (GMT) for IgG Against Toxin A|Geometric Mean Titer (GMT) for IgG against Toxin A as determined by ELISA on Days 0, 14, 28, 35, 56 (primary endpoint time point), 120 and 210;|Days 0, 14, 28, 35, 56, 120 and 210|PP210 = per protocol population defined as subjects without major protocol deviation up to Day 210|||EU/ml||95% Confidence Interval|Geometric Mean
2587657|NCT02316470|Secondary|Seroconversion Rate (SCR) for IgG Against Toxin B|Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against Toxin B;|Days 14, 28, 35, 56, 120 and 210|per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210|||percentage of participants||95% Confidence Interval|Number
2587658|NCT02316470|Secondary|Seroconversion Rate (SCR) for IgG Against Toxin A|Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against Toxin A;|14, 28, 35, 56, 120 and 210|per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210|||percentage of participants||95% Confidence Interval|Number
2587659|NCT02316470|Secondary|SCR for IgG (Immunoglobulin G) Against Both Toxin A and Toxin B|Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against both Toxin A and Toxin B on Day 14, 28, 35, 120 and 210;|Days 14, 28, 35, 120 and 210|per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210|||percentage of participants||95% Confidence Interval|Number
2587660|NCT02316470|Primary|Seroconversion Rate (SCR) on Day 56|Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against both Toxin A and Toxin B on Day 56;|Day 56|per-protocol population,i.e., subjects who received at least one study vaccination without any major protocol deviation up to Day 210|||percentage of study participants||95% Confidence Interval|Number
2587661|NCT02316366|Secondary|Global Comfort|"Upon disposition patients were asked to complete a survey which assessed their global comfort during the ED stay. Question 2 of the survey addressed comfort by asking: On a scale of 1 to 5, how do you think the fluid made you feel? (1 is worse and 5 is better)."|4 hours||||units on a scale||Inter-Quartile Range|Median
2587662|NCT02316366|Secondary|Amount of Narcotic Administered|The amount of opioid analgesic administered in the ED prior to disposition was recorded for each patient|4 hours||||mg/kg||95% Confidence Interval|Mean
2587663|NCT02316366|Secondary|Time to Disposition|The amount of time spent in the ED was recorded for each patient|4 hours||||minutes||95% Confidence Interval|Mean
2587664|NCT02316366|Secondary|Difference in Pain Score|During the ED stay, patient's pain scores on the Wong-Baker FACES scale was recorded at 30 minute intervals until disposition decided. The difference between the pain score upon arrival and at discharge was assessed. Minimum value 1, maximum value 10 (most pain)|4 hours||||units on a scale||Standard Error|Mean
2587665|NCT02316366|Primary|Rate of Hospital Admission|After being treated for pain in the Emergency Department, the disposition of the patient (whether admitted to the hospital for further care or discharge to home) was recorded.|4 hours||||percentage of participants||95% Confidence Interval|Number
2587666|NCT02316353|Secondary|Percentage of Subjects Who Are Responders|A responder was defined as a subject with a ≥ 50% reduction in the time-normalized number of HAE attacks on CSL830 relative to the time-normalized number of HAE attacks used to qualify for participation in the current study. The analysis population for this endpoint was the Intent-to-Treat (ITT) Population: The ITT Population comprised all subjects who provided informed consent / assent and were randomized, regardless of whether or not they received CSL830. Not all subjects in the ITT were available for this outcome measure.|Up to 146 weeks|Intent-to-Treat (ITT) Population: The ITT Population comprised all subjects who provided informed consent / assent and were randomized, regardless of whether or not they received CSL830.|||Percent of Subjects||95% Confidence Interval|Number
2587667|NCT02316353|Secondary|Percentage of Subjects Who Experience a Time-normalized HAE Attack Frequency of <1 HAE Attack Per 4-Week Period|The percentage of subjects with a time-normalized merged HAE attack frequency of <1 HAE attack per 4-week period. The analysis population for this endpoint was the Intent-to-Treat (ITT) Population: The ITT Population comprised all subjects who provided informed consent / assent and were randomized, regardless of whether or not they received CSL 830.|Up to 146 weeks|Intent-to-Treat (ITT) Population: The ITT Population comprised all subjects who provided informed consent / assent and were randomized, regardless of whether or not they received CSL 830.|||Percent of Subjects|||Number
2587668|NCT02316353|Secondary|Percentage of Subjects Who Become Seropositive for Human Immunodeficiency Virus (HIV-1/-2), Hepatitis B Virus, or Hepatitis C Virus.|Blood samples to be tested for HIV-1/-2, HBV, and HCV. The analysis population for this endpoint was the Safety Population: The Safety Population comprised all subjects who provided informed consent / assent, who were randomized, and who received at least 1 dose or a partial dose of CSL830.|Up to 146 weeks|Safety Population: The Safety Population comprised all subjects who provided informed consent / assent, who were randomized, and who received at least 1 dose or a partial dose of CSL830.|||Percent of Subjects|||Number
2587681|NCT02315872|Primary|Fatigue at 28 Weeks|Patient-reported levels of fatigue as measured by score on the Modified Fatigue Impact Scale (MFIS) and the Fatigue Severity Scale (FSS) at 28 weeks. The full-length MFIS consists of 21 items. A higher score on the MFIS indicates a greater impact of fatigue on a patient's activities. The FSS is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Higher scores on each scale indicate a greater severity of fatigue.|28 weeks||||score on a scale||Full Range|Median
2587669|NCT02316353|Secondary|Percentage of Injections Followed by At Least One Solicited Adverse Event|The percent of injections followed by at least one solicited adverse event. The analysis population for this endpoint was the Safety Population: The Safety Population comprised all subjects who provided informed consent / assent, who were randomized, and who received at least 1 dose or a partial dose of CSL830. This was assessed across all participants, calculated as total number of events following injections / total number of injections across all participants, in each Arm.|Up to 146 weeks|Safety Population: The Safety Population comprised all subjects who provided informed consent / assent, who were randomized, and who received at least 1 dose or a partial dose of CSL830.|||Percent of injections|||Number
2587670|NCT02316353|Secondary|Percentage of Subjects Who Have Solicited Adverse Events (AEs)|The number of subjects having at least 1 solicited local AE during a treatment were divided by the number of subjects in the corresponding treatment. The analysis population for this endpoint was the Safety Population: The Safety Population comprised all subjects who provided informed consent / assent, who were randomized, and who received at least 1 dose or a partial dose of CSL830.|Up to 146 weeks|Safety Population: The Safety Population comprised all subjects who provided informed consent / assent, who were randomized, and who received at least 1 dose or a partial dose of CSL830.|||Percent of subjects|||Number
2587671|NCT02316353|Primary|The Person-time Incidence Rates (Event Based)|Event-based Analysis for Person-Time Incidence Rate = (the total number of events documented during the respective treatment) / (the sum of each subject's end date - the subject's start date + 1 day) / (365.25 days). The analysis population for this endpoint was the Safety Population: The Safety Population comprised all subjects who provided informed consent / assent, who were randomized, and who received at least 1 dose or a partial dose of CSL830.|Up to 146 weeks.|Safety population: The Safety Population comprised all subjects who provided informed consent / assent, who were randomized, and who received at least 1 dose or a partial dose of CSL830.|||events/year|||Number
2587672|NCT02316353|Primary|Person-time Incidence Rates (Subject Based)|Subject-based Analysis for Person-Time Incidence Rate = (the total number of subjects who experienced the event during the respective treatment) / (the sum of the date each subject experienced the event - the subject's start date + 1 day) / (365.25 days). The analysis population for this endpoint was the Safety Population: the Safety Population comprised all subjects who provided informed consent / assent, who were randomized, and who received at least 1 dose or a partial dose of CSL830.|Up to 146 weeks.|Safety population: The Safety Population comprised all subjects who provided informed consent / assent, who were randomized, and who received at least 1 dose or a partial dose of CSL830.|||participants with events/year|||Number
2587673|NCT02316171|Primary|Incidence of Dose-limiting Toxicities Treatment-related Adverse Events.|Number of Participants with Treatment-emergent adverse events. The events for each cohort of dose of CVA21 only are pooled for the analysis.|30 days from last dose||||Participants|||Count of Participants
2587674|NCT02316002|Primary|Progression Free Survival (PFS)|Time to progression or death from initiation of LAT|3 years||||Months||95% Confidence Interval|Mean
2587675|NCT02315989|Secondary|Percentage of Each Target Lesion Evaluation Types.(1)Complete Response(2)Partial Response,(3)Progressive Disease,(4)Stable Disease,(5) Inevaluable|Response Evaluation Criteria In Solid Tumors:(1)complete Response(CR),Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm (2)Partial Response(PR), At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (3)Progressive Disease(PD), At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (4)Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. (5) Inevaluable (NE), Inevaluable for response: specify reasons (for example: early death, malignant disease; toxicity; tumor assessments not repeated/incomplete; other (specify).|Average 100 days after treatment.||||percentage of participants|||Number
2587676|NCT02315989|Secondary|Percentage of System Errors|During treatment, the frequency of operation of the system error will be recorded and analyzed to see if the system can run smoothly.|Average 100 days after treatment.||||percentage of system errors|||Number
2587677|NCT02315989|Primary|Rate and Severity of Adverse Reactions|After enrollment, each patient has to receive physical examination, laboratory tests, and image studies as baseline. During the course of radiotherapy, patients will have weekly evaluations in physicals and laboratory tests. Image studies are optional during treatment. In the follow-up periods, monthly exams, including regular physicals, markers in serum and urine and image studies to evaluation treatment responses, will be scheduled till 90 days after the end of treatment.|Average 90 days after treatment.||||participants|||Number
2587678|NCT02315872|Secondary|Quality of Life at 28 Weeks|Patient-reported quality of life as measured by the 36-Item Short Form Health Survey (SF-36) at 28 weeks. The SF-36 is a 36-item, patient-reported survey of patient mental and physical health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.|28 weeks||||score on a scale||Full Range|Median
2587679|NCT02315872|Secondary|Sleepiness at 28 Weeks|Patient-reported daytime sleepiness as measure by the Epworth Sleepiness Scale (ESS) at 28 weeks. The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'.|28 weeks||||score on a scale||Full Range|Median
2587680|NCT02315872|Secondary|Depression at 28 Weeks|Patient-reported depression as measured by the Beck Depression Inventory-II (BDI-II) at 28 weeks. The BDI-II is a 21-item self-report multiple-choice inventory used as an indicator of the severity of depression. A higher score indicates a greater severity of depression.|28 weeks||||score on a scale||Full Range|Median
2587682|NCT02315755|Secondary|Correlation Coefficient Between Efficacy and High Blood Pressure (>150 / 90 Millimeter of Mercury )||Baseline up to Month 12 follow-up visit|Analysis was performed on all enrolled participants.|||Correlation coefficient|||Number
2587684|NCT02315755|Secondary|Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events|Number of participants that required dose modifications of third line treatment due to AEs were reported in this outcome measure. Dose modification was categorized as escalation (increase in dose), delay or interruptions (change in dose time or skipping any dose), reduction (decrease in dose).|Baseline up to Month 3, 6, 9 and 12|Analysis was performed on all enrolled participants. Here, “Number analyzed, indicates participants evaluable for specified category”.|||Participants|||Count of Participants
2587685|NCT02315755|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) During Third Line Targeted Treatment|An AE was any untoward medical occurrence in a participant who received disease treatment without regard to possibility of causal relationship. Treatment emergent AEs during third line targeted treatment were events which occurred between first dose of third line targeted treatment and up to Month 12 follow-up visit, that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 12 months|Analysis was performed on all enrolled participants.|||Participants|||Count of Participants
2587686|NCT02315755|Secondary|Number of Participants With Grade 3 or Higher Severe Adverse Events (AEs) Based on NCI CTCAE Version 4.03|An AE was any untoward medical occurrence in a participant who received disease treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were graded according to the National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and coded using the Medical Dictionary for Regulatory Activities (MedDRA) as Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life threatening, Grade 5: Death related to AE. AEs included both SAEs and non-SAEs.|Baseline up to 12 months|Analysis was performed on all enrolled participants.|||Participants|||Count of Participants
2587687|NCT02315755|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received disease treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs were events which occurred between start of disease treatment and up to Month 12 follow-up visit, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both non-SAE and SAEs.|Baseline up to 12 months|Analysis was performed on all enrolled participants.|||Participants|||Count of Participants
2587688|NCT02315755|Secondary|Time to Treatment Failure|Time to treatment failure was defined as the time from the start of treatment to the date of disease progression or date of permanent discontinuation. PD as per RECIST version 1.1 was defined as at least a 20% increase in the sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%.|Baseline until disease progression or discontinuation, due to any cause (up to 33 months)|Analysis was performed on all enrolled participants. Here, “overall number of participants analysed”, indicates participants evaluable for this outcome measure.|||months||Full Range|Median
2587689|NCT02315755|Secondary|Overall Survival at Year 1: Percentage of Participants Who Survived at Year 1|Overall survival at Year 1 (Month 12) was defined as the time from the start of 3rd line treatment until death or 1 year due to any cause (measured at the end of 12 month follow-up/observation period). Percentage of participants who survived at the completion of 1 year (12 months) period were reported in this outcome measure.|Baseline until death due to any cause (up to 1 year)|Analysis was performed on all enrolled participants.|||percentage of participants|||Number
2587690|NCT02315755|Secondary|Overall Survival|Overall survival was defined as the time from the start of 3rd line treatment until date of death due to any cause.|From the start of 3rd line treatment until death due to any cause (up to a maximum of 33 months)|Analysis was performed on all enrolled participants.|||months||Full Range|Median
2587691|NCT02315755|Primary|Change From Baseline in FKSI-DRS Score at Last Follow-up|FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.|Baseline (Day 1 of Month 1), last follow up visit (up to 33 months)|Analysis was performed on all enrolled participants. Here, “overall number of participants analysed”, indicates participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2587692|NCT02315755|Primary|Change From Baseline in FKSI-DRS Score at Month 9|FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.|Baseline (Day 1 of Month 1), Month 9|Analysis was performed on all enrolled participants. Here, “overall number of participants analysed”, indicates participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2587693|NCT02315755|Primary|Change From Baseline in FKSI-DRS Score at Month 6|FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.|Baseline (Day 1 of Month 1), Month 6|Analysis was performed on all enrolled participants. Here, “overall number of participants analysed”, indicates participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2587694|NCT02315755|Primary|Change From Baseline in FKSI-DRS Score at Month 3|FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.|Baseline (Day 1 of Month 1), Month 3|Analysis was performed on all enrolled participants. Here, “overall number of participants analysed”, indicates participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2587695|NCT02315755|Primary|Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease-Related Symptoms (FKSI-DRS) Score at Baseline|FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.|Baseline (Day 1 of Month 1)|Analysis was performed on all enrolled participants. Here, “overall number of participants analysed”, indicates participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2587696|NCT02315755|Primary|Change From Baseline in EQ5D-3L Score at Last Follow-up|"EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with 1 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems."|Baseline (Day 1 of Month 1), last follow up visit (up to 33 months)|Analysis was performed on all enrolled participants. Here, “overall number of participants analysed”, indicates participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2587697|NCT02315755|Primary|Change From Baseline in EQ5D-3L Score at Month 9|"EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with 1 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems."|Baseline (Day 1 of Month 1), Month 9|Analysis was performed on all enrolled participants. Here, “overall number of participants analysed”, indicates participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2587698|NCT02315755|Primary|Change From Baseline in EQ5D-3L Score at Month 6|"EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with 1 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems."|Baseline (Day 1 of Month 1), Month 6|Analysis was performed on all enrolled participants. Here, “overall number of participants analysed”, indicates participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2587699|NCT02315755|Primary|Change From Baseline in EQ5D-3L Scores at Month 3|"EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with 1 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems."|Baseline (Day 1 of Month 1), Month 3|Analysis was performed on all enrolled participants. Here, “overall number of participants analysed”, indicates participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2587700|NCT02315755|Primary|EuroQol-5 Dimension-3 Level (EQ5D-3L) Scores at Baseline|"EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The mean of the summed score ranged from 1 to 3 with 1 corresponding to no problems and 3 corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems. Total index EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best)."|Baseline (Day 1 of Month 1)|Analysis was performed on all enrolled participants. Here, “overall number of participants analysed”, indicates participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2587701|NCT02315755|Primary|Change From Baseline in FKSI-15 Score at Last Follow-up|FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.|Baseline (Day 1 of Month 1), last follow-up visit (up to 33 months)|Analysis was performed on all enrolled participants. Here, “overall number of participants analysed”, indicates participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2587711|NCT02315664|Secondary|KOOS - Activity of Daily Living|Activity of Daily Living was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.|Baseline; 2 months, 4 months and 6 months from baseline|The number of participants analyzed is the same as the number of participants assigned to each group.|||score on a scale||Standard Deviation|Mean
2601724|NCT02150837|Secondary|Waist Circumference|Waist circumference expressed as an absolute change from baseline.|12 weeks|Not all subjects remaining at 12 weeks had measurement performed.|||Inches||Standard Deviation|Mean
2587702|NCT02315755|Primary|Change From Baseline in FKSI-15 Score at Month 9|FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.|Baseline (Day 1 of Month 1), Month 9|Analysis was performed on all enrolled participants. Here, “overall number of participants analysed”, indicates participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2587703|NCT02315755|Primary|Change From Baseline in FKSI-15 Score at Month 6|FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.|Baseline (Day 1 of Month 1), Month 6|Analysis was performed on all enrolled participants. Here, “overall number of participants analysed”, indicates participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2587704|NCT02315755|Primary|Change From Baseline in FKSI-15 Score at Month 3|FKSI was used to assess QoL of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.|Baseline (Day 1 of Month 1), Month 3|Analysis was performed on all enrolled participants. Here, “overall number of participants analysed”, indicates participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2587705|NCT02315755|Primary|Functional Assessment of Cancer Therapy Kidney Symptom Index - 15 (FKSI-15) Score at Baseline|FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.|Baseline (Day 1 of Month 1)|Analysis was performed on all enrolled participants. Here, “overall number of participants analysed”, indicates participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2587706|NCT02315755|Primary|Percentage of Participants With Overall Objective Response|Overall objective response was defined as the percentage of participants with best confirmed response (partial response [PR], stable disease [SD] or progressive disease [PD]) recorded from the start of the study treatment until the end of treatment as assessed by RECIST version 1.1. PR defined as a 30% or more decrease in the sum of longest dimensions of the target lesions, taking as reference the baseline sum of longest dimensions. PD defined as at least a 20% increase in the sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference to the smallest sum diameters while on study.|Baseline until the maximum of 33 months|Analysis was performed on all enrolled participants.|||percentage of participants|||Number
2587707|NCT02315755|Primary|Progression Free Survival (PFS)|PFS was defined as the time duration (in months) during and after the treatment of disease that a participant lived with the disease but it did not get worse or progressed. Progressive disease as per response evaluation criteria in solid tumors (RECIST) version 1.1 defined as at least a 20 percent (%) increase in the sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions or increase of at least 5 millimeter (mm) in addition to the relative increase of 20%.|From the start of disease treatment until disease progression or death due to any cause (up to a maximum of 33 months)|Analysis was performed on all enrolled participants.|||months||95% Confidence Interval|Median
2587708|NCT02315664|Secondary|Partners in Health Scale|The Partners in Health Scale is a 12-item measure designed to assess self-efficacy, knowledge of health conditions and treatment, and self-management behaviors such as adopting a healthy lifestyle. Scores range from 0 to 96, with lower being better.|Baseline; 2 months, 4 months and 6 months from baseline|The number of participants analyzed is the same as the number of participants assigned to each group.|||score on a scale||Standard Deviation|Mean
2587709|NCT02315664|Secondary|KOOS - Quality of Life|Quality of Life was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.|Baseline; 2 months, 4 months and 6 months from baseline|The number of participants analyzed is the same as the number of participants assigned to each group.|||score on a scale||Standard Deviation|Mean
2587710|NCT02315664|Secondary|KOOS - Sports & Recreation|Sports & Recreation was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.|Baseline; 2 months, 4 months and 6 months from baseline|The number of participants analyzed is the same as the number of participants assigned to each group.|||score on a scale||Standard Deviation|Mean
2587728|NCT02315261|Secondary|Duration Retaining Epidural Catheter|Duration retaining epidural catheter in hospital|the period of retaining of epidural catheter up to 3 days after operation||||hours||95% Confidence Interval|Mean
2587712|NCT02315664|Secondary|KOOS - Pain|Pain was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.|Baseline; 2 months, 4 months and 6 months from baseline|The number of participants analyzed is the same as the number of participants assigned to each group.|||score on a scale||Standard Deviation|Mean
2587713|NCT02315664|Secondary|KOOS - Symptoms|Symptoms were measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.|Baseline; 2 months, 4 months and 6 months from baseline|The number of participants analyzed is the same as the number of participants assigned to each group.|||score on a scale||Standard Deviation|Mean
2587714|NCT02315664|Secondary|Time Spent in Sedentary Behaviors|We calculated the average daily time spent with an energy expenditure of 1.5 METs or lower, occurring in bouts of 20 minutes or more during waking hours.|Change from baseline in time spent sedentary behaviors at 2 months, 4 months, and 6 months.|The number of participants analyzed is the same as the number of participants assigned to each group.|||Minutes per day||Standard Deviation|Mean
2587715|NCT02315664|Primary|Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)|Participants wore a SenseWear Mini accelerometer for 7 days at baseline, and Months 2, 4, and 6. We calculated the average daily time (minutes) spent in MVPA accumulated in bouts. A bout is defined as 10 or more consecutive minutes at the level of 3 or higher METs, with allowance for interruption of up to 1 minute below the threshold.|Baseline; 2 months, 4 months and 6 months from baseline|The number of participants analyzed is the same as the number of participants assigned to each group.|||Minutes per day||Standard Deviation|Mean
2587716|NCT02315560|Secondary|Quality of Life Questionnaire Scores|The NLUTD/DES questionnaire (Neurogenic Lower Urinary Tract Dysfunction/Dysfunctional Elimination Syndrome) has been validated and is reliable for assessing lower urinary tract and bowel dysfunction. The questionnaire is scored using a 5-point Likert scale. The questionnaire consists of a total of 14 questions, each question asking about a symptom. Question #7 specifically addresses nocturnal enuresis. A score of 4 indicates severe symptoms, while a score of 0 indicates none. The maximum score is 52, indicating the most severe symptoms, while the minimum score of zero indicates zero symptoms. Scores of 11 or greater indicate bladder or bowel dysfunction.|6 weeks||||units on a scale||Full Range|Mean
2587717|NCT02315560|Primary|Decrease in Nocturnal Enuresis|To determine if foot stimulation can decrease nocturnal enuresis in children as measured by daily night-time voiding log. The outcome is the number of participants that had a clinical response with improvement of at least 1 wet night reduction during the 6-week stimulation period.|6 weeks||||Participants|||Count of Participants
2587718|NCT02315430|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, up to 20.1 months.|Eligible and Treated Patients|||Months||90% Confidence Interval|Median
2587719|NCT02315430|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1|Tumor scan done every 8 weeks during treatment, Average progression free survival was 3.6 months.|Eligible and Treated Patients|||months||90% Confidence Interval|Mean
2587720|NCT02315430|Secondary|Number of Participants With Grade 3 or Higher Adverse Events|Grade 3 or higher adverse events were graded by CTC AE v 4.|Every cycle while on treatment, up to 30 days after treatment ends, an average of 14 months.|Eligible and Treated Patients|||participants|||Number
2587721|NCT02315430|Primary|Objective Tumor Response|Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Every 8 weeks during treatment;assessed up to 20 months.|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2587722|NCT02315430|Primary|The Percentage of Patients Who Survive Progression Free for at Least 6 Months|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Every 8 weeks during treatment, assessesd up to 6 months for progression free survival.|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2587723|NCT02315352|Secondary|Number of Subjects With Discomfort or Observations Relating to Acceptance of the Study Medication||2-5 minutes|The Safety Set (SAF) included all enrolled subjects who received at least 1 dose of any study drug.|||Subjects|||Number
2587724|NCT02315352|Secondary|Number of Subjects With Mouth Feeling and Taste Description Evaluation|"Mouth feeling was described in terms of sweet, bitter, sticky or smooth as per the experience of the subject with the trial medication."|2-5 minutes (After the IMP has been spat out)|The data for this outcome measure could not be evaluated as data were not collected according to protocol.||||||
2587725|NCT02315352|Secondary|Overall Palatability VAS Score at 2-5 Minutes|Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability.|2-5 minutes (After the IMP has been spat out)|The Safety Set (SAF) included all enrolled subjects who received at least 1 dose of any study drug.|||units on a scale||Standard Deviation|Mean
2587726|NCT02315352|Primary|Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP])|Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability.|0 minute (Right After the Spit-out of the IMP)|The Safety Set (SAF) included all enrolled subjects who received at least 1 dose of any study drug.|||units on a scale||Standard Deviation|Mean
2587727|NCT02315261|Secondary|All Adverse Effects and Postoperative Complications.|All Adverse Effects and Postoperative Complications included the number of patients having postoperative nausea and vomiting; hypotension; accidental dural puncture and post-dural puncture headache.|the period of retaining of epidural catheter up to 3 days after operation||||participants|||Number
2587729|NCT02315261|Secondary|Number of Patients Requiring Rescue Analgesic Medication|Number of patients requiring at least one rescue analgesic medication including epidural catheter, oral and intravenous route after the operation|during the period of retaining of epidural catheter up to 3 days after operation||||Participants|||Count of Participants
2587730|NCT02315261|Primary|Number of Patients Reporting Postoperative Verbal Rating Scale Pain at Rest More Than 7|"Verbal Rating Scale Pain will routinely be assessed at postoperative 24 hours by the ward nurse.~Minimum and maximum scores possible are 0 and 10. The higher values represent patients having more pain. Severe pain is defined as Verbal Rating Scale pain at rest more than 7."|at postoperative 24 hours||||Participants|||Count of Participants
2587731|NCT02314936|Other Pre-specified|Number of Subjects With Adverse Events|Adverse events were recorded in a daily diary during the 14-day run-in period and the 14-day treatment period. All types of adverse events as well as the total number of all adverse events reported were used in this outcome measure.|14 days run-in and 14 days treatment|The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).|||Number of Adverse Events|||Number
2587732|NCT02314936|Other Pre-specified|Change in pH Urinalysis Parameter From Baseline to Day 15|Safety will be evaluated by measuring urine analyses (specifically urine pH in this outcome measure). Urine pH reference range is between 5.0 - 8.0, with no alerting or critical values.|Screening and Day 15 (end of study)|One participant from the 12 g polydextrose arm, one participant from the 8 g polydextrose arm, and three participants from the 4 g polydextrose arm were unable to have urinalysis parameters analysed.|||pH||Standard Deviation|Mean
2587733|NCT02314936|Other Pre-specified|Change in Specific Gravity Urinalysis Parameter From Screening to Day 15|Safety will be evaluated by measuring urine analyses (specifically specific gravity in this outcome measure). The reference range for specific gravity are 1.001 - 1.030 mmol/L, with no alerting or critical values.|Screening and Day 15 (end of study)|One participant from the 12 g polydextrose arm, one participant from the 8 g polydextrose arm, and three participants from the 4 g polydextrose arm were unable to have urinalysis parameters analysed.|||mmol/L||Standard Deviation|Mean
2587734|NCT02314936|Other Pre-specified|Change in Serum C-Reactive Protein Concentration From Baseline to Day 15|Safety will be evaluated by measuring blood serum variables (specifically C-reactive protein concentration in this outcome measure).|Screening and Day 15 (end of study)||||mg/L||Standard Deviation|Mean
2587735|NCT02314936|Other Pre-specified|Change in Serum Gamma-Glutamyltransferase Concentration From Baseline to Day 15|Safety will be evaluated by measuring blood serum variables (specifically gamma-glutamyltransferase concentration in this outcome measure).|Screening and Day 15 (end of study)||||U/L||Standard Deviation|Mean
2587736|NCT02314936|Other Pre-specified|Change in Serum Alkaline Phosphate Concentration From Baseline to Day 15|Safety will be evaluated by measuring blood serum variables (specifically alkaline phosphate concentration in this outcome measure).|Screening and Day 15 (end of study)||||U/L||Standard Deviation|Mean
2587737|NCT02314936|Other Pre-specified|Change in Serum Alanine Transaminase Concentration From Baseline to Day 15|Safety will be evaluated by measuring blood serum variables (specifically alanine transaminase concentration in this outcome measure).|Screening and Day 15 (end of study)||||U/L||Standard Deviation|Mean
2587738|NCT02314936|Other Pre-specified|Change in Serum Aspartate Transaminase Concentration From Baseline to Day 15|Safety will be evaluated by measuring blood serum variables (specifically aspartate transaminase concentration in this outcome measure).|Screening and Day 15 (end of study)||||U/L||Standard Deviation|Mean
2587739|NCT02314936|Other Pre-specified|Change in Serum Bilirubin Concentration From Baseline to Day 15|Safety will be evaluated by measuring blood serum variables (specifically bilirubin concentration in this outcome measure).|Screening and Day 15 (end of study)||||μmol/L||Standard Deviation|Mean
2587740|NCT02314936|Other Pre-specified|Change in Serum Phosphate Concentration From Baseline to Day 15|Safety will be evaluated by measuring blood serum variables (specifically phosphate concentration in this outcome measure).|Screening and Day 15 (end of study)||||mmol/L||Standard Deviation|Mean
2587741|NCT02314936|Other Pre-specified|Change in Serum Carbon Dioxide Concentration From Baseline to Day 15|Safety will be evaluated by measuring blood serum variables (specifically carbon dioxide concentration in this outcome measure).|Screening and Day 15 (end of study)|One participant in the Litesse powder containing 4 g polydextrose arm did not have this blood serum variable analysed due to laboratory analysis error.|||mmol/L||Standard Deviation|Mean
2587742|NCT02314936|Other Pre-specified|Change in Serum Calcium Concentration From Baseline to Day 15|Safety will be evaluated by measuring blood serum variables (specifically calcium concentration in this outcome measure).|Screening and Day 15 (end of study)||||mmol/L||Standard Deviation|Mean
2587743|NCT02314936|Other Pre-specified|Change in Serum Chloride Concentration From Baseline to Day 15|Safety will be evaluated by measuring blood serum variables (specifically chloride concentration in this outcome measure).|Screening and Day 15 (end of study)||||mmol/L||Standard Deviation|Mean
2587744|NCT02314936|Other Pre-specified|Change in Serum Potassium Concentration From Baseline to Day 15|Safety will be evaluated by measuring blood serum variables (specifically potassium concentration in this outcome measure).|Screening and Day 15 (end of study)|One participant in the Litesse powder containing 4 g polydextrose arm did not have this blood serum variable analysed due to laboratory analysis error.|||mmol/L||Standard Deviation|Mean
2587745|NCT02314936|Other Pre-specified|Change in Serum Sodium Concentration From Baseline to Day 15|Safety will be evaluated by measuring blood serum variables (specifically sodium concentration in this outcome measure).|Screening and Day 15 (end of study)||||mmol/L||Standard Deviation|Mean
2587746|NCT02314936|Other Pre-specified|Change in Serum Estimated Globular Filtration Rate From Baseline to Day 15|Safety will be evaluated by measuring blood serum variables (specifically estimated glomerular filtration rate in this outcome measure).|Screening and Day 15 (end of study)||||mL/min/1.73m^2||Standard Deviation|Mean
2587747|NCT02314936|Other Pre-specified|Change in Serum Urea Concentration From Baseline to Day 15|Safety will be evaluated by measuring blood serum variables (specifically urea concentration in this outcome measure).|Screening and Day 15 (end of study)||||mmol/L||Standard Deviation|Mean
2587748|NCT02314936|Other Pre-specified|Change in Creatinine Levels in Blood From Baseline to Day 15|Safety will be evaluated by measuring blood serum variables (specifically creatinine concentration in this outcome measure).|Screening and Day 15 (end of study)||||μmol||Standard Deviation|Mean
2587749|NCT02314936|Other Pre-specified|Change in Serum Glucose Concentration From Baseline to Day 15|Safety will be evaluated by measuring blood serum variables (specifically glucose concentration in this outcome measure).|Screening and Day 15 (end of study)|The number analyzed from the Litesse powder 4g arm is only 47 due to laboratory analysis error.|||mmol/L||Standard Deviation|Mean
2587750|NCT02314936|Other Pre-specified|Change in Basophil Count From Baseline to Day 15|Safety will be evaluated by measuring whole blood hematology (specifically basophil count in this outcome measure).|Screening and Day 15 (end of study)|Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).|||10^9 cells/L||Standard Deviation|Mean
2587751|NCT02314936|Other Pre-specified|Change in Eosinophil Count From Baseline to Day 15|Safety will be evaluated by measuring whole blood hematology (specifically eosinophil count in this outcome measure).|Screening and Day 15 (end of study)|Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).|||10^9 cells/L||Standard Deviation|Mean
2587752|NCT02314936|Other Pre-specified|Change in Monocyte Count From Baseline to Day 15|Safety will be evaluated by measuring whole blood hematology (specifically monocyte count in this outcome measure).|Screening and Day 15 (end of study)|Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).|||10^9 cells/L||Standard Deviation|Mean
2587753|NCT02314936|Other Pre-specified|Change in Lymphocyte Count From Baseline to Day 15|Safety will be evaluated by measuring whole blood hematology (specifically lymphocyte count in this outcome measure).|Screening and Day 15 (end of study)|Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).|||10^9 cells/L||Standard Deviation|Mean
2587754|NCT02314936|Other Pre-specified|Change in Neutrophil Count From Baseline to Day 15|Safety will be evaluated by measuring whole blood hematology (specifically neutrophil count in this outcome measure).|Screening and Day 15 (end of study)|Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).|||10^9 cells/L||Standard Deviation|Mean
2587755|NCT02314936|Other Pre-specified|Change in Platelet Count From Baseline to Day 15|Safety will be evaluated by measuring whole blood hematology (specifically platelet count in this outcome measure).|Screening and Day 15 (end of study)|Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).|||10^9 cells/L||Standard Deviation|Mean
2587756|NCT02314936|Other Pre-specified|Change in Red Cell Distribution Width From Baseline to Day 15|Safety will be evaluated by measuring whole blood hematology (specifically red cell distribution width in this outcome measure).|Screening and Day 15 (end of study)|Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).|||percent of mean red blood cell volume||Standard Deviation|Mean
2587757|NCT02314936|Other Pre-specified|Change in Mean Corpuscular Hemoglobin Concentration From Baseline to Day 15|Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular hemoglobin concentration in this outcome measure).|Screening and Day 15 (end of study)|Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).|||g/dL||Standard Deviation|Mean
2587758|NCT02314936|Other Pre-specified|Change in Mean Corpuscular Hemoglobin From Baseline to Day 15|Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular hemoglobin in this outcome measure).|Screening and Day 15 (end of study)|Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).|||pg||Standard Deviation|Mean
2587759|NCT02314936|Other Pre-specified|Change in Mean Corpuscular Volume From Baseline to Day 15|Safety will be evaluated by measuring whole blood hematology (specifically mean corpuscular volume in this outcome measure).|Screening and Day 15 (end of study)|Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).|||fL||Standard Deviation|Mean
2587760|NCT02314936|Other Pre-specified|Change in Red Blood Cell Count From Baseline to Day 15|Safety will be evaluated by measuring whole blood hematology (specifically red blood cell count in this outcome measure).|Screening and Day 15 (end of study)|Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).|||10^12 cells/L||Standard Deviation|Mean
2587761|NCT02314936|Other Pre-specified|Change in White Blood Cell Count From Baseline to Day 15|Safety will be evaluated by measuring whole blood hematology (specifically white blood cell count in this outcome measure).|Screening and Day 15 (end of study)|Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).|||10^9 cells/L||Standard Deviation|Mean
2587762|NCT02314936|Other Pre-specified|Change in Hematocrit Levels From Screening to Day 15|Safety will be evaluated by measuring the change in whole blood hematology (specifically hematocrit levels in this outcome).|Screening and Day 15 (end of study)|Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).|||Percentage of red blood cells||Standard Deviation|Mean
2587967|NCT02312687|Primary|Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category|Clinically significant changes from baseline reported as adverse events are presented.|Through Week 184||||Participants|||Count of Participants
2587763|NCT02314936|Other Pre-specified|Change in Hemoglobin Levels From Baseline to Day 15|Safety will be evaluated by measuring whole blood hematology (specifically hemoglobin in this outcome).|Screening and Day 15 (end of study)|Whole blood hematology was not obtained from two participants (one participant in the Litesse powder containing 12 g polydextrose arm and one participant in the Litesse powder containing 4 g polydextrose).|||g/dL||Standard Deviation|Mean
2587764|NCT02314936|Secondary|Overall Product Satisfaction|"Participants will be asked to rate their overall satisfaction with the study product's ability to relieve their constipation symptoms on a 5-point ordinal scale.~The overall product satisfaction questionnaire consists of a single question that provides insight regarding the participants satisfaction on the product's ability to relieve constipation symptoms. The score that the participant indicates is considered the total score and no sub-scores are calculated. It is a rating scale that ranges from 1 (not at all satisfied) to 5 (very satisfied) where a higher score at the end-of-study indicates an improvement."|Assessed at Day 15 (end of study)|The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).|||scores on a scale||Standard Deviation|Mean
2587765|NCT02314936|Secondary|Change in the Bloating Severity From Baseline to Day 15|"Severity of bloating will be recorded each day in a daily diary on a 5-point scale.~The severity of abdominal bloating was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of bloating where a lower score represented less straining."|14 day run-in and Week 2 of the 14-day supplementation period|The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).|||scores on a scale||Standard Deviation|Mean
2587766|NCT02314936|Secondary|Change in the Severity of Abdominal Discomfort From Baseline to Day 15|"Severity of abdominal discomfort will be recorded each day in a daily diary on a 5-point scale.~The severity of abdominal discomfort was calculated from a rating scale ranging from 1 (not at all) to 5 very severe); a single score was recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of discomfort where a lower score represented less straining."|14 day run-in and Week 2 of the 14-day supplementation period|The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).|||scores on a scale||Standard Deviation|Mean
2587767|NCT02314936|Secondary|Change in the Sensation of Complete Bowel Emptying From Baseline to Day 15|"Sensation of complete bowel emptying for each bowel movement will be recorded in a daily diary on a dichotomous yes or no scale.~The change in the sensation was defined as the change from baseline to week 2 in the percentage of complete bowel movements (CBMs) between participants supplemented with Litesse and those supplemented with a placebo. It assessed whether the participant felt as though their bowel movement was complete. The units of analysis for the sensation of complete bowel emptying was the weekly percentage of complete bowel movements, for each participant at run-in (week -1), week 1 and week 2."|14 day run-in and Week 2 of the 14-day supplementation period|The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).|||Percentage of CBMs per week||Standard Deviation|Mean
2587768|NCT02314936|Secondary|Change in the Degree of Straining During Defecation From Baseline to Day 15|"Degree of straining for each bowel movement will be recorded in a daily diary using a 5-point scale.~The degree of straining is a rating scale ranging from 1 (not at al) to 5 (an extreme amount) that interprets the degree to which an individual must strain during a unique defecation; a single core is recorded and used for analysis. Scores were calculated as the weekly average of the daily degree of straining (1-5) where a lower score represented less straining."|14 day run-in and Week 2 of the 14-day supplementation period|The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).|||scores on a scale||Standard Deviation|Mean
2587769|NCT02314936|Secondary|Change in Stool Consistency From Baseline to Day 15|"Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form.~Bristol Stool Scale:~The BSS is a categorical scale ranging from 1 to 7 that interprets the consistency of a single bowel movement; a single score is recorded and used for analysis. Lower scores are associated with hard and lumpy consistencies while higher scores are associated with soft or liquid consistencies. Generally, an optimal BSS scores ranges from 3 to 5."|14 day run-in and Week 2 of the 14-day supplementation period|The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).|||scores on a scale||Standard Deviation|Mean
2587770|NCT02314936|Secondary|Change in Stool Frequency From Baseline to Day 15|Participants will record the number of defecations per day in a daily diary|14 day run-in and Week 2 of the 14-day supplementation period|The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).|||Number of Bowel Movements Per Day||Standard Deviation|Mean
2587789|NCT02314598|Secondary|Additional Abnormal Electrogram Characteristics|Identify additional characteristics in the Far-field Electrograms that may halp to identify patients at risk of a high voltage lead failure|1 month|There were no patients with a high voltage lead failure, therefore the additional characteristics cannot be identified.||||||
2587771|NCT02314936|Secondary|Change in Adequate Relief of Constipation Symptoms From Baseline to Day 15|"Assessed using single question dichotomous tool.~Adequate relief quantified the difference in the number of participants experiencing relief from constipation between participants supplemented with Litesse and those supplemented with a placebo at baseline and day 14. The units of analysis for the relief questionnaire were the number of participants who reported relief from constipation."|Baseline and Day 15|The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).|||Participants|||Count of Participants
2587772|NCT02314936|Secondary|Change in Bowel Function Index From Baseline to Day 15|"Assessed using the Bowel Function Index questionnaire (total score, ease of defecation, feeling of incomplete bowel evacuation, and personal judgement of constipation).~Each of the three questions used a numerical analog scale (0 = easy/no difficulty/not at all, 100 = very strong/very difficult) for grading purposes. The three questions were calculated as single scores as well as by a total score defined as the average of the three questions."|Baseline and Day 15|The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).|||scores on a scale||Standard Deviation|Mean
2587773|NCT02314936|Secondary|Change in Participant Assessment of Constipation Quality of Life (PAC-QoL) From Baseline to Day 15|"Assessed using the PAC-QoL questionnaire (Overall Score, Worries and Concerns Score, Physical Discomfort Score, Psychosocial Discomfort Score, and Satisfaction Score)~The Patient Assessment of Constipation (PAC) was developed to address the need for a disease-specific patient-reported outcomes measure. It includes components from complementary symptom and quality of life questionnaires.~The PAC-QOL contains 28 items grouped into 4 subscales covering: worries and concerns (11 items), physical discomfort (4 items), psychosocial discomfort (8 items), and satisfaction (5 items).~A 5-point Likert response scale, ranging from 0 (not at all / none of the time) to 4 (extremely / all of the time), where lower scores are better. Scores are computed as the average non-missing item response within the subscale where each score is given equal weight; the global score is calculated as the mean of the 28-items."|Baseline and Day 15|The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).|||scores on a scale||Standard Deviation|Mean
2587774|NCT02314936|Secondary|Change in Participant Assessment of Constipation Symptoms (PAC-SYM) From Baseline to Day 15|"Assessed using the PAC-SYM questionnaire (overall score, abdominal symptoms score, rectal symptoms score, and stool symptoms score).~The PAC-SYM was developed as a brief, easily administered tool to assess symptom frequency and severity of chronic constipation. The authors used a definition for constipation was based on the Rome II criteria. This 12-item self-report measure is divided into the 3 symptom subscales of: abdominal, rectal and stool subscales.~All items (sub-scores and the total score) are scored on a five-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe) where lower scores are better. Scores for the total number of non-missing items within the subscale or total score are summed and divided by the total number of non-missing items for that subscale or total score."|Baseline and Day 15|The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).|||scores on a scale||Standard Deviation|Mean
2587775|NCT02314936|Primary|Change in Colonic Transit Time From Baseline to Day 15|Assessed using abdominal x-ray. Subjects will take 24 radiopaque markers for 6 consecutive days (144 radiopaque markers in total) immediately preceding the x-ray dates.|Baseline and Day 15|The number of participants analysed is the number of participants who met the per protocol population requirement. 17 participants did not meet the per protocol compliance (must have consumed ≥80% of assigned study product and 100% of radio opaque pellets) and 2 participants did not complete the study (did not complete end-of-study visit).|||Hours||Standard Deviation|Mean
2587776|NCT02314923|Primary|Optimum Dose for General Use Prophylaxis With V920|The optimum dose for general use prophylaxis with V920 was determined following the review of all immunogenicity and safety data.|Day 360|All participants who received study vaccine|||pfu|||Number
2587777|NCT02314923|Secondary|Percentage of Participants With Seroconversion for ZEBOV Neutralizing Antibodies|Blood was drawn on Days 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days to assess the GMTs of Zaire ebolavirus neutralizing antibodies as determined plaque reduction neutralization titer (reciprocal of the dilution that resulted in a 60% decrease in plaques) (PRNT60).|7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days postvaccination|All participants who were vaccinated, had endpoint titer results on Days 0 (baseline) and 28 (relative Days 24-35), and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints. A subset of 25 placebo recipients in Cohort 1 were prospectively identified for testing of immunogenicity endpoints.|||Percentage of Participants|||Number
2587778|NCT02314923|Secondary|Percentage of Participants With Seroconversion for ZEBOV-specific IgG|Blood was drawn on Days 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days to assess the GMTs via ELISA. Seroconversion was defined as a post-vaccination titer ≥ 200 ELISA Units/mL that was also at least a 4-fold increase in titer compared to baseline.|7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days postvaccination|All participants who were vaccinated, had endpoint titer results on Days 0 (baseline) and 28 (relative Days 24-35), and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints. A subset of 25 placebo recipients in Cohort 1 were prospectively identified for testing of immunogenicity endpoints.|||Percentage of Participants|||Number
2587790|NCT02314598|Secondary|Proportion of Patients With Abnormal Electrograms and Lead Failure|Compare the proportion of patients with abnormal electrograms (e.g. high frequency spike) and a high voltage lead failure within 1 month to those patients with abnormal electrograms and no lead failure within 1 month|1 month|There were no patients with a high voltage lead failure, therefore the proportions cannot be estimated nor compared.||||||
2587779|NCT02314923|Secondary|Mean Copies of Vector Ribonucleic Acid (RNA) for Participants With a V920 Polymerase Chain Reaction (PCR) Result ≥ Lower Limit of Quantification (LLOQ)|Participants had blood, assessed for evidence of V920 via polymerase chain reaction (PCR). Mean copies of RNA was reported for all participants who had reading ≥ the LLOQ (62.5 copies/mL)|Days 1, 2, 3, 4, 7, 14 and 28 post-vaccination|All participants who were vaccinated, had endpoint titer results on Days 0 (baseline) and 28 (relative Days 24-35), and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints. A subset of 25 placebo recipients in Cohort 1 were prospectively identified for testing of immunogenicity endpoints.|||copies/mL||Standard Deviation|Geometric Mean
2587780|NCT02314923|Primary|Geometric Mean Titers (GMTs) of Zaire Ebola Virus- (ZEBOV)-Specific Immunoglobulin-G (IgG) Antibody|Blood was drawn on Day 28 to assess the GMTs of ZEBOV-specific IgG antibodies as determined by Enzyme-linked immunosorbent assay (ELISA).|28 days postvaccination|All participants who were vaccinated, had endpoint titer results on Days 0 (baseline) and 28 (relative Days 24-35), and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints. A subset of 25 placebo recipients in Cohort 1 were prospectively identified for testing of immunogenicity endpoints.|||ELISA Units/mL||Standard Deviation|Geometric Mean
2587781|NCT02314923|Primary|Percentage of Participants With One or More Serious Adverse Event (SAE) by Severity|An adverse event is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An SAE is an AE that results in death, is life-threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. SAEs were assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening; 5=Fatal. The percentage of participants that experienced at least 1 SAE was summarized by grade.|Up to 360 days postvaccination|All randomized participants who received study vaccination and had data available for the endpoint.|||Percentage of Participants|||Number
2587782|NCT02314923|Primary|Percentage of Participants With One or More Unsolicited Vaccine-related Adverse Event by Severity|An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Unsolicited vaccine-related AEs were those events not specifically listed as either an injection-site (local) or systemic in the VRC and were reported as at least possibly related to the study vaccine or placebo. The AEs were further assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The percentage of participants that experienced at least one unsolicited vaccine-related AE was summarized by grade..|Up to 56 days postvaccination|All randomized participants who received study vaccination and had data available for the endpoint.|||Percentage of Participants|||Number
2587783|NCT02314923|Primary|Percentage of Participants With One or More Solicited Systemic Adverse Events by Severity|An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Systemic AEs included subjective and objective fever, shivering/chills, sweats, myalgia, arthralgia, joint swelling, joint tenderness, fatigue, headache, gastrointestinal symptoms (nausea, vomiting, abdominal pain, and diarrhea), mucosal lesion, and skin lesion (including any blisters). AEs were assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The percentage of participants that experienced at least one systemic AE was summarized by grade.|Up to 14 days postvaccination|All randomized participants who received study vaccination and had data available for the endpoint.|||Percentage of Participants|||Number
2587784|NCT02314923|Primary|Percentage of Participants With One or More Solicited Injection-site Adverse Events by Severity|An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, tenderness and swelling. AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The percentage of participants that experienced at least 1 solicited injection-site AE was summarized by grade.|Up to 14 days postvaccination|All randomized participants who received study vaccination and had data available for the endpoint.|||Percentage of Participants|||Number
2587785|NCT02314689|Primary|Number of Participants With Grade 2 or Higher Adverse Event According to NCI Criteria||12 months||||participants|||Number
2587786|NCT02314637|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 52||Baseline and Week 52|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.|||mg/dL||Standard Deviation|Mean
2587787|NCT02314637|Secondary|Change From Baseline in HbA1c at Week 52||Baseline and Week 52|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after the treatment of study drug. Analysis based on last observation carried forward, where the last postbaseline observed value was carried forward and used for Week 52 where data was missing.|||percent||Standard Deviation|Mean
2587788|NCT02314637|Primary|Number of Participants With Adverse Events|Treatment-emergent adverse events (TEAE) were defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after receiving the last dose of study drug.|52 weeks|Safety set, consisting of all patients, who received at least one dose of study drug and who had at least one safety data after the treatment of study drug.|||participants|||Number
2587791|NCT02314598|Primary|Number of Patients With Abnormal Electrograms During a Lead Issue|Number of patients with at least one instance of abnormal noise during recording. Electrograms will be collected during 24 hours and afterwards abnormalities in the electrograms will be visually identified.|24 hours|"46 subjects were enrolled and completed the study. All subjects met the inclusion and exclusion criteria.~5 subjects were excluded since they did not have an Holter recording with at least 12 hours of telemetry."|||Participants|||Count of Participants
2587792|NCT02314546|Secondary|Verbal Complaints|Recorded by the administering RN at one minute post-administration|1 minute post-administration||||participants|||Number
2587793|NCT02314546|Secondary|Verbal Complaint|Recorded by the administering RN at the time of administration.|At time of administration||||participants|||Number
2587794|NCT02314546|Secondary|RN Observed Behavioral Distress Score|Measured by the administering RN using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible).|1 minute post-administration||||units on a scale||Standard Deviation|Mean
2587795|NCT02314546|Secondary|Parental Observed Behavioral Distress Score|Measured by the accompanying parent using a Visual Analog Scale. The scale ranges from a minimum score of 0 (no distress at all) to a maximum of 10 (most distress possible).|1 minute post-administration||||units on a scale||Standard Deviation|Mean
2587796|NCT02314546|Primary|Time From Administration to Discharge||Minutes from administration to discharge||||minutes||Standard Deviation|Mean
2587797|NCT02314546|Primary|Sedation Scale Score|Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.|15 minutes post-sedation|participants with available data at this time point|||participants|||Number
2587798|NCT02314546|Primary|Sedation Scale Score|Measured by the administering RN. Measured as: agitated, alert, calm, drowsy, asleep.|10 minutes post-sedation|participants with available data at this time point|||participants|||Number
2587799|NCT02314520|Secondary|Number of Participants With a Central Line Associated Blood Stream Infection|A Central access associated infection (CLABSI)|up to 10 weeks||||Participants|||Count of Participants
2587800|NCT02314520|Secondary|Number of Patients With Complications Related to Insertion|Any complication of insertion including technical failure|From the time of insertion until first confirmatory chest X-ray||||Participants|||Count of Participants
2587801|NCT02314520|Secondary|Number of Participants With Deep Venous Thrombosis||up to 10 weeks||||Participants|||Count of Participants
2587802|NCT02314520|Primary|Participants With Complications With Central Access Including Insertion|Aggregation of all complications associated with central access including insertion|up to 10 weeks||||Participants|||Count of Participants
2587803|NCT02314260|Secondary|Cut Off Value for Bishop Score|the value at which there a high sensitivity and specificity to predict failed labour induction|5 months|sensitivity of 83% & specificity was 73% to failed induction|||probability|||Number
2587804|NCT02314260|Secondary|Cut Off Value for The Modified Bishop Score|the value at which there a high sensitivity and specificity to predict failed labour induction|5 months|sensitivity of 83% and a specificity of 87% for failed induction.|||probability|||Number
2587805|NCT02314260|Secondary|Area Under Curve for The Bishop Score|to predict failed induction and comparing it to the area under curve for modified bishop score to find out which test is more accurate in predicting caesarean section, The positive actual state is failed induction and performing Caesarean Section. The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity), So as the numbers approaches 1, induction fails, the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).|5 months|The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction of labour fails, the Y-axis of the curve is (sensitivity) and the x- axis is (1-specificity).|||probability||95% Confidence Interval|Number
2587806|NCT02314260|Primary|Area Under Receiver Operating Characteristic Curve (ROC) for Modified Bishop Score|to predict failed induction and comparing it to the area under curve for bishop score to find out which test is more accurate in predicting caesarean section, The positive actual state is failed induction and performing Caesarean Section.The positive actual state is failed induction, the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity). So as the numbers approaches 1, induction fails, the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).|5 months|the area under the modified bishop score was 0.916 (95% [confidence interval ] 0.85–0.97). The positive actual state is failed induction and performing Caesarean Section, So as the numbers approaches 1, induction fails, the Y-axis of the curve is sensitivity and the x- axis is (1-specificity).|||probability||95% Confidence Interval|Number
2587807|NCT02314247|Secondary|Progression Free Survival (PFS)|Duration of time from start of study treatment to date of disease progression or death from any cause.|Study treatment start date to date of disease progression or date of death. Patients without documented PD are censored on date of last radiologic assessment.|Intent to Treat population.|||Days||95% Confidence Interval|Median
2587808|NCT02314247|Secondary|Disease Control Rate (DCR)|Percentage of patients who have CR, PR, or SD lasting ≥ 8 weeks. Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment.|Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression.|Intent to Treat (ITT) Population|||Percentage of participants||80% Confidence Interval|Number
2587818|NCT02314143|Secondary|Number of Participants With On-treatment Serious Adverse Events (SAEs) and Non-SAEs|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function.|Up to 3.2 years|Safety Population|||Participants|||Count of Participants
2587809|NCT02314247|Secondary|Duration of Stable Disease, Including Patients With Partial Response|Duration of time from the date of start of study treatment to the date of disease progression. Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment.|Date of start of study treatment to date of progression. Patients without documented PD are censored on date of last radiologic assessment.|Those participants with stable disease, including those with partial response, as a subset of the Intent to Treat (ITT) population|||Days||95% Confidence Interval|Median
2587810|NCT02314247|Primary|Best Overall Response: Not Evaluable (NE)|Patients who could not be assessed quantitatively for disease response for any reason.|Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression.|Intent to Treat population|||Participants|||Count of Participants
2587811|NCT02314247|Primary|Best Overall Response: Progressive Disease (PD)|Patients whose best overall response to study treatment was PD. Progression was defined as the first occurrence of progressive disease (PD). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. Clinical disease progression in the absence of formal criteria for PD must be documented by a physician.|Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression.|Intent to Treat population|||Participants|||Count of Participants
2587812|NCT02314247|Primary|Best Overall Response: Stable Disease (SD)|Patients whose best overall response to study treatment was SD (failure to attain criteria needed for CR or PR, or to meet criteria for PD). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment.|Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression.|Intent to Treat population|||Participants|||Count of Participants
2587813|NCT02314247|Primary|Best Overall Response: Partial Response (PR)|Patients whose best overall response to study treatment was PR (regression of measurable disease and no new sites). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment.|Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression.|Intent to Treat (ITT) population|||Participants|||Count of Participants
2587814|NCT02314247|Primary|Best Overall Response: Complete Response (CR)|Patients who achieved CR (disappearance of all detectable evidence of disease). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment.|Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression.|Intent to Treat population|||Participants|||Count of Participants
2587815|NCT02314247|Primary|Overall Response Rate (ORR)|Overall Response (OR) = Complete Response (CR) + Partial Response (PR). Objective disease response assessment in PTCL patients was made according to the revised response criteria based on the International Working Group (IWG) guidelines for malignant lymphoma (Cheson, 2007). Objective disease response assessment in CTCL patients was assessed according to the revised CTCL Consensus Response Criteria (Olsen, 2011) using physical examination, including the Modified Severity Weighted Assessment Tool (mSWAT) for skin assessment. CTCL Global Response Score was used as a secondary efficacy assessment. Progression was defined as the first occurrence of progressive disease (PD) per the revised response criteria. Clinical disease progression in the absence of formal criteria for PD must be documented by a physician.|Disease response was assessed at screening and every 8 weeks (patients with PTCL); or at Cycle 1 Day 1 and every 4 weeks (patients with CTCL), until disease progression.|Due to the limited enrollment in this study, only the Intent to Treat (ITT) Population, consisting of all patients who received at least 1 dose of study treatment (which is identical to the Safety Population), was evaluated for efficacy.|||Percentage of participants||80% Confidence Interval|Number
2587816|NCT02314143|Secondary|Plasma Pharmacokinetic Concentration of Dabrafenib|Blood samples were collected for pharmacokinetic analysis of Dabrafenib at indicated time points. Pharmacokinetic analysis was performed using standard non-compartmental method.|4 to 8 hours post-dose at Weeks 2, 8 and 10|Biomarker Population. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|||Nanograms per milliliter||Standard Deviation|Mean
2587817|NCT02314143|Secondary|Plasma Pharmacokinetic Concentration of Trametinib|Blood samples were collected for pharmacokinetic analysis of trametinib at indicated time points. Pharmacokinetic analysis was performed using standard non-compartmental method.|4 to 8 hours post-dose at Weeks 2, 8 and 10|Biomarker Population. Only those participants with data available at specific time point were analyzed (represented by n=x in category titles).|||Nanograms per milliliter||Standard Deviation|Mean
2587819|NCT02314143|Secondary|Number of Participants With Incidence of Squamous Cell Carcinoma and Keratoacanthoma|The safety profile of dabrafenib and trametinib in monotherapy as well as in combination therapy was characterized by determining the number of participants with incidence of squamous cell carcinoma and keratoacanthoma.|Up to 3.2 years|Safety Population|||Participants|||Count of Participants
2587820|NCT02314143|Secondary|Number of Participants With Change in Hematology Parameters From Baseline|Blood samples were collected for evaluation of hematology parameters including hemoglobin, white blood cell (WBC), platelet count, basophils, eosinophils, lymphocytes, monocytes, total neutrophils, lymphocytopenia and lymphocytosis. Baseline was defined as the most recent non-missing value from a central laboratory prior to the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The worst-case on therapy value for number of participants with any grade increase in hematology parameters for has been presented.|Baseline and up to 3.2 years|Safety Population|||Participants|||Count of Participants
2587821|NCT02314143|Secondary|Number of Participants With Change in Clinical Chemistry Parameters From Baseline|Blood samples were collected for evaluation of clinical chemistry parameters including sodium, potassium, calcium, albumin, total protein, blood urea nitrogen (BUN), creatinine, lactate dehydrogenase (LDH), gamma-glutamyl transpeptidase (GCT), phosphate, C-reactive protein (CRP), hypercalcemia, hyperkalemia, hypernatremia, hypocalcemia, hypokalemia, hyponatremia, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, direct bilirubin and estimated creatinine clearance (CRTCE). Baseline was defined as the most recent non-missing value from a central laboratory prior to the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The worst-case on therapy value for number of participants with any grade increase in clinical chemistry parameters for has been presented. Only those participants available at specified time point were analyzed (represented by n=x in category titles).|Baseline and up to 3.2 years|Safety Population|||Participants|||Count of Participants
2587822|NCT02314143|Secondary|Number of Participants With Absolute Change in Left Ventricular Ejection Fraction From Baseline|Echocardiograms (ECHO) was performed to assess cardiac ejection fraction and cardiac valve morphology. Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The worst-case on-therapy value has been presented.|Baseline and up to 3.2 years|Safety Population|||Participants|||Count of Participants
2587823|NCT02314143|Secondary|Number of Participants With Abnormal Electrocardiograms (ECG) Findings|Single measurements of 12-lead ECGs were obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, corrected QT interval (QTc), Bazett's Corrected QT interval (QTcB), Friderica's Corrected QT interval (QTcF). Number of participants with abnormal ECG findings (Abnormal - Not Clinically Significant and Abnormal - Clinically Significant ) at any time post-Baseline visit have been presented.|Up to 3.2 years|Safety Population|||Participants|||Count of Participants
2587824|NCT02314143|Secondary|Number of Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Scores From Baseline|The ECOG scale of performance status describes the level of functioning of participants in terms of their ability to care for themselves, daily activity, and physical ability. The ECOG performance was recorded as per ECOG performance status grades ranging from 0 (fully active, able to carry on all pre-disease performance without restriction) to 5 (dead). Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The Baseline performance status of participants with respect to worst-case on-therapy performance status has been presented.|Baseline and up to 3.2 years|Safety Population|||Participants|||Count of Participants
2587825|NCT02314143|Secondary|Number of Participants With Clinically Significant Abnormal Findings Undergoing Physical Examinations|Complete physical examination included assessments of eyes, neurological and cardiovascular systems, lungs, abdomen, and any other areas with signs and symptoms of disease, and of the head, neck, ears, nose, mouth, throat, thyroid, lymph nodes, extremities, and a full skin exam to assess cutaneous malignancies and proliferative skin diseases. This analysis was planned but data was not captured in the database. Abnormal changes were captured as adverse events if they were clinically significant.|Up to 3.2 years|Safety Population. This analysis was planned but data was not captured in the database.||||||
2587826|NCT02314143|Secondary|Number of Participants With Change in Vital Signs From Baseline|"Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heat rate (HR) were measured. Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. Change from Baseline was defined as any visit value minus the Baseline value. The number of participants with heart rate decrease to < 60 and increase to >100 have been presented. For SBP and DBP, any grade increase have been presented. Any grade increase in SBP, including grade 0 (<120), grade 1 (120-139), grade 2 (140-159), grade 3 (>=160) and DBP including grade 0 (<80), grade 1 (80-89), grade 2 (90-99), grade 3 (>=100) have been presented. The analysis was based on the Safety Population which included all participants who received at least one dose of randomized treatment and was based on the actual treatment received. Only those participants available at specified time point were analyzed (represented by n=x in category titles)."|Baseline and up to 3.2 years|Safety Population|||Participants|||Count of Participants
2587827|NCT02314143|Secondary|Number of Participants With Overall Response Rate (ORR)|Clinical response was evaluated by ORR, which was defined as the number of participants with a confirmed or an unconfirmed complete response (CR) or partial response (PR) at any time per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. CR was defined as disappearance of all target lesions. PR was defined as at least a 30 percent decrease in the sum of the diameters of target lesions. Number of participants with ORR (CR+PR) has been presented. The analysis was based on the Intent-to-Treat Population (ITT) which included all the randomized participants whether or not randomized treatment was administered.|Up to 3.2 years|Intent-to-Treat Population (ITT)|||Participants|||Count of Participants
2587847|NCT02314104|Primary|Postoperative Pain on a Visual Analogue Pain Scale at One Hour Postoperatively|A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.|one hour postoperatively||||units on a scale||Standard Deviation|Mean
2587968|NCT02312687|Primary|Number of Participants With Clinically Significant Changes From Baseline in Vital Signs|Clinically significant changes from baseline reported as adverse events are presented.|Through Week 184||||Participants|||Count of Participants
2587828|NCT02314143|Primary|Number of Participants With Percentage Change in p-ERK H Score From Week 8 to Week 10|Intra-tumoral expression levels of ERK were measured using immunohistochemistry methods. The H score value ranged from 0 to a maximum score of 300 (strongest expression) was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0 [no staining], 1+ [weak staining], 2+ [medium staining] and 3+ [strongest staining]). Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. Percentage change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplied by 100. The data has been presented for dabrafenib followed by combination therapy and trametinib followed by combination therapy, calculated from Week 8 to Week 10.|Week 8 and up to 10 weeks|Biomarker Population. Only those participants with data available at specific time point were analyzed.|||Participants|||Count of Participants
2587829|NCT02314143|Primary|Number of Participants With Percentage Change From Baseline in Extracellular Signal-regulated Kinase (ERK) Phosphorylation (p-ERK) H Score From Week 0 to Week 2|Intra-tumoral expression levels of ERK measured using immunohistochemistry methods. The H score value ranged from 0 to a maximum score of 300 (strongest expression) was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0 [no staining], 1+ [weak staining], 2+ [medium staining] and 3+ [strongest staining]). Baseline was defined as the most recent non-missing value prior to the first dose of study treatment. Percentage change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplied by 100. The data has been presented for combination therapy calculated from Week 0 to Week 2. The analysis was based on the biomarker Population which included all participants with biopsy performed at screening and at least once during treatment.|Baseline (Week 0) and up to 2 weeks|Biomarker Population. Only those participants with data available at specific time point were analyzed.|||Participants|||Count of Participants
2587830|NCT02314117|Secondary|PK: Minimum Concentration (Cmin) of Ramucirumab|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab|Cycle 1 Day 1: 1 hour (hr) end of infusion (EOI), Cycle 3 Day 1: 1hr EOI, Cycle 9 Day 1: 1 hr EOI|All randomized participants who received ramucirumab and had evaluable PK data|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2587831|NCT02314117|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Ramucirumab|Pharmacokinetics (PK): Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Ramucirumab|Cycle 1 Day 1: 1 hour (hr) end of infusion (EOI), Cycle 3 Day 1: 1hr EOI, Cycle 9 Day 1: 1 hr EOI|All randomized participants who received ramucirumab and had evaluable PK data.|||Microgram/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2587832|NCT02314117|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|Participants who developed treatment-emergent antibody responses to Ramucirumab postbaseline.|Predose Cycle 1 through 30 Days After Treatment Discontinuation (Up To 24 Months)|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2587833|NCT02314117|Secondary|Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|The time from the date of randomization to the first date observing ECOG PS ≥2 (that is, deterioration from baseline status of 0 or 1). Participants without PS deterioration were censored at their last documented assessments of 0 or 1. ECOG Performance Status: 2- Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours, 3 -Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4 -Completely disabled. Cannot carry on any selfcare.Totally confined to bed or chair,5- Dead.|Randomization to ECOG PS ≥2 (Up To 26 Months)|All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=254 and Placebo + Cisplatin + Capecitabine= 260.|||months||95% Confidence Interval|Median
2587834|NCT02314117|Secondary|Change in Health Status on the EuroQol 5-Dimensions 5-Level Instrument (EQ-5D- 5L)|The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions of health status are each assessed with 5 response options and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.|Randomization, 30 Days After Treatment Discontinuation (Up To 5 Months)|All randomized participants who provided data at baseline and cycle 6.|||units on a scale||Standard Deviation|Mean
2587835|NCT02314117|Secondary|Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale|Time to sustained deterioration was defined as time from randomization to first worsening in QoL with no subsequent non-worsened assessment. Worsening in global health status/QoL was defined as a decrease of ≥10 points on a 100-point scale. If a participant did not report worsening, time to sustained deterioration was censored at date of last non-worsened assessment.|Randomization, First worsening in QoL (Up To 26 Months)|All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=215 and Placebo + Cisplatin + Capecitabine=217|||months||95% Confidence Interval|Median
2587836|NCT02314117|Secondary|Duration of Response (DoR)|Participants achieved an objective response if they had a best overall response of CR or PR.Target lesions- CR:Disappearance of all lesions;any pathological lymph nodes must have reduction in short axis to <10 mm.PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum.PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study(the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s).Non target lesions - CR: Disappearance of all lesions and normalization of tumour marker levels;all lymph nodes must be non-pathological in size. Non-CR/Non-PD:Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels.PD:Unequivocal progression of existing lesions or the appearance of new lesion(s).If a participant was not known to have died or have radiographically documented PD as of the data inclusion cutoff date,DOR was censored at the date of the last adequate tumor assessment.|Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up To 26 Months)|All randomized participants. Participants censored : Ramucirumab + Cisplatin + Capecitabine= 23 and Placebo + Cisplatin + Capecitabine=10.|||months||95% Confidence Interval|Median
2588024|NCT02311478|Secondary|Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Method Satisfaction and Continuation at 6 Months Post Insertion.|Determine rates of continuation and level of satisfaction with the IUD during the first 6 months of use.|6-month post insertion||||percent of patients|||Number
2587837|NCT02314117|Secondary|Time to Progression (TTP)|TTP was time from the date of randomization to the date of radiographic progression (according to RECIST v.1.1). If a participant died due to any reason without radiographic progression, TTP is censored at the last adequate tumor assessment. Target lesions: Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions: PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).|Randomization to Disease Progression (Up To 24 Months)|All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=149 and Placebo + Cisplatin + Capecitabine=111.|||months||95% Confidence Interval|Median
2587838|NCT02314117|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])|DCR was the percentage of participants with a best overall response of CR, PR, or SD as per Response using RECIST v1.1 criteria. Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).|Randomization to Disease Progression (Up To 26 Months)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2587839|NCT02314117|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1).Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).ORR calculated as:(sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.|Randomization to Disease Progression (Up To 26 Months)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2587840|NCT02314117|Secondary|Progression- Free Survival 2 (PFS2)|PFS2 was defined as the time from the date of randomization to second disease progression (defined as objective radiological or symptomatic progression), or death of any cause, whichever occurs first. Participants alive and for whom a second disease progression has not been observed (including participants who did not receive any additional systemic anticancer treatments) were censored at the last time known to be alive and without second disease progression. The second progression refers to disease progression on or after additional systemic anticancer therapy, regardless if any earlier progression is observed or not(e.g. at the end of study treatment). It is assessed by investigator based on overall clinical evaluation, not limited to RECIST.|Randomization to Second Radiological or Symptomatic Disease Progression After the Start of Additional Systemic Anticancer Treatment or Death from Any Cause (Up To 26 Months)|All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=74 and Placebo + Cisplatin + Capecitabine=74.|||months||95% Confidence Interval|Median
2587841|NCT02314117|Secondary|Overall Survival (OS)|OS was time from the date of randomization to the date of death from any cause. If the participant was alive at the cutoff for analysis (or was lost to follow-up), OS data were censored for analysis on the last date the participant was known to be alive.|Randomization to Death from Any Cause (Up To 30 Months)|All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=87 and Placebo + Cisplatin + Capecitabine=88.|||months||95% Confidence Interval|Median
2587842|NCT02314117|Primary|Progression-free Survival (PFS)|PFS time was measured from the date of randomization to the date of radiographic(rgr) documentation of progression(by RECIST v.1.1) or the date of death due to any cause, whichever was earlier.If a participant did not have a complete baseline tumor assessment,then the PFS time was censored at the randomization date.If a participant was not known to have died or have rgr documented progression as of the data cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. If death or progressive disease(PD) occurred after 2 or more consecutive missing rgr visits,censoring occurred at the date of the last rgr visit prior to the missed visits.If death or PD occurred after postdiscontinuation(pdis) systemic anticancer therapy,censoring occurred at the date of last rgr visit prior to the start of pdis systemic anticancer therapy. PD was defined according to RECIST v.1.1.|Randomization to Radiological Disease Progression or Death from Any Cause (Up to 26 Months)|First 508 randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=87 and Placebo + Cisplatin + Capecitabine=62.|||months||95% Confidence Interval|Median
2587843|NCT02314104|Secondary|Total Narcotic Usage in Morphine Equivalents||up to twenty-four hours postoperatively||||mg||Standard Deviation|Mean
2587844|NCT02314104|Secondary|Time Until First Request for Pain Medication||up to twenty-four hours postoperatively||||minutes||Inter-Quartile Range|Median
2587845|NCT02314104|Primary|Postoperative Pain on a Visual Analogue Pain Scale at Twenty-four Hours Postoperatively|A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.|twenty-four hours postoperatively|Arm 1: one subject discharged prior to obtaining 24 hour pain score Arm 2: one subject discharged prior to obtaining 24 hour pain score Arm 3: four subjects discharged prior to obtaining 24 hour pain score|||units on a scale||Standard Deviation|Mean
2587846|NCT02314104|Primary|Postoperative Pain on a Visual Analogue Pain Scale at Six Hours Postoperatively|A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.|six hours postoperatively|Arm 2: 6 hour pain score not obtained on one subject Arm 3: 6 hour pain score not obtained on one subject|||units on a scale||Standard Deviation|Mean
2587848|NCT02314052|Secondary|AUClast (hr*ng/mL) - DCR-MYC Levels in Blood (Phase 1b Only): Dosing Day 1 and Day 8|Samples to be collected Week 1 (Day 1, 2, and 4) and Week 2 (Day 8 and 11). A summary of outcome measures reported here are noncompartmental PK parameters (Cmax, dose-normalized Cmax (Cmax_D), Tmax, AUClast, and dose-normalized AUClast (AUClast_D)) for both infusion days (Day 1 and Day 8).|Week 1 Day 1 AND Week 2 Day 8 Cycle PK Sampling Points: 0 min, 1/4 through infusion, 1/2 through infusion, end of infusion, 15 min, 30 min, 1h, 2h, 4h, 6h, 8h, 24h, Day 4||||hr*ng/mL||Standard Deviation|Mean
2587849|NCT02314052|Secondary|AUClast_D (hr*kg*ng/mL/mg) - DCR-MYC Levels in Blood (Phase 1b Only): Dosing Day 1 and Day 8|Samples to be collected Week 1 (Day 1, 2, and 4) and Week 2 (Day 8 and 11). A summary of outcome measures reported here are noncompartmental PK parameters (Cmax, dose-normalized Cmax (Cmax_D), Tmax, AUClast, and dose-normalized AUClast (AUClast_D)) for both infusion days (Day 1 and Day 8).|Week 1 Day 1 AND Week 2 Day 8 Cycle PK Sampling Points: 0 min, 1/4 through infusion, 1/2 through infusion, end of infusion, 15 min, 30 min, 1h, 2h, 4h, 6h, 8h, 24h, Day 4||||hr*kg*ng/mL/mg||Standard Deviation|Mean
2587850|NCT02314052|Secondary|Cmax_D (kg*ng/mL/mg) - DCR-MYC Levels in Blood (Phase 1b Only): Dosing Day 1 and Day 8|Samples to be collected Week 1 (Day 1, 2, and 4) and Week 2 (Day 8 and 11). A summary of outcome measures reported here are noncompartmental PK parameters (Cmax, dose-normalized Cmax (Cmax_D), Tmax, AUClast, and dose-normalized AUClast (AUClast_D)) for both infusion days (Day 1 and Day 8).|Week 1 Day 1 AND Week 2 Day 8 Cycle PK Sampling Points: 0 min, 1/4 through infusion, 1/2 through infusion, end of infusion, 15 min, 30 min, 1h, 2h, 4h, 6h, 8h, 24h, Day 4||||kg*ng/mL/mg||Standard Deviation|Mean
2587851|NCT02314052|Secondary|Tmax (Hr) - DCR-MYC Levels in Blood (Phase 1b Only): Dosing Day 1 and Day 8|Samples to be collected Week 1 (Day 1, 2, and 4) and Week 2 (Day 8 and 11). A summary of outcome measures reported here are noncompartmental PK parameters (Cmax, dose-normalized Cmax (Cmax_D), Tmax, AUClast, and dose-normalized AUClast (AUClast_D)) for both infusion days (Day 1 and Day 8).|Week 1 Day 1 AND Week 2 Day 8 Cycle PK Sampling Points: 0 min, 1/4 through infusion, 1/2 through infusion, end of infusion, 15 min, 30 min, 1h, 2h, 4h, 6h, 8h, 24h, Day 4||||hr||Standard Deviation|Mean
2587852|NCT02314052|Secondary|DCR-MYC Biological Activities (Phase 1b Only)|Tumor biopsies (2 total) to be performed in Phase 1b MTD expansion cohort only (6 patients). Patients will have biopsies performed prior to Cycle 1/Day 1 and on Cycle 2/Day 11.|Cycle 1 and 2|Planned expansion into the MTD biopsy cohort and phase 2 portion of the study did not occur due to the sponsor's decision to prematurely end the study.||||||
2587853|NCT02314052|Secondary|DCR-MYC Biological Activities (Phase 1b Only)|Collection of blood samples for cytokine measurements (Day 1, 2, and 4). No noteworthy increases were observed across dose groups or time for GM-CSF, IFNα, IFNɣ, or IL-1β. Changes that were observed for the other cytokines were not dose-dependent since they occurred sporadically and primarily in Cohorts 3 (0.3 mg/kg) and 4 (0.45 mg/kg). Pre-dose, 4 hours post-dose, and 24 hour post-dose results for TNF-α, IL-10, IL-6, IL-8, IL-1RA, and MCP-1 are summarized here.|Cycle 1; Week 1|Safety population|||pg/mL||Standard Deviation|Mean
2587854|NCT02314052|Secondary|Cmax (ng/mL) - DCR-MYC Levels in Blood (Phase 1b Only): Dosing Day 1 and Day 8|Samples to be collected Week 1 (Day 1, 2, and 4) and Week 2 (Day 8 and 11). A summary of outcome measures reported here are noncompartmental PK parameters (Cmax, dose-normalized Cmax (Cmax_D), Tmax, AUClast, and dose-normalized AUClast (AUClast_D)) for both infusion days (Day 1 and Day 8).|Week 1 Day 1 AND Week 2 Day 8 Cycle PK Sampling Points: 0 min, 1/4 through infusion, 1/2 through infusion, end of infusion, 15 min, 30 min, 1h, 2h, 4h, 6h, 8h, 24h, Day 4||||ng/mL||Standard Deviation|Mean
2587855|NCT02314052|Primary|Phase 2: Preliminary Antitumor Activity|Up to 30 patients in the Phase 2 MTD Expansion Cohort (to be treated at the MTD identified in Phase 1b); evaluation for evidence of objective response or disease stabilization.|After Cycle 2 (6 weeks), then at 6 week intervals if DCR-MYC is continued|N/A - Study terminated prior to phase 2||||||
2587856|NCT02314052|Primary|Phase 2: Patients With Adverse Events as a Measure of Safety and Tolerability|Up to 30 patients in the Phase 2 MTD Expansion Cohort (to be treated at the MTD identified in Phase 1b); further evaluation of safety and tolerability.|Cycle 1 (3 weeks), longer if DCR-MYC is continued; with 30 days follow-up after last dose|N/A - Study terminated prior to Phase 2||||||
2587857|NCT02314052|Primary|Phase 1b: Number of Patients With Adverse Events as a Measure of Safety and Tolerability|"Part A: 3 patient cohorts with 50% dose increase between cohorts until study drug-related dose-limiting toxicity (DLT) during Cycle 1, then expand to 6 patients and move to Part B.~Part B: 3 to 6 patient cohorts with 25% dose increase between cohorts until > 1 study drug-related DLT, then stop escalation.~Expand MTD cohort to 12 patients; tumor biopsies to be performed in this Phase 1b MTD Biopsy Cohort (6 patients)."|Cycle 1 (3 weeks), longer if DCR-MYC is continued; with 30 days follow-up after last dose|Safety population|||Participants|||Count of Participants
2587858|NCT02314026|Other Pre-specified|Number of Participants With Adverse Events|A phone call will be made to each subject 48 hours after the last breath test to confirm that no adverse events related to breath test have been experienced.|48 hours from last breath test||||Participants|||Count of Participants
2587859|NCT02314026|Primary|Liver Decompensation as Measured by Area Under Receiver Operating Curve|Observe if breath tests correlate to clinical outcome of liver decompensation, including ascites, variceal bleeding, hepatic encephalopathy and spontaneous bacterial peritonitis.|36 months||||Probability||95% Confidence Interval|Number
2587860|NCT02314026|Primary|Number of Participants With Biopsy Proven Non-Alcoholic Steatohepatitis|Non-Alcoholic Steatohepatitis (NASH) as determined by liver biopsy histology will be the comparator|30 days|Subjects that had a valid biopsy and performed both Octanoate and Methacetin Breath test|||Participants|||Count of Participants
2587861|NCT02314000|Primary|Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline|Proportion of subjects with 50% or greater reduction in overall pain intensity from baseline with supra and sub perception amplitude with no increase in average daily medication intake to treat pain|90 days post activation|Due to the nature of crossover study design, all subjects contributed towards each arm, as reflected in the number of participants.|||Participants|||Count of Participants
2587895|NCT02313233|Secondary|Maximum Flow Rate (Qmax)|It's used to determine the degree of urinary difficulty.|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), 5 subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben XL 4 mg QD for BPH treatment.|||ml/ sec||Standard Deviation|Mean
2587862|NCT02313909|Secondary|Incidence Rate of Intracranial Hemorrhage|Intracranial hemorrhage included all bleeding events that occurred in intracerebral, sub arachnoidal as well as subdural or epidural sites. The below table displays results for all randomized participants and the outcomes at or after randomization until the efficacy cut-off date. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.|From randomization until the efficacy cut-off date (median 326 days)|Intention-to-treat analysis set included all randomized participants. Participants who were evaluable for this measure at given time period for the arm were included in the category.|||event/100 participant-years||95% Confidence Interval|Number
2587863|NCT02313909|Secondary|Incidence Rate of Clinically Relevant Non-Major Bleeding Events|Non-major clinically relevant bleeding was defined as non-major overt bleeding but required medical attention (example: hospitalization, medical treatment for bleeding), and/or was associated with the study drug interruption of more than 14 days. The results were based on the outcome events at or after randomization until the efficacy cut-off date. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.|From randomization until the efficacy cut-off date (median 326 days)|Intention-to-treat analysis set included all randomized participants. Participants who were evaluable for this measure at given time period for the arm were included in the category.|||event/100 participant-years||95% Confidence Interval|Number
2587864|NCT02313909|Secondary|Incidence Rate of Life-Threatening Bleeding Events|Life-threatening bleeding was defined as a subset of major bleeding that met at least one of the following criteria: 1) fatal bleeding; 2) symptomatic intracranial haemorrhage; 3) reduction in hemoglobin of at least 5 g/dl (50 g/l; 3.10 mmol/L); 4) transfusion of at least 4 units of packed red cells or whole blood; 5) associated with hypotension requiring the use of intravenous inotropic agents; 6) necessitated surgical intervention. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.|From randomization until the efficacy cut-off date (median 326 days)|Intention-to-treat analysis set included all randomized participants. Participants who were evaluable for this measure at given time period for the arm were included in the category.|||event/100 participant-years||95% Confidence Interval|Number
2587865|NCT02313909|Secondary|Incidence Rate of the Following: Stroke, Ischemic Stroke, Disabling Stroke, Cardiovascular (CV) Death, Myocardial Infarction|"Disabling stroke is defined as stroke with modified Rankin score (mRS) greater than or equal to (>=) 4 as assessed by investigator. mRS spans 0-6, running from perfect health to death. A score of 0-3 indicates functional status ranging from no symptoms to moderate disability (defined in the mRS as requiring some help, but able to walk without assistance); mRS 4-6 indicates functional status ranging from moderately severe disability (unable to walk or to attend to own bodily needs without assistance)through to death. CV death includes death due to hemorrhage and death with undetermined/unknown cause. Diagnosis of myocardial infarction requires combination of: 1) evidence of myocardial necrosis either changes in cardiac biomarkers or post-mortem pathological findings); 2) supporting information derived from clinical presentation, electrocardiographic changes, or results of myocardial or coronary artery imaging."|From randomization until the efficacy cut-off date (median 326 days)|Intention-to-treat analysis set included all randomized participants. Participants who were evaluable for this measure at given time period for the arm were included in the category.|||event/100 participant-years||95% Confidence Interval|Number
2587866|NCT02313909|Secondary|Incidence Rate of All-Cause Mortality|All-cause mortality includes all deaths of participants due to any cause.|From randomization until the efficacy cut-off date (median 326 days)|Intention-to-treat analysis set included all randomized participants. Participants who were evaluable for this measure at given time period for the arm were included in the category.|||event/100 participant-years||95% Confidence Interval|Number
2587867|NCT02313909|Secondary|Incidence Rate of Any of the Following: Cardiovascular Death, Recurrent Stroke, Systemic Embolism and Myocardial Infarction|Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. Cardiovascular death includes death due to hemorrhage and death with undetermined/unknown cause. Systemic embolism is defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms. The diagnosis of myocardial infarction requires the combination of: 1)evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and 2)supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging.|From randomization until the efficacy cut-off date (median 326 days)|Intention-to-treat analysis set included all randomized participants. Participants who were evaluable for this measure at given time period for the arm were included in the category.|||event/100 participant-years||95% Confidence Interval|Number
2587868|NCT02313909|Primary|Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated)|Major bleeding event (as per ISTH), defined as bleeding event that met at least one of following: fatal bleeding; symptomatic bleeding in a critical area or organ (intraarticular, intramuscular with compartment syndrome, intraocular, intraspinal, pericardial, or retroperitoneal); symptomatic intracranial haemorrhage; clinically overt bleeding associated with a recent decrease in the hemoglobin level of greater than or equal to (>=) 2 grams per decilitre (g/dL) (20 grams per liter [g/L]; 1.24 millimoles per liter [mmol/L]) compared to the most recent hemoglobin value available before the event; clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood. The results were based on classification of events that have been positively adjudicated as major bleeding events. Incidence rate estimated as number of subjects with incident events divided by cumulative at-risk time, where subject is no longer at risk once an incident event occurred.|From randomization until the efficacy cut-off date (median 326 days)|Intention-to-treat analysis set included all randomized participants. Participants who were evaluable for this measure at given time period for the arm were included in the category.|||event/100 participant-years||95% Confidence Interval|Number
2587921|NCT02312882|Primary|Percent Change in Severity of Alopecia Tool (SALT) Score|SALT score range is from 0 (no hair loss) to 100 (100% hair loss). Positive percent change from baseline corresponds to reduction in SALT score.|0 and 3 months||||Percent change||Full Range|Median
2587869|NCT02313909|Primary|Incidence Rate of the Composite Efficacy Outcome (Adjudicated)|Components of composite efficacy outcome (adjudicated) includes stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging) and systemic embolism. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.|From randomization until the efficacy cut-off date (median 326 days)|Intention-to-treat analysis set included all randomized participants. Participants who were evaluable for this measure at given time period for the arm were included in the category.|||event/100 participant-years||95% Confidence Interval|Number
2587870|NCT02313766|Secondary|Discomfort of the Preoxygenation Phase Self Reported by the Patient|discomfort of the preoxygenation phase evaluated on a visual analogue scale (0 no discomfort - 100 maximal discomfort) just before PACU leaving|Before PACU leaving||||millimeters||Inter-Quartile Range|Median
2587871|NCT02313766|Secondary|Time Until SpO2=93%|time until SpO2=93% after endotracheal tube placement has been confirmed|up to 10 min||||seconds||Inter-Quartile Range|Median
2587872|NCT02313766|Primary|Time for Preoxygenationfrom Face Mask Positioning to FEO2=90%|Time measured form face mask positioning until FEO2 reached 90% on the gas monitor|up to 5 min||||seconds||Inter-Quartile Range|Median
2587873|NCT02313675|Secondary|Opioid Consumption (Number of Pills Taken)|"Daily opioid consumption assessed as number of pills taken that day, each day for 7 days post-operatively~Outcome measure reported below is mean number of opioid pills consumed per day."|7 days||||pills consumed||Full Range|Mean
2587874|NCT02313675|Primary|Postoperative Pain (Pain Scores From 0-10 Scale)|This is an ordinal pain scale. The patient picks a number from 0-10 scale every 4 hours for 7 days post-operatively. 0 is no pain, 10 is the worst pain imaginable. Lower scores would be preferable to higher scores.|7 days||||units on a scale||95% Confidence Interval|Mean
2587875|NCT02313558|Primary|Gingivitis Assessment After 12 Weeks of Dentifrice Use|"After 12 weeks gingivitis was scored according to the Löe-Silness Gingival Index. Each tooth was scored on facial and lingual surfaces. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. The gingiva adjacent to each tooth surface was scored as follows: 0 = Absence of inflammation; 1 = Mild inflammation: slight change in color and little change in texture; 2 = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing; 3 = Severe inflammation: marked redness and hypertrophy. Tendency for spontaneous bleeding.~Whole-mouth mean scores were obtained by averaging the values obtained over all scoreable surfaces in the mouth."|12 weeks after dentifrice use||||units on a scale||Standard Deviation|Mean
2587876|NCT02313558|Primary|Plaque Assessment After 12 Weeks of Dentifrice Use|"After 12 weeks supra-gingival plaque on the facial and lingual surfaces of each tooth was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. Plaque was disclosed and scored on each tooth surface according to the following criteria: 0 = No plaque; 1 = Separate flecks of plaque at the cervical margin of the tooth; 2 = A thin, continuous band of plaque (up to 1 mm) at the cervical margin of the tooth; 3 = A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth; 4 = Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth; 5 = Plaque covering 2/3 or more of the side of the crown of the tooth.~Whole-mouth mean scores were obtained by averaging the values obtained over all scoreable surfaces in the mouth."|12 weeks after dentifrice use||||units on a scale||Standard Deviation|Mean
2587877|NCT02313558|Primary|Gingivitis Assessment After 6 Weeks of Dentifrice Use|After 6 weeks gingivitis was scored according to the Löe-Silness Gingival Index. Each tooth was scored on facial and lingual surfaces. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. The gingiva adjacent to each tooth surface was scored as follows: 0 = Absence of inflammation; 1 = Mild inflammation: slight change in color and little change in texture; 2 = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing; 3 = Severe inflammation: marked redness and hypertrophy. Tendency for spontaneous bleeding.|6 weeks after dentifrice use||||units on a scale||Standard Deviation|Mean
2587878|NCT02313558|Primary|Plaque Assessment After 6 Weeks of Dentifrice Use|"After 6 weeks supra-gingival plaque on the facial and lingual surfaces of each tooth was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. Plaque was disclosed and scored on each tooth surface according to the following criteria: 0 = No plaque; 1 = Separate flecks of plaque at the cervical margin of the tooth; 2 = A thin, continuous band of plaque (up to 1 mm) at the cervical margin of the tooth; 3 = A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth; 4 = Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth; 5 = Plaque covering 2/3 or more of the side of the crown of the tooth.~Whole-mouth mean scores were obtained by averaging the values obtained over all scoreable surfaces in the mouth."|6 weeks after dentifrice use||||units on a scale||Standard Deviation|Mean
2587879|NCT02313506|Secondary|Partners in Health Scale|The Partners in Health Scale is a 12-item measure designed to assess disease self-management abilities including knowledge of health conditions, ability to participate in decision-making with health care professionals, and ability to pursue a healthy lifestyle. Scores range from 0 to 96, with lower being better.|Baseline; 1 month and 2 months from baseline|The number of participants analyzed is the same as the number of participants assigned to each group.|||score on a scale||Standard Deviation|Mean
2587880|NCT02313506|Secondary|KOOS - Knee-related Quality of Life|Quality of life was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.|Baseline; 1 month and 2 months from baseline|The number of participants analyzed is the same as the number of participants assigned to each group.|||score on a scale||Standard Deviation|Mean
2587881|NCT02313506|Secondary|KOOS - Sport and Recreation Function|Sport and Recreation Function was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.|Baseline; 1 month and 2 months from baseline|The number of participants analyzed is the same as the number of participants assigned to each group.|||score on a scale||Standard Deviation|Mean
2587882|NCT02313506|Secondary|KOOS - Activities of Daily Living|Activities of Daily Living was measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.|Baseline; 1 month and 2 months from baseline|The number of participants analyzed is the same as the number of participants assigned to each group.|||score on a scale||Standard Deviation|Mean
2587883|NCT02313506|Secondary|KOOS - Pain|Pain was measured by a Knee Injury and Osteoarthritis Outcome Score subscale. Scores range from 0 to 100, with higher being better.|Baseline; 1 month and 2 months from baseline|The number of participants analyzed is the same as the number of participants assigned to each group.|||score on a scale||Standard Deviation|Mean
2587884|NCT02313506|Secondary|KOOS - Symptoms|Symptoms were measured by Knee Injury and OA Outcome Score (KOOS). The KOOS measures knee osteoarthritis disease status and consists of five sub-scales: knee pain, stiffness, daily activity, sports/recreation, and quality of life. Scores range from 0 to 100, with higher being better.|Baseline; 1 month and 2 months from baseline|The number of participants analyzed is the same as the number of participants assigned to each group.|||score on a scale||Standard Deviation|Mean
2587885|NCT02313506|Secondary|Time Spent in Sedentary Behavior|We calculated the average daily time spent with an energy expenditure of 1.5 METs or lower, occurring in bouts of > 20 minutes during waking hours.|Baseline; 1 month and 2 months from baseline|The number of participants analyzed is the same as the number of participants assigned to each group.|||Minutes per day||Standard Deviation|Mean
2587886|NCT02313506|Primary|Time Spent in Moderate-to-Vigorous Physical Activity (MVPA)|Participants wore a SenseWear Mini device for 7 days at baseline, and Months 1 and 2. We calculated the average time spent in MVPA accumulated in bouts per day. A bout is defined as 10 consecutive minutes or more at the level of 3 or higher METs, with allowance for interruption of up to 1 minute below the threshold.|Baseline; 1 month and 2 months from baseline|The number of participants analyzed is the same as the number of participants assigned to each group.|||Minutes per day||Standard Deviation|Mean
2587887|NCT02313454|Secondary|Change From Pre-Application to Post-Application in Dry Eye Symptoms (DES) Using a Visual Analog Scale (VAS)|"The participant rated their eye dryness (both eyes simultaneously) at all visits and every 5 minutes during CAE exposure by placing a vertical mark on the 100 mm horizontal line to indicate the level of eye dryness. 0 corresponds to no dryness and 100 corresponds to maximal dryness. A negative change from Baseline indicates improvement."|Pre-application to Post-application on Day 0|PP Population was defined as all participants that were able to return to the threshold level following both treatments and did not have any significant protocol violations that might be expected to alter the outcome of their study results|||score on a scale||Standard Deviation|Mean
2587888|NCT02313454|Primary|Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score|The participant graded their eye discomfort prior to CAE entry, during CAE exposure to threshold, then starting 1 minute after treatment application every 5 minutes in each eye separately using the Ora Calibra ODS where: 0=no discomfort to 4=constant discomfort. Data from the analysis eye was used to determine effectiveness. The analysis eye was defined as the first eye that reached the threshold and resulted in the device application. If both eyes reached the threshold at the same time point, the analysis eye was the eye with the lowest baseline Schirmer test score (a test to determine if the eye produces enough tears to keep it moist; >10 mm is normal) or, if the Schirmer test scores were equal, the right eye. A negative change from Baseline indicates improvement.|Pre-application to Post-application on Day 0|Per-Protocol (PP) Population was defined as all participants that were able to return to the threshold level following both treatments and did not have any significant protocol violations that might be expected to alter the outcome of their study results.|||score on a scale||Standard Deviation|Mean
2587889|NCT02313233|Primary|Quality of Life (QoL) Index Between V1 and V6 for the Subjects Taking 0.4 mg Harnalidge|The Quality of Life (QoL) is a single question with scores of 0~6 point and corresponding to the assessment index ranging from delighted to terrible.|56 days|All these twenty-two subjects included in this statistical result have been received 0.4 mg Harnalidge for BPH treatment.|||units on a scale||Standard Deviation|Mean
2587890|NCT02313233|Primary|International Prostate Symptom Score (IPSS) Between V1 and V6 in the Same Medication for More Than 12 Months|It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points.|56 days|All these five subjects in this statistical result have been treated BPH with 0.4 mg of Harnalidge for more than 12 months.|||units on a scale||Standard Deviation|Mean
2587891|NCT02313233|Primary|Quality- Of- Life Index (QoL)|The QoL index is a single question with scores of 0~6 point and corresponding to the assessment index ranging from delighted to terrible.|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), 5 subjects receiving Hatnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben XL 4 mg QD for BPH treatment|||units on a scale||Standard Deviation|Mean
2587892|NCT02313233|Secondary|Prostate-specific Antigen (PSA) Level|Serum PSA test measures the amount of prostate- specific antigen in the blood. As a man's prostate enlarges with age, the amount of PSA in the blood normally increases.|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.|||ng/ml||Standard Deviation|Mean
2587893|NCT02313233|Secondary|Prostate Volume|It's related to progression of benign prostatic hyperplasia (BPH).|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.|||cm^3||Standard Deviation|Mean
2587894|NCT02313233|Secondary|Postvoid Residual Volume (PVR)|The PVR urine test measures the amount of urine left in the bladder after urination.|56 days|For all subjects' medical histories in this study, there are one subject receiving Harnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receivingHarnalidge 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.|||ml||Standard Deviation|Mean
2587896|NCT02313233|Primary|International Prostate Symptom Score (IPSS)|It's 7- item urinary symptom severity scale. The answers are assigned points from 0 to 5, indicating increasing severity. The total score can therefore range from 0 to 35 points.|56 days|For all subjects' medical histories in this study, there are one subject receiving Hatnalidge 0.1 mg once daily (QD), five subjects receiving Harnalidge 0.2 mg QD, 22 subjects receiving Harnalidge 0.4 mg QD and eight subjects receiving Doxaben 4 mg or Doxaben XL 4 mg QD for BPH treatment.|||units on a scale||Standard Deviation|Mean
2587897|NCT02313155|Secondary|GMT in SRH Antibody Titer (Cell Derived Antigen)|GMT in SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||titer||95% Confidence Interval|Geometric Mean
2587898|NCT02313155|Secondary|GMFI in SRH Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination|GMFI in SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) as compared to pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.|Pre-vaccination, 21 Days After vaccination (Day 22)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||fold increase||95% Confidence Interval|Geometric Mean
2587899|NCT02313155|Secondary|Percentage of Participants With Seroconversion in SRH Antibody Titer (Cell Derived Antigen)|Seroconversion rate as measured by the SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) was defined as percentage of participants achieving a minimal 50% increase from the baseline SRH antibody titer (baseline >4 mm^2) or achieving an SRH antibody titer of >=25 mm^2 (baseline <=4 mm^2) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||percentage of participants||95% Confidence Interval|Number
2587900|NCT02313155|Secondary|Percentage of Participants With Seroprotection in SRH Antibody Titer (Cell Derived Antigen) of >=25 mm^2|Seroprotection rate as measured by SRH antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) was defined as percentage of participants with a SRH antibody titer of >=25 mm^2 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||percentage of participants||95% Confidence Interval|Number
2587901|NCT02313155|Secondary|GMT in HI Antibody Titer (Cell Derived Antigen)|GMT in HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||titer||95% Confidence Interval|Geometric Mean
2587902|NCT02313155|Secondary|GMFI in HI Antibody Titer (Cell Derived Antigen) From Pre-vaccination to 21 Days After Vaccination|GMFI in HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) as compared to pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.|Pre-vaccination, 21 Days After vaccination (Day 22)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||fold increase||95% Confidence Interval|Geometric Mean
2587903|NCT02313155|Secondary|Percentage of Participants With Seroconversion in HI Antibody Titer (Cell Derived Antigen)|Seroconversion rate as measured by the HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) was defined as percentage of participants achieving a minimal 4-fold increase from the baseline HI antibody titer (baseline >=10) or achieving an HI antibody titer of >=40 (baseline HI <10) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||percentage of participants||95% Confidence Interval|Number
2587904|NCT02313155|Secondary|Percentage of Participants With Seroprotection in HI Antibody Titer (Cell Derived Antigen) of >=40|Seroprotection rate as measured by HI antibody titer (vero antigen, live-vero antigen, and madin-darby canine kidney [MDCK] antigen) was defined as percentage of participants with an HI antibody titer of >=40 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||percentage of participants||95% Confidence Interval|Number
2587905|NCT02313155|Secondary|GMT in SRH Antibody Titer (Egg-derived Antigen)|GMT in SRH antibody titer (egg-derived antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||titer||95% Confidence Interval|Geometric Mean
2587906|NCT02313155|Secondary|GMFI in SRH Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination|GMFI in SRH antibody titer (egg-derived antigen) as compared to baseline pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.|Pre-vaccination, 21 Days after vaccination (Day 22)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||fold increase||95% Confidence Interval|Geometric Mean
2587907|NCT02313155|Secondary|Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)|Seroconversion rate as measured by the SRH antibody titer (egg-derived antigen) was defined as percentage of participants achieving a minimal 50% increase from the baseline SRH antibody titer (baseline >4 mm^2) or achieving an SRH antibody titer of >=25 mm^2 (baseline <=4 mm^2) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||percentage of participants||95% Confidence Interval|Number
2602011|NCT02147301|Primary|Number of Patients Who Developed New Severe Adverse Events|Number of patients who developed new severe adverse events according to NCI CTCAE version 4.0|1 year||||participants|||Number
2587908|NCT02313155|Secondary|Percentage of Participants With Seroprotection in SRH Antibody Titer (Egg-derived Antigen) of >=25 mm^2|Seroprotection rate as measured by SRH antibody titer (egg-derived antigen) was defined as percentage of participants with an SRH antibody titer of >=25 mm^2 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||percentage of participants||95% Confidence Interval|Number
2587909|NCT02313155|Secondary|Geometric Mean Titer (GMT) in HI Antibody Titer (Egg-derived Antigen)|GMT in HI antibody titer (egg-derived antigen) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain) was computed along with 95% CI.|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||titer||95% Confidence Interval|Geometric Mean
2587910|NCT02313155|Secondary|Change From Baseline in Body Temperature|Change from baseline in body temperature (oral) was reported.|Baseline, Day 22|Safety analysis set was defined as all participants who received vaccination with the study drug.|||degree celsius||Standard Deviation|Mean
2587911|NCT02313155|Secondary|Change From Baseline in Pulse|Change from baseline in pulse was reported.|Baseline, Day 22|Safety analysis set was defined as all participants who received vaccination with the study drug.|||beats per minute||Standard Deviation|Mean
2587912|NCT02313155|Secondary|Change From Baseline in Blood Pressure|Change from baseline in systolic and diastolic blood pressure was reported|Baseline, Day 22|Safety analysis set was defined as all participants who received vaccination with the study drug.|||millimeter mercury (mmHg)||Standard Deviation|Mean
2587913|NCT02313155|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values|Laboratory values included hematology, biochemistry and urinalysis tests.|Baseline,up to 21 Days after drug administration (Day 22)|Safety analysis set was defined as all participants who received vaccination with the study drug.|||participants|||Number
2587914|NCT02313155|Primary|Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-derived Antigen) From Pre-vaccination to 21 Days After Vaccination|GMFI in HI antibody titer (egg-derived antigen) as compared to pre-vaccination was evaluated for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain). Geometric mean and CI were calculated for GMFIs.|Pre-vaccination, 21 Days After vaccination (Day 22)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||fold increase||95% Confidence Interval|Geometric Mean
2587915|NCT02313155|Primary|Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)|Seroconversion rate as measured by the HI antibody titer (egg-derived antigen) was defined as percentage of participants achieving a minimal 4-fold increase from the baseline HI antibody titer (baseline >=10) or achieving an HI antibody titer of >=40 (baseline <10) for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||percentage of participants||95% Confidence Interval|Number
2587916|NCT02313155|Primary|Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-derived Antigen) of >=40.|Seroprotection rate as measured by HI antibody titer (egg-derived antigen) was defined as percentage of participants with the HI antibody titer of >=40 for each of the three influenza virus strains (A/H1N1 strain, A/H3N2 strain, and B strain).|Day 22 (21 days after vaccination)|Full analysis set was defined as participants who were randomized and received vaccination with the study drug.|||percentage of participants||95% Confidence Interval|Number
2587917|NCT02313155|Primary|Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Up to 21 days (Day 22) after vaccination|Safety analysis set was defined as all participants who received vaccination with the study drug.|||participants|||Number
2587918|NCT02313155|Primary|Number of Participants Reporting Solicited Local and Systemic Adverse Events (AEs)|Number of participants with local reactions (injection site pain, injection site redness, injection site swelling, injection site induration, injection site tenderness, and injection site ecchymosis) and systemic events (pyrexia, malaise, chills, fatigue, headache, sweaty, myalgia, arthralgia, nausea and vomiting) were reported using an electronic diary.|Up to 21 days (Day 22) after vaccination|Safety analysis set was defined as all participants who received vaccination with the study drug.|||participants|||Number
2587919|NCT02312934|Secondary|Conners Continuous Performance Test|"The secondary outcome measure was the computerized Conners Continuous Performance Test (CPT), which measures sustained attention and vigilance. Participants see a series of letters appearing one at a time on a computer screen and they press a button for every letter that appears on the screen, except for X. Lower scores indicate better performance.~Scores on the CPT are calculated using the each participant's performance on the task (defined as reaction time (in ms) standard error/interstimulus interval). Change scores from baseline are then calculated. A decrease in CPT score = improvement.~*This is not a clinical measure. This is a research measure of reaction time variability and therefore there is no clinical interpretation and no defined score range.*"|Baseline to 8 Weeks||||ms||Standard Deviation|Mean
2587920|NCT02312934|Primary|Change in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) PCI Scale|"The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale will be used to monitor change in CRCI subjective complaints.~This instrument has been used to monitor change in CRCI subjective complaints in previous studies and demonstrates good internal consistency, test-retest reliability, and discriminant and convergent validity. Specifically, the PCI subscale was used as the primary outcome measure.~The FACT-Cog PCI consists of 20 items and has a minimum score of 0 and total possible score of 72. Higher scores indicate better cognitive functioning.~The PCI evaluates memory, concentration, mental acuity, verbal fluency, functional interference, and multitasking ability.~Visit 3 is the 3-week visit, Visit 4 is the 6-week visit, and Visit 5 is the 8-week visit.~Change scores were calculated as follow"|Baseline to 8-Weeks||||units on a scale||Standard Deviation|Mean
2587922|NCT02312856|Primary|Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death|"Raymond Scale- an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms. Achieving a Raymond Score I/II.~class I: complete obliteration class II: residual neck class III: residual aneurysm class IIIa: contrast opacification within the coil interstices of a residual aneurysm class IIIb: contrast opacification outside the coil interstices, along the residual aneurysm wall. Raymond I is typically associated with better outcomes. The primary outcome of the study looked at safety (death or stroke) and Rate of Aneurysm occlusion (assess by Raymond Roy scores) the two are different. The RR Score is an assessment of occlusion and not used to assess death."|180 days post procedure|One enrolled participant had MRA performed instead of an angiogram and is excluded from Raymond Score analysis.|||Participants|||Number
2587923|NCT02312739|Secondary|Provider Ease of Insertion (0-100mm VAS)|Physician who did the procedure will complete a 0-100mm VAS on ease of insertion of the sterilization devices with anchors 0 equals no difficulty and 100 equals very difficult.|Within 5 minutes after the Essure® procedure||||units on a scale||Standard Deviation|Mean
2587924|NCT02312739|Secondary|Patient Satisfaction (5-point Likert Scale)|Patients were asked to rate their overall satisfaction with the procedure using a 5-point Likert scale (Very unsatisfied, Unsatisfied, Neutral, Satisfied, Very satisfied). Results were analyzed to portray the percentage of participants who felt satisfied at the listed interval levels.|Prior to discharge from clinic, approximately 30-45 minutes post-procedure||||percentage of participants|||Number
2587925|NCT02312739|Secondary|Change From Baseline in Patient Anxiety Scale After the Procedure|Participants were asked to complete a validated short form of the Spielberger State-Trait Anxiety Inventory (STAI) at baseline and at 3-5 minutes after the in-office sterilization procedure. On the STAI scale, participants rated five statements (I feel calm, I am tense, I feel upset, I am relaxed, I am worried) on a 1 - 4 scale (Not at all, Somewhat, Moderately, Very Much, totaling in a score from 0-20 (0 being least anxious, 20 being the most anxious).|At baseline before the procedure and at 3-5 minutes after the Essure® procedure||||units on a scale||Standard Deviation|Mean
2587926|NCT02312739|Primary|Pain Scale Measurement - Maximum Pain Experienced|The maximum pain that was experienced during the procedure is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. It is taken at 3 to 5 minutes following completion of the procedure.|At 3-5 minutes after the procedure||||units on a scale||Standard Deviation|Mean
2587927|NCT02312739|Primary|Change From Baseline in Pain Scale Measurement During and After the Procedure|Pain is assessed using a 0-100mm VAS with anchors 0 equals no pain and 100 equals worst pain imaginable. It is taken at baseline, after paracervical block injection and after placement of second Essure® coil. A final pain assessment is done prior to discharge.|At baseline before the procedure, during the procedure after paracervical block injection and after placement of second Essure® coil, and prior to discharge from clinic (approximately 30-45 minutes postprocedure)||||units on a scale||Standard Deviation|Mean
2587928|NCT02312726|Other Pre-specified|Provider Ease-of-insertion|The provider who inserts the IUD will be asked to complete a 4-item Likert scale rating perceived difficultly of insertion: 1 = easy; 2 = somewhat easy; 3 = somewhat difficult, 4 = difficult.|Within 5 minutes following postpartum IUD insertion||||participants|||Number
2587929|NCT02312726|Secondary|Pain Score: Verbal Rating Scale (VRS)|This is a 4-item ordinal pain scale which has been used for pain level assessment. When prompted, patients will be asked to indicate which level of pain most accurately represents their pain level; 0 = No pain, 1 = Mild pain, 2 = Moderate pain, 3 = Severe pain.|Immediately prior to and within 5 minutes after IUD insertion following vaginal delivery. Women who undergo a postpartum interview will be asked to perform a recal VRS pain assessment||||participants|||Number
2587930|NCT02312726|Secondary|Pain Score: Visual Analog Scale (VAS)|This is a validated instrument used extensively in the assessment of acute pain. When prompted, patients will be asked to mark the continuous 100 mm VAS line at the point which most accurately represents their pain level; 0 = no pain, 100 = pain as bad as it could be.|Immediately prior to and within 5 minutes after IUD insertion following vaginal delivery; women who undergo a postpartum interview will be asked to perform a recall VAS pain assessment||||units on a scale||Standard Deviation|Mean
2587931|NCT02312726|Primary|Assessment of Women's Experiences With Ring Forceps Postplacental IUD Placement Through Semi-structured Interviews|A semi-structured interview guide(available in both English and Spanish) which was developed in consultation with an expert in qualitative methodology at the UNM Clinical & Translational Science Center (CTSC), and UNMH family planning experts, will be administered to all participants. The interview will incorporate the following domains of women's perceptions of the postplacental IUD insertion experience: decisional influence, experience during the procedure, decisional regret, prior knowledge/ awareness of the method and postpartum contraception in general. The interview will conclude with an overall patient satisfaction score measured on a five-point Likert scale: 1 = very dissatisfied, 2 = somewhat dissatisfied, 3 = neutral, 4 = somewhat satisfied, 5 = very satisfied.|Within 24-48 hours after vaginal delivery, prior to hospital discharge|21 participants (out of the 68 included in the study) consented to an interview regarding their experience. We conducted 21 interviews; 9 with women who did not have an epidural and 12 with women who had an epidural.|||participants|||Number
2587932|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in Additional Self-Report Physical Activity Items|Number of minutes per week, on average, they are completing strengthening, stretching, and aerobic exercises. The minimum score is 0, and there is no maximum score; higher scores indicate more weekly activity.|baseline, 4 months, and 12 months||||minutes per week||95% Confidence Interval|Least Squares Mean
2587933|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Physical Activity Scale for the Elderly (PASE)|"The Physical Activity Scale for the Elderly (PASE) is a self-report, 12-item scale that measures level occupational, household, and leisure activity during a one-week period. This scale was particularly developed for use among older adults; although all participants in the proposed study will not be age 65 or over, patients with knee OA typically have more limited physical activity than the general population. Therefore we believe this scale will be more applicable to our participant group than scales that were developed for younger adults.~The typical range for the total PASE score is 0-400, with higher scores indicating greater activity."|baseline, 4 months, and 12 months||||units on a scale||95% Confidence Interval|Least Squares Mean
2587934|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in the The Brief Fear of Movement Scale|"The Brief Fear of Movement Scale is a six item scale for assessing fear of movement in OA. The scale specifically assesses activity avoidance due to pain-related fear of movement. All items are measured on a 4-point scale from strongly agree to strongly disagree. The score ranges from 0-24 with higher scores indicating more fear of movement."|baseline, 4 months, and 12 months||||units on a scale||95% Confidence Interval|Least Squares Mean
2587935|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Fatigue Instrument|The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. It assesses fatigue over the past seven days, This scale includes 8 items, each measured on a 5-point Likert scale. Per PROMIS scoring instructions, raw scores are converted into standardized t-scores with a mean of 50 and standard deviation of 10. T-scores can range from 33.1-77.8; higher scores indicate worse fatigue.|baseline, 4 months, and 12 months||||units on a scale||95% Confidence Interval|Least Squares Mean
2587936|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in The PROMIS Sleep-related Impairment Instrument|The PROMIS adult sleep related impairment item bank focuses on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. It assesses sleep-related impairment over the past seven days. This scale includes 8 items, each measured on a 5-point Likert scale. Per PROMIS scoring instructions, raw scores are converted into standardized t-scores with a mean of 50 and standard deviation of 10. T-scores can range from 30.5-77.6; higher scores indicate worse sleep impairment.|baseline, 4 months, and 12 months||||units on a scale||95% Confidence Interval|Least Squares Mean
2587937|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to Month 12 in The Knee Injury and Osteoarthritis Outcome Score (KOOS)|The KOOS is a patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. Five KOOS subscale scores were administered: Pain (9 items), Function in daily living (17 items), Function in Sport and Recreation (5 items), and knee-related Quality of Life (4 items). All items are scored on 5-point Likert scales. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale|baseline, 4 months, and 12 months||||units on a scale||95% Confidence Interval|Least Squares Mean
2587938|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Patient Health Questionnaire-8|Depressive symptoms and severity will be assessed using the PHQ-8, a reliable and valid measure of depression71. The PHQ-8 is an eight-item survey derived from the Primary Care Evaluation of Mental Disorders (PRIME-MD) diagnostic tool, and consists of items corresponding to the depression criteria listed in the Diagnostic and Statistics Manual Fourth Edition (DSM-IV). Each of the eight questions is scored as 0 (not at all) to 3 (nearly every day), so that total scores range from 0 to 24, with higher scores indicating more depressive symptoms.|baseline, 4 months, and 12 months||||units on a scale||95% Confidence Interval|Least Squares Mean
2587939|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Timed Up and Go|One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the timed up and go, there are no minimum or maximum scores (participants complete the task as quickly as they are able); shorter (lower) times indicate better function.|baseline, 4 months, and 12 months||||seconds||95% Confidence Interval|Least Squares Mean
2587940|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 30 Second Chair Stand|One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the 30 second chair stand test, the minimum is 0 stands and there is no maximum scale score (participants complete as many stands as they can in 30 seconds; greater numbers of stands indicate better function.|baseline, 4 months, and 12 months||||number of stands from a chair in 30 sec||95% Confidence Interval|Least Squares Mean
2587941|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function- Unilateral Stand Time|One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the unilateral stand test, scores scan range from 0-10 seconds, with higher time indicating better balance.|baseline, 4 months, and 12 months||||seconds||95% Confidence Interval|Least Squares Mean
2587942|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in Objective Physical Function - 2 Minute Step Test|One of 4 tests that objectively assessed physical function. These 4 tests included: unilateral stand time; time to rise from a chair and return to the seated position for 30 seconds; timed up and go- rise from a seated position, walk a short distance and return to seated position; and a 2 minute step test. For this outcome measure, the 2 minute step test, the minimum is 0 steps and there is no maximum scale score (participants complete as many steps as they can in 2 minutes); greater steps indicate better function.|baseline, 4 months, and 12 months||||number of steps taken in 2 minutes||95% Confidence Interval|Least Squares Mean
2587943|NCT02312713|Secondary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in the Satisfaction With Physical Function Scale|This is a validated, 5-item questionnaire that assesses patients' satisfaction with their ability to complete basic functional tasks that are often affected by lower extremity OA, including stair-climbing, walking, doing housework (light and heavy, and lifting and carrying). All 5 items are rated on a 7 point scale ranging from Very Dissatisfied (-3) Very Satisfied (+3). The total scale ranges from -15 to +15,with higher scores indicating greater satisfaction with function.|baseline, 4 months, and 12 months||||units on a scale||95% Confidence Interval|Least Squares Mean
2587944|NCT02312713|Primary|Change From Baseline to Month 4 and Change From Baseline to 12 Month in Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index Score|Change over time in the primary outcome measure for this study, the WOMAC is a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items). The scale ranges from 0-96 with higher scores indicating worse symptoms and function.|baseline, 4 months, and 12 months||||units on a scale||95% Confidence Interval|Least Squares Mean
2587945|NCT02312687|Primary|Change From Baseline Over Time in P1NP||Baseline, Weeks 24, 48, 72, 96, 120, 144|PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.|||ng/mL||Standard Error|Least Squares Mean
2587946|NCT02312687|Primary|Change From Baseline Over Time in CTx||Baseline, Weeks 24, 48, 72, 96, 120, 144|PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.|||pg/mL||Standard Error|Least Squares Mean
2587947|NCT02312687|Primary|Change From Baseline Over Time in BALP||Baseline, Weeks 24, 48, 72, 96, 120, 144|PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.|||mcg/L||Standard Error|Least Squares Mean
2587948|NCT02312687|Primary|Change From Baseline Over Time in Total ALP||Baseline, Weeks 24, 48, 72, 96, 120, 144|PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.|||U/L||Standard Error|Least Squares Mean
2587949|NCT02312687|Primary|Change From Baseline Over Time in 24-Hour Urine Calcium/Creatinine Ratio||Baseline, Weeks 24, 48, 72, 96, 120, 144|PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.|||mg/mg||Standard Error|Least Squares Mean
2587950|NCT02312687|Primary|Change From Baseline Over Time in 24-Hour Urine Creatinine||Baseline, Weeks 24, 48, 72, 96, 120, 144|PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.|||mg/24hr||Standard Error|Least Squares Mean
2587951|NCT02312687|Primary|Change From Baseline Over Time in 24-Hour Urine Calcium||Baseline, Weeks 24, 48, 72, 96, 120, 144|PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.|||mg/24hr||Standard Error|Least Squares Mean
2587952|NCT02312687|Primary|Change From Baseline Over Time in 24-hour Urine Phosphorus||Baseline, Weeks 24, 48, 72, 96, 120, 144|PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.|||g/24hr||Standard Error|Least Squares Mean
2587953|NCT02312687|Primary|Change From Baseline Over Time in FEP||Baseline, Weeks 24, 48, 72, 96, 120, 144|PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.|||fraction of phosphorus excreted||Standard Error|Least Squares Mean
2587954|NCT02312687|Primary|Change From Baseline Over Time in in 2-hour Urine TRP||Baseline, Weeks 24, 48, 72, 96, 120, 144|PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.|||fraction of phosphorus reabsorbed||Standard Error|Least Squares Mean
2587955|NCT02312687|Primary|Change From Baseline Ovr Time in 2-hour Urine TmP/GFR||Baseline, Weeks 24, 48, 72, 96, 120, 144|PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.|||mg/dL||Standard Error|Least Squares Mean
2587956|NCT02312687|Primary|Change From Baseline Over Time in Serum 1,25(OH)2D||Baseline, Weeks 24, 48, 72, 96, 120, 144|PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.|||pg/mL||Standard Error|Least Squares Mean
2587957|NCT02312687|Primary|Change From Baseline Over Time in Serum Free FGF23||Baseline, Weeks 24, 48, 72, 96, 120, 144|PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.|||pg/mL||Standard Error|Least Squares Mean
2587958|NCT02312687|Primary|Change From Baseline Over Time in Serum Total FGF23||Baseline, Weeks 24, 48, 72, 96, 120, 144|PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.|||pg/mL||Standard Error|Mean
2587959|NCT02312687|Primary|Change From Baseline Over Time in Serum iPTH||Baseline, Weeks 24, 48, 72, 96, 120, 144|PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.|||pg/mL||Standard Error|Least Squares Mean
2587960|NCT02312687|Primary|Change From Baseline Over Time in Serum Phosphorus||Baseline, Weeks 24, 48, 72, 96, 120, 144|PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.|||mg/dL||Standard Error|Least Squares Mean
2587961|NCT02312687|Primary|Percentage of Participants Reaching Serum Phosphorus Normal Range at Baseline and Any Time After Dosing||Through Week 184|Pharmacodynamic (PD) Analysis Set: all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data.|||percentage of participants||95% Confidence Interval|Number
2587962|NCT02312687|Primary|Number of Participants Positive for Anti-KRN23 Antibodies and Neutralizing Antibodies at Baseline and Anytime Post-Baseline||Through Week 184|Participants tested for neutralizing antibodies (n=4) are those who were positive for anti-KRN23 antibodies at any time during the study.|||Participants|||Count of Participants
2587963|NCT02312687|Primary|Number of Participants With Clinically Significant Changes From Baseline in Renal Ultrasound, by Category|Clinically significant changes from baseline reported as adverse events are presented.|Through Week 184||||Participants|||Count of Participants
2587964|NCT02312687|Primary|Number of Participants With Clinically Significant Changes From Baseline in ECGs|Clinically significant changes from baseline reported as adverse events are presented.|Through Week 184||||Participants|||Count of Participants
2587965|NCT02312687|Primary|Number of Participants With Clinically Significant Changes From Baseline in Echocardiogram (ECHO) Tests|Clinically significant changes from baseline reported as adverse events are presented.|Through Week 184||||Participants|||Count of Participants
2587969|NCT02312687|Primary|Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death|An AE is defined as any untoward medical occurrence, whether or not considered drug related. An SAE or serious suspected adverse reaction is an AE or suspected adverse reaction that at any dose, in the view of either the investigator or sponsor, results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect; an important medical event. A TEAE is an AE that occurred on or after the first burosumab dose. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). AEs were classified by the Investigator as possibly related, probably related, or definitely related.|Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).|Safety Analysis Set|||Participants|||Count of Participants
2587970|NCT02312622|Secondary|Related Adverse Events (Toxicity)|Toxicity, defined as related adverse events, is reported as the total number of events experienced by the participants in each cohort, a number without dispersion. Related is defined as meaning possibly, probably, or definitely related to the study drug.|Up to 2 years|All participants are included.|||adverse events|||Number
2587971|NCT02312622|Secondary|Systemic Disease Control (Cohort B)|"Systemic (ie, non-central nervous system) disease control (DC) rate by cohort is defined as the number of patients with complete response (CR) + partial response (PR) + stable disease (SD), divided by the total number of patients. The outcome will be reported as DC rate, a number without dispersion.~Response criteria are as follows. Note that any lesion < 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.~CR = Disappearance of all lesions, no new lesions; pathological lymph nodes reduced in short axis to < 10 mm~PR = ≥ 30% decrease in sum of lesion diameters; no new lesions; no progression of non-target lesions~PD = Any of 20% increase in sum of lesion diameters; progression of non-target lesions; new lesions~SD = Neither CR, PR, nor PD"|At 12 weeks|This outcome was restricted by protocol to Cohort B.|||Participants|||Count of Participants
2587972|NCT02312622|Secondary|Central Nervous System (CNS) Disease Control (Cohort B)|"Central nervous system (CNS) disease control (DC) is defined as a complete response (CR); partial response (PR); or stable disease (SD). The outcome is reported as the number and percentage of participants who achieve DC, a number without dispersion.~Response criteria are as follows. Note that any lesion less than 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.~CR = Disappearance of all target lesions, sustained for ≥ 4 weeks with no new lesions; clinical condition stable or improved~PR = ≥ 30% decrease in target lesion LD and no new lesions, sustained for ≥ 4 weeks; clinical condition stable or improved~PD = Any of 20% increase in target lesion LD; increase in T2/FLAIR non-enhancing lesions; any new lesions; non-target progression; or clinical deterioration~SD = Neither PR or PD"|At 12 weeks|This outcome was restricted by protocol to Cohort B.|||Participants|||Count of Participants
2587973|NCT02312622|Secondary|Overall Survival (Cohort A and C)|Overall survival (OS) is defined as the period remaining alive after the start of treatment. The outcome is reported as the median with full range.|4 years|Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome.|||months||Full Range|Median
2587974|NCT02312622|Secondary|Progression-free Survival (PFS) (Cohort A and C)|Progression-free survival (PFS) is defined as the time from the date of start of treatment until disease progression or death. The outcome is reported by cohort as PFS in months, with full range.|Date of first dose of pegylated irinotecan NKTR 102 to date of disease progression, assessed up to 2 years|Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome.|||months||Full Range|Median
2587975|NCT02312622|Secondary|Systemic (Non-CNS) Response Rate (Cohort A and C)|"Systemic (ie, non-central nervous system) response rate by cohort is defined as the number of participants achieving a complete response (CR) or partial response (PR), divided by the number of participants. The outcome will be reported as a number without dispersion.~Response criteria are as follows. Note that any lesion < 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.~CR = Disappearance of all target lesions, no new lesions; pathological lymph nodes reduced in short axis to < 10 mm~PR = ≥ 30% decrease in sum of lesion diameters; no new lesions; no progression of non-target lesions~PD = Any of 20% increase in sum of lesion diameters; progression of non-target lesions; new lesions~SD = Neither CR, PR, nor PD"|At 12 weeks|Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome.|||Participants|||Count of Participants
2587976|NCT02312622|Secondary|Systemic (Non-CNS) Disease Control Rate (Cohort A and C)|"Systemic (ie, non-central nervous system) disease control (DC) rate by cohort is defined as the number of patients with complete response (CR) + partial response (PR) + stable disease (SD), divided by the total number of patients. The outcome will be reported as DC rate, a number without dispersion.~Response criteria are as follows. Note that any lesion < 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.~CR = Disappearance of all lesions, no new lesions; pathological lymph nodes reduced in short axis to < 10 mm~PR = ≥ 30% decrease in sum of lesion diameters; no new lesions; no progression of non-target lesions~PD = Any of 20% increase in sum of lesion diameters; progression of non-target lesions; new lesions~SD = Neither CR, PR, nor PD"|At 12 weeks|Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome.|||Participants|||Count of Participants
2587977|NCT02312622|Secondary|Overall Response Rate (Cohort A and C)|"Overall response by subject (OR) is defined as the lower assessment between the central nervous system response and the systemic response. Response is defined as either complete response (CR) or partial response (PR). The outcome is reported as the number and percentage of participants who achieve OR, a number without dispersion.~Response criteria are as follows. Note that any lesion < 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.~CR = Disappearance of all lesions, sustained for ≥ 4 weeks with no new lesions; clinical condition stable or improved~PR = ≥ 30% decrease in target lesion LD & no new lesions, sustained for ≥ 4 weeks; clinical condition stable or improved~PD = Any of: 20% increase in target lesion LD; increase in T2/FLAIR non-enhancing lesions; any new lesions; non-target progression; or clinical deterioration~SD = Neither PR or PD"|At 12 weeks|Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome.|||Participants|||Count of Participants
2587978|NCT02312622|Secondary|Overall Disease Control Rate (Cohort A and C)|"Overall disease control (DC) rate is defined as the sum in a cohort of the numbers of participants achieving complete response (CR); partial response (PR); or stable disease (SD), divided by the number of patients in that cohort. For this outcome, overall means all body systems, not just the central nervous system (CNS). The outcome is reported as DC rate, a number without dispersion.~Response criteria are as follows. Note that any lesion <10 mm in longest diameter (LD) is considered unchanged unless there is a ≥3 mm change in the sum of the LDs.~CR = Disappearance of all target lesions, sustained for ≥4 weeks with no new lesions; clinical condition stable or improved~PR = ≥30% decrease in target lesion LD & no new lesions, sustained for ≥ 4 weeks; clinical condition stable or improved~PD = Any of: 20% increase in target lesion LD; increase in T2/FLAIR non-enhancing lesions; any new lesions; non-target progression; or clinical deterioration~SD = Neither PR or PD"|At 12 weeks|Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome.|||participants|||Number
2587979|NCT02312622|Primary|Central Nervous System (CNS) Disease Control Rate (Cohort A and C)|"Central nervous system (CNS) disease control (DC) is defined as a complete response (CR); partial response (PR); or stable disease (SD). The outcome is reported as the number and percentage of participants who achieve DC, a number without dispersion.~Response criteria are as follows. Note that any lesion less than 10 mm in longest diameter (LD) is considered unchanged unless there is a ≥ 3 mm change in the sum of the LDs.~CR = Disappearance of all target lesions, sustained for ≥ 4 weeks with no new lesions; clinical condition stable or improved~PR = ≥ 30% decrease in target lesion LD and no new lesions, sustained for ≥ 4 weeks; clinical condition stable or improved~PD (progressive disease) = Any of 20% increase in target lesion LD; increase in T2/FLAIR non-enhancing lesions; any new lesions; non-target progression; or clinical deterioration~SD = Neither PR or PD"|At 12 weeks|Cohort B (metastatic small cell lung cancer, SCLC) is excluded per protocol from this outcome.|||Participants|||Count of Participants
2587980|NCT02312219|Secondary|Change in Arterial FDG Uptake (From Baseline) in the Aorta|"Arterial FDG Uptake provides a measure of inflammation in the artery wall.~TBR is target-to-background ratio (a measure of the ratio of the activity in the vessel wall divided by the blood background). A negative number for the change in TBR implies a reduction in activity over time.~The entire ascending aorta is used for this analysis.~The results are expressed as the change in the median value, of the TBR, from baseline to week 24"|baseline and 24 weeks||||TBR||Inter-Quartile Range|Median
2587981|NCT02312219|Primary|Change in Arterial FDG Uptake (From Baseline) in the Most Diseased Segment|"Arterial FDG Uptake provides a measure of inflammation in the artery wall.~TBR is target-to-background ratio (a measure of the ratio of the activity in the vessel wall divided by the blood background). A negative number for the change in TBR implies a reduction in activity over time.~The most diseased segment is the approx 1-cm section of the vessel with the highest activity at baseline.~The results are expressed as the change in the median value, of the TBR, from baseline to week 24"|baseline and 24 weeks||||TBR||Inter-Quartile Range|Median
2587982|NCT02312206|Primary|Time to Composite of All-cause Mortality or Cardiac Hospitalization|Time to all-cause mortality death occurring after the first infusion of study drug or cardiac hospitalization as adjudicated by the CEC occurring at least 91 days after first infusion of study drug through last subject last visit, whichever came first|Randomization until the date of death or cardiac hospitalization, up to 32 months|ITT Population|||Participants|||Count of Participants
2587983|NCT02312154|Primary|Global Aesthetic Improvement Scale (Subject)|The therapeutic outcome was assessed by patient self-assessment using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse|12 weeks||||scores on a scale||Standard Deviation|Mean
2587984|NCT02312154|Primary|Global Aesthetic Improvement Scale (Investigator)|The therapeutic outcome was assessed by investigator using the Global Aesthetic Improvement Scale (GAIS), which rates outcome on the following 5-point scale: 3, very much improved; 2, much improved; 1, improved; 0, no change; and -1, worse.|12 weeks||||scores on a scale||Standard Deviation|Mean
2587985|NCT02312154|Primary|Erythema Index|"We measured an erythema index by a mexameter device (Courage & Khazaka, Cologne, Germany).~The range of erythema index is 0~999 AU(Arbitrary Unit). The range of erythema index was 0 (as non-erythematous as possible) ~999 AU (most erythematous possible)"|12 weeks||||AU (arbitrary unit)||Standard Deviation|Mean
2587986|NCT02312154|Primary|Melanin Index|"We measured a melanin index by a mexameter device (Courage & Khazaka, Cologne, Germany).~The range of melanin index was 0 (as bright as possible) ~999 AU (Arbitrary Unit) (most dark possible)."|12 weeks||||AU (arbitrary unit)||Standard Deviation|Mean
2587987|NCT02312154|Primary|Elasticity|"We measured a elasticity by a reviscometer device (Courage & Khazaka, Cologne, Germany).~The range of elasticity was 0 (most elastic possible as) ~400 AU(Arbitrary Unit) (inelastic as possible)"|12 weeks||||AU (arbitrary unit)||Standard Deviation|Mean
2587988|NCT02312154|Primary|Hydration Level|"We measured a hydration level by a corneometer device (Courage & Khazaka, Cologne, Germany).~The range of hydration level was 0 (as dry as possible) ~120 AU (Arbitrary Unit)(most moist possible)"|12 weeks||||AU (arbitrary unit)||Standard Deviation|Mean
2587989|NCT02312063|Secondary|Correlation of Estimated Seafood Intake With HbA1c Reduction|Pearson's correlation coefficient of HbA1c reduction with estimated seafood intake|0-16 weeks||||pearson's correlation coefficient|||Number
2587990|NCT02312063|Primary|Correlation of Plasma Levels of EPA and DHA With HbA1c Reduction|Pearson's correlation coefficient of HbA1c reduction with plasma levels of EPA and DHA at baseline|0-16 weeks||||pearson's correlation coefficient|||Number
2587991|NCT02311972|Other Pre-specified|Exploratory Outcome: Caregiver Satisfaction and Ease of Use|Describe the caregiver satisfaction and ease of use for the InnerSense by using a provider questionnaire. Caregivers will rate the InnerSense feeding tube with traditional feeding tubes used in the Intensive Care Nursery.|First 24 hours of infant life.|||||||
2588121|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28|Serum samples for hsCRP were analyzed using a validated analytical assay. Reference range for measurement of CRP was 0.015 to 2.0 mg/dL. LLOQ for hsCRP was 0.03 mg/dL and limit of detection was 0.015 mg/dL.|Baseline, Day 2, 5, 10, 11, 28|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2587992|NCT02311972|Secondary|Pearson Correlation Coefficient Comparing Thermistor Abdominal Temperature to Esophageal Temperature in Each Infant in the Experimental Arm.|Temperatures measured by the abdomen thermistor will be compared with esophageal temperatures in each infant over 24 hours using pearson correlation coefficient.|Admission to 24 hours of infant life.|Intervention Group Only: Two infants with the InnerSense did not have skin temperatures dowloaded from the data logger due to data logger malfunction and one infant had a Squirrel monitor attached to the InnerSense tube that did not read or log temperatures. Therefore only data from 5 infants was available to analyze.|||Pearson Correlation Coefficient|||Number
2587993|NCT02311972|Secondary|Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 8 Hours of Infant Life|Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared at 8 hours to determine the percentage of hypothermia in both groups.|8 Hours of Infant Life||||Participants|||Count of Participants
2587994|NCT02311972|Secondary|Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 4 Hours of Infant Life|Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared at 4 hours to determine the percentage of hypothermia in both groups.|4 Hours of Infant Life||||Participants|||Count of Participants
2587995|NCT02311972|Secondary|Percentage of Infants With Hypothermic Temperatures (<36.5° C) at 1 Hour of Infant Life|Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared at 1 hour to determine the percentage of hypothermia in both groups.|1 Hour of Infant Life||||Participants|||Count of Participants
2587996|NCT02311972|Secondary|Percentage of Infants With Hypothermic Temperatures (<36.5° C) Upon Admission|Axillary temperatures for infants in the InnerSense group and infants in the standard of care group will be compared on admission to determine the percentage of hypothermia in both groups.|Admission||||Participants|||Count of Participants
2587997|NCT02311972|Primary|Mean Axillary Temperature at 4 Hours of Infant Life|The mean axillary temperature at 4 hours of age will be compared for infants in the InnerSense group and the standard of care group to determine if a significant difference is seen at 4 hours of life.|4 Hours of Infant Life||||Degrees Celsius||Standard Deviation|Mean
2587998|NCT02311972|Primary|Mean Axillary Admission Temperature|Mean axillary temperatures upon Admission from infants in the InnerSense group and the standard of care group will be compared to determine if a significant difference|Admission||||Degrees Celsius||Standard Deviation|Mean
2587999|NCT02311907|Secondary|Times to Onset of CTCAE Grade 3+ PN|Time to grade 3+ CIPN between GSH and placebo arms.|Up to 5 years from registration||||days||95% Confidence Interval|Median
2588000|NCT02311907|Secondary|Times to Onset of CTCAE Grade 2+ PN|Compare time to grade 2+ CIPN between GSH and placebo arms.|Up to 1 year|Number of Participants analyzed is 93 for Arm I due to error in date entered.|||days||Standard Error|Median
2588001|NCT02311907|Secondary|Percentage of Patients With Grade 2+ and Grade 3+ Paclitaxel/Carboplatin-induced (PCI) Peripheral Neuropathy (PN) According to the Common Terminology Criteria for Adverse Events (CTCAE) Neuropathy Scale|Proportion of grade 2+ and grade 3+ chemotherapy induced peripheral neuropathy (CIPN) at any time during or at the end of the TAXOL/CBDCA based chemotherapy between GSH and placebo arms. Neuropathy scale has grades 1 through 5 (1-mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening and Grade 5 Death related to AE).|Up to 1 year||||percentage of participants|||Number
2588002|NCT02311907|Secondary|Percentage of Patients Undergoing Dose Reductions Secondary to PCI PN|Proportion of patients requiring chemotherapy dose reductions secondary to TAXOL/CBDCA induced peripheral neuropathy between GSH and placebo arms.|Up to 1 year||||percentage of participants|||Number
2588003|NCT02311907|Secondary|Percentage of Patients Delaying PC Chemotherapy Secondary to PN|Patients delaying TAXOL/CBDCA secondary to peripheral neuropathy between GSH and placebo arms.|Up to 1 year||||Percentage of participants|||Number
2588004|NCT02311907|Secondary|Paclitaxel Acute Pain Syndrome Incidence and Severity Between GSH and Placebo Arms|Descriptive statistics will be used to describe TAXOL/CBDCA acute pain syndrome incidence/severity between GSH and placebo arms. Pain was scored on a scale from 0-10, where 0 = 'No aches or pains' and 10 = 'Aches or pains as bad as can be.'|Up to 1 year||||units on a scale||Full Range|Median
2588005|NCT02311907|Secondary|Change in Patient Reported Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Ovarian (FACT-O) and Patient Daily-symptom Questionnaires Over Time.|Quality of life was measured by FACT-O (on a 0 to 100 scale, higher scores represent better life quality) from baseline and at the end of TAXOL/CBDCA. The change in Quality of Life was calculated as the difference between baseline measure and end of treatment measure (with range from -100 to 100). A negative change represents a worsening in QOL from baseline to one year. Abbreviations used: Change from Baseline (chg from bsl)|Baseline to 1 year|FACT-O Change from Baseline to cycle 6 data available for 34 patients.|||units on a scale||Full Range|Median
2588006|NCT02311907|Secondary|Recurrence-free Survival (for Patients Without Clinical Evidence of Disease)|A log-rank test and a Kaplan-Meier curve will be used to compare the recurrence free survival between GSH and placebo arms (for ovarian/fallopian tube/primary peritoneal patients only).|Up to 1 year|Patients without clinical evidence of disease.|||Median survival time in days||95% Confidence Interval|Median
2588007|NCT02311907|Primary|Paclitaxel/Carboplatin (PC) Induced Peripheral Neuropathy as Assessed by EORTC QLQ-CIPN20 (European Organization for Research and Treatment of Cancer (EORTC), Quality of Life (QLQ), Chemotherapy Induced Peripheral Neuropathy 20 (CIPN20)).|The CIPN sensory subscale will be calculated by standard scoring algorithm and converted to 0-100 scale (higher scores indicated less symptoms and better quality of life). Generalized linear models (repeated measures analysis of variance [ANOVA] if data are complete) will be used to compare the CIPN between Glutathione (GSH) and placebo arms.|Every 28 day cycle, up to 6 cycles.||||Units on a scale 1-100||Standard Error|Least Squares Mean
2588008|NCT02311894|Secondary|Percentage of Participants With Adverse Events|Among participants who received at least one dose of study drug, those who reported at least one adverse event during study participation.|Baseline up to 1 year|Include all participants who received at least one dose of study drug.|||percentage of participants|||Number
2588158|NCT02310750|Primary|Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1||Baseline, 24 hours post-dose on Day 1|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.|||millisecond (msec)||Standard Deviation|Mean
2588009|NCT02311894|Secondary|Height Standard Deviation Score (SDS) at Months 6 and 12 (Change From Baseline)|Height Standard Deviation Score (SDS) allows for the comparison of a participants height to that of others in the same age group. Therefore, the average height for that age group will have the SDS of 0. In this study, the starting Height SDS score was ≤ −1.5 (≤ 5th percentile). Results are presented according to anti-GH antibody status (positive included all participants that were anti-GH antibody positive at least once post-baseline visit and anti-GH antibody negative population included all participants that were anti-GH antibody negative at all post-baseline visits.|Months 6, 12|All enrolled participants who received at least one dose of study drug and who had at least one post-baseline assessment|||SDS||Standard Deviation|Mean
2588010|NCT02311894|Secondary|Annualized Growth Velocity at Months 6 and 12 (Change From Baseline)|Annualized growth velocity is defined as (height - baseline height) / (date of height assessment - date of baseline)*365.25. Results are presented according to anti-GH antibody status (positive included all participants that were anti-GH antibody positive at least once post-baseline visit and anti-GH antibody negative population included all participants that were anti-GH antibody negative at all post-baseline visits).|Months 6, 12|All enrolled participants who received at least one dose of study drug and who had at least one post-baseline assessment|||cm/year||Standard Deviation|Mean
2588011|NCT02311894|Secondary|Percentage of Participants With Neutralizing Antibodies|Among participants who developed positive anti-GH antibody post-baseline, participants who were tested positive to neutralizing anti-GH antibody during study participation.|Baseline up to 1 year|Included only patients who had positive anti-GH antibody.|||percentage of participants|||Number
2588012|NCT02311894|Secondary|Percentage of Participants Who Exhibit Functional Growth Attenuation|Growth attenuation is defined as initial growth response greater than pretreatment velocity followed by reduction in growth response to below the pretreatment velocity in the subsequent 6- to 12-month treatment period or reaching ≤ 2 cm per year.|Baseline up to 1 year|All enrolled participants who received at least one dose of study drug and who had at least one post-baseline assessment|||percentage of participants||95% Confidence Interval|Number
2588013|NCT02311894|Primary|Percentage of Participants Who Develop Anti-GH Antibodies After Treatment With Nutropin AQ v1.1|Participants who were tested positive to anti-GH antibody after initiation of study treatment.|Baseline up to 1 year|All enrolled participants who received at least one dose of study drug and who had at least one post-baseline assessment|||percentage of participants||95% Confidence Interval|Number
2588014|NCT02311881|Secondary|Patient Global Assessment of Response to Therapy (PGART)|The PGART is a global assessment of the participant's response to therapy, was measured using on a 5 point Likert scale as follows: 0=None (no good at all, ineffective), 1= Poor (some effect, but unsatisfactory), 2= Fair (reasonable effect, but could be better), 3= Good (satisfactory effect with occasional episodes of pain and/or stiffness), 4= Excellent (ideal response, virtually pain-free). Mean PGART scores from 5 point Likert scale was calculated periodically (at Week 4, Week 8, Week 12) for the 12 week treatment period.|Week 4, Week 8, Week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practice issues were identified.|||score on a scale||Standard Deviation|Mean
2588015|NCT02311881|Secondary|Mean Change From Baseline in Chronic Pain Sleep Inventory (CPSI)|Chronic Pain Sleep Inventory (CPSI) was assessed, based on the three questions: CPSI-1-'Trouble falling asleep': How often the participant had trouble falling asleep? , CPSI-3-'Awakening due to pain at night': How often the subject was awakened by pain during the night, CPSI-4- Awakening due to pain in the morning': How often the participant was awakened by pain in the morning? The participants responded to these questions via 0-100mm VAS, ranging from 0 (never) to 100 (always). Sleep problem index (SPI) was calculated as mean of these three CPSI questions, ranging from 0 (never affected by pain during sleep) to 100 (always affected by pain during sleep).|Baseline, Week 4, Week 8, Week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participant randomized in a site where good clinical practice issues were identified.|||mm||Standard Deviation|Mean
2588016|NCT02311881|Secondary|Mean Number of Rescue Medication Pills Taken Per Day up to 12 Weeks|Participants recorded use of rescue medication daily in their patient diary. The mean number of doses of rescue medications taken per day during the 12-week treatment period was calculated.|every day up to 12 weeks|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participant randomized in a site where good clinical practice issues were identified.|||number of rescue medication pills/day||Standard Deviation|Mean
2588017|NCT02311881|Secondary|Mean Change From Baseline in Daily Pain, Daily Stiffness and Pain/Stiffness (Composite) at Week 12|Participants assessed their daily pain and stiffness each morning (upon awakening) during the 12-week treatment period using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain / no stiffness) to 10 (extreme pain / extreme stiffness). Composite daily pain/stiffness score was calculated as sum of scores of pain and stiffness each morning divided by 2, ranging from 0 (no pain/stiffness) to 10 (extreme pain/stiffness). The mean of pain, mean of stiffness, and mean pain /stiffness composite score was calculated. Change from baseline was calculated as the difference between Daily Pain, stiffness and composite score each morning with that at baseline and was presented per week. A negative change from Baseline indicated improvement.|Baseline, Week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practices issues were identified.|||score on a scale||Standard Deviation|Mean
2588122|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: High Sensitivity C-reactive Protein (hsCRP) Concentration in Serum at Baseline|Serum samples for hsCRP were analyzed using a validated analytical assay. Reference range for measurement of CRP was 0.015 to 2.0 mg/dL. LLOQ for hsCRP was 0.03 mg/dL and limit of detection was 0.015 mg/dL.|Baseline|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2588018|NCT02311881|Secondary|Number of Participants Classified as Responder|"A participant was considered a responder if his/her improvement from baseline (change from baseline at week 12) satisfied at least one of the two criteria high' or 'moderate' improvement as follows:- High improvement: 50% improvement from baseline in the last available WOMAC pain score or 60% improvement from baseline in the last available WOMAC physical function score. Moderate improvement: Fulfills two out of three criteria: 30% improvement from baseline in the last available WOMAC Pain score, 20% improvement from baseline in the last available WOMAC Physical Function score, 25% improvement from baseline in the last available GPAOA."|Baseline, Week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practice issues were identified.|||participants|||Number
2588019|NCT02311881|Secondary|Mean Change From Baseline in Global Patient Assessment of Arthritis (GPAOA)|"Participants performed an instantaneous GPAOA via a 0-100mm VAS, ranging from 0 (best ever) to 100 (worst ever) with respect to With respect to your arthritis condition, how would you describe yourself now? GPAOA was calculated periodically during the 12 week treatment period."|Baseline, Week 4, Week 8, Week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practice issues were identified.|||mm||Standard Deviation|Mean
2588020|NCT02311881|Secondary|Time-weighted Mean Change From Baseline in WOMAC Total Index Through Week 12 of Treatment|The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. The Total Index Score included the WOMAC Pain Score (5 questions about pain where: 0=no pain to 100=extreme pain), the WOMAC Physical Function score (17 questions about the difficulty of daily activities where: 0=no difficulty to 100=extreme difficulty) and the WOMAC Stiffness Score (2 questions about stiffness where: 0=no stiffness to 100=extreme stiffness). WOMAC Total Index was calculated at baseline and each time point as sum of scores of all 24 WOMAC questions divided by 2400, ranging from 0 (no pain/difficulty/stiffness) to 1 (extreme pain/ difficulty/stiffness). Change from baseline was calculated as WOMAC Total Index at specific time point minus WOMAC Total Index at baseline. A negative change from Baseline indicated improvement.|Baseline up to week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practices issues were identified.|||mm||Standard Deviation|Mean
2588021|NCT02311881|Secondary|Time Weighted Mean Change From Baseline in WOMAC Stiffness Through Week 12 of Treatment|The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. WOMAC stiffness was measured using VAS ranging from 0mm (no stiffness) to 100mm (maximum stiffness) at baseline and at week 1, 2, 4, 8, and 12. Lower values represent a better outcome. At each time point the assessment included 2 WOMAC stiffness categories: 1- after awakening in the morning; 2- later in the day. Mean WOMAC stiffness was calculated for baseline and each time point (sum of scores for 2 stiffness categories divided by 2). Change from baseline was calculated for each visit as mean WOMAC stiffness subscale score at specific time point minus mean WOMAC stiffness subscale score at baseline. A negative change from Baseline indicated improvement. The time-weighted mean change from baseline was calculated as area under the curve of change from baseline divided by nominal time of the last on-therapy visit (week 12) from randomization (baseline).|Baseline up to week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practices issues were identified.|||mm||Standard Deviation|Mean
2588022|NCT02311881|Secondary|Time Weighted Mean Change From Baseline in WOMAC Physical Function Through Week 12 of Treatment|The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. WOMAC Physical function was measured using VAS ranging from 0mm (no difficulty) to 100mm (extreme difficulty) at baseline and at week 1, 2, 4, 8, and 12. Lower values represent a better outcome. At each time point the assessment included 17 WOMAC Physical function categories. Mean WOMAC Physical function was calculated for baseline and each time point (sum of scores for 17 physical function categories divided by 17). Change from baseline was calculated for each visit as mean WOMAC physical function subscale score minus mean baseline WOMAC physical function subscale score. A negative change from Baseline indicated improvement. The time-weighted mean change was calculated as the area under the curve of change from baseline divided by the nominal time of the last on-therapy visit (week 12) from randomization (baseline).|Baseline up to Week 12|Analysis for this outcome was conducted on mITT population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practices issues were identified.|||mm||Standard Deviation|Mean
2588023|NCT02311881|Primary|Time-weighted Mean Change From Baseline in Western Ontario McMaster (WOMAC) Pain Through Week 12 of Treatment|The WOMAC Osteoarthritis Index is a 24-item questionnaire that assesses pain, physical function, and stiffness in the target joint. WOMAC Pain was measured using visual analogue scale (VAS) ranging from 0mm (no pain) to 100mm (extreme pain) at baseline and at week 1, 2, 4, 8, and 12. Lower values represent a better outcome. At each time point the assessment included 5 WOMAC Pain items: 1-walking on flat, 2-going up down stairs, 3-at night while in bed, 4-sitting or lying; 5-standing upright. Mean WOMAC Pain subscale score was calculated at each visit as the sum of 5 pain category scores divided by 5. Change from baseline was calculated for each visit as the mean WOMAC Pain subscale score minus the mean baseline WOMAC Pain subscale score. A negative change from Baseline indicated improvement. The time-weighted mean change was calculated as the area under the curve of change from baseline divided by the nominal time of the last on-therapy visit (week 12) from randomization (baseline).|Baseline up to week 12|Modified intent to treat (mITT) population which included all participants included in the ITT population (included all randomized participants that received the study treatment & had at least one post-baseline efficacy assessment), except participants randomized in a site where good clinical practice issues were identified.|||millimeter(mm)||Standard Error|Least Squares Mean
2588025|NCT02311478|Primary|Evaluate Changes in Bleeding Duration Among Women Initiating the Copper T380 IUD During the 90 Days Prior to Initiation Compared to Two 90 Periods After IUD Insertion.|Evaluate bleeding duration among women initiating the copper T380 IUD during the 90 days prior to initiation compared to two 90 periods after IUD insertion. Women will track bleeding after the insertion of the T380A IUD for 180 days. Participants will be contacted monthly to collect data.|3 months prior to insertion, month 1-month 3 , month 4-month 6|Healthy Women ages 18-40 with menstrual cycle lengths between 21 and 35 days and menses lasting 3 to 7 days, and completed follow up were eligible for participation and analysis. Women were excluded if they reported use of any hormonal contraception in the previous 3 months.|||days of bleeding||95% Confidence Interval|Mean
2588026|NCT02311309|Secondary|Lowest Hemoglobin|lowest peroperative hemoglobin concentration|one day|||||||
2588027|NCT02311309|Secondary|Preoperative Anemia|proportion of patients with preoperative anemia|one day|||||||
2588028|NCT02311309|Secondary|Transfusions|transfusion pattern in the whole cohort|one day||||number of participants|||Number
2588029|NCT02311309|Primary|Unanticipated Bleeding|From arrival in operating room until the patients leave post anesthesia care unit|one day||||percentage of participants|||Number
2588030|NCT02311153|Secondary|Presence or Absence of Airway Complications||Start of surgery through hospital discharge (approximately 6 hours)|Participants that started the study were analyzed.|||Participants|||Count of Participants
2588031|NCT02311153|Secondary|Post-op Pain Med Requirements|Recording pain medications given to patient as noted in the recovery room records and medication administration record|48 hour medicine requirement|Participants that started the study were analyzed. Data was missing for 5 participants in the Endotracheal intubation arm and 7 participants in the Laryngeal mask airway arm.|||Participants|||Count of Participants
2588032|NCT02311153|Secondary|Presence of Laryngeal Spasm|As recorded in anesthesia care record|From start of anesthesia through hospital discharge (approximately 6 hours)||||Participants|||Count of Participants
2588033|NCT02311153|Secondary|Recovery Time in Minutes|Minutes spent in recovery room as recorded in the recovery room record|time spent in recovery room after surgery (approximately 4 hours)|Participants that started the study were analyzed.|||minutes||Full Range|Mean
2588034|NCT02311153|Secondary|Anesthesia Time in Minutes|Start and stop time of anesthesia as recorded in anesthesia record|beginning and end of anesthesia (approximately 2 hours)||||minutes||Full Range|Mean
2588035|NCT02311153|Primary|Number of Participants With Presence or Absence of Blood/Secretions in Trachea and Larynx Based on Soiling Score|Presence or absence of blood/secretions as noted in trachea and larynx. Patients were evaluated based on a soiling score completed by the surgeon, ranging from 0 (no contamination or soilage) to 3 (contamination of the tube/bloody secretions).|intraoperative, within about 1 hour|Participants that started the study were analyzed. Data was missing for 1 participant in each arm.|||Participants|||Count of Participants
2588036|NCT02310789|Secondary|Change Sweat Chloride Production|Sweat chloride concentration was measured via the traditional sweat collection methods using the pilocarpine stimulation with the Macroduct device.|Up to 79 days|Participants with available data were included in the analysis.|||percent change||Standard Deviation|Mean
2588037|NCT02310789|Primary|Change in Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)-Dependent Sweat Rate|CFTR-dependent sweat rate (C-sweat) was analyzed using a linear mixed model, combining on- and off-ivacaftor data.|Up to 79 days|Participants with available data were included in the analysis.|||percent change||Standard Deviation|Mean
2588038|NCT02310776|Primary|Ratio of Lesions Detected With Automated Breast Ultrasound (ABVS) Compared to the Standard of Care Handheld (HH) Breast Ultrasound (US)|Solid lesions found on whole breast 3D supine automated breast ultrasound are compared in number and identity with solid lesions found using high resolution standard of care handheld breast ultrasound performed by physicians|Time for performance of ABVS was measured separately from interpretation time. Time for performance of real time HH whole breast US was also measured. For HH US physician performed, performance included interpretation.|Each participant was evaluated based on Breast Imaging-Reporting and Data System (BI-RADS) assessment for Automated and Handheld breast ultrasound exams. If participant had more than one lesion, each lesion was assessed and listed separately and if a participant did not have a lesion, she was entered once.|||Detection ratio of lesions|Participants|95% Confidence Interval|Number
2588039|NCT02310763|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Serum Concentration (AUClast) of Domagrozumab|AUClast was calculated by linear/log trapezoidal method. AUCtau was obtained by linear/log trapezoidal method. AUClast was assessed to fully characterize PK data and it was only assessed on the first 12 participants enrolled in the study who were required to complete additional PK visits.|At predose, end of 2-hour infusion, 6 hours and 168 hours since start of infusion on Weeks 1, 13, 17, 29, 33 and 45|Data were not collected and analyzed due to study early termination.||||||
2588040|NCT02310763|Secondary|Number of Participants With Anti-drug Antibodies (ADA) Development by Week 97|The criterion for positive result of ADA samples was ADA titer >=1.88.|Baseline, every 4 weeks from Week 5 to Week 97 visit or early termination|This analysis population included all participants who received at least 1 dose of investigational drug. Number analyzed refers to the number of participants evaluable for specified rows of time points.|||Participants|||Count of Participants
2588041|NCT02310763|Secondary|Volume of Distribution at Steady State (Vss) of Domagrozumab for Participants in Sequence 2 Required for Additional PK Assessment|Vss was calculated by CL*MRT, where MRT was the mean residence time. Vss was assessed to fully characterize PK data.|At predose, end of 2-hour infusion, 6 hours and 168 hours since start of infusion on Week 45|Data were not collected and analyzed due to study early termination.||||||
2588042|NCT02310763|Secondary|Clearance (CL) of Domagrozumab|CL was calculated by Dose/AUCtau. The CL was assessed to fully characterize PK data and it was only assessed on the first 12 participants enrolled in the study who were required to complete additional PK visits.|At predose, end of 2-hour infusion, 6 hours and 168 hours since start of infusion on Weeks 13, 29 and 45|This analysis population included participants who were among the first 12 participants enrolled in the study, had received at least 1 dose of domagrozumab and in whom at least 1 of the PK parameters of interest was calculated. Participants without contributing to the summary statistics are excluded below.|||Milliliter/hr/kilogram(mL/hr/kg)||Full Range|Median
2588043|NCT02310763|Secondary|Average Serum Concentration Over the Dosing Interval (Cav) of Domagrozumab|Cav was calculated by AUCtau/tau. The Cav was assessed to fully characterize PK data and it was only assessed on the first 12 participants enrolled in the study who were required to complete additional PK visits.|At predose, end of 2-hour infusion, 6 hours and 168 hours since start of infusion on Weeks 1, 13, 17, 29, 33 and 45|This analysis population included participants who were among the first 12 participants enrolled in the study, had received at least 1 dose of domagrozumab and in whom at least 1 of the PK parameters of interest was calculated. Participants without contributing to the summary statistics are excluded below.|||ug/mL||Full Range|Median
2588044|NCT02310763|Secondary|Area Under the Serum Concentration-time Curve Over the Dosing Interval Tau (AUCtau) of Domagrozumab|The dosing interval tau was 672 hours (4 weeks). AUCtau was obtained by linear/log trapezoidal method. The AUCtau was assessed to fully characterize PK data and it was only assessed on the first 12 participants enrolled in the study who were required to complete additional PK visits.|At predose, end of 2-hour infusion,6 hours and 168 hours since start of infusion on Weeks 1, 13, 17, 29, 33 and 45|This analysis population included participants who were among the first 12 participants enrolled in the study, had received at least 1 dose of domagrozumab and in whom at least 1 of the PK parameters of interest was calculated. Participants without contributing to the summary statistics are excluded below.|||Microgram*hour per milliliter (ug*hr/mL)||Full Range|Median
2588045|NCT02310763|Secondary|Terminal Half-life (t1/2) of Domagrozumab for Participants in Sequence 2 After the Last Dose of Domagrozumab|t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Participants in Sequence 2 received the last dose of domagrozumab at Week 45.|At predose, end of 2-hour infusion and 6 hours since start of infusion at Week 45|Data were not collected and analyzed due to study early termination.||||||
2588046|NCT02310763|Secondary|Time for Cmax (Tmax) of Domagrozumab|Tmax was observed directly from the data.|Every 4 weeks on dosing day (predose, end of 2-hour infusion and 6 hours since start of infusion) from Week 1 to Week 96 for Sequence 1; from Week 1 to Week 48 for Sequence 2; from Week 49 to Week 96 for Sequence 3|Data were not collected and analyzed due to study early termination.||||||
2588047|NCT02310763|Secondary|Maximum Serum Concentration (Cmax) of Domagrozumab|Cmax was observed directly from data.|Every 4 weeks on dosing day (predose, end of 2-hour infusion and 6 hours since start of infusion) from Week 1 to Week 96 for Sequence 1; from Week 1 to Week 48 for Sequence 2; from Week 49 to Week 96 for Sequence 3|Data were not collected and analyzed due to study early termination.||||||
2588048|NCT02310763|Secondary|Trough (Pre-dose) Serum Concentration (Ctrough) of Domagrozumab|Ctrough was observed directly from data.|Every 4 weeks on dosing day (predose, end of 2-hour infusion and 6 hours since start of infusion) from Week 1 to Week 96 for Sequence 1; from Week 1 to Week 48 for Sequence 2; from Week 49 to Week 96 for Sequence 3|This analysis population included all participants who received at least 1 dose of domagrozumab and in whom at least 1 concentration value was reported. Participants without contributing to the summary statistics are excluded below. Number analyzed refers to number of participants evaluable for specified rows of timepoints.|||Microgram per milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2588049|NCT02310763|Secondary|Ctrough,(GDF-8) for Participants of Sequence 3 in Period 2|GDF-8, also called myostatin, is the target of domagrozumab. Ctrough,(GDF-8) was observed directly from data.|Every 4 weeks on dosing day (predose, end of 2-hour infusion and 6 hours since start of infusion) from Week 49 to Week 96|This analysis population included all enrolled participants in Sequence 3 and in whom at least 1 GDF-8 concentration value was reported. Participants without contributing to the summary statistics are excluded below.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2588050|NCT02310763|Secondary|Trough Serum Concentration of GDF-8 (Ctrough,(GDF-8)) for Participants Receiving Domagrozumab in Period 1|GDF-8, also called myostatin, is the target of domagrozumab. Ctrough,(GDF-8) was observed directly from data.|Every 4 weeks on dosing day (at predose, end of 2-hour infusion and 6 hours since start of infusion) from Week 1 to Week 48|This analysis population included all enrolled participants in Sequences 1 and 2 in whom at least 1 GDF-8 concentration value was reported. Participants without contributing to the summary statistics are excluded below.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2588051|NCT02310763|Secondary|Concentration of Growth Differentiation Factor 8 (GDF-8) at Time 0 (Pre-dose),(C0(GDF-8) )|GDF-8, also called myostatin, is the target of domagrozumab. C0(GDF-8) was observed directly from data.|Predose on Day 1 of Week 1|This analysis population included all enrolled participants in whom at least 1 GDF-8 concentration value was reported. Participants without contributing to the summary statistics are excluded below.|||Nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2588052|NCT02310763|Secondary|Change From Baseline in Whole Thigh Muscle Volume Index Through Week 97|The thigh muscle volume index was derived from the thigh muscle volume measurements as the fraction of total thigh tissue that was the lean muscle.|Baseline, Weeks 17, 33, 49 and 97|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of time points.|||Percent of whole thign volume||95% Confidence Interval|Mean
2588053|NCT02310763|Secondary|Change From Baseline in Whole Thigh Muscle Volume Through Week 97|The whole thigh muscle volume was measured by the proton density weighted sequence with magnetic resonance imaging (MRI) which was used to segment the entire thigh region into 3 primary regions for volumetric measure including 1) muscle; 2) inter/intra-muscular fat, 3) subcutaneous fat.|Baseline, Weeks 17, 33, 49 and 97|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of time points.|||Cubic centimeters||95% Confidence Interval|Mean
2588123|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56|Serum samples for IP-10 were analyzed using a validated analytical assay. Lower limit of quantification (LLOQ) for IP-10 was 10 pg/mL.|Baseline, Day 2, 5, 7, 14, 21, 28, 29, 35, 56|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||pg/mL||Standard Deviation|Mean
2588054|NCT02310763|Secondary|Percent Change From Baseline as Compared to Placebo in Whole Thigh Muscle Volume Index by Weeks 17, 33 and 49|The thigh muscle volume index was derived from the thigh muscle volume measurements as the fraction of total thigh tissue that was the lean muscle. MMRM was used to analyze the percent change from baseline for domagrozumab compared to placebo. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Weeks 17, 33 and 49|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Percent change of muscle volume index||Standard Error|Least Squares Mean
2588055|NCT02310763|Secondary|Percent Change From Baseline in Whole Thigh Muscle Volume as Compared to Placebo by Weeks 17, 33 and 49|The whole thigh muscle volume was measured by the proton density weighted sequence with magnetic resonance imaging (MRI) which was used to segment the entire thigh region into 3 primary regions for volumetric measure including 1) muscle; 2) inter/intra-muscular fat, 3) subcutaneous fat. MMRM was used to analyze the percent change from baseline for domagrozumab compared to placebo. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Weeks 17, 33 and 49|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of time points.|||Percent change of thigh muscle volume||Standard Error|Least Squares Mean
2588056|NCT02310763|Secondary|Change From Baseline on Muscle Strength at Weeks 17, 33 and 49 in Pre-specified Subset (Baseline 4SC >8 Seconds)|Muscle strength was quantified by means of a handheld dynamometer. The following muscle groups were evaluated: knee extension, elbow flexion, hip abduction, elbow extension and shoulder abduction. Change from baseline on muscle strength in all participants with baseline 4SC >8 seconds are presented below.|Baseline, Weeks 17, 33 and 49|This analysis population included all participants (with baseline 4SC >8 seconds) randomized and who had received at least 1 dose of randomized treatment. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Kilograms||95% Confidence Interval|Mean
2588057|NCT02310763|Secondary|Change From Baseline on Muscle Strength at Weeks 17, 33 and 49 in Pre-specified Subset (Baseline 4SC >=3.5 Seconds and <=8 Seconds)|Muscle strength was quantified by means of a handheld dynamometer. The following muscle groups were evaluated: knee extension, elbow flexion, hip abduction, elbow extension and shoulder abduction. Change from baseline on muscle strength in all participants with baseline 4SC >=3.5 seconds and <=8 seconds are presented below.|Baseline, Weeks 17, 33 and 49|This analysis population included all participants (with baseline 4SC >=3.5 seconds and <=8 seconds ) randomized and who had received at least 1 dose of randomized treatment. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Kilograms||95% Confidence Interval|Mean
2588058|NCT02310763|Secondary|Change From Baseline on Muscle Strength at Weeks 17, 33 and 49 in Pre-specified Subset (Baseline 4SC <3.5 Seconds)|Muscle strength was quantified by means of a handheld dynamometer. The following muscle groups were evaluated: knee extension, elbow flexion, hip abduction, elbow extension and shoulder abduction. Change from baseline on muscle strength in all participants with baseline 4SC <3.5 seconds are presented below.|Baseline, Weeks 17, 33 and 49|This analysis population included all participants (with baseline 4SC <3.5 seconds) randomized and who had received at least 1 dose o f randomized treatment. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Kilograms||95% Confidence Interval|Mean
2588059|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on 6MWD at Week 49 in Pre-specified Subsets|6MWD evaluated ambulation ability by measuring the distance walked in 6 minutes. A subset analysis was performed by categorizing participants into 3 subsets according to the baseline 4SC time: 1) <3.5 seconds, 2)>=3.5 seconds and <=8 seconds, 3) >8 seconds. MMRM was used to analyze the change from baseline on 6MWD for domagrozumab compared to placebo in subsets. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Week 49|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Meters||Standard Error|Least Squares Mean
2588060|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on 6MWD at Week 33 in Pre-specified Subsets|6MWD evaluated ambulation ability by measuring the distance walked in 6 minutes. A subset analysis was performed by categorizing participants into 3 subsets according to the baseline 4SC time: 1) <3.5 seconds, 2)>=3.5 seconds and <=8 seconds, 3) >8 seconds. MMRM was used to analyze the change from baseline on 6MWD for domagrozumab compared to placebo in subsets. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Week 33|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Meters||Standard Error|Least Squares Mean
2588124|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28|Serum samples for IP-10 were analyzed using a validated analytical assay. LLOQ for IP-10 was 10 pg/mL.|Baseline, Day 2, 5, 10, 11, 28|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||pg/mL||Standard Deviation|Mean
2588900|NCT02299869|Primary|Comfort Preference|Participant's subjective preference for comfort on a 3 point Likert Scale. 1=prefer CVI-test lens, 2=prefer Competitor-control lens, 3=no preference|Baseline||||participants|||Number
2588061|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on 6MWD at Week 17 in Pre-specified Subsets|6MWD evaluated ambulation ability by measuring the distance walked in 6 minutes. A subset analysis was performed by categorizing participants into 3 subsets according to the baseline 4SC time: 1) <3.5 seconds, 2)>=3.5 seconds and <=8 seconds, 3) >8 seconds. MMRM was used to analyze the change from baseline on 6MWD for domagrozumab compared to placebo in subsets. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Week 17|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Meters||Standard Error|Least Squares Mean
2588062|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on PUL Overall Score at Week 49 in Pre-specified Subsets|The PUL was used to assess motor performance of the upper limb. The PUL scale includes 22 items; an entry item defining the starting functional level, and 21 items subdivided into three levels: shoulder (4 items), middle (9 items) and distal (8 items).Scoring options per item may not be uniform and may vary from 0-1 and 0-6, according to the performance, with higher values corresponding to better performance. A total maximum score of 74 is achieved by adding the individual level scores. A subset analysis was performed by categorizing participants into 3 subsets according to the baseline 4SC time. MMRM was used to analyze the change from baseline.The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Week 49|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Units on a scale||Standard Error|Least Squares Mean
2588063|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on PUL Overall Score at Week 33 in Pre-specified Subsets|The PUL was used to assess motor performance of the upper limb. The PUL scale includes 22 items; an entry item defining the starting functional level, and 21 items subdivided into three levels: shoulder (4 items), middle (9 items) and distal (8 items).Scoring options per item may not be uniform and may vary from 0-1 and 0-6, according to the performance, with higher values corresponding to better performance. A total maximum score of 74 is achieved by adding the individual level scores. A subset analysis was performed by categorizing participants into 3 subsets according to the baseline 4SC time. MMRM was used to analyze the change from baseline.The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Week 33|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Units on a scale||Standard Error|Least Squares Mean
2588064|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on PUL Overall Scores at Week 17 in Pre-specified Subsets|The PUL was used to assess motor performance of the upper limb. The PUL scale includes 22 items; an entry item defining the starting functional level, and 21 items subdivided into three levels: shoulder (4 items), middle (9 items) and distal (8 items). Scoring options per item may not be uniform and may vary from 0-1 and 0-6, according to the performance, with higher values corresponding to better performance. A total maximum score of 74 is achieved by adding the individual level scores. A subset analysis was performed by categorizing participants into 3 subsets according to the baseline 4SC time. MMRM was used to analyze the change from baseline .The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Week 17|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Units on a scale||Standard Error|Least Squares Mean
2588065|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on NSAA at Week 49 in Pre-specified Subsets|The NSAA is a 17-item test that measured gross motor function. Each individual item received a score of 0-unable to perform independently, 1-able to perform with assistance, or 2-able to perform without assistance. A total score was achieved by summing all the individual items. The total score could range from 0 to 34 (fully-independent function). A subset analysis was performed by categorizing participants into 3 subsets according to the baseline 4SC time: 1) <3.5 seconds, 2)>=3.5 seconds and <=8 seconds, 3) >8 seconds. MMRM was used to analyze the change from baseline for domagrozumab compared to placebo in subsets. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Week 49|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Units on a scale||Standard Error|Least Squares Mean
2588098|NCT02310763|Primary|Number of Participants With Vital Signs Findings Reported as SAEs by Week 49|Vital signs evaluation included supine systolic and diastolic blood pressure (BP), pulse rate, and respiratory rate. An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Investigators determined which vital signs findings were reported as SAEs.|Baseline to Week 49 visit|This analysis population included all participants who received at least 1 dose of investigational drug. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2588066|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on NSAA at Week 33 in Pre-specified Subsets|The NSAA is a 17-item test that measured gross motor function. Each individual item received a score of 0-unable to perform independently, 1-able to perform with assistance, or 2-able to perform without assistance. A total score was achieved by summing all the individual items. The total score could range from 0 to 34 (fully-independent function). A subset analysis was performed by categorizing participants into 3 subsets according to the baseline 4SC time: 1) <3.5 seconds, 2)>=3.5 seconds and <=8 seconds, 3) >8 seconds. MMRM was used to analyze the change from baseline for domagrozumab compared to placebo in subsets. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Week 33|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Units on a scale||Standard Error|Least Squares Mean
2588067|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on NSAA at Week 17 in Pre-specified Subsets|The NSAA is a 17-item test that measured gross motor function. Each individual item received a score of 0-unable to perform independently, 1-able to perform with assistance, or 2-able to perform without assistance. A total score was achieved by summing all the individual items. The total score could range from 0 to 34 (fully-independent function). A subset analysis was performed by categorizing participants into 3 subsets according to the baseline 4SC time: 1) <3.5 seconds, 2)>=3.5 seconds and <=8 seconds, 3) >8 seconds. MMRM was used to analyze the change from baseline for domagrozumab compared to placebo in subsets. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Week 17|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Units on a scale||Standard Error|Least Squares Mean
2588068|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on FVC at Week 49 in Pre-specified Subsets|FVC was measured by spirometry to evaluate respiratory muscle function. A subset analysis was performed by categorizing participants into 3 subsets according to the baseline 4SC time: 1) <3.5 seconds, 2)>=3.5 seconds and <=8 seconds, 3) >8 seconds. MMRM was used to analyze the change from baseline on FVC for domagrozumab compared to placebo in subsets. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Week 49|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Liters||Standard Error|Least Squares Mean
2588069|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on FVC at Week 33 in Pre-specified Subsets|FVC was measured by spirometry to evaluate respiratory muscle function. A subset analysis was performed by categorizing participants into 3 subsets according to the baseline 4SC time: 1) <3.5 seconds, 2)>=3.5 seconds and <=8 seconds, 3) >8 seconds. MMRM was used to analyze the change from baseline on FVC for domagrozumab compared to placebo in subsets. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Week 33|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Liters||Standard Error|Least Squares Mean
2588070|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on FVC at Week 17 in Pre-specified Subsets|FVC was measured by spirometry to evaluate respiratory muscle function. A subset analysis was performed by categorizing participants into 3 subsets according to the baseline 4SC time: 1) <3.5 seconds, 2)>=3.5 seconds and <=8 seconds, 3) >8 seconds. MMRM was used to analyze the change from baseline on FVC for domagrozumab compared to placebo in subsets. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Week 17|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Liters||Standard Error|Least Squares Mean
2588071|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on 4SC at Week 49 in Pre-specified Subsets|The 4SC quantified the time required for a participant to ascend 4 standard steps. A subset analysis was performed by categorizing participants into 3 subsets according to the baseline 4SC time: 1) <3.5 seconds, 2)>=3.5 seconds and <=8 seconds, 3) >8 seconds. MMRM was used to analyze the change from baseline for domagrozumab compared to placebo in subsets. The baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Week 49|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Seconds||Standard Error|Least Squares Mean
2588125|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Baseline|Serum samples for IP-10 were analyzed using a validated analytical assay. Lower limit of quantification (LLOQ) for IP-10 was 10 pg/mL.|Baseline|Pharmacodynamic (PD) analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest.|||picogram per milliliter (pg/mL)||Standard Deviation|Mean
2588072|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on 4SC at Week 33 in Pre-specified Subsets|The 4SC quantified the time required for a participant to ascend 4 standard steps. A subset analysis was performed by categorizing participants into 3 subsets according to the baseline 4SC time: 1) <3.5 seconds, 2)>=3.5 seconds and <=8 seconds, 3) >8 seconds.MMRM was used to analyze the change from baseline for domagrozumab compared to placebo in subsets. The baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Week 33|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Seconds||Standard Error|Least Squares Mean
2588073|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on 4SC at Week 17 in Pre-specified Subsets|The 4SC quantified the time required for a participant to ascend 4 standard steps. A subset analysis was performed by categorizing participants into 3 subsets according to the baseline 4SC time: 1) <3.5 seconds, 2)>=3.5 seconds and <=8 seconds, 3) >8 seconds. MMRM was used to analyze the change from baseline for domagrozumab compared to placebo in subsets. The baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Week 17|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Seconds||Standard Error|Least Squares Mean
2588074|NCT02310763|Secondary|Change From Baseline to Week 97 on 6MWD for Participants in Sequence 1 Compared to the Natural History Control Group|6MWD evaluated ambulation ability by measuring the distance walked in 6 minutes. MMRM was used to analyze the change from baseline on 6MWD for domagrozumab compared to the natural history control group. The natural history control group was established by filtering the CINRG natural history database. Participants who met the following requirements at baseline and had evaluable 6MWD data on Week 97 were included in this group: 1) age: 6 to <16 years; 2)treatment of glucocorticoid steroids >=6 months prior to baseline and continuous use until the latest visit week; 3) 4SC: 2-15.9 seconds; 4) participants who were ambulatory at baseline; 5) LVEF: >=55% or missing.|Baseline, Week 97|This analysis population included all participants randomized in Sequence 1 and received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||Meters||Standard Error|Least Squares Mean
2588075|NCT02310763|Secondary|Change From Baseline to Week 49 on 6MWD for Participants in Sequence 3 Compared to the Natural History Control Group|6MWD evaluated ambulation ability by measuring the distance walked in 6 minutes. MMRM was used to analyze the change from baseline on 6MWD for the natural history control group compared to placebo group (Sequence 3). This MMRM was established to assess the appropriateness on using the natural history control group as a comparator. The natural history control group was established by filtering the CINRG natural history database. Participants who met the following requirements at baseline and had evaluable 6MWD data on Week 49 were included in this group: 1) age: 6 to <16 years; 2)treatment of glucocorticoid steroids >=6 months prior to baseline and continuous use until the latest visit week; 3) 4SC: 2-15.9 seconds; 4) participants who were ambulatory at baseline; 5) LVEF: >=55% or missing.|Baseline, Week 49|This analysis population included all participants randomized in Sequence 3 and received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||Meters||Standard Error|Least Squares Mean
2588076|NCT02310763|Secondary|Change From Baseline to Week 97 on NSAA for Participants in Sequence 1 Compared to the Natural History Control Group|The NSAA is a 17-item test that measured gross motor function. The total score could range from 0 to 34 (fully-independent function). MMRM was used to analyze the change from baseline on NSAA for domagrozumab compared to the natural history control group. The natural history control group was established by filtering the CINRG natural history database. Participants who met the following requirements at baseline and had evaluable NSAA data on Week 97 were included in this group: 1) age: 6 to <16 years; 2) treatment of glucocorticoid steroids >=6 months prior to baseline and continuous use until the latest visit week; 3) 4SC: 2-15.9 seconds; 4 participants who were ambulatory at baseline; 5) LVEF: >=55% or missing.|Baseline, Week 97|This analysis population included all participants randomized in Sequence 1 and received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Error|Least Squares Mean
2588077|NCT02310763|Secondary|Change From Baseline to Week 49 on NSAA for Participants in Sequence 3 Compared to the Natural History Control Group|The NSAA is a 17-item test that measured gross motor function. A total score could range from 0 to 34 (fully-independent function). MMRM was used to analyze the change from baseline on NSAA for the natural history control group compared to placebo group (Sequence 3). This MMRM was established to assess the appropriateness on the using natural history control group as a comparator. The natural history control group was established by filtering the CINRG natural history database. Participants who met the following requirements at baseline and had evaluable NSAA data on Week 49 were included in this group: 1) age: 6 to <16 years; 2)treatment of glucocorticoid steroids >=6 months prior to baseline and continuous use until the latest visit week; 3) 4SC: 2-15.9 seconds; 4) participants who were ambulatory at baseline; 5) LVEF: >=55% or missing.|Baseline, Week 49|This analysis population included all participants randomized in Sequence 3 and received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Error|Least Squares Mean
2588153|NCT02310750|Primary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Heart Rate at Day 28||Baseline, 16 hours post-dose on Day 28|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||bpm||Standard Deviation|Mean
2588379|NCT02308163|Secondary|Change From Baseline in CRP Through Week 52|Higher CRP indicates greater disease activity.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||mg/dL||Standard Deviation|Mean
2588078|NCT02310763|Secondary|Change From Baseline to Week 97 on FVC for Participants in Sequence 1 Compared to the Natural History Control Group|FVC was measured by spirometry to evaluate respiratory muscle function. MMRM was used to analyze the change from baseline on FVC for domagrozumab compared to the natural history control group. The natural history control group was established by filtering the CINRG natural history database. Participants who met the following requirements at baseline and had evaluable FVC data on Week 97 were included in this group: 1) age: 6 to <16 years; 2) treatment of glucocorticoid steroids >=6 months prior to baseline and continuous use until the latest visit week; 3) 4SC: 2-15.9 seconds; 4 participants who were ambulatory at baseline; 5) LVEF: >=55% or missing.|Baseline, Week 97|This analysis population included all participants randomized in Sequence 1 and received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||Liters||Standard Error|Least Squares Mean
2588079|NCT02310763|Secondary|Change From Baseline to Week 49 on FVC for Participants in Sequence 3 Compared to the Natural History Control Group|FVC was measured by spirometry to evaluate respiratory muscle function. MMRM was used to analyze the change from baseline on FVC for the natural history control group compared to placebo group (Sequence 3). MMRM was used to analyze the change from baseline on FVC for the natural history control group compared to placebo group (Sequence 3). This MMRM was established to assess the appropriateness on using the natural history control group as a comparator. The natural history control group was established by filtering the CINRG natural history database. Participants who met the following requirements at baseline and had evaluable FVC data on Week 49 were included in this group: 1) age: 6 to <16 years; 2)treatment of glucocorticoid steroids >=6 months prior to baseline and continuous use until the latest visit week; 3) 4SC: 2-15.9 seconds; 4) participants who were ambulatory at baseline; 5) LVEF: >=55% or missing.|Baseline, Week 49|This analysis population included all participants randomized in Sequence 3 and received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||Liters||Standard Error|Least Squares Mean
2588080|NCT02310763|Secondary|Change From Baseline to Week 97 on 4SC for Participants in Sequence 1 Compared to the Natural History Control Group|The 4SC quantified the time required for a participant to ascend 4 standard steps. MMRM was used to analyze the change from baseline on 4SC for domagrozumab compared to the natural history control group. The natural history control group was established by filtering the CINRG natural history database. Participants who met the following requirements at baseline and had evaluable 4SC data on Week 97 were included in this group: 1) age: 6 to <16 years; 2) treatment of glucocorticoid steroids >=6 months prior to baseline and continuous use until the latest visit week; 3) 4SC: 2-15.9 seconds; 4 participants who were ambulatory at baseline; 5) LVEF: >=55% or missing.|Baseline, Week 97|This analysis population included all participants randomized in Sequence 1 and received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||Seconds||Standard Error|Least Squares Mean
2588081|NCT02310763|Secondary|Change From Baseline to Week 49 on 4SC for Participants in Sequence 3 Compared to the Natural History Control Group|The 4SC quantified the time required for a participant to ascend 4 standard steps. MMRM was used to analyze the change from baseline on 4SC for the natural history control group compared to placebo group (Sequence 3). This MMRM was established to assess the appropriateness on using the natural history control group as a comparator. The natural history control group was established by filtering the CINRG (Cooperative International Neuromuscular Research Group) natural history database. Participants who met the following requirements at baseline and had evaluable 4SC data on Week 49 were included in this group: 1) age: 6 to <16 years; 2)treatment of glucocorticoid steroids >=6 months prior to baseline and continuous use until the latest visit week; 3) 4SC: 2-15.9 seconds; 4) participants who were ambulatory at baseline; 5) LVEF: >=55% or missing.|Baseline, Week 49|This analysis population included all participants randomized in Sequence 3 and received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||Seconds||Standard Error|Least Squares Mean
2588082|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on Muscle Strength of Shoulder Abduction at Weeks 17, 33 and 49|Muscle strength was quantified by means of a handheld dynamometer. The following muscle groups were evaluated: knee extension, elbow flexion, hip abduction, elbow extension and shoulder abduction. MMRM was used to analyze the change from baseline on muscle strength for domagrozumab compared to placebo. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Weeks 17, 33 and 49|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Kilograms||Standard Error|Least Squares Mean
2588083|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on Muscle Strength of Knee Extension at Weeks 17, 33 and 49|Muscle strength was quantified by means of a handheld dynamometer. The following muscle groups were evaluated: knee extension, elbow flexion, hip abduction, elbow extension and shoulder abduction. MMRM was used to analyze the change from baseline on muscle strength for domagrozumab compared to placebo. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Weeks 17, 33 and 49|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Kilograms||Standard Error|Least Squares Mean
2588154|NCT02310750|Primary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10||Baseline, 16 hours post-dose on Day 10|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||bpm||Standard Deviation|Mean
2588155|NCT02310750|Primary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1||Baseline, 24 hours post-dose on Day 1|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.|||bpm||Standard Deviation|Mean
2588084|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on Muscle Strength of Hip Abduction at Weeks 17, 33 and 49|Muscle strength was quantified by means of a handheld dynamometer. The following muscle groups were evaluated: knee extension, elbow flexion, hip abduction, elbow extension and shoulder abduction. MMRM was used to analyze the change from baseline on muscle strength for domagrozumab compared to placebo. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Weeks 17, 33 and 49|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Kilograms||Standard Error|Least Squares Mean
2588085|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on Muscle Strength of Elbow Flexion at Weeks 17, 33 and 49|Muscle strength was quantified by means of a handheld dynamometer. The following muscle groups were evaluated: knee extension, elbow flexion, hip abduction, elbow extension and shoulder abduction. MMRM was used to analyze the change from baseline on muscle strength for domagrozumab compared to placebo. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Weeks 17, 33 and 49|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Kilograms||Standard Error|Least Squares Mean
2588086|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on Muscle Strength of Elbow Extension at Weeks 17, 33 and 49|Muscle strength was quantified by means of a handheld dynamometer. The following muscle groups were evaluated: knee extension, elbow flexion, hip abduction, elbow extension and shoulder abduction. MMRM was used to analyze the change from baseline on muscle strength for domagrozumab compared to placebo. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Weeks 17, 33 and 49|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Kilograms||Standard Error|Least Squares Mean
2588087|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on the Six Minute Walk Distance (6MWD) Score at Weeks 17, 33 and 49|6MWD evaluated ambulation ability by measuring the distance walked in 6 minutes. MMRM was used to analyze the change from baseline on 6MWD for domagrozumab compared to placebo. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Weeks 17, 33 and 49|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of timepoints.|||Meters||Standard Error|Least Squares Mean
2588088|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on the Performance of Upper Limb (PUL) Overall Score at Weeks 17, 33 and 49|The PUL was used to assess motor performance of the upper limb. The PUL scale includes 22 items; an entry item defining the starting functional level, and 21 items subdivided into three levels: shoulder (4 items), middle (9 items) and distal (8 items). Scoring options per item may not be uniform and may vary from 0-1 and 0-6, according to the performance, with higher values corresponding to better performance. A total maximum score of 74 is achieved by adding the individual level scores. MMRM was used to analyze the change from baseline for domagrozumab compared to placebo. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Weeks 17, 33 and 49|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of timepoints.|||Units on a scale||Standard Error|Least Squares Mean
2588089|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on the Ankle Range of Motion (ROM) at Weeks 17, 33 and 49|ROM was evaluated by using goniometry to evaluate the loss of motion in the ankles. MMRM was used to analyze the change from baseline on ROM for domagrozumab compared to placebo. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Weeks 17, 33 and 49|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Degrees of passive dorsiflexion||Standard Error|Least Squares Mean
2588099|NCT02310763|Primary|Summary of Tanner Stage Rating by Week 49|Tanner staging was performed before the first dose of each dose escalation to monitor for signs of accelerated sexual development. The physical changes in pubertal development (pubic hair, penis and testes) were assessed using the system described by Marshall and Tanner. Stage 1 is preadolescent, Stages 2, 3, and 4 are initiation of puberty and Stage 5 is mature adult. Details about the system can be referred to Tanner JM. Growth at Adolescence. Blackwell Scientific Publications 1962; 2nd edition.|Baseline, Weeks 17, 33 and 49|This analysis population included all participants who received at least 1 dose of investigational drug. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Participants|||Count of Participants
2588090|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on the Northstar Ambulatory Assessment (NSAA) at Weeks 17, 33 and 49|The NSAA is a 17-item test that measured gross motor function. Each individual item received a score of 0-unable to perform independently, 1-able to perform with assistance, or 2-able to perform without assistance. A total score was achieved by summing all the individual items. The total score could range from 0 to 34 (fully-independent function). MMRM was used to analyze the change from baseline for domagrozumab compared to placebo. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Weeks 17, 33 and 49|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of timepoints.|||Units on a scale||Standard Error|Least Squares Mean
2588091|NCT02310763|Secondary|Change From Baseline as Compared to Placebo on Forced Vital Capacity (FVC) at Weeks 17, 33 and 49|FVC was measured by spirometry to evaluate respiratory muscle function. MMRM was used to analyze the change from baseline on FVC for domagrozumab compared to placebo. The stratification factor, baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Weeks 17, 33 and 49|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of timepoints.|||Liters||Standard Error|Least Squares Mean
2588092|NCT02310763|Primary|Change From Baseline on the 4 Stair Climb (4SC) as Compared to Placebo at Weeks 17, 33 and 49|The 4SC quantified the time required for a participant to ascend 4 standard steps. Mixed effect model for repeated measures (MMRM) was used to analyze the change from baseline on 4SC for domagrozumab compared to placebo. The baseline result, treatment, time and treatment by time interaction were included as fixed effects in the model. Participants were included as a random effect and the model was fit with an unstructured covariance for the repeated measures.|Baseline, Weeks 17, 33 and 49|This analysis population included all participants randomized and who had received at least 1 dose of randomized treatment. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of timeponts.|||Seconds||Standard Error|Least Squares Mean
2588093|NCT02310763|Primary|Number of Participants With Suicidal Ideation and Suicidal Behavior Reported as AEs by Week 49|An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. The Columbia Suicide Severity Rating Scale (C-SSRS) was performed to identify the risk of suicide ideation or behavior. AEs of suicide ideation or behavior were determined by the investigator.|Baseline to Week 49 visit|This analysis population included all participants who received at least 1 dose of investigational drug. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2588094|NCT02310763|Primary|Bone Age to Chronological Age Ratio by Week 49|Bone age assessment was evaluated by the ratio of the bone age to the chronological age using the X rays of the hand and wrist. Ratio of bone age to chronological age was calculated by bone age/chronological age at scan date. Chronological age at scan date was calculated by (scan date-date of birth+1)/365.25.|Screening, Weeks 17, 33 and 49|This analysis population included all participants who received at least 1 dose of investigational drug. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of timepoints.|||Ratio||Standard Deviation|Mean
2588095|NCT02310763|Primary|Height-adjusted Z-score of Lumbar Spine Bone Mineral Density Over Time by Week 49|"Bone mineral density (BMD) was evaluated by Dual energy X-ray Absorptiometry (DXA). The height adjusted Z-score presented below is the number of standard deviations which compares the BMD of the participant to the average BMD matched for their age, sex and ethnicity. If the Z-score was -2 standard deviations or lower, the result was below the expected range for age. If the Z-score was above -2 standard deviations, the result was within the expected range for age."|Screening and Week 49|This analysis population included all participants who received at least 1 dose of investigational drug. Number analyzed refers to number of participants evaluable for specified rows of timepoints.|||Standard deviations||Standard Deviation|Mean
2588096|NCT02310763|Primary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Compared to Placebo by Week 49|The LVEF was the ratio of blood ejected during systole to blood in the ventricle at the end of diastole. LVEF was measured by cardiac magnetic resonance image (MRI) or echocardiogram. The same method of cardiac imaging was used consistently within a single participant. Cardiac MRIs were read by a central imaging vendor and echocardiograms were read locally at each site. The LVEF values measured by cardiac MRI and echocardiogram are combined in the following presentation. The analysis of covariance (ANCOVA) model was used to analyze the change from baseline for domagrozumab compared to placebo on LVEF. The baseline result, age, use of angiotensin receptor blocker (ARB)/beta blocker/angiotensin converting enzyme (ACE) inhibitor and treatment were included as fixed effects in the model.|Baseline to Week 49 visit|This analysis population included all participants who received at least 1 dose of investigational drug. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||Ratio of blood||Standard Error|Least Squares Mean
2588097|NCT02310763|Primary|Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria by Week 49|Number of participants with ECG data meeting the following criteria are presented: 1) corrected QT interval using Fridericia's formula (QTcF interval) <450msec; 2) QTcF interval >=450 and <480msec; 3) QTcF interval >=480 and <500msec; 4) QTcF interval>=500msec; 5) QTcF interval increase from baseline<30msec; 6) QTcF interval increase from baseline >=30 and <60msec; 7) QTcF interval increase from baseline >=60msec.|Baseline to Week 49 visit|This analysis population included all participants who received at least 1 dose of investigational drug. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2588100|NCT02310763|Primary|Number of Participants With Physical Examination Findings Reported as SAEs by Week 49|Physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. A targeted nose and throat mucosal exam were also performed to monitor for any signs of mucosal telangiectasias. An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Investigators determined which physical examination findings were reported as SAEs.|Baseline to Week 49 visit|This analysis population included all participants who received at least 1 dose of investigational drug.|||Participants|||Count of Participants
2588101|NCT02310763|Primary|Categorical Summary of Liver Iron Accumulation by Week 49|Magnetic resonance imaging (MRI) of Liver was obtained to quantify liver iron accumulation for safety monitoring. MRIs were sent to an independent central radiology imaging facility for calculation of the average transverse relaxation rate (R2*) value which was used to monitor for iron accumulation in the liver. Number of participants meeting the following criteria is presented as follows: 1) normal: R2*<=75Hz at 1.5T or <=139 Hz at 3.0T; 2) above normal: R2*>75Hz and <=190Hz at 1.5T or R2* >139Hz and <=369Hz at 3.0T; 3) mild overload: R2*>190Hz at 1.5T or R2*>360Hz at 3.0T.|Screening, Weeks 13, 29 and 45|This analysis population included all participants who received at least 1 dose of investigational drug. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Participants|||Count of Participants
2588102|NCT02310763|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) by Week 49 - Fecal|Number of participants with blood detected in fecal samples is presented.|Baseline to Week 49 visit|This analysis population included all participants who received at least 1 dose of investigational drug and had at least 1 fecal evaluation.|||Participants|||Count of Participants
2588103|NCT02310763|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) by Week 49 - Urinalysis|Urinalysis included: urine pH, qualitative urine glucose, qualitative urine ketones, qualitative urine protein, qualitative blood/hemoglobin, urine nitrite, urine leukocytes, urine RBC, urine WBC, urine granular casts, urine hyaline casts, urine urate (uric acid) acidic crystal, urine calcium oxalate crystals, urine amorphous crystals, urine bacteria, urine microscopic exam.|Baseline to Week 49 visit|This analysis population included all participants who received at least 1 dose of investigational drug. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Participants|||Count of Participants
2588104|NCT02310763|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) by Week 49 - Clinical Chemistry|Clinical chemistry evaluation included glucose, creatine kinase (CK), troponin I, and amylase.|Baseline to Week 49 visit|This analysis population included all participants who received at least 1 dose of investigational drug. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Participants|||Count of Participants
2588105|NCT02310763|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) by Week 49 - Hormones|Hormone evaluations included free thyroxine (T4), thyroid stimulating hormone (TSH), lutenizing hormone (LH), follicle stimulating hormone (FSH), and androstenedione. Numbers of participants with abnormalities of LH, FSH and androstenedione were reported in different age groups.|Baseline to Week 49 visit|This analysis population included all participants who received at least 1 dose of investigational drug. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Participants|||Count of Participants
2588106|NCT02310763|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) by Week 49 - Electrolytes|Electrolytes evaluation included: sodium, potassium, chloride, calcium, phosphate, bicarbonate, ferritin, transferrin saturation, iron, iron binding capacity and unsaturated iron binding capacity. Number of participants with iron abnormalities was reported in different age groups.|Baseline to Week 49 visit|This analysis population included all participants who received at least 1 dose of investigational drug. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Participants|||Count of Participants
2588107|NCT02310763|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) by Week 49 - Renal Function|Renal function evaluation included: blood urea nitrogen (BUN), creatinine and uric acid.|Baseline to Week 49 visit|This analysis population included all participants who received at least 1 dose of investigational drug. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2588108|NCT02310763|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) by Week 49 - Liver Function|Liver function evaluation included: total/direct/indirect bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase, total protein, albumin and glutamate dehydrogenase.|Baseline to Week 49 visit|This analysis population included all participants who received at least 1 dose of investigational drug. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Participants|||Count of Participants
2588109|NCT02310763|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) by Week 49 - Coagulation|Coagulation evaluation included activated partial thromboplastin time (aPTT) and prothrombin time (PT).|Baseline to Week 49 visit|This analysis population included all participants who received at least 1 dose of investigational drug. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2588289|NCT02308696|Secondary|Social Support as Assessed by the 8-item Medical Outcomes Study Social Support Survey|Investigators will use the 8-item medical outcomes study social support survey to measure social support. Scored from 1-5, and a score of 1 indicates lower levels of social support while a score of 5 indicates higher levels of social support.|1 year||||units on a scale||95% Confidence Interval|Mean
2588110|NCT02310763|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) by Week 49 - Hematology|Hematology evaluation included: hemoglobin, hematocrit, red blood cell (RBC) count, platelets, RBC morphology, white blood cell (WBC) count, absolute lymphocytes, absolute atypical lymphocytes, absolute total neutrophils, absolute total neutrophils count, absolute band cells, absolute basophils, absolute eosinophils, absolute monocytes and absolute myelocytes.|Baseline to Week 49 visit|This analysis population included all participants who received at least 1 dose of investigational drug. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Participants|||Count of Participants
2588111|NCT02310763|Primary|Number of Participants With Dose Reduced or Temporary Discontinuation Due to TEAEs by Week 49|An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.|Study Day 1 to Week 49 visit|The analysis population included all participants who received at least 1 dose of investigational drug. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2588112|NCT02310763|Primary|Number of Participants Who Discontinued From the Study Due to TEAEs by Week 49|An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.|Study Day 1 to Week 49 visit|The analysis population included all participants who received at least 1 dose of investigational drug. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2588113|NCT02310763|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) by Week 49|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and AEs. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Severe TEAEs were TEAEs that interfered significantly with participants' usual function. Treatment-related TEAEs were determined by the investigator.|Study Day 1 to Week 49 visit|The analysis population included all participants who received at least 1 dose of investigational drug. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2588114|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56||Baseline, Day 4, 6 ,8,10, 13, 14, 21, 28, 35, 42, 56|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||cells/mm^3||Standard Deviation|Mean
2588115|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28||Baseline, Day 4, 8, 10, 11, 14, 28|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||cells/mm^3||Standard Deviation|Mean
2588116|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8||Baseline, Day 2, 5, 8|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||cells/mm^3||Standard Deviation|Mean
2588117|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56||Baseline, Day 4, 6 ,8,10, 13, 14, 21, 28, 35, 42, 56|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||cells/mm^3||Standard Deviation|Mean
2588118|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28||Baseline, Day 4, 8, 10, 11, 14, 28|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||cells/mm^3||Standard Deviation|Mean
2588119|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8||Baseline, Day 2, 5, 8|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||cells per millimeter cube (cells/mm^3)||Standard Deviation|Mean
2588120|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56|Serum samples for hsCRP were analyzed using a validated analytical assay. Reference range for measurement of CRP was 0.015 to 2.0 mg/dL. LLOQ for hsCRP was 0.03 mg/dL and limit of detection was 0.015 mg/dL.|Baseline, Day 2, 5 ,7,14, 21, 28, 29, 35, 56|PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2588156|NCT02310750|Primary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28||Baseline, 16 hours post-dose on Day 28|FAS included all participants who received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||msec||Standard Deviation|Mean
2588126|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Renal Clearance|Renal clearance was calculated as amount of drug recovered unchanged in urine during the dosing interval tau (Aetau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort.|0-24 hours on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.|||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
2588127|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Percentage of Dose of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau%)|Aetau% was calculated as: 100*Aetau/dose. Aetau is the amount of drug recovered unchanged in urine during the dosing interval (tau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort.|0-24 hours on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.|||percentage of dose recovered||Geometric Coefficient of Variation|Geometric Mean
2588128|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Amount of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau)|Aetau is the amount of drug recovered unchanged in urine during the dosing interval (tau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort.|0-24 hour on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.|||milligram||Geometric Coefficient of Variation|Geometric Mean
2588129|NCT02310750|Secondary|Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Peak-Trough Fluctuation (PTF) of PF-06700841|PTF was calculated as: Cmax-Cmin/Cavg. Cmax is the maximum observed plasma concentration of PF-06700841. Cmin is the minimum observed plasma concentration of PF-06700841. Cavg is the average observed plasma concentration of PF-06700841 calculated as area under the plasma concentration-time curve during a dosing Interval (AUC[tau]) divided by the dosing interval (tau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort and 24 hours for MAD Psoriasis cohort.|MAD: pre--dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post--dose on Day 10; MAD Psoriasis: pre--dose, 0.5,1,2,4,6,8,12,16,24 hours post-dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: MAD Cohort, MAD Psoriasis Cohort arm.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2588130|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) of PF-06700841|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Clearance obtained after oral dose is influenced by the fraction of the dose absorbed. CL/F =Dose of PF-06700841/AUCinf.|SAD: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post-dose on Day 1; MAD: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.|||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2588131|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) of PF-06700841|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|SAD: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post-dose on Day 1; MAD: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.|||liter||Standard Deviation|Mean
2588132|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) of PF-06700841|MRT= AUMCinf/AUCinf, where AUMCinf is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method.|SAD: pre--dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post-dose on Day 1; MAD: pre--dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post--dose on Day 10; MAD Psoriasis: pre--dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.|||hour||Geometric Coefficient of Variation|Geometric Mean
2588133|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841|Plasma decay half-life is the time measured for the plasma concentration of PF-06700841 to decrease by one half.|SAD: pre--dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post-dose on Day 1; MAD: pre--dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre--dose, 0.5,1,2,4,6,8,12,16,24 hours post-dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.|||hour||Standard Deviation|Mean
2588901|NCT02299869|Primary|Comfort|Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).|20 minutes||||units on a scale||Standard Deviation|Mean
2588134|NCT02310750|Secondary|Multiple Ascending Dose (MAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau[dn]) of PF-06700841|Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort. AUCtau(dn) was calculated by dividing AUCtau by the exact dose of of PF-06700841 (in mg) administered to a participant.|pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.|||[ng*hr/mL]/mg||Geometric Coefficient of Variation|Geometric Mean
2588135|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of PF-06700841|Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast). AUClast(dn) was calculated by dividing AUClast by the exact dose of of PF-06700841 (in mg) administered to a participant.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm.|||[ng*hr/mL]/mg||Geometric Coefficient of Variation|Geometric Mean
2588136|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf[dn]) of PF-06700841|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUCinf(dn) was calculated by dividing AUCinf by the exact dose of PF-06700841 (in mg) administered to a participant.|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm.|||[nanogram*hour/milliliter]/milligram||Geometric Coefficient of Variation|Geometric Mean
2588137|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06700841|Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of PF 06700841 (in mg) administered to a participant.|SAD: pre-dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post dose on Day 1; MAD: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.|||[nanogram/milliliter]/milligram||Geometric Coefficient of Variation|Geometric Mean
2588138|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841|Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast).|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2588139|NCT02310750|Secondary|Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06700841|Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort and 24 hours for MAD Psoriasis cohort.|MAD: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: MAD Cohort, MAD Psoriasis Cohort arm|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2588140|NCT02310750|Secondary|Single Ascending Dose (SAD) Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2588141|NCT02310750|Secondary|Food Effect Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF--06700841||Pre--dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest.|||hour||Full Range|Median
2588142|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841||SAD: pre-dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post dose on Day 1; MAD: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm|||hour||Full Range|Median
2588157|NCT02310750|Primary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10||Baseline, 16 hours post-dose on Day 10|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||msec||Standard Deviation|Mean
2588143|NCT02310750|Secondary|Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841||SAD: pre-dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post dose on Day 1; MAD: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, ‘N’ signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2588144|NCT02310750|Primary|Food Effect Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841||pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2588145|NCT02310750|Primary|Food Effect Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841|Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast).|pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2588146|NCT02310750|Primary|Food Effect Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).|Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1|PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2588147|NCT02310750|Primary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 28|Creatinine clearance is a measure of kidney function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time.|Baseline, 16 hours post-dose on Day 28|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘N’ signifies those participants who were evaluable for this outcome measure.|||mL/min||Standard Deviation|Mean
2588148|NCT02310750|Primary|Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10|Creatinine clearance is a measure of kidney function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time.|Baseline, 16 hours post-dose on Day 10|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mL/min||Standard Deviation|Mean
2588149|NCT02310750|Primary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1|Creatinine clearance is a measure of kidney function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time.|Baseline, 24 hours post-dose on Day 1|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||milliliter per minute (mL/min)||Standard Deviation|Mean
2588150|NCT02310750|Primary|Number of Participants With Laboratory Abnormalities|Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count: less than(<) 0.8*lower limit of normal (LLN); mean corpuscular volume; mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration: <0.9*LLN,>1.1*upper limit of normal (ULN); platelets: <0.5*LLN,>1.75*ULN, white blood cell count: <0.6*LLN, >1.5*ULN; lymphocytes, total neutrophils: <0.8*LLN, >1.2*ULN; eosinophils, basophils, monocytes: >1.2*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: >1.1*ULN; liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN)|SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.|||participants|||Number
2588151|NCT02310750|Primary|Number of Adverse Events (AEs) According to Severity|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.|SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.|||adverse events|||Number
2588152|NCT02310750|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug up to the end of study (up to Day 8 in SAD cohort, Day 28 in MAD cohort, Day 56 in MAD Psoriasis cohort, Day 37 in Food effect cohort), that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE.|SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.|||participants|||Number
2588159|NCT02310750|Primary|Number of Participants With Change From Baseline in Physical Examinations|Physical examinations included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems.|SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.|||participants|||Number
2588160|NCT02310750|Primary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Oral Temperature at Day 28||Baseline, 16 hours post-dose on Day 28|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||degrees celsius||Standard Deviation|Mean
2588161|NCT02310750|Primary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10||Baseline, 16 hours post-dose on Day 10|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||degree celsius||Standard Deviation|Mean
2588162|NCT02310750|Primary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1||Baseline, 24 hours post-dose on Day 1|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.|||degree celsius||Standard Deviation|Mean
2588163|NCT02310750|Primary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Pulse Rate at Day 28||Baseline, 16 hours post-dose on Day 28|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||bpm||Standard Deviation|Mean
2588164|NCT02310750|Primary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10||Baseline, 16 hours post-dose on Day 10|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||bpm||Standard Deviation|Mean
2588165|NCT02310750|Primary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1||Baseline, 24 hours post-dose on Day 1|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.|||beats per minute (bpm)||Standard Deviation|Mean
2588166|NCT02310750|Primary|Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28||Baseline, 16 hours post-dose on Day 28|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mmHg||Standard Deviation|Mean
2588167|NCT02310750|Primary|Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10||Baseline, 16 hours post-dose on Day 10|FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||mmHg||Standard Deviation|Mean
2588168|NCT02310750|Primary|Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1||Baseline, 24 hours post-dose on Day 1|Full analysis set (FAS) included all participants who were randomized to treatment and received at least 1 dose of study medication.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2588169|NCT02310646|Other Pre-specified|Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2|Comparison of contribution of each product attribute in the stated preference between trial treatments (foam and gel)|Baseline to Week 2|In total 103 preferred foam and 105 preferred gel. 4 subjects ...|||percentage of subjects|||Number
2588170|NCT02310646|Other Pre-specified|Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments|The VPM questionnaire was analysed the same way as the TPUQ. Numeric scores were calculated by assigning the following values to each response category: -3 = Extremely unappealing, -2 = Moderately unappealing, -1 = Slightly unappealing, 0 = Neutral, 1 = Slightly appealing, 2 = Moderately appealing, 3 = Extremely appealing. A summary score was defined as the sum of all questions and could range from -21 to 21.|At Week 1 and Week 2||||units on a scale||Standard Deviation|Mean
2588171|NCT02310646|Other Pre-specified|Responses to Comparison to Last Topical Treatment Questionnaire (CLTT) for Each of the Two Trial Treatments (Foam or Gel)|"Subjects in both arms (foam-gel; gel-foam) indicated whether they preferred latest topical treatment, LEO 90100 aerosol foam, Daivobet® gel, or did not have any preference.~The subjects compared the trial treatment used the previous week with the latest topical treatment (used within 3 months prior to baseline; CLTT analysis set). Each item was scored with either 'prefer latest treatment', 'no preference', or 'prefer trial medication (foam or gel)'. A subject could prefer both study treatments over the latest topical treatment. The percentage is given for the number of subjects preferring foam and number of subjects preferring gel."|At Week 1 and Week 2|CLTT analysis set was defined by including all randomised subjects who had used topical anti-psoriatic medication on the treatment area (trunk and/or limbs) within 3 months prior to Baseline.|||percentage of subjects|||Number
2588172|NCT02310646|Other Pre-specified|Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments|"The TPUQ tool was used to evaluate the subject's latest topical treatment at Baseline (used within 3 months prior to baseline). TPUQ assessments of trial treatments at Week 1 and Week 2.~Each response category (item 1 to 25) was assigned a numeric score from-2=strongly disagree to 2=strongly agree. For item 26 the assigned scores were from -2=very dissatisfied to 2=very satisfied.~Summary scores were calculated by summing numeric scores for items under each domain, i.e., application (items 1-9; score range -18 to +18), formulation (items 10-18; score range -18 to +18), container (items 19-22; score range -8 to +8), and satisfaction (items 23-25; score range -6 to +6).~For each subject and each item, the latest topical treatment score was compared with each study treatment by calculating the difference between the scores, i.e., by subtracting the latest topical treatment score from each study medication score. The higher score signifies higher preference in that domain."|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
2588902|NCT02299869|Primary|Comfort|Participant's subjective rating for comfort. (Scale 0-10, 0=poor, 10=excellent).|Baseline||||units on a scale||Standard Deviation|Mean
2588173|NCT02310646|Other Pre-specified|Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments|"Each response category (item 1 to 25) was assigned a numeric score (-2=strongly disagree, -1=slightly disagree, 0=neither agree nor disagree, 1=slightly agree, 2=strongly agree). For item 26, the assigned score were from -2=very dissatisfied to 2=very satisfied.~Summary scores were calculated by summing numeric scores for items under each domain, i.e., application (items 1-9; score range -18 to +18), formulation (items 10-18; score range -18 to +18), container (items 19-22; score range -8 to +8), and satisfaction (items 23-25; score range -6 to +6). Positive scores indicate agreement with domains' items.~A total TPUQ summary score (item 1-25; score range -50 to +50) was also calculated. The summary scores were analysed in the same way as the individual questions. The higher score signifies higher preference in that domain."|2 weeks||||units on a scale||Standard Deviation|Mean
2588174|NCT02310646|Primary|Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics|"The SPA questionnaire was completed at Week 2 and consisted of 2 parts:~(i) the subject indicated if they preferred LEO 90100 foam or Daivobet® gel based on their experience using these products for 1 week each during the 2-weeks treatment period; (ii) the subject indicated how much each of the 22 items under the application, formulation, and container domains contributed to their overall decision of which product they preferred. This part of the SPA tool used a 4-point scale ranging from 'very important factor' to 'not at all important factor'.~The statistical significance of each of the following 7 baseline characteristics (gender, age, disease severity, distribution, plaque size, skin thickness, onset) was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors.~Results of multiple regression analyses are provided in the Clinical Study Report which can be found on the LEO Pharma website."|2 weeks||||percentage of subjects|||Number
2588175|NCT02310581|Secondary|Percentage of Participants Who Used Rescue Medication for Pain|The percentage of participants who needed to take an alternate medication for pain relief during the study.|From Time 0 (first dose of study drug) up to Day 9|ITT Population included all participants who were randomized.|||percentage of participants|||Number
2588176|NCT02310581|Secondary|NRS SPID Over 0 to 24 Hours After Time 0 (NRS SPID-24)|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 24 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-24 range is -240 to 240. The NRS SPID-24 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.|Baseline and 0 to 24 hours after Time 0|ITT Population included all participants who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2588177|NCT02310581|Secondary|NRS SPID Over 0 to 8 Hours After Time 0 (NRS SPID-8)|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 8 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-8 range is -80 to 80. The NRS SPID-8 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.|Baseline and 0 to 8 hours after Time 0|ITT Population included all randomized participants.|||units on a scale||Standard Error|Least Squares Mean
2588178|NCT02310581|Secondary|NRS SPID Over 0 to 4 Hours After Time 0 (NRS SPID-4)|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 4 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-4 range is -40 to 40. The NRS SPID-4 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.|Baseline and 0 to 4 hours after Time 0|ITT Population included all participants who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2588179|NCT02310581|Secondary|NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain.|4, 8, 24 and 48 hours after Time 0|All randomized participants from the ITT Population with data available at each timepoint.|||units on a scale||Standard Deviation|Mean
2588180|NCT02310581|Secondary|NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). NRS PID is defined as the difference in pain at each scheduled timepoint relative to Baseline (PID=pain intensity at baseline - pain intensity at time point). A higher value of NRS PID score indicates a higher decrease in pain from Baseline.|Baseline and 4, 8, 24 and 48 hours after Time 0|All randomized participants from the ITT Population with data available at each timepoint.|||units on a scale||Standard Deviation|Mean
2588181|NCT02310581|Primary|Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48)|Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain [maximum (max)=10 at each time point] and negative numbers indicate an increase in pain [minimum (min)=-10 at each time point]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.|Baseline and 0 to 48 hours after Time 0|All randomized participants from the Intent-to-Treat (ITT) Population.|||units on a scale||Standard Error|Least Squares Mean
2588182|NCT02310568|Secondary|Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores|Percentage of participants with HAM-A total score less than or equal to 7 in the last week of the Stage (Week 4 in Stage 1, Week 8 in Stage 2). The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Stage 1: Week 1 up to Week 4 and Stage 2: Week 5 up to Week 8|Full analysis set for Stage 1 was defined as all participants randomized and who had received at least 1 dose of randomized treatment. The Stage 2 placebo non-responder set was defined as the subset of subjects in the Stage 2 placebo set who had both a <50% reduction in HAM-A between Stage 1 baseline and Week 4, and HAM-A value of >= 16 at Week 4.|||percentage of participants|||Number
2588183|NCT02310568|Secondary|Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8|The HAM-A scale was a clinician interview-administered scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Somatic subscale of the HAM-A was the sum of 7 items. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 28 (very severe), where lower scores indicates less anxiety.|Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2588184|NCT02310568|Secondary|Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8|The HAM-A scale was a clinician interview-administered scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Psychic subscale of the HAM-A was the sum of 7 items. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 28 (very severe), where lower scores indicates less anxiety.|Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2588185|NCT02310568|Secondary|Plasma Concentration Versus Time Summary of PF-06372865: Stage 2|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.|Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 6, 7, 8|Placebo Non-Responder set for Stage 2. Participants who received PF-06372865 2.5 mg or PF-06372865 7.5 mg were evaluable for this measure. Here,‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||ng/mL||Standard Deviation|Mean
2588186|NCT02310568|Secondary|Plasma Concentration Versus Time Summary of PF-06372865: Stage 1|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 nanogram per milliliter (ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.|Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 2, 3, 4|Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Participants who received PF-06372865 2.5 mg or PF-06372865 7.5 mg were evaluable for this measure. Here,‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||ng/mL||Standard Deviation|Mean
2588187|NCT02310568|Secondary|Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2|"The CGI-S consisted of a single 7-point rating score of illness severity, was completed by a clinician. Raters selected one response based on the following question, Considering your total clinical experience with that particular population, how mentally ill was your participant at that time? Scores were: 1 (normal, not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill) 6 (severely ill) or 7 (among the most severely ill participants). Higher scores indicate more severity."|Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2588206|NCT02309489|Secondary|Number of Participants With an Unmet Need for Contraception at 8 Months Postpartum|Unmet need for contraception is a concept used to describe the situation in which women are at risk of conceiving, yet do not wish to become pregnant. Several definitions of unmet need for contraception have been proposed. The Revised definition of unmet need published by the DHS Program in 2012 was chosen. This definition classifies women as either having an unmet need, or not, based on the interaction of several criteria: whether or not they wanted the index pregnancy; whether or not their periods have returned after giving birth; whether or not they want to become pregnant again, and if so how soon.|Data collected at 8 months postpartum||||Participants|||Count of Participants
2588188|NCT02310568|Secondary|Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2|CGI-I was a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score indicated more affected. Change is equal to score at observation minus score at baseline.|Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2588189|NCT02310568|Secondary|Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2|A responder was defined as a participant with >= to 50 percent decrease in their total HAM-A score from baseline to the last week in the stage (Week 4 in Stage 1, Week 8 in Stage 2). The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety. Percentage of responders of total HMA scale were reported.|Stage 1: Week 4, Stage 2: Week 8|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2588190|NCT02310568|Secondary|Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Week 1, 2, 3|Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Error|Least Squares Mean
2588191|NCT02310568|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2|SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment.|Stage 1: Week 4, Stage 2: Week 8|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Error|Least Squares Mean
2588192|NCT02310568|Secondary|Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2|SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment.|Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2588193|NCT02310568|Secondary|Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Week 5, 6, 7, 8|Stage 2 placebo non-responder set: Subset of Stage 2 placebo set (participants who received placebo in Stage 1) < 50 % reduction in HAM-A during Stage 1 baseline, Week 4 and HAM-A value of >=16 at Week 4. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Error|Least Squares Mean
2588194|NCT02310568|Primary|Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Stage 1: Week 4, Stage 2: Week 8|Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2588195|NCT02310568|Primary|Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4: Stage 1|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Week 4|Full analysis set for Stage 1 included all randomized participants who had received at least 1 dose of randomized treatment. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2588290|NCT02308696|Secondary|Resilience as Assessed by the Brief Resilience Scale|Investigators will use the Brief Resilience Scale to measure the ability of individuals to bounce back from stress. Six item scale scored from 1-5, with a score of 1 indicating low resilience and a score of 5 indicating high resilience.|1 year||||units on a scale||95% Confidence Interval|Mean
2588903|NCT02299869|Primary|Cosmetic Appearance Preference|Participant's subjective preference for cosmetic appearance. 3 point Likert Scale. 1=prefer CVI-test lens 2=prefer Competitor-control lens, 3=no preference|20 minutes||||participants|||Number
2588196|NCT02310568|Primary|Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2|The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.|Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)|Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Stage 2 placebo non-responder set: Subset of Stage 2 placebo set (participants who received placebo in Stage 1) with less than (<) 50% reduction in HAM-A during Stage 1 baseline,Week 4 and HAM-A value of greater than or equal to (>=)16 at Week 4.|||units on a scale||Standard Deviation|Mean
2588197|NCT02310126|Primary|Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire.|CLUE Overall Lens Handling is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).|15 minutes post Contact Lens Insertion|The analysis population consist of subjects that completed all study visits without a major protocol deviation. The analysis was conducted for each lens and strata.|||units on a scale||Standard Deviation|Mean
2588198|NCT02310100|Primary|Number of Participants Experiencing a Device or Procedure-related Serious Adverse Event|The rate of device or procedure serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, compared to a stated performance goal.|7 days|The analysis population includes all subjects in whom a study device was introduced.|||Participants|||Count of Participants
2588199|NCT02310100|Primary|Number of Participants Free From Recurrent, Symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT)|Rate of subjects free from symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3 month blanking period compared to a stated performance goal. Procedural failure defined by any of the following events: (1) Documented recurrence of AF/AFL/AT during the 9-month observational period lasting longer than 30 seconds; (2) Repeat ablation following the blanking period; or (3) Use of s new anti-arrhythmic drug for the documented symptomatic atrial arrhythmia following the blanking period.|12 Months post ablation|Subjects who terminated the study prematurely before experiencing a treatment failure were not considered a treatment success at 12-months. Subjects who terminated the study for reasons clearly unrelated to the study device were also excluded and not considered treatment failures.|||Participants|||Count of Participants
2588200|NCT02309723|Primary|Likelihood of Recommending That Spouse Take Various Cognitive Deficit Disease Management Measures|Proportion of respondents who recommend that the patient's spouse take actions that would be appropriate if the patient has Alzheimer's disease, including: (1) discussion of advance care planning, (2) monitoring of patient's finances, (3) assessment of how compatible the patient's job is with his conditions, (4) the initiation of precautions to ensure the patient is properly taking his medications to manage hypertension and hyperlipidemia.|Online Survey - completion during the estimated 2-3 month field period||||participants|||Number
2588201|NCT02309723|Primary|Likelihood of Recommending a Medication Indicated for Alzheimer's Disease|Proportion of respondents who recommend a medication indicated for the treatment of Alzheimer's Disease, including Acetylcholinesterase inhibitors, N-methyl-D-aspartate receptor antagonists, Typical antipsychotics - e.g., Chlorpromazine (Thorazine), Haloperidol (Haldol), Atypical antipsychotics - e.g., Clozapine (Clozaril), Risperidone (Risperdal), Antidepressant - e.g., Citalopram (Celexa), Venlafaxine (Effexor), Antianxiety agent - e.g. Benzodiazepines, Buspirone (Buspar).|Online Survey - completion during the estimated 2-3 month field period||||participants|||Number
2588202|NCT02309723|Primary|Influence of the Neuroimaging Test on a Finding of Alzheimer's Disease as the Underlying Cause of the Mild Memory Loss|Proportion of respondents who identify Alzheimer's Disease as the sole or a contributing factor that is responsible for the patient's cognitive complaint.|Online Survey - completion during the estimated 2-3 month field period||||participants|||Number
2588203|NCT02309489|Other Pre-specified|Number of Participants in the Intervention Group With High Adherence to the Intervention|High adherence to the intervention was defined as attendance (by the couple or the partner) at at least two out of three intervention components.|Process data collected throughout intervention implementation||||Participants|||Count of Participants
2588204|NCT02309489|Other Pre-specified|Number of Participants With Complete Satisfaction With Care|A tailored satisfaction score was developed to assess participant's satisfaction with routine maternity care received. Questions were adapted from the K4 Health's Respectful Maternity Care toolkit, and from the UK's Care Quality Commission (CQC)'s 2013 Maternity Services Survey. If participants reported having experienced the maximum score for each dimension of satisfaction, they were classed as having complete satisfaction with care.|Data collected at 3 months postpartum||||Participants|||Count of Participants
2588205|NCT02309489|Secondary|Number of Participants With High Relationship Adjustment at 8 Months Postpartum|Relationship adjustment, as defined in this study, was a score calculated based on questions related to: woman's self-reported satisfaction with the relationship; her level of communication and agreement with her male partner on issues related to reproductive health; and who in the household made decisions related to reproductive health and any relevant expenditures. The questions used were derived from similar survey measures (Spanier's Dyadic Adjustment Scale and the Locke-Wallace Marital Adjustment Test (LWMAT)). The median score was chosen as a cut-off point, above which women were considered to have high relationship adjustment, and below which they were considered to have low relationship adjustment.|Data collected at 8 months postpartum||||Participants|||Count of Participants
2588291|NCT02308696|Secondary|Self-Efficacy as Assessed by the General Self-efficacy Scale to Measure an Individual's Sense of Perceived Self-efficacy.|Investigators will use the General Self-efficacy Scale to measure an individual's sense of perceived self-efficacy. The total score ranges between 1 and 4, with 1 indicating low self-efficacy and 4 indicating high self-efficacy.|1 year||||units on a scale||95% Confidence Interval|Mean
2605732|NCT02107014|Primary|Change in MCP-3 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2588207|NCT02309489|Secondary|Number of Participants Who Initiated Postpartum Contraception in a Timely Fashion|"Whether or not users of modern contraception at 8 months postpartum had initiated their method in a timely fashion was assessed. This was a binary outcome with users of effective methods as the denominator. Users were considered to have initiated contraception either in a timely fashion, or not in a timely fashion. Timeliness in this context refers to whether women had been exposed to a significant risk of becoming pregnant prior to initiating their contraceptive method.~Specifically, whether or not women using contraception had initiated it in a timely fashion (timeliness) was defined based on the interaction between four criteria: when they initiated the method (either in the first 6 months postpartum or later); whether they had reported to be exclusively breastfeeding at 3 months postpartum (yes or no); whether at that point in time they had resumed intercourse (yes or no); and whether at that point their menses had returned (yes or no)."|Data collected at 8 months postpartum||||Participants|||Count of Participants
2588208|NCT02309489|Secondary|Number of Participants Using Any Contraceptive Method at 8 Months Postpartum|"This was defined as the use of all contraceptive methods, according to self-report at 8 months postpartum. The aim of this measure was to quantify the use of natural methods, such as withdrawal, which, based on the literature, may be higher than reported in DHS surveys."|Data collected at 8 months postpartum||||Participants|||Count of Participants
2588209|NCT02309489|Secondary|Number of Participants Using Long Acting or Permanent (LA/PM) Methods of Contraception at 8 Months Postpartum|This was defined as the number of women using IUDs, implants, female sterilization or male sterilization at 8 months postpartum.|Data collected at 8 months postpartum||||Participants|||Count of Participants
2588210|NCT02309489|Primary|Number of Participants Using Effective Modern Contraception at 8 Months Postpartum|"Effective modern methods were defined as those having a rate of unintended pregnancy per 100 women of 10% or less per year, as commonly used. Based on local availability, these methods were: implants, IUDs, injectables, oral contraceptives, and permanent methods. Each woman was considered a user or non-user for each method."|Data collected at 8 months postpartum||||Participants|||Count of Participants
2588211|NCT02309489|Primary|Number of Participants Practicing Exclusive Breastfeeding at 3 Months Postpartum|"This was defined according to the WHO criteria for exclusive breastfeeding: the infant has received only breastmilk from his/her mother or a wet nurse, or expressed breastmilk, and no other liquids or solids with the exception of drops or syrups consisting of vitamins, mineral supplements or medicines. Although the WHO recommends exclusive breastfeeding for the first 6 months postpartum, 3 months was chosen as the reference period because by that point only 20% of infants are still exclusively breastfed."|Data collected at 3 months postpartum||||Participants|||Count of Participants
2588212|NCT02309489|Primary|Number of Participants Attending the Recommended Number of Postnatal Care Appointments|This was defined as whether women had attended at least two outpatient postnatal care consultations/check-ups in the first six weeks after birth.|Data collected at 3 months postpartum||||Participants|||Count of Participants
2588213|NCT02309411|Other Pre-specified|Anti-factor Xa Values at Specified Time Points|The individual anti-Factor Xa activity was determined ex-vivo using a photometric method. The anti-factor Xa assay is designed to measure plasma heparin, low molecular weight heparin and other anticoagulants. In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.|Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose) and Day 30 (10-16 hours post-dose)|PDS included all subjects with at least one blood sample for clotting tests in accordance with the pharmacodynamic sampling strategy was included.|||microgram per liter (mcg/L)||Standard Deviation|Mean
2588214|NCT02309411|Secondary|Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points|Concentration of rivaroxaban in plasma was measured at Day 1, 15 and 30 at specified time points. In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Day 1 (30-90 minutes, 2.5-4 hours post-dose); Day 15 (2-8 hours post-dose) and Day 30 (10-16 hours post-dose)|PKS included all subjects with at least one pharmacokinetic sample in accordance with the pharmacokinetic sampling strategy.|||microgram per liter (mcg/L)||Geometric Coefficient of Variation|Geometric Mean
2588215|NCT02309411|Secondary|Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points|The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway. Day 30 (10-16 hours post-dose) was considered as a baseline.|Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose)|PDS with evaluable subjects for this end point. PD parameters were evaluated only for subjects who received active study medication.|||Seconds||Standard Deviation|Mean
2588216|NCT02309411|Secondary|Change From Baseline in Prothrombin Time at Specified Time Points|Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade. Day 30 (10-16 hours post-dose) was considered as a baseline.|Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose)|PDS with evaluable subjects for this end point. PD parameters were evaluated only for subjects who received active study medication.|||Seconds||Standard Deviation|Mean
2588217|NCT02309411|Secondary|Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging|The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. At the end of the 30-day treatment period, a repeat imaging of the thrombus was performed. The images of the index event and repeat imaging were adjudicated by the central independent adjudication committee (CIAC). The thrombotic burden at the time of the index event was compared to the thrombotic burden at the time of repeat imaging. The outcome of the adjudication was classified as normalized, improved, no relevant change, deteriorated, or not evaluable. Due to missing repeated imaging, thrombotic burden assessments were not done in some subjects.|At the end of the 30-day treatment period|FAS included all enrolled children (before Amendment 4, all children were randomized by interactive voice/web response system [IxRS], after Amendment 4 all children were assigned to rivaroxaban by IxRS). Screening failures were excluded.|||Participants|||Count of Participants
2588292|NCT02308696|Secondary|Loneliness as Assessed by the Short Scale for Measuring Loneliness in a Large Survey|Investigators will use the Short Scale for Measuring Loneliness in a large survey. Three item measure with a three-point response scale from 1-3, with a score of 1 indicating the least loneliness and a score of 3 indicating the most loneliness.|1 year||||units on a scale||95% Confidence Interval|Mean
2588218|NCT02309411|Secondary|Number of Subjects With Symptomatic Recurrent Venous Thromboembolism|Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence, which is the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE of venous thrombosis, had to be documented using appropriate (repeat) imaging test.|From start of the study treatment up to 30-days post study treatment period (approximately 60 days)|FAS included all enrolled children (before Amendment 4, all children were randomized by interactive voice/web response system [IxRS], after Amendment 4 all children were assigned to rivaroxaban by IxRS). Screening failures were excluded.|||Participants|||Count of Participants
2588219|NCT02309411|Primary|Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding Events|"Major bleeding is defined as overt bleeding and:~associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or~leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or~occurring in a critical site, for example (e.g.) intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or~contributing to death.~Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with:~medical intervention, or~unscheduled contact (visit or telephone call) with a physician, or~cessation (temporary) of study treatment, or~discomfort for the child such as pain or~impairment of activities of daily life (such as loss of school days or hospitalization)."|During or within 2 days after stop of study treatment (up to 32 days)|SAF included all subjects who received at least one dose of the study medication.|||Participants|||Count of Participants
2588220|NCT02309359|Secondary|Number of Treatment-related Treatment-emergent Adverse Events||From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit|Safety population|||Adverse events|||Number
2588221|NCT02309359|Secondary|Number and Percentage of Subjects With Treatment-related Treatment-emergent Adverse Events||From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit|Safety population|||Participants|||Count of Participants
2588222|NCT02309359|Secondary|Number of Treatment-emergent Adverse Events by Severity||From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit|Safety population|||Adverse events|||Number
2588223|NCT02309359|Secondary|Number and Percentage of Subjects With Treatment-emergent Adverse Events by Severity||From first study drug intake until the Week 24 or Early Termination visit. Only safety data through Week 24 is reported as 256 of the 293 subjects who completed the 24-week treatment period rolled-over to the C203 Study and did not perform the FU visit|Safety population|||Participants|||Count of Participants
2588224|NCT02309359|Secondary|Number of Subjects With Development of a Treatment-emergent Antidrug Antibody Response||from baseline till follow-up (FU) (i.e., 12 weeks after last study drug dosing at Week 22 or after early treatment discontinuation)|Safety population|||Participants|||Count of Participants
2588225|NCT02309359|Secondary|Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R) at Weeks 12 and 24|Values below the limit of quantification are imputed with the lower limit of quantification (LLOQ).|from baseline till Week 24|"Safety Population; Number Analyzed reflect the number of subjects with data available at that specific timepoint."|||ng/mL||Standard Error|Mean
2588226|NCT02309359|Secondary|Pharmacokinetics: ALX-0061 Concentration in Serum at Weeks 12 and 24|ALX-0061 concentrations were only measured in samples of subjects randomized to any of the ALX-0061 treatment arms. Samples were taken predose at the concerned visits.|at Week 12 and Week 24 visits|PK population|||micrograms/milliliter||Standard Deviation|Geometric Mean
2588227|NCT02309359|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale at Weeks 12 and 24|The FACIT Measurement System is a collection of health-related quality of life questionnaires that assess multidimensional health status in people with various chronic illnesses. The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.|from baseline till Week 24|"Intent-to-treat population; Number Analyzed reflect the number of non-missing, non-imputed observations at that specific timepoint."|||score on a scale||Standard Error|Mean
2588228|NCT02309359|Secondary|Change From Baseline in Mental Component Score of Short Form Health Survey (SF-36) at Weeks 12 and 24|The Short Form (36) Health Survey (SF-36) consists of 36 items that can be summarized into 8 domains: physical functioning, role limitations due to physical health problems (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional problems (role-emotional), and mental health. Two summary measures, the physical component summary and the mental component summary, can be derived based on these domain scores. Each score is directly transformed into a 0-100 score on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.|from baseline till Week 24|"Intent-to-treat population; Number Analyzed reflect the number of non-missing, non-imputed observations at that specific timepoint."|||score on a scale||Standard Error|Mean
2588241|NCT02309359|Secondary|Number and Percentage of Subjects With ACR50 Response at Weeks 12 and 24|"ACR50 response is defined as:~50% improvement in TJC (68 joints) relative to Week 0 AND~50% improvement in SJC (66 joints) relative to Week 0 AND~50% improvement in 3 of the following 5 areas relative to Week 0:~Subject's Assessment of Pain (100 mm - VAS)~Subject's Global Assessment of Disease Activity (VASPA)~Physician's Global Assessment of Disease Activity (VASPHA)~Subject's assessment of physical function as measured by HAQ-DI~CRP level~This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders."|24 weeks|Intent-to-treat population|||Participants|||Count of Participants
2588229|NCT02309359|Secondary|Change From Baseline in Physical Component Score of Short Form Health Survey (SF-36) at Weeks 12 and 24|The Short Form (36) Health Survey (SF-36) consists of 36 items that can be summarized into 8 domains: physical functioning, role limitations due to physical health problems (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional problems (role-emotional), and mental health. Two summary measures, the physical component summary and the mental component summary, can be derived based on these domain scores. Each score is directly transformed into a 0-100 score on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.|from baseline till Week 24|"Intent-to-treat population; Number Analyzed reflect the number of non-missing, non-imputed observations at that specific timepoint."|||score on a scale||Standard Error|Mean
2588230|NCT02309359|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 12 and 24|"The HAQ-DI is a 20-question instrument which assesses the degree of difficulty the subject had in accomplishing tasks in 8 functional areas over the previous week. The 8 areas are: dressing and grooming, hygiene, arising, reach, eating, grip, walking, common daily activities. Within each area, subjects report the amount of difficulty they have in performing the specific items. There are 4 response options ranging from: 0 = No Difficulty, 1 = With Some Difficulty, 2 = With Much Difficulty, 3 = Unable to Do. The 8 areas are each given a single score equal to the maximum value of their component activities (0, 1, 2, or 3). The sum of the area scores is then divided by the number of areas answered to obtain the final HAQ score (rounded to the nearest value evenly divisible by 0.125). The final HAQ-DI score ranges from 0 to 3. A high score means a high degree of disability (=worse outcome).~Missing values were imputed with the last non-missing observation."|from baseline till Week 24|Intent-to-treat population|||score on a scale||Standard Error|Mean
2588231|NCT02309359|Secondary|Number and Percentage of Subjects in Remission Using Boolean Defined Remission Criteria at Weeks 12 and 24|"Boolean remission: tender joint count (TJC)28 ≤ 1 and swollen joint count (SJC)28 ≤ 1 and VASPA (cm) ≤ 1 and CRP (mg/dL) ≤ 1~This endpoint was analyzed using non-responder imputation (NRI), i.e., subjects with missing response at the concerned visit were treated as non responders."|24 weeks|Intent-to-treat population|||Participants|||Count of Participants
2588232|NCT02309359|Secondary|Number and Percentage of Subjects in Remission Using CDAI at Weeks 12 and 24|"CDAI = TJC28 + SJC28 + VASPA + VASPHA~Remission: CDAI ≤ 2.8~This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders."|24 weeks|Intent-to-treat Population|||Participants|||Count of Participants
2588233|NCT02309359|Secondary|Number and Percentage of Subjects in Remission Using SDAI at Weeks 12 and 24|"SDAI = TJC28 + SJC28 + VASPA + VASPHA + CRP (mg/dL)~Remission: SDAI ≤ 3.3~This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders."|24 weeks|Intent-to-treat population|||Participants|||Count of Participants
2588234|NCT02309359|Secondary|Number and Percentage of Subjects in Remission Using DAS28 (ESR) at Weeks 12 and 24|"DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln[ESR]) +(0.014 × VASPA)~Remission = DAS28(ESR) < 2.6~This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders."|24 weeks|Intent-to-treat population|||Participants|||Count of Participants
2588235|NCT02309359|Secondary|Number and Percentage of Subjects With European League Against Rheumatism (EULAR) (CRP) Good Response at Weeks 12 and 24|"EULAR good response is defined as an improvement of >1.2 in DAS28 (CRP) relative to baseline.~This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders."|24 weeks|Intent-to-treat population|||Participants|||Count of Participants
2588236|NCT02309359|Secondary|Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Weeks 12 and 24|"CDAI = TJC28 + SJC28 + VASPA + VASPHA~Low disease activity: 2.8 < CDAI ≤ 10~Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders."|24 weeks|Intent-to-treat population|||Participants|||Count of Participants
2588237|NCT02309359|Secondary|Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Weeks 12 and 24|"SDAI = TJC28 + SJC28 + Patient's Global Assessment of Disease Activity (VASPA) + Physician's Global Assessment of Disease Activity (VASPHA) + CRP (mg/dL)~Low disease activity: 3.3 < SDAI ≤ 11.0~Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders."|24 weeks|Intent-to-treat population|||Participants|||Count of Participants
2588238|NCT02309359|Secondary|Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Weeks 12 and 24|"DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln[ESR]) +(0.014 × VASPA)~Low disease activity = 2.6 ≤ DAS28 ≤ 3.2~Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders."|24 weeks|Intent-to-treat population|||Participants|||Count of Participants
2588239|NCT02309359|Secondary|Number and Percentage of Subjects With Low Disease Activity (LDA) Using Disease Activity Score 28 (DAS28) Using C-reactive Protein (CRP) at Weeks 12 and 24|"DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln[CRP+1]) + (0.014 × VASPA) + 0.96~Low disease activity = 2.6 ≤ DAS28 ≤ 3.2~This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders."|24 weeks|Intent-to-treat population|||Participants|||Count of Participants
2588240|NCT02309359|Secondary|Number and Percentage of Subjects With ACR70 Response at Weeks 12 and 24|"ACR70 response is defined as:~70% improvement in TJC (68 joints) relative to Week 0 AND~70% improvement in SJC (66 joints) relative to Week 0 AND~70% improvement in 3 of the following 5 areas relative to Week 0:~Subject's Assessment of Pain (100 mm - VAS)~Subject's Global Assessment of Disease Activity (VASPA)~Physician's Global Assessment of Disease Activity (VASPHA)~Subject's assessment of physical function as measured by HAQ-DI~CRP level~This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non responders."|24 weeks|Intent-to-treat population|||Participants|||Count of Participants
2588332|NCT02308189|Secondary|Muscle Strength % of Change|Maximal muscle strength|Baseline and following 10-weeks of exercise training. Values calculated are % of change|Study participants completing study.|||percentage of change from baseline||Standard Deviation|Mean
2588242|NCT02309359|Secondary|Number and Percentage of Subjects With ACR20 Response at Week 24|"ACR 20 response is defined as:~20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND~20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND~20% improvement in 3 of the following 5 areas relative to Week 0:~Subject's Assessment of Pain (100 mm - visual analogue scale [VAS])~Subject's Global Assessment of Disease Activity (VASPA)~Physician's Global Assessment of Disease Activity (VASPHA)~Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI)~C-reactive protein (CRP) level~This endpoint was analyzed using NRI, i.e., subjects with missing response at Week 24 were treated as non responders."|24 weeks|Intent-to-treat population|||Participants|||Count of Participants
2588243|NCT02309359|Primary|Number and Percentage of Subjects Achieving American College of Rheumatology (ACR) 20 Response at Week 12|"ACR 20 response is defined as:~20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND~20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND~20% improvement in 3 of the following 5 areas relative to Week 0:~Subject's Assessment of Pain (100 mm - visual analogue scale [VAS])~Subject's Global Assessment of Disease Activity (VASPA)~Physician's Global Assessment of Disease Activity (VASPHA)~Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI)~C-reactive protein (CRP) level~The primary endpoint was analyzed using non-responder imputation (NRI), i.e., subjects with missing ACR20 response at Week 12 were treated as non responders."|Week 12|Intent-to-treat population|||Participants|||Count of Participants
2588244|NCT02309294|Primary|Number of Subjects That Showed no Significant Irritation|Score of less than or equal to 1.2 on the Cumulative Irritation Test scale (0-5).|14 days||||participants|||Number
2588245|NCT02309112|Secondary|Patient Adherence Rate to Yoga Intervention|% of patients who completed their yoga intervention|6 weeks|Male (n=4) and female (n=11) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada|||percentage of participants|||Number
2588246|NCT02309112|Other Pre-specified|Patient's Health-related Quality of Life|Assessed via an online survey of a validated, cancer-specific survey instrument measuring health-related quality of life (QOL-CA/CS), (0 worst; 10 best possible). The QOL-CA/CS score was assessed pre and post yoga intervention.|6 weeks|Male (n=3) and female (n=9) adults undergoing conventional treatment for cancer diagnosis in Vancouver, Canada.|||units on quality of life scale||Full Range|Mean
2588247|NCT02309112|Other Pre-specified|Financial Cost of Delivering Yoga Intervention in a Clinical Setting|Calculation of the per participant cost of three types of yoga interventions (Group A, B and C). The financial data included cost of in-person instruction, cost of materials and time to design and implement intervention per participant in each yoga group.|10 weeks|Male (n=3) and female (n=10) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada|||dollars (USD)|||Number
2588248|NCT02309112|Other Pre-specified|Patient Acceptability of Yoga Intervention|Amount of satisfaction for adult cancer patients assessed via Likert-scale surveys; on scale of 1 to 10, 1 being not satisfied; 10 being extremely satisfied (i.e higher number, better outcome).|6 weeks|Adult male (n=3) and female (n=9) cancer patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada|||units on satisfaction scale||Full Range|Mean
2588249|NCT02309112|Secondary|Patient Adherence to Yoga Intervention|Number of participants who completed their yoga intervention|6 weeks|Male (n=4) and female (n=11) adult patients undergoing conventional treatment for cancer diagnosis in Vancouver, Canada|||participants|||Number
2588250|NCT02309112|Primary|Feasibility of Patient Recruitment to Yoga Intervention|Number of participants eligible for randomization to yoga intervention during cancer treatment|10 weeks|Male (n=4) and female (n=11) adult patients undergoing conventional treatment in Vancouver, Canada for a cancer diagnosis; who have not participated in yoga the past month.|||participants|||Number
2588251|NCT02309099|Secondary|Difference in Localization RMS Error With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time|Participants identified a speech-shaped noise source presented at various presentation levels within an 11-speaker array. Participants localized the sound source with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone. The RMS error (degrees) was estimated; a lower degree is more accurate/better localization of the sound source. The resultant score reported here is a difference in mean RMS error between cochlear implant on versus off; a negative difference translates to a better score with the cochlear implant on, whereas a positive difference translates to a worse score with the cochlear implant on.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||Degrees||Full Range|Mean
2588252|NCT02309099|Secondary|Difference in BKB-SIN Scores (S0NContra) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time|Testing open-set sentence understanding with concurrent background noise present at various levels. Recorded BKB-SIN lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech was presented at 0 degrees azimuth and noise to the contralateral ear in this condition (S0NContra). Resultant score is a difference in the mean signal-to-noise ratio at which the participant scores 50% of the target words correct between cochlear implant on versus off; a negative difference translates to a better score with the cochlear implant on, whereas a positive difference translates to a worse score with the cochlear implant on.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||dB SNR||Full Range|Mean
2588260|NCT02309099|Primary|Change in Reported Subjective Benefit on the Qualities of Hearing Domain of the SSQ Scale Over Time|Participants reported subjective device benefit in qualities of hearing (including ease of listening and the naturalness, clarity, and identifiability of different sounds) by marking on a visual analog scale from 0 to 10, with 0 being the minimum benefit and 10 being maximal benefit. Participants based their report on daily listening with the cochlear implant on and contralateral ear open. A higher score is greater subjective benefit reported by the participant.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||Score on a scale||Full Range|Mean
2588253|NCT02309099|Secondary|Difference in BKB-SIN Scores (S0NCI) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time|Testing open-set sentence understanding with concurrent background noise present at various levels. Recorded BKB-SIN lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech was presented at 0 degrees azimuth and noise to the implanted side in this condition (S0NCI). Resultant score is a difference in the mean signal-to-noise ratio at which the participant scores 50% of the target words correct between cochlear implant on versus off; a negative difference translates to a better score with the cochlear implant on, whereas a positive difference translates to a worse score with the cochlear implant on.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||dB SNR||Full Range|Mean
2588254|NCT02309099|Secondary|Difference in BKB-SIN Scores (S0N0) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time|Testing open-set sentence understanding with concurrent background noise present at various levels. Recorded BKB-SIN lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech and noise were colocated in this condition (S0N0). Resultant score is a difference in the mean signal-to-noise ratio at which the participant scores 50% of the target words correct between cochlear implant on versus off; a negative difference translates to a better score with the cochlear implant on, whereas a positive difference translates to a worse score with the cochlear implant on.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||dB SNR||Full Range|Mean
2588255|NCT02309099|Secondary|Difference in AzBio Sentences in Noise Scores (S0NContra) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time|Testing open-set sentence understanding with concurrent background noise present at 0 dB SNR. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech was presented at 0 degrees azimuth and noise to the contralateral ear in this condition (S0NContra). Resultant score is a difference in mean percentage of words correct between cochlear implant on versus off; a positive difference translates to a higher score with the cochlear implant on, whereas a negative difference translates to a lower score with the cochlear implant on.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||Percentage correct words||Full Range|Mean
2588256|NCT02309099|Secondary|Difference in AzBio Sentences in Noise Scores (S0NCI) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time|Testing open-set sentence understanding with concurrent background noise present at 0 dB SNR. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech was presented at 0 degrees azimuth and noise to the implanted side in this condition (S0NCI). Resultant score is a difference in mean percentage of words correct between cochlear implant on versus off; a positive difference translates to a higher score with the cochlear implant on, whereas a negative difference translates to a lower score with the cochlear implant on.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||Percentage correct words||Full Range|Mean
2588257|NCT02309099|Secondary|Difference in AzBio Sentences in Noise Scores (S0N0) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time|Testing open-set sentence understanding with concurrent background noise present at 0 dB SNR. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech and noise were colocated in this condition (S0N0). Resultant score is a difference in the mean percentage of words correct between cochlear implant on versus off; a positive score translates to a higher score with the cochlear implant on, whereas a negative difference translates to a lower difference with the cochlear implant on.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||Percentage correct words||Full Range|Mean
2588258|NCT02309099|Secondary|Difference in AzBio Sentences in Quiet Scores With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time|Testing open-set sentence understanding with no background noise present. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech and noise were collocated in this condition. Resultant score is a difference in mean percentage of words correct between cochlear implant on versus off; a positive difference translates to a higher score with the cochlear implant on, whereas a negative difference translates to a lower score with the cochlear implant on.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||Percentage correct words||Full Range|Mean
2588259|NCT02309099|Primary|Change in Reported Subjective Difficulty Frequency on the Abbreviated Profile of Hearing Aid Benefit (APHAB) Over Time|Participants reported frequency of subjective difficulty in specific listening situations. Participants based their report on daily listening with the cochlear implant on and contralateral ear open. The score is percentage of how frequently participants experience difficulty in specific listening situations, ranging from 1% (Never) to 99% (Always). A lower global score is less reported difficulty frequency by the participant.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||Percentage of situations with difficulty||Full Range|Mean
2588261|NCT02309099|Primary|Change in Reported Subjective Benefit on the Spatial Domain of the SSQ Scale Over Time|Participants reported subjective device benefit for the directional, distance, and movement components of spatial hearing by marking on a visual analog scale from 0 to 10, with 0 being the minimum benefit and 10 being maximal benefit. Participants based their report on daily listening with the cochlear implant on and contralateral ear open. A higher score is greater subjective benefit reported by the participant.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||Score on a scale||Full Range|Mean
2588262|NCT02309099|Primary|Change in Reported Subjective Benefit on the Speech Domain of the Speech, Spatial and Qualities of Hearing (SSQ) Scale Over Time|Participants reported subjective device benefit when hearing speech in a variety of competing contexts by marking on a visual analog scale from 0 to 10, with 0 being the minimum benefit and 10 being maximal benefit. Participants based their report on daily listening with the cochlear implant on and contralateral ear open. A higher score is greater subjective benefit reported by the participant.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||Scores on a scale||Full Range|Mean
2588263|NCT02309099|Primary|Change in Localization Root-mean-squared (RMS) Error Over Time|Participants identified a speech-shaped noise source presented at various presentation levels within an 11-speaker array. Participants localized the sound source with the cochlear implant on and contralateral ear open. The RMS error (degrees) was estimated; a lower degree is more accurate/better localization of the sound source.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||Degrees||Full Range|Mean
2588264|NCT02309099|Primary|Change in BKB-SIN Scores (S0NContra) Over Time|Testing open-set sentence understanding with concurrent background noise present at various levels. Recorded BKB-SIN lists were presented to the participant while listening with the cochlear implant on and contralateral ear open; the speech was presented at 0 degrees azimuth and noise to the contralateral ear in this condition (S0NContra). Resultant score is the signal-to-noise ratio at which the participant scores 50% of the target words correct. A lower score is better.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||dB SNR||Full Range|Mean
2588265|NCT02309099|Primary|Change in BKB-SIN Scores (S0NCI) Over Time|Testing open-set sentence understanding with concurrent background noise present at various levels. Recorded BKB-SIN lists were presented to the participant while listening with the cochlear implant on and contralateral ear open; the speech was presented at 0 degrees azimuth and noise to the implanted side in this condition (S0NCI). Resultant score is the signal-to-noise ratio at which the participant scores 50% of the target words correct. A lower score is better.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||dB SNR||Full Range|Mean
2588266|NCT02309099|Primary|Change in Bamford-Kowal-Bench-Speech-in-Noise (BKB-SIN) Scores (S0N0) Over Time|Testing open-set sentence understanding with concurrent background noise present at various levels. Recorded BKB-SIN lists were presented to the participant while listening with the cochlear implant on and contralateral ear open; the speech and noise were colocated in this condition (S0N0). Resultant score is the signal-to-noise ratio in decibels (dB SNR) at which the participant scores 50% of the target words correct. A lower score is better.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||dB SNR||Full Range|Mean
2588267|NCT02309099|Primary|Change in AzBio Sentences in Noise Scores (S0NContra) Over Time|Testing open-set sentence understanding with concurrent background noise present at 0 dB SNR. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open; the speech was presented at 0 degrees azimuth and noise to the contralateral ear in this condition (S0NContra). Resultant score is a percentage of words correct. A higher score is better.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||Percentage of words correct||Full Range|Mean
2588268|NCT02309099|Primary|Change in AzBio Sentences in Noise Scores (S0NCI) Over Time|Testing open-set sentence understanding with concurrent background noise present at 0 dB SNR. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open; the speech was presented at 0 degrees azimuth and noise to the implanted side in this condition (S0NCI). Resultant score is a percentage of words correct. A higher score is better.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||Percentage of words correct||Full Range|Mean
2588269|NCT02309099|Primary|Change in AzBio Sentences in Noise Scores (S0N0) Over Time|Testing open-set sentence understanding with concurrent background noise present at 0 decibel signal-to-noise ratio (dB SNR). Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open; the speech and noise were colocated in this condition (S0N0). Resultant score is a percentage of words correct. A higher score is better.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||Percentage of words correct||Full Range|Mean
2588288|NCT02308696|Secondary|Mobility Disability as Assessed by the Rosow-Breslow Scale|The Rosow-Breslow scale is a composite measure of mobility disability. The composite score ranges from 0 to 3 with higher scores indicating greater disability.|1 year||||units on a scale||95% Confidence Interval|Mean
2588380|NCT02308163|Secondary|Change From Baseline in CRP at Week 12|Higher CRP indicates greater disease activity.|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||mg/dL||Standard Deviation|Mean
2588270|NCT02309099|Primary|Change in Arizona Biomedical Institute (AzBio) Sentences in Quiet Scores Over Time|Testing open-set sentence understanding with no background noise present. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open. Resultant score is a percentage of words correct. A higher score is better.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||Percentage of words correct||Full Range|Mean
2588271|NCT02309099|Primary|Change in Consonant-Nucleus-Consonant (CNC) Words Scores Over Time|Testing open-set word understanding. Recorded CNC Words lists were presented to the participant while listening to the cochlear implant alone and contralateral ear plugged/masked. Resultant score is a percentage of words correct. A higher score is better.|Intervals within the first 12 months of device use|Cochlear Implant Use/Follow-Up One participant in the Meniere’s disease group did not complete the 12-month follow-up interval (protocol deviation) and is excluded from that analysis.|||Percentage of words correct||Full Range|Mean
2588272|NCT02308787|Other Pre-specified|Total Blood Volume (TBV) Processed|The number of times the patient's total blood volume is processed during the apheresis procedure.|Post each Spectra Optia Apheresis Procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.|||Number of TBVs processed|Participants|Standard Deviation|Mean
2588273|NCT02308787|Other Pre-specified|Waste Bag Volume||Post each Spectra Optia Apheresis Procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.|||mL|Participants|Standard Deviation|Mean
2588274|NCT02308787|Other Pre-specified|Procedure Duration||Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.|||minutes|Participants|Standard Deviation|Mean
2588275|NCT02308787|Other Pre-specified|Average Inlet Flow Rate||Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.|||mL/min|Participants|Standard Deviation|Mean
2588276|NCT02308787|Other Pre-specified|Whole Blood Processed (mL)|Volume of patients blood processed during the apheresis procedure.|Post each Spectra Optia Apheresis Procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.|||mL|Participants|Standard Deviation|Mean
2588277|NCT02308787|Other Pre-specified|Patient's WBC Count Post-depletion Procedure||Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.|||cells x 10^9/L|Participants|Standard Deviation|Mean
2588278|NCT02308787|Other Pre-specified|Patients WBC Count Pre-depletion Procedure||Prior to each Spectra Optia Apheresis Procedure||||cells x 10^9/L|Participants|Standard Deviation|Mean
2588279|NCT02308787|Other Pre-specified|Patient's Platelet Count Post-depletion Procedure||Participants were followed for the duration of the procedure and an average of 2.5 hours after the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.|||cells x 10^3/L|Participants|Standard Deviation|Mean
2588280|NCT02308787|Other Pre-specified|Patient's Platelet Count Pre-depletion Procedure||Prior to each Spectra Optia Apheresis Procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.|||cells x 10^3/L|Participants|Standard Deviation|Mean
2588281|NCT02308787|Primary|Adverse Events||during the apheresis procedure (from the moment the patient is connected until he is disconnected from the device) and device or procedure related adverse events until discharge from Apheresis Unit (On average, half hour after end of procedure).|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.|||Number of subjects with at least 1 AE|||Number
2588282|NCT02308787|Primary|Percent of Processed Platelets (PLT) Which Are Collected i.e. Collection Efficiency for Platelets Achieved by Spectra Optia.|(PLT/µL product x product volume) / ((PLTpre + PLTpost) / 2) x total processed blood volume)|on average this will be within 15 minutes after the end of the procedure|At Site 2, percent processed platelets could only be calculated for 1 procedure in Subject 214; no waste bag (depletion product) platelet counts were available for the other 9 procedures performed at Site 2.|||% of processed platelets|Participants|Standard Deviation|Mean
2588283|NCT02308787|Primary|Percent Change in Platelet (PLT) Count in Patient Blood Following Apheresis Procedure|(PLTpre - PLTpost) / PLTpre x 100%|on average this will be within 15 minutes after the end of the procedure|Data were collected for 12 subjects who underwent a total of 20 PLTD procedures at 2 European sites.|||% change in PLT count in subject blood|Participants|Standard Deviation|Mean
2588284|NCT02308748|Secondary|Change in Placebo Corrected Change From Baseline QTc Interval on the ECG Measured in Milliseconds When Moxifloxacin is Administered With Diltiazem at the Evening Dose Compared to When Moxifloxacin is Administered Alone at Afternoon Dose on Treatment Day.|Evening dose (moxifloxacin+diltiazem) versus afternoon dose (diltiazem alone).|5 weeks|All study participants that completed placebo, moxifloxacin and moxifloxacin + diltiazem|||ms||95% Confidence Interval|Mean
2588285|NCT02308748|Primary|Change in Placebo Corrected Change From Baseline QTc and J-Tpeakc Intervals on the ECG Measured in Milliseconds When Dofetilide is Administered With Mexiletine or Lidocaine Compared to When Dofetilide is Administered Alone at Evening Dose on Treatment Day|After 3rd dose of mexiletine or lidocaine (evening dose) on treatment day when combined with dofetilide to evening dose on dofetilide alone day.|5 weeks|All study participants that completed placebo and dofetilide alone as well as dofetilide + mexiletine and/or dofetilide + lidocaine|||ms||95% Confidence Interval|Mean
2588286|NCT02308696|Secondary|Medical Conditions as Assessed by the Medical Conditions Questionnaire (MCQ)|Medical Conditions Questionnaire has 9 yes/no questions on whether or not participants have ever had a condition like heart disease, cancer, diabetes, etc. It ranges from 0 to 9, with 0 indicating better overall health and 9 indicating poor overall health.|1 year||||units on a scale||95% Confidence Interval|Mean
2588287|NCT02308696|Secondary|Physical Health as Assessed by the NAGI Test|The NAGI test is a nine-item instrument scored from 1-5, with higher scores indicating less physical health.|1 year||||units on a scale||95% Confidence Interval|Mean
2588293|NCT02308696|Secondary|Anxiety Symptoms as Assessed by the 5-item Version of the Geriatric Anxiety Inventory Short Form|Investigators will use the 5-item version of the Geriatric Anxiety Inventory Short Form to measure anxiety symptoms. The scale is 0 to 5, with 0 points indicating zero anxiety symptoms and 5 indicating the most anxiety symptoms.|1 year||||units on a scale||95% Confidence Interval|Mean
2588294|NCT02308696|Secondary|Depressive Symptoms as Assessed by the 10 Item Version of the Center of Epidemiologic Studies-Depression Scale|Investigators will use the 10 item version of the Center of Epidemiologic Studies-Depression scale to assess depressive symptoms. The possible range of scores is 0 to 10, with a score of zero indicating no depressive symptoms and a score of 10 indicating the most depressive symptoms|1 year||||units on a scale||95% Confidence Interval|Mean
2588295|NCT02308696|Secondary|Health Status and Quality of Life as Assessed by the Short Form-12 Question Physical Component Summary (SF-12 PCS) and the Short Form-12 Mental Component Summary (SF-12 MCS).|Investigators will use the Short Form-12 question Physical Component Summary (SF-12 PCS) and the Short Form-12 Mental component Summary (SF-12 MCS) to measure physical and mental health status. Summary scores range from 0-100, with higher scores indicating a better self-reported level of health.|1 year||||units on a scale||95% Confidence Interval|Mean
2588296|NCT02308696|Primary|Number of Hospitalizations, Emergency Department Visits, and Urgent Care Visits|Investigators will ask participants to report their hospitalizations, ED and Urgent Care visits over the course of a 1 year follow up|1 year|It was determined that baseline characteristics between the groups were not comparable despite frequency-based matching on age, gender, race/ethnicity. A propensity score analytic method was used to make the groups more comparable at baseline. The participant numbers are based on this model (218, 227) to account for baseline differences.|||Participants|||Count of Participants
2588297|NCT02308540|Other Pre-specified|Booster Effect: Ratio of Immunoglobulin G (IgG) Geometric Mean Concentration 4 Weeks Post Vaccination 3 Versus 4 Weeks Post Booster Among Infants Receiving a Booster Dose|Defined as the ratio of IgG geometric mean concentration (GMC) measured 4 weeks post-infant booster dose, to GMC measured 4 weeks after the 3-dose primary series. Infants received the booster dose at least four weeks after they received routine Expanded Program on Immunization (EPI) vaccines, which occurred at 9 months of age. Thus, the time frame was at least 24 weeks but may have been longer.|24-26 weeks|This population is infants who had a booster vaccination of either PCV-10 or Prevenar-13. The evaluable group differs for individual serotypes due to non-reportable results.|||concentration ratio||90% Confidence Interval|Geometric Mean
2588298|NCT02308540|Other Pre-specified|Antibody Persistence of Immunoglobulin G (IgG) Geometric Mean Concentration Among Infants Receiving a Booster Dose|Defined as the ratio of IgG geometric mean concentration (GMC) measured prior to the infant booster dose, to GMC measured 4 weeks after the 3-dose primary series. Infants received the booster dose at least four weeks after they received routine Expanded Program on Immunization (EPI) vaccines, which occurred at 9 months of age. Thus, the time frame was at least 20 weeks but may have been longer.|20-23 weeks|This population is infants who had a booster vaccination of either PCV-10 or Prevenar-13. The evaluable group differs for individual serotypes due to non-reportable results.|||concentration ratio||90% Confidence Interval|Geometric Mean
2588299|NCT02308540|Other Pre-specified|Geometric Mean Fold Rise (GMFR) in Immunoglobulin G (IgG) Among Infants Receiving a Booster Dose|Using enzyme-linked immunosorbent assay (ELISA). Blood samples were collected for immunogenicity testing before and 28 days after the booster dose for infants.|4 weeks (28 days)|This population is infants who had a booster vaccination of either PCV-10 or Prevenar-13. The evaluable group differs for individual serotypes due to NR results.|||fold change||90% Confidence Interval|Geometric Mean
2588300|NCT02308540|Other Pre-specified|Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) by Time Point (4 Weeks Post Vaccination 3, Pre Booster, 4 Weeks Post Booster) Among Infants Receiving Booster Dose|Using enzyme-linked immunosorbent assay (ELISA). Blood samples were collected for immunogenicity testing at 4 weeks post vaccination 3, and before and 28 days after the booster dose for infants.|4 weeks (28 days)|This is the population of infants who received a booster dose of either PCV-10 or Prevenar-13. The evaluable group differs for individual serotypes due to NR results.|||µg/mL||90% Confidence Interval|Geometric Mean
2588301|NCT02308540|Other Pre-specified|Occurrence of All Adverse Events (AEs) and SAEs Following a Booster Vaccination Among Infants, by Type and Severity|Unsolicited adverse events following a booster dose of SIILPCV10 occurring in 5% or greater of study participants. Unless specifically stated, AEs are considered unrelated.|4 weeks (28 days)|A subset of the infant cohort PP_IMM who were eligible for the booster phase, had not yet received the Prevenar 13 booster that was offered to infants in the SIILPCV10 group as part of the primary phase of the study and who contributed at least some safety and/or immunogenicity data.|||Participants|||Count of Participants
2588302|NCT02308540|Other Pre-specified|Infant Subjects Experiencing Local and Systemic Reactogenicity After Booster Vaccination, by Severity|"Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 [none], 1 [mild], 2 [moderate], 3 [severe], 4 [potentially life threatening]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times:~At 30 (± 10) minutes following booster vaccination~Daily by field workers during Days 1 to 6 post vaccination~In the clinic on 7 days (+3) following the vaccination"|7 days|A subset of the infant cohort who were eligible for the booster phase, had not yet received the Prevenar 13 booster that was offered to infants in the SIILPCV10 group as part of the primary phase of the study and who contributed at least some safety and/or immunogenicity data.|||Participants|||Count of Participants
2588303|NCT02308540|Secondary|Number and Percentage of Immunoglobulin G (IgG) Seroresponders Against Pentavalent Vaccine Components|"Serum samples were collected 28 days after the third vaccination for infants to determine the ELISA IgG concentration for each component of the co administered pentavalent vaccine (DTwP-HepB-Hib) . Seroresponse was defined as equal to or greater concentrations for:~Diptheria toxoid: 0.1 IU/mL~Hepatitis B: 10 milli-International unit (mIU) /mL~Hib: 0.15 mcg/mL~Tetanus toxoid: 0.1 IU/mL"|84 days|All subjects who receive all study vaccines per the assigned treatment group, and had post-dose immunogenicity measurement(s) with no major protocol violations that were determined to potentially interfere with immune response to the study vaccine.|||Participants|||Count of Participants
2590385|NCT02284464|Secondary|Assess the Adherence to Immunosuppressive Therapy in the Two Treatment Groups|The Basle scale was used to assess adherence (BAASIS questionnaire) to immunosuppressive therapy.|At 24 months||||Participants|||Count of Participants
2588304|NCT02308540|Secondary|Number and Percentage of Functional (OPA) Infant Seroresponders, by Serotype|The functional activity of the immune response to the 10 serotypes contained in SIILPCV10 was determined in randomly selected subsets of the infant cohort in the same serum samples collected 28 days after the completion of the primary series. This activity was determined using the 4-fold multiplexed OPA developed at the University of Alabama at Birmingham.|84 days|Randomly selected subsets of the infant cohort|||Participants|||Count of Participants
2588305|NCT02308540|Secondary|Functional Antibody (OPA) Geometric Mean Titers|The functional activity of the IgG response to the 10 serotypes contained in SIILPCV10 was determined in randomly selected subsets of the infant and toddler cohorts and all adult subjects in the same serum samples collected 28 days after the last vaccinations. This activity was determined using the 4-fold multiplexed OPA developed at the University of Alabama at Birmingham.|4 weeks after last vaccination|Randomly selected subsets of the infant and toddler cohorts and all adult subjects|||titer||90% Confidence Interval|Geometric Mean
2588306|NCT02308540|Secondary|Number and Percentage of Immunoglobulin G (IgG) Seroresponders Among Infants, by Serotype|Seroresponse was defined as ≥ 0.35 µg/mL. In infants, serum samples were collected 28 days after receipt of three doses of the vaccine to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.|4 weeks after third dose|All subjects who received all study vaccines per the assigned treatment group, and had post-dose immunogenicity measurement(s) with no major protocol violations that were determined to potentially interfere with immune response to the study vaccine.|||Participants|||Count of Participants
2588307|NCT02308540|Secondary|Geometric Mean Fold Rise (GMFR) of Immunoglobulin G (IgG) in Toddlers, by Serotype|Serum samples were collected before the first vaccination and 28 days after the last vaccination for adults and toddlers and 28 days after the completion of the primary series for infants to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10. Blood samples were also collected for immunogenicity testing before and 28 days after the booster dose for infants. Baseline serum samples for infants and adults were not assayed. The IgG concentration was also determined for each component of the co administered pentavalent vaccine (DTwP-HepB-Hib) in sera from the infant cohort. If there were limitations to blood volumes, appropriate subsets and priorities for immune testing were established with the immunology laboratories to ensure measurements were unbiased and representative of the entire cohort.|4 weeks after vaccination (28 days)|The evaluable group differs for individual serotypes due to non-reportable results.|||fold change||90% Confidence Interval|Geometric Mean
2588308|NCT02308540|Secondary|Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Infants|Serum samples were collected 28 days after the third vaccination for infants to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.|4 weeks after the third dose|All subjects who received all study vaccines per the assigned treatment group, and had post-dose immunogenicity measurement(s) with no major protocol violations that were determined to potentially interfere with immune response to the study vaccine.|||µg/mL||90% Confidence Interval|Geometric Mean
2588309|NCT02308540|Secondary|Geometric Mean Concentration of Immunoglobulin G (IgG) 4 Weeks After Vaccination for Toddlers|Serum samples were collected 28 days after vaccination for toddlers to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.|4 weeks after vaccination|All subjects who received the study vaccine per the assigned treatment group, and had post-dose immunogenicity measurement(s) with no major protocol violations that were determined to potentially interfere with immune response to the study vaccine.|||µg/mL||90% Confidence Interval|Geometric Mean
2588310|NCT02308540|Secondary|Geometric Mean Concentration of Immunoglobulin G (IgG) for Adults|Serum samples were collected 28 days after the vaccination in adults to determine the ELISA IgG concentration for all 10 serotypes contained in SIILPCV10.|4 weeks after vaccination|All subjects who received the study vaccine per the assigned treatment group, and had post-dose immunogenicity measurement(s) with no major protocol violations that were determined to potentially interfere with immune response to the study vaccine.|||µg/mL||90% Confidence Interval|Geometric Mean
2588311|NCT02308540|Primary|Occurrence, Severity and Relatedness of Clinically Significant Hematological and Biochemistry Lab Values in Adults and Toddlers|Blood samples were collected for safety hematology and clinical chemistry evaluations, organ function tests, and, for adults, coagulation panel evaluation. Laboratory assessments were only performed at baseline for infants. Testing for HIV was undertaken only following pre-test counseling of the subject/subject's parent as to the implications of the test result. Post test counseling was also undertaken, and on the basis of a positive result the subject and subject's parents would have been referred on for HIV care according to normal local practice in The Gambia.|7 days after vaccination|This table displays vaccinated adults and toddlers only. Infants had laboratory tests only at screening.|||Participants|||Count of Participants
2588312|NCT02308540|Primary|Occurrence, Severity and Relatedness of All Adverse Events in Infants|Reported here are adverse events that occurred in 5% or more of the infant cohort. Booster dose safety results are reported separately. Unless stated, AEs are regarded as unrelated.|12 weeks post last vaccination|Safety population|||Participants|||Count of Participants
2588313|NCT02308540|Primary|Occurrence, Severity and Relatedness of All Adverse Events in Adults and Toddlers|Reported here are only adverse events occurring in 5% or more of subjects; unless specifically stated, AEs were regarded as unrelated.|28 days|All subjects who received at least 1 study vaccination and had at least 1 post vaccination safety measurement and experienced an AE at a rate of 5% or more.|||Participants|||Count of Participants
2588314|NCT02308540|Primary|Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 3|"Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 [none], 1 [mild], 2 [moderate], 3 [severe], 4 [potentially life threatening]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times:~At 60 (± 15) minutes following primary vaccination~Daily by field workers during Days 1 to 6 post vaccination~In the clinic on 7 days (+3) following each vaccination (Visit 2, 4, and 6 for infants)."|7 days|Safety population|||Participants|||Count of Participants
2588469|NCT02307552|Primary|Measure Novel Transurethral Ultrasound Signatures to Detect Prostate Cancer|The primary objective of this Institutional Review Board -controlled study is to determine if Trans urethral ultrasound can be used to identify prostate cancer, thus avoiding prostate needle biopsies for diagnosis|one year|Data were not collected because the study was discontinued due to lack of feasibility and negative results.||||||
2588315|NCT02308540|Primary|Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 2|"Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 [none], 1 [mild], 2 [moderate], 3 [severe], 4 [potentially life threatening]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times:~At 60 (± 15) minutes following primary vaccination~Daily by field workers during Days 1 to 6 post vaccination~In the clinic on 7 days (+3) following each vaccination (Visit 2, 4, and 6 for infants)."|7 days|Safety population|||Participants|||Count of Participants
2588316|NCT02308540|Primary|Infant Subjects Experiencing Local and Systemic Reactogenicity, by Severity: Vaccination 1|"Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 [none], 1 [mild], 2 [moderate], 3 [severe], 4 [potentially life threatening]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times:~At 60 (± 15) minutes following primary vaccination~Daily by field workers during Days 1 to 6 post vaccination~In the clinic on 7 days (+3) following each vaccination (Visit 2, 4, and 6 for infants)."|7 days|Safety population|||Participants|||Count of Participants
2588317|NCT02308540|Primary|Adult and Toddler Subjects Experiencing Local and Systemic Reactogenicity, by Severity|"Local and systemic reactogenicity of the study vaccine was evaluated for severity by toxicity grading scale (0 [none], 1 [mild], 2 [moderate], 3 [severe], 4 [potentially life threatening]) and relatedness to the vaccination. Injection site events were by definition considered related to study vaccine. Reactogenicity was monitored at the following times:~At 60 (± 15) minutes following primary vaccination~Daily by field workers during Days 1 to 6 post vaccination~In the clinic on Day 7 (+3) following each vaccination (Visit 2 for adults and toddlers)."|7 days|All subjects who received at least 1 study vaccination and had at least 1 post vaccination safety measurement.|||Participants|||Count of Participants
2588318|NCT02308475|Secondary|Radiation Dose|Assess the radiation dose (in mGy) delivered with the myocardial perfusion CT comparing the results with those obtained at SPECT.|1 Day|The planned statistical analyses were not performed.||||||
2588319|NCT02308475|Secondary|CTMP/SPECT MPI Disagreement|Evaluate the accuracy of CT myocardial perfusion and SPECT using a stress/rest and delayed enhancement MRI examination as gold-standard by means of Kappa analysis|1 Day|The planned statistical analyses were not performed.||||||
2588320|NCT02308475|Primary|Diagnostic Accuracy of Dynamic Perfusion CT|The diagnostic accuracy of dynamic perfusion CT of the heart for evaluation of perfusion, viability and function during stress and rest will be compared with SPECT myocardial perfusion imaging using p-values for comparison of reader specific values, calculated by means of the McNemar test.|1 Day|The planned statistical analyses were not performed.||||||
2588321|NCT02308371|Secondary|Number of Days in the PICU|Number of days for admission pediatric critical care unit (admission during which subject was enrolled into the study)|From pediatric ICU admission to pediatric ICU discharge (up to 149 days)||||days||Standard Deviation|Mean
2588322|NCT02308371|Secondary|Number of Days on Ventilatory Support|Number of days subject was on ventilatory support (during time of subject enrollment) to the pediatric critical care unit. This included subjects that were intubated or was on a ventilator with a tracheotomy|From pediatric ICU admission to pediatric ICU discharge (up to 149 days)||||days||Standard Deviation|Mean
2588323|NCT02308371|Secondary|Number of Hours on Vasopressors|Hours that a subject remained intubated during pediatric intensive care admission during subject recruitment|From pediatric ICU admission to pediatric ICU discharge (up to 149 days)||||hours||Standard Deviation|Mean
2588324|NCT02308371|Primary|Total Fluid Bolused|Total fluid bolused within 48 hours after enrollment.|48 hours after enrollment||||ml/kg||Standard Deviation|Mean
2588325|NCT02308371|Primary|Total Fluid (ml/kg/Day) Given|Total fluid (ml/kg/day) given during the first 48 hours of enrollment|First 48 hours after enrollment||||ml/kg/day||Standard Deviation|Mean
2588326|NCT02308228|Other Pre-specified|Insulin Sensitivity|A standard OGTT will be used to determine insulin sensitivity using the Matsuda Index.|16 weeks|||||||
2588327|NCT02308228|Other Pre-specified|Percent Change in Total Body Lean Mass by DXA|To determine if metformin improves changes in body composition associated with progressive resistance training. Percent change in total body lean mass in kg was calculated as the difference between week 16 and week 0 from a total body DXA scan.|16 weeks|Analysis of lean muscle mass for those who completed the interventions.|||Percent change||Standard Deviation|Mean
2588328|NCT02308228|Other Pre-specified|Percent Change in Muscle Strength|Determine if metformin treatment augments strength gains in conjunction with progressive resistance training by one repetition maximum assessments. Maximum (1RM) leg extension muscle strength was assessed at week 4 (to account for neurological adaptations during the initial stages of the resistance program) and week 16. The percent change from week 4 to week 16 is reported.|Week 4 and week 16|Some participants were not able to complete the procedure on the day of testing, injured etc|||Percent change||Standard Deviation|Mean
2588329|NCT02308228|Secondary|Percent Change in Normal Density Muscle Size by Computed Tomography|The ability of metformin to improve the hypertrophic response at the whole muscle level will be quantified by computed tomography. Percent change in normal density muscle area will be calculated as the difference between week 16 and week 0.|16 weeks|Missing data points include those who, based on femur area, CT positioning at post measure was incorrect = 16. In addition, 1 subject was excluded from analysis as CT data indicated 45% loss of thigh muscle area, which was not consistent with other data for this subject.|||Percent change||Standard Deviation|Mean
2588330|NCT02308228|Primary|Percent Change in Type 2 Myofiber Cross Sectional Area|The ability of metformin to improve the hypertrophic response to resistance training will be determined. Muscle biopsies of the vastus lateralis will be used to quantify myofiber cross-sectional area. The percent change in type 2 myofiber size between week 16 and week 0 was used.|16 weeks|The largest, highest quality pairs of baseline and week 16 mounts were used for quantification of immunohistochemistry (N=30/group)|||Percent change||Standard Deviation|Mean
2588331|NCT02308189|Secondary|Muscle Endurance (Time to Task Failure) % of Change|Time for successfully performing a sustained, submaximal muscle contraction|Baseline and following 10-weeks of exercise training. Values are calculated on % of change.|Study participants completing study.|||percentage of change from baseline||Standard Deviation|Mean
2588333|NCT02308189|Primary|Trunk Extensor Muscle Cross Sectional Area % of Change|The primary endpoint is percent change in trunk extensor muscle cross-sectional area measured by The primary endpoint is percent change in trunk extensor muscle cross-sectional area measured by MRI at week 10 (study day 70) after start of exercise training.|Baseline and following 10-weeks of exercise training. Values are calculated from % change.|Per protocol analysis of completed study participants|||percentage of change||Standard Deviation|Mean
2588334|NCT02308163|Secondary|Number of Participants With Adverse Events From Week 12|Treatment-emergent adverse events (TEAEs) were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.|Week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study|SAF|||Participants|||Count of Participants
2588335|NCT02308163|Secondary|Number of Participants With Adverse Events During the First 12 Weeks|Treatment-emergent adverse events (TEAEs) were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by System Organ Class (SOC) and Preferred Term (PT). Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.|Week 0 to Week 12|SAF|||Participants|||Count of Participants
2588336|NCT02308163|Secondary|Change From Baseline in WPAI Percent Activity Impairment Through Week 52|WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent activity impairment due to problem: Q6/10.|Baseline and Week 4, 8, 12, 28, and 52|FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the WPAI questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.|||percent impairment||Standard Deviation|Mean
2588337|NCT02308163|Secondary|Change From Baseline in WPAI Percent Activity Impairment at Week 12|WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent activity impairment due to problem: Q6/10.|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Percent Impairment||Standard Deviation|Mean
2588338|NCT02308163|Secondary|Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52|WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent overall work impairment due to problem: Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)].|Baseline and Week 4, 8, 12, 28, and 52|FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the WPAI questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.|||Percent Impairment||Standard Deviation|Mean
2588339|NCT02308163|Secondary|Change From Baseline in Percent Overall Work Impairment at Week 12|WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent overall work impairment due to problem: Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)].|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Percent iImpairment||Standard Deviation|Mean
2588340|NCT02308163|Secondary|Change From Baseline in WPAI Percent Impairment While Working Through Week 52|WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10.|Baseline and Week 4, 8, 12, 28, and 52|FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the WPAI questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.|||percent impairment||Standard Deviation|Mean
2588361|NCT02308163|Secondary|Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52|"CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description.~CDAI = TJC + SJC + SGA + PGA. CDAI. Remission was defined as CDAI score ≤ 2.8."|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Percentage of Participants|||Number
2588341|NCT02308163|Secondary|Change From Baseline in WPAI Percent Impairment While Working at Week 12|WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10.|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Percent Impairment||Standard Deviation|Mean
2588342|NCT02308163|Secondary|Change From Baseline in WPAI Percent Work Time Missed Through Week 52|WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4).|Baseline and Week 4, 8, 12, 28, and 52|FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the WPAI questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.|||Percent Work Time||Standard Deviation|Mean
2588343|NCT02308163|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12|WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4).|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Percent Work Time||Standard Deviation|Mean
2588344|NCT02308163|Secondary|Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52|The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.|Baseline and Week 4, 8, 12, 28, and 52|FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the SF-36 questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.|||Units on a Scale||Standard Deviation|Mean
2588345|NCT02308163|Secondary|Change From Baseline in SF-36v2 Role/Social Component Summary Score at Week 12|The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Units on a Scale||Standard Deviation|Mean
2588346|NCT02308163|Secondary|Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52|The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.|Baseline and Week 4, 8, 12, 28, and 52|FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the SF-36 questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.|||units on a scale||Standard Deviation|Mean
2588347|NCT02308163|Secondary|Change From Baseline in SF-36v2 Mental Component Summary Score at Week 12|The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Units on a Scale||Standard Deviation|Mean
2588362|NCT02308163|Secondary|Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Score <= 2.8 at Week 12|"CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description.~CDAI = TJC + SJC + SGA + PGA. CDAI. Remission was defined as CDAI score ≤ 2.8. Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups."|Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Percentage of Participants|||Number
2590386|NCT02284464|Secondary|Renal Function|Renal function after kidney transplant in both groups at 24 months measured according to the creatinine (mg/dL) concentrations|24 months||||mg/dl||Standard Deviation|Mean
2588348|NCT02308163|Secondary|Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52|The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.|Baseline and Week 4, 8, 12, 28, and 52|FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the SF-36 questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib.|||Units on a Scale||Standard Deviation|Mean
2588349|NCT02308163|Secondary|Change From Baseline in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score at Week 12|The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Units on a Scale||Standard Deviation|Mean
2588350|NCT02308163|Secondary|Change From Baseline in HAQ-DI Through Week 52|The HAQ-DI (range 0 - 3) was composed of 20 items in 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities). Each category has at least two questions. Within each category, participants reported the amount of difficulty they have in performing the specific question items. Higher HAQ-DI score indicates greater disease activity.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||units on a scale||Standard Deviation|Mean
2588351|NCT02308163|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12|The HAQ-DI (range 0 - 3) was composed of 20 items in 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities). Each category has at least two questions. Within each category, participants reported the amount of difficulty they have in performing the specific question items. Higher HAQ-DI score indicates greater disease activity.|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Units on a Scale||Standard Deviation|Mean
2588352|NCT02308163|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy|The number of participants who withdrew due to lack of efficacy up to week 12 was calculated.|Up to week 12|Initial Randomization Set|||Participants|||Count of Participants
2588353|NCT02308163|Secondary|Change From Baseline in Subject's Assessment of Pain Through Week 52|The participant assessed his/her own pain severity on a VAS from 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicate greater activity pain.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Units on a Scale||Standard Deviation|Mean
2588354|NCT02308163|Secondary|Change From Baseline in Subject's Assessment of Pain at Week 12|The participant assessed his/her own pain severity on a VAS from 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicate greater activity pain.|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Units on a Scale||Standard Deviation|Mean
2588355|NCT02308163|Secondary|Change From Baseline in SGA Through Week 52|The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||units on a scale||Standard Deviation|Mean
2588356|NCT02308163|Secondary|Change From Baseline in Subject's SGA at Week 12|The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment.|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Units on a Scale||Standard Deviation|Mean
2588357|NCT02308163|Secondary|Change From Baseline in PGA Through Week 52|The investigator assessed the participants' disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||units on a scale||Standard Deviation|Mean
2588358|NCT02308163|Secondary|Change From Baseline in Physician's Global Assessment of Arthritis (PGA) at Week 12|The investigator assessed the participants' disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment.|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Units on a Scale||Standard Deviation|Mean
2588359|NCT02308163|Secondary|Change From Baseline in CDAI Score Through Week 52|"CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description.~CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Units on a Scale||Standard Deviation|Mean
2588360|NCT02308163|Secondary|Change From Baseline in CDAI Score at Week 12|"CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description.~CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity."|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Units on a Scale||Standard Deviation|Mean
2590387|NCT02284464|Secondary|Blood Pressure|Blood pressure after kidney transplant in both groups at 24 months|24 months||||mmHg||Standard Deviation|Mean
2588363|NCT02308163|Secondary|Change From Baseline in SDAI Score Through Week 52|"SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description.~SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Units on a Scale||Standard Deviation|Mean
2588364|NCT02308163|Secondary|Change From Baseline in SDAI Score at Week 12|"SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description.~SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity."|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Units on a Scale||Standard Deviation|Mean
2588365|NCT02308163|Secondary|Percentage of Participants Achieving SDAI Remission Through Week 52|"SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description.~SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3."|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Percentage of Participants|||Number
2588366|NCT02308163|Secondary|Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission at Week 12|"SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description.~SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3.~Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups."|Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Percentage of Participants|||Number
2588367|NCT02308163|Secondary|Percentage of Participants Achieving ACR / EULAR Remission Through Week 52|ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤ 1, CRP ≤ 1 mg/dL, and subject's global assessment of arthritis ≤ 1 cm (on a VAS of 0 - 100 mm).|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Percentage of Participants|||Number
2588368|NCT02308163|Secondary|Percentage of Participants Achieving ACR / EULAR Remission at Week 12|"ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤ 1, CRP ≤ 1 mg/dL, and subject's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm).~Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups."|Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Percentage of Participants|||Number
2588369|NCT02308163|Secondary|Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52|Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline > 0.6, or DAS28 after treatment > 5.1 and improvement from baseline > 1.2.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Percentage of Participants|||Number
2588370|NCT02308163|Secondary|Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR at Week 12|Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline > 0.6, or DAS28 after treatment > 5.1 and improvement from baseline > 1.2.|Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Percentage of Participants|||Number
2588371|NCT02308163|Secondary|Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52|Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Percentage of Participants|||Number
2588372|NCT02308163|Secondary|Percentage of Participants With a Good EULAR Response Using DAS28-ESR at Week 12|Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2.|Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Percentage of Participants|||Number
2588373|NCT02308163|Secondary|Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52|Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline > 0.6, or DAS28 after treatment > 5.1 and improvement from baseline > 1.2.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Percentage of Participants|||Number
2588374|NCT02308163|Secondary|Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12|Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline > 0.6, or DAS28 after treatment > 5.1 and improvement from baseline > 1.2.|Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Percentage of Participants|||Number
2588375|NCT02308163|Secondary|Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52|Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Percentage of Participants|||Number
2588376|NCT02308163|Secondary|Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12|Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2.|Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Percentage of Participants|||Number
2588377|NCT02308163|Secondary|Change From Baseline in ESR Through Week 52|Higher ESR indicates greater disease activity.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||mm/hour||Standard Deviation|Mean
2588378|NCT02308163|Secondary|Change From Baseline in ESR at Week 12|Higher ESR indicates greater disease activity.|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||mm/hour||Standard Deviation|Mean
2590388|NCT02284464|Secondary|Lipid Profile|Lipid profile after kidney transplant in both groups at 24 months|24 months||||mg/dl||Standard Deviation|Mean
2588381|NCT02308163|Secondary|Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52|"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity."|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Percentage of Participants|||Number
2588382|NCT02308163|Secondary|Percentage of Participants Achieving DAS28-ESR <= 3.2 at Week 12|"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity."|Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Percentage of Participants|||Number
2588383|NCT02308163|Secondary|Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52|"DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity."|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Percentage of Participants|||Number
2588384|NCT02308163|Secondary|Percentage of Participants Achieving DAS28-CRP <= 3.2 at Week 12|"DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity."|Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Percentage of Participants|||Number
2588385|NCT02308163|Secondary|Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52|"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission."|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Percentage of Participants|||Number
2588386|NCT02308163|Secondary|Percentage of Participants Achieving DAS28-ESR < 2.6 at Week 12|"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission."|Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Percentage of Participants|||Number
2588387|NCT02308163|Secondary|Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52|"DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission."|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Percentage of Participants|||Number
2588388|NCT02308163|Secondary|Percentage of Participants Achieving DAS28-CRP < 2.6 at Week 12|"DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission."|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Percentage of Participants|||Number
2588389|NCT02308163|Secondary|Change From Baseline in SJC (66 Joints) Through Week 52|"The following 66 joints subjects to assessment were examined for swollen joints and the location was confirmed. Higher SJC66 indicated greater disease activity.~Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8)."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Swollen Joints||Standard Deviation|Mean
2588390|NCT02308163|Secondary|Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Week 12|"The following 66 joints subjects to assessment were examined for swollen joints and the location was confirmed. Higher SJC66 indicated greater disease activity.~Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8)."|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Tender Joints||Standard Deviation|Mean
2588391|NCT02308163|Secondary|Change From Baseline in TJC (68 Joints) Through Week 52|"The following 68 joints subjects to assessment were examined for tender joints and the location was confirmed. Higher TJC68 indicated greater disease activity.~Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8)."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Tender Joints||Standard Deviation|Mean
2588392|NCT02308163|Secondary|Change From Baseline in TJC (68 Joints) at Week 12|"The following 68 joints subjects to assessment were examined for tender joints and the location was confirmed. Higher TJC68 indicated greater disease activity.~Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8)."|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Tender Joints||Standard Deviation|Mean
2588393|NCT02308163|Secondary|Change From Baseline in DAS28-ESR Through Week 52|"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Units on a Scale||Standard Deviation|Mean
2588394|NCT02308163|Secondary|Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (ESR) at Week 12|"DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity."|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Units on a Scale||Standard Deviation|Mean
2588395|NCT02308163|Secondary|Change From Baseline DAS28-CRP Through Week 52|DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Units on a Scale||Standard Deviation|Mean
2588396|NCT02308163|Secondary|Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12|"DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description.~DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity."|Baseline and Week 12/ET|FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used.|||Units on a Scale||Standard Deviation|Mean
2588397|NCT02308163|Secondary|Percentage of Participants With an ACR70-CRP Response Through Week 52|"The ACR70 response required that all criteria from (1) to (3) below be met.~TJC : ≥ 70% reduction compared with baseline.~SJC : ≥ 70% reduction compared with baseline.~≥ 70% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Percentage of Participants|||Number
2588398|NCT02308163|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70)-CRP Response at Week 12|"The ACR70 response required that all criteria from (1) to (3) below be met.~TJC : ≥ 70% reduction compared with baseline.~SJC : ≥ 70% reduction compared with baseline.~≥ 70% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP."|Baseline and Week 12/ET|FAS. LOCF was used.|||Percentage of Participants|||Number
2588399|NCT02308163|Secondary|Percentage of Participants With an ACR50-CRP Response Through Week 52|"The ACR50 response required that all criteria from (1) to (3) below be met.~TJC : ≥ 50% reduction compared with baseline.~SJC : ≥ 50% reduction compared with baseline.~≥ 50% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Percentage of Participants|||Number
2588400|NCT02308163|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50)-CRP Response at Week 12|"The ACR50 response required that all criteria from (1) to (3) below be met.~TJC : ≥ 50% reduction compared with baseline.~SJC : ≥ 50% reduction compared with baseline.~≥ 50% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP."|Baseline and Week 12/ET|FAS. LOCF was used.|||Percentage of Participants|||Number
2588401|NCT02308163|Secondary|Percentage of Participants With an ACR20-CRP Response Through Week 52|"The ACR20 response required that all criteria from (1) to (3) below be met.~TJC : ≥ 20% reduction compared with baseline.~SJC : ≥ 20% reduction compared with baseline.~≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP."|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS, number of participants with available data at each study visit.|||Percentage of Participants|||Number
2588402|NCT02308163|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12|"The ACR20 response required that all criteria from (1) to (3) below be met.~Tender joint count (TJC) : ≥ 20% reduction compared with baseline.~Swollen joint count (SJC) : ≥ 20% reduction compared with baseline.~≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline~(3) ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, Subject's Global Assessment of Arthritis (SGA), Physician's Global Assessment of Arthritis (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), C-Reactive Protein (CRP)."|Baseline and Week 12/early termination (ET)|The analysis population consisted of the Full Analysis Set (FAS). Last observation carried forward (LOCF) was used.|||Percentage of Participants|||Number
2588449|NCT02307682|Secondary|Average Change From Baseline in CSFTtot Over the Period Week 84 Through Week 96 - Study Eye|CSFTtot (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.|Baseline, Weeks 84, 88, 92, 96|FAS - LOCF|||micrometers||Standard Deviation|Mean
2588403|NCT02308124|Secondary|Changes in Health-related Quality of Life|"changes in Short Form (36) Health Survey version 2 (SF-36v2) mental component summary scale (MCS)~SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores."|changes at 3 months after treatment|At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)|||points||Standard Deviation|Mean
2588404|NCT02308124|Secondary|Changes in Health-related Quality of Life|"changes in Short Form (36) Health Survey version 2 (SF-36v2) physical component summary scale (PCS) compared to the baseline~SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores."|changes at 3 months after treatment|At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)|||points||Standard Deviation|Mean
2588405|NCT02308124|Secondary|Change of the Depression Score (Beck Depression Inventory-II )|"Change of the depression score after 3-month medical treatment compared to initial results.~21 multiple-choice questions, each of which can be scored from 0 to 3. Higher score represent higher degree of depression.~Score Normal; 0-13, Mild depression; 14-19, Moderate depression; 20-28, Severe depression; 29-63"|after 3-month medical treatment.|At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)|||points||Standard Deviation|Mean
2588406|NCT02308124|Secondary|Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ)).|"Change of the OH associated symptom survey result after 3-month medical treatment compared to initial results.~OHQ questionnaire has two components: the OH daily activity scale (OHDAS), which contains 4 items measuring the impact of OH on daily activities, and the OH symptom assessment (OHSA), which contains 6 items measuring the symptoms of OH (dizziness/light headedness, vision disturbance, weakness, fatigue, trouble concentrating, and head/neck discomfort).This questionnaire reflects the severity of OH-related symptoms on a 10-point scale, with 0 indicating the absence of a symptom and 10 indicating maximal severity.~** OHQ total score minimal 0 ~ maximal 100"|after 3-month medical treatment.|At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)|||points||Standard Deviation|Mean
2588407|NCT02308124|Primary|Change in Orthostatic BP Drop|Change of orthostatic SBP and DBP drop after 3-month medical treatment compared to initial results.|after 3-month medical treatment|At 3 months after treatment, 65 patients were evaluated (Midodrine only; 23, Pyridostigmine only; 21, Midodrine + Pyridostigmine; 21). 22 additional patients missed visit (Midodrine only; 6, Pyridostigmine only; 8, Midodrine + Pyridostigmine; 8)|||mmHg||Standard Deviation|Mean
2588408|NCT02308020|Secondary|Pharmacokinetics (PK): Steady State Minimum Concentration (Cmin) of Abemaciclib and Its Metabolites LSN2839567 (M2), LSN3106726 (M20), and LSN3106729 (M18)|A PK plasma sample was taken prior to abemaciclib dose to analyze the minimum concentrations of abemaciclib and its metabolites (Cmin) - Individual Cmin values were averaged if there were 3 or more available data points, otherwise individual data are reported.|Parts A, B, D, E, F, Cycle 3, Day 1: Predose; Part C, Cycle 4, Day 1: Predose|All participants who had evaluable PK data.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2588409|NCT02308020|Secondary|Change From Baseline in Neurologic Symptoms on the MD Anderson Inventory-Brain Tumor (MDASI-BT) Subscale|"The MDASI-BT is an instrument to assess multi-symptoms in participants with brain tumor metastases (including those with brain metastases secondary to breast cancer). The MDASI-BT of participants with a change from baseline is reported as mean core symptoms, mean brain tumor symptoms, and symptom groupings (mean focal neurologic deficit, mean generalized/disease status symptoms, and mean gastrointestinal symptoms). The mean of all symptom subscale items was calculated where 0 equals not present and 10 equals as bad as you can imagine. A change from baseline with negative values indicate improvement, positive values indicate worsening."|Baseline, Cycle 3 (Up to 63 Days)|All participants who received at least one dose of study drug and had at least 1 baseline and an evaluable post baseline assessment. Parts C and F were exploratory per protocol.|||units on a scale||Standard Deviation|Mean
2588410|NCT02308020|Secondary|Progression Free Survival (PFS) Bi-compartmental|PFS was measured from baseline to objective progression (intracranial or extracranial) as defined by (RANO-BM.) or death from any cause. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment. PD is greater than or equal to (≥) 20% increase in sum LD relative to nadir and a relative increase of 20%, ≥1 lesion must increase by absolute value of ≥5 mm. PFS was summarized using Kaplan-Meier estimates.|Baseline to Objective Disease Progression or Death from Any Cause (Up to 36 Months)|All participants who had evaluable OIRR data with at least one measurable brain lesion at baseline (per RANO-BM) and for whom at least one post-baseline overall response assessment. Censored participants Part A = 0, Part B =4, Part D = 0 and Part E = 1. Parts C and F were exploratory per protocol.|||Months||95% Confidence Interval|Median
2588437|NCT02307682|Secondary|Percentage of Subjects With Intraretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye|Intraretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal hemorrhage is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. Hypothesis testing not pre-specified.|Baseline, Weeks 12, 48, 96|FAS with non-missing values. Number analyzed is the number of subjects with a value for both baseline and the specific post-baseline visit.|||percentage of subjects|||Number
2588411|NCT02308020|Secondary|Percentage of Participants With a Best Overall Response of CR, PR, or SD: Extracranial Disease Control Rate (EDCR)|Disease control rate (DCR) (CR+ PR+ SD) per RECIST v1.1. is defined as the percentage of participants with best overall response of CR, PR, or SD. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. PD is defined as at least a 20% increase in the sum LD of CNS target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) and the 20% increase must be at least one lesion must increase by an absolute value of ≥5 mm to be considered progression.|Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 36 Months)|All participants who received at least one dose of study drug and had evaluable extracranial disease data. Parts C and F were exploratory per protocol.|||percentage of participants|||Number
2588412|NCT02308020|Secondary|Percentage of Participants With a Best Response of CR or PR: Extracranial Objective Response Rate (EORR)|The percentage of participants with a best response of CR or PR objective response rate is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. PD is defined as at least a 20% increase in the sum LD of CNS target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) and the 20% increase must be at least one lesion must increase by an absolute value of ≥5 mm to be considered progression.|Baseline to Disease Progression (Up to 36 Months)|All participants who received at least one dose of study drug and had evaluable extracranial disease data. Parts C and F were exploratory per protocol.|||percentage of participants|||Number
2588413|NCT02308020|Secondary|Overall Survival (OS)|OS was measured from baseline to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for a particular analysis, OS was censored for that analysis at the date of last contact prior to the data inclusion cutoff date (contacts considered in the determination of last contact date include adverse event (AE) date, tumor assessment date, visit date, and last known alive date). OS was summarized using Kaplan-Meier estimates.|Baseline to the Date of Death from Any Cause (Approximately Up to 5 Years)||2020-01-31|01/2020||||
2588414|NCT02308020|Secondary|Percentage of Participants With BOIR of CR, PR, or SD With Duration of SD for at Least 6 Months: Intracranial Clinical Benefit Rate (ICBR)|ICBR is the percentage of participants with BOIR of CR, PR, or SD with duration of SD for at least 6 months, as defined by RANO-BM. CR is measurable target lesions, the disappearance of all CNS target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum LD of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. SD is <30% decrease relative to baseline but <20% increase in sum LD relative to nadir. PD is greater than or equal to (≥) 20% increase in sum LD relative to nadir and a relative increase of 20%, ≥1 lesion must increase by absolute value of ≥5 mm.|Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 36 Months)|All participants who had evaluable OIRR data with at least one measurable brain lesion at baseline (per RANO-BM) and for whom at least one post-baseline overall response assessment for intracranial disease is available. Parts C and F were exploratory per protocol.|||percentage of participants|||Number
2588415|NCT02308020|Secondary|Percentage of Participants With Best Overall Intracranial Response (BOIR) of CR, PR, or SD: Intracranial Disease Control Rate (IDCR)|Percentage of participants with BOIR of CR, PR, or SD: IDCR, as defined by RANO-BM is reported. CR is measurable target lesions, the disappearance of all central nervous system CNS target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum LD of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Nontarget lesions requires disappearance CNS non-target lesions and no new CNS lesions. SD is less than (<)30% decrease relative to baseline but <20% increase in sum LD relative to nadir. PD is greater than or equal to (≥) 20% increase in sum LD relative to nadir and a relative increase of 20%, ≥1 lesion must increase by absolute value of ≥5 mm.|Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 36 Months)|All participants who had evaluable OIRR data with at least one measurable brain lesion at baseline (per RANO-BM) and for whom at least one post-baseline overall response assessment. Parts C and F were exploratory per protocol.|||percentage of participants|||Number
2588416|NCT02308020|Secondary|Duration of CR or PR: Duration of Intracranial Response (DOIR)|DOIR is measured from the date of first evidence of a confirmed response (CR or PR), as defined by RANO-BM, to the date objective progression or death from any cause. CR is measurable target lesions, the disappearance of all CNS target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum LD of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Participants who have neither progressed nor died were censored on the day of their last radiographic tumor assessment or on the date of response. PD is greater than or equal to (≥) 20% increase in sum LD relative to nadir and a relative increase of 20%, ≥1 lesion must increase by absolute value of ≥5 mm. DOIR was summarized using Kaplan-Meier estimates.|Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Up to 36 Months)|All participants who had a confirmed intracranial response of CR or PR (per RANO-BM) and for whom at least one post-baseline overall intracranial response with a measurable duration is available. Parts C and F were exploratory per protocol.|||Months||Full Range|Median
2588435|NCT02307838|Primary|Change From Baseline (BL) in Expanded Disability Status Scale (EDSS)|EDSS is a scale for assessing neurologic impairment in MS. It consists of eight functional systems (FS) which are used to derive the EDSS steps (score) ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's score is determined between 0 to 10. A negative change from baseline indicates improvement.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||score on a scale||Standard Error|Least Squares Mean
2588417|NCT02308020|Secondary|Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD), or Not Evaluable (NE): Best Overall Intracranial Response (BOIR)|Percentage of Participants with BOIR was categorized as CR, PR, SD, PD or NE, as defined by RANO-BM, from baseline until the earliest of objective progression according to brain metastases response criteria or start of new anticancer therapy. CR is measurable target lesions, the disappearance of all CNS target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum LD of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. SD is <30% decrease relative to baseline but <20% increase in sum LD relative to nadir. PD is greater than or equal to (≥) 20% increase in sum LD relative to nadir and a relative increase of 20%, ≥1 lesion must increase by absolute value of ≥5 mm. NE is absent (no abnormality; normal), or non-evaluable (NE).|Baseline to Earliest Objective Progression or Start of New Anticancer Therapy (Up to 36 Months)|All participants who had evaluable OIRR data with at least one measurable brain lesion at baseline (per RANO-BM) and for whom at least one post-baseline overall response assessment for intracranial disease is available. Parts C and F were exploratory per protocol.|||percentage of participants|||Number
2588418|NCT02308020|Primary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR): Objective Intracranial Response Rate (OIRR)|OIRR is the percentage of participants with a (CR) or (PR) based on the Response Assessment in Neuro-Oncology Brain Metastasis (RANO-BM) response criteria. CR is measurable target lesions, the disappearance of all central nervous system (CNS) target lesions for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically. PR is at least a 30% decrease in the sum longest duration (LD) of CNS target lesions, taking as reference the baseline sum LD for at least 4 weeks; no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Nontarget lesions requires disappearance CNS non-target lesions and no new CNS lesions. Stable disease (SD) is less than (<)30% decrease relative to baseline but <20% increase in sum LD relative to nadir. Progressive disease (PD) is greater than or equal to (≥) 20% increase in sum LD relative to nadir and a relative increase of 20%, ≥1 lesion must increase by absolute value of ≥5 millimeter (mm).|Baseline to Objective Disease Progression (Up to 36 Months)|All participants who had evaluable OIRR data with at least one measurable brain lesion at baseline (per RANO-BM) and for whom at least one post-baseline overall response assessment for intracranial disease is available. Parts C and F were exploratory per protocol.|||percentage of participants|||Number
2588419|NCT02307838|Secondary|Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters|The correlation between FTY treatment duration and disability progression outcomes was assessed. The number presented in the table is the Pearson correlation coefficient, r.|10 years|The FAS was considered for the analysis. Only participants who had 10 year correlation measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.|||Pearson correlation coeffcient|||Number
2588420|NCT02307838|Secondary|Percentage Brain Volume Change (PBVC)|PVBC was assessed by MRI. A negative change from baseline indicates improvement.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The FAS was considered for the analysis. Only participants with both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.|||Percent change||Standard Deviation|Mean
2588421|NCT02307838|Secondary|Change From Baseline in Third Ventricle Diameter|Third ventricle diameter was assessed by MRI. A negative change from baseline indicates improvement.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The FAS was considered for analysis. Only participants who had both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.|||mm||Standard Deviation|Mean
2588422|NCT02307838|Secondary|Third Ventricle Diameter|Third ventricle diameter was assessed by MRI.|10 years|The FAS was considered for the analysis. Only participants with 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.|||mm||Standard Deviation|Mean
2588423|NCT02307838|Secondary|Change From Baseline in Total Volume of T2 Lesion|Total volume in T2 lesion was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The FAS was considered for the analysis. Only participants from the FAS who had both baseline and 10 years measurements were included in the analysis. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.|||mm^3||Standard Deviation|Mean
2588424|NCT02307838|Secondary|Total Volume in T2 Lesion|Total volume in T2 lesion was assessed by magnetic resonance imaging (MRI).|10 years|The FAS was considered for the analysis. Only participants with measurements at 10 years were included in the analysis. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.|||mm^3||Standard Deviation|Mean
2588425|NCT02307838|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z Score|MSFC is a composite measure encompassing information from the nine-hole peg test (arm dimension), timed 25 foot walk (leg dimension) and PASAT. The MSFC composite Z score was calculated as follows: (1) the average scores from the four trials on the 9-HPT (the two trials for each hand were averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals were averaged); (2) the average scores of two 25-Foot Timed Walk trials; (3) the number correct from the PASAT-3. The MSFC is based on the concept that scores for these three dimensions—arm, leg, and cognitive function are combined to create a single score (the MSFC) that can be used to detect change over time in a group of multiple sclerosis patients. This was done by creating Z-scores for each component of the MSFC, and averaging them to create an overall composite Z score.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The FAS was considered for the analysis. Only participants with both baseline measurements for each MSFC component and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or MRI within study FTY720D2201.|||Z score||Standard Deviation|Mean
2588426|NCT02307838|Secondary|Change From Baseline in MSFC Component: Timed 25-foot Walk Test Score|The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The patient is directed to one end of a clearly marked 25-foot (7.62 m) course and is instructed to walk 25 feet (7.62 meter) as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The test scores were the time in seconds it took to walk the 25 feet. A negative change from baseline indicates improvement.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The FAS was considered for the analysis. Only participants with both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||score on a scale||Standard Deviation|Mean
2588427|NCT02307838|Secondary|Change From Baseline in MSFC Component: Paced Auditory Serial Addition Test (PASAT) Score|The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is the last measure administered at each visit. It is presented on audio compact disc (CD) to control the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The test result is the number of correct sums given (out of 60 possible). A positive change from baseline indicates improvement.|baseline from core study (CFTY720D2201 (NCT00333138)), 10 years|The FAS was considered for the analysis. Only participants with both baseline and 10 year measurements were analyzed. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||score on a scale||Standard Deviation|Mean
2588428|NCT02307838|Secondary|Change From Baseline in Multiple Sclerosis Fuctional Composite (MSFC) Component: Nine Hole Peg Test (9-HPT)|The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Both the dominant and non-dominant hands are tested twice (two consecutive trials of the dominant hand, followed immediately by two consecutive trials of the non-dominant hand). The time limit per trial is 300 seconds. The right and left hand scores were the time in seconds it took to insert and remove 9 pegs ((the average scores from the four trials on the 9-HPT (the two trials for each hand are averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals are averaged)). A negative change from baseline indicates improvement.|baseline from core study, CFTY720D2201 (NCT00333138), 10 years|The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||seconds||Standard Deviation|Mean
2588429|NCT02307838|Secondary|Percentage of Participants With First Use of a Wheelchair|First use of a wheelchair was considered from EDSS 7.0 for participants having started FTY720D2201 (NCT00333138) with an EDSS score below 7.0.|10 years|The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||Percentage of participants|||Number
2588430|NCT02307838|Secondary|Percentage of Participants With First Use of an Ambulatory Device|First use of an ambulatory device was considered from EDSS 6.0 for participants having started FTY720D2201 (NCT00333138) with an EDSS score below 6.0.|10 years|The FAS was considered for the analysis. Only participants with evaluable data were included in the analysis. The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||Percentage of participants|||Number
2588431|NCT02307838|Secondary|Number of Participants Classified as Secondary Progressive MS (SPMS)|SPMS follows an initial relapsing-remitting course. Most people who are diagnosed with relapsing-remitting multiple sclerosis (RRMS) will eventually transition to a secondary progressive course in which there is a progressive worsening of neurologic function (accumulation of disability) over time. Participants who were classified as SPMS were assessed.|10 years|The full analysis set (FAS) included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||Participants|||Number
2588432|NCT02307838|Secondary|Number of Participants Not Using a Wheelchair or Being Bedridden|The number of participants not using a wheelchair or being bedridden was assessed.|10 years|The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||Participants|||Number
2588433|NCT02307838|Secondary|Number of Participants With EDSS <4 or <6|EDSS is a scale for assessing neurologic impairment in MS. It consists of eight functional systems (FS) which are used to derive the EDSS steps (score) ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's score is determined between 0 to 10. A positive change from baseline indicates improvement.|10 years|The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||Participants|||Number
2588434|NCT02307838|Secondary|Number of Participants With Disability Progression|Disability progression is defined as: 1.5-point increase from baseline in participants with baseline EDSS score = 0.0; OR 1-point increase in EDSS from baseline in participants with baseline EDSS score of 1.0 to 5.0 inclusive; OR 0.5-point increase in EDSS from baseline in participants with baseline EDSS score >5.0.|10 Years|The FAS included all participants who received at least one dose of study drug during FTY720D2201 and had at least one pre-treatment assessment in EDSS or magnetic resonance imaging (MRI) within study FTY720D2201.|||Participants|||Number
2588436|NCT02307682|Secondary|Percentage of Subjects With Subretinal Hemorrhage (Central Subfield) Present at the Visit While Absent at Baseline at Each Treatment - Study Eye|Subretinal hemorrhage was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal hemorrhage is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. Hypothesis testing not pre-specified.|Baseline, Weeks 12, 48, 96|FAS with non-missing values. Number analyzed is the number of subjects with a value for both baseline and the specific post-baseline visit.|||percentage of subjects|||Number
2588438|NCT02307682|Secondary|Percentage of Subjects With Induced or Boosted Anti-drug Antibody (ADA) Status at Week 48 (Brolucizumab Only)|Serum samples were collected and assessed for anti-drug antibody status. Subjects were categorized as ADA negative when one of the following was met: ADA negative at all time points (predose and postdose); ADA negative at predose and no titer values above 10 at all other time points; or ADA titer of 10 at predose but negative at all other time points. ADA induced was defined as ADA negative at predose with postdose titer value greater than or equal to a titer of 30 at any timepoint. ADA boosted was defined as ADA positive at predose with postdose titer values that increased by at least two dilutions (9-fold) from their respective predose value at any time point. Hypothesis testing not pre-specified.|Week 48|Safety Analysis Set - Observed. All randomized subjects who received at least 1 intravitreal injection.|||percentage of subjects|||Number
2588439|NCT02307682|Secondary|Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Score at Week 24, Week 48, Week 72, and Week 96|The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) is a validated questionnaire that collects 25 vision-targeted responses from age-related macular degeneration (AMD) subjects. The 25 questions pertain to global vision rating (1), difficulty with near vision activities (3), difficulty with distance vision activities (3), limitations in social functioning due to vision (2), role limitations due to vision (2), dependency on others due to vision (3), mental health symptoms due to vision (4), driving difficulties (3), limitations with peripheral (1) and color vision (1), and ocular pain (2). Each response is converted to a 0 to 100 sub-scale, with the lowest and highest possible scores set at 0 and 100 points, respectively. The overall composite score (0 to 100) is obtained by averaging the 25 sub-scale scores. A high score represents better functioning.|Baseline, Weeks 24, 48, 72, 96|FAS - Observed. Number analyzed is the number of subjects with a value for both baseline and the specific post-baseline visit.|||score on a scale||Standard Deviation|Median
2588440|NCT02307682|Secondary|"Percentage of Subjects With Disease Activity Present (q8 Treatment Need = Yes) at Week 16 - Study Eye"|A disease activity assessment (DAA) was performed to identify q8 treatment need. 95% CI for binomial proportions is based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Week 16|FAS - ‘efficacy/safety’ approach. Censored data attributable to lack of efficacy and/or safety are imputed with q8w need = Yes at the next disease activity assessment visit.|||percentage of subjects||95% Confidence Interval|Number
2588441|NCT02307682|Secondary|Number of Subjects With Subretinal Fluid (SRF) and/or Intraretinal Fluid (IRF) Present Between Week 36 to Week 48, Reported by Number of Visits|Subretinal fluid and intraretinal fluid were assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal and/or intraretinal fluid is an indicator of underlying disease. One eye (study eye) contributed to the analysis. For each subject, the number of visits with SRF and/or IRF fluid is analyzed.|Weeks 36, 40, 44, 48|FAS - LOCF|||subjects|||Number
2588442|NCT02307682|Secondary|Percentage of Subjects With Presence of Subretinal and/or Intraretinal Fluid at Each Post-baseline Visit - Study Eye|Subretinal fluid and intraretinal fluid were assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal and/or intraretinal fluid is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2588443|NCT02307682|Secondary|Percentage of Subjects With Presence of Sub-retinal Pigment Epithelium (RPE) Fluid at Each Post-baseline Visit - Study Eye|Sub-RPE fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of sub-RPE fluid is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2588444|NCT02307682|Secondary|Percentage of Subjects With Presence of Intraretinal Fluid at Each Post-baseline Visit - Study Eye|Intraretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal fluid is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2588445|NCT02307682|Secondary|Percentage of Subjects With Presence of Subretinal Fluid at Each Post-baseline Visit - Study Eye|Subretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of subretinal fluid is an indicator of underlying disease. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2588446|NCT02307682|Secondary|Change From Baseline in Central Subfield Neurosensory Retinal Thickness (CSFTns) at Each Post-baseline Visit - Study Eye|Central subfield neurosensory retinal thickness was assessed using SD-OCT. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||micrometers||Standard Deviation|Mean
2588447|NCT02307682|Secondary|Change From Baseline in Choroidal Neovascularization (CNV) Lesion Size at Week 12, Week 48, and Week 96 - Study Eye|CNV lesion size (the area of new blood vessels in the choroid layer of the retina) size was measured using fluorescein angiography (FA). A negative change value indicates a reduction in lesion size, whereas a positive change value indicates an increase. An increase in CNV lesion size may indicate progression of the underlying disease. Only one eye (study eye) contributed to the analysis.|Baseline, Weeks 12, 48, 96|FAS - LOCF. Number analyzed is the number of subjects with a value for both baseline and the specific post-baseline visit.|||millimeters squared||Standard Deviation|Mean
2588448|NCT02307682|Secondary|Average Change From Baseline in CSFTtot Over the Period Week 4 Through Week 48/96 - Study Eye|CSFTtot (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||micrometers||Standard Deviation|Mean
2588450|NCT02307682|Secondary|Average Change From Baseline in CSFTtot Over the Period Week 36 Through Week 48 - Study Eye|CSFTtot (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using SD-OCT, a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.|Baseline, Weeks 36, 40, 44, 48|FAS - LOCF|||micrometers||Standard Deviation|Mean
2588451|NCT02307682|Secondary|Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye|CSFTtot (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Spectral-Domain Optical Coherence Tomography (SD-OCT), a non-invasive measurement which produces cross-sectional and 3-dimensional images of the eye. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||micrometers||Standard Deviation|Mean
2588452|NCT02307682|Secondary|Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly (0-100 letters). A score of 65 to 70 letters represents a low to moderate visual acuity. Baseline was defined as the last measurement prior to first treatment. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS-LOCF|||percentage of subjects||95% Confidence Interval|Number
2588453|NCT02307682|Secondary|Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2588454|NCT02307682|Secondary|Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2588455|NCT02307682|Secondary|Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2588456|NCT02307682|Secondary|Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2588457|NCT02307682|Secondary|Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2588458|NCT02307682|Secondary|Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. 95% CI for binomial proportions was based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||percentage of subjects||95% Confidence Interval|Number
2588459|NCT02307682|Secondary|Average Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Weeks 84, 88, 92, 96|FAS - LOCF|||letters||Standard Deviation|Mean
2588460|NCT02307682|Secondary|Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||letters||Standard Deviation|Mean
2588461|NCT02307682|Secondary|Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||letters||Standard Deviation|Mean
2588462|NCT02307682|Secondary|Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96|FAS - LOCF|||letters||Standard Deviation|Mean
2588463|NCT02307682|Secondary|Proportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need During the Initial q12 Cycle (Week 16, Week 20)|"Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks q12w, after the initial three loading injections every 4 weeks q4w). A DAA was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% CIs were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for the brolucizumab 3 mg and 6 mg arms only."|Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96|FAS - efficacy/safety approach|||proportion of subjects||95% Confidence Interval|Number
2588464|NCT02307682|Secondary|Proportion of Subjects With Positive q12 Treatment Status up to Week 96|"Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks q12w, after the initial three loading injections every 4 weeks q4w). A DAA was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% CIs were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for the brolucizumab 3 mg and 6 mg arms only."|Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68, 76, 80, 88, 92, 96|FAS - efficacy/safety approach|||proportion of subjects||95% Confidence Interval|Number
2588465|NCT02307682|Secondary|Proportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Treatment Need During the First q12 Cycle (Week 16, Week 20)|"Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks q12w, after the initial three loading injections every 4 weeks q4w). A DAA was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% CIs were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for the brolucizumab 3 mg and 6 mg arms only."|Weeks 16, 20, 28, 32, 40, 44, 48|FAS - efficacy/safety approach|||proportion of subjects||95% Confidence Interval|Number
2588466|NCT02307682|Secondary|Proportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 48|"Positive q12 treatment status was defined as IVT injections per planned dosing regimen (one injection every 12 weeks q12w, after the initial three loading injections every 4 weeks q4w). A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w (one injection every 8 weeks) need. The estimate for the proportion of subjects with a positive q12w status at Week 48 were derived from Kaplan-Meier time to event analyses for the event of first q8w need, applying event allocations (in case of lack of efficacy and/or lack of safety=efficacy/safety approach) and censoring as described in the SAP. Censored subjects were considered to be not anymore under risk for a q8 need identification at later visits. Corresponding 95% Confidence Intervals (CIs) were derived from the LOGLOG transformation. No hypothesis testing was performed. This outcome measure was pre-specified for brolucizumab 3mg and 6 mg arms only."|Weeks 16, 20, 28, 32, 40, 44, 48|FAS - efficacy/safety approach|||proportion of subjects||95% Confidence Interval|Number
2588467|NCT02307682|Secondary|Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using ETDRS testing at 4 meters and reported in letters read correctly. For each subject, this endpoint was defined as the average of the changes from baseline to Weeks 36, 40, 44, and 48. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Weeks 36, 40, 44, 48|FAS - LOCF|||letters||Standard Deviation|Mean
2588468|NCT02307682|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye|BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Week 48|Full Analysis Set (FAS) - Last Observation Carried Forward (LOCF)|||letters||Standard Deviation|Mean
2588470|NCT02307526|Primary|Heart Rate||Average heart rate of 10 minutes supine rest before pyridostigmine and after 45 minutes at 45 degrees following pyridostigmine administration compared to 10 minutes supine rest before tilt and at 45 degrees during no-drug head-up tilt maneuver.||||bpm||Standard Deviation|Mean
2588471|NCT02307526|Primary|Diastolic Blood Pressure||Average diastolic blood pressure of 10 minutes supine rest before pyridostigmine and after 45 minutes at 45 degrees after pyridostigmine administration compared to 10 minutes supine rest before tilt and at 45 degrees during no-drug head-up tilt maneuver.||||mm Hg||Standard Deviation|Mean
2588472|NCT02307526|Primary|Systolic Blood Pressure||Average systolic blood pressure of 10 minutes supine rest before pyridostigmine and after 45 minutes at 45 degrees after pyridostigmine administration compared to 10 minutes supine rest before tilt and at 45 degrees during no-drug head-up tilt maneuver.||||mm Hg||Standard Deviation|Mean
2588473|NCT02307513|Secondary|Number of Participants With TEAEs During the Apremilast-Exposure Period|A TEAE is an adverse event (AE) with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. A serious AE is any AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. For both AEs and SAEs the investigator assessed the severity of the event according to the grading scale: Mild: asymptomatic or with mild symptoms, Moderate: symptoms causing moderate discomfort and local or noninvasive intervention is indicated or Severe: symptoms causing severe discomfort or pain, symptoms requiring medical/surgical intervention.|From lst dose of APR (for those randomized to APR at Week 0 or for those randomized to placebo and switched to APR at Week 12) after 28 days of last APR dose; median duration of APR treatment = 52 weeks (placebo/APR arm) and 63.86 weeks for APR/APR arm|AAT Population; Apremilast Participants as Treated (AAT) were those who received at least 1 dose of apremilast at any time during the study. Participants were included in the treatment group corresponding to the apremilast dosing regimen they actually received, irrespective of the treatment group to which they were randomized or re-randomized.|||Participants|||Count of Participants
2588474|NCT02307513|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo- Controlled Period|A TEAE is an adverse event (AE) with a start date on or after the date of the first dose of investigational product and no later than 28 days after the last dose of IP. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. A serious AE is any AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. For both AEs and SAEs the investigator assessed the severity of the event according to the grading scale: Mild: asymptomatic or with mild symptoms, Moderate: symptoms causing moderate discomfort and local or noninvasive intervention is indicated or Severe: symptoms causing severe discomfort or pain, symptoms requiring medical/surgical intervention.|From the date of the first dose of IP in the placebo-controlled phase to the date of the first dose of apremilast (APR) in the active treatment phase; median duration of treatment = 12 weeks|Safety population included all randomized participants who received at least 1 dose of study drug and were included in the treatment group for the treatment they actually received.|||Participants|||Count of Participants
2588475|NCT02307513|Secondary|Change From Baseline in Genital Ulcer Pain as Measured by VAS Score at Week 12|Pain of genital ulcers was measured using the visual analog scale. A 100-mm VAS pain scale for genital ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a validated, electronic hand-held device. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. A negative change from baseline indicates improvement.|Baseline to Week 12|The ITT population; participants who had genital ulcers at baseline. The last observation (baseline value if no post-baseline assessment) was carried forward for missing values at Week 12.|||Units on a Scale||Standard Error|Least Squares Mean
2588476|NCT02307513|Secondary|Change From Baseline in the Total Score of the Static Physician's Global Assessment (PGA) of Skin Lesions of BD at Week 12|"The scoring system for the Static Physician's Global Assessments was used as follows:~Score 0 = clear in severity and described as clear skin Score 1 = mild in severity and described as presence if 1 to 10 lesions (papules, pustules, cysts) at any anatomical site.~Score 2 = Moderate; presence of 11 to 20 lesions (papules, pustules, cysts) any anatomical site Score 3 = Severe; presence of >20 lesions (papules, pustules, cysts) any anatomical site"|Baseline to Week 12|The ITT population was defined as all randomized participants who received at least 1 dose of IP; Participants had BD skin lesions at baseline. LOCF imputation was used for missing values at Week 12.|||Units on a Scale||Standard Error|Least Squares Mean
2588477|NCT02307513|Secondary|Number of Oral Ulcers Following Loss of Complete Response Through Week 12|Number of oral ulcers following loss of complete response, ie, the first instance when a participant had a reappearance of oral ulcers following a complete response, during the Placebo-controlled Treatment Phase.|Baseline to Week 12|The intent to treat population was defined as all randomized participants who received at least 1 dose of investigational product. Participants who had a CR prior to Week 12.|||oral ulcers per participant||Standard Error|Least Squares Mean
2588478|NCT02307513|Secondary|Time to Recurrence of Oral Ulcers Following Loss of CR Who Had a CR Prior to Week 12|Time to recurrence of oral ulcer following the loss of CR was defined as the first instance when a participant had a reappearance of oral ulcers following a complete response, during the Placebo-controlled Treatment Phase. For participants who did not have oral ulcer recurrence or discontinued treatment before any oral ulcer recurrence during the Placebo-controlled Treatment Phase, time to event is censored at the last oral ulcer assessment during Placebo-controlled Treatment Phase; For participants without any oral ulcer assessment following the first complete response, time to event is censored to the first complete response date.|Baseline through Week 12|The ITT population was defined as all randomized participants who received at least 1 dose of IP. Participants who had a CR prior to week 12.|||Weeks||95% Confidence Interval|Median
2605733|NCT02107014|Primary|Change in MCP-1 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2588479|NCT02307513|Secondary|Percentage of Participants With no Oral Ulcers Following a Complete Response|The definition includes participants who remained oral ulcer free after achieving a complete response prior to Week 12.|Baseline to Week 12|The intent to treat population was defined as all randomized participants who received at least 1 dose of investigational product and had a complete response prior to Week 12.|||Percentage of Participants|||Number
2588480|NCT02307513|Secondary|Percentage of Participants Who Experienced a Complete Response For Genital Ulcers at Week 12|A complete response at Week 12 was defined as the participants who were genital ulcer free at week 12. Comparison of the percentage of participants who were genital ulcer-free (complete response: free from active genital ulcers) between the apremilast-treated and the placebo-treated groups at Week 12.|At Week 12|The ITT population with available data and was defined as all randomized participants who received at least 1 dose of IP. Participants with genital ulcers. Non-responder imputation (NRI) = participants with missing data at Week 12 were classified as non-responders.|||Percentage of Participants|||Number
2588481|NCT02307513|Secondary|Change From Baseline in Behçet's Disease Quality of Life (BD Qol) Scores at Week 12|The Behçet's Disease Quality of Life questionnaire was developed to measure the influence of BD on a particpant's life. It consists of 30 self-completed itemized questions that measure disease-related restrictions on the participant's activities and the participant's emotional response to these restrictions. The total score is the sum of all 30 items (each yes scores 1 and each no scores 0), with 0 representing no influence of Behçet's disease on a participant's quality of life and 30 representing the most severe influence. A negative change from baseline indicates improvement.|Baseline to Week 12|The ITT population was defined as all randomized participants who received at least 1 dose of IP. LOCF for a missing value at Week 12.|||Units on a Scale||Standard Error|Least Squares Mean
2588482|NCT02307513|Secondary|Percentage of Participants Who Experienced an Oral Ulcer Complete Response at Week 12|A complete response at Week 12 was defined as the participants who were oral ulcer free at week 12. Comparison of the percentage of participants who were oral ulcer-free between the apremilast-treated and the placebo-treated groups at Week 12.|At Week 12|The ITT population was defined as all randomized participants who received at least 1 dose of IP. Participants were included in the treatment group to which they were originally randomized. Non-responder imputation (NRI) = participants with missing data at Week 12 were classified as non-responders.|||Percentage of Participants|||Number
2588483|NCT02307513|Secondary|Time to Oral Ulcer Resolution (Complete Response)|Time to oral ulcer resolution was the time between the first dose date and the date when a complete response was achieved for the first time during the placebo-controlled treatment phase. For participants who did not achieve complete response or discontinued treatment before a complete response was achieved during the placebo-controlled treatment phase, time to event was censored at the last oral ulcer assessment date during the placebo-controlled treatment phase or the first dose date if no postbaseline ulcer assessment.|Baseline to Week 12|The intent to treat population was defined as all randomized participants who received at least 1 dose of IP. Participants were included in the treatment group to which they were originally randomized.|||Weeks||95% Confidence Interval|Median
2588484|NCT02307513|Secondary|Percentage of Participants Who Achieved an Oral Ulcer Complete Response (Oral Ulcer-Free) by Week 6 and Remained Oral Ulcer-Free for at Least 6 Additional Weeks|A complete response was defined as the participants who were oral ulcer-free. Comparison of the percentage of participants achieving an oral ulcer-free by Week 6, after start of dosing, and who remained oral ulcer free for at least 6 additional weeks during the 12-week Placebo-controlled Treatment Phase between the apremilast-treated and the placebo treated groups.|Baseline to Week 12|The ITT population was defined as all randomized participants who received at least 1 dose of IP. Participants were included in the treatment group to which they were originally randomized.|||Percentage of Participants|||Number
2588485|NCT02307513|Secondary|Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF): Clinician's Overall Perception of Disease Activity at Week 12|The Behçet's Disease Current Activity Form (BDCAF) consists of 3 component scores: the Behçet's disease Current Activity Index (BDCAI) score, the Patient's Perception of Disease Activity, and the Clinician's Overall Perception of Disease Activity. The Physician's Overall Perception of Disease Activity was assessed on a scale from 1 to 7, where a higher score indicates a higher level of disease activity and a negative change from baseline indicates improvement.|Baseline to Week 12|The intent to treat population with available data and was defined as all randomized participants who received at least 1 dose of IP. Participants were included in the treatment group to which they were originally randomized. LOCF imputation was used for missing values at week 12.|||Units on a Scale||Standard Error|Least Squares Mean
2588486|NCT02307513|Secondary|Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF): Patient's Perception of Disease Activity at Week 12|"The Behçet's Disease Current Activity Form (BDCAF) consists of 3 component scores: the Behçet's Disease Current Activity Index (BDCAI) score, the Patient's Perception of Disease Activity, and the Clinician's Overall Perception of Disease Activity.~The Patient's Perception of Disease Activity was assessed on a scale from 1 to 7, where a higher score indicates a higher level of disease activity and a negative change from baseline indicates improvement."|Baseline to Week 12|The intent to treat population with available data and was defined as all randomized participants who received at least 1 dose of IP. Participants were included in the treatment group to which they were originally randomized. LOCF imputation was used for missing values at week 12.|||Units on a Scale||Standard Error|Least Squares Mean
2588499|NCT02306928|Primary|50% fT>4xMIC: Free Piperacillin Concentration Maintained at a Level Fourfold the MIC for at Least 50% of the Dosing Interval.|The piperacillin plasma concentration-time profiles were best described by a two-compartment model. Each individual model predicted T>MIC was compared to clinical breakpoint MIC for P.aeruginosa (16 mg/L). The number of patients who achieved the pre-defined PK/PD target were reported.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.||||participants|||Number
2588500|NCT02306928|Secondary|Trough Piperacillin Plasma Concentration (Cmin)|Trough plasma concentration (Cmin) was predicted for each individual based on the final model fit.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.||||mg/L||Inter-Quartile Range|Median
2590389|NCT02284464|Secondary|Incidence of Diabetes Mellitus|Incidence of diabetes mellitus after kidney transplant in both groups at 1, 2, 3, 4, 6, 9, 12, 18 and 24 months|24 months||||Participants|||Count of Participants
2588487|NCT02307513|Secondary|Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF): Behçet's Disease Current Activity Index (BDCAI) at Week 12|The Behçet's Disease Current Activity Form (BDCAF) consists of 3 component scores: the Behçet's Disease Current Activity Index (BDCAI) score, the Patient's Perception of Disease Activity, and the Clinician's Overall Perception of Disease Activity. The BDCAI consists of 12 questions regarding disease manifestations over the previous 4 weeks, including oral and genital disease activity, as well as other manifestations of BD involving the skin, joints, GI tract, eyes, nervous system, and vascular system. The BDCAI score is the sum score of 12 items and ranges from 0 to 12. A higher score indicates higher level of disease activity (worsening), and a negative change from baseline indicates improvement.|Baseline to Week 12|The intent to treat population with available data and was defined as all randomized participants who received at least 1 dose of IP. Participants were included in the treatment group to which they were originally randomized. LOCF imputation was used for missing values at week 12.|||Units on a Scale||Standard Error|Least Squares Mean
2588488|NCT02307513|Secondary|Change From Baseline in Disease Activity as Measured by Behçet's Syndrome Activity Score (BSAS) at Week 12|The Behçet's Syndrome Activity Score (BSAS) contains 10 questions, including ones that assess the number of new oral and genital ulcers and skin lesions; assess gastrointestinal (GI), CNS, vascular, and ocular involvement; and evaluates the subject's current level of discomfort. The Behçet's Syndrome Activity Score ranges from 0 to 100, with a higher score indicating a higher level of activity. A negative change from baseline indicates improvement.|Baseline to Week 12|The intent to treat population with available data and was defined as all randomized participants who received at least 1 dose of IP. Participants were included in the treatment group to which they were originally randomized. LOCF imputation was used for missing values at week 12.|||Units on a Scale||Standard Error|Least Squares Mean
2588489|NCT02307513|Secondary|Change From Baseline in Oral Ulcer Pain as Measured by Visual Analogue Scale (VAS) Score at Week 12|Pain of oral ulcers was measured using the visual analog scale (VAS). A 100-mm VAS pain scale for oral ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a validated electronic, hand-held device. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was recorded. A negative change from baseline indicates improvement.|Baseline to Week 12|The ITT population with available data and was defined as all randomized participants who received at least 1 dose of IP. Last observation carried forward (LOCF) imputation was used. LOCF is the last observation (baseline value if no post-baseline assessment) is carried forward for missing values at Week 12.|||Units on a Scale||Standard Error|Least Squares Mean
2588490|NCT02307513|Primary|Area Under the Curve (AUC) for the Number of Oral Ulcers (Counts) From Baseline Through Week 12 (AUC Week 0-12)|The area under curve (AUC^85) compared the placebo group and the apremilast 30 mg PO BID group using a two-tailed parametric ANCOVA test at the 0.05 level. The ANCOVA included AUC^85 as the response variable; treatment, sex and region as factors and the number of oral ulcers at baseline as a covariate. The multiple imputation (MI) method was used to impute the missing oral ulcer counts on study visits from Day 1 through Week 12.|Baseline to Week 12|The intent to treat (ITT) population was defined as all randomized participants who received at least 1 dose of IP. Participants were included in the treatment group to which they were originally randomized. Multiple Imputation (MI)- used to impute missing oral ulcer counts.|||Ulcers*days||Standard Error|Least Squares Mean
2588491|NCT02307318|Secondary|Incidence of Hematoma and/or Ecchymosis|Number of patients who experience hematoma (bruising) and/or ecchymosis (discoloration of the skin caused by bleeding underneath) at the access site as measured by observation just prior to discharge.|Day1||||Participants|||Count of Participants
2588492|NCT02307318|Secondary|Changes in Circulation, Movement and Sensation|Number of patients who experience changes in circulation, movement and sensation in the hand and wrist of the access site as measured by standard of care nursing assessments.|Day1||||Participants|||Count of Participants
2588493|NCT02307318|Primary|Incidence of Thrombosis|Number of patients who experience thrombosis (blood clot) at the access site as measured by ultrasound between 4 hours and 24 hours post-procedure.|4 hours post-surgery||||Participants|||Count of Participants
2588494|NCT02307318|Primary|Incidence of Arterial Bleeding|Number of patients who experience arterial bleeding after use of the Softseal hemostatic device and manual compression at the transradial access site as measured by observation.|Day1||||Participants|||Count of Participants
2588495|NCT02307266|Primary|Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS)|"To prevent bias, treatment adherence was assessed without subject's knowledge using a Medication Event Monitoring System (MEMS). The treatment was placed in a container fitted with a MEMS cap which recorded the time/date every time it was opened and/or closed. A day with at least one opening was considered a day the subject was adherent. Mean rate of adherence in % corresponds to the number of days the subject was adherent dividided by the total number of days of the study (84 days) times 100.~Analysis was performed on the worst-case population: Missing data were considered as non-adherence."|week 12|Only subjects with usable MEMS data were analyzed, therefore the number of subjects in the analysis population is not the full population.|||percentage of adherence||Standard Deviation|Mean
2588496|NCT02307188|Primary|Atrial Fibrillation Dominant Frequency|Electrogram signal analysis will be performed to assess the dominant frequency of the atrial fibrillation electrograms collected by this catheter. These values will be correlated to patient outcomes.|1 year|Because the quality of intracardiac electrogram data for the one patient to complete the study was not sufficient for analysis, this outcome measure was not analyzed.||||||
2588497|NCT02307123|Secondary|Glasgow Outcome Score (GOS)|GOS 1 = Death GOS 2 = Poor neurological outcome GOS 3 = Good neurological outcome Modified from the original 5 - step classification.|1 year||||percentage of good neurological outcome|||Number
2588498|NCT02307123|Primary|Mortality||1 year||||percentage of one year mortality|||Number
2588579|NCT02304926|Primary|High-density Lipoprotein Cholesterol (HDLc) Before and After Simvastatin/Ezetimibe Administration|High-density lipoprotein cholesterol (HDLc) concentration was measured using a direct method|Baseline, 4 weeks and 8 weeks||||mg/dl||Standard Deviation|Mean
2588501|NCT02306928|Secondary|The Area Under the Plasma-concentration Time Curve Concentration-time Curve From 0-8 Hours After the Studied Dose (AUC 0-8)|Area under the free plasma concentration-time curve (fAUC0-8) was predicted for each individual based on the final model fit.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.||||mg.hr/L||Inter-Quartile Range|Median
2588502|NCT02306928|Secondary|The Maximum Concentration of Piperacillin (Cmax)|Maximum plasma concentration was predicted for each individual based on the final model fit.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.||||mg/L||Inter-Quartile Range|Median
2588503|NCT02306928|Primary|100% f T>MIC: Free Piperacillin Concentration Maintained Above the MIC Throughout the Dosing Interval.|The piperacillin plasma concentration-time profiles were best described by a two-compartment model. Each individual model predicted T>MIC was compared to clinical breakpoint MIC for P.aeruginosa (16 mg/L). The number of patients who achieved the pre-defined PK/PD target were reported.|Participants were followed up to the third dosing interval after initiation of piperacillin/tazobactam. An average of 24 hours.||||participants|||Number
2588504|NCT02306850|Secondary|Response|Response to treatment|24 weeks||||Participants|||Count of Participants
2588505|NCT02306850|Primary|Resectability Rate|"'Resectability rate' is defined as the proportion of subjects in the trial that were unresectable at baseline who after treatment with pembrolizumab are now eligible for curative resection with complete metastectomy. The primary endpoint resectability rate is merely a novel statistical approach; it has no bearing on the duration of treatment that an individual patient may receive during the trial."|24 weeks||||Participants|||Count of Participants
2588506|NCT02306759|Secondary|ED Length of Stay (Minutes)|ED Length of stay (minutes) throughout study period|throughout study completion||||minutes||Standard Deviation|Mean
2588507|NCT02306759|Secondary|Mean Consumption of Rescue Analgesia||at designated intervals during study period (0, 15, 30, 45, 60, 75, 90, 105, 120 minutes)||||milligrams||Standard Deviation|Mean
2588508|NCT02306759|Secondary|Patient Satisfaction of Pain Control Based on a Likert Scale|Patient satisfaction of pain control based on a Likert Scale at the end of study completion, an average of 90 minutes. Scores reported out of scale of 10, 10 being most satisfied and 1 being least satisfied.|At the end of study period||||units on a scale||Standard Deviation|Mean
2588509|NCT02306759|Secondary|Number of Participants With Adverse Events|Incidence or number of participants with adverse events.|during the study period|Nausea was reported in three patients who received placebo and one patient who received ketamine. Dreams was reported in 1 patient who received placebo and one patient who received ketamine.|||participants|||Number
2588510|NCT02306759|Primary|Change From Baseline of Pain as Described by Numeric Rating Scale (NRS) [Minimum:0, Maximum 10] at 15 Minutes|Change from Baseline of Pain as described by Numeric Rating Scale (NRS) [minimum:0, maximum 10] at 15 minutes. Lower values indicate worst outcomes while higher values indicate better outcomes.|15 minutes after administration of study intervention||||units on a scale||Inter-Quartile Range|Median
2588511|NCT02306694|Other Pre-specified|Participant Quality of Life|Haem-A-QoL was used to assess various components indicating participants quality of life. Haem-A-QoL is composed of 10 subsections with 3-8 questions in each. Questions are rated from 1 to 5, with 5 being the most negative influence on quality of life. Some questions are worded in the inverse, such that the 1 corresponds to the greatest negative impact on quality of life. In this case, the score is inverted to match the remainder of questions for statistical analysis. A Transformed scores is calculated for each subsection and for the total of all the subjections. The scores range from 0 (best quality of life) to 225 (worst quality of life).|5 days||||score on a scale||Standard Deviation|Mean
2588512|NCT02306694|Other Pre-specified|Hemophilia Activities List (HAL) and the International Society of Thrombosis and Hemostasis- Bleeding Assessment Tool (ISTH-BAT)|The HAL is used to assess physical activity; scores range from 42 (severe problems) to 252 (no problems). The ISTH-BAT was used to evaluate bleeding phenotype. Each section was scored using a 0 to 4 scale for each of the 12 subsections. A total score was calculated by taking the sum of each section, resulting in a range of scores from 0 (no bleeding history) to 48 (most extensive clinical intervention for bleeding)|5 days||||score on a scale||Standard Deviation|Mean
2588513|NCT02306694|Other Pre-specified|Medication Adherence|VERITAS instrument self-reported compliance with factor replacement regimen. The VERITAS is composed of 6 subsections, where scores range from 1 (best adherence) to 5 (worst adherence). A total score was calculated with the minimum score of 24 (most adherent) and a maximum score of 120 (least adherent)|5 days||||score on a scale||Standard Deviation|Mean
2588514|NCT02306694|Primary|Plasma Cytokine Concentration Differences From 0-hour to 24-hour|cytokines were measured using ELISA/magnetic bead multiplex kits. We calculated concentration change from hour 0 to hour 24. Cytokines: FGF, C-Terminal telopeptide (CTX-1), Dickkopf WNT signaling pathway inhibitor 1(DKK1), Eotaxin, fibroblast growth factor 23(FGF23), interferon gamma, interleukin 13, interleukin 1 beta, interleukin receptor 1 antagonist, interleukin 2, interleukin 4, interleukin 6, interleukin 17, interleukin 8, interleukin 9 Insulin, interferon gamma induced protein 10 (IP10), Leptin, monocyte chemoattractant protein1, monocyte chemoattractant protein1, macrophage inflammatory protein 1a (MIP1a), osteoclasts, Osteoprotegerin, osteopontin, platelet derived growth factors, parathyroid horomone, Recepter activator of nuclear factor kappa-B ligand (RANKL), chemokine ligand 5, sclerostin, transforming growth factor-beta 1, transforming growth factor beta 2, transforming growth factor beta 3, tumor necrosis factor alpha, vascular endothelial growth factor, MIP1b.|24 hours|Some participant samples were unable to be analyzed at all time points due to poor sample quality or other factors.|||pg/mL||Standard Deviation|Mean
2588515|NCT02306694|Primary|Quality of Life Using the VAS and EQ-5D-3L|Visual Analog Scale (VAS) via the EQ-5D-3L was used to report participants self-rated health. EQ-5D-3L total score ranges from 5 (no problems) to 15 (significant problems). VAS scores could range from 0 (worst health ever) to 100 (best health ever).|5 days||||score on a scale||Standard Deviation|Mean
2588516|NCT02306694|Primary|Joint Health|Hemophilia Joint Health Score (HJHS); with a higher score representing worst outcomes, scores could range from 0 (no problems) to a max score of 120 (severe problems).|5 days||||score on a scale||Standard Deviation|Mean
2588624|NCT02304159|Primary|Number of Participants With Adverse Events|This field states the number of participants who had an adverse event|From baseline (start of study drugs) to last day of taking study drugs; an average of 20 weeks.||||Participants|||Count of Participants
2588517|NCT02306694|Primary|Bone Biomarker Density (BMD)|BMD was measured as Z-scores/T-scores using Dual-Energy X-ray Absorptiometry (DEXA) scanning; specifically looking at Spine, Hip/Neck, and Hip total scores. BMD Z-scores compare what would be expected in someone your age and body size. A Z-score, is a unit of standard deviation, where above 0 would indicate the bones are more dense than expected, while a Z-score below 0 would indicate the bones were less dense.|5 days||||Z-Score||Standard Deviation|Mean
2588518|NCT02306265|Other Pre-specified|Cancer-positive Participants|Participants confirmed to be positive for cancer on histology review.|Duration of study - approximately 26 months|Participants who completed the study, including conclusive histology review, and cancer status was positive.|||Participants|||Count of Participants
2588519|NCT02306265|Other Pre-specified|Device Malfunctions by Modality (DBT or FFDM).|Number of device malfunctions by modality (DBT or FFDM)|Duration of study -approximately 26 months|One device malfunction reported for FFDM; Zero device malfunctions reported for DBT.|||Malfunctions|||Number
2588520|NCT02306265|Primary|Number of Participants With Imaging Data Collected|Collect breast image data using two (2) methods: Digital Breast Tomosynthesis (DBT) and Full Field Digital Mammography (FFDM) from asymptomatic women undergoing screening mammography.|within 30 days of enrollment|The efficacy population for primary outcome were subjects meeting study inclusion/exclusion criteria with no protocol violations judged to affect the ability to evaluate the subject, whose DBT/FFDM images were diagnostically evaluable and whose mammography images were available for independent blinded evaluation, regardless of image quality.|||Participants|||Count of Participants
2588521|NCT02305888|Secondary|Percentage of Participants With Complete Clearance of AKs|Complete clearance was defined as no clinically visible AKs. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic.|8 weeks||||percentage of participants||95% Confidence Interval|Number
2588522|NCT02305888|Secondary|Percent Reduction in AK Count of Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic|Hypertrophic/Hyperkeratotic lesions were identified at baseline (Day 1), Week 4 and Week 8.|4 weeks and 8 weeks / From baseline to Week 4, and Week 8|For this efficacy analysis only participants with lesions identified as hypertrophic/hyperkeratotic at baseline were included in the analysis.|||percentage of reduction||95% Confidence Interval|Mean
2588523|NCT02305888|Secondary|Percent Reduction in AK Count Excluding Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic|The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at baseline (Day 1), Week 4, and Week 8. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic.|4 weeks and 8 weeks / From baseline to Week 4, and Week 8||||percentage of reduction||95% Confidence Interval|Mean
2588524|NCT02305888|Primary|Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions)|"For face/chest, a DLT was defined as one or more of the following three LSRs:~Crusting Grade 4~Erosion/Ulceration Grade 4~Vesiculation/Pustulation Grade 4~Or two or more of the following five LSRs:~Erythema Grade 4~Crusting Grade 3~Swelling Grade 4~Erosion/Ulceration Grade 3~Vesiculation/Pustulation Grade 3~For scalp a DLT was defined as erosion/ulceration Grade 4~For trunk/extremities a DLT was defined as one or more of the following three LSRs:~Crusting Grade 4~Erosion/Ulceration Grade 4~Vesiculation/Pustulation Grade 4~Or two or more of the following four LSRs:~Crusting Grade 3~Swelling Grade 4~Erosion/Ulceration Grade 3~Vesiculation/Pustulation Grade 3"|8 days / From baseline (Day 1) to Day 8||||Participants|||Count of Participants
2588525|NCT02305797|Secondary|Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Visit 7 (Day 42)|Measured on a 7-point scale 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill. Baseline was defined as the last non-missing value prior to receiving double-blind study drug.|Day 42 (Visit 7)|The modified Intent-to-treat (mITT) population was used for all analyses.|||CGI-S score||Standard Error|Least Squares Mean
2588526|NCT02305797|Primary|Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42)|HAM-A Total Score was rated by the clinician. Scores range from 0 to 56. A lower score is favorable. Baseline was defined as the last non-missing value prior to receiving double-blind study drug.|Day 42 (Visit 7)|A total of 495 patients were randomly assigned to a treatment group and received at least one dose of study treatment. The mITT Set included 239 patients randomly assigned to EDG004 and 240 patients randomly assigned to placebo.|||Score on scale||Standard Error|Least Squares Mean
2588527|NCT02305758|Secondary|Objective Response Rate (ORR)|ORR was defined as the proportion of participants with a complete (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) for target lesions, assessed by computed tomography (CT). Complete response (CR) was defined as disappearance of all target lesions; partial response (PR) ≥30% decrease in the the sum of diameters of target lesions, taking as reference the baseline sum diameters. For participants who underwent surgery, ORR was not evaluated after surgery.|Per protocol, post-baseline tumor assessment was conducted every 8 weeks from Cycle 1 Day 1 until radiographic progression. The maximum observed follow up duration at the progression-free survival analysis time was 579 days.|All randomized participants|||Participants|||Count of Participants
2588528|NCT02305758|Secondary|Overall Survival (OS): Time to Event|Overall survival was defined as the number of days from the date that the participant was randomized to the date of the participant's death. All events of death were included, regardless of whether the event occurred while the participant was still taking or had discontinued study drug. If a participant had not died, the data were censored at the date last known to be alive. The OS distribution was estimated using Kaplan-Meier methodology. Point estimates and 95% confidence intervals (95% CIs) for the OS distribution quartiles are provided.|Survival information was to be collected 4 wks after the last study visit, continuing every 4 wks for 1 yr, then every 8 wks for up to 2 more yrs or until death. The maximum observed follow up duration at the overall survival analysis time was 914 days.|All randomized participants|||days||95% Confidence Interval|Number
2588558|NCT02305238|Secondary|Percentage of Participants Who Gained at Least 15 Letters of Vision Compared to Baseline at Week 52||Baseline and Week 52|The outcome measure is analyzed based on full analysis set (FAS) including all randomized participants who received any study drug after randomization and had a baseline and at least one BCVA assessment after Week 16 (i.e. post randomization). The FAS was analyzed as randomized.|||percentage of participants||95% Confidence Interval|Number
2605734|NCT02107014|Primary|Change in MIP-1β From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2588529|NCT02305758|Primary|Progression-Free Survival (PFS): Time to Event|PFS was defined as the number of days from the date the participant was randomized to the date the participant experienced an event of disease progression or death, whichever occurred first. All events of disease progression were included, whether the participant was still taking or had discontinued study drug. Events of death were included for participants who had not experienced an event of disease progression, if the death occurred within 8 weeks of the last evaluable disease progression assessment. If the participant did not have an event of disease progression and the participant had not died as defined above, data were censored at the date of the participant's last evaluable disease progression assessment. The PFS distribution was estimated using Kaplan-Meier methodology. Point estimates and 95% confidence intervals (95% CIs) for the PFS distribution quartiles are provided.|Every 8 weeks from Cycle 1, Day 1 until radiographic progression was observed. The maximum observed follow up duration at the progression-free survival analysis time was 579 days.|All randomized participants|||days||95% Confidence Interval|Number
2588530|NCT02305732|Primary|The Proportion of Transfused INTERCEPT Platelet Components Associated With Any Transfusion Reactions and/or Unrelated Adverse Event|"Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused.~Unrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused.~1 Transfusion = 1 Intercept Platelet Component."|1 year|This outcome summarizes the 256 INTERCEPT platelet components transfused during the INTERCEPT-Treatment-Use phase of the study. A total of 90 patients received at least one INTERCEPT platelet component.|||Platelet Components|Platelet Components||Count of Units
2588531|NCT02305732|Primary|The Proportion of Patients With Any Unrelated Adverse Event|Unrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused.|1 year||||Participants|||Count of Participants
2588532|NCT02305732|Primary|The Proportion of Patients With Any Transfusion Reactions|Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused.|1 year||||Participants|||Count of Participants
2588533|NCT02305732|Primary|The Proportion of Patients With a Confirmed Case of Transfusion-transmitted Chikungunya Virus or Dengue Infection||1 year||||Participants|||Count of Participants
2588534|NCT02305732|Primary|The Proportion of Transfused INTERCEPT Platelet Components With a Post-treatment Platelet Dose ≥ 3.0×10^11 Platelets.|"INTERCEPT platelet components (PCs) manufactured for this study are leukocyte reduced apheresis PCs processed using the INTERCEPT Blood System (IBS) for platelets. The IBS for platelets is a Class III medical device approved by the FDA for the ex-vivo preparation and storage of pathogen reduced apheresis PCs. The system is used to inactivate a broad range of pathogens, including viruses, bacteria, and protozoan parasites as well as contaminating donor leukocytes. Post-manufacturing, INTERCEPT PCs are either transfused or stored according to blood center standard operating procedures, US FDA, and AABB Guidelines.~Subjects enrolled in this study are transfused with INTERCEPT PCs as dictated by the treating physician. One platelet component was treated as one platelet transfusion for the purpose of data analysis in this study."|1 year|"This outcome summarizes the 256 INTERCEPT platelet components transfused during the INTERCEPT-Treatment-Use phase of the study. A total of 90 patients received at least one INTERCEPT platelet component. 1 Transfusion = 1 Intercept Platelet Component."|||Platelet Components|Platelet Components||Count of Units
2588535|NCT02305446|Other Pre-specified|Number of Adult Volunteers Whose Blood Can be Used as a Reference in Serum Bactericidal Activity (SBA) Test.|The number of identified healthy adult volunteers with pre and postvaccination blood donations were summarized to establish a control sera panel to be used as a reference in SBA test.|Study day 1 blood sample was drawn between day -5 and day 1. Postvaccination 2 blood sample was drawn between day 23 and day 37 postvaccination 2.|The analysis was performed on the all enrolled dataset.|||Participants|||Number
2588536|NCT02305446|Primary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination.|From day 1 to day 7 after each vaccination (Vaccination 1: Day 1 to Day 7; Vaccination 2: Day 61 to Day 67)|Analysis were evaluated on the Unsolicited Safety Set|||Subjects|||Number
2588537|NCT02305381|Secondary|HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target|Percentage of participants with HbA1c below or equal to 6.5% after 30 weeks treatment. Missing data imputed from a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit.|After 30 weeks treatment|Full analysis set.|||percentage of subjects|||Number
2588538|NCT02305381|Secondary|HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target|Percentage of subjects with HbA1C below 7.0% after 30 weeks treatment. Missing data imputed from a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit.|After 30 weeks treatment|Full analysis set|||percentage of subjects|||Number
2588539|NCT02305381|Secondary|Patient Reported Outcomes, Diabetes Treatment Satisfaction Questionnaire (DTSQ)|The DTSQs questionnaire was used to assess subjects' treatment satisfaction and contained 8 components and evaluates the diabetes treatment (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings towards the treatment. The result presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. The post-baseline responses are analysed using an ANCOVA model with treatment, country and stratification variables (HbA1c level at screening [<= 8.0% or > 8.0%] and use of metformin [yes or no]) as fixed factors and baseline value as covariate. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using last observation carried forward.|week 0, week 30|Full analysis set|||scores on a scale||Standard Error|Least Squares Mean
2588578|NCT02304926|Primary|Triglycerides Before and After Simvastatin/Ezetimibe Administration|Triglyceride concentration were measured by enzymatic assay|Baseline, 4 weeks and 8 weeks||||mg/dl||Inter-Quartile Range|Median
2605735|NCT02107014|Primary|Change in RANTES From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2588540|NCT02305381|Secondary|Change in Systolic and Diastolic Blood Pressure|Estimated mean change from baseline in systolic and diastolic blood pressure at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.|week 0, week 30|Full analysis set|||mm Hg||Standard Error|Least Squares Mean
2588541|NCT02305381|Secondary|Change in Insulin Dose|Estimated mean change from baseline in insulin dose at week 30 was measured in terms of ratio to baseline. Responses at week 30 are analysed using an Analysis of covariance model with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using last observation carried forward.|week 0, week 30|Full analysis set|||ratio||Standard Error|Least Squares Mean
2588542|NCT02305381|Secondary|Change in Fasting Plasma Glucose (FPG)|Estimated mean change from baseline in FPG at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.|week 0, week 30|Full analysis set.|||mg/dL||Standard Error|Least Squares Mean
2588543|NCT02305381|Secondary|Change in Body Weight|Estimated mean change from baseline in body weight at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.|Week 0, week 30|Full analysis set.|||kg||Standard Error|Least Squares Mean
2588544|NCT02305381|Primary|Change in HbA1c (Glycosylated Haemoglobin)|Estimated mean change from baseline in HbA1c at week 30. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. Mean estimates are adjusted according to observed baseline distribution. Missing data was imputed using mixed model for repeated measurements.|Week 0, week 30|Full analysis set included all randomised subjects who had received at least 1 dose of randomised semaglutide or placebo.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2588545|NCT02305329|Secondary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity|AUC0-∞ - Area under the plasma concentration-time curve extrapolated to infinity.|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose||||h.ng/mL||Standard Deviation|Mean
2588546|NCT02305329|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve Calculated Between Time of Administration and Time t||before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose||||h.ng/mL||Standard Deviation|Mean
2588547|NCT02305329|Secondary|Tmax - Time of Occurrence of Cmax of 9-1067|tmax - time of occurrence of Maximum Observed Plasma Concentration of 9-1067|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose||||hours||Full Range|Median
2588548|NCT02305329|Primary|Cmax - Maximum Observed Plasma Concentration of 9-1067|Cmax - maximum observed plasma concentration of 9-1067.|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose||||ng/mL||Standard Deviation|Mean
2588549|NCT02305316|Secondary|AUC0-inf - Area Under the Plasma Concentration-time Curve From Time 0 to the Infinity|AUC0-inf - Area under the plasma concentration-time curve from time 0 to the infinity.|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.||||ng.h/mL||Standard Deviation|Mean
2588550|NCT02305316|Secondary|Tmax - Time of Occurrence of Cmax of BIA 9-1067|tmax - time of occurrence of maximum observed plasma concentration of BIA 9-1067|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.||||hours||Full Range|Mean
2588551|NCT02305316|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration|AUC0-t - Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration of BIA 9-1067|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.||||ng.h/mL||Standard Deviation|Mean
2588552|NCT02305316|Primary|Cmax - Maximum Observed Plasma Concentration|Maximum observed plasma concentration of BIA 9-1067|before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose.||||ng/mL||Standard Deviation|Mean
2588553|NCT02305277|Secondary|Tmax - Time of Occurrence of Cmax||before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose||||hours||Full Range|Median
2588554|NCT02305277|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve for BIA 9-1067|Area Under the plasma concentration-time Curve from time 0 to the time of last quantifiable concentration|before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose||||ng.h/mL||Standard Deviation|Mean
2588555|NCT02305277|Primary|Cmax - Maximum Observed Plasma Concentration||before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose||||ng/mL||Standard Deviation|Mean
2588556|NCT02305238|Secondary|Percentage of Participants Without Fluid on Optical Coherence Tomography (OCT) at Week 52|"A participant was classified as without fluid if Evidence of new or persistent fluid on OCT was No."|Week 52|The outcome measure is analyzed based on full analysis set (FAS) including all randomized participants who received any study drug after randomization and had a baseline and at least one BCVA assessment after Week 16 (i.e. post randomization). The FAS was analyzed as randomized.|||Percentage of participants||95% Confidence Interval|Number
2588557|NCT02305238|Secondary|Mean Change in Central Retinal Thickness (CRT) From Baseline at Week 52||Baseline and week 52|The outcome measure is analyzed based on full analysis set (FAS) with number of subjects evaluable for this specific end point.|||μm||95% Confidence Interval|Mean
2588559|NCT02305238|Secondary|Percentage of Participants Who Maintained Vision at Week 52|A participant was classified as maintaining vision if the participant had lost fewer than 15 letters in the ETDRS letter score compared to baseline.|Week 52|The outcome measure is analyzed based on full analysis set (FAS) including all randomized participants who received any study drug after randomization and had a baseline and at least one BCVA assessment after Week 16 (i.e. post randomization). The FAS was analyzed as randomized.|||percentage of participants||95% Confidence Interval|Number
2588560|NCT02305238|Primary|Mean Change From Baseline in BCVA at Week 52|Visual functions of the study eye (at every visit) and the fellow eye were assessed, according to the ETDRS protocol as described in detail in the operation manual. A higher score represents better functioning.|Baseline and Week 52|The outcome measure is analyzed based on full analysis set (FAS) including all randomized participants who received any study drug after randomization and had a baseline and at least one BCVA assessment after Week 16 (i.e. post randomization). The FAS was analyzed as randomized.|||letters||Standard Deviation|Mean
2588561|NCT02305017|Secondary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity.|AUC0-∞ - AUC from time 0 to infinity following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration.|before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose||||ng.h/mL||Standard Deviation|Mean
2588562|NCT02305017|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification|AUC0-t - area under the plasma concentration-time curve (AUC) from time zero to the last sampling time following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration|before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose||||ng.h/mL||Standard Deviation|Mean
2588563|NCT02305017|Secondary|Tmax - Time of Occurrence of Cmax|Tmax - time of occurrence of Cmax following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration.|before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose||||hours||Full Range|Mean
2588564|NCT02305017|Primary|Cmax - Maximum Plasma Concentration|Cmax - Maximum plasma concentration of opicapone on Day 12 following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration|before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose||||ng/mL||Standard Deviation|Mean
2588565|NCT02304926|Secondary|Levels of E-selectin Before and After Simvastatin/Ezetimibe Administration|E-selectin was evaluated in serum by Luminex® 200™ system|Baseline, 4 weeks and 8 weeks||||ng/ml||Standard Deviation|Mean
2588566|NCT02304926|Secondary|Levels of Intercellular Adhesion Molecule 1 (ICAM-1) Before and After Simvastatin/Ezetimibe Administration|The intercellular adhesion molecule 1 (ICAM-1) was evaluated in serum by Luminex® 200™ system|Baseline, 4 weeks and 8 weeks||||ng/ml||Standard Deviation|Mean
2588567|NCT02304926|Secondary|Levels of Vascular Cell Adhesion Molecule 1 (VCAM-1) Before and After Simvastatin/Ezetimibe Administration|The vascular cell adhesion molecule 1 (VCAM-1) was evaluated in serum by Luminex® 200™ system|Baseline, 4 weeks and 8 weeks||||ng/ml||Standard Deviation|Mean
2588568|NCT02304926|Primary|Apolipoprotein B Before and After Simvastatin/Ezetimibe Administration|Levels of apolipoprotein B were determined by inmunonephelometry|Baseline, 4 weeks and 8 weeks||||mg/dl||Standard Deviation|Mean
2588569|NCT02304926|Secondary|Leukocyte Rolling Velocity Before and After Simvastatin/Ezetimibe Administration|Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy.The rolling velocity in the field of focus was determined by measuring the time required by 20 consecutive leukocytes to cover a distance of 100 μm.|Baseline, 4 weeks and 8 weeks||||micrometer/second||Standard Deviation|Mean
2588570|NCT02304926|Secondary|Leukocyte Adhesion Before and After Simvastatin/Ezetimibe Administration|Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy. Adhesion was evaluated by counting the number of polymorphonuclear cells that maintained stable contact with human umbilical vein endothelial cells (HUVEC) for 30 seconds.|Baseline, 4 weeks and 8 weeks||||polymorphonuclear cells/mm2||Standard Deviation|Mean
2588571|NCT02304926|Primary|Low Density Lipoprotein Size Before and After Simvastatin/Ezetimibe Administration|LDL subfractions were separated by high-resolution polyacrylamide gel tubes using the Lipoprint® system. The LDL electrophoretic profile allows 2 patterns to be defined: pattern A or large and buoyant LDL, and pattern non-A or small and dense LDL.|Baseline, 4 weeks and 8 weeks||||Angström||Standard Deviation|Mean
2588572|NCT02304926|Primary|Non-HDL Cholesterol Before and After Simvastatin/Ezetimibe Administration|Non-HDLc concentration was obtained by calculating the difference between total cholesterol and HDLc|Baseline, 4 weeks and 8 weeks||||mg/dl||Standard Deviation|Mean
2588573|NCT02304926|Secondary|Leukocyte Rolling Flux Before and After Simvastatin/Ezetimibe Administration|Interactions between leukocytes and human umbilical vein endothelial cells were evaluated by flow chamber microscopy. Leukocyte rolling was estimated as the number of leukocytes rolling over 100 μm2 of the endothelial monolayer during a 1-min period.|Baseline, 4 weeks and 8 weeks||||polymorphonuclear cells/min||Standard Deviation|Mean
2588574|NCT02304926|Secondary|Levels of Glutathione (GSH) Before and After Simvastatin/Ezetimibe Administration|Oxidative stress markers (levels of glutathione (GSH)) was measured at baseline and after treatment by fluorometric techniques|Baseline, 4 weeks and 8 weeks||||Fluorescence Units||Standard Deviation|Mean
2588575|NCT02304926|Secondary|Membrane Potential Before and After Simvastatin/Ezetimibe Administration|Oxidative stress markers (membrane potential) was measured at baseline and after treatment by fluorometric techniques|Baseline, 4 weeks and 8 weeks||||Fluorescence Units||Standard Deviation|Mean
2588576|NCT02304926|Secondary|Reactive Oxygen Species (ROS) Production Before and After Simvastatin/Ezetimibe Administration|Oxidative stress markers (Reactive oxygen species (ROS) production) was measured at baseline and after treatment by fluorometric techniques|Baseline, 4 weeks and 8 weeks||||Fluorescence Units||Standard Deviation|Mean
2588577|NCT02304926|Secondary|Mitochondrial Oxygen (O2) Consumption Before and After Simvastatin/Ezetimibe Administration|Oxidative stress markers (mitochondrial oxygen (O2) consumption) was measured at baseline and after treatment by Clark electrode|Baseline, 4 weeks and 8 weeks||||Nmol O2/min/million cells||Standard Deviation|Mean
2605736|NCT02107014|Primary|Change in Eotaxin From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2588580|NCT02304926|Secondary|Levels of Tumor Necrosis Factor α (TNF-α) Before and After Simvastatin/Ezetimibe Administration|Levels of proinflammatory cytokines (tumor necrosis factor α (TNF-α)) were analysed with a Luminex® 200™ system|Baseline, 4 weeks and 8 weeks||||pg/ml||Standard Deviation|Mean
2588581|NCT02304926|Secondary|Levels of Interleukin-6 (IL-6) Before and After Simvastatin/Ezetimibe Administration|Levels of proinflammatory cytokines (interleukin-6 (IL-6)) were analysed with a Luminex® 200™ system|Baseline, 4 weeks and 8 weeks||||pg/ml||Standard Deviation|Mean
2588582|NCT02304926|Secondary|Levels of High-sensitive C-reactive Protein (hsCRP) Before and After Simvastatin/Ezetimibe Administration|Levels of high-sensitive C-reactive protein (hsCRP) were analysed by a latex-enhanced inmunonephelometric assay|Baseline, 4 weeks and 8 weeks||||mg/l||Standard Deviation|Mean
2588583|NCT02304926|Primary|Low-density Lipoprotein Cholesterol (LDLc) Before and After Simvastatin/Ezetimibe Administration|Low-density lipoprotein cholesterol (LDLc) concentration was calculated using the method of Friedewald.|Baseline, 4 weeks and 8 weeks||||mg/dl||Standard Deviation|Mean
2588584|NCT02304926|Primary|Total Cholesterol Before and After Simvastatin/Ezetimibe Administration|Total cholesterol concentration was measured by enzymatic assay|Baseline, 4 weeks and 8 weeks||||mg/dl||Standard Deviation|Mean
2588585|NCT02304705|Other Pre-specified|Change in Blood Pressure|through standard cuff method, participants will have blood pressure measured to determine systolic and diastolic blood pressure as well as mean arterial pressure. data will be collected at baseline and 90 days.|Baseline and 90 days|||||||
2588586|NCT02304705|Other Pre-specified|Change in Pulmonary Vascular Resistance|Pulmonary vascular resistance will be determined by right heart catheterization. Data will be collected at baseline and at the end of treatment (90 days)|Baseline and 90 days|||||||
2588587|NCT02304705|Other Pre-specified|Change in Cardiac Output Relative to Body Surface Area (Cardiac Index)|cardiac output will be calculated by multiplying stroke volume by heart rate. Cardiac index will be calculated by dividing cardiac output (Liters/minute) by body surface area (meters squared). Data will be collected at baseline and the end of treatment (90 days)|Baseline and 90 days|||||||
2588588|NCT02304705|Other Pre-specified|Change in Right Ventricular Function|Right ventricular function will be measured using tricuspid annular plane systolic excursion via two dimensional apical four-chamber echocardiography. Data will be collected at baseline and after 90 days of treatment|Baseline and 90 day|||||||
2588589|NCT02304705|Primary|Change in Exercise Tolerance|In a controlled laboratory environment, participants will be asked to walk on a treadmill as fast as they can for 6 minutes. The test will be conducted at baseline and after 90 days of treatment. Data will be presented as the change in distance (in feet) walked in 6 minutes between baseline and treatment.|Baseline and 90 days|Several participants were not analyzed for several reasons including death, failure to follow-up, PI withdrawal or subject withdrawal. In the Sildenafil group, 17 participants were consented while 10 were analyzed. In the Placebo group, 16 subjects were consented and 12 were analyzed.|||feet||Standard Error|Mean
2588590|NCT02304484|Secondary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)||Baseline (of study 20120153) and weeks 0, 4, 12, 24, 36, 48, 52, 76, and 104 of study 20140128|Enrolled participants with available data at each time point|||percent change||Standard Deviation|Mean
2588591|NCT02304484|Primary|Number of Participants With Adverse Events|"The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe or medically significant AE, Grade 4 = Life-threatening consequences, and Grade 5 = death related to AE.~An adverse device effect was defined as any adverse event related to the use of a medical device (autoinjector/pen or automated mini doser [AMD]), including but not limited to, AEs resulting from insufficient or inadequate Instructions for Use, AEs resulting from any malfunction of the device, or AEs resulting from use error or from intentional misuse of the device."|From first dose of evolocumab up to 30 days after the last dose, or end of study, whichever was earlier, up to 108 weeks.|All enrolled participants|||Participants|||Count of Participants
2588592|NCT02304432|Secondary|Auditory Evoked Potentials - P50 Ratio (P50 S2/S1) (Amplitude)|Auditory evoked potential amplitude: P50 ratio (P50 S2/S1)|Baseline and Week 8 of DCS treatment|Only one subject had normal hearing, which is required for valid data collection.|||ratio|||Number
2588593|NCT02304432|Secondary|Auditory Evoked Potentials in Gamma Oscillations (the Power Spectrum is Measured in Microvolts Squared)|Auditory evoked potential gamma: G40 hz phase locking at fz and cz; G30 hz phase locking at fz and cz; G20 hz phase locking at fz and cz|Baseline and Week 8 of DCS treatment|Only one subject had normal hearing, which is required for valid data collection.|||microvolts squared|||Number
2588594|NCT02304432|Secondary|Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts)|Auditory evoked potential amplitude: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz; P50 S1 and S2; mismatch negativity (MMN) at fz and cz.|Baseline and Week 8 of DCS treatment|Only one subject had normal hearing, which is required for valid data collection.|||microvolts|||Number
2588595|NCT02304432|Secondary|Auditory Evoked Potentials in Latency (Msec)|Auditory evoked potential latency: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz.|Baseline and Week 8 of DCS treatment|Only one subject had normal hearing, which is required for valid data collection.|||msec|||Number
2588596|NCT02304432|Secondary|Brain Glycine/CR Ratio|Proton magnetic resonance spectroscopy at 4T: brain glycine/CR ratio. Participants were assessed at baseline (pre-glycine challenge dose and 60, 80, 100 and 120 minutes post glycine dose) and in week 8 of of open-label DCS treatment: pre-DCS dose, and 60, 80, 100 and 120 minutes post DCS dose. Measured in posterior occipital cortex.|Baseline and Week 8 of DCS treatment|Data collected only during only one of the open label periods for financial and logistical reasons. Data were collected in week 8 of the first open-label DCS exposure in one subject and in week 8 of the second open-label DCS exposure in the other subject for logistical reasons.|||ratio||Full Range|Median
2588610|NCT02304406|Secondary|Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Epidermal Growth Factor Receptor (EGFR) Status|In this outcome measure EGFR status of participants were evaluable for not tested, wild type and mutant.|3 years|"FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories."|||percentage of participants|||Number
2588597|NCT02304432|Secondary|Neurocognitive Function|Scores on each of 8 domains of cognitive function (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning/problem solving, social cognition, overall composite). Scores are T scores ranging from 0-100, with 50 representing the mean for a population based on a normal distribution, standard deviation of 10. Higher scores signify better functioning.|Baseline and Week 8 of open-label DCS treatment|The on DCS data were collected during week 8 of the first open-label portion of the study in one subject and in week 8 of the second open-label portion of the study in the other subject for logistical reasons.|||T scores||Full Range|Median
2588598|NCT02304432|Primary|Depression Symptom Scores|Hamilton Depression Scale (HAM) measures severity of depression symptoms. The sum of the ratings for 9 depression symptoms is measured on a scale of 0-2 with 0 meaning no depression symptoms and 2 meaning some level of severity of that specific symptom. The rating for one depression symptom is measured on a scale of 0-3 with 0 meaning no depression symptoms and 3 meaning a severe level of that specific symptom. The sum of ratings for 11 depression symptoms is measured on a scale of 0-4, with 0 meaning no symptoms and 4 meaning a severe level of that specific symptom. The three sums are added to produce an overall depression rating scale score ranging from 0-65. Higher scores indicate worse depression symptoms.|Baseline, 2, 4, & 6 weeks (crossover periods)||||units on a scale|||Number
2588599|NCT02304432|Primary|Mania Symptom Scores|Young Mania Rating Scale (YMRS) measures severity of manic symptoms. The sum of the ratings for 7 symptoms of mania is measured on a scale of 0-4 and the sumof 4 symptoms of mania is measured on a scale of 0-8 to yield a total score ranging from 0-60, with 0 meaning no manic symptoms and 60 meaning severe manic symptoms.|Baseline, 2, 4, & 6 weeks (crossover periods)||||units on a scale|||Number
2588600|NCT02304432|Primary|Depression Symptom Scores|Hamilton Depression Scale (HAM) measures severity of depression symptoms. The sum of the ratings for 9 depression symptoms is measured on a scale of 0-2 with 0 meaning no depression symptoms and 2 meaning some level of severity of that specific symptom. The rating for one depression symptom is measured on a scale of 0-3 with 0 meaning no depression symptoms and 3 meaning a severe level of that specific symptom. The sum of ratings for 11 depression symptoms is measured on a scale of 0-4, with 0 meaning no symptoms and 4 meaning a severe level of that specific symptom. The three sums are added to produce an overall depression rating scale score ranging from 0-65. Higher scores indicate worse depression symptoms.|Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2||||units on a scale||Full Range|Median
2588601|NCT02304432|Primary|Mania Symptom Scores|Young Mania Rating Scale (YMRS) measures severity of manic symptoms. The sum of the ratings for 7 symptoms of mania is measured on a scale of 0-4 and the sumof 4 symptoms of mania is measured on a scale of 0-8 to yield a total score ranging from 0-60, with 0 meaning no manic symptoms and 60 meaning severe manic symptoms.|Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2||||units on a scale||Full Range|Median
2588602|NCT02304432|Primary|Clinical Global Impression (CGI) Severity Scores|CGI severity scores measure severity of mental illness on a scale of 1-7 where 1 means normal, not at all ill, 2 means borderline mentally ill, 3 means mildly ill, 4 means moderately ill, 5 means markedly ill, 6 means severely ill and 7 means among the most extremely ill patients.|Baseline, 2, 4, & 6 weeks (crossover periods)||||units on a scale|||Number
2588603|NCT02304432|Primary|Clinical Global Impression (CGI) Severity Scores|CGI severity scores measure severity of mental illness on a scale of 1-7 where 1 means normal, not at all ill, 2 means borderline mentally ill, 3 means mildly ill, 4 means moderately ill, 5 means markedly ill, 6 means severely ill and 7 means among the most extremely ill patients.|Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2||||units on a scale||Full Range|Median
2588604|NCT02304432|Primary|Brief Psychiatric Rating Scale (BPRS) Scores|Total BPRS score measures severity of 18 psychiatric symptoms. Each symptom is scored 1-7 with the total score ranging from 18-126. 18 means no symptoms and 126 means very severe symptoms.|Baseline, 2, 4, & 6 weeks (crossover periods)||||units on a scale|||Number
2588605|NCT02304432|Primary|Brief Psychiatric Rating Scale (BPRS) Scores|Total BPRS score measures severity of 18 psychiatric symptoms. Each symptom is scored 1-7 with the total score ranging from 18-126. 18 means no symptoms and 126 means very severe symptoms.|Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2||||units on a scale||Full Range|Median
2588606|NCT02304432|Primary|Positive and Negative Symptom Scores|Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.The sum of ratings for seven negative symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.|Baseline, 2, 4, & 6 weeks (crossover periods)||||units on a scale|||Number
2588607|NCT02304432|Primary|Positive and Negative Symptom Scores|Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.The sum of ratings for seven negative symptoms is measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.|Baseline & at 2, 4, 6 & 8 Weeks during open-label phase 1 and every 2 weeks up to 24 weeks during open label phase 2||||units on a scale||Full Range|Median
2588608|NCT02304406|Secondary|Percentage Agreement Between Vysis Fluorescent In Situ Hybridization (FISH) and Ventana Immunohistochemistry (IHC) Methods for ALK Rearrangement Detection|Percent overall agreement between Vysis ALK-FISH and Ventana ALK IHC tests and its 95% CI is reported in this outcome measure.|3 years|"FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||percentage agreement||95% Confidence Interval|Number
2588609|NCT02304406|Secondary|Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Knowledge Representation for Autonomous Systems (KRAS) Status|In this outcome measure KRAS status of participants were evaluable for not tested, wild type, and mutant.|3 years|"FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories."|||percentage of participants|||Number
2602924|NCT02137603|Secondary|Thirty Day Complication Rate|Superficial wound infection, deep organ space infection, ileus or bowel obstruction requiring hospitalization or re-operation|Thirty days||||participants|||Number
2588611|NCT02304406|Secondary|Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Participant's Status|In this outcome measure participant's status at the time of sampling were evaluable for treatment-naive and treated.|3 years|"FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories."|||percentage of participants|||Number
2588612|NCT02304406|Secondary|Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Overall Response (OR)|Percentage of participants with best overall response. Complete response (CR) is equal to (=) disappearance of all target lesions. Partial Response (PR) = greater than equal to (>=) 30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD) >= 20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of >= 1 new lesion. Stable disease (SD) =neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|3 years|"FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories."|||percentage of participants|||Number
2588613|NCT02304406|Secondary|Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Line of Therapy|In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the line of therapy of study participants.|3 years|"FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories."|||percentage of participants|||Number
2588614|NCT02304406|Secondary|Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Progression Free Survival (PFS)|In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the PFS of study participants.|3 years|"FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2588615|NCT02304406|Secondary|Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Treatment Type|In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the treatment type of study participants.|3 years|"FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories."|||percentage of participants|||Number
2588616|NCT02304406|Secondary|Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Stage|In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the tumor stage of study participants.|3 years|"FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories."|||percentage of participants|||Number
2588617|NCT02304406|Secondary|Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Tumor Histologic Diagnosis|In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the diagnosis of tumor histology of study participants.|3 years|"FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories."|||percentage of participants|||Number
2588618|NCT02304406|Secondary|Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking History|In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the smoking history of study participants as participants who never smoked, current smoker and ex-smoker.|3 years|"FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories."|||percentage of participants|||Number
2588619|NCT02304406|Secondary|Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Race|In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the race of study participants.|3 years|"FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories."|||percentage of participants|||Number
2588620|NCT02304406|Secondary|Percentage of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender|In this outcome measure, percentage of participants with association of ALK rearrangement were evaluated and categorized in terms of the gender of study participants.|3 years|"FAS. Here, Overall Number of Participants Analyzed signifies participants who were evaluable for this outcome measure and number analyzed signifies the participants evaluable at specific categories."|||percentage of participants|||Number
2588621|NCT02304406|Primary|Percentage of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Rearrangement|Participants with prevalence of ALK rearrangement were positive for ALK: defined as presence of strong granular cytoplasmic staining in tumor cells (any percentage of positive tumor cells).|3 years|Full analysis set (FAS).|||percentage of participants||95% Confidence Interval|Number
2588622|NCT02304159|Primary|Number of Participants With Undetectable HCV Virus 12 Weeks After Stopping Study Drugs|Sustained Virologic Response (SVR) defined as undetectable HCV RNA 12 weeks after stopping study drugs.|From baseline (start of study drugs) until 12 weeks after stopping study drugs|The analysis covers only the subjects who reached the 12 weeks after stopping study drugs time point. 19 of 21 participants randomized to Group A reached that timepoint and 16 of 18 participants randomized to Group B reached that timepoint.|||Participants|||Count of Participants
2588623|NCT02304159|Primary|Number of Participants With Abnormal Safety Laboratory Tests (ALT and/or Total Bilirubin) That Required Discontinuing Study Drugs|This field states the number of participants who had an abnormal ALT that required discontinuing study drugs and/or abnormal Total Bilirubin that required discontinuing study drugs.|From baseline (start of study drugs) to last day of taking study drugs; an average of 20 weeks.||||Participants|||Count of Participants
2588625|NCT02303743|Secondary|Patient Satisfaction Were Assessed With a Specific Questionnaire|"Patient satisfaction were assessed with a specific questionnaire before colonoscopy. Patients were asked if they used the application and their satisfaction with the app. Again, the endoscopist was blinded to the answers. The items read as follows: (1) Do you have experience with a previous colonoscopy?; (2) Have you used the phone application?; (3) How easy was the preparation for colonoscopy?; (4) Which is your level of satisfaction with the bowel preparation?; (5) Would you like to repeat the same preparation in the future?; (6) Did you have any difficulty with the preparation?. Patient responses to the questionnaire were categorical (yes or no; questions 1, 2, 5, and 6) or numerical scale answers (0 to 10), from very difficult or very bad (0 or close to 0) to very easy or very good (10 or close to 10) (items 3 and 4)."|Day 1||||units on a scale||Standard Deviation|Mean
2588626|NCT02303743|Primary|Bowel Preparation Was Evaluated Using the Harefield Cleansing Scale (HCS). The Scale Was the Primary Outcome Measure|The quality of bowel cleansing is evaluated after colonoscopy (Day 1). Baseline the patients initiated low fiber diet in the 24 hours prior to colonoscopy. The HCS uses a 5-point qualitative scale in 5 separate colon segments. HCS is the sum of 5 segments, ranging from 0 (worst possible outcome) to 20 (best possible outcome). Global score assesses the quality of bowel cleansing: Successful (A or B) / unsuccessful (C or D). A: All segments scored 3 or 4; B: One or more segments scored 2; C: One or more segments scored 1; and D: One or more segments scored 0.|Day 1||||units on a scale||Standard Deviation|Mean
2588627|NCT02303704|Secondary|Operative Mortality|Deaths due to surgical complication during or after surgery.|Within 30 days after surgical Procedure|all patients who underwent surgery and monitored for death due to surgical complication.|||participants|||Number
2588628|NCT02303704|Secondary|Intra-aortic Balloon Pump Counter-pulsation (IABPC) Support|The need of IABPC (mechanical support) before surgery or during weaning from Cardiopulmonary bypass and in ICU to assist in maintaining hemodynamics of the patient.|24 hours before surgery and upto 1 week of surgical procedure.|All patients who underwent surgery and for whom IABP support was required.|||participants|||Number
2588629|NCT02303704|Secondary|Pharamacological Inotropic Support (Dobutamine)|The Need, Dose and duration of Dobutamine to maintain hemodynamic stability after surgery.|Upto 1 week after sugery|All patients in whom Dobutamine was used to wean off the patients from Cardiopulmonary Bypass.|||ug/kg/min||Standard Deviation|Mean
2588630|NCT02303704|Secondary|Pharmacological Inotropic Support (Nor-adrenaline)|The need, dose and duration of Nor-adrenaline infusion to maintain hemodynamic stability after surgery.|Upto 1 week after sugery|All patients in whom Nor-adrenaline was used to wean off the patients from Cardiopulmonary Bypass.|||ug/kg/min||Standard Deviation|Mean
2588631|NCT02303704|Secondary|Pharmacologic Inotropic Support (Adrenaline)|The need, dose and duration of adrenaline infusion to maintain hemodynamic stability after surgery were noted.|Upto 1 week after sugery|All patients in whom Adrenaline was used to wean off the patients from Cardiopulmonary Bypass.|||ug/kg/min||Standard Deviation|Mean
2588632|NCT02303704|Primary|Post-op CK-MB Levels|CK-MB is a marker of Myocardial Damage.|36 hours after surgery.|All patients in whom Peak CKMB levels were noted within 24 hours after surgery|||IU/L||Standard Deviation|Mean
2588633|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of Urine PK (Renal Clearance From 0 to 48 Hours (CLR0-48)) Parameter for Part 2 - MAD|To assess Percentage of dose excreted unchanged into the urine from 0 to 48 hours (Cumfe0 48) for Part 2|Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Liter/hour||Standard Deviation|Mean
2588634|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of Urine PK (Percentage of Dose Excreted Unchanged Into the Urine From 0 to 48 Hours (Cumfe0 48)) Parameter for Part 2 - MAD|To assess Percentage of dose excreted unchanged into the urine from 0 to 48 hours (Cumfe0 48) for Part 2|Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Percentage of dose excreted unchanged||Standard Deviation|Mean
2588635|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of Urine PK (Cumulative Amount of Analyte Excreted From 0 to 48 Hours (CumAe0-48)) Parameter for Part 2 - MAD|To assess Cumulative amount of analyte excreted from 0 to 48 hours (CumAe0-48)) for Part 2|Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||nmol||Standard Deviation|Mean
2588636|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of Urine PK (Renal Clearance From 0 to 24 Hours (CLR0-24)) Parameter for Part 2 - MAD|To assess renal clearance from 0 to 24 hours (CLR0-24) for Part 2|Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Liter/hour||Standard Deviation|Mean
2588637|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of Urine PK (Percentage of Dose Excreted Unchanged Into the Urine From 0 to 24 Hours (Cumfe0-24)) Parameter for Part 2 - MAD|To assess percentage of dose excreted unchanged into the urine from 0 to 24 hours (Cumfe0 24) for Part 2|Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Percentage of dose excreted unchanged||Standard Deviation|Mean
2588638|NCT02303574|Secondary|Assessment of Absolute Neutrophil Count (ANC) in All Cohorts of Part 2|Absolute neutrophil count (ANC) was evaluated as part of the safety laboratory assessments and to evaluate the pharmacodynamics (PD) marker|At Day 12 (pre-dose, 6 hours and 12 hours)|All participants who receiving at least 1 dose of AZD7986 or placebo and who had at least 1 pre-dose and 1 post-dose measurement for either NE (NE1 or NE2), and who had no major protocol deviations thought to impact on the analysis of the PD data|||10^9 neutrophils/L||Standard Deviation|Mean
2588639|NCT02303574|Secondary|Assessment of Mean Normalized Relative Neutrophil Elastase (NE) Activity in All Cohorts of Part 2|Absolute neutrophil count (ANC) was evaluated as part of the safety laboratory assessments and to evaluate the pharmacodynamics (PD) marker|At Day 16, 21 ((last dosing day in Cohort 1), 25, 28 (last sampling day in Cohort 1 and last dosing day in Cohorts 2 and 3), 32, 38, 41 and 52|All participants who receiving at least 1 dose of AZD7986 or placebo and who had at least 1 pre-dose and 1 post-dose measurement for either NE (NE1 or NE2), and who had no major protocol deviations thought to impact on the analysis of the PD data|||Percentage change in NE activity||Standard Deviation|Mean
2588640|NCT02303574|Secondary|Effect of Food on Absorption AZD7986 by Assessment of the Apparent Volume of Distribution (Vz/F) for Part 1a and 1b - SAD|To assess the effect of food by evaluating the apparent volume of distribution (Vz/F) for Part 1a (fasted state) and 1b (fed state) - SAD; Vz/F at terminal phase (extravascular administration) was estimated by dividing the apparent clearance (CL/F) by λz|At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 hours); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Litre||Standard Deviation|Mean
2588641|NCT02303574|Secondary|Effect of Food on Absorption AZD7986 by Assessment of the Apparent Clearance (CL/F) for Part 1a and 1b - SAD|To assess the effect of food by evaluating the apparent clearance (CL/F) for Part 1a (fasted state) and 1b (fed state) - SAD; CL/F for parent drug was estimated as dose divided by AUC|At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 hours); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Litre/Hour||Standard Deviation|Mean
2588642|NCT02303574|Secondary|Effect of Food on Absorption AZD7986 by Assessment of the Mean Residence Time (MRT) for Part 1a and 1b - SAD|To assess the effect of food by evaluating the mean residence time (MRT) for Part 1a (fasted state) and 1b (fed state) - SAD|At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 hours); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Hour||Standard Deviation|Mean
2588643|NCT02303574|Secondary|Effect of Food on Absorption AZD7986 by Assessment of the Apparent Terminal Elimination Half-life (t½.λz) for Part 1a and 1b - SAD|To assess the effect of food by evaluating the half life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½.λz) for Part 1a (fasted state) and 1b (fed state) - SAD|At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 hours); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Hour||Standard Deviation|Mean
2588644|NCT02303574|Secondary|Effect of Food on Absorption AZD7986 by Assessment of the Time to Reach Maximum Observed Concentration (Tmax) for Part 1a and 1b - SAD|To assess the effect of food by evaluating the time to reach maximum observed concentration (tmax) for Part 1a (fasted state) and 1b (fed state) - SAD; tmax was taken directly from the individual concentration-time curve|At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 hours); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Hour||Full Range|Median
2588645|NCT02303574|Secondary|Effect of Food on Absorption AZD7986 by Assessment of the Observed Maximum Plasma Concentration (Cmax) for Part 1a and 1b - SAD|To assess the effect of food by evaluating the observed maximum plasma concentration (Cmax) for Part 1a (fasted state) and 1b (fed state) - SAD. Cmax was taken directly from the individual concentration-time curve|At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 hours); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2588646|NCT02303574|Secondary|Effect of Food on Absorption AZD7986 by Assessment of the Area Under Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC) for Part 1a and 1b - SAD|To assess the effect of food by evaluating the area under plasma concentration-time curve from zero extrapolated to infinity (AUC) for Part 1a (fasted state) and 1b (fed state) - SAD. AUC was estimated by AUC(0 last) + Clast/λz where Clast was the last observed quantifiable concentration.|At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 hours); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||h·nmol/L||Geometric Coefficient of Variation|Geometric Mean
2588647|NCT02303574|Secondary|Effect of Food on Absorption AZD7986 by Assessment of the Area Under the Plasma Concentration Versus Time Curve, From Time Zero to the Time of the Last Quantifiable Concentration (AUC(0-last)) for Part 1a and 1b - SAD|To assess the effect of food by evaluating the area under the plasma concentration versus time curve, from time zero to the time of the last quantifiable analyte concentration (AUC(0-last)) for Part 1a (fasted state) and 1b (fed state) - SAD|At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 hours); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||h·nmol/L||Geometric Coefficient of Variation|Geometric Mean
2588648|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of Urine PK (Cumulative Amount of Analyte Excreted From 0 to 24 Hours (CumAe0-24)) Parameters for Part 2 - MAD|To assess cumulative amount of analyte excreted from 0 to 24 hours (CumAe0-24) for Part 2|Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||nmol||Standard Deviation|Mean
2588699|NCT02302716|Secondary|Change From Baseline to 24 Weeks in Body Weight|Change from baseline in body weight. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.|Baseline, 24 Weeks|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline body weight measure.|||Kilogram (kg)||Standard Error|Least Squares Mean
2588649|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of Urine PK Parameter (Renal Clearance From 0 to 48 Hours (CLR0-48)) Following Administration of Single Dose Oral Solution for Part 1a and 1b - SAD|To assess renal clearance from 0 to 48 hours (CLR0-48) after single dose administration of AZD7986 oral solution in Part 1a (fasted state) and 1b (fed state)|At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Liter/hour||Standard Deviation|Mean
2588650|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of Urine PK Parameter (Percentage of Dose Excreted Unchanged Into the Urine From 0 to 48 Hours (Cumfe0-48)) Following Administration of Single Dose Oral Solution for Part 1a and 1b - SAD|To assess percentage of dose excreted unchanged into the urine from 0 to 48 hours (Cumfe0-48) after single dose administration of AZD7986 oral solution in Part 1a (fasted state) and 1b (fed state)|At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Percentage of dose excreted unchanged||Standard Deviation|Mean
2588651|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of Urine PK Parameter (Cumulative Amount of Analyte Excreted From 0 to 48 Hours (CumAe0-48)) Following Administration of Single Dose Oral Solution for Part 1a and 1b - SAD|To assess cumulative amount of analyte excreted from 0 to 48 hours (CumAe0-48) after single dose administration of AZD7986 oral solution in Part 1a (fasted state) and 1b (fed state)|At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||nmol||Standard Deviation|Mean
2588652|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of the Temporal Change Parameter (TCP) for Part 2 - MAD|To assess the temporal change parameter (TCP) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2; estimated as AUC(0-τ) Day 21/AUC Day 1, if extrapolated part was less than 20%|Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Ratio||Standard Deviation|Mean
2588653|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of the Accumulation Ratio for Cmax (Rac(Cmax)) for Part 2 - MAD|To assess the accumulation ratio for Cmax (Rac(Cmax)) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2; estimated as Cmax Day 21/Cmax Day 1|Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Ratio||Standard Deviation|Mean
2588654|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of the Accumulation Ratio for (Rac(AUC(0-τ)) for Part 2 - MAD|To assess the accumulation ratio for (Rac(AUC(0-τ)) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2; estimated as AUC(0-τ) Day 21/AUC(0-24) Day 1|Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Ratio||Standard Deviation|Mean
2588655|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of the Apparent Volume of Distribution (Vz/F) for Part 2 - MAD|To assess the the apparent volume of distribution (Vz/F) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2; Vz/F at terminal phase (extravascular administration) was estimated by dividing the apparent clearance (CL/F) by λz|Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Litre||Standard Deviation|Mean
2588656|NCT02303574|Primary|Rate and Extent of Absorption AZD7986 by Assessment of the Apparent Volume of Distribution (Vz/F) for Part 1a and 1b - SAD|To assess the apparent volume of distribution (Vz/F) for Part 1a (fasted state) and 1b (fed state) - SAD; Vz/F at terminal phase (extravascular administration) was estimated by dividing the apparent clearance (CL/F) by λz|At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Litre||Standard Deviation|Mean
2588657|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of the Apparent Clearance (CL/F) for Part 2 - MAD|To assess the apparent clearance (CL/F) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2; CL/F for parent drug was estimated as dose divided by AUC|Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Litre/Hour||Standard Deviation|Mean
2588658|NCT02303574|Primary|Rate and Extent of Absorption AZD7986 by Assessment of the Apparent Clearance (CL/F) for Part 1a and 1b - SAD|To assess the apparent clearance (CL/F) for Part 1a (fasted state) and 1b (fed state) - SAD; CL/F for parent drug was estimated as dose divided by AUC|At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Litre/Hour||Standard Deviation|Mean
2588715|NCT02302365|Other Pre-specified|Pre-procedure WBC Count|Pre-procedure WBC count|Prior to Each Spectra Optia Apheresis Procedure|The Full Analysis Set comprised all 43 patients (58 procedures) for whom WBCD data were collected.|||cells x 10^9/L|procedures|Standard Deviation|Mean
2588659|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of Mean Residence Time (MRT) for Part 2 - MAD|To assess the mean residence time (MRT) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2|Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Hour||Standard Deviation|Mean
2588660|NCT02303574|Primary|Rate and Extent of Absorption AZD7986 by Assessment of the Mean Residence Time (MRT) for Part 1a and 1b - SAD|To assess the mean residence time (MRT) for Part 1a (fasted state) and 1b (fed state) - SAD|At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Hour||Standard Deviation|Mean
2588661|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of the Apparent Terminal Elimination Half-life (t½.λz) for Part 2 - MAD|To assess the apparent terminal elimination half-life (t½.λz) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2; tmax was taken directly from the individual concentration-time curve. Note: Day 1 data were calculated over a 24 hour period and was therefore not comparable with the Day 21 and Day 28 data|Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Hour||Standard Deviation|Mean
2588662|NCT02303574|Primary|Rate and Extent of Absorption AZD7986 by Assessment of the Apparent Terminal Elimination Half-life (t½.λz) for Part 1a and 1b - SAD|To assess the half life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½.λz) for Part 1a (fasted state) and 1b (fed state) - SAD|At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Hour||Standard Deviation|Mean
2588663|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of the Time to Reach Maximum Observed Concentration (Tmax) for Part 2 - MAD|To assess the time to reach maximum observed concentration (tmax) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2; tmax was taken directly from the individual concentration-time curve|Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Hour||Full Range|Median
2588664|NCT02303574|Primary|Rate and Extent of Absorption AZD7986 by Assessment of the Time to Reach Maximum Observed Concentration (Tmax) for Part 1a and 1b - SAD|To assess the time to reach maximum observed concentration (tmax) for Part 1a (fasted state) and 1b (fed state) - SAD; tmax was taken directly from the individual concentration-time curve|At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||Hour||Full Range|Median
2588665|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of the Observed Maximum Plasma Concentration (Cmax) for Part 2 - MAD|To assessthe observed maximum plasma concentration (Cmax) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2. Cmax was taken directly from the individual concentration-time curve|Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2588666|NCT02303574|Primary|Rate and Extent of Absorption AZD7986 by Assessment of the Observed Maximum Plasma Concentration (Cmax) for Part 1a and 1b - SAD|To assess the observed maximum plasma concentration (Cmax) for Part 1a (fasted state) and 1b (fed state) - SAD. Cmax was taken directly from the individual concentration-time curve|At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2588667|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCτ) for Part 2 - MAD|To assess area under the plasma concentration-time curve from time zero to the end of the dosing interval (AUCτ) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2. AUCτ: AUC from time zero to 24 hours post-dose presented on Day1|Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||h·nmol/L||Geometric Coefficient of Variation|Geometric Mean
2588668|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of the Area Under Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC) for Part 2 - MAD|To assess the area under plasma concentration-time curve from zero extrapolated to infinity (AUC) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2. Note: Day 1 data calculated over a 24 hour period and was therefore not comparable with the Day 21 and Day 28 data|Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||h·nmol/L||Geometric Coefficient of Variation|Geometric Mean
2588821|NCT02301377|Secondary|Cystic Fibrosis Questionnaire-Revised (CFQ-R) Treatment Burden Domain Score (Parent)|Response of the parents/caregivers to the treatment burden domain of the CFQ-R at the end of 3-months|3 months||||units on a scale||Standard Deviation|Mean
2588669|NCT02303574|Primary|Rate and Extent of Absorption AZD7986 by Assessment of the Area Under Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC) for Part 1a and 1b - SAD|To assess the area under plasma concentration-time curve from zero extrapolated to infinity (AUC) for Part 1a (fasted state) and 1b (fed state) - SAD. AUC was estimated by AUC(0 last) + Clast/λz where Clast was the last observed quantifiable concentration.|At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||h·nmol/L||Geometric Coefficient of Variation|Geometric Mean
2588670|NCT02303574|Primary|Rate and Extent of Absorption of AZD7986 by Assessment of the Area Under the Plasma Concentration Versus Time Curve, From Time Zero to the Time of the Last Quantifiable Analyte Concentration (AUC(0-last)) for Part 2 - MAD|To assess the area under the plasma concentration versus time curve, from time zero to the time of the last quantifiable analyte concentration (AUC(0-last)) following a single AZD7986 dose on Day 1 and daily dosing on Days 21 or 28 at 10, 25 and 40 mg in Part 2|Day 1 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24 h); Day 21 (pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 9, 12, 24, 72, 96 h) and Day 28|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||h·nmol/L||Geometric Coefficient of Variation|Geometric Mean
2588671|NCT02303574|Primary|Rate and Extent of Absorption AZD7986 by Assessment of the Area Under the Plasma Concentration Versus Time Curve, From Time Zero to the Time of the Last Quantifiable Concentration (AUC(0-last)) for Part 1a and 1b - SAD|To assess the area under the plasma concentration versus time curve, from time zero to the time of the last quantifiable analyte concentration (AUC(0-last)) for Part 1a (fasted state) and 1b (fed state) - SAD|At Day 1 (Pre-dose, 0.5, 1, 2, 3, 4, 5, 7, 8, 9, 12 h); Day 2 (24 h); Day 3 (48 h); Day 4 (72 h) and Day 5 (96 h)|The pharmacokinetic analysis (PK) analysis set consisted of all subjects in the safety analysis set who received at least 1 dose of AZD7986 and had evaluable PK data.|||h·nmol/L||Geometric Coefficient of Variation|Geometric Mean
2588672|NCT02303574|Primary|Safety and Tolerability of AZD7986 by Assessment of the Number of Adverse Events (AEs) Following Administration of Oral Solution in Single Ascending Dose (SAD - Part 1a and 1b) and Multiple Ascending Doses (MAD -Part 2)|To investigate the safety and tolerability of AZD7986 by assessment of AEs (non-serious and serious) following administration of oral solution in SAD (Part 1a - fasted state and 1b - fed state) and MAD (Part 2)|Part 1a and 1b: Day -1, Day 1 to Day 3 (spontaneous, at pre-dose, 3, 12, 24, 48 and 72 hours [h] post-dose), Day 4, Day 5 and follow-up (7-10 days after dosing [not for participants included in Part 1b]); Part 2: Day -1, Day 1 to Day 21/28 and follow-up|All randomized subjects who received at least one dose of IMP were included in the safety analysis for the study.|||Participants|||Number
2588673|NCT02303548|Primary|Return of Spontaneous Circulation (ROSC)||checked during CPR, duration of ROSC >20 min||||percent|||Number
2588674|NCT02303262|Secondary|Progression Free Survival (PFS)|Progression free survival is defined as the time from treatment initiation to the earlier date of assessment of objective progression or death by any cause in the absence of progression. Progression Free Survival (PFS) is defined as the time from treatment initiation to the earlier date of assessment of objective progression or death by any cause in the absence of progression. Progression will be assessed by RECIST v. 1.1.|27 months||||months||95% Confidence Interval|Median
2588675|NCT02303262|Secondary|Duration of Response|The duration of objective response will be measured from the time measurement criteria are first met until disease progression is objectively documented.|27 months||||months||95% Confidence Interval|Median
2588676|NCT02303262|Primary|Response Rate (Per RECIST 1.1)|Response rate (CR or PR) will be calculated by the number of patients achieving a response divided by the number of patients having been evaluated for response. Per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR) is the disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameters of all target lesions.|27 months||||Participants|||Count of Participants
2588677|NCT02303041|Secondary|Gene Expression Profiles (Correlation of Particular Gene Expression Profiles and Response to LB Therapy Will be Assessed.)|"The gene expression profiles for Gli-1; Gli-2; Patched (Ptch) ; Suppressor of Fused (SuFu); Smoothened (Smo); and phosphatidylinositol-3-kinase (PI3K) were to be correlated to the clinical response to therapeutic therapy."|up to 2 years post-treatment|The individual samples were not analyzed for the biomarkers due to the overall small sample size, and thus the correlation of gene expression profile to therapeutic response was not conducted.||||||
2588678|NCT02303041|Secondary|Changes in Gene Expression Profiles of BCCs Including Hedgehog Pathway and PI3K Pathways|"Immunostaining for the Gli-1; Gli-2; Patched (Ptch) ; Suppressor of Fused (SuFu); Smoothened (Smo); and phosphatidylinositol-3-kinase (PI3K) cellular biomarkers were to be contacted at baseline and after 12 weeks of treatment."|Baseline to 2 years|The individual samples were not analyzed for the biomarkers due to the overall small sample size.||||||
2588679|NCT02303041|Secondary|Adverse Event Frequency|Adverse events, graded according to the National Cancer Institute CTCAE version 3.0, are reported by treatment arm in total and by Grade 1 to 5.|Up to 30 days post-treatment||||adverse events|||Number
2588680|NCT02303041|Secondary|Median Duration of Response|"Response per the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria was monitored for duration of response (DOR)~Complete Response (CR) = Disappearance of all target lesions~Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions~Overall Response (OR) = CR + PR~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions~Stable disease (SD) = Small changes that do not meet any of the above criteria"|up to 12 weeks|Most participants were not evaluable per protocol.|||months||Full Range|Median
2588681|NCT02303041|Primary|Overall Response Rate (ORR)|"Response was assessed by the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria, and reported as overall response rate (ORR), comprised of the sum of complete response (CR) rate and partial response (PR) rate.~Complete Response (CR) = Disappearance of all target lesions~Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions~Overall Response (OR) = CR + PR"|Up to 2 years||||Participants|||Count of Participants
2588822|NCT02301377|Secondary|Cystic Fibrosis Questionnaire-Revised (CFQ-R)Treatment Burden Domain Score (Child)|Response of the participants to the treatment burden domain of the CFQ-R at the end of 3 months|3 months||||units on a scale||Standard Deviation|Mean
2588682|NCT02302859|Primary|Smoking Abstinence: 3-month Assessment Via Smart Phone|Smoking abstinence defined as number of participants with biochemically 7-day abstinence confirmed with weekly smart-phone assessments. Saliva cotinine levels, assessed with NicAlert test strips, used to biochemically verify abstinence. Participants will complete the NicAlert saliva cotinine test (supplies given at enrollment) and take a photograph of the test strip results. In primary abstinence analysis for difference in cessation rate between interventions, participants who do not complete follow-up assessments considered to be smokers.|3 months|Data were not collected due to early termination of the protocol||||||
2588683|NCT02302846|Primary|Relapse-Free Survival (RFS)|RFS defined as interval from date of enrollment to date of first objective documentation of disease relapse or death from any cause. Survival or times to failure and time to progression functions estimated using Kaplan-Meier method.|84 days|Three participants were evaluable for response. One patient was evaluable for toxicity only. No other analysis is possible due to the low number of patients accrued.|||Weeks||Full Range|Median
2588684|NCT02302807|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Fatigue Symptom Scale|The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). Key scales included physical functioning, and fatigue, and GHS.|Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)|All randomized patients with non-missing baseline assessment and at least one non-missing post-baseline assessment.|||units of a scale||Standard Deviation|Mean
2588685|NCT02302807|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Physical Functioning Scale|The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). Key scales included physical functioning, and fatigue, and GHS.|Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)|All randomized patients with non-missing baseline assessment and at least one non-missing post-baseline assessment.|||units of a scale||Standard Deviation|Mean
2588686|NCT02302807|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Global Health Status Scale|The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). Key scales included physical functioning, and fatigue, and GHS.|Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)|All randomized patients with non-missing baseline assessment and at least one non-missing post-baseline assessment.|||units of a scale||Standard Deviation|Mean
2588687|NCT02302807|Secondary|Maximum Observed Serum Atezolizumab Concentration (Cmax)|Cmax was measured for all participants that received at least one dose of Atezolizumab.|30 minutes post dose on Day 1 of Cycles 1|The PK-evaluable population is defined as patients who received atezolizumab treatment and had at least one measureable PK concentration.|||mcg/mL||Standard Deviation|Geometric Mean
2588688|NCT02302807|Secondary|Percentage of Participants With Unconfirmed Objective Response Rate (ORR) as Determined by the Investigator With Use of Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)|ORR was defined as the percentage of participants, who had an objective response. Objective response was defined as either a complete response (CR) or partial response (PR) as determined by the investigator with use of Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). Objective response in this study did not need to be a confirmed response. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. ORR=CR+PR|Up to approximately 25 months after first participant enrolled|ORR analyses was performed on all randomized patients who had measureable disease at baseline|||Percentage of participants||95% Confidence Interval|Number
2588689|NCT02302807|Secondary|Minimum Observed Serum Atezolizumab Concentration (Cmin)|Cmin was measured for all participants that received at least one dose of Atezolizumab.|Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)|The PK-evaluable population is defined as patients who received atezolizumab treatment and had at least one measureable PK concentration.|||mcg/mL||Standard Deviation|Geometric Mean
2588690|NCT02302807|Secondary|Percentage of Participants With Post-Baseline Anti-therapeutic Antibodies (ATA) to Atezolizumab|Participants were considered post-baseline ATA positive if they had post-baseline ATAs to Atezolizumab that were treatment-induced or treatment-enhanced. Participants had treatment-induced ATAs if they had a baseline-negative ATA result and developed ATAs at any time after initial drug administration. Participants had treatment-enhanced ATAs if they had a baseline-positive ATA result that showed an enhanced signal that was >/= 0.60 titer units at any time after initial drug initiation.|Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4 and every 8 cycles thereafter; at treatment discontinuation (up to 25 months); at 120 days after last dose of atezolizumab (up to 25 months; each cycle is 21 days)|ATA evaluable population is defined as patients who received atezolizumab treatment and had at least one post-treatment ATA result.|||percentage of participants|||Number
2590390|NCT02284464|Secondary|Number of Participants With Acute Rejection Lesions|Patients with acute rejection lesions (including subclinical rejection) at 24 months according to Banff classification|24 months||||Participants|||Count of Participants
2588691|NCT02302807|Secondary|Percentage of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to approximately 46 months after first participant enrolled|Safety analyses was performed on all randomized patients who received any amount of study treatment, with patients grouped according to whether any amount of atezolizumab was received including the case when atezolizumab was received in error.|||percentage|||Number
2588692|NCT02302807|Secondary|Unconfirmed Duration of Response (DOR) as Determined by the Investigator With Use of RECIST v1.1|DOR was defined as the time from first occurrence of a CR or PR, whichever came first, to first documented PD or death, whichever occurred first. Disease progression was determined on the basis of investigator assessment with use of RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm.|Up to approximately 25 months after first participant enrolled|DOR analyses was performed on the subset of patients who achieved an objective response.|||months||95% Confidence Interval|Median
2588693|NCT02302807|Secondary|Progression-free Survival (PFS) as Determined by the Investigator With Use of RECIST v1.1|PFS was defined as the time between the date of randomization and the date of first documented progression of disease (PD) or death, whichever occurred first. PD was determined on the basis of investigator assessment with use of RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters had to demonstrate an absolute increase of >/= 5 millimeters (mm).|Up to approximately 25 months after first participant enrolled|Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received.|||months||95% Confidence Interval|Median
2588694|NCT02302807|Primary|Overall Survival (OS)|OS was defined as time from randomization to death from any cause.|Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled|Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received.|||Months||95% Confidence Interval|Median
2588695|NCT02302716|Secondary|Percentage of Participants With Hypoglycemic Events|The percentage of participants (with at least 1 hypoglycemic event (total, severe, nocturnal, and others) or incidence during the study was analyzed using Fisher's exact test. A hypoglycemic event is defined as any time a participant has a blood glucose (BG) level of ≤70 milligrams per deciliter (mg/dL) even if the event was not associated with signs, symptoms, or treatment consistent with current guidelines (American Diabetes Association 2005). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions. Severe Hypoglycemic events may or may not have a reported BG ≤70 mg/dL. These events may be associated with sufficient neuroglycopenia to induce seizure or coma.|Endpoint [up to 24 weeks]|All randomized participants who had a post-baseline measurement for Hypoglycemic Events; last observation carried forward (LOCF).|||Percentage of participants|||Number
2588696|NCT02302716|Secondary|Rate of Hypoglycemic Events Adjusted Per 1 Year|The rate of hypoglycemic events were analyzed at baseline, titration, maintenance, and overall study periods and at endpoint using the Wilcoxon test. In addition, a negative binomial model was used as a sensitivity analysis. A hypoglycemic event is defined as any time a participant has a blood glucose (BG) level of ≤70 milligrams per deciliter (mg/dL) even if the event was not associated with signs, symptoms, or treatment consistent with current guidelines (American Diabetes Association 2005). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions. Severe Hypoglycemic events may or may not have a reported BG ≤70 mg/dL. These events may be associated with sufficient neuroglycopenia to induce seizure or coma.|Baseline through Endpoint [up to 24 weeks]|All randomized participants who received at 1 dose of study drug with Baseline at least 1 post-Baseline hypoglycemic event; last observation carried forward (LOCF).|||Hypoglycemic events per 1 year||Standard Deviation|Mean
2588697|NCT02302716|Secondary|Percentage of Participants With Detectable Anti-Drug Antibodies to LY2963016 or LANTUS®|The percentage of participants with detected insulin antibodies were summarized as counts and percentages at baseline, at each visit, at the 24-week endpoint (LOCF), and overall for the 24-week treatment period.|Endpoint [up to 24 weeks]|All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline with detectable anti-drug antibodies; last observation carried forward (LOCF).|||Percentage of participants|||Number
2588698|NCT02302716|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ) Score|ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen [(IR) 5 items: domain scores range (DSR) 5-35], Lifestyle Flexibility [(LF) 3 items: DSR 3-21], Glycemic Control [(GC) 3 items: DSR 3-21], Hypoglycemic Control [(HC) 5 items: DSR 5-35], Insulin Delivery Device [(IDD) 6 items: DSR 6-42]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100*[(7-mean raw score)/6]. Higher scores indicate better treatment satisfaction. LS means was determined by MMRM with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.|Week 4 and Week 24|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline ITSQ measure.|||units on a scale||Standard Error|Least Squares Mean
2588700|NCT02302716|Secondary|Basal Insulin Dose Per Body Weight (U/kg/Day)|Basal Insulin dose in units (U) per body weight in kilograms (kg) per day. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.|Week 24|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline Basal Insulin Dose per Body Weight measure.|||units per kilogram per day (U/kg/day)||Standard Error|Least Squares Mean
2588701|NCT02302716|Secondary|Basal Insulin Dose Units Per Day|Units of Basal Insulin dose taken per day (U/day). Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline of response, baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.|Week 24|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline Basal Insulin Dose.|||Units per day (U/day)||Standard Error|Least Squares Mean
2588702|NCT02302716|Secondary|Intra-Participant Variability in Fasting Blood Glucose (FBG)|Fasting blood glucose (FBG) is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Intra-Participant FBG variability was calculated based on the standard deviation (SD) of the morning pre-meal BG value. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.|Week 24|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline fasting blood glucose measure.|||mmol/L||Standard Error|Least Squares Mean
2588703|NCT02302716|Secondary|Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values|Seven-point SMBG are completed at the following timepoints: Before Morning Meal, 2 Hours After Morning Meal, Before Mid-Day Meal, 2 Hours After Mid-Day Meal, Before Evening Meal, Bed Time and 03:00 AM hours. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with baseline HbA1c, country, sulfonylurea use, basal insulin status at study entry, visit, treatment and visit*treatment in the model.|Baseline, Week 24|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline SMBG measure.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2588704|NCT02302716|Secondary|Percentage of Participants With HbA1c <7% and ≤6.5%|Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.|Endpoint [up to 24 weeks]|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline HbA1c measure; last observation carried forward (LOCF).|||Percentage of participants|||Number
2588705|NCT02302716|Primary|Change From Baseline to 24 Weeks in Hemoglobin A1c (HbA1c)|"HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.~Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, treatment (LY2963016, LANTUS), pooled country, basal insulin at entry (yes/no), sulfonylurea (SU) use (yes/no), visit, treatment and visit*treatment in the model."|Baseline, 24 weeks|All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline HbA1c measure.|||Percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2588706|NCT02302365|Other Pre-specified|Waste Bag Volume|Volume of the depletion product|Post each Spectra Optia Apheresis Procedure|Full and Safety Analysis Sets; One patient terminated the first procedure prematurely, resulting in a total of 57 units analyzed.|||mL|procedures|Standard Deviation|Mean
2588707|NCT02302365|Other Pre-specified|Platelet Change (% Change)|% change in patient's pre and post-depletion procedure platelet counts|Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Data were collected on a total of 58 procedures, however one patient terminated her first procedure prematurely and therefore did not have post-procedure data.|||percent change|procedures|Standard Deviation|Mean
2588708|NCT02302365|Other Pre-specified|Procedure Duration|The duration of the WBCD procedure measured in minutes|Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Sets|||minutes|procedures|Standard Deviation|Mean
2588709|NCT02302365|Other Pre-specified|Whole Blood Flow mL/Min|Whole Blood Flow in mL/min measured during the white blood cell depletion procedure|Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Set|||mL/min|procedures|Standard Deviation|Mean
2588710|NCT02302365|Post-Hoc|Total Blood Volumes (TBV) Processed|Number of times the patient's TBV was processed during the apheresis procedure based on the patient's estimated TBV (Estimated by Nadler's formula for total blood volume of a human being based on gender, height, and weight).|Post each Spectra Optia Apheresis Procedure|Full and Safety Analysis Sets|||TBV|procedures|Standard Deviation|Mean
2588711|NCT02302365|Other Pre-specified|Whole Blood Processed (mL)|Volume of patient's blood processed in mL during the apheresis procedure|Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Sets|||mL|procedures|Standard Deviation|Mean
2588712|NCT02302365|Other Pre-specified|Patient's Platelet Count Post-depletion Procedure|Patient's platelet count post-depletion procedure|Participants were followed for the duration of the procedure and for up to 2 hours after the procedure, an average of 6 hours.|Full and Safety Analysis Sets. Data were collected on a total of 58 procedures, however one patient terminated her first procedure prematurely and therefore did not have post-procedure data.|||cells x 10^3/L|procedures|Standard Deviation|Mean
2588713|NCT02302365|Other Pre-specified|Patient's Platelet Count Pre-depletion Procedure|Patient's platelet count pre-depletion procedure|Prior to Each Spectra Optia Apheresis Procedure|Full and Safety Analysis Sets.|||cells x 10^3/L|procedures|Standard Deviation|Mean
2588714|NCT02302365|Other Pre-specified|Post-procedure WBC Count|Post-procedure WBC count|Following apheresis procedure|Data were collected on a total of 58 procedures, however one patient terminated the first procedure prematurely and therefore did not have post-procedure data.|||cells x 10^9/L|procedure|Standard Deviation|Mean
2590950|NCT02277665|Primary|Initiation of Nicotine Replacement Therapy (NRT)|# of participants who initiated NRT during the 24 week study period|24 weeks|All participants included in analysis|||Participants|||Count of Participants
2588716|NCT02302365|Primary|Adverse Events|Adverse events were defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medical device, whether or not considered related to the medical device and/or procedure. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the medical device and/or procedure.|Participants were followed for the duration of the procedure and for up to 24 hours after the procedure.|Full and Safety Analysis Sets. 53.5% of subjects with acute myeloid leukemia (AML), 18.6% of subjects with chronic lymphocytic leukemia, < 10% of subjects with other diagnoses. The WBCD procedure was performed most frequently to treat leukocytosis (44.2%), to prevent tumor lysis syndrome (34.9%), or to treat increased blood viscosity (20.9%).|||Number of subjects with at least 1 TEAE|||Number
2588717|NCT02302365|Primary|Collection Efficiency (CE) for WBC (or Percent of Processed WBCs) Achieved by Spectra Optia.|Collection efficiency for WBC achieved by Spectra Optia System calculation: (WBC/µL depletion product x depletion product volume) / (WBCpre + WBCpost) / 2 x total processed blood volume)|immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure|The CE of the WBCD procedures was measured from the waste bag (depletion product) contents from Sites 2 and 3. WBC counts were not available from the waste bags for subjects treated at Site 1.|||percent of processed WBCs|procedures|Standard Deviation|Mean
2588718|NCT02302365|Primary|Percent Decrease in White Blood Cell Count in Patient Following Apheresis Procedure|Percent decrease in WBC count calculation: (WBCpre - WBCpost) / WBCpre x 100%|immediately after apheresis procedure: on average this will be within 15 minutes after the end of the procedure|The Full Analysis Set comprised all 43 patients (58 procedures) for whom WBCD data were collected. One patient terminated the first procedure prematurely and therefore did not have post-procedure data, resulting in a total of 57 units analyzed.|||% change in subject's WBC count|procedures|Standard Deviation|Mean
2588719|NCT02302339|Secondary|Adverse Events|The percentage of patients experiencing one or more AEs will be summarized by relationship to study drug and severity.|Following at least one dose of study treatment through 28 days after last dose of glembatumumab vedotin, or 70 calendar days after last administration of varlilumab, CDX-301 or PD-1 targeted checkpoint inhibitor (whichever occurs latest)||||Participants|||Count of Participants
2588720|NCT02302339|Secondary|Correlation of Activity to gpNMB Expression|To investigate if the anti-cancer activity of glembatumumab vedotin as monotherapy or in combination with immunotherapies in advanced melanoma is dependent upon the degree of gpNMB expression in tumor tissue.|Up to 18 months following the screening visit|Analysis not completed. gpNMB expression in tumor tissue was not done.||||||
2588721|NCT02302339|Secondary|Overall Survival (OS)|Overall Survival (OS) is defined as the number of months from randomization to the date of death due to any cause.|During treatment and every 3 months from end of treatment through death or end of study|Response evaluable (at least one dose and a post treatment disease assessment). The analysis was not completed for the glembatumumab + CDX-301 cohort or the glembatumumab vedotin and PD-1 targeted checkpoint inhibitor cohort because sufficient data were not collected to perform the analysis.|||months||95% Confidence Interval|Median
2588722|NCT02302339|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or progression in a non-target lesion, or the appearance of new lesions.|Evaluated every 6 to 9 weeks following treatment initiation until progression.|Response evaluable (at least one dose and a post treatment disease assessment). The analysis was not completed for the glembatumumab + CDX-301 cohort because sufficient data were not collected to perform the analysis.|||months||95% Confidence Interval|Median
2588723|NCT02302339|Secondary|Duration of Response (DOR)|DOR is the number of months from the time criteria are first met for either CR or PR, until the first date that PD is objectively documented per RECIST 1.1.|From start date of partial or complete response (whichever is achieved first) to first date that recurrent of progressive disease is objectively documented, assessed up to 18 months.|Number of patients analyzed are the number of patients who achieved an objective response per Cohort. The response was observed at the last measurement without further follow up due to study closure.|||months||95% Confidence Interval|Median
2588724|NCT02302339|Primary|Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).|The percentage of patients experiencing one or more adverse events.|Up to 18 months following the screening visit||||Participants|||Count of Participants
2588725|NCT02302339|Primary|Objective Response Rate (ORR)|ORR is defined as the percentage of patients who achieved best overall response of complete or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.1), Complete Response (CR) = disappearance of all target lesions and non-target lesions, Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions. ORR was the primary outcome for Cohorts 1-3 and a secondary outcome for Cohort 4.|Every 6 to 9 weeks following treatment initiation until disease progression.|Response evaluable (at least one dose and a post treatment disease assessment)|||Participants|||Count of Participants
2588726|NCT02302222|Primary|Number of Participants With Surgical Site Complications|"Surgical Site Complications:~Dehiscence~Surgical site infection (SSI)"|Within 30 Days Post-Surgical Procedure|Intent to Treat population|||Participants|||Count of Participants
2588727|NCT02302092|Secondary|Number of Participants With Clinically Significant Change in Physical Examination Findings|Physical examination consists of examinations of the following body systems: (1) cardiovascular system; (2) dermatologic system (3) ears, nose, throat; (4) extremities; (5) eyes; (6) gastrointestinal system; (7) genitourinary system; (8) lymph nodes; (9) musculoskeletal system; (10) nervous system; (11) respiratory system.|Day 1 up to Day 21|The safety population included all participants who received any dose of planned study medication.|||participants|||Number
2588728|NCT02302092|Secondary|Number of Participants With Clinically Significant Change in Vital Signs|Vital signs included body temperature (axillary measurement), diastolic and systolic blood pressure (5 minutes), respiratory rate, and pulse (bpm).|Day 1 up to Day 21|The safety population included all participants who received any dose of planned study medication.|||participants|||Number
2590951|NCT02277665|Primary|Treatment Attendance|Attendance operationalized as the number of clinic visits (urine specimens provided)|12 weeks||||visits||Standard Deviation|Mean
2588729|NCT02302092|Secondary|Number of Participants With Clinically Significant Abnormal Laboratory Values|The number of participants with any markedly abnormal (above or below normal ranges) standard safety laboratory values was collected throughout study.|Day 21|The safety population included all participants who received any dose of planned study medication.|||participants|||Number
2588730|NCT02302092|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Treatment-Emergent-Adverse Events (TEAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|Baseline up to Day 30|The safety population included all participants who received any dose of planned study medication.|||participants|||Number
2588731|NCT02302092|Secondary|Percentage of Participants With a Superinfection at the EOT and TOC Visits|A urine sample was collected from the participants at the EOT (Days 7 to 14) and TOC (Days 14 to 21) visits to determine the level of uropathogen. Cultures of the urine sample were processed by using a calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10^4 CFU/mL. A superinfection was defined as growth of a uropathogen other than the original pathogen at a level greater than or equal to 10^4 CFU/mL at any time during the course of active therapy.|Baseline, Day 7 to 14 and 14 to 21|Due to premature trial termination and small sample size, data for superinfection due to particular pathogen numbers in different time periods was not determined.||||||
2588732|NCT02302092|Secondary|Percentage of Participants With a New Infection at the EOT and TOC Visits|A urine sample was collected from the participants at the EOT (Days 7 to 14) and TOC (Days 14 to 21) visits to determine the level of uropathogen. Cultures of the urine sample were processed by using a calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10^4 CFU/mL. A new infection was defined as the isolation and growth of a uropathogen other than the original pathogen.|Baseline, Days 7 to 14 and 14 to 21|Due to premature trial termination and small sample size, data for new infection due to particular pathogen numbers in different time periods was not determined.||||||
2588733|NCT02302092|Secondary|Percentage of Participants With Microbiologic Persistence of the Unique Pathogen at the EOT and TOC Visits|A urine sample was collected from the participants at the EOT (Days 7 to 14) and TOC (Days 14 to 21) visits to determine the level of uropathogen. Cultures of the urine sample was processed by using a calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10^4 CFU/mL. Microbiological response at the TOC visit was be based on the same grades as for the EOT visit. The infection was considered to be persistent if the level of the uropathogen has increased by greater than or equal to 10^4 CFU/mL from the time of study entry to that of the EOT and TOC visits.|Baseline, Days 7 to 14 and 14 to 21|Due to premature trial termination and small sample size, data for persistence of particular pathogen numbers in different time periods was not determined.||||||
2588734|NCT02302092|Secondary|Percentage of Participants With Microbiologic Eradication of the Unique Pathogen at the EOT and TOC Visits|A urine sample was collected from the participants at the EOT (Days 7 to 14) and TOC (Day 14 to 21) visits to determine the level of uropathogen. Cultures of the urine sample were processed by using a calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10^4 CFU/mL. Microbiological response at the TOC visit was based on the same grades as for the EOT visit. The infection was considered to be eradicated if all uropathogens isolated at study entry at a level equal to or greater than 10^4 CFU/mL have decreased to less than 10^4 CFU/mL.|Baseline, Days 7 to 14 and 14 to 21|Due to premature trial termination and small sample size, data for eradication for particular pathogen numbers in different time periods was not determined.||||||
2588735|NCT02302092|Secondary|Percentage of Participants Who Achieved Clinical Resolution of Symptoms of a cUTI at Visit 3, TOC and Late Follow-up (LFU) Visits|At Visit 3 (Day 3) and at the TOC (Days 14 to 21) and LFU visits (Day 30), the Investigator collected information about each symptom and performed a judgement about the participant's status. Clinical symptoms present at trial entry were considered to be resolved if the participant has no pyuria; no fever; no malaise, flank pain, back pain, and/or costo-vertebral angle pain or tenderness; and no symptoms of dysuria, urinary urgency, urinary frequency, suprapubic discomfort, new urinary incontinence, or worsening of pre-existing incontinence. Resolution of all clinical symptoms of cUTI were assessed relative to baseline.|Baseline, Days 3, 14 to 21 and 30|The micro-ITT population included all participants who were randomized and had a baseline bacterial pathogen on culture of urine that causes UTI against which the investigational drug has antibacterial activity.|||percentage of participants|||Number
2588736|NCT02302092|Secondary|Percentage of Participants With Microbiological Success at the EOT and Test-of-Cure (TOC) Visits|A urine sample was collected at EOT (Days 7 to 14) and TOC (Days 14 to 21) visits to determine level of uropathogen. Cultures of urine sample were processed by calibrated loop to identify a quantitative count of bacteria, with a lower limit of 10^4 colony forming units per milliliter (CFU/mL). Microbiological success was defined as bacterial uropathogen level of <10^4 CFU/mL. Microbiological response was categorized as:microbiological eradication/persistence/new infection/superinfection. An infection was eradicated if all uropathogens isolated at study entry at a level ≥10^4 CFU/mL have decreased to <10^4 CFU/mL, persistent if level of uropathogen has increased by ≥10^4 CFU/Ml. A new infection, if there is isolation and growth of a uropathogen other than original pathogen and superinfection if there is growth of a uropathogen other than original pathogen at a level ≥10^4 CFU/mL. Microbiological success was assessed relative to baseline.|Baseline, Days 7 to 14 and 14 to 21|The micro-ITT population included all participants who were randomized and had a baseline bacterial pathogen on culture of urine that causes UTI against which the investigational drug has antibacterial activity.|||percentage of participants|||Number
2588774|NCT02301936|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < the LLOQ 4 weeks following the last dose of study drug.|Posttreatment Week 4|Full Analysis Set|||percentage of participants|||Number
2588737|NCT02302092|Primary|Percentage of Participants Who Achieved Resolution of All Clinical Symptoms of a Complicated Urinary Tract Infection (cUTI) at the End of Treatment (EOT) Visit|At the EOT visit (Days 7 to 14), the Investigator collected information about each symptom and performed a judgement about the participant's status. Clinical symptoms present at trial entry were considered to be resolved if the participant has no pyuria; no fever; no malaise, flank pain, back pain, and/or costo-vertebral angle pain or tenderness; and no symptoms of dysuria, urinary urgency, urinary frequency, suprapubic discomfort, new urinary incontinence, or worsening of pre-existing incontinence. Resolution of all clinical symptoms of cUTI were assessed relative to baseline.|Baseline and Days 7 to 14|The micro-intent to treat (ITT) population included all participants who were randomized and had a baseline bacterial pathogen on culture of urine that causes UTI against which the investigational drug has antibacterial activity.|||percentage of participants|||Number
2588738|NCT02302066|Secondary|Percentage of Participants With Febrile Episodes of Virologically Confirmed Dengue With Onset 30 Days Post-first Vaccination|Participants with febrile illness (defined as temperature ≥ 38°C on 2 consecutive days) were evaluated for dengue. A dengue infection was considered virologically confirmed by either positive polymerase chain reaction (PCR) or NS1 enzyme-linked immunosorbent assay (ELISA). Virologically confirmed dengue with onset 30 days after first vaccination within each group.|From 30 days post-first vaccination through end of study (Day 1460)|Safety Analysis Set included all participants who received at least 1 dose of trial vaccine.|||percentage of participants|||Number
2588739|NCT02302066|Secondary|Percentage of Participants With Serious Adverse Events (SAEs)|An SAE was defined as any untoward medical occurrence or effect that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above-mentioned criteria.|From first vaccination through end of study (Day 1460)|Safety Analysis Set included all participants who received at least 1 dose of trial vaccine.|||percentage of participants|||Number
2588740|NCT02302066|Secondary|Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following Each Vaccination|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.|Within 28 days after each vaccination|Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Safety Set included only participants from Immunogenicity Subset with data available for analyses. Number analyzed is number of participants with data available after each vaccination.|||percentage of participants|||Number
2588741|NCT02302066|Secondary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination|Solicited systemic AEs were collected by participants within 14 days after vaccination and included headache, asthenia, malaise, myalgia and fever. Severity scales for headache were none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents normal activity with or without treatment. Severity scales for others were none, mild: no interference with daily activity, moderate: interference with daily activity and severe: prevents daily activity. A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it.|Within 14 days after each vaccination|Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Only participants in immunogenicity subset were included. Data were summarized separately for each age group. Number analyzed are participants with data available for the category. Only categories for which there was at least 1 participant are reported.|||percentage of participants|||Number
2588742|NCT02302066|Secondary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination|Solicited systemic AEs were collected within 14 days after vaccination using a diary and included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with or without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity and severe: not eating at all. A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination. Fever was excluded from the overall count as no severity grading was applied for it.|Within 14 days after each vaccination|Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Only participants in immunogenicity subset were included. Data were summarized separately for each age group. Number analyzed are participants with data available for the category. Only categories for which there was at least 1 participant are reported.|||percentage of participants|||Number
2588743|NCT02302066|Secondary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following Each Vaccination|Solicited local injection site reactions were collected by participant diary and graded as [Grade 0 (no pain), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents daily activity with or without treatment)]. Erythema and Swelling at injection site were graded as Grade 0 (<25 mm), 1 (mild: ≥25 - ≤ 50 mm), 2 (moderate: > 50 - ≤ 100 mm).|Within 7 days after each vaccination|Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Only participants in immunogenicity subset were included. Data were summarized separately for each age group. Number analyzed are participants with data available for the category. Only categories for which there was at least 1 participant are reported.|||percentage of participants|||Number
2588775|NCT02301936|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set|||percentage of participants|||Number
2588820|NCT02301390|Primary|Number of Participants Who Were Free From All-cause Mortality, Sustained VT or Cardiac Arrest|Number of participants who had no occurrences of all-cause mortality, sustained ventricular tachycardia (VT) and cardiac arrest at 24 months|at 24 months||||Participants|||Count of Participants
2588744|NCT02302066|Secondary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following Each Vaccination|Solicited local injection included pain, erythema at injection site, and swelling at injection site. They were collected using a diary and graded as [Grade 0 (no pain), 1 (mild: minor reaction to touch), 2 (moderate: cries/protests on touch) and 3 (severe: cries when limb is moved/spontaneously painful)]. Erythema and Swelling at injection site were graded as Grade 0 (<10 mm), 1 (mild: ≥10 - ≤ 20 mm), 2 (moderate: > 20 - ≤ 40 mm) and 3 (severe: > 40 mm).|Within 7 days after each vaccination|Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Only participants in immunogenicity subset were included. Data were summarized separately for each age group. Number analyzed are participants with data available for the category. Only categories for which there was at least 1 participant are reported.|||percentage of participants|||Number
2588745|NCT02302066|Secondary|Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset|Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity defined as a reciprocal neutralizing titer ≥10 (for each serotype). The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.|Months 1, 3, 6, 12, 13, 18, 24, 36, and 48|PPS included all participants who received at least 1 dose of trial vaccine, who had a valid pre-dose and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. PPS included only participants from Immunogenicity Subset. Number analyzed are participants with data available at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2588746|NCT02302066|Primary|Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset|GMTs of neutralizing antibodies were measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Data reported for up to Month 48 was collected at Months 1, 3, 6, 12, 13, 18, 24, 36 and 48.|Up to Month 48|Per Protocol Set (PPS): All participants who received at least 1 dose of trial vaccine, who had a valid pre-dose and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. PPS included only participants from Immunogenicity Subset. Number analyzed are participants with data available at the given timepoint.|||titer||95% Confidence Interval|Geometric Mean
2588747|NCT02301988|Secondary|Minimum Observed Plasma Concentration (Cmin) of Ipatasertib|Plasma samples for pharmacokinetic characterization was collected on Day 1 and Day 8 in all participants.|0.5 and 4 hours post dose on Day 1 of Cycle 1, 166 and 170 hours post dose from Day 1 of Cycle 1 (Cycle length = 28 days)|The ITT population included all participants.|||ng/mL||Standard Deviation|Mean
2588748|NCT02301988|Secondary|Plasma Concentrations of Ipatasertib on Day 1 and Day 8|Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants.|0.5 and 4 hours post dose on Day 1 of Cycle 1, 166 and 170 hours post dose from Day 1 of Cycle 1 (Cycle length = 28 days)|The ITT population included all randomized participants. Reported here are data for participants with data available.|||ng/mL||Standard Deviation|Mean
2588749|NCT02301988|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Screening up to Week 24|The safety population was identical to the ITT population and included all randomized participants.|||percentage of participants|||Number
2588750|NCT02301988|Secondary|Percentage of Participants With Response to Conversion to BCS Among Participants With T2 or T3 Tumors|After neoadjuvant treatment, the number of patients who is appropriate for breast conserving surgery is reported as a measure of efficacy of the treatment to shrink the tumor enough for patients to benefit from less aggressive surgical management. Breast-conserving surgery was defined as removal of part of the breast tissue during surgery. T2 or T3 in the AJCC Staging System were defined as follows: T2: tumor was more than 2 centimeter (cm) but no more than 5 cm across; T3: tumor was larger than 5 cm across.|From screening to surgery visit (at approximately Weeks 14 to 19)|The ITT population included all randomized participants with T2 or T3 Tumors with response to conversion to BCS.|||percentage of participants||95% Confidence Interval|Number
2588751|NCT02301988|Secondary|Percentage of Participants With Response to Undergoing Breast Conserving Surgery (BCS) Among Participants With T2 or T3 Tumors|After neoadjuvant treatment, the number of patients who is appropriate for breast conserving surgery is reported as a measure of efficacy of the treatment to shrink the tumor enough for patients to benefit from less aggressive surgical management. Breast-conserving surgery was defined as removal of part of the breast tissue during surgery. T2 or T3 in the AJCC Staging System were defined as follows: T2: tumor was more than 2 centimeter (cm) but no more than 5 cm across; T3: tumor was larger than 5 cm across.|Surgery visit (at approximately Weeks 14 to 19)|The ITT population included all randomized participants with T2 or T3 Tumors.|||percentage of participants||95% Confidence Interval|Number
2588752|NCT02301988|Secondary|Percentage of Participants With pCR According to American Joint Committee on Cancer Staging System, by Breast Cancer Subtype|pCR was defined by ypT0/Tis in the AJCC Staging System with the following determination for breast subtypes by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue. The intrinsic molecular subtypes of breast cancer included here are luminal A (LumA), Her-2, basal-like, normal and unknown.|Surgery visit (at approximately Weeks 14 to 19)|The ITT population included all randomized participants.|||percentage of participants|||Number
2588753|NCT02301988|Secondary|Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in Participants Who Are Akt Dx+)|pCR was defined by ypT0/Tis in the AJCC Staging System with the following determination for breast by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue.|Surgery visit (at approximately Weeks 14 to 19)|The ITT population included all randomized participants who are Akt Dx+.|||percentage of participants||95% Confidence Interval|Number
2588754|NCT02301988|Secondary|Percentage of Participants With pCR in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in Participants Who Are Akt Diagnostic Positive [Dx+])|pCR was defined by ypT0/Tis ypN0 in the AJCC Staging System with the following determination for breast and axilla by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue and N0: no cancer found in the lymph nodes.|Surgery visit (at approximately Weeks 14 to 19)|The ITT population included all randomized participants who are Akt Dx+.|||percentage of participants||95% Confidence Interval|Number
2588755|NCT02301988|Secondary|Percentage of Participants With Objective Tumor Response by MRI, As Assessed by Investigator Per Modified RECIST (in Participants Who Have PTEN-low Tumors)|ORR was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. ORR was the sum of complete response (CR) and partial response (PR). CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|Screening up to disease progression or death (assessed at screening, pre-surgical visit [approximately Weeks 10-12], early termination visit [up to Week 16])|The ITT population included all randomized participants who have PTEN-low tumors.|||percentage of participants||95% Confidence Interval|Number
2588756|NCT02301988|Secondary|Percentage of Participants With Objective Tumor Response by Magnetic Resonance Imaging (MRI), As Assessed by Investigator Per the Modified Response Evaluation Criteria in Solid Tumors (RECIST) (in All Participants)|Objective tumor response (OR) was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of complete response (CR) and partial response (PR). CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|Screening up to disease progression or death (assessed at screening, pre-surgical visit [approximately Weeks 10-12], early termination visit [up to Week 16])|The ITT population included all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2588757|NCT02301988|Secondary|Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in Participants Who Have PTEN-low Tumors)|pCR was defined by ypT0/Tis in the AJCC Staging System with the following determination for breast by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue.|Surgery visit (at approximately Weeks 14 to 19)|The ITT population included all randomized participants who have PTEN-low tumors.|||percentage of participants||95% Confidence Interval|Number
2588758|NCT02301988|Secondary|Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in All Participants)|pCR was defined by ypT0/Tis in the AJCC Staging System with the following determination for breast by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue.|Surgery visit (at approximately Weeks 14 to 19)|The ITT population included all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2588759|NCT02301988|Primary|Percentage of Participants With pCR in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in Participants Who Have Phosphatase and Tensin Homolog [PTEN]-Low Tumors)|pCR was defined by ypT0/Tis ypN0 in the AJCC Staging System with the following determination for breast and axilla by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue and N0: no cancer found in the lymph nodes.|Surgery visit (at approximately Weeks 14 to 19)|The ITT population included all randomized participants who have PTEN-low tumors.|||percentage of participants||95% Confidence Interval|Number
2588760|NCT02301988|Primary|Percentage of Participants With Pathological Complete Response (pCR) in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in All Participants)|pCR was defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer (AJCC) Staging System with the following determination for breast and axilla by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue and N0: no cancer found in the lymph nodes.|Surgery visit (at approximately Weeks 14 to 19)|The ITT population included all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2588761|NCT02301975|Secondary|Change From Baseline in PM PEF|PEF was measured using an electric flow meter each evening. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily PM PEF over the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.|Baseline and Weeks 1-24|ITT Population|||L/min||Standard Error|Least Squares Mean
2588762|NCT02301975|Secondary|Percentage of Participants With Asthma Control Test (ACT) Score Greater Than or Equal to 20|The ACT was a five-item questionnaire developed as a measure of participant's asthma control. The percentage of participants controlled, defined as having ACT score greater than or equal to 20 at the end of Week 24 were analyzed using logistic regression model with covariates of Baseline ACT score, region, sex, age and treatment group.|Week 24|ITT Population|||Percentage of participants|||Number
2588763|NCT02301975|Secondary|Change From Baseline in Morning (Ante Meridiem [AM]) Peak Expiratory Flow (PEF)|PEF was measured using an electric flow meter each morning. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.|Baseline and Weeks 1-24|ITT Population|||Liter per minute (L/min)||Standard Error|Least Squares Mean
2588776|NCT02301936|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants who took at least 1 dose of study drug|||percentage of participants|||Number
2588764|NCT02301975|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour Periods|Change from Baseline in the percentage of symptom-free 24 hour period was evaluated. A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week treatment period minus the Baseline value.Statistical analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.|Baseline and Weeks 1-24|ITT Population|||Percentage of symptom-free 24 hour perio||Standard Error|Least Squares Mean
2588765|NCT02301975|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour Periods|The number of inhalations of rescue medication used during the day and night were recorded by participants using an electronic diary (e-diary). A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week treatment period minus the Baseline value. Statistical analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline, region, sex, age and treatment and least square mean and standard error were calculated.|Baseline and Weeks 1-24|ITT Population|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
2588766|NCT02301975|Primary|Change From Baseline in PM FEV1 Using Per Protocol (PP) Population|FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Statistical analysis was performed using the MMRM models and least square mean and standard error were calculated. The analysis was performed on PP Population which comprised of all participants in the ITT Population who did not had any full protocol deviations.|Baseline and Week 24|PP Population|||L||Standard Error|Least Squares Mean
2588767|NCT02301975|Primary|Change From Baseline in Evening (Post Meridiem [PM]) Forced Expiratory Volume in One Second (FEV1) Using Intent-to-Treat (ITT) Population|FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 (pre-bronchodilator and pre-dose) was measured at Baseline up to Week 24 at evening using spirometry. Repeated Measures analysis was adjusted for Baseline, region, sex, age, treatment, visit, visit by Baseline interaction and visit by treatment interaction. Visit 3 values were taken as Baseline value and change from Baseline was defined as the difference between the value of the endpoint at the time point of interest and the Baseline value. Statistical analysis was performed using the mixed model repeated measures (MMRM) model and least square mean and standard error were calculated. The analysis was performed on ITT Population which comprised of all participants randomized to treatment and who received at least one dose of study medication.|Baseline and Week 24|ITT population|||Liter (L)||Standard Error|Least Squares Mean
2588768|NCT02301936|Secondary|Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)|The FACIT-Fatigue score was measured using a 40-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale from 0 (Not at all) to 4 (Very much). The FACIT-F total score was calculated by taking the sum of all 40 individual scores and ranged from 0-160, with higher scores indicating better quality of life.|Weeks 4,12, 24, Posttreatment Weeks 4 and 12|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2588769|NCT02301936|Secondary|Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower score representing more disability and higher scores representing less disability.|Weeks 4,12, 24, Posttreatment Weeks 4 and 12|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2588770|NCT02301936|Secondary|Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower scores representing more disability and higher scores representing less disability.|Weeks 4,12, 24, Posttreatment Weeks 4 and 12|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2588771|NCT02301936|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,~> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)~Relapse~HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement"|Up to Posttreatment Week 12|Full Analysis Set|||percentage of participants|||Number
2588772|NCT02301936|Secondary|HCV RNA Change From Baseline||Up to 24 weeks|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2588773|NCT02301936|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Weeks 1, 2, 4, 8,12, 16, 20, and 24|Full Analysis Set|||percentage of participants|||Number
2588777|NCT02301897|Secondary|Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug|The total uterine fibroid volume was measured by Magnetic Resonance Imaging (MRI). A negative percentage change from Baseline indicates improvement.|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Off-drug|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage change in fibroid volume||Standard Deviation|Mean
2588778|NCT02301897|Secondary|Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit|"UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 8: During the previous 3 months how distressed were you by feeling fatigued? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage change in UFS-SSS score||Standard Deviation|Mean
2588779|NCT02301897|Secondary|Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit|"UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 7: During the previous 3 months how distressed were you by frequent nighttime urination? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage change in UFS-SSS score||Standard Deviation|Mean
2588780|NCT02301897|Secondary|Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit|"UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 6: During the previous 3 months how distressed were you by frequent urination during the daytime hours? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage change in UFS-SSS score||Standard Deviation|Mean
2588781|NCT02301897|Secondary|Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit|"UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 5: During the previous 3 months how distressed were you by feeling tightness or pressure in your pelvic area? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage change in UFS-SSS score||Standard Deviation|Mean
2588782|NCT02301897|Secondary|Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit|"UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 4: During the previous 3 months how distressed were you by fluctuation in the length of your monthly cycle compared to your previous cycles? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage change in UFS-SSS score||Standard Deviation|Mean
2588783|NCT02301897|Secondary|Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit|"UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 3: During the previous 3 months how distressed were you by fluctuation in the duration of your menstrual period compared to your previous cycle? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage change in UFS-SSS score||Standard Deviation|Mean
2588792|NCT02301793|Secondary|Rates of Pulmonary Embolism (PE) Among Hospitalized Patients|Did the intervention decrease rates of PE among hospitalized patients?|3-12 months after end of study|Data were not collected||||||
2588793|NCT02301793|Secondary|Rates of Deep Vein Thrombosis (DVT) Among Hospitalized Patients|Did the intervention decrease rates of DVT among hospitalized patients?|3-12 months after end of study|Data were not collected||||||
2588784|NCT02301897|Secondary|Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit|"UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 2: During the previous 3 months how distressed were you by passing blood clots during your menstrual period? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage change in UFS-SSS score||Standard Deviation|Mean
2588785|NCT02301897|Secondary|Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit|"UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 1: During the previous 3 months how distressed were you by heavy bleeding during your menstrual period? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement."|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage change in UFS-SSS score||Standard Deviation|Mean
2588786|NCT02301897|Secondary|Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit|UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. Each question was answered on a 5-point scale where 1=Not at all to 5=A very great deal. The sum of total scores was transformed to a range of 0=no symptoms (best) to 100=most severe symptoms (worst). A negative percentage change from Baseline indicates improvement.|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU Visit|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage change in UFS-SSS score||Standard Deviation|Mean
2588787|NCT02301897|Secondary|Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit|Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss. Participants recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Pictorial scores range from score 1 for slightly stained tampon/towel, 5 for a partially stained tampon/towel, 10 for a completely saturated tampon, 20 for a completely saturated towel, and 5 for each episode of flooding and for each blood clot larger than a quarter in size. Total score can range from 0 (no bleeding) to >500. Higher scores indicate more bleeding. Lower scores indicate less bleeding. A negative percentage change from Baseline indicates improvement (reduction in bleeding).|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of ODI Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 28 FU Visit|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage change in PBAC score||Standard Deviation|Mean
2588788|NCT02301897|Secondary|Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit|Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss. Participants recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Pictorial scores range from score 1 for slightly stained tampon/towel, 5 for a partially stained tampon/towel, 10 for a completely saturated tampon, 20 for a completely saturated towel, and 5 for each episode of flooding and for each blood clot larger than a quarter in size. Total score can range from 0 (no bleeding) to >500. Higher scores indicate more bleeding. Lower scores indicate less bleeding. A negative change from Baseline indicates improvement (reduction in bleeding).|Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of ODI Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 28 FU Visit|ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
2588789|NCT02301897|Secondary|Percentage of Participants in Amenorrhea at the End of Treatment Course 2|Amenorrhea was defined as no bleeding intensity score greater than 1 using the Daily Diary Card during the 28 days leading up to the last day of dosing at Week 18. Bleeding intensity was graded on a 5-point scale where: 0=no bleeding to 4=heavy bleeding.|At the end of 18-weeks Treatment Course 2|ITT population consisted of all participants who were randomized and received study drug.|||percentage of participants|||Number
2588790|NCT02301897|Primary|Percentage of Participants in Amenorrhea at the End of Treatment Course 1|Amenorrhea was defined as no bleeding intensity score greater than 1 using the Daily Diary Card during the 28 days leading up to the last day of dosing at Week 18. Bleeding intensity was graded on a 5-point scale where: 0=no bleeding to 4=heavy bleeding.|At the end of 18-weeks Treatment Course 1|Intent-to-treat (ITT) population consisted of all participants who were randomized and received study drug.|||percentage of participants|||Number
2588791|NCT02301793|Secondary|Proportion of Non Administration of Prescribed VTE Prophylaxis Medication Doses Which Are Documented as Patient Refusal|Did the intervention decrease rates of patient refusal of VTE prophylaxis medication doses among hospitalized patients?|Baseline; approximately 3 months later (post education)|The total number of patient visits in each study arm. Overall number of participants represents the number of unique patients in the study. These numbers reflect patient visits at baseline and following the implementation of the nurse education intervention.|||percentage of patient refused doses|patient visits|95% Confidence Interval|Number
2588795|NCT02301793|Primary|Non Administration of Prescribed VTE Prophylaxis Medication Doses|This is the percentage of VTE prophylaxis doses that were not administered for any reason as documented in the electronic health record by a nurse|(Baseline); approximately 3 months later (Post-Education)|The total number of patient visits in each study arm. Overall number of participants represents the number of unique patients in the study. These numbers reflect patient visits at baseline and following the implementation of the nurse education intervention.|||percentage of nonadministration|patient visits|95% Confidence Interval|Number
2588796|NCT02301624|Secondary|Change From Baseline In Myasthenia Gravis Activities Of Daily Living Profile (MG-ADL) Total Score At Week 4 And Week 130|The MG-ADL scale is a validated 8-item patient-reported outcome measure. Participants assessed their functional disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb impairment (2 items). These 8 items were not weighted and were individually graded from 0 (normal) to 3 (most severe), providing a total MG-ADL score ranging from 0 to 24 points. A reduction in score indicates improvement in condition. Baseline was defined as the last available assessment prior to treatment (first study drug infusion) with eculizumab in Study ECU-MG-302. Change from Baseline in MG-ADL total score at Week 4 (blind induction phase) and at Week 130 (open-label eculizumab phase) are presented.|Baseline, Week 4 and Week 130|All participants who received at least 1 dose of eculizumab in this extension study and had an MG-ADL efficacy assessment after study drug infusion at the specified time points.|||units on a scale||Standard Deviation|Mean
2588797|NCT02301624|Primary|Count Of Participants With Treatment-Emergent Adverse Events|Treatment-emergent adverse events (TEAEs) are adverse events with onset on or after the first study drug dose in Study ECU-MG-302. Likewise, treatment-emergent serious adverse events (TESAEs) are serious adverse events that onset on or after the first study drug dose in Study ECU-MG-302. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Day 1 (after dosing) through End of Study (Week 208)|All participants who received at least 1 dose of eculizumab in this extension study.|||Participants|||Count of Participants
2588798|NCT02301429|Primary|All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed.|All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed.|1 month|all subject who underwent a Model 20105 Lead implant attempt are considered in this analysis|||Adverse Events|||Number
2588799|NCT02301416|Secondary|Resting Metabolic Rate|Resting metabolic rate via indirect calorimetry|3 months post-operatively|Outcome measure not obtained||||||
2588800|NCT02301416|Secondary|Resting Metabolic Rate|Resting metabolic rate via indirect calorimetry|6 months post-operatively|Outcome measure not obtained||||||
2588801|NCT02301416|Secondary|Resting Metabolic Rate|Resting metabolic rate via indirect calorimetry|12 months post-operatively|Outcome measure not obtained||||||
2588802|NCT02301416|Secondary|Percent Body Fat|Change in percent body fat|3 months post-operatively|Measure not obtained||||||
2588803|NCT02301416|Secondary|Percent Body Fat|Change in percent body fat|6 months post-operatively|Measure not obtained||||||
2588804|NCT02301416|Secondary|Percent Body Fat|Change in percent body fat|12 months post-operatively|Measure not obtained||||||
2588805|NCT02301416|Secondary|Body Mass Index|Resulting body mass index|3 months post-operatively|2 participants had RYGB instead of Sleeve gastrectomy|||kg/m^2||95% Confidence Interval|Mean
2588806|NCT02301416|Secondary|Body Mass Index|Resulting body mass index|6 months post-operatively|2 participants had RYGB instead of Sleeve gastrectomy|||kg/m^2||95% Confidence Interval|Mean
2588807|NCT02301416|Secondary|Body Mass Index|Resulting body mass index|12 months post-operatively|2 participants had RYGB instead of Sleeve gastrectomy|||kg/m^2||95% Confidence Interval|Mean
2588808|NCT02301416|Secondary|Percent Weight Change|Percent weight loss achieved before and after surgery while taking the medication, Qsymia.|Pre-operatively and 3 months post-operatively|2 participants had RYGB instead of sleeve gastrectomy|||Percent||95% Confidence Interval|Mean
2588809|NCT02301416|Secondary|Percent Weight Change|Percent weight loss achieved before and after surgery while taking the medication, Qsymia.|Pre-operatively and 6 months post-operatively|2 participants had RYGB instead of sleeve gastrectomy|||Percent||95% Confidence Interval|Mean
2588810|NCT02301416|Secondary|Percent Weight Change|Percent weight loss achieved before and after surgery while taking the medication, Qsymia.|Pre-operatively and 12 months post-operatively|2 participants had RYGB instead of sleeve gastrectomy|||Percent||95% Confidence Interval|Mean
2588811|NCT02301416|Secondary|Resting Metabolic Rate|Resting metabolic rate via indirect calorimetry|24 months post-operatively|Outcome measure not obtained||||||
2588812|NCT02301416|Secondary|Percent Body Fat|Change in percent body fat|24 months post-operatively|Measure not obtained||||||
2588813|NCT02301416|Secondary|Body Mass Index|Resulting body mass index|24 months post-operatively|2 participants had RYGB instead of Sleeve gastrectomy|||kg/m^2||95% Confidence Interval|Mean
2588814|NCT02301416|Secondary|Percent Weight Change|Percent weight loss achieved before and after surgery while taking the medication, Qsymia.|Pre-operatively and 24 months post-operatively|2 participants had RYGB instead of sleeve gastrectomy|||Percentage of weight change||95% Confidence Interval|Mean
2588815|NCT02301416|Primary|Proportion of Patients Who do Not Meet the Criteria to Move Forward With Roux en Y Gastric Bypass (RYGB)|Proportion of patients who do not meet the criteria to move forward with a second surgical procedure following an initial procedure plus the medication Qsymia. The criteria that suggest RYGB is indicated are: 1) BMI of 40 or greater or 2) BMI of 35-39.9 with poorly controlled co-morbidities.|24 months post-operatively|2 participants had RYGB instead of Sleeve Gastrectomy|||Participants|||Count of Participants
2588816|NCT02301403|Primary|Number of Participants With Abstinence From Smoking|The outcome measure consists of the number of participants reporting abstinence from smoking at 6 months that is biochemically confirmed (exhaled carbon monoxide < 6 parts per million).|6 months post treatment|Adult smokers interested in quitting smoking who met inclusion and exclusion criteria.|||Participants|||Count of Participants
2588817|NCT02301390|Secondary|Change in LV Ejection Fraction|Change in left ventricle (LV) ejection fraction between paired measurements recorded at 24 months as compared to baseline|baseline and 24 months|Data for only those who had two time points LV ejection fraction data|||percent||Standard Deviation|Mean
2588823|NCT02301377|Primary|Medication Adherence|Overall adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins based on prescription refill data. The actual number of prescriptions of each of the three medications filled in the 3-month period was divided by the number that should have been filled based on the prescribed amount of each medication and that value was multiplied by a 100 to generate a percentage.|3 months||||Percent Adherence||Standard Deviation|Mean
2588824|NCT02301364|Secondary|Overall Response Rate|This study will use the Macdonald criteria. Specific lesions must be evaluated serially, and comparative analysis of changes in the area of contrast enhancement, as well as the non-enhancing component, should be performed. Complete Response: Complete disappearance of all measurable and non-measurable disease. No new lesions. Partial Response: Great than or equal to 50% decrease over the baseline in the sum of products of perpendicular diameters of all measurable lesions. no progression of non-measurable disease. No new lesions. Stable/No Response: Does not qualify for CT, PR, or progression. Progressive Disease: 25% increase in the sum of products of all measureable lesions over smallest sum observes (or baseline if no decrease), OR clear clinical worsening of any non-measurable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).|2 years||||Participants|||Count of Participants
2588825|NCT02301364|Secondary|Overall Survival|Overall survival time is defined as the time from treatment start to the date of death due to any cause.|2 years||||days||Full Range|Median
2588826|NCT02301364|Secondary|Number of Participants With Adverse Events|Adverse events be summarized based on the Common Toxicity Criteria version 4.0.|2 years||||Participants|||Count of Participants
2588827|NCT02301364|Primary|Progression Free Survival|Progression-free survival (PFS) is defined as the time from the date of treatment start to the date of the first documented PD or death due to any cause. PFS will be based on the investigator's assessment of MRI, CSF studies and clinical presentation.|2 years||||days||Full Range|Median
2588828|NCT02301299|Secondary|Change in Knowledge and Self-efficacy|"Specified outcomes were 1) knowledge and attitudes and 2) self-efficacy. The standardized test for assessing knowledge and behavioral intent will be the Stroke Action Test, a validated assessment tool to assess emergency responses to various stroke and non-stroke scenarios. STAT has excellent reliability and takes, on average, 5 minutes to complete. Scores range from 0-100% and are the average correct responses for each of 28 items in the STAT questionnaire. For self-efficacy, we will use the Likert scale ranging from 1 (strongly agree) to 4 (strongly disagree) on the following questions based on a previous study: 1. I would not be able to tell if someone is having a stroke; and 2. If I saw someone having a stroke, I would not know what to do. Scores range from 2-8 units on the scale. For STAT, higher values indicate better outcome while for self-efficacy, lower values indicate better outcome."|12 months|We sampled residents from the target neighborhoods and comparison neighborhoods before and after the intervention using a standardized set of questions assessing knowledge, self-efficacy, and trust.|||score on a scale||Standard Deviation|Mean
2588829|NCT02301299|Primary|Emergency Medical Services (EMS) Utilization for Stroke|Emergency medical services (EMS) utilization (%) was defined as the proportion of stroke patients arriving to the emergency department by EMS, as opposed to private transport/taxi/other from home/scene. Admissions with Chicago Fire Department (CFD) record confirmed EMS arrival were considered as EMS arrival. All others were considered as non-EMS arrival. The effect size is measures a change in slope: percent of participants per month.|5 years; January 2013 to December 2017|Trinity hospital is located on the south side of Chicago, within the intervention areas. Age range of patients was 19 to 103; approximately a half of the patients were 66 years or older and female. A majority of the patients were non-Hispanic Blacks.|||change in percent EMS arrival/month|||Number
2588830|NCT02301299|Primary|Early Arrival After Stroke Onset|Early hospital arrival was defined as the proportion of stroke patients arriving within three hours from symptom onset to intervention hospital. When symptom onset time was unknown or missing, last well-known time was used as symptom onset time. When both symptom onset time and last well-known time were unknown or missing, that admission was treated as late arrival.|5 years; January 2013 to December 2017|The intervention hospital is located on the south side of Chicago, within the target community intervention area. Age range of patients was 19 to 103; a majority of the patients were African-Americans, approximately half were 66 years or older and female.|||change in percent early arrival/month|||Number
2588831|NCT02301169|Secondary|Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Brief Pain Inventory (BPI).|"Arithmetic average of 3 questions on an 11-point Numeric Rating Scale (NRS) from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine.~Lower values represent a better outcome"|Time zero equals baseline (Day 1) up to Day 28||||units on a scale||Standard Deviation|Mean
2588832|NCT02301169|Secondary|Patient's Change of Pain Intensity After Heat Pain Stimuli From Baseline to End of Treatment Period|11-point Numeric Rating Scale (NRS) from 0 to 10; 0 meaning no pain, 10 pain as bad as you can imagine Lower values represent a better outcome Unit: arithmetic average on 6 reported scores per Visit.|Time zero equals baseline (Day 1) up to Day 28||||units on a scale||Standard Deviation|Mean
2588833|NCT02301169|Secondary|Patient's Change From Baseline of Investigator Global Assessment of Change (IGAC)|IGAC is an investigator subjective evaluation of patient condition using a NRS from 0 to 10 with 0 meaning best and 10 worst Lower values represent a better outcome.|Time zero equals baseline (Day 1) up to Day 28||||units on a scale||Standard Deviation|Mean
2588834|NCT02301169|Secondary|Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Worst Pain Scores (WPS)|11-point Numeric Rating Scale (NRS) Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS|Time zero equals baseline (Day 1) up to Day 42||||units on a scale||Standard Deviation|Mean
2588835|NCT02301169|Primary|Patient 's Change From Baseline of Pain Severity as Measured by the Weekly Means of the Daily Average Pain Scores (APS) During 4 Weeks of Treatment|11-point Numeric Rating Scale (NRS). Scale from 0 to 10, 0 meaning no pain, 10 pain as bad as you can imagine. Lower values represent a better outcome. Unit: arithmetic average of 7 days of a 11-point NRS|Time zero equals baseline (Day 1) up to Day 42||||units on a scale||Standard Deviation|Mean
2589237|NCT02295020|Primary|KOOS - Pain|Value at 8 weeks - value at day 0|Week 8- Day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.|||units on a scale||95% Confidence Interval|Least Squares Mean
2588836|NCT02301143|Secondary|Participants With Treatment Emergent Adverse Events (TEAEs)|"TEAEs are defined as any adverse event (AE) that begin or worsen on or after the start of study drug or procedure of the study period through the maximum duration of the period plus 28 days. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death. Relation to study drug was determined by the investigator. A treatment-related TEAE is defined as TEAE which was considered to be related to one or both of the study drugs and reported as 'Suspected' on the case report form. AEs with a missing relationship were treated as 'treatment-related' in data summaries. IP (investigational product) refers to nab-Paclitaxel and/or Gemcitabine. Related TEAE refers to relation to study drug (IP)."|Day 1 of study drug up to end of the study; up to 31.3 months|The Treated population consists of all participants who received at least 1 dose of nab-paclitaxel or gemcitabine.|||Participants|||Count of Participants
2588837|NCT02301143|Secondary|Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): 10 Individual Item Scores|The EORTC pancreatic cancer module is a validated tool intended for patients at all disease stages undergoing surgical resection, palliative surgical intervention, endoscopic palliation or palliative chemotherapy. The module includes 26 questions, organized into 7 scales and 10 individual item scores. The 10 individual item scores are reported. All reported measures are transformed to a 0 to 100 scale. Scores of 0 = best possible health state and 100 = worst possible health state. The best score on treatment is the best score from all post-baseline visits and is compared to the baseline to get the following responder categories. Responder categories: - Improved: >=MID decrease from baseline - Stable: no increase or decrease >MID - Worsened: >=MID increase from baseline MID = half the baseline standard deviation|Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit|Intent to treat population was defined as all participants enrolled into the study with both baseline and post baseline values.|||Participants|||Count of Participants
2588838|NCT02301143|Secondary|Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): Satisfaction With Health Care Scale|The EORTC pancreatic cancer module is a validated tool intended for patients at all disease stages undergoing surgical resection, palliative surgical intervention, endoscopic palliation or palliative chemotherapy. The module includes 26 questions, organized into 7 scales and 10 individual item scores. The summary scale for Satisfaction with Health Care is reported. All reported measures are transformed to a 0 to 100 scale. Scores of 0 = not satisfied, worst possible health state and 100 = extremely satisfied, best possible health state. The best score on treatment is the best score from all post-baseline visits and is compared to the baseline to get the following responder categories. Responder categories: - Improved: >=MID increase from baseline - Stable: no increase or decrease >MID - Worsened: >=MID decrease from baseline MID = half the baseline standard deviation|Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit|Intent to treat population was defined as all participants enrolled into the study with both baseline and post baseline values.|||Participants|||Count of Participants
2588839|NCT02301143|Secondary|Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire For Pancreatic Cancer (EORTC-QLQ PAN26): Six Summary Scales|The EORTC pancreatic cancer module is a validated tool intended for patients at all disease stages undergoing surgical resection, palliative surgical intervention, endoscopic palliation or palliative chemotherapy. The module includes 26 questions, organized into 7 scales and 10 individual item scores. All reported measures are transformed to a 0 to 100 scale. Six summary scales reported are: - Pancreatic Pain - Digestive Symptoms - Altered Bowel Habits - Hepatic Scale - Body Image - Sexuality Scores of 0 = optimal health state and 100 = worst possible health state. The best score on treatment is the best score from all post-baseline visits and is compared to the baseline. Responder categories: - Improved: >=MID decrease from baseline - Stable: no increase or decrease >MID - Worsened: >=MID increase from baseline MID = half the baseline standard deviation|Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit|Intent to treat population was defined as all participants enrolled into the study with both baseline and post baseline values.|||Participants|||Count of Participants
2588840|NCT02301143|Secondary|Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Symptom Scales and Single Symptom Items|The European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30) is a validated health-related quality of life (HRQoL) measure. The EORTC QLQ-C30 is composed of both multi-item scales and single-item measures, including 5 functional scales, 3 symptom scales, 6 single symptom items, and 1 global health status / quality of life scale. No item occurs in more than one scale. All reported measures are transformed to a 0 to 100 scale. In the symptom scales and single symptom items, 0 = optimal health state and 100 = worst possible health state. The best score on treatment is the best score from all post-baseline visits and is compared to the baseline to get the following responder categories. Responder categories: - Improved: >=10 decrease from baseline - Stable: neither increase nor decrease >10 - Worsened: >=10 increase from baseline|Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit|Intent to treat population was defined as all participants enrolled into the study with both baseline and post baseline values.|||Participants|||Count of Participants
2588848|NCT02300727|Secondary|Change in Subjective Patient Self- Assessment of Oral Mucositis Measured by the Common Terminology Criteria for Adverse Events (CTCAE) and World Health Organization's (WHO's) Oral Toxicity Scale (OTS)|NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze|Baseline, weekly for 5 to 7 weeks|||||||
2588849|NCT02300727|Secondary|Change in Subjective Patient Self-assessment of Pain.|NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze|Baseline, weekly for 5 to 7 weeks|||||||
2588850|NCT02300727|Secondary|Change in Toxicities Graded by Health Care Providers Using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Zero participants analyzed.|Baseline, weekly for 5 to 7 weeks|||||||
2588841|NCT02301143|Secondary|Participant Counts in Response Categories Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): Global Health Status and 5 Functioning Scales|The European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC QLQ-C30) is a validated health-related quality of life (HRQoL) measure. The EORTC QLQ-C30 is composed of both multi-item scales and single-item measures, including 5 functional scales, 3 symptom scales, 6 single symptom items, and 1 global health status / quality of life scale. No item occurs in more than one scale. All reported measures are transformed to a 0 - 100 scale. In the Global Health Status and 5 functional scales, 0 = worst possible quality of life/health status and 100 = best possible quality of life/health status. The best score on treatment is the best score from all post-baseline visits and is compared to the baseline to get the following responder categories. Responder categories: - Improved: >=10 increase from baseline - Stable: neither increase nor decrease >10 - Worsened: >=10 decrease from baseline|Baseline (Day -1), Day 1 of each cycle, for up to 19 cycles each cycle consisting of 28 days and the 28-day follow-up visit|Intent to treat population was defined as all participants enrolled into the study with both baseline and post baseline values.|||Participants|||Count of Participants
2588842|NCT02301143|Secondary|Kaplan-Meier Estimates for Overall Survival (OS)|Overall survival was defined as the time from the date of first dose of study therapy to the date of death (by any cause). Participants who were alive at the end of study or clinical data cut were censored on the last known time that the participant was alive or the clinical cutoff date, whichever was earlier. Median and its 90% confidence interval of OS were estimated using the method of Brookmeyer and Crowley|Day 1 of study treatment up to 31.34 months (maximum time for survival follow-up)|Intent to treat population was defined as all participants who were enrolled into the study.|||months||90% Confidence Interval|Median
2588843|NCT02301143|Secondary|Kaplan-Meier Estimate of Progression-Free Survival (PFS)|"Progression-free Survival (PFS) was defined as the time from the date of the first dose to the date of disease progression or death (by any cause), whichever is earlier. The analysis day was calculated from enrollment date for one participant who was not treated. Participants who have no disease progression or have not died were censored to last tumor assessment date with progression-free.~The definition for progressive disease (PD) was at least a 20% increase in the sum of diameters of target lesions from nadir; the sum must also demonstrate an absolute increase of >= 5 mm; the progression of a non-target lesion or the appearance of any new lesions is also considered progression.~Median and its 90% confidence interval of PFS were estimated using the method of Brookmeyer and Crowley."|Day 1 of study treatment up to 28.75 months (maximum time for the last tumor assessment)|Intent to treat population was defined as all participants who were enrolled into the study.|||months||90% Confidence Interval|Median
2588844|NCT02301143|Secondary|Overall Response Rate (ORR): Percentage of Participants With Complete (CR) or Partial Response (PR) According to RECIST Version 1.1|"ORR was defined as the percentage of participants that achieved a combined incidence of complete (CR) and partial response (PR) using RECIST 1.1 guidelines as assessed by the investigator. Assessments after new non-protocol-defined anticancer therapy are excluded. For participants who had resectable surgery in Investigator Choice period, assessments after surgical intervention are excluded.~RECIST 1.1 Definition:~CR: disappearance of all target and non-target lesions; any pathological lymph nodes (target or non-target) must have reduction in short axis to < 10 mm and no new lesions diagnosed.~PR: a >= 30% decrease in the sum of diameters of target lesions from baseline; no evidence of progression in any of the non-target lesions diagnosed at baseline; and no new lesions diagnosed.~The two-sided 90% binomial confidence intervals (CIs) were estimated by Wilson score method"|Day 1 of study treatment up to the end of investigator choice period plus 28 days; up to 76.9 weeks|Intent to treat population was defined as all participants who were enrolled into the study.|||percentage of participants||90% Confidence Interval|Number
2588845|NCT02301143|Secondary|Disease Control Rate (DCR): Percentage of Participants With Complete (CR) or Partial Response (PR), or Stable Disease (SD) for ≥ 16 Weeks According to RECIST Version 1.1|"DCR was defined as the percentage of participants with a CR or PR or SD from of date of first treatment to 16 weeks. Tumor assessments after start of non-protocol-defined anticancer therapy were excluded.~RECIST 1.1 Definition:~CR: disappearance of all target and non-target lesions; any pathological lymph nodes (target or non-target) must have reduction in short axis to < 10 mm and no new lesions diagnosed.~PR: a >= 30% decrease in the sum of diameters of target lesions from baseline; no evidence of progression in any of the non-target lesions diagnosed at baseline; and no new lesions diagnosed.~SD: neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for PD.~The two-sided 90% binomial confidence intervals (CIs) were estimated by Wilson score method."|Day 1 of study treatment up to the end of investigator choice period plus 28 days; up to 76.9 weeks|Intent to treat population was defined as all participants enrolled into the study.|||percentage of participants||90% Confidence Interval|Number
2588846|NCT02301143|Primary|Kaplan-Meier Estimates for Time to Treatment Failure (TTF)|"TTF was defined as the time after the first dose of study therapy to discontinuation of study therapy due to disease progression, death by any cause, or the start of a new non-protocol-defined anticancer therapy/surgery. If a participant does not progress, die or start a new non-protocol-defined anticancer therapy, the participant was censored on the last tumor assessment date.~Tumor evaluations of CT or MRI scans were assessed by the investigative sites and response determined according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1.~The definition for progressive disease (PD) was >= 20% increase in the sum of diameters of target lesions from nadir, and the sum showed an absolute increase of >= 5 mm; the progression of a non-target lesion or the appearance of any new lesions is also considered progression.~Median and its 90% confidence interval (CI) of TTF were estimated using the method of Brookmeyer and Crowley."|Day 1 of study treatment up to 28.75 months; (maximum time for the last tumor assessment)|Intent to treat population was defined as all participants enrolled into the study.|||months||90% Confidence Interval|Median
2588847|NCT02300727|Secondary|Change in Health Providers Assessment of Oral Mucositis and Healing Time Measured by the Common Terminology Criteria for Adverse Events (CTCAE) and World Health Organization's (WHO's) Oral Toxicity Scale (OTS)|NA - Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze|Baseline, then weekly for 4 to 6 weeks|||||||
2588891|NCT02299934|Secondary|The Percentage of Examinations That Caused Adverse Events||Day 1|Study was terminated prior to collecting any outcome measure data.||||||
2588851|NCT02300727|Primary|Number of Participants With Serious and Non-Serious Adverse Events|Number of Participants with Serious and Non-Serious Adverse Events.|reviewed weekly for 4 to 6 weeks|Protocol ended early after failing to enroll sufficiently. Only 6 subjects enrolled, 5 completed, 1 withdrew. Insufficient data to analyze.|||Participants|||Count of Participants
2588852|NCT02300610|Secondary|Overall Survival (OS)|Dose Expansion. Overall survival is defined as the time from randomization until death from any cause, and is measured in the intent-to-treat population.|Up to 24 Months||||months||95% Confidence Interval|Median
2588853|NCT02300610|Secondary|Progression Free Survival (PFS)|Dose Expansion. PFS is defined as the time from randomization until objective tumor progression or death. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).|14 months|All Participants.|||months||95% Confidence Interval|Median
2588854|NCT02300610|Secondary|Overall Response Rate (ORR): Complete Response (CR) + Partial Response (PR)|Dose Expansion. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|Up to 6 months|All participants evaluable at time of analysis.|||Participants|||Count of Participants
2588855|NCT02300610|Primary|Recommended Dose of Enzalutamide|"Dose Escalation. Maximum Tolerated Dose (MTD) of Enzalutamide when given with Cisplatin and Gemcitabine at standard doses. Dose Level 1: 80 mg Enzalutamide; Dose Level 2: 160 mg Enzalutamide.~Dose-Limiting Toxicity (DLT) is defined as any of the following occurring in the first 21 days (cycle 1) of study participation that are considered at least possibly related to enzalutamide administration. Toxicities that are in the opinion of the investigator(s) attributable exclusively to gemcitabine or cisplatin will not be considered DLT.~7 consecutive missed doses (out of 21 doses) of enzalutamide in 21 days due to study drug related toxicity.~Missed day 8 dose of gemcitabine in cycle 1 will not be considered DLT.~Delay of greater than 3 weeks from scheduled date in initiating cycle 2 due to study drug related toxicity.~Discontinuation of a patient due to study drug related toxicity before completing cycle 1."|Up to 6 months|All participants in Dose Escalation arm.|||mg|||Number
2588856|NCT02300558|Secondary|Change From Baseline in Mean Nocturnal QTcF Interval to Week 24 (Lead V5; Holter)|"Baseline was the Day 1 value.~QTcF is corrected QT interval using Fridericia's formula. QTcF = QT/cube root (RR), where RR is in seconds.~Mean nocturnal QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from the first nonmissing nominal time point to the last nonmissing nominal time point, from midnight to 6:00 AM."|Baseline; Week 24|Participants in the the Full Analysis Set with available data were analyzed.|||msec||95% Confidence Interval|Mean
2588857|NCT02300558|Secondary|Change From Baseline in Mean Daily (Daytime and Nocturnal) QTcF Interval to Week 24 (Lead V5; Holter)|"Baseline was the Day 1 value.~QTcF is corrected QT interval using Fridericia's formula. QTcF = QT/cube root (RR), where RR is in seconds.~Mean daytime QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from the first nonmissing nominal time point to the last nonmissing nominal time point, from predose to 6 hours postdose. Mean nocturnal QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from the first nonmissing nominal time point to the last nonmissing nominal time point, from midnight to 6:00 AM. Daily was computed as the average of daytime (AUC0-6/6) and nocturnal (AUC0-6/6), with both values required to compute the average."|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.|||msec||95% Confidence Interval|Mean
2588858|NCT02300558|Secondary|Change From Baseline in Mean Daytime QTcF Interval (AUC0-6/6) to Week 12 (Lead V5; Standard 12-lead ECG)|"Baseline was the Day 1 value.~QTcF is corrected QT interval using Fridericia's formula. QTcF = QT/cube root (RR), where RR is in seconds.~AUC0-6 for QTcF was calculated using the trapezoidal rule, mean of triplicate values, and actual time (latest of triplicate times) .~Mean daytime QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from dosing to the 6 hour postdose time point."|Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.|||msec||95% Confidence Interval|Mean
2588859|NCT02300558|Primary|Change From Baseline in Mean Daytime QT Interval in Lead V5 Corrected for Heart Rate Using the Fridericia Formula (QTcF) Interval to Week 24 (Based on Standard 12-lead ECG Data)|"Baseline was the Day 1 value.~QTcF is corrected QT interval using Fridericia's formula. QTcF = QT/cube root (RR), where RR is in seconds.~AUC0-6 for QTcF was calculated using the trapezoidal rule, mean of triplicate values, and actual time (latest of triplicate times).~Mean daytime QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from dosing to the 6 hour postdose time point."|Baseline; Week 24|Participants in Full Analysis Set (FAS) with available data were analyzed. FAS was defined as all enrolled participants who have confirmed LQT3 genotype, do not have confirmed LQT1 or LQT2 mutations, received at least 1 dose of active eleclazine, and have both a baseline and at least 1 postbaseline mean daytime QTcF interval (standard 12-lead).|||msec||Standard Deviation|Mean
2588860|NCT02300311|Secondary|Patient's Assessment of the Efficacy on the Last Individual Treatment Day|Patients were asked to rate the effect of the study medication for relieving their low back pain using a 4-point verbal rating scale (1=Poor, 2= Fair, 3=Good, 4=Very Good).|1 to 4 days|Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.|||percentage of participants|||Number
2588861|NCT02300311|Secondary|Difference of Average Pain Intensity (APID) From Pre-dose Baseline on the Last Individual Treatment Day|"Difference of average pain intensity from pre-dose baseline on the last individual treatment day (The last individual treatment day was the last day on which the patient had recorded the study drug applications within the patient diary). Pain intensity was assessed by the patient using 0-10 numerical rating scale (NRS).~Patients were given two 0-10 numerical rating scales (NRS) - to self-report of pain intensity at given time points for the period 0-8 hours post first dose and to self-report of average pain intensity they had at each treatment day. The left side of each scale (0) is marked 'no pain' and the right side of the scale (10) is marked 'worst pain possible'. APIDtime point = APItime point - PI baseline (time point is the last individual treatment day (either Day 1, 2, 3 or 4 after drug administration)).~Means reported are the adjusted means."|Baseline and 1 to 4 days|Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.|||points on a scale||Standard Error|Mean
2588862|NCT02300311|Secondary|Pain Intensity Difference (PID) From Pre-dose Baseline to 4 Hours After the First Trial Medication Application (PID4h)|Pain intensity was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3 and 4 hours after trial medication application. The left side of each scale (0) is marked 'no pain' and the right side of the scale (10) is marked 'worst pain possible'. PID4h= PI(4h) - PI(baseline). Means reported are the adjusted means.|Baseline and 4 hours after trial medication application|Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.|||points on a scale||Standard Error|Mean
2588863|NCT02300311|Primary|Pain Intensity Difference (PID) From Pre-dose Baseline to 8h After the First Trial Medication Application (PID8h)|"Pain intensity (PI) was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3, 4, 6 and 8 hours after trial medication application.~The left side of each scale (0) is marked 'no pain' and the right side of the scale (10) is marked 'worst pain possible'.~PID8h= Pain intensity (PI)8h - PI(baseline).~Means reported are the adjusted means."|Baseline and 8 hours after trial medication application|Full analysis set (FAS): All patients included in the treated set who provide any post-treatment data for the primary efficacy endpoint constituted the full analysis set.|||points on a scale||Standard Error|Mean
2588864|NCT02300298|Secondary|AUC0-infinity of Docetaxel|This outcome measure presents the AUC0-infinity of docetaxel in plasma in cycles 1 and 2.|just before administration of docetaxel administration -0:05 hours (h), at the end of infusion (1:00), and at timepoints after the first dose of docetaxel 1:30 h, 2, 3, 4, 7, 23:55, 47:55 h in cycle 1 and 2 (if administered)|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2588865|NCT02300298|Secondary|Area Under the Concentration-time Curve of Nintedanib Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)|This outcome measure presents the Area under the concentration-time curve of nintedanib over the time interval from 0 extrapolated to infinity in plasma (AUC0-infinity) in cycle 1.|at 23:55 hours (h) after the first dose of docetaxel (which is 5 minutes prior to first dose of nintedanib) and at 25, 26, 27, 28, 30, 31, 34 and 47:55 h after first drug administration of docetaxel in cycle 1.|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2588866|NCT02300298|Secondary|AUC0-tz of Docetaxel|This outcome measure presents AUC0-tz of docetaxel in plasma in cycles 1 and 2.|just before administration of docetaxel administration -0:05 hours (h), at the end of infusion (1:00), and at timepoints after the first dose of docetaxel 1:30 h, 2, 3, 4, 7, 23:55, 47:55 h in cycle 1 and 2 (if administered)|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2588867|NCT02300298|Secondary|Area Under the Concentration-time Curve of Nintedanib Over the Time Interval From 0 to Time of the Last Quantifiable Concentration (AUC0-tz)|This outcome measure presents the area under the concentration-time curve of nintedanib over the time interval from 0 to time of the last quantifiable concentration in plasma (AUC0-tz) in cycle 1.|At 23:55 hours (h) after the first dose of docetaxel (which is 5 minutes prior to first dose of nintedanib) and at 25, 26, 27, 28, 30, 31, 34 and 47:55 after first drug administration of docetaxel in cycle 1.|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2588868|NCT02300298|Secondary|Cmax of Docetaxel|This outcome measure presents the Cmax of docetaxel in plasma in cycles 1 and 2.|just before administration of docetaxel administration -0:05 hours (h), at the end of infusion (1:00), and at timepoints after the first dose of docetaxel 1:30 h, 2, 3, 4, 7, 23:55, 47:55 h in cycle 1 and 2 (if administered)|PKS|||nanogram (ng)/ millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
2588869|NCT02300298|Secondary|Maximum Measured Concentration (Cmax) of Nintedanib|This outcome measure presents the maximum measured concentration (Cmax) of nintedanib in plasma in cycle 1.|At 23:55 hours (h) after the first dose of docetaxel (which is 5 minutes prior to first dose of nintedanib) and at 25, 26, 27, 28, 30, 31, 34 and 47:55 h after first drug administration of docetaxel in cycle 1.|Pharmacokinetic set (PKS) included all patients in treated set who had at least one valid drug plasma concentration available. This patient set was used for the analysis of pharmacokinetics.|||nanogram (ng)/ millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
2588870|NCT02300298|Primary|Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1|"DLT was defined as any of the following study drug related adverse events (AEs):~Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 non-haematological toxicity except transient electrolyte abnormality and isolated increase of gamma-glutamyltransferase (GGT); gastrointestinal toxicity, despite adequate supportive care~CTCAE grade 4 haematological toxicity; Neutrophil count decreased or white blood cell count (not associated with fever) for >7 days despite adequate supportive treatment~CTCAE grade 4 febrile neutropenia with fever ≥38.5 degrees~CTCAE grade ≥2 alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) increase in conjunction with CTCAE grade ≥2 total bilirubin increase~Inability to resume nintedanib dosing within 14 days after stopping Investigators judged clinically as DLT after dose reduction and severity medically notable (CTCAE, version 3). Sponsor with safety review committee was allowed to confirm the adequacy of this judgment."|Cycle 1, from first administration of study medication up to 21 days thereafter.|Treated set 2 included all patients who were dispensed study medication and were documented to have taken at least one dose of study treatment, except replaced patients according to the trial clinical protocol.|||Participants|||Number
2588871|NCT02300129|Primary|Total Number of Flushes for Each 2-week Period||Day 22 and Day 36/Early termination|Per protocol population of Period 2, N= 31|||Flushes count||Standard Deviation|Mean
2588872|NCT02300103|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2588873|NCT02300103|Secondary|HCV RNA Change From Baseline||Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2588874|NCT02300103|Secondary|Percentage of Participants With HCV RNA < LLOQ On-treatment||Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2588875|NCT02300103|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2588876|NCT02300103|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set|||percentage of participants|||Number
2588877|NCT02300103|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: all enrolled participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2588878|NCT02300077|Secondary|Pain Relief Within First 30 Postoperative Days|"Daily pain self-assessments using a numeric (0-10) rating scale were recorded in a home diary for approx 30 days following surgery (from hospital discharge until postop clinic visit). Zero was no pain and 10 was the worst possible pain.~Patient`s 30-day post-discharge scores were averaged individually and compared in between groups.~In addition, participants recorded pain interference with 7 activities of daily living - mood, ability to walk or move, sleep, normal work outside the home, normal work at home, recreational activities, and enjoyment of life on a 5-point Likert scale. Questions were based on the Patient-Reported Outcomes Measurement Information System Pain Behavior and Pain Interference item banks. Patients also recorded opioid and nonopioid analgesic use, sedation, and time to return to work."|30 days||||score on a scale||Inter-Quartile Range|Median
2588879|NCT02300077|Secondary|Opioid Consumption Within First 30 Postoperative Days|Daily opioid consumption for approx 30 days following surgery (from hospital discharge until postop clinic visit).|30 days||||total postdischarge opioid pills used||Inter-Quartile Range|Median
2588880|NCT02300077|Primary|Postoperative Opioid Administration|Data on opioids administered postoperatively will be collected from the subject's EMR. Pain severity will be assessed using Numeric Rating Scale and colored-visual analogue scale. Pain relief postoperatively will be assessed using a 5 point scale [0-no relief, 4-complete relief]|EMR reviewed at 24 hours post-administration or at hospital discharge||||morphine equivalents mg||Inter-Quartile Range|Median
2588881|NCT02300077|Primary|Intraoperative Opioid Administration|Data on opioids administered intraoperatively will be collected from the subject's EMR.|Administered at induction of anesthesia||||morphine equivalents mg||Inter-Quartile Range|Median
2588882|NCT02300025|Primary|Apparent Volume of Distribution (Vz/F)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F after the oral dose is influenced by the fraction absorbed.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||Liter||Standard Deviation|Mean
2588883|NCT02300025|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||Liter per hr (L/hr)||Standard Deviation|Mean
2588884|NCT02300025|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration of cobimetinib to decrease by one half.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||hr||Standard Deviation|Mean
2588885|NCT02300025|Primary|Apparent Terminal Elimination Rate Constant (λZ)|λZ was defined as the magnitude of the slope of the linear regression of the log concentration versus time profile during the terminal phase.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||1 per hr (1/hr)||Standard Deviation|Mean
2588886|NCT02300025|Primary|Extrapolated Area Under the Curve (AUC Percent [%] Extrapolated)|AUC% extrapolated was defined as the percentage of AUC [0-∞] obtained by forward extrapolation. It is calculated as [AUC (0-∞) minus AUC(0-t]*100/ AUC (0-∞), where AUC [0-∞] = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUC(0-t) is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||% extrapolated||Standard Deviation|Mean
2588887|NCT02300025|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) was defined as AUC from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t- ∞).|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.|||ng*hr/mL||Standard Deviation|Mean
2588888|NCT02300025|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]|AUC (0-t) was defined as area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).|Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK Population.|||ng*hr/mL||Standard Deviation|Mean
2588889|NCT02300025|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose (0 hrs), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|PK population.|||hrs||Full Range|Median
2588890|NCT02300025|Primary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose (0 hours [hrs]), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, 216, 264, 336, 456, and 576 hrs post-dose|Pharmacokinetic (PK) population included all participants who received at least one dose of cobimetinib and had evaluable PK data.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2588904|NCT02299791|Primary|Patients Indicated for ACE/ARB and Statin Who Had an Active Prescription for Both|Number of patients indicated for ACE/ARB and statin who had an active prescription for both, as a proportion of patients indicated for ACE/ARB and statin.|Percent of clinic patients prescribed guideline-concordant cardioprotective medications, as of the 1st day of each month, from up to 36 months|clinic patients with diabetes who had a clinic encounter (in person or by telephone) within the previous year and were indicated for ACE/ARB and statin per current national care guidelines|||Participants|||Count of Participants
2588905|NCT02299635|Secondary|Number of Notch Genomic Alterations in Participants With NA+ mTNBC|Number of notch genomic alterations identified by NGS assay in patients with NA+ mTNBC|2 years|Data for this outcome measure was not collected due to early termination of this study.||||||
2588906|NCT02299635|Secondary|Number of Participants With Laboratory Test (Urinalysis) Abnormalities|Number of participants with CTCAE version 4.03 grade 1 to 4 urinalysis test abnormalities for urine protein.|Day 1 of Cycle 1|The safety analysis set included all enrolled participants who received at least one dose of study medication.|||participants|||Number
2588907|NCT02299635|Secondary|Number of Participants With Laboratory Test (Chemistry) Abnormalities|Number of participants with CTCAE version 4.03 grade 1 to 4 chemistry test abnormalities|Day 1 and Day 15 of Cycles 1, 2, 3, 4, 5, and subsequent cycles up to Cycle 8 and Day 8 of Cycle 1|The safety analysis set included all enrolled participants who received at least one dose of study medication.|||participants|||Number
2588908|NCT02299635|Secondary|Number of Participants With Laboratory Test (Hematology) Abnormalities|Number of participants with CTCAE version 4.03 grade 1 to 4 hematological test abnormalities.|Day 1 of Cycles 1, 2, 3, 4, 5, and subsequent cycles.|The safety analysis set included all enrolled participants who received at least one dose of study medication.|||participants|||Number
2588909|NCT02299635|Secondary|Number of Participants With Treatment-Emergent AEs by CTCAE Grade|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. AEs were defined according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.|2 years|The safety analysis set included all enrolled participants who received at least one dose of study medication.|||participants|||Number
2588910|NCT02299635|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were defined as all deaths, regardless of cause, from treatment start until 28 days after the last dose and non-fatal events occurring after treatment start regardless of cause, up until 28 days after the last dose or until start of new anti-cancer treatment, whichever was first.|2 years|The safety analysis set included all enrolled participants who received at least one dose of study medication.|||participants|||Number
2588911|NCT02299635|Secondary|Alterations in Genes, Proteins, and RNAs Relevant to the Notch Signaling Pathway, to TNBC Biology, and to Sensitivity/Resistance to PF-03084014 in Tumor Specimens and Peripheral Blood.|Original diagnostic tumor tissue or the most recent metastatic tumor (archival or de novo biopsy), plasma, and peripheral blood samples were collected for biomarker assessments of circulating analytes, immunohistochemistry for notch receptors expression, expression of notch pathway components and modulators, mutational analysis of pathway and disease associated genes.|Day 1 of Cycle 1, 2, 3, and 5|Due to study termination, no PD analyses were performed for this study.||||||
2588912|NCT02299635|Secondary|Pharmacodynamic (PD) Effects of PF‑03084014 in Tumor Specimens and Peripheral Blood|Original diagnostic tumor tissue or the most recent metastatic tumor (archival or de novo biopsy), plasma, and peripheral blood samples were collected for biomarker assessments of circulating analytes, immunohistochemistry for notch receptors expression, expression of notch pathway components and modulators, mutational analysis of pathway and disease associated genes.|Day 1 of Cycle 1, 2, 3, and 5|Due to study termination, no PD analyses were performed for this study.||||||
2588913|NCT02299635|Secondary|Pre-dose Serum Concentration (Ctrough) for PF-03084014||Day 1 of Cycle 1, 2, 3, and 5|Due to study termination, no PK analyses were performed for this study.||||||
2588914|NCT02299635|Secondary|Type of Notch Genomic Alterations in Participants With NA+ mTNBC|Type of notch genomic alterations identified by NGS assay in patients with NA+ mTNBC|2 years|Data for this outcome measure was not collected due to early termination of this study.||||||
2588915|NCT02299635|Secondary|Overall Survival (OS) in Participants With NA+ or NA mTNBC|OS was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact.|2 years|Data for this outcome measure was not collected due to early termination of this study.||||||
2588916|NCT02299635|Secondary|One-Year Survival Probability in Participants With NA+ or NA mTNBC|Overall survival (OS) status (alive or not) at 1 year after study entry. The the survival probability at 1 year was summarized as a product limit estimator based on the Kaplan-Meier method to account for censored events.|1 year|Data for this outcome measure was not collected due to early termination of this study.||||||
2588917|NCT02299635|Secondary|Duration of Response (DR) in Participants With NA+ or NA mTNBC|Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. DR was calculated for the subgroup of patients with a confirmed objective tumor response. Objective Progression (PD): 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.|2 years|Data for this outcome measure was not collected due to early termination of this study.||||||
2588918|NCT02299635|Secondary|Progression-Free Survival (PFS) in Participants With NA+ or NA mTNBC|The period from study entry until disease progression, death, whichever occurred first as per RECIST version 1.1.|2 years|Data for this outcome measure was not collected due to early termination of this study.||||||
2588930|NCT02299388|Other Pre-specified|Change in Catecholamines (Collecting 24 Hrs Urine for Metanephrines and Catecholamines.)|To understand the BP lowering effect of Liraglutide, the investigators will analyse the catecholamines by collecting 24 hrs urine for metanephrines and catecholamines.|Baseline and 8 Weeks||2019-07-31|07/2019||||
2602925|NCT02137603|Primary|Post Operative Length of Stay||Post anesthesia care unit arrival to discharge home, an expected average of up to 48 hours||||Hours||Standard Deviation|Mean
2588919|NCT02299635|Secondary|OR Rate in Participants With mTNBC Whose Tumors Tested Negative for Eenomic Alterations in Notch Receptor (NA-)|OR status based on assessment of confirmed CR or confirmed PR according to RECIST 1.1. CR: Complete disappearance of all target lesions with the exception of nodal disease and all target nodes decreased to normal size (short axis <10 mm). PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. OR=CR+PR.|Cycle 3 Day 1, Cycle 5 Day 1, and every 6 weeks for subsequent cycles ntil disease progression, patient refusal for further follow up, or start of another anti-cancer treatment, whichever occurred first.|Data for this outcome measure was not collected due to early termination of this study.||||||
2588920|NCT02299635|Primary|Objective Response (OR) Rate in Participants With Advanced Triple Receptor-Negative Breast Cancer (mTNBC) Harboring Activating Genomic Alterations in Notch Receptors (NA+)|OR status based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR: Complete disappearance of all target lesions with the exception of nodal disease and all target nodes decreased to normal size (short axis less than [<]10 millimeter [mm]). PR: Greater than or equal to (>=)30% decrease under baseline of the sum of diameters of all target measurable lesions. OR=CR+PR.|Cycle 3 Day 1, Cycle 5 Day 1, and every 6 weeks for subsequent cycles ntil disease progression, patient refusal for further follow up, or start of another anti-cancer treatment, whichever occurred first.|Data for this outcome measure was not collected due to early termination of this study.||||||
2588921|NCT02299570|Secondary|Number of Subjects With Serious Adverse Events Through 24 Months|The number of subjects in each treatment group with serious adverse events will be calculated through 24 months after the last treatment with RBX2660; events will be assessed for seriousness, severity, frequency and causality.|24 months after last treatment with RBX2660|||||||
2588922|NCT02299570|Secondary|Number of Subjects With Adverse Events Through 12 Months|The number of subjects in each treatment group with adverse events will be calculated through 12 months after the last treatment with RBX2660; events will be assessed for seriousness, severity, frequency and causality.|12 months||2019-01-31|01/2019||||
2588923|NCT02299570|Primary|Efficacy of Active Treatment Compared to Placebo at Measured at 8 Weeks Post-treatment|The absence of C. difficile diarrhea without the need for retreatment at 56 days after administration of the last assigned study enema, will be compared between the number of subjects who receive two enemas of RBX2660 to the number of subjects who receive two enemas of placebo.|8 weeks after last assigned study treatment||||Participants|||Count of Participants
2588924|NCT02299479|Secondary|Change From Baseline in Supplemental Carbohydrate Interventions up to 3 Months From Baseline in Subjects With Activity Effect.|For subjects with an activity effect (subjects with a correlation between daytime activity and nighttime nadir glucose), median and inter-quartile range (IQR) of supplemental carbohydrate (SC) interventions (number of SC given by parent divided by the number of nights the SC were given) to prevent hypoglycemia during the study period will be compared to those given during the baseline period for each subject. The median and IQR of this subset of subjects will then be calculated.|Up to 3 months||||Carbohydrate interventions per night||Inter-Quartile Range|Median
2588925|NCT02299479|Secondary|Correlation of Daytime Activity With Nighttime Nadir Glucose.|Daytime activity will be determined based on steps and calories burned measured by activity monitor. High activity is defined as activity level more than 2 standard deviations above the subject's baseline. Correlations will be performed to assess if there is relationship between daytime activity (8 am to 9 pm) and nighttime nadir blood glucose level (mg/dL).|Up to 3 months||||Correlation coefficient||Inter-Quartile Range|Median
2588926|NCT02299479|Primary|Change From Baseline in Supplemental Carbohydrate Interventions up to 3 Months From Baseline.|Median and inter-quartile range (IQR) of supplemental carbohydrate (SC) interventions (number of SC given by parent divided by the number of days the SC were given) to prevent hypoglycemia during the study period will be compared to those given during the baseline period for each subject. The median and IQR of all subjects will then be calculated.|Up to 3 months||||Supplemental Carb (SC) admin. per night||Inter-Quartile Range|Median
2588927|NCT02299427|Primary|Simulated Behavior With Dogs on Standardized Objective Scale|"Coded behavior in dollhouse simulation. Specifically, in 7 simulated scenarios using a dollhouse that included child and dog characters, furniture, yard, etc., children heard a scene and explained/used the dolls to act what would happen next. For example, the experimenter acted a child doll playing in the kitchen near dog food and the doll dog entered, saw the child, and approached the food bowl. The experimenter said, [Child's Name] is playing around in the kitchen near [Dog name's] food. [Dog's name] comes into the kitchen and sees [Child's Name] near his/her food bowl making him/her upset and start to growl. What will happen next? The task was coded using objective coding criteria to score the child's response as safe (1 point), safe but not optimal (0.5 points), or unsafe (0 points). Scores across the 7 scenarios were summed to yield a single score; possible range = 0=7. Higher scores indicate better safety. Inter-rater reliability on 30% of the sample was good; kappa = .90."|post-intervention (about 2 weeks after pre-intervention assessment)|In the dog safety group, only children with known noncompliance were analyzed for this measure|||units on a scale||Standard Deviation|Mean
2588928|NCT02299427|Primary|Children's Behavior With Dogs on Standardized Objective Scale|"Coded behavior using objective criteria during a semi-structured interaction with a live therapy dog. Specifically, we examined behavioral patterns for 15 tasks/activities/decisions the child made with the live dog. Sample tasks were when and how the child touched the dog, the extent to which the child was close or intimate to the dog, whether the child handled the dog's toys, and whether the child interrupted the dog during its rest time. 7 of those hung together in factor analysis. Those 7 were standardized and then averaged to create the scale. It was transformed with linear transformation so all values are positive. Higher numbers indicate higher risk-taking. Theoretically the scale is 0-infinity; in practice most children scored between 0-4. The individual items had an average intercorrelation of .50 and Cronbach's alpha of .65."|post-intervention (about 2 weeks after pre-intervention assessment)|In the dog safety group, only children with known noncompliance were analyzed for this measure|||units on a scale||Standard Deviation|Mean
2588929|NCT02299388|Other Pre-specified|Change in Urinary Sodium Excretion|To understand the BP lowering effect of Liraglutide, the investigators will assess urinary sodium excretion by collecting 24 hours Urine Sodium.|Baseline and 8 Weeks||2019-07-31|07/2019||||
2590952|NCT02277665|Primary|Weeks of Continuous Cannabis Abstinence|Weeks of Continuous Cannabis Abstinence among those achieving at least one week of abstinence|Weeks 1-12|All participants|||weeks||Standard Deviation|Mean
2588931|NCT02299388|Other Pre-specified|Change in Renin-Angiotensin System (Plasma Renin and Aldosterone Levels and Urine Angiotensinogen Levels)|To understand the mechanisms of BP lowering effect of Liraglutide, the investigators will study the effects on Renin Angiotensin system by measuring Plasma renin and aldosterone levels and Urine Angiotensinogen levels (U-AGT-using an assay developed at Tulane Hypertension Center).|Baseline and 8 Weeks||2019-07-31|07/2019||||
2588932|NCT02299388|Other Pre-specified|Change in Autonomic Function (Heart Rate Variability Using Endo PAT.)|To understand the BP lowering effect of Liraglutide, the investigators will study the the autonomic function by assessing the heart rate variability using Endo PAT.|Baseline and 8 Weeks||2019-07-31|07/2019||||
2588933|NCT02299388|Other Pre-specified|Change in Endothelial Function. (Using Endo PAT)|To understand the BP lowering effect of Liraglutide, the investigators will study the Endothelial function - using Endo PAT|Baseline and 8 Weeks||2019-07-31|07/2019||||
2588934|NCT02299388|Secondary|Change in Pulse Pressure, Mean Arterial, Diastolic and Nocturnal Blood Pressures.|"Change in mean arterial blood pressure and diastolic blood pressure from baseline to 8 weeks in the intent-to-treat (ITT) population.~Change in nocturnal BP: the absence of the nocturnal (between 23:00-06:00 hrs) decline in BP of >/= 10% (defined as non-dippers) and whether restoration occurs following Liraglutide therapy.~Change in pulse pressure: defined as the difference in systolic and diastolic BPs from baseline to week 8."|Baseline and 8 Weeks|Only 2 subjects in the placebo group completed 80% ambulatory blood pressure measurements at visits 2 (baseline) and visit 5 (8 weeks). One placebo subject did not have an overall pulse pressure value at week 8 and was eliminated from that outcome analysis.|||mm/Hg||Full Range|Mean
2588935|NCT02299388|Primary|Change in Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitors.|To determine whether Liraglutide lowers systolic BP through the day compared to placebo in patients with T2DM who are not on any anti-hypertensive medications or whose BP medications are unchanged over the study period of 8 weeks.|Baseline and 8 Weeks|Only 2 subjects in the placebo group completed 80% ambulatory blood pressure measurements at visits 2 (baseline) and visit 5 (8 weeks).|||mm/Hg||Full Range|Mean
2588936|NCT02299375|Secondary|Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate mean corpuscle volume. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at the indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Femtoliters||Standard Deviation|Mean
2588937|NCT02299375|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at the Indicated Time Points|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate mean corpuscle hemoglobin. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at the indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Picograms||Standard Deviation|Mean
2588938|NCT02299375|Secondary|Change From Baseline in Red Blood Cell Count at the Indicated Time Points|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate Red blood cell count. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at the indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Trillion cells per liter (TI/L)||Standard Deviation|Mean
2588939|NCT02299375|Secondary|Change From Baseline in Chloride, Calcium, Glucose, Potassium, Sodium and Blood Urea Nitrogen at the Indicated Time Points|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate calcium, chloride, glucose, potassium, sodium and blood urea nitrogenat the indicated time point. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at the indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Millimole (MMOL)/L||Standard Deviation|Mean
2588940|NCT02299375|Secondary|Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase and Gamma Glutamyl Transferase at the Indicated Time Points|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and gamma glutamyl transferase at the indicated time point. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at the indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||International units (IU)/ L||Standard Deviation|Mean
2588957|NCT02299375|Secondary|Time to First Occurrence of Moderate or Severe COPD Exacerbation|The time to first moderate-severe COPD exacerbation in par. treated with losmapimod compared to placebo treated par. was evaluated. The time to the first on-treatment moderate-severe exacerbation was calculated as exacerbation onset date of first on-treatment exacerbation minus exposure start date plus 1. No statistical analysis was conducted. Data was summarized statistically only.|From the start of the study treatment up to 53 Weeks|mITT Population|||Days||Standard Deviation|Mean
2588941|NCT02299375|Secondary|Change From Baseline in Total Bilirubin, Direct Bilirubin, Uric Acid and Creatinine at the Indicated Time Point|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate total bilirubin, direct bilirubin, urice acid and creatinine. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at the indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Micromole (UMOL)/ L||Standard Deviation|Mean
2588942|NCT02299375|Secondary|Change From Baseline in Eosinophil Percentage at the Indicated Time Points|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate eosinophil percentage. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at the indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Percent change||Standard Deviation|Mean
2588943|NCT02299375|Secondary|Change From Baseline in Absolute White Blood Cell (WBC) Count, Total Neutrophil, Total Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Point|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate absolute WBC count, total neutrophil, total lymphocyte, basophil, absolute eosinophil, percentage eosinophil, monocyte and platelet count. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at the indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Giga cells per liter (G/L)||Standard Deviation|Mean
2588944|NCT02299375|Secondary|Change From Baseline in Hematocrit at the Indicated Time Points|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate hematocrit. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||L||Standard Deviation|Mean
2588945|NCT02299375|Secondary|Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points|Blood samples were collected at Baseline (Day 1, pre-dose) and at Weeks 2, 4, 8, 12, 18, 26, 39, 52 (or at early withdrawal) and follow up (Week 53) to evaluate hemoglobin, total protein, albumin and MCHC. Values obtained at Day 1, pre-dose (Week 0) were considered as Baseline values. Change from Baseline was calculated as laboratory test value obtained at indicated time point minus Baseline value. If post-dose value was missing for a particular assessment visit, then no derivation were performed and the change from Baseline were set to missing for that visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Gram (G)/Liter (L)||Standard Deviation|Mean
2588946|NCT02299375|Secondary|Number of Participants With Abnormal Liver Events During the Treatment Period|Various liver chemistry parameters were monitored periodically to ensure the safety and tolerability of Losmapimod as compared to placebo. Study treatments were discontinued for par. if alanine aminotransferase (ALT) absolute >= 5xupper limit of normal (ULN) or; ALT >= 3xULN persists for >=4 Weeks or; ALT>=3x ULN and bilirubin >=2xULN or; ALT>=3x ULN and International normalized ratio (INR) >=1.5 or; ALT>=3x ULN and cannot be monitored weekly for 4 Weeks or; ALT>=3x ULN symptomatic.|Up to Week 53|mITT Population|||Participants|||Number
2588947|NCT02299375|Secondary|Change From Baseline in St Georges Respiratory Questionnaire (SGRQ) Total, SGRQ Symptoms Score, SGRQ Activity Score and SGRQ Impact Score Over Time|SGRQ-C is a health related quality of life questionnaire consisting of 14 questions. SGRQ-C total score was calculated as 100 multiplied by summed weights from all positive items divided by sum of weights for all items in questionnaire. Components (Activity, Symptoms, Impacts) were calculated as 100 multiplied by summed weights from all positive items in that component divided by sum of weights for all items in that component. Score range for SGRQ-C total is 0-100. Maximum weights for Activity, Symptoms and Impacts component is 982.9, 566.2 and 1652.8 respectively. SGRQ-C was transformed to SGRQ for reporting. Higher scores indicate greater disease impact. Score at Day 1, pre-dose (Week 0) was considered as Baseline. Change from Baseline was calculated as score at indicated time point minus Baseline value. Only those par. with analyzable data at the given time points (represented by n=X, X in category titles) were included in analysis.|Baseline and up to Week 52|mITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2588948|NCT02299375|Secondary|Change From Baseline in Frequency of Short Acting Beta-agonist or Anti-cholinergic Use|Use of short acting bronchodilators (short-acting beta2-agonists or short-acting anti-cholinergic) was allowed and was recorded in daily patient diary. It included inhaled short-acting beta2-agonists (e.g. Ipratropium bromide, salbutamol, Ipratropium/salbutamol (albuterol) combination product) and short-acting anti-cholinergics (e.g., ipratropium bromide3). Use of these medications was allowed throughout the study except 4 hours prior to and during each clinic visit. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 52|mITT Population|||Average number of puffs per 24 hours||Standard Deviation|Mean
2589001|NCT02299050|Secondary|Percentage Body Fat|To assess the potential beneficial effect of Cycloset on body fat content|Change from baseline to four to five months||||percentage body fat||Standard Error|Mean
2589002|NCT02299050|Secondary|Body Composition|To assess the potential beneficial effect of Cycloset on body weight composition.|Change from baseline to four to five months||||kg||Standard Error|Mean
2588949|NCT02299375|Secondary|Plasma Losmapimod Maximum Concentration (Cmax) and Lowest Concentration (Ctrough) at Steady State|Pharmacokinetics of losmapimod was evaluated in participants with COPD using PK samples collected at pre-dose at Week 2 and Week 12. At Week 26, a sample was collected at pre-dose and a second sample was collected at 2 hours post-dose. Par. of mITT population that provided at least one observed concentration data in this study were considered for PK analysis (represented by n=X, X in the category titles). Drug plasma concentration-time data were modelled by nonlinear mixed effects modelling to develop a Population PK model. Cmax and Ctrough were estimated from the PK model.|Pre-dose at Weeks 2 and 12; pre-dose and at 2 hours post-dose at Week 26|PK Population.|||ng/ mL||95% Confidence Interval|Geometric Mean
2588950|NCT02299375|Secondary|Plasma Losmapimod Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the End of Dosing Interval (AUC[0-tau])|Pharmacokinetics (PK) of losmapimod was evaluated in participants with COPD using PK samples collected at pre-dose at Week 2 and Week 12. At Week 26, a sample was collected at pre-dose and a second sample was collected at 2 hours post-dose. Par. of mITT population that provided at least one observed concentration data in this study were considered for PK analysis. Drug plasma concentration-time data were modelled by nonlinear mixed effects modelling. AUC[0-tau] (tau=12 hours) was estimated from the model.|Pre-dose at Weeks 2 and 12; pre-dose and at 2 hours post-dose at Week 26|PK Population.|||hour (h)*nanogram (ng)/milliliter (mL)||95% Confidence Interval|Geometric Mean
2588951|NCT02299375|Secondary|Change From Baseline in Heart Rate (HR) Values at the Indicated Time Points|HR was assessed at Screening, Baseline (day 1, pre-dose) and post dose at Weeks 2, 4, 8, 12, 26, 39, 52 and at follow up (Week 53). Measurements were taken in a semi-recumbent position after 5 minutes rest. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the value at day 1, pre-dose. Par. were included in the analysis if they had at least one post-baseline measurement. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Beats per minute (bpm)||Standard Deviation|Mean
2588952|NCT02299375|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points|SBP and DBP were taken at Screening, Baseline (day 1, pre-dose) and post dose at Weeks 2, 4, 8, 12, 26, 39, 52 and at follow up (Week 53). Measurements were taken in a semi-recumbent position after 5 minutes rest. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the value at day 1, pre-dose. Par. were included in the analysis if they had at least one post-baseline measurement. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 53|mITT Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2588953|NCT02299375|Secondary|Number of Participants With Electrocardiogram (ECG) Findings|12-lead ECGs were obtained in triplicate at Screening then singly at Baseline (day 1, pre-dose) and post dose at Weeks 2, 4, 8, 12, 26, 39, 52 and at follow up (Week 53) using an ECG machine that automatically calculates the heart rate (HR) and measures PR, QRS, QT, and QT duration corrected for heart rate by Fridericia's formula (QTcF) or QT duration corrected for heart rate by Bazett's formula (QTcB) intervals. Change in ECG findings were categorized as normal and abnormal. Abnormal ECG values could be clinically significant (CS) or not clinically significant (NCS), as determined by the investigator. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to 53 Weeks|mITT Population|||Participants|||Number
2588954|NCT02299375|Secondary|Change From Baseline in Spirometry Parameters in Pre and Post FEV1/FVC, Percent Predicted (PP) FEV1, PP FEV6 and PP FVC|Pre and post FEV1/FVC, PP FEV1, PP FEV6 and PP FVC were assessed at Screening, Day 1 pre-dose and Weeks 2, 4, 8, 12, 18, 26, 39 and 52. Par. were asked to withheld all bronchodilator therapy included ipratropiumn bromide and salbutamol/albuterol for at least 4 hours prior to the prebronchodilator spirometric test. Post-bronchodilator spirometric assessment was performed after inhalation of 400/360 µg of salbutamol/albuterol in 10-15 minutes. Day 1 (pre-dose) values were considered as Baseline values. Change from Baseline was calculated as value at indicated time point minus Baseline value. The maximum value of the 3 replicate assessments were used. Analysis performed using a mixed-effects repeated measures model. The adjusted mean values were summarized per treatment group. Par. were included in the analysis if they had at least one post-baseline measurement. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 52|mITT Population.|||Percentage||Standard Error|Mean
2588955|NCT02299375|Secondary|Change From Baseline in Spirometry Parameters in Pre and Post Forced Expiratory Volume in 1 Second (FEV1); Pre and Post Forced Vital Capacity (FVC); Pre and Post Forced Expiratory Volume in 6 Seconds (FEV6).|Pre and post FEV1, FVC and FEV6 were performed at Screening, Day 1 pre-dose and Weeks 2, 4, 8, 12, 18, 26, 39 and 52. Par. were asked to withheld all bronchodilator therapy included ipratropiumn bromide and salbutamol/albuterol for at least 4 hours prior to prebronchodilator spirometric test. Post-bronchodilator spirometric assessment was performed after inhalation of 400/360 micograms (µg) of salbutamol/albuterol in 10-15 minutes. Day 1 (pre-dose) values were considered as Baseline values. Change from Baseline was calculated as value at the indicated time point minus Baseline value. The maximum value of the 3 replicate assessments were used. Analysis performed using a mixed-effects repeated measures model. The adjusted mean values were summarized per treatment group. Par. were included in the analysis if they had at least one post-baseline measurement. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 52|mITT Population|||Liters||Standard Error|Mean
2588956|NCT02299375|Secondary|Number of Participants Having Any Adverse Events (AEs), Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. AEs were considered as on-treatment If AE onset date is on or after treatment start date & on or before treatment stop date. par. having any AE or SAE were included in analysis.|From the start of the study treatment up to 53 Weeks|mITT Population|||Participants|||Number
2588958|NCT02299375|Primary|Annual Rate of Moderate and Severe Exacerbations of COPD|An exacerbation of COPD, is defined as the worsening of 2 or more major symptoms (dyspnea, sputum volume, sputum purulence) or the worsening of any 1 major symptom together with any 1 of the minor symptoms (sore throat, cold, fever without other cause, increased cough and wheeze), for at least 2 consecutive days. Moderate-severe exacerbations were defined as use of antibiotics and/or oral steroids and/or hospitalization. Summary only included exacerbations for which a date of resolution or death was provided. Analysis was performed by using Bayesian inference assuming non-informative priors. The mean exacerbation rate was adjusted for treatment group, smoking status, ICS use and region. The adjusted posterior median was summarized per treatment group. The number of exacerbation events per participant was assumed to follow a negative binomial distribution. Modified Intent-to-Treat (mITT) Population comprised of all randomized par. who received at least one dose of study treatment.|From the start of the study treatment up to 53 Weeks|mITT Population|||Exacerbations per participant per year||Standard Deviation|Median
2588959|NCT02299349|Secondary|MS04 Equivalent Consumption|in hospital total MS04 equivalent consumption|1 day following surgery||||mg||Inter-Quartile Range|Median
2588960|NCT02299349|Primary|Pain Scores (Visual Analog Pain Scores)|visual analog pain scores (scale 0=no pain; 10=worst pain imaginable)|1 day following surgery||||units on a scale||Standard Deviation|Mean
2588961|NCT02299336|Secondary|Role of (Ultrawide-field, if Available) Fluorescein Angiography-determined Retinal Ischemia in Predicting Anatomic Outcomes|Mean change in central retinal thickness from baseline to week 52 based on quantification of ischemic areas|Week 52, Week 104|This analysis was never performed because we were logistically unable to collect the data.||||||
2588962|NCT02299336|Secondary|Role of (Ultrawide-field, if Available) Fluorescein Angiography-determined Retinal Ischemia in Predicting Visual Outcomes|Mean change in visual acuity from baseline to week 52 and baseline to week 104 based on quantification of ischemic areas|Week 52, Week 104|This analysis was never performed because we were logistically unable to collect the data.||||||
2588963|NCT02299336|Secondary|Role of (Ultrawide-field, if Available) Fluorescein Angiography-determined Retinal Ischemia in Predicting Past and Future Anti-VEGF Treatment Burden|Mean number of injections in 52 weeks and 104 weeks based on quantification of ischemic areas|Week 52, Week 104|This analysis was never performed because we were logistically unable to collect the data.||||||
2588964|NCT02299336|Secondary|Mean Change in Central Retinal Thickness Before and After First Focal Laser Treatment|Evaluate the mean change in central retinal thickness before and after first focal laser treatment in patients treated with pro re nata aflibercept.|104 weeks|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||microns||Standard Error|Mean
2588965|NCT02299336|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity Before and After Focal Laser Therapy|Evaluation of the effect of laser on Early Treatment Diabetic Retinopathy Study best-corrected visual acuity outcomes. Participants were challenged with reading letters on lines of an eye chart (5 letters per line) in standardized lighting conditions. Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.|104 weeks|All participants receiving laser were included in analysis.|||letters||Standard Deviation|Mean
2588966|NCT02299336|Secondary|Number of Subjects That Receive Focal Laser Treatment.|Number of subjects that receive focal laser treatment from baseline to week 52 and from baseline to week 104.|Week 52, Week 104|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||Participants|||Count of Participants
2588967|NCT02299336|Secondary|Number of Subjects With Stable, Worsened, or Improved Diabetic Retinopathy|Number of subjects with stable, worsened, or improved diabetic retinopathy through 104 weeks.|Week 52, Week 104|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||Participants|||Count of Participants
2588968|NCT02299336|Secondary|Number of Subjects With no Clinically-relevant Diabetic Macular Edema (as Defined in the Protocol) on Spectral Domain Optical Coherence Tomography From Baseline to Week 52 and Baseline to Week 104.|Evaluate the number of subjects with no clinically-relevant diabetic macular edema (as defined in the protocol) on spectral domain optical coherence tomography from baseline to week 52 and baseline to week 104 in patients treated with aflibercept.|Week 52, Week 104|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||Participants|||Count of Participants
2588969|NCT02299336|Secondary|Mean Change in Central Retinal Thickness From Baseline to Week 52 and Baseline to Week 104.|Evaluate the mean change in central retinal thickness from baseline to week 52 and baseline to week 104 in patients treated with aflibercept.|Week 52, Week 104|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||Microns||Standard Error|Mean
2588970|NCT02299336|Secondary|Percentage of Subjects With Gain or Loss of 0 to 5 Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity Letters From Baseline to Week 52 and Baseline to Week 104|Evaluate the percentage of subjects with a gain or loss in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity letters in patients treated with aflibercept from baseline to week 52 and baseline to week 104|Week 52, Week 104|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||Participants|||Count of Participants
2589003|NCT02299050|Secondary|Endothelial Function,|To assess the potential beneficial effect of Cycloset on endothelial function. This is measured by using pulse pressure.|Change from baseline to four to five months||||mmHg||Standard Error|Mean
2588971|NCT02299336|Secondary|Mean Number of Intravitreal Aflibercept Injections Before and After Receiving First Focal Laser Application.|Measure the role of focal laser treatment (fluorescein angiography-guided, if applicable) in decreasing the treatment burden among subjects who require ongoing aflibercept treatment in the management of diabetic macular edema.|Before First Focal Laser Treatment (FLT) at Week 12 or later; After First FLT at up to 104 weeks|Only participants who were eligible for focal laser treatment were analyzed.|||Injections||Standard Deviation|Mean
2588972|NCT02299336|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity From Baseline to Week 52 and Baseline to Week 104|Evaluate the mean change over time in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity at week 52 from baseline and at week 104 from baseline. Participants were challenged with reading letters on lines of an eye chart (5 letters per line) in standardized lighting conditions. Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.|Week 52, Week 104|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||letters||Standard Error|Mean
2588973|NCT02299336|Primary|Mean Number of Intravitreal Aflibercept Injections for Subjects Who Were Enrolled and Completed the 3-year VISTA DME (VGFT-OD-1009) Trial|Measured by evaluating mean number of injections required for subjects who were enrolled and completed the 3-year VISTA DME (VGFT-OD-1009) trial|Week 104||||injections||Standard Error|Mean
2588974|NCT02299297|Secondary|Dermatology Life Quality Index (DLQI) Score|The first dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire used to evaluate patient's quality of life. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.|Up to 24 weeks||||score on a scale||Standard Deviation|Mean
2588975|NCT02299297|Secondary|Percentage of Regrowth|Percentage of regrowth was measured by comparing the SALT score at the beginning and end of treatment.|Baseline up to between 24 and 72 weeks||||percentage of regrowth||Full Range|Mean
2588976|NCT02299297|Secondary|Total Number of Responders With Change in PHYSICIAN Global Assessment Score|A physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe). Responders are defined by participants who exhibited regrowth.|Up to 24 weeks||||Participants|||Count of Participants
2588977|NCT02299297|Secondary|Total Number of Responders Maintaining Response During the Post-Treatment Follow Up Period|To assess the durability of responses, patients who achieve 50% regrowth from baseline during the first 6 to 18 months, will continue to be followed for an additional 6 months post-treatment or until it is determined that relapse has occurred. Durability of response was measured by comparing SALT scores from baseline to 24 weeks after treatment.|Week 24||||Participants|||Count of Participants
2588978|NCT02299297|Primary|Total Number of Responders|This is defined as 50% or greater hair re-growth from baseline as assessed by the Severity of ALopecia Tool (SALT) score after up to 24 weeks/6 months to 72 weeks/18 months of treatment. This is a relatively strict definition for defining responders and non-responders and was chosen to minimize the potential for spontaneous remission, in which fewer than 10% are expected to achieve this magnitude of hair regrowth spontaneously.|Baseline up to between 24 and 72 weeks||||Participants|||Count of Participants
2588979|NCT02299258|Secondary|Adverse Events|bleeding, abdominal pain|up to 5 years||||participants|||Number
2588980|NCT02299258|Primary|Efficiency of Stents|number of participants considered having efficacious outcome. Efficacy is defined by Ingrowth + overgrowth in this study|up to 5 years||||participants|||Number
2588981|NCT02299206|Secondary|Parent/Caregiver Rating of Satisfaction With Use of the Product|Parents/caregivers will be given a questionnaire rating the use of the study products.|14 days|Study was terminated prior to analysis due to low enrollment.||||||
2588982|NCT02299206|Secondary|Assessment of Tolerability by the Infant|Parent/caregivers will be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a VAS severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level|14 days|Study was terminated prior to analysis due to low enrollment.||||||
2588983|NCT02299206|Secondary|Parents/Caregivers Daily Scores Through Duration of the Study Period|Parent/caregivers will be asked to complete a daily diary that asks about changes in their baby's diaper dermatitis, a Visual Analogue Scale severity assessment of their baby's diaper dermatitis, and observations related to product use and the baby's comfort level|14 days|Study was terminated prior to analysis due to low enrollment.||||||
2588984|NCT02299206|Secondary|Change in Physician Assessment Diaper Dermatitis Scores to Day 7|For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared.|7 days|Study was terminated prior to analysis due to low enrollment.||||||
2588985|NCT02299206|Primary|Change From Baseline for the Physician Assessment Diaper Dermatitis Scores to Day 14 for Each Treatment Group.|For each visit the study doctor will assess the diaper dermatitis severity with a Diaper Dermatitis Severity Score tool. In Addition, location of clinically apparent involved area will be shaded by hand onto diagram by the research personnel. Scores will be compared.|14 days|Study was terminated prior to analysis due to low enrollment.||||||
2588986|NCT02299089|Other Pre-specified|To Assess the Symptoms of Carcinoid Syndrome (Number of Bowel Movements and Flushing) and the Use of Rescue Medication Versus Baseline (by Using Patient Diaries) (NET)|"Number of bowel movements and flushing during period 0 and 1, data is presented as patients experience symptoms~Bowel movement without flushing Bowel movement and flushing No Bowel movement or Flushing"|Baseline (Day 0), Day 84|Pharmacokinetic population|||participants|||Number
2588987|NCT02299089|Secondary|CAM2029 Effect on Growth Hormone (GH) (Acromegaly)|GH (growth hormone) levels measured on Day 84 in patients with acromegaly|Day 84|Pharmacokinetic population (5 acromegaly patients)|||participants|||Number
2589421|NCT02292849|Primary|Number of Peer to Peer Clients Who Attend > 80% of Behavioral Activation Sessions|Number of Peer to Peer clients who attend > 80% of Behavioral Activation sessions|12 weeks|Clients assigned to receive Peer BA|||Participants|||Count of Participants
2588988|NCT02299089|Secondary|CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly)|"Data is presented as number of patients~Within the reference limits (see below)~Above ULN (Upper Limits of Normal)~In the Acromegaly group both males and females were included the age was between 42-70 years. The IGF normal range for the different genders and age are presented below.~REFERENCE VALUES~Males (NMOL/L) 8.34-27.44 (41-45 years) 7.7-26.36 (46-50 years) 7.3-26.34 (51-55 years) 6.64-25.44 (56-60 years) 6.17-25.02 (61-65 years) 5.96-25.48 (66-70 years)~Females (NMOL/L) 8.06-26.89 (41-45 years) 7.39-25.44 (46-50 years) 6.92-24.98 (51-55 years) 5.92-22.7 (56-60 years) 5.42-21.96 (61-65 years) 5.07-21.97 (66-70 years)"|Day 84|Pharmacokinetic population (5 acromegaly subjects total)|||participants|||Number
2588989|NCT02299089|Secondary|Number of Adverse Events and Serious Adverse Events|Safety (number of adverse events and serious adverse events) after repeated doses of CAM2029 (assessment period from Day 0 to Day 84) and single dose Sandostatin LAR (assessment period Day -28 to Day 0)|Day -28 to Day 84|Safety population (n=12). Patients treated with Sandostatin LAR Day -28 to 0 and CAM2029 (Day 0 to Day 84)|||Participants|||Count of Participants
2588990|NCT02299089|Primary|Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax.|"Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84 ; Cmax (ng/mL).~Cmax (ng/mL): Maximum observed plasma concentration over CAM2029 20 mg q4w and CAM2029 10 mg q2w dosing intervals (ng/mL)"|(Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)|Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.|||ng/mL||Standard Deviation|Mean
2588991|NCT02299089|Primary|Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough|"Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84; Ctrough (ng/mL).~Ctrough; Concentration levels assessed prior to next injection for CAM2029 20 mg q4w and CAM2029 10 mg q2w dosing intervals (ng/mL)"|(Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)|Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.|||ng/ml||Standard Deviation|Mean
2588992|NCT02299089|Primary|Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax|"Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; Cmax (ng/mL).~Cmax (ng/mL): Maximum observed plasma concentration over the final (Sandostatin LAR) dosing interval (ng/mL)"|Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)|Pharmacokinetic population|||ng/mL||Standard Deviation|Mean
2588993|NCT02299089|Primary|Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough|"Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; Ctrough (ng/mL).~Ctrough; Concentration levels assessed prior to next injection for the final (Sandostatin LAR) dosing interval (ng/mL)."|Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)|Pharmacokinetic population|||ng/mL||Standard Deviation|Mean
2588994|NCT02299089|Primary|Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC.|"Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84 ; AUC0-28d (day*ng/mL).~AUC0-28d: AUC from 0 to 28 days over the dosing intervals (day*ng/mL) for CAM2029 20 mg q4w and CAM2029 10 mg q2w (to estimate AUC0-28d for those patients receiving CAM2029 10 mg q2w, AUC0-14d was multiplied by a factor of 2 as an estimate of the AUC0-28d) dosing intervals"|(Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)|Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.|||day*ng/mL||Standard Deviation|Mean
2588995|NCT02299089|Primary|Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC|"Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; AUC0-28d (day*ng/mL).~AUC0-28d: AUC from 0 to 28 days over the final dosing interval (day*ng/mL) for Sandostatin LAR."|Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)|Pharmacokinetic population|||day*ng/mL||Standard Deviation|Mean
2588996|NCT02299076|Primary|Outcome of Smoking Cessation Intervention|Quit levels for the intervention will be higher relative to the control arm. Quit level is defined as a participant who progresses to the stage in the tobacco cessation program where they quit smoking. The quit stages are levels 4 and 5 of the tobacco cessation program.|Every 30 days for up to 6 months post-enrollment||||Participants|||Count of Participants
2588997|NCT02299076|Primary|Average Number of Completed Sessions Per Participant|Engagement rates for the intervention will be higher relative to the control arm. Engagement is measured by the number of complete tobacco cessation sessions per participant.|Every 30 days for up to 6 months post-enrollment||||Average Number of Sessions|Sessions|Inter-Quartile Range|Mean
2588998|NCT02299050|Secondary|Arterial Stiffness (AS)|To assess the potential beneficial effect of Cycloset on arterial stiffness. Arterial stiffness is calculated by the measurement of pulse pressure, where Pulse pressure = SBP - DBP (Where SBP is systolic blood pressure and DBP is diastolic blood pressure) The calculated value is used as a predictor of cardiovascular disease. Higher values indicate that cardiovascular disease is more likely.|Change from baseline to four to five months||||au (arbitrary units)||Standard Error|Mean
2588999|NCT02299050|Secondary|Mean Arterial Blood Pressure|To assess the potential beneficial effect of Cycloset on change in mean arterial blood pressure|Change from baseline to four to five months||||mmHg||Standard Error|Mean
2589000|NCT02299050|Secondary|Blood Pressure|To assess the potential beneficial effect of Cycloset on blood pressure.|Change from baseline to four to five months||||mmHg||Standard Error|Mean
2589004|NCT02299050|Primary|Glucose Metabolism During Mixed Meal Tolerance Test|The objective of this study is to examine the effect of the addition of Cycloset on glycemic control in inadequately controlled (HbA1c 7.5-10.0) T2DM patients who are already on Bydureon (exenatide once weekly) or Victoza (liraglutide ) as part of their standard care.|Change from baseline to four to five months||||mg/kg *min||Standard Error|Mean
2589005|NCT02299050|Primary|HbA1C|"The objective of this study is to examine the effect of the addition of Cycloset on glycemic control in inadequately controlled (HbA1c 7.5-10.0) T2DM (type 2 diabetes mellitus) patients who are already on Bydureon (exenatide once weekly) or Victoza (liraglutide ) as part of their standard care.~An additional co-primary objective of the study is to examine the effect of Cycloset on postprandial glucose metabolism."|Change from baseline to four to five months||||mmol/mol||Standard Error|Mean
2589006|NCT02298946|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of AMP-224|Time maximum drug absorption is reached in the blood following administration of AMP-224.|12.7 hours following intravenous (IV) infusion.|Data was collected and not analyzed because the outside laboratory declined to run specimens with a negative clinical trial.||||||
2589007|NCT02298946|Secondary|Area of the Curve (AUC) of AMP-224|The AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. The lower limit of quantification (LLOQ) is the smallest concentration of the drug that can be reliably measured.|Pre and post-infusion with all the AMP infusion and Day 1 at 8, 15, 29, 43, 57, and 71 hours.|Data was collected and not analyzed because the outside laboratory declined to run specimens with a negative clinical trial.||||||
2589008|NCT02298946|Secondary|Terminal Elimination Half-Life of AMP-224|Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.|10 days|Data was collected and not analyzed because the outside laboratory declined to run specimens with a negative clinical trial.||||||
2589009|NCT02298946|Secondary|Immunogenicity of AMP-224 as Measured by Human Anti-Murine Antibodies (HAMA) and Human Anti-Chimeric Antibodies (HACA) Concentrations|Blood samples were collected to measure HAMA and HACA concentrations using the ELISA method in all patients.|Baseline, D1, D29, and D57 (pre-infusion), D79, D85 and 90 days post last dose (D169)|Data was collected and not analyzed because the outside laboratory declined to run specimens with a negative clinical trial.||||||
2589010|NCT02298946|Secondary|Objective Response Rate|"Objective response will be evaluated according to the revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and is defined as Complete Response + Partial Response. Briefly, complete response (CR) is defined as the disappearance of all target lesions, and Partial Response is defined as at least 30% decrease in the sum of the diameters of the target lesions from baseline measurement."|Restaging was done every 8 weeks for an average of 2.6 months.|All patients had restaging evaluations completed as per protocol. Response criteria in solid tumors(RECIST) were completed on every trial participate. No partial or complete responses were found in any patients.|||percentage of participants|||Number
2589011|NCT02298946|Secondary|Median Progression-free Survival in Patients With Colorectal Cancer|Progression free survival is defined as the time interval from start of treatment to documented evidence of disease progression. Disease progression was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).|Baseline to disease progression, an average of 2.6 months.||||months||95% Confidence Interval|Median
2589012|NCT02298946|Secondary|Count of Participants With Post-Treatment Biopsies|Mandatory post treatment biopsies of the tumor were attempted on all patients.|Post treatment, day 29 +/- 7 days||||Participants|||Count of Participants
2589013|NCT02298946|Secondary|Overall Survival in Patients With Colorectal Cancer Following Treatment With AMP-224 in Combination With SBRT|Overall survival is defined as the time from treatment start date until date of death or date last known alive.|Baseline to end of study, which is date of death. Average time participants were followed was 10.6 months.|Patients were follow up post completion of the treatment medications for survival until date of their death. 2 patients were not evaluable since they did not receive treatment. 1 patient was lost to follow up after 3 cycles of treatment due to brain metastasis and treatment in another state.|||months||95% Confidence Interval|Median
2589014|NCT02298946|Secondary|Number of Participants in Which Specimens Were Collected for Pre and Post Pharmacokinetic (PK) AMP-224 Analyses|This outcome measure only represents the number of participants with metastatic colorectal cancer who had specimens collected for pre and post pharmacokinetic (PK) AMP-224 analyses.|Baseline and post infusion AMP-224 (e.g. 15 minutes after infusion ended)||||Participants|||Count of Participants
2589015|NCT02298946|Secondary|Duration of Response in Patients With Colorectal Cancer During and Following Treatment With AMP-224 in Combination With SBRT|Duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is complete disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|12 months|Zero participants were analyzed because no participants experienced a CR or PR.||||||
2589030|NCT02298842|Secondary|Percent of Platelets Activated as Measured by P-selectin|Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality.|Day 7|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||Percent of Platelets Activated||Standard Deviation|Mean
2589125|NCT02296775|Secondary|Time to Cmax (Tmax) After Second Dose|Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI), 6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) , and 168 hours (post-EOI).|2 weeks|Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=224|||Hours||Full Range|Median
2589016|NCT02298946|Primary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 24 months and 8 days|One patient (on dose level 1) after signing consent while waiting for radiation dosing, developed a spinal cord compression that needed emergent care at the local hospital. This patient was not treated. One patient (on dose level 1) after signing consent, developed a bowel obstruction prior to treatment.|||Participants|||Count of Participants
2589017|NCT02298933|Primary|Number of Subjects With Sustained Platelet Transfusion Responsiveness|To evaluate the safety and efficacy of eculizumab to increase the platelet increment, defined as Corrected Count Increment (CCI) >7500/μL at 10-60 min together with CCI>5000/μL at 18-24 hrs post transfusion in patients with platelet refractoriness following treatment with eculizumab and platelet transfusion.|24 hours|All patients were given Eculizumab|||Participants|||Count of Participants
2589018|NCT02298868|Secondary|Change in Severity of Muscle Cramps After Washout Period|Subjects undertook a muscle cramp questionnaire prior to treatment that measured severity on a 0-10 analog scale (0 is no pain, 10 is most severe pain) and repeated this measure at the end of baclofen therapy (end of week 4). Subjects then underwent a 1 week taper of baclofen and a subsequent two week washout period. At the end of the washout period (end of week 7) the subjects underwent a final muscle cramp questionnaire to reassess severity of muscle cramps. This was then compared to the end of therapy severity to document the increase in muscle cramps after stopping baclofen. (week 7 result - week 4 result)|End of treatment (week 4) to end of washout (week 7)||||units on a scale||Standard Deviation|Mean
2589019|NCT02298868|Secondary|Change in Frequency of Muscle Cramps After Washout Period|Subjects undertook a muscle cramp questionnaire prior to treatment that measured frequency in the number of days in a week that a subject experienced muscle cramps and repeated this measure at the end of baclofen therapy (end of week 4). Subjects then underwent a 1 week taper of baclofen and a subsequent two week washout period. At the end of the washout period (end of week 7) the subjects underwent a final muscle cramp questionnaire to reassess frequency of muscle cramps. This was then compared to the end of therapy frequency to document the increase in muscle cramps after stopping baclofen. (week 7 result - week 4 result)|End of treatment (week 4) to end of washout (week 7)||||days/week||Standard Deviation|Mean
2589020|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Somnolence)|Proportion of patients with somnolence at any time during the 4 weeks of therapy|4 weeks of active therapy||||participants|||Number
2589021|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Encephalopathy)|Proportion of patients with endephalopathy at any time during the 4 weeks of therapy|4 weeks of active therapy||||participants|||Number
2589022|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Dizziness)|Proportion of patients with dizziness at any time during the 4 weeks of therapy|4 weeks of active therapy||||participants|||Number
2589023|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Nausea)|Proportion of patients with nausea at any time during the 4 weeks of therapy|4 weeks of active therapy||||participants|||Number
2589024|NCT02298868|Secondary|Efficacy of Baclofen to Change Severity of Muscle Cramps in Patients With Cirrhosis After 4 Weeks of Therapy|Patients undertook a muscle cramp questionnaire prior to treatment that measured severity in a 0-10 analog scale (0 is no pain and 10 is most severe pain). These measures were repeated after 4 weeks of therapy and the difference was assessed (4 weeks of therapy-Baseline).|Baseline to end of 4 weeks of therapy||||units on a scale||Standard Deviation|Mean
2589025|NCT02298868|Secondary|Efficacy of Baclofen to Change Frequency of Muscle Cramps in Patients With Cirrhosis at the End of 4 Weeks of Therapy|Patients undertook a muscle cramp questionnaire prior to treatment that measured frequency in the number of days in a week that a subject experienced muscle cramps. This measures was repeated after 4 weeks of therapy and reported as the mean decrease in frequency of muscle cramps (4 weeks of therapy-Baseline).|Baseline to 4 weeks of therapy||||days/week||Standard Deviation|Mean
2589026|NCT02298868|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Headache)|Proportion of patients with headache at any time during the 4 weeks of therapy|4 weeks of active therapy||||participants|||Number
2589027|NCT02298842|Secondary|Platelet Morphology|Quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher values represent healthier platelets.|Day 7|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||score on a scale||Standard Deviation|Mean
2589028|NCT02298842|Secondary|Percent of Platelets Exhibiting Hypotonic Shock Response|Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality.|Day 7|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||% of hypotonic shock response||Standard Deviation|Mean
2589029|NCT02298842|Secondary|Percent of Extent of Shape Change|Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality. Higher value is considered to indicate better platelet quality.|Day 7|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||% of extent of shape change||Standard Deviation|Mean
2589031|NCT02298842|Secondary|Platelet Morphology|Quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher values represent healthier platelets.|Day 5|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||scores on a scale||Standard Deviation|Mean
2589032|NCT02298842|Secondary|Percent of Platelets Exhibiting Hypotonic Shock Response|Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality.|Day 5|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||% of hypotonic shock response||Standard Deviation|Mean
2589033|NCT02298842|Secondary|Percent of Extent of Shape Change|Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality.|Day 5|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||% extent of shape change||Standard Deviation|Mean
2589034|NCT02298842|Secondary|Percent of Platelets Activated as Measured by P-selectin|Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality.|Day 5|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||Percent of Platelets Activated||Standard Deviation|Mean
2589035|NCT02298842|Primary|pH of Platelets at Day 7|The primary endpoint for this study is pH of platelets stored in InterSol at Day 7. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.|Day 7|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||pH||Standard Deviation|Mean
2589036|NCT02298842|Primary|pH of Platelets at Day 5|The primary endpoint for this study is pH of platelets stored in InterSol at Day 5. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.|Day 5|The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.|||pH||Standard Deviation|Mean
2589037|NCT02298803|Secondary|deltaQTc|deltaQTc is the difference in QTc observed during periods of hypoglycemia and periods of normoglycemia (for those participants who experienced nocturnal hypoglycemia)|Nocturnal time period (2300-0700) during the 48 hours of Holter monitoring||||milliseconds|||Number
2589038|NCT02298803|Secondary|Mean Amplitude of Glycemic Excursion (MAGE)|The MAGE results (in mmol/L) for the eight participants who experienced nocturnal hypoglycemia are included in the table below.|48 hours of continuous glucose monitoring|Only those participants who experienced nocturnal hypoglycemia (BGL <3.5 mmol/L for >20 minutes) are included in the analysis population|||mmol/L|||Number
2589039|NCT02298803|Secondary|Pearson's Correlation Coefficient of Delta QTc and a Measure of Glucose Variability, MAGE (Mean Amplitude of Glycemic Excursion).|MAGE, a commonly used index of glucose variability, was calculated using data obtained during continuous glucose monitoring. Analysis of correlation between MAGE and delta QTc was undertaken. Please note delta QTc represents the difference between average QTc length during hypoglycemia and average QTc length during normoglycemia.|Nocturnal time period (2300-0700) during the 48 hours of Holter monitoring|The eight study participants who experienced nocturnal hypoglycemia are included in the analysis population.|||Correlation coefficient|||Number
2589040|NCT02298803|Primary|Change in Corrected QT Interval During Day Time Hypoglycaemia|The day time period for the study spanned from 7 am in the morning until 11 pm in the evening on two consecutive days. The change in the corrected QT interval during day time hypoglycemia was determined by calculating the difference between the average QTc interval length during periods of hypoglycemia (blood glucose level <3.5 mmol/L) and the average QTc interval length during periods of normoglycemia (blood glucose level >3.5 mmol/L) for the day time period. The average QTc interval was calculated using an individually optimised correction formula. If the result of average QTc (hypoglycemia) - average QTc (normoglycemia) was positive, the participant experienced QTc prolongation during hypoglycemia. If the result of average QTc (hypoglycemia) - average QTc (normoglycemia) was negative, the participant experienced QTc shortening during hypoglycemia.|Day time period (0700-2300) during the 48 hours of Holter monitoring||||Participants|||Count of Participants
2589041|NCT02298803|Primary|Change in the Corrected QT-interval During Nocturnal Hypoglycemia|The nocturnal time period for the study spanned from 11 pm in the evening until 7 am the following morning on two consecutive days. The change in the corrected QT interval during nocturnal hypoglycemia was determined by calculating the difference between the average QTc interval length during periods of hypoglycemia (blood glucose level <3.5 mmol/L) and the average QTc interval length during periods of normoglycemia (blood glucose level >3.5 mmol/L) for the nocturnal time period. The average QTc interval was calculated using an individually optimised correction formula. If the result of average QTc (hypoglycemia) - average QTc (normoglycemia) was positive, the participant experienced QTc prolongation during hypoglycemia. If the result of average QTc (hypoglycemia) - average QTc (normoglycemia) was negative, the participant experienced QTc shortening during hypoglycemia.|Nocturnal time period (2300-0700) during the 48 hours of Holter monitoring||||Participants|||Count of Participants
2589126|NCT02296775|Secondary|Time to Cmax (Tmax) After First Dose.|Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI), 6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) , and 168 hours (post-EOI).|2 weeks|Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=218|||Hours||Full Range|Median
2589042|NCT02298361|Primary|Proportion of Patients Who Lost Medicaid Coverage|Proportion of participants who lost Medicaid coverage after a period of insurance. Assessed using state administrative records linked to EHR data; this outcome was assessed among the subset of participants with a Medicaid ID (and thus could be linked between the two data sources) and who had partial coverage during the study period (i.e., patients with 100% coverage were not 'eligible' to lose coverage).|6 months pre- through 16 months post-tool implementation||||participants|||Number
2589043|NCT02298361|Primary|Proportion of Patients Who Gained Medicaid Coverage|Proportion of participants who gained Medicaid coverage after a period of uninsurance. Assessed using state administrative records linked to EHR data; this outcome was assessed among the subset of participants with a Medicaid ID (and thus could be linked between the two data sources) and who had partial coverage during the study period (i.e., patients with 100% coverage were not 'eligible' to gain coverage).|6 months pre- through 16 months post-tool implementation||||participants|||Number
2589044|NCT02298361|Primary|Percent of Study Period Covered by Medicaid|Percent of total days in 22-month assessment period that each child was covered by Medicaid insurance. Assessed using state administrative records linked to EHR data; this outcome was assessed among the subset of participants with a Medicaid ID (and thus could be linked between the two data sources).|6 months pre- through 16 months post-tool implementation||||participants|||Number
2589045|NCT02298192|Secondary|Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes|An episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Week 0-32|"Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation “as treated. One subject in the IDegLira (1WT) arm did not contribute to the analysis for this endpoint."|||Number of episodes|||Number
2589046|NCT02298192|Secondary|HbA1c Below or Equal to 6.5%|Responders to HbA1c below or equal to 6.5% after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.|||particpants|||Number
2589047|NCT02298192|Secondary|HbA1c Below 7.0%|Responders to HbA1c below 7% after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.|||participants|||Number
2589048|NCT02298192|Primary|Change From Baseline in HbA1c|Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) included all randomised subjects. 20 subjects in the IDegLira (1WT) and 10 subjects in the IDegLira arm did not contribute to the analysis for this endpoint.|||percentage||Standard Deviation|Mean
2589049|NCT02298179|Secondary|Ratio of RSV F Serum Nab Titers to Each of the RSV F Serum Total Binding Antibody Titers to RSV Proteins F, G and N|Immunogenicity was measured in terms of the ratio of RSV F serum Nab titers to each of the RSV F serum total binding antibody titers to RSV proteins F, G and N at Days 1, 29, 57 and 181.|At Day 1, Day 29, Day 57 and Day 181|The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29, Day 57 and Day 181.|||Adjusted Geometric Mean Ratio||95% Confidence Interval|Geometric Mean
2589050|NCT02298179|Secondary|Percentage of Subjects With Serum Total Binding Antibody Titers to Each of the RSV Proteins F, G, and N Greater Than the 3rd Quartile of Serum Total Binding Antibody Titers to RSV Protein F at Day 1|Immunogenicity was measured in terms of the percentage of subjects at Day 29 (28 days after the first dose), Day 57 (28 days after the second dose) and Day 181 (six months after the first dose), with serum total binding antibody titers to each of the RSV proteins F, G, and N greater than the 3rd quartile of serum total binding antibody titers to RSV protein F at Day 1 (baseline).|At Day 29, Day 57 and Day 181|The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29, Day 57 and Day 181.|||Percentage of subjects||95% Confidence Interval|Number
2589051|NCT02298179|Secondary|Percentage of Subjects With a ≥ 4-fold Increase in Serum Total Binding Antibody to Each of the RSV Proteins F, G and N|Immunogenicity was measured in terms of the percentage of subjects with a ≥ 4-fold increase in serum total binding antibody to each of the RSV Proteins F, G and N from Day 1 (baseline) to all time points (Day 29 [28 days after the first dose], Day 57 [28 days after the second dose], and Day 181 [six months after the first dose]).|At Day 29, Day 57 and Day 181|The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29, Day 57 and Day 181.|||Percentage of subjects||95% Confidence Interval|Number
2589052|NCT02298179|Secondary|Geometric Mean Titers (GMTs) of the Serum Total Binding Antibody to Each of the RSV Proteins F, G and N|Immunogenicity was measured in terms of the geometric mean titers (GMTs) of the serum total binding antibody to each of the RSV proteins F, G and N at Day 1 (baseline), Day 29 (28 days after the first dose), Day 57 (28 days after the second dose) and Day 181 (six months after the first dose).|At Day 1, Day 29, Day 57 and Day 181|The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29, Day 57 and Day 181.|||Titers||95% Confidence Interval|Geometric Mean
2589053|NCT02298179|Secondary|Percentage of Subjects With Serum Anti-RSV NAb Titers Greater Than the 3rd Quartile of Serum Anti-RSV NAb Titers at Day 1|Immunogenicity was measured in terms of the percentage of subjects at Day 29 (28 days after the first dose), Day 57 (28 days after the second dose) and Day 181 (six months after the first dose) with serum anti-RSV NAb titers greater than the 3rd quartile of serum anti-RSV NAb titers at Day 1 (baseline).|At Day 29, Day 57 and Day 181|The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29, Day 57 and Day 181.|||Percentage of subjects||95% Confidence Interval|Number
2589742|NCT02289989|Secondary|Rate Skin Tolerance of Topical Agents|The patient or caregiver rated how well the patient tolerated the product after applying it on day 7 and 14. The scale was excellent, good, moderate and poor.|On day 7 and 14||||participants|||Number
2589054|NCT02298179|Secondary|Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titer|Immunogenicity was measured in terms of percentage of subjects with a ≥ 4-fold increase in serum anti-RSV NAb titers from Day 1 to Day 29 (28 days after the first dose) and from Day 1 to Day 181 (six months after the first dose).|At Day 29 and at Day 181|The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29 and Day 181.|||Percentage of subjects||95% Confidence Interval|Number
2589055|NCT02298179|Secondary|Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers|Immunogenicity was measured in terms of GMTs of the serum anti-RSV neutralizing antibody (NAb) titers at Day 1, Day 29 (28 days after the first dose) and Day 181 (six months after the first dose).|At Day 1, Day 29 and Day 181|The analysis was based on the PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 1, Day 29 and at Day 181.|||Titers||95% Confidence Interval|Geometric Mean
2589056|NCT02298179|Primary|Number of Subjects With Serious Adverse Events (SAEs) and Other Significant AE(s)|"SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, congenital anomaly or birth defect. Any SAE = occurrence of the SAE regardless of intensity grade. Possibly or probably related SAE = SAE assessed by the investigator as possibly or probably related to the study vaccination.~Other significant AE(s) assessed include unsolicited medically attended AEs, unsolicited AEs leading to study withdrawal, new onset of chronic diseases (NOCDs) and adverse events of special interest (AESIs). Medically attended AE = an adverse event that leads to an unscheduled visit to a healthcare practitioner. NOCD = an adverse event that represents a new diagnosis of a chronic medical condition that was not present or suspected in a subject prior to study enrollment."|From study start (Day 1) until study completion (Day 394)|The analysis was based on the Unsolicited Safety Set, which included all subjects in the Exposed population with unsolicited AE data collected from study start (Day 1) until study completion (Day 394).|||Participants|||Count of Participants
2589057|NCT02298179|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|"An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.~Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination."|From Day 1 to Day 28 after each vaccination|The analysis was based on the Unsolicited Safety Set, which included all subjects in the Exposed population with unsolicited AE data collected after each vaccination.|||Participants|||Count of Participants
2589058|NCT02298179|Primary|Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity|Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.|From Day 1 (6 hours) to Day 7 after each vaccination|The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.|||Participants|||Count of Participants
2589059|NCT02298179|Primary|Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity|Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.|From Day 4 through Day 7 after each vaccination|The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.|||Participants|||Count of Participants
2589060|NCT02298179|Primary|Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity|Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.|From Day 1 (6 hours) through Day 3 after each vaccination|The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.|||Participants|||Count of Participants
2589061|NCT02298179|Primary|Number of Subjects With Any Solicited Systemic Symptoms and Other Indicators of Reactogenicity|Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.|Within 30 minutes after each vaccination|The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.|||Participants|||Count of Participants
2589062|NCT02298179|Primary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.|From Day 1 (6 hours) to Day 7 after each vaccination|The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.|||Participants|||Count of Participants
2589063|NCT02298179|Primary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.|From Day 4 through Day 7 after each vaccination|The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.|||Participants|||Count of Participants
2589064|NCT02298179|Primary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.|From Day 1 (6 hour) through Day 3 after each vaccination|The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.|||Participants|||Count of Participants
2589065|NCT02298179|Primary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.|Within 30 minutes after each vaccination|The analysis was based on the Solicited Safety set, which included all subjects in the Exposed population who provided post-vaccination reactogenicity data after each vaccination.|||Participants|||Count of Participants
2589066|NCT02298179|Primary|Percentage of Subjects With a ≥ 4-fold Increase in Serum Anti-RSV NAb Titers|Immunogenicity was measured in terms of percentage of subjects with a ≥ 4-fold increase in serum anti-RSV NAb titers, from Day 1 (baseline) to Day 57 (28 days after the second dose).|At Day 57|The analysis was based on PPS, which included all subjects in the FAS Immunogenicity population who were not excluded due to reasons defined prior to unblinding or analysis and and for whom immunogenicity results collected from Day 1 (baseline) up to Day 57 were available at Day 1 and Day 57.|||Percentage of subjects||95% Confidence Interval|Number
2589067|NCT02298179|Primary|Geometric Mean Titers (GMTs) of the Serum Anti-RSV Neutralizing Antibody (NAb) Titers|Immunogenicity was measured in terms of the Geometric mean titers (GMTs) of the serum anti-RSV neutralizing antibody (NAb) titers at Day 57 (28 days after the second dose).|At Day 57|The analysis was based on the Per-Protocol Set (PPS), which included all subjects in the Full Analysis Set (FAS) Immunogenicity population who were not excluded due to the reasons defined prior to unblinding or analysis and for whom immunogenicity data were available at Day 57.|||Titers||95% Confidence Interval|Geometric Mean
2589068|NCT02297841|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||24, 48, and 72 hours after patch application||||participants|||Number
2589069|NCT02297815|Secondary|Sleep Disturbance|"The PedsQL questionnaire includes one or two questions, depending on age, about sleep. For children <24 months, parents are asked the frequency (never, almost never, sometimes, often, almost always) their child has (1) difficulty falling asleep and (2) difficulty sleeping through the night. For children ≥2 years, parents are asked the frequency their child has trouble sleeping. We categorized children as either without sleep disturbance (Never for each sleep question) or with sleep disturbance. Outcome measure shows the number of participants with sleep disturbance."|Days 5-10 Interview|41 children missing race and ethnicity excluded; 1 child did not complete PedsQL|||Participants|||Count of Participants
2589070|NCT02297815|Secondary|Symptoms Present on Day 3|During 5-10 day interview, parents were asked about symptoms related to child's illness (otitis media: fever, ear pain, decreased appetite; sinusitis: fever, face/head pain, decreased appetite; pharyngitis: throat pain, fever, decreased appetite). Parent was asked if symptoms was present at diagnosis. If yes, had the symptom resolved. If yes, when. We assessed whether symptoms present at day 3 after diagnosis.|3 days after ARTI diagnosis|Among subjects who reported having at least one symptom at the time of diagnosis; 41 children missing race and ethnicity were excluded|||Participants|||Count of Participants
2589071|NCT02297815|Secondary|Experience Side Effects|Child experienced a side effect including: rash, diarrhea or upset stomach/vomiting|14-20 days after ARTI diagnosis|Question was asked in the 14-20 interview so some subjects were lost to follow-up; 41 children missing race and ethnicity were excluded|||Participants|||Count of Participants
2589072|NCT02297815|Secondary|Required Additional Childcare|Among children who attend school or daycare, parent or another caretaker had to miss work or an obligation due to child's illness OR additional childcare had to be sought for the child.|5-10 days after ARTI diagnosis|Among children who attend school or daycare; 41 children missing race and ethnicity were excluded|||Participants|||Count of Participants
2589073|NCT02297815|Secondary|Missed School or Daycare From Illness|Among children who attend school or daycare, child had to miss school or day care due to illness|5-10 days after ARTI diagnosis|Among children who attend school or daycare; 41 children missing race and ethnicity were excluded|||Participants|||Count of Participants
2589074|NCT02297815|Primary|Health Related Quality of Life Score|The health related quality of life score was obtained using the PedsQL(TM) (Mapi Research Trust, Lyon, France. www.pedsql.org) Parent-Proxy Report Generic Core Scales and Parent Report Infant Scales administered during the 5-10 day interview. Briefly, the PedsQL(TM) is a 23-item questionnaire assessing developmentally appropriate metrics (questions vary by age group: 1-12 months, 13-24 months, 2-4 years, 5-7 years, 8-12 years) related to core dimensions of health and role functioning. Our primary outcome was the Total Scale Score, which is a summary score of physical, emotional, social, and school functioning. The score range is zero to 100 and higher scores indicate a better health-related quality of life.|5-10 days after ARTI diagnosis|1 subject did not respond to enough of the questions to obtain a score; 41 children missing race and ethnicity were excluded|||scores on a scale||Standard Deviation|Geometric Mean
2589075|NCT02297516|Secondary|Injected Volume of Study Products at Initial Single Treatment|Evaluation of Azzalure/Dysport (Group A)/Filler (Group B) volume injected at initial single treatment (baseline).|Baseline||||Speywood Units/mL||Standard Deviation|Mean
2589076|NCT02297516|Secondary|Percentage of Subjects Improved in Wrinkle Severity Score|"The wrinkle severity of the Azzalure/Dysport treated glabellar lines at maximum frown was evaluated by the Investigator.~A validated 5-graded photonumeric grading scale was used, where each severity grade was illustrated by a set of photographs.~0 = No glabella lines~= Mild glabella lines~= Moderate glabella lines~= Severe glabella lines~= Very severe glabella lines Improvement means going from higher score to lower score."|7 and 13 months|Number of analyzed subjects was reduced over time due to drop-out of study subjects.|||percentage of participants||95% Confidence Interval|Number
2589238|NCT02294786|Secondary|Proportion of Subjects Reporting Stopping Completely or Missing Doses of Anti-cancer Tablets Due to Diarrhoea as Recorded in the DMD|The proportion of subjects reducing or completely stopping the number of anti-cancer tablets to help with diarrhoea are summarised|Up to 24 weeks|ITT|||Participants|||Count of Participants
2589077|NCT02297516|Secondary|Number of Participants for Which the Investigator is Satisfied With the Outcome|"The Investigators answered the question How satisfied are you with the overall facial aesthetic outcome for the subject? with Very/somewhat satisfied, Neither/nor, or Very/somewhat dissatisfied. Satisfied criteria met for those subjects that the Investigator answered Very/somewhat satisfied."|7 and 13 months|Number of analyzed subjects varied over time due to drop-out of study subjects.|||Participants|||Count of Participants
2589078|NCT02297516|Secondary|Number of Participants Satisfied With Facial Appearance|"The subjects were asked to answer the question How satisfied are you today with the appearance of your face? with Very/somewhat satisfied, Neither/nor, or Very/somewhat dissatisfied. Satisfied criteria is fulfilled for those subjects that answered Very/somewhat satisfied."|7 and 13 months|Number of analyzed subjects varied over time due to drop-outs from study.|||Participants|||Count of Participants
2589079|NCT02297516|Secondary|Number of Subjects Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator|"The 5-graded GAIS was used to assess the facial aesthetic improvement from Baseline by responding to the question: How would you describe the subject's global facial aesthetic appearance compared to the photographs taken before treatment at Baseline?.~The following rating was used: Very much improved, Much improved, Somewhat improved, No change, or Worse.~Criteria for improvement met for those subjects that were assessed as Very much improved, Much improved, or Somewhat improved.~GAIS score was assessed by three blinded evaluators at Months 1, 7, and 13 (1 month after single treatment, 1 month after first combined treatment, and 1 month after second combined treatment). The blinded evaluators performed the evaluations retrospectively using 2D-photographs from each follow-up visit and from Baseline (Visit 1)."|1, 7, and 13 months|"Number of analyzed subjects varied over time due to drop-outs from study. Data not presented Per Arm, since statistical analysis was only performed on both groups combined after the combination treatments (since the groups receive the exact same treatment during the combination treatment)."|||% participants||95% Confidence Interval|Number
2589080|NCT02297516|Secondary|Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance|"Subjects showing superior Global facial aesthetic appearance at 1, 7 and 13 months.~Assessment of global facial aesthetic appearance was based on blinded evaluations of subject's youthful appearance (e.g. lack of facial volume loss, lack of static wrinkles and fine lines, good skin quality, and satisfactory result after aesthetic treatment).~The blinded evaluators retrospectively reviewed photographs from visit for each subject and answered the following question: At which set of photographs does the subject show superior global facial aesthetic appearance?."|1, 7 and 13 months|Six subjects that were assessed differently by all three evaluators were excluded from the analysis. In addition, one subject was excluded from the analysis due to wrong photographs at Month 1.|||percentage of subjects|||Number
2589081|NCT02297516|Primary|Percentage of Subjects With Improvement in Global Facial Aesthetic Appearance|"Percentage of subjects showing superior global facial aesthetic appearance at month 7 compared to month 1.~Assessment of global facial aesthetic appearance was based on blinded evaluations of subject's youthful appearance (e.g. lack of facial volume loss, lack of static wrinkles and fine lines, good skin quality, and satisfactory result after aesthetic treatment).~The blinded evaluators retrospectively reviewed photographs from visit for each subject and answered the following question: At which set of photographs does the subject show superior global facial aesthetic appearance?."|7 months|One subject in Group A was excluded from the analysis due to the wrong photographs being used in the evaluation.|||percentage of subjects|||Number
2589082|NCT02297503|Secondary|Adverse Event Reporting|To evaluate safety throughout the study period|0-18 months|Safety population|||Treatment related AEs|||Number
2589083|NCT02297503|Secondary|Injected Filler Volume|To evaluate the filler volume injected at initial single treatment and at following repeated combined treatment|Initial single treatment (baseline), first combined treatment (Month 6), and second combined treatment (Month 12)|"For the initial single treatment, only the Filler alone as initial treatment participants received filler. At the two combination treatments, all subjects received filler. Data from the Filler alone as initial treatment participants are presented for the single treatment while data for all subjects are presented for the combination treatments."|||mL||Standard Deviation|Mean
2589084|NCT02297503|Secondary|Change in Perceived Age of Subjects|"To evaluate First impression and perceived age of subjects by evaluation of photos.~Change between timepoints are reported. A negative value indicates that the participant is assessed to be younger at the specified visit compared to the assessment made at 1 month after single treatment."|1 and 7 months, and 1 and 13 months|Five participants excluded from analysis due to incorrectly taken photographs.|||years||Standard Deviation|Mean
2589085|NCT02297503|Secondary|Number of Participants Who Had Improvement in Wrinkle Severity Score of Treated Glabellar Lines (Validated Photo Scales)|The wrinkle severity of the glabellar lines at maximum frown was evaluated by the investigator at baseline before first treatment and at follow-up visits. Validated photonumeric grading scales were used where each severity grade is illustrated by a set of photographs. The investigator performed the assessment live or by using 2D photographs from the present visit, together with the respective photo guide: 0 No glabella lines, 1 Mild glabella lines, 2 Moderate glabella lines, 3 Severe glabella lines, 4 Very severe glabella lines. Improved criteria is thus fulfilled for subjects receiving a lower score compared to baseline.|Month 7 and Month 13||||participants|||Number
2589086|NCT02297503|Secondary|Number of Subjects for Which the Investigator is Satisfied With Overall Facial Aesthetic Outcome|"The Investigator answered the question How satisfied are you with the overall facial aesthetic outcome for the subject? with Very/somewhat satisfied, Neither/nor, or Very/somewhat dissatisfied. Satisfied criteria is met for those subjects that the Investigator answered Very/somewhat satisfied."|Month 7 and Month 13||||participants|||Number
2589087|NCT02297503|Secondary|Number of Subjects Satisfied With Overall Facial Appearance (Questionnaire)|"Subjects answered the question How satisfied are you today with the appearance of your face? with Very/somewhat satisfied, Neither/nor, or Very/somewhat dissatisfied. Number of subjects satisfied are those that answered Very/somewhat satisfied."|Month 7 and Month 13||||participants|||Number
2589124|NCT02296775|Secondary|Volume of Distribution (Vz)|Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI), 6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) , 168 (post-EOI), 336 hours (post-EOI), 4 weeks, 6 weeks, 8 weeks, 10 weeks, 14 weeks, 18 weeks, and 22 weeks relative to infusion.|24 weeks|Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=230|||L||Geometric Coefficient of Variation|Geometric Mean
2589088|NCT02297503|Secondary|Number of Participants Improved on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Blinded Evaluator|"The 5-graded GAIS is used to assess the facial aesthetic improvement from baseline by responding to the question: How would you describe the subject's global facial aesthetic appearance, compared to the photographs taken before treatment at baseline? The scale grades are Very much improved, Much improved, Somewhat improved, No change, Worse. Improved subjects are those graded as Very much improved, Much improved, and Somewhat improved."|Month 1, Month 7, and Month 13|"Number of analyzed subjects decreased over time due to drop-out of study subjects.~Data not presented Per Arm, since statistical analysis was only performed on both groups combined after the combination treatments (since the groups receive the exact same treatment during the combination treatment)."|||participants|||Number
2589089|NCT02297503|Secondary|Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 1, 7 and 13 Months (Review of Photographs)|"To evaluate Global facial aesthetic appearance at 1, 7 and 13 months, blinded evaluator review of photographs from the respective visits."|1, 7 and 13 months|Incorrectly taken photographs for six participants were excluded from analysis. Additionally two participants excluded because they were assessed different by all three evaluators.|||Participants|||Count of Participants
2589090|NCT02297503|Primary|Number of Subjects With Improvement in Global Facial Aesthetic Appearance at 7 Months (Review of Photographs)|"To evaluate Global facial aesthetic appearance at 7 months compared to at 1 month, blinded evaluator review of photographs."|7 months||||Participants|||Count of Participants
2589091|NCT02297412|Primary|Area Under the Curve (AUC) Per Assessment (aAUCpa) of Fatigue (Item 10 on the Acute Pain Syndrome Summary Questionnaire)|"Area Under the Curve (AUC) Per Assessment (aAUCpa) of Fatigue (Item 10 on the Acute Pain Syndrome Summary Questionnaire); Over the past week, did you experience fatigue?) over 12 weeks. Scores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment."|Baseline to up to 12 weeks|Patients who completed the Acute Pain Syndrome Summary Questionnaire over 12 weeks are included in this analysis.|||scores on a scale||Full Range|Median
2589092|NCT02297412|Primary|Area Under the Curve (AUC) of EORTC CIPN20 Sensory Neuropathy Subscale|Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neurophathy Module (EORTC QLQ-CIPN20) Sensory Neuropathy Subscale. The EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for the subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to week-12 are averaged to yield the aAUCpa per patient per subcale.|Up to course 12|Patients who completed the EORTC Chemotherapy-Induced Peripheral Neurophathy Module Sensory Neuropathy Subscale items over 12 weeks were included in this analysis.|||scores on a scale||Full Range|Median
2589093|NCT02297412|Primary|Area Under the Curve (AUC) Per Assessment (aAUCpa) of Average Pain (Item 3 on the Daily Post-Paclitaxel Questionnaire)|"Average Area Under the Curve (AUC) per assessment (aAUCpa) of average pain (item 3 on the Daily Post-Paclitaxel Questionnaire; Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.) over 12 weeks. Scores are reported on a 0-100 scale, where 100=better outcome quality of life (QOL). The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the week-12 assessment."|Up to 12 weeks|Patients who completed the Daily Post-Paclitaxel Questionnaire item 3 over 12 weeks were included in this analysis.|||scores on a scale||Full Range|Median
2589094|NCT02297308|Secondary|Bleeding Complications at the Access Site|VARC-2 defined vascular access site bleeding complications i.e. minor, major or life threatening bleeding|within 30 days of TAVI procedure||||participants|||Number
2589095|NCT02297308|Primary|Vascular Access Site Complications|Rate of VARC-2 defined vascular complications within 30 days of TAVI.|withn 30 days of TAVI procedure||||participants|||Number
2589096|NCT02297230|Secondary|To Acquire Descriptive Information on Patient Adherence to Therapy and on Quality of Life During Treatment.|Data were not collected as PI left institution prior to enrollment completion. Planned Statistical analysis was not performed for this secondary outcome measure.|12/2014 (up to 12 years)|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2589097|NCT02297230|Secondary|To Store Core Biopsies of the Original Tumor Before and After Treatment (From the Surgical Specimen) for Future Molecular Biology Studies in LABC.|No data displayed because Outcome Measure has zero total participants analyzed.|12/2014 (up to 12 years)|Data were not collected as PI left institution prior to enrollment completion. PI terminated protocol.||||||
2589098|NCT02297230|Secondary|To Assess the Pathological Response Rate and Compare it to That Achieved in Our Previous Phase I-II Trials of Concurrent Chemo-radiation.|No data displayed because Outcome Measure has zero total participants analyzed.|12/2014 (up to 12 years)|Planned Statistical analysis was not performed for this secondary outcome measure. Study Terminated prematurely; PI left institution;||||||
2589099|NCT02297230|Primary|Feasibility & Efficacy of Chemo-radiation While Targeting Treatment, Based on: Original Tumor Characteristics; to be Followed by [Need for] Conventional Post-operative Chemotherapy||12/2014 (up to 12 years)|Data were not collected as PI left institution prior to enrollment completion. PI terminated protocol.||||||
2589100|NCT02297100|Other Pre-specified|Secondary Outcomes Will be Assessing Change in Patient Performance in Post Void Residuals.||30 days and 90 days post treatment|Data was not collected on one participant in the experimental group at 30 and 90 days post treatment. Data was not collected on two individuals at 30 days post treatment in the control group.|||mL||Standard Deviation|Mean
2589101|NCT02297100|Secondary|Change in Patient Performance in Uroflowmetry.|Uroflowmetry is a test that measures the volume of urine released from the body, the speed with which it is released, and how long the release takes.|30 days and 90 days post treatment|No data was collected for two participants in the experimental group and one participant in the control group at 30 days. No data was collected for one participant in the experimental group at 90 days.|||ml/s||Standard Deviation|Mean
2590953|NCT02277665|Primary|Cannabis Abstinence|number of participants who achieved at least one week of documented cannabis abstinence during treatment|Weeks 1-12||||Participants|||Count of Participants
2589102|NCT02297100|Primary|The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the Pelvic Pain and Urinary Urgency Frequency (PUF) Questionnaire|The PUF questionnaire evaluates symptoms of pain and how much they bother the patient. Two score are given and added together to produce a total score. The score range for symptoms is 0-28 and the range for bother is 0-16. Higher scores denotes worse outcomes.|30 and 90 days post-treatment|One participant from the experimental group was lost to follow-up. Data was not collected at 30 days for bother and symptom for one participant in the control group.|||units on a scale||Standard Deviation|Mean
2589103|NCT02297100|Primary|The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the O'Leary-Sant Symptom and Problem Indexes.|The O'Leary-Sant is one questionnaire that assesses the severity of symptoms and the how much of a problem the symptoms cause for the patient and it provides two scores. The scores ranges for the symptoms is 0-20 and for how bothersome the symptoms are, the score range is 0-16. Higher scores for both denotes worse outcomes.|30 and 90 days post treatment|One participant was lost to follow-up in the experimental group and no data was collected at 30 days on one participant in the control group.|||units on a scale||Standard Deviation|Mean
2589104|NCT02296931|Primary|Error in the Total Volume Dispensed and Flow Rate|This is the error value for the volume dispensed by the AutoSyp device relative to the volume intended to be dispensed. Preeclamptic subjects received an initial loading dose followed by a maintenance dose. The loading dose had a flow rate of 60 mL/hr and delivered 20 mL in a single 20 mL syringe. The maintenance dose was 5 mL/hr and dispensed 120 mL total through two 60 mL syringes. The healthy subjects experienced variable flow rates and dispensed volumes, so they do not have the same variables as the pre-eclamptic pregnant women in the outcome data tables below. Because of these differences in dosing the two arms of the study, healthy women and preeclamptic women have different outcome measure data.|1 day visit||||percentage of error||Full Range|Mean
2589105|NCT02296892|Secondary|Time to Ready for Discharge|Time from the last dose of study drug or rescue sedative and from the end of bronchoscopy until discharge (defined as the ability to walk unassisted)|After the last dose of study drug AND after the end of the bronchoscopy, until discharge|Patients who do not reach the endpoint are censored at last MOAAS|||minutes||95% Confidence Interval|Median
2589106|NCT02296892|Secondary|Time to Fully Alert|"The time to fully alert defined as time to first of 3 consecutive Modified Observer's Assessment of Alertness and Sedation (MOAA/S) scores after the end of the bronchoscopy procedure (bronchoscope out).~MOAA/S scores: 5 = Responds readily to name spoken in normal tone [alert], 4 =Lethargic response to name spoken in normal tone, 3 = Responds only after name is called loudly and/or repeatedly, 2 = Responds only after mild prodding or shaking, 1 = Responds only after painful trapezius squeeze, 0 = Does not respond to painful trapezius squeeze.~MOAA/S scores were assessed by the investigators."|From the last dose of study drug or rescue sedative AND from end of bronchoscopy until the patient has recovered to fully alert|Patients who do not reach the endpoint are censored at last MOAAS|||minutes||95% Confidence Interval|Median
2589107|NCT02296892|Secondary|Time to Start of Procedure|The time from the first dose of study drug until bronchoscope insertion on Day 1|From first dose of study drug until insertion of the bronchoscope|All patients who were randomized and were analyzed as randomized.|||minutes||95% Confidence Interval|Median
2589108|NCT02296892|Primary|Number of Participants With a Successful Procedure|Success of Procedure measured by completion of bronchoscopy, no requirement for an alternative rescue sedative medication and no requirement for more than 5 doses of study medication within any 15 minute period in the blinded arms (remimazolam/placebo) or no requirement for more than 3 doses within any 12 minute window in the open-label midazolam arm.|From first dose of study drug to removal of bronchoscope (average time not known)|All patients who were randomized and were analyzed as randomized.|||Participants|||Count of Participants
2589109|NCT02296840|Secondary|Number of Participants With Post-operative Bleeding|The occurrence of post-operative bleeding at the surgical site for each participant will be assessed by review of the participant's study records and clinical records and by questioning the caregiver in follow-up. If postoperative bleeding has occurred, details of the episode of bleeding will also be obtained (requirement for surgical intervention, observation at home, or observation at the hospital).|2 weeks after surgery|All study participants are included in this analysis.|||Participants|||Count of Participants
2589110|NCT02296840|Primary|Faces Pain Score|Using the Faces Pain Scale, the pediatric patient will indicate his/her pain level at scheduled intervals (7 times per day) for 14 days post-surgery.The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain. For this analysis, participant pain scores were summed and the mean per group was calculated. Total summed scores could range from 0 to 980.|2 weeks after surgery|Children who returned the completed the survey at two weeks post-surgery.|||units on a scale||Standard Deviation|Mean
2589111|NCT02296775|Secondary|Change From Baseline in HAQ-DI at Week 24.|"The health assessment questionnaire disability index (HAQ-DI) was assessed at Week 24. The disability assessment component of the HAQ, the HAQ-DI, assessed a patient's level of functional ability and included questions about fine movements of the upper extremities, locomotor activities of the lower extremities, and activities that involved both upper and lower extremities. There were 20 questions in 8 categories of functioning which represented a comprehensive set of functional activities-dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The stem of each item asked over the past week Were you able to perform a particular task. The patient's responses were made on a scale from 0 (no disability) to 3 (completely disabled). Each category contained at least 2 specific component questions.~Physical function was measured using the HAQ-DI Scores, which range from 0-3, with lower scores reflecting better physical function and thus, less disability."|24 weeks||||score on a scale||Standard Deviation|Geometric Mean
2589112|NCT02296775|Secondary|Percentage of Patients With ACR70 Response at Week 24|Percentage of the patients with at least 70% improvement in counts of tender, swollen joints and in 3 of the following: patient's assessment of pain, patient's global assessment of disease activity, patient's assessment of physical function, the physician's global assessment of disease activity, and acute phase reactant. Adjusted Response rates for the treatment arms using the logistic regression analysis including treatment, gender and region as fixed effects and patients as random effect in the model.|24 weeks||||Percentage of participants|||Number
2589113|NCT02296775|Secondary|Percentage of Patients With ACR50 at Week 24|Percentage of the patients with at least 50% improvement in counts of tender, swollen joints and in 3 of the following: patient's assessment of pain, patient's global assessment of disease activity, patient's assessment of physical function, the physician's global assessment of disease activity, and acute phase reactant. Adjusted Response rates for the treatment arms using the logistic regression analysis including treatment, gender and region as fixed effects and patients as random effect in the model.|24 weeks||||Percentage of participants|||Number
2589114|NCT02296775|Secondary|Percentage of Patients With ACR20 at Week 24|Percentage of the patients with at least 20% improvement in counts of tender, swollen joints and in 3 of the following: patient's assessment of pain, patient's global assessment of disease activity, patient's assessment of physical function, the physician's global assessment of disease activity, and acute phase reactant. Adjusted response rates for the treatment arms using the logistic regression analysis including treatment, gender and region as fixed effects and patients as random effect in the model.|24 weeks||||Percentage of participants|||Number
2589115|NCT02296775|Secondary|Percentage of Patients With Peripheral B-cell Counts Depletion at Week 24.|Analysis of the PD parameter peripheral B-Cell count was performed by evaluating the 95% CI for the difference between treatment arms in the percentage of patients with B-cell depletion at 48 hours after dose 1, Week 16, and at Week 24. Percentage of patients with B-cell repletion at each evaluation time is also reported and descriptively compared.|24 weeks||||percentage of participants|||Number
2589116|NCT02296775|Secondary|Percentage of Patients With Peripheral B-cell Counts Depletion at Week 16.|Analysis of the PD parameter peripheral B-Cell count was performed by evaluating the 95% CI for the difference between treatment arms in the percentage of patients with B-cell depletion at 48 hours after dose 1, Week 16, and at Week 24. Percentage of patients with B-cell repletion at each evaluation time is also reported and descriptively compared.|16 weeks||||percentage of participants|||Number
2589117|NCT02296775|Secondary|Percentage of Patients With B-cell Counts 20% Below the Lower Limit of Normal|The time to depletion and repletion of peripheral blood cell counts (determined by CD19+ cell counts) as well as the B-cell counts at selected time points (taking into consideration the patient baseline count) were used to assess the PD of the study drugs.|48 hours||||Percentage of participants|||Number
2589118|NCT02296775|Secondary|Mean Change in Disease Activity Score- C Reactive Protein (DAS28-CRP) From Baseline Per Unit Time at Week 16.|In clinical studies, Disease Activity Score (DAS) is used to assess improvement in disease activity in RA patients over time. The assessment involved an examination of 28 joints for swelling, tenderness, blood C-reactive protein (CRP), and a one on one consultation between the patient and healthcare professional. The results were combined to produce a score which indicated how active the RA was at that particular time. The disease activity is interpreted as low (DAS <2.6), mild (2.6 to <3.2), moderate (3.2 to <5.1), and severe with DAS > 5.1. A DAS score between 0 and 2.6 corresponds to remission. The analysis of DAS28-CRP was based on a generalized estimating equation model in RA patients with DAS28 score > 3.2. The mean change was calculated from two time points (Value at 16 weeks minus baseline value).|Baseline and 16 weeks||||units on a scale||Standard Deviation|Mean
2589119|NCT02296775|Secondary|Mean Change in DAS28-CRP From Baseline Per Unit Time at Week 12.|In clinical studies, Disease Activity Score (DAS) is used to assess improvement in disease activity in RA patients over time. The assessment involved an examination of 28 joints for swelling, tenderness, blood C-reactive protein (CRP), and a one on one consultation between the patient and healthcare professional. The results were combined to produce a score which indicated how active the RA was at that particular time. The disease activity is interpreted as low (DAS <2.6), mild (2.6 to <3.2), moderate (3.2 to <5.1), and severe with DAS > 5.1. A DAS score between 0 and 2.6 corresponds to remission. The analysis of DAS28-CRP was based on a generalized estimating equation model in RA patients with DAS28 score > 3.2. The mean change was calculated from two time points (Value at 12 weeks minus baseline value).|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2589120|NCT02296775|Secondary|Mean Change in DAS28-CRP From Baseline Per Unit Time at 8 Weeks.|In clinical studies, Disease Activity Score (DAS) is used to assess improvement in disease activity in RA patients over time. The assessment involved an examination of 28 joints for swelling, tenderness, blood C-reactive protein (CRP), and a one on one consultation between the patient and healthcare professional. The results were combined to produce a score which indicated how active the RA was at that particular time. The disease activity is interpreted as low (DAS <2.6), mild (2.6 to <3.2), moderate (3.2 to <5.1), and severe with DAS > 5.1. A DAS score between 0 and 2.6 corresponds to remission. The analysis of DAS28-CRP was based on a generalized estimating equation model in RA patients with DAS28 score > 3.2. The mean change was calculated from two time points (Value at 8 weeks minus baseline value).|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2589121|NCT02296775|Secondary|Mean Change in Disease Activity Score-C Reactive Protein (DAS28-CRP) From Baseline Per Unit Time at Weeks 4|In clinical studies, Disease Activity Score (DAS) is used to assess improvement in disease activity in RA patients over time. The assessment involved an examination of 28 joints for swelling, tenderness, blood C-reactive protein (CRP), and a one on one consultation between the patient and healthcare professional. The results were combined to produce a score which indicated how active the RA was at that particular time. The disease activity is interpreted as low (DAS <2.6), mild (2.6 to <3.2), moderate (3.2 to <5.1), and severe with DAS > 5.1. A DAS score between 0 and 2.6 corresponds to remission. The analysis of DAS28-CRP was based on a generalized estimating equation model in RA patients with DAS28 score > 3.2. The mean change was calculated from two time points (Value at 4 weeks minus baseline value).|Baseline and 4 weeks||||units on a scale||Standard Deviation|Mean
2589122|NCT02296775|Secondary|Terminal Half-life (t1/2)|Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI), 6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) , 168 (post-EOI), 336 hours (post-EOI), 4 weeks, 6 weeks, 8 weeks, 10 weeks, 14 weeks, 18 weeks, and 22 weeks relative to infusion.|24 weeks|Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=230|||h||Geometric Coefficient of Variation|Geometric Mean
2589123|NCT02296775|Secondary|Systemic Clearance (CL)|Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI), 6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) , 168 (post-EOI), 336 hours (post-EOI), 4 weeks, 6 weeks, 8 weeks, 10 weeks, 14 weeks, 18 weeks, and 22 weeks relative to infusion.|24 weeks|Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=230|||L/day||Geometric Coefficient of Variation|Geometric Mean
2589127|NCT02296775|Secondary|Maximum Plasma Concentration (Cmax) After Second Dose|Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI),6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) , 168 (post-EOI), and 336 hours post EOI.|2 weeks|Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=224|||ug/ml||Geometric Coefficient of Variation|Geometric Mean
2589128|NCT02296775|Secondary|Maximum Plasma Concentration (Cmax) After First Dose|Plasma concentration was measured at 0, 3, 4.25 (End of infusion (EOI)) ,1 (post- EOI), 6 (post-EOI) , 24 (post-EOI) , 48 (post-EOI) ,and 168 hours (post-EOI).|2 weeks|Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=218.|||ug/ml||Geometric Coefficient of Variation|Geometric Mean
2589129|NCT02296775|Primary|Area Under Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) (Second Dose).|PK samples were collected pre-infusion; 3 hours post infusion; EOI; and at 1, 6, 24, 48, 168 hours post End of Infusion. A PK sample at 336 hours post EOI were also to be collected after the second dose|16 weeks|Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=220|||ug*h/ml||Geometric Coefficient of Variation|Geometric Mean
2589130|NCT02296775|Primary|AUC0-∞ Over the Entire Course of Therapy (2 Doses) From Day 1 Through Week 16.|PK samples were collected pre-infusion; 3 hours post infusion; EOI; and at 1, 6, 24, 48, 168 hours post End of Infusion. A PK sample at 336 hours post EOI were also to be collected after the second dose.|16 weeks|Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=212|||ug*h/ml||Geometric Coefficient of Variation|Geometric Mean
2589131|NCT02296775|Primary|Area Under the Concentration-Time Curve From Time 0 to 336 Hours (AUC0-336) Post First Dose|PK samples were collected pre-infusion; 3 hours post infusion; EOI; and at 1, 6, 24, 48, 168 hours post End of Infusion. A PK sample at 336 hours post EOI were also to be collected after the second dose.|2 weeks|Population numbers exclude ADA positive individuals and the total number analyzed is updated to n=218|||ug*h/ml||Geometric Coefficient of Variation|Geometric Mean
2589132|NCT02296606|Primary|1. Explore the Interrater Reliability of Pupillary Assessments When Conducted in the Natural Setting by a Diverse Group of Practitioners|Two human assessors conducted and recorded the results of a clinical pupillary assessment on one patient within 5 minutes of one another. The researcher then conducted and recorded pupillary information on the same patient (within the same 5 minute window) using the NeurOptics Pupillometer.|9 months of pupillary assessments||||Kappa score|paired pupil assessments|95% Confidence Interval|Mean
2589133|NCT02296502|Primary|Sensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV Criteria|"Sensitivity and Specificity of DSM-5 Criteria for ASD Relative to DSM-IV Criteria~Sensitivity refers to the ability of the DSM-5 to correctly identify those with ASD, whereas specificity is the ability of the DSM-5 to correctly identify those without ASD."|day||||proportion of pts dx'd ASD w/DSM5|||Number
2589134|NCT02296502|Primary|Clinical Features of Concordant vs Discordant Groups|"Clinical Features of Concordant versus Discordant Groups. Full Scale IQ: Stanford-Binet IQ test.(score range 40-160; higher = greater intellectual abilties)~ABC = Aberrant Behavior Checklist, which includes:~Irritability subscale: score range 0-45, higher = more problems. Social Withdrawal subscale: score range 0-48, higher = more problems. Stereotypic Behavior subscale: score range 0-21, higher = more problems. Hyperactivity/Noncompliance subscale: score range 0-48, higher = more problems. Inappropriate Speech subscale: score range 0-12, higher = more problems.~CBCL = Child Behavior Checklist, which includes:~Externalizing Problems and Internalizing problems: T scores less than 60 are considered in the normal range, 60-63 represent borderline scores, and scores greater than 63 are in the clinical range"|One day||||units on a scale||Standard Deviation|Mean
2589135|NCT02296476|Secondary|Area Under the Concentration-time Curve of MK-8628 From Time 0 to Infinity (AUC 0-∞)|Blood samples were obtained at specified time points for the PK analysis of AUC 0-∞ of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry. The AUC 0-∞ was estimated indirectly using the dose and CL/F values. The AUC 0-∞ of MK-8628 after oral administration is presented.|Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours|All participants who received MK-8628 and had blood samples drawn for PK analyses.|||μg•hours/Liter||Standard Deviation|Mean
2589136|NCT02296476|Secondary|Observed Minimum Concentration (Cmin) of MK-8628|Blood samples were obtained at specified time points for the PK analysis of Cmin of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry. A single Cmin value for MK-8628 was estimated using dose and steady-state predose concentrations of MK-8628 on Days 29 and 57. The Cmin of MK-8628 after oral administration is presented.|Predose on Days 29 and 57|All participants who received MK-8628 and had predose blood samples drawn on Days 29 and 57 for steady state MK-8628 concentration. Participants in the 160 mg dose group were not analyzed for Cmin because they discontinued before Day 29.|||μg/Liter||Standard Deviation|Mean
2589137|NCT02296476|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/F) of MK-8628|Blood samples were obtained at specified time points for the PK analysis of Vz/F of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry and Vz/F was calculated using the nonlinear mixed-effects modelling software program Monolix version 4.3.2s. The Vz/F of MK-8628 after oral administration is presented.|Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours|All participants who received MK-8628 and had blood samples drawn for PK analyses.|||Liters||Standard Deviation|Mean
2589138|NCT02296476|Secondary|Apparent Total Body Clearance (Cl/F) of MK-8628|Blood samples were obtained at specified time points for the PK analysis of Cl/F of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry and Cl/F was calculated using the nonlinear mixed-effects modelling software program Monolix version 4.3.2s. The Cl/F of MK-8628 after oral administration is presented.|Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours|All participants who received MK-8628 and had blood samples drawn for PK analyses.|||Liters/hour||Standard Deviation|Mean
2589139|NCT02296476|Secondary|Apparent Terminal Half-Life (t1/2) of MK-8628|Blood samples were obtained at specified time points for the PK analysis of t1/2 of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry and t1/2 was calculated using the nonlinear mixed-effects modelling software program Monolix version 4.3.2s. The t1/2 of MK-8628 after oral administration is presented.|Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours|All participants who received MK-8628 and had blood samples drawn for PK analyses.|||hours||Standard Deviation|Mean
2589140|NCT02296476|Secondary|Time to Maximum Concentration (Tmax) of MK-8628|Blood samples were obtained at specified time points for the PK analysis of Tmax of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry and Tmax was calculated using the nonlinear mixed-effects modelling software program Monolix version 4.3.2s. The Tmax of MK-8628 after oral administration is presented.|Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours postdose|All participants who received MK-8628 and had blood samples drawn for PK analyses.|||hours||Standard Deviation|Mean
2589141|NCT02296476|Secondary|Observed Maximum Concentration (Cmax) of MK-8628|Blood samples were obtained at specified time points for the pharmacokinetic (PK) analysis of Cmax of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry and Cmax was calculated using the nonlinear mixed-effects modelling software program Monolix version 4.3.2s. The Cmax of MK-8628 after oral administration is presented.|Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours postdose|All participants who received MK-8628 and had blood samples drawn for PK analyses.|||μg/Liter||Standard Deviation|Mean
2589142|NCT02296476|Secondary|Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1|A DLT was defined as any of the following toxicities that were considered by the investigator to be related to MK-8628: Hematologic toxicity: Grade 4 hematologic toxicity or febrile neutropenia, Grade 3 neutropenia with infection, Grade 3 thrombocytopenia with bleeding or lasting >7 days; Non-hematologic toxicity: Grade 3 or 4 non-hematologic toxicity (regardless of duration) unless it was not optimally managed with supportive care, Grade 3 or 4 laboratory abnormality lasting >7 days, or intolerable Grade 2 non-hematologic toxicity resulting in study treatment discontinuation or delay >7 days with or without dose reduction.|Up to Cycle 1 (Up to 28 days)|All participants who received at least 21 days of the planned dose of study drug during the first 28-day cycle or experienced a DLT.|||Participants|||Count of Participants
2589143|NCT02296476|Secondary|Number of Participants Who Discontinued Study Treatment Due to an AE|The number of participants who discontinued study treatment due to an AE is presented.|Up to 6 Months|All participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2589144|NCT02296476|Secondary|Number of Participants Who Experienced at Least One Toxicity Grade 3-5 AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. The number of participants who experienced ≥1 Grade 3-5 AE per National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03 criteria is presented. Grade 3 was classified as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care; Grade 4 was classified as potentially life-threatening or disabling; and Grade 5 was an AE resulting in death.|Up to 6 Months|All participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2589145|NCT02296476|Secondary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. The number of participants who experienced at least one AE is presented.|Up to 6 Months|All participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2589146|NCT02296476|Secondary|Progression-free Survival|Progression-free survival was the time from the start of study treatment to the date of clinical or radiographic evidence of progressive disease according to RANO 2010 criteria or death. Progression, as assessed by RANO 2010, was defined as a ≥25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. PFS was measured as the number of participants who were alive and progression-free for up to 6 months.|Up to 6 Months|All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression.|||Participants|||Count of Participants
2589147|NCT02296476|Secondary|Overall Survival (OS)|OS was the time from the start of study treatment to the date of death. Participants were to be censored at their last contact if they were still alive at the cut-off date. OS was calculated for all participants who did not discontinue from the study due to disease progression.|Up to 6 Months|All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression. Since all participants discontinued the study due to disease progression, OS could not be calculated.||||||
2589148|NCT02296476|Secondary|Duration of Response (DOR)|DOR was the time from the first documented CR (complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks; no new lesions; no corticosteroids; and stable or improved clinically)or PR (≥50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; no new lesions; stable or reduced corticosteroid dose; and stable or improved clinically), as assessed by RANO 2010, until documentation of disease progression, or the date of the last tumor assessment (if there was no documented progression), or the last tumor assessment before the start of further antitumor therapy. DOR was calculated for all participants who experienced a CR or PR.|Up to 6 Months|All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression. Since no participants experienced a CR or PR, DOR could not be calculated.||||||
2589194|NCT02296112|Secondary|"Overall Response Rate in Low Affinity Group"|Per RECIST criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.|Up to 12 months|Patients on study with low activity|||proportion||95% Confidence Interval|Mean
2589149|NCT02296476|Secondary|Objective Response Rate (ORR)|ORR was defined as the number of participants in the analysis population who experienced a Complete Response (CR: complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks; no new lesions; no corticosteroids; and stable or improved clinically) or a Partial Response (PR: ≥50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; no new lesions; stable or reduced corticosteroid dose; and stable or improved clinically) and was assessed using RANO 2010.|Up to 6 Months|All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression.|||Participants|||Count of Participants
2589150|NCT02296476|Primary|Progression-free Survival (PFS) at 6 Months|Progression-free survival was the time from the start of study treatment to the date of clinical or radiographic evidence of progressive disease according to Response Assessment in Neuro-Oncology (RANO) 2010 criteria or death. Progression, as assessed by RANO 2010, was defined as a ≥25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. PFS at 6 months was measured as the percentage of participants who were alive and progression-free at Month 6. PFS at 6 months was calculated for all participants who were actively enrolled in the study at the 6-month time point.|Month 6|All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study magnetic resonance imaging (MRI). Since no participants reached the 6-month time point in the study, PFS at 6 months could not be calculated.||||||
2589151|NCT02296424|Secondary|Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 2|AEs, Deaths, other serious adverse events or discontinuations due to AE, Part II (Safety set)|During study parts I and II, estimated study duration was not more than 216 weeks (with an average duration of 108 weeks).|Safety Set|||number of participants|||Number
2589152|NCT02296424|Secondary|Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 1|AEs, Deaths, other serious adverse events or discontinuations due to AE, Part I (Safety set)|During study parts I and II. The estimated study duration is not more than 216 weeks (with an average expected duration of 108 weeks).|Safety Set|||number of participants|||Number
2589153|NCT02296424|Primary|Number of Participants in Clinical Remission on Canakinumab Who Are Able to Remain at an Initial Reduced Canakinumab Dose or Prolonged Canakinumab Dose Interval.|"The primary efficacy variable for Part II was the proportion of patients in clinical remission on canakinumab 4 mg/kg (+/- concomitant NSAID only) who were able to remain on a reduced dose or on prolonged dose interval for at least 24 consecutive weeks. As the primary objective was to show statistically significance in at least one of canakinumab treatment arms (reduced dose and prolonged dose interval arms) in Part II then the Type I error rate 5% was controlled and split to 2.5%. Clinical remission per protocol is defined as the maintenance of inactive disease for at least 6 months (24consecutive weeks) while on therapy. The primary analysis considered both inactive disease status and the patient dose step duration.~In the event the inactive disease status was missing, yet the patient remained at the same dose level through the next visit with the same disease status, it was concluded that inactive disease was maintained during this time period and was carried forward."|baseline to 24 weeks|Full Analysis Set|||particiapants|||Number
2589154|NCT02296346|Secondary|Immunological Parameters in Relation to SPMS|Changes in immunological parameters that occur following initiation of ECP or corticosteroids and any relevant correlation with clinical outcomes|2 year|Due to low enrollment numbers and a high dropout rate, there was insufficient data to analyze and correlate treatment with clinical outcomes. Only 2 subjects continued to the 24 month completion, both were corticosteroid patients. No ECP subjects made it to 24 mos. Therefore, there was no analysis performed on the 2 year data.||||||
2589155|NCT02296346|Primary|Multiple Sclerosis Functional Composite (MSFC) Z-score and Expanded Disability Status Scale (EDSS)|"MSFC score is a composite score calculated from 3 tests: 1) Timed 25-Foot walk (leg function); 2) 9-Hole Peg Test (arm function); and 3) Paced Auditory Serial Addition Test (cognitive function). The results are combined to create a single score (the MSFC Z-Score) to measure performance and change over time in subjects with MS. MSFC Z-score = {Z arm + Z leg + Z cognitive} / 3.0. A positive score indicates that, on average, an individual performed better than the reference population and a negative score indicates that, on average, an individual performed worse than the reference population.~The Expanded Disability Status Scale (EDSS) is used to quantify disability due to symptoms of MS and to track changes in disability status over time. Scores range from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Scores are determined by performing a neurological exam and given in increments of 0.5."|1 year|Baseline MSFC and EDSS scores were captured for all 13 subjects, however some subjects withdrew immediately after baseline. Withdrawal of additional subjects continued from that point. Only 1 patient from the ECP arm made it to the 12 month visit. Four patients from the CS arm made it to 12 mos, however 1 of the 4 declined the MSFC tests.|||score on a scale||Full Range|Mean
2589156|NCT02296320|Secondary|Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to MEDI4893|"Participants with ADA-positive at any of Day 31, Day 61, or Day 91 post-baseline assessments were always counted as positive at post-baseline."|Pre-dose on Day 1 (Baseline); and on Days 31, 61, and 91|As-treated population included all participants, who received any dose of study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2589157|NCT02296320|Secondary|Observed Serum Concentration of MEDI4893 Through 90 Days Post Dose (C90)|Observed serum concentration of MEDI4893 through 90 days post dose (C90) is reported. Serum concentration of MEDI4893 through 90 days post dose accounted the overall concentration of MEDI4893 measured on specified time points (Days 1, 4, 8, 15, 22, 31, 61, and 91).|Day 1 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 4, 8, 15, 22, 31, 61, and 90|An ITT population included all randomized participants and were analyzed according to their randomized treatment group. Participants who had quantifiable PK samples were analyzed for this outcome measure.|||μg/mL||Standard Deviation|Mean
2589195|NCT02296112|Secondary|Number of Patients With Each Worst‐Grade Toxicity|Safety profile shown by count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per National Cancer Institute (NCI) common toxicity criteria: grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life‐threatening; grade 5, death.|On‐study date to 30 days following final dose of study drug, up to 3 years|All patients on study.|||participants|||Number
2589158|NCT02296320|Secondary|Observed Serum Concentration of MEDI4893 Through 30 Days Post Dose (C30)|Observed serum concentration of MEDI4893 through 30 days post dose (C30) is reported. Serum concentration of MEDI4893 through 30 days post dose accounted the overall concentration of MEDI4893 measured on specified time points (Days 1, 4, 8, 15, 22, and 30).|Day 1 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 4, 8, 15, 22, and 30|An ITT population included all randomized participants and were analyzed according to their randomized treatment group. Participants who had quantifiable PK samples were analyzed for this outcome measure.|||μg/mL||Standard Deviation|Mean
2589159|NCT02296320|Secondary|Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0-Last]) of MEDI4893|Area under the serum concentration time curve from time zero to last measurable concentration (AUC[0 - Last]) of MEDI4893 is reported.|Day 1 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 4, 8, 15, 22, 31, 61, and 91|An ITT population included all randomized participants and were analyzed according to their randomized treatment group. Participants who had quantifiable PK samples were analyzed for this outcome measure.|||day*μg/mL||Standard Deviation|Mean
2589160|NCT02296320|Secondary|Maximum Observed Serum Concentration (Cmax) of MEDI4893|Maximum observed serum concentration (Cmax) of MEDI4893 is reported.|Day 1 (Pre-dose, end of the infusion, 8 and 24 hours post dose), and on Days 4, 8, 15, 22, 31, 61, and 91|An Intent-to-treat (ITT) population included all randomized participants and were analyzed according to their randomized treatment group. Participants who had quantifiable pharmacokinetic (PK) samples were analyzed for this outcome measure.|||μg/mL||Standard Deviation|Mean
2589161|NCT02296320|Primary|Number of Participants With New Onset Chronic Diseases (NOCDs)|An NOCD defined as a newly diagnosed medical condition that is of a chronic, ongoing nature. It is observed after receiving the study drug and is assessed by the investigator as medically significant.|Day 1 through Day 191|As-treated population included all participants, who received any dose of study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2589162|NCT02296320|Primary|Number of Participants With Adverse Events of Special Interest (AESIs)|An AESI is one of scientific and medical interest specific to understanding of the study drug and may have required close monitoring and rapid communication by the investigator to the sponsor. An AESI may have been serious or non-serious.|Day 1 through Day 191|As-treated population included all participants, who received any dose of study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2589163|NCT02296320|Primary|Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs)|A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.|Day 1 through Day 191|As-treated population included all participants, who received any dose of study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2589164|NCT02296320|Primary|Number of Participants With TEAEs Through 91 Days|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.|Day 1 through Day 91|As-treated population included all participants, who received any dose of study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2589165|NCT02296320|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) Through 31 Days|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.|Day 1 through Day 31|As-treated population included all participants, who received any dose of study drug and analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2589166|NCT02296320|Primary|Percentage of Participants With Endpoint Adjudication Committee-Determined (EAC) Staphylococcus Aureus (S Aureus) Pneumonia|The EAC S aureus pneumonia was based on clinical, radiographic, and microbiologic criteria. Clinical criteria: 1 major criteria (PaO2/FiO2 ratio < 240 mmHg maintained for at least 4 hours or decrease in PaO2/FiO2 by >= 50 mmHg maintained for at least 4 hrs or a need to initiate non-invasive mechanical ventilation or re-initiate invasive mechanical ventilation because of respiratory failure or worsening of respiratory status); and at least 2 of minor criteria (systemic signs of infection, production of purulent sputum/endotracheal secretions, new onset of cough, physical examination findings consistent with pneumonia/pulmonary consolidation, dyspnea, and/or tachypnea). Radiographic criteria: new or worsening infiltrate consistent with pneumonia on chest X-ray obtained within 24 hrs of event. Microbiologic criteria: at least 1 culture positive for S aureus (respiratory specimen, or blood, or pleural fluid aspirate or lung tissue culture during episode of pneumonia).|Day 1 through Day 31|An mITT population included all participants, who received any dose of study drug and analyzed according to their randomized treatment group.|||Percentage of Participants|||Number
2589167|NCT02296242|Other Pre-specified|Pharmacodynamic Results of Inhibition (%) of Molecular Target (ERK Pathway) Assessed by Blood and Tissue Analyses.|Multiple biomarkers intended to demonstrate inhibition of the molecular target, and mechanism of action were investigated from blood and/or bone marrow aspirate samples. Phosphorylation of ERK enzyme substrate proteins (e.g. RSK1 and RSK2 genes) were measured. Additional biomarkers, including PBMCs and/or DNA sequence analysis, were identified and measured as appropriate. Measurements were by ELISA. The pharmacodynamics (PD) population was defined as all patients who received at least one dose of study drug and had sufficient, valid PD samples to estimate key parameters for at least one of the days of sampling.|Patients will be evaluated at baseline and on or about Day 22 of the protocol|Data was not collected/reported for patient at time point or patient did not start a second cycle.|||Percent (%) Inhibition||Standard Deviation|Mean
2589196|NCT02296112|Secondary|Overall Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring.|On‐study date to date of death from any cause (assessed up to 3 years)|All patients on study|||months||95% Confidence Interval|Median
2589168|NCT02296242|Secondary|Duration of Disease Control in Patients That Respond|Assessments were made via bone marrow biopsies using the International Working Group 2003 and 2006 criteria for AML or MDS, respectively. Progression-free survival (PFS) and duration of response (DOR) of AML or MDS patients was assessed in patients treated with BVD-523 that achieved complete remission/response (CR) or complete remission/response with incomplete platelet recovery (CRp). <PR = less than partial remission/response. Shown is the duration (number of days) of CR or CRp response for the 2 patients in part 2 that obtained this level of response.|Until patient discontinuation; ~24 months on average|Part 1: <PR for all data points. Part 2: One patient had a CRp at 2 visits. One patient had a CR.|||Days|||Number
2589169|NCT02296242|Secondary|Clinical Evidence of Cancer Response in Bone Marrow Biopsies|Assessments were made via bone marrow biopsies using the International Working Group 2003 and 2006 criteria for AML or MDS, respectively. Bone marrow assessments (aspiration or biopsy, cytogenetics) were collected prior to therapy on Day 1 and Day 22, every 2 cycles thereafter, as well as at the final study visit if discontinuation was not due to disease progression. Some patients were unable to have bone marrow assessments taken at any or all of the time points. Shown is best response across all time points. Less than partial remission/response (<PR), partial remission/response (PR), complete remission/response with incomplete platelet recovery (CRp), or complete remission/response (CR).|Until patient discontinuation; ~24 months on average||||Response(s)|Response(s)||Count of Units
2589170|NCT02296242|Primary|Steady-state Plasma Concentration of BVD-523 and Selected Metabolites Over 12 Hours|The PK population consisted of patients who received at least one dose of BVD-523 and had evaluable PK data in plasma.|Samples will be collected on or about Day 22 of the protocol|The cohort-expansion patients were not separated by RAS status for the purposes of this assessment. Two patients in the cohort expansion had to have their dose reduced to 300mg BID and were analyzed separately (Cmax 1000 & 1340 ng/mL on Day 22). 00 = not calculated (only 1 evaluable patient).|||ng/mL||Standard Deviation|Mean
2589171|NCT02296242|Primary|Number of Patients With Dose Limiting Toxicities|DLT defined using CTCAE v.4.03. All toxicities were considered to be related to BVD523 if not definitively explained by underlying disease, intercurrent illness, or con meds.|In the first 21 days of treatment||||Participants|||Count of Participants
2589172|NCT02296164|Primary|Treatment Responders Using Body Surface Area (BSA) at 12 Months|The primary efficacy endpoint was the proportion of patients who are responders to treatment at the 12-month timepoint using a ≥50% reduction from baseline in BSA as the definition of a responder in the group of patients who used mechlorethamine plus corticosteroids and possibly another treatment.|12 Months|The primary efficacy endpoint was the proportion of patients who are responders to treatment at the 12-month timepoint using a ≥50% reduction from baseline in BSA as the definition of a responder in the group of patients who used mechlorethamine plus corticosteroids and possibly another treatment.|||Participants|||Count of Participants
2589173|NCT02296138|Secondary|Number of Patients With All-cause Mortality Occurring During the Actual Treatment Period.|Number of patients with all-cause mortality occurring during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with all-cause mortality is presented.|From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days|Treated set (TS) -This patient set includes all randomised patients who were documented to have taken at least 1 dose of trial medication.|||Number of patients|||Number
2589174|NCT02296138|Secondary|Number of Patients With at Least One COPD Exacerbation Leading to Hospitalisation During the Actual Treatment Period.|Number of patients with at least one COPD exacerbation leading to hospitalisation during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with at least one moderate to severe COPD exacerbation leading to hospitalisation is presented.|From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days|Treated set (TS) -This patient set includes all randomised patients who were documented to have taken at least 1 dose of trial medication.|||Number of patients|||Number
2589175|NCT02296138|Secondary|Annualised Rate of Exacerbations Leading to Hospitalisation During the Actual Treatment Period.|Annualised rate of exacerbations leading to hospitalisation during the actual treatment period was calculated per treatment per patient−year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication.|From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days|Treated set (TS) -This patient set includes all randomised patients who were documented to have taken at least 1 dose of trial medication.|||Rate per patient−year||95% Confidence Interval|Least Squares Mean
2589176|NCT02296138|Secondary|Number of Patients With at Least One Moderate to Severe COPD Exacerbation During the Actual Treatment Period.|Key secondary endpoint: Number of patients with at least one moderate to severe COPD exacerbation during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with at least one moderate to severe COPD exacerbation is presented.|From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days|Treated set (TS) -This patient set includes all randomised patients who were documented to have taken at least 1 dose of trial medication.|||Number of patients|||Number
2589177|NCT02296138|Primary|Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period.|Annualised rate of moderate to severe COPD exacerbations during the actual treatment period was calculated per treatment per patient−year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. Least Squares Means are actually exponentiated.|From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days|Treated set (TS) -This patient set includes all randomised patients who were documented to have taken at least 1 dose of trial medication.|||Rate per patient−year||99% Confidence Interval|Least Squares Mean
2602926|NCT02137512|Other Pre-specified|Reported Serious Adverse Events - Extension Phase|Reported serious adverse events during the 5-month extension phase|5 months||||events|||Number
2589178|NCT02296125|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Items (EORTC QLQ-C30)|The EORTC QLQ-C30 cancer-specific questionnaire consisted of 30 questions, combined to produce 5 functional scales, 3 symptom scales, 6 individual items, and a global measure of health status/QoL. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, the functional scales, and the global health status/QoL scale in the EORTC QLQ-C30. Higher scores on the global health status and functioning scales indicated better health status/function. Higher scores on the symptoms scales indicated greater symptom burden. The analysis was performed using a Mixed-effects model for repeated measures analysis on the change from baseline in PRO symptom score at each visit up to 9 months (281 days), including participants, treatment, visit and treatment by visit interaction as explanatory variables, the baseline PRO score as a covariate along with the baseline PRO score by visit interaction, using an unstructured covariance structure.|Questionnaires completed at baseline, first 9 months, and at week 6, 12, 18, 24, 30, and 36.|The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.|||Unit on scale||95% Confidence Interval|Least Squares Mean
2589179|NCT02296125|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ) Questionnaires Lung Cancer 13 (QLQ-LC13)|The EORTC QLQ-LC13 was a lung-cancer-specific module comprising 13 questions to assess lung cancer symptoms (cough, haemoptysis, dyspnoea, and site-specific pain); treatment related side-effects (sore mouth, dysphagia, peripheral neuropathy, and alopecia); and pain medication. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items. Higher scores on the global health status/QoL and functioning scales indicated better health status/QoL and function. Higher scores on the symptoms scales indicated greater symptom burden. The analysis was performed using a Mixed-effects model for repeated measures analysis on the change from baseline in PRO symptom score at each visit up to 9 months (281 days), including participants, treatment, visit and treatment by visit interaction as explanatory variables, the baseline PRO score as a covariate along with the baseline PRO score by visit interaction, using an unstructured covariance structure.|Questionnaires completed at baseline, first 9 months, and at week 1, 2, 3, 4, 5, 6, 12, 18, 24, 30 and 36|The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.|||Unit on scale||95% Confidence Interval|Least Squares Mean
2589180|NCT02296125|Secondary|Participants Reported Outcome by Cancer Therapy Satisfaction Questionnaire 16 Items (CTSQ-16 Questionnaire)|The CTSQ-16 was a 16-item questionnaire measuring 3 domains related to participant's satisfaction with cancer therapy: Expectations of therapy, Feelings about side effects, and Satisfaction with therapy. Scores ranged from 0 to 100 for each domain, with a higher score associated with the best outcome on each domain. The three domains of interest were separately analysed using an ANCOVA stratified by race (Asian versus Non-Asian) and mutation type (Ex19del versus L858R). The results of the analyses were presented in terms of mean together with standard deviation.|Questionnaire completed in cycle 2 and 3, prior to Week 6 scan (approximately 2 months)|The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.|||Unit on scale||Standard Deviation|Mean
2589181|NCT02296125|Secondary|Plasma Concentrations of Metabolite AZ7550|To characterise the pharmacokinetics (PK) of osimertinib metabolite AZ7550.|Blood samples collected from each participant at pre-dose, 0.5 to 2 hours, and 3 to 5 hours post-dose on Day 1 Cycle 1, and every other cycle thereafter up to and including Cycle 13 (approximately 9 months)|The pharmacokinetic analysis set (osimertinib arm only) was defined as participants in the FAS who had at least 1 evaluable PK concentration and who had no detectable pre-dose osimertinib concentrations above the lower limit of quantitation (LLQ) on Cycle 1 Day 1.|||Nano moles||Geometric Coefficient of Variation|Geometric Mean
2589182|NCT02296125|Secondary|Plasma Concentrations of Metabolites AZ5104|To characterise the pharmacokinetics (PK) of osimertinib metabolite AZ5104.|Blood samples collected from each participant at pre-dose, 0.5 to 2 hours, and 3 to 5 hours post-dose on Day 1 Cycle 1, and every other cycle thereafter up to and including Cycle 13 (approximately 9 months)|The pharmacokinetic analysis set (osimertinib arm only) was defined as participants in the FAS who had at least 1 evaluable PK concentration and who had no detectable pre-dose osimertinib concentrations above the lower limit of quantitation (LLQ) on Cycle 1 Day 1.|||Nano moles||Geometric Coefficient of Variation|Geometric Mean
2589183|NCT02296125|Secondary|Plasma Concentrations of AZD9291|To characterise the pharmacokinetics (PK) of osimertinib|Blood samples collected from each participant at pre-dose, 0.5 to 2 hours, and 3 to 5 hours post-dose on Day 1 Cycle 1, and every other cycle thereafter up to and including Cycle 13 (approximately 9 months)|The pharmacokinetic analysis set (osimertinib arm only) was defined as participants in the FAS who had at least 1 evaluable PK concentration and who had no detectable pre-dose osimertinib concentrations above the lower limit of quantitation (LLQ) on Cycle 1 Day 1.|||Nano moles||Geometric Coefficient of Variation|Geometric Mean
2589184|NCT02296125|Secondary|Overall Survival (OS)- Number of Participants With an Event|Overall survival was defined as the time from the date of randomisation until death from any cause and was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy|From first dose to end of study or date of death from any cause, whichever comes first, assessed every 6 weeks (approximately 29 months)|The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.|||Participants|||Count of Participants
2589234|NCT02295020|Primary|KOOS - Sport/Rec|Value at 8 weeks - value at day 0|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.|||units on a scale||95% Confidence Interval|Least Squares Mean
2589185|NCT02296125|Secondary|Depth of Response|The Depth of response was defined as the relative change in the sum of the longest diameters of Response Evaluation Criteria in Solid Tumors (RECIST) Target lesions (TLs) at the nadir, in the absence of new lesions (NLs) or progression of Non-target lesions (NTLs), compared to baseline and was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy|At baseline and every 6 weeks for the first 18 months and then every 12 weeks until objective disease progression|The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.|||percentage of change||Standard Deviation|Mean
2589186|NCT02296125|Secondary|Disease Control Rate (DCR)|The DCR was defined as the percentage of participants who had a best overall response (BOR) of Complete response (CR), Partial response (PR) or Stable disease (SD) ≥6 weeks prior to any Progressive disease (PD) event and was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy.|At baseline and every 6 weeks for the first 18 months and then every 12 weeks until objective disease progression|The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.|||Percentage of participants||95% Confidence Interval|Number
2589187|NCT02296125|Secondary|Duration of Response (DoR)|Duration of response was defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression and was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy.|At baseline and every 6 weeks for the first 18 months and then every 12 weeks until objective disease progression|The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.|||Months||95% Confidence Interval|Median
2589188|NCT02296125|Secondary|Objective Response Rate (ORR)|ORR was defined as the number (%) of participants with measurable disease with at least 1 visit response of Complete response (CR) or Partial response (PR) and it was used to further assess the efficacy of osimertinib compared with SoC EGFR-TKI therapy. ORR was based on Investigator assessment.|At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression|The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.|||Percentage of participants||95% Confidence Interval|Number
2589189|NCT02296125|Primary|Percentage of Participants in Progression Free Survival at 6, 12, and 18 Months|Progression-free survival was defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression and was used to assess the efficacy of single agent osimertinib compared with SoC EGFR-TKI therapy as measured by PFS.|At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression|The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.|||Percentage of participants||95% Confidence Interval|Median
2589190|NCT02296125|Primary|Median Progression Free Survival (PFS) (Months)|Progression-free survival was defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression and was used to assess the efficacy of single agent osimertinib compared with SoC EGFR-TKI therapy as measured by PFS. The primary endpoint of PFS was based on Investigator assessment.|At baseline and every 6 weeks for the first 18 months and then every 12 weeks relative to randomisation until progression|The full analysis set (FAS) and China-only FAS. FAS included all randomized participants prior to the end of global recruitment. The China-only FAS included all China participants randomized in mainland-China as part of the global study and all additional China participants recruited in mainland China after global recruitment was completed.|||Months||95% Confidence Interval|Median
2589191|NCT02296112|Other Pre-specified|Molecular Characteristics of Patient Samples, Including Archival Samples|Molecular characterization of tumor tissue will be performed to identify markers that correlate with clinical responsiveness to treatment with trametinib. Optional on-treatment biopsies will be used to evaluate pharmacodynamic and other molecular effects of treatment, which will be compared to clinical outcomes. Optional post-progression samples will be analyzed to identify mechanisms of resistance.|Up to 3 years|||||||
2589192|NCT02296112|Other Pre-specified|"Clinical Benefit (CR + PR + SD) Per RECIST v. 1.1 in Low Affinity Group"|Per RECIST criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.|Up to 12 months|||||||
2589193|NCT02296112|Other Pre-specified|"Duration of Response in Low Affinity Group"|Estimated probable duration from date of first partial or complete response as defined by RECIST 1.1 criteria to date of disease progression, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >= 20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|Up to 3 years|Patients on study with low activity|||months||95% Confidence Interval|Median
2589235|NCT02295020|Primary|KOOS - ADL|Value at 8 weeks - value at day 0|week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.|||units on a scale||95% Confidence Interval|Least Squares Mean
2589197|NCT02296112|Secondary|"Clinical Benefit (Complete Response [CR] + Partial Response [PR] + Stable Disease [SD]) Per RECIST v. 1.1 in High Affinity Group"|Per RECIST criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.|Up to 12 months|patients with advanced melanoma with High Activity BRAF Mutations or Fusion Events.|||Proportion of participants||95% Confidence Interval|Mean
2589198|NCT02296112|Secondary|"Duration of Response in High Affinity Group"|Estimated probable duration from date of objective response to date of disease progression, using the Kaplan‐Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >= 20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|Date of first partial or complete response as defined by RECIST 1.1 criteria to date of progression up to 3 years|"Patients with advanced melanoma with BRAF high activity"|||months||95% Confidence Interval|Median
2589199|NCT02296112|Secondary|Progression-Free Survival All Patients|Progression of disease as defined by RECIST 1.1 criteria will be reported. Time from on treatment to progression or death (whichever comes first). For those did not progress or die, they were censored at the last follow up or off study date(if they do not have a last date of follow up).|On‐study date to lesser of date of progression or date of death from any cause (assessed up to 3 years)|Patients with advanced melannoma with BRAF non-V600 mutations and received treatment|||months||95% Confidence Interval|Median
2589200|NCT02296112|Primary|"Overall Response Rate in High Affinity Group"|Per RECIST criteria version (v.) 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.|Up to 12 months|patients with advanced melanoma with High Activity BRAF Mutations or Fusion Events.|||Proportion of participants||95% Confidence Interval|Mean
2589201|NCT02296099|Other Pre-specified|Pain at Bedtime (Average Pain)|Before going to bed each night the patient will record the average level of pain using a visual analog scale (VAS). The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.|Day 1||||score on a scale||Inter-Quartile Range|Median
2589202|NCT02296099|Other Pre-specified|Pain at Bedtime (Most Intense Pain)|Before going to bed each night the patient will record the most intense pain using a visual analog scale (VAS). The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.|Day 1||||score on a scale||Inter-Quartile Range|Median
2589203|NCT02296099|Other Pre-specified|Pain at Bedtime (Current Level of Pain)|Before going to bed each night the patient will record their pain level at that moment using a visual analog scale (VAS). The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.|Day 1||||score on a scale||Inter-Quartile Range|Median
2589204|NCT02296099|Other Pre-specified|Number of Participants Reporting 'Very Satisfied' at the 2 Week Postoperative Visit|A likert type scale will be used to have the patient rate their satisfaction with pain control at their two week postoperative visit. Count information for those who were very satisfied were provided.|2 weeks||||Participants|||Count of Participants
2589205|NCT02296099|Secondary|Number of Participants Reporting 'Very Satisfied' at the 1 Week Postoperative Visit|A likert type scale will be used to have the patient rate their satisfaction with pain control at their one week postoperative visit. Count information for those who were very satisfied were provided.|1 week||||Participants|||Count of Participants
2589206|NCT02296099|Secondary|Total Narcotic Consumption|Cumulative consumption postoperative days 1 - 3|Day 1 - 3||||morphine equivalents||Standard Deviation|Mean
2589207|NCT02296099|Secondary|Pain at Four Hours After Discharge Home|A visual analog scale (VAS) will be used to have the patient rate her pain four hours after being discharged home. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.|1 day, 4 hours after discharge from Same Day Surgery||||score on a scale||Inter-Quartile Range|Median
2589208|NCT02296099|Secondary|Pain Upon Discharge From Same Day Surgery|A visual analog scale (VAS) will be used to have the patient rate her pain upon discharge from same day surgery. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.|1 day||||score on a scale||Inter-Quartile Range|Median
2589209|NCT02296099|Secondary|Pain Upon Discharge From Post-anesthesia Care Unit (PACU)|A visual analog scale (VAS) will be used to have the patient rate her pain upon discharge from the PACU. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.|1 day||||score on a scale||Inter-Quartile Range|Median
2589210|NCT02296099|Primary|Pain in the Morning|A visual analog scale (VAS) will be used to have the patient rate her pain in the morning of postoperative day one. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.|Day 1||||scores on a scale||Inter-Quartile Range|Median
2589211|NCT02295995|Secondary|Aerobic Endurance|Aerobic endurance was assessed using the 6-minute walk test (distance).|Baseline and 12 Weeks|2 participants in the usual care (UC) condition did not complete this test at 12 weeks, and were not included in this analysis.|||meters||Standard Error|Mean
2589212|NCT02295995|Primary|PTSD Symptoms|PTSD symptom severity was assessed at both baseline and 12 Weeks using the PTSD Checklist for DSM-V (PCL-5). Scores on the PCL-5 range from 0 to 80, with higher scores indicating more severe PTSD symptoms.|Baseline and 12 Weeks||||score on a scale||Standard Error|Mean
2589213|NCT02295995|Primary|Physical Activity|Activity levels (metabolic equivalent [MET]-minutes/week) were measured using the Aerobic Center Longitudinal Study physical activity questionnaire.|Baseline and 12 Weeks||||metabolic equivalent (MET)-min/week||Standard Error|Mean
2589236|NCT02295020|Primary|KOOS - Symptoms|Value at 8 weeks - value at day 0|Week 8 - Day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.|||units on a scale||95% Confidence Interval|Least Squares Mean
2605737|NCT02107014|Primary|Change in IP-10 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2589214|NCT02295995|Primary|Feasibility of Patient Recruitment|The primary aim/outcome of this pilot study is the feasibility of recruiting older Veterans with PTSD to participate in a 12-week exercise program. The number of Veterans recruited out of the total number contacted will be determined at baseline.|Baseline|701 potentially eligible patients were identified, of which 380 were screened out. Leaving 321 eligible patients (the denominator). Of these 321, 168 declined participation, and 99 were unable to contact; leaving 54 that were enrolled/randomized (numerator).|||Participants|||Count of Participants
2589215|NCT02295774|Secondary|To Evaluate the Staining Quality Obtained With Oral Methylene Blue MMX® Tablets.|"Staining quality (SC) observed in each colonic region, in the FAS set (N=10); mean (±SD) is reported for SC.~SC is ranked as follows:~0 no staining~traces (poor traces in colon mucosa)~detectable (at least the 25% of colon mucosa is stained)~acceptable (at least the 50% of colon mucosa is stained)~good (at least the 75% of colon mucosa is stained)~overstained ( the 100% of the colon mucosa is over stained)"|During the colonoscopy|Full Analysis Set (FAS): all included subjects, who received at least one dose of the IMP and had at least one biopsy for the evaluation of the level of γH2AX post-enrolment. This analysis set was used for the primary analysis|||Units on a 6 point scale||Standard Deviation|Mean
2589216|NCT02295774|Primary|Gamma H2AX Histone Levels in Colonic Biopsy During Standard White Light Colonoscopy and Colonoscopy for Which Methylene Blue MMX Was Taken Prior to Initiating the Colonoscopy|Assay of gamma H2AX histone phosphorylation in biopsy samples collected during colonoscopy.|2 weeks|FAS = 10|||subject biopsies that tested + for γH2AX|||Number
2589217|NCT02295644|Primary|Intraoral Muscle Temperature|Using digital thermometer on buccal mucosa, degrees celsius.|Immediately before and after the intervention, difference used.||||degrees Celsius, post minus pre||Standard Deviation|Mean
2589218|NCT02295644|Primary|Pressure Pain Threshold of the Masseter Muscle|Measuring pressure pain threshold using digital algometer|Immediately before and after the intervention, difference used.||||Kpa/Cm^2||Standard Deviation|Mean
2589219|NCT02295644|Primary|Self Report of Pain|Pain intensity measurement scale from 0 to 10, 0 is no pain, 10 is the worst pain ever|Immediately before and after the intervention, difference used.||||Scores on pain intensity scale||Standard Deviation|Mean
2589220|NCT02295553|Secondary|Incidence of Side Effects and Complications During the Recovery Period|"Side effects including:~hallucinations and/or emergence delirium measured by the Pediatric Anesthesia Emergence Delirium (PAED) scale dizziness nausea and/or vomiting administration of antiemetic pain > 3/10 at any site (measured using age appropriate scale) time to discharge readiness using established criteria reasons for delayed discharge (if any)"|From the time procedure is complete until discharge from hospital with an average time of 1 hour.||||Participants|||Count of Participants
2589221|NCT02295553|Secondary|Incidence of Adverse Respiratory Events During the Procedure|Any respiratory adverse event including desaturation <95 requiring oxygen administration or need for airway management maneuvers (jaw thrust, bag/mask ventilation) to relieve upper airway obstruction|From induction of anesthesia until endoscopy procedure is complete||||Participants|||Count of Participants
2589222|NCT02295553|Secondary|Duration of Apnea After Propofol Administration|The patient will be observed for apnea after propofol is administered until the endoscopy procedure is complete. Duration of apnea will be recorded.|This outcome will be measured after propofol is administered until the end of the procedure.||||seconds||Standard Deviation|Mean
2589223|NCT02295553|Primary|Dose of Propofol Required to Prevent Movement (Response) to Insertion of Endoscope Into the Patient's Esophagus|The objective is to determine the effective bolus dose in 50% of subjects (ED50) of propofol in combination with ketamine 0, 0.25, 0.5 and 1 mg/kg that produces an adequate depth of anesthesia to prevent minimal or no movement on endoscope insertion in children|This outcome is measured at the time of insertion of the endoscope into the esophagus.|Dose of propofol required to prevent movement upon insertion of endoscope|||mg/kg||95% Confidence Interval|Mean
2589224|NCT02295280|Primary|Number of Participants With Adequate Relief of Headache as a Measure of Efficacy|Number of participants with reduction in pain scores six hours post administration by at least 2 on the pain score scale.|Primary outcome was six hours post administration|Number in each arm with data at 6 hours who received either metoclopramide and diphenhydramine IV or codeine.|||Participants|||Count of Participants
2589225|NCT02295020|Primary|Visual Analog Scale|identifies pain level|Day 0 and Week 8|The outcome was not measured as KOOS was measured as the only patient reported outcome.||||||
2589226|NCT02295020|Primary|WOMAC|assess pain, stiffness, and physical function measured by Western Ontario and McMaster universities Osteoarthritis Index|Day 0 and Week 8|The outcome was not measured as KOOS was measured as the only patient reported outcome.||||||
2589227|NCT02295020|Primary|Oxford Knee Score||Day 0 and Week 8|The outcome was not measured as KOOS was measured as the only patient reported outcome.||||||
2589228|NCT02295020|Primary|Synovial Fluid Analysis (MCP - 1)|Monocyte chemotactic protein-1 - 1|Week 8 -day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.|||pg/mL||Full Range|Median
2589229|NCT02295020|Primary|Synovial Fluid Analysis (MIP - 1alpha)|Macrophage Inflammatory Proteins - 1alpha|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.|||pg/mL||Full Range|Median
2589230|NCT02295020|Primary|Synovial Fluid Analysis (TNF-alpha)|Tumor necrosis factor - alpha in Synovial fluid analysis|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.|||pg/mL||Full Range|Median
2589231|NCT02295020|Primary|Synovial Fluid Analysis (IL-8)|Interleukine 8 in Synovial fluid analysis|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.|||pg/mL||Full Range|Median
2589232|NCT02295020|Primary|Synovial Fluid Analysis (IL-6)|Interleukine 6 in Synovial fluid analysis|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to either synovial fluid not present in the knee or not sufficient to be analyzed.|||pg/mL||Full Range|Median
2589233|NCT02295020|Primary|KOOS - QOL|Value at 8 weeks - value at day 0|Week 8 - day 0|Discrepancies between participants flow chart and number of participants analyzed is due to patients not filling out the survey.|||pg/mL||95% Confidence Interval|Least Squares Mean
2589239|NCT02294786|Secondary|Proportion of Subjects Contacting Other Non-hospital Healthcare Professionals to Discuss Diarrhoea as Recorded in the DMD|The proportion of subjects contacting a health care professional other than the hospital doctors/nurses to discuss diarrhoea are summarised|Up to 24 weeks|ITT|||Participants|||Count of Participants
2589240|NCT02294786|Secondary|Proportion of Subjects Making Dietary Changes Due to Diarrhoea as Recorded in the DMD|The proportion of subjects making dietary changes to help with the diarrhoea are summarised|Up to 24 weeks|ITT|||Participants|||Count of Participants
2589241|NCT02294786|Secondary|Proportion of Subjects Taking Anti-diarrhoeal Medication as Recorded in the DMD|The proportion of subjects taking medication at least once as a result of diarrhoea are summarised|Up to 24 weeks|ITT|||Participants|||Count of Participants
2589242|NCT02294786|Secondary|Time to the First Subject Reported Change in Frequency and/or Consistency of Bowel Movements From Baseline as Recorded in the DMD|Event is defined as Subjects reporting change in frequency and/or consistency of bowel movements from baseline at least once in DMD. Subject are censored if there is no change in bowel movement frequency/consistency as compared to baseline. Median time and 95% confidence intervals were calculated using Kaplan-Meier estimates.|Up to 24 weeks|ITT|||Days||95% Confidence Interval|Median
2589243|NCT02294786|Secondary|Proportion of Subjects Reporting Changes in Bowel Movements From Baseline (Frequency and/or Consistency) as Recorded in the Diarrhoea Management Diary (DMD)|All subjects completed the baseline DMD during the 3 days prior to randomisation, before any study-related treatment is administered. Subjects randomised to receive Octreotide completed a second baseline DMD before starting the first cycle of treatment with Lapatinib and Capecitabine. The baseline DMD comprised of 3 questions to record stool form and consistency. The DMD to be completed throughout the rest of the study comprised of 3 questions in the baseline DMD and a further 5 questions and 6 sub-questions to evaluate the consequences and management of diarrhoea.|Up to 24 weeks|ITT|||Participants|||Count of Participants
2589244|NCT02294786|Secondary|Clinical Benefit Response (up to 24 Weeks)|"Clinical benefit response as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.~Clinical Benefit Response rate (CBR) is defined as the percentage of subjects with a CR, PR or SD at week 24."|Up to 24 weeks|ITT|||Participants|||Count of Participants
2589245|NCT02294786|Secondary|Overall Response Rate (up to 24 Weeks)|Overall response rate as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) >=20% and >= 5mm increase in the sum of diameters of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Up to 24 weeks|ITT|||Participants|||Count of Participants
2589246|NCT02294786|Secondary|Number of Lapatinib and Capecitabine Tablets Dispensed and Returned|Number of Lapatinib and Capecitabine tablets dispensed and returned as recorded in the eCRF|Up to 24 weeks|ITT|||tablets||Standard Deviation|Mean
2589247|NCT02294786|Secondary|Proportion of Subjects Requiring Use of Diarrhoea-related Intravenous Fluids|Proportion of subjects requiring use of diarrhoea-related intravenous fluids for rehydration as recorded in the eCRF|Up to 24 weeks|ITT - The information to calculate the proportions was not captured in the database.||||||
2589248|NCT02294786|Secondary|Proportion of Subjects Requiring Treatment Withdrawal in Lapatinib and Capecitabine|Proportion of subjects requiring diarrhoea related Lapatinib and Capecitabine treatment withdrawal as recorded in the eCRF|Up to 24 weeks|ITT|||Participants|||Count of Participants
2589249|NCT02294786|Secondary|Proportion of Subjects Requiring Dose Delay in Lapatinib and Capecitabine|Proportion of subjects requiring diarrhoea related Lapatinib and Capecitabine dose delay as recorded in the eCRF|Up to 24 weeks|ITT|||Participants|||Count of Participants
2589250|NCT02294786|Secondary|Proportion of Subjects Requiring Dose Reduction in Lapatinib and Capecitabine|Proportion of subjects requiring diarrhoea related Lapatinib and Capecitabine dose reduction as recorded in the eCRF|Up to 24 weeks|ITT|||Participants|||Count of Participants
2589251|NCT02294786|Secondary|Proportion of Subjects Who Had Unscheduled Visits to Healthcare Professionals Due to Diarrhoea|Proportion of subjects making diarrhoea related unscheduled visits to healthcare professionals as recorded in the eCRF|Up to 24 weeks|ITT - The information to calculate the proportions was not captured in the database.||||||
2589252|NCT02294786|Secondary|Proportion of Subjects Taking Anti-diarrhoeal Medication|Proportion of subjects taking anti-diarrhoeal medication as recorded in the eCRF|Up to 24 weeks|ITT|||Participants|||Count of Participants
2589253|NCT02294786|Secondary|Time to Onset of the First Episode of Diarrhoea of Any Grade of Severity|Time to onset of the first episode of diarrhoea of any grade of severity, recorded as an AE in the eCRF. Subject are censored if there was no event. Median time and 95% confidence intervals were calculated using Kaplan-Meier estimates.|Up to 24 weeks|ITT|||Days||95% Confidence Interval|Median
2589254|NCT02294786|Secondary|Duration of Diarrhoea of Any Grade of Severity|Duration of diarrhoea of any grade of severity, recorded as AEs in the eCRF|Up to 24 weeks|ITT - including only patients for whom an AE of diarrhoea and its duration was reported|||days||Standard Deviation|Mean
2589255|NCT02294786|Secondary|Proportion of Subjects Experiencing Diarrhoea of Any Grade of Severity (up to 24 Weeks)|Proportion of subjects experiencing diarrhoea of any grade of severity as defined by the NCI CTCAE, version 4.03 and recorded as AEs in the eCRF|Up to 24 weeks|ITT|||Participants|||Count of Participants
2589256|NCT02294786|Secondary|Proportion of Subjects Experiencing Diarrhoea of Grade 3 and Above (up to 24 Weeks)|Proportion of subjects experiencing diarrhoea with a severity of Grade 3 and above, as defined by the NCI CTCAE, version 4.03 and recorded as AEs in the eCRF|Up to 24 weeks|ITT|||Participants|||Count of Participants
2589311|NCT02294474|Secondary|Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions|Percentage of participants with hypersensitivity reactions and injection site reactions were reported.|First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)|Analysis was performed on safety population.|||percentage of participants|||Number
2589257|NCT02294786|Primary|Proportion of Subjects Experiencing Diarrhoea of Grade 2 and Above (up to 24 Weeks)|Proportion of subjects experiencing at least one episode of diarrhoea with a severity of Grade 2 and above, as defined by the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE) version 4.03, recorded as AEs in the Electronic case report form (eCRF)|Up to 24 weeks|ITT - For cycle 1-3 analysis: Subjects that withdrew from the study on or prior to the Cycle 4 visit date were assumed to have experienced diarrhoea. For the cycle 1-8 analysis: Subjects who did not have diarrhea event prior to the End of Study/Withdrawal visit date were not assumed to have experienced diarrhoea.|||Participants|||Count of Participants
2589258|NCT02294773|Other Pre-specified|Pregnancy Rate Per Body Mass Index Category||Up to cycle day 35||||pregnancies per cycle|||Number
2589259|NCT02294773|Other Pre-specified|Pregnancy Rate Per Semen Morphology Score|Comparison of pregnancy rate based on semen morphology of <4% vs >4% normal morphology scores.|Up to cycle day 35||||pregnancies per cycle|||Number
2589260|NCT02294773|Other Pre-specified|Pregnancy Rate Per Female Partner Age|Pregnancy rate will be compared between patients <35 and >35 at time of study entry.|Up to cycle day 35||||pregnancies per cycle|||Number
2589261|NCT02294773|Other Pre-specified|Per Cycle Pregnancy Rate Based on Infertility Diagnosis||Up to cycle day 35||||pregnancies per cycle|||Number
2589262|NCT02294773|Primary|Number of Pregnancies Achieved Per Menstrual Cycle.||Up to 3 months||||pregnancies per cycle|||Number
2589263|NCT02294734|Secondary|Number of Participants With Treatment Failures|Treatment failure types are presented as: recurrent exacerbations, prolonged treatment of current exacerbation (beyond 14 days), additional treatment with systemic / oral corticosteroids and / or antibiotics, and requirement for invasive mechanical ventilation.|13 weeks|ITT Population|||Participants|||Number
2589264|NCT02294734|Secondary|Questionnaires CAT and MMRC Scale at Baseline, Day 28 and Day 84|The chronic obstructive pulmonary disease (COPD) assessement test (CAT) and Modified Medical Research Council (MMRC) Dyspnea Scale were completed at the indicated timepoints: Baseline, Day 28 and Day 84. CAT and MMRC scales are prestned as: 1.I never cough/I cough all the time 2.I have no phelgm in my chest at all/My chest is completely full of phelgm 3. My chest does not feel tight at all/My chest feels very tight 4.Walk up hilll or stairs not breathless/Walk up hill or stairs very breathless 5. Not limited doing any home activities/Very limited doing any home activities 6. Confident leaving home/No confident leaving home 7. I sleep soundly/I don't sleep soundly because of my lung condition and 8. I have lots of energy/I have no energy at all. Baseline is defined as the assessment on Day 1. Score 0 indicates not troubled with breathlessness to 4:too breathless. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 28 and Day 84|ITT Population|||Scores on a scale||Standard Deviation|Mean
2589265|NCT02294734|Secondary|Change From Baseline in Specific Conductance (sGaw) After 28 Days and After 84 Days of Treatment|Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).Note: values mentioned as 95% confidence interval below are in fact values of 95% Credible Interval.|Baseline, Day 28 and Day 84|ITT Population|||1/KPA*S||95% Confidence Interval|Median
2589266|NCT02294734|Secondary|Change From Baseline in Specific Resistance (sRaw) After 28 Days and After 84 Days of Treatment|sRaw is the measure of specific resistance. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 28 and Day 84|ITT Population|||KPa*s||Standard Deviation|Mean
2589267|NCT02294734|Secondary|Change From Baseline in Functional Residual Capacity After 28 Days and After 84 Days of Treatment|Functional residual capacity is the volume of air present in the lungs at the end of passive expiration. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 28 and Day 84|ITT Population|||L||Standard Deviation|Mean
2589268|NCT02294734|Secondary|Change From Baseline in Residual Volume After 28 Days and After 84 Days of Treatment|Residual volume is a lung volume representing the amount of air left in the lungs after a forced exhalation. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Note: values mentioned as 95% confidence interval below are in fact values of 95% credible interval.|Baseline, Day 28 and Day 84|ITT Population|||L||95% Confidence Interval|Median
2589269|NCT02294734|Secondary|Change From Baseline in Total Lung Capacity (TLC) After 28 Days and After 84 Days of Treatment|TLC is the maximum amount of air that can fill the lungs. Baseline is defined as the assessment on Day 2 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Note: values mentioned as 95% confidence interval below are in fact values of 95% credible interval.|Baseline, Day 28 and Day 84|ITT Population|||L||95% Confidence Interval|Median
2589270|NCT02294734|Secondary|Percent Change From Baseline in Diffusion Capacity (DLco, Kco) After 28 Days and After 84 Days of Treatment|DLco is diffusing capacity o f the lungs for carbon monoxide and is defined as the extent to which oxygen passes from the air sacs of the lungs into the blood. KCO is the carbon monoxide transfer coefficient. It is an index of the efficiency of alveolar transfer of carbon monoxide. Baseline is defined as the assessment on Day 2 and percent change from Baseline is the post-Baseline value minus Baseline value/100. Change from Baseline data is presented for Day 28 and Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 28 and Day 84|ITT Population|||Percent||Standard Deviation|Mean
2589334|NCT02294396|Secondary|Change From Baseline in Postvoid Residual (PVR) Volume|Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study.|Baseline and week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|SAF|||mL||Standard Deviation|Mean
2589271|NCT02294734|Secondary|Changes From Baseline in Peak Expiratory Flow (PEF) Measured Daily|PEF is the maximal flow (or speed) achieved during the maximally forced expiration initiated at full inspiration. Baseline is defined as the assessment on Day 1 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 28, and Day 84|ITT Population|||L/min||Standard Deviation|Mean
2589272|NCT02294734|Secondary|Changes From Baseline in Forced Expiratory Volume in One Second (FEV1) Measured Daily|FEV1 is the volume of air that can forcibly be blown out in one second. A triplicate FEV1 measurement were taken daily in the morning before dose administration. Baseline is defined as the assessment on Day 1 and change from Baseline is the post-Baseline value minus Baseline value. Change from Baseline data is presented for Day 28 and Day 84.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 28, and Day 84|ITT Population|||mL||Standard Deviation|Mean
2589273|NCT02294734|Secondary|Trough Concentration After 12 Days, 28 Days, 56 Days and 84 Days of Treatment|Trough concentrations are presented for Pre-dose Day 12, Pre-dose Day 28, Pre-dose Day 56, and Pre-dose Day 84. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Pre-dose Day 12, Day 28, Day 56, and Day 84|PK Population|||pg/mL||Standard Deviation|Mean
2589274|NCT02294734|Secondary|Day 1 Plasma Concentration up to 24 Hours (Hrs) Post-dose|Plasma samples were collected at pre-dose, 5 minutes (min), 3 hrs, and 24 hrs post-dose on Day 1. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Pharmacokinetic (PK) Population: all participants in the Safety Population for whom a PK sample was obtained and analyzed. Safety Population comprises of all participants who were randomized.|Pre-dose, 5 min, 3 hrs and 24 hrs|Pharmacokinetic (PK) Population|||pg/mL||Standard Deviation|Mean
2589275|NCT02294734|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG)|12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF). Clinically non-significant (CN) and Clinically significant (CS) abnormal ECG measurements are presented for Day 1, Day 12, Day 28, Day 56, Day 84, follow-up/Early withdrawal and at any visit post-baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)|All Subject Population|||Participants|||Number
2589276|NCT02294734|Secondary|Number of Participants With Abnormal Vital Signs|Vital signs included high and low diastolic and systolic blood presure (BP), and high and low heart rate (HR). Vital signs outside the range of potential clinical importance are presented at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, follow-up/Early withdrawal and at any visit post-baseline . Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)|All Subject Population|||Participants|||Number
2589277|NCT02294734|Secondary|Number of Participants With Abnormal Clinical Chemistry Parameters|Clinical Chemistry parameters included Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Calcium (Ca), Glucose, Potassium (K), Sodium (Na), and Total Bilirubin (TBL) at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, and at follow-up/Early withdrawal. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 days)|All Subject Population|||Participants|||Number
2589278|NCT02294734|Secondary|Number of Participants With Abnormal Hematology Parameters|Hematology parameter included Hematocrit (HCT), Hemoglobin (HB), Lymphocytes (LC), Platelet Count (PC), Total Neutrophils (TN), and White Blood Cell (WBC) count at the indicated timepoints: Day 1, Day 12, Day 28, Day 56, Day 84, and at follow-up/Early withdrawal. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Day 1, Day 12, Day 28, Day 56, Day 84 and at follow-up (approximately 100 Days)|All Subjects Population|||Participants|||Number
2589279|NCT02294734|Secondary|Number of Participants With Adverse Events (AE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were collected from the start of study treatment until the follow-up contact.|From start of IP through the Study Phase (84 days post-dose) (assessed up to follow-up duration of approximately 100 days)|All Subjects Population: all randomized participants who received at least one dose of study treatment.|||Participants|||Number
2589280|NCT02294734|Secondary|Change From Baseline in Imaging Trachea Length/Diameter After 12 Days of Treatment and After 28 Days of Treatment|Imaging trachea length/diameter was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. TLC is the volume in the lungs at maximal inflation and FRC is the volume in the lungs at the end-expiratory position. The Baseline for the assessment on Day 12 and Day 28 is the Screening value. Change from Baseline is the post-Baseline value minus the Baseline value. The change from Baseline data is presented for Day 12 and Day 28 for trachea length/diameter. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 12 and Day 28|ITT Population excluding the subject with a pacemaker.|||ratio||Standard Deviation|Mean
2589281|NCT02294734|Secondary|Change From Baseline in Imaging Trachea Length and Diameter After 12 Days of Treatment and After 28 Days of Treatment|Imaging trachea length and diameter was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. TLC is the volume in the lungs at maximal inflation and FRC is the volume in the lungs at the end-expiratory position. The Baseline for the assessment on Day 12 and Day 28 is the Screening value. Change from Baseline is the post-Baseline value minus the Baseline value. The change from Baseline data is presented for Day 12 and Day 28 for trachea length and diameter. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Day 12 and Day 28|ITT Population excluding the subject with a pacemaker.|||Millimeter (mm)||Standard Deviation|Mean
2589743|NCT02289989|Secondary|Rate Cosmetic Acceptability of Topical Agents|The patient or caregiver rated how the product felt on their skin after applying the product, measuring the cosmetic acceptability on day 7 and 14. The scale was excellent, good, moderate and poor.|On day 7 and 14||||participants|||Number
2589282|NCT02294734|Secondary|Change From Baseline in Lung Lobar Volumes Measured at FRC and TLC Scan Conditions, Presented in Longitudinal Scan Types, Measured in 5 Lobes and 5 Regions at Day 12 and Day 28|Change from Baseline in lung lobar volumes was measured at functional residual volume (FRC) and total lung capacity (TLC) scan conditions. Data was collected at longitudinal time points: Day 12 & Day 28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For longitudinal time points the baseline is screening. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).|Baseline, Day 12 and Day 28|ITT Population excluding the subject with a pacemaker.|||L||95% Confidence Interval|Geometric Mean
2589283|NCT02294734|Secondary|Change From Baseline in Imaging Specific Airways Resistance: siRaw Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28|siRaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).|Baseline, Day 12 and Day 28|ITT Population excluding the subject with a pacemaker.|||Kpa*s||95% Confidence Interval|Geometric Mean
2589284|NCT02294734|Secondary|Change From Baseline in Imaging Airways Resistance ( iRaw) Measured at FRC and TLC Scan Conditions, Presented in Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28|iRaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).|Baseline, Day 12 and Day 28|ITT Population excluding the subject with a pacemaker.|||Kilopascal (Kpa)*s/L||95% Confidence Interval|Geometric Mean
2589285|NCT02294734|Secondary|Change From Baseline in Imaging Airways Volume: iVaw, Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28|iVaw was derived from HRCT to evaluate the effect of once daily inhaled dose of GSK2269557 on lung parameters. Data was collected at longitudinal time points: Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For longitudinal time points and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).|Baseline, Day 12 and Day 28|ITT Population excluding the subject with a pacemaker.|||Milliliter (mL)||95% Confidence Interval|Geometric Mean
2589286|NCT02294734|Primary|Change From Baseline in Specific Imaging Airway Volume (siVaw), Measured at FRC and TLC Scan Conditions, Presented in Longitudinal and Scan Trimmed Scan Types, Measured in 5 Lobes and 5 Regions at Screening, Day 12 and Day 28|siVaw is a measure of the volume in an individual's airway corrected for their lobar volume derived from the high resolution computed tomography (HRCT). It was measured at functional residual volume (FRC) and total lung capacity (TLC). Data was collected at longitudinal time points: Screening, Day 12 & Day 28 and at each time point for scan trimmed pairs: SCRD12, SCRD28 & D12D28. At each time point it was measure at 5 lobes (RUL, LUL, RML, RLL & LLL) and 5 Regions (Upper, Lower, Central, Distal & Total). For longitudinal time points and SCRD12 & SCRD28 scan trimmed pairs the baseline is screening, for D12D28 scan trimmed pair the baseline is D12. Change from baseline is the post-Baseline value minus the Baseline value. Only particpants available at the specified time point were analysed (represented by n=X1, X2 in the category title).|Baseline, Day 12 and Day 28|Intention to Treat (ITT) Population excluding the subject with a pacemaker.|||Milliliter/Liter (mL/L)||95% Confidence Interval|Geometric Mean
2589287|NCT02294682|Secondary|Number of Participants With Abnormal Urinalysis Dipstick Results|Dipstick urinalysis was done for glucose, ketones, occult blood, protein, potential hydrogen (pH) and specific gravity at Baseline visit Day 1 (pre-dose) and Test-of-Cure visit (Day 4 to 8). Results were presented as negative (normal) or other findings reported only if observed under microscopic examination trace, 1+, 2+, 3+, 4+ and 5+ glucose, ketones, occult blood and protein. pH results were categorized as per their pH values. Baseline was defined as the study assessment on Day 1 (pre-dose). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||Participants|||Number
2589288|NCT02294682|Secondary|Change From Baseline in Erythrocytes Mean Corpuscular Volume at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate erythrocytes mean corpuscular volume. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC Visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||Femtoliters||Standard Deviation|Mean
2589289|NCT02294682|Secondary|Change From Baseline in Erythrocytes Mean Corpuscular Hemoglobin at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate erythrocytes mean corpuscular hemoglobin. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC Visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||Picograms||Standard Deviation|Mean
2589290|NCT02294682|Secondary|Change From Baseline in Erythrocytes at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate erythrocytes (red blood cell count). Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)||||10^12/L||Standard Deviation|Mean
2589291|NCT02294682|Secondary|Change From Baseline in Chloride, Calcium, Glucose, Potassium, Sodium and Urea at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1.(pre-dose) and at TOC visit (Day 4 to 8) to evaluate chloride, calcium, glucose, potassium, sodium and urea (blood urea nitrogen). Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||Millimole (MMOL)/L||Standard Deviation|Mean
2589292|NCT02294682|Secondary|Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase and Alkaline Phosphatase at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1.(pre-dose) and at TOC visit (Day 4 to 8) to evaluate alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||International units (IU)/ L||Standard Deviation|Mean
2589293|NCT02294682|Secondary|Change From Baseline in Bilirubin, Direct Bilirubin and Creatinine at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate bilirubin, direct bilirubin and creatinine. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||Micromole (UMOL)/ L||Standard Deviation|Mean
2589294|NCT02294682|Secondary|Change From Baseline in Lymphocyte, Monocyte, Neutrophil Basophil, Eosinophil, Leukocyte and Platelet Count at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate neutrophil, lymphocyte, basophil, eosinophil, monocyte, leukocyte and platelet count. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||10^9 cells/L||Standard Deviation|Mean
2589295|NCT02294682|Secondary|Change From Baseline in Hematocrit at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate hematocrit. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||Proportion of blood||Standard Deviation|Mean
2589296|NCT02294682|Secondary|Change From Baseline in Hemoglobin, Protein and Albumin at Test-of-Cure Visit (Day 4 to 8)|Blood samples were collected at Baseline Day 1 (pre-dose) and at TOC visit (Day 4 to 8) to evaluate hemoglobin, total protein and albumin. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as value obtained at TOC visit minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||Gram (G)/Liter (L)||Standard Deviation|Mean
2589297|NCT02294682|Secondary|Number of Participants With Abnormal Physical Examination Finding|Physical examination of respiratory, cardiovascular, abdomen, gastrointestinal, urogenital systems, pharyngeal and rectal examinations with collections of microbiology specimen was performed at the Baseline and TOC (Day 4 to 8) visit. Baseline was defined as the study assessment on Day 1 (pre-dose). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit and Test-of-Cure visit (Day 4 to 8)|Safety Population|||Participants|||Number
2589298|NCT02294682|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|A single 12-lead ECGs were obtained at the Baseline, 2 hour post-dose, and at the TOC (Day 4 to 8) visit using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. ECG was obtained prior to any vital sign measurements or blood draws scheduled on the same assessment day. For participants enrolled under protocol amendment 1, ECG was measured at Baseline visit Day 1 (pre-dose) only. ECG assessments were presented as abnormal-clinically significant (CS) and abnormal-not clinically significant (NCS) at the indicated time points. Only those participants available at the specified time points were analyzed (represented by n=X , X in the category titles).|Baseline visit and up to Day 8|Safety Population|||Participants|||Number
2589299|NCT02294682|Secondary|Change From Baseline in Respiratory Rate at the Indicated Time Points|Respiratory rate was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendement 1 and up to TOC visit (Day 4 to 8). Vital sign measurements was obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC Visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit (Day 1) and Day 4 to Day 8|Safety Population|||Breaths per minute||Standard Deviation|Mean
2589323|NCT02294461|Secondary|Concentration 24 h After Dosing (C24h) Enzalutamide, M1,M2 and Enzalutamide Plus M2|N is the number of participants with available data at this time point.|From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1 and Multiple Dosing Day 85|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.|||μg/mL||Standard Deviation|Mean
2589300|NCT02294682|Secondary|Change From Baseline in Temperature at the Indicated Time Points|Temperature was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendement 1 and up to TOC visit (Day 4 to 8). Vital sign measurements were obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit (Day 1) and Day 4 to Day 8|Safety Population|||Celsius||Standard Deviation|Mean
2589301|NCT02294682|Secondary|Change From Baseline in Pulse Rate at the Indicated Time Points|Pulse rate was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendement 1 and up to TOC visit (Day 4 to 8). Vital sign measurements were obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit (Day 1) and Day 4 to Day 8|Safety Population|||Beats per minute||Standard Deviation|Mean
2589302|NCT02294682|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at the Indicated Time Points|BP was measured in semi-supine position after 5 minutes rest. It was recorded at Baseline visit, 2 hour post-dose visit for participants enrolled under orignal protocol, 0.5 hour post-dose for participants enrolled under protocol amendement 1 and up to TOC visit (Day 4 to 8).Vital sign measurements were obtained prior to any scheduled blood collection visit on the same assessment day. Baseline was defined as the study assessment on Day 1 (pre-dose). Change from Baseline was calculated as TOC visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline visit (Day 1) and Day 4 to Day 8|Safety Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2589303|NCT02294682|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a clinical investigation participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia (defined as alanine aminotransferase [ALT] >=3 times upper limit of normal [ULN] and bilirubin >=2 times ULN [>35 percent direct] [or ALT >=3 times ULN and international normalization ratio INR>1.5, if INR is measured].|From start of the study treatment until Test-of-Cure visit (Day 4 to 8)|Safety Population: comprised of all randomized participants who received any dose of study medication.|||Participants|||Number
2589304|NCT02294682|Primary|Number of Participants With Culture-confirmed Bacterial Eradication of Urogenital Neisseria Gonorrhoeae at the Test-of-Cure Visit|Pre-treatment urogenital, pharyngeal, and rectal swab specimens were obtained for bacteriological culture for neisseria (N.) gonorrhoeae at the Baseline visit. Test- of-Cure was defined by infection site (that is urogenital and, as appropriate, rectal and/or pharyngeal) as culture confirmed bacterial eradication of N. gonorrhoeae observed 3 to 7 days post-treatment. Pre-treatment urogenital specimens were obtained for nucleic acid amplification test (NAAT) assay to detect the presence of N. gonorrhoeae and chlamydia trachomatis at the Baseline visit. Only participants who had a pre-therapy N. gonorrhoeae isolate recovered from their urogenital specimen were evaluated. Microbiologically evaluable (ME) Population comprised of all randomized participants who had N. gonorrhoeae isolated from Baseline cultures of urogenital swab specimens, received any dose of gepotidacin, and returned for their TOC visit.|Baseline (Day 1, pre-dose) and Test-of-Cure visit (Day 4 to 8)|ME Population|||Participants|||Number
2589305|NCT02294604|Secondary|Duration of Hand Washing|The secondary outcome is the duration of hand washing|Immediately||||Minute||Standard Error|Mean
2589306|NCT02294604|Secondary|Microorganisms on Hands After Surgery|The secondary outcomes is the colonies grown on bacterial culture plate|2 days after sampling||||colony forming unit||Standard Error|Mean
2589307|NCT02294604|Secondary|Microorganisms on Hands After Scrubbing|The secondary outcomes is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates|2 days after sampling||||colony forming unit||Standard Error|Mean
2589308|NCT02294604|Primary|Microorganisms on Hands Before Scrubbing|The primary outcome is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates|2 days after sampling||||colony forming unit||Standard Error|Mean
2589309|NCT02294474|Other Pre-specified|Change in Daily Insulin Dose From Baseline to Week 26|Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Week 26 value.|Baseline, Week 26|Analysis was performed on safety population. Here, number analyzed in each row = participants with available data for specified categories.|||U/kg||Standard Deviation|Mean
2589310|NCT02294474|Secondary|Percentage of Participants With Treatment-Emergent Anti-insulin Antibodies (AIAs)|Participants with treatment-emergent AIA (incidence) were reported (as participants with treatment-boosted or treatment-induced AIAs). Participants with treatment-induced AIAs were participants who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample). Participants with treatment-boosted AIAs were participants with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period, in those participants with pre-existing AIA).|First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)|Analysis was performed on anti-insulin antibody population that included all participants from the safety population with at least one AIA sample available for analysis during the 6-months on-treatment period.|||percentage of participants|||Number
2589744|NCT02289989|Secondary|Measure Presence of S. Aureus Colonization on Affected Skin|Bacterial culture of the affected area was done on day 0 and day 14.|Baseline to day 14||||participants|||Number
2589312|NCT02294474|Secondary|Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia)|Percentage of participants with at least one treatment emergent hypoglycemia reported at any time of the day were reported. Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (3.9 mmol/L). Hypoglycemic episodes with plasma glucose of 54 mg/dL (<3.0 mmol/L) were also analyzed.|First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)|Analysis was performed on safety population that included all participants randomized and exposed to at least 1 dose of investigational medicinal product (IMP) (SAR342434 or Humalog), regardless of the amount of treatment administered.|||percentage of participants|||Number
2589313|NCT02294474|Secondary|Change in Post Prandial Glucose (PPG) Excursion From Baseline to Week 26|Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour postprandial glucose (PPG) minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as average across the profiles performed in the week before the visit. Change in PPG excursions was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the 6-month period and adequate contrasts at Week 26.|Baseline, Week 26|Analysis was performed on ITT population. Here, number analyzed in each row = participants with at least one post-baseline data during the 6-month period for specified categories.|||mmol/L||Standard Error|Least Squares Mean
2589314|NCT02294474|Secondary|Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26|The mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. 7-point SMPGs were performed at least two times in a week before baseline, before visit Week 12 and before visit Week 26. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in the week before a visit. Change in mean 24-hour plasma glucose concentration was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during 6-month period and adequate contrasts at Week 26.|Baseline, Week 26|Analysis was performed on ITT population. Here, number of participants analyzed = participants with at least one post-baseline mean 24-hour plasma glucose concentration assessment during 6-month study period.|||mmol/L||Standard Error|Least Squares Mean
2589315|NCT02294474|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM approach to account for missing data, using all post-baseline FPG data available during the 6-month period and adequate contrasts at Week 26.|Baseline, Week 26|Analysis was performed on ITT population. Here, number of participants analyzed = participants with at least one post-baseline FPG assessment during the 6-months study period.|||mmol/L||Standard Error|Least Squares Mean
2589316|NCT02294474|Secondary|Percentage of Participants With HbA1c <7.0% and <=6.5% at Week 26|Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.|Week 26|Analysis was performed on ITT population.|||percentage of participants|||Number
2589317|NCT02294474|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the 6-month period and adequate contrasts at Week 26.|Baseline, Week 26|Analysis was performed on intent-to-treat (ITT) population that included all randomized participants, irrespective of compliance with the study protocol and procedures. Here, number of participants analyzed = participants with at least one post-baseline HbA1c assessment during the 6-month study period.|||percentage of HbA1c||Standard Error|Least Squares Mean
2589318|NCT02294461|Secondary|Number of Participants With Adverse Events|The Treatment-Emergent Adverse Events are defined as AEs with a possible or probable relationship to study drug. If participant was still on study drug at the analysis data cutoff date, then the length of the treatment-emergent period was calculated through the cutoff date.|From first dose of study drug up to data cut off date of 20 Sept 2015|Safety Analysis Set consisted of all randomized participants who received at least 1 dose of study drug.|||Participants|||Number
2589319|NCT02294461|Secondary|AUC From the Time of Dosing to the Start of the Next Dosing Interval (AUCtau) Enzalutamide, M1,M2 and Enzalutamide Plus M2||From randomization up to data cutoff date of 20 Jan 2016; Multiple Dosing Day 85|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.|||μg·h/mL||Standard Deviation|Mean
2589320|NCT02294461|Secondary|Peak-Trough Ratio (PTR) Enzalutamide, M1,M2 and Enzalutamide Plus M2||From randomization up to data cutoff date of 20 Jan 2016; Multiple Dosing Day 85|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.|||Ratio||Standard Deviation|Mean
2589321|NCT02294461|Secondary|Apparent Total Systemic Clearance After Multiple Dosing (CL/F) Enzalutamide, M1,M2 and Enzalutamide Plus M2 (For Unchanged Enzalutamide Only)||From randomization up to data cutoff date of 20 Jan 2016; Multiple Dosing Day 85|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.|||L/h||Standard Error|Mean
2589322|NCT02294461|Secondary|Observed Plasma Concentration in Predose Samples Obtained During Multiple-dose Administration of Minimum Concentration (Plasma Concentration at Pre Dose) (Cmin) Enzalutamide, M1,M2 and Enzalutamide Plus M2|N is the number of participants with available data at this time point.|From randomization up to data cutoff date of 20 Jan 2016; Day 2, 3, 8, 22, 29, 43, 57, 85, 86, 113, 141 and 169|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at least 1 time point.|||μg/mL||Standard Deviation|Mean
2589324|NCT02294461|Secondary|AUC From the Time of Dosing to 24 h After Dosing (AUC24h) Enzalutamide, M1,M2 and Enzalutamide Plus M2||From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point. Number of participants analyzed is the number of participants with available data at this time point.|||μg·h/mL||Standard Deviation|Mean
2589325|NCT02294461|Secondary|Maximum Observed Plasma Concentration During the First 24 Hours After Dosing (Cmax) Enzalutamide, M1,M2 and Enzalutamide Plus M2||From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1 and Multiple Dosing Day 85|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.|||μg/mL||Standard Deviation|Mean
2589326|NCT02294461|Secondary|Time to Maximum Concentration (Tmax) of Enzalutamide, M1,M2 and Enzalutamide Plus M2||From randomization up to data cutoff date of 20 Jan 2016; Single Dosing Day 1 and Multiple Dosing Day 85|The Pharmacokinetic Analysis Set (PKAS) population consisted of all participants who received at least 1 dose of study drug and who provided blood samples for drug concentrations at at least 1 time point.|||(h)||Full Range|Median
2589327|NCT02294461|Secondary|Best Overall Soft Tissue Response|Participants with measurable soft tissue disease at screening visit (i.e., at least one target lesion per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) who have an objective response (complete response (CR) or partial response (PR)) during the study were included in the best overall soft tissue response assessment. The best overall soft tissue response was based on the investigator assessment using RECIST 1.1.|From randomization up to data cut off date of 20 Sept 2015; median treatment duration is 6.60 months for enzalutamide and 3.70 months for placebo|The Intent-to-Treat (ITT) population consisted of all randomized participants in the study.|||Participants|||Number
2589328|NCT02294461|Secondary|Number of Participants With Confirmed Best PSA Response (≥50% Decrease From Baseline)|Best PSA response was defined as as ≥50% reductions in PSA level from baseline to the lowest post-baseline PSA result as determined by the central laboratory, with a consecutive assessment conducted at least 3 weeks later to confirm the PSA response. Only participants who had both baseline and post-baseline assessments were included in the analysis.|Baseline up to data cut off date of 20 Sept 2015; median treatment duration is 6.60 months for enzalutamide and 3.70 months for placebo|The Intent-to-Treat (ITT) population consisted of all randomized participants in the study.|||Participants|||Number
2589329|NCT02294461|Secondary|Time to Initiation of Cytotoxic Chemotherapy|Time to initiation of cytotoxic chemotherapy was defined as the time from randomization to initiation of cytotoxic chemotherapy. It included only therapies for prostate cancer. When multiple cytotoxic chemotherapies were initiated, the first chemotherapy was used to determine the time to event. Participants who did not start cytotoxic chemotherapy at the time of analysis data cutoff were censored at the date of their last assessment indicating no evidence of cytotoxic chemotherapy usage.|From randomization up to data cutoff date of 20 Sept 2015; median follow-up time is 7.39 months for enzalutamide and 4.93 months for placebo|The Intent-to-Treat (ITT) population consisted of all randomized participants in the study.|||Months||95% Confidence Interval|Median
2589330|NCT02294461|Secondary|Time to First Skeletal-Related Event|Time to first skeletal-related event (SRE) was defined as the time from randomization to the first skeletal-related event, defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of anti-neoplastic therapy to treat bone pain. Participants who have not had a SRE at the time of the analysis were censored at their last assessment indicating no evidence of SRE.|From randomization up to data cutoff date of 20 Sept 2015; median follow-up time is 7.39 months for enzalutamide and 5.29 months for placebo|The Intent-to-Treat (ITT) population consisted of all randomized participants in the study.|||Months||95% Confidence Interval|Median
2589331|NCT02294461|Secondary|Duration of Radiographic Progression-free Survival (rPFS) Based on Independent Central Review Facility Assessment|Duration of Radiographic Progression-free Survival (rPFS) was defined as the time from randomization to the rPFS event (deaths from any cause and radiographic disease progression). Radiographic disease progression is defined by RECIST 1.1 for soft tissue disease, or PCWG2 for bone lesions. If a participant met the criteria for more than 1 censoring rule, they were censored with the earliest censoring date. The radiographic progression date was the first date when progression definition was met, not confirmed.|From randomization up to data cutoff date of 20 Sept 2015; median follow-up time is 5.55 months for enzalutamide and 3.71 months for placebo|Intent-to-Treat (ITT) population consisted of all randomized participants in the study.|||Months||95% Confidence Interval|Median
2589332|NCT02294461|Secondary|Duration of Overall Survival|Duration of overall survival was defined as the time from the randomization to deaths from any cause. For participants who were alive at the time of the data analysis, overall survival time was censored to the last know date the participants were known to be alive or data analysis cutoff date, whichever occurred first.|From randomization up to data cutoff date of 20 Sept 2015; median follow-up time is 8.02 months for enzalutamide and 5.55 months for placebo|The Intent-to-Treat (ITT) population consisted of all randomized participants in the study.|||Months||95% Confidence Interval|Median
2589333|NCT02294461|Primary|Time to Prostate-specific Antigen (PSA) Progression|The time to Prostate Specific Antigen (PSA) progression was defined as the time from randomization to the PSA progression. The PSA progression was defined according to the consensus guidelines of Prostate Cancer Clinical Trials Working Group 2 (PCWG2).For participants with PSA decline at Week 13, the PSA progression date was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir, which would be confirmed by a second consecutive value obtained 3 or more weeks later. For participants with no PSA decline at Week 13, the PSA progression date was defined as the date when a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline was documented, which was confirmed by a second consecutive value 3 or more weeks later. PSA progression at the time of the data analysis cutoff date could only be declared on or after week 13. Time to PSA progression was estimated using the Kaplan-Meier method. Participants without confirmed PSA progression were censored.|From randomization up to data cut off date of 20 Sept 2015; median follow-up time is 7.33 months for enzalutamide and 3.02 months for placebo|The Intent-to-Treat (ITT) population consisted of all randomized participants in the study.|||Months||95% Confidence Interval|Median
2589335|NCT02294396|Secondary|Number of Participants Who Achieved Normalization of the Mean Number of Nocturia Episodes Per 24 Hours|Normalization for the mean number of nocturia episodes per 24 hours was defined as no nocturia episode per 24 hours.|Week 52 (end of treatment)|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis.|||Participants|||Count of Participants
2589336|NCT02294396|Secondary|Change From Baseline in the Mean Number of Nocturia Episodes Per Night|"Participants completed the patient diary (paper document) for 3 days immediately before each visit. A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable urinated was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis."|Baseline and week 4, 8, 12, 16, 28, 40, 52|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis.|||nocturia episodes||Standard Deviation|Mean
2589337|NCT02294396|Secondary|Change From Baseline in the Mean Volume Voided Per Micturition|"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was > 0 and where urinary incontinence was not indicated in the patient diary, divided by the number of micturitions where the volume voided was > 0 and where urinary incontinence was not indicated. Only participants who had volume voided was > 0 at baseline was included in the analysis."|Baseline and week 4, 8, 12, 16, 28, 40, 52|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis.|||mL||Standard Deviation|Mean
2589338|NCT02294396|Secondary|Change From Baseline in the Mean Number of Urge Incontinence Episodes Per 24 Hours|"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency and urinary incontinence' were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis."|Baseline and week 4, 8, 12, 16, 28, 40, 52|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis.|||urge incontinence episodes||Standard Deviation|Mean
2589339|NCT02294396|Secondary|Number for Participants Who Achieved Normalization of the Mean Number of Incontinence Episodes Per 24 Hours|Normalization for the mean number of incontinence episodes per 24 hours was defined as no incontinence episode per 24 hours.|Week 52 (end of treatment)|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis.|||Participants|||Count of Participants
2589340|NCT02294396|Secondary|Change From Baseline in the Mean Number of Incontinence Episodes Per 24 Hours|"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinary incontinence' was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis."|Baseline and week 4, 8, 12, 16, 28, 40, 52|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis|||incontinence episodes||Standard Deviation|Mean
2589341|NCT02294396|Secondary|Number for Participants Who Achieved Normalization of the Mean Number of Urgency Episodes Per 24 Hours|Normalization for the mean number of urgency episodes per 24 hours was defined as no urgency episode per 24 hours.|Week 52 (end of treatment)|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis.|||Participants|||Count of Participants
2589342|NCT02294396|Secondary|Change From Baseline in the Mean Number of Urgency Episodes Per 24 Hours|"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis."|Baseline and week 4, 8, 12, 16, 28, 40, 52|FAS participants with available data at each time point are included in the analysis.A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis.|||urgency episodes||Standard Deviation|Mean
2589384|NCT02293863|Secondary|Elimination Half-Life (Terminal t1/2) of MHAA4549A||30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)|PK−evaluable population included all participants, who received MHAA4549A and from whom evaluable PK samples were obtained.|||day||Standard Deviation|Mean
2589343|NCT02294396|Secondary|Number for Participants Who Achieved Normalization of the Mean Number of Micturitions Per 24 Hours|Normalization for the mean number of micturitions per 24 hours was defined as < 8 micturitions per 24 hours.|Week 52 (end of treatment)|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis.|||Participants|||Count of Participants
2589344|NCT02294396|Secondary|Change From Baseline in the Mean Number of Micturitions Per 24 Hours|"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinated was indicated, divided by the number of days on which episodes were recorded."|Baseline and week 4, 8, 12, 16, 28, 40, 52|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis.|||micturitions||Standard Deviation|Mean
2589345|NCT02294396|Secondary|Change From Baseline in OAB-q SF Total HRQL Score|The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline.|Baseline and week 12, 28 and 52|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis.|||units on a scale||Standard Deviation|Mean
2589346|NCT02294396|Secondary|Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Symptom Severity Score|The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Symptom Severity and the Health-related Quality of Life (HRQL). The Symptom Severity section included 6 questions. For each participant, the symptom severity score was derived as a sum of scores for Questions 1 to 6. The total score ranges from 6 to 36 with higher symptom severity score indicating greater symptom bother. OAB-q SF data obtained at week 0 visit were used as baseline.|Baseline and week 12, 28 and 52|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis.|||units on a scale||Standard Deviation|Mean
2589347|NCT02294396|Secondary|Number of Participants Who Achieved Normalization for OABSS Total Score|Normalization for OABSS Total Score was defined as OABSS total score ≤ 2 or OABSS Question 3 score ≤ 1.|Week 52 (end of treatment)|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis.|||Participants|||Count of Participants
2589348|NCT02294396|Secondary|Change From Baseline in Overactive Bladder Symptom Score (OABSS) Total Score|The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline.|Baseline and week 4, 8, 12, 16, 28 and 52|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of treatment) was performed to ensure all participants with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of treatment analysis.|||units on a scale||Standard Deviation|Mean
2589349|NCT02294396|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator.|From first dose of study drug up to week 52|SAF|||Participants|||Count of Participants
2589350|NCT02294318|Primary|Mean Number of Drinks Per Day (QuantDD)|This outcome was derived from a Timeline Follow Back (TLFB) completed at the end of the intervention (day 60).|60 days||||standard drinks||Standard Deviation|Mean
2589351|NCT02294318|Primary|Mean Number of Drinking Days (NumDD)|This outcome was derived from a Timeline Follow Back (TLFB) completed at the end of the intervention (day 60).|60 days||||days||Standard Deviation|Mean
2589352|NCT02294318|Primary|Mean Dollar Amount Spent Per Day on Primary Drug (QuantU)|This outcome was derived from a Timeline Follow Back (TLFB) completed at the end of the intervention (day 60).|60 days||||dollars||Standard Deviation|Mean
2589353|NCT02294318|Primary|Mean Number of Days Used Primary Drug (NumDU)|This outcome was derived from a Timeline Follow Back (TLFB) completed at the end of the intervention (day 60).|60 days||||days||Standard Deviation|Mean
2589354|NCT02294253|Primary|Successful Induction Onto XR-NTX|Proportion of participants inducted onto XR-NTX at the end of the 30-day buprenorphine/naloxone stabilization/taper.|One week after completing 30-day buprenorphone/naloxone stabilization/taper.||||Participants|||Count of Participants
2589355|NCT02294227|Secondary|Number of Participants With American College of Rheumatology 20 (ACR20) Response|The ACR20 response is defined by at least 20% decrease in the swollen and tender joint count, and at least 20% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire - Diability Index, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]. ACR20 is used to assess the efficacy of secukinumab, with or without loading, versus placebo|4 weeks|Full Analysis Set (FAS): all subjects from the randomized set to whom study treatment has been assigned.|||Participants|||Count of Participants
2589356|NCT02294227|Secondary|Number of Participants With American College of Rheumatology 50 (ACR50)|"The ACR50 response is defined by at least 50% decrease in the swollen and tender joint count, and at least 50% improvement in 3 of the following 5 criteria: Health Assessment Questionnaire, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)].~ACR50 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.~This table is the ACR50 response using non-responder imputation and rescue penalty up to Week 16"|16 weeks|Full Analysis Set (FAS): all subjects from the randomized set to whom study treatment has been assigned.|||Participants|||Count of Participants
2589357|NCT02294227|Secondary|Short Form Health Survey Physical Component Score (SF-36-PCS)|SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|16 weeks|Full Analysis Set (FAS): all subjects from the randomized set to whom study treatment has been assigned.|||scores on a scale||Standard Error|Least Squares Mean
2589358|NCT02294227|Secondary|Psoriatic Area and Severity Index 75 (PASI75)|"PASI is a measure of disease activity based on extent of the disease, severity of erythema, scaling and thickness in different body areas affected by psoriasis. PASI75 is an improvement in the PASI score of at least 75% compared to baseline. PASI75 is used to assess the efficacy of secukinumab, with or without loading, versus placebo.~PASI75 response using non-responder imputation and rescue penalty up to Week 16"|16 weeks|The psoriasis subset included all full analysis set (FAS) patients who had ≥3% of the body surface area (BSA) affected by psoriatic skin involvement at baseline.|||Participants|||Count of Participants
2589359|NCT02294227|Secondary|Disease Activity Score (DAS-C28-CRP) Score Change From Baseline Using MMRM at Week 16|"DAS28-CRP score change from baseline using MMRM up to Week 16. DAS-CRP values range between 2.0 and 10. The higher the score, the higher the disease severity.~n: Number of subjects with measures at both baseline and the corresponding post baseline visit."|week 16|Full Analysis Set (FAS): all subjects from the randomized set to whom study treatment has been assigned.|||scores||Standard Error|Least Squares Mean
2589360|NCT02294227|Primary|Number of Participants With American College of Rheumatology 20 (ACR20) Response|"The ACR20 response is defined by at least 20% decrease in the swollen and tender joint count, and at least 20% improvement in 3 of the following 5 criteria:~Health Assessment Questionnaire - Disability Index, pain score on a visual analog scale, patient global assessment of disease activity, physician global assessment of disease activity and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]. ACR20 is used to assess the efficacy of secukinumab, with or without loading, versus placebo."|16 weeks|Full Analysis Set (FAS): all subjects from the randomized set to whom study treatment has been assigned.|||Participants|||Count of Participants
2589361|NCT02294175|Secondary|Satisfaction: Wound Pain, Day 8|Satisfaction survey to measure satisfaction with debridement method, aesthetic questions regarding debridement, ease of use/care, and wound pain. Pain was measured using the Defense and Veterans Pain Rating Scale (DVPRS). Individual item scores range from 0 to 10, with higher scores on the DVPRS indicating higher pain and worse outcomes.|Day 8|Statistical analysis was performed on a subset of participants (n=30) due to missing data on one or more measures.|||DVPRS (Pain) Score||Standard Deviation|Mean
2589362|NCT02294175|Secondary|Satisfaction: Difficulty of Use/Care, Day 8|Survey item score for Difficulty of Use/Care of debridement. This item is from a Satisfaction with Debridement survey. Individual item scores range from 0 to 10, with higher scores on the difficulty item indicating worse outcome (higher difficulty of use/care for debridement method).|Day 8|Statistical analysis was performed on a subset of participants (n=31) due to missing data on one or more measures.|||score on a scale||Standard Deviation|Mean
2589363|NCT02294175|Secondary|Satisfaction: Aesthetic Unpleasantness of Debridement, Day 8|Survey item score for Aesthetic Unpleasantness of debridement. This item is from a Satisfaction with Debridement survey. Individual item scores range from 0 to 10, with higher scores on the aesthetic unpleasantness item indicating worse outcomes|Day 8|Statistical analysis was performed on a subset of participants (n=32) due to missing data on one or more measures.|||score on a scale||Standard Deviation|Mean
2589364|NCT02294175|Secondary|Satisfaction With Debridement: Overall Satisfaction With Method, Day 8|Satisfaction (Overall) item score. This item is from a Satisfaction with Debridement survey, designed to measure satisfaction with debridement method, aesthetic questions regarding debridement, ease of use/care, and wound pain. Individual item scores range from 0 to 10, with higher scores indicating better outcomes (higher overall satisfaction).|Day 8|Statistical analysis was performed on a subset of participants (n=30) due to missing data on one or more measures.|||score on a scale||Standard Deviation|Mean
2589365|NCT02294175|Secondary|Inflammatory Biomarker IL6|The levels of active IL6 was calculated using Enzyme Linked Immunosprbent Assay (ELISA) and reported in ng/ml. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores indicate worse outcomes.|Day 0 (Baseline), Day 4, Day 8|Statistical analysis was performed on a subset of participants (n=27) due to missing data on one or more days of measurement.|||Natural Log Transformed IL6 in ng/ml||Standard Deviation|Mean
2589366|NCT02294175|Secondary|Inflammatory Biomarker MMP-9|Using Enzyme Linked Immunosprbent Assay (ELISA), the levels of active Matrix Metalloproteinase type 9 (MMP-9) was calculated and expressed as pg/ml of wound fluid and pg/mg protein. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores indicate worse outcomes.|Day 0 (Baseline), Day 4, Day 8|Statistical analysis was performed on a subset of participants (n=20) due to missing data on one or more days of measurement.|||Natural Log Transformed MMP-9 in pg/ml||Standard Deviation|Mean
2589745|NCT02289989|Primary|Histological Improvement Measured by Confocal Microscopy|Confocal microscopy was done to the patient on day 0, day 14 and day 28. Due to technical difficulties, this outcome measure was not collected.|Baseline to day 28|Data not collected||||||
2589367|NCT02294175|Secondary|Reviewer Assessment of Visible Wound Improvement|"For each patient, wound photos were taken at days 0, 4, and 8 and given to wound specialists. Wound specialists reviewed photos to assess whether there was visible reduction in amount of necrotic or non-viable tissue remaining in the wound bed at day 8--i.e., whether the wound appeared to be improved (yes vs. no). The percentage of reviewers (out of 4) who responded yes that the wound appeared improved was calculated for each patient. Thus, each patient received a score for percentage of reviewers who saw visual improvement; the means and standard deviations for these percentages were compared between LDT and SDT groups. Higher scores correspond to better outcomes (higher proportion of reviewers who responded that wounds appeared visibly improved)."|Day 8||||percentage of reviewers||Standard Deviation|Mean
2589368|NCT02294175|Primary|Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed),With Phenylethyl Alcohol (PEA) Plating|Differences in total bacterial colony forming units (CFUs) between LDT and SDT arms at Day 0, with Phenylethyl Alcohol (PEA) plating. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores correspond to a greater number of bacterial CFUs (i.e., worse outcome).|Day 0 (Baseline), Day 4, Day 8|Statistical analysis was performed on a subset of participants (n=33) due to missing data on one or more days of measurement.|||Natural Log Transformed Bacterial CFU||Standard Deviation|Mean
2589369|NCT02294175|Primary|Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With MacConkey Agar Plating|Differences in total bacterial colony forming units (CFUs) between LDT and SDT arms at Day 0, with MacConkey Agar plating. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores correspond to a greater number of bacterial CFUs (i.e., worse outcome).|Day 0 (Baseline), Day 4, Day 8|Statistical analysis was performed on a subset of participants (n=33) due to missing data on one or more days of measurement.|||Natural Log Transformed Bacterial CFU||Standard Deviation|Mean
2589370|NCT02294175|Primary|Total Bacteria Colony Forming Units (CFUs; Natural-log Transformed), With Tryptic Soy Agar (TSA) Plating|Differences in total bacterial colony forming units (CFUs) between LDT and SDT arms at Day 0, with Tryptic Soy Agar (TSA) plating. Raw outcomes were natural-log transformed due to skewed distribution. Higher scores correspond to a greater number of bacterial CFUs (i.e., worse outcome).|Day 0 (Baseline), Day 4, Day 8|Statistical analysis was performed on a subset of participants (n=32) due to missing data on one or more days of measurement.|||Natural Log Transformed Bacterial CFU||Standard Deviation|Mean
2589371|NCT02294019|Secondary|Percentage of Participants Taking Greater Than (>) 400 mg (>1 Caplet) at a Time on no More Than 2 Dosing Occasions During the Study|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if the total number of dosing occasions (distinct usage date/time values from their diary) in which a participant received 2 or more caplets was 0, 1 or 2. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking no more than 1 caplet per dose, under the advice of a healthcare professional, based on the end of study follow up interview.|Day1 up to 30 days|Actual use population included all participants who purchased the study medication and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.|||percentage of participants||95% Confidence Interval|Number
2589372|NCT02294019|Primary|Percentage of Participants Taking Greater Than (>) 1200 Milligram (mg) (>3 Caplets) on no More Than 2 Use Days During the Study|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants took more than 1200 mg (>3 caplets) on either 0, 1 or 2 use days (where a use day was defined as a calendar day starting at 12:01 AM in which a participant received at least one dose of study medication), based on their diary. The behavior was considered acceptable if a participant exceeded the labelled daily dosing directions of taking more than 3 caplets per day, under the advice of a healthcare professional, based on information from the end of study follow-up interview.|Day 1 up to 30 days|Actual use population included all participants who purchased the study medication and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.|||percentage of participants||95% Confidence Interval|Number
2589373|NCT02293902|Secondary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters|"Criteria for potentially clinically significant abnormalities:~Alanine Aminotransferase (ALT): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN~Aspartate aminotransferase (AST): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN~Alkaline phosphatase: >1.5 ULN~Total bilirubin (TBILI): >1.5 ULN; >2 ULN~Conjugated bilirubin (CBILI): >1.5 ULN; >2 ULN~Unconjugated bilirubin: >1.5 ULN; >2 ULN~ALT and TBILI: ALT >3 ULN and TBILI >2 ULN~CBILI and TBILI: CBILI >35% TBILI and TBILI >1.5 ULN~Albumin: <=25 g/L"|For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm : Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58|Analysis was performed on safety population.|||participants|||Number
2589374|NCT02293902|Secondary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters|"Criteria for potentially clinically significant abnormalities:~Creatinine: >=150 micromol/L; >=30% change from baseline; >=100% change from baseline~Creatinine clearance: <15 mL/min; >=15 to <30 mL/min; >=30 to < 60 mL/min; >=60 to <90 mL/min~Blood urea nitrogen: >=17 mmol/L~Uric acid: <120 micromol/L; >408 micromol/L"|For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58|Analysis was performed on safety population.|||participants|||Number
2589375|NCT02293902|Secondary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes|"Criteria for potentially clinically significant abnormalities:~Sodium: <=129 mmol/L; >=160 mmol/L~Potassium: <3 mmol/L; >=5.5 mmol/L~Chloride: <80 mmol/L; >115 mmol/L"|For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58|Analysis was performed on safety population.|||participants|||Number
2589420|NCT02292849|Secondary|Changes in Hamilton Depression Rating Scale Scores|Hamilton Depression Rating Scale mean change scores from baseline to 12 weeks. This scale measures severity of depressive symptoms (range=0-76), with higher scores indicating more sever depressive symptomatology.|Baseline and 12 weeks|Randomized clients|||units on a scale||Standard Deviation|Mean
2589376|NCT02293902|Secondary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters|"Criteria for potentially clinically significant abnormalities:~Glucose: <=3.9 mmol/L and <LLN; >=11.1 mmol/L unfasted or >=7 mmol/L fasted~Hemoglobin A1c (HbA1c): >8%~Total cholesterol: >=6.2 mmol/L; >=7.74 mmol/L~LDL cholesterol: >=4.1 mmol/L; >=4.9 mmol/L~Triglycerides: >=4.6 mmol/L; >=5.6 mmol/L"|For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58|Analysis was performed on safety population.|||participants|||Number
2589377|NCT02293902|Secondary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters|"Criteria for potentially clinically significant abnormalities:~Hemoglobin: <=115 g/L (Male[M]) or <=95 g/L (Female[F]); >=185 g/L (M) or >=165 g/L (F); DFB >=20 g/L~Hematocrit: <=0.37 v/v (M) or <=0.32 v/v (F); >=0.55 v/v (M) or >=0.5 v/v (F)~Red blood cells (RBC): >=6 Tera/L~Platelets: <50 Giga/L; >=50 and <100 Giga/L; >=700 Giga/L~White blood cells (WBC): <3.0 Giga/L (Non-Black[NB]) or <2.0 Giga/L (Black[B]); >=16.0 Giga/L~Neutrophils: <1.5 Giga/L (NB) or <1.0 Giga/L (B); <1.0 Giga/L~Lymphocytes: <0.5 Giga/L; >=0.5 Giga/L and < lower limit of normal (LLN); >4.0 Giga/L~Monocytes: >0.7 Giga/L~Basophils: >0.1 Giga/L~Eosinophils: >0.5 Giga/L or >upper limit of normal (ULN) (if ULN >=0.5 Giga/L)"|For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58|Analysis was performed on safety population.|||participants|||Number
2589378|NCT02293902|Secondary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities|"Criteria for potentially clinically significant ECG abnormalities:~PR Interval: >200 millisecond (ms); >200 ms and IFB >=25%; >220 ms; >220 ms and IFB >=25%; >240 ms; >240 ms and IFB >=25%~QRS Interval: >110 ms; >110 ms and IFB >=25%; >120 ms; >120 ms and IFB >=25%~QT Interval: >500 ms~QTc Bazett (QTc B): >450 ms; 480 ms; 500 ms; IFB >30 and <=60 ms; IFB >60 ms~QTc Fridericia (QTc F): >450 ms; 480 ms; 500 ms; IFB >30 and <=60 ms; IFB >60 ms"|For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58|Analysis was performed on safety population.|||participants|||Number
2589379|NCT02293902|Secondary|Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities|"Criteria for potentially clinically significant vital sign abnormalities:~Systolic blood pressure supine (SBP[S]): <=95 mmHg and decrease from baseline (DFB) >=20 mmHg; >=160 mmHg and increase from baseline (IFB) >=20 mmHg~Diastolic blood pressure supine (DBP[S]): <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB >=10 mmHg~Orthostatic systolic blood pressure (SBP[O]): <=-20 mmHg~Orthostatic diastolic blood pressure (DBP[O]): <=-10 mmHg~Heart rate supine (HR[S]): <=50 beats per minute (bpm) and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm~Weight: >=5% DFB; >=5% IFB"|For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58|Analysis was performed on safety population.|||participants|||Number
2589380|NCT02293902|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AEs that developed or worsened or became serious during double-blind on-treatment period, single-blind on-treatment period up to 6-week post-treatment follow-up period (up to Week 58) were considered treatment-emergent.|For placebo arm: Baseline up to Week 24; For sarilumab 150 mg/150 mg, sarilumab 200 mg/200 mg and sarilumab rescue arm: Baseline up to Week 58; For placebo/sarilumab 150 mg and placebo/sarilumab 200 mg arm: Week 25 up to Week 58|Analysis was performed on safety population which included all randomized participants who actually received at least one dose or a partial dose of IMP.|||participants|||Number
2589381|NCT02293902|Primary|Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24|American College of Rheumatology (ACR) response is a composite rating scale that includes 7 variables: tender joints count (TJC [68 joints]); Swollen joints count (SJC [66 joints]); levels of an acute phase reactant (high sensitivity C-reactive protein [hs-CRP level]); participant's assessment of pain (measured on 0 [no pain]-100 mm [worst pain] visual analog scale [VAS]); participant's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by health assessment questionnaire disability index [HAQ-DI], with scoring range of 0 [better health] - 3 [worst health]). ACR20 response was defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments.|Week 24|Analysis was performed on modified intent-to-treat (mITT) population which included all randomized participants who received at least one dose of investigational medicinal product (IMP) and had an evaluable primary endpoint, irrespective of compliance with the study protocol and procedures.|||percentage of participants|||Number
2589382|NCT02293863|Secondary|Observed Steady State Volume of Distribution (Vss_obs) of MHAA4549A||30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)|PK−evaluable population included all participants, who received MHAA4549A and from whom evaluable PK samples were obtained.|||mL||Standard Deviation|Mean
2589383|NCT02293863|Secondary|Observed Clearance (CL-obs) of MHAA4549A||30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)|PK−evaluable population included all participants, who received MHAA4549A and from whom evaluable PK samples were obtained.|||mL/day||Standard Deviation|Mean
2605738|NCT02107014|Primary|Change in SDF-1α From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2589385|NCT02293863|Secondary|Maximum Serum Concentration (Cmax ) of MHAA4549A||30 min before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)|PK−evaluable population included all participants, who received MHAA4549A and from whom evaluable PK samples were obtained.|||mcg/mL||Standard Deviation|Mean
2589386|NCT02293863|Secondary|Area Under Serum Concentration-Time Curve From Time 0 to Infinity (AUC ) of MHAA4549A|AUC0-inf is reported as day*microgram/milliliter (day*mcg/mL).|30 minutes (min) before & 60 min after end of MHAA4549A infusion (infusion duration = 120 min) on Day 1; immediately prior to oseltamivir dose on Days 2, 3, 5, 7; on Days 14, 30; on day of discharge (up to Day 60); at study completion (Day 60)|Pharmacokinetic (PK)−evaluable population included all participants, who received MHAA4549A and from whom evaluable PK samples were obtained.|||day*mcg/mL||Standard Deviation|Mean
2589387|NCT02293863|Secondary|Duration of Ventilation||From randomization up to 60 days|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization. Here, number analyzed are the participants who were evaluable for this outcome measure.|||days||80% Confidence Interval|Median
2589388|NCT02293863|Secondary|Percentage of Participants Readmitted to Hospital Due to Any Cause||Days 30 and 60|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization.|||percentage of participants||80% Confidence Interval|Number
2589389|NCT02293863|Secondary|Percentage of Participants With Secondary Complications of Influenza|The following were considered secondary complications of influenza: pneumonia, including hospital-acquired pneumonia (HAP) and ventilation-acquired pneumonia (VAP), exacerbations of chronic lung disease, myocarditis, acute respiratory distress syndrome (ARDS), otitis media, or other related complications.|From randomization up to 60 days|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization.|||percentage of participants||80% Confidence Interval|Number
2589390|NCT02293863|Secondary|Percentage of Participants Using Antibiotics for Respiratory Infections||From randomization up to 60 days|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization.|||percentage of participants||80% Confidence Interval|Number
2589391|NCT02293863|Secondary|Duration of Intensive Care Unit (ICU) Stay||From randomization up to 60 days|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization. Here, number analyzed are the participants who were evaluable for this outcome measure.|||days||80% Confidence Interval|Median
2589392|NCT02293863|Secondary|Duration of Hospitalization||From randomization up to 60 days|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization.|||days||80% Confidence Interval|Median
2589393|NCT02293863|Secondary|Duration of Viral Shedding|Influenza A viral load was measured by qPCR in nasopharyngeal samples at multiple time points during the study. Reported here is the duration of viral shedding.|Immediately prior to MHAA4549A infusion and oseltamivir dosing on Day 1, immediately prior to oseltamivir dosing on Days 2 to 10, Days 14, 20, 25, 30, on day of discharge from hospital (up to Day 60), and at study completion (Day 60)|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization. Here, number analyzed are the participants who were evaluable for this outcome measure.|||days||80% Confidence Interval|Median
2589394|NCT02293863|Secondary|Peak Influenza A Viral Load|Influenza A viral load was measured by qPCR in nasopharyngeal samples at multiple time points during the study. Reported here is the peak Influenza A viral load expressed as log10 vp/mL.|Immediately prior to MHAA4549A infusion and oseltamivir dosing on Day 1, immediately prior to oseltamivir dosing on Days 2 to 10, Days 14, 20, 25, 30, on day of discharge from hospital (up to Day 60), and at study completion (Day 60)|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization. Here, number analyzed are the participants who were evaluable for this outcome measure.|||log10 vp/mL||Standard Deviation|Mean
2589395|NCT02293863|Secondary|Area Under Viral Load-Time Curve (AUEC ) of Influenza A Virus|Influenza A viral load was measured by quantitative polymerase chain reaction (qPCR) in nasopharyngeal samples at multiple time points during the study. AUEC is the area under the viral load-time curve expressed as log10 (viral particles/milliliter x hour) = log10 (vp/mL x hour).|Immediately prior to MHAA4549A infusion and oseltamivir dosing on Day 1, immediately prior to oseltamivir dosing on Days 2 to 10, Days 14, 20, 25, 30, on day of discharge from hospital (up to Day 60), and at study completion (Day 60)|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization. Here, number analyzed are the participants who were evaluable for this outcome measure.|||log10 (vp/mL x hour).||Standard Deviation|Mean
2589396|NCT02293863|Secondary|Percentage of Participants Who Died Due to Any Cause||Days 14, 30 and 60|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization.|||percentage of participants||80% Confidence Interval|Number
2589397|NCT02293863|Secondary|Percentage of Participants With Clinical Resolution of Abnormal Vital Signs|Description: Clinical resolution of abnormal vital signs was defined as meeting three out of five of the following criteria: 1. SpO2 ≥ 95% without supplemental O2; 2. Respiratory rate < 24 breaths per minute without supplemental O2; 3. Core temperature < 37.2 Celsius (C) immediately prior to receipt of any antipyretic drug, and at least 6-8 hours from the last dose of antipyretic or core temperature > 36 C in participants who are initially hypothermic; 4. Heart rate (HR) < 100 beats/minute; 5. Systolic blood pressure (SBP) >90 mmHg. Reported here is the percentage of participants who had clinical resolution of at least three out of five abnormal vital signs by the end of study.|From randomization up to 60 days|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization.|||percentage of participants||80% Confidence Interval|Number
2589398|NCT02293863|Secondary|Percentage of Participants With Clinical Failure|Clinical failure after 24 hours post-infusion of study drug was defined as progression to increased O2 requirement defined by an increase in oxygen supplementation from low flow oxygen (i.e., 2−6 liters per minute [L/min]) to high flow oxygen (i.e., > 6 L/min) or from oxygen supplementation alone to any positive pressure ventilation (PPV) or extracorporeal membrane oxygenation (ECMO), progression to ICU, prolonged ventilation or O2 support defined by > 2 weeks, or death.|24 hours after end of infusion (infusion duration = approximately 120 minutes) up to Day 60|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization.|||percentage of participants||80% Confidence Interval|Number
2589399|NCT02293863|Secondary|Percentage of Participants by Clinical Status Using a Categorical Ordinal Outcome|The clinical status of participants was defined by five mutually exclusive categories: 1. Death; 2. In the Intensive Care Unit (ICU); 3. Non-ICU hospitalization, requiring supplemental oxygen (O2); 4. Non-ICU hospitalization, not requiring supplemental oxygen (O2); 5. Not hospitalized.|Days 1-7, 14 and 30|ITTi population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization.|||percentage of participants|||Number
2589400|NCT02293863|Primary|Time to Normalization of Respiratory Function|The time to normalization of respiratory function was defined as the time to removal of the participant from oxygen (O2) supplementation in order to maintain a blood oxygen saturation level (SpO2) equal to or greater than 95% as measured by pulse oximetry.|From randomization up to 60 days|Intent-to-treat infected (ITTi) population included all randomized participants who were confirmed to be influenza A infected, with participants grouped according to the treatment assigned at randomization.|||days||80% Confidence Interval|Median
2589401|NCT02293863|Primary|Number of Participants With Anti-Therapeutic Antibodies (ATA) to MHAA4549A During and Following Administration of MHAA4549A|Reported are the number of participants positive for ATAs at baseline, the number of participants with treatment-induced ATAs and the number of participants with treatment-enhanced ATAs.|From randomization up to 60 days|Safety Population included all randomized participants who received study drug, with participants grouped according to the treatment actually received. Here, number analyzed are the participants who were evaluable for this outcome measure.|||participants|||Number
2589402|NCT02293863|Primary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|From randomization up to 60 days|Safety Population included all randomized participants who received study drug, with participants grouped according to the treatment actually received.|||percentage of participants|||Number
2589403|NCT02293798|Primary|Number of Participants With Areolar Dilation of up to 6mm at 12 Months|areolar dilation of up to 6mm|12 months after SERI implantation||||Participants|||Count of Participants
2589404|NCT02293538|Secondary|Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 14|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The anterior-most layer of the pre-lens tear film consists of lipids. Lipid layer thickness (LLT) is measured with the LipiView® Interferometer. LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness. Higher values of LLT indicate a better lubrication of the ocular surface. A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film. The right eye only was used for this measure.|Day 14, after 2 hours of lens wear|Intention to treat participants with non-missing observations|||ICU||Standard Deviation|Mean
2589405|NCT02293538|Secondary|Mean Change From Baseline in Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) to Day 14|At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time. Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day. Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion. A positive change from Baseline indicates improvement. The participant rated both eyes together by providing one single rating.|Baseline (Day 0), Day 14|Intention to treat participants with non-missing observations|||hours||Standard Deviation|Mean
2589406|NCT02293538|Secondary|Percentage of Participants That Experienced At Least 1 Unit Increase From Baseline Score to Day 14 for Overall Comfort With Lenses|Overall comfort was rated by the participant on a 10-point scale, where 1=Poor and 10=Excellent, at Day 0 for their habitual lenses and at Day 14 for the lenses worn for the study during use of the assigned drop regimen. A 1-unit increase indicates improvement. The participant rated both eyes together by providing one single rating.|Baseline (Day 0), Day 14|Intention to treat participants with non-missing observations|||percentage of participants|||Number
2589407|NCT02293538|Secondary|Mean Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) at Baseline and Day 14|At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time. Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day. Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion. The participant rated both eyes together by providing one single rating. This outcome measure was prespecified for only FID 114657.|Baseline (Day 0), Day 14|Intention to treat participants with non-missing observations|||hours||Standard Deviation|Mean
2589418|NCT02292927|Primary|Change From Baseline in Metabolic Equivalents (METS) at Six Weeks|"• Metabolic equivalent level is a measure of physical fitness. One MET is defined as 3.5 mL 02 uptake/kg per minute which is the resting oxygen uptake in a sitting position. The achieved exercise capacity in METs has been shown to be predictive in older adult population of survival with higher MET levels associated with improved survival, or similar definition that is accurate and appropriate."|Collected at baseline and (expected) 6 weeks|There were no patients in the pre-intervention group who underwent pre-operative METS testing|||METS||Full Range|Mean
2589408|NCT02293538|Primary|Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 1|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The anterior-most layer of the pre-lens tear film consists of lipids. Lipid layer thickness (LLT) is measured with the LipiView® Interferometer. LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness. Higher values of LLT indicate a better lubrication of the ocular surface. A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film. The right eye only was used for this measure.|Day 1, after 2 hours of lens wear|Intention to treat participants with non-missing observations|||ICU||Standard Deviation|Mean
2589409|NCT02293512|Primary|Coping|"The Brief COPE scale (Carver, 1997) is a widely-used 28-item short form of the COPE Inventory (Carver, Scheier et al., 1989). This instrument measures 14 coping subscales. Each item is scored using a 1-4 frequency scale (i.e., 1= I haven't been doing this it at all to 4= I've been doing this a lot), where higher scores reflect greater use of the coping strategy. A three-factor structure was used as follows: (a) Engagement coping (EC), including active coping, positive reframing, planning, accepting, and use of humor (items n = 12; score range 12-48); (b) disengagement coping (DC), including self-distancing, denial, behavioral disengagement, and self-blame (items n = 6; score range 6-24); and (c) social support coping (SS), including instrumenal support, emotional support, venting, and religion (items n = 8; score range 8-32)."|Baseline|Brief COPE 3 factors (engagement, disengagement, and social support)|||units on a scale||Standard Deviation|Mean
2589410|NCT02293460|Primary|Efficacy Endpoint: Responder Rate at End of Study|"Responders were defined as patients with a decrease ≥1 point in the adjusted INCAT disability score compared to baseline. Adjusted INCAT disability score can vary from 0 (normal) to 9 (maximal disability).~If a patient was treated with a not-allowed treatment during the study period, then all adjusted INCAT disability score measured after the intake of these not-allowed treatments were censored.~If the score at EoS visit was missing, then the Last Observation Carried Forward (LOCF) approach was applied to replace this missing value."|24 weeks after first treament injection||||Participants|||Count of Participants
2589411|NCT02293395|Primary|Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events|Non CABG-related TIMI clinically significant bleeding events are sum of non CABG-related TIMI major bleeding events, TIMI minor bleeding events and TIMI bleeding events requiring medical attention. Major: any symptomatic intracranial bleeding: clinically overt signs of hemorrhage with hemoglobin (Hb) drop of greater than or equal to (>=)5 gram per deciliter (g/dl) (or absolute drop in hematocrit of >=15%) and fatal bleeding (results in death within 7 days); Minor: clinically overt sign of hemorrhage with Hb drop of 3 - <5 g/dl (or drop in hematocrit of 9 - <15%); requiring medical attention: bleeding event that required medical, surgical treatment/laboratory evaluation and did not meet criteria for major/minor bleeding event.|From start of study treatment until follow-up (up to 390 days)|Population analyzed included all randomized participants who had received at least one dose of study agent and had events that occurred between randomization and the last dose of the study agent plus 2 days or untreated participants who had events that occurred between randomization to 2 days thereafter.|||participants|||Number
2589412|NCT02293044|Secondary|Change From Baseline Visual Analog Scale|Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline. The mean change from Baseline was calculated for this measure.|1 Day|Fifteen (15) subjects received study products. Fifteen (15) subjects completed the study.|||Units on a scale||Standard Deviation|Mean
2589413|NCT02293044|Primary|Change From Baseline Cold Water Challenge|The Schiff Sensitivity Scale was assessed for each test tooth via a cold water challenge. The examiner recorded the Schiff Index score corresponding to the response to the cold water challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline. The mean change from Baseline was calculated for this measure.|1 Day|Fifteen (15) subjects received study products. Fifteen (15) subjects completed the study.|||Units on a scale||Standard Deviation|Mean
2589414|NCT02292927|Secondary|LOS|Length of hospital stay after aortic surgery (number of days) - Observation to power a larger intervention study|Collected at (expected) 6 weeks +hospital stay|The number of participants where length of hospital stay information was available was significantly reduced as this information was not collected by the study reporting team.|||days||Full Range|Mean
2589415|NCT02292927|Secondary|HDU/ITU Resource Use (Number of Days Stay)|Observation to power a larger intervention study|Collected at (expected) 6 weeks +hospital stay|The number of participants where post operative HDU/ITU stay information was available was significantly reduced as this information was not collected by the study reporting team.|||Days||Full Range|Mean
2589416|NCT02292927|Primary|Number of Participants With Attendance at the Physical and Psychological and Social Training Appointments of the Rehabilitation Programme (Assessed by Bespoke Questionnaire)||Collected at baseline and during the study||||Participants|||Count of Participants
2589417|NCT02292927|Primary|Decrease in Anxiety and Depression Scores (Hospital Anxiety and Depression Scale)|HADS is a validated questionnaire consisting of 7 statements relating to anxiety and 7 statements relating to depression. Each statement is scored between 0 and 3 giving a total score of up to 21 for each section. A score of 0-7 is assumed to be normal and score greater than this suggestive of a mood disorder|Collected at baseline and (expected) 6 weeks|There were no patients in the pre-intervention group who underwent pre-operative HADS testing|||HADS scores||Full Range|Mean
2589419|NCT02292927|Primary|The Number of Patients Who Accepted Inclusion Into a Pre-operative Prehabilitation Programme|This describes the number of people within the study who were in the pre-habilitation study arm that accepted and completed the pre-habilitation training|Collected at screening||||participants|||Number
2590954|NCT02277665|Primary|Tobacco Abstinence|the percent of participants who achieve sustained tobacco abstinence, which reflects biologically-verified abstinence during weeks 5-12|Weeks 9-12||||Participants|||Count of Participants
2589422|NCT02292849|Primary|Proportion of Peer to Peer Coaches Who Undergo Behavioral Activation Training and Achieve Certification|Proportion of Peer to Peer coaches who undergo Behavioral Activation training and achieve certification|4 weeks prior to Baseline|This outcome analyzed Peer to Peer coaches who were eligible to provide the Behavioral Activation intervention|||Participants|||Count of Participants
2589423|NCT02292771|Secondary|Volume of Distribution of Retosiban|Maternal blood samples were collected at the indicated time points for pharmacokinetic analysis. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).|Day 1 (2 to 4 hours, 10 to 14 hours) and Day 2 (22 to 26 hours, and 48 to 54 hours) post-infusion|Maternal Safety Population. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).|||Liters||Geometric Coefficient of Variation|Geometric Mean
2589424|NCT02292771|Secondary|Retosiban Clearance|Maternal blood samples were collected at the indicated time points for pharmacokinetic analysis. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).|Day 1 (2 to 4 hours, 10 to 14 hours) and Day 2 (22 to 26 hours, and 48 to 54 hours) post-infusion|Maternal Safety Population. Data is a combined data set. Data is presented for 10 participants from retosiban arm of study 200719 (NCT02377466) and 43 participants from retosiban arm of study 200721 (NCT02292771).|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2589425|NCT02292771|Secondary|Number of Participants Admitted to Particular Hospital Unit|Maternal healthcare resource utilization associated with an episode of preterm labor and normal term delivery were collected from the review of medical records. The number of participants who were admitted to a particular hospital unit like general ward, private/semi-private room, recovery, and other has been presented.|Up to 28 days post EDD (40 0/7 weeks gestation)|Maternal Safety Population|||Participants|||Number
2589426|NCT02292771|Secondary|Maternal Length of Stay in Hospital|The length of hospital stay associated with hospital admission for preterm labor and term labor/term delivery was collected from review of medical records. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to 28 days post EDD (40 0/7 weeks gestation)|Maternal Safety Population|||Days||Full Range|Median
2589427|NCT02292771|Secondary|Number of Neonatal Participants With DRE|The disease related neonatal events occurring in Infants born prior to 37 completed weeks included: apnea (severe), respiratory failure due to fatigue, hypoxia, or air leak from alveolar injury, patent ductus arteriosus, bradycardia, ventriculomegaly, cerebellar hemorrhage, hydrocephalus other than congenital, gastroesophageal reflux, aspiration pneumonia, anemia, retinopathy of prematurity (all stages), hearing disorder, temperature instability and hypoglycemia. The number of participants with at least one DRE has been presented.|Up to 28 days after EDD of 40 weeks gestation|Neonatal Safety Population|||Participants|||Number
2589428|NCT02292771|Secondary|Number of Neonatal Participants With AESI|Neonatal AESI included: Neonatal death; Asphyxia; Infections (early onset neonatal sepsis, septic shock, pneumonia, meningitis); RDS; Hypotension; IVH/periventricular leukomalacia; Bronchopulmonary dysplasia; Neonatal acidosis; Hyperbilirubinemia; Necrotizing enterocolitis; and Hypoxic ischemic encephalopathy. The number of neonatal participants who experienced at least one AESI has been presented.|Up to 28 days after EDD of 40 weeks gestation|Neonatal Safety Population|||Participants|||Number
2589429|NCT02292771|Secondary|Number of Neonatal Participants With Non-serious AEs and SAEs|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. The number of participants who experienced at least one non-serious AE and one SAE has been presented. Neonatal Safety Population consisted of neonates whose mothers received randomized treatment.|Up to 28 days after the EDD of 40 weeks gestation|Neonatal Safety Population|||Participants|||Number
2589430|NCT02292771|Secondary|Head Circumference of Neonates|The head circumference was determined from the neonate birth record. Only those participants with data available at the specified data points were analyzed.|Up to 17 weeks|Neonatal ITT Population|||centimeters (cm)||Standard Deviation|Mean
2589431|NCT02292771|Secondary|Weight of Neonates|The weight of neonates was obtained from the neonate birth record. The mean weight of neonates and standard deviation has been presented. Only those participants with data available at the specified data points were analyzed.|Up to 17 weeks|Neonatal ITT Population|||grams (g)||Standard Deviation|Mean
2589432|NCT02292771|Secondary|Neonatal APGAR Scores|APGAR is a quick test to assess the health of new born children. The test is performed at 1 and 5 minutes after birth. APGAR scale is determined by evaluating the new born on five categories (appearance, pulse, grimace, activity and respiration) on a scale from zero to two, then summing up the five values obtained. APGAR score ranges from 0 to 10 where a score of 7 and above is normal. The mean and standard deviation of APGAR scores at one minute and at five minutes of birth has been presented.Only those participants with data available at the specified data points were analyzed.|Up to 5 minutes after birth|Neonatal ITT Population|||Score on APGAR scale||Standard Deviation|Mean
2589433|NCT02292771|Secondary|Number of Participants With Fetal AESI|Fetal AESI included: intrauterine fetal demise; category II or III fetal heart rate tracing; and fetal inflammatory response syndrome characterized by cord blood interleukin-6 >11 picogram per milliliter (pg/mL), funisitis, or chorionic vasculitis. The number of participants who experienced at least one AESI has been presented.|Up to 17 weeks|Maternal Safety Population|||Participants|||Number
2589480|NCT02292537|Secondary|Number of Participants Taking Any Concomitant Medication Related to Dosing Procedure or Sham Procedure|Concomitant medications include prescription and over-the-counter medications administered to participants on or after the first day of study treatment.|Baseline through Month 15|Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure.|||participants|||Number
2590955|NCT02277665|Primary|Tobacco Quit Attempts|Percent of Participants who made at least one tobacco quit attempt|Week 12||||Participants|||Count of Participants
2589434|NCT02292771|Secondary|Number of Participants With Fetal Non-serious AEs and SAEs|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. The number of participants who experienced at least one non-serious AE and one SAE has been presented.|Up to 17 weeks|Maternal Safety Population|||Participants|||Number
2589435|NCT02292771|Secondary|Number of Maternal Participants With Disease Related AEs (DRE)|Maternal DREs included: signs and symptoms of labor discomfort (example, cramping, backache, muscle aches, nausea); subsequent episodes of preterm labor and hospitalization for delivery. The number of participants with at least one DRE has been presented.|Up to 6 weeks post-delivery|Maternal Safety Population|||Participants|||Number
2589436|NCT02292771|Secondary|Number of Maternal Participants With AEs of Special Interest (AESI)|Maternal AESI included: maternal death; chorioamnionitis and its complications (clinical chorioamnionitis, preterm premature rupture of membranes, endomyometritis, wound infection, pelvic abscess, bacteremia, septic shock, disseminated intravascular coagulation, and adult RDS); placental abruption; postpartum hemorrhage - postpartum hemorrhage and/or retained placenta and pulmonary edema. The number of participants with at least one AESI has been presented.|Up to 6 weeks post-delivery|Maternal Safety Population|||Participants|||Number
2589437|NCT02292771|Secondary|Change From Baseline in Direct Bilirubin, Bilirubin, Indirect Bilirubin, Creatinine and Urate Levels in Maternal Participants|Blood samples were collected for the evaluation of change from Baseline in levels of direct bilirubin, bilirubin, indirect bilirubin, creatinine and urate. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 1 week|Maternal Safety Population|||micromoles per liter (µmol/L)||Standard Deviation|Mean
2589438|NCT02292771|Secondary|Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Magnesium, Phosphate and Sodium Level in Maternal Participants|Blood samples were collected for the evaluation of change from Baseline in levels of calcium, chloride, carbon dioxide, glucose, potassium, magnesium, phosphate, and sodium. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 1 week|Maternal Safety Population|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2589439|NCT02292771|Secondary|Change From Baseline in Albumin and Protein Levels in Maternal Participants|Blood samples were collected for the evaluation of change in albumin and protein levels from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 1 week|Maternal Safety Population|||grams per liter (g/L)||Standard Deviation|Mean
2589440|NCT02292771|Secondary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) Levels in Maternal Participants|Blood samples were collected for the evaluation of change in ALP, ALT, AST, GGT and LDH from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 1 week|Maternal Safety Population|||International Units per liter (IU/L)||Standard Deviation|Mean
2589441|NCT02292771|Secondary|Change From Baseline in Erythrocyte Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) in Maternal Participants|Blood samples were collected for the evaluation of change in MCV and MPV from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 1 week|Maternal Safety Population|||femtoliter (fL)||Standard Deviation|Mean
2589442|NCT02292771|Secondary|Change From Baseline in Hemoglobin and Erythrocyte Mean Corpuscular Hemoglobin Concentration (MCHC) in Maternal Participants|Blood samples were collected for the evaluation of change in hemoglobin levels and MCHC from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus. NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 1 week|Maternal Safety Population|||grams per liter (g/L)||Standard Deviation|Mean
2589443|NCT02292771|Secondary|Change From Baseline in Erythrocytes in Maternal Participants|Blood samples were collected for the evaluation of change in erythrocytes from Baseline. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 1 week|Maternal Safety Population|||Trillion cells per liter||Standard Deviation|Mean
2589481|NCT02292537|Secondary|Number of Participants With Abnormal, Clinically Relevant Post-Baseline Worsening in Electrocardiogram (ECG) in Results|The number of participants with abnormal, clinically relevant worsening, defined as participants with an ECG interpreted as abnormal and clinically relevant, with a comparison with Baseline value is reported.|Baseline through Month 15|Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure.|||participants|||Number
2589444|NCT02292771|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Count in Maternal Participants|Blood samples were collected for the evaluation of change in basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes count. Baseline is defined as the last available assessment prior to the first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). NA indicates standard deviation was not calculable for a single data point.|Baseline and up to 1 week|Maternal Safety Population|||Billion cells per liter (L)||Standard Deviation|Mean
2589445|NCT02292771|Secondary|Change From Baseline in Temperature in Maternal Participants|Temperature was measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||degree Celsius||Standard Deviation|Mean
2589446|NCT02292771|Secondary|Change From Baseline in Respiratory Rate in Maternal Participants|Respiratory rate was measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||breaths per minute||Standard Deviation|Mean
2589447|NCT02292771|Secondary|Change From Baseline in Heart Rate in Maternal Participants|Heart rate was measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||Beats per minute||Standard Deviation|Mean
2589448|NCT02292771|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) in Maternal Participants|SBP and DBP were measured during inpatient randomized treatment phase (15 to 30 minutes, 4 to 8 hours, and 20 to 24 hours after the start of the infusion, at the end of the infusion) and at the post-infusion assessment. Baseline is the last available assessment prior to first dose of study treatment. Change from Baseline is the post-dose visit value minus Baseline. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to 1 week|Maternal Safety Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2589449|NCT02292771|Secondary|Number of Maternal Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the other outcomes described before; is associated with liver injury and impaired liver function. Maternal Safety Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment. The number of maternal participants who experienced at least one non-serious AE and one SAE has been presented.|Up to 6 weeks after delivery|Maternal Safety Population|||Participants|||Number
2589450|NCT02292771|Secondary|Number of Participants With Births <=24 Hours From the First Study Treatment|Number of participants who delivered in less than or equal to 24 hours from first dose of study treatment has been presented.|Up to 24 hours|Maternal ITT Population|||Participants|||Number
2589451|NCT02292771|Secondary|Number of Participants With Births <=48 Hours From the First Study Treatment|Number of participants who delivered in less than or equal to 48 hours from first dose of study treatment has been presented.|Up to 48 hours|Maternal ITT Population|||Participants|||Number
2589452|NCT02292771|Secondary|Number of Participants With Births <=7 Days From the First Study Treatment|Number of participants who delivered in less than or equal to 7 days from first dose of study treatment has been presented.|Up to 7 days|Maternal ITT Population|||Participants|||Number
2589453|NCT02292771|Secondary|Number of Participants With Births Prior to 35 0/7 Weeks Gestation|Number of participants who delivered prior to 35 0/7 weeks gestation has been presented. Only those maternal participants who were randomized prior to 35 0/7 week's gestation and delivered were included.|Up to 11 weeks|Maternal ITT Population|||Participants|||Number
2589454|NCT02292771|Secondary|Number of Participants With Births Prior to 32 0/7 Weeks Gestation|Number of participants who delivered prior to 32 0/7 weeks gestation has been presented. Only those maternal participants who were randomized prior to 32 0/7 week's gestation and delivered were included.|Up to 8 weeks|Maternal ITT Population|||Participants|||Number
2589455|NCT02292771|Secondary|Number of Participants With Births Prior to 28 0/7 Weeks Gestation|The number of participants who delivered prior to 28 0/7 weeks gestation has been presented. Only those maternal participants who were randomized prior to 28 0/7 week's gestation and delivered were included.|Up to 4 weeks|Maternal ITT Population|||Participants|||Number
2589456|NCT02292771|Secondary|Number of Newborn Participants With Hospital Readmission|Newborn hospital readmission following hospitalization for birth was obtained from the newborn's medical records. Only those participants with data available at the specified data points were analyzed.|Up to 28 days of EDD (40 0/7 weeks gestation)|Neonatal Safety Population|||Participants|||Number
2589457|NCT02292771|Secondary|Length of Stay in Specialized Care Unit|Length of neonatal stay in specialized care unit like Intensive Care Unit (ICU) or Neonatal Intensive Care Unit (NICU) are reported.|Up to 28 days post EDD (40 0/7 weeks gestation)|Neonatal Safety Population|||Days||Full Range|Median
2602927|NCT02137512|Other Pre-specified|Episodes of Diabetic Ketoacidosis (DKA) Events - Extension Phase|Episodes of DKA events that occurred during the 5-month extension phase|5 months||||events|||Number
2589458|NCT02292771|Secondary|Number of Neonates With Each Individual Component of Composite Neonatal Morbidity and Mortality|The neonatal composite endpoint was determined from review of medical records and included the following components: fetal or neonatal death, RDS, BPD, NEC or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, ROP, IVH, cerebellar hemorrhage and white matter injury included Periventricular Leukomalacia PVL), porencephalic cyst, and persistent ventriculomegaly. Number of neonates with with each individual component of the composite neonatal morbidity and mortality has been presented.|Up to 28 weeks after EDD (40 weeks gestation)|Neonatal ITT Population|||Participants|||Number
2589459|NCT02292771|Secondary|Number of Neonates With Any Composite Neonatal Morbidity and Mortality, Excluding RDS|The neonatal composite endpoint was determined from review of medical records and included the following components: fetal or neonatal death, RDS, BPD, NEC or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, ROP, IVH, white matter injury and cerebellar hemorrhage. Number of neonates with any composite neonatal morbidity and mortality component, excluding RDS has been presented.|Up to 28 weeks after EDD (40 weeks gestation)|Neonatal ITT Population|||Participants|||Number
2589460|NCT02292771|Secondary|Number of Neonates With Composite Neonatal Morbidity and Mortality|The neonatal composite endpoint was determined from review of medical records and included the following components: fetal or neonatal death, Respiratory Distress Syndrome (RDS), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC) or isolated perforation, sepsis based on positive blood culture with clinical features of sepsis, meningitis based on positive results for cerebrospinal fluid culture performed as part of infection workup, retinopathy of prematurity (ROP), Intraventricular Hemorrhage (IVH), white matter injury and cerebellar hemorrhage.|Up to 28 weeks after EDD (40 weeks gestation)|Neonatal ITT Population|||Participants|||Number
2589461|NCT02292771|Secondary|Length of Neonatal Hospital Stay|The length of stay was collected from medical records and was calculated as the days between the delivery date and time and discharge date and time. Log of length of stay was calculated as treatment plus GA at randomization plus established progesterone use based on Analysis of covariance (ANCOVA) model. The p-value was calculated using t-test method. Neonatal ITT Population comprised of all neonates whose mothers were the randomized participants who have been exposed to study treatment, that is, mothers from the ITT Population.|Up to 28 days post estimated date of delivery (EDD) of 40 0/7 weeks gestation|Neonatal ITT Population|||Days||95% Confidence Interval|Least Squares Mean
2589462|NCT02292771|Secondary|Number of Participants With Births at Term|Participants were considered to have delivered at term if the gestational age was >=37 0/7. The number of participants who delivered at term, that is, 37 0/7 to 41 6/7 weeks gestation has been presented. Logistic regression model was used to calculate p-values.|Up to 17 weeks|Maternal ITT Population|||Participants|||Number
2589463|NCT02292771|Secondary|Number of Participants With Births Prior to 37 0/7 Weeks Gestation|Gestational age (GA) at birth (weeks) is defined as the GA when the baby is born. Participants were considered to have delivered prior to 37 0/7 weeks, that is preterm , if the GA at birth is less than 37 0/7 weeks. The number of participants who delivered prior to 37 0/7 weeks gestation has been presented. Logistic regression model was used to calculate p-values.|Up to 13 weeks|Maternal ITT Population|||Participants|||Number
2589464|NCT02292771|Primary|Time to Delivery From the Start of Investigational Product (IP) Administration|Time to delivery is the number of days from the first dose of study treatment until delivery. The time to delivery was calculated as the days between the delivery and start time of the study treatment infusion using the formula: Time to delivery (days) = (date and time of delivery minus date and time of start of infusion) divided by (24 multiplied by 60). The adjusted mean number of days to delivery along with standard error has been presented. Maternal intent-to-treat (ITT) Population comprised of all mothers randomly assigned to treatment who have been exposed to study treatment irrespective of their compliance to the planned course of treatment.|Up to 17 weeks|Maternal ITT Population|||Days||Standard Error|Mean
2589465|NCT02292758|Other Pre-specified|Dynamic Change in Mutation Concentration While the Patient is Receiving Cetuximab Treatment|Scatter plots and box plots will be used to illustrate such change.|Baseline up to 2 years|||||||
2589466|NCT02292758|Other Pre-specified|Change in Genotype Concentrations of Prespecified Gene Mutations in Circulating Cell-free Deoxyribonucleic Acid (DNA) (cfDNA)|The mean and median change in mutation concentration for each prespecified gene, and provide the corresponding 95% confidence intervals will be estimated. Cox proportional hazards models will be applied to explore the predictive value of pretreatment mutation status for cetuximab sensitivity and resistance, using PFS and OS as the outcome variables.|Baseline up to 2 years|||||||
2589467|NCT02292758|Secondary|Relative Dose Intensity (RDI)|RDI is defined as the total dose of protocol therapy a patient actually received (i.e., summation of actually received dose at each cycle) divided by the total planned dose (i.e., summation of planned dose level at each cycle) multiplied by 100. Separate RDIs will be calculated for irinotecan and cetuximab. Agent-specific RDI will be summarized by medians, and min and max values, all of which will be compared between the two treatment groups by the Wilcoxon Rank sum test.|Up to 2 years||||percentage of dose received||Full Range|Median
2589468|NCT02292758|Secondary|Percentage of Participants With Treatment Failure at 6 Months|TTF is defined as the time from the date of randomization to the date of treatment discontinuation due to PD, death, or severe AE. The distribution of TTF by treatment group will be estimated using the method of Kaplan-Meier. Six month event-free rates by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The HR with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors. PD: Any new lesion or increase by ≥50% of previously involved sites from nadir|assessed at 6 months||||percentage of participants||95% Confidence Interval|Number
2589482|NCT02292537|Secondary|Number of Participants With Clinically Significant Laboratory Parameter Abnormalities|Laboratory parameter changes assessed for clinical significance include serum chemistry, hematology, coagulation and urinalysis.|Baseline through Month 15|Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Any new or worsening clinical laboratory parameter findings were reported as AEs and are presented in the AE/SAE section of the results.|||participants|||Number
2589469|NCT02292758|Secondary|Duration of Response (DOR)|The distribution of DOR by treatment group will be estimated using the method of Kaplan-Meier. Six and 12 month durable response (i.e. maintaining CR or PR without progressive disease [PD]) rates by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The HR with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors.CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir|From the date of first tumor assessment with the response status being CR or PR to the date of 1st documented progressive disease, assessed up to 12 months|Participants who responded to treatment (CR or PR) are included in this analysis.|||months||95% Confidence Interval|Median
2589470|NCT02292758|Secondary|Overall Response Rate (ORR)|The response rate (percentage) is the percent of participants whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients. Response rates (including complete and partial response) will be tested using Fisher's exact test. CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites|Up to 2 years||||percentage of participants|||Number
2589471|NCT02292758|Secondary|Disease Control Rate (DCR)|Disease control is defined as maintaining Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) as the tumor assessment result during the defined time window. DCR (percentage) is defined as number of patients with success of disease control divided by total number of patients in the analysis population multiplied by 100, excluding patients who refuse treatment before the initiation of any treatment. CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir, SD: Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the MSD|Up to 2 years||||percentage of participants|||Number
2589472|NCT02292758|Secondary|12-month, 18-month, and 24-month Overall Survival (OS) Rates|The distribution of OS by group will be estimated using the method of Kaplan-Meier. Twelve, 18- and 24-month survival rates by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The HR with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors.|From randomization to the date of death due to any cause, assessed up to 24 months||||percentage of participants||95% Confidence Interval|Number
2589473|NCT02292758|Secondary|Overall Survival (OS)|The distribution of OS by group will be estimated using the method of Kaplan-Meier. Median OS by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The HR with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors.|From randomization to the date of death due to any cause, assessed up to 24 months||||months||95% Confidence Interval|Median
2589474|NCT02292758|Secondary|Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events|The number of participants who experienced at least one grade 3 or higher adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.|Up to 30 days from last dose of study treatment||||Participants|||Count of Participants
2589475|NCT02292758|Primary|6-month and 12-month Progression-free Survival (PFS) Rates|The distribution of PFS by group will be estimated using the method of Kaplan-Meier. Six and 12 month PFS rates by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The hazard ratio (HR) with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors. Progression (PD) is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD: Any new lesion or increase by ≥50% of previously involved sites from nadir).|From the date of randomization to the date of 1st documented disease progression or death due to any cause, whichever occurs first, assessed up to 24 months||||percentage of participants||95% Confidence Interval|Number
2589476|NCT02292758|Primary|Progression-Free Survival (PFS)|The distribution of PFS by group will be estimated using the method of Kaplan-Meier. Median by treatment group with confidence intervals will be estimated based on Kaplan-Meier curves. The hazard ratio (HR) with confidence interval will be estimated based on stratified Cox models (stratified by levels of stratification factors), without and with adjusting for baseline clinical/pathological factors. Progression (PD) is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD: Any new lesion or increase by ≥50% of previously involved sites from nadir).|From the date of randomization to the date of 1st documented disease progression or death due to any cause, whichever occurs first, assessed up to 24 months||||months||95% Confidence Interval|Median
2589477|NCT02292719|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|Up to 12 weeks after the last actual dose of active study drug|ITT population|||percentage of participants||95% Confidence Interval|Number
2589478|NCT02292719|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment for 12-week and 8-week treatment or at least 26 days of treatments for 6-week treatment.|Up to Week 12|ITT population|||percentage of participants||95% Confidence Interval|Number
2589479|NCT02292719|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|ITT population|||percentage of participants||95% Confidence Interval|Number
2589655|NCT02290613|Secondary|Mean Pulmonary Arterial Pressure During Exercise Change From Baseline|Determine whether exercise induced elevated mean pulmonary arterial pressure-values (>30 mmHg without left heart or severe lung disease or systemic arterial hypertension) can be reduced by ambrisentan 10 mg/die over 6 months.|baseline, 6 months||||mmHg||Standard Deviation|Mean
2589483|NCT02292537|Secondary|Number of Participants With Clinically Significant Physical Examination Abnormalities|Physical examination changes were assessed for clinical significance.|Baseline through Month 15|Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Physical examination clinical significance was not collected.||||||
2589484|NCT02292537|Secondary|Number of Participants With Clinically Significant Neurological Examination Abnormalities|Neurological changes assessed for clinical significance include assessment of mental status, level of consciousness, sensory function, motor function, cranial nerve function, and reflexes.|Baseline through Month 15|Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Neurological examination clinical significance was not collected.||||||
2589485|NCT02292537|Secondary|Number of Participants With Clinically Significant Weight Abnormalities|Weight changes assessed from Baseline to Month 15.|Baseline through Month 15|Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Any new or worsening weight abnormality findings were reported as AEs and are presented in the AE/SAE section of the results.|||participants|||Number
2589486|NCT02292537|Secondary|Number of Participants With Clinically Significant Vital Sign Abnormalities|Vital signs assessed for clinical significance include resting blood pressure, pulse, respiratory rate, and temperature.|Baseline through Month 15|Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Any new or worsening vital sign findings were reported as AEs and are presented in the AE/SAE section of the results.|||participants|||Number
2589487|NCT02292537|Secondary|Number of Participants That Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death; an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.|Baseline through Month 15|Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. All participants with AEs were reported in this outcome measure, whereas in Adverse Event section there was at 5% reporting threshold to be met.|||participants|||Number
2589488|NCT02292537|Secondary|Proportion of Participants That Achieved Walking With Assistance|If the participant was unable to achieve walking with assistance at baseline but could achieve this at Month 15 then they were considered a responder. If they could not achieve this or if a participant terminated the study prior to the 15-month assessment due to treatment failure or death, then any imputed value was ignored and the participant was considered as a non-responder.|Month 15|Efficacy Set: All participants with a Day 456 Visit and all participants with a time difference of at least 463 days (456 days plus a 7-day window) between the date of first dose and the date for the final analysis. Based on imputed data where there was missing data.|||Proportion of participants||95% Confidence Interval|Number
2589489|NCT02292537|Secondary|Proportion of Participants That Achieved Standing Alone|If the participant was unable to achieve standing alone at Baseline but could achieve this at Month 15 then they were considered a responder. If they could not achieve this or if a participant terminated the study prior to the 15-month assessment due to treatment failure or death, then any imputed value was ignored and the participant was considered as a non-responder.|Month 15|Efficacy Set: All participants with a Day 456 Visit and all participants with a time difference of at least 463 days (456 days plus a 7-day window) between the date of first dose and the date for the final analysis. Based on imputed data where there was missing data.|||Proportion of participants||95% Confidence Interval|Number
2589490|NCT02292537|Secondary|Change From Baseline in Revised Upper Limb Module (RULM) Test|The RULM Test is used in patients with SMA to assess upper limb functional ability items that are reflective of activities of daily living (i.e., raise a can to mouth as if drinking, take a coin and place it in a box, remove the lid of a container). The RULM test has a total of 20 items with an entry item that serves as functional class identification and does not contribute to the total score. The remaining 19 scorable items reflect different functional domains and are graded on a 3-point system with a score of 0 (unable), 1 (able, with modification), and a maximum of 2 (able, no difficulty). There is only 1 item (item I) that is scored as a can/cannot score, with 1 as the highest score. Scorable items are summed for a total score range of 0-37, with higher scores increased great upper limb function. A positive change from Baseline indicates improvement.|Baseline and Month 15|ITT Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Missing postbaseline data were imputed using multiple imputation.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2589491|NCT02292537|Secondary|Number of New Motor Milestones Achieved Per Participant|New motor milestones are defined as sitting without support, hands-and-knees crawling, standing with assistance, walking with assistance, standing alone and walking alone.|Month 15|Efficacy Set: All participants with a Day 456 Visit and all participants with a time difference of at least 463 days (456 days plus a 7-day window) between the date of first dose and the date for the final analysis. Based on imputed data where there was missing data.|||milestones achieved||Standard Deviation|Mean
2589492|NCT02292537|Secondary|Proportion of Participants That Achieved Any New Motor Milestone at Month 15|New motor milestones are defined as sitting without support, hands-and-knees crawling, standing with assistance, walking with assistance, standing alone and walking alone.|Month 15|Efficacy Set: All participants with a Day 456 Visit and all participants with a time difference of at least 463 days (456 days plus a 7-day window) between the date of first dose and the date for the final analysis. Based on imputed data where there was missing data.|||Proportion of participants||95% Confidence Interval|Number
2589569|NCT02291718|Secondary|Hounsfield Unit Attenuation Values|Grayscale values on CT scans are given as Hounsfield units. These Hounsfield units reflect the attenuation of x-ray beams traversing the aortic lumen. We will use Hounsfield units to assess whether the tool contrast agents achieve similar attenuation characteristics essential for diagnosing aortic abnormalities. We will use circular regions of interest in the thoracic aorta to extract the Hounsfield unit measurements.|30 minutes||||Hounsfield units||Standard Deviation|Mean
2589493|NCT02292537|Secondary|Proportion of Participants Who Achieved a 3-Point Increase From Baseline in HFMSE Score at Month 15|The HFMSE consists of 33 scored activities used to assess motor function in children with SMA. The scale was originally developed with 20 scored activities and was devised for use in children with SMA Type 2 and Type 3 with limited ambulation to give objective information on motor ability and clinical progression. The expanded scale includes an additional module of 13 items developed to allow for evaluation of ambulatory SMA patients. Participants were asked to do a specific activity (such as rolling) and they were then graded on the quality and execution of that movement on a scale of 0=being unable, 1=performed with some compensation, and 2=unaided. The overall score is the sum of the scores for all activities with a maximum achievable score of 66. Higher scores indicate increased motor function. A positive change from Baseline indicates improvement.|Baseline and Month 15|ITT Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Missing postbaseline HFMSE data were imputed using multiple imputation.|||Proportion of participants||95% Confidence Interval|Number
2589494|NCT02292537|Primary|Change From Baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE) Score at Month 15|The HFMSE consists of 33 scored activities used to assess motor function in children with SMA. The scale was originally developed with 20 scored activities and was devised for use in children with SMA Type 2 and Type 3 with limited ambulation to give objective information on motor ability and clinical progression. The expanded scale includes an additional module of 13 items developed to allow for evaluation of ambulatory SMA patients. Participants were asked to do a specific activity (such as rolling) and they were then graded on the quality and execution of that movement on a scale of 0=being unable, 1=performed with some compensation, and 2=unaided. The overall score is the sum of the scores for all activities with a maximum achievable score of 66. Higher scores indicate increased motor function. A positive change from Baseline indicates improvement.|Baseline and Month 15|ITT Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Missing postbaseline HFMSE data were imputed using the multiple imputation method.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2589495|NCT02292446|Secondary|Change From Baseline in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)|"The MPN-SAF (Appendix 6) was a disease specific questionnaire comprised of 10 items that measures fatigue related to MPN disease and the severity of nine of the most prevalent associated symptoms including: early satiety, abdominal discomfort, inactivity, concentration, night sweats, itching, bone pain, fever and weight loss. There were three recall periods used in this questionnaire, which were 24 hours for fatigue, the past week for symptoms of early satiety, abdominal discomfort, inactivity, concentration, night sweats, itching, bone pain and fever, and the past 6 months for weight loss, Each item was scored on a scale ranging from 0 (no fatigue/absent) to 10 (As bad as you can imagine/worst imaginable). The MPN-SAF TSS was computed as the average of the observed items multiplied by 10 to achieve a 0-to-100 scale.~The MPN-SAF TSS thus had a possible score range of 0 to 100."|Up to approximately 26 months|Number of participants qualifying for evaluation of change from baseline varied across visits|||scores||Standard Deviation|Mean
2589496|NCT02292446|Secondary|Change From Baseline in Spleen Length|Change in spleen length from Baseline to each visit|Up to approximately 26 months|Number of participants qualifying for evaluation of change from baseline varied across visits|||cm||Standard Deviation|Mean
2589497|NCT02292446|Secondary|Change From Baseline in Hematocrit Levels at All Visits|Change in hematocrit levels from Baseline to each visit were measured|Up to approximately 26 months|Number of participants qualifying for evaluation of change from baseline varied across visits|||percentage||Standard Deviation|Mean
2589498|NCT02292446|Primary|Number of Participants With Adverse Events - All Grades|Summary of adverse events (all grades).|Baseline up to approximately 26 months||||Participants|||Count of Participants
2589499|NCT02292433|Secondary|Change From Baseline in Pre-Meal C-Peptide at Day 7|Time-matched change from baseline in pre-meal serum C-peptide on Day 7 of each period was analyzed. Pre-meal C-peptide levels therefore, pre-breakfast, pre-lunch, and pre-dinner were analyzed.|Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7|PD analysis population included all randomized participants who received at least 1 dose of study medication and had both a baseline and a post-baseline assessment for at least 1 PD parameter in at least 1 period.|||ng/mL||Standard Deviation|Mean
2589500|NCT02292433|Secondary|Change From Baseline in Pre-Meal Insulin at Day 7|Time-matched change from baseline in pre-meal serum insulin on Day 7 of each period was analyzed. Pre-meal insulin levels therefore, pre-breakfast, pre-lunch, and pre-dinner were analyzed.|Pre-morning meal (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) after morning meal on Day 0 (Baseline); pre-morning dose (pre-breakfast), 5 hours (pre-lunch), 11 hours (pre-dinner) post-morning dose on Day 7|PD analysis population included all randomized participants who received at least 1 dose of study medication and had both a baseline and a post-baseline assessment for at least 1 PD parameter in at least 1 period.|||micro international unit per milliliter||Standard Deviation|Mean
2589501|NCT02292433|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Last Day of Treatment|FPG was defined as plasma glucose measurements taken pre-breakfast, in the fasted state, and prior to dosing with study drug. Baseline was defined as the average of Hour 0 measurements taken on Day 0 and Day 1 in each intervention period. The measurement on the last day of treatment was defined as the average of Hour 0 measurements taken on Day 7 and Day 8 in each period.|Pre-morning meal on Day 0, pre-morning dose on Day 1, pre-morning dose on Day 7, pre-morning meal on Day 8|PD analysis population included all randomized participants who received at least 1 dose of study medication and had both a baseline and a post-baseline assessment for at least 1 PD parameter in at least 1 period.|||mg/dL||Standard Deviation|Mean
2589502|NCT02292433|Secondary|Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 7|WMDG was defined as time-weighted mean daily glucose. WMDG was calculated by as the time-weighted mean of glucose levels at actual time points for glucose sampling, for Day 0 (Baseline) and Day 7.|Pre-morning meal, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16 and 20 hours post- morning meal on Day 0; pre-morning dose, 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20 hours post-morning dose on Day 7|The pharmacodynamic (PD) analysis population included all randomized participants who received at least 1 dose of study medication and had both a baseline and a post-baseline assessment for at least 1 PD parameter in at least 1 period.|||mg/dL||Standard Deviation|Mean
2589503|NCT02292433|Secondary|Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 7|MRAUC24 is the ratio of AUC24 of PF-06455349 (metabolite) to AUC24 of PF-04937319 (parent drug) * ratio of molecular weight of PF-04937319 to molecular weight of PF-06455349, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2589504|NCT02292433|Secondary|Accumulation Ratio (Rac) on Day 7 for PF-06455349|Rac is based on AUC24. It is the ratio of AUC24 of Day 7 and AUC24 of Day 1, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2589505|NCT02292433|Secondary|Terminal Half-Life (t1/2) on Day 7 for PF-06455349|Terminal half-life is the time measured for the plasma concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) * 2/k el, where 'k el' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||hour||Standard Deviation|Mean
2589506|NCT02292433|Secondary|Average Plasma Concentration (Cav) on Day 7 for PF--06455349|Cav is the average plasma concentration during the 0 to 24 hour time period. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2589507|NCT02292433|Secondary|Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF--06455349|Ctrough is the concentration prior to study drug administration. PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose) on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2589508|NCT02292433|Secondary|Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF--06455349|AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24). PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2589509|NCT02292433|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-06455349|PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||hour||Full Range|Median
2589510|NCT02292433|Secondary|Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF--06455349|PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2589511|NCT02292433|Secondary|Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 1|MRAUC24 is the ratio of AUC24 of PF-06455349 (metabolite) to AUC24 of PF-04937319 (parent drug) * ratio of molecular weight of PF-04937319 to molecular weight of PF-06455349, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2589512|NCT02292433|Secondary|Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF--06455349|AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24). PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2589513|NCT02292433|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-06455349|PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||hour||Full Range|Median
2589514|NCT02292433|Secondary|Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-06455349|PF-06455349 is a metabolite of PF-04937319.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2589515|NCT02292433|Primary|Accumulation Ratio (Rac) on Day 7 for PF-04937319|Rac is based on AUC24. It is the ratio of AUC24 of Day 7 and AUC24 of Day 1, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2589516|NCT02292433|Primary|Apparent Volume of Distribution on Day 7 for PF-04937319|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose is influenced by the oral bioavailability. It is calculated as the total oral daily dose divided by AUC24* k el, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours and terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||liter||Geometric Coefficient of Variation|Geometric Mean
2589517|NCT02292433|Primary|Terminal Half-Life (t1/2) on Day 7 for PF-04937319|Terminal half-life is the time measured for the plasma concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/k el, where 'k el' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||hour||Standard Deviation|Mean
2589518|NCT02292433|Primary|Apparent Oral Clearance on Day 7 for PF-04937319|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the oral bioavailability. It is calculated as the total oral daily dose divided by AUC24, where AUC24 is the area under the plasma concentration-time profile from time 0 to 24 hours.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
2589519|NCT02292433|Primary|Average Plasma Concentration (Cav) on Day 7 for PF-04937319|Cav is the average plasma concentration during the 0 to 24 hour time period.|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2589520|NCT02292433|Primary|Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF-04937319|Ctrough is the concentration prior to study drug administration.|0 hour (pre-dose) on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2589521|NCT02292433|Primary|Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF-04937319|AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2589522|NCT02292433|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-04937319||0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||hour||Full Range|Median
2589523|NCT02292433|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF-04937319||0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24, 36, 48 hours post morning dose on Day 7|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2589524|NCT02292433|Primary|Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF-04937319|AUC24 is the area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).|0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post-dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2589525|NCT02292433|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-04937319||0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||hour||Full Range|Median
2589526|NCT02292433|Primary|Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-04937319||0 hour (pre-dose), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 24 hours post morning dose on Day 1|Pharmacokinetic (PK) parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of PK parameters of interest calculated and available in at least 1 period.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2605739|NCT02107014|Primary|Change in MIP-1α From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2589527|NCT02292433|Primary|Number of Participants With Protocol Defined Hypoglycaemic Adverse Events (HAEs)|A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE was defined as 1 of the given definitions: 1) Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; 2) Characteristic symptoms of HAE with home glucose monitoring measurement of less than or equal to (=<) 70 milligram per deciliter (mg/dL) using sponsor-provided, plasma-referenced, home glucometers (or central laboratory); 3) any glucose value =<49 mg/dL using sponsor-provided, plasma-referenced, home glucometers (or central laboratory) with or without accompanying symptoms.|Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)|Safety analysis set included all participants who received at least 1 dose of study medication (including placebo) in at least 1 period.|||participants|||Number
2589528|NCT02292433|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 14 days after the last dose of study drug (minimum 8 weeks to maximum of 17 weeks)|Safety analysis set included all participants who received at least 1 dose of study medication (including placebo) in at least 1 period.|||participants|||Number
2589529|NCT02292212|Secondary|Device Malfunctions||Week 1 to 2 (Pre-ViE phase), 3 to 14 (ViE phase), and 15 to 16 (Post-ViE phase)|The safety analysis population (SAA) that is comprised of all patients that received at least one session with the ViE-21|||malfunctions|||Number
2589530|NCT02292212|Primary|Activated Complement Factor III (C3a )|Blood samples were obtained during the first week of dialysis with control dialyzer and then during weeks 7 and 13 with ViE-21. C3a was measured pre dialysis, at 15 minutes and post dialysis. The values were corrected with HCT and then leveled by defining the pre-dialysis value as 100%.|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.|||percentage of C3a level||Standard Deviation|Mean
2589531|NCT02292212|Primary|Platelet|Blood samples were obtained during the first week of dialysis with control dialyzer and then during weeks 7 and 13 with ViE-21. Platelet count was measured pre dialysis, at 15 minutes and post dialysis. The values were corrected with HCT and then leveled by defining the pre-dialysis value as 100%.|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.|||percentage of platelet level||Standard Deviation|Mean
2589532|NCT02292212|Primary|White Blood Cell (WBC)|Blood samples were obtained during the first week of dialysis with control dialyzer and then during weeks 7 and 13 with ViE-21. WBC count was measured pre dialysis, at 15 minutes and post dialysis. The values were corrected with HCT and then leveled by defining the pre-dialysis value as 100%.|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.|||percentage of WBC level||Standard Deviation|Mean
2589533|NCT02292212|Primary|Ultrafiltration Coefficient (KUF)|The KUF is important for regulating the rate and amount of fluid flow across the dialyzer membrane. It is calculated by dividing ultrafiltration rate with the transmembrane pressure (TMP). More specifically, transmembrane pressures were recorded at 10, 20, 30, 40 and 50 minutes after the initiation of the dialysis session with adjustment of the ultrafiltration rate at 0, 600, 1000, 1400 and 1800 mL/hr respectively. These determinations were made during the 2nd or 3rd treatment session during the 1st or 2nd week for control dialyzer (Pre-ViE phase), and for ViE-21 during week 3-8 and week 9-14 (ViE phase).|Week 1 or 2 (Pre-ViE phase), 3-8 and 9-14 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.|||mL/(hr*mmHg)||Standard Deviation|Mean
2589534|NCT02292212|Primary|Removal Rate of Beta-2-microglobulin (B2-MG)|"In order to calculate removal rate for B2-MG by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation.~Removal rate (%) = {1-[HCTpre*(1-HCTpost/100) * Cpost] / [HCTpost * (1-HCTpre/100) * Cpre]} * 100.~The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively."|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.|||percentage of B2MG removal||Standard Deviation|Mean
2589535|NCT02292212|Primary|Removal Rate of Albumin|"In order to calculate removal rate for albumin by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation with hematocrit (HCT) at pre (HCTpre) and post (HCTpost).~Removal rate (%) = {1-[HCTpre*(1-HCTpost/100) * Cpost] / [HCTpost * (1-HCTpre/100) * Cpre]} * 100.~The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively. The negative removal rate means the increase of serum concentration of albumin from pre to post dialysis session."|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.|||percentage of albumin removal||Standard Deviation|Mean
2589536|NCT02292212|Primary|Removal Rate of Creatinine|"In order to calculate removal rate for creatinine by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation.~Removal rate (%) = [(Cpre - Cpost) / (Cpre)] * 100. The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively."|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.|||percentage of creatinine removal||Standard Deviation|Mean
2589570|NCT02291718|Secondary|Signal to Noise Ratio|Calculated as the ratio of mean attenuation values divided by the standard deviation of attenuation values gathered using a circular region of interest in the thoracic aorta.|30 minutes|Hiatus region of each subject group|||Signal-to-Noise Ratio||Standard Deviation|Mean
2589571|NCT02291718|Primary|Radiation Dose||30 minutes||||mSv||Standard Deviation|Mean
2589537|NCT02292212|Primary|Removal Rate of Urea|"In order to calculate removal rate for urea by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation with Pre-dialysis concentration (Cpre) and Post-dialysis concentration (Cpost) of urea.~Removal rate (%) = [(Cpre - Cpost) / (Cpre)] * 100. The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively."|Week 1 (Pre-ViE phase), 7, 13 (ViE phase)|The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.|||percentage of urea removal||Standard Deviation|Mean
2589538|NCT02292186|Secondary|6-minute Walk Test Performance|Distance in meters walked in 6 minutes|Baseline, Month 6, and Month 12|Number of participants analyzed differs from baseline to 6 and 12 months due to study discontinuations|||meters||Standard Deviation|Mean
2589539|NCT02292186|Secondary|Clinical Effects of Long-term Dosing of ALN-TTRSC on Hospitalization|Hospitalization events were adjudicated by an independent committee as cardiovascular (CV) or non-CV events|Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 months||||Participants|||Count of Participants
2589540|NCT02292186|Secondary|Mortality|Total number of deaths in the study and total number of deaths adjudicated as being related to cardiovascular causes. Deaths were adjudicated by an independent adjudication committee as cardiovascular (CV) or non-CV events.|Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 months||||Participants|||Count of Participants
2589541|NCT02292186|Primary|Serum TTR Levels|Pharmacodynamic (PD) effect of long-term dosing of ALN-TTRSC on serum levels of TTR|Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 months|Long term samples not collected due to study termination; no data to analyze||||||
2589542|NCT02292186|Primary|Safety and Tolerability Results of Long-term Dosing With ALN-TTRSC (Revusiran) Transthyretin (TTR) Cardiac Amyloidosis Patients.|The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study [drug] discontinuation.|Day 0 up to 90 days post modified early termination visit (end of study); Mean duration of collection was 16 months||||Participants|||Count of Participants
2589543|NCT02292082|Secondary|Knee Society Score (KSS) at 6 Weeks Postoperatively|KSS (Knee Society Score) score measured at 6 weeks postoperatively. The scale is from 0-100. Scores below 60 indicate poor function, 60-69 indicate fair, 70-79 indicate good, and 80-100 indicate excellent functional scores. KSS measures knee pain, flexion contracture,extension lag, alignment, stability, and total range of flexion and generates an associated score correlating to knee function. Higher is better. There is no sub score - only the cumulative Knee Society Score.|Post operatively at approximately 6 weeks after surgery|Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)|||score on a scale||Standard Deviation|Mean
2589544|NCT02292082|Secondary|Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively|Painout most pain experienced 24-48 hours postoperatively measured on a scale from 0-10. Higher scores indicate higher pain levels.|24-48 hours postoperative|Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)|||score on a scale||Standard Deviation|Mean
2589545|NCT02292082|Secondary|Patient Outcome Questionnaire (painOUT) Most Pain for 0-24 Hours Postoperatively|Painout most pain experienced 0-24 hours postoperatively, measured from 0-10. 0 being no pain to 10 being the worst pain imaginable|0-24 hours postoperatively|Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)|||score on a scale||Standard Deviation|Mean
2589546|NCT02292082|Secondary|Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively|Least pain experienced from 24-48 hours postoperative on a scale from 0-10. 0 being no pain at all to 10 being the worst pain imaginable|24-48 hours postoperative|Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)|||score on a scale||Standard Deviation|Mean
2589547|NCT02292082|Secondary|Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively|Measures: least pain in the last 24 hours. Scores are measured from 0-10. 0 being no pain to 10 being the worst pain imaginable.|Participants will be followed for the duration of 2 days post operatively in the hospital|Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)|||score on a scale||Standard Deviation|Mean
2589548|NCT02292082|Secondary|Hospital Length of Stay|Measured in minutes.|Average of 3 days||||Minutes||Standard Deviation|Mean
2589549|NCT02292082|Secondary|Opioid Consumption POD2|Opioid consumption over hours 24-48 postoperatively. Measured in mg OME (oral morphine equivalents). Higher equates to more opioids consumed.|24-48 hours postoperative|Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)|||mg OME||Standard Deviation|Mean
2589550|NCT02292082|Secondary|Opioid Consumption Postoperative Day (POD) 1|Opioid consumption for patients from 0-24 hours postoperative, measured in mg OME (oral morphine equivalents)|0-24 hours postoperatively|Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)|||mg OME||Standard Deviation|Mean
2589551|NCT02292082|Secondary|NRS Pain Score With Movement POD2|NRS pain with movement as reported by the patient. Rated from 0-10. 0 being no pain, 10 being the worst pain imaginable.|48 hours after surgery|Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, discharge, logistical reasons)|||score on a scale||Standard Deviation|Mean
2589552|NCT02292082|Secondary|Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1|Patient reported pain scores on postoperative day 1 from 0-10. 0 being no pain, 10 being the worst pain imaginable.|24 hours after operating room discharge|Unable to gather outcome data from all patients due to various reasons (exclusions, withdrawals, logistical reasons)|||score on a scale||Standard Deviation|Mean
2589553|NCT02292082|Primary|Time to Meet Physical Therapy Discharge Criteria|Time to reach physical therapy (PT) goals|First 3 days post-operatively||||Minutes||Standard Deviation|Mean
2589738|NCT02290106|Secondary|Aspartate Aminotransferase (AST)|aspartate aminotransferase at 6 month timepoint|6 months|all patients with available data at baseline and final|||U/L||Standard Deviation|Mean
2589554|NCT02291913|Secondary|Median Overall Survival (OS)|Defined as the time from date of first study treatment to date of death due to any cause. Patients who are alive will be censored at the date of last known date alive.|up to 3 years from first treatment|Participants who received at least 1 cycle of study treatment and had at least one post-baseline radiologic assessment were evaluable for OS analysis per protocol. 36 of the total 48 patients were analyzed for OS. The remaining 12 treated patients did not meet this criteria to be analyzed.|||months||95% Confidence Interval|Median
2589555|NCT02291913|Secondary|Median Time From First Occurrence of CR or PR to Disease Progression or Death Also Called Duration of Response (DOR)|Only those patients who achieved Complete Response or Partial Response will be included in the summaries of DOR. DOR is defined as time from first date of response of CR or PR to disease progression or death as defined by RECIST v1.1 criteria. Participants who are alive and free from disease progression will be censored at the date of last tumor assessment. Patients who receive non-protocol therapy (subsequent therapy) prior to incurring an event will be censored at the date of last tumor assessment prior to the start of subsequent therapy. A CR is the complete disappearance of all target lesions. A PR is a decrease of 30% or more of the diameter(s) of all target lesions from the baseline sum of diameters.|every 8 weeks until discontinuation, up to 20 months|Only those patients who achieved Complete Response or Partial Response will be included in the summaries of DOR. A CR is the complete disappearance of all target lesions. A PR is a decrease of 30% or more of the diameter(s) of all target lesions from the baseline sum of diameters.|||months||95% Confidence Interval|Median
2589556|NCT02291913|Secondary|Number of Participants With CR, PR, or 6 Months of SD Also Called Clinical Benefit Rate (CBR)|The proportion of patients with Complete Response (CR) or Partial Response (PR) or 6 months or more of Stable Disease (SD). A CR is the complete disappearance of all target lesions. A PR is a decrease of 30% or more of the diameter(s) of all target lesions from the baseline sum of diameters. SD is not meeting the criteria for PR or a 20% increase in target lesions called Progressive Disease (PD).|Up to 20 months|Participants who received at least 1 cycle of study treatment and had at least one post-baseline radiologic assessment. 36 of the total 48 patients were analyzed for PFS. The remaining 12 treated patients did not meet this criteria to be analyzed.|||Participants|||Count of Participants
2589557|NCT02291913|Secondary|Number of Patients With an Objective Response (CR or PR) Also Called the Overall Response Rate (ORR).|Defined as the number of patients with objective evidence of complete or partial response (CR or PR) using RECIST version 1.1. A CR is the complete disappearance of all target lesions. A PR is a decrease of 30% or more of the diameter(s) of all target lesions from the baseline sum of diameters.|every 8 weeks until discontinuation, up to 20 months|Participants who received at least 1 cycle of study treatment and had at least one post-baseline radiologic assessment. 36 of the total 48 patients were analyzed for PFS. The remaining 12 treated patients did not meet this criteria to be analyzed.|||Participants|||Count of Participants
2589558|NCT02291913|Secondary|Number of Patients With Adverse Events (AEs) as a Measure of Safety and Tolerability|Assessments were made through analysis of the reported incidence of treatment-emergent AEs. All participants who received at least one dose of protocol treatment were followed for safety. Adverse events were collected from day of first dose to 30 days after last protocol treatment and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.|Up to 20 months|Number of participants who received at least one dose of study drug.|||Participants|||Count of Participants
2589559|NCT02291913|Primary|Median Progression Free Survival (PFS)|PFS is defined as the time from Day 1 of study drug administration to disease progression as defined by RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 criteria, or death on study. Participants who are alive and free from disease progression will be censored at the date of last radiologic tumor assessment. Participants who receive non-protocol therapy (subsequent therapy) prior to incurring an event will be censored at the date of last tumor assessment prior to the start of subsequent therapy. Participants who do not have a post-baseline tumor assessment will be censored at the date of first treatment (Day 1).|up to 3 years|Participants who received at least 1 cycle of study treatment and had at least one post-baseline radiologic assessment were evaluable for PFS analysis per protocol. 36 of the total 48 patients were analyzed for PFS. The remaining 12 treated patients did not meet this criteria to be analyzed.|||months||95% Confidence Interval|Median
2589560|NCT02291861|Secondary|Participants With Adverse Events During the Overall Treatment Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator and includes possibly, probably and definitely related categories. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 12|The Safety Population was a subset of randomized participants and included all patients who were administered study drug (N=293).|||Participants|||Count of Participants
2589561|NCT02291861|Secondary|Cumulative Percentage of Responders Based on Change in in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Recorded in Incremental Steps of 10 Percentage Points|"AIMS is an assessment tool used to detect and follow the severity of TD over time, composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders.~This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement.~Participants with missing data are classified as non-responders. The responder 95% CI is calculated with the Wilson (score) confidence limits. If any of the expected cell counts are < 5, exact Clopper Pearson limits are presented.~Data report the percentage of participants who responded to the percentage improvement indicated in each row."|Day 0 (Baseline), Week 12|The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment.|||percentage of participants||95% Confidence Interval|Number
2589562|NCT02291861|Secondary|Percent Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model for Repeated Measures (MMRM)|"AIMS is an assessment tool used to detect and follow the severity of TD over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders.~This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement.~MMRM with treatment group, visit, treatment group-by-visit interaction, and baseline use of DRAs as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure."|Day 0 (Baseline), Weeks 2, 4, 8 and 12|The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment. For this outcome, participants with baseline readings and during-study readings through Week 12 are included.|||percentage of baseline||Standard Error|Least Squares Mean
2589563|NCT02291861|Secondary|Percentage of Participants Who Had a 50% or Greater Reduction in Total Motor Abnormal Involuntary Movement Scale (AIMS) From Baseline to Week 12|"Responders who had a 50% or greater improvement in total motor modified AIMS at Week 12 as compared to baseline were reported as a percentage of participants with an outcome at Week 12. The responder 95% CI is calculated with the Wilson (score) confidence limits.~AIMS is an assessment tool used to detect and follow the severity of TD over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders.~This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement."|Day 0 (Baseline), Week 12|mITT population of participants. Participants with missing Week 12 data were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2589564|NCT02291861|Secondary|Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC)|"The PGIC is a single-item questionnaire that asks the patient to assess their TD symptoms at specific visits after initiating therapy. The PGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy. A treatment success was defined as much improved or very much improved at the week 12 visit.~Patients whose status at week 12 was not known, as well as patients who were not much improved or very much improved at the week 12 visit, were considered treatment failures. The success 95% CI was calculated with the Wilson (score) confidence limits."|Week 12|mITT population|||percentage of participants||95% Confidence Interval|Number
2589565|NCT02291861|Secondary|Change in the Modified Craniocervical Dystonia Questionnaire (mCDQ-24) Total Score From Baseline to Week 12|"The CDQ-24 is a disease-specific quality of life questionnaire developed for use in patients with craniocervical dystonia, including both cervical dystonia (CD) and blepharospasm (BPS). The CDQ 24 was modified such that the questions focus more directly on the impact of TD (as opposed to CD/BPS) on quality of life.~The following domains are evaluated in the mCDQ-24: stigma, emotional well-being, pain, activities of daily living, and social/family life. Each of the 24 questions were rated by patients on a scale of 0=no impairment to 4=severest impairment for a total scale of 0 - 96. Negative change from baseline scores indicate improvement.~For patients with missing data at week 12, the baseline or last available value was used as the week 12 value."|Day 0 (Baseline), Week 12|The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment. One SD-809 12 mg/day participant was missing a baseline mCDQ-24.|||units on a scale||Standard Error|Least Squares Mean
2589566|NCT02291861|Secondary|Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC)|"The CGIC is a single-item questionnaire that asks the investigator to assess a patient's TD symptoms at specific visits after initiating therapy. The CGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy.~A treatment success was defined as much improved or very much improved at the week 12 visit.~Patients whose status at week 12 was not known, as well as patients who were not much improved or very much improved at the week 12 visit, were considered treatment failures.~The success 95% confidence interval (CI) was calculated with the Wilson (score) confidence limits."|Week 12|The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment.|||percentage of participants||95% Confidence Interval|Number
2589567|NCT02291861|Primary|Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model For Repeated Measures (MMRM)|"AIMS is an assessment tool used to detect and follow the severity of tardive dyskinesia (TD) over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders.~This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement.~MMRM with treatment group, visit, treatment group-by-visit interaction, and baseline use of dopamine receptor antagonist (DRAs) as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure."|Day 0 (Baseline), Weeks 2, 4, 8 and 12|The mITT Population (N=222) included all patients in the ITT Population with a baseline AIMS score ≥6 as assessed by central video rating, were randomized to treatment, received study drug, and had at least 1 postbaseline AIMS assessment. For this outcome, participants with baseline readings and during-study readings through Week 12 are included.|||units on a scale||Standard Error|Least Squares Mean
2589568|NCT02291718|Secondary|Variation in Contrast for the Entire Vascular System (coV)|The change in contrast was measured at the proximal segment of the aorta and at the Iliac arteries for each subject.|30 minutes||||unitless||Standard Deviation|Mean
2589572|NCT02291679|Other Pre-specified|Percentage of 12-Week CSBM Overall Sustained Responders|"A 12-week CSBM Overall Sustained Responder is a participant who was a CSBM Weekly Responder for at least 9 of the 12 weeks of the Treatment Period, including ≥ 3 of the last 4 weeks. A CSBM Weekly Responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline, and completed ≥ 4 IVRS calls for the specified week.~A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Week 12|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||percentage of participants|||Number
2589573|NCT02291679|Secondary|Change From Baseline in 12-Week Abdominal Discomfort|Abdominal discomfort was measured daily using an 11-point NRS (0 = none; 10 = very severe). The participant's abdominal discomfort score for the Treatment Period is the average of the non-missing daily participant assessments of abdominal discomfort scores reported during the 12-week Treatment Period.|Baseline, Week 1 to Week 12|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||units on a scale||Standard Error|Least Squares Mean
2589574|NCT02291679|Secondary|Change From Baseline in 12-Week Abdominal Bloating|Abdominal bloating was measured daily using an 11-point NRS (0 = none; 10 = very severe). The participant's abdominal bloating score for the Treatment Period is the average of the non-missing daily participant assessments of abdominal bloating scores reported during the 12-week Treatment Period.|Baseline, Week 1 to Week 12|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||units on a scale||Standard Error|Least Squares Mean
2589575|NCT02291679|Secondary|Percentage of Month 3 CSBM Responders|"A Month 3 CSBM Responder is a participant who is a CSBM weekly responder for at least 3 of the 4 weeks of Month 3 of the Treatment Period. A CSBM weekly responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline based on a minimum of 4 complete IVRS calls for that week.~A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Month 3|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||percentage of participants|||Number
2589576|NCT02291679|Secondary|Percentage of Month 2 CSBM Responders|"A Month 2 CSBM Responder is a participant who is a CSBM weekly responder for at least 3 of the 4 weeks of Month 2 of the Treatment Period. A CSBM weekly responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline based on a minimum of 4 complete IVRS calls for that week.~A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Month 2|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||percentage of participants|||Number
2589577|NCT02291679|Secondary|Percentage of Month 1 CSBM Responders|"A Month 1 CSBM Responder is a participant who is a CSBM weekly responder for at least 3 of the 4 weeks of Month 1 of the Treatment Period. A CSBM weekly responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline based on a minimum of 4 complete IVRS calls for that week.~A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Month 1|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||percentage of participants|||Number
2589578|NCT02291679|Secondary|Percentage of 12-Week CSBM Overall Responders (>1 SBM/Week Subpopulation)|"A 12-week CSBM Overall Responder is a participant who was a CSBM Weekly Responder for at least 9 of the 12 weeks of the Treatment Period. A CSBM Weekly Responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline, and completed ≥4 IVRS calls for the specified week.~A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Week 12|Participants in the Intent-to-Treat Population who reported >1 SBM/week during the Pretreatment Period (14 days prior to randomization). Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||percentage of participants|||Number
2589579|NCT02291679|Secondary|Change From Baseline in 12-Week Straining Score|Straining was measured daily using a 5-point ordinal scale (1 = not at all; 2 = a little bit; 3 = a moderate amount; 4 = a great deal; 5 = an extreme amount). The participant's straining score for the Treatment Period is the average of the non-missing straining scores from the SBMs reported by the participant during the 12-week Treatment Period.|Baseline, Week 1 to Week 12|Intent-to-Treat Population: all randomized participants who received ≥ 1 dose of study drug and reported an SBM during the Baseline period. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||units on a scale||Standard Error|Least Squares Mean
2589580|NCT02291679|Secondary|Change From Baseline in 12-Week Stool Consistency Score|Stool consistency was measured daily using the 7-point ordinal Bristol Stool Form Scale (BSFS; 1 = separate hard lumps like nuts [difficult to pass]; 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges [passed easily]; 6 = fluffy pieces with ragged edges, a mushy stool; 7 = watery, no solid pieces [entirely liquid]). The participant's BSFS score for the Treatment Period is the average of the non-missing BSFS scores from the SBMs reported by the participant during the 12-week Treatment Period.|Baseline, Week 1 to Week 12|Intent-to-Treat Population: all randomized participants who received ≥ 1 dose of study drug and reported an SBM during the Baseline period. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||units on a scale||Standard Error|Least Squares Mean
2589581|NCT02291679|Secondary|Change From Baseline in 12-Week SBM Frequency Rate|A participant's 12-week SBM Frequency Rate is the SBM rate (SBMs/week) calculated over the 12-weeks of the Treatment Period. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.|Baseline, Week 1 to Week 12|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||SBMs/week||Standard Error|Least Squares Mean
2589582|NCT02291679|Secondary|Change From Baseline in 12-Week CSBM Frequency Rate|A participant's 12-week CSBM Frequency Rate is the CSBM rate (CSBMs/week) calculated over the 12 weeks of the Treatment Period. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.|Baseline, Week 1 to Week 12|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a secondary endpoint; data for the 145 μg dose arm were defined and evaluated as an additional endpoint per protocol.|||CSBMs/week||Standard Error|Least Squares Mean
2589583|NCT02291679|Primary|Percentage of 12-Week CSBM Overall Responders|"A 12-week CSBM Overall Responder is a participant who was a CSBM Weekly Responder for at least 9 of the 12 weeks of the Treatment Period. A CSBM Weekly Responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline, and completed ≥ 4 IVRS calls for the specified week.~A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a bowel movement BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM."|Week 12|Intent-to-Treat Population: all randomized participants who received at least one dose of study drug. Only data for the 72 μg dose versus placebo arms were prospectively defined and evaluated as a primary endpoint; per protocol, data for the 145 μg dose arm were not collected for any pre-specified primary or secondary outcome measures.|||percentage of participants|||Number
2589584|NCT02291549|Secondary|Facial Pain/Pressure Score|Determined by patients on a 6-point Likert scale from 0 (absent) to 5 (very severe). Negative values for change from baseline indicated reduction (improvement) in facial pain/pressure symptoms.|Day 90|Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 5 (1.7%) participants (3 treatment, 2 control) with missing values: 3 at baseline (1 treatment, 1 control)) and 2 at Day 90 (1 treatment, 1 control) No imputation of missing values was performed.|||units on a scale||Standard Deviation|Mean
2589585|NCT02291549|Secondary|Decreased Sense of Smell Score|Determined by patients on a 6-point Likert scale from 0 (absent) to 5 (very severe). Negative values for change from baseline indicated reduction (improvement) in sense of smell.|Day 90|Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 5 (1.7%) participants (3 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.|||units on a scale||Standard Deviation|Mean
2589586|NCT02291549|Secondary|Nasal Obstruction/Congestion Score|Determined by patients using a daily diary on a scale from 0 (no symptoms) to 3 (severe symptoms) over a period of 7 days prior to baseline and Day 90. Negative values for change from baseline indicated reduction (improvement) in nasal obstruction/congestion symptoms.|Day 90|Intent-to-treat population. Scoring for >=4 of 7 days immediately preceding the baseline and Day 90 visits was required. There were 34 (11.3%) participants with missing scores: 23 treatment and 10 control at Day 90 and 1 (treatment) at baseline. No imputation of missing values was performed.|||units on a scale||Standard Deviation|Mean
2589587|NCT02291549|Secondary|Ethmoid Sinus Obstruction|Percentage of the ethmoid sinus volume obstructed by scarring, polyps, or edema on endoscopy, as determined by an independent panel of 3 sinus surgeons based on a centralized, blinded videoendoscopy review using a 100-mm visual analogue scale (VAS), ranging from 0 (absence of obstruction) to 100 (complete obstruction). Negative values for change from baseline indicated reduction (improvement) in ethmoid sinus obstruction.|Day 90|Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 8 (2.7%) participants (6 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.|||units on a scale||Standard Deviation|Mean
2589588|NCT02291549|Secondary|Percentage of Patients Indicated for Repeat Endoscopic Sinus Surgery (RESS)|Proportion of patients still indicated for RESS at day 90 despite ongoing use of mometasone furoate nasal spray based on clinical investigator assessment using study-specific criteria. To be indicated for RESS, patients had to: (1) complain of nasal obstruction/congestion (moderate to severe) and postnasal discharge, facial pain/pressure/fullness, or altered sense of smell/taste; (2) have endoscopic evidence of persisting nasal polyps (grade >= 2 on each side); and (3) have received (required at baseline) or need a systemic steroid as noted during endoscopy.|Day 90|Intent-to-treat population, consisting of all patients in whom an implant or sham procedure was attempted. 2 participants did not complete Day 90 visit. No imputation of missing values was performed.|||Participants|||Count of Participants
2589739|NCT02290106|Secondary|Alanine Aminotransferase (ALT)|alanine aminotransferase at the 6 month timepoint|6 months|all patients with available data at baseline and final|||U/L||Standard Deviation|Mean
2589589|NCT02291549|Primary|Bilateral Polyp Grade|Polyp grade was determined by an independent panel of 3 sinus surgeons based on a centralized, blinded videoendoscopy review. Each sinus was graded from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline indicated reduction (improvement) in bilateral polyp grade.|Day 90|Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. Sensitivity analyses, including tipping point, were prespecified if missing values exceed 5%. There were 8 (2.7%) participants (6 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.|||units on a scale||Standard Deviation|Mean
2589590|NCT02291549|Primary|Nasal Obstruction/Congestion Score|Determined by patients using a daily diary on a scale from 0 (no symptoms) to 3 (severe symptoms) over a period of 7 days prior to the baseline and Day 30 visits. Negative values for change from baseline indicate reduction (improvement) in nasal obstruction/congestion symptoms.|Day 30|Intent-to-treat population. Scoring for >=4 days in 7 days before the baseline and Day 30 visits was required. Sensitivity analyses, including tipping point, were prespecified if missing values exceed 5%. There were 4 (1.3%) participants (2 treatment, 2 control) with missing values at Day 30. No imputation of missing values was performed.|||units on a scale||Standard Deviation|Mean
2589591|NCT02291510|Primary|Cmax of Plasma Metformin|Cmax = Maximum concentration from the first dose of study medication administration (0 h) to the time of the last quantifiable concentration following dose administration. Doses were administered 1 min prior to 0 h (standardized dinner) for qPM and BID dosing and 1 min prior to 12 h (standardized breakfast) for qAM and BID dosing.|Time points to create Cmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population|||ng/mL||Standard Error|Mean
2589592|NCT02291510|Primary|AUC (0-t) of Plasma Metformin|AUC (0-t) = Area under the curve from the time of dosing (0 h) to the time of the last quantifiable concentration after the standardized dinner. Doses were administered 1 min prior to 0 h (standardized dinner) for once daily in the evening (qPM) and twice daily (BID) dosing and 1 min prior to 12 h (standardized breakfast) for once daily in the morning (qAM) and BID dosing.|Time points to create AUC (0-t) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population|||ng*h/mL||Standard Error|Mean
2589593|NCT02291419|Other Pre-specified|The Number of Participants With Bleeding According to Bleeding Academic Research Consortium (BARC) Definitions||up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.||||Participants|||Count of Participants
2589594|NCT02291419|Secondary|Non-fatal Stroke|Time to first occurence of Non-fatal stroke. The number of participants with events was reported.|up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.||||Participants|||Count of Participants
2589595|NCT02291419|Secondary|All-cause Death|Time to first occurence of All-cause death. The number of participants with events was reported.|up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.||||Participants|||Count of Participants
2589596|NCT02291419|Secondary|Non-fatal Myocardial Infarction or Coronary Revascularization|Time to first occurence of Non-fatal myocardial infarction or coronary revascularization. The number of participants with events was reported.|up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.||||Participants|||Count of Participants
2589597|NCT02291419|Secondary|Cardiovascular Death|Time to first occurence of Cardiovascular death. The number of patients with events was reported.|Up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.||||Participants|||Count of Participants
2589598|NCT02291419|Primary|Major Adverse Cardiovascular Events|Time to first occurence of the composite of Cardiovascular Death, Non-fatal Myocardial Infarction, Coronary Revascularization or Non-fatal Stroke. The number of patients with events is reported.|up to 6 months. The planned duration of treatment was one year but the study was terminated after 6 months.||||Participants|||Count of Participants
2589599|NCT02291237|Secondary|Change in Treadmill Exercise Time From Baseline to Week 12|Treadmill exercise time is the time to peak exercise.|Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||min||Standard Deviation|Mean
2589600|NCT02291237|Secondary|Change in Treadmill Exercise Time From Baseline to Week 24|Treadmill exercise time is the time to peak exercise.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||min||Standard Deviation|Mean
2589601|NCT02291237|Secondary|Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 12|The MLHFQ is a 21-item quality of life (QoL) questionnaire that measures the effects of symptoms, functional limitations, and psychological distress on an individual. Each item is measured on a 6-point Likert scale (0 to 5) and is scored by summing the responses to all 21 questions. Scores range from 0 to 105, with lower scores indicating a better quality of life.|Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||Score||Standard Deviation|Mean
2589602|NCT02291237|Secondary|Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) From Baseline to Week 24|The MLHFQ is a 21-item quality of life (QoL) questionnaire that measures the effects of symptoms, functional limitations, and psychological distress on an individual. Each item is measured on a 6-point Likert scale (0 to 5) and is scored by summing the responses to all 21 questions. Scores range from 0 to 105, with lower scores indicating a better quality of life.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||Score||Standard Deviation|Mean
2589603|NCT02291237|Secondary|Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 12||Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||mL/kg/min||Standard Deviation|Mean
2589604|NCT02291237|Primary|Change in Peak Oxygen Uptake (VO2) Achieved During Cardiopulmonary Exercise Testing (CPET) From Baseline to Week 24||Baseline to Week 24|Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants in the Full Analysis Set with available data were analyzed.|||mL/kg/min||Standard Deviation|Mean
2589605|NCT02291029|Secondary|Change From Baseline in Multidimensional Fatigue Inventory (MFI)|The MFI is a patient self-reported outcome measure (questionnaires) to assess fatigue covering the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Each dimension has a possible range from 4-20. The reported total score has a range from 20-100. A reduction from baseline in MFI indicates improvement.|Baseline and Week 12|PD Population for Cohort 1 and Cohort 2. Data were not collected from participants in Cohort 3 CFZ533 Arm 1 and Cohort 3 CFZ533 Arm 2.|||units on a scale||Standard Deviation|Mean
2589606|NCT02291029|Secondary|Change From Baseline in Short Form (36) Health Survey (SF-36) Mental Component Score|The SF-36 is a 36-item, patient self-reported outcome measure (questionnaires) of patient health. The outcome of the questionnaires in eight scales results in two summary scores, physical component and mental component, both ranging from 0 - 100. An increase from baseline in either component summary score indicates reduced disease burden.|Baseline and Week 12|PD Population for Cohort 1 and Cohort 2. Data were not collected from participants in Cohort 3 CFZ533 Arm 1 and Cohort 3 CFZ533 Arm 2.|||units on a scale||Standard Deviation|Mean
2589607|NCT02291029|Secondary|Change From Baseline in Short Form (36) Health Survey (SF-36) Physical Component Score|The SF-36 is a 36-item, patient self-reported outcome measure (questionnaires) of patient health. The outcome of the questionnaires in eight scales results in two summary scores, physical component and mental component, both ranging from 0 - 100. An increase from baseline in either component summary score indicates reduced disease burden.|Baseline and Week 12|PD Population for Cohort 1 and Cohort 2. Data were not collected from participants in Cohort 3 CFZ533 Arm 1 and Cohort 3 CFZ533 Arm 2.|||units on a scale||Standard Deviation|Mean
2589608|NCT02291029|Secondary|Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS)|"The visual analogue scale used is a 100 mm VAS ranging from no disease (0 mm) to maximal disease activity (100 mm)."|Baseline and Week 12|PD Population (Statistical Analysis only for Cohort 1 and 2)|||units on a scale||Standard Deviation|Mean
2589609|NCT02291029|Secondary|Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (VAS)|"The visual analogue scale used is a 100 mm VAS ranging from no disease (0 mm) to maximal disease activity (100 mm)."|Baseline and Week 12|PD Population (Statistical Analysis only for Cohort 1 and 2)|||units on a scale||Standard Deviation|Mean
2589610|NCT02291029|Secondary|Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI)|The ESSPRI is a patient self-reported outcome measure to assess dryness, limb pain, fatigue and mental fatigue, where each of the domains normally reported as 0 (not at all) to 10 (extremely severe). The final ESSPRI score is the average of three: dryness, pain and fatigue. A reduction from baseline indicates the improvement of symptoms.|Baseline and Week 12|PD Population|||units on a scale||Standard Deviation|Mean
2589611|NCT02291029|Primary|Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)|"The effect of CFZ533 on clinical disease activity was measured by the change in ESSDAI (EULAR Sjögren's syndrome disease activity index) between baseline and week 12. The instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity.~These scores are then summed across the 12 domains in a weighted manner to provide the total score (range 0-123). A reduction from baseline indicates improvement in patients."|Baseline and Week 12|PD Population (all subjects with available Pharmacodynamics data and no protocol deviations with relevant impact on PD data)|||units on a scale||Standard Deviation|Mean
2589612|NCT02291016|Secondary|Change in Dyspnea Based on the Borg Dyspnea Scale for Shortness of Breath (Pre-dose Administration and 60 Minutes After Inhalation of Formoterol With a Nebulizer or a DPI)|The Shortness of Breath Modified Borg Dyspnea Scale The scale goes from 0-10, zero meaning no difficulty breathing and ten meaning maximal difficulty. A decrease of score indicates an improvement. Patients were asked to complete the scale pre-dose and again one hour post formoterol dose. This was completed at both visit 1 and visit 2. The value recorded was the difference between the baseline value and the post 60 minute value.|Measured at visit 1 and again at the end of visit 2|Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included.|||change in score||Standard Deviation|Mean
2589613|NCT02291016|Secondary|Peak FVC Between the Two Devices (Nebulizer and DPI)|"Steps:~A baseline (pre-dose formoterol) FVC was recorded.~Subjects were dosed with formoterol.~Serial FVC assessments were completed at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol and serial FVC values were recorded.~Peak FVC was recorded for this outcome measure and compared amongst groups."|Peak FVC at visit 1 will be compared to the peak FVC at visit 2 for any significant change.|Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included.|||L/sec||Standard Deviation|Mean
2589614|NCT02291016|Secondary|Percentage Change in Peak FVC From Baseline After Inhalation of Formoterol|"A baseline (pre-dose formoterol) FVC was recorded.~Subjects were dosed with formoterol.~Serial FVC assessments were completed at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol and serial FVC values were recorded.~A percentage of change between the baseline and peak FVC will be recorded for this outcome measure."|Measured at visit 1 and again at the end of visit 2|Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included.|||percent change||Standard Deviation|Mean
2589615|NCT02291016|Secondary|Area Under the Response Curve for FVC From Baseline Through Four Hours (AUC FVC0-4h) After Inhalation of Formoterol|"Steps:~A baseline (pre-dose formoterol) FVC was recorded.~Subjects were dosed with formoterol.~Serial FVC assessments were completed at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol and serial FVC values were recorded.~Data was all time points were used to obtain the total area under the curve"|Measured at visit 1 and again at the end of visit 2|Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included.One patient did not complete the full study, which is why only 6 participants who took formoterol with nebulizer were analyzed.|||mcg*hr/mL||Standard Deviation|Mean
2589628|NCT02290873|Primary|Success of Procedure|Measured by completion of colonoscopy, no requirement for an alternative sedative and no requirement for more than 5 top-ups of study medication within any 15 minute period in the blinded arms (remimazolam/placebo) or no requirement for more than 3 doses within any 12 minute window in the midazolam arm.|From administration of the first dose of the study drug to the end of colonoscopy||||Participants|||Count of Participants
2589616|NCT02291016|Secondary|Change in FEV1 as a Percentage of Predicted Normal After Inhalation of Formoterol|"Change in FEV1 from Baseline through 4 hours post formoterol dose. This was completed at visit 1 and visit 2.~Steps:~A baseline (pre-dose formoterol) FEV1 was recorded.~Subjects were dosed with formoterol.~Serial FEV1 assessments were completed at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol and serial FEV1 values were recorded.~A percentage of change from baseline FEV1 to each serial measurement of FEV1 was collected. The % of change at each time point was then used to get a measure of overall percentage change of the predicted FEV1 value."|Baseline through study completion (visit 1 through visit 2)|Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included. One patient did not complete the full study, which is why only 6 participants who took formoterol with Nebulizer were analyzed.|||percentage change of % predicted FEV1||Standard Deviation|Mean
2589617|NCT02291016|Secondary|Peak FEV1 Between the Two Devices (Nebulizer and DPI)|"Change in peak FEV1 from Baseline. This will be completed at visit 1 and visit 2.~Steps:~A baseline (pre-dose formoterol) FEV1 was recorded.~Subjects were dosed with formoterol.~Serial FEV1 assessments were completed at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol so a peak measurement could recorded.~5. Peak measurements from visit 1 and visit 2 will be compared for any significant change in FEV1 values."|Measured from Start of visit 1 until the completion of visit 2|Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included. One patient did not complete the full study, which is why only 6 participants who took formoterol with Nebulizer were analyzed.|||L/sec||Standard Deviation|Mean
2589618|NCT02291016|Secondary|Absolute Increase in FEV1 From Baseline After Inhalation of Formoterol|"Increase in FEV1 from Baseline to 4 hours post dose of formoterol. This will be completed at visit 1 and visit 2.~Steps:~A baseline (pre-dose formoterol) FEV1 was recorded.~Subjects was dosed with formoterol.~Serial FEV1 assessments were completed, and recorded at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol so serial FEV1 measurements could be recorded."|Measured at visit 1 and visit 2 after dosing and all FEV1 testing has been completed|Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included.One patient did not complete the full study, which is why only 6 participants who took formoterol with Nebulizer were analyzed.|||L/sec||Standard Deviation|Mean
2589619|NCT02291016|Secondary|Percentage Change in Peak FEV1 From Baseline After Inhalation of Formoterol|"Change in peak FEV1 from Baseline. This will be completed at visit 1 and visit 2.~Steps:~A baseline (pre-dose formoterol) FEV1 will be recorded.~Subjects will be dosed with formoterol.~Serial FEV1 assessments will completed at 15 minutes, 30 minutes, 1 hour, 2 hour, and 4 hour post dose of formoterol so a peak measurement can be recorded.~A percentage of change between the baseline and peak FEV1 will be recorded for this outcome measure. A higher value indicates a better result."|From pre-dose formoterol (baseline 0hrs) to 30 minutes, 1,2, and 4 hours post dose at visit 1 and measured again at visit 2|Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included. One patient did not complete the full study, which is why only 6 participants who took formoterol with Nebulizer were analyzed.|||percent change||Standard Deviation|Mean
2589620|NCT02291016|Primary|The Difference Between the Values of Area Under the Response Curve for FEV1|The difference between the values of area under the response curve for FEV1 from baseline through four hours (AUC FEV1 0-4h) after inhalation of formoterol with a nebulizer or a dry powder inhaler.|Baseline through study completion (visit 1 through visit 2)|Participants who received a dose of formoterol via nebulizer AND formoterol via dry powder were included. One patient did not complete the full study, which is why only 6 participants who took formoterol with Nebulizer were analyzed. Collected at baseline, visit 1, and visit 2 at pre-dose then 30 minutes,1hr, 2hr, and 4hr post-dose|||mcg*hr/mL||Standard Deviation|Mean
2589621|NCT02290925|Secondary|Renal Adverse Effects - 2|Renal functions are described in the table below with higher serum creatinine suggesting injury to the kidney.|Baseline, after 3 months, and after 7 months|adverse events analysis was only people who have completed or accessible for analysis. this was not a intention to treat analysis|||milligrams per deciliter||Full Range|Mean
2589622|NCT02290925|Secondary|Renal Adverse Effects -1|Renal functions are described in the table below with Lower estimated Glomerular Filtration Rate (eGFR) suggesting injury to the kidney.|baseline, after 3 months and after 7 months|adverse events analysis was only people who have completed or accessible for analysis. this was not a intention to treat analysis|||milliliters/minute/1.73m^2||Full Range|Mean
2589623|NCT02290925|Secondary|Liver Adverse Effects|liver functions are described in the table below with higher liver enzymes suggesting injury to the liver.|Baseline, after 3 months, and after 7 months|adverse events analysis was only people who have completed or accessible for analysis. this was not a intention to treat analysis|||International Units per Liter||Full Range|Mean
2589624|NCT02290925|Primary|Glycosylated Haemoglobin|HBA1c were analyzed at a centrally accredited lab using ion exchange high performance liquid chromatography standardized to NGSP|After 3 months and after 7 months (there is one month wash over period as this is a cross over trial)||||percentage of glycosylated hemoglobin||Standard Error|Mean
2589625|NCT02290873|Secondary|Time to Ready for Discharge|The time after the end of colonoscopy procedure (colonoscope out) and after the last injection of study drug or rescue sedative medication, until discharge (defined as ability to walk unassisted).|From the end of the colonoscopy until discharge (expected to be the same day). After the last dose of study drug or rescue sedative, until discharge (expected to be the same day).||||minutes||95% Confidence Interval|Median
2589626|NCT02290873|Secondary|Time to Fully Alert|The time to fully alert (time to first of three consecutive Modified Observer's Assessment of Alertness/Sedation [MOAA/S] scores of 5) after the end of colonoscopy procedure [colonoscope out], and after the last dose of study drug or rescue sedative medication|From the end of colonoscopy (colonoscope out) until the patient has recovered to fully alert and from the last injection of the study drug or rescue sedative medication until the patient has recovered to fully alert|Patients who do not reach the endpoint are censored at last MOAA/S|||minutes||95% Confidence Interval|Median
2589627|NCT02290873|Secondary|Time to Start of Procedure|The time to the start of the procedure after administration of the first dose of randomized study drug|From first dose of study drug until insertion of the colonoscope|Patients who do not reach the endpoint are excluded from the analysis.|||minutes||Inter-Quartile Range|Median
2589629|NCT02290821|Primary|Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24)|The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the ITT population. SPID 24 derived from spontaneous Pain Intensity scores assessed over 24 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ [T(i) - T(i-1)] x [((PID)(i-1) + PID(i))/2] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i. Scores were assessed hourly for the first 4 hours and then every 2 hours whilst subjects were awake. Linear interpolation was used to compute an exact SPID as of 24 hours. SPID-24 was computed after all imputation of missing assessments and post-rescue assessments had been completed.|24 hours||||units on a scale||Standard Deviation|Mean
2589630|NCT02290691|Secondary|Percentage of Subjects With Spontaneously Reported Adverse Events|"Subjects will be asked to report any other symptoms experienced in addition to the solicited immediate and vaccine reactogenicity events. Any other events reported will be tabulated as spontaneously reported adverse events."|28 days||||percentage of subjects|||Number
2589631|NCT02290691|Secondary|Percentage of Subjects With Solicited Local or Systemic Adverse Events|vaccine reactogenicity will be collected on a patient-completed diary card daily for seven days post-vaccination. The following adverse events will be solicited on the diary card: injection site pain, injection site tenderness, injection site itching, injection site swelling, injection site redness, injection site bruising, fever, fatigue, headache, nausea, chills, muscle ache.|7 Days|Data included in the analysis were collected on a 7-Day Diary Card from the safety population and grade >1.|||percentage of subjects|||Number
2589632|NCT02290691|Secondary|Percentage of Subjects With Immediate Complaints|"The following possible immediate complaints will be solicited following the 30 minute safety observation period post-vaccination: local pain, redness, induration/swelling, itching where the injection was given. The data will be reported as immediate complaints and presumed to be related to the test article. Any other symptom experienced at 30 minutes will be recorded as an adverse event."|Day 0||||percentage of participants|||Number
2589633|NCT02290691|Primary|The Number of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titer.|Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.|28 Days|Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in the Immunogenicity Population.|||participants|||Number
2589634|NCT02290691|Primary|Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)|The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio (GMT with Needle-Free / GMT with Needle and Syringe) antigen will not exceed 1.5 fold.|28 Days|Geometric mean titers of antibodies against the hemagglutinin (HA) antigens were assessed in the immunogenicity population.|||Titers||Standard Deviation|Geometric Mean
2589635|NCT02290613|Secondary|Hemodynamics|venous oxygen saturation (SvO2)|baseline, 6 months||||% saturation||Standard Deviation|Mean
2589636|NCT02290613|Secondary|Hemodynamics|PAWP (pulmonary arterial wedge pressure)|baseline , 6 months||||mmHg||Standard Deviation|Mean
2589637|NCT02290613|Secondary|Hemodynamics|cardiac index (CI)|baseline, 6 months||||L/min/m^2||Standard Deviation|Mean
2589638|NCT02290613|Secondary|Hemodynamics|cardiac output (CO)|baseline, 6 months||||L/min||Standard Deviation|Mean
2589639|NCT02290613|Secondary|Hemodynamics|pulmonary vascular resistance|baseline, 6 months||||Wood Units||Standard Deviation|Mean
2589640|NCT02290613|Secondary|Hemodynamics|right atrial pressure|change from baseline to 6 months||||mmHg||Standard Deviation|Mean
2589641|NCT02290613|Secondary|WHO-functional Class|"The World Health Organization functional class includes four categories with~Patients with Pulmonary Hypertension but without any resulting limitation of physical activity.~Patients with Pulmonary Hypertension resulting in slight limitation of physical activity.~Patients with Pulmonary Hypertension resulting in marked limitation of physical activity.~Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms."|baseline||||Participants|||Count of Participants
2589642|NCT02290613|Secondary|Echocardiography|sPAP (systolic pulmonary arterial pressure)|baseline, 6 months||||mmHg||Standard Deviation|Mean
2589643|NCT02290613|Secondary|Echocardiography|TAPSE (tricuspid annular plane systolic excursion)|baseline, 6 months||||cm||Standard Deviation|Mean
2589644|NCT02290613|Secondary|Echocardiography|RV-area (right ventricular area)|baseline, 6 months||||cm^2||Standard Deviation|Mean
2589645|NCT02290613|Secondary|Echocardiography|RA-area (right atrial area)|baseline, 6 months||||cm^2||Standard Deviation|Mean
2589646|NCT02290613|Secondary|Lung Function|residual volume|baseline, 6 months||||Litres||Standard Deviation|Mean
2589647|NCT02290613|Secondary|Lung Function|TLC (total lung capacity)|baseline, 6 months||||Litres||Standard Deviation|Mean
2589648|NCT02290613|Secondary|Lung Function|FEV1 (forced expiratory volume in one second)|baseline, 6 months||||Litres||Standard Deviation|Mean
2589649|NCT02290613|Secondary|Lung Function|FVC (forced vital capacity)|baseline, 6 months||||% of target||Standard Deviation|Mean
2589650|NCT02290613|Secondary|Lung Function|DLCo (diffusing capacity or transfer factor of the lung for carbon monoxide (CO))|baseline, 6 months||||mmol/min/kPa||Standard Deviation|Mean
2589651|NCT02290613|Secondary|Lung Function|DLCo (diffusing capacity or transfer factor of the lung for carbon monoxide (CO))|baseline,6 months||||% of target value||Standard Deviation|Mean
2589652|NCT02290613|Secondary|Quality of Life (SF-36) Questionnaire|SF-36 Questionnaire; physical Summation score; All scores and subscores of the SF-36 questionnaire range from 0 (low quality of life) to 100 (high quality of life). The physical Summation score is a compound score including the physical dimensions of the SF-36.|baseline, 6 months||||units on a scale||Standard Deviation|Mean
2589653|NCT02290613|Secondary|Borg Dyspnea Index|measured directly after 6 minute walking distance; The Borg dyspnea index is an standardized scale which reports the subjective feeling of exertion from 0 (no dyspnea) to 10 (maximal feeling of dyspnea).|baseline, 6 months||||units on a scale||Standard Deviation|Mean
2589654|NCT02290613|Secondary|6-Minute-walking Test||baseline, 6 months||||meters||Standard Deviation|Mean
2589656|NCT02290613|Primary|Mean Pulmonary Arterial Pressure Change From Baseline|Determine whether mean pulmonary arterial pressure of SSc patients with borderline - PAH (mPAP 21 24 mmHg, TPG >11 mmHg) can be reduced by 3 mm Hg (absolute change baseline vs. 6 months; equals 15%) following treatment with ambrisentan 10 mg/die (initiated with 5 mg/die and elevated up to 10 mg/die) over 6 months (primary endpoint) compared to baseline and placebo.|baseline, 6 months||||mmHg||Standard Deviation|Mean
2589657|NCT02290574|Secondary|Pathologic Complete Response of Hyperthermia With CCRT|Pathologic complete response of hyperthermia with CCRT was achieved in 20% of participants|expected average of 6 weeks after neoadjuvant treatement||||participants|||Number
2589658|NCT02290574|Secondary|Rate of Open TME|Rate of open TME was measured as ten percent|expected average of 6 weeks after neoadjuvant treatement||||participants|||Number
2589659|NCT02290574|Primary|Adverse Event of Laparoscopic TME and Hyperthermia With CCRT|Adverse event according to CTCAE V 4.0 after laparoscopic TME and hyperthermia with CCRT|expected average of 16 weeks after neoadjuvant treatement||||Participants|||Count of Participants
2589660|NCT02290574|Primary|Pathologic Response of Thermo-radio-chemotherapy|The pathologic response was assessed according to the Dworak's system. The pathologic response grades were as follows: grade 0, no response; grade 1, dominant tumor mass with obvious fibrosis, vasculopathy, or both (minimal response); grade 2, dominant fibrotic changes with a few easy-to-find tumor cells or groups (moderate response); grade 3, few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance (near complete response); and grade 4, no viable tumor (complete response)|expected average of 6 weeks after neoadjuvant treatement|40% of pathologic response rate of laparoscopic TME after CCRT and hyperthermia treament|||participants|||Number
2589661|NCT02290574|Primary|Curative Resection Rate of Laparoscopic TME|Curative resection rate of laparoscopic TME after CCRT and hyperthermia treament|expected average of 6 weeks after neoadjuvant treatement||||Participants|||Count of Participants
2589662|NCT02290509|Primary|Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Immunogenicity will be evaluated prior to vaccination and at 28 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) were calculated.|Day 0 and Day 28 after final vaccination|The immunogenicity population includes all randomized subjects who received a dose of study vaccine, provided serum samples for baseline (Day 0) and Day 28 HAI titers (within the specified windows) and have no major protocol deviations that might have adversely affect the immune response.|||titer||95% Confidence Interval|Geometric Mean
2589663|NCT02290509|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)||Six months post-vaccination|The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine.|||participants|||Number
2589664|NCT02290509|Secondary|Number of Participants With Systemic and Injection Site Reactogenicity||Days 0-7|The Reactogenicity Population includes subjects who recorded any systemic reaction data and injection site reaction data following administration of study vaccine. This was two subjects less than the Safety Population.|||participants|||Number
2589665|NCT02290509|Primary|Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Seroconversion is defined as: Either a pre vaccination titer < 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at Day 28 after the final vaccination.|Day 28 after final vaccination|The immunogenicity population includes all randomized subjects who received a dose of study vaccine, provided serum samples for baseline (Day 0) and Day 28 HAI titers (within the specified windows) and have no major protocol deviations that might have adversely affect the immune response.|||percentage of participants||95% Confidence Interval|Number
2589666|NCT02290444|Other Pre-specified|Change From Baseline in Concurrent Medications|Initiation or discontinuation of any medications occurring over the course of the study; monitored by clinician and study personnel.|Up to 3 months|||||||
2589667|NCT02290444|Other Pre-specified|Incidence of Adverse Events|The number of patients reporting adverse events over the course of the study|Up to 3 months|||||||
2589668|NCT02290444|Secondary|Change From Baseline on the Fatigue Severity Scale (FSS)|A self-report measure of fatigue. 1 (no fatigue) to 9 (severe fatigue). The difference in total score on FSS from Day 0 to Day 90 were analyzed to address change in this outcome.|Day 0 and Day 90|The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.|||Total Score||Standard Deviation|Mean
2589669|NCT02290444|Secondary|Change From Baseline on the Beck Depression Inventory-Fast Screen (BDI-FS)|A self-report, multiple choice inventory of depression. Minimum of 0, maximum of 21. Higher score indicates higher levels of depression. The difference in total score on the BDI-FS from Day 0 to Day 90 were analyzed to address change in this outcome.|Day 0 and Day 90||||Total Score||Standard Deviation|Mean
2589670|NCT02290444|Secondary|Change From Baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)|A self and informant rating measure of perceived cognitive problems. Minimum of 0, maximum of 60. Higher scores indicates greater self-reported neuropsychological impairment. The difference in total score on the MSNQ from Day 0 to Day 90 were analyzed to address change in this outcome.|Day 0 and Day 90|The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.|||Total Score||Standard Deviation|Mean
2589671|NCT02290444|Secondary|Change From Baseline on the Expanded Disability Status Scale (EDSS).|A clinician assigned measure of disability specific to MS. Minimum of 0 (no disability), maximum of 10 (death due to MS). Higher scores indicate greater disability. The difference in total score on the EDSS from Day 0 to Day 90 were analyzed to address change in this outcome.|Day 0 and Day 90|The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.|||Total Score||Inter-Quartile Range|Median
2589672|NCT02290444|Primary|Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II)|A measure of auditory/verbal episodic memory. Minimum of 0, maximum of 80. Higher score indicates better performance. The difference in total learning score on the CVLT-II from Day 0 to Day 90 were analyzed to address change in this outcome.|Day 0 and Day 90|The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.|||Total Learning Score||Standard Deviation|Mean
2589673|NCT02290444|Primary|Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R)|A measure of visual/spatial memory. Minimum of 0, maximum of 36. Higher score indicates better performance. The difference in total learning score on the BVMT-R from Day 0 to Day 90 were analyzed to address change in this outcome.|Day 0 and Day 90|The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.|||Total Learning Score||Standard Deviation|Mean
2589674|NCT02290444|Primary|Change From Baseline on the Paced Auditory Serial Addition Test (PASAT)|A measure of auditory processing speed and working memory. Minimum value of 0, maximum value of 60. Higher score indicates better performance. The difference in total correct on the PASAT from Day 0 to Day 90 were analyzed to address change in this outcome.|Day 0 and Day 90|The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.|||Total Correct||Standard Deviation|Mean
2589675|NCT02290444|Primary|Timed 25-foot Walk|An MS-specific measure of functional status walking speed. How many seconds does it take to walk 25 feet. Ceiling value of 300 seconds.|Day 0 and Day 90|The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.|||Seconds||Standard Deviation|Mean
2589676|NCT02290444|Primary|Change From Baseline on the Symbol Digit Modalities Test (SDMT)|A measure of visual processing speed and working memory. Minimum score of 0, Maximum score of 120. Higher scores indicate better performance. The difference in total correct responses on the SDMT from Day 0 to Day 90 were analyzed to address change in this outcome.|Day 0 and Day 90|The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.|||Total Correct||Standard Deviation|Mean
2589677|NCT02290431|Secondary|Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Vz/F|Vz/F: The apparent volume of distribution during terminal phase (associated with Lambda_z)|Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose|PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ.|||Litre (L)||Geometric Coefficient of Variation|Geometric Mean
2589678|NCT02290431|Secondary|Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: CL/F|CL/F: The apparent total body clearance of drug from the plasma|Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose|PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ.|||Litre/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2589679|NCT02290431|Secondary|Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Lambda_z|Lambda_z: The terminal elimination rate constant (h-1)|Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose|PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ.|||1/hour (1/h)||Geometric Coefficient of Variation|Geometric Mean
2589680|NCT02290431|Secondary|Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: T1/2|T1/2: The elimination half-life associated with the terminal slope (Lambda_z) of a semi logarithmic concentration-time curve|Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h 48h post dose|PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ.|||hour (h)||Geometric Coefficient of Variation|Geometric Mean
2589681|NCT02290431|Secondary|Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Tmax|Tmax: The time to reach maximum (peak) plasma concentration. PK sample collection was performed in subjects who agreed to blood samplings for the PK assessments of PAN and BTZ. The order of administration of the 3 study treatment components was 1) PAN, 2) Dex, and 3) BTZ.|Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose|PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ.|||hour (h)||Full Range|Median
2589682|NCT02290431|Secondary|Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: Cmax|Cmax: The maximum (peak) observed plasma concentration. PK sample collection was performed in subjects who agreed to blood samplings for the PK assessments of PAN and BTZ. The order of administration of the 3 study treatment components was 1) PAN, 2) Dex, and 3) BTZ.|Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose|Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2589746|NCT02289989|Primary|Change of the Clinical Efficacy Rated by a Study Physician|Physician was asked to grade four characteristics: erythema, infiltration/papulation, excoriation and lichenification. The grade was none (0), mild (1), moderate (2) and severe (3).|Baseline to day 28||||participants|||Number
2589683|NCT02290431|Secondary|Composite PharmacoKinetics (PK) of Panobinostat and Bortezomib: AUClast, AUC0-24h, AUC0-48h, AUCinf|PK sample collection was performed in subjects who agreed to blood samplings for the PK assessments of PAN and BTZ. The order of administration of the 3 study treatment components was 1) PAN, 2) Dex, and 3) BTZ.|Predose, 0.5h, 1h, 2h, 3h, 4h 8h, 24h, 48h post dose|PAS: Pharmacokinetic Analysis Set (PAS): The PK analysis set for PAN (PAS-PAN) consisted of all subjects with at least one evaluable PK concentration of PAN. The PK analysis set for BTZ (PAS-BTZ) consisted of all subjects with at least one evaluable PK concentration of BTZ.|||h.ng/mL||Geometric Coefficient of Variation|Geometric Mean
2589684|NCT02290431|Secondary|Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score|QoL as measured by Functional Assessment of Cancer Therapy/ Gynecology Oncology Group Neurotoxicity (FACT/GOG-NTX) scale calculated scores and changes from baseline were summarized by visit. The FACT/GOG-Ntx is a measure to assess neurotoxicity from systemic chemotherapy. The recall period for this measure is the past 7 days. FACT/GOG-Ntx Total Score: 0 - 152 (28 + 28 + 24 + 28 + 44 = 152). (FACT-G Physical Well-Being Score: 0 - 28, FACT-G Social/Family Well-Being Score: 0 - 28, FACT-G Emotional Well-Being Score: 0 - 24, FACT-G Functional Well-Being Score: 0 - 28, FACT/GOG-Ntx Neurotoxicity Subscale Score: 0 - 44). 4. The scales are combined. The higher the score, the better the QOL.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, and 156|FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component.|||scores on a scale||Full Range|Median
2589685|NCT02290431|Secondary|Duration of Response (DOR) Per Investigator|DOR is defined as the time from date of the first documented CR/nCR or PR to the date of the first documented progression or relapse or death due to MM|duration of study up to approx. 4 years|FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component.|||months||95% Confidence Interval|Median
2589686|NCT02290431|Secondary|Time to Progression/Relapse (TTP) Per Investigator|TTP is defined as the time from the date of the first dose of study treatment to the date of the first documented disease progression or relapse|duration of study up to approx. 4 years|FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component.|||months||95% Confidence Interval|Median
2589687|NCT02290431|Secondary|Time to Response (TTR) Per Investigator|TTR is defined as the time from the date of first dose of study treatment to first documented response (PR or nCR or CR) per modified EBMT criteria as assessed by investigator|duration of study up to approx. 4 years|FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component.|||months||95% Confidence Interval|Median
2589688|NCT02290431|Secondary|Minimal Response Rate (MRR) Per Investigator|MRR is based on modified EBMT criteria per investigator assessment|after 24 weeks (8 cycles; cycle = 21 days)|FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component.|||Percentage of participants|||Number
2589689|NCT02290431|Secondary|Overall Survival (OS)|OS is defined as time from first dose of study treatment to death|up to 30 days after end of study, approx. 4 years|FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component.|||months||95% Confidence Interval|Median
2589690|NCT02290431|Secondary|Overall Response Rate (ORR)|ORR is defined as the proportion of participants with CR, nCR or partial response (PR) based on modified EBMT criteria per investigator assessment|24 weeks (8 cycles; cycle = 21 days)|FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component.|||Percentage of participants||95% Confidence Interval|Number
2589691|NCT02290431|Secondary|Progression Free Survival (PFS)|PFS is defined as time from first dose of study treatment to progression or death due to any cause, based on modified European Society for Bone and Marrow Transplantation (EBMT) criteria per Investigator's assessment|duration of study up to approx. 4 years|FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component.|||months||95% Confidence Interval|Median
2589692|NCT02290431|Primary|Percentage of Participants With Near Complete Response (nCR)/ Complete Response (CR) Rate|nCR plus CR rate after 8 cycles of therapy as defined by the modified European Society for Bone and Marrow Transplantation (EBMT) criteria per investigator assessment as the proportion of participants with nCR or CR as their best overall response.|after 24 weeks (8 cycles; cycle = 21 days)|Full Analysis Set (FAS): The Full analysis set (FAS) comprised of all subjects who took at least one dose of any study treatment component.|||Percentage of participants||90% Confidence Interval|Number
2589693|NCT02290340|Secondary|Number of Participants Positive for Anti-Drug Antibodies to MEDI8897|A participant was considered ADA-positive if the participant had a positive reading at any time point post baseline. Titers greater than or equal to 50 were considered positive.|Pre-dose at Baseline (Days -7 to -1) and on Days 31, 151, and 361 Post-dose|The As-treated Population included participants who received any study drug.|||Participants|||Count of Participants
2589694|NCT02290340|Secondary|Extravascular Volume of Distribution (Vz/F) of MEDI8897|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.|Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose|"The As-treated Population included all participants who received any study drug. Here, N signifies number of participants analyzed for this outcome measure."|||mL||Standard Deviation|Mean
2589695|NCT02290340|Secondary|Extravascular Clearance (CL/F) of MEDI8897|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose|"The As-treated Population included all participants who received any study drug. Here, N signifies number of participants analyzed for this outcome measure."|||mL/day||Standard Deviation|Mean
2589696|NCT02290340|Secondary|Terminal Elimination Half Life (t1/2) of MEDI8897|Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.|Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose|"The As-treated Population included all participants who received any study drug. Here, N signifies number of participants analyzed for this outcome measure."|||Day||Standard Deviation|Mean
2589740|NCT02290106|Primary|Liver Fat|liver fat content as measured by 1H-magnetic resonance spectroscopy|6 months|All participants with baseline and final data were analyzed. In addition to patients who discontinued from the study, some patients were unable to have MRI scan due to inability to fit in the scanner or unanticipated claustrophobia.|||% liver fat (hepatic fat fraction)||Standard Deviation|Mean
2589697|NCT02290340|Secondary|Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of MEDI8897|The pharmacokinetic (PK) parameter AUC (0-infinity) was estimated based on the serum concentrations of MEDI8897.|Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose|"The As-treated Population included all participants who received any study drug. Here, N signifies number of participants analyzed for this outcome measure."|||Day*mcg/mL||Standard Deviation|Mean
2589698|NCT02290340|Secondary|Area Under the Concentration-Time Curve From Day 1 to Day 151 (AUC [1-151]) of MEDI8897|Area under the concentration-time curve of the MEDI8897 in serum over the time interval from day 1 to day 151 (AUC1-151).|Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), and 150 (± 7) Post-dose|"The As-treated Population included all participants who received any study drug. Here, N signifies number of participants analyzed for this outcome measure."|||Day*mcg/mL||Standard Deviation|Mean
2589699|NCT02290340|Secondary|Maximum Observed Serum Concentration (Cmax) of MEDI8897|The Cmax is the maximum observed serum concentration of MEDI8897.|Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose|"The As-treated Population included all participants who received any study drug. Here, N signifies number of participants analyzed for this outcome measure."|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2589700|NCT02290340|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897|The Tmax defined as time at which maximum observed concentration of MEDI8897 (Cmax) was observed.|Pre-dose at Baseline (Days -7 to -1) and on Days 7 (± 1), 30 (± 5), 150 (± 7) and 360 (± 7) Post-dose|"The As-treated Population included all participants who received any study drug. Here, N signifies number of participants analyzed for this outcome measure."|||Day||Standard Deviation|Mean
2589701|NCT02290340|Primary|Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events|Laboratory abnormalities determined by the investigator to be clinically significant that occurred after study drug dosing through 151 days post-dose that were absent before treatment or that worsened relative to pre-treatment state were reported as TEAEs. Laboratory evaluations (haematology and serum chemistry) of blood samples were performed.|From Study Drug Administration (Day 1) Through the Follow-up Period (Day 151)|The As-treated Population included all participants who received any study drug.|||Participants|||Count of Participants
2589702|NCT02290340|Primary|Number of Participants With Treatment-Emergent Adverse Events of Special Interest|An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator (that is, within 24 hrs of knowledge of the event) to the sponsor. The AESIs for this study were hepatic function abnormality meeting the definition of Hy's law, hypersensitivity reactions including anaphylaxis, immune complex disease, and thrombocytopenia. Treatment-emergent AESIs were collected from the time of dosing until Day 361 post-dose.|From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)|The As-treated Population included all participants who received any study drug.|||Participants|||Count of Participants
2589703|NCT02290340|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity of a participant who received MEDI8897. TEAEs and TESAEs were the events that occurred between administration of study drug (Day 1) and Day 361 that were absent before treatment or that worsened relative to pre-treatment state.|From Study Drug Administration (Day 1) Through the Follow-up Period (Day 361)|The As-treated Population included all participants who received any study drug.|||Participants|||Count of Participants
2589704|NCT02290223|Secondary|Tobacco Use|Participants were asked how many days they had smoked cigarettes in past 30 days at baseline, 6 and 12 months. Results are reported as number and percent who reported they smoked cigarettes on at least one day in past 30 days.|Baseline and 6 and 12 months post-randomization|Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.|||Participants|||Count of Participants
2589705|NCT02290223|Secondary|Alcohol Use|"The number and percent of participants who report heavy drinking in past 3 months are reported at baseline and 6 and 12 months. Heavy drinking is defined as 5+ drinks per day or 15+ drinks per week for males under age 65, and 4+ drinks per day or 8+ drinks per week for females and males over age 65."|Baseline and 6 and 12 months post-randomization|Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.|||Participants|||Count of Participants
2589706|NCT02290223|Secondary|Substance Use|"Participants were asked about 9 categories of substance use in past 3 months, based on NIDA-modified Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). Results are reported as number and percent for three categories: prescription/street opioids, cannabis and sedatives/sleeping pills. Remaining categories (cocaine, methamphetamines, stimulants, inhalants) were collapsed into other category."|Baseline and 6 and 12 month post-randomization|"Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline. Categories do not add up to number analyzed because answer were check all that apply and multiple answers per respondent were allowed."|||participants who used given substance|||Number
2589707|NCT02290223|Secondary|Met Baseline Goals for Opioid Use at 6 and 12 Months|"Participants were asked at 6 and12 months to what extent they felt they met goals for opioid use stated at baseline. Results are presented as number and percent who reported to a great extent/somewhat, vs. very little/not al all."|6 and 12 months post-randomization|Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.|||Participants|||Count of Participants
2589708|NCT02290223|Secondary|Goals for Opioid Use at Baseline|Participants were asked at baseline about their long-term goals for using prescription opioids for pain management. Results are presented as number and percent who wanted to stay the same/increase use, and number and percent who wanted to decrease or stop use of prescription opioids.|baseline||||Participants|||Count of Participants
2589709|NCT02290223|Secondary|Pain Management Strategies- Exercise, Stretching or Physical Therapy|"Participants were asked to identify which of the following they were currently using to manage their pain: opioid medication prescribed by a doctor; non-opioid medication prescribed by a doctor; over the counter medication; complementary/alternative medicine; meditation, relaxation, or mindfulness practice; pain classes or therapy; massage or other bodywork; exercise, stretching or physical therapy; or other. Results are reported as number and percent of participants who endorsed exercise, stretching or physical therapy. Only the outcomes with significant differences between two arms at 6 and/or 12 months are reported."|Baseline and 6 and 12 months post randomization|Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.|||Participants|||Count of Participants
2589710|NCT02290223|Secondary|Pain Management Strategies- Mindfulness, Meditation and Relaxation|"Participants were asked to identify which of the following they were currently using to manage their pain: opioid medication prescribed by a doctor; non-opioid medication prescribed by a doctor; over the counter medication; complementary/alternative medicine; meditation, relaxation, or mindfulness practice; pain classes or therapy; massage or other bodywork; exercise, stretching or physical therapy; or other. Results are reported as number and percent of participants who endorsed mindfulness, meditation and relaxation. Only the outcomes with significant differences between two arms at 6 and/or 12 months are reported."|Baseline and 6 and 12 months post randomization|Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.|||Participants|||Count of Participants
2589711|NCT02290223|Secondary|Prescription Opioid Use (EHR)|Opioid prescription dispensations were extracted from electronic health records and converted into morphine milligram equivalent (MME), by multiplying the quantity of each prescription by the strength of prescription (milligrams of opioid/unit dispensed). The resulting product is then multiplied by the conversion factor for MMEs. We calculated the average daily MME dispensed for the relevant time periods. Results are reported for 3 time periods: 1) 6 months prior to baseline, 2) 3 months prior to 6 month interview, and 3) 6 months prior to 12 month interview. For all 3 time periods, active membership in Kaiser health plan is required for 4 of 6 months, and 3 of 3 months for the 3-month period used in 6 month analysis.|Baseline and 6 and 12 months post randomization|EHR data were extracted for all study participants who remained active Kaiser members in the follow-up period, regardless of whether they completed the follow-up surveys or not. Due to incomplete membership in the follow-up period, 13 people were excluded from the 6-month EHR outcomes, and 16 people were excluded from the 12-month EHR outcomes.|||MME||Standard Deviation|Mean
2589712|NCT02290223|Secondary|Attendance at Health Education Classes (Self-reported)|"Attendance at Kaiser's health education classes was reported by participants on questionnaire at baseline, 6 and 12 months. Results are reported as number and % of patients who attended health education class during specified time period (ever at baseline, and past 6 months at 6/12 months)."|Baseline and 6 and 12 months post randomization|Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.|||Participants|||Count of Participants
2589713|NCT02290223|Secondary|Use of Online Health and Wellness Resources (Self-reported)|"Use of Kaiser's online portal (kp.org) was reported by participants on questionnaire at baseline, 6 and 12 months. Participants were asked different ways in which portal was used, and if they used kp.org's health and wellness resources (healthy lifestyle programs, wellness coaching, audio podcasts, recipe blogs, tools/calculators, videos). Results reported here are number and % of patients who reported using Kaiser's online health and wellness resources during specified time period (ever at baseline, and past 6 months at 6/12 months)."|Baseline and 6 and 12 months post randomization|Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.|||Participants|||Count of Participants
2589714|NCT02290223|Secondary|Health Care Utilization Portal Use (EHR)|Use of Kaiser's online portal is extracted from electronic health record. Results are reported as number and % of patients who used the portal during specified time periods: 1) 6 month period prior to baseline, 2) 3 months prior to 6 month interview, and 3) 6 months prior to 12 month interview. For all three time periods, active membership in Kaiser health plan is required for 4 of 6 months, and 3 of 3 months for the 3-month period used in 6 month analysis.|Baseline and 6 and 12 months post randomization|EHR data were extracted for all study participants who remained active Kaiser members in the follow-up period, regardless of whether they completed the follow-up surveys or not. Due to incomplete membership in the follow-up period, 13 people were excluded from the 6-month EHR outcomes, and 16 people were excluded from the 12-month EHR outcomes.|||Participants|||Count of Participants
2589715|NCT02290223|Secondary|Health Care Utilization Service Visits (EHR)|Primary care services (number of non-urgent outpatient visits) and acute care services (number of emergency room (ER) visits and inpatient stays) within KPNC as extracted from the electronic health records are reported. Average number of visits are reported for 6 month period prior to baseline, for 3 months prior to 6 month interview, and 6 months prior to 12 month interview. For all three time periods, active membership in Kaiser health plan is required for 4 of 6 months, and 3 of 3 months for the 3-month period used in 6 month analysis.|Baseline and 6 and 12 months post randomization|EHR data were extracted for all study participants who remained active Kaiser members in the follow-up period, regardless of whether they completed the follow-up surveys or not. Due to incomplete membership in the follow-up period, 13 people were excluded from the 6-month EHR outcomes, and 16 people were excluded from the 12-month EHR outcomes.|||visits||Standard Deviation|Mean
2589716|NCT02290223|Secondary|Patient Provider Interactions|The Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI) is used to measure patients' self-efficacy in obtaining medical information and attention to their medical concerns from physicians.Ten questions are measured on a scale from 1 (not at all confident) to 5 (very confident) and the range of possible scores is 10-50. Average scores are reported, with higher score reflecting more confidence in interacting with his/her physician.|Baseline and 6 and 12 months post randomization|Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.|||units on a scale||Standard Deviation|Mean
2590077|NCT02287467|Secondary|Change in Viral Load|Change in nasopharyngeal viral load from baseline to day 3|Day 3|Participants with viral load results at both baseline and day 3. Participants with undetectable viral load results at baseline are excluded.|||log10 RNA||Standard Error|Mean
2589717|NCT02290223|Secondary|Patient Provider Communication|The Communication Assessment Tool (CAT) measures patients' perceptions of physician performance with regard to communication and interpersonal skills. It is a 14-item instrument that asks respondents to rate their primary primary care physician based on the last couple of visits. The answers are reported using a 5-point rating scale, with 1=poor to 5=excellent. Average scores are reported.|Baseline and 6 and 12 months post randomization|Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.|||units on a scale||Standard Deviation|Mean
2589718|NCT02290223|Secondary|Function: Social Activities and Roles|"The Patient-Reported Outcome Measurement Information System (PROMIS) Global Health instrument is a system of highly reliable, and precise measures of patient-reported outcomes in physical and mental health and social well-being. This function domain is based on a single item: In general, please rate how well you carry out your usual social activities and roles. (This includes activities at home, at work and in your community, and responsibilities as a parent, child, spouse, employee, friend, etc.) Answers are reported on scale 1-5, with 1=poor to 5=excellent. Average raw scores are reported, with higher scores reflecting higher functioning."|Baseline and 6 and 12 months post randomization|Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.|||units on a scale||Standard Deviation|Mean
2589719|NCT02290223|Secondary|Function: Everyday Physical Activities|"The Patient-Reported Outcome Measurement Information System (PROMIS) Global Health instrument is a system of highly reliable, and precise measures of patient-reported outcomes in physical and mental health and social well-being. This function domain is based on a single item: To what extent are you able to carry out your everyday physical activities such as walking, climbing stairs, carrying groceries, or moving a chair? Answers are reported on scale 1-5, with 1=not at all to 5=completely. Average raw scores are reported, with higher scores reflecting higher functioning."|Baseline and 6 and 12 months post randomization|Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.|||units on a scale||Standard Deviation|Mean
2589720|NCT02290223|Secondary|Pain Intensity|"Measured with the Patient-Reported Outcome Measurement Information System (PROMIS) Global Health instrument. PROMIS is a system of highly reliable, and precise measures of patient-reported outcomes in physical and mental health and social well-being. Pain intensity is assessed using a single item (How would you rate your pain, on average?). The average raw score is reported on scale 1-10, with 1=no pain to 10= worst imaginable."|Baseline and 6 and 12 months post randomization|Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.|||units on a scale||Standard Deviation|Mean
2589721|NCT02290223|Secondary|Self-Efficacy|Pain Self-Efficacy Questionnaire (PSEQ) is an established 10-item measure of pain self-efficacy that is widely used in clinical settings to assess confidence in one's ability to work and lead a normal life despite pain. Each item is rated on a 7-point scale with 0= not at all confident and 6=extremely confident. A total score is calculated by summing the scores for each of 10 items, yielding max score of 60. A higher score indicates higher self-efficacy.|Baseline and 6 and 12 months post randomization|Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.|||units on a scale||Standard Deviation|Mean
2589722|NCT02290223|Secondary|Pain Coping|The 42-item Chronic Pain Coping Inventory (CPCI) is used to assess behavioral and cognitive pain coping strategies. It contains 8 subscales: Guarding, Resting, Asking for Assistance, Relaxation, Task Persistence, Exercising/Stretching, Coping Self-Statements, and Seeking Social Support. For each subscale, patients were asked the number of days (0-7 days) he/she performed each task (4-7 tasks). The mean score for each subscale is reported, with possible range of scores 0-7. The CPCI was developed to assess the behavioral coping strategies that are taught and encouraged during treatment (eg, relaxation, exercising, task persistence), ones that are discouraged (eg, guarding, resting, asking for assistance), and one neutral strategy (seeking social support). Active strategies are defined as adaptive coping responses (eg, staying busy or active), and higher scores are associated with positive coping.|6 and 12 months post randomization|For brevity purposes, the baseline values are not included in the table (n=189 intervention and n=187usual care). There were 354 participants included in the 6 mo analysis (n=173 intervention and n=181 usual care) and 342 participants in 12 mo analysis (n=166 intervention and n=176 usual care).|||units on a scale||Standard Deviation|Mean
2589723|NCT02290223|Secondary|Opioid Misuse COMM|The Current Opioid Misuse Measure (COMM) is used to identify aberrant behaviors related to long-term opioid treatment. It is a clinical screening tool for monitoring patients for opioid overuse and misuse in six areas. The COMM contains 17 items with total score range of 0-68, and a score of 9 or greater is considered positive. It uses a low cut off value as it is intended to over-identify misuse. Results reported are the number and % of participants who score => 9.|Baseline and 6 and 12 months post randomization|The numbers at 6/12 months are lower than at baseline due to lost to follow up/withdrawals. In addition, the denominators for 6/12 month COMM are lower than other outcomes because questions were ONLY asked if participants took opioids at 6/12 (therefore, 36 excluded at 6 months, n=19 INT, n=17 UC, and 44 excluded at 12 months, n=25 INT, n=19 UC).|||Participants|||Count of Participants
2589724|NCT02290223|Secondary|Opioid Misuse SOAPP|The Screener and Opioid Assessment for Patients in Pain (SOAPP-5) is a 5 item survey used to identify aberrant behaviors related to long-term opioid treatment. Each item is rated 0 to 4 (with 0=never and 4=very often); ratings are added for all 5 items resulting in a range of possible scores 0-20. A higher score indicates greater risk for patients on long term opioids, and a score of => 4 is considered positive. Results reported are the number and % of participants who score => 4.|Baseline and 6 and 12 months post randomization|The numbers at 6/12 months are lower than at baseline due to lost to follow up/withdrawals. In addition, the denominators for 6/12 month SOAPP are lower than other outcomes because questions were ONLY asked if participants took opioids at 6/12 (therefore, 36 excluded at 6 months, n=19 INT, n=17 UC, and 44 excluded at 12 months, n=25 INT, n=19 UC).|||Participants|||Count of Participants
2589741|NCT02290106|Primary|Insulin-stimulated Glucose Uptake|insulin-stimulated glucose uptake measured by euglycemic hyperinsulinemic clamp|6 months|All patients with results for baseline and final. In addition to 3 participants who did not finish the study, 2 participants were unable to undergo clamp.|||mg/kg/minute||Standard Deviation|Mean
2589725|NCT02290223|Secondary|Satisfaction With Care|"Satisfaction with primary care provider is reported on a scale from 1-10, where 1 is the worst possible care and 10 is the best possible care. Mean scores are reported, and higher scores indicates more satisfaction with care."|Baseline and 6 and 12 months post randomization|Due to the small number of participants who withdrew, or were lost to follow up, the number of participants interviewed at 6 months and 12 months is lower than number at baseline.|||units on a scale||Standard Deviation|Mean
2589726|NCT02290223|Secondary|PHQ-9 Depression|Depression was measured using the Patient Health Questionnaire-9 (PHQ-9), a reliable and well validated instrument. Mean scores are reported in range 0-27, with higher score indicating severity of depression: mild (5-9), moderate (10-14), moderately severe (15-19) and over 20 indicating severe depression.|Baseline and 6 and 12 months post randomization|Due to the small number of participants who withdrew, or were lost to follow up, the number of participants interviewed at 6 months and 12 months is lower than number at baseline.|||score||Standard Deviation|Mean
2589727|NCT02290223|Secondary|Overall Health|"The Patient-Reported Outcome Measurement Information System (PROMIS) Global Health instrument is a system of highly reliable, and precise measures of patient-reported outcomes in physical and mental health and social well-being. Measure of overall health is based on a single item/rating: In general, would you say your health is:. Answers are reported on scale 1-5, with 1=poor to 5=excellent. Average raw scores are reported, with higher scores reflecting higher functioning."|Baseline and 6 and 12 months post randomization|Due to the small number of participants who withdrew, or lost to follow up, the number of participants interviewed at 6/12 months is lower than number at baseline.|||units on a scale||Standard Deviation|Mean
2589728|NCT02290223|Secondary|Quality of Life: Mental Health|The PROMIS Global Health score was used to assess general perceptions of health and quality of life. The 10 items that comprise the Quality of Life scale are reported as two dimensions, mental health and physical health. Raw scores for PROMIS Global Mental Health were converted to standardized T-scores using published conversion tables.T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score always represents more of the concept being measured. Thus, a person who has T-score of 60 is one standard deviation better (more healthy) than the general population.|Baseline and 6 and 12 months post randomization|Due to the small number of participants who withdrew, or were lost to follow up, the number of participants interviewed at 6 months and 12 months is lower than number at baseline.|||T score||Standard Deviation|Mean
2589729|NCT02290223|Secondary|Quality of Life: Physical Health|The PROMIS Global Health score was used to assess general perceptions of health and quality of life. The 10 items that comprise the Quality of Life scale are reported as two dimensions, mental health and physical health. Raw scores for PROMIS Global Physical Health were converted to standardized T-scores using published conversion tables.T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score always represents more of the concept being measured. Thus, a person who has T-score of 60 is one standard deviation better (more healthy) than the general population.|Baseline and 6 and 12 months post randomization|Due to the small number of participants who withdrew, or were lost to follow up, the number of participants interviewed at 6 months and 12 months is lower than number at baseline.|||T score||Standard Deviation|Mean
2589730|NCT02290223|Primary|Patient Activation|The Patient Activation Measure (PAM) is a 13-item instrument for measuring patient beliefs, knowledge and confidence for engaging in a wide range of health behaviors.Each item is rated 1-4 (strongly disagree =1 to strongly agree=4) and a total raw score is generated (0-52). Raw scores are converted to activation scores using a published conversion table. PAM scores are reported on a 1-100 scale, with higher scores associated with positive health outcomes such as participation in health care and treatment adherence.|Baseline and 6 and 12 months post randomization|Due to the small number of participants who withdrew, or were lost to follow up, the number of participants interviewed at 6 months and 12 months is lower than number at baseline.|||units on a scale||Standard Deviation|Mean
2589731|NCT02290184|Secondary|Change in Waist Circumference|Change in waist circumference over time within groups|baseline to 3 months|Multilevel regression used to analyze the within group change for waist circumference and cross-level interaction for between group change over time.|||centimeter||95% Confidence Interval|Mean
2589732|NCT02290184|Secondary|Percent Change in Weight (kg) From Baseline and 3 Months|100 x change in weight (kg) at 3 months divided by weight (kg) at baseline. Intervention group will have a significantly greater reduction in % weight change compared to the active control from baseline to 3-months.|Baseline to 3 months|Filipino American adults 18 years or older with overweight and Type 2 diabetes were randomized in a 1:1 ratio to either the Intervention or the Active Control group.|||percent change||95% Confidence Interval|Mean
2589733|NCT02290184|Secondary|Weight Change in Kilograms|weight change in kilograms over a 3 month period. Intervention group will have a significantly greater reduction in weight change compared to the active control from baseline to 3-months|Baseline to 3 months|English-speaking Filipino Americans adults 18 years or older with overweight and Type 2 diabetes were randomized in a 1:1 ratio to either the intervention or active control group.|||kilogram||95% Confidence Interval|Mean
2589734|NCT02290184|Primary|Feasibility for Participant Enrollment and Retention|Able to enroll at least 20 eligible participants per arm (measured by count), and retain at least 80% of enrolled participants in each arm|Baseline to 6-months|Total number of enrolled participants in each arm who completed 6-month program divided by the total number of enrolled participants in each arm. Goal is to retain 80% of participants enrolled in each arm.|||percentage of participants retained|participants||Number
2589735|NCT02290106|Secondary|Quantitative Insulin Sensitivity Check Index (QUICKI)|quantitative insulin sensitivity check index (QUICKI) at 6 months. Measure = 1/((log(glucose in mg/dL) + log(insulin in uU/mL))|6 months||||QUICKI index||Standard Deviation|Mean
2589736|NCT02290106|Secondary|Hemoglobin A1c (HbA1c)||6 months||||% (hemoglobin A1c)||Standard Deviation|Mean
2589737|NCT02290106|Secondary|Hepatic Insulin Sensitivity|"hepatic insulin sensitivity assessed by glucose infusion rate corrected for fluctuations in serum glucose (M) during low-dose insulin clamp"|6 months|all patients with available data at baseline and final (note, in addition to 3 patients who discontinued, some patients were unable to undergo clamp procedure)|||mg/kg/minute||Standard Deviation|Mean
2589747|NCT02289989|Primary|The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 25|"This was measured with two questions. The first one referred to the description of the lesion and it included six characteristics: clear, dry, scaly, redness, cracks/opening and oozing. The second questions asked to grade how itchy was the patient.~All characteristics were measured on a scale from 0 to 5 (0 none, 5 extremely bothered/losing sleep)."|From baseline to day 25||||participants|||Number
2589748|NCT02289963|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo A-1 ITT population.|||percent change||Standard Error|Least Squares Mean
2589749|NCT02289963|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 were obtained from multiple imputation approach followed by a robust regression model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2589750|NCT02289963|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2589751|NCT02289963|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12- ITT Analysis|Adjusted means and standard errors at Week 12 were obtained from multiple imputation approach followed by robust regression model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2589752|NCT02289963|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).|||percent change||Standard Error|Least Squares Mean
2589753|NCT02289963|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2589754|NCT02289963|Secondary|Percent Change From Baseline in High Density Lipoprotein (HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2589755|NCT02289963|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data up to Week 24 regardless of status on- or off-treatment were included in the imputation model.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2589756|NCT02289963|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-treatment Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.|||percentage of participants|||Number
2589757|NCT02289963|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data up to Week 24 regardless of status on- or off-treatment were included in the imputation model.|From Baseline to Week 24|ITT population.|||percentage of participants|||Number
2589758|NCT02289963|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
2589759|NCT02289963|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Non-HDL-C ITT population.|||percent change||Standard Deviation|Least Squares Mean
2589760|NCT02289963|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
2589761|NCT02289963|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).|||percent change||Standard Deviation|Least Squares Mean
2589762|NCT02289963|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).|||percent change||Standard Deviation|Least Squares Mean
2589905|NCT02289105|Secondary|Proportion of Participants Who Return a Signed AD|This measures the proportion of participants who return a signed and printed copy of their AD of those who completed an AD online.|Baseline - up to 1 year||||proportion of participants||95% Confidence Interval|Number
2589763|NCT02289963|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2589764|NCT02289963|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo B mITT population).|||percent change||Standard Error|Least Squares Mean
2589765|NCT02289963|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).|||percent change||Standard Error|Least Squares Mean
2589766|NCT02289963|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.|||percent change||Standard Error|Least Squares Mean
2589767|NCT02289963|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data up to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
2589768|NCT02289963|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data up to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population that included all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||Percent Change||Standard Error|Least Squares Mean
2589769|NCT02289963|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data up to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population that included all randomized participants with one baseline and at least one post-baseline calculated LDL-C on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2589770|NCT02289898|Primary|Hazard of Progression in the Placebo/Placebo Arm and the Pooled Demcizumab Arms|Investigator assessed Kaplan-Meier estimates of progression-free survival for placebo/placebo arm and pooled demcizumab arm.|Investigator-assessed progression-free survival time through duration of the study (2 years, 23 days).|Placebo/placebo arm and pooled demcizumab arms (ITT population).|||Participants|||Count of Participants
2589771|NCT02289833|Secondary|Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (ADAs)|The presence of ADAs in blood serum is an indication of the body's immune response to a drug.|Pre-dose (within 2 days) on Day 1 of Cycles 1 and 3; at treatment discontinuation/early termination,up to primary analysis, approx. 22 months|The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants with post-dose sample available for ADA analysis.|||percentage of participants|||Number
2589772|NCT02289833|Secondary|Maximum Observed Concentration (Cmax) for N2'- Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1)|Cmax is the maximum observed concentration of a drug and was measured in blood plasma.|Pre-dose (within 2 days) and 30 minutes (min) after end of infusion (infusion length= 100 min or less) on Day 1 of Cycle 1 (one cycle=21 days); at treatment discontinuation/early termination,up to primary analysis, approx. 22 months|The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2589773|NCT02289833|Secondary|Clearance (CL) for Trastuzumab Emtansine and Total Trastuzumab|CL is a measure of the body's elimination of a drug from blood serum over time.|Pre-dose & 30 minutes (min) post-infusion (inf.) on D 1 of C 1 & 3; post- inf. on D 2, 3, 4 or 5, 8, & 15 of C 1, & pre- inf. on D 1 of C 2 & D 1 of C 4 (C=21 days); at treatment discontin/early termination, up to primary analysis, approx. 22 months|The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants who consented to intense sampling.|||mL/day/kg||Standard Deviation|Mean
2589774|NCT02289833|Secondary|Volume of Distribution (Vss) for Trastuzumab Emtansine and Total Trastuzumab|Vss is the volume of distribution of study drug at steady state.|Pre-dose & 30 minutes (min) post-infusion (inf.) on D1 of C1 & 3; post- inf. on D2, 3, 4 or 5, 8, & 15 of C 1, & pre- inf. on D 1 of C 2 & D1 of C 4 (C=21 days); at treatment discontin/early termination, up to primary analysis, approx. 22 months|The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants who consented to intense sampling.|||milliliters kilogram (mL/kg)||Standard Deviation|Mean
2589795|NCT02289820|Secondary|Geometric Mean Fold Rises (GMFRs) of Serum Antibodies Against RSV by RSV A Microneutralization Assay|GMFRs of serum antibodies against RSV, as assessed by the RSV A microneutralization assay from Baseline line through Day 361 were presented. Humoral immunogenicity samples was used to assess RSV A neutralizing antibody. Humoral immunity against RSV was assessed by a microneutralization assay for RSV A.|Day 29, 61, 91, 181, 271, and 361|Immunogenicity Population. Here, ‘n’ is number of participants analyzed for this outcome measure at given time points.|||Fold rise||95% Confidence Interval|Geometric Mean
2589775|NCT02289833|Secondary|Elimination Half-Life (t1/2) for Trastuzumab Emtansine and Total Trastuzumab|t1/2 is the time required for the drug serum concentration to be reduced to half.|Pre-dose & 30 minutes (min) post-infusion (inf.) on D 1 of C 1 & 3; post- inf. on D 2, 3, 4 or 5, 8, & 15 of C 1, & pre- inf. on D 1 of C 2 & D 1 of C 4 (C=21 days); at treatment discontin./early termination, up to primary analysis, approx. 22 months|The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants who consented to intense sampling.|||days||Standard Deviation|Mean
2589776|NCT02289833|Secondary|AUCinf for Trastuzumab Emtansine and Total Trastuzumab|AUC (from zero to infinity) represents the total drug exposure over time in blood serum.|Pre-dose & 30 minutes (min) post-infusion (inf.) on Day (D) 1 of Cycles (C) 1 & 3; post- inf. on D 2, 3, 4 or 5, 8, & 15 of C 1, & pre- inf. on D1 of C2 & D1 of C 4 (C=21 D); at discontin./termination, up to primary analysis, approx. 22 months|The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants who consented to intense sampling.|||days times ug/mL (day* ug/mL)||Standard Deviation|Mean
2589777|NCT02289833|Secondary|Maximum Observed Concentration (Cmax) for Trastuzumab Emtansine and Total Trastuzumab|Cmax is the 0-21 day maximum observed concentration of a drug and was measured in blood serum.|Pre-dose (within 2 days) and 30 minutes (min) after end of infusion (infusion length= 100 min or less) on Day 1 of Cycles 1 and 3 (one cycle=21 days); at treatment discontinuation/early termination, up to primary analysis, approx. 22 months|The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants.|||micrograms per milliliter (ug/mL)||Standard Deviation|Mean
2589778|NCT02289833|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, whether or not considered related to the study drug. A SAE is any experience that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant.|From Day 1 to 30 days after last dose of study drug, up to the study completion date (approximately 43 months)|The safety-evaluable population included participants who received at least one dose of study treatment.|||percentage of participants|||Number
2589779|NCT02289833|Secondary|Percentage of Participants With Clinical Benefit as Per Investigator Assessment According to RECIST, v1.1|Clinical benefit is defined as having a CR or PR or stable disease (using RECIST, v1.1) at 6 months. Participants with no post-baseline response assessment are considered as experiencing no clinical benefit. CR: disappearance of all target lesions; and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum while in the study. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions.|From Day 1 to PD or death from any cause, up to the study completion date (approximately 43 months)|The efficacy-evaluable population included participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2589780|NCT02289833|Secondary|Duration of Objective Response (DOR) Assessed According to RECIST v1.1|DoR is defined as the time from the initial documentation of response (CR or PR using RECIST, v1.1) to documented disease progression using RECIST v1.1 or death from any cause during the study. CR: disappearance of all target lesions; and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions.|From first documented objective response to PD or death from any cause, up to the study completion date (approximately 43 months)|The efficacy-evaluable population included participants who received at least one dose of study drug. Data are reported for participants with response.|||months||95% Confidence Interval|Median
2589781|NCT02289833|Secondary|Percentage of Participants With DOR Event of Disease Progression, Assessed According to RECIST v1.1|DOR is defined as the time from the initial documentation of response (CR or PR using RECIST, v1.1) to documented disease progression using RECIST v1.1 or death from any cause during the study. CR: disappearance of all target lesions; and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions.|From first documented objective response to PD or death from any cause, up to the study completion date (approximately 43 months)|The efficacy-evaluable population included participants who received at least one dose of study drug. Data are reported for participants with response.|||percentage of participants|||Number
2589782|NCT02289833|Secondary|Progression-Free Survival (PFS) as Per Investigator Assessment According to RECIST v. 1.1|PFS is defined as the time from first study drug administration to first documented disease progression, based on investigator assessment using RECIST, v1.1, or death from any cause during the study, whichever occurs first. Disease progression is defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions.|From Day 1 to PD or death from any cause, up to the study completion date (approximately 43 months)|The efficacy-evaluable population included participants who received at least one dose of study drug. Data are reported for participants with events.|||months||95% Confidence Interval|Median
2589783|NCT02289833|Secondary|Percentage of Participants With PFS Event of Disease Progression, as Per Investigator Assessment According to RECIST v. 1.1, or Death|PFS is defined as the time from first study drug administration to first documented disease progression, based on investigator assessment using RECIST, v1.1, or death from any cause during the study, whichever occurs first. Disease progression is defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions.|From Day 1 to PD or death from any cause, up to the study completion date (approximately 43 months)|The efficacy-evaluable population included participants who received at least one dose of study drug.|||percentage of participants|||Number
2589784|NCT02289833|Secondary|Overall Survival (OS)|OS is defined as the time from first study drug administration to death from any cause.|From Day 1 to death from any cause, up to the study completion date (approximately 43 months)|The efficacy-evaluable population included participants who received at least one dose of study drug. Data are reported for participants with events.|||months||95% Confidence Interval|Median
2589785|NCT02289833|Secondary|Percentage of Participants Who Died||From Day 1 to death from any cause, up to the study completion date (approximately 43 months)|The efficacy-evaluable population included participants who received at least one dose of study drug. Data are reported for participants with events.|||percentage of participants|||Number
2589786|NCT02289833|Primary|Percentage of Participants With Objective Response as Per Investigator Assessment According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v. 1.1)|Objective response is defined as a complete response (CR) or partial response (PR) determined on two consecutive assessments ≥ 4 weeks apart, based on investigator assessment according to RECIST, Version 1.1. CR: disappearance of all target lesions; and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeters (mm). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Day 1 to disease progression (PD) or death from any cause, up to the clinical cutoff date (approximately 22 months)|The efficacy-evaluable population included participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2589787|NCT02289820|Secondary|Percentage of Participants With Post-dose Cell-mediated Immune Response to RSV F by RSV F Peptide Pool IFNγ ELISPOT|Seroresponse defined as a greater than or equal to (>=) 3-fold rise from baseline. The Cell-mediated immunity was assessed using an IFNγ ELISPOT assay to measure the T-cell responses to the RSV F peptide pool using thawed, cryopreserved peripheral blood mononuclear cell samples.|Day 8|Immunogenicity Population.|||Percentage of Participants||95% Confidence Interval|Number
2589788|NCT02289820|Secondary|GMFRs of Cellular Immune Response Against RSV by RSV F IFNγ ELISPOT Assay|The GMFRs assessed by the ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. Cell-mediated immunity was assessed using an IFNγ ELISPOT assay to measure the T-cell responses to the RSV F peptide pool using thawed, cryopreserved peripheral blood mononuclear cell samples|Day 8|Immunogenicity Population.|||Fold rise||95% Confidence Interval|Geometric Mean
2589789|NCT02289820|Secondary|Geometric Mean Counts of Cellular Immune Response Against RSV by Respiratory Syncytial Virus Fusion Protein (RSV F) Interferon Gamma (IFNγ) Enzyme-linked Immunosorbent Spot (ELISPOT) Assay|The Geometric Mean Counts assessed by the ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. Cell-mediated immunity was assessed using an IFNγ ELISPOT assay to measure the T-cell responses to the RSV F peptide pool using thawed, cryopreserved peripheral blood mononuclear cell samples.|Baseline (Day 1) and Day 8|Immunogenicity Population. Here, ‘n’ is number of participants analyzed for this outcome measure at given time points.|||Spot forming counts per 10^6 PBMCs||95% Confidence Interval|Geometric Mean
2589790|NCT02289820|Secondary|Ratios of GMTs and GMFRs of Hemagglutination Inhibition (HAI) Antibodies|The ratio of post-dose HAI antibody GMTs and GMFRs in the IIV group and the MEDI7510 plus IIV group was provided by strain and by cohort for Cohorts 2 and 3 to check the effect of MEDI7510 on IIV when administered together. Humoral immunity against influenza consisting of HAI antibody to strains antigenically matched to those contained in the IIV was assessed on Day 29 by each strain (H1N1, H3N2, B/Yamagata).|Day 29|Immunogenicity Population.|||Ratio||95% Confidence Interval|Number
2589791|NCT02289820|Secondary|Percentage of Participants With Post-dose Seroresponse to RSV by Anti-F IgG Assay|Seroresponse defined as a greater than or equal to (>=) 3-fold rise from baseline. Humoral immunity against RSV was assessed by an Anti-F IgG assay derived from the RSV-specific 4-plex MSD assay.|Day 29|Immunogenicity population.|||Percentage of Participants||95% Confidence Interval|Number
2589792|NCT02289820|Secondary|GMFRs of Serum Antibodies Against RSV by Anti F IgG Assay|The Anti F IgG antibodies were derived from the RSV-specific 4-plex MSD assay developed on the Meso Scale discovery platform. Humoral immunogenicity samples were used to assess anti-F IgG antibodies measured using a 4-plex Meso Scale Discovery (MSD) platform assay. Results through Day 361 are presented.|Day 29, 61, 91, 181, 271, and 361|Immunogenicity Population. Here, ‘n’ is number of participants analyzed for this outcome measure at given time points.|||Fold rise||95% Confidence Interval|Geometric Mean
2589793|NCT02289820|Secondary|Geometric Mean Concentrations of Serum Antibodies Against RSV by Anti F Immunoglobulin G (IgG) Assay|Humoral immunogenicity samples were used to assess anti-F IgG antibodies measured using a 4-plex Meso Scale Discovery (MSD) platform assay. Results through Day 361 are presented.|Baseline (Day 1), Day 29, 61, 91, 181, 271, and 361|Immunogenicity Population. Here, ‘n’ is number of participants analyzed for this outcome measure at given time points.|||F Ab Unit/mL||95% Confidence Interval|Geometric Mean
2589794|NCT02289820|Secondary|Percentage of Participants With Post-dose Seroresponse to RSV by RSV A Microneutralization Assay|Seroresponse defined as a greater than or equal to (>=) 3-fold rise in titer from baseline. Humoral immunogenicity samples was used to assess RSV A neutralizing antibody. Humoral immunity against RSV was assessed by a microneutralization assay for RSV A.|Day 29|Immunogenicity population.|||Percentage of Participants||95% Confidence Interval|Number
2589906|NCT02289105|Secondary|Proportion of Participants Who Already Have ADs||Baseline - up to 1 year||||proportion of participants|||Number
2589907|NCT02289105|Primary|Proportion of Participants That Select to Complete an Advance Directive|We will analyze the effects of the active choice intervention on rates of completion.|Baseline - up to 1 year||||proportion of participants||95% Confidence Interval|Number
2589796|NCT02289820|Secondary|Geometric Mean Titers (GMTs) of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay|GMTs of serum antibodies against RSV, as assessed by the RSV A microneutralization assay at Baseline and the results through Day 361 were presented. Humoral immunogenicity samples was used to assess RSV A neutralizing antibody. Humoral immunity against RSV was assessed by a microneutralization assay for RSV A. Immunogenicity population is defined as all participants in ATP who had no protocol deviation judged to have the potential to interfere with generation or interpretation of an immune response.|Baseline (Day 1), Day 29, 61, 91, 181, 271, and 361|Immunogenicity population|||Titers||95% Confidence Interval|Geometric Mean
2589797|NCT02289820|Primary|Percentage of Participants With Treatment-emergent Adverse Events of Special Interest (TEAESI)|An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. Treatment emergent AESIs were collected from the time of dosing through the day of the last participant contact (Day 361 visit).|From Day 1 to Day 361|ATP included all participants who received any amount of study drug.|||Percentage of Participants|||Number
2589798|NCT02289820|Primary|Percentage of Participants With New Onset Chronic Diseases (NOCDs)|A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving study drug and was assessed by investigator as medically significant. All NOCDs were recorded from the time of dosing through the day of the last participant contact (Day 361 visit).|From Day 1 to Day 361|ATP included all participants who received any amount of study drug.|||Percentage of Participants|||Number
2589799|NCT02289820|Primary|Percentage of Participants With Treatment-emergent Serious Adverse Events|A serious adverse event (SAE) was an AE resulting in any of following reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk), persistent or significant disability/incapacity, congenital anomaly, and a medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.|From Day 1 to Day 361|ATP included all participants who received any amount of study drug.|||Percentage of Participants|||Number
2589800|NCT02289820|Primary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Treatment-emergent were the events between administration of study drug and including the follow-up period through Day 29. The AEs were summarized using the Medical Dictionary for Regulatory Activities version 18.1.|From Day 1 to Day 29|ATP included all participants who received any amount of study drug.|||Percentage of Participants|||Number
2589801|NCT02289820|Primary|Percentage of Participants With Solicited Symptoms|Solicited symptoms are events that are considered likely to occur post dosing and included the local reaction (pain, tenderness or soreness, redness, and swelling at the site of injection) to investigational product (IP) injection and systemic symptoms (fever greater than or equal to [>=] 100.4°F [>=38°C] by any route, headache, generalized muscle aches, and fatigue or tiredness) that might be related to IP injection. Solicited symptoms were not coded using Medical Dictionary for Regulatory Activities (MedDRA) and summarized regardless of whether or not they are treatment emergent. The percentage of participants with solicited symptoms were recorded during Days 1 (day of dosing) through 7.|Day 1 to Day 7|As-treated Population (ATP) included all participants who received any amount of study drug.|||Percentage of Participants|||Number
2589802|NCT02289755|Secondary|Percent Change From Baseline Period to Treatment Period in 24-hour Urinary Oxalate Excretion|Percent Change from Baseline is defined as baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7) divided by baseline value times 100%|7 days|All Participants (N=16) were included in the analysis.|||percentage change||Standard Deviation|Mean
2589803|NCT02289755|Primary|Change From Baseline Period to Treatment Period 24-hour Urinary Oxalate Excretion|Change from Baseline is defined as Baseline value (average of Days 2 and 3) minus ALLN-177 treatment value (mean of Days 5, 6, and 7).|7 days|All Participants (N=16) completed treatment and were included in the analysis population.|||mg/day||Standard Deviation|Mean
2589804|NCT02289742|Secondary|Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear|A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.|Hour 8, each product|This analysis population includes all randomized and exposed subjects with data at visit.|||percentage of subjects|||Number
2589805|NCT02289742|Primary|Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear|A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.|Hour 12, each product|This analysis population includes all randomized and exposed subjects with data at visit.|||percentage of subjects|||Number
2589806|NCT02289729|Secondary|Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Month 6|"Spearman correlation statistics were calculated for the quality of life of the caregivers (Global SQLC, see Outcome Measure ) and the following scales: ZBI (see Outcome Measure 40), GADS-Anxiety (see Outcome Measure 43), and GADS-Depression (see Outcome Measure 42), NBL A-S (see Outcome Measure 22), NBL C-D (see Outcome Measure 23), NBL C-R (see Outcome Measure 24), Global PDQ-39 (see Outcome Measure 1), UPDRS-III (see Outcome Measure 10), UPDRS-IV (see description below), and Global NMSS (see Outcome Measure 11).~The UPDRS-IV contains 11 items, each scored in a Likert scale from 0 (normal) to 4 (severe); or a 2-point scale (yes/no format), with 1 point for yes and 0 for no. The global score was calculated summing the score of each item, ranging from 0 to 23, where higher scores are associated with more disability."|Month 6 (±15 days)|Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed Month 6 assessments.|||correlation coefficient|||Number
2589807|NCT02289729|Secondary|Correlation Between Caregivers' Quality of Life (SQLC) and Different Questionnaires at Baseline|"Spearman correlation statistics were calculated for the quality of life of the caregivers (Global SQLC, see Outcome Measure ) and the following scales: ZBI (see Outcome Measure 40), GADS-Anxiety (see Outcome Measure 43), and GADS-Depression (see Outcome Measure 42), NBL A-S (see Outcome Measure 22), NBL C-D (see Outcome Measure 23), NBL C-R (see Outcome Measure 24), Global PDQ-39 (see Outcome Measure 1), UPDRS-III (see Outcome Measure 10), UPDRS-IV (see description below), and Global NMSS (see Outcome Measure 11).~The UPDRS-IV contains 11 items, each scored in a Likert scale from 0 (normal) to 4 (severe); or a 2-point scale (yes/no format), with 1 point for yes and 0 for no. The global score was calculated summing the score of each item, ranging from 0 to 23, where higher scores are associated with more disability."|Baseline|Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline assessments.|||correlation coefficient|||Number
2589808|NCT02289729|Secondary|Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Month 6|"Spearman correlation statistics were calculated for the quality of life of the participants (Global PDQ-39, see Outcome Measure 1) and the following scales: UPDRS-III (see Outcome Measure 10), UPDRS-IV (see description below), NMSS (see Outcome Measure 11), BAI (see Outcome Measure 28), BDI-III (see Outcome Measure 27), AS (see Outcome Measure 26), PFS (see Outcome Measure 25), Norris Bond-Lader (NBL) Alertness-Sedation (A-S; see Outcome Measure 22), NBL Contented-Discontented (C-D; see Outcome Measure 23), NBL Calm-Relaxed (C-R; see Outcome Measure 24), ZBI (see Outcome Measure 40), GADS-Anxiety (see Outcome Measure 43), and GADS-Depression (see Outcome Measure 42).~The UPDRS-IV contains 11 items, each scored in a Likert scale from 0 (normal) to 4 (severe); or a 2-point scale (yes/no format), with 1 point for yes and 0 for no. The global score was calculated summing the score of each item, ranging from 0 to 23, where higher scores are associated with more disability."|Month 6 (±15 days)|Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and Month 6 assessments.|||correlation coefficient|||Number
2589809|NCT02289729|Secondary|Correlation Between Participants' Quality of Life (PDQ-39) and Different Questionnaires at Baseline|"Spearman correlation statistics were calculated for the quality of life of the participants (Global PDQ-39, see Outcome Measure 1) and the following scales: UPDRS-III (see Outcome Measure 10), UPDRS-IV (see description below), NMSS (see Outcome Measure 11), BAI (see Outcome Measure 28), BDI-III (see Outcome Measure 27), AS (see Outcome Measure 26), PFS (see Outcome Measure 25), Norris Bond-Lader (NBL) Alertness-Sedation (A-S; see Outcome Measure 22), NBL Contented-Discontented (C-D; see Outcome Measure 23), NBL Calm-Relaxed (C-R; see Outcome Measure 24), ZBI (see Outcome Measure 40), GADS-Anxiety (see Outcome Measure 43), and GADS-Depression (see Outcome Measure 42).~The UPDRS-IV contains 11 items, each scored in a Likert scale from 0 (normal) to 4 (severe); or a 2-point scale (yes/no format), with 1 point for yes and 0 for no. The global score was calculated summing the score of each item, ranging from 0 to 23, where higher scores are associated with more disability."|Baseline|Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline assessments.|||correlation coefficient|||Number
2589810|NCT02289729|Secondary|Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Caregiving|Activity impairment due to caregiving (the extent to which caregiving affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity/activity and 100% representing complete impact on productivity/activity.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||percentage of activity impairment||Standard Deviation|Mean
2589811|NCT02289729|Secondary|Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to Caregiving|The mean percentage of OWPI due to caregiving (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which caregiving decreased productivity (%)* [number of hours worked / (number of hours of work missed due to caregiving + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||percentage of overall work impairment||Standard Deviation|Mean
2589812|NCT02289729|Secondary|Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Caregiving (Presenteeism)|Presenteeism (the extent to which caregiving decreased productivity) is presented as the mean percentage of impairment while working due to caregiving, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||percentage of work impairment||Standard Deviation|Mean
2589813|NCT02289729|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) at Month 6|Absenteeism, presented as the mean percentage of work time missed due to caregiving (as reported on the WPAI), and calculated as: 100*number of hours of work missed due to caregiving / (number of hours of work missed due to caregiving + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||percentage of work time missed||Standard Deviation|Mean
2590078|NCT02287467|Secondary|Number of Patients Alive and Out of Hospital|Number and percent alive and out of hospital on day 28|Measured through Day 28|All participants with vital status known on Day 28|||Participants|||Count of Participants
2589814|NCT02289729|Secondary|Change From Baseline in Goldberg Anxiety and Depression Score (GADS): Anxiety Sub-Scale for Caregivers at Month 6|"The GADS is an 18-item self-report symptom inventory made up of two sub-scales, one for the detection of anxiety and another one for the detection of depression. Both sub-scales are composed of 9 questions. Answers are in yes/no format. Scoring is 1 point for each yes and 0 for each no, with a total sub-scale score of 0 (no anxiety/depression) to 9 (worst anxiety/depression). In the Spanish validation of GADS, the cutoff point to consider probable anxiety disorder is 4 and 2 for probable depression."|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589815|NCT02289729|Secondary|Change From Baseline in Goldberg Anxiety and Depression Score (GADS): Depression Sub-Scale for Caregivers at Month 6|"The GADS is an 18-item self-report symptom inventory made up of two sub-scales, one for the detection of anxiety and another one for the detection of depression. Both sub-scales are composed of 9 questions. Answers are in yes/no format. Scoring is 1 point for each yes and 0 for each no, with a total sub-scale score of 0 (no anxiety/depression) to 9 (worst anxiety/depression). In the Spanish validation of GADS, the cutoff point to consider probable anxiety disorder is 4 and 2 for probable depression."|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589816|NCT02289729|Secondary|Change From Baseline in the Caregiver Stress Index (CSI) at Month 6|"The CSI is a 13-item questionnaire based on identified common stressors. Answers are in yes/no format. Scoring is 1 point for each yes and 0 for each no. The total score is obtained by the sum of the scores of the items. Minimum score is 0 (no stress) and maximum score is 13 (most stress). A score ≥ 7 indicates a high level of stress."|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589817|NCT02289729|Secondary|Change From Baseline in Zarit Burden Interview (ZBI) at Month 6|The ZBI is a 22-item questionnaire in which caregivers must evaluate the level of agreement on a 5-point Likert scale from 0 to 4. The total score is obtained by the sum of the scores of the items. This total score represents a level of caregiver burden, with a range of 0 indicating no burden to 88 indicating completely overloaded.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589818|NCT02289729|Secondary|Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Caregiving Responsibilities at Month 6|The SQLC is designed to both qualitatively and quantitatively evaluate the impact of a patient's disease on the caregiver's quality of life. The SQLC questionnaire consists of 16 questions that evaluate 3 domains: professional activities (questions 1-4), social and leisure activities (questions 5-9), and caregiving responsibilities (questions 10-16). Caregiving responsibilities scores range from 0 to 53, with higher scores indicating higher quality of life.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589819|NCT02289729|Secondary|Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Social and Leisure Activities at Month 6|The SQLC is designed to both qualitatively and quantitatively evaluate the impact of a patient's disease on the caregiver's quality of life. The SQLC questionnaire consists of 16 questions that evaluate 3 domains: professional activities (questions 1-4), social and leisure activities (questions 5-9), and caregiving responsibilities (questions 10-16). Social and leisure activities scores range from 0 to 58, with higher scores indicating higher quality of life.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589820|NCT02289729|Secondary|Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Professional Activities at Month 6|The SQLC is designed to both qualitatively and quantitatively evaluate the impact of a patient's disease on the caregiver's quality of life. The SQLC questionnaire consists of 16 questions that evaluate 3 domains: professional activities (questions 1-4), social and leisure activities (questions 5-9), and caregiving responsibilities (questions 10-16). Professional activities scores range from 0 to 38, with higher scores indicating higher quality of life.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589821|NCT02289729|Secondary|Change From Baseline in the Scale of Quality of Life of Caregivers (SQLC) Composite Score at Month 6|The SQLC is designed to both qualitatively and quantitatively evaluate the impact of a patient's disease on the caregiver's quality of life. The SQLC questionnaire consists of 16 questions that evaluate 3 domains: professional activities (questions 1-4), social and leisure activities (questions 5-9), and caregiving responsibilities (questions 10-16). Composite scores range from 0 to 149, with higher scores indicating higher quality of life.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants (and caregivers) who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589822|NCT02289729|Secondary|Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Global Satisfaction at Month 6|The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total global satisfaction score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2590079|NCT02287467|Secondary|Mortality|Number of participants dying through day 28.|Measured through day 28|all participants|||Participants|||Count of Participants
2589823|NCT02289729|Secondary|Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Medical Care at Month 6|The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total medical care score ranging between 0 and 8, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589824|NCT02289729|Secondary|Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Impact on Daily Living Activities at Month 6|The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total impact on daily living activities score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589825|NCT02289729|Secondary|Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Convenience of Use at Month 6|The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total convenience of use score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589826|NCT02289729|Secondary|Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Treatment Effectiveness at Month 6|The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total treatment effectiveness score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589827|NCT02289729|Secondary|Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Undesirable Side Effects at Month 6|The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 4-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total undesirable side effects score ranging between 0 and 12, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589828|NCT02289729|Secondary|Change From Baseline in the Treatment Satisfaction With Medicines Questionnaire (SATMED-Q) Composite Score at Month 6|The SATMED-Q is a 17-item questionnaire. Items are grouped in 6 domains: undesirable side effects (items 1-3), treatment effectiveness (items 4-6), convenience of use (items 7-9), impact on daily living activities (items 10-12), medical care (items 13-14), and global satisfaction (items 15-17). Items are rated on a 5-point scale ranging from 0 to 4. Summing up the direct scores of the items yields a total composite score ranging between 0 and 68, which was transformed to a minimum of 0 (most satisfied) and a maximum of 100 (least satisfied).|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589829|NCT02289729|Secondary|Change From Baseline in Beck Anxiety Inventory (BAI) at Month 6|The BAI is a 21-item self-report multiple-choice inventory. Items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. Raw scores from 0-7 indicates minimal anxiety, 8-15 indicates mild anxiety, 16-25 indicates moderate anxiety, and 25-63 indicates severe anxiety.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589830|NCT02289729|Secondary|Change From Baseline in Beck Depression Inventory, Second Edition (BDI-II) at Month 6|The BDI-II is a 21-item self-report multiple-choice inventory. Items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63. Raw scores from 0-13 indicates minimal depression, 14-19 indicates mild depression, 20-28 indicates moderate depression, and 29-63 indicates severe depression.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589831|NCT02289729|Secondary|Change From Baseline in the Score of the Apathy Scale (AS) to Month 6|The AS is an inventory of 14 questions that assess cognitive and behavioral symptoms of emotional apathy. Each is rated from 0 to 3 on a Likert scale. The total scores for AS ranges from 0 (no apathy) to 42 (most apathetic). AS scores ≥ 14 were considered apathetic.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589832|NCT02289729|Secondary|Change From Baseline in Parkinson Fatigue Scale (PFS-16) at Month 6|The PFS-16 comprises 16 items with five polytomous response categories (strongly disagree, disagree, do not agree or disagree, agree, and strongly agree). Responses were scored from 0 (strongly disagree) to 4 (strongly agree), yielding a summed total score ranging from 0 (no fatigue) to 64 (most severe fatigue). The cut-point of ≥ 3.30 was used to identified those perceiving fatigue to be a problem.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589833|NCT02289729|Secondary|Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Calmness/Relaxation Sub-Scale Score at Month 6|The Norris/Bond-Lader VAS measures emotional well-being status with a 16-item visual analogue mood rating scale. The VAS consisted of 16 visual analogue items each representing opposite extremes of mood, with the following labels at each end: alert/drowsy, calm/excited, strong/weak, muzzy/clear-headed, well-coordinated/clumsy, lethargic/energetic, contented/dreamy, incompetent/proficient, happy/sad, antagonistic/amicable, interested/bored, withdrawn/gregarious. These scales loaded on 3 domains (alert, strong, clear-headed, well-coordinated, energetic, quick-witted, attentive, proficient, interested); (contented, tranquil, happy, amicable, gregarious); (calm, relaxed). For each individual scale, a line was drawn between each mood state and its opposite and participants rated their current mood by placing a vertical mark on the line. Scores (global, and for each domain) ranged from 0 to 100, with lower scores indicating more positive mood.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589834|NCT02289729|Secondary|Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Contented/Discontented Sub-Scale Score at Month 6|The Norris/Bond-Lader VAS measures emotional well-being status with a 16-item visual analogue mood rating scale. The VAS consisted of 16 visual analogue items each representing opposite extremes of mood, with the following labels at each end: alert/drowsy, calm/excited, strong/weak, muzzy/clear-headed, well-coordinated/clumsy, lethargic/energetic, contented/dreamy, incompetent/proficient, happy/sad, antagonistic/amicable, interested/bored, withdrawn/gregarious. These scales loaded on 3 domains (alert, strong, clear-headed, well-coordinated, energetic, quick-witted, attentive, proficient, interested); (contented, tranquil, happy, amicable, gregarious); (calm, relaxed). For each individual scale, a line was drawn between each mood state and its opposite and participants rated their current mood by placing a vertical mark on the line. Scores (global, and for each domain) ranged from 0 to 100, with lower scores indicating more positive mood.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589835|NCT02289729|Secondary|Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Alertness/Sedation Sub-Scale Score at Month 6|The Norris/Bond-Lader VAS measures emotional well-being status with a 16-item visual analogue mood rating scale. The VAS consisted of 16 visual analogue items each representing opposite extremes of mood, with the following labels at each end: alert/drowsy, calm/excited, strong/weak, muzzy/clear-headed, well-coordinated/clumsy, lethargic/energetic, contented/dreamy, incompetent/proficient, happy/sad, antagonistic/amicable, interested/bored, withdrawn/gregarious. These scales loaded on 3 domains (alert, strong, clear-headed, well-coordinated, energetic, quick-witted, attentive, proficient, interested); (contented, tranquil, happy, amicable, gregarious); (calm, relaxed). For each individual scale, a line was drawn between each mood state and its opposite and participants rated their current mood by placing a vertical mark on the line. Scores (global, and for each domain) ranged from 0 to 100, with lower scores indicating more positive mood.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589836|NCT02289729|Secondary|Change From Baseline in the Norris/Bond-Lader Visual Analogue Scale (VAS) Mean Global Score at Month 6|The Norris/Bond-Lader VAS measures emotional well-being status with a 16-item visual analogue mood rating scale. The VAS consisted of 16 visual analogue items each representing opposite extremes of mood, with the following labels at each end: alert/drowsy, calm/excited, strong/weak, muzzy/clear-headed, well-coordinated/clumsy, lethargic/energetic, contented/dreamy, incompetent/proficient, happy/sad, antagonistic/amicable, interested/bored, withdrawn/gregarious. These scales loaded on 3 domains (alert, strong, clear-headed, well-coordinated, energetic, quick-witted, attentive, proficient, interested); (contented, tranquil, happy, amicable, gregarious); (calm, relaxed). For each individual scale, a line was drawn between each mood state and its opposite and participants rated their current mood by placing a vertical mark on the line. Scores (global, and for each domain) ranged from 0 to 100, with lower scores indicating more positive mood.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589837|NCT02289729|Secondary|Change From Baseline in NMSS Miscellaneous Domain Score at Month 6|The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The miscellaneous domain score ranges from 0 to 48 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589868|NCT02289456|Secondary|Dose Intensity of Carboplatin During the Entire Study|Dose intensity for carboplatin during the entire study period was (mg*min/mL/week) = [cumulative dose for carboplatin in mg*min/mL] / [carboplatin dosing period in weeks].|From Day 1 of study treatment to end of study treatment; maximum treatment duration on study was 14.1 months|The treated population consisted of all participants who received at least 1 dose of investigational Product.|||mg*min/mL/week||Standard Deviation|Mean
2589838|NCT02289729|Secondary|Change From Baseline in NMSS Sexual Function Domain Score at Month 6|The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The sexual function domain score ranges from 0 to 24 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589839|NCT02289729|Secondary|Change From Baseline in NMSS Urinary Domain Score at Month 6|The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The urinary domain score ranges from 0 to 36 with a lower score indicating fewer symptoms.A negative change from baseline indicates improvement in symptoms.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589840|NCT02289729|Secondary|Change From Baseline in NMSS Gastrointestinal Tract Domain Score at Month 6|The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The gastrointestinal tract domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589841|NCT02289729|Secondary|Change From Baseline in NMSS Attention/Memory Domain Score at Month 6|The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The attention/memory domain score ranges from 0 to 36 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589842|NCT02289729|Secondary|Change From Baseline in NMSS Perceptual Problems/Hallucinations Domain Score at Month 6|The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The perceptual problems/hallucinations domain score ranges from 0 to 36 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589843|NCT02289729|Secondary|Change From Baseline in NMSS Mood/Cognition Domain Score at Month 6|The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The mood/cognition domain score ranges from 0 to 72 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589859|NCT02289456|Other Pre-specified|Percentage of Protocol Dose|The percentage of protocol specified dose administered during the induction and monotherapy periods. Percentage of protocol dose = (dose intensity / protocol weekly dose) * 100%; the protocol weekly dose of nab-paclitaxel is 66.67 mg/m2/week; the protocol weekly dose of carboplatin was 1.67 mg*min/mL/week.|From Day 1 of study drug treatment to end of study drug treatment; up to clinical data cut-off date of 24 February 2017; ; maximum treatment duration was 14.1 months.|The Treated Population consisted of all participants who received at least 1 dose of investigational product.|||Percentage of Protocol Dose||Full Range|Median
2590080|NCT02287467|Secondary|Hospital Discharge|Number of participants alive and discharged from the hospital|Measured through Day 7|All participants|||Participants|||Count of Participants
2589844|NCT02289729|Secondary|Change From Baseline in NMSS Sleep/Fatigue Domain Score at Month 6|The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The sleep/fatigue domain score ranges from 0 to 48 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589845|NCT02289729|Secondary|Change From Baseline in NMSS Cardiovascular Domain Score at Month 6|The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The cardiovascular domain score ranges from 0 to 24 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589846|NCT02289729|Secondary|Change From Baseline in the Non-Motor Symptom Scale (NMSS) Global Score at Month 6|The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular including falls (items 1-2), sleep/fatigue (items 3-6), mood/cognition (items 7-12), perceptual problems/hallucinations (items 13-15), attention/memory (items 16-18), gastrointestinal tract (items 19-21), urinary (items 22-24), sexual function (items 25-26), and miscellaneous (pain, taste/smell, weight change, excessive sweating; items 27-30). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent). The global score was calculated summing the score of each item (severity x frequency), ranging from 0 to 360, with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589847|NCT02289729|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale Part III (UPDRS-III): Motor Examination at Month 6|The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS-III was used in ON state. The motor examination contains 27 items. Each item is scored in a Likert scale from 0 to 4. The UPDRS-III score was calculated summing the score of each item, ranging from 0 to 108, with higher score indicating more impairment.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589848|NCT02289729|Primary|Change From Baseline in PDQ-39 Bodily Discomfort Domain Score at Month 6|The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The bodily discomfort domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589849|NCT02289729|Primary|Change From Baseline in PDQ-39 Communication Domain Score at Month 6|The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The communication domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589850|NCT02289729|Primary|Change From Baseline in PDQ-39 Cognition Domain Score at Month 6|The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The cognition domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589899|NCT02289157|Secondary|Number of Patients With Emergency Room Visits After Discharge|Number of emergency room visits made after initial discharge by the study (icNPT) and comparison groups.|Day of surgery to 30 days postoperative||||Participants|||Count of Participants
2589851|NCT02289729|Primary|Change From Baseline in PDQ-39 Social Support Domain Score at Month 6|The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The social support domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589852|NCT02289729|Primary|Change From Baseline in PDQ-39 Stigma Domain Score at Month 6|The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The stigma domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589853|NCT02289729|Primary|Change From Baseline in PDQ-39 Emotional Well-Being Domain Score at Month 6|The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The emotional well-being domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589854|NCT02289729|Primary|Change From Baseline in PDQ-39 Activities of Daily Living Domain Score at Month 6|The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The activities of daily living domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589855|NCT02289729|Primary|Change From Baseline in PDQ-39 Mobility Domain Score at Month 6|The PDQ-39 contains 39 items grouped in 8 domains: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (Likert scale): never, occasionally, sometimes, often, always or cannot do at all, scoring 0, 1, 2, 3 or 4, respectively. The mobility domain score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589856|NCT02289729|Primary|Change From Baseline in Parkinson's Disease Questionnaire-39 Item (PDQ-39) Global Score at Month 6|The PDQ-39 contains 39 items: mobility (items 1-10), activities of daily living (items 11-16), emotional well-being (items 17-22), stigma (items 23-26), social support (items 27-29), cognitions (items 30-33), communication (items 34-36), and bodily discomfort (items 37-39). Participants are asked to indicate the frequency of each event by selecting one of 5 options (score 0 to 4 on a Likert scale). The global score was calculated by expressing summed item scores as a percentage score ranging between 0 and 100. The lower scores indicate a better perceived health status and higher scores are associated with more health problems.|Baseline, Month 6 (±15 days)|Intent-to-Treat population: participants who received at least one dose of the study medication (LCIG) and completed baseline and end-of-treatment assessment.|||units on a scale||Standard Deviation|Mean
2589857|NCT02289469|Secondary|Patient Understanding|"Assessment of patient understanding of their medication regimen using 4 questions:~I understand what medicines I am supposed to take.~I understand how much medicine I am supposed to take at a time.~I understand what time of day to take each of my medicines.~I understand what each of my medicines is for. Participants had the following response options: Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree Due to formatting restrictions on this site and the results being nearly identical for each question, only answers to question 1 are reported below."|1 week|A convenience sample of 50 intervention patients was contacted by phone approximately 1 week after Emergency Department discharge to rate their understanding of their medication regimen.|||Participants|||Count of Participants
2589858|NCT02289469|Primary|Number of Participants With Changes/Updates in Medication List|Participants for whom nurses made updates or corrections to the medication history in electronic health record|1 day||||Participants|||Count of Participants
2603254|NCT02134119|Secondary|Hematological Measures - Ferritin|as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days||||ng/mL||Standard Deviation|Mean
2589860|NCT02289456|Secondary|Number of Participants With TEAEs During the Induction and Monotherapy Periods|Treatment-emergent adverse events were defined as any adverse event or serious adverse event that occurred or worsened on or after the day of the first dose of the IP through 28 days after the last dose of IP. In addition, any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. The severity of AEs were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild l intervention/therapy required Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.|From date of the first dose of IP until 28 days after the last IP dose and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; up to cutoff date of 24 Feb 2017; maximum treatment duration was 14.1 months|The Treated Population consisted of all participants who received at least 1 dose of IP.|||Participants|||Count of Participants
2589861|NCT02289456|Secondary|Kaplan Meier Estimate of Duration of Response|Duration of overall response was measured from the time measurement criteria were first met for CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions from baseline), whichever was first recorded, until the first date that recurrent disease or PD (at least a 20% increase in the sum of diameters of target lesions from nadir) was radiologically documented (taking as reference for PD the smallest measurements recorded on study). Median and 95% CI were estimated based on the Kaplan-Meier method.|From Day 1 of study drug treatment to the date of first occurrence of CR or PR; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months|Participants in the Treated population with a CR or PR. Participants who were non-responders (i.e., did not achieve at least a PR) were excluded from this analysis.|||Months||Full Range|Median
2589862|NCT02289456|Secondary|Time to Response|Time to response was defined as the time from Day 1 of study treatment to the first occurrence of response (CR or PR) according to RECIST v1.1 guidelines. RECIST V1.1 criteria includes: - A Complete Response (CR) is the disappearance of all target lesions; - A Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions from baseline|From Day 1 of study drug treatment to the date of first occurrence of CR or PR; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months|Treated Population; participants with a CR or PR|||Months||Full Range|Median
2589863|NCT02289456|Secondary|Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response According to RECIST 1.1 Guidelines|Overall tumor response is defined as the percentage of participants who achieved an objective confirmed CR (the disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions from baseline) according to RECIST V1.1 guidelines, compared with baseline where baseline was the last computed tomography (CT) scan obtained prior to or on Day 1 of study treatment.|Response assessments were evaluated every 2 cycles; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months|Participants who achieved a partial or complete response.|||Percentage of participants||95% Confidence Interval|Number
2589864|NCT02289456|Secondary|Kaplan Meier Estimate of Overall Survival (OS)|Overall survival was defined as the time in months between day 1 of treatment and death from any cause). Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.|From Day 1 of study treatment to death from any cause; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months|The Treated population consisted of all participants who received at least 1 dose of Investigational Product.|||months||95% Confidence Interval|Median
2589865|NCT02289456|Secondary|Percentage of Participants Who Achieved a Complete Response or Partial Response or Continued Stable Disease (Disease Control Rate)|Disease control rate was defined as the percentage of participants who had continued stable disease, complete or partial response during the course of the study, according to RECIST v1.1 guidelines, as evaluated by the investigator. RECIST V1.1 criteria includes: - Complete Response is the disappearance of all target lesions; - Partial Response is at least a 30% decrease in the sum of diameters of target lesions from baseline; - Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease; - Progressive Disease is at least a 20% increase in the sum of diameters of target lesions from nadir|Response assessments were evaluated every 6 weeks; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months|The Treated population consisted of all participants who received at least 1 dose of IP|||Percentage of Participants||95% Confidence Interval|Number
2589866|NCT02289456|Secondary|Kaplan Meier Estimate of Progression-Free Survival (PFS)|Progression-free survival was defined as the time in months from day 1 of treatment to the date of disease progression based on the investigator's assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred earlier. RECIST V1.1 criteria includes: - Complete Response (CR) is the disappearance of all target lesions; - Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions from baseline; - Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease (PD); - Progressive Disease is at least a 20% increase in the sum of diameters of target lesions from nadir|From Day 1 of study drug treatment to the date of disease progression; up to the clinical cut-off date of 24 February 2017; maximum treatment duration on study was 14.1 months|The treated Population consisted of all participants who received at least 1 dose of investigational product.|||months||95% Confidence Interval|Median
2589867|NCT02289456|Secondary|Percentage of Participants With Dose Reductions During the Entire Study|A dose reduction occurs when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions are typically caused by clinically significant laboratory abnormalities and/or treatment emergent adverse events or toxicities.|From day 1 of IP until 28 days after the last dose of IP; maximum treatment duration was 14.1 months during the entire study|The treated population consisted of all participants who received at least 1 dose of Investigational Product.|||Percentage of Participants|||Number
2589900|NCT02289157|Secondary|Length of Stay After Readmission|Number of days in hospital after readmission for wound morbidity|After dismissal and readmitted within 30 days for wound morbidity||||days||Inter-Quartile Range|Median
2589869|NCT02289456|Secondary|Dose Intensity of Nab-Paclitaxel During the Entire Study|Dose intensity for nab-paclitaxel during the entire study period was (mg/m^2/week) = [cumulative dose for nab-paclitaxel in mg/m^2] / [nab-paclitaxel dosing period in weeks]|From Day 1 of study treatment to end of study treatment; maximum treatment duration on study was 14.1 months|The treated population consisted of all participants who received at least 1 dose of Investigational Product.|||mg/m^2/week||Standard Deviation|Mean
2589870|NCT02289456|Secondary|Percentage of Participants Who Discontinued Study Treatment During the Induction Period (Discontinuation Rate)|Discontinuation Rate was measured as Percentage of Participants who Discontinued Study Treatment During the Induction Period|From date of the first dose of IP until 28 days after the last dose of IP during induction and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; maximum treatment duration during induction was 3.9 months|The Treated population consisted of all participants who received at least 1 dose of Investigational Product.|||Percentage of Participants|||Number
2589871|NCT02289456|Primary|Percentage of Participants Who Discontinued Study Treatment During the Induction Period Due to Treatment Emergent Adverse Events (TEAEs).|Treatment-emergent adverse events were defined as any adverse event (AE) or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the investigational product through 28 days after the last dose of IP. In addition, any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. A participant met the primary endpoint if: an AE was the reason for discontinuation as recorded in the electronic Case Report Form (eCRF) and the participant had no doses administered beyond Cycle 4. 95% confidence interval for the percentage was calculated using the Clopper Pearson method.|From date of the first dose of IP until 28 days after the last dose of IP during induction and SAEs made known to the investigator any time thereafter that are suspected of being related to IP; maximum treatment duration during induction was 3.9 months|The Treated population consisted of all participants who received at least 1 dose of Investigational Product.|||Percentage of Participants||95% Confidence Interval|Number
2589872|NCT02289417|Secondary|The Number of Participants Who Experienced TEAEs During Week 52 to Week 104 (Extension Phase)|A TEAE was defined as any AE occurring or worsening on or after the first treatment of apremilast and up to 28 days after the last apremilast dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain|From the first dose of IP at Week 52 and no later than 28 days after the last dose of IP for those who completed the study or had discontinued early; median exposure of apremilast for the total apremilast group was 52 weeks.|Participants who received at least 1 dose of apremilast after week 52.|||Participants|||Count of Participants
2589873|NCT02289417|Secondary|The Number of Participants Who Experienced TEAEs During the Apremilast (APR) Exposure Period (Active Treatment Phase) Through Week 52|A TEAE was defined as any AE occurring or worsening on or after the first treatment of apremilast and up to 28 days after the last apremilast dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain|From first dose of IP and no later than 28 days after last dose of IP for those who completed the active treatment phase or D/C early; median duration of exposure = 41.00, 44.15 and 40.00 weeks respectively for 30 mg, 40 mg and 30 mg/40 mg APR arms|Apremilast exposure population included all participants who were randomized at Week 0 or assigned at Week 12 to an apremilast group and received at least 1 dose of apremilast.|||Participants|||Count of Participants
2589874|NCT02289417|Secondary|The Number of Participants Who Discontinued Apremilast Due to Treatment Emergent Adverse Events During the Placebo-Controlled Period|A TEAE was defined as any AE occurring or worsening on or after the first treatment of apremilast and up to 28 days after the last apremilast dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain.|From the first dose of IP and no later than 28 days after the last dose of IP for those who had completed the study or discontinued early; median duration of exposure to treatment was 12.00 weeks|Safety population included all participants who were enrolled and received at least 1 dose of investigational product.|||Participants|||Count of Participants
2589875|NCT02289417|Secondary|The Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase|A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of apremilast and up to 28 days after the last apremilast dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain|From the first dose of investigational product (IP) and no later than 28 days after the last dose of IP for those who had completed the study or discontinued (D/C) early; maximum duration of exposure to treatment was 12.00 weeks|Safety population included all participants who were enrolled and received at least 1 dose of investigational product.|||Participants|||Count of Participants
2589876|NCT02289417|Secondary|Percentage of Participants Who Achieved Clinical Response in the Partial Mayo Subscore at Week 8|"Clinical response in the PMS was defined as a decrease from baseline in PMS of at least 2 points and at least 25%, with an accompanying decrease in the RBS of at least 1 point or an absolute RBS of 0 or 1. The PMS score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease).~Two-sided 95% CI for the within-group proportions are based on the Wilson score method."|Week 8|The intent to treat population included all participants who received at least one dose of IP. Participants with insufficient data for response determination were considered non-responders.|||Percentage of Participants||95% Confidence Interval|Number
2589877|NCT02289417|Secondary|Percentage of Participants Who Achieved Clinical Remission in the Partial Mayo Subscore (PMS) With no Individual Subscore >1 at Week 8|"Clinical remission in the partial Mayo subscore was defined as a PMS of 2 points or lower, with no individual subscore >1. The PMS is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores:~Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease).~Two-sided 95% CI for the within-group proportions are based on the Wilson score method."|Week 8|The intent to treat population included all participants who received at least one dose of IP. Participants with insufficient data for response determination were considered non-responders.|||Percentage of Participants||95% Confidence Interval|Number
2589878|NCT02289417|Secondary|Percentage of Participants Who Achieved Clinical Response in the Modified Mayo Subscore (MMS) at Week 12|"Clinical response in the MMS was defined as a decrease from baseline in the MMS of at least 2 points and at least 25%, along with a reduction in the RBS of at least 1 point or an absolute RBS ≤ 1. The MMS was based on the stool frequency, rectal bleeding, and endoscopic subscores of the TMS and excluded the PGA subscore. The MMS ranges from 0 to 9 points with higher scores indicating greater disease severity.~The RBS was measured as:~0 = No blood seen~= Streaks of blood with stool less than half the time~= Obvious blood with stool most of the time~= Blood alone passes~The daily bleeding score represents the most severe bleeding of the day. The endoscopy subscores was centrally reviewed. Two-sided confidence intervals for the within-group percentage were based on the Wilson score method."|Week 12|The intent to treat population included all participants who received at least one dose of IP. Participants with insufficient data for response determination were considered non-responders.|||Percentage of Participants||95% Confidence Interval|Number
2589879|NCT02289417|Secondary|Percentage of Participants Who Achieved Clinical Remission in the Modified Mayo Subscore (MMS) at Week 12|Clinical remission was defined as a modified Mayo score of ≤ 2, with no individual subscore > 1, at Week 12. The MMS was based on a modification of the total Mayo score (TMS) which included the stool frequency, rectal bleeding, and endoscopic subscores of the TMS and excluded the Physician's Global Assessment (PGA) subscore, since this was a global measure that is subjective in nature. The MMS ranges from 0 to 9 points with higher scores indicating greater disease severity. The endoscopy subscores was centrally reviewed. Two-sided confidence intervals for the within-group percentage were based on the Wilson score method.|Week 12|The intent to treat population included all participants who received at least one dose of IP. Participants with insufficient data for response determination were considered non-responders.|||Percentage of Participants||95% Confidence Interval|Number
2589880|NCT02289417|Secondary|Percentage of Participants Who Achieved a Rectal Bleeding Subscore (RBS) of ≤ 1 at Week 12|"The RBS was measured as:~0 = No blood seen~= Streaks of blood with stool less than half the time~= Obvious blood with stool most of the time~= Blood alone passes~The daily bleeding score represents the most severe bleeding of the day. Two-sided 95% CI for the within-group proportions are based on the Wilson score method."|Week 12|The intent to treat population included all participants who received at least one dose of IP. Participants with insufficient data for response determination were considered non-responders.|||Percentage of Participants||95% Confidence Interval|Number
2589881|NCT02289417|Secondary|Percentage of Participants Who Achieved an Endoscopic Response at Week 12|"An endoscopic response is defined as a decrease from baseline of at least 1 point in the MES at Week 12. The Mayo endoscopy subscore findings were defined as:~0 = Normal or inactive disease~= Mild Disease (erythema, decreased vascular pattern, mild friability)~= Moderate Disease (marked erythema, lack of vascular pattern, friability erosions) 3 = Severe Disease (spontaneous bleeding, ulceration).~The endoscopy subscores consisted of findings that were centrally read through proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease. Two-sided 95% CIs for the within-group percentage were based on the Wilson score method."|Week 12|The intent to treat population included all participants who received at least one dose of IP. Participants with insufficient data for response determination were considered non-responders.|||Percentage of Participants||95% Confidence Interval|Number
2589882|NCT02289417|Secondary|Percentage of Participants Who Achieved an Endoscopic Remission at Week 12|"An endoscopic remission was defined as a Mayo endoscopic subscore (MES) of 0 at Week 12.~The MES subscore findings were defined as:~0 = Normal or inactive disease~= Mild Disease (erythema, decreased vascular pattern, mild friability)~= Moderate Disease (marked erythema, lack of vascular pattern, friability erosions)~= Severe Disease (spontaneous bleeding, ulceration)~The endoscopy subscores consisted of findings that were centrally read through proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease. Two-sided 95% CIs for the within-group percentage were based on the Wilson score method."|Week 12|The intent to treat population included all participants who received at least one dose of IP. Participants with insufficient data for response determination were considered non-responders.|||Percentage of Participants||95% Confidence Interval|Number
2589901|NCT02289157|Secondary|Length of Postoperative Stay|Number of Days in Hospital after Initial Surgery|Length of Postoperative Stay||||days||Inter-Quartile Range|Median
2589902|NCT02289157|Primary|Number of Participants With Classification of Wound Morbidity|Listing of different types of wound morbidity in the 2 cohorts: dehiscence, cellulitis, superficial SSI, deep SSI, organ space SSI|Day of Surgery to 30 days postoperative||||Participants|||Count of Participants
2589903|NCT02289157|Primary|Number of Participants With Wound Complication|Number of Patients with Wound infection complications: hematoma, seroma, dehiscence, or Surgical Site Infection.|Day of surgery to 30 days postoperative||||Participants|||Count of Participants
2589904|NCT02289105|Other Pre-specified|Participant Selections on ADs and Declination Forms||Baseline - up to 1 year|||||||
2589883|NCT02289417|Secondary|Percentage of Participants Who Achieved a Clinical Response by Total Mayo Score and the Reduction in the Rectal Bleeding Subscore at Week 12|"Clinical response was defined as a decrease from baseline in the TMS of at least 3 points and at least 30%, along with a reduction in the rectal bleeding subscore (RBS) of at least 1 point or an absolute RBS of ≤ 1. The TMS is an instrument designed to measure disease activity of UC. The Mayo score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease.~Stool Frequency Subscore (SFS)~Rectal Bleeding Subscore~Endoscopy Subscore~Physician's Global Assessment (PGA)~Rectal bleeding (subscore 0-3) was defined as:~0 = No blood seen~= Streaks of blood with stool less than half the time~= Obvious blood with stool~= Blood alone passes Two-sided 95% CI for the within-group percentages are based on the Wilson score method."|Week 12|The intent to treat (ITT) population included all participants who received at least one dose of IP. Participants with insufficient data for response determination were considered non-responders.|||Percentage of Participants||95% Confidence Interval|Number
2589884|NCT02289417|Primary|Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score (TMS) at Week 12|"Clinical remission was defined as a total Mayo score ≤ 2 points, with no individual subscore exceeding 1 point. The TMS is an instrument designed to measure disease activity of UC. The Mayo score ranges from 0 to 12 points. It consists of 4 subscores, each graded from 0 to 3 with higher scores indicating more severe disease.~Stool Frequency Subscore (SFS)~Rectal Bleeding Subscore (RBS)~Endoscopy Subscore~Physician's Global Assessment (PGA). Two-sided 95% confidence intervals (CI) for the within-group percentages are based on the Wilson score method."|Week 12|The intent to treat (ITT) population included all participants who received at least one dose of IP. Participants with insufficient data for response determination were considered non-responders.|||Percentage of Participants||95% Confidence Interval|Number
2589885|NCT02289352|Secondary|Percentage of Patients With a Clinical Response of Treatment Success on Day 1||1 day||||percentage of participants|||Number
2589886|NCT02289352|Primary|Primary: Percentage of Treatment Success on Day 7|Percentage of patients with a clinical response of treatment success on Day 7 (± 1). Treatment success is defined as at least a 2-grade improvement on both CEA and PSA scores from baseline (pre-dose) on Day 7 (± 1) to 6 hours post-application on Day 7 (± 1).|7 days|Participants in the mITT Population that were evaluated for percentage of treatment successes.|||percentage of participants|||Number
2589887|NCT02289222|Secondary|Time to Progression Free Survival (PFS)|PFS will be measured in all participants. Survival and PFS functions were estimated using the Kaplan-Meier method. The Cox regression model was used to assess the following plausible risk factors for OS and PFS: age, isotype, number of cycles of therapy, and cytogenetic profile.|PFS assessments will take place after starting study therapy with MD-3475 and will continue until the start of a new anti-neoplastic therapy, disease progression, death, or the end of study up to an average of 24 months.||||Months||95% Confidence Interval|Median
2589888|NCT02289222|Secondary|PD-LI Expression On Myeloma Cells|The identification of a biomarker for response by evaluating PD-1/PDL-1 expression in patients' bone marrow aspirate samples will be analyzed in order to help select patients for future anti-PD-1 therapy. The main exploratory biomarker analysis was to examine potential correlation between expression of PD-1 on T cells and PD-L1 on myeloma cells with clinical outcome using the following parameters: response rate focusing on responses ≥ very good partial response (VGPR) and PFS. SAS software (v.9.4; SAS Institute, Inc, Cary, NC) was used for statistical analyses.|Tissue sample collection will take place before starting study therapy with MK-3475 at baseline and again at time of relapse as defined by the International Myeloma Working Group Response Criteria (Average of up to 24months)|Data were analyzed for 29 samples.|||Participants|||Count of Participants
2589889|NCT02289222|Primary|The Number of Participants With Adverse Events|Establish the safety and tolerability of Pomalidomide and Dexamethasone in combination with MK-3475|24 month||||Participants|||Count of Participants
2589890|NCT02289157|Secondary|Number of Patients With Chorioamnionitis Versus no Chorioamnionitis|Cochran-Mantel-Haenzel measure used to estimate interaction between chorioamnionitis and no chorioamnionitis stratified by icNPT and standard dressing, for wound morbidity|Day of Surgery to 30 days postoperative||||Participants|||Count of Participants
2589891|NCT02289157|Secondary|Number of Patients With Insulin Requiring Diabetes Versus no Insulin Requiring Diabetes|Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard wound dressings stratified by women with insulin requiring diabetes and no insulin requiring Diabetes.|Day of Surgery to 30 days postoperative||||Participants|||Count of Participants
2589892|NCT02289157|Secondary|Number of Patients With Hypertension Versus no Hypertension|Cochran-Mantel-Haenzel measure used to compare interaction between patients with hypertension versus no hypertension stratified by icNPT versus standard dressing, in wound morbidity|Day of Surgery to 30 days postoperative||||Participants|||Count of Participants
2589893|NCT02289157|Secondary|Number of Patients in Labor Versus no Labor Prior to Cesarean Section|Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard dressing stratified by patients in labor and patients not in labor|Day of Surgery to 30 days postoperative||||Participants|||Count of Participants
2589894|NCT02289157|Secondary|Number of Patients With Ruptured and Unruptured Membranes Prior to Cesarean Section|Cochran-Mantel-Haenzel measure used to compare interaction in icNPT and Standard dressing stratified by Ruptured vs Unruptured membranes|Day of Surgery to 30 days postoperative||||Participants|||Count of Participants
2589895|NCT02289157|Secondary|Number of Participants With Pfannenstiel Versus Midline Abdominal Incisions for Cesarian Section|Cochran-Mantel-Haenzel test for interactions between pfannenstiel and midline abdominal incisions stratified by icNPT vs Standard dressing, for wound morbidity|Day of Surgery to 30 days postoperative||||Participants|||Count of Participants
2589896|NCT02289157|Secondary|Number of Participants With Scheduled and Unscheduled Cesarean Section|Cochran Mantel-Hanzel measures used to compare interactions between scheduled and unscheduled cesarean sections stratified by icNPT and standard dressing, for wound morbidity|Day of Surgery to 30 days postoperative||||Participants|||Count of Participants
2589897|NCT02289157|Secondary|Number of Participants With Morbid Outcomes After Delivery||Day of Surgery to 30 days postoperative||||Participants|||Count of Participants
2589898|NCT02289157|Secondary|Number of Patients With Number of Clinic Visits|Number of clinic visits made by patients after surgery concerning wound morbidity per patient|Day of surgery to 30 days postoperative||||participants|||Number
2589908|NCT02289079|Secondary|Patient Satisfaction as Assessed Via Patient Survey|To determine if liposomal bupivacaine improves quality of recovery post-operatively when compared to bupivacaine when injected in a TAP block via a patient survey either in person or via telephone.|assessed at 72 hours after injection||||participants satisfied with pain control|||Number
2589909|NCT02289079|Secondary|Post Operative Length of Stay|To determine if liposomal bupivacaine provides decreased length of stay when compared to bupivacaine when injected in a TAP block|up to 30 days after surgery||||Hours||Standard Deviation|Mean
2589910|NCT02289079|Secondary|Numerical Rating Scale|This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.|48-72 hours||||scores on a scale||Full Range|Median
2589911|NCT02289079|Primary|Post Operative Opioid Use|To determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block|0-72 hours after injection||||micrograms of fentanyl equivalents||Full Range|Median
2589912|NCT02288819|Other Pre-specified|NYHA Functional Class|The patient is contacted by phone 30 days after baseline and NYHA functional class is assessed by a study investigator.|30 days after baseline|||||||
2589913|NCT02288819|Other Pre-specified|Self-reported Lower Leg Edema|The patient is contacted by phone 30 days after baseline and asked for self-reported presence of lower leg edema.|30 days after baseline|||||||
2589914|NCT02288819|Other Pre-specified|Self-reported Orthopnea|The patient is contacted by phone 30 days after baseline and asked for self-reported orthopnea.|30 days after baseline|||||||
2589915|NCT02288819|Other Pre-specified|Weight Change|Weight change [kg] 7 days after baseline compared to baseline weight.|7 days after baseline|||||||
2589916|NCT02288819|Other Pre-specified|Dose Increase of Loop Diuretics|Dose increase of oral maintenance therapy with loop diuretics compared to the final dose achieved in the study 7 days after baseline.|6 months after baseline|||||||
2589917|NCT02288819|Other Pre-specified|Rehospitalization for Heart Failure|Unplanned hospital admission for symptoms of congestion and/or low output heart failure requiring either intravenous therapy and/or increase of oral diuretics.|6 months after baseline|||||||
2589918|NCT02288819|Other Pre-specified|All-cause Mortality||6 months after baseline|The study was terminated after every participant reached the 30-day follow-up point because of slow recruitment and a lack of funding to complete further follow-up||||||
2589919|NCT02288819|Other Pre-specified|New York Heart Association (NYHA) Functional Class|"NYHA class is a semi-quantitative measurement of functional capacity on a scale from 1 to 4:~No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).~Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).~Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.~Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.~For the purpose of this outcome parameter, the patient is contacted by phone 30 days after baseline and NYHA functional class is assessed by a study investigator."|30 days after baseline|1 patient who died before the 30-day follow-up could not be assessed|||units on a scale from 1 to 4||Standard Deviation|Mean
2589920|NCT02288819|Other Pre-specified|Self-reported Lower Leg Edema|The patient is contacted by phone 30 days after baseline and asked for self-reported presence of lower leg edema.|30 days after baseline|1 patient who died before the 30-day follow-up could not be assessed|||Participants|||Count of Participants
2589921|NCT02288819|Other Pre-specified|Self-reported Orthopnea|The patient is contacted by phone 30 days after baseline and asked for self-reported orthopnea.|30 days after baseline|1 patient who died before the 30-day follow-up could not be assessed|||Participants|||Count of Participants
2589922|NCT02288819|Other Pre-specified|Weight Change|Weight change [kg] 30 days after baseline compared to weight 7 days after baseline (after achieving the final dose of loop diuretics).|30 days after baseline||||kg||Standard Deviation|Mean
2589923|NCT02288819|Secondary|Weight Change|Weight change [kg] 7 days after baseline compared to baseline weight.|7 days after baseline||||kg||Standard Deviation|Mean
2589924|NCT02288819|Secondary|Number of Participants Requiring a Dose Increase in Loop Diuretics|Dose increase of oral maintenance therapy with loop diuretics compared to the final dose achieved in the study 7 days after baseline.|30 days after baseline||||Participants|||Count of Participants
2589925|NCT02288819|Secondary|Number of Participants Rehospitalized for Heart Failure|Unplanned hospital admission for symptoms of congestion and/or low output heart failure requiring either intravenous therapy and/or increase of oral diuretics.|30 days after baseline||||Participants|||Count of Participants
2589926|NCT02288819|Secondary|All-cause Mortality||30 days after baseline||||Participants|||Count of Participants
2589927|NCT02288819|Primary|Number of Participants With Successful Downtitration of Loop Diuretics (no Weight Increase >1,5 kg)|After baseline evaluation, loop diuretics are temporarily downtitrated or stopped for 7 consecutive days. The patient is instructed to measure his/her weight in the morning of these days, immediately after waking up, on the same balance. In case of weight increase >1,5 kg, the original dose of diuretics is restored. To check this, patients are contacted by phone after 3 and 7 days. If the patient has not gained >1,5 kg of weight after 7 days, loop diuretics are considered to be successfully downtitrated.|7 days after baseline||||Participants|||Count of Participants
2589928|NCT02288559|Secondary|Percentage of Participants With Anti-Lampalizumab Antibodies|Having treatment-induced anti-drug antibodies (ADAs) was defined as being ADA-negative at baseline and ADA-positive at any post-baseline timepoint. Having treatment-enhanced ADAs was defined as being ADA-positive at baseline with titer values increased by 0.6 titer units at any post-baseline timepoint.|Baseline up to approximately 30 weeks|Safety analysis population included all randomized participants who received at least one dose of study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of participants|||Number
2590027|NCT02287636|Secondary|SUVs Using PET/MRI|The means and standard deviations of SUVs will be obtained and compared between PET/MRI and PET/CT using a two-sided two-sample t-test.|1 day|Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible.||||||
2589929|NCT02288559|Secondary|Percentage of Participants With Systemic (Non-ocular) Adverse Events|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Non-ocular AEs were the systemic events.|Baseline up to approximately 30 weeks|Safety analysis population included all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
2589930|NCT02288559|Secondary|Percentage of Participants With Ocular Adverse Events (AEs)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.|Baseline up to approximately 30 weeks|Safety analysis population included all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
2589931|NCT02288559|Secondary|Serum Concentrations of Lampalizumab (Q4W)|LTR results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of LLOQ (0.5 ng/mL).|Baseline (Day 1, predose and postdose), Weeks 4,8,16 and 24, early termination|PK population included participants randomized to lampalizumab treatment who received at least one dose of study drug and provided at least one serum sample for determination of lampalizumab. Number analyzed is the number of participants with data available for analysis at the given time-point.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2589932|NCT02288559|Secondary|Serum Concentrations of Lampalizumab (Q2W)|Lower than reportable (LTR) results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of lower limit of quantification (LLOQ) (0.5 nanograms per milliliter (ng/mL)).|Baseline (Day 1, predose and postdose), Weeks 2,4,8,16 and 24, early termination, unscheduled predose and postdose|Pharmacokinetics (PK) population included participants randomized to lampalizumab treatment who received at least one dose of study drug and provided at least one serum sample for determination of lampalizumab. Number analyzed is the number of participants with data available for analysis at the given time-point.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2589933|NCT02288559|Primary|Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluorescence (FAF) at Week 24|GA or the death of photoreceptors and surrounding cells in the retina, is a common condition in participants with age-related macular degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Scale.|Baseline, Week 24|Modified intent-to-treat (mITT) population included participants who were randomly assigned to study treatment and had at least one post-baseline GA area measurement. Number analyzed is the number of participants with data available for analysis at the given time-point.|||mm^2||Standard Error|Mean
2589934|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately on completion of the final core biopsy specimen, within approximately 20 minutes of starting|Data not collected at this time point.||||||
2589935|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately after obtaining the first core biopsy specimen, within approximately 15 minutes of starting|Data not collected at this time point.||||||
2589936|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately prior to obtaining the first core biopsy specimen, within approximately 15 minutes of starting|Data not collected at this time point.||||||
2589937|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|30 seconds after initiating deep injection of the parenchyma (deeper breast tissue), within approximately 4 minutes of starting|Data not collected at this time point.||||||
2589938|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|"immediately prior to injection of deep anesthesia in the breast parenchyma, within approximately 4 minutes of starting"|Data not collected at this time point.||||||
2589939|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|30 seconds after initiating superficial injection in the subcutaneous tissue, within approximately 1 minute of starting|Data not collected at this time point.||||||
2589940|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately on completion of the biopsy, within approximately 20 minutes of starting||||units on a scale||Standard Deviation|Mean
2589941|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately on completion of anesthetizing the parenchyma (deeper breast tissue), within approximately 4 minutes of starting||||units on a scale||Standard Deviation|Mean
2589942|NCT02288364|Secondary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately on completion of anesthetizing the skin, within approximately 1 minute of starting||||units on a scale||Standard Deviation|Mean
2589943|NCT02288364|Primary|Pain|Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.|immediately prior to anesthetizing, within approximately 1 minute of starting||||units on a scale||Standard Deviation|Mean
2589962|NCT02288091|Secondary|Blood Biomarkers (GSH) at Baseline and Week 12|Blood samples will be obtained at baseline and after 12 weeks of treatment to measure biomarkers of oxidative stress and damage such as glutathione (GSH).|12 weeks|Two (2) subjects did not have blood drawn for GSH analysis at the Baseline Visit. Five (5) subjects did not have blood drawn for GSH analysis at the Week 12 visit. These missing samples are due to technical issues, such as a difficult blood draw or issue with sample processing.|||ƥM||Standard Deviation|Mean
2589944|NCT02288325|Primary|Time to First Relapse During the Double-Blind Treatment Period (DBTP)|Time to relapse for the median was measured in days from randomization date at the start of the DBTP to relapse date during DBTP. Relapse was defined as meeting any 1 or more of the following criteria: 1) Insufficient therapeutic response at any one visit, including a >/= 2 increase in Clinical Global Impressions-Severity (CGI-S) score (range 1 to 7) compared with that obtained at randomization, or risk of suicide as determined by the investigator, or need for hospitalization due to worsening of depression as determined by the investigator, or need for alternative treatment of depressive symptoms as determined by the Investigator; 2) Montgomery-Asberg Depression Rating Scale (MADRS) total score >/= 18 (range 0 to 60) at 2 consecutive visits (second visit within 7 to 14 days after the first visit at which the MADRS total score was ≥ 18). Participant was considered censored at the last visit during DBTP if participant did not meet the relapse criteria during DBTP.|From the randomization date (Week 20) to the relapse date during the 26-week DBTP (up to Week 46)|Double-blind Intent-to-Treat (ITT) population comprised of all participants in the Double-blind Safety Population who had at least 1 post-randomization assessment of MADRS or those participants who met relapse criteria during the DBTP of the study.|||days||95% Confidence Interval|Median
2589945|NCT02288312|Secondary|AUC0-∞ (BIA 2-005)|AUC0-∞ (BIA 2-005) - the area under the plasma BIA 2-005 concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/λz), where Clast is the last quantifiable concentration and λz the apparent terminal rate constant; (BIA 2-005 is a BIA 2-093 metabolite)|pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.||||ng.h/mL||Standard Deviation|Mean
2589946|NCT02288312|Secondary|Tmax (BIA 2-005)|tmax (BIA 2-005) - the time of occurrence of Cmax of BIA 2-005 (BIA 2-005 is a BIA 2-093 metabolite)|pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.||||hours||Standard Deviation|Mean
2589947|NCT02288312|Secondary|AUC0-t (BIA 2-005)|AUC0-t (BIA 2-005) - the area under the plasma concentration-time curve from time zero to the last sampling time at which BIA 2-005 concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule (BIA 2-005 is a BIA 2-093 metabolite)|pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.||||ng.h/mL||Standard Deviation|Mean
2589948|NCT02288312|Primary|Cmax (BIA 2-005)|Cmax (BIA 2-005) - maximum observed plasma drug concentration of BIA 2-005 (BIA 2-093 metabolite)|pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.||||ng/mL||Standard Deviation|Mean
2589949|NCT02288273|Secondary|Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10||Week 4 and Week 10||||% times patients had specific CGM/24-hr||Standard Error|Least Squares Mean
2589950|NCT02288273|Secondary|Change in HbA1c From Baseline to Day 22 and Baseline to Day 70||Day 22 and Day 70||||% Alc||Standard Error|Least Squares Mean
2589951|NCT02288273|Secondary|Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10||Week 4 and Week 10||||mg/dL||Standard Error|Least Squares Mean
2589952|NCT02288273|Secondary|Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal)||Day 22 and Day 64||||mg/dL||Standard Error|Least Squares Mean
2589953|NCT02288273|Secondary|Change From Baseline (Day1) to Day 70 and Day 22 in FPG||Day 22/Day70||||mg/dL||Standard Error|Least Squares Mean
2589954|NCT02288273|Secondary|Change in 24-hour Mean Weighted Glucose Between Day 1 of Week 10 (Day 64/65) and Day 6 of Week 10 (Day 69/70) Within Each EQW-treated Patient||Day 64/65||||mg/dL||Standard Error|Least Squares Mean
2589955|NCT02288273|Primary|Change in 24-hour Mean Weighted Glucose|Change in 24-hour mean weighted glucose from baseline (Day -1/1) to Day 6 of Week 4 (Day 27/28) and to Day 6 of Week 10 (Day 69/70).|Day 27/28||||(mg/dL)|(mg/dL)|Standard Deviation|Mean
2589956|NCT02288182|Other Pre-specified|Basic Bone Situation|This measure describes the basic bone situation of the patients at baseline, i.e. the bone thickness as a unit of area before the application of bone substitute material.|6 months +/- 7 days after bone augmentation|ITT Data Set|||mm^2||Standard Deviation|Mean
2589957|NCT02288182|Secondary|Success Rate of Study Implants|"Buser success criteria:~Absence of persisting subjective discomfort such as pain, foreign body perception and or dysaesthesia (painful sensation)~Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics)~Absence of implant mobility on manual palpation~Absence of any continuous peri-implant radiolucency."|4 months +/- 1 month after implant placement|ITT Data Set|||Participants|||Count of Participants
2589958|NCT02288182|Secondary|Survival Rate of Study Implants (Based on Subjects)|Number of implants in place|4 months +/- 1 month after implant placement|ITT Data Set|||Participants|||Count of Participants
2589959|NCT02288182|Primary|Ratio of Newly Formed Bone to Residual Bone Graft in Patients Treated With Straumann® VivOss™ Compared to Geistlich Bio-Oss®|Bone biopsies and histological staining|6 months +/- 7 days after bone augmentation|The biopsies were retrieved from the central part of the dental implant osteotomy. In patients with bilateral treatment, biopsies were taken from both sinuses.|||ratio|biopsies|Inter-Quartile Range|Median
2589960|NCT02288091|Secondary|Blood Biomarkers (FRAP) at Baseline and Week 12|Blood samples will be obtained at baseline and after 12 weeks of treatment to measure biomarkers of oxidative stress and damage such as ferric reducing antioxidant power (FRAP).|12 weeks|One (1) subject did not have blood drawn for FRAP analysis at the Baseline Visit. Four (4) subjects did not have blood drawn for FRAP analysis at the Week 12 visit. These missing samples are due to technical issues, such as a difficult blood draw or issue with sample processing.|||µM||Standard Deviation|Mean
2589961|NCT02288091|Secondary|Neuroimaging Biomarkers at Baseline and Week 12|Magnetic resonance spectroscopy (MRS) will be performed to measure the levels of glutathione in the motor cortex; levels of glutathione at Week 12 (post-treatment) will be compared to pre-treatment levels.|12 weeks|Five (5) subjects did not have a MRS done at the Baseline and Week 12 visits. Of the 20 that had a baseline MRS, 2 patients did not have a Week 12 MRS done. These missing MRS scans are due to technical difficulties, such as subjects were unable to complete the scan.|||mM||Standard Deviation|Mean
2589963|NCT02288091|Primary|Tolerability to Complete the Entire 12 Week Study on Study Drug.|Tolerability will be defined as the ability of subjects to complete the entire 12-week study on study drug.|12 weeks|Twenty-four (24) out of twenty-five (25) participants completed 12 weeks of study drug treatment.|||Participants|||Count of Participants
2589964|NCT02288091|Primary|Number of Participants Experiencing Adverse Events|Safety will be assessed by the occurrence of adverse events.|12 weeks|No expected adverse events of special interest, such as kidney stones and gout, occurred during the course of the study. However, twenty-two (22) out of twenty-five (25) participants did experience an adverse event during the course of the study.|||Participants|||Count of Participants
2589965|NCT02287922|Secondary|Number of Treatment-related Treatment-emergent Adverse Event|treatment related = considered at least possibly related to study drug by the Investigator|From baseline until Week 12|Safety Population|||treatment-emergent adverse events|||Number
2589966|NCT02287922|Secondary|Number and Percentage of Subjects With a Treatment-related Treatment-emergent Adverse Event|treatment related = considered at least possibly related to study drug by the Investigator|From baseline until Week 12|Safety population|||Participants|||Count of Participants
2589967|NCT02287922|Secondary|Number of Treatment-emergent Adverse Event by Severity||From baseline until Week 12|Safety population|||Treatment-emergent adverse events|||Number
2589968|NCT02287922|Secondary|Number and Percentage of Subjects With Treatment-emergent Adverse Event by Severity||From baseline until Week 12|Safety Population|||Participants|||Count of Participants
2589969|NCT02287922|Secondary|Number and Percentage of Subjects With Development of a Treatment-emergent Antidrug Antibody Response||From first study drug intake up to and including follow-up (FU), i.e., maximum of 22 weeks (10 weeks of treatment + 12 weeks of FU)|Safety population|||Participants|||Count of Participants
2589970|NCT02287922|Secondary|Pharmacokinetics: ALX-0061 Concentration in Serum at Week 12||From baseline until Week 12|PK Population, participants with data available|||micrograms/milliliter||Standard Deviation|Geometric Mean
2589971|NCT02287922|Secondary|Pharmacodynamics: Concentrations of Soluble Interleukin-6 Receptor (sIL-6R)|Values below the limit of quantification are imputed with the lower limit of quantification (LLOQ).|From baseline until Week 12|Safety population|||ng/mL||Standard Error|Mean
2589972|NCT02287922|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale at Week 12|The FACIT Measurement System is a collection of health-related quality of life questionnaires that assess multidimensional health status in people with various chronic illnesses. The FACIT Fatigue Scale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). To score the FACIT-fatigue, all items are summed to create a single fatigue score with a range from 0 to 52. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.|From baseline until Week 12|Intent-to-treat population, number of subjects with data available|||score on a scale||Standard Error|Mean
2589973|NCT02287922|Secondary|Change From Baseline in Physical and Mental Component Scores of Short Form Health Survey (SF-36) at Week 12|The Short Form (36) Health Survey (SF-36) consists of 36 items that can be summarized into 8 domains: physical functioning, role limitations due to physical health problems (role-physical), bodily pain, general health, vitality, social functioning, role limitations due to emotional problems (role-emotional), and mental health. Two summary measures, the physical component summary and the mental component summary, can be derived based on these domain scores. Each score is directly transformed into a 0-100 score on the assumption that each question carries equal weight. Low score indicates greater disability.|From baseline until week 12|Intent-to-treat population|||score on a scale||Standard Error|Mean
2589974|NCT02287922|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12|"The HAQ-DI is a 20-question instrument which assesses the degree of difficulty the subject had in accomplishing tasks in 8 functional areas over the previous week. The 8 areas are: dressing and grooming, hygiene, arising, reach, eating, grip, walking, common daily activities. Within each area, subjects report the amount of difficulty they have in performing the specific items. There are 4 response options ranging from: 0 = No Difficulty, 1 = With Some Difficulty, 2 = With Much Difficulty, 3 = Unable to Do. The 8 areas are each given a single score equal to the maximum value of their component activities (0, 1, 2, or 3). The sum of the area scores is then divided by the number of areas answered to obtain the final HAQ score (rounded to the nearest value evenly divisible by 0.125). The final HAQ-DI score ranges from 0 to 3. A high score means a high degree of disability (=worse outcome).~Missing values were imputed with the last non-missing observation."|From baseline until Week 12|Intent-to-treat population, number of participants with data available|||score on a scale||Standard Error|Mean
2589975|NCT02287922|Secondary|Number and Percentage of Subjects in Remission Using Boolean Defined Remission Criteria at Week 12|"Boolean remission: tender joint count (TJC)28 ≤ 1 and swollen joint count (SJC)28 ≤ 1 and VASPA (cm) ≤ 1 and CRP (mg/dL) ≤ 1~This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders."|Week 12||||Participants|||Count of Participants
2589976|NCT02287922|Secondary|Number and Percentage of Subjects in Remission Using CDAI at Week 12|"CDAI = TJC28 + SJC28 + VASPA + VASPHA~Remission: CDAI ≤ 2.8~This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders."|Week 12|Intent-to-treat population|||Participants|||Count of Participants
2589977|NCT02287922|Secondary|Number and Percentage of Subjects in Remission Using SDAI at Week 12|"SDAI = TJC28 + SJC28 + VASPA + VASPHA + CRP (mg/dL)~Remission: SDAI ≤ 3.3~This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders."|Week 12|Intent-to-treat population|||Participants|||Count of Participants
2589978|NCT02287922|Secondary|Number and Percentage of Subjects in Remission Using DAS28 (ESR) at Week 12|"DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln[ESR]) +(0.014 × VASPA)~Remission = DAS28(ESR) < 2.6~This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders."|Week 12||||Participants|||Count of Participants
2589979|NCT02287922|Secondary|Number and Percentage of Subjects With European League Against Rheumatism (EULAR) (CRP) Good Response at Week 12|"EULAR good response is defined as an improvement of >1.2 in DAS28 (CRP) relative to baseline.~This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders."|Week 12|Intent-to-treat population|||Participants|||Count of Participants
2603255|NCT02134119|Secondary|Hematological Measures - Ferritin|as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)||||ng/mL||Standard Deviation|Mean
2589980|NCT02287922|Secondary|Number and Percentage of Subjects With LDA Using Clinical Disease Activity Index (CDAI) at Week 12|"CDAI = TJC28 + SJC28 + VASPA + VASPHA~Low disease activity: 2.8 < CDAI ≤ 10~Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders."|Week 12|Intent-to-treat population|||Participants|||Count of Participants
2589981|NCT02287922|Secondary|Number and Percentage of Subjects With LDA Using Simplified Disease Activity Index (SDAI) at Week 12|"SDAI = TJC28 + SJC28 + VASPA + VASPHA + CRP (mg/dL)~Low disease activity: 3.3 < SDAI ≤ 11.0~Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using non-responder imputation (NRI), i.e., subjects with missing response at the concerned visit were treated as non-responders."|Week 12|Intent-to-treat population|||Participants|||Count of Participants
2589982|NCT02287922|Secondary|Number and Percentage of Subjects With LDA Using DAS28 Using Erythrocyte Sedimentation Rate (ESR) at Week 12|"DAS28(ESR) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.70 × ln[ESR]) +(0.014 × VASPA)~Low disease activity = 2.6 ≤ DAS28 ≤ 3.2~Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders."|Week 12|Intent-to-treat population|||Participants|||Count of Participants
2589983|NCT02287922|Secondary|Number and Percentage of Subjects With Low Disease Activity (LDA) Using Disease Activity Score Using 28 Joint Counts (DAS28) Using C-reactive Protein (CRP) at Week 12|"DAS28(CRP) = (0.56 × √TJC28) + (0.28 × √SJC28) + (0.36 × ln[CRP+1]) + (0.014 × VASPA) + 0.96~Low disease activity = 2.6 ≤ DAS28 ≤ 3.2~Subjects with low disease activity includes subjects who are in remission. This endpoint was analyzed using NRI, i.e., subjects with missing response at the concerned visit were treated as non-responders."|Week 12|Intent-to-treat population|||Participants|||Count of Participants
2589984|NCT02287922|Secondary|Number and Percentage of Subjects With ACR50 and ACR70 Response at Week 12|"ACR50/70 response is defined as:~50/70% improvement in TJC (68 joints) relative to Week 0 AND~50/70% improvement in SJC (66 joints) relative to Week 0 AND~50/70% improvement in 3 of the following 5 areas relative to Week 0:~Subject's Assessment of Pain (100 mm - VAS)~Subject's Global Assessment of Disease Activity (VASPA)~Physician's Global Assessment of Disease Activity (VASPHA)~Subject's assessment of physical function as measured by HAQ-DI~CRP level~This endpoint was analyzed using NRI, i.e., subjects with missing response at Week 12 were treated as non-responders."|Week 12|Intent-to-treat population|||Participants|||Count of Participants
2589985|NCT02287922|Primary|Number and Percentage of Subjects With American College of Rheumatology 20 (ACR20) at Week 12|"ACR 20 response is defined as:~20% improvement in tender joint count (TJC; 68 joints) relative to Week 0 AND~20% improvement in swollen joint count (SJC; 66 joints) relative to Week 0 AND~20% improvement in 3 of the following 5 areas relative to Week 0:~Subject's Assessment of Pain (100 mm - visual analogue scale [VAS])~Subject's Global Assessment of Disease Activity (VASPA)~Physician's Global Assessment of Disease Activity (VASPHA)~Subject's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI)~C-reactive protein (CRP) level~The primary endpoint was analyzed using non-responder imputation (NRI), i.e., subjects with missing ACR20 response at Week 12 were treated as non-responders."|Week 12|Intent-to-treat population|||Participants|||Count of Participants
2589986|NCT02287896|Primary|AUC 0-t|"AUC 0-t (area under the concentration-time curve from time 0 to time Tlast) of Roledumab in all ITT subjects enrolled in the IM arm or the IV arm, who had at least one valid PK assessment after the first IMP administration, providing at least one evaluable PK parameter.~Only samples post-first administration (antenatal samples) will be analyzed by NCA PK analysis for each study arm."|for IM: T0, 48h, 120h, 9 days, 29 days, 59 days and for IV T0, 1h, 24h, 48h, 96-120h, 29 days, 59 days|In the IV arm, the number of participants analyzed was 25. Due to a sensitizing event at late stage of pregnancy in one woman and a premature delivery in another woman, the number of subjects in the analyzed population was 23.|||h*ng/mL||Full Range|Median
2589987|NCT02287896|Primary|T 1/2|"T 1/2 (apparent plasma terminal elimination half-life) of Roledumab in all ITT subjects enrolled in the IM arm or the IV arm, who had at least one valid PK assessment after the first IMP administration, providing at least one evaluable PK parameter.~Only samples post-first administration (antenatal samples) will be analyzed by NCA PK analysis for each study arm."|for IM:T0, 48h, 120h, 9 days, 29 days, 59 days and for IV: T0, 1h, 24h, 48h, 96-120h, 29 days, 59 days|"In the IM arm, the number of participants analyzed was 34, but only 28 subjects with AUCextrap <30% were eligible.~In the IV arm, the number of participants analyzed was 25. Due to a sensitizing event at late stage of pregnancy in one woman and a premature delivery in another woman, the number of subjects in the analyzed population was 23."|||hour||Full Range|Median
2589988|NCT02287896|Primary|T Max|"T max (time of the maximum observed plasma concentration) of Roledumab in all ITT subjects enrolled in the IM arm or the IV arm, who had at least one valid PK assessment after the first IMP administration, providing at least one evaluable PK parameter.~Only samples post-first administration (antenatal samples) will be analyzed by NCA PK analysis for each study arm."|for IM:T0, 48h, 120h, 9 days, 29 days, 59 days and for IV T0, 1h, 24h, 48h, 96-120h, 29 days, 59 days|In the IV arm (PKS3), the overall number of participants analyzed was 25. Due to a sensitizing event at late stage of pregnancy in one woman and a premature delivery in another woman, the number of subjects in the analyzed population was 23.|||hour||Full Range|Median
2589989|NCT02287896|Primary|C Max|"C max (maximum observed serum concentration) of Roledumab in all ITT subjects enrolled in the IM arm or the IV arm, who had at least one valid PK assessment after the first IMP administration, providing at least one evaluable PK parameter.~Only samples post-first administration (antenatal samples) will be analyzed by NCA PK analysis for each study arm."|for IM:T0, 48h, 120h, 9 days, 29 days, 59 days and for IV T0, 1h, 24h, 48h, 96-120h, 29 days, 59 days|In the IV arm (PKS3), the overall number of participants analyzed was 25. Due to a sensitizing event at late stage of pregnancy in one woman and a premature delivery in another woman, the number of subjects in the analyzed population was 23.|||ng/mL||Full Range|Median
2589990|NCT02287896|Primary|t 1/2 : Terminal Half-life|"The parameter was estimated through a population pharmacokinetic model, during which concentration data (ante- and postnatal) obtained after single IM or IV route dose of roledumab.~All samples (ante- and postnatal samples for IM and IV route) will be used for population PK modeling."|IM: Antenatal PK time points at T0, 48h, 120h, 9d, 29d,59d and Posnatal PK time points at TO, 3d,9d, 6 weeks IV: antenal PK time points at T0, 1h, 24h, 48h, 96-120h, 29d, 59d and Postnatal PK time points at T0, 3d, 9d, 6 weeks.||||hour||Standard Error|Mean
2589991|NCT02287896|Primary|V2/F : Central Volume of Distribution|"The parameter was estimated through a population pharmacokinetic model, during which concentration data (ante- and postnatal) obtained after single IM or IV route dose of roledumab.~All samples (ante- and postnatal samples for IM and IV route) will be used for population PK modeling."|IM: Antenatal PK time points at T0, 48h, 120h, 9d, 29d,59d and Posnatal PK time points at TO, 3d,9d, 6 weeks IV: antenal PK time points at T0, 1h, 24h, 48h, 96-120h, 29d, 59d and Postnatal PK time points at T0, 3d, 9d, 6 weeks.||||L||Standard Error|Mean
2589992|NCT02287896|Primary|CL/F : Apparent Clearance|"The parameter was estimated through a population pharmacokinetic model, during which concentration data (ante- and postnatal) obtained after single IM or IV route dose of roledumab.~All samples (ante- and postnatal samples for IM and IV route) will be used for population PK modeling."|IM: Antenatal PK time points at T0, 48h, 120h, 9d, 29d,59d and Posnatal PK time points at TO, 3d,9d, 6 weeks IV: antenal PK time points at T0, 1h, 24h, 48h, 96-120h, 29d, 59d and Postnatal PK time points at T0, 3d, 9d, 6 weeks.||||L/h||Standard Error|Mean
2589993|NCT02287883|Primary|PHQ-4|Patient Reported Emotional Functioning, scale 1 (anxious or depressed nearly every day) -5 (not at all anxious or depressed). Outcome measure is the mean of the change in scores reported by each patient between baseline (2015) and at one-year follow-up (2016).|1 year|Patients who completed a survey at both baseline and at one-year follow-up.|||units on a scale||Standard Deviation|Mean
2589994|NCT02287883|Primary|PROMIS Short Form 12a|Patient-Reported Physical Functioning, scale 1 (unable to do activity) -5 (no difficulty). Outcome measure is the mean of the change in scores reported by each patient between baseline (2015) and at one-year follow-up (2016).|1 year|Patients completing a survey at both baseline (2015) and one-year follow-up (2016).|||units on a scale||Standard Deviation|Mean
2589995|NCT02287883|Primary|PROMIS Short Form 8a|Patient Reported Social Functioning, scale 1 (always trouble or limited)-5 (never trouble or limited). Outcome measure is the mean of the change in scores reported by each patient between baseline (2015) and at one-year follow-up (2016).|1 year|Patients who completed surveys at both baseline (2015) and at one year follow-up (2016).|||units on a scale||Standard Deviation|Mean
2589996|NCT02287779|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) of Volixibat (SHP626)||Day 1 to Day 14|Pharmacokinetic set. Due to minimal absorption of volixibat no participant had sufficient and interpretable primary pharmacokinetic data.||||||
2589997|NCT02287779|Secondary|Maximum Observed Plasma Concentration (Cmax) of Volixibat||Day 1 to Day 14|Pharmacokinetic set consisted of all participants in the safety analysis set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Due to minimal absorption of volixibat no participant had sufficient and interpretable primary pharmacokinetic data.||||||
2589998|NCT02287779|Secondary|Number of Participants With Stool Hardness Using Bristol Stool Chart|Stool hardness was assessed after each evacuation using the bristol stool chart, a medical aid designed to classify the form of human feces into 7 categories where type 1 is the hardest and type 7 is the softest.|Day -2 to Day 14|Pharmacodynamic set.|||participants|||Number
2589999|NCT02287779|Secondary|Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration|Serum 7- alpha-hydroxy-4-cholesten-3-one (C4) concentrations were reported.|Day -1 to Day 15|Pharmacodynamic set.|||nanogram per milliliter||Standard Deviation|Mean
2590000|NCT02287779|Secondary|Average Total Fecal Bile Acid (FBA) Concentration|Stool samples for the determination of total FBA were collected in 48-hour windows from 48 hours before dosing on Day 1 through Day 14. The average of daily total FBA excretion is calculated before (Day -1 and Day -2) as the first pre dose of IMP and after (Day 1-12) as the first post-dose of IMP. The FBA is calculated as Total FBA (micromoles) = FBA (micromol per liter) * weight (grams) divided by 10^3. Participants with fecal bile acid concentration and their average pre-first dose and average post-first dose were reported.|Day -2 up to Day 14|Pharmacodynamic set consisted of all participant in the safety analysis set for whom the primary pharmacodynamic data were considered sufficient and interpretable.|||nanomoles*gram per liter||Standard Deviation|Mean
2590001|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Who Discontinued From the Study|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.|||participants|||Number
2590002|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs)|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.|||participants|||Number
2590003|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead)|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Twelve lead electrocardiogram parameters [(heart rate (HR), PR, RR, QRS and QT intervals and information on T-wave morphology (normal/abnormal) and U-wave morphology (absent/normal or abnormal)] were assessed.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.|||participants|||Number
2590004|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Vital signs parameter included evaluation of orthostatic blood pressure, respiratory rate and body temperature.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.|||participants|||Number
2590005|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Urinalysis parameters included evaluation of pH, glucose, protein, nitrites, leukocyte esterase, occult blood, ketones, bilirubin and specific gravity levels.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.|||participants|||Number
2590006|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Standard chemistry parameters included evaluation of sodium, potassium, glucose, blood urea nitrogen, creatinine, calcium, chloride, thyrotropin, thyroxine, tri-iodothyronine, phosphorus, protein, bicarbonate or carbon dioxide, albumin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, alkaline phosphatase, total bilirubin, urate, beta-human chorionic gonadotropin and follicle-stimulating hormone levels. Participant with TEAE related to standard chemistry were reported with hepatic enzyme increase.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set|||participants|||Number
2590007|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Coagulation included international normalized ratio, activated partial thromboplastin time and prothrombin time.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.|||participants|||Number
2590008|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Thyroid hormone panel parameters included evaluation of thyroid hormones (TSH [thyroid stimulating hormone]; T3 [triiodothyronine] and T4 [thyroxine]).|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.|||participants|||Number
2590009|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Lipid panel parameters included evaluation of total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol and low-density lipoprotein (LDL) cholesterol.|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.|||participants|||Number
2590010|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E)|TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Fat soluble vitamin included vitamin A (serum retinol), vitamin D (serum 25-hydroxycholecalciferol) and vitamin E (serum alfa-tocopherol).|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set.|||participants|||Number
2590011|NCT02287779|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology|TEAEs were defined as events that either had a start date on or after the first dose of investigational medicinal product (IMP) or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An adverse event (AE) that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Hematology parameters included evaluation of hemoglobin, hematocrit, red blood cells, platelets, white blood cell count; total and differential, neutrophils (absolute), eosinophils (absolute), monocytes (absolute), basophils (absolute) and lymphocytes (absolute).|From the start of the study drug administration up to 9 days after the last dose of study drug administration|Safety analysis set included all participants for whom a randomization number was assigned and who had taken >= 1 dose of IMP.|||participants|||Number
2590012|NCT02287688|Primary|Incidence Rate of Medical Diagnoses Following Any Dose of MenACWY- CRM Vaccination|The incidence rate of diagnoses was defined as the number of all captured diagnoses divided by the total person-time following MenACWY-CRM doses administered during the study period. The rate and Poisson 95% CI of medical diagnoses were calculated and presented as number per person-year.Person-time for each dose began at the date of the vaccination and ended at 6 months following vaccination, disenrollment, death, the end of data collection, or receipt of an additional dose of MenACWY-CRM, whichever came first. Diagnoses were classified according ICD-9 codification. All medical diagnoses assessed are presented in short forms with the ICD code, due to character limitations.|Within 6 months after any dose of MenACWY-CRM|Analysis was performed on medical events collected from children, who received at least one dose of the study vaccine at a Kaiser Permanente Southern California (KPSC) facility.|||Events per person-year||95% Confidence Interval|Number
2590025|NCT02287636|Secondary|Radiation Dose Reduction Associated With PET/MRI|Tabulations of summary statistics, graphical presentations, and statistical analyses will be performed. Statistical tests will use a 0.10 significance level and will be 2-sided unless otherwise noted. Confidence intervals, both individual and simultaneous, will be at 90% confidence level unless stated otherwise.|1 day|Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible.||||||
2590013|NCT02287688|Primary|Number of Medical Diagnoses Following Any Dose of MenACWY-CRM Vaccination|All medical diagnoses that required ED or hospitalization visits within 6 months of vaccination were assessed. Events with a history of the same diagnosis prior to the first dose of MenACWY-CRM vaccination were excluded as pre-existing conditions. Data presented for this outcome measure includes all medical diagnoses after the first and recurrent diagnoses. Diagnoses were identified from Electronic Medical Records (EMRs) of emergency and hospital care encounters by automated algorithm identification and then were manually reviewed by a physician to determine the final diagnosis/ diagnoses and diagnosis dates for the encounter. Diagnoses were classified according to International Classification of Diseases, ninth revision (ICD-9) codification. All medical diagnoses assessed are presented in short forms with the ICD code, due to character limitations.|Within 6 months after any dose of MenACWY-CRM|Analysis was performed on children, who received at least one dose of the study vaccine at a Kaiser Permanente Southern California (KPSC) facility.|||Medical diagnoses|||Number
2590014|NCT02287688|Primary|Number of Subjects Who Experienced Single or Mutiple Medical Diagnoses|Number of subjects who experienced single or multiple medical diagnoses after the MenACWY-CRM dose were reported|Within 6 months after any dose of MenACWY-CRM|Analysis was performed on children, who received at least one dose of the study vaccine at a Kaiser Permanente Southern California (KPSC) facility.|||Participants|||Count of Participants
2590015|NCT02287688|Primary|Incidence Rate of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination|The incidence rate of medical encounters was defined as the number of all captured encounters divided by the total person-time following MenACWY-CRM doses administered during the study period. The rate and Poisson 95% CI of medical encounters were calculated and presented as number per person-year. Person-time for each dose began at the date of the vaccination and ended at 6 months following vaccination, disenrollment, death, the end of data collection, or receipt of an additional dose of MenACWY-CRM, whichever came first.|Within 6 months after any dose of MenACWY-CRM|Analysis was performed on children, who received at least one dose of the study vaccine at a Kaiser Permanente Southern California (KPSC) facility.|||Events per person-year||95% Confidence Interval|Number
2590016|NCT02287688|Primary|Number of Medical Encounters Following Any Dose of MenACWY-CRM Vaccination|All medical encounters that required ED visits and hospitalizations within 6 months of vaccination were assessed. Medical encounters were considered pre-existing if all diagnoses made during an ED and/or hospitalization were pre-existing. If a study subject was first seen in the ED and subsequently transferred to the hospital, this was treated as a single episode of care.|Within 6 months after any dose of MenACWY-CRM|Analysis was performed on children, who received at least one dose of the study vaccine at a Kaiser Permanente Southern California (KPSC) facility.|||Medical encounters|||Number
2590017|NCT02287688|Primary|Number of Subjects Who Experienced Single or Multiple Medical Encounters|The number of subjects who experienced single or multiple encounters of medical events resulting in Emergency Department (ED) or hospitalization visits were reported|Within 6 months after any dose of MenACWY-CRM vaccination|Analysis was performed on children, who received at least one dose of the study vaccine at a Kaiser Permanente Southern California (KPSC) facility.|||Participants|||Count of Participants
2590018|NCT02287675|Secondary|Pathologic Assessment of the Excised Lymph Node(s)|To compare pathologic assessment of the excised lymph node(s) to confirm the presence/absence of tumor metastases for Lymphoseek vs 99mTc-SC.|24 hours|Intraoperative Lymph Nodes extracted with presence of radiotracer|||Lymph Nodes|Lymph Nodes||Count of Units
2590019|NCT02287675|Secondary|Patient Pain Tolerance|To compare patient pain tolerance (i.e., patient's perceived level of discomfort) at the injection site for Lymphoseek vs 99mTc-SC using Wong-Baker pain rating scale of 0-10, where the higher the score, the higher the pain level.|24 hours||||score on a scale||Standard Deviation|Mean
2590020|NCT02287675|Secondary|Ratio of Intraoperative Gamma Counts|To compare differences in the ratio of intraoperative counts for Lymphoseek vs 99mTc-SC for the hottest harvested axillary Sentinel Lymph Node (SLN) relative to the primary intradermal injection site.|24 hours||||Ratio||Standard Deviation|Mean
2590021|NCT02287675|Secondary|Number of Intraoperatively Detected Sentinel Lymph Nodes (SLNs) Identified|To compare the number of intraoperatively detected SLNs identified by Lymphoseek and 99mTc-SC on an agent cohort basis|24 hours|Lymph Nodes Removed Intraoperative|||Lymph Nodes|Lymph Nodes||Number
2590022|NCT02287675|Primary|Sentinel Lymph Node Uptake Rate|SLN uptake rates will be determined by planar SPECT (single-photon emission computerized tomography) imaging and by SPECT/CT (CT-computed tomography). Gamma counts will be obtained at the injection site by standard sequential planar imaging at 30 to 60 seconds intervals until the sentinel lymph node is seen. Once a sentinel node is located, a SPECT/CT will be performed for higher resolution imaging in transaxial, coronal, and sagittal planes. Figures showing the percent of peak activity in the node versus time will be constructed for each radiopharmaceutical. The average uptake rate for each radiopharmaceutical will be computed and the following test will be conducted using a two-sample t-test at a two-sided α=0.05 (one-sided α=0.025) level of significance: H0 (null hypothesis): µLS ≤ µSC vs. HA (alternative hypothesis): µLS > µSC, (µLS is the average SLN uptake rate of Lymphoseek) (µSC is the average SLN uptake rate of 99mTc Sulfur Colloid).|2 hours||||minutes||Standard Deviation|Mean
2590023|NCT02287675|Primary|Injection Site Clearance for Lymphoseek and 99mTc-Sulfur Colloid (SC).|The rate of injection site clearance is the time from radiotracer injection to peak SLN radioactive level. Injection clearance rates will be determined by planar SPECT imaging and by SPECT/CT. Subjects will undergo standard sequential planar imaging at 30 to 60 seconds intervals until the sentinel lymph node is seen. Once a sentinel node is located, a SPECT/CT will be performed for higher resolution imaging in transaxial, coronal, and sagittal planes.|2 hours||||minutes||Standard Deviation|Mean
2590024|NCT02287636|Secondary|Time Effort Associated With the PET/MRI|Tabulations of summary statistics, graphical presentations, and statistical analyses will be performed. Statistical tests will use a 0.10 significance level and will be 2-sided unless otherwise noted. Confidence intervals, both individual and simultaneous, will be at 90% confidence level unless stated otherwise.|1 day|Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible.||||||
2590026|NCT02287636|Secondary|SUVs Using PET/CT|The means and standard deviations of SUVs will be obtained and compared between PET/MRI and PET/CT using a two-sided two-sample t-test.|1 day|Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible.||||||
2590028|NCT02287636|Primary|Diagnostic Accuracy of PET/CT|Evaluation of the PET/CT imaging platform will be based on the ability to detect lesions. Evaluation of each lesion will be recorded using the following 5 point rating scale: 1=benign, 2=probably benign, 3=indeterminate, 4=probably malignant, 5=malignant. A Wilcoxon (Mann-Whitney) rank-sum test and two-sided z-test will be used to compare diagnostic accuracy of PET/CT with PET/MRI.|1 day|Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible.||||||
2590029|NCT02287636|Primary|Diagnostic Accuracy of PET/MRI|Evaluation of the PET/MR imaging platform will be based on the ability to detect lesions. Evaluation of each lesion will be recorded using the following 5 point rating scale: 1=benign, 2=probably benign, 3=indeterminate, 4=probably malignant, 5=malignant. A Wilcoxon (Mann-Whitney) rank-sum test and two-sided z-test will be used to compare diagnostic accuracy of PET/MRI with PET/CT.|1 day|Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible.||||||
2590030|NCT02287623|Secondary|Post Operative Opioid Use|Post operative opioid use from 0-24 hours after surgery.|0-24 hours||||micrograms of fentanyl equivalents||Inter-Quartile Range|Median
2590031|NCT02287623|Secondary|Postoperative Opioid Use|Use of opioids during 24-48 hours after surgery|24-48 hours||||Micrograms of fentanyl equivalents||Inter-Quartile Range|Median
2590032|NCT02287623|Secondary|Post Operative Length of Stay||up to 30 days after surgery||||HOURS||Inter-Quartile Range|Median
2590033|NCT02287623|Secondary|Number of Patients With Post Operative Nausea/Vomiting||0-72 hours||||participants|||Number
2590034|NCT02287623|Secondary|Post Operative Opioid Use||48-72 hours||||micrograms of fentanyl equivalents||Inter-Quartile Range|Median
2590035|NCT02287623|Primary|Numerical Rating Scale|This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.|48-72 hours after injection||||scores on a scale||Inter-Quartile Range|Median
2590036|NCT02287610|Other Pre-specified|Correlation Between Vectra DA and DAS28 at Each Assessed Time Point|Vectra DA and DAS28 data were collected, however not analyzed or correlated.|Baseline to Last Follow up visit (up to 18.7 weeks)|Analysis and correlations were not completed for this outcome measure.||||||
2590037|NCT02287610|Secondary|Assessment of Unsolicited Serious Adverse Events|Please refer to the safety section for further details.|Baseline to Last Follow up visit (up to 18.7 weeks)||||Participants|||Count of Participants
2590038|NCT02287610|Secondary|Assessment of Unsolicited Adverse Events|Please refer to the safety section for further details.|Baseline to Last Follow up visit (up to 18.7 weeks)||||Participants|||Count of Participants
2590039|NCT02287610|Secondary|Corticosteroid Sparing Effect - Change in Total Daily Prednisone Dose From Baseline to Final Visit (Final Follow-up Visit)|The change in total daily prednisone from baseline to follow-up (whether the patient was taking RAYOS or returned to conventional prednisone) was calculated for all participants.|Baseline to Last Follow up visit (up to 18.7 weeks)||||milligrams||Standard Deviation|Mean
2590040|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Recent Medical History Component From Baseline to Final Visit (Final Follow-up Visit)|"Multidimensional Health Assessment Questionnaire (MDHAQ) - recent medical history was gathered using a medical history checklist and was calculated by summing the total number of items checked Yes (0 to 12 items could be checked). A negative change from baseline indicates fewer items were checked at the follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ recent medical history was only calculated for participants that had measurements at both baseline and final follow-up."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – recent medical history was calculated for participants who had both baseline and follow-up recent medical history data. For this measure, the mean change from baseline is based on 33 participants.|||number of items checked||Standard Deviation|Mean
2590041|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Fatigue (FAT) Component From Baseline to Final Visit (Final Follow-up Visit)|"Multidimensional Health Assessment Questionnaire (MDHAQ) - fatigue (FAT) scoring was gathered using a 0-10 scale where 0 corresponded to Fatigue is no problem and 10 to Fatigue is a major problem over the past week. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in fatigue was only calculated for participants that had measurements at both baseline and final follow-up."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – fatigue (FAT) was calculated for participants who had both baseline and follow-up FAT data. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
2590042|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Exercise (EX) Component From Baseline to Final Visit (Final Follow-up Visit)|"The exercise aerobically for at least one-half hour (30 minutes) measure of the multidimensional health assessment questionnaire (MDHAQ) was scored as follows: 3 or more times a week (3), 1-2 times per week (2), 1-2 times per month (1), Do not exercise regularly (0), Cannot exercise due to disability/handicap (-1). As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ exercise measure was only calculated for participants that had measurements at both baseline and final follow-up."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – exercise (EX) was calculated for participants who had both baseline and follow-up EX data. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
2590068|NCT02287467|Secondary|pH1N1 Titers at Day 7|pH1N1 hemagglutination inhibition assay (HAI) titers among participants infected with pH1N1 using A/Cal/2009 as reference virus|Day 7|participants infected with pH1N1 with HAI titers measured at day 7|||titer||Standard Deviation|Mean
2590069|NCT02287467|Secondary|Number of Influenza B-Infected Patients in Each of 6 Clinical Status Categories on Day 7|Primary 6-category ordinal outcome for subgroup of participants infected with influenza B|Day 7||||Participants|||Count of Participants
2590043|NCT02287610|Secondary|"Change in Multidimensional Health Assessment Questionnaire (MDHAQ) How do You Feel Today (Compared to One Week Ago) Component From Baseline to Final Visit (Final Follow-up Visit)"|"The Multidimensional Health Assessment Questionnaire (MDHAQ) - how do you feel today compared to one week ago question was scored as follows: 1: Much Better, 2: Better, 3: The Same, 4: Worse, 5: Much Worse. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in How do you feel measure was only calculated for participants that had measurements at both baseline and final follow-up."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire - How do you feel today (compared to 1wk ago) from Baseline to Final Visit was calculated for participants who had both baseline and follow-up data. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Error|Mean
2590044|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Morning Stiffness Component From Baseline to Final Visit (Final Follow-up Visit)|The duration of morning stiffness was the amount of time participants experienced stiffness after waking up in the morning (over the last week). This measure was collected at baseline and at the last follow-up visit. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in duration of morning stiffness was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – morning stiffness, minutes (past week) was calculated for participants who had both baseline and follow-up data. For this measure, the mean change from baseline is based on 30 participants.|||minutes||Standard Deviation|Mean
2590045|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Review of Symptoms (ROS) Component From Baseline to Final Visit (Final Follow-up Visit)|Multidimensional Health Assessment Questionnaire (MDHAQ) - review of symptoms (ROS) was gathered using a symptom checklist and was calculated by summing the total number of items checked (0 to 60 symptoms could be checked). A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in MDHAQ ROS was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – review of symptoms (ROS) was calculated for participants who had both baseline and follow-up ROS data. For this measure, the mean change from baseline is based on 33 participants.|||number of symptoms||Standard Deviation|Mean
2590046|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Patient Global Assessment (PTGL) Component From Baseline to Final Visit (Final Follow-up Visit)|Multidimensional Health Assessment Questionnaire (MDHAQ) - patient global assessment (PTGL) was measured by asking the participant to rate on a 0 to 10 scale how they were doing considering all of the ways in which their illness and health conditions affected them: 0 - Very Well, 10 - Very Poor. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in PTGL was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – patient global assessment (PTGL) was calculated for participants who had both baseline and follow-up PTGL data. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
2590047|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Neck and Back (NB) Component From Baseline to Final Visit (Final Follow-up Visit)|"For the Multidimensional Health Assessment Questionnaire (MDHAQ) - neck and back (NB), participants were asked to score the amount of pain they were experiencing in their neck and back as None (score of 0), Mild (score of 1), Moderate (score of 2) or Severe (score of 3). The raw 0-6 score was adjusted to 0-10. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in NB measure was only calculated for participants that had measurements at both baseline and final follow-up."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – neck and back (NB) was calculated for participants who had both baseline and follow-up NB data. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
2590048|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) the Rheumatoid Arthritis Disease Activity Index (RADAI) Patient Self-report Joint Count (PTJT) Component From Baseline to Final Visit (Final Follow-up Visit)|"For the Change in Multidimensional Health Assessment Questionnaire (MDHAQ) - the Rheumatoid Arthritis disease Activity Index (RADAI) patient self-report joint count (PTJT), participants were asked to score the amount of pain they were experiencing in each of 16 joints (left joint, left wrist, right shoulder etc.) as None (score of 0), Mild (score of 1), Moderate (score of 2) or Severe (score of 3). The raw 0-48 score is adjusted to 0-10 using a scoring template. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in PTJT was only calculated for participants that had measurements at both baseline and final follow-up."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – RADAI patient self-report joint count (PTJT) was calculated for participants who had both baseline and follow-up data. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
2590070|NCT02287467|Secondary|Number of Influenza A-Infected Patients in Each of 6 Clinical Status Categories on Day 7|Primary 6-category ordinal outcome for participants infected with Influenza A|Day 7|all participants infected with influenza A|||Participants|||Count of Participants
2590071|NCT02287467|Secondary|Number of Patients in Each of 6 Clinical Status Categories on Day 28|6-category ordinal outcome corresponding to clinical status on day 28|day 28|participants with observed data|||Participants|||Count of Participants
2590049|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Pain (PN) Component From Baseline to Final Visit (Final Follow-up Visit)|"Multidimensional Health Assessment Questionnaire (MDHAQ) - pain (PN) scoring was gathered using a 0-10 scale where 0 corresponded to No Pain and 10 to Pain as bad as it could be because of the condition (over the past week). A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in pain was only calculated for participants that had measurements at both baseline and final follow-up."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – Pain (PN) was calculated for participants who had both baseline and follow-up PN data. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
2590050|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Psychological Status (PS) Component From Baseline to Final Visit (Final Follow-up Visit)|"The change in Multidimensional Health Assessment Questionnaire (MDHAQ) - Psychological status (PS) was assessed by asking participants to score how they were sleeping, dealing with anxiety/nervousness, and dealing with depression as without any difficulty (score of 0), with some difficulty (score of 1.1), with much difficulty (score of 2.2) or unable to do (score of 3.3). The results were summed to give a score ranging from 0 to 9.9. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in psychological status was only calculated for participants that had measurements at both baseline and final follow-up."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – Psychological status (PS) was calculated for participants who had both baseline and follow-up PS data. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
2590051|NCT02287610|Secondary|Change in Multidimensional Health Assessment Questionnaire (MDHAQ) Function (FN) Component From Baseline to Final Visit (Final Follow-up Visit)|"The change in Multidimensional Health Assessment Questionnaire (MDHAQ) - function (FN) was assessed by asking participants to score the performance of multiple activities as without any difficulty (score of 0), with some difficulty (score of 1), with much difficulty (score of 2) or unable to do (score of 3). The results were summed and divided by 3 to give a score from 0 to10. A negative change from baseline indicates improvement. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in function was only calculated for participants that had measurements at both baseline and final follow-up."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Multidimensional Health Assessment Questionnaire (MDHAQ) – Function (FN) was calculated for participants who had both baseline and follow-up FN data. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
2590052|NCT02287610|Secondary|Change in Routine Assessment of Patient Index Data (RAPID3) From Baseline to Final Visit (Final Follow-up Visit)|"Routine Assessment of Patient Index Data (RAPID3) was calculated by summing three measures: physical function (0 to 10 with higher scores indicating less function), pain (0 to 10 with higher scores indicating higher pain), and patient global assessment (0 to 10 with higher scores indicating the participant was doing very poorly considering the ways in which the illness was affecting them). As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in RAPID3 was only calculated for participants that had measurements at both baseline and final follow-up.~RAPID3 scores range from 0 to 30 with higher scores meaning worse condition. A negative change from baseline indicates improvement in condition."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Routine Assessment of Patient Index Data (RAPID3) was calculated for participants who had both baseline and follow-up data required to calculate RAPID3. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
2590053|NCT02287610|Secondary|ACR-N From Baseline to Final Visit (Final Follow-up Visit)|ACR-N is the index of improvement in rheumatoid arthritis, and is defined as the lowest of 3 values: percent change in the number of swollen joints (scored 0-28 with higher scores indicating higher disease activity), percent change in the number of tender joints (scored 0-28 with higher scores indicating higher disease activity), and the median of the other 5 measures in the American College of Rheumatology core data set-Patient's global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician's global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein). Positive percent change indicates improvement. Negative percent change indicates worsening.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR-N scores and 5 participants have only baseline data. ACR-N calculations were performed on data from 24 participants.|||percent change||Standard Deviation|Mean
2590054|NCT02287610|Secondary|Percentage of Participants With American College of Rheumatology 70% Improvement (ACR70) Response From Baseline to Final Visit (Final Follow-up Visit)|American College of Rheumatology (ACR) 70 a patient must demonstrate a >= 70% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 70% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein).|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR70 response and 5 participants have only baseline data. The percentages were calculated based on 56 participants.|||percentage of particpants|||Number
2605740|NCT02107014|Primary|Change in GM-CSF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2590055|NCT02287610|Secondary|Percentage of Participants With American College of Rheumatology 50% Improvement (ACR50) Response From Baseline to Final Visit (Final Follow-up Visit)|American College of Rheumatology (ACR) 50, a patient must demonstrate a >= 50% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 50% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein).|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR20 response and 5 participants have only Baseline data. The percentages were calculated based on 56 participants.|||percentage of participants|||Number
2590056|NCT02287610|Secondary|Percentage of Participants With American College of Rheumatology 20% Improvement (ACR20) Response From Baseline to Final Visit (Final Follow-up Visit)|American College of Rheumatology (ACR) 20, a patient must demonstrate a >= 20% improvement in tender and swollen joints (each scored 0-28 with higher scores indicating higher disease activity) as well as a 20% improvement in at least 3 of the following 5 parameters: patient global assessment (PGA, scored on a 1-10 scale with higher scores indicating higher disease activity), physician global assessment (PhGA, scored on a 1-10 scale with higher scores indicating higher disease activity), pain scale (scored on a 1-10 scale with higher scores indicating higher pain), functional questionnaire (scored on a 1-10 scale with higher scores indicating less function), and acute phase reactant (Erythrocyte Sedimentation Rate or C-reactive Protein).|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. There were 27 participants with insufficient information to calculate ACR20 response and 5 participants have only baseline data. The percentages were calculated based on 56 participants.|||percentage of participants|||Number
2590057|NCT02287610|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response From Baseline to Final Visit (Final Follow-up Visit)|"European League Against Rheumatism (EULAR) response is based on change (improvement) in Disease Activity Score in 28 Joints score from baseline to last follow-up visit. DAS28 scores were broken into 3 categories: ≤3.2 at last follow-up (low disease activity), >3.2 and ≤ 5.1 at last follow-up (moderate or high disease activity), and DAS28 >5.1 at last follow-up (high disease activity). Then based on the category and magnitude of the change in DAS28 from baseline, the EULAR response of Good, Moderate or No Response was determined.~DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined as erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity)."|Baseline to Last Follow up visit (up to 18.7 weeks)||||percentage of participants|||Number
2590058|NCT02287610|Secondary|Change in Simple Disease Activity Index (SDAI) From Baseline to Final Visit (Final Follow-up Visit)|Simple Disease Activity Index (SDAI) is the sum of the following 5 components to assess rheumatoid arthritis severity: Swollen Joint Count 28 (SJC28, scored 0-28 with higher scores indicating higher disease activity) + Tender Joint Count 28 (TJC28, scored 0-28 with higher scores indicating higher disease activity) + Patient Global Assessment (PGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + Physician Global Assessment (PhGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + C-reactive Protein (CRP). SDAI scores indicate whether a participant is in remission or low, moderate or high activity. A negative change in SDAI indicates improvement.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Simple Disease Activity Index (SDAI) was calculated for participants who had both baseline and follow-up data required to calculate SDAI. For this measure, the mean change from baseline is based on 25 participants.|||units on a scale||Standard Deviation|Mean
2590059|NCT02287610|Secondary|Change in Clinical Disease Activity Index (CDAI) From Baseline to Final Visit (Final Follow-up Visit)|"Clinical Disease Activity Index (CDAI) is the sum of 4 parameters: Swollen Joint Count 28 (SJC28, scored 0-28 with higher scores indicating higher disease activity) + Tender Joint Count 28 (TJC28, scored 0-28 with higher scores indicating higher disease activity) + Patient Global Assessment (PGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity) + Physician Global Assessment (PhGA, scored on a visual analogue scale from 1-10 cm with higher scores indicating higher disease activity). CDAI scores range from 0 to 76 and indicate whether a participant is in remission or low, moderate or high activity; higher scores indicate higher disease activity. A negative change from baseline indicates improvement in condition.~As this study was a non-interventional research initiative and no assessments/visits were mandated, the change in CDAI was only calculated for participants that had both baseline and final follow-up measurements."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Clinical Disease Activity Index (CDAI) was calculated for participants who had both baseline and follow-up data required to calculate CDAI. For this measure, the mean change from baseline is based on 33 participants.|||units on a scale||Standard Deviation|Mean
2590072|NCT02287467|Secondary|Resumption of Normal Activities by Day 14|Participants reporting resumption of normal daily activities by Day 14|day 14|Participants with observed data|||Participants|||Count of Participants
2590073|NCT02287467|Secondary|Number of Patients Alive and Out of Hospital on Day 14|Number and percentage of participants alive and out of the hospital on Day 14|day 14|all participants|||Participants|||Count of Participants
2590074|NCT02287467|Secondary|Number of Patients in Each of 6 Clinical Status Categories on Day 14|6-category ordinal outcome measured on day 14|Measured on day 14|participants with observed data on day 14|||Participants|||Count of Participants
2590075|NCT02287467|Secondary|Percent of Participants Developing Complications|Number and percent of participants developing respiratory distress syndrome, acute renal failure, sepsis, pneumonia, enteritis, or bronchitis|Measured through Day 28|all participants|||Participants|||Count of Participants
2605741|NCT02107014|Primary|Change in G-CSF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2590060|NCT02287610|Secondary|Change in Disease Activity Score in 28 Joints Calculated With C-reactive Protein (DAS28-CRP) From Baseline to Final Visit (Final Follow-up Visit)|"The DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined by erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity).~DAS28-CRP was calculated according to the following formula: DAS28-CRP equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + [0.36 * the natural logarithm (ln) of (CRP + 1)] + [0.014 * PGA in mm] + 0.96. A negative change from baseline indicated improvement.~As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in DAS28-CRP was only calculated for participants that had measurements at both baseline and final follow-up."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Disease Activity Score in 28 Joints calculated with C-reactive protein (DAS28-CRP) was calculated for participants who had both baseline and follow-up data required to calculate DAS28-CRP. For this measure, the mean change from baseline is based on 25 participants.|||units on a scale||Standard Deviation|Mean
2590061|NCT02287610|Secondary|Change in Disease Activity Score in 28 Joints Calculated With Erythrocyte Sedimentation Rate (DAS28-ESR) From Baseline to Final Visit (Final Follow-up Visit)|"The DAS28 is an index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response determined by erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), and patient global assessment (PGA) on a visual analogue scale (higher scores indicate higher disease activity).~DAS28-ESR was calculated according to the following formula: DAS28-ESR equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + [0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * PGA in mm]. A negative change from baseline indicates improvement.~As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in DAS28-ESR was only calculated for participants that had measurements at both baseline and final follow-up."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in DAS28-ESR was calculated for participants who had both baseline and follow-up data required to calculate DAS28-ESR. For this measure, the mean change from baseline is based on 15 participants.|||units on a scale||Standard Deviation|Mean
2590062|NCT02287610|Secondary|Change in Physician's Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit)|"Physician's Overall Assessment in Disease Activity was measured with a 10-cm visual analogue scale (VAS) where 0 corresponded to Very Well' and 10 to Very Poor. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in Physician's Overall Assessment in Disease Activity was only calculated for participants that had measurements at both baseline and final follow-up."|Baseline to Last Follow-up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Physician’s Overall Assessment in Disease Activity was calculated for participants who had both baseline and follow-up Physician’s Overall Assessment in Disease Activity data. For this measure, the mean change from baseline is based on 37 participants.|||units on a scale||Standard Deviation|Mean
2590063|NCT02287610|Secondary|Change in Patient's Overall Assessment in Disease Activity From Baseline to Final Visit (Final Follow-up Visit)|Patient's Overall Assessment in Disease Activity was measured by asking the participant to rate on a 10-cm visual analogue scale (VAS) how well they were doing considering all of the ways their arthritis affected them: 0 - Very Well, 10 - Very Poor. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in Patient's Overall Assessment in Disease Activity was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Change in Patient’s Overall Assessment in Disease Activity was calculated for participants who had both baseline and follow-up Patient’s Overall Assessment in Disease Activity data. For this measure, the mean change from baseline is based on 36 participants.|||units on a scale||Standard Deviation|Mean
2590064|NCT02287610|Secondary|Change in Duration of Morning Stiffness (Minutes) From Baseline to Final Visit (Final Follow-Up Visit)|The duration of morning stiffness was the amount of time participants experienced stiffness after getting up in the morning. This measure was collected at baseline and at the last follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the change in duration of morning stiffness was only calculated for participants that had measurements at both baseline and final follow-up.|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. The change in duration of morning stiffness (minutes) was calculated for participants who had both baseline and follow-up morning stiffness data. For duration of morning stiffness, the mean change from baseline is based on 41 participants.|||minutes||Standard Deviation|Mean
2590065|NCT02287610|Primary|Mean Change in Severity of Morning Stiffness (Using 100mm VAS) From Baseline (Week 0) to Final Follow-Up Visit|"Mean change in severity of morning stiffness was assessed using a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to Not Severe at All and 100 to Extremely Severe. This measure was collected at baseline and at the last follow-up visit. As this study was a non-interventional research initiative and no assessments or visits were mandated, the mean change was only calculated for participants that had measurements at both baseline and final follow-up."|Baseline to Last Follow up visit (up to 18.7 weeks)|56 participants were in the per protocol follow-up analysis set. Mean change in severity of morning stiffness was calculated for participants who had both baseline and follow-up severity of morning stiffness data. For severity of morning stiffness, the mean change from baseline is based on 38 participants.|||units on a scale||Standard Deviation|Mean
2590066|NCT02287467|Secondary|Influenza B Titers at Day 7|Flu B HAI titers among participants infected with influenza B using B/Phuket/2013 as reference virus|Day 7|participants infected with influenza B with HAI titers measured at day 7|||titer||Standard Deviation|Mean
2590067|NCT02287467|Secondary|H3N2 Titers at Day 7|H3N2 HAI titers among participants infected with H3N2 using A/HongKong/2014 as reference virus|Day 7|participants infected with H3N2 with HAI titers measured at day 7|||titer||Standard Deviation|Mean
2590081|NCT02287467|Secondary|Number of Patients With a Favorable Outcome on Day 7|Sliding dichotomy defined as non-ICU hospitalization or discharge if enrolled from ICU, and discharge if enrolled from the general ward.|Assessed on Day 7||||Participants|||Count of Participants
2590082|NCT02287467|Secondary|Number of Patients in Each of 6 Clinical Status Categories on Day 3|6-category ordinal outcome evaluated on Day 3; clinical status ranges from death (worst) to discharged from hospital with resumption of normal activities (best).|Measured on Day 3|All participants with clinical data available on Day 3|||Participants|||Count of Participants
2590083|NCT02287467|Secondary|Number of Patients in Each of 5 Clinical Status Categories on Day 3|5-category ordinal outcome assessed on day 3; clinical status ranges from death (worst) to discharged from the hospital (best).|Assessed on Day 3|All participants|||Participants|||Count of Participants
2590084|NCT02287467|Primary|Number of Patients in Each of 6 Clinical Status Categories on Day 7|This is the primary outcome, a 6-category ordinal outcome ranging from death (worst) to discharged from hospital with resumption of normal activities (best).|Assessed on Day 7|All infused participants, using multiple imputation to impute outcome for 4 participants with missing data.|||Participants|||Count of Participants
2590085|NCT02287415|Secondary|AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h, the Dosing Interval||PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.||||ng.h/mL||Standard Deviation|Mean
2590086|NCT02287415|Secondary|Tmax - Time of Occurrence of Cmax||PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.||||hours||Full Range|Median
2590087|NCT02287415|Primary|Cmax - Maximum Steady-state Plasma Concentration||PHASE A: first 3 days; PHASE B: Days 1, 2, 4, 6, 7 and 8: pre-dose. PHASE C: Days 1, 3, 5 and 7: pre-dose; Day 8: 24 h post last-warfarin dose.||||ng/mL||Standard Deviation|Mean
2590088|NCT02287402|Secondary|Body Weight at Follow-up|"Summary statistics were calculated at each assessment time point for the HbA1c in patients who proceeded to the follow-up in the Full Analysis Set."|Follow-up at Week 0, 12, 24, 36, and 48|Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.|||kg||Standard Deviation|Mean
2590089|NCT02287402|Secondary|Body Weight|"Summary statistics were calculated at each assessment time point for the body weight in the Full Analysis Set."|Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.|||kg||Standard Deviation|Mean
2590090|NCT02287402|Secondary|HbA1c at Follow-up|"Summary statistics were calculated at each assessment time point for the HbA1c in patients who proceeded to the follow-up in the Full Analysis Set."|Follow-up at Week 0, 12, 24, 36, and 48|Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.|||percent||Standard Deviation|Mean
2590091|NCT02287402|Secondary|Hemoglobin A1c (HbA1c)|"Summary statistics were calculated at each assessment time point for the HbA1c in the Full Analysis Set."|Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period.|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.|||percent||Standard Deviation|Mean
2590092|NCT02287402|Secondary|2-Hour Plasma Glucose During 75 g OGTT at Follow-up|"Summary statistics were calculated at each assessment time point for the 2-hour plasma glucose during 75 g OGTT in participants who proceeded to the follow-up in the Full Analysis Set."|Follow-up at week 0, 12, 24, 36, and 48|Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.|||mg/dL||Standard Deviation|Mean
2590093|NCT02287402|Secondary|2-Hour Plasma Glucose During 75 g Oral Glucose Tolerance Test (OGTT)|"Summary statistics were calculated at each assessment time point for the 2-hour plasma glucose during 75 g OGTT in the Full Analysis Set."|Week 0, 24, 48, 72, 96, 120, and the end of the treatment period|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.|||mg/dL||Standard Deviation|Mean
2590094|NCT02287402|Secondary|Time to Improvement to Normoglycemia in the Treatment Period Measured Values by the Cumulative Incidence Function|"The cumulative progression rate (percentage of participants) was calculated using the cumulative incidence function for the time to improvement to normoglycemia in the treatment period in the Full Analysis Set."|Day 168, 336, 504, and 672|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.|||percentage of participants|||Number
2590095|NCT02287402|Secondary|Time to Improvement to Normoglycemia in the Treatment Period Calculated by the Kaplan-Meier Method|"The cumulative progression rate (percentage of participants) was calculated by the Kaplan-Meier method for the time to improvement to normoglycemia in the treatment period in the Full Analysis Set."|Day 168, 336, 504, and 672|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.|||percentage of participants|||Number
2590096|NCT02287402|Secondary|Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated Using the Cumulative Incidence Function|"The cumulative progression rate (percentage of participants) was calculated using the cumulative incidence function for the time to progression to type 2 diabetes mellitus in the treatment period in the Full Analysis Set."|Day 168, 336, 504, and 672|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.|||percentage of participants|||Number
2590097|NCT02287402|Secondary|Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated by the Kaplan-Meier Method|"The cumulative progression rate (percentage of participants) was calculated by the Kaplan-Meier method for the time to progression to Type 2 Diabetes mellitus in the treatment period in the Full Analysis Set."|Day 168, 336, 504, and 672|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.|||percentage of participants|||Number
2590098|NCT02287402|Primary|Assessment of Diabetic Status in Follow-up (Type 2 Diabetes Mellitus, Normoglycemia, or IGT)|"Frequency tabulations of the assessment of diabetic status in the follow-up (Type 2 Diabetes mellitus, normoglycemia, or IGT) were prepared in patients who proceeded to the follow-up in the Full Analysis Set."|Follow-up at Week 12, 24, 36, and 48|Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.|||participants|||Number
2605742|NCT02107014|Primary|Change in LIF From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2590099|NCT02287402|Primary|Assessment of Diabetic Status in the Treatment Period (Type 2 Diabetes Mellitus, Normoglycemia, or Impaired Glucose Tolerance (IGT)|"Frequency tabulations of the assessment of diabetic status in the treatment period (Type 2 Diabetes mellitus, normoglycemia, or IGT) were prepared in the Full Analysis Set."|Treatment period: Up to 122 weeks. Treatment was to be ended when patients were assessed as Type 2 Diabetes Mellitus or normoglycemic.|Full Analysis Set - All participants who received at least 1 dose of open-label study drug.|||participants|||Number
2590100|NCT02287376|Secondary|Safety Outcome (7 of 7)|• Physical examination findings including abnormal clinically significant findings|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented is a clinically significant change from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||Participants|||Count of Participants
2590101|NCT02287376|Secondary|Safety Outcome (6.24 of 7)|• Changes in clinical laboratory results: Urinalysis - Specific Gravity.|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||Specific Gravity||Standard Deviation|Mean
2590102|NCT02287376|Secondary|Safety Outcome (6.23 of 7)|• Changes in clinical laboratory results: Urinalysis - pH.|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||pH||Standard Deviation|Mean
2590103|NCT02287376|Secondary|Safety Outcome (6.22 of 7)|• Changes in clinical laboratory results: Chemistry - Sodium (mmol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
2590104|NCT02287376|Secondary|Safety Outcome (6.21 of 7)|• Changes in clinical laboratory results: Chemistry - Potassium (mmol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
2590105|NCT02287376|Secondary|Safety Outcome (6.20 of 7)|• Changes in clinical laboratory results: Chemistry - LDH (U/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||U/L||Standard Deviation|Mean
2590106|NCT02287376|Secondary|Safety Outcome (6.19 of 7)|• Changes in clinical laboratory results: Chemistry - Glucose (mmol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
2590107|NCT02287376|Secondary|Safety Outcome (6.18 of 7)|• Changes in clinical laboratory results: Chemistry - Creatinine (umol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||umol/L||Standard Deviation|Mean
2590108|NCT02287376|Secondary|Safety Outcome (6.17 of 7)|• Changes in clinical laboratory results: Chemistry - Chloride (mmol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
2590109|NCT02287376|Secondary|Safety Outcome (6.16 of 7)|• Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
2590110|NCT02287376|Secondary|Safety Outcome (6.15 of 7)|• Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||umol/L||Standard Deviation|Mean
2590111|NCT02287376|Secondary|Safety Outcome (6.14 of 7)|• Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
2590112|NCT02287376|Secondary|Safety Outcome (6.13 of 7)|• Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||U/L||Standard Deviation|Mean
2590113|NCT02287376|Secondary|Safety Outcome (6.12 of 7)|• Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||U/L||Standard Deviation|Mean
2590452|NCT02283827|Primary|Cmax - the Maximum Plasma Concentration|BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate|Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration||||ng/mL||Standard Deviation|Mean
2590114|NCT02287376|Secondary|Safety Outcome (6.11 of 7)|• Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||U/L||Standard Deviation|Mean
2590115|NCT02287376|Secondary|Safety Outcome (6.10 of 7)|• Changes in clinical laboratory results: Chemistry - Albumin (g/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||g/L||Standard Deviation|Mean
2590116|NCT02287376|Secondary|Safety Outcome (6.9 of 7)|• Changes in clinical laboratory results: Hematology - Monocytes (%).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Monocytes||Standard Deviation|Mean
2590117|NCT02287376|Secondary|Safety Outcome (6.8 of 7)|• Changes in clinical laboratory results: Hematology - Lymphocytes (%).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Lymphocytes||Standard Deviation|Mean
2590118|NCT02287376|Secondary|Safety Outcome (6.7 of 7)|• Changes in clinical laboratory results: Hematology - Neutrophils (%).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Neutrophils||Standard Deviation|Mean
2590119|NCT02287376|Secondary|Safety Outcome (6.6 of 7)|• Changes in clinical laboratory results: Hematology - Eosinophils (%).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Eosinophils||Standard Deviation|Mean
2590120|NCT02287376|Secondary|Safety Outcome (6.5 of 7)|• Changes in clinical laboratory results: Hematology - Basophils (%).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Basophils||Standard Deviation|Mean
2590121|NCT02287376|Secondary|Safety Outcome (6.4 of 7)|• Changes in clinical laboratory results: Hematology - White Blood Cells (Cells * 10^9/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||Cells * 10^9/L||Standard Deviation|Mean
2590122|NCT02287376|Secondary|Safety Outcome (6.3 of 7)|• Changes in clinical laboratory results: Hematology - Platelet Count (Cells * 10^9/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||Cells * 10^9/L||Standard Deviation|Mean
2590123|NCT02287376|Secondary|Safety Outcome (6.2 of 7)|• Changes in clinical laboratory results: Hematology - Hemoglobin (g/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||g/L||Standard Deviation|Mean
2590124|NCT02287376|Secondary|Safety Outcome (6.1 of 7)|• Changes in clinical laboratory results: Hematology - Hematocrit (L/L).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||L/L||Standard Deviation|Mean
2590125|NCT02287376|Secondary|Safety Outcome (5.5 of 7)|• Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mm Hg||Standard Deviation|Mean
2590126|NCT02287376|Secondary|Safety Outcome (5.4 of 7)|• Changes in vital sign measurements: Systolic Blood Pressure (mmHg).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mm Hg||Standard Deviation|Mean
2590127|NCT02287376|Secondary|Safety Outcome (5.3 of 7)|• Changes in vital sign measurements: Respiratory Rate (breaths/min).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||breaths/min||Standard Deviation|Mean
2590128|NCT02287376|Secondary|Safety Outcome (5.2 of 7)|• Changes in vital sign measurements: Heart Rate (beats/min).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||beats/min||Standard Deviation|Mean
2590401|NCT02284373|Primary|To Assess Quality of Life in Patients With Lymphedema and Venous Ulcers Using CIVIQ-2 Self Questionnaire|Study was terminated due to inadequate enrollment. No data was collected for this outcome measure.|30 days|Study was terminated due to inadequate enrollment. No data was collected for this outcome measure.||||||
2590129|NCT02287376|Secondary|Safety Outcome (5.1 of 7)|• Changes in vital sign measurements: Temperature (degrees C).|3 months (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||degrees C||Standard Deviation|Mean
2590130|NCT02287376|Secondary|Safety Outcome (4 of 7)|• Deaths|3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)|The Safety population included all subjects who have received at least 1 dose of study drug.|||Participants|||Count of Participants
2590131|NCT02287376|Secondary|Safety Outcome (3 of 7)|• Withdrawals due to AEs|3 months (signed informed consent/assent to 30 days after the last dose of study medication taken)|The Safety population included all subjects who have received at least 1 dose of study drug.|||Participants|||Count of Participants
2590132|NCT02287376|Secondary|Safety Outcome (2 of 7)|• Serious adverse events (SAEs)|3 months (signed informed consent/assent to 30 days post Day 90 or last dose of study medication taken)|The Safety population included all subjects who have received at least 1 dose of study drug.|||Participants|||Count of Participants
2590133|NCT02287376|Secondary|Safety Outcome (1 of 7)|• Treatment emergent AEs (TEAEs)|3 months (time of first dose of study medication taken to 30 days after the last dose of study medication taken)|The Safety population included all subjects who have received at least 1 dose of study drug.|||Participants|||Count of Participants
2590134|NCT02287376|Primary|Pharmacokinetics Outcome (6 of 6)|• AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (min*ng/mL)|6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||min*ng/mL||Standard Deviation|Mean
2590135|NCT02287376|Primary|Pharmacokinetics Outcome (5 of 6)|• AUC 0-t: area under the concentration-time curve from time 0 to last time point (t) where diclofenac could be measured (min*ng/mL)|6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||min*ng/mL||Standard Deviation|Mean
2590136|NCT02287376|Primary|Pharmacokinetics Outcome (4 of 6)|• t1/2: terminal elimination half-life (min)|6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||min||Standard Deviation|Mean
2590137|NCT02287376|Primary|Pharmacokinetics Outcome (3 of 6)|• λz: elimination rate constant associated with the terminal (log linear) portion of the curve (1/min)|6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||1/min||Standard Deviation|Mean
2590138|NCT02287376|Primary|Pharmacokinetics Outcome (2 of 6)|• tmax: time to maximum concentration (min)|6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||min||Standard Deviation|Mean
2590139|NCT02287376|Primary|Pharmacokinetics Outcome (1 of 6)|• Cmax: maximum concentration (ng/mL)|6 hours (pre-dose, 5, 10, 15, 20, 30, 40, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||ng/mL||Standard Deviation|Mean
2590140|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 7).|• Physical examination findings including abnormal clinically significant findings|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented is any new or worsened clinically significant abnormal change from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||Participants|||Count of Participants
2590141|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.24 of 7).|• Changes in clinical laboratory results: Urinalysis - Specific Gravity.|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||Specific Gravity||Standard Deviation|Mean
2590142|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.23 of 7).|• Changes in clinical laboratory results: Urinalysis - pH.|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||pH||Standard Deviation|Mean
2590143|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.22 of 7).|• Changes in clinical laboratory results: Chemistry - Sodium (mmol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
2590144|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.21 of 7).|• Changes in clinical laboratory results: Chemistry - Potassium (mmol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
2590145|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.20 of 7).|• Changes in clinical laboratory results: Chemistry - LDH (U/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||U/L||Standard Deviation|Mean
2590146|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.19 of 7).|• Changes in clinical laboratory results: Chemistry - Glucose (mmol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
2590147|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.18 of 7).|• Changes in clinical laboratory results: Chemistry - Creatinine (umol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||umol/L||Standard Deviation|Mean
2590148|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.17 of 7).|• Changes in clinical laboratory results: Chemistry - Chloride (mmol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
2590149|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.16 of 7).|• Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
2590150|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.15 of 7).|• Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||umol/L||Standard Deviation|Mean
2590151|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.14 of 7).|• Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||mmol/L||Standard Deviation|Mean
2590152|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.13 of 7).|• Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||U/L||Standard Deviation|Mean
2590153|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.12 of 7).|• Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||U/L||Standard Deviation|Mean
2590154|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.11 of 7).|• Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||U/L||Standard Deviation|Mean
2590155|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.10 of 7).|• Changes in clinical laboratory results: Chemistry - Albumin (g/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||g/L||Standard Deviation|Mean
2590156|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.9 of 7).|• Changes in clinical laboratory results: Hematology - Monocytes (%).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Monocytes||Standard Deviation|Mean
2590157|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.8 of 7).|• Changes in clinical laboratory results: Hematology - Lymphocytes (%).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Lymphocytes||Standard Deviation|Mean
2590158|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.7 of 7).|• Changes in clinical laboratory results: Hematology - Neutrophils (%).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Neutrophils||Standard Deviation|Mean
2590159|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.6 of 7).|• Changes in clinical laboratory results: Hematology - Eosinophils (%).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Eosinophils||Standard Deviation|Mean
2590160|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.5 of 7).|• Changes in clinical laboratory results: Hematology - Basophils (%).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||% Basophils||Standard Deviation|Mean
2590161|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.4 of 7).|• Changes in clinical laboratory results: Hematology - White Blood Cells (10^9/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||10^9/L||Standard Deviation|Mean
2590162|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.3 of 7).|• Changes in clinical laboratory results: Hematology - Platelet Count (10^9/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||10^9/L||Standard Deviation|Mean
2590163|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.2 of 7).|• Changes in clinical laboratory results: Hematology - Hemoglobin (g/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||g/L||Standard Deviation|Mean
2590164|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.1 of 7).|• Changes in clinical laboratory results: Hematology - Hematocrit (L/L).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug."|||L/L||Standard Deviation|Mean
2590165|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.5 of 7).|• Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug."|||mmHg||Standard Deviation|Mean
2590166|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.4 of 7).|• Changes in vital sign measurements: Systolic Blood Pressure (mmHg).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug."|||mmHg||Standard Deviation|Mean
2590167|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.3 of 7).|• Changes in vital sign measurements: Respiratory Rate (breaths/min).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug."|||breaths/min||Standard Deviation|Mean
2590168|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.2 of 7).|• Changes in vital sign measurements: Pulse Rate (beats/min).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug."|||beats/min||Standard Deviation|Mean
2590169|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.1 of 7).|• Changes in vital sign measurements: Temperature (degrees C).|4 weeks (signed informed consent/assent to the final visit)|"The Safety population included all subjects who have received at least 1 dose of study drug.~The data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug."|||degrees C||Standard Deviation|Mean
2590170|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 7).|• Deaths|4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)|The Safety population included all subjects who have received at least 1 dose of study drug.|||Participants|||Count of Participants
2590171|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 7).|• Withdrawals due to AEs|4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)|The Safety population included all subjects who have received at least 1 dose of study drug.|||Participants|||Count of Participants
2590172|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 7).|• Serious adverse events (SAEs)|4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)|The Safety population included all subjects who have received at least 1 dose of study drug.|||Participants|||Count of Participants
2590173|NCT02287350|Secondary|To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 7).|• Treatment emergent AEs (TEAEs)|4 weeks (first dose of study drug and up to 30 days after the date of the last dose of study drug)|The Safety population included all subjects who have received at least 1 dose of study drug.|||Participants|||Count of Participants
2590174|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (8 of 8).|• Vz/F: apparent volume of distribution (mL).|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||mL||Standard Deviation|Mean
2590175|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 8).|• CL/F: apparent clearance (mL/hr).|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||mL/hr||Standard Deviation|Mean
2590176|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6 of 8).|• AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (hr*ng/mL)|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||hr*ng/mL||Standard Deviation|Mean
2590177|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5 of 8).|• AUC 0-t: area under the concentration-time curve from time 0 to last time point (t) where diclofenac could be measured (hr*ng/mL)|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||hr*ng/mL||Standard Deviation|Mean
2590178|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 8).|• t1/2: terminal elimination half-life (hr)|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||hr||Standard Deviation|Mean
2590179|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 8).|• λz: elimination rate constant (1/hr)|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||1/hr||Standard Deviation|Mean
2590180|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 8).|• Tmax: time to maximum concentration (hr)|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||hr||Full Range|Median
2590181|NCT02287350|Primary|To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 8).|• Cmax: maximum concentration (ng/mL)|6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)|The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.|||ng/mL||Standard Deviation|Mean
2590207|NCT02286921|Secondary|Time to Prostate-Specific Antigen Progression|Reported as number of months till Prostate-Specific Antigen increase of greater or equal to 50% according to Prostate Cancer Working Group (PCWG2) criteria.|Up to 2 years|Date is not evaluable for this outcome measure in 3/94 participants from arm A and 3/101 participants from arm B.|||month||95% Confidence Interval|Median
2590402|NCT02284347|Secondary|Device Safety Profile as Measured by the Overall Adverse Event Rate|Overall adverse event rate|2 weeks||||Percentage of participants with an AE|||Number
2590182|NCT02287038|Primary|The Adult ADHD Quality of Life-29 (AAQOL-29, Brod et al, 2006)|"The Adult ADHD Quality of Life-29 (AAQOL-29, Brod et al, 2006): AAQoL-29 is a 29-item questionnaire designed to assess quality of life and was a secondary efficacy measure in this trial. It is a participant-reported outcome measure used to examine disease specific functional impairments and quality of life for adults with ADHD. The AAQoL is scored as an overall total score, measuring Life Productivity, Psycholofical Health, Relationship, and Life Outlook. Each item is rated by patients on a 5-point Likert scale ranging from Not at all/Never (1) to Extremely/Very Often (5). To derive overall scores, item scores are transformed to a 0-100-point scale (1=0; 2=25; 3=50; 4=75; 5=100). Then, the item scores are summed up and divided by item count to generate overall scores. The score range from 0 to 100. A higher score indicates greater QoL and better functioning."|Visit 1 (Day1), 4(Day 36), 7 (Day 71)|The 36 patients that completed at least one phase of the study were included in the final analyses. The 8 participants did not finish the first phase, and data were not collected on those 8 subjects on the week 4 and week 7. Therefore, the 8 subjects were not entered to the final analysis.|||units on a scale||Standard Deviation|Mean
2590183|NCT02287038|Primary|Conners' Adult ADHD Rating Scales-Self-Report: Short Version (CAARS-S:S, Conner et al, 1999)|Conners' Adult ADHD Rating Scales-Self-Report: Short Version (CAARS-S:S, Conner et al, 1999): The CAARS-S:S is a 26-item questionnaire that assesses symptoms of ADHD in persons aged 18 years or older. T-scores above 65 indicate a likelihood of moderate to severe ADHD symptoms and impairment. The range for the CAARS-S:S is from 0 to 78. A score of 78 would resemble the worst symptoms of ADHD with a score 0 having no symptoms.|Visit 1, (Day1), Visit 4(Day 36), Visit 7 (Day 71)|The 36 patients that completed at least one phase of the study were included in the final analyses. The 8 participants did not finish the first phase, and data were not collected on those 8 subjects on the week 4 and week 7. Therefore, the 8 subjects were not entered to the final analysis.|||units on a scale||Standard Deviation|Mean
2590184|NCT02287025|Secondary|Satisfaction of Investigator/Nurse With Enhanced Drug-specific Information Via SMART Questionnaire|Investigator comfort of managing adverse events, adjusting dosing schedule, and satisfaction with SMART application measured by a questionnaire; 10 categories were answered on a 1 - 7 scale.|Up to 1 year|The study was pre-maturely terminated. No data were collected from participants for this assessment.||||||
2590185|NCT02287025|Secondary|Investigator Comfort With the Use of Regorafenib and Management of AEs as Measured by Questionnaire|Investigator comfort of managing adverse events, adjusting dosing schedule, and satisfaction with SMART application measured by a questionnaire; 10 categories were answered on a 1 - 7 scale.|Up to 1 year|The study was pre-maturely terminated. No data were collected from participants for this assessment.||||||
2590186|NCT02287025|Secondary|Incidence of Grade 3 Hand-foot-skin Reaction (HFSR), Fatigue, Diarrhea, Hypertension|Documented during visits as part of the interval history. All AEs will be reported in the CRF with a diagnosis, start/stop dates, action taken.|Up to 1 year|The study was pre-maturely terminated. No data were collected from participants for this assessment.||||||
2590187|NCT02287025|Secondary|Dose Intensity as Percentage of Planned Dose|Dose level 0 (standard starting dose) @ 160mg po qd. Dose level - 1 @ 120 mg po qd. Dose level - 2 @ 80 mg po qd. This schedule reflects the FDA-approved dosing specified in the prescribing information.|Up to 1 year|The study was pre-maturely terminated. No data were collected from participants for this assessment.||||||
2590188|NCT02287025|Secondary|Duration of Treatment||Up to 1 year|The study was pre-maturely terminated. No data were collected from participants for this assessment.||||||
2590189|NCT02287025|Primary|Proportion of Patients Who Discontinue Prior to Documented Progression of Disease (PD) or Death||Up to 1 year|The study was pre-maturely terminated. No data were collected from participants for this assessment.||||||
2590190|NCT02286960|Secondary|Number of Participants That Showed Improved (Lower) Average Decibels (db) Output.||2 months||||Participants|||Count of Participants
2590191|NCT02286960|Secondary|Change in Voice Handicap Index (VHI) Scores From Baseline to 2 Months.|"A change in VHI scores from pre-treatment to following treatment.~Scores can range from 0-120:~0-30: Mild Minimal amount of handicap 31-60: Moderate Often seen in patients with vocal nodules, polyps, or cysts 60-120: Severe Often seen"|Pre-treatment/baseline to following treatment/2 months||||score on a scale||Full Range|Mean
2590192|NCT02286960|Secondary|Change in Lesion Size From Baseline to 2 Months|Still images of the glottis will be obtained from the video such that the vocal folds are captured in an open position (at least 40 degrees at the anterior commissure). Image J software (NIH) will then be used to outline the lesion and measure the length of the ipsilateral vocal fold.|pre-treatment/baseline to 2 months||||mm||Standard Deviation|Mean
2590193|NCT02286960|Primary|Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score From Baseline to 2 Months|Data will be collected via measurement of the hatchmark on the 100mm line for each variable (e.g. 72/100). The higher the score, the higher the deviancy. The final score is the average of scores from each variable.|pre-treatment/baseline to 2 months||||score on a scale||Standard Deviation|Mean
2590194|NCT02286947|Secondary|Number of Participants With Abnormalities in Echocardiograms (ECHO)|"Standard, 2-dimensional ECHOs were performed at a consistent time of day throughout the study. The ECHO was reviewed and interpreted by medically qualified personnel using a central vendor according to prespecified criteria. Ejection fraction was noted. The Investigator reviewed the results of the ECHO report and determined if the findings were clinically significant.~LEVF=left ventricular ejection fraction"|Baseline up to 100 weeks|Analysis was performed on safety population included all participants who received at least 1 dose of eteplirsen.|||Participants|||Count of Participants
2590195|NCT02286947|Secondary|Number of Participants With Abnormalities in Electrocardiograms (ECGs)|"Twelve-lead ECGs and Holter ECGs were performed at a consistent time of day throughout the study. Electrocardiograms were performed only after the patient was in the supine position, resting, and quiet for a minimum of 15 minutes. The ECG was manually reviewed and interpreted by medically qualified personnel using a central vendor according to prespecified criteria. The Investigator reviewed the results of the centrally read ECG report and determined if the findings were clinically significant. Data is only reported for parameters in which at least 1 participant had potentially clinically significant abnormal ECG findings.~msec=milliseconds; QTcF=QT interval corrected with Fridericia's method"|Baseline up to 100 weeks|Analysis was performed on safety population included all participants who received at least 1 dose of eteplirsen.|||Participants|||Count of Participants
2590196|NCT02286947|Secondary|Number of Participants With at Least One Potentially Clinically Significant Abnormalities in Physical Examinations|Physical examinations, full and brief, were performed by the Investigator, a physician Sub-Investigator, or a Nurse Practitioner (if licensed in the state or province to perform physical examinations). Full physical examinations included examination of general appearance; head, ears, eyes, nose, and throat; heart; lungs; chest; abdomen; skin; lymph nodes; and musculoskeletal and neurological systems. Brief physical examinations included examination of general appearance; head, ears, eyes, nose, and throat; heart; lungs; chest; abdomen; and skin.|Baseline up to 100 weeks||||Participants|||Count of Participants
2590197|NCT02286947|Secondary|Number of Participants With Potentially Clinically Significant Abnormalities in Vital Signs|Vital sign parameters included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and body temperature. Data is only reported for parameters in which at least 1 participant had potentially clinically significant abnormal vital sign findings.|Baseline up to 100 weeks|Analysis was performed on safety population included all participants who received at least 1 dose of eteplirsen.|||Participants|||Count of Participants
2590198|NCT02286947|Secondary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities|"Laboratory parameters included hematology, clinical chemistry, urinalysis and coagulation. Data is only reported for parameters in which at least 1 participant had potentially clinically significant abnormal findings.~Incr=increase; LLN=lower limit of normal; ULN=upper limit of normal; GGT=gamma glutamyl transferase"|Baseline up to 100 weeks|Analysis was performed on safety population included all participants who received at least 1 dose of eteplirsen.|||Participants|||Count of Participants
2590199|NCT02286947|Primary|Number of Participants With Treatment Emergent Adverse Events|An adverse event (AE) was any untoward medical occurrence in a participant that did not necessarily have a causal relationship with the study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes: death; Life-threatening event; Required or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events that developed or worsened during the on-treatment period (defined as time from first dose of study drug and up to 28 days after last dose of study drug (up to 100 weeks) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|From first dose of drug up to 100 weeks|Analysis was performed on safety population included all participants who received at least 1 dose of eteplirsen.|||Participants|||Count of Participants
2590200|NCT02286921|Secondary|Pain Interference as Assessed by the Brief Pain Inventory|Interference is calculated by adding the scores for questions 8a, b, c, d, e, f and g and then dividing by 7. This gives an interference score out of 10, higher score indicates more pain interference.|1 year|"For Arm A, the data was only collected from 82/94 at baseline, 78/94 at month 1, 65/94 at month 3, 53/94 at month 6, 17/94 at month 12.~For Arm B, the data was only collected from 91/101 at baseline, 81/101 at month 1, 76/101 at month 3, 55/101 at month 6, 25/101 at month 12."|||score on a scale||Standard Deviation|Mean
2590201|NCT02286921|Secondary|Pain Severity as Assessed by the Brief Pain Inventory|Severity is calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4. This gives a severity score out of 10, high score indicates more severe pain.|1 year|"For Arm A, the data was only collected from 85/94 at baseline, 78/94 at month 1, 67/94 at month 3, 54/94 at month 6, 17/94 at month 12.~For Arm B, the data was only collected from 92/101 at baseline, 82/101 at month 1, 76/101 at month 3, 54/101 at month 6, 24/101 at month 12."|||score on a scale||Standard Deviation|Mean
2590202|NCT02286921|Secondary|Quality of Life as Assessed by FACIT Fatigue Scale|The Functional Assessment of Chronic Illness Therapy - Fatigue has a score range of 0-52 with higher scores indicating better quality of life.|up to 1 year|Questionnaires were not completed by all participants. Therefore, data was only collected from: 84/94 at month 1, 76/94 at month 3, 55/94 at month 6 and 18/94 at month 12.Arm B- 87/101 at month 1, 81/101 at month 3, 56/101 at month 6 and 25/101 at month 12|||score on a scale||Standard Deviation|Mean
2590203|NCT02286921|Secondary|Quality of Life as Assessed by Short Form 36|All questions are scored on a scale from 0 to 100. The total score from all of the questions answered is divided by the total number of the questions answered yielding a global score from 0-100 with 100 representing the highest level of functioning possible.|up to 1 year|Questionnaires were not completed by all participants. Therefore, data was only collected from: Arm A- 89/94 at baseline, 84/94 at month 1, 74/94 at month 3, 55/94 at month 6 and 18/94 at month 12.Arm B- 96/101 at baseline, 86/101 at month 1, 81/101 at month 3, 56/101 at month 6 and 25/101 at month 12.|||score on a scale||Standard Deviation|Mean
2590204|NCT02286921|Secondary|Change in Quality of Life as Assessed by the International Index of Erectile Function (IIEF) Questionnaire|The IIEF assesses erectile function (EF), orgasmic function (OF), sexual desire (SD), intercourse satisfaction (IS), orgasmic satisfaction (OS). Each of domains are scored on a scale of 0 to 5 with a lower score indicating a bad quality sex life. The IIEF questionnaire has a total score that ranges from 5 to 25 with lower score indicating less erectile dysfunction. A positive change in the score reflects better outcome.|up to 1 year|Questionnaires were not completed by all participants. Therefore, data was only collected from: Arm A- 72/94 at baseline to month 1, 63/94 at month 3, 42/94 at month 6, and 14/94 at month 12. Arm B- 74/101 at month 1, 57/101 at month 3, 46/101 at month 6 and 20/101 at month 12.|||score on a scale||Standard Deviation|Mean
2590205|NCT02286921|Secondary|Quality of Life as Assessed by the Negative Affect Score of the Positive and Negative Affect Schedule (PANAS)|The Negative Affect Score is calculated by adding the scores on items 2, 4, 6, 7, 8, 11, 13, 15, 18, and 20. Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.|up to 1 year|Questionnaires were not completed by all participants. Therefore, data was only collected from: Arm A- 87/94 at baseline, 81/94 at month 1, 71/94 at month 3, 54/94 at month 6 and 17/94 at month 12.Arm B- 93/101 at baseline, 86/101 at month 1, 75/101 at month 3, 55/101 at month 6 and 25/101 at month 12.|||score on a scale||Standard Deviation|Mean
2590206|NCT02286921|Secondary|Quality of Life as Assessed by the Positive Affect Score of the Positive and Negative Affect Schedule (PANAS)|The Positive Affect Score is calculated by adding the scores on items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19. Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.|up to 1 year|Questionnaires were not completed by all participants. Therefore, data was only collected from: Arm A- 87/94 at baseline, 81/94 at month 1, 71/94 at month 3, 54/94 at month 6 and 17/94 at month 12. Arm B- 93/101 at baseline, 86/101 at month 1, 75/101 at month 3, 55/101 at month 6 and 25/101 at month 12.|||score on a scale||Standard Deviation|Mean
2590208|NCT02286921|Secondary|Objective Response Rate as Determined by RECIST|Number of participants with partial (PR) or complete response (CR) as defined by response evaluation criteria in solid tumors (RECIST), where CR is a disappearance of all target lesions and PR is ≥30% reduction in the sum of the longest diameter of target lesions.|Up to 2 years|Only participants with at least one post-baseline assessment were included to assess this outcome measure. Data was not evaluable in 61/94 participants from arm A and 77/101 participants from arm B.|||Participants|||Count of Participants
2590209|NCT02286921|Secondary|Prostate-Specific Antigen Response Rate|Number of participants achieving a Prostate-Specific Antigen decline ≥ 50% according to Prostate Cancer Working Group (PCWG2) criteria.|Up to 2 years|Data was not evaluable for this outcome measure in 7/94 participants from arm A and 7/101 participants from arm B.|||Participants|||Count of Participants
2590210|NCT02286921|Primary|Radiographic Progression|Number of months until 20% increase in the sum of target lesions on CT scans.|up to 2 years||||months||Full Range|Median
2590211|NCT02286921|Primary|Progression Free Survival as Measured by Number of Months Until Clinical or Radiographic Progression|"Time to clinical progression will be defined as months from randomization to any of the following (whichever occurs earlier):~Cancer pain requiring initiation of chronic administration of opiate analgesia (oral opiate use for ≥3 weeks; parenteral opiate use for ≥7 days. Patients with cancer pain requiring opiate analgesia for relief should also be assessed by the investigator for the need for initiating systemic chemotherapy or palliative radiation.~Development of a skeletal-related event (SRE): pathologic fracture, spinal cord compression, or need for surgical intervention or radiation therapy to the bone.~Development of clinically significant symptoms due to loco-regional tumor progression (e.g. urinary obstruction) requiring surgical intervention or radiation therapy."|up to 2 years||||months||Full Range|Median
2590212|NCT02286895|Secondary|Number/Percentage of Participants Experiencing Serious Adverse Events (SAE)|Occurring from vaccination through 3 months post-vaccination, identified or observed by study staff and/or reported by a parent at any time. Serious adverse events were graded for severity and sub-categorized as those deemed related to vaccination or not by the investigator.|3 months post-vaccination|Among all subjects enrolled (intent-to-treat population)|||Participants|||Count of Participants
2590213|NCT02286895|Secondary|Number of Solicited Adverse Reactions (AR) Experienced by Participants|identified or observed by study staff during home visits and/or reported by a parent at any time. Solicited adverse reactions were graded and sub-categorized as those deemed related to vaccination or not by the investigator.|7 days post-vaccination||||systemic reaction|systemic reaction||Count of Units
2590214|NCT02286895|Secondary|Number/Percentage of Participants Experiencing Immediate Reactions Post-vaccination|With emphasis on allergic reactions, observed by study staff|Within 30 minutes post-vaccination|Among all subjects enrolled (intent-to-treat population)|||Participants|||Count of Participants
2590215|NCT02286895|Secondary|Geometric Mean of Anti-rotavirus IgG Among Subjects With <20 Units/mL Concentration at Baseline|Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.|28 days post-vaccination|Participants with valid measures of anti-rotavirus IgG <20 units/mL at baseline|||titer||95% Confidence Interval|Geometric Mean
2590216|NCT02286895|Secondary|Geometric Mean of Anti-rotavirus IgA Among Subjects With <20 Units/mL Concentration at Baseline|Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.|28 days post-vaccination||||titer||95% Confidence Interval|Mean
2590217|NCT02286895|Secondary|Geometric Mean of Anti-rotavirus IgG Concentration|Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.|28 days post-vaccination|Number of subjects with valid measurements (per protocol)|||titer||95% Confidence Interval|Geometric Mean
2590218|NCT02286895|Secondary|Geometric Mean of Anti-rotavirus IgA Concentration|Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.|28 days post-vaccination|Number of subjects with valid measurements (per protocol)|||titer||95% Confidence Interval|Geometric Mean
2590219|NCT02286895|Secondary|Number/Percentage of Subjects With Anti-rotavirus IgG <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28|Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.|28 days post-vaccination|Participants with valid measures of anti-rotavirus IgA <20 units/mL at baseline|||Participants|||Count of Participants
2590220|NCT02286895|Secondary|Number/Percentage of Subjects With Anti-rotavirus IgG Titer of ≥20 Units/mL|Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.|28 days post-vaccination|Number of subjects with valid measurements (per protocol)|||Participants|||Count of Participants
2590221|NCT02286895|Secondary|Number/Percentage of Subjects With Anti-rotavirus IgG Titer at Least 3 Times Baseline Value|Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.|28 days post-vaccination||||Participants|||Count of Participants
2590222|NCT02286895|Secondary|Number/Percentage of Subjects With Anti-rotavirus IgA <20 Units/mL at Baseline Visit That Had >=20 Units/mL at Day 28|Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.|28 days post-vaccination|Participants with valid measures of anti-rotavirus IgA <20 units/mL at baseline|||Participants|||Count of Participants
2590223|NCT02286895|Secondary|Number/Percentage of Subjects With Anti-rotavirus IgA Titer of ≥20 Units/mL|Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.|28 days post-vaccination|Number of subjects with valid measurements (per protocol)|||Participants|||Count of Participants
2590224|NCT02286895|Secondary|Number/Percentage of Subjects With Anti-rotavirus Immunoglobulin A (IgA) Titer at Least 3 Times Baseline Value|Conducted by validated Enzyme Linked Immunosorbent Assay (ELISA). The pre- and post-vaccination samples were to be evaluated in one run for consistency and each specimen was to be tested with a negative control for better specificity.|28 days post-vaccination|Number of subjects with valid measurements (per protocol)|||Participants|||Count of Participants
2590225|NCT02286895|Secondary|Geometric Mean of Meningitis Serum Bactericidal Antibody Titer|Measured using baby rabbit complement (rSBA).|Baseline to Day 28|Number of subjects with valid measurements (per protocol)|||titer||95% Confidence Interval|Geometric Mean
2590226|NCT02286895|Secondary|Number/Percentage of Subjects With Seroresponses for Meningitis Conjugate Serum Bactericidal Antibody (SBA)|Seroresponse was defined as a geometric mean titer (GMT) of at least four times baseline value. Measured using baby rabbit complement (rSBA).|28 days post-vaccination|Number of subjects with valid measurements (per protocol)|||Participants|||Count of Participants
2590227|NCT02286895|Secondary|Serum Neutralization Geometric Mean Titers for Yellow Fever Vaccine|Measured by virus neutralization assay, determined using Robert Koch Institute's yellow fever standard of practice (SOP) and relative to international scientific references for which the level of anti-YF neutralizing IgG protection was known.|28 days post-vaccination|Number of subjects with valid measurements (per protocol)|||titer||95% Confidence Interval|Geometric Mean
2590228|NCT02286895|Secondary|Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody|Measured using a commercially-available Enzyme Linked Immunosorbent Assay (ELISA). Seroconversion was defined as a measurement ≥1.10 geometric mean titer (GMT) at Day 28 among subjects with measurement ≤0.90 at baseline.|3 months post-vaccination|Subjects with valid measurements and measurement ≤0.90 at baseline (per protocol)|||Participants|||Count of Participants
2590229|NCT02286895|Primary|Number/Percentage of Subjects With Seroresponses for Yellow Fever Neutralizing Antibody|Measured by virus neutralization assay, determined using Robert Koch Institute's yellow fever standard of practice and relative to international scientific references for which the level of anti-YF neutralizing IgG protection was known. Seroresponse was defined as a geometric mean titer (GMT) of at least four times baseline value.|28 days post-vaccination|Number of subjects with valid measurements and negative result at baseline (per protocol)|||Participants|||Count of Participants
2590230|NCT02286895|Primary|Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody|Measured using a commercially-available Enzyme Linked Immunosorbent Assay (ELISA). Seroconversion was defined as a measurement ≥1.10 geometric mean titer (GMT) at Day 28 among subjects with measurement ≤0.90 at baseline|28 days post-vaccination|Number of subjects with valid measurements and measurement ≤0.90 at baseline (per protocol)|||Participants|||Count of Participants
2590231|NCT02286713|Secondary|Mean Value: Knowledge of Lung Cancer Screening|A 12-item, self-report measure of the patient's knowledge of facts related to lung cancer and lung cancer screening, including the harms and benefits of testing. The knowledge scale yields a single score, representing the percentage of correct responses (ranging from 0% to 100% correct). Higher scores indicate greater knowledge.|One week to 6 months, assessments at 1-week, 3-months and 6-months follow-up.|For the participants providing data at the 1-week follow-up, no data was missing in either group.|||percentage of correct responses||Standard Deviation|Mean
2590232|NCT02286713|Primary|Mean Value: Values Clarity Subscale of the Decisional Conflict Scale©|A 3-item subscale that measures the degree to which the patient feels clear about his or her values related to the lung cancer screening decision, including values about the harms and benefits. Total scores range from 0 (feels extremely clear about personal value for benefits and risks/side effects of screening) 100 (feels extremely unclear about personal value for benefits and risks/side effects of screening) related to making a decision. The scale was adapted for the LCS context.|Assessment at 1-week follow-up.|Of participants providing data at the 1-week follow-up, one participant in the Standard Educational Information group did not answer the Values Clarity Subscale questions and was dropped from the analysis and where one participant in the Decision Aid Arm did not answer the scale questions and was dropped from the analysis.|||units on a scale||Standard Deviation|Mean
2590233|NCT02286713|Primary|Mean Value: Informed Subscale of the Decisional Conflict Scale©|A 3-item subscale that measures the degree to which the patient feels informed in making a decision about lung cancer screening. Total scores range from 0 (feels extremely informed) to 100 (feels extremely uninformed) related to making a decision. The scale was adapted for the LCS context.|Assessment at 1-week follow-up.|All participants providing data at the 1-week follow-up where one participant in the Decision Aid Arm did not answer the scale questions and was dropped from the analysis.|||units on a scale||Standard Deviation|Mean
2590234|NCT02286713|Primary|Mean Value: Preparation for Decision Making© Scale|The Preparation for Decision Making© Scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation visit and making a health decision. The scale is scored by summing the 10 items and dividing by 10. Scores are then converted to a 0-100 scale by subtracting 1 and multiplying by 25. Higher scores indicate higher perceived level of preparation for decision making. For this study, researchers used the patient version of the Preparation for Decision Making© scale, adapted for Lung Cancer Screening (LCS) context.|Assessment at 1-week follow-up.|Of participants providing data at the 1-week follow-up, seventeen(17) of the participants did not answer the scale items and were therefore dropped from analysis.|||units on a scale||Standard Deviation|Mean
2590235|NCT02286518|Secondary|Urinary Excretion Ratio of TAK-114 From 0 to 48 Hours Postdose: Part 1|Urinary excretion ratio (% of dose) of TAK-114 in urine were calculated for each participant. Ratio was calculated from the urine concentrations of each analyte and the volume of urine collected.|Day 1: 0 to 48 hours postdose|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.|||percentage of dose||Standard Deviation|Mean
2590391|NCT02284464|Secondary|Mean Score on the Protocol Biopsies in the Two Treatment Groups|Measurement at 24 months according to the Banff classification. The Banff Classification of Allograft Pathology is an international consensus classification for the reporting of biopsies from solid organ transplant. The scale ranges from 0 to 3, 3 being the worst.|24 months||||score on a scale||Standard Deviation|Mean
2590236|NCT02286518|Secondary|Mean R(AUC): Mean of Accumulation Coefficient of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-114: Part 3|Mean R(AUC) was estimated as the ratio of AUC(0-tau) on Day 10 and AUC(0-tau) on Day 1. AUC (0-tau) is the area under the plasma concentration-time curve from time 0 to time tau.|Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.|||ratio||Standard Deviation|Mean
2590237|NCT02286518|Secondary|Mean R(Cmax): Mean Accumulation Coefficient of Observed Maximum Plasma Concentration for TAK-114: Part 3|Mean R(Cmax) was estimated as the ratio of Cmax on Day 10 and Cmax on Day 1. Cmax is the peak plasma drug concentration of TAK-114.|Days 1 and 10: predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.|||ratio||Standard Deviation|Mean
2590238|NCT02286518|Secondary|Mean Terminal Phase Elimination Half-life (T1/2) for TAK-114||Day1:predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10: predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.|||hour||Standard Deviation|Mean
2590239|NCT02286518|Secondary|AUC (0-tau) - Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau for TAK-114: Part 3||Day10: predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.|||pg*hr/mL||Standard Deviation|Mean
2590240|NCT02286518|Secondary|AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2||Day 1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.|||picogram*hour per milliliter (pg*hr/mL)||Standard Deviation|Mean
2590241|NCT02286518|Secondary|Cmax - Maximum Observed Plasma Concentration for TAK-114||Day1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10:predose and at multiple time points (up to 12 hours) postdose for Part 3|The Pharmacokinetic (PK) analysis set includes all participants who had received the study drug and met the essential requirements defined in the study protocol without any critical protocol violations, and in whom PK assessment was possible.|||picogram per milliliter (pg/mL)||Standard Deviation|Mean
2590242|NCT02286518|Primary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis||Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3|The safety analysis set includes all participants who received the study drug.|||participants|||Number
2590243|NCT02286518|Primary|Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)||Baseline up to Day 2 (only for Cohorts 1A, 2A, and 3A) in Part 1|The safety analysis set includes all participants who received the study drug.|||participants|||Number
2590244|NCT02286518|Primary|Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)|"Number of participants who had ECG shifts from within normal limit at baseline to abnormal, clinically significant after study drug administration were reported."|Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3|The safety analysis set includes all participants who received the study drug.|||participants|||Number
2590245|NCT02286518|Primary|Number of Participants With TEAEs Related to Body Weight||Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3|The safety analysis set includes all participants who received the study drug.|||participants|||Number
2590246|NCT02286518|Primary|Number of Participants With TEAEs Related to Vital Signs||Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3|The safety analysis set includes all participants who received the study drug.|||participants|||Number
2590247|NCT02286518|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)||Baseline up to 3 days after the last dose of study drug (Day 3 in Part 1), (Day 20 in Part 2) and 7 days after the last dose of study drug (Day 17 in Part 3)|The safety analysis set includes all participants who received the study drug.|||participants|||Number
2590248|NCT02286466|Secondary|Change in Depression Symptoms From Baseline to Post-assessment|Patient Health Questionnaire-9 (PHQ-9): The PHQ-9 is a brief, validated measure of major depression per the criteria of the Diagnostic and Statistical Manual of Mental Disorders. Patients respond to 9 questions on a scale of 0 (not at all) to 3 (nearly every day). The total scale score ranges from 0 to 27, with higher scores indicating worse depression symptoms.|1) Baseline (within 2 weeks after enrollment), 2) Post-Assessment (8-12 weeks after baseline)|Analysis population is the number of participants who completed both baseline and post-assessment measures of the Patient Health Questionnaire-9 (PHQ-9).|||Units on a scale||Standard Error|Mean
2590249|NCT02286466|Secondary|Change in Mood Symptoms From Baseline to Post-assessment|Hospital Anxiety & Depression Scale (HADS): The HADS is a self-report instrument that was designed for medical patients and demonstrates adequate psychometric properties for use among individuals with cancer. Comprised of 14-items that are scored on a 4-point Likert scale, the instrument contains two subscales that measure anxiety and depression symptoms in the past week. Total scores for each subscale range from 0 (no distress) to 21 (maximum distress).|1) Baseline (within 2 weeks after enrollment), 2) and Post-Assessment (8-12 weeks after baseline)|Analysis population is the number of participants who completed both baseline and post-assessment measures of the Hospital Anxiety & Depression Scale (HADS).|||Units on a scale||Standard Error|Mean
2590250|NCT02286466|Secondary|Change in Quality of Life From Baseline to Post-assessment|Functional Assessment of Cancer Therapy-General: The FACT-G is a valid and reliable self-report, 27-item instrument, consisting of 4 subscales that evaluate physical, functional, emotional and social wellbeing during the past 7 days. Items are scored using a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). The overall score is the sum of the four subscale scores (range 0-108). Higher scores indicate better quality of life, while lower scores indicate worse quality of life.|1) Baseline (within 2 weeks after enrollment), 2) Post-Assessment (8-12 weeks after baseline)|Analysis population is the number of participants who completed both baseline and post-assessment measures of the Functional Assessment of Cancer Therapy-General (FACT-G).|||Units on a scale||Standard Error|Mean
2590251|NCT02286466|Primary|Change in Anxiety Symptoms From Baseline to Post-assessment|Hamilton Anxiety Rating Scale (HAM-A): The HAM-A is a clinician-administered interview used widely in psychiatry research to evaluate anxiety symptoms. Consisting of 14 items that are scored on a scale from 0 (not present) to 4 (very severe), the HAM-A total score ranges from 0 to 56, with higher scores indicating worse anxiety symptoms.|1) Baseline (within 2 weeks after enrollment), 2) Post-Assessment (8-12 weeks after baseline)|Analysis population is the number of participants who completed both baseline and post-assessment measures of the Hamilton Anxiety Rating Scale (HAM-A).|||Units on a scale||Standard Error|Mean
2590252|NCT02286193|Secondary|Number of Participants Setting a Goal With Their CRS|Number of patients who completed at least one visit with the CRS and set a specific action-based goal with their CRS. Patients could meet with the CRS and receive referrals to resources without setting specific action-based goals. This was assessed by abstraction and coding of CRS documentation in the medical record.|3 months||||participants|||Number
2590253|NCT02286193|Primary|Number of Participants Receiving a Resource for Community Services|Number of patients who completed at least one visit with the CRS and were given a referral for at least one resource, service, or organization. This was assessed by abstraction and coding of CRS documentation in the medical record.|3 months||||participants|||Number
2590254|NCT02286102|Secondary|Hemoglobin Levels, Post-Op Day 2|Hemoglobin levels will be measured post-operatively day 2|2 days postop||||g/Dl (grams/deciliter)||Standard Deviation|Mean
2590255|NCT02286102|Secondary|Hemoglobin Levels, Post-Op Day 3|Hemoglobin levels will be measured post-operatively day 3|3 days postop||||g/Dl (grams/deciliter)||Standard Deviation|Mean
2590256|NCT02286102|Primary|Volume of Allogenic Blood Transfused Postoperatively|The total volume of allogenic blood transfused postoperatively will be measured during the first 48 hours postoperatively while the drains are in place.|48 hours postoperative||||mL||Standard Deviation|Mean
2590257|NCT02285998|Secondary|Number of Participants With Systemic Reactogenicity|Solicited events of systemic reactogenicity reported during Day 0-7.|Days 0 through 7|Solicited systemic reactogenicity events include subjects who recorded any systemic reaction data.|||participants|||Number
2590258|NCT02285998|Secondary|Measure of Post-vaccination HAI GMTs|GMT titers for all four antigens in a preselected subset of subjects.|Days 0 through 28|The immunogenicity population includes all randomized subjects at the specific study sites pre-selected for serology who received study vaccine and provided serum samples on Days 0 and 28 for serologic testing.|||titer||95% Confidence Interval|Geometric Mean
2590259|NCT02285998|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)|"Serious adverse events (SAEs) and medically-attended adverse events (MAEs) occurring during the period of follow-up through the influenza season (at least 6 months post-vaccination).~A MAE is an event that prompts an unplanned visit to a medical professional for diagnosis and/or treatment."|Day 0 through and up to 32 weeks post vaccination|The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine.|||participants|||Number
2590260|NCT02285998|Secondary|Number of Participants With Unsolicited Adverse Events|Unsolicited adverse events reported in the 28 days following vaccine administration.|Days 0 through 28|The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine.|||participants|||Number
2590261|NCT02285998|Secondary|Number of Participants With Local Injection Site Reactogenicity|Solicited events of injection site reactogenicity reported during Day 0-7.|Days 0 through 7|Solicited local reactogenicity events include subjects who recorded any injection site reaction data.|||participants|||Number
2590262|NCT02285998|Secondary|Percentage of Participants With Seroconversion|Seroconversion rates (SCR) for all four antigens in a preselected subset of subjects.|Days 0 through 28|The immunogenicity population includes all randomized subjects at the specific study sites pre-selected for serology who received study vaccine and provided serum samples on Days 0 and 28 for serologic testing.|||percentage of participants||95% Confidence Interval|Number
2590263|NCT02285998|Secondary|Number of Participants With rtPCR-confirmed CDC-defined Influenza-Like Illness|rtPCR-confirmed CDC-defined ILI that begins at least 14 days post-vaccination caused by any influenza strain.|14 days post vaccination through and up to 32 weeks post vaccination|The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.|||participants|||Number
2590264|NCT02285998|Secondary|Number of Participants With Culture-confirmed CDC-defined Influenza-Like Illness|"Culture-confirmed CDC-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those in the study vaccines.~CDC-defined ILI is defined as body temperature ≥100°F accompanied by cough and/or sore throat."|14 days post vaccination through and up to 32 weeks post vaccination|The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.|||participants|||Number
2590392|NCT02284464|Primary|Cases of Kidney Transplant Patients With DSA|Measurements of DSA at baseline, and at 3, 6, 12, 18 and 24 months|24 months||||Participants|||Count of Participants
2590393|NCT02284399|Secondary|Frequency of Positive Tests for Abnormal Karyotype Before and After the Adoption of NIPT Testing.|Will determine if frequency of positive tests for abnormal karyotypes between the control period and the study period where different.|4 years|The number of positive tests identified between the control and the test periods.|||Participants|||Count of Participants
2590265|NCT02285998|Secondary|Number of Participants With Culture-confirmed Influenza-Like Illness|"Culture-confirmed protocol-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those strains represented in the study vaccines.~Protocol-defined ILI is defined as at least one of the following respiratory symptoms accompanied by at least one of the following systemic symptoms:~Respiratory symptoms: sore throat, cough, sputm production, wheezing, difficulty breathing Systemic symptoms: fever, chills (shivering), tiredness (fatigue), headache, myalgia (muscle ache)"|14 days post vaccination through and up to 32 weeks post vaccination|The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.|||participants|||Number
2590266|NCT02285998|Primary|Number of Participants With rtPCR-confirmed Influenza-Like Illness|rtPCR-confirmed, protocol-defined Influenza-Like Illness (ILI) caused by any influenza strain that begins at least 14 days post-vaccination|14 days post vaccination through and up to 32 weeks post vaccination|The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.|||participants|||Number
2590267|NCT02285920|Secondary|Safety - Combined Incidence of Potassium >6.5 mEq/L or Serious Hyperkalemia|The number of participants who had serum potassium >6.5 mEq/L or serious hyperkalemia was assessed by treatment arm.|0 - 40 Weeks||||Participants|||Count of Participants
2590268|NCT02285920|Secondary|Efficacy - Secondary Cardiac Outcome Measures - Left Ventricular Global Longitudinal Strain (LVGLS)|"Secondary outcome measures include other echocardiographic markers of systolic and diastolic function,~• Change in myocardial strain and strain rate between baseline and 36 weeks"|Baseline - 36 weeks|The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points.|||% of myocardial shortening||Standard Deviation|Mean
2590269|NCT02285920|Secondary|Efficacy - Secondary Cardiac Outcome Measures - Ratio of Mitral Peak Velocity to Diastolic Mitral Annular Velocity (E/E')|"Secondary outcome measures include other echocardiographic markers of systolic and diastolic function,~• E/E' is the ratio of mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E')"|Baseline - 36 weeks|The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points.|||ratio||Standard Deviation|Mean
2590270|NCT02285920|Secondary|Efficacy - Secondary Cardiac Outcome Measures Left Ventricular Mass Index (LVMI)|"Secondary outcome measures include other echocardiographic markers of systolic and diastolic function,~• Change in left ventricular mass index (LVMI) between baseline and 36 weeks"|Baseline - 36 weeks|The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points.|||g/m^2||Standard Deviation|Mean
2590271|NCT02285920|Secondary|Efficacy - Secondary Cardiac Outcome Measure - Left Ventricular Ejection Fraction (LVEF)|"Secondary outcome measures include other echocardiographic markers of systolic and diastolic function~• Change in left ventricular ejection fraction between Baseline and 36 weeks"|Baseline - 36 weeks|The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points.|||percent ejection fraction||Standard Deviation|Mean
2590272|NCT02285920|Secondary|Safety - Cardiovascular Death|Number of Cardiovascular deaths defined as death due to myocardial infarction, congestive heart failure, cardiac valvular disease, arrhythmia, sudden death, stroke, or peripheral arterial disease|0 - 40 weeks||||Participants|||Count of Participants
2590273|NCT02285920|Secondary|Safety - Inter- or Intra-dialytic Hypotension|"Inter- or intra-dialytic hypotension defined as:~Inter-dialytic: systolic blood pressure <90 mm Hg or inter-dialytic hypotension requiring adjustment in anti-hypertensive medications or treatment in a hospital or emergency room.~Intra-dialytic: systolic blood pressure <80 mm Hg during ≥3 dialysis sessions per 30-day period or treatment for either hypotension or symptoms of hypotension during ≥3 dialysis sessions per 30-day period"|0 - 40 weeks||||Participants|||Count of Participants
2590274|NCT02285920|Secondary|Safety - Hyperkalemia Requiring Adjustment in Treatment|Hyperkalemia requiring adjustment in dialysate potassium concentration, or discontinuation of study medication|0 - 40 weeks||||Participants|||Count of Participants
2590275|NCT02285920|Secondary|Safety - Number of Participants With Serious Hyperkalemia|Number of patients with serious hyperkalemia requiring hospitalization, emergency/unscheduled dialysis or resin therapy|0 - 40 weeks||||Participants|||Count of Participants
2590276|NCT02285920|Primary|Feasibility of Conducting a Full-scale Mortality-powered Trial|An objective of this study is to assess the feasibility of conducting a full-scale mortality-powered trial. Feasibility assessed based on recruitment, dropout and loss to follow-up rates.|0 - 40 weeks||||Participants|||Count of Participants
2590277|NCT02285920|Primary|Efficacy - Change in Mitral Annular E' Velocity|Change in mitral annular E' velocity measured using Tissue Doppler Index (TDI) echocardiography. Efficacy outcomes were considered exploratory with a goal of detecting signals rather than clearly demonstrating efficacy.|Baseline to 36 weeks|The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points.|||cm/second||Standard Deviation|Mean
2590278|NCT02285920|Primary|Study Drug Tolerability|Tolerability is defined as number of participants who experienced permanent study drug discontinuation or dose reduction.|0 - 36 weeks||||Participants|||Count of Participants
2590279|NCT02285920|Primary|Safety - Participants With Serious Hypotension|The number of participants experiencing serious hypotension, defined as hypotension requiring hospitalization or ED visit and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection).|0 - 40 weeks||||Participants|||Count of Participants
2590280|NCT02285920|Primary|Safety - Number of Participants With Serum Potassium >6.5 mEq/L|The number of participants who had serum potassium >6.5 mEq/L was assessed by treatment arm.|0 - 40 weeks||||Participants|||Count of Participants
2590394|NCT02284399|Primary|Number of Patient Undergoing IDTFK Before (Control) and After (Test) NIPT Testing Came to Market|Total Number of patient undergoing invasive diagnostic testing for fetal karyotype (IDTFK) before (control group = Jan - July 2010) and after (test group=Jan 2012-June 2014) NIPT testing came to market|4 years|This was an observational study that looked to compare the number of patient who underwent IDTFK during Jan 2010-July 2010 (prior to the adoption of NIPT) with the number of patients who underwent IDTFK during Jan 2012-June 2014 (after the adoption of NIPT).|||Participants|||Count of Participants
2590281|NCT02285907|Secondary|Plasma Amino Acids|Plasma amino acid concentrations were measured from the pre and hourly postprandial time points until dinner request following the Macronutrient and Fiber Matched BEEF meal and the Serving Size Matched Beef Meal. An average amino acid concentration was then determined from the change from baseline concentration for all available time points. Plasma amino acid analyses were performed through the University of Missouri-Columbia Agricultural Experiment Station Chemical Laboratories using cation-exchange chromatography (cIEC-HPLC) coupled with post-column ninhydrin derivatization and quantitation.|- 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min|Four participants were excluded because of insufficient time points.|||pg/ml||Standard Error|Mean
2590282|NCT02285907|Primary|Food Cue-stimulate fMRI Brain Scans|Participants viewed 3 categories of pictures including food, nonfood (animals), and blurred baseline images. The pictures from each category were presented in blocks of images. Animal pictures were used to control for visual richness and general interest (i.e., appealing but not appetizing). To determine the effects of protein type on neural activity associated with food motivation, repeated measures ANOVAs were performed on the brain activation maps within the Brain Voyager software with use of stimulus [food (i.e., appetizing and appealing) vs. nonfood (i.e., animal, nonappetizing but appealing] and protein source (BEEF vs. SOY) comparisons within the macronutrient and fiber-matched condition and the serving size-matched conditions, separately. The mean percent signal change in the maximum voxel within each region that displayed significant activation after the BEEF and SOY meals was then determined. Talairach coordinates for each region are presented for each row as (x;y;z).|3 hours||||percent signal change||Standard Error|Mean
2590283|NCT02285907|Primary|Net Incremental Area Under the Curve (niAUC) of Plasma Total Glucagon-like Peptide (GLP-1) and Total Peptide YY (PYY)|The samples were collected in test tubes containing ethylenediaminetetraacetic acid. Protease inhibitors (pefabloc SC and dipeptidyl peptidase) were added to some of the tubes to reduce protein degradation. The plasma was separated and stored at -80°C. Plasma total glucagon-like peptide (GLP-1) and peptide YY (PYY) were measured for all time points using the Milliplex multi-analyte profiling magnetic bead-based multi-analyte, metabolic panel, 2-plex assay and Magpix Luminex technologies. niAUC was calculated throughout the testing period by computing the summation of the average change from baseline score (units of pg/ml) for each time point and the subsequent time point, multiplied by the difference in time (units of min) between the two time instances for a total of 20 blood samples.|- 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min||||(pg*min)/ml||Standard Error|Mean
2590284|NCT02285907|Primary|Net Incremental Area Under the Curve (niAUC) of Perceived Hunger and Fullness|"Computerized questionnaires, assessing perceived sensations of hunger and fullness were completed throughout the testing days. The questions are worded as how strong is your feeling of with anchors of not at all to extremely. Each reported score can be a minimum of 0 and a maximum of 100 mm. niAUC was calculated for by computing the summation of the average change from baseline score (units of mm) for each time point and the subsequent time point, multiplied by the difference in time (min) between the two measures. For reported feelings of hunger, a higher score can be interpreted as feeling more hungry. For fullness, higher can be interpreted as feeling more full. Questionnaires were asked at baseline and about every 30 minutes throughout the day for a total of 20 questionnaires."|- 15 min, +0 min,+30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +255 min, +270 min, +285 min, +300 min, +330 min, +360 min, +390 min, +420 min, +450 min, and +480 min||||mm*min||Standard Error|Mean
2590285|NCT02285907|Primary|Subsequent Food Intake|Ad libitum dinner and snacks were provided. Energy content and macronutrient content of these eating occasions were assessed.|1 Day||||kilocalories||Standard Error|Mean
2590286|NCT02285907|Primary|Eating Initiation|Eating initiation will be measured as the time lapse between consuming the intervention and requesting dinner.|1 Day||||minutes||Standard Error|Mean
2590287|NCT02285855|Primary|RECIST and PERCIST Tumor Response|The primary objective is the effect of metformin on response in NSCLC patients treated with hypofractionated RT. All patients will receive FDG-PET/CT scan at baseline (prior to metformin start), prior to RT and at 6 months (+/- 30 days) following RT. PET/CT imaging using [18F]-2-fluoro-2-deoxyglucose positron emission tomography (18F-FDG), using a standard approved radiopharmaceutical dose and administration selected by the nuclear medicine physician (120 min). Response will be determined at 6 months post-treatment via relative change from pre-treatment tumor by Response Evaluation Criteria in Solid Tumor (RECIST) by complete response (CR), partial response (PR) and stable disease (SD) and PET Response Criteria in Solid Tumors (PERCIST) by stable metabolic disease (SMD), progressive metabolic disease (PMD) and complete metabolic response(CMR).|From baseline (prior to metformin start) to Post-Radiotherapy (RT) Treatment, assessed up to 6 months|Three participants did not complete the treatment ( Metformin Arm in 2 and Placebo Arm in 1). 15 participants randomized and completed ( Placebo Arm in 1 and Metformin Arm in 14). One participant died prior post treatment 6 months evaluation.|||Participants|||Count of Participants
2590288|NCT02285777|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs), Medically-attended AEs and AEs Leading to Premature Withdrawal.|The number of subjects reporting any SAEs, medically-attended AEs and AEs leading to premature withdrawal during the entire study period is reported. SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as the occurrence of any unsolicited AE regardless of intensitygrade or relation to vaccination.|During the entire study period (from Day 0 up to Month 10)|Analysis was performed on Safety Set (overall)- included all screened subjects who provide informed consent and demographic and/or baseline screening assessments, received a subject ID and a study vaccination, and have either post-vaccination reactogenicity data or post-vaccination unsolicited adverse event records.|||Participants|||Count of Participants
2590395|NCT02284386|Primary|The Apparent Terminal Elimination Half-life (t1/2el)||Baseline through Day 14||||hours||Standard Deviation|Mean
2590396|NCT02284386|Primary|The Apparent Terminal Elimination Rate Constant (λz)||Baseline through Day 14||||1/hours||Standard Deviation|Mean
2590289|NCT02285777|Secondary|Number of Subjects Reporting Any Unsolicited AEs|The number of subjects reporting unsolicited AEs after any vaccination is reported. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Day 1 to Day 30 after any vaccination|Analysis was performed on Safety set (unsolicited AEs)- included all screened subjects who provided informed consent & demographic and/or baseline screening assessments, received a subject ID and a study vaccination, and had post-vaccination unsolicited adverse event records.|||Participants|||Count of Participants
2590290|NCT02285777|Secondary|Number of Subjects Reporting Any Solicited Local or Systemic Adverse Events (AEs)|Number of subjects reporting any solicited local or systemic AEs from Day 1 (6 hours) to Day 7 after any meningococcal vaccination is reported. Assessed solicited local symptoms were induration, erythema and pain. Assessed solicited general symptoms were fatigue, myalgia, arthralgia, headache, fever, chills and loss of appetite. Other solicited data included prevention of pain/fever and treatment of pain/fever. Any = occurrence of the symptom regardless of intensity grade.|Day 1 (6 hours) to Day 7 after vaccination|Analysis was performed on Safety Set (solicited AEs & other solicited reactions)-included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & a study vaccination, & provided post-vaccination reactogenicity data.|||Participants|||Count of Participants
2590291|NCT02285777|Secondary|Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroups A, C, W, Y, at 4 months after the 3-dose vaccination series.|At Month 10 (4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 10 & whose immunogenicity assay result was available for at least one serogroup A, C, W and Y test strain.|||Percentage of subjects||95% Confidence Interval|Number
2590292|NCT02285777|Secondary|Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 against serogroups A, C, W, Y, at 1 month after the 3-dose vaccination series.|At Month 7 (1 month after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Month 7)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 7 & whose immunogenicity assay result was available for at least one serogroup A, C, W and Y test strain.|||Percentage of subjects||95% Confidence Interval|Number
2590293|NCT02285777|Secondary|Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 4 months after the 3-dose vaccination series.|At Month 10 (4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.|||Percentage of subjects||95% Confidence Interval|Number
2590294|NCT02285777|Secondary|Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 1 month after the 3-dose vaccination series.|At Month 7 (1 month after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Month 7)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 7 & whose immunogenicity assay result was available for at least one serogroup B test strain.|||Percentage of subjects||95% Confidence Interval|Number
2590295|NCT02285777|Secondary|Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y, at 1 and 4 months after the 3-dose vaccination series. The four-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 4 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least four times the pre-vaccination HT-hSBA titers.|At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Months 7 &10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.|||Percentage of subjects||95% Confidence Interval|Number
2590397|NCT02284386|Primary|Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity After Drug Administration (AUC0-∞)||Baseline through Day 14||||hours x ng/mL||Standard Deviation|Mean
2590398|NCT02284386|Primary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Last Collection Time After Drug Administration (AUC0-last)||Baseline through Day 14||||hours x ng/mL||Standard Deviation|Mean
2590399|NCT02284386|Primary|Time to Peak Plasma Concentration (Tmax)||Baseline through Day 14||||hours||Full Range|Median
2590296|NCT02285777|Secondary|Percentage of Subjects With Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C, W and Y at 1 and 4 Months After the 3-dose Vaccination Series.|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a three-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y, at 1 and 4 months after the 3-dose vaccination series. The three-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 3 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least three times the pre-vaccination HT-hSBA titers.|At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Months 7 &10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.|||Percentage of subjects||95% Confidence Interval|Number
2590297|NCT02285777|Secondary|Percentage of Subjects With Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroups A, C,W and Y at 1 and 4 Months After the 3-dose Vaccination Series.|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y at 1 and 4 months after the 3-dose vaccination series. The two-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 2 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least two times the pre-vaccination HT-hSBA titers.|At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)|Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.|||Percentage of subjects||95% Confidence Interval|Number
2590298|NCT02285777|Secondary|Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 4 Months After the 3-dose Vaccination Series|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ LLQ against serogroups A, C, W, Y, at 4 months after the 3-dose vaccination series. The LLQ cut off values for serogroups A, C, W and Y were 22.7,5.2,39.6 and 14.7 respectively.|At Month 10 (4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided informed consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 10 and whose immunogenicity assay result was available for at least one serogroup B strain|||Percentages of subjects||95% Confidence Interval|Number
2590299|NCT02285777|Secondary|Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ LLQ at 1 Month After the 3- Dose Vaccination Series|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ LLQ against serogroups A, C, W, Y, at 1 month after the 3-dose vaccination series.The LLQ cut off values for serogroups A,C,W and Y were 22.7,5.2, 39.6 and 14.7 respectively.|At Month 7 (1 month after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Month 7)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 7 & whose immunogenicity assay result was available for at least one serogroup A, C, W and Y test strain.|||Percentages of subjects||95% Confidence Interval|Number
2590300|NCT02285777|Secondary|HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y.|The immunogenicity of three doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs to serogroups A, C, W, and Y, at 1 and 4 months after the 3-dose vaccination series.|At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Months 7 &10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.|||Titers||95% Confidence Interval|Geometric Mean
2590301|NCT02285777|Secondary|Percentages of Subjects With a Four-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The four-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 4 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least four times the pre-vaccination HT-hSBA titers.|At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Months 7 &10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.|||Percentages of subjects||95% Confidence Interval|Number
2590309|NCT02285777|Secondary|Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at 1 and 4 Months After the 3-dose Vaccination Series.|The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 and 4 months after the 3-dose vaccination series were evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:8 dilution using the hSBA against each strain in MenABCWY Group and MenACWY Group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:8 dilution across all 110 strains.|At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Effectiveness (Months 7 & 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received subject ID & vaccination, & provided evaluable serum sample with the enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain at Months 7 & 10.|||Percentages of subjects|||Number
2590302|NCT02285777|Secondary|Percentages of Subjects With a Three-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a three-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The three-fold titers rise is defined as: a) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 3 LLQ; b) for subjects with pre-vaccination (Month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least three times the pre-vaccination HT-hSBA titers.|At months 7 and 10 (1 and 4 months after 3-dose vaccination series)|Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.|||Percentage of subjects||95% Confidence Interval|Number
2590303|NCT02285777|Secondary|Percentages of Subjects With a Two-fold Rise in HT-hSBA Titers Against the N. Meningitidis Serogroup B Test Strains at 1 and 4 Months After the 3-dose Vaccination Series.|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The two-fold titers rise is defined as: a) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 2 LLQ; b) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least two times the pre-vaccination HT-hSBA titers.|At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)|Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subjects D & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.|||Percentage of subjects||95% Confidence Interval|Number
2590304|NCT02285777|Secondary|Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ LLQ at 4 Months After the 3-dose Vaccination Series|"The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ LLQ against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 4 months after the 3-dose vaccination series.~The LLQ cut off values for the strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6,8.9, 8 and 8.2 respectively."|At Month 10 (4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided informed consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 10 and whose immunogenicity assay result was available for at least one serogroup strain.|||Percentages of subjects||95% Confidence Interval|Number
2590305|NCT02285777|Secondary|Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at 1 Month After the 3-dose Vaccination Series.|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ LLQ against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 1 month after the 3-dose vaccination series.The LLQ cut off values for strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6, 8.9, 8 and 8.2 respectively.|At Month 7 (1 month after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Month 7)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 7 & whose immunogenicity assay result was available for at least one serogroup B test strain.|||Percentages of subjects||95% Confidence Interval|Number
2590306|NCT02285777|Secondary|HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs against four N. meningitidis serogroup B test strains (M14459, M07-0241084, 96217 and NZ98/254) after the 3-dose vaccination series.|At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Months 7 &10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.|||Titers||95% Confidence Interval|Geometric Mean
2590307|NCT02285777|Secondary|Percentages of Subjects With Enc-hSBA ≥ 1:4 and Enc-hSBA ≥1:8 at 1 and 4 Months After the 3-dose Vaccination Series|The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA ≥ 1:4 and enc-hSBA ≥ 1:8 against four N. meningitidis serogroup B test strains (M14459, M07-0241084, 96217 and NZ98/254) at 1 and 4 months after the 3-dose vaccination series (Month 7 and Month 10).|At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Immunogenicity (Months 7 &10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.|||Percentages of subjects||95% Confidence Interval|Number
2590308|NCT02285777|Secondary|Percentages of US N. Meningitidis Serogroup B Strains Killed at 1:4 and 1:8 Dilutions at 1 and 4 Months After the 3-dose Vaccination Series|The mean percentage of US N. meningitidis serogroup B strains killed by each subject, at 1:4 and 1:8 dilutions before the 3-dose vaccination series, at Month 6 (PRE) and at 1 and 4 months after the 3-dose vaccination series (Month 7 and Month 10).|At Month 6 (before the 3-dose vaccination series) and at Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Effectiveness (Months 6, 7 & 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, got subject ID & vaccination, & provided serum sample with enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain before Month 6 & at Months 7 & 10|||Percentage||Standard Deviation|Mean
2590400|NCT02284386|Primary|Maximum Plasma Concentration (Cmax)||Baseline through Day 14|Of 15 subjects, one subject was removed as an outlier|||ng/mL||Standard Deviation|Mean
2590310|NCT02285777|Secondary|Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the 3-dose Vaccination Series.|The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 4 months after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the hSBA against each strain in MenABCWY Group and MenACWY Group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.|At Month 10 (4 months after the 3-dose vaccination series)|Analysis was performed on FAS-Effectiveness (Month 10)- included all screened subjects who provided informed consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum sample with the enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain at Month 10|||Percentages of subjects|||Number
2590311|NCT02285777|Primary|Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitides (N. Meningitidis) Serogroup B Strain at 1 Month After the 3-dose Vaccination Series.|The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 month after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the human Serum Bactericidal Assay (hSBA) against each strain in MenABCWY group and MenACWY group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.|At Month 7 (1 month after the 3-dose vaccination series)|Analysis was performed on FAS-Effectiveness (Month 7)- included all screened subjects who provided informed consent & demographic &/or baseline screening assessments, received a subject ID & vaccination,& who provided evaluable serum sample with enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain at Month 7.|||Percentages of subjects|||Number
2590312|NCT02285634|Secondary|Change in Heart Rate|Change from baseline in heart rate.|baseline, 30 minutes||||beats/min||Standard Deviation|Mean
2590313|NCT02285634|Secondary|Change in Diastolic Blood Pressure|Change from baseline in diastolic blood pressure.|baseline, 30 minutes||||mmHg||Standard Deviation|Mean
2590314|NCT02285634|Secondary|Change in Systolic Blood Pressure|Change from baseline in systolic blood pressure.|baseline, 30 minutes||||mmHg||Standard Deviation|Mean
2590315|NCT02285634|Primary|Change in Mean Arterial Blood Pressure|Change in mean arterial blood pressure from the baseline measurement|baseline, 30 minutes||||mmHg||Standard Deviation|Mean
2590316|NCT02285270|Secondary|Change in Total Brown Adipose Tissue FDG Uptake as Measured by Total Volume of Segmented Fat Times the Mean Standardized Uptake Value (SUVmean)||~12-hours|No patients were analyzed since no patient showed uptake of FDG in brown adipose tissue.||||||
2590317|NCT02285270|Secondary|Correlation Between Cortisol Level and Brown Adipose Tissue FDG Uptake||~12-hours|No patients were analyzed since no patient showed uptake of FDG in brown adipose tissue.||||||
2590318|NCT02285270|Primary|Change in Maximum Standardized Update Value (SUVmax) in Brown Adipose Tissue FDG Uptake in the Neck or Upper Chest on Evening and Imaging Compared to Morning Imaging||~12-hours|No patients were analyzed since no patient showed uptake of FDG in brown adipose tissue.||||||
2590319|NCT02285153|Secondary|Bleeding Incidences|all bleeding incidence during the intensive care unit stay will be recorded. major bleeding criteria are taken from the Thrombolysis in myocardial infarction study (TIMI-Triton-38), potentially longer|average 28days||||counts|||Number
2590320|NCT02285153|Secondary|Number of Patients Who Developed a Thrombotic or Embolic Complications During the Trial|clinically relevant thromboembolic events assessed by standard care, potentially longer|average 28 days||||participants|||Number
2590321|NCT02285153|Secondary|Intensive Care Unit Mortality|Mortality of patients during their intensive care unit stay, 90 day mortality, potentially longer|up to 90 days after inclusion||||participants|||Number
2590322|NCT02285153|Primary|28-day Mortality|Standard outcome measure of investigational intensive care unit trials.|28-days|modified Intention to treat population (all patients who received at least a single dose of acetylsalicylic acid)|||participants|||Number
2590323|NCT02285062|Secondary|Mean Change From Baseline in the EQ-5D-3L Visual Analogue Scale (VAS)|"The EQ-5D-3L questionnaire includes a visual analogue scale which records the respondent's self-rated health on a vertical, 0-100 scale where 100 = Best imaginable health state and 0 = Worst imaginable health state. Higher scores again indicate better HRQoL and positive change scores indicate that post screening values were higher than those observed at screening. The EQ-5D-3L is a generic, self-reported preference-based measure of health across five dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has three levels of 'severity' corresponding to no problems, some problems and extreme problems."|Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34|The HRQoL evaluable population was defined as all participants in the ITT population who had: at least one baseline and the corresponding post-baseline calculable EQ-5D score assessment; where post-baseline is any subsequent time excluding unscheduled visits (i.e. at Midcycle, C6D1, EOT or a follow-up visit).|||Units on a Scale||Standard Deviation|Mean
2590324|NCT02285062|Secondary|Mean Change From Baseline in the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Index Score|"The EQ-5D-3L is a generic, self-reported preference-based measure of health across five dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has three levels of 'severity' corresponding to no problems, some problems and extreme problems. The instrument is scored as a single summary index using one of the available EQ-5D-3L value sets; in this study the UK scoring weights 9 were used. The UK index ranges from -0.594 to 1, where 0 equates to death and 1 equates to full health (-0.594 is considered 'worse than death')."|Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34|The HRQoL evaluable population was defined as all participants in the ITT population who had: at least one baseline and the corresponding post-baseline calculable EQ-5D score assessment; where post-baseline is any subsequent time excluding unscheduled visits (i.e. at Midcycle, C6D1, EOT or a follow-up visit).|||Units on a Scale||Standard Deviation|Mean
2605743|NCT02107014|Primary|Change in IL-27 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2590325|NCT02285062|Secondary|Mean Change From Baseline in the FACT-Lym Trial Outcome Index (TOI)|"The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from not at all (0) to very much (4). The FACT-Lym TOI is calculated by summing the Physical Well-being, Functional Well-being and Additional Concerns scores and has a range of 0 to 116. Higher scores reflect better HRQoL or fewer symptoms."|Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34|The HRQoL evaluable population was defined as all participants in the ITT population who had: at least one baseline and the corresponding post-baseline calculable FACT-Lym score assessment; where post-baseline is any subsequent time excluding unscheduled visits (i.e. at Midcycle, C6D1, EOT or a follow-up visit).|||Units on a Scale||Standard Deviation|Mean
2590326|NCT02285062|Secondary|Mean Change From Baseline in the FACT-Lym Functional Well-Being Subscale|"The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from not at all (0) to very much (4). The functional well-being subscale ranges from 0 to 28, where higher scores reflect better HRQoL."|Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34|The HRQoL evaluable population was defined as all participants in the ITT population who had: at least one baseline and the corresponding post-baseline calculable FACT-Lym score assessment; where post-baseline is any subsequent time excluding unscheduled visits (i.e. at Midcycle, C6D1, EOT or a follow-up visit).|||Units on a Scale||Standard Deviation|Mean
2590327|NCT02285062|Secondary|Mean Change From Baseline in the FACT-Lym Additional Concerns Subscale|"The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms such as pain, itching, night sweats,trouble sleeping, fatigue and trouble concentrating and concerns regarding lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment.~All questions are answered on a 5-point scale ranging from not at all (0) to very much (4). The Additional Concerns subscale ranges from 0 to 60, where higher scores reflect better HRQoL."|Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34|The HRQoL evaluable population was defined as all participants in the ITT population who had: at least one baseline and the corresponding post-baseline calculable FACT-Lym score assessment; where post-baseline is any subsequent time excluding unscheduled visits (i.e. at Midcycle, C6D1, EOT or a follow-up visit).|||Units on a Scale||Standard Deviation|Mean
2590328|NCT02285062|Secondary|Mean Change From Baseline in the FACT-Lym Physical Well-Being Subscale|"The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from not at all (0) to very much (4). The physical well-being subscale ranges from 0 to 28, where higher scores reflect better HRQoL."|Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34|The HRQoL evaluable population was defined as all participants in the ITT population who had: at least one baseline and the corresponding post-baseline calculable FACT-Lym score assessment; where post-baseline is any subsequent time excluding unscheduled visits (i.e. at Midcycle, C6D1, EOT or a follow-up visit).|||Units on a Scale||Standard Deviation|Mean
2590329|NCT02285062|Secondary|Percentage of Participants Who Completed the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Health Related Quality of Life (HR-QoL) Questionnaire|"The completion rate for EQ-5D assessments was judged by looking at the number of completed assessments at each time point. Completion rates were calculated as the number and percentage of participants out of the total number of patients in the ITT population and summarized by visit/cycle and treatment group. The EQ-5D-3L is a generic, self-reported preference-based measure of health across five dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has three levels of 'severity' corresponding to no problems, some problems and extreme problems. The instrument is scored using the United Kingdom (UK) index ranges from -0.594 - 1, where 0 equates to death and 1 equates to full health -0.594 is considered 'worse than death'."|Screening, Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34|The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.|||Percentage of Participants|||Number
2590336|NCT02285062|Secondary|K-M Estimate of Overall Survival (OS)|Overall survival was assessed by the IRAC and defined as time from randomization until death of any cause. Participants who withdrew consent were censored at the time of withdrawal. Participants who were still alive before the clinical data cutoff date and participants who were lost to follow-up were censored at date last known alive.|From the date of randomization up to the data cut off date of 15 March 2019; median follow-up was 24.5 months|The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.|||Months||95% Confidence Interval|Median
2590330|NCT02285062|Secondary|Percentage of Participants Who Completed the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Questionnaire|The completion rate for FACT-Lym assessments was judged by looking at the number of completed FACT-Lym assessments at each time point. The FACT-Lym was considered completed if at least 1 calculable score was present. Completion rates were calculated as the number and percentage of participants out of the total number of patients in the ITT population and summarized by visit/cycle and treatment group. The FACT-Lym is a health related quality of life (HRQoL) questionnaire targeted to the management of chronic illness, predominantly within oncology and is considered an extension of the FACT-General questionnaire.|Screening, Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34|The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.|||Percentage of Participants|||Number
2590331|NCT02285062|Secondary|Number of Participants With a Treatment Emergent Adverse Event (TEAE)|"A TEAE was defined as an AE that begins or worsens in intensity or frequency on or after the first dose of study drug through 28 days after last dose of study drug.~A serious adverse event (SAE) is any:~Death;~Life-threatening event;~Any inpatient hospitalization or prolongation of existing hospitalization;~Persistent or significant disability or incapacity;~Congenital anomaly or birth defect;~Any other important medical event The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death"|From the first dose of study treatment up to 28 days after the last dose of LEN/placebo or any component of R-CHOP including the optional 2 additional doses of rituximab if administered; up to 15 March 2019; maximum treatment duration = 29 months|The safety population was defined as all participants who had received at least one dose of investigational product.|||Participants|||Count of Participants
2590332|NCT02285062|Secondary|K-M Estimate of Time to Next Lymphoma Therapy (TTNLT)|Time to next lymphoma therapy was defined as the time from randomization to the time of treatment change for the next lymphoma treatment. Participants without treatment change were censored at date last known alive. Pre-specified optional therapies such as the extra 2 doses of single agent rituximab after Cycle 6 or consolidation radiotherapy did not count as treatment change for the next lymphoma therapy if the decision to treat and the location to be treated were determined prior to randomization.|From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months|The Intent-to-treat (ITT) population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.|||Months||95% Confidence Interval|Median
2590333|NCT02285062|Secondary|K-M Estimate of Duration of Complete Response|Duration of complete response was calculated for complete responders only and was defined as the time from documented initial complete response prior to initiation of subsequent systemic antilymphoma therapy until documented disease progression or death, whichever occurred earlier. Participants who had not progressed or died at the time of the analysis were censored at the date of last response assessment demonstrating no disease progression. Participants who changed treatment without evidence of disease progression were censored at the last assessment showing no progression prior to treatment change.|From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months.|The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. Participants who had a response.|||Months||95% Confidence Interval|Median
2590334|NCT02285062|Secondary|Percentage of Participants Who Achieved an Objective Response|An objective response = percentage of participants who achieved a complete response or partial response after initiation of the treatment and prior to initiation of subsequent systemic anti-lymphoma therapy. A CR = complete metabolic response; Target nodes/nodal masses regressed on computed tomography to (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy. Regressed to normal size by imaging, and absence of nodules related to lymphoma. If bone marrow was involved prior to therapy, no evidence of fluorodeoxyglucose avid disease in marrow. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in other nodes, liver, or spleen. Splenic nodules regressed by ≥ 50% in their SPD or for single nodules, in the greatest transverse diameter; no new lesions. Participants who did not have any adequate response assessments during this period were not considered as responders.|From randomization date up to the data cut off date of 15 March 2019; median total treatment duration was 18.10 weeks for both treatment arms; range = 1.6 to 29.0 weeks for R2-CHOP arm and 0.3 to 22.9 weeks for placebo-R-CHOP arm|The Intent-to-treat population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. Participants who had a PR or better.|||Percentage of Participants||95% Confidence Interval|Number
2590335|NCT02285062|Secondary|Percentage of Participants Who Achieved a Complete Response (CR)|The percentage of participants who achieved a CR after initiation of the study treatment and prior to initiation of subsequent systemic antilymphoma therapy as assessed by the IRAC. A CR = complete metabolic response; target nodes/nodal masses regressed on computed tomography to (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy. Regressed to normal size by imaging, and absence of nodules related to lymphoma. If bone marrow was involved prior to therapy, no evidence of fluorodeoxyglucose avid disease in marrow per International Working Group (IWG) 2014 for Non-Hodgkin's Lymphoma (NHL). Participants who did not have any adequate response assessments during this period were not considered as responders.|From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months|The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. Participants who had a CR.|||Percentage of Participants||95% Confidence Interval|Number
2590380|NCT02284516|Secondary|Change From Baseline in Patient-Reported Eye Dryness Score to Day 14 and Day 42|Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).|Baseline to Day 14 and Day 42|ITT population with LOCF. Here, n = number of participants analyzed for the specific categories of each arm, respectively.|||units on a scale||Standard Deviation|Mean
2590337|NCT02285062|Secondary|Kaplan-Meier (K-M) Estimate of Event Free Survival (EFS)|"EFS was defined as the time (months) from randomization until occurrence of one of the following events, whichever occurred first:~Disease progression~Initiation of subsequent systemic anti-lymphoma therapy~Death due to any cause The assessment of EFS was conducted by the IRAC using the International Working Group (IWG) criteria for NHL. Pre-specified optional therapies such as the extra 2 doses of single agent rituximab after Cycle 6 or consolidation radiotherapy did not count as an EFS event (initiation of subsequent systemic anti-lymphoma therapy) if the decision to treat and the location to be treated was determined prior to randomization. Participants who did not experience any of the events defined in the categories above before the clinical data cutoff date were censored at date last known alive."|From the date of randomization up to the data cut off date of 15 March 2019; median follow-up was 24.5 months|The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.|||Months||95% Confidence Interval|Median
2590338|NCT02285062|Primary|Kaplan-Meier Estimate of Progression Free Survival (PFS)|Progression free survival was defined as the time (months) from the date of randomization to the date of disease progression or death (any cause), whichever occurred earlier and was assessed by the Independent Response Adjudication Committee (IRAC). Relapse from complete response (CR) was considered as disease progression throughout the study. Disease progression was determined based on the Revised Response Criteria for Malignant Lymphoma. The PFS analysis was based on the censoring rules using the Food and Drug Administration (FDA) Guidance. Participants who did not experience disease progression and who did not die before the clinical data cutoff date were censored at the date of last adequate response assessment.|From the date of randomization up to the data cut off date of 15 March 2019; median follow-up of 24.5 months|The Intent-to-treat (ITT) population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.|||months||95% Confidence Interval|Median
2590339|NCT02285023|Secondary|Area Under the Curve for Thai CUQ2oL Scores in the Responder Group|"The receiver operating characteristic (ROC) analysis and area under the curve (AUC) are acceptable as the units of measure for assess the ability of a questionnaire to changes in patients' health-related quality of life (HRQoL) impairment over time that represents to responsiveness to change and minimal clinical important difference (MCID).~The AUC of the ROC analysis of 1, 0.9, 0.8, 0.7 and 0.5 were considered perfect, excellent, good, fair, and no better than chance, respectively."|baseline and 2 weeks|Responder group|||probability||95% Confidence Interval|Mean
2590340|NCT02285023|Secondary|Change in Thai CU-Q2oL Scores From Baseline for Responders and Non-Responders|- Investigate the smallest reduction in the Thai CU-Q2oL that patients recognized as a meaningful improvement.|baseline and 2 weeks||||score||Standard Deviation|Mean
2590341|NCT02285023|Secondary|Mean Total Score and Domain of Thai CU-Q2oL Scores From the Thai Version to Investigate Reliability of Thai-Version CU-Q2oL|"- The CU-Q2oL Questionnaire is a 23-item HRQoL questionnaire. It measures three dimensions (scales) of HRQoL: domain I (sleep, leisure, concentration), domain II (symptom, eating limits), and domain III (mental status, looks, impact on life activities) The scores of domain I of CUQ2oL range between 0 and 26. The scores of domain II of CUQ2oL range between 0 and 39.The scores of domain III of CUQ2oL between 0 and 35.~The minimum possible score is 0 and the maximum possible score is 100 for total scale.~-The DLQI scores range from 0-30. Domain I (leisure), Domain II (symptoms and feeling), and Domain III (daily activities, work, school, and personal relationships). Meaning of DLQI Scores: 0-1 = no effect, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, 21-30 = extremely large effect.~The higher the score, the more quality of life is impaired for both the CUQ2oL and the DLQI."|baseline|Mean score of domain I, II, III of Thai CU-Q2oL were correlated to mean score domain I, II, III of Thai DLQI, respectively|||units on a scale||Standard Deviation|Mean
2590342|NCT02285023|Primary|Cross-Cultural Validity of Thai-version CU-Q2oL|Cross-cultural validity is the degree to which the performance of the Thai CU-Q2oL items can adequately reflect the performance of the original CU-Q2oL items. Exploratory factor analysis was used to determine scales with proper item division of the Thai CU-Q2oL. Principal component analysis with varimax rotation was employed. An eigenvalue ≥ 1 was chosen as the criterion to retain domains. Each item was classified into the domain when loading with a domain loading ≥ 0.5.|4 week||||Percentage|||Number
2590343|NCT02285010|Secondary|Number of Patients Evaluating Their Satisfaction|Using four-point scale to evaluate patient satisfaction. Patients indicated if their satisfaction was Unsatisfied, Less Satisfied, Moderately Satisfied, or Good Satisfied.|24 hours||||Participants|||Count of Participants
2590344|NCT02285010|Secondary|Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability|Measure sedation score by evaluate and observe; measure pruritus, PONV, dizziness, visual disturbance using questionnaire|24 hours||||Participants|||Count of Participants
2590345|NCT02285010|Secondary|Pain Scores on the Visual Analog Scale|"Pain score is evaluated by nurses using Numerical Rating Scale (NRS)~Minimum score 0 (no pain), Maximum score 10 (worst imaginable pain), lower scores mean a better outcome"|24 hours||||score on a scale||Inter-Quartile Range|Median
2590346|NCT02285010|Secondary|Time to First Analgesia|Time to first analgesia is recorded from IV PCA.|24 hours|Only 47 and 53 participants from placebo and pregabalin group, respectively, received IV-PCA morphine in the 1st 24 hours. The rest didn't require morphine consumption.|||hour||Inter-Quartile Range|Median
2590347|NCT02285010|Primary|Post Operative Morphine Consumption|Cumulative morphine consumption in the first 24 hours is recorded from IV PCA|6, 12, and 24 hours after operation|Only 47 and 53 participants from placebo and pregabalin group, respectively, received IV-PCA morphine in the 1st 24 hours. The rest didn't require morphine consumption.|||mg||Inter-Quartile Range|Median
2590348|NCT02284906|Secondary|Time to Diagnosis of Alzheimer's Disease (AD) Dementia||Day 1 and every 6 months (up to maximum of 36 months)|As the study was early terminated, there were limited number of enrolled participants and insufficient treatment duration, therefore, data was not collected for this outcome measure.||||||
2590381|NCT02284516|Primary|Change From Baseline in Patient-Reported Eye Dryness Score to Day 84|Eye dryness score was scored on a Visual Analogue Scale (VAS) ranges from 0-100 (0=no discomfort; 100=maximal discomfort).|Baseline to Day 84|Intent to treat (ITT) population included all randomized participants who took at least 1 dose of investigational product with last observation carried forward (LOCF). Here, n = number of participants analyzed for the specific categories of each arm, respectively.|||units on a scale||Standard Deviation|Mean
2590349|NCT02284906|Primary|Change From Extension Study Baseline in Composite Score of a Broad Cognitive Test Battery at Month 24|Composite scores were derived from the test battery. Each test in the battery falls into 1 of the following cognitive domains: Episodic Memory (California Verbal Learning Test - 2nd Edition [CVLT-II], Brief Visuospatial Memory Test - Revised [BVMT-R]), Executive Function (Trail Making Part B, Digit Span Backwards), Language (Animals, Lexical/Phonemic Fluency), Attention (Digit Span Forward, Trail Making Part A), and Visuospatial (Clock Drawing, BVMT-Copy). Only the domains of episodic memory, executive function, language, and attention were used for the calculation of composite score (i.e., Clock Drawing, BVMT-Copy, and the Multilingual Naming Test (MINT), which do not allow generation of standard z scores, were only used for diagnostic purposes and were excluded from the calculation of the composite score). To form the composite, z-scores were calculated for each test, each z-score for the domain were averaged, and then all relevant domains were averaged to form the composite.|Baseline and Month 24|As the study was early terminated, there were limited number of enrolled participants and insufficient treatment duration, therefore, data was not collected for this outcome measure.||||||
2590350|NCT02284893|Secondary|Mean Change in Fasting Plasma Glucose (FPG)||Baseline (randomization) to Week 26|randomized subjects|||mg/dl||Standard Error|Mean
2590351|NCT02284893|Secondary|Mean Change in Total Body Weight||Baseline (randomization) to Week 26|randomized subjects|||kg||Standard Error|Mean
2590352|NCT02284893|Secondary|Percent of Subjects Achieving a Therapeutic Glycemic Response, Defined as HbA1c < 7.0%||week 26|randomized subjects|||Percentage of subjects|||Number
2590353|NCT02284893|Primary|Mean Change in HbA1c||Baseline (randomization) to Week 26|"The Randomized Subjects data set consists of all randomized subjects who received at least~1 dose of double-blind study drug during the double-blind treatment period. Data in this data set were analyzed based on randomized treatment group, even if the treatment they received was different"|||percentage (%)||Standard Error|Least Squares Mean
2590354|NCT02284880|Primary|AUC0-t - Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification|"Reference - MF - marketed formulation Test - TBM - to-be-marketed~BIA 2-005 - BIA 2-093 metabolite"|pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period||||ng.hr/ml||Standard Deviation|Mean
2590355|NCT02284880|Primary|Tmax - Time of Occurrence of Cmax|"Reference - MF - marketed formulation Test - TBM - to-be-marketed~BIA 2-005 - BIA 2-093 metabolite"|pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period||||hours||Full Range|Median
2590356|NCT02284880|Primary|Cmax - Maximum Plasma Concentration|Reference - MF - marketed formulation Test - TBM - to-be-marketed BIA 2-005 - BIA 2-093 metabolite|pre-dose then 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose on each dosing period||||ng/ml||Standard Deviation|Mean
2590357|NCT02284867|Secondary|Comparison of CD16+ CD56 Dim Uterine Natural Killer Cells (uNK) Prevalence in Decidua vs. Villi in Placenta of Both Study Groups|CD16+ CD56dim uterine Natural Killer cells (uNK) in the villi was found in Preterm delivery Group.|2 years||||participants|||Number
2590358|NCT02284867|Primary|Uterine Natural Killer Cells In Preterm Labor|Number of participants with CD16 orCD 56 uterine Natural Killer Cells positive staining of placental sample|2 years||||participants|||Number
2590359|NCT02284854|Primary|AUC0-t (CBZE) - Area Under the Curve to Last Measurable Concentration for CBZE|"Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg~CBZE - carbamazepine-epoxide is the active metabolite of CBZ"|Day 28 to 35||||ng*h/mL||Standard Deviation|Mean
2590360|NCT02284854|Primary|AUC0-t (CBZ) - Area Under the Curve to Last Measurable Concentration for CBZ|Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg|Day 28 to 35||||ng*h/mL||Standard Deviation|Mean
2590361|NCT02284854|Primary|AUC0-t (BIA 2-093) - Area Under the Curve to Last Measurable Concentration for BIA 2-093|Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg|Day 7 to 35||||ng*h/mL||Standard Deviation|Mean
2590362|NCT02284854|Primary|Cmax (CBZE) - the Maximum Plasma Concentration|"Reference - Day 28 following twice-daily oral administration of CBZ 400 mg twice-daily Test - Day 35 following twice-daily oral administration of CBZ 400 mg twice-daily~CBZE - carbamazepine-epoxide is the active metabolite of CBZ"|Day 28 to 35||||ng/mL||Standard Deviation|Mean
2590363|NCT02284854|Primary|Cmax (CBZ) - the Maximum Plasma Concentration|Reference - Day 28 following twice-daily oral administration of CBZ 400 mg Test - Day 35 following twice-daily oral administration of CBZ 400 mg|Day 28 to 35||||ng/mL||Standard Deviation|Mean
2590364|NCT02284854|Primary|Cmax (BIA 2-093) - the Maximum Plasma Concentration|Reference - Day 7 following once-daily oral administration of ESL 800 mg Test - Day 35 following once-daily oral administration of ESL 800 mg|Day 7 to 35||||ng/mL||Standard Deviation|Mean
2590365|NCT02284828|Primary|Total Reaction Time (TRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose||||miliseconds||Standard Deviation|Mean
2590366|NCT02284828|Primary|Total Reaction Time (TRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose||||miliseconds||Standard Deviation|Mean
2590367|NCT02284828|Primary|Recognition Reaction Time (RRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose||||miliseconds||Standard Deviation|Mean
2590368|NCT02284828|Primary|Recognition Reaction Time (RRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose||||miliseconds||Standard Deviation|Mean
2590369|NCT02284828|Primary|Motor Reaction Time (MRT) (ms): Raw Values at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose||||miliseconds||Standard Deviation|Mean
2590370|NCT02284828|Primary|Motor Reaction Time (MRT) (ms): Change From Baseline at Each Time Point During Acute Dosing Phase||-1, 3, 6, and 10 hours post-dose||||miliseconds||Standard Deviation|Mean
2590382|NCT02284464|Secondary|Renal Function|Renal function after kidney transplant in both groups at 24 months measured according to the proteinuria (mg/24 h) concentrations|24 months||||mg/24h||Standard Deviation|Mean
2590383|NCT02284464|Secondary|Graft Survival|Graft survival after kidney transplant in both groups|24 months||||Participants|||Count of Participants
2590371|NCT02284568|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents usual activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 up to Week 130 (longest duration of treatment)|Safety population|||Participants|||Count of Participants
2590372|NCT02284568|Secondary|Number of New T2 Brain Lesions at Week 48|Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new T2 lesions at week 48 as compared to baseline. Scans of patients who discontinued the study after week 36 are considered scans at week 48, and are included in week 48.|Baseline (Week 0), 48 weeks|Modified intent to treat 1 (mITT1) population includes participants with at least 1 post-baseline PBVC value. Participants from the mITT1 with MRI data at week 48 are reported .|||lesions||Standard Deviation|Mean
2590373|NCT02284568|Secondary|Change From Baseline for the Timed 25-foot Walk (T25FW) Score at Weeks 12, 24, 36 and 48|The T25FW is a quantitative mobility and leg function performance test based on the average time of two trials in which participants walk 25 feet as quickly as possible. In cases when a patient could not complete a T25FW trial due to the physical limitations, a value of 180 seconds was assigned for that trial (this is the maximal possible value for the T25FW test). Increasing time scores indicate increasing impairment. Baseline values are summaries of observed values. Week values are change from baseline values.|Baseline (Week 0), Weeks 12, 24, 36, 48|Modified Intent to Treat #2 (mITT2) population is a subset of the ITT population. It includes all participants in the ITT population with at least 1 post baseline efficacy assessment other than PBVC.|||seconds||Full Range|Median
2590374|NCT02284568|Secondary|Percentage of Participants With 12-Week Confirmed Disability Progression (CDP) As Measured by Expanded Disability Status Scale (EDSS) or the Timed 25-foot Walk (T25FW) Test up to Week 48|"CDP was defined as~increase in EDSS of >=1 point from baseline EDSS, if EDSS at entry is ≤5.0 or increase of >=0.5 point, if EDSS at entry is >=5.5 confirmed after at least 12 weeks, OR increase of >= 20% from baseline in the T25FW test, confirmed after at least 12 weeks.~EDSS quantifies disability in MS and monitors changes in the level of disability over time. The EDSS scale is 0-10 in 0.5 unit increments with 0=no disability and 10=death due to MS. The T25-FW is a quantitative mobility and leg function performance test based on the average time of two trials in which participants walk 25 feet as quickly as possible. Increasing time scores indicate increasing impairment.~If a patient died due to MS disease progression, the patient was analyzed as having CDP with the time to CDP as the onset date of progression. If a patient died due to MS before having progression, then the time to disability progression was censored using the date of death."|Baseline (Week 0), Weeks 12, 24, 36, 48 (end if treatment if < 48 weeks)|ITT population|||percentage of participants|||Number
2590375|NCT02284568|Secondary|Percentage of Participants With 12-Week Confirmed Disability Progression (CDP) As Measured by Expanded Disability Status Scale (EDSS) up to Week 48|CDP was defined as increase in EDSS of >=1 point from baseline EDSS, if EDSS at entry is ≤5.0 or increase of >=0.5 point, if EDSS at entry is >=5.5. This increase should be confirmed after at least 12 weeks. Progression cannot be confirmed during a protocol defined relapse. EDSS is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The EDSS scale ranges from 0 to 10 in 0.5 unit increments with 0=no disability and 10=death due to MS. Only an Examining Neurologist administered the EDSS. The Examining Neurologist did not have access to the patient's medical records or source documents, including previous EDSS forms or adverse events. If a patient died due to MS disease progression, the patient was analyzed as having CDP with the time to CDP as the onset date of progression. If a patient died due to MS before having progression, then the time to disability progression was censored using the date of death.|Baseline (Week 0), Weeks 12, 24, 36, 48 (end if treatment if < 48 weeks)|ITT population|||percentage of participants|||Number
2590376|NCT02284568|Primary|Percent Brain Volume Change (PBVC) From Baseline to Weeks 24 and 48|Brain atrophy (BA) was measured using magnetic resonance imaging (MRI) scans of the brain. Early termination scans of participants who discontinued the study after week 36 are considered scans at week 48.|Baseline (at least 14 days but not more than 6 weeks prior to Day 1), Weeks 24, 48|Modified Intent to Treat 1 (mITT1) population with at least 1 post-baseline PBVC value.|||percentage change from baseline||Standard Deviation|Mean
2590377|NCT02284568|Primary|Percent Brain Volume Change (PBVC) From Baseline to Week 48 Using a Repeated Measures ANCOVA Model|Brain atrophy (BA) was measured using magnetic resonance imaging (MRI) scans of the brain. BA was analyzed using baseline-adjusted repeated measures analysis of covariance (ANCOVA- SAS® PROC MIXED) in which 1 contrast was constructed in order to compare between laquinimod 0.6 mg and placebo. The statistical model was a repeated measures analysis of covariance with treatment group, week, treatment group by week interaction, normalized brain volume at baseline, natural logarithm of T2 lesion volume at baseline, and country as fixed effects. Only on-treatment observations (include all the assessments done up to one month after the last dose of the study drug) were included. Values are adjusted means. The cancelled laquinimod 1.5 mg treatment arm was not included in the repeated measures ANCOVA model analysis. However PBVC by visit data are offered in outcome #2.|Baseline (at least 14 days but not more than 6 weeks prior to Day 1), Weeks 24, 48 and including early termination visits|Modified Intent to Treat 1 (mITT1) population with at least 1 post-baseline PBVC value and will include assessments taken up to/including early termination/study completion visit.|||percentage change from baseline||Standard Error|Mean
2590378|NCT02284555|Secondary|The Number of Subjects With Adverse Events and Changes in Vital Signs, ECG and Routine Haematology, Clinical Chemistry and Urinalysis Tests Assessed Over the Five Day Treatment Period and Follow-up at 7 and 14 Days Relative to the First Dose.||5 day treatment period and follow-up at 7 and 14 days||||participants|||Number
2590379|NCT02284555|Primary|Apparent Eradication of Nasal Carriage of SA|Apparent eradication demonstrated by a semi-quantitative score of negative or zero using a broth enriched culture microbial assay.|48 hours after the last dose of mupirocin 2%||||participants|||Number
2590384|NCT02284464|Secondary|Patient Survival|Patient survival after kidney transplant in both groups|24 months||||Participants|||Count of Participants
2590403|NCT02284347|Primary|Device-related Adverse Event Point Estimate|The primary safety endpoint was the point estimate (and confidence interval) for all AEs that were directly attributable to the device or for which the cause could not be determined and that met the definition of designated primary safety endpoint AEs as defined in the protocol.|2 weeks|Participants|||Adverse Events||95% Confidence Interval|Number
2590404|NCT02284347|Primary|Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium|Two-fold endpoint: Investigator-assessment regarding the number of sinuses that were easily navigated to the desired treatment location and easy dilation of the ostium|At time of surgery|All patients that completed the study|||Number of sinuses|||Number
2590405|NCT02284243|Secondary|Number of Subjects With Complete Protection From PONV||24 hours|mITT population, including all randomized subjects who received at least one study dose|||participants|||Number
2590406|NCT02284243|Secondary|Time to First Rescue Medication Use|Kaplan Meier analysis of time to first use of rescue analgesia 50th percentile of subjects. Rescue analgesia (oral oxycodone) was available to subjects with inadequately controlled pain. All doses of rescue analgesia administered were recorded and the time from the first study dose to first rescue analgesia in each subject was evaluated. A longer time to first rescue is better.|48 hours|mITT population, including all randomized subjects who received at least one study dose|||hours||95% Confidence Interval|Median
2590407|NCT02284243|Secondary|Use of Rescue Medication (Oral Opioids)|Number of subjects requiring rescue medication (Oral opioids) within 48 hours after first study dose|48 hours|mITT population, including all randomized subjects who received at least one study dose|||participants|||Number
2590408|NCT02284243|Secondary|Number of Subjects With Significant Pain Improvement Following the First Study Dose.||6 hours|mITT population, including all randomized subjects who received at least one study dose|||participants|||Number
2590409|NCT02284243|Secondary|Time to Perceptible and Meaningful Pain Relief|Kaplan-Meier analysis of time to perceptible and meaningful pain relief for 50th percentile of subjects. Time to perceptible pain relief and time to meaningful pain relief were measured using the double-stopwatch method. The first stopwatch was given to each subject with the instructions to stop the watch when they first perceive pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they are first experiencing meaningful pain relief (time to meaningful relief). A shorter time to pain relief is better.|6 hours|mITT population, including all randomized subjects who received at least one study dose|||minutes||95% Confidence Interval|Median
2590410|NCT02284243|Secondary|SPID at Various Other Time Points|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline were calculated at each time point and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation.|Up to 48 Hours|mITT population, including all randomized subjects who received at least one study dose|||units on a scale||Standard Deviation|Mean
2590411|NCT02284243|Primary|Summed Pain Intensity Difference Over the First 48 Hours (SPID48).|Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline were calculated at each time point and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation.|48 hours|mITT population, including all randomized subjects who received at least one study dose|||units on a scale||Standard Deviation|Mean
2590412|NCT02284178|Post-Hoc|Clinical Outcome: Hospital Length of Stay||Duration of Hospital Stay||||Days||Standard Deviation|Mean
2590413|NCT02284178|Post-Hoc|Clinical Outcome: Intensive Care Unit Length of Stay||Duration of Intensive Care Unit Stay||||Days||Standard Deviation|Mean
2590414|NCT02284178|Post-Hoc|Clinical Outcome: Ventilator Hours||Duration of Mechanical Ventilation||||Hours||Standard Deviation|Mean
2590415|NCT02284178|Other Pre-specified|Tracheal to Oral Ratio of Amylase|The ratio of the tracheal value to the oral value of amylase for each paired sample was calculated (ratio included baseline specimen collected).|Every 12 hours up to 14 days||||Ratio of tracheal amylase to oral value||Standard Deviation|Mean
2590416|NCT02284178|Secondary|Time to VAC||VAC was assessed for two days beyond the last intervention; mean 5.4 days||||Days||Standard Deviation|Mean
2590417|NCT02284178|Secondary|Ventilator-Associated Condition (VAC) Rate|VAC rate was calculated between control and intervention groups using the Centers for Disease Control and Prevention (2013) criteria.|VAC assessed for 2 days beyond last intervention; mean 5.4 days||||Participants|||Count of Participants
2590418|NCT02284178|Primary|Microaspiration as Measured by Percentage of Tracheal Specimens Positive for Amylase Per Participant|Specimens will be obtained every 12 hours for up to 14 days or subject no longer meets inclusion criteria|Every 12 hours up to 14 days||||percentage specimens positive amylase|||Number
2590419|NCT02284178|Primary|Microaspiration as Measured by Tracheal Amylase|Specimens will be obtained every 12 hours for up to 14 days or subject no longer meets inclusion (e.g., extubation, tracheostomy, etc.); tracheal amylase measured in U/L.|Every 12 hours up to 14 days||||U/L||Standard Deviation|Mean
2590420|NCT02284165|Secondary|Number of Participants Who Died Within 12 Months of Stroke Hospitalization|Death within 12 months of discharge from index stroke hospitalization as indicated in Medicare claims files|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, discharged to inpatient rehabilitation or skilled nursing facility and without survival limitations identified in-hospital. 69,212 patients met these criteria.|||participants|||Number
2603256|NCT02134119|Secondary|Hematological Measures - Ferritin|as measured by ferritin at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)||||ng/mL||Standard Deviation|Mean
2590421|NCT02284165|Secondary|Number of Participants Who Were Rehospitalized or Died Within 12 Months of Stroke Hospitalization.|All-cause rehospitalization or death within 12 months of index stroke hospitalization as indicated in Medicare claims files.|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, discharged to inpatient rehabilitation or skilled nursing facility and without survival limitations identified in-hospital. 69,212 patients met these criteria.|||participants|||Number
2590422|NCT02284165|Secondary|Number of Participants Who Were Institutionalized in a Nursing Home for Long-term Care Within 12 Months of Hospital Discharge.|Institutionalization (primary living location in a nursing home for long-term care and not for rehabilitation or short-term skilled stay) as measured by patient or proxy family member report on 12-month follow-up phone call.|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry discharged to inpatient rehabilitation or skilled nursing facility, without survival limitations identified in-hospital and with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry. 473 patients met these criteria.|||participants|||Number
2590423|NCT02284165|Secondary|Quality of Life (QOL)|EuroQOL-5 Dimensions (EQ-5D) to assess health-related quality of life by asking and scoring the level of severity (1 = no problems, 2 = some problems, 3 = extreme problems) in 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Score for each question is added together to provide total score, which is converted to provide a range from 1 (maximum and highest health state for quality of life) down to 0 (lowest health state and quality of life).|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry discharged to inpatient rehabilitation or skilled nursing facility, without survival limitations identified in-hospital and with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry. 323 patients met these criteria.|||units on a scale||Inter-Quartile Range|Median
2590424|NCT02284165|Secondary|Number of Participants Who Were Functionally Dependent or Dead 12 Months After Hospital Discharge|12-month functional status as measured by modified Rankin scale scores ranging between 0 (no symptoms) and 6 (death), among patients discharged to inpatient rehabilitation or skilled nursing facility. Outcome measure reports number of participants with Rankin score of 3-6. The outcome was not assessed among patients discharged home.|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry discharged to inpatient rehabilitation or skilled nursing facility, without survival limitations identified in-hospital and with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry. 473 participants met these criteria.|||participants|||Number
2590425|NCT02284165|Primary|Home-time|Number of days alive and living outside of inpatient care|12 months post-discharge|Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, discharged to inpatient rehab or skilled nursing care and without survival limitations identified in-hospital. 69,212 patients met these criteria.|||days||Standard Deviation|Mean
2590426|NCT02284165|Primary|Number of Participants Receiving Inpatient, Home, or Community Based Rehabilitation Services|Received either inpatient care in an inpatient rehabilitation or skilled nursing facility, or home or community-based rehabilitation.|discharge through 90 days|Acute ischemic stroke patients in the Get With the Guidelines registry with Medicare fee-for-service health insurance, analyzed as one cohort rather than by arm to differentiate the different types of rehabilitation services within the full patient population.|||participants|||Number
2590427|NCT02284009|Secondary|Population Estimates of PK Parameters: First-order Absorption Rate Constant [Ka]|PK of Albiglutide was evaluated in participants using Ka using PK samples collected on Weeks 4, 6, 8, 16. Ka was evaluated by population PK methods and mean and standard error from the final model has been tabulated. Estimates have been presented from the final model centered to mean bodyweights of 67 kilograms, and eGFR of 123 milliliters per minute.|48 hours after the most recent dose at Week 4, 6, 8 and 16|PK population|||Per hour||Standard Error|Mean
2590428|NCT02284009|Secondary|Population Estimates of PK Parameters: Apparent Volume of Distribution [V/F]|PK of Albiglutide was evaluated in participants using V/F using PK samples collected on Weeks 4, 6, 8, 16. V/F was evaluated by population PK methods and mean and standard error from the final model has been tabulated. Estimates have been presented from the final model centered to mean body weights of 67 kilograms, and eGFR of 123 milliliters per minute.|48 hours after the most recent dose at Week 4, 6, 8 and 16|PK population|||Milliliters||Standard Error|Mean
2590429|NCT02284009|Secondary|Population Estimates of Pharmacokinetic (PK) Parameters: Apparent Clearance [CL/F]|PK of Albiglutide was evaluated in participants using CL/F using PK samples collected on Weeks 4, 6, 8, 16. CL/F was evaluated by population PK methods and mean and standard error from the final model has been tabulated. Estimates have been presented from the final model centered to mean body weights of 67 kilograms, and electronic glomerular filtration rate (eGFR) of 123 milliliters per minute.|48 hours after the most recent dose at Week 4, 6, 8 and 16|PK population which comprised of participants in 'Safety Population' for whom a pharmacokinetic sample was obtained and analyzed. Only participants who received albiglutide were included in PK Population.|||Milliliters per hour||Standard Error|Mean
2590430|NCT02284009|Secondary|Weight Over Time (at Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64)|Body weight was measured in kilograms for participants at indicated time points.|Weeks 2, 4, 6, 8, 16, 28, 40, 52 and 64|ITT Population. Only participants with available data at the specified time points were summarized|||kilograms||Standard Deviation|Mean
2590431|NCT02284009|Secondary|Change From Baseline in Body Weight (Kilograms) at Week 52|Change from Baseline in body weight of participants was reported. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication. Change from Baseline was calculated by subtracting the Baseline value from the Week 52 value.|Baseline and Week 52|ITT Population. Only those participants with available data at the specified time points were analyzed.|||Kilograms||Standard Deviation|Mean
2590440|NCT02284009|Secondary|Change From Baseline in Percent HbA1c at Week 52|Change from Baseline in percent HbA1c was reported. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication. Change from Baseline was calculated by subtracting Baseline value from the Week 52 value.|Baseline and Week 52|ITT Population. Only those participants with available data at the specified time points were analyzed.|||Percentage of HbA1c||Standard Deviation|Mean
2590432|NCT02284009|Secondary|Greatest Magnitude of Hyperglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52|A hyperglycemic excursion is defined as an occurrence where the plasma glucose level > 10.0 mmol/L (> 180 mg/dL). At each visit, only evaluable participants, defined as those with >= 4 non-missing glucose values or >= 1 hyperglycemic excursions were included. Greatest hyperglycemic excursion was calculated as the largest recorded glucose level during the 7-point glucose profile (before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, at bedtime) minus 10.0 mmol/L. If a participant had data recorded at that visit, but does not have a value > 10.0 mmol/L, their greatest hyperglycemic excursion would be 0 mmol/L for that visit. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication.|Baseline and weeks 28 and 52|ITT Population. Only evaluable participants, as defined in the Measure Description were analysed (represented by n=X in the category titles).|||mmol/L||Standard Deviation|Mean
2590433|NCT02284009|Secondary|Number of Hyperglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52|A hyperglycemic excursion is defined as an occurrence where the plasma glucose level > 10.0 mmol/L (> 180 mg/dL). At each visit, only evaluable participants, defined as those with >= 4 non-missing glucose values or >= 1 hyperglycemic excursions were included. Number of Hyperglycemic Excursions for each participant from 7-Point Glucose Profile (Before breakfast, 2 hours after breakfast, Before lunch, 2 hours after lunch, Before dinner, 2 hours after dinner, At bedtime) were reported. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication.|Baseline and Weeks 28 and 52|ITT Population. Only evaluable participants, as defined in the Measure Description were analysed (represented by n=X in the category titles).|||Hyperglycemic excursions||Standard Deviation|Mean
2590434|NCT02284009|Secondary|Greatest Magnitude of Hypoglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52|A hypoglycemic excursion was defined as an occurrence where the plasma glucose level <=3.9 mmol/L (<= 70 mg/dL). At each visit, only evaluable participants, defined as those with >= 4 non-missing glucose values or >= 1 hypoglycemic excursions were included. Greatest hypoglycemic excursion was calculated as 3.9 mmol/L minus the lowest recorded glucose level during the 7-point glucose profile (Before breakfast, 2 hours after breakfast, Before lunch, 2 hours after lunch, Before dinner, 2 hours after dinner, At bedtime). If a participant had data recorded at that visit, but did not have a value <= 3.9 mmol/L, their greatest hypoglycemic excursion were 0 mmol/L for that visit. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication.|Baseline and Weeks 28 and 52|ITT Population. Only evaluable participants, as defined in the Measure Description were analysed (represented by n=X in the category titles).|||mmol/L||Standard Deviation|Mean
2590435|NCT02284009|Secondary|Number of Hypoglycemic Excursions for Each Participant From 7-Point Glucose Profile at Baseline, Week 28 and 52|A hypoglycemic excursion was defined as an occurrence where the plasma glucose level <=3.9 mmol/L (<=70 mg/dL). At each visit, only evaluable participants, defined as those with >= 4 non-missing glucose values or >= 1 hypoglycemic excursions were included. Number of Hypoglycemic Excursions for each participant from 7-Point Glucose Profile (Before breakfast, 2 hours after breakfast, Before lunch, 2 hours after lunch, Before dinner, 2 hours after dinner, At bedtime) were reported. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication.|Baseline and Weeks 28 and 52|ITT Population. Only evaluable participants, as defined in the Measure Description were analysed (represented by n=X in the category titles).|||Hypoglycemic excursions||Standard Deviation|Mean
2590436|NCT02284009|Secondary|Time Spent With Plasma Glucose Level <= 3.9, > 3.9 to <= 10.0, and > 10.0 Measured by 72 Hour Continuous Glucose Monitoring (CGM) at Baseline, Week 28 and 52|Three days before the visit, the participants made an additional visit to the study site to have the CGM fitted/inserted. It was worn for 3 consecutive days and was removed at the scheduled study visit. Whilst wearing the CGM, participants continued to monitor their plasma glucose at least 4 times a day and on one of the days, conducted 7-point glucose profile (Before breakfast, 2 hours after breakfast, Before lunch, 2 hours after lunch, Before dinner, 2 hours after dinner, At bedtime). Time spent with a plasma glucose <=3.9 millimoles per liter (mmol/L), between >3.9 and 10.0 mmol/L, and >10.0 mmol/L, respectively as performed by 72-hour CGM at Baseline, Week 28 and Week 52 was reported.|Baseline and Weeks 28 and 52|ITT Population. Only those participants with available data at the specified time points were analysed (represented by n=X in the category titles).|||hours per day||Standard Deviation|Mean
2590437|NCT02284009|Secondary|Number of Events of Participant-reported Significant Hypoglycemia, Occurring > Week 24 and <= Week 52|Significant hypoglycemia was defined as an event with plasma glucose level <= 3.9 mmol/L (<= 70 mg/dL) and/or requiring third party intervention. This corresponds to American Diabetes Association (ADA) category definitions of severe, documented symptomatic, and asymptomatic hypoglycemia. The time period was defined as: > Week 24 to <= Week 52 = Day 169 to Day 364. Number of Events were defined as the total number of significant hypoglycemic events at each level of summarization. Number of events of hypoglycemia with confirmed self plasma glucose monitoring <=3.9 mmol/L and/or requiring third party intervention (i.e., severe, documented symptomatic and asymptomatic hypoglycemic events) occurring >Week 24 and <=Week 52 are presented.|Week 24 to 52|ITT Population. Only those participants with available data at specified time points were analyzed|||Hypoglycemic events|||Number
2590438|NCT02284009|Secondary|Change From Baseline in Mean Daily Insulin Use at Week 4, 8, 16, 28, 40, 52 and 64|The mean daily insulin use value was calculated, in units/kg/day as the sum of average prandial insulin doses and average of basal insulin doses for each participant recorded daily for the 3 days prior to the specified visits, divided by the participant's body weight in kg. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 4, 8, 16, 28, 40, 52 and 64|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Units/kg/day||Standard Deviation|Mean
2590439|NCT02284009|Secondary|Percent HbA1c Over Time (at Weeks 4, 8, 16, 28, 40, 52 and 64)|Blood samples were collected from participants for analysis of HbA1c at indicated time points and percentage of HbA1c has been calculated for Weeks 4, 8, 16, 28, 40, 52 and 64.|Weeks 4, 8, 16, 28, 40, 52 and 64|ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n=x in the category titles).|||Percentage of HbA1c||Standard Deviation|Mean
2590441|NCT02284009|Secondary|Percentage of Participants Achieving Partial Remission Status (Insulin Dose-adjusted Hemoglobin A1c (IDAA1C)<= 9.0) at Baseline, Week 4, 8, 16, 28, 40, 52 and 64|Participant achieving partial remission status was defined as a participant with IDAA1C <=9.0 . Percentages were based on the number of participants with available IDAA1c data in each treatment group at that visit.|Baseline and Weeks 4, 8, 16, 28, 40, 52 and 64|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percentage of participants|||Number
2590442|NCT02284009|Secondary|Percentage of Responders at Baseline, Weeks 4, 8, 16, 28, 40, 52 and 64|Responders were defined as participants achieving glycosylated hemoglobin A1c (HbA1c) <= 7.0 percent and mean daily insulin use < 0.5 units per kilograms (kg) per day. Percentages are based on the number of participants with available HbA1c and insulin use data in each treatment group at that visit.|Baseline and Weeks 4, 8, 16, 28, 40, 52 and 64|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percentage of participants|||Number
2590443|NCT02284009|Secondary|Mean Change From Baseline in Time Normalized Plasma Glucagon AUC (From MMTT) at Week 16, 28, 52 and 64|Blood samples were taken to assess levels of glucagon at: 10 minutes before Time 0 (-10 minutes), immediately before the participant started drinking the nutritional drink (Time 0) and 15, 30, 60, 90, and 120 minutes after Time 0. Mean change from Baseline in time normalized plasma glucagon AUC (from MMTT) at Week 16, 28, 52 and 64 was reported. Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 16, 28, 52 and 64|ITT Population. Only parts with data available at specified data points were analyzed (represented by n= X in the category titles). Time normalized plasma glucagon AUC was calculated using trapezoidal rule then dividing by 120 (if result at t=120 is non-missing otherwise time difference between first and last times with non-missing results is used)|||Nanograms per liter||Standard Deviation|Mean
2590444|NCT02284009|Secondary|Maximum Stimulated Plasma C-peptide (MMTT) at Baseline, Week 16, 28, 52 and 64|Maximum stimulated plasma C-peptide was the highest value at any time point during the 2 hour MMTT after the participant has ingested the mixed meal at Baseline, Week 16, Week 28, Week 52 and Week 64. Blood samples were taken to assess levels of C-peptide at: 10 minutes before Time 0 (-10 minutes), Immediately before the participant starts drinking the nutritional drink (Time 0) and 15, 30, 60, 90, and 120 minutes after Time 0.|Baseline and Weeks 16, 28, 52 and 64|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Nanomoles per liter||Standard Deviation|Mean
2590445|NCT02284009|Secondary|Mean Change From Baseline in Time Normalized Stimulated (From MMTT) 2 Hour Plasma C-peptide AUC at Week 16, 28 and Week 64|Participants had a balanced diet consistent with dietitian's advice and made no major changes in exercise regimens. On the evening before the MMTT, participants had a full meal and then fasted from 9 pm until the MMTT was completed. Water, black coffee or tea without sugar or artificial sweeteners was allowed. Plasma glucose was measured prior to the test using a finger-stick test and MMTT was performed only if it was in range > 3.9 mmol/L (70 mg/dL) and <= 11.1 mmol/L (200 mg/dL). Baseline was defined as the last non-missing value with an assessment date on or before the first day of study medication. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Weeks 16, 28 and 64|ITT Population. Only parts with data available at specified data points were analyzed (represented by n= X in the category titles).Time normalized plasma C-peptide AUC was calculated using trapezoidal rule then dividing by 120 (if result at t=120 is non-missing otherwise time difference between first and last times with non-missing results is used)|||Nanomoles per liter||Standard Deviation|Mean
2590446|NCT02284009|Primary|Mean Change From Baseline in Time Normalized Stimulated (From Mixed Meal Tolerance Test [MMTT]) 2-hour Plasma C-peptide Area Under the Curve (AUC) at Week 52|Participants (parts) had a balanced diet consistent with dietitian's advice and made no major changes in exercise regimens. Evening before the MMTT, participants had a full meal then fasted from 9 post meridiem (pm) until MMTT was completed. Water, black coffee or tea without sugar or artificial sweeteners was allowed. Plasma glucose was measured prior to the finger-stick test and MMTT was performed only if in range > 3.9 millimoles per liter (mmol/L) [70 mg/deciliter (dL)] and <= 11.1 mmol/L (200 mg/dL). Baseline was defined as the last non-missing value with assessment date on or before the 1st day of study medication. Change from Baseline was calculated by subtracting Baseline value from Week 52 value. Intent-to-treat (ITT) Population comprised of all randomly assigned participants who received at least 1 dose of study medication with at least 1 post-Baseline assessment of the primary endpoint.|Baseline and Week 52|ITT Population. Only those participants with available data at the specified time points were analyzed. Time normalized plasma C-peptide AUC was calculated using trapezoidal rule then dividing by 120 (if the result at t=120 is non-missing otherwise the time difference between first and last times with non-missing results is used)|||Nanomoles per liter||Standard Deviation|Mean
2590447|NCT02283840|Primary|Tmax BIA 2-005 - Time of Maximum Plasma Concentration of BIA 2-005||prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration||||hours||Standard Deviation|Median
2590448|NCT02283840|Primary|AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time||prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration||||ng.h/mL||Standard Deviation|Mean
2590449|NCT02283840|Primary|Cmax BIA 2-005 - the Maximum Plasma Concentration of BIA 2-005||prior to and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 24, 48 and 72 hours after drug administration||||ng/mL||Standard Deviation|Mean
2590450|NCT02283827|Secondary|Tmax - the Time of Occurrence of Cmax|BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate|Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration||||hours||Standard Deviation|Median
2590451|NCT02283827|Secondary|AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time|"AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time~BIA 2-194 and BIA 2-195 are metabolites of eslicarbazepine acetate"|Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration||||ng*h/mL||Standard Deviation|Mean
2605744|NCT02107014|Primary|Change in IL-31 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2590453|NCT02283814|Secondary|AUCτ - Cumulative Area Under the Plasma Concentration Time Curve Over the Dosing Interval at Steady State.||Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h||||ng.h/mL||Standard Deviation|Mean
2590454|NCT02283814|Primary|Tmax - the Time of Occurrence of Cmax|BIA 2-194 and BIA 2-195 are metabolites/active forms of eslicarbazepine acetate Both Groups A and B described in participant flow recieved BIA 2-093 and Topiramate. The results presented here are related with the different interventions in both groups|Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h||||hours||Standard Deviation|Mean
2590455|NCT02283814|Primary|Cmax - the Maximum Plasma Concentration|BIA 2-194 and BIA 2-195 are metabolites/active forms of eslicarbazepine acetate|Time Frame: Group A:Day 8 and 27: within 5 minutes prior to dosing and 0.5,1,1.5,2,2.5,3,3.5,4,6,9,12,16 and 24 hours after drug administration; Group B: Day 8 and 27 within 5 minutes prior dosing and 0.25,0.5,0.75,1,1.33,1.67,2,2.5,3,4,6,9,12,16 and 24h||||ng/mL||Standard Deviation|Mean
2590456|NCT02283788|Secondary|QTcF - QT Interval Corrected Using Fridericia's Formula||-30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose|||||||
2590457|NCT02283788|Secondary|QTcB - QT Interval Corrected for Heart Rate Using Bazett's Formula||-30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose|||||||
2590458|NCT02283788|Primary|QTcI - QT Interval Individually Corrected for Heart Rate - Day 5||-30 minutes (pre-dose) 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 23.5 hours post-dose||||msec||Standard Deviation|Mean
2590459|NCT02283762|Secondary|Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted to Week 52|Negative change in FVC percent predicted indicates worsening.|Baseline to week 52|FAS with evaluable data for this outcome measure.|||FVC percent predicted||Standard Deviation|Mean
2590460|NCT02283762|Secondary|Change From Baseline in Physician's Global Assessment Score to Week 52|The physician's global assessments (reported by the physician) quantified the overall disease activity or severity of SSc, with scores ranging from 0 (good) to 10 (worse). Positive change in the physician's global assessments score indicates worsening.|Baseline to week 52|FAS with evaluable data for this outcome measure.|||score on a scale||Standard Deviation|Mean
2590461|NCT02283762|Secondary|Change From Baseline in Patient's Global Assessment Score to Week 52|The patient's global assessments (a self-report) quantified the overall disease activity or severity of SSc, with scores ranging from 0 (good) to 10 (worse). Positive change in the patient's global assessments score indicates worsening.|Baseline to week 52|FAS with evaluable data for this outcome measure.|||score on a scale||Standard Deviation|Mean
2590462|NCT02283762|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score to Week 52|The HAQ-DI is a composite measure from which a 'Standard Disability Index' score can be computed to assess a patient's disability level. Generally, a score of 0-1 represents mild to moderate difficulty, 1-2 moderate to severe disability and 2-3 severe to very severe disability. The HAQ-DI comprises 20 items that assess patient abilities across 8 functional activities: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item is rated on a 4-point scale: 0=Without ANY difficulty, 1=With SOME difficulty, 2=With MUCH difficulty, 3=UNABLE to do. The 8 scores of the 8 sections are summed and divided by 8. In the event that one section is not completed by a subject then the summed score would be divided by 7. The final overall HAQ-DI score ranges from 0 to 3 and positive change indicates worse health-related quality of life (HRQoL).|Baseline to week 52|FAS with evaluable data for this outcome measure.|||score on a scale||Standard Deviation|Mean
2590463|NCT02283762|Secondary|CRISS (American College of Rheumatology Composite Response Index for Clinical Trials) at Week 52 Reported as Number of Participants With a CRISS Probability >=0.60 or <0.60 From Baseline to Week 52|CRISS forms a composite response index consisting of SSc-related organ involvement and the following five variables: mRSS, FVC percent predicted, physician's and patient's global assessments, and HAQ-DI score (from SHAQ patient-reported outcome). The resulting index is a 2-step process that captures clinically meaningful worsening of internal organ involvement and the core variables that show change. Patients for whom the predicted CRISS probability was ≥ 0.60 were considered improved, while patients for whom the predicted probability was < 0.60 were considered not improved.|Week 52|Full analysis set (FAS)|||Participants|||Count of Participants
2590464|NCT02283762|Primary|Change From Baseline in Modified Rodnan Skin Score (mRSS) to Week 52|The mRSS is a validated physical examination method for estimating skin thickness. It correlates with biopsy measures of collagen in the dermis and reflects prognosis and visceral involvement, especially in early disease. It is scored on 0 (normal) to 3+ (severe induration) ordinal scales over 17 body areas, with a maximum score of 51 (higher score means worse situation) and is used to categorize severity of SSc. A decrease in the mean change of mRSS shows mRSS improved.|Baseline to week 52|Full analysis set (FAS: all participants randomized and treated with study medication) with evaluable data for this outcome measure.|||score on a scale||Standard Deviation|Mean
2590465|NCT02283749|Secondary|Overall Survival of Patients With NSCLC and Bone Metastases and Stable or Responding Disease After Front-line Chemotherapy Treated With Xofigo|To measure overall survival of patients with NSCLC and bone metastases and stable or responding disease after front-line chemotherapy treated with Xofigo|During treatment (6 cycles, 1 cycle=4 weeks) and through 1 year post treatment||||Participants|||Count of Participants
2590466|NCT02283749|Secondary|Progression-free Survival of Patients With NSCLC and Bone Metastases and Stable or Responding Disease After Front-line Chemotherapy Treated With Xofigo|To measure progression-free survival of patients with NSCLC and bone metastases and stable or responding disease after front-line chemotherapy treated with Xofigo. Post 1 year of follow up the number of patients that remain stable or responding|During treatment (6 cycles, 1 cycle=4 weeks) and through 1 year post treatment|Post 1 year of follow up the number of patients that remain stable or responding|||Participants|||Count of Participants
2590467|NCT02283749|Primary|Number of Symptomatic Skeletal Events (SSE) in Patients Receiving Xofigo With NSCLC and Bone Metastases|Number of Participants with Symptomatic Skeletal Events (SSE) Receiving Xofigo With NSCLC and Bone Metastases|Approximately every 2 months for up to a year||||Number of participants experiencing SSE|||Number
2590468|NCT02283658|Other Pre-specified|Responsiveness of Tumors to Letrozole and Everolimus|"Response will be defined as tumors with at least a 50% reduction in tumor volume at study end. Unresponsive will be defined as tumors with less than 10% tumor volume reduction at study end. Intermediate values will be defined as Stable. Tumor growth curves will be plotted graphically and notated to indicate the outcome status of the originating patients. End of study tumor volumes will be correlated with outcome status of the originating patient as well. The Fisher's Exact test will be used to measure the associations."|28 days following treatment initiation|||||||
2590469|NCT02283658|Other Pre-specified|Response Rates to Letrozole and Everolimus in PDX Avatars|Will determine if response rates to letrozole and everolimus in PDX avatars correlate to responses noted in the patients. The Fisher's Exact test will be used to measure the associations.|28 days following treatment initiation|||||||
2590470|NCT02283658|Other Pre-specified|Expression of Molecular Biomarkers Associated With a Response to Treatment With Letrozole and Everolimus in Patients With Relapsed Ovarian Carcinomas|The Fisher's Exact test will be used to measure the associations.|28 days following treatment initiation|||||||
2590471|NCT02283658|Secondary|Progression Free Survival (PFS)|"PFS will be estimated using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Disease progression in evaluable patients will be defined as one or more of the following:~Any new disease and/or clear progression of evaluable disease; OR 2 fold elevation in CA-125 from its lowest level (either initial level or nadir, whichever is lowest, since study enrollment) combined with CA-125 elevation confirmed by re-assay at any time."|Time from registration to the first of either disease progression or death from any cause, assessed up to 2 years|All evaluable patients|||Months||95% Confidence Interval|Median
2590472|NCT02283658|Secondary|Overall Suravival(OS)|OS will be estimated using the method of Kaplan-Meier.|Time from registration to death from any cause, assessed up to 2 years|All evaluable patients|||Months||95% Confidence Interval|Median
2590473|NCT02283658|Secondary|Number of Participants Experiencing Adverse Events|The number of patients with adverse events.The maximum grade for each type of adverse event (AE) will be recorded for each patient, and frequency tables will be reviewed to determine AE patterns. These tables are reported in the adverse events section of this report.|Up to 30 days post-treatment|All evaluable patients|||Participants|||Count of Participants
2590474|NCT02283658|Secondary|Confirmed Response Rate, Estimated Using RECIST 1.1 Criteria|"A confirmed tumor response is defined to be either a complete response or partial response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. A complete response (CR) in evaluable patients will be defined as:~Disappearance of any sign of (evaluable) disease, AND~Normalization of CA-125; if CA-125 normalizes, it should be confirmed at any time.~A partial response (PR) in evaluable patients will be defined as:~Decrement in CA-125 by >50%, and~Improvement in any additional evaluable disease (if present) as assessed by the enrolling physician."|Up to 24 weeks|All evaluable patients|||percentage of patients||95% Confidence Interval|Number
2590475|NCT02283658|Secondary|Percentage of Participants With CA-125 Response|CA-125 response: The key secondary endpoint of the study will be a CA-125 response, defined as a 50% or greater reduction in baseline CA-125. The null hypothesis will be set at CA-125 response rate of 8.3%, based on the response of single agent letrozole, as reported by Bowman et al (7). The treatment of letrozole and everolimus will be considered promising, based on CA-125, if the observed CA-125 response rate is 30% or more.|Up to 2 years|All evaluable patients|||percentage of patients||95% Confidence Interval|Number
2590476|NCT02283658|Primary|Percentage of Patients Alive and Progression Free Survival at 12 Weeks|"The percentage of PFS12 successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the exact binomial method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Disease progression in evaluable patients will be defined as one or more of the following:~Any new disease and/or clear progression of evaluable disease; OR~2 fold elevation in CA-125 from its lowest level (either initial level or nadir, whichever is lowest, since study enrollment) combined with CA-125 elevation confirmed by re-assay at any time."|12 weeks|All evaluable patients|||percentage of patients||95% Confidence Interval|Number
2590477|NCT02283528|Secondary|Number of Participants With Complications Including Loosening of Archbars, Loosening of MMF, or Damage to Adjacent Teeth and Structures|assess operative and post-operative complications to include loosening of archbars, loosening of MMF if stratified to closed reduction and damage to adjacent teeth and structures|up to 6 weeks post operatively||||Participants|||Count of Participants
2590478|NCT02283528|Secondary|Number of Participants With Fracture Healing at 6 Weeks|Radiographic healing|6 weeks||||Participants|||Count of Participants
2590479|NCT02283528|Primary|Time to Place Archbars|Time taken to place archbars|During initial admission and surgery||||minutes||Standard Deviation|Mean
2590480|NCT02283411|Secondary|The Point Accuracy of the Device Performance Was Evaluated in Reference to Capillary Blood Glucose (BG).|Point accuracy of the system was evaluated as the proportion of System readings that are within ±20% of the capillary blood glucose (BG) value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for capillary blood glucose (BG) levels <80 mg/dL. All 125 subjects wore both System-P and System-Pro Sensors and were included in the outcome measure. System P, the Personal System which is intended for single patient use and System Pro is intended for use by healthcare professionals (HCP). Each subject had approximately112 capillary blood glucose (BG) samples collected during the study which were paired with sensor glucose readings measured at the same time. Point accuracy of the system was evaluated as the percentage of sensor glucose readings that are within ±20% of the BG value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for BG levels <80 mg/dL.|14 days|A total number of 11444 paired points between sensor glucose readings and BG glucose are used as the denominator to calculate the percentage of sensor glucose readings that are within ±20% of the BG reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for BG glucose levels <80 mg/dL.|||Percentage of paired points|Pairs||Number
2590508|NCT02282982|Secondary|Proportion of Participants Who Received Mechanical Ventilation While Hospitalized|The proportion of participants who received mechanical ventilation while hospitalized was documented.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test|||participants|||Number
2590481|NCT02283411|Secondary|The Temporal System Accuracy at Different Glucose Rates of Change and Different Glucose Ranges (Hypoglycemic, Euglycemic, and Hyperglycemic Ranges) Was Evaluated.|The Continuous Glucose Error Grid Analysis (CG-EGA) in the Hypoglycemic range (YSI ≤ 70 mg/dL), in the Euglycemic range (70 < YSI ≤ 180 mg/dL) and in the Hyperglycemic range (YSI > 180 mg/dL) were evaluated.|14 days|A total of 13566 paired points between sensor glucose readings and YSI glucose were used to calculate and evaluate the percentage of sensor glucose readings at different glucose rates of change and different glucose ranges (hypoglycemic, euglycemic, and hyperglycemic ranges) in System P only.|||% of paired points|Pairs||Number
2590482|NCT02283411|Secondary|The Trend Accuracy of the System P Device Performance Was Evaluated.|Trend accuracy of the device performance was assessed by comparing of the glucose rate of change results between the sensor glucose readings and YSI reference results for System P only.|14 days|A total number of 13566 paired points between sensor glucose readings and YSI glucose are used as the denominator to calculate the absolute difference between the rates of change corresponding to Sensor Reading (GM) and YSI results.|||Percentage of paired points|Pairs||Number
2590483|NCT02283411|Primary|Safety of the Abbott Sensor Based Glucose Monitoring Systems Was Characterized by Adverse Device Effects and Serious Adverse Device Effects Experienced by Study Participants.|Safety of the Abbott Sensor Based Glucose Monitoring Systems, including adverse device effects and serious adverse device effects were assessed for all participants enrolled in the study.|Safety was evaluated throughout the subject's study participation.|All 125 subjects who participated in the study are included in this outcome measure.|||Participants|||Count of Participants
2590484|NCT02283411|Primary|The Device Performance Was Evaluated in Terms of Point Accuracy of the Abbott Sensor Based Glucose Monitoring Systems in Reference to Yellow Spring Instrument (YSI).|Point accuracy of the system was evaluated as the proportion of System readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels <80 mg/dL. All 125 subjects wore both System-P and System-Pro Sensors and were included in the outcome measure. System P, the Personal System which is intended for single patient use and System Pro is intended for use by healthcare professionals (HCP). Each subject had up to 136 YSI samples collected during the study which were paired with sensor glucose readings measured at the same time. Point accuracy of the system was evaluated as the percentage of sensor glucose readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels <80 mg/dL.|14 days|A total number of 14284 paired points between sensor glucose readings and YSI glucose are used as the denominator to calculate the percentage of sensor glucose readings that are within ±20% of the YSI reference value for glucose levels ≥ 80 mg/dL and within ±20 mg/dL for YSI glucose levels <80 mg/dL.|||percentage of paired points|Pairs||Number
2590485|NCT02283268|Secondary|Pharmacokinetics: Volume of Distribution at Steady State (Vss)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. Vss will be calculated as the clearance multiplied with the mean residence time.~PK analysis was performed for the following analytes:~VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.|||dL/kg||Geometric Coefficient of Variation|Geometric Mean
2590486|NCT02283268|Secondary|Pharmacokinetics: Elimination Phase Half-life (T1/2)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. Terminal or disposition half-life (T1/2) will be calculated as ln2/λz where λz is the terminal elimination rate constant as calculated in WinNonlin NCA using at least three quantifiable concentrations.~PK analysis was performed for the following analytes:~VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.|||hours||Geometric Coefficient of Variation|Geometric Mean
2590487|NCT02283268|Secondary|Pharmacokinetics: Incremental Recovery (IR)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. Incremental recovery will be calculated as (Cmax minus Cpreinfusion) divided by the dose (IU/kg) where kg refers to the body weight at the time of dosing and Cmax is the observed maximum concentration before correction for pre-infusion values.~PK analysis was performed for the following analytes:~VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.|||IU/dL||Standard Deviation|Mean
2590488|NCT02283268|Secondary|Pharmacokinetics: Clearance (CL)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. Clearance will be calculated as dose (IU/kg) divided by the area under the curve time 0 to infinity.~PK analysis was performed for the following analytes:~VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.|||dL/hour/kg||Geometric Coefficient of Variation|Geometric Mean
2605745|NCT02107014|Primary|Change in IL-23 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2590489|NCT02283268|Secondary|Pharmacokinetics: Mean Residence Time (MRT)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. Mean residence time will be calculated as area under the first moment curve from time 0 to infinity divided by the area under the curve time 0 to infinity minus T/2 where T is the duration of the infusion.~PK analysis was performed for the following analytes:~VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.|||hours||Geometric Coefficient of Variation|Geometric Mean
2590490|NCT02283268|Secondary|Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC 0-∞ /Dose)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. The area under the plasma concentration/time curve from time 0 to infinity and the area under the first moment curve from time 0 to infinity will be calculated as the sum of AUC or AUMC from time 0 to the time of last quantifiable concentration plus a tail area correction calculated as Ct/λz and Ct/λz(t+1/λz), respectively, where Ct is the last quantifiable concentration, t is the time of last quantifiable concentration and λz is the terminal or disposition rate constant.~PK analysis was performed for the following analytes:~VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac), FVIII Coagulation Activity (FVIII:C)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.|||hours*IU/dL||Geometric Coefficient of Variation|Geometric Mean
2590491|NCT02283268|Secondary|Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Post-infusion (AUC 0-72 h/Dose)|"This assessment is only required for subjects undergoing major surgery. Subjects will receive a PK infusion at a dose of 50±5 IU/kg rVWF:RCo within 42 days prior to surgery. The area under the plasma concentration/time curve from 0 to 72 hours post-infusion will be computed using the linear trapezoidal rule. For the calculation of AUC(0-72h) the levels at 72 hours will be linearly interpolated/extrapolated from the 2 nearest sampling time points.~PK analysis was performed for the following analytes:~VWF Ristocetin Cofactor Activity (VWF:RCo), VWF Antigen Activity (VWF:Ag), VWF Collagen Binding Activity (VWF:CB), VWF Activity Measured INNOVANCE VWF Ac Assay (VWF:Ac), FVIII Coagulation Activity (FVIII:C)"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 30 (± 5) minutes, 60 (± 5) minutes, 6 (± 1) hours, 12 (± 1) hours, 24 (± 2) hours, 48 (± 2) hours and 72 (± 2) hours.|The PK analysis data set, including all participants who underwent PK assessment with data collected at the relevant time points, was used for analysis of this outcome measure.|||hours*IU/dL||Geometric Coefficient of Variation|Geometric Mean
2590492|NCT02283268|Secondary|Number of Participants Who Developed Antibodies to Chinese Hamster Ovary (CHO) Proteins, Mouse Immunoglobulin G (IgG) or Recombinant Furin (rFurin)|Participants were treated with recombinant van Willebrand Factor (rVWF) with or without ADVATE.|Testing occurred throughout the study at screening, prior PK infusion, pre-surgery, post surgery in case of excessive bleeding or unexplained bleeding, at postoperative day 7 and at study completion visit (ie. 14 (± 2) days post surgery).|The safety analysis data set, including all participants who received any amount of investigational product, was used for analysis of this outcome measure.|||Participants|||Count of Participants
2590493|NCT02283268|Secondary|Number of Participants Who Developed Inhibitory and Total Binding Antibodies to Von Willebrand Factor (VWF) and Inhibitory Antibodies to Factor VIII (FVIII)|Participants were treated with recombinant van Willebrand Factor (rVWF) with or without ADVATE.|Testing occurred throughout the study at screening, prior PK infusion, pre-surgery, post surgery in case of excessive bleeding or unexplained bleeding, at postoperative day 7 and at study completion visit (ie. 14 (± 2) days post surgery).|The safety analysis data set, including all participants who received any amount of investigational product, was used for analysis of this outcome measure.|||Participants|||Count of Participants
2590494|NCT02283268|Secondary|Occurrence of Severe Allergic Reactions (eg, Anaphylaxis)|Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) will be evaluated for severe allergic reactions.|From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery)|The safety analysis data set, including all participants who received any amount of investigational product, was used for analysis of this outcome measure.|||Adverse Events|||Number
2590495|NCT02283268|Secondary|Occurrence of Thrombotic Events|Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) will be evaluated for thrombotic events.|From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery)|The safety analysis data set, including all participants who received any amount of investigational product, was used for analysis of this outcome measure.|||Adverse Events|||Number
2590496|NCT02283268|Secondary|Occurrence of Adverse Events|Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) will be evaluated.|From first infusion of investigational product through study completion (ie, 14 (± 2) days post surgery)|The safety analysis data set, including all participants who received any amount of investigational product, was used for analysis of this outcome measure.|||Adverse Events|||Number
2590497|NCT02283268|Secondary|Daily Intra- and Postoperative Weight-adjusted Dose of rVWF With or Without ADVATE||Daily, from day of surgery through postoperative Day 14 (± 2 days)|Number of participants analyzed is different for the time points according to individual treatment. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis.|||IU/kg||Inter-Quartile Range|Median
2590509|NCT02282982|Secondary|Proportion of Participants Who Received Supplemental Oxygen While Hospitalized|The proportion of participants who received supplemental oxygen while hospitalized was documented.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test|||participants|||Number
2590498|NCT02283268|Secondary|Intraoperative Hemostatic Efficacy Score as Assessed by the Operating Surgeon|"Hemostatic efficacy will be rated on a scale of excellent - good - moderate - none.~Excellent: Intraoperative hemostasis achieved with rVWF with our without ADVATE was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal subject.~Good: Intraoperative hemostasis achieved with rVWF with or without ADVATE was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal subject.~Moderate: Intraoperative hemostasis with rVWF with or without ADVATE was clearly less than optimal for the type of procedure performed but was maintained without the need to change the rVWF concentrate.~None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of rVWF concentrate."|Day 0 (at completion of surgery)|Number of participants with major, minor and oral surgery and number of participant with Von Willebrand Type 1, 2A, 2B, 2M and 3 do sum up to the overall number of participants analyzed. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis.|||Participants|||Count of Participants
2590499|NCT02283268|Secondary|Intraoperative Actual Versus Predicted Blood Loss Score as Assessed by the Operating Surgeon|"Hemostatic efficacy will be rated on a scale of excellent - good - moderate - none.~Excellent: Intraoperative blood loss was less than or equal to the maximum blood loss expected for the type of procedure performed in a hemostatically normal subject (≤ 100%).~Good: Intraoperative blood loss was up to 50% more than the maximum expected blood loss for the type of procedure performed in a hemostatically normal subject (101-150%) Moderate: Intraoperative blood loss was more than 50% of the maximum expected blood loss for the type of procedure performed in a hemostatically normal subject (>150%).~None: Uncontrolled hemorrhage that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of clotting factor replacement regimen."|Day 0 (at completion of surgery)|Number of participants with major, minor and oral surgery and number of participant with Von Willebrand Type 1, 2A, 2B, 2M and 3 do sum up to the overall number of participants analyzed. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis.|||Participants|||Count of Participants
2590500|NCT02283268|Secondary|Intraoperative Actual Blood Loss Relative to Predicted Blood Loss|Actual blood loss relative to predicted blood loss will be calculated as [Actual Blood loss (mL)] divided by [Predicted Blood Loss (mL) multiplied by 100.|Day 0 (at completion of surgery)|Number of participants analyzed is 11, as for 3 participants the actual and the predicted blood loss was zero and for 1 participant the predicted blood loss was not collected. Therefore 'actual blood loss relative to predicted blood loss' could not be calculated. The full analysis data set was used for the analysis of this outcome measure.|||Percent||Standard Deviation|Mean
2590501|NCT02283268|Secondary|Intraoperative Actual Versus Predicted Blood Loss as Assessed by the Operating Surgeon|"The predicted blood loss will be estimated preoperatively by the operating surgeon based on a hemostatically normal individual of the same sex, age, stature and co-morbidities as the participant.~The actual blood loss will be assessed consisting of the estimated blood loss, including into swabs, towels and suction during the procedure, per the anesthesiologist's record."|Day 0 (at completion of surgery)|For predicted blood loss the number of participants analyzed is 14 as for one participant (included in the major surgery reporting group) the predicted blood loss was not collected. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis.|||mL||Standard Deviation|Mean
2590502|NCT02283268|Primary|Overall Hemostatic Efficacy as Assessed by the Investigator (Hemophilia Physician)|"Hemostatic efficacy will be rated on a scale of excellent - good - moderate - none.~Excellent: Intra-, and postoperative hemostasis achieved with rVWF with our without ADVATE was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal subject.~Good: Intra-, and postoperative hemostasis achieved with rVWF with or without ADVATE was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal subject.~Moderate: Intra-, and postoperative hemostasis with rVWF with or without ADVATE was clearly less than optimal for the type of procedure performed but was maintained without the need to change the rVWF concentrate.~None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of rVWF concentrate."|24 hours after last peri-operative infusion or at completion of Day 14 (± 2 days) visit, whichever occurs earlier|Number of participants with major, minor and oral surgery and number of participant with Von Willebrand Type 1, 2A, 2B, 2M and 3 do sum up to the overall number of participants analyzed. The full analysis data set, including all participants who received investigational product and have at least 1 hemostatic assessment, was used for analysis.|||Participants|||Count of Participants
2590503|NCT02282982|Secondary|Proportion of Participants With a Particular Co-morbidity|The proportion of participants with co-morbidities was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).|Approximately 7 months|Infants who received immunoprophylaxis during the RSV season|||participants|||Number
2590504|NCT02282982|Secondary|Median Duration of Oxygen Administration During Hospitalizations|The median duration of mechanical oxygen administration during hospitalizations was calculated.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test|||days||Full Range|Median
2590505|NCT02282982|Secondary|Median Duration of Mechanical Ventilation Administration During Hospitalizations|The median duration of mechanical ventilation administration during hospitalizations was calculated.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test|||days||Full Range|Median
2590506|NCT02282982|Secondary|Proportion of Participants With Co-morbidities During Hospitalizations|The proportion of participants with co-morbidities during hospitalizations was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10).|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test|||participants|||Number
2590507|NCT02282982|Secondary|Proportion of Participants With Missed Doses of Palivizumab|The proportion of participants with missed or delayed doses of palivizumab was documented.|Approximately 7 months|Infants who received immunoprophylaxis during the RSV season|||participants|||Number
2590510|NCT02282982|Secondary|Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU)|The median length of stay of hospitalized participants in the Intensive Care Unit was calculated.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test|||days||Full Range|Median
2590511|NCT02282982|Secondary|Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants|The number of hospitalized participants admitted to the Intensive Care Unit was documented.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test|||participants|||Number
2590512|NCT02282982|Secondary|Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test|The duration of hospitalizations due to LRTI which were accompanied by a positive RSV diagnostic test was documented.|Approximately 7 months|Participants who were hospitalized due to Lower Respiratory Tract Infection and who had a positive Respiratory Syncytial Virus laboratory diagnostic test|||days||Full Range|Median
2590513|NCT02282982|Primary|Proportion of Infants Who Died From a Confirmed Respiratory Syncytial Virus (RSV) Infection|Deaths caused by RSV during the study were to be confirmed by autopsy or clinical history and positive virologic diagnostic tests.|Approximately 7 months|Infants who received immunoprophylaxis during the RSV season|||participants|||Number
2590514|NCT02282982|Primary|Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test|Hospitalizations for LRTI with positive RSV diagnostic tests were documented at study visits.|Approximately 7 months|Infants who received immunoprophylaxis during the RSV season|||participants|||Number
2590515|NCT02282930|Secondary|Number of Subjects to Develop an Infection|The number of subjects with infections was defined as the development of pneumonia or complicated urinary tract infection/Pyelonephritis|12 months||||Participants|||Count of Participants
2590516|NCT02282930|Primary|Number of Subjects With a Complete or Partial Response to Treatment|"A complete response is defined by <300 mg proteinuria/24 hours and no greater than a 10% reduction in glomerular filtration rate (GFR) as determined by quantified creatinine clearance.~A partial response is defined by >50% reduction in 24 hour proteinuria and no greater than a 25% reduction in baseline GFR as quantified creatinine clearance.~No response is defined by < or equal to 50% reduction, unchanged or increasing proteinuria over baseline levels and a greater than a 25% reduction in baseline GFR as quantified creatinine clearance."|12 Months||||Participants|||Count of Participants
2590517|NCT02282813|Secondary|Number of Participants in the Per Protocol Population With NormalSerum 25-hydroxyvitamin D at End of Treatment (EOT)|Number of Participants in the per protocol population with serum 25-hydroxyvitamin D >/= 30 ng/mL at End of Treatment (EOT)|up to 6 months|Per protocol|||participants|||Number
2590518|NCT02282813|Secondary|Number of Participants in the Intent to Treat Population With Normal Serum 25-hydroxyvitamin D at End of Treatment (EOT)|Number of Participants in the Intent to Treat Population with serum 25-hydroxyvitamin D >/= 30 ng/mL at End of Treatment (EOT)|up to 6 months|Intent to treat|||participants|||Number
2590519|NCT02282813|Secondary|Number of Participants in the Per Protocol Population With Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT)|Number of subjects in the per protocol population with a mean reduction in plasma intact parathyroid hormone (iPTH) of >/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders|up to 6 months|Per protocol|||participants|||Number
2590520|NCT02282813|Primary|Number of Participants in the Intent to Treat Population With a Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT)|Number of subjects in the intent to treat population with a mean reduction in plasma intact parathyroid hormone (iPTH) of >/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders|up to 6 months|Intent to treat|||participants|||Number
2590521|NCT02282722|Secondary|Patient-Reported Prognostic Understanding in Median Years|Prognostic understanding was assessed by asking patients about their understanding of the prognosis of the typical patient with their condition (<1 year, 1-2 years, 2- 3 years, 3-5 years, 5-10 years, >10 years). This measure was adapted from the CANCORS trial.|3 months||||years||Inter-Quartile Range|Median
2590522|NCT02282722|Secondary|Emotional Distress When Making a Chemotherapy Treatment Choice: FACT-G Assessment|Emotional distress was assessed via the emotional wellbeing subscale of the FACT-G. Scores range from 0-24, with higher scores being more desirable.|3 months||||units on a scale||Standard Deviation|Mean
2590523|NCT02282722|Secondary|Decisional Regret When Making a Chemotherapy Treatment Choice: Decisional Regret Scale|Decisional Regret was assessed at the 3-month survey using Brehaut's 5-item decisional regret scale, with scores ranging from 0-100, where 100 indicates maximal regret, and 0 indicates no regret.|3 months||||units on a scale||Standard Deviation|Mean
2590524|NCT02282722|Secondary|Number of Participants Who Have End-of-life Discussions With Healthcare Proxy and Care Team||3 months||||Participants|||Count of Participants
2590525|NCT02282722|Secondary|Satisfaction When Making a Chemotherapy Treatment Choice: PACE Scores|"Satisfaction with communication during treatment decision-making process was assessed via 5 items from the Patient Assessment of Cancer Communication Experiences (PACE). Scores were averaged (does not apply excluded), creating a score of 1 to 4, with 4 being the most satisfied."|2 weeks||||units on a scale||Standard Deviation|Mean
2590526|NCT02282722|Secondary|Number of Participants Who Achieve Their Preferred Role in Treatment Decision Making Process|Achievement of preferred role in decision-making was assessed by the Control Preferences Scale; patients indicate the role they played in their treatment decision which is compared to their preferred role (assessed at baseline).|2 weeks||||Participants|||Count of Participants
2590527|NCT02282722|Secondary|Decisional Conflict When Making a Chemotherapy Treatment Choice: Modified SURE Scores|Decisional Conflict was assessed by a modified version of the 4 item SURE instrument of Legare at al which assesses whether patients 1) are sure of the best treatment option, 2) know the risks and benefits of their treatment options, 3) are clear about which risks and benefits matter to them, and 4) whether they have sufficient support to make their treatment decision. We expanded items 2 and 3 into four separate items assessing risks and benefits individually. Responses were summed, resulting in a scale of 0-6, where 0 indicates maximum conflict and 6 indicates no conflict|2 weeks||||units on a scale||Standard Deviation|Mean
2590528|NCT02282722|Secondary|Number of Participants With Accurate Understanding of the Goals of Palliative Chemotherapy|"Patients were asked according to your doctor, what is the goal of the chemotherapy? with the ability to choose any/all of the following response options: cure, control cancer growth, alleviate symptoms, prolong life, or other. Selecting either control cancer growth, and/or alleviate symptoms, and/or prolong life were defined as accurate understanding; to cure was considered inaccurate."|2 weeks||||Participants|||Count of Participants
2590529|NCT02282722|Secondary|Number of Patients With Accurate Understanding of Chemotherapy Risks|Patients were asked to rate the likelihood that they would experience specific side effects as a result of the chemotherapy under consideration, with separate items for nausea/vomiting, diarrhea, neuropathy, and hair loss. Patients' responses were correlated to the known side effect profile of their chemotherapy regimen and coded as accurate or inaccurate.|2 weeks||||Participants|||Count of Participants
2590530|NCT02282722|Primary|Number of Patients With Accurate Understanding of Chemotherapy Benefits|"Patients were asked How likely do you think that chemotherapy is to cure your cancer? with response options of not at all likely, a little likely, somewhat likely, very likely, and don't know. A response of not at all likely was considered accurate. All other responses, including don't know, were considered inaccurate."|3 months||||Participants|||Count of Participants
2590531|NCT02282631|Secondary|Number of Participants Who Met Physical Activity Guidelines|"Number of participants who met physical activity guidelines, i.e. at least 60 minutes of moderate-to-vigorous physical activity (MVPA) a day, measured by accelerometer (ActiGraph GT3X+); cut points of intensity by Evenson et al (2008) (sedentary <100 counts per minute (cpm); light >100cpm; moderate >=2296cpm; vigorous >=4012cmp), epoch 10 seconds. Valid wear was at least 6h/day on at least 3 days (weekdays or weekends).~NOTE: the above criterion of 10h/day for at least 5 days was changed before the start of the fieldwork, although not on this website. We found studies which suggested that wearing the accelerometer 6h/day on at least three days, with or without weekend days, were sufficient to assess overall levels of physical activity. Consistent with these findings, this new minimum wear criterion was adopted in the present study."|9 weeks|14 participants in the control school (2 dropouts after baseline) and 15 in the intervention school (0 dropouts). Participants wore the accelerometer twice in the study, for one week each time. N of valid recordings= N children who met the minimum wear target (6h/day on at least 3 days) overall; only valid recordings were used to assess overall PA|||N children who met PA guidelines|N of valid recordings available overall||Number
2590532|NCT02282631|Primary|Parental ATS Reports by SMS|"Number of parental ATS reports by SMS.~In this case, for comparability with data from paper reports, one SMS reports refers to a week in which at least one SMS report was received from the parent.~Parental SMS reports were only possible in those weeks when the child was not wearing the accelerometer. Parents who had chosen to report ATS by SMS were requested to report by paper on the weeks when the child wore the accelerometer (once at baseline, and once at post-baseline), and could report ATS by SMS in all other weeks."|8 weeks after baseline|- 'One SMS report' refers to a week in which at least one SMS report of ATS was received from the parent throughout the study. The above 'number of units analyzed' refers to the total number of weeks, for all participants, in which parents could have reported ATS throughout the study.|||N weeks with at least one SMS reply|N weeks with at least one SMS reply||Number
2590533|NCT02282631|Primary|Differences in MVPA During the Hour Before the Classes, Based on Child Report|differences in minutes of MVPA between ATS and non-ATS trips during the hour before the classes (7:56-8:55), based on child report (i.e. child reported whether trip was ATS or non-ATS)|9 weeks (one week at baseline plus eight weeks after baseline)|This outcome refers to trips to school reported, irrespective of the school where they were reported. There are no comparisons between control and intervention school due to the low number of non-active trips.|||minutes of MVPA|trips to school|Standard Deviation|Mean
2590534|NCT02282631|Primary|Differences in MVPA During the Times Reported by the Parent, Based on Child Report|differences in minutes of MVPA between ATS and non-ATS trips during the times reported by the parent as pertaining to the journey to school, based on child report (i.e. child reported whether trip was ATS or non-ATS)|9 weeks (one week at baseline plus eight weeks after baseline)|This outcome refers to trips to school reported, irrespective of the school where they were reported. There are no comparisons between control and intervention school due to the low number of non-active trips.|||minutes of MVPA|trips to school|Standard Deviation|Mean
2590535|NCT02282631|Primary|Differences in MVPA During the Hour Before the Classes, Based on Parental Report|differences in MVPA between ATS and non-ATS trips during the hour before the classes (7:56-8:55), based on parental report (i.e. parent reported whether trip was ATS or non-ATS)|9 weeks (one week at baseline plus eight weeks after baseline)|This outcome refers to trips to school reported, irrespective of the school where they were reported. There are no comparisons between control and intervention school due to the low number of non-active trips.|||minutes of MVPA|trips to school|Standard Deviation|Mean
2590536|NCT02282631|Primary|Differences in MVPA During the Times Reported by the Parent, Based on Parental Report|differences in minutes of moderate-to-vigorous physical activity (MVPA) between ATS and non-ATS trips during the times reported by the parent as pertaining to the journey to school, based on parental report (i.e. parent reported whether the trip was ATS or non-ATS)|9 weeks (one week at baseline plus eight weeks after baseline)|"Trips to school reported, irrespective of the school where they were reported. No comparisons between control and intervention school due to the low number of non-active trips. Number of Participants Analyzed in the ATS Trips Arm is the total N of participants whose parents reported ATS and provided data for MVPA. Likewise for Non-ATS Trips."|||minutes of MVPA|trips to school|Standard Deviation|Mean
2590537|NCT02282631|Primary|Active Travel to School Based on Child Report|Percentage of active trips to school based on child report. This data is from all the trips reported by children, whether parental reports exist for the same day or not. For that reason, this differs from the number of trips reported in 'Agreement Between Parent and Child Reports' because in that case, both parent and child reports were required for the same day.|9 weeks (one week at baseline plus eight weeks after baseline)|Children in Year 5 (age 9-10); reports of ATS were collected from the parent and from the child at baseline (week 0) and weekly during the post-randomisation period (week 1 to 8); ATS trips=active trips to school. This data are only from child reports of ATS.|||% ATS trips|N trips to school reported by child||Number
2590956|NCT02277639|Primary|Number of Participants With Engraftment|The primary objective is to determine event free survival with durable stable engraftment of donor cells at one year.|One Year||||Participants|||Count of Participants
2590538|NCT02282631|Primary|Active Travel to School Based on Parental Report|Active travel to school (ATS) refers to the behaviour of travelling to school by human-powered means as opposed to motorised transportation, for example by walking or cycling. This was based on parental ATS reports.|9 weeks (one week at baseline plus eight weeks after baseline)|Reports of ATS from parent and from child at baseline (week 0) and weekly during the post-randomisation period (week 1-8); ATS trips=active trips to school. This data is from all trips reported by the parent whether child ATS reports are available for the same days or not; this differs from N trips in 'Agreement Between Parent and Child Reports'|||% ATS trips|total N trips to school (parent-reported||Number
2590539|NCT02282631|Primary|Agreement Between Parent and Child Reports|"Inter-rater agreement between parent and child ATS* reports~*Active Travel to School"|9 weeks (one week at baseline plus eight weeks after baseline)||||Kappa score|N trips to school with both reports|95% Confidence Interval|Number
2590540|NCT02282631|Primary|Child ATS Reports Returned|"Number of child ATS* reports returned to the researcher (myself) throughout the study. Child ATS reports were always on paper.~*Active Travel to School"|9 weeks (one week at baseline plus eight weeks after baseline)|N of child ATS reports (always on paper) - is the total number of child ATS reports that could have been returned to the researcher throughout the study|||N child ATS reports returned|N of child ATS reports||Number
2590541|NCT02282631|Primary|Parental ATS Paper Reports Returned|"N parental ATS* paper reports returned to researcher(me)~*Active Travel to School~Paper reports with at least 1 box had been ticked out of the five boxes on the form (there was 1 box for each day of the week).~ATS reports were collected weekly, i.e. on the baseline week and on each of the eight post-baseline weeks. Accelerometers were only used twice; once at baseline (1week) and once at post-baseline (1week).~Parental paper ATS reports were preferred by 6 families, but on the 2 accelerometer weeks all participants had to use a paper reports including usual SMS respondents. In contr. group: all used paper reports at baseline (1st accel. week) (n=14), 6 usual paper respondents at post-baseline (6x8 weeks = 48), 6 SMS respondents who had to paper-report on the 2nd accel.week (both dropouts were SMS respondents & left too early for a 2nd accel.), so total N possible paper reports 14 + 48 + 6=68. Int. school: 15 participants & 8 usual paper respondents, total=15 + (8 x 8) + 7=86"|9 weeks (one week at baseline plus eight weeks after baseline)|The above number of participants corresponds to all participants in each group. The overall N of units analysed takes into account that although only some participants (6 in CG; 8 in IG) had chosen to report ATS by paper reports at baseline, everybody was expected to report by ATS paper report on the two weeks where the accelerometer was worn.|||N of parental ATS paper reports returned|N of parental ATS paper reports||Number
2590542|NCT02282631|Primary|Accelerometers Lost or Damaged|Number of accelerometers lost or damaged in this study|9 weeks (one week at baseline plus eight weeks after baseline)||||N of accelerometers lost or damaged|Total N times accelerometer was worn||Number
2590543|NCT02282631|Primary|Number of Participants Who Returned Their Accelerometers on Time at the End of the Post-baseline Week|Number of participants who returned their accelerometer on time to the researcher (myself) on the designated day, at end of post-baseline week. This was the second week of wear for participants. Whereas all participants were assessed concurrently at baseline, different subsamples were assessed every week at post-baseline.|8 weeks after baseline|Participants who stayed long enough in the study to wear the accelerometer a second time, at post-baseline|||Participants|||Count of Participants
2590544|NCT02282631|Primary|Number of Participants Who Returned Their Accelerometers on Time at the End of the Baseline Week|Number of participants who returned their accelerometer to the researcher on the designated day, at end of baseline week (all children wore the accelerometer at the same time)|1 week||||Participants|||Count of Participants
2590545|NCT02282631|Primary|Retention of Participants|Number of participants who remained in the study until the end.|September 2014 to December 2014|There were 14 participants in the control school, and 15 participants in the intervention school, at baseline. In the post-baseline weeks, there were two dropouts in the control school, and none in the intervention school.|||N children retained for the whole study|||Number
2590546|NCT02282631|Primary|Recruitment of Participants|Number of participants recruited in this study.|Sep 2014 to December 2014|Number of participants approached to take part in the study|||N of children who took part in the study|||Number
2590547|NCT02282631|Primary|School Retention|% of schools who were retained for the whole duration of the study (out of the two who took part)|September 2014 to December 2014||||% schools retained for the whole study|||Number
2590548|NCT02282631|Primary|Schools Who Accepted to Take Part|Percentage of schools who accepted to take part in this study|May 2014 to June 2014|123 schools were approached; 4 accepted to take part but only 2 were selected to take part|||% schools who accepted to take part|||Number
2590549|NCT02282605|Secondary|The Number of Participants With Changes in Vital Signs, ECG and Routine Haematology, Clinical Chemistry and Urinalysis Tests.||Assessed over the two day treatment period and follow-up at 7 and 14 days relative to the first dose.||||participants|||Number
2590550|NCT02282605|Secondary|AUC of the Semi-quantitative SA Scores From Nasal Swabs|Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Mean changes from baseline (0h) to each timepoint (Day 1,12 h; Day 2, 24 h: Day 3, 48h; Day 4, 84h; Day 7, 144h; Day 14, 312h) were calculated by treatment for the semi-quantitative SA scores. The AUC of the semi-quantitative SA scores were calculated for the two-day treatment period (AUC Day1- Day2); through the two day treatment period and up to discharge (AUC Day 1- Day4); and over the two-day treatment period, discharge and follow-up (AUC Day1- Day14). AUC was calculated by means of a trapezoidal rule using a standard algorithm. A higher AUC is indicative of a higher bacterial growth.|2 day treatment period; 2 day treatment period up to discharge; 2 day treatment period, discharge and follow-up|A comparison between treatment groups was performed separately for each AUC with an ANCOVA model with AUC as dependent variable, treatment as fixed effect and baseline SA (0 hours) as covariate. The AUC is a cumulative measure, comparison could be performed only within the same time period therefore data was normalised over time.|||units on a scale||Standard Deviation|Mean
2590551|NCT02282605|Secondary|Time-point at Which Clearance Was First Observed From Nasal Swabs Based on Semi-quantitative Score|The number of subjects with absence of SA from nasal swabs at the specified time-points..|Day 1 (12 h), Day 2 (24 h) , Day 3 (12 hours after last dose),Day 4 (48 hours after last dose)||||participants|||Number
2590552|NCT02282605|Secondary|Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method.|Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Scores of negative and 0 were interpreted as absence of SA (Responder) and scores of 1 or greater were interpreted as presence of SA (Non-Responder).|Time-points: Day 1(12 hours), Day 2 (24 hours), Day 3 (12 hours after last dose), Day 7 and Day 14.|Exploratory comparisons between active groups versus placebo of the percentage of Responder subjects were performed using a one-sided Fisher's exact test at 5% significance level.|||participants|||Number
2590553|NCT02282605|Primary|Apparent Eradication of Nasal SA After the Last Dose of XF-73 Based on Semi-quantitative SA Scores From a Broth Enrichment Method.|Anti-SA activity was assessed by the quantification of SA colonisation using the broth enriched (semi-quantitative culture) 0-6 point scale. Scores of negative and 0 were interpreted as absence of SA (Responder) and scores of 1 or greater were interpreted as presence of SA (Non-Responder).|The primary endpoint was 48 hours after the last dose (Day 4, 84 hours).|Exploratory comparisons between active groups versus placebo of the number of Responder subjects were performed using a one-sided Fisher's exact test at 5% significance level.|||participants|||Number
2590554|NCT02282527|Secondary|Number of Subjects With Immunogenicity Response|Blood samples for immunogenicity testing were collected at Weeks 1 (Baseline), 9, 17, and 20. Any samples that tested positive for alpha₁-PI antibodies were tested for neutralizing antibodies and antibody titer. Immunogenicity testing was performed using validated assays in a multitiered approach. Samples collected at Week 1 (Baseline) and at Weeks 9 and 20 were tested for immunogenicity while samples collected at Week 17 were to be tested for immunogenicity only if deemed appropriate (eg, unexpected PK profile).|Weeks 1, 9, 17, and 20||||Participants|||Count of Participants
2590555|NCT02282527|Secondary|AUC(0-7 Days) Based on Functional Activity|The exploratory PK objective of this study was to demonstrate the bioequivalence of Liquid Alpha₁-PI 60 mg/kg to Prolastin-C 60 mg/kg, as measured by AUC from 0 to 7 days (AUC 0-7 days) using a functional activity assay of alpha₁-PI, at approximate steady state in subjects with AATD.|pre-dose, 0, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 1 day, 2 days, 5 days, 7 days post dose||||mg*h/mL||Standard Deviation|Mean
2590556|NCT02282527|Primary|AUC(0-7 Days) Based on Antigenic Content|The primary PK objective of this study was to demonstrate the bioequivalence of Liquid Alpha₁-PI 60 mg/kg to Prolastin-C 60 mg/kg, as measured by AUC from 0 to 7 days (AUC0-7days) using an antigenic content assay of alpha₁-PI, at approximate steady state in subjects with AATD.|pre-dose, 0, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 1 day, 2 days, 5 days, 7 days post dose||||mg*h/mL||Standard Deviation|Mean
2590557|NCT02282293|Secondary|Number of Routine Visits Measured Every 8 Weeks During Pregnancy for Which the Participants Had Anemia|Anemia (hemoglobin less than 11g/dL) measured every 8 weeks during pregnancy|Following administration of first dose of study drugs to delivery||||Routine visit done every 8 weeks|Routine visit done every 8 weeks||Count of Units
2590558|NCT02282293|Secondary|Composite Adverse Birth Outcome (Proportion With Low Birth Weight (<2500 gm), Spontaneous Abortion (<28 Weeks), Stillbirth (Fetal Demise ≥28 Weeks), Congenital Anomaly, or Preterm Delivery (<37 Weeks)|Proportion with low birth weight (<2500 gm), spontaneous abortion (<28 weeks), stillbirth (fetal demise ≥28 weeks), congenital anomaly, or preterm delivery (<37 weeks)|At delivery||||Participants|||Count of Participants
2590559|NCT02282293|Secondary|Number of Monthly Routine Visits With Positive Blood Samples for Parasites|Proportion of monthly routine blood samples positive by LAMP for parasites|Following administration of first dose of study drug to delivery||||visits with positive blood sample|visits with positive blood sample||Count of Units
2590560|NCT02282293|Secondary|Placental Parasitemia (Number of Women With Placental Blood Samples Positive for Malaria by Microscopy or PCR)|Proportion of placental blood samples positive for malaria by microscopy or PCR|At delivery|Out of all 100 enrolled women in each arm: four women in TS+Placebo arm and two women in TS+DP arm did not have placental blood specimens collected to analyze; One participant TS+Placebo arm did not have microscopy results; Only one placental blood specimen was collected for each woman|||Participants|||Count of Participants
2590561|NCT02282293|Secondary|Maternal Parasitemia at Delivery by Microscopy and LAMP|Proportion of women with parasitemia detected by microscopy or LAMP at delivery|At delivery|Out of all 100 enrolled women in each arm: two women in TS+Placebo arm did not have maternal blood specimens collected to analyze; One participant in Daily TS + Monthly DP pregnancy arm did not have blood slide completed for microscopy results but did have blood spot collected for LAMP analysis|||Participants|||Count of Participants
2590562|NCT02282293|Primary|Incidence of Malaria, Pregnant Women|The primary outcome will be the incidence of malaria, defined as the number of incident episodes per time at risk. Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days.|Time at risk will begin following administration of first dose of study drug to delivery||||Events per person-year|||Number
2590563|NCT02282293|Primary|Number of Participants With Placental Malaria|The primary outcome will be the prevalence of placental malaria based on placental histopathology and dichotomized into any evidence of placental infection (parasites or pigment) vs. no evidence of placental infection.|at delivery estimated to be within 10 to 30 weeks of study entry||||Participants|||Count of Participants
2590564|NCT02282111|Secondary|Percent Sample Contribution to Immunohistochemistry Diagnosis|Percentage of all samples from participants in whom biopsy specimen was adequate enough to contribute to immunohistochemistry diagnosis|30 days||||percentage of all samples||95% Confidence Interval|Number
2590565|NCT02282111|Secondary|Time of the Procedure|Time from the beginning of the incision or needle insertion, to completion of tissue acquisition by the techniques defined in the protocol.|Tissue sampling procedure, up to 60 minutes||||minutes||Inter-Quartile Range|Median
2590566|NCT02282111|Secondary|Technical Failure Rate|Percentage of procedures in whom sampling technique failed to take biopsy specimens|1 day||||percentage of procedures||95% Confidence Interval|Number
2590567|NCT02282111|Secondary|Histological Yield|This will be assessed by the percentage of patients whose samples were adequate for histopathological evaluation|30 days||||percentage of participants||95% Confidence Interval|Number
2590568|NCT02282111|Primary|Diagnostic Accuracy|Diagnostic accuracy is defined as the percentage of true positive and true negative biopsy specimens combined divided by total number of specimens|30 days||||percentage of all samples||95% Confidence Interval|Number
2590569|NCT02282020|Secondary|Number of Participants Who Experience at Least One Adverse Event (AE)|An AE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.|Maximum of 45 Months|The safety analysis set includes all participants who received at least 1 dose of randomized study treatment, olaparib or chemotherapy.|||Count of Participants|||Number
2590570|NCT02282020|Secondary|Geometric Mean Plasma Concentration of Olaparib||Day 1, 1 hour post-dose and Day 29 pre-dose|The pharmacokinetic (PK) analysis set includes all participants who received an olaparib dose and provided evaluable plasma concentration data.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2590571|NCT02282020|Secondary|Number of Participants Who Received Second Subsequent Chemotherapy or Died in BRCA Gene Population|BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).|Maximum of 45 Months|The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.|||Count of Participants|||Number
2590572|NCT02282020|Secondary|Number of Participants Who Received Subsequent Chemotherapy or Died in BRCA Gene Population|BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).|Maximum of 45 Months|The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.|||Count of Participants|||Number
2590573|NCT02282020|Secondary|Number of Participants Who Discontinued Study Treatment or Died in BRCA Gene Population|BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).|Maximum of 45 Months|The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.|||Count of Participants|||Number
2590574|NCT02282020|Secondary|Overall Survival (OS) in BRCA Gene Population|"BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).~OS in BRCA gene population was measured by the number of participants who died due to any cause."|Maximum of 45 Months|The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.|||Count of Participants|||Number
2590575|NCT02282020|Secondary|Number of Participants Who Experienced Second Progression or Death (PFS2) in BRCA Gene Population|BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).|Maximum of 45 Months|The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.|||Count of Participants|||Number
2590576|NCT02282020|Secondary|Number of Participants Who Experienced Disease Progression or Death in BRCA Gene Population by Blinded Independent Central Review (BICR)|"BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).~Progressive disease was defined as at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm."|Maximum of 45 Months|The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.|||Count of Participants|||Number
2590577|NCT02282020|Secondary|Objective Response Rate (ORR) in Breast Cancer Susceptibility (BRCA) Gene Population by Blinded Independent Central Review (BICR)|"BRCA gene population includes participants identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (eg, gene sequencing and large rearrangement analysis).~The number of participants with complete or partial response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria. Partial response is declared when there is a decrease in sum of target disease ≥ 30%. Complete response is declared when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each."|Maximum of 45 Months|The Measurable Disease Analysis Set (MDAS) includes all participants in the Full Analysis Set (FAS) with measurable disease at baseline (as per RECIST 1.1), determined using Blinded Independent Central Review.|||Count of Participants|||Number
2590578|NCT02282020|Secondary|Number of Participants Who Show an Improvement in TOI Score|The TOI score was derived from the sum of the scores of the 25 items included in the physical well-being (7 items), functional well-being (7 items), and additional concerns ovarian cancer subscale (11 items) of the FACT-O questionnaire Version 4. TOI score ranges from 0 to 100, a higher score indicates a higher health-related quality of life (HRQoL). A change in at least 10 points was considered clinically relevant.|Baseline (Day 1) to Week 48 (±1 week)|The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.|||Count of Participants|||Number
2590579|NCT02282020|Secondary|Mean Change From Baseline In Trial Outcome Index (TOI) Score|The TOI score was derived from the sum of the scores of the 25 items included in the physical well-being (7 items), functional well-being (7 items), and additional concerns ovarian cancer subscale (11 items) of the FACT-O questionnaire Version 4. A negative change in score from baseline indicated a worsening in symptoms.|Baseline (Day 1) to Week 48 (±1 week)|The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.|||Scores on a scale||Standard Deviation|Mean
2590580|NCT02282020|Secondary|Time to Response (TTR)|TTR was defined as the time from randomization until the date of first documented response by Blinded independent central review (BICR) assessment.|Maximum of 45 Months|The Measurable Disease Analysis Set (MDAS) includes all participants in the Full Analysis Set (FAS) with measurable disease at baseline (as per RECIST 1.1), determined using Blinded Independent Central Review.|||Months||Inter-Quartile Range|Median
2590581|NCT02282020|Secondary|Duration of Response (DoR)|Duration of response is the time from the first documentation of complete response (CR) or partial response (PR) until the date of progression or death, or the last evaluable RECIST assessment for participants that do not progress or progress after 2 missed assessments. Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was used to assess participant response to treatment.|Maximum of 45 Months|The Measurable Disease Analysis Set (MDAS) includes all participants in the Full Analysis Set (FAS) with measurable disease at baseline (as per RECIST 1.1), determined using Blinded Independent Central Review.|||Months||Inter-Quartile Range|Median
2590582|NCT02282020|Secondary|Time From Randomization To Study Treatment Discontinuation Or Death (TDT)|TDT was defined as the time from randomization to the earlier of the date of study treatment discontinuation or death.|Maximum of 45 Months|The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.|||Months||95% Confidence Interval|Median
2590583|NCT02282020|Secondary|Time From Randomization To Second Subsequent Therapy Or Death (TSST)|TSST was defined as the time from the date of randomization to the earlier of second subsequent chemotherapy start date following study treatment discontinuation, or death.|Maximum of 45 Months|The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.|||Months||95% Confidence Interval|Median
2590584|NCT02282020|Secondary|Time From Randomization To First Subsequent Therapy Or Death (TFST)|TFST was defined as the time from the date of randomization to the earlier of first subsequent therapy start date or death.|Maximum of 45 Months|The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.|||Months||95% Confidence Interval|Median
2590585|NCT02282020|Secondary|Time To Earliest Progression By RECIST 1.1 Or Cancer Antigen (CA) -125 Or Death|Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was used to assess participant response to treatment. CA-125 progression was assessed per Gynecological Cancer Intergroup (GCIG).|Maximum of 45 Months|The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.|||Months||95% Confidence Interval|Median
2590586|NCT02282020|Secondary|Overall Survival (OS)||Maximum of 45 Months|The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.|||Months||95% Confidence Interval|Median
2590587|NCT02282020|Secondary|Time From Randomisation to Second Progression (PFS2)|Time from randomization to PFS2 was defined as the time from the date of randomization to the earliest of the progression events subsequent to first progression or death. The date of second progression was recorded by the investigator and defined according to local standard clinical practice, and could involve objective radiological, clinical, cancer antigen-125 (CA-125) progression or death. CA-125 progression was assessed per Gynecological Cancer Intergroup (GCIG) criteria.|Maximum of 45 Months|The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.|||Months||95% Confidence Interval|Median
2590588|NCT02282020|Secondary|Progression Free Survival (PFS)|RECIST 1.1 criteria was used to assess participant response to treatment. PFS was defined as the time from randomization until the date of objective radiological disease progression according to RECIST 1.1 or death (by any cause in the absence of disease progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to disease progression (i.e., date of RECIST progression/death or censoring - date of randomization +1).|Maximum of 45 Months|The Full Analysis Set (FAS) includes all randomized participants and compares the treatment groups on the basis of randomized treatment, regardless of the treatment actually received. Participants who were randomized but did not subsequently go on to receive study treatment were included in the FAS.|||Months||95% Confidence Interval|Median
2590589|NCT02282020|Primary|Objective Response Rate (ORR)|"Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria was used by a Blinded Independent Central Review (BICR) to assess participant response to treatment~Objective Response Rate (ORR) is the number of participants with Complete Response (CR) or Partial Response (PR) in the Measurable Disease Analysis Set (MDAS). Complete response is declared when all lesions have disappeared or all lesions have disappeared and all nodal disease is < 10 mm each. Partial response is declared when there is a decrease in sum of diameters of target lesions ≥ 30%."|Maximum of 45 Months|The Measurable Disease Analysis Set (MDAS) includes all participants in the Full Analysis Set (FAS) with measurable disease at baseline (as per RECIST 1.1), determined using Blinded Independent Central Review.|||Count of Participants|||Number
2590590|NCT02281851|Primary|Difference in Resting Levels of Endogenous Antioxidant Proteins in Skeletal Muscle - Superoxide Dismutase 2 (SOD-2)|To examine the effects of habitual vitamin and antioxidant supplementation on endogenous antioxidant production, participants will have a muscle biopsy taken at rest to examine any differences in endogenous antioxidant protein concentrations|Protein concentrations will be measured at baseline only||||Arbitrary Units||Standard Deviation|Mean
2590591|NCT02281773|Secondary|Change in Psychopathology Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS)|Change in psychopathology symptoms as assessed by Positive and Negative Syndrome Scale (PANSS). It contains 30-items including seven positive symptom items, seven negative symptom items and 16 general psychopathology symptom items. Each item was scored on the same seven point severity scale. Fourteen of the PANSS items required input from an informant. Total score ranges from 30 to 210 (minimum is better). The descriptive statistics of change from baseline (CFB) in PANSS score at week 6 (W6) and week 12 (W12) are presented.|Baseline, Week 6 and Week 12|TS|||Unit on Scale||Standard Deviation|Mean
2590592|NCT02281773|Secondary|Change From Baseline in PANSS Negative Symptom Factor Score After 12 Weeks of Treatment (for Subset of Patients Diagnosed With Negative Symptom)|Change from baseline in PANSS negative symptom factor score after 12 weeks of treatment (for subset of patients diagnosed with negative symptom). This outcome measure was not analysed due to low number of patients in the PANSS negative symptom subgroup. The PANSS negative symptom scale has 7 items. Each was rated from one to 7 points. The total factor score was the summation of the 7 points for each item, leading the total score ranging from 7 to 49.|Baseline and Week 12|This endpoint was not analysed because as per internal Boehringer Ingelheim rules, descriptive statistics are not calculated if data is available for less than 2/3rds of participants.||||||
2590593|NCT02281773|Secondary|Patient Global Impressions-Improvement (PGI-I) Scale Score Measured After 12 Weeks of Treatment|Patient Global Impressions-Improvement (PGI-I) scale score measured after 12 weeks of treatment. The PGI of improvement is a simple evaluation completed by the patient to assess the patient's overall evaluation of his/her status. The PGI of improvement was rated ordinally from one to 7. Higher scores indicate more severe symptoms.|Up to 12 weeks|FAS|||Unit on Scale||Standard Deviation|Mean
2590594|NCT02281773|Secondary|Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Scale Score After 12 Weeks of Treatment|Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale score after 12 weeks of treatment. The CGI-S is a one-item evaluation completed by the clinician on the patient's severity of psychopathology. The CGI-S was rated ordinally from one to 7. Higher scores indicate more severe symptoms.|Baseline and Week 12|The full analysis set (FAS) was to consist of all randomisation patients who were treated with at least one dose of study drug and had a baseline and at least one post baseline on treatment primary endpoint MCCB composite score.|||Unit on Scale||Standard Error|Least Squares Mean
2590595|NCT02281773|Secondary|Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Global Ratings After 12 Weeks of Treatment|Change from baseline in everyday functional capacity as measured by Schizophrenia Cognition Rating Scale (SCoRS) global ratings after 12 weeks of treatment. SCoRS is a 20-item interview-based assessment of cognitive deficits and the degree to which they affect day-to-day functions. Each item was rated on a 4-point scale. Higher ratings reflected a greater degree of impairment. The SCoRS global total scores is the sum of the 20 items and it varies from 20 to 80 with 20 being the best outcome and 80 being the worst. If any individual item was missing, it was imputed with the average of that patient's non missing responses. If >5 items were missing, the total score was missing.|Baseline and Week 12|The full analysis set (FAS) was to consist of all randomisation patients who were treated with at least one dose of study drug and had a baseline and at least one post baseline on treatment primary endpoint MCCB composite score.|||Unit on Scale||Standard Error|Least Squares Mean
2590596|NCT02281773|Primary|Suicidality as Assessed by Columbia Suicidal Severity Rating Scale (C-SSRS)|"C-SSRS: Number (%) of subjects with an event of Suicidal Ideation (Wish to be dead, Non−specific active suicidal thoughts, Active suicidal ideation with any methods (not plan) without intent to act, Active suicidal ideation with some intent to act without specific plan, Active suicidal ideation with specific plan and intent) or Suicidal Behavior (Preparatory acts or behavior, Aborted attempt, Interrupted attempt, Non−fatal suicide attempt, Completed suicide) or Self−injurious behavior without suicidal intent is presented. C-SSRS used only to evaluate whether the patient developed suicidal ideation or behavior and no composite score will be used. Questions in the 1st section of suicidal ideation and suicidal behavior assessments in C-SSRS are yes and no type questions. If patient had suicidal ideation or behavior, 2nd section will be performed to evaluate the details with the scale from 0 to 5 or 0 to 2 and the larger number means the more severe condition."|Up to 12 weeks|TS (Number of subjects with a post baseline C−SSRS)|||Percentage of Participants|||Number
2590597|NCT02281773|Primary|Dramatic Worsening of Disease State as Assessed by Positive and Negative Syndrome Scale (PANSS)|Dramatic worsening of disease state as assessed by Positive and Negative Syndrome Scale (PANSS). It contains 30-items including seven positive symptom items, seven negative symptom items and 16 general psychopathology symptom items. Each item was scored on the same seven point severity scale. Fourteen of the PANSS items required input from an informant. Total score ranges from 30 to 210 (minimum is better). The descriptive statistics of change from baseline (CFB) in PANSS score at week 6 (W6) and week 12 (W12) are presented.|Baseline, Week 6 and Week 12|TS|||Unit on Scale||Standard Deviation|Mean
2590598|NCT02281773|Primary|Occurrence of Protocol-specified Adverse Events of Special Interest (AESI)|Occurrence of Protocol-specified adverse events of special interest (AESI).|Up to 20 weeks|The treated set (TS) was to consist of all patients who were randomised and treated with at least one dose of study drug.|||Percentage of Participants|||Number
2590599|NCT02281773|Primary|Occurrence of Serious Adverse Events (SAEs) (Including the Abnormalities of Physical Examination, Vital Signs, Electrocardiogram (ECG) Test and Laboratory Tests)|Occurrence of serious adverse events (SAEs) (including the abnormalities of physical examination, vital signs, electrocardiogram (ECG) test and laboratory tests).|Up to 20 weeks|The treated set (TS) was to consist of all patients who were randomised and treated with at least one dose of study drug.|||Percentage of Participants|||Number
2590676|NCT02280863|Secondary|Mean Glucose Values|Mean glucose values are reported as assessed by continuous glucose monitoring (CGM; subcutaneous sensor, day and night values).|Up to 10 days|Participants who completed the protocol were included in the analysis.|||mg/dL||Standard Deviation|Mean
2590600|NCT02281773|Primary|Change From Baseline in the Composite Score of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) After 12 Weeks of Treatment|"MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning problem solving, and social cognition. The composite score was calculated by summing over the standardised score of each domain for analysis and it varies from -20 to 99 with higher score indicating better outcome. The trial was set up as learn and confirm model including 2 stages. Stage 1 analysis was conducted to identify the meaningful cognition endpoint(s) (CANTAB domain(s)) and the selected endpoint(s) were to be pre-specified as the primary endpoint(s) for Stage 2 analysis. Since none of the CANTAB outcome measures was selected in the Stage 1 analysis at planned time based on the pre-specified criteria, the MCCB composite score was chosen as the primary endpoint in the Stage 2 analysis, as pre-defined."|Baseline and Week 12|The full analysis set (FAS) was to consist of all randomisation patients who were treated with at least one dose of study drug and had a baseline and at least one post baseline on treatment primary endpoint MCCB composite score.|||Unit on Scale||Standard Error|Least Squares Mean
2590601|NCT02281591|Secondary|AUC0-t - the Area Under the Plasma Concentration-time Curve to Last Measurable Time Point||Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.||||ng.h/mL||Standard Deviation|Mean
2590602|NCT02281591|Primary|AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity||Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.||||ng.h/mL||Standard Deviation|Mean
2590603|NCT02281591|Primary|Tmax - the Time of Occurrence of Cmax||Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.||||hours||Standard Deviation|Mean
2590604|NCT02281591|Primary|Cmax - the Maximum Plasma Concentration||Phase A: pre-dose (Day 1); and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.Phase B: Days 6 to 10 inclusively: pre-dose. Day 11 (last dose): pre-dose; and ½, 1, 1½,2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.||||ng/mL||Standard Deviation|Mean
2590605|NCT02281552|Other Pre-specified|Number of Participants With Clinically Significant Laboratory Test Abnormalities|Criteria: lipids(cholesterol[CH] milligrams/deciliter[mg/dL] >1.3*upper limit normal(ULN), high-density lipoprotein CH mg/dL <0.8*lower limit normal(LLN), Low-density lipoprotein CH mg/dL >1.2* ULN, triglycerides mg/dL >1.3*ULN); neutrophil count(NC) <1000 cells/cubic milliliters(mm^3), platelet counts(PC) <100,000 P/mm^3, lymphocyte counts(LC) <500 L/mm^3, any single (aspartate transaminase elevation(ASTE)/alanine transaminase elevation(ALTE) >=3*ULN, hemoglobin(Hb) value <8.0 grams(g)/dL or >=2 g/dL below baseline, any serum creatinine(SC) increase(inc) >50% or inc >0.5 mg/dL over the average of screening(OAS) and baseline values(BV), 2 sequential ASTE/ALTE>=3*ULN with total bilirubin value(TBV) >=2*ULN, ASTE/ALTE >=3*ULN, ASTE/ALTE >=5*ULN, Hb <8.0 g/dL or decrease of >30% from BV, PC <75,000 P/mm^3, NC <1000 cells/mm^3, LC <500 L/mm^3, confirmed inc in SC >50% OAS and BV and detection of hepatitis B virus-deoxyribonucleic acid(HBV-DNA) by the two sequential quantitative tests.|Baseline up to 12 weeks|Safety analysis set included all participants who were randomized and received at least one dose of the randomized investigational drug.|||participants|||Number
2590606|NCT02281552|Other Pre-specified|Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between first dose of study drug and up to 12 weeks that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non- serious adverse events.|Baseline up to 12 weeks|Safety analysis set included all participants who were randomized and received at least one dose of the randomized investigational drug.|||participants|||Number
2590607|NCT02281552|Secondary|Change From Baseline in the European Quality of Life - 5 Dimensions Questionnaire (EQ-5D) Scores at Week 12|EQ-5D was a participant completed instrument designed to assess impact on quality of life in terms of a single utility score in five domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with 3 possible answers for each item (1=no problem, 2=moderate problems, 3=severe problems). The 5-dimensional systems are converted into a single index utility score between 0 and 1, where higher score indicated a better health state.|Baseline, Week 12|"FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure."|||units on a scale||Standard Error|Least Squares Mean
2590608|NCT02281552|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Scores at Week 12|The FACIT-Fatigue Scale was a participant completed questionnaire consisted of 13 items that assessed fatigue. Each item was scored on a scale of 0 (not at all) to 4 (very much), Total score ranging from 0 (not at all) to 52 (very much), higher scores represented lower level of fatigue.|Baseline, Week 12|"FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure."|||units on a scale||Standard Error|Least Squares Mean
2590652|NCT02281136|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 Minutes after PDT||||participants|||Number
2591356|NCT02273037|Primary|Stillbirth and Neonatal Death|Compare the incidence of fresh stillbirth and neonatal death (within 24h of age) in the Pinard group (current practice) and the Doppler group (study intervention).|0-24hour of delivery||||Participants|||Count of Participants
2590609|NCT02281552|Secondary|Change From Baseline in the Short Form 36 (SF-36) Health Survey Component Scores at Week 12|SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: physical functioning, role physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of 8 health aspects were aggregated to derive the two component scores PCS and MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition.|Baseline, Week 12|"FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure."|||units on a scale||Standard Error|Least Squares Mean
2590610|NCT02281552|Secondary|Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12|SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: physical functioning, role physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of 8 health aspects were aggregated to derive the two component scores (physical component scores [PCS], mental component scores [MCS]) ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition.|Baseline, Week 12|"FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure."|||units on a scale||Standard Error|Least Squares Mean
2590611|NCT02281552|Secondary|Number of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ Scores) at Week 12|HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 categories of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities over past week. Each activity category consisted of 2-3 items. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities. Number of participants with an improvement of at least 0.22 units in HAQ scores from baseline to Week 12 were reported in this outcome measure.|Week 12|"FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method."|||participants|||Number
2590612|NCT02281552|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12|HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 categories of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities over past week. Each activity category consisted of 2-3 items. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.|Baseline, Week 12|"FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure."|||units on a scale||Standard Error|Least Squares Mean
2590613|NCT02281552|Secondary|Number of Participants With Low Disease Activity (DAS28-4-ESR <=3.2) at Week 12|DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (ESR) <2.6 implied remission. Number of participants with low disease activity (DAS28-4-ESR<=3.2) were reported in this outcome measure.|Week 12|"FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method."|||participants|||Number
2590614|NCT02281552|Secondary|Number of Participants With Low Disease Activity (DAS28-4-CRP <=3.2) at Week 12|DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (mg/L) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (CRP) <2.6 implied remission. Number of participants with low disease activity (DAS28-4-CRP<=3.2) were reported in this outcome measure.|Week 12|"FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method."|||participants|||Number
2590653|NCT02281136|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline||||participants|||Number
2603257|NCT02134119|Secondary|Hematological Measures - Erythropoietin|as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days||||mU/mL||Standard Deviation|Mean
2590615|NCT02281552|Secondary|Number of Participants With DAS Remission (DAS28-4-ESR <2.6) at Week 12|DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (ESR) <2.6 implied remission. Number of participants with DAS remission (DAS28-4-ESR<2.6) were reported in this outcome measure.|Week 12|"FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method."|||participants|||Number
2590616|NCT02281552|Secondary|Number of Participants With DAS Remission (DAS28-4-CRP <2.6) at Week 12|DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (mg/L) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (CRP) <2.6 implied remission. Number of participants with DAS remission (DAS28-4-CRP<2.6) were reported in this outcome measure.|Week 12|"FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method."|||participants|||Number
2590617|NCT02281552|Secondary|Number of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Week 12|Participants with 70% improvement in 68-tender and 66-swollen joint counts and 70% improvement in at least 3 of the 5 measures: patient's global assessment of arthritis, physician global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire-disability index(HAQ-DI) and CRP. Patient's global assessment of arthritis: participant assessed arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Physician global assessment of arthritis: physician judged participants arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Patient's assessment of arthritis pain: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (most severe pain), higher score implied more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.|Week 12|"FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method."|||participants|||Number
2590618|NCT02281552|Secondary|Number of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12|Participants with 50% improvement in 68-tender and 66-swollen joint counts and 50% improvement in at least 3 of the 5 measures: patient's global assessment of arthritis, physician global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire-disability index(HAQ-DI) and CRP. Patient's global assessment of arthritis: participant assessed arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Physician global assessment of arthritis: physician judged participants arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Patient's assessment of arthritis pain: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (most severe pain), higher score implied more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.|Week 12|"FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method."|||participants|||Number
2590619|NCT02281552|Secondary|Number of Participants Achieving an American College of Rheumatology 20 Percent [%] (ACR20) Response at Week 12|Participants with 20% improvement in 68-tender and 66-swollen joint counts and 20% improvement in at least 3 of the 5 measures: patient's global assessment of arthritis, physician global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire-disability index(HAQ-DI) and CRP. Patient's global assessment of arthritis: participant assessed arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Physician global assessment of arthritis: physician judged participants arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Patient's assessment of arthritis pain: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (most severe pain), higher score implied more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.|Week 12|"FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using non-responder imputation (NRI) method."|||participants|||Number
2590654|NCT02281136|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 4||||participants|||Number
2590706|NCT02280421|Primary|Area Under the Curve (AUC) of ASP2151||prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2590620|NCT02281552|Secondary|Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (Erythrocyte Sedimentation Rate [ESR]) at Week 12|DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeters per hour [mm/hr]) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (ESR) <2.6 implied remission.|Baseline, Week 12|"FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure."|||units on a scale||Standard Error|Least Squares Mean
2590621|NCT02281552|Primary|Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (C-Reactive Protein [CRP]) at Week 12|DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, CRP (milligrams per liter [mg/L]) and patient global assessment of disease activity on a 100 millimeter (mm) visual analog scale (VAS: scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) [less than or equal to] <= 3.2 implied low disease activity and greater than (>) 3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (CRP) less than (<) 2.6 implied remission.|Baseline, Week 12|"Full analysis set (FAS) included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure."|||units on a scale||Standard Error|Least Squares Mean
2590622|NCT02281526|Secondary|Cmax - Peak Plasma Concentration|Day 1 - Cmax Peak plasma concentration|pre-dose and 1, 2, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 7, 9, 12 and 24 hours post-dose.||||ng/mL||Standard Deviation|Mean
2590623|NCT02281526|Primary|Area Under the Plasma Concentration Versus Time Curve, AUC(0-tlast).|"Day 1 - Area under the plasma concentration versus time curve, AUC(0-tlast).~BIA 2-194, 2-195 Glucoronide, Oxcarbazepine, BIA 2-093 Glucoronide, 2-194 Glucoronide are BIA 2-093 metabolites."|pre-dose and 1, 2, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 7, 9, 12 and 24 hours post-dose.||||h·ng/mL||Standard Deviation|Mean
2590624|NCT02281448|Secondary|AUC0-t|AUC0-t (ng.h/mL) following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)|pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.||||pg.h/mL||Standard Deviation|Mean
2590625|NCT02281448|Secondary|Tmax|Tmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)|pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.||||h||Standard Deviation|Mean
2590626|NCT02281448|Secondary|Cmax|Cmax following administration of a single-dose of Microginon® concomitantly with the 14th dose of a 15-day oral regimen of BIA 2-093 1200 mg once-daily (Test) and following administration of a single-dose of Microginon® administered alone (Reference)|pre-dose, on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 of the BIA 2-093 + OC period.||||pg/mL||Standard Deviation|Mean
2590627|NCT02281448|Primary|Cmax - Maximum Observed Plasma BIA 2-194 Concentration|Cmax - Maximum observed plasma BIA 2-194 concentration on days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.|Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.||||ng/mL||Standard Deviation|Mean
2590628|NCT02281422|Primary|AUC(0-12h) - AUC From Time Zero to 12h|"BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites~AUC - area under the plasma concentration versus time curve"|pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose.||||ng*h/mL||Standard Deviation|Mean
2590629|NCT02281422|Secondary|Tmax (hr) - Time at Which Cmax Occurred|"BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites~Cmax - maximum observed plasma drug concentration"|pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose.||||hours||Standard Deviation|Mean
2590630|NCT02281422|Primary|Cmax - Peak Plasma Concentration|BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites|pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose.||||ng/mL||Standard Deviation|Mean
2590631|NCT02281357|Secondary|Annual Asthma Exacerbation Rate (AAER) up to Week 40.|"AAER up to Week 40 in the tralokinumab group was compared to that seen in the placebo group. The response variable was the number of exacerbations the patient experienced up to Week 40, with the logarithm of the time at risk in years of experiencing an exacerbation included as offset in the model.~AAER = number of exacerbations*365.25/(follow-up date - date of randomisation + 1).~Asthma exacerbation was defined as a worsening of asthma that led to any of the following:~Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids.~An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for <24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids.~An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma."|Baseline (Week 0) up to Week 40|The FAS included all randomised patients who received at least one dose of study treatment, irrespective of their protocol adherence and continued participation in the study.|||Adjusted rate (events/year)||95% Confidence Interval|Number
2590656|NCT02281136|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 Minutes after PDT||||participants|||Number
2590632|NCT02281357|Secondary|The Number of Patients With ≥50% Reduction in Final Average Daily OCS Dose at Week 40.|"The 40-week treatment period consisted of 3 phases: an induction phase (Week 0 to Week 12) where patients remained on their optimised OCS dose; an OCS reduction phase (Week 12 to Week 32) where OCS dose reduction could have started at Week 12 with the possibility of dose titration every 4 weeks to reach the lowest possible OCS dose; and a maintenance phase (Week 32 to Week 40) where patients remained on the OCS dose reached at Week 32 to demonstrate asthma control was maintained after achieving the lowest OCS dose.~The number of patients with ≥50% reduction in average daily OCS dose is presented. The final daily percent change from baseline was defined as {(Final daily average dose - baseline daily average dose)/baseline daily average dose}*100%. If this resulted in a value of -50% or less (more negative), that patient was classified as having at least a 50% reduction in final daily average OCS dose."|At Week 40|The FAS included all randomised patients who received at least one dose of study treatment, irrespective of their protocol adherence and continued participation in the study.|||Participants|||Count of Participants
2590633|NCT02281357|Secondary|The Number of Patients With Final Daily Average OCS Dose ≤5 mg at Week 40.|"The 40-week treatment period consisted of 3 phases: an induction phase (Week 0 to Week 12) where patients remained on their optimised OCS dose; an OCS reduction phase (Week 12 to Week 32) where OCS dose reduction could have started at Week 12 with the possibility of dose titration every 4 weeks to reach the lowest possible OCS dose; and a maintenance phase (Week 32 to Week 40) where patients remained on the OCS dose reached at Week 32 to demonstrate asthma control was maintained after achieving the lowest OCS dose.~The number of patients with a final daily average OCS dose ≤5.0 mg is presented. For patients prescribed a fixed daily dose, then the average OCS dose was defined as the prescribed dose. For patients on a regimen where a different amount of OCS was to be taken each day, then the average OCS dose was defined as the average amount prescribed to be taken each day."|At Week 40|The FAS included all randomised patients who received at least one dose of study treatment, irrespective of their protocol adherence and continued participation in the study.|||Participants|||Count of Participants
2590634|NCT02281357|Primary|Percent Change From Baseline in the Final Daily, Average, OCS Dose at Week 40 While Not Losing Asthma Control.|"The 40-week treatment period consisted of 3 phases: an induction phase (Week 0 to Week 12) where patients remained on their optimised OCS dose; an OCS reduction phase (Week 12 to Week 32) where OCS dose reduction could have started at Week 12 with the possibility of dose titration every 4 weeks to reach the lowest possible OCS dose; and a maintenance phase (Week 32 to Week 40) where patients remained on the OCS dose reached at Week 32 to demonstrate asthma control was maintained after achieving the lowest OCS dose. Criteria used to assess asthma control included lung function assessments (forced expiratory volume in 1 second and morning peak expiratory flow), night awakenings, and the use of rescue medication and systemic corticosteroids.~The least squares (LS) mean percent change from baseline in average daily OCS dose is presented. The final daily percent change from baseline was defined as {(Final daily average dose - baseline daily average dose)/baseline daily average dose}*100%."|Baseline (Week 0) and Week 40|The FAS included all randomised patients who received at least one dose of study treatment, irrespective of their protocol adherence and continued participation in the study.|||Percent change from baseline||Standard Error|Least Squares Mean
2590635|NCT02281318|Secondary|Mean Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score at Week 24|The ACQ-5 is a five-item questionnaire, designed to be self-completed by the participants. ACQ-5 score is the mean score of 5 questions, each assessed on a 0-6 point scale to give a mean ranging between 0-6 with lower scores indicating better outcome. The five questions inquired about the frequency and/or severity of symptoms over the previous week. The response options for all these questions consisted of a zero (no impairment/limitation) to six (total impairment/limitation) scale. The mean change from Baseline was calculated as the value at Week 24 minus the Baseline value for each participant and analyzed using a mixed model repeated measures allowing for covariates of Baseline value, region, Baseline maintenance OCS therapy, exacerbations in the year prior to the study (as an ordinal variable), Baseline % predicted FEV1 and visit, plus interaction terms for visit by Baseline and visit by treatment group.|Baseline and Week 24|mITT Population. Participants with a missing Baseline covariate value or with no observed change from Baseline at any time point were excluded from the analysis model.|||Scores on a scale||Standard Error|Least Squares Mean
2590636|NCT02281318|Secondary|Percentage of Participants Achieving a 4 Point or Greater Reduction From Baseline in SGRQ Score at Week 24|The percentage of participants achieving a 4 point or greater reduction from Baseline in SGRQ (scored from 0-100 with lower scores indicating better outcome) at Week 24 was compared between treatment groups using a logistic regression model with covariates of Baseline value, region, Baseline maintenance OCS therapy, exacerbations in the year prior to the study (as an ordinal variable) and Baseline % predicted FEV1.|Baseline (Visit 2-latest pre-dose assessment) and Week 24|mITT Population. Participants with a missing Baseline covariate value were excluded from the analysis model.|||Percentage of participants|||Number
2590637|NCT02281318|Secondary|Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Week 24|FEV1 is the volume of air that can be forced out in one second after taking a deep breath. The change from Baseline in pre-bronchodilator FEV1 was calculated as the value at Week 24 minus the value at Baseline for each subject and was analyzed using a mixed model repeated measures adjusting for Baseline absolute pre-bronchodilator FEV1, region, Baseline maintenance OCS therapy, exacerbations in the year prior to the study and visit, plus interaction terms for visit by Baseline and visit by treatment group.|Baseline and Week 24|mITT Population. Participants with a missing Baseline covariate value or with no observed change from Baseline at any time point were excluded from the analysis model.|||Milliliters (mL)||Standard Error|Least Squares Mean
2590655|NCT02281136|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24 hours after PDT #1|One subject did not have assessment performed|||participants|||Number
2590675|NCT02280863|Secondary|Mean Glucose Values, Fingerstick Glucose Meter Value, Adult Cohorts|Mean glucose values are reported as assessed by fingerstick glucose meter value.|Up to 10 days|Data are presented for adult cohorts only.|||mg/dL||Standard Deviation|Mean
2590638|NCT02281318|Primary|Mean Change From Baseline (BL) in St. George's Respiratory Questionnaire (SGRQ) Score at Week 24|SGRQ consisted of 50 questions (scored from 0 to 100 where 0 indicates best and 100 indicates worst health) designed to measure Quality of Life in par. with diseases of airway obstruction, measuring symptoms, impact, and activity. Questions were completed by the par. with a recall over the past 4 weeks. SGRQ Total Score was calculated by summing the pre-assigned weights of answers, dividing by the sum of the maximum weights for items in SGRQ and multiplying by 100 to get a %. Change from BL in SGRQ was calculated as value at Week 24 minus value at BL for each par. and was analyzed using mixed model repeated measures allowing for covariates of BL value, region, BL maintenance oral corticosteroid (OCS) therapy, exacerbations in the year prior to the study (as an ordinal variable), BL % predicted FEV1 and visit, plus interaction terms for visit by BL and visit by treatment group. Modified Intent-to-Treat (mITT) Population consisted of all randomized par. who received >= 1 dose of drug.|Baseline and Week 24|mITT Population. Participants with a missing Baseline covariate value or with no observed change from Baseline at any time point were excluded from the analysis model.|||Scores on a scale||Standard Error|Least Squares Mean
2590639|NCT02281136|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 4||||participants|||Number
2590640|NCT02281136|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24 hours after PDT #1|One subject did not have assessment performed|||participants|||Number
2590641|NCT02281136|Secondary|OOZING/VESICULATION/CRUSTING|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline||||participants|||Number
2590642|NCT02281136|Secondary|Scaling and Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 4||||participants|||Number
2590643|NCT02281136|Secondary|Scaling and Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24 hours after PDT #1|One subject did not have assessment performed|||participants|||Number
2590644|NCT02281136|Secondary|Scaling and Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline||||participants|||Number
2590645|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Week 4||||participants|||Number
2590646|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|24 hours after PDT #1|One subject did not have assessment performed|||participants|||Number
2590647|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 Minutes after PDT||||participants|||Number
2590648|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|During PDT||||participants|||Number
2590649|NCT02281136|Secondary|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline||||participants|||Number
2590650|NCT02281136|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 4||||participants|||Number
2590651|NCT02281136|Secondary|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24 hours after PDT #1|One subject did not have assessment performed|||participants|||Number
2590657|NCT02281136|Secondary|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline||||participants|||Number
2590658|NCT02281136|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 4||||participants|||Number
2590659|NCT02281136|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|24 hours post PDT#1|One subject did not have assessment performed|||participants|||Number
2590660|NCT02281136|Secondary|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Baseline||||participants|||Number
2590661|NCT02281136|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 4||||participants|||Number
2590662|NCT02281136|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24 hours after PDT|One subject did not have assessment performed|||participants|||Number
2590663|NCT02281136|Secondary|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline||||participants|||Number
2590664|NCT02281136|Primary|The Terminal Exponential Half-life (T1/2,z)|The terminal slope will be calculated by linear least squares regression of the log plasma concentration-time data. The terminal exponential half-life (T1/2,z) will be calculated as 0.693 divided by the absolute value of slope.|1 day|T1/2,z could not be determined in 4 subjects|||hours||Geometric Coefficient of Variation|Geometric Mean
2590665|NCT02281136|Primary|AUCt|AUCt is the area under the baseline corrected plasma concentration-time profile up to the last quantifiable/non-negative plasma concentration|0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24 hours post-dose||||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2590666|NCT02281136|Primary|Time at Which Cmax is Attained (Tmax) for ALA|Time of the maximum baseline corrected plasma concentration for ALA measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16 and 24 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value.|1 day||||hours||Full Range|Median
2590667|NCT02281136|Primary|Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA|Maximum baseline corrected plasma concentration (Cmax) for ALA over the 24 hour sampling time period. Blood samples wiere taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16 and 24 hours following study medication application.|1 day||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2590668|NCT02280863|Secondary|Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Integrated System Interface and Adolescent Cohort||Up to 10 days|Data are presented for the Adult Cohort - Integrated System Interface and the Adolescent Cohort only. Participants who completed the protocol were included in the analysis.|||percentage of readings||Standard Deviation|Mean
2590669|NCT02280863|Secondary|Percentage of Fingerstick Meter Glucose Value Tests >300 mg/dL, Adult Cohort - Medtronic Android Interface||Up to 10 days|Data are presented for the Adult Cohort - Medtronic Android Interface only|||percentage of readings||Inter-Quartile Range|Median
2590670|NCT02280863|Secondary|Percentage of Time With Sensor Glucose Values <70 mg/DL, Adolescent Cohort||Up to 10 days|Data are presented for the adolescent cohort only. Participants who completed the protocol were included in the analysis.|||percentage of time||Inter-Quartile Range|Median
2590671|NCT02280863|Secondary|Percentage of Time With Sensor Glucose Values <70 mg/DL, Adult Cohorts||Up to 10 days|Data are presented for adult cohorts only.|||percentage of time||Standard Deviation|Mean
2590672|NCT02280863|Secondary|Percentage of Fingerstick Meter Glucose Value Tests <70 mg/dL||Up to 10 days|Participants who completed the protocol were included in the analysis.|||percentage of tests||Standard Deviation|Mean
2590673|NCT02280863|Secondary|Percentage of Time Within Glucose Range of 70-180 mg/dL||Up to 10 days|Participants who completed the protocol were included in the analysis.|||percentage of time in range||Standard Deviation|Mean
2590674|NCT02280863|Secondary|Median Glucose Values, Fingerstick Glucose Meter Value, Adolescent Cohort|Median an glucose values are reported as assessed by fingerstick glucose meter value.|Up to 10 days|Data are presented for the adolescent cohort only. Participants who completed the protocol were included in the analysis.|||mg/dL||Inter-Quartile Range|Median
2590677|NCT02280863|Primary|Count of Participants With no More Than One Meter Glucose Value <50 mg/dL and no Values <40 mg/dL, no More Than Two Episodes With Meter Glucose Values Remaining >300 mg/dL for More Than 1 Hour, and no Ketonemia, Seizures, or Loss of Consciousness|"Our definition of a subject successfully participating in a cohort is:~No more than one meter glucose value <50 mg/dL and no values <40 mg/dL~No more than two episodes with meter glucose values remaining >300 mg/dL for more than 1 hour that are unrelated to an infusion set failure~No ketonemia >1.0 mmol/L, while the system is functional unless related to an intercurrent illness or infusion set failure~No seizures or loss of consciousness while system is on and functional"|Up to 10 days||||Participants|||Count of Participants
2590678|NCT02280811|Secondary|Expression of Programmed Cell Death 1 (PD-1) by Circulating E6 T-Cell Receptor (TCR) T-Cells|Presence of PD-1 on circulating lymphocytes by flow cytometry one month after treatment.|one month after treatment|One patient in group HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 did not have research blood collected at one month post infusion, and thus could not examine the cells for that patient at that time point.|||% PD-1 circulating lymphocytes||Full Range|Mean
2590679|NCT02280811|Secondary|Percentage of Cluster of Differentiation 3 (CD3+) Cells That Are E6 T-Cell Receptor Memory of Circulating T-Cells in Responders and Non-responders|Detection of E6 TCR T cells in patients peripheral blood leukocytes (PBL)/apheresis samples by flow cytometry.|One month after treatment|One patient in group HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 did not have research blood collected at one month post infusion, and thus could not examine the cells for that patient at that time point.|||percentage of cells||95% Confidence Interval|Mean
2590680|NCT02280811|Secondary|Number of Participants With a Dose Limiting Toxicity (DLT)|A dose limiting toxicity is all Grade 3 and greater toxicities with the exception of myelosuppression, defined as lymphopenia, neutropenia, decreased hemoglobin, and thrombocytopenia, due to chemotherapy preparative regimen. Aldesleukin expected toxicities as defined in Appendix 2 and 3 of the protocol. Expected chemotherapy toxicities as defined in the pharmaceutical information section. Immediate hypersensitivity reactions (excluding symptomatic bronchospasm and grade 4 hypotension) occurring within 2 hours of cell infusion (related to cell infusion) that are reversible to a grade 2 or less within 24 hours of cell administration with standard therapy. Grade 3 fever. Events that are clearly related to the patient's disease.|19 months and 7 days||||Participants|||Count of Participants
2590681|NCT02280811|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|19 months and 7 days||||Participants|||Count of Participants
2590682|NCT02280811|Primary|Duration of Response|Duration of response is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progression is at least a 20% increase in the sum of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|up to one year||||months||95% Confidence Interval|Mean
2590683|NCT02280811|Primary|Objective Tumor Response Rate (Complete or Partial Response)|Objective tumor response rate is defined as the number of participants with a complete or partial response per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|4 years||||participants|||Number
2590684|NCT02280811|Primary|Maximum Tolerated Dose (MTD)|The MTD is the highest dose at which ≤1 of 6 patients experienced a dose limiting toxicity (DLT) or the highest dose level studied if DLTs are not observed at any of the dose levels.|participants were followed for the duration of hospital stay, an average of 3 weeks||||# of cells x 10^11|||Number
2590685|NCT02280655|Primary|Brachial Artery Flow-mediated Dilation (FMD) After Fresh Red Blood Cells (RBCs) Transfusions vs. Storage-aged Red Blood Cells (saRBCs) Transfusions at 24 Hours After Transfusion|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter −24 hour diameter)/24 hour diameter × 100.|24 hours after transfusion||||percentage of brachial artery diameter||Standard Deviation|Mean
2590686|NCT02280655|Primary|Brachial Artery Flow-mediated Dilation (FMD) After Fresh Red Blood Cells (RBCs) Transfusions vs. Storage-aged Red Blood Cells (saRBCs) Transfusions at Baseline|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter − baseline diameter)/baseline diameter × 100.|Baseline||||percentage of brachial artery diameter||Standard Deviation|Mean
2590687|NCT02280499|Secondary|ASES Shoulder Score Index|The American Shoulder and Elbow Surgeon's (ASES) evaluation is used to document the improvement in pain, function and range of motion after shoulder injury. The ASES Shoulder Score Index is calculated from the ASES patient related questionnaire and ranges from 0-100 with a higher score indicating improvement in pain and function.|10Years|As per the study flow chart, 26 study participants had a 10 year follow-up visit to collect the data supporting the primary outcome measure. The ASES Shoulder Score Index was calculated for 27 participants. As the score is a patient reported outcome the score could be completed at home increasing the number of available scores.|||units on a scale||Standard Deviation|Mean
2590707|NCT02280421|Primary|Time of Peak Concentration (Tmax) of ASP2151||prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.||||h||Full Range|Median
2590688|NCT02280499|Secondary|Constant Murley Score|The Constant Murley Score is a shoulder outcome score to determine the functionality of the shoulder after the treatment of a shoulder injury. The score ranges from 0 to 100 with a higher score indicating better shoulder function.|10 Years|As per the study flow chart, 26 study participants had a 10 year follow-up visit to collect the data supporting the primary outcome measure. The Constant Murley Score was incomplete for 3 participants and therefore the number of participants analyzed is 23.|||units on a scale||Standard Deviation|Mean
2590689|NCT02280499|Primary|Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components|The long-term survival rate of the Promos™ Standard shoulder system was calculated with revision due to aseptic loosening as endpoint using a Kaplan-Meier Analysis.|up to 10 years||||Percentage survivorship||95% Confidence Interval|Number
2590690|NCT02280473|Secondary|Change From Baseline in the Schirmer Test|The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement. The eye with the lower value at baseline is used for each subject.|Baseline, Day 30|Intent-to-Treat: All randomized patients|||mm/5 min||Standard Deviation|Mean
2590691|NCT02280473|Secondary|Change From Baseline in the Combined Corneal and Conjunctival Staining Scores|The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is divided into 5 zones and the nasal and temporal conjunctiva is divided into 6 zones. The combined staining score is based on the sum of the five zones on the cornea and the six zones on the conjunctiva. Each zone is graded on a 0-5 scale (0=None; 1=trace; 2=mild; 3=moderate; 4=severe; 5=very severe), for a total score ranging from 0-55. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of staining (improvement). The eye with higher score at baseline is reported for each subject.|Baseline, Day 30|Intent-to-Treat: All randomized patients|||Scores on a Scale||Standard Deviation|Mean
2590692|NCT02280473|Secondary|Change From Baseline in Tear Break-up Time (TBUT)|TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement). The eye with shorter average TBUT at baseline is reported for each patient.|Baseline, Day 30|Intent-to-Treat: All randomized patients|||Seconds||Standard Deviation|Mean
2590693|NCT02280473|Secondary|Change From Baseline in the OSDI© Score|The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.|Baseline, Day 7|Intent-to-Treat: All randomized patients|||Scores on a Scale||Standard Deviation|Mean
2590694|NCT02280473|Primary|Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score|The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.|Baseline, Day 30|Intent-to-Treat: All randomized patients|||Scores on a Scale||Standard Deviation|Mean
2590695|NCT02280421|Other Pre-specified|Area Under the Curve (AUC) of Ciclosporin||Blood samples were taken at pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 after dosing of ciclosporin on Days 6 and 7.||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2590696|NCT02280421|Other Pre-specified|Time of Peak Concentration (Tmax) of Ciclosporin||Blood samples were taken at pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 after dosing of ciclosporin on Days 6 and 7.||||h||Full Range|Median
2590697|NCT02280421|Other Pre-specified|Peak Plasma Concentration (Cmax) of Ciclosporin||Blood samples were taken at pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 after dosing of ciclosporin on Days 6 and 7.||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2590698|NCT02280421|Other Pre-specified|Half-Life (t1/2) of AS195588-00||prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.||||h||Geometric Coefficient of Variation|Geometric Mean
2590699|NCT02280421|Other Pre-specified|Area Under the Curve (AUC) of AS195588-00||prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2590700|NCT02280421|Other Pre-specified|Time of Peak Concentration (Tmax) of AS195588-00||prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.||||h||Full Range|Median
2590701|NCT02280421|Other Pre-specified|Peak Plasma Concentration (Cmax) of ASP1955888-00||prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2590702|NCT02280421|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Refer to the result of adverse event.|Up to 31 days after the Day 7 dose of ASP2151||||participants|||Number
2590703|NCT02280421|Primary|Apparent Volume of Distribution (Vd/F) of ASP2151||prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.||||L||Standard Deviation|Mean
2590704|NCT02280421|Primary|Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma||prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.||||L/h||Standard Deviation|Mean
2590705|NCT02280421|Primary|Half-Life (t1/2) of ASP2151||prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.||||h||Geometric Coefficient of Variation|Geometric Mean
2590708|NCT02280421|Primary|Peak Plasma Concentration (Cmax) of ASP2151||prior to initial dose on Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 h after ASP2151 dosing on Day 1 and Day 7, and also 72 h after ASP2151 dosing on Day 7.||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2590709|NCT02280408|Secondary|Percentage of Participants With Viremia on Day 3 and Day 7: Vaccination 2|Blood was drawn on Days 3 and 7 to assess the presence of V920 via polymerase chain reaction (PCR) assay. The percentage of participants that were positive for V920 in serum was summarized.|Day 3 and Day 7 post vaccination 2 (Day 31 and Day 35)|All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint|||Percentage of Participants|||Number
2590710|NCT02280408|Secondary|Percentage of Participants With Viremia on Day 3 and Day 7: Vaccination 1|Blood was drawn on Days 3 and 7 to assess the presence of V920 via polymerase chain reaction (PCR) assay. The percentage of participants that were positive for V920 in serum was summarized.|Day 3 and Day 7 post vaccination 1|All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint|||Percentage of Participants|||Number
2590711|NCT02280408|Secondary|Percentage of Participants Who Seroconvert: Day 56|GMTs for Zebov-specific antibodies were determined via ELISA. Seroconversion was defined as a post-vaccination titer ≥ 200 that is also at least a 4-fold increase in titer compared to baseline.|Day 56 (28 days post vaccination 2)|All randomized participants who were vaccinated twice with V920 or placebo, had ZEBOV IgG ELISA endpoint titer results on Days 0 (baseline) and 56, and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints|||Percentage of Participants|||Number
2590712|NCT02280408|Secondary|Percentage of Participants Who Seroconvert: Day 28|GMTs for Zebov-specific antibodies were determined via ELISA. Seroconversion was defined as a post-vaccination titer ≥ 200 that is also at least a 4-fold increase in titer compared to baseline.|Day 28 (28 days post vaccination 1)|All randomized participants who were vaccinated twice with V920 or placebo, had ZEBOV IgG ELISA endpoint titer results on Days 0 (baseline) and 28, and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints|||Percentage of Participants|||Number
2590713|NCT02280408|Secondary|Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies: Day 56|Blood was drawn on Day 56 to assess the GMTs of Zaire ebolavirus neutralizing antibodies as determined by Pseudovirion neutralizing assay (PsVNA). Titers are reported for PsVNA50 values, which was derived from the reciprocal of the dilution that resulted in a 50% decrease in luciferase activity.|Day 56 (28 days post vaccination 2)|All randomized participants who were vaccinated twice with V920 or placebo, had ZEBOV IgG ELISA endpoint titer results on Days 0 (baseline) and 56, and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints.|||Titer||Standard Deviation|Geometric Mean
2590714|NCT02280408|Secondary|Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies: Day 28|Blood was drawn on Day 28 to assess the GMTs of Zaire ebolavirus neutralizing antibodies as determined by Pseudovirion neutralizing assay (PsVNA). Titers are reported for PsVNA50 values, which was derived from the reciprocal of the dilution that resulted in a 50% decrease in luciferase activity.|Day 28 (28 days post vaccination 1)|All randomized participants who were vaccinated twice with V920 or placebo, had ZEBOV IgG ELISA endpoint titer results on Days 0 (baseline) and 28, and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints.|||Titer||Standard Deviation|Geometric Mean
2590715|NCT02280408|Secondary|Geometric Mean Titers of ZEBOV-specific IgG Antibodies: Day 56|Blood was drawn on Day 56 to assess the GMTs of ZEBOV-specific IgG antibodies as determined by Enzyme-linked immunosorbent assay (ELISA).|Day 56 (28 days post vaccination 2)|All randomized participants who were vaccinated twice with V920 or placebo, had ZEBOV IgG ELISA endpoint titer results on Days 0 (baseline) and 56, and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints.|||ELISA Units/mL||Standard Deviation|Geometric Mean
2590716|NCT02280408|Secondary|Geometric Mean Titers of Zaire Ebolavirus-(ZEBOV)-Specific Immunoglobin G (IgG) Antibodies: Day 28|Blood was drawn on Day 28 to assess the GMTs of ZEBOV-specific IgG antibodies as determined by enzyme-linked immunosorbent assay (ELISA).|Day 28|All randomized participants who were vaccinated twice with V920 or placebo, had ZEBOV IgG ELISA endpoint titer results on Days 0 (baseline) and 28, and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints.|||ELISA Units/mL||Standard Deviation|Geometric Mean
2590717|NCT02280408|Primary|Percentage of Participants With Early Discontinuation of Vaccination|The percentage of participants that had vaccination discontinued for any reason was summarized.|Up to Day 28|All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint|||Percentage of participants|||Number
2590718|NCT02280408|Primary|Percentage of Participants With 1 or More Solicited Local Injection-site AE by Severity: Vaccination 2|"A solicited AE was a predetermined specific event. The solicited local AEs for this study were the following: Local reactogenicity signs and symptoms include pain, erythema (redness), and induration (swelling). All AEs were assessed for severity by the investigator according to the Food and Drug Administration(FDA's) Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials and were classified into 4 categories: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3) and Potentially Life-Threatening (Grade 4). The percentage of participants that experienced at least 1 solicited local AE was summarized by grade."|Up to 14 days post vaccination 2 (Day 29 up to Day 42)|All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint|||Percentage of participants|||Number
2590719|NCT02280408|Primary|Percentage of Participants With 1 or More Solicited Local Injection-site AE by Severity: Vaccination 1|"A solicited AE was a predetermined specific event. The solicited local AEs for this study were the following: Local reactogenicity signs and symptoms include pain, erythema (redness), and induration (swelling). All AEs were assessed for severity by the investigator according to the Food and Drug Administration(FDA's) Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials and were classified into 4 categories: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3) and Potentially Life-Threatening (Grade 4). The percentage of participants that experienced at least 1 solicited local AE was summarized by grade."|Up to 14 days post vaccination 1 (Day 1 to Day 14)|All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint|||Percentage of participants|||Number
2590720|NCT02280408|Primary|Percentage of Participants With One or More Serious Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. An SAE is an AE that results in death, is life-threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. The percentage of participants that experienced 1 or more SAEs was summarized.|Up to Day 56 (Day 1 up to Day 56)|All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint|||Percentage of participants|||Number
2590721|NCT02280408|Primary|Percentage of Participants With 1 or More Solicited Systemic AE by Severity: Vaccination 2|"A solicited AE was a predetermined specific event. The solicited systemic AEs for this study were the following: redness, swelling, or pain at site of injection, subjective and objective fever, chills, sweats, myalgia, arthralgia, fatigue, headache and gastrointestinal symptoms (nausea, vomiting, abdominal pain, and/or diarrhea). All AEs were assessed for severity by the investigator according to the Food and Drug Administration(FDA's) Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials and were classified into 4 categories: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3) and Potentially Life-Threatening (Grade 4). The percentage of participants that experienced at least 1 solicited systemic AE were summarized by grade."|Up to 14 days post vaccination 2 (Day 29 up to Day 42)|All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint.|||Percentage of Participants|||Number
2590722|NCT02280408|Primary|Percentage of Participants With 1 or More Solicited Systemic Adverse Event (AE) by Severity: Vaccination 1|"A solicited AE was a predetermined specific event. The solicited systemic AEs for this study were the following: redness, swelling, or pain at site of injection, subjective and objective fever, chills, sweats, myalgia, arthralgia, fatigue, headache and gastrointestinal symptoms (nausea, vomiting, abdominal pain, and/or diarrhea). All AEs were assessed for severity by the investigator according to the Food and Drug Administration(FDA's) Guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials and were classified into 4 categories: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3) and Potentially Life-Threatening (Grade 4). The percentage of participants that experienced at least 1 solicited systemic AE were summarized by grade."|Up to 14 days post vaccination 1 (From Day 1 up to Day 14)|All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint.|||Percentage of Participants|||Number
2590723|NCT02280408|Primary|Percentage of Participants With 1 or More Unsolicited AE : Vaccination 2|An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. An unsolicited AE was an AE other than those specifically designated local or systemic. The percentage of participants that experienced at least 1 unsolicited AE was summarized.|Up to 28 days post vaccination 2 (From Day 29 to Day 56)|All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint|||Percentage of participants|||Number
2590724|NCT02280408|Primary|Percentage of Participants With 1 or More Unsolicited AE : Vaccination 1|An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. An unsolicited AE was an AE other than those specifically designated local or systemic. The percentage of participants that experienced at least 1 unsolicited AE was summarized.|Up to 28 days post vaccination 1 (From Day 1 up to Day 28)|All randomized participants who received at least 1 vaccination with V920 or placebo and had follow-up data for endpoint|||Percentage of participants|||Number
2590725|NCT02280304|Post-Hoc|Relating Extent of Participation in the Community (as Measured by the CRIS-CAT) Prior to Therapy to the Functional Connectivity of the Right Hippocampus After Therapy.|The goal was to see if extent of participation in the community prior to therapy could predict the degree of functional connectivity between regions whose connectivity has been suggested to be part of a context processing network, disrupted during PTSD. The hippocampus was investigated because it is one of these regions. (The MPFC and thalamus are others.)|12 weeks|Groups were combined to increase range of the sample size and to examine the general effect of therapy. Subjects (n=16; 9 IRV and 7 ES) were those who had both a post-therapy scan (regardless of therapy, IRV or ES) and CRIS-CAT scores prior to therapy.|||beta|||Number
2590726|NCT02280304|Post-Hoc|Test of Additional Limbic Seeds (Hippocampal and Parahippocampal Gyri)|Within-group Post vs. Pre t-tests were done for each group with left and right hippocampal and parahippocampal gyrus (PHG) as seeds. Below are mean Fisher-transformed z scores and respective standard deviations of the Pearson's product correlation coefficients between the seed and cluster for each group. Positive mean z-scores scores reflect positive correlations between the seed and the cluster, and negative mean z-scores reflect negative correlations between the seed and the cluster. L IPL = left intraparietal lobule; VMPFC=ventromedial prefrontal cortex|12 weeks|The sample sizes here differ from those reported for other measures because these are the numbers of subjects who had MRI available and with acceptable quality assessment (i.e., not excluded because of excessive motion or sleepiness) for both time periods. Note that the sample sizes are identical to those reported in the secondary outcome section.|||z-scores||Standard Deviation|Mean
2590727|NCT02280304|Other Pre-specified|Patient Health Questionnaire-9 (PHQ-9) Patient Depression Questionnaire Difference Score|The Patient Health Questionnaire-9 (PHQ-9) measure is a self-report measure of depression symptoms. Scores fall in the range 0-27; higher scores indicate worse outcome. This difference score denotes improvement in symptoms of depression. It was calculated by subtracting the value of PHQ-9 scores at baseline minus PHQ-9 scores scores at week 12.|12 weeks, baseline|The sample sizes here differ from those reported for other measures because these are the numbers of subjects who had PHQ-9 forms completed at both time periods.|||Score on a scale||Full Range|Mean
2590728|NCT02280304|Other Pre-specified|PTSD Checklist 5 (PCL5) Difference Score|The PTSD Checklist 5 (PCL5) is a measure of PTSD symptoms based on DSM-V. The scores fall in the range 0-80; higher scores indicate worse outcome. We calculated the PTSD Checklist 5 (PCL5) difference score by subtracting the value at baseline minus the value at week 12. In this case higher scores represent a reduction in PTSD symptoms.|12 weeks, baseline|The sample sizes here differ from those reported for other measures because these are the numbers of subjects who had completed PCL-5 at both time periods.|||Score on a scale||Full Range|Mean
2590729|NCT02280304|Secondary|Community Reintegration in Service Members (CRIS)|Scores at baseline and 12 weeks in responses to the computerized version of the Community Reintegration in Service Members (CRIS-CAT) questionnaire in patients following meditation or control. There are three subscales: Extent of Participation (range 24-90), Perceived Limitations (range 33-99), and Satisfaction (range 34-91). Higher is better.|12 weeks and baseline|The sample sizes here differ from those reported for other measures because these are the numbers of subjects who had completed the CRIS at both time periods.|||score on a scale||Standard Deviation|Mean
2590730|NCT02280304|Secondary|Number of Participants With Significant Changes in Resting State Functional Connectivity Following Meditation or Control|Functional connectivity was measured between the Default Mode Network (DMN) and lateral prefrontal cortex (LPFC), and between the amygdala and anterior cingulate. There were four seeds for the DMN (MPFC, PCC, left lateral parietal, right lateral parietal), and two seeds for the amygdala (right and left). Correlation coefficients representing the degree of connectivity between hypothesized regions were Fisher transformed. An a priori threshold of p<.001 at the voxel level and p<.05, FDR corrected for multiple comparisons across the whole brain, at the cluster level were used to determine significant connectivity.|12 weeks and baseline|The sample sizes here differ from those reported for other measures because these are the numbers of subjects who had MRI available and with acceptable quality assessment (i.e., not excluded because of excessive motion or sleepiness) for both time periods.|||Participants|||Count of Participants
2590731|NCT02280304|Primary|Clinician-Administered PTSD Scale (CAPS5)|Changes in responses in the CAPS5 will be measured in patients following IRV meditation+mantra or ES education control.|12 weeks|One CAPS rater did not meet study criteria for expert CAPS administration; as a result, the CAPS data are not considered valid.||||||
2590732|NCT02280291|Secondary|Disability of the Arm, Shoulder and Hand (DASH) Score|The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.|2 Weeks, 6 Weeks|Data was not collected for the Ankle SSB and Ankle OnQ arms, as the DASH scale is upper extremity-specific (including only arm, shoulder, and hand disabilities).|||score on a scale||Standard Deviation|Mean
2590733|NCT02280291|Primary|Change in Score on Visual Analog Scale (VAS)|"The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 (no pain) and 10 (worst pain)."|2 weeks, 6 weeks|Some of the number of participants analyzed differs from the overall number analyzed because some participants were lost to follow up.|||score on a scale||Standard Deviation|Mean
2590734|NCT02280226|Primary|Mean Blood Flow Measurement Under Apnea Using MRI|Blood flow pattern in subjects undergoing maximum apnea.|Every minute under apnea (from 0 up to 9 minutes and rest) depending on personal best with a mean of 5 measurements||||ml/s||Standard Deviation|Mean
2590735|NCT02280226|Primary|Cardiac Function: Duration of Apnea|Alteration of cardiac function in subjects undergoing maximum apnea.|every minute under apnea (from 0 up to 9 minutes and rest) depending on personal best with a mean of 5 measurements||||sec||Standard Deviation|Mean
2590736|NCT02280200|Primary|Change in SF-36 MCS|Change in Medical Outcomes Study Short Form 36-item questionnaire, Mental Component Summary The SF-36 has eight scaled subscores (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health). These subscores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.|12 weeks||||Scale units||Standard Deviation|Mean
2590737|NCT02280200|Primary|Change in SF-36 PCS|Change in Medical Outcomes Study Short Form 36-item questionnaire, Physical Component Summary The SF-36 has eight scaled subscores (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health). These subscores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability.|12 weeks||||Scale units||Standard Deviation|Mean
2590738|NCT02280200|Primary|Change in WIQ Stair-Climbing Subscore|In the Walking Impairment Questionnaire stair-climbing subcategory, participants are asked to rate the degree of difficulty climbing a specified number of stair flights, ranging from 1 to 3 stair flights, on a graded scale of 0 to 4. A score of 0 indicates the inability to climb the flights specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).|12 weeks||||percent of score||Standard Deviation|Mean
2590739|NCT02280200|Primary|Change in WIQ Speed Subscore|In the Walking Impairment Questionnaire speed subcategory, participants are asked to rate the degree of difficulty walking one block at specific speeds, ranging from walking slowly to jogging, on a scale from 0 to 4. A score of 0 indicates the inability to walk the distance specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).|12 weeks||||Scale units||Standard Deviation|Mean
2590766|NCT02280096|Primary|The Brief Repeatable Battery of Rao|Neuropsychological tests to assess: verbal fluency. Participants have to say as many words as possible from a category in a given time 60 Sec (F, A, S) Max score 72 and min score 19 words. Higher scores indicate a better cognitive performance.|10-15 minutes|Word List Generation (3 trials/60 sec)|||Correct words||Standard Deviation|Mean
2590740|NCT02280200|Primary|Change in WIQ Distance Subscore|In the Walking Impairment Questionnaire distance subcategory, participants are asked to rate the degree of difficulty walking specific distances on a scale from 0 to 4. A score of 0 indicates the inability to walk the distance specified by the question while a score of 4 represents no difficulty. The graded sub-score is multiplied by a pre-specified weight for each sub-category: distance, speed, and number of flights of stairs. The products of these subscores are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (inability to perform item) to 100 (no difficulty in performing item).|12 weeks||||Scale units||Standard Deviation|Mean
2590741|NCT02280187|Secondary|Fusion Rates in Subgroups|Fusion rates in subgroup (Smokers, non-smokers, Patients with and without diabetes) are reported.|12 months||||percentage of participants|||Number
2590742|NCT02280187|Secondary|Fusion Status at the Last Assessment Performed by 12 Months|According to the study protocol, fusion status was determined to be either success or no success based on the images. If fusion failed at 1 level, the fusion was considered to be failed for the patient. The fusion rate at the last assessment is reported.|12 months|The subjects with the image that unable to determine fusion status and the assessment not done” were not taken into account.|||percentage of participants|||Number
2590743|NCT02280187|Secondary|The Number of Unplanned Secondary Spine Interventions in Subgroups|The number of unplanned secondary spine interventions is reported by subgroups (smoker, non-smoker, diabetics, and non-diabetics).|12 months||||participants|||Number
2590744|NCT02280187|Secondary|The Number of Subjects Having Secondary Spine Surgical Intervention|The number of subjects who had secondary spine surgical intervention at index level treated with InductOs and other level (either never treated or treated without InductOs) through 12 months is reported.|12 months||||participants|||Number
2590745|NCT02280187|Secondary|AEI Categorisation|The number of AEIs is presented by the categories predefined in the study protocol. The AEI MedDRA coded terms are presented in Section of serious adverse event.|12 months||||events|adverse event||Number
2590746|NCT02280187|Secondary|The Number of Adverse Events of Interest|An adverse event was considered an event of interest (AEI) if an adverse event was considered important to follow. These included reactions described in the EU product label, events monitored in the EU Risk Management Plan, events that were considered possible related to the treatment by the investigator, and events that had serious health consequences for patients (e.g. hospitalization).|12 months||||events|||Number
2590747|NCT02280187|Primary|Instrumentations Used for Stabilization|The number of spine levels using instrumentations for stabilization is presented by types of instrumentations.|during surgery|The total levels in the summary are higher than total amount of levels because multiple answers are possible.|||spine level|Spine level||Number
2590748|NCT02280187|Primary|Supplemental Fixation|The number of spine levels on which supplemental fixation was performed is presented by approaches of stabilization (anterior or posterior stabilization).|During surgery|The total levels across all the rows are higher than total number of levels analyzed because some levels may be represented in more than one rows.|||spine level|Spine level||Number
2590749|NCT02280187|Primary|Placement of the Matrix Wetted With InductOs|The placement of the matrix was classified as posterior lateral or interbody space (Inside the cage, between the cages or outside the cage) or any other placement specified. The number of spine levels is presented by placement of the matrix.|During surgery|The total levels across all the rows are higher than total number of levels analyzed because multiple answers are possible.|||spine level|Spine level||Number
2590750|NCT02280187|Primary|The Interbody Device Brand/Generic Names Used With InductOs|The number of spine levels with InductOs is presented by interbody brand/generic names.|during surgery||||spine level|Spine level||Number
2590751|NCT02280187|Primary|Primary Surgical Approaches Used for Implantation of InductOs|The surgical approaches for implanting InductOs are classified as anterior lumbar interbody fusion (ALIF), posterior lumbar interbody fusion (PLIF), translateral lumbar interbody fusion (TLIF), lateral lumber interbody fusion (LLIF, including DLIF and XLIF), posterolateral fusion (PLF). The number of spine levels by surgical approaches is presented.|During surgery||||spine level|Spine level||Number
2590752|NCT02280187|Primary|Spine Levels Treated|The number of spine levels from the occiput to S1 is presented.|During surgery||||spine level|Spine level||Number
2590753|NCT02280187|Primary|The Primary Diagnostic Indication for InductOs Use|The primary diagnostic indications, which patients were treated with InductOs during spine fusion surgery in France, are presented.|Baseline||||percentage of participants|||Number
2590754|NCT02280122|Primary|Percentage of True Positive/Negative aMMP-8 Tests of All Periodontitis Patients (Sensitivity/Specificity)|First off all patients rinsed with tap water for 30 seconds. Then they spat out the water and waited for 1 min. Now patients rinsed with 5ml of purified water for 30 seconds and spat this sample back into the test cup. Approximately 2 ml of the sampled saliva was now sampled with a syringe. After a filter was put onto the syringe 3 drops of the saliva were pressed through the filter into the ELISA kit. After 5 to 10 min the result was read from the test kit [21]. If both the control and test stripes were visible the respective test was positive (i.e. ≥ 25 ng aMMP 8 per ml). The clinical examiner (SIB) judged the results by simple visual inspection. Already a faint test stripe was judged as positive test. All test results were photographed with 2fold magnification. All images of the test were then evaluated by a second examiner (PE) who was blinded for the clinical diagnoses.|5 minutes||||percentage of true cases (sens./spec.)||95% Confidence Interval|Number
2590755|NCT02280096|Secondary|Number of Participants With Abnormal Studies|Safety surveillance will be done every two weeks from the beginning of the study, intentionally searching for adverse events (AE). EEG (Diffuse or focal cerebral dysfunction through demonstration of background slowing or presence of epileptiform activity assessed by a neurophysiologist) and laboratory tests (Presence of values higher of the normal value established by local laboratory and related to the administration of treatments), blood and urine samples: creatinine, blood urea nitrogen, total cholesterol, triglycerides, total direct, and indirect bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, creatinine kinase, lactic acid dehydrogenase, amylase and lipase. A complete blood cell count with differentials and a routine urinalysis and urine culture also obtained at each visit, will be done before the patients take 40, 50 and 60 mg/day. The number of participants with abnormal studies were reported.|22 weeks||||Participants|||Count of Participants
2590756|NCT02280096|Secondary|Walk|Timed 25 Foot Walk Test (T25-FW). The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. TIME LIMIT PER TRIAL (2) 3 minutes (180 seconds) per trial.|5-10 minutes||||seconds||Standard Deviation|Mean
2590757|NCT02280096|Secondary|Fatigue|The Fatigue Severity Scale (FSS) is one of the most frequently used inventories for measuring fatigue in people with chronic illnesses. The FSS questionnaire is comprised of nine statements inquiring about the examinee's sleep habits over the preceding week. Ratings are on a 7-point Likert scale, where higher scores indicate how strongly the patient agrees with the nine statements.Scale. Scoring using a bimodal response system or a Likert score with weights assigned to each response choice. Likert or bimodal rating scales with 4 response options. For the Likert Scale: better than usual= 0, no more than usual= 1, worse than usual= 2, much worse than usual= 3. For the bimodal scale: better than usual= 0, no more than usual= 0, worse than usual= 1, much worse than usual= 1. Sum all items for a total score. Score range. Range is 0 -11 for bimodal response format. Interpretation of scores. Higher score indicates more fatigue. Self report scale|10 minutes||||score on a scale||Standard Deviation|Mean
2590758|NCT02280096|Secondary|Improved Physical Capacity|The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist. The first levels 1.0 to 4.5 refers to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refers to the loss of ambulatory ability. It also provides eight subscale measurements called Functional System (FS) scores. The levels of function within each category refer to the eight FS affected by MS: The FS are scored on a scale of 0 (low level of problems) to 5 (high level of problems) to best reflect the level of disability observed clinically.|15-20 minutes||||score on a scale||Standard Deviation|Mean
2590759|NCT02280096|Primary|Tower Of London (TOL). Execution Time and Problem-solving Time|Measures higher-order problem-solving ability. The information it provides is not only useful when assessing frontal lobe damage, but also when evaluating attention disorders and executive functioning difficulties. The administrator arranges red, green, and blue beads on a peg board to match the configuration in the diagram. The patient is asked to replicate the configuration on a second peg board. Scores are calculated for Total Execution Time (since the patient performs the first move until he ends the test), Total Problem-Solving Time (the sum of planning and execution times). Total execution time higher scores indicate a worse outcome (min= 0-78, max=564+ seconds), Total problem-solving time higher scores indicate a worse outcome (min= 0-56, max=500+ seconds).|25-30 minutes||||seconds||Standard Deviation|Mean
2590760|NCT02280096|Primary|Tower Of London (TOL). Total Moves and Total Correct Moves|Measures higher order problem-solving ability. The information it provides is not only useful when assessing frontal lobe damage, but also when evaluating attention disorders and executive functioning difficulties. The administrator arranges red, green, and blue beads on a peg board to match the configuration in the diagram. The patient is asked to replicate the configuration on a second peg board. Scores are calculated for Total Correct Moves and Total Moves. Total moves: higher scores indicate a worse cognitive performance (min= 0, max=58+); Total correct higher scores indicate a better cognitive performance (min=0, max=10).|25-30 minutes||||score on a scale||Standard Deviation|Mean
2590761|NCT02280096|Primary|Color Trails Test (CTT)|Measure sustained attention. The CTT uses numbered coloured circles and universal sign language symbols. The circles are printed with vivid pink or yellow backgrounds that are perceptible to colourblind individuals. For the Colour Trails 1 trial, the respondent uses a pencil to rapidly connect circles numbered 1 through 25 in sequence. Less time indicates better performance (min=10, max= 240).|5-8 minutes|Color Trails Test 1. Execution time|||units on a scale (seconds)||Standard Deviation|Mean
2590762|NCT02280096|Primary|Wisconsin Card Sorting Test (WCST)|"Is used primarily to assess perseveration and abstract thinking, allows the clinician to assess the following 'frontal' lobe functions: strategic planning, organised searching, utilising environmental feedback to shift cognitive sets, directing behaviour toward achieving a goal. WCST measures abstract reasoning and ability to alter problem solving strategies. Patients are given 128 response cards and 4 stimulus cards and asked to match each stimulus card to 1 pile of response cards. The patient is not told how to match the cards, only right or wrong to each placement. The examiner may change matching rules during the test. Perseveration errors occur when subject repeats the same error no matter how many times they are told the placement is wrong. Higher scores indicate a worse cognitive performance (min=0-3, max=58-126)"|10-15 minutes||||score on a scale||Standard Deviation|Mean
2590763|NCT02280096|Primary|Five Digit Test (FDT). Processing Speed|Processing speed information (which includes reading, count, and alternation speed). Cards with a different number of stimuli are shown to the patient, who has to read, count, and respond to a change of instructions (alternation). Reading speed (min 12, max 31+ seconds), counting speed (min 14, max 28+ seconds), and alternation speed (min 26, max 56+ seconds) are recorded. Less speed corresponds to a better outcome.|8-10 min||||seconds||Standard Deviation|Mean
2590764|NCT02280096|Primary|Rey-Osterrieth Complex Figure Test (ROCF)|The purpose of this test is to assess visual-spatial constructional ability and visual memory. The time required to copy the drawing is recorded. Less time indicates a better performance and more time indicates a worse outcome (min score 60 and max score 300 seconds).|10-15 minutes||||units on a scale (seconds)||Standard Deviation|Mean
2590765|NCT02280096|Primary|Integrated Program of Neuropsychological Exploration Test Barcelona|Integrated Program of Neuropsychological Exploration Test Barcelona: Digit Span Forward (DSF), (attention spam and improved scoring metrics significantly enhance the precision of DSF assessments of short-term verbal memory). Digit sequences are presented beginning with a length of two digits and two trials are presented at each increasing list length. Max score 8 and min score 0 digits. Higher scores indicate a better cognitive performance.|7-10 min|Attention spam.|||correct numbers recalled||Standard Deviation|Mean
2590767|NCT02280044|Post-Hoc|Recrudescent Events|Recovered C jejuni from fecal specimen on follow-up after an apparent cure|84 Days||||Participants|||Count of Participants
2590768|NCT02280044|Primary|Campylobacteriosis|"A clinical illness meeting at least one of the following patterns:~Moderate to severe diarrhea.~Fever (present on at least 2 occasions, at least 20 minutes apart) without diarrhea, plus an associated symptom (nausea, vomiting, abdominal cramps, tenesmus, or gross blood in ≥ 2 stools); with consideration of potential alternative diagnosis per clinical investigator based on illness time course and associated symptoms."|120 hours after challenge||||Participants|||Count of Participants
2590769|NCT02279862|Secondary|Prostate Specific Antigen Response Rate|PSA response rate was defined as the proportion of participants with a 50% or greater decrease from baseline to the lowest post-baseline PSA result (confirmed 3 weeks later) for each randomized arm. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants showing PSA response is shown.|From baseline to PSA response (assessed up to December 2016, approximately 48 months)|All randomized participants|||Participants|||Count of Participants
2590770|NCT02279862|Secondary|Time to Pain Progression|Pain progression was defined as an increase in BPI-SF pain Item #3 score of >= 2 point from baseline maintained over 2 consecutive periods. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment, and presented efficacy results are based on limited data. The number of participants with reported pain progression is shown.|From randomization until pain progression (assessed up to December 2016, approximately 24 months)|All randomized participants|||Participants|||Count of Participants
2590771|NCT02279862|Secondary|Prostate Specific Antigen Progression-free Survival (PSA PFS)|Prostate specific antigen progression-free survival (PSA PFS) was defined as the time from randomization to the earliest date of PSA progression or death, whichever occurs earlier. Participants who did not progress or die were censored at the last PSA assessment date. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants with reported PSA progression is shown.|From randomization to the earliest date of PSA progression or death, whichever comes earlier (assessed up to December 2016, approximately 24 months)|All randomized participants|||Participants|||Count of Participants
2590772|NCT02279862|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored at the last date the participant was known to be alive. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The total number of reported deaths is shown.|From randomization to death from any cause (assessed up to December 2016, approximately 24 months)|All randomized participants|||Participants|||Count of Participants
2590773|NCT02279862|Primary|Radiographic Progression-free Survival (rPFS)|rPFS was defined as the time from the date of randomization until the date of disease progression based on radiographic evidence and/or death from any cause, whichever occurs first. Radiographic disease progression is defined as: Confirmed bone disease progression according to criteria adapted from the Prostate Cancer Clinical Trials Working Group 2 (PCWG2), OR Non-bone disease progression according to the modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants with reported radiographic progression is shown.|From date of randomization until disease progression or death (assessed up to December 2016, approximately 24 months)|All randomized participants|||Participants|||Count of Participants
2590774|NCT02279862|Secondary|Number of Participants Who Experienced Immune-related Adverse Events (irAEs)|The total number of participants with immune-related adverse events of any grade is reported for each arm.|From first dose of ipilimumab to last dose plus 90 days|All treated participants|||Participants|||Count of Participants
2590775|NCT02279732|Secondary|Progression-free Survival (PFS) Among All Randomized Particiapants Who Received at Least One Dose of Blinded Study Therapy Using Modified World Health Organization (mWHO) Criteria|PFS is defined as the time between the date of randomization and the date of progression per mWHO criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria was considered to have progressed on the date of death. For those participants who remained alive and had not progressed, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.|Approximately 43 months post study start|All participants who were randomized and received at least 1 dose of blinded study therapy.The sponsor decided to discontinue enrollment and randomization in the study CA184-153 effective 25-Sep-2015. As a result, no data was collected for this secondary endpoint|||months||95% Confidence Interval|Median
2590776|NCT02279732|Secondary|Overall Survival of All Randomized Participants|OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.|Approximately 43 months post study start|All participants who were randomized to a treatment arm. The sponsor decided to discontinue enrollment and randomization in the study CA184-153 effective 25-Sep-2015. As a result, no data was collected for this secondary endpoint|||months||95% Confidence Interval|Median
2590777|NCT02279732|Primary|Overall Survival (OS) of All Randomized Participants Who Received at Least One Dose of Blinded Study Therapy|OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.|Approximately 43 months post study start|All participants who were randomized and received at least 1 dose of blinded study therapy.The sponsor decided to discontinue enrollment and randomization in the study CA184-153 effective 25-Sep-2015. As a result, no data was collected for this primary endpoint|||months||95% Confidence Interval|Median
2590778|NCT02279667|Primary|AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity|AUC0-∞ - the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity of BIA 2-093 metabolite: BIA 2-005|Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose||||ng*h/mL||Standard Deviation|Mean
2590779|NCT02279667|Primary|AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time|AUC0-t - the Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time of BIA 2-093 metabolite: BIA 2-005|Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose||||ng*h/mL||Standard Deviation|Mean
2590780|NCT02279667|Primary|Tmax - the Time of Occurrence of Cmax|Tmax - the Time of Occurrence of maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005|Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose||||hours||Full Range|Median
2590781|NCT02279667|Primary|Cmax - the Maximum Plasma Concentration|Cmax - the maximum plasma concentration of BIA 2-093 metabolite: BIA 2-005|Blood samples for PK assays: pre-dose, 30, 60 and 90 minutes, and 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose||||ng/mL||Standard Deviation|Mean
2590782|NCT02279641|Primary|Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)|Ae0-24 of RDEA3170 Alone and In Combination with Allopurinol|22 days||||ug||95% Confidence Interval|Geometric Mean
2590783|NCT02279641|Primary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)|AUC last of RDEA3170 Alone and In Combination with Allopurinol|22 days||||ng·hr/mL||95% Confidence Interval|Geometric Mean
2590784|NCT02279641|Primary|Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)|AUC 0-24 of RDEA3170 Alone and In Combination with Allopurinol|22 days||||μg*hr/mL||95% Confidence Interval|Geometric Mean
2590785|NCT02279641|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax of RDEA3170 Alone and In Combination with Allopurinol|22 days||||ng/mL||95% Confidence Interval|Geometric Mean
2590786|NCT02279641|Secondary|Incidence of Treatment-Emergent Adverse Events||22 days||||Number of participants|||Number
2590787|NCT02279641|Primary|Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine||22 days||||Percentage (%)||Standard Error|Mean
2590788|NCT02279641|Primary|Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24)|CLR0-24 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination|22 days||||mL/min||95% Confidence Interval|Geometric Mean
2590789|NCT02279641|Primary|Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24)|Ae0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170|22 days||||mg||95% Confidence Interval|Geometric Mean
2590790|NCT02279641|Primary|Apparent Terminal Half-life (t1/2)|t1/2 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination|22 days||||hr||95% Confidence Interval|Geometric Mean
2590791|NCT02279641|Primary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)|AUC last of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170|22 days||||μg·hr/mL||95% Confidence Interval|Geometric Mean
2590792|NCT02279641|Primary|Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)|AUC 0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170|22 days||||μg·hr/mL||95% Confidence Interval|Geometric Mean
2590793|NCT02279641|Primary|Time of Occurrence of Maximum Observed Concentration (Tmax)|Tmax of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination|22 days||||hr||Full Range|Median
2590794|NCT02279641|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170|22 days||||μg/mL||95% Confidence Interval|Geometric Mean
2590795|NCT02279498|Secondary|Coefficient of Nitrogen Absorption (CNA)|Change from baseline in coefficient of nitrogen absorption|Baseline, 7 weeks|Analysis population evaluates observed case data without multiple imputation for missing values|||percent of nitrogen ingested||Standard Deviation|Mean
2590796|NCT02279498|Secondary|Coefficient of Fat Absorption (CFA)|Change from baseline in coefficient of fat absorption|Baseline, 7 weeks|Analysis population evaluates observed case data without multiple imputation for missing values|||fat absorbed as % of fat ingested||Standard Deviation|Mean
2590797|NCT02279498|Primary|Treatment Difference in Coefficient of Fat Absorption (CFA) Change From Baseline|The primary endpoint evaluates the difference between treatment arms in change from baseline in coefficient of fat absorption (CFA). As such, descriptive statistics for individual treatment arms are not provided in this measure, but are reported in the secondary endpoints|Baseline, 7 weeks|Analysis population evaluates all subjects who received at least one dose of study drug. Missing Visit 7 CFA values were multiply imputed using baseline CFA, baseline BMI, sex, age, acid suppression usage, and region.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2590798|NCT02279420|Primary|Mean Percent Total Body Weight Loss|Percent total body weight loss calculated through 12 months post procedure|1 Year||||percentage of TBW||Standard Deviation|Mean
2590799|NCT02279407|Secondary|Change From Baseline to Week 12 in % Liver Fat (Comparison Between Active Treatment Groups)|To evaluate the relative efficacy of the combination of Epanova and dapagliflozin versus Epanova alone and dapagliflozin alone with respect to reduction in % liver fat at the end of 12 weeks of double-blind treatment. Treatment effect in liver fat reduction (%) was assessed using a mixed linear model with the change from baseline on logarithmic scale as response variable and the logarithm of the baseline value as covariate, treatment as fixed effect, and center as random effect. The treatment effect was then back-transformed to original scale as Geometric mean ratio and presented as percentage change from baseline.|12 weeks|The Full Analysis Set included all randomized patients, regardless of whether they took trial medication or not. In this set, patients were analyzed according to their randomized treatment assignment.|||ratio of % liver fat||95% Confidence Interval|Geometric Mean
2590800|NCT02279407|Primary|Change From Baseline to Week 12 in % Liver Fat as Assessed by MRI (Comparison Versus Placebo)|To evaluate the efficacy of the combination therapy (Epanova + Dapagliflozin) when compared to placebo with respect to reduction in liver fat content (%) at the end of 12 weeks of double-blinded treatment. Treatment effect in liver fat reduction (%) was assessed using a mixed linear model with the change from baseline on logarithmic scale as response variable and the logarithm of the baseline value as covariate, treatment as fixed effect, and center as random effect. The treatment effect was then back-transformed to original scale as Geometric mean ratio and presented as percentage change from baseline.|12 weeks|The Full Analysis Set included all randomized patients, regardless of whether they took trial medication or not. In this set, patients were analyzed according to their randomized treatment assignment.|||ratio of % liver fat||95% Confidence Interval|Geometric Mean
2590801|NCT02279173|Secondary|Percentage of Participants Who Developed Increased Reticulin|"The percentage of participants with increased reticulin as evidenced by silver staining and defined as any increase from baseline in the modified Bauermeister grade:~Grade 0: No reticulin fibers demonstrable~Grade 1: Occasional fine individual fibers and foci of a fine fiber network Grade 2: Fine fiber network throughout most of the section; no coarse fibers~Grade 3: Diffuse fiber network with scattered thick coarse fibers but no mature collagen (negative to trichrome staining)~Grade 4: Diffuse, often course fiber network with areas of collagenization (positive trichrome staining)~Participants without an evaluable baseline result were assumed to have a baseline modified Bauermeister score of 0."|Baseline, year 1 (Cohort 1) and year 2 (Cohort 2)|The bone marrow analysis set includes participants who received at least 1 dose of romiplostim, who were recruited within the protocol supplement for the EU, Switzerland and Turkey and who had at least 1 bone marrow biopsy during the study after initiation of study treatment. Participants with available core biopsy results are included.|||percentage of participants||95% Confidence Interval|Number
2590802|NCT02279173|Primary|Percentage of Participants Who Developed Bone Marrow Abnormalities|The percentage of participants with bone marrow abnormalities (eg, myelodysplastic syndrome, monosomy 7) based on analysis of bone marrow biopsy and aspirate samples using cytogenetics and fluorescence in situ hybridization.|Year 1 (Cohort 1) and year 2 (Cohort 2)|Bone marrow analysis set participants with an on-study bone marrow abnormality assessment|||percentage of participants||95% Confidence Interval|Number
2590803|NCT02279173|Primary|Percentage of Participants With Increased Modified Bauermeister Grade|"The percentage of participants with an increased modified Bauermeister grade defined as an increase by ≥ 2 severity grades or an increase to grade 4 (i.e., grade 0 to 2-4, grade 1 to 3-4, grade 2 to 4, or grade 3 to 4 over baseline). The modified Bauermeister grading scale:~Grade 0: No reticulin fibers demonstrable~Grade 1: Occasional fine individual fibers and foci of a fine fiber network Grade 2: Fine fiber network throughout most of the section; no coarse fibers~Grade 3: Diffuse fiber network with scattered thick coarse fibers but no mature collagen (negative to trichrome staining)~Grade 4: Diffuse, often course fiber network with areas of collagenization (positive trichrome staining)~Participants without an evaluable baseline result were assumed to have a baseline modified Bauermeister score of 0."|Baseline, year 1 (Cohort 1) and year 2 (Cohort 2)|The bone marrow analysis set includes participants who received at least 1 dose of romiplostim, who were recruited within the protocol supplement for the EU, Switzerland and Turkey and who had at least 1 bone marrow biopsy during the study after initiation of study treatment. Participants with available core biopsy results are included.|||percentage of participants||95% Confidence Interval|Number
2590804|NCT02279173|Secondary|Number of Participants With Adverse Events|"An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant, which does not necessarily have a causal relationship with study treatment.~A serious adverse event was defined as an AE that met at least 1 of the following criteria:~fatal~life threatening~required in-patient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event~Adverse events were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grading scale, where Grade 1 = mild AE; Grade 2 = moderate AE; Grade 3 = severe AE; Grade 4 = life-threatening or disabling; Grade 5 = death related to AE."|From first dose of study drug to the end of treatment (up to 36 months), up to the data cut-off date of 30 August 2018.|Participants who received at least 1 dose of romiplostim|||Participants|||Count of Participants
2590805|NCT02279173|Secondary|Number of Participants Who Developed Anti-Romiplostim or Anti- Thrombopoietin Neutralizing Antibodies|"Blood samples were first tested for the presence of binding antibodies to romiplostim or the peptide portion of romiplostim, and to endogenous thrombopoietin (eTPO). Samples testing positive for binding antibodies were then tested for neutralizing antibodies by assessing their ability to neutralize romiplostim and/or eTPO in a cell-based bioassay.~Participants who developed neutralizing antibodies are those who had a postbaseline positive result with a negative or no result at baseline. Transient is defined as a negative result at the participant's last time point tested within the study period."|Week 12, week 52 and every 24 weeks thereafter up to month 36, up to the data cut-off date of 20 March 2017.|Participants who received at least 1 dose of romiplostim and with a post-baseline antibody result.|||Participants|||Count of Participants
2590806|NCT02279173|Secondary|Number of Participants Reporting Use of Rescue Medications for ITP During the Treatment Period|"Rescue medication is defined as any medication or transfusion, other than romiplostim and excluded medications, that is administered after enrollment to the participant with the intent of raising platelet counts or to prevent bleeding and includes concomitant medications for ITP in which the dose and/or schedule was increased. Permitted rescue medications included the following:~corticosteroids~platelet transfusions~Intravenous immunoglobulin (IVIG)~azathioprine~anti-D immunoglobulin~danazol"|From first dose of romiplostim to the end of the treatment period, 36 months, up to the data cut-off date of 20 March 2017.|Efficacy analysis set|||Participants|||Count of Participants
2590807|NCT02279173|Secondary|Percentage of Time With an Increase in Platelet Count ≥ 20 x10⁹/L Above Baseline|"The percentage of time with an increase in platelet count ≥ 20 x 10⁹/L above baseline from week 2 until the end of the treatment period without rescue medication use within the past 4 weeks.~For each participant, the percentage of time with an increase in platelet count ≥ 20 x10⁹/L above baseline was calculated as the number of months the median platelet count was ≥ 20 x10⁹/L above baseline divided by the total number of months assessed."|Baseline and from week 2 to month 36, up to the data cut-off date of 20 March 2017.|Efficacy analysis set|||percentage of time||Inter-Quartile Range|Median
2590808|NCT02279173|Secondary|Percentage of Time With a Platelet Response During the Overall Treatment Period|"Platelet response was defined as a platelet count of ≥ 50 x 10⁹/L with no rescue medication use in the past 4 weeks.~Monthly platelet response was calculated based on the median platelet count during each month. For each participant, the percentage of time with platelet response was calculated as the number of months a platelet response was observed divided by the total number of months response was assessed."|From week 2 to the end of the treatment period, 36 months, up to the data cut-off date of 20 March 2017.|Efficacy analysis set|||percentage of time||Inter-Quartile Range|Median
2590843|NCT02278939|Secondary|Weight Change in Kilogram|Weight change in kilogram by group|Baseline to 3 months|Overweight/obese English-speaking Filipino American adults were randomized in a 1:1 ratio either to the intervention group or active control group.|||kilograms||Standard Deviation|Mean
2590809|NCT02279173|Primary|Percentage of Participants Who Developed Collagen After Exposure to Romiplostim|"The percentage of participants who developed collagen as evidenced by trichrome staining, defined as a Grade 4 on the modified Bauermeister grading scale:~Grade 0: No reticulin fibers demonstrable~Grade 1: Occasional fine individual fibers and foci of a fine fiber network Grade 2: Fine fiber network throughout most of the section; no coarse fibers~Grade 3: Diffuse fiber network with scattered thick coarse fibers but no mature collagen (negative to trichrome staining)~Grade 4: Diffuse, often course fiber network with areas of collagenization (positive trichrome staining)"|Year 1 (Cohort 1) and year 2 (Cohort 2)|The bone marrow analysis set includes participants who received at least 1 dose of romiplostim, who were recruited within the protocol supplement for the EU, Switzerland and Turkey and who had at least 1 bone marrow biopsy during the study after initiation of study treatment. Participants with available core biopsy results are included.|||percentage of participants||95% Confidence Interval|Number
2590810|NCT02279173|Primary|Percentage of Time With a Platelet Response During the First 6 Months of Treatment|"Platelet response was defined as a platelet count of ≥ 50 x 10⁹/L with no rescue medication use for ITP in the past 4 weeks.~Monthly platelet response was calculated based on the median platelet count during each month. For each participant, the percentage of time with platelet response during the first 6 months was calculated as the number of months a platelet response was observed divided by the total number of months response was assessed."|Week 2 to Month 6, platelet response was assessed every week.|The efficacy analysis set included all enrolled participants who received at least 1 dose of romiplostim|||percentage of time||Inter-Quartile Range|Median
2590811|NCT02279108|Secondary|Number of Patients With ICG Allergy|allergy is : redness, edema, itching, larynges edema and/or allergic shock|Month 2||||Participants|||Count of Participants
2590812|NCT02279108|Secondary|Number of Patients With ICG Allergy|allergy is : redness, edema, itching, larynges edema and/or allergic shock|1 hour after the end of the surgery||||Participants|||Count of Participants
2590813|NCT02279108|Secondary|Number of Patients With ICG Allergy|allergy is : redness, edema, itching, larynges edema and/or allergic shock|peroperative||||Participants|||Count of Participants
2590814|NCT02279108|Secondary|Comparison Between Groups of Time Surgery Node|time from incision time to the last node surgery|Peroperative||||minuts||Inter-Quartile Range|Median
2590815|NCT02279108|Secondary|Time From Injection of One Dose ICG Injection to Incision Time|time from injection of one dose ICG injection to incision time|Peroperative||||minutes||Inter-Quartile Range|Median
2590816|NCT02279108|Secondary|Comparison Between Groups of Anesthesia Time|time from the injection of anesthesic to the waking|Peroperative||||minutes||Full Range|Median
2590817|NCT02279108|Secondary|Comparison Between Groups of the Time of the Surgery|time from incision to wound closure|Peroperative||||minuts||Inter-Quartile Range|Median
2590818|NCT02279108|Secondary|Number of Lymph Nodes ICG Negative and Tc Positive|Number of lymph nodes Indocyanine green (ICG) negative and Tc (Technetium) positive|Peroperative||||lymph nodes|lymph nodes||Number
2590819|NCT02279108|Secondary|Number of Lymph Nodes ICG Positive and Tc Negative|Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium) negative|Peroperative||||lymph nodes|Lymph nodes||Number
2590820|NCT02279108|Secondary|Number of Lymph Nodes ICG Positive and Tc Positive|Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium)positive|Peroperative||||lymph nodes|lymph nodes||Number
2590821|NCT02279108|Primary|Number of Patients With Less Than Two Lymph Nodes Detected|Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone|peroperative||||Participants|||Count of Participants
2590822|NCT02279082|Primary|Number of Participants With Treatment Emergent Adverse Events||6 months||||Participants|||Count of Participants
2590823|NCT02279043|Secondary|Number of Participants Reporting Information-seeking From Peers|Report (Yes/No) in post-survey of whether participant had talked to women they know about IUC since study start. Outcome is count of participants reporting yes.|12 days post-baseline||||Participants|||Count of Participants
2590824|NCT02279043|Secondary|Number of Participants Reporting Information-seeking From a Health Care Provider|Report (Yes/No) in post-survey of whether participant had consulted a health care provider about IUC since study start. Outcome is count of participants reporting yes.|12 days post-baseline||||Participants|||Count of Participants
2590825|NCT02279043|Secondary|Number of Participants Reporting Information-seeking on Internet|Report (Yes/No) in post-survey of whether participant had looked on the Internet (outside of Birth Control Connect) for information on IUC since study start. Outcome is count of participants reporting yes.|12 days post-baseline||||Participants|||Count of Participants
2590826|NCT02279043|Secondary|Number of Participants Reporting Informational Support (Better Idea of What IUC Would be Like)|Response on 5-point Likert scale of agreement in post-survey on whether Birth Control Connect gave them a better idea of what using IUC would be like. Dichotomized as 4 or 5 (Agree or strongly agree) vs. 1, 2, or 3 (Strongly disagree, disagree, or neither agree nor disagree). Outcome is count of participants responding 4 or 5.|12 days post-baseline||||Participants|||Count of Participants
2590827|NCT02279043|Secondary|Number of Participants Reporting Informational Support (Receiving New Information From Birth Control Connect)|Response on 5-point Likert scale of agreement in post-survey on whether Birth Control Connect group gave participants information on IUC they didn't have before. Dichotomized as 4 or 5 (Agree or strongly agree) vs. 1, 2, or 3 (Strongly disagree, disagree, or neither agree nor disagree). Outcome is count of participants responding 4 or 5.|12 days post-baseline||||Participants|||Count of Participants
2590828|NCT02279043|Secondary|Number of Participants With Responses Indicating Knowledge of IUC Being More Effective Than Birth Control Pill|Correct response to post-survey item asking whether IUC is more, less, or as effective as the birth control pill (correct response: more effective).|12 days post-baseline||||Participants|||Count of Participants
2590829|NCT02279043|Secondary|Number of Participants With Responses Indicating Knowledge of IUC Effectiveness|Response on 5-point Likert scale of agreement in post-survey on IUC effectiveness. Dichotomized as 4 or 5 (Agree or strongly agree) vs. 1, 2, or 3 (Strongly disagree, disagree, or neither agree nor disagree). Outcome is count of participants responding 4 or 5.|12 days post-baseline||||Participants|||Count of Participants
2590876|NCT02278237|Secondary|Quality of Life (QOL)|Use validated disease specific QOL tools (i.e., asthma or COPD QOL tools)|up to 30 days|||||||
2590830|NCT02279043|Secondary|Number of Participants With Responses Indicating Knowledge of IUC Safety|Response on 5-point Likert scale of agreement in post-survey on IUC safety. Dichotomized as 4 or 5 (Agree or strongly agree) vs. 1, 2, or 3 (Strongly disagree, disagree, or neither agree nor disagree). Outcome is count of participants responding 4 or 5.|12 days post-baseline||||Participants|||Count of Participants
2590831|NCT02279043|Secondary|Mean Change in Attitude About Non-hormonal IUC as Method for Women in General Between Pre-survey and Post-survey|Responses to scale in pre- and post-surveys asking participants to rate non-hormonal IUC as a contraceptive method for women in general, with 0=terrible method and 10=great method|12 days post-baseline|Number analyzed is less than what is pictured in participant flow diagram because analysis for this outcome only includes those participants who have complete pre-survey and post-survey data pertaining to this outcome.|||units on a scale||95% Confidence Interval|Mean
2590832|NCT02279043|Secondary|Mean Change in Attitude About Non-hormonal IUC as Method for Self Between Pre-survey and Post-survey|Responses to scale in pre- and post-surveys asking participants to rate non-hormonal IUC as a contraceptive method for themselves, with 0=terrible method and 10=great method|12 days post-baseline|Number analyzed is less than what is pictured in participant flow diagram because analysis for this outcome only includes those participants who have complete pre-survey and post-survey data pertaining to this outcome.|||units on a scale||95% Confidence Interval|Mean
2590833|NCT02279043|Secondary|Mean Change in Attitude About Hormonal IUC as Method for Women in General Between Pre-survey and Post-survey|Responses to scale in pre- and post-surveys asking participants to rate hormonal IUC as a contraceptive method for women in general, with 0=terrible method and 10=great method|12 days post-baseline|Number analyzed is less than what is pictured in participant flow diagram because analysis for this outcome only includes those participants who have complete pre-survey and post-survey data pertaining to this outcome.|||units on a scale||95% Confidence Interval|Mean
2590834|NCT02279043|Secondary|Mean Change in Attitude About Hormonal IUC as Method for Self Between Pre-survey and Post-survey|Mean difference of responses to scale in pre- and post-surveys asking participants to rate hormonal IUC as a contraceptive method for themselves, with 0=terrible method and 10=great method|12 days post-baseline|Number analyzed is less than what is pictured in participant flow diagram because analysis for this outcome only includes those participants who have complete pre-survey and post-survey data pertaining to this outcome.|||units on a scale||95% Confidence Interval|Mean
2590835|NCT02279043|Primary|Number of Participants Reporting IUC Use|Self-reported use of IUC in post-survey|12 days post-baseline||||Participants|||Count of Participants
2590836|NCT02278952|Secondary|Association of Percentage of Mean Residual Expression (MRE%) of NFAT-related Cytokine Expression and Medication Dosages|Researchers observed percentage distribution of MRE values on the day of blood draws and measured tacrolimus, prednisone, and mycophenolate dose at the time of blood draw. Researchers observed the association between percentage of MRE on the day of blood draw and tacrolimus, prednisone, and mycophenolate dose, respectively, at the time of blood draw.|from 1 month up to 18 months post-transplant|Number of participants' study visits|||percentage of mean residual expression|biopsies|95% Confidence Interval|Least Squares Mean
2590837|NCT02278952|Secondary|Association of Percentage of Mean Residual Expression (MRE%) of NFAT-related Cytokine Expression and Tacrolimus Trough Level|Researchers observed percentage distribution of MRE values on the day of blood draws. Researchers measured tacrolimus concentration in blood drawn before tacrolimus dosage (trough) and observed the association between percentage of MRE on the day of blood draw and tacrolimus trough level.|from 1 month up to 18 months post-transplant|Number of participants' study visits|||percentage of mean residual expression|biopsies|95% Confidence Interval|Least Squares Mean
2590838|NCT02278952|Secondary|Association of Percentage of Mean Residual Expression (MRE%) of NFAT-related Cytokine Expression and Weeks Post-Transplant|Researchers observed percentage distribution of MRE values at time of blood draw from study visits at 4 weeks post-transplant up to 82 weeks post-transplant. Researchers observed association between percentage of MRE at time of blood draw and the number of weeks post-transplant.|from 1 month (4 weeks) up to 18 months (82 weeks) post-transplant|Number of participants' study visits|||percentage of mean residual expression|biopsies|95% Confidence Interval|Least Squares Mean
2590839|NCT02278952|Primary|Association of Percentage of Mean Residual Expression (MRE%) of NFAT-related Cytokine Expression and Infection|Researchers stratified blood draws based on subject's airway infection status at time of blood draw (based on biopsy results) and observed percentage distribution of MRE values within each infection status group. Researchers observed differences between MRE distributions within subjects with airway infection at time of blood draw and subjects with no infection diagnosis.|from 1 month up to 18 months post-transplant|Number of participants' study visits|||percentage of mean residual expression|biopsies|Standard Deviation|Mean
2590840|NCT02278952|Primary|Association of Percentage of Mean Residual Expression (MRE%) of NFAT-related Cytokine Expression and Acute Cellular Rejection|The prescribed tacrolimus dosage was determined by the treating physician who was not aware of the study-assay values. For the study assay, two blood draws were collected at a study visit during the assessment period (from 1 month up to 18 months post-transplant). The first draw occurred before tacrolimus dosage (trough) and the second occurred 90 to 120 minutes after tacrolimus dosage (peak). To determine MRE, whole blood was stimulated, RNA was extracted, and residual expression of NFAT-related cytokines (NFAT: nuclear factor of activated T-cells) was determined by quantitative polymerase chain reaction (qPCR). Researchers stratified blood draws based on subject's rejection pathology at time of blood draw and observed percentage distribution of MRE values within each rejection pathology group. Observed differences between MRE distributions within non-rejection group and rejection groups.|from 1 month up to 18 months post-transplant|Number of participants' study visits analyzed determined by the availability and quality of samples at both time points.|||percentage of mean residual expression|biopsies|Standard Error|Mean
2590841|NCT02278939|Secondary|Change in Body Mass Index (BMI)|Change in body mass index per group|Baseline to 3 months|Overweight/obese English-speaking Filipino American adults, were randomized either to the Intervention group (received a combination of mobile app, social media and in-person diabetes prevention intervention) or the active control group.|||kg/m^2||Standard Deviation|Mean
2590842|NCT02278939|Secondary|Percent of Weight|Percent of weight change from baseline to 3-months by group|Baseline to 3 months|Overweight/obese English-speaking Filipino American adults were randomized either to the Intervention group or the active control.|||percent of weight||Standard Deviation|Mean
2590844|NCT02278939|Primary|Count of Participants Who Completed the Study|at least 85% of participants enrolled complete the study program|Baseline to 6-months|Eligible participants enrolled and randomized = 67 ( Intervention group = 33 Control group =34). A Feasibility = at least 85% of all enrolled participant will have completed the study program.|||Participants|||Count of Participants
2590845|NCT02278783|Secondary|Frequency of Clinical Benefit (Stable Disease, Partial and Complete Response)|To determine the frequency of clinical benefit (stable disease, partial, and complete response) according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria|Scans will be done every 2 cycles (every 2 months) for disease assessment. Patients on average will be on treatment for 4-6 months|Study was terminated early, no analysis performed.||||||
2590846|NCT02278783|Secondary|Estimate Progression Free Survival|To estimate progression free survival for patients treated with this regimen|At 6 months patients will be checked for PFS, and compared to the expected probability of the patient being alive and progression-free for at least 6 months|Study was terminated early, no analysis performed.||||||
2590847|NCT02278783|Primary|Incidence of Adverse Events (Grade 2 or Higher), Assessed According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0|To determine the nature and degree of toxicity of Regorafenib in this cohort of patients. Toxicity will be summarized by attribution: regorafenib-related adverse events grade 2 or higher will be reported.|Patients will remain on treatment for approximately 4-6 months on average.||||participants|||Number
2590848|NCT02278783|Primary|6 Month Progression Free Survival (PFS)|To evaluate the anti-tumor activity of Regorafenib as measured by progression free survival at 6 months in patients with recurrent gynecological cancers|Patients will be checked for PFS after 6 months on treatment||||participants|||Number
2590849|NCT02278640|Secondary|Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Right Side.|"Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). Yes is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed."|Intraoperative|Safety Set With OP transection - All subjects in whom the procedure was started and for whom the transection of the ovarian pedicle was attempted.|||percentage of participants||95% Confidence Interval|Number
2590850|NCT02278640|Secondary|Percentage of Subjects Achieving Hemostasis at the Ovarian Pedicle on the Left Side.|"Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). Yes is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed."|Intraoperative|Safety Set With OP transection - All subjects in whom the procedure was started and for whom the transection of the ovarian pedicle was attempted.|||percentage of participants||95% Confidence Interval|Number
2590851|NCT02278640|Primary|Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Right Side.|"Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). Yes is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed."|Intraoperative|Safety Set - all subjects in whom the procedure was started.|||percentage of participants||95% Confidence Interval|Number
2590852|NCT02278640|Primary|Percentage of Subjects Achieving Hemostasis at the Named Vessel/Pedicle (UA or UP) on the Left Side.|"Hemostasis of the named vessel or pedicle is a dichotomous variable (i.e. yes or no). Yes is defined as the hemostatic transection of the uterine vasculature (left / right) with at least one use of the device in Advanced Hemostasis mode (a completed cycle with the second activation tone heard) without the use of additional hemostatic measures (i.e. tissue sealers, cautery devices, hemoclips, staples, sutures, fibrin sealants, etc.) other than the Harmonic ACE®+7 device. Multiple applications of the Advanced Hemostasis mode and/or additional applications of the device in a maximum (MAX) or minimum (MIN) mode are allowed."|Intraoperative|Safety Set - all subjects in whom the procedure was started.|||percentage of participants||95% Confidence Interval|Number
2590853|NCT02278614|Primary|Non-inferiority of T2347 Compared With Xalacom® on Change in Mean IOP at 9.00 am (± 1 Hour) Between the Baseline (Day 0) and Day 84 in the Worse Eye|"the non-inferiority of T2347 unpreserved eye drops compared with Xalacom® on change in mean IOP at 9.00 am (± 1 hour) between the baseline (Day 0) and Day 84 in the worse eye.~Two relevant time points are considered for this primary criteria: D0 and Day 84."|Day 84|"The primary efficacy analysis (mean change in IOP from baseline to Day 84) was performed on the mITT set (236 patients).~mITT set: All ITT patients with at least one baseline and one post-randomisation efficacy assessment following study treatment.~242 patients described in the participant flow correpsond to the ITT & Safety set."|||mm Hg||Standard Error|Least Squares Mean
2590854|NCT02278562|Secondary|Change in Skeletal Muscle Net Protein Balance|Skeletal muscle net protein balance is the difference between protein synthesis (anabolism) and protein breakdown (catabolism) in the skeletal muscles.|baseline and 3 months|The number of participants for analysis was based on those subjects who completed the 3-month study. The analysis was per protocol.|||μg/100 ml/min||Inter-Quartile Range|Median
2590855|NCT02278562|Secondary|Change in Whole-body Net Protein Balance|Whole-body net protein balance is the difference between protein synthesis (anabolism) and protein breakdown (catabolism) in the whole body|baseline and 3 months|The number of participants for analysis was based on those subjects who completed the 3-month study. The analysis was per protocol.|||mg/kg/min||Inter-Quartile Range|Median
2605746|NCT02107014|Primary|Change in IL-21 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2590856|NCT02278562|Primary|Change in Leucine Disposal Rate (LDR)|LDR is a sensitive laboratory assessment of amino acid metabolism|baseline and 3 months|The number of participants for analysis was based on those subjects who completed the 3-month study. The analysis was per protocol.|||mg/kg/min||Inter-Quartile Range|Median
2590857|NCT02278484|Secondary|Number of Subjects Who Undergo a Revision or Additional Surgery During the Study|Any surgical intervention that is performed in the sinus(es) following the index procedure will be reported|Procedure-6 month follow up|All participants|||Participants|||Count of Participants
2590858|NCT02278484|Secondary|Change in Quality of Life From Baseline Through Completion|Change in sinonasal symptom severity between the baseline preprocedure assessment and follow-up assessment. Sinus symptom severity is measured using the Sinus and Nasal Quality of Life Survey (SN-5) that is a validated tool for use in pediatric patients (completed by caregivers). The 5 survey items are scored from 1 (best) to 7 (worst) and averaged to provide an overall score.|Baseline to 6-month follow-up|All participants|||Units on a scale||Standard Deviation|Mean
2590859|NCT02278484|Primary|Complications|Number of subjects who experience complications. Complications are defined as serious device or procedure related adverse events.|Index procedure through 3-month follow-up|All participants|||participants|||Number
2590860|NCT02278484|Primary|Technical Success: Sinuses Successfully Treated With Balloon Dilation|Number of successful dilations out of all attempted dilations. Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus.|Index procedure|All sinus dilations attempted in all participants|||sinus dilation attempts|Sinuses||Number
2590861|NCT02278471|Secondary|Inflammatory Profile|"Plasma levels of IL-17, IFN-g, IL-6, IL-10, high sensitivity C-reactive protein, TNFa, IL-4.~Note: Due to budgetary constraints, we did not immediately perform measurement of the secondary biomarker endpoints at the conclusion of the trial. We have secured alternate funding to perform biomarker measurements (glycemic markers, inflammatory profiles, and drug metabolites), which will be conducted in the next year."|Baseline and 12 months||2020-12-31|12/2020||||
2590862|NCT02278471|Secondary|Insulin Resistance|"Measurement of HOMA-IR using fasting glucose and insulin.~Note: Due to budgetary constraints, we did not immediately perform measurement of the secondary biomarker endpoints at the conclusion of the trial. We have secured alternate funding to perform biomarker measurements (glycemic markers, inflammatory profiles, and drug metabolites), which will be conducted in the next year."|Baseline and 12 months||2020-12-31|12/2020||||
2590863|NCT02278471|Secondary|LDL Cholesterol|polypill versus usual care|2 months||||mg/dL||Standard Deviation|Mean
2590864|NCT02278471|Secondary|Drug Metabolite Profile|"LC/MS/MS-based drug metabolite profile assay screen in the polypill arm.~Note: Due to budgetary constraints, we did not immediately perform measurement of the secondary biomarker endpoints at the conclusion of the trial. We have secured alternate funding to perform biomarker measurements (glycemic markers, inflammatory profiles, and drug metabolites), which will be conducted in the next year."|12 months||2020-12-31|12/2020||||
2590865|NCT02278471|Secondary|Medication Adherence|polypill-percentage of pills taken, evaluated via pill counts|2 months|adherence not assessed in usual care arm; incomplete data for 32 polypill participants, resulting in 106 analyzed of 138 polypill participants who completed 2 month visits|||percentage of pills taken||Inter-Quartile Range|Median
2590866|NCT02278471|Secondary|Systolic Blood Pressure|polypill versus usual care|2 months|The numbers of participants analyzed do not match those of the completed (in the participant flow overview) because this assessment was completed at baseline and 2 months; 291 patients (153 usual care, 138 Polypill) completed 2-month follow-up, whereas 275 (147 Usual Care, 128 Polypill) completed 12-month follow-up.|||mm Hg||Standard Deviation|Mean
2590867|NCT02278471|Primary|LDL Cholesterol|Polypill versus usual care|12 months|# of participants in polypill arm analyzed (126) does not match number of polypill participants completed (128; in the participant flow overview) because we were unable to obtain LDL values at baseline for 2 Polypill participants. The lab was unable to calculate and a reflex direct LDL was not processed.|||mg/dL||Standard Deviation|Mean
2590868|NCT02278471|Primary|Medication Adherence-Percentage of Pills Taken|polypill arm-evaluation via pill counts.|12 months|adherence not assessed in usual care arm; incomplete data for 27 polypill participants, resulting in 101 analyzed of 128 polypill participants who completed 12 month visits|||percentage of pills taken||Inter-Quartile Range|Median
2590869|NCT02278471|Primary|Systolic Blood Pressure|polypill versus usual care|12 months||||mm Hg||Standard Deviation|Mean
2590870|NCT02278328|Primary|GABA (Left Hemisphere)|GABA/Cr ratio arising from a voxel in the left superior temporal gyrus|1 hour per intervention followed by a 1 week washout for a total of three weeks|For placebo, 5 cases were unevaluable. For 15mg, 7 cases were unevaluable. For 30mg, 4 cases were unevaluable|||ratio||Standard Deviation|Mean
2590871|NCT02278328|Primary|Steady State Inter Trial Coherence (Right Hemisphere)|The inter trial coherence (ITC) of auditory steady state response arising from the right cerebral hemisphere|1 hour per intervention followed by a 1 week washout for a total of three weeks|For placebo, 3 cases and for 15mg dose and 30mg doses, 1 case each was unevaluable due to artifact.|||unitless||Standard Deviation|Mean
2590872|NCT02278328|Primary|Steady State Inter Trial Coherence (Left Hemisphere)|The inter trial coherence (ITC) of auditory steady state response arising from the left cerebral hemisphere|1 hour per intervention followed by a 1 week washout for a total of three weeks|For placebo, 3 cases and for 15mg and 30mg doses, 1 case each was unevaluable due to artifact.|||unitless||Standard Deviation|Mean
2590873|NCT02278328|Primary|M50 Latency (Right Hemisphere)|The latency of the M50 auditory evoked response component arising from the right cerebral hemisphere|1 hour per intervention followed by a 1 week washout for a total of three weeks|For placebo and 15mg dose, 1 case each was unavailable due to artifact. At 30mg dose, 4 cases were unevaluable due to artifact|||ms||Standard Deviation|Mean
2590874|NCT02278328|Primary|M50 Latency (Left Hemisphere)|The latency of the M50 auditory evoked response component arising from the left cerebral hemisphere|1 hour per intervention followed by a 1 week washout for a total of three weeks|For placebo and 15mg dose, 1 case each was unavailable due to artifact. At 30mg dose, 2 cases were unevaluable due to artifact|||ms||Standard Deviation|Mean
2590875|NCT02278237|Secondary|Self-efficacy of Inhaler Technique|"Assess patient's confidence in using their inhalers.~We will ask patients to report if they: strongly disagree/disagree/neutral/agree/strongly agree with the statement: I am confident that I know how to use this respiratory inhaler correctly."|up to 30 days|||||||
2590877|NCT02278237|Secondary|Symptom Burden|Assess patient's respiratory symptoms/morbidity, which includes the Borg symptom score, Asthma Symptom Severity Index (ASSI), Chronic Bronchitis Symptom Questionnaire, COPD Severity Score (CSS), Airway Questionnaire (AQ-20), COPD Helplessness Index (CHI) and demographic and other clinical information.|up to 30 days|||||||
2590878|NCT02278237|Primary|Number of Participants With Inhaler Misuse Pre- and Post-VME|"Assess patient's inhaler technique using Inhaler checklists by the trained assessor.~The primary outcome will be comparing post-intervention to pre-intervention scores; secondary outcome will be 30 days post-discharge visit~We will define inhaler technique in two ways:~Correct Use (i.e., >75% of steps correct)~Mastery (i.e., perfect technique, 100% steps correct)"|Up to 30 days||||participants|||Number
2590879|NCT02278146|Secondary|Overactive Bladder Arm|Percentage of participants with less daily voids from baseline to 3 weeks.|up to 3 weeks||||percentage of participants|||Number
2590880|NCT02278146|Secondary|Stress Incontinence Arm|Percentage of participants with less daily leaks from baseline to 3 weeks.|up to 3 weeks||||percentage of subjects|||Number
2590881|NCT02278146|Primary|Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study|Documentation, follow-up and characterization of all adverse events in all subjects who use the ParaPatch System, through the completion of the study.|up to 3 weeks||||participants|||Number
2590882|NCT02278120|Secondary|Change From Baseline in the Global Health Status/QOL Scale Score of the EORTC QLQ-C30|Patient reported outcomes for health related quality of life|Up to approximately 25 months|||||||
2590883|NCT02278120|Secondary|Time to 10% Deterioration in the Global Health Status/QOL Scale Score of the EORTC QLQ-C30|Patient reported outcomes for health related quality of life|Up to approximately 25 months|||||||
2590884|NCT02278120|Secondary|Time to Definitive Deterioration of the ECOG PS From Baseline|Time to deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|Baseline, up to approximately 25 months|||||||
2590885|NCT02278120|Secondary|Duration of Response (DOR) Per Investigator's Assessment - Patients With Confirmed Complete Response (CR) or Partial Response (PR)|Time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer|Up to approximately 25 months|Full Analysis Set (FAS): All randomized patients were included in the FAS (intent-to-treat population).|||Months||95% Confidence Interval|Median
2590886|NCT02278120|Secondary|Time to Response (TTR) Per Local Investigator's Assessment|Time to response is the time from the date of randomization to the first documented response (CR or PR, which must be confirmed subsequently) according to RECIST 1.1. All patients will be included in time to response calculations. Patients who do not achieve a confirmed response will be censored at the maximum follow-up time (i.e. first patient first visit to last patient last visit used for the analysis) for patients who had a PFS event (i.e. either progressed or died due to any cause) or at the date of last adequate tumor assessment otherwise.|Up to approximately 25 months|Full Analysis Set (FAS): All randomized patients were included in the FAS (intent-to-treat population).|||months||95% Confidence Interval|Median
2590887|NCT02278120|Secondary|Safety and Tolerability of LEE011|Safety and tolerability will be determined by type, frequency and severity of adverse events and laboratory abnormalities per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03|Up to approximately 26 months|||||||
2590888|NCT02278120|Secondary|Clinical Benefit Rate (CBR)|Percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeks or longer as defined in RECIST 1.1.CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease: PD = At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20% the sum must also demonstrate an absolute increase of at least 5 mm.|Up to approximately 25 months|Full Analysis Set (FAS): All randomized patients were included in the FAS (intent-to-treat population).|||Percentage of participants||95% Confidence Interval|Number
2590889|NCT02278120|Secondary|Overall Response Rate (ORR) Per Local Assessment|ORR is the percentage of participants with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|Up to approximately 25 months|Full Analysis Set (FAS): All randomized patients were included in the FAS (intent-to-treat population).|||Percentage of participants||95% Confidence Interval|Number
2590890|NCT02278120|Secondary|Overall Survival (OS)|Time from date of randomization to the date of death from any cause|Up to approximately 69 months|||||||
2590891|NCT02278120|Primary|Progression Free Survival (PFS) Per Investigator's Assessment|PFS, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause and assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1]. PFS was assessed via a local radiology assessment according to RECIST 1.1|Up to approximatley 25 months|Full Analysis Set (FAS): All randomized patients were included in the FAS (intent-to-treat population).|||Months||95% Confidence Interval|Median
2590892|NCT02278003|Secondary|Memory Threshold|At the presentation of each picture, the child will be asked whether or not he/she remembers having seen it previously. Each response will be coded as correct (true positives and true negatives) or incorrect (false positives and false negatives).|1 year||||Hit rate||Standard Deviation|Mean
2590893|NCT02278003|Primary|Sedation Threshold|During the 10-minute infusion of propofol, children will be presented with pictures at 5-second intervals and asked to name the picture. They will be asked to name each picture (e.g., cat, tree, pencil, etc.). A valid response is naming of the picture within 5 seconds, either correctly or incorrectly.The important response measure is whether the child is awake enough to perform the naming task.|1 year||||Participants|||Count of Participants
2592215|NCT02260492|Primary|FEV1 Trough|Bioequivalence comparison of trough lung function (FEV1) after 4 weeks of treatment with OT329 SOLIS or ADVAIR DISKUS.|Post-4 weeks of treatment|Intent-to-Treat|||Liters||Standard Deviation|Mean
2590894|NCT02277990|Secondary|Kaplan-Meier Estimate of a Major Infection Throughout Follow-up|"CIED infections are defined as (1) superficial cellulitis in the region of the CIED pocket with wound dehiscence, erosion, or purulent drainage, (2) deep incisional or organ/space (generator pocket) surgical site infection that meets the Centers for Disease Control and Prevention criteria, independent from time of surgery, (3) persistent bacteremia, or (4) endocarditis.~Major CIED infections are defined as a CIED infection resulting in one or more of the following:~CIED system removal~Any invasive procedure (e.g. pocket opened) without system removal~Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage~Death"|Throughout study follow-up Kaplan-Meier Estimate is at 36 Months||||Percentage of subjects||95% Confidence Interval|Number
2590895|NCT02277990|Secondary|12 Month Kaplan-Meier Estimate of a CIED Procedure Related or System Related Complication|"A CIED system related event is defined as an adverse event related to the CIED system which includes the device, leads, implant tool(s), programmer, or TYRX envelope (if applicable)~A CIED procedure related event is defined as an adverse event that occurs due to any procedure related to the implantation or surgical modification of the system including the TYRX envelope (if applicable)~A procedure or system related complication is defined as an adverse event related to a CIED procedure or the CIED system that results in at least one of the following:~Death,Termination of significant device function, Invasive intervention"|Implant to 12 months|Per the Statistical Analysis Plan, the statistical inference for this objective was based on the As-Treated cohort instead of the Intention-to-Treat cohort. Per the cohort definition, subjects are analyzed based on the treatment (envelope or no envelope) and the device class (low or high power) that was actually received.|||Percentage of subjects|||Number
2590896|NCT02277990|Secondary|12 Month Kaplan-Meier Estimate of Major or Minor CIED Infection|Major CIED infections are defined above. Minor CIED infections are defined as CIED infections that do not meet the definition of a major CIED infection|Implant to 12 months||||Percentage of subjects||95% Confidence Interval|Number
2590897|NCT02277990|Primary|12 Month Kaplan-Meier Estimate of Major CIED Infection Rate|"CIED infections are defined as (1) superficial cellulitis in the region of the CIED pocket with wound dehiscence, erosion, or purulent drainage, (2) deep incisional or organ/space (generator pocket) surgical site infection that meets the Centers for Disease Control and Prevention criteria, independent from time of surgery, (3) persistent bacteremia, or (4) endocarditis.~Major CIED infections are defined as a CIED infection resulting in one or more of the following:~CIED system removal~Any invasive procedure (e.g. pocket opened) without system removal~Treatment with antibiotic therapy if the subject is not a candidate for system removal and infection recurrence after completion of antibiotic therapy or evidence of deep infection with wound dehiscence, erosion, or purulent drainage~Death"|Implant to 12 months||||Percentage of subjects||95% Confidence Interval|Number
2590898|NCT02277925|Secondary|Pelvic Floor Distress Inventory-20 (PFDI-20) Mean Score|Condition-specific questionnaire, pelvic floor distress inventory-20 (PFDI-20) is used. Minimum value is 0. Maximum is 300. Higher scores mean more bothersome symptoms.|1 year||||score on a scale||Standard Deviation|Mean
2590899|NCT02277925|Secondary|Number of Participants With Treatment Success|Total number of participants with treatment success, which was a composite measure of 1) leading edge of prolapse not beyond hymen and apex not descended > 1/3 of vaginal length, 2) no subjective feeling of bulge on validated questionnaire, and 3) no prolapse re-treatment with pessary or surgery|1 year|Participants who underwent sacral colpopexy surgery with 1-year follow-up|||Participants|||Count of Participants
2590900|NCT02277925|Primary|Number of Participants With Vaginal Mesh or Suture Exposure|Total number of participants with vaginal mesh and/or suture exposure thru 1 year|1 year|Participants who underwent sacral colpopexy surgery with 1-year follow up data|||Participants|||Count of Participants
2590901|NCT02277769|Secondary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 16|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline up to Week 16|Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated.|||percentage of participants|||Number
2590902|NCT02277769|Secondary|Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 16|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline up to Week 16|Safety analysis set which included all randomized participants who received any study drug, and was analyzed based on the treatment received.|||percentage of participants|||Number
2590912|NCT02277769|Secondary|Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-50 scores at Week 16 were considered as non-responders.|Week 16|Full analysis set (FAS) included all randomized participants.|||percentage of participants|||Number
2590903|NCT02277769|Secondary|Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic Treatment|Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. Statistical significance in the hierarchical testing of secondary hypotheses was broken at this endpoint. Therefore, subsequent secondary efficacy endpoints were not tested for statistical significance.|Baseline up to Week 16|Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated.|||percentage of participants|||Number
2590904|NCT02277769|Secondary|Percent Change From Baseline in Weekly Average of Peak Daily Pruritus NRS Score to Week 2|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 2|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
2590905|NCT02277769|Secondary|Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 16|Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
2590906|NCT02277769|Secondary|Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16|HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
2590907|NCT02277769|Secondary|Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16|The POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
2590908|NCT02277769|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16|The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
2590909|NCT02277769|Secondary|Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16|SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
2590910|NCT02277769|Secondary|Change From Baseline in Percent Body Surface Area (BSA) to Week 16|BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percentage of body surface area||Standard Deviation|Mean
2590911|NCT02277769|Secondary|Percentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-90 responders were the participants who achieved ≥90% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-90 scores at Week 16 were considered as non-responders.|Week 16|Full analysis set (FAS) included all randomized participants.|||percentage of particpants|||Number
2590913|NCT02277769|Secondary|Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
2590914|NCT02277769|Secondary|Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
2590915|NCT02277769|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.|Baseline to Week 2|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.|||percentage of participants|||Number
2590916|NCT02277769|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 4 were considered as non-responders.|Baseline to Week 4|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.|||percentage of participants|||Number
2590917|NCT02277769|Secondary|Percent Change From Baseline in Weekly Average of Peak Pruritus Numerical Rating Scale (NRS) Score to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
2590918|NCT02277769|Secondary|Percentage of Participants With Improvement (Reduction ≥3 Points) in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥3.|||percentage of participants|||Number
2590919|NCT02277769|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.|||percentage of participants|||Number
2590920|NCT02277769|Secondary|Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.|Week 16|Full analysis set included all randomized participants.|||percentage of participants|||Number
2590921|NCT02277769|Primary|"Percentage of Participants With Investigator's Global Assessment (IGA) Score of 0 or 1 and Reduction From Baseline of ≥2 Points at Week 16"|"IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of 0 or 1 and a reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders."|Week 16|Full analysis set included all randomized participants.|||percentage of participants|||Number
2605673|NCT02107339|Secondary|Pain Scores on Postoperative Day 2|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores 48 hours after PACU admission||||units on a scale||Inter-Quartile Range|Median
2590922|NCT02277743|Secondary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Treatment Discontinuation From Baseline Through Week 16|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline up to Week 16|Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated.|||percentage of participants|||Number
2590923|NCT02277743|Secondary|Percentage of Participants With Treatment Emergent Serious Adverse Events (TESAEs) From Baseline Through Week 16|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline up to Week 16|Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated.|||percentage of participants|||Number
2590924|NCT02277743|Secondary|Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) Requiring Systemic Treatment|Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to the end of study [Week 28]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. Statistical significance in the hierarchical testing of secondary hypotheses was broken at this endpoint. Therefore, subsequent secondary efficacy endpoints were not tested for statistical significance.|Baseline up to Week 16|Safety analysis set (SAF) which included all randomized participants who received any study drug, and was analyzed as treated.|||percentage of participants|||Number
2590925|NCT02277743|Secondary|Percent Change From Baseline in Peak Daily Pruritus NRS Score to Week 2|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 2|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
2590926|NCT02277743|Secondary|Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 16|Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
2590927|NCT02277743|Secondary|Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16|HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
2590928|NCT02277743|Secondary|Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16|The POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
2590929|NCT02277743|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16|The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
2590930|NCT02277743|Secondary|Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16|SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
2590931|NCT02277743|Secondary|Change From Baseline in Percent Body Surface Area (BSA) to Week 16|BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percentage of body surface area||Standard Deviation|Mean
2590932|NCT02277743|Secondary|Percentage of Participants With Eczema Area and Severity Index-90 (EASI-90) (≥90% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-90 responders were the participants who achieved ≥90% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-90 scores at Week 16 were considered as non-responders.|Week 16|Full analysis set (FAS) included all randomized participants.|||percentage of participants|||Number
2590933|NCT02277743|Secondary|Percentage of Participants With Eczema Area and Severity Index-50 (EASI-50) (≥50% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI-50 scores at Week 16 were considered as non-responders.|Week 16|Full analysis set (FAS) included all randomized participants.|||percentage of participants|||Number
2590934|NCT02277743|Secondary|Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
2590935|NCT02277743|Secondary|Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
2590936|NCT02277743|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 2 were considered as non-responders.|Baseline to Week 2|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.|||percentage of participants|||Number
2590937|NCT02277743|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported. Values after first rescue treatment were set to missing and subjects with missing peak NRS at Week 4 were considered as non-responders.|Baseline to Week 4|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.|||percentage of participants|||Number
2590938|NCT02277743|Secondary|Percent Change From Baseline in Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Deviation|Mean
2590939|NCT02277743|Secondary|Percentage of Participants With Improvement (Reduction ≥3 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥3.|||percentage of participants|||Number
2590940|NCT02277743|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing peak NRS at Week 16 were considered as non-responders.|Baseline to Week 16|Full analysis set (FAS) included all randomized participants. Here, number of participants analyzed = participants with baseline peak pruritus NRS ≥4.|||percentage of participants|||Number
2590941|NCT02277743|Secondary|Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment use were set to missing and participants with missing EASI score at Week 16 were considered as non-responders.|Week 16|Full analysis set (FAS) included all randomized participants.|||percentage of participants|||Number
2590942|NCT02277743|Primary|"Percentage of Participants With Investigator's Global Assessment (IGA) Score of 0 or 1 and Reduction From Baseline of ≥2 Points at Week 16"|"IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of 0 or 1 and a reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue treatment were set to missing and participants with missing IGA scores at Week 16 were considered as non-responders."|Week 16|Full analysis set included all randomized participants.|||percentage of participants|||Number
2590943|NCT02277691|Secondary|Change From Baseline in Home Sitting Clinic Systolic and Diastolic Blood Pressure at Each Visit|The change in home morning SPB and DBP measured at End of Week 12, End of Treatment (Up to Week 52) relative to baseline.|Baseline (End of Run-in Period, Week 0), End of Week 12 and End of Treatment (Up to Week 52)|The full analysis set is defined as the participants who received at least 1 dose of the study drug for the treatment period. Here 'n' is number of participants analysed at the given time­point.|||mmHg||Standard Deviation|Mean
2590944|NCT02277691|Secondary|Change From Baseline in Office Trough Sitting Clinic Systolic and Diastolic Blood Pressure at Each Visit|The change in office trough SBP and DBP measured at Weeks 12 last observation was carried forward (LOCF) and 52 (LOCF) relative to baseline. Sitting blood pressure was measured at least 3 times. Each measurement session ended once blood pressure was found stable at 2 consecutive measurements. The average of the last 2 measurements of office sitting blood pressure was used.|Baseline (End of Run-in Period, Week 0) and Weeks 12 (LOCF) and 52 (LOCF)|The full analysis set is defined as the participants who received at least 1 dose of the study drug for the treatment period. Here 'n' is number of participants analyzed at the given timepoint.|||mmHg||Standard Deviation|Mean
2590945|NCT02277691|Primary|Number of Participants With Markedly Abnormal Clinical Laboratory Tests|The number of participants with any markedly abnormal clinical laboratory test values collected throughout study. RBC = Red blood cells, ALT = alanine aminotransferase, AST = aspartate aminotransferase, GGT = gamma-glutamyl transferase, LLN = lower limit of normal or lower reference limit, ULN = upper limit of normal or upper reference limit. Laboratory vallues were considered abnormal if they were beyond the values defined in categories.|Baseline up to Week 52|The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
2590946|NCT02277691|Primary|Number of Participants With Treatment Emergent Adverse Event (TEAE) Related to Electrocardiogram (ECG)|Reported TEAE is categorized into cardiac disorders and investigations system organ class (SOC) related to ECG.|Baseline up to Week 52|The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
2590947|NCT02277691|Primary|Number of Participants With Treatment Emergent Adverse Event (TEAE) Related to Body Weight|Reported TEAE is categorized into investigations System Organ Class (SOC) related to body weight.|Baseline up to Week 52|The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
2590948|NCT02277691|Primary|Number of Participants With Markedly Abnormal Vital Signs Values|Vital signs included supine and standing systolic and diastolic blood pressure (SBP and DBP) respectively and office sitting pulse. Vital signs were considered abnormal if they were beyond the values defined in categories.|Baseline up to Week 52|The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
2590949|NCT02277691|Primary|Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|Baseline up to Week 52|The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||Participants|||Count of Participants
2590957|NCT02277626|Primary|Comfort Level After Receiving Therapy With Either ElectroFlo 5000 / Vest|Comfort assessed on a scale of 1-10 by patients after therapy after each visit (1 being most comfortable, 10 being most un-comfortable)|End of study visit per intervention||||units on a scale||Full Range|Mean
2590958|NCT02277626|Primary|Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / Vest.|Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.|End of study visit per intervention||||percentage of predicted value||Full Range|Mean
2590959|NCT02277626|Primary|Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / VEST.|Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive.|End of study visit per intervention||||percentage of predicted value||Full Range|Mean
2590960|NCT02277626|Secondary|Dry Sputum Weight|Sputum was collected in pre-measured cups in a blinded fashion, dessicated and measured dry|End of study visit per intervention||||gram||Full Range|Mean
2590961|NCT02277626|Primary|Wet Sputum Weight|Sputum was collected in pre-measured cups in a blinded fashion|End of study visit per intervention||||grams||Full Range|Mean
2590962|NCT02277548|Primary|Average/Cumulative Opioid Dose||18 months||||mg||Standard Deviation|Mean
2590963|NCT02277249|Primary|Patient Discomfort With Digoxin Injection (Pain Score)|"Pain score (indicated by patient reporting pain level from 0 (no hurt) to 5 (hurts worst) at time of digoxin injection)"|At time of study (immediate)||||Units on a scale||Standard Deviation|Mean
2590964|NCT02277119|Primary|Optic Disc Measurement (Cup Size)|Reporting of the Cup size difference between the Maestro and iVue|1 Hour||||Microns cubed||Standard Deviation|Mean
2590965|NCT02277119|Primary|Full Retinal Thickness Measurement|Full Retinal Thicknesses Measurement|1 Hour|Glaucomatous eyes were not scanned and analyzed in the Full Retina Thickness portion of the study. Since the imaging is done in a different area of the eye compare to Retinal Nerve Fiber Layer participants analyzed will be different between these measurement areas.|||Microns||Standard Deviation|Mean
2590966|NCT02277119|Primary|Retinal Nerve Fiber Layer (RNFL) Thickness Measurements|RNFL thickness measured|1 Hour||||Microns||Standard Deviation|Mean
2590967|NCT02277119|Primary|Optic Disc Measurements (Optic Disc Size)|Reporting of the Optic Disc Size difference between the Maestro and iVue|1 Hour||||Mircrons squared||Standard Deviation|Mean
2590968|NCT02277093|Secondary|Overall Survival (OS)|-The follow-up time for OS was calculated from the start of treatment until death or on the final collection date of data on 10/27/2016.|Through completion of follow-up (median follow-up was 6.61 months)||||months||95% Confidence Interval|Median
2590969|NCT02277093|Secondary|Time to Progression (TTP)||Through completion of follow-up (median follow-up was 6.61 months)|Only patients who had their first measurement scans were evaluable for this outcome measure.|||months||Standard Deviation|Mean
2590970|NCT02277093|Secondary|Overall Response Rate (ORR)|"The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.~Using RECIST 1.1~The follow-up time was calculated from the start of treatment until death or on the final collection date of data on 10/27/2016."|Through completion of follow-up (median follow-up was 6.61 months)||||Participants|||Count of Participants
2590971|NCT02277093|Secondary|Toxicity Profile and Tolerability as Measured by Reportable Adverse Events|"The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.~Reportable adverse events will be tracked for 28 days following the last day of study treatment. For the purposes of this protocol, reportable adverse events are events that are greater than or equal to grade 2 and are considered possibly, probably, or definitely related to study treatment."|Up to 28 days following last day of study treatment||||adverse event|||Number
2590972|NCT02277093|Primary|Progression-free Survival (PFS)|"PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.~Progression - at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).~Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase."|Through completion of follow-up (median follow-up was 6.61 months)||||months||Inter-Quartile Range|Median
2590973|NCT02277054|Secondary|Number of Participants With Improved Visual Acuity at 12 Months|Improvement of 1 or more lines in Corrected Distance Visual Acuity in comparison to preoperative visual acuity|12 months||||Participants|||Count of Participants
2590974|NCT02277054|Secondary|Number of Participants With Healed Cornea at 12 Months|Cornea is considered to have healed up when there is no defect of corneal epithelium, which is confirmed by fluorescein staining of corneal surface|12 months||||Participants|||Count of Participants
2590975|NCT02277054|Primary|Incidence of Treatment-Emergent Adverse Events|Implant safety and tolerability will be measured by absence/presence of its lysis as well as by degree of eye inflammation based on conjunctival injection, perifocal corneal haze, aqueous humor transparency, increased intraocular pressure and self reported postoperative pain. Each item is scored 0-4: 0 = no symptom, 4 = severe symptom.|12 months||||events|||Number
2590983|NCT02276872|Secondary|Change From Baseline in Right Ventricular (RV) Stroke Volume Index at Week 24|Cardiac MRI imaging was performed in all subjects aged 10 years and older at Baseline and Week 24/Premature Termination; imaging was optionally performed in subjects under the age of 10 years. The subject's BP was taken immediately prior to the cMRI assessment in the supine position to measure vascular parameters.|Baseline and Week 24|Safety Population - Number of Subjects with both Baseline and Week 24 Measurements|||mL/beat//m2||Standard Error|Mean
2605674|NCT02107339|Secondary|Pain Scores on Postoperative Day One|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores one day after PACU admission||||units on a scale||Inter-Quartile Range|Median
2590976|NCT02276963|Primary|Change in Neurological Disability - Expanded Disability Scale Score|The Kurtzke Expanded Disability Status Scale (EDSS) was developed to measure the disability status of subjects with demyelinating disease. It allows an objective quantification of the level of functioning that could be widely and reproducibly used by researchers and health care providers. The EDSS provides a total score on a scale that ranges from 0 to 10 where 0 is normal and 10 is deceased. Increasing disability is reflected in an increasing EDSS score.|On admission to the hospital on day 1, on discharge 5-21 days later and on follow up at 90 days|5 subjects had EDSS measurements at the first three time points: baseline, admission and discharge. 3 subjects had EDSS scores with an additional EDSS measurement at 90-day follow up.|||EDSS unit score||Inter-Quartile Range|Median
2590977|NCT02276872|Secondary|Area Under the Concentration-Time Curve From Zero to 8 Hours Post-dose (AUC0-8)|Cohort 1 had three blood samples obtained at 'Time 0' and at 4 and 8 hours at the Baseline visit. All cohorts had five blood samples obtained from at 'Time 0' and at 2, 4, 6, and 8 hours at the Week 24 visit. Plasma samples were analyzed for treprostinil using a validated bioanalytical plasma assay. Individual and mean treprostinil plasma concentration data and treprostinil pharmacokinetic parameters, such as peak observed plasma concentration (Cmax), time to peak plasma concentration (Tmax), area under the plasma concentration-time curve (AUC0-inf), were determined as able.|Baseline (Cohort 1 only; 0, 4, 8 hours while receiving IV/SC Remodulin) and Week 24 (all cohorts; 0, 2, 4, 6, 8 hours post-dose oral treprostinil)|PK Population. To provide a larger sample size for PK analysis, data for Cohorts 1, 2, and 3 following oral treprostinil administration were combined and compared to parenteral infusion (Cohort 1 Baseline data; Remodulin IV/SC).|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2590978|NCT02276872|Secondary|Area Under the Concentration-Time Curve From Zero to Tau Hours Post-dose (AUCtau)|Cohort 1 had three blood samples obtained at 'Time 0' and at 4 and 8 hours at the Baseline visit. All cohorts had five blood samples obtained from at 'Time 0' and at 2, 4, 6, and 8 hours at the Week 24 visit. Plasma samples were analyzed for treprostinil using a validated bioanalytical plasma assay. Individual and mean treprostinil plasma concentration data and treprostinil pharmacokinetic parameters, such as peak observed plasma concentration (Cmax), time to peak plasma concentration (Tmax), area under the plasma concentration-time curve (AUC0-inf), were determined as able.|Baseline (Cohort 1 only; 0, 4, 8 hours while receiving IV/SC Remodulin) and Week 24 (all cohorts; 0, 2, 4, 6, 8 hours post-dose oral treprostinil)|PK Population. To provide a larger sample size for PK analysis, data for Cohorts 1, 2, and 3 following oral treprostinil administration were combined and compared to parenteral infusion (Cohort 1 Baseline data; Remodulin IV/SC).|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2590979|NCT02276872|Secondary|Observed Minimum Drug Concentration in Plasma (Cmin)|Cohort 1 had three blood samples obtained at 'Time 0' and at 4 and 8 hours at the Baseline visit. All cohorts had five blood samples obtained from at 'Time 0' and at 2, 4, 6, and 8 hours at the Week 24 visit. Plasma samples were analyzed for treprostinil using a validated bioanalytical plasma assay. Individual and mean treprostinil plasma concentration data and treprostinil pharmacokinetic parameters, such as peak observed plasma concentration (Cmax), time to peak plasma concentration (Tmax), area under the plasma concentration-time curve (AUC0-inf), were determined as able.|Baseline (Cohort 1 only; 0, 4, 8 hours while receiving IV/SC Remodulin) and Week 24 (all cohorts; 0, 2, 4, 6, 8 hours post-dose oral treprostinil)|PK Population. To provide a larger sample size for PK analysis, data for Cohorts 1, 2, and 3 following oral treprostinil administration were combined and compared to parenteral infusion (Cohort 1 Baseline data; Remodulin IV/SC).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2590980|NCT02276872|Secondary|Average Drug Concentration in Plasma (Cavg)|Cohort 1 had three blood samples obtained at 'Time 0' and at 4 and 8 hours at the Baseline visit. All cohorts had five blood samples obtained from at 'Time 0' and at 2, 4, 6, and 8 hours at the Week 24 visit. Plasma samples were analyzed for treprostinil using a validated bioanalytical plasma assay. Individual and mean treprostinil plasma concentration data and treprostinil pharmacokinetic parameters, such as peak observed plasma concentration (Cmax), time to peak plasma concentration (Tmax), area under the plasma concentration-time curve (AUC0-inf), were determined as able.|Baseline (Cohort 1 only; 0, 4, 8 hours while receiving IV/SC Remodulin) and Week 24 (all cohorts; 0, 2, 4, 6, 8 hours post-dose oral treprostinil)|PK Population. To provide a larger sample size for PK analysis, data for Cohorts 1, 2, and 3 following oral treprostinil administration were combined and compared to parenteral infusion (Cohort 1 Baseline data; Remodulin IV/SC).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2590981|NCT02276872|Secondary|Last Observed Drug Concentration in Plasma (Clast)|Cohort 1 had three blood samples obtained at 'Time 0' and at 4 and 8 hours at the Baseline visit. All cohorts had five blood samples obtained from at 'Time 0' and at 2, 4, 6, and 8 hours at the Week 24 visit. Plasma samples were analyzed for treprostinil using a validated bioanalytical plasma assay. Individual and mean treprostinil plasma concentration data and treprostinil pharmacokinetic parameters, such as peak observed plasma concentration (Cmax), time to peak plasma concentration (Tmax), area under the plasma concentration-time curve (AUC0-inf), were determined as able.|Baseline (Cohort 1 only; 0, 4, 8 hours while receiving IV/SC Remodulin) and Week 24 (all cohorts; 0, 2, 4, 6, 8 hours post-dose oral treprostinil)|PK Population. To provide a larger sample size for PK analysis, data for Cohorts 1, 2, and 3 following oral treprostinil administration were combined and compared to parenteral infusion (Cohort 1 Baseline data; Remodulin IV/SC).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2590982|NCT02276872|Secondary|Maximum Observed Drug Concentration in Plasma (Cmax)|Cohort 1 had three blood samples obtained at 'Time 0' and at 4 and 8 hours at the Baseline visit. All cohorts had five blood samples obtained from at 'Time 0' and at 2, 4, 6, and 8 hours at the Week 24 visit. Plasma samples were analyzed for treprostinil using a validated bioanalytical plasma assay. Individual and mean treprostinil plasma concentration data and treprostinil pharmacokinetic parameters, such as peak observed plasma concentration (Cmax), time to peak plasma concentration (Tmax), area under the plasma concentration-time curve (AUC0-inf), were determined as able. For the purposes of PK analysis, data for Cohorts 1, 2, and 3 following oral treprostinil administration were combined and compared to parenteral infusion (Cohort 1 Baseline data; Remodulin IV/SC).|Baseline (Cohort 1 only; 0, 4, 8 hours while receiving IV/SC Remodulin) and Week 24 (all cohorts; 0, 2, 4, 6, 8 hours post-dose oral treprostinil)|PK Population. To provide a larger sample size for PK analysis, data for Cohorts 1, 2, and 3 following oral treprostinil administration were combined and compared to parenteral infusion (Cohort 1 Baseline data; Remodulin IV/SC).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2590984|NCT02276872|Secondary|Change From Baseline in Right Ventricular (RV) Mass Index at Week 24|Cardiac MRI imaging was performed in all subjects aged 10 years and older at Baseline and Week 24/Premature Termination; imaging was optionally performed in subjects under the age of 10 years. The subject's BP was taken immediately prior to the cMRI assessment in the supine position to measure vascular parameters.|Baseline and Week 24|Safety Population - Number of Subjects with both Baseline and Week 24 Measurements|||g/m2||Standard Error|Mean
2590985|NCT02276872|Secondary|Change From Baseline in Right Ventricular End-systolic Volume (RVESV) Index at Week 24|Cardiac MRI imaging was performed in all subjects aged 10 years and older at Baseline and Week 24/Premature Termination; imaging was optionally performed in subjects under the age of 10 years. The subject's BP was taken immediately prior to the cMRI assessment in the supine position to measure vascular parameters.|Baseline and Week 24|Safety Population - Number of Subjects with both Baseline and Week 24 Measurements|||mL/m2||Standard Error|Mean
2590986|NCT02276872|Secondary|Change From Baseline in Right Ventricular Ejection Fraction (RVEF) at Week 24|Cardiac MRI imaging was performed in all subjects aged 10 years and older at Baseline and Week 24/Premature Termination; imaging was optionally performed in subjects under the age of 10 years. The subject's BP was taken immediately prior to the cMRI assessment in the supine position to measure vascular parameters.|Baseline and Week 24|Safety Population - Number of Subjects with both Baseline and Week 24 Measurements|||percentage of RVEF||Standard Error|Mean
2590987|NCT02276872|Secondary|Change From Baseline in Right Ventricular End-diastolic Volume (RVEDV) Index at Week 24|Cardiac MRI imaging was performed in all subjects aged 10 years and older at Baseline and Week 24/Premature Termination; imaging was optionally performed in subjects under the age of 10 years. The subject's BP was taken immediately prior to the cMRI assessment in the supine position to measure vascular parameters.|Baseline and Week 24|Safety Population - Number of Subjects with both Baseline and Week 24 Measurements|||mL/m^2||Standard Error|Mean
2590988|NCT02276872|Secondary|Change From Baseline in Right Ventricular (RV) Cardiac Output Index at Week 24|Cardiac MRI imaging was performed in all subjects aged 10 years and older at Baseline and Week 24/Premature Termination; imaging was optionally performed in subjects under the age of 10 years. The subject's BP was taken immediately prior to the cMRI assessment in the supine position to measure vascular parameters.|Baseline and Week 24|Safety Population - Number of Subjects with both Baseline and Week 24 Measurements|||L/min/m2||Standard Error|Mean
2590989|NCT02276872|Secondary|Change From Baseline in Left Ventricular (LV) Stroke Volume Index at Week 24|Cardiac MRI imaging was performed in all subjects aged 10 years and older at Baseline and Week 24/Premature Termination; imaging was optionally performed in subjects under the age of 10 years. The subject's BP was taken immediately prior to the cMRI assessment in the supine position to measure vascular parameters.|Baseline and Week 24|Safety Population - Number of Subjects with both Baseline and Week 24 Measurements|||mL/beat/m2||Standard Error|Mean
2590990|NCT02276872|Secondary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 24|Cardiac MRI imaging was performed in all subjects aged 10 years and older at Baseline and Week 24/Premature Termination; imaging was optionally performed in subjects under the age of 10 years. The subject's BP was taken immediately prior to the cMRI assessment in the supine position to measure vascular parameters.|Baseline and Week 24|Safety Population - Number of Subjects with both Baseline and Week 24 Measurements|||percentage of LVEF||Standard Deviation|Mean
2590991|NCT02276872|Secondary|Change in Plasma N-terminal Pro-B-type Natriuretic Peptide (NT-Pro BNP) From Baseline to Week 24|Plasma NT-proBNP concentration is a useful biomarker for PAH as it is associated with changes in right heart morphology and function.|Baseline and Week 24|Safety Population - Number of Subjects that Completed Study Week 24|||pg/mL||Standard Deviation|Mean
2590992|NCT02276872|Secondary|Change in Quality of Life Assessed Via the Pediatric Quality of Life Inventory (PedsQL) Questionnaire From Baseline to Week 24|Four subscales [items]: (Physical [8], Emotional [5], Social [5], School Functioning [5]). Subjects and subjects' parent(s) completed PedsQL at Week 24. Response to each item on the subscales were graded 0-4 (0=never a problem, 1=almost never a problem, 2=sometimes a problem, 3=often a problem, 4=almost always a problem). Response to each item was transformed from the 0-4 scale to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Using transformed values, mean was computed as sum of the items in each subscale over number of items answered in the same subscale. Two summary scores (Psychosocial Health Summary Score and Total Scale Score) were calculated with a range of 0-100 (higher values indicating better outcome). Psychosocial Health Summary Score was mean computed as sum of the items over the number of items answered in the Emotional, Social, and School Functioning Scales. Total Score was calculated as sum of all items over number of items answered on all the scales.|Baseline and Week 24|Safety Population - Number of Subjects that Completed Study Week 24|||score on a scale||Standard Deviation|Mean
2590993|NCT02276872|Secondary|Change in Borg Dyspnea Score From Baseline to Week 24|The Borg dyspnea score was assessed prior to and following the completion of the 6MWT at Week 24. The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6MWT. Scores range from 0 (for the best condition) to 10 (for the worst condition).|Baseline and Week 24|Safety Population - Number of Subjects that Completed Study Week 24|||score on a scale||Standard Deviation|Mean
2590994|NCT02276872|Secondary|Change in 6-Minute Walk Distance (6MWD) From Baseline to Week 24|The intent of the 6MWT was to evaluate exercise capacity associated with carrying out activities of daily living. Total distance covered in a total of 6 minutes was measured. Oxygen saturation and heart rate (HR) were measured at rest prior to the 6MWT and monitored continuously during the walk. Recovery monitoring (HR and oxygen saturation) was performed and documented at Minute 0 (immediately upon stopping the 6MWT), Minute 1, Minute 2, and Minute 3 post walk.|Baseline and Week 24|Safety Population - Number of Subjects that Completed Study Week 24|||meters||Standard Deviation|Mean
2590995|NCT02276872|Secondary|Change in WHO Functional Class From Baseline to Week 24|Change from Baseline in subject clinical status was recorded according to the WHO Functional Class.|Baseline and Week 24|Safety Population - Number of Subjects that Completed Study Week 24|||Participants|||Count of Participants
2590996|NCT02276872|Secondary|Change in Panama Functional Class From Baseline to Week 24|Change from Baseline in subject clinical status was recorded according to the Panama Functional Class.|Baseline and Week 24|Safety Population - Number of Subjects that Completed Study Week 24|||Participants|||Count of Participants
2605747|NCT02107014|Primary|Change in IL-18 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2590997|NCT02276872|Secondary|Change in Symptoms of PAH From Baseline to Week 24|PAH symptoms (fatigue, dyspnea, edema, dizziness, syncope, chest pain, orthopnea) were assessed at the Baseline Visit prior to the initiation of oral treprostinil dosing and at Week 24. Scores range from 0 (for the best condition) to 3 (for the worst condition).|Baseline and Week 24|Safety Population - Number of Subjects that Completed Study Week 24|||Participants|||Count of Participants
2590998|NCT02276872|Secondary|Cardiopulmonary Exercise Testing - Change From Baseline in Peak Watts at Week 24|Cardiopulmonary Exercise Testing (CPET) was performed with progressive cycle ergometry and ventilatory expired gas analysis obtained using a metabolic cart at Baseline and Week 24/Premature Termination. CPET consisted of measuring oxygen uptake (VO2), carbon dioxide output (VCO2), minute ventilation (VE), and other variables in addition to a 12-lead ECG, blood pressure (BP) monitoring, and pulse oximetry.|Baseline and Week 24|Safety Population - Number of Subjects that Completed Testing at Week 24|||Watts||Standard Deviation|Mean
2590999|NCT02276872|Secondary|Cardiopulmonary Exercise Testing - Change From Baseline in Minute Ventilation (VE)/Carbon Dioxide Output (VCO2) Slope at Week 24|Cardiopulmonary Exercise Testing (CPET) was performed with progressive cycle ergometry and ventilatory expired gas analysis obtained using a metabolic cart at Baseline and Week 24/Premature Termination. CPET consisted of measuring oxygen uptake (VO2), carbon dioxide output (VCO2), minute ventilation (VE), and other variables in addition to a 12-lead ECG, blood pressure (BP) monitoring, and pulse oximetry.|Baseline and Week 24|Safety Population - Number of Subjects that Completed Testing at Week 24|||VE/VCO2 Slope||Standard Deviation|Mean
2591000|NCT02276872|Secondary|Cardiopulmonary Exercise Testing - Change From Baseline in Peak Oxygen Uptake (VO2) at Week 24|Cardiopulmonary Exercise Testing (CPET) was performed with progressive cycle ergometry and ventilatory expired gas analysis obtained using a metabolic cart at Baseline and Week 24/Premature Termination. CPET consisted of measuring oxygen uptake (VO2), carbon dioxide output (VCO2), minute ventilation (VE), and other variables in addition to a 12-lead ECG, blood pressure (BP) monitoring, and pulse oximetry.|Baseline and Week 24|Safety Population - Number of Subjects that Completed Testing at Week 24|||mL/kg/min||Standard Deviation|Mean
2591001|NCT02276872|Primary|Number of Participants With Successful Transition From IV/SC Remodulin to Oral Treprostinil (Cohort 1), From Inhaled Prostacyclin to Oral Treprostinil (Cohort 2), or as an add-on to Current PAH Therapy in de Novo Prostacyclin Subjects (Cohort 3).|A successful transition was defined as a subject from Cohort 1 or Cohort 2 who was receiving oral treprostinil and no longer receiving IV/SC Remodulin or inhaled prostacyclin, respectively, at Week 4 and clinically maintained on oral treprostinil treatment through Week 24. A successful initiation of oral treprostinil for Cohort 3 was defined as a subject who was clinically maintained on oral treprostinil through Week 24.|Up to 24 weeks|Safety Population|||participants|||Number
2591002|NCT02276807|Other Pre-specified|Change From Baseline in the Level of Intensity of Suicidal Ideation at 12 Weeks|The investigators will use the Beck Scale for Suicidal Ideation to assess intensity of suicidal ideation within the past week at baseline and 12 weeks. The minimum score is 0 and the maximum score is 38. Higher scores mean worse suicidal ideation.|Baseline and 12 weeks|Enrolled patients who did not withdraw from the study and completed this assessment at week 12.|||score on a scale||Standard Deviation|Mean
2591003|NCT02276807|Secondary|Change From Baseline in the Level of Reward/Positive Mood When Engaging in Various Experiences at 12 Weeks|The investigators will use the Environmental Observational Reward (EROS) scale to assess level of reward/positive mood at baseline and 12 weeks. The minimum score is 10 and the maximum score is 40. Higher scores mean increased level of positive mood obtained from environment.|Baseline and 12 weeks|Enrolled participants who did not withdraw from the study and completed this assessment measure at week 12.|||score on a scale||Standard Deviation|Mean
2591004|NCT02276807|Secondary|Change From Baseline in Sleep Disturbances at 12 Weeks|The investigators will use the Insomnia Severity Index (ISI) to assess sleep disturbances at baseline and 12 weeks. The minimum score is 0 and the maximum score is 28. Higher scores on ISI mean worse sleep.|Baseline and 12 weeks|Enrolled participants who did not withdraw prior to week 12 and completed this assessment measure at week 12.|||score on a scale||Standard Deviation|Mean
2591005|NCT02276807|Secondary|Change From Baseline in Quality of Life at 12 Weeks|The investigators will use the Short Form-12 (SF-12) mental health domain to assess quality of life at baseline and 12 weeks. The minimum score is 0 and maximum score is 100. Higher scores mean better quality of life within mental health domain.|Baseline and 12 weeks|Enrolled participants who did not withdraw before 12-weeks and completed this questionnaire.|||score on a scale||Standard Deviation|Mean
2591006|NCT02276807|Primary|Change From Baseline in Depressive Symptoms at 12 Weeks|The investigators will use the Patient Health Questionnaire-9 (PHQ-9) to assess depressive symptoms at baseline and 12 weeks. The minimum value is 0 and the maximum value is 27. Higher scores mean a worse outcome.|Baseline and 12 weeks|Participants who did not withdraw before week 12 and completed this questionnaire at week 12|||score on a scale||Standard Deviation|Mean
2591007|NCT02276638|Primary|Percentage Hexagonality|Percentage hexagonality(%HEX) is that Proportion of hexagonal cells found in the analyzed endothelium|single time point - 1 day|Not all participants indicated in the Participant Flow Module were analysed.|||Percentage hexagonality||Standard Deviation|Mean
2591008|NCT02276638|Primary|Center Method Coefficient of Variation of Endothelial Cell Area|Coefficient of variation(CV) is that Standard deviation (SD) divided by the average area of endothelial cell analyzed|single time point - 1 day|Not all participants indicated in the Participant Flow Module were analysed.|||percent of Coefficient of variation||Standard Deviation|Mean
2591009|NCT02276638|Primary|Center Method Corneal Endothelial Cell Density||single time point - 1 day|Not all participants indicated in the Participant Flow Module were analysed.|||cells/mm2||Standard Deviation|Mean
2591010|NCT02276612|Secondary|Change From Baseline in CD4 Percentage at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with on-treatment data were analyzed.|||percentage||Standard Deviation|Mean
2591011|NCT02276612|Secondary|Change From Baseline in CD4 Percentage at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with on-treatment data were analyzed.|||percentage||Standard Deviation|Mean
2591012|NCT02276612|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with on-treatment data were analyzed.|||cells/µL||Standard Deviation|Mean
2591013|NCT02276612|Secondary|Change From Baseline in CD4 Cell Count at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with on-treatment data were analyzed.|||cells/µL||Standard Deviation|Mean
2591014|NCT02276612|Secondary|Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 48 (FDA-defined Snapshot Analysis)|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2591015|NCT02276612|Secondary|Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL at Week 24 (FDA-defined Snapshot Analysis)|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2591016|NCT02276612|Primary|Incidence of Treatment-Emergent Adverse Events|The percentage of participants experiencing any treatment-emergent adverse event was summarized.|Up to Week 48|Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.|||percentage of participants|||Number
2591017|NCT02276612|Primary|Incidence of Treatment-Emergent Serious Adverse Events|The percentage of participants experiencing any treatment-emergent serious adverse event was summarized.|Up to Week 48|Safety Analysis Set: participants who were enrolled in the study and received at least 1 dose of study drug.|||percentage of participants|||Number
2591018|NCT02276560|Primary|Rate of N2 Nodal Clearance|N2 disease is defined as involvement of the ipsilateral mediastinal and/or subcarinal lymph nodes; if disease is cleared form these locations, then there is N2 nodal clearance|3 Months|The only patient registered before funding was withdrawn could not complete treatment due to adverse events.||||||
2591019|NCT02276482|Other Pre-specified|Area Under the Plasma Concentration Versus Time Curve Time 0 to 24 Hours (AUC0-24h) of Tedizolid|AUC0-24h is a measure of the total tedizolid exposure in the plasma from the dose to 24 hours after last dose. AUC0-24h was estimated based on population pharmacokinetic analysis of observed pharmacokinetic data. Blood samples were collected for pharmacokinetic analysis at specific time points.|Day 1 at 5-80 min and 4-12 hrs post-infusion or 2 samples collected between 4-12 hrs after oral dose, at least 60 min apart; at 48-72 hrs: within 60 min prior to administration and 4-12 hrs after administration; and anytime between Day 7 and 9|All randomized participants who received a dose of tedizolid phosphate. Pharmacokinetic analysis was not performed with participants receiving antibiotic comparator drug.|||µg*h/mL||95% Confidence Interval|Geometric Mean
2591020|NCT02276482|Other Pre-specified|Peak Plasma Concentration (Cmax) of Tedizolid|The Cmax of tedizolid in plasma after the last dose was estimated based on population pharmacokinetic analysis of observed pharmacokinetic data. Blood samples were collected for pharmacokinetic analysis at specific time points.|Day 1 at 5-80 minutes (min) and 4-12 hrs post-infusion or 2 samples collected between 4-12 hrs after oral dose, at least 60 min apart; at 48-72 hrs: within 60 min prior to administration and 4-12 hrs after administration; and anytime between Day 7 and 9|All randomized participants who received a dose of tedizolid phosphate. Pharmacokinetic analysis was not performed with participants receiving antibiotic comparator drug.|||µg/mL||95% Confidence Interval|Geometric Mean
2591021|NCT02276482|Other Pre-specified|Change From Baseline in Lesion Size|Lesion size is the area in cm^2 of erythema, edema or induration. A negative number corresponds to a decrease in lesion size.|Baseline and TOC visit (18 to 25 days after infusion)|All randomized participants who received a full dose of study treatment, had a baseline value and a TOC visit value (Days 18 to 25).|||cm^2||Standard Deviation|Mean
2591022|NCT02276482|Secondary|Number of Participants With Investigator's Assessment Indicating Clinical Success at EOT Visit (Clinically Evaluable-End of Therapy [CE-EOT] Analysis Set)|Investigator's assessment of clinical success is defined as (1) resolution or near resolution of most disease-specific signs and symptoms, (2) absence or near resolution of regional or systemic signs of infection (lymphadenopathy, fever, >10% immature neutrophils, abnormal white blood cell count), if present at baseline, and (3) no new signs, symptoms, or complications attributable to the infection under study so no further antibiotic therapy is required for the treatment of the primary lesion.|EOT Visit: up to 13 days after first drug infusion|All randomized participants received a full dose of study treatment and completed EOT.|||Participants|||Count of Participants
2591023|NCT02276482|Secondary|Number of Participants With Investigator's Assessment Indicating Clinical Success at End of Therapy (EOT) Visit (Intent to Treat Analysis Set)|Investigator's assessment of clinical success is defined as (1) resolution or near resolution of most disease-specific signs and symptoms, (2)absence or near resolution of regional or systemic signs of infection (lymphadenopathy, fever, >10% immature neutrophils, abnormal white blood cell count), if present at baseline, and (3) no new signs, symptoms, or complications attributable to the infection under study so no further antibiotic therapy is required for the treatment of the primary lesion.|EOT Visit: up to 13 days after first drug infusion|All randomized participants.|||Participants|||Count of Participants
2591024|NCT02276482|Secondary|Number of Participants With Early Clinical Responses Measured by Lesion Reduction|Early clinical response is defined as ≥20% reduction from baseline lesion area (defined as length multiplied by the width of the erythema, edema, and/or induration [EEI]) at the 48-72 hour (hr) visit.|48-72 hr after first drug infusion|All randomized participants.|||Participants|||Count of Participants
2591025|NCT02276482|Secondary|Number of Participants With Investigator's Assessment Indicating Clinical Success at TOC Visit (Clinically Evaluable-Test of Cure [CE-TOC] Analysis Set)|Investigator's assessment of clinical success is defined as (1) resolution or near resolution of most disease-specific signs and symptoms, (2)absence or near resolution of regional or systemic signs of infection (lymphadenopathy, fever, >10% immature neutrophils, abnormal white blood cell count), if present at baseline, and (3) no new signs, symptoms, or complications attributable to the infection under study so no further antibiotic therapy is required for the treatment of the primary lesion.|TOC Visit: 18-25 days after first drug infusion|All randomized participants who received a full dose of study treatment and completed TOC.|||Participants|||Count of Participants
2593347|NCT02246998|Secondary|PK Parameter: Tmax for TFV||"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the TFV PK Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
2591026|NCT02276482|Secondary|Number of Participants With Investigator's Assessment Indicating Clinical Success at Test of Cure (TOC) Visit (Intent to Treat Analysis Set)|Investigator's assessment of clinical success is defined as (1) resolution or near resolution of most disease-specific signs and symptoms, (2)absence or near resolution of regional or systemic signs of infection (lymphadenopathy, fever, >10% immature neutrophils, abnormal white blood cell count), if present at baseline, and (3) no new signs, symptoms, or complications attributable to the infection under study so no further antibiotic therapy is required for the treatment of the primary lesion.|TOC Visit: 18-25 days after first drug infusion|All randomized participants.|||Participants|||Count of Participants
2591027|NCT02276482|Primary|Number of Participants With Adverse Events on Tedizolid Phosphate and Comparator Drugs|An adverse event (AE) refers to a treatment-emergent adverse event (TE-AE). A TE-AE is any AE that newly appeared, increased in frequency, or worsened in severity following initiation of study drug.|Up to 40 days (including 30-day follow-up)|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2591028|NCT02276274|Secondary|Number of Participants With Laboratory-related Treatment Emergent Adverse Events (TEAEs)|Laboratory assessments included hematology, serum chemistry and urinalysis. Any laboratory-related TEAE reported at any time point were reported in this measure.|3 hours prior to administration (predose), 24 and 72 hours postdose|Safety analysis set: All participants who receive at least one dose of study medication.|||participants|||Number
2591029|NCT02276274|Secondary|Number of Participants With Significant Change From Baseline in Electrocardiograms|Clinically significant change in electrocardiograms observed at any time point are reported.|3 hours prior to administration (predose) and 2, 24 and 72 hours postdose|Safety analysis set: All participants who receive at least one dose of study medication.|||participants|||Number
2591030|NCT02276274|Secondary|Number of Participants With Clinically Significant Change From Baseline in Body Weight|Clinically significant change participant's body weight observed at any time point are reported.|3 hours prior to administration (predose), 24 and 72 hours postdose|Safety analysis set: All participants who receive at least one dose of study medication.|||participants|||Number
2591031|NCT02276274|Secondary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature (infra-axillary), supine blood pressure resting more than 5 minutes (systolic and diastolic [Millimeters of mercury]), respiratory rate and pulse (beats per minute). Clinically significant change in vital signs observed at any time point are reported.|3 hours prior to administration (predose) and 2, 24 and 72 hours postdose|Safety analysis set: All participants who receive at least one dose of study medication.|||participants|||Number
2591032|NCT02276274|Secondary|Number of Participants Reporting 1 or More Treatment-emergent Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to the day of discharge (Day 4) in the second intervention period|Safety analysis set: All participants who receive at least one dose of study medication.|||participants|||Number
2591033|NCT02276274|Secondary|Tmax: Time to Reach Emax|Time to reach Emax for the first time was determined from the inhibition-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.|||hour||Full Range|Median
2591034|NCT02276274|Secondary|Emax: Maximum Inhibition Rate of Plasma DPP-4 Activity|Maximum inhibition rate of plasma DPP-4 activity was determined from the inhibition-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.|||percentage of inhibition||Standard Deviation|Mean
2591035|NCT02276274|Secondary|AUC (0-24): Area Under the Inhibition Rate of Plasma DPP-4 Activity-time Curve From Time 0 to 24 Hours|Area under the inhibition rate of plasma DPP-4 activity-time curve from time 0 to 24 hours was determined from the inhibition-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.|||percentage of inhibition*hour||Standard Deviation|Mean
2591036|NCT02276274|Secondary|DPP-4 Activity|DPP-4 activity was assessed from the plasma samples collected from the participants.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.|||nanomole/minute/milliliter (nmoL/min/mL)||Standard Deviation|Mean
2591037|NCT02276274|Secondary|Inhibition Rate of Dipeptidyl-peptidase-4 (DPP-4) Activity|DPP-4 activity and inhibition rate of DPP-4 activity was assessed from the plasma samples collected from the participants. Inhibition of DPP-4 enzyme was used to determine the antihyperglycemic activity of the investigational product.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours postdose|Pharmacodynamic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacodynamics.|||percentage of inhibition||Standard Deviation|Mean
2591038|NCT02276274|Primary|CLr: Renal Clearance of Metformin|CLr is a measure of apparent clearance of the drug from the urine.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||L/hr||Standard Deviation|Mean
2594342|NCT02233738|Secondary|SF-12 Health Survey Mental Summary Score at 6 Months|Mental summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health|6 months||||score on a scale||Standard Deviation|Mean
2591039|NCT02276274|Primary|CLr: Renal Clearance of SYR-322Z|CLr is a measure of apparent clearance of the drug from the urine. The clearance is the rate at which waste substances are cleared from the blood.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||L/hr||Standard Deviation|Mean
2591040|NCT02276274|Primary|Urinary Excretion Ratio of Metformin From 0 to 48 Hours Postdose|Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.|0 to 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
2591041|NCT02276274|Primary|Urinary Excretion Ratio of Metformin From 0 to 24 Hours Postdose|Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.|0 to 24 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
2591042|NCT02276274|Primary|Urinary Excretion Ratio of Metformin From Time 0 to 12 Hours Postdose|Cumulative urinary excretion ratio of metformin was calculated as the percentage of metformin dose.|0 to 12 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
2591043|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 72 Hours Postdose|Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.|0 to 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
2591044|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 48 Hours Postdose|Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.|0 to 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
2591045|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 24 Hours Postdose|Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.|0 to 24 hours post dose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
2591046|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322 Metabolites M-I and M-II From 0 to 12 Hours Postdose|Cumulative urinary excretion ratio of SYR-322 metabolites M-I and M-II was calculated as the percentage of SYR-322 dose.|0 to 12 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
2591047|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322Z From 0 to 72 Hours Postdose|Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.|0 to 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
2591048|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322Z From 0 to 48 Hours Postdose|Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.|0 to 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
2591049|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322Z From 0 to 24 Hours Postdose|Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.|0 to 24 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
2591050|NCT02276274|Primary|Urinary Excretion Ratio of SYR-322Z From 0 to 12 Hours Postdose|Cumulative urinary excretion ratio of unchanged SYR-322 was calculated as the percentage of SYR-322 dose.|0 to 12 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||percentage of dose||Standard Deviation|Mean
2591051|NCT02276274|Primary|Mean Residence Time (MRT) for Metformin|Mean residence time (MRT) calculated as area under the first moment plasma concentration-time curve (AUMC [0-inf]) divided by AUC (0-inf). AUMC (0-inf) is the area under the first moment plasma concentration-time curve from time 0 to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hr||Standard Deviation|Mean
2591052|NCT02276274|Primary|Apparent Clearance After Extra Vascular Administration (CL/F) for Metformin|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in L/hr.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||L/hr||Standard Deviation|Mean
2591109|NCT02275780|Secondary|Percentage of Participants With Any Drug-related Serious Adverse Event|The percentage of participants with any drug-related SAE was assessed.|Up to 98 weeks|All randomized participants who received at least 1 dose of study drug|||Percentage of Participants|||Number
2591053|NCT02276274|Primary|Terminal Phase Elimination Half-life (T1/2) for Metformin|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hr||Standard Deviation|Mean
2591054|NCT02276274|Primary|Apparent Terminal Elimination Rate Constant (λz) for Metformin|Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hr^-1||Standard Deviation|Mean
2591055|NCT02276274|Primary|AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Metformin|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
2591056|NCT02276274|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Metformin|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hr||Full Range|Median
2591057|NCT02276274|Primary|Cmax: Maximum Observed Plasma Concentration for Metformin|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||ng/mL||Standard Deviation|Mean
2591058|NCT02276274|Primary|MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for Metformin|MRT (0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT (0-tlqc) =AUMC (0-tlqc)/AUC (0-tlqc). AUMC (0-tlqc) is the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: Subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hr||Standard Deviation|Mean
2591059|NCT02276274|Primary|AUC (0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Metformin|AUC (0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC [0-tlqc]).|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
2591060|NCT02276274|Primary|AUC (0-48): Area Under the Plasma Concentration-time Curve From Time 0 to 48 Hours Postdose for Metformin|AUC (0-48) is measure of area under the curve from time 0 to 48 hours post dose.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
2591061|NCT02276274|Primary|Mean Residence Time (MRT) for SYR-322 Metabolites M-I and M-II|Mean residence time (MRT) calculated as area under the first moment plasma concentration-time curve (AUMC [0-inf]) divided by AUC (0-inf). AUMC (0-inf) is the area under the first moment plasma concentration-time curve from time 0 to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.|||hr||Standard Deviation|Mean
2591062|NCT02276274|Primary|Terminal Phase Elimination Half-life (T1/2) for SYR-322 Metabolites M-I and M-II|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.|||hr||Standard Deviation|Mean
2591063|NCT02276274|Primary|Apparent Terminal Elimination Rate Constant (λz) for SYR-322 Metabolites M-I and M-II|Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.|||hr^-1||Standard Deviation|Mean
2591085|NCT02276222|Primary|Number of Subjects Who Discontinue the Study Due to TEAE|A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.|Up to Week 48|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||participants|||Number
2591064|NCT02276274|Primary|AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for SYR-322 Metabolites M-I and M-II|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.|||ng*hr/mL||Standard Deviation|Mean
2591065|NCT02276274|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for SYR-322 Metabolites M-I and M-II|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.|||hr||Full Range|Median
2591066|NCT02276274|Primary|Cmax: Maximum Observed Plasma Concentration for SYR-322 Metabolites M-I and M-II|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.|||ng/mL||Standard Deviation|Mean
2591067|NCT02276274|Primary|MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for SYR-322 Metabolites M-I and M-II|MRT (0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT (0-tlqc) =AUMC (0-tlqc)/AUC (0-tlqc). AUMC (0-tlqc) is the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.|||hr||Standard Deviation|Mean
2591068|NCT02276274|Primary|AUC (0-tlqc): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for SYR-322 Metabolites M-I and M-II|AUC (0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC [0-tlqc]).|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.|||ng*hr/mL||Standard Deviation|Mean
2591069|NCT02276274|Primary|AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post Dose for SYR-322 Metabolites M-I and M-II|AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics of each of the SYR-322 metabolites.|||ng*hr/mL||Standard Deviation|Mean
2591070|NCT02276274|Primary|MRT (0-tlqc): Mean Residence Time From Time 0 to Time of the Last Quantifiable Concentration (Tlqc) for SYR-322Z|MRT (0-tlqc) is a measure of the mean residence time from time 0 to time of the last quantifiable concentration (tlqc) calculated as MRT (0-tlqc) =AUMC (0-tlqc)/AUC (0-tlqc). AUMC (0-tlqc) is the area under the first moment plasma concentration-time curve from time 0 to time of the last quantifiable concentration (tlqc), calculated using the linear trapezoidal rule.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic analysis set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hr||Standard Deviation|Mean
2591071|NCT02276274|Primary|Mean Residence Time (MRT) for SYR-322Z|Mean residence time (MRT) calculated as area under the first moment plasma concentration-time curve (AUMC [0-inf]) divided by AUC (0-inf). (AUMC [0-inf]) is the area under the first moment plasma concentration-time curve from time 0 to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hr||Standard Deviation|Mean
2591072|NCT02276274|Primary|Apparent Clearance After Extra Vascular Administration (CL/F) for SYR-322Z|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in liter/hour (L/hr).|3 hours prior to administration, and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours after administration|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||L/hr||Standard Deviation|Mean
2591073|NCT02276274|Primary|Terminal Phase Elimination Half-life (T1/2) for SYR-322Z|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hr||Standard Deviation|Mean
2591074|NCT02276274|Primary|Apparent Terminal Elimination Rate Constant (λz) for SYR-322Z|Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hr^-1||Standard Deviation|Mean
2591075|NCT02276274|Primary|AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for SYR-322Z|AUC (0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
2591076|NCT02276274|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for SYR-322Z|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||hour (hr)||Full Range|Median
2591077|NCT02276274|Primary|Cmax: Maximum Observed Plasma Concentration for SYR-322Z|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||ng/mL||Standard Deviation|Mean
2591078|NCT02276274|Primary|AUC (0-tlqc): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for SYR-322Z|AUC (0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC [0-tlqc]).|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||ng*hr/mL||Standard Deviation|Mean
2591079|NCT02276274|Primary|AUC (0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Postdose for Unchanged SYR-322 (SYR-322Z)|AUC (0-72) is measure of area under the curve from time 0 to 72 hours post dose.|3 hours prior to administration (predose) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours postdose|Pharmacokinetic set: subset of participants who received the investigational product, satisfied the minimum requirements of the protocol with no significant deviations, and were assessable for pharmacokinetics.|||nanogram*milliliter per hour (ng*hr/mL)||Standard Deviation|Mean
2591080|NCT02276222|Secondary|Mean Change From Baseline Over 48 Weeks in Trough FEV1 for All Subjects|"Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the average of the FEV1 values collected at the end of the dosing interval at each clinic visit. The mean change from baseline in trough FEV1 over the 48 week treatment period is calculated by averaging the trough FEV1 changes from baseline across all study visits while subjects are taking randomized treatment.~Values affected by other medication use were to be set to missing."|Up to Week 48|Intent to Treat (ITT) Population: all subjects who were randomized to treatment and received at least one dose of study medication. Subjects were analyzed based on the treatment they were randomized to.|||liters||Standard Error|Least Squares Mean
2591081|NCT02276222|Secondary|Incidence Rate Per 1000 Person Years of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke|"All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs myocardial infarction, other ischemic heart disease, central nervous system hemorrhages and cerebrovascular conditions) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact."|up to week 48|Incidence rate: TT= Total Time in years. Total Time (TT) is defined as the time from the first date of study drug until the latter of the date of last contact or 30 days after the date of last dose. Incidence Rate (per 1000 person-years) = n/TT x 1000.|||event per 1000 person years|||Number
2591082|NCT02276222|Secondary|Percentage of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke|"All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs myocardial infarction, other ischemic heart disease, central nervous system hemorrhages and cerebrovascular conditions) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact."|Up to 48 Weeks|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||percentage of participants|||Number
2591083|NCT02276222|Secondary|Number of Subjects With Major Adverse Cardiac Events (MACE), Including Cardiovascular Death, Ischemia/Infarction, and Stroke|"All deaths and any other findings suggestive of a potential MACE (including clinically relevant information and SAEs, and all PTs form the SMQs myocardial infarction, other ischemic heart disease, central nervous system hemorrhages and cerebrovascular conditions) were sent to an adjudication committee for review and categorized as CV death, nonfatal MI, and nonfatal stroke. The MACE score was defined as the total number of subjects with CV deaths, nonfatal MIs, and nonfatal strokes. These events were collected from the first date of study medication until the date of last contact."|Up to Week 48|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||participants|||Number
2591084|NCT02276222|Primary|Percentage of Subjects Who Discontinue the Study Due to TEAE|A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.|Up to 48 Weeks|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||percentage of participants|||Number
2593561|NCT02244918|Primary|Smoking Abstinence|Biochemically confirmed 30-day point prevalence abstinence at Week 12 using urine anabasine and anatabine, with the recommended cut-off of 2 ng/ml to differentiate smokers from non-smokers.|Week 12||||Participants|||Count of Participants
2591086|NCT02276222|Primary|Percentage of Subjects With Treatment-emergent Serious Adverse|A treatment emergent serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.|Up to Week 48|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||percentage of participants|||Number
2591087|NCT02276222|Primary|Number of Subjects With Treatment-emergent Serious Adverse Events (SAE)|A treatment emergent serious adverse event (SAE) is any SAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any SAE with both a missing start and stop date.|Up to Week 48|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||participants|||Number
2591088|NCT02276222|Primary|Percentage of Subjects With Treatment-emergent Adverse Events|A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.|Up to Week 48|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||percentage of participants|||Number
2591089|NCT02276222|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAE)|A TEAE is any adverse event (AE) that occurred on or after the first dose of study medication, any AE with a missing start date and a stop date on or after the first dose of study medication, or any AE with both a missing start and stop date.|Up to Week 48|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||participants|||Number
2591090|NCT02276053|Secondary|Clinical Global Impression of Change (CGIC) Rating at Visit 3 (Month 6 or End of Observation Period)|"The Clinical Global Impression of Change is a seven-point scale for the treating physician to rate the patient's general health status at the end of the study compared to how the patient felt before entering the study. Scores 1 to 3 mean improvement, score 4 means no change, and scores 5 to 7 mean worsening.~The category 'Improved' represents the sum of Very Much Improved, Much Improved, and Minimally Improved.~The category 'Worsened' represents the sum of Minimally Worse, Much Worse, and Very Much Worse."|Visit 3 (Month 6 or end of Observation Period)|The analysis was performed on the Full Analysis Set (FAS), which included all patients in the Safety Set (SS) who had at least 1 post Baseline Patient Global Impression of Change (PGIC) or seizure assessment.|||Participants|||Count of Participants
2591091|NCT02276053|Secondary|Discontinuation Rate of Lacosamide (LCM) Due to Lack of Effectiveness|Discontinuation rate due to lack of effectiveness is the number of patients that discontinued from the study and from LCM treatment due to lack of effectiveness during the 6 months of observation.|Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)|The analysis was performed on the Safety Set (SS), which included all patients who received treatment with lacosamide (LCM) at least once in the study.|||Participants|||Count of Participants
2591092|NCT02276053|Secondary|Discontinuation Rate of Lacosamide (LCM) Due to Adverse Drug Reactions (ADRs)|Discontinuation rate due to ADRs is the number of patients that discontinued from the study and from LCM treatment due to ADRs during the 6 months of observation.|Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)|The analysis was performed on the Safety Set (SS), which included all patients who received treatment with lacosamide (LCM) at least once in the study.|||Participants|||Count of Participants
2591093|NCT02276053|Secondary|Percentage of Patients With Seizure-free Status (Yes/No) at the End of the 6-month Observational Period|Percentage of patients achieving a seizure-free status at the end of the 6-month Observation Period.|Visit 3 (Month 6 or end of Observation Period)|The analysis was performed on the Full Analysis Set (FAS), which included all patients in the Safety Set (SS) who had at least 1 post Baseline Patient Global Impression of Change (PGIC) or seizure assessment.|||percentage of patients||95% Confidence Interval|Number
2591094|NCT02276053|Secondary|Percentage Change From Baseline in Seizure Frequency|The percentage change from Baseline to Month 6 in seizure frequency is the actual change in seizure frequency for this period compared to the Baseline seizure frequency, which is considered 100 %.|Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)|The analysis was performed on the Full Analysis Set (FAS), which included all patients in the Safety Set (SS) who had at least 1 post Baseline Patient Global Impression of Change (PGIC) or seizure assessment.|||percent change||Inter-Quartile Range|Median
2591095|NCT02276053|Secondary|Actual Change From Visit 1 (Baseline) to Visit 3 (Month 6 or End of Observation Period) in Seizure Frequency (Seizures Per 28 Days)|"The actual change in seizure frequency from Baseline to Month 6 is calculated as the seizure frequency at Month 6 minus the seizure frequence at Baseline.~The seizure frequency at each time point is calculated as number of seizures per 28 days."|Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)|The analysis was performed on the Full Analysis Set (FAS), which included all patients in the Safety Set (SS) who had at least 1 post Baseline Patient Global Impression of Change (PGIC) or seizure assessment.|||seizures per 28 days||Inter-Quartile Range|Median
2591096|NCT02276053|Secondary|Change From Visit 1 (Baseline) to Visit 3 (Month 6 or End of Observation Period) in the M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)|MDASI-BT is a 2-part patient completed questionnaire where patients have to answer 22 questions about their brain tumor-related symptoms and 6 questions about how these symptoms interfere with their life. The mean core symptom severity is derived as the mean of the 13 core symptom items, the mean module symptom severity is derived as the mean of the 9 brain tumor specific symptom items and the mean total symptom severity is derived as the mean of all 22 symptom items. The mean interference is derived as the mean of the 6 interference items. For each score, at least 50% of the items needs to be answered for the score to be calculated. Mean core, mean module and mean total symptom severity scores are ranging from 0 to 10 (0=not present 10=as bad as you can imagine). Mean interference score is ranging from 0 to 10 (0= did not interfere 10= interfered completely). The Change from Baseline is calculated, negative values indicate improvement, positive values indicate worsening.|Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)|The analysis was performed on the Full Analysis Set (FAS), which included all patients in the Safety Set (SS) who had at least 1 post Baseline Patient Global Impression of Change (PGIC) or seizure assessment.|||scores on a scale||Standard Deviation|Mean
2593562|NCT02244840|Secondary|Convenience|Questionnaires|3 minute|||||||
2591097|NCT02276053|Secondary|Change From Visit 1 (Baseline) to Visit 3 (Month 6 or End of Observation Period) in the 5 Level EuroQol-5 Dimension Quality of Life Assessment (EQ-5D-5L) Change in Utility as Converted From the 5 Dimensions|EQ-5D-5L: 5 Level EuroQol-5 descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression with five response levels for each dimension: no problems, slight problems, moderate problems, severe problems and extreme problems. This 5-dimension health status is converted into a numerical utility value using the UK value set, as per EuroQOL guidelines. The utility score ranges from 0 to 1 (0=worst imaginable health state, 1=best imaginable health state). The Change from Baseline is calculated for this endpoint, negative values indicate worsening and positive values indicate improvement.|Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)|The analysis was performed on the Full Analysis Set (FAS), which included all patients in the Safety Set (SS) who had at least 1 post Baseline Patient Global Impression of Change (PGIC) or seizure assessment.|||scores on a scale||Standard Deviation|Mean
2591098|NCT02276053|Secondary|Change From Visit 1 (Baseline) to Visit 3 (Month 6 or End of Observation Period) in the 5 Level EuroQol-5 Dimension Quality of Life Assessment (EQ-5D-5L) Visual Analogue Scale (VAS) Score|EQ-5D-5L: 5 Level EuroQol-5 Dimension Quality of Life Assessment is a patient-completed questionnaire for patients to rate their quality of life status in five questions and a 0 (no pain) - 100 (worst pain) score vertical visual analogue scale. The Change from Baseline is calculated for this endpoint, negative values indicate improvement and positive values indicate worsening.|Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)|The analysis was performed on the Full Analysis Set (FAS), which included all patients in the Safety Set (SS) who had at least 1 post Baseline Patient Global Impression of Change (PGIC) or seizure assessment.|||scores on a scale||Standard Deviation|Mean
2591099|NCT02276053|Secondary|Time to Discontinuation of Lacosamide (LCM) Treatment From the Date of First Dose of LCM|Time between first dose of LCM to discontinuation of LCM treatment was measured in days.|From first dose to discontinuation, over a 6-month Observation Period|The analysis was performed on the Safety Set (SS), which included all patients who received treatment with lacosamide (LCM) at least once in the study.|||days||95% Confidence Interval|Median
2591100|NCT02276053|Secondary|Percentage of Patients With Retention on Lacosamide (LCM) at the End of the 6-month Observation Period|The retention rate was defined as the percentage of patients remaining in the study and on Lacosamide treatment for 6 months (6 month retention rate).|Visit 3 (Month 6 or end of Observation Period)|The analysis was performed on the Safety Set (SS), which included all patients who received treatment with lacosamide (LCM) at least once in the study.|||percentage of patients|||Number
2591101|NCT02276053|Primary|Patient Global Impression of Change (PGIC) Rating at Visit 3|"The Patient Global Impression of Change scale is a seven-point scale for patients to rate their general health status at the end of the study compared to how they felt before entering the study. Scores 1 to 3 mean improvement, score 4 means no change, and scores 5 to 7 mean worsening.~The category 'Improved' represents the sum of Very Much Improved, Much Improved, and Minimally Improved.~The category 'Worsened' represents the sum of Minimally Worse, Much Worse, and Very Much Worse."|Visit 3 (Month 6 or end of Observation Period)|The analysis was performed on the Full Analysis Set (FAS), which included all patients in the Safety Set (SS) who had at least 1 post Baseline Patient Global Impression of Change (PGIC) or seizure assessment.|||Participants|||Count of Participants
2591102|NCT02276053|Primary|Percentage of Patients With Response at the End of the 6-month Observation Period|A responder is a patient experiencing a 50 % or greater reduction in partial onset seizure frequency from Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)|Visit 1 (Baseline) to Visit 3 (Month 6 or end of Observation Period)|The analysis was performed on the Full Analysis Set (FAS), which included all patients in the Safety Set (SS) who had at least 1 post Baseline Patient Global Impression of Change (PGIC) or seizure assessment.|||percentage of patients||95% Confidence Interval|Number
2591103|NCT02276040|Primary|Change in Blood Serum Levels of Bupivocaine From Baseline|Bupivocaine levels measured in the blood that is collected in a surgical drain post surgery. Blood samples will be tested for change in serum bupivicaine levels from baseline.|Change from baseline at 2 and 5 hours post-dose||||ug/cc||Inter-Quartile Range|Median
2591104|NCT02275923|Primary|Change in Subcutaneous Impedance|The change in impedance from the beginning to the end of a dialysis session, averaged over all patients and dialysis sessions|24 days|Patients implanted with a LINQ having at least one dialysis session between 7 and 30 days post-implant|||ohm||Standard Deviation|Mean
2591105|NCT02275923|Primary|Average Fluid Volume Removed|The average fluid volume removal during the dialysis session over all patients.|24 Days|Enrolled patients implanted with a LINQ device that had at least one dialysis session between 7 and 30 days post-implant. Formal statistical analysis was not performed because the likelihood from the pre-specified model did not converge due to small sample size. Average fluid loss is summarized instead.|||mL||Standard Deviation|Mean
2591106|NCT02275780|Secondary|Percentage of Participants Achieving Plasma HIV-1 RNA <40 Copies/mL at Week 96|"The percentage of participants in each arm achieving HIV-1 RNA levels <40 copies/mL at Week 96 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach and all missing data were considered treatment failures, regardless of the reason."|Week 96|All randomized participants who received at least 1 dose of study drug and had data for the outcome measure. Participants with missing HIV-1 RNA due to an Abbott RealTime manufacturing agent recall were excluded from the analysis.|||Percentage of participants|||Number
2591107|NCT02275780|Secondary|Percentage of Participants Achieving Plasma HIV-1 RNA <40 Copies/mL at Week 48|"The percentage of participants in each arm achieving HIV-1 RNA levels <40 copies/mL at Week 48 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach and all missing data were considered treatment failures, regardless of the reason."|Week 48|All randomized participants who received at least 1 dose of study drug|||Percentage of participants|||Number
2591108|NCT02275780|Secondary|Percentage of Participants Who Discontinued Study Treatment Due to an Adverse Event|The percentage of participants who discontinued study treatment due to an AE was assessed.|Up to 96 weeks|All randomized participants who received at least 1 dose of study drug|||Percentage of Participants|||Number
2593563|NCT02244840|Primary|Anal Resting Pressure Change|before and after bidet/sitz bath for 3 minute|3 minute||||mmHg||Standard Deviation|Mean
2591110|NCT02275780|Secondary|Percentage of Participants With Any Drug-related Adverse Event|The investigator was to determine if an AE had a reasonable possibility of a relationship to the study drug. The percentage of participants with any drug-related AE was assessed.|Up to 98 weeks|All randomized participants who received at least 1 dose of study drug|||Percentage of Participants|||Number
2591111|NCT02275780|Secondary|Percentage of Participants With Any Serious Adverse Event|A serious adverse event is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose, or is another important medical event. The percentage of participants with any SAE was assessed.|Up to 98 weeks|All randomized participants who received at least 1 dose of study drug|||Percentage of Participants|||Number
2591112|NCT02275780|Secondary|Percentage of Participants With Any Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a study participant and which does not necessarily have to have a causal relationship to treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the study treatment or protocol-specified procedure, whether or not considered related to study treatment or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study treatment is also an AE. The percentage of participants with any AE was assessed.|Up to 98 weeks|All randomized participants who received at least 1 dose of study drug|||Percentage of Participants|||Number
2591113|NCT02275780|Secondary|Mean Change From Baseline in Fasting Triglyceride at Week 48|Serum triglyceride was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy.|Baseline and Week 48|All randomized participants who received at least 1 dose of study drug and had a measurement at Baseline and at the time point assessed.|||mg/dL||Standard Deviation|Mean
2591114|NCT02275780|Secondary|Mean Change From Baseline in Fasting Total Cholesterol at Week 48|Serum total cholesterol was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy.|Baseline and Week 48|All randomized participants who received at least 1 dose of study drug and had a measurement at Baseline and at the time point assessed.|||mg/dL||Standard Deviation|Mean
2591115|NCT02275780|Secondary|Mean Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 48|Serum HDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy.|Baseline and Week 48|All randomized participants who received at least 1 dose of study drug and had a measurement at Baseline and at the time point assessed.|||mg/dL||Standard Deviation|Mean
2591116|NCT02275780|Secondary|Mean Change From Baseline in Fasting Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 48|Serum non-HDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The LOCF approach was applied for missing data or data collected after modifying lipid-lowering therapy.|Baseline and Week 48|All randomized participants who received at least 1 dose of study drug and had a measurement at Baseline and at the time point assessed.|||mg/dL||Standard Deviation|Mean
2591117|NCT02275780|Secondary|Mean Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 48|Serum LDL-C was determined after an overnight fast. Change from Baseline was analyzed using ANCOVA models with terms for Baseline lipid level and treatment group. The Last Observation Carry Forward (LOCF) approach was applied for missing data or data collected after modifying lipid-lowering therapy.|Baseline and Week 48|All randomized participants who received at least 1 dose of study drug and had a measurement at Baseline and at the time point assessed.|||mg/dL||Standard Deviation|Mean
2591118|NCT02275780|Secondary|Change From Baseline in Mean CD4+ T-cell Count at Week 96|CD4+ T-cell counts were quantified by a central laboratory using a commercially available assay.|Baseline and Week 96|All randomized participants who received at least 1 dose of study drug and had data for the outcome measure. Baseline values were carried forward for participants who discontinued therapy due to lack of efficacy.|||Cells/mm^3||95% Confidence Interval|Mean
2591119|NCT02275780|Secondary|Change From Baseline in Mean CD4+ T-cell Count at Week 48|CD4+ T-cell counts were quantified by a central laboratory using a commercially available assay.|Baseline and Week 48|All randomized participants who received at least 1 dose of study drug and had data for the outcome measure. Baseline values were carried forward for participants who discontinued therapy due to lack of efficacy.|||Cells/mm^3||95% Confidence Interval|Mean
2591120|NCT02275780|Secondary|Percentage of Participants Achieving Plasma HIV-1 RNA <50 Copies/mL at Week 96|"The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL at Week 96 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach and all missing data were considered treatment failures, regardless of the reason."|Week 96|All randomized participants who received at least 1 dose of study drug and had data for the outcome measure. Participants with missing HIV-1 RNA due to an Abbott RealTime manufacturing agent recall were excluded from the analysis.|||Percentage of participants|||Number
2591121|NCT02275780|Primary|Percentage of Participants Achieving Plasma HIV-1 RNA <50 Copies/mL at Week 48|"The percentage of participants in each arm achieving HIV-1 RNA levels <50 copies/mL at Week 48 was determined. Plasma HIV-1 RNA levels were quantified with the Abbott RealTime HIV-1 Assay. Data were handled according to the US Food and Drug Administration (FDA) snapshot approach and all missing data were considered treatment failures, regardless of the reason."|Week 48|All randomized participants who received at least 1 dose of study drug|||Percentage of participants|||Number
2591122|NCT02275767|Secondary|% Residual Graft Material (Histological)|histologic determination of % residual graft material 18-20 weeks after ridge preservation surgery|18-20 weeks after ridge preservation||||percentage of total area||Standard Deviation|Mean
2591123|NCT02275767|Primary|% Vital Bone Formation (Histological)|histologic determination of % vital bone formation 18-20 weeks after ridge preservation surgery|18-20 weeks after ridge preservation||||percentage of total area||Standard Deviation|Mean
2591124|NCT02275611|Secondary|Change in Percentage Heavy Drinking Days|A heavy drinking day is defined by consumption of 5 or more standard drinks for men, 4 or more standard drinks for women. The outcome measure is the change in percentage of heavy drinking days as determine by the Timeline Followback interview between the baseline 90 day period and the first 4 weeks of intranasal test treatment in the outpatient setting.|90 days prior to admission and 4 weeks in the outpatient setting|This assessment was done only in the outpatient phase.|||percentage of heavy drinking days change||Standard Deviation|Mean
2591125|NCT02275611|Secondary|Total mg of Lorazepam for Detoxification|"Cumulative lorazepam received (2 mg doses)~After initiation of test treatments, CIWA scores and vital signs were obtained every 4 hours or whenever subjects or staff reported/observed significant increases in symptoms. Lorazepam (2 mg dose) was given if CIWA scores were >7, diastolic blood pressure rose to >120, or heart rate rose to >110. An additional 2 mg was given 1 hour after each lorazepam dose if CIWA scores and/or vital signs remained elevated."|48 hours after initiation of intranasal test doses|This assessment was done only in the inpatient withdrawal phase.|||cumulative lorazepam doses (mg)||Standard Deviation|Mean
2591126|NCT02275611|Primary|Change in Clinical Institute Withdrawal Assessment for Alcohol (CIWA) Score|The Clinical Institute Withdrawal Assessment for Alcohol (CIWA) measure is a ten item measure of alcohol withdrawal symptoms. The CIWA total score is the summation of 10 questions, with a range from 0 (little to no withdrawal) to 67 (worse alcohol withdrawal).|Change in scores from before initiation of intranasal test treatment and the first 48 hours after initiation of intranasal test treatments|This assessment was done only in the inpatient withdrawal phase.|||units on a scale||Standard Deviation|Mean
2591127|NCT02275546|Primary|Percentage of Participants With Vaginal Ring Expulsion Within 48 Hours of Insertion|Participants completed a Follow-Up Questionnaire in which they asked if they experienced vaginal ring expulsion. Their answers were recorded and evaluated.|Up to 48 hours after vaginal ring insertion|Per Protocol Population, which excluded participants due to important deviations from the protocol that could have substantially affected the results of the efficacy endpoints.|||Percentage of participants||95% Confidence Interval|Number
2591128|NCT02275546|Primary|Percentage of Participants With Successful Ring Insertion|Participants completed a Post-Insertion Questionnaire in which they were asked about their experience inserting the vaginal ring. Their answers were recorded and evaluated.|Day 1 (immediately after vaginal ring insertion)|Per Protocol Population, which excluded participants due to important deviations from the protocol that could have substantially affected the results of the efficacy endpoints.|||Percentage of participants||95% Confidence Interval|Number
2591129|NCT02275481|Primary|Number of Participants Experiencing All-cause Hospitalization or Emergency Department Visit Within 90-days of Initiating Treatment|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only summary tables and listings, disposition, demographics, vital signs, AEs and listings of safety data were generated.|Up to 90 days|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol.||||||
2591130|NCT02275364|Secondary|VNR: Change From Baseline to 20 Minutes After Decongestant Administration, and Post Application of the Marketed Nasal Strip After Decongestant Administration|Participants provided their response for VNR on a scale of 0 to 10 (0 = Breathe Freely and 10 = Totally Blocked) how easy it was to breathe through nose at a given time.|Upto 2 hours|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 2 participants didn't meet the standards.|||Units on a scale||Standard Deviation|Mean
2591131|NCT02275364|Secondary|Verbal Numerical Response (VNR): Change From Baseline to Immediately After Strip Application and 30 Minutes Post Application|Participants provided their response for VNR on a scale of 0 to 10 (0 = Breathe Freely and 10 = Totally Blocked) how easy it was to breathe through nose at a given time.|Upto 30 minutes|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 2 participants didn't meet the standards.|||Units on a scale||Standard Deviation|Mean
2591132|NCT02275364|Secondary|Breathing-related Cortical Activity (Blood Oxygen Level Dependent- Resting State)|"Regional measures of breathing-related cortical activity were derived by determining Functional Connectivity and Event-related percentage signal change.~Functional connectivity analyzes of fMRI data where spontaneous (i.e. while the participant is at rest) signal changes in one brain region are regressed against other regions, to identify regions sharing similar functional properties.~Event-related functional magnetic resonance imaging (efMRI) detects changes in the BOLD hemodynamic response to neural activity associated with certain event. In this case, the events were pre-defined by collecting additional data during the scan; participant respiration was determined using a simple pressure-sensitive respiration belt. Events time-locked to peak inspiration and expiration were defined separately, and regressed against brain activity, showing brain regions that were more or less active during each event type."|Upto 2.5 hours|Decongestant and Test Nasal Strip Plus Decongestant groups were not included in this outcome measure as it was prespecified to evaluate the effect on nasal strips on the breathing related brain activity without the use of nasal decongestant|||% signal change||Standard Deviation|Mean
2591133|NCT02275364|Primary|Functional Measure: Blood Oxygen Level Dependent- Interoceptive Attention Task (Psychophysiological Interactive Analysis)|Regional measures of functional brain activity were to be derived from a breathing-related interoceptive task.|Upto 2.5 hours|Decongestant and Test Nasal Strip Plus Decongestant groups were not included in this outcome measure as it was pre-specified to evaluate the effect on nasal strips on the measure of brain activity without the use of nasal decongestant.|||% signal change||Standard Deviation|Mean
2591134|NCT02275364|Primary|Anatomical Measures: Volume (Multiple Volume Reading)|Determination of averaged volume reading during the MRI (Average of 8 sub-regions)|Upto 2.5 hours|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 7 participants didn't meet the standards.|||mm^3||Standard Deviation|Mean
2591135|NCT02275364|Primary|Cerebral Blood Flow (CBF)|CBF was derived from Arterial-Spin Labelling (ASL) scans. ASL data were analysed using custom Matlab code, which fits a CBF model to the raw perfusion data, in order to derive quantitative estimates of CBF in units of ml/100g/minute. The computed CBF maps were co-registered to the subject's whole-brain T1-weighted anatomical scan (from the first scan session) in order to spatially divide the data into anatomical Regions of Interest (ROIs). The anatomical ROIs were themselves defined by nonlinear warping of a standard cytoarchitectonic atlas into the space of the subject's T1 anatomical scan, using the FMRIB Software Library tool FNIRT. CBF data were extracted for a subset of these anatomical ROIs.|Upto 2.5 hours|Decongestant and Test Nasal Strip Plus Decongestant groups were not evaluated in this outcome measure as it was pre-specified to to analyze effect of nasal strips on the cerebral blood without the use of nasal decongestant.|||ml/100g/min||Standard Deviation|Mean
2591136|NCT02275364|Primary|Anatomical Measure: Volume (Single Volume Reading)|Determination of single volume reading derived from examination of the nasal passages and sinuses, during the MRI.|Upto 2.5 hours|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 7 participants didn't meet the standards.|||mm^3||Standard Deviation|Mean
2591137|NCT02275364|Primary|Functional Brain Activity: Blood Oxygen Level Dependent- Interoceptive Attention Task|Regional measures of functional brain activity to be derived from a breathing-related interoceptive task. This outcome measure was pre-specified to analyze effect on nasal strips on the functional brain activity without the use of nasal decongestant.|Upto 2.5 hours|Decongestant and Test Nasal Strip Plus Decongestant groups were not included in this outcome measure as it was pre-specified to analyze effect on nasal strips on the brain activity without the use of nasal decongestant|||% Signal||Standard Deviation|Mean
2591138|NCT02275364|Primary|Anatomical Measures : Cross Sectional Area|Determination of cross sectional area derived from examination of the nasal passages and sinuses using T1 weighted MRI scans.|Upto 2.5 hours|Per-Protocol (PP) Population: Participants successfully completing all conditions of the experiment on single visit day except whose data didn't meet quality standards (problems with devices/software or participant (excessive head-motion during fMRI, inadequate performance of experimental tasks). Data of 7 participants didn't meet the standards.|||mm^2||Standard Deviation|Mean
2591139|NCT02275338|Secondary|Median Change From Baseline in Quality of Life as Assessed by ESAS in Phase 2|Quality of Life was assessed by both subject and investigator based on the ESAS. The ESAS scale evaluates 9 symptoms common in cancer subjects: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing and shortness of breath. The severity at the time of assessment of each symptom is rated from 0 to 10 on a numerical scale, 0 = symptom is absent and 10 = worst possible severity. Each symptom rating was interpreted independently and a total symptom distress score was calculated for both subject and investigator assessed scores as the sum of the 9 items. Median change from baseline (Day 0) in total symptom distress score, at each of the Phase 2 timepoints is presented and a positive change indicates a worsening condition.|Days 0, 35, 42 and 56|All subjects who received at least 1 dose of study medication (ITT population) and were continuing in Phase 2 of the study. Only subjects with data available for analysis at each timepoint are presented.|||units on a scale||Inter-Quartile Range|Median
2591140|NCT02275338|Secondary|Percentage of Responders Before or at Phase 2 Timepoints|This endpoint assessed the overall percentage of subjects continuing from Phase 1 and confirmed as a responder at the end of Phase 1, showing a continued response at Days 35, 42 and 56. A responder was defined as a subject experiencing ≤2 vomiting episodes/day during at least 3 consecutive days at any timepoint between Day 0 and Days 35, 42, 56 (for subjects without NGT at baseline), or as a subject in whom the NGT had been removed during at least 3 consecutive days at any timepoint between Day 0 and Days 35, 42, 56 without vomiting recurrence (for subjects with NGT at baseline), as recorded on diary cards which were completed every day.|From Day 0 to Day 56|All subjects who received at least 1 dose of study medication (ITT population) and were continuing in Phase 2 of the study.|||percentage of responders|||Number
2591141|NCT02275338|Secondary|Median Change From Baseline in Abdominal Pain Scores Assessed Using Visual Analogue Scale (VAS) in Phase 1|Abdominal pain was assessed using the VAS numeric pain distress scale. The VAS is a 100-millimetre (10-centimetre) scoring scale on which subjects marked on their perceived level of pain. Score range on VAS is from 0 to 100 where 0 = no pain and 100 = unbearable pain. Median change from baseline (Day 0) at each of the Phase 1 timepoints is presented and a positive change indicates a worsening condition.|Days 0, 7, 14 and 28|All subjects who received at least 1 dose of study medication (ITT population). Only subjects with data available for analysis at each timepoint are presented.|||units on a scale||Inter-Quartile Range|Median
2591142|NCT02275338|Secondary|Median Change From Baseline in Number of Daily Episodes of Nausea in Phase 1|"The mean number of daily episodes of nausea were calculated as the sum of episodes of nausea reported the last 3 days before the corresponding visit, divided by 3.~The median change from baseline (Day 0) at each of the Phase 1 timepoints is presented and positive change indicates a worsening condition."|Days 0, 7, 14 and 28|All subjects who received at least 1 dose of study medication (ITT population). Only subjects with data available for analysis at each timepoint are presented.|||Daily episodes of nausea||Inter-Quartile Range|Median
2591143|NCT02275338|Secondary|Median Change From Baseline in General Activity as Assessed by the Karnofsky Performance Status (KPS) Scale in Phase 1|The KPS scale was used to quantify subject's general well-being and activities of daily life. Subjects were classified based on their functional impairment and KPS scores range from 0 (death) to 100 (no evidence of disease). KPS scores are classified as 0-40 = unable to care for self; requires equivalent of institutional or hospital care; disease may be progressing rapidly; 50-70 = unable to work; able to live at home and care for most personal needs; varying amount of assistance needed; 80-100 = able to carry on normal activity and to work; no special care needed. Median change from baseline (Day 0) at each of the Phase 1 timepoints is presented and a negative change indicates a worsening condition.|Days 0, 7, 14 and 28|All subjects who received at least 1 dose of study medication (ITT population). Only subjects with data available for analysis at each timepoint are presented.|||units on a scale||Inter-Quartile Range|Median
2591460|NCT02271477|Secondary|Percentage of Participants Administered Vasoactive Drug|"Total amount of vasoactive drug administered for each group; for vasoactive drug we intended the use both of atropine than vascular amine"|30 minutes after spinal anesthesia||||percentage of participants|||Number
2591144|NCT02275338|Secondary|Median Change From Baseline in Quality of Life as Assessed by Edmonton Symptom Assessment System (ESAS) in Phase 1|Quality of Life was assessed by both subject and investigator based on the ESAS. The ESAS scale evaluates 9 symptoms common in cancer subjects: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing and shortness of breath. The severity at the time of assessment of each symptom is rated from 0 to 10 on a numerical scale; 0 = symptom is absent and 10 = worst possible severity. Each symptom rating was interpreted independently and a total symptom distress score was calculated for both subject and investigator assessed scores as the sum of the 9 items. Median change from baseline (Day 0) in total symptom distress score, at each of the Phase 1 timepoints is presented and a positive change indicates a worsening condition.|Days 0, 7, 14 and 28|All subjects who received at least 1 dose of study medication (ITT population). Only subjects with data available for analysis at each timepoint are presented.|||units on a scale||Inter-Quartile Range|Median
2591145|NCT02275338|Secondary|Median Time Between First Lanreotide Autogel® Injection and Clinical Response in Phase 1|The time for clinical response in Phase 1 (up to Day 28) was defined as the time from inclusion (Day 0) to the date of clinical response. A response was defined as occurrence of ≤ 2 vomiting episodes/day for at least 3 consecutive days at any timepoint between Day 0 and Day 28 (for patients without NGT use at baseline) or the removal of NGT for at least 3 consecutive days at any timepoint between Day 0 and Day 28 without vomiting recurrence (for patients with NGT use at baseline). The Kaplan-Meier estimate of median time to clinical response are presented.|From Day 0 to Day 28|All subjects who received at least 1 dose of study medication (ITT population).|||days||95% Confidence Interval|Median
2591146|NCT02275338|Secondary|Percentage of Responders in Phase 1|This endpoint assessed the overall percentage of responding subjects at the Phase 1 timepoints of Days 14 and 28. A responder was defined as a subject experiencing ≤ 2 vomiting episodes/day during at least 3 consecutive days at any timepoint between Day 0 and Days 14 or 28 (for subjects without NGT at baseline) or as a subject in whom the NGT has been removed, during at least 3 consecutive days without vomiting recurrence, at any timepoint between Day 0 and Days 14 and 28 (for subjects with NGT at baseline), as recorded on diary cards which were completed every day.|From Day 0 to Day 28|All subjects who received at least 1 dose of study medication (ITT population).|||percentage of responders|||Number
2591147|NCT02275338|Primary|Percentage of Responders Before or at Day 7|The primary endpoint assessed the percentage of responding subjects before or at Day 7. A responder was defined as a subject experiencing ≤2 vomiting episodes/day during at least 3 consecutive days at any timepoint between Day 0 and Day 7 (for subjects without NGT at baseline), or as a subject in whom the NGT had been removed during at least 3 consecutive days at any timepoint between Day 0 and Day 7 without vomiting recurrence (for subjects with NGT at baseline), as recorded on diary cards which were completed every day.|From Day 0 to Day 7|All subjects who received at least 1 dose of study medication (ITT population).|||percentage of responders|||Number
2591148|NCT02275156|Secondary|Mean Percent Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)|"Serum PCSK9 concentrations were determined using a qualified ELISA. The LLOQ of the assay was 15 ng/mL.~Log-transformed baseline PCSK9 was included in the model as a covariate and participant as a random effect."|Baseline and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose|Safety analysis set|||percent change||95% Confidence Interval|Geometric Mean
2591149|NCT02275156|Secondary|Area Under the Effect Curve From Baseline to Day 57 (AUECday1-57) for Low-density Lipoprotein Cholesterol (LDL-C)|The derived log-transformed AUECday1-57 for direct LDL-C was analyzed using a mixed-effect analysis of variance model. Log-transformed baseline LDL-C was the covariate.|4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose|Safety analysis set|||mg/dL*day||95% Confidence Interval|Geometric Mean
2591150|NCT02275156|Secondary|Number of Participants With Anti-evolocumab Antibodies|Blood samples were tested using an electrochemiluminescence-based bridging immunoassay to detect antibodies capable of binding to evolocumab.|57 days|Safety analysis set|||participants|||Number
2591151|NCT02275156|Secondary|Number of Participants With Clinically Relevant Vital Sign or Clinical Laboratory Changes|The investigator reviewed vital signs and laboratory test results and determined whether an abnormal value in an individual participant represented a clinically significant change from the participant's baseline values.|57 days|Safety analysis set|||participants|||Number
2591152|NCT02275156|Secondary|Number of Participants With Adverse Events|"The severity of each adverse event was graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:~fatal;~life threatening (places the participant at immediate risk of death);~requires in patient hospitalization or prolongation of existing hospitalization;~results in persistent or significant disability/incapacity;~congenital anomaly/birth defect;~other medically important serious event.~The investigator assessed whether each adverse event was possibly related to the study drug."|From the first dose of study drug up until Day 57|Safety analysis set (all participants who received at least 1 dose of study drug)|||participants|||Number
2591153|NCT02275156|Primary|Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last) for Evolocumab||Predose and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose|PK analysis set|||day*μg/mL||Standard Deviation|Mean
2591154|NCT02275156|Primary|Maximum Observed Serum Concentration (Cmax) of Evolocumab|Serum concentrations of evolocumab were measured by a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) of the assay was 800 ng/mL.|Predose and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose|Pharmacokinetic (PK) analysis set (all participants for whom at least 1 PK parameter could be adequately estimated)|||μg/mL||Standard Deviation|Mean
2591155|NCT02275117|Secondary|Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12|The SF-36 is a health survey containing 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks (range: 0=worst to 100=best). Increases from baseline indicate improvement.|Baseline to Week 12|Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.|||SF-36 Score||Standard Deviation|Mean
2591461|NCT02271477|Secondary|Total Amount of IV Fluid at the End of the Procedure|To assess if there is a difference between all treatments in the total quantity of fluids amount|30 minutes after spinal anesthesia||||milliliters (mL)||Inter-Quartile Range|Median
2591156|NCT02275117|Secondary|Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication|The percent of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.|Weeks 9-12|Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.|||percentage of acute medication headaches||Standard Deviation|Mean
2591157|NCT02275117|Secondary|Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication|The percent of migraines with acute medication usage. Participants with no migraines will be included with a rate of zero.|Weeks 9-12||||percentage of acute medication migraines||Standard Deviation|Mean
2591158|NCT02275117|Secondary|Change From Baseline in Monthly Headache Hours, Weeks 1-12|Headache hours are the sum of the duration of headaches within 4 week intervals, and the average 4 week duration within 12 week intervals.|Weeks 1-12|Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.|||Headache Hours||Standard Deviation|Mean
2591159|NCT02275117|Secondary|Change From Baseline in Monthly Migraine Hours, Weeks 1-12|Migraine hours are the sum of the duration of migraines within 4 week intervals, and the average 4 week duration within 12 week intervals.|Weeks 1-12|Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.|||Migraine Hours||Standard Deviation|Mean
2591160|NCT02275117|Secondary|Change From Baseline in Monthly Headache Episodes, Weeks 1-12|The number of monthly headache episodes as summarized over Weeks 1-12. A headache episode is defined as 1 continuously recorded headache. One episode may result in multiple headache days|Weeks 1-12|Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.|||Headache Episodes||Standard Deviation|Mean
2591161|NCT02275117|Secondary|Change From Baseline in Monthly Migraine Attacks, Weeks 1-12|The number of monthly migraine attacks summarized over Weeks 1-12. A migraine attack is defined as 1 continuously recorded migraine. One attack may result in multiple migraine days|Weeks 1-12|Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.|||Migraine Attacks||Standard Deviation|Mean
2591162|NCT02275117|Secondary|Time to First Migraine After Dosing|The median number of days after dosing a participant had the next migraine using the eDiary as the recall method|Baseline to Week 49 (End of Study)|Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.|||Days||95% Confidence Interval|Number
2591163|NCT02275117|Secondary|Percent Change From Baseline in Migraine Days|Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.|Weeks 1-12|Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.|||percentage of migraine days||Standard Deviation|Mean
2591164|NCT02275117|Secondary|Percent Change From Baseline in Headache Days|Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.|Weeks 1-12|Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.|||percentage of headache days||Standard Deviation|Mean
2591165|NCT02275117|Secondary|The Change From Baseline to Week 12 in HIT-6 Total Score|"The HIT-6 measures the impact of headache on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 12-week period. The total possible scores range from 36 (no impact) to 78 (worst impact). A score of 60 or above is labeled as severe."|Baseline to 12|Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.|||percentage of HIT-6 total score|||Number
2591166|NCT02275117|Secondary|Change From Baseline in Percentage of Severe Headaches|The change from baseline in percentage of headaches that are classified as severe over Weeks 9-12|Weeks 9-12|Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.|||percentage of severe headaches||Standard Deviation|Mean
2591167|NCT02275117|Secondary|Change From Baseline in Percentage of Severe Migraines|The change from baseline in percentage of migraines that are classified as severe over Weeks 1-12|Weeks 1-12|Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.|||percentage of severe migraines||Standard Deviation|Mean
2591168|NCT02275117|Secondary|The Change From Baseline in Monthly Migraine Days, Weeks 1-12|Monthly migraine days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.|Weeks 1-12|Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.|||days||Standard Deviation|Mean
2591169|NCT02275117|Secondary|The Change From Baseline in Monthly Headache Days, Weeks 1-12|Monthly headache days, as measured by eDiary. 4-weekly intervals averaged across weeks 1-12.|Weeks 1-12|Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.|||days||Standard Deviation|Mean
2591170|NCT02275117|Secondary|100% Migraine Responder Rate|Participants with an average reduction in migraine days of at least 100% over Weeks 1 to 12, as compared with baseline|Weeks 1-12|Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.|||Participants|||Count of Participants
2591171|NCT02275117|Secondary|100% Headache Responder Rate|Participants with an average reduction in headache days of at least 100% over Weeks 1 to 12, as compared with baseline|Weeks 1-12|Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.|||Participants|||Count of Participants
2605748|NCT02107014|Primary|Change in IL-17F From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2591172|NCT02275117|Secondary|50% Headache Responder Rate|Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline|Weeks 1-12|Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.|||Participants|||Count of Participants
2591173|NCT02275117|Secondary|50% Migraine Responder Rate|Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline|Weeks 1-12|Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.|||Participants|||Count of Participants
2591174|NCT02275117|Primary|75% Migraine Responder Rate|Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.|12 Weeks|Modified Full Analysis Population - Randomized participants who received investigational product or placebo, excluding participants from a site that was terminated by the Sponsor.|||Participants|||Count of Participants
2591175|NCT02275052|Secondary|Change From Baseline in Inspiratory Capacity (IC) 3 Hours Post-dose at Week 12 of Each Treatment Period|IC is defined as the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Standard body plethysmography techniques were used for lung volumes. Baseline is the IC value recorded pre-dose on Day 1 of each treatment period. Mean Baseline is the mean of the Baselines for each par. Period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each par. IC 3-hours post-dose was measured from the value obtained 3 hours after dosing on Day 2 and Week 12. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit (Day 2 or Week 12), smoking status, visit by period Baseline, visit by mean Baseline and visit by treatment interactions.|Baseline and at Week 12 of each treatment period (up to Week 30)|ITT Population including off-treatment data. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
2591176|NCT02275052|Secondary|Change From Baseline in Functional Residual Capacity (FRC) 3 Hours Post-dose at Week 12 of Each Treatment Period|FRC is defined as the amount of air still left in the lungs after breathing out normally. Standard body plethysmography techniques were used for lung volumes. Baseline is the assessment recorded before dosing on Day 1 of each period. Mean Baseline is the mean of the Baselines for each participant. Period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. FRC 3 hours post-dose was measured from the value obtained 3 hours after dosing on Day 2 and Week 12. Analysis was performed using a repeated measures model and the following covariates were included: period Baseline, mean Baseline, period, treatment, visit, smoking status, visit by period Baseline, visit by mean Baseline and visit by treatment interactions.|Baseline and at Week 12 of each treatment period (up to Week 30)|ITT Population including off-treatment data. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
2591177|NCT02275052|Secondary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 12 of Each Treatment Period|Trough FEV1 is a measure of lung function and is defined as the mean of FEV1 values obtained 23 and 24 hours after dosing on the previous day. Trough FEV1 measurements were taken electronically by spirometry on Day 2, Week 6 and Week 12. Baseline was the assessment recorded before dosing on Day 1 of each period. Mean Baseline is the mean of the Baselines for each participant. Period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Analysis was performed using a repeated measures model and the following covariates were included: period Baseline, mean Baseline, period, treatment, visit, smoking status, visit by period Baseline, visit by mean Baseline and visit by treatment interactions.|Baseline and at Week 12 of each treatment period (up to Week 30)|ITT Population including off-treatment data. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
2591178|NCT02275052|Primary|Change From Baseline in Exercise Endurance Time (EET) Post-dose at Week 12 of Each Treatment Period|EET post-dose at W12 is defined as the EET obtained 3 hours after dosing at W12. EET was measured using the externally paced field walking test called endurance shuttle walk test (ESWT). Change from BL in EET at W12 was analyzed using a repeated measures model with covariates of period walking speed, mean walking speed, period, trt, visit (Day 2, W6 and W12), smoking status, visit by period walking speed, visit by mean walking speed and visit by trt interactions. BL was the EET assessment obtained prior to dosing on Day 1 of each period. The mean walking speed for each par. is the mean of the levels used for the ESWT in each of the two trt periods. Period walking speed for each par. and trt period is the difference between the level for that par. and period and the mean walking speed for that par. Intent-to-treat (ITT) Population: all randomized par., excluding those who were randomized in error, and par. who discontinued trt (off-trt).|Baseline (BL) and at Week (W) 12 of each treatment (trt) period (up to Week 30)|ITT Population including off-treatment data. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Seconds (s)||Standard Error|Least Squares Mean
2591179|NCT02274948|Secondary|Change in Alanine Aminotransferase (ALT) Levels After One Year of Treatment With Matformin or Placebo|ALT was measured at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.|One year||||Iu/l||95% Confidence Interval|Mean
2591180|NCT02274948|Secondary|Change in Triglyceride Levels After One Year of Treatment With Matformin or Placebo|Triglyceride was measured at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.|One year||||mmol/l||95% Confidence Interval|Mean
2593564|NCT02244619|Post-Hoc|Hospital Length of Stay (LOS)|Total hospital length of stay was calculated as (hospital discharge moment - hospital admission moment). Hospital length of stay is reported in hours.|Pre-op admission to hospital discharge||||Hours||Inter-Quartile Range|Median
2591181|NCT02274948|Secondary|Change in Insulin Resistance Measured by HOMA-IR After One Year Treatment With Metformin or Placebo|"HOMA IR (Homeostatic model -Insulin Resistance) was calculated at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.~Homeostatic model (HOMA-IR = fasting blood sugar(mmol/l) × fasting insulin(mmol/l) ÷ 22.5)"|One year||||units on a scale||95% Confidence Interval|Mean
2591182|NCT02274948|Secondary|Change in Fasting Insulin After One Year of Treatment With Metformin or Placebo|Fasting insulin was calculated at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.|One year||||pmol/l||95% Confidence Interval|Mean
2591183|NCT02274948|Primary|Change in BMI and Percentage Fat Mass Standard Deviation Scores After One Year of Treatment With Metformin or Placebo|BMI and Percentage Fat Mass SDS was calculated at baseline and one year after giving Metformin or Placebo. The difference is calculated by subtracting the baseline value from one year value (value at 1 year - value at base line value). Data of the 150 that were followed up throughout the period was included.|One year||||Z score||95% Confidence Interval|Mean
2591184|NCT02274870|Secondary|Mean Plasma Bupivacaine Level||Baseline|Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw|||microgram per mL||Full Range|Mean
2591185|NCT02274870|Secondary|Mean Plasma Bupivacaine Level||2hrs|Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw|||microgram per mL||Standard Deviation|Mean
2591186|NCT02274870|Secondary|Mean Plasma Bupivacaine Level||4hrs|Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw|||microgram per mL||Standard Deviation|Mean
2591187|NCT02274870|Secondary|Mean Plasma Bupivacaine Level||12hrs|Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw|||microgram per mL||Standard Deviation|Mean
2591188|NCT02274870|Secondary|Mean Plasma Bupivacaine Level||24hrs|Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw|||microgram per mL||Standard Deviation|Mean
2591189|NCT02274870|Secondary|Mean Plasma Bupivacaine Levels||48hrs|Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw|||microgram per mL||Standard Deviation|Mean
2591190|NCT02274870|Secondary|Mean Plasma Bupivicaine Level||72hrs|Of the 32 and 33 participants in each arm 11 and 12 were allocated respectively to receive a blood draw|||microgram per mL||Standard Deviation|Mean
2591191|NCT02274870|Secondary|Opioid Consumption||24hrs||||Morphine milligram equivalents||95% Confidence Interval|Mean
2591192|NCT02274870|Secondary|Pain Intensity at Rest|"Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale.~Higher values represent a higher pain intensity or worse outcome."|24hrs||||VAS Scale||95% Confidence Interval|Mean
2591193|NCT02274870|Primary|Pain Intensity at Movement|"Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale.~Higher values represent a higher pain intensity or worse outcome."|24hrs||||VAS Scale||95% Confidence Interval|Mean
2591194|NCT02274857|Secondary|Evaluate the Acute Effectiveness of FIRM-guided Procedures in Eliminating the Source of Arrhythmia as Shown by: No Evidence of the Source in FIRMap Post-op, OR Reduction of Electrogram Amplitude to < 0.2 Millivolts||Immediately post procedure|ITT|||% of participants||95% Confidence Interval|Number
2591195|NCT02274857|Primary|Freedom From Procedure-related SAEs (Including Those Related to Any Repeat Procedures) Within 12-months of the Initial Procedure||3 to 12 months post study treatment|ITT group, defined as each subject randomized to a treatment group who had a mapping and/or ablation catheter inserted|||Participants|||Count of Participants
2591196|NCT02274857|Primary|Single-procedure Freedom From AF/AT Recurrence at 3 to 12 Months Post Index Procedure.||3-12 months post study treatment|ITT group, defined as each subject randomized to a treatment group who had a mapping and/or ablation catheter inserted|||% of participants|||Number
2591197|NCT02274857|Primary|Single-procedure Freedom From AF/AT Recurrence at 3 Month Post Index Procedure.||3-month follow up|ITT: each subject randomized to a treatment group who had a mapping and/or ablation catheter inserted Per Protocol: those subjects in the ITT group who completed all follow-up visits and had no major protocol deviations|||% of participants|||Number
2591198|NCT02274857|Primary|Freedom From Procedure-related Serious Adverse Events (SAEs) Within 7-10 Days of the Procedure||Within 7-10 days of the Procedure|Intent to Treat (ITT) group, defined as subject randomized to a treatment group who had a mapping and/or ablation catheter inserted|||% of participants|||Number
2591199|NCT02274792|Secondary|Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 12|Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept.|Week 12|Participants with a positive anti-etanercept antibody binding response at week 12|||percentage of participants||95% Confidence Interval|Number
2591200|NCT02274792|Secondary|Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 24|Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept.|Week 24|Participants with a positive anti-etanercept antibody binding response at week 24|||percentage of participants||95% Confidence Interval|Number
2591201|NCT02274792|Secondary|Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 12||Week 12|Participants with available antibody response data at week 12|||percentage of participants||95% Confidence Interval|Number
2591202|NCT02274792|Secondary|Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 24||Week 24|Participants with available antibody response data at week 24|||percentage of participants||95% Confidence Interval|Number
2591316|NCT02273180|Secondary|Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions|Percentage of participants with hypersensitivity reactions and injection site reactions were reported.|First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)|Analysis was performed on safety population.|||percentage of participants|||Number
2591203|NCT02274792|Primary|Percentage of Participants With Positive Anti-etanercept Binding Antibody Response During the Study|Seroreactivity to etanercept was evaluated using a validated enzyme-linked immunosorbent assay (ELISA).|Blood samples were collected for anti-etanercept antibody analysis before the administration of etanercept at baseline (day 1) and at week 12 and week 24.|Primary Antibody Analysis Set included all enrolled participants who received ≥ 1 dose of investigational product and had both a baseline and ≥ 1 post-baseline serum obtained for anti-etanercept antibody assessment, excluding participants with a negative antibody response at week 12 and missing antibody assessment at week 24.|||percentage of participants||95% Confidence Interval|Number
2591204|NCT02274766|Secondary|Change in the Standardized PD Home Diary (ON Time Without Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)|A PD home diary was used to score 5 different conditions in 30-minute intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. The results were based on 2 consecutive 24-hour diaries taken prior to the day of randomization and prior to the Week 2, 4, 8, and 12 visits.|Baseline to Week 12|MITT population|||hours||Standard Error|Least Squares Mean
2591205|NCT02274766|Primary|Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score|The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 4, 8, and 12.|Baseline to Week 12|MITT population|||units on a scale||Standard Error|Least Squares Mean
2591206|NCT02274688|Secondary|Drug Use Problems|The investigators used the Drug Abuse Screening Test (DAST-10) as a continuous outcome measure. DAST-10 scale scores range from 0 to 10, with higher scores representing a worse outcome. No subscales were used.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||units on a scale||Standard Deviation|Mean
2591207|NCT02274688|Secondary|Number of Participants With One or More Emergency Department Visits Over Time|The investigators used population level data on emergency department health service use for the intent-to-treat sample|The investigators assessed emergency department service use over the course of the study.||||Participants|||Count of Participants
2591208|NCT02274688|Secondary|Number of Patients Carrying a Weapon|The investigation used a single yes/no item to assess whether the patient was carrying a weapon.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||Participants|||Count of Participants
2591209|NCT02274688|Secondary|Number of Participants With Suicidal Ideation|The investigators used PHQ-9 item 9 to assess suicidal ideation. For the analysis, a score of > 0 on item 9 of PHQ-9 was considered a positive endorsement and a worse outcome.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||Participants|||Count of Participants
2591210|NCT02274688|Secondary|Functional Status|The investigators used the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome. No other subscales will be used.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||units on a scale||Standard Deviation|Mean
2591211|NCT02274688|Secondary|Alcohol Use Problems|The investigators used the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome. No sub scales were used.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||units on a scale||Standard Deviation|Mean
2591212|NCT02274688|Primary|Change in Depression Symptoms Over the Course of the Six Months After Injury|The investigators used the Patient Health Questionnaire (PHQ-9) as a continuous measure, with scores ranging from 1 to 27. Higher scores represent a worse outcome. No subscales were used.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||units on a scale||Standard Deviation|Mean
2591213|NCT02274688|Primary|Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury|The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure. The scoring of the scale ranges from a minumum of 17 to a maximum of 85, with higher scores indicating a worse outcome. No subscales were used.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||units on a scale||Standard Deviation|Mean
2591214|NCT02274688|Primary|Change in Post Traumatic Concerns Over the Course of the Six Months After Injury|The primary outcome is the endorsement of ≥1 severe posttraumatic concerns.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||Participants|||Count of Participants
2591215|NCT02274675|Secondary|Wrist's Active Range of Motion|"Introduction: Wrist's active range of motion (AROM) is a measurement to identify how far the person's joints range can move in by moving with their own effort.~Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition. The total normalized AROM for normal wrist flexion-extension is about 144 angular degree, a person who is able to achieve or over this range consider normal or in good condition in this study. The minimum angular degree is 0.~Procedure: The wrist's AROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle at forearm, subject will be guided to sit upright with shoulder abducted at 30-60' and elbow flexed at 90-120' supported by an adjustable arm rest with strap and the subject will move their wrist to maximum range in both direction. The moving range will be recorded by the robot and stored as report in its software."|Active range of motion of wrist at week 6|Stroke subjects in rehabilitation centre.|||Angular degree||Standard Deviation|Mean
2591216|NCT02274675|Secondary|Wrist's Passive Range of Motion|"Introduction: Wrist's passive range of motion (PROM) is a measurement to identify how far the person's joints range can move in flexion-extension directed by a person manually.~Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition. The total normalized PROM for normal wrist flexion-extension is about 164 angular degree, a person who is able to achieve or over this range consider normal or in good condition in this study. The minimum angular degree is 0.~Procedure: The wrist PROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle, subject will be guided to sit upright with shoulder abducted at 30-60' and elbow flexed at 90-120' supported by an adjustable arm rest with strap and the wrist will be moved manually by the therapist to access the passive range of motion. The moving range will be recorded by the robot and store as report in its software."|Passive range of motion of wrist at week 6|Stroke subjects in rehabilitation centre.|||Angular degree||Standard Deviation|Mean
2591335|NCT02273115|Secondary|Neonatal Outcome: Neonatal Weight||Assessed from birth through discharge, on average 2 days after birth||||grams||Standard Deviation|Mean
2591217|NCT02274675|Secondary|Forearm's Passive Range of Motion|"Introduction: Forearm's passive range of motion (PROM) is a measurement to identify how far the person's joints range can move in pronation-supination directed by a person manually.~Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition.The normalized forearm pronation-supination is about 169 angular degree, a person who is able to achieve or over this range is considered normal or in good condition in this study. The minimum angular degree is 0.~Procedure: The forearm PROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle at forearm, subject will be guided to sit upright with shoulder abducted at 30-60' and elbow flexed at 90-120' supported by an adjustable arm rest with strap and the forearm will be moved manually by the therapist to access the passive range of motion. The moving range will be recorded by the robot and stored as report in its software."|Passive range of motion of forearm at week 6|Stroke subjects in rehabilitation centre.|||Angular degree||Standard Deviation|Mean
2591218|NCT02274675|Secondary|Forearm's Active Range of Movement|"Introduction: Forearm's active range of motion (AROM) is a measurement to identify how far the person's joints range can move in pronation-supination by moving with their own effort.~Scores: The score is measured in terms of angular degree, where the higher the degree of motion the better the person condition. The normalized AROM for normal forearm pronation-supination is about 157 angular degree, a person who is able to achieve or over this range consider normal or in good condition in this study. The minimum angular degree will be 0.~Procedure: The forearm AROM will be measured by using the CR2-Haptic robot, where the subject will hold the handle at forearm, subject will be guided to sit upright with shoulder abducted at 30-60' and elbow flexed at 90-120' supported by an adjustable arm rest with strap and the subject will move their forearm to maximum range in both direction. The moving range will be recorded by the robot and stored as report in its software."|Active range of motion of forearm at week 6|Stroke subjects in rehabilitation centre.|||Angular degree||Standard Deviation|Mean
2591219|NCT02274675|Secondary|Spasticity Level of Wrist|"Introduction: The spasticity level of wrist is measured by using Modified Ashworth Scale. It measures resistance during passive soft-tissue stretching. This measure will only measure the wrist component, as forearm component is not included in this scale.~Scoring: The total or maximum scores for the subscale is 4 and the minimum is 0 score. Higher scores indicates the higher the tone, lower score indicates less tone. 0 score indicates normal tone and no increase in tone, while 4 scores indicate affected part rigid in flexion or extension. All the scores will be summed.~Procedure: The measuring procedure starts by holding the elbow as straight as possible at forearm pronated. Then, the patient's wrist is moved from maximum possible flexion to maximum possible extension. The test is performed up tp maximum of 3 times to avoid the influence of the effect of stretch."|Spasticity level of wrist at week 6|Stroke subjects in rehabilitation centre.|||Scores||Standard Deviation|Mean
2591220|NCT02274675|Secondary|Motor Function Assessment of Hand Movement|"Introduction: Motor function that are related to wrist and forearm are measured using the Motor Assessment Scale. The Motor Assessment Scale (MAS) is a performance-based scale that was developed as a means of assessing everyday motor function in patients with stroke. In MAS, task 1 and 3 in the hand movement sub-component assessment were accessed (MAS-Hand), as the two task is the most related component to the tested movement.~Score: The total or maximum scores is 2, and minimum scores is 0. In this scale, the higher the score indicates the better the condition of the subject. The score for a healthy person is 2.~Procedure: The procedure is done according to the standard guideline of this assessment scale."|Motor function of hand function at week 6|Stroke subjects in rehabilitation centre.|||Scores||Standard Deviation|Mean
2591221|NCT02274675|Primary|Motor Impairment of Wrist and Forearm|"Introduction: Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale that are related to wrist and forearm component. The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.~Scores: With the component of upper extremity (max 4 scores), wrist (max 10 scores), passive joint motion (max 8 scores) and joint pain (max 8 scores), the total or maximum scores is the sum of all the component which is 30 and the minimum is 0. The score for a normal person is 30 scores. The higher the score indicates the better the condition of the subject.~Procedure: The procedure is done according to the standard guideline of this assessment scale."|Motor impairment of wrist and forearm at week 6|Stroke subjects in rehabilitation centre.|||Scores||Standard Deviation|Mean
2591222|NCT02274649|Secondary|Rehospitalization - Percent of Patients (180 Days)|Percent of patients (cumulative) rehospitalized within 180 days post discharge from inpatient rehabilitation|180 days||||percentage of paients|||Number
2591223|NCT02274649|Secondary|Rehospitalization - Number of Days (Cumulative)|Rehospitalization days (cumulative) within 180 days post inpatient rehabilitation discharge|180 days||||days||Standard Deviation|Mean
2591224|NCT02274649|Secondary|Rehospitalization - Percent of Patients Rehospitalized (90 Days)|Percent of patients (cumulative) rehospitalized within 90 days post discharge from inpatient rehabilitation|90 days||||percentage of patients|||Number
2591225|NCT02274649|Secondary|Rehospitalization - Number of Days (Cumulative)|Rehospitalization days (cumulative) within 90 days post inpatient rehabilitation discharge|90 days||||days||Standard Deviation|Mean
2591226|NCT02274649|Primary|Rehospitalization - Percent of Patients Rehospitalized|Percent of patients rehospitalized at 30 days post discharge from inpatient rehabilitation|30 days||||percentage of patients|||Number
2591227|NCT02274649|Primary|Rehospitalization - Number of Days|Rehospitalization days (number) within 30 days post inpatient rehabilitation discharge|30 days||||days||Standard Deviation|Mean
2591252|NCT02273973|Secondary|Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in PIK3CA Wildtype (WT) Participants|ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
2591336|NCT02273115|Secondary|Neonatal Outcome: NICU (Neonatal Intensive Care Unit) Admission, 5 Minutes Apgar <7||Assessed from birth through discharge, on average 2 days after birth||||Participants|||Count of Participants
2591337|NCT02273115|Secondary|Obstetric Complications||Assessed during induction, labor, delivery, and postpartum. On average, this would be over a 3-7 day time period||||Participants|||Count of Participants
2591228|NCT02274649|Primary|Self-efficacy Scale. It Includes an Adapted Self-efficacy Scale From Chronic Disease Literature Focused on Confidence in Managing Self-care Needs Plus Project-specific Items for Assessment of Confidence Regarding Integration Into Community Life.|"The General Self-Efficacy scale (6 items) developed at Stanford University for persons with chronic health conditions was adapted for persons with spinal cord injury. Added to this scale were 5 similarly constructed project-specific self-efficacy items focused on community navigation and accessibility (major focus of peer support program).~Respondents (via telephone interview) provided a response to each of 11 items using a 10-point Likert scale ranging from 1 (not confident) to 10 (very confident). Item response scores were averaged for the total self-efficacy score. Total scores ranged from 11 to 110 (11 items with 10 response options). Higher scores indicate greater self-efficacy to manage injury conditions.~Growth Curve Analysis was used to determined significant changes over time in self-efficacy. Initial status coefficients depict where participants begin at the first time point (3 days post discharge) and growth rate coefficients show how participants change over time."|3 days post rehabilitation discharge through 180 days post discharge||||units on a scale||Standard Error|Mean
2591229|NCT02274558|Secondary|Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Responder Analysis at Week 6|Percentage of AIMS responders (subjects who had at least a 50 percent reduction in AIMS score from baseline)|Week 6|Intent to treat (ITT) analysis set (all subjects in the safety analysis set who have a baseline (Day -1) AIMS dyskinesia total score value and at least one post-randomization AIMS dyskinesia total score value reported during the placebo-controlled treatment period).|||Participants|||Count of Participants
2591230|NCT02274558|Secondary|Clinical Global Impression of Change - TD (CGI-TD) at Week 6|Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).|Week 6|Intent to treat (ITT) analysis set (all subjects in the safety analysis set who have a baseline (Day -1) AIMS dyskinesia total score value and at least one post-randomization AIMS dyskinesia total score value reported during the placebo-controlled treatment period).|||scores on a scale||Standard Error|Least Squares Mean
2591231|NCT02274558|Primary|Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6|Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.|Baseline and Week 6|Intent to treat (ITT) analysis set (all subjects in the safety analysis set who have a baseline (Day -1) AIMS dyskinesia total score value and at least one post-randomization AIMS dyskinesia total score value reported during the placebo-controlled treatment period).|||scores on a scale||Standard Error|Least Squares Mean
2591232|NCT02274493|Secondary|LD Muscle Flap Failure Through 6 Months Post-procedure|Flap failure is defined as irreversible arterial and venous thrombosis detected by implantable or surface doppler signal.|Participants were followed for up to a total of 6 months post-operatively|1 participant withdrew study consent prior to post-procedure follow up visits.|||Participants|||Count of Participants
2591233|NCT02274493|Secondary|Evaluation of Donor Site Complications Through 6 Months Post-procedure|The participants listed were evaluated for donor site complication.|Participants were followed for up to a total of 6 months post-operatively|1 participant withdrew study consent prior to post-procedure follow up visits.|||Participants|||Count of Participants
2591234|NCT02274493|Primary|Number of Participants With LD Muscle Flap Viability Following Robotic-Assisted Harvest Procedure||Participants were followed for up to a total of 6 months post-operatively||||Participants|||Count of Participants
2591235|NCT02274493|Primary|Number of Participants Assessed for Donor Site Complications and Muscle Flap Viability|Muscle flap viability was determined by measuring the blood flow into and out of the muscle flap with a hand held Doppler after muscle harvest was complete|Participants were followed for up to a total of 6 months post-operatively|All participants were assessed for the primary measure|||Participants|||Count of Participants
2591236|NCT02274311|Secondary|PSA Levels|The objective is to compare the change of PSA value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90).|Day 90||||ng/mL||Standard Deviation|Median
2591237|NCT02274311|Secondary|Testosterone Levels|The objective is to compare the change of testosterone value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90).|D90|10 acromegalic patients were assessed, the other 6 patients did not have testosterone levels assessed.|||ng/dL||Standard Deviation|Median
2591238|NCT02274311|Primary|IGF-1 Levels|The objective is to compare the change of IGF-1 value assessed in the beginning of the study (day 0), with the value obtained after three months of use of clomiphene citrate (day 90).|Day 90||||ng/mL||Standard Deviation|Mean
2591239|NCT02273973|Secondary|Percentage of Participants With Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline up to 22 weeks|The safety population includes all randomized participants who received at least one dose of taselisib or placebo.|||percentage of participants|||Number
2591240|NCT02273973|Secondary|Mean Score for Treatment of Cancer Quality of Life Questionnaire BR23 (QLQ-BR23)|EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores were averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL. Here, Post surgery= PS.|Weeks 1, 5, 9, 13, 16, 4-week Post-Surgery|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||score on a scale||Standard Deviation|Mean
2591338|NCT02273115|Secondary|Regional Analgesia|Regional analgesia used during Foley ripening|Assessed during the induction, labor and delivery period, on average occurring between 24-48 hours||||Participants|||Count of Participants
2591241|NCT02273973|Secondary|Mean Score for Health-Related Quality of Life Measured by the European Organization for Research C30 (EORTC QLQ-C30)|EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. The first 28 questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). The last 2 questions represented the participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement. Here, Post surgery= PS.|Weeks 1, 5, 9, 13, 16, 4-week Post-Surgery|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||score on a scale||Standard Deviation|Mean
2591242|NCT02273973|Secondary|Percent Change From Baseline to Surgery in Enhancing Tumor Volume as Measured by Breast MRI||From Baseline to Surgery (Weeks 17-18)|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percent change||95% Confidence Interval|Number
2591243|NCT02273973|Secondary|Preoperative Endocrine Prognostic Index (PEPI ) Score|To obtain the PEPI score, risk points for relapse-free survival (RFS) and breast cancer-specific survival (BCSS) are assigned depending on the hazard ratio (HR) from the multivariable analysis. The total PEPI score assigned to each participant is the sum of the risk points derived from the primary tumor (pT) stage, regional lymph nodes (pN) stage, Ki67 level, and estrogen receptor status of the surgical specimen. A HR in the range of 1 to 2 receives one risk point; a HR in the 2 to 2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each participant is the sum of all the risk points accumulated from the four factors in the model, ranges from 0 (best possible outcome) to 12 (worst possible outcome).|Week 16|Data were not collected for this outcome measure.||||||
2591244|NCT02273973|Secondary|Central Assessments of Changes in Ki67 Levels|Ki67 is a prognostic marker and is used to evaluate the proliferative activity of breast cancer.|From Baseline to Week 3 and Surgery (Weeks 17-18); and Week 3 to Surgery (Weeks 17-18)|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage||95% Confidence Interval|Number
2591245|NCT02273973|Secondary|Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA WT Participants|ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
2591246|NCT02273973|Secondary|Percentage of Participants With OR by Clinical Breast Exam (Palpation) Via mRECIST Version 1.1 in PIK3CA MT Participants|ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
2591247|NCT02273973|Secondary|Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA WT Participants|ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
2591248|NCT02273973|Secondary|Percentage of Participants With OR by Mammography Via mRECIST Version 1.1 in PIK3CA MT Participants|ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
2591249|NCT02273973|Secondary|Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA WT Participants|ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
2591250|NCT02273973|Secondary|Percentage of Participants With OR by Breast Ultrasound Via mRECIST Version 1.1 in PIK3CA MT Participants|ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
2591251|NCT02273973|Secondary|Percentage of Participants With Total pCR Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA WT Participants|Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition).|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
2591292|NCT02273310|Secondary|School Functioning-Absences|School Absences reported by caregivers, Caregivers reported absences categorically (0-7 days = 1, 7-14 days = 2, etc). Higher numbers indicate more absences.|6 months||||Weeks (1 week = 7 days)||Standard Deviation|Mean
2591339|NCT02273115|Secondary|Number of Vaginal Deliveries||Assessed after delivery, on average occurring between 24-48 hours||||Participants|||Count of Participants
2591253|NCT02273973|Primary|Percentage of Participants With Total pCR , Defined as Having pCR in Both Breast and Axilla, Using AJCC Staging System in PIK3CA MT Participants|Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition).|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
2591254|NCT02273973|Primary|Percentage of Participants With OR by Centrally Assessed Breast MRI Via mRECIST Version 1.1 in Phosphatidylinositol-4,5-Bisphosphate 3-Kinase, Catalytic Subunit Alpha (PIK3CA) Mutant (MT) Participants|ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
2591255|NCT02273973|Primary|Percentage of Participants With Total Pathologic Complete Response (Total pCR), Defined as Having pCR in Both Breast and Axilla, Using American Joint Committee on Cancer (AJCC) Staging System|Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes ( i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition).|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
2591256|NCT02273973|Primary|Percentage of Participants With Objective Response (OR) by Centrally Assessed Breast Magnetic Resonance Imaging (MRI) Via Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1|Objective response rate (ORR) was defined as proportion of participants achieving complete response (CR) or partial response (PR). As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From Baseline to 16 weeks|ITT population includes all randomized participants regardless of whether they received any study drug (taselisib or placebo).|||percentage of participants|||Number
2591257|NCT02273960|Secondary|AUC Accumulation Index (AI_AUC) of BMS-986004|AUC accumulation index (AI_AUC) = ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose of BMS-986004. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.|Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)|"Evaluable PK Population. Only participants with adequate PK profiles were included in the summary statistics; 0 participants analyzed indicates no data were available for that cohort for this Summary Statistic"|||Ratio||Standard Deviation|Mean
2591258|NCT02273960|Secondary|Total Body Clearance (CLT) of BMS-986004|Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.|Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)|Evaluable PK Population. The number of analyzed participants in each arm at specified time points represent the actual number of subjects evaluated after intra-participant dose escalation once the participant had completed the response phase of the study.|||L/H||Standard Deviation|Mean
2591259|NCT02273960|Secondary|Trough Observed Serum Concentration (Ctrough) of BMS-986004|Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. Ctrough = Trough observed serum concentration. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.|Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)|Evaluable PK Population. The number of analyzed participants in each arm at specified time points represent the actual number of subjects evaluated after intra-participant dose escalation once the participant had completed the response phase of the study.|||ng/mL||Standard Deviation|Mean
2591260|NCT02273960|Secondary|Area Under the Concentration-time Curve in One Dosing Interval [AUC(TAU)] of BMS-986004|Pharmacokinetics of BMS-986004 were derived from serum concentration versus time data. AUC(TAU) = Area under the concentration-time curve in one dosing interval. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.|Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)|Evaluable PK Population. The number of analyzed participants in each arm at specified time points represent the actual number of subjects evaluated after intra-participant dose escalation once the participant had completed the response phase of the study.|||h*ng/mL||Standard Deviation|Mean
2591261|NCT02273960|Secondary|Maximum Observed Serum Concentration (Cmax) of BMS-986004|Pharmacokinetic parameter (Cmax) of BMS-986004, derived from serum concentration versus time. who have adequate PK profiles. On study Day 57, non-responders in each treatment group other than the 1500 mg group were dose escalated to the starting dose of the next higher treatment group.|Day 1 (0 hour [h], 2h, 24h, 72h, 168h), Day 15 (0h), Day 29 (0h), Day 43 (0h, 168h), Day 57 (0h, 2h), Day 71 (0h, 2h, 24h, 96h, 168h), Day 85 (0h, 336h, 672h, 1008h, 1344h)|Evaluable PK population defined as participants with adequate PK profiles. The number of analyzed participants in each arm at specified time points represent the actual number of subjects evaluated after intra-participant dose escalation once the participant had completed the response phase of the study.|||ng/mL||Standard Deviation|Mean
2591262|NCT02273960|Secondary|Response Rate (RR) of BMS-986004: Short Term and Long Term|Overall Response Rate (ORR) was defined as the proportion of participants who achieved a complete response (CR) or response (R). CR was defined as platelet count ≥ 100,000/mm3 and absence of bleeding. R was defined as platelet count ≥ 30,000/mm3 and at least 2-fold increase from the baseline count and absence of bleeding.|Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)|All participants who had received at least 1 dose of study treatment|||Proportion of participants|||Number
2591263|NCT02273960|Primary|Number of Laboratory Abnormalities of Safety Biomarkers: d-Dimer and Thrombin Anti-Thrombin (TAT)|D-dimer and thrombin antithrombin (TAT) in plasma were quantified as measures of thromboembolism risk. D-dimer was evaluated by Enzyme linked immune sorbent assay (ELISA) method (D-dimer reference range 0-0.63 micrograms/milliliters fibrinogen equivalent units [mcg/ml FEU]). TAT reference range 0-4.1 ng/ml.|Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long Term)|All participants who had received at least 1 dose of study treatment|||Events|||Number
2591264|NCT02273960|Primary|Number of ECG Abnormalities|The primary objective to establish safety was measured by investigator identified Electrocardiogram Abnormalities for both Short term and Long term periods. ECG parameters included heart rate, PR interval, QRS interval, and QTcF interval (QT interval corrected for heart rate)|Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)|All participants who had received at least 1 dose of study treatment|||Events|||Number
2591265|NCT02273960|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Short Term and Long Term|The primary objective to establish safety was measured by the primary endpoints of AEs and SAEs for both Short term and Long term periods|Day 1 to Day 141 (Short term) and Day 1 to Day 398 (Long term)|All participants who had received at least 1 dose of study treatment|||Participants|||Count of Participants
2591266|NCT02273908|Other Pre-specified|Number of Patients With Adverse Events||Visit2(week4),Final Visit(Week8 or discontinuation)|Safety Analysis Set; All subjects who received at least one dose of pregabalin. The primary objectives of this study did not include comparison of safety with usual care, consistent with the non-interventional nature of the study. Therefore, adverse events were not collected from the participants in usual care.|||participants of related AEs|||Number
2591267|NCT02273908|Secondary|Work Productivity and Activity Impairment Scale (WPAI:LBP)|"The WPAI: LBP is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, n signifies Number of participants for Baseline.~In this study, the WPAI: LBP will measure the effect of the patient's Chronic Low Back Pain (CLBP) with accompanying lower limb pain (neuropathic component) on work productivity and regular activities."|Final Visit (Week8 or discontinuation)|Full Analysis Set|||percentage of time missed||Standard Deviation|Mean
2591268|NCT02273908|Secondary|Patient Global Improvement of Change (PGIC)|The PGIC is a subject-rated instrument that measures change in the subject's overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).|Final Visit (Week8 or discontinuation)|Full Analysis Set|||participants|||Number
2591269|NCT02273908|Secondary|Clinical Global Impression of Change (CGIC)|The CGIC assessment includes one question (1-7 scale) inquiring about the subject's improvement considering their current disease state.; range from 1 (very much improved) to 7 (very much worse).|Final Visit (Week8 or discontinuation)|Full Analysis Set|||participants|||Number
2591270|NCT02273908|Secondary|Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale -|"The EQ-5D-5L is a copyrighted, subject-completed questionnaire designed to assess health-related quality of life in terms of a single index value or utility score. There are two components to the EQ-5D-5L: A Health State Profile and a Visual Analogue Scale (VAS). Recent guidance suggests that the Health State Profile and VAS should be administered together.~The Visual Analogue Scale (VAS) is designed to rate the subject's current health state on a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state."|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set|||units on a scale||Standard Error|Least Squares Mean
2591271|NCT02273908|Secondary|Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score-|"The EQ-5D-5L is a copyrighted, subject-completed questionnaire designed to assess health-related quality of life in terms of a single index value or utility score. The Health State Profile is designed to record the subject's level of current health for five domains comprising a health profile: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Responses from the five domains are used to calculate a single utility index value.; 1 indicates better health state (no problems); 5 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile; from 11111 to 55555. Score is transformed and results in a total score range -0.025 to 1.000; higher score indicates a better health state."|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set|||units on a scale||Standard Error|Least Squares Mean
2591272|NCT02273908|Secondary|Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall)|The Pain NRS (past week recall) consists of an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Subjects are asked to describe their average pain during the past week by choosing the appropriate number between 0 and 10.|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set|||scores on a scale||Standard Error|Least Squares Mean
2591273|NCT02273908|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score-|The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function.|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set|||scores on a scale||Standard Error|Least Squares Mean
2591274|NCT02273908|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score-|The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function.|Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)|Full Analysis Set|||scores on a scale||Standard Error|Least Squares Mean
2591293|NCT02273310|Primary|Child-Reported Health Related Quality of Life-School Functioning Subscale|Assessed using the Pediatric Quality of Life Inventory, Scores range from 0-100 with higher scores indicating better quality of life.|6 months||||units on a scale||Standard Deviation|Mean
2591340|NCT02273115|Secondary|Time to Foley Expulsion||0-12 hours||||hours||Inter-Quartile Range|Median
2591341|NCT02273115|Secondary|Total Time to Delivery||On average, 24-36 hours||||hours||Inter-Quartile Range|Median
2591275|NCT02273908|Primary|Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall)|The Pain Related Sleep Interference Scale (past week recall) consists of an 11-point rating scale ranging from 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change the rating scale from baseline to week 8 in each group. Subjects are to describe how their pain has interfered with their sleep during the past week by choosing the appropriate number between 0 and 10.|Baseline, Final Visit (Week 8)|Full Analysis Set; consisted of subjects who had at least one evaluable observation from any of the patient-reported outcomes, and only evaluable subjects who contributed to the particular outcome were evaluated in each analysis. 'n' signifies number of participants who were evaluable for specified categories at different time points|||scores on a scale||Standard Error|Least Squares Mean
2591276|NCT02273752|Secondary|Response Rate Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Response rate will be measured at different time points, e.g. 8, 16, and 24 weeks, and will be summarized as percentage of stable disease, complete remission or partial remission along with 95% confidence interval.|Up to 24 weeks|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.||||||
2591277|NCT02273752|Secondary|Type of Treatments for Stomatitis|Type of treatments for stomatitis will be collection of prescription and non-prescription interventions.|Up to 6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.||||||
2591278|NCT02273752|Secondary|Frequency of Treatments for Stomatitis|Frequency of treatments for stomatitis will be collection of prescription and non-prescription interventions.|Up to 6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.||||||
2591279|NCT02273752|Secondary|Dose Interruptions and Adjustments|Dose interruptions and adjustments will be made on a per subject basis and total for the population.|Up to 6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.||||||
2591280|NCT02273752|Secondary|Percentage of Days on Therapy|Percentage of days on therapy will be calculated using the formula: (expected - actual days)/expected x 100.|Up to 6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.||||||
2591281|NCT02273752|Secondary|Downstream Markers of Mammalian Target of Rapamycin (mTOR) Function Measured in Peripheral Blood Mononuclear Cells|Pharmacodynamics will be evaluated for phosphorylated and non-phosphorylated ribosomal protein S6 kinase, protein kinase B, and eukaryotic translation initiation factor 4E-binding protein 1.|Up to day 15 of course 1|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.||||||
2591282|NCT02273752|Secondary|Progression Free Survival (PFS)|PFS will be evaluated based on rates of cancer progression and time to progression in the population. Progression will be determined using standard RECIST criteria. The median PFS for this study will be estimated by Kaplan-Meier method along with 95% confidence interval.|6 months|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.||||||
2591283|NCT02273752|Primary|Incidence of Stomatitis|Stomatitis graded rates and severity will be evaluated and recorded per World Health Organization and Common Terminology Criteria for Adverse Events criteria in the study population.|Day 29|Trial was closed early due to lack of timely accrual. Because study was not fully enrolled, outcomes were unable to be measured accurately.||||||
2591284|NCT02273323|Secondary|Diastolic Blood Pressure Sitting|Diastolic blood pressure measured while sitting|Before and 90 minutes after test product intake|All participants who received at least one dose of each intervention and completed all study visits|||mmHg||Standard Deviation|Least Squares Mean
2591285|NCT02273323|Secondary|Systolic Blood Pressure Sitting|Systolic blood pressure measured while sitting|Before and 90 minutes after test product intake|All participants who received at least one dose of each intervention and completed all study visits|||mmHg||Standard Deviation|Least Squares Mean
2591286|NCT02273323|Secondary|Diastolic Blood Pressure Supine|Diastolic blood pressure measured while lying down|Before and 110 minutes after test product intake|All participants who received at least one dose of each intervention and completed all study visits|||mmHg||Standard Deviation|Least Squares Mean
2591287|NCT02273323|Secondary|Systolic Blood Pressure Supine|Systolic blood pressure measured while lying down|Before and 110 minutes after test product intake|All participants who received at least one dose of each intervention and completed all study visits|||mmHg||Standard Deviation|Least Squares Mean
2591288|NCT02273323|Secondary|Endothelium-independent Vasodilation|Endothelium-independent dilation after glyceryl trinitrate defined as maximal percent increase in diameter|2.5 hours after test product intake|All participants who received at least one dose of each intervention and completed all study visits|||percentage of change in diameter||95% Confidence Interval|Least Squares Mean
2591289|NCT02273323|Primary|Flow Mediated Dilation|"Flow mediated dilation (FMD) of the brachial artery was measured using vascular ultra sound and automated edge detection software:~1 minute baseline scan to measure the baseline diameter of artery~5 minutes of forearm occlusion at 250±30 mmHg, below the elbow (2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion Percentage FMD was calculated as the maximum increase in diameter after cuff release relative to the baseline diameter"|Before and 2 hours after test product intake|All participants who received at least one dose of each intervention and completed all study visits|||percentage of change in diameter||Standard Deviation|Least Squares Mean
2591290|NCT02273310|Secondary|Acceptability of Intervention|Families in the FTC group rated acceptability of participating in the intervention workshop. This measure was completed at the workshop (between baseline and 6 month assessments). This measure utilized a 5-point Likert-type scale (with the possible range of scores as 1-5), with higher scores indicating more positive feedback. Individual item scores are presented here. Participant results indicated a range of scores from from 2-5.|post intervention||||units on a scale||Standard Deviation|Mean
2591291|NCT02273310|Secondary|Number of Accommodations Provided to Families by Schools|Number of Accommodations Provided to Families by Schools As reported by caregivers|6 months||||Number of Accommodations||Standard Deviation|Mean
2591294|NCT02273206|Secondary|Self-efficacy and Behavior Towards Cancer Screening/Mental Health Utilization|"This 5-item scale measures a sense of perceived self-efficacy associated with accessing and paying for the three different types of cancer screening and utilization of needed mental health services.~The continuous study score was converted into 4 categories using quartiles as cut points. The 4 categories are high self-efficacy, moderate self- efficacy, minimal self-efficacy and low self-efficacy."|Baseline, 6 months and 12 months|Data are collected at baseline, 6 months and 12 months. Not all participants completed the assessment at all time points.|||Participants|||Count of Participants
2591295|NCT02273206|Secondary|Medication Adherence|"In this questionnaire, respondents were asked if they had been prescribed medication for depression and about difficulties taking medication(s) regularly.~Standard cut points was used for medical adherence. High adherence- around an 8. Medium adherence - 6-7.99. Low adherence would be anything less than 6."|Baseline, 6 months and 12 months|This data is collected at baseline, 6 months and 12 months. Not all participants completed the assessment at all time points|||Participants|||Count of Participants
2591296|NCT02273206|Secondary|Ambulatory Care Experiences as Assessed by Ambulatory Care Experiences Survey|"The Ambulatory Care Experiences Survey produces 11 summary measures covering 2 broad dimensions of patients' experiences: quality of physician-patient interactions and organizational features of care.~The continuous summary score was converted into 4 categories (High, Moderate, Fair and Low) using quartiles as cut-points."|Baseline, 6 months and 12 months|This data is collected at baseline, 6 months and 12 months. Not all participants completed this instrument at all time points.|||Participants|||Count of Participants
2591297|NCT02273206|Secondary|Devaluation-Discrimination Scale|This measure was adapted from the Link's Devaluation-Discrimination Scale.The continuous summary score was converted into 4 categories using quartiles as cut points. The 4 categories were as follows: Low stigma, minimal stigma, moderate stigma and high stigma.|Baseline and 12 months|This data is collected at baseline and 12 months. Not all participants completed this instrument at all time points.|||Participants|||Count of Participants
2591298|NCT02273206|Secondary|Satisfaction With Decision Scale- Mental Health (Data Reported in Secondary Outcome Measure #10)|The Satisfaction with Decision Scale is a 6-item measure that uses a five-point Likert-type scale; it is grounded in a conceptual model of an effective decision, i.e., one that is informed, consistent with the decision-maker's values, and behaviorally implemented. This scale has been tailored to healthcare decisions to have mental health care.The satisfaction with decision scale of mental health and its continuous summary score was converted into two categories (high satisfaction and low satisfaction) using the median as the cutoff point.|12 months||||Participants|||Count of Participants
2591299|NCT02273206|Secondary|Satisfaction With Decision Scale- Cancer Screening (Data Reported in Outcome Measure #10)|The Satisfaction with Decision Scale is a 6-item measure that uses a five-point Likert-type scale; it is grounded in a conceptual model of an effective decision, i.e., one that is informed, consistent with the decision-maker's values, and behaviorally implemented. This scale has been tailored to healthcare decisions to have cervical, breast, and colon cancer screening.The satisfaction with decision scale of cancer screening and its continuous summary score was converted into two categories (high satisfaction and low satisfaction) using the median as the cutoff point.|Baseline, 6 months and 12 months|This data is collected at baseline, 6 months and 12 months. Not all participants completed the assessment at all time points.|||Participants|||Count of Participants
2591300|NCT02273206|Secondary|Breast, Cervical and Colorectal Cancer Screening Attitudes|"This measure was adapted from the National Cancer Institute's HINTS questions for colorectal cancer.~The continuous summary score was converted into 4 categories using quartiles as cut points. The categories for screening attitudes were as follows: positive attitudes, moderate attitudes, fair attitudes and negative attitudes."|Baseline, 6 months and 12 months|This data is collected at baseline, 6 months and 12 months. Not all participants completed the assessment at all time points.|||Participants|||Count of Participants
2591301|NCT02273206|Secondary|Medical Outcomes Study Health Survey-Short Form|"The quality of life was measured with the Medical Outcomes Study (MOS) Short Form Health Survey (SF-12) is a general measure of health status that assess the patient's perceived health status and whether health problems interfere with normal functioning. The SF-12 has demonstrated validity and test-retest reliability in the general population and in patients with chronic health conditions, and has been tested in five languages, including Spanish. It has been used extensively as a quality of life measure in collaborative care studies, including with low-income minority populations. It has also been used frequently in screening studies, for cancer and other conditions. The SF-12 has been validated as an indicator of effects of depression on quality of life in ethnically diverse patients.~The continuous summary score was converted into 4 categories using quartiles as cutoff points. The four categories are Best Health, Good health, Fair Health and Worst Health."|Baseline, 6 months and 12 months|This data is collected at baseline, 6 months and 12 months. Not all participants completed the assessment at all time points.|||Participants|||Count of Participants
2591302|NCT02273206|Secondary|Generalized Anxiety Disorder|This Generalized Anxiety Disorder scale is based on diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) and measures probable anxiety disorder and severity of anxiety symptoms. Patients are asked to rate how often they have been bothered by 7 problems in the last 2 weeks on a 4-point scale. Standard cut points were used for the Generalized Anxiety Disorder measure. Minimal anxiety is (0-4). Mild Anxiety would be count as (5-9). Moderate Anxiety (10-14) and severe anxiety would be (15-21).|Baseline, 6 months and 12 months|This data is collected at baseline, 6 months and 12 months. Not all participants completed the assessment at all time points.|||Participants|||Count of Participants
2591303|NCT02273206|Secondary|Physician Recommendation of Screening/Mental Health Care|"This questionnaire, adopted from National Cancer Institute's (NCI) Health Information National Trends Survey (HINTS), assesses whether patients report that their primary care physician 1) has recommended cervical, breast, and colon cancer screening and 2) has recommended that the patient make an appointment with a mental health provider and/or take psychotropic medication. Two categories were created according to whether the patient received a physician recommendation (yes/no). The category of Recommendation for when they received a recommendation and a category of No Recommendation if they did not receive a recommendation"|Baseline, 6 months and 12 months|Data are collected at baseline, 6 months and 12 months. Not all participants completed the assessment at all time points.|||Participants|||Count of Participants
2591304|NCT02273206|Secondary|Satisfaction With Decision to Participate in Screening and Mental Health Care as Assessed by Decision Scale|The Satisfaction with Decision Scale is a 6-item measure that uses a five-point Likert-type scale; it is grounded in a conceptual model of an effective decision, i.e., one that is informed, consistent with the decision-maker's values, and behaviorally implemented. This scale has been tailored to healthcare decisions to receive treatment for emotional or mental health and to have cervical, breast, and colon cancer screening.The continuous summary score was converted into two categories using the median as a cut point. The two categories are high satisfaction and low satisfaction.|Baseline, 6 months and 12 months|This data is collected at baseline, 6 months and 12 months for 3 different instruments. Not all participants completed all instruments at all time points.|||Participants|||Count of Participants
2591305|NCT02273206|Secondary|Mental Health Care Utilization: Assessed by Patient Report|Participants were asked how many times in the past six months they had seen a provider to talk about or to receive medication for feeling sad, nervous, hopeless, or blue. This question was adapted from the NCI's HINTS survey. Two categories were created using the median as a cut point. The two categories were high utilization and low utilization.|Baseline, 6 months and 12 months|This data is collected at baseline, 6 months and 12 months for 3 different instruments. Not all participants completed all instruments at all time points.|||Participants|||Count of Participants
2591306|NCT02273206|Primary|Changes From Baseline in Number of Participants With Colorectal, Breast, and/or Cervical Cancer Screening|Self-Report: We will ask participants about their participation (yes/no) in specific screening methods: Pap testing (past 3 years), mammography (past 2 years), and colorectal screening (fecal occult blood tests (FOBT)/fecal immunohistochemical tests (FIT)), past year; flexible sigmoidoscopy, the past 5 years; and colonoscopy, past 10 years).|Baseline - 12 months|This data is collected at baseline and 12 months. Not all participants completed all instruments at all time points.|||Percentage (%) of Participants|||Number
2591307|NCT02273206|Primary|Change From Baseline in The Hopkins Symptom Checklist (SCL-20) at 12 Months|The SCL-20 consists of the 20 depression items on a 4-point scale from the SCL-90, and has been shown to be a valid and reliable measure of depression in diverse outpatient and community populations.|Baseline - 12 months|This data is collected at baseline and 12 months. Not all participants completed all instruments at all time points.|||Participants|||Count of Participants
2591308|NCT02273206|Primary|Change From Baseline in The Hopkins Symptom Checklist (SCL-20) at 6 Months|The SCL-20 consists of the 20 depression items on a 4-point scale from the SCL-90, and has been shown to be a valid and reliable measure of depression in diverse outpatient and community populations.|Baseline - 6 months|This data is collected at baseline and 6 months. Not all participants completed all instruments at all time points.|||Participants|||Count of Participants
2591309|NCT02273206|Primary|Comparison of Change in Patient Health Questionnaire-9 (PHQ9) Score by Intervention Arm|"Comparison of change in depression between the CCI and PCM arm before and after intervention. (Self-Report).~The Patient Health Questionnaire-9 (PHQ9) is a well-validated measure of Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) criteria for screening and diagnosing depressive episode, assessing severity, and monitoring treatment response. The PHQ9 score ranges from the minimum of 0 (no depression) to the maximum of 27 (severe depression). The detailed PHQ9 scores and corresponding level of depression severity are as follow: 0 (no depression), 1-4 (mild depression), 5-9 (medium-mild depression), 10-14 (moderate depression), 15-19 (moderately severe depression) and 20-27 (severe depression).~The mean change in PHQ9 score is the mean of the differences between PHQ9 score at baseline and the PHQ9 score at follow up for all cases in the respective intervention arm; the greater the change in PHQ9 score, the greater the improvement in depression severity."|Baseline - 12 months|These data are collected at baseline and 12 months. Not all participants completed all instruments at both time points.|||units on a scale||Standard Deviation|Mean
2591310|NCT02273206|Primary|Assessment of Cervical Cancer Screening Up to Date Status After Intervention|Multivariate logistic regression model was used to assess which factors contributed to cervical cancer screening up to date status|Baseline - 12 months||||Percentage of participants|||Number
2591311|NCT02273206|Primary|Assessment of Breast Cancer Screening Up to Date Status After Intervention|Multivariate logistic regression model was used to assess which factors contributed to breast cancer screening up to date status|Baseline - 12 months||||Percentage of Participants|||Number
2591312|NCT02273206|Primary|Assessment of Colorectal Cancer Screening Up to Date Status After Intervention|Multivariate logistic regression model was used to assess which factors contributed to colorectal cancer screening up to date status.|Baseline - 12 months||||percentage of participants|||Number
2591313|NCT02273206|Primary|Assessment of Colorectal, Breast, and Cervical Cancer Screening Up to Date Status|Comparison of the proportion of patients who were up to date for colorectal cancer, breast cancer and cervical cancer screenings before and after the intervention. (Chart Review)|Baseline - 12 months||||Percentage (%) of Participants|||Number
2591314|NCT02273180|Other Pre-specified|Change in Daily Insulin Dose From Baseline to Week 26 and Week 52|Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Week 26 and Week 52 values respectively.|Baseline, Week 26, Week 52|Analysis was performed on safety population. Here, number analyzed in each row = participants with available data for specified categories.|||U/kg||Standard Deviation|Mean
2591315|NCT02273180|Secondary|Percentage of Participants With Treatment Emergent Anti-insulin Antibodies (AIAs)|Participants with treatment-emergent AIA (incidence) were reported (as participants with treatment-boosted or treatment-induced AIAs). Participants with treatment-induced AIAs were those who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample). Participants with treatment-boosted AIAs were those with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period, in those participants with pre-existing AIA).|First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)|Analysis was performed on anti-insulin antibody population that included all participants randomized and exposed to at least 1 dose of IMP (SAR342434 or Humalog) with at least one AIA sample available for analysis during the 12-month on-treatment period.|||percentage of participants|||Number
2591317|NCT02273180|Secondary|Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year|Number of treatment-emergent hypoglycemia events per participant-year of exposure were reported. Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (3.9 mmol/L). Hypoglycemic episodes with plasma glucose of 54 mg/dL (<3.0 mmol/L) were also analyzed.|First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)|Analysis was performed on safety population that included all participants randomized and exposed to at least 1 dose of investigational medicinal product (IMP) (SAR342434 or Humalog), regardless of the amount of treatment administered.|||events per participant-year|||Number
2591318|NCT02273180|Secondary|Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26|Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour PPG minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as average across the profiles performed in the week before the visit. Change in PPG excursions was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the main 6-month period and adequate contrasts at Week 26.|Baseline, Week 26|Analysis was performed on ITT population. Here, number analyzed in each row = participants with at least one post-baseline data during the main 6-month period for specified categories.|||mmol/L||Standard Error|Least Squares Mean
2591319|NCT02273180|Secondary|Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26|Mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in week before a visit. Change in mean 24-hour plasma glucose concentration was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the main 6-month period and adequate contrasts at Week 26.|Baseline, Week 26|Analysis was performed on ITT population. Here, number of participants analyzed = participants with at least one post-baseline mean 24-hour plasma glucose concentration assessment during the main 6-month period.|||mmol/L||Standard Error|Least Squares Mean
2591320|NCT02273180|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM approach to account for missing data, using all post-baseline FPG data available during the main 6-month period and adequate contrasts at Week 26.|Baseline, Week 26|Analysis was performed on ITT population. Here, number of participants analyzed = participants with at least one post-baseline FPG assessment during the main 6-month period.|||mmol/L||Standard Error|Least Squares Mean
2591321|NCT02273180|Secondary|Percentage of Participants With HbA1c <7.0% at Week 26|Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.|Week 26|Analysis was performed on ITT population.|||percentage of participants|||Number
2591322|NCT02273180|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the main 6-month period and adequate contrasts at Week 26.|Baseline, Week 26|Analysis was performed on intent-to-treat (ITT) population that included all randomized participants, irrespective of compliance with the study protocol and procedures. Here, number of participants analyzed = participants with at least one post-baseline HbA1c assessment during the main 6-month period.|||percentage of HbA1c||Standard Error|Least Squares Mean
2591323|NCT02273167|Secondary|Polyp Detection Rate (Overall Colon)|Comparison of the number of patients with at least one polyp detected in the overall colon when NER1006 is used for bowel cleansing versus number detected when MOVIPREP is used. PDR defined as the number of patients with at least one polyp in the overall colon.|Up to 2 days (from day of first dosing to day of colonoscopy)|The overall number of participants analysed is based on the mFAS. This included all randomized patients except those patients who (i) were randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug (n=822).|||Participants|||Number
2591324|NCT02273167|Secondary|Polyp Detection Rate (Colon Ascendens)|Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 2-Day and 1-Day is used for bowel cleansing versus MOVIPREP. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.|Up to 2 days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug|||Participants|||Count of Participants
2591325|NCT02273167|Secondary|Adenoma Detection Rate (Overall Colon)|Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 2-Day and 1-Day is used for bowel cleansing versus MOVIPREP. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the overall colon.|Up to 2 days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
2591342|NCT02273115|Secondary|Number of Participants With Time to Delivery Achieved Within 12 Hours|Number of participants with a time from Foley placement to delivery less than or equal to 12 hours|Within 12 hours||||Participants|||Count of Participants
2591343|NCT02273115|Primary|Delivery Rate|The rate of women who deliver in less than or equal to 24 hours from Foley placement.|Within 24 hours||||Participants|||Count of Participants
2591326|NCT02273167|Secondary|Adenoma Detection Rate (Colon Ascendens)|Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 2-Day and 1-Day is used for bowel cleansing versus MOVIPREP. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.|Up to 2 days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
2591327|NCT02273167|Primary|Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)|The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). Highly effective cleansing in the colon ascendens corresponded to scores 3 (Good) or 4 (Excellent) of the HCS. Adequate plus failure of cleansing corresponded to score 0-2. Comparison of 'Excellent plus good' cleansing of the colon ascendens using NER1006 2-Day and 1-Day versus MOVIPREP was evaluated using a non-inferiority study design.|Up to 2 days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
2591328|NCT02273167|Primary|Number of Patients With Successful Bowel Cleansing (Overall Colon)|The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e. all mucosa could be visualized) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 2-Day and 1-Day versus MOVIPREP was evaluated using a non-inferiority study design.|Up to 2 days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
2591329|NCT02273141|Secondary|Polyp Detection Rate (Overall Colon)|Comparison of the number of patients with at least one polyp detected in the overall colon when NER1006 is used for bowel cleansing versus SP+MS. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the overall colon.|One day (day before colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
2591330|NCT02273141|Secondary|Polyp Detection Rate (Colon Ascendens)|Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 is used for bowel cleansing versus SP+MS. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.|One day (day before colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
2591331|NCT02273141|Secondary|Adenoma Detection Rate (Overall Colon)|Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 is used for bowel cleansing versus SP+MS. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the overall colon.|One day (day before colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients with the exception of any patient who was randomized but subsequently failed to meet entry criteria and in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug (n=501).|||Participants|||Count of Participants
2591332|NCT02273141|Secondary|Adenoma Detection Rate (Colon Ascendens)|Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 is used for bowel cleansing versus SP+MS. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.|One day (day before colonoscopy).|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
2591333|NCT02273141|Primary|Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)|The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). Highly effective cleansing in the colon ascendens corresponded to scores 3 (Good) or 4 (Excellent) of the HCS. Adequate plus failure of cleansing corresponded to score 0-2. Comparison of 'Excellent plus good' cleansing of the colon ascendens using NER1006 versus SP+MS was evaluated using a non-inferiority study design.|One day (day before colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
2591334|NCT02273141|Primary|Number of Patients With Successful Bowel Cleansing (Overall Colon)|The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e. all mucosa could be visualized) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 versus SP+MS was evaluated using a non-inferiority study design.|One day (day before colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
2591344|NCT02273063|Primary|Total Score on Inventory of Depressive Symptomatology, Self-Report (IDS-SR) Scale|"This self-report scale is called Inventory of Depressive Symptomatology, Self-Report (Abbreviated IDS-SR). IDS-SR Total Scores Range from 0 to 84, with a higher score reflecting greater depressive symptom severity. Paired t-test compares the change in mean total IDS-SR score from baseline (pre-TMS) to endpoint (last TMS session) or LOCF. A greater change reflects a better outcome than lesser change."|Baseline to final TMS session (up to 40 sessions over up to 8 weeks)|intent-to-treat population|||units on a scale||Standard Deviation|Mean
2591345|NCT02273063|Primary|Total Score on PTSD Checklist for DSM-5 (PCL-5)|"This self-report scale is called: PTSD Checklist for DSM-5 (abbreviated PCL-5) (see https://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp). Total PCL-5 score ranges from 0 to 80. Analysis of treatment effect on symptom severity will be evaluated by change in PCL-5 total score from baseline (pre-TMS) to endpoint (post-TMS)(or LOCF); Paired t-test compares the mean total PCL-score for the group at the two time points. A higher total score on the PCL-5 scale corresponds with more severe PTSD symptoms than a lower total score. A greater change from baseline to endpoint would correspond with better treatment outcome."|Baseline to final TMS session (up to 40 sessions over up to 8 weeks)|intent-to-treat population|||units on a scale||Standard Deviation|Mean
2591346|NCT02273050|Secondary|Patients Rescued for Failing to Achieve Pre-specified Glycemic Targets or Discontinuation for Lack of Efficacy During the 24-week Double-blind Treatment Phase|To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects requiring rescue for failing to achieve pre-specified glycemic targets or discontinuing for lack of efficacy within the 24 weeks of double-blinded treatment.|Baseline to Week 24|The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, and had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration.|||Percentage of patients|||Number
2591347|NCT02273050|Secondary|Change From Baseline to Week 24 in 120-minute Postprandial Glucose Response to a Meal Tolerance Test|To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to change in 120-minute postprandial glucose response to a meal tolerance test at the end of 24 weeks of double-blinded treatment.|Baseline to Week 24 prior to rescue|The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration, and participated in a meal tolerance test.|||mmol/L||Standard Error|Least Squares Mean
2591348|NCT02273050|Secondary|Glycemic Response Defined as HbA1c ≤ 6.5% at Week 24|To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects achieving a therapeutic glycemic response defined as HbA1c ≤ 6.5% at the end of 24 weeks of double-blinded treatment.|Week 24 (prior to rescue)|The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, and had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration.|||Percentage of patients|||Number
2591349|NCT02273050|Secondary|Change From Baseline to Week 24 (Prior to Rescue) in Area Under the Curve From 0-180 Minutes for Postprandial Glucose Response to a Meal Tolerance Test|To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to change in 180-minute postprandial glucose response to a meal tolerance test at the end of 24 weeks of double-blinded treatment.|Baseline to Week 24 prior to rescue|The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration, and participated in a meal tolerance test.|||mmol*min/L||Standard Error|Least Squares Mean
2591350|NCT02273050|Secondary|Change From Baseline to Week 24 (Prior to Rescue) in Fasting Plasma Glucose|To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to reduction in fasting plasma glucose at the end of 24 weeks of double-blinded treatment.|Baseline to Week 24 prior to rescue|The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, and had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration.|||mmol/L||Standard Error|Least Squares Mean
2591351|NCT02273050|Secondary|Glycemic Response Defined as HbA1c < 7.0% at Week 24|To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to the proportion of subjects achieving a therapeutic glycemic response defined as HbA1c < 7.0% at the end of 24 weeks of double-blinded treatment.|Week 24 (prior to rescue)|The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, and had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration.|||Percentage of patients|||Number
2591352|NCT02273050|Primary|Change From Baseline in HbA1c From Baseline to Week 24 Provided That it is Prior to Rescue|To evaluate the efficacy of the combination therapy (saxagliptin + metformin) when compared to placebo + metformin and placebo + saxagliptin with respect to reduction in HbA1c (%) at the end of 24 weeks of double-blinded treatment.|Baseline to Week 24 (prior to rescue)|The full analysis set consisted of patients who were randomized, took at least 1 randomized study medication, and had both a baseline and at least 1 post-baseline efficacy assessment for the time point under consideration.|||% HbA1c||Standard Error|Least Squares Mean
2591353|NCT02273037|Secondary|Cesarean Delivery (Includes Cesarean Delivery/Intra-uterine Resuscitation/Assisted Delivery)|"Compare the proportion of cesarean delivery between the Pinard and Doppler group.~(Includes Cesarean Delivery/Intra-uterine Resuscitation/Assisted delivery)"|Birth||||Participants|||Count of Participants
2591354|NCT02273037|Secondary|Identification of Abnormal Fetal Heart Rate|Compare the incidence of identification of abnormal fetal heart rate in labour in the Pinard and Doppler group.|In labour||||Participants|||Count of Participants
2591355|NCT02273037|Primary|Quality of Partograms|To assess the quality of partographs using a standardized scoring system to audit overall completion and quality, and fetal heart rate monitoring specifically. The investigators will compare the audit results between partographs in the Pinard and Doppler group.|in labour|||||||
2605749|NCT02107014|Primary|Change in IL-17A From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2591357|NCT02272985|Secondary|Change in rSO2 From Baseline (Before Start of the Hemodialysis Study Session), at 20 Minutes, and at the End of the Hemodialysis Study Session, Measured by NIRS|Change in rSO2, between baseline (-5 minutes) and the end of the hemodialysis (t=220 minutes) study session.|at t= -5 minutes, t= 20 minutes, and at t=220 minutes.The start of dialysis was considered as t=0. Therefore, baseline is t=-5minutes.||||percentage of regional oxygen saturation||95% Confidence Interval|Mean
2591358|NCT02272985|Primary|Change in CBF From Baseline (Before Start of the Hemodialysis Study Session), at 20 Minutes, and at the End of the Hemodialysis Study Session, Measured by [15O]H2OPET-CT||at t= -5 minutes, t= 20 minutes, and at t=220 minutes.The change from baseline (-5min) to the end of hemodialysis (220min) is reported.||||mL/100g/min||95% Confidence Interval|Least Squares Mean
2591359|NCT02272816|Secondary|Overall Survival|Survival status at 2 years after registration.|2 years|All participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2591360|NCT02272816|Secondary|Metabolic Response Rate|Number of participants achieving i) complete metabolic response (CR) and ii) partial metabolic response (PR) after one cycle of treatment.|21 days|All participants who completed one cycle of treatment and underwent PET-CT scan on day 17-21.|||Participants|||Count of Participants
2591361|NCT02272816|Primary|2 - Year Progression Free Survival|Number of participants progression free 2 years after registration.|2 years|All participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2591362|NCT02272803|Secondary|PFS Rate at 1 Year|The number of participants with PFS at 1 year post-randomization was divided by the total number randomized in that arm and expressed as a percentage. PFS was defined as the time from randomization to the date of the first documented tumor progression, as determined by the investigator using the IMWG response criteria, or to death due to any cause, provided death does not occur more than 10 weeks (2 or more assessment visits) after the last tumor assessment. Clinical deterioration will not be considered progression.|1 year|All randomized participants|||Percentage of participants||95% Confidence Interval|Number
2591363|NCT02272803|Secondary|Progression Free Survival (PFS) in Lenalidomide/Dexamethasone + Elotuzumab and Lenalidomide/Dexamethasone Therapy|PFS was defined as the time from randomization to the date of the first documented tumor progression, as determined by the investigator using the IMWG response criteria, or to death due to any cause, provided death does not occur more than 10 weeks (2 or more assessment visits) after the last tumor assessment. Clinical deterioration will not be considered progression.|From randomization to the date of first documented tumor progression or death due to any cause (assessed up to February 2017, approximately 24 months)|All randomized participants|||months||95% Confidence Interval|Median
2591364|NCT02272803|Secondary|Objective Response Rate (ORR) in All Treated Participants|"ORR is the proportion of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or PR as determined by investigator using the International Myeloma Working Group (IMWG) response criteria.~SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required."|From first dose until documented response (assessed up to February 2017, approximately 24 months)|All treated participants|||Percentage of participants||95% Confidence Interval|Number
2591365|NCT02272803|Primary|Objective Response Rate (ORR) of Participants Treated With Elotuzumab + Lenalidomide/Dexamethasone (E-Ld)|"ORR is the proportion of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or PR as determined by investigator using the International Myeloma Working Group (IMWG) response criteria.~SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required."|From first dose until documented response (assessed up to February 2017, approximately 24 months)|Participants treated with E-Ld|||Percentage of participants||70% Confidence Interval|Number
2591366|NCT02272790|Secondary|Multiple Dose Adavosertib Tmax|The time to reach maximum plasma concentration of adavosertib after multiple oral doses (Cycle 1 Day 3) in combination with IV infusion of 40 mg/m² pegylated liposomal doxorubicin.|Pre-dose, 1 hr, 2 hr, 4 hr, 6 hr, and 8 hr|The PK Analysis Set included all dosed patients who had at least one measurable plasma concentration collected post-dose which was obtained without any protocol deviation, violation, or other event which may have significantly affected the pharmacokinetics.|||hours||Full Range|Median
2591367|NCT02272790|Secondary|Single Dose Adavosertib Tmax|The time to reach maximum plasma concentration of adavosertib after a single oral dose (Cycle 1 Day 1) in combination with IV infusion of commonly used chemotherapy agents, including gemcitabine, paclitaxel, and carboplatin.|Pre-dose, 0.5 hr, 1 hr, 2 hr, 4 hr, 6 hr, and 8 hr|The PK Analysis Set included all dosed patients who had at least one measurable plasma concentration collected post-dose which was obtained without any protocol deviation, violation, or other event which may have significantly affected the pharmacokinetics.|||hours||Full Range|Median
2591368|NCT02272790|Secondary|Multiple Dose Adavosertib Cmax|Maximum plasma concentration of adavosertib after a multiple oral doses (Cycle 1 Day 3) in combination with IV infusion of 40 mg/m² pegylated liposomal doxorubicin.|Pre-dose, 1 hr, 2 hr, 4 hr, 6 hr, and 8 hr|The PK Analysis Set included all dosed patients who had at least one measurable plasma concentration collected post-dose which was obtained without any protocol deviation, violation, or other event which may have significantly affected the pharmacokinetics.|||nM||Geometric Coefficient of Variation|Geometric Mean
2591425|NCT02271945|Secondary|Terminal Half-Life (t1/2) of MEDI0680|Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.|EOI of Cycle 1 Day 2; Pre-dose and EOI of C1D15, C2D1, C3D1 and C4D1|As-treated Population included all participants who were treated with study drug.|||h||Full Range|Median
2591369|NCT02272790|Secondary|Single Dose Adavosertib Cmax|Maximum plasma concentration of adavosertib after a single oral dose (Cycle 1 Day 1) in combination with IV infusion of commonly used chemotherapy agents, including gemcitabine, paclitaxel, and carboplatin.|Pre-dose, 0.5 hr, 1 hr, 2 hr, 4 hr, 6 hr, and 8 hr|The PK Analysis Set included all dosed patients who had at least one measurable plasma concentration collected post-dose which was obtained without any protocol deviation, violation, or other event which may have significantly affected the pharmacokinetics.|||nM||Geometric Coefficient of Variation|Geometric Mean
2591370|NCT02272790|Secondary|Treatment-Related Adverse Events Related to Chemotherapy Leading to Treatment Interruption|The number of patients experiencing at least one treatment-related adverse event related to chemotherapy leading to treatment interruption.|Throughout the duration of the study (up to 19 months)|This analysis was conducted on the Full Analysis Set, comprised of all patients who received at least dose of study treatment (n = 94).|||Participants|||Number
2591371|NCT02272790|Secondary|Treatment-Related Adverse Events Related to Chemotherapy Leading to Dose Reduction|The number of patients experiencing at least one treatment-related adverse event related to chemotherapy leading to dose reduction.|Throughout the duration of the study (up to 19 months)|This analysis was conducted on the Full Analysis Set, comprised of all patients who received at least dose of study treatment (n = 94).|||Participants|||Number
2591372|NCT02272790|Secondary|Treatment-Related Adverse Events Related to Chemotherapy Leading to Treatment Discontinuation|The number of patients experiencing at least one treatment-related adverse event related to chemotherapy leading to treatment discontinuation.|Throughout the duration of the study (up to 19 months)|This analysis was conducted on the Full Analysis Set, comprised of all patients who received at least dose of study treatment (n = 94).|||Participants|||Number
2591373|NCT02272790|Secondary|Treatment-Related Adverse Events Related to Adavosertib Leading to Treatment Interruption|The number of patients experiencing at least one treatment-related adverse event related to adavosertib leading to treatment interruption.|Throughout the duration of the study (up to 19 months)|This analysis was conducted on the Full Analysis Set, comprised of all patients who received at least dose of study treatment (n = 94).|||Participants|||Number
2591374|NCT02272790|Secondary|Treatment-Related Adverse Events Related to Adavosertib Leading to Dose Reduction|The number of patients experiencing at least one treatment-related adverse event related to adavosertib leading to dose reduction.|Throughout the duration of the study (up to 19 months)|This analysis was conducted on the Full Analysis Set, comprised of all patients who received at least dose of study treatment (n = 94).|||Participants|||Number
2591375|NCT02272790|Secondary|Treatment-Related Adverse Events Related to Adavosertib Leading to Treatment Discontinuation|The number of patients experiencing at least one treatment-related adverse event related to adavosertib leading to treatment discontinuation.|Throughout the duration of the study (up to 19 months)|This analysis was conducted on the Full Analysis Set, comprised of all patients who received at least dose of study treatment (n = 94).|||Participants|||Number
2591376|NCT02272790|Secondary|Serious Adverse Events Leading to Death|The number of patients experiencing at least one serious adverse event (SAE) leading to death.|Throughout the duration of the study (up to 19 months)|This analysis was conducted on the Full Analysis Set, comprised of all patients who received at least dose of study treatment (n = 94).|||Participants|||Number
2591377|NCT02272790|Secondary|Serious Adverse Events|The number of patients experiencing at least one serious adverse event (SAE).|Throughout the duration of the study (up to 19 months)|This analysis was conducted on the Full Analysis Set, comprised of all patients who received at least dose of study treatment (n = 94).|||Participants|||Number
2591378|NCT02272790|Secondary|The Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) Related to Chemotherapy by Maximum CTCAE Grade|"The number of patients experiencing at least one treatment-related adverse event (TEAE) related to chemotherapy by maximum CTCAE grade.~Severity Grade 1 = Mild; Severity Grade 2 = Moderate; Severity Grade 3 = Severe; Severity Grade 4 = Life Threatening; Severity Grade 5 = Fatal"|Throughout the duration of the study (up to 19 months)|This analysis was conducted on the Full Analysis Set, comprised of all patients who received at least dose of study treatment (n = 94).|||Participants|||Number
2591379|NCT02272790|Secondary|The Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) Related to Adavosertib by Maximum CTCAE Grade|"The number and proportion of patients experiencing at least one treatment-related adverse event (TEAE) related to adavosertib by maximum CTCAE grade~Severity Grade 1 = Mild; Severity Grade 2 = Moderate; Severity Grade 3 = Severe; Severity Grade 4 = Life Threatening; Severity Grade 5 = Fatal"|Throughout the duration of the study (up to 19 months)|This analysis was conducted on the Full Analysis Set, comprised of all patients who received at least dose of study treatment (n = 94).|||Participants|||Number
2591380|NCT02272790|Secondary|The Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) by Maximum CTCAE Grade.|"The number of patients experiencing at least one treatment-related adverse event (TEAE) by maximum CTCAE grade.~Severity Grade 1 = Mild; Severity Grade 2 = Moderate; Severity Grade 3 = Severe; Severity Grade 4 = Life Threatening; Severity Grade 5 = Fatal"|Throughout the duration of the study (up to 19 months)|This analysis was conducted on the Full Analysis Set, comprised of all patients who received at least dose of study treatment (n = 94).|||Participants|||Number
2591381|NCT02272790|Secondary|Gynecologic Cancer Intergroup (GCIG) CA-125 Response|The GCIG CA-125 response is defined as the proportion of patients achieving a 50% reduction in CA-125 levels from baseline, if baseline level is ≥2 x the upper limit of normal (ULN) within 2 weeks prior to starting treatment. Response must be confirmed and maintained for at least 28 days.|Throughout the study, approximately 4 years|The CA-125 analysis set was comprised of all dosed patients with pre-treatment serum sample showing CA-125 ≥ 2 x ULN within 2 weeks before starting treatment.|||Percent||90% Confidence Interval|Number
2591382|NCT02272790|Secondary|Overall Survival (Median, 95% CI)|Overall survival (OS) was defined as the elapsed time from the date of first dose of AZD1775 until death due to any cause. Any patient not known to have died at the time of the analysis was censored based on the last recorded date on which the patient was known to be alive.|Throughout the Study, Approximately 4 years|This analysis was conducted on the Full Analysis Set, comprised of all patients who received at least dose of study treatment (n = 94).|||Months||95% Confidence Interval|Median
2605750|NCT02107014|Primary|Change in IL-15 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2591383|NCT02272790|Secondary|Overall Survival (Median, 80% CI)|Overall survival (OS) was defined as the elapsed time from the date of first dose of AZD1775 until death due to any cause. Any patient not known to have died at the time of the analysis was censored based on the last recorded date on which the patient was known to be alive.|Throughout the Study, Approximately 4 years|This analysis was conducted on the Full Analysis Set, comprised of all patients who received at least dose of study treatment (n = 94).|||Months||80% Confidence Interval|Median
2591384|NCT02272790|Secondary|Progression Free Survival (Median, 95% CI)|"Progression-free survival (PFS) was defined as the elapsed time from date of first dose of AZD1775 until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment.~Progression-free survival was derived based on scan/assessment dates, not visit dates."|Throughout the Study, Approximately 4 years|This analysis was conducted on the Full Analysis Set, comprised of all patients who received at least dose of study treatment (n = 94).|||Months||95% Confidence Interval|Median
2591385|NCT02272790|Secondary|Progression Free Survival (Median, 80% CI)|"Progression-free survival (PFS) was defined as the elapsed time from date of first dose of AZD1775 until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment.~Progression-free survival was derived based on scan/assessment dates, not visit dates."|Throughout the Study, Approximately 4 years|This analysis was conducted on the Full Analysis Set, comprised of all patients who received at least dose of study treatment (n = 94).|||Months||80% Confidence Interval|Median
2591386|NCT02272790|Secondary|Duration of Response (DoR)|Duration of Response (DoR) is defined as the time from first documented tumour response until the date of documented progression or death from any cause.|Throughout the duration of the study, approximately 19 months.|Duration of Response (DoR) was calculated for all responders (N = 30)|||Months||95% Confidence Interval|Median
2591387|NCT02272790|Secondary|Disease Control Rate (DCR)|The Disease Control Rate is defined as the proportion of patients achieving a complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1 criteria.|Throughout the duration of the study (up to 19 months)|This analysis was conducted on the Full Analysis Set, comprised of all patients who received at least dose of study treatment (n = 94).|||Participants|||Number
2591388|NCT02272790|Primary|Objective Response Rate (ORR)|Objective response rate is defined as the proportion of patients achieving a complete or partial tumour response according to RECIST v1.1 criteria.|Throughout the duration of the study (up to 19 months)|This analysis was conducted on the Full Analysis Set, comprised of all patients who received at least dose of study treatment (n = 94).|||Participants|||Number
2591389|NCT02272777|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Clinically significant changes in laboratory values and vital signs were reported as AEs or SAEs, as appropriate. Only descriptive analysis.|From first dose of study treatment to 30 days after last dose of study treatment, up to 31 months||||Participants|||Count of Participants
2591390|NCT02272725|Secondary|Exercise-Associated Hyponatremia|The count of participants experiencing exercise-associated hyponatremia (defined as < 135 mEq) will be estimated from measured point-of-care blood test at the finish line immediately following completion of a 50 mile ultramarathon. This outcome measure is a biochemical reading, that may not necessarily be a clinical adverse event.|participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours||||Participants|||Count of Participants
2591391|NCT02272725|Secondary|Perceived Exertion|A Borg score of perceived exertion will be measured at the finish line immediately following completion of a 50 mile ultramarathon to measure what affect ibuprofen had on perceived exertion as analgesia may have made the endurance event perceived as less exertional. Scores range from 7 - 20, with higher scores indicative of greater amount of exertion.|participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours||||units on a scale||Standard Deviation|Mean
2591392|NCT02272725|Primary|Acute Kidney Injury|The participants experiencing acute kidney injury (diagnosed by an increase in creatinine of greater or equal to 1.5x that of estimated baseline creatinine from age and weight) will be from measured point-of-care blood test of the finish line immediately following the completion of a 50 mile ultramarathon. This outcome measure is a biochemical reading, that may not necessarily be a clinical adverse event.|participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours||||Participants|||Count of Participants
2591393|NCT02272686|Secondary|Overall Survival (OS)|Participants will be assessed at 3 year time point for survival.|Three Years||||Participants|||Count of Participants
2591394|NCT02272686|Primary|Disease Free Survival (DFS)|Participants will be assessed for disease status and survival.|Two years||||Participants|||Count of Participants
2591395|NCT02272413|Secondary|Duration of Response (DOR) as Determined by Investigator Assessment|DOR was the time from first documented CR or PR until time of progression as determined by Investigator assessment during the pre-switch period. Tumor assessments were performed prior to trial drug administration. DOR was calculated using the Kaplan-Meier technique.|Tumor scans performed at baseline, Cycle 3 (Week 6), Cycle 5 (Week 12), Cycle 7 (Week 18), then every 3 cycles (~9 weeks) until confirmed disease progression., ie up to 35 cycles (105 weeks).|The FAS contained all randomized patients who received at least 1 dose of trial drug and who had a baseline tumor assessment. Only patients with an objective response were included in the analysis.|||Months||95% Confidence Interval|Median
2591396|NCT02272413|Secondary|Overall Survival (OS) Time|OS was defined as the time randomization until death from any cause during the pre-switch period. OS was calculated using the Kaplan-Meier technique.|From baseline until death due to any cause, ie., up to 35 cycles (105 weeks).|The FAS contained all randomized patients who received at least 1 dose of trial drug and who had a baseline tumor assessment.|||Months||95% Confidence Interval|Median
2593565|NCT02244619|Post-Hoc|Post-Anesthesia Care Unit (PACU) Length of Stay, Hours|PACU length of stay was calculated as (PACU discharge moment - PACU admit moment). PACU length of stay is reported in hours.|PACU admission time until PACU discharge time||||Hours||Inter-Quartile Range|Median
2591397|NCT02272413|Secondary|Progression-Free Survival (PFS) Time as Determined by Investigator Assessment|PFS was defined as the time from randomization until disease progression as determined by Investigator assessment or death from any cause, whichever occurred first during the pre-switch period. Disease progression was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 millimeters. Tumor assessments were performed prior to trial drug administration. PFS was calculated using the Kaplan-Meier technique.|Tumor scans performed at baseline, Cycle 3 (Week 6), Cycle 5 (Week 12), Cycle 7 (Week 18), then every 3 cycles (~9 weeks) until confirmed disease progression. Analysis performed for pre-switch period only; maximum duration of up to 35 cycles (105 weeks).|The Full Analysis Set (FAS) contained all randomized patients who received at least 1 dose of trial drug and who had a baseline tumor assessment.|||Months||95% Confidence Interval|Median
2591398|NCT02272413|Secondary|Percentage of Patients With Selected Treatment-Emergent Adverse Events (TEAEs) For Comparability Assessment of BI 695502 and US-licensed Avastin®|"The following selected adverse events (AEs) were evaluated for comparability assessment of BI 695502 and US-licensed Avastin®:~Infusion reactions (anaphylactic/hypersensitivity/infusion-related reactions),~Thromboembolic events (arterial or venous),~Febrile neutropenia,~Gastrointestinal perforations,~Hypertension,~Proteinuria,~Pulmonary hemorrhage,~Other hemorrhages (not including pulmonary hemorrhages),~Wound-healing complications/abscess/fistulas. The analysis of AEs was based on the concept of TEAEs. For non-switched patients, all AEs that started or worsened in severity on or after the first dose of trial drug and prior to the date of last administration of trial medication + 16 weeks inclusive were defined as TEAEs."|From first dose of trial drug until 16 weeks after the last dose of trial medication, up to 218 days.|The Treated Set contained all patients who signed informed consent and who received at least one dose of trial drug.|||Percentage of patients (%)||95% Confidence Interval|Number
2591399|NCT02272413|Primary|Best Overall Response Rate (ORR), Based on Unconfirmed Response Assessment, as Assessed by Central Imaging Review Until 18 Weeks After the Start of Treatment|ORR was defined as the percentage of patients who achieved at least one visit response of complete response (CR) or partial response (PR) after the start of treatment. The response criteria evaluation was carried out according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. CR and PR did not need to be confirmed by a subsequent tumor assessment due to blinded central assessment. CR: Disappearance of all target lesions since baseline; PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Tumor assessments were performed prior to trial drug administration, until 18 weeks.|Tumor assessment scans were performed at baseline, Cycle 3 (Week 6), Cycle 5 (Week 12) and at Week 18 ±14 days. Best ORR evaluated until confirmed disease progression, unacceptable toxicity, death or up to 18 weeks, whichever happened earlier.|The FAS contained all randomized patients who received at least 1 dose of trial drug and who had a baseline tumor assessment. Best ORR (CR+PR) is reported for observed values.|||Percentage of patients (%)|||Number
2591400|NCT02272244|Secondary|Screening Knowledge and Perceptions|Knowledge and perceptions (Preventive Health Model scales) about CRC and screening will be assessed in a 6-month survey. Knowledge was measured by a set of 10 true-false statements about CRC and CRC screening. Knowledge was scored as the number of items correct with a possible range of 0 to 10. Perceptions about CRC and screening were measured using a 20-item scale based on the Preventive Health Model. Items were measured on a 5 point Likert scale ranging from 1 = Strongly Disagree to 5 = Strongly Agree. The total score and subscale scores were computed by taking the mean of component items resulting in scores that could range from 1 to 5, with higher scores indicating more favorable attitudes towards the CRC screening preventive health behavior.|6 months|Participants with complete baseline and 6-month survey data.|||units on a scale||Standard Deviation|Mean
2591401|NCT02272244|Secondary|Test Specific Screening Adherence|Test adherence (SBT or endoscopy) will be assessed using 6-month survey and 12-month medical records data. The two study groups will be compared in terms of the fraction of participants who have a screening test within 12 months.|12 Months|All randomized participants.|||Participants|||Count of Participants
2591402|NCT02272244|Secondary|Change in Screening Decision Stage|"At baseline and endpoint (6-month) survey, participants were asked about their decision stage regarding CRC screening. Possible decision stages are, ranked from lowest to highest stage: Decided not to do, Not considering, Haven't decided, Decided to Do and Done, with Done only possible at endpoint."|6 months|Participants with complete baseline and endpoint survey data|||Participants|||Count of Participants
2591403|NCT02272244|Primary|Overall Screening Adherence|The two study groups will be compared in terms of the fraction of participants who undergo CRC screening (through SBT, colonoscopy, flexible sigmoidoscopy, etc.) within 12 months of the randomization date. Screening will be measured using data from the 6-month survey and the 12-month chart audit.|12 months||||Participants|||Count of Participants
2591404|NCT02271984|Secondary|Number of Subjects With Clinical Significant Laboratory Abnormalities, Electrocardiogram (ECG), Physical Examination and Vital Signs Reported as Treatment Emergent Adverse Events|Any clinically significant changes in laboratory evaluations ECGs,physical examination (body weight) and vital signs (temperature, blood pressure, pulse rate) were recorded as treatment emergent adverse events. Following parameters were analyzed for laboratory examination: hematology (haemoglobin, hematocrit, red blood cell count, mean cell hemoglobin [MCH], MCH concentration, mean cell volume, white cell count, platelets, neutrophils, lymphocytes, monocytes, eosinophils, Basophils); serum chemistry (sodium, potassium, calcium, inorganic phosphate, creatinine, total protein, albumin, urea, uric acid, aspartate aminotransferase [AST], alanine aminotransferase [ALT] gamma glutamyl transpeptidase, total bilirubin, alkaline phosphatase, glucose, triglycerides cholesterol); urinalysis (protein, glucose, ketones, pH, blood, leukocytes, nitrite); The 12-lead ECGs were recorded after the subjects had rested for at least 5 minutes in supine position.|From the first dose of study drug administration up to 3-10 days after the last dose of the study drug (up to a maximum of 7 weeks)|The safety analysis set consisted of all subjects who received at least one dose of the trial medication and who had follow-up safety assessments.|||Subjects|||Number
2591426|NCT02271945|Secondary|Terminal Half-Life (t1/2) of MEDI551|Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum.|EOI of Cycle 1 Day 1; Pre-dose and EOI of C1D8, C2D1, C3D1 and C4D1|As-treated Population included all participants who were treated with study drug.|||h||Full Range|Mean
2591405|NCT02271984|Secondary|Palatability Score|"Each administration was assessed at 0 minutes on Day 1 for flavor, smell, sweetness, overall liking of the medicine and at 2-5 minutes on Day 1 for taste in mouth and acceptability to swallow using a modified 100 millimeter (mm), visual analog scale (VAS) incorporating a facial hedonic scale, where lower score (0) indicates not acceptable/not liked at all and higher score (100) indicates very acceptable/liked very much."|0 min for flavor, smell, sweetness, overall liking; 2-5 minutes post dose for taste in mouth and acceptability on Day 1|The safety analysis set consisted of all subjects who received at least one dose of the trial medication and who had follow-up safety assessments.|||millimeter (mm)||Standard Deviation|Mean
2591406|NCT02271984|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation|An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were adverse events that occurred between the first dose of study drug and up to 3-10 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Subjects who discontinued and who died due to TEAEs were also reported.|From the first dose of study drug administration up to 3-10 days after the last dose of the study drug (up to a maximum of 7 weeks)|The safety analysis set consisted of all subjects who received at least one dose of the trial medication and who had follow-up safety assessments.|||Subjects|||Number
2591407|NCT02271984|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/f) of L-Praziquantel (L-PZQ)|The Vz/f was defined as the theoretical volume in which the total amount of L-PZQ required to uniformly distribute to produce the desired plasma concentration of L-PZQ. Apparent volume of distribution after oral dose (Vz/F) was influenced by the fraction absorbed. The Vz/f was calculated by dividing the dose with area under the concentration time curve from time zero to infinity multiplied with terminal elimination rate constant (lambda z) (Vz/f=Dose/( AUC0-inf* lambda z).|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|PK population: all randomized subjects treated according to protocol without relevant violations with respect to factors likely to affect comparability of PK results & availability of AUC0-inf for MSC2499550A in periods 1 & 2. Number of “participants analyzed” below (Measured Values) reflects number of participants with non-missing values.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2591408|NCT02271984|Secondary|Apparent Total Body Clearance of Drug From Plasma (CL/f) of L-Praziquantel (L-PZQ)|The CL/f of L-PZQ was a measure of the rate at which it was metabolized or eliminated by normal biological processes. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed. The CL/F of L-PZQ from plasma was calculated using the formula: Dose divided by area under the concentration time curve from time zero to infinity (AUC0-inf).|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|PK population: all randomized subjects treated according to protocol without relevant violations with respect to factors likely to affect comparability of PK results & availability of AUC0-inf for MSC2499550A in periods 1 & 2. Number of “participants analyzed” below (Measured Values) reflects number of participants with non-missing values.|||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
2591409|NCT02271984|Secondary|Apparent Terminal Elimination Rate Constant (Lambda Z) of L-Praziquantel (L-PZQ)|The lambda z was calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|PK population: all randomized subjects treated according to protocol without relevant violations with respect to factors likely to affect comparability of PK results & availability of AUC0-inf for MSC2499550A in periods 1 & 2. Number of “participants analyzed” below (Measured Values) reflects number of participants with non-missing values.|||per hour (1/hour)||Geometric Coefficient of Variation|Geometric Mean
2591410|NCT02271984|Secondary|Relative Bioavailability (Frel) of L-Praziquantel (L-PZQ)|Relative bioavailability (Frel) was calculated for L-PZQ only (treatment A versus treatment B) using the formula: Frel = (AUC0-inf (test or Treatment A)/AUC0-inf (reference or treatment B)) multiplied by 100.|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|The PK population included all randomized subjects who were treated according to the protocol without relevant protocol violations with respect to factors likely to affect the comparability of PK results and the availability of the primary target variable AUC0-inf for MSC2499550A in periods 1 and 2.|||Percentage bioavailability||95% Confidence Interval|Geometric Mean
2591411|NCT02271984|Secondary|Apparent Terminal Half-life (T1/2) of L-Praziquantel (L-PZQ)|The apparent terminal half-life was calculated by dividing natural log 2 with lambda z (ln2/lambda Z); where lambda Z is the terminal rate constant.|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|PK population: all randomized subjects treated according to protocol without relevant violations with respect to factors likely to affect comparability of PK results & availability of AUC0-inf for MSC2499550A in periods 1 & 2. Number of “participants analyzed” below (Measured Values) reflects number of participants with non-missing values.|||hour||Full Range|Median
2591412|NCT02271984|Secondary|Maximum Observed Concentration in Plasma (Cmax) of L-Praziquantel (L-PZQ) After Dose Adjustment||Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|The PK population included all randomized subjects who were treated according to the protocol without relevant protocol violations with respect to factors likely to affect the comparability of PK results and the availability of the primary target variable AUC0-inf for MSC2499550A in periods 1 and 2.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2591424|NCT02271945|Secondary|Number of Participants With Positive Anti-Drug Antibodies (ADA) for MEDI-551 and MEDI0680|A participant was considered ADA-positive across the study if they had a positive reading (titer of 50 or higher) at any time point during the study.|30 min prior to infusion of MEDI-551 on Day 1 of Cycles 1, 2, 6, 9, and 12 and up to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug.|||Participants|||Number
2593566|NCT02244619|Other Pre-specified|Time to First Rescue Opioid (PRN Order)||During post-op period up to 24 hrs after surgery||||Minutes||Inter-Quartile Range|Median
2591413|NCT02271984|Secondary|Extrapolated Area Under the Concentration Time Curve (AUC) From Time Tlast to Infinity Given as Percentage From AUC0-inf (AUCextra) of L-Praziquantel (L-PZQ)|Extrapolated AUC from time tlast to infinity given as percentage from AUC0-inf. AUCextra =(last predicted concentration [Clast pred] divided by terminal elimination rate constant [lambda z]) divided by AUC0-inf., where Clast pred is the last predicted concentration.|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|PK population: all randomized subjects treated according to protocol without relevant violations with respect to factors likely to affect comparability of PK results & availability of AUC0-inf for MSC2499550A in periods 1 & 2. Number of “participants analyzed” below (Measured Values) reflects number of participants with non-missing values.|||Percent extrapolated||Geometric Coefficient of Variation|Geometric Mean
2591414|NCT02271984|Secondary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of L-Praziquantel (L-PZQ) After Dose Adjustment|The AUC (0-t) was defined as the area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration at or above the lower limit of quantification (AUC0-t) of L-PZQ.|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|The pharmacokinetic (PK) population included all randomized subjects who were treated according to the protocol without relevant protocol violations with respect to factors likely to affect the comparability of PK results and the availability of the primary target variable AUC0-inf for MSC2499550A in periods 1 and 2.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2591415|NCT02271984|Secondary|Time Prior to the First Measurable (Non-zero) Concentration (Tlag) of L-Praziquantel (L-PZQ)|Time prior to the first measurable (non-zero) concentration (tlag) of drug L-PZQ|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|The pharmacokinetic (PK) population included all randomized subjects who were treated according to the protocol without relevant protocol violations with respect to factors likely to affect the comparability of PK results and the availability of the primary target variable AUC0-inf for MSC2499550A in periods 1 and 2.|||hour||Full Range|Median
2591416|NCT02271984|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of L-Praziquantel (L-PZQ)||Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|The pharmacokinetic (PK) population included all randomized subjects who were treated according to the protocol without relevant protocol violations with respect to factors likely to affect the comparability of PK results and the availability of the primary target variable AUC0-inf for MSC2499550A in periods 1 and 2.|||hour||Full Range|Median
2591417|NCT02271984|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-inf) Adj of L-Praziquantel (L-PZQ) After Dose Adjustment|The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.|Pre-dose, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 8.0, 12.0, 16 and 24 hours post-dose|PK population: all randomized subjects treated according to protocol without relevant violations with respect to factors likely to affect comparability of PK results & availability of AUC0-inf for MSC2499550A in periods 1 & 2. Number of “participants analyzed” below (Measured Values) reflects number of participants with non-missing values.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2591418|NCT02271945|Secondary|Time to Response (TTR)|Time to response (TTR) defined as the time from the start of study drug administration until the first documentation of disease response. Only participants who have achieved objective response (confirmed CR or confirmed PR) assessed by investigator were evaluated for TTR.|From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug. This parameter was not analyzed as study was discontinued before sufficient data could be collected.||||||
2591419|NCT02271945|Secondary|Overall Survival (OS)|Overall survival defined as the time from the start of study drug administration until death due to any cause.|From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug. This parameter was not analyzed as study was discontinued before sufficient data could be collected.||||||
2591420|NCT02271945|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined as the time from the start of study drug administration until the first documentation of disease progression or death due to any cause, whichever occurs first.|From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug. This parameter was not analyzed as study was discontinued before sufficient data could be collected.||||||
2591421|NCT02271945|Secondary|Duration of Disease Control|Duration of disease control is defined as the time period from the start of disease control event to the event of disease progression.|From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug. This parameter was not analyzed as study was discontinued before sufficient data could be collected.||||||
2591422|NCT02271945|Secondary|Number of Participants With Disease Control|Disease control includes CR (disappearance of all evidence of disease), PR (regression of measurable disease and no new sites), or SD for at least 8 weeks.|From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug. This parameter was not analyzed as study was discontinued before sufficient data could be collected.||||||
2591423|NCT02271945|Secondary|Duration of Complete Response|Duration of Complete Response defined as time from start of first documented Complete Response [CR] to the time of disease progression or death, whichever occurs first. Only participants who have achieved complete response assessed by investigator were evaluated.|From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug. This parameter was not analyzed as study was discontinued before sufficient data could be collected.||||||
2591459|NCT02271477|Secondary|Time of Procedures|Time employed to execute all procedure from the start of the study till 30 minutes after the end of the procedure|From time 0 to 30 minutes after spinal anesthesia||||minutes||Standard Deviation|Mean
2591427|NCT02271945|Secondary|Mean Peak and Trough Concentrations of MEDI0680|The mean peak and Trough concentration of MEDI0680 were observed. Peak is the end of infusion measurement and the Trough is the pre-dose measurement.|EOI of Cycle 1 Day 2; Pre-dose and EOI of C1D15, C2D1, C3D1 and C4D1|As-treated Population included all participants who were treated with study drug.|||mcg/mL||Standard Deviation|Mean
2591428|NCT02271945|Secondary|Mean Peak and Trough Concentrations of MEDI551|The mean peak and Trough concentration of MEDI551 were observed. Peak is the end of infusion measurement and the Trough is the pre-dose measurement.|End of Infusion (EOI) of Cycle 1 Day 1; Pre-dose and EOI of C1D8, C2D1, C3D1 and C4D1|As-treated Population included all participants who were treated with study drug.|||mcg/mL||Standard Deviation|Mean
2591429|NCT02271945|Primary|Number of Participants With Best Overall Response|The best overall response was calculated, based upon the disease assessments recorded during the study visits, and summarized with the number of participants for the following categories: complete response (disappearance of all evidence of disease), partial response (regression of measurable disease and no new sites), stable disease (SD), progessive disease (PD), and non- evaluable (NE).|Day 1 to Day 28 of Cycle 13 (28-day cycle)|As-treated Population included all participants who were treated with study drug.|||Participants|||Count of Participants
2591430|NCT02271945|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs, Physical Findings Abnormalities|Vital signs included parameters such as blood pressure, temperature, respiratory rate, and pulse oximetry. An abnormal vital signs and physical findings that was judged by the investigator to be medically significant was reported an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, for the period extending to 90 days after the end of study treatment.|From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug.|||Participants|||Count of Participants
2591431|NCT02271945|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities|An abnormal laboratory findings that was judged by the investigator to be medically significant was reported as an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, for the period extending to 90 days after the end of study drug.|From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug.|||Participants|||Count of Participants
2591432|NCT02271945|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Treatment-Emergent Serious Adverse Events (TESAEs)|An Adverse Event (AE) is any unfavourable and unintended signs, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. SAE is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, life-threatening, a congenital anomaly/birth defect, or an important medical event. TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 90 days after the end of treatment (EOT).|From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)|As-treated Population included all participants who were treated with study drug.|||Participants|||Count of Participants
2591433|NCT02271945|Primary|Maximum Tolerated Dose (MTD) of MEDI-551|The Maximum Tolerated Dose, defined as the highest dose where less than or equal to (<= 1) out of 6 subjects experiences a dose limiting toxicity (DLT) during the DLT evaluation period (Day 1 to Day 28 of Cycle 1) or the highest protocol specified dose not exceeding MTD.|Day 1 to Day 28 of Cycle 1 (28-day cycle)|Evaluable Population for DLT included all participants in the dose escalation portion who received all protocol assigned doses and completed safety follow-up during the first 28-day period of therapy, or experienced a DLT during the DLT evaluation period.|||mg/kg|||Number
2591434|NCT02271906|Secondary|Number of Participants With a Change in Standard Uptake Value (SUV) From Pre to Post Operative PET-CT|To determine whether pre-operative Afatinib treatment affects metabolic tumor labeling, as measured by PET-CT scanning.|From the start of neoadjuvant treatment to follow-up, up to 30 days post surgery||||Participants|||Count of Participants
2591435|NCT02271906|Primary|"Number of Patients With Treatment Completed"|"A patient is declared to have the treatment completed if he completes at least 14 days of neoadjuvant treatment, had a thoracotomy for the planned surgical resection, and 30 days of post operative care."|From the start of neoadjuvant treatment to 30 days post operative care||||Participants|||Count of Participants
2591436|NCT02271880|Secondary|Followup Medication Adherence|Continued monitoring of prescribed doses taken over 12-month followup period|30 months|Data were not collected.||||||
2591437|NCT02271880|Secondary|Maintenance of Medication Adherence|Continued monitoring of prescribed doses taken over 12-month monitoring period|18 months|Data were not collected.||||||
2591438|NCT02271880|Secondary|Impairment Rating Scale - Adolescent Report|Scores represent the average adolescent self-report rating of adolescent functional impairment across multiple domains of functioning (i.e., home, school, peer relationships). Possible scores range from 0 to 6 with higher scores indicating more severe impairment and need for treatment.|Posttreatment (6 months)||||score on a scale||Standard Deviation|Mean
2591439|NCT02271880|Secondary|Impairment Rating Scale - Parent Report|Scores represent the average parent rating of adolescent functional impairment across multiple domains of functioning (i.e., home, school, peer relationships). Possible scores range from 0 to 6 with higher scores indicating more severe impairment and need for treatment.|Posttreatment (6 months)||||score on a scale||Standard Deviation|Mean
2591440|NCT02271880|Secondary|Disruptive Behavior Disorder Rating Scale - Adolescent Report: Conduct Disorder Symptoms|Scores represent the total number of self-reported adolescent symptoms of conduct disorder (CD) endorsed on this rating scale. Scores range from 0 to 15 with higher scores indicating the presence of more symptoms of CD.|Posttreatment (6 months)||||score on a scale|||Number
2591441|NCT02271880|Secondary|Disruptive Behavior Disorder Rating Scale - Adolescent Report: Oppositional Defiant Disorder Symptoms|Scores represent the total number of adolescent self-reported symptoms of oppositional defiant disorder (ODD) symptoms endorsed on this rating scale. Possible scores range from 0 to 8 with higher scores indicating the presence of more symptoms of ODD.|Posttreatment (6 months)||||score on a scale|||Number
2591442|NCT02271880|Secondary|Disruptive Behavior Disorder Rating Scale - Adolescent Report: Hyperactive-Impulsive Symptoms|Scores represent the total number of adolescent self-reported hyperactive-impulsive symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) endorsed on this rating scale. Possible scores range from 0 to 9 with higher scores representing the presence of more symptoms of hyperactivity-impulsivity.|Posttreatment (6 months)||||score on a scale||Standard Deviation|Mean
2591443|NCT02271880|Secondary|Disruptive Behavior Disorder Rating Scale - Adolescent Report|Scores represent the total number of self-reported adolescent inattention symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) endorsed on this rating scale. Possible scores range from 0 to 9 with higher scores representing the presence of more symptoms of inattention.|Posttreatment (6 months)||||score on a scale||Standard Deviation|Mean
2591444|NCT02271880|Secondary|Disruptive Behavior Disorder Rating Scale - Parent Report: Conduct Disorder Symptoms|Scores represent the total number of adolescent symptoms of conduct disorder (CD) endorsed by parent on this rating scale. Possible scores range from 0 to 15 with higher scores representing the presence of more symptoms of conduct disorder.|Posttreatment (6 months)||||score on a scale||Standard Deviation|Mean
2591445|NCT02271880|Secondary|Disruptive Behavior Disorder Rating Scale - Parent Report: Oppositional Defiant Disorder (ODD) Symptoms|Scores represent the total number of adolescent symptoms of oppositional defiant disorder (ODD) endorsed by parent on this rating scale. Possible scores range from 0 to 8 with higher scores representing the presence of more symptoms of ODD.|Posttreatment (6 months)||||score on a scale||Standard Deviation|Mean
2591446|NCT02271880|Secondary|Disruptive Behavior Disorder Rating Scale - Parent Report: Hyperactive-Impulsive|Scores represent the total number of adolescent hyperactive-impulsive symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) endorsed by parent on this rating scale. Possible scores range from 0 to 9 with higher scores representing the presence of more symptoms of hyperactivity-impulsivity.|Posttreatment (6 months)||||score on a scale||Standard Deviation|Mean
2591447|NCT02271880|Secondary|Disruptive Behavior Disorder Rating Scale - Parent Report: Inattention|Scores represent the total number of adolescent inattention symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) endorsed by parent on this rating scale. Possible scores range from 0 to 9 with higher scores representing the presence of more symptoms of inattention.|Posttreatment (6 months)||||score on a scale||Standard Deviation|Mean
2591448|NCT02271880|Primary|Medication Adherence|Proportion of prescribed doses taken as measured by electronic monitoring devices.|Posttreatment (6 months)||||Past 30 day proportion adherence||Standard Deviation|Mean
2591449|NCT02271854|Secondary|Sum of Pain Intensity Differences Over 48 Hours After Initiating Treatment (SPID 48), Derived From POW.|"Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) (POW) was a secondary outcome.~Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) for the modified ITT population. SPID 48 derived from Pain on Walking (POW) scores assessed over 48 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 48 was computed using the trapezoidal rule, i.e. Σ [T(i) - T(i-1)] x [((PID)(i-1) + PID(i))/2] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i."|48 hours||||units on a scale (NRS)||Standard Deviation|Mean
2591450|NCT02271854|Primary|Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW.|The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the modified ITT population. SPID 24 derived from Pain on Walking (POW) scores assessed over 24 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ [T(i) - T(i-1)] x [((PID)(i-1) + PID(i))/2] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i.|24 hours||||units on a scale (NRS)||Standard Deviation|Mean
2591451|NCT02271698|Other Pre-specified|Change in Interleukin 6 and 10 Levels|Interleukin levels and the ratio will assess pro and anti inflammatory processes in the patients|Sample immediately prior to incision and at 10-14, 22-26 and 33-39hours after surgery.|||||||
2591452|NCT02271698|Other Pre-specified|Change in Macrophage Proliferation|Macrophage totals and differentiation will be assessed within patients and between groups.|Samples will be taken immediately pre incision and will be repeated at 33-39hours|||||||
2591453|NCT02271698|Secondary|Change in Functional Status as Measured by Brief Pain Inventory Questionnaire|Brief pain inventory questionnaire will be administered generating a score (0-70). Higher scores reflect higher perceived pain interference.|Baseline at Enrollment, 3 and 6 months after surgery|Participants who completed questionnaire|||units on a scale||Inter-Quartile Range|Median
2591454|NCT02271698|Secondary|Change in Chronic Pain as Measured by Brief Pain Inventory Questionnaire|Brief pain inventory questionnaire will be administered generating a score (0-40). Higher scores reflect higher perceived pain.|Baseline at enrollment, 3 months and 6 months after surgery|Participants who completed questionnaire|||units on a scale||Inter-Quartile Range|Median
2591455|NCT02271698|Secondary|Change in Functional Status as Measured by Western Ontario and McMaster Universities Osteoarthritis Index|The Western Ontario and McMaster Universities Osteoarthritis Index measures 17 items for functional limitation (score range 0-68). Higher score = higher difficulty with the task.|30 days, 3 and 6 months following surgery|Participants who completed questionnaire|||units on a scale||Inter-Quartile Range|Median
2591456|NCT02271698|Primary|Change in Opioid Consumption|mg of morphine equivalents|6, 12, 18, 24, 36 hours after surgery|Participants who completed pain score at specified time-points.|||mg of morphine equivalents||Standard Deviation|Mean
2591457|NCT02271698|Primary|Change in Visual Analogue Pain Score|"Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where 0 represents no pain and 10 represents worst pain ever."|6, 12, 18, 24, 36 hours after surgery|Participants who completed pain score at specified time-points.|||units on a scale||Standard Deviation|Mean
2591458|NCT02271529|Primary|Mean Percent Change in Stent Length Upon Deployment||Immediately following completion of the stent placement procedure|There were 63 implanted stents, an assessment of stent length change was not available for 2 stents.|||percentage of change in stent length|Participants|Standard Deviation|Mean
2593567|NCT02244619|Other Pre-specified|Time to First Ambulation - 10 Feet||During post-op period up to 24 hours after surgery||||Hours||Inter-Quartile Range|Median
2591462|NCT02271477|Primary|Rate of Arterial Hypotension|To compare rates of arterial hypotension (previously define by international standard) after spinal anesthesia in patients who have undergone volemic optimization according to Trans-thoracic Echocardiography with patients who have been treated according to the current standard on the intention to treat population.|30 minute after spinal anesthesia|Rate of arterial hypotension after standardized spinal anesthesia|||percentage of participants|||Number
2591463|NCT02271451|Primary|Longitudinal DTI Changes|measured white matter changes, specifically AD, MD, and RD|2 years|Changes seen on DTI imaging|||voxels||Standard Deviation|Mean
2591464|NCT02271425|Primary|Pharmacokinetics (PK): Dose Normalized Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib||Day 1:Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.25, 4.5, 5, 5.5, 6, 6.5, 8, 10, 12, Day 2; 24, 36 Day 3; 48 Day 4; 72 Day 5; 96 Day 6; 120 Day 7; 144 and Day 8; 168 hours post-dose|All participants who received at least one dose of study drug and had evaluable PK data|||nanogramxhour/milliliter/mg (ngxh/ml/mg)||Geometric Coefficient of Variation|Geometric Mean
2591465|NCT02271386|Secondary|Implementation Outcome: Number of Clinicians Who Participated in All Intervention Components and Attested to Fulfilling MOC Requirements|We calculated the proportion of clinicians in the intervention group who completed all components of the intervention and attested to fulfilling MOC requirements.|Intervention Period (8 months)|This outcome was only assessed for intervention clinicians.|||Participants|||Count of Participants
2591466|NCT02271386|Secondary|Implementation Outcome: Number of Clinicians Who Participated in at Least One Performance Feedback Call|We calculated the proportion of clinicians in the intervention group who participated in at least one of the four performance feedback calls that were held during the study period.|Intervention Period (8 months)|This outcome was only assessed for intervention clinicians.|||Participants|||Count of Participants
2591467|NCT02271386|Secondary|Implementation Outcome: Number of Clinicians Who Used the Collaborative Consultation Component|We calculated the proportion of clinicians in the intervention group that posted in the online networking site which was used to facilitate collaborative consultation.|Intervention Period (8 months)|This outcome was only assessed for intervention clinicians.|||Participants|||Count of Participants
2591468|NCT02271386|Secondary|Implementation Outcome: Number of Clinicians Who Completed All 3 Educational Presentations|We assessed the proportion of clinicians randomized to the intervention group that completed all 3 educational presentations.|Intervention Period (8 months)|This outcome was only assessed for intervention clinicians.|||Participants|||Count of Participants
2591469|NCT02271386|Secondary|Number of Patients Whose Teacher Rating Scale Was Returned- by Feedback Call Participation|We calculated the percent of patient charts with evidence that a teacher rating scale was received by the clinician/practice during the intervention period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.|Intervention Period (8 months)|This outcome was only assessed for patients of clinicians in the intervention group, and compared patients of clinicians who did and did not participate in at least one performance feedback call. The feedback call group included 115 patients in the baseline and 112 in the intervention period. The non-feedback call group included 85 and 90.|||Participants|||Count of Participants
2591470|NCT02271386|Secondary|Number of Patients Who Were Sent the Teacher Rating Scale- by Feedback Call Participation|We calculated the percent of patient charts with evidence that a teacher rating scale was sent out during the intervention period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.|Intervention Period (8 months)|This outcome was only assessed for patients of clinicians in the intervention group, and compared patients of clinicians who did and did not participate in at least one performance feedback call. The feedback call group included 115 patients in the baseline and 112 in the intervention period. The non-feedback call group included 85 and 90.|||Participants|||Count of Participants
2591471|NCT02271386|Secondary|Number of Patients Whose Parent Rating Scale Was Returned- by Feedback Call Participation|We calculated the percent of patient charts with evidence that a parent rating scale was received by the clinician/practice during the intervention period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.|Intervention Period (8 months)|This outcome was only assessed for patients of clinicians in the intervention group, and compared patients of clinicians who did and did not participate in at least one performance feedback call. The feedback call group included 115 patients in the baseline and 112 in the intervention period. The non-feedback call group included 85 and 90.|||Participants|||Count of Participants
2591472|NCT02271386|Secondary|Number of Patients Who Were Sent the Parent Rating Scale- by Feedback Call Participation|We calculated the percent of patient charts with evidence that a parent rating scale was sent out during the intervention period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.|Intervention Period (8 months)|This outcome was only assessed for patients of clinicians in the intervention group, and compared patients of clinicians who did and did not participate in at least one performance feedback call. The feedback call group included 115 patients in the baseline and 112 in the intervention period. The non-feedback call group included 85 and 90.|||Participants|||Count of Participants
2591473|NCT02271386|Secondary|Number of Patients Whose Teacher Rating Scale Was Returned- by Feedback Call Participation|We calculated the percent of patient charts with evidence that a teacher rating scale was received by the clinician/practice during the baseline period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.|Baseline Period (8 months)|This outcome was only assessed for patients of clinicians in the intervention group, and compared patients of clinicians who did and did not participate in at least one performance feedback call. The feedback call group included 115 patients in the baseline and 112 in the intervention period. The non-feedback call group included 85 and 90.|||Participants|||Count of Participants
2591529|NCT02269943|Secondary|Terminal Half-Life (t1/2) of CC-486|Terminal phase half-life in plasma, calculated as [(ln 2)/λz]. t1/2 was only calculated when a reliable estimate for λz could be obtained.|Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).|The PK population includes participants with evaluable CC-486 plasma PK profiles.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2591474|NCT02271386|Secondary|Number of Patients Who Were Sent the Teacher Rating Scale- by Feedback Call Participation|We calculated the percent of patient charts with evidence that a teacher rating scale was sent out during the baseline period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.|Baseline Period (8 months)|This outcome was only assessed for patients of clinicians in the intervention group, and compared patients of clinicians who did and did not participate in at least one performance feedback call. The feedback call group included 115 patients in the baseline and 112 in the intervention period. The non-feedback call group included 85 and 90.|||Participants|||Count of Participants
2591475|NCT02271386|Secondary|Number of Patients Whose Parent Rating Scale Was Returned- by Feedback Call Participation|We calculated the percent of patient charts with evidence that a parent rating scale was received by the clinician/practice during the baseline period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.|Baseline Period (8 months)|This outcome was only assessed for patients of clinicians in the intervention group, and compared patients of clinicians who did and did not participate in at least one performance feedback call. The feedback call group included 115 patients in the baseline and 112 in the intervention period. The non-feedback call group included 85 and 90.|||Participants|||Count of Participants
2591476|NCT02271386|Secondary|Number of Patients Who Were Sent the Parent Rating Scale- by Feedback Call Participation|We calculated the percent of patient charts with evidence that a parent rating scale was sent out during the baseline period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.|Baseline Period (8 months)|This outcome was only assessed for patients of clinicians in the intervention group, and compared patients of clinicians who did and did not participate in at least one performance feedback call. The feedback call group included 115 patients in the baseline and 112 in the intervention period. The non-feedback call group included 85 and 90.|||Participants|||Count of Participants
2591477|NCT02271386|Secondary|Number of Patients Whose Teacher Rating Scale Was Returned- by MOC Status|We calculated the percent of patient charts with evidence that a teacher rating scale was received by the clinician/practice during the intervention period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.|Intervention Period (8 months)|This outcome was only assessed for patients of clinicians in the intervention group, and compared patients of clinicians who did and did not fulfill all requirements to receive Maintenance of Certification (MOC) credit. The MOC group included 76 patients in the baseline and 73 in the intervention period. The non-MOC group included 124 and 129.|||Participants|||Count of Participants
2591478|NCT02271386|Secondary|Number of Patients Who Were Sent the Teacher Rating Scale- by MOC Status|We calculated the percent of patient charts with evidence that a teacher rating scale was sent out during the intervention period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.|Intervention Period (8 months)|This outcome was only assessed for patients of clinicians in the intervention group, and compared patients of clinicians who did and did not fulfill all requirements to receive Maintenance of Certification (MOC) credit. The MOC group included 76 patients in the baseline and 73 in the intervention period. The non-MOC group included 124 and 129.|||Participants|||Count of Participants
2591479|NCT02271386|Secondary|Number of Patients Whose Parent Rating Scale Was Returned- by MOC Status|We calculated the percent of patient charts with evidence that a parent rating scale was received by the clinician/practice during the intervention period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.|Intervention Period (8 months)|This outcome was only assessed for patients of clinicians in the intervention group, and compared patients of clinicians who did and did not fulfill all requirements to receive Maintenance of Certification (MOC) credit. The MOC group included 76 patients in the baseline and 73 in the intervention period. The non-MOC group included 124 and 129.|||Participants|||Count of Participants
2591480|NCT02271386|Secondary|Number of Patients Who Were Sent the Parent Rating Scale- by MOC Status|We calculated the percent of patient charts with evidence that a parent rating scale was sent out during the intervention period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.|Intervention Period (8 months)|This outcome was only assessed for patients of clinicians in the intervention group, and compared patients of clinicians who did and did not fulfill all requirements to receive Maintenance of Certification (MOC) credit. The MOC group included 76 patients in the baseline and 73 in the intervention period. The non-MOC group included 124 and 129.|||Participants|||Count of Participants
2591481|NCT02271386|Secondary|Number of Patients Whose Teacher Rating Scale Was Returned- by MOC Status|We calculated the percent of patient charts with evidence that a teacher rating scale was received by the clinician/practice during the baseline period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.|Baseline Period (8 months)|This outcome was only assessed for patients of clinicians in the intervention group, and compared patients of clinicians who did and did not fulfill all requirements to receive Maintenance of Certification (MOC) credit. The MOC group included 76 patients in the baseline and 73 in the intervention period. The non-MOC group included 124 and 129.|||Participants|||Count of Participants
2591482|NCT02271386|Secondary|Number of Patients Who Were Sent the Teacher Rating Scale- by MOC Status|We calculated the percent of patient charts with evidence that a teacher rating scale was sent out during the baseline period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.|Baseline Period (8 months)|This outcome was only assessed for patients of clinicians in the intervention group, and compared patients of clinicians who did and did not fulfill all requirements to receive Maintenance of Certification (MOC) credit. The MOC group included 76 patients in the baseline and 73 in the intervention period. The non-MOC group included 124 and 129.|||Participants|||Count of Participants
2591530|NCT02269943|Secondary|Time to Reach Maximum Concentration (Tmax) Of CC-486|Time to Cmax, obtained directly from the observed concentration versus time data.|Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).|The PK population includes participants with evaluable CC-486 plasma PK profiles.|||Hours||Full Range|Median
2593568|NCT02244619|Other Pre-specified|Post-operative Nausea and Vomiting||During post-op period up to 24 hrs after surgery||||Participants|||Count of Participants
2591483|NCT02271386|Secondary|Number of Patients Whose Parent Rating Scale Was Returned- by MOC Status|We calculated the percent of patient charts with evidence that a parent rating scale was received by the clinician/practice during the baseline period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.|Baseline Period (8 months)|This outcome was only assessed for patients of clinicians in the intervention group, and compared patients of clinicians who did and did not fulfill all requirements to receive Maintenance of Certification (MOC) credit. The MOC group included 76 patients in the baseline and 73 in the intervention period. The non-MOC group included 124 and 129.|||Participants|||Count of Participants
2591484|NCT02271386|Secondary|Number of Patients Who Were Sent the Parent Rating Scale - by MOC Status|We calculated the percent of patient charts with evidence that a parent rating scale was sent out during the baseline period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.|Baseline Period (8 months)|This outcome was only assessed for patients of clinicians in the intervention group, and compared patients of clinicians who did and did not fulfill all requirements to receive Maintenance of Certification (MOC) credit. The MOC group included 76 patients in the baseline and 73 in the intervention period. The non-MOC group included 124 and 129.|||Participants|||Count of Participants
2591485|NCT02271386|Primary|Number of Patients Whose Teacher Rating Scale Was Returned|This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was received by the clinician during the intervention interval|Intervention Period (8 months)|We reviewed charts for a total of 402 patients of intervention clinicians (200 who had an office visit in the 8-month baseline period and 202 who had an office visit in the 8-month intervention period). We reviewed charts for a total of 388 patients of control clinicians (191 in the baseline period and 197 in the control period).|||Participants|||Count of Participants
2591486|NCT02271386|Primary|Number of Patients Who Were Sent the Teacher Rating Scale|This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was sent out during the intervention interval|Intervention Period (8 months)|We reviewed charts for a total of 402 patients of intervention clinicians (200 who had an office visit in the 8-month baseline period and 202 who had an office visit in the 8-month intervention period). We reviewed charts for a total of 388 patients of control clinicians (191 in the baseline period and 197 in the control period).|||Participants|||Count of Participants
2591487|NCT02271386|Primary|Number of Patients Whose Parent Rating Scale Was Returned|This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was received by the clinician during the intervention interval|Intervention Period (8 months)|We reviewed charts for a total of 402 patients of intervention clinicians (200 who had an office visit in the 8-month baseline period and 202 who had an office visit in the 8-month intervention period). We reviewed charts for a total of 388 patients of control clinicians (191 in the baseline period and 197 in the control period).|||Participants|||Count of Participants
2591488|NCT02271386|Primary|Number of Patients Who Were Sent the Parents Rating Scale|This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was sent out during the intervention interval|Intervention Period (8 months)|We reviewed charts for a total of 402 patients of intervention clinicians (200 who had an office visit in the 8-month baseline period and 202 who had an office visit in the 8-month intervention period). We reviewed charts for a total of 388 patients of control clinicians (191 in the baseline period and 197 in the control period).|||Participants|||Count of Participants
2591489|NCT02271386|Primary|Number of Patients Whose Teacher Rating Scale Was Returned|This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was received by the clinician during the baseline interval|Baseline Period (8 months)|We reviewed charts for a total of 402 patients of intervention clinicians (200 who had an office visit in the 8-month baseline period and 202 who had an office visit in the 8-month intervention period). We reviewed charts for a total of 388 patients of control clinicians (191 in the baseline period and 197 in the control period).|||Participants|||Count of Participants
2591490|NCT02271386|Primary|Number of Patients Who Were Sent the Teacher Rating Scale|This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was sent out during the baseline interval|Baseline Period (8 months)|We reviewed charts for a total of 402 patients of intervention clinicians (200 who had an office visit in the 8-month baseline period and 202 who had an office visit in the 8-month intervention period). We reviewed charts for a total of 388 patients of control clinicians (191 in the baseline period and 197 in the control period).|||Participants|||Count of Participants
2591491|NCT02271386|Primary|Number of Patients Whose Parent Rating Scale Was Returned|This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was received by the clinician during the baseline interval|Baseline Period (8 months)|We reviewed charts for a total of 402 patients of intervention clinicians (200 who had an office visit in the 8-month baseline period and 202 who had an office visit in the 8-month intervention period). We reviewed charts for a total of 388 patients of control clinicians (191 in the baseline period and 197 in the control period).|||Participants|||Count of Participants
2591492|NCT02271386|Primary|Number of Patients Who Were Sent the Parents Rating Scale|This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was sent out during the baseline interval|Baseline Period (8 months)|We reviewed charts for a total of 402 patients of intervention clinicians (200 who had an office visit in the 8-month baseline period and 202 who had an office visit in the 8-month intervention period). We reviewed charts for a total of 388 patients of control clinicians (191 in the baseline period and 197 in the control period).|||Participants|||Count of Participants
2591964|NCT02263326|Secondary|Change in Total Cholesterol From Baseline to Week 48|Change in Total Cholesterol between arms will be presented in the attached statistical analysis table|Baseline and 48 weeks|Population with total cholesterol data available at baseline and week 48|||mg/dL||Inter-Quartile Range|Median
2591493|NCT02271217|Secondary|Change From Baseline on the Walking Impact Scale (Walk-12) at Week 12 (Key Secondary)|"The Walk-12 is a 12-question questionnaire that asks subjects to rate limitations of their mobility during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). For each visit, the Walk-12 score will be calculated by summing the 12 components and transforming into a scale with a range of 0 to 100. A higher score indicates a greater degree of limitation in walking. A negative change indicates an improvement in walking. 0 = no limitation in mobility to 100 extreme limitation in mobility.~Walk-12 Score = 100 * [(Mean of the 12 items) - 1]/(5-1)"|Baseline, week 12|Includes all randomized subjects who took at least one dose of double-blind study treatment, had at least one 2MinWT assessment during the placebo run-in period, and at least one 2MinWT assessment during the double-blind treatment period.|||units on a scale||Standard Deviation|Mean
2591494|NCT02271217|Primary|Proportion of Subjects Who Show at Least a 20% Improvement on the Two Minute Walk Test (2MinWT) at Week 12|"The 2MinWT measures the distance a subject can walk in 2 minutes. Participants showing at Least a 20% Improvement on the 2MinWT at 12-weeks are considered Responders."|Week 12|Includes all randomized subjects who took at least one dose of double-blind study treatment, had at least one 2MinWT assessment during the placebo run-in period, and at least one 2MinWT assessment during the double-blind treatment period.|||participants|||Number
2591495|NCT02270983|Secondary|Change From Baseline in 8-Week Abdominal Bloating|Abdominal bloating was collected daily via IVRS calls and measured using an 11-point numerical rating scale, where 0 represents no abdominal bloating and 10 represents very severe abdominal bloating.|Baseline (Week 0) to Week 8|252 participants received at least one dose of study drug, comprising the ITT study population.|||Units on a scale||Standard Error|Least Squares Mean
2591496|NCT02270983|Secondary|Change From Baseline in 8-Week Straining|"Straining was measured on a 5-point ordinal scale where a value of 1 is not at all and a value of 5 is an extreme amount."|Baseline (Week 0) to Week 8|Of the 252 participants in the ITT population, 200 participants had 8-week straining data collected|||Units on a scale||Standard Error|Least Squares Mean
2591497|NCT02270983|Secondary|Change From Baseline in 8-Week Stool Consistency|"Stool Consistency was assessed using the 7-Point Bristol Stool Form Scale:~= separate hard lumps like nuts (difficult to pass)~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges (passed easily)~= fluffy pieces with ragged edges, a mushy~= watery, no solid pieces (entirely liquid)"|Baseline (Week 0) to Week 8|Of the 252 participants in the ITT population, 200 participants had Stool Consistency data collected|||Units on a scale||Standard Error|Least Squares Mean
2591498|NCT02270983|Secondary|Percentage of Participants Meeting 6/8 Week Spontaneous Bowel Movement (SBM) 3 + 1 Responder Criteria|A 6/8 Week SBM 3 + 1 responder was a participant who met the weekly SBM 3 + 1 responder criteria for at least 6 out of the 8 weeks of the Treatment Period. For each week in the Treatment Period, a weekly SBM 3 + 1 responder was a patient who had an SBM weekly rate ≥ 3 and an increase ≥ 1 in the SBM weekly rate from baseline for that week.|8-week treatment period|252 participants received at least one dose of study drug, comprising the ITT study population.|||Percentage of Responders|||Number
2591499|NCT02270983|Secondary|Time to First SBM After the First Dose of Investigational Product|The median time to the first SBM after the first dose of investigational product|Baseline (Day 0) up to 8 weeks|252 participants received at least one dose of study drug, comprising the ITT study population.|||hours||95% Confidence Interval|Median
2591500|NCT02270983|Primary|Change From Baseline in 8-Week SBM Frequency Rate (SBMs/Week)|Change from baseline in 8-Week SBM frequency rate (SBMs/week) during the Treatment Period.|Baseline (Week 0) to Week 8|252 participants received at least one dose of study drug, comprising the ITT study population.|||Number of SBMs per week||Standard Error|Least Squares Mean
2591501|NCT02270944|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|Safety was assessed as the number of subjects who reported SAEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.|From Day 1 to Day 181 (end of the study)|Analyses were evaluated on the Unsolicited AEs Safety Set (i.e. all subjects in the exposed set who provided information about post vaccination unsolicited AEs). There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.|||Subjects|||Number
2591502|NCT02270944|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Safety was assessed as the number of subjects who reported unsolicited AEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.|From Day 1 to Day 181 (end of the study)|Analyses were evaluated on the Unsolicited AEs Safety Set (i.e. all subjects in the exposed set who provided information about post vaccination unsolicited AEs). There were 3 subjects in the Liquid GBS trivalent vaccine group who were treated but for whom no safety data were available.|||Subjects|||Number
2591503|NCT02270944|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)|Safety was assessed as the number of subjects who reported solicited local and solicited systemic AEs following a single injection with either liquid or lyophilized GBS trivalent vaccine formulations.|From 6 hours through Day 7 post-vaccination|Analyses were evaluated on the Solicited Safety Set (i.e. all subjects in the exposed set with data on post vaccination local or systemic AEs or other signs of reactogenicity). For 3 treated subjects in the Liquid GBS trivalent vaccine group, no safety data were available and for 4 subjects from both groups, no solicited safety data were reported.|||Participants|||Count of Participants
2591504|NCT02270944|Primary|Concentration of Serotype Ib GBS IgG Levels in Healthy Non-pregnant Women|To evaluate serotype-specific Ib GBS serum IgG antibody levels (anti-Ib) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Geometric mean concentrations (GMCs) were measured and expressed in micrograms per milliliter (μg/mL). As the singleton ELISA was no longer in use at the time of serotype Ib testing, results were obtained using multiplex immunoassay.|At Day 31 after a single vaccination|All subjects in the Full Analysis Set immunogenicity population who received the study vaccine, have no major protocol deviation or other reasons to be excluded as defined prior to unblinding & provided evaluable serum samples both before vaccination and at Day 31 in the protocol required windows.|||µg/mL||95% Confidence Interval|Geometric Mean
2591965|NCT02263326|Secondary|Change in CD4 Count From Baseline to Week 48|Change in CD4 count between arms will be presented in the attached statistical analysis table|Baseline and 48 weeks|Population with CD4 count data available at baseline and week 48|||cells/mm^3||Inter-Quartile Range|Median
2591505|NCT02270944|Primary|Concentration of Serotype III GBS IgG Levels in Healthy Non-pregnant Women|To evaluate serotype-specific III GBS serum IgG antibody levels (anti-III) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).|At Day 31 after a single vaccination|All subjects in the Full Analysis Set immunogenicity population who received the study vaccine, have no major protocol deviation or other reasons to be excluded as defined prior to unblinding & provided evaluable serum samples both before vaccination and at Day 31 in the protocol required windows.|||µg/mL||95% Confidence Interval|Geometric Mean
2591506|NCT02270944|Primary|Concentration of Serotype Ia GBS IgG Levels in Healthy Non-pregnant Women|To evaluate serotype-specific Ia GBS serum IgG antibody levels (anti-Ia) in healthy non-pregnant women when administered with the liquid GBS trivalent vaccine formulation or the lyophilized GBS trivalent vaccine formulation. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).|At Day 31 after a single vaccination|All subjects in the Full Analysis Set immunogenicity population who received the study vaccine, have no major protocol deviation or other reasons to be excluded as defined prior to unblinding & provided evaluable serum samples both before vaccination and at Day 31 in the protocol required windows.|||µg/mL||95% Confidence Interval|Geometric Mean
2591507|NCT02270684|Primary|Knee Osteoarthritis Outcome Score (KOOS)|The KOOS is a validated tool to measure pain and quality of life in patients after TKA|Baseline, 4, 10, 24 weeks|Due to early termination, no evaluable data was collected||||||
2591508|NCT02270671|Secondary|Depression Symptoms at 4-week Post-intervention and 12-week Follow-up|The Revised Child Anxiety and Depression Scale - Major Depressive Disorder (RCADS-MDD). The major depressive disorder subscale of the RCADS (Chorpita, Yim, Moffitt, Umemoto, & Francis, 2000) is a 10-item subscale exploring symptoms of MDD as characterised by the DSM-IV, with on a 4-point Likert scale ranging from 0 = never to 3 = always. Scores range from 0 to 30. A score of 11 or higher has been shown to optimise sensitivity and specificity for the prediction of MDD (Ebesutani et al., 2012).|Post-intervention (week 4), and 12-week follow-up||||units on a scale||Standard Deviation|Mean
2591509|NCT02270671|Secondary|Anxiety Related Disorders at 4-week Post-intervention and 12-week Follow-up|The Screen for Child Anxiety Related Emotional Disorders (SCARED)(Birmaher et al., 1997) is a 41-item measure which has five subscales. Responses use a 3-point Likert scale, 0 = not true, or hardly ever true to 2 = very true or often true. The subscales are: Generalized Anxiety Disorder (GAD) (9 items, range 0-18); Panic Disorder (13 items, 0-26); Separation Anxiety Disorder (8 items, 0-16); and Social Phobia (7 items, 0-14), and School Avoidance (4 items, 0-8). Subscales are summed to provide a total score (range 0-82; while scores over 25 may be indicative of an anxiety disorder).|Post-intervention (week 4), and 12-week follow-up||||units on a scale||Standard Deviation|Mean
2591510|NCT02270671|Secondary|Fear of Negative Evaluation at 4-week Post-Intervention and 12-week Follow-Up|A 12-item self-report questionnaire to measure fear of negative evaluation - Brief Fear of Negative Evaluation Questionnaire -II (BFNE-II; Carleton et al., 2007). The BFNE-R (Carleton, McCreary, Norton, & Asmundson, 2006) is a 12-item, revised version of the BFNE (Leary, 1983) used to elicit respondents' fear of negative evaluation. Responses are indicated using a 5-point Likert scale response format from 0 = not at all characteristics of me to 4 = entirely characteristic of me. Scores range from 0 to 48. Higher scores indicate higher fear of negative evaluation|Post-intervention (week 4), and 12-week follow-up||||units on a scale||Standard Deviation|Mean
2591511|NCT02270671|Primary|Social Phobia and Anxiety at 4-week Post-intervention and 12-week Follow-up|The Social Phobia and Anxiety Inventory for Children (SPAI-C)(Beidel et al., 1998, 2000) is a 26-item, self-report measure exploring anxiety in social situations. Responses are indicated using a 3-point Likert scale from 0 = never or hardly ever to 2 = most of the time or always with scores ranging from 0-52. Higher scores on the SPAI-C represent higher levels of social anxiety.|Post-intervention (week 4), and 12-week follow-up||||units on a scale||Standard Deviation|Mean
2591512|NCT02270671|Primary|Threat Bias Measurement at 4-week Post-intervention and 12-week Follow-up|The bias measurement protocol consists of 120 trials (80 angry-neutral and 40 neutral-neutral presentations). Angry face location, probe location, probe type and actor are all fully counterbalanced in presentation. The participant must perform with more than 70% accuracy on the first 10 trials.The threat bias measurement consisted of 120 trials of the dot-probe task, 80 of which contained angry-neutral face pairs and 40 of which contained neutral-neutral face pairs. The threat bias score equal the mean of neutral NT trials minus mean of threat NT trials. A threat bias scores >0 indicate a bias towards threat, whereas scores <0 mean that the participant is slower to respond to threatening stimuli than neutral stimuli. Reaction times were measured in milliseconds.|Post-intervention (week 4), and 12-week follow-up||||milliseconds||Standard Deviation|Mean
2591513|NCT02270645|Secondary|Number of Adverse Events Reported|Adverse events reported by participants|91 days||||Adverse Events|||Number
2591514|NCT02270645|Primary|Percentage of Lesions Cleared Histologically|Number of lesions cleared clinically and histologically. The lesion clearance was determined by measuring the size of lesion which also included a histological evaluation 4 weeks after the treatment.|91 days|"In the treatment arm, there were 6 patients with a total of 9 lesions. Some of these patients had multiple lesions treated.~In the control arm, there were 4 patients with a total of 5 lesions. Some of these patients had multiple lesions treated."|||Lesion|Lesion||Count of Units
2591515|NCT02270515|Primary|Estimated KDQOL-36 Scale Score Change for Each 6-month Period and 0-18 Months: Adjusted Random-intercept Models|Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.|Baseline (0) to 18 months|All records with data for the KDQOL scale score (dependent variable) and covariates were included in the analysis. Two participants were excluded due to missing data for covariates: dialysis vintage and PCP at baseline. The previous table (adjusted means) shows the number of records with complete data for each visit.|||units on a scale||Standard Error|Mean
2591966|NCT02263326|Secondary|Proportion of Participants With Virologic Success|Proportion of participants with virologic success (<50 copies/mL) based on FDA snapshot definition|48 weeks||||proportion of participants|||Number
2591516|NCT02270515|Primary|Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Adjusted|"Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.~Adjusted means are from random-intercept linear mixed models with an AR(1) covariance pattern in the residual, adjusted for baseline age, sex, race (AA, all other), interview language, dialysis vintage (months), site, education (not HS grad, HS grad), marital status (married or living with partner, other), self-reported diabetes at baseline, PCP at baseline, urea reduction ratio (URR), hemoglobin (g/dL), and albumin (g/dL). The 3 lab values are time-varying covariates."|Baseline (0) to 18 months|Ns shown in the table are the number of records at each visit with data for the KDQOL scale score and all covariates. All available records were used to estimate the adjusted means. For all scales, N=173 participants; 2 were excluded due to missing data for covariates: dialysis vintage and PCP at baseline.|||units on a scale||Standard Error|Mean
2591517|NCT02270515|Primary|Kidney Disease Quality of Life (KDQOL-36) Mean Scale Scores at Baseline, 6, 12 and 18 Months: Unadjusted|Quality of life (QOL) was measured using the Kidney Disease Quality of Life-36 (KDQOL-36) survey, a kidney-disease-specific quality of life instrument that assesses five domains: general physical health, mental health, disease burden, disease symptoms, and disease effects. For all KDQOL scales, a higher score indicates better quality of life. All domain scales can range from 0-100.|Baseline (0) to 18 months|Overall number of participants analyzed are the number who completed the KDQOL at each visit. They differ slightly from the number of participants in the flow chart due to missing KDQOL data. Ns are slightly lower for some scale scores due to missing items (see below).|||units on a scale||Standard Deviation|Mean
2591518|NCT02270255|Secondary|Number of Patients With Serious Adverse Reactions From Superior Hypogastric Nerve Block|Number of patients with Grade C/D/E/F adverse events (Society of Interventional Radiology (SIR) Classification). Per Society of Interventional Radiology (SIR) Classification: Grade C, require therapy, brief hospitalization (<48 hours); Grade D, require major therapy, unplanned increased level of care, prolonged hospitalization (>48 hours); Grade E, permanent adverse sequelae; Grade F, death.|10 days||||Participants|||Count of Participants
2591519|NCT02270255|Primary|mg Equivalent Morphine Used Until Discharge From Recovery Room to Control Pain Level Below 4/10 (VAS)|mg equivalent morphine used until discharge from recovery room to maintain pain level below 4/10 (visual analog scale 0/10=no pain to 10/10=worse pain the patient could imagine)|6 hrs (from time of end of UFE to time of discharge from recovery room)||||mg||Standard Deviation|Mean
2591520|NCT02270060|Secondary|Change (Post - Pre) From Baseline in Numeric Pain Rating (NPR)|Numeric pain rating between 0-10 before and after admission to acute care clinic. The minimum score is 0. The maximum score is 10. Higher scores represent worse pain.|From time of admission into acute care clinic to time of discharge, up to 8 hours.|All participants who participated in the music therapy intervention.|||score on a scale||Standard Deviation|Mean
2591521|NCT02270060|Secondary|Amount of Hydromorphone|Amount of Hydromorphone received in acute care clinic following intervention|From time of admission into acute care clinic to time of discharge, up to 8 hours.|All participants who participated in the music therapy intervention and received hydromorphone.|||milligrams||Standard Deviation|Mean
2591522|NCT02270060|Secondary|Length of Stay in Minutes|Length of stay (in minutes) in acute care clinic|From time of admission into acute care clinic to time of discharge, up to 8 hours.|All participants who participated in the music therapy intervention.|||minutes||Standard Deviation|Mean
2591523|NCT02270060|Secondary|Change (Post - Pre) From Baseline in Tursky Scale of Memorial Pain Assessment Card|Pain adjectives scale. The minimum score is 1. The maximum score is 7. Higher scores represent worse pain.|Baseline and at end of 20-minute intervention, up to 120 minutes following randomization|All participants who participated in the music therapy intervention.|||score on a scale||Standard Deviation|Mean
2591524|NCT02270060|Secondary|Change (Post- Pre) From Baseline in Visual Analog Scale of Mood (VASMOOD) of Memorial Pain Assessment Card|Visual analog scale of mood. The minimum score is 0. The maximum score is 10. Higher scores represent better mood.|Baseline and at end of 20-minute intervention, up to 120 minutes following randomization|All participants who participated in the music therapy intervention.|||score on a scale||Standard Deviation|Mean
2591525|NCT02270060|Secondary|Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Relief (VASPR) of Memorial Pain Assessment Card|Visual analog scale of Pain Relief. The minimum score is 0. The maximum score is 10. Higher scores represent greater pain relief.|Baseline and at end of 20-minute intervention, up to 120 minutes following randomization|All participants who participated in the music therapy intervention.|||score on a scale||Standard Deviation|Mean
2591526|NCT02270060|Primary|Change (Post - Pre) From Baseline in Visual Analog Scale of Pain Intensity (VASPI) of Memorial Pain Assessment Card|Visual analog scale of pain intensity. The minimum score is 0. The maximum score is 10. Higher scores represent worse pain intensity.|Baseline and at end of 20-minute intervention, up to 120 minutes following randomization|All participants who participated in the music therapy intervention.|||score on a scale||Standard Deviation|Mean
2591527|NCT02269943|Secondary|Apparent Volume of Distribution (Vz/F) Of CC-486|Apparent volume of distribution, calculated as [(CL/F)/λz].|Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).|The PK population includes participants with evaluable CC-486 plasma PK profiles.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2591528|NCT02269943|Secondary|Apparent Total Clearance (CL/F) Of CC-486|Apparent volume of distribution, calculated as [(CL/F)/λz].|Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).|The PK population includes participants with evaluable CC-486 plasma PK profiles.|||Liters/hour||Geometric Coefficient of Variation|Geometric Mean
2591643|NCT02268396|Secondary|Percentage of Devices Where the Dose Indicator Actuation Count is >20 Less Than the Subject-reported Actuation Count (Undercount)|Percentage of devices where the dose indicator actuation count is >20 less than the subject-reported actuation count (undercount)|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population|||Percentage|||Number
2591531|NCT02269943|Secondary|Maximum Observed Concentration (Cmax) Of CC-486|Maximum observed plasma concentration, obtained directly from the observed concentration versus time data.|Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).|The PK population includes participants with evaluable CC-486 plasma PK profiles|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2591532|NCT02269943|Secondary|Area Under the Plasma Concentration -Time Curve From 0 Extrapolated to Infinity (AUC-inf, AUC0-∞) Of CC-486|Area under the plasma concentration-time curve from Time 0 extrapolated to infinity, calculated as [AUCt + Ct/ λz]. Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz. If AUC %Extrap was ≥25%, AUC inf was not reported.|Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).|The PK population includes participants with evaluable CC-486 plasma PK profiles.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2591533|NCT02269943|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration Of CC-486 (AUC-t)|Area under the plasma concentration-time curve from Time 0 to the time of the last quantifiable concentration, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|Blood samples for oral azacitidine PK assessment were collected prior to each dose (pre-dose) and over the 8-hour period following each dose (0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose or similar schedule).|The PK population includes participants with evaluable CC-486 plasma PK profiles.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2591534|NCT02269943|Secondary|Number of Participants With Treatment Emergent Adverse Events|Treatment-emergent adverse events (TEAEs) were defined as any adverse event (AE) or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the investigational product (IP) through 28 days after the last dose of IP. In addition, any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and based on the following scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.|From date of first dose of study treatment to 28 days after last dose of study treatment; up to final data cut-off date of 08 August 2017; median treatment duration was 257 days for CC-486 200 mg and 114.5 days for CC-486 300 mg|The Safety Population included all participants who received at least 1 dose of IP.|||Participants|||Count of Participants
2591535|NCT02269943|Secondary|Percentage of Participants With Stable Disease for ≥ 16 Weeks From the Date of the First Treatment, or CR or PR According to RECIST 1.1 Criteria and Based on an Independent Radiology Assessment|Disease Control Rate (DCR) was defined as the percentage of participants with a CR, PR, confirmed ≥ 4 weeks after the criteria for response were first met, or stable disease for ≥ 16 weeks from the first treatment, based on independent radiology assessment using RECIST 1.1 criteria. A complete response was defined as the disappearance of all target lesions and non-target lesions; a partial response is at least a 30% decrease from baseline in the sum of diameters of target lesions with no progression of non-target lesions and no new lesions or disappearance of target lesions with persistence of one or more non-target lesions from baseline. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease|Tumor response was assessed every 6 weeks for the first 3 evaluations then every 9 weeks until disease progression. As of the cut-off date of 08 August 2017 the median duration of treatment was 257 days for the 200 mg dose and 114.5 days for 300 mg dose|Efficacy Evaluable Population = enrolled participants who met eligibility criteria and either received 2 cycles of IP at any dose and discontinued treatment for progressive disease or received 4 cycles of IP and had at least 2 post-screening tumor exams.|||percentage of participants||90% Confidence Interval|Median
2591536|NCT02269943|Secondary|Kaplan Meier Estimate of Overall Survival|Overall survival was the time from the first dose of study drug to patient death from any cause. Participants who did not die were censored at the last known time the patient was alive date or the clinical data cutoff date, whichever was earlier.|From Day 1 of study treatment to the first date of progressive disease or death; up to data cut-off date of 08 August 2017; overall median follow-up time for censored participants was 20.4 months|The Efficacy Evaluable Population included all enrolled participants who met eligibility criteria and either received 2 cycles of CC-486 at any dose and discontinued treatment for progressive disease or received 4 cycles of CC-486 and had a baseline and at least 2 post-screening tumor assessments.|||months||90% Confidence Interval|Median
2591537|NCT02269943|Primary|Kaplan Meier Estimate of Progression-Free Survival (PFS) Based on an Independent Radiology Assessment According to RECIST 1.1 Criteria|PFS was defined as the time from the date of start of the study treatment to the date of disease progression or death (any cause) on or prior to the data cut-off date for the statistical analysis, whichever occurred earlier, based on an independent radiology assessment of response using RECIST v1.1 criteria. Progressive disease was defined as at least a 20% increase in the sum of diameters of target or non-target lesions from nadir or appearance of a new lesion.|From Day 1 of documented disease progression; up to data cut off date of 08 August 2017; median follow-up time for censored participants was 12.3 months|The Efficacy Evaluable Population included all enrolled participants who met eligibility criteria and either received 2 cycles of CC-486 at any dose and discontinued treatment for progressive disease or received 4 cycles of CC-486 and had a baseline and at least 2 post-screening tumor assessments.|||months||90% Confidence Interval|Median
2591549|NCT02269917|Secondary|Percentage of Participants With Virologic Response Based on HIV-1 RNA <20, <50, and <200 Copies/mL Threshold at Week 48 as Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm|Percentage of participants with virologic response based on HIV-1 RNA <20, <50, and <200 copies/mL threshold were analyzed at Week 48 using TLOVR algorithm approach. TLOVR was defined as sustained HIV-1 RNA <20/50/200 copies/mL.|Week 48|ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2591685|NCT02267603|Secondary|Duration of Response (DOR)|Survival curves for DOR will be estimated using the Kaplan-Meier method.|Time interval between the date of first response (CR/PR) and the date of progression, assessed up to 3 years|||||||
2591538|NCT02269943|Primary|Percentage of Participants Who Achieved a Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) Based on an Independent Radiology Assessment (IRA)|"Overall response rate was defined as the combined incidence of Complete Response (CR) or Partial Response (PR), confirmed no less than 4 weeks after the criteria for response were first met, based on independent radiology assessment according to RECIST 1.1 criteria.~Complete response was defined as the disappearance of all target lesions and non-target lesions; Partial response is at least a 30% decrease from baseline in the sum of diameters of target lesions with no progression of non-target lesions and no new lesions or disappearance of target lesions with persistence of one or more non-target lesions from baseline."|Tumor response was assessed every (Q) 6 weeks for the first 3 evaluations then Q 9 weeks until disease progression as of the cut-off date of 08 August 2017; the median duration of treatment was 257 days for the 200 mg dose and 114.5 days for 300 mg dose|The Efficacy Evaluable Population included all enrolled participants who met eligibility criteria and either received 2 cycles of CC-486 at any dose and discontinued treatment for progressive disease or received 4 cycles of CC-486 and had a baseline and at least 2 post-screening tumor assessments.|||percentage of participants||90% Confidence Interval|Number
2591539|NCT02269917|Secondary|Change From Baseline in Bone Mineral Density (BMD) T-Score at Weeks 24 and 48|Change from baseline in spine, hip, and femoral neck BMD T-Score was assessed at Week 24 and 48. T-score values >= -1.0 were considered normal, T-score values < -1.0 to -2.5 indicate osteopenia and T-score values < -2.5 indicate osteoporosis.|Baseline, Weeks 24 and 48|The bone investigation substudy (BIS) analysis set included all participants who were randomized and received at least 1 dose of study drug in the study, and had at least one postbaseline value for BMD data. Here ‘n’ specifies those participants who were analyzed for this endpoint at given time point.|||Units on a scale||Standard Error|Mean
2591540|NCT02269917|Secondary|Percent Change From Baseline in Spine and Hip Bone Mineral Density (BMD) at Weeks 24 and 48|Percent change from baseline in spine and hip BMD was assessed at Weeks 24 and 48.|Baseline, Weeks 24 and 48|The bone investigation substudy (BIS) analysis set included all participants who were randomized and received at least 1 dose of study drug in the study, and had at least one postbaseline value for bone mineral density (BMD) data. Here ‘n’ specifies participants who were analyzed for this endpoint at given time point.|||Percent change||Standard Error|Least Squares Mean
2591541|NCT02269917|Secondary|Percent Change From Baseline in 25-hydroxy Vitamin D at Weeks 24 and 48|Percent change from baseline in bone biomarker: 25-hydroxy vitamin D was assessed at Weeks 24 and 48.|Baseline, Weeks 24 and 48|The bone investigation substudy (BIS) analysis set included all participants who were randomized and received at least 1 dose of study drug in the study, and had at least one postbaseline value for biomarker data. Here ‘n’ specifies participants who were analyzed for this endpoint at given time point.|||Percent change||Standard Error|Mean
2591542|NCT02269917|Secondary|Percent Change From Baseline in Parathyroid Hormone (PTH) at Weeks 24 and 48|Percent change from baseline in bone biomarker: PTH was assessed at Weeks 24 and 48.|Baseline, Weeks 24 and 48|The bone investigation substudy (BIS) analysis set included all participants who were randomized and received at least 1 dose of study drug in the study, and had at least one postbaseline value for biomarker data. Here ‘n’ specifies participants who were analyzed for this endpoint at given time point.|||Percent change||Standard Error|Mean
2591543|NCT02269917|Secondary|Percent Change From Baseline in Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Collagen Type 1 Beta Carboxy Telopeptide (CTX) Levels at Weeks 24 and 48|Percent change from baseline in bone biomarkers: P1NP and CTX was assessed at Weeks 24 and 48.|Baseline, Weeks 24 and 48|The bone investigation substudy (BIS) analysis set included all participants who were randomized and received at least 1 dose of study drug in the study, and had at least one postbaseline value for biomarker data. Here ‘n’ specifies participants who were analyzed for this endpoint at given time point.|||Percent Change||Standard Error|Mean
2591544|NCT02269917|Secondary|Predose (Trough) Plasma Concentration (C0h) of Darunavir|Predose (trough) plasma concentration (C0h) of darunavir was determined. Pharmacokinetic (PK) data was only analyzed for participants in the D/C/F/TAF group as per planned analysis.|Predose at Weeks 2, 4, 8, 12, 24, 36, and 48|The PK analysis set included all participants randomized to D/C/F/TAF group and received at least 1 dose of study drug in study, and for whom plasma concentration data of any analytes of interest were available. Here ‘n’ specifies participants who were analyzed for this endpoint at given time point.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2591545|NCT02269917|Secondary|Number of Participants With Resistance to Study Drug|HIV-1 genotypes were analyzed from samples of participants with confirmed virologic rebound (virologic rebound was defined as: confirmed HIV-1 RNA >=50 copies/mL up to, and including the upper bound of the Week 48 window) and with HIV-1 RNA value greater than or equal to (>=)400 copies/mL or who discontinued with last HIV-1 RNA >=400 copies/mL. Number of participants who developed resistance to any of the study drug was determined.|Up to Week 48|The ITT population with confirmed virologic rebound and with HIV-1 RNA value >=400 copies/mL was analyzed.|||Participants|||Number
2591546|NCT02269917|Secondary|Percentage of Participants With Treatment Adherence of >95% (Approach 2) Through Week 48|Treatment adherence (defined as adherence of >95%) was assessed by the drug accountability cumulative treatment adherence up to time point where not more than one bottle was missing, or if available, through Week 48, whichever came sooner (Approach 2).|Through Week 48|ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) indicates the number of participants evaluable for this endpoint.|||Percentage of Participants|||Number
2591547|NCT02269917|Secondary|Percentage of Participants With Treatment Adherence of Greater Than (>)95 Percent (%) (Approach 1) Through Week 48|Treatment adherence (defined as adherence of >95%) was assessed by the drug accountability cumulative through Week 48 (Approach 1).|Through Week 48|ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, N (number of participants analyzed) indicates the number of participants evaluable for this endpoint.|||Percentage of Participants|||Number
2591548|NCT02269917|Secondary|Change From Baseline in Cluster of Differentiation 4 Plus (CD4+) Cell Count at Weeks 24 and 48|Change from baseline in CD4+ cell count was assessed at Weeks 24 and 48.|Baseline, Weeks 24 and 48|ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here ‘n’ specifies those participants who were analyzed for this endpoint at given time point.|||Cells per cubic millimeter (cells/mm^3)||Standard Error|Mean
2591550|NCT02269917|Secondary|Percentage of Participants With Virologic Response Based on HIV-1 RNA Less Than (<)20, <50, and <200 Copies/mL Threshold at Week 48 as Defined by the Food and Drug Administration (FDA) Snapshot Approach|Percentage of participants with virologic response based on HIV-1 RNA <20, <50, and <200 copies/mL threshold were analyzed at Week 48 using FDA snapshot approach. FDA Snapshot approach analysis was based on the last observed viral load data: virologic response was defined as HIV-1 RNA <20/50/200 copies/mL (observed case).|Week 48|ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2591551|NCT02269917|Secondary|Percent Change From Baseline in Urine Fractional Excretion of Phosphate (FEPO4) at Weeks 24 and 48|Percent change from baseline in urine FEPO4 was assessed at Weeks 24 and 48.|Baseline, Weeks 24 and 48|ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here ‘n’ specifies those participants who were analyzed for this endpoint at given time point.|||Percent change||Full Range|Median
2591552|NCT02269917|Secondary|Change From Baseline in Urine Retinol Binding Protein to Creatinine Ratio (URBPCR) and Urine Beta-2 Microglobulin to Creatinine Ratio (UB2MGCR) at Weeks 24 and 48|Change from baseline in URBPCR and UB2MGCR was assessed at Weeks 24 and 48. Retinol binding protein is a marker of proximal tubular function.|Baseline, Weeks 24 and 48|ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, N (number of participants analyzed) indicates number of participants evaluable for this endpoint; and ‘n’ specifies those participants who were analyzed for this endpoint at given time point.|||microgram per gram (mcg/g)||Full Range|Median
2591553|NCT02269917|Secondary|Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) and Urine Protein to Creatinine Ratio (UPCR) at Weeks 24 and 48|Change from baseline in UACR and UPCR was assessed at Weeks 24 and 48. Lower levels of albumin or protein in the urine indicates better proximal tubular function.|Baseline, Weeks 24 and 48|ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, N (number of participants analyzed) indicates number of participants evaluable for this endpoint; and ‘n’ specifies those participants who were analyzed for this endpoint at given time point.|||milligram per gram (mg/g)||Full Range|Median
2591554|NCT02269917|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst, by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at Weeks 24 and 48|Change from baseline in eGFRcyst (by CKD-EPI) was assessed at Weeks 24 and 48. eGFRcyst according to the CKD-EPI formula - 1) Serum Cystatin C (Scyst) <=0.8 mg/L: 133*(Scyst/0.8)^-0.499*0.996age (*0.932 if female); 2) Scyst >0.8 mg/L: 133*(Scyst/0.8)^-1.328*0.996age (*0.932 if female).|Baseline, Weeks 24 and 48|ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, ‘n’ specifies those participants who were analyzed for this endpoint at given time point.|||mL/min/1.73 m^2||Standard Error|Least Squares Mean
2591555|NCT02269917|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr, by Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) at Weeks 24 and 48|Change from baseline in eGFRcr (by CKD-EPI) was assessed at Weeks 24 and 48. eGFRcr per CKD-EPI formula - Female: 1) Serum creatinine (Scr) less than or equal to (<=)0.7 mg/dL: 144*(Scr/0.7)^-0.329*0.993age; 2) Scr greater than (>)0.7 mg/dL: 144*(Scr/0.7)^-1.209*0.993age. Male: 1) Scr <=0.9 mg/dL: 141*(Scr/0.9)^-0.411*0.993age; 2) Scr >0.9 mg/dL: 141*(Scr/0.9)^-1.209*0.993age.|Baseline, Weeks 24 and 48|ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, N (number of participants analyzed) indicates number of participants evaluable for this endpoint; and ‘n’ specifies those participants who were analyzed for this endpoint at given time point.|||mL/min/1.73 m^2||Standard Error|Least Squares Mean
2591556|NCT02269917|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr, by Cockcroft-Gault Formula [eGFRcg]) at Weeks 24 and 48|Change from baseline in eGFRcr (by Cockcroft-Gault formula) was assessed at Weeks 24 and 48. eGFRcr according to the Cockcroft Gault formula- Male: (140 - age in years)*(weight in kilogram [kg])/72*(serum creatinine in milligram per deciliter [mg/dL])=eGFRcr (milliliter per minute [mL/min]); Female: (140 - age in years)*(weight in kg)/72*(serum creatinine in mg/dL)*0.85=eGFRcr (mL/min).|Baseline, Weeks 24 and 48|ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment. Here, N (number of participants analyzed) indicates number of participants evaluable for this endpoint; and ‘n’ specifies those participants who were analyzed for this endpoint at given time point.|||milliliter per minute (mL/min)||Standard Error|Least Squares Mean
2591557|NCT02269917|Secondary|Change From Baseline in Serum Creatinine Levels at Weeks 24 and 48|Change from baseline in serum creatinine levels at Weeks 24 and 48 was assessed.|Baseline and Weeks 24 and 48|ITT analysis set included all participants randomized and received at least 1 dose of study treatment. Here, N (number of participants analyzed) indicates number of participants evaluable for this endpoint; and ‘n’ specifies participants analyzed for this endpoint at given time point.|||micro mole per liter||Standard Error|Least Squares Mean
2591558|NCT02269917|Secondary|Percentage of Participants Experiencing Grade 3 and 4 Adverse Events (AEs)|An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (Severe) events were symptoms causing inability to perform usual social & functional activities. Grade 4 (Life-threatening) events were symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death.|Up to Week 48|ITT analysis set included all the participants who were randomized and received at least 1 dose of study treatment.|||Percentage of Participants|||Number
2591559|NCT02269917|Secondary|Time to Virologic Rebound|Time to virologic rebound was calculated from baseline until the first rebound time point (that is, time point before confirmation of rebound). Virologic rebound was defined as: confirmed plasma HIV-1 RNA >=50 copies/mL up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA >=50 copies/mL at premature discontinuation (irrespective of reason).|Baseline up to Week 48|ITT analysis set included all participants who were randomized and received at least 1 dose of study treatment.|||Weeks||95% Confidence Interval|Median
2591614|NCT02268955|Primary|Pain Score 120 Minutes After Study Medication Administration|Pain is measured on a visual analog scale 0=no pain and 10=worst pain imaginable.|120 minutes post medication administration||||score on a scale||Full Range|Median
2591560|NCT02269917|Secondary|Percentage of Participants With Virologic Rebound (Plasma HIV-1 RNA >=200 Copies/mL) Cumulative Through 48 Weeks|Virologic rebound was defined as: confirmed plasma HIV-1 RNA >=200 copies/mL up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA >=200 copies/mL at premature discontinuation (irrespective of reason). Percentage of participants with virologic rebound were reported.|Through 48 Weeks|ITT analysis set included all participants who were randomized and received at least 1 dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2591561|NCT02269917|Secondary|Percentage of Participants With Virologic Rebound (Plasma HIV-1 RNA >=20 Copies/mL) Cumulative Through 48 Weeks|Virologic rebound was defined as: confirmed plasma HIV-1 RNA >=20 copies/mL up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA >=20 copies/mL at premature discontinuation (irrespective of reason). Percentage of participants with virologic rebound were reported.|Through 48 Weeks|ITT analysis set included all participants who were randomized and received at least 1 dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2591562|NCT02269917|Primary|Percentage of Participants With Virologic Rebound (HIV-1 RNA >=50 Copies/mL) Cumulative Through Week 48|Virologic rebound was defined as: confirmed plasma human immunodeficiency virus - 1 (HIV-1) Ribonucleic Acid (RNA) level greater than or equal to (>=)50 copies per milliliter (copies/mL) up to, and including the upper bound of the Week 48 window (ie, 54 weeks) and last available on-treatment (single) HIV-1 RNA >=50 copies/mL at premature discontinuation (irrespective of reason). Percentage of participants with virologic rebound were reported.|Through Week 48|Intent-to-treat (ITT) analysis set included all the participants who were randomized and received at least 1 dose of study treatment.|||Percentage of participants||95% Confidence Interval|Number
2591563|NCT02269787|Primary|Percent of Participants Who Had an Additional Inpatient Detoxification|Percent that had (yes) an additional inpatient detoxification 6 months following baseline assessment- additional inpatient detoxification was dichotomous, yes or no.|6-month follow-up|Of 298 baseline participants, 266 participated in follow-up at 6 months.|||Participants|||Count of Participants
2591564|NCT02269709|Secondary|IVC Pressure|Blood pressure in the IVC, the interior vena cava, was measured from a central line placed for patient care.|Baseline and Follow Up Number 1 (approximately 24 -72 hours later)|Subjects who had undergone the Fontan operation and who had a central line placed. Blood pressure values were obtained from chart review.|||mmHg||Standard Error|Mean
2591565|NCT02269709|Primary|Shear Wave Speed (Liver Stiffness)|ARFI shear wave speed measurements were done on the right lobe of the liver. Measurement units are m/s (meters per second). A total of 8 measurements were performed on each subject at each time point.The 8 values were performed on each subject and averaged.|0-6 months|As shown in the participant flow, data was not captured for follow up time points 1 and 2 for 1 participant. At time point 3 data is only available for 5 participants.|||meters per second||Standard Deviation|Mean
2591566|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pressure Mat Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions. Images were only recorded during the wall and clavicle position, not during the natural standing position. Pressure mat parameters were recorded for both arm positions and compared to the natural standing position (arms hanging on either side).|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions and pressure mat recording in the two positions and the natural standing position.|||percentage of pressure under||Standard Deviation|Mean
2591567|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Pelvic Sagittal Plane Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.|||degrees||Standard Deviation|Mean
2591568|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Transverse Plane Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.|||degrees||Standard Deviation|Mean
2591569|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Frontal Spinal Plane Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.|||degrees||Standard Deviation|Mean
2591570|NCT02269657|Primary|Impact of the Patients' Arm Positioning on Clinical Evaluation of Bi-planar Spinal X-rays Using the EOS System - Spinal Sagittal Plane Parameters|Spinal (coronal and sagittal) and sacro-pelvic parameters were used to evaluate the equivalence between the spinal and pelvic parameters in the two arm positions.|Up to 30 minutes|Each enrolled subject completed bi-planar full spinal x-rays in each of the two positions.|||degrees||Standard Deviation|Mean
2591571|NCT02269631|Secondary|Satiety|Use self-reported satiety questionnaire to compare short-term responses to test meals.|Time course response at baseline and 8 weeks|Data were collected but not analyzed due to a lack of funding.||||||
2591572|NCT02269631|Secondary|Energy Intake|Compare the effects of the high-legume and control diets on self-reported dietary intake measured by telephone 24-hour dietary recalls.|Baseline to 8 weeks|Data were collected but not analyzed due to a lack of funding.||||||
2591573|NCT02269631|Secondary|Change in Plasma Insulin Level (Biomarker of Appetite Regulation)|Compare the effects of the high-legume and control diets on plasma insulin level in a meal response time (30 min) course experiment.|Baseline to 8 weeks||||mg/dl||95% Confidence Interval|Mean
2591574|NCT02269631|Secondary|Gastric Emptying Time|Compare the effects of the high-legume and control diets on gastric emptying time|8 weeks||||hours||Full Range|Median
2591575|NCT02269631|Primary|Change in Weight|Evaluate the effects of a high-legume diet compared to a control diet with a similar macronutrient profile on weight change in a randomized controlled feeding study.|Baseline to 8 weeks||||lbs||Full Range|Median
2591576|NCT02269488|Primary|Number of Participants With Solicited Symptoms Experienced From Administration of MEDI3250|"Solicited symptoms experienced from administration of investigational product through 14 days post vaccination by dose number.~Solicited symptoms are events that are considered likely to occur post dosing. For this study, solicited symptoms include Fever ≥ 100.4°F (38.0°C) by any route, Runny/stuffy nose, Sore throat, Cough, Headache, Generalized muscle aches, Decreased activity level (lethargy) or tiredness/weakness, Decreased appetite and Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) will be omitted when, according to the judgment of the investigator, the subject is too young to reliably report a particular symptom"|14 days post vaccination||||subjects|||Number
2591577|NCT02269475|Secondary|the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain)|The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (matched strain, by strain)|through the end of the influenza surveillance period, up to end Apr (6 months)|Per Protocol Population|||Participants|||Number
2591578|NCT02269475|Secondary|the Incidence of Laboratory-confirmed Influenza Infection (Any Strain)|The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (any strain)|through the end of the influenza surveillance period, up to end Apr (6 months)||||Participants|||Number
2591579|NCT02269475|Primary|the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain)|The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (matched strain)|through the end of the influenza surveillance period, up to end Apr (6 months)|Per Protocol Population|||Participants|||Number
2591580|NCT02269423|Secondary|Mean Copy Number of Vector RNA (Vector Viremia)|Although the protocol specified a secondary endpoint that included the mean copy number of vector RNA (vector viremia), the Polymerase Chain Reaction (PCR) test used for the study reported a qualitative rather than a quantitative outcome, so the proportion of participants with viremia is reported instead of the mean copy number of vector RNA. Qualitative results are therefore reported in Outcome Measures 12 and 13.|Up to 14 days postvaccination|Although the plan specified in the protocol was to describe vector viremia by summarizing simple mean copy numbers of vector RNA, this data was not collected as the PCR results were qualitative rather than quantitative and were assessed in outcome measures # 12 and #13 instead.||||||
2591581|NCT02269423|Primary|Number of Participants With One or More Serious Adverse Event|An adverse event is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. The number of participants that experienced one or more SAE was summarized.|Up to 180 days postvaccination|All participants who received study vaccination (V920 dose level or placebo).|||Participants|||Count of Participants
2591582|NCT02269423|Secondary|Number of Participants With Vaccine Shedding/Excretion in Saliva or Urine|The number of participants with viremia detected by rVSV reverse transcription PCR of saliva or urine specimens was assessed.|Days 1, 3, 7, and 14 post-vaccination|All randomized subjects who were vaccinated and had an evaluable Day 28 immunogenicity result following vaccination and who did not have any protocol deviations that influenced interpretation of immunogenicity endpoints.|||Participants|||Count of Participants
2591583|NCT02269423|Secondary|Number of Participants With Vaccine Viremia|The number of participants with viremia detected by recombinant vesicular stomatitis virus (rVSV) reverse transcription polymerase chain reaction (PCR) of blood specimens was assessed.|Days 1, 3, 7, and 14 post-vaccination|All randomized subjects who were vaccinated and had an evaluable Day 28 immunogenicity result following vaccination and who did not have any protocol deviations that influenced interpretation of immunogenicity endpoints.|||Participants|||Count of Participants
2591584|NCT02269423|Secondary|Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies|The Geometric Mean Titers (GMT) of ZEBOV-specific neutralizing antibodies were measured by pseudovirion neutralization assays (PsVNA). Titers were reported for PsVNA50 values which were derived from the reciprocal of the dilution that resulted in a 50% decrease in luciferase activity. The LLOQ for the PsVNA was 20. If the PsVNA was reported ≤20, the numeric portion of the titer was divided by 2 for statistical purposes, which could result in a reported GMT <20.0. PsVNA50 titers at baseline (Day 0) and analysis Days 7, 14, 28, 56, and 180 were summarized by V920 vaccine dose level and placebo as the mean of log10 titers, transformed into GMT. The geometric standard deviation (GSD) for the GMT at each visit was obtained by exponentiating the standard deviation for the mean of log (base 10) transformed titers.|Baseline, Days 7, 14, 28, 56, and 180 post-vaccination|All randomized participants who were vaccinated and had an evaluable Day 28 immunogenicity result following vaccination and who did not have any protocol deviations that influenced interpretation of immunogenicity endpoints for the specified measurement and timeframe.|||titer||Standard Deviation|Geometric Mean
2591585|NCT02269423|Secondary|Geometric Mean Titers of ZEBOV Envelope Glycoprotein-specific Binding Antibodies|The Geometric Mean Titers (GMT) of ZEBOV-specific Immunoglobulin G antibodies were measured by unqualified ZEBOV immunoglobulin (IgG) enzyme-linked immunosorbent assay (ELISA). For titers expressed in ELISA Units/mL, the lower level of quantitation (LLOQ) was 58.84. ZEBOV IgG titers at baseline (Day 0) and analysis Days 7, 14, 28, 56, 84, and 180 were summarized by V920 vaccine dose level and placebo as the mean of log10 titers, transformed into GMT. The geometric standard deviation (GSD) for the GMT at each visit was obtained by exponentiating the standard deviation for the mean of log (base 10) transformed titers.|Baseline, Days 7, 14, 28, 56, 84 and 180 post-vaccination|All randomized participants who were vaccinated and had an evaluable Day 28 immunogenicity result following vaccination and who did not have any protocol deviations that influenced interpretation of immunogenicity endpoints for the specified measurement and timeframe.|||ELISA Units/mL||Standard Deviation|Geometric Mean
2591586|NCT02269423|Primary|Number of Participants With Early Study Discontinuation Due to an Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. The number of participants prematurely withdrawing from the study due to an AE was assessed.|Up to 28 days postvaccination|All randomized participants who received study vaccination (V920 dose level or placebo).|||Participants|||Count of Participants
2591587|NCT02269423|Primary|Number of Participants With One or More Vaccination-Related Unsolicited Treatment-Emergent Adverse Events (TEAE) by Severity|"An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. A related TEAE is defined as a TEAE that was possibly, probably, or definitely related to the vaccination as assessed by the investigator. AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA's Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The number of participants that experienced at least one unsolicited TEAE related to study vaccination was summarized by grade."|Up to 28 days postvaccination|All randomized participants who received study vaccination (V920 dose level or placebo).|||Participants|||Count of Participants
2591588|NCT02269423|Primary|Number of Participants With One or More Vaccination-Related Unsolicited Treatment-Emergent Adverse Events (TEAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. A related TEAE is defined as a TEAE that was possibly, probably, or definitely related to the vaccination as assessed by the investigator. The number of participants that experienced at least one unsolicited TEAE related to study vaccination was assessed.|Up to 28 days postvaccination|All randomized participants who received study vaccination (V920 dose or placebo).|||Participants|||Count of Participants
2591589|NCT02269423|Primary|Number of Participants With One or More Unsolicited Treatment-Emergent Adverse Events (TEAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. The number of participants that experienced at least one unsolicited TEAE was assessed. Unsolicited AEs occurred from the time of injection through 28 days following injection.|Up to 28 days postvaccination|All randomized participants who received study vaccination (V920 dose level or placebo).|||Participants|||Count of Participants
2591590|NCT02269423|Primary|Number of Participants With One or More Solicited Systemic Treatment-Emergent Adverse Events (TEAE) by Severity|An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A TEAE is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Systemic reactogenicity signs and symptoms include pyrexia (subjective and objective fever), chills, hyperhidrosis (sweats), myalgia, arthralgia, fatigue, headache, and gastrointestinal symptoms including nausea, vomiting, abdominal pain, and/or diarrhea. AEs were assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The number of participants that experienced at least 1 solicited systemic TEAE was summarized by grade. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.|Up to 14 days postvaccination|All randomized participants who received study vaccination (V920 dose level or placebo).|||Participants|||Count of Participants
2591591|NCT02269423|Primary|Number of Participants With One or More Solicited Systemic Treatment-Emergent Adverse Events (TEAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Systemic reactogenicity signs and symptoms include pyrexia (subjective and objective fever), chills, hyperhidrosis (sweats), myalgia, arthralgia, fatigue, headache, and gastrointestinal symptoms including nausea, vomiting, abdominal pain, and/or diarrhea. The number of participants that experienced at least one solicited systemic TEAE was assessed. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.|Up to 14 days postvaccination|All randomized participants who received study vaccination (V920 dose level or placebo).|||Participants|||Count of Participants
2591592|NCT02269423|Primary|Number of Participants With One or More Solicited Local Treatment-Emergent Adverse Events (TEAE) by Severity|"An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A TEAE is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Local reactogenicity signs and symptoms include pain, erythema (redness), and induration (swelling). AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA's Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The number of participants that experienced at least one solicited local TEAE was summarized by grade. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations."|Up to 14 days postvaccination|All randomized participants who received study vaccination (V920 dose level or placebo).|||Participants|||Count of Participants
2591593|NCT02269423|Primary|Number of Participants With One or More Solicited Local Treatment-Emergent Adverse Events (TEAE)|An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event (TEAE) is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Local reactogenicity signs and symptoms include pain, erythema (redness), and induration (swelling). The number of participants that experienced at least one solicited local TEAE was assessed. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.|Up to 14 days postvaccination|All randomized participants who received study vaccination (V920 dose level or placebo).|||Participants|||Count of Participants
2591594|NCT02269241|Other Pre-specified|Overall Pregnancies|Overall PI based on confirmed and on confirmed and suspected, non-confirmed pregnancies in total and by BMI and weight subgroups|up to 13 months|The population includes all ages subjects, non-breastfeeding women, who were randomized and received at least one dose of study drug, including confirmed and suspected, non-confirmed pregnancies.|||Pearl Index||95% Confidence Interval|Number
2591595|NCT02269241|Other Pre-specified|Number of Pregnancies (by BMI and Weight)|PI for evaluable cycles in women aged ≤ 35 years in total and by BMI and weight subgroups based on confirmed and on confirmed and suspected, non-confirmed pregnancies|up to 13 months|The population includes evaluable cycles in non-breastfeeding women aged ≤ 35 years , who were randomized and received at least one dose of study drug, including confirmed and suspected, non-confirmed pregnancies.|||Pearl Index||95% Confidence Interval|Number
2591596|NCT02269241|Secondary|Tolerability; Vaginal Bleeding Pattern|Vaginal bleeding pattern|up to 13 months|The population includes all subjects in full analysis set with bleeding.|||Subjects with bleeding|||Number
2591597|NCT02269241|Secondary|Number of Participants With Adverse Events as a Measure of Safety|Adverse events and changes in vital signs, clinical laboratory parameters|up to to 13 months|The population includes all subjects who received at least one dose of the IMP.|||Subjects|||Number
2591598|NCT02269241|Secondary|Overall PI, PI for Method Failures|Overall PI, PI for method failures, PI (using evaluable cycles) and pregnancy ratio (life table analysis) in all women and in women up to 13 months (confirmed pregnancies)|up to 13 months|The population includes all ages subjects who were randomized and received at least one dose of study drug, non-breastfeeding women and used the IMP correctly.|||Pearl Index||95% Confidence Interval|Number
2591599|NCT02269241|Secondary|Pregnancy Ratio|Pregnancy ratio in women aged ≤ 35 years (at the time of trial enrollment)|up to 13 months|The population includes all subjects aged ≤ 35 years who were randomized, received at least one dose of study drug with evaluable cycles.|||Cumulative Pregnancy Rate (%)||95% Confidence Interval|Number
2591600|NCT02269241|Secondary|Number of Pregnancies (Method Failures)|PI for method failures in women aged ≤ 35 years (at the time of trial enrollment) (confirmed pregnancies)|up to 13 months|The population includes all non-breastfeeding subjects aged ≤ 35 years who were randomized, received at least one dose of study drug and used the IMP correctly.|||Pearl Index||95% Confidence Interval|Number
2591601|NCT02269241|Secondary|Number of Pregnancies (All)|Pearl Index based on overall cycles (overall PI) in women aged ≤ 35 years (at the time of trial enrollment) (confirmed pregnancies)|up to 13 months|The population includes all non-breastfeeding subjects aged ≤ 35 years who were randomized and received at least one dose of study drug.|||Pearl Index||95% Confidence Interval|Number
2591602|NCT02269241|Primary|Number of Pregnancies (Evaluable Cycles)|"Pearl index (PI) from Evaluable Cycles in non-breastfeeding women aged ≤ 35 years (at the time of trial enrollment).~The PI calculation was based on the following formula:~PI(evaluable cycles)= (∑ on-drug confirmed pregnancy ∈{exposure cycles})/(#{exposure cycles} ) X 1300"|up to 13 months|The population includes all non-breastfeeding subjects aged ≤ 35 years who were randomized, received at least one dose of study drug with sexual activity without using back-up contraception.|||Pearl Index||95% Confidence Interval|Number
2591603|NCT02269098|Other Pre-specified|ED Visits and Hospitalizations|number ED visits and hospitalizations pre and post intervention as self-reported by participants|12 weeks|Self reported Number of ED visits and hospitalizations 3 months prior to and 3 months after the intervention|||number of ED visits and hospitlizations|||Number
2591604|NCT02269098|Secondary|Hypoglycemia|Hypoglycemia was defined as BG < 70mg/dL. Severe hypoglycemia was defined as BG <40mg/dL and/or requiring assistance to treat. We tracked the total number of hypoglycemia episodes in each group.|4 weeks|we collected data on the total number of hypoglycemia episodes in each group, not the number or participants with hypoglycemia as some participants had more than 1 episode and we wanted to capture those as separate incidents.|||total incidents of hypoglycemia|||Number
2591605|NCT02269098|Secondary|Blood Glucose < 180mg/dL|Number of patients in each group with BG < 180 mg/dl at 4 weeks from baseline|4 weeks||||participants|||Number
2591606|NCT02269098|Primary|Medication Adherence|"Score on 8 item Modified Morisky Medication Scale used to assess medication adherence. This scale is a structured and widely used self reported questionnaire used to assess medication taking behaviors.The total score ranges from 0 to 8. A score of 0 is considered highadherence, 1 to 2 is considered medium adherence, and >2 is considered low adherence."|4 weeks|33 patients in the intervention group and 30 in the control group completed the scale at baseline and at 4 weeks and their data was analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2591607|NCT02269098|Primary|Hemoglobin A1C at 4 Weeks|Hemoglobin A1C at index/baseline visit in the ED and at 4 weeks. A1C was measured using the Bayer A1C-Now+ point of care test system device. If the reading was over 13%, the upper limit of the assay, a venous sample A1C was sent to the hospital lab for analysis.|4 weeks|Participants who completed the full 4 week study period were included in the primary outcomes analysis.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2591608|NCT02268994|Secondary|Mean Change in Serum Phosphate at the End of 16 Weeks Minus Baseline|The difference of serum phosphate at 16 weeks compared to the serum phosphate value at the time of study entry.|Baseline and week 16||||mg/dL||Standard Error|Least Squares Mean
2591609|NCT02268994|Secondary|Percentage of Subjects Experiencing a Sustained Treatment Effect on Hemoglobin (Hgb)|Proportion of subjects that continued to maintain an increase in Hgb over a 4 week period, provided they had an increase of at least 1.0 g/dL during that 4-week period|Week 16||||Participants|||Count of Participants
2591610|NCT02268994|Secondary|Mean Change in Ferritin at the End of 16 Weeks Minus Baseline|The difference of ferritin at 16 weeks compared to the ferritin value at the time of study entry.|Baseline and week 16||||ng/mL||Standard Error|Least Squares Mean
2591611|NCT02268994|Secondary|Mean Change in Transferrin Saturation (TSAT) at the End of 16 Weeks Minus Baseline|The difference of TSAT at 16 weeks compared to the TSAT value at the time of study entry was averaged.|Baseline and week 16||||% saturation||Standard Error|Least Squares Mean
2591612|NCT02268994|Secondary|Mean Change in Hemoglobin (Hgb) at the End of 16 Weeks Minus Baseline|The difference of Hgb at 16 weeks compared to the Hgb value at the time of study entry.|Baseline and week 16||||g/dL||Standard Error|Least Squares Mean
2591613|NCT02268994|Primary|Percentage of Subjects Achieving an Increase in Hemoglobin of ≥1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period|Efficacy analyses were performed for the Intention-to-treat (ITT) population, the population consisted of all subjects who were randomized, had a baseline laboratory value, took at least 1 dose of study drug, and had at least 1 post-baseline laboratory assessment during the randomized period.|Week 16||||Participants|||Count of Participants
2591616|NCT02268942|Primary|Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months|"Alive on the originally implanted device at six months, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event); or~Transplanted by Month 6, and the subject has not had a stroke with a modified Rankin Scale~≥ 4 (assessed ≥ three months post-stroke event); or~Explanted for recovery by Month 6, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event)."|6 months||||Participants|||Count of Participants
2591617|NCT02268877|Primary|Emergency Department Length-of-Stay|The time the patient is placed in room to the time that the patient is discharged/admitted.|48 hours||||minutes||Inter-Quartile Range|Median
2591618|NCT02268877|Primary|Time to Definitive Diagnosis|The time the patient is placed in room to the time that results of the ultrasound (and/or consultative impression made by radiology or obstetrics and gynecology) are documented in patient chart|24 hours||||minutes||Inter-Quartile Range|Median
2591619|NCT02268864|Secondary|Number of Participants With Viral Relapse|Participants were considered to have had viral relapse if they did not achieve SVR12 and met the following conditions: had HCV RNA <LLOQ (undetectable) at EOT and had HCV RNA >=LLOQ during the follow-up period.|Up to Week 24 after actual EOT|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.|||participants|||Number
2591620|NCT02268864|Secondary|Number of Participants With Viral Breakthrough|Participants were considered to have had viral breakthrough if they had a confirmed greater than (>) 1.0 log10 international units/milliliter (IU/mL) increase in HCV RNA from nadir OR confirmed HCV RNA >100 IU/mL while previously having achieved HCV RNA <LLOQ when on study treatment.|Up to Week 24|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.|||participants|||Number
2591621|NCT02268864|Secondary|Percentage of Participants With On-treatment Failure|Participants were considered on-treatment failures if they did not achieve SVR12 and had (confirmed) detectable HCV RNA, ie, <LLOQ detectable or greater than equal to (>=) LLOQ at EOT.|Up to Week 24 after actual EOT|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.|||percentage of participants|||Number
2591622|NCT02268864|Secondary|Percentage of Participants With SVR 24 Weeks After End of Study Drug Treatment (SVR 24)|Participants were considered to have reached SVR24, if 24 weeks after the actual EOT, HCV RNA was <LLOQ (detectable or undetectable).|At 24 weeks after actual EOT|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.|||percentage of participants||95% Confidence Interval|Number
2591623|NCT02268864|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Study Drug Treatment (SVR4)|Participants were considered to have reached SVR4, if 4 weeks after the actual EOT, HCV RNA was <LLOQ (detectable or undetectable).|At 4 weeks after actual EOT|The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.|||percentage of participants||95% Confidence Interval|Number
2591624|NCT02268864|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)|Participants were considered to have reached SVR12, if 12 weeks after the actual end of treatment (EOT), hepatitis C virus (HCV) ribonucleic acid (RNA) was less than lower limit of quantification (<LLOQ) (detectable or undetectable).|At 12 weeks after end of treatment|The intent-to-treat (ITT) analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir.|||percentage of participants||95% Confidence Interval|Number
2591625|NCT02268812|Other Pre-specified|Change in the Actual Overall EuroQoL (EQ-5D) Health Score From First Visit to Month 12 and End of Study|The EQ-5D is a standardized instrument used to measure quality of life. It classifies health states across five domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each domain has three levels (no problems, some/moderate problems, extreme problems). A unique EQ-5D health state was defined by combining one level from each of the five dimensions. The response to the question of how good or bad the participant's health was today was given on a visual analogue scale of 0 to 100 millimeters (mm), where 0 meant the participant was in the worst imaginable health state today and 100 meant the participant was in the best imaginable health state today. The results for the Health Score were that of the calculated overall score of the five dimensions, where -0.594 is worst health and 1.00 is perfect health. Change is defined as change in actual from the First Visit.|Month 12 Visit, End of Study (Termination Visit)|ITT population. Missing items/values used in calculating the partially complete Health Score were imputed using last observation carried forward (LOCF).|||Scores on a scale||Standard Deviation|Mean
2591626|NCT02268812|Other Pre-specified|Changes in Primary Intrathecal Drug, Including Dose Adjustment and Intervals|Data for this outcome measure was collected as part of the participant's study visit, however was not analyzed as an efficacy endpoint for reporting.|12 months after the last patient was enrolled|Data for this outcome measure was collected as part of the participant's study visit, however was not analyzed as an efficacy endpoint for reporting.||||||
2591627|NCT02268812|Secondary|Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)|Safety assessments consisted of monitoring and recording all adverse events (AEs) and serious adverse events (SAEs), any therapeutic interventions including all drug therapies, vital signs, and creatine kinase (CK) if laboratory tests were taken by the physician as part of routine clinical practice. AEs were graded on a 3-point scale; 1) mild - discomfort noticed, but no disruption of normal daily activity, 2) moderate - discomfort sufficient to reduce or affect normal daily activity, 3) severe - incapacitating, with inability to work or to perform normal daily activity. A TEAE was defined as an adverse event (AE) with a start date on or after the date of the First Visit. Where a start date was missing, the AE was considered to be treatment-emergent.|From first dose up to 30 days after the last dose of study treatment, for up to approximately 4 years 4 months.|Safety population included all participants who had at least one dose of an IT therapy.|||Participants|||Count of Participants
2591641|NCT02268526|Primary|Number of Participants Who Require Preemptive HCMV Therapy|Number of participants who require preemptive HCMV therapy. The definition of requiring preemptive anti-HCMV therapy was meeting either one of the following conditions: 1. the plasma HCMV DNA level is >= 1000 copies/mL (with or without HCMV disease) or 2. the plasma HCMV DNA level is < 1000 copies/mL, but HCMV disease was reported|98 days|Full Analysis Set - included all 86 patients enrolled in the study|||Count of Participants|||Number
2591628|NCT02268812|Secondary|Overall Change in Pain Severity and Pain Interference From Baseline (Visit 1) to Termination Visit|"The BPI-SF survey is made up of two dimensions: pain intensity/severity and pain interference, with each dimension containing specific items that are graded (e.g. mood, walking ability, relations with other people, enjoyment of life, etc.). Each item was graded on an 11-point Likert scale. The pain intensity/severity survey was used to measure pain severity, where 0 was no pain and 10 was pain as bad as you can imagine for each item listed. The pain interference survey scored each item on a scale, where 0 was does not interfere to 10 was completely interferes. The change in pain severity and pain interference from Baseline (Visit 1) were calculated from the scores."|Baseline (Visit 1) to Termination Visit (12 Months after last participant was enrolled)|ITT LOCF population|||Scores on a scale||Standard Deviation|Mean
2591629|NCT02268812|Secondary|Overall Change in Pain Severity and Pain Interference From Baseline (Visit 1) to Month 12 (Visit 5)|"The Brief Pain Inventory-Short Form (BPI-SF) survey is made up of two dimensions: pain intensity/severity and pain interference, with each dimension containing specific items that are graded (e.g. mood, walking ability, relations with other people, enjoyment of life, etc.). Each item was graded on an 11-point Likert scale. The pain intensity/severity survey was used to measure pain severity, where 0 was no pain and 10 was pain as bad as you can imagine for each item listed. The pain interference survey scored each item on a scale, where 0 was does not interfere to 10 was completely interferes. The change in pain severity and pain interference from Baseline (Visit 1) were calculated from the scores."|Baseline (Visit 1) to Month 12 (Visit 5)|ITT LOCF population|||Scores on a scale||Standard Deviation|Mean
2591630|NCT02268812|Primary|Average Overall Change From Baseline (Visit 1) in Visual Analog Scale of Pain Intensity (VASPI)|"VASPI is a worldwide validated measure of pain intensity. A Visual Analog Score (VAS) for pain is determined by using a horizontal line, 100-millimeter (mm) in length, anchored by word descriptors at each end; no pain (0 mm) on the left end and worst imaginable pain (100 mm) on the right end. The participant was asked to mark on the line the point that they feel represents their current state of pain. A VAS for least pain (over last two weeks), usual pain (over last two weeks), and pain today was determined and averaged to derive the total VAS score ranging from 0 (no pain) to 100 (worst pain imaginable). A last observation carried forward (LOCF) dataset was used to account for missing data where First Visit data could be carried forward."|Month 8 (Visit 4), Month 12 (Visit 5), and Termination Visit (12 months after last participant was enrolled)|Intent-to-Treat (ITT) (LOCF) population included all participants who had at least one dose of an IT therapy. Total number of participants for the outcome measures (335) does not match the total number enrolled (219) due to participants switching between treatment arms as allowed per protocol.|||Units on a scale||Standard Deviation|Mean
2591631|NCT02268526|Secondary|Half-life (T1/2) for CSJ148 Only at Day 85|T1/2 is the terminal elimination half-life [time]|Day 85|Pharmacokinetics (PK) analysis set (CSJ148 only)- The PK analysis set included the 65 patients who received a dose of CSJ148|||day||Standard Deviation|Mean
2591632|NCT02268526|Secondary|Lambda_z for CSJ148 Only at Day 85|Lambda_z is the terminal elimination rate constant [1/day] at Day 85|Day 85|Pharmacokinetics (PK) analysis set (CSJ148 only)- The PK analysis set included the 65 patients who received a dose of CSJ148|||1/day||Standard Deviation|Mean
2591633|NCT02268526|Secondary|Accumulation Ratio(Racc) for CSJ148 Only at Day 85|Accumulation ratio(Racc) is Racc: Accumulation ratio, calculated by AUCtau (Day 85) divided by AUCtau (for the 1st dose at Day 1).|Day 1 and Day 85|Pharmacokinetics (PK) analysis set (CSJ148 only)- The PK analysis set included the 65 patients who received a dose of CSJ148|||Ratio||Standard Deviation|Mean
2591634|NCT02268526|Secondary|Trough Serum Concentration (Ctrough) for CSJ148 Only|Ctrough is The observed plasma (or serum or blood) concentration at the end of a drug administration dosing interval [ug / mL]|Day 1, Day 29, Day 57, Day 85 at predose (0hr) and 3,6,24 hrs post dose|Pharmacokinetics (PK) analysis set (CSJ148 only)- The PK analysis set included the 65 patients who received a dose of CSJ148|||ug/mL||Standard Deviation|Mean
2591635|NCT02268526|Secondary|Maximum Serum Concentration During the Dosing Interval (Cmax) for CSJ148 Only|Cmax is the observed maximum plasma (or serum or blood) concentration following drug administration [ug / mL] for CSJ148 only|Day 1, Day 29, Day 57, Day 85 at predose (0hr) and 3,6,24 hrs post dose|Pharmacokinetics (PK) analysis set (CSJ148 only)- The PK analysis set included the 65 patients who received a dose of CSJ148|||ug/mL||Standard Deviation|Mean
2591636|NCT02268526|Secondary|Area Under the Serum Concentration-time Curve During the Dosing Interval (AUCtau) for CSJ148 Only|PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The AUCtau was calculated using a linear trapezoidal method|Day 1, Day 29, Day 57, Day 85 at predose (0hr) and 3,6,24 hrs post dose|Pharmacokinetics (PK) analysis set (CSJ148 only)- The PK analysis set included the 65 patients who received a dose of CSJ148|||day*ug/mL||Standard Deviation|Mean
2591637|NCT02268526|Secondary|Proportion of Participants Developing HCMV Disease|Proportion of participants developing HCMV disease|98 days|PD analysis set (Cohort 2) -included 59 patients, 27 patients (31%) were excluded.|||proportion of participants||90% Confidence Interval|Number
2591638|NCT02268526|Secondary|Number of Times That Preemptive HCMV Therapy is Required -Cohort 2|Among those who required preemptive therapy, the number of times preemptive therapy was required. (Cohort 2)|98 days|PD analysis set (Cohort 2) -included 59 patients, 27 patients (31%) were excluded.|||number of times||90% Confidence Interval|Least Squares Mean
2591639|NCT02268526|Secondary|Time to Start of Preemptive HCMV Therapy Cohort 2|The time to start preemptive therapy is defined as the number of days between initial dose of study drug and the earlier of (1) the start of preemptive therapy, and (2) the development of HCMV disease or death due to HCMV disease, or (3) censored at the EoT visit if no therapy required for Cohort 2|98 days|PD analysis set (Cohort 2) -included 59 patients, 27 patients (31%) were excluded.|||days||Standard Deviation|Mean
2591640|NCT02268526|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Number of participants with adverse events as a measure of safety and tolerability. Patients treated with CSJ148 in Cohorts 1 and 2 were pooled to simplify the safety analyses.|98 days|Safety Analysis Set- Eighty-six patients were enrolled in the study and all were included in the safety analysis set|||Count of Participants|||Number
2591642|NCT02268396|Secondary|Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count|Percentage of Correct Advances (±2 or ±4 Actuations) of the Dose Indicator Based on Subject-reported Actuation Count|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population|||Percentage of correct advances|||Number
2591644|NCT02268396|Secondary|Percentage of Devices in Agreement Between Laboratory-advanced Does Indicator Actuation and Weight-based Actuation Count at Last Available Visit.|Percentage of devices whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population|||Percentage|||Number
2591645|NCT02268396|Secondary|Percentage of Devices in Agreement Between Laboratory-Advanced Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit|Percentage of devices whose number of actuations counted at the end of the study, using the lab-advanced dose indicator reading, was consistent (±20 actuations) with the number of actuations used as reported by the subject|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population|||Percentage of devices|||Number
2591646|NCT02268396|Secondary|Percentage of Devices in Agreement Between eCRF-Based Dose Indicator Actuation Count and Weight-Based Actuation Count at the Last Available Visit|Percentage of devices whose number of actuations counted at the end of the study, using the dose indicator reading, was consistent (±20 actuations) with the number of actuations used as estimated by the change in MDI weight|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population|||Percentage of Devices|||Number
2591647|NCT02268396|Primary|Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count|Dose Indicator Actuation Consistency: Percentage of Devices in Agreement Between CRF-Based Dose Indicator Actuation Count and Subject-Reported Actuation Count at the Last Available Visit: ITT Population|Over the life of the canister/120 puffs - up to 4 weeks|ITT Population|||Percentage|||Number
2591648|NCT02268214|Secondary|Subjects With HbA1c Reduction From Baseline to Week 24 (LOCF) >= 0.5% and Without Severe Hypoglycemia Events|Subjects with HbA1c reduction from baseline to week 24 (LOCF) >= 0.5% and without severe hypoglycemia events|From Baseline to Week 24|All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.|||Participants|||Count of Participants
2591649|NCT02268214|Secondary|Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) From Baseline at Week 24|Adjusted Mean Change in Percent 24-hour Continuous Glucose Monitoring Glucose > 70 and <= 180 (mg/dL) from Baseline at Week 24 (Repeated Measures Model[RMM])|From Baseline to Week 24|All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.|||Percentage||Standard Error|Least Squares Mean
2591650|NCT02268214|Secondary|Adjusted Mean Change in 24-hour Continuous Glucose Monitoring MAGE From Baseline at Week 24|Adjusted Mean Change in 24-hour Continuous Glucose Monitoring Mean Amplitude of Glucose Excursions (MAGE) from Baseline at Week 24 (Repeated Measures Model[RMM])|From Baseline to Week 24|All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.|||mg/dL||Standard Error|Least Squares Mean
2591651|NCT02268214|Secondary|Adjusted Mean Change in 24-hour Mean Continuous Glucose Monitoring Glucose From Baseline at Week 24|Adjusted mean change in 24-hour mean Continuous Glucose Monitoring glucose from baseline at Week 24 (Repeated Measures Model[RMM])|From Baseline to Week 24|All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.|||mg/dL||Standard Error|Least Squares Mean
2591652|NCT02268214|Secondary|Adjusted Mean Percent Change in Body Weight From Baseline at Week 24|Adjusted mean percent change from baseline in body weight at Week 24 (Repeated Measures Model[RMM])|From Baseline to Week 24|All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.|||Kg||Standard Error|Least Squares Mean
2591653|NCT02268214|Secondary|Adjusted Mean Percent Change in Total Daily Insulin Dose From Baseline at Week 24|Adjusted mean change from baseline in Total Daily Insulin Dose at Week 24 (Repeated Measures Model[RMM])|From Baseline to Week 24|All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.|||IU||Standard Error|Least Squares Mean
2591654|NCT02268214|Primary|Adjusted Mean Change in HbA1c From Baseline at Week 24|Adjusted mean change from baseline in HbA1c at Week 24 (Repeated Measures Model[RMM]).|From Baseline to Week 24|All randomized subjects who took at least one dose of double-blind study medication during the short-term double-blind period. The first 55 randomized subjects will be excluded from the full analysis dataset due to the presence of a randomization system error.|||Percentage of hemoglobin||Standard Error|Least Squares Mean
2591655|NCT02268175|Secondary|Median Prostate Specific Antigen (PSA) Nadir|PSA nadir is the lowest PSA level recorded during neoadjuvant therapy.|PSA was assessed at baseline and every cycle during neoadjuvant therapy (up to 24 weeks).||||ng/mL||Full Range|Median
2591656|NCT02268175|Secondary|Positive Surgical Margin Status|Participants were classified by presence or absence of positive surgical margins defined as margins, which are the edges of the removed tumor, that show some cancer cells.|after RP approximately 24 weeks from study entry||||Participants|||Count of Participants
2591657|NCT02268175|Secondary|Residual Cancer Burden (RCB)|RCB was analyzed using radical prostatectomy (RP) tissue. The largest area of tumor was measured by ruler and the longest tumor dimension in this area was used as the dimension for calculation.|after RP approximately 24 weeks from study entry||||cm||Full Range|Median
2591658|NCT02268175|Secondary|Participants With Pathologic Complete Response (pCR)|pCR is defined as the absence of morphologically identifiable carcinoma in the radical prostatectomy (RP) specimen.|after RP approximately 24 weeks from study entry||||Participants|||Count of Participants
2591686|NCT02267603|Secondary|Progression-free Survival (PFS) Using RECIST 1.1|Survival curves for PFS will be estimated using the Kaplan-Meier method.|Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 16 months|||||||
2591659|NCT02268175|Primary|Percentage of Participants With Pathologic Complete Response (pCR) or Minimal Residual Disease (MRD)|pCR is defined as the absence of morphologically identifiable carcinoma in the radical prostatectomy (RP) specimen. MRD is defined as the largest cross-sectional dimension of residual tumor measuring </= 0.5 cm. If the tumor is multifocal, the size of the largest focus will be used to determine the size of the residual tumor.|after RP approximately 24 weeks from study entry||||percentage of participants||95% Confidence Interval|Number
2591660|NCT02268058|Other Pre-specified|Number of Headaches a Day|the patient family were given a headache diary and instruction to document the number of headaches they have a day for a one week period.|one week||||headaches per day||Full Range|Median
2591661|NCT02268058|Other Pre-specified|Headache Intensity Per Day for One Week|The Numerical Rating Scale (NRS) will be used to capture the intensity of the headache experience. The NRS was initially developed for acute post procedural pain and is now a common measure for headache and disease related pain with well established reliability and validity as a self report measure in this age group. Children meeting the inclusion criteria also meet the criteria for self report. The numerical rating scale includes indicators from 0 to 10 with 0 being the 'no pain' and 10 being 'the worst pain ever'. The child when diarizing the headaches will report a pain intensity score for each headache type in their one week headache diary. Study participants and their parent will be given instruction regarding reporting the headache instruction. The headache intensity scores were averaged for the day per participant.|one week||||units on a scale||Full Range|Median
2591662|NCT02268058|Secondary|Percentage of Study Participants That Returned to School at One Week Post Concussion|patients/family were asked if the child returned to school one week after their injury|one week||||percentage of participants|||Number
2591663|NCT02268058|Primary|Number of Headache Days|study participants completed a one week diary at home stating if they had headaches.|one week||||number of headache days||Full Range|Mean
2591664|NCT02268045|Secondary|Event Free Survival (EFS) in RTXM83 Arm and Mabthera® Arm|Time from randomization to any of the following events: progressive disease, no achievement of CR, PR associated with treatment in excess of that per protocol, SD, relapse after achievement of CR, or death from any cause, whichever comes first.|Up to FU3; 9 months after last dose of treatment|Number of patients with an EFS event (progressive disease, no achievement of CR, PR associated with treatment more than that per protocol, stable disease, relapse after achievement of CR, or death from any cause, whichever comes first).|||time (months)||95% Confidence Interval|Median
2591665|NCT02268045|Secondary|Comparable Immunogenicity Profile Between RTXM83 and Mabthera®|Anti-Drug Antibody (ADA) developed de novo (seroconversion) after 6 cycles of treatment and 9 months of follow-up.|Up to FU3; 9 months after last dose of treatment||||Participants|||Count of Participants
2591666|NCT02268045|Secondary|Comparable Safety Profile in Both Treatment Arms|Compare the frequency and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) reported in each treatment arm.|Up to FU3; 9 months after last dose of treatment|All patients receiving at least one dose of the study medication.|||Participants|||Count of Participants
2591667|NCT02268045|Secondary|Percentage Change From Baseline in Pharmacodynamic (PD) Markers (CD19+ and CD20+ Cells) Blood Counts of RTXM83 and Mabthera®|"CD19 and CD20 are proteins found on the cell surface of B cells, and they can be detected in peripheral blood by flow cytometry. Flow cytometry of peripheral blood was performed for immediate analysis of cells with cluster of differentiation 19 (CD19+) and CD20+.~To compare the percent Change From Baseline ((Cycle 1 pre-dose) in pharmacodynamic markers (CD19+ and CD20+ Cells) in Peripheral Blood achieved in RTXM83 and Mabthera® arms at Cycle 1 end of infusion (EOI), 6 months and 9 months after last dose of treatment."|Up to follow-up 3 (FU3); 9 months after last dose of treatment|Data were provided for the number of samples available at each visit.|||percentage change in cells||Full Range|Median
2591668|NCT02268045|Secondary|Cmax (μg/mL) at Cycle 6 of RTXM83 and Mabthera®|"Compare the PK parameter (Cmax) calculated from start of the first infusion until Day 21 of administration of Cycle 6 in a population PK model.~For the PK similarity assessments, regulatory guidelines on bioequivalence were followed whereby two treatments are judged not to be different from one another if the 90% confidence interval (CI) of the ratio between the geometric means of the measure (AUC 0-∞ ) falls completely within the range 80%-125%."|Cycle 6 (last dose): Day 1, Day 8, Day 15 and Day 21||||μg/mL||Geometric Coefficient of Variation|Geometric Least Squares Mean
2591669|NCT02268045|Secondary|Cmax (μg/mL) at Cycle 1 of RTXM83 and Mabthera®|"Compare the PK parameter (Cmax) calculated from start of the first infusion until start of the second infusion (i.e. at Cycle 1) in a population PK model.~For the PK similarity assessments, regulatory guidelines on bioequivalence were followed whereby two treatments are judged not to be different from one another if the 90% confidence interval (CI) of the ratio between the geometric means of the measure (Cmax) falls completely within the range 80%-125%."|Cycle 1 (first dose): Day 1 (pre-dose, mid-infusion), Day 8 and Day 15||||μg/mL||Geometric Coefficient of Variation|Geometric Least Squares Mean
2591670|NCT02268045|Secondary|AUC 0-∞ (h μg/mL) at Cycle 6 of RTXM83 and Mabthera®|"Compare the PK parameter (AUC 0-∞) calculated from start of the first infusion until Day 21 of administration of Cycle 6 in a population PK model.~For the PK similarity assessments, regulatory guidelines on bioequivalence were followed whereby two treatments are judged not to be different from one another if the 90% confidence interval (CI) of the ratio between the geometric means of the measure (AUC 0-∞ ) falls completely within the range 80%-125%."|Cycle 6 (last dose): Day 1, Day 8, Day 15 and Day 21||||ng.h/mL||Geometric Coefficient of Variation|Geometric Least Squares Mean
2591671|NCT02268045|Secondary|AUC 0-∞ (h μg/mL) at Cycle 1 of RTXM83 and Mabthera®|"Compare the pharmacokinetic (PK) parameter (AUC 0-∞) calculated from start of the first infusion until start of the second infusion (i.e. at Cycle 1) in a population PK model.~For the PK similarity assessments, regulatory guidelines on bioequivalence were followed whereby two treatments are judged not to be different from one another if the 90% confidence interval (CI) of the ratio between the geometric means of the measure (AUC 0-∞ ) falls completely within the range 80%-125%."|Cycle 1 (first dose): Day 1 (pre-dose, mid-infusion), Day 8 and Day 15||||ng.h/mL||Geometric Coefficient of Variation|Geometric Least Squares Mean
2591701|NCT02267317|Secondary|Effect of Eritoran on Plasma TNF-alpha (Tumor Necrosis Factor-alpha) Concentration|TNF-alpha levels are determined by ELISA. Higher level indicates higher inflammatory response. There is no established reference range.|72 hours|Data from T2DM subjects and Lean subject were not analyzed because the number of participants was insufficient in the 2 groups.|||pg/ml||Standard Error|Mean
2591672|NCT02268045|Primary|Response Rate (RR) Achieved After Cycle 6 With RTXM83 Plus CHOP Compared to the RR Obtained With Mabthera® Plus CHOP (R-CHOP) in Patients With DLBCL|Per International Working Group (IWG) revised criteria for Malignant Lymphomas (Cheson et al. 2007) and assessed by positron-emission tomography scan, or by computed tomography scan and/or magnetic resonance imaging if Positron Emission Tomography (PET) scan was not feasible. Tumor response was classified according to the International Working Group criteria, as Complete Remission (CR): Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; Partial Response (PR): At least a 50% decrease in sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses; Stable disease (SD) or; Progressive disease. Response rate was the sum of CR and PR.|Tumor response assessed after Cycle 6 or at the end of treatment|The Intent-to-treat (ITT) population and the Per Protocol (PP) population|||percentage of participants||95% Confidence Interval|Number
2591673|NCT02267850|Primary|Overall Orthodontic Treatment Time for OrthoPulse™ and Non-OrthoPulse™ Treated Patients.|The amount of time that spans between the start of a patient's orthodontic treatment to when the qualified investigator deems the case complete, in that malocclusion is completely resolved and an acceptable clinical outcome is achieved.|Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case.||||months||Standard Deviation|Mean
2591674|NCT02267837|Primary|Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for OrthoPulse™ and Non-OrthoPulse™ Treated Patients.||Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case.||||millimeters per week (mm/wk)|arches|Standard Deviation|Mean
2591675|NCT02267824|Primary|Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for Extraoral OrthoPulse® PBM and Non-OrthoPulse® PBM Treated Patients.||Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case.||||millimeters per week (mm/wk)||Standard Deviation|Mean
2591676|NCT02267811|Secondary|Degree of External Apical Root Resorption (EARR)|"The amount of EARR experienced as assessed at six (6) months or later after starting treatment. External Apical Root Resorption can result from orthodontic tooth movement. External apical root resorption is the shortening of the root and affects root surface(s), which can result in loss of tooth structure. External apical root resorption is being determined in this study by comparing root lengths from initial to six (6) months or later after starting treatment. The measurements are taken from the crown to the root apex in millimeters.~A positive number under the measure of dispersion signifies root resorption."|Assessed at six (6) months or later after starting treatment, up to two (2) years.|The overall number of participants is not consistent with the number of participants analyzed in this arm because the panoramic radiographs required to analyze the EARR were not available for the remaining 11 participants.|||millimeters||Standard Deviation|Mean
2591677|NCT02267811|Secondary|Safety Evidence of OrthoPulse™ Use|The number of significant adverse events reported from time of participant enrolment to study completion for all study participants|Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case.||||Adverse Events|||Number
2591678|NCT02267811|Primary|Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment|Rate of participants orthodontic tooth movement using Little's Index of Irregularity (LII) measured in millimeters per week during alignment.|Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case.||||millimeters per week||Standard Deviation|Mean
2591679|NCT02267629|Secondary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.|Baseline and 4 Weeks||||Participants|||Count of Participants
2591680|NCT02267629|Primary|Scores Change in Yale-Brown Obsessive Compulsive Challenge Scale (YBOCCS) Scores From Baseline to 230 Minutes Postinfusion.|Patients self-rated the severity of their obsessions and compulsions using the YBOC Challenge Scale, a 10-item self-report form that assesses Obsessive Compulsive Disorder (OCD) symptoms (i.e., time spent, degree of control, severity) [total score range = 0 - 40 ] over the previous 60 minutes. The higher the number on the YBOCCS, the more severe the symptoms.|Baseline and 230 minutes post infusion||||units on a scale||Standard Deviation|Mean
2591681|NCT02267603|Other Pre-specified|Merkel Polyomavirus (MCPyV)-Specific Immune Response, Assessed With Enzyme-linked Immunosorbent Spot and Serology Assays|Responses will be assessed at baseline, after initiating therapy, and correlated with clinical responses over time. Among patients with corresponding MHC-peptide tetramers, pre- and post-treatment samples of circulating MCPyV-specific CD8 T cells will be isolated and subjected to deep immunophenotyping by messenger ribonucleic acid (mRNA) expression analysis.|After 2 years of treatment|||||||
2591682|NCT02267603|Other Pre-specified|Immune Correlates of the Clinical Activity of Pembrolizumab|This will include immunohistochemical and gene expression analysis focusing on delineating the immune components and immunologic milieu within the tumor before therapy.|Baseline|||||||
2591683|NCT02267603|Secondary|Incidence of Adverse Events (AEs) Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0|Safety will be assessed by quantifying the toxicities and grades experienced by subjects including serious AEs (SAEs) and events of clinical interest. Safety and tolerability will be assessed by clinical review of all relevant parameters including AEs, laboratory tests, vital signs, and electrocardiogram measurements. Adverse experiences will be summarized as counts and frequencies by toxicity grade. Summary statistics (median and range) for time to onset of first drug-related toxicity will be provided.|Up to 90 days post-treatment|||||||
2591684|NCT02267603|Secondary|Overall Survival (OS)|Survival curves for OS will be estimated using the Kaplan-Meier method.|Time interval between the start of treatment to death due to any cause, assessed up to 3 years|||||||
2591687|NCT02267603|Primary|Objective Response Rate (ORR) Defined as the Proportion of Patients Who Have Achieved Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|ORR will be estimated as the number of responders as a percent of the number of eligible participants who received at least one dose of treatment. If a substantial amount of data is missing, analyses will be performed using parametric generalized linear models fit by maximum likelihood. A generalized linear model for the ORR will use a binomial error distribution. The model will include as covariates all available baseline predictors of the missing outcomes. Responses to continued pembrolizumab will be chronicled and reported.|Up to 3 years||||Participants|||Count of Participants
2591688|NCT02267577|Primary|Percentage of Sphygmo Readings That Were With < 5 mmHg, < 10 mmHg, and < 15 mmHg of the Readings by the Gold Standard Sphygmomanometer.|"The British Hypertension society defines a specific criteria for the accuracy of a sphygmomanometer. Devices are graded according to the cumulative percentage of readings that have an absolute difference between the more favorable observer's mercury sphygmomanometer readings and the test device of < 5 mmHg, < 10 mmHg, and < 15 mmHg. A letter grade of A requires that over 60%, 85%, and 95% were achieved in the < 5 mmHg, < 10 mmHg, and <15 mmHg categories, respectively. A letter grade of B requires that over 50%, 75%, and 90% were achieved in the < 5 mmHg, < 10 mmHg, and <15 mmHg categories, respectively. The test device achieved a grade of (B/B) with the validation data from this study."|Blood pressure was measured an average of 9 times for each participant during their single visit and the mean of these measurements was recorded and used for analysis. The measurement period lasted approximately 30-45 minutes.|Data from nine participants of the original 81 who completed the study was excluded on account of the observer reporting a difficulty in hearing, movement, or uncertainty with the measurement.|||percentage of measurements in that range|||Number
2591689|NCT02267577|Primary|Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard.|Mean difference of systolic and diastolic blood pressure readings between Sphygmo device and the gold standard sphygmomanometer.|Blood pressure was measured an average of 9 times for each participant during their single visit and the mean of these measurements was recorded and used for analysis. The measurement period lasted approximately 30-45 minutes.|Data from nine participants of the original 81 who completed the study was excluded on account of the observer reporting a difficulty in hearing, movement, or uncertainty with the measurement.|||mmHg||Standard Deviation|Mean
2591690|NCT02267538|Other Pre-specified|Length of Stay in Hospital After Surgery|Results was presented as median (95% confidence interval).|From end of surgery until discharge from hospital or 30 days after surgery||||days||95% Confidence Interval|Median
2591691|NCT02267538|Other Pre-specified|Length of Stay in the Intensive Care Unit|Results was presented as median (95% confidence interval).|From end of surgery until discharge from Intensive Care Unit or 30 days after surgery||||hours||95% Confidence Interval|Median
2591692|NCT02267538|Other Pre-specified|Subjective Sleep Quality|Subjective sleep quality was assessed daily at 8 am during the first five days after surgery with the Numeric Rating Scale (NRS, 0 = best sleep, 10 = the worst possible sleep).|During the first five days after surgery||||units on a scale||Inter-Quartile Range|Median
2591693|NCT02267538|Other Pre-specified|Pain Intensity|Pain intensity was assessed daily at 8 am during the first five days after surgery with the Numeric Rating Scale (NRS, 0 = no pain, 10 = the worst possible pain).|During the first five days after surgery||||units on a scale||Inter-Quartile Range|Median
2591694|NCT02267538|Secondary|Incidence of Non-delirium Complications After Surgery|Non-delirium complications was defined as any conditions other than delirium that occurred during the first 30 days after surgery and required therapeutic intervention.Complications listed here were not considered adverse events in this study.|Occurrence of non-delirium complications will be monitored until 30 days after surgery.||||Participants|||Count of Participants
2591695|NCT02267538|Secondary|Cognitive Function|"Cognitive function was assessed with the Mini Mental State Examination (MMSE) at baseline (the day before surgery) and on the sixth day after surgery, and with modified telephone interview for cognitive status (m-TICS) on the 30th day after surgery.~The introduction of MMSE scale has been explained in the baseline part in the result section.~The Telephone Interview for Cognitive Status-modified scale(m-TICS) is one of the most popular telephone interview-based screening instruments for mild cognitive impairment and dementia. It consists 11 items including wordlist memory, orientation, attention, repetition, conceptual knowledge and nonverbal praxis, which score ranges from 0 to 48, with higher scores indicating better cognitive function"|on the sixth day after surgery, and on the 30th day after surgery|5 patients (3 in CTRL group and 2 in DEX group) did not complete the MMSE test on postoperative day 6;17 patients (12 in CTRL group and 5 in DEX group) did not complete the m-TICS test on postoperative day 30|||units on a scale||Inter-Quartile Range|Median
2591696|NCT02267538|Primary|Incidence of Postoperative Delirium|Delirium was assessed with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) twice daily during the first five days after surgery.|During the first five days after surgery||||Participants|||Count of Participants
2591697|NCT02267447|Other Pre-specified|Death Due to Causes Other Than CVD||up to 12 years||||deaths|||Number
2591698|NCT02267447|Primary|Major Cardiovascular Disease Event|The primary outcome of interest was a major CVD event resulting in hospitalization or sudden death from CVD. Respondents were followed from the survey administration date until the earliest of: incident event, death due to causes other than CVD (defined as a competing risk), loss to follow-up (defined as loss of health care eligibility), or end of study (31 December 2012).|up to 12 years||||Cardiovascular disease event|person-years||Number
2591699|NCT02267382|Primary|The Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes Through Week 48 of the Study in the Intent-to-treat Population.|"A culture-verified acute VVC episode was defined as a positive fungal culture for Candida species associated with a clinical signs and symptoms score of ≥3. To calculate the 'signs and symptoms' score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with higher scores indicating a worse outcome.~0 = none (complete absence of any sign or symptom)~= mild (slight)~= moderate (definitely present)~= severe (marked, intense)"|48 Weeks||||Participants|||Count of Participants
2591700|NCT02267317|Secondary|Effect of Eritoran on Intramyocellular Diacylglycerol and Ceramide Content|Intramyocellular diacylglycerol and ceramide content are determined by mass spectrometry. Higher levels have been associated with diabetes.|72 hours|Data were not collected due to lack of funding.||||||
2591702|NCT02267317|Secondary|Effect of Eritoran on TLR4 Expression in Peripheral Blood Monocytes|TLR4 expression in the peripheral blood monocytes is determined by flow cytometry using arbitrary units. Higher TLR4 expression indicates higher inflammatory response. There is no reference range.|72 hours|Data from T2DM subjects and Lean subject were not analyzed because the number of participants was insufficient in the 2 groups.|||AU||Standard Error|Mean
2591703|NCT02267317|Secondary|Effect of Eritoran on TLR4 Expresison in Adipose Tissue|TLR4 expression in the adipose tissue is determined by RNAseq using arbitrary units. Higher TLR4 expression indicates higher inflammatory response. There is no reference range.|72 hours|The total number of obese subjects enrolled is 9. However, we were only able to obtain fat biopsies from 4 subjects. In addition, data from T2DM subjects and Lean subject were not analyzed for this secondary outcome measure because of insufficient number of participants in the 2 groups.|||AU||Standard Deviation|Mean
2591704|NCT02267317|Secondary|Effect of Eritoran on TLR4 Expression in Muscle Tissue|TLR4 expression in muscle tissue is determined by RNAseq using arbitrary units. Higher TLR4 expression indicates higher inflammatory response. There is no reference range.|72 hours|The total number of obese subjects enrolled is 9. However, we were only able to obtain muscle biopsies from 7 subjects. In addition, data from T2DM subjects and Lean subject were not collected for this secondary outcome measure because of insufficient number of participants in the 2 groups.|||AU||Standard Error|Mean
2591705|NCT02267317|Primary|Effect of Eritoran on Hepatic Insulin Sensitivity|Hepatic insulin sensitivity = is determined by euglycemic hyperinsulinemic clamp procedure. Endogenous glucose production or EGP (mg/kg/min) calculated from the clamp is measured. Lower EGP indicates better hepatic insulin sensitivity. There is no established reference range.|72 hours|Data from T2DM subjects and Lean subject were not collected for primary outcome measure because of insufficient number of participants in the 2 groups.|||mg/kg/min||Standard Error|Mean
2591706|NCT02267317|Primary|Effect of Eritoran on Muscle Insulin Sensitivity|Muscle insulin sensitivity = muscle insulin sensitivity is determined by euglycemic hyperinsulinemic clamp procedure. M value (mg glucose / kg of body weight / minute) calculated from the clamp is measured. Higher M value indicates better insulin sensitivity. There is no established reference range.|72 hours|Data from T2DM subjects and Lean subject were not collected for primary outcome measure because of insufficient number of participants in the 2 groups.|||mg/kg/min||Standard Error|Mean
2591707|NCT02267278|Secondary|Toxicity of Combination of Ruxolitinib With Pracinostat|Toxicity defined as Grade 3-4 clinically relevant non-hematologic toxicity or a serious adverse event that is at least possibly related to the study drug (Common Terminology Criteria for Adverse Events CTCAE version 4.0).|3 months||||Participants|||Count of Participants
2591708|NCT02267278|Primary|Objective Response Rate (ORR)|Objective response rate (ORR), defined as a clinical improvement (CI), partial remission (PR), and complete remission (CR) according to the International Working Group (IWG) Criteria. Complete remission (CR): bone marrow blasts <5%, hemoglobin >/= 10, absolute neutrophil count (ANC) >/= 1000, platelets >/= 100, <2% immature myeloid cell, spleen and liver not palpable. Partial Response (PR): CR plus one or more of the following: ANC >/= 1000, decreased platelets by 50%, hemoglobin >/= 8.5 but < 10, <2% immature myeloid cells. Clinical improvement (CI): hemoglobin increase of 2g/dl, transfusion independence or reduction splenomegaly and/or hepatomegaly >/= 50%, >/=50% reduction in MPN-SAF TSS|3 months||||Participants|||Count of Participants
2591709|NCT02267226|Other Pre-specified|Analysis of Safety: Immunogenicity Testing for Anti-fibrinogen Antibodies|Immunogenicity testing for the presence of anti-fibrinogen antibodies at Day 14 and Day 30 after the administration of Octafibrin for bleeding. An experimental non-standard ELISA was developed for this study for evaluating anti-fibrinogen antibodies. No specific test was performed to discern for neutralizing antibodies. The clinical implications of the assay results are not known.|Up to 30 days (start of the first Octafibrin infusion until the end of each 30-day observation and follow-up period for on-demand treatment or until the Last Post-Operative Day in surgeries)||||Participants|||Count of Participants
2591710|NCT02267226|Secondary|Efficacy of Octafibrin in Preventing Bleeding During and After Surgery|The efficacy of Octafibrin will be assessed at the end of surgery by the surgeon and post-operatively by the haematologist using two 4-point haemostatic efficacy scales. An overall efficacy assessment taking both the intra- and post-operative assessment into account will be adjudicated by the IDMEAC|First dose of Octafibrin administered prior to elective surgery to at least 3 post-operative days for minor and 7 post-operative days for major surgeries or last post-operative infusion, whichever comes last||||Surgeries|Surgeries||Count of Units
2591711|NCT02267226|Secondary|Efficacy of Octafibrin for All Bleeding Episodes Collected in the Study|The investigator's overall clinical assessment of haemostatic efficacy for bleeding will be based on a 4-point haemostatic efficacy scale. The final efficacy assessment of each patient will be adjudicated by the Independent Data Monitoring & Endpoint Adjudication Committee (IDMEAC)|24 hours after last infusion for each bleeding episode||||BEs|BEs||Count of Units
2591712|NCT02267226|Secondary|Response as Indicated by Incremental in Vivo Recovery (IVR)|Incremental IVR (response): calculated as the maximum increase in plasma fibrinogen (i.e., Clauss data) between pre-infusion and 1 and 3 hours post-infusion, divided by the exact dose of Octafibrin.|Pre-infusion and 1 and 3 hours post-infusion||||mg/dL/(mg/kg)|BEs|Standard Deviation|Mean
2591713|NCT02267226|Secondary|Fibrinogen Plasma Level|Fibrinogen plasma level was assessed using the Clauss fibrinogen assay|Before (pre-infusion), 1 hour and 3 hours after the end of each subsequent infusion as well as at the time of the overall clinical assessment of haemostatic efficacy (i.e., 24 hours after the last infusion of each documented bleeding episode)||||mg/dL|BEs|Standard Deviation|Mean
2591714|NCT02267226|Secondary|Maximum Clot Firmness (MCF) After Fibrinogen Infusion in Each Documented Bleeding Episode (BE), Measured in Frozen Plasma in a Central Laboratory.|MCF (mm) was determined using ROTEM and was used as a surrogate marker for haemostatic efficacy. ROTEM is a method for the continuous measurement of clot formation and clot firmness. It utilises a mechanical detection system which is based on the ability of the blood or plasma clot to form a mechanical coupling over a distance of 1 mm.|Before first infusion and 1 hour after end of first and last infusion of each documented bleeding episode||||mm|Bleeding Episodes (BEs)|Standard Deviation|Mean
2592050|NCT02262039|Secondary|Subjective Pain Score|Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0)- A score of 0 indicates no pain.|6 hours post-op||||units on a scale||Standard Deviation|Mean
2591715|NCT02267226|Primary|Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in Treating the First Documented Bleeding Episode of Each Patient.|"The first bleeding episode covers the time period from the first Octafibrin infusion until 24 hours (i.e., 1 day) after the last infusion.~The investigator's overall clinical assessment of haemostatic efficacy for bleeding was based on a 4 point haemostatic efficacy scale. The final efficacy assessment of each patient was adjudicated by the Independent Data Monitoring & Endpoint Adjudication Committee (IDMEAC)."|24 hours after last infusion for each bleeding episode||||Participants|||Count of Participants
2591716|NCT02267187|Secondary|Assessment of Cellular Properties of the Cells Within the Fat Graft|Properties will be assessed via flow cytometry to measure the percentage of ASCs (adipose stem cells) within the SVF (stromal vascular fraction) from the fat graft.|Assessed at time of operative procedure||||percentage of ASCs within the SVF||Standard Deviation|Mean
2591717|NCT02267187|Primary|Facial Volume Appearance of Each Subject Was Evaluated by the Clinician at Screen, 7-21 Days, 3, and 9 Months Post-operative.|Facial volume appearance is based on the established Facial Volume Appearance Scale (FVAS). The scale is from 1-3 where 1 indicates no improvement and 3 indicates noticeable improvement of facial volume appearance.|screen, 7-21 days, 3, and 9 months post-operative||||units on FVAS scale||Standard Deviation|Mean
2591718|NCT02267187|Primary|Soft Tissue Volume After Autologous Fat Grafting Using CT Scans.||Assessed at 7-21 days, 3 months, 9 months||||milliliters||Standard Deviation|Mean
2591719|NCT02267135|Secondary|Change From Baseline in Subject Assessment of Scaling (Scalp Only)|"Change from baseline in the Subject Assessment of Scaling (scalp only)~Scale of 0-10 with 10 being the most scaling"|12 weeks|Full Analysis Set|||Scores on a scale||Standard Deviation|Mean
2591720|NCT02267135|Secondary|Change From Baseline in Subject Assessment of Itching|"Change from baseline in the Subject Assessment of Itching~Scale of 0-10 with 10 being the most itchy"|12 weeks|Full Analysis Set|||Scores on a scale||Standard Deviation|Mean
2591721|NCT02267135|Secondary|Change From Baseline in Subject Assessment of Pain|"Change from baseline in the Subject Assessment of Pain~Scale of 0-10 with 10 being the most painful"|12 weeks|Full Analysis Set|||Scores on a scale||Standard Deviation|Mean
2591722|NCT02267135|Secondary|Investigator's Global Assessment Model 2011 (GA Mod 2011) Score of 0 or 1 (Entire Body Including Scalp)|IGA mod 2011 score of 0 or 1 (entire body including scalp); IGA mod 2011 score of 0 means no sign of psoriasis, and IGA mod 2011 score of 1 means almost no psoriasis|12 weeks|Full Analysis Set|||Percent of Participants|||Number
2591723|NCT02267135|Secondary|Psoriasis Area and Severity Index 100 (PASI 100)|PASI 100 response (yes) at Week 12 (non-responder imputation); PASI 100 response means no sign of body psoriasis|12 weeks||||Percent of Participants|||Number
2591724|NCT02267135|Secondary|Psoriasis Area and Severity Index 90 (PASI 90)|PASI 90 response (yes) at Week 12 (non-responder imputation); PASI 90 response means at least a 90% improvement in body psoriasis|12 weeks|Full Analysis Set|||Percent of Participants|||Number
2591725|NCT02267135|Secondary|Psoriasis Area and Severity Index 75 (PASI 75)|PASI 75 response (yes) at Week 12 (non-responder imputation); PASI 75 response means at least a 75% improvement in body psoriasis|12 weeks|Full Analysis Set|||Percent of participants|||Number
2591726|NCT02267135|Secondary|Time to 50% Reduction in PSSI Score up to Week 12|"Time to 50% reduction in PSSI score up to week 12 was estimated for drug arm~The median time to reduction was not estimable for placebo because a 50% reduction in PSSI score was not achieved by enough participants receiving placebo"|12 weeks|Full Analysis Set|||weeks||95% Confidence Interval|Median
2591727|NCT02267135|Secondary|Psoriasis Scalp Severity Index 100 (PSSI 100) Response|PSSI 100 response (yes) at Week 12 (non-responder imputation); PSSI 100 response means no sign of scalp psoriasis|12 weeks|Full Analysis Set|||Percent of Participants|||Number
2591728|NCT02267135|Secondary|Psoriasis Scalp Severity Index 75 (PSSI 75) Response|PSSI 75 response (yes) at Week 12 (non-responder imputation); PSSI 75 response means at least a 75% improvement in scalp psoriasis|12 weeks|Full Analysis Set|||Percent of Participants|||Number
2591729|NCT02267135|Secondary|Change From Baseline in PSSI Score|Change from baseline in Psoriasis Scalp Severity Index (PSSI) score. PSSI score ranges from 0-72 with 72 being severe|12 weeks|Full Analysis Set|||Scores on a scale||Standard Deviation|Mean
2591730|NCT02267135|Secondary|Secondary: Investigator's Global Assessment Model 2011 (IGA Mod 2011) Score of 0 or 1 (Scalp Only)|IGA mod 2011 score of 0 or 1 (scalp only) response at Week 12 (non-responder imputation); IGA mod 2011 score of 0 means no sign of scalp psoriasis, and IGA score of 1 means almost no scalp psoriasis|12 weeks|Full Analysis Set|||Percent of Participants|||Number
2591731|NCT02267135|Primary|Psoriasis Scalp Severity Index 90 (PSSI 90)|"PSSI 90 response (yes) at Week 12; PSSI 90 response means at least a 90% improvement in scalp psoriasis~Percentage of participants with Psoriasis Scalp Severity Index 90 (PSSI 90) response of yes"|12 weeks|Full Analysis Set|||Percent of Participants|||Number
2591732|NCT02267083|Other Pre-specified|Number of Subjects With Tumor Response Per RECIST 1.1|Tumor assessments using contrast enhanced computerized tomography (CT) scan of the Chest/Abdomen/Pelvis were performed to assess overall tumor burden. Response rate (RR), where response is defined as complete response (CR), partial response (PR), or stable disease (SD). Determination of CR or PR requires confirmation at the time of the next tumor assessment. An outcome of SD requires at least one assessment 6 weeks after the initiation of dosing. Progression is defined using RECIST 1.1, as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Assessed during screening, then every 6 weeks for the first 24 weeks on study, and then every 9 weeks for the next 24 weeks for up to 1 year. Subjects will be in the study for up to 1 year, or until disease progression or unacceptable toxicity.|An on-study tumor assessment was done on 19 subjects within the ITT population; 2 subjects died before having a RECIST 1.1 measurement.|||Participants|||Count of Participants
2591733|NCT02267083|Secondary|Number of Subjects Experiencing Adverse Events|Subjects who received at least one dose were included in safety analyses. Adverse events were tabulated by System Organ Class (SOC) and Preferred Term (PT) and coded using MedDRA Version 19.1. Safety and tolerability was determined by frequency, nature, and severity of adverse events and the profile of toxicities.|From the beginning of study treatment and up to 12 months|Subjects who received at least one dose of GPX-150 were included in the safety analyses.|||Participants|||Count of Participants
2591734|NCT02267083|Secondary|Number of Subjects Progression-free at Six Months Per RECIST 1.1|This secondary efficacy endpoint is the progression-free rate (PFR) at 6 months, obtained from the Kaplan-Meier curve for progression-free survival (PFS).|6 months from the beginning of the study treatment|Consists of all subjects in the safety population who had at least one on-study tumor assessment using RECIST 1.1 (19 subjects). One subject withdrew consent before first on-study tumor assessment and two subjects died before first on-study tumor assessment.|||Participants|||Count of Participants
2591735|NCT02267083|Primary|Number of Subjects Progression-free at 12 Months Per RECIST 1.1|The primary efficacy endpoint is the number of patients who were progression-free at 12 months, which is obtained by inversion of the Kaplan-Meier curve for progression-free survival (PFS) at 12 months. Of note, the statistical comparison to historical sarcoma data described in the protocol was not performed due to an enrollment of less than the planned sample size of 30 subjects. Progression is defined using RECIST 1.1, as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|12 months from the beginning of study treatment|Consists of all subjects in the safety population (22 subjects) and who had at least one on-study tumor assessment using RECIST 1.1 (19 subjects). One subject withdrew consist before first on-study tumor assessment and two subjects died before first on-study tumor assessment.|||Participants|||Count of Participants
2591736|NCT02266914|Primary|Cardiac Stiffness With Magnetic Resonance Elastography (MRE)|MRE scans will be performed within 24-48 hours of standard of care cardiac biopsies for patients who have undergone cardiac transplant at The Ohio State University Ross Heart Hospital. Stiffness results from the MRE will be compared to histopathology from the cardiac biopsy to determine if the completely non-invasive MRE can successfully predict transplant rejection.|24-48 hours|Data were not collected due to study termination.||||||
2591737|NCT02266875|Secondary|30 Day All Cause Mortality|Documented mortality at 30 days post discharge|30 days post discharge||||Participants|||Count of Participants
2591738|NCT02266875|Secondary|30 Day Readmission|Documented hospital readmission 30 days post discharge|30 days post discharge||||Participants|||Count of Participants
2591739|NCT02266875|Primary|Change in Patient-Reported Breathing Difficulty - Using Modified Borg Dyspnea Scale|"This is a patient-reported scale to rate the difficulty of breathing. The scale ranges from 0 to 10, wherein 0 indicates no difficulty breathing, and 10 indicates a maximal difficulty in breathing. Patients may report in whole numbers, from 0 to 10, in addition to reporting 0.5, which indicates very, very slight (just noticeable) difficulty in breathing.~A negative change in score indicates a reduction in patient-reported breathing difficulty. The greater the negative change, the better the patient-reported breathing."|Pre-treatment (baseline) vs. 24 hours post-treatment||||units on a scale||Standard Deviation|Mean
2591740|NCT02266810|Secondary|Occlusion/Restenosis (Propel Nova Cohort)|"Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows:~0=Patent~Restenosed/Partially Occluded~Occluded"|Day 30||||percentage of evaluable sinuses|sinus sides|95% Confidence Interval|Number
2591741|NCT02266810|Secondary|Inflammation (Propel Nova Cohort)|The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.|Day 30||||100-mm VAS|sinus sides|Standard Deviation|Mean
2591742|NCT02266810|Secondary|Need for Surgical Interventions (Propel Nova Cohort)|"Need for Surgical Interventions by clinical investigators at Day 30~Need for Surgical Interventions by clinical investigators at Day 30.~Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3.~Adhesions/Scarring was assessed based on a 4-point scale as follows:~0= No visible granulation/scarring in the FSO~Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted)~Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted)~Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)"|Day 30||||percentage of evaluable sinuses|sinus sides||Number
2591743|NCT02266810|Secondary|Need for Post-operative Interventions (Propel Nova Cohort)|"Need for post-operative interventions by clinical investigators at Day 30.~Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale by investigators), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response)."|Day 30||||percentage of evaluable sinuses|sinus sides|95% Confidence Interval|Number
2591744|NCT02266810|Secondary|Occlusion/Restenosis (Propel Mini Cohort)|"Patency of the FSO was assessed by clinical investigators endoscopically on a 3-point grading scale as follows:~0=Patent~Restenosed/Partially Occluded~Occluded"|Day 30||||percentage of evaluable sinuses|sinus sides|95% Confidence Interval|Number
2591745|NCT02266810|Secondary|Inflammation (Propel Mini Cohort)|The degree of inflammation present in the frontal recess/FSO was evaluated by clinical investigators using a 100-mm VAS ranging from 0 defined as no visible inflammation to 100 defined as severe inflammation, involving extensive erythema, edema, or polyposis.|Day 30||||100-mm VAS|sinus sides|Standard Deviation|Mean
2591746|NCT02266810|Secondary|Need for Surgical Interventions (Propel Mini Cohort)|"Need for Surgical Interventions by clinical investigators at Day 30.~Need for surgical interventions was prospectively defined as Adhesion/scarring grades of 2 and 3.~Adhesions/Scarring was assessed based on a 4-point scale as follows:~0= No visible granulation/scarring in the FSO~Minimal amount of granulation, scarring or contraction observed but not obstructing the FSO (intervention not warranted)~Moderate amount of obstructive granulation, scarring or contraction present in the FSO (intervention is warranted)~Significant amount of scarring or contraction causing obstruction of the FSO requiring intervention (likely to compromise patency if not removed)"|Day 30||||percentage of evaluable sinuses|sinus sides||Number
2591747|NCT02266810|Secondary|Need for Post-operative Interventions (Propel Mini Cohort)|"Need for post-operative interventions by clinical investigators at Day 30~Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the FSO (defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response)."|Day 30||||percentage of evaluable sinuses|sinus sides|95% Confidence Interval|Number
2591748|NCT02266810|Primary|Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort)|"The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews.~Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response)."|Day 30|Of the 80 patients who had their endoscopy recorded at day 30 for grading by independent reviewer; 19 patients could not be included in the test due to missing data. Data were considered missing if the independent reviewer could not grade a video on one or both treatment sinus sides.|||percentage sinus requiring intervention||95% Confidence Interval|Number
2591749|NCT02266810|Primary|Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort)|"The reduction in need for post-operative interventions at Day 30, as determined by an independent blinded sinus surgeon based on video-endoscopy reviews.~Need for Post-Operative Intervention is a composite endpoint that includes: surgical intervention required to debride obstructive adhesions or scar tissue formation in the Frontal sinus opening(defined as grade 2 or 3 on the adhesion/scarring scale), and/or oral steroid intervention warranted to resolve recurrent inflammation and polypoid edema in the frontal recess/FSO (Yes/No response)."|Day 30|ITT population|||percent sinuses requiring intervention||95% Confidence Interval|Number
2591750|NCT02266797|Secondary|Examine Whether Intravenous Steroids Affect the Outcomes of Surgery, for Example, Fusion Rates.|The outcomes of surgery will be examined through the 1 year post-operative appointment.|12 months|Data not available due to premature halting of study||||||
2591751|NCT02266797|Secondary|Examine the Impact of Dexamethasone on Radicular Pain.|This will be quantified by the NDI questionnaire and VAS questionnaire for neck pain and arm pain.|12 months|Data not available due to premature halting of study||||||
2591752|NCT02266797|Secondary|Examine the Impact of Dexamethasone on the Development of Postoperative Nausea.|This will be quantified by the visual analogue scale (VAS) questionnaire for nausea and measuring the number of vomiting episodes following surgery.|Immediate post-operatively|Data not available due to premature halting of study||||||
2591753|NCT02266797|Secondary|The Efficacy of Intravenous Steroids on Aspiration Rates of Patients Undergoing Anterior Cervical Spine Surgery.|Aspiration rates will be evaluated by the percentage of patients in each group with post-operative aspiration.|12 months|Data not available due to premature halting of study||||||
2591754|NCT02266797|Primary|The Correlation Between Radiographic Data and the Extent of Dysphagia in Patients.|Soft-tissue swelling will be measured by the anterior cervical soft-tissue shadow width on lateral cervical radiographs. The extent of dysphagia will be evaluated by the dysphagia questionnaires, the swallow evaluation, and the VFSS, if necessary.|12 months|Data not available due to premature halting of study||||||
2591755|NCT02266797|Primary|Intravenous Corticosteroids Effect on Post-operative Dysphagia|The severity of dysphagia will be evaluated by dysphagia questionnaires and a two week postoperative swallow evaluation by a licensed swallowing expert. If recommended by the swallow evaluation, a videofluoroscopic swallow study (VFSS) will be performed to further evaluate the severity of dysphagia.|12 months|Data not available due to premature halting of study||||||
2591756|NCT02266706|Secondary|Number of Participants Who Discontinued the Study Due to an Adverse Event|An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Up to Day 10|The safety population was all enrolled participants who received study drug.|||Participants|||Count of Participants
2591757|NCT02266706|Secondary|Number of Participants With One or More Adverse Events|An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Up to Day 10|The safety population was all enrolled participants who received study drug.|||Participants|||Count of Participants
2591758|NCT02266706|Primary|Plasma Clearance (CL) of Tazobactam|Blood was collected for the determination of CL of tazobactam. CL is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale.|Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6.|The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure.|||L/hour/kg||Geometric Coefficient of Variation|Geometric Mean
2591759|NCT02266706|Primary|Plasma Clearance (CL) of Ceftolozane|Blood was collected for the determination of CL of ceftolozane. CL is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale.|Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6.|The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure.|||L/hour/kg||Geometric Coefficient of Variation|Geometric Mean
2591760|NCT02266706|Primary|Volume of Distribution at Steady State (Vss) of Tazobactam|Blood was collected for the determination of Vss of tazobactam. Vss is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale.|Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6.|The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure.|||L/kg||Geometric Coefficient of Variation|Geometric Mean
2591761|NCT02266706|Primary|Volume of Distribution at Steady State (Vss) of Ceftolozane|Blood was collected for the determination of Vss of ceftolozane. Vss is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale.|Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6.|The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure.|||L/kg||Geometric Coefficient of Variation|Geometric Mean
2591762|NCT02266706|Primary|Elimination Half-life (t1/2) of Tazobactam|Blood was collected for the determination of t1/2 of tazobactam. t1/2 is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale.|Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6.|The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2591763|NCT02266706|Primary|Elimination Half-life (t1/2) of Ceftolozane|Blood was collected for the determination of t1/2 of ceftolozane. t1/2 is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale.|Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6.|The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2591764|NCT02266706|Primary|Area Under the Plasma Concentration-Time Curve (AUC0-inf) of Tazobactam|Blood was collected for the determination of AUC from time zero extrapolated to infinity of tazobactam. AUC0-inf is expressed as geometric least squares mean and confidence interval based on back-transformed least-squares mean and confidence interval from linear mixed-effects model with group fixed effect performed on natural log-transformed values.|Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6.|The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure.|||Hours*μg/mL||95% Confidence Interval|Geometric Least Squares Mean
2591765|NCT02266706|Primary|Area Under the Plasma Concentration-Time Curve (AUC0-inf) of Ceftolozane|Blood was collected for the determination of AUC from time zero extrapolated to infinity of ceftolozane. AUC0-inf is expressed as geometric least squares mean and confidence interval based on back-transformed least-squares mean and confidence interval from linear mixed-effects model with group fixed effect performed on natural log-transformed values.|Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6.|The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure.|||Hours*μg/mL||95% Confidence Interval|Geometric Least Squares Mean
2591766|NCT02266706|Primary|Area Under the Plasma Concentration-Time Curve (AUClast) of Tazobactam|Blood was collected for the determination of AUC from time zero to the last quantifiable concentration of tazobactam. AUC0-last is expressed as geometric least squares mean and confidence interval based on back-transformed least-squares mean and confidence interval from linear mixed-effects model with group fixed effect performed on natural log-transformed values.|Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6.|The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure.|||Hours*μg/mL||95% Confidence Interval|Geometric Least Squares Mean
2591767|NCT02266706|Primary|Area Under the Plasma Concentration-Time Curve (AUClast) of Ceftolozane|Blood was collected for the determination of AUC from time zero to the last quantifiable concentration of ceftolozane. AUC0-last is expressed as geometric least squares mean and confidence interval based on back-transformed least-squares mean and confidence interval from linear mixed-effects model with group fixed effect performed on natural log-transformed values.|Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6.|The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure.|||Hours*μg/mL||95% Confidence Interval|Geometric Least Squares Mean
2591768|NCT02266706|Primary|Time of Last Sampling Point (Tlast) of Tazobactam|Blood was collected for the determination of Tlast of tazobactam.|Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6.|The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure.|||Hours||Full Range|Median
2591769|NCT02266706|Primary|Time of Last Sampling Point (Tlast) of Ceftolozane|Blood was collected for the determination of Tlast of ceftolozane.|Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6.|The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure.|||Hours||Full Range|Median
2591798|NCT02266277|Other Pre-specified|Intervention Patients With Self-reported Influenza Vaccinations Documented in Electronic Health Record (EHR)|We calculated the percent of patients who used the portal or IVR to self-report influenza vaccine completion outside of the medical group, measured on April 1, 2015. We used as our denominator all those patients who received portal messages (10,000) and all those who received IVR calls (15,000).|Months 11-16||||Participants|||Count of Participants
2591770|NCT02266706|Primary|Plasma Concentration at the Last Quantifiable Concentration (Clast) of Tazobactam|Blood was collected for the determination of Clast of tazobactam. Clast is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale.|Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6.|The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2591771|NCT02266706|Primary|Plasma Concentration at the Last Quantifiable Concentration (Clast) of Ceftolozane|Blood was collected for the determination of Clast of ceftolozane. Clast is expressed as geometric mean and percent geometric coefficient of variation, CV% = 100*sqrt(exp(s^2)-1), where s^2 is the observed between-subjects variance on the natural log-scale.|Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6.|The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2591772|NCT02266706|Primary|Time to Maximum Plasma Concentration (Tmax) of Tazobactam|Blood was collected for the determination of Tmax of tazobactam.|Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6.|The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure.|||Hours||Full Range|Median
2591773|NCT02266706|Primary|Time to Maximum Plasma Concentration (Tmax) of Ceftolozane|Blood was collected for the determination of Tmax of ceftolozane.|Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6.|The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure.|||Hours||Full Range|Median
2591774|NCT02266706|Primary|Maximum Plasma Concentration (Cmax) of Tazobactam|Blood was collected for the determination of Cmax of tazobactam. Cmax is expressed as geometric least-squares mean and confidence interval based on back-transformed least-squares mean and confidence interval from linear mixed-effects model with group fixed effect performed on natural log-transformed values.|Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6.|The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure.|||μg/mL||95% Confidence Interval|Geometric Least Squares Mean
2591775|NCT02266706|Primary|Maximum Plasma Concentration (Cmax) of Ceftolozane|Blood was collected for the determination of Cmax of ceftolozane. Cmax is expressed as geometric least-squares mean and confidence interval based on back-transformed least-squares mean and confidence interval from linear mixed-effects model with group fixed effect performed on natural log-transformed values.|Predose and 0.5, 1, 2, 4, and 6 hours after the start of infusion for Cohorts 1 to 4 and 1, 2, and 6 hours after start of infusion for Cohorts 5 and 6.|The pharmacokinetics population included enrolled participants who received a full dose of study drug and had blood samples with quantifiable plasma levels at Cmax and at least 2 time points after Cmax, and were evaluable for the outcome measure.|||μg/mL||95% Confidence Interval|Geometric Least Squares Mean
2591776|NCT02266576|Other Pre-specified|Lipid Bioassays|LDL-cholesterol, HDL-cholesterol, and Triglycerides; performed via fasting participant finger stick with Alere Cholestech LDX POS device|Baseline, 6 months and 12 months|||||||
2591777|NCT02266576|Other Pre-specified|Waist Circumference|In centimeters, measured by trained assessor using standard protocol|Baseline, 6 months and 12 months|||||||
2591778|NCT02266576|Other Pre-specified|Symptoms of Historical Trauma|By patient report using a modified version of the Indigenous People's Survey|Baseline, 6 months and 12 months|||||||
2591779|NCT02266576|Other Pre-specified|Fasting Blood Glucose|Performed via fasting participant finger stick with Alere Cholestech LDX POS device.|Baseline, 6 months and 12 months|||||||
2591780|NCT02266576|Other Pre-specified|Diastolic Blood Pressure|Blood pressure readings are expressed in millimeters of mercury (mmHg). A normal reading would be any blood pressure below 120/80 mm Hg and above 90/60 mm Hg in an adult.|Baseline, 6 months and 12 months|||||||
2591781|NCT02266576|Other Pre-specified|Systolic Blood Pressure|Blood pressure readings are expressed in millimeters of mercury. This unit is abbreviated as mm Hg. A normal reading would be any blood pressure below 120/80 mm Hg and above 90/60 mm Hg in an adult.|Baseline, 6 months and 12 months|||||||
2591782|NCT02266576|Secondary|Change in From Baseline in Empowerment|The Growth and Empowerment Measure (GEM) was developed to measure change in dimensions of empowerment as defined and described by Aboriginal Australians who participated in the Family Well Being programme. The GEM has two components. The 14-item Emotional Empowerment Scale has a range of 12-60, with higher scores corresponding to more ability to feel and show the signs of empowerment . The 12-item Scenarios scale has a range of 12-84, with higher scores corresponding to better emotional empowerment in different scenarios.|Change through month 12, with assessments at baseline, 6 months, and 12 months|One participant from each group was excluded at baseline due to safety concerns; participants with available data at subsequent time points were included in the analysis.|||score on a scale||95% Confidence Interval|Mean
2591783|NCT02266576|Secondary|Change From Baseline in the Center for Epidemiologic Studies - Depression Scale (CES-D) as a Measure of Mental Health Symptoms|The CES-D (Radloff, 1977) is a 20-item, self-report scale designed to assess the presence and severity of depressive symptoms over the past week. The total range is 0-80, with higher scores reflecting more severe depression symptoms.|Change through month 12, with assessments at baseline, 6 months, and 12 months|One participant from each group was excluded at baseline due to safety concerns; participants with available data at subsequent time points were included in the analysis.|||score on a scale||95% Confidence Interval|Mean
2591784|NCT02266576|Secondary|Change From Baseline in Physical Activity Measured in Metabolic Equivalents (MET) Per Week|"MET is a term used to represent the intensity of exercise. A MET is the ratio of the rate of energy expended during an activity to the rate of energy expended at rest. At least 1000 MET minutes per week are needed to lower the risk of disease.~1 minute of light-intensity activities = 1.1 MET to 2.9 METs~1 minute of moderate-intensity activities = 3.0 to 5.9 METs~1 minute of vigorous-intensity activities = 6.0 METs or more"|Change through month 12, with assessments at baseline, 6 months, and 12 months|One participant from each group was excluded at baseline due to safety concerns; participants with available data at subsequent time points were included in the analysis.|||MET minutes per week||95% Confidence Interval|Mean
2591785|NCT02266576|Secondary|Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices|"The FFQ modified to incorporate culturally-relevant food choices (e.g. corn tortillas and frybread) was used. Food items were scored on a scale of 1 to 6 (6 corresponding to the greatest frequency of consumption), and categorized as healthy, unhealthy, and undetermined based on classifications previously determined by Teuful-Shone et al. Healthy foods were those recommended for increased intake (e.g. green leafy salad). Unhealthy foods were recommended for decreased intake (e.g. soft drinks), and all remaining foods were undetermined. Healthy and unhealthy food scores (but not undetermined) were collected for this outcome measure. Scores were summed for a total score. Healthy food choices (6 questions) score range 3-36 (higher scores mean healthier diet). Unhealthy food choices (13 questions) score range: 13-78 (lower scores mean healthier diet)."|Change through month 12, with assessments at baseline, 6 months, and 12 months|One participant from each group was excluded at baseline due to safety concerns; participants with available data at subsequent time points were included in the analysis.|||score on a scale||95% Confidence Interval|Mean
2591786|NCT02266576|Primary|Change From Baseline in the Quality of Life Short Form Survey (SF-12)|SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey to evaluate overall health-related quality of life. Answers are combined, scored and weighted into mental and physical functioning component scales. The scores for each scale range from 0 to 100. A higher value indicates a better quality of life of the patient.|Change through month 12, with assessments at baseline, 6 months, and 12 months|One participant from each group was excluded at baseline due to safety concerns; participants with available data at subsequent time points were included in the analysis.|||score on a scale||95% Confidence Interval|Mean
2591787|NCT02266576|Primary|Change From Baseline in Body Mass Index (BMI) Through Month 12|BMI is measured as weight in kg divided by the square of height in meters.|Change through month 12, with assessments at baseline, 6 months, and 12 months|One participant from each group was excluded at baseline due to safety concerns; participants with available data at subsequent time points were included in the analysis.|||kg/m2||95% Confidence Interval|Mean
2591788|NCT02266472|Secondary|AUC0-infinity of Metformin in Plasma|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2591789|NCT02266472|Secondary|AUC0-infinity of Empagliflozin in Plasma|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2591790|NCT02266472|Primary|Cmax of Metformin in Plasma|Maximum measured concentration of the metformin in plasma|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2591791|NCT02266472|Primary|Cmax of Empagliflozin in Plasma|Maximum measured concentration of the empagliflozin in plasma|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2591792|NCT02266472|Primary|AUC0-tz of Metformin in Plasma|Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2591793|NCT02266472|Primary|AUC0-tz of Empagliflozin in Plasma|Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|Pharmacokinetic set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2591794|NCT02266381|Secondary|Change in Hemoglobin Concentration|Change in hemoglobin concentration is assessed by comparing the preoperative hemoglobin level with 24-hour postoperative hemoglobin level.|within 24 hours after MPCNL||||g/L||Standard Deviation|Mean
2591795|NCT02266381|Secondary|Operation Time|Operation time is defined as the time from puncture to the placement of the nephrostomy tube.|intraoperatively||||min||Standard Deviation|Mean
2591796|NCT02266381|Secondary|Perioperative Complications|Complication is defined as any adverse event occurred intraoperatively or ≤ 30 days postoperatively. Complications included fever, systemic Inflammatory Response Syndrome, septic shock, extravasations, bleeding necessitating transfusion, and sever bleeding necessitating selective renal artery embolization.|intraoperatively or ≤ 30 days postoperatively||||Participants|||Number
2591797|NCT02266381|Primary|Stone Free Rate|Stone-free status is assessed by kidneys-ureter-bladder (KUB) or/ and noncontrast CT at day 1 after MPCNL. A stone-free state is defined as no residual stones of diameter >4 mm.|one day after MPCNL||||Participants|||Number
2591799|NCT02266277|Secondary|Reliant Medical Group (RMG) Patients With Electroinc Health Record (EHR) Documentation of Pneumococcal Vaccine Completion|Using as a denominator those patients identified as being overdue for pneumococcal vaccine at the time of randomization, we calculated frequencies and performed bivariate and multivariate logistic regression analyses, examining the association between randomization group and completion of pneumococcal vaccine. We analyzed portal users and non-portal users separately.|Months 11-16||||Participants|||Count of Participants
2591800|NCT02266277|Primary|Reliant Medical Group (RMG) Patients With Electronic Health Record (EHR) Documentation of Influenza Vaccine Completion for 2014/2015 Season|To determine the impact of our interventions on influenza vaccine completion for the 2014-15 influenza season, we calculated frequencies and performed intention-to-treat bivariate analyses of randomized patients (30,000 patients), assessing whether randomization group was associated vaccine completion. Due to differential rates of vaccination at baseline between portal users and non-users, analyses in these groups were conducted separately. We then performed multivariate logistic regression analyses. We created dummy variables for assignment to the portal message arm (among portal users) and for assignment to the Interactive Voice Recognition (IVR) call arm (among both portal users and, separately, among non-portal users). Including these dummy variables and adjusting for demographic and practice-level covariates, we modeled the odds of receiving an influenza vaccine in the 2014-15 influenza season.|Months 11-16|Using computer-generated random number assignments, we selected 20,000 portal users and 10,000 non portal users (total of 30,000 patients) from the eligible population.|||Participants|||Count of Participants
2591801|NCT02266225|Post-Hoc|Adherence (Excluding Withdrawals)|Adherence is defined as the number of days each week that the participant completes/integrates strength and balance activities into daily tasks. Adherence will be 100% if participants complete the balance and strength activities at least 3 days per week.|6 months|Participants that enrolled in the intervention only|||Participants|||Count of Participants
2591802|NCT02266225|Other Pre-specified|Session Attendance|Number of intervention sessions attended by participation|6 months||||Participants|||Count of Participants
2591803|NCT02266225|Secondary|Change in TFEQ-R21 Score - Emotional Eating Behaviour Subscale|The TFEQ-R21 questionnaire will be administered at Study Visit #1 (baseline), Exercise Session #1, and Study Visit #2 (6 month follow-up) as measures of eating behaviours, including cognitive restraint, uncontrolled eating, and emotional eating. The test-retest reliability of the TFEQ-R21 as a measure of eating behaviour in older adults aged 75 years or older will also be examined to determine consistency and stability of the instrument in the sample population. Subscale scores could range from 0 to 100 with high scores indicating higher emotional eating behaviour.|Baseline, 6 months||||score on a scale||Standard Deviation|Mean
2591804|NCT02266225|Secondary|Change in TFEQ-R21 Score - Uncontrolled Eating Subscale|The TFEQ-R21 questionnaire will be administered at Study Visit #1 (baseline), Exercise Session #1, and Study Visit #2 (6 month follow-up) as measures of eating behaviours, including cognitive restraint, uncontrolled eating, and emotional eating. The test-retest reliability of the TFEQ-R21 as a measure of eating behaviour in older adults aged 75 years or older will also be examined to determine consistency and stability of the instrument in the sample population. Subscale scores could range from 0 to 100 with higher scores indicating higher uncontrolled eating behaviour.|Baseline, 6 months||||score on a scale||Standard Deviation|Mean
2591805|NCT02266225|Secondary|Change in TFEQ-R21 Score- Cognitive Restraint Subscale|The TFEQ-R21 questionnaire will be administered at Study Visit #1 (baseline), Exercise Session #1, and Study Visit #2 (6 month follow-up) as measures of eating behaviours, including cognitive restraint, uncontrolled eating, and emotional eating. The test-retest reliability of the TFEQ-R21 as a measure of eating behaviour in older adults aged 75 years or older will also be examined to determine consistency and stability of the instrument in the sample population. Subscale scores could range from 0 to 100 with higher scores indicating higher cognitive restraint.|Baseline, 6 months||||score on a scale||Standard Deviation|Mean
2591806|NCT02266225|Secondary|Number of Participants Who Provided Feedback on the Barriers and Facilitators to the Implementation of the Exercise Program|Barriers and facilitators to implementation from the perspectives of the participants were identified using in-person or teleconference semi-structured interviews. Semi-structured interviews were conducted in-person with the participants at the 6-month follow-up time-point. The interviews with the participants included open-ended questions to understand their experience and level of satisfaction with the program (reasons for joining the program, observed benefits, areas for improvement, what they liked/disliked, general strategies for physical activity PA).|6 months|Note: 1 participant did not agree to data collection for secondary outcomes|||participants|||Number
2591807|NCT02266225|Secondary|Sum of Scores on Fidelity Rating Forms - Individual and Group Sessions|Fidelity evaluation of video-taped exercise sessions for first and last cohorts in the intervention (all sessions for first and last 4-5 individuals forming a group) will be conducted. A rating of physiotherapist compliance and participant uptake and descriptive feedback will be obtained. Fidelity rating forms (designed in-house by the study team) were filled out for the individual session (e.g., purpose and aims of LiFE program explained) and group sessions (e.g., PT demonstrated the activity to the group and identified situations to embed the activity). Each program criterion was scored out of 2 (0 = not done at all, 1 = done but could be better, 2 = done well) for 34 criteria for the individual session (sum of scores expressed out of 68) and 17 criteria for the group sessions (sum of scores expressed out of 34) with any disagreement resolved via third-party.|6 months|Note: 1 participant did not agree to data collection for secondary outcomes.|||total score on a scale|||Number
2591808|NCT02266225|Secondary|Average Scores on Fidelity Rating Form - Individual and Group Sessions|Fidelity evaluation of video-taped exercise sessions for first and last cohorts in the intervention (all sessions for first and last 4-5 individuals forming a group) will be conducted. A rating of physiotherapist compliance and participant uptake and descriptive feedback will be obtained. Fidelity rating forms (designed in-house by the study team) were filled out for the individual session (e.g., purpose and aims of LiFE program explained) and group sessions (e.g., PT demonstrated the activity to the group and identified situations to embed the activity). Each program criterion was scored out of 2 (0 = not done at all, 1 = done but could be better, 2 = done well) for 34 criteria for the individual session and for 17 criteria for the group sessions with any disagreement resolved via third-party.|6 months|Note: 1 participant did not agree to data collection for secondary outcomes.|||score on a scale||Standard Deviation|Mean
2591809|NCT02266225|Secondary|Number of Participants With Adverse Events or Injuries (Serious or Otherwise)|Participants will be instructed by the research coordinator and physiotherapist to report adverse events or injuries (serious or otherwise) to the research coordinator. Participants will be asked about illnesses or injuries at exercise sessions, follow-up phone calls, and Study Visit #2 (6 month follow-up). Intervention side effects (e.g., falls, fractures) and three types of adverse events will represent secondary outcomes (serious adverse events, adverse events possibly linked to the intervention, and adverse events that lead to study withdrawal or cessation of intervention).|6 months|Note: 1 participant did not agree to data collection for secondary outcomes|||Participants|||Count of Participants
2591810|NCT02266225|Secondary|Number of Participants With Multiple Falls|"Number of participants with multiple falls will be recorded daily on the postage-paid monthly diaries throughout the entire study (along with exercise information). A fall will be defined as an a slip or a trip where the participant loses their balance and part or all of their body lands on the ground, floor or lower level."|6 months|Note: 1 participant did not agree to data collection for secondary outcomes|||Participants|||Count of Participants
2591811|NCT02266225|Secondary|Number of Participants With Falls|"Number of participants with falls will be recorded daily on the postage-paid monthly diaries throughout the entire study (along with exercise information). A fall will be defined as an a slip or a trip where the participant loses their balance and part or all of their body lands on the ground, floor or lower level."|6 months|Note: 1 participant did not agree to data collection for secondary outcomes|||Participants|||Count of Participants
2591812|NCT02266225|Secondary|Number of Falls|"Number of falls will be recorded daily on the postage-paid monthly diaries throughout the entire study (along with exercise information). A fall will be defined as an a slip or a trip where the participant loses their balance and part or all of their body lands on the ground, floor or lower level."|6 months|Note: 1 participant did not agree to data collection for secondary outcomes|||falls|||Number
2591813|NCT02266225|Secondary|Change in Quality of Life- EQ5D Dimensions and VAS Score|Health-related quality of life will be assessed using the EQ5D health questionnaire at Study Visits 1 (Baseline) and 2 (at 6 months) to determine scores for all five dimensions (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and the visual analogue scale (VAS). EQ5D VAS scores range 0-100, with higher scores indicating better overall health.|Baseline, 6 months||||units on a scale||Standard Deviation|Mean
2591814|NCT02266225|Secondary|Change in Physical Performance- Scores on the Short Physical Performance Battery (SPPB)|The SPPB consists of balance tests (side-by-side, semi-tandem, and tandem standing), gait speed during 4-meter walk test, and the average time taken to rise from a chair with arms folded across chest and sit back down (Five-Times-Sit-to-Stand test), sub-scores of which are added to determine a composite score (0-12), with higher scores indicative of better performance. Participants will complete physical performance tests as a measure of balance, mobility, and leg strength at Study Visits 1 (Baseline) and 2 (at 6 months).|Baseline, 6 months|Note: 5 participants partially completed follow-up data collection (we administered questionnaire data over the phone because certain participants were unwilling to come to our centre for data collection) and therefore, SPPB data collection at baseline and 6-month follow-up was reported in 27 participants.|||score on a scale||Standard Deviation|Mean
2591815|NCT02266225|Secondary|Change in Physical Activity- Moderate-to-vigorous Physical Activity (MVPA) (Minutes/Week)|"Participants will wear a physical activity monitor (Actigraph accelerometer) for seven days following Study Visit #1 (baseline) and Study Visit #2 (6 month follow-up) to determine the number of minutes spent sedentary and in light, moderate, and moderate-to-vigorous physical activity.~Participants will complete the IPAQ at Study Visit #1 (baseline) and Study Visit #2 (6 month follow-up) to evaluate changes in self-reported time spent performing physical activity."|Baseline, 6 months|21 participants completed accelerometer data collection at baseline and follow-up|||minutes/week||Standard Deviation|Mean
2591816|NCT02266225|Primary|Adherence (Including Withdrawals)|Adherence is defined as the number of days each week that the participant completes/integrates strength and balance activities into daily tasks. Adherence will be 100% if participants complete the balance and strength activities at least 3 days per week.|6 months|Participants that enrolled in the intervention only|||Participants|||Count of Participants
2591817|NCT02266225|Primary|Retention|Retention is defined as the number of participants retained at Study Visit #1 (6-month follow-up).|6 months|Participants in the intervention|||Participants|||Count of Participants
2591818|NCT02266225|Primary|Feasibility of Recruitment|Feasibility of recruitment is defined as the number of participants recruited (feasibility) over six months.|6 months||||Participants|||Count of Participants
2591819|NCT02266108|Primary|Decreased Sexually Transmitted Infections|decreased reported Sexually Transmitted Infections|6 months||||Participants|||Count of Participants
2591820|NCT02266108|Primary|Number of Participants With Increased Collective Efficacy|improved reported support from other women; increased sense of unity within group, increased sense of belonging|12 months||||Participants|||Count of Participants
2591821|NCT02266108|Primary|Number of Participants With Decreased Economic Vulnerability|Economic vulnerability was measured by asking women about several financial challenges creating urgency in their work. We also measured income.|12 months||||Participants|||Count of Participants
2591822|NCT02265952|Secondary|Percent Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period|Percent change was reported in Apo CIII from baseline (week 0) up to week 16. Apo CIII was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period.|Baseline (Week 0) to Week 16|"n = Number of participants who were evaluable for this endpoint at a given time point."|||Percent Change||Standard Deviation|Mean
2591823|NCT02265952|Secondary|Absolute Change in Apolipoprotein CIII (Apo CIII) From Baseline (Week 0) Over Time in the Main Study Period|Absolute change was reported in Apo CIII from baseline (week 0) up to week 16. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.|Baseline (Week 0) up to Week 16|"n = Number of participants who were evaluable for this endpoint at a given time point."|||mg/dL||Standard Deviation|Mean
2594343|NCT02233738|Secondary|SF-12 Health Survey Mental Summary Score at 3 Months|Mental summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health|3 months||||score on a scale||Standard Deviation|Mean
2591824|NCT02265952|Secondary|Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period|Absolute change was reported in HDL-C, TG and Apo A-1 from baseline (week 26) up to week 214. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)|Baseline (Week 26) up to Week 214|"n = Number of participants who were evaluable for this endpoint at a given time point."|||mg/dL||Standard Deviation|Mean
2591825|NCT02265952|Secondary|Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period|Percent change was reported in HDL-C, TG and Apo A-1 from baseline (week 26) up to week 214. HDL-C, TG and Apo A-1 were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)|Baseline (Week 26) up to Week 214|"n = Number of participants who were evaluable for this endpoint at a given time point."|||Percent change||Standard Deviation|Mean
2591826|NCT02265952|Secondary|Percent Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period|Percent change was reported in HDL-C, TG, and Apo A-1 from baseline (week 0) up to week 26. HDL-C, TG, and Apo A-1 were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.|Baseline (Week 0) up to Week 26|"n = Number of participants who were evaluable for this endpoint at a given time point."|||Percent Change||Standard Deviation|Mean
2591827|NCT02265952|Secondary|Absolute Change in High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), and Apolipoprotein A-1 (Apo A-1) From Baseline (Week 0) Over Time in the Main Study Period|Absolute change was reported in HDL-C, TG, and Apo A-1 from baseline (week 0) up to week 26. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period.|Baseline (Week 0) up to Week 26|"n = Number of participants who were evaluable for this endpoint at a given time point."|||mg/dL||Standard Deviation|Mean
2591828|NCT02265952|Secondary|Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 26) in the Open Label Extension (OLE) Period|Percentage of participants who achieved reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 50% from baseline (week 26) in the OLE period was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.|Baseline (Week 26) up to Week 214||||Percentage|||Number
2591829|NCT02265952|Secondary|Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 50% From Baseline (Week 0) in the Main Study Period|Percentage of participants who achieved a reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 50% from baseline (week 0) to week 26 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.|Baseline (Week 0) to Week 26||||Percentage of participants|||Number
2591830|NCT02265952|Secondary|Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 26) in the Open Label Extension (OLE) Period|Percentage of participants who achieved a reduction in low-density lipoprotein cholesterol (LDL-C) of ≥ 25% from baseline (week 26) to week 214 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.|Baseline (Week 26) to Week 214||||Percentage of participants|||Number
2591831|NCT02265952|Secondary|Percentage of Participants Who Achieved Reduction in Low-Density Lipoprotein Cholesterol (LDL-C) of ≥ 25% From Baseline (Week 0) in the Main Study Period|Percentage of participants who achieved reduction in low-density lipoprotein cholesterol (LDL-C) of greater than or equal to (≥) 25 percent (%) from baseline in the main study period was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.|Baseline (Week 0) up to Week 26||||Percentage of participants|||Number
2591832|NCT02265952|Secondary|Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period|Percent change was reported in Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 26) up to week 214 in OLE Period. Apo B, Non-HDL-C, Total-C, and Lp(a) were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)|Baseline (Week 26) up to Week 214|"n = Number of participants who were evaluable for this endpoint at a given time point."|||Percent change||Standard Deviation|Mean
2591833|NCT02265952|Secondary|Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period|Absolute changein Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline to week 214 in open label extension (OLE) period. The efficacy analysis set included all participants in the SAF who had baseline and at least one post-baseline measure of the lipid panel in the main study period. (ET = Early Termination; EOS = End of Study)|Baseline (Week 26) up to Week 214|"n = Number of participants who were evaluable for this endpoint at a given time point."|||mg/dL||Standard Deviation|Mean
2591834|NCT02265952|Secondary|Percent Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period|Percent change was reported for Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 0) up to week 26. Apo B, Non-HDL-C, Total-C, and Lp(a) were measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.|Baseline (Week 0) up to Week 26|"n = Number of participants who were evaluable for this endpoint at a given time point."|||Percent Change||Standard Deviation|Mean
2605751|NCT02107014|Primary|Change in IL-13 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2591835|NCT02265952|Secondary|Absolute Change in Apolipoprotein (Apo B), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Total Cholesterol (Total-C), and Lipoprotein(a) (Lp[a]) From Baseline (Week 0) up to Week 26 in the Main Study Period|Absolute change was reported for Apo B, Non-HDL-C, Total-C, and Lp(a) from baseline (week 0) up to Week 26. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.|Baseline (Week 0) up to Week 26|"n = Number of participants who were evaluable for this endpoint at a given time point."|||mg/dL||Standard Deviation|Mean
2591836|NCT02265952|Secondary|Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period|Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 26) to week 214 in the OLE period. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had at least 1 post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)|Baseline (Week 26) up to Week 214|"n = Number of participants who were evaluable for this endpoint at a given time point."|||Percent Change||Standard Deviation|Mean
2591837|NCT02265952|Secondary|Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 26) to Week 214 in the Open Label Extension (OLE) Period|Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline (week 26) up to week 214 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period. (ET= Early Termination; EOS = End of Study)|Baseline (Week 26) up to Week 214|"n = Number of participants who were evaluable for this endpoint at a given time point."|||mg/dL||Standard Deviation|Mean
2591838|NCT02265952|Secondary|Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period|Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 26. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.|Baseline (Week 0) up to Week 26|"n = Number of participants who were evaluable for this endpoint at a given time point."|||Percent Change||Standard Deviation|Mean
2591839|NCT02265952|Secondary|Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) Over Time in the Main Study Period|Absolute change was reported in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 26. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.|Baseline (Week 0) up to Week 26|"n = Number of participants who were evaluable for this endpoint at a given time point."|||mg/dL||Standard Deviation|Mean
2591840|NCT02265952|Secondary|Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period|Percent change was reported in low-density lipoprotein cholesterol (LDL-C) from week 2 to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.|Week 2 to Week 4||||Percent Change||Standard Deviation|Mean
2591841|NCT02265952|Secondary|Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Week 2 to Week 4 in the Main Study Period|Absolute change in low-density lipoprotein cholesterol (LDL-C) from week 2 to week 4 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.|Week 2 to Week 4||||Milligram per Deciliter (mg/dL)||Standard Deviation|Mean
2591842|NCT02265952|Primary|Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period|Percent change was reported for low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4. LDL-C was measured using conventional units mg/dL. The efficacy analysis set included all participants in the safety analysis set (SAF) who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.|Baseline (Week 0) up to Week 4||||Percent Change||Standard Deviation|Mean
2591843|NCT02265952|Secondary|Absolute Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline (Week 0) to Week 4 in the Main Study Period|Absolute change in low-density lipoprotein cholesterol (LDL-C) from baseline (week 0) up to week 4 was reported. The efficacy analysis set included all participants in the SAF who had baseline and at least 1 post-baseline measure of the lipid panel in the main study period.|Baseline (Week 0) up to Week 4||||mg/dL||Standard Deviation|Mean
2591844|NCT02265848|Other Pre-specified|Preferability|At the conclusion of the study, subjects were asked to report which spinal cord stimulation modes they preferred. Subjects were presented with two boxes (1000 Hz. stimulation and Standard stimulation) and asked to check one.|End of treatment visit on visit 4|All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.|||participants|||Number
2591845|NCT02265848|Secondary|Patient's Global Impression of Change (PGIC)|PGIC is a 7-point scale that requires study subjects to rate the severity of their illness or medical condition after a specific treatment. 1: No change, 2: Almost the same, 3: A little better, 4: Somewhat better, 5: Moderately better, 6: Better, 7: A great deal better. Study subjects were asked to report their impression of changes at baseline visit, visit 2 through 4.|Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)|All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.|||units on a scale||Full Range|Mean
2591846|NCT02265848|Secondary|Oswestry Disability Index Questionnaire (ODI).|ODI is a outcome metrics that is design to assess the severity of disability based on 10 activity categories. ODI is based on 0 to 100% scale, where larger percentage implies worse disability. (There are 5 categories: 0-20%: Minimal disability, 21-40%: Moderate disability, 41-60%: Severe disability, 61-80%: Crippled. 81-100%: Either bed bound or exaggerating symptoms). ODI were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation.|Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)|All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.|||units on a scale||Full Range|Mean
2591847|NCT02265848|Primary|Numeric Pain Rating Scale (NPRS)|Digital pain rating system that scores patient's subjective pain rating from 0 to 10; with greater number indicating progressively worsening pain. NPRS were measured at baseline (visit1), and at each follow ups visits at visit 2, 3 and 4. Visit 2 and 4 captured post treatment (either 1000 Hz or standard stimulation depending on the randomization) results, and visit 3 captured NPRS after the wash off from the spinal cord stimulation.|Baseline (visit 1), and at each follow up visits (visits 2, 3, and 4)|All study subjects were implanted with Boston Scientific's Precision Plus spinal cord stimulation system for treatment of chronic axial pain.|||units on a scale||Full Range|Mean
2591848|NCT02265796|Secondary|Ischemia Driven Revascularization or Hospitalization|Number of participants who reported adverse events for ischemia driven revascularization or hospitalization|4 month|the incidence of ischemia driven hospitalization or catheterization was assessed for all subjects.|||Participants|||Count of Participants
2591849|NCT02265796|Secondary|Subjective Well Being|overall feeling of well being determined from rating of excellent, good, fair or poor at baseline compared to same at month 4|Compare from baseline to month 4||||Participants|||Count of Participants
2591850|NCT02265796|Primary|Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks|"The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life.Each of the 5 dimensions are scored by assigning eachresponse an ordinal value, beginning with 1 for the response that implies the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range1 / 3 Seattle Angina Questionnaire (SAQ)of the scale and multiplying by 100. No overall scale score is generated.~Factors and Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).~."|Change in baseline to 16 weeks|by intention to treat, 46 subjects had baseline and follow up SAQ data completed at 16 weeks|||units on a scale||Standard Deviation|Mean
2591851|NCT02265783|Primary|"Report the Time Until the Device Posts Sensor Off After the Sensor is Removed"|A series of sensor-off events were collected from subjects in the study using marketed, off-the-shelf sensors. Each event was marked as pass if event duration (Timeend - Timestart) was less than or equal to 60 seconds; otherwise, the event was marked as greater than or equal to 60 seconds. The acceptance criteria is if 90% of the time the product posts Sensor Off, or any equal or higher priority alarm, within 60 seconds after sensor is removed.|1 minute per event, multiple events per subject. Total duration up to 1 hour|20 subjects participated. There were errors with the data collection device for one subject and the data was unusable.|||Percent||95% Confidence Interval|Mean
2591852|NCT02265744|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) on Day 85 and Day 169|Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 100 millimeter (mm) visual analog scale (VAS), where 0 mm = very good and 100 mm = very bad.|At baseline, Day 85 and Day 169|All randomized and treated participants|||Score||Standard Deviation|Mean
2591853|NCT02265744|Secondary|Change From Baseline in the SLEDAI-2K Score of SLE Activity on Day 85 and Day 169|Systemic Lupus Erythematosus Disease Activity Index, SLEDAI; Version 2000, also known as SLEDAI-2K. The SLEDAI-2K score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.|At baseline, Day 85 and Day 169|All randomized and treated participants|||Score||Standard Deviation|Mean
2591854|NCT02265744|Secondary|Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS|QUALITATIVE URINE CHEMISTRY: BLOOD, URINE N/A H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 GLUCOSE, URINE N/A H >= 1 IF PRE-RX IS MISSING OR >= 1 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 PROTEIN, URINE UNKNOWN H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 URINALYSIS II URINE WBC + RBC ; RBC, URINE HPF H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 2 OR >= 4 IF PRE-RX >= 2 WBC, URINE HPF H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 2 OR >= 4 IF PRE-RX >= 2|Up to 42 days post last dose of study medication in short-term or long-term extension period|All treated participants|||Participants|||Number
2591855|NCT02265744|Secondary|Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : IMMUNOLOGY|IMMUNE ACTIVATION MARKERS:C-REACTIVE PROTEIN (CRP) CRP MG/L H > 1.5×ULN; CRP, HIGH SENSITIVITY MG/L H > 1.5×ULN;|Up to 42 days post last dose of study medication in short-term or long-term extension period|All treated participants|||Participants|||Number
2591856|NCT02265744|Secondary|Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 3|OTHER CHEMISTRY TESTING CARDIAC TESTS: CREATINE KINASE (CK) CK U/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN; TROPONIN-I, CARDIAC SPECIFIC UG/L H > ULN; METABOLITE TESTS:URIC ACID URIC MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; CHEM TEST, MULTI INDICATIONS : LACTATE DEHYDROGENASE (LD) LD U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN|Up to 42 days post last dose of study medication in short-term or long-term extension period|All treated participants|||Participants|||Number
2591857|NCT02265744|Secondary|Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2|OTHER CHEMISTRY TESTING LIPID TESTS: CHOLESTEROL, TOTAL (TC) MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN TRIGLYCERIDES, FASTING MMOL/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN PANCREATIC TESTS: AMYLASE, TOTAL U/L H > 1.5×ULN; LIPASE, TOTAL (TURBIDIMETRIC ASSAY) U/L H > 1.5×ULN; LIPASE, TOTAL (COLORIMETRIC ASSAY) U/L H > 1.5×ULN; ENDOCRINE TESTS:CORTISOL, AM NMOL/L L < 138 THYROID STIMULATING HORMONE (TSH) TSH MU/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 2×PRE-RX IF PRE-RX > ULN|Up to 42 days post last dose of study medication in short-term or long-term extension period|All treated participants|||Participants|||Number
2591881|NCT02265744|Secondary|Mean Change From Baseline in CLASI Score at Day 85 and Day 169|Mean change from baseline, CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index. Scores can range from 0 to 70 with higher scores denoting greater disease activity or damage.|At Day 85 and Day 169|All Randomized and Treated Subjects|||Scores on a scale||Standard Deviation|Mean
2591858|NCT02265744|Secondary|Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 1|GLUCOSE TESTS:GLUCOSE, FASTING SERUM MMOL/L H > 1.3×ULN IF PRE-RX IS MISSING OR > 1.3×ULN IF PRE-RX <= ULN OR > 2×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN GLUCOSE, FASTING SERUM MMOL/L L < 0.8×LLN IF PRE-RX IS MISSING OR < 0.8×LLN IF PRE-RX >= LLN OR < 0.8×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; PROTEIN TESTS:ALBUMIN G/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN PROTEIN, TOTAL G/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN PROTEIN, TOTAL G/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN|Up to 42 days post last dose of study medication in short-term or long-term extension period|All treated participants|||Participants|||Number
2591859|NCT02265744|Secondary|Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 3|SODIUM, SERUM MMOL/L H > 1.05×ULN IF PRE-RX IS MISSING OR > 1.05×ULN IF PRE-RX <= ULN OR > 1.05×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN SODIUM, SERUM MMOL/L L < 0.95×LLN IF PRE-RX IS MISSING OR < 0.95×LLN IF PRE-RX >= LLN OR < 0.95×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN PHOSPHORUS, INORGANIC PHOS MMOL/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN PHOSPHORUS, INORGANIC PHOS MMOL/L L < 0.85×LLN IF PRE-RX IS MISSING OR < 0.85×LLN IF PRE-RX >=LLN OR < 0.85×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN|Up to 42 days post last dose of study medication in short-term or long-term extension period|All treated participants|||Participants|||Number
2591860|NCT02265744|Secondary|Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 2|BICARBONATE MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; BICARBONATE MMOL/L L < 0.8×LLN IF PRE-RX IS MISSING OR < 0.8×LLN IF PRE-RX >= LLN OR < 0.8×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; POTASSIUM, SERUM MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; POTASSIUM, SERUM MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; MAGNESIUM, SERUM MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN MAGNESIUM, SERUM MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN|Up to 42 days post last dose of study medication in short-term or long-term extension period|All treated participants|||Participants|||Number
2591861|NCT02265744|Secondary|Number of Participants Clinically Significant Abnormalities in General Laboratory Tests ELECTROLYTES 1|CALCIUM, TOTAL MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; CALCIUM, TOTAL MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; CHLORIDE, SERUM MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; CHLORIDE, SERUM MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN;|Up to 42 days post last dose of study medication in short-term or long-term extension period|All treated participants|||Participants|||Number
2591862|NCT02265744|Secondary|Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: KIDNEY FUNCTION TESTS|KIDNEY FUNCTION TESTS:BLOOD UREA NITROGEN MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN CREATININE UMOL/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 1.33×PRE-RX IF PRE-RX > ULN GLOMERULAR FILTRATION RATE, CALC. ML/S/M*2 L < 0.8×PRE-RX; UREA UREA MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN|Up to 42 days post last dose of study medication in short-term or long-term extension period|All treated participants|||Participants|||Number
2591863|NCT02265744|Secondary|Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS|LIVER FUNCTION TESTS:ALKALINE PHOSPHATASE (ALP) ALP U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; BILIRUBIN, DIRECT UMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN G-GLUTAMYL TRANSFERASE (GGT) GGT U/L H > 1.15×ULN IF PRE-RX IS MISSING OR > 1.15×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN BILIRUBIN, TOTAL UMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN|Up to 42 days post last dose of study medication in short-term or long-term extension period|All treated participants|||Participants|||Number
2591864|NCT02265744|Secondary|Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II|WBC DIFFERENTIAL COUNT: BASOPHILS (ABSOLUTE) X10*9 C/L H > 0.4; BLASTS (ABSOLUTE) X10*9 C/L H > 0; EOSINOPHILS (ABSOLUTE) EOSA X10*9 C/L H > 0.75; LYMPHOCYTES (ABSOLUTE) X10*9 C/L H > 7.5; LYMPHOCYTES (ABSOLUTE) X10*9 C/L L < 0.75; MONOCYTES (ABSOLUTE) X10*9 C/L H > 2; NEUTROPHILS (ABSOLUTE) X10*9 C/L L < 1.5 IF PRE-RX IS MISSING OR < 1.5 IF PRE-RX >= 1.5 OR < 0.85×PRE-RX IF PRE-RX < 1.5; COAGULATION activated Partial thromboplastin time (APTT) SEC H > 1.5×ULN; INTL NORMALIZED RATIO (INR) INR FRACTION H > 1.5×ULN PROTHROMBIN TIME (PT) PT SEC H > 1.5×ULN|Up to 42 days post last dose of study medication in short-term or long-term extension period|All treated participants|||Participants|||Number
2591865|NCT02265744|Secondary|Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I|HEMATOLOGY I: ERYTHROCYTE/PLATELET ATTRIBUTES HEMOGLOBIN G/L L < 0.85×PRE-RX; HEMATOCRIT VOL L < 0.85×PRE-RX; PLATELET COUNT X10*9 C/L H > 1.5×ULN (ULN = Upper Limit of Normal) IF PRE-RX IS MISSING OR > 1.5×ULN PLATELET COUNT X10*9 C/L L < 0.85×LLN (LLN = Lower Limit of Normal) IF PRE-RX IS MISSING OR < 0.85×LLN IF PRE-RX >= LLN OR < 0.85×PRE-RX IF PRE-RX < LLN; ERYTHROCYTES RBC X10*12 C/L L < 0.85×PRE-RX HEMATOLOGY II QUANTITATIVE WBC : LEUKOCYTES X10*9 C/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF LLN <= PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; LEUKOCYTES WBC X10*9 C/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF LLN <= PRE-RX <= ULN OR < 0.85×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN|Up to 42 days post last dose of study medication in short-term or long-term extension period|All treated participants|||Participants|||Number
2591866|NCT02265744|Secondary|Percentage of Participants With BMS-931699 Induced Antibody Response Over Time Point Specified|Immunogenicity defined as positive for anti-drug antibodies post-baseline measurement if baseline missing or negative. If baseline is positive, then immunogenicity is defined as a positive post-baseline measurement with titer value 4 times greater than baseline. (A) all subjects with a laboratory reported positive antibody responses to BMS-931699 during the short-term double-blind treatment period are included. Overall: At least one positive sample relative to baseline during short-term double-blind and follow-up period.|Day 169|All Treated participants with at Least One Post-Treatment Immunogenicity Assessment Who Developed Laboratory Reported Positive Antibody Responses to BMS-931699|||Percentage of participants|||Number
2591867|NCT02265744|Secondary|Short Term: Receptor Occupancy Over Time|Percent CD4+ Receptor Occupancy and percent CD8+ Receptor Occupancy|At Day 85 and Day 169|All Treated participants with at Least One Post-Treatment Biomarker Measurement|||Percentage||Standard Deviation|Mean
2591868|NCT02265744|Secondary|Serum Biomarkers: Anti-Nuclear Antibodies (ANA)|Serum biomarkers C3, C4, anti-double-stranded deoxyribonucleic acid (anti-dsDNA), anti-nuclear antibody (ANA) and other autoantibodies were measured from blood serum samples collected on Day 85 and Day 169. No anti-dsDNA data was available for this report|At Day 85 and Day 169|All Treated participants with at Least One Post-Treatment Biomarker Measurement|||Percentage|||Number
2591869|NCT02265744|Secondary|Serum Biomarkers C3, C4|Serum biomarkers C3, C4, anti-double-stranded deoxyribonucleic acid (anti-dsDNA), anti-nuclear antibody (ANA) and other autoantibodies were measured from blood serum samples collected on Day 85 and Day 169|At Day 85 and Day 169|All Treated participants with at Least One Post-Treatment Biomarker Measurement|||g/L||Standard Deviation|Mean
2591870|NCT02265744|Secondary|Ctrough: Trough Level Serum Concentration of BMS-931699 at Time Point Specified|Pharmacokinetics of BMS-931699 derived from serum concentration versus time data; Ctrough = Trough level serum concentration of BMS-931699 at time point specified Pharmacokinetic Population: defined as all subjects who receive any study medication and have any available concentration-time data.|Day 169|Pharmacokinetic population|||ng/mL||Standard Deviation|Mean
2591871|NCT02265744|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities|QTc (corrected QT) Fridericia, PR Interval, QRS Interval and Change from baseline in QTCF|Up to 42 days post last dose of short-term double-blind study medication or up to the day prior to the start of long-term extension period, whichever is earlier.|All treated participants|||Participants|||Count of Participants
2591872|NCT02265744|Secondary|Percentage of Participants With Clinically Significant Changes in Vital Signs: Temperature|TEMPERATURE (TEMP) (C) TEMP > 38.3 OR TEMP CHANGE FROM BASELINE > 1.6|At Day 85 and Day 169|All Treated participants|||Percentage of participants|||Number
2591873|NCT02265744|Secondary|Percentage of Participants With Clinically Significant Changes in Vital Signs: Respiration Rate|RESPIRATION RATE (RESP) (PER MIN) RESP > 16 OR RESP CHANGE FROM BASELINE > 10|At Day 85 and Day 169|All Treated participants|||Percentage of participants|||Number
2591874|NCT02265744|Secondary|Percentage of Participants With Clinically Significant Changes in Vital Signs: Systolic and Diastolic Blood Pressure|SYSTOLIC BLOOD PRESSURE (SYSBP) (MMHG); SYSBP > 140 AND CHANGE FROM BASELINE > 20 OR SYSBP < 90 AND CHANGE FROM BASELINE < -20; DIASTOLIC BLOOD PRESSURE (DIABP) > 90 AND CHANGE FROM BASELINE > 10 OR DIABP < 55 AND CHANGE FROM BASELINE < -10;|At Day 85 and Day 169|All Treated participants|||Percentage of participants|||Number
2591875|NCT02265744|Secondary|Percentage of Participants With Clinically Significant Changes in Vital Signs:Heart Rate|HEART RATE (HR) Beats per min (BPM): HR > 100 AND CHANGE FROM BASELINE > 30 OR HR < 55 AND CHANGE FROM BASELINE < -15|At Day 85 and Day 169|All Treated participants|||Percentage of participants|||Number
2591876|NCT02265744|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest|Although there are no identified risks for BMS-931699, BMS has developed a list of events of special interest for the BMS-931699 program based on the known biologic class effects, the mechanism of action of BMS-931699, overall potential consequences of mmunosuppression, and preliminary data from unblinded clinical trials. Event categories of special interest for this study may include, but are not limited to: Infections, Autoimmunity, Malignancies, Injection-related reactions|On or after the first dose date of short-term study medication and up to 42 days post last short-term dose date or up to the day prior to the first dose of long-term extension period, whichever is earlier|All treated subjects|||Participants|||Count of Participants
2591877|NCT02265744|Secondary|Cumulative Corticosteroid and Immunosuppressant Use|Percent of participants requiring use of corticosteroids and mmunosuppressants use over time|Up to one day prior to the first dose of long-term extension period or up to 42 days post last short-term dose date, which ever is earlier|All randomized and treated participants|||Percentage of participants|||Number
2591878|NCT02265744|Secondary|Change From Baseline in BILAG-2004 Score of Systemic Lupus Erythematosus (SLE) Activity on Day 85 and Day 169|Overall British Isles Lupus Assessment Group-2004 score, BILAG Scores: A=Severe disease activity, B=Moderate disease activity, C=Mild disease, D=Inactive disease but previously affected, E=System never involved.The categories are converted to a numeric score (A=9, B=3, C=1, D=0, E=0) and treated as a continuous variable. Higher score= more severe disease activity.|At baseline, Day 85 and Day 169|All randomized and treated participants|||Score||Standard Deviation|Mean
2591879|NCT02265744|Secondary|Change From Baseline in Arthritis, as Assessed by American College of Rheumatology (ACR) 28-joint Count of Tender and Swollen Joints on Day 85 and Day 169|Mean Change from Baseline Over Time; Measured by Disease Activity Score 28: A single score on a continuous scale (0-9.4). The level of RA disease activity can be interpreted as low (DAS28 <=3.2),moderate (3.2 < DAS28 <=5.1), or as high disease activity (DAS28 > 5.1)|At baseline, Day 85 and Day 169|All Randomized and Treated Participants|||Scores on a scale||Standard Deviation|Mean
2591880|NCT02265744|Secondary|Percentage of Participants With an Improvement of >4 or a Decrease of >50% From Baseline in Their Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Score|Mean change from baseline, CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index. Scores can range from 0 to 70 with higher scores denoting greater disease activity or damage.|At Day 85 and Day 169|All randomized and treated participants|||Percentage of participants||90% Confidence Interval|Number
2594344|NCT02233738|Secondary|SF-12 Health Survey Mental Summary Score at 1 Month|Mental summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health|1 month||||score on a scale||Standard Deviation|Mean
2591882|NCT02265744|Secondary|Percentage of Participants With BICLA Response (BICLA Response Rate) at Day 85|"BICLA is defined as: British Isle Lupus Assessment Group improvement, defined as BILAG As at Baseline improved to B/C/D, and BILAG Bs at baseline improved to C/D, and no BILAG worsening in other BILAG organ systems such that there are no new BILAG As or greater than 1 new BILAG B; and no worsening in the SLEDAI-2K total score compared to Baseline (defined as no increase in SLEDAI total score); and no worsening in the physician's global assessment (MDGA) of disease activity (no worsening is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline; No changes in concomitant medications according to the following criteria: No increase of or addition of a new immunosuppressant agent (azathioprine,mycophenolic acid/mycophenolate mofetil, methotrexate, anti-malarial, leflunomide) over baseline levels; No increase in corticosteroid dose above baseline level outside of those allowed per protocol."|At Day 85|All Randomized and Treated Participants|||Percentage of participants||90% Confidence Interval|Number
2591883|NCT02265744|Secondary|Percentage of Participants Who Meet Response Criteria for the SLE Responder Index: SRI(4), SRI(5) and SRI(6) at Day 85|"SRI is the Systemic Lupus Erythematosus Responder Index. An SRI(4) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 4 points AND (a)no worsening in the physician's global assessment (MDGA) of disease activity (no worsening is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline) AND (b) no new BILAG-2004 Index A organ system score AND (c)no more than one new or worsening BILAG-2004 Index B organ system scores.~An SRI(5) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 5 points AND (a) AND (b) AND (c).~An SRI(6) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 6 points AND (a) AND (b) AND (c) The outcomes are better in increasing order from SRI(4) to SRI(5) to SRI(6)"|At Day 85|All Randomized and Treated participants|||Percentage of participants||90% Confidence Interval|Number
2591884|NCT02265744|Secondary|Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169|"SRI is the Systemic Lupus Erythematosus Responder Index. An SRI(4) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 4 points AND (a)no worsening in the physician's global assessment (MDGA) of disease activity (no worsening is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline) AND (b) no new BILAG-2004 Index A organ system score AND (c)no more than one new or worsening BILAG-2004 Index B organ system scores.~An SRI(5) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 5 points AND (a) AND (b) AND (c).~An SRI(6) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 6 points AND (a) AND (b) AND (c) The outcomes are better in increasing order from SRI(4) to SRI(5) to SRI(6)"|At Day 169|All randomized and treated participants|||Percentage of participants||90% Confidence Interval|Number
2591885|NCT02265744|Primary|Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169|"The British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) is a measure of systemic lupus erythematosus (SLE) response. BICLA is defined as: British Isle Lupus Assessment Group improvement, defined as BILAG As at Baseline improved to B/C/D, and BILAG Bs at baseline improved to C/D, and no BILAG worsening in other BILAG organ systems such that there are no new BILAG As or greater than 1 new BILAG B; and no worsening in the SLEDAI-2K total score compared to Baseline (defined as no increase in SLEDAI total score); and no worsening in the physician's global assessment (MDGA) of disease activity (no worsening is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline."|At Day 169|All Randomized and Treated participants|||Percentage of participants||90% Confidence Interval|Number
2591886|NCT02265705|Secondary|Mean Worst Pain NRS in the 7 Days Prior to Week 12|"Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents no pain and 10 represents pain as bad as you can imagine. Participants reported their worst joint pain in daily paper diaries. The average value across the 7 days preceding each visit was calculated."|Week 12|All randomized participants who received at least one dose of study drug and had evaluable score at Week 12.|||units on a scale||Standard Deviation|Mean
2591887|NCT02265705|Secondary|Mean Worst Tiredness Numeric Rating Scale (NRS) in the 7 Days Prior to Week 12|"Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents no tiredness and 10 represents as bad as you can imagine. Participants reported their worst tiredness in paper diaries. The average value across the 7 days preceding each visit is calculated."|Week 12|All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.|||units on a scale||Standard Deviation|Mean
2591888|NCT02265705|Secondary|Mean Severity of Morning Joint Stiffness in the 7 Days Prior to Week 12|"Participants rated the severity of their morning joint stiffness by selecting a number from 0 to 10 that best described their overall level of morning joint stiffness from the time they woke up, where 0 represents no joint stiffness and 10 represents joint stiffness as bad as you can imagine. Participants reported their severity daily in paper diaries. The average value across the 7 days preceding each visit was calculated."|Week 12|All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.|||units on a scale||Standard Deviation|Mean
2591889|NCT02265705|Secondary|Median Duration of Morning Joint Stiffness in the 7 Days Prior to Week 12|Participants recorded the duration of their morning joint stiffness (MJS) in hours and minutes into paper diaries daily. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit was calculated. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.|Week 12|All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.|||minutes||95% Confidence Interval|Median
2591906|NCT02265510|Secondary|Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793|Cmax is defined as the maximum observed plasma concentration measured at Day 1.|Cycle 1, Day 1|Data was not collected as no participants were enrolled in Part 2 of the study.||||||
2591967|NCT02263326|Primary|Proportion of Participants With Treatment Failure|Proportion of participants with treatment failure (defined as virologic failure (HIV RNA >50 copies/mL), loss to follow-up, or treatment discontinuation) between those who switch to DTG + lamivudine and those who continue their current ART regimen|24 weeks||||proportion of participants|||Number
2591890|NCT02265705|Secondary|Proportion of Participants Achieving a Simplified Disease Activity Index (SDAI) Score < or Equal to 3.3|SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Participant's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.|Week 12|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2591891|NCT02265705|Secondary|Change From Baseline to Week 12 in Disease Activity Score Modified to Include the 28 Diarthroidal Joint Count (DAS28)-High Sensitivity C-Reactive Protein (hsCRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.|Baseline, Week 12|All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.|||units on a scale||Standard Deviation|Mean
2591892|NCT02265705|Secondary|Change From Baseline to Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug and had an evaluable score at Week 12.|||units on a scale||Standard Deviation|Mean
2591893|NCT02265705|Primary|Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20)|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100.|Week 12|All randomized participants who received at least one dose of the study drug.|||percentage of participants|||Number
2591894|NCT02265510|Secondary|Phase 1a, Part 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793|AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.|Cycle 2, Day 1|Data was not collected as no participants were enrolled in Part 2 of the study||||||
2591895|NCT02265510|Secondary|Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time|AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.|Cycle 2, Day 1|Data was not collected as no participants were enrolled in Part 2 of the study.||||||
2591896|NCT02265510|Secondary|Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793|Tmax is the time to maximum (peak) observed plasma drug concentration.|Cycle 2, Day 1|Data was not collected as no participants were enrolled in Part 2 of the study.||||||
2591897|NCT02265510|Secondary|Phase 1a, Part 2: Cmin: Minimum Observed Plasma Concentration Over the Dose Interval|Cmin is defined as the minimal observed plasma concentration measured at cycle 2 Day 1|Cycle 2, Day 1|Data was not collected as no participants were enrolled in Part 2 of the study.||||||
2591898|NCT02265510|Secondary|Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793|Cmax is defined as the maximum observed plasma concentration measured at cycle 2 Day 1.|Cycle 2, Day 1|Data was not collected as no participants were enrolled in Part 2 of the study.||||||
2591899|NCT02265510|Secondary|Phase 1a, Part 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793|AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.|Cycle 1, Day 15|Data was not collected as no participants were enrolled in Part 2 of the study||||||
2591900|NCT02265510|Secondary|Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time|AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).|Cycle 1, Day 15|Data was not collected as no participants were enrolled in Part 2 of the study||||||
2591901|NCT02265510|Secondary|Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793|Tmax is the time to maximum (peak) observed plasma drug concentration.|Cycle 1, Day 15|Data was not collected as no participants were enrolled in Part 2 of the study||||||
2591902|NCT02265510|Secondary|Phase 1a, Part 2: Cmin: Minimum Observed Plasma Concentration Over the Dose Interval|Minimum observed plasma concentration measured at steady state (Day 15).|Cycle 1, Day 15|Data was not collected as no participants were enrolled in Part 2 of the study||||||
2591903|NCT02265510|Secondary|Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793|Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15).|Cycle 1, Day 15|Data was not collected as no participants were enrolled in Part 2 of the study||||||
2591904|NCT02265510|Secondary|Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time t|AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.|Cycle 1, Day 1|Data was not collected as no participants were enrolled in Part 2 of the study||||||
2591905|NCT02265510|Secondary|Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793|Tmax is the time to maximum (peak) observed plasma drug concentration.|Cycle 1, Day 1|Data was not collected as no participants were enrolled in Part 2 of the study||||||
2591907|NCT02265510|Secondary|Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for Itacitinib|AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).|Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2|The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis|||nM*hr||Standard Deviation|Mean
2591908|NCT02265510|Secondary|Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for Itacitinib|Tmax is the time to maximum (peak) observed plasma drug concentration.|Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2|The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis|||hr||Full Range|Median
2591909|NCT02265510|Secondary|Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration of Itacitinib|Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15).|Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2|The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis|||nM||Standard Deviation|Mean
2591910|NCT02265510|Secondary|Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793|AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.|Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2|The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis|||nM*hr||Standard Deviation|Mean
2591911|NCT02265510|Secondary|Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793|Tmax is the time to maximum (peak) observed plasma drug concentration. Summary of Steady-State, Day 15, was evaluated by dosing regimen. For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.|Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2|The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis|||hours (hr)||Full Range|Median
2591912|NCT02265510|Secondary|Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793|Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.|Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2|The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis|||nM||Standard Deviation|Mean
2591913|NCT02265510|Secondary|Phase 2: Number of Participants With at Least One TEAE and SAE|An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last dose of study drug.|From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 1.3 years)|Safety evaluable population included all participants exposed to ≥ 1 dose of study drug.|||Participants|||Count of Participants
2591914|NCT02265510|Secondary|Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment|Response rate is defined as the percentage of participants who achieved best overall response (BOR) as determined by IWG response criteria of investigator's assessment. A participant was considered an objective responder based on the following- Solid tumors: participant had a best overall response (BOR) of CR or PR, Lymphoma: participant had a BOR of complete radiologic response/complete metabolic response or partial remission/partial metabolic response, AML: participant had a BOR of CR, CRi, morphological leukemia-free state (MLFS), or PR, MDS: participant had a BOR of CR, PR, or marrow CR, MDS/myeloproliferative neoplasm (MPN): participant had a BOR of CR, PR, or marrow response, MM: participant had a BOR of stringent CR, CR, very good PR, PR, or MR. Subjects are combined by tumor type for this analysis.|Baseline through end of study (Up to approximately 4.5 years)|Efficacy evaluable population included all participants exposed to ≥ 1 dose of study drug.|||Participants|||Count of Participants
2591915|NCT02265510|Primary|Phase 2: Objective Response Rate (ORR) in Hematological Malignancies|ORR is defined as the proportion of participants who achieved complete response (CR), CR with incomplete hematologic recovery (CRi), partial response (PR), or hematologic improvement (HI), using the IWG response criteria.|Baseline through end of study (Up to approximately 4.5 years)|Efficacy evaluable population included all participants exposed to ≥ 1 dose of study drug.|||Participants|||Count of Participants
2591926|NCT02265237|Secondary|Percentage of Participants in Arms A, B and C With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA >= LLOQ with at least 6 weeks of treatment.|Up to Treatment Week 24 (end of treatment) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
2591987|NCT02263040|Primary|Number of Participants With Seroconversion to A/Texas/50/2012 (H3N2)|Four-fold or higher rise in titres to A/Texas/50/2012 (H3N2) as measured by hemagglutination inhibition assay|21 days post vaccination (18-28)||||Participants|||Count of Participants
2591916|NCT02265510|Primary|Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last dose of study drug.|From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 3.4 years)|Safety evaluable population included all participants exposed to ≥ 1 dose of study drug.|||Participants|||Count of Participants
2591917|NCT02265341|Other Pre-specified|Rate of FGFR Fusions|Will be described, and association with confirmed tumor response and/or clinical benefit will be investigated using a Fisher's exact test.|Up to a maximum follow-up of 3.3 years|||||||
2591918|NCT02265341|Other Pre-specified|Rate of Circulating-free Tumor Deoxyribonucleic Acid Mutations|Will be described, and association with confirmed tumor response and/or clinical benefit will be investigated using a Fisher's exact test.|Up to a maximum follow-up of 3.3 years||2020-06-30|06/2020||||
2591919|NCT02265341|Other Pre-specified|Changes in Patient-reported Outcomes (Quality of Life and Symptoms), Assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, EORTC QLQ-BIL21, Skindex-16, and Bowel Function Questionnaire|The Uniscale assessment of overall quality of life will be used. The Was It Worth It questionnaire will determine patient's satisfaction with the study. Scale score trajectories over time will be examined using stream plots and mean plots with standard deviation error bars overall. Changes from baseline at each cycle will be statistically tested using paired t-tests, and standardized response means will be interpreted using Cohen's (1988) cut-offs. Correlation between outcomes will employ Pearson and/or Spearman correlations at individual time points.|Up to a maximum follow-up of 3.3 years|||||||
2591920|NCT02265341|Secondary|Survival Time|Overall survival time is defined as the time from registration to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Time from registration to death due to any cause, assessed up to a maximum of 3.3 years||||months||95% Confidence Interval|Median
2591921|NCT02265341|Secondary|Progression-free Survival|Progression free survival (PFS) is defined as the time from the date of registration to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Time from registration to the earliest date of documentation of disease progression, assessed up to maximum 3.3 years from registration.||||months||95% Confidence Interval|Median
2591922|NCT02265341|Secondary|Overall Toxicity Rate, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)|"The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below."|Up to 10 months of treatment||||percentage of patients|||Number
2591923|NCT02265341|Secondary|CA 19-9 Response|This test measures the amount of a protein called CA 19-9 (cancer antigen 19-9) in the blood. CA 19-9 is a type of tumor marker. Tumor markers are substances made by cancer cells or by normal cells in response to cancer in the body.CA 19-9 was collected at baseline and on day one of each cycle. A CA 19-9 response is defined to be a >= 50% reduction from baseline. The CA 19-9 response rate (percentage) will be estimated by the number of CA 19-9 responses divided by the total number of evaluable patients.|Up to 10 months of treatment|Only patients who had baseline and subsequent CA 19-9 levels measured in the study are evaluable for this analysis.|||percentage of patients|||Number
2591924|NCT02265341|Primary|Clinical Benefit Rate (Percentage), Which Includes Confirmed Tumor Response (Complete Response [CR] or Partial Response [PR]) or Stable Disease (SD)|A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 8 weeks apart. The proportion of clinical benefit rate will be estimated by the number of patients with clinical benefit (confirmed CR, confirmed PR, or SD for 4 or more cycles) divided by the total number of evaluable patients. Complete Response (CR): All of the following must be true:a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to <1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the BSD (see Section 11.41). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the MSD. Please refer to RECIST v1.1 response criteria for more details.|Up to 10 months of treatment|Only patients who received treatment for at least 8 weeks are evaluable for this outcome (i.e. one patient refused further treatment and was therefore unevaluable for response at 8 weeks)|||percentage of patients||95% Confidence Interval|Number
2591925|NCT02265237|Secondary|Percentage of Participants in Arms A, B and C With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug (ITT population) with at least one post-treatment HCV RNA value, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
2591942|NCT02264353|Secondary|Respiratory Arousal Threshold|Arousal Threshold was measured as the average nadir epiglottic airway pressure immediately before electroencephalogram (EEG) arousal. It was measured with an epiglottic pressure catheter. The epiglottic catheter/balloon is linked in a pressure catheter inserted through the de-congested, anesthetized nostril and the tip of the catheter located at hypopharyngeal area.|14 days (during overnight sleep study after donepezil or placebo is given)||||cm H20||Full Range|Mean
2591927|NCT02265237|Secondary|Percentage of Participants With SVR12 in Participants Receiving 16 Weeks (Arm B) of Treatment Compared to Participants Receiving 24 Weeks of Treatment (Arm C)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants|||Number
2591928|NCT02265237|Secondary|Percentage of Participants With SVR12 in Participants Receiving 12 Weeks (Arm A) of Treatment Compared to Participants Receiving 16 Weeks of Treatment (Arm B)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants|||Number
2591929|NCT02265237|Primary|Percentage of Participants in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||97.5% Confidence Interval|Number
2591930|NCT02264977|Secondary|Number of Participants With 1 Month Device Related Endoleaks Assessed by an Independent Core Lab|Device-related endoleaks are defined as the presence of contrast within the aneurysm sac originating from the junction between any Branched TAG® Device component and the landing zone (endoleak type IA or IB) OR the junction between the Aortic Component and either the Side Branch Component or the Aortic Extender (type III endoleak).|1 month post procedure|Two participants not assessed for endoleaks at 1 month.|||Participants|||Count of Participants
2591931|NCT02264977|Secondary|Number of Participants With 1 Month Side Branch Primary Patency Assessed by an Independent Core Lab||1 month post procedure|One participant not assessed for patency at 1 month.|||Participants|||Count of Participants
2591932|NCT02264977|Primary|Number of Participants With Primary Procedural Side Branch Patency|The presence of forward flow through the implanted Side Branch Component into the target branch vessel.|At conclusion of the treatment procedure (day 0)||||Participants|||Count of Participants
2591933|NCT02264977|Primary|Number of Participants With Successful Study Device Deployment|Absence of deployment failure will be considered a successful deployment. Deployment failure will be considered the failure of any Branched TAG® Device component (Aortic Component, Aortic Extender, or SB Component) to be released from the delivery catheter resulting in a serious adverse event (SAE) due to mechanical failure or use error.|During treatment procedure (day 0)||||Participants|||Count of Participants
2591934|NCT02264977|Primary|Number of Participants With Successful Study Device Access|Access to the aneurysm and target landing zone location is obtained via conventional vascular access and endovascular techniques.|During treatment procedure (day 0)||||Participants|||Count of Participants
2591935|NCT02264821|Primary|Morphine Consumption|Morphine consumption with PCAIV|30 hours after spinal injection T0||||milligrammes||Inter-Quartile Range|Median
2591936|NCT02264821|Secondary|Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.|Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus?|30 hours after spinal injection|||||||
2591937|NCT02264821|Primary|Duration of Effective Analgesia|T0 until first request of morphine PCAIV|30 hours after spinal injection T0||||minutes||Inter-Quartile Range|Median
2591938|NCT02264574|Secondary|Rate of Sustained Hemoglobin Improvement|Percent of subjects with hemoglobin increase ≥ 2 g/dL over baseline continuously for ≥ 56 days without blood transfusions or growth factors.|Results at an overall median follow-up time of 31.3 months.|Intention to treat|||percentage of participants|||Number
2591939|NCT02264574|Secondary|PFS in High-risk Subpopulation|PFS by IRC as defined in primary endpoint was analyzed within a high-risk subpopulation which defined as randomization subjects with del17p/TP53 mutation or del 11q at baseline per central lab results.As the median PFS was not reached in the experimental (Ibr+Ob) arm at time of analysis, Kaplan Meier point estimates of the PFS rate at 30 months was presented.|Results at an overall median follow-up of 31.3 months|High-risk Subpopulation|||Percent||95% Confidence Interval|Number
2591940|NCT02264574|Primary|Progression Free Survival (PFS)|PFS is defined as time from the date randomization to the date of first IRC-confirmed disease progression (PD) or date of death due to any cause, whichever occurs first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death. Assessment of disease progression was conducted in accordance with the IWCLL 2008 criteria with the modification that treatment-related lymphocytosis in the absence of other signs or symptoms of disease progression will not be considered progressive disease. As the median PFS was not reached in the experimental (Ibr+Ob) arm at the time of the analysis, Kaplan Meier point estimates of the PFS rate at 30 months are presented.|The primary analysis was performed after observing 94 PFS events as pre-specified in the study protocol. The median follow-up time was 31.3 months at the time of the analysis.|Intention to Treat|||percent||95% Confidence Interval|Number
2591941|NCT02264353|Other Pre-specified|Loop Gain|The sensitivity of the ventilatory control system (loop gain) was quantified by fitting a simplified mathematical model to the spontaneous ventilatory pattern of obstructive sleep apnea (OSA). The sensitivity of the ventilatory control system (loop gain) was quantified by fitting a simplified mathematical model to the spontaneous ventilatory pattern of OSA 21. Loop gain is reflected in the size of the ventilatory overshoot following a ventilatory perturbation (hypopnea/apnea), where loop gain = response/disturbance. Ventilatory fluctuations are estimated using the square-root transformed nasal pressure waveform. Loop gain was reported as the ventilatory response to a 1 cycle/min disturbance (LG1); a value of LGn>1 yields periodic central apnea. Calculations were performed using MATLAB|14 days (during overnight sleep study after donepezil or placebo is given)||||Unitless||Standard Deviation|Mean
2591963|NCT02263326|Secondary|Change in LDL Cholesterol From Baseline to Week 48|Change in Low-density lipoprotein (LDL) cholesterol between arms will be presented in the attached statistical analysis table|Baseline and Week 48|Population with LDL cholesterol data available at baseline and week 48|||mg/dL||Inter-Quartile Range|Median
2591943|NCT02264353|Primary|Apnea Hypopnea Index (AHI)|The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation. A higher AHI value indicates more severe sleep apnea|14 days (during overnight sleep study after donepezil or placebo is given)||||events/hour||Standard Deviation|Mean
2591944|NCT02264249|Secondary|Procedure Complications (Decrease in Oxygen Saturation)|The patients will be evaluated for complications namely decrease in oxygen saturation during the procedure (Esophagogastroduodenoscopy and colonoscopy) in three groups.|1 day||||participants|||Number
2591945|NCT02264249|Secondary|pH of Gastric Fluid of Different Bowel Preparation Regimens|The pH of gastric fluid for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations.|1 day||||pH||Standard Deviation|Mean
2591946|NCT02264249|Primary|Residual Gastric Volumes of Different Bowel Preparation Regimens|The residual gastric volume for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations.|1 day||||mL||Standard Deviation|Mean
2591947|NCT02263911|Primary|PK: Maximum Concentration (Cmax) of Baricitinib||Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose|All randomized participants.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2591948|NCT02263911|Primary|PK: Area Under the Concentration Versus Time Curve From Zero to Last Measurable Concentration (AUC[0-tlast]) of Baricitinib||Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose|All randomized participants.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2591949|NCT02263911|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Baricitinib||Day 1: Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 Hours Post-dose|All randomized participants.|||nanogram*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2591950|NCT02263833|Other Pre-specified|Percentage of Participants on ESA Therapy Who Were Switched to Mircera Having a Hemoglobin Concentration in the Range of 10 to 12 g/dL||Up to 4 years|||||||
2591951|NCT02263833|Other Pre-specified|Percentage of ESA Naïve Participants Having an Increase in Hemoglobin (Hb) Level of at Least 1 g/dL From Baseline and Reaching the Hb Level Greater Than or Equal to (>/=) 11 g/dL Without Red Blood Cell Transfusion||Up to 4 years|||||||
2591952|NCT02263833|Primary|Percentage of Participants With an Adverse Drug Reaction (ADR)|"ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. It was defined as any AE categorized as definitely related,probably related, possibly related, and unknown by investigators. In case that an ADR was not written on local Korean Mircera label, it was classified as Unexpected. An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera."|At physician's discretion, up to 4 years|Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.|||percentage of participants|||Number
2591953|NCT02263833|Primary|Percentage of Participants With an Adverse Event (AE) and a Serious Adverse Event|An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. It is any AE that at any dose fulfills at least one of the following criteria: is fatal; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above.|At physician's discretion, up to 4 years|Safety population included all participants who received at least a dose of Mircera and had the safety assessment at least once.|||percentage of participants|||Number
2591954|NCT02263547|Secondary|Secondary Outcome Measure: Mean Percentage Change of Serum Teriflunomide Levels Percentage Change of Teriflunomide Concentrations at Day 8, Day 14, Day 26 ad Day 36 Following Administration of Colestipol Hydrochloride Tablets.|The last blood draw will be about 50 days from the start of the study|duration of study about 50 days||||percentage change in teriflunomide level||Standard Deviation|Mean
2591955|NCT02263547|Primary|Primary Outcome Measures: Teriflunomide Concentrations at Day 28|After receiving 14 days of teriflunomide, participants will take 11 days of colestipol to wash out the teriflunomide (measuring the levels of teriflunomide in the blood at each visit)|28 days after the start in the study||||teriflunomide level (mcg/ml)||Standard Deviation|Mean
2591956|NCT02263365|Other Pre-specified|Length of Index Admission||30 day|Data was not collected.||||||
2591957|NCT02263365|Secondary|Mild Dehydration - Subjective Report of Difficulty in Managing Fluid Balances and Stoma Care||30 days|Data was not collected.||||||
2591958|NCT02263365|Secondary|Moderate Dehydration Resulting in Outpatient Visits or ER Intervention That is =/<24hrs That Did Not Require Hospital Admission||30 day|Data was not collected.||||||
2591959|NCT02263365|Primary|Incidence of 30 Day Readmission (Severe Dehydration)||30 day|Data was not collected.||||||
2591960|NCT02263326|Other Pre-specified|Residual Viremia by HIV-1 Single-copy Assay|Difference in HIV-1 detection by the HIV-1 single copy assay between arms will be presented in statistical analysis|48 weeks|Participants with HIV-1 single copy assays performed at baseline and week 48 timepoints|||copies/mL||Standard Deviation|Mean
2591961|NCT02263326|Secondary|Drug Resistance Associated Mutations|Drug resistance mutations measured by HIV genotyping in patients with confirmed virologic failure|48 weeks||||Participants|||Count of Participants
2591962|NCT02263326|Secondary|Change in Creatinine Clearance From Baseline to Week 48|Change in Creatinine Clearance between arms will be presented in the attached statistical analysis table|Baseline and Week 48|Population with creatinine clearance data available at baseline and week 48|||ml/min||Inter-Quartile Range|Median
2594345|NCT02233738|Secondary|SF-12 Health Survey Mental Summary Score at Baseline|Mental summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health|30 days prior to Baseline||||score on a scale||Standard Deviation|Mean
2591968|NCT02263131|Secondary|Percentage of Subjects With a Pre-vaccination (Day 0) HI Antibody Titer < 1:40, Minimum Four-fold Rise in Post-vaccination (Day 28) HI Antibody Titer|Percentage of subjects with a pre-vaccination (Day 0) HI antibody titer < 1:40, and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer|Day28(+7)|||||||
2591969|NCT02263131|Secondary|GMR of HI Antibody Titer Before Vaccination and After Vaccination|Geometric Mean Ratio (GMR), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.|Day28(+7)|||||||
2591970|NCT02263131|Secondary|GMT of HI Antibody Titer Before Vaccination and After Vaccination|Geometric Mean Titer (GMT), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.|Day28(+7)|||||||
2591971|NCT02263131|Primary|Percentage of Subjects Achieving Seroconversion and Seroprotection for HI Antibody After Administration of the Study Vaccine|Seroconversion: a pre-vaccination (Day 0) hemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination (last vaccination + Day 28) HI antibody titer ≥ 1: 40 (Case 1), or a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (last vaccination + Day 28) HI antibody titer (Case 2), * Seroprotection: post-vaccination (Day 28) HI antibody titer ≥ 1:40|up to Day28(+7)||||percentage of participants||95% Confidence Interval|Number
2591972|NCT02263131|Primary|Solicited Local & General Adverse Event, Unsolicited Adverse Event|Solicited local reaction: pain, tenderness, redness, swelling Solicited general reactions: fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia|up to Day28(+7)||||percentage of paticipants||95% Confidence Interval|Number
2591973|NCT02263118|Secondary|Mean Change in Weight-for-Age Z-score|"We used the World Health Organization Anthro software (http://www.who.int/childgrowth/software/en/) to calculate z-scores for the weight-for-age anthropometric indicator of participants' infants at the beginning and at the end of the project. The software is based on the WHO Child Growth Standards and allowed to compare measurements of infants to the normal growth standards. The Z-score indicates the number of standard deviations away from the mean. The indicator is particularly useful to detect abnormal growth patterns in infants' development. For instance, an infant whose weight falls in the -2 z-score for the weight-for-age anthropometric indicator is underweight. Below -3, the child is severely underweight. Similarly, a child whose weight-for-age is above a +1 z-score may have a growth problem.~We report the mean change of the z-scores for the weight-for-age anthropomorphic indicator of participants' babies."|Baseline at December 2013 and 23 weeks later in May 2014||||z-score||95% Confidence Interval|Mean
2591974|NCT02263118|Secondary|Number of Text-messages Exchanged in Virtual Communities|We were interested in the activity of virtual communities in terms of sent text-messages.|December 2013 - May 2014, 23 weeks|"In virtual communities, participants were added to 1 of 3 peer-to-peer groups. They could communicate by sending SMSs to a short-code number. In the hybrid setup, participants were added to 1 of 3 peer-to-peer groups, but in addition received information regarding breastfeeding practices and could communicate with a health professional."|||Number of text messages|||Number
2591975|NCT02263118|Secondary|Qualitative Nature of Health-related Text-messages|Specifically, we were interested in classifying individual text-messages as social support or health related.|December 2013 - May 2014, 23 weeks||||Number of text messages|Participants||Number
2591976|NCT02263118|Primary|Number of Participants With Changes in Knowledge|Specifically, we were interested in: the number of participants who switched from an incorrect to a correct knowledge regarding exclusive breastfeeding during the experiment (learned the message); the number of participants who had a correct knowledge but switched to an incorrect one during the experiment (forgot the message); the number of participants who had an incorrect knowledge and kept it until the end of the experiment (continued to be unaware); the number of participants who had a correct knowledge and kept it until the end of the experiment (remembered the message).|December 2013 - May 2014, 23 weeks||||participants|||Number
2591977|NCT02263040|Secondary|Number of Participants Reporting Adverse Event: Systemic|"Any systemic adverse event following immunization,self reported in daily diary Includes the maximum value reported for any one of: myalgia, arthralgia, headache, malaise, fatigue, weakness, sweating, shivering, or feverishness~Defined as:~None: Not at all Mild: Present, but did not interfere with activities Moderate: Interfered with activities, but didn't prevent them Extreme: Prevented activities"|7 days||||Participants|||Count of Participants
2591978|NCT02263040|Secondary|Number of Participants Reporting Adverse Event: Injection Site|Any local adverse event following immunization,self reported in daily diary Includes the maximum values for any one of: redness, warmth, swelling, or bruising|7 days|All participants were able to provide data|||Participants|||Count of Participants
2591979|NCT02263040|Secondary|Geometric Mean Fold Ratio (GMFR): B/Massachusetts/02/2012 Ether-treated|GMFR (mean fold increase) time2/time1, as measured by HAI titres|21 days (18-28)||||fold ratio||95% Confidence Interval|Geometric Mean
2591980|NCT02263040|Secondary|Geometric Mean Fold Ratio (GMFR): B/Phuket/3073/2013 Ether-treated|GMFR (mean fold increase) time2/time1, as measured by HAI titres|21 days (18-28)||||fold ratio||95% Confidence Interval|Geometric Mean
2591981|NCT02263040|Secondary|Geometric Mean Fold Ratio (GMFR): A/Texas/50/2012|GMFR (mean fold increase) time2/time1, as measured by HAI titres|21 days (18-28)||||fold ratio||95% Confidence Interval|Geometric Mean
2591982|NCT02263040|Secondary|Geometric Mean Fold Ratio (GMFR): A/Switzerland/9715293/2013|GMFR (mean fold increase) time2/time1, as measured by HAI titres|21 days (18-28)||||fold ratio||95% Confidence Interval|Geometric Mean
2591983|NCT02263040|Secondary|Geometric Mean Fold Ratio (GMFR) Against A/California/07/2009 (H1N1)|GMFR (mean fold increase) time2/time1, as measured by hemagglutination inhibition assay|21 days (18-28)||||fold ratio||95% Confidence Interval|Geometric Mean
2591984|NCT02263040|Primary|Number of Participants With Seroconversion to B/Massachusetts/02/2012|Four fold or higher increase in titres to B/Massachusetts/02/2012 as measured by hemagglutination inhibition assay|21 days post-vaccination (18-28)||||Participants|||Count of Participants
2591985|NCT02263040|Primary|Number of Participants With Seroconversion to A/Switzerland/9715293/2013 (H3N2)|Four-fold or higher rise in titres against A/Switzerland/9715293/2013 (H3N2) as measured by hemagglutination inhibition assay|21 days post vaccination (18-28)||||Participants|||Count of Participants
2591986|NCT02263040|Primary|Number of Participants With Seroconversion to Influenza B/Phuket/3073/2013|Four fold or higher increase in titres to B/Phuket/3073/2013 as measured by hemagglutination inhibition assay|21 days post-vaccination (18-28)||||Participants|||Count of Participants
2591988|NCT02263040|Primary|Number of Participants With Seroconversion to A/California/07/2009 (H1N1)|Seroconversion to influenza strains contained in the vaccine, as measured by hemagglutination inhibition (HAI) assay. 4-fold or greater increase.|21 days (18-28)|A blood sample from one participant was hemolysed and not available for analysis|||Participants|||Count of Participants
2591989|NCT02262754|Secondary|Plasma Concentration of Naproxen|Data was calculated by setting concentration values below the LLOQ to zero. The LLOQ was <1000 ng/mL.|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||ng/mL||Standard Deviation|Mean
2591990|NCT02262754|Secondary|Plasma Concentration of PF-06372865|Data was calculated by setting concentration values below the lower limit of quantification (LLOQ) to zero. The LLOQ was <0.0100 nanogram per milliliter (ng/mL).|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||ng/mL||Standard Deviation|Mean
2591991|NCT02262754|Secondary|Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4|Participants rated their study treatment by GESM questionnaire. It was a qualitative measure of efficacy utilizing a 4-point Likert scale ranging from 1 (poor) to 4 (excellent), where higher score indicated a better overall response to the treatment. Number of participants who reported a particular score had been reported.|Week 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||participants|||Number
2591992|NCT02262754|Secondary|Patient Global Impression of Change (PGI-C) Score|PGI-C was a participant rated instrument to measure participant's assessment of change in his or her overall status since the previous visit on a 7-point scale; ranging from 1 (very much improved) to 7 (very much worse), where higher scores indicated more worsening.|Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||units on a scale||90% Confidence Interval|Least Squares Mean
2591993|NCT02262754|Secondary|Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4|Participant rated 5-point Likert scale ranging from 0 (no pain) to 4 (worst possible pain) with a higher score indicating greater level of pain.|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||units on a scale||90% Confidence Interval|Least Squares Mean
2591994|NCT02262754|Secondary|Chronic Low Back Pain (CLBP) Responder Index Analysis|Participants were successful responders if they had any of the following: >=30 percent reduction in mean daily average LBPI from baseline to particular week; decrease of >=30 percent in participant's global assessment of low back pain (disease activity) from baseline to particular week or no worsening (increase) in RMDQ total score from baseline to particular week.|Week 1, 2, 3, 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.|||participants|||Number
2591995|NCT02262754|Secondary|Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4|This test assesses verbal learning and memory. Participants are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate learning trials. The total recall score ranges from 0 (no memory) to 36 (best memory) while the delayed recall trial score ranges from 0 (no memory) to 12 (best memory); higher scores indicated greater verbal learning and recall.|Baseline, Week 2, Week 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||units on a scale||Standard Deviation|Mean
2591996|NCT02262754|Secondary|Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4|Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.|Baseline, Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.|||units on a scale||90% Confidence Interval|Mean
2591997|NCT02262754|Secondary|Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3|Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.|Baseline, Week 1, 2, 3|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||units on a scale||Standard Deviation|Mean
2591998|NCT02262754|Secondary|Amount of Rescue Medication Used by the Participants|The amount of rescue medication (Acetaminophen [paracetamol]) used was reported. Participants were permitted to use any commercial product of acetaminophen tablet/caplet/capsule.|Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||mg||Standard Deviation|Mean
2591999|NCT02262754|Secondary|Number of Days Participants Used the Rescue Medication|The number of days for which the participants used the rescue medication were reported. Participants recorded the usage of acetaminophen rescue medication in the daily diary.|Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||days||Standard Deviation|Mean
2592000|NCT02262754|Secondary|Number of Participants Using Rescue Medication|Participants were permitted to use any commercial product (tablet/caplet/capsule) of acetaminophen (paracetamol) 500 mg as a rescue medication. Number of participants who used rescue medication were reported.|Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||participants|||Number
2594346|NCT02233738|Secondary|SF-12 Health Survey Physical Summary Score at 6 Months|Physical summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health|6 months||||score on a scale||Standard Deviation|Mean
2592001|NCT02262754|Secondary|Time to Withdrawal Due to Lack of Efficacy|"Kaplan Meier and Cox Proportional Hazards analyses were to be used to compute the time to withdrawal due to lack of efficacy. Withdrawal due to lack of efficacy was identified from the participant summary case report form (CRF) page and where reason was identified as Insufficient Clinical Response. Time to withdrawal was calculated as Date of withdrawal - Date of Randomization."|Baseline up to Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.|||days||90% Confidence Interval|Median
2592002|NCT02262754|Secondary|Number of Participants Withdrawn Due to Lack of Efficacy|Participants withdrew from the study due to lack of efficacy (insufficient clinical response) were reported.|Baseline up to Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.|||participants|||Number
2592003|NCT02262754|Secondary|Number of Participants With Sustained Response Rates in Daily Average LBPI NRS Scores at Greater Than or Equal to (>=) 30 Percent and >=50 Percent Reduction From Baseline|Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10. Percentage of reduction from baseline in the daily average LBPI NRS score was calculated as: ([daily value - baseline value] divided by baseline value) multiplied by 100. Number of participants with sustained response rates (for a minimum of 4 consecutive days) in the daily average LBPI NRS scores that were at >=30 percent and >=50 percent reduced from baseline were reported.|Baseline up to Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.|||participants|||Number
2592004|NCT02262754|Secondary|Percent Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2, 3 and 4|Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||percent change||Standard Deviation|Mean
2592005|NCT02262754|Secondary|Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2 3 and 4|Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.|Baseline, Week 1, 2, 3, 4|"FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, n signifies participants who were evaluable at the specified time point for each arm."|||units on a scale||90% Confidence Interval|Least Squares Mean
2592006|NCT02262754|Primary|Change From End of Treatment Visit in Physician's Withdrawal Checklist (PWC) Score at Follow-up Visit|PWC is a 20 item physician rated interview to measure anxiolytic drug withdrawal-related signs and symptoms. Each individual item score ranges from 0 (not present) to 3 (severe), where higher scores = more affected condition. PWC total score range from 0 (not present) to 60 (severe), where higher score = more affected condition. Change: score at follow-up visit minus score at the end of treatment visit.|End of treatment (Day 30), follow-up (Day 44)|Safety analysis set included all participants who received at least 1 dose of study treatment.|||units on a scale||90% Confidence Interval|Least Squares Mean
2592007|NCT02262754|Primary|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide =1, suicide attempt =2 (response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior =3 (Yes on preparatory acts or behavior), suicidal ideation =4 (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior =7 (Yes on Has participant engaged in non-suicidal self-injurious behavior)."|Screening, Baseline, Week 1, 2, 3, 4|Data was not collected for this outcome measure as per study team’s decision, since it was a semi-structured interview and was difficult to pull accurate scores from it.||||||
2592008|NCT02262754|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Participants with abnormal ECG findings were reported. Criteria for potential clinical concern in ECG parameters: maximum (max.) PR interval of >=300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia's Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum of >=25 percent (%) increase from baseline (IFB) value of >200 msec and >=50% for baseline value of less than or equal to (<=) 200 msec for PR interval, maximum increase from baseline of >=50% for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia's Correction).|Baseline up to Follow-up (44 days)|"Safety analysis set included all participants who received at least 1 dose of study treatment. Here, n signifies the number of participants evaluable for the specific category."|||participants|||Number
2592009|NCT02262754|Primary|Number of Participants With Vital Sign Abnormalities|Participants who met the criteria for abnormal findings in vital signs data were reported. Criteria for abnormalities in vital signs: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm) or >120 bpm. Maximum increase or decrease from baseline in supine SBP >=30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg.|Baseline up to Follow-up (44 days)|Safety analysis set included all participants who received at least 1 dose of study treatment.|||participants|||Number
2592021|NCT02262728|Secondary|Absolute Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels at Follow-up Week 24 (Week 36)||Follow-up Week 24 (Week 36)|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.|||Units per Liter (U/L)||Standard Deviation|Mean
2594347|NCT02233738|Secondary|SF-12 Health Survey Physical Summary Score at 3 Months|Physical summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health|3 months||||score on a scale||Standard Deviation|Mean
2592010|NCT02262754|Primary|Number of Participants With Laboratory Abnormalities|Abnormality criteria included: hemoglobin, hematocrit and red blood cells (RBCs) (less than [<] 0.8*lower limit of normal [LLN]); white blood cells (WBC) (<0.6*LLN, greater than [>] 1.5*upper limit of normal [ULN]); MCV, MCH, MCHC (<0.9*LLN, >1.1*ULN); platelets (<0.5*LLN>, >1.75*ULN); neutrophils, lymphocytes(<0.8*LLN, >1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin (>1.5*ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (>3*ULN); total protein, albumin (<0.8*LLN, >1.2*ULN); creatinine, blood urea nitrogen (>1.3*ULN); glucose (<0.6*LLN, >1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN, >1.1*ULN); urine pH (<4.5, >8); qualitative urine glucose, ketones, protein, blood values (greater than or equal to [>=] 1) in urine dipstick test; urine RBC, WBC (>=20); hyaline casts (>1), bacteria (>20).|Baseline up to 28 days after the last dose of study treatment (Day 56)|"Safety analysis set included all participants who received at least 1 dose of study treatment. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||participants|||Number
2592011|NCT02262754|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. The SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline up to 28 days after the last dose of study treatment (Day 56)|Safety analysis set included all participants who received at least 1 dose of study treatment.|||participants|||Number
2592012|NCT02262754|Primary|Change From Baseline in Daily Low Back Pain Intensity (LBPI) Score as Measured by an 11-point Numeric Rating Scale (NRS) at Week 4|Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. Baseline value was calculated as the mean of the scores over the last 7 days in the placebo run-in period, prior to randomization. Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.|Baseline, Week 4|FAS included all participants randomized and who had received at least 1 dose of randomized treatment.|||units on a scale||90% Confidence Interval|Mean
2592013|NCT02262728|Secondary|Percentage of Participants With SVR12 Who Maintained to Have HCV RNA <LLOQ Until the End of 3 Years Follow up|Percentage of participants with SVR12 who maintained to have HCV RNA <LLOQ (15 IU/mL) until the end of 3 years follow up were reported.|Week 24 post treatment until the end of 3-year follow-up|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug.|||Percentage of participants|||Number
2592014|NCT02262728|Secondary|Percentage of Participants With Viral Relapse|Viral relapse is defined as participants who do not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ (15 IU/mL) at Week 16, 24 or 36.|Week 16, 24 and 36|The ITT analysis set who failed achieving SVR. Since all participants achieved SVR, the number of participants for this endpoint (viral relapse) analysis was zero.||||||
2592015|NCT02262728|Secondary|Percentage of Participants With On-treatment Failure|On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment.|Week 12|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2592016|NCT02262728|Secondary|Pre-dose (Trough) Concentration (C0h) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|The C0h is the pre-dose plasma concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|PK analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analyzed for this outcome measure at specific time point.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2592017|NCT02262728|Secondary|Minimum Plasma Concentration (Cmin) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|The Cmin is the minimum observed plasma concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|PK analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analyzed for this outcome measure at specific time point.|||ng/mL||Standard Deviation|Mean
2592018|NCT02262728|Secondary|Maximum Plasma Concentration (Cmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|The Cmax is the maximum observed plasma concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|Pharmacokinetic (PK) analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analyzed for this outcome measure at specific time point.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2592019|NCT02262728|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|The AUC(0-24) is area under the plasma concentration-time curve from time 0 to 24 hours after dosing.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|Pharmacokinetic (PK) analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analyzed for this outcome measure at specific time point.|||ng.h/mL||Standard Deviation|Mean
2592020|NCT02262728|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite)|Tmax is the time to reach maximum observed plasma concentration.|0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8|Pharmacokinetic (PK) analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analyzed for this outcome measure at specific time point.|||Hours||Full Range|Median
2592022|NCT02262728|Secondary|Percentage of Participants With HCV NS3/4A Sequence, NS5A and NS5B After End of Treatment in Participants Not Achieving SVR|Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. All participants in this study achieved SVR12. Therefore, reasons for not achieving SVR12 are not applicable.|Baseline, Day 3, Week 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and Year 1, 1.5, 2, 2.5, 3 after end of treatment|The ITT analysis set who failed achieving SVR. Since all participants achieved SVR, the number of participants for this endpoint analysis was zero.||||||
2592023|NCT02262728|Secondary|Percentage of Participants With SVR 4 Weeks After End of Study Drug Treatment (SVR4) and SVR 24 Weeks After End of Study Drug Treatment (SVR24)|Participants were considered to have achieved SVR4 and SVR24 if the HCV RNA was <LLOQ detectable or undetectable at 4 weeks and 24 weeks respectively after the end of study drug treatment. The LLOQ value was 15 IU/mL.|Week 16 and Week 36|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here , 'n' signifies number of participants evaluable for this outcome measure at specific time point.|||Percentage of Participants||95% Confidence Interval|Number
2592024|NCT02262728|Secondary|Percentage of Participants With On-Treatment Virologic Response|On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. The following thresholds were considered at any time point: <LLOQ undetectable, <LLOQ detectable, and <LLOQ undetectable or detectable. The LLOQ value was 15 IU/mL. Very rapid virologic response (vRVR) is undetectable HCV RNA at Week 2 while on treatment and Rapid virologic response (RVR) is undetectable HCV RNA at Week 4 while on treatment.|Week 1, 2, 4, 6, 8, 10, 12|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.|||Percentage of Participants|||Number
2592025|NCT02262728|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)|Participants were considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) was less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the end of study drug treatment.|Week 24|The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
2592026|NCT02262377|Secondary|Emergency Department Use|Number of emergency room visits based on chart review data collection.|This was collected at 21 weeks.||||participants|||Number
2592027|NCT02262377|Primary|Pain Medication Use|Number of participants reported pain medication in the past seven day. This was obtained at 21 weeks.|This was conducted at 21 weeks.||||Participants|||Count of Participants
2592028|NCT02262377|Primary|Pain Self Efficacy Scale|Pain Self Efficacy Questionnaire (PSEQ) - used to assess the confidence in performing activities while in pain. It is the sum of 10 items each with a 0-6 scale. Scores range from 0-60 and is done by simple addition. Higher scores indicate higher levels of confidence. (Nicholas 2007) This was conducted at 21 weeks.|This was conducted at 21 weeks.||||units on a scale||Standard Deviation|Mean
2592029|NCT02262377|Primary|Depression|Patient Health Questionnaire (PHQ-9) measures severity of depressive symptoms. It is a sum of 9 items each with a 0-3 units on a scale. Higher scores indicate higher levels of depression. A score of 0-4 is considered minimal or none in depression severity. A score of 5-9 is considered mild in depression severity. A score of 10-14 is considered moderate in depression severity. A score of 15-19 is considered moderately severe in depression severity. A score of 20-27 is considered severe in depression severity. (Kroenke 2009) This was conducted at 21 weeks.|This was conducted at 21 weeks.||||units on a scale||Standard Deviation|Mean
2592030|NCT02262377|Primary|Chronic Pain|Chronic pain reflects the average scores for the severity, interference and average pain subscales from the Brief Pain Inventory (BPI) Short Form (BPI-sf). BPI-sf is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on their daily functioning on a 10 point scale from 0 to 10 where higher scores indicate higher levels of pain. Average pain was obtained by asking the participant's what their average pain was in the past 7 days. Pain interference was calculated by adding the scores for questions 8a, b, c, d, e, f, and g and then dividing by seven. Pain severity was calculated by adding the scores for questions 2, 3, 4, and 5 and then by dividing by four. The average score for each subscale was obtained by adding all respective scores and then dividing each subscale total by the total number of participants.|This was conducted at 21 weeks.|Intention to Treat Analysis Results|||units on a scale||Standard Deviation|Mean
2592031|NCT02262364|Secondary|Change From Baseline to 12 Months in Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS)|"The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions.~A higher score on the KOOS questionnaire indicates fewer problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard."|12 months||||units on a scale||Standard Deviation|Mean
2592032|NCT02262364|Secondary|Change From Baseline to 12 Months in Pain as Measured by the Numeric Rating Scale (NRS)|"The Numeric Rating Scale (NRS) is a validated measure of knee pain. The NRS is an 11 point Likert type scale anchored by 0 no pain and 10 worst possible pain. Subjects rate their average pain over the last 24 hours."|12 months||||units on a scale||Standard Deviation|Mean
2592048|NCT02262039|Secondary|Mean ETCO2|mean End-tidal carbon dioxide concentration in the expired air|intraoperative||||mmHg||Standard Deviation|Mean
2592049|NCT02262039|Secondary|Subjective Pain Score|Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.|12 hours post-op||||units on a scale||Standard Deviation|Mean
2605752|NCT02107014|Primary|Change in IL-12p70 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2592033|NCT02262364|Secondary|Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire|"The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation.~The WOMAC pain subscale consists of five questions scored from 0 to 4. The pain score has a range of 0 (no pain) to 20 (maximal pain).~The WOMAC stiffness subscale consists of two questions scored from 0 to 4. The stiffness score has a range of 0 (no stiffness) to 8 (maximal stiffness).~The WOMAC physical function subscale consists of seventeen questions scored from 0 to 4. The physical function score has a range of 0 (no functional limitation) to 68 (maximal functional limitation)."|12 months||||units on a scale||Standard Deviation|Mean
2592034|NCT02262364|Primary|Adverse Events|Adverse Events and Serious Adverse Events|1 Year||||events|||Number
2592035|NCT02262260|Secondary|Proportion of Patients Who Gained ≥15 Letters|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥15 letters of visual acuity at month 12 as compared with baseline|12 months|Study completers- The patients who have completed 12 months of treatment and follow-up are defined as Study Completers|||Participants|||Number
2592036|NCT02262260|Secondary|Proportion of Patients Who Gained ≥10 Letters|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥10 letters of visual acuity at month 12 as compared with baseline|12 months|Study completers- The patients who have completed 12 months of treatment and follow-up are defined as Study Completers|||Participants|||Number
2592037|NCT02262260|Secondary|Proportion of Patients Who Gained ≥5 Letters|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥5 letters of visual acuity at month 12 as compared with baseline|12 months|Study completers- The patients who have completed 12 months of treatment and follow-up are defined as Study Completers|||Participants|||Number
2592038|NCT02262260|Secondary|Mean Number of Visits|Mean number of visits over a 12-month treatment period|12 months|Study completers- The patients who have completed 12 months of treatment and follow-up are defined as Study Completers. Statistical analysis not performed to compare visits|||Number of visits||Standard Error|Mean
2592039|NCT02262260|Secondary|Mean Number of Injections|Mean number of injections over a 12-month treatment period|12 months|Study completers- The patients who have completed 12 months of treatment and follow-up are defined as Study Completers. Statistical analysis not performed for the injection numbers|||Injections||Standard Error|Mean
2592040|NCT02262260|Secondary|Mean Change in Central Retinal Thickness (CRT)|CRT was assessed by Optical Coherence Tomography (OCT).|12 months|Study completers- The patients who have completed 12 months of treatment and follow-up are defined as Study Completers.|||Micrometers||Standard Error|Mean
2592041|NCT02262260|Primary|"Mean Change in Best-corrected Visual Acuity at Month 12"|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement|12 months|Study completers- The patients who have completed 12 months of treatment and follow-up are defined as Study Completers.|||Letters||Standard Error|Mean
2592042|NCT02262130|Secondary|Proportion of Patients Achieving Clinical Remission of Solar Urticaria|Proportion of patients showing no or less clinical signs or solar urticaria compared to baseline, under experimental conditions|4 and 12 weeks after the end of treatment|1 patient withdrawn between week 12 and week 20 (discontinuation)|||Participants|||Count of Participants
2592043|NCT02262130|Secondary|Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity|Proportion of patients achieving 50% improvement in solar urticaria intensity, compared to baseline, assessed by Visual Analogic Scale (scale extending from 0 to 10)|4 and 12 weeks after the end of treatment|1 patient withdrawn between week 12 and week 20 (discontinuation)|||Participants|||Count of Participants
2592044|NCT02262130|Secondary|Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting)|"Proportion of patients with minimal urticarial dose (MUD) increased compared to baseline, under experimental conditions (assessed by phototesting).~A small area of skin is exposed to increasing UVA doses with a solar simulator until an allergic reaction appears. The lower UVA dose triggering the urticaria is the MUD."|12 weeks after the end of treatment||||Participants|||Count of Participants
2592045|NCT02262130|Secondary|Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index< 6|"Proportion of patients for whom the treatment with omalizumab allowed achieving DLQI < 6.~The index extends from 0 to 30: 0 - 1 = no effect at all on patient's life / 2 - 5 = small effect on patient's life / 6 - 10 = moderate effect on patient's life / 11 - 20 = very large effect on patient's life / 21 - 30 = extremely large effect on patient's life"|4 and 12 weeks after the end of treatment|1 patient withdrawn between week 12 and week 20 (discontinuation)|||Participants|||Count of Participants
2592046|NCT02262130|Primary|Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting)|"Proportion of patients with minimal urticarial dose (MUD) increased compared to baseline, under experimental conditions (assessed by phototesting).~A small area of skin is exposed to increasing UVA doses with a solar simulator until an allergic reaction appears. The lower UVA dose triggering the urticaria is the MUD."|4 weeks after the end of treatment||||Participants|||Count of Participants
2592047|NCT02262078|Primary|Change in Pulmonary Capillary Wedge Pressure During Exercise|Pulmonary capillary wedge pressure is a measure of cardiac filling pressure, measured in millimeters of mercury (mmHg)|Baseline, after study drug dosing, approximately 4 minutes after starting exercise||||millimeters of mercury||Standard Deviation|Mean
2592051|NCT02262039|Secondary|Subjective Pain Score|Pain assessment via Visual Analogue Scale (VAS). Patients indicate pain on a continuous line which converts to a measured value in centimeters (cm). (Range: 0.0 and 10.0) - A score of 0 indicates no pain.|1 hour post-op||||units on a scale||Standard Deviation|Mean
2592052|NCT02262039|Primary|Narcotic Use (mg)|Total Morphine Equivalent - mean in mg|Operative and Post-operative (until time of discharge, typically 2-4 days)||||mg||Standard Deviation|Mean
2592053|NCT02262039|Primary|Narcotic Use (mg)|Total Morphine Equivalents - mean in mg|Post-operative (until time of discharge, typically 2-4 days)||||mg||Standard Deviation|Mean
2592054|NCT02262039|Primary|Narcotic Use (mg)|Total Morphine Equivalents - mean in mg|Intra-Operative on day of surgery||||mg||Standard Deviation|Mean
2592055|NCT02261974|Secondary|Mean Change From Baseline in Female Sexual Distress Scale - Revised (FSDS-R)|"The mean change in total FSDS-R score from baseline to six months post-intervention in the active arm compared to the sham arm. The FSDS-R is a 12-item patient-reported questionnaire and a validated scale used to measure sexually-related personal distress in women. Women rate 13 questions as Never (0), Rarely (1), Occasionally (2), Frequently (3), and Always (4), for a total score range of 0-52 (the individual question scores are summed to give the total score). A higher frequency of occurrences (which correlates to a total higher score) indicates a greater distress or a worse outcome. The numbers below represent the changes from baseline in mean FSDS-R total score. The baseline value is the FSDS-R total score at screening."|6 months|This population consists of all randomized subjects who completed a 6 month assessment.|||Units on a Scale||Standard Error|Mean
2592056|NCT02261974|Secondary|Mean Change From Baseline in the VSQ Vaginal Laxity Question (VLQ)|"Mean change in VSQ Vaginal Laxity Question (VLQ) score from baseline to 6 months post-intervention. The VLQ is one question. The global assessment of vaginal laxity is scored on a seven-point Likert type scale where the response to the question ranges from 1-7 where 1 = Very Loose and 7 = Very Tight. The Likert-scale is one of the most widely used bipolar scaling method instruments in survey research. The VSQ VLQs levels of vaginal laxity uses a balanced keying (an equal number of positive and negative statements) to obviate the problem of acquisition bias. Baseline VLQ is the score indicated that the screening visit."|6 months|This population consists of all randomized subjects who completed a 6 month assessment.|||Units on a Scale||Standard Error|Mean
2592057|NCT02261974|Secondary|Mean Change From Baseline in Vaginal Introitus Laxity Inventory (VALI) Total Score|"Vaginal Introitus Laxity Inventory (VALI) is a 12-item patient reported outcome measure designed to describe and quantify the nature of a female respondent's concern with the perception of laxity (looseness) and its impact on the qualities of satisfaction and enjoyment of her sexual functioning. Items of the VALI address the impact of laxity on the major aspects of the female sexual response cycle (i.e., sexual desire, arousal and orgasm), and quantify the patient's experience of sexual pleasure, sensitivity and satisfaction. The VALI items also address the potential impact of vaginal introitus laxity on sexual confidence and the patient's partner. All 12 items are measured on 5-point Likert scales (0= Very Poor, 1=Poor, 2=Moderate, 3=Good, 4=Very Good) and scores are summed to achieve a VALI Total score, range 0-48. A higher score corresponds to positive sexual satisfactions and functioning."|6 months|This population consists of all randomized subjects with a 6 month assessment.|||Units on a Scale||Standard Error|Mean
2592058|NCT02261974|Primary|Reporting Adverse Events (AEs)|Proportion of subjects in the active arm relative to those in the sham arm experiencing a treatment-related AE by six months post-intervention.|6 months|"Table includes treatment-emergent adverse events (AEs), defined as AEs that began or worsened in severity after treatment.~This population consists of all subjects who were randomized and who received a complete or partial treatment."|||Participants|||Count of Participants
2592059|NCT02261974|Primary|Mean Change From Baseline in Female Sexual Function Index (FSFI) Total Score|The mean change from baseline in FSFI total score in the active arm compared to the sham arm. The FSFI is a 19-item validated measure of female sexual function. It consists of 6 domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. Each item's score can range from 0-5 (or 1-5 in several instances). For individual domain scores, the scores of the individual items that comprise the domain are summed, and the sum is multiplied by the domain factor (factors are permanent and do not change). The 6 domain scores are then summed to obtain the FSFI total score. The total score ranges from 2-36. A higher score indicates a greater level of sexual function, while a lower score correlates to a greater level of sexual dysfunction. Within individual domains, a domain score of 0 indicates that the subject reported having no sexual activity during the past month. The baseline score is the FSFI total score from the screening visit.|6 months|This population consists of all randomized subjects who completed the six month assessment.|||Units on a Scale||Standard Error|Mean
2592060|NCT02261948|Secondary|Change in DLCO (Diffusion Lung CO)|Levosimendan induced changes on DLCO ( Diffusion Lung CO). DLCO is measured by the single breath-constant expiratory flow technique (Sensor Medics 2200, Yorba Linda, CA) and we calculate also the DLCO adjusted for hemoglobin. Dilution of CH4 is used to measure alveolar volume.|48 hours||||ml/mmHg/min||Standard Deviation|Mean
2592061|NCT02261948|Secondary|Changes in VE/VCO2|Levosimendan induced changes on VE/VCO2 (VE: Expired Volume - VCO2: carbon dioxide production) relationship|48 hours||||VE/VCO2 Slope||Standard Deviation|Mean
2592062|NCT02261948|Primary|Change in Peak VO2 (Oxygen Consumption )|Primary endpoints: Levosimendan induced changes in peak VO2 (Oxygen consumption )|48 hours||||ml/kg/min||Standard Deviation|Mean
2592063|NCT02261818|Primary|Depression With PHQ-9|PHQ-9 will be used to assess depression. The maximum score is 27. The scale is interpreted as follows: 0-4 no depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.|at 8 weeks|Patient participants|||units on a scale||Standard Deviation|Mean
2592064|NCT02261805|Secondary|Objective Response Rate|Objective response rate included the count of confirmed complete responses (CR) and partial responses (PR) and was based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.|2 years||||Participants|||Count of Participants
2592065|NCT02261805|Primary|Maximum Tolerated Dose|The dose of ganetespib at which 1 or more out of 3-6 patients experiences a dose-limiting toxicity|1 year||||mg/m^2|||Number
2592216|NCT02260492|Primary|Area Under the Serial FEV1-time Curve (AUC 0-12h)|Bioequivalence comparison of lung function (FEV1) for 12 hours after the first dose on Day 1 following OT329 Solis and Advair Diskus treatment. Serial lung function measurements were made pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose.|0-12 hours after dosing on Day 1|Intent-to-treat (ITT)|||Liters||Standard Deviation|Mean
2592066|NCT02261597|Secondary|Glucocorticoid Sensitivity- Percentage of IL-6 Positive Monocytes|Percentage of IL-6 positive monocytes following stimulation with LPS (100pg/mL) and varying concentrations of Dexamethasone|Monocytes are only obtained from the baseline blood draw, which occurs at 11am.|Data of 2 participants were excluded from analysis due to development of headache or Iv problems in the course of the experimental study day.|||Percentage of IL-6 positive monocytes||Standard Error|Mean
2592067|NCT02261597|Primary|Stress Reactivity to Physiological Challenge- Change in Serum Levels of Cortisol|HPA marker: Change in serum cortisol levels (ug/dL)|Baseline blood was obtained between 11am-12pm and prior to any Cold Pressor Tests (CPTs). Three CPTs were performed, with 1.5 hours between each one. The first CPT was done at 1pm. Blood draws were obtained 20min and 50 min after each CPT.|Data of 3 participants were excluded from analysis due to development of headache or Iv problems in the course of the experimental study day.|||ug/dL||Standard Error|Mean
2592068|NCT02261597|Primary|Inflammatory Response to Physiological Challenge- Change in Plasma Levels of IL-6|Inflammatory marker: Change in plasma levels of IL-6 (pg/mL).|Baseline blood was obtained between 11am-12pm and prior to any Cold Pressor Tests (CPTs). Three CPTs were performed, with 1.5 hours between each one. The first CPT was done at 1pm. Blood draws were obtained 20min and 50 min after each CPT.|Data of 3 participants were excluded from analysis due to development of headache or Iv problems in the course of the experimental study day.|||pg/mL||Standard Error|Mean
2592069|NCT02261493|Secondary|Time to Retreatment Eligibility|Time to retreatment eligibility is defined as the number of days from treatment cycle 1 injection to the return to an Investigator FWS rating of moderate or severe at maximum eyebrow elevation. The FWS is a 4-grade scale, where 0=none, 1=mild, 2=moderate, and 3=severe. Only subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation on Day 30 are included in the analysis.|12 Months|Intent-to-Treat: all randomized subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation|||Days||Standard Deviation|Median
2592070|NCT02261493|Secondary|Percentage of Subjects With a ≥3-Point Improvement From Baseline on Item 4 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire©|"The FLO-11 assess the subject's psychological and appearance-related impacts associated with facial lines. Item 4 is I look older than my actual age because of my facial lines with a range of possible scores from 0 = not at all to 10 = very much. Only subjects with baseline scores ≥ 3 are included in the analysis."|Baseline, Day 30|Intent-to-Treat: all randomized subjects with baseline scores ≥ 3 on Item 4 of the FLO-11|||Percentage of Subjects||95% Confidence Interval|Number
2592071|NCT02261493|Secondary|Percentage of Subjects With ≥20-Point Improvement From Baseline on the Impact Domain of the FLSQ Among Subjects With Baseline Score ≥ 20 Points|The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. The Impact Domain measures the subject's appearance-related and emotional impacts of treatment and is composed of 5 questions with a possible range of scores from 0 (worst) to 100 (best), using a transformed scale. Only subjects with baseline scores ≥ 20 are included in the analysis.|Baseline, Day 30|Intent-to-Treat: all randomized subjects with baseline scores ≥ 20 on the Impact Domain of the FLSQ|||Percentage of Subjects||95% Confidence Interval|Number
2592072|NCT02261493|Secondary|Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5|"The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. Item 5 on the FLSQ asks How satisfied are you with the effect your treatment had on your facial lines? Responses included: very satisfied, mostly satisfied, neither satisfied or dissatisfied, mostly dissatisfied, or very dissatisfied. The percentage of subjects reporting a score of mostly satisfied or very satisfied with treatment are reported."|Day 60|Intent-to-Treat: all randomized subjects with data reported at this time point|||Percentage of Subjects||95% Confidence Interval|Number
2592073|NCT02261493|Secondary|Percentage of Subjects With ≥1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest|The Investigator assessed the severity of the subject's forehead lines at rest using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 1-grade improvement assessed by the Investigator are reported.|Baseline, Day 30|Intent-to-Treat: all randomized subjects with at least a 1-grade improvement assessed by the Investigator on the FWS at rest|||Percentage of Subjects||95% Confidence Interval|Number
2592074|NCT02261493|Secondary|Percentage of Subjects With an Investigator Rating of None or Mild on the 4-Grade FWS for Forehead Line Severity at Maximum Eyebrow Elevation|"The Investigator assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with a score of none and mild are reported."|Day 30|"Intent-to-Treat: all randomized subjects with a score of none and mild on the FWS at maximum eyebrow elevation"|||Percentage of Subjects||95% Confidence Interval|Number
2592075|NCT02261493|Primary|Percentage of Subjects With ≥2-Grade Improvement From Baseline on Both the Investigator's and Subject's Facial Wrinkle Scale (FWS) Ratings of Forehead Line Severity at Maximum Eyebrow Elevation|The Investigator and subject each assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 2-grade improvement from baseline assessed by both the Investigator and the subject are reported.|Baseline, Day 30|Intent-to-Treat: all randomized subjects|||Percentage of Subjects||95% Confidence Interval|Number
2592076|NCT02261467|Secondary|Time to Retreatment Eligibility|Time to retreatment eligibility is defined as the number of days from treatment cycle 1 injection to the return to an Investigator FWS rating of moderate or severe at maximum eyebrow elevation. The FWS is a 4-grade scale, where 0=none, 1=mild, 2=moderate, and 3=severe. Only subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation on Day 30 are included in the analysis.|12 Months|Intent-to-Treat: all randomized subjects who achieved a ≥ 2-grade improvement on both the Investigator and subject FWS ratings at maximum eyebrow elevation|||Days||Standard Deviation|Median
2592217|NCT02260440|Secondary|Overall Survival (OS)|Overall Survival (OS) (median) was determined using the number of months measured from the initial date of treatment to the recorded date of death of participants.|Up to 2 years|Participants who received at least one dose of study therapy (median, 3 cycles; range, 1-8).|||months||95% Confidence Interval|Median
2592077|NCT02261467|Secondary|Percentage of Subjects With a ≥3-Point Improvement From Baseline on Item 4 of the 11-Point Facial Line Outcomes (FLO-11) Questionnaire©|"The FLO-11 assess the subject's psychological and appearance-related impacts associated with facial lines. Item 4 is I look older than my actual age because of my facial lines with a range of possible scores from 0 = not at all to 10 = very much. Only subjects with baseline scores ≥ 3 are included in the analysis."|Baseline, Day 30|Intent-to-Treat: all randomized subjects with baseline scores ≥ 3 on Item 4 of the FLO-11|||Percentage of Subjects||95% Confidence Interval|Number
2592078|NCT02261467|Secondary|Percentage of Subjects With ≥20-Point Improvement From Baseline on the Impact Domain of the FLSQ Among Subjects With Baseline Score ≥ 20 Points|The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. The Impact Domain measures the subject's appearance-related and emotional impacts of treatment and is composed of 5 questions with a possible range of scores from 0 (worst) to 100 (best), using a transformed scale. Only subjects with baseline scores ≥ 20 are included in the analysis.|Baseline, Day 30|Intent-to-Treat: all randomized subjects with baseline scores ≥ 20 on the Impact Domain of the FLSQ|||Percentage of Subjects||95% Confidence Interval|Number
2592079|NCT02261467|Secondary|Percentage of Subjects Reporting Mostly Satisfied or Very Satisfied on the 5-Point Facial Line Satisfaction Questionnaire (FLSQ) Item 5|"The FLSQ consists of 13 questions that assess subject satisfaction and appearance-related impacts associated with facial lines. Item 5 on the FLSQ asks How satisfied are you with the effect your treatment had on your facial lines? Responses included: very satisfied, mostly satisfied, neither satisfied or dissatisfied, mostly dissatisfied, or very dissatisfied. The percentage of subjects reporting a score of mostly satisfied or very satisfied with treatment are reported."|Day 60|Intent-to-Treat: all randomized subjects with data reported at this time point|||Percentage of Subjects||95% Confidence Interval|Number
2592080|NCT02261467|Secondary|Percentage of Subjects With ≥1-Grade Improvement From Baseline on the Investigator's FWS Rating of Forehead Line Severity at Rest|The Investigator assessed the severity of the subject's forehead lines at rest using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 1-grade improvement assessed by the Investigator are reported.|Baseline, Day 30|Intent-to-Treat: all randomized subjects with at least a 1-grade improvement assessed by the Investigator on the FWS at rest|||Percentage of Subjects||95% Confidence Interval|Number
2592081|NCT02261467|Secondary|Percentage of Subjects With an Investigator Rating of None or Mild on the 4-Grade FWS for Forehead Line Severity at Maximum Eyebrow Elevation|"The Investigator assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with a score of none and mild are reported."|Day 30|"Intent-to-Treat: all randomized subjects with a score of none and mild on the FWS at maximum eyebrow elevation"|||Percentage of Subjects||95% Confidence Interval|Number
2592082|NCT02261467|Primary|Percentage of Subjects With ≥2-Grade Improvement From Baseline on Both the Investigator's and Subject's Facial Wrinkle Scale (FWS) Ratings of Forehead Line Severity at Maximum Eyebrow Elevation|The Investigator and subject each assessed the severity of the subject's forehead lines at maximum eyebrow elevation using the 4-grade FWS, where 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of subjects with at least a 2-grade improvement from baseline assessed by both the Investigator and the subject are reported.|Baseline, Day 30|Intent-to-Treat: all randomized subjects|||Percentage of Subjects||95% Confidence Interval|Number
2592083|NCT02261428|Secondary|Presence of Blood on Catheter Immediately After Each Intervention|Immediately after each intervention recorded the presence or absence of blood on the catheter (Yes or No).|Within 2 seconds after catheter withdrawal.||||Catheters with presence of blood|||Number
2592084|NCT02261428|Secondary|Diastolic Blood Pressure Immediately After Each Intervention|Immediately after each intervention recorded the diastolic blood pressure (mmHg).|Within 2 seconds after catheter withdrawal.||||mmHg||Standard Deviation|Mean
2592085|NCT02261428|Secondary|Systolic Blood Pressure Immediately After Each Intervention|Immediately after each intervention recorded the systolic blood pressure (mmHg).|Within 2 seconds after catheter withdrawal.||||mmHg||Standard Deviation|Mean
2592086|NCT02261428|Secondary|Heart Rate Immediately After Intervention|Immediately after each intervention recorded the heart rate (beats per minute).|Within 2 seconds after catheter withdrawal.||||Βeats per minute||Standard Deviation|Mean
2592087|NCT02261428|Secondary|Respiratory Rate Immediately After Intervention|Recorded the respiratory rate (breaths per minute), immediately after intervention|Within 2 seconds after catheter withdrawal.||||Βreaths per minute||Standard Deviation|Mean
2592088|NCT02261428|Secondary|Time to Entering Trachea|We count the required time needed to insert catheter into trachea (seconds).|An average of 15 seconds|The 19 interventions with each catheter was used randomly|||Sec||Standard Deviation|Mean
2592089|NCT02261428|Primary|Number of Attempts Before Entering Trachea|We count the required attempts to insert catheter into trachea (number of attempts)|An average of 15 seconds||||Attempts||Standard Deviation|Mean
2592090|NCT02260986|Other Pre-specified|Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score to Week 16|ACQ-5 questionnaire was a validated questionnaire comprising of 5 questions for asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath, and wheeze. Participants were asked to rate their asthma symptoms during the previous week on a 7-point scale as 0=no impairment, 6=maximum impairment. ACQ-5 score was the mean of the 5 questions and range between 0 (totally controlled) and 6 (severely uncontrolled) (a higher score indicated lower asthma control). The ACQ-5 questionnaire was administered only to the participants with a medical history of asthma.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with ACQ-5 value at baseline.|||units on a scale||Standard Error|Least Squares Mean
2592173|NCT02260791|Other Pre-specified|Trough Adalimumab Concentration|Blood samples for the quantification of adalimumab concentration in serum were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12 and 20, and Week 24. Samples were taken prior to dosing (trough samples).|Week 2, Week 4, Week 12, Week 20, and Week 24|The Pharmacokinetic Analysis Set (PKAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and had at least 1 serum adalimumab concentration result after receiving randomised treatment.|||ng/mL||95% Confidence Interval|Geometric Least Squares Mean
2592091|NCT02260986|Other Pre-specified|Change From Baseline in Sinonasal Outcome Test (SNOT-22) Score to Week 16|The SNOT 22 was a validated measure of health related quality of life in sinonasal disease. It was a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease) (lower scores represent better health related quality of life). The SNOT-22 was administered only to participants with chronic inflammatory conditions of the nasal mucosa and/or paranasal sinuses.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Error|Least Squares Mean
2592092|NCT02260986|Secondary|Number of Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52|"Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = Infection and Infestations or SOC = Skin and Subcutaneous Tissue Disorders. Blinded adjudication was performed and finalized by the study medical monitor before database lock."|Baseline up to Week 52|All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.|||events|||Number
2592093|NCT02260986|Secondary|Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) Requiring Systemic Treatment From Baseline Through Week 52|"Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = Infection and Infestations or SOC = Skin and Subcutaneous Tissue Disorders. Blinded adjudication was performed and finalized by the study medical monitor before database lock."|Baseline up to Week 52|All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.|||percentage of participants|||Number
2592094|NCT02260986|Secondary|Number of Skin Infection TEAEs (Excluding Herpetic Infections) From Baseline Through Week 52|"Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = Infection and Infestations or SOC = Skin and Subcutaneous Tissue Disorders. Blinded adjudication was performed and finalized by the study medical monitor before database lock."|Baseline up to Week 52|All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.|||events|||Number
2592095|NCT02260986|Secondary|Percentage of Participants With Skin Infection Treatment Emergent Adverse Events (TEAEs) (Excluding Herpetic Infections) From Baseline Through Week 52|"Any untoward medical occurrence in a participants who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the first dose of study drug up to end of treatment at Week 52). Any TEAE included participants with both serious and non-serious AEs. Skin infection TEAEs were identified based on blinded adjudication of all reported TEAEs under the 2 primary System Organ Classes (SOC): SOC = Infection and Infestations or SOC = Skin and Subcutaneous Tissue Disorders. Blinded adjudication was performed and finalized by the study medical monitor before database lock."|Baseline up to Week 52|All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.|||percentage of participants|||Number
2592096|NCT02260986|Secondary|Number of Serious Treatment Emergent Adverse Events (TEAEs) Leading to Study Drug Discontinuation Through Week 52|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. A Serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline up to Week 52|All safety analysis were performed on SAF that included all randomized participants who received any study drug, and was analyzed as-treated.|||events|||Number
2592097|NCT02260986|Secondary|Number of Flares Through Week 52|Atopic dermatitis (AD) flares were defined as worsening of the disease that required escalation/intensification of AD treatment. Number of flares occurred in the participants starting from first dose through Week 52 were reported.|Baseline up to Week 52|All safety analysis were performed on safety analysis set (SAF) that included all randomized participants who received any study drug, and were analyzed as-treated.|||flares|||Number
2592098|NCT02260986|Secondary|Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 52|HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire is scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Error|Least Squares Mean
2592099|NCT02260986|Secondary|Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 52|The POEM was a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Error|Least Squares Mean
2592100|NCT02260986|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 52|The DLQI was a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Error|Least Squares Mean
2592101|NCT02260986|Secondary|Percent Change From Baseline in Global Individual Signs Score (GISS) to Week 52|Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Error|Least Squares Mean
2592102|NCT02260986|Secondary|Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 52|SCORAD was a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Error|Least Squares Mean
2592103|NCT02260986|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 52|BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||Percentage of BSA||Standard Error|Least Squares Mean
2592104|NCT02260986|Secondary|Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 52|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Error|Least Squares Mean
2592105|NCT02260986|Secondary|Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 2|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 2|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||percent change||Standard Error|Least Squares Mean
2592106|NCT02260986|Secondary|Proportion of Topical Atopic Dermatitis Medication-Free Days Through Week 52|Proportion of topical AD medication-free days through Week 52 was calculated as the number of days that a participant used neither topical corticosteroid (TCS)/ topical calcineurin inhibitors (TCI) nor system rescue therapy divided by the study days of each period.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||days||Standard Deviation|Mean
2592107|NCT02260986|Secondary|Percent Change From Baseline in Total Global Individual Signs Score (GISS) to Week 16|Individual components of the AD lesions (erythema, infiltration/ papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0= none, 1= mild, 2= moderate and 3= severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||percent change||Standard Error|Least Squares Mean
2592174|NCT02260791|Other Pre-specified|Percentage of Patients Developing Anti-drug Antibodies (ADAs)|Blood samples for the assessment of ADA activity were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12, and 24.|Baseline and last sampling day|The Safety Analysis Set was defined as the set of patients who received at least 1 dose of randomised treatment. The Safety Analysis Set was used for all safety analyses. Patient safety data were analysed according to treatment actually received.|||percentage of patients|||Number
2592108|NCT02260986|Secondary|Change From Baseline in Hospital Anxiety Depression Scale (HADS) to Week 16|HADS is a fourteen item scale. Seven of the items relate to anxiety and seven items relate to depression. Each item on the questionnaire scored from 0 (minimum score) - 3 (maximum score) and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported as 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||units on a scale||Standard Error|Least Squares Mean
2592109|NCT02260986|Secondary|Change From Baseline in Patient Oriented Eczema Measure (POEM) to Week 16|The POEM was a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||units on a scale||Standard Error|Least Squares Mean
2592110|NCT02260986|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) to Week 16|The DLQI was a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The 10 questions assessed QOL over the past week, with an overall scoring of 0 (absent disease) to 30 (severe disease); a high score was indicative of a poor QOL.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||units on a scale||Standard Error|Least Squares Mean
2592111|NCT02260986|Secondary|Percent Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score to Week 16|SCORAD was a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||percent change||Standard Error|Least Squares Mean
2592112|NCT02260986|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis to Week 16|BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||Percentage of BSA||Standard Error|Least Squares Mean
2592113|NCT02260986|Secondary|Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score to Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||percent change||Standard Error|Least Squares Mean
2592114|NCT02260986|Secondary|Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||units on a scale||Standard Error|Least Squares Mean
2592115|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 2|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 2 were reported.|Baseline to Week 2|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.|||percentage of participants|||Number
2592116|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 4|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 4 were reported.|Baseline to Week 4|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.|||percentage of participants|||Number
2605753|NCT02107014|Primary|Change in IL-12p40 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2592117|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 24|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 24 were reported.|Baseline to Week 24|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.|||percentage of participants|||Number
2592118|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥3.|||percentage of participants|||Number
2592119|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 52|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 52 were reported.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.|||percentage of participants|||Number
2592120|NCT02260986|Secondary|Percent Change From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||percent change||Standard Error|Least Squares Mean
2592121|NCT02260986|Secondary|Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 52|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 52.|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||percentage of participants|||Number
2592122|NCT02260986|Secondary|"Percentage of Participants With Investigator's Global Assessment (IGA) Score of 0 or 1 and Reduction From Baseline of ≥2 Points at Week 52"|"IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score of 0 or 1 and a reduction from baseline of ≥2 points at Week 52 were reported."|Baseline to Week 52|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with available data for this endpoint.|||percentage of participants|||Number
2592123|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥3 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥3 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥3.|||percentage of participants|||Number
2592162|NCT02260817|Secondary|Primary Treatment Modality of Arm 2 Participants|"An accounting of the primary treatment modalities undergone by the participants in Arm 2 prior to their involvement in the trial will be reported.~Modalities reported below are:~Androgen Deprivation Therapy (ADT) External Beam Radiation Therapy (EBRT) Brachytherapy Cryoablation Cystoprostatectomy Intensity-Modulated Radiation Therapy (IMRT) Radical Prostatectomy (RP)"|The participants' primary treatment data was collected upon study enrollment (approximately 1 week into study)|Only data collected from Arm 2 Participants.|||Participants|||Count of Participants
2592124|NCT02260986|Secondary|Percentage of Participants With Improvement (Reduction ≥4 Points) of Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Participants achieving a reduction of ≥4 points from baseline in weekly average of peak daily pruritus NRS score at Week 16 were reported.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized). Here, number of participants analyzed = participants with baseline peak pruritus NRS score ≥4.|||percentage of participants|||Number
2592125|NCT02260986|Secondary|Percentage of Participants With Eczema Area and Severity Index-75 (EASI-75) (≥75% Improvement From Baseline) at Week 16|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 16.|Baseline to Week 16|All efficacy analyses were performed on the FAS, which included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).|||percentage of participants|||Number
2592126|NCT02260986|Primary|"Percentage of Participants With Investigator's Global Assessment (IGA) Score of 0 or 1 and Reduction From Baseline of ≥2 Points at Week 16"|"IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score 0 or 1 and a reduction from baseline of ≥2 points at Week 16 were reported."|Baseline to Week 16|All efficacy analyses were performed on the Full Analysis Set (FAS), which included all randomized participants. Efficacy analyses were based on the treatment allocated by interactive voice response system/ interactive web response system (IVRS/IWRS) at randomization (as randomized).|||percentage of participants|||Number
2592127|NCT02260934|Secondary|Frequency of Specific Adverse Events of Interest By Participant, By Week 96|"Number of participants who experienced ≥Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.~Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0."|Week 96|The safety population includes all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2592128|NCT02260934|Secondary|Frequency of Specific Adverse Events of Interest By Event by Week 96|"Number of ≥ Grade 2 specific treatment-emergent adverse events (AEs) of interest. Grade 2 or higher AEs were classified according to the listed categories of interest based on the study team's review of the AEs.~Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~The severity of AEs was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03: June 14, 2010). AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0."|Week 96|The safety population includes all participants who received at least one dose of study treatment.|||Events|||Number
2592129|NCT02260934|Secondary|Percentage of Participants Hypocomplementemic for Complement Component C4 at Week 24, Week 48, and Week 96|"The percentage of participants who were hypocomplementemic for complemen component C4, defined as a C4 level <10 mg/dL.~Serum C4 complement is a protein which can be measured in the blood. Low blood levels of C4 are common in those with active lupus."|Week 24, Week 48 and Week 96|"The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.~Confidence intervals were calculated using Clopper-Pearson method."|||percentage of participants||95% Confidence Interval|Number
2592130|NCT02260934|Secondary|Percentage of Participants Hypocomplementemic for Complement Component C3 at Week 24, Week 48, and Week 96|"The percentage of participants who were hypocomplementemic for complement component, C3, defined as a C3 level <90 mg/dL.~Serum C3 complement is a protein which can be measured in the blood. Low blood levels of C3 are common in those with active lupus."|Week 24, Week 48 and Week 96|"The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.~Confidence intervals were calculated using Clopper-Pearson method."|||percentage of participants||95% Confidence Interval|Number
2592131|NCT02260934|Secondary|Percentage of Participants With an Negative Anti-dsDNA Result at Week 24, Week 48, and Week 96|"The percentage of participants who were anti-double stranded DNA (anti-dsDNA) negative, defined as having anti-dsDNA levels <30 IU/mL.~Anti-dsDNA levels are associated with systemic lupus erythematosus disease activity."|Week 24, Week 48 and Week 96|"The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.~Confidence intervals were calculated using Clopper-Pearson method."|||percentage of participants||95% Confidence Interval|Number
2592264|NCT02259348|Post-Hoc|Mean of Days to Absolute Neutrophil Count (ANC) Engraftment|ANC engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm^3 with evidence of donor cell engraftment.|Day 42 post transplantation||||days||Standard Deviation|Mean
2592132|NCT02260934|Secondary|Count of Participants: Frequency of Non-renal Flares by Week 96|"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity."|Week 96|The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.|||Participants|||Count of Participants
2592133|NCT02260934|Secondary|Count of Participants: Frequency of Non-renal Flares by Week 48|"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity."|Week 48|The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.|||Participants|||Count of Participants
2592134|NCT02260934|Secondary|Count of Participants: Frequency of Non-renal Flares by Week 24|"Count of participants who experienced non-renal flares, defined as any new A finding in a non-renal organ system in the British Isles Lupus Assessment Group (BILAG) assessment. A BILAG A finding represents a significant increase in, or a new manifestation of, disease activity."|Week 24|The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.|||Participants|||Count of Participants
2592135|NCT02260934|Secondary|Percentage of Participants With Treatment Failure by Week 24, Week 48, and Week 96|The percentage of participants who met the criteria for treatment failure, defined by withdrawal from the protocol treatment regimen due to worsening nephritis, infection, or study medication toxicity.|Week 24, Week 48 and Week 96|"The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.~Confidence intervals were calculated using Clopper-Pearson method."|||percentage of participants||95% Confidence Interval|Number
2592136|NCT02260934|Secondary|Percentage of Participants With a Sustained Complete Response|"The percentage of participants who achieved a sustained complete response, defined as a complete response achieved at Week 48 and Week 96.~Complete response was defined as meeting all of the following criteria:~Urine protein-to-creatinine ratio (UPCR) < 0.5, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions."|Week 48, Week 96|"The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.~Confidence intervals were calculated using Clopper-Pearson method."|||percentage of participants||95% Confidence Interval|Number
2592137|NCT02260934|Secondary|Percentage of Participants With an Overall Response at Week 24, Week 48, and Week 96|"The percentage of participants who achieved an overall response, defined as meeting all of the following criteria:~>50% improvement in the urine protein-to-creatinine ratio (UPCR) from study entry, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions."|Week 24, Week 48 and Week 96|"The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.~Confidence intervals were calculated using Clopper-Pearson method."|||percentage of participants||95% Confidence Interval|Number
2592138|NCT02260934|Secondary|Percentage of Participants With a Complete Response at Week 24, Week 48, and Week 96|"The percentage of participants who achieved a complete response, defined as meeting all of the following criteria:~Urine protein-to-creatinine ratio (UPCR) < 0.5, based on a 24-hour collection;~Estimated glomerular filtration rate (eGFR) ≥ 120 ml/min/1.73 m^2 calculated by the CKD-EPI formula or, if < 120 ml/min/1.73 m^2, then > 80% of eGFR at entry; and~Prednisone dose tapered to 10 mg/day and adherence to prednisone dosing provisions."|Week 24, Week 48 and Week 96|"The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.~Confidence intervals were calculated using Clopper-Pearson method."|||percentage of participants||95% Confidence Interval|Number
2592139|NCT02260934|Secondary|Percentage of Participants With Grade 4 Hypogammaglobulinemia by Week 24, Week 48, and Week 96|The percentage of participants who experienced Grade 4 hypogammaglobulinemia, defined as having a serum Immunoglobulin G (IgG) level < 300 mg/dL. Severity of adverse events (AEs) was classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010).|Week 24, Week 48 and Week 96|"The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.~Confidence intervals were calculated using Clopper-Pearson method."|||percentage of participants||95% Confidence Interval|Number
2592140|NCT02260934|Secondary|Percentage of Participants With B Cell Reconstitution at Week 24, Week 48 and Week 96|"The percentage of participants who achieved B cell reconstitution, defined as a peripheral blood total B cell count ≥ to the baseline count or the lower limit of normal, whichever was lower. Note: B cell depletion was expected to occur in this study between Weeks 0 and 4, after initiation of rituximab and cyclophosphamide.~Normal peripheral blood B Cell count: 107 to 698 cells/µL."|Week 24, Week 48 and Week 96|"The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.~Confidence intervals were calculated using Clopper-Pearson method."|||Percentage of Participants||95% Confidence Interval|Number
2594348|NCT02233738|Secondary|SF-12 Health Survey Physical Summary Score at 1 Month|Physical summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health|1 month||||score on a scale||Standard Deviation|Mean
2592141|NCT02260934|Primary|Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96|"The percentage of participants who experienced at least one Grade 3 or higher treatment-emergent infectious adverse event. The severity of adverse events (AEs) was classified into grades using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, v4.03:June 14, 2010). Treatment-emergent AEs are those:~with an onset date on or after the first dose of study medication,~with onset before first dose but that worsened in severity after first dose, and~for which the start of the AE in relation to the start of study medication could not be established.~AEs were classified by system organ class and preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA) version 17.0. Grade 3 or higher AEs were classified infectious based on the study team's review of the MedDRA body systems and preferred terms of the AEs."|Week 0 to Week 96|"The modified intent-to-treat population includes all randomized participants who received 1 dose of Solumedrol, 1 dose of rituximab, 1 dose of cyclophosphamide, and, if in the Rituximab/Cyclophosphamide/Belimumab (RCB) arm, 1 dose of belimumab.~Confidence intervals were calculated using Clopper-Pearson method."|||percentage of participants||95% Confidence Interval|Number
2592142|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Fatigue|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of fatigue recorded on the VRC during the first 14 days after vaccination was recorded.|Up to 14 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.|||Percentage of participants|||Number
2592143|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Headache|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of headache recorded on the VRC during the first 14 days after vaccination was recorded.|Up to 14 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.|||Percentage of participants|||Number
2592144|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Arthralgia|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of arthralgia recorded on the VRC during the first 14 days after vaccination was recorded.|Up to 14 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.|||Percentage of participants|||Number
2592145|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Myalgia|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of myalgia recorded on the VRC during the first 14 days after vaccination was recorded.|Up to 14 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.|||Percentage of participants|||Number
2592146|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Pyrexia|Percentage of participants with an adverse event of pyrexia (>=37.5°C, oral) recorded on the VRC during the first 5 days after vaccination was recorded.|Up to 5 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.|||Percentage of participants|||Number
2592147|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Injection-site Pain|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site pain recorded on the VRC during the first 5 days after vaccination was recorded.|Up to 5 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.|||Percentage of participants|||Number
2592148|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Injection-site Swelling|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site swelling recorded on the VRC during the first 5 days after vaccination was recorded.|Up to 5 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.|||Percentage of participants|||Number
2592149|NCT02260882|Secondary|Percentage of Participants With an Adverse Event of Injection-site Erythema|An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Percentage of participants with an adverse event of injection-site erythema recorded on the Vaccine Report Card (VRC) during the first 5 days after vaccination was recorded.|Up to 5 days after vaccination|All Subjects as Treated set: all participants who received study vaccine.|||Percentage of participants|||Number
2605754|NCT02107014|Primary|Change in IL-10 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2592150|NCT02260882|Secondary|Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Primary Vaccination|Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.|Baseline and 4 weeks after primary vaccination|Per Protocol Set: all participants in the Primary Vaccination Group except those with a protocol deviation, including those with blood collection outside the protocol-specified window|||Geometric Mean Fold Rise||95% Confidence Interval|Geometric Mean
2592151|NCT02260882|Primary|Change From Baseline in Serotype-Specific Antibody Geometric Mean Concentration at 4 Weeks After Revaccination|Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Geometric mean antibody concentrations (GMCs) were calculated at Baseline and 4 weeks postvaccination. Geometric Mean Fold Rise was the GMC at 4 weeks after vaccination minus the GMC at Baseline.|Baseline and 4 weeks after revaccination|Per Protocol Set: all participants in the Revaccination Group except those with a protocol deviation, including those with blood collection outside the protocol-specified window.|||Geometric Mean Fold Rise||95% Confidence Interval|Geometric Mean
2592152|NCT02260817|Secondary|ADT (Androgen Deprivation Therapy) in Participant at PET Imaging|An accounting of whether the participants of Arm 2 have undergone androgen deprivation therapy (ADT).|The participants' participation in ADT was collected upon study enrollment (approximately 1 week into study)|Only the Arm 2 participants data is reported. Note: ADT information was not collected for 2 participants.|||Participants|||Count of Participants
2592153|NCT02260817|Secondary|Median PSA Velocity of Arm 2 Participants at PET Imaging|The median PSA velocity (measured in ng/mL/month) of the Arm 2 participants will be reported.|The participants' PSA velocity was collected upon study enrollment (approximately 1 week into study)|Only data collected from Arm 2 participants is reported. Note: PSA velocity was not collected for 3 participants.|||ng/mL/month||Full Range|Median
2592154|NCT02260817|Secondary|Median PSA Doubling Time of Arm 2 Participants at PET Imaging|The median of the time, measured in months that an Arm 2 participant's PSA has doubled from initial diagnosis to PSA measured at study enrollment.|The participants' PSA doubling time was collected upon study enrollment (approximately 1 week into study)|Only data collected from Arm 2 participants is reported. Note: PSA doubling time (in months) was not collected for 3 participants.|||months||Full Range|Median
2592155|NCT02260817|Secondary|Median PSA of Arm 2 Participant at PET Imaging|The median of the PSA of Arm 2 participants at study entry will be reported as nanograms of PSA per milliliter (ng/mL) of blood|The participants' PSA was collected upon study enrollment (approximately 1 week into study)|only data collected for Arm 2 participants.|||ng/ml of blood||Full Range|Median
2592156|NCT02260817|Secondary|Median Age of Arm 2 Participant at PET Imaging|The median age (at time of study) of participants of Arm 2 will be reported in years.|The participants' age at study entry was collected upon study enrollment (approximately 1 week into study)|Only data collected from Arm 2 participants is reported.|||years||Full Range|Median
2592157|NCT02260817|Secondary|Median Months to Biochemical Relapse of Arm 2 Participants|The median of the Arm 2 participants' data between initial treatment and biochemical relapse, occurring prior to study enrollment, measured in months, will be reported.|The participants' biochemical relapse data was collected upon study enrollment (approximately 1 week into study)|only data from Arm 2 participants is collected. Note: Biochemical Relapse Data was not collected for 2 participants.|||months||Full Range|Median
2592158|NCT02260817|Secondary|Additional Treatment and Type for Arm 2 Participants|"A census of the additional treatments undergone by participants prior to enrollment in the study, if undergone, for the participants of Arm 2 will be reported.~None Androgen Deprivation Therapy (ADT) Radiation Therapy (RT) Electron Beam Radiation Therapy (EBRT) Lycopene (herbal treatment) Salvage Radiation Therapy (RT) Salvage Radical Prostatectomy (RP) Adjuvant Radiation Therapy (RT) Bilateral Pelvis Lymph Node Dissection"|The participants' additional primary treatment data was collected upon study enrollment (approximately 1 week into study)|only data from Arm 2 Participants is collected. Note: Additional Treatment was not reported for 1 participant.|||Participants|||Count of Participants
2592159|NCT02260817|Secondary|Primary Positive Lymph Node Ratio of Arm 2 Participants|"A census of the positive lymph node ratio, defined as ratio of positive lymph nodes to all lymph nodes removed, for the participants of Arm 2 will be reported.~The N refers to the the number of nearby lymph nodes that have cancer. NX: Cancer in nearby lymph nodes cannot be measured. N0: There is no cancer in nearby lymph nodes. N1, N2, N3: Refers to the number and location of lymph nodes that contain cancer. The higher the number after the N, the more lymph nodes that contain cancer."|The participants' primary positive lymph note ratio was collected upon study enrollment (approximately 1 week into study)|Only data collected from Arm 2 participants. Note: Primary Positive Lymph Node Ratio was not collected for 26 participants.|||Participants|||Count of Participants
2592160|NCT02260817|Secondary|Primary Surgical Margins of Arm 2 Participants|"A census of the primary surgical margins of participants in Arm 2 will reported.~The surgical margins are the set of surfaces that were cut by the surgeon in order to remove the specimen from the body.~Positive Margin: surgical margins with disease present. Negative Margin: surgical margins with no disease present."|The participants' primary surgical margins data was collected upon study enrollment (approximately 1 week into study)|Only data for Arm 2 participants was collected. Note: Primary Surgical Margins were not collected for 26 participants.|||Participants|||Count of Participants
2592161|NCT02260817|Secondary|Pathological Stage (pT) of Prostate Cancer (PC) of Arm 2 Participants|"The pathological stage of PC at primary diagnosis for Arm 2 participants was collected. pT is based on how different from normal the cells in samples of tissue recovered from surgery look under a microscope.~T1: PC is too small to be seen on a scan or felt during prostate examination~T1a: PC is in < 5% of removed tissue~T1b: PC is in > 5% or more of removed tissue~T1c: PC is found by biopsy~T2: PC is completely inside prostate~T2a: PC is in only half of one side of prostate~T2b: PC is in more than half of one side of prostate, but not both sides~T2c: PC is in both sides but is still inside prostate~T3: PC has broken through the capsule of prostate~T3a: PC has broken through the capsule of prostate~T3b: PC has spread into seminal vesicles~T4: PC has spread into other nearby body organs"|The participants' primary pathological staging data was collected upon study enrollment (approximately 1 week into study)|Only data collected from Arm 2 participants. Note: Pathological Stage data not collected for 26 patients.|||Participants|||Count of Participants
2592163|NCT02260817|Secondary|Median Primary Biopsy Gleason Score of Arm 2 Participants|"The median primary Biopsy Gleason Score for the Arm 2 participants' will be reported.~The Gleason Score is the grading system used to determine the aggressiveness of prostate cancer. Typical Gleason Scores range from 6-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly.~Gleason scores 2-4 are typically found in smaller tumors located in the transitional zone (around the urethra).~The majority of treatable/treated cancers are of Gleason scores 5 - 7 and are detected due to biopsy after abnormal digital rectal exam or prostate specific antigen evaluation. The cancer is typically located in the peripheral zone usually the posterior portion.~Tumors with Gleason scores 8-10 tend to be advanced neoplasms that are unlikely to be cured."|The participants' primary Biopsy Gleason Score data was collected upon study enrollment (approximately 1 week into study)|Only data collected from Arm 2 Participants. Note: Biopsy Gleason Grade was not reported for 1 participant.|||units on a scale||Full Range|Median
2592164|NCT02260817|Secondary|Clinical T (cT) Stage of Arm 2 Participants|"An accounting of the approximate clinical (pre-treatment) stage for the Arm 2 participants. Clinical staging is based on the results of tests done before surgery.~T1: PC is too small to be seen on a scan or felt during prostate examination~T1a: PC is in < 5% of removed tissue~T1b: PC is in > 5% or more of removed tissue~T1c: PC is found by biopsy~T2: PC is completely inside prostate~T2a: PC is in only half of one side of prostate~T2b: PC is in more than half of one side of prostate, but not both sides~T2c: PC is in both sides but is still inside prostate~T3: PC has broken through the capsule of prostate~T3a: PC has broken through the capsule of prostate~T3b: PC has spread into seminal vesicles~T4: PC has spread into other nearby body organs"|The participants' clinical stage data was collected upon study enrollment (approximately 1 week into study)|Only data from Arm 2 participants' was collected. Note: Clinical Staging for 4 participants was not reported.|||Participants|||Count of Participants
2592165|NCT02260817|Secondary|Median PSA at Diagnosis of Arm 2 Participants|The Prostate-Specific Antigen (PSA) measurement of participants at their original prostate cancer diagnosis was collected at entry to this trial. It is reported as nanograms of PSA per milliliter (ng/mL) of blood. The Median of all reported PSAs is reported here.|The participants' primary PSA at diagnosis was collected upon study enrollment (approximately 1 week into study)|Only Arm 2 participants' data was collected. *Note: 4 participants' PSA was not reported.|||ng/ml||Full Range|Median
2592166|NCT02260817|Secondary|Median Age at Primary Treatment|The median age at primary treatment for Arm 2 participants.|The participants' age at primary treatment was collected upon study enrollment (approximately 1 week into study)|Only Arm 2 participants' data was collected.|||years||Full Range|Median
2592167|NCT02260817|Primary|Count of Participants With Positive or Negative PET, CT, or MRI Modalities Resulting in Prostate Cancer (PCa) Confirmation|Comparison of the results of participants' imaging modalities and whether those imaging modalities resulted in confirmation of Prostate Cancer (PCa). This Outcome is only measured for Arm 2.|Approximately 1 day post-scan for patient results|This population only includes those Arm 2 participants with positive PET imaging.|||Participants|||Count of Participants
2592168|NCT02260817|Primary|Negative Predictive Value (NPV) of 11C Choline PET Imaging Scans|"The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for the images' negative predictive value.~Negative Predictive Value of 11C-choline PET/CT and MRI will be calculated as True Negative / (True Negative + False Negative).~This Outcome is only measured for Arm 2."|Approximately 1 day post-scan for patient results|Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.|||Probability of being disease-free (%)|||Number
2592169|NCT02260817|Primary|Positive Predictive Value (PPV) of 11C Choline PET Imaging Scans|"The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for the images' positive predictive value.~Positive Predictive Value of 11C-choline PET/CT and MRI will be calculated as True Positive / (True Positive + False Positive).~This Outcome is only measured for Arm 2."|Approximately 1 day post-scan for patient results|Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.|||Probability of disease (%)|||Number
2592170|NCT02260817|Primary|Specificity of 11C Choline PET Imaging Scans|"The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for imaging specificity.~Specificity of 11C-choline PET/CT and MRI will be calculated as True Negative / (True Negative + False Positive).~This Outcome is only measured and reported for Arm 2."|Approximately 1 day post-scan for patient results|Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.|||% correctly identified negatives|||Number
2592171|NCT02260817|Primary|Sensitivity of 11C Choline PET Imaging Scans|"The results of the population's 11C-choline PET CT scans and MRI scans will be evaluated for imaging sensitivity.~Sensitivity of 11C-choline PET/CT and MRI will be calculated as True Positive / (True Positive + False Negative).~This Outcome is only measured for Arm 2 of this study."|Approximately 1 day post-scan for patient results|Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.|||% of correctly identified positives|||Number
2592172|NCT02260817|Primary|Evidence of Metastatic Prostate Cancer|"The CT and MRI images will be evaluated for evidence of metastatic prostate cancer. This Outcome is only measured for Arm 2 of this study.~True Positive: True positives will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images confirmed with biopsy, surgical pathology, or by response to treatment with androgen suppression or other medical or radiation therapy.~True Negative: True negatives will consist of negative images.~False Positive: False positive will consist of evidence of metastatic prostate cancer on conventional CT or MRI images or on 11C-choline PET/CT or MRI images, but without corresponding confirmation from biopsy, surgical pathology or response to treatment.~False Negative: False negative will consist of negative images, but with positive biopsy, surgical pathology or a response to treatment."|After 11C-choline PET CT scan and MRI scans, approximately 1 day. If surgery or response to treatment required to evaluate, approximately 1 to 3 months.|Only those participants of Arm 2 not excluded due to reasons listed in Population Flow were analyzed for this outcome.|||Participants|||Count of Participants
2592266|NCT02259348|Secondary|Incidence and Severity of Chronic GvHD|"The cumulative incidence of chronic GvHD will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The severity of chronic GvHD will be described. Chronic GvHD was evaluated using NIH Consensus Global Severity Scoring. The number of participants with incidence by severity is given."|one year post transplantation||||participants|||Number
2592175|NCT02260791|Secondary|DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR)|The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-ESR assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum ESR, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.|Baseline, Week 12 and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||units on a scale||Standard Deviation|Mean
2592176|NCT02260791|Secondary|DAS28-CRP Score Over Time|The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.|Baseline and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||units on a scale||Standard Deviation|Mean
2592177|NCT02260791|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ-DI is a 20-question, self-administered instrument that measures the patient's functional ability on a 4-level difficulty scale (0 to 3, with 0 representing normal or no difficulty and 3 representing inability to perform). Eight categories of functioning are included: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. This scale is sensitive to change and is a good predictor of future disability. HAQ-DI is a value of the individual ACR core set variables.|Baseline and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||units on a scale||Standard Deviation|Mean
2592178|NCT02260791|Secondary|Patient's Assessment of Pain|"An injection site pain visual analogue score (VAS) will be administered to the patient. To determine the extent of the pain, patients will be asked to place a small vertical mark on a horizontal scale from 0 to 100, the ends of which are labelled with the extreme responses to be measured (No pain at 0 and Intolerable pain at 100). Patient's assessment of pain is a value of the individual ACR core set variables."|Baseline and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||units on a scale||Standard Deviation|Mean
2592179|NCT02260791|Secondary|Physician Assessment of Disease Activity|Physician assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scale (ranging from very low (0) to very high (100)). The physician assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.|Baseline and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||units on a scale||Standard Deviation|Mean
2592180|NCT02260791|Secondary|Patient Assessment of Disease Activity|Patient assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scales (ranging from very well (0) to extremely bad (100)).The patient assessment of disease activity VAS will contribute to the calculation of the DAS28 score. The patient assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.|Baseline and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||units on a scale||Standard Deviation|Mean
2592181|NCT02260791|Secondary|Analysis of Serum C-Reactive Protein (CRP) Concentration|Analysis of serum C-Reactive Protein (CRP) concentrations for inclusion in the ACR20/50/70 and DAS28-CRP scores was performed by a central laboratory. Elevation of CRP is a nonspecific marker of inflammation. Values above 10 mg/L were considered to be abnormally high. Decrease in level of CRP indicates reduction in inflammation.|Baseline and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||mg/L||Standard Deviation|Mean
2592182|NCT02260791|Secondary|Tender Joint Count|Counts of tender joints from amongst 68 selected joints were performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68 with higher scores indicating severe disease.Tender joint count is a value of the individual ACR core set variables.|Baseline and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||Count / Score||Standard Deviation|Mean
2592194|NCT02260648|Secondary|Percent Change From Baseline to Week 12 in High-Density Lipoprotein Cholesterol (HDL-C)|The MMRM was used for the LS Mean estimates at Week 12 for HDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect, and treatment-by-visit interaction as fixed effects, and participant as a random effect.|Baseline, Week 12|All participants who received at least one dose of study drug.|||percent change in HDL-C||Standard Error|Least Squares Mean
2592183|NCT02260791|Secondary|Swollen Joint Count|Counts of swollen joints from amongst 66 selected joints performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66 with higher scores indicating severe disease. Swollen joint count is a value of the individual ACR core set variables.|Baseline and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||Count / Score||Standard Deviation|Mean
2592184|NCT02260791|Secondary|ACR70 Response Rates Over Time|"An ACR70 response meant that the patient achieved a 70% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.~Acute phase reactant (CRP)~Patient global assessment of disease activity~Physician global assessment of disease activity~Patient pain scale~Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])"|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||percentage of responders||95% Confidence Interval|Number
2592185|NCT02260791|Secondary|ACR50 Response Rates Over Time|"An ACR50 response meant that the patient achieved a 50% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.~Acute phase reactant (CRP)~Patient global assessment of disease activity~Physician global assessment of disease activity~Patient pain scale~Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI])"|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||percentage of responders||95% Confidence Interval|Number
2592186|NCT02260791|Secondary|ACR20 Response Rates Over Time|"An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.~Acute phase reactant (CRP)~Patient global assessment of disease activity~Physician global assessment of disease activity~Patient pain scale~Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])"|Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment.Patients were analysed according to the randomised treatment in the primary analysis.|||percentage of responders||95% Confidence Interval|Number
2592187|NCT02260791|Secondary|Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score|The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The DAS28-CRP is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.|Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||units on a scale||Standard Deviation|Mean
2592188|NCT02260791|Primary|American College of Rheumatology (ACR) 20 Response Rate|"The primary efficacy endpoint was the ACR20 response rate at Week 24.~An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below.~Acute phase reactant (CRP)~Patient global assessment of disease activity~Physician global assessment of disease activity~Patient pain scale~Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI])"|Week 24|The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.|||Percentage of participants||95% Confidence Interval|Number
2592189|NCT02260648|Secondary|Percent Change From Baseline to Week 12 in Apolipoprotein B|The ANCOVA model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.|Baseline, Week 12|All participants who received at least one dose of study drug.|||percent change in Apolipoprotien B||Standard Error|Least Squares Mean
2592190|NCT02260648|Secondary|Percent Change From Baseline to Week 12 in Apolipoprotein A-I|The ANCOVA model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.|Baseline, Week 12|All participants who received at least one dose of study drug.|||percent change in Apolipoprotein A-I||Standard Error|Least Squares Mean
2592191|NCT02260648|Secondary|Percent Change From Baseline to Week 12 in Lipoprotein-a|The analysis of covariance (ANCOVA) model using last observation carried forward (LOCF) was applied to analyze percent changes from baseline.|Baseline, Week 12|All participants who received at least one dose of study drug.|||percent change in Lipoprotein-a||Standard Error|Least Squares Mean
2592192|NCT02260648|Secondary|Percent Change From Baseline to Week 12 in Non HDL-C|The MMRM was used for the LS Mean estimates at Week 12 for Non HDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect.|Baseline, Week 12|All participants who received at least one dose of study drug.|||percent change in non HDL-C||Standard Error|Least Squares Mean
2592193|NCT02260648|Secondary|Percent Change From Baseline to Week 12 in LDL-C (Direct)|The MMRM was used for the LS Mean estimates at Week 12 for LDL-C (direct) adjusting for baseline as response variables, baseline measurement as a covariate, treatment, visit, and treatment-by-visit interaction as fixed effects, and participant as a random effect.|Baseline, Week 12|All participants who received at least one dose of study drug.|||percent change in LDL-C (Direct)||Standard Error|Least Squares Mean
2592195|NCT02260648|Primary|Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification|The mixed-effects model for repeated measures (MMRM) was used for the Least Squares Mean (LS Mean) estimates at Week 12 for LDL-C adjusting for baseline as response variables, baseline measurement as a covariate, treatment, Visit (4,5,6, or 7), and treatment-by-visit interaction as fixed effects, and participant as a random effect.|Baseline, Week 12|All participants who received at least one dose of study drug.|||percent change in LDL-C||Standard Error|Least Squares Mean
2592196|NCT02260635|Secondary|Percent Change From Baseline in Apolipoprotein B|LS Mean from ANCOVA model adjusted for baseline and treatment.|Baseline, Week 12, Week 52|All randomized participants receiving at least 1 dose of study drug with evaluable Apolipoprotein B values at baseline, and at least 1 post-baseline measurement.|||percent change in Apolipoprotein B||Standard Error|Least Squares Mean
2592197|NCT02260635|Secondary|Percent Change From Baseline in Apolipoprotein A-I|LS Mean from ANCOVA model adjusted for baseline and treatment.|Baseline, Week 12, Week 52|All randomized participants receiving at least 1 dose of study drug with evaluable Apolipoprotein A-I values at baseline, and at least 1 post-baseline measurement.|||percent change in Apolipoprotein A-I||Standard Error|Least Squares Mean
2592198|NCT02260635|Secondary|Percent Change From Baseline in Lipoprotein-a|LS Mean from analysis of covariance (ANCOVA) model adjusted for baseline and treatment.|Baseline, Week 12, Week 52|All randomized participants receiving at least 1 dose of study drug with evaluable Lipoprotein-a values at baseline, and at least 1 post-baseline measurement.|||percent change in Lipoprotein-a||Standard Error|Least Squares Mean
2592199|NCT02260635|Secondary|Percent Change From Baseline in Non HDL-C|LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.|Baseline, Week 12|All randomized participants receiving at least 1 dose of study drug with evaluable Non HDL-C values at baseline, and at least 1 post-baseline measurement.|||percent change in non HDL-C||Standard Error|Least Squares Mean
2592200|NCT02260635|Secondary|Percent Change From Baseline in LDL-C (Direct)|LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.|Baseline, Week 12|All randomized participants receiving at least 1 dose of study drug with evaluable LDL-C direct values at baseline, and at least 1 post-baseline measurement.|||percent change of LDL-C direct||Standard Error|Least Squares Mean
2592201|NCT02260635|Secondary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C)|LS mean using MMRM adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.|Baseline, Week 12|All randomized participants receiving at least 1 dose of study drug with evaluable HDL-C values at baseline, and at least 1 post-baseline measurement.|||percent change of HDL-C||Standard Error|Least Squares Mean
2592202|NCT02260635|Primary|Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) Measured by Beta Quantification|Least Square Mean (LS mean) using mixed model repeated measures (MMRM) adjusted for baseline, treatment, visit , and treatment*visit, where the participant is a random effect.|Baseline, Week 12|All randomized participants receiving at least 1 dose of study drug with evaluable LDL-C values measured by beta quantification at baseline, and at least 1 post-baseline measurement.|||percent change in LDL-C||Standard Error|Least Squares Mean
2592203|NCT02260622|Secondary|Biomarkers|Biological plausibility by measuring coagulation changes and SMC proliferation markers within 7 and 90 days based on the following markers: D-dimer, soluble CD40/44 ligands, and ERK 1/2|90 days|Not performed.||||||
2592204|NCT02260622|Secondary|Minor Bleeding|Cumulative clinically relevant or minor bleeding between day 1 and day 90|90 days||||Participants|||Count of Participants
2592205|NCT02260622|Secondary|Major Bleeding|Cumulative rate of major bleeding between day 1 and day 90|90 days||||Participants|||Count of Participants
2592206|NCT02260622|Secondary|MACE|Cumulative rate of major adverse cardiovascular events between day 1 and final visit|1 year||||Participants|||Count of Participants
2592207|NCT02260622|Secondary|Peri-procedure Death|The number of patients that die within 30 days of the revascularization procedure.|30 days||||Participants|||Count of Participants
2592208|NCT02260622|Secondary|TVR|Target vessel revascularization (TVR between day 1 and final visit)|1 year||||Participants|||Count of Participants
2592209|NCT02260622|Secondary|The Number of Patients Requiring Target Lesions Revascularization Between Day 1 and the Final Visit (TLR)|Target lesion revascularization (TLR) between day 1 and final visit|1 year||||Participants|||Count of Participants
2592210|NCT02260622|Secondary|Overall Survival|Overall survival. How long a patient is alive following the intervention.|1 year||||Participants|||Count of Participants
2592211|NCT02260622|Secondary|Event-free Survival|Event-free survival How long a patient is alive without the need for any further intervention or vascular events.|1 year||||Participants|||Count of Participants
2592212|NCT02260622|Secondary|Number of Participants With 2 Class Improvement on the Rutherford Scale|"Clinical improvement defined as cumulative improvement of 2 classes of the Rutherford scale without the need for repeated TLR in surviving patients.~There are seven stages to consider. the lower the score the less severe the disease or condition.~Rutherford Scale:~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene"|1 year||||Participants|||Count of Participants
2592213|NCT02260622|Primary|Reintervention, Above Ankle Amputation and Restenosis (RAS)|The primary outcome is a combined endpoint consisting of any Reintervention (surgical procedures to revascularize), Above ankle amputation and restenosis(recurrence of blockage in the vein) (RAS) at one year|1 year||||Participants|||Count of Participants
2592214|NCT02260492|Secondary|Number of Participants With Adverse Events||From Screen (Day -28) until 1 week post last treatment|One subject who was assigned OT329 SOLIS received placebo treatment kit in error. The mistake was discovered on Day 1 and the patient was removed from the study. The patient was included in the OT329 SOLIS group for the intent-to-treat analysis but was put in the Placebo group for the Safety analysis as defined by the Statisical Analysis Plan.|||Participants|||Count of Participants
2592218|NCT02260440|Secondary|Progression-free Survival (PFS)|Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years|Participants who received at least one dose of study therapy (median, 3 cycles; range, 1-8).|||months||95% Confidence Interval|Median
2592219|NCT02260440|Primary|Objective Response Rate (ORR)|The objective response rate is estimated by the proportion (percentage) of participants with the best response of complete response (CR), or partial response (PR) by RECIST 1.1 criteria, with corresponding exact 95% confidence limits being reported. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 14 months|Participants who received at least one dose of study therapy (median, 3 cycles; range, 1-8).|||percentage of participants||95% Confidence Interval|Number
2592220|NCT02260401|Secondary|Healthcare Utilization|We will determine if providing individualized reports to the LESS trial participants at 198 months impacts healthcare utilization for spinal stenosis between 18 and 24 months (including doctors visits, physical therapy, surgery, opioid use)|24 months||2017-04-30|04/2017||||
2592221|NCT02260401|Primary|Utilization of ESI|We will measure whether or not providing these individualized reports to patients impacts patients decision-making regarding use of epidural steroid injections between 18 and 24 months|24 months||||number of ESI between 18-24 months||Standard Deviation|Mean
2592222|NCT02260388|Secondary|PROMIS Sleep Disturbance Short Form v1.0 8a|"Higher scores for sleep disturbance represents worse outcome (more sleep disturbance).~T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.~On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.~Higher scores equals more of the concept being measured"|12 weeks|No secondary data were collected for participants who 'Quit' taking the study medication prior to study completion. Thus, only participants that were deemed efficacious and non-quit, or non-efficacious and non-quit at the primary outcome were collected and analyzed for the secondary outcome measure.|||T-Score||Standard Deviation|Mean
2592223|NCT02260388|Secondary|PROMIS Fatigue Short Form v1.0 8a|"Higher scores for fatigue represents worse outcome (more fatigue). T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.~On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population."|12 Weeks|No secondary data were collected for participants who 'Quit' taking the study medication prior to study completion. Thus, only participants that were deemed efficacious and non-quit, or non-efficacious and non-quit at the primary outcome were collected and analyzed for the secondary outcome measure.|||T-Score||Standard Deviation|Mean
2592224|NCT02260388|Secondary|PROMIS Pain Interference Short Form v1.0 8a T Score|"Higher scores for pain interference represents worse outcome (more pain interference) T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.~On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population."|12 weeks|No secondary data were collected for participants who 'Quit' taking the study medication prior to study completion. Thus, only participants that were deemed efficacious and non-quit, or non-efficacious and non-quit at the primary outcome were collected and analyzed for the secondary outcome measure.|||T-Score||Standard Deviation|Mean
2592225|NCT02260388|Secondary|SF12 Health Composite Scores|"SF-12v2® Health Survey Standard The Optum™ SF-12v2® Health Survey is a shorter version of the SF-36v2® Health Survey that uses just 12 questions to measure functional health and well-being from the patient's point of view.~Survey provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.~Scores are calibrated so that 50 is the average score or norm, standard deviation = 10.~Higher scores indicate better health for both mental and physical component summary scores."|12 weeks|No secondary data were collected for participants who 'Quit' taking the study medication prior to study completion. Thus, only participants that were deemed efficacious and non-quit, or non-efficacious and non-quit at the primary outcome were collected and analyzed for the secondary outcome measure.|||Norm-Based Standardization Score||Standard Deviation|Mean
2592226|NCT02260388|Primary|Co-Primary Measures: Percent of Patients With at Least a 50% Decrease in Likert Pain Scale From Baseline to Week 12 Follow Up and Percent of Patients That Quit|The final outcome of the study is a combination of two endpoints, efficacy and quit or treatment discontinuation rates. The first endpoint was a patient responder-defined measure of efficacy. A patient was deemed efficacious if a 50% or more reduction was observed in the Likert pain-scale from the baseline visit to the 12 week visit (i.e. 6 at baseline to 3 or less at week 12). The second endpoint was the observed percentage of patients who discontinued treatment prior to the last follow up visit for any reason or were lost to follow up. The utility function, which combines efficacy and quit rates, was used to drive the adaptive randomization, stopping criteria, and final analysis conclusions.|12 weeks||||Participants|||Count of Participants
2592227|NCT02260180|Secondary|Mean Change of PLA From Baseline to Visit 8|Change from baseline PLA was calculated for each lesion first, then per-subject mean changes from baseline were calculated and served as the basis for the ANCOVA. The physician's Lesion Analysis is a 4 point scale from0 to 3, with 0 being lesion clear and 3 being the most severe lesion. For change from baseline a higher negative score is a better outcome.|Baseline to Visit 8|Study day01 / visit 2 has been considered as Baseline visit for calculating mean and mean change|||units on a scale||Standard Deviation|Mean
2592265|NCT02259348|Secondary|Rate of Transplant-related Mortality (TRM)|The cumulative incidence of transplant related mortality will be estimated using Kalbfleisch-Prentice method. Deaths before day 100 because of other reasons are the competing risk events.|100 days post transplantation|All six participants who received the protocol-defined treatment were evaluable for this analysis. One participant died of a non-transplant related cause (leukemia) prior to day 100. Although this participant did not complete the study to Day 100 post-transplantation, they were still evaluable for TRM.|||participants|||Number
2592228|NCT02260180|Primary|Mean of Per-subject Percentages of Target Lesions Judged to be Clear on the Physician's Lesion Assessment (PLA) Score (PLA = 0) at Visit 8.|The primary efficacy analysis was the mean of per-subject percentages of target lesions judged to be clear on the PLA (PLA = 0) at Visit 8. The PLA is a four point scale from 0 to 3 with 0 being a clear lesion and 3 being the worst lesion. A comparison between each active treatment group and the vehicle treatment group based on the proportion of subjects whose target lesion is judged to be clear on the PLA (PLA = 0) at Visit 8. A higher percentage is a better outcome.|Day 106|Participants completing the study.|||Participants|||Count of Participants
2592229|NCT02260154|Secondary|Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form 2|"Changes in Stool Habits: The change is presented as the proportion of patients whose Changes in Stool Habits from 'Abnormal' to 'Normal' and vice versa were registered. Positive is defined as Change from 'Abnormal stool form at BL' to 'Normal stool form at Week 6'. Negative is defined as Change from 'Normal stool form at BL' to 'Abnormal stool form at Week 6'."|Baseline to Week 6|Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day|||percentage of participants|||Number
2592230|NCT02260154|Secondary|Health Economics Data 3|Number of days missed from work for currently employed subjects. Change is calculated as Week 6 value minus Baseline value. Negative change means less number of days missed from work.|change from baseline at Week 6|Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200mg twice a day|||Number of days||Standard Deviation|Mean
2592231|NCT02260154|Secondary|Healths Economic Data 2|Number of visits to clinic for currently employed subjects. Change is calculated as Week 6 value minus Baseline value. Negative change means less number of visits to clinic.|from baseline at Week 6|Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day|||number of visits||Standard Deviation|Mean
2592232|NCT02260154|Secondary|Reasons for Continuing Treatment Beyond 2 Weeks|List and rate of reasons|2 weeks|Extended Set includes those patients who completed at least 6 weeks treatment of Duspatalin|||percentage of participants|||Number
2592233|NCT02260154|Secondary|Health Economic Data|Relevant concomitant medication|Baseline, up to 6 weeks|Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day|||percentage of participants|||Number
2592234|NCT02260154|Secondary|Changes in Quality of Life|Gastrointestinal Quality of Life Index contains 36 questions with 4 possible answers per each (most desirable option returns 4 points, and least desirable option returns 0 points). Total score of the GIQLI is calculated as sum of all items. The source scores are transformed and scaled from 0 to 100. The high score corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value.|Baseline, 2 weeks and up to 6 weeks|Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day|||units on a scale||Standard Deviation|Mean
2592235|NCT02260154|Secondary|Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form|"Changes in Stool Habits: The change is presented as the proportion of patients whose Changes in Stool Habits from 'Abnormal' to 'Normal' and vice versa were registered. Positive is defined as Change from 'Abnormal stool form at BL' to 'Normal stool form at Week 2'. Negative is defined as Change from 'Normal stool form at BL' to 'Abnormal stool form at Week 2'."|Baseline to Week 2|Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day|||percentage of participants|||Number
2592236|NCT02260154|Secondary|Changes in Dyspepsia Symptoms|Measured by 11-items Numerous Rating Scale where 0 represents no symptoms and 10 represents the worst symptoms. Negative change corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value.|Baseline, 2 weeks and up to 6 weeks|Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day|||units on a scale||Standard Deviation|Mean
2592237|NCT02260154|Secondary|Changes in Abdominal Pain|Measured by 11-items Numerous Rating Scale where 0 represents no pain and 10 represents the worst pain. Negative change corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value.|Baseline, 2 weeks and up to 6 weeks|Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day|||units on a scale||Standard Deviation|Mean
2592238|NCT02260154|Secondary|"Percentage of Responders to Duspatalin® Therapy"||Up to 6 weeks|Extended set includes those patients who completed at least 6 weeks treatment of Duspatalin|||percentage of participants||95% Confidence Interval|Number
2592239|NCT02260154|Primary|"Percentage of Responders to Duspatalin® Therapy"|Patients indicating being `symptom-free` or `markedly improved`on Global Patient Assessment|2 weeks|Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day|||percentage of participants||95% Confidence Interval|Number
2592240|NCT02259699|Other Pre-specified|Process Outcome - Satisfaction With PCOA Aid|Usability and acceptability of PCOA data will be gathered only from the intervention arm. The usability and acceptability of the PCOA program will be determined both through objective data gathered as patients use the application, and through subjective data gathered through a short, self-report survey that will appear on the PCOA application at the end of the session.|at treatment initiation||||Participants|||Count of Participants
2592241|NCT02259699|Secondary|Cancer Therapy Satisfaction|"While the EORTC IN-PATSAT32, assessed cancer patients' appraisal of doctors, nurses, and services, the Satisfaction with Cancer Treatment Questionnaire assessed patients' satisfaction specifically with their most recent therapy (i.e. IV or pills). The scale contained 21 items assessing seven domains. Total scores were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction with their most recent therapy.~This has been validated on adults with many cancer types and treatments."|at treatment completion (T3) and 9 months post enrollment (T4)|Includes 48 PCOA and 52 UC with complete data at T3|||tansformed scale score||Standard Error|Mean
2592374|NCT02258373|Secondary|Number of Participants With >=1 Diabetic Ketoacidosis (DKA) Events||Between baseline (randomization) and 6 months||||Participants|||Count of Participants
2592242|NCT02259699|Secondary|Satisfaction With Care (EORTC) Overall Quality Rating|Satisfaction with Care was measured using the EORTC IN-PATSAT32, which assessed cancer patients' appraisal of doctors and nurses, as well as aspects of care organization and services. The measure also discriminated between cancer patients with different care expectations. Scores from these 32 items were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction. This measure has excellent internal consistency and convergent validity, although some scales are highly correlated. Test-retest reliability is acceptable.|at treatment completion (T3) and 9 months post enrollment (T4)|Includes 48 PCOA and 52 UC with complete data at T3|||tansformed scale score||Standard Error|Mean
2592243|NCT02259699|Secondary|Shared Decision Making|"The 9-item Shared Decision Making Questionnaire (SDM-Q-9) was developed and psychometrically tested for use in clinical encounters. It has strong reliability and validity, and use is advocated in studies investigating the effectiveness of interventions aimed at implementing shared decision-making. The question stem indicated the medical decision (IP/IV) with 6 levels of agreement from 'completely disagree to completely agree' (e.g., My doctor and I selected a treatment option together). Total scores were linearly transformed to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM. SDM was assessed at T1 only, since this was the most proximal in time to when the decision was made."|at treatment initiation (T1)|Includes 63 PCOA and 56 UC with complete data|||tansformed scale score||Standard Error|Mean
2592244|NCT02259699|Primary|Decisional Regret|"The Decision Regret Scale is a 5-item scale which is a reliable and valid indicator of health care decision regret at a given point in time, with excellent psychometric properties. In this study, the question stem will ask about the decision you made about selecting IP/IV treatment. Total scores were linearly transformed to a 0-100 scale. The lowest possible score, 0, means no regret. The highest possible score, 100, means high regret. This outcome will be measured from T2 - T4, but is not appropriate to ask at the time of the T1 assessment, which is just after the treatment decision has been made, but prior to treatment delivery. Use of this measure will allow us to evaluate whether the PCOA, compared to usual care, helps to reduce regret during and after cancer treatment."|At treatment completion (T3) and 9 months post enrollment (T4)|Includes 48 PCOA and 52 UC with complete data at T3|||transformed scale score||Standard Error|Mean
2592245|NCT02259699|Primary|Satisfaction With Decision|Satisfaction with Decision scale (SWD) is a 6-item scale measuring satisfaction with health care decisions, developed and validated in the context of women making decisions about hormone replacement therapy, and subsequently validated in adults with depression making decisions about treatment. The scale has good internal consistency reliability (alpha = 0.85), evidence of construct validity, relevance to designing and assessing patient-centered decision support interventions, and is sensitive to changes in information in trials of decision aids. The scale uses a 1-5 rating (1=strongly disagree; 5 = strongly agree). Scores from these 6 items were linearly transformed to a 0-100 scale. A higher score reflects a higher level of satisfaction with the decision.|at treatment initiation (T1), treatment completion (T3), and 9 months post enrollment (T4)|Includes 63 PCOA and 56 UC with complete data|||transformed scale score||Standard Error|Mean
2592246|NCT02259608|Secondary|Cytokine Production Measured by ELISA Compared to Baseline|Ex-vivo cytokine production by PBMCs upon stimulation with several pathogens|0 weeks and 2 weeks||||ratio||Full Range|Mean
2592247|NCT02259608|Primary|Cytokine Production Measured by ELISA Compared to Baseline|"Comparing tnfa production of PBMCs after 24h stimulation with candida before and 3 months after yBCG vaccination.~Baseline is set as 1."|0 weeks and 3 months|Ex-vivo cytokine production by PBMCs upon stimulation with several pathogens|||ratio||Full Range|Mean
2592248|NCT02259582|Primary|To Compare the Investigator-assessed (RECIST) v1.1 Response Rate in the Treatment Arms.|Investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 response rate (unconfirmed) in placebo/placebo arm to demcizumab/placebo arm and demcizumab/demcizumab arm combined in subjects with first-line stage IV non-small cell lung cancer (NSCLC). Response rate was based on Investigator-assessed best-overall-response (BOR) and was defined as the best unconfirmed response determined by RECIST version 1.1 recorded from the start of the treatment until disease progression in the following order of importance: CR, PR , SD, progressive disease (PD), not evaluable, or missing.|Response assessment data was collected until the subject started alternative anti-cancer treatment or developed progressive disease, whichever occurred first, assessed up to approximately 26 months.||||Participants|||Count of Participants
2592249|NCT02259400|Secondary|Death||1 month||||participants|||Number
2592250|NCT02259400|Secondary|Late Onset Sepsis||after fifth days of life up 2 month of life||||participants|||Number
2592251|NCT02259400|Secondary|Early Onset Sepsis||5days from birth||||participants|||Number
2592252|NCT02259400|Secondary|Newborns Who Received Multiple Surfactant Doses||10 days||||participants|||Number
2592253|NCT02259400|Secondary|Necrotizing Enterocolitis (NEC)||1 month||||participants|||Number
2592254|NCT02259400|Secondary|Patent Ductus Arteriosus Requiring Pharmacological Treatment (PDA)||first week of life||||participants|||Number
2592255|NCT02259400|Secondary|Retinopathy of Prematurity (ROP)||3 month of life||||participants|||Number
2592256|NCT02259400|Secondary|Periventricular Leukomalacia (PVL)||3 month of life||||participants|||Number
2592257|NCT02259400|Secondary|Intraventricular Hemorrhage (IVH)||1 month of life||||participants|||Number
2592258|NCT02259400|Secondary|Pneumothorax (PNX)||10 days||||participants|||Number
2592259|NCT02259400|Secondary|Bronchopulmonary Dysplasia (BPD)||36 weeks of postconceptional age or time of discharge|2 newborns died in bipap group|||participants|||Number
2592260|NCT02259400|Secondary|Death||2 month||||participants|||Number
2592261|NCT02259400|Primary|Failure of NIV Support|NUMBER OF NEWBORNS WHO FAILED WITH NON INVASIVE VENTILATION SUPPORT AND NEEDED INTUBATION AND INVASIVE MECHANICAL VENTILATION.|10 days||||participants|||Number
2592262|NCT02259400|Primary|Duration of NIV Support|DURATION OF NON INVASIVE VENTILATION SUPPORT FOR RDS TREATMENT|10 days||||HOURS||Inter-Quartile Range|Median
2592263|NCT02259348|Post-Hoc|Median Days to Absolute Neutrophil Count (ANC) Engraftment|ANC engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm^3 with evidence of donor cell engraftment.|Day 42 post transplantation||||days||Full Range|Median
2592267|NCT02259348|Secondary|Incidence and Severity of Acute GvHD|The cumulative incidence of acute GvHD will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The severity of acute GvHD. The number of participants with incidence by grade is given. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe.|100 days post transplantation|Two of six participants did not experience any acute GvHD.|||participants|||Number
2592268|NCT02259348|Secondary|Overall Survival (OS)|The Kaplan-Meier estimate of OS along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\kme) available in the Department of Biostatistics at St. Jude, where OS = min (date of last follow-up, date of death) - date of transplant and all participants surviving at the time of analysis without events will be censored. The number of participants surviving to one-year post-transplantation is given.|one year post transplantation||||participants|||Number
2592269|NCT02259348|Secondary|Event-free Survival (EFS)|The Kaplan-Meier estimate of event-free survival (EFS) along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\kme) available in the Department of Biostatistics at St. Jude, where EFS = min (date of last follow-up, date of relapse, date of graft failure, date of death due to any cause) - date of transplant, and all participants surviving at the time of analysis without events will be censored. The number of participants who did not experience any of these events through one year post-transplant is given.|one year post transplantation||||participants|||Number
2592270|NCT02259348|Secondary|Incidence of Malignant Relapse|The estimate of cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Death is the competing risk event. The number of participants with incidence of malignant relapse is given. Relapse was evaluated using standard WHO criteria for each disease.|one year post transplantation||||participants|||Number
2592271|NCT02259348|Primary|Percentage of Participants Engrafted by Day 42 Post-transplant|To estimate engraftment by day +42 post-transplant in patients who receive CD45RA-depleted haploidentical donor progenitor cell transplantation following reduced intensity conditioning regimen that includes haploidentical NK cells. Engraftment is defined as the first of 3 consecutive tests performed on different days of an ANC ≥ 500/mm^3 with evidence of donor cell engraftment.|Day 42 post transplantation||||percentage of participants|||Number
2592272|NCT02259114|Secondary|Total Plasma Clearance (CL) of MK-8628|Blood samples were obtained at specified time points for PK analysis of the CL of MK-8628. The CL of MK-8628 after administration is presented.|Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdose|The PK Population consisted of all participants who received MK-8628 on Cycle 1 Day 1 and had blood samples drawn for PK analyses.|||Liters/Hour||Standard Deviation|Mean
2592273|NCT02259114|Secondary|Terminal Half-Life (t1/2) of MK-8628|Blood samples were obtained at specified time points for PK analysis of the t1/2 of MK-8628. The t1/2 of MK-8628 after administration is presented.|Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdose|The PK Population consisted of all participants who received MK-8628 on Cycle 1 Day 1 and had blood samples drawn for PK analyses.|||Hours||Standard Deviation|Mean
2592274|NCT02259114|Secondary|Volume of Distribution at Steady State (Vdss) of MK-8628|Blood samples were obtained at specified time points for PK analysis of the Vdss of MK-8628. The Vdss of MK-8628 after administration is presented.|Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdose|The PK Population consisted of all participants who received MK-8628 on Cycle 1 Day 1 and had blood samples drawn for PK analyses.|||Liters||Standard Deviation|Mean
2592275|NCT02259114|Secondary|Area Under to Concentration-Time Curve From 0 to Infinity (AUC0-∞) of MK-8628|Blood samples were obtained at specified time points for PK analysis of the AUC0-∞ of MK-8628. The AUC0-first is AUC0-∞ which is derived from the post-hoc estimate of CL/F from the population model. The AUC0-∞ of MK-8628 after administration is presented.|Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdose|The PK Population consisted of all participants who received MK-8628 on Cycle 1 Day 1 and had blood samples drawn for PK analyses.|||μg*h/L||Standard Deviation|Mean
2592276|NCT02259114|Secondary|Time to Cmax (Tmax) of MK-8628|Blood samples were obtained at specified time points for PK analysis of the Tmax of MK-8628. The Tmax of MK-8628 after administration is presented.|Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdose|The PK Population consisted of all participants who received MK-8628 on Cycle 1 Day 1 and had blood samples drawn for PK analyses.|||Hours||Standard Deviation|Median
2592277|NCT02259114|Secondary|Observed Maximum Plasma Concentration (Cmax) of MK-8628|Blood samples were obtained at specified time points for pharmacokinetic (PK) analysis of the observed Cmax of MK-8628. The observed Cmax of MK-8628 after administration is presented.|Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdose|The Pharmacokinetics (PK) Population consisted of all participants who received MK-8628 on Cycle 1 Day 1 and had blood samples drawn for PK analyses.|||μg/L||Standard Deviation|Mean
2592278|NCT02259114|Secondary|Best Overall Response as Assessed in Solid Tumors by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or in Castration-resistant Prostate Cancer (CRPC) by Prostate Cancer Clinical Trials Working Group (PCWG2) Response Criteria|The best overall response was the best response recorded from the start of the study treatment until the end of treatment. RECIST 1.1 response categories included: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Up to approximately 16.5 months|The Efficacy Population consisted of all participants who received ≥2 complete cycles (6 weeks) of study treatment and underwent baseline assessment and 1 on-study tumor assessment, or who discontinued early due to disease progression.|||Participants|||Count of Participants
2592279|NCT02259114|Secondary|Number of Participants Who Discontinued Study Treatment Due to an AE|The number of participants who discontinued study treatment due to an AE is presented.|Up to approximately 16.5 months|The Safety Population consisted of all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2592280|NCT02259114|Secondary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An AE is defined as any untoward medical occurrence associated with use of study treatment in humans, whether or not considered treatment related. The number of participants who experienced at least one AE is presented.|Up to approximately 17.5 months (Up to 30 days after last dose of study treatment)|The Safety Population consisted of all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2592281|NCT02259114|Primary|Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1|A DLT was defined as any of the following toxicities that were considered by the investigator to be related to MK-8628: Hematologic toxicity: Grade 4 hematologic toxicity or febrile neutropenia, Grade 3 neutropenia with infection, Grade 3 thrombocytopenia with bleeding or lasting >7 days; Non-hematologic toxicity: Grade 3 or 4 non-hematologic toxicity (regardless of duration) unless it was not optimally managed with supportive care, Grade 3 or 4 laboratory abnormality, with or without symptoms, lasting >48 hours, Intolerable Grade 2 non-hematologic toxicity resulting in study drug discontinuation or delay >7 days with or without dose reduction, Designated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) liver test abnormalities; Treatment delay >2 weeks or dose reduction requirement for initiating Cycle 2.|Up to Cycle 1 Day 21 (Up to 21 days)|The DLT Evaluable Population consisted of all participants who received ≥85% of the planned dose of study treatment (18 days for Continuous Dosing Regimens, or 6 days for Days 1-7 Dosing Regimens) or experienced a DLT during the first 21-day cycle.|||Participants|||Count of Participants
2592282|NCT02259088|Secondary|Mean Number of Ranibizumab Re-treatments Received in the Study Eye From Month 3 Onward|A ranibizumab re-treatment was defined as an administration of ranibizumab injection at a scheduled visit following at least one non-missed visit where ranibizumab was not administered in the study eye due to visual acuity stabilization. This outcome measure was pre-specified for the Ranibizumab 0.5 mg arm only.|Monthly from Month 3 through Month 12|Safety Analysis Set|||retreatments||Standard Deviation|Mean
2592283|NCT02259088|Secondary|Mean Change From Baseline in Patient-Reported Driving at Month 6 and Month 12|Driving was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in driving, while a negative change value indicates a worsening. Note: Many patients did not answer the driving related question as they did not drive at all.|Baseline, Month 6, Month 12|Full Analysis Set, observed data (no missing data imputations).The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.|||units on a scale||Standard Deviation|Mean
2592284|NCT02259088|Secondary|Mean Change From Baseline in Patient-Reported Dependency at Month 6 and Month 12|Dependency was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in dependency, while a negative change value indicates a worsening.|Baseline, Month 6, Month 12|Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.|||units on a scale||Standard Deviation|Mean
2592285|NCT02259088|Secondary|Mean Change From Baseline in Patient-Reported Roles Difficulties at Month 6 and Month 12|Roles difficulties were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in roles difficulties, while a negative change value indicates a worsening.|Baseline, Month 6, Month 12|Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.|||units on a scale||Standard Deviation|Mean
2592286|NCT02259088|Secondary|Mean Change From Baseline in Patient-Reported Mental Health at Month 6 and Month 12|Mental health was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in mental health, while a negative change value indicates a worsening.|Baseline, Month 6, Month 12|Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.|||units on a scale||Standard Deviation|Mean
2592287|NCT02259088|Secondary|Mean Change From Baseline in Patient-Reported Social Functioning at Month 6 and Month 12|Social functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in social functioning, while a negative change value indicates a worsening.|Baseline, Month 6, Month 12|Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.|||units on a scale||Standard Deviation|Mean
2592288|NCT02259088|Secondary|Mean Change From Baseline in Patient-Reported Distance Activities at Month 6 and Month 12|Distance activities were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in distance activities, while a negative change value indicates a worsening.|Baseline, Month 6, Month 12|Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.|||units on a scale||Standard Deviation|Mean
2592289|NCT02259088|Secondary|Mean Change From Baseline in Patient-Reported Near Activities at Month 6 and Month 12|Near activities were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in near activities, while a negative change value indicates a worsening.|Baseline, Month 6, Month 12|Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.|||units on a scale||Standard Deviation|Mean
2592290|NCT02259088|Secondary|Mean Change From Baseline in Patient-Reported Ocular Pain at Month 6 and Month 12|Ocular pain was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in ocular pain, while a negative change value indicates a worsening.|Baseline, Month 6, Month 12|Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.|||units on a scale||Standard Deviation|Mean
2592375|NCT02258373|Secondary|Number of Participants With >=1 Severe Hypoglycemia Events||Between baseline (randomization) and 6 months||||Participants|||Count of Participants
2592291|NCT02259088|Secondary|Mean Change From Baseline in Patient-Reported Peripheral Vision at Month 6 and Month 12|Peripheral vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in peripheral vision, while a negative change value indicates a worsening.|Baseline, Month 6, Month 12|Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.|||units on a scale||Standard Deviation|Mean
2592292|NCT02259088|Secondary|Mean Change From Baseline in Patient-Reported Color Vision at Month 6 and Month 12|Color vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in color vision, while a negative change value indicates a worsening.|Baseline, Month 6, Month 12|Full Analysis Set, observed data (no missing data imputations).The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.|||units on a scale||Standard Deviation|Mean
2592293|NCT02259088|Secondary|Mean Change From Baseline in Patient-Reported General Vision at Month 6 and Month 12|General vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in general vision, while a negative change value indicates a worsening.|Baseline, Month 6, Month 12|Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.|||units on a scale||Standard Deviation|Mean
2592294|NCT02259088|Secondary|Mean Change From Baseline in Patient-Reported General Health at Month 6 and Month 12|General health was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in general health, while a negative change value indicates a worsening.|Baseline, Month 6, Month 12|Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.|||units on a scale||Standard Deviation|Mean
2592295|NCT02259088|Secondary|Mean Change From Baseline in Patient-Reported Visual Functioning at Month 6 and Month 12, Composite Score|Visual functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in visual functioning, while a negative change value indicates a worsening.|Baseline, Month 6, Month 12|Full Analysis Set, observed data (no missing data imputations). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.|||units on a scale||Standard Deviation|Mean
2592296|NCT02259088|Secondary|Mean Average Change in BCVA From Month 4 to Month 12 Compared to Month 3|Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Nine monthly BCVA values were averaged [(Month4+Month5+...+Month12)/9],and the Month 3 BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.|Monthly from Month 3 through Month 12|Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF).|||letters||Standard Deviation|Mean
2592297|NCT02259088|Secondary|Percentage of Patients With BCVA ≥ 73 Letters at Month 12|Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. BCVA ≥ 73 letters is approximately equivalent to 20/40 on a Snellen chart. One eye (study eye) contributed to the analysis.|Month 12|Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF).|||percentage of participants|||Number
2592298|NCT02259088|Secondary|Percentage of Patients With BCVA Loss of < 10 and < 15 Letters From Baseline to Month 12|Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.|Baseline, Month 12|Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF).|||percentage of participants|||Number
2592299|NCT02259088|Secondary|Percentage of Patients With BCVA Gain of ≥ 10 and ≥ 15 Letters From Baseline at Month 12|Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.|Baseline, Month 12|Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF).|||percentage of participants|||Number
2592300|NCT02259088|Secondary|Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit|CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Optical Coherence Tomography (OCT). A negative change value indicates an improvement in macular edema, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.|Baseline, Monthly from Month 1 through Month 12|Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.|||micrometers||Standard Deviation|Mean
2592376|NCT02258373|Secondary|Number of Participants With no Worsening of HbA1c by Greater Than 0.3% AND no Severe Hypoglycemia Event||Between baseline (randomization) and 6 months|Missing followup HbA1c data for 7 in the CGM Only group and 2 in the CGM+BGM group.|||Participants|||Count of Participants
2592301|NCT02259088|Secondary|Mean Change From Baseline in BCVA (Letters) at Each Visit|Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.|Baseline, Monthly from Month 1 through Month 12|Full Analysis Set (FAS) with missing values imputed by the last observation carried forward (LOCF). The number analyzed is the number of patients with a value for both baseline and the specific post-baseline visit.|||letters||Standard Deviation|Mean
2592302|NCT02259088|Primary|Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12|Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Twelve monthly BCVA values were averaged [(Month1+Month2+...+Month12)/12], and the baseline BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.|Baseline, Monthly from Month 1 through Month 12|Full Analysis Set (FAS). Missing values imputed by the mean value last observation carried forward (MV-LOCF).|||letters||Standard Deviation|Mean
2592303|NCT02259010|Secondary|Number of Participants With Clinically Significant Change in Vital Sign Reported as AEs|Vital signs will include body temperature (oral), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).|First dose of study drug to 30 days after the last dose of study drug (up to 12 months)|Safety Population is defined as all participants who received at least 1 dose of any study drug and were used for all safety analyses. Although there were 2 parts to the study, however, data for adverse events was not collected separately for each part.|||Participants|||Count of Participants
2592304|NCT02259010|Secondary|Number of Participants With Clinically Significant Change in Weight Reported as AEs|Change relative to baseline in participant's weight measured throughout study.|First dose of study drug to 30 days after the last dose of study drug (up to 12 months)|Safety Population is defined as all participants who received at least 1 dose of any study drug and were used for all safety analyses. Although there were 2 parts to the study, however, data for adverse events was not collected separately for each part.|||Participants|||Count of Participants
2592305|NCT02259010|Secondary|Number of Participants With Abnormal Laboratory Values Reported as AEs|Standard safety laboratory tests included Chemistry and Hematology. Abnormal laboratory values that led to discontinuation or delay in treatment, dose modification, therapeutic intervention, or were considered by the investigator to be a clinically significant change from baseline were reported as AEs.|First dose of study drug to 30 days after the last dose of study drug (up to 12 months)|Safety Population is defined as all participants who received at least 1 dose of any study drug and were used for all safety analyses. Although there were 2 parts to the study, however, data for adverse events was not collected separately for each part.|||Participants|||Count of Participants
2592306|NCT02259010|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug to 30 days after the last dose of study drug (up to 12 months)|Safety Population is defined as all participants who received at least 1 dose of any study drug and were used for all safety analyses. Although there were 2 parts to the study, however, data for adverse events was not collected separately for each part.|||Participants|||Count of Participants
2592307|NCT02259010|Secondary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alisertib Metabolites M1 and M2 in Presence and Absence of Itraconazole in Part A||Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib without itraconazole arm; Day 10 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib with itraconazole arm|PK-Evaluable Population included participants who completed the protocol-specified dosing at Part A and had sufficient PK assessment to reliably estimate PK parameters. Here, number of participants analyzed are the total number of participants who were evaluable to this outcome measure at specified endpoint.|||hr*nmol/L||Standard Deviation|Mean
2592308|NCT02259010|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib Metabolites M1 and M2 in Presence and Absence of Itraconazole in Part A||Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib without itraconazole arm; Day 10 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib with itraconazole arm|PK-Evaluable Population included participants who completed the protocol-specified dosing at Part A and had sufficient PK assessment to reliably estimate PK parameters. Here, number of participants analyzed are the total number of participants who were evaluable to this outcome measure at specified endpoint.|||hr||Full Range|Median
2592309|NCT02259010|Secondary|Cmax: Maximum Observed Plasma Concentration for Alisertib Metabolites M1 and M2 in Presence and Absence of Itraconazole in Part A||Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib without itraconazole arm; Day 10 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib with itraconazole arm|PK-Evaluable Population included participants who completed the protocol-specified dosing at Part A and had sufficient PK assessment to reliably estimate PK parameters. Here, number of participants analyzed are the total number of participants who were evaluable to this outcome measure at specified endpoint.|||nmol/L||Standard Deviation|Mean
2592377|NCT02258373|Secondary|Change in HbA1c||Between baseline (randomization) and 6 months|Missing followup HbA1c data for 7 in the CGM Only group and 2 in the CGM+BGM group.|||mmol/mol||Standard Deviation|Mean
2592310|NCT02259010|Secondary|Terminal Phase Elimination Half-Life of Alisertib in Presence and Absence of Itraconazole in Part A||Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib without itraconazole arm; Day 10 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib with itraconazole arm|PK-Evaluable Population included participants who completed the protocol-specified dosing at Part A and had sufficient PK assessment to reliably estimate PK parameters. Here, number of participants analyzed are the total number of participants who were evaluable to this outcome measure at specified endpoint.|||hr||Standard Deviation|Mean
2592311|NCT02259010|Secondary|Tmax: Time to Reach Maximum Plasma Concentration of Alisertib in Presence and Absence of Itraconazole in Part A||Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib without itraconazole arm; Day 10 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib with itraconazole arm|PK-Evaluable Population included participants who completed the protocol-specified dosing at Part A and had sufficient PK assessment to reliably estimate PK parameters.|||hr||Full Range|Median
2592312|NCT02259010|Secondary|CL/F: Oral Clearance of Alisertib in Presence and Absence of Itraconazole in Part A||Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib without itraconazole arm; Day 10 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib with itraconazole arm|PK-Evaluable Population included participants who completed the protocol-specified dosing at Part A and had sufficient PK assessment to reliably estimate PK parameters. Here, number of participants analyzed are the total number of participants who were evaluable to this outcome measure at specified endpoint.|||L/hr||Standard Deviation|Mean
2592313|NCT02259010|Primary|AUC∞: Area Under the Plasma Concentration Curve From Time 0 to Infinity of Alisertib in Presence and Absence of Itraconazole in Part A||Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib without itraconazole arm; Day 10 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib with itraconazole arm|PK-Evaluable Population included participants who completed the protocol-specified dosing at Part A and had sufficient PK assessment to reliably estimate PK parameters. Here number of participants analyzed are the participants who were evaluable for this outcome measure at specified time points.|||hr*nmol/L||Standard Deviation|Mean
2592314|NCT02259010|Primary|AUC(Last): Area Under the Plasma Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration of Alisertib in Presence and Absence of Itraconazole in Part A||Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib without itraconazole arm; Day 10 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib with itraconazole arm|PK-Evaluable Population included participants who completed the protocol-specified dosing at Part A and had sufficient PK assessment to reliably estimate PK parameters.|||hr*nmol/L||Standard Deviation|Mean
2592315|NCT02259010|Primary|Cmax: Maximum Observed Concentration of Alisertib in Presence and Absence of Itraconazole in Part A||Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib without itraconazole arm; Day 10 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib with itraconazole arm|Pharmacokinetic (PK) -Evaluable Population included participants who completed the protocol-specified dosing at Part A and had sufficient PK assessment to reliably estimate PK parameters.|||nmol/L||Standard Deviation|Mean
2592316|NCT02258542|Secondary|Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA)|Assessments for the presence of ADA and nAb throughout study|From week 0 to week 108 study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period|Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents).|||Participants|||Number
2592317|NCT02258542|Secondary|Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study|Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study|From week 0 to week 56 in study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period|Full analysis set, excluding MELTEMI patients.|||Participants|||Number
2592318|NCT02258542|Secondary|Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA)|Endpoint: Pharmacokinetic (PK) parameters|Baseline and Week 108|All adolescent patients (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents)who received benralizumab, from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least 1 quantifiable serum PK observation post the first dose were included in the PK analysis dataset.|||ng/mL||95% Confidence Interval|Geometric Mean
2592319|NCT02258542|Secondary|Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study|Endpoint: Pharmacokinetic (PK) parameters|Week 0 and Week 56|All patients who received benralizumab, from whom PK blood samples were assumed not to be affected by factors such as protocol violations, and who had at least 1 quantifiable serum PK observation post the first dose were included in the PK analysis dataset.|||ng/mL||95% Confidence Interval|Geometric Mean
2592320|NCT02258542|Secondary|Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA)|Hospitalizations, ED visits, urgent care visits and all other outpatient visits due to asthma|Baseline and Week 108|Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups.|||Participants|||Count of Participants
2592321|NCT02258542|Secondary|Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period|Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma|From week 0 to week 68 in study treatment period and through the follow up period (16 weeks from day of last dose)|Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA.|||Participants|||Count of Participants
2605755|NCT02107014|Primary|Change in IL-9 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2592322|NCT02258542|Secondary|Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)|The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. The WPAI+CIQ outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|Week 108|Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups.|||Percentage||Standard Deviation|Mean
2592323|NCT02258542|Secondary|Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI)|The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. The WPAI+CIQ outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|Week 68|Full analysis set, excluding MELTEMI patients. Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; all patients enrolled from ZONDA.|||percentage||Standard Deviation|Mean
2592324|NCT02258542|Secondary|Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA)|The WPAI (+CIQ) is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Classroom productivity loss is calculated with sum of hours missed for classes due to health problem and hours that affected due to health problem in classes, divided by sum of hours missed due to health problem and hours actually attended classes, presented by percentage.|Week 108|Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups.|||Percentage||Standard Deviation|Mean
2592325|NCT02258542|Secondary|Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ)|The WPAI (+CIQ) is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Classroom productivity loss is calculated with sum of hours missed for classes due to health problem and hours that affected due to health problem in classes, divided by sum of hours missed due to health problem and hours actually attended classes, presented by percentage.|Week 56|Full analysis set, adolescents, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA.|||Percentage||Standard Deviation|Mean
2592326|NCT02258542|Secondary|Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)|The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Work productivity loss is calculated with sum of hours missed at work due to health problem and hours that affected due to health problem at work, divided by sum of hours missed due to health problem and hours actually worked, presented by percentage.|Week 108|Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups.|||Percentage||Standard Deviation|Mean
2592327|NCT02258542|Secondary|Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI)|The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Work productivity loss is calculated with sum of hours missed at work due to health problem and hours that affected due to health problem at work, divided by sum of hours missed due to health problem and hours actually worked, presented by percentage.|Week 68|Full analysis set, adults, excluding MELTEMI patients. Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; all patients enrolled from ZONDA.|||percentage||Standard Deviation|Mean
2592328|NCT02258542|Secondary|Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA)|The questionnaire included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state; thus, an increase in VAS score indicated improvement.|Week 108|Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups.|||Score on a scale||Standard Deviation|Mean
2592329|NCT02258542|Secondary|Change From Baseline in EQ-5D-5L Visual Analog Scale|The questionnaire included a visual analog scale (VAS) score, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state; thus, an increase in VAS score indicated improvement.|Week 56|Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA.|||Score on a scale||Standard Deviation|Mean
2592378|NCT02258373|Secondary|Percentage of Days With at Least 20 Minutes of Sensor Glucose Values >300 mg/dl||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percentage of days||Inter-Quartile Range|Median
2592330|NCT02258542|Secondary|Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA).|Change from baseline to Week 108 in Blood eosinophils.|Week 108|Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups.|||cell/uL||Standard Deviation|Mean
2592331|NCT02258542|Secondary|Change of Blood Eosinophil Levels' Measurement in Overall Patients|Change from baseline to Week 56 in Blood eosinophils|Week 56|Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA; separate by predecessor treatment groups.|||cell/uL||Standard Deviation|Mean
2592332|NCT02258542|Secondary|Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA)|Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli). It contains 32 questions on a 7 point scale ranging from 7 (no impairment) to 1 (severe impairment); total score is an average of all questions. An increase in score indicates improvement.|Week 108|Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups.|||Score on a scale||Standard Deviation|Mean
2592333|NCT02258542|Secondary|Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12)|Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli). It contains 32 questions on a 7 point scale ranging from 7 (no impairment) to 1 (severe impairment); total score is an average of all questions. An increase in score indicates improvement.|Week 56|Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA.|||Score on a scale||Standard Deviation|Mean
2592334|NCT02258542|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA)|Asthma Control Questionnaire 6 (ACQ-6) contains 1 bronchodilator use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses.|Week 108|Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups.|||Score on a scale||Standard Deviation|Mean
2592335|NCT02258542|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients|Asthma Control Questionnaire 6 (ACQ-6) contains 1 bronchodilator use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses.|Week 56|Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups.|||Score on a scale||Standard Deviation|Mean
2592336|NCT02258542|Secondary|Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)|Change from baseline to Week 108 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).|Week 108|Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups.|||L||Standard Deviation|Mean
2592337|NCT02258542|Secondary|Change From Baseline in Post-bronchodilator FEV1 (L)|Change from baseline to Week 56 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).|Week 56|Full analysis set, excluding MELTEMI patients. Only summarize for patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; separated by predecessor treatment groups. Patients from Study ZONDA are not summarized.|||L||Standard Deviation|Mean
2592338|NCT02258542|Secondary|Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)|Change from baseline to Week 108 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).|Week 108|Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups.|||L||Standard Deviation|Mean
2592339|NCT02258542|Secondary|Change From Baseline in Pre-bronchodilator FEV1 (L)|Change from baseline to Week 56 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).|Week 56|Full analysis set, excluding MELTEMI patients. For patients enrolled from SIROCCO/CALIMA, summarized by baseline eosinophils count>=300/uL, and <300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups.|||L||Standard Deviation|Mean
2592340|NCT02258542|Secondary|Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA)|Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit|From week 0 to week 108 in study treatment period and through the follow up period (16 weeks from day of last dose)|Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; separated by predecessor treatment groups.|||Participants|||Count of Participants
2592341|NCT02258542|Secondary|Number of Overall Patients With Asthma Exacerbations During Study Period|Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit|From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose)|Full analysis set, excluding MELTEMI patients. Summarized by subsets of patients enrolled from SIROCCO/CALIMA with baseline eosinophils count >=300/uL or <300/uL; all patients enrolled from ZONDA; separated by predecessor treatment groups.|||Participants|||Count of Participants
2592342|NCT02258542|Primary|Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)|Change from baseline in hematologic lab parameter of Bilirubin.|Week 108|Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.|||umol/L||Standard Deviation|Mean
2592343|NCT02258542|Primary|Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients|Change from baseline in chemistry test Bilirubin.|Week 56|Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.|||umol/L||Standard Deviation|Mean
2592344|NCT02258542|Primary|Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)|Change from baseline in hematologic lab parameter of AST.|Week 108|Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.|||ukat/L||Standard Deviation|Mean
2592345|NCT02258542|Primary|Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients|Change from baseline in chemistry tests AST.|Week 56|Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.|||ukat/L||Standard Deviation|Mean
2592346|NCT02258542|Primary|Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)|Change from baseline in hematologic lab parameter of ALT.|Week 108|Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.|||ukat/L||Standard Deviation|Mean
2592347|NCT02258542|Primary|Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients|Change from baseline in chemistry tests ALT.|Week 56|Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.|||ukat/L||Standard Deviation|Mean
2592348|NCT02258542|Primary|Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)|Change from baseline in hematologic lab parameter of Eosinophils.|Week 108|Full analysis set, adolescents only(studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.|||10^9 cells/L||Standard Deviation|Mean
2592349|NCT02258542|Primary|Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients|Change from baseline in hematologic lab parameter of Eosinophils.|Week 56|Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.|||10^9 cells/L||Standard Deviation|Mean
2592350|NCT02258542|Primary|Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)|Change from baseline in hematologic lab parameter of Neutrophils.|Week 108|Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.|||10^9 cells/L||Standard Deviation|Mean
2592351|NCT02258542|Primary|Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients|Change from baseline in hematologic lab parameter of Neutrophils.|Week 56|Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.|||10^9 cells/L||Standard Deviation|Mean
2592352|NCT02258542|Primary|Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)|Change from baseline in hematologic lab parameter of Lymphocytes.|Week 108|Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.|||10^9 cells/L||Standard Deviation|Mean
2592353|NCT02258542|Primary|Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients|Change from baseline in hematologic lab parameter of Lymphocytes.|Week 56|Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.|||10^9 cells/L||Standard Deviation|Mean
2592354|NCT02258542|Primary|Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)|Change from baseline in hematologic lab parameter of Leukocytes.|Week 108|Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.|||10^9 cells/L||Standard Deviation|Mean
2592355|NCT02258542|Primary|Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients|Change from baseline in hematologic lab parameter of Leukocytes.|Week 56|Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.|||10^9 cells/L||Standard Deviation|Mean
2592356|NCT02258542|Primary|Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)|Change from baseline in hematologic lab parameter of Basophils.|Week 108|Full analysis set, adolescents only (studies SIROCCO/CALIMA only, study ZONDA does not enroll adolescents). For each lab tests, number of patients is the number of patients with available change from baseline value.|||10^9 cells/L||Standard Deviation|Mean
2592357|NCT02258542|Primary|Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients|Change from baseline in hematologic lab parameter of Basophils.|Week 56|Full analysis set, excluding MELTEMI patients. For each lab tests, number of patients is the number of patients with available change from baseline value.|||10^9 cells/L||Standard Deviation|Mean
2592358|NCT02258529|Secondary|Changes in Health-Related Quality of Life|Changes in health-related quality of life was to be reported by participants using the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) questionnaire.||Due to the early termination of the study, data were not available for all participants, and therefore this prespecified analysis was not conducted.||||||
2592359|NCT02258529|Secondary|Overall Survival|Overall survival was defined as the interval from enrollment to death from any cause.||Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.||||||
2592360|NCT02258529|Secondary|Progression-Free Survival|Progression-free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression or death from any cause.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
2592361|NCT02258529|Secondary|Duration of Response|Duration of response (DOR) was defined as the interval from the first documentation of complete response or partial response to the earlier of the first documentation of disease progression or death from any cause.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
2592362|NCT02258529|Secondary|Time to Response|Time to response was defined as the the interval from the start of idelalisib treatment to the first documentation of complete or partial response.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
2592363|NCT02258529|Secondary|Idelalisib Trough and Peak Plasma Concentrations||Predose and 1.5 hour postdose at Weeks 2, 4, and 12|Pharmacokinetic (PK) Analysis Set: all participants in the ITT Analysis Set who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest.|||ng/mL||Standard Deviation|Mean
2592364|NCT02258529|Secondary|Rate of Grade ≥ 3 Transaminase Elevations Based on Laboratory Findings|The rate of Grade ≥ 3 transaminase elevations was defined as the number of participants with any Grade 3 or 4 alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations.|Up to 24 weeks plus 30 days|ITT Analysis Set: all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2592365|NCT02258529|Secondary|Overall Safety Profile of Idelalisib as Measured by the Incidence of Adverse Events (AEs), Severe AEs (SAEs), AEs Leading to Idelalisib (IDL) Interruption, Idelalisib Dose Reduction, Premature Discontinuation of Idelalisib, or Death||Up to 24 weeks plus 30 days|Intent-to-Treat (ITT) Analysis Set: all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2592366|NCT02258529|Primary|Overall Response Rate|Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response during idelalisib treatment. ORR was to be assessed by an independent review committee (IRC).||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
2592367|NCT02258477|Secondary|Number of Days That a Problem Snack Food Was Consumed at Any Time of Day in a Week.|Study participant will record daily the time problem snack food was consumed. Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at any time of day. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at any time of day/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose.|4 weeks|33 subjects completed the 4 week study.|||percentage of days in a week||Standard Deviation|Mean
2592368|NCT02258477|Secondary|Number of Days That a Problem Snack Food Was Consumed at the Identified Time of Waning Dietary Self-control.|"Study participant will record if the problem snack was consumed each day within the 3 hour period following consumption of the study beverage.~Note that the values in the data table below reflect the percentage of days within a week that subjects within each treatment dose consumed a problem snack food at the identified time of waning dietary self-control. The data does not represent change from baseline, but rather percentage of days within a week (calculated by how many days within a week subject consumed the problem snack food at the identified time of waning dietary self-control/ 7 days in a week) and can be compared week by week to see if there is any significant difference weekly when consuming a different dose of glucose."|4 weeks|33 subjects completed the 4 week study.|||percentage of days in a week||Standard Deviation|Mean
2592369|NCT02258477|Primary|Responses to the Control of Eating Questionnaire|"Study participant will complete Eating Questionnaire at baseline and the next 4 visits. Each questionnaire item used a likert scale (with ratings from 1 - 10). All question pertain to the last 7 days. Questionnaire items #9 asked what one food makes it most difficult for you to control eating? and question #10 asked  What time are you particularly vulnerable to this one food. Higher ratings are consistent with a more significant or more frequent outcome.~Note that values in the data table below are absolute scores at each week that the subject consumed the noted treatment dose. As subjects were randomized to different sequence orders to receive the study beverages, subjects consumed any given treatment dose at different weeks (depending on their randomized sequence order)."|4 weeks|33 participants completed the 4 week study and were randomized to one of four treatment sequences. Thus, each subject received each treatment for one week.|||units on a scale||Standard Deviation|Mean
2592370|NCT02258412|Primary|Bacterial Colony Forming Units Present on Hand Prints After Time Spent in Common Areas|Hand print plates will be collected from HCWs immediately after use of hand hygiene product and after time spent in common areas. Each HCW will use both products at least 3 days apart. Hand print plates from each product for each HCW will be compared.|On each of 2 days, Hand print plates collected from one hand immediately after product use (T0) and from other hand after time spent in MICU common areas||||log(10) transformed CFU||95% Confidence Interval|Mean
2592371|NCT02258373|Secondary|Number of Participants With >=1 Serious Adverse Event Other Than SH|"A serious adverse event is any untoward occurrence that:~Results in death.~Is life-threatening; (a non-life-threatening event which, had it been more severe, might have become life-threatening, is not necessarily considered a serious adverse event).~Requires inpatient hospitalization or prolongation of existing hospitalization.~Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions (sight threatening).~Is a congenital anomaly or birth defect.~Is considered a significant medical event by the investigator based on medical judgment."|Between baseline (randomization) and 6 months||||Participants|||Count of Participants
2592372|NCT02258373|Secondary|Number of Participants With >=1 Ketotic Events Not Meeting Criteria for DKA With Blood Ketone Level >=1.0 mmol/L||Between baseline (randomization) and 6 months||||Participants|||Count of Participants
2592373|NCT02258373|Secondary|Number of Participants With >=1 Ketotic Events Not Meeting Criteria for DKA With Blood Ketone Level >=0.6 mmol/L||Between baseline (randomization) and 6 months||||Participants|||Count of Participants
2592379|NCT02258373|Secondary|Percentage of Time With Sensor Values > 300 mg/dl, Measured With CGM||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percentage of time||Inter-Quartile Range|Median
2592380|NCT02258373|Secondary|Percentage of Time With Sensor Values > 250 mg/dl, Measured With CGM||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percentage of time||Inter-Quartile Range|Median
2592381|NCT02258373|Secondary|Percentage of Time With Sensor Values >180 mg/dl, Measured With CGM||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percentage of time||Inter-Quartile Range|Median
2592382|NCT02258373|Secondary|Percentage of Days With at Least 20 Minutes of Sensor Glucose Values <60 mg/dl||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percentage of days||Inter-Quartile Range|Median
2592383|NCT02258373|Secondary|Percentage of Time With Sensor Values <50 mg/dl, Measured With CGM||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percentage of time||Inter-Quartile Range|Median
2592384|NCT02258373|Secondary|Percentage of Time With Sensor Values <60 mg/dl, Measured With CGM||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percentage of time||Inter-Quartile Range|Median
2592385|NCT02258373|Secondary|Percentage of Time With Sensor Value <70 mg/dl, Measured With CGM||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percentage of time||Inter-Quartile Range|Median
2592386|NCT02258373|Secondary|Measures of Glycemic Variability: Coefficient of Variation|Coefficient of variation = SD/mean|Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percent||Inter-Quartile Range|Median
2592387|NCT02258373|Secondary|Mean Glucose||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||mg/dl||Standard Deviation|Mean
2592388|NCT02258373|Primary|Percentage of Time in Range of 70 to 180 mg/dl, Measured With CGM||Between baseline (randomization) and 6 months|One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.|||percentage of time||Standard Deviation|Mean
2592389|NCT02258334|Secondary|Geometric Mean Titer Ratios (GMTRs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Following Vaccination With the Respective Vaccine|Geometric mean titer ratios of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.|Day 21 post-vaccination|Geometric mean titer ratios were assessed in the Per-Protocol Analysis Set.|||Titer ratios||95% Confidence Interval|Geometric Mean
2592390|NCT02258334|Secondary|Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil) or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer 21 days after vaccination.|Day 21 post-vaccination|Seroconversion was assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
2592391|NCT02258334|Secondary|Percentage of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine.|Antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥40 (l/dilution [dil]) at pre-vaccination and 21 days after vaccination.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroprotection was assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
2592392|NCT02258334|Secondary|Geometric Mean Titers (GMTs) of Antibodies to the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine Antigens Before and Following Vaccination With the Respective Vaccine.|Geometric mean titers of antibodies to Fluzone® Quadrivalent, Fluzone® Intradermal, and Fluzone® High-Dose vaccine antigens were assessed using the hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titers were assessed in the Per-Protocol Analysis Set.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2592393|NCT02258334|Primary|Percentage of Participants Reporting Solicited Injection-site and Solicited Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 Injection-site reactions: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm. Grade 3 Systemic reactions: Fever, ≥39.0°C or ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.|||Percentage of participants|||Number
2592394|NCT02258256|Primary|Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard.|Mean systolic and diastolic pressures measured by the Sphygmo device blood pressure measurement and the commercially available device. Measurements were taken multiple times over the course of 24-72 hours at intervals determined by the supervising clinician. Mean blood pressure for each participant was measured using each device and compared between the two devices (Sphygmo minus Standard). The reported values represent the mean systolic and diastolic blood pressures measured by Sphygmo vs Gold Standard device, averaged across all participants|Measured during a single study visit, up to 24-72 hours.||||mmHg||Standard Deviation|Mean
2592395|NCT02258152|Secondary|To Assess the Effects of SYN120 on Cognitive Drug Research Computerized Cognition Battery (CDR) Quality of Episodic Memory (QEM)|"To access the effects of SYN120 for Quality of Episodic Memory. QEM measures the ability to store, hold, and retrieve information of an episodic nature. The stimuli are presented on a computer screen and the subjects respond by pressing either a Yes or No on a response box. It is a time measured test.~Quality of Episodic Memory is calculated as (DRECOACC + DRECNACC - 100) + (DPICOACC + DPICNACC - 100) +((IRCL - IRCLERR)*100 / 15) + ((DRCL - DRCLERR)*100 / 15), where DRECOACC is Word Recognition original stimuli accuracy (1 - 120 seconds), DRECNACC is word recognition new stimuli accuracy, DPICOACC is Picture Recognition original stimuli accuracy (1 - 120.5 seconds), DPICNACC is picture recognition new stimuli accuracy, IRCL is Immediate Word Recall (1 - 120.5 seconds), IRCLERR is immediate word recall errors, DRCL is Delayed Word Recall (1 - 120.5 seconds), and DRCLERR is delayed word recall errors. Higher QEM scores greater ability to retain memory."|up to Week 16|Protocol Deviation: No patient was discontinued from the study due to a protocol deviation and results based on the PP (per-protocol analysis set) population are similar to those from the mITT (modified intention-to-treat analysis set) population. Patients were not withdrawn from the study despite meeting withdrawal criteria.|||Seconds||Standard Deviation|Mean
2592396|NCT02258152|Primary|The Primary Efficacy Objective of This Study is to Assess the Efficacy of SYN120 on Cognition as Determined by the Cognitive Drug Research Computerized Cognition Battery (CDR) Continuity of Attention in Patients With Parkinson's Disease.|"To access the effect of SYN-120 for Continuity of Attention, a measure which reflects the ability to sustain attention and avoid error The Cognitive Drug Research Computerized Cognition Battery is a computerized neuropsychological test battery to assess cognitive tasks based on measures of Vigilance (1 - 180 seconds) and Choice Reaction Time (1 - 120 seconds). The stimuli are presented on a computer screen and the subjects respond by pressing either a Yes or No on a response box. It is a time measured test.~The ability to keep mind on a single task over time. COA is calculated as (VIGACC*0.45) + (CRTACC*0.5) - where VIGACC is digit vigilance accuracy, CRTACC is choice reaction time accuracy. Higher COA scores represent greater sustained attention and avoidance of errors."|up to Week 16|Protocol Deviation: No patient was discontinued from the study due to a protocol deviation and results based on the PP (per-protocol analysis set) population are similar to those from the mITT (modified intention-to-treat analysis set) population. Patients were not withdrawn from the study despite meeting withdrawal criteria.|||Seconds||Standard Deviation|Mean
2592397|NCT02257970|Secondary|Part 3: Change in Systemic Inflammatory Mediator Granulocyte Colony Stimulating Factor (G-CSF)|The systemic inflammatory response of G-CSF, in the two treatment groups, Ketoprofen and Placebo, will be assessed with Luminex-bead inflammasome analysis of pre- and post-treatment plasma samples. G-CSF, a glycoprotein, is an inflammatory cytokine produced by endothelium and immune cells. Ketoprofen is a unique NSAID possessing dual pathways of inflammatory inhibition, blocking cyclooxygenase (COX) and 5-LO. Measurement using median fluorescence intensity (MFI) was employed.|Baseline; 4 months|Data for this outcome was collected for Part 3 participants only.|||MFI (log10)||Standard Deviation|Mean
2592398|NCT02257970|Secondary|Part 2/Part 3: Change in Limb Volume|Quantitative assessment of limb volume (ml) of the affected limb at study end compared to pre-treatment values.|Baseline; 4 months|Data for this outcome were collected only for lymphedema-affected limbs only.|||ml||Standard Deviation|Mean
2592399|NCT02257970|Secondary|Part 2/Part 3: Change From Baseline in Bioimpedance Spectroscopy|A four-electrode configuration was used to non-invasively assess the extracellular and intracellular fluid contents of the limb. Data were analyzed according to Cole theory, using the manufacturer's software (Impedimed Ltd.), to provide values for a bioimpedance ratio (Ro), the resistance of the extracellular fluid including lymph, R∞ the resistance of total tissue fluid and Ri, the resistance of the intracellular fluid. For the purposes of these investigations, in patients with unilateral lymphedema, the ratio of Ro in the affected:unaffected limbs was analyzed in each patient, as a measure of the bioimpedance attributable to the extracellular fluid content. An Ro level of 1.034 was considered normal; values ≥1.034 were considered abnormal.|Baseline; 4 months|Data for this outcome were collected for Part 2 and Part 3 participants with unilateral lymphedema-affected limbs only.|||ratio of Ro values|limbs|Standard Deviation|Mean
2592400|NCT02257970|Secondary|Part 3: Change From Baseline in Cutaneous Histological Architecture|Quantitative assessment of paired histological specimens of lymphedema skin pre- and post-treatment with ketoprofen or placebo, respectively. The impact of treatment on cutaneous histopathology was evaluated through the use of an empirically-derived scoring system (comprised of dermal thickness, intercellular mucin content, deep dermal collagen content, and perivascular infiltrate); this quantitative assessment was developed and performed by a dermatopathologist. Each characteristic was weighted equally and each specimen was assigned a cumulative subscale score of 0-5. The scores were summed for a total score (range: 0-20) which is presented here. Higher scores indicate a higher degree of pathology. For the analysis, the 4-month post-minus-pre change in this score for ketoprofen- and placebo-recipients, respectively, was compared. A quantitatively higher negative change indicates a more favorable therapeutic response in the histology.|Baseline; 4 months|Data for this outcome were collected in Part 3 participants only and for lymphedema tissue samples only.|||score on a scale||Standard Deviation|Mean
2592401|NCT02257970|Secondary|Part 2: Measurement of Skin Thickness|Caliper measured skin thickness (mm) of lymphedema-affected limb was serially assessed and pre-to-post paired analysis was performed.|Baseline and 4 months|Data for this outcome were collected in Part 2 participants only and for lymphedema-affected limbs only.|||mm||Standard Deviation|Mean
2592402|NCT02257970|Primary|Part 3: Measurement of Skin Thickness|Caliper-measured skin thickness (mm) was serially assessed and pre-to-post paired analysis was performed for both arms (Placebo and Ketoprofen) of the study.|Baseline and 4 months|Data for this outcome were collected in Part 3 participants only and for lymphedema-affected limbs only.|||mm||Standard Deviation|Mean
2592419|NCT02257918|Primary|Number of Participants With Microbiological Cure at Urethral or Cervical Sites in Each Study Arm|Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. Male participants were swabbed at the urethral site and female participants at the cervical site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.|Day 6|The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at the urethral/cervical site at baseline.|||Participants|||Count of Participants
2592403|NCT02257970|Primary|Part 2: Change From Baseline in Cutaneous Histological Architecture|Quantitative assessment of paired histological specimens of lymphedema skin pre- and post-treatment with ketoprofen. The impact of treatment on cutaneous histopathology was evaluated through the use of an empirically-derived scoring system (comprised of dermal thickness, intercellular mucin content, deep dermal collagen content, and perivascular infiltrate); this quantitative assessment was developed and performed by a dermatopathologist. Each characteristic was weighted equally and each specimen was assigned a cumulative subscale score of 0-5. The scores were summed for a total score (range: 0-20) which is presented here. Higher scores indicate a higher degree of pathology. A quantitatively higher negative change indicates a more favorable therapeutic response in the histology.|Baseline; Month 4|This primary endpoint outcome was assessed in Part 2 participants only.|||score on a scale||Standard Deviation|Mean
2592404|NCT02257970|Primary|Part 1: Count of Participants Able to Complete Ketoprofen Treatment|Participants who were able to complete ketoprofen treatment and experienced no treatment-related serious adverse events.|Baseline to month 6|This outcome was assessed in Part 1 participants only.|||Participants|||Count of Participants
2592405|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Day 6|For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 6|The analysis population includes all participants who had isolates collected and results reported at the timepoint.|||µg/mL||Full Range|Median
2592406|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Baseline|For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 1 (Baseline)|The analysis population includes all participants who had isolates collected and results reported at the timepoint.|||µg/mL||Full Range|Median
2592407|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Day 6|For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 6|The analysis population includes all participants who had isolates collected and results reported at the timepoint, of which there were none for this anatomical site and timepoint.||||||
2592408|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Baseline|For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 1 (Baseline)|The analysis population includes all participants who had isolates collected and results reported at the timepoint.|||µg/mL||Full Range|Median
2592409|NCT02257918|Secondary|Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Day 6|For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 6|The analysis population includes all participants who had isolates collected and results reported at the timepoint.|||µg/mL||Full Range|Median
2592410|NCT02257918|Secondary|Median in Vitro Minimum Inhibitory Concentrations (MIC) Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Baseline|For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the minimum inhibitory concentration (MIC) was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.|Day 1 (Baseline)|The analysis population includes all participants who had isolates collected and results reported at the timepoint.|||µg/mL||Full Range|Median
2592411|NCT02257918|Secondary|Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Pharyngeal Specimens in Each Study Arm|Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the pharyngeal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.|Baseline and Day 6|The analysis population was restricted to participants who had a positive pharyngeal culture result for N. gonorrhoeae at baseline.|||Participants|||Count of Participants
2592412|NCT02257918|Secondary|Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Rectal Specimens in Each Study Arm|Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the rectal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.|Baseline and Day 6|The analysis population was restricted to participants who had a positive rectal culture result for N. gonorrhoeae at baseline.|||Participants|||Count of Participants
2592413|NCT02257918|Secondary|Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Day 6.|Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at Day 6 with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.|Day 6|The analysis population was restricted to participants who had a positive cervical/urethral culture result for N. gonorrhoeae at baseline.|||Participants|||Count of Participants
2592414|NCT02257918|Secondary|Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Baseline.|Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.|Day 1 (Baseline)|The analysis population was restricted to participants who had a positive cervical/urethral culture result for N. gonorrhoeae at baseline.|||Participants|||Count of Participants
2592415|NCT02257918|Secondary|Number of Participants With Clinical Cure in Each Study Arm|A clinical cure was defined as the resolution of all signs and symptoms of gonorrhea (e.g. cervical/vaginal/urethral discharge, dysuria, dyspareunia, vulvovaginal irritation, sore throat) that were present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. A clinical failure was defined by the presence of any sign or symptom of gonorrhea that was also present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. The investigator also submitted his/her determination of whether the participant met or did not meet the criteria for clinical cure (or whether it is unknown if the participant met the criteria). In the event the investigator's assessment of clinical cure did not coincide with the definitions of clinical cure/failure, the investigator's assessment was the final adjudicator.|Day 6|The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at any anatomical site and reported signs or symptoms of gonorrhea at baseline.|||Participants|||Count of Participants
2592416|NCT02257918|Secondary|Number of Participants With Microbiological Cure at Pharyngeal Sites in Each Study Arm|Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All subjects were swabbed at the pharyngeal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.|Day 6|The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at the pharyngeal site at baseline.|||Participants|||Count of Participants
2592417|NCT02257918|Secondary|Number of Participants With Microbiological Cure at Rectal Sites in Each Study Arm|Microbiological cure was assessed at the TOC visit. Microbiological cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All participants were swabbed at the rectal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A subject was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.|Day 6|The analysis population was limited to participants who had a positive culture result at the rectal site for N. gonorrhoeae at baseline.|||Participants|||Count of Participants
2592418|NCT02257918|Primary|Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Considered Product-related.|Adverse events are defined as any untoward medical occurrence regardless of its causal relationship to the study treatment. Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof was a congenital anomaly/birth defect; or may have jeopardized the subject or required intervention to prevent one of the outcomes. Relationship to study product was determined by the investigator and defined as a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event.|Day 1 through Day 31|All participants who received the study treatment were included in the analysis population. One participant enrolled in the Ceftriaxone arm was pregnant at enrollment and therefore, not treated.|||Participants|||Count of Participants
2592420|NCT02257684|Secondary|The Immunogenicity of IV Pegcristaspase by Testing Anti-pegcrisantaspase and Anti-PEG Binding and Neutralizing Antibodies||30 Days|Not Applicable, as the study was terminated before this endpoint was analyzed.||||||
2592421|NCT02257684|Secondary|The SAA Levels Over Time Following Repeated Administration in Children and Young Adults ALL/LBL and Hypersensitivity to Pegaspargase||30 Days|Not Applicable, as the study was terminated before this endpoint was analyzed.||||||
2592422|NCT02257684|Secondary|The Pharmakokinetic (PK) Profile of IV Pegcrisantaspase in Children and Young Adults With ALL/LBL and Hypersensitivity to Pegaspargase. Pharmakokinetic Profiles to be Assessed Are: Half Life, Elimination Rate, Tmax, Cmax, AUC.||14 Days|Not Applicable, as the study was terminated before this endpoint was analyzed.||||||
2592423|NCT02257684|Primary|The Serum Asparaginase Activity 14 Days After the First Infusion of Study Drug and the Adverse Events in All Participants.||1 Year|Not Applicable, as the study was terminated before this endpoint was analyzed.||||||
2592424|NCT02257684|Primary|The Response Rate in Children & Young Adults With ALL/LBL and Hypersensitivity to Pegaspargase Defined as the Proportion of Subjects Having a Serum Asparaginase Activity (SAA) Level of >= 0.1 IU/mL Following the First IV Dose in Course 1||15 days during Course 1|Only 1 of the first 4 patients dosed achieved the predefined serum asparaginase activity (SAA) level above the 0.1 IU/mL therapeutic threshold 14 days following the first IV pegcrisantaspase dose in Course 1 (Primary Objective of the study).|||SAA Level IU/mL|||Number
2592425|NCT02257632|Secondary|Systemic VEGF-A Levels From Study Week 12 to 24 (Change From Baseline)|Adjustment of systemic VEGF-A levels of patients switching from aflibercept to ranibizumab to levels comparable to baseline or to levels comparable as in patients treated from baseline with ranibizumab|From study week 12 to 24|Per-Protocol Set (PPS) Number of participants analyzed at each time point represents patients with a value for both baseline and the specific post-baseline visit|||pg/ml||Standard Deviation|Mean
2592426|NCT02257632|Secondary|Systemic VEGF-A Protein Levels From Study Week 12 to 24|Systemic VEGF-A protein levels in patients switching from monthly 2 mg aflibercept injections to monthly 0.5 mg ranibizumab compared to patients treated with monthly 0.5 mg ranibizumab from baseline (standardized area under the curve)|From study week 12 to 24 (Days 85, 99, 113, 127, 141, 155, 169)|Per-Protocol Set (PPS)|||pg/mL||Standard Deviation|Mean
2592427|NCT02257632|Primary|Standardized Area Under the Curve (AUC) for VEGF A Levels by SIMOA (Quanterix's Single Molecule Array) Method for the Comparative Phase|The AUC was calculated using the trapezoidal rule, where all available measurement between Day 1 and Week 12 were used. The AUC was standardized by dividing the calculated value by the number of days from first to last measurement.|Baseline up to Week 12 visit (Days 1, 2, 8, 15, 29, 43, 57, 71, 85)|Per-Protocol Set (PPS)|||pg/mL||Standard Deviation|Mean
2592428|NCT02257541|Secondary|Phase Ib Study: Response Rate (RR)|"defined by RECIST 1.1 criteria and by CHOI criteria,and by EORTC criteria~PHASE 1b PARTICIPANTS ONLY~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"|32 weeks||||Participants|||Count of Participants
2592429|NCT02257541|Primary|Phase Ib Portion: Response Rate (RR)|"(CR+PR, RECIST 1.1) and by CHOI criteria~PHASE 1b PARTICIPANTS ONLY~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"|32 weeks||||Participants|||Count of Participants
2592430|NCT02257541|Primary|Phase Ib Study: Number of Participants With Dose-Limiting Toxicities|The phase Ib will be pursued in standard 3+3 format, based on toxicities encountered during the first cycle of therapy.|1 year||||Participants|||Count of Participants
2592431|NCT02257489|Secondary|ACE-083 Pharmacokinetics: Time of the Maximum Measured Plasma Concentration|Assessment of systemic absorption and exposure following local injection of ACE-083 into the thigh or lower leg muscle|PK samples were collected predose, and at 3 hours and 6 hours postdose.||||h (Tmax)|||Number
2592432|NCT02257489|Secondary|ACE-083 Pharmacodynamics|Pharmacodynamic assessments include measurements of thigh or lower leg volume and composition (by MRI) and muscle strength testing (by hand-held dynamometer and fixed system)|From initiation of treatment (Study Day 1) to end of follow up period (up to Study Day 106)|||||||
2592433|NCT02257489|Secondary|ACE-083 Pharmacokinetics: Maximum Measured Plasma Concentrations|Assessment of systemic absorption and exposure following local injection of ACE-083 into the thigh or lower leg muscle|PK samples were collected predose, and at 3 hours and 6 hours postdose.||||ng/mL (Cmax)|||Number
2592434|NCT02257489|Primary|ACE-083 Safety and Tolerability: Number of Subjects With Adverse Events|Safety/tolerability assessment, following intramuscular administration, includes adverse events, injection site reactions, laboratory measurements, vital signs, etc.|From initiation of treatment (Study Day 1) to end of follow up period (up to Study Day 106)||||Participants|||Count of Participants
2592435|NCT02257385|Secondary|Change From Baseline in Weighted Mean (WM) FEV1 Over 0-6 Hour Post-dose at Day 84|BL FEV1 was the mean of the 2 assessments made 30 and 5 min PD on Day 1. WM FEV1 derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1 and 84 using the 0-6 hr post-dose FEV1 measurements collected on that day, which included PD FEV1 (taken 30 and 5 min prior to dosing on Day 1 and the 30 and 5 min reading prior to dosing on Day 84) and post-dose FEV1 measurements at 1, 3 and 6 hr post-dose.WM change from BL was the WM at at the visit minus the BL value. Analysis was performed using a RM model with covariates of trt, BL FEV1 (mean of values measured at 30 and 5 min PD on Day 1) center group, day, day by BL and day by trt interaction, where day was nominal. Only par with data available at the specified TP were analyzed but all par w/o missing covariate information and with >=1 post-BL measurement were included in the analysis.|Baseline and Day 84|ITT Population|||Liters||Standard Error|Least Squares Mean
2592450|NCT02256917|Secondary|Clearance (CL) of Human-cl rhFVIII|CL of Human-cl rhFVIII measured using the one-stage (OS) assay|Before injection (within 1 h before injection) and up to 72 h (± 2 h) after the end of injection|The PK-PP population contained all patients in the PK analysis population who completed the initial PK sampling phase of the trial without significantly violating the inclusion/exclusion criteria or other aspects of the protocol considered to potentially affect the PK results.|||mL/hr/kg||Standard Deviation|Mean
2592451|NCT02256917|Secondary|Mean Residence Time (MRT) of Human-cl rhFVIII|MRT of Human-cl rhFVIII measured using the one-stage (OS) assay|Before injection (within 1 h before injection) and up to 72 h (± 2 h) after the end of injection|The PK-PP population contained all patients in the PK analysis population who completed the initial PK sampling phase of the trial without significantly violating the inclusion/exclusion criteria or other aspects of the protocol considered to potentially affect the PK results.|||hours||Standard Deviation|Mean
2592436|NCT02257385|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Treatment Day 85 (Visit 8)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in 1 second. BL was the mean of the 2 assessments made 30 and 5 minutes (min) pre-dose (PD) on Day 1. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained at 23 and 24 hours (hr) after dosing on Day 84 (at Week 12 + 1 day). Analysis was performed using mixed model repeated measures (RM) with covariates of trt, BL FEV1 (mean of values measured at 30 and 5 min PD on Day 1), center group, day, day by BL interaction and day by trt interaction, where day was nominal.|Baseline (BL) and Day 85|Per Protocol (PP) Pop: all ITT Pop par who were not full protocol deviators considered to impact efficacy. Only par with data available at the specified time points (TP) were analyzed but all par without (w/o) missing covariate information and with >= 1 post BL measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2592437|NCT02257372|Secondary|Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose on Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. The weighted mean was calculated by performing six-hour serial spirometry from the pre-dose FEV1 and post-dose FEV1 measurements at 15 minutes, 30 minutes, 1 hour, 3 hours and 6 hours. Baseline FEV1 is the mean of the two assessments made 30 and 5 min pre-dose on Treatment Day 1. Change from Baseline was calculated as weighted mean value on Day 84 minus the Baseline value. Analysis was performed using mixed model repeated measures with covariates of treatment, baseline FEV1 (mean of the values measured at 30 min and 5 min pre-dose on Day 1), type of ICS/LABA , smoking status, Day, Day by baseline interaction and Day by treatment interaction, where Day is nominal.|Baseline and Day 84|ITT population|||Liter||Standard Error|Least Squares Mean
2592438|NCT02257372|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 was measured using spirometry. BL FEV1 is the mean of the two assessments made 30 and 5 minutes (min) pre-dose on Day 1.Change from BL was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis was performed using mixed model repeated measures with covariates of treatment, BL FEV1 (mean of the values measured at 30 min and 5 min pre-dose on Day 1), type of ICS/LABA, smoking status, Day, Day by BL interaction and Day by treatment interaction, where Day is nominal.|Baseline (BL) and Day 85|Intent-to-treat (ITT) population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only participants with data available at specific timepoint were analyzed.|||Liter||Standard Error|Least Squares Mean
2592439|NCT02257099|Secondary|Tibial Tuberosity Trochlear Groove||Baseline||||mm||Standard Deviation|Mean
2592440|NCT02257099|Secondary|Tilt Angle||Baseline||||degrees||Standard Deviation|Mean
2592441|NCT02257099|Primary|Congruence Angle CBCT||Baseline||||degrees||Standard Deviation|Mean
2592442|NCT02256982|Primary|Number of Participants Post Operative/Radiation Therapy Complications|Out of the 3 participants enrolled, the patient in cohort 1 proceeded to surgery and 1 of the 2 patients in cohort 2 proceeded to RT. The other patient in cohort 2 developed disease progression and was removed from protocol.|90 Days||||participants|||Number
2592443|NCT02256969|Primary|Tear Break Up Time (TBUT)|TBUT measures the amount of time, in seconds, a dry spot appears in the tear film after each blink. Values less than 10 seconds are considered abnormal.|4 week Time Point||||Seconds||Standard Deviation|Mean
2592444|NCT02256969|Primary|Corneal Fluorescein Staining (CFS)|Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.|4 week Time Point||||units on a scale||Standard Deviation|Mean
2592445|NCT02256969|Primary|Symptom Assessment in Dry Eye (SANDE)|A two-item survey used to assess the frequency and severity of dry eye disease. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.|4 week Time Point||||units on a scale||Standard Deviation|Mean
2592446|NCT02256969|Primary|Ocular Surface Disease Index (OSDI)|A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.|4 week Time Point||||units on a scale||Standard Deviation|Mean
2592447|NCT02256917|Secondary|Number of Patients With Adverse Events (AEs)|AEs were documented at each (scheduled or unscheduled) study visit. Severity and seriousness of all AEs were documented by the investigator according to pre-defined criteria|At each study visit over the study duration (7-9 months)|The SAF population included 58 patients who received at least one infusion of Human-c1 rhFVIII in the GENA-21b trial|||Participants|||Count of Participants
2592448|NCT02256917|Secondary|Usage of Human-cl rhFVIII (FVIII IU/kg BW Per Week Per Patient)|Average weekly consumption of Human-cl rhFVIII reported as IU/kg BW per week per patient was determined during individualized prophylactic treatment|6 months|The analysis population comprised 56 patients who received at least one infusion of Human-cI rhFVIII for individualized prophylaxis in the GENA-21b trial.|||IU/kg per week||Standard Deviation|Mean
2592449|NCT02256917|Secondary|Volume of Distribution at Steady State (Vss) of Human-cl rhFVIII|Vss of Human-cl rhFVIII measured using the one-stage (OS) assay|Before injection (within 1 h before injection) and up to 72 h (± 2 h) after the end of injection|The PK-PP population contained all patients in the PK analysis population who completed the initial PK sampling phase of the trial without significantly violating the inclusion/exclusion criteria or other aspects of the protocol considered to potentially affect the PK results.|||mL/kg||Standard Deviation|Mean
2592452|NCT02256917|Secondary|Half Life (t1/2) of Human-cl rhFVIII|T1/2 of Human-cl rhFVIII measured using the one-stage (OS) assay|Before injection (within 1 h before injection) and up to 72 h (± 2 h) after the end of injection|The PK-PP population contained all patients in the PK analysis population who completed the initial PK sampling phase of the trial without significantly violating the inclusion/exclusion criteria or other aspects of the protocol considered to potentially affect the PK results.|||hours||Standard Deviation|Mean
2592453|NCT02256917|Secondary|In-vivo Recovery (IVR) of Human-cl rhFVIII|IVR of Human-cl rhFVIII measured using the one-stage (OS) assay and will be determined from the FVIII level before the infusion and the peak level after the infusion of Human-cl rhFVIII|Before injection (within 1 h before injection) and up to 72 h (± 2 h) after the end of injection|The PK-PP population contained all patients in the PK analysis population who completed the initial PK sampling phase of the trial without significantly violating the inclusion/exclusion criteria or other aspects of the protocol considered to potentially affect the PK results.|||% per IU/kg||Standard Deviation|Mean
2592454|NCT02256917|Secondary|AUC Divided by the Dose (AUCnorm) of Human-cl rhFVIII|AUCnorm of Human-cl rhFVIII measured using the one-stage (OS) assay|Before injection (within 1 h before injection) and up to 72 h (± 2 h) after the end of injection|The PK-PP population contained all patients in the PK analysis population who completed the initial PK sampling phase of the trial without significantly violating the inclusion/exclusion criteria or other aspects of the protocol considered to potentially affect the PK results.|||hr*IU/mL/(IU/kg)||Standard Deviation|Mean
2592455|NCT02256917|Secondary|Mean Prophylactic Dosing Interval|Mean over mean actual dosing intervals between two prophylactic treatments per patient. The mean time (hours) between two prophylactic doses of Human-cl rhFVIII in the prophylactic treatment Phase II per patient|6 months|The analysis population comprised 56 patients who received at least one infusion of Human-cI rhFVIII for individualized prophylaxis in the GENA-21b trial.|||hours||Standard Deviation|Mean
2592456|NCT02256917|Secondary|Median Prophylactic Dosing Interval|Median over median actual dosing intervals between two prophylactic treatments per patient. The median time (hours) between two prophylactic doses of Human-cl rhFVIII in the prophylactic treatment Phase II per patient|6 months|The analysis population comprised 56 patients who received at least one infusion of Human-cI rhFVIII for individualized prophylaxis in the GENA-21b trial.|||hours||Inter-Quartile Range|Median
2592457|NCT02256917|Secondary|Annualized Total Bleeding Rate in Patients With 2x/Week (or Less) Prophylaxis|Total annualized bleeding rate (ABR) in patients with 2x/week (or less) prophylaxis (GENA-21b) compared to historical bleeding rate in patients having received on-demand treatment (GENA-01) with Human-cl rhFVIII|6 months|The analysis population comprised 29 patients who received at least one infusion of Human-cI rhFVIII for individualized prophylaxis in the GENA-21b trial at intervals of 2x/week or less. Their annualized spontaneous bleeding rate was compared with those in patients from the completed GENA-01 trial who received only on-demand treatment.|||Bleeding events per year (ABR)||Standard Deviation|Mean
2592458|NCT02256917|Secondary|Annualized Spontaneous Bleeding Rate of Individually Tailored Prophylaxis|Spontaneous annualized bleeding rate (ABR) of individually tailored prophylaxis (GENA-21b) compared to historical bleeding rate in patients having received on-demand treatment (GENA-01) with Human-cl rhFVIII|6 months|The analysis population comprised 56 patients who received at least one infusion of Human-cI rhFVIII for individualized prophylaxis in the GENA-21b trial. Their annualized spontaneous bleeding rate was compared with those in patients from the completed GENA-01 trial who received only on-demand treatment.|||Bleeding events per year (ABR)||Standard Deviation|Mean
2592459|NCT02256917|Primary|Annualized Total Bleeding Rate of Individually Tailored Prophylaxis|Total annualized bleeding rate (ABR) of individually tailored prophylaxis (GENA-21b) compared to historical bleeding rate in patients having received on-demand treatment (GENA-01) with Human-cl rhFVIII|6 months|The analysis population comprised 56 patients who received at least one infusion of Human-cI rhFVIII for individualized prophylaxis in the GENA-21b trial. Their annualized bleeding rate was compared with those in patients from the completed GENA-01 trial who received only on-demand treatment.|||Bleeding events per year (ABR)||Standard Deviation|Mean
2592460|NCT02256891|Other Pre-specified|Infraspinatus Strength Measurements|Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.|24 months|There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.|||percentage of uninvolved||Standard Deviation|Mean
2592461|NCT02256891|Other Pre-specified|Infraspinatus Strength Measurements|Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.|6 months|There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.|||percentage of uninvolved||Standard Deviation|Mean
2592462|NCT02256891|Other Pre-specified|Infraspinatus Strength Measurements|Strength of infraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.|Baseline|There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.|||percentage of uninvolved||Standard Deviation|Mean
2592463|NCT02256891|Other Pre-specified|Supraspinatus Strength Measurements|Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.|24 months|There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.|||percentage of uninvolved||Standard Deviation|Mean
2592508|NCT02256111|Secondary|Effects on Serum Insulin|Mean change in fasting serum insulin between week 17 and baseline.|Baseline to 17 weeks|Only 10 in the usual care and 8 in the exercise arm patients had insulin measurements at both baseline and week 17.|||u[iU]/mL||Standard Deviation|Mean
2592464|NCT02256891|Other Pre-specified|Supraspinatus Strength Measurements|Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.|6 months|There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.|||percentage of uninvolved||Standard Deviation|Mean
2592465|NCT02256891|Other Pre-specified|MRI|"MRI was used to determine size of the defect in the proximal to distal, humeral to bursal, superior to inferior direction in all four tendons. All post operative rotator cuffs were described using the MRI rating system of Sugaya. This classification distinguishes 5 outcomes of rotator cuff repair based on integrity of the tendon determine by post operative MRI. Type I demonstrates the repaired rotator cuff has sufficient thickness and homogeneously low intensity on each image; Type II sufficient thickness with a partial high intensity area; Type III insufficient thickness without discontinuity, Type IV the presence of a minor discontinuity in more than one slice of each image suggestive of small tear; Type V the presence of a major discontinuity on each image suggestive of a large tear.~Higher grades are worse radiographic outcomes."|6 months||||scores on a scale||Standard Deviation|Mean
2592466|NCT02256891|Other Pre-specified|Spraspinatus Strength Measurements|Strength of supraspinatus in newton meters with a hand held dynomometer. Three trials were recorded and an average taken. Data is reported as measured by % of uninvolved. Average of strength measures for involved/average of strength measures for uninvolved x 100.|Baseline|There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.|||percentage of uninvolved||Standard Deviation|Mean
2592467|NCT02256891|Primary|Return to Function|Western Ontario Rotator Cuff Index|24 months|The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a 24 month measure than those that completed the entire study.|||units on a scale||Standard Deviation|Mean
2592468|NCT02256891|Primary|Return to Function|The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.|6 months||||units on a scale||Standard Deviation|Mean
2592469|NCT02256891|Primary|Return to Function|The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.|Baseline||||units on a scale||Standard Deviation|Mean
2592470|NCT02256839|Primary|Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives|To compare the clinical specificity of the CST001 assay to the QuantiFERON-TB Gold test in low TB exposure risk subjects and non TB infected subjects based on an assessment of known risk factors. These subjects had no identified risk factors of TB infection.|1 day (At time of enrollment)||||Participants|||Count of Participants
2592471|NCT02256553|Secondary|Percentage of Participants Who Experienced at Least One Local Application Site Reaction That Required Symptomatic Treatment|Events of local application site reactions included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, throat tightness, lip swelling/edema, ear pruritus, dysphagia, oral discomfort, glossodynia, oral pruritus, hypoaesthesia oral, throat irritation, paraesthesia oral or stomatitis. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the WAO as local side effects of SLIT that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.|During Period I, Period II and Period III (Up to 6 weeks)|All Treated Participants population consisted of all participants who received ≥1 dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
2592472|NCT02256553|Secondary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, was also an AE.|During Period I, Period II and Period III (Up to 6 weeks)|All Treated Participants population consisted of all participants who received ≥1 dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
2592473|NCT02256553|Secondary|Percentage of Participants Who Experienced at Least One Event of Local Application Site Reaction|Events of local application site reactions included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, throat tightness, lip swelling/edema, ear pruritus, dysphagia, oral discomfort, glossodynia, oral pruritus, hypoaesthesia oral, throat irritation, paraesthesia oral or stomatitis. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the WAO as local side effects of SLIT that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.|During Period I, Period II and Period III (Up to 6 weeks)|All Treated Participants population consisted of all participants who received ≥1 dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
2594349|NCT02233738|Secondary|SF-12 Health Survey Physical Summary Score at Baseline|Physical summary items are summed and weighed Min value:0 Max value:100 Higher score indicates higher level of health|30 days prior to Baseline||||score on a scale||Standard Deviation|Mean
2592474|NCT02256553|Primary|Percentage of Participants Who Experienced at Least One Event of Local Swelling|Events of local swelling included pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema, or throat tightness. Events that occurred during in-clinic dosing were to be monitored and recorded by clinic staff. A Side Effect Report Card was used in Periods I-III to collect information on adverse events identified by the World Allergy Organization (WAO) as local side effects of sublingual immunotherapy (SLIT) that occurred within the first 60 minutes after study drug intake. During Period I, participants were to complete the report card once a day after MK-7243 was administered. During Period II, participants were to complete the report card twice a day, once after each tablet was administered. During Period III, participants were to complete the report card once a day after both tablets were administered.|During Period I, Period II and Period III (Up to 6 weeks)|All Treated Participants population consisted of all participants who received ≥1 dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
2592475|NCT02256540|Secondary|Change in Nitrate/Nitrite Levels|Measure of nitric oxide|baseline, 1-2 hrs post-exercise||||micromolar||Standard Deviation|Mean
2592476|NCT02256540|Secondary|Gene and Protein Expression in Peripheral Blood Mononuclear Cells|No gene and protein data were analyzed.|baseline, 1-2 hours post-exercise|No data were collected for this outcome measure.||||||
2592477|NCT02256540|Primary|Percent Change in Brachial Artery Flow-mediated Dilation at Each Time Point|Brachial artery flow-mediated dilation represents the percent change in artery diameter (before and after blood pressure cuff inflation-deflation) within each time point.|Up to 2 hours post-exercise|Images were considered invalid and removed from analysis if the vascular boundaries were not able to be identified.|||Percent Change||Standard Error|Mean
2592478|NCT02256488|Secondary|Number of Subjects With Unsolicited Adverse Events|Safety was assessed as the number of subjects who reported Unsolicited Adverse Events after vaccination of TIVc and control vaccine.|Day 1 through day 22|Unsolicited Safety Set-All subjects in the exposed set with unsolicited AE data postvaccination.|||Subjects|||Number
2592479|NCT02256488|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIVc and control vaccines.|Day 1 through day 7 (without 30 min)|Solicited Safety Set-All subjects in the exposed set with any solicited AE data postvaccination or indicators of solicited AEs postvaccination|||Subjects|||Number
2592480|NCT02256488|Secondary|Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.|"Percentages of subjects achieving HI seroconversion after each of three vaccine strains were measured three weeks after vaccination of TIVc or TIVf vaccine (day 22).~Percentages of subjects who achieved HI titer ≥1:40 against each of three vaccine strains were measured three weeks after one vaccination of TIVc or TIVf vaccine.~HI assay analysis for TIVc vaccine was based on cell-based antigen and for TIVf vaccine was based on egg based antigen.~According to Center for Biologics Evaluation and Research recommendations (CBER 2007), CBER criteria are met when the lower limit of the 2-sided 95% CI for seroconversion/significant increase is ≥ 40%, and the lower limit of the 2-sided 95% CI for HI titers ≥ 1:40 is ≥ 70%."|Day 22|FAS(Full Analysis Set) All subjects in the Enrolled Population who: ▫ receive a study vaccination and provide immunogenicity data at Day 1 and at Day 22 FAS populations was analyzed “as randomized” (i.e., according to the vaccine a subject was designated to receive, which may be different from the vaccine the subject actually received).|||percentages of subjects||95% Confidence Interval|Number
2592481|NCT02256488|Primary|Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.|Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.|Day 22|Per Protocol Set(PPS) All subjects in the FAS (Full Analysis Set) Immunogenicity Population who were not excluded due to reasons defined prior to unblinding or analysis.|||Titers||95% Confidence Interval|Geometric Mean
2592482|NCT02256436|Secondary|Response Duration Per RECIST 1.1 - Participants With PD-L1 Positive Tumors|For participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1, response duration was defined as the time from first documented evidence of CR or PR until disease progression or death. Response duration for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Response duration was assessed in all participants who had PD-L1 positive tumors (CPS ≥1%) based on independent radiologist review and was analyzed using the Kaplan-Meier method.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||Full Range|Median
2592483|NCT02256436|Secondary|Response Duration Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors|For participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1, response duration was defined as the time from first documented evidence of CR or PR until disease progression or death. Response duration for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Response duration was assessed in all participants who had strongly PD-L1 positive tumors (CPS ≥10%) based on independent radiologist review and was analyzed using the Kaplan-Meier method.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized strongly PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||Full Range|Median
2592504|NCT02256267|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219||Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours|All participants who received at least 1 dose of study drug and have evaluable PK data.|||nanogram per milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
2592505|NCT02256189|Primary|Glucagon Counterregulation to Hypoglycemia|Change in plasma glucagon to insulin-induced hypoglycemia after four weeks of treatment with sitagliptin and placebo|Four weeks treatment||||pmol/l||Standard Error|Mean
2592484|NCT02256436|Secondary|Response Duration Per RECIST 1.1 - All Participants|For participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1, response duration was defined as the time from first documented evidence of CR or PR until disease progression or death. Response duration for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Response duration was assessed in all participants based on independent radiologist review and was analyzed using the Kaplan-Meier method.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||Full Range|Median
2592485|NCT02256436|Secondary|Number of Participants Who Discontinued Study Treatment Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who discontinued study treatment due to an AE was assessed.|Up to approximately 20 months|The analysis population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Participants|||Number
2592486|NCT02256436|Secondary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. Participants were monitored for the occurrence nonserious AEs for up to 30 days after last dose of study treatment and for serious AEs for up to 90 days after last dose of study treatment. The number of participants who experienced an AE was assessed.|Up to approximately 23 months|The analysis population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Participants|||Number
2592487|NCT02256436|Secondary|ORR Per Modified RECIST - All Participants|ORR per modified RECIST was defined as the percentage of participants in the analysis population who had a Complete Response (irCR: complete disappearance of all lesions [and no new lesions] confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented) or a Partial Response (irPR: decrease in tumor burden ≥50% relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation). ORR per modified RECIST was assessed by blinded independent radiologist review in all participants up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
2592488|NCT02256436|Secondary|PFS Per Modified RECIST - All Participants|PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per modified (immune-related [ir]) RECIST, progressive disease (irPD) was defined as: increase in tumor burden ≥25% relative to minimum recorded tumor burden confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented. PFS per modified RECIST was assessed by blinded independent radiologist review in all randomized participants up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2592489|NCT02256436|Secondary|ORR Per RECIST 1.1 - Participants With PD-L1 Positive Tumors|ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR was assessed by blinded independent radiologist review in participants with PD-L1 positive tumors (CPS ≥1%) up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
2592490|NCT02256436|Secondary|ORR Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors|ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR was assessed by blinded independent radiologist review in participants with strongly PD-L1 positive tumors (CPS ≥10%) up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized strongly PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
2592491|NCT02256436|Secondary|Objective Response Rate (ORR) Per RECIST 1.1 - All Participants|ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. ORR was assessed by blinded independent radiologist review in all participants up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
2592506|NCT02256111|Secondary|Effects on Body Composition|Mean change in lean body mass and fat body mass between week 17 and baseline as measured by a DEXA Scan.|Baseline to 17 weeks||||g||Standard Deviation|Mean
2592507|NCT02256111|Secondary|Effects on Blood Hemoglobin (Hgb)|Mean change in blood hemoglobin (Hgb) A1C between week 17 and baseline.|Baseline to 17 weeks|Only 10 in the usual care and 8 in the exercise arm patients had Hgb measurements at both baseline and week 17.|||percentage of glycated hemoglobin||Standard Deviation|Mean
2592492|NCT02256436|Primary|PFS Per RECIST 1.1 - Participants With PD-L1 Positive Tumors|PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 was assessed by blinded independent radiologist review in all participants who had PD-L1 positive tumors (CPS ≥1%) up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2592493|NCT02256436|Primary|OS - Participants With PD-L1 Positive Tumors|OS was defined as the time from randomization to death due to any cause. For the purposes of this study, participants with PD-L1 CPS ≥1% were considered to have a PD-L1 positive tumor status. OS was assessed in all participants who had PD-L1 positive tumors (CPS ≥1%) up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2592494|NCT02256436|Primary|PFS Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors|PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 was assessed by blinded independent radiologist review in all participants who had strongly PD-L1 positive tumors (CPS ≥10%) up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized strongly PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2592495|NCT02256436|Primary|OS - Participants With Strongly PD-L1 Positive Tumors|OS was defined as the time from randomization to death due to any cause. For the purposes of this study, participants with a programmed cell death-ligand 1 (PD-L1) combined proportion score (CPS) ≥10% were considered to have a strongly PD-L1 positive tumor status. The OS was assessed in all participants who had strongly PD-L1 positive tumors (CPS ≥10%) up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized strongly PD-L1 positive participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2592496|NCT02256436|Primary|Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - All Participants|PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was assessed by blinded independent radiologist review in all participants up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2592497|NCT02256436|Primary|Overall Survival (OS) - All Participants|OS was defined as the time from randomization to death due to any cause. The OS was assessed in all participants up through the database cutoff date of 07-Sep-2016.|Through database cutoff date of 07-Sep-2016 (Up to approximately 20 months)|The analysis population consisted of all randomized participants, regardless of whether or not they received study treatment. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2592498|NCT02256358|Primary|Emergence Agitation|The primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher.|During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes||||participants|||Number
2592499|NCT02256345|Secondary|Change in Aortic Augmentation Index|Percent change in augmentation index, whereas augmentation index at each time point (visit) is defined as the amplitude of the second peak to the first peak of the aortic pulse wave form multiplied by 100: augmentation index = (P2/P1)×100.|Baseline, end of week 1, end of week 2||||Percent change in augumentation index||95% Confidence Interval|Mean
2592500|NCT02256345|Secondary|Change in Mitochondrial Oxidative Capacity for Each Dose|Percent change in oxidative capacity (oxyhemoglobin levels) before and after occlusion|Baseline, end of week 1, end of week 2||||Percent change in oxidative capacity||95% Confidence Interval|Mean
2592501|NCT02256345|Secondary|Change in Vasodilatory Reserve for Each Dose|Percent change in peak vascular resistance from rest to peak exercise|Baseline, end of week 1, end of week 2||||%change in peak vascular resistance||95% Confidence Interval|Mean
2592502|NCT02256345|Primary|Change in Peak Oxygen Uptake (VO2) From Baseline Upto 1 Week of Administration for Each Dose|Peak oxygen uptake (VO2) defined as the average value obtained during the last 30 seconds of exercise.|Baseline, end of week 1, end of week 2||||L/min||95% Confidence Interval|Mean
2592503|NCT02256267|Primary|PK: Area Under the Concentration Time Curve AUC(0-∞) of LY2835219||Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours|All participants who received at least 1 dose of study drug and have evaluable PK data.|||nanogram x hour per mL (ng x h/mL)||Geometric Coefficient of Variation|Geometric Mean
2594350|NCT02233738|Secondary|Brief Symptom Inventory (BSI-18) at 6 Months|Min value:0 Max value:72 Higher score indicates higher psychological distress|6 months||||score on a scale||Standard Deviation|Mean
2592509|NCT02256111|Secondary|17-week Change in Muscle Cross-sectional Area (CSA)|Mean change in muscle cross sectional area of the dominant quadricep, hamstring, and total mid-thigh between week 17 and baseline. Cross-sectional area was measured using magnetic resonance imaging with a 3.0T-scanner.|Baseline to 17 weeks|Only 10 in the usual care and 8 in the exercise arm patients had cross-sectional area measurements performed at both measurement time points.|||cm^2||Standard Deviation|Mean
2592510|NCT02256111|Secondary|17-week Change in Functional Capacity as Measured by Six Minute Walk Test|Mean change in distance covered during the six minute walk test between week 17 and baseline. This test requires patients to cover the longest distance possible in six minutes under the supervision of an exercise physiologist or designee.|Baseline to 17 weeks|Two patients in the usual care arm did not complete the test at both baseline and week 17|||meters||Standard Deviation|Mean
2592511|NCT02256111|Secondary|17-week Change in Functional Capacity as Measured by Time Up and Go Test|Mean change in number of seconds to complete the timed up and go test between week 17 and baseline. This test requires patients to stand up from a chair with armrests, walk 3m, turn around, return to the chair, and sit down|Baseline to 17 weeks|One patient in the usual care arm did not complete the test at week 17|||seconds||Standard Deviation|Mean
2592512|NCT02256111|Secondary|Attrition Rate|Attrition rate is defined as the percent of subjects who complete the 16 week exercise training program. This outcome applies only to the exercise arm.|16 weeks||||percentage of participants|||Number
2592513|NCT02256111|Secondary|Adherence Rate|Adherence rate is defined as the percentage of days that each patient fulfilled the assigned exercise prescription of the 48 days. The median percentage is reported.|48 days||||percentage of days||Full Range|Median
2592514|NCT02256111|Secondary|Acceptance Rate|Acceptance rate is defined as the number of patients agreeing to participate divided by total number randomized. This is reported as a percent.|29 months from study initiation||||percentage of participants|||Number
2592515|NCT02256111|Secondary|Eligibility Rate|Eligibility rate is defined as the number of subjects found to be eligible divided by the number approached for the study. Note that ineligible subjects are not randomized. This is reported as a percent.|29 months from study initiation|This overall number of participants analyzed reflects the total number of individuals approached for this study.|||percentage of participants|||Number
2592516|NCT02256111|Secondary|Change in the Effect on Patient Reported Outcomes (PROs) of Interest Over Time|Mean change in PROs aggregate score between week 17 and baseline. PROs include the FACT-Prostate (FACT-P, range 0 to 104), FACIT-Fatigue (FACIT-F, range 0 to 52), and the Godin Leisure Questionnaire. Higher scores indicate better quality of life.|Baseline to 17 weeks||||score on a scale||Standard Deviation|Mean
2592517|NCT02256111|Secondary|Effects on Serum Glucose|Mean change in fasting serum glucose between week 17 and baseline.|Baseline to 17 weeks|Only 10 in the usual care and 8 in the exercise arm patients had glucose measurements at both baseline and week 17.|||mg/dL||Standard Deviation|Mean
2592518|NCT02256111|Secondary|17-week Change in Upper and Lower Extremity Maximal Muscular Strength|Mean change in upper and lower extremity maximal muscular strength as measured by the voluntary one-repetition max (1-RM) and muscular endurance as measured by 70% of 1-RM between week 17 and baseline|Baseline to 17 weeks|1 patient out of 13 did not complete the 1-RM at baseline or week 17 in the usual care arm, and another did not complete the 70% 1-RM at week 17 out of 12|||pounds||Standard Deviation|Mean
2592519|NCT02256111|Secondary|17-week Change in Functional Capacity as Measured by Chair-stand Test|Mean change in number of seconds to perform the chair-stand test between baseline and week 17. This test measures the time taken to complete 5 repetitions of the sit-to-stand maneuver from a chair without an arm rest at 43 cm in height and 47.5 cm in depth. This test provides an indicator of functional performance of lower body strength; quicker times indicate greater strength|Baseline to 17 weeks|One patient in the usual care arm did not complete the test at week 17|||seconds||Standard Deviation|Mean
2592520|NCT02256111|Primary|Change in VO2peak in Usual Care Versus Exercise Training Arms|Mean change in peak oxygen uptake (VO2peak) from week 1 to week 17 in the usual care and exercise training groups|From week 1 to week 17||||mL/kg/min||Standard Deviation|Mean
2592521|NCT02256072|Secondary|Satisfaction With Intervention Tool Score at Immediate Post-test, 1 and 3-months|"Overall satisfaction with the intervention or attention control as measured by the Satisfaction with Intervention Tool. Tests will be performed at a two-sided 5% significance level."|baseline, post-intervention, 1 month, and 3 months|Due to errors in the data collection method, it is not possible to summarize the data for reporting.||||||
2592522|NCT02256072|Secondary|Knowledge of Home Services Score at Immediate Post-test, 1 and 3-months|"Knowledge of home services score at all follow-up time points as measured by Understanding of Home Services assessment. This is a 6-item knowledge assessment; each question is scored as correct or incorrect and questions are equally weighted. The total possible range of scores is 0-6,with 0 being low knowledge and 6 being high."|baseline, post-intervention, 1 month, and 3 months|Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.|||units on a scale||Standard Deviation|Mean
2592523|NCT02256072|Secondary|Confidence in Accessing Home Services Score at Immediate Post-test, 1 and 3-months|Participant confidence in accessing home services based on a 5-item questionnaire. The score is the equally-weighted sum of responses to the five questions in the CAHS instrument. Each question has a scale of 1-5, giving a total possible range of 5-25, with 5 representing low confidence and 25 representing high confidence. No subscores are calculated.|baseline, post-intervention, 1 month, and 3 months|Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.|||units on a scale||Standard Deviation|Mean
2592524|NCT02256072|Secondary|Planning Perception Score at Baseline, Immediate Post-test, 1 and 3-months|"Planning perception score (ranging from 5-25 points where higher values are considered to be a better outcome) at all follow-up time points as measured by the Planning Perception assessment. This secondary outcome measure will be assessed at baseline, immediate post-test, 1, and 3-months."|baseline, post-intervention, 1 month, and 3 months|Participants with a complete baseline planning behavior score and either a complete one-month or three-month planning behavior score.|||units on a scale||Standard Deviation|Mean
2593120|NCT02249065|Secondary|Inflammatory Lesions|Change from baseline in facial inflammatory lesion count|14 days (Day 1 (Baseline) and Day 14/Exit)|ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment|||lesions||Standard Deviation|Mean
2592525|NCT02256072|Primary|Planning Behavior Score at 1-month|"The primary endpoint for this study is planning behavior score (ranging from 5-25 points; where higher values are considered to be a better outcome) at one month post-intervention/attention control as measured by the Planning Implementation (Behavior) assessment. The outcome measure will be assessed at baseline and one month from baseline. Primary endpoint analyses will consist of an analysis of covariance (ANCOVA) comparing mean planning behavior score at one month post-intervention/attention control while controlling for baseline planning behavior score. All analyses will assume a type I error rate of 5%."|baseline and 1 month|All randomized participants with a complete planning behavior score at baseline and one-month.|||units on a scale||Standard Deviation|Mean
2592526|NCT02255981|Secondary|Number of Participants With Adverse Events Both Treatment-related or Not Related to Treatment.|To report this measure the adverse events or risks had to be observed carefully and registered in order to care for the safety and to accomplish regulations of any treatment or medical intervention. For this procedure, the usual risks are some adverse events as moderate to severe pain, bleeding of more than a drop, ecchymosis bigger than 5 millimeters. Deaths and other serious events related or not with the therapeutic procedure, had to be reported.|2 years|Participants who suffered some adverse event as moderate to severe pain, bleeding of more than a drop, ecchymosis bigger than 5 millimeters. Deaths and other events related or not with the therapeutic procedure.|||participants|||Number
2592527|NCT02255981|Secondary|Percentage of Participants Who Experienced Changes in Vision (Less Opacity, Less Distortion of Lines, Reduction of the Central Shadow)|At study entry, major complaints of patients were collected by survey. Participants also completed a survey at the middle and at the end of the trial. This data is the percentage of participants that reported changes to the main visual complaints that they considered significant in their lives compared with the baseline.|Baseline and end of study (up to 2 years)|All the participants who had a follow up for 24 months filled a survey about their complains and limitation in daily life at the beginning, in the middle time and at the end of the study. The measure is the number of patients who reported improvement.|||percentage of participants improved|||Number
2592528|NCT02255981|Primary|Number of Eyes That Improved VA From Baseline to End of the Study in Participants With Different Forms of Macular Disease Treated With Acupuncture.|"Improved was defined as cases that gained in visual acuity (Note: no minimum of letters was defined). Stable was defined as visual acuity did not change in the sense of not losing or gaining in the final identification of the optotypes. Lost was defined as patients who had a worse vision at the end than at the beginning (e.g., lost visual acuity because the disease continued its course and the treatment was not effective.)"|2 years|Patients with AMD can have both eyes with neovascular AMD or NV-AMD in one of the eyes and No NA-AMD in the fellow.|||eyes|eyes||Number
2592529|NCT02255981|Primary|Change From Baseline in the Number of Letters Seen on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart|The ETDRS scale of letters is commonly used to report outcomes in AMD, for this reason, this score was chosen to compare outcomes with similar studies. Accepted tables for conversion from Snellen to ETDRS were used. 85 letters are equivalent to 20/20 and 0 letters correspond to 20/200. It can be meaningful to analyze the results in this trial in the context of similar trials using anti-VEGF, or reporting a visual loss in those cases that are not treatable.|Baseline and at end of study (up to 2 years)|"In AMD patients, some had a form in one eye and other in the fellow. Improved means the eyes which improved based on the number of letters gained in the ETDRS chart over the baseline and maintained for the end of the study. Stable if the number of letters is almost the same and lost if it was reduced."|||Letters on ETDRS scale|eyes|Standard Deviation|Mean
2592530|NCT02255981|Primary|Eyes With Change From Baseline to the End of the Study in Distance Vision According to Categories CIE 10 Based on Lines Seen on the Snellen Chart.|"Change in Visual Acuity was Measured by the Numbers of Lines seen on the Snellen Chart from baseline to the end of the trial. The measure was obtained by an ophthalmologic assessment on both eyes at the beginning of the study and every two months until month 24 using the best correction. VA measurements (lines in which all letters are correctly identified) were performed with the patient in a sitting position using a Snellen chart at a testing distance of 6 meters and the variation is appreciated by the lines gained or lost by each eye. The measure in Snellen is given in fractional numbers. Each fraction corresponds to a determined line of the chart corresponding VA 20/20 or 6/6 to a normal vision at 20 ft or 6 meters. The range of normal vision according to the WHO is to 20/25 ft or 6/10m, Mild means VA worse than 6/12, Moderate means VA worse than 6/18, Severe means VA worse than 6/60 that is legal blindness. Blindness is considered VA worse than 3/60."|24 months from baseline.|All participants received the same treatment in a treat and extend regimen with an ophthalmological review every 2 months for 2 years. Data of VA from baseline to the end of the study were compared to assess Improvement or worsening. Improved means eyes with a better score of lines, stable means equal VA and worse is a loss of lines seen.|||Eyes|Eyes||Count of Units
2592531|NCT02255981|Primary|Change on Visual Acuity (VA) of the Treated Eyes From Baseline to the End of the Study|"The primary objective is to assess if acupuncture treatment is linked to a change in visual acuity (VA).~VA was obtained by an ophthalmologic assessment at baseline and every two months until month 24. VA measurements were taken with the patient in a sitting position using a Snellen chart at a testing distance of 6 meters. The scale in Snellen is given in fractional numbers corresponding 20/20 to a normal vision at 20 ft or 6 meters. According to the World Health Organization, the normal vision is to 20/25, severe impairment corresponds to VA worse than 20/200 or legal blindness. Each fraction corresponds to a determined line of the chart in which all letters are correctly identified and the variation or gain is appreciated by the lines gained or lost by each eye.~Improvement means a fraction better than initial, stable is no change in VA and lost is the VA worst than those of baseline."|Baseline, 2 months and every 2 months until month 24.|The primary analysis includes only patients who completed the 24-month exam. The improvement in this outcome is measured on eyes which had a vision gain in lines of the Snellen chart.|||Eyes|Eyes||Count of Units
2592532|NCT02255760|Secondary|Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI3902|Blood samples were collected to evaluate the antidrug antibody responses to MEDI3902 in serum. The number of participants positive for serum antibodies to MEDI3902 were presented.|Days 1 (pre-dose), 15, 29, and 61|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2592533|NCT02255760|Secondary|MEDI3902 Serum Clearance (CL) of MEDI3902|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. The PK parameter CL was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.|Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||milliliters/day||Standard Deviation|Mean
2592534|NCT02255760|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug uniformly distributed to produce the desired serum concentration of a drug. The PK parameter Vss was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.|Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||milliliters||Standard Deviation|Mean
2592535|NCT02255760|Secondary|Terminal Phase Elimination Half-life (t1/2)|The t1/2 is the time measured for the serum drug concentration of MEDI3902 to decrease by one half. The PK parameter t1/2 was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.|Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Days||Standard Deviation|Mean
2592536|NCT02255760|Secondary|Maximum Observed Serum Concentration (Cmax) for MEDI3902 After First Dose|The PK parameter Cmax was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.|Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||micrograms/milliliter||Standard Deviation|Mean
2592537|NCT02255760|Secondary|Area Under the Serum Concentration-time Curve From Zero to Infinity (AUC [0-infinity])|Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). The PK parameter AUC (0-inf) was estimated based on the serum concentrations of MEDI3902. Non-compartmental PK data analysis was performed to estimate the serum PK parameters of MEDI3902.|Pre-dose (24 hours prior to dose); at the end of the infusion, and 8 hours post infusion, and Days 2, 3, 7, 15, 22, 29, 43, and 61 post-dose|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||micrograms*day/milliliters||Standard Deviation|Mean
2592538|NCT02255760|Primary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital signs measurements included temperature, blood pressure (systolic and diastolic), pulse rate and respiratory rate.|Day 1 to Day 7|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2592539|NCT02255760|Primary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)|Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: Hematology, serum chemistry, liver function, serum electrolytes and urinalysis.|Day 1 to Day 29|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2592540|NCT02255760|Primary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment Emergent Adverse Events of Special Interest (TEAESIs)|An AE is any untoward medical occurrence attributed to study drug in a participant who received investigational product. TESAE was an event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly that occurred after the initial receipt of the study drug. An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. TEAESIs were collected from the time of dosing through Day 61 after the last dose of study drug and included anaphylaxis, other serious allergic reactions, infusion-related reactions, hepatic function abnormalities and immune complex disease.|Day 1 to Day 61|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2592541|NCT02255760|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE is defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.|Day 1 to Day 29|Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.|||Participants|||Count of Participants
2592542|NCT02255565|Secondary|Clinical Global Impression - Improvement (CGI-I)|The CGI-I scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse.|once a week for 6 weeks||||units on a scale||Standard Deviation|Mean
2592543|NCT02255565|Secondary|Clinical Global Impressions-ADHD - Severity|The CGI-S scale summarizes the clinician's impression of the participant's symptom severity and ranges from 1-7 with 1 representing normal (not at all ill) and 7 representing extremely ill.|once a week for 6 weeks||||units on a scale||Standard Deviation|Mean
2594351|NCT02233738|Secondary|Brief Symptom Inventory (BSI-18) at 3 Months|Min value:0 Max value:72 Higher score indicates higher psychological distress|3 months||||score on a scale||Standard Deviation|Mean
2592544|NCT02255565|Primary|ADHD Rating Scale - IV|Measures the severity of Total ADHD symptoms, Inattention and Hyperactivity/Impulsive symptoms. The Inattention and Hyperactivity/Impulsive symptoms can range from 0 to 27 each, with a higher score reflecting more severe ADHD symptoms. The total score is calculated by summing the inattention and Hyperactivity/Impulsive subscales. The total score can range from 0 to 54 with a higher score reflecting more severe ADHD symptoms.|once a week for 6 weeks||||units on a scale||Standard Deviation|Mean
2592545|NCT02255461|Other Pre-specified|Polymorphisms in Breast Cancer Resistance Protein (BCRP; ABCG2)|Polymorphisms in ABCG2 encode for BCRP, for which palbociclib has been shown as a substrate. Genomic DNA was to be isolated from peripheral blood samples from consenting patients to determine ABCG2 polymorphisms.|At enrollment|||||||
2592546|NCT02255461|Other Pre-specified|Polymorphisms in Efflux-transporter Proteins P-glycoprotein (P-gp; ABCB1)|Polymorphisms in ABCB1 encode for efflux-transporter proteins P-glycoprotein (P-gp), for which palbociclib has been shown as a substrate. Genomic DNA was to be isolated from peripheral blood samples from consenting patients to determine ABCB1 polymorphisms.|At enrollment|||||||
2592547|NCT02255461|Other Pre-specified|Number of Subjects With Ink4a-ARF Loss Copy Number Variations|Ink4a-ARF is a key component in signaling pathways inside normal cells and cancer cells. Ink4a-ARF loss copy number variations were to be assessed by array comparative genomic hybridization in available tumor tissues from consenting patients.|At enrollment|||||||
2592548|NCT02255461|Other Pre-specified|Number of Subjects With Cyclin D3 Copy Number Variations|Cyclin D3 is a key component in signaling pathways inside normal cells and cancer cells. Cyclin D3 copy number variations were to be assessed by array comparative genomic hybridization in available tumor tissues from consenting patients.|At enrollment|||||||
2592549|NCT02255461|Other Pre-specified|Number of Subjects With Cyclin D2 Copy Number Variations|Cyclin D2 is a key component in signaling pathways inside normal cells and cancer cells. Cyclin D2 copy number variations were to be assessed by array comparative genomic hybridization in available tumor tissues from consenting patients.|At enrollment|||||||
2592550|NCT02255461|Other Pre-specified|Number of Subjects With Cyclin D1 Copy Number Variations|Cyclin D1 is a key component in signaling pathways inside normal cells and cancer cells. Cyclin D1 copy number variations were to be assessed by array comparative genomic hybridization in available tumor tissues from consenting patients.|At enrollment|||||||
2592551|NCT02255461|Other Pre-specified|Number of Subjects With Cyclin-dependent Kinase-6 (CDK6) Copy Number Variations|CDK6 is a key component in signaling pathways inside normal cells and cancer cells. CDK6 copy number variations were to be assessed by array comparative genomic hybridization in available tumor tissues from consenting patients.|At enrollment|||||||
2592552|NCT02255461|Other Pre-specified|Number of Subjects With Cyclin-dependent Kinase-4 (CDK4) Copy Number Variations|CDK4 is a key component in signaling pathways inside normal cells and cancer cells. CDK4 copy number variations were to be assessed by array comparative genomic hybridization in available tumor tissues from consenting patients.|At enrollment|||||||
2592553|NCT02255461|Secondary|Association Between Leukopenia and Single Dose Palbociclib AUC|White blood cell count decreased adverse events observed in course 1 that were at least possibly attributable to palbociclib were included in analysis. Based on the highest toxicity grade reported, all participants, irrespective of their dose level or stratum, were combined and classified into three categories: 0 = no toxicity reported, 1 = grade 1 or 2, and 2 = grade 3 or 4. Association between white blood cell count decreased and single dose palbociclib AUC for all participants was examined.|Up to approximately 4 weeks|It was pre-specified that data from all participants from different dose levels and strata were combined to calculate an association between leukopenia and single dose AUC for all participants. Of 35 patients enrolled, one patient in stratum II withdrew prior to protocol therapy and was excluded.|||h*ng/mL||Standard Deviation|Mean
2592554|NCT02255461|Secondary|Association Between Lymphopenia and Single Dose Palbociclib AUC|Lymphocyte count decreased adverse events observed in course 1 that were at least possibly attributable to palbociclib were included in analysis. Based on the highest toxicity grade reported, all participants, irrespective of their dose level or stratum, were combined and classified into three categories: 0 = no toxicity reported, 1 = grade 1 or 2, and 2 = grade 3 or 4. Association between Lymphocyte count decreased and single dose palbociclib AUC for all participants was examined.|Up to approximately 4 weeks|It was pre-specified that data from all participants from different dose levels and strata were combined to calculate an association between lymphopenia and single dose AUC for all participants. Of 35 patients enrolled, one patient in stratum II withdrew prior to protocol therapy and was excluded.|||h*ng/mL||Standard Deviation|Mean
2592555|NCT02255461|Secondary|Association Between Neutropenia and Single Dose Palbociclib AUC|Neutrophil count decreased adverse events observed in course 1 that were at least possibly attributable to palbociclib were included in analysis. Based on the highest toxicity grade reported, all participants, irrespective of their dose level or stratum, were combined and classified into three categories: 0 = no toxicity reported, 1 = grade 1 or 2, and 2 = grade 3 or 4. Association between neutrophil count decreased and single dose palbociclib AUC for all participants was examined.|Up to approximately 4 weeks|It was pre-specified that data from all participants from different dose levels and strata were combined to calculate an association between neutropenia and single dose AUC for all participants. Of 35 patients enrolled, one patient in stratum II withdrew prior to protocol therapy and was excluded.|||h*ng/mL||Standard Deviation|Mean
2592556|NCT02255461|Secondary|Number of Subjects With Objective Responses|Objective responses included complete response (CR) and partial response (PR).|Up to 2 years|Patients who received at least one dose of palbociclib were included in the analysis. One patient in stratum II dose level 2 who withdrew prior to beginning protocol therapy was excluded.|||Participants|||Count of Participants
2592557|NCT02255461|Primary|Steady State Area Under the Plasma Concentration Time Curve (AUC)|On day 21 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 1, 2, 4, 8 (±1), 10 (±0.5) optional, and 24 (±4) hours after the dose. Area under the plasma concentration time curve (AUC) was estimated using a non-compartmental method.|Up to day 22|Patients with blood samples collected for pharmacokinetic studies on days 21-22 of course 1 were included.|||h*ng/mL||Full Range|Median
2593039|NCT02249949|Secondary|Overall Survival|Overall survival time is defined as the time from study entry to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Time from study entry to death from any cause, assessed up to 5 years||||months||95% Confidence Interval|Median
2592558|NCT02255461|Primary|Steady State Apparent Oral Clearance (CL/F)|On day 21 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 1, 2, 4, 8 (±1), 10 (±0.5) optional, and 24 (±4) hours after the dose. Apparent oral clearance (CL/F) was estimated using a non-compartmental method.|Up to day 22|Patients with blood samples collected for pharmacokinetic studies on days 21-22 of course 1 were included.|||L/h/m^2||Full Range|Median
2592559|NCT02255461|Primary|Steady State Half-life (t1/2)|On day 21 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 1, 2, 4, 8 (±1), 10 (±0.5) optional, and 24 (±4) hours after the dose. Half-life (t1/2) was estimated using a non-compartmental method.|Up to day 22|Patients with blood samples collected for pharmacokinetic studies on days 21-22 of course 1 were included.|||hour||Full Range|Median
2592560|NCT02255461|Primary|Steady State Elimination Rate Constant (Ke)|On day 21 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 1, 2, 4, 8 (±1), 10 (±0.5) optional, and 24 (±4) hours after the dose. Elimination rate constant (Ke) was estimated using a non-compartmental method.|Up to day 22|Patients with blood samples collected for pharmacokinetic studies on days 21-22 of course 1 were included.|||per hour||Full Range|Median
2592561|NCT02255461|Primary|Steady State Apparent Volume of Central Compartment (Vc/F)|On day 21 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 1, 2, 4, 8 (±1), 10 (±0.5) optional, and 24 (±4) hours after the dose. Apparent volume of central compartment (Vc/F) was estimated using a non-compartmental method.|Up to day 22|Patients with blood samples collected for pharmacokinetic studies on days 21-22 of course 1 were included.|||L/m^2||Full Range|Median
2592562|NCT02255461|Primary|Single Dose Area Under the Plasma Concentration Time Curve (AUC)|On day 1 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 0.5, 1, 2, 4, 8 (±1), 10 (±0.5) optional, 24 (±4), 48 (±4) hours after the oral dose of palbociclib. Area under the plasma concentration time curve (AUC) was estimated using a non-compartmental method.|Up to day 3|Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included.|||h*ng/mL||Full Range|Median
2592563|NCT02255461|Primary|Single Dose Apparent Oral Clearance (CL/F)|On day 1 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 0.5, 1, 2, 4, 8 (±1), 10 (±0.5) optional, 24 (±4), 48 (±4) hours after the oral dose of palbociclib. Apparent oral clearance (CL/F) was estimated using a non-compartmental method.|Up to day 3|Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included.|||L/h/m^2||Full Range|Median
2592564|NCT02255461|Primary|Single Dose Half-life (t1/2)|On day 1 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 0.5, 1, 2, 4, 8 (±1), 10 (±0.5) optional, 24 (±4), 48 (±4) hours after the oral dose of palbociclib. Half-life (t1/2) was estimated using a non-compartmental method.|Up to day 3|Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included.|||hour||Full Range|Median
2592565|NCT02255461|Primary|Single Dose Elimination Rate Constant (Ke)|On day 1 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 0.5, 1, 2, 4, 8 (±1), 10 (±0.5) optional, 24 (±4), 48 (±4) hours after the oral dose of palbociclib. Elimination rate constant (Ke) was estimated using a non-compartmental method.|Up to day 3|Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included.|||per hour||Full Range|Median
2592566|NCT02255461|Primary|Single Dose Apparent Volume of Central Compartment (Vc/F)|On day 1 of course 1, series blood samples for palbociclib pharmacokinetic studies were collected at pre-dose, 0.5, 1, 2, 4, 8 (±1), 10 (±0.5) optional, 24 (±4), 48 (±4) hours after the oral dose of palbociclib. Apparent volume of central compartment (Vc/F) was estimated using a non-compartmental method.|Up to day 3|Patients with blood samples collected for pharmacokinetic studies on days 1-3 of course 1 were included.|||L/m^2||Full Range|Median
2592567|NCT02255461|Primary|Number of Patients Who Experienced Dose Limiting Toxicities (DLTs)|DLTs were defined as any of the following adverse events that were at least possibly related to palbociclib that occurred during the first 4 weeks of therapy regardless of expectedness. Hematologic DLTs included grade 3 neutropenia with fever and sepsis, grade 3 thrombocytopenia and/or requiring a platelet transfusion on 2 separate days within a 7-day period, or any grade 4 hematologic toxicity except lymphopenia. Non-hematologic DLTs included any grade 4 non-hematologic toxicity, any grade 3 non-hematologic toxicity with some exceptions (e.g., nausea and vomiting of < 5 days; diarrhea and/or electrolyte disturbances which have not been maximally treated; AST/ALT elevation that returns to levels meeting eligibility criteria within 7 days of study drug interruption and does not recur upon restarting drug), or any grade 2 non-hematologic toxicity that persists for > 7 days and is considered medically significant or sufficiently intolerable by patients requires treatment interruption.|4 weeks|Patients who received at least one dose of palbociclib were included in the analysis. One patient in stratum II dose level 2 who withdrew prior to beginning protocol therapy was excluded.|||Participants|||Count of Participants
2592568|NCT02255461|Primary|Maximum Tolerated Dose (MTD) of Palbociclib in Stratum II|Rolling-6 design was used to estimate MTD. The MTD was empirically defined as the highest dose level at which six patients were treated with at most one patient experiencing a DLT and the next higher dose level had been determined to be too toxic. Stratum II consisted of heavily pre-treated patients.|4 weeks|Patients who were enrolled on stratum II and were evaluable for dose finding assessment were used to determine the MTD for stratum II.|||mg/m2/day|||Number
2592569|NCT02255461|Primary|Maximum Tolerated Dose (MTD) of Palbociclib in Stratum I|Rolling-6 design was used to estimate MTD. The MTD was empirically defined as the highest dose level at which six patients were treated with at most one patient experiencing a dose-limiting toxicity (DLT) and the next higher dose level had been determined to be too toxic. Stratum I consisted of less-heavily pre-treated patients.|4 weeks|Patients who were enrolled on stratum I and were evaluable for dose finding assessment were used to determine the MTD for stratum I.|||mg/m2/day|||Number
2592570|NCT02255357|Primary|Number of Consecutive Weeks of Abstinence From Cocaine After Abstinence Induction||Up to 6 weeks||||weeks||Inter-Quartile Range|Mean
2592959|NCT02251912|Primary|Mean Weekly Drinks Per Drinking Day|The mean number of standard drinks (the amount of alcohol in a standard drink is roughly equivalent to the amount of alcohol in a 12 ounce beer) consumed by subjects on days when they drank alcoholic beverages each week averaged over the 12-week trial.|12 weeks||||number of drinks per drinking day||Standard Error|Least Squares Mean
2592571|NCT02255279|Secondary|Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.|Percentage of subjects with a HI titer ≥ 40, ≥110 and ≥330 on Day 1, Day 22 (non naïve subjects) or Day 50 (naïve subjects), in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age.|Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination|Analysis performed on the Per Protocol Set.|||Percentage of subjects||95% Confidence Interval|Number
2592572|NCT02255279|Secondary|Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.|GMRs of HI, day 22/day 1 (non-naive subjects) or day 50/day 1 (naive subjects) in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age. As the non-inferiority of aTIV to TIV has been established, GMT ratio of aTIV relative to TIV in all three homologous virus strains, 21 days after last immunization in subjects 6 to <72 months of age was evaluated using margins greater than the non-inferiority cut-off of 0.67.|Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination|Analysis performed on the Per Protocol Set.|||Ratios||95% Confidence Interval|Geometric Mean
2592573|NCT02255279|Secondary|Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.|Percentages of subjects with seroconversion in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age, defined as: HI ≥ 40 subject with a pre-vaccination HI titer <10; a minimum 4-fold increase HI titer for subjects with a prevaccination HI titer ≥10, on Day 22 (non-naive subjects) or Day 50 (naive subjects), as applicable.|Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination|Analysis performed on the Per Protocol Set.|||Percentages of subjects||95% Confidence Interval|Number
2592574|NCT02255279|Primary|Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age.|"Antibody response was assessed in terms of GMTs in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age.~The study is considered a success if the 21 days after last immunization GMT ratios of aTIV relative to TIV demonstrate as non-inferior with the lower limit (LL) of the two sided 95% confidence interval (CI) above 0.67 (-0.176 on log10 scale) for each vaccine strain (Center for Biologics Evaluation and Research {CBER} Guideline on Seasonal Vaccines May 2007)."|Day 1 and Day 22 (vaccine non-naïve subjects) or Day 50 (vaccine naïve subjects) post vaccination|Analysis performed on the Per Protocol Set.|||Titers||95% Confidence Interval|Geometric Mean
2592575|NCT02255279|Primary|Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22|Number of non-naive subjects aged 6 to < 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and SAEs from Day 1 to Day 22.|From Day 1 to Day 22|Analysis performed on the Unsolicited Safety Set.|||Participants|||Number
2592576|NCT02255279|Primary|Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50.|Number of naive subjects aged 6 to < 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and serious AEs (SAEs) from Day 1 to Day 50.|From Day 1 to Day 50|Analysis performed on the Unsolicited Safety Set.|||Participants|||Number
2592577|NCT02255279|Primary|Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.|Number of non-naive subjects ≥36 months to < 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.|From Day 1 to Day 7|Analysis performed on the Solicited Safety Set.|||Participants|||Number
2592578|NCT02255279|Primary|Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.|Number of naive subjects ≥ 36 months to < 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.|From Day 1 to Day 7 by vaccination|Analysis performed on the Solicited Safety Set.|||Participants|||Number
2592579|NCT02255279|Primary|Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination.|Number of non-naive subjects 6 to < 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.|From Day 1 to Day 7|Analysis performed on the Solicited Safety Set.|||Participants|||Number
2592580|NCT02255279|Primary|Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination.|Number of naive subjects 6 to < 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.|From Day 1 to Day 7 by vaccination|Analysis performed on the Solicited Safety Set.|||Participants|||Number
2592581|NCT02255175|Secondary|Change in Inventory of Depression and Anxiety Symptoms (IDAS) Dysphoria Scores|"The Dysphoria Scale of the Inventory of Depression and Anxiety Symptoms (IDAS) will be used to assess the change in depressive symptom severity. The IDAS Dysphoria Scale consists of 10 items and uses a 5-point Likert-type scale, ranging from 1 to 5 with 1 indicating not at all and 5 indicating extremely. As such, the range of possible scores is 10 to 50. The Dysphoria scale includes items assessing feelings of depression, inadequacy, psychomotor agitation, guilt, discouragement, anhedonia, poor concentration, difficulty with decision-making, psychomotor retardation, and worry. Higher scores indicate worse depression symptoms."|Assessed at pre- and post-treatment (visits 3 and 6)||||score on a scale||Standard Error|Mean
2592582|NCT02255175|Secondary|Response Latency to Reward During the MID fMRI Task Following Estradiol Treatment|"Time (ms) between stimulus and response will be measured during reward trials of the Monetary Incentive Delay (MID) task. During MID the task, participants need to select the correct response during win and lose conditions by pressing a button on a button box in the MRI."|Post-treatment (visit 6)||||Milliseconds||Standard Deviation|Mean
2592583|NCT02255175|Secondary|Response Latency to Reward During the MID fMRI Task at Pre-treatment|"Time (ms) between stimulus and response will be measured during the Monetary Incentive Delay (MID) task during the win trials. During MID the task, participants need to select the correct response during win and lose conditions by pressing a button on a button box in the MRI."|Pre-treatment (visit 3)||||Milliseconds||Standard Deviation|Mean
2592584|NCT02255175|Primary|Putamen Signal Intensity in Response to Reward During the MID fMRI Task Following Estradiol Treatment.|"Putamen reactivity to reward during the Monetary Incentive Delay (MID) task was measured between the two groups. During MID the task, participants respond to win trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared between the two groups following treatment."|Post-treatment (visit 6)||||percent signal change||Standard Deviation|Mean
2592585|NCT02255175|Primary|Nucleus Accumbens (NAcc) Signal Intensity in Response to Reward During the MID fMRI Task Following Estradiol Treatment.|"Nucleus accumbens (NAcc) reactivity to reward during the Monetary Incentive Delay (MID) task was measured between the two groups. During MID the task, participants respond to win trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared between the two groups following treatment."|Post-treatment (visit 6)||||percent signal change||Standard Deviation|Mean
2592586|NCT02255175|Primary|Caudate Signal Intensity in Response to Reward During the MID fMRI Task Following Estradiol Treatment.|"Caudate reactivity to reward during the Monetary Incentive Delay (MID) task was measured between the two groups. During MID the task, participants respond to win trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared between the two groups following treatment."|Post-treatment (visit 6)||||percent signal change||Standard Deviation|Mean
2592587|NCT02255175|Primary|Putamen Signal Intensity in Response to Reward During the MID fMRI Task at Pre-treatment|"Putamen reactivity to reward during the Monetary Incentive Delay (MID) task was measured between the two groups. During MID the task, participants respond to win trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared between the two groups at pre-treatment."|Pre-treatment (visit 3)||||percent signal change||Standard Deviation|Mean
2592588|NCT02255175|Primary|Nucleus Accumbens (NAcc) Signal Intensity in Response to Reward During the MID fMRI Task at Pre-treatment|"Nucleus Accumbens (NAcc) reactivity to reward during the Monetary Incentive Delay (MID) task was measured between the two groups. During MID the task, participants respond to win trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared between the two groups at pre-treatment."|Pre-treatment (visit 3)||||percent signal change||Standard Deviation|Mean
2592589|NCT02255175|Primary|Caudate Signal Intensity in Response to Reward During the MID fMRI Task at Pre-treatment|"Caudate reactivity to reward during the Monetary Incentive Delay (MID) task was measured between the two groups. During MID the task, participants respond to win trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared between the two groups at pre-treatment."|Pre-treatment (visit 3)||||percent signal change||Standard Deviation|Mean
2592590|NCT02255149|Primary|Bone Height|Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images.|5 months||||millimeters||Full Range|Mean
2592591|NCT02255110|Secondary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) (Safety Run-In Phase)|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the stud drug.|From baseline until end of trial, assessed up to Day 210|The SAF Analysis Set included all subjects who received at least 1 dose of either TH-302 or doxorubicin.|||Subjects|||Number
2605756|NCT02107014|Primary|Change in IL-8 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2592592|NCT02255110|Secondary|Overall Survival (OS) (Phase II Treatment Period)|OS is defined as the time from first dose to death due to any cause.|From first dose of study drug administration until the last subject completes the survival follow-up, assessed up to 12 months|As the study was terminated early following the discontinuation of the TH-302 clinical development program, it was decided as per Statistical Analysis Plan not to collect and evaluate the efficacy data for this study||||||
2592593|NCT02255110|Secondary|Duration of Response (Phase II Treatment Period)|Duration of response according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) is defined as the time from the first assessment of complete response (CR) or partial response (PR) until the date of the first occurrence of progressive disease (PD), or until the date of death. CR: Disappearance of all evidence of target and non-target lesions. Any pathological lymph nodes must have reduction in short axis to less than (<) 10 millimeter (mm). PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.|From first dose of study drug administration until PD or death, assessed up to 12 months|As the study was terminated early following the discontinuation of the TH-302 clinical development program, it was decided as per Statistical Analysis Plan not to collect and evaluate the efficacy data for this study||||||
2592594|NCT02255110|Secondary|Best Overall Response (BOR) by Investigator (Phase II Treatment Period)|BOR was planned to be determine according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and as adjudicated by an Independent Central Review. BOR is defined as the best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression or recurrence (taking the smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 millimeter (mm). PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions.|From first dose of study drug administration until PD or death, assessed up to 12 months|As the study was terminated early following the discontinuation of the TH-302 clinical development program, it was decided as per Statistical Analysis Plan not to collect and evaluate the efficacy data for this study||||||
2592595|NCT02255110|Secondary|Best Overall Response (BOR) by Independent Central Review (Phase II Treatment Period)|BOR was planned to be determine according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and as adjudicated by an Independent Central Review. BOR is defined as the best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression or recurrence (taking the smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 millimeter (mm). PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from baseline or appearance of 1 or more new lesions.|From first dose of study drug administration until PD or death, assessed up to 12 months|As the study was terminated early following the discontinuation of the TH-302 clinical development program, it was decided as per Statistical Analysis Plan not to collect and evaluate the efficacy data for this study||||||
2592596|NCT02255110|Secondary|Progression-free Survival (PFS) (Phase II Treatment Period)|PFS was planned to assess as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Progressive Disease (PD) is defined as at least a 20 percent (%) increase in the Sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.|From first dose of study drug administration until PD or death, assessed up to 12 months|As the study was terminated early following the discontinuation of the TH-302 clinical development program, it was decided as per Statistical Analysis Plan not to collect and evaluate the efficacy data for this study||||||
2592597|NCT02255110|Secondary|Progression-free Survival (PFS) by Investigator and Independent Central Review (Phase II Treatment Period)|PFS was planned to assess as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Progressive Disease (PD) is defined as at least a 20 percent (%) increase in the Sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.|From first dose of study drug administration until PD or death, evaluated at 3 months and 9 months|As the study was terminated early following the discontinuation of the TH-302 clinical development program, it was decided as per Statistical Analysis Plan not to collect and evaluate the efficacy data for this study||||||
2592598|NCT02255110|Secondary|Progression Free Survival (PFS) by Investigator Review (Phase II Treatment Period)|PFS was planned to assess as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Progressive Disease (PD) is defined as at least a 20 percent (%) increase in the Sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.|From first dose of study drug administration until PD or death, evaluated at 6 months|As the study was terminated early following the discontinuation of the TH-302 clinical development program, it was decided as per Statistical Analysis Plan not to collect and evaluate the efficacy data for this study||||||
2592599|NCT02255110|Primary|Progression Free Survival (PFS) by Independent Central Review (Phase II Treatment Period)|PFS was planned to assess as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Progressive Disease is defined as at least a 20 percent (%) increase in the Sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.|From first dose of study drug administration until PD or death, evaluated at 6 months|As the study was terminated early following the discontinuation of the TH-302 clinical development program, it was decided as per Statistical Analysis Plan not to collect and evaluate the efficacy data for this study||||||
2594352|NCT02233738|Secondary|Brief Symptom Inventory(BSI-18) at 1 Month|Min value:0 Max value:72 Higher score indicates higher psychological distress|1 month||||score on a scale||Standard Deviation|Mean
2592600|NCT02255097|Secondary|OS in Strong PD-L1-Positive Participants|Participants with a strong PD L-1 expression status were evaluated for OS. The expression of PD L-1 was determined by IHC and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50% by IHC. OS was defined as the time from the first day of study treatment to death due to any cause. OS was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥50%|||Months||95% Confidence Interval|Median
2592601|NCT02255097|Secondary|OS in PD-L1-Positive Participants|Participants with a positive PD L-1 expression status were evaluated for OS. The expression of PD L-1 was determined by IHC and PD-L1 positive was defined as a PD-L1 tumor proportion score ≥1% by IHC. OS was defined as the time from the first day of study treatment to death due to any cause. OS was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥1%|||Months||95% Confidence Interval|Median
2592602|NCT02255097|Secondary|Overall Survival (OS) in All Participants|OS was defined as the time from the first day of study treatment to death due to any cause. OS was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication|||Months||95% Confidence Interval|Median
2592603|NCT02255097|Secondary|PFS in Strong PD-L1-Positive Participants|Participants with a strong PD L-1 expression status were evaluated for PFS by modified RECIST 1.1. The expression of PD L-1 was determined by IHC and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50% by IHC. PFS was defined as the time from the first day of study treatment to the first documented PD per RECIST 1.1 or death due to any cause, whichever occurred first. Using RECIST 1.1, PD was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm the sum of lesions, OR the appearance of new lesions. PFS was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥50%|||Months||95% Confidence Interval|Median
2592604|NCT02255097|Secondary|PFS in PD-L1-Positive Participants|Participants with a positive PD L-1 expression status were evaluated for PFS. The expression of PD L-1 was determined by IHC and PD-L1 positive was defined as a PD-L1 tumor proportion score ≥1% by IHC. PFS was defined as the time from the first day of study treatment to the first documented PD per RECIST 1.1 or death due to any cause, whichever occurred first. Using RECIST 1.1, PD was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm the sum of lesions, OR the appearance of new lesions. PFS was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥1%|||Months||95% Confidence Interval|Median
2592605|NCT02255097|Secondary|Progression-free Survival (PFS) in All Participants|PFS was defined as the time from the first day of study treatment to the first documented PD per RECIST 1.1 or death due to any cause, whichever occurred first. Using RECIST 1.1, PD was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm the sum of lesions, OR the appearance of new lesions. PFS was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication|||Months||95% Confidence Interval|Median
2592606|NCT02255097|Secondary|DOR in Strong PD-L1-Positive Participants|Participants with a strong PD L-1 expression status were evaluated for DOR based n RECIST 1.1. The expression of PD L-1 was determined by IHC and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50% by IHC. DOR was measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥50% and a best overall response as confirmed complete response or partial response|||Months||Full Range|Median
2592607|NCT02255097|Secondary|DOR in PD-L1-Positive Participants|Participants with a positive PD L-1 expression status were evaluated for DOR based on RECIST 1.1. The expression of PD L-1 was determined by IHC and PD-L1 positive was defined as a PD-L1 tumor proportion score ≥1% by IHC. DOR was measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥1% and a best overall response as confirmed complete response or partial response|||Months||Full Range|Median
2592608|NCT02255097|Secondary|Response Duration (DOR) in All Participants|DOR was based on RECIST 1.1 and measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or PD was objectively documented (taking as reference for PD the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed by the Kaplan-Meier method for censored data and reported in months.|Up to 3 years|All participants who received at least one dose of study medication with a best overall response as confirmed complete response or partial response|||Months||Full Range|Median
2592696|NCT02253654|Secondary|Number of RBC Units Transfused Overall and During Each Study Period|The number of red blood cell (RBC) units transfused during the study and during each study period.|Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41|Primary analysis set with available data in each study period|||participants|||Number
2592609|NCT02255097|Secondary|ORR by Modified RECIST Version 1.1 in Strong PD-L1-Positive Participants|Participants with a strong PD L-1 expression status were evaluated for ORR by modified RECIST 1.1. The expression of PD L-1 was determined by IHC and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50% by IHC. ORR was assessed by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. If imaging shows disease progression (PD) imaging was repeated 4 weeks later to confirm progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions and new measurable lesions, taking as reference the smallest sum recorded since treatment started.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥50%|||Percentage of participants||95% Confidence Interval|Number
2592610|NCT02255097|Secondary|ORR by Modified RECIST Version 1.1 in PD-L1-Positive Participants|Participants with a positive PD L-1 expression status were evaluated for ORR by modified RECIST 1.1. The expression of PD L-1 was determined by IHC and PD-L1 positive was defined as a PD-L1 tumor proportion score ≥1% by IHC. ORR was assessed by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. If imaging shows disease progression (PD) imaging was repeated 4 weeks later to confirm progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions and new measurable lesions, taking as reference the smallest sum recorded since treatment started.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥1%|||Percentage of participants||95% Confidence Interval|Number
2592611|NCT02255097|Secondary|ORR by Modified RECIST Version 1.1 in All Participants|ORR was assessed by modified RECIST 1.1 by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference. If imaging shows disease progression (PD) imaging was repeated 4 weeks later to confirm progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions and new measurable lesions, taking as reference the smallest sum recorded since treatment started.|Up to 3 years|All participants who received at least one dose of study medication|||Percentage of participants||95% Confidence Interval|Number
2592612|NCT02255097|Secondary|ORR by RECIST Version 1.1 in Human Papilloma Virus (HPV)-Positive Tumors|Participants with a HPV-positive tumor biopsy were evaluated for ORR by RECIST 1.1. ORR was assessed by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference.|Up to 3 years|All participants who received at least one dose of study medication with a HPV-positive tumor|||Percentage of participants||95% Confidence Interval|Number
2592613|NCT02255097|Secondary|ORR by RECIST 1.1 in PD-L1-Positive Participants|Participants with a positive PD L-1 expression status were evaluated for ORR by RECIST 1.1. The expression of PD L-1 was determined by IHC and PD-L1 positive was defined as a PD-L1 tumor proportion score ≥1% by IHC. ORR was assessed by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥1%|||Percentage of participants||95% Confidence Interval|Number
2592614|NCT02255097|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.|From first dose to last dose of treatment; up to 25 months|"All participants who received at least one dose of study medication~."|||Participants|||Number
2592615|NCT02255097|Primary|Number of Participants Experiencing an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.|From first dose to last dose of treatment plus 2 months of follow-up, up to 27 months|All participants who received at least one dose of study medication|||Participants|||Number
2592697|NCT02253654|Secondary|Weekly Epoetin Alfa Dose at Each Visit||Weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35|Primary analysis set with available data at each time point|||units||Standard Deviation|Mean
2592616|NCT02255097|Primary|ORR by RECIST Version 1.1 in Strong Programmed Cell Death Ligand 1 (PD-L1)-Positive Participants|Participants with a strong PD L-1 expression status were evaluated for ORR by RECIST 1.1. The expression of PD L-1 was determined by immunohistochemistry (IHC) and strong PD-L1 positive was defined as a PD-L1 tumor proportion score ≥50% by IHC. ORR was assessed by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a CR defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or PR defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference.|Up to 3 years|All participants who received at least one dose of study medication with a Tumor Proportion Score ≥50%|||Percentage of participants||95% Confidence Interval|Number
2592617|NCT02255097|Primary|Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants|ORR was assessed by RECIST 1.1 by performing study imaging every 6-9 weeks after the first dose of study treatment. ORR was defined as the proportion of participants in the analysis population who had a Complete Response (CR) defined as a disappearance of all target lesions with pathological lymph nodes having a reduction in short axis to <10 mm) or Partial Response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as a reference.|Up to 3 years|All participants who received at least one dose of study medication|||Percentage of participants||95% Confidence Interval|Number
2592618|NCT02254772|Secondary|Median Time to Progression (TTP)|Tumor progression was assessed as any new lesion or increase by ≥ 50% of any previously-involved site after treatment nadir.|Up to 2 years|1 participant had stable disease, but did not provide a final follow-up at 2 years.|||Months||Full Range|Median
2592619|NCT02254772|Secondary|Tumor Response|"Tumor response was assessed per the Cheson Criteria for low-grade B-cell lymphomas.~Complete Response (CR) - No evidence disease. Partial Response (PR) - Regression of measurable disease with no new sites Progressive Disease (PD) - Any new lesion or increase by ≥ 50% of any previously-involved site after treatment nadir.~Stable Disease (SD) - Any status that is not CR; PR; or PD. See references (Cheson BD, et al. J Clin Oncol. Apr 1999;17(4):1244. PubMed ID 10561185."|Up to 2 years|Note that 1 participants initially experienced a partial response (PR), but later had progressive disease (PD).|||Participants|||Count of Participants
2592620|NCT02254772|Primary|Number of Dose-limiting Toxicity (DLT) Events of Ipilimumab Plus a Fixed Dose of SD-101 (1 mg/Week)|"To determine the safety and tolerability of SD-101 (1 mg/week) and local low dose radiation plus escalating doses of subcutaneously (SC)-administered ipilimumab, the incidence of dose-limiting toxicities (DLT) will be assessed according to the following DLT definitions. Related adverse events (AEs) are toxicities. Treatment includes radiation therapy.~Grade 4 treatment-related AE~Any drug-related AE ≥ Grade 3, including injection site reaction~≥ Grade 3 treatment-related clinical autoimmune reaction involving major organs (defined as liver, pancreas, lung, heart, kidney, bowel, bone marrow, eye, or central nervous system) which does not resolve to baseline or Grade 1 within 6 weeks~Treatment-related AE ≥ Grade 3 that persists despite adequate/maximal medical therapy and/or prophylaxis, EXCEPT~Treatment-related skin rash ≤ Grade 3, that does not require systemic steroid therapy or other immunosuppressive therapy OR~Grade 3 flu-like AEs~Uveitis ≥ Grade 2"|Up to 10 weeks|Only the starting dose level of 10 mg ipilimumab plus SD-101 (1 mg/week) was evaluated. The dose level of ipilimumab could not be escalated due to inability to obtain a higher concentration of ipilimumab.|||Dose-limiting toxicity events|||Number
2592621|NCT02254681|Secondary|Number of Participants With Intrahepatic Disease Progression After Treatment With Combination Low-dose Radiotherapy and Gemcitabine-cisplatin.|To determine the number of participants with Intrahepatic disease progression assessed by MRI of the abdomen with intravenous gadolinium contrast using RECIST criteria.|From date of first treatment until date of first documented progression or date of death from any cause, which ever comes first, assessed up to 24 months.||||Participants|||Count of Participants
2592622|NCT02254681|Secondary|Number of Participants With Intrahepatic Recurrence After Partial Hepatectomy With Antecedent Combination Low-dose Radiotherapy and Gemcitabine-cisplatin.|To determine the number of participants with Intrahepatic recurrence assessed by RECIST criteria using MRI of the abdomen with intravenous gadolinium contrast.|From date of partial hepatectomy until date of first documented recurrence or date of death from any cause, assessed up to 24 months.|Only 1 of the 6 subjects had surgery to assess recurrence after hepatectomy.|||Participants|||Count of Participants
2592623|NCT02254681|Secondary|Number of Participants With Injury to the Background Liver After Combination Low-dose Radiotherapy and Gemcitabine-cisplatin.|Background (non-tumor bearing) liver tissue will be obtained by either biopsy or liver resection after combination chemoradiotherapy. Histologic markers of Radiation Induced Liver disease will be measured.|16 weeks after start of first treatment.|data not collected||||||
2592624|NCT02254681|Secondary|Number of Participants With Histologic Disease Response After Combination Low-dose Radiotherapy and Gemcitabine-cisplatin.|Tumor tissue will be obtained by either biopsy or liver resection after combination chemoradiotherapy. Histologic response will be determined by extent of viable tumor, tumor necrosis, and surrounding fibrosis.|16 weeks after start of first treatment|data not collected||||||
2592625|NCT02254681|Secondary|Number of Participants With Post-operative Complications After Partial Hepatectomy After Antecedent Combination Low-dose Radiotherapy and Gemcitabine-cisplatin.|Measured post-operative complications include (but not limited to) bile leak, liver failure, ascites, infection, any organ failure or insufficiency, venous thromboembolism, and mortality.|up to 90 days after partial hepatectomy|1 of 6 subjects had surgery therefore only 1 subject was analyzed for post-operative complications.|||Participants|||Count of Participants
2592626|NCT02254681|Primary|Number of Participants With Adverse Events.|Number of participants with adverse events during combined low-dose radiotherapy and gemcitabine-cisplatin treatment.|up to 16 weeks after treatment start||||Participants|||Count of Participants
2592690|NCT02254265|Primary|Global Symptom Score|"Mean change from baseline at day 84 for the global symptom score.~The freuency and severy of dry eye and irritation scores were used to calculate symptom score as follows:~Frequency of dry eye/irritation based on a scale of 0 (rarely) to 100 (all the time) Severity of dryness or irritation based on a scale of 0 (very mildly) to 100 (very severe).~The global symptom score was calculated as the square root of the frequency score times the severity score"|Baseline to 84 days|Intent to treat population, observed data|||score on a scale||Standard Deviation|Mean
2592627|NCT02254681|Primary|Number of Participants With Radiographic Disease Response After Combination Low-dose Radiotherapy and Gemcitabine-cisplatin.|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|16 weeks after treatment start|decision was made to close the study due to the futility of the regimen in the first 6 subjects, as well as the lack of funding to complete the study.|||Participants|||Count of Participants
2592628|NCT02254551|Secondary|Overall Response|Number of patients with confirmed Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Progressive Disease (PD) or Stable Disease (SD) according to International Myeloma Working Group (IMWG) Uniform Response Criteria. CR=5% or less plasma cells in bone marrow, disappearance of soft tissue plasmacytoma, negative immunofixation on serum and urine. VGPR=Serum and urine M-protein detectable by immunofixation but not by electrophoresis, disappearance of any soft tissue plasmacytomas that were present at baseline. PR= at least 50% reduction from baseline in serum M-protein and at least 90% reduction from baseline in 24hr urinary M-protein. PD=Increase of 25% or more from nadir in serum or urine proteins. SD= not meeting criteria for CR, VGPR, PR or PD.|Every 3 weeks up to 48 weeks|Of 7 enrolled patients, 1 was deemed ineligible and was excluded from efficacy analyses. At a median follow-up of 6 weeks, 3 patients in Cohort 1 had progressive disease and 3 had stable disease. Study was terminated after reviewing data from this first lead-in cohort.|||Participants|||Count of Participants
2592629|NCT02254551|Primary|Time to Disease Progression|Time to progression (TTP) is measured from Day 1 of study drug administration to disease progression using International Myeloma Working Group (IMWG) Uniform Response Criteria.|every 3 weeks up to 48 weeks, then every 3 months thereafter up to 3 years from initiation of study treatment.|This outcome measure was to be assessed during the expansion phase of the study. The study closed early and did not proceed to this phase of the study. There is no data to report for this outcome measure.||||||
2592630|NCT02254551|Primary|Maximum Tolerated Dose (MTD) of LDE225 Plus Bortezomib|During the safety lead-in, a standard 3+3 dose escalation design was used to establish the MTD for LDE225 in combination with bortezomib. The MTD would be determined by the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) during one cycle (21 days) of therapy. If 2 of 6 patients within a dose level experienced a DLT, that dose level would be defined as exceeding MTD and no further dose escalation would occur. The previous dose level would be considered the MTD.|every 3 weeks up to 48 weeks|||||||Number
2592631|NCT02254486|Secondary|Polyp Detection Rate (Overall Colon)|Comparison of the number of patients with at least one polyp detected in the overall colon when NER1006 is used for bowel cleansing versus Trisulfate Solution. PDR defined as the number of patients with at least one polyp in the overall colon.|Two days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
2592632|NCT02254486|Secondary|Polyp Detection Rate (Colon Ascendens)|Comparison of the number of patients with at least one polyp detected in the colon ascendens when NER1006 is used for bowel cleansing versus Trisulfate Solution. Polyp detection rate (PDR) defined as the number of patients with at least one polyp in the colon ascendens.|Two days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
2592633|NCT02254486|Secondary|Adenoma Detection Rate (Overall Colon)|Comparison of the number of patients with at least one adenoma detected in the overall colon when NER1006 is used for bowel cleansing versus Trisulfate Solution. ADR defined as the number of patients with at least one adenoma in the overall colon.|Two days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
2592634|NCT02254486|Secondary|Adenoma Detection Rate (Colon Ascendens)|Comparison of the number of patients with at least one adenoma detected in the colon ascendens when NER1006 is used for bowel cleansing versus Trisulfate Solution. Adenoma detection rate (ADR) defined as the number of patients with at least one adenoma in the colon ascendens.|Two days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug|||Participants|||Count of Participants
2592635|NCT02254486|Primary|Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)|The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). Highly effective cleansing in the colon ascendens corresponded to scores 3 (Good) or 4 (Excellent) of the HCS. Adequate plus failure of cleansing corresponded to score 0-2. Comparison of 'Excellent plus good' cleansing of the colon ascendens using NER1006 versus Trisulfate Solution was evaluated using a non-inferiority study design.|Two days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
2592691|NCT02254265|Primary|Conjunctival Staining|"Mean change from baseline at day 84 for the lissamine green conjunctival staining score in the designated study eye.~The Investigator recorded a score for each area of each eye on a 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots) scale"|Baseline to 84 days|Intent to treat population, last observed carried forward approach|||score on a scale||Standard Deviation|Mean
2592636|NCT02254486|Primary|Number of Patients With Successful Bowel Cleansing (Overall Colon)|The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e., all mucosa could be visualised) and C and D are classified as unsuccessful. Comparison of overall success of cleansing with NER1006 versus Trisulfate solution was evaluated using a non-inferiority study design.|Two days (from day of first dosing to day of colonoscopy)|The overall number of participants analyzed was based on the mFAS. This included all randomized patients, except any patient who (i) was randomized but subsequently failed to meet entry criteria and (ii) in whom it was confirmed (from their patient diary) that the same patient did not receive any study drug.|||Participants|||Count of Participants
2592637|NCT02254473|Secondary|Kellgren and Lawrence Classification of Osteoarthritis of Knee|X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee).|6 months|Data was not gathered due to pre-mature termination of the study.||||||
2592638|NCT02254473|Secondary|Kellgren and Lawrence Classification of Osteoarthritis of Knee|X-Ray used to measure Kellgren and Lawrence Classification of Osteoarthritis of Knee (joint space in the knee).|Baseline|Data was not gathered due to pre-mature termination of the study.||||||
2592639|NCT02254473|Primary|Patient Reported Function and Pain|Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.|12 months||||score on a scale 0-10 (normal)||Full Range|Mean
2592640|NCT02254473|Primary|Patient Reported Function and Pain|Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.|9 months||||score on a scale 0-10 (normal)||Full Range|Mean
2592641|NCT02254473|Primary|Patient Reported Function and Pain|Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.|6 months||||score on a scale 0-10 (normal)||Full Range|Mean
2592642|NCT02254473|Primary|Patient Reported Function and Pain|Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.|3 months||||score on a scale 0-10 (normal)||Full Range|Mean
2592643|NCT02254473|Primary|Patient Reported Function and Pain|Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.|6 weeks||||score on a scale 0-10 (normal)||Full Range|Mean
2592644|NCT02254473|Primary|Patient Reported Function and Pain|Tegner: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The scale is 0 to 10 where 10 corresponds to normal function and 0 to unable to perform.|Baseline||||score on a scale 0-10 (normal)||Full Range|Mean
2592645|NCT02254460|Primary|Fractional Iron Absorption|Iron uptake was measured using stable isotopes of 57Fe and 58Fe to label the test and control products. Fractional iron absorption levels of 57Fe and 58Fe were calculated, to give a direct measure of the iron uptake from each of the study treatments.|Day 15|Per protocol (PP) population, defined as all participants who received at least one study treatment administration and who did not have any protocol violations deemed to affect evaluation of the iron absorption. This analysis was conducted on PP population.|||% Iron Absorbed||Standard Deviation|Mean
2592646|NCT02254421|Secondary|Percentage of All-Cause Mortality Among Participants Through Day 28||Up to Day 28|Full Analysis Set: all randomized participants who received at least 1 full dose of study drug and had an RSV viral load greater than or equal to the lower limit of quantification of the RT-qPCR assay in the Day 1 nasal sample, as determined by RT-qPCR at the central lab.|||percentage of participants||95% Confidence Interval|Number
2592647|NCT02254421|Secondary|Percentage of Participants Developing Respiratory Failure Requiring Mechanical Ventilation Through Day 28||Up to Day 28|Full Analysis Set: all randomized participants who received at least 1 full dose of study drug and had an RSV viral load greater than or equal to the lower limit of quantification of the RT-qPCR assay in the Day 1 nasal sample, as determined by RT-qPCR at the central lab.|||percentage of participants||95% Confidence Interval|Number
2592648|NCT02254421|Secondary|Number of Supplemental O2-Free Days Through Day 28||Up to Day 28|Full Analysis Set: all randomized participants who received at least 1 full dose of study drug and had an RSV viral load greater than or equal to the lower limit of quantification of the RT-qPCR assay in the Day 1 nasal sample, as determined by RT-qPCR at the central lab.|||days||Inter-Quartile Range|Median
2592649|NCT02254421|Primary|Time-weighted Average Change in Nasal Respiratory Syncytial Viral (RSV) Load From Baseline to Day 9|The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factors.|Baseline to Day 9|Full Analysis Set: all randomized participants who received at least 1 full dose of study drug and had an RSV viral load greater than or equal to the lower limit of quantification of the RT-qPCR assay in the Day 1 nasal sample, as determined by RT-qPCR at the central lab.|||log10 copies/mL||Standard Error|Mean
2592650|NCT02254408|Secondary|Percentage of Participants Who Developed Respiratory Failure (of Any Cause) Requiring Mechanical Ventilation (Invasive or Noninvasive) or All-cause Mortality|"Participants were considered to have an event if either condition is met:~Participant develops a respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) or;~Participant dies prior to or on Day 28"|Up to Day 28|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2592651|NCT02254408|Primary|Percentage of Participants Who Developed a Lower Respiratory Tract Complication|"A Lower Respiratory Tract Complication (LRTC) was defined as one of the below as determined by the adjudication committee:~Primary RSV lower respiratory tract infection (LRTI)~Secondary bacterial LRTI~LRTI due to unusual pathogens~Lower respiratory tract complication of unknown etiology"|Up to Day 28|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2592692|NCT02254252|Secondary|Side-effects|Patients were asked and underwent physical examination regarding the common and uncommon side effects attributed to anti-angina medications|1 month|||||||
2592652|NCT02254408|Primary|Time-Weighted Average Change in Nasal Respiratory Syncytial Virus (RSV ) Viral Load From Baseline (Day 1) to Day 9|The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.|Baseline; Day 9|Full Analysis Set: participants who received at least 1 full dose of study drug and had an RSV viral load greater than or equal to the lower limit of quantification of the quantitative real-time polymerase chain reaction (RT-qPCR) assay in the Day 1 nasal sample, as determined by RT-qPCR.|||log10 copies/mL||Standard Deviation|Mean
2592653|NCT02254304|Secondary|Body Mass Index (BMI)|BMI was defined as weight in kilogram (kg) divided by height in square meter (m^2).|Baseline, Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||Kg/m^2||Standard Deviation|Mean
2592654|NCT02254304|Secondary|Expanded Disability Status Scale (EDSS) Score|EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS).|Baseline, Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||Units on a scale||Standard Deviation|Mean
2592655|NCT02254304|Secondary|Number of Subjects With Adverse Event or Adverse Drug Reaction (AE/ADR), Serious AE/ADR, AE/ADR Leading to Death and AE/ADR Leading to Early Termination|An AE was any untoward medical occurrence in a subject or clinical investigation in a subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An ADR was any unfavourable or unintended response (adverse event) that could possibly be related to drug treatment. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. AE/ADR was planned to be reported for both the arms together.|Baseline up to 12 months|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||subjects|||Number
2592656|NCT02254304|Secondary|Number of Subjects With Medication Adherence Based on Morisky Medication Adherence Score|The Morisky Medication Adherence Scale (MMAS) is a valid and reliable instrument that consists of 8 items that measure medication adherence. The scores of the MMAS-8 range from 0 to 8. This self-report scale consists of 7 items answered with a yes or no and 1 item with a 5-point Likert scale. A score below 6 indicates low adherence, a score between 6 to < 8 indicates medium adherence and a score of 8 indicates high adherence.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||subjects|||Number
2592657|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Subjects With Percentage of Work Completed Despite of Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Amount of work done by subjects in spite of multiple sclerosis was presented under different percentages (0-100%)|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||Subjects|||Number
2592658|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Subjects Accomplished Less Work Due to Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects accomplished less work due to MS were presented.|Month 12|"Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects evaluable for this outcome measure."|||subjects|||Number
2592659|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Missed From Work by Subjects|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of hours per day missed from work by subjects were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||hours per day||Standard Deviation|Mean
2592660|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Partial Days From Work Due to Multiple Sclerosis (MS).|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects who missed any partial days from work due to MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||subjects|||Number
2592693|NCT02254252|Primary|Canadian Cardiovascular Society (CCS) Grading of Angina Pectoris|One month after treatment, patients were asked to describe the angina episode and based on their descriptions, the CCS class of chest pain was determined. Based on patient's description of the anginal episodes, angina severity was classified into one of CCS class I (angina only with prolonged demanding physical activity), Class II (Slight limitation, with angina only during vigorous physical activity), Class III (Symptoms with everyday living activities), or class IV (angina at rest).|1 month||||participants|||Number
2592661|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Full Days Missed From Work by Subjects|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of full days missed from work by subjects were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||days||Standard Deviation|Mean
2592662|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Subjects Who Missed Any Full Days From Work Due to Multiple Sclerosis (MS).|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects who missed any full days from work due to MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||subjects|||Number
2592663|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Working Days Missed by Relative or Friend Due to Subjects' Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of working days missed by relative or friend due to subjects' MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||days||Standard Deviation|Mean
2592664|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Subjects Whose Relatives or Friends Missed Work Due to Subjects' Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects whose relatives or friends missed work due to subjects' MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||subject|||Number
2592665|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Hours Per Day Assistant Worked for Subject Due to Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of hours per week assistant worked for subject due to MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||hours per day||Standard Deviation|Mean
2592666|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Days Per Week Assistant Worked For Subject Due to Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of days per week assistant worked for subject due to MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||days per week||Standard Deviation|Mean
2592667|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire -Number of Subjects Who Paid Someone to Assist Them Due to Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of subjects who paid someone to assist them due to MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||subjects|||Number
2592668|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Days Subjects Hospitalized Due to Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of days subjects hospitalized due to MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||days||Standard Deviation|Mean
2592763|NCT02253160|Secondary|MNC Blood Product Volume (mL)|The produced unit of MNCs collected into the blood bag.|within 5 minutes upon completion of procedure||||mL||Standard Deviation|Mean
2592669|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Times Subjects Visited Emergency Room Due to Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of times subjects visited emergency room due to MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants analyzed” signifies number of subjects evaluable for this outcome measure.|||emergency room visits||Standard Deviation|Mean
2592670|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Visits by Healthcare Professional to Subjects' Home|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of visits by healthcare professional to subjects' home were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects evaluable for this outcome measure.|||visits||Standard Deviation|Mean
2592671|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Subjects Visiting Different Types of Doctors During Their Clinical Visit|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Subjects who took consultations with specialists, general practitioners for MS were presented.|Month 12|"Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here Number of Participants Analyzed signifies number of subjects who visited to doctors for MS."|||subjects|||Number
2592672|NCT02254304|Secondary|Healthcare Resource Utilization Questionnaire - Number of Visits to Clinic by Subjects Due to Multiple Sclerosis (MS)|Subjects was assessed at Month 12 utilizing the Health Resource Utilization Questionnaire (HRUQ), a subject self-report tool designed to evaluate the economic impact of MS. Healthcare resource utilization was collected in the following areas: admissions and stays in the hospital, emergency room, consultations with specialists, general practitioners, or other healthcare professionals, work productivity, health care financial impact. Number of visits to clinic by subjects due to MS were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects who visited clinic for MS.|||visits||Standard Deviation|Mean
2592673|NCT02254304|Secondary|Overall Evaluation of RebiSmart Use as Assessed by Investigator|Evaluation of RebiSmart was categorized under very easy, quite easy, Neither easy nor difficult, very difficult and missing|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||subjects|||Number
2592674|NCT02254304|Secondary|Number of Subjects With Reasons of Missed Injections|Number of subjects with the reasons of missed injections were presented. Aspartate transaminase and alanine transaminase are abbreviated as ALT and AST respectively. Glutamic oxaloacetic transaminase and glutamic pyruvic transaminase are abbreviated as GOT and GPT respectively.|Baseline up to 12 months|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment. Here “Number of Participants Analyzed” signifies number of subjects who missed the injections are evaluable for this outcome measure.|||subjects|||Number
2592675|NCT02254304|Secondary|Mean Number of Relapses in RMS Subjects|A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||relapses||Standard Deviation|Mean
2592676|NCT02254304|Secondary|Percentage of Subjects Free From Disability Progression|Expanded Disability Status Scale is abbreviated as EDSS.|Baseline up to 12 months|Data could not be analyzed for this outcome because this EDSS progression requires EDSS to be collected every 3/6 months and confirmed 3/6 months later. Since EDSS progression was only done at Month 12, therefore this derived outcome could not be estimated.||||||
2592677|NCT02254304|Secondary|Percentage of Subjects Free From Clinical Disease Activity|Expanded Disability Status Scale is abbreviated as EDSS.|Baseline up to 12 months|Data could not be analyzed for this outcome because this is a composite outcome dependent on subjects free from relapses and EDSS progression, where EDSS progression requires to be collected every 3/6 months and confirmed 3/6 months later. Since EDSS progression was only done at Month 12, therefore this derived outcome could not be estimated.||||||
2592678|NCT02254304|Secondary|Percentage of Subjects Who Prematurely Terminated Treatment and Reasons|Percentage of subjects who prematurely terminated treatment and reasons were presented.|Baseline up to 12 months|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||percentage of subjects|||Number
2592694|NCT02254252|Primary|Angina Episode Intensity|One month after treatment, patients were asked to determine the average intensity of chest pain in experienced episodes using a Likert-type scale of 0 to 10, where 0 indicated lowest intensity/no pain and 10 indicated the highest possible pain experienced.|1 month||||units on a scale||Standard Deviation|Mean
2592695|NCT02254252|Primary|Angina Episode Frequnecy|One month after treatment, patients were asked to determine the frequency of angina episodes in the preceding week.|1 month||||episodes per week||Standard Deviation|Mean
2592960|NCT02251912|Primary|Proportion of Heavy Drinking Days|Mean proportion of days per week, over the 12-week trial, when subjects drank heavily (5 or more standard drinks for men, 4 or more standard drinks for women).|12 weeks||||proportion of days per week||Standard Error|Least Squares Mean
2592679|NCT02254304|Secondary|Percentage of Subjects With Relapse by Adherence Category|A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. According to the World Health Organisation (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term). Percentage of subjects with relapses by adherence categories (<=50%, >50-75%, >75-90%, >90%) were presented. Adherence missing are the subjects who withdrew before 12 months and who did not have any relapses before withdrawal.|Month 12|"Full analysis set was used. Here Number analyzed signifies those subjects who were evaluable for specified categories. There were no subjects analyzed for certain categories (that is, “Number analyzed”= 0) because no subjects were evaluable for that arm in the specified category."|||percentage of subjects|||Number
2592680|NCT02254304|Secondary|Percentage of Subjects With Treatment Adherence|According to the World Health Organisation (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term). Percentage of subjects with treatment adherence under different categories (<=50%, >50-75%, >75-90%, >90%) were presented.|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||percentage of subjects|||Number
2592681|NCT02254304|Primary|Time to the First Relapse for CIS Subjects|"A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to MS, accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. Time to the first relapse was defined as the duration from start of the treatment until first relapse. Data was planned to be reported for Rebif in CIS Subjects arm."|Baseline up to 12 months|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||months||Inter-Quartile Range|Median
2592682|NCT02254304|Primary|Percentage of Relapse-free RMS Subjects|"A relapse was defined as the appearance of a new symptom or worsening of an old symptom, attributable to multiple sclerosis (MS), accompanied by an appropriate new neurological abnormality or focal neurological dysfunction lasting at least 24 hours in the absence of fever, and preceded by stability or improvement for at least 30 days. Relapse-free RMS subjects were those who did not had relapse during 12 month treatment period. Data was planned to be reported for Rebif in RMS Subjects arm."|Month 12|Full analysis set included all subjects enrolled into the study and who received at least one dose of study treatment.|||percentage of subjects|||Number
2592683|NCT02254291|Secondary|Change in Glycosylated Haemoglobin A1c (HbA1c)|"Mean changes in HbA1c values from baseline after 30 weeks of treatment. Changes in HbA1c were analysed using a mixed model for repeated measurements (MMRM) with treatment and pre-trial treatment at screening as fixed factors and baseline value as covariate. The data were analysed for the on-treatment without rescue medication observation period which includes observations noted at or after the date of first dose of randomised treatment and not after the last dose of the trial product (+ a 7-day visit window) or initiation of rescue medication."|Week 0 and week 30|The full analysis set (FAS) included all randomised subjects who have received at least one dose of trial product. All subjects contributed to the statistical model of the data analysis, but not all subjects had a value at week 30.|||Percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
2592684|NCT02254291|Secondary|Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes|Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia was an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The episodes mentioned here are treatment emergent hypoglycaemic episodes and defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).|Weeks 0-30|The safety analysis set (SAS) included all subjects receiving at least one dose of trial product and subjects contributed to the evaluation “as treated”.|||Number of episodes|||Number
2592685|NCT02254291|Primary|Number of Treatment Emergent Adverse Events (TEAEs)|An adverse events (AEs) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-30 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).|Weeks 0-30|The safety analysis set (SAS) included all subjects receiving at least one dose of trial product and subjects contributed to the evaluation “as treated”.|||Number of events|||Number
2592686|NCT02254265|Secondary|Patient Satisfaction|Patient satisfaction with treatment score using 5-point scale (1=extremely dissatisfied to 5=extremely satisfied)|Baseline to 84 days|Intent to treat population (Observed)|||score on a scale||Standard Deviation|Mean
2592687|NCT02254265|Secondary|Schirmer's Test|"Change from Baseline in Categorized Schirmer's Test Score. Schirmer's test was performed with strips placed in both eyes at the same time. Strips were removed after 5 minutes and the amount of wetting (in mm) was recorded as scores from 1 to 5.~1: < 3 mm, 3 - 6 mm, 7 - 10 mm, 11 - 14 mm, and 5: > 14 mm"|Baseline to 84 days|Intent to treat population (with both eyes averaged)|||score on a scale||Standard Deviation|Mean
2592688|NCT02254265|Secondary|Corneal Staining Score|Mean Change from Baseline in Corneal Staining Score in the Study Eye. Expanded National Eye Institute Scale for Corneal Staining Score was used to grade each of the 5 areas of the cornea on a 0 (No punctate stain in area) to 4 (Severe diffuse (coalescent) macropunctate stain of the area) scale|Baseline to 84 days|Intent to treat population, Last observed carried forward approach|||score on a scale||Standard Deviation|Mean
2592689|NCT02254265|Secondary|Tear Film Break up Time (TBUT)|Mean change from baseline in TBUT in the study eye from baseline at Day 84|Baseline to 84 days|Intent to treat population - observed data|||seconds||Standard Deviation|Mean
2592698|NCT02253654|Secondary|Percentage of Participants With Hemoglobin Excursions at Each Visit|An excursion is identified as an event when a hemoglobin concentration fell below or exceeded the pre-specified thresholds of: - < 9.0 g/dL, or - > 11.0 g/dL, or - > 12.0 g/dL. The percentage of participants with any excursions and excursions in each subcategory at each time point and overall during the study are reported.|Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37|Primary analysis set with available data at each time point|||percentage of participants|||Number
2592699|NCT02253654|Secondary|Hemoglobin Intra-subject Variability|Intra-subject variability was defined for each participant as the standard deviation (SD) of all of the hemoglobin concentrations during the evaluation period for the participant. The mean intra-subject SD for all participants is the sum of the intra-subject SDs divided by the total number of participants evaluated.|The evaluation period (weeks 13 to 37)|Primary analysis set|||g/dL||Standard Deviation|Mean
2592700|NCT02253654|Secondary|Hemoglobin Rate of Change at Each Visit|Hemoglobin rate of change (ROC) was calculated for each visit using the following formula: ROC = (current visit hemoglobin value - previous visit hemoglobin value) / number of days between each visit * 14. A positive value indicates a rate of rise and a negative value indicates a rate of decline.|Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37|Primary analysis set with available data at each time point|||g/dL/2 weeks||Standard Deviation|Mean
2592701|NCT02253654|Secondary|Percentage of Participants With Transfusion Events Overall and During Each Study Period|The percentage of participants who received red blood cell (RBC) transfusions during the study and during each study period.|Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41|Primary analysis set with available data in each study period|||percentage of participants|||Number
2592702|NCT02253654|Secondary|Hemoglobin Concentration at Each Visit||Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37|Primary analysis set with available data at each time point|||g/dL||Standard Deviation|Mean
2592703|NCT02253654|Primary|Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period|Hemoglobin was measured every 2 weeks during the evaluation period. The percentage of these measurements that were within the range of 10-11 g/dL was calculated for each participant.|The evaluation period (weeks 13-37)|The Primary Analysis Set which consists of all randomized participants who had at least 6 hemoglobin measurements during the evaluation period while on study and receiving investigational product.|||percentage of hemoglobin measurements||Standard Deviation|Mean
2592704|NCT02253537|Primary|Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity|Subjects who have clinical signs/symptoms indicating TB and who are receiving or have to start the treatment for active TB were tested. Subjects who were presenting with symptoms suggestive of TB disease and who have a positive acid-fast bacillus (AFB) smear or have Mycobacterium tuberculosis (MTB) in a specimen detected by nucleic acid amplification (NAA) or MTB complex Polymerase Chain Reaction (PCR), and who have received treatment for no more than 14 days upon enrollment.|At time of enrollment||||Participants|||Count of Participants
2592705|NCT02253433|Secondary|Change in Emergency Department (ED) Visits for Asthma|"Self report. The healthcare utilization questions were from the validated CDC-BRFSS Asthma Survey. For this outcome measure, we used patient responses to a question that asked During the past 12 months, how many times to you visit an emergency room of urgent care center because of your asthma?. We collected this information for the 12 months preceding their baseline and exit clinic visits. A higher number of visits suggests poorer asthma control."|At baseline (enrollment) and exit (approximately 12 mo after enrollment)|"One patient from the enhanced in-clinic only group withdrew immediately after consenting.114 control and 79 intervention completed the study. Respondent number less than enrollment and/or exit numbers reflects individuals who chose not to respond to the question."|||visits||Standard Deviation|Mean
2592706|NCT02253433|Primary|Change in Juniper Mini Asthma Quality of Life Questionnaire Score (MiniAQLQ)|Self report. A validated 15-item questionnaire, with each question having seven possible answers score from 1 (worst) to 7 (best). Minimum total score is 15 (worst asthma quality of life). Maximum total score is 105 (best asthma quality of life). By design, an individual's score is reported as the mean (total score/15). Thus the possible mean reported score ranges from 1 (worst asthma quality of life) to 7 (best asthma quality of life).|At baseline (enrollment) and exit (approximately 12 mo after enrollment)|Among the enhanced in-clinic care group, one person withdrew immediately after consent and two individuals chose not to fill out all of the answers, such that a score could not be computer. At exit, 3 control and 1 intervention were missing (1) or incomplete (3).|||score on a scale||Standard Deviation|Mean
2592707|NCT02253433|Primary|Change in Asthma Control Test (ACT) Score|Self report. The ACT is a validated 5-question scale assessing asthma control over the previous four weeks. Each question has five possible responses, from 1 (worst) to 5 (best). The total score ranges from 5 (worst control) to 25 (best control). In general, a total score of 19 or less suggests poor control.|At baseline (enrollment) and exit (approximately 12 mo after enrollment)|At baseline, one individual in each group chose not to answer all five ACT questions; therefore a total ACT score could not be calculated for those two individuals (missing data are addressed in the analyses). At exit, among those who completed the study, one person in the enhanced in-clinic group chose not to answer all five ACT questions.|||score on a scale||Standard Deviation|Mean
2592708|NCT02253394|Primary|Effect of Combination Ambrisentan + Spironolactone on Peak Volume of Oxygen Consumption (pVO2) and Cardiac Output|Study the effect of combination ambrisentan (5-10 mg/d) + spironolactone (50 mg/d) on pVO2 and cardiac output. The pVO2 refers to a measure of general physical fitness measured during exercise.|Up to average of 20 min|Data were not reported due to patient privacy considerations owing to low enrollment.||||||
2592709|NCT02253173|Other Pre-specified|PK Substudy - Hormone Concentration Assessments (Serum Estradiol, Estrone and Estrone Conjugates; SHBG)|Blood samples will be obtained from a subset of subjects at pre-selected sites to characterize PK parameters (AUC, tmax, Cmin, Cmax, Cavg) and to measure SHBG|Pre-treatment, Day 2, Weeks 2 and 12|||||||
2592961|NCT02251886|Primary|Number of Participants With Version of Fetal Breech Position to Cephalic Position up to 4 Weeks After Treatment|Number of Participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment|4 weeks||||participants|||Number
2592710|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) Domain Score - Satisfaction|"Change from Baseline to Week 12 in FSFI Domain Score (Satisfaction) as compared to placebo~The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||95% Confidence Interval|Least Squares Mean
2592711|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) Domain Score - Pain|"Change from Baseline to Week 12 in FSFI Domain Score (Pain) as compared to placebo~The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||95% Confidence Interval|Least Squares Mean
2592712|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) Domain Score - Orgasm|"Change from Baseline to Week 12 in FSFI Domain Score (Orgasm) as compared to placebo~The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||95% Confidence Interval|Least Squares Mean
2592713|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) Domain Score - Lubrication|"Change from Baseline to Week 12 in FSFI Domain Score (Lubrication) as compared to placebo~The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||95% Confidence Interval|Least Squares Mean
2592714|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) Domain Score - Desire|"Change from Baseline to Week 12 in FSFI Domain Score (Desire) as compared to placebo~The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||95% Confidence Interval|Least Squares Mean
2592715|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) Domain Score - Arousal|"Change from Baseline to Week 12 in FSFI Domain Score (Arousal) as compared to placebo~The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||95% Confidence Interval|Least Squares Mean
2592716|NCT02253173|Secondary|Secondary Efficacy Endpoints - Female Sexual Function Index (FSFI) - Total Score|"Change from Baseline to Week 12 in FSFI Total Score as compared to placebo~The FSFI is a brief, multidimensional questionnaire for assessing sexual function in women (Rosen et al., 2000). The questionnaire consists of 19 items that assess sexual function over the past 4 weeks and yield domain scores in six areas: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain. The FSFI questionnaire has a minimum total score of 2.0, a maximum score of 36.0 points and was administered at Baseline and Week 12."|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||95% Confidence Interval|Least Squares Mean
2592717|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Secretions)|"Change from Baseline to Week 12 in Vaginal Secretions as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Secretions: No atrophy (normal clear secretions noted on vaginal walls) = 0; Mild (superficial coating of secretions, difficulty with speculum insertion) = 1; Moderate (scant not covering the entire vaginal vault, may need lubrication with speculum insertion to prevent pain) = 2; Severe (none, inflamed, ulceration noted, need lubrication with speculum insertion to prevent pain] = 3~Severity was assessed by the Investigator at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592718|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Secretions)|"Change from Baseline to Week 8 in Vaginal Secretions as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Secretions: No atrophy (normal clear secretions noted on vaginal walls) = 0; Mild (superficial coating of secretions, difficulty with speculum insertion) = 1; Moderate (scant not covering the entire vaginal vault, may need lubrication with speculum insertion to prevent pain) = 2; Severe (none, inflamed, ulceration noted, need lubrication with speculum insertion to prevent pain] = 3~Severity was assessed by the Investigator at Baseline and Week 8"|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592719|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Secretions)|"Change from Baseline to Week 6 in Vaginal Secretions as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Secretions: No atrophy (normal clear secretions noted on vaginal walls) = 0; Mild (superficial coating of secretions, difficulty with speculum insertion) = 1; Moderate (scant not covering the entire vaginal vault, may need lubrication with speculum insertion to prevent pain) = 2; Severe (none, inflamed, ulceration noted, need lubrication with speculum insertion to prevent pain] = 3~Severity was assessed by the Investigator at Baseline and Week 6"|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592720|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Secretions)|"Change from Baseline to Week 2 in Vaginal Secretions as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Secretions: No atrophy (normal clear secretions noted on vaginal walls) = 0; Mild (superficial coating of secretions, difficulty with speculum insertion) = 1; Moderate (scant not covering the entire vaginal vault, may need lubrication with speculum insertion to prevent pain) = 2; Severe (none, inflamed, ulceration noted, need lubrication with speculum insertion to prevent pain) = 3~Severity was assessed by the Investigator at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592721|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Surface Thickness)|"Change from Baseline to Week 12 in Vaginal Epithelial Surface Thickness as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Epithelial Surface Thickness: No atrophy (rogation and elasticity of vault) = 0; Mild (poor rogation with some elasticity noted of vaginal vault) = 1; Moderate (smooth, some elasticity of vaginal vault) = 2; Severe [smooth, no elasticity, constriction of the upper one third of vagina or loss of vaginal tone (cystocele and rectocele)] = 3~Severity was assessed by the Investigator at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline|||units on a scale||Standard Error|Least Squares Mean
2592722|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Surface Thickness)|"Change from Baseline to Week 8 in Vaginal Epithelial Surface Thickness as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Epithelial Surface Thickness: No atrophy (rogation and elasticity of vault) = 0; Mild (poor rogation with some elasticity noted of vaginal vault) = 1; Moderate (smooth, some elasticity of vaginal vault) = 2; Severe [smooth, no elasticity, constriction of the upper one third of vagina or loss of vaginal tone (cystocele and rectocele)] = 3~Severity was assessed by the Investigator at Baseline and Week 8"|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592723|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Surface Thickness)|"Change from Baseline to Week 6 in Vaginal Epithelial Surface Thickness as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Epithelial Surface Thickness: No atrophy (rogation and elasticity of vault) = 0; Mild (poor rogation with some elasticity noted of vaginal vault) = 1; Moderate (smooth, some elasticity of vaginal vault) = 2; Severe [smooth, no elasticity, constriction of the upper one third of vagina or loss of vaginal tone (cystocele and rectocele)] = 3~Severity was assessed by the Investigator at Baseline and Week 6"|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline|||units on a scale||Standard Error|Least Squares Mean
2592724|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Surface Thickness)|"Change from Baseline to Week 2 in Vaginal Epithelial Surface Thickness as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Epithelial Surface Thickness: No atrophy (rogation and elasticity of vault) = 0; Mild (poor rogation with some elasticity noted of vaginal vault) = 1; Moderate (smooth, some elasticity of vaginal vault) = 2; Severe [smooth, no elasticity, constriction of the upper one third of vagina or loss of vaginal tone (cystocele and rectocele)] = 3~Severity was assessed by the Investigator at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592725|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Integrity)|"Change from Baseline to Week 12 in Vaginal Epithelial Integrity as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Epithelial Integrity: No atrophy (normal) = 0; Mild (vaginal surface bleeds with scraping) = 1; Moderate (vaginal surface bleeds with light contact) = 2; Severe (vaginal surface has petechiae before contact and bleeds with light contact) = 3~Severity was assessed by the Investigator at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline|||units on a scale||Standard Error|Least Squares Mean
2592726|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Integrity)|"Change from Baseline to Week 8 in Vaginal Epithelial Integrity as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Epithelial Integrity: No atrophy (normal) = 0; Mild (vaginal surface bleeds with scraping) = 1; Moderate (vaginal surface bleeds with light contact) = 2; Severe (vaginal surface has petechiae before contact and bleeds with light contact) = 3~Severity was assessed by the Investigator at Baseline and Week 8"|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592727|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Integrity)|"Change from Baseline to Week 6 in Vaginal Epithelial Integrity as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Epithelial Integrity: No atrophy (normal) = 0; Mild (vaginal surface bleeds with scraping) = 1; Moderate (vaginal surface bleeds with light contact) = 2; Severe (vaginal surface has petechiae before contact and bleeds with light contact) = 3~Severity was assessed by the Investigator at Baseline and Week 6"|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592728|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Epithelial Integrity)|"Change from Baseline to Week 2 in Vaginal Epithelial Integrity as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Epithelial Integrity: No atrophy (normal) = 0; Mild (vaginal surface bleeds with scraping) = 1; Moderate (vaginal surface bleeds with light contact) = 2; Severe (vaginal surface has petechiae before contact and bleeds with light contact) = 3~Severity was assessed by the Investigator at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592729|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Color)|"Change from Baseline to Week 12 in Vaginal Color as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Color: No atrophy (pink) = 0; Mild (lighter in color) = 1; Moderate(pale in color) = 2; Severe (transparent/no color or inflamed) = 3 Severity was assessed by the Investigator at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592730|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Color)|"Change from Baseline to Week 8 in Vaginal Color as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Color: No atrophy (pink) = 0; Mild (lighter in color) = 1; Moderate(pale in color) = 2; Severe (transparent/no color or inflamed) = 3 Severity was assessed by the Investigator at Baseline and Week 8"|Baseline to Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592731|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Color)|"Change from Baseline to Week 6 in Vaginal Color as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Color: No atrophy (pink) = 0; Mild (lighter in color) = 1; Moderate(pale in color) = 2; Severe (transparent/no color or inflamed) = 3 Severity was assessed by the Investigator at Baseline and Week 6"|Baseline to Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592732|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Mucosa Assessment (Vaginal Color)|"Change from Baseline to Week 2 in Vaginal Color as compared to placebo~Vaginal Mucosa Assessment Scale - Vaginal Color: No atrophy (pink) = 0; Mild (lighter in color) = 1; Moderate(pale in color) = 2; Severe (transparent/no color or inflamed) = 3 Severity was assessed by the Investigator at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592733|NCT02253173|Secondary|Secondary Efficacy Endpoints - Other VVA Symptoms (Vulvar and/or Vaginal Itching or Irritation)|"Change from Baseline to Week 12 on the severity of vulvar and/or vaginal itching or irritation associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592734|NCT02253173|Secondary|Secondary Efficacy Endpoints - Other VVA Symptoms (Vulvar and/or Vaginal Itching or Irritation)|"Change from Baseline to Week 8 on the severity of vulvar and/or vaginal itching or irritation associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 8"|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592735|NCT02253173|Secondary|Secondary Efficacy Endpoints - Other VVA Symptoms (Vulvar and/or Vaginal Itching or Irritation)|"Change from Baseline to Week 6 on the severity of vulvar and/or vaginal itching or irritation associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 6"|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592736|NCT02253173|Secondary|Secondary Efficacy Endpoints - Other VVA Symptoms (Vulvar and/or Vaginal Itching or Irritation)|"Change from Baseline to Week 2 on the severity of vulvar and/or vaginal itching or irritation associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592737|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness)|"Change from Baseline to Week 12 on the severity of vaginal dryness associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592738|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness)|"Change from Baseline to Week 8 on the severity of vaginal dryness associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 8"|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592739|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness)|"Change from Baseline to Week 6 on the severity of vaginal dryness associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 6"|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592740|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Other VVA Symptoms (Vaginal Dryness)|"Change from Baseline to Week 2 on the severity of vaginal dryness associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592741|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Most Bothersome Symptom (Dyspareunia)|"Change from Baseline to Week 8 on the severity of the MBS of dyspareunia (vaginal pain associated with sexual activity) associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 8"|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592742|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Most Bothersome Symptom (Dyspareunia)|"Change from Baseline to Week 6 on the severity of the MBS of dyspareunia (vaginal pain associated with sexual activity) associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 6"|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592743|NCT02253173|Secondary|Secondary Efficacy Endpoints - Severity of Most Bothersome Symptom (Dyspareunia)|"Change from Baseline to Week 2 on the severity of the MBS of dyspareunia (vaginal pain associated with sexual activity) associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 2"|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592744|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal pH|Change from Baseline to Week 8 in vaginal pH as compared to placebo|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||pH units||Standard Error|Least Squares Mean
2592745|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal pH|Change from Baseline to Week 6 in vaginal pH as compared to placebo|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||pH units||Standard Error|Least Squares Mean
2592746|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal pH|Change from Baseline to Week 2 in vaginal pH as compared to placebo|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||pH units||Standard Error|Least Squares Mean
2592747|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Parabasal Cells|Change from Baseline to Week 8 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||percentage of vaginal parabasal cells||Standard Error|Least Squares Mean
2592748|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Parabasal Cells|Change from Baseline to Week 6 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||percentage of vaginal parabasal cells||Standard Error|Least Squares Mean
2592749|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Parabasal Cells|Change from Baseline to Week 2 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||percentage of vaginal parabasal cells||Standard Error|Least Squares Mean
2592750|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Superficial Cells|Change from Baseline to Week 8 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo|Baseline and Week 8|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 8 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||percentage of vaginal superficial cells||Standard Error|Least Squares Mean
2592751|NCT02253173|Secondary|Secondary Efficacy Endpoints- Vaginal Superficial Cells|Change from Baseline to Week 6 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo|Baseline and Week 6|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 6 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||percentage of vaginal superficial cells||Standard Error|Least Squares Mean
2592752|NCT02253173|Secondary|Secondary Efficacy Endpoints - Vaginal Superficial Cells|• Change from Baseline to Week 2 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo|Baseline and Week 2|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 2 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||percentage of vaginal superficial cells||Standard Error|Least Squares Mean
2592753|NCT02253173|Primary|Co-Primary Efficacy Endpoint - Severity of Most Bothersome Symptom (Dyspareunia)|"• Change from Baseline to Week 12 on the severity of the MBS of dyspareunia (vaginal pain associated with sexual activity) associated with VVA as compared to placebo~VVA Symptoms Self-Assessment Questionnaire Severity Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe.~Subjects assessed severity at Baseline and Week 12"|Baseline and Week 12|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2592754|NCT02253173|Primary|Co-Primary Efficacy Endpoint - Vaginal pH|• Change from Baseline to Week 12 in vaginal pH as compared to placebo|Baseline and 12 Weeks|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||pH units||Standard Error|Least Squares Mean
2592755|NCT02253173|Primary|Co-Primary Efficacy Endpoint - Vaginal Parabasal Cells|• Change from Baseline to Week 12 in the percentage of vaginal parabasal cells (by vaginal cytologic smear) compared to placebo|Baseline and 12 Weeks|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||percentage of vaginal parabasal cells||Standard Error|Least Squares Mean
2592756|NCT02253173|Primary|Co-Primary Efficacy Endpoint - Vaginal Superficial Cells|• Change from Baseline to Week 12 in the percentage of vaginal superficial cells (by vaginal cytologic smear) compared to placebo|Baseline and 12 Weeks|For the statistical test utilized (MMRM), the number of subjects analyzed varied based on if they had both Baseline and Week 12 data so it would not necessarily match the overall number of subjects in the MITT Population at Baseline.|||percentage of vaginal superficial cells||Standard Error|Least Squares Mean
2592757|NCT02253160|Secondary|MNC Product Contamination/Purity - RBC Concentration (10^6/µL)||within 5 minutes upon completion of procedure||||RBC*10^6/µL||Standard Deviation|Mean
2592758|NCT02253160|Secondary|MNC Collection Efficiency (CE2%)|Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE2 is a measurement of device performance calculated using donor blood counts immediately before and blood product counts immediately after the collection procedure and does not average the donor pre- and post-collection counts. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure||||percent||Standard Deviation|Mean
2592759|NCT02253160|Other Pre-specified|Post-collection Platelet Loss in Subject|The percent change from pre-collection platelet count to post-collection subject platelet count.|24-hours after last collection procedure||||percent change||Standard Deviation|Mean
2592760|NCT02253160|Other Pre-specified|Device Deficiencies|Any time a device or disposable does not function as described in the Operator's Manual or Package Insert, a Device Deficiency must be reported. This includes those instances wherein Operator Error led to a malfunction/deficiency. A device deficiency is any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in the information supplied by the manufacturer. Device malfunctions and device incidents should be reported in the same manner.|24-hours after last collection procedure|All pivotal subjects (n=22) received both the Spectra Optia and the COBE Spectra per the crossover design. The lead-in subject only received the Spectra Optia. Both lead-in and pivotal subjects are included in any safety analysis.|||events|||Number
2592761|NCT02253160|Secondary|Procedure Time (Minutes)||within 5 minutes upon completion of procedure||||minutes||Standard Deviation|Mean
2592762|NCT02253160|Secondary|Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL)|A small amount of plasma typically used for processing was collected in a sub-set of collection procedures.|within 5 minutes upon completion of procedure|Five collections also collected plasma for this sub-study.|||cells*10^3/µL||Standard Deviation|Mean
2592764|NCT02253160|Secondary|MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %)|Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for platelets. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure|One subject was not included in MNC CE1 because of missing MNC lab results post-collection, therefore CE1 could not be calculated.|||percent||Standard Deviation|Mean
2592765|NCT02253160|Secondary|MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL)||within 5 minutes upon completion of procedure||||cells*10^3/µL||Standard Deviation|Mean
2592766|NCT02253160|Secondary|MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL)||within 5 minutes upon completion of procedure||||cells*10^3/mL||Standard Deviation|Mean
2592767|NCT02253160|Secondary|MNC Product Contamination/Purity (%) - Hematocrit (%)||within 5 minutes upon completion of procedure||||% of red blood cells||Standard Deviation|Mean
2592768|NCT02253160|Secondary|CD34+ Per kg of Body Weight||within 5 minutes upon completion of procedure||||cells/kg||Standard Deviation|Mean
2592769|NCT02253160|Secondary|MNC Collection Efficiency (CE1%)|Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure|One subject was not included in MNC CE1 because of missing MNC lab results post-collection, therefore CE1 could not be calculated.|||percent||Standard Deviation|Mean
2592770|NCT02253160|Secondary|CD34+ Collection Efficiency (CE2 %)|Comparison of collection efficiencies associated with the CMNC Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor blood counts immediately before and blood product blood counts immediately after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure||||percent||Standard Deviation|Mean
2592771|NCT02253160|Primary|CD34+ Collection Efficiency (CE1 %)|The primary endpoint is the CD34+ cell collection efficiency (CE) associated with the Mononuclear Cell (CMNC) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the CMNC collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.|within 5 minutes upon completion of procedure||||percent||Standard Deviation|Mean
2592772|NCT02253147|Secondary|Number of Subjects Receiving Re-treatment||Weeks 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits (See participant flow)|||Participants|||Count of Participants
2592773|NCT02253147|Secondary|Number of Subjects Receiving Touch-up Treatment||Week 2||||Participants|||Count of Participants
2592774|NCT02253147|Secondary|Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up)||Week 2||||mL||Standard Deviation|Mean
2592775|NCT02253147|Secondary|Subject's Satisfaction Score|Subjective 5-point scale with 1 being 'very satisfied' and 5 being 'very dissatisfied'|Weeks 2, 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||units on a scale||Standard Deviation|Mean
2592776|NCT02253147|Secondary|Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire|"The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective.~FACE-Q questionnaire is composed of 5 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely').~The subject was instructed as follows: These questions ask about how you look right now. With your nasolabial folds in mind (the deep lines that run downward from the sides of your nose), in the past week, how much have you been bothered by:, and provided response.~How deep your nasolabial fold are?~How your nasolabial folds look when your face is relaxed (still)?~How old your nasolabial folds make you look?~How your nasolabial folds look when you smile?~How your nasolabial folds look compared with other people your age? To calculate the FACE-Q, outcomes from all 5 questions were pooled and adapted to a scale to 100 units. Data were also transformed so that higher scores reflected a beneficial outcome."|Immediately post-injection, and weeks 2, 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||units on a scale||Standard Deviation|Mean
2592777|NCT02253147|Secondary|"Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale."|"Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of much improved, improved, no change, worse, and much worse.~GAI was assessed using the baseline photograph. Subjects will be instructed: Use a mirror to compare your face to the photograph provided to you and rate the degree of aesthetic improvement by using the following scale.~Each side of the face was assessed independently."|Weeks 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||Participants|||Count of Participants
2592778|NCT02253147|Secondary|"Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE)"|"Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of much improved, improved, no change, worse, and much worse.~GAI was assessed using the baseline photograph. Each side of the face was assessed independently."|Weeks 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||Participants|||Count of Participants
2592791|NCT02252965|Secondary|Percentage of Subjects With Hypoglycemia|Hypoglycemia, also called as low blood glucose or low blood sugar, is defined as the blood glucose level of less than normal (that is less than 3.9 millimole per liter [mmol/L]).|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.|||percentage of subjects||95% Confidence Interval|Number
2592779|NCT02253147|Secondary|Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI|A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to baseline|Baseline and Weeks 2, 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||percentage of responders||95% Confidence Interval|Number
2592780|NCT02253147|Secondary|Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE|A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to Baseline|Baseline and Weeks 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||percentage of responders||95% Confidence Interval|Number
2592781|NCT02253147|Secondary|Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI)|WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.|Baseline and Weeks 2, 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||units on a scale||Standard Deviation|Mean
2592782|NCT02253147|Secondary|Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE)|WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.|Baseline and Weeks 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||units on a scale||Standard Deviation|Mean
2592783|NCT02253147|Secondary|Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®|VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain|During Injection and 5, 15, 30 minutes post-injection|VAS are presented for the SAFT population (N=120) (see pre-assignment details) Number of patients for pain assessment after touch-up treatment are based on number of patients receiving Touch-up treatment|||units on a scale||Standard Deviation|Mean
2592784|NCT02253147|Secondary|Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®|"The subjects received a diary booklet and instructions for recording his/her observations of the Common Treatment Responses of the study treatments for the first 14 days after each treatment (initial, touch-up). The diary was discussed during each telephone follow-up visit. Subjects should complete the diary at approximately the same time each day (i.e., am or pm).~The subject diary captured the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and other.~The 14-day patient CTR diary included a detailed glossary describing all signs/symptoms listed in the diary; an option was provided to rate other if the subject experienced a sign/symptom that is not listed.~The table presents the number of subjects experiencing at least 1 Common Treatment Response (CTR)"|During 14 days after initial treatment (D0) and touch-up (2 weeks)|CTR are presented for the SAFT population (N=120) (see pre-assignment details) Number of patients for CTR after touch-up treatment are based on number of patients receiving Touch-up treatment (RHA-UD N=32/Perl N=47)|||Participants|||Count of Participants
2592785|NCT02253147|Primary|Non-inferiority of the Delta of the WSRS Score Between W24 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe Naso-Labial Folds Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the BLE.|"WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.~BLE =Blinded Live Evaluator"|Baseline and 24 weeks after last treatment||||units on a scale||95% Confidence Interval|Mean
2592786|NCT02252965|Secondary|Percentage of Subjects Who Are Compliant to Treatment|Compliance was defined as not skipping or forgetting dosing or not delaying the dosing time. Subjects who never missed a dose of medication were considered compliant.|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.|||percentage of subjects|||Number
2592787|NCT02252965|Secondary|Percentage of Subjects With HbA1c Less Than (<) 7% and With no Severe Gastrointestinal (GI) and Other Adverse Events (AEs)|Percentage of subjects with HbA1c <7% and with no severe GI and other AEs were reported. Severe adverse events were based on Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 and were defined as those events which were medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL). Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.|Baseline up to Week 16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat.|||percentage of subjects||95% Confidence Interval|Number
2592788|NCT02252965|Secondary|Percentage of Subjects Who Are Totally Intolerant to the Treatment|Subjects were considered to be totally intolerant if they experienced a Grade 3 or higher toxicity considered at least possibly related to the treatment.|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.|||percentage of subjects||95% Confidence Interval|Number
2592789|NCT02252965|Secondary|Percentage of Subjects With HbA1c Less Than (<) 7%||Baseline up to Week 16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat.|||percentage of subjects||95% Confidence Interval|Number
2592790|NCT02252965|Secondary|Percentage of Subjects With Marked Hyperglycemia|Marked hyperglycemia was defined as the FPG level of greater than or equal to 11.1 mmol/L.|Baseline up to Week 16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat.|||percentage of subjects||95% Confidence Interval|Number
2592833|NCT02252536|Secondary|Weekly Mean Number of Drinks Per Week|Timeline Follow Back data used to calculate the weekly mean number of drinks per week|Weeks 22-25||||drinks per week||Standard Error|Least Squares Mean
2592792|NCT02252965|Secondary|Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) Level at Weeks 8 and 16|The 2-hour Postprandial plasma glucose (PPG) level refers to the plasma glucose concentrations after 2 hours of eating.|Baseline, Week 8 and 16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure. Here “n” signifies those subjects who were evaluable for the specified time points for each arm, respectively.|||mmol/L||Standard Deviation|Mean
2592793|NCT02252965|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) Level at Week 1, 2, 4, 8, 12 and 16||Baseline, Week 1, 2, 4, 8, 12,16|ITT population included all subjects who were randomly allocated to a treatment based on the intention to treat. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure. Here “n” signifies those subjects who were evaluable for the specified time points for each arm, respectively.|||Millimole Per Liter (mmol/L)||Standard Deviation|Mean
2592794|NCT02252965|Secondary|Percentage of Subjects With Pre-specified Gastrointestinal Adverse Events During Treatment Period|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Number of subjects with pre-specified gastrointestinal adverse events (diarrhea, nausea, abdominal pain, bloating, constipation, dyspepsia and flatulence) were reported.|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.|||percentage of subjects||95% Confidence Interval|Number
2592795|NCT02252965|Primary|Overall Gastrointestinal (GI) Tolerability Assessed as Percentage of Subjects With Gastrointestinal Adverse Events During Treatment Period|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product.|Baseline up to Week 16|The safety population included all subjects who received at least 1 dose of trial treatment.|||percentage of subjects||95% Confidence Interval|Number
2592796|NCT02252965|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16||Baseline, Week 16|"Per-protocol (PP) population included all subjects who were randomly allocated to a treatment based on intent to treat and were compliant with protocol (absence of any major protocol violations). Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||Percentage of HbA1c||Standard Error|Least Squares Mean
2592797|NCT02252939|Secondary|QuickDASH (Disability of the Arm, Shoulder, and Hand)||Day 1, baseline|Data were not collected||||||
2592798|NCT02252939|Secondary|Factors Associated With Thumb Pain: Hyperextension of Metacarpophalangeal Joint|Thumb pain measured on a scale of 0-10 and dichotomized by having thumb pain (yes/no), hyperextension dichotomized (yes/no)|Day 1, baseline|All patients with TMC Arthrosis analyzed for hyperextension of MCP joint.|||Participants|||Count of Participants
2592799|NCT02252939|Primary|Factors Associated With Eaton Classification of Trapeziometacarpal Arthrosis: Age|Radiographs were scored using the Eaton score range.The Eaton score ranges from 1-4 where 1 is the least severe and 4 is the most severe for arthritis. Patients without TMC Arthritis would have a score of 0. Patients' age measured in years.|Baseline at Day 1|"Patients presenting to the Orthopaedic Hand Service not seeking care for TMC Arthrosis~X-Ray: X-ray as part of standard care"|||Years||Inter-Quartile Range|Median
2592800|NCT02252744|Primary|Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease||1 day||||participants|||Number
2592801|NCT02252718|Primary|Interrater Variability (IV)|The outcome measures were interrater variability in the stool assessment by the parent and MD1 made in vivo and in the assessment by the parent in vivo and by MD2 based on the photograph(s). The IV was evaluated by calculating the proportion of exact agreement and the κ statistics for nominal data (colour) and weighted κ values for items in which there is a natural ordering of categories (consistency and amount). Correlation, based on the value of kappa (κ), was categorized as poor (κ ≤ 0.2), fair (0.21 ≤ κ ≤ 0.40), moderate (0.41 ≤ κ ≤ 0.60), good (0.61 ≤ κ ≤ 0.80) or excellent (0.81 ≤ κ ≤ 1.00).|<5min after defecation||||kappa value||95% Confidence Interval|Number
2592802|NCT02252666|Other Pre-specified|Video Nystagmography (VNG)|VNG is a standardized eye tracking test used to measure static and dynamic eye movement control to detect oculomotor abnormalities typically associated with degenerative neurological disorders, particularly in the brainstem and cerebellum. The subject wears goggles while an infrared video camera monitors and records eye movement as the eyes follow a dot on a computer screen.|Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks|The VNG was exploratory and opportunistic. The results are not available as the software to perform the quantitative data analysis is still under development.||||||
2592803|NCT02252666|Secondary|Modified Rivermead Mobility Index|"An 8 item assessment that quantifies the ability to perform transfers. It has been validated in persons with stroke and a mixed neurologic population (43% MS). Score is a 0-40 scale. A higher score indicates higher function. Performance-based and tested in participants who possessed the ability to perform the assessment. Effect size is reported (quantified difference between baseline and time point). The larger the absolute value, the stronger the effect. Cohen's guidelines for social sciences indicate 0.10 as a small effect size, 0.30 as a medium effect size, and 0.50 as a large effect size."|Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks|Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.|||percentage of change|||Number
2592804|NCT02252666|Secondary|Slump Test|Measures and quantifies changes in trunk control during functional sitting. It was quickly determined that this test duplicated the TIS and was difficult to score objectively so the decision was made not to use it for the study. Performance-based and tested in participants who possessed the ability to perform the assessment.|Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks|The Slump Test was ultimately not used because the investigators decided to use the TIS instead. The TIS was realized to be the more appropriate assessment of the two, and the investigators wanted to avoid both data redundancy and test fatigue||||||
2592805|NCT02252666|Secondary|Gross Motor Function Measure (GMFM)|"The GMFM a standardized observational instrument that measures change in gross motor function. Subscales include lying & rolling; sitting; crawling & kneeling; standing; and walking, running & jumping. For the complete test, the raw scores are converted to a 0-100 scale, with higher scores indicating greater functional mobility. The items that we used were scored on a 0-3 scale and changes reported in percent improvement. Performance-based and tested in participants who possessed the ability to perform the assessment. Effect size is reported (quantified difference between baseline and time point). The larger the absolute value, the stronger the effect. Cohen's guidelines for social sciences indicate 0.10 as a small effect size, 0.30 as a medium effect size, and 0.50 as a large effect size."|Change from Baseline at 6, 11, 16, 21 and 27 weeks|Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.|||percentage of change|||Number
2592806|NCT02252666|Secondary|Modified Fatigue Impact Scale (MFIS)|"A self-report tool that assesses the perceived impact of fatigue on daily activities. Consists of 21 items selected from the Fatigue Impact Scale. Scored on a 0-84 scale. A higher score indicates a greater impact of fatigue on daily activities. Effect size is reported (quantified difference between baseline and time point). The larger the absolute value, the stronger the effect. Cohen's guidelines for social sciences indicate 0.10 as a small effect size, 0.30 as a medium effect size, and 0.50 as a large effect size."|Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks|Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.|||percentage of change|||Number
2592807|NCT02252666|Secondary|Multiple Sclerosis Impact Scale (MSIS-29) - Psychological|"A 29-item self-report tool that measures the impact of MS on day-to-day life. There are 3 scores, physical, psychological, and total score. Raw scores are transformed to a 0-100 scale. A higher score indicates a greater impact of disease on daily function. Effect size is reported (quantified difference between baseline and time point). The larger the absolute value, the stronger the effect. Cohen's guidelines for social sciences indicate 0.10 as a small effect size, 0.30 as a medium effect size, and 0.50 as a large effect size."|Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks|Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.|||percentage of change|||Number
2592808|NCT02252666|Secondary|Multiple Sclerosis Impact Scale (MSIS-29) - Physical|"A 29-item self-report tool that measures the impact of MS on day-to-day life. There are 3 scores, physical, psychological, and total score. Raw scores are transformed to a 0-100 scale. A higher score indicates a greater impact of disease on daily function. Effect size is reported (quantified difference between baseline and time point). The larger the absolute value, the stronger the effect. Cohen's guidelines for social sciences indicate 0.10 as a small effect size, 0.30 as a medium effect size, and 0.50 as a large effect size."|Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks|Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.|||percentage of change|||Number
2592809|NCT02252666|Secondary|Box & Blocks (B&B) Assessment - Left|"A standardized clinical assessment of gross upper limb dexterity. Subjects move small blocks from one side of a box to the other within a time period (one minute). Each side is tested separately. The score is the number of blocks moved from 0-150. A higher score indicates improvement. Effect size is reported (quantified difference between baseline and time point). The larger the absolute value, the stronger the effect. Cohen's guidelines for social sciences indicate 0.10 as a small effect size, 0.30 as a medium effect size, and 0.50 as a large effect size."|Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks|Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.|||percentage of change|||Number
2592810|NCT02252666|Secondary|Box & Blocks (B&B) Assessment - Right|"A standardized clinical assessment of gross upper limb dexterity. Subjects move small blocks from one side of a box to the other within a time period (one minute). Each side is tested separately. The score is the number of blocks moved from 0-150. A higher score indicates improvement. Effect size is reported (quantified difference between baseline and time point). The larger the absolute value, the stronger the effect. Cohen's guidelines for social sciences indicate 0.10 as a small effect size, 0.30 as a medium effect size, and 0.50 as a large effect size."|Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks|Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.|||percentage of change|||Number
2592811|NCT02252666|Secondary|12-item MS Walking Scale (MSWS-12)|"A 12-item self-report measure of the impact of MS on a person's walking. Raw scores are transformed to a 0-100 scale. A reduction in score indicates improvement. Effect size is reported (quantified difference between baseline and time point). The larger the absolute value, the stronger the effect. Cohen's guidelines for social sciences indicate 0.10 as a small effect size, 0.30 as a medium effect size, and 0.50 as a large effect size."|Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks|Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.|||percentage of change|||Number
2592834|NCT02252536|Secondary|Percentage of Heavy Drinking Days Per Week|Timeline Follow Back data used to calculate the % of heavy drinking days per week. Heavy drinking is 4+ drinks per day for females and 5+ drinks per day for males|Weeks 22-25||||percentage of days||Standard Error|Least Squares Mean
2592835|NCT02252536|Secondary|Percentage of Days Abstinent Per Week|Timeline Follow Back daily drinking data used to calculate the % of days abstinent per week.|Weeks 22-25||||percentage of days||Standard Error|Least Squares Mean
2592812|NCT02252666|Secondary|Walking Speed|"Assessed by timing the first 25 feet that the person walked. Performance-based and tested in participants who possessed the ability to perform the assessment. Effect size is reported (quantified difference between baseline and time point). The larger the absolute value, the stronger the effect. Cohen's guidelines for social sciences indicate 0.10 as a small effect size, 0.30 as a medium effect size, and 0.50 as a large effect size."|Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks|Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.|||percentage of change|||Number
2592813|NCT02252666|Secondary|Walking Distance|"Clinician measures how far the individual can walk until fatigue requires him/her to stop. Longer distances demonstrate improvement. Performance-based and tested in participants who possessed the ability to perform the assessment. Effect size is reported (quantified difference between baseline and time point). The larger the absolute value, the stronger the effect. Cohen's guidelines for social sciences indicate 0.10 as a small effect size, 0.30 as a medium effect size, and 0.50 as a large effect size."|Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks|Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.|||percentage of change|||Number
2592814|NCT02252666|Secondary|Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)|"A brief, clinician-administered test that helps determine the neuropsychological status of adults who have neurologic injury or disease such as dementia, head injury, and stroke. This tool consists of a battery of tests. Raw scores are transformed to a 0-120 scale, with a higher score indicating higher function. Effect size is reported (quantified difference between baseline and time point). The larger the absolute value, the stronger the effect. Cohen's guidelines for social sciences indicate 0.10 as a small effect size, 0.30 as a medium effect size, and 0.50 as a large effect size."|Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks|Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.|||percentage of change|||Number
2592815|NCT02252666|Secondary|Bowel Control Scale (BWCS)|"A 5-item self-report scale to evaluate the impact of bowel control on lifestyle. This assessment is used for subjects with bowel issues. Scores can range from 0-26, with higher scores indicating greater bowel control problems. Symptom specific test, only used for participants who presented symptom. Effect size is reported (quantified difference between baseline and time point). The larger the absolute value, the stronger the effect. Cohen's guidelines for social sciences indicate 0.10 as a small effect size, 0.30 as a medium effect size, and 0.50 as a large effect size."|Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks|Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.|||percentage of change|||Number
2592816|NCT02252666|Secondary|Bladder Control Scale (BLCS)|"A 4-item self-report scale to evaluate the impact of bladder control on lifestyle. This assessment is used for subjects with bladder issues. Scores can range from 0-22, with higher scores indicating greater bladder control problems. Symptom specific test, only used for participants who presented symptom. Effect size is reported (quantified difference between baseline and time point). The larger the absolute value, the stronger the effect. Cohen's guidelines for social sciences indicate 0.10 as a small effect size, 0.30 as a medium effect size, and 0.50 as a large effect size."|Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks|Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.|||percentage of change|||Number
2592817|NCT02252666|Secondary|Medical Outcomes Study (MOS) Pain Effects Scale (PES)|"A self-report scale that assesses the ways in which pain and unpleasant sensation interfere with mood, ability to walk or move, sleep, work, recreation, and enjoyment of life. This assessment is used for subjects who have pain. Scores can range from 6-30. Items are scaled so that higher scores indicate a greater impact of pain on a patient's mood and behavior. Symptom specific test, only used for participants who presented symptom. Effect size is reported (quantified difference between baseline and time point). The larger the absolute value, the stronger the effect. Cohen's guidelines for social sciences indicate 0.10 as a small effect size, 0.30 as a medium effect size, and 0.50 as a large effect size."|Change from Baseline at 2, 6, 11, 16, and 21 weeks|Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.|||percentage of change|||Number
2592818|NCT02252666|Secondary|Impact of Visual Impairment Scale (IVIS)|"A 5-item self-report questionnaire that assesses the extent to which various activities dependent upon vision are affected by MS-related visual problems. Scores range from 0-15, with higher scores indicating a greater impact of visual problems on daily activities. Effect size is reported (quantified difference between baseline and time point). The larger the absolute value, the stronger the effect. Cohen's guidelines for social sciences indicate 0.10 as a small effect size, 0.30 as a medium effect size, and 0.50 as a large effect size."|Change from Baseline at 2, 6, 11, 16, and 21 weeks|Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.|||percentage of change|||Number
2592855|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 36 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 36 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose|||Number
2594353|NCT02233738|Secondary|Brief Symptom Inventory (BSI-18) at Baseline|Min value:0 Max value:72 Higher score indicates higher psychological distress|30 days prior to Baseline||||score on a scale||Standard Deviation|Mean
2592819|NCT02252666|Secondary|Static Standing Balance Test|"Clinician measures standing balance for up to 30 seconds in each of 5 conditions: feet 10 cm apart, feet together, stride stance, tandem stance, and single leg stance with eyes open and eyes closed. Total score is the sum of all 5 conditions. Higher scores indicate better balance. Performance-based and tested in participants who possessed the ability to perform the assessment. Effect size is reported (quantified difference between baseline and time point). The larger the absolute value, the stronger the effect. Cohen's guidelines for social sciences indicate 0.10 as a small effect size, 0.30 as a medium effect size, and 0.50 as a large effect size."|Change from Baseline at 2, 6, 11, 16, 21 and 27 weeks|Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.|||percentage of change|||Number
2592820|NCT02252666|Primary|Trunk Impairment Scale (TIS)|"Static and dynamic sitting balance and trunk coordination are evaluated by a clinician. It is scored on a scale from 0-23, where the higher the score, the more improved the balance. Effect size is reported (quantified difference between baseline and time point). The larger the absolute value, the stronger the effect. Cohen's guidelines for social sciences indicate 0.10 as a small effect size, 0.30 as a medium effect size, and 0.50 as a large effect size."|Change from Baseline at 2, 6, 11, 16, and 21 weeks|Effect sizes from baseline reported for 4 subjects with EDSS 6.5 - 7.0. It was postulated that the physical limitations of two subjects with EDSS score of 7.5 presented special challenges to measuring changes in function with the available assessment mechanisms for this clinical population.|||percentage of change|||Number
2592821|NCT02252562|Other Pre-specified|Hand Hygiene Events Per Hour Utilizing the Device|The number of times non-scrubbed personnel (anesthesia providers and circulating nurses) perform hand hygiene during OR cases for the treatment group.|During active OR cases|A control arm was not tabulated as the control group did not utilize the study device.|||hand decontamination event per hour||Standard Deviation|Mean
2592822|NCT02252562|Secondary|Hospital Duration|Duration of Hospital Stay|30 days after surgery|Data was not collected||||||
2592823|NCT02252562|Secondary|Mortality|Patient Mortality|Within 30 Days of discharge||||Participants|||Count of Participants
2592824|NCT02252562|Secondary|Hospital Re-admission Rates|Readmission to the hospital within 30 days of discharge|Within 30 days of discharge|Data was not collected.||||||
2592825|NCT02252562|Primary|Number of Participants With Postoperative Healthcare Acquired Infections|Patients with a prior infection and/or preexisting decolonization will be included and will be expected to be equally distributed between study groups given the randomized study design. For HCAI analysis, only new infection sites and/or a different organism of infection will be considered a new HCAI, per NHSN definitions.|30-day after surgery||||Participants|||Count of Participants
2592826|NCT02252536|Secondary|Beck Depression Inventory - II|"The BDI-II is a 21-item multiple choice questionnaire that is used for measuring the severity of depression (Beck et al-1966). Each item is scored on a scale value of 0 to 3. The standardized cutoffs for depression severity are:~0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression"|Week 26||||score||Standard Error|Least Squares Mean
2592827|NCT02252536|Secondary|Beck Anxiety Inventory (BAI) Score|The BAI consists of 21 questions about how the subject has been feeling in the last week, expressed as common symptoms of anxiety (such as numbness and tingling, sweating not due to heat, and fear of the worst happening). This inventory was designed to minimize the overlap with depression scales (Beck et al-1988).The BAI has a maximum score of 63. The standardized cutoffs for anxiety severity are: 0-7: minimal level of anxiety 8-15: mild anxiety 16-25: moderate anxiety 26-63: severe anxiety|Week 26||||score||Standard Error|Least Squares Mean
2592828|NCT02252536|Secondary|Pittsburgh Sleep Quality Index (PSQI) Score|"The PSQI is a 19-item questionnaire assessing the subject's overall sleep experience in the past 30 days (Buysse et al-1989). The lower the overall score, the better the person sleeps. The tool has an adequate internal reliability, validity and consistency for clinical and community samples of the various populations. Range is (0-21); >6 indicative of poor sleep quality."|Week 26||||score||Standard Error|Least Squares Mean
2592829|NCT02252536|Secondary|Alcohol Related Consequences (ImBIBe) Score|"ImBIBe is a 15-item questionnaire in which the subject responds on a 5-point scale (0-4) responses to questions on the consequences of alcohol use. This scale was adapted from the Drinker Inventory of Consequences questionnaire based on FDA recommendations on patient reported outcomes (Miller & Tonigen-1995). The potential range is 0-60. A higher score indicates a worse outcome. The questions are added together. A question that is missing is imputed with the average value of all other questions in the questionnaire.The total score is the sum of the individual item scores.~Mixed effects models as stated in Section 9.4.3 will be generated for the total score. Covariates for these models will be identified"|Weeks 24 and 26||||total score||Standard Error|Least Squares Mean
2592830|NCT02252536|Secondary|Alcohol Craving Score [Alcohol Craving Scale - Short Form (ACQ-SR-R)]|"The ACQ-SR-R contains 12-items adapted from the 47-item ACQ-NOW developed by Singleton et al (1994) to assess craving for alcohol among alcohol users in the current context (right now). Each item has a 1 to 7 raw score (from strongly disagree to strongly agree). Items 3, 8, and 11 are reverse keyed. A general craving index is derived by summing all items and dividing by 12. Minimum score is 1 and maximum score is 7. Higher scores are indicative of higher craving.~Mixed effects models as stated in Section 9.4.3 of the SAP will be generated for the total score and for the 4 subscales. Covariates for these models will be identified"|Weeks 24 and 26||||scores on a scale||Standard Error|Least Squares Mean
2592831|NCT02252536|Secondary|Cigarettes Per Week Among Smokers|"A quantity frequency interview of three questions to assess cigarette smoking behavior and other tobacco/nicotine containing products use during the study: 1) Over the past week, on how many days did you smoke cigarettes?, 2) On the days you smoked during the past week, how many cigarettes did you smoke on average?, and 3) Have you used any other tobacco or nicotine containing products besides cigarettes in the past week (e.g., cigars, cigarellos, pipes, bidis, or smokeless tobacco such as pan, chewing tobacco, or snuff, or nicotine replacement therapies such as patch or gum)?."|Weeks 22-25||||cigarettes per week||Standard Error|Least Squares Mean
2592832|NCT02252536|Secondary|Weekly Mean Drinks Per Drinking Day|Timeline Follow Back daily drinking data used to calculate the weekly mean drinks per drinking day|Weeks 22-25||||drinks per drinking day||Standard Error|Least Squares Mean
2592836|NCT02252536|Secondary|Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 2-levels|"Timeline Follow Back data is used to calculate the % of participants that decrease at least 1-level WHO drinking risk category. The WHO has developed a drinking risk categorical scale that can be used in a responder analysis approach to assess clinically relevant decreases in alcohol consumption (Aubin et al-2015). The WHO 1- and 2-level decrease endpoints are the percentage of subjects experiencing at least 1- and 2-level decrease in WHO levels of alcohol consumption, respectively, from the level at baseline (the period including the 28 days before screening) to the level during the last 4 weeks of the maintenance phase (Study Weeks 22-25). The WHO levels are as follows:~Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g"|Weeks 22-25||||Participants|||Count of Participants
2592837|NCT02252536|Secondary|Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 1-level|"Timeline Follow Back data is used to calculate the % of participants that decrease at least 1-level WHO drinking risk category. The WHO has developed a drinking risk categorical scale that can be used in a responder analysis approach to assess clinically relevant decreases in alcohol consumption (Aubin et al-2015). The WHO 1- and 2-level decrease endpoints are the percentage of subjects experiencing at least 1- and 2-level decrease in WHO levels of alcohol consumption, respectively, from the level at baseline (the period including the 28 days before screening) to the level during the last 4 weeks of the maintenance phase (Study Weeks 22-25). The WHO levels are as follows:~Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g"|Weeks 22-25||||Participants|||Count of Participants
2592838|NCT02252536|Secondary|Percentage of Subjects Abstinent From Alcohol (Key Secondary Endpoint)|Timeline Follow-back drinking data is used to calculate the % of subjects that report not drinking alcohol during weeks 22-25|Weeks 22-25|no imputation was performed so the number analyzed is reduced|||Participants|||Count of Participants
2592839|NCT02252536|Primary|Percentage of Subjects With no Heavy Drinking Days (PSNHDD)|The primary objective of the study is to compare the efficacy of HORIZANT (gabapentin enacarbil) Extended-Release Tablets 600 mg twice daily (BID) with matched placebo on the primary alcohol consumption outcome endpoint, percentage of subjects with no heavy drinking days (PSNHDD) during the last 4 weeks of treatment, among patients with Alcohol Use Disorder (AUD).|Weeks 22-25||||percentage of subjects with NHDD|||Number
2592840|NCT02252445|Secondary|Analgesics|The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients infused with tramadol were counted.|||participants|||Number
2592841|NCT02252445|Secondary|Dizziness|Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with dizziness were counted.|||participants|||Number
2592842|NCT02252445|Secondary|Blurred Vision|Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with blurred vision were counted.|||participants|||Number
2592843|NCT02252445|Secondary|Flushing|Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with flushing were counted.|||participants|||Number
2592844|NCT02252445|Secondary|Dry Mouth|Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with dry mouth were counted.|||participants|||Number
2592845|NCT02252445|Secondary|Vomiting|Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with vomiting were counted.|||participants|||Number
2592846|NCT02252445|Secondary|Nausea|Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.|0, 1, 6 and 24 hour postoperatively|Patients with nausea were counted.|||participants|||Number
2592847|NCT02252445|Secondary|Hemodynamic Parameters|Mean blood pressure and heart rate will be measured at 0, 1, 5, 10 minute postoperatively. Measurement at 10 minute means Mean blood pressure and heart rate at the admission of post-anesthetic care unit.|0, 1, 5, 10 minute postoperatively||||mmHg||Standard Deviation|Mean
2592848|NCT02252445|Secondary|Catheter-related Bladder Discomfort|Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score >0 will be counted.|0, 6 and 24 hour postoperatively|Patients with score >0 will be counted.|||participants|||Number
2592849|NCT02252445|Primary|Catheter-related Bladder Discomfort|Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score >0 will be counted.|1 hour postoperatively|Patients with score >0 were counted.|||participants|||Number
2592850|NCT02252406|Primary|Impact of Ranolazine on HDL-C Levels in Subjects|Will evaluate the impact of ranolazine in HDL-C levels in women with metabolic syndrome|Change from Baseline to 24 weeks||||percentage of change in HDL||Standard Deviation|Mean
2592851|NCT02252406|Primary|Impact of Ranolazine on Hemoglobin A1C|Will evaluate the impact of ranolazine in HgbA1C in women with Metabolic Syndrome (MBS)|Change from baseline to 24 weeks||||percent change||Standard Deviation|Mean
2592852|NCT02252354|Secondary|Part 2: Clearance (CL) for [14C]-TAK-385|CL is clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in L/hr. CL is a quantitative measure of the rate at which a drug substance is removed from the body. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||L/hr||Standard Deviation|Mean
2592853|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 72 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 72 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose|||Number
2592854|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 48 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 48 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose|||Number
2594354|NCT02233738|Secondary|Quality of Life Survey (QOLS) at 6 Months|Min value:16 Max value:112 Higher score indicates higher quality of life|6 months||||score on a scale||Standard Deviation|Mean
2592856|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 24 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 24 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose|||Number
2592857|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 12 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 12 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose|||Number
2592858|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 8 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 8 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose|||Number
2592859|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 4 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 4 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose|||Number
2592860|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 2 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 2 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose|||Number
2592861|NCT02252354|Primary|Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 1 Post-dose|Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.|Hour 1 post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose|||Number
2592862|NCT02252354|Primary|Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percentage of Dose|Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C.|0 to 144 hours post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose||Standard Deviation|Mean
2592863|NCT02252354|Primary|Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percentage of Dose|Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C.|0 to 191 hours post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of dose||Standard Deviation|Mean
2592864|NCT02252354|Primary|Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percent Radioactivity|Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi).|0 to 144 hours post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of recovered radioactivity||Standard Deviation|Mean
2592865|NCT02252354|Primary|Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percent Radioactivity|Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi).|0 to 191 hours post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage of recovered radioactivity||Standard Deviation|Mean
2592866|NCT02252354|Secondary|Part 2: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces|Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant.|Day 1 pre-dose and various time-points (up to 72 hours) post-dose for urine; Day 1 pre-dose and various time-points (up to 48 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percent recovery of radioactivity||Standard Deviation|Mean
2592867|NCT02252354|Secondary|Part 2: Volume of Distribution (Vz/F) for TAK-385|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||L||Standard Deviation|Mean
2592868|NCT02252354|Secondary|Part 1: Volume of Distribution (Vz/F) for TAK-385|Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||Liter (L)||Standard Deviation|Mean
2592869|NCT02252354|Secondary|Part 2: Apparent Oral Clearance (CL/F) for TAK-385|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr).CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||L/hr||Standard Deviation|Mean
2592870|NCT02252354|Secondary|Part 1: Apparent Oral Clearance (CL/F) for TAK-385|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr). CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||L/hr||Standard Deviation|Mean
2592871|NCT02252354|Primary|Part 2: Absolute Bioavailability for the Oral Tablet Formulation|Absolute bioavailability, defined as the fraction or percentage of the unchanged, orally administered dose that is systemically available, relative to the total dose administered intravenously. AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percentage bioavailability||Standard Deviation|Mean
2592872|NCT02252354|Primary|Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385|Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||hours||Standard Deviation|Mean
2592873|NCT02252354|Primary|Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma Radioactivity for [14C]-TAK-385|Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||hours||Standard Deviation|Mean
2592874|NCT02252354|Primary|Part 2: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385|AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-tau]). AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Geometric Mean
2592875|NCT02252354|Primary|Part 2: AUC(0-168): Area Under the Plasma Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385|AUC(0-168) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval :168 hours in this study (AUC(0-tau]). AUC(0-168) was corrected according to Hamilton Pool result.Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng eq*hr/mL||Standard Deviation|Geometric Mean
2592876|NCT02252354|Primary|Part 2: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385|AUC(0-inf) is measure of area under the curve from time 0 to Infinity.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Geometric Mean
2592877|NCT02252354|Primary|Part 2: AUC(0-inf): Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385|AUC(0-inf) is measure of area under the curve from time 0 to Infinity. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).AUC(0-inf) was corrected according to Hamilton Pool result.Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various sampling time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng eq*hr/mL||Standard Deviation|Geometric Mean
2592878|NCT02252354|Primary|Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for TAK-385|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng/mL||Standard Deviation|Geometric Mean
2592879|NCT02252354|Primary|Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for [14C]-TAK-385|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various time-points (up to 168hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng eq/mL||Standard Deviation|Geometric Mean
2592880|NCT02252354|Primary|Part 2: Tmax : Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||hours||Full Range|Median
2592881|NCT02252354|Primary|Part 2: Tmax : Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax) for [14C]-TAK-385|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to NMT 37.0 kilobecquerel (kBq) (1000 nanocurie [nCi]). Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||hours||Full Range|Median
2592882|NCT02252354|Primary|Part 1: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces|Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant. Total [14-C] determination of urine and feces samples were determined by Liquid Scintillation Counting (LSC).|Day 1 pre-dose and various time-points (up to Day 288) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||percent recovery of radioactivity||Standard Deviation|Mean
2592883|NCT02252354|Primary|Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385|Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||hours||Standard Deviation|Mean
2592884|NCT02252354|Primary|Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma and Whole Blood Radioactivity for [14C]-TAK-385|Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||hours||Standard Deviation|Mean
2592885|NCT02252354|Primary|Part 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385|AUC(0-168) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval -168 hours in this study). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng*hr/mL||Standard Deviation|Geometric Mean
2592886|NCT02252354|Primary|Part 1: AUC(0-168): Area Under the Plasma and Whole Blood Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385|AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-168]). Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng eq*hr/mL||Standard Deviation|Geometric Mean
2592887|NCT02252354|Primary|Part 1: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385|AUC(0-inf) is area under the concentration-time curve from time 0 to infinity. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385) .|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||nanogram hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2592888|NCT02252354|Primary|Part 1: AUC(0-inf): Area Under the Plasma and Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385|AUC(0-inf) is measure of area under the curve from time 0 to infinity. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). AUC(0-inf) was measured in nanogram equivalent*hour per milliliter (ng eq*hr/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng eq*hr/mL||Standard Deviation|Geometric Mean
2592889|NCT02252354|Primary|Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-385|Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2592890|NCT02252354|Primary|Part 1: Cmax: Maximum Observed Plasma and Whole Blood Radioactivity Concentration for [14C]-TAK-385|Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). Cmax was measured in nanogram equivalent per milliliter (ng eq/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||ng eq/mL||Standard Deviation|Geometric Mean
2592891|NCT02252354|Primary|Part 1: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).|Day 1 pre-dose and various time-points (up to 168 hours) post-dose|PK set included all participants in the safety set with at least one measurable plasma concentration.|||hours||Full Range|Median
2592892|NCT02252354|Primary|Part 1: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) for [14C]-TAK-385|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to no more than (NMT) 4.7 millibecquerel (MBq) (127 microcurie [mCi]). Cmax was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by accelerator mass spectrometry (AMS) method.|Day 1 pre-dose and various time-points (up to 288 hours) post-dose|Pharmacokinetic (PK) set included all participants in the safety set with at least one measurable plasma concentration.|||hours||Full Range|Median
2593062|NCT02249793|Primary|Percentage of Total Metabolites|Percentage of metabolites displaying different abundances in biosamples collected during the morning hours versus evening hours. Analysis was performed for all participants as a group.|48 hours||||percent|||Number
2592893|NCT02252211|Secondary|Number of Patients With Human Anti-Human Antibody Positivity|Blood samples to detect human anti-human antibody (HAHA) formation were collected on Days 1 (pre-infusion [within 7 days of Day 1 dose] and post-infusion), 8, 22, 36 (pre-infusion), and 50 (anytime). For Cycle 2 onward, HAHA samples were collected on Day 1 (pre-infusion) and at the end of the study (anytime). HAHA samples were analyzed using ELISA and were categorized as either positive or negative for a HAHA response. HAHA positivity indicates that a patient has developed an antibody response.|Up to 43 Weeks|The Safety Analysis Set comprised all patients who received at least 1 infusion of DS-8895a.|||Participants|||Count of Participants
2592894|NCT02252211|Secondary|Number of Patients With Pharmacodynamic (Metabolic) Response|The pharmacodynamic (metabolic) response of DS-8895a was assessed by ^18F-FDG PET at Screening, Day 29, and Day 50. Tumor metabolism response was evaluated as the difference in standardized uptake values between the pre- and post-treatment FDG PET scans. The measurement of [18F]-FDG uptake for tumor metabolic response monitoring was performed according to the European Organization for Research and Treatment of Cancer (EORTC) PET response criteria (Young et al. Eur J Cancer 1999;35:1773-82).|Day 29 and Day 50|The Safety Analysis Set comprised all patients who received at least 1 infusion of DS-8895a.|||Participants|||Count of Participants
2592895|NCT02252211|Secondary|Mean Elimination Half-life of DS-8895a Following the First Infusion|The PK of DS-8895a was calculated based on data from enzyme-linked immunosorbent assay (ELISA) of serum samples. Serum samples for ELISA were drawn at the same times as for gamma counting with the addition of Day 8 (pre- and 0 to 30 minutes post-infusion), Day 9 (anytime), and Day 22 (pre- and 0 to 30 minutes post-infusion). For Cycle 2 onward, blood samples for PK were taken at pre- and 0 to 30 minutes post-infusion on Days 1, 15, and 29.|Cycle 1 Day 1 (pre-infusion and 5 minutes, 1, 2, and 4 hours post-infusion)|The PK Analysis Set comprised all patients who received at least 1 infusion of DS-8895a and had evaluable PK samples for a given analysis. One patient in the 1 mg/kg cohort did not have adequate samples to calculate PK parameters for this analysis.|||hr||Standard Deviation|Mean
2592896|NCT02252211|Secondary|Mean Maximum Serum Concentration of DS-8895a Following the First Infusion|The PK of DS-8895a was calculated based on data from enzyme-linked immunosorbent assay (ELISA) of serum samples. Serum samples for ELISA were drawn at the same times as for gamma counting with the addition of Day 8 (pre- and 0 to 30 minutes post-infusion), Day 9 (anytime), and Day 22 (pre- and 0 to 30 minutes post-infusion). For Cycle 2 onward, blood samples for PK were taken at pre- and 0 to 30 minutes post-infusion on Days 1, 15, and 29.|Cycle 1 Day 1 (pre-infusion and 5 minutes, 1, 2, and 4 hours post-infusion)|The PK Analysis Set comprised all patients who received at least 1 infusion of DS-8895a and had evaluable PK samples for a given analysis. One patient in the 1 mg/kg cohort did not have adequate samples to calculate PK parameters for this analysis.|||µg/mL||Standard Deviation|Mean
2592897|NCT02252211|Secondary|Mean Total Serum Clearance of DS-8895a Following the First Infusion|The PK of DS-8895a was calculated based on data from enzyme-linked immunosorbent assay (ELISA) of serum samples. Serum samples for ELISA were drawn at the same times as for gamma counting with the addition of Day 8 (pre- and 0 to 30 minutes post-infusion), Day 9 (anytime), and Day 22 (pre- and 0 to 30 minutes post-infusion). For Cycle 2 onward, blood samples for PK were taken at pre- and 0 to 30 minutes post-infusion on Days 1, 15, and 29.|Cycle 1 Day 1 (pre-infusion and 5 minutes, 1, 2, and 4 hours post-infusion)|The PK Analysis Set comprised all patients who received at least 1 infusion of DS-8895a and had evaluable PK samples for a given analysis. One patient in the 1 mg/kg cohort did not have adequate samples to calculate PK parameters for this analysis.|||mL/hr/kg||Standard Deviation|Mean
2592898|NCT02252211|Secondary|Mean Volume of Distribution at Steady State of DS-8895a Following the First Infusion|The PK of DS-8895a was calculated based on data from enzyme-linked immunosorbent assay (ELISA) of serum samples. Serum samples for ELISA were drawn at the same times as for gamma counting with the addition of Day 8 (pre- and 0 to 30 minutes post-infusion), Day 9 (anytime), and Day 22 (pre- and 0 to 30 minutes post-infusion). For Cycle 2 onward, blood samples for PK were taken at pre- and 0 to 30 minutes post-infusion on Days 1, 15, and 29.|Cycle 1 Day 1 (pre-infusion and 5 minutes, 1, 2, and 4 hours post-infusion)|The PK Analysis Set comprised all patients who received at least 1 infusion of DS-8895a and had evaluable PK samples for a given analysis. One patient in the 1 mg/kg cohort did not have adequate samples to calculate PK parameters for this analysis.|||mL/kg||Standard Deviation|Mean
2592899|NCT02252211|Secondary|Mean Area Under the Serum Concentration Curve of DS-8895a Following the First Infusion|The PK of DS-8895a was calculated based on data from enzyme-linked immunosorbent assay (ELISA) of serum samples. Serum samples for ELISA were drawn at the same times as for gamma counting with the addition of Day 8 (pre- and 0 to 30 minutes post-infusion), Day 9 (anytime), and Day 22 (pre- and 0 to 30 minutes post-infusion). For Cycle 2 onward, blood samples for PK were taken at pre- and 0 to 30 minutes post-infusion on Days 1, 15, and 29.|Cycle 1 Day 1 (pre-infusion and 5 minutes, 1, 2, and 4 hours post-infusion)|The PK Analysis Set comprised all patients who received at least 1 infusion of DS-8895a and had evaluable PK samples for a given analysis. One patient in the 1 mg/kg cohort did not have adequate samples to calculate PK parameters for this analysis.|||hr*μg/mL||Standard Deviation|Mean
2592900|NCT02252211|Secondary|Mean Elimination Half-life of ^89Zr-Df-DS-8895a Following the First Infusion|The PK of ^89Zr-Df-DS-8895a was calculated based on data from gamma counting of serum samples. Serum samples for gamma counting were drawn on Day 1 (pre-infusion and 5 minutes, 1, 2, and 4 hours post-infusion), Day 2 (24 hours post-infusion), Day 4/5 (anytime), Day 36 (pre-infusion, and 5 minutes, 1, 2, and 4 hours post infusion), Day 37 (24 hours post-infusion), Day 39/40 (anytime), Day 42/43 (anytime), and Day 50 (anytime). For Cycle 2 onward, blood samples for PK were taken at pre- and 0 to 30 minutes post-infusion on Days 1, 15, and 29.|Cycle 1 Day 1 (pre-infusion and 5 minutes, 1, 2, and 4 hours post-infusion)|The PK Analysis Set comprised all patients who received at least 1 infusion of DS-8895a and had evaluable PK samples for a given analysis.|||hr||Standard Deviation|Mean
2592919|NCT02252172|Secondary|Percentage of Participants With Very Good Partial Response (VGPR) or Better|VGPR or better is defined as the percentage of participants with a response of VGPR or better (VGPR, CR or sCR) based on computerized algorithm as per IMWG criteria. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. In participants with only measurable disease by serum FLC levels a >90% decrease in the difference between involved and uninvolved FLC levels is required.|From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)||2024-12-31|12/2024||||
2592901|NCT02252211|Secondary|Mean Maximum Serum Concentration of ^89Zr-Df-DS-8895a Following the First Infusion|The PK of ^89Zr-Df-DS-8895a was calculated based on data from gamma counting of serum samples. Serum samples for gamma counting were drawn on Day 1 (pre-infusion and 5 minutes, 1, 2, and 4 hours post-infusion), Day 2 (24 hours post-infusion), Day 4/5 (anytime), Day 36 (pre-infusion, and 5 minutes, 1, 2, and 4 hours post infusion), Day 37 (24 hours post-infusion), Day 39/40 (anytime), Day 42/43 (anytime), and Day 50 (anytime). For Cycle 2 onward, blood samples for PK were taken at pre- and 0 to 30 minutes post-infusion on Days 1, 15, and 29.|Cycle 1 Day 1 (pre-infusion and 5 minutes, 1, 2, and 4 hours post-infusion)|The PK Analysis Set comprised all patients who received at least 1 infusion of DS-8895a and had evaluable PK samples for a given analysis.|||µg/mL||Standard Deviation|Mean
2592902|NCT02252211|Secondary|Mean Total Serum Clearance of ^89Zr-Df-DS-8895a Following the First Infusion|The PK of ^89Zr-Df-DS-8895a was calculated based on data from gamma counting of serum samples. Serum samples for gamma counting were drawn on Day 1 (pre-infusion and 5 minutes, 1, 2, and 4 hours post-infusion), Day 2 (24 hours post-infusion), Day 4/5 (anytime), Day 36 (pre-infusion, and 5 minutes, 1, 2, and 4 hours post infusion), Day 37 (24 hours post-infusion), Day 39/40 (anytime), Day 42/43 (anytime), and Day 50 (anytime). For Cycle 2 onward, blood samples for PK were taken at pre- and 0 to 30 minutes post-infusion on Days 1, 15, and 29.|Cycle 1 Day 1 (pre-infusion and 5 minutes, 1, 2, and 4 hours post-infusion)|The PK Analysis Set comprised all patients who received at least 1 infusion of DS-8895a and had evaluable PK samples for a given analysis.|||mL/hr/kg||Standard Deviation|Mean
2592903|NCT02252211|Secondary|Mean Volume of Distribution at Steady State of ^89Zr-Df-DS-8895a Following the First Infusion|The PK of ^89Zr-Df-DS-8895a was calculated based on data from gamma counting of serum samples. Serum samples for gamma counting were drawn on Day 1 (pre-infusion and 5 minutes, 1, 2, and 4 hours post-infusion), Day 2 (24 hours post-infusion), Day 4/5 (anytime), Day 36 (pre-infusion, and 5 minutes, 1, 2, and 4 hours post infusion), Day 37 (24 hours post-infusion), Day 39/40 (anytime), Day 42/43 (anytime), and Day 50 (anytime). For Cycle 2 onward, blood samples for PK were taken at pre- and 0 to 30 minutes post-infusion on Days 1, 15, and 29.|Cycle 1 Day 1 (pre-infusion and 5 minutes, 1, 2, and 4 hours post-infusion)|The PK Analysis Set comprised all patients who received at least 1 infusion of DS-8895a and had evaluable PK samples for a given analysis.|||mL/kg||Standard Deviation|Mean
2592904|NCT02252211|Secondary|Mean Area Under the Serum Concentration Curve of ^89Zr-Df-DS-8895a Following the First Infusion|The pharmacokinetics (PK) of ^89Zr-Df-DS-8895a were calculated based on data from gamma counting of serum samples. Serum samples for gamma counting were drawn on Day 1 (pre-infusion and 5 minutes, 1, 2, and 4 hours post-infusion), Day 2 (24 hours post-infusion), Day 4/5 (anytime), Day 36 (pre-infusion, and 5 minutes, 1, 2, and 4 hours post infusion), Day 37 (24 hours post-infusion), Day 39/40 (anytime), Day 42/43 (anytime), and Day 50 (anytime). For Cycle 2 onward, blood samples for PK were taken at pre- and 0 to 30 minutes post-infusion on Days 1, 15, and 29.|Cycle 1 Day 1 (pre-infusion and 5 minutes, 1, 2, and 4 hours post-infusion)|The PK Analysis Set comprised all patients who received at least 1 infusion of DS-8895a and had evaluable PK samples for a given analysis.|||hr*μg/mL||Standard Deviation|Mean
2592905|NCT02252211|Secondary|Number of Patients With Best Overall Tumor Response|Tumor responses were evaluated using computed tomography and categorized according to the Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) at Screening (up to 21 days before the first dose of study drug), on Day 50, and approximately every 6 weeks thereafter for patients who received continued study dosing. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|Up to 58 weeks|The Evaluable Analysis Set comprised all patients who received at least 1 infusion of DS-8895a and completed all study procedures up to Day 50.|||Participants|||Count of Participants
2592906|NCT02252211|Secondary|Number of Patients With Tumor Uptake of ^89Zr-Df-DS-8895a|The biodistribution and tumor uptake of ^89Zr-Df-DS-8895a was determined based on qualitative analysis of whole body positron emission tomography (PET)/computed tomography (CT) images. PET imaging was performed following the ^89Zr-Df-DS-8895a infusions on Day 1 (Days 1, 4/5, and 7/8) and Day 36 (Days 36, 39/40 and 42/43). Qualitative parameters assessed included tumor uptake of reference lesions (scored on a 0-3 point scale: none, low, med, high). The reference lesions were initially identified on fluorodeoxyglucose (FDG) PET scans with a score of 3 for [18F]-fluorodeoxyglucose uptake. The summary table presents the maximum reference lesion ^89Zr-Df-DS-8895a uptake score reported for individual patients.|Up to Day 43|The Safety Analysis Set comprised all patients who received at least 1 infusion of DS-8895a.|||Participants|||Count of Participants
2592907|NCT02252211|Primary|Number of Patients With Treatment-emergent Adverse Events|Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period.|Continuously for up to 58 weeks|The Safety Analysis Set comprised all patients who received at least 1 infusion of DS-8895a.|||Participants|||Count of Participants
2592908|NCT02252172|Secondary|Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score to Day 1 of Cycle 3, 6, 9 and 12|EQ-5D-5L is standardized, participant-reported questionnaire to assess health-related quality of life. EQ-5D-5L includes 2 components: EQ-5D-5L health state profile (descriptive system) and EQ-5D-5L VAS. EQ-5D-5L descriptive system provides a profile of participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5-dimension scores were combined and converted into single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of individual (but allows for values less than 0 by United kingdom [UK] scoring algorithm).|Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)|ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable in this outcome measure. Here 'n' signifies number of participants analyzed at specified timepoints.|||Score on scale||95% Confidence Interval|Least Squares Mean
2592909|NCT02252172|Secondary|Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) to Day 1 of Cycle 3, 6, 9 and 12|EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.|Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)|ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable in this outcome measure. Here 'n' signifies number of participants analyzed at specified timepoints.|||Score on scale||95% Confidence Interval|Least Squares Mean
2592910|NCT02252172|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Global Health Status Score to Day 1 of Cycle 3, 6, 9 and 12|"EORTC QLQ-C30 is 30 items self-reporting questionnaire, with 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Questionnaire includes 28 items with 4-point Likert type responses from 1-not at all to 4-very much to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall health related QoL. Scores are transformed to 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values shows deterioration in quality of life or functioning and reduction in symptom and positive values indicate improvement and worsening of symptoms."|Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)|ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable in this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints.|||Score on scale||95% Confidence Interval|Least Squares Mean
2592911|NCT02252172|Secondary|Progression-free Survival on Next Line of Therapy (PFS2)|PFS2 is defined as the time from randomization to progression on the first line of subsequent anti-myeloma therapy or death, whichever occurs first. Disease progression on first line of subsequent anti-myeloma treatment was based on investigator judgment. Participants that were censored for PFS1 were also censored for PFS2.|From randomization to disease progression on first line of subsequent anti-myeloma therapy, death, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)||2024-12-31|12/2024||||
2592912|NCT02252172|Secondary|Time to Subsequent Anti-myeloma Treatment|Time to subsequent anti-myeloma treatment is defined as the time from randomization to the start of first line of subsequent anti-myeloma treatment or death, whichever occurs first.|From randomization to start of first subsequent anti-myeloma treatment, death, withdrawal of consent to study participation or CCO whichever is first (up to 7.8 years)||2024-12-31|12/2024||||
2592913|NCT02252172|Secondary|Duration of Response (DoR)|DoR is defined as the time from the date of initial response (PR or better) to the date of PD, based on computerized algorithm as per IMWG criteria.|From first response (PR of better) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)||2024-12-31|12/2024||||
2592914|NCT02252172|Secondary|Time to Response|Time to response is defined as the time from the date of randomization to the first efficacy evaluation that met criteria for PR or better based on computerized algorithm as per IMWG criteria. PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours. If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow PCs is required. A >=50% reduction in the size of soft tissue plasmacytomas is also required.|From randomization to first response (PR or better) (up to 7.8 years)||2024-12-31|12/2024||||
2592915|NCT02252172|Secondary|Time to Disease Progression (TTP)|TTP is defined as the time from the date of randomization to the date of PD based on computerized algorithm as per IMWG criteria, or death due to PD.|From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)||2024-12-31|12/2024||||
2592916|NCT02252172|Secondary|Overall Survival (OS)|OS was measured from the date of randomization to the date of the death.|From randomization to death, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)||2024-12-31|12/2024||||
2592917|NCT02252172|Secondary|Overall Response Rate (ORR)|ORR is defined as the percentage of participants who achieved partial response (PR) or better (PR, VGPR, CR or sCR) based on computerized algorithm as per IMWG criteria. PR is defined as >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours. If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required. A >=50% reduction in the size of soft tissue plasmacytomas is also required.|From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)||2024-12-31|12/2024||||
2592918|NCT02252172|Secondary|Percentage of Participants With Negative Minimal Residual Disease (MRD)|MRD negativity rate is defined as the percentage of participants who had negative MRD (detection of less than 1 malignant cell among 100,000 normal cells) assessment at any timepoint after the date of randomization by evaluation of bone marrow aspirates. MRD was assessed in participants who achieved CR or better.|From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)||2024-12-31|12/2024||||
2592957|NCT02251938|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 in the Study Eye|Best Corrected Visual Acuity (BCVA) measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters. An increase in BCVA indicates improvement in the best-corrected vision. A BCVA score of 85 ETDRS letters is equivalent to 20/20 vision, which is considered normal vision.|Day 1 (Baseline) and Month 12 or early termination visit||||ETDRS Letters||Standard Deviation|Mean
2592920|NCT02252172|Secondary|Percentage of Participants With Complete Response (CR) or Better|CR or better is defined as percentage of participants with a CR or better (CR or stringent complete response [sCR]) based on computerized algorithm as per IMWG criteria. CR is defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (<) 5 percent (%) PCs in bone marrow. In participants with only measurable disease by serum FLC levels a normal serum FLC ratio is required. sCR is defined as in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry.|From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)||2024-12-31|12/2024||||
2592921|NCT02252172|Primary|Primary: Progression-free Survival (PFS)|PFS is defined as time from date of randomization to either progressive disease (PD) or death, whichever occurs first based on computerized algorithm as per International Myeloma Working Group (IMWG) criteria. PD is defined as an increase of 25 percent (%) from the lowest response value in one of the following: serum and urine M-component (absolute increase must be greater than or equal to [>=] 0.5 gram per deciliter [g/dL] and >=200 milligram [mg]/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be greater than [>]10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to Plasma cell (PC) proliferative disorder.|From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 3.5 years)|Intent-to-treat (ITT) population included all randomized participants.|||Months||95% Confidence Interval|Median
2592922|NCT02252146|Primary|Number of Participants With Adverse Events, Injection Site Reactions, and Concomitant Medications|Frequency of adverse events, injection site reactions, and concomitant medications observed|Up to 2 years from first patient visit|Safety population|||Participants|||Count of Participants
2592923|NCT02252133|Primary|Success Rate of Lens Centration After 7 ± 2 Days of Wear|"Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as optimal or slight decentration. One eye (study eye) was analyzed."|Day 7, each product|This analysis population includes all subjects who used the study lenses and who met all inclusion criteria and did not meet any exclusion criteria.|||percentage of subjects|||Number
2592924|NCT02252042|Secondary|Number of Participants Who Discontinued Study Treatment Due to an AE in Participants With PD-L1 ≥1% CPS|The number of all participants with PD-L1 ≥1% CPS who discontinued study treatment due to an AE is presented.|Up to approximately 2 years|The safety population consisted of all randomized participants with PD-L1 ≥1% CPS who received at least one dose of study treatment.|||Participants|||Count of Participants
2592925|NCT02252042|Secondary|Number of Participants Who Discontinued Study Treatment Due to an AE in All Participants|The number of all participants who discontinued study treatment due to an AE is presented.|Up to approximately 2 years|The safety population consisted of all randomized participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2592926|NCT02252042|Secondary|Number of Participants Who Experienced At Least One AE in Participants With PD-L1 ≥1% CPS|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of all participants with PD-L1 ≥1% CPS who experienced at least one AE is presented.|Up to approximately 27 months|The safety population consisted of all randomized participants with PD-L1 ≥1% CPS who received at least one dose of study treatment.|||Participants|||Count of Participants
2592927|NCT02252042|Secondary|Number of Participants Who Experienced At Least One Adverse Event (AE) in All Participants|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of all participants who experienced at least one AE is presented.|Up to approximately 27 months|The safety population consisted of all randomized participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2592928|NCT02252042|Secondary|PFS Per Modified RECIST 1.1 in Participants With PD-L1 ≥1% CPS|PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. Modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (>4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1. The PFS per modified RECIST for all participants with PD-L1 ≥1% CPS is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants with PD-L1 ≥1% CPS. Participants are included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2593063|NCT02249793|Primary|Changes Over Time in Ambulatory Blood Pressure - Systolic Blood Pressure|Ambulatory blood pressure monitoring|48 hours||||mmHg||Standard Deviation|Mean
2592929|NCT02252042|Secondary|PFS Per Modified RECIST in All Participants|PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. Modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (>4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1. The PFS per modified RECIST for all participants is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants. Participants are included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2592930|NCT02252042|Secondary|TTP Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS|TTP was defined as the time from randomization to the first documented disease progression based on assessments by the blinded central imaging vendor review per RECIST 1.1. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. The TTP per RECIST 1.1 for all participants with PD-L1 ≥1% CPS is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants with PD-L1 ≥1% CPS. Participants are included in the treatment group to which they were randomized.|||Months||Full Range|Median
2592931|NCT02252042|Secondary|Time to Progression (TTP) Per RECIST 1.1 in All Participants|TTP was defined as the time from randomization to the first documented disease progression based on assessments by the blinded central imaging vendor review per RECIST 1.1. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. The TTP per RECIST 1.1 for all participants is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants. Participants are included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2592932|NCT02252042|Secondary|DOR Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS|For participants who demonstrated a confirmed CR or PR per RECIST 1.1, DOR was defined as the time from first documented evidence of a confirmed CR or PR per RECIST 1.1 until disease progression per RECIST 1.1 or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. DOR assessments were based on blinded central imaging vendor review with confirmation. The DOR per RECIST 1.1 for all participants with PD-L1 ≥1% CPS who experienced a confirmed CR or PR is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants with PD-L1 ≥1% CPS who demonstrated a confirmed CR or PR per RECIST 1.1. Participants are included in the treatment group to which they were randomized.|||Months||Full Range|Median
2592933|NCT02252042|Secondary|Duration of Response (DOR) Per RECIST 1.1 in All Participants|For participants who demonstrated a confirmed CR or PR per RECIST 1.1, DOR was defined as the time from first documented evidence of a confirmed CR or PR per RECIST 1.1 until disease progression per RECIST 1.1 or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. DOR assessments were based on blinded central imaging vendor review with confirmation. The DOR per RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants who demonstrated a confirmed CR or PR per RECIST 1.1. Participants are included in the treatment group to which they were randomized.|||Months||Full Range|Median
2592934|NCT02252042|Secondary|ORR Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS|ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1 based on blinded central imaging vendor review with or without confirmation. The ORR per RECIST 1.1 for all participants with PD-L1 expression ≥1% CPS is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants with PD-L1 ≥1% CPS. Participants are included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
2592935|NCT02252042|Secondary|Objective Response Rate (ORR) Per RECIST 1.1 in All Participants|ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based on blinded central imaging vendor review with or without confirmation. The ORR per RECIST 1.1 for all participants is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants. Participants are included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
2592936|NCT02252042|Secondary|PFS Per RECIST 1.1 in Participants With PD-L1 ≥1% CPS|PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. The PFS per RECIST 1.1 for all participants with PD-L1 expression ≥1% CPS is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants with PD-L1 ≥1% CPS. Participants are included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2592937|NCT02252042|Secondary|Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 for All Participants|PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression. The PFS per RECIST 1.1 for all participants is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants. Participants are included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2592938|NCT02252042|Secondary|OS for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Expression Defined by ≥1% Combined Positive Score (CPS)(PD-L1 ≥1% CPS)|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis will be censored at the date of the last follow-up. The OS for all participants with PD-L1 expression ≥1% CPS is presented. These efficacy results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years|The efficacy population consisted of all randomized participants with PD-L1 ≥1% CPS. Participants are included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2592939|NCT02252042|Primary|Updated Final OS for All Participants|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. The updated OS for all participants is presented. These OS results are after complete acquisition of all outstanding survival data using a 15-May-2017 data cutoff date with a database update date of 13-Oct-2017.|Up to approximately 2 years (Database update on 13-Oct-2017)|The efficacy population consisted of all randomized participants. Participants are included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2592940|NCT02252042|Primary|Initial Overall Survival (OS) for All Participants|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. The OS for all participants is presented. These initial OS results are based on a data cutoff date of 15-May-2017 with a database lock date of 04-Jun-2017. At the time of the database lock of 04-Jun-2017, there was incomplete collection of survival data for 12 participants.|Up to approximately 2 years (Database lock on 04-Jun-2017)|The efficacy population consisted of all randomized participants. Participants are included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2592941|NCT02252016|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)|The percentage of participants in both arms achieving SVR24 (i.e., HCV RNA level below the LLoQ 24 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL.|24 weeks after completing study therapy (Week 36)|The FAS consists of all treated participants in both arms other than those who discontinued with reasons unrelated to the treatment regimen or HCV response.|||Percentage of participants||95% Confidence Interval|Number
2592942|NCT02252016|Primary|Percentage of Participants Discontinuing From Study Treatment Due to an AE(s)|An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.|Up to Week 12|The APaT population includes all participants receiving ≥1 dose(s) of study drug. For the Deferred Treatment arm, data indicate results obtained during the initial 12-week placebo treatment period.|||Percentage of Participants|||Number
2592943|NCT02252016|Primary|Percentage of Participants Experiencing an Adverse Event (AE)|An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.|Up to Week 14|The All-Participants-as-Treated (APaT) population includes all participants receiving ≥1 dose(s) of study drug. For the Deferred Treatment arm, data indicate results obtained during the initial 12-week placebo treatment period.|||Percentage of Participants|||Number
2592944|NCT02252016|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)|The percentage of participants in the both arms achieving SVR12 (i.e., HCV riboncleic acid [RNA] level below the lower limit of quantification [LLoQ] 12 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of <15 IU/mL.|12 weeks after completing study therapy (Week 24)|The Full Analysis Set (FAS) consists of all treated participants in both arms other than those who discontinued with reasons unrelated to the treatment regimen or HCV response.|||Percentage of participants||95% Confidence Interval|Number
2592958|NCT02251912|Secondary|Alcohol Craving|Mean weekly Penn Alcohol Craving Scale (PACS) scores.The PACS is a five-item self-administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking as well as the ability to resist drinking. Scores range from: Minimum: 0 Maximum: 30 Lower scores are associated with better outcomes.|12 weeks||||units on a scale||Standard Error|Least Squares Mean
2593064|NCT02249793|Primary|Calls and Text Messages|Aggregate communication as behavioral features has been collected using the cell phone data streams.|3-4 months||||Calls and text messages||Full Range|Mean
2592945|NCT02251990|Other Pre-specified|Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After the End of All Study Therapy (SVR4)|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a LLOQ of 15 IU/mL. SVR4 was defined as HCV RNA <LLOQ at 4 weeks after the end of all study therapy. As pre-specified in the protocol, the Deferred Treatment Group was not included in this efficacy analysis.|4 weeks after end of all therapy (Study Week 16)|All randomized participants in the Immediate Treatment Group who received at least one dose of study treatment. The Deferred Treatment Group was not included in this efficacy analysis.|||percentage of participants||95% Confidence Interval|Number
2592946|NCT02251990|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a LLOQ of 15 IU/mL. SVR24 was defined as HCV RNA <LLOQ at 24 weeks after the end of all study therapy. As pre-specified in the protocol, the Deferred Treatment Group was not included in the secondary efficacy analysis.|24 weeks after end of all therapy (Study Week 36)|All randomized participants in the Immediate Treatment Group who received at least one dose of study treatment. The Deferred Treatment Group was not included in the secondary efficacy analysis.|||percentage of participants||95% Confidence Interval|Number
2592947|NCT02251990|Primary|Percentage of Participants That Discontinued From Study Therapy Due to AEs During the DB Treatment Period|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE. A participant could discontinue from treatment but continue to participate in the study as long as consent was not withdrawn. The primary safety analysis compared the safety data of the Immediate Treatment Group during the active treatment period to those of the Deferred Treatment Group during the placebo treatment period.|DB Treatment period (up to 12 weeks)|All randomized participants who received at least one dose of study treatment during the double-blind treatment period.|||percentage of participants|||Number
2592948|NCT02251990|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) During the DB Treatment Period and First 14 Follow-up Days|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE. The primary safety analysis compared the safety data of the Immediate Treatment Group during the active treatment period to those of the Deferred Treatment Group during the placebo treatment period.|DB Treatment period plus first 14 follow-up days (up to 14 weeks)|All randomized participants who received at least one dose of study treatment during the double-blind treatment period.|||percentage of participants|||Number
2592949|NCT02251990|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a lower limit of quantification (LLOQ) of 15 IU/mL. SVR12 was defined as HCV RNA below the lower limit of detection (<LLOQ) at 12 weeks after the end of all study therapy. As pre-specified in the protocol, the Deferred Treatment Group was not included in the primary efficacy analysis.|12 weeks after end of all therapy (Study Week 24)|All randomized participants in the Immediate Treatment Group who received at least one dose of study treatment. The Deferred Treatment Group was not included in the primary efficacy analysis.|||percentage of participants||97.5% Confidence Interval|Number
2592950|NCT02251938|Primary|Number of Subjects With a Shift in Retina Status at Month 12 in the Study Eye.|Ophthalmoscopy findings were reported as normal or abnormal.|Day 1 (Baseline) and Month 12 or early termination visit||||Subjects|||Number
2592951|NCT02251938|Primary|Number of Subjects With a Shift in Optic Nerve Status at Month 12 in the Study Eye.|Ophthalmoscopy findings were reported as normal or abnormal.|Day 1 (Baseline) and Month 12 or early termination visit||||Subjects|||Number
2592952|NCT02251938|Primary|Number of Subjects With a Shift in Macula Status at Month 12 in the Study Eye.|Ophthalmoscopy findings were reported as normal or abnormal.|Day 1 (Baseline) and Month 12 or early termination visit||||Subjects|||Number
2592953|NCT02251938|Primary|Number of Subjects Who Receive Rescue Therapy.|Rescue therapy was defined as any treatment that would have a therapeutic effect on the uveitis in the posterior segment (e.g., systemic treatment with an immunosuppressant agent, or a corticosteroid injection in the study eye) other than intravitreal DE-109 determined by the Investigator.|By Month12||||Participants|||Count of Participants
2592954|NCT02251938|Primary|Changes From Baseline in Vitreous Haze (VH) Scores at Month 12|"Vitreous Haze (VH) scores were measured using the modified Standardized Uveitis Nomenclature Photographic Scale (SUN) :~0 No inflammation~0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)~Mild blurring of the retinal vessels and optic nerve~1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+~Moderate blurring of the optic nerve head~Marked blurring of the optic nerve head~Optic Nerve head not visible"|Day 1 (Baseline) and Month 12 or early termination visit||||score on a scale||Standard Deviation|Mean
2592955|NCT02251938|Primary|Number of Subjects With a Shift in Choroid Status at Month 12 in the Study Eye.|Ophthalmoscopy findings were reported as normal or abnormal.|Day 1 (Baseline) and Month 12 or early termination visit||||Subjects|||Number
2592956|NCT02251938|Primary|Mean Change From Baseline in Intraocular Pressure at Month 12 in the Study Eye|Intraocular pressure (IOP), the fluid pressure inside the eye, was measured by applanation tonometry in millimeters mercury (mmHg) with one decimal point.|Day 1 (Baseline) and Month 12 or early termination visit||||mmHg||Standard Deviation|Mean
2594355|NCT02233738|Secondary|Quality of Life Survey (QOLS) at 3 Months|Min value:16 Max value:112 Higher score indicates higher quality of life|3 months||||score on a scale||Standard Deviation|Mean
2592962|NCT02251717|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug|||percentage of participants|||Number
2592963|NCT02251717|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2592964|NCT02251717|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who received at least 1 dose of study drug|||percentage of participants|||Number
2592965|NCT02251717|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2592966|NCT02251652|Secondary|Change in Actinic Keratoses by Anatomic Site|To evaluate the number of AKs (both hypertrophic and non-hypertrophic) before therapy by anatomic site (dorsal hand) at Day 57 as compared to baseline|Baseline and Day 57|Comparisons of proportion of responders between treated and control hands|||percent change|Actinic Keratoses lesions|Standard Deviation|Mean
2592967|NCT02251652|Secondary|Change in Number of All Actinic Keratoses|To evaluate and compare the mean reduction in number of all AKs (hypertrophic and non-hypertrophic) on the dorsal hands of the combination cryotherapy- ingenol mebutate treated side vs. the cryotherapy alone side on Day 57 as compared to baseline|Baseline and Day 57|Comparisons of proportion of responders between treated and control hands|||percent change|Actinic Keratoses lesions|Standard Deviation|Mean
2592968|NCT02251652|Primary|Safety of Combination Therapy vs Cryotherapy Alone|To evaluate the safety of cryotherapy plus ingenol mebutate on dorsal hands and compare it to the safety of cryotherapy alone looking at Adverse Events.|Day 57||||Participants|||Count of Participants
2592969|NCT02251613|Secondary|Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1|A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Conjunctival hyperemia (redness) was evaluated by the investigator based on biomicroscopy for each eye at 20 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=extremely severe).|Day 1, 20 minutes post-CAC|This analysis population includes all randomized participants.|||units on a scale|Participants|Standard Deviation|Mean
2592970|NCT02251613|Primary|Mean Ocular Itching at 7 Minutes Post-CAC, Day 1|A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub).|Day 1, 7 minutes post-CAC|This analysis population includes all randomized participants.|||units on a scale|Participants|Standard Deviation|Mean
2592971|NCT02251561|Secondary|Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein|The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale [0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)]. Proportion of participants is reported as a percentage.|Day 1, after 2 hours of wear|This analysis population includes all subjects who used the study products and had examination/observation data after use.|||percentage of participants|||Number
2592972|NCT02251561|Primary|Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein|The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage.|Day 1, after 2 hours of wear|This analysis population includes all subjects who used the study products and had examination/observation data after use.|||percentage of participants|||Number
2592973|NCT02251379|Secondary|FEV1/FVC|Forced expiratory volume at one second/forced vital capacity (FEV1/FVC) will be evaluated as a continuous variable. This is a ratio without any units.|6 months|participants completing the 6 month follow-up visit|||ratio||Standard Deviation|Mean
2592974|NCT02251379|Secondary|Number of Asthma Exacerbations|Asthma exacerbations will be assessed by number of acute visits to the emergency department (ED), hospitalizations and urgent doctor visits.|6 months|participants completing the 6 month follow-up visit|||acute visits|||Number
2592975|NCT02251379|Secondary|Number of Asthma Symptom Days|Number of asthma symptom days in the past two weeks will be a measure of asthma control.|6 months|participants who completed the final follow-up visit at 6 months.|||days||Standard Deviation|Mean
2592976|NCT02251379|Secondary|Exhaled Nitric Oxide|Exhaled nitric oxide in parts per billion.|6 months|participants completing the final follow-up visit at 6 months with valid exhaled nitric oxide measurement. Not all participants had valid measures.|||parts per billion||Inter-Quartile Range|Median
2592977|NCT02251379|Secondary|Daily Inhaled Corticosteroid Dose|micrograms of inhaled corticosteroids (daily)|6 months|participants who completed the final follow-up visit at 6 months|||micrograms/day||Standard Deviation|Mean
2592978|NCT02251379|Primary|The Medication Treatment Step Assigned|The controller medication treatment step that was assigned at the visit, which is based on the current controller medication treatment step and the current level of asthma control. The range is from 0-6, with 0 indicating no controller medication and 6 indicating high dose inhaled corticosteroids plus long-acting beta agonist.|6 month clinic visit|participants completing the final 6 month follow-up visit|||score on a scale||Standard Deviation|Mean
2592979|NCT02251275|Primary|Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was as any untoward medical occurrence associated with the use of an investigational medicinal product (IMP), whether or not considered IMP related. A TEAE was an AE that started after trial drug treatment; or if the event was continuous from baseline and was serious, related to IMP, or resulted in death, discontinuation, interruption or reduction of trial therapy. A serious TEAE included any event that resulted in: death, life-threatening, persistent or significant incapacity, substantial disruption of ability to conduct normal life functions, required inpatient hospitalization, prolonged hospitalization, congenital anomaly/birth defect, or other medically significant events as per medical judgment, that jeopardized the participant and that required medical or surgical intervention. A severe TEAE was an inability to work or perform normal daily activity. A summary of serious and all other non-serious TEAEs, regardless of causality, is located in the AE section.|Baseline through end of treatment (up to 42 months) and follow-up 7 days posttreatment(+ 7 days)|All participants who received at least 1 dose of study drug.|||participants|||Number
2592980|NCT02251236|Primary|Concentration of Tenofovir in Cerebrospinal Fluid at Week 24||Week 24|No participants enrolled in the Untreated Arm|||ng/mL||Full Range|Median
2592981|NCT02251236|Primary|Concentration of Tenofovir in Cerebrospinal Fluid at Baseline||Baseline|No participants enrolled in the Untreated Arm|||ng/mL||Full Range|Median
2592982|NCT02251236|Primary|Concentration of Elvitegravir in Cerebrospinal Fluid at Week 24||Week 24|No participants enrolled in the Untreated Arm|||ng/mL||Full Range|Median
2592983|NCT02251236|Primary|Concentration of Elvitegravir in Cerebrospinal Fluid at Baseline||Baseline|No participants enrolled in the Untreated Arm|||ng/mL||Full Range|Median
2592984|NCT02250807|Secondary|Percentage of Participants With Viral Relapse|Participants were considered to have viral relapse if they did not achieve SVR12 and meet the following conditions: 1) at EOT, HCV RNA less than (<)LLOQ, undetectable, and 2) during the follow-up period, HCV RNA greater than or equal to (>=)LLOQ.|Up to follow-up week 24|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).|||percentage of participants|||Number
2592985|NCT02250807|Secondary|Percentage of Participants With Viral Breakthrough|Participants with confirmed >1.0 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA <LLOQ.|Up to follow-up Week 24|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).|||percentage of participants|||Number
2592986|NCT02250807|Secondary|Percentage of Participants With On-Treatment Failure|Participants were considered on-treatment failures if they have at EOT (confirmed) detectable HCV RNA, i.e., <LLOQ detectable or >=LLOQ.|through 12 weeks (EOT)|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).|||percentage of participants|||Number
2592987|NCT02250807|Secondary|Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|Percentage of participants with HCV RNA less than (<) 15 IU/mL undetectable or detectable or detectable /undetectable at specific time points were observed.|Week 2, 3, 4, 12 and EOT|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).|||percentage of participants|||Number
2592988|NCT02250807|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Therapy (SVR24)|Participants were considered to have reached SVR24, if at the time point of SVR24 (that is [i.e.], 24 weeks after the end of treatment [EOT]) the following condition has been met: HCV RNA < lower limit of quantification (LLOQ), i.e., 15 IU/mL, detectable or undetectable.|At 24 weeks after EOT|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).|||percentage of participants||95% Confidence Interval|Number
2592989|NCT02250807|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Therapy (SVR4)|SVR4 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 4 weeks after actual EOT.|4 weeks after EOT|ITT population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).|||percentage of participants||95% Confidence Interval|Number
2592990|NCT02250807|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)|SVR12 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 12 weeks after actual EOT.|12 weeks after EOT|Intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study medication (SMV and/or SOF).|||percentage of participants||95% Confidence Interval|Number
2592991|NCT02250703|Secondary|Presence of Amnesia to Mask Induction|Yes or No (if the patient remembers mask induction)|Day 0: at the time of discharge of the patient from the recovery room|7 patients in the M group and 5 patients in D group had significant developmental delay and could not answer the question regarding memory of mask induction. Thus, only 61 were analyzed for this part|||Participants|||Count of Participants
2592992|NCT02250703|Secondary|Wake up Behavior|"assessed in post anesthesia recovery unit after the procedure on a scale of 1o 4~calm~not calm but easily calmed~moderately agitated or restless~combative/disoriented 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory"|Day 0: At the end of surgery when the patient recovers from anesthesia||||Participants|||Count of Participants
2592993|NCT02250703|Secondary|Acceptance of Mask Induction|"on a scale of 1 to 4~excellent( cooperative)~good( slight fear, easily calmed)~fair ( moderate fear, not calmed with reassurance)~Poor( agitated, terrified) 1 and 2 are considered satisfactory 3 and 4 are considered unsatisfactory"|Day 0: At the time when anesthesia is induced||||Participants|||Count of Participants
2592994|NCT02250703|Primary|University of Michigan Sedation Scale|"Level of sedation at separation from parents and at the time of mask induction will be measured on a scale of 0 to 4 (University of Michigan Sedation Scale)~University of Michigan Sedation Scale:~0 -Awake/Alert~1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds.~2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation.~3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation.~4 - Unarousable~Moderately and Deeply sedated: Satisfactory Awake, minimally sedate, unarousable: Unsatisfactory"|Day 0:Just before the patient will be brought to the operating room||||Participants|||Count of Participants
2592995|NCT02250521|Secondary|Subjective Ease of Intubation|"The anesthesiologists rated the McGRATH™ MAC's ability in managing airways as very easy, easy, slight resistance, difficult, or not possible. The difficulty of endotracheal tube (ETT) delivery (that is, intubation) was evaluated during the insertion of the ETT into the patient's mouth, until the ETT passed the vocal cords."|at the time of laryngoscopy|Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.|||Participants|||Count of Participants
2592996|NCT02250521|Secondary|Subjective Ease of Laryngoscopy|"The anesthesiologists rated the McGRATH™ MAC's ability in managing airways as very easy, easy, slight resistance, difficult, or not possible. The difficulty of laryngoscopy was evaluated during the insertion and placement of the McGRATH™ MAC, from the patient's lips, into their oropharynx, until a glottic view was obtained."|at the time of laryngoscopy|Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.|||Participants|||Count of Participants
2592997|NCT02250521|Secondary|Number of Participants on Whom Bougie (Introducer) Was Used to Facilitate Intubation on the First Attempt||at the time of intubation|Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.|||Participants|||Count of Participants
2592998|NCT02250521|Secondary|Number of Participants Who Received External Laryngeal Manipulation During the First Attempt||at the time of intubation|Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.|||Participants|||Count of Participants
2592999|NCT02250521|Secondary|Number of Intubation Attempts||at the time of intubation|Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.|||Participants|||Count of Participants
2593000|NCT02250521|Secondary|Time for Intubation|Time for laryngoscopy (either direct or indirect) plus the time for endotracheal tube (ETT) cuff to pass vocal cords.|at the time of laryngoscopy|Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.|||seconds||Standard Deviation|Mean
2593001|NCT02250521|Secondary|Time for Indirect View Laryngoscopy During the First Attempt|Time from mouth opening to best indirect laryngoscopic view|at the time of laryngoscopy|Of the 100 patients recruited, 6 patients were excluded from data analysis, as describe in Outcome Measure 1's Analysis Population Description. 16 of the 94 analyzed had direct laryngoscopy, and thus 16 are analyzed in this outcome measure.|||seconds||Standard Deviation|Mean
2593002|NCT02250521|Secondary|Time for Direct View Laryngoscopy During the First Attempt|Time from mouth opening to best direct laryngoscopic view|at the time of laryngoscopy|Of the 100 patients recruited, 6 patients were excluded from data analysis, as describe in Outcome Measure 1's Analysis Population Description. 78 of the 94 analyzed had direct laryngoscopy, and thus 78 are analyzed in this outcome measure.|||seconds||Standard Deviation|Mean
2593003|NCT02250521|Secondary|Glottic View With Indirect Laryngoscopy|Glottic view as described by Cormack and Lehane (Samsoon GL, Young JR. Difficult tracheal intubation: A retrospective study. Anesthesia 1987; 42:487), scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible|at the time of laryngoscopy|Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.|||Participants|||Count of Participants
2593004|NCT02250521|Secondary|Glottic View With Direct Laryngoscopy|Glottic view as described by Cormack and Lehane, scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible|at the time of laryngoscopy|Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.|||Participants|||Count of Participants
2593005|NCT02250521|Primary|Number of Participants Successfully Intubated on First Attempt With Use of Either a Direct or Indirect Laryngoscopic View|All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist.|after successful endotracheal tube placement|Of the 100 patients recruited, 6 patients were excluded from data analysis. 4 patients were found to not meet inclusion criteria. One patient with glottic view grade 3 was erroneously intubated via the indirect method. For another patient, the anesthesiologist aborted the protocol due to encountered difficulties.|||Participants|||Count of Participants
2593006|NCT02250443|Secondary|Time to Reach the Maximum Concentration After Drug Administration (Tmax)|The time to reach the maximum concentration after drug administration|Day 1|Pharmacokinetics (PK) Analysis set: Patients with available PK data and no protocol deviations with relevant impact on PK data|||hr||Full Range|Median
2593007|NCT02250443|Secondary|Pharmacokinetics (PK) Parameter of Cmax|To obtain pharmacokinetic data from multiple i.v. dosing of BYM338 in this patient population. Pre-dose, 30 mins & 4 hours post-dose on Day 1.|Day 1|Pharmacokinetics (PK) Analysis set: Patients with available PK data and no protocol deviations with relevant impact on PK data|||ug/mL||Standard Deviation|Mean
2593008|NCT02250443|Secondary|Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan|Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was equal or more than 2% at Week 8 and 16 were considered responders|Baseline, Day 1, 57, 113|Pharmacodynamics (PD) analysis set: Patients with available PD data and no protocol deviations with relevant impact on PD data|||Percentage Change||Standard Deviation|Mean
2593009|NCT02250443|Secondary|Changes From Baseline in Muscle Function 6 Minute Walking Distance|The effect of BYM338 on additional muscle function measures (6 minute walking distance). The 6MWD test measured the distance (in meters) that a participant walked in a 6 minute timeframe. A positive change from baseline indicates improvement.|Baseline,Day 1, 113, 169, 365, 533, 729|Pharmacodynamics (PD) analysis set: Patients with available PD data and no protocol deviations with relevant impact on PD data|||Meters||Standard Deviation|Mean
2593010|NCT02250443|Secondary|Changes From Baseline in Muscle Function (Hand-grip and Pinch-grip Dynamometry)|The effect of BYM338 on additional muscle function measures (hand-grip and pinch-grip dynamometry).|Baseline,Day 1, 113, 169, 365, 533, 729|Pharmacodynamics (PD) analysis set: Patients with available PD data and no protocol deviations with relevant impact on PD data|||Newtons||Standard Deviation|Mean
2593011|NCT02250443|Secondary|Changes From Baseline in Muscle Strength.|Quadriceps muscle strength was measured, Quadriceps Quantitative Muscle Testing (QMT) by portable fixed dynamometry (PFD). A negative change from baseline indicates deterioration|Baseline, Day 1, 113, 169, 365, 533, 729|Pharmacodynamics (PD) analysis set: Patients with available PD data and no protocol deviations with relevant impact on PD data|||Newtons||Standard Deviation|Mean
2593012|NCT02250443|Secondary|Changes From Baseline in Physical Function Reported by Patients|Self-reported physical function was assessed by a newly developed patient reported outcome named sporadic inclusion body myositis (sIBM) functional assessment (sIFA). The sIFA consists of 11 items scored on an 11 point numerical rating scale from 0 (no difficulty) to 10 (unable to do) across 3 domains: upper body functioning, lower body functioning and general functioning. Participants completed the assessment where the recall period was the past week prior to completing the patient reported outcome (PRO). The total score on the sIFA scale ranges from 0 (minimum) to 110 (maximum). Higher values represent a worse outcome. A positive change from baseline indicates deterioration. Due to the no-signal this analysis was cancelled.|Baseline, Week 104|Due to the early study termination and the small sample size in this open-label trial, this PRO analysis was cancelled.||||||
2593013|NCT02250443|Secondary|Pharmacokinetics (PK) Parameter of Cmin From Multiple i.v. Dosing|To obtain pharmacokinetic data from multiple i.v. dosing of BYM338 in this patient population. Pre-dose, 30 mins & 4 hours post-dose on Day 1. Pre-dose only on each subsequent administration|Day 29, 85, 169, 253, 337, 421, 505, 589, 673, 757, 1177|Pharmacokinetics (PK) Analysis set: Patients with available PK data and no protocol deviations with relevant impact on PK data|||ng/mL||Standard Deviation|Mean
2593014|NCT02250443|Secondary|Changes From Baseline in Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA)|To assess the effect of multiple doses of BYM338 on lean body mass as measured by DXA in terms of change from baseline.|Baseline, Day 1, 57, 113, 169, 365, 533, and day 729|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data|||Percentage Change in LBM||Standard Deviation|Mean
2593015|NCT02250443|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity|Up to 29 month|safety analysis set - included all patients that received at least one dose of study drug. No statistical analysis provided for Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During this extension study|||Participants|||Number
2593016|NCT02250417|Secondary|Sleep Efficiency|Sleep quality assessment using objective sleep architecture measures during PSG performed during the non-Wave Sleep Surface night compared to the Wave Sleep Surface night during visits 2 and 3. Sleep efficiency is defined as the total sleep time divided by the total recording time X100.|measured during each of the two sleep study sessions (Study Visits 2 and 3)|Intention to treat analysis includes data from non-wave night regardless of time spent in supine position compared to baseline polysomnography.|||percentage of total recording time||Standard Deviation|Mean
2593017|NCT02250417|Post-Hoc|Apnea-hypopnea Index (AHI)- Modified Analysis|"AHI, or the apnea-hypopnea index, is a numerical measure that accounts for the number of pauses in breathing per hour of sleep.~These breathing disturbances are typically associated with either a brief arousal or awakening from sleep or a 4 percent drop in the blood oxygen levels, called a desaturation. It is used to assess the severity of an individual's sleep apnea.~This is measured in each study participant when sleeping with the Wave Sleep Surface and sleeping without the Wave Sleep Surface.~The modified analysis compares the AHI within each participant where time spent in the supine position is greater than time spent in non-supine position from either the baseline (inclusion) sleep study or the non-Wave night sleep study compared to the Wave Sleep Surface night sleep study."|Baseline (inclusion) sleep study or the non-Wave night sleep study compared to the Wave Sleep Surface night sleep study.|Modified analysis compares the AHI when the time spent in supine position is greater than in the non-supine position either during the baseline sleep study or the non-Wave night.The baseline PSG is the clinical PSG that was the basis of the inclusion to the study performed prior to randomization.|||events/hr||Standard Deviation|Mean
2593018|NCT02250417|Secondary|Objective Sleep Quality|Sleep quality assessment using objective sleep architecture measures during PSG performed during the non-Wave Sleep Surface night compared to the Wave Sleep Surface night during visits 2 and 3.|measured during each of the two sleep study sessions (Study Visits 2 and 3)|Intention to treat analysis includes data from non-wave night regardless of time spent in supine position compared to baseline polysomnography.|||mins||Standard Deviation|Mean
2593556|NCT02244918|Secondary|Cigarettes Used|Cigarettes used in the past 30 days from baseline through week 26|Weeks 0-26|The number of participants analyzed at follow-up time-points reflects only those who returned at that point.|||Cigarettes used in the past 30 days||Standard Deviation|Mean
2593019|NCT02250417|Primary|Apnea-hypopnea Index (AHI)- Intention to Treat Analysis|"AHI, or the apnea-hypopnea index, is a numerical measure that accounts for the number of pauses in your breathing per hour of sleep.~These breathing disturbances are typically associated with either a brief arousal or awakening from sleep or a 4 percent drop in the blood oxygen levels, called a desaturation. It is used to assess the severity of an individual's sleep apnea.~This is measured in each study participant when sleeping with the Wave Sleep Surface and sleeping without the Wave Sleep Surface."|measured during each of the two sleep study sessions (Study Visits 2 and 3)|The study compares the difference in AHI within each study subject with and without the use of the Wave Sleep Surface during visit 2 and 3 (intention to treat analysis).|||events/hr||Standard Deviation|Mean
2593020|NCT02250326|Secondary|Percentage of Participants With Study Drug Dose Reductions|A dose reduction occurred when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions were typically caused by clinically significant laboratory abnormalities and/or TEAEs or toxicities.|Up to 16 Jan 2017 for CC-486 + nab-paclitaxel and up to 23 Dec 2017 for nab-paclitaxel and Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel|The treated population consisted of all participants who were randomized or assigned and received at least 1 dose of investigational product.|||Percentage of Participants|||Number
2593021|NCT02250326|Secondary|Dose Intensity Per Week of Durvalumab|Dose intensity was the cumulative dose divided by the dosing period in weeks).|Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel|The treated population consisted of all participants who randomized or assigned and received at least 1 dose of investigational Product.|||mg/week||Standard Deviation|Mean
2593022|NCT02250326|Secondary|Dose Intensity Per Week of CC-486|Dose intensity was the cumulative dose divided by the dosing period in weeks.|Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel|The treated population consisted of all participants who randomized or assigned and received at least 1 dose of IP.|||mg/ week||Standard Deviation|Mean
2593023|NCT02250326|Secondary|Dose Intensity Per Week of Nab-Paclitaxel|Dose intensity was the cumulative dose divided by the dosing period in weeks.|Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel|The treated population consisted of all participants who were randomized or assigned and received at least 1 dose of IP.|||mg/m^2/week||Standard Deviation|Mean
2593024|NCT02250326|Secondary|Percentage of Participants Who Discontinued Study Treatment|The discontinuation rate was defined as the percentage of participants who had study drug discontinued and was assessed throughout the conduct of the study.|Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel|Treated population included all participants who were randomized or assigned and received at least 1 dose of study drug.|||percentage of participants|||Number
2593025|NCT02250326|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period|TEAEs were defined as any adverse event or serious adverse event that occurred or worsened on or after the day of the first dose of the IP through 28 days after the last dose of IP for Arms A and C or up to 90 days after the last dose for Arm B, and those SAEs made known to the investigator at any time thereafter that are suspected of being related to IP. A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild l intervention/therapy required Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.|TEAEs were collected up to 4 weeks after receiving last dose of IP for nab-paclitaxel and CC-486 + nab-paclitaxel, and up to 90 days after the last IP dose for Durva + nab-paclitaxel; TEAEs were collected up to 86.1 weeks|Safety Population included all participants who were randomized or assigned and received at least 1 dose of study drug.|||Participants|||Count of Participants
2593026|NCT02250326|Secondary|Kaplan Meier Estimate of Overall Survival (OS)|Overall survival was defined as the time in months between randomization/treatment assignment and death from any cause. Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.|Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; participants were followed for overall survival up to 30 months|ITT Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.|||Months||95% Confidence Interval|Median
2593027|NCT02250326|Secondary|Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response According to RECIST V 1.1 Criteria|Overall Response was defined as percentage of participants who achieved a radiologic confirmed complete response or partial response according to RECIST V 1.1 criteria and compared with baseline among all tumor assessments, where baseline was the last CT obtained prior to or on Day 1 of treatment. Per RECIST V 1.1 criteria, a CR is defined as a disappearance of all target lesions; a PR is defined as having at least a 30% decrease in the sum of diameters of target lesions from baseline. Responses were evaluated every 6 weeks.|Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel|ITT Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.|||percentage of participants||95% Confidence Interval|Number
2594356|NCT02233738|Secondary|Quality of Life Survey (QOLS) at 1 Month|Min value:16 Max value:112 Higher score indicates higher quality of life|1 month||||score on a scale||Standard Deviation|Mean
2593028|NCT02250326|Secondary|Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to RECIST V 1.1 Criteria|"Disease control rate was defined as the percentage of participants who had a CR, PR or SD during the course of the study, according to RECIST version 1.1 criteria, as evaluated by the investigator. RECIST Version 1.1 criteria is defined as follows:~Complete Response is the disappearance of all target lesions;~Partial Response is at least a 30% decrease in the sum of diameters of target lesions from baseline;~Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease. Responses were evaluated every 6 weeks."|Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel|ITT Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.|||Percentage of Participants||95% Confidence Interval|Number
2593029|NCT02250326|Primary|Kaplan Meier Estimate of Progression-Free Survival (PFS) as Assessed by the Investigator|Progression-free survival was defined as the time in months from the date of randomization/assignment to the date of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria documented by computed tomography (CT) scan, not including symptomatic deterioration, or death (any cause) on or prior to the clinical cut-off date, which ever occurred earlier. Participants who did not have disease progression and had not died, regardless of whether they were discontinued from treatment, were censored at the date of last tumor assessment, on or prior to the clinical cut-off date that the participant was progression free. Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions from nadir.|From date of first dose of IP to DP; up to data cut-off date of 30 August (Aug) 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 December (Dec) 2017 for Durva + nab-paclitaxel; participants were followed for PFS for up to 18 months|Intent to Treat Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.|||months||95% Confidence Interval|Median
2593030|NCT02250274|Secondary|Ratio Between Immunoglobulin A (IgA):Immunoglobulin G (IgG)||Day 7|There were too few samples collected within each group to conduct a reasonable analysis of this outcome. The samples collected are being stored for potential future use.||||||
2593031|NCT02250274|Secondary|Antibody Dependent Cellular Cytotoxicity (ADCC) Titers||Change from Baseline to 28 days|Fold change in NK cell degranulation|||Fold change||95% Confidence Interval|Geometric Mean
2593032|NCT02250274|Secondary|Polymerase Chain Reaction (PCR) Confirmed Influenza Illness||Onset >13 days after vaccination and before April 1, 2015||||participants|||Number
2593033|NCT02250274|Primary|Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza||Change from Baseline to 28 days||||Titers||95% Confidence Interval|Geometric Mean
2593034|NCT02250183|Other Pre-specified|Cost of Treatment (MEDIHONEY vs. SANTYL) Supplies|The total treatment costs for MEDIHONEY® GEL and SANTYL® ointment will be summed across participants. The total number of SANTYL® tubes and MEDIHONEY® GEL patches used will be totaled for each participant, multiplied by cost, and then compared within subjects with a paired samples, t-test.|At the end of treatment, which can last from 7 to 21 days after enrollment|We did not analyze these data because we determined later that the values were confounded by multiple uncontrolled factors - i.e., size of the burn, unstandardized patient variation in amount of cream used (as treatment was performed at home). Normalizing values to burn size would not be sufficient to make valid comparison.||||||
2593035|NCT02250183|Other Pre-specified|Patient Satisfaction Questionnaire Score at End of Study Participation|Patients rated their experience separately for MEDIHONEY & SANTYL treatment. Responses were 6-point Likert type ratings across 6 items measuring pain, burn appearance, ease of use, and willingness to recommend that treatment to other patients. Potential score range was 6-36, with higher scores representing greater satisfaction.The mean difference in participant satisfaction for the MEDIHONEY® GEL and SANTYL® ointment treatments was assessed via a within-subject, two-tailed t-test.|7 to 21 days after enrollment, depending on time it takes for burn injury to completely heal or to discontinue study participation|Each participant received both treatment arms (single group study). To reduce bias in results, participants not lost to follow-up were asked to complete this survey, regardless of whether they completed the study or discontinued participation due to withdrawal, need for treatment change, or adverse event. Six participants were missing this measure.|||score on a scale||Standard Deviation|Mean
2593036|NCT02250183|Secondary|Number of Participants With Presence vs. Absence of Bacteria in Burn Wound|Wound swab culture results will be compared between treatment modalities via a McNemar test, with treatment modality (MEDIHONEY® GEL versus SANTYL® ointment) and outcome (Positive versus Negative wound culture results for presence of Pseudomonas aeruginosa and/or other bacteria) as the independent and dependent variables, respectively. Each participant has two wound cultures, one for MEDIHONEY® GEL and one for SANTYL® ointment.|Day 7 of study|Each participant received both arms of treatment to control for individual healing factors (thus, this is a single group study & McNemar test is used). Seven participants had missing wound culture data for one or both treatment conditions.|||participants|||Number
2593037|NCT02250183|Primary|Change in Wound Appearance|"Pictures of wounds and associated seepage test paper towels, without indication of date or arm of treatment, were rated by two independent physicians regarding healed or not yet healed. This information was then be used to calculate a time to heal variable (# of days) for each patient."|Daily for 7 to 21 days, depending on time it takes burn injury to completely heal|Each participant received both arms of treatment to control for individual healing factors (thus, this is a single group study). Initial analyses yielded inconclusive agreement on healing time due to low quality of pictures (e.g., lighting, focus) and physician reported difficulty in using still photos in isolation to judge wound healing.||||||
2593038|NCT02249949|Secondary|Incidence of Grade 3+ Adverse Events Summarized Using Common Terminology Criteria for Adverse Events Version 4.0|Incidence of grade 3+ adverse events summarized using Common Terminology Criteria for Adverse Events version 4.0: The frequency and percentage of grade 3+ adverse events will be estimated|Up to 5 years||||Participants|||Count of Participants
2593557|NCT02244918|Secondary|Total Days Abstinent|Number of days abstinent from baseline through week 26.|Week 0-26|The number of participants analyzed at follow-up time-points reflects only those who returned at that point.|||days abstinent in the past 30 days||Standard Deviation|Mean
2593040|NCT02249949|Secondary|Progression Free Survival (PFS) Determined Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1|Progression free survival (PFS) is defined as the time from study entry to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Time from study entry to the first of either disease progression or death from any cause, assessed up to 5 years||||months||95% Confidence Interval|Median
2593041|NCT02249949|Primary|Confirmed Overall Response Rate Per the RECIST 1.1 Criteria|The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.|Up to 24 weeks (8 cycles)||||percentage of patients||95% Confidence Interval|Number
2593042|NCT02249832|Secondary|Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace.|Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (>0.8m/sec) functioning. Mean distance walked (m) on the 6 Minute Walk test at comfortable pace were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).|baseline, discharge (week 6), 3 month FU (overall week 18)|Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance levels.|||meters||Standard Error|Mean
2593043|NCT02249832|Secondary|Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace.|Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (>0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at fast pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).|baseline, discharge (week 6), 3 month FU (overall week 18)|Subjects were stratified according to clinically established gait speed impairment levels based on average admission gait speed on the 10 Meter Walk Test at comfortable pace.|||m/sec||Standard Error|Mean
2593044|NCT02249832|Primary|Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace.|Subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (>0.8m/sec) functioning. Mean gait speeds on the 10m Walk Test at comfortable pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).|baseline, discharge (week 6), 3 month FU (overall week 18)|Subjects were stratified according to clinically established gait speed impairment levels based on average admission gait speed on the 10 Meter Walk Test at comfortable pace.|||m/sec||Standard Error|Mean
2593045|NCT02249819|Primary|Mean Change in Picture-naming Accuracy Score|The mean change in verbal picture-naming accuracy score (out of 75) was calculated from baseline to discharge in each condition (sham and active tDCS).|baseline, discharge|All participants received one dose of each intervention and completed all study visits. They were consequently all included in the efficacy analysis.|||score||Standard Deviation|Mean
2593046|NCT02249793|Secondary|Changes Over Time in Kidney Function||48 hours|Kidney function was done to evaluate healthy volunteers during Session 1 and 2. Delta was calculated between Session 1 and 2 and averaged across subjects. Note that values for session1 was missing for two subjects, meaning that below reported mean and standard deviation reflect changes for four subjects.|||mg/dL||Standard Deviation|Mean
2593047|NCT02249793|Secondary|Proteins Displaying Different Abundances Measured in the Morning Versus Evening Hours|Analysis was performed for all participants as a group.|48 hours||||Proteins|||Number
2593048|NCT02249793|Secondary|Genera Displaying Different Abundances Measured During Morning Versus Evening Hours in the Oral Microbiome|Analysis was performed for all participants as a group.|48 hours||||genera|||Number
2593049|NCT02249793|Secondary|Changes Over Time in Ribonucleic Acids (RNA) - ARNTL (BMAL1) Normalized to GAPDH||48 hours||||relative expression||Standard Deviation|Mean
2593050|NCT02249793|Secondary|Changes Over Time in Nutrient Intake - Energy|Nutrient intake will be measured using food photography|48 hours||||Kcals||Standard Deviation|Mean
2593051|NCT02249793|Secondary|Physical Activity|Difference in locomotion between wake and sleep times|3-4 months||||Counts/min||Full Range|Mean
2593052|NCT02249793|Secondary|Time Asleep|Hours asleep per each 24 hour period measured by actigraphy|3-4 months||||hours||Standard Deviation|Mean
2593053|NCT02249793|Secondary|Self-reported Sleep Times [Survey]|Cell phone administered survey where participants indicated start and end of sleep times. From this the total hours of sleep per night was calculated.|3-4 months||||hour||Standard Deviation|Mean
2593054|NCT02249793|Primary|Text Messages|The number of sms messages (sent + received)|3-4 months||||messages||Full Range|Mean
2593055|NCT02249793|Primary|Text Message Length|The total length of all sms messages (sent + received) in characters|3-4 months||||n (characters)||Full Range|Mean
2593056|NCT02249793|Primary|Call Duration|The duration of calls (made + received)|3-4 months||||Seconds||Full Range|Mean
2593057|NCT02249793|Primary|Unique Contacts|The total number of unique individuals with whom a participant interacted through phone calls or sms messages indicating interaction diversity|3-4 months||||Unique contacts||Full Range|Mean
2593058|NCT02249793|Primary|Unanswered Calls|The number of calls unanswered.|3-4 months||||Unanswered calls||Full Range|Mean
2593059|NCT02249793|Primary|Changes Over Time in Ambulatory Blood Pressure - Diastolic Blood Pressure|Ambulatory blood pressure monitoring|48 hours||||mmHg||Standard Deviation|Mean
2593060|NCT02249793|Primary|Calls|Number of phone calls placed and received|3-4 months||||Calls||Full Range|Mean
2593061|NCT02249793|Primary|Mobility Radius|The approximate radius of an imaginary circle encompassing the various locations that a user has traveled across on a particular day (in miles)|3-4 months||||miles||Full Range|Mean
2593065|NCT02249767|Primary|Percent Change in Baseline Acne Lesions at Week 12|Percent change in baseline in inflammatory and non-inflammatory lesions at week 12.|Baseline and 12 weeks|This is Per protocol population (PP) Analysis. Generic Tretinoin Intent to Treat (ITT) started 222- 22 excluded as not following protocol= 200 PP. Brand Tretinoin 220 ITT - 11 excluded not following Protocol=209 PP. Placebo 107 ITT - 7 excluded = 100 PP Percent change from baseline in acne lesions|||Percent reduction||Standard Deviation|Mean
2593066|NCT02249728|Secondary|Oral PK Profile of [14C]-PBT2 as Assessed by AUC(0-last)|area under the plasma concentration vs time curve to the last timepoint|0 to 72 hours|PK Population|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2593067|NCT02249728|Secondary|Ratio of Whole Blood, Plasma [14C] PBT2 at 24 Hours|Ratio of whole blood, plasma [14C] PBT2 at 24 hours|0 to 24 hours|PK population|||ratio [14C] PBT2||Geometric Coefficient of Variation|Geometric Mean
2593068|NCT02249728|Secondary|Safety and Tolerability of PBT2|As assessed by the number of participants with adverse events|72 h post oral dose|Safety Population|||participants|||Number
2593069|NCT02249728|Secondary|Oral PK Profile of PBT2 as Assessed by AUC(0-last)|Area under the plasma concentration vs time curve from time 0h to the last time point of oral PBT2 .|72 h post oral dose||||ng*hr/ml||Geometric Coefficient of Variation|Geometric Mean
2593070|NCT02249728|Secondary|IV PK Profile of [14C]-PBT2 and Total Radioactivity as Assessed by AUC(0 Last)|Area under the plasma concentration vs time curve from time 0h to the last time point of IV [14C]-PBT2 .|0 to 72 h post oral dose|PK Population|||ng*hr/ml||Geometric Coefficient of Variation|Geometric Mean
2593071|NCT02249728|Primary|Mass Balance|Amount excreted as a percentage of the administered dose (%Ae)|168 h (7 days) post dose|PK Population|||percentage of administered dose||Standard Deviation|Geometric Mean
2593072|NCT02249728|Primary|Absolute Bioavailability of PBT2 (F%)|Absolute bioavailability is the amount of drug from a formulation that reaches the systemic circulation relative to an IV dose, computed as AUC(oral)/AUC(IV), with range from 0% (no drug) to 100% (all of the administered drug).|0 to 72 hours post oral dose|PK Population|||percentage of absolute bioavailability||Standard Deviation|Mean
2593073|NCT02249585|Secondary|Surgical Rating Scale|The surgical rating scale was assessed by the surgeon and graded as a five-point scale: optimal, good, acceptable, poor, and extremely poor conditions.|1 min after laparoscopic procedure||||Participants|||Count of Participants
2593074|NCT02249585|Secondary|Pulmonary Compliance|Pulmonary compliance during laparoscopic surgery. The pulmonary compliance was calculated from the plateau and peak inspiratory pressures, positive end-expiratory pressure, and tidal volume measured with an anesthetic machine (Primus; Dräger, Lübeck, Germany).|1, 30, 60, 90, and 120 minutes after onset of laparoscopy||||mL/cmH2O||Standard Deviation|Mean
2593075|NCT02249585|Secondary|PaO2|PaO2 measured during laparoscopic surgery. The PaO2 (arterial partial pressure of oxygen) was measured with the blood gas analyzer (GEM Premier 3000, Model 5700; Instrumentation Laboratory, Lexington, MA, USA).|1, 30, 60, 90, and 120 minutes after onset of laparoscopy||||kPa||Standard Deviation|Mean
2593076|NCT02249585|Secondary|Stroke Volume Index (SVI)|Stroke volume index during the surgery. The stroke volume index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.|1, 30, 60, 90, 120 min after onset of laparoscopy||||mL/beat/m^2||Standard Deviation|Mean
2593077|NCT02249585|Secondary|Mean Arterial Blood Pressure (MBP)|Mean arterial blood pressure measured during laparoscopic surgery. The mean arterial blood pressure was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.|1, 30, 60, 90, and 120 minutes after onset of laparoscopy||||mmHg||Standard Deviation|Mean
2593078|NCT02249585|Primary|Cardiac Index|Cardiac index 30 min after onset of laparoscopy. The cardiac index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.|30 min after onset of laparoscopy||||L/min/m^2||Standard Deviation|Mean
2593079|NCT02249377|Secondary|Side Effects|All disease signs and symptoms experienced by the patient, as defined as an Adverse Event (AE), Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Unexpected Adverse Device Effect (UADE), will be recorded from questionnaires during each study visit.|6 Months|The study was terminated due to lack of funding. Efforts were made to collect data, but were unsuccessful. No study data are available.||||||
2593080|NCT02249377|Secondary|Complications|All disease signs and symptoms experienced by the patient, as defined as an Adverse Event (AE), Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Unexpected Adverse Device Effect (UADE), will be recorded from questionnaires during each study visit.|6 Months|The study was terminated due to lack of funding. Efforts were made to collect data, but were unsuccessful. No study data are available.||||||
2593081|NCT02249377|Secondary|Recurrence of Baker's Cysts Treated on Each Group|Outcome measure will be determined through the use of the Visual Analogue Score (VAS) and the Rauschning and Lindgren criteria which are used to clinically evaluate the presence of the popliteal cysts, pain, posterior sense of tension in the popliteal fossa and its clinical importance for range of motion reduction. The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess short and long term outcome of knee related conditions.|6 Months|The study was terminated due to lack of funding. Efforts were made to collect data, but were unsuccessful. No study data are available.||||||
2593082|NCT02249377|Primary|Outcome of Baker's Cysts With the Use of Platelets-Rich-Plasma Versus Corticosteroid|Outcome measure will be determined through the use of the Visual Analogue Score (VAS) and the Rauschning and Lindgren criteria which are used to clinically evaluate the presence of the popliteal cysts, pain, posterior sense of tension in the popliteal fossa and its clinical importance for range of motion reduction. The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess short and long term outcome of knee related conditions.|6 Months|The study was terminated due to lack of funding. Efforts were made to collect data, but were unsuccessful. No study data are available.||||||
2593095|NCT02249182|Secondary|For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough|Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment.|Up to 24 weeks|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2594357|NCT02233738|Secondary|Quality of Life Survey (QOLS) at Baseline|Min value:16 Max value:112 Higher score indicates higher quality of life|30 days prior to Baseline||||score on a scale||Standard Deviation|Mean
2593083|NCT02249182|Secondary|Acceptability of LDV/SOF Granules as Measured by Palatability at Day 1|Participants who were dosed with granules were asked if they tasted the study drug. If they tasted it, then they were asked to provide a number from 0 to 100 to rate the taste of the study drug, with higher scores indicating better taste. Data was then summarized as percentage of participants choosing the following palatability categories: 1) Did not taste the study drug, 2) Tasted drug with score > 60 to 100, 3) Tasted drug with score 40 to 60, and 4) Tasted drug with score of 0 to < 40.|Day 1|Participants between 3 to <6 years old in the Safety Analysis Set who performed the palatability test were analyzed.|||percentage of participants|||Number
2593084|NCT02249182|Secondary|Acceptability of LDV/SOF Tablets as Measured by the Percentage of Participants Able/Unable to Swallow Placebo Tablet at Day 1|Participants who were able/unable to swallow placebo tablets were assessed. Participants 12 to < 18 years old were first asked to perform the swallowability assessment using the 90/400 mg placebo tablet. If they were unable to swallow this, they were then asked to perform the swallowability assessment with 22.5/100 mg placebo tablets. Participants 6 to < 12 years old were to be assessed with the 22.5/100 mg placebo tablets. However, 8 participants were mistakenly assessed using the 90/400 mg placebo tablet.|Day 1|Participants between 6 to <18 years old in the Safety Analysis Set who performed the swallowability assessment were analyzed.|||percentage of participants|||Number
2593085|NCT02249182|Secondary|For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development|Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.|Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24|Female participants in the Safety Analysis Set with available data were analyzed.|||Participants|||Count of Participants
2593086|NCT02249182|Secondary|For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair|Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.|Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24|Female participants in the Safety Analysis Set with available data were analyzed.|||Participants|||Count of Participants
2593087|NCT02249182|Secondary|For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development|Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.|Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24|Male participants in the Safety Analysis Set with available data were analyzed.|||Participants|||Count of Participants
2593088|NCT02249182|Secondary|For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair|Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.|Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24|Male participants in the Safety Analysis Set with available data were analyzed.|||Participants|||Count of Participants
2593089|NCT02249182|Secondary|For the Treatment Phase, Change From Baseline in Weight||Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24|Participants in the Safety Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.|||kilograms||Standard Deviation|Mean
2593090|NCT02249182|Secondary|For the Treatment Phase, Change From Baseline in Height||Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24|Participants in the Safety Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.|||centimeters||Standard Deviation|Mean
2593091|NCT02249182|Secondary|For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization|ALT normalization was defined as ALT > the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit.|Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4|Participants in the Full Analysis Set with ALT > ULN at Baseline with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks.|||percentage of participants|||Number
2593092|NCT02249182|Secondary|For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment||Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)|Participants in the Full Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks.|||percentage of participants||95% Confidence Interval|Number
2593093|NCT02249182|Secondary|For the Treatment Phase, Change From Baseline in HCV RNA||Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)|Participants in the Full Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.|||log10 IU/mL||Standard Deviation|Mean
2593094|NCT02249182|Secondary|For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.|Up to Posttreatment Week 24|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2593096|NCT02249182|Secondary|For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)|SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2593097|NCT02249182|Secondary|For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < LLOQ at 12 weeks after stopping study treatment.|Posttreatment Week 12|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2593098|NCT02249182|Secondary|For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2593099|NCT02249182|Secondary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase||Up to Day 10|Participants who were enrolled in the PK lead-in phase were analyzed.|||percentage of participants|||Number
2593100|NCT02249182|Secondary|For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA||Baseline; Weeks 1, 2, 4, 8, and 12|Participants who were enrolled in the PK lead-in phase with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2593101|NCT02249182|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase||Up to 24 weeks|Safety Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.|||percentage of participants|||Number
2593102|NCT02249182|Primary|For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF), LDV, and SOF|AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).|Cohorts 1 and 2 (6 to < 18 years of age): predose, 0.5, 1, 2, 3, 4, 5, 8, and 12 hours postdose on Day 10; Cohort 3 (3 to < 6 years of age): predose, 0.5, 2, 4, 8, and 12 hours postdose on Day 10|Intensive PK Analysis Set included all participants in the PK lead-in phase who received at least 1 dose of study drug and for whom at least 1 nonmissing PK concentration value, during the intensive sampling period, was reported by the PK laboratory.|||h*ng/mL||Standard Deviation|Mean
2593103|NCT02249143|Other Pre-specified|Days in the Hospital|The days in the hospital will be compared between the randomized groups.|Delivery through discharge at about 35-37 weeks of corrected gestational age|Data not collected||||||
2593104|NCT02249143|Other Pre-specified|Days on Oxygen Between the Randomized Groups|The days of oxygen supplementation will be compared between the groups of randomized patients.|Through discharge at about 35-37 weeks of corrected gestational age||||days||Inter-Quartile Range|Mean
2593105|NCT02249143|Other Pre-specified|Cost Comparison Between Randomized Groups|Cost comparison through 12 months of corrected gestational age between the randomized groups per percent improvement in FRC measured at discharge between the groups.|Through 12 months of corrected age|Data not collected||||||
2593106|NCT02249143|Other Pre-specified|Incidence of Wheezing Through One Year of Age|Incidence of wheezing will be compared through one year of corrected gestational age between the randomized groups.|Discharge through one year of corrected age|Number of participants analyzed is lower here as we were not able to follow all infants through 1 year of corrected age.|||Participants|||Count of Participants
2593107|NCT02249143|Other Pre-specified|Corrected Gestational Age at Which Full Nipple Feeds Are Achieved|The corrected gestational age at which full nipple feeds are achieved will be compared between the randomized groups.|Randomization through discharge at about 35-37 weeks of corrected gestational age.||||weeks||Inter-Quartile Range|Median
2593108|NCT02249143|Other Pre-specified|The Number of Participants With Adverse Events and Serious Adverse Events in the Randomized Groups of Premature Infants.|Adverse events and serious adverse events occurring in the randomized groups will be documented carefully|From randomization through discharge from the neonatal intensive care unit (an average of 35 to 37 weeks of corrected gestational age).||||participants|||Number
2593109|NCT02249143|Other Pre-specified|Changes in the Growth Parameters Between the Randomized Premature Infants|Changes in growth parameters will be compared between randomized groups.|From randomization through discharge at about 35-37 weeks of corrected gestational age.||||g||Standard Deviation|Mean
2593110|NCT02249143|Secondary|Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants.|Characteristics of tidal flow volume loops will be measured.|Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age.||||mL||Standard Deviation|Mean
2593111|NCT02249143|Secondary|Passive Respiratory Resistance in Randomized Premature Infants|Measurements of passive respiratory resistance will be done with the single breath occlusion technique.|Just prior to randomization, two weeks after randomization, and at discharge at about 35-37 weeks of corrected gestational age.||||cmH2O/mL/sec||Standard Deviation|Mean
2593112|NCT02249143|Secondary|Measurements of Passive Respiratory Compliance in Randomized Premature Infants|Measurements of passive respiratory compliance will be done with the single breath occlusion technique.|Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age||||mL/Kg||Standard Deviation|Mean
2593113|NCT02249143|Primary|Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants|Functional residual capacity (FRC) was measured with the nitrogen washout technique. For the nitrogen washout technique, calibration is done with 2 known volumes, and a calibration line was constructed for the system at the specific flow rate and used to correlate the nitrogen washed out to the infant's FRC. The system corrected for dead space and corrected the FRC to body temperature, pressure, and water-saturated conditions. Acceptance criteria included: 1) infant supine and quietly asleep; 2) test initiated at end expiration; 3) no evidence of leak on tracing of the washout; 4) consistent tracings; 5) at least 2-3 measurements with a coefficient of variation <10%. These are testing and acceptance criteria outlined by the American Thoracic Society and European Respiratory Society.|Just prior to randomization, two weeks later and at discharge (an average of 34 to 37 weeks of corrected gestational age).||||mL||Standard Deviation|Mean
2593121|NCT02249065|Secondary|Facial Redness Visual Analog Scale (VAS)|The number and percent of subjects in each transformed response category for the in-office subject reported facial redness VAS|14 days (Day 1 (Baseline), Day 14/Exit)|ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment|||Participants|||Count of Participants
2593122|NCT02249065|Secondary|Subject Treatment Satisfaction Questionnaire|Mean Subject Treatment Satisfaction at Day 14 (Average Response Across 12 Questions)|14 days (Day 14/Exit)|ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment|||Participants||Standard Deviation|Mean
2593123|NCT02249065|Secondary|Subject Facial Redness Questionnaire|Facial Redness Questionnaire at Day 1 and Day 14 (Mean Number of Subjects Who's Responses Indicate They Were/Were Not Bothered By Facial Redness, Across All 11 Facial Redness Questions)|14 days (Day 1 (Baseline) and Day 14/Exit)|ITT Population, Subjects who received at least 1 application of study drug, and completed at least 1 assessment|||Participants||Standard Deviation|Mean
2593124|NCT02249065|Primary|Pre-Treatment Clinician Erythema Assessment (CEA)|The number and percent of subjects in each CEA score category at each visit. CEA was conducted at the screening/baseline visit and all subsequent visits prior to the study drug application.|14 days (Day 1 (Baseline), Day 7, and Day 14/Exit)|Intent-to-treat (ITT) Population; Subjects who received at least 1 application of study drug, and completed at least 1 assessment|||Participants|||Count of Participants
2593125|NCT02249052|Other Pre-specified|Change in Visible Surface Area|"Visible surface area is defined as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be analyzed as the percent change from baseline."|3 month post injection|All 19 subjects enrolled with 2 lipomas. All received AA4500 in one lipoma and placebo in the other lipoma.|||percentage change from baseline||Standard Deviation|Mean
2593126|NCT02249052|Other Pre-specified|Change in Visible Surface Area|"Visible surface area is defined as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be analyzed as the percent change from baseline."|1 Month post injection|All 19 subjects enrolled with 2 lipomas. All received AA4500 in one lipoma and placebo in the other lipoma.|||percentage change from baseline||Standard Deviation|Mean
2593127|NCT02249052|Secondary|Subject Satisfaction|Subjects very satisfied or somewhat satisfied with study treatment based upon Subject Questionnaire|6 months|1 participant did not complete the questionnaire at the final visit; therefore the analysis population was based upon 18 participants|||participants satisfied|||Number
2593128|NCT02249052|Secondary|Percent Change From Baseline in Greatest Dimension (Length) of Lipoma at 6 Months|Change from baseline in lipoma length Calculated as the percent change from baseline for length of the lipoma treated with AA4500 and the lipoma treated with placebo.|Baseline and 6 months|All study participants|||Percent change from baseline||Standard Deviation|Mean
2593129|NCT02249052|Secondary|Responder Analysis|The number of participants with at least 50% decrease in visible lipoma surface area of lipoma relative to baseline|Baseline and 6 months|All 19 participants|||participants|||Number
2593130|NCT02249052|Primary|Percent Change From Baseline in Surface Area of the Lipoma at Six Months|"The primary efficacy outcome is lipoma visible surface area defined as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be analyzed as the percent change from baseline at the 6-month visit."|Baseline and 6 months post injection|All 19 subjects enrolled with 2 lipomas. All received AA4500 in one lipoma and placebo in the other lipoma.|||percentage change from baseline||Standard Deviation|Mean
2593131|NCT02248974|Secondary|Participants' Control Preferences Over Treatment Decision-Making|This data is based on responses to a 1-item questionnaire (i.e. not a scale). Scores are calculated by counting the frequency of matches in patient-reported preferences at two time points (baseline and 1-month follow-up).|1-Month|Analysis only included participants who completed the measure at baseline, minus participants lost to attrition between baseline and 1-month follow-up.|||Participants|||Count of Participants
2593132|NCT02248974|Secondary|Participants' Control Preferences Over Treatment Decision-Making|This data is based on responses to a 1-item questionnaire (i.e. not a scale). Scores are calculated by counting the frequency of matches in patient-reported preferences at two time points.|Baseline|Analysis only included participants who completed the measure at baseline.|||Participants|||Count of Participants
2593133|NCT02248974|Secondary|Usability and Acceptability: Helped me to Think About Aspects of Heart Failure Treatment That Matter Most to me.|Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool|1 Day Follow-up|Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.|||Participants|||Count of Participants
2593134|NCT02248974|Secondary|Usability and Acceptability: Helps Someone Make an Informed Decision.|Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool|1 Day Follow-up|Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.|||Participants|||Count of Participants
2593135|NCT02248974|Secondary|Usability and Acceptability: Held my Interest.|Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool|1 Day Follow-up|Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 37 patients in the DA group. The no-DA group did not receive the measure.|||Participants|||Count of Participants
2593136|NCT02248974|Secondary|Usability and Acceptability: Would Recommend to Others.|Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool|1 Day Follow-up|Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 37 patients in the DA group. The no-DA group did not receive the measure.|||Participants|||Count of Participants
2593137|NCT02248974|Secondary|Usability and Acceptability: Learned Something New That I Didn't Know Before.|Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool|1 Day Follow-up|Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.|||Participants|||Count of Participants
2605757|NCT02107014|Primary|Change in IL-7 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2593138|NCT02248974|Secondary|Usability and Acceptability: Helped me Understand my Options for Dealing With Heart Failure.|Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool|1 Day Follow-up|Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.|||Participants|||Count of Participants
2593139|NCT02248974|Secondary|Number and Percentage of Patients Who Filled Out an Advanced Directive|Number and percentage of patients who filled out an Advanced Directive, using a binary measure indicating whether a respondent has filled out an advanced directive (1) or not (0).|1-Month Follow-Up|Analysis only includes participants who responded to the question (DA=25, no-DA=27, Total=52).|||Participants|||Count of Participants
2593140|NCT02248974|Secondary|Number of Patients Whose Preferred Treatment Was LVAD|Number of patients who definitively choose LVAD treatment, measured using a binary score representing yes (1) or no (0) indicating whether the patient chose LVAD as a preferred treatment for their advanced heart failure.|1-Month Follow-Up|Analysis only includes participants who responded to the question at 1-Month (DA=26, no-DA=32, Total=58).|||Participants|||Count of Participants
2593141|NCT02248974|Secondary|Number of Patients Whose Preferred Treatment Was LVAD|Number of patients who definitively choose LVAD treatment, measured using a binary score representing yes (1) or no (0) indicating whether the patient chose LVAD as a preferred treatment for their advanced heart failure.|1-Week Follow-Up|Analysis only includes participants who responded to the question at 1-Week (DA=28, no-DA=33, Total=61).|||Participants|||Count of Participants
2593142|NCT02248974|Secondary|Preferred Treatment: Number of Patients Predicting They Will Choose LVAD|Number of patients forecasting that they will choose LVAD treatment (before their actual decision), measured using a binary score representing yes (1) or no (0) indicating whether a patient predicted they would choose LVAD as a preferred treatment for their advanced heart failure.|Baseline|Analysis only includes participants who responded to the question at baseline (DA=46, no-DA=50, Total=96).|||Participants|||Count of Participants
2593143|NCT02248974|Secondary|Quality of Life -- Health Rating|"Responses to the question: On a scale of 0 to 100 (0 is the worst health imaginable, 100 is the best health imaginable) what would you rate your health today?"|1-Month Follow-Up|Analysis included only those participants who completed measure at 1-Month (DA=26, no-DA=30, Total=56).|||units on a scale||Standard Deviation|Mean
2593144|NCT02248974|Secondary|Quality of Life -- Health Rating|"Responses to the question: On a scale of 0 to 100 (0 is the worst health imaginable, 100 is the best health imaginable) what would you rate your health today?"|Baseline|Analysis included only those participants who completed the measure at baseline (DA=46, no-DA=50, Total=96).|||units on a scale||Standard Deviation|Mean
2593145|NCT02248974|Secondary|Satisfaction With Life|Satisfaction with Life Scale, intended to measure respondents' perceived global life satisfaction. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.|1-Month Follow-Up|Analysis only included those participants who completed the measure at 1-Month Follow-Up (DA=26, no=DA=30, Total=56).|||units on a scale||Standard Deviation|Mean
2593146|NCT02248974|Secondary|Participants' Perceived Survival Estimate in Number of Years After LVAD Implant|Patient-reported estimate of number of years the average patient is able to live after LVAD implant. Participants wrote in a number in a blank space, and numbers were recorded.|1-Week Follow-Up|Analysis only includes those participants who responded to the measure at 1-Week Follow-Up (DA=27, no-DA=28, Total=55).|||years||Standard Deviation|Mean
2593147|NCT02248974|Secondary|Number and Percentage of Participants Who Perceived and Strong Likelihood of Transplant|Number and Percentage of participants who perceived and strong Likelihood of Transplant after 1-Month follow-up.|1-Month Follow-Up|Analysis included only those participants who responded to the measure at 1-month (DA=27, no-DA=31, Total=58).|||Participants|||Count of Participants
2593148|NCT02248974|Secondary|Number & Percentage of Participants Who Perceived a Strong Likelihood of Transplant|Measures the number and percentage of participants who perceived a strong likelihood of transplant.|1-Week Follow-Up|Analysis included only those participants who responded to the measure at 1-week (DA=26, no=DA=33, Total=59).|||Participants|||Count of Participants
2593149|NCT02248974|Secondary|Number and Percentage of Participants Reporting Ability to Envision Life With an LVAD: Difficult/no Idea What to Expect|"Number and percentage of patients reporting that their ability to envision life with an LVAD was Difficult or that they had No idea."|1-Month Follow-Up|Analysis only includes those who responded to this measure (DA=20, no-DA =21, Total=41).|||Participants|||Count of Participants
2593150|NCT02248974|Secondary|Ability to Envision Life With an LVAD: Somewhat/Easy Picturing What to Expect|"Percentage of patients reporting that their ability to envision life with an LVAD was Somewhat Easy or Easy."|1-Week Follow-Up|Analysis only includes those who responded to this measure (DA=27, no-DA =33, Total=60).|||Participants|||Count of Participants
2593151|NCT02248974|Secondary|Number and Percentage of Participants Whose Control Preferences for Treatment Decision-Making Match From Baseline to 1-month Follow-up|"Measure of the degree (percentage) of match in patient-reported preferences related to control over treatment decision at Baseline and 1-Month. This data is based on responses to a 1-item questionnaire (i.e. not a scale). Scores are calculated by counting the frequency of matches in patient-reported preferences at two time points. The results are reported as the number of participants with a 1:1 match in preferences at both time points."|1-Month Follow-Up|"Analysis only included participants who completed the measure at both Baseline and 1-Month followup, in order to calculate match in preferences."|||Participants|||Count of Participants
2593152|NCT02248974|Secondary|Shared Decision-Making (SDM-9)|A brief patient-report instrument for measuring Shared Decision Making (SDM) in clinical encounters. All question items have a positive valence. Summing up all items leads to a raw total score between 0 and 45. Multiplication of the raw score by 20/9 provides a score forced (transformed) to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM. As it is more intuitively interpretable, the authors of the scale encourage the use of the transformed score, which we used.|1-Month Follow-Up|Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=25, no-DA=31, Total=56).|||units on a scale||Standard Deviation|Mean
2593348|NCT02246998|Secondary|PK Parameter: Cmax for TFV||"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the TFV PK Analysis Set (all treated participants who have respective, evaluable PK profiles of TFV) with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2593153|NCT02248974|Secondary|Shared Decision-Making (SDM-9)|A brief patient-report instrument for measuring Shared Decision Making (SDM) in clinical encounters. All question items have a positive valence. Summing up all items leads to a raw total score between 0 and 45. Multiplication of the raw score by 20/9 provides a score forced (transformed) to range from 0 to 100, where 0 indicates the lowest possible level of SDM and 100 indicates the highest extent of SDM. As it is more intuitively interpretable, the authors of the scale encourage the use of the transformed score, which we used.|1-Week Follow-Up|Analysis only includes participants who responded to measure at 1-Week Follow-Up (DA=27, no-DA=34, Total=61).|||units on a scale||Standard Deviation|Mean
2593154|NCT02248974|Secondary|Usability and Acceptability: Helped me Understand More About the Risks and Benefits of Treatment.|Measures the usability and acceptability of the decision aid 1 day after receiving the decision aid tool|1 Day Follow-up|Analysis included only those participants who completed this question in the 1-Day Follow-up measure, which was 35 patients in the DA group. The no-DA group did not receive the measure.|||Participants|||Count of Participants
2593155|NCT02248974|Secondary|Preparedness for Decision-Making Scale|The Preparedness for Decision-Making Scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation visit and making a health decision (treatment/diagnostic/screening, etc.). Items can be summed and scored (sum the 10 items and divide by 10). B) Scores are converted to a 0-100 scale by: subtracting 1 from the summed score in part a) and multiplying by 25. Higher scores indicate higher perceived level of preparation for decision-making.|1 Week Follow-up|Analysis only includes participants who responded to measure at 1-Week Follow-Up (DA=27, no-DA=33, Total=60).|||units on a scale||Standard Deviation|Mean
2593156|NCT02248974|Secondary|Satisfaction With Life Scale|Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.|1 Month Follow-up|Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=67).|||units on a scale||Standard Deviation|Mean
2593157|NCT02248974|Secondary|Satisfaction With Life Scale|Measures participants' perceived Satisfaction with Life. Out of 0-30 scale. Higher scores indicate higher satisfaction with life.|Baseline||||units on a scale||Standard Deviation|Mean
2593158|NCT02248974|Secondary|Ottawa Decision Regret Scale|"The 'Decision Regret Scale' measures distress or remorse after a (health care) decision. In a short introductory statement, respondents should be asked to reflect on a specific past decision, and then asked to indicate the extent to which they agree or disagree with the statements in the regret scale by indicating a number from 1 (Strongly Agree) to 5 (Strongly Disagree) that best indicates their level of agreement. Regret is measured at a point in time when the respondent can reflect on the effects of the decision. Items 2 and 4 should be reverse coded so that, for each item, a higher number will indicate more regret. To help others interpret the score more readily with other scales ranging from 0 to 100, these scores can then be converted to a 0-100 scale by subtracting 1 from each item then multiply by 25. To obtain a final score, the items are summed and averaged. A score of 0 means no regret; a score of 100 means high regret."|1 Month Follow-up|Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=67).|||units on a scale||Standard Deviation|Mean
2593159|NCT02248974|Secondary|Satisfaction With Decision Making Process|Measures a participant's satisfaction with their decision of treatment (at this time point: 1 month after baseline). All question items have a positive valence (higher scores indicating greater satisfaction with the decision making process, a more positive outcome), with scores ranging from 0-100.|1 Month Follow-up|Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=67).|||units on a scale||Standard Deviation|Mean
2593160|NCT02248974|Secondary|collaboRATE-Shared Decision Making|Measures a participant's perceived degree of shared decision-making about treatment (at this time point: 1 month after baseline). All question items have a positive valence (higher scores indicating greater shared decision-making, a more positive outcome), with scores ranging from 0-100.|1 Month Follow-up|Analysis only includes participants who responded to measure at 1-Month Follow-Up (DA=26, no-DA=31, Total=57).|||units on a scale||Standard Deviation|Mean
2593161|NCT02248974|Secondary|collaboRATE-Shared Decision Making|Measures a participant's perceived degree of shared decision-making about treatment (at this time point: 1 week after baseline). All question items have a positive valence (higher scores indicating greater shared decision-making, a more positive outcome), with scores ranging from 0-100.|1 Week Follow-up|Analysis only includes participants who responded to the measure at 1-Week Follow-Up (DA=28, no-DA=34, Total=62).|||units on a scale||Standard Deviation|Mean
2593162|NCT02248974|Secondary|Decisional Conflict Scale|Measures the construct of decisional conflict (at this timepoint, 1 week after baseline), using a 5-point Likert scale with 12 question items. All question items have a positive valence, with higher scores indicating lower decision conflict. Scores range from 0-100.|1 Week Follow-up|Analysis includes only those participants who completed the measure at Baseline (DA=29, no-DA=33, Total=62).|||units on a scale||Standard Deviation|Mean
2593163|NCT02248974|Secondary|Decisional Conflict Scale|Measures the construct of decisional conflict, using a 5-point Likert scale with 12 question items. All question items have a positive valence, with higher scores indicating lower decision conflict. Scores range from 0-100.|Baseline|Analysis includes only those participants who completed the measure at Baseline (DA=44, no-DA=50, Total=94).|||units on a scale||Standard Deviation|Mean
2593164|NCT02248974|Primary|Left Ventricular Assist Device (LVAD) Knowledge Scale|Questionnaire measuring subject's knowledge about Left Ventricular Assist Device therapy. Knowledge is reported on a scale from 1-100, with higher scores indicating greater knowledge. At this time-point, the scale measures LVAD knowledge at 1 month following both formal education (from the clinic) as well as from our decision aid about LVAD therapy.|1-Month Follow-up|Analysis only includes individuals who responded to the measure at 1-Week Follow-Up (DA=27, no-DA=31, Total=58).|||units on a scale||Standard Deviation|Mean
2593165|NCT02248974|Primary|Left Ventricular Assist Device (LVAD) Knowledge Scale|Questionnaire measuring subject's knowledge about Left Ventricular Assist Device therapy. Knowledge is reported on a scale from 1-100, with higher scores indicating greater knowledge. At this time-point, the scale measures LVAD knowledge at 1 week following both formal education (from the clinic) as well as from our decision aid about LVAD therapy.|1-Week Follow-up|Analysis only includes individuals who responded to the measure at 1-Week Follow-Up (DA=29, no-DA=34, Total=63).|||units on a scale||Standard Deviation|Mean
2593166|NCT02248974|Primary|Left Ventricular Assist Device (LVAD) Knowledge Scale|Questionnaire measuring subject's knowledge about Left Ventricular Assist Device therapy. Knowledge is reported on a scale from 1-100, with higher scores indicating greater knowledge. At Baseline, this scale measures LVAD knowledge before patients receive any formal education (from their LVAD coordinators and/or physicians) about LVAD therapy.|Baseline||||units on a scale||Standard Deviation|Mean
2593167|NCT02248961|Secondary|Number of Subjects Who Responded on Therapy|The subject will be considered a responder if SBP (when seated) <140 mmHg or SBP decrease is >10% from baseline.|Week 12 of treatment|Full Analysis Set Population (FAS) - those subjects from Intent-to-treat population (ITT, all randomized patients), who had at least one assessment for efficacy analysis after the start of therapy. Last observation carried forward (LOCF) imputation method.|||Participants|||Count of Participants
2593168|NCT02248961|Secondary|Change in SBP After 8 Weeks of Treatment|"The value of SBP( seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.~Change was calculated as (Value of SBP at week 8 minus Value of SBP at baseline)."|Baseline and week 8 of treatment|One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 8|||mm Hg||Standard Deviation|Mean
2593169|NCT02248961|Secondary|Change in SBP After 4 Weeks of Treatment|"The value of SBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.~Change was calculated as (Value of SBP at week 4 minus Value of SBP at baseline)."|Baseline and week 4 of treatment|One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 4|||mm Hg||Standard Deviation|Mean
2593170|NCT02248961|Secondary|Change in DBP After 12 Weeks of Treatment|"The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.~Change was calculated as (Value of DBP at week 12 minus Value of SBP at baseline)."|Baseline and week 12 of treatment|One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 12|||mm Hg||Standard Deviation|Mean
2593171|NCT02248961|Secondary|Change in DBP After 8 Weeks of Treatment|"The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.~Change was calculated as (Value of DBP at week 8 minus Value of SBP at baseline)."|Baseline and week 8 of treatment|All randomized patients, who had at least one assessment for efficacy analysis after the start of therapy. One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 8.|||mm Hg||Standard Deviation|Mean
2593172|NCT02248961|Secondary|Change in Diastolic Blood Pressure (DBP) After 4 Weeks of Treatment|"The value of DBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.~Change was calculated as (Value of DBP at week 4 minus Value of SBP at baseline)."|Baseline and week 4 of treatment|All randomized patients, who had at least one assessment for efficacy analysis after the start of therapy. One patient (Kanarb (fimasartan) treatment group) was withdrawn from the study by the time of assessment at week 4.|||mm Hg||Standard Deviation|Mean
2593173|NCT02248961|Primary|Change in Systolic Blood Pressure (SBP) After 12 Weeks of Treatment|"The value of SBP (seated) to be registered was mean of the 3 measurements performed with interval no less than 1 minute using the manual (mercury or mechanic) tonometer after 5 minutes rest.~Change was calculated as (Value of SBP at week 12 minus Value of SBP at baseline)."|Baseline and week 12 of treatment|Full Analysis Set Population (FAS) - those subjects from Intent-to-treat population (ITT, all randomized patients), who had at least one assessment for efficacy analysis after the start of therapy. Last observation carried forward (LOCF) imputation method.|||mm Hg||Standard Deviation|Mean
2593174|NCT02248922|Secondary|Change of Colony-forming Units (CFU) Between Week 4 (End of Study Drug Inhalation in the Current Treatment Cycle) and Week 8 (Prior to Start of Study Drug Inhalation in the Following Treatment Cycle)|Microbacterial density of Pseudomonas aeruginosa in Sputum-Samples in CFU (Colony Forming Units) per gram sputum.|week 4, week 8|Safety Set consisted of All 17 patients (in both arms: TIS and TIP) that entered the study and had been exposed to at least one dose of study drug. The efficacy analysis was based on safety set of Tobramycin ALL and not for each separate dosage form arm. n is the number of patients of safety set with a non-missing value at the specific time point.|||CFU per gram sputum||Standard Error|Least Squares Mean
2593175|NCT02248922|Secondary|Change of Forced Expiratory Volume at 1 Second(FEV1) Between Week 4 (End of Study Drug Inhalation in the Current Treatment Cycle) and Week 8 (Prior to Start of Study Drug Inhalation in the Following Treatment Cycle)|Change of FEV1 (Forced expiry volume in the first second) measured by Spirometry|week 4, week 8|Safety Set consisted of All 17 patients (in both arms: TIS and TIP) that entered the study (provided informed consent) and had been exposed to at least one dose of study drug. The efficacy analysis was based on safety set of Tobramycin ALL and not for each separate dosage form arm.|||% predicted||Standard Error|Least Squares Mean
2593176|NCT02248922|Secondary|Change of Lung Clearance Index (LCI) Between Week 4 (End of Study Drug Inhalation in the Current Treatment Cycle) and Week 8 (Prior to Start of Study Drug Inhalation in the Following Treatment Cycle)|The Lung Clearance Index (LCI), measured by Multiple Breath Washout of a tracer gas reflects the obstruction of airways in the lung. Wash-out was completed by definition at the time point when the inhaled gas concentration declined to 2.5% of its concentration at baseline. Washout took longer in patients with more severe disease as gas was trapped in narrowed airways (leading to a higher LCI). A LCI of 7.5 and below is normal.|week 4, week 8|Safety Set consisted of All 17 patients (in both arms: TIS and TIP) that entered the study (provided informed consent) and had been exposed to at least one dose of study drug. The efficacy analysis was based on safety set of Tobramycin ALL and not for each separate dosage form arm.|||Units on a scale||Standard Error|Least Squares Mean
2593201|NCT02248818|Primary|Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 MAD Day 12 Dose of AZD8108|Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 MAD Day 12 dose of AZD8108 Cohort 5 & 7, Cohort 6 did not reach Day 12|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48, 72 hr after Day 12 dose|Pharmacokinetic Population (those dosed with AZD8108)|||hours*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2593177|NCT02248922|Secondary|Change From Baseline in Lung Clearance Index (LCI) After 1 Week|The Lung Clearance Index (LCI), measured by Multiple Breath Washout of a tracer gas reflects the obstruction of airways in the lung. Wash-out was completed by definition at the time point when the inhaled gas concentration declined to 2.5% of its concentration at baseline. Washout took longer in patients with more severe disease as gas was trapped in narrowed airways (leading to a higher LCI). A LCI of 7.5 and below is normal.|Baseline, week 1|Safety Set consisted of All 17 patients (in both arms: TIS and TIP) that entered the study (provided informed consent) and had been exposed to at least one dose of study drug. The efficacy analysis was based on safety set of Tobramycin ALL and not for each separate dosage form arm.|||units on a scale||Standard Error|Least Squares Mean
2593178|NCT02248922|Secondary|Change From Baseline of Colony-forming Units (CFU) After 4 Weeks Following Onset of Study|Microbacterial density of Pseudomonas aeruginosa in Sputum-Samples in CFU (Colony Forming Units) per gram sputum.|Baseline, week 4|Safety Set consisted of All 17 patients (in both arms: TIS and TIP) that entered the study and had been exposed to at least one dose of study drug. The efficacy analysis was based on safety set of Tobramycin ALL and not for each separate dosage form arm. n is the number of patients of safety set with a non-missing value at the specific time point.|||CFU per gram sputum||Standard Error|Least Squares Mean
2593179|NCT02248922|Secondary|Change From Baseline of Forced Expiratory Volume at 1 Second (FEV1) After 4 Weeks Following Onset of Study|Change of FEV1 (Forced expiry volume in the first second) measured by Spirometry|Baseline, week 4|Safety Set consisted of All 17 patients (in both arms: TIS and TIP) that entered the study (provided informed consent) and had been exposed to at least one dose of study drug. The efficacy analysis was based on safety set of Tobramycin ALL and not for each separate dosage form arm.|||% predicted||Standard Error|Least Squares Mean
2593180|NCT02248922|Primary|Change From Baseline in Lung Clearance Index (LCI) After 4 Weeks Following Onset of Study|The Lung Clearance Index (LCI), measured by Multiple Breath Washout of a tracer gas reflects the obstruction of airways in the lung. Wash-out was completed by definition at the time point when the inhaled gas concentration declined to 2.5% of its concentration at baseline. Washout took longer in patients with more severe disease as gas was trapped in narrowed airways (leading to a higher LCI). A LCI of 7.5 and below is normal.|Baseline, week 4|Safety Set consisted of All 17 patients (in both arms: TIS and TIP) that entered the study (provided informed consent) and had been exposed to at least one dose of study drug. The efficacy analysis was based on safety set of Tobramycin ALL and not for each separate dosage form arm.|||units on a scale||Standard Error|Least Squares Mean
2593181|NCT02248857|Other Pre-specified|Changes in Low-density Lipoprotein Cholesterol (LDL)|An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Low-density lipoprotein cholesterol (LDL) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).|6 months before baseline to 1 year after baseline|All participants with both a baseline and 6 month LDL measurement|||mg/dL||Standard Deviation|Mean
2593182|NCT02248857|Other Pre-specified|Changes in Hemoglobin A1c (hbA1c)|An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Hemoglobin A1c (hbA1c) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).|6 months before baseline to 1 year after baseline|All participants with both a baseline and 6 month hbA1c measurement|||percent of glycated hemoglobin||Standard Deviation|Mean
2593183|NCT02248857|Other Pre-specified|Changes in Blood Pressure|An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Systolic blood pressure will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).|6 months before baseline to 1 year after baseline|All participants with both a baseline and 6 month systolic blood pressure measurement|||mmHG||Standard Deviation|Mean
2593184|NCT02248857|Secondary|Medication Adherence: Pharmacy Records|Predictive probabilities of primary medication adherence will be calculated based on the proportion of days covered (PDC) with medication obtained from pharmacy records using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. PDC is calculated by summing the number of days' supply obtained by a patient during a given time period and dividing by the number of days for which the patient was prescribed the medication. Each medication is scored as adherent if the patient was covered for that medication more than 80% of the time. Results are presented as predicted probabilities with 95% Confidence Intervals.|6 months after baseline|Participants who filled medications at Walgreens during the study period.|||Probability of adherence|Medications|95% Confidence Interval|Least Squares Mean
2593185|NCT02248857|Secondary|Medication Adherence: PMAQ|Predictive probabilities of medication adherence will be calculated based on a 4-item validated Patient Medication Adherence Questionnaire (PMAQ) using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. The PMAQ assesses adherence behaviors by asking patients to self-report missed/wrong doses in past 4 days, scoring each medication as adherent for that medication if no missed doses were reported. Results are presented as predicted probabilities with 95% Confidence Intervals.|6 months after baseline|All participants who completed the 6 month assessment and had complete outcome data for at least 1 medication|||Probability of adherence|Medications|95% Confidence Interval|Least Squares Mean
2593186|NCT02248857|Secondary|Medication Adherence: Pill Count|Predictive probabilities of medication adherence will be calculated based on telephone pill counts using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Pills taken/pills prescribed will be calculated for each medication and scored as adherent for that medication if that score is between 80% and 120%. Results are presented as predicted probabilities with 95% Confidence Intervals.|6 months after baseline|All participants who completed the 6 month assessment and had complete outcome data for at least 1 medication|||Probability of adherence|Medications|95% Confidence Interval|Least Squares Mean
2593187|NCT02248857|Secondary|Medication Knowledge|Predictive probabilities of medication knowledge will be calculated based on patients' ability to identify each medication's purpose and side effects, risks, warnings, and benefits using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Patients will be asked through a structured questionnaire about each of the above via structured, open-ended items. Each medication will be scored as correct/incorrect if the participant knew the purpose and could name at least 1 side effect, risk, or warning of the medication. Results are presented as predicted probabilities with 95% Confidence Intervals.|6 months after baseline|All participants who completed the 6 month assessment and had complete outcome data for at least 1 medication|||Probability of medication knowledge|Medications|95% Confidence Interval|Least Squares Mean
2593188|NCT02248857|Primary|Prescription Understanding|Predictive probabilities of prescription understanding will be calculated based on patients' ability to correctly dose their prescription medications using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Correct dosing per medication will be scored as yes or no, reflecting having demonstrated all of the following: proper dose (# of pills), spacing (hours between doses), frequency (# of times per day), and total pills per day. Results are presented as predicted probabilities with 95% Confidence Intervals.|6 months after baseline|All participants who completed the 6 month assessment and had complete data for the outcome for at least 1 medication.|||Probability|Medications|95% Confidence Interval|Least Squares Mean
2593189|NCT02248818|Other Pre-specified|EEG Parameter (DAY 12) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed) - Consistent Change in Either Direction|EEG parameter (DAY 12) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 & 7 , Cohort 6 did not reach Day 12; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo would be of interest|8 hours after dose|Safety population|||uV2||Standard Deviation|Mean
2593190|NCT02248818|Other Pre-specified|EEG Parameter (DAY 6) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction|EEG parameter (DAY 6) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) Cohort 5 & 7, Cohort 6 did not reach Day 6; to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction compared to placebo was of interest|8 hours after dose|Safety population|||uV2||Standard Deviation|Mean
2593191|NCT02248818|Other Pre-specified|EEG Parameter (DAY 1) - Gamma - Change From Baseline in Total Area of the Brain (Eyes Closed)- Consistent Change in Either Direction|EEG parameter (DAY 1) - Gamma - Change from baseline in Total Area of the Brain (eyes closed) - to identify a dose related change in EEG gamma bands to assess target engagement, a consistent change in either direction relative to placebo would be of interest|8 hours after dose|Safety population|||uV2||Standard Deviation|Mean
2593192|NCT02248818|Secondary|Pharmacokinetic: Accumulation Index for Area Under Concentration Curve (0 to 24 Hour) MAD|Pharmacokinetic: Accumulation index for Area Under Concentration Curve (0 to 24 hour) MAD Cohorts 5 & 7, cohort 6 did not reach day 12 [accumulation index (Day 6 or 12 /Day1)]|Day 12 compared to Day 1|Pharmacokinetic population, MAD Cohorts 5 & 7|||ratio||Standard Deviation|Mean
2593193|NCT02248818|Secondary|Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Day 12 (MAD) Dose of AZD8108|Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after Day 12 (MAD) dose AZD8108 Cohorts 5 & 7, Cohort 6 did not reach day 12|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hours after Day 12 dose|Pharmacokinetic population (subjects dosed with AZD8108)|||hours||Full Range|Median
2593194|NCT02248818|Secondary|Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (MAD) After Day 12 Dose of AZD8108|Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (MAD) after Day 12 dose of AZD8108 Cohorts 5 & 7, Cohort 6 did not reach day 12|Collection 0-6, 0-12, 12-24, 24-48, 48-72 hr after Day 12 dose|Pharmacokinetic Population (Cohorts 1-3) AZD8108 dosed|||Percent||Geometric Coefficient of Variation|Geometric Mean
2593195|NCT02248818|Secondary|Pharmacokinetic: Fraction of Equivalent Dose of AZD6765 Excreted in Urine (SAD) After Single Dose of AZD8108|Pharmacokinetic: Fraction of equivalent dose of AZD6765 excreted in urine (SAD) after single dose of AZD8108 (Cohorts 1 - 3)|Collection 0-6, 6-12,12-24, 24-48, (48-72 SAD only) hy after Day 1 dose|Pharmacokinetic Population (Cohorts 1-3) AZD8108 dosed|||Percent|Participants with urine volume data|Geometric Coefficient of Variation|Geometric Mean
2593196|NCT02248818|Secondary|Pharmacokinetic: Time to Maximum Plasma Concentration of AZD6765 After Single (SAD)/ 1st (MAD) Dose of AZD8108|Pharmacokinetic: Time to Maximum plasma concentration of AZD6765 after single (SAD) / first (MAD) dose AZD8108|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,(72 SAD only) hr after day 1 dose|Pharmacokinetic population (subjects dosed with AZD8108)|||hours||Full Range|Median
2593197|NCT02248818|Primary|Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 12 Dose of AZD8108|Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 12 dose of AZD8108, Cohorts 5 & 7, Cohort 6 did not reach Day 12|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24,48,72 hr after Day 12 dose|Pharmacokinetic Population (those dosed with AZD8108) MAD cohorts 5 & 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2593198|NCT02248818|Primary|Pharmacokinetic : Maximum Concentration of AZD6765 After MAD Day 6 Dose of AZD8108|Pharmacokinetic : Maximum concentration of AZD6765 after MAD Day 6 dose of AZD8108, Cohorts 5 & 7, Cohort 6 did not reach Day 6|Pre-dose, 5,15.30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose|Pharmacokinetic Population (those dosed with AZD8108) MAD cohorts 5 & 7|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2593199|NCT02248818|Primary|Pharmacokinetic : Maximum Concentration of AZD6765 After Single/1st Dose of AZD8108|Pharmacokinetic : Maximum concentration of AZD6765 after single/first dose of AZD8108|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,25,48,972 SAD only)hr after Day 1 dose|Pharmacokinetic Population (those dosed with AZD8108)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2593200|NCT02248818|Primary|Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hours), AZD6765 After DAY 12 Dose of AZD8108|Pharmacokinetic : Area under the concentration curve (0 to 24 hours), AZD6765 after Day 12 dose of AZD8108 cohort 5 & 7, Cohort 6 dod not reach Day 12|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16, and 24 hours after dose|Pharmacokinetic Population (those dosed with AZD8108)|||hours*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2593202|NCT02248818|Primary|Pharmacokinetic :Area Under the Concentration Curve (0 to 24 Hour), AZD6765 MAD Day 6 Dose of AZD8108|Pharmacokinetic : Area under the concentration curve (0 to 24 hour), AZD6765 MAD Day 6 dose of AZD8108 Cohort 5 & 7, Cohort 6 did not reach Day 6|Pre-dose, 5,15,30 min, 1,1.5,2,3,4,6,8,10,12,16,24 hr after Day 6 dose|Pharmacokinetic Population (those dosed with AZD8108)|||hours*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2593203|NCT02248818|Primary|Pharmacokinetic :Area Under the Concentration Curve (0 to Infinity), AZD6765 After Single/1st Dose of AZD8108|Pharmacokinetic : Area under the concentration curve (0 to infinity), AZD6765 after single/first dose of AZD8108|Pre-dose,5,15,30 min, 1,1.5,2,3,4,6,8,10,12,14,16,24,48,(72 SAD only) hr after day 1 dose|Pharmacokinetic Population (those dosed with AZD8108)|||hours*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2593204|NCT02248818|Primary|Safety Laboratory - Thyroid Stimulating Hormone Above Upper Limit of Normal|Safety Laboratory - Thyroid Stimulating Hormone participants with laboratory value above the upper limit of normal|Day -1 to 7 days after last dose|Safety population|||Participants|||Number
2593205|NCT02248766|Primary|Subjective Assessments- Enfilcon A and Somofilcon A|Subjective assessments for: comfort, dryness, handling, overall lens fit, and overall vision satisfaction. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall lens fit (0=very unstable; 10=very stable), overall vision satisfaction (0=very unsatisfied; 10=very satisfied)|Baseline, 1 week, 2 week, 4 week||||units on a scale||Standard Deviation|Mean
2593206|NCT02248766|Primary|Visual Acuity - Enfilcon A and Somofilcon A|Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.|Baseline, 1 week, 2 week, 4 week||||logMar||Standard Deviation|Mean
2593207|NCT02248740|Other Pre-specified|Incidence of Pain and Bruising|"Measurement of pain will be performed by patient solicitation of pain rating on a scale of 0 to 10.~Bruising will be measured on a scale of 0-10, determined by a consensus of all study investigators."|During Intervention and post procedure recovery period in clinic, an expected average of 2 hours.|No study data was collected prior to study termination.||||||
2593208|NCT02248740|Secondary|Incidence Rate of Acute Complications||1 and 6 weeks post intervention.|No study data was collected prior to study termination.||||||
2593209|NCT02248740|Primary|Number of Participants With Recurrent Clinical Symptoms of an Incompetent Small Saphenous Vein After Treatment.||At 10 years after treatment.|No study data was collected prior to study termination.||||||
2593210|NCT02248727|Primary|Subjective Assessments. - Enfilcon A and Somofilcon A|Subjective assessments for: comfort, dryness, handling, overall vision satisfaction, and eye whiteness. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall vision satisfaction (0=very unsatisfied; 10=very satisfied), habitual eye whiteness (0=not white; 10= totally white)|Baseline, 1 Week, 2 Week, 4 Week||||units on a scale||Standard Deviation|Mean
2593211|NCT02248727|Primary|Visual Acuity - Enfilcon A and Somofilcon A|Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.|Baseline, 1 Week, 2 Week, 4 Week||||logMar||Standard Deviation|Mean
2593212|NCT02248714|Secondary|Change From Baseline in HOMA-IR|the change of HOMA-IR between the end and the beginning of the study|4 weeks|The analysis population is subjects who completed the whole study.|||mU/L*mmol/L||Standard Deviation|Mean
2593213|NCT02248714|Secondary|Change From Baseline in GA|the change of GA between the end and the beginning of the study|4 weeks|The analysis population is subjects who completed the whole study.|||percentage of GA||Standard Deviation|Mean
2593214|NCT02248714|Secondary|Change From Baseline in HbA1c|the change of HbA1c between the end and the beginning of the study|4 weeks|The analysis population is subjects who completed the whole study.|||percentage of HbA1c||Standard Deviation|Mean
2593215|NCT02248714|Secondary|Change From Baseline in 2h-PG|the change of 2h-PG between the end and the beginning of the study|4 weeks|The analysis population is subjects who completed the whole study.|||mmol/L||Standard Deviation|Mean
2593216|NCT02248714|Secondary|Change From Baseline in FPG|the change of FPG between the end and the beginning of the study|4 weeks|The analysis population is subjects who completed the whole study.|||mmol/L||Standard Deviation|Mean
2593217|NCT02248714|Secondary|Change From Baseline in LDL-c|the change of LDL-c between the end and the beginning of the study|4 weeks|The analysis population is subjects who completed the whole study.|||mmol/L||Standard Deviation|Mean
2593218|NCT02248714|Secondary|Change From Baseline in HDL-c|the change of HDL-c between the end and the beginning of the study|4 weeks|The analysis population is subjects who completed the whole study.|||mmol/L||Standard Deviation|Mean
2593219|NCT02248714|Secondary|Change From Baseline in Triglycerides|the change of triglycerides between the end and the beginning of the study|4 weeks|The analysis population is subjects who completed the whole study.|||mmol/L||Standard Deviation|Mean
2593220|NCT02248714|Secondary|Change From Baseline in TC|the change of total cholesterol between the end and the beginning of the study|4 weeks|The analysis population is subjects who completed the whole study.|||mmol/L||Standard Deviation|Mean
2593221|NCT02248714|Secondary|Change From Baseline in Diastolic Blood Pressure|the change of diastolic blood pressure between the end and the beginning of the study|4 weeks|The analysis population is subjects who completed the whole study.|||mmHg||Standard Deviation|Mean
2593222|NCT02248714|Secondary|Change From Baseline in Systolic Blood Pressure|the change of systolic blood pressure between the end and the beginning of the study|4 weeks|The analysis population is subjects who completed the whole study.|||mmHg||Standard Deviation|Mean
2593223|NCT02248714|Secondary|Change From Baseline in BMI|the change of BMI between the end and the beginning of the study|4 weeks|The analysis population is subjects who completed the whole study.|||kg/m2||Standard Deviation|Mean
2593238|NCT02248558|Primary|First-Time HIV Testing|All individuals enrolled in the study will receive a cell phone text message three weeks later asking if they have received an HIV test. Among those individuals who do not respond to the text message, another text will be sent at four weeks after the video. We anticipate the median duration of follow-up to be approximately 3.5 weeks following the video intervention.|Up to 4 weeks following the video intervention||||Participants|||Count of Participants
2593224|NCT02248714|Primary|Change From Baseline in Glucose Coefficient of Variation(CV)|Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and glucose coefficient of variation(CV) will be calculated based on CGMS data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings.|4 weeks|The analysis population is subjects who completed the whole study.|||percentage of CV||Standard Deviation|Mean
2593225|NCT02248714|Primary|Change From Baseline in MAGE|Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and MAGE will be calculated based on CGMS data.|4 weeks|The analysis population is subjects who completed the whole study.|||mmol/L||Standard Deviation|Mean
2593226|NCT02248714|Primary|Change From Baseline in SDBG|Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and SDBG will be calculated based on CGMS data.|4 weeks|The analysis population is subjects who completed the whole study.|||mmol/L||Standard Deviation|Mean
2593227|NCT02248714|Primary|Change From Baseline in AUCpp|Subjects will perform continues blood glucose monitoring using CGMS for 72 hours at the beginning of the study and within the last three days during a 4-week treatment interval and AUCpp based on CGMS data was calculated as the area between the glucose concentration-time curve, and the pre-prandial baseline glucose value measured at 4 h after each meal.|4 weeks|The analysis population is subjects who completed the whole study.|||min*mmol/L||Standard Deviation|Mean
2593228|NCT02248675|Secondary|Insomnia Severity Index (ISI)|A well-validated 7-item self-report measure developed to assess insomnia severity; higher scores are associated with greater severity (range of 0-28 with higher scores indicating greater insomnia severity).|post-treatment (~6-8 weeks)||||units on a scale||Standard Deviation|Mean
2593229|NCT02248675|Secondary|Patient Health Questionnaire-9 (PHQ-9)|A well-validated 9-item self-report measure developed to assess depression severity; higher scores are associated with greater severity (range of 0-27 with higher scores indicating more severe depression severity).|post-treatment (~6-8 weeks)||||units on a scale||Standard Deviation|Mean
2593230|NCT02248675|Secondary|Perceived Treatment Beliefs (PTS)|A 21-item measure (with items ranging from 1-7) based on the theory of planned behavior and designed to assess beliefs about treatment and plans to engage in treatment in military populations. This measure will focus on engagement in PTSD and depression treatments. The total score has a range of 21-147 with higher scores indicating higher likelihood of engaging in care.|post-treatment (~6-8 weeks)||||units on a scale||Standard Deviation|Mean
2593231|NCT02248675|Primary|Columbia Suicide Severity Rating Scale (C-SSRS)|The entire Columbia Suicide Severity Rating Scale (C-SSRS) will be administered, but the investigators will use its' Suicidal Ideation Intensity scale (0-25 score range summed from five items, with higher scores indicating more severe suicidal ideation) as the primary outcome.|post-treatment (~6-8 weeks)||||units on a scale||Standard Deviation|Mean
2593232|NCT02248662|Primary|Association Between Patient Characteristics and Three-Level Cluster of Treatment Intensity for Primary DCIS|"The investigators defined treatment intensity in a health services area to be the proportion of patients undergoing breast conserving surgery for DCIS who receive radiation therapy. Because a proportion is challenging to analyze statistically given that the precision of the estimate depends on the size of the denominator which varies across service areas, we used hierarchical modeling to categorize the health service areas into three categories (low, medium, high), using a latent variable to determine which health service area belongs to each of the three categories. The cutoffs separating the groups were based on the hierarchical model, taking the precision of the estimated proportion of patients receiving radiation into account. Health service areas with the highest proportions of patients receiving radiation were assigned to the high cluster; those with the lowest proportions to the low cluster; and those in the between to the medium cluster."|20 Years||||Participants|||Count of Participants
2593233|NCT02248649|Secondary|Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 18|The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 12-month - Score at Baseline.|Baseline and 18 month|number of participants analyzed: participants with ADAS-Cog scores at baseline and at 18 months. 21 participants in Physical Activity group and 21 participants in Control group did not have a score at 18 months.|||units on a scale||Standard Error|Mean
2593234|NCT02248649|Secondary|Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 12|The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 12-month - Score at Baseline.|Baseline and 12 months|number of participants analyzed: participants with ADAS-Cog scores at baseline and at 12 months. 17 participants in Physical Activity group and 15 participants in Control group did not have a score at 12 months.|||units on a scale||Standard Error|Mean
2593235|NCT02248649|Primary|Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 6|The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 6-month - Score at Baseline.|Baseline and 6 months|number of participants analyzed: participants with ADAS-Cog scores at baseline and at 6 months. 4 participants in Physical Activity group and 6 participants in Control group did not have a score at 6 months.|||score on a scale||Standard Error|Mean
2593236|NCT02248558|Secondary|Cost-effectiveness of Developing HIV Testing Promotional Videos|Cost-effectiveness of developing the crowdsourced video compared to the conventional video|Up to one year||||USD|||Number
2593237|NCT02248558|Secondary|Likelihood of HIV Testing|"All individuals will be asked how likely they are to test for HIV soon immediately before and after watching the videos (during enrollment). Likelihood of HIV testing will be measured on a 4-point numerical Likert scale rating scale. 0 will be very unlikely, 1 will be unlikely, 2 will be likely, and 3 will be very likely. The percentage of individuals who report increased likelihood of HIV testing will be reported."|Up to one day||||Participants|||Count of Participants
2593349|NCT02246998|Secondary|PK Parameter: t1/2 for RTV||"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the RTV PK Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
2593239|NCT02248480|Secondary|Change From Baseline on the WOMAC Questionnaire Physical Function Subscale|The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The physical function subscale rates participant pain during stair use, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of the bath, sitting, getting on/off the toilet, heavy household duties, and light household duties. Each question was answered using a 5-point Likert scale (0 to 4). Physical Function Subscale has a range of scores of 0 (none) to 68 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.|Baseline, 14 Weeks|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2593240|NCT02248480|Secondary|Change From Baseline on the WOMAC Questionnaire Stiffness Subscale|The WOMAC index (pain, stiffness, physical function subscales) will be completed by the participant.The stiffness subscale had 2 questions on stiffness associated with time of day (morning versus later in the day). Each question was answered using a 5-point Likert scale (0 to 4). The stiffness subscale has a range of scores of 0 (none) to 8 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.|Baseline, 14 Weeks|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2593241|NCT02248480|Secondary|Change From Baseline on the WOMAC Questionnaire Pain Subscale|The WOMAC index (pain, stiffness, physical function subscales) was completed by the participant.The pain subscale had 5 questions on pain associated with every day tasks. Each question was answered using a 5-point Likert scale (0 to 4). The pain subscale has a range of scores of 0 (none) to 20 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, baseline data as covariates.|Baseline, 14 Weeks|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2593242|NCT02248480|Secondary|Percentage of Participants With a Responder Rate Based on OMERACT-OARSI Criteria|A responder is required to meet at least one condition: reduction of ≥50% and ≥2 score in Weekly Mean of the 24-Hour Average Pain Score, reduction of ≥50% or ≥13.6 score in WOMAC (difficulty in dairy activity) and meet ≥2 out of following 3 conditions: reduction of ≥20% and ≥1 score in Weekly Mean of the 24-Hour Average Pain, reduction of ≥20% and ≥6.8 score in WOMAC (difficulty in dairy activity), PGAI score ≥2.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.|||percentage of participants|||Number
2593243|NCT02248480|Secondary|Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score|Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine).|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.|||percentage of participants|||Number
2593244|NCT02248480|Secondary|Change From Baseline on Weekly Mean of the 24-Hour Average Pain and Worst Pain Score|24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain and worst pain within 24-hours. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2593245|NCT02248480|Secondary|Percentage of Participants With a 30% and 50% Reduction in Average Pain Score on Weekly Mean of the 24-Hour Average Pain Score on the 11-Point Numeric Rating Scale|24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain within 24-hours.|Baseline,Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.|||percentage of participants|||Number
2593246|NCT02248480|Secondary|Change in Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S, BPI-I) Change From Baseline in BPI Pain Severity Items and Interference Items Score|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2593257|NCT02248246|Secondary|Percentage of Participants With Hemostasis at the IMV|"Hemostasis of the IMV is a dichotomous variable (i.e. yes or no). Yes is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMV."|Intraoperatively|Safety Set - all subjects in whom the procedure was started.|||percentage of participants||95% Confidence Interval|Number
2594358|NCT02233738|Secondary|Social Support Survey Total Score at 6 Months|Min value:19 Max value:95 Higher score indicates higher support|90 days prior to 6-month follow-up||||score on a scale||Standard Deviation|Mean
2593247|NCT02248480|Secondary|Change From Baseline on the 5 Dimension (EQ-5D) Version of the European Quality of Life Instrument|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument and was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1, with the higher score indicating a better health state perceived by the participant. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm. Least squares (LS) mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline data as covariate.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.|||units on a scale||Standard Error|Least Squares Mean
2593248|NCT02248480|Secondary|Change From Baseline on the Patient Global Assessment Illness (PGAI) Score||Baseline, Week 14|Zero participants analyzed. PGAI outcome measure was registered incorrectly thus no analysis produced.||||||
2593249|NCT02248480|Secondary|Change From Baseline on the Western Ontario and McMaster Osteoarthritis Index (WOMAC) Questionnaire Total Score|The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC total score was calculated for each participant at each time point for analysis as the mean total score, range 0 (none) -96 (extreme). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2593250|NCT02248480|Secondary|Percentage of Participants With Fall Events From Fall Questionnaire|Participants evaluated their experience with and details of falls which were recorded.|Baseline through Week 14|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2593251|NCT02248480|Secondary|Change From Baseline on the Beck Depression Inventory (BDI-II) Total Score|Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe. Least squares (LS) mean was calculated using a ANCOVA approach' including administration groups as fixed effects, and baseline data as covariate.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.|||units on a scale||Standard Error|Least Squares Mean
2593252|NCT02248480|Secondary|Change From Baseline on the 36-Item Short-Form Health Survey (SF-36)|36-item Short-Form Health Survey: SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-15); social functioning (range: 2-10); bodily pain (range: 2-12); vitality (range: 4-20); mental health (range: 5-25). Each raw scale score was converted to a scale score ranging from 0-100 points, , with higher values representing a better outcome [(Raw score) − min{raw score}] / (max {raw score} − min{raw score}) x 100]. Least squares (LS) mean was calculated using Analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and baseline data as covariate.|Baseline, Week 14|All participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment. The last observation carried forward (LOCF) was used.|||units on a scale||Standard Error|Least Squares Mean
2593253|NCT02248480|Secondary|Change From Baseline on the Clinical Global Impression of Severity (CGI-S)|CSI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and baseline data as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2593254|NCT02248480|Secondary|Change From Baseline in Patient Global Impression of Improvement (PGI-Improvement)|Patient's Global Impressions of Improvement Scale: PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and PGI-severity at baseline as covariates.|Baseline, 14 Weeks|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2593255|NCT02248480|Primary|Change From Baseline on the Brief Pain Inventory (BPI) 24-Hour Average Pain Score|Brief Pain Inventory Severity: Average Pain Score: A self-reported scale that measures the severity of pain based on the average pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups and observation points as fixed effects, and BPI average pain severity at baseline as covariates.|Baseline, Week 14|All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2593256|NCT02248285|Primary|Analysis of Diarrheal Illness Etiologies Identified in Stool Culture Compared to the FilmArray™ Gastrointestinal (GI) Panel|Describing of etiology of diarrheal illness in the study as identified by each method|Seven to ten days after enrollment||||Participants|||Count of Participants
2593258|NCT02248246|Primary|Percentage of Participants With Hemostasis at the IMA|"Hemostasis of the IMA is a dichotomous variable (i.e. yes or no). Yes is defined as a single activation of the Advanced Hemostasis Mode to transect and seal the IMA."|Intraoperatively|Safety Set - all subjects in whom the procedure was started.|||percentage of subjects||95% Confidence Interval|Number
2593259|NCT02248103|Secondary|Bone Defect Area|linear measurements collected from a digital radiography program to estimate percentage of defect fill.|Baseline and 6 months||||"mm^2"||Standard Deviation|Mean
2593260|NCT02248103|Secondary|Pocket Depth|Estimation of pocket depth in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration|Baseline and 6 months||||mm||Standard Deviation|Mean
2593261|NCT02248103|Primary|Clinical Attachment Level|Estimation of clinical attachment level in chronic periodontitis patients at baseline and 6 months after guided tissue regeneration|Baseline and 6 months|defects|||mm||Standard Deviation|Mean
2593262|NCT02247960|Secondary|Number of Participants With Bacteria in Urine|Bacterial cultures were performed on urine and the presence of the following bacteria was determined: Acinetobacter, Coagulase-negative staphylococci, Diptherioids, Escherichia coli, Enterobacter, Enterococcus, Klebsiella pneumonia, and Lactoferrin. Participants who were positive for one or more of these were considered positive.|3 months|10 participants in the Ciprofloxacin arm and 16 participants in the no antibiotic arm did not have samples collected for testing.|||Participants|||Count of Participants
2593263|NCT02247960|Secondary|Number of Participants Positive for Clostridium Difficile|Development of Clostridium difficile was measured in stool for clostridium difficile infection by enzyme immunoassay (EIA) and/or polymerase chain reaction (PCR).|3 months|this outcome measure was only collected on patients who had their catheter removed (ie. started period 2)|||Participants|||Count of Participants
2593264|NCT02247960|Primary|Number of Participants With a Positive Urinary Tract Infection|After removal of the catheter, urine was tested for infection whenever symptoms were experienced by the participants from the time they enrolled to 12 months following their operation.|12 months|this outcome measure was only collected on patients who had their catheter removed (ie. started period 2)|||Participants|||Count of Participants
2593265|NCT02247804|Secondary|Change From Baseline in IOP in the Study Eye|IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.|Baseline (Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2)|ITT population was defined as all randomized participants. Number analyzed is the number of participants with evaluable data at the given timepoint.|||mm Hg||Standard Error|Least Squares Mean
2593266|NCT02247804|Primary|IOP in the Study Eye at Week 12 (Hour 2)|IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.|Week 12 (Hour 2)|ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.|||mm Hg||Standard Error|Least Squares Mean
2593267|NCT02247804|Primary|IOP in the Study Eye at Week 12 (Hour 0)|IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.|Week 12 (Hour 0)|ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.|||mm Hg||Standard Error|Least Squares Mean
2593268|NCT02247804|Primary|IOP in the Study Eye at Week 6 (Hour 2)|IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.|Week 6 (Hour 2)|ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.|||mm Hg||Standard Error|Least Squares Mean
2593269|NCT02247804|Primary|IOP in the Study Eye at Week 6 (Hour 0)|IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.|Week 6 (Hour 0)|ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.|||mm Hg||Standard Error|Least Squares Mean
2593270|NCT02247804|Primary|IOP in the Study Eye at Week 2 (Hour 2)|IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.|Week 2 (Hour 2)|ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.|||mm Hg||Standard Error|Least Squares Mean
2593271|NCT02247804|Primary|IOP in the Study Eye at Week 2 (Hour 0)|IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.|Week 2 (Hour 0)|ITT population was defined as all randomized participants. Overall number of participants analyzed is the number of participants with data available for analyses.|||mm Hg||Standard Error|Least Squares Mean
2593272|NCT02247804|Primary|Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2)|IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.|Baseline (Hours 0 and 2) to Week 12 (Hours 0 and 2)|ITT population was defined as all randomized participants. Number analyzed is the number of participants with evaluable data at the given timepoint.|||millimeters of mercury (mm Hg)||Standard Error|Least Squares Mean
2593273|NCT02247765|Primary|SpO2 Accuracy During Motion Conditions - MaxN Sensor|For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root‐Mean‐Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxN sensor has a different bandage from the MaxA sensor, and therefore a different form and fit.|up to 6 months||||Accuracy Root Mean Square|||Number
2593274|NCT02247765|Primary|SpO2 Accuracy During Motion Conditions - MaxA Sensor|For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root‐Mean‐Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxA sensors has a different bandage from the MaxN sensor, and therefore a different form and fit.|up to 6 months||||Accuracy Root Mean Square|||Number
2593275|NCT02247739|Other Pre-specified|Immunogenicity|Number of participants analyzed for neutralizing C1INH-specific antibodies and neutralizing rhC1INH-specific antibodies after confirmed anti-C1INH and anti rhC1INH IgM or IgG antibodies|20 weeks|Participants analyzed for Neutralizing antibodies after confirmed testing of anti-C1INH and anti rhC1INH IgM or IgG antibodies. Count of participants displays the number of positives.|||Participants|||Count of Participants
2593276|NCT02247739|Secondary|Percentage of Participants Achieving at Least 50% Reduction in Number of Attacks|Percentage of participants achieving at least 50% reduction in the number of attacks normalized to a 28-day period as compared to the placebo treatment period|28 days|Both the rhC1INH twice weekly treatments and the rhC1INH once weekly treatment periods are compared to the placebo treatment for the safety population. One subject withdrew before receiving any treatment and is excluded from the analysis.|||percentage of participants||95% Confidence Interval|Number
2593277|NCT02247739|Secondary|Number of Participants With Adverse Events|Number of participants that experienced Treatment Emergent Adverse Events observed in safety population|20 weeks|Safety Population: All patients who received at least a partial injection of study drug. The statistical analyses are based on the actual treatment the patient received.|||Participants|||Count of Participants
2593278|NCT02247739|Primary|Number of HAE Attacks|Average number of HAE attacks normalized to a 28 day period|28 days|Intent-to-Treat (ITT) Population: All patients who were randomized into one of the treatment sequences. The statistical analyses are based on the treatments to which the patient was randomized to receive during that treatment period.|||attacks||95% Confidence Interval|Mean
2593279|NCT02247531|Primary|Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48|For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).|Baseline, Week 48|ITT population included all the participants who were randomized to the study. The analysis was done specifically for CFI-positive and negative participants.|||mm^2||Standard Error|Mean
2593280|NCT02247531|Secondary|Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48|The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence. A negative change from baseline indicates a decrease in the FRI; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.|Baseline, Week 48|ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.|||score on a scale||Standard Error|Mean
2593281|NCT02247531|Secondary|Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48|NEI-VFQ-25 questionnaire included 25 items based on which distance activities were measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the distance visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.|Baseline, Week 48|ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.|||score on a scale||Standard Error|Mean
2593282|NCT02247531|Secondary|Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48|NEI-VFQ-25 questionnaire included 25 items based on which near activities were measured. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the near visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.|Baseline, Week 48|ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.|||score on a scale||Standard Error|Mean
2593350|NCT02246998|Secondary|PK Parameter: λz for RTV||"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the RTV PK Analysis Set with available data were analyzed.|||1/hour||Standard Deviation|Mean
2593283|NCT02247531|Secondary|Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48|NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health, general vision, ocular pain, vision−specific social functioning, vision−specific mental health, vision−specific role difficulties, vision−specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale or total score is the average of items contributing to the score. For each subscale and total score the score range is 0 to 100 with a higher score representing better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.|Baseline, Week 48|ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.|||score on a scale||Standard Error|Mean
2593284|NCT02247531|Secondary|Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48|MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring reading acuity and reading speed of normal and low-vision participants. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. Reading test was stopped when reading time was longer than 20 seconds or when participant was making severe errors. A negative change from baseline indicates a decrease in the monocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.|Baseline, Week 48|ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.|||wpm||Standard Error|Mean
2593285|NCT02247531|Secondary|Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48|MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the binocular reading speed; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.|Baseline, Week 48|ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.|||words per minute (wpm)||Standard Error|Mean
2593286|NCT02247531|Secondary|Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48|Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.|Week 48|ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.|||percentage of participants|||Number
2593287|NCT02247531|Secondary|Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48|The low luminance visual acuity was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. A negative change from baseline indicates a decrease in the visual acuity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.|Baseline, Week 48|ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.|||letters||Standard Error|Mean
2593288|NCT02247531|Secondary|Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48|Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). Data were collected up to Week 48 instead of Week 96, due to early termination of the study.|Week 48|ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.|||percentage of participants|||Number
2593289|NCT02247531|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48|BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity; disease worsening.|Baseline, Week 48|ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.|||letters||Standard Error|Mean
2593290|NCT02247531|Secondary|Change From Baseline in Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48|Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A negative change from baseline indicates a decrease in the mean macular sensitivity; disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.|Baseline, Week 48|The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization). Participants analyzed in this outcome measure were those included in MMRM analysis.|||decibel (dB)||Standard Error|Mean
2593351|NCT02246998|Secondary|PK Parameter: AUCtau for RTV||"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the RTV PK Analysis Set with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
2593291|NCT02247531|Secondary|Change From Baseline in Number of Absolute Scotomatous Points Assessed by Mesopic Microperimetry at Week 48|Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening. Data were collected up to Week 48 instead of Week 96, due to early termination of the study.|Baseline, Week 48|The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization). Participants analyzed in this outcome measure were those included in MMRM analysis.|||number of absolute scotomatous points||Standard Error|Mean
2593292|NCT02247531|Primary|Change From Baseline in Geographic Atropy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48|The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).|Baseline, Week 48|Intent-to-treat (ITT) population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in Mixed-effect model repeated measures (MMRM analysis).|||millimeter square (mm^2)||Standard Error|Mean
2593293|NCT02247479|Primary|Change From Baseline in GA Area in Complement Factor I (CFI) Positive and Negative Participants at Week 48|For CFI profile, positive or negative biomarker status refers to the presence (carrier) or absence of the risk allele at CFI and at least one risk allele at complement factor H (CFH) or risk locus containing both complement component 2 and complement factor B (C2/CFB).The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).|Baseline, Week 48|ITT population included all the participants who were randomized to the study. The analysis was done specifically for CFI-positive and negative participants. Number analyzed for each row signifies the participants evaluated for specified categories for each reporting group.|||mm^2||Standard Error|Mean
2593294|NCT02247479|Secondary|Change From Baseline in Mean Functional Reading Independence (FRI) Index at Week 48|The FRI was an interviewer-administered questionnaire with 7 items on functional reading activities most relevant to GA AMD participants. It has one total index score. For each FRI Index reading activity performed in the past 7 days, participants were asked about the extent to which they required vision aids, adjustments in the activity, or help from another participant. Mean FRI Index scores range from 1 to 4, with higher scores indicating greater independence. A negative change from baseline indicates a decrease in the FRI; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.|Baseline, Week 48|ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.|||score on a scale||Standard Error|Mean
2593295|NCT02247479|Secondary|Change From Baseline in NEI VFQ-25 Distance Activity Subscale Score at Week 48|NEI-VFQ-25 questionnaire included 25 items based on which distance activities were measured. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the distance visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.|Baseline, Week 48|ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.|||score on a scale||Standard Error|Mean
2593296|NCT02247479|Secondary|Change From Baseline in NEI VFQ-25 Near Activity Subscale Score at Week 48|NEI-VFQ-25 questionnaire included 25 items based on which near activities were measured. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf. Response to each question converted to 0-100 score. Subscale=average of items contributing to score. For this subscale the score range is 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the near visual activities; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.|Baseline, Week 48|ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.|||score on a scale||Standard Error|Mean
2593297|NCT02247479|Secondary|Change From Baseline in National Eye Institute Visual Functioning Questionnaire 25-item (NEI VFQ-25) Version Composite Score at Week 48|NEI-VFQ-25 questionnaire included 25 items based on which overall composite VFQ score and 12 subscales were derived: near activities, distance activities, general health,general vision, ocular pain, vision−specific social functioning, vision−specific mental health, vision−specific role difficulties, vision−specific dependency, driving, color vision and peripheral vision. Response to each question converted to 0-100 score. Each subscale, total score=average of items contributing to score. For each subscale and total score, score range: 0 to 100, a higher score represents better functioning. A negative change from baseline indicates a decrease in the visual functioning; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.|Baseline, Week 48|ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.|||scores on a scale||Standard Error|Mean
2593323|NCT02247401|Secondary|Percentage of Participants With On-treatment Virologic Failure in Each Treatment Arm|On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with at least 6 weeks of treatment, confirmed HCV RNA greater than the LLOQ after previously having unquantifiable HCV RNA, or a confirmed increase from nadir of at least one log10 in HCV RNA during treatment.|Up to 12 or 24 weeks after first dose|Intent-to-treat population: all participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2593352|NCT02246998|Secondary|PK Parameter: Ctau for RTV||"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the RTV PK Analysis Set with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2593298|NCT02247479|Secondary|Change From Baseline in Monocular Maximum Reading Speed as Assessed by MNRead Charts or Radner Reading Charts at Week 48|MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the monocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.|Baseline, Week 48|ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.|||wpm||Standard Error|Mean
2593299|NCT02247479|Secondary|Change From Baseline in Binocular Reading Speed as Assessed by Minnesota Low-Vision Reading Test (MNRead) Charts or Radner Reading Charts at Week 48|MNRead acuity cards were continuous-text reading-acuity cards suitable for measuring the reading acuity and reading speed of normal and low-vision participants. The MNRead acuity cards consisted of single, simple sentences with equal numbers of characters. A stopwatch was used to record time to a tenth of a second. Sentences that could not be read or were not attempted due to vision should be recorded as 0 for time and 10 for errors. The Radner Reading Cards were suitable for measuring reading speed, reading visual acuity, and critical print size. The reading test was stopped when the reading time was longer than 20 seconds or when the participant was making severe errors. A negative change from baseline indicates a decrease in the binocular reading speed; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.|Baseline, Week 48|ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.|||words per minute (wpm)||Standard Error|Mean
2593300|NCT02247479|Secondary|Percentage of Participants With Less Than 15 Letters Loss From Baseline in LLVA Score at Week 48|Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 m. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.|Week 48|ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.|||percentage of participants||95% Confidence Interval|Number
2593301|NCT02247479|Secondary|Change From Baseline in Low Luminance Visual Acuity (LLVA) as Assessed by ETDRS Chart Under Low Luminance Conditions at Week 48|The LLVA was measured by placing a 2.0-log-unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. The assessment was performed prior to dilating the eyes. LLVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was collected up to Week 48 instead of Week 96, due to early termination of the study.|Baseline, Week 48|ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.|||letters||Standard Error|Mean
2593302|NCT02247479|Secondary|Percentage of Participants With Less Than 15 Letters Loss From Baseline in BCVA Score at Week 48|Loss of less than 15 letters from baseline was assessed by the ETDRS chart at a starting distance of 4 meters (m). BCVA was measured using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The data was collected up to Week 48 instead of Week 96, due to early termination of the study.|Week 48|ITT population included all the participants who were randomized to the study. Reported here is the number of participants for whom data were collected.|||percentage of participants||95% Confidence Interval|Number
2593303|NCT02247479|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Week 48|BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.|Baseline, Week 48|ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in MMRM analysis.|||letters||Standard Error|Mean
2593304|NCT02247479|Secondary|Change From Baseline in Mean Macular Sensitivity as Assessed by Mesopic Microperimetry at Week 48|Mesopic microperimetry was used to assess macular sensitivity and assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. A negative change from baseline indicates a decrease in the mean macular sensitivity; disease worsening. The data was collected up to Week 48 instead of Week 96, due to early termination of the study.|Baseline, Week 48|The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization). Participants analyzed in this outcome measure were those included in MMRM analysis.|||decibel (dB)||Standard Error|Mean
2593324|NCT02247401|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.|Screening until 30 days after last dose|Safety Population: all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593305|NCT02247479|Secondary|Change From Baseline in Number of Absolute Scotomatous Points as Assessed by Mesopic Micrometry at Week 48|Scotomatous points were the testing points on microperimetry examination that were centered on the macula and reported a lack of retinal sensitivity within the range tested, a maximum of 68 points were tested within this range. Higher results indicate expansion of absolute scotoma and higher number of abolute scotomatous points. Mesopic microperimetry assessments were performed post-dilation on the study eye only, and the data was forwarded to the central reading center. The data was collected up to Week 48 instead of Week 96, due to early termination of the study. A positive change from baseline indicates an increase in the number of absolute scotomatous points (more lack of retinal sensitivity); disease worsening.|Baseline, Week 48|The microperimetry analysis population consisted of all participants who met the microperimetry eligibility criteria assessed by the reading center (participants at selected sites only; participants grouped according to treatment assigned at randomization). Participants analyzed in this outcome measure were those included in MMRM analysis.|||absolute scotomatous points||Standard Error|Mean
2593306|NCT02247479|Primary|Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluoresence (FAF) at Week 48|The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).|Baseline, Week 48|ITT population included all the participants who were randomized to the study. Participants analyzed in this outcome measure were those included in Mixed-effect model repeated measures (MMRM) analysis.|||millimeter square (mm^2)||Standard Error|Mean
2593307|NCT02247466|Secondary|Recurrences of Hernias|Number of recurrences of hernias by 2 year follow-up (separate publication).|2 years|||||||
2593308|NCT02247466|Secondary|Continuous Abdominal Contractions|"Number of patients experiencing episodes with continuous abdominal contractions where the abdomen feels tight but the operation can still proceed (the intestines are gradually displaced near the inner surface of the abdominal wall)"|3 hours||||Participants|||Count of Participants
2593309|NCT02247466|Secondary|Insufflator Alarms|Insufflator alarms where pneumoperitoneum > 17 mmHg Number of patients experiencing insufflator alarms where pneumoperitoneum > 17 mmHg|3 hours||||Participants|||Count of Participants
2593310|NCT02247466|Secondary|Contractions|Sudden contractions of the abdominal wall during operation (bucking or coughing), number of participants with sudden contractions|3 hours||||Participants|||Count of Participants
2593311|NCT02247466|Secondary|Suturing Time|Duration of suturing the hernia (minutes)|3 hours||||minutes||Full Range|Mean
2593312|NCT02247466|Secondary|Operating Time|Duration of operating time (from first incision to last suture)|3 hours||||minutes||Full Range|Mean
2593313|NCT02247466|Secondary|Surgical Conditions While Suturing|"Surgeon´s rating of surgical conditions while suturing the hernia (5-point rating scale)~(1 Extremely poor conditions; 2 Poor conditions; 3 Acceptable conditions; 4 Good conditions; 5 Optimal conditions)"|3 hours||||Participants|||Count of Participants
2593314|NCT02247466|Primary|Improvement of Surgical Workspace|"Improvement of surgical workspace (rated on a 5-point scale) estimated as the difference between the workspace during deep NMB and the workspace without NMB. Ratings are performed in the same patient during stable pneumoperitoneum at 12 mmHg.~(1 Extremely poor conditions; 2 Poor conditions; 3 Acceptable conditions; 4 Good conditions; 5 Optimal conditions)"|3 hours||||Participants|||Count of Participants
2593315|NCT02247440|Other Pre-specified|Number of Participants With Ribavirin Compliance at ≥ 95%, 80% - 95%, and < 80%|Number of participants with ribavirin compliance at ≥ 95%, 80% - 95%, and < 80%.|From initiation of treatment to the first 48 weeks of treatment|"subject discontinued treatment after week 1~subjects discontinued treatment after week 12~1 subject discontinued treatment after week 24"|||Participants|||Count of Participants
2593316|NCT02247440|Other Pre-specified|Number of Participants Able to Perform Self-injections of Peg-interferon|Number of participants able to perform self-injections of peg-interferon.|From initiation of treatment to the first 48 weeks of treatment|"subject discontinued treatment after week 1~subjects discontinued treatment after week 12~1 subject discontinued treatment after week 24"|||Participants|||Count of Participants
2593317|NCT02247440|Other Pre-specified|Number of Adverse Events by Severity Grade|Number of adverse events (AE) by severity grade. The severity grading scale is based on the DAIDS grading table, the grading scale ranging from grades 1 to 5: Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicates a potentially life-threatening event, and Grade 5 indicates death.|From initiation of treatment to 6 months after treatment discontinuation||||events|||Number
2593318|NCT02247440|Other Pre-specified|Number of Participants Completed the First 24 and 48 Weeks of Treatment|Number of participants completed the first 24 and 48 weeks of treatment.|From initiation of treatment to the first 48 weeks of treatment||||Participants|||Count of Participants
2593319|NCT02247440|Secondary|Number of Participants Grouped by HIV-1 RNA Concentrations|Number of participants grouped by HIV-1 RNA concentrations (Detected vs. Not Detected).|At time of treatment discontinuation (whatever its date) and 6 months thereafter||||Participants|||Count of Participants
2593320|NCT02247440|Secondary|Number of Participants With at Least a Serious Adverse Events Associated With Study Treatment (Peg-interferon and Ribavirin)|Number of participants with at least a serious adverse events associated with study treatment (peg-interferon and ribavirin).|From initiation of treatment to 6 months after treatment discontinuation||||Participants|||Count of Participants
2593321|NCT02247440|Primary|Number of Participants With Sustained Virological Response 6 Months After Treatment Discontinuation|Number of Participants with Sustained Virological Response 6 Months After Treatment Discontinuation,|6 months after end of treatment, i.e. 1.5 years after treatment initiation||||Participants|||Count of Participants
2593322|NCT02247401|Secondary|Percentage of Participants With Post-treatment Relapse Within 12 Weeks Following End of Treatment in Each Arm|Post-treatment relapse was defined as defined as confirmed HCV RNA > LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.|Up to 12 weeks after first dose|Intent-to-treat population: all participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2594359|NCT02233738|Secondary|Social Support Survey Total Score at 3 Months|Min value:19 Max value:95 Higher score indicates higher support|60 days prior to 3-month follow-up||||score on a scale||Standard Deviation|Mean
2593325|NCT02247401|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm|SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug.|12 weeks after last dose|Intent-to-treat population: all participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2593326|NCT02247245|Primary|Maximal Oxygen Consumption (Peak VO2)|"Cardiopulmonary exercise testing performance - measuring peak oxygen uptake during a treadmill CPEX test.~Subjects were exercised using the Bruce protocol, modified by the addition of a stage 0 at onset consisting of 3 min of exercise at 1.61 km·h−1 (1 mile·h−1) with a 5% gradient. Expired air was collected and metabolic gas exchange analysis performed in order to measure the maximal oxygen consumption (peak VO2) (Sensormedics, Yorba Linda, California).~The CPX equipment was recalibrated before every exercise test. All test subjects were encouraged to exercise to exhaustion before starting the test, and no further motivation or instructions were given."|Each test lasts up to 20 minutes||||ml/kg/min||Standard Error|Mean
2593327|NCT02247063|Secondary|Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline|Self-reported VAS from 0 (no pain) to 10 (worst possible pain)|One month after tDCS sessions compared to baseline (6 weeks)||||participants|||Number
2593328|NCT02247063|Primary|Number of Participants With Pain Relief as Measured by Visual Analog Scale (VAS) Decrease of 50% or Greater From Baseline|Self-reported VAS from 0 (no pain) to 10 (worst possible pain)|Post tDCS sessions compared to baseline (one week)||||participants|||Number
2593329|NCT02247011|Primary|Serum Creatinine|Fasting blood sample was collected for each subject.The level of serum creatinine(Cr) was analyzed.|5 years||||umol/l||Standard Error|Mean
2593330|NCT02247011|Primary|Serum Alkaline Phosphatase|Fasting blood sample was collected for each subject. The level of serum alkaline phosphatase (ALP) was analyzed.|5 years||||U/L||Standard Deviation|Mean
2593331|NCT02247011|Primary|Biochemical Markers|Fasting blood sample was collected for each subject. Common biochemical markers including serum calcium(Ca), serum phosphate(P), serum glucose(Glu), serum creatinine(Cr), alkaline phosphatase(ALP)were analyzed.|5 year||||mmol/L||Standard Deviation|Mean
2593332|NCT02247011|Primary|Bone Turnover Markers and 25(OH)D|C-terminal telopeptide of type I collagen (β-CTX), N-aminoterminal prepeptide of type I procollagen (P1NP), and 25-hydroxyvitamin D (25[OH]D) will be determined by a laboratory method of electrochemiluminescence (E170; Roche Diagnostics, Basel, Switzerland) in the institute (Peking Union)|5 year||||ng/ml||Inter-Quartile Range|Median
2593333|NCT02247011|Primary|Bone Mineral Density|bone mineral density of Lumbar spine and femoral neck were measured by dual-energy X-ray absorptiometry (DXA) (Lunar or Norland)|5 year||||g/cm^2||Inter-Quartile Range|Median
2593334|NCT02247011|Primary|Vertebral Fracture Incidence|Vertebral fractures were assessed by lateral radiograph. The overall incidence of vertebral fracture of the subjects is 5.23%( 51/975)|5 year||||participants|||Number
2593335|NCT02247011|Primary|Non-vertebral Fracture Incidence|Non-vertebral fractures were assessed by questionnaire survey.The overall incidence of non-vertebral fracture of the subjects is 7.18%( 70/975).|5 year|In 1100 participants, 975 of them finished the questionnaire|||participants|||Number
2593336|NCT02246998|Secondary|Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory Abnormalities|Graded laboratory abnormalities were defined as values that increased at least one toxicity grade from predose at any postdose up to the last dose date of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant.|Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days)|Safety Analysis Set|||Percentage of participants|||Number
2593337|NCT02246998|Secondary|Percentage of Participants Experiencing Adverse Events (AEs)|Incidences of adverse events and laboratory abnormalities will be summarized.|Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days)|Safety Analysis Set|||Percentage of participants|||Number
2593338|NCT02246998|Secondary|Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 24||Baseline; Week 24|Full Analysis Set|||cells/uL||Standard Deviation|Mean
2593339|NCT02246998|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL Week 24 as Determined by Snapshot Algorithm||Week 24|Full Analysis Set (FAS): all participants who (1) are randomized into the study and (2) have received at least one dose of study drug.|||percentage of participants|||Number
2593340|NCT02246998|Secondary|PK Parameter: AUCinf for Iohexol|AUC inf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).|"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero on Day 1 and Weeks 4, 8, 16, and 24"|Participants in the iohexol PK Analysis Set (all treated participants who have respective, evaluable PK profiles of iohexol) with available data were analyzed.|||h*µg/mL||Standard Deviation|Mean
2593341|NCT02246998|Secondary|PK Parameter: t1/2 for TFV||"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the TFV PK Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
2593342|NCT02246998|Secondary|PK Parameter: AUCtau for TFV||"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the TFV PK Analysis Set with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
2593343|NCT02246998|Secondary|PK Parameter: λz for TFV||"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the TFV PK Analysis Set with available data were analyzed.|||1/hour||Standard Deviation|Mean
2593344|NCT02246998|Secondary|PK Parameter: Ctau for TFV||"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the TFV PK Analysis Set with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2593345|NCT02246998|Secondary|PK Parameter: Tlast for TFV|Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.|"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the TFV PK Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
2593346|NCT02246998|Secondary|PK Parameter: Clast for TFV||"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the TFV PK Analysis Set with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2593353|NCT02246998|Secondary|PK Parameter: Tlast for RTV|Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.|"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the RTV PK Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
2593354|NCT02246998|Secondary|PK Parameter: Clast for RTV||"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the RTV PK Analysis Set with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2593355|NCT02246998|Secondary|PK Parameter: Tmax for RTV||"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the RTV PK Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
2593356|NCT02246998|Secondary|PK Parameter: Cmax for RTV||"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the RTV PK Analysis Set (all treated participants who have respective, evaluable PK profiles of RTV) with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2593357|NCT02246998|Secondary|PK Parameter: t1/2 for COBI|t1/2 is defined as the estimate of the terminal elimination half-life of the drug.|"Predose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the COBI PK Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
2593358|NCT02246998|Secondary|PK Parameter: AUCtau for COBI|AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).|"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the COBI PK Analysis Set with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
2593359|NCT02246998|Secondary|PK Parameter: λz for COBI|λz is defined as the terminal elimination rate constant.|"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the COBI PK Analysis Set with available data were analyzed.|||1/hour||Standard Deviation|Mean
2593360|NCT02246998|Secondary|PK Parameter: Ctau for COBI|Ctau is defined as the observed drug concentration at the end of the dosing interval.|"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the COBI PK Analysis Set with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2593361|NCT02246998|Secondary|PK Parameter: Tlast for COBI|"Tlast is defined as the time of Clast.~Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation."|"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the COBI PK Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
2593362|NCT02246998|Secondary|PK Parameter: Clast for COBI|Clast is defined as the last observable concentration of drug.|"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the COBI PK Analysis Set with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2593363|NCT02246998|Secondary|PK Parameter: Tmax for COBI|Tmax is defined as the time of Cmax.|"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the COBI PK Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
2593364|NCT02246998|Secondary|Pharmacokinetic (PK) Parameter: Cmax for COBI|Cmax is defined as the maximum observed concentration of drug in plasma.|"Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post time zero at Weeks 4, 8, 16, and 24"|Participants in the COBI PK Analysis Set (all treated participants who have respective, evaluable PK profiles of COBI) with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2593365|NCT02246998|Secondary|Percentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (µg/g) at Week 24||Baseline; Week 24|Participants in the PD Analysis Set with available data were analyzed.|||percentage change||Inter-Quartile Range|Median
2593366|NCT02246998|Secondary|Percentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (µg/g) at Week 24||Baseline; Week 24|Participants in the PD Analysis Set with available data were analyzed.|||percentage change||Inter-Quartile Range|Median
2593367|NCT02246998|Secondary|Percentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 24||Baseline; Week 24|Participants in the PD Analysis Set with available data were analyzed.|||percentage change||Inter-Quartile Range|Median
2593368|NCT02246998|Secondary|Percentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 24||Baseline; Week 24|Participants in the PD Analysis Set with available data were analyzed.|||percentage change||Inter-Quartile Range|Median
2593369|NCT02246998|Secondary|Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)||Up to 24 weeks plus 30 days|Participants in the Safety Analysis Set with available data were analyzed.|||percentage of participants|||Number
2593370|NCT02246998|Secondary|Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)||Up to 24 weeks plus 30 days|Safety Analysis Set|||Participants|||Count of Participants
2593371|NCT02246998|Primary|Estimated GFR Calculated by Modification of Diet in Renal Disease (MDRD) Formula at Week 24|MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. eGFR (mL/min/1.73 m^2) = 186 * (Scr)^-1.154 * (Age)^(-0.203) * (0.742 if female) * (1.212 if black). Scr = serum creatinine in mg/dL|Week 24|Participants in the PD Analysis Set with available data were analyzed.|||mL/min/1.73m^2||Standard Deviation|Mean
2593372|NCT02246998|Primary|Estimated GFR (eGFR) Calculated by Cockcroft-Gault Formula at Week 24|GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL|Week 24|Participants in the PD Analysis Set with available data were analyzed.|||mL/min||Standard Deviation|Mean
2593373|NCT02246998|Primary|Actual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24||Week 24|Participants in the pharmacodynamics (PD) analysis Set (all treated participants in each group, who have evaluable baseline and at least 1 postbaseline aGFR and /or eGFR at any visit) with available data were analyzed.|||mL/min||Standard Deviation|Mean
2593374|NCT02246777|Primary|Percentage of Eyes Receiving Secondary Surgical Treatment (Including Laser Therapy) Necessary to Maintain the IOP|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Secondary surgical treatment included needling, laser suture lysis, and conjunctival and scleral flap sutures. For some subjects, both left and right eyes were targeted for the study, and data from both eyes were analyzed for this safety endpoint, as specified in the protocol. An eye may have received more than one procedure.|Month 3, Month 6, Month 12 Post-Operative|Intent-to-Treat, with non-missing data|||percentage of eyes|Eyes||Number
2593375|NCT02246777|Primary|Percentage of Eyes Receiving Drug Therapy for Glaucoma Necessary to Maintain the IOP|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). For some subjects, both left and right eyes were targeted for the study, and data from both eyes were analyzed for this safety endpoint, as specified in the protocol.|Month 3, Month 6, Month 12 Post-Operative|Intent-to-Treat Analysis Set with non-missing data|||percentage of eyes|Eyes||Number
2593376|NCT02246777|Primary|Percentage of Eyes With IOP Lowering Rate of 20% or More From Baseline up to Month 12|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.|Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative|Intent-to-Treat, with non-missing data|||percentage of eyes|Eyes||Number
2593377|NCT02246777|Primary|Percent Change From Baseline in IOP|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis.|Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative|Intent-to-Treat, with non-missing data|||percent change|Eyes|Standard Deviation|Mean
2593378|NCT02246777|Primary|Change From Baseline in IOP|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. Only one eye contributed to the analysis.|Baseline (Pre-Operative), Month 3, Month 6, Month 12 Post-Operative|Intent-to-Treat, with non-missing data|||mmHG|Eyes|Standard Deviation|Mean
2593379|NCT02246777|Primary|Mean Intraocular Pressure (IOP)|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye contributed to the analysis.|Month 3, Month 6, Month 12 Post-Operative|Intent-to-Treat, with non-missing data|||mmHG|Eyes|Standard Deviation|Mean
2593380|NCT02246764|Primary|Extent of Exposure|Exposure to study medication in days for all treatment groups|12 months|Safety Population|||days||Standard Deviation|Mean
2593381|NCT02246673|Secondary|Incidence of Treatment-Emergent Adverse Events||10 weeks||||Number of participants|||Number
2593382|NCT02246673|Secondary|Apparent Terminal Half-life (t1/2)|t1/2 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma|Days 7 to 28||||hr||95% Confidence Interval|Geometric Mean
2593383|NCT02246673|Secondary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)|AUC last of multiple-dose RDEA3170 administered in combination with febuxostat from plasma|Days 7 to 28||||ng·hr/mL||95% Confidence Interval|Geometric Mean
2593384|NCT02246673|Secondary|Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)|AUC 0-24 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma|Days 7 to 28||||ng·hr/mL||95% Confidence Interval|Geometric Mean
2593385|NCT02246673|Secondary|Time of Occurrence of Maximum Observed Concentration (Tmax)|Tmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma|Days 7 to 28||||hr||Full Range|Median
2593386|NCT02246673|Secondary|Maximum Observed Plasma Concentration (Cmax)|Cmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma|Days 7 to 28||||ng/mL||95% Confidence Interval|Geometric Mean
2593387|NCT02246673|Primary|Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)|Percentage (%) change from baseline in fractional excretion of uric acid.|28 days||||Percentage (%)||Standard Error|Mean
2593388|NCT02246673|Primary|Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)|Percentage (%) change from baseline in renal clearance of uric acid.|28 days||||Percentage (%)||Standard Error|Mean
2593389|NCT02246673|Primary|Urine Uric Acid % Change (0-24h) (Aeur, CB)|Percentage (%) change from baseline in the amount of uric acid recovered in urine.|28 days||||Percentage (%)||Standard Error|Mean
2593390|NCT02246673|Primary|Serum Urate Maximum Percentage (%) Change (Emax, CB)|Maximum observed percentage (%) change from baseline in serum urate concentrations.|28 days||||Percentage (%)||Standard Error|Mean
2593391|NCT02246660|Primary|6-Minute Walk Distance, Meters|Six month changes in 6-Minute Walk Distance (meters) in response to resveratrol therapy in patients with Peripheral Artery Disease were measured.|Baseline and 6 month follow-up||||meters||Standard Deviation|Mean
2593392|NCT02246647|Secondary|Mean Serum Endotoxin (Bacterial LPS) Levels||Fasting, one time measurement after 8 hours|2 participants (1 in healthy volunteers and 1 in IBS-C) were not analysed for Mean Serum Endotoxin (Bacterial LPS) Levels due to various reasons such as non-availability of the blood sample, technical errors, etc.|||EU/mL||Standard Error|Mean
2593393|NCT02246647|Secondary|Duodenal Impedance||Baseline|12 participants (2 in Healthy volunteers and 10 in IBS-C) were not analysed for Duodenal impedance due to various reasons such inadequate size of the biopsy specimen, participant did not show up for the procedure, etc.|||Ω||Standard Error|Mean
2593394|NCT02246647|Secondary|Rate of E.Coli Bio- Particle K12 Flux Across Colonic Mucosa||Over 3 hours post E.coli Bio- Particle administration|7 participants (2 in Healthy volunteers and 5 in IBS-C) were not analysed for Rate of E.Coli Bio- Particle K12 Flux Across Colonic Mucosa due to various reasons such inadequate size of the biopsy specimen, participant did not show up for the procedure, etc.|||CFU/h/sq.cm||Standard Error|Mean
2593395|NCT02246647|Secondary|Cumulative E.Coli Bio- Particle K12 Concentration Across Colonic Mucosa||3 hours post E.coli Bio- Particle administration|7 participants (2 in Healthy volunteers and 5 in IBS-C) were not analysed for Cumulative E.coli Bio- Particle K12 Concentration Across Colonic Mucosa due to various reasons such inadequate size of the biopsy specimen, participant did not show up for the procedure, etc.|||CFU/ml||Standard Error|Mean
2593396|NCT02246647|Secondary|Rate of E.Coli Bio- Particle K12 Flux Across Duodenal Mucosa||Over 3 hours post E.coli Bio- Particle administration|11 participants (4 in Healthy volunteers and 7 in IBS-C) were not analysed for Rate of E.Coli Bio- Particle K12 Flux Across Duodenal Mucosa due to various reasons such inadequate size of the biopsy specimen, participant did not show up for the procedure, etc.|||CFU/h/sq.cm||Standard Error|Mean
2593397|NCT02246647|Secondary|Cumulative E.Coli Bio- Particle K12 Concentration Across Duodenal Mucosa||3 hours post E.coli Bio- Particle administration|11 participants (4 in Healthy volunteers and 7 in IBS-C) were not analysed for Cumulative E.Coli Bio- Particle K12 Concentration Across Duodenal Mucosa due to various reasons such inadequate size of the biopsy specimen, participant did not show up for the procedure, etc.|||CFU/ml||Standard Error|Mean
2593398|NCT02246647|Secondary|Rate of FITC-Dextran (4kDa) Flux Across Colonic Mucosa||Over 3 hours post FITC-Dextran (4kDa) administration|7 participants (2 in Healthy volunteers and 5 in IBS-C) were not analysed for the Rate of FITC-Dextran (4kDa) Flux Across Colonic Mucosa due to various reasons such inadequate size of the biopsy specimen, participant did not show up for the procedure, etc.|||ng/hr/sq.cm||Standard Error|Mean
2593399|NCT02246647|Secondary|Cumulative FITC-Dextran (4kDa) Concentration Across Colonic Mucosa||3 hours post FITC-Dextran (4kDa) administration|7 participants (2 in Healthy volunteers and 5 in IBS-C) were not analysed for the Cumulative FITC-Dextran (4kDa) Concentration Across Colonic Mucosa due to various reasons such inadequate size of the biopsy specimen, participant did not show up for the procedure, etc.|||ng/mL||Standard Error|Mean
2593400|NCT02246647|Secondary|Baseline Transmucosal Resistance (TMR) of Colonic Mucosa||Baseline|One participant in IBS-C was not analysed for the Baseline Transmucosal Resistance (TMR) of Colonic Mucosa due to various reasons such inadequate size of the biopsy specimen.|||Ω*sq.cm||Standard Error|Mean
2593401|NCT02246647|Secondary|Rate of FITC-Dextran (4kDa) Flux Across Duodenal Mucosa|This is not a pharmacokinetic or pharmacodynamic measure. Hence only one time assessment is made 3 hours after FITC-Dextran (4kDa) administration.|Over 3 hours post FITC-Dextran (4kDa) administration|Four participants ( 2 in Healthy volunteers and 2 in IBS-C ) were not analysed for the Rate of FITC-Dextran (4kDa) flux across duodenal mucosa due to various reasons such inadequate size of the biopsy specimen, participant did not show up for the procedure etc.|||ng/hr/sq.cm||Standard Error|Mean
2593402|NCT02246647|Secondary|Cumulative FITC-Dextran (4kDa) Concentration Across Duodenal Mucosa|This is not a pharmacokinetic or pharmacodynamic measure. Hence only one time assessment is made 3 hours after FITC-Dextran (4kDa) administration.|3 hours post FITC-Dextran (4kDa) administration|Four participants (2 in Healthy volunteers and 2 in IBS-C) were not analysed for the Cumulative FITC-Dextran (4kDa) concentration across duodenal mucosa due to various reasons such inadequate size of the biopsy specimen, participant did not show up for the procedure, etc.|||ng/mL||Standard Error|Mean
2593403|NCT02246647|Secondary|Baseline Transmucosal Resistance (TMR) of Duodenal Mucosa||Baseline|Two participants ( 1 in Healthy volunteers and 1 in IBS-C ) were not analysed for the Baseline transmucosal resistance (TMR) of duodenal mucosa due to various reasons such inadequate size of the biopsy specimen, participant did not show up for the procedure etc.|||Ω*sq.cm||Standard Error|Mean
2593404|NCT02246647|Secondary|Lactose:C13 Mannitol Excretion Ratio 0-2hours||0-2 hr post-test dose administration||||Ratio||Standard Error|Mean
2593405|NCT02246647|Primary|Lactulose:C13 Mannitol Excretion Ratio 8-24hrs.|In vivo measurement of intestinal permeability using 13C mannitol & lactulose was used. High performance liquid chromatography-tandem mass spectrometry was used to measure concentrations calculated using the overall urine volume excreted in each interval. Concentrations of 13C adjusted for the % of 13C in 12C mannitol (4.98% of 12C mannitol excreted was subtracted from 13C mannitol values; determined by analyzing replicate samples of control urine). All lactulose or 13C mannitol concentrations 8-24hr post-ingestion were used to determine colonic permeability. Lactulose to 13C mannitol excretion ratios, as a measure of dose of saccharide administered, were calculated.|8-24 hr post test-dose administration||||Ratio||Standard Error|Mean
2593406|NCT02246621|Secondary|PK: Hepatic Clearance of Abemaciclib, and Apparent Hepatic Clearance of Its Metabolites M2 and M20||Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose|All randomized participants who received at least one dose of study drug with evaluable PK data.|||liters/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2593407|NCT02246621|Secondary|Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Abemaciclib and Its Metabolites M2 and M20||Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose|All randomized participants who received at least one dose of study drug with evaluable PK data.|||nanogram*hours/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2593408|NCT02246621|Secondary|Change From Baseline to End of Study in Health Status on the EuroQol-5D 5L Visual Analog Scale (VAS) Scores Scale|"The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).~Minimally important differences in the EQ-5D VAS score are 7 or greater in cancer patients, per Pickard et al (2007)."|Baseline, End of Study (Estimated up to 34 Months)|Zero participants analyzed. Efficacy data were analyzed based upon the interim analysis as described in the study design. This outcome measure is from baseline to end of study and will be analyzed and reported after the end of study data are collected. Anticipated reporting December 2018.||||||
2593438|NCT02246439|Secondary|Responders Through 4 Days After First Dose of Study Medication - ITT Population|Treatment success, as defined in the primary outcome, through 4 days following first dose of study medication.|4 Days|The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.|||Participants|||Count of Participants
2593409|NCT02246621|Secondary|Change From Baseline to End of Study in Health Status on the EuroQuol 5-Dimension 5 Level (EuroQol-5D 5L)|"The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts.The first part consists of 5 descriptors of current health state (mobility, self care, usual activities, pain/discomfort, and anxiety/ depression); a participant is asked to rate each state on a five level scale (no problem, slight problem, moderate problem, severe problem and extreme problem) with higher levels indicating greater severity/ impairment. Published weights are available that allow for the creation of a single summary score called the EQ-5D index that ranges from 0 to 1, with low scores representing a higher level of dysfunction and 1 as perfect health.~Minimally important differences in the EQ-5D index score are 0.06 or greater in cancer patients, per Pickard et al (2007)."|Baseline, End of Study (Estimated up to 34 Months)|Zero participants analyzed. Efficacy data were analyzed based upon the interim analysis as described in the study design. This outcome measure is from baseline to end of study and will be analyzed and reported after the end of study data are collected. Anticipated reporting December 2018.||||||
2593410|NCT02246621|Secondary|Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire|"The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from: 1, Not at all; 2, A little; 3, Quite a bit; to 4, Very much . All scores are converted to a 0 to 100 scale. For functional scales, higher scores represent a better level of functioning."|Baseline, End of Study (Estimated up to 34 Months)|Zero participants analyzed. Efficacy data were analyzed based upon the interim analysis as described in the study design. This outcome measure is from baseline to end of study and will be analyzed and reported after the end of study data are collected. Anticipated reporting December 2018.||||||
2593411|NCT02246621|Secondary|Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores|"EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. Symptom scale ranges from: 1, Not at all; 2, A little; 3, Quite a bit; to 4, Very much. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.~EORTC change score definitions are described in Cocks et al, (2012) and differ according to each item. Small changes are generally defined as at least a 3, 4 or 5 point change from baseline"|Baseline, End of Study (Estimated up to 34 Months)|Zero participants analyzed. Efficacy data were analyzed based upon the interim analysis as described in the study design. This outcome measure is from baseline to end of study and will be analyzed and reported after the end of study data are collected. Anticipated reporting December 2018.||||||
2593412|NCT02246621|Secondary|Change From Baseline to End of Study in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Functional Scale Scores|"EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. Functional scale options are defined on a 7-point scale ranging from 1, Very poor to 7, Excellent. A linear transformation is applied to standardize the raw scores to range between 0 and 100. For functional domains and global health status, higher scores represent a better level of functioning. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate. EORTC change score definitions are described in Cocks et al, (2012) and differ for each item. Small changes are generally defined as at least a 3, 4 or 5 point change from baseline."|Baseline, End of Study (Estimated up to 34 Months)|Zero participants analyzed. Efficacy data were analyzed based upon the interim analysis as described in the study design. This outcome measure is from baseline to end of study and will be analyzed and reported after the end of study data are collected. Anticipated reporting December 2018.||||||
2593413|NCT02246621|Secondary|Percentage of Participants With Tumor Response of SD for at Least 6 Months, PR, or CR (Clinical Benefit Rate [CBR])|CBR defined as percentage of participants with best overall response of CR, PR, or SD with a duration of at least 6 months. CR, PR, or SD were defined using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months / number of participants enrolled) * 100.|Randomization to Progressive Disease or Death Due to Any Cause (Up to 26 Months)|All randomized participants.|||Percentage of Participants||95% Confidence Interval|Number
2593414|NCT02246621|Secondary|Percentage of Participants With CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])|DCR was the percentage of participants with a best overall response of CR, PR, or SD as per response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.|Randomization to Progressive Disease or Death Due to Any Cause (Up to 26 Months)|All randomized participants.|||Percentage of Participants||95% Confidence Interval|Number
2593558|NCT02244918|Secondary|Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol)|Measured by a change in NNAL (4-(methyl nitrosamine)-1-(3-pyridyl)-1-butanol),a biochemical marker of tobacco-specific carcinogen exposure. Levels assessed by urine sample from each participant and Weeks 0 and 12.|Weeks 0, 12|The number of participants analyzed at follow-up time-points reflects only those who returned at that point.|||pg/ml||Standard Deviation|Mean
2593415|NCT02246621|Secondary|Duration of Response (DoR)|DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.|CR or PR to Disease Progression or Death Due to Any Cause (Up to 26 Months)|All randomized participants who received at least one dose of study drug and first evidence of CR or PR as assessed by the investigator.|||Months||95% Confidence Interval|Median
2593416|NCT02246621|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])|ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.|Randomization to Progressive Disease or Death Due to Any Cause (Up to 26 Months)|All randomized participants.|||Percentage of Participants||95% Confidence Interval|Number
2593417|NCT02246621|Secondary|Overall Survival (OS)|OS defined as the time from first dose date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.|Randomization to Progressive Disease or Death Due to Any Cause (Estimated Up to 82 Months)||2021-12-31|12/2021||||
2593418|NCT02246621|Primary|Progression Free Survival (PFS)|PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.|Randomization to Progressive Disease or Death Due to Any Cause (Up to 26 Months)|All randomized participants.|||Months||95% Confidence Interval|Median
2593419|NCT02246608|Secondary|Growth Factors|Fluid collected from the wound will be examined for the presence of growth factors and interleukins.|12 weeks|Data ended up not being collected for subjects and analysis was not completed for this outcome. Only have data on wound healing from wound measurements.||||||
2593420|NCT02246608|Primary|Closure Rate of Non-healing Wounds|Wound dimensions will be measured weekly and monitored for changes|12 weeks||||percentage of healing||Standard Deviation|Mean
2593421|NCT02246582|Secondary|Retrospective Analysis (MARD for the GSR With Minimum and 1 Additional Calibration)|Retrospective analysis using one GSR: minimum and 3-4 calibrations will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values during YSI frequent sample testing. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.|7 Days|Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.|||percentage||Standard Deviation|Mean
2593422|NCT02246582|Secondary|Retrospective Re-Analysis (MARD With 1 Additional Calibration)|Retrospective re-analysis to simulate 640G Pump and Guardian Mobile 1-minute raw data collected by GST3C Transmitters and GST4C Transmitter: Enlite 3 Sensor accuracy with 3-4 calibrations throughout the day (derived from re-analysis of Enlite 3 Sensor data using actual fingerstick values). Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.|7 Days|Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.|||percentage||Standard Deviation|Mean
2593423|NCT02246582|Primary|Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD)|Enlite 3 Sensor accuracy using two real time devices: 1) 640G Pump and 2) Guardian Mobile with the minimum calibration requirements (every 12 hours after the second calibration) will be evaluated. Enlite 3 Sensor values will be compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing days (Days 1, 3 and 7). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Note that results from multiple testing days will be pooled together for reporting purpose.|7 Days|Even though participants were randomized to two groups, data was collected as a whole and there was no intention to analyze the two groups seperately.|||percentage||Standard Deviation|Mean
2593424|NCT02246439|Post-Hoc|Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - PP Population (Logistic Regression Adjusted by Baseline Nausea Severity)|Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose (analyzed using logistic regression with treatment as a factor and baseline nausea severity as a continuous variable)|24 Hours|The Per Protocol Population contained all patients who met all inclusion/exclusion criteria, received a second dose of medication if they vomited within 15 minutes of receiving the first dose, and did not have a primary diagnosis upon discharge from the ED (or, if admitted, discharge from the hospital) other than acute gastroenteritis/gastritis.|||Participants|||Count of Participants
2594360|NCT02233738|Secondary|Social Support Survey Total Score at 1 Month|Min value:19 Max value:95 Higher score indicates higher support|30 days prior to 1-month follow-up||||score on a scale||Standard Deviation|Mean
2593425|NCT02246439|Post-Hoc|Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population (Logistic Regression Adjusted by Baseline Nausea Severity)|Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose (analyzed using logistic regression with treatment as a factor and baseline nausea severity as a continuous variable)|24 Hours|The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication. The primary efficacy analysis was conducted using the ITT Population.|||Participants|||Count of Participants
2593426|NCT02246439|Post-Hoc|Primary Endpoint Subgroup Analysis - PP Population|Examination of treatment success rates by age (<18 and ≥18 years).|24 Hours|The Per Protocol (PP) Population contained all patients who met all inclusion/exclusion criteria, received a second dose of medication if they vomited within 15 minutes of receiving first dose, and did not have a primary diagnosis upon discharge from the ED (or, if admitted, discharge from the hospital) other than acute gastroenteritis/gastritis.|||Participants|||Count of Participants
2593427|NCT02246439|Other Pre-specified|Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - PP Population|Proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose|24 Hours|The Per Protocol Population contained all patients who met all inclusion/exclusion criteria, received a second dose of study medication if they vomited within 15 minutes of receiving the first dose, & did not have a primary diagnosis upon discharge from ED (or, if admitted, discharge from the hospital) other than acute gastroenteritis/gastritis.|||Participants|||Count of Participants
2593428|NCT02246439|Other Pre-specified|Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication by Baseline Nausea Severity - ITT Population, All Ages|Proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose|24 Hours|The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.|||Participants|||Count of Participants
2593429|NCT02246439|Secondary|Number of Patients Returning to Emergency Department - ITT Population|Proportion of patients returning to emergency department for gastrointestinal symptoms within 4 days of initial discharge|Day 1 of Study - Day 5 of Study||||Participants|||Count of Participants
2593430|NCT02246439|Secondary|Number of Patients Requiring Hospitalization - ITT Population|Number of patients requiring hospitalization. 4 patients in the RHB-102 treatment group and 1 patient in the placebo treatment group were hospitalized due to lack of efficacy. The remaining patients hospitalized were admitted for reasons other than gastroenteritis.|Day 1 of Study - Day 5 of Study|The number of treated patients requiring hospitalization was low in this study (14 patients). In the RHB-102 group, 11 patients (5.7%) were hospitalized, including one who returned to the ED for gastrointestinal symptoms 2 days after initial treatment. In the placebo treatment group, 3 patients (2.3%) were hospitalized.|||Participants|||Count of Participants
2593431|NCT02246439|Secondary|Time to Resumption of Normal Activities (Work/School/Household) - ITT Population|Time from first dose of study medication to resumption of normal activities (work/school/household).|Hours from first dose of study medication to resumption of normal activities|The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.|||Hours||95% Confidence Interval|Median
2593432|NCT02246439|Secondary|Time to Discharge From Emergency Department (ED), Extended Observation Unit, or Hospital - ITT Population|Time from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last, and when clinically appropriate.|Hours from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last|Patients were required to stay in the ED for at least 2 hours (first 172 patients) and subsequently, when post-treatment ECGs were introduced, for 4 hours. Since not all patients had prolonged ED stays, a difference in time until patients were clinically eligible for discharge may have been masked.|||Hours||95% Confidence Interval|Median
2593433|NCT02246439|Secondary|Incidence and Severity of Diarrhea - ITT Population|"Severity of diarrhea for patients having bowel movements was assessed using the Bristol Stool Scale (BSS), a Likert scale rating bowel movements from 1=separate hard lumps, like nuts, to 7=watery, no solid pieces; entirely liquid. The BSS was added to the emergency room day and follow-up diaries beginning with protocol amendment 3."|From 30 Minutes Through 24 Hours after First Dose of Study Medication|The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.|||Participants|||Count of Participants
2593434|NCT02246439|Secondary|Severity of Nausea at Baseline - ITT Population|Severity of nausea was assessed using a 5-point Likert scale: 0=no nausea; 1=mild nausea; 2=moderate nausea; 3=severe nausea; 4=nausea as bad as can be.|Day 1 - Baseline through 5 Hours Post Dose|The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.|||score on a scale||Standard Deviation|Mean
2593435|NCT02246439|Secondary|Number of Patients Receiving Intravenous Fluids - ITT Population|Patients receiving parenteral hydration within 24 hours after the first dose of study medication.|24 Hours|The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.|||Participants|||Count of Participants
2593436|NCT02246439|Secondary|Number of Patients Receiving Rescue Antiemetic Therapy - ITT Population|Patients receiving rescue antiemetic therapy within 24 hours after the first dose of study medication.|24 Hours|The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.|||Participants|||Count of Participants
2593437|NCT02246439|Secondary|Number of Participants Who Vomited - ITT Population|Analysis of vomiting from 30 minutes after first administration of study medication until 24 hours post first dose|24 Hours|The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.|||Participants|||Count of Participants
2593439|NCT02246439|Primary|Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population|Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose|24 Hours|The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.|||Participants|||Count of Participants
2593440|NCT02246309|Other Pre-specified|Clinical Pregnancy Rate|Existence of Clinical Pregnancy documented by sonogram 4 weeks after embryo transfer|4 weeks||||Participants|||Count of Participants
2593441|NCT02246309|Secondary|Embryo Quality|Number of Grade A best quality of day 3 embryos (based on cell number and degree of fragmentation)|Three Days||||Embryos||Standard Error|Mean
2593442|NCT02246309|Primary|Personnel Effort|Number of minutes spent by laboratory personnel technical staff in support of each system|Three days||||technical staff minutes spent per embryo|embryos|Standard Error|Mean
2593443|NCT02246218|Secondary|Assessment of Urinary PAA Concentrations Up to End of Trial: Cohort of 0 Months to <2 Months Participants||Day 7, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 15, End of Trial (up to Month 15)|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593444|NCT02246218|Secondary|Assessment of Urinary PAA Concentrations on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants||Hour 0 and between 0.5 and 1.5 hours, 1.5 and 2.5 hours, 4 and 6 hours, 7.5 and 8.5 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593445|NCT02246218|Secondary|Assessment of Urinary PAGN Concentrations Up to End of Trial: Cohort of 0 Months to <2 Months Participants||Day 7, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, End of Trial (up to Month 15)|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593446|NCT02246218|Secondary|Assessment of Urinary PAGN Concentrations on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants||Hour 0 and between 0.5 and 1 hour, 1.5 and 2.5 hours, 4 and 6 hours, 7.5 and 8.5 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593447|NCT02246218|Secondary|Plasma PAGN Tmax on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||hours||Standard Deviation|Mean
2593448|NCT02246218|Secondary|Plasma PAGN AUC(0-last) on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg*hr/mL||Standard Deviation|Mean
2593449|NCT02246218|Secondary|Plasma PAGN Cmin on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593450|NCT02246218|Secondary|Plasma PAGN Cmax on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593451|NCT02246218|Secondary|Plasma PAA Tmax on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||hours||Standard Deviation|Mean
2593452|NCT02246218|Secondary|Plasma PAA AUC(0-last) on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg*hr/mL||Standard Deviation|Mean
2593453|NCT02246218|Secondary|Plasma PAA Cmin on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593454|NCT02246218|Secondary|Plasma PAA Cmax on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593455|NCT02246218|Secondary|Plasma PBA Tmax on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||hours||Standard Deviation|Mean
2593456|NCT02246218|Secondary|Plasma PBA AUC(0-last) on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg*hr/mL||Standard Deviation|Mean
2593457|NCT02246218|Secondary|Plasma PBA Cmin on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593458|NCT02246218|Secondary|Plasma PBA Cmax on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593459|NCT02246218|Secondary|Assessment of Growth and Development: Baseline and Change From Baseline in BSA Z-Score Up to Month 24: Cohort of 0 Months to <2 Months Participants|To assess any effect of study drug treatment on growth, Z-scores were calculated to express the deviation from a reference population for BSA. The Z-scores are based on weight-for-length charts. Negative Z-scores indicate lower than typical for age and gender while positive scores indicate higher than typical for age and gender.|Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24|Safety Population: all enrolled participants who received any amount of study medication and had an assessment.|||z-score||Standard Deviation|Mean
2593460|NCT02246218|Secondary|Assessment of Growth and Development: Baseline and Change From Baseline in BMI Z-Score Up to Month 24: Cohort of 0 Months to <2 Months Participants|To assess any effect of study drug treatment on growth, Z-scores were calculated to express the deviation from a reference population for BMI. The Z-scores are based on the World Health Organization's Child Growth Standards charts. Negative Z-scores indicate lower than typical for age and gender while positive scores indicate higher than typical for age and gender.|Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24|Safety Population: all enrolled participants who received any amount of study medication and had an assessment.|||z-score||Standard Deviation|Mean
2593461|NCT02246218|Secondary|Amino Acid Assessment: Baseline and Change From Baseline in Valine Up to Month 24: Cohort of 0 Months to <2 Months Participants||Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24|Safety Population: all enrolled participants who received any amount of study medication and had an assessment.|||μmol/L||Standard Deviation|Mean
2593462|NCT02246218|Secondary|Amino Acid Assessment: Baseline and Change From Baseline in Leucine Up to Month 24: Cohort of 0 Months to <2 Months Participants||Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24|Safety Population: all enrolled participants who received any amount of study medication and had an assessment.|||μmol/L||Standard Deviation|Mean
2593463|NCT02246218|Secondary|Amino Acid Assessment: Baseline and Change From Baseline in Isoleucine Up to Month 24: Cohort of 0 Months to <2 Months Participants||Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24|Safety Population: all enrolled participants who received any amount of study medication and had an assessment.|||μmol/L||Standard Deviation|Mean
2593464|NCT02246218|Secondary|Amino Acid Assessment: Baseline and Change From Baseline in Sum of Glutamine and Glutamate Up to Month 24: Cohort of 0 Months to <2 Months Participants||Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24|Safety Population: all enrolled participants who received any amount of study medication and had an assessment.|||μmol/L||Standard Deviation|Mean
2593465|NCT02246218|Secondary|Amino Acid Assessment: Baseline and Change From Baseline in Glutamine Up to Month 24: Cohort of 0 Months to <2 Months Participants||Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24|Safety Population: all enrolled participants who received any amount of study medication and had an assessment.|||μmol/L||Standard Deviation|Mean
2593466|NCT02246218|Secondary|Amino Acid Assessment: Baseline and Change From Baseline in Glutamate Up to Month 24: Cohort of 0 Months to <2 Months Participants||Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24|Safety Population: all enrolled participants who received any amount of study medication and had an assessment.|||μmol/L||Standard Deviation|Mean
2593467|NCT02246218|Secondary|Number of Participants With TEAEs, Serious TEAEs, Deaths, and Discontinuations Due to TEAEs: Cohort of 0 Months to <2 Months Participants|An AE is any untoward medical occurrence, whether or not the event is considered related to the study drug. A serious AE is any AE that: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. TEAEs are defined as AEs with an onset date on or after the first dose of study medication until study discontinuation. The Investigator assessed the causal relationship of each TEAE to the study drug as not related, possibly related, or probably related.|From the first dose of study treatment through 30 days after the final dose (mean [SD] duration of treatment was 10.67 [6.142] months).|Safety Population: all enrolled participants who received any amount of study medication.|||Participants|||Count of Participants
2593559|NCT02244918|Secondary|Concentration of Urinary Cotinine|Measured by urinary cotinine, a biochemical marker of nicotine intake, sampled from participants at weeks 0 and 26.|Weeks 0, 26|Number analyzed at the week 26 follow-up time point reflects the number of participants who returned for this visit.|||ng/ml||Standard Deviation|Mean
2593468|NCT02246218|Secondary|Rate of HACs: Cohort of 0 Months to <2 Months Participants|HAC is defined as having signs and symptoms consistent with hyperammonemia (such as but not limited to frequent vomiting, nausea, headache, lethargy, irritability, combativeness, and/or somnolence) associated with high blood ammonia and requiring medical intervention. Rate of HACs per 6 months during the safety extension was calculated as sum of (number of HAC) / sum of (days during first 6 months starting on Day 8 or number days on RAVICTI, whichever is less) across all participants in the corresponding group.|Day 8 through up to Month 6|Safety Population: all enrolled participants who received any amount of study medication.|||HACs per half-year of patient exposure|||Number
2593469|NCT02246218|Secondary|Assessment of Urinary PAA Concentrations Up to End of Trial: Cohort of 2 Months to <2 Years Participants||Day 7, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 15, Month 18, End of Trial (up to Month 18)|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593470|NCT02246218|Secondary|Assessment of Urinary PAA Concentrations on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants||Hour 0 and between 0.5 and 1.5 hours, 1.5 and 2.5 hours, 4 and 6 hours, 7.5 and 8.5 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593471|NCT02246218|Secondary|Assessment of Urinary PAGN Concentrations Up to End of Trial: Cohort of 2 Months to <2 Years Participants||Day 7, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, End of Trial (up to Month 18)|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593472|NCT02246218|Secondary|Assessment of Urinary PAGN Concentrations on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants||Hour 0 and between 0.5 and 1 hour, 1.5 and 2.5 hours, 4 and 6 hours, 7.5 and 8.5 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593473|NCT02246218|Secondary|Plasma PAGN Tmax on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||hours||Standard Deviation|Mean
2593474|NCT02246218|Secondary|Plasma PAGN AUC(0-last) on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg*hr/mL||Standard Deviation|Mean
2593475|NCT02246218|Secondary|Plasma PAGN Cmin on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593476|NCT02246218|Secondary|Plasma Phenylacetylglutamine (PAGN) Cmax on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593477|NCT02246218|Secondary|Plasma PAA Tmax on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||hours||Standard Deviation|Mean
2593478|NCT02246218|Secondary|Plasma PAA AUC(0-last) on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg*hr/mL||Standard Deviation|Mean
2593479|NCT02246218|Secondary|Plasma PAA Cmin on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593480|NCT02246218|Secondary|Plasma Phenylacetate/Phenylacetic Acid (PAA) Cmax on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593481|NCT02246218|Secondary|Plasma PBA Time to Cmax (Tmax) on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||hours||Standard Deviation|Mean
2593482|NCT02246218|Secondary|Plasma PBA Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-last]) on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg*hr/mL||Standard Deviation|Mean
2593483|NCT02246218|Secondary|Plasma PBA Minimum Plasma Concentration (Cmin) on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|PK Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593484|NCT02246218|Secondary|Plasma Phenylbutyrate/Phenylbutyric Acid (PBA) Maximum Plasma Concentration (Cmax) on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants||Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC|Pharmacokinetic (PK) Evaluable Population: all participants from the safety population with individual concentration-time profiles that allow computation of meaningful PK parameter values.|||μg/mL||Standard Deviation|Mean
2593485|NCT02246218|Secondary|Assessment of Growth and Development: Baseline and Change From Baseline in Body Surface Area (BSA) Z-Score Up to Month 24: Cohort of 2 Months to <2 Years Participants|To assess any effect of study drug treatment on growth, Z-scores were calculated to express the deviation from a reference population for BSA. The Z-scores are based on weight-for-length charts. Negative Z-scores indicate lower than typical for age and gender while positive scores indicate higher than typical for age and gender.|Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24|Safety Population: all enrolled participants who received any amount of study medication and had an assessment.|||z-score||Standard Deviation|Mean
2593486|NCT02246218|Secondary|Assessment of Growth and Development: Baseline and Change From Baseline in Body Mass Index (BMI) Z-Score Up to Month 24: Cohort of 2 Months to <2 Years Participants|To assess any effect of study drug treatment on growth, Z-scores were calculated to express the deviation from a reference population for BMI. The Z-scores are based on the World Health Organization's Child Growth Standards charts. Negative Z-scores indicate lower than typical for age and gender while positive scores indicate higher than typical for age and gender.|Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24|Safety Population: all enrolled participants who received any amount of study medication and had an assessment.|||z-score||Standard Deviation|Mean
2593487|NCT02246218|Secondary|Amino Acid Assessment: Baseline and Change From Baseline in Valine Up to Month 24: Cohort of 2 Months to <2 Years Participants||Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24|Safety Population: all enrolled participants who received any amount of study medication and had an assessment at given time point.|||µmol/L||Standard Deviation|Mean
2593488|NCT02246218|Secondary|Amino Acid Assessment: Baseline and Change From Baseline in Leucine Up to Month 24: Cohort of 2 Months to <2 Years Participants||Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24|Safety Population: all enrolled participants who received any amount of study medication and had an assessment at given time point.|||µmol/L||Standard Deviation|Mean
2593489|NCT02246218|Secondary|Amino Acid Assessment: Baseline and Change From Baseline in Isoleucine Up to Month 24: Cohort of 2 Months to <2 Years Participants||Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24|Safety Population: all enrolled participants who received any amount of study medication and had an assessment at given time point.|||µmol/L||Standard Deviation|Mean
2593490|NCT02246218|Secondary|Amino Acid Assessment: Baseline and Change From Baseline in Sum of Glutamine and Glutamate Up to Month 24: Cohort of 2 Months to <2 Years Participants||Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24|Safety Population: all enrolled participants who received any amount of study medication and had an assessment at given time point.|||µmol/L||Standard Deviation|Mean
2593491|NCT02246218|Secondary|Amino Acid Assessment: Baseline and Change From Baseline in Glutamine Up to Month 24: Cohort of 2 Months to <2 Years Participants||Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24|Safety Population: all enrolled participants who received any amount of study medication and had an assessment at given time point.|||µmol/L||Standard Deviation|Mean
2593492|NCT02246218|Secondary|Amino Acid Assessment: Baseline and Change From Baseline in Glutamate Up to Month 24: Cohort of 2 Months to <2 Years Participants||Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24|Safety Population: all enrolled participants who received any amount of study medication and had an assessment at given time point.|||µmol/L||Standard Deviation|Mean
2593493|NCT02246218|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Deaths, and Discontinuations Due to TEAEs: Cohort of 2 Months to <2 Years Participants|An adverse event (AE) is any untoward medical occurrence, whether or not the event is considered related to the study drug. A serious AE is any AE that: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. TEAEs are defined as AEs with an onset date on or after the first dose of study medication until study discontinuation. The Investigator assessed the causal relationship of each TEAE to the study drug as not related, possibly related, or probably related.|From the first dose of study treatment through 30 days after the final dose (mean [SD] duration of treatment was 9.13 [6.838] months).|Safety Population: all enrolled participants who received any amount of study medication.|||Participants|||Count of Participants
2593560|NCT02244918|Secondary|Smoking Abstinence|Biochemically confirmed 30-day point prevalence abstinence at Week 26 using urinary cotinine, with the recommended cut-off of 50 ng/ml to differentiate smokers from non-smokers.|Week 26||||Participants|||Count of Participants
2594361|NCT02233738|Secondary|Social Support Survey Total Score at Baseline|Min value:19 Max value:95 Higher score indicates higher support|30 days prior to Baseline||||score on a scale||Standard Deviation|Mean
2593494|NCT02246218|Secondary|Rate of Hyperammonemic Crises (HACs): Cohort of 2 Months to <2 Years Participants|HAC is defined having signs and symptoms consistent with hyperammonemia (such as but not limited to frequent vomiting, nausea, headache, lethargy, irritability, combativeness, and/or somnolence) associated with high blood ammonia and requiring medical intervention. Rate of HACs per 6 months during the safety extension is calculated as sum of (number of HAC) / sum of (days during first 6 months starting on Day 8 or number days on RAVICTI, whichever is less) across all participants in the corresponding group.|Day 8 through up to Month 6|Safety Population: all enrolled participants who received any amount of study medication and had an assessment.|||HACs per half-year of patient exposure|||Number
2593495|NCT02246218|Primary|Percentage of Participants With Successful Transition to RAVICTI With Controlled Ammonia (i.e. No Clinical Symptoms and Ammonia < 100 μmol/L): Cohort of 0 Months to <2 Months Participants|"The percentage of participants with successful transition is based on Investigator response to the question, Has transition to 100% RAVICTI been successful with controlled ammonia? For participants < 2 months of age, after a minimum of 24 hours of ammonia monitoring following the first full dose of RAVICTI alone, the participant was effectively transitioned when following conditions were met: no signs and symptoms of hyperammonemia; ammonia level less than 100 μmol/L (without normalization of ammonia, ie, without conversion of values from local laboratories with varying normal ranges to standardized values); and eligible for discharge per Investigator judgment."|Up to Day 4|Safety Population: all enrolled participants who received any amount of study medication.|||percentage of participants|||Number
2593496|NCT02246218|Primary|Percentage of Participants With Successful Transition to RAVICTI With Controlled Ammonia (i.e. No Clinical Symptoms and Ammonia < 100 μmol/L): Cohort of 2 Months to <2 Years Participants|"The percentage of participants with successful transition is based on Investigator response to the question, Has transition to 100% RAVICTI been successful with controlled ammonia? For participants 2 months of age and older, after a minimum of 24 hours of ammonia monitoring following the first full dose of RAVICTI alone, the participant was effectively transitioned when following conditions were met: no signs and symptoms of hyperammonemia; ammonia level less than 100 μmol/L (without normalization of ammonia, ie, without conversion of values from local laboratories with varying normal ranges to standardized values); and eligible for discharge per Investigator judgment."|Up to Day 4|Safety Population: all enrolled participants who received any amount of study medication.|||percentage of participants|||Number
2593497|NCT02246166|Secondary|Body Temperature Reduction|Summary statistics for body temperature was presented at baseline and at 15, 30, 60, 120,180 and 240 minutes post treatment. Wilcoxon Rank Sum test was used to investigate if there are any significant treatment differences.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||°C (degree Celsius)||Standard Error|Least Squares Mean
2593498|NCT02246166|Secondary|Cough Severity Assessment|Participants self-assessed cough severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All cough severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
2593499|NCT02246166|Secondary|Sneezing Severity Assessment|Participants self-assessed sneezing severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sneezing severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
2593500|NCT02246166|Secondary|Runny Nose Severity Assessment|Participants self-assessed runny nose severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All runny nose severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
2593501|NCT02246166|Secondary|Nasal Congestion Severity Assessment|Participants self-assessed nasal congestion severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All nasal congestion severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
2593552|NCT02244996|Primary|ETDRS Visual Acuity (High Contrast)|"The high contrast visual acuity will be measured at the time point of baseline and 12 months. Visual acuity is to measure the eye's ability to resolve fine detail with full refractive error correction.~The change of acuity (sec of arc) between 12-month time point and baseline will be provided to show the effect of interventions.~The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum."|12 months||||log unit||Standard Deviation|Mean
2605758|NCT02107014|Primary|Change in IL-6 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2593502|NCT02246166|Secondary|Extremities Pain Severity Assessment|Participants self-assessed extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All extremities pain severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
2593503|NCT02246166|Secondary|Headache Severity Assessment|Participants self-assessed headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All headache severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
2593504|NCT02246166|Secondary|Sore Throat Severity Assessment|Participants self-assessed sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sore throat severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.|Change from baseline in 15, 30, 60,120, 180, and 240 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
2593505|NCT02246166|Secondary|Global Assessment of Treatment|"After completing the 4 hours symptom severity assessments, participants evaluated their treatment response on a 5-point scale by answering the question: How well did the test medication control your symptoms? (0-ineffective, 1-poor, 2-fair, 3-good, or 4-excellent)."|4 hours|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Participants|||Number
2593506|NCT02246166|Primary|Symptom Severity Assessment at 4 Hours|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.~TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.~Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 4 hours post product use."|4 hours|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
2593507|NCT02246166|Primary|Symptom Severity Assessment at 3 Hours|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.~TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.~Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 3 hours post product use."|3 hours|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
2593508|NCT02246166|Primary|Symptom Severity Assessment at 2 Hours|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.~TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.~Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 2 hours post product use."|2 hours|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
2593509|NCT02246166|Primary|Symptom Severity Assessment at 1 Hour|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.~TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.~Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 1hour post product use."|1 hour|The primary population for assessment of efficacy was the intent to treat (ITT) population. The intent-to-treat (ITT) population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
2593553|NCT02244944|Secondary|Reduction in Hepatic Fat Fraction|Determine if Ezetimibe-Ursodiol combination therapy reduces total fat in the liver as assessed by MRI|6 months|The trial was terminated early. No data was collected to analyze the primary outcome measure.||||||
2605759|NCT02107014|Primary|Change in IL-5 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2593510|NCT02246166|Primary|Symptom Severity Assessment at 30 Minutes|"Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.~TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.~Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 30 minutes post product use."|30 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The intent-to-treat (ITT) population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
2593511|NCT02246166|Primary|Symptom Severity Assessment at 15 Minutes|"Symptom severity assessment was determined by Total Sum Score (TSS), TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.~TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.~Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 15 minutes post product use."|15 minutes|The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
2593512|NCT02246114|Primary|Primary Outcome of Serum Cotinine Levels|The primary outcome is the difference in serum cotinine levels between the intervention and control groups at the end of the trial.|1 year|Only 1 subject enrolled in this study and she terminated early due to miscarriage at 9 weeks.||||||
2593513|NCT02246062|Other Pre-specified|Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.|The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (> 30).|Immediately before induction of anesthesia||||units on a scale m-YPAS||Standard Deviation|Mean
2593514|NCT02246062|Other Pre-specified|Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure m-YPAS.|The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (> 30).|Immediately before entering operation room||||units on a scale m-YPAS||Standard Deviation|Mean
2593515|NCT02246062|Primary|Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.|The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (< 30).|24 hours before surgery||||units on a scale m-YPAS||Standard Deviation|Mean
2593516|NCT02246010|Secondary|Parental Satisfaction|Parental satisfaction with treatment on a Likert scale from 0 (not satisfied) to 10 (very satisfied).|7 days||||units on a scale||Standard Deviation|Mean
2593517|NCT02246010|Secondary|Hospitalization Rate|Rate of hospitalization|7 days||||Participants|||Count of Participants
2593518|NCT02246010|Secondary|Illness Visits|Number of participants with illness visits|7 days||||Participants|||Count of Participants
2593519|NCT02246010|Secondary|Weight Loss|Percent weight loss from baseline|7 days||||percent of body weight in kilogram||Standard Deviation|Mean
2593520|NCT02246010|Primary|Diarrhea Duration|number of days with 3 or more loose or watery stools|From onset of illness till the day of last diarrheic stool passed.||||Days||Standard Deviation|Mean
2593521|NCT02245737|Secondary|Pharmacokinetics (PK): Plasma Concentration of Lanabecestat||Week 4, post dose prior to departure from the clinic|All randomized participants who received at least one dose of study drug and have evaluable PK data.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2593522|NCT02245737|Secondary|Change From Baseline in Whole Brain Volume|Magnetic resonance imaging (MRI) was used to evaluate the effect of lanabecestat on whole brain volumes. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, baseline vMRI, intracranial volume, disease status at baseline and age at baseline.|Baseline, Week 104|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for Whole Brain Volume.|||cm^3 (cubic centimeter)||Standard Error|Least Squares Mean
2593523|NCT02245737|Secondary|Change From Baseline in Brain Metabolism Using Fluorodeoxyglucose (FDG)|Fluorodeoxyglucose (FDG) PET evaluates the regional brain metabolic rates for glucose as a sensitive, in vivo metabolic index of brain function. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the pons + vermis assessed with composite meta and composite meta automated anatomical labeling atlas (ALL). Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline. Baseline defined to be within 28 days of starting study drug.|Baseline, Week 104|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data of brain metabolism.|||Standard Uptake Value ratio (SUVr)||Standard Error|Least Squares Mean
2593554|NCT02244944|Secondary|Increase in Plasma Lathosterol|Determine if Ezetimibe-Ursodiol combination therapy promotes a net-negative sterol balance as evidenced by an increase in the cholesterol synthesis intermediate, lathosterol, in plasma.|6 months|The trial was terminated early. No data was collected to analyze the secondary outcome measure.||||||
2593524|NCT02245737|Secondary|Change From Baseline in Tau PET ((Flortaucipir F18)|Tau PET tracer (flortaucipir F18) longitudinal study measured whether lanabecestat, in participants with mild AD dementia, affected tau density and distribution over time. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the signal intensity in white matter. Annualized change is derived as change at LOCF divided by (LOCF date - baseline date) multiplied by 365. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline. Baseline defined to be within 28 days of starting study drug.|Baseline, Week 104|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for Tau PET.|||Standard Uptake Value ratio (SUVr)||Standard Error|Least Squares Mean
2593525|NCT02245737|Secondary|Change From Baseline in Brain Amyloid Burden Using Florbetapir Amyloid Positron Emission Tomography (PET) Scan|Amyloid deposition in the brain is one of the defining neuropathologic findings of Alzheimer's disease. Florbetapir exhibits high affinity specific binding to amyloid plaques. The change from baseline was measured as average standard uptake value ratio (SUVr) in prespecified regions of interest (ROI) assessed by florbetapir amyloid PET imaging in a subset of participants. The Centiloid scale standardizes quantitative brain amyloid PET results to allow cross-tracer and cross-methodology comparisons. The Centiloid scale anchor points are 0 and 100, where 0 represents a high-certainty amyloid negative scan and 100 represents the amount of global amyloid deposition found in a typical AD scans. Florbetapir SUVr was converted to the Centiloid scale using the following conversion: Florbetapir Centiloids = 183 x SUVr - 177. LS Mean was determined by ANCOVA methodology with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.|Baseline, Week 104|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for brain amyloid burden.|||Units on a scale||Standard Error|Least Squares Mean
2593526|NCT02245737|Secondary|Change From Baseline in CSF Phosphorylated Tau|Cerebrospinal fluid samples are collected for analysis of concentrations of phosphorylated tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.|Baseline, Week 97|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for CSF Phosphorylated Tau.|||Picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
2593527|NCT02245737|Secondary|Change From Baseline in CSF Total Tau|Cerebrospinal fluid samples are collected for analysis of concentration total tau. LS Mean was determined by ANCOVA with LOCF and with factors for treatment, disease status at baseline, baseline biomarker and age at baseline.|Baseline, Week 97|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for CSF Total Tau.|||Picogram per milliliter (pg/mL)||Standard Error|Least Squares Mean
2593528|NCT02245737|Secondary|PD: Percent Change From Baseline in Concentration of CSF Biomarker Aβ1-40|Concentration of the peptide Aβ 1-40 in plasma measured by immunoassay. LS Mean was determined by ANCOVA with LOCF (last observation carried forward), terms for treatment, baseline biomarker and age at baseline.|Baseline, Week 97|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for Aβ1-40.|||Percent change in Aβ1-40||Standard Error|Least Squares Mean
2593529|NCT02245737|Secondary|Pharmacodynamics (PD): Percent Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Biomarker Amyloid Beta (Aβ)1-42|Concentration of the peptide Aβ 1-42 in plasma measured by validated immunoassay. LS Mean was determined by Analysis of covariance (ANCOVA) with last observation carried forward (LOCF), terms for treatment, baseline biomarker and age at baseline.|Baseline, Week 97|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for Aβ1-42.|||Percent change in Aβ1-42||Standard Error|Least Squares Mean
2593530|NCT02245737|Secondary|Change From Baseline on the Mini-Mental State Examination (MMSE)|The MMSE is an instrument used to assess a participant's global cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline MMSE total score, age at baseline, and baseline MMSE total score-by-visit interaction.|Baseline, Week 104|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for MMSE.|||Units on a scale||Standard Error|Least Squares Mean
2593531|NCT02245737|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Score|The NPI is a questionnaire administered to caregivers that quantifies behavioral changes. Each of the 12 behavioral domains the caregiver reports as present are scored for Frequency, scale: 1 (Occasionally) to 4 (Very Frequently), and Severity, scale: 1 (Mild) to 3 (Severe). If the domain is reported by the caregiver as 'Not Affected,' that domain is scored as 0. The individual domain scores are calculated by multiplying the frequency times the severity for each domain. NPI Total Score is calculated by adding the individual domain scores together for all 12 domains, with a scores range from 0 to 144, with higher scores indicating greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline NPI score, age at baseline, and baseline NPI score-by-visit interaction.|Baseline, Week 104|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for NPI.|||Units on a scale||Standard Error|Least Squares Mean
2593532|NCT02245737|Secondary|Time to Progression as Measured by Loss of Clinical Dementia Rating (CDR) Global Score Stage|The CDR global score is a composite score calculated using the Washington University CDR-assignment algorithm applied to the 6 individual domain box scores (Morris 1993). The memory domain is considered the primary category that drives the CDR global outcome, and all other domains are secondary. The CDR global score ranges from 0 to 3 (0 = no dementia, 0.5 = questionable dementia, 1 = mild dementia, 2 = moderate dementia, 3 = severe dementia).|Baseline through Loss of 1 Global Stage or Week 104|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for CDR Global Score.|||Days||95% Confidence Interval|Median
2593533|NCT02245737|Secondary|Change From Baseline on the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score|"The CDR-SB is a rater administered scale and impairment is scored in of the following categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which no dementia = 0, questionable dementia = 0.5, mild dementia = 1, moderate dementia = 2 and severe dementia = 3. The 6 individual category ratings, or box scores, were added together to give the CDR-Sum of Boxes which ranges from 0-18, with higher scores indicating greater impairment. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline CDR-SB score, age at baseline, and baseline CDR-SB score-by-visit interaction."|Baseline, Week 104|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for CDR-SB.|||Units on a scale||Standard Error|Least Squares Mean
2593534|NCT02245737|Secondary|Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score|The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment-by- visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline iADRS13 total score, age at baseline, and baseline iADRS13 total score-by-visit interaction.|Baseline, Week 104|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for iADRS.|||Units on a scale||Standard Error|Least Squares Mean
2593535|NCT02245737|Secondary|Change From Baseline on the Functional Activities Questionnaire (FAQ) Score|FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from writing checks, assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean was calculated by MMRM with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline and pooled country.|Baseline, Week 104|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for FAQ score.|||Units on a scale||Standard Error|Least Squares Mean
2593536|NCT02245737|Secondary|Change From Baseline on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM model with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, pooled country, and covariates for baseline for baseline iADL score, age at baseline, and baseline iADL score-by-visit interaction.|Baseline, Week 104|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADCS-iADL measure.|||Units on a scale||Standard Error|Least Squares Mean
2593537|NCT02245737|Primary|Change From Baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)|ADAS-Cog13 (13-item version of ADAS-Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, pooled country, and covariates for baseline ADAS-Cog13 total score, age at baseline, and baseline ADAS-Cog13 total score-by-visit interaction.|Baseline, Week 104|All randomized participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADAS-Cog13 measure.|||Units on a scale||Standard Error|Least Squares Mean
2593538|NCT02245412|Secondary|PK: Area Under The Plasma (Or Serum) Concentration Versus Time Curve (AUC) Of IV ALXN1007|"The AUC of ALXN1007 was measured on Treatment Days 1, 28, and 49, from blood samples collected at time points relative to the dosing of ALXN1007. PK assessments were to have been measured from Baseline, Treatment Days 7, 14, 21, 28, 35, 42, 49, 56, and Follow-up Days 86, 180, and Early Termination (ET).~Due to the early termination of the study and the clinical development of the ALXN1007 program, a number of PK analyses were not completed. PK data for the 20 mg/kg ALXN1007 once weekly dosing group and the 20 mg/kg ALXN1007 twice weekly dosing group are not available."|Predose up to 72 hours postdose|PK population: All participants in the 10 mg/kg ALXN1007 once weekly dose group who received at least 1 dose of ALXN1007 and who had evaluable PK and PD data.|||h*ug/mL||Full Range|Median
2593539|NCT02245412|Secondary|PK: Maximum Observed Concentration In Plasma (Cmax) Of IV ALXN1007|"The Cmax of ALXN1007 was measured on Treatment Days 1, 28, and 49, from blood samples collected at time points relative to the dosing of ALXN1007. PK assessments were to have been measured from Baseline, Treatment Days 7, 14, 21, 28, 35, 42, 49, 56, and Follow-up Days 86, 180, and Early Termination (ET).~Due to the early termination of the study and the clinical development of the ALXN1007 program, a number of PK analyses were not completed. PK data for the 20 mg/kg ALXN1007 once weekly dosing group and the 20 mg/kg ALXN1007 twice weekly dosing group are not available."|Predose up to 72 hours postdose|PK population: All participants in the 10 mg/kg ALXN1007 once weekly dose group who received at least 1 dose of ALXN1007 and who had evaluable PK and PD data.|||ug/mL||Full Range|Median
2594362|NCT02233738|Secondary|Short Inventory of Problems at 6 Months|Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use|6 months||||score on a scale||Standard Deviation|Mean
2593540|NCT02245412|Secondary|Pharmacokinetics (PK): Time To Maximum Observed Concentration In Plasma (Tmax) Of IV ALXN1007|"The Tmax of ALXN1007 was measured on Treatment Days 1, 28, and 49, from blood samples collected at time points relative to the dosing of ALXN1007. PK assessments were to have been measured from Baseline, Treatment Days 7, 14, 21, 28, 35, 42, 49, 56, and Follow-up Days 86, 180, and Early Termination (ET).~Due to the early termination of the study and the clinical development of the ALXN1007 program, a number of PK analyses were not completed. PK data for the 20 mg/kg ALXN1007 once weekly dosing group and the 20 mg/kg ALXN1007 twice weekly dosing group are not available."|Predose up to 72 hours postdose|PK population: All participants in the 10 mg/kg ALXN1007 once weekly dose group who received at least 1 dose of ALXN1007 and who had evaluable PK and pharmacodynamic (PD) data.|||hours||Full Range|Median
2593541|NCT02245412|Primary|Overall Acute Graft-Versus-Host Disease (GVHD) Response Rate At Day 28|The number of participants with overall acute GVHD response was determined at Day 28. Acute Overall GVHD is defined as improvement from diagnosis in any organ by at least 1 stage, without progression in any other organ, and with no additional therapy being administered. Acute GVHD staging included skin, liver, and GI assessments, which were to be performed using the Modified Keystone Grading Schema. Deaths were considered nonresponders; otherwise last postbaseline values were carried forward for imputation of missing responses. Modified Keystone Grading Schema: Skin - Stages 0 = No Rash, 1 = Rash <25% body surface area (BSA), 2 = 25% to 50% BSA, 3 = >50% BSA, 4 = bullae, desquamation; Lower GI Tract (stool volume over 24 hours) - Stages 0 = <500 mL, 1 = 500 to 1000 mL, 2 = 1001 to 1500 mL, 3 = >1500 mL, 4 = severe abdominal pain +/- ileus, frank blood, or melena; Liver (bilirubin levels) - Stages 0 = ≤2 mg/dL, 1 = 2.1 to 3 mg/dL, 2 = 3.1 to 6 mg/dL, 3 = 6.1 to 15 mg/dL, 4 = >15 mg/dL.|Day 28|Participants in the mFAS Population - In the 10 mg/kg ALXN1007 once weekly dose group, 1 participant was prematurely discontinued after receiving a single dose due to lack of confirmed GI GVHD.|||Participants|||Count of Participants
2593542|NCT02245360|Secondary|Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment|measurement of IgE in serum|baseline versus end of treatment (approx. 60 days)|In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data.|||UA/ml||Standard Deviation|Mean
2593543|NCT02245360|Primary|The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum|measurement of IgG4 in serum|baseline versus end of treatment (approx. 60 days)|In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data.|||mgA/L||Standard Deviation|Mean
2593544|NCT02245308|Secondary|Intervention Delivery Costs|Intervention delivery costs (including medication costs, supplies, and incentive pay for abstinence) will be evaluated for treatment and control group.|6 months||||dollars||Standard Deviation|Mean
2593545|NCT02245308|Primary|Number of Participants Self-reported and Bioverified Abstinent From Smoking|Smoking abstinence at six months will be measured by self-report and bio-verified by salivary cotinine (a by-product of nicotine found in saliva).|6 months|All participants who were randomized to treatment were included in the final analysis of bioverified abstinence, using an intent-to-treat sample where missing = smoking|||Participants|||Count of Participants
2593546|NCT02245217|Primary|RECIST 1.1 Therapeutic Responses to 1 Cycle|The patients underwent baseline and repeat PET/CT imaging (after one cycle) with FDG and FLT. Tumor response was determined by RECIST 1.1 and defined as a >30% reduction in tumor size as determined by the sum of the longest diameters of each index lesion|1 month||||participant responses based on RECIST1.1|||Number
2593547|NCT02245217|Primary|FLT Therapeutic Responses to 1 Cycle|The patients underwent baseline and repeat PET/CT imaging (after one cycle) with FDG and FLT. The percent change in the SUVmax for FLT was determined. From these percent change determinations, a response determination was obtained based on the EORTC criteria. EORTC response criteria define a response as >25% reduction in SUVmax.|1 month|Patients who completed both baseline and follow-up imaging. A synthesis failure for FLT occurred on the follow-up imaging for one patient, so that patient was excluded from the FLT analysis.|||participant responses based on EORTC|||Number
2593548|NCT02245217|Primary|FDG Therapeutic Responses to 1 Cycle|The patients underwent baseline and repeat PET/CT imaging (after one cycle) with fluorodeoxyglucose (FDG) and fluorothymidine (FLT). The percent change in the SUVmax for FDG was determined. From these percent change determinations, a response determination was obtained based on the EORTC criteria. EORTC response criteria define a response as >25% reduction in SUVmax.|1 month||||participant responses based on EORTC|||Number
2593549|NCT02244996|Secondary|Implicit Times of Flash Electroretinogram|"The cone responses from electroretinogram will be measured at the time point of baseline and 12 months. The cone response is related to the activity of the cone photoreceptor under light stimulation.~The change of cone response b-wave implicit time (ms) between 12-month and baseline will be provided to show the effect of interventions. The b-wave implicit time is to measure the physiological changes of cone cells in the retina.~The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum."|12 months||||msec||Standard Deviation|Mean
2593550|NCT02244996|Secondary|Amplitudes of Flash Electroretinogram|"The cone responses from electroretinogram will be measured at the time point of baseline and 12 months. The cone response is related to the activity of the cone photoreceptor under light stimulation.~The change of cone response b-wave amplitude (uV) between 12-month and baseline will be provided to show the effect of interventions. The b-wave amplitude is to measure the magnitude of electrical responses of cone cells in the retina.~The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum."|12 months||||uV||Standard Deviation|Mean
2593551|NCT02244996|Secondary|Visual Field Sensitivity|"Humphrey Visual Field Analyser will be used to measure the brightness sensitivity across the central 30 degree visual field at time point of baseline and 12 months. Visual field is to measure the size of the field of view and the sensitivity of the corresponding locations of the field of view.~The change of sensitivity (dB) between 12-month time point and baseline will be provide to show the effects of interventions.~The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum"|12 months||||dB||Standard Deviation|Mean
2593555|NCT02244944|Primary|Reduction in Serum Alanine Transaminase (ALT)|Determine if Ezetimibe-Ursodiol combination therapy improves liver function tests (ALT)|6 months|The trial was terminated early. No data was collected to analyze the primary outcome measure.||||||
2593569|NCT02244619|Secondary|Patient-rated Pain in the Post-operative Period|Patient-rated pain in the post-operative period was collected using a 10-point visual analog scale (VAS). A score of 0 indicates no pain; higher scores indicate greater pain. Minimum score for each VAS measurement is 0; Maximum score for each VAS measurement is 10. VAS scores were averaged for each patient.|Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery||||Visual analog pain scale (0-10)||Inter-Quartile Range|Median
2593570|NCT02244619|Primary|Total Post-operative Use of Opioids|Post-operative use of opioids, measured in morphine milligram equivalent (MME) units|During post-op period up to 24 hrs after surgery||||Morphine milligram equivalents (MME)||Inter-Quartile Range|Median
2593571|NCT02244580|Secondary|Number of Patients With Ki-67 Determined by MammaTyper™ Compared to Local Ki-67 Eyeballed Assessment for Luminal Tumors and Correlation to Rate of Patients With Regard to OS and DDFS|Superiority of outcome prediction for MammaTyper™ Ki-67 over local Ki-67 eyeballed assessment for Luminal tumors with regard to OS and DDFS|5 years||||Hazard ratio||95% Confidence Interval|Number
2593572|NCT02244580|Secondary|Number of Patients With High Ki-67 and Prognosis on Outcome for DDFS and OS (Measured by Hazard Ratio)|High Ki-67 is prognostic for worse outcome for DDFS and OS (measured by hazard ratio)|5 years||||Hazard ratio||95% Confidence Interval|Number
2593573|NCT02244580|Primary|5 Year Distant Disease Free Survival (DDFS) Assessed as Rate of Patients Without Distant Metastases in Subgroup Luminal A vs. Combined Subgroup (Luminal B, HER2 Positive, Triple Negative), Based on Subtyping With MammaTyper™|Tumor material of breast cancer patients will be newly assessed by MammaTyper™ and 5 year DDFS will be calculated new according to new subgrouping (Luminal A vs. combined subgroup (Luminal B, HER2 positive, triple negative))|5 year from the date of patient randomisation||||percentage of analyzed participants|||Number
2593574|NCT02244424|Primary|Change in Infant Growth|Recumbent infant length (inches) and weight (pounds/ounces) measured at three separate time points. While recumbent infant length was collected in inches and weight collected in pounds/ounces, these measures were converted into z-score measurements for the outcome measurement of change in infant growth. Standardized weight scores are measures of relative weight adjusted for child age and sex. The z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A z-score of 0 is equal to the mean. Negative numbers indicated weight values lower than the mean and the positive numbers indicate weight values higher than the mean.|Baby is less than 2 months; baby is 3 months; baby is 6 months|82 participants were included in analysis at Time 1, 79 at Time 2, and 67 at Time 3. This is due to participants lost to follow-up.|||Weight for age Z-score||Standard Deviation|Mean
2593575|NCT02243943|Secondary|Sedation|using the Leiden observer alertness score (1 alert - 5 sedated)|45 minutes post surgery||||sedation scale (1 alert - 5 sedated)||95% Confidence Interval|Mean
2593576|NCT02243943|Secondary|Pain|using the 1-10 numeric rating scale|45 minutes post surgery||||Numeric rating scale. 1(low)-10(maximum)||95% Confidence Interval|Mean
2593577|NCT02243943|Primary|Mean Lowest Saturation|Mean saturation is the mean value of the beat-to-beat Hb-oxygen saturation measured by finger pulse oximeter as measured in the first 45 min in the recovery room following surgery|45 minutes post surgery||||percentage of oxygen saturation||95% Confidence Interval|Mean
2593578|NCT02243696|Secondary|Protego DF4 Lead Pacing Impedance|Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up.|5 years||||Ohms||Standard Deviation|Mean
2593579|NCT02243696|Secondary|Protego DF4 Lead Sensing|Sensing measurements for the Protego DF4 leads through 5 years of follow-up.|5 years||||millivolts||Standard Deviation|Mean
2593580|NCT02243696|Secondary|Adverse Event Rate for Adverse Events Excluded From Primary Objectives|The overall incidence of all other adverse events that were excluded from the primary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR).|5 years|On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing Protego DF4 Post Approval Registry to a new EP PASSION real-world data methodology. Therefore, this outcome measure was not completed.||||||
2593581|NCT02243696|Secondary|Protego DF4 Lead Shock Impedance|Shock impedance measurements for the Protego DF4 leads through 5 years of follow-up.|5 years||||Ohms||Standard Deviation|Mean
2593582|NCT02243696|Secondary|Protego DF4 Lead Pacing Threshold Measurement|Pacing threshold measurements at pulse width of 0.4 or 0.5 ms for the Protego DF4 leads through 5 years of follow-up.|5 years||||volts||Standard Deviation|Mean
2593583|NCT02243696|Primary|Protego DF4 Lead Safety-Individual Adverse Event-Free Rate|Evaluate the individual types of adverse events contributing to primary outcome measure 'Protego DF4 Lead Safety-Overall Adverse Event-Free Rate'.|5 years|On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing Protego DF4 Post Approval Registry to a new EP PASSION real-world data methodology. Therefore, this outcome measure was not completed.||||||
2593584|NCT02243696|Primary|Protego DF4 Lead Safety-Overall Adverse Event-Free Rate|Evaluate the overall incidence of adverse events related to the Protego DF4 lead or header through 5 years. The endpoint is analyzed as the adverse event free-rate.|5 years|On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing Protego DF4 Post Approval Registry to a new EP PASSION real-world data methodology. Therefore, this outcome measure was not completed.||||||
2593585|NCT02243579|Secondary|Incidence of Adverse Events Graded Using the Common Terminology Criteria for Adverse Events Version 5.0|Adverse events were summarized as counts and frequencies by toxicity grade.|Up to 4 years||||Participants|||Count of Participants
2593586|NCT02243579|Secondary|Time to Onset of First Drug-related Toxicity|Summary statistics (mean and SD) for time to onset of first drug-related toxicity was provided.|Up to 4 years|Patients with drug-related toxicities included in the analysis|||Days||Standard Deviation|Mean
2593587|NCT02243579|Secondary|Overall Survival (OS)|Was estimated using the Kaplan-Meier method (Overall Survival Probability).|The time from randomization to death due to any cause, assessed at 52, 104 and 156 weeks||||Overall Survival Probability|||Number
2593588|NCT02243579|Secondary|Progression Free Survival (PFS)|Was estimated using the Kaplan-Meier method (Progression Free Survival Probability).|The time from allocation to the first documented disease progression or death due to any cause, whichever occurs first, assessed at 26 and 52 weeks||||Progression Free Survival Probability|||Number
2594363|NCT02233738|Secondary|Short Inventory of Problems at 3 Months|Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use|3 months||||score on a scale||Standard Deviation|Mean
2593589|NCT02243579|Secondary|Duration of Response|Was estimated using the Kaplan-Meier method (Duration of Response Probability).|The time interval between the date of first response (CR/PR) and the date of progression as assessed by standard Mycosis Fungoides and Sezary Syndrome response criteria, assessed at 26 and 52 weeks||||Duration of Response Probability|||Number
2593590|NCT02243579|Primary|Objective Response Rate (ORR), Defined as a Confirmed Partial Response (PR) or Complete Response (CR) Using Global Assessment Standard Response Criteria for Mycosis Fungoides and Sezary Syndrome|A generalized linear model for the objective response rate used a binominal error distribution. The model included as covariates all available baseline predictors of the missing outcomes.|Up to 3.2 years||||Participants|||Count of Participants
2593591|NCT02243527|Other Pre-specified|Muscle Oxygenation|Using near-infrared spectroscopy to examine if there are any relative changes in concentration (∆umol/Litre) of deoxygenated hemoglobin (HHb) after training. Deoxygenated hemoglobin is used as a surrogate of oxygen extraction specific to the local vasculature of the vastus lateralis,|Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training||||change in umol/Litre HHb||Standard Deviation|Mean
2593592|NCT02243527|Other Pre-specified|Dyspnoea|"Using the modified Borg scale to assess changes in perceived dyspnoea after inspiratory muscle training.~The modified Borg scale is a 0-10 category ratio scale. The floor (0) of the scale is anchored subjectively to the subjects interpretation of no breathing discomfort at all, and the ceiling (10) to represent the most intense breathing discomfort they have experienced or could imagine experiencing."|Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training||||Borg Units||Standard Deviation|Mean
2593593|NCT02243527|Secondary|Accessory Respiratory Muscle Activation|"Using surface electromyography to determine the activation patterns of accessory respiratory muscles (scalene and sternocleidomastoid).~Data are expressed as %max. This value is determined by taking the average electromyography (EMG) activity divided by the maximal EMG activity generated during a maximal inspiratory maneuver (inspiratory capacity during exercise)."|Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training||||%max||Standard Deviation|Mean
2593594|NCT02243527|Primary|Diaphragm Electromyography|"Using a multipair esophageal electrode catheter we will determine any changes to the electric activity of the diaphragm.~Diaphragm electromyography (EMG) has been expressed as %max. This unit is determined as the ratio of average EMG value (uV) divided by the maximal EMG activity (uV) generated during a maximal respiratory maneuver (inspiratory capacity during exercise)."|Post Intervention - ie. immediately after 5 weeks of inspiratory muscle training||||%max||Standard Deviation|Mean
2593595|NCT02243371|Secondary|Tumor Marker Kinetics (CA 19-9) in Patients With Baseline Abnormal Levels as Measured by Number of Participants With Stable or Responding CA19-9 Concentration|Number of participants with stable or responding (<50% increase of serum CA19-9 concentration) at 120 days.|120 days||||Participants|||Count of Participants
2593596|NCT02243371|Secondary|Number of Participants With Partial Response (PR) or Complete Response (CR) as Defined by RECIST 1.1 in Metastatic Pancreatic Cancer Patients|Per RECIST 1.1 criteria, PR is defined as =>30% decrease in sum of diameters of target lesions and CR is the disappearance of all target lesions.|2 years and 7 months||||Participants|||Count of Participants
2593597|NCT02243371|Secondary|Time to Progression (TTP) by RECIST 1.1 in Metastatic Pancreatic Cancer Patients|Time to progression (TTP) is defined as the time from randomization to the date of documented disease progression as defined by RECIST 1.1 criteria. Individuals are censored at the date of the last radiological assessment that occurs prior to any of the following: death, switch to another anti-cancer therapy, or end of follow-up. Individuals without follow-up or baseline measurements are censored at 1 day. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.|2 years and 7 months||||months||95% Confidence Interval|Median
2593598|NCT02243371|Secondary|Immune-related Progression-free Survival (irPFS) by IRRC in Metastatic Pancreatic Cancer Patients|irPFS is defined as the number of months from the date of randomization to disease progression (PD or relapse from CR as assessed using irRC RECIST 1.1 criteria) or death due to any cause. Per irRC criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in tumor burden compared with baseline, Progressive Disease (PD) is >20% increase in tumor burden compared with nadir, Stable Disease (SD) is <30% decrease in tumor burden compared with baseline or <20% increase in tumor burden compared to nadir.|2 years and 7 months||||months||95% Confidence Interval|Mean
2593599|NCT02243371|Secondary|Progression-free Survival (PFS) in Metastatic Pancreatic Cancer Patients|PFS is defined as the number of months from the date of randomization to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.|2 years and 7 months||||months||95% Confidence Interval|Median
2593600|NCT02243371|Secondary|Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity|When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject.|2 years and 7 months||||Participants|||Count of Participants
2593601|NCT02243371|Primary|Overall Survival (OS)|OS will be measured from date of randomization until death or end of followup (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis).|2 years and 7 months||||months||95% Confidence Interval|Median
2593602|NCT02243306|Secondary|Plasma Concentration of Hepcidin|Serial blood samples were collected from participants at indicated time points to analyze plasma concentration of hepcidin after repeat-dose administration of GSK1278863. Geometric mean and geometric coefficient of variation have been presented. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose and 4, 8 ,12, 24 hours post-dose on Day 1 and Day 14; Pre-dose on Day 3, 7, 11|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).|||Micrograms per liter||Geometric Coefficient of Variation|Geometric Mean
2593603|NCT02243306|Secondary|Plasma Concentration of Erythropoietin|Serial blood samples were collected from participants at indicated time points to analyze plasma concentration of erythropoietin after repeat-dose administration of GSK1278863. Geometric mean and geometric coefficient of variation have been presented. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose and 4, 8 ,12, 24 hours post-dose on Day 1 and Day 14; Pre-dose on Day 3, 7, 11|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).|||IU/L||Geometric Coefficient of Variation|Geometric Mean
2593604|NCT02243306|Secondary|Time Invariance Ratio of GSK1278863 and Metabolites|Time invariance ratio for GSK1278863 and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401) was calculated by analyzing AUC (0-inf) at Day 1 and AUC (0-tau) at Day 14. Analysis was performed using mixed effect model fitted with day (single and repeat dose) as fixed effect and participant as random effect. Mean ratio and 90% confidence intervals have been presented. NA indicates data is not available. Data could not be calculated due to insufficient data.|Day 1 and Day 14|PK Population. CAPD and APD arms were combined to present data for all participants analyzed.|||Ratio of AUC||90% Confidence Interval|Mean
2593605|NCT02243306|Secondary|Accumulation Ratio of GSK1278863 and Metabolites|The observed accumulation ratio was determined to estimate the extent of accumulation for GSK1278863 and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401) after repeat dosing. Accumulation ratio was calculated by using AUC (0-tau) values at Day 1 and Day 14. Analysis was performed using mixed effect model fitted with day (single and repeat dose) as fixed effect and participant as random effect. Mean ratio and 90% confidence intervals have been presented.|Day 1 and Day 14|PK Population. CAPD and APD arms were combined to present data for All participants analyzed.|||Ratio of AUC||90% Confidence Interval|Mean
2593606|NCT02243306|Secondary|Time of Occurrence of Cmax (Tmax) of GSK1278863 and Metabolites|Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401). Median and full range have been presented for all metabolites. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14|PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).|||Hour||Full Range|Median
2593607|NCT02243306|Secondary|Terminal Phase Half-life (t 1/2) of GSK1278863 and Metabolites|Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403, GSK2531401). Geometric mean and geometric coefficient of variation have been presented for all metabolites. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants, which is indicated by NA. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14|PK Population. Only participants available at specified time points were analyzed. Due to lack of quantifiable plasma concentrations in terminal elimination phase (Day 1) of 4 metabolites GSK2391220,GSK2506102,GSK2531403,GSK2531401, terminal slope(lambda z) could not be determined,thus t1/2 could not be calculated as it depends on lambda z value.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2593608|NCT02243306|Secondary|Peritoneal Dialysis Clearance of GSK1278863 and Metabolites|Peritoneal dialysate samples for PK analysis of GSK1278863 and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401) were collected. Peritoneal dialysis clearance of GSK1278863 and metabolites was calculated from Day 14 dialysate excretion data as total amount of analyte excreted over 24 hours divided by plasma AUC (0-tau). Geometric mean and geometric coefficient of variation are presented. NA indicates data is not available. Geometric coefficient of variation could not be calculated due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Day 14|PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).|||Milliliter per hour||Geometric Coefficient of Variation|Geometric Mean
2593609|NCT02243306|Secondary|Number of Participants With Abnormal Physical Examination Findings|A complete physical examination was planned to include assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities. This analysis was planned but not performed. Any significant finding was captured as an AE.|Up to Day 17|All Subjects Population||||||
2593610|NCT02243306|Secondary|Change From Baseline in Body Temperature|Vital sign measurements including body temperature were taken in a supine position after at least 5 minutes of rest. Change from Baseline in body temperature at Day 17 and Day 24 (follow-up) are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline, Day 17 and Day 24|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).|||Degree celsius||Standard Deviation|Mean
2593611|NCT02243306|Secondary|Change From Baseline in Pulse Rate|Vital sign measurements including pulse rate were taken in a supine position after at least 5 minutes of rest. Change from Baseline in pulse rate at Day 17 and Day 24 (follow-up) are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline, Day 17 and Day 24|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).|||Beats per minute||Standard Deviation|Mean
2593612|NCT02243306|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital sign measurements including SBP and DBP were taken in a supine position after at least 5 minutes of rest. Change from Baseline in SBP and DBP at Day 17 and Day 24 (follow-up) are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline, Day 17 and Day 24|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).|||Millimeters of mercury||Standard Deviation|Mean
2593613|NCT02243306|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Single measurements of 12-lead ECG were obtained in supine position after at least 10 minutes of rest using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT (QTc) interval. Participants with abnormal ECG findings at worst-case observation Carried Forward for triplicate measurements (WOCF) post-Baseline visit are presented. Only participants with data available at WOCF visit were analyzed.|Day 17|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2593614|NCT02243306|Secondary|Change From Baseline in Mean Corpuscular Hemoglobin (MCH) Levels|Blood samples were collected from participants to evaluate clinical hematology parameters including MCH. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.|Baseline and Day 17|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Picograms||Standard Deviation|Mean
2593615|NCT02243306|Secondary|Change From Baseline in Mean Corpuscular Volume (MCV)|Blood samples were collected from participants to evaluate clinical hematology parameters including MCV. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.|Baseline and Day 17|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Femtoliter||Standard Deviation|Mean
2593616|NCT02243306|Secondary|Change From Baseline in Mean Corpuscular Hemoglobin Concentration (MCHC)|Blood samples were collected from participants to evaluate clinical hematology parameters including MCHC. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.|Baseline and Day 17|All Subjects Population. Only those participants available at the specified time points were analyzed.|||g/L||Standard Deviation|Mean
2593617|NCT02243306|Secondary|Change From Baseline in Hemoglobin Levels|Blood samples were collected from participants to evaluate clinical hematology parameters including hemoglobin. Change from Baseline in clinical hematology parameters at Day 3, Day 7, Day 11 and Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Day 3, 7, 11, 17|All Subjects Population. Only those participants available at the specified time points were analyzed.|||g/L||Standard Deviation|Mean
2593618|NCT02243306|Secondary|Change From Baseline in Hematocrit Levels|Blood samples were collected from participants to evaluate clinical hematology parameters including hematocrit. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.|Baseline and Day 17|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2593619|NCT02243306|Secondary|Change From Baseline in Erythrocyte and Reticulocyte Levels|Blood samples were collected from participants to evaluate clinical hematology parameters including erythrocyte and reticulocyte. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. NA indicates data is not available. Mean and standard deviation are presented. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.|Baseline and Day 17|All Subjects Population. Only those participants available at the specified time points were analyzed.|||10^12 cells/liter||Standard Deviation|Mean
2593620|NCT02243306|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes Levels|Blood samples were collected from participants to evaluate clinical hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Change from Baseline in clinical hematology parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. NA indicates data is not available. Mean and standard deviation are presented. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.|Baseline and Day 17|All Subjects Population. Only those participants available at the specified time points were analyzed.|||10^9 cells/liter||Standard Deviation|Mean
2593621|NCT02243306|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) and Creatinine Kinase Levels|Blood samples were collected from participants to evaluate clinical chemistry parameters including ALT and creatinine kinase. Change from Baseline in clinical chemistry parameters at Day 3, Day 7, Day 11, Day 14 and Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and Day 3, 7, 11, 14, 17|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).|||IU/L||Standard Deviation|Mean
2593622|NCT02243306|Secondary|Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Gamma Glutamyl Aminotransferase (GGT) Levels|Blood samples were collected from participants to evaluate clinical chemistry parameters including ALP, AST and GGT. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.|Baseline and Day 17|All Subjects Population. Only those participants available at the specified time points were analyzed.|||International unit per liter (IU/L)||Standard Deviation|Mean
2593623|NCT02243306|Secondary|Change From Baseline in Direct Bilirubin, Bilirubin, Creatinine and Urate Levels|Blood samples were collected from participants to evaluate clinical chemistry parameters including direct bilirubin, bilirubin, creatinine and urate. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.|Baseline and Day 17|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Micromoles per liter||Standard Deviation|Mean
2593624|NCT02243306|Secondary|Change From Baseline in Albumin and Protein Levels|Blood samples were collected from participants to evaluate clinical chemistry parameters including albumin and protein. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.|Baseline and Day 17|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Gram per liter (g/L)||Standard Deviation|Mean
2593625|NCT02243306|Secondary|Change From Baseline in Glucose, Calcium, Chloride, Carbon-dioxide (CO2), Potassium, Sodium and Urea Levels|Blood samples were collected from participants to evaluate clinical chemistry parameters including glucose, calcium, chloride, CO2, potassium, sodium and urea. Change from Baseline in clinical chemistry parameters at Day 17 are presented. Day-1 was considered as Baseline value. Change from Baseline was calculated as post-randomization values minus Baseline value. Mean and standard deviation are presented. NA indicates data is not available. Standard deviation could not be calculated for CAPD cohort due to small number of participants. Only participants with data available at the specified time point were analyzed.|Baseline and Day 17|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Millimoles per liter||Standard Deviation|Mean
2593626|NCT02243306|Secondary|Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth defect, other situations, and is associated with liver injury and impaired liver function. Analysis was performed on All Subjects Population which comprised of all enrolled participants who received at least one dose of study treatment.|Up to Day 24|All subjects Population|||Participants|||Number
2593627|NCT02243306|Primary|Maximum Observed Concentration (Cmax) of GSK1278863 and Its Metabolites|Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401). Geometric mean and geometric coefficient of variation has been presented for all metabolites. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14|PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2593628|NCT02243306|Primary|AUC From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-inf]) of GSK1278863 and Its Metabolites|Serial blood samples were collected from participants at indicated time points for PK analysis of GSK1278863 and its metabolites (GSK2487818 and GSK2531398). Geometric mean and geometric coefficient of variation has been presented for all metabolites. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants.|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|PK Population|||Hour into nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2593640|NCT02243202|Other Pre-specified|Change From Baseline in Pulse Rate at Week 26|Change from baseline in pulse rate at week 26|Week 26|The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Beats Per Minute (Beats/Min)||Standard Error|Least Squares Mean
2593629|NCT02243306|Primary|Area Under the Concentration-time Curve (AUC) Over the Dosing Interval (AUC[0-tau]) of GSK1278863 and Its Metabolites|Serial blood samples were collected from participants at indicated time points for Pharmacokinetic (PK) analysis of GSK1278863 and its metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531403 and GSK2531401). Geometric mean and geometric coefficient of variation has been presented for all metabolites. NA indicates data is not available. Geometric coefficient of variation could not be calculated for CAPD cohort due to small number of participants. PK Population comprised of participants in the 'All Subjects' Population for whom a PK sample was obtained and analyzed.|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1; Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose on Day 14|PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in category titles).|||Hour into nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2593630|NCT02243293|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug (ITT population) with evaluable data, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
2593631|NCT02243293|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Up to end of treatment (treatment week 8, 12 or 16 depending on arm) or premature discontinuation from treatment|All participants who received at least 1 dose of study drug (ITT population) with evaluable data.|||percentage of participants||95% Confidence Interval|Number
2593632|NCT02243293|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)|SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.|4 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2593633|NCT02243293|Primary|Percentage of Genotype 2 (GT2) Direct-acting Antiviral Agents (DAA)-Naive Participants (in Part 4, Arm S1) With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) as Compared to Historical Control|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2593634|NCT02243293|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population) with evaluable data; participants with missing data after backwards imputation were imputed as nonresponders.|||percentage of participants||95% Confidence Interval|Number
2593635|NCT02243280|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit|||percentage of participants||95% Confidence Interval|Number
2593636|NCT02243280|Secondary|Percentage of Participants With On-treatment Virologic Failure|The percentage of participants with on-treatment virologic failure (defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment), confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.|Screening, Day 1, Day 3, treatment weeks 1, 2, 4, 6, 8, 10, and 12 or premature discontinuation from treatment|Intention-to-treat population: all participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2593637|NCT02243280|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) 4 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.|4 weeks after the last actual dose of study drug|Intention-to-treat population: all participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2593638|NCT02243280|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|Intention-to-treat population: all participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2593639|NCT02243202|Other Pre-specified|Percentage of Participants With Weight Loss More Than Equal to (>=) 10 Percent at Week 26|Percentage of participants with weight loss >= 10 percent at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent.|||Percentage of Participants|||Number
2593785|NCT02241512|Other Pre-specified|24-h Post-ERCP Pain Score|Pain score recorded 24-hrs after the ERCP was performed as recorded on a 10-point Likert pain scale (0= lowest value, no pain, 10=highest value, severe pain)|pre-procedural, 24 hours||||score on a Likert pain scale||Inter-Quartile Range|Mean
2593641|NCT02243202|Other Pre-specified|Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26|Change from baseline in diastolic blood pressure (DBP) at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
2593642|NCT02243202|Secondary|Absolute Change From Baseline in Body Weight at Week 26|Absolute change from baseline in body weight was analysed at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Kilogram (Kg)||Standard Error|Least Squares Mean
2593643|NCT02243202|Secondary|Change From Baseline in Systolic Blood Pressure at Week 26|Change from baseline in systolic blood pressure was analysed at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||mmHg (millimeters of mercury)||Standard Error|Least Squares Mean
2593644|NCT02243202|Secondary|Percentage of Participants With Weight Loss More Than Equal to (>=) 5 Percent at Week 26|Percentage of participants with weight loss >= 5 percent were analysed at week 26.|Week 26|The mITT analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2593645|NCT02243202|Primary|Percent Change From Baseline in Body Weight at Week 26|The percent change from baseline in body weight at Week 26 was analysed.|Week 26|The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of double-blind study agent. N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Percent Change||Standard Error|Least Squares Mean
2593646|NCT02243176|Secondary|Change From Baseline in Body Weight|Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24|From baseline to 24 week|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.|||kg||Standard Error|Least Squares Mean
2593647|NCT02243176|Secondary|Change From Baseline in HOMA-β|Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function was estimated by the Homeostasis model assessment-β (HOMA-β), which was defined as fasting insulin (mU/mL) x 20 / (fasting glucose (mmol/mL) - 3.5, body weight at week 24|From baseline to 24 week|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.|||mU/mmol||Standard Error|Least Squares Mean
2593648|NCT02243176|Secondary|Change From Baseline in 2H Postprandial Glucose (2HPPG)|Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24|From baseline to 24 week|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.|||mmol/l||Standard Error|Least Squares Mean
2593649|NCT02243176|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Secondary objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure change from baseline in fasting plasma glucose, 2h postprandial glucose, β-cell function, body weight at week 24|From baseline to 24 week|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.|||mmol/l||Standard Error|Least Squares Mean
2593650|NCT02243176|Secondary|Proportion (%) of Patients Achieving HbA1c<7.0% Without GI Adverse Events|Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients achieving HbA1c<7.0% without GI adverse events.|Whole study duration|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.|||percentage of participants|||Number
2593651|NCT02243176|Secondary|Proportion (%) of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c<7.0%|Secondary Objective: Effects of saxagliptin versus acarbose on the additional parameters, by measure proportion (%) of patients achieving a therapeutic glycemic response defined as HbA1c<7.0%|24 weeks|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.|||percentage of participants|||Number
2593652|NCT02243176|Secondary|Proportion (%) of Patients With Any GI Adverse Events|Secondary Objective: Assessment of any gastrointestinal adverse events of saxagliptin versus acarbose. by measure proportion (%) of patients with any gastrointestinal adverse events.|24 weeks|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.|||percentage of participants|||Number
2593653|NCT02243176|Primary|Absolute Change From Baseline in HbA1c at Week 24 (DAO)|The primary endpoint was analyzed based on Per protocol analysis set as the supportive analysis.|From baseline to 24 week|The Per Protocol analysis set was a subset of the Full analysis set that included subjects who did not have significant protocol deviations that affect the study outcome. The exclusions from the PP analysis set was determined prior to database lock.|||% (HbA1c)||Standard Error|Least Squares Mean
2593654|NCT02243176|Primary|Absolute Change From Baseline in HbA1c at Week 24 (DAO)|Primary Objective: Efficacy of saxagliptin plus metformin on glycemic control compared with acarbose plus metformin in patients with T2D inadequately controlled with metformin. By Measure absolute change from baseline in HbA1c at Week 24|From baseline to 24 week|The Full analysis set included all randomized subjects who took at least 1 randomized IP dose, and had at least 1 non-missing baseline and 1 post-baseline efficacy data assessments.|||% (HbA1c)||Standard Error|Least Squares Mean
2593786|NCT02241512|Other Pre-specified|Increased Pain Score|Number of patients with increased pain scores after the procedure|pre-procedural, 24 hours||||Participants|||Count of Participants
2593655|NCT02243046|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 months (from Baseline)||||units on a scale||Standard Deviation|Mean
2593656|NCT02243046|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|3 months (from Baseline)||||units on a scale||Standard Deviation|Mean
2593657|NCT02243046|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Baseline||||units on a scale||Standard Deviation|Mean
2593658|NCT02243046|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 months (from Baseline)||||units on a scale||Standard Deviation|Mean
2593659|NCT02243046|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|3 months (from Baseline)||||units on a scale||Standard Deviation|Mean
2593660|NCT02243046|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|Baseline||||units on a scale||Standard Deviation|Mean
2593661|NCT02243020|Secondary|Change in Wolf Motor Function Test Functional Assessment (WMFT)|Measurement of upper limb function/mobility. For Functional Assessment - minimum is 0 and maximum is 3. A higher score means a better outcome.|6-weeks||||units on a scale||Standard Deviation|Mean
2593662|NCT02243020|Primary|Change in Upper Extremity Fugl-Meyer (UEFM)|Measurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed.|6-weeks||||units on a scale||Standard Deviation|Mean
2593663|NCT02243007|Secondary|Local Control Rate|The number of participants achieving local control. The local control rate is defined as the number of participants achieving stable disease, partial response, or a complete response.|2 Years|Data not available. Study was terminated before endpoint was able to be evaluated||||||
2593664|NCT02243007|Secondary|Rate of Pathologic Downstaging|The number of participants achieving a reduction in the pathological staging of the primary cancer.|2 Years|Data not available. Study was terminated before endpoint was able to be evaluated||||||
2593665|NCT02243007|Secondary|Correlation of Biomarkers With PFS|Analysis of the correlation between selected bio-markers and progression free survival.|2 Years|Data not available. Study was terminated before endpoint was able to be evaluated||||||
2593666|NCT02243007|Secondary|30-day Post-operative Mortality Rate|Number of patients who died following surgery.|30 Days|Study ended prematurely, no results available||||||
2593667|NCT02243007|Secondary|Surgical Morbidity Rate|Number of patients experiencing a specific surgery related morbidity|within 30 days of surgery|Study ended prematurely, no results available||||||
2593668|NCT02243007|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Number of Participants with Serious and Non-Serious Adverse Events from baseline to 28 days|Baseline, 28 Days||||participants|||Number
2593669|NCT02243007|Secondary|Overall Survival Rate|Overall survival rate at five years using Kaplan-Meier survival analysis|Baseline, 5 Years|Study terminated before endpoint was reached, no data available||||||
2593670|NCT02243007|Secondary|Pathologic Complete Response Rate (pCR).|Number of patients achieving pathologic complete response at 18 months. Pathologic complete response is defined as the absence of residual invasive disease in the panaceas and in the regional lymph nodes.|18 Months|No Data available. Study terminated before any patients reached 18 months of follow-up. Patients were not able to be evaluated for response.||||||
2593671|NCT02243007|Primary|Survival Rate at 18 Month|Number of participants surviving after 18 months of study follow-up|18 Month||||Participants|||Count of Participants
2593672|NCT02242994|Secondary|Error Rate of Communication|Amount of typing errors per sentence|At time of experiment||||errors||Standard Deviation|Mean
2593673|NCT02242994|Primary|Speed of Communication|Measure time (in minutes) to type 3 pre-set sentences|Immediately||||minutes||Standard Error|Mean
2593674|NCT02242942|Secondary|Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D-3L)|The EQ-5D-3L questionnaire is a generic, preference based health utility measure that assesses 5 health states (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and is used to build a composite of the patient's health status. The EQ-5D-3L was employed in this study to calculate health utilities for economic modeling, which ranged 0-1. The EQ-5D-3L also contained a visual analog scale (VAS) to assess the participant's overall health, which ranged from 0-100 with a higher score indicating a worse health status.|Baseline up to approximately 5.75 years||2021-09-30|09/2021||||
2593688|NCT02242942|Secondary|Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Combination Treatment Assessment|MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in bone marrow.|Day 1 Cycle 9 or 3 months after last IV infusion at approximately 9 months|ITT population was defined as all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2593787|NCT02241512|Secondary|Post-ERCP Bleeding|Number of patients who develop post-ERCP bleeding|2 weeks||||Participants|||Count of Participants
2593675|NCT02242942|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQC30)|"The EORTC QLQ-C30 is a validated and reliable self-report measure consisting of 30 questions incorporated into five functional scales (physical, role, cognitive, emotional, and social scales), three symptom scales (fatigue, pain, nausea, and vomiting scales), and a global health status/global quality−of−life scale. The remaining single items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) assess the additional symptoms experienced by patients with cancer and the perceived financial burden of treatment. The 28 function and symptom items were scored on a 4-point scale that ranged from not at all to very much, and the 2 global health status/global quality-of-life items were scored on a 7-point scale that ranged from very poor to excellent. Raw average scale scores were linearly transformed to range 0-100 with higher scores indicating higher response levels (i.e., higher functioning, higher symptom severity)."|Baseline up to approximately 5.75 years||2021-09-30|09/2021||||
2593676|NCT02242942|Secondary|Change From Baseline in M.D. Anderson Symptom Inventory-CLL (MDASI-CLL) Score|"The MDASI-CLL is a questionnaire of 25 items related to CLL specific symptoms that a participant may have experienced in the past 24 hours. Participants were asked to rate the severity of 13 symptoms called mean core symptom severity (i.e., pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, and numbness or tingling), 6 disease-specific symptoms called mean module symptom severity (night sweats, fevers and chills, lymph node swelling, diarrhea, easy bruising or bleeding, and constipation) and 6 mean interference on life questions (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) on a scale from 0 to 10 with 0 indicating that the symptom is not present or did not interfere with the participant's activities and 10 indicating as bad as you can imagine or interfered completely. Scores were averaged (range 0 to 10) for each of three parts."|Baseline up to approximately 5.75 years||2021-09-30|09/2021||||
2593677|NCT02242942|Secondary|Serum Concentrations of Obinutuzumab||Pre-obinutuzumab infusion (0 hour) and end of obinutuzumab infusion on Day 1 Cycle 4|Analysis population consisted of subjects from whom one or more serum samples were collected and who had received at least one dose of obinutuzumab and one dose of 400 mg venetoclax. Pre-dose and post-dose data may not come from the same participants. Total number analyzed is therefore higher than the number analyzed for each time point.|||μg/mL||Standard Deviation|Mean
2593678|NCT02242942|Secondary|Plasma Concentrations of Venetoclax||Pre-venetoclax dose (0 hour) and 4 hours post- venetoclax dose on Day 1 Cycle 4|Analysis population consisted of subjects from whom one or more plasma samples were collected and who had received at least one 400 mg dose of venetoclax. Pre-dose and post-dose data may not come from the same participants. Total number analyzed is therefore higher than the number analyzed for each time point.|||μg/mL||Standard Deviation|Mean
2593679|NCT02242942|Secondary|Percentage of Participants Recorded as Premature Study Withdrawals||Up to approximately 5.75 years||2021-09-30|09/2021||||
2593680|NCT02242942|Secondary|Percentage of Participants With Human-Anti-Human Antibodies||Baseline up to approximately 5.75 years||2021-09-30|09/2021||||
2593681|NCT02242942|Secondary|Percentage of Participants With CD19 + /CD5+ B Cells or CD14+ Monocytes||Baseline up to approximately 5.75 years||2021-09-30|09/2021||||
2593682|NCT02242942|Secondary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs.|Up to approximately 5.75 years||2021-09-30|09/2021||||
2593683|NCT02242942|Secondary|Time to Next Anti-Leukemic Treatment||Time between the date of randomization and the date of first intake of new anti-leukemic therapy, up to 5.75 years||2021-09-30|09/2021||||
2593684|NCT02242942|Secondary|Event-Free Survival||Time between date of randomization and the date of disease progression/relapse on the basis of investigator-assessment, death, or start of a new anti-leukemic therapy, up to 5.75 years||2021-09-30|09/2021||||
2593685|NCT02242942|Secondary|Percentage of Participants By Best Response Achieved (CR, CRi, PR, Stable Disease (SD), or PD)|CR: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: any two for at least 2 months: >/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L. PD: lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia. SD: a non-response and used to characterize participants who did not achieve a CR or a PR, and who have not exhibited PD.|Baseline up to the completion of treatment assessment 3 months after treatment completion (up to approximately 15 months)|ITT population was defined as all randomized participants.|||percentage of participants|||Number
2593686|NCT02242942|Secondary|Duration of Objective Response (DOR)|PD was defined as lymphadenopathy, >=50% increase in liver or spleen size, >=50% increase in lymphocyte count, transformation to a more aggressive histology or occurrence of cytopenia.|Time from the first occurrence of a documented objective response to the time of PD as determined by the investigator or death from any cause, up to approximately 5.75 years||2021-09-30|09/2021||||
2593687|NCT02242942|Secondary|Percentage of Participants With OR at Completion of Combination Treatment Response Assessment|OR was defined as CR, CRi or PR according to IWCLL 2008 criteria. CR required all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L. PR: two of the following features for at least 2 months: >/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L.|Day 1 Cycle 7 or 28 days after last IV infusion, approximately 6 months|ITT population was defined as all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2593689|NCT02242942|Secondary|Percentage of Participants With MRD Negativity in Peripheral Blood as Measured by ASO-PCR at Completion of Combination Treatment Assessment|MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in peripheral blood.|Day 1 Cycle 9 or 3 months after last IV infusion, approximately 9 months|ITT population was defined as all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2593690|NCT02242942|Secondary|Overall Survival (OS)|OS was defined as the time between the date of randomization and the date of death due to any cause.|Baseline until death, up to approximately 5.75 years||2021-09-30|09/2021||||
2593691|NCT02242942|Secondary|Percentage of Participants With MRD Negativity in Bone Marrow as Measured by ASO-PCR at Completion of Treatment|MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in bone marrow.|At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)|ITT population was defined as all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2593692|NCT02242942|Secondary|Percentage of Participants With Minimal Residual Disease (MRD) Negativity in Peripheral Blood as Measured by Allele-Specific Oligonucleotide Polymerase Chain Reaction (ASO-PCR) at Completion of Treatment|MRD negativity was defined as having < 1 CLL cell per 10,000 leucocytes in peripheral blood.|At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)|ITT population was defined as all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2593693|NCT02242942|Secondary|Percentage of Participants With a Complete Response Rate (CRR) at the Completion of Treatment Assessment as Determined by the Investigator According to IWCLL Criteria|CRR was defined as the rate of a clinical response of CR or CRi according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and CT scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri).|At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)|ITT population was defined as all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2593694|NCT02242942|Secondary|Percentage of Participants With an Overall Response (OR) at Completion of Treatment, as Determined by the Investigator According to IWCLL Criteria|OR was defined as complete response (CR), CR with incomplete bone marrow recovery (CRi), or partial response (PR) according to IWCLL 2008 criteria. CR requires all of the following: peripheral blood lymphocytes below 4x10^9/L, absence of lymphadenopathy by physical examination and computed tomography (CT) scan, no hepatomegaly or splenomegaly, absence of disease or constitutional symptoms, blood counts of neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L, bone marrow at least normocellular for age without clonal infiltrate (except for Cri). PR: two of the following features for at least 2 months: >/= 50% decrease in peripheral blood lymphocyte count from the pretreatment value, >/=50% reduction in lymphadenopathy, >/=50% reduction of liver and/or spleen enlargement, and at least one of the following blood counts: neutrophils >1.5*10^9/L, platelets >100*10^9/L and hemoglobin >110 g/L.|At the completion of treatment assessment 3 months after treatment completion (at approximately 15 months)|ITT population was defined as all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2593695|NCT02242942|Primary|Progression Free Survival (PFS) Based on Investigator Assessment According to IWCLL Criteria|PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of PD or death from any cause. Disease progression was characterized by at least one of the following: 1) >/= 50% increase in the absolute number of circulating lymphocytes to at least 5*10^9/L, 2) Appearance of new palpable lymph nodes (> 15 mm in longest diameter) or any new extra-nodal lesion; 3) >/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) >/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.|Baseline until disease progression or death up to approximately 3.75 years|ITT population was defined as all randomized participants.|||months||95% Confidence Interval|Median
2593696|NCT02242942|Secondary|Progression Free Survival (PFS) Based on Institutional Review Committee (IRC)-Assessments According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Criteria|PFS was determined according to IWCLL 2008 criteria and defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause. Disease progression was characterized by at least one of the following: 1) >/= 50% increase in the absolute number of circulating lymphocytes to at least 5*10^9/L, 2) Appearance of new palpable lymph nodes (> 15 mm in longest diameter) or any new extra-nodal lesion; 3) >/= 50% increase in the longest diameter of any previous site of lymphadenopathy; 4) >/= 50% increase in the enlargement of the liver and/or spleen; 5) Transformation to a more aggressive histology.|Baseline until disease progression or death up to approximately 3.75 years|Intent-to-Treat (ITT) population was defined as all randomized participants.|||months||95% Confidence Interval|Median
2593697|NCT02242903|Secondary|PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514||SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85|All randomized participants who received at least 1 dose of investigational drug and had evaluable AUC PK data. Cohort 1 had zero participants analyzed and was not included in summary statistics.|||nanogram•hour/milliliter (ng•h/mL)||Geometric Coefficient of Variation|Geometric Mean
2593698|NCT02242903|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514||SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85|All randomized participants who received at least 1 dose of study drug and had evaluable Cmax PK data.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2593699|NCT02242903|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of SAEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline to Study Completion (Up to 12 Weeks)|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2593700|NCT02242643|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0 -180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.|||Subjects|||Number
2593701|NCT02242643|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination.|During a 28-day (Days 0-27 for primed and unprimed subjects and Days 28-56 for unprimed subjects) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.|||Subjects|||Number
2593702|NCT02242643|Secondary|Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0 -180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.|||Subjects|||Number
2593703|NCT02242643|Secondary|Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed).|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).|During the entire study period (Days 0 -180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.|||Subjects|||Number
2593704|NCT02242643|Secondary|Number of Subjects Reporting Any Fever Following Each Dose and Across Doses.|"Any Fever = all subjects with a documented temperature of ≥38.0°C /100.4°F by axillary route and all subjects reporting temperature < 38.0°C but with missing values for at least one day during the solicited period.~Grade 3 fever was defined as temperature greater than (>) 39.0°C."|During a 2-day (Days 0-1) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.|||Subjects|||Number
2593705|NCT02242643|Secondary|Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|Duration was defined as number of days with any grade of local and general symptoms.|During the 7-day (Days 0-6) follow-up period after each vaccination.|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.|||Days||Full Range|Median
2593706|NCT02242643|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>) 39.0°C.|During the 7-day (Days 0-6) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.|||Subjects|||Number
2593707|NCT02242643|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity and all subjects reporting 'Yes' for solicited symptom occurred but with missing values for at least one day during the solicited period. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During a 7-day (Day 0 - Day 6) follow-up period after each vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.|||Subjects|||Number
2593777|NCT02241551|Secondary|Quality of Life Effects of Chemotherapy on Patients Receiving Chemotherapy and SBRT|This will be measured using the FACT-HB questionaire|Up to 5 years|Patient did not receive three cycles of treatment - data not collected.||||||
2593778|NCT02241551|Secondary|Radiological Response Rate to Therapy|Radiological improvements will be evaluated by determining changes in density of measurable disease on CT scan pre and post chemotherapy|Up to 5 years|Patient did not receive three cycles of treatment - data not collected.||||||
2593708|NCT02242643|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).|28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The ATP cohort for immunogenicity included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2593709|NCT02242643|Secondary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).|28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Subjects|||Number
2593710|NCT02242643|Secondary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).|At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The ATP cohort for immunogenicity included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Subjects|||Number
2593711|NCT02242643|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).|At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Titers||95% Confidence Interval|Mean
2593712|NCT02242643|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.|HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).|At 28 days after the last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2593713|NCT02242643|Primary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains|"Antibody titers were expressed as Seroconversion rate (SCR) and SCR difference. SCR was defined as the proportion of vaccinees who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.~The vaccine strains assessed were Flu A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria)."|28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Subjects|||Number
2593714|NCT02242630|Other Pre-specified|Safety|Safety of either methylprednisolone or triamcinolone, either related to the medication received or the dose received.|6 weeks|||||||
2593715|NCT02242630|Secondary|Change in Subject Reported Shoulder Pain as Measured by the Visual Analogue Scale|Change in shoulder pain reported by the subject after injection at 6 weeks. The subject will report shoulder pain on a scale from 0 (no pain) to 10 (maximal pain) after injection. A 2 point change is expected.|6 weeks||||units on a scale||95% Confidence Interval|Mean
2593716|NCT02242630|Primary|Change in Shoulder Function, as Measured by the QuickDASH ®|The primary outcome of this study will be to compare the dose and type of intrabursal corticosteroid received to improvements in a functional measure of the shoulder, the QuickDASH. The QuickDASH is a validated questionnaire of shoulder function consisting of 11 questions with a score from 100 (maximal dysfunction) to 0 (no dysfunction). It is expected that improvements will lead to at least a 10 point improvement (minimal clinically important difference)|6 weeks||||units on a scale||95% Confidence Interval|Mean
2593779|NCT02241551|Secondary|Measurement of Biomarkers (SPARC, RM1 and SMAD4) in Tissues|This wil be measured in tissues that are obtained at screening and in the resected tumour specimen|Up to 5 years|Patient did not receive three cycles of treatment - data not collected.||||||
2593780|NCT02241551|Secondary|Time to Disease Progression||Up to 5 years|Patient did not receive three cycles of treatment - data not collected.||||||
2593717|NCT02242487|Secondary|Change From Baseline in OFF Time.|"Patient reported total daily OFF time and was assessed by the patient and recorded in the patient Diary. An OFF state is defined as the time when medication is not providing benefit with respect to mobility, slowness, and stiffness. OFF episodes may be heralded by non-motor symptoms (e.g., pain, anxiety) prior to the appearance of motor symptoms. Patients will record their ON and OFF states in their diaries at home."|Change from baseline through 12 months duration of outpatient use|ITT - (Intent-to-Treat) Population. Patients who discontinue the study prior to a treatment visit are not included in the analysis for that treatment visit. Therefore, the number of patients decreases with each successive treatment visit.|||Hours||Standard Error|Least Squares Mean
2593718|NCT02242487|Secondary|Count of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.|Count of patients achieving resolution of an OFF to an ON state within 60 minutes after study drug is administered in the clinic, and maintaining the ON state at 60 minutes after study drug administration (per the examiner's subjective assessment).|At Treatment Visit - TV6 (Week 52)|ITT (Intent-to-Treat) Population|||Participants|||Count of Participants
2593719|NCT02242487|Primary|Pulmonary Safety for CVT-301 Change From Baseline for (FEV1/FVC).|To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FEV1/FVC (FEV1-forced expiratory volume in 1 second and (FVC) forced vital capacity ratio) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD (Parkinson's Disease) patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.|Change from baseline at 52 weeks|Safety Population - Safety population - Altogether, 325 patients were randomized and 312 patients received at least 1 dose of study drug and were included in the Safety Population. Thirteen patients were randomized but did not receive study drug.|||Ratio %||Standard Deviation|Mean
2593720|NCT02242487|Primary|Pulmonary Safety for CVT-301 Change From Baseline for FVC.|To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FVC, (forced vital capacity) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.|Change from baseline at 52 weeks|Safety Population - Safety population - Altogether, 325 patients were randomized and 312 patients received at least 1 dose of study drug and were included in the Safety Population. Thirteen patients were randomized but did not receive study drug.|||Liter||Standard Deviation|Mean
2593721|NCT02242487|Primary|Pulmonary Safety of CVT-301 Change From Baseline for FEV1.|To characterize the effects of CVT-301 on pulmonary safety, as assessed by spirometry FEV1 (forced expiratory volume in 1 second) by treatment group and Treatment Visit (TV). This study was a 12-month, dose-level blinded, multi-center study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF periods per day in PD (Parkinson's Disease) patients experiencing motor fluctuations (OFF periods). Baseline is defined as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004 study and as the last non-missing assessment before the first dose of CVT-301 in CVT-301-004E study for the rest of the patients.|Change from baseline at 52 weeks|Safety population - Altogether, 325 patients were randomized and 312 patients received at least 1 dose of study drug and were included in the Safety Population. Thirteen patients were randomized but did not receive study drug.|||Liters||Standard Deviation|Mean
2593722|NCT02242305|Secondary|Percentage of Event for Time to Therapeutic Effect|This outcome measure presents percentage of event for time to therapeutic effect defined as the time that the first VAS reduction occurred.|From time of the first dose to the time that the first VAS reduction occurred, up to 180 minutes after the first dose on Day 1.|Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.|||Percentage of event|||Number
2593723|NCT02242305|Secondary|Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination|Number of patients with findings in clinical relevant abnormalities for laboratory, vital signs, ElectroCardioGram (ECG) and physical examination. Relevant findings or worsening of baseline conditions were reported as Adverse Events (AEs).|Up to 3 days.|Safety Set (SFS): All randomized subjects who took at least one dose of study medication.|||Participants|||Number
2593724|NCT02242305|Secondary|Global Assessment of Tolerability by Investigator on a 4-point Scale|The endpoint presents global assessment of tolerability by subject on a 4-point scale. Global assessment of tolerability regarding all episodes treated by the subject after 3 days of treatment (good, satisfactory, not satisfactory, bad).|Day 3.|Safety Set (SFS): All randomized subjects who took at least one dose of study medication.|||Participants|||Number
2593725|NCT02242305|Secondary|Number of Patients With Adverse Events|The endpoint presents number of patients with Adverse Events (AEs). Subjects were required to report spontaneously any AEs as well as the time of onset, end and intensity of these events. Specific questions were asked wherever required or useful to more precisely describe an AE. An Adverse Event was termed serious when one of the following applied: death, directly lifethreatening, continuous or severe impairment, in-patient treatment or prolonging of hospitalization, congenital deformity and other similar medical criteria.|Up to 3 days.|Safety Set (SFS): All randomized subjects who took at least one dose of study medication.|||Participants|||Number
2593726|NCT02242305|Secondary|Global Assessment of Efficacy by Patient on 4-point Scale|The endpoint presents global assessment of efficacy: by the patient after 3 days of treatment using a 4-point rating scale (good, satisfactory, not satisfactory, and bad).|Post 3 days of treatment.|Full Analysis Set (FAS): According to the Intent-to-Treat (ITT) principle, all randomized subjects who took at least one dose of study medication and who provided any data for the primary efficacy endpoint were used in FAS.|||Participants|||Number
2593781|NCT02241551|Secondary|Ca19-9 Response to Neoadjuvant Chemotherapy||Up to 5 years|Patient did not receive three cycles of treatment - data were not collected / zero total participants were analyzed.||||||
2593727|NCT02242305|Secondary|Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS)|"The endpoint presents frequency improvement, change of the pain frequency from baseline pain frequency for each of Day 1 - 3. Baseline pain frequency meant the pain frequency before randomization on visit 1. VRS score of Day 3 change from baseline was calculated. A retrospective assessment was entered by the patient in the patient diary, again once daily in the evening, of the pain frequency over the preceding 24 hour period. This was based on a 4-stage Verbal Rating Scale (VRS) with the following scores to the question: How many times have the spasm-like pains occurred today? 0 = not at all, 1 = 1-2 times, 2 = 3-5 times, 3 = more than 5 times."|Up to 3 days.|Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.|||Units on a scale||Standard Deviation|Mean
2593728|NCT02242305|Primary|Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA|"The endpoint presents change of the mean Visual Analogue Scale (VAS) of pain intensity score, recorded daily by the patient in the evening in his/her patient diary describing pain intensity during the previous 24 hours, from the baseline pain intensity. The baseline pain intensity was the pain intensity of first episode on Day 1 after randomization before taking study medication. The mean VAS pain intensity score was calculated for the 3-day treatment period. A VAS for describing the pain intensity was used (VAS: maximum score of 10 cm, the score from 0 - 10 cm reaching from no pain to the most severe pain imaginable)."|3 days (1 day)|Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.|||Units on a scale|||Number
2593729|NCT02242201|Other Pre-specified|Number of Participants Reporting a NRS Pain Score Greater Than 3|Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.|3 month follow up|Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.|||Participants|||Count of Participants
2593730|NCT02242201|Other Pre-specified|Number of Participants Reporting Complications Since Surgery|Complications were collected by telephone interview after surgery.|Post-operative Day 1 Through 3 - Month Follow-up|Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.|||Participants|||Count of Participants
2593731|NCT02242201|Other Pre-specified|Change in Short Form-36 (SF-36) Quality of Life Mental Component|Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).|Baseline, 3 months|Data were available for 50, 52, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.|||units on a scale||Standard Deviation|Mean
2593732|NCT02242201|Other Pre-specified|Change in Short Form-36 (SF-36) Quality of Life Physical Component|Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).|Baseline, 3 months|Data were available for 50, 52, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.|||units on a scale||Standard Deviation|Mean
2593733|NCT02242201|Other Pre-specified|Post-Operative Pain Score|Pain intensity (NRS) assessment at 3 month follow-up. Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.|3 month follow-up|Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.|||units on a scale||Inter-Quartile Range|Median
2593734|NCT02242201|Other Pre-specified|Change in Unipedal Stance Time|Length of time in seconds a patient could stand on involved leg|Baseline, 3 months|Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.|||seconds||Inter-Quartile Range|Median
2593735|NCT02242201|Other Pre-specified|Hospital Length of Stay|Discharge readiness was evaluated by the surgical team during morning and afternoon physical therapy sessions.|Post-operative Day 1 through discharge (approximately 3 days)||||days||Inter-Quartile Range|Median
2593736|NCT02242201|Secondary|Total Opioid Consumption During Hospitalization|Measured in daily oral morphine equivalents (OME)|Preoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2|For Post Operative Day (POD) 2, data were missing for 26 subjects (7 in the PNB group, 9 in the PAI-R group, and 10 in the PAI-L group).|||Oral morphine equivalent in milligrams||Inter-Quartile Range|Median
2593737|NCT02242201|Primary|Maximum Postoperative Pain Score|Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.|Post-Operative Day 1 (0600-1200)||||units on a scale||Inter-Quartile Range|Median
2593738|NCT02242019|Primary|Change in Millimeters (mm) of Clear Nail Bed|Millimeter (mm) of clear nail from the base of the toenail was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. An increase in mm of clear nail between the two measurement points indicates that the toenail has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail has worsened and is negative for study success.|Baseline and 36 Weeks|Some subjects had multiple toenails with onychomycosis disease involvement that were treated and analyzed, resulting in a total of 139 study toenails being analyzed.|||millimeters (mm)|Participants|Standard Deviation|Mean
2593782|NCT02241551|Secondary|Incidence of Grade 3 and 4 Toxicities for the 2 Chemotherapy Regimens That Occur After Cycle 1 Day 1|According to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTAE, v4.0)|Up to 5 years|Patient was not treated - no data collected.||||||
2593783|NCT02241551|Secondary|R0 Resection Rates in Borderline Resectable Pancreatic Cancer||Up to 5 years|Patient did not receive three cycles of treatment - data were not collected.||||||
2593739|NCT02242019|Secondary|Change in Percent (%) of Onychomycosis Disease Involvement|The percent (%) of the toenail that had onychomycosis disease involvement was determined. Change in the % of toenail onychomycosis disease involvement was calculated as the difference in the % of toenail onychomycosis disease involvement from baseline measurement to the measurement at 36 weeks after the end of the procedure administration phase. A decrease in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has decreased and is positive for study success. An increase in the % of toenail onychomycosis disease involvement between the two measurement points indicates that the toenail onychomycosis involvement has increased and is negative for study success.|Baseline and 36 Weeks||||percentage of disease involvement|Participants|Standard Deviation|Mean
2593740|NCT02242019|Primary|Number of Toenails Attaining 3 Millimeters (mm) or More of Clear Nail Growth|Individual toenail success criteria was defined as 3 millimeter (mm) or more of clear nail growth at 36 weeks post-procedure administration as evaluated relative to baseline. Overall study success criteria was defined as an 60% or more of treated toenails meeting the individual success criteria.|Baseline and 36 Weeks||||toenails|Participants||Number
2593741|NCT02241889|Secondary|Percent of Time of CBG>180 mg/dl|Assess the percent of time that the Contour Next BG meter reported blood glucose values greater than 180 mg/dl using meter downloads.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||percentage of time||95% Confidence Interval|Mean
2593742|NCT02241889|Secondary|Number of Events With CBG <50 mg/dl|Assess the total number of events that the Contour Next BG meter reported blood glucose values less than 50 mg/dl across all participants in each group.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||occurrences of blood glucose < 50 mg/dl|||Number
2593743|NCT02241889|Secondary|Number of Events With CBG Between 70 - 180 mg/dl|Assess the number of events that the Contour Next BG meter reported blood glucose values between 70-180 mg/dl using meter downloads.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||# of events||95% Confidence Interval|Mean
2593744|NCT02241889|Secondary|Number of Events Capillary Blood Glucose (CBG) <70 mg/dl|Number of events measured with capillary blood glucose <70 mg/dl.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||occurrences of blood glucose < 70 mg/dl||95% Confidence Interval|Mean
2593745|NCT02241889|Secondary|Percent of Time With Sensed Glucose > 180 mg/dl|Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values greater than 180 mg/dl using Dexcom sensor downloads.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||percent of time||95% Confidence Interval|Mean
2593746|NCT02241889|Secondary|Percent of Time With Sensed Glucose < 50 mg/dl|Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values less than 50 mg/dl using Dexcom sensor downloads.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||percent of time||95% Confidence Interval|Mean
2593747|NCT02241889|Secondary|Number of Carbohydrate Treatments|Assess the number of rescue carbohydrate treatments.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||carbohydrate treatments||95% Confidence Interval|Mean
2593748|NCT02241889|Secondary|Mean of the Mean Sensed Glucose Per Participant|Assess the mean sensed glucose per participant using Dexcom sensor downloads.|Entire 21 hour study duration excluding the first four hours|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||mg/dl||95% Confidence Interval|Mean
2593749|NCT02241889|Primary|Percent of Time With Sensed Glucose Between 70-180 mg/dl|Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values between 70-180 mg/dl using Dexcom sensor downloads.|from start of exercise (~hour 12) until study completion (hour 21)|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||percent of time||95% Confidence Interval|Mean
2593750|NCT02241889|Primary|Percent of Time With Sensed Glucose < 70 mg/dl|Assess the percent of time that the Dexcom G4 or G4 Share reported sensor glucose values less than 70 mg/dl using Dexcom sensor downloads.|from start of exercise (~hour 12) until study completion (hour 21)|Data was analyzed from 21 subjects that completed all 3 visits and visits went to completion. No data was analyzed from the two subjects that did not complete all visits.|||percentage of time||95% Confidence Interval|Mean
2593751|NCT02241785|Secondary|Change in MSIS-29 Physical Impact Scores From Baseline (Day -1) to Reset Baseline (Week 8)|The MSIS-29 is a brief self-administered MS-specific instrument measuring physical (20 items) and mental/psychological (9 items) impact of MS. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health.|Baseline (Day -1) to Reset Baseline (Week 8)|Intent-to-treat population: participants who received at least 1 infusion of study treatment and had an assessment.|||units on a scale||Standard Deviation|Mean
2593752|NCT02241785|Secondary|Pre- and Post-Natalizumab Infusion Annualized Relapse Rate (ARR) Comparison at Month 12|An MS relapse was defined as the onset of new or recurrent neurological symptoms lasting at least 24 hours, accompanied by new objective abnormalities on a neurological examination, and not explained solely by non-MS processes such as fever, infection, severe stress, or drug toxicity. 95% confidence interval is based on a Poisson regression model.|From 12 months prior to natalizumab infusion and 12 months post-natalizumab infusion|Intent-to-treat population: participants who received at least 1 infusion of study treatment and had an assessment.|||relapses per subject-year||95% Confidence Interval|Number
2593753|NCT02241785|Secondary|Proportion of Participants With NEDA From Week 8 (Reset Baseline) to Week 104|Proportion of participants with NEDA from Week 8 (Reset Baseline) to Week 104 (with no 12-week confirmed EDSS progression determined at Week 116). NEDA was defined as follows: no EDSS progression (12-week sustained); no relapses; no Gd+ lesions; no new or enlarging T2 hyperintense lesions over 48 weeks after resetting the Baseline at Week 8 to remove contribution of CUA lesions that occurred prior to Week 8, when natalizumab was not yet active. The EDSS quantifies disability in 8 functional systems. The final EDSS score is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.|from Week 8 (Reset Baseline) to Week 104|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2593754|NCT02241785|Secondary|Change in T1 Unenhancing Lesion Volume and T2 Lesion Volume From Baseline (Day -1) to Reset Baseline (Week 8)|As measured by magnetic resonance imaging.|Baseline (Day -1) to Reset Baseline (Week 8)|Intent-to-treat population: participants who received at least 1 infusion of study treatment and had an assessment.|||cc||Standard Deviation|Mean
2593755|NCT02241785|Primary|Proportion of Participants With No Evidence of Disease Activity (NEDA) From Reset Baseline (Week 8) to Week 56|The proportion of participants with NEDA, defined as follows: no Expanded Disability Status Scale (EDSS) progression (12-week sustained); no relapses; no gadolinium enhancing (Gd+) lesions; no new or enlarging T2 hyperintense lesions over 48 weeks after resetting the Baseline at Week 8 to remove contribution of combined unique active (CUA) lesions that occurred prior to Week 8, when natalizumab was not yet active. The EDSS quantifies disability in 8 functional systems. The final EDSS score is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.|Reset Baseline (Week 8) to Week 56|The limited number of participants enrolled and the early termination of the study resulted in efficacy data not collected, and efficacy outcomes not analyzed, as per the pre-specified plan of analysis.||||||
2593756|NCT02241733|Secondary|Mastery Over Breathing|"Mastery over breathing is measured using the Chronic Respiratory Disease Questionnaire. Specifically the subscale 'mastery is the investigators' secondary outcome. The difference in scores from baseline to 52 weeks is the investigators' outcome measure. The Chronic Respiratory Disease Questionnaire is a valid and reliable questionnaire. 1=minimum score, 7=maximum with the higher score indicating greater mastery. A higher score indicates better health. A change of 0.5 indicates a small change, 1.0 indicates a moderate change and greater or equal to a change of 1.5 indicates a large change."|52 weeks|Multiple imputation was used to impute missing values for those who did not complete the protocol.|||score on a scale||Standard Deviation|Mean
2593757|NCT02241733|Secondary|6 Minute Walk Distance|Six-minute walk distance will be measured at 52 weeks. The difference in distance walked in meters between baseline and 52 weeks is the secondary outcome measure. The 6 minute walk is conducted using the guidelines issued by the American Thoracic Society.|52 weeks|Multiple imputation procedures were used to impute data for those that did not complete the protocol|||meters||Standard Deviation|Mean
2593758|NCT02241733|Secondary|Inspiratory Capacity|Inspiratory capacity is measured at a set time during the constant workrate treadmill test. The difference between the inspiratory capacity measured at baseline and 52 weeks is a secondary outcome. Inspiratory capacity measured during exercise is a measure of dynamic hyperinflation.|52 week test|A multiple imputation model was used to impute values for those who did not complete the program. The score below is the difference between 52 weeks and baseline.|||difference in liters inspired||Standard Deviation|Mean
2593759|NCT02241733|Primary|Duration of Exercise Time on a Constant Work-rate Treadmill Test|Patients walk on a treadmill set at a constant workrate. The difference in the time walked on the treadmill from baseline to study completion is the primary outcome measure.|52 week test|A multiple imputation model was used to impute missing values for those who did not complete the 52 weeks of the program.|||change in number of minutes walked||Standard Deviation|Mean
2593760|NCT02241720|Primary|Number of Participants With Stable Disease at Eight Weeks Post-Treatment|Patients had disease assessed by CT scans. Stable Disease is defined by any response better than Progression as defined by RECIST 1.1. Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|5 months - 3 months treatment and 8 weeks post end of treatment visit|3 subjects did not complete an 8 week EOT visit for: Death, Patient W/D, AE.|||Participants|||Count of Participants
2593761|NCT02241655|Other Pre-specified|Postoperative Actigraphy- Immobile Minutes|Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. We quantified inactivity using the number of immobile minutes, defined as the total number of minutes with an RMSactivity count of zero- higher number indicates patient had more time being immobile.|1 day|A total of 84 patients had analyzable data and included in the analysis. Patients were pooled regardless of intervention (EEG guidance or usual care) since the primary outcome was to assess whether using actigraphy could predict delirium regardless of interventions. Therefore, patients were separated by delirious and non-delirious patients.|||minutes RMSactivity=0||Inter-Quartile Range|Median
2593762|NCT02241655|Other Pre-specified|EEG and Delirium|EEG abnormalities have previously been associated with postoperative delirium|5 days||2020-07-31|07/2020||||
2593763|NCT02241655|Other Pre-specified|Number of Participants With Severe Delirium|The severity of delirium will be scored using the CAM-Severity (CAM-S) metric, which has specifically been shown to be strongly associated with clinically relevant outcomes. Severe delirium was defined as patients with a CAM-S score of 10 or greater (range 0-19).|5 days|A total of 1232 patients were randomized (614 EEG guided protocol and 618 control arm). In the EEG guided group 10 patients could not be assessed for delirium (6 comatose, 2 withdrew, 2 early hospital discharge). In the control arm 9 patients could not be assessed for delirium (1 died, 5 comatose, 1 withdrew, 2 early hospital discharge).|||Participants|||Count of Participants
2593784|NCT02241551|Primary|Safety and Efficacy Using Neo-adjuvant Gemcitabine Plus Nab-paclitaxel in Patients Receiving SBRT and Surgery for Borderline Resectable Pancreatic Cancer, Using Neo-adjuvant mFOLFIRINOX as a Control|Efficacy: pathological complete response (pCR) and R0 resection. Safety: Grade 4 toxicity.|up to 5 years|Patient did not receive three cycles of treatment - data were not collected.||||||
2593764|NCT02241655|Other Pre-specified|Collaborations With Other Studies|The ENGAGES study is being conducted in collaboration with complementary trials at the University of California, San Francisco (UCSF) (NCT01983384), the University of Michigan in Ann Arbor and the University of Manitoba in Winnipeg. Some of the outcomes will be analyzed considering data from some or all of these studies, as appropriate. In terms of the practicality of disseminating the EEG-guided protocol in North America and beyond, it will be important to demonstrate the feasibility and impact of the protocol in multiple sites.|5 years||2025-01-31|01/2025||||
2593765|NCT02241655|Other Pre-specified|Delirium Prediction Models|It is important to improve our understanding of factors that are associated with an increased incidence of postoperative delirium or perhaps may even mediate an elevated risk for postoperative delirium. The arm/group was included in the model to determine if it was associated with postoperative delirium therefore data is not presented by arm/group.|5 days|Covariated included were pre-selected and considered likely to be associated with postoperative delirium.|||odds ratio||95% Confidence Interval|Number
2593766|NCT02241655|Other Pre-specified|Postoperative Outcomes Hypothesized to be Associated With Anesthetic Depth|There is an ongoing randomized, clinical trial investigating the effects of depth of anesthesia on a range of outcomes98, including death, myocardial infarction, cardiac arrest, pulmonary embolus, stroke, surgical site infection, ICU length of stay, hospital length of stay, intraoperative awareness, persistent pain and cancer recurrence. Many of these outcomes are tracked with the SATISFY-SOS study, and will therefore be reported for patients enrolled in the ENGAGES study.|1 year||2020-12-31|12/2020||||
2593767|NCT02241655|Other Pre-specified|Relationship Between Clinical CAM-ICU and Rigorous Delirium Assessments|Routine clinical (i.e. conducted by ICU nursing staff) delirium assessments in the intensive care units (conducted with the CAM-ICU) will be collected when these are available. Comparison will be made on the outcome of the assessment (positive for delirium or negative by delirium) between these routine clinical assessments and the assessments made by the research team. Since the purpose of this is to determine whether clinical staff are picking up episodes of delirium compared to researcher's assessment in all patients regardless of treatment group, data from both treatment arms were combined for the analysis.|5 days|Patients who were in the ICU, had a nursing CAM-ICU assessment and researcher's delirium assessment were included in this analysis. Agreement between the instruments was calculated using Kappa agreement.|||Cohen's kappa coefficient||95% Confidence Interval|Number
2593768|NCT02241655|Other Pre-specified|Postoperative Actigraphy|Postoperative disturbances in sleep abnormalities have previously been associated with postoperative delirium. Measures of root mean-squared activity (RMSactivity) was calculated by combining counts (binned in 1-minute intervals) across all three accelerometer axes (X, Y, and Z) from 16:00 on the day of surgery to 6:00 the following day. Median activity count was calculated from all minutes with nonzero RMS activity within each epoch- higher values indicate more movement.|1 day|A total of 84 patients had analyzable data and included in the analysis. Patients were pooled regardless of intervention (EEG guidance or usual care) since the primary outcome was to assess whether using actigraphy could predict delirium regardless of interventions. Therefore, patients were separated by delirious and non-delirious patients.|||minutes RMSactivity>0||Inter-Quartile Range|Median
2593769|NCT02241655|Other Pre-specified|Comparison of Patient-reported and Observational Pain Scores|Given that postoperative delirium is common and may relate to uncontrolled pain, this has important implications for the assessment and treatment of postoperative pain. We plan to compare patient reported and behavioral pain assessments in both non-delirious and delirious patients.|5 days||2020-07-31|07/2020||||
2593770|NCT02241655|Other Pre-specified|Clinically Relevant Outcomes Associated With Delirium|Delirium incidence, duration and severity have all been shown to be associated with other (downstream) clinically relevant outcomes, including mortality, length of ICU stay, length of hospital stay, falls, cognitive decline and functional decline.|1 year||2020-12-31|12/2020||||
2593771|NCT02241655|Other Pre-specified|Duration or Recurrence of Delirium After Hospital Discharge|As measured by the FAM-CAM and patient perceptions|30 days post discharge||2020-07-31|07/2020||||
2593772|NCT02241655|Other Pre-specified|Agreements Among the FAM-CAM, Researchers' Delirium Assessments and Patient Perceptions|The Family Confusion Assessment Method (FAM-CAM) instrument has previously been shown to have good agreement with the CAM and with DSM-IV diagnostic criteria in patients with cognitive impairment and in hospitalized patients.|5 days||2020-07-31|07/2020||||
2593773|NCT02241655|Other Pre-specified|Duration of Delirium|Duration will be calculated by the number of positive CAM,CAM-ICU or delirium chart reviews.|5 days|A total of 1232 patients were randomized (614 EEG guided protocol and 618 control arm). In the EEG guided group 10 patients could not be assessed for delirium (6 comatose, 2 withdrew, 2 early hospital discharge). In the control arm 9 patients could not be assessed for delirium (1 died, 5 comatose, 1 withdrew, 2 early hospital discharge).|||days||Inter-Quartile Range|Median
2593774|NCT02241655|Secondary|Health Related Quality of Life|The hypothesis is that the EEG-guided anesthetic protocol will improve postoperative quality of life. Patient self-reported Health-related Quality of Life information will be assessed through the Veteran's RAND 12-item Health Survey at baseline and during follow-up (30-day and 1-year).|Up to one year postoperatively||2020-12-31|12/2020||||
2593775|NCT02241655|Secondary|Postoperative Falls|The hypothesis is that the EEG-guided anesthetic protocol and providing a safety intervention will prevent subsequent injurious falls. Falls will be assessed using the Prevention of Falls Network Europe (ProFaNE) questions. At baseline questions will be asked about preoperative falls, and at 30-days and 1-year postoperatively, questions will be asked about postoperative falls.|Up to 1 year postoperatively||2020-12-31|12/2020||||
2593776|NCT02241655|Primary|Number of Participants With Delirium|Delirium will be assessed at baseline and then once a day postoperative for up to 5 days. Patients were assessed for delirium using the Confusion Assessment Method for verbal patients or the Confusion Assessment Method for the Intensive Care Unit for non verbal or intubated patients, and patients medical records were reviewed for evidence of delirium by doctors and nurses assessments. Patients were considered to have delirium by any modality at anytime postoperative day one through five.|5 days|A total of 1232 patients were randomized (614 EEG guided protocol and 618 control arm). In the EEG guided group 10 patients could not be assessed for delirium (6 comatose, 2 withdrew, 2 early hospital discharge). In the control arm 9 patients could not be assessed for delirium (1 died, 5 comatose, 1 withdrew, 2 early hospital discharge).|||Participants|||Count of Participants
2593788|NCT02241512|Primary|Post-ERCP Pancreatitis|Number of patients who develop post-ERCP pancreatitis|2 weeks||||Participants|||Count of Participants
2593789|NCT02241486|Primary|Pain Relief|Patients suffering from burn injuries will receive sublingual fentanyl spray (Subsys) to address procedural pain (dressing changes/minor debridement). It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury.|60 min|No participants are included in this analysis because the trial was terminated prematurely. As a result, data to assess primary and secondary study aims are incomplete or entirely unavailable for summary or statistical comparisons.||||||
2593790|NCT02241187|Secondary|Safety of Administration of PEGPH20 and Cetuximab|in close proximity to surgical resection of pancreatic adenocarcinoma. Safety with regards to operative and post-operative complications will be characterized.|1 year|The two participants accrued to this study were healthy participants. No participants were accrued on study for treatment. No data were collected.||||||
2593791|NCT02241187|Primary|Effects of PEGPH20|administration on resectable pancreatic adenocarcinoma tumors. DW- and DCE-MRI and distribution of cetuximab will be used to study tumor permeability to small and larger molecules, respectively. Resected tumors will be carefully studied for evidence of stromal degradation.|1 year|The two participants accrued to this study were healthy participants. No participants were accrued on study for treatment. No data were collected.||||||
2593792|NCT02240810|Secondary|Target Vessel Revascularization (TVR)|A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of TVR to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978|Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|The outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure).|||Participants|||Count of Participants
2593793|NCT02240810|Secondary|Myocardial Infarction (MI)|A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of MI to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978|Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|The outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure).|||Participants|||Count of Participants
2593794|NCT02240810|Secondary|Death|A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978|Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|the outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure).|||Participants|||Count of Participants
2593795|NCT02240810|Primary|Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR)|A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death, MI, TVR to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978|Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|the outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure).|||Participants|||Count of Participants
2593796|NCT02240693|Primary|Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment From Two Twin Trials, Present 1289.5 (NCT02240693) and 1289.7 (NCT02337907)|Neuropsychological Test Battery (NTB) response, defined as change from baseline in total z-score after 12 weeks of treatment. The NTB Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean at baseline. Negative numbers indicate values lower than baseline and positive numbers indicate values higher than baseline. Change from baseline will be calculated as the post-baseline composite z-score minus the pre-treatment z-score, such that a positive change indicates an improvement from baseline|Baseline and 12 weeks|FAS observed cases for pooled groups of these twin trials|||z-score||Standard Error|Least Squares Mean
2593797|NCT02240693|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog11) Total Score After 12-week Treatment|Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog11) is an 11-item cognitive subscale that objectively measures memory, language, orientation, and praxis with a total score range of 0 to 70. The greater the dysfunction, the greater the score. Least Squares Mean is actually an adjusted mean change from baseline.|Baseline and 12 weeks|FAS- Observed cases|||Unit on scale||Standard Error|Least Squares Mean
2593798|NCT02240693|Secondary|Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Total Score After 12-week Treatment|"The CDR-SB is obtained through semi-structured interviews of patients and informants, and cognitive functioning was rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care.~Each domain was rated on a 5-point scale of functioning as follows: 0-no impairment; 0.5-questionable impairment; 1-mild impairment; 2-moderate impairment and 3-severe impairment. Only personal care was scored on a 4-point scale without a 0.5 rating available. The higher the score, the greater the severity of dementia. Least Squares Mean is actually an adjusted mean change from baseline."|Baseline and 12 weeks|FAS- Observed cases|||Unit on scale||Standard Error|Least Squares Mean
2594364|NCT02233738|Secondary|Short Inventory of Problems at 1 Month|Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use|1 month||||score on a scale||Standard Deviation|Mean
2593799|NCT02240693|Secondary|Change From Baseline in ADCS-MCI-ADL (Alzheimer's Disease Cooperative Study/Activities of Daily Living for Patients With Mild Cognitive Impairment) Total Score After 12-week Treatment|"Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS-ADL) is a rating scale used to assess basic and instrumental activities of daily living. In the full version of the scale, 23 items are rated by the investigator using information supplied by the caregiver.~Each item has a score range varying from 0-3 to 0-5. The sum score can range from 0 to 78. Higher scores indicate better function.~Least Squares Mean is actually an adjusted mean change from baseline."|Baseline and 12 weeks|FAS- Observed cases|||Unit on scale||Standard Error|Least Squares Mean
2593800|NCT02240693|Primary|Change From Baseline in Neuropsychological Test Battery in Total Z-score After 12-week Treatment.|Neuropsychological Test Battery (NTB) response, defined as change from baseline in total z-score after 12 weeks of treatment. The NTB Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean at baseline. Negative numbers indicate values lower than baseline and positive numbers indicate values higher than baseline. Change from baseline will be calculated as the post-baseline composite z-score minus the pre-treatment z-score, such that a positive change indicates an improvement from baseline|Baseline and 12 weeks|The full analysis set (FAS) included all randomised patients who were treated with at least one dose of trial medication and had a baseline and at least one post-baseline on-treatment efficacy assessment. Observed cases (OC)|||z-score||Standard Error|Least Squares Mean
2593801|NCT02240680|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|This outcome has measured difference between FPG values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication|Baseline and Week 24|Full analysis set observed cases (FAS (OC)): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value. These analyses used available data as observed while patients were on treatment. All values collected after a patient started rescue medication were excluded from the analysis.|||milligram/decilitre||Standard Error|Least Squares Mean
2593802|NCT02240680|Secondary|Percentage of Patients With HbA1c Lowering by at Least 0.5%.|The percentage of patients who attained lowering of HbA1c by ≥0.5% from baseline after 24 weeks of treatment were analysed. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.|24 weeks|Full analysis set non-completers considered failure (FAS (NCF)): Includes all patients randomised in the treated set who had a baseline and at least one on-treatment HbA1c value. This analyses regarded missing values for binary efficacy endpoints as failure.|||Percentage of patients (%)||95% Confidence Interval|Number
2593803|NCT02240680|Secondary|Percentage of Patients With HbA1c on Treatment <7.0%|This is the percentage of patients with HbA1c on treatment <7.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.|24 weeks|Full analysis set non-completers considered failure (FAS (NCF)): Includes all patients randomised in the treated set who had a baseline and at least one on-treatment HbA1c value. This analyses regarded missing values for binary efficacy endpoints as failure.|||Percentage of Patients (%)||95% Confidence Interval|Number
2593804|NCT02240680|Secondary|Percentage of Patients With HbA1c<8.0%|This is the percentage of patients with HbA1c on treatment <8.0% after 24 weeks of treatment. The confidence intervals mentioned in measure of dispersion are exact 95% CI by Clopper and Pearson.|24 weeks|Full analysis set (Non-completers considered failure)(FAS (NCF)): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value. This analyses regarded missing values for binary efficacy endpoints as failure.|||Percentage of patients (%)||95% Confidence Interval|Number
2593805|NCT02240680|Secondary|Percentage of Patients Experiencing at Least One Hypoglycaemia Accompanied by a Prespecified Glucose Value.|Hypoglycaemia accompanied by a prespecified glucose value is defined as any investigator reported hypoglycaemia (event or AE) with a reported blood glucose level of less than 54 milligram/deciLitre (3.0 millimole/Litre) or any investigator reported symptomatic hypoglycaemic AE with a reported blood glucose level of less or equal 70 milligram/deciLitre (3.9millimole/Litre) or any severe hypoglycaemic AE. Severe hypoglycaemia is an event that requires the assistance of another person to actively administer carbohydrates or glucagon because the patient is unable to take the substance on his or her own. The confidence intervals mentioned in measure of dispersion are exact 95% confidence interval by Clopper and Pearson. The percentage of patients with at least one hypoglycaemia accompanied by a glucose value less than 54mg/dL alone has also represented separately according American Diabetes Association definition of clinically significant hypoglycaemia.|24 weeks|Full analysis set observed cases (FAS (OC)): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value. These analyses used available data as observed while patients were on treatment. All values collected after a patient started rescue medication were excluded from the analysis.|||Percentage of patients (%)||95% Confidence Interval|Number
2593806|NCT02240680|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.|This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any randomised study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range.|Baseline and Week 24|Full analysis set observed cases (FAS (OC)): Includes all patients randomised in the Treated Set who had a baseline and at least one on-treatment HbA1c value. These analyses used available data as observed while patients were on treatment. All values collected after a patient started rescue medication were excluded from the analysis.|||Percentage (%) of HbA1c||Standard Error|Least Squares Mean
2593807|NCT02240667|Secondary|Number of Patients With the Reason for Definitive Treatment Discontinuation|Number of patients with the reason for definitive treatment discontinuation|Visit 2, 3, 4 and 5 (after approx. 3, 6, 9 and 12 months of treatment)|Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA).|||Participants|||Count of Participants
2593993|NCT02239289|Primary|Flexion-relaxation Ratio|Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.|Week 4||||ratio||Standard Deviation|Mean
2593808|NCT02240667|Secondary|Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit.|Percentage of patients with low, medium or high adherence at the 6-month visit, stratified for dabigatran etexilate and VKA; categorisation is done on the basis of the Morisky questionnaire (high, medium and low adherence with a Morisky score of 0, 1 to 2, and > 2, respectively).|6 month (visit 3)|Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA).|||Percentage of participants|||Number
2593809|NCT02240667|Primary|Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month|Percentage of patients treated with the initially allocated anticoagulant at the 12-month visit, defined as Kaplan Meier estimate at 12 months for persistence, stratified for dabigatran etexilate and VKA.Persistence is defined as the time between initiation and permanent discontinuation of therapy. The initiation date is the documented start of treatment (at visit 1), and the date of permanent discontinuation is the documented permanent discontinuation of dabigatran etexilate or VKA therapy.|12 month (Visit 5)|Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA).|||percentage of participants||95% Confidence Interval|Number
2593810|NCT02240654|Primary|Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources.|"Definition of off-label use of oral dabigatran etexilate (DE) was based on use for a disease/medical condition other than labelled indications,as described/documented in the data source used in the respective countries, taking into account the changes in the label within the study period. The prevalence of potential off-label use among new users of DE during the overall study period is calculated as the proportion of patients meeting the definition of off-label use by dividing the number of index prescriptions that represented off-label use by the total number of index prescriptions.~Two definitions were applied to estimate potential off-label use based on either recorded diagnoses or proxies: a broad definition of on-label prescribing using codes for disease indication e.g.atrial fibrillation(AF) and a restrictive definition excluding patients with conditions for which the drug is not indicated e.g.valvular AF.~SPAF:Stroke & systemic embolism in adult patients with non-valvular AF"|Time period since approval of the SPAF indication in, France: 01 August 2011 to 30 June 2014; Denmark: 01 August 2011 to 30 November 2013; UK: 01 August 2011 to 30 August 2015.|The study population included new users of dabigatran etexilate in the study period. New users were defined as those patients who initiated treatment with dabigatran etexilate during the study period and who had not used it during the previous year.|||percentage of participants||95% Confidence Interval|Number
2593811|NCT02240628|Secondary|Pain Intensity|"A blinded independent observer will rate pain on Propofol injection according to a pain scale.~No pain.~Mild pain(associated with facial expression of pain).~Moderate Pain(Pulling/withdrawal of arm).~Severe Pain(Screaming)."|During Propofol injection.||||participants|||Number
2593812|NCT02240628|Primary|Number of Children in Each Group Who Don't Feel Pain or Have Mild Pain on Propofol Injection.||During propofol injection.||||participants|||Number
2593813|NCT02240589|Secondary|Traumatic Brain Injury Quality of Life Anger (TBI QOL Anger)|The TBI-QOL Anger item bank includes 38 hierarchically ordered items designed to measure the full continuum of anger in a way which is both sensitive and appropriate for TBI. The TBI-QOL Anger item bank can be administered as a computer-adaptive test (CAT), allowing precise measurement of self-reported anger using only 4-8 adaptively selected items. Using CAT technology, an individual participant's responses to the TBIQoL Anger scale generated a T-score (Mean=50; SD=10) with a range of 0 (lowest anger) to 100 (greatest anger).|Week 24||||scaled score||Standard Deviation|Mean
2593814|NCT02240589|Secondary|Behavior Rating Inventory of Executive Function (BRIEF) Inhibit|The Behavior Rating Inventory of Executive Function (BRIEF) Inhibit subscale is a rating scale completed by the participant and independently by an observer that assesses the ability to control impulses (inhibitory control) and to stop engaging in a behavior. The frequency of behaviors indicated by items is rated on a 3-point scale (never, sometimes, often). The raw score for the Inhibit subscale is the sum of ratings for the 8 items included in this measure. This sum was converted to a T-score (mean=50; SD=10) for analysis. Higher scores suggest a higher level of dysfunction in a specific domain of executive functions.|Week 24||||t-score||Standard Deviation|Mean
2593815|NCT02240589|Secondary|Stroop Interference|Stroop Interference Test is a neuropsychological test to assess a person's executive function. Specifically, the test is thought to reflect selective attention, cognitive flexibility and processing speed. The raw score for this measure is the number of items correctly identified within 45 seconds. The raw score was converted to a T-score (mean=50; SD=10) for analysis. Higher scores reflect better performance and less interference on reading ability.|Week 24||||t-score||Standard Deviation|Mean
2593816|NCT02240589|Secondary|Trail Making Part B|Neuropsychological test of visual attention and executive functioning. The trail making tests are thought to reflect a variety of cognitive processes including attention, visual search and scanning, sequencing and shifting, psychomotor speed, abstraction, flexibility, ability to execute and modify a plan of action, and ability to maintain two trains of thought simultaneously. In Trails B, the participant is instructed to draw lines to connect numbers and letters in an alternating numeric and alphabetic sequence as rapidly as possible. Lower scores are better scores and the range of scores can be from 0 to no limit for Trail Making Test part B. This is a timed test and the number of seconds to complete the task is recorded. The unit of measure in seconds is converted to a scaled score (mean =10, SD = 3) using the Heaton et al. norms with lower scores indicating better performance.|Week 24||||scaled score||Standard Deviation|Mean
2593817|NCT02240589|Secondary|BVMT-R Learning|Brief Visuospatial Memory Test-Revised (BVMT-R) Learning measures the correctly recalled designs (i.e., standard scoring of accuracy and location as described in the manual) over 3 learning trials. The Learning raw score is the sum of the higher number of correctly recalled designs on either Trial 2 or Trial 3 minus the number of correctly recalled designs on Trial 1. A higher score is a better score. The raw score was converted to a T-score (Mean=50; SD=10) for analysis.|Week 24||||t-score||Standard Deviation|Mean
2593852|NCT02240030|Secondary|PD Patient Diary|Change in total daily OFF times for 3 consecutive days prior to week 12 visit compared to 3 consecutive days prior to baseline visit. Participants recorded On or Off state in 30 minute intervals during waking hours.|post week 12|12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).|||hours||95% Confidence Interval|Least Squares Mean
2593818|NCT02240589|Secondary|Brief Visuospatial Memory Test - Revised (BVMT-R) Delayed Recall|Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall measures the correctly recalled designs (i.e., standard scoring of accuracy and location as described in the manual) after a 25 minute delay. The delayed recall raw score ranges from 0 to 12 with 12 being the highest and best possible score. The raw score is converted to a T-score (Mean=50; SD=10) which was used for statistical analysis.|Week 24||||t-score||Standard Deviation|Mean
2593819|NCT02240589|Secondary|CVLT-II Trials 1-5 Free Recall Total|Neuropsychological test used to assess an individual's verbal memory abilities. California Verbal Learning Test-Second Edition (CVLT-II) Trials 1-5 Free Recall Total measures the sum of all word list items correctly recalled on learning trials 1 through 5. This raw score is converted to a T-score (Mean=50; SD=10) which was used for statistical analysis. The total A1-5T score reflects accurate recall over the five learning trials of the first list, and is most often used as a summary index of learning on the CVLT-II, with higher scores reflecting better performance.|Week 24||||t-score||Standard Deviation|Mean
2593820|NCT02240589|Primary|California Verbal Learning Test - Second Edition (CVLT-II) - Long Delay Free Recall|Neuropsychological test used to assess an individual's verbal memory abilities. The California Verbal Learning Test-Second Edition (CVLT-II) Long Delay Free Recall measures total word list items recalled after a 20-minute delay. The raw score is converted to a Z-score (Mean=0; SD=1) which was used for statistical analysis. Higher scores reflect worse performance (i.e., more recall errors) on this variable.|Week 24||||z-score||Standard Deviation|Mean
2593821|NCT02240368|Secondary|Entropy Awaking|In each patient the Entropy values at the moment of first signs of awakening. The Entropy monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A Entropy value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer|reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia||||units on a scale||Inter-Quartile Range|Median
2593822|NCT02240368|Secondary|BISPECTRAL Index Awaking|In each patient the Bispectral index values at the moment of first signs of awakening.The Bispectral index monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100 (deepest/highest level of anesthesia). A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer|reported moment of awakening from anesthesia, an average of 1 hours after administration of Anesthesia||||units on a scale||Inter-Quartile Range|Median
2593823|NCT02240368|Primary|Entropy|"The collected values of Entropy will generate a single prediction probability (PK) of agreement between Entropy vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.~Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions."|Entropy values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours||||units on a scale||95% Confidence Interval|Number
2593824|NCT02240368|Primary|BISPECTRAL Index|"The collected values of bispectral index and end tidal sevofluorane will generate a single prediction probability (PK) of agreement between bispectral index vs end-tidal sevofluorane along the whole period of anesthesia for each arm/group.~Prediction probability (PK) is a statistical measure that is particularly suited to assess the performance of anesthetic depth indicators. It quantifies the correlation between observed anesthetic depth and indicator values. PK allows a simple interpretation and, as a non parametric measure, it is independent from scale units and assumptions on underlying distributions."|BISPECTRAL index values from the induction moment to the awakening moment, 1/5 sec sampling rate, an average of 1 hours||||units on a scale||95% Confidence Interval|Number
2593825|NCT02240329|Primary|Number of Coughs in Response to Stimulation With 200 Micro Moles Capsaicin in Solution|The total cough count (CTot) was determined by counting all cough events that occurred following each presentation of capsaicin solution. CTot was made, in real time, by two investigators and confirmed via review of the recorded cough airflow signal. Capsaicin concentration necessary to elicit a two cough threshold response (C2) within 30 seconds of presentation, on at least two (out of three) trials of that concentration, was identified from the cough count record. An average across all measurements was performed for the analysis.|Day 1||||cough events following stimulation||Standard Deviation|Mean
2593826|NCT02240329|Primary|Average Urge to Cough (UTC) Following Administration of 200 Micro Mole Capsaicin Solution Concentration|"Following 30 seconds of tidal breathing (to allow for acclimation to the facemask), participants were instructed to take a sharp breath in whereupon the nebulized capsaicin solution was automatically administered by the dosimeter. Following each aerosol presentation, the participant was instructed to rate their UTC using a modified Borg Rating Scale where 1 = no UTC and 10 = maximum UTC. Between presentations, participants were given a minimum of a one-minute rest period where they were offered water. An average across all measurements was performed for the analysis."|Day 1||||Units on a Borg scale||Standard Error|Mean
2593827|NCT02240186|Secondary|Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)|"The condition-specific Prosthesis Evaluation Questionnaire (PEQ) was used to quantify patient satisfaction with each prosthesis. The outcome was a difference in PEQ scores between the NPMK and MPK measurements.~The PEQ is a self-administered questionnaire composed of nine validated scales (ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility, well being). Scores range from 0 to 100 for each sub-scale. Higher scores indicated a higher functioning prosthesis/quality of life."|Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)|Not all participants completed all the scales in the questionnaire.|||Score on a scale||Standard Deviation|Mean
2593853|NCT02240030|Secondary|UPDRS Part III at 10 Min.|Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 10 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.|week 12|12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).|||units on a scale||95% Confidence Interval|Least Squares Mean
2605760|NCT02107014|Primary|Change in IL-4 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2593828|NCT02240186|Primary|Falls as Assessed by the Prosthesis Evaluation Questionnaire Addendum (PEQ-A)|The Prosthesis Evaluation Questionnaire (PEQ) addendum (PEQ-A) is a self-administered questionnaire to quantify balance confidence, concentration, stumbles, and falls. The outcome will be difference in falls per month between the Non-Microprocessor Knee (NPMK) and MPK measurements. The number of falls was recorded as the sum of items #5 and #7 in the PEQ-A.|Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)|Data for falls were available for analysis on 46 baseline participants, 30 MPK participants, and 17 NMPK participants.|||Falls per month||Inter-Quartile Range|Median
2593829|NCT02240186|Primary|Daily Activity Measured With Triaxial Accelerometers|Measurements will be obtained three times using activity monitors attached to waist, and bilaterally to the ankle and thigh for a period of 4 consecutive days, including 2 weekdays and 2 weekend days. Primary outcome will be the difference in activity level between the NMPK and MPK measurements.|Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)|Activity measurement data were available for analysis on 46 baseline participants, 31 MPK participants, and 18 NMPK participants.|||% of Day||Standard Deviation|Mean
2593830|NCT02240121|Secondary|Number of Participants With SES-CD Score of 0 at Week 52|SES-CD is a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease.|Week 52|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593831|NCT02240121|Secondary|Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) Over Time|Clinical Symptom Remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to each clinical visit being ≤ 10 (from CDAI Item 1); and (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the last 7 days prior to each clinic visit in ≥ 80% of the study visits during the 52-week treatment period, including Week 52. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.|From Baseline to Week 52|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593832|NCT02240121|Secondary|Number of Participants Who Achieved Clinical Remission (Defined as CDAI Score of <150) at Week 16|Clinical remission was defined as a CDAI score of less than 150 points at Week 16. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.|Week 16|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593833|NCT02240121|Primary|Number of Participants With Endoscopic Response at Week 52|Endoscopic response defined as a ≥ 3-point decrease in the SES-CD from baseline to the SES-CD score obtained at Week 52. SES-CD is a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease.|Baseline, Week 52|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593834|NCT02240121|Primary|Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) at Week 52|Clinical Symptom Remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 52 visit being ≤ 10 (from CDAI Item 1); and (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 52 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.|Week 52|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593835|NCT02240121|Primary|Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 2) at Week 52|Clinical Symptom Remission defined by (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 52 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.|Week 52|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593854|NCT02240030|Secondary|Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at Week 12|Patient Global impression of change at treatment visit 4 (week 12) by improvement category. Seven point Likert scale ranging from 1= much worse to 7= much better.|week 12|12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).|||Participants|||Count of Participants
2605761|NCT02107014|Primary|Change in IL-2 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2593836|NCT02240121|Primary|Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1) at Week 52|Clinical symptom remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 52 visit being ≤ 10 (from CDAI Item 1). CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.|Week 52|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593837|NCT02240121|Primary|Number of Participants With Endoscopic Response Between Week 16 and 17|Endoscopic response defined as a ≥ 3-point decrease in the SES-CD from baseline to the SES-CD score obtained between Week 16 and Week 17. SES-CD scores were calculated from centrally-read digital video of ileocolonoscopies performed at baseline and between Week 16 and Week 17. SES-CD is a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease.|Baseline, Week 16 to 17|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593838|NCT02240121|Primary|Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) at Week 16|Clinical Symptom Remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 16 visit being ≤ 10 (from CDAI Item 1); and (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 16 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.|Week 16|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593839|NCT02240121|Primary|Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 2) at Week 16|Clinical Symptom Remission defined by (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 16 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.|Week 16|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593840|NCT02240121|Primary|Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1) at Week 16|Clinical symptom remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 16 visit being ≤ 10 (from CDAI Item 1). CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.|Week 16|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593841|NCT02240108|Secondary|Number of Participants With SES-CD Score of 0 at Week 52|SES-CD is a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease.|Week 52|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593842|NCT02240108|Secondary|Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) Over Time|Clinical Symptom Remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to each clinical visit being ≤ 10 (from CDAI Item 1); and (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the last 7 days prior to each clinic visit in ≥ 80% of the study visits during the 52-week treatment period, including Week 52. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.|From Baseline to Week 52|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593843|NCT02240108|Secondary|Number of Participants Who Achieved Clinical Remission (Defined as CDAI Score of <150) at Week 16|Clinical remission was defined as a CDAI score of less than 150 points at Week 16. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.|Week 16|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593879|NCT02239692|Secondary|Ascending Colon Cleansing Responder Status (ITT)|Percentage of subjects classified as responders, i.e. Ottawa Scale score of either 0 (excellent) or 1 (good), during colonoscopy performed by a colonoscopist blinded to the dosing schedules.|Day 1 (day of colonoscopy)|The ITT analysis set consisted of all randomized subjects.|||percentage of subjects|||Number
2593844|NCT02240108|Primary|Number of Participants With Endoscopic Response at Week 52|Endoscopic response defined as a ≥ 3-point decrease in the SES-CD from baseline to the SES-CD score obtained at Week 52. SES-CD is a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease.|Baseline, Week 52|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593845|NCT02240108|Primary|Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) at Week 52|Clinical Symptom Remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 52 visit being ≤ 10 (from CDAI Item 1); and (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 52 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.|Week 52|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593846|NCT02240108|Primary|Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 2) at Week 52|Clinical Symptom Remission defined by (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 52 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.|Week 52|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593847|NCT02240108|Primary|Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1) at Week 52|Clinical symptom remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 52 visit being ≤ 10 (from CDAI Item 1). CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.|Week 52|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593848|NCT02240108|Primary|Number of Participants With Endoscopic Response Between Week 16 and 17|Endoscopic response defined as a ≥ 3-point decrease in the SES-CD from baseline to the SES-CD score obtained between Week 16 and Week 17. SES-CD scores were calculated from centrally-read digital video of ileocolonoscopies performed at baseline and between Week 16 and Week 17. SES-CD is a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments: rectum, left colon, transverse colon, right colon, and ileum. Scores range from 0 to 60, with higher scores indicating more severe disease.|Baseline, Week 16 to 17|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593849|NCT02240108|Primary|Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1 and 2 Both) at Week 16|Clinical Symptom Remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 16 visit being ≤ 10 (from CDAI Item 1); and (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 16 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.|Week 16|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593850|NCT02240108|Primary|Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 2) at Week 16|Clinical Symptom Remission defined by (2) an abdominal pain (graded from 0 [less severe]-3 [more severe]) rating of ≤ 1 (from CDAI Item 2) on each day for the 7 days prior to the Week 16 visit. CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.|Week 16|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593851|NCT02240108|Primary|Number of Participants Who Achieved Clinical Symptom Remission (From CDAI Item 1) at Week 16|Clinical symptom remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 16 visit being less than or equal to (≤) 10 (from CDAI Item 1). CDAI score is a weighted, composite index of 8 items (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extraintestinal manifestations including fistula, use or non-use of antidiarrheal agents, presence or absence of abdominal mass, hematocrit, and body weight). Scores range from 0 to approximately 600 with higher scores indicating greater disease severity.|Week 16|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2593946|NCT02239679|Secondary|Proportion of Subjects With 0 AKs|Normalized based on number of lesions present at Baseline|Week 24|Analysis population consisted of observed data only.|||Participants|||Count of Participants
2593855|NCT02240030|Secondary|UPDRS Part III Motor Score at 20 Minutes|Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 20 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population) and CVT 301 Low Dose versus Placebo. UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.|at week 12|12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).|||units on a scale||97.5% Confidence Interval|Least Squares Mean
2593856|NCT02240030|Secondary|Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.|Examiner-assessed observation - Subject Achieving Resolution of an OFF to and ON state within 60 Minutes at TV4 - Observed|at week 12|12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).|||Participants|||Count of Participants
2593857|NCT02240030|Primary|Unified Parkinson's Disease Rating Scale (UPDRS) Part III|Primary Efficacy Analysis: Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 30 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.|30 minutes post-dose at week 12|12 participants were randomized but withdrew before receiving any study drug (4 placebo, 2 CVT-301 low-dose, 6 CVT-301 high-dose).|||units on a scale||Standard Error|Least Squares Mean
2593858|NCT02239978|Secondary|Cortical Excitability|Investigators will assess the cortical excitability of the primary motor cortex in a subset of participants both ON and OFF levodopa. Specifically, we used transcranial magnetic stimulation to stimulate the motor cortex, where we measure muscular activity of the arm (i.e. motor evoked potentials; MEPs). The primary outcome variable noted below is the lowest stimulation setting (measured as a percentage) which results in an MEP in 5 of 10 trials.|TMS data was collected ON and OFF medication during one visit. This visit occurred within 3 weeks of the initial postural control assessments.|"As noted in our protocol, TMS was assessed in a subgroup of participants with PD. Seven of the 28 PD participants and 0 of the control group (healthy adults) were assessed. PD participants were assessed ON and OFF levodopa. We chose this approach because 1) this aim was exploratory in nature, and 2) MEPs of healthy adults are well characterized."|||% max stim output||Standard Deviation|Mean
2593859|NCT02239978|Secondary|Change in First Step Length|Investigators will assess (via automated and custom Matlab software) the length of the first step after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).|Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication||||meters||Standard Deviation|Mean
2593860|NCT02239978|Primary|Change in Steps After Postural Perturbation|Investigators will assess (via automated and custom Matlab software) the number of steps taken after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).|Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication|"We were unable to collect reliable data on some of the people with PD while OFF medication, which is why there is a discrepancy between the Parkinson's disease and Parkinson's disease Off Medication arms."|||Number of steps||Standard Deviation|Mean
2593861|NCT02239978|Primary|Change in Movement of Center of Mass (COM) After Postural Perturbation|Investigators will assess (via automated and custom Matlab software) the magnitude of COM movement after a postural perturbation is delivered via motion of the support surface. This will be measured throughout the intervention, as well as at follow up (24 hour later).|Baseline and follow up (24 hours later) both ON and OFF antiparkinson medication|"We were unable to collect reliable data on some of the people with PD while OFF medication, which is why there is a discrepancy between the Parkinson's disease and Parkinson's disease Off Medication arms."|||meters||Standard Deviation|Mean
2593862|NCT02239939|Other Pre-specified|Changes in Lower Extremity Physical Function|SPPB is a measure of lower-extremity function consisting of walking speed, balance, and repeated chair stands. These 3 performance measures are scored from 0 to 4, with 4 indicating the highest level of performance and 0 the inability to complete the task, with a summary score of 0-12.The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability.|Baseline and 22 weeks||||units on a scale||Standard Deviation|Mean
2593863|NCT02239939|Other Pre-specified|Change in Body Weight|Body weight|Baseline and 22 weeks||||kg||Standard Deviation|Mean
2593864|NCT02239939|Secondary|Changes in Self-report on Fatigue Using Pittsburgh Fatigability Scale (PFS)|"Pittsburgh Fatigability Scale (PFS) is a self-administered 10 item assessment. It asks participants to rate the level of physical and mental fatigue they experience or imagine after completing a set of hypothetical activities related to daily life at a fixed intensity and duration. The participant provides a score from 0-5 where 0' equals no fatigue at all, and 5 equals extreme fatigue."|baseline and 22 weeks||||units on a scale||Standard Deviation|Mean
2593865|NCT02239939|Secondary|Change in Hip Bone Density|Hip bone density as measured by DXA.|Basleine and 22 weeks||||g/cm2||95% Confidence Interval|Mean
2593866|NCT02239939|Primary|Change in Lean Mass Measured by DXA|Lean body mass (Whole body and lower-extremity lean mass are used in total calculation).|Baseline and 22 weeks||||Kg||Standard Deviation|Mean
2593867|NCT02239926|Secondary|Mean Abdominal Pain|Daily abdominal pain intensity was rated using an 11-point (0-10) numeric rating scale, with 0 being no pain, and 10 being the worst pain imaginable. Participants were asked to rate their worst abdominal pain over the past 24 hours.|baseline to 4 weeks|The one subject who completed the study did not have complete data, so no analysis was performed. Study was terminated due to difficulty with enrollment.||||||
2593868|NCT02239926|Primary|Change From Baseline in Diarrhea Using the Bowel Symptom Score (BSS).|BSS is a 100-mm visual analog scale for each symptom of Irritable Bowel Syndrome (IBS) (pain or discomfort, bloating, and diarrhea) with an overall severity score. Lower scores indicate symptoms are not present and higher scores indicate severe symptoms.|baseline to 4 weeks|The one subject who completed the study did not have complete data, so no analysis was performed. Study was terminated due to difficulty with enrollment.||||||
2593947|NCT02239679|Secondary|Proportion of Subjects With 0 AKs|Normalized based on number of lesions present at Baseline|Week 12|Analysis population consisted of observed data; ie. subjects with data at Week 12.|||Participants|||Count of Participants
2593869|NCT02239770|Secondary|Mean Systolic Blood Pressure|Systolic blood pressure was measured using an electronic sphygmomanometer just prior to film administration and at every 30 minutes after film administration for the duration of each study visit.|Part 1: Systolic blood pressure was measured at baseline and at every 30 minutes, up to 180 minutes post film administration. Part 2: Systolic blood pressure was measured at baseline and at every 30 minutes, up to 660 minutes post film administration.|Participants in Part 1 of the study were not assessed past 180 minutes post film administration, as this was the extent of the study visit.|||mmHg||Standard Deviation|Mean
2593870|NCT02239770|Secondary|Questionnaire of Smoking Urges-Brief Mean Total Score by Dose Group|"The Questionnaire of Smoking Urges-Brief (QSU-Brief) with a possible total score range of 10 to 70 was used to measure cigarette craving at baseline and at several points throughout the study visit for each participant. A score of 10 on this scale indicates very low cigarette craving, while a score of 70 indicates very high cigarette craving.~Part 1: The QSU-Brief was measured at baseline and at 15, 35, 55, 80, 140, and 200 minutes post film administration.~Part 2: The QSU-Brief was measured at baseline and at 50, 110, 230, 290, 410, 470, 590, and 690 minutes post FIRST film administration."|Part 1: The QSU-Brief was measured at baseline and at 15, 35, 55, 80, 140, and 200 minutes post film administration. Part 2: The QSU-Brief was measured at baseline and at 50, 110, 230, 290, 410, 470, 590, and 690 minutes post FIRST film administration.|This was a two part study. Participants in Part 1 and Part 2 were not assessed on the QSU-Brief measure at the same time intervals due to the differing study visit structures.|||score on a scale||Standard Deviation|Mean
2593871|NCT02239770|Primary|Peak Plasma Nicotine Concentrations Following Ingestion of a Single (Phase 1) or Repeated (Phase 2) Doses of Nicotine Film|"In Phase 1, a trained nurse will implant an intravenous (IV) indwelling catheter in each participant. Participants will place a film containing zero, 2, or 4 mg of nicotine in their mouths and blood will be drawn every 10 minutes thereafter for the next 60 minutes, and then every 30 minutes for the next 2 hours (11 blood draws in all over 3 hours after using the nicotine film).~In Phase 2, all 12 participants will receive an IV catheter and randomly allocated to consume 4 films over 12 hours in each of the following orders (a) 0,0,0,0 mg (b) 2,2,2,2 or (c) 4,4,0,4. A blood sample will be drawn at baseline prior to each film administration, and then at 30, 45, 60 and 120 minutes after each film administration and when the film is reported dissolved (20 blood draws in total)."|10 min - 12 hours|Because the placebo nicotine film does not deliver any nicotine to the blood, peak plasma nicotine levels cannot be observed in the 0 mg Nicotine Film arm (Part 1) and 0, 0, 0, 0 mg Nicotine Film Regimen (Part 2).|||ng/mL||Full Range|Mean
2593872|NCT02239744|Secondary|Fractional Exhaled Nitric Oxide|FeNO is an established biomarker of respiratory inflammation, and has been widely used in epidemiological studies because of its high sensitivity, specificity and non-invasive nature. We measured FeNO levels using a portable NIOX MINO machine (Aerocrine AB, Solna, Sweden) according to standardized procedures by the American Thoracic Society and the European Respiratory Society.|within 1 hour after the two-day intervention||||ppb||Standard Deviation|Geometric Mean
2593873|NCT02239744|Primary|Lung Function|A respiratory physician measured forced vital capacity, forced expiratory volume in 1 second and peak expiratory flow of each participant using the JAEGER Masterlab equipment (Würzburg, Germany) that meets the American Thoracic Society criteria. The volume signal was calibrated at least once on a testing day with a 3.0 L syringe connected to the pneumotachograph in accordance with the manufacturers' recommendations. We instructed participants to perform at least three forced expiratory lung function maneuvers in order to obtain a minimum of two acceptable and reproducible values, and we recorded the best results.|Within 1 hour after the end of the two-day intervention|Ultimately, all 35 participants completed this study.This crossover study autonomically allows each subject to serve as his or her own control over time.|||L||Standard Deviation|Geometric Mean
2593874|NCT02239744|Secondary|Blood Pressure|After sitting in a quiet room for at least 5 min, participants had their left upper arm BP measured by trained technicians using a mercury sphygmomanometer at least three times with 2-min minimum intervals between measurements. The second and third sets of readings were averaged to obtain systolic BP and diastolic BP. Pulse pressure was calculated as the difference between systolic BP and diastolic BP. If the differences among the three measurements were bigger than 5 mmHg, a new round of measurements were arranged.|Within one hour after the 2-day intervention||||mmHg||Standard Deviation|Geometric Mean
2593875|NCT02239744|Primary|Circulating Biomarkers|Peripheral blood samples (5 ml) were drawn by a nurse, separated into serum and plasma, and stored at -80 ℃ within 30 minutes. We measured the levels of 14 circulating biomarkers: (1) 8 biomarkers of inflammation, including C-reactive protein (CRP), fibrinogen, P-selection, monocyte chemoattractant protein-1 (MCP-1), interleukin-1b, interleukin-6, tumor necrosis factor-α (TNF-α) and myeloperoxidase; (2) 4 biomarkers of coagulation, including soluble CD40 ligand (sCD40L), plasminogen activator inhibitor-1, tissue plasminogen activator and D-Dimer; and (3) 2 biomarkers of vasoconstriction, including endothelin-1 and angiotensin-converting enzyme.|Blood samples were drawn within one hour after the intervention, and lab analysis was completed in the next 10 days||||ng/ml||Standard Deviation|Geometric Mean
2593876|NCT02239692|Secondary|Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis)|Laboratory parameters included routine haematology, clinical chemistry, coagulation and urinalysis. With the exception of urinalysis and urine pregnancy test, which was performed as dip-stick analyses at the trial site, all laboratory tests were analysed by a central laboratory.|From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)|The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.|||subjects|||Number
2593877|NCT02239692|Secondary|Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure)|Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic).|From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)|The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.|||subjects|||Number
2593878|NCT02239692|Secondary|Frequency and Intensity of Adverse Events||From baseline (screening) up to day 10 after colonoscopy|The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.|||subjects|||Number
2593948|NCT02239679|Secondary|Subject Satisfaction Score|"Subject satisfaction score~= Excellent (very satisfied)~= Good (moderately satisfied)~= Fair (slightly satisfied)~= Poor (not satisfied at all) Unknown"|Week 52||||Participants|||Count of Participants
2593880|NCT02239692|Primary|Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale|Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).|Day 1 (day of colonoscopy)|The per-protocol (PP) analysis set consisted of all the subjects included in ITT analysis set, but excluding subjects with major protocol deviations (18 subjects) that would impact efficacy analysis.|||score on a scale||Standard Deviation|Mean
2593881|NCT02239692|Primary|Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale|Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).|Day 1 (day of colonoscopy)|The ITT analysis set consisted of all randomized subjects.|||score on a scale||Standard Deviation|Mean
2593882|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|52 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593883|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|36 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593884|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593885|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|12 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593886|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|4 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593887|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24-48 hours after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593888|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline||||Participants|||Count of Participants
2593889|NCT02239679|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Screening||||Participants|||Count of Participants
2593949|NCT02239679|Secondary|Proportion of Subjects With 0 AKs|Normalized based on number of lesions present at Baseline|Week 4|Analysis population consisted of observed data; ie. subjects with data at Week 4.|||Participants|||Count of Participants
2593890|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|52 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593891|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|36 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593892|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593893|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|12 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593894|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|4 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593895|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24-48 hours after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593896|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline||||Participants|||Count of Participants
2593897|NCT02239679|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Screening||||Participants|||Count of Participants
2593898|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|52 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593899|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|36 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593900|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|24 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593901|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|12 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593902|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|4 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593903|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|24-48 hours after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593904|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 minutes after PDT #1||||Participants|||Count of Participants
2593905|NCT02239679|Other Pre-specified|Stinging/Burning|"﻿Immediately after PDT, the most intensive, acute perception of Stinging/Burning DURING treatment will be recorded.~STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable"|During PDT #1||||Participants|||Count of Participants
2593906|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline||||Participants|||Count of Participants
2593907|NCT02239679|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Screening||||Participants|||Count of Participants
2593908|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|52 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593909|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|36 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593910|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24 weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593911|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|12 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593912|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|4 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593913|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24-48 hours after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593914|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 minutes after PDT #1||||Participants|||Count of Participants
2593915|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline||||Participants|||Count of Participants
2593916|NCT02239679|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Screening||||Participants|||Count of Participants
2593917|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|52 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593918|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|36 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593992|NCT02239289|Secondary|Lumbo-pelvic Range of Motion During Trunk Flexion-extension|Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.|Week 1||||Degrees||Standard Deviation|Mean
2593919|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593920|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|12 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593921|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|4 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593922|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24-48 hours after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593923|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 minutes after PDT #1||||Participants|||Count of Participants
2593924|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline||||Participants|||Count of Participants
2593925|NCT02239679|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Screening||||Participants|||Count of Participants
2593926|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|52 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593927|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|36 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593928|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|24 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593929|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|12 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593930|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|4 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2594365|NCT02233738|Secondary|Short Inventory of Problems (SIP) at Baseline|Min value:0 Max value: 45 Higher score indicates higher number of consequences from alcohol and drug use|30 days prior to Baseline|Short Inventory of Problems – Total Score at Baseline|||score on a scale||Standard Deviation|Mean
2593931|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|24-48 hours after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593932|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|Baseline||||Participants|||Count of Participants
2593933|NCT02239679|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|Screening||||Participants|||Count of Participants
2593934|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|52 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593935|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|36 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593936|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593937|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|12 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593938|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|4 Weeks after PDT #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593939|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24-48 hours after photodynamic therapy (PDT) #1|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593940|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline||||Participants|||Count of Participants
2593941|NCT02239679|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Screening||||Participants|||Count of Participants
2593942|NCT02239679|Secondary|Duration of Response|Duration of response is the elapsed number of weeks from the Baseline visit until a lesion recurred or Week 52, whichever comes first|within 52 weeks after Baseline|Subjects who discontinued prior to Week 52 were excluded; analysis used observed data only.|||weeks||Standard Deviation|Mean
2593943|NCT02239679|Secondary|Recurrence Rate|Recurrence rate of all lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline).|Week 52|Analysis population consisted of observed data only|||number of lesions|number of lesions||Count of Units
2593944|NCT02239679|Secondary|Proportion of Subjects With 0 AKs|Normalized based on number of lesions present at Baseline|Week 52|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593945|NCT02239679|Secondary|Proportion of Subjects With 0 AKs|Normalized based on number of lesions present at Baseline|Week 36|Analysis population consisted of observed data only|||Participants|||Count of Participants
2593950|NCT02239679|Primary|Total Number of AKs in Treatment Area|Count of observed lesions in the treatment area, which include lesions that recurred after on-study cryotherapy as well as newly occurring lesions. AK lesions in the treatment area at baseline (maximum of 2) were excluded for this endpoint.|Week 52|Analysis population consisted of observed data; ie. subjects remaining on-study at Week 52.|||lesions||Standard Error|Least Squares Mean
2593951|NCT02239640|Other Pre-specified|Incidence of Procedure Related Serious Adverse Events|Any procedure related serious adverse events occurring upon insertion of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure.|up to 90 days post index procedure||||Participants|||Count of Participants
2593952|NCT02239640|Other Pre-specified|Time to Revascularization|Arterial access puncture to revascularization measured in minutes. Lower values indicate shorter time to revascularization and vice versa.|Day 0-At the completion of the thrombectomy procedure|939 patients were analyzed|||minutes||Standard Deviation|Mean
2593953|NCT02239640|Other Pre-specified|Incidence of Device Related Serious Adverse Events|Any device-related serious adverse events associated with the use of a Covidien/Medtronic market-released neurothrombectomy device during the index stroke procedure up to 90 days post index stroke procedure.|up to 90 days post index procedure||||Participants|||Count of Participants
2593954|NCT02239640|Other Pre-specified|Number of Participants With Good Functional Outcome (mRS 0-2)|"Score based on modified Rankin Scale (mRS). The modified Rankin Scale (mRS) is a scale used to measure the degree of disability or dependence in daily activities of people who has had a stroke.~Clasiffication:~0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead. (lower values represent less disability)"|90 days post index procedure|906 participants contributed to this analysis|||Participants|||Count of Participants
2593955|NCT02239640|Other Pre-specified|All-cause Mortality||up to 90 days post index procedure||||Participants|||Count of Participants
2593956|NCT02239640|Secondary|Incidence of Neurological Events of Interest|Evaluate events causing neurological deterioration (defined as ≥ 4 worsening points from baseline on the NIHSS scale)|up to 90 days post index procedure||||Participants|||Count of Participants
2593957|NCT02239640|Primary|Number of Participants Assessed for Revascularization With mTICI Grades 2b-3|"Assess revascularization using modified Thrombolysis in Cerebral Infarction (mTICI) score at the end of the procedure. This scale determines the response of therapy for ischemic stroke based on angiographic appearances of the treated occluded vessel and the distal branches.~Classification:~grade 0: no perfusion grade 1: antegrade reperfusion past the initial occlusion, but limited distal branch filling with little or slow distal reperfusion grade 2a: antegrade reperfusion of less than half of the occluded target artery previously ischemic territory grade 2b: antegrade reperfusion of more than half of the previously occluded target artery ischemic territory grade 3: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches (higher values represent better outcomes)"|Day 0-At the completion of the thrombectomy procedure|824 participants contributed to this analysis|||Participants|||Count of Participants
2593958|NCT02239601|Post-Hoc|Vibration Sensory Outcome Stratified by Patient Activity Level|Measuring Activity Participants were asked about their level of exercise per week at each assessment visit. Participants were considered active if they reported engaging in any form of moderate activity at least 4 times a week (consistent with recommended physical activity guidelines beyond activities of daily living such as walking to the bus or walking the dog around the block) at least 4 times per week on at least 3 out of 4 reassessment visits. Types of reported activities included cycling, running, yoga, swimming, Zumba, dance classes, and tennis. Walking was included if it was at least 30 minutes at a moderate pace. This sub-analysis re-defined the groups as 'active' and 'less active' for the comparison of vibration QST data. This was done to observe the possible impact of exercise on sensory preservation|administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points||||micrometers (µm)||Inter-Quartile Range|Median
2593959|NCT02239601|Secondary|Grip Strength|Hand Dynamometry records grip strength in kgs and was used as a measure of function (3 trials). The dominant hand was tested using the Jamar dynamometer (Patterson medical, USA) in the 2nd handle position. All 48 participants were right handed.|administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points||||kgs||Standard Deviation|Mean
2593960|NCT02239601|Secondary|Pain Pressure Thresholds|Pressure Algometry (Somedic AB, Sweden) measured pressure/pain thresholds. A hand-held device applied perpendicular to the muscles being tested. Increasing pressure is applied until the participant determines that the sensation has changed from a feeling of pressure to a feeling of pain and force (Kpa) is recorded. When tested at a distant site from the source of pain this test measures central sensitization. Lower pressure values (more sensitive to noxious stimuli) suggest impaired central pain and/or diminished descending inhibition pathway. The left quadriceps muscle was tested as a measure of central sensitization.|administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points||||kpa||Standard Deviation|Mean
2593961|NCT02239601|Secondary|Vibration Sensory Analysis|"Vibration analysis testing for perception thresholds are specific to Aβ nerve fibres. The TSAII Vibration Sensory Analyzer (VSA): Medoc, Israel, was used. The pulp of the index finger lightly touches the sensor that delivers random and varying vibration amplitudes (µm). The participant responds yes/no to sensing the vibration. Vibration perception was selected for its sensitivity and has been suggested to be the first clinical sign of CIPN symptoms and was tested bilaterally. Low score indicates better perception while a higher score is poorer sensation. Perception score reported in micrometers (up to 4cm)"|administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 6 months post-chemotherapy) and mixed models accounted for all time points||||micrometers (µm)||Inter-Quartile Range|Median
2593962|NCT02239601|Primary|Percentage of Participants With Neuropathic Pain Defined by the Self Report Version of Leeds Assessment for Neuropathic Symptoms and Signs (S-LANSS).|a 7 item patient reported questionnaire and was used to confirm the presence of neuropathic pain. The score ranges from 0-19 (no symptoms=0, sever symptoms=19) with a score above 12 indicative of neuropathic pain/symptoms. S-LANSS was chosen because of its' specificity and accuracy in a cancer population. Participants were requested to answer specifically for the hands, not feet.|administered on each re-assessment (Visit 1 - pre-chemotherapy, Visit 2 - half-way through chemotherapy, Visit 3 - end of chemotherapy, Visit 4 - 3 months post-chemotherapy) and mixed models accounted for all time points||||percentage of patients|||Number
2593963|NCT02239601|Primary|Disability of the Arm, Shoulder and Hand (DASH)|A 30 item participant reported questionnaire commonly used to gauge upper limb function. Each item is scored 1-5 with 1 being 'no difficulty' and 5 being 'unable'. Overall score calculated as: [average response (sum of responses divided by number of responses) -1] x 25 to give a score out of 100. Minimum score is 30 with a maximum score of 150. The DASH was chosen because of high test-retest reliability and the responsiveness and construct validity in patients with breast cancer over other quality of life measures. A minimal clinical important difference is a change score of 15. Higher score indicates more impairment to the upper limb|administered on each re-assessment (pre-chemotherapy, mid-way through docetaxel chemotherapy, end of chemotherapy, 6 months post-chemotherapy) and mixed models accounted for all time points||||units on a scale||Inter-Quartile Range|Median
2593964|NCT02239601|Primary|Percentage of Participants With 'Pain' or 'no Pain' as Measured by the Numeric Pain Rating Scale|Numeric Pain Rating Scale - pain rating scale 0-10 (0= no pain to 10= most pain imaginable). Reported as percentages of participants with pain (1-10) vs no pain (0)|Regression models of pain reported over time (mid-docetaxel chemotherapy- 6 months post-chemotherapy). Mid-chemotherapy time frame participants were re-assessed after the 2 round of TC and 4th round of FECD.||||percentage of participants|||Number
2593965|NCT02239562|Secondary|Number of Participants With Anti-sPIF Antibodies and Drug Interactions|Following sPIF administration, using a validated assay, serum samples were tested for anti-sPIF antibodies|29 Day||||participants|||Number
2593966|NCT02239562|Primary|Safety/Tolerability Measured by Clinical Laboratory Tests, Metabolics, Cytokines, Anti-PIF Antibody, Periodic Physical Examination, Including Vital Signs Measurements and 12-lead ECG|"Single Ascending Dose (SAD):~Adverse events, concomitant medications: Days 1, 2, 3, 5, 8 Vital signs, Physical exams: Days 1, 2, 8 Complete blood counts (CBC), Serum chemistry, Liver function tests, Pharmacokinetics: Days 1, 2, 8 Lipids, Coagulation, Urinalysis, Pregnancy test: Days 1, 8 EKG, chest x-ray (CXR): Days 1 and 8~Multiple Ascending Dose (MAD):~Adverse events, concomitant medications: Days 1, 2, 3, 4, 5, 8, 15, 29 Vital signs, Physical exams: Days 1, 2, 3, 4, 5, 8, 15, 29 CBC, Serum chemistry, Liver function tests, Pharmacokinetics: Days 1, 3, 5, 8, 15, 29 Lipids, Coagulation, Urinalysis, Pregnancy test, EKG: Days 1, 5, 29 CXR: Days 1, 29"|29 Day|All patients participating in each arm were assessed for adverse events by symptoms, physical examination and laboratory studies.|||Participants|||Count of Participants
2593967|NCT02239536|Secondary|Lateral Margin|Observation of maring on a recsected specimen|2 weeks after||||Participants|||Count of Participants
2593968|NCT02239536|Primary|Complete Resection Rate|Complete resection was defined as the absence of residual polyp in the resection margin|2 weeks after||||Participants|||Count of Participants
2593969|NCT02239510|Secondary|Change in Satisfaction With Bowel Habit|Change from before treatment to after treatment on patient satisfaction with bowel habit The Subject's Global Assessment (SGA) of Satisfaction with Bowel Habit was used to measure this outcome. Patients were asked how satisfied they have been with their bowel habits in the previous week on a scale of 0 (Unsatisfied) to 100 (Very Satisfied).|12 weeks||||scores on a scale||Standard Deviation|Mean
2593970|NCT02239510|Secondary|Change in Assessment of Bowel Habit|Change from before treatment to after treatment in assessment of bowel habit The Subject's Global Assessment (SGA) of Bowel Habit was used to measure this outcome. Patients were asked how bothersome their constipation was in the past week on a scare from 0 (Absent) to 100 (Very Severe).|12 weeks||||scores on a scale||Standard Deviation|Mean
2593971|NCT02239510|Secondary|Number of Participants With Relief|"Change from before to after treatment in patient assessment of relief - The Subject's Global Assessment (SGA) of Relief was used to measure this outcome. In evaluating subject's response to SGA of relief, subject's who respond with either completely relieved or considerably relieved for at least 50% of the weeks at the end point or somewhat relieved for 100 % of the weeks at the end point will be considered responders to therapy."|12 weeks||||Participants|||Count of Participants
2593972|NCT02239510|Primary|Change in Number of Bowel Movements Per Week|Change from before to after in number of weekly bowel movements|12 weeks||||weekly bowel movements||Standard Deviation|Mean
2593973|NCT02239380|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study (Day 12), that were absent before treatment or that worsened relative to pre-treatment state. AEs include both serious and non-serious adverse events.|Baseline up to 7 days after last dose of study drug administration (up to 12 days)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2593974|NCT02239380|Secondary|Time to Relapse Following The Administration (Either Initial or Any Dose) of Study Drug|Time to relapse (in minutes) was defined as duration from the time of study drug administration to the time of relapse, as determined by investigator. Participants whose seizure stops within 10 minutes without receiving the prohibited medications were analyzed in this outcome measure.|24 hour post Dose 1; 24 hour post Dose 1 or 2|FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||minutes||Full Range|Median
2594828|NCT02229227|Secondary|Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain at Week 26|Percentage of participants achieving HbA1c <7.0% without weight gain are presented.|Week 26|FA Population.|||Percentage of participants|||Number
2593975|NCT02239380|Secondary|Time to Resolution of Seizures From The Administration (Either Initial or Any Dose) of Study Drug|Time to resolution (in minutes) was defined as the duration between the administration of study drug until the seizure resolved without receiving the prohibited medications.|10 minutes post Dose 1; 10 minutes post Dose 1 or 2|FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG. Here, 'n' signifies those participants who were evaluable for specific category.|||minutes||Full Range|Median
2593976|NCT02239380|Secondary|Percentage of Participants Who Achieved Seizure Free Interval of At Least 24 Hours After Administration (Either Initial or Any Dose) of Study Drug|Percentage of participants whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to be seizure-free for at least 24 hours post-dose were analyzed and reported in this outcome measure.|24 hour post Dose 1; 24 hour post Dose 1 or 2|FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG.|||percentage of participants|||Number
2593977|NCT02239380|Secondary|Percentage of Participants Who Achieved Seizure Free Interval of At Least 12 Hours After Administration (Either Initial or Any Dose) of Study Drug|Percentage of participants whose seizures stopped within 10 minutes after the administration of initial dose (Dose 1) of study drug and after any study drug dose (either Dose 1 or Dose 2 [in 10 to 30 minutes from the initial dose]), who continued to be seizure-free for at least 12 hours post-dose were analyzed and reported in this outcome measure.|12 hour post Dose 1; 12 hour post Dose 1 or 2|FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG.|||percentage of participants|||Number
2593978|NCT02239380|Secondary|Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Any Dose of Study Drug|Percentage of participants whose initial seizure stopped within 10 minutes after the administration of study drug (either Dose 1 or 2 [in 10 to 30 minutes from the initial dose]) and who continued seizure-free for at least 30 minutes were analyzed and reported in this outcome measure.|30 minutes post Dose 1 or 2|FAS included all participants who received at least 1 dose of study drug, excluded those participants whose SE or repetitive SE/cluster seizure was determined on the EEG.|||percentage of participants||95% Confidence Interval|Number
2593979|NCT02239380|Primary|Percentage of Participants Who Achieved Seizure Free Interval of At Least 30 Minutes After Initial Dose (Dose 1) of Study Drug|Participants with clinical benefit were defined as participants whose initial seizure stopped within 10 minutes after initial dose (Dose 1) and who continued seizure-free for at least 30 minutes after the completion of initial dose (Dose 1).|30 minutes post Dose 1|Full analysis set (FAS) included all participants who received at least 1 dose of study drug, excluded those participants whose status epilepticus (SE) or repetitive SE/cluster seizure was determined on the electroencephalography (EEG).|||percentage of participants||95% Confidence Interval|Number
2593980|NCT02239328|Primary|Patient Reported Outcomes Measurement Information System (PROMIS) Scores.|Enrolled subjects with lung or esophageal cancer will be asked to complete an on-line (web-based) survey (PROMIS) using a computer. Most patients will only be asked to complete this survey once, but some patients will be asked to answer the questions a second or third time over a maximum five year period. The PROMIS assessment center was used to develop and administer patient reported outcomes (PROs) for each of these five cancer domains. PROMIS scores are continuous and range from 0-100. Total scores were calculated and calibrated to the weighted distribution of scores from a large representative sample of the U.S. general population using the 'T-score' algorithm 18. The T-scores for the study population are calibrated to the surveyed population mean of 50 and standard deviation of 10, such that a study patient with a T-score of 40 is one standard deviation below the U.S. general population mean.|Over a 3 year period|All patients who completed at least 1 PROMIS survey who had a diagnosis of lung cancer.|||units on a scale||Standard Deviation|Mean
2593981|NCT02239289|Secondary|Lumbo-pelvic Range of Motion During Trunk Flexion-extension|Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.|Week 4||||Degrees||Standard Deviation|Mean
2593982|NCT02239289|Secondary|Lumbo-pelvic Range of Motion During Trunk Flexion-extension|Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.|Week 3||||Degrees||Standard Deviation|Mean
2593983|NCT02239289|Secondary|Lumbo-pelvic Range of Motion During Trunk Flexion-extension|Range of motion is recorder throught 8 kinematic markers placed on the right lower limb and the back of each participant during every trials of each session.|Week 2||||Degrees||Standard Deviation|Mean
2593984|NCT02239289|Secondary|Pain Intensity in the Past Week|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 4||||Units on a scale||Full Range|Mean
2593985|NCT02239289|Secondary|Pain Intensity in the Past Week|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 3||||Units on a scale||Full Range|Mean
2593986|NCT02239289|Secondary|Current Pain Intensity|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 4||||Units on a scale||Full Range|Mean
2593987|NCT02239289|Secondary|Current Pain Intensity|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 2||||Units on a scale||Full Range|Mean
2593988|NCT02239289|Secondary|Fear of Movement Level|Tampa scale for kinesiophobia ranges from 0 to 68. Higher score indicates higher fear of movement level.|Week 4||||units on a scale||Full Range|Mean
2593989|NCT02239289|Secondary|Current Pain Intensity|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 3||||Units on a scale||Full Range|Mean
2593990|NCT02239289|Secondary|Pain Intensity in the Past Week|101-points numerical rating scale that ranges from 0 (no pain) to 100 (worst possible pain).|Week 2||||Units on a scale||Full Range|Mean
2593991|NCT02239289|Secondary|Disability Level|Oswestry disability index ranges from 0 to 100. A higher score indicates higher disability.|Week 4||||units on a scale||Full Range|Mean
2596233|NCT02212834|Primary|Number of Breast Cancers Detected|Number of second breast cancers detected in the 12 months after surveillance mammogram or breast MRI|12 months post surveillance exam||||cancers detected|exams||Number
2593994|NCT02239289|Primary|Flexion-relaxation Ratio|Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.|Week 3||||ratio||Standard Deviation|Mean
2593995|NCT02239289|Primary|Flexion-relaxation Ratio|Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.|Week 2||||ratio||Standard Deviation|Mean
2593996|NCT02239289|Primary|Flexion-relaxation Ratio|Flexion-relaxation ratio is calculated by dividing muscle activity (EMG) during trunk flexion by muscle activity during full-flexed position. EMG of lumbar paraspinal muscles is recorder through surface EMG during every trials of each session.|Week 1||||Ratio||Standard Deviation|Mean
2593997|NCT02239120|Secondary|Any Bleed (Investigator-reported)|"This was the sum of all major and minor bleeds (Minor bleeds were clinical bleeds that did not fulfil the criteria for major bleeds), regardless of severity.~The annualised event rate represents the average number of events per patient during a 1-year period."|Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.|TS|||Annualised event rate (%/ year)|||Number
2593998|NCT02239120|Secondary|Adjudicated Life-threatening Bleed|"Major bleeds were to be classified as life-threatening if they met one or more of the following criteria: fatal bleed, symptomatic intracranial bleed, reduction in haemoglobin of at least 5 grams/ deciliter (g/dL), transfusion of at least 4 units of packed red blood cells (equivalent to 9 units in Japan), associated with hypotension requiring the use of intravenous inotropic agents, or necessitated surgical intervention.~The annualised event rate represents the average number of events per patient during a 1-year period."|Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.|TS|||Annualised event rate (%/ year)|||Number
2593999|NCT02239120|Secondary|Adjudicated Fatal Bleed|Adjudicated fatal bleeding was defined as a bleeding event which the Independent Event Adjudication Committee (IAC) determined as the primary cause of death or contributed directly to death. The annualised event rate represents the average number of events per patient during a 1-year period. Because there were 0 events in one treatment group, the hazard ratio is unable to be calculated.|Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.|TS|||Annualised event rate (%/ year)|||Number
2594000|NCT02239120|Secondary|Adjudicated Intracranial Hemorrhage|"Adjudicated intracranial haemorrhage comprised the subtypes of intracerebral bleeds, intraventricular bleeds, subdural bleeds, epidural bleeds, and subarachnoid bleeds. Microbleeds did not qualify as intracranial haemorrhage, except when they were symptomatic.~The annualised event rate represents the average number of events per patient during a 1-year period."|Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.|TS|||Annualised event rate (%/ year)|||Number
2594001|NCT02239120|Secondary|All-cause Death|All-cause death is presented. The annualised event rate represents the average number of events per patient during a 1-year period.|From randomisation until full follow up period, up to 43 months|RS|||Annualised event rate (%/ year)|||Number
2594002|NCT02239120|Secondary|Disabling Stroke|Disabling stroke (modified Rankin Scale greater than or equal to 4, as determined 3 months after recurrent stroke) is presented. The annualised event rate represents the average number of events per patient during a 1-year period.|From randomisation until full follow up period, up to 43 months|RS|||Annualised event rate (%/ year)|||Number
2594003|NCT02239120|Secondary|Adjudicated Composite of Non-fatal Stroke, Non-fatal Myocardial Infarction, or Cardiovascular Death|Adjudicated composite of non-fatal stroke, non-fatal myocardial infarction (MI), or cardiovascular death is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period.|From randomisation until full follow up period, up to 43 months|RS|||Annualised event rate (%/ year)|||Number
2594004|NCT02239120|Secondary|Adjudicated Ischaemic Stroke|Adjudicated ischaemic stroke is a key secondary endpoint. The annualised event rate represents the average number of events per patient during a 1-year period.|From randomisation until full follow up period, up to 43 months|RS|||Annualised event rate (%/ year)|||Number
2594005|NCT02239120|Primary|First Major Bleed (Adjudicated)|"First major bleed is primary safety endpoint. Major bleeds were defined according to the International Society of Thrombosis and Haemostasis (ISTH) definition as follows:~Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or,~Bleeding (which should be overt) associated with a reduction in haemoglobin of at least 2 grams/ decilitre (g/dL) (1.24 millimoles Per Litre (mmol/L)), or leading to transfusion of ≥2 units of blood or packed cells (equivalent to ≥4.5 units in Japan); the haemoglobin drop should be considered to be due to and temporally related to the bleeding event and/or,~Fatal bleed. The annualised event rate represents the average number of events per patient during a 1-year period."|Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.|Treated set (TS): TS consisted of all patients who were treated with at least 1 dose of trial medication. The start date of the observation period for this population was the date of first intake of trial medication.|||Annualised event rate (%/ year)|||Number
2594006|NCT02239120|Primary|Adjudicated Recurrent Stroke|Adjudicated recurrent stroke (ischemic, hemorrhagic, or unspecified) is presented. The annualised event rate represents the average number of events per patient during a 1-year period.|From randomisation until full follow up period, approximately 43 months.|Randomised set (RS): RS consisted of all participants who were randomised, regardless of whether they took trial medication. The start date of the observation period for this population was the date of randomisation.|||Annualised event rate (%/ year)|||Number
2594007|NCT02239094|Primary|Montgomery-Asberg Rating Scale for Depression (MADRS) at Week8|"The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression.~Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe)."|Week 8||||units on a scale||Standard Deviation|Mean
2605762|NCT02107014|Primary|Change in IL-1Ra From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2594008|NCT02239094|Primary|Montgomery-Asberg Rating Scale for Depression (MADRS)|"The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression.~Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe)."|Baseline||||units on a scale||Standard Deviation|Mean
2594009|NCT02238977|Primary|Depression Severity|"Depression severity as measured by the 25-item Hamilton Depression Rating Scale. The Hamilton Depression Rating Scale has proven useful for determining the level of depression before, during, and after treatment. It is based on the clinician's interview with the patient/participant and probes symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels and weight loss. The rater enters a number for each symptom construct that ranges from 0 (not present) to 4 (extreme symptoms). The higher the total score the more severe the depression. The scale is scored by summing the total of all items. The maximum possible total score is 66 and the minimum is 0. A score > 17 is considered compatible with a diagnosis of major depression. A score < 10 is considered clinical remission.~The interview and scoring takes about 15 minutes."|up to 12 weeks|Study was terminated due to inability to recruit. No subjects were recruited for Fluoxetine arm.|||units on a scale|||Number
2594010|NCT02238925|Secondary|Cmax||Induction 1, Day 5||||ng/ml||Standard Deviation|Mean
2594011|NCT02238925|Secondary|Tmax||Induction 1, Day 5||||hours||Full Range|Median
2594012|NCT02238925|Secondary|Complete Response Rate||Following 1st induction, following 2nd induction if applicable|Efficacy population: All subjects who received at least 1 dose of study drug.|||Participants|||Count of Participants
2594013|NCT02238925|Secondary|Serum Copper Levels Change From Baseline|Change from Baseline to Induction 1, Day 5|During 1st induction (up to 5 days)|All subjects who received at least 1 dose of study drug and copper data were collected.|||μg/dL||Standard Deviation|Mean
2594014|NCT02238925|Primary|Effect of CPX-351 on Cardiac Ventricular Repolarization (QTcF)|Time-matched QTcF Changes From Baseline after the start of first infusion|21 days|All subjects who received any dose of study drug and had at least 1 time-matched change from baseline in ECG parameters.|||msecs||Standard Deviation|Mean
2594015|NCT02238847|Post-Hoc|Mortality at One Year After Randomization|The mortality at one year after randomization.|From randomization to one year after randomization||||Participants|||Count of Participants
2594016|NCT02238847|Post-Hoc|Number of Participants With Acute Cholecystitis|The number of participants with acute cholecystitis|From stent placement up to curative intent surgery (CIS) (median 110 days to CIS), or from stent placement up to one year post stent placement for participants not undergoing CIS|43/59 participants in Fully Covered Arm and 42/60 participants in Uncovered Arm had gallbladder in situ. Therefore, Acute Cholecystitis only analyzed in 43 participants in Fully Covered Arm and 42 participants in Uncovered Arm.|||Participants|||Count of Participants
2594017|NCT02238847|Post-Hoc|Number of Participants With Tumor Ingrowth|The number of participants with tumor ingrowth at any point during stent indwell.|Measured at any point during stent indwell - until curative intent surgery (CIS) (median 110 days to CIS) or one year post stent placement (for participants not underoing CIS)||||Participants|||Count of Participants
2594018|NCT02238847|Secondary|For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement|For participants not undergoing curative intent surgery, sustained biliary drainage from stent placement to one year after stent placement.|From stent placement to one year after stent placement for participants not undergoing curative intent surgery|30 participants in the Fully Covered arm did not undergo curative intent surgery and were followed for one year. 32 participants in the Uncovered arm did not undergo curative intent surgery and were followed for one year.|||Participants|||Count of Participants
2594019|NCT02238847|Secondary|Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure|The subjective impression of the surgeon that the presence of a self-expanding metal stent (SEMS) may have impacted the surgical procedure.|At the time of curative intent surgery (CIS) (median 110 days to CIS)|Of 59 Participants in Fully Covered Arm, 24 underwent Curative Intent Surgery. Of 60 Participants in Uncovered Arm, 27 underwent Curative Intent Surgery.|||Participants|||Count of Participants
2594020|NCT02238847|Secondary|Number of Participants With Stent Migration|The number of participants with stent migration|At the time of curative intent surgery (CIS) (median 110 days to CIS) or transition to palliation for participants not underoing CIS||||Participants|||Count of Participants
2594021|NCT02238847|Secondary|Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention|The ability to complete neoadjuvant therapy as intended without stent-related interruptions of neoadjuvant therapy and without biliary reintervention|From initial stent placement procedure to curative intent surgery (CIS) (median 110 days to CIS), or from initial stent placement procedure to one year after initial stent placement for participants not undergoing CIS|Of 59 participants in the Fully Covered arm, neoadjuvant therapy information was only provided for 55 participants. Of 60 participants in the Uncovered arm, neoadjuvant therapy information was only provided for 52 participants.|||Participants|||Count of Participants
2594022|NCT02238847|Secondary|Technical Success|Technical success defined as the ability to deploy the stent in a satisfactory position across the stricture; proximal end of the stent is no more than 1-2cm beyond the proximal end of the stricture.|During the Stent Placement Procedure||||Participants|||Count of Participants
2594023|NCT02238847|Secondary|Procedure-related or Stent-related Serious Adverse Events|Serious adverse events related to the stent placement procedure or to the stent|From stent placement procedure up to one year after stent placement procedure||||Participants|||Count of Participants
2594035|NCT02238483|Secondary|Time to First Moderate or Severe Exacerbation (Where Worsening of COPD Symptoms is Defined as Anthonisens Criteria Fulfilled)||Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||days||Full Range|Median
2596502|NCT02208037|Secondary|Percentage of Participants With Transplant-Related Mortality (TRM)|TRM is defined as death without prior disease relapse or progression.|1 Year Post-transplant||||percentage of participants||90% Confidence Interval|Number
2594024|NCT02238847|Primary|Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms|Sustained biliary drainage, defined as absence of reinterventions for the management of biliary obstructive symptoms, assessed from self-expanding metal stent (SEMS) placement until curative intent surgery (CIS) when applicable, or to one year after SEMS placement otherwise.|From SEMS placement until CIS (for patients undergoing CIS; median 110 days to CIS) or from SEMS placement to one year after SEMS placement (for patients not undergoing CIS)|Participant was eligible for primary endpoint analysis if participant did not undergo biliary reintervention from time of SEMS placement to CIS, or from time of SEMS placement to one year after SEMS placement (for participants not undergoing CIS).|||Participants|||Count of Participants
2594025|NCT02238782|Primary|Absolute Bioavailability|To calculate absolute bioavailability we used the formula: Area Under the Curve (oral dose)/Area Under the Curve (intravenous dose)*100|0 to 72 hours post-dose||||% of bioavailability||90% Confidence Interval|Geometric Mean
2594026|NCT02238483|Secondary|Pulmonary Function Measured as Changes From Baseline (Post-bronchodilator at Visit 3) in Trough FEV1/FVC Ratio||Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|Full Analysis Set excluding one patient due to lack of source data and GCP compliance issues.|||L/L||Standard Deviation|Mean
2594027|NCT02238483|Secondary|Pulmonary Function Measured as Changes From Baseline (Post-bronchodilator at Visit 3) in Trough Forced Vital Capacity (FVC)||Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|Full Analysis Set excluding one patient due to lack of source data and GCP compliance issues.|||Litres||Standard Deviation|Mean
2594028|NCT02238483|Secondary|Pulmonary Function Measured as Changes From Baseline (Post-bronchodilator at Visit 3) in Trough Forced Expiratory Volume in 1 Second (FEV1)||Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|Full Analysis Set excluding one patient due to lack of source data and GCP compliance issues.|||Litres||Standard Deviation|Mean
2594029|NCT02238483|Secondary|Dyspnea (Transitional Dyspnea Index (TDI) Score)|The Baseline/Transitional Dyspnea Index (BDI/TDI) provides a multidimensional measure of dyspnea in relation to activities of daily living. The BDI provides a measure of dyspnoea at a single state, the baseline, and the TDI evaluates changes in dyspnoea from the baseline state. The instrument consists of three components: functional impairment, magnitude of task, and magnitude of effort. For the BDI, each of these three components are rated in five grades from 0 (severe) to 4 (unimpaired), and are summed to form a baseline total score from 0 to 12. For the TDI, changes in dyspnea are rated for each component by seven grades from -3 (major deterioration) to +3 (major improvement), and are added to form a total TDI score from -9 to +9. Positive scores indicate an improvement, and a change from the BDI or a difference between treatments of 1 point has been estimated to constitute the minimum clinically important difference.|Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. Only patients with post-baseline TDI scores were included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
2594030|NCT02238483|Secondary|Health Related Quality of Life (as Assessed by St Georges Respiratory Questionnaire for COPD Patients [SGRQ-C])|The SGRQ-C is a modified version of the St. George's Respiratory Questionnaire, which has been developed to measure the impact of respiratory disease on health status. The SGRQ-C includes 14 questions in 3 domains: symptoms; activity; and impacts. Scores range from 0 to 100 with higher scores indicating benefit. Change in total score from pre study-treatment baseline to Week 12 end of treatment visit are reported.|Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|Full Analysis Set excluding one patient due to lack of source data and GCP compliance issues.|||scores on a scale||Standard Deviation|Mean
2594031|NCT02238483|Secondary|Symptoms of COPD (Using the EXACT for Respiratory Symptoms [E-RS] Total Score, a Subset of Items From the EXACT Diary)|The EXACT for Respiratory Symptoms (E-RS) scale is a derivative instrument comprising a subset of 11 of the EXACT items to evaluate the severity of respiratory symptoms of COPD. Summation of E-RS item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity.|Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||scores on a scale||Standard Error|Least Squares Mean
2594032|NCT02238483|Secondary|Annual Exacerbation Rate of Symptom Defined Exacerbations (as Defined by the EXACT Daily Diary)|"For the production of summary statistics, the annual exacerbation rate per subject is calculated, and standardized per a 52-week period according to the formula described below.~Annual Exacerbation Rate = No. of Exacerbations*365.25 / (Follow-up date - Date of randomization + 1)."|Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||Exacerbations / year||Standard Error|Least Squares Mean
2594033|NCT02238483|Secondary|Time to First Symptom Defined Exacerbation (as Defined by the Exacerbation of Chronic Pulmonary Disease Tool [EXACT] Daily Diary)||Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||days||Full Range|Median
2594034|NCT02238483|Secondary|Annual Exacerbation Rate of Moderate and Severe Exacerbations (Where Worsening of COPD Symptoms is Defined as Anthonisens Criteria Fulfilled)|"For the production of summary statistics, the annual exacerbation rate per subject is calculated, and standardized per a 52-week period according to the formula described below.~Annual Exacerbation Rate = No. of Exacerbations*365.25 / (Follow-up date - Date of randomization + 1)."|Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||Exacerbations / year||Standard Error|Least Squares Mean
2594036|NCT02238483|Secondary|Annual Exacerbation Rate of Moderate and Severe Exacerbations|"For the production of summary statistics, the annual exacerbation rate per subject is calculated, and standardized per a 52-week period according to the formula described below.~Annual Exacerbation Rate = No. of Exacerbations*365.25 / (Follow-up date - Date of randomization + 1)."|Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||Exacerbations / year||Standard Error|Least Squares Mean
2594037|NCT02238483|Secondary|Time to First Moderate or Severe Exacerbation||Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||days||Full Range|Median
2594038|NCT02238483|Secondary|Annual Event Rate of Moderate and Severe COPD Exacerbations and Early Drop-outs (Including Drop-outs Due to Any Cause)|"For the production of summary statistics, the annual event rate per subject is calculated, and standardized per a 52-week period according to the formula described below.~Annual Event Rate = No. of Events*365.25 / (Follow-up date - Date of randomization + 1)."|Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||Events / year||Standard Error|Least Squares Mean
2594039|NCT02238483|Secondary|Time to First Event of Moderate or Severe COPD Exacerbations or Early Drop-out (Including Drop-outs Due to Any Cause)||Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||days||Full Range|Median
2594040|NCT02238483|Secondary|Annual Event Rate of Moderate and Severe COPD Exacerbations and Early Drop-outs Related to Worsening of COPD Symptoms (i.e. Composite Endpoint, ExDo)|"For the production of summary statistics, the annual event rate per subject is calculated, and standardized per a 52-week period according to the formula described below.~Annual Event Rate = No. of Events*365.25 / (Follow-up date - Date of randomization + 1)."|Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||Events / year||Standard Error|Least Squares Mean
2594041|NCT02238483|Primary|Time to First Moderate to Severe COPD Exacerbation or Early Drop-out Related to Worsening of COPD Symptoms||Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)|The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.|||days||Full Range|Median
2594042|NCT02238379|Secondary|Number of Participants Testing Positive for Alcohol Use Following a Breathalyzer|Participants will complete an alcohol breathalyzer to characterize the alcohol use status of the sample.|Within 30 minutes of study visit commencing|1 participant lost to follow-up; data indicates number of participants with alcohol in their system|||Participants|||Count of Participants
2594043|NCT02238379|Secondary|Number of Participants Endorsing Substance Use|The investigators will employ the ASI Lite (McLellan, Luborsky, Woody, & O'Brien, 1980) to assess for current substance use. This measure is included to characterize the sample in respect of substance use; however the ASI Lite did not provide a measure of substance dependance and therefore we report the data from the Mini International Neuropsychiatric Interview substance dependance module (Sheehan et al., 1998) to provide a specific indication of the presence of absence of substance dependance.|Within 30 minutes of study visit commencing|1 participant lost to follow-up; count of participants where substance dependence indicated|||Participants|||Count of Participants
2594044|NCT02238379|Secondary|Early Experience|"The investigators will employ the Parental Bonding Instrument (Parker, Tupling, & Brown, 1979) to assess the early relationship experiences participants have with their caregivers. Existing research employing intranasal oxytocin suggests that the quality of early relationships may impact the strength of any modulation of brain or behavior by oxytocin administration and therefore this variable will be included in the analyses in support of this hypothesis. There are 12 items that capture parental care and 13 items that capture parental overprotection. Items are scored on a 4-point likert scale from very like to very unlike. The PBI is typically scored by identifying optimal (High Care Scores, Low Protection Scores) and less optimal (Low Care Scores, Low Protection Scores) scores on the mother and father subscales (NB: protection refers to overprotection). For the care items, scores can range from 0 to 36; for overprotection items, scores can range from 0 to 39."|Within 20 minutes of study visit commencing|Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss); 1 participant did not know their father and did not complete the measure for paternal assessment|||units on a scale||Standard Deviation|Mean
2594045|NCT02238379|Secondary|Stress|The investigators will measure current levels of stress by using the Perceived Stress Scale (Cohen et al., 1983). It is not yet known the extent to which variation in perceived stress is associated with this methodology, but it is anticipated stress will be associated with levels of depression and anxiety in the sample. The PSS consists of 14 items, with scores ranging from 0 to 42, with higher scores indicating higher levels of perceived stress. A score of 21+ is considered to indicate that participants have higher than average stress.|Within 20 minutes of study visit commencing|Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)|||units on a scale||Standard Deviation|Mean
2594058|NCT02238080|Secondary|Serum IL-6 Level||Baseline, Month 6|ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number analyzed' included participants evaluable for individual categories.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
2594059|NCT02238080|Secondary|Serum CRP Level||Baseline, Month 6|ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number analyzed' included participants evaluable for individual categories.|||milligrams per liter (mg/L)||Standard Deviation|Mean
2594046|NCT02238379|Secondary|Anxiety|The investigators will assess anxiety using the State-Trait Anxiety Inventory (Spielberger et al., 1970). Specifically, it will be explored whether participant anxiety symptoms are associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in anxiety symptoms are associated with this methodology, although prior research has suggested anxiety modulates the neural response to social cues. Scores range from 20-80 and a higher score on both state and trait measures indicate higher levels of anxiety. A potential clinical cut off has been proposed for participants scoring over 39-40 as being high anxious.|Within 20 minutes of study visit commencing|Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)|||units on a scale||Standard Deviation|Mean
2594047|NCT02238379|Secondary|Smoking|Participants will complete a CO breathalyzer and the Fagerstrom Test for Nicotine Dependence (Heatherton, Kozlowski, Frecker, & Fagerstrom, 1991) to assess smoking behavior. These measures are included to characterize the sample in respect of substance use.|Within 30 minutes of study visit commencing|1 participant was lost to follow-up|||Participants|||Count of Participants
2594048|NCT02238379|Secondary|Depression|The investigators will assess depression by employing the Beck Depression Inventory (Beck et al., 1961). Specifically addressing whether the level of depression symptomatology in participants and whether this is associated with the neural correlates of social and non-social perception during both intervention and placebo visits. It is not yet known the extent to which variation in depression symptoms are associated with this methodology, although prior research has suggested depression modulates the neural response to social cues. This measure includes a question regarding suicidal ideation and therefore it is acknowledged there may be a safety issue in response to the questionnaire. Scores range from 0-63, with higher scores indicating greater levels of depression (scores 29+ indicates severe depression).|Within 20 minutes of study visit commencing|Only participants included that have ERP data to analyze (excluding participant lost to follow-up and data loss)|||units on a scale||Standard Deviation|Mean
2594049|NCT02238379|Primary|Latency Non-Social|The investigators will analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo on ERP latency measures in the non-social condition.|Duration of 30 minutes|1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); 2 participants were statistical outliers and removed from oxytocin and placebo arms for N170 latency analysis|||milliseconds||Standard Deviation|Mean
2594050|NCT02238379|Primary|Latency Social|The investigators analyze the latency (i.e., efficiency of processing) of visually elicited ERP components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be more efficient processing (i.e., earlier latency) of ERPs during the social condition following administration of the intervention relative to the placebo condition.|Duration of 30 minutes|1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); for LPP analysis, 1 participants were statistical outliers and removed from oxytocin and placebo arms for N170 latency analysis|||milliseconds||Standard Deviation|Mean
2594051|NCT02238379|Primary|Amplitude Non-Social|The investigators analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the non-social stimuli (houses). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that there will be no difference between the intervention and placebo during the non-social condition on the amplitude of the ERPs.|Duration of 30 minutes|1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms)|||microvolts||Standard Deviation|Mean
2594052|NCT02238379|Primary|Amplitude Social|The investigators will analyze the amplitude (i.e., size) of visually elicited event-related potential (ERP) components to the social stimuli (infant and adult faces). This assessment will be completed after administration of the intervention (oxytocin) and the placebo to compare the neural response. The investigators hypothesize that the intervention will modulate the amplitude of the neural response to social stimuli given its previously identified role in social interactions, most likely increasing the size of the ERPs.|Duration of 30 minutes|1 participant was lost to follow-up (did not complete placebo); 1 participant's data was lost (removed then from placebo and oxytocin arms); for LPP analysis, 1 participant was a statistical outlier and removed from oxytocin and placebo arms|||microvolts||Standard Deviation|Mean
2594053|NCT02238080|Secondary|Serum Hemoglobin Level||Baseline, Month 6|ITT population. 'Number analyzed' included participants evaluable for individual categories.|||grams per deciliter (g/dL)||Standard Deviation|Mean
2594054|NCT02238080|Secondary|Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose||Day 1|As per change in planned analysis, this outcome was removed due to small sample size and no data was collected for this outcome.||||||
2594055|NCT02238080|Secondary|Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose||Day 1|As per change in planned analysis, this outcome was removed due to small sample size and no data was collected for this outcome.||||||
2594056|NCT02238080|Secondary|Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6|Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).|Month 6|ITT population. Participants with stable maintenance treatment were included in this analysis. ‘Number of participants analyzed’ (N) included participants evaluable for this outcome measure.|||correlation coefficient|||Number
2594057|NCT02238080|Secondary|Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6|Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).|Month 6|ITT population. Participants with stable maintenance treatment were included in this analysis. ‘Number of participants analyzed’ (N) included participants evaluable for this outcome measure.|||correlation coefficient|||Number
2594060|NCT02238080|Secondary|Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6||Baseline, Month 6|ITT population. Participants with stable maintenance treatment were included in this analysis. ‘Number of participants analyzed’ (N) included participants evaluable for this outcome measure. 'Number analyzed' included participants evaluable for individual categories.|||mcg/kg||Standard Deviation|Mean
2594061|NCT02238080|Secondary|Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6|Percentage of participants with change in methoxy polyethylene glycol-epoetin beta dose compared to baseline were reported as per the following categories: (a) No change, (b) Dose increase (1 to greater than [>] 200 micrograms per kilogram [mcg/kg]), and (c) Dose decrease (1 to >200 mcg/kg).|Month 6|ITT population. Participants with stable maintenance treatment were included in this analysis.|||percentage of participants|||Number
2594062|NCT02238080|Primary|Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose|Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).|Day 1|ITT population. Participants with stable maintenance treatment were included in this analysis. ‘Number of participants analyzed’ (N) included participants evaluable for this outcome measure.|||correlation coefficient|||Number
2594063|NCT02238080|Primary|Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose|Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).|Day 1|ITT population. Participants with stable maintenance treatment were included in this analysis. ‘Number of participants analyzed’ (N) included participants evaluable for this outcome measure.|||correlation coefficient|||Number
2594064|NCT02238067|Secondary|Percentage of Participants by Injection Site Pain by ESA Type|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their injection site pain on a 1-5 scale, where 1 represents 'Not painful' and 5 represents 'Very painful'. Percentage of participants with each score and ESA type was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.|||percentage of participants|||Number
2594065|NCT02238067|Secondary|Percentage of Participants by Injection Site Pain|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their injection site pain on a 1-5 scale, where 1 represents 'Not painful' and 5 represents 'Very painful'. Percentage of participants with each score was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.|||percentage of participants||95% Confidence Interval|Number
2594066|NCT02238067|Secondary|Percentage of Participants by Convenience of Syringe Usage by ESA Type|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their convenience of syringe usage on a 1-5 scale, where 1 represents 'Inconvenient' and 5 represents 'Very convenient'. Percentage of participants with each score and ESA type was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.|||percentage of participants|||Number
2594067|NCT02238067|Secondary|Percentage of Participants by Convenience of Syringe Usage|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their convenience of syringe usage on a 1-5 scale, where 1 represents 'Inconvenient' and 5 represents 'Very convenient'. Percentage of participants with each score was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.|||percentage of participants||95% Confidence Interval|Number
2594068|NCT02238067|Secondary|Percentage of Participants by Limitation of Daily Life Due to ESA Refrigeration Requirements by ESA Types|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their limitation of daily life due to ESA refrigeration requirements on a 1-5 scale, where 1 represents 'Does not limit' and 5 represents 'significantly limits'. Percentage of participants with each score and ESA type was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.|||percentage of participants|||Number
2594069|NCT02238067|Secondary|Percentage of Participants by Limitation of Daily Life Due to ESA Refrigeration Requirements|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their limitation of daily life due to ESA refrigeration requirements on a 1-5 scale, where 1 represents 'Does not limit' and 5 represents 'significantly limits'. Percentage of participants with each score was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.|||percentage of participants||95% Confidence Interval|Number
2594070|NCT02238067|Secondary|Percentage of Participants by Preferred Treatment Frequency by Baseline ESA Frequency|"Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for their preference of treatment frequency and baseline ESA frequency. Participants were asked Assuming that there are several options for anemia treatment with the only difference being the frequency of use, what is your preference?. Preferred treatment frequency included: once a month (O/M), twice a month (B/M), once a week (O/W), twice a week (B/W), three times a week (T/W) or other (any other frequency]). Frequency of baseline ESA use included: three times a week, twice a week, once a week, every 2 weeks (Q2W), every 4 weeks (Q4W) or other (any other frequency). Percentage of participants by each preferred treatment frequency and baseline ESA frequency was reported."|Baseline, Month 6|All enrolled participants. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable for specified categories.|||percentage of participants|||Number
2594082|NCT02238067|Primary|Percentage of Participants by ESA Types at Month 6|Assessment was performed by physician via a satisfaction survey on anemia treatment. ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type was reported.|Month 6|All enrolled participants who completed the questionnaire at Month 6|||percentage of participants||95% Confidence Interval|Number
2594366|NCT02233738|Secondary|Addiction Severity Index-Lite (ASI-Lite) at 6 Months for Psychiatric Status|The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity|6 months||||score on a scale||Standard Deviation|Mean
2594071|NCT02238067|Secondary|Percentage of Participants by Preferred Treatment Frequency by ESA Type|"Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and their preference of treatment frequency. Participants were asked Assuming that there are several options for anemia treatment with the only difference being the frequency of use, what is your preference?. Participants answered as either once a month, twice a month, once a week, twice a week, three times a week or other (any other frequency). Percentage of participants with each preferred treatment frequency and ESA type was reported."|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.|||percentage of participants|||Number
2594072|NCT02238067|Secondary|Percentage of Participants by Preferred Treatment Frequency|"Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked Assuming that there are several options for anemia treatment with the only difference being the frequency of use, what is your preference?. Participants answered as either once a month, twice a month, once a week, twice a week, three times a week or other (any other frequency). Percentage of participants with each preferred treatment frequency was reported."|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.|||percentage of participants||95% Confidence Interval|Number
2594073|NCT02238067|Secondary|Percentage of Participants by Need for Improvement in Treatment Frequency by ESA Type|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked for the type of ESA received (Mircera, Recormon, Eprex or Aranesp) and to rate their need for improvement in the frequency of each treatment received currently on a 1-5 scale, where 1 represents 'Convenient, there is no need for improvement' and 5 represents 'improvement is very necessary'. Percentage of participants with each score and ESA type was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable for specified categories.|||percentage of participants|||Number
2594074|NCT02238067|Secondary|Percentage of Participants by Need for Improvement in Treatment Frequency|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked to rate their need for improvement in the frequency of treatment received currently on a 1-5 scale, where 1 represents 'Convenient, there is no need for improvement' and 5 represents 'Improvement is very necessary'. Percentage of participants with each score was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.|||percentage of participants||95% Confidence Interval|Number
2594075|NCT02238067|Secondary|Percentage of Participants With Interest in Learning to Inject Independently|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants responded 'yes' or 'no' to the question: 'Would you be interested in learning to inject independently?' ' Percentage of participants who responded 'yes', was reported.|Baseline, Month 6|All enrolled participants who did not inject independently. Here ‘n’ signifies number of participants evaluable at specified time-points.|||percentage of participants||95% Confidence Interval|Number
2594076|NCT02238067|Secondary|Percentage of Participants by Different Injection Administration Modes|Assessment was performed by physician via a satisfaction survey on anemia treatment. Participants were asked: 'How do you currently inject the anemia treatment?' and reported any of the 5 possible answers: Independently, by a family member, nurse at home, nurse at the clinic or other. Percentage of participants with each injection administration modes was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.|||percentage of participants|||Number
2594077|NCT02238067|Secondary|Percentage of Participants by Different CKD Stages|Assessment was performed by physician via a satisfaction survey on anemia treatment. CKD stages were based on participant's answer to the survey question. No specific method of assessment for CKD stage was specified. Percentage of participants with each CKD stage was reported.|Baseline, Month 6|All enrolled participants. Here ‘n’ signifies number of participants evaluable at specified time-points.|||percentage of participants|||Number
2594078|NCT02238067|Primary|Percentage of Participants by Frequency and Types of ESA Used at Month 6|Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type and each frequency of ESA use was reported.|Month 6|All enrolled participants who completed the questionnaire at Month 6. Here 'n' signifies number of participants evaluable for specified categories.|||percentage of participants|||Number
2594079|NCT02238067|Primary|Percentage of Participants by Frequency and Types of ESA Used at Baseline|Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type and each frequency of ESA use was reported.|Baseline|All enrolled participants. Number of participants analyzed = participants evaluable for this outcome measure. Here ‘n’ signifies number of participants evaluable for specified categories.|||percentage of participants|||Number
2594080|NCT02238067|Primary|Percentage of Participants by Frequency of ESA Use at Month 6|Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). Percentage of participants by each frequency of ESA use was reported.|Month 6|All enrolled participants who completed the questionnaire at Month 6|||percentage of participants||95% Confidence Interval|Number
2594081|NCT02238067|Primary|Percentage of Participants by Frequency of ESA Use at Baseline|Assessment was performed by physician via a satisfaction survey on anemia treatment. Frequency of ESA use included:Three times a week, twice a week, once a week, every 2 weeks, every 4 weeks or other (any other frequency). Percentage of participants by each frequency of ESA use was reported.|Baseline|All enrolled participants. Number of participants analyzed = participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2594083|NCT02238067|Primary|Percentage of Participants by ESA Types at Baseline|Assessment was performed by physician via a satisfaction survey on anemia treatment. ESA types included: Mircera, Recormon, Eprex, and Aranesp. Percentage of participants with each ESA type was reported.|Baseline|All enrolled participants|||percentage of participants||95% Confidence Interval|Number
2594084|NCT02238028|Primary|Circulating Biomarkers——ET-1|At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Endothelin-1(ET-1) was using enzyme-linked immunosorbent assays.|Up to 24 hours||||pg/ml||Standard Deviation|Geometric Mean
2594085|NCT02238028|Primary|Circulating Biomarkers——P- Selectin,VCAM-1|At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. P- selectin,VCAM-1(vascular cell adhesion molecule-1) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts)|Up to 24 hours||||ng/ml||Standard Deviation|Geometric Mean
2594086|NCT02238028|Primary|Circulating Biomarkers——Fibrinogen，vWF|At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Fibrinogen and von Willebrand factor(vWF) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts)|Up to 24 hours||||µg/ml||Standard Deviation|Geometric Mean
2594087|NCT02238028|Primary|Heart Rate Variability—pNN50|HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the proportion of successive normal NN intervals differing by more than 50 ms in the total number of NNs（pNN50） were automatically recorded during the intervention.|Up to 24 hours||||percentage of ms||Standard Deviation|Geometric Mean
2594088|NCT02238028|Primary|Heart Rate Variability—LF/HF|HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences.|Up to 24 hours||||ratio||Standard Deviation|Geometric Mean
2594089|NCT02238028|Primary|Heart Rate Variability-SDNN,SDANN, rMSSD|HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the standard deviation of the normal-to-normal interval(SDNN),the standard deviation of the average NN intervals calculated over short periods(SDANN), the root mean square of the successive differences(rMSSD) were automatically recorded during the intervention.|Up to 24 hours||||ms||Standard Deviation|Geometric Mean
2594090|NCT02238028|Primary|Blood Pressure|The blood pressure were measured by automatic blood pressure monitor during the intervention study.|up to 24 hours||||mmHg||Standard Deviation|Mean
2594091|NCT02238028|Primary|Heart Rate Variability-LF Power,HF Power,VLF Power|HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz, and the very low frequency (VLF) from 0.0033 to 0.04 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences.|up to 24 hours||||ms^2||Standard Deviation|Geometric Mean
2594092|NCT02237950|Secondary|Adverse Events (AEs)|Number of participants with genitourinary AEs considered potentially related to study treatment|From Baseline to end of Week 28|Safety population was all patients in the Intent-to-Treat population, but excluding those who later returned all the study medication unused.|||Participants|||Count of Participants
2594093|NCT02237950|Secondary|Change From Baseline in Brief Index of Sexual Functioning for Women Questionnaire Composite Score|Change from baseline in brief index of sexual functioning for women (BISF-W) questionnaire composite score. The composite score includes scores from dimensions (D) of thoughts/desire (D1, 0-12), arousal (D2, 0-12), frequency of sexual activity (D3, 0-12), receptivity/initiation (D4, 0-12), pleasure (D5, 0-12), relationship satisfaction (D6, 0-12), and any problems affecting sexual functioning (D7, 0-16). The composite score is calculated as D1+D2+D3+D4+D5+D6-D7 with a range of -16 to +75. A positive change in composite score from baseline to Week 16 reflects an improvement in sexual functioning, with a greater change in score indicating a greater improvement in sexual functioning.|Baseline to Week 16|Analysis population includes only those participants who completed the survey, which was optional.|||change in score on a scale||95% Confidence Interval|Mean
2594094|NCT02237950|Secondary|Recurrence of BV According to the Composite Definition of at Least 3 Clinical Findings (Amsel Criteria) and a Nugent Score of 4-10.|Number of participants with a recurrence of BV according to the composite definition of at least 3 clinical findings (Amsel criteria) and a Nugent score of 4-10 (intermediate to BV), where 0-3 is normal.|At or by the Week 16 visit|Modified Intent-to-Treat, excluding patients with missing values.|||Participants|||Count of Participants
2605763|NCT02107014|Primary|Change in IL-1β From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2594095|NCT02237950|Secondary|Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings|Number of participants with a recurrence of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)|At or by the Week 24 visit|Analysis population is the modified intent-to-treat analysis population. One patient was excluded compared with the intent-to-treat population because they were dispensed medication but returned all unused.|||Participants|||Count of Participants
2594096|NCT02237950|Secondary|Recurrence of BV as Determined by Presence of a Nugent Score of 7-10|Number of participants with a recurrence of BV as determined by presence of a Nugent score of 7-10 (BV), where 0-3 is normal, and 4-6 is intermediate.|At or by the Week 16 visit|Modified Intent-to-Treat, excluding patients with missing values.|||Participants|||Count of Participants
2594097|NCT02237950|Secondary|Recurrence of Individual Amsel Criteria|"Number of participants with positive individual Amsel criterion~- Clue cells representing at least 20% of total epithelial cells"|At or by the Week 16 visit|Modified Intent-to-Treat, excluding patients with missing values.|||Participants|||Count of Participants
2594098|NCT02237950|Secondary|Recurrence of Patient-reported BV Symptoms|Number of participants with self-reported BV symptoms (vaginal discharge and/or odor)|At or by the Week 16 visit|Modified Intent-to-Treat, excluding patients with missing values.|||Participants|||Count of Participants
2594099|NCT02237950|Secondary|Time to Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings|Time to recurrence of BV (days), where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)|At or by the Week 16 visit|Analysis population is the modified intent-to-treat analysis population. One patient was excluded compared with the intent-to-treat population because they were dispensed medication but returned all unused.|||days||95% Confidence Interval|Median
2594100|NCT02237950|Primary|Recurrence of BV Where a Diagnosis of BV is Defined as the Presence of at Least 3 Clinical Findings|Number of participants with a recurrence of BV, where a diagnosis of BV is defined as the presence of at least 3 clinical findings (Amsel criteria)|At or by the Week 16 visit|Analysis population is the modified intent-to-treat analysis population. One patient was excluded compared with the intent-to-treat population because they were dispensed medication but returned all unused.|||Participants|||Count of Participants
2594101|NCT02237911|Other Pre-specified|Physical Activity Energy Expenditure - Measured by Portable Activity Monitor (SenseWear).|Real-time measure of daily energy expenditure physical activity assessed by portable activity monitor.|Baseline, 3 and 6 months|Intention-to-treat approach was used among participants with follow-up data.|||Kcal/day||Standard Deviation|Mean
2594102|NCT02237911|Secondary|Composite Score of Performed-based Tests of Physical Function.|Scores on 6 performance-based tests (i.e., the 6-minute walk test, 40-meter gait speed, stair ascend/descend test, single leg stance balance test, chair stand test, and floor sitting-rising) were combined into a composite score formed with the unit-weighted Z scores of constituent tests to provide a more representative and stable measure of the subjects' underlying functional performance. The unit weights refer to averaging standardized scores (e.g., the scores for each performance-based test are converted to Z-scores before applying equal weights). Higher Z-scores represent better functional performance. The Z-scores for each participant can be interpreted as deviations from the baseline average of the whole group. We considered a change in Z-score of 0.2 as clinically important because it represents approximately 20% of a standard deviation relative to the baseline average of the whole group.|Baseline, 3 and 6 months|Intention-to-treat approach was used among participants with follow-up data.|||Z-score||Standard Deviation|Mean
2594103|NCT02237911|Primary|The Western Ontario and McMaster Universities Osteoarthritis Index Physical Function (WOMAC-PF).|WOMAC-PF is a patient reported outcome with 17 items. Each item is scored on a 5-point Likert-type Scale with descriptors from 0-4 (none, mild, moderate, severe, and extreme difficulty) and summed for a maximum score of 68. Higher scores indicate worse physical function.|Baseline, 3 and 6 months|Intention-to-treat approach was used among participants with follow-up data.|||units on a scale||Standard Deviation|Mean
2594104|NCT02237118|Secondary|Assessment of the Surrounding Skin.|assessment of the surrounding skin.|21 days||||percentage of patients|||Number
2594105|NCT02237118|Secondary|Safety|Adverse Event, Adverse Device Event|21 days||||Participants|||Count of Participants
2594106|NCT02237118|Secondary|Condition of the Wound, Will be Assesst by the Investigator.|wound size estimation, assesstemnt of the wound,|21 days|Missing value for some patients|||Participants|||Count of Participants
2594107|NCT02237118|Secondary|Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System.|Complete healing at day 21, will be measured using PictZar system.|21 days||||percentage of wound size reduction||Standard Deviation|Mean
2594108|NCT02237118|Primary|Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS)|To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul®, during the first dressing removal. Pain measured by VAS Score ≥ 30 mm on the 100 mm VAS scale are reported.|21 days|intention to treat.Participants with None painfull dressing removal.|||participants|||Number
2594109|NCT02237092|Secondary|Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg||After spinal anesthesia, average 20 minutes.||||Number of pregnants with Blocks = > Th4|||Number
2594110|NCT02237092|Secondary|The Level of IAP|The level of IAP in obstetric patients in the groups with high ( => Th4) and low (< = Th5) blocks|After spinal anesthesia, average 20 minutes.||||mm Hg||Standard Error|Median
2594111|NCT02237092|Primary|Obesity and IAP|Effect of obesity on the level of IAP|Before spinal anesthesia, average 10 minutes.||||mm Hg||Standard Error|Median
2594112|NCT02237092|Secondary|Level of Sensory Blocks|Block level of thoracic vertebrae are reported for pregnant women who had level of sensory block higher than 4 thoracic vertebra and less than 5 thoracic vertebra|After spinal anesthesia, average 20 minutes.||||Block level level of thoracic vertebrae||Standard Error|Median
2594113|NCT02237092|Primary|Classification Grade of Intra-abdominal Hypertension (IAH)|Average IAP in pregnant women with different Grade of intra-abdominal hypertension Physiological norm (≤11,99 mm Hg) Grade I (12 - 15.99 mm Hg) Grade II (16 - 20.99 mm Hg) Grade III (21 - 25.99 mm Hg)|Before spinal anesthesia, average 10 minutes.||||mm Hg||Standard Error|Median
2594217|NCT02234752|Secondary|Kynurenine (KYN)|The secondary outcome measure will be change in metabolite values. Values were collected in triplicate.|Baseline and 6-Weeks|Participant 3 only provided baseline data|||µM||Standard Deviation|Mean
2594114|NCT02237092|Primary|The Level of Intra-abdominal Pressure (IAP)|Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, after quiet breathing pregnant at the time of expiration. The data obtained are in inches of water column were translated in millimeters of mercury.|Before spinal anesthesia, average 10 minutes.||||mm Hg||Standard Error|Median
2594115|NCT02236767|Primary|The Saving Inventory-Revised (SI-R) Total Score|The Saving Inventory-Revised (SI-R) is a self-report measure which includes 23 items assessing the severity of hoarding symptoms including difficulty discarding, acquiring, and clutter. The 23 items are added for a total score which ranges from 0 to 92 and with higher score indicating more severe hoarding symptoms.|Pre-baseline, Post-baseline/Pre-treatment, Post-treatment, 2-Month Follow-up||||units on a scale|||Number
2594116|NCT02236611|Primary|Change From Baseline in Trough FEV1 on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes (min) pre-dose on Day 1. Change from baseline was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis performed using a repeated measures model with covariates of treatment, baseline FEV1, centre group, 24 hour subset flag, Day, Day by baseline and Day by treatment interactions. The least squares mean changes are presented here.|Baseline (BL) and Day 85|Per Protocol(PP) Population(pop): Participants(par) in the Intent-To-Treat pop who did not have a full protocol deviation considered to impact efficacy. Par represent those with data available at time point presented; however, all par. in the PP pop. without missing covariate information and >=1 post BL measurement are included in analysis|||Liter||Standard Error|Least Squares Mean
2594117|NCT02236598|Secondary|Changes in Insulin Sensitivity|Matsuda Insulin Sensitivity Index was calculated as: 10,000 / square root of [fasting glucose x fasting insulin x mean glucose x mean insulin during Oral Glucose Tolerance Test]).|Baseline to 3 months||||AUC - unitless,||Standard Deviation|Mean
2594118|NCT02236598|Secondary|Changes in Insulin Secretion as Measured by 2-hour Insulin Area-under-the-curve (AUC)|Changes in Insulin Secretion as measured by 2-hour insulin area-under-the-curve (AUC - measured via the trapezoidal method) of 2 hours from the 3-hour OGTT.|Baseline to 3 months||||AUC - pg*min/mL||Standard Deviation|Mean
2594119|NCT02236598|Secondary|Changes in Fasting, 1-hour, and 2-hour Post-challenge Glucose Levels in mg/dL|Changes in fasting, 1-hour, and 2-hour post-challenge glucose levels in mg/dL|Baseline to 3 months||||mg/dL||Standard Deviation|Mean
2594120|NCT02236598|Primary|Change in Glucose Tolerance as Measured by Area-under-the-curve|Change in glucose tolerance, as measured by change in glucose area-under-the-curve (Area Under the Curve (AUC) - measured via the trapezoidal method) of 2 hours from the 3-hour Oral Glucose Tolerance Test (OGTT).|Baseline to 3 months||||AUC - mg*min/dL||Standard Deviation|Mean
2594121|NCT02236559|Secondary|Length of Stay|Evaluate the capability of HVNI, compared to NIPPV, to affect average length of stay.|Duration of hospital visit||||days||Standard Deviation|Mean
2594122|NCT02236559|Secondary|Ventilatory Indices 9|"Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (base excess), a measure of blood oxygen/CO2 levels, recorded at one and four hours, and at treatment failure if applicable.~NOTE: Due to test error, the number analyzed is less than the total patients in the trial."|At one and four hours|If treatment failed prior to followup recording, subsequent data was not collected per the protocol.|||mmol/L||Standard Deviation|Mean
2594123|NCT02236559|Secondary|Ventilatory Indices 8|"Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (HCO3), a meausre of blood oxygen/CO2 levels, recorded at one and four hours, and at treatment failure if applicable.~NOTE: Due to test error, the number analyzed is less than the total patients in the trial."|At one and four hours|If treatment failed prior to followup recording, subsequent data was not collected per the protocol.|||mEq/L||Standard Deviation|Mean
2594124|NCT02236559|Secondary|Ventilatory Indices 7|"Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (PCO2), a measure of CO2, recorded at one and four hours, and at treatment failure if applicable.~NOTE: Due to test error, the number analyzed is less than the total patients in the trial."|At one and four hours|If treatment failed prior to followup recording, subsequent data was not collected per the protocol.|||mmHg||Standard Deviation|Mean
2594125|NCT02236559|Secondary|Ventilatory Indices 6|"Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Blood gas (pH), a measurement of CO2 levels, recorded at one and four hours, and at treatment failure if applicable.~NOTE: Due to test error, the number analyzed is less than the total patients in the trial."|At one and four hours|If treatment failed prior to followup recording, subsequent data was not collected per the protocol.|||pH||Standard Deviation|Mean
2594126|NCT02236559|Secondary|Ventilatory Indices 5|"Evaluate the capability of HVNI, compared to NIPPV, to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Modified Borg score recorded at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable). NOTE: Due to the need for patients to be alert and able to provide this score, the number analyzed is less than the total patients in the trial.~A modified Borg scale was used to ask the patient to describe their effort on a scale of 0 to 10, where 10 is extreme discomfort."|at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable)|If treatment failed prior to followup recording, subsequent data was not collected per the protocol. Some participants were unable to give scores due to health status.|||score on a scale||Standard Deviation|Mean
2594127|NCT02236559|Secondary|Ventilatory Indices 4|"Evaluate the capability of HFT, compared to NIPPV, to affect indices of ventilation. Patient discomfort as rated on a VAS recorded at one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).. NOTE: Due to need for patients to be alert and provide this rating, the number analyzed is less than the total patients in the trial.~VAS: Visual Analogue Scale. A Likert scale of facial expressions ranging from a smiley face to a frowning face used to assess the subjects' subjective level of dyspnea. Minimum 0 (no discomfort) to Maximum 5 (maximum discomfort)."|At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).|If treatment failed prior to followup recording, subsequent data was not collected per the protocol. Some participants were unable to give scores due to health status.|||score on a scale||Standard Deviation|Mean
2594128|NCT02236559|Secondary|Ventilatory Indices 3|Evaluate the capability of high velocity nasal insufflation (HVNI), compared to non-invasive positive pressure ventilation (NIPPV), to affect indices of ventilation. The secondary endpoint is the degree of improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. SpO2 (a measurement of blood oxygen) recorded at baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).|At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).|If treatment failed prior to followup recording, subsequent data was not collected per the protocol.|||% SpO2||Standard Deviation|Mean
2594129|NCT02236559|Secondary|Ventilatory Indices 2|Evaluate the capability of high velocity nasal insufflation (HVNI), compared to non-invasive positive pressure ventilation (NIPPV), to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia. Respiratory rate recorded at one and four hours, and at treatment failure if applicable.|At baseline, 30 minutes, 60 minutes, 90 minutes, 4 hours, and treatment failure if applicable|If treatment failed prior to followup recording, subsequent data was not collected per the protocol.|||breaths per min||Standard Deviation|Mean
2594130|NCT02236559|Secondary|Ventilatory Indices 1|Evaluate the capability of high velocity nasal insufflation (HVNI), compared to non-invasive positive pressure ventialtion (NIPPV), to affect indices of ventilation. The secondary endpoint is the degree of physiologic improvement in blood oxygen and CO2 levels that signify a reduction in both hypoxemia and/or hypercapnia.|At one and four hours baseline, 30min, 1 hr, 90 min, and 4 hrs (if still on therapy) and at treatment failure/intubation (if applicable).|If treatment failed prior to followup recording, subsequent data was not collected per the protocol.|||beats per min||Standard Deviation|Mean
2594131|NCT02236559|Primary|Treatment Failure Rate|Determine the efficacy of HFT compared to NIPPV in treating respiratory failure. The primary endpoint will be treatment failure within 72 hrs as determined by intubation.|Within 72 hrs||||Participants|||Count of Participants
2594132|NCT02236546|Secondary|Changes in Tumor [18F]Fluorodeoxyglucose (FDG) Accumulation|The association between the changes in tumor FDG accumulation with a panel of immunohistochemical biomarkers will be assessed with the Spearman correlation statistic. 95% confidence intervals will be calculated for each variable. Paired changes in biomarker expression between biopsied (i.e., baseline) and biopsy samples will be compared using the nonparametric Wilcoxon signed rank test. Change in binary expression will be compared using McNemar's test. The Wilcoxon rank sum test (or Kruskal Wallis test for more than 2 groups) will be used to compare continuous and ordinal variables.|Baseline to day 21|Due to loss of funding data were not collected||||||
2594133|NCT02236546|Secondary|Progression-free Survival (PFS)|Cox (proportional hazards) regression will be used to assess the association between the percent change in average standardized FDG uptake and PFS.|Time from first treatment until objective tumor progression or death for any reason, assessed up to 7 years|Due to loss of funding data were not collected||||||
2594134|NCT02236546|Secondary|Objective Response (OR)|The ability of the percent change in average standardized FDG uptake to predict OR will be assessed using the proportional odds model.|Day 84|Due to loss of funding data were not collected||||||
2594135|NCT02236546|Primary|Percent Change in the Sum of the Longest Dimension of Target Lesions, Defined by RECIST|The primary imaging metric is percent change in average FDG standardized uptake value (SUV) among the same target lesions between baseline and images acquired after completion of cycle 1. The relationship between tumor SUV change and size change will be assessed using standard linear regression.|Baseline to the completion of 6 courses of treatment|Due to loss of funding data were not collected||||||
2594136|NCT02236520|Primary|Change in Tissue Sodium Concentration Measured Using Sodium Magnetic Resonance Imaging (NaMRI)|NaMRI is a sensitive laboratory assessment of the concentration of sodium in tissue|baseline and 8 weeks||||mmol/L||Inter-Quartile Range|Median
2594137|NCT02236338|Other Pre-specified|Incidence of Objective Post-procedure Bruising|Measured with bruising scale, with a range of 1-10 with 10 being the most bruising.|During post procedure recovery period in clinic, an expected average of 2 hours after surgery.||||units on a scale||Full Range|Median
2594138|NCT02236338|Other Pre-specified|Incidence of Post-procedure Pain|Measured with Visual Analog Scale (VAS), with a range of 1-10 with 10 being the most pain.|During post procedure recovery period in clinic, an expected average of 2 hours after surgery.||||units on a scale||Full Range|Median
2594139|NCT02236338|Secondary|Incidence Rate of Acute Complications|Number of acute complications at one and 6 weeks post intervention|up to 6 weeks post intervention||||number of complications|||Number
2594140|NCT02236338|Primary|Percentage of Participants Without Recurrent Clinical Symptoms of an Incompetent Greater Saphenous Vein After Treatment.||Annual follow up, up to 75 months|The mean long-term followup in the EVLA group was 44 (12–64) months, and the mean long-term follow-up in the RFA group was 42 (12–75) months.|||percentage of total participants|||Number
2594141|NCT02236130|Secondary|Patient/Family Satisfaction With Pain Management|Patient/family satisfaction on a scale of 1 to 10 with 1 least satisfied and 10 completely satisfied. Family will complete the form and return to the primary investigator at the end of day 8 after surgery in the prepaid envelope provided to them at the time of the surgery.|one week after the surgery||||Participants|||Count of Participants
2594142|NCT02236130|Primary|Total Hydrocodone Dose (mg/kg)||day 2 and day 8 after the surgery||||mg/kg||Standard Deviation|Mean
2594143|NCT02235987|Primary|Participants With Trough Human Growth Hormone < 2.5 ug/mL||Pre dose and 0.33, 0.67 hours and 1, 1.5, 2, 3, 4, 5, 6 and 8 hours post dose on each dosing day.|Baseline: an 8 hour untreated human growth hormone (hGH) profile was obtained in the period between 15 and 7 days prior to the first study treatment administration.|||participants with trough hGH < 2.5 µg/mL|||Number
2594144|NCT02235870|Other Pre-specified|Percentage of Subjects With at Least 5% Total Body Loss: Obalon - Sham Group|Difference in percentage of subjects between the Obalon Treatment and Sham Control groups with at least 5% Total Body Loss (TBL)|6 Months|Per Protocol cohort which includes subjects with at least 2 devices for at least 18 weeks|||Participants|||Count of Participants
2594145|NCT02235870|Primary|Percentage of Subjects in the Obalon Treatment Group With at Least 5% Total Body Loss (TBL)|Statistical test to determine if the percentage of subjects in the Obalon Treatment and Sham Control with at least 5% Total Body Loss (TBL) is greater than 35%|6 months|Per Protocol cohort which includes subjects in the Obalon Treatment group with at least 2 balloons for at least 18 weeks|||Participants|||Count of Participants
2594146|NCT02235870|Primary|Least-Square Mean Difference in % Total Body Loss (TBL) Between the Obalon Treatment and Sham Control Groups|Statistical test to determine if the least-square mean difference between the Obalon Treatment and Sham Control groups is greater than the 2.1% TBL superiority margin|24 Weeks|Per Protocol cohort which includes subjects with at least 2 devices for at least 18 weeks|||%TBL||Standard Error|Least Squares Mean
2594147|NCT02235831|Primary|Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance|Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.|Day 5, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria, as specified in the Deviations and Evaluability Plan (DEP).|||diopter*logMar|||Number
2594148|NCT02235493|Secondary|Performance-Oriented Mobility Assessment-Gait Subtest (POMA-G) - Change From Baseline to Last Overall|The POMA-G is a 7-component assessment that is used to evaluate gait performance. The second component has 4 sub-components. Scores of 0, 1 or 2 are assigned to 2 components while scores of 0 or 1 are assigned to the rest of the 4 components and 4 sub-components based on type of ambulation pattern observed. The maximum total score of 12 points = no impairment and 0 points = worst impairment.|The earliest available MPOMA-G score that was assessed within the period of patients' aged 5 to 15 years, inclusive.||||units on a scale||Inter-Quartile Range|Median
2594149|NCT02235493|Primary|Modified Performance-Oriented Mobility Assessment-Gait Subtest (MPOMA-G) - Change From Baseline to Last Overall|The MPOMA-G is a 5-component assessment that is used to evaluate gait performance. The first component has 4 sub-components. For 2 components and 2 sub-components, scores of 0 or 1 are assigned while scores of 0, 1 or 2 are assigned to the rest of the 2 components and 2 sub-components based on type of ambulation pattern observed. The maximum total score of 12 points = no impairment and 0 points = worst impairment.|The earliest available MPOMA-G score that was assessed within the period of patients' aged 5 to 15 years, inclusive.||||units on a scale||Inter-Quartile Range|Median
2594150|NCT02235454|Primary|Retinal Nerve Fiber Layer (RNFL) Thickness Correlation Width Global Bruch's Membrane Opening-minimum Rim Width (BMO-MRW)|Pearson correlation coefficient between Retinal Nerve Fiber Layer (RNFL) thickness correlation width global Bruch's membrane opening-minimum rim width (BMO-MRW).|imaging approximately 10 minutes|All usable images of one eye of each participant|||correlation coefficient|||Number
2594151|NCT02235311|Secondary|Community-Acquired Pneumonia|As defined by clinical suspicion and/or positive sputum culture requiring antibiotic treatment|8 weeks||||Participants|||Count of Participants
2594152|NCT02235311|Secondary|Clostridium Difficile Diarrhea|Clostridium difficile confirmed by polymerase chain reaction (PCR)|8 weeks||||Participants|||Count of Participants
2594153|NCT02235311|Secondary|Rate of Rebleed|"Per patient report or as defined by follow-up endoscopy per gastroenterology service, 8 weeks after UGIB acute management~High clinical suspicion of rebleed includes melena, hematochezia, confirmed by repeat endoscopy, requiring additional management"|8 weeks||||Participants|||Count of Participants
2594154|NCT02235311|Primary|Ulcer Healing|as defined by follow-up endoscopy per gastroenterology service, 8 weeks after UGIB acute management|8 weeks|1 ulcer located in duodenum, clean-base; randomized single-blinded to proton pump inhibitor (PPI) twice daily|||Participants|||Count of Participants
2594155|NCT02235285|Primary|Post Surgical Complications and Reoperation Rate During Breast Augmentation|The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.|5 years||||percentage of participants||Standard Deviation|Mean
2594156|NCT02235077|Other Pre-specified|Day 60 Mortality|All participants will be contacted by telephone at 60 days, +/- 3 days post randomization to assess vital status (death).|60 days post randomization||||Participants|||Count of Participants
2594157|NCT02235077|Secondary|96 Hour Change in Dyspnea Visual Analog Scale|Dyspnea visual analog scale change from randomization to 96 hours. Scale range 0-100 with 100 being the best possible score.|Randomization to 96 hours||||units on a scale||Standard Deviation|Mean
2594158|NCT02235077|Secondary|Presence of Outpatient Worsening Heart Failure Symptoms Through Day 30|Outpatient worsening heart failure symptoms will be assessed from discharge through Day 30|Hospital discharge through Day 30|All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.|||Participants|||Count of Participants
2594159|NCT02235077|Secondary|Change in Loop Diuretics Requirements From Baseline to 30 Days|Medications will be reviewed to assess loop diuretic dose requirements through Day 30 following randomization|Randomization through Day 30|All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.|||mg||Standard Deviation|Mean
2594160|NCT02235077|Secondary|96 Hour Change in Serum Potassium Levels|Change in serum potassium levels at 96 hours as compared to baseline.|Baseline, 96 hours|All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.|||mEq/L||Standard Deviation|Mean
2594161|NCT02235077|Secondary|96 Hour Change in Body Weight|Baseline body weight assessment will be completed, and changes in weight documented daily through 96 hours or earlier discharge|Randomization through 96 hours or earlier discharge||||pounds||Standard Deviation|Mean
2594162|NCT02235077|Secondary|96 Hour Net Fluid Output|Fluid intake and urine output will be assessed daily while in hospital through 96 hours. Net fluid output (output minus input) through 96 hours is reported.|Randomization through 96 hours|All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.|||ml||Standard Deviation|Mean
2594163|NCT02235077|Secondary|96 Hour Change in Serum Creatinine|Renal function via serum creatinine, will be assessed at randomization and daily through 96 hours|Randomization through 96 hours|All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.|||mg/dl||Standard Deviation|Mean
2594164|NCT02235077|Secondary|96 Hour Change in Dyspnea Likert Score|Dyspnea relief via 7-point Likert scale will be assessed at randomization, 96 hours, and at discharge. The Likert score was defined as 1=markedly improved, 2=moderately improved, 3=minimally improved; 4=no change, 5=minimally worse, 6=moderately worse, and 7=markedly worse as compared with the degree of dyspnea present at randomization.|Randomization through 96 hours|All data for completed assessments was analyzed. For outcomes where the number of participants analyzed is less than 182 spironolactone / 178 placebo, the number of subjects analyzed represents the number of subjects for whom the data was collected.|||Participants|||Count of Participants
2594165|NCT02235077|Secondary|96 Hour Change in Clinical Congestion Score|Clinical congestion score will be assessed at randomization, 96 hours, and at discharge. Scale consisted of sum of six signs and symptoms of congestion, each scored 0-3. Zero indicates no sign/symptom and 3 indicates worst case of sign/symptom. Score range 0-18 with 18 being worst score.|Randomization through 96 hours||||units on a scale||Standard Deviation|Mean
2594166|NCT02235077|Primary|96 Hour Change in NT-proBNP|The Core Laboratory at Vermont will determine NT-proBNP levels for calculation of the endpoint from samples obtained at randomization and 96 hours respectively. NT-proBNP was converted to log scale.|Randomization to 96 hours||||log pg/ml||Standard Deviation|Mean
2594167|NCT02235064|Secondary|Number of Participants With Perceived Infant Feeding Difficulties 12 Weeks Postpartum||12 weeks postpartum||||Participants|||Count of Participants
2594168|NCT02235064|Secondary|Number of Participants With Perceived Infant Feeding Difficulties 8 Weeks Postpartum||8 weeks postpartum||||Participants|||Count of Participants
2594169|NCT02235064|Secondary|Number of Participants With Perceived Infant Sleeping Difficulty at 12 Weeks Postpartum||12 weeks postpartum||||Participants|||Count of Participants
2594170|NCT02235064|Secondary|Number of Participants With Perceived Infant Sleeping Difficulty at 8 Weeks Postpartum||8 weeks postpartum||||Participants|||Count of Participants
2594171|NCT02235064|Secondary|Reported Infant Weight at 12 Weeks Following Delivery||12 weeks postpartum||||Grams||Full Range|Mean
2594172|NCT02235064|Secondary|Reported Infant Weight at 8 Weeks Following Delivery||8 weeks postpartum||||Grams||Full Range|Mean
2594173|NCT02235064|Secondary|Number of Participants With Perceived Infant Feeding Difficulties 4 Weeks Postpartum||4 weeks postpartum||||Participants|||Count of Participants
2594174|NCT02235064|Secondary|Number of Participants With Perceived Infant Sleeping Difficulty at 4 Weeks Postpartum||4 weeks postpartum||||Participants|||Count of Participants
2594175|NCT02235064|Secondary|Reported Infant Weight at 4 Weeks Following Delivery||4 weeks postpartum||||Grams||Full Range|Mean
2594176|NCT02235064|Secondary|Number of Participants With Adverse Reaction to Treatment Agent up to 12 Weeks Following Discharge From Hospital|The Antidepressant Side-Effect Checklist (ASEC) was employed to detect any adverse reaction to treatment regimens|Discharge from hospital to 12 weeks postpartum||||Participants|||Count of Participants
2594177|NCT02235064|Primary|Number of Participants With Development of Postpartum Depression up to 12 Weeks Following Discharge From Hospital|"Patients met with single psychiatrist (co-investigator), blinded to group assignment, who evaluated the patient using Edinburgh Postpartum Depression Screen, Hamilton Depression Rating Scale, Global Assessment of Functioning Scale, and clinical assessment~0 = No postpartum depression up to 12 weeks following discharge from hospital~1 = Postpartum depression up to 12 weeks following discharge from hospital"|Discharge from hospital to 12 weeks postpartum||||Participants|||Count of Participants
2594178|NCT02234843|Secondary|Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-<0.5 Years|This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.|Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||microgram per liter (mcg/L)||Standard Deviation|Mean
2594179|NCT02234843|Secondary|Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-<2 Years|This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.|Up to 3 hours post dose on Day 30, up to 6 hours post dose on Day 60, up to 16 hours on Day 90 and follow-up up to 30 days|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||microgram per liter (mcg/L)||Standard Deviation|Mean
2594180|NCT02234843|Secondary|Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-<6 Years|This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.|Up to 3 hours post dose on Day 30, up to 6 hours post dose on Day 60, and up to 16 hours on Day 90|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||microgram per liter (mcg/L)||Standard Deviation|Mean
2594181|NCT02234843|Secondary|Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-<2 Years|This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.|Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||microgram per liter (mcg/L)||Standard Deviation|Mean
2594182|NCT02234843|Secondary|Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-<6 Years|This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.|Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 16 hours on Day 90|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||microgram per liter (mcg/L)||Standard Deviation|Mean
2594183|NCT02234843|Secondary|Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-<12 Years|This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.|Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 16 hours on Day 90|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||microgram per liter (mcg/L)||Standard Deviation|Mean
2594184|NCT02234843|Secondary|Anti-Xa Values: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-<12 Years|This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.|Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 24 hours on Day 90|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||microgram per liter (mcg/L)||Standard Deviation|Mean
2594185|NCT02234843|Secondary|Anti-Xa Values: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-<18 Years|This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.|Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 24 hours on Day 90|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||microgram per liter (mcg/L)||Standard Deviation|Mean
2594186|NCT02234843|Secondary|Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-<0.5 Years|The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.|Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||ratio||Standard Deviation|Mean
2594187|NCT02234843|Secondary|Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-<2 Years|The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.|Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||ratio||Standard Deviation|Mean
2594188|NCT02234843|Secondary|Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-<6 Years|The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.|Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||ratio||Standard Deviation|Mean
2594189|NCT02234843|Secondary|Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-<2 Years|The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.|Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||ratio||Standard Deviation|Mean
2594190|NCT02234843|Secondary|Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-<6 Years|The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.|Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||ratio||Standard Deviation|Mean
2594191|NCT02234843|Secondary|Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-<12 Years|The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.|Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||ratio||Standard Deviation|Mean
2594192|NCT02234843|Secondary|Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-<12 Years|The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.|Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||ratio||Standard Deviation|Mean
2594193|NCT02234843|Secondary|Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-<18 Years|The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.|Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||ratio||Standard Deviation|Mean
2594194|NCT02234843|Secondary|Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-<0.5 Years|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.|Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||ratio||Standard Deviation|Mean
2594195|NCT02234843|Secondary|Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-<2 Years|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.|Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||ratios||Standard Deviation|Mean
2594196|NCT02234843|Secondary|Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-<6 Years|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.|Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||ratio||Standard Deviation|Mean
2594197|NCT02234843|Secondary|Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-<2 Years|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.|Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||ratio||Standard Deviation|Mean
2594198|NCT02234843|Secondary|Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-<6 Years|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.|Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||ratio||Standard Deviation|Mean
2594199|NCT02234843|Secondary|Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-<12 Years|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.|Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||ratio||Standard Deviation|Mean
2594200|NCT02234843|Secondary|Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-<12 Years|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.|Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||ratio||Standard Deviation|Mean
2594201|NCT02234843|Secondary|Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-<18 Years|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.|Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60|Participants in pharmacodynamics set (PDS) were analyzed for this endpoint.|||ratio||Standard Deviation|Mean
2594202|NCT02234843|Secondary|Ctrough,ss in Plasma|Ctrough,ss refers to the drug concentration at the end of the dosage interval at steady state|0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours(one sampling interval in steady state)|Pharmacokinetics analysis set (PKS)|||microgram per liter||Geometric Coefficient of Variation|Geometric Mean
2594203|NCT02234843|Secondary|Cmax,ss in Plasma|Maximum drug concentration in measured matrix at steady state during a dosage interval|0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours (one dosing interval in steady state)|Pharmacokinetics analysis set (PKS)|||microgram per liter||Geometric Coefficient of Variation|Geometric Mean
2594204|NCT02234843|Secondary|AUC(0-24)ss in Plasma|AUC(0-24)ss: Area under the concentration vs. time curve from time 0 to 24 hours at steady state.|over 24 hours|Pharmacokinetics analysis set (PKS)|||microgram*hour per liter||Geometric Coefficient of Variation|Geometric Mean
2594205|NCT02234843|Secondary|Incidence Rates of the Composite of All Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging During the Main Treatment Period|The secondary efficacy outcome defined as the composite of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging as assessed by central independent adjudication committee. (CIAC) Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population|During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)|Full analysis set (FAS)|||Percentage of participants||95% Confidence Interval|Number
2594218|NCT02234752|Secondary|Kynurenic Acid (KYNA)|The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. MS* AUC is mass spectrometry times area under the curve.|Baseline and 6-Weeks|Participant 3 only provided baseline data|||MS* AUC||Standard Deviation|Mean
2594219|NCT02234752|Secondary|Free Tryptophan (TRP)|The secondary outcome measure will be change in metabolite values. Values were collected in triplicate.|Baseline and 6-Weeks|Participant 3 only provided baseline data|||µM||Standard Deviation|Mean
2594231|NCT02234622|Secondary|Beck Depression Inventory-II|Depression will be measured by the Beck Depression Inventory (BDI), a 21-item self-report measure, the total score of which ranges 0-63 with higher scores indicating a poorer outcome.|Change from baseline to 16 weeks (end of treatment)|three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria|||score on a scale||Standard Deviation|Mean
2594206|NCT02234843|Primary|Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Extended Treatment Period|Incidence rates for all children except those aged < 2 years with catheter-related thrombosis. If no participant entered in the specific optional extension period, no analysis of an outcome was possible. The CIAC classified bleeding as: Major bleeding defined as overt bleeding and: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteria for major bleeding, but associated with: medical intervention, or unscheduled contact with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life.|During extended treatment period: up to month 12.|Safety analysis set (SAF)|||Percentage of participants||95% Confidence Interval|Number
2594207|NCT02234843|Primary|Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period|The Central independent adjudication committee (CIAC) classified bleeding as: Major bleeding defined as overt bleeding and: · associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteria for major bleeding, but associated with: medical intervention, or unscheduled contact (visit or telephone call) with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life (such as loss of school days or hospitalization).|During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)|Safety analysis set (SAF)|||Percentage of participants||95% Confidence Interval|Number
2594208|NCT02234843|Primary|Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period|The Central independent adjudication committee (CIAC) classified bleeding as: Major bleeding defined as overt bleeding and: · associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteria for major bleeding, but associated with: medical intervention, or unscheduled contact (visit or telephone call) with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life (such as loss of school days or hospitalization).|During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)|Safety analysis set (SAF)|||Percentage of participants||95% Confidence Interval|Number
2594209|NCT02234843|Primary|Number of Subjects With the Composite of All Symptomatic Recurrent Venous Thromboembolism During the 30 Days Post-study Treatment Period (i.e. >2 and ≤ 30 Days After Stop of Study Medication)|The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Age group with primary efficacy outcome was reported.|More than 2 and up to 30 days after stop of study medication|Full analysis set (FAS)|||Participants|||Count of Participants
2594210|NCT02234843|Primary|Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period|Incidence rates for all children except those aged < 2 years with catheter-related thrombosis. If no participant in the specific subgroup entered in the specific optional extension period, no analysis of an outcome was possible., The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference Population.|During extended treatment period: up to month 12.|Full analysis set (FAS)|||Percentage of participants||95% Confidence Interval|Number
2594211|NCT02234843|Primary|Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period|The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population|During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)|Full analysis set (FAS)|||Percentage of participants||95% Confidence Interval|Number
2594212|NCT02234843|Primary|Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period|The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population|During the main study treatment period (i.e., 3 months, except for children with central venous catheter venous thromboembolism (CVC-VTE) aged <2 years for whom it was 1 month)|Full analysis set (FAS)|||Percentage of participants||95% Confidence Interval|Number
2594213|NCT02234752|Secondary|PIC/KYN|The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. AUC ratio reported.|Baseline and 6-Weeks|Participant 3 only provided baseline data|||AUC Ratio|||Number
2594214|NCT02234752|Secondary|KYNA/KYN|The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. AUC ratio reported.|Baseline and 6-Weeks|Participant 3 only provided baseline data|||AUC Ratio|||Number
2594215|NCT02234752|Secondary|KYN/TRP|The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. AUC ratio reported.|Baseline and 6-Weeks|Participant 3 only provided baseline data|||AUC Ratio|||Number
2594216|NCT02234752|Secondary|Picolinic Acid (PIC)|The secondary outcome measure will be change in metabolite values. Values were collected in triplicate. MS* AUC is mass spectrometry times area under the curve.|Baseline and 6-Weeks|Participant 3 only provided baseline data|||MS* AUC||Standard Deviation|Mean
2594220|NCT02234752|Primary|Change in Level of Cognition|The primary outcome measure will be the change in level of cognition as measured by the MATRICS Consensus Cognitive Battery (MCCB). In schizophrenia, usual composite scores are 20-39. In healthy controls, usual composite scores are normalized to 40-60. Higher values of composite scores mean better cognition. Test scores are normalized to healthy controls, therefore no min-max range is available. Final scores calculated by MATRICS Consensus Cognitive Battery software. Exact minimum/maximum are not known to provider. Overall composite scores are reported.|Baseline and 6-Weeks|Participant 3 only provided baseline data|||units on a scale|||Number
2594221|NCT02234713|Secondary|Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): MSNQ|Multiple Sclerosis Neuropsychological Screening Assessment Questionnaire (MSNQ): Neurocognitive Functioning will be assessed using the informant-report version of the Multiple Sclerosis Neuropsychological Screening Assessment Questionnaire (MSNQ). This 15-item tool has documented high test-retest stability, predictive validity, and construct validity. Informant reports are documented to be reliably correlated with cognitive dysfunction and be less biased by patient depression. Total scores range from 0 to 60 with a higher score indicating worse cognitive functioning.|Baseline, 3 months, 6 months|The number analyzed may differ from the overall number analyzed when not all participants completed each measure.|||Score on a scale||Standard Deviation|Mean
2594222|NCT02234713|Primary|Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement|Parental involvement in DMT administration (Parental Involvement): Percentage of time the parent reported (1) reminding the child to take her/his DMT; (2) being present when the child took her/his DMT; and (3) administering the child's DMT.|Baseline, 3 months, 6 months|Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)|||Percentage of time||Standard Deviation|Mean
2594223|NCT02234713|Primary|Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky|Morisky Adherence Scale (Morisky): A widely used 8-item patient-/parent-reported measure with documented reliability and validity. Total scores range from 0 to 8.The following scoring algorithm was used: 8 = high adherence, 6-7 = medium adherence, and <6=low adherence.|Baseline, 3 months, 6 months|Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)|||Score on a scale||Standard Deviation|Mean
2594224|NCT02234713|Other Pre-specified|Well-Being|Autonomy and Environmental Mastery subscale scores (Ryff Scales of Psychological Well-Being) will be compared at baseline, three months, and six months between the two study arms.|baseline, three months, and six months|||||||
2594225|NCT02234713|Secondary|Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL|Pediatric Quality of Life Inventory (PedsQL): A 23-item tool with subscales for physical, social, emotional, and school functioning. The PedsQL has documented reliability and validity, and has been used in a large number of pediatric quality-of-life studies. Subscale scores range from 0 to 100 with higher scores representing better functioning.|Baseline, 3 months, 6 months|The number analyzed may differ from the overall number analyzed when not all participants completed each measure.|||Score on a scale||Standard Deviation|Mean
2594226|NCT02234713|Primary|Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ|Multiple Sclerosis Treatment Adherence Questionnaire (MSTAQ): Assesses missed doses, side effects and barriers of taking DMTs, and behavioral coping strategies used (e.g., icing the injection site, taking pain medication) over the past four weeks. We adapted the MSTAQ to include both oral and injectable medications. We used a standardized scoring algorithm (0-100), where higher scores reflected higher numbers of missed doses, side effects, barriers, or behavioral coping strategies. Subjects completed only the barriers items, and the parent completed all items.|Baseline, 3 months, 6 months|Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)|||Score on a scale||Standard Deviation|Mean
2594227|NCT02234713|Primary|Change in Level of Adherence in Subjects (Objective Measure)|Objective measures included: (A) pharmacy refill data provided by site coordinators for 12 months prior to study entry and for 6 months post-study entry and (B) the MEMS cap, an EM device (MEMS, AARDEX) that captures each time the patient discards a needle from their injection or opens their pill bottle. Adherence information from MEMS caps is downloaded and stored on a secured web-platform (medAmigo™). These data were used to compile drug-dosing history data and to calculate medication adherence during the course of the study.|Baseline, 3 months, 6 months|Behavioural Intervention /Feedback and Video Attention Control Arms were combined to look at changes in adherence over time (baseline, 3-months and 6-months)|||Proportion of doses (actual vs expected)||Standard Deviation|Mean
2594228|NCT02234687|Primary|To Evaluate the Effect of 160mg and 40mg of Pomaglumetad Methionil|To evaluate the effect of 160mg and 40mg challenge of the mGlu2/3 receptor agonist pomaglumetad methionil relative to placebo in mitigating fear-potentiated startle using the neutral-predictable-unpredictable fear-potentiated startle paradigm in adults with post-traumatic stress disorder (PTSD). The primary index of unpredictable fear will be the difference score between startle magnitude in safe and unpredictable conditions in the absence of the cue.|6 months|10 patients were enrolled and data for these 10 patients was not analyzed. Assuming a 2-tailed test,power=0.80, alpha=0.05, a total sample size of 30 (10 per group) is required to detect a moderate differential effect size change of a 160mg or 40 mg dose of pomaglumated methionil relative to placebo.||||||
2594229|NCT02234622|Secondary|Brief Pain Inventory (BPI) Item #3|Pain will be assessed using the Brief Pain Inventory (BPI), item #3 which is an indicator of average pain severity in the past week. Scores range from 0-10 with higher scores indicating poorer outcome.|Change from baseline to 16 weeks (end of treatment)|three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria|||score on a scale||Standard Deviation|Mean
2594230|NCT02234622|Secondary|Spielberger State-Trait Anxiety (STAI) - State Subscale|Anxiety will be measured by the Spielberger State-Trait Anxiety Inventory (STAI), State Anxiety subscale, a self-report instrument consisting of 20-items rated on a 4-point scale (1-4), with a possible range of 20-80. Higher scores indicate worse outcome.|Change from baseline to 16 weeks (end of treatment)|three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria|||score on a scale||Standard Deviation|Mean
2594232|NCT02234622|Secondary|Patient Reported Outcome Measure Information System (PROMIS) - Short Form 5a|PROMIS - short form 5a is a 5-item self-report measure to assess feelings of anger over the past 7 days. Total scores, ranging 5-25 are converted to T-scores with higher scores indicating poorer outcome. A score of 50 represents the mean. A difference of 10 from the mean indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean. T-scores range from 0-100|Change from baseline to 16 weeks (end of treatment)|three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria|||score on a scale||Standard Deviation|Mean
2594233|NCT02234622|Secondary|Medical Outcomes Study 12-item Sleep Scale (MOS) Problem Index II|Medical Outcomes Study Sleep Scale (MOS) Problem Index II is a 9-item sub-scale of the 12-item MOS self-report measure that assesses sleep quality (sleep disturbance, adequacy of sleep, and sleep quantity). The item scores of the 9-item sub-scale range from 1-6 and the sub-scale totals are converted to scores ranging 0-100, with higher scores indicating a worse outcome.|Change from baseline to 16 weeks (end of treatment)|three participants were removed from the analysis when a retrospective audit of the Clinician Administered PTSD Scale revealed they did not meet diagnostic criteria for PTSD|||score on a scale||Standard Deviation|Mean
2594234|NCT02234622|Primary|PTSD Checklist|PTSD self-reported symptom severity will be assessed with the PTSD Checklist-5 (PCL-5), a 20-item self-report measure of the 5th version of the Diagnostic and Statistics Manual (DSM-5) symptoms of PTSD used as a measure of change in PTSD symptoms as a function of treatment. Scores range 0-80 with higher scores indicating worse outcome.|Change from baseline to 16 weeks (end of treatment)|three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria|||score on a scale||Standard Deviation|Mean
2594235|NCT02234622|Primary|Clinician Administered PTSD Scale (CAPS-5)|The CAPS is a semi-structured clinician administered interview that measures PTSD diagnostic status and symptom severity consistent with the Diagnostic and Statistical Manual-Fifth Edition. Scores range 0-80 with higher scores meaning a worse outcome.|Change from baseline to 16 weeks (end of treatment)|three participants were removed from the analysis when results of a retrospective audit of baseline PTSD diagnosis indicated they did not meet diagnostic criteria|||score on a scale||Standard Deviation|Mean
2594236|NCT02234570|Secondary|Urine Concentrations of Oxfendazole Sulfone|Concentrations of oxfendazole sulfone in urine were measured using a validated HPLCMS/MS method. Concentrations <LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.|Day 1-Day 15|All participants receiving oxfendazole are included in the analysis population.|||ng/mL||Standard Deviation|Mean
2594237|NCT02234570|Secondary|Urine Concentrations of Oxfendazole Fenbendazole|Concentrations of oxfendazole fenbendazole in urine were measured using a validated HPLCMS/MS method. Concentrations <LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.|Day 1-Day 15|All participants receiving oxfendazole are included in the analysis population.|||ng/mL||Standard Deviation|Mean
2594238|NCT02234570|Secondary|Time of Maximum Observed Concentration (Tmax) of Oxfendazole|Tmax was defined as the time at which the maximum concentration (Cmax) occurs in plasma computed from concentrations that were measured using a validated HPLCMS/MS method.|0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose|All participants receiving oxfendazole are included in the analysis population.|||hours||Full Range|Median
2594239|NCT02234570|Secondary|Terminal Elimination Half-life (t1/2) of Oxfendazole|The apparent terminal elimination half-life (t1/2) was defined as the time required for the drug concentration to decrease by a factor of one-half in the terminal phase computed from concentrations that were measured using a validated HPLCMS/MS method.|0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose|All participants receiving oxfendazole are included in the analysis population.|||hours||Standard Deviation|Mean
2594240|NCT02234570|Secondary|Plasma Concentrations of Oxfendazole Sulfone|Concentrations of oxfendazole sulfone in plasma were measured using a validated HPLCMS/MS method. Concentrations <LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.|Day 1-Day15|All participants receiving oxfendazole are included in the analysis population|||ng/mL||Standard Deviation|Mean
2594241|NCT02234570|Secondary|Plasma Concentrations of Oxfendazole Fenbendazole|Concentrations of oxfendazole fenbendazole in plasma were measured using a validated HPLCMS/MS method. Concentrations <LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.|Day 1-Day15|All participants receiving oxfendazole are included in the analysis population|||ng/mL||Standard Deviation|Mean
2594242|NCT02234570|Secondary|Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma|Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations computed from concentrations that were measured using a validated HPLC-MS/MS method.|0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose|All participants receiving oxfendazole are included in the analysis population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2594243|NCT02234570|Secondary|Area Under the Concentration Time-curve From Time Zero to Infinity (AUC(0-infinity)) for Oxfendazole|AUC(0-infinity) was defined as the total area under the concentration-time curve from dosing (time 0) taken to the limit as the end time becomes arbitrarily large. AUC(0-infinity) and was calculated by adding AUC(0-last) to an extrapolated value equal to the last measured concentration greater than the lower limit of quantification of the bioanalytical assay divided by the terminal phase elimination rate constant (Ke) computed from concentrations that were measured using a validated HPLCMS/MS method|0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose|All participants receiving oxfendazole are included in the analysis population.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2594244|NCT02234570|Primary|Number of Subjects Reporting Adverse Events Related to Oxfendazole Within 14 Days of Receipt of a Single Oral Dose.|"All adverse events, defined as any untoward medical occurrence regardless of its causal relationship to the study treatment, were collected for 14 days after dosing. The PI then determined relatedness to the study drug. Related was defined as there is a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event."|Within 14 Days of first dose|All participants are included in the analysis population.|||Participants|||Count of Participants
2594245|NCT02234479|Primary|Number of Participants Whom Received Medihoney Treatment and Were Analyzed Weekly for Skin Changes While Undergoing Radiation Therapy|The aim of this study is to compare the effects of Medihoney and Hydrophor on radiation dermatitis reactions in a group of women undergoing radiation therapy for breast cancer. It is hoped that the outcome of this pilot study will provide evidence supporting the use of Medihoney in preventing and treating radiation dermatitis as well as sufficient preliminary data to expand this study to larger, federally funded research (R01) looking at the beneficial aspects of Medihoney across a spectrum of radiation dermatitis and mucositis in several disease settings.|12 months|Participants were analyzed for skin changes (during weekly visits with physician) during radiation treatment. Only 15 participants from each group completed the study, 1 subject from Group A and 3 subjects from Group B withdrew.|||participants|||Number
2594246|NCT02234427|Primary|Differential Gene Expression|Differences in platelet transcriptome before and after 2-week aspirin therapy The expression levels of genes before aspirin therapy was compared with the expression level of the genes after aspirin therapy. The expression levels were measured using the FPKM unit (Fragments Per Kilobase of transcript per Million mapped reads). The gene with the highest difference (pre vs. post) in FPKM is being reported with name in the units area and the actual difference in the number area|2-weeks|The data were analyzed combining results from two studies (24 from this study and additional 33 individuals from study NCT01894555; total population size = 57) to improve the power to detect a difference. Same results are reported for the two studies. Note that the top most gene (HBG1) with the lowest p-value is being reported.|||FPKM for HBG1 Gene||Standard Error|Mean
2594247|NCT02234362|Secondary|Change From Baseline in Digit Symbol Substitution Test (DSST) Score at Week 8 (Visit 5)|"Processing speed, working memory, visuospatial processing and attention was assessed by the Digit Symbol Substitution Test (DSST).~The DSST test requires the examinee to transcribe a unique geometric symbol with its corresponding Arabic number. The examinee is initially shown a key containing the numbers from 1 to 9. Under each number there is a corresponding geometric symbol. The examinee is then shown a series of boxes containing numbers in the top boxes, and blank boxes below them. After a short practice trial, they are then asked to copy the corresponding geometric symbol under each number. The raw score is the number of correct items completed within the prescribed time limit. Higher scores indicate faster processing speed, working memory, and visuospatial processing and attention. The range of scores is 0-63."|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.|||units on a scale||Inter-Quartile Range|Median
2594248|NCT02234362|Secondary|Change From Baseline in Greene Climacteric Scale (GCS) Score at Week 8 (Visit 5)|"Menopause related symptoms were assessed using the Greene Climacteric Scale (GCS). The Greene Scale provides a brief measure of menopause symptoms. It can be used to assess changes in different symptoms, before and after menopause treatment. Three main areas are measured:~1. Psychological (items 1-11). 2. Physical (items 12-18). 3. Vasomotor (items 19, 20).~A higher score indicates that menopause symptoms are more bothersome. The range of scores is from 0 to 63."|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.|||units on a scale||Inter-Quartile Range|Median
2594249|NCT02234362|Secondary|Change From Baseline in Pain Assessment (PEG) Score at Week 8 (Visit 5)|Pain symptoms were assessed by the Pain Assessment (PEG). The PEG is a three-item scale assessing pain intensity and interference. A higher score indicates more pain symptoms. The range of scores is from 0 to 30.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.|||units on a scale||Inter-Quartile Range|Median
2594250|NCT02234362|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Score at Week 8 (Visit 5)|Severity of illness was assessed by the Clinical Global Impression-Severity (CGI-S) Scale. The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. The range of scores is 0-7. Higher scores indicate greater severity of illness.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.|||units on a scale||Inter-Quartile Range|Median
2594251|NCT02234362|Secondary|Change From Baseline in Clinical Global Impression-Fatigue (CGI-F) Scale Score at Week 8 (Visit 5)|Fatigue symptoms were assessed by the Clinical Global Impression-Fatigue (CGI-F) scale.The CGI-F is a single item global assessment scales to specifically evaluate symptoms of fatigue. Higher scores indicate more fatigue symptoms. The range of scores is from 0-7.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.|||units on a scale||Inter-Quartile Range|Median
2594252|NCT02234362|Secondary|Change From Baseline in Menopause Specific Quality of Life (MENQOL) Score at Week 8 (Visit 5)|"Quality of life, menopause-specific, is assessed by the Menopause Specific Quality of Life (MENQOL).~The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to six (extremely bothersome) scale. Means are computed for each subscale by dividing the sum of the domain's items by the number of items within that domain. Non-endorsement of an item is scored a 1 and endorsement a 2, plus the number of the particular rating, so that the possible score on any item ranges from 1-8. Total score also ranges from 1-8. Higher scores indicate that menopause symptoms are more bothersome."|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.|||units on a scale||Inter-Quartile Range|Median
2594305|NCT02234115|Secondary|Number of Participants With Adverse Events (AEs)|Safety analysis was based on the safety information from the laboratory evaluations, AEs, and SAEs.|336 days|Safety population|||Participants|||Count of Participants
2594253|NCT02234362|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 8 (Visit 5)|Sleep quality and disturbances during the past month were assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI also incorporates daytime functioning into the total score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. The range of scores is 0-21.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.|||units on a scale||Inter-Quartile Range|Median
2594254|NCT02234362|Secondary|Change From Baseline in Beck Anxiety Inventory (BAI) Score at Week 8 (Visit 5)|Anxiety was measured by self-report responses to Beck Anxiety Inventory (BAI). It is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in children and adults. Several studies have found the Beck Anxiety Inventory to be an accurate measure of anxiety symptoms in children and adults. Higher scores on the BAI indicate more anxiety symptoms. The range of BAI scores is from 0 to 63, with 0-9=Minimal anxiety, 10-16=Mild anxiety, 17-29=Moderate anxiety, and 30-63=Severe anxiety.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.|||units on a scale||Inter-Quartile Range|Median
2594255|NCT02234362|Secondary|Change From Baseline in Cognitive and Physical Functioning Questionnaire (CPFQ) Score at Week 8 (Visit 5)|Cognition and physical functioning was measured by self-report responses to Cognitive and Physical Functioning Questionnaire (CPFQ).The range of scores is from 7-42. Higher scores indicate lower cognitive and executive functioning.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation.|||units on a scale||Inter-Quartile Range|Median
2594256|NCT02234362|Secondary|Change From Baseline in Vasomotor Symptoms (VMS) Severity During Nighttime at Week 8 (Visit 5)|"Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night.~Severity of VMS:~The range of scores for severity of VMS is 0-2, with higher scores indicating greater severity. 0=mild, 1=moderate, 2=severe"|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation who also reported having hot flashes at baseline.|||units on a scale||Standard Deviation|Mean
2594257|NCT02234362|Secondary|Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Nighttime at Week 8 (Visit 5)|Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation who also reported having hot flashes at baseline.|||hot flashes per night||Standard Deviation|Mean
2594258|NCT02234362|Secondary|Change From Baseline in Vasomotor Symptoms (VMS) Severity During Daytime at Week 8 (Visit 5)|"Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night.~Severity of VMS:~The range of scores for severity of VMS is 0-2, with higher scores indicating greater severity. 0=mild, 1=moderate, 2=severe"|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation who also reported having hot flashes at baseline.|||units on a scale||Standard Deviation|Mean
2594259|NCT02234362|Secondary|Change From Baseline in Vasomotor Symptoms (VMS) Frequency During Daytime at Week 8 (Visit 5)|Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night.|Baseline and Week 8 (Visit 5)|The analyzable population includes all participants who initiated treatment with vortioxetine and returned for at least one assessment after study medication initiation who also reported having hot flashes at baseline.|||hot flashes per day||Standard Deviation|Mean
2594260|NCT02234362|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale Score (MADRS) at Week 8 (Visit 5)|The efficacy of vortioxetine for trea-ting depressive symptoms was measured by mean change in Montgomery-Asberg Depression Rating Scale (MADRS) depression score from Baseline (Visit 1) to Week 8 (Visit 5). The MADRS score was assessed at every study visit (Visits 1-5). Participants were considered to have responded to vortioxetine if their MADRS score was reduced by 50% or more from baseline to the end of treatment, and to be in remission if their final MADRS score was less than 10. Higher MADRS score indicates more severe depression. The overall MADRS score ranges from 0 to 60.|Baseline and Week 8 (Visit 5)|The analyzable population includes all 24 participants who initiated medication treatment and returned for at least one assessment after starting vortioxetine. A last observation carried forward (LOCF) analysis was used.|||units on a scale||Standard Deviation|Mean
2594261|NCT02234284|Post-Hoc|Proportion (%) of Participants Receiving Guideline-concordant Medications for COPD.|Prescription of medications for COPD in concordance with the recommendations from the Global Initiative for Obstructive Lung Disease (GOLD) Guideline, based on classification categories of A, B C or D.|9 month study period||||Participants|||Count of Participants
2594323|NCT02233842|Primary|Number of Smokers at the Time of the Interview|Current, former, and cigar smokers at the time the interview (e.g. Cancer Patient Tobacco Use Questionnaire (C-TUQ)) was initiated.|Day 1 of interview||||participants|||Number
2594262|NCT02234284|Post-Hoc|Proportion (%) of Patients With a Score of >/= 15 on the Patient Health Questionnaire 8 Item Version|Patient Health Questionnaire (PHQ) 8 item version (without suicidality item) of the PHQ-9. The 8 items, which ask about the frequency of symptoms of depression, are answered on a likert-type scale from 0 to 3, with 0= 'not at all' and 3='nearly every day'. The total score ranges from 0 to 24, with a higher score indication more more severe depression symptoms. A score of >/= 15 indicates symptoms of at least moderate depression.|9 month study period||||Participants|||Count of Participants
2594263|NCT02234284|Other Pre-specified|Rate of Hospitalizations Not for COPD|Number of hospitalizations other than for COPD per patient per year during 9 month study period|Over 9 month study period||||Hospitalizations per patient per year||Standard Deviation|Mean
2594264|NCT02234284|Other Pre-specified|Rate of Hospitalization for COPD|Number of hospitalizations for COPD per patient per year over 9 month study period|Over 9 month study period||||Hospitalizations per patient per year||Standard Deviation|Mean
2594265|NCT02234284|Other Pre-specified|Rate of ED Visits Not for COPD|Number of visits to emergency department other than for COPD related reason per patient per year during 9 month study period|Over 9 month study period||||Visits per patient per year||Standard Deviation|Mean
2594266|NCT02234284|Other Pre-specified|Rate of ED Visits for COPD|Number of ED visits for COPD per patient per year over 9 month study period|Over 9 month study period||||Visits per patient per year||Standard Deviation|Mean
2594267|NCT02234284|Other Pre-specified|Rate of Outpatient Visits|Number of outpatient visits per patient per year|Over 9 month study period||||visits per patient per year||Standard Deviation|Mean
2594268|NCT02234284|Other Pre-specified|Proportion (%) of Participants With Correct Answer to Knowledge Question 4|Smoking does not help breathing|9 months||||Participants|||Count of Participants
2594269|NCT02234284|Other Pre-specified|Proportion (%) of Participants With Correct Answer to Knowledge Question 3|Okay to be on oxygen for long period|9 months||||Participants|||Count of Participants
2594270|NCT02234284|Other Pre-specified|Proportion (%) of Participants With Correct Answer to Knowledge Question 2|beneficial to stop smoking|9 months||||Participants|||Count of Participants
2594271|NCT02234284|Other Pre-specified|Proportion (%) of Participants With Correct Answer to Knowledge Question 1|Okay to get short of breath while exercising|9 months||||Participants|||Count of Participants
2594272|NCT02234284|Other Pre-specified|Proportion (%) of Participants Demonstrating Adequate Inhaler Use|Observational measure using a check list to document mistakes in using inhalers. Adequate use defined as correctly performing all necessary steps for every inhaler used. Definition of necessary steps varies by type of inhaler.|9 months||||Participants|||Count of Participants
2594273|NCT02234284|Other Pre-specified|COPD-related Function (Bed Days Due to Respiratory Problems)|Number of days in past 4 weeks where COPD keep participant in bed all or most of the day.|9 months|Participants reporting bed days at 9 monhts|||Days||Standard Deviation|Mean
2594274|NCT02234284|Other Pre-specified|Proportion (%) of Participants Reporting Current Cigarette Use|Current cigarette use is defined as any use in the past 30 days.|9 months|Participants reporting smoking status at 9 months|||Participants|||Count of Participants
2594275|NCT02234284|Other Pre-specified|Percent of Predicted Force Expiratory Volume at 1 Second (FEV1)|Volume of air exhaled, using maximal force, over 1 second, divided by the volume expected for health person of same age and gender. Larger volume indicates better lung function.|9 months|Participants completing measurement of FEV1 % Predicted at 9 months|||Percent of predicted value||Standard Error|Mean
2594276|NCT02234284|Other Pre-specified|COPD Assessment Test|The COPD Assessment Test (CAT) is an 8-item measure of severity of COPD symptoms, with responses from 1 to 5 . It is scored as the sum of item scores, with a range from 8 to 40, with a higher score indicating greater level of symptoms.|9 months||||units on a scale||Standard Deviation|Mean
2594277|NCT02234284|Other Pre-specified|Short Version of the Patient Assessment of Quality of Care (PACIC)|Patient Assessment of Chronic Illness Care (PACIC) is a patient reported measure of having received services recommended by Chronic Care Model. The short version of the PACIC has 11 items asking the patient the proportion of time he or she received a specific service. Each item is answered on a 5-point Likert-type scale with 1=None of the time and 5=Always. The total score is the mean of all 11-items. Mean scores range for 1 to 5, with a higher score indicating higher quality of care.|9 months||||units on a scale||Standard Deviation|Mean
2594278|NCT02234284|Secondary|Self-efficacy to Manage Chronic Disease Scale|"The Self-efficacy to Manage Chronic Disease Scale is a validated measure of of patient self-efficacy for managing a specific chronic disease (in this case, COPD). The Self-efficacy to Manage Chronic Disease Scale has 6 items asking about patients' self-confidence dealing with 6 aspects off self-management. Each item is answered on a scale of 1 to 10 with 1=not at all confident and 10='totally confident. The score is the mean of all 10-items. Mean scores range for 1 to 10, with a higher score indicating greater self-efficacy for managing COPD."|9 months||||units on a scale||Standard Deviation|Mean
2594279|NCT02234284|Secondary|Exercise Capacity (6-minute Walk Test)|Distance walked, in meters, over 6 minutes. Higher number indicates greater exercise capacity.|9 months||||Meters||Standard Deviation|Mean
2594280|NCT02234284|Secondary|Rate of COPD Exacerbations Per Year|A COPD exacerbation was defined as a COPD-related emergency department visit or hospitalization, or the outpatient prescription of oral steroids and/or antibiotic for COPD-related diagnosis, as documented in the medical record over the 9 month trial period. The rate of COPD exacerbation was calculated as the mean number of exacerbations per participant per year.|Over 9 month study period||||events||Standard Deviation|Mean
2594281|NCT02234284|Primary|Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF)|The CRQ-SF is the short-form version of the original Chronic Respiratory Disease Questionnaire. The CRQ-SF has a total of 8 items asking about the frequency of COPD-related symptoms in 4 domains (2 questions per domain): Dyspnea, Fatigue, Emotional Function and Mastery. Each item is answered on a 7-point Likert-type scale with 1=none of the time and 7=all of the time. The dyspnea score is reported as the mean of the two items asking about shortness of breath. Mean scores range for 1 to 7, with a higher score indicating a worse quality of life related to dyspnea.|9 months||||units on a scale||Standard Deviation|Mean
2594324|NCT02233842|Primary|Number of Participants to Achieve Saturation in an English-language Paper Questionnaire|Saturation is defined as satisfactory measurement of performance without need of further review.|Last subject interviewed, an average of 5 months||||participants|||Number
2594282|NCT02234284|Primary|Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score|The Chronic Respiratory Disease Questionnaire assesses disease-related quality of in 4 domains (dyspnea, fatigue, physical function and mastery). The 8-item Short Form version has been validated against the original full version. Each item is answered on a 7-point response scale where a higher score indicates a higher quality of life. The measure is scored as the mean response score (range 1 to 7) for each domain and for the total score, with the higher score indicating higher quality of life.|9 months|All participants who completed the CRQ-SF at 9 months|||units on a scale||Standard Deviation|Mean
2594283|NCT02234180|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from randomization to death due to any cause.|Time from randomization to death due to any cause, assessed up to 1 year and 10 months|Only 1 patient was registered to the placebo arm. Due to protected health information, listing only 1 patient's results is contraindicated. The data below is descriptive and shouldn't be trusted because of the small sample size.|||months||95% Confidence Interval|Median
2594284|NCT02234180|Secondary|Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)|"The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below."|Up to 1 year and 10 months|Only 1 patient was registered to the placebo arm. Due to protected health information, listing only 1 patient's results is contraindicated. The data below is descriptive and shouldn't be trusted because of the small sample size.|||percentage of grade 3+ AEs|||Number
2594285|NCT02234180|Primary|Disease Free Survival (DFS)|Disease free survival (DFS) is defined as the time from randomization to the first of either disease recurrence or death from any cause. The distribution of DFS will be estimated using the Kaplan Meier method.|Time from randomization to the first of either disease recurrence or death from any cause, assessed up to 1 year and 10 months|Only 1 patient was registered to the placebo arm. Due to protected health information, listing only 1 patient's results is contraindicated. The data below is descriptive and shouldn’t be trusted because of the small sample size.|||months||95% Confidence Interval|Median
2594286|NCT02234141|Secondary|Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Right Ventricular Fractional Area Change (RVFAC)|RVFAC is an echocardiographic assessment of right ventricular function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of RV area||Standard Error|Mean
2594287|NCT02234141|Secondary|Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Right Ventricular Tei Index (RVTI)|The Tei-index is defined as the sum of the isovolumic contraction and the isovolumic relaxation time divided by ejection time, and thus incorporates elements of both systolic and diastolic phases in the assessment of global ventricular function. An increased Tei-index results from ventricular dysfunction and provides prognostic information for a variety of myocardial conditions. The RVTI is a candidate to increase the non-invasive diagnosis of PAH because it reflects the right ventricular function, is easy to assess, and can be estimated in the same session as the echocardiographic PAP. The normal value of the RVTI is 0.28 +/- 0.04. An increased RVTI is associated with either left ventricular diastolic abnormalities or pulmonary hypertension. This score has no bounds. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Error|Mean
2594288|NCT02234141|Secondary|Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Tricuspid Annular Peak Sys Myocard Velocity (TAS)|TAS is an echocardiographic assessment of right ventricular function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||centimeters per second (cm/sec)||Standard Error|Mean
2594289|NCT02234141|Secondary|Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Right Ventricular Myocardial Strain (%)|Right ventricular myocardial strain is an echocardiographic assessment of right ventricular function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of strain||Standard Error|Mean
2594290|NCT02234141|Secondary|Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: TAPSE|TAPSE is an echocardiographic assessment of right ventricular function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||cm||Standard Error|Mean
2594291|NCT02234141|Secondary|Kaplan-Meier Estimate of Time to Clinical Worsening (TTCW) Evaluated in Period 1|TTCW was defined as time to the first occurrence of: death (all-cause), hospitalization for worsening pulmonary arterial hypertension (PAH) (any hospitalization for worsening PAH, lung or heart/lung transplant, atrial septostomy, or initiation of continuously infused prostanoid therapy), or disease progression (defined as both > 15% decrease from baseline in 6MWD test and WHO class III or IV symptoms at two consecutive postbaseline clinic visits separated by ≥ 14 days). TTCW was evaluated using Kaplan-Meier estimates.|Baseline up to Week 24|Participants in the Full Analysis Set were analyzed.|||days||Inter-Quartile Range|Median
2594292|NCT02234141|Secondary|Change From Baseline at Week 24 in Heart Rate Recovery (HRR) After the 6MWD Test|HRR was assessed after the 6MWD test. The HRR was calculated as the difference between the heart rate measured immediately after completing the 6MWD test and the second heart rate measured 1 minute after the 6MWD test. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.|Baseline to Week 24|Participants in the Full Analysis Set were analyzed.|||beats per minute (bpm)||Standard Error|Mean
2594293|NCT02234141|Secondary|Change From Baseline at Week 24 in emPHasis-10 Questionnaire Score|Quality of life was assessed using the emPHasis-10 questionnaire, a disease-specific self-administered 10-question questionnaire designed for routine assessment of health-related quality of life in pulmonary hypertension. Total score can range from 0 to 50, with higher scores indicating a worse quality of life. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Error|Mean
2594294|NCT02234141|Secondary|Change From Baseline at Week 24 in Short Form (SF-36) Physical Functioning Scale|Quality of life was assessed using the SF-36 questionnaire, a self-administered multi-item survey that asks 36 questions to measure functional health and well-being from the participant's point of view and consists of eight health domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health) as well as 2 summary measures (Physical Health and Mental Health). Data presented are for 1 of the domains only: Physical Functioning. Scores can range from 0 to 100, with a higher score representing a higher level of functioning. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Error|Mean
2594295|NCT02234141|Secondary|Change From Baseline at Week 24 in NT-proBNP|NT-proBNP is used to detect, diagnose, and evaluate the severity of heart failure. In general, NT-proBNP levels are higher in participants with heart failure than those who have normal heart function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.|Baseline to Week 24|Participants in the Full Analysis Set were analyzed.|||pg/mL||Standard Error|Geometric Mean
2594296|NCT02234141|Secondary|Number of Participants Experiencing Change From Baseline at Week 24 in WHO Functional Class|Class I: no symptoms with exercise or at rest. Class II: No symptoms at rest but uncomfortable and short of breath with normal activity such as climbing a flight of stairs, grocery shopping, or making the bed. Class III: May not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting (e.g., doing normal chores around the house, have to take breaks while doing activities of daily living). Class IV: Symptoms at rest and severe symptoms with any activity. Most participants also have edema in the feet and ankles as result of right heart failure. The Week 24 value was defined as the last assessment at or prior to Week 24.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||Participants|||Count of Participants
2594297|NCT02234141|Secondary|Change From Baseline at Week 24 in BDI After the 6MWD Test|Immediately following completion of the 6-minute walk test, participants were asked to assess breathlessness using the BDI score as follows: 0 = no breathlessness, 10 = extremely strong (maximal breathlessness), any number > 10 = Highest possible. Therefore, the minimum for BDI score was 0 and there was no upper bound. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.|Baseline to Week 24|Participants in the Full Analysis Set were analyzed.|||units on a scale||Standard Error|Mean
2594298|NCT02234141|Secondary|Change From Baseline at Week 24 in 6MWD Test|The 6MWD test was conducted according to the American Thoracic Society guidelines in accordance with local standard operating procedures. It measures the distance a participant is able to walk in a period of six minutes. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.|Baseline to Week 24|Participants in the Full Analysis Set were analyzed.|||meters||Standard Error|Mean
2594299|NCT02234141|Secondary|Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: Right Ventricular Cardiac Power (RVCP)|RVCP is a cardiopulmonary hemodynamic assessment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||watts||Standard Error|Mean
2594300|NCT02234141|Secondary|Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: Mixed Venous Oxygen Saturation (SVO2) (%)|SVO2 is the percentage of oxygen bound to hemoglobin in blood returning to the right side of the heart. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of oxygen saturation||Standard Error|Mean
2594301|NCT02234141|Secondary|Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: mRAP|mRAP is the mean blood pressure in the right atrium of the heart. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||mm Hg||Standard Error|Mean
2594302|NCT02234141|Secondary|Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: mPAP|mPAP is the mean blood pressure in the pulmonary artery. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||mm Hg||Standard Error|Mean
2594303|NCT02234141|Secondary|Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: Cardiac Index|Cardiac index is the amount of blood pumped by the heart, per minute, per meter square of body surface area. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.|Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||L/min/m^2||Standard Error|Mean
2594304|NCT02234141|Primary|Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24, as Measured by Right Heart Catheterization (RHC)|PVR is a measure of the extent to which pulmonary circulation resists cardiac output. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24.|Baseline to Week 24|Participants in the Full Analysis Set (all randomized participants who received ≥ 1 dose of study drug) with available data were analyzed.|||dyne*sec/cm^5||Standard Error|Mean
2594306|NCT02234115|Primary|Efficacy of Leuprolide Mesylate (LMIS 50mg)|The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) following the first injection of LMIS 50 mg from Day 28 through Day 336 (remaining duration of the study).|baseline to 28 days, 28 days to 336 days|ITT|||percentage of participants||95% Confidence Interval|Mean
2594307|NCT02234011|Primary|Observing if Ketamine May Cause a Decrease in OCD Symptoms|"Examining if ketamine is associated with a decrease in OCD symptoms as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at completion of one treatment when compared to placebo (saline solution).~The Y-BOCS measures OCD symptoms on a scale of 0-40, with higher numbers indicating greater severity of OCD symptoms. For this study, subjects had to have a Y-BOCS of greater than or equal to 18 in order to participate."|Baseline to Week 5|One subject had a screening visit, but was never enrolled in the treatment portion and therefore never had any sort of treatment analysis performed on her data.||||||
2594308|NCT02233998|Secondary|Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 2) at Week 3|Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥2 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||percentage of PI scores of >= 2||Standard Deviation|Mean
2594309|NCT02233998|Secondary|Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 3) at Week 3|Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with a PI score ≥3 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||percentage of PI scores of >= 3||Standard Deviation|Mean
2594310|NCT02233998|Secondary|Change From Baseline in the Percentage of Problem Sites (Modified Gingival Index (MGI) Scores of ≥ 3) at Week 3|Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline (i.e., Baseline Score minus Week 3 Score) in the percentage of sites with an MGI score ≥3 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||percentage of MGI scores of >= 3||Standard Deviation|Mean
2594311|NCT02233998|Secondary|Change From Baseline in the Percentage of Non-Bleeding Sites (Gingival Bleeding Index (BI) Scores of 0) at Week 3|Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was the change from baseline in the percentage of sites with a BI score of 0 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||percentage of BI scores of 0||Standard Deviation|Mean
2594312|NCT02233998|Secondary|Change From Baseline in the Percentage of Virtually Plaque-Free Sites (Plaque Index (PI) Scores of 0 or 1) at Week 3|Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was the change from baseline in the percentage of sites with a PI score of 0 or 1 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||percentage of PI scores of 0 or 1||Standard Deviation|Mean
2594341|NCT02233738|Secondary|Treatment Motivation Questionnaire (TMQ) at Baseline|"The TMQ will be used to measure self-reported interest in attending treatment Scores within each subscale are averaged~External:~Min value:1 Max value:7 External:Higher score indicates higher external reasons for attending treatment (e.g.referred to treatment by legal system)~Internal:~Min value:1 Max value:7 Internal: Higher score indicates higher internal reasons for attending treatment (e.g. personal choice to attend treatment)"|30 days prior to Baseline||||score on a scale||Standard Deviation|Mean
2605764|NCT02107014|Primary|Change in IL-1α From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2594313|NCT02233998|Secondary|Change From Baseline in the Percentage of Healthy Sites (Modified Gingival Index (MGI) Scores of 0 or 1) at Week 3|Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was the change from baseline in the percentage of sites with an MGI score of 0 or 1 at Week 3.|Baseline to 3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||percentage of MGI scores of 0 or 1||Standard Deviation|Mean
2594314|NCT02233998|Secondary|Whole Mouth Mean Gingival Bleeding Index (BI) at Week 3|Bleeding was assessed using a periodontal probe with a 0.5 mm diameter tip which was inserted into the gingival crevice, and swept from distal to mesial, around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0: Absence of bleeding after 30 seconds, 1: Bleeding after 30 seconds, and 2: Immediate bleeding. The score for each participant was calculated by averaging their tooth site scores at Week 3.|3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2594315|NCT02233998|Primary|Whole Mouth Mean Plaque Index (PI) at Week 3|Plaque area was measured based on the Turesky modification of the Quigley-Hein Plaque Index and was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual, and mesiolingual) of all scorable teeth, following disclosing, according to the following scale: 0: No plaque, 1: Separate flecks or discontinuous band of plaque at the gingival (cervical) margin, 2: Thin (up to 1 mm), continuous band of plaque at the gingival margin, 3: Band of plaque wider than 1 mm but less than 1/3 of surface, 4: Plaque covering 1/3 or more, but less than 2/3 of surface, 5: Plaque covering 2/3 or more of surface. The score for each participant was calculated by averaging their tooth site scores at Week 3.|3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2594316|NCT02233998|Primary|Whole Mouth Mean Modified Gingival Index (MGI) at Week 3|Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth according to the following scale: 0: Normal (absence of inflammation), 1: Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, 2: Mild inflammation of the entire gingival unit, 3: Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit, and 4: Severe inflammation marked redness, edema and/ or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. The score for each participant was calculated by averaging their tooth site scores at Week 3.|3 Weeks|Analysis was based on the Full Analysis Set, which included all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2594317|NCT02233985|Secondary|Frequency of Complications of the Disease Itself|The presence or absence of clinical data to warrant dehydration of hydration, infected by bacteria, pneumothorax, interstitial emphysema and subcutaneous be evaluated.|Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.||2017-05-31|05/2017||||
2594318|NCT02233985|Secondary|Hospital Readmission|After the first admission of each patient will be evaluated during the next 30 days, if a patient is readmitted for any respiratory disease, respiratory distress, pneumonia or bronchiolitis. Considering as non-serious risks that do not compromise life, tachycardia, tremor, increased access to cough immediately to the inhalation, as well as the ardor of nasal mucosa, all these with limited characteristics, however, these do not put at risk The health of the patient, so they were not measured.|Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.||2017-05-31|05/2017||||
2594319|NCT02233985|Primary|Hours of Hospital Stay|Each patient record the time of entry and measured the total hospital stay time in hours, recording the time of discharge to determine the total stay in hours. The hospital stay will be evaluated in hours. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.|Throughout the stay for each patient until discharge. Follow-up will be continued for a period of 30 days in which they may present readmissions, complications or adverse effects.|All patients included in the study, underwent measurement of hours of hospital stay from admission to pediatric emergencies to hospital discharge.|||hours||95% Confidence Interval|Median
2594320|NCT02233985|Primary|Score Respiratory Distress|It is a validated clinical scale, sufficiently reliable measure of Severity of the respiratory distress. It consists of the summation score of the sibilance / crackling parameters (the largest of them), respiratory effort, pulmonary air inlet, oxygen saturation, heart rate and breathing rate. It is stratified into 3 levels of severity: mild from 0 to 5 points, moderate from 6 to 10 and severe from 10 to 16.|Basal, 30 minutes after the end of the first 3 continuous nebulization sessions, at 4 hours, 8 hours and every 24 hours during the entire hospital stay|All patients with respiratory distress in moderate to severe stage until a stage of mild respiratory distress or difficulty breathing submitted.|||units on a scale||95% Confidence Interval|Median
2594321|NCT02233842|Primary|Time From Cancer Diagnosis to the Date of the Interview|Patients diagnosed with cancer who participated in the Cancer Patient Tobacco Use Questionnaire (C-TUQ).|up to 24 years||||years||Full Range|Median
2594322|NCT02233842|Primary|Number of Current and Former Smokers Who Smoked Cigarettes at the Time of Their Cancer Diagnosis|Current and former smokers who were smoking at the time of their cancer diagnosis.|Day 1 of interview||||participants|||Number
2606280|NCT02101515|Other Pre-specified|Neonatal Length of Stay (Neonate)|one neonate was analyzed per mother|until neonatal discharge, usually < 5 days||||days||Standard Deviation|Mean
2594325|NCT02233803|Secondary|Change From BL in Asthma Control Test (ACT) at 4 Wks for Each TP|ACT was basically a five item questionnaire, to measure participant's asthma control. It comprised of five possible answers to each question, associated with a score of 1 to 5 (1=poor control and 5=good control), wherein the scores from each question were summed to give an overall score (5=poor control and 25=complete control). ACT was recommended during each visit and was completed by the participant before any procedures were performed, avoiding any influence of the participants response. Change from BL was analysed using mixed effects ANCOVA model fitting terms for subject-level (SL) BL, Adjusted period-specific(PS) BL, treatment group and period, with participant as random effect. PS BL value, is pre-dose assessment collected on D1 of each TP. SL BL, is arithmetic mean of PS BL values of participant. Participants with an ACT below 15 were excluded from the study.|BL up to W4 (each TP)|ITT population. Only those participants with data available at the indicated time points were analyzed.|||units on scale||Standard Error|Least Squares Mean
2594326|NCT02233803|Secondary|FEV1 Area Under the Curve (AUC) (0-10 h) at D1 of Each TP|FEV1 is the maximal amount of air that can be forcefully exhaled in one second. FEV1 AUC (0 to 10h) was measured at beginning of each TP. AUC was derived using values observed at the following timepoints: 0 minute (pre-morning dosing), 5 minutes (m), 15m, 30m, 1, 2, 5, and 10h; post morning dosing FEV1 values on D1 of each TP. Pre-dose was taken as, 0h timepoint on the visit of interest, and all subsequent timepoints were calculated relative to that timepoint. FEV1 AUC was analysed using mixed effects ANCOVA model fitting terms for subject-level (SL) BL, Adjusted period-specific(PS) BL, treatment group and period, with participant as random effect.|(0-10 h) at D1 (each TP)|ITT population. Only those participants with data available at the indicated time points were analyzed.|||L*hrs||Standard Error|Least Squares Mean
2594327|NCT02233803|Primary|Change From Baseline (BL) in Trough Morning Forced Expiratory Volume in One Second (FEV1) at Day (D)29|FEV1 is maximal amount of air, forcefully exhaled in one second. Trough FEV1 is defined as morning prebronchodilator and predose: 12 hours (h) after last evening dose D28 at end of each TP. Measured by spirometer in morning, before using bronchodilator and pre-dosing at wk1 D1 and wk4 D29 of each TP and test was performed within 30 minutes prior to dosing. Change from BL was analysed using mixed effects ANCOVA model fitting terms for subject-level (SL) BL, Adjusted period-specific (PS) BL, treatment group and period, with participant as random effect. PS BL value is pre-dose assessment collected on D1 of each TP. SL BL is arithmetic mean of PS BL values of participant. If only one of PS BL value is missing for participant, SL BL took value of other BL. If both PS BL values were missing, SL BL was set to missing. Period level BL=PS BL - associated SL BL.|BL (D1) and D29 (each TP)|The intent to treat (ITT) population comprised of all randomized participants who received at least one dose of study treatment. This population was based on the treatment to which the participant was randomized. Only those participants with data available at the indicated time points were analyzed.|||Litre (L)||Standard Error|Least Squares Mean
2594328|NCT02233751|Secondary|Vd/F (L)|Vd/F (L) = Apparent volume of distribution|168 hours||||Liters||Standard Deviation|Mean
2594329|NCT02233751|Secondary|Clearance CL/F (L/hr)|Clearance - volume of plasma from which TT/TE is completely removed per unit time|168 hours||||L/hr||Standard Deviation|Mean
2594330|NCT02233751|Secondary|Half-life (t 1/2)(hr)|t 1/2 = Half-life is the time required for a concentration to reduce to half its initial value|168 hours||||hours||Standard Deviation|Mean
2594331|NCT02233751|Secondary|Time to Maximum Concentration (Tmax)(hr)|tmax = Time to reach maximum concentration|The sample time of Cmax during a 168 hour sampling interval||||hours||Standard Deviation|Mean
2594332|NCT02233751|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity|AUC(0-inf) (ng⋅hr/dL) = area under the concentration-time curve from time zero to infinity|time zero to infinity||||(ng⋅hr/dL)||Standard Deviation|Mean
2594333|NCT02233751|Primary|Area Under the Concentration-time Curve From Time Zero to Time t|AUC(0-168h) (ng⋅hr/dL) = area under the concentration-time curve from time zero to Day 8 (1 week);|168 hrs||||(ng⋅hr/dL)||Standard Deviation|Mean
2594334|NCT02233751|Primary|Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate|Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate|Maximum serum concentrations occurring during an 8 days study window|Healthy normal male volunteers|||ng/dL||Standard Deviation|Mean
2594335|NCT02233738|Secondary|Helping Alliance Questionnaire - Total Score|"Participant completed assessment on the final day of group and rated therapist based on their interactions over the 4 days.~Min:19 Max:114 Higher score indicates stronger alliance with therapist"|Completed during session 4 of treatment group (i.e. the final treatment session)||||score on a scale||Standard Deviation|Mean
2594336|NCT02233738|Secondary|Psychiatric Outpatient Satisfaction Scale - Total Score|Min:13 Max:65 Higher score indicates better satisfaction|1 month||||score on a scale||Standard Deviation|Mean
2594337|NCT02233738|Secondary|Fagerstrom Test for Nicotine Dependence at Baseline|Min:0 Max:10 Higher score indicates higher level of nicotine dependence|30 days prior to Baseline||||score on a scale||Standard Deviation|Mean
2594338|NCT02233738|Secondary|Treatment Motivation Questionnaire (TMQ) at 6-months|"The TMQ will be used to measure self-reported interest in attending treatment Scores within each subscale are averaged~External:~Min value:1 Max value:7 External:Higher score indicates higher external reasons for attending treatment (e.g.referred to treatment by legal system)~Internal:~Min value:1 Max value:7 Internal: Higher score indicates higher internal reasons for attending treatment (e.g. personal choice to attend treatment)"|90 days prior to 6-month follow-up||||score on a scale||Standard Deviation|Mean
2594339|NCT02233738|Secondary|Treatment Motivation Questionnaire (TMQ) at 3-month|"The TMQ will be used to measure self-reported interest in attending treatment Scores within each subscale are averaged~External:~Min value:1 Max value:7 External:Higher score indicates higher external reasons for attending treatment (e.g.referred to treatment by legal system)~Internal:~Min value:1 Max value:7 Internal: Higher score indicates higher internal reasons for attending treatment (e.g. personal choice to attend treatment)"|60 days prior to 3-month follow-up||||score on a scale||Standard Deviation|Mean
2594340|NCT02233738|Secondary|Treatment Motivation Questionnaire (TMQ) at 1-month|"The TMQ will be used to measure self-reported interest in attending treatment Scores within each subscale are averaged~External:~Min value:1 Max value:7 External:Higher score indicates higher external reasons for attending treatment (e.g.referred to treatment by legal system)~Internal:~Min value:1 Max value:7 Internal: Higher score indicates higher internal reasons for attending treatment (e.g. personal choice to attend treatment)"|30 days prior to 1-month follow-up||||score on a scale||Standard Deviation|Mean
2594367|NCT02233738|Secondary|Addiction Severity Index-Lite (ASI-Lite) at 3 Month for Psychiatric Status|The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity|3 months||||score on a scale||Standard Deviation|Mean
2594368|NCT02233738|Secondary|Addiction Severity Index-Lite (ASI-Lite) at 1 Month for Psychiatric Status|The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity|30 days||||score on a scale||Standard Deviation|Mean
2594369|NCT02233738|Secondary|Addiction Severity Index-Lite (ASI-Lite) at Baseline for Psychiatric Status|The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity|30 days prior to Baseline||||score on a scale||Standard Deviation|Mean
2594370|NCT02233738|Secondary|Addiction Severity Index-Lite (ASI-Lite) at 6 Months for Alcohol Use|The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity|6 months||||score on a scale||Standard Deviation|Mean
2594371|NCT02233738|Secondary|Addiction Severity Index-Lite (ASI-Lite) at 3 Months for Alcohol Use|The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity|3 months||||score on a scale||Standard Deviation|Mean
2594372|NCT02233738|Secondary|Addiction Severity Index-Lite (ASI-Lite) at 1 Month for Alcohol Use|The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity|1 month||||score on a scale||Standard Deviation|Mean
2594373|NCT02233738|Secondary|Addiction Severity Index-Lite (ASI-Lite) at Baseline for Alcohol Use|The ASI-Lite will be used to measure addiction severity Min value:0 Max value: 1 Higher score indicates greater problem severity|30 days prior to Baseline|The ASI-Lite measures addiction severity|||score on a scale||Standard Deviation|Mean
2594374|NCT02233738|Secondary|Substance Use Disorder and Mental Health Treatment Sessions at 6 Months|This specific measure combined the number substance use disorder treatment sessions and mental health treatment sessions attended for the 90 days prior to 6-month follow-up.|6 Months||||sessions||Inter-Quartile Range|Mean
2594375|NCT02233738|Secondary|Substance Use Disorder and Mental Health Treatment Sessions at 3 Months|This specific measure combined the number substance use disorder treatment sessions and mental health treatment sessions attended for the 60 days prior to 3-month follow-up.|3 Months||||sessions||Inter-Quartile Range|Mean
2594376|NCT02233738|Secondary|Substance Use Disorder and Mental Health Treatment Sessions at 1 Month|This specific measure combined the number substance use disorder treatment sessions and mental health treatment sessions attended for the 30 days prior to 1-month follow-up.|1 Month||||sessions||Inter-Quartile Range|Mean
2594377|NCT02233738|Secondary|Substance Use Disorder and Mental Health Treatment Sessions at Baseline|This specific measure combined the number substance use disorder treatment sessions and mental health treatment sessions attended for the 30 days prior to Baseline.|30 days prior to Baseline||||sessions||Inter-Quartile Range|Mean
2594378|NCT02233738|Secondary|Mental Health Treatment Sessions at 6 Months|A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Computerized Patient Record System for the 90 days prior to 6-month follow-up. Treatment sessions included individual sessions with outpatient mental health staff.|6 Months||||sessions||Inter-Quartile Range|Mean
2594379|NCT02233738|Secondary|Mental Health Treatment Sessions at 3 Months|A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Computerized Patient Record System for the 60 days prior to 3-month follow-up. Treatment sessions included individual sessions with outpatient mental health staff.|3 Months||||sessions||Inter-Quartile Range|Mean
2594380|NCT02233738|Secondary|Mental Health Treatment Sessions at 1 Month|A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Computerized Patient Record System for the 30 days prior to 1-month follow-up. Treatment sessions included individual sessions with outpatient mental health staff.|1 Month||||sessions||Inter-Quartile Range|Mean
2594381|NCT02233738|Secondary|Mental Health Treatment Sessions at Baseline|A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Computerized Patient Record System for the 30 days prior to Baseline. Treatment sessions included individual sessions with outpatient mental health staff.|30 days prior to Baseline||||sessions||Inter-Quartile Range|Mean
2594382|NCT02233738|Primary|Days Involved in Productive Work Activities at 6 Months|A calendar was used to record the number of times a participant participated in a productive work activity (e.g. volunteered or worked at a job) in the 90 days prior to 6-month follow-up.|6 months||||# of days||Inter-Quartile Range|Mean
2594383|NCT02233738|Primary|Days Involved in Productive Work Activities at 3 Months|A calendar was used to record the number of times a participant participated in a productive work activity (e.g. volunteered or worked at a job) in the 60 days prior to 3-month follow-up|3 months||||# of days||Inter-Quartile Range|Mean
2594384|NCT02233738|Primary|Days Involved in Productive Work Activities at 1 Month|A calendar was used to record the number of times a participant participated in a productive work activity (e.g. volunteered or worked at a job) in the 30 days prior to 1-month follow-up.|1 month||||# of days||Inter-Quartile Range|Mean
2594385|NCT02233738|Primary|Days Involved in Productive Work Activities at Baseline|A calendar was used to record the number of times a participant participated in a productive work activity (e.g. volunteered or worked at a job) in the 30 days prior to Baseline.|30 days prior to Baseline||||# of days||Inter-Quartile Range|Mean
2594386|NCT02233738|Primary|Times Involved in Community Participation Activities at 6 Months|A calendar was used to record the number of times a participant participated in an activity in the community (e.g. museum, library, baseball game) in the 90 days prior to 6-month follow-up.|6 months||||# of times activity completed||Inter-Quartile Range|Mean
2594387|NCT02233738|Primary|Times Involved in Community Participation Activities at 3 Months|A calendar was used to record the number of times a participant participated in an activity in the community (e.g. museum, library, baseball game) in the 60 days prior to 3-month follow-up.|3 months||||# of times activity completed||Inter-Quartile Range|Mean
2596903|NCT02203578|Secondary|Total Duration of Immunosuppressive Therapy||Up to 12 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.||||||
2594388|NCT02233738|Primary|Times Involved in Community Participation Activities at 1 Month|A calendar was used to record the number of times a participant participated in an activity in the community (e.g. museum, library, baseball game) in the 30 days prior to 1-month follow-up.|1 month||||# of time activity completed||Inter-Quartile Range|Mean
2594389|NCT02233738|Primary|Times Involved in Community Participation Activities at Baseline|A calendar was used to record the number of times a participant participated in an activity in the community (e.g. museum, library, baseball game) in the 30 days prior to Baseline.|30 days prior to Baseline||||# of times activity completed||Inter-Quartile Range|Mean
2594390|NCT02233738|Primary|Twelve-Step Sessions Attended at 6 Months|A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended in the 90 days prior to 6-month follow-up.|6 months||||Sessions||Inter-Quartile Range|Mean
2594391|NCT02233738|Primary|Twelve-Step Sessions Attended at 3 Months|A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended 60 days prior to 3-month follow-up.|3 months||||Sessions||Inter-Quartile Range|Mean
2594392|NCT02233738|Primary|Twelve-Step Sessions Attended at 1 Month|A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended 30 days prior to 1-month follow-up.|1 month||||Sessions||Inter-Quartile Range|Mean
2594393|NCT02233738|Primary|Twelve-Step Sessions Attended at Baseline|A Treatment Attendance Calendar was used to record the number of self-reported 12-step sessions attended 30 days prior to Baseline.|30 days prior to Baseline||||Sessions||Inter-Quartile Range|Mean
2594394|NCT02233738|Primary|Substance Use Disorder Treatment Sessions at 6 Months|A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Computerized Patient Record System for the 60 days prior to 6-month follow-up. Treatment sessions included the outpatient substance use disorder treatment group sessions and individual sessions.|6 months||||Sessions||Inter-Quartile Range|Mean
2594395|NCT02233738|Primary|Substance Use Disorder Treatment Sessions at 3 Months|A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Computerized Patient Record System for the 60 days prior to 3-month follow-up. Treatment sessions included the outpatient substance use disorder treatment group sessions and individual sessions.|3 months||||Sessions||Inter-Quartile Range|Mean
2594396|NCT02233738|Primary|Substance Use Disorder Treatment Sessions at 1 Month|A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Computerized Patient Record System for the 30 days prior to 1-month follow-up. Treatment sessions included the outpatient substance use disorder treatment group sessions and individual sessions.|1 month||||Sessions||Inter-Quartile Range|Mean
2594397|NCT02233738|Primary|Substance Use Disorder Treatment Sessions at Baseline|A Treatment Attendance Calendar was used to record the number of objective treatment sessions documented in each participants VA Computerized Patient Record System for the 30 days prior to Baseline. Treatment sessions included the outpatient substance use disorder treatment group sessions and individual sessions.|30 days prior to Baseline||||Sessions||Inter-Quartile Range|Mean
2594398|NCT02233738|Primary|Illicit Drug Use Days at 6 Months|The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-month follow-up. This measure represents the number of illicit drug use days within the stated time period.|6 months||||Days||Inter-Quartile Range|Mean
2594399|NCT02233738|Primary|Illicit Drug Use Days at 3 Months|The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-month follow-up. This measure represents the number of illicit drug use days within the stated time period.|3 months||||Days||Inter-Quartile Range|Mean
2594400|NCT02233738|Primary|Illicit Drug Use Days at 1 Month|The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to 1-month follow-up. This measure represents the number of illicit drug use days within the stated time period.|1 month||||Days||Inter-Quartile Range|Mean
2594401|NCT02233738|Primary|Illicit Drug Use Days at Baseline|The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of drug use in the 30 days prior to Baseline. This measure represents the number of illicit drug use days within the stated time period.|30 days prior to Baseline||||Days||Inter-Quartile Range|Mean
2594402|NCT02233738|Primary|Binge Drink Days at 6 Months|The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-month follow-up. This measure represents the number of days the participant binge drank (5 or more standard drinks on a single day for males; 4 or more standard drinks on a single day for females) within the stated time period.|6 months||||Days||Inter-Quartile Range|Mean
2594403|NCT02233738|Primary|Binge Drink Days at 3 Months|The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-month follow-up. This measure represents the number of days the participant binge drank (5 or more standard drinks on a single day for males; 4 or more standard drinks on a single day for females) within the stated time period.|3 months||||Days||Inter-Quartile Range|Mean
2594404|NCT02233738|Primary|Binge Drink Days at 1 Month|The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to 1-month follow-up. This measure represents the number of days the participant binge drank (5 or more standard drinks on a single day for males; 4 or more standard drinks on a single day for females) within the stated time period.|1 month||||Days||Inter-Quartile Range|Mean
2594405|NCT02233738|Primary|Binge Drink Days at Baseline|The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to Baseline. This measure represents the number of days the participant binge drank (5 or more standard drinks on a single day for males; 4 or more standard drinks on a single day for females).|30 days prior to Baseline||||Days||Inter-Quartile Range|Mean
2594406|NCT02233738|Primary|Alcohol Drink Days at 6 Months|The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-month follow-up. This measure represents the number of days any alcohol was consumed within the stated time period.|6 months||||Days||Inter-Quartile Range|Mean
2595213|NCT02224755|Secondary|Rehospitalizations|Rate of all cause rehospitalization|From initial discharge to two years post-implant|Analysis population only includes Subjects who were discharged on LVAD support from the implant hospitalization|||events per patient year|||Number
2594407|NCT02233738|Primary|Alcohol Drink Days at 3 Months|The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-month follow-up. This measure represents the number of days any alcohol was consumed within the stated time period.|3 months||||Days||Inter-Quartile Range|Mean
2594408|NCT02233738|Primary|Alcohol Drink Days at 1 Month|The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days after day 1 of the treatment group. This measure represents the number of days any alcohol was consumed within the stated time period.|1 month||||Days||Inter-Quartile Range|Mean
2594409|NCT02233738|Primary|Alcohol Drink Days at Baseline|The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to Baseline. This measure represents the number of days any alcohol was consumed within the stated time period.|30 days prior to Baseline||||days||Inter-Quartile Range|Mean
2594410|NCT02233738|Primary|Peak SEC at 6 Months|The 6-month follow-up was conducted 90 days after the 3-month follow-up. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-month follow-up. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents the most standard drinks consumed on a single day within the stated time period.|6 months||||Standard Ethanol Content Units||Inter-Quartile Range|Mean
2594411|NCT02233738|Primary|Peak SEC at 3 Months|The 3-month follow-up was conducted 60 days after the 1-month follow-up. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-month follow-up. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents the most standard drinks consumed on a single day within the stated time period.|3 months||||Standard Ethanol Content Units||Inter-Quartile Range|Mean
2594412|NCT02233738|Primary|Peak SEC at 1 Month|The 1-month follow-up was conducted 30 days after day 1 of the treatment group. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to 1-month follow-up. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents the most standard drinks consumed on a single day within the stated time period.|1 month||||Standard Ethanol Content Units||Inter-Quartile Range|Mean
2594413|NCT02233738|Primary|Peak SEC at Baseline|The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to baseline. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents the most standard drinks consumed in a single day within the stated time period.|30 days prior to Baseline||||Standard Ethanol Content Units||Inter-Quartile Range|Mean
2594414|NCT02233738|Primary|Standard Ethanol Content Units (SECs) at 6 Months|The 6-month follow-up was conducted 90 days after the 3-month follow-up. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 90 days prior to 6-month follow-up. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents ALL standard drinks consumed within the stated time period.|6 months||||Standard Ethanol Content Units||Inter-Quartile Range|Mean
2594415|NCT02233738|Primary|Standard Ethanol Content Units (SECs) at 3 Months|The 3-month follow-up was conducted 60 days after the 1-month follow-up. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 60 days prior to 3-month follow-up. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents ALL standard drinks consumed within the stated time period.|3 months||||Standard Ethanol Content Units||Inter-Quartile Range|Mean
2594416|NCT02233738|Primary|Standard Ethanol Content Units (SECs) at 1 Month|The 1-month follow-up was conducted 30 days after day 1 of the treatment group. The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to 1-month follow-up. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents ALL standard drinks consumed within the stated time period.|1 month||||Standard Ethanol Content Units||Inter-Quartile Range|Mean
2594417|NCT02233738|Primary|Standard Ethanol Content Units (SECs) Baseline|The Timeline Follow-Back (TLFB) calendar was used to assess retrospective self-report of alcohol in the 30 days prior to baseline. Amount of alcohol consumption was converted to standard ethanol content units (SECs; or standard drinks) equivalent to 0.5 oz. of ethanol. This measure represents ALL standard drinks consumed within the stated time period.|30 days prior to Baseline||||Standard Ethanol Content Unit||Inter-Quartile Range|Mean
2594418|NCT02233647|Secondary|"Peak Ratings of Talkative/Friendly on the Visual Analog Scale"|"Subjects rated their feelings of Talkative/Friendly on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594419|NCT02233647|Secondary|"Peak Ratings of Willing to Take Again on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Take Again on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594420|NCT02233647|Secondary|"Peak Ratings of Stimulated on the Visual Analog Scale"|"Subjects rated their feelings of Stimulated on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594421|NCT02233647|Secondary|"Peak Ratings of Sluggish/Fatigued/Lazy on the Visual Analog Scale"|"Subjects rated their feelings of Sluggish/Fatigued/Lazy on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594422|NCT02233647|Secondary|"Peak Ratings of Shaky/Jittery on the Visual Analog Scale"|"Subjects rated their feelings of Shaky/Jittery on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594423|NCT02233647|Secondary|"Peak Ratings of Rush on the Visual Analog Scale"|"Subjects rated their feelings of Rush on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594424|NCT02233647|Secondary|"Peak Ratings of Restless on the Visual Analog Scale"|"Subjects rated their feelings of Restless on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594425|NCT02233647|Secondary|"Peak Ratings of Performance Improved on the Visual Analog Scale"|"Subjects rated their feelings of Performance Improved on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594426|NCT02233647|Secondary|"Peak Ratings of Performance Impaired on the Visual Analog Scale"|"Subjects rated their feelings of Performance Impaired on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594427|NCT02233647|Secondary|"Peak Ratings of Willing to Pay For on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Pay For on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594428|NCT02233647|Secondary|"Peak Ratings of Nervous/Anxious on the Visual Analog Scale"|"Subjects rated their feelings of Nervous/Anxious on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594429|NCT02233647|Secondary|"Peak Ratings of Nauseated/Queasy/Sick to Stomach on the Visual Analog Scale"|"Subjects rated their feelings of Nauseated/Queasy/Sick to Stomach on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594430|NCT02233647|Secondary|"Peak Ratings of Like Drug on the Visual Analog Scale"|"Subjects rated their feelings of Like Drug on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594431|NCT02233647|Secondary|"Peak Ratings of Irregular/Racing Heartbeat on the Visual Analog Scale"|"Subjects rated their feelings of Irregular/Racing Heartbeat on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594432|NCT02233647|Secondary|"Peak Ratings of High on the Visual Analog Scale"|"Subjects rated their feelings of High on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594433|NCT02233647|Secondary|"Peak Ratings of Good Effect on the Visual Analog Scale"|"Subjects rated their feelings of Good Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594434|NCT02233647|Secondary|"Peak Ratings of Euphoric on the Visual Analog Scale"|"Subjects rated their feelings of Euphoric on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594435|NCT02233647|Secondary|"Peak Ratings of Bad Effect on the Visual Analog Scale"|"Subjects rated their feelings of Bad Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594436|NCT02233647|Secondary|"Peak Ratings of Any Effect on the Visual Analog Scale"|"Subjects rated their feelings of Any Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594437|NCT02233647|Secondary|"Peak Ratings of Active, Alert, Energetic on the Visual Analog Scale"|"Subjects rated their feelings of Active, Alert, Energetic on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594438|NCT02233647|Secondary|Peak Score on Stimulant Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Stimulant Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 stimulant items was summed to yield the Stimulant Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594439|NCT02233647|Secondary|Peak Score on Sedative Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Sedative Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Sedative Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo conditions."|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2594440|NCT02233647|Primary|Peak Temperature|Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||Degrees Fahrenheit||Standard Error|Mean
2594441|NCT02233647|Primary|Peak Heart Rate|Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||Beats per Minute||Standard Error|Mean
2594442|NCT02233647|Primary|Peak Diastolic Pressure|Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||mm Hg||Standard Error|Mean
2594443|NCT02233647|Primary|Peak Systolic Pressure|Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both phendimetrazine and placebo maintenance conditions.|This measure was completed at 15 minute intervals after sampling each cocaine dose under both phendimetrazine and placebo maintenance conditions.||||mm Hg||Standard Error|Mean
2594444|NCT02233543|Secondary|Percent of Time Spent During the Night Below 90 % in Blood Oxygen Saturation|The time during the night spent below 90 % in blood oxygen saturation following 4 weeks administration of QVA149 compared to placebo was assessed. Night time oxygenation (SpO2) was measured using polygraphy.|Post 4 weeks administration of QVA149, post 4 weeks administration of placebo|Only randomized participants with data from both treatments were analyzed.|||Percent||Standard Error|Least Squares Mean
2594445|NCT02233543|Primary|Mean Night-time Blood Oxygenation|The mean night-time blood oxygenation following 4 weeks administration of QVA149 compared to placebo was assessed. Night time oxygenation (SpO2) was measured using polygraphy.|Post 4 weeks administration of QVA149, post 4 weeks administration of placebo|Only randomized participants with data from both treatments were analyzed.|||Percent Oxygenation||Standard Error|Least Squares Mean
2594446|NCT02233517|Other Pre-specified|The Drug Abuse Screening Test (DAST)|"The DAST contains 20 yes/no questions about behavior and symptoms pertaining to substance use. Scale range is 0-20, with higher scores reflecting greater impairment."|pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks)|Last observation carried forward analyses used; 36 participants assigned to groups. Data screening found one participant's data (male, CBT arm) were not valid; 35 participants' data analyzed. For one participant (female, PCT), data was available only for 6 month follow-up.|||units on a scale||Standard Deviation|Mean
2594447|NCT02233517|Other Pre-specified|The Alcohol Use Disorder Identification Test (AUDIT)|The AUDIT contains 10 multiple choice questions about behavior and symptoms related to alcohol consumption. Scale scores range from 0 to 40, with higher scores reflecting greater impairment. Scores over 8 reflect a strong likelihood of hazardous our harmful alcohol consumption.|pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)|Last observation carried forward analyses used; 36 participants assigned to groups. Data screening found one participant's data (male, CBT arm) were not valid; 35 participants' data analyzed.|||units on a scale||Standard Deviation|Mean
2594448|NCT02233517|Other Pre-specified|PTSD Checklist (PCL)|On the PCL participants first report an autobiographical narrative of a trauma, and subsequently rate symptom frequency (0 [not at all] - 4 [everyday]) and severity (0 [not at all distressing] - 4 [extremely distressing]) for all DSM-V PTSD symptoms within the past week. The PCL will be administered weekly to evaluate the association of PTSD symptoms with anger cognitions (as measured by the DAR) over the course of the group. Total score ranges from 0 to 80, with higher scores reflecting greater impairment.|pre-treatment (baseline), post-treatment (12 weeks)|Last observation carried forward analyses used; 36 participants assigned to groups. Data screening found one participant's data (male, CBT arm) were not valid; 35 participants' data analyzed.|||units on a scale||Standard Deviation|Mean
2594449|NCT02233517|Other Pre-specified|The Adaptability Scale of the Connor-Davidson Resilience Scale (CD-RISC)|"The Adaptability Scale is an 8-item subscale of the CD-RISC that measures adaptability in the face of challenges (e.g., I am able to adapt when changes occur). Cronbach's alpha for the 8-item Adaptability scale was found to be .91 in a sample of 1981Veterans (Green et al, under review). One of the primary goals of the CBT-A intervention is to increase Veterans' behavioral repertoire and range of Activities by targeting maladaptive Thought Functions and Emotion Functions. The Adaptability scale of the CD-RISC will be included among the outcome measures as it may assess improvements in Thought Functions and Emotion Functions that underlie limitations to Activities and Participation. The Adaptability scale scores can range from 0 to 32, with higher scores reflecting better functioning."|pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)|Last observation carried forward analyses used; 36 participants assigned to groups. Data screening found one participant's data (male, CBT arm) were not valid; 35 participants' data analyzed.|||units on a scale||Standard Deviation|Mean
2594450|NCT02233517|Secondary|The McMaster Family Assessment Device (FAD)|The FAD is a 60-item scale that consists of statements about families to which respondents indicated agreement or disagreement on a 4-point scale. It yields a General Functioning (GF) score, as well as indices of 6 areas of family activity: problem solving; communication; roles; affective responses; affective involvement; and behavioral control. The General Functioning Scale will be used for this outcome. The General Functional Scale scores range from 1-4, with higher scores reflect greater impairment.|pre-treatment, post-treatment, 3 months post-treatment, 6-months post-treatment|Last observation carried forward analyses used; 36 participants assigned to groups. Data screening found one participant's data (male, CBT arm) were not valid; 35 participants' data analyzed.|||units on a scale||Standard Deviation|Mean
2594451|NCT02233517|Secondary|Change in Mean Scores on the Inventory of Psychosocial Functioning (IPF) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.|The IPF is an 80-item self-report measure that assesses functioning over the past 30 days in the following domains: romantic relationships; family relationships; work; friendships and socializing; parenting; academic pursuits; and self-care. The IPF Total score will be used in these analyses. Scores range from 11 to 80, with higher scores reflecting greater functional impairment.|pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)|Last observation carried forward analyses used; 36 participants assigned to groups. Data screening found one participant's data (male, CBT arm) were not valid; 35 participants' data analyzed.|||units on a scale||Standard Deviation|Mean
2594452|NCT02233517|Secondary|Change in Mean Scores on the World Health Organization Disability Assessment Schedule, Version 2.0 (WHO-DAS 2.0) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up.|The 12-item, self-report version of the WHO-DAS 2.0 will be administered to assess the impact of anger and aggression on broad functioning, as well as across six ICF functioning domains of mobility, self-care, getting along, life activities (household and work) and participation. In addition to the outcome time frame listed above, the WHO-DAS 2.0 will be administered weekly to collect exploratory information about Veterans' perceptions of how their overall functioning changes over the course of the group. The scale range is 0 to 48, with higher scores reflecting greater impairment.|pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)|For participants without baseline data, the data from the first (of 12) intervention sessions was used as baseline. Last observation carried forward was used for all analyses. Data screening found one participant's data (male, CBT arm) were not valid; his data was not used.|||units on a scale||Standard Deviation|Mean
2594453|NCT02233517|Secondary|Change in Mean Scores on the Community Reintegration of Service Members Computer Adaptive Test From Baseline to Post-treatment.|"The computer-adaptive version of the CRIS was developed specifically to assess the ICF domain of Participation in Veterans. The Perceived Limitations to Participation subscale assesses Veterans' perceived limitations in participation, and includes items such as I felt that I easily lost control of my feelings. The Extent of Participation subscale assesses how often Veterans experience a challenge in participation, and includes items such as How often did you get together with friends? The Satisfaction with Participation subscale assesses Veterans' level of satisfaction with participation, and includes items such as How satisfied were you with your daily accomplishments? Each of the scales has a range of 0-100, with higher scores reflecting better functioning."|pre-treatment (baseline), post-treatment (12 weeks)|Last observation carried forward analyses used. Three participants did not have baseline measures, so were not included.|||units on a scale||Standard Deviation|Mean
2594454|NCT02233517|Primary|Change in Mean Scores on the Novaco Anger Scale (NAS) From Baseline to Post-treatment, 3-month Follow-up, and 6-month Follow-up.|The NAS is a measure anger and coping that indexes four aspects of the experience of anger: Cognitive, Arousal, Behavior, and Anger Regulation. The T-score for the total NAS is used as the outcome, with a range of 0 to 100. Higher scores reflect greater impairment.|pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)|The NAS was not used with the first cohort of CBT, so the total N for this measure is 28. Last observation carried forward used to address missing data.|||units on a scale||Standard Deviation|Mean
2594455|NCT02233517|Primary|Change in Mean Scores on the Dimensions of Anger Reactions Scale (DAR) Over 16 Time Points: Baseline, 12 Treatment Sessions, Post-treatment, 3-month and 6-month Follow-up|The DAR is a 7-item scale measuring the frequency, duration, and behavioral response to anger, and anger-related functional impairment on social relationships, health, and work. The scale will be administered weekly to provide information about the pattern of change in anger- and aggression-related cognitions over the course of the group. Scores range from 0 to 56, with higher scores reflecting greater impairment.|pre-treatment (baseline), weekly treatment sessions, post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)|Last observation carried forward analyses used; 36 participants assigned to groups. Data screening found one participant's data (male, CBT arm) were not valid; 35 participants' data analyzed. Data for baseline session incomplete/unscorable for one participant (female, CBT arm); her data not included in outcome means table, so n for CBT arm is 17.|||units on a scale||Standard Deviation|Mean
2594456|NCT02233517|Primary|Change in Mean Scores on the Conflicts Tactics Scale (CTS) From Baseline to Post-treatment, 3 Month and 6 Month Follow-up.|Physically aggressive behaviors including throwing something at someone, pushing, grabbing, shoving, slapping, kicking, biting, hitting, beating up, threatening with a gun or knife, or using a gun or knife on someone. Scale range 0 (never) to 6 (more than 20 times) over past 30 days.|pre-treatment (baseline), post-treatment (12 weeks), 3 months post-treatment (48 weeks), and 6 months post-treatment (84 weeks)|Last observation carried forward analyses used; 36 participants assigned to groups. Data screening found one participant's data (male, CBT arm) were not valid; 35 participants' data analyzed. One participant (male, PCT arm) contacted, confirmed that 3 month data was invalid; data for this subject, this time point, this measure not used.|||units on a scale||Standard Deviation|Mean
2594457|NCT02233478|Primary|Plasma Ellagic Acid Concentration 0 to 24 Hours Post-dose Area Under the Curve|Blood samples were collected at baseline, 0.5, 1, 2, 3, 4, 6 and 24 h after ingestion of pomegranate juice (PJ) alone, or PJ mixed with soy protein, or PJ mixed with soybean flour. Plasma concentration of ellagic acid at each time point was determined to create a pharmacokinetic parameter area under the curve.|Baseline, 0.5, 1, 2, 3, 4, 6 and 24 hr after 1 dosing of each intervention during the 3-week period|All participants for whom plasma ellagic acid was determined at baseline, 0.5, 1, 2, 3, 4, 6 and 24 hr after 1 dosing of PJ, or PJ with soy protein, or PJ with soybean flour|||micromol*h/L||Standard Deviation|Mean
2594458|NCT02233309|Primary|Pressure in the Caudal Epidural Space|After administration of the single-shot bolus dose of the local anesthetic agent (1 mL/kg), the immediate post-bolus pressure was measured.|Immediately post bolus|Due to errors in data collection or protocol violations, 5 patients were excluded leaving 31 patients for analysis.|||mmHg||Standard Deviation|Mean
2594459|NCT02233296|Primary|Pharmacokinetics - AUC0-inf (ng.h/mL)|This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).|Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)|"all participants with evaluable PK data according to the following criteria:~completion of both treatment regimens,~availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),~absence of any important protocol deviation that would have rendered the data incomparable between treatments"|||ng.h/mL||Standard Deviation|Mean
2594460|NCT02233296|Primary|Pharmacokinetics - AUC0-t (ng.h/mL)|This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).|Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)|"all participantss with evaluable PK data according to the following criteria:~completion of both treatment regimens,~availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),~absence of any important protocol deviation that would have rendered the data incomparable between treatments"|||ng.h/mL||Standard Deviation|Mean
2594461|NCT02233296|Secondary|Tolerability|Tolerability was defined as the number of participants that did not withdraw from the study early due to adverse events.|15 days|All the participants included in the study who received at least one dose of lasmiditan (n=30). Participant disposition was considered for all participants under the fed condition and then all participants under the fasted condition not per sequence of dosing (fed/fasted or fasted/fed).|||participants|||Number
2594462|NCT02233296|Secondary|Safety. Safety Measurements Include Physical Exams, Vital Signs, ECGs, Clinical Laboratory Assessments, AEs, Columbia Suicide Severity Rating Scale (C-SSRS).|Safety was evaluated in all participants (n=30) under the fasted condition and the fed condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed). The number of unique subjects with an AE and the number of events are provided.|Duration of study- From Screening (signing informed consent form) to End-of-Study ~ 15 days|All the participants included in the study who received at least one dose of lasmiditan (n=30). Adverse events were considered in all participants under the fed condition and then in all participants under the fasted condition not per sequence of dosing (fed/fasted or fasted/fed).|||participants with adverse events|||Number
2594463|NCT02233296|Primary|Pharmacokinetics - Tmax (Hours)|This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).|Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)|"all participants with evaluable PK data according to the following criteria:~completion of both treatment regimens,~availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),~absence of any important protocol deviation that would have rendered the data incomparable between treatments"|||hours||Standard Deviation|Mean
2594464|NCT02233296|Primary|Pharmacokinetics - Cmax (ng/mL)|This study was designed to estimate the relative bioavailability of lasmiditan 200 mg in the fed state relative to the fasted state. For each primary pharmacokinetic endpoint, i.e., Area under concentration curve (time zero to last, time zero to infinity), Maximum concentration, point estimates and corresponding 90% confidence intervals were constructed. Duration of the study was approximately 5 weeks, including up to 3 weeks for screening and 16 days on study (2 - 3 day dosing periods, 6 day washout period and follow-up).|Sequential timepoints on each dosing day pre-dose to 30 h (timepoints - pre-dose and then 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 and 30 hours post dose)|"all participants with evaluable PK data according to the following criteria:~completion of both treatment regimens,~availability of measurements of the primary PK variable(s) for both treatments (Cmax and AUC0-inf or AUC0-t),~absence of any important protocol deviation that would have rendered the data incomparable between treatments"|||ng/mL||Standard Deviation|Mean
2594465|NCT02233101|Secondary|Other Complications|"Any other complications listed below:~DVT or PE~Return to the OR within 30 days~Re-admission within 30 days~Superficial infection~Deep infection~Periprosthetic fracture~Cerebrovascular accident or Transient ischemic attack~Dislocation"|participants will be followed for the duration of hospital stay, an expected average of no more than 30 days||||participants|||Number
2594466|NCT02233101|Primary|Number of Participants Who Required Blood Transfusion|Patient hemoglobin will be measured during and after surgery for the first 24 hours to determine if a blood transfusion is indicated.|during or within 24 hours after surgery||||participants|||Number
2594467|NCT02232984|Secondary|Delivery System Comparison Between ACUITY Pro and the Other Delivery Systems|Characterize the performance of the BSC ACUITY Pro delivery system versus competitive delivery systems in the placement of LV leads. Data collected on the use of the ACUITY Pro delivery system and competitive systems were characterized by presenting summary statistics by system (all competitive devices maybe combined for purposes of reporting), and differences between the ACUITY Pro system and competitive systems were reported as appropriate.|At time of implantation (0 to 30 days post consent signature)||||Minutes||Standard Deviation|Mean
2594468|NCT02232984|Secondary|Final Sensing Amplitude at Pre-discharge|Characterize the electrical performance of BSC pacing vectors using sensing amplitudes. Summary statistics were provided for LV Tip 1 to LV Ring 2 measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.|Pre-discharge (up to 7 days post implant)||||Milivolts||Standard Deviation|Mean
2594469|NCT02232984|Secondary|Final LV Lead Impedance at Pre-discharge|Characterize the electrical performance of BSC pacing vectors using impedance measurements. Summary Statistics Were Provided for LV Tip 1 to LV Ring 2 Measurements. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.|Pre-discharge (up to 7 days post implant)||||Ohms||Standard Deviation|Mean
2594470|NCT02232984|Secondary|Final Pacing Treshold at Pre-discharge|Characterize the electrical performance of BSC pacing vectors using pacing thresholds. Summary statistics for LV Tip1 to LV Ring 2 pacing thresholds for the BSC pacing vectors were reported. The electrical measurements were taken using the implanted pulse generator (PG) per standard practice.|Pre-discharge (up to 7 days post implant)||||Volts||Standard Deviation|Mean
2594471|NCT02232984|Primary|Number of Vectors With Phrenic Nerve Stimulation (PNS)|The primary objective of this study was to characterize the performance of Boston Scientific (BSC) unique pacing vectors vs. BSC/St Jude Medical (STJ) common pacing vectors to prevent phrenic nerve stimulation (PNS) based on the selected pacing cathode. BSC unique vectors are those that are only available with Boston Scientific's (BSC) quadripolar (X4) CRT-Ds while common vectors are those that are available for both BSC and STJ systems.|Pre-discharge (up to 7 days post implant)||||Number of Pacing vectors with PNS|||Number
2594472|NCT02232880|Secondary|Change in Inflammatory Markers|changes in plasma and T cell markers of activation and T cell cytokine production from randomization to end of 24 weeks of treatment|6 months|No patients received treatment prior to study termination||||||
2594473|NCT02232880|Secondary|Change in Brachial Artery Reactivity|change in brachial artery reactivity measured at randomization and after 24 weeks of treatment|6 months|No patients received treatment prior to study termination||||||
2594474|NCT02232880|Secondary|Change in Blood Pressure|Changes in the rate of change of blood pressure estimated by automated in office cuff measurements and ambulatory blood pressure at 12 weeks after randomization|6 months|No patients received treatment prior to study termination.||||||
2594475|NCT02232880|Primary|Change in Systolic Blood Pressure From Randomization to End of Treatment|Ambulatory blood pressure monitoring will be used at the end of the 4 weeks standardized treatment and at the end of 6 months randomized treatment with abatacept or placebo. The change in systolic blood pressure from these 2 recordings will be the primary endpoint.|6 months|No patients received treatment prior to study termination||||||
2594491|NCT02232425|Secondary|Proportion of Participants With ≥ 1 Category of Improvement in Satisfaction With Sexual Intercourse, on the Premature Ejaculation Profile (PEP) Questionnaire|Based on Premature Ejaculation Profile (PEP) 5 point scale with the scores ranging from 0 (worse answer) to 4 (best answer).|Baseline to 8 weeks|Intent to treat, excluding outliers|||adjusted proportion of participants||95% Confidence Interval|Number
2594492|NCT02232425|Secondary|Mean Change in Score on Ejaculation-related Personal Distress|Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.|Last 4 weeks of treatment compared to baseline|Intent to treat, excluding outliers|||units on a scale||95% Confidence Interval|Mean
2594476|NCT02232698|Secondary|Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 208|"The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).~There is one question to assess the change in perceived frequency of Hypoglycaemia and one question to assess change in perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less of the time now) to +3 (much more of the time now).~The ANCOVA adjusts for baseline DTSQs (status version)."|Baseline and Day 208||||units on a scale||Standard Deviation|Mean
2594477|NCT02232698|Secondary|System Utilisation|System utilisation assessed by percentage of sensor glucose data collected by the intervention group|Days 15 to 208|112 subjects included in the analysis, 7 were not included due to missing data.|||percentage of sensor glucose collected||Standard Deviation|Mean
2594478|NCT02232698|Secondary|Number of Glucose Measurements Performed|Number of blood glucose fingerstick tests per day by intervention and control group during baseline (days 1 to 15) and days 194 to 208. The number of sensor scans performed performed by the intervention group during days 15 to 208.|Days 1 to 208||||number of measurements per day||Standard Deviation|Mean
2594479|NCT02232698|Secondary|Time in Range|Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range).|Baseline and Days 194 to 208|1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.|||hours per day||Standard Deviation|Mean
2594480|NCT02232698|Secondary|Time Spent >180 mg/dL and >240 mg/dL|Difference in time >180 mg/dL and >240 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).|Baseline and Days 194 to 208|1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.|||hours per day||Standard Deviation|Mean
2594481|NCT02232698|Secondary|Frequency of Episodes <70 mg/dL, <55 mg/dL and <40 mg/dL|Difference in frequency of episodes <70 mg/dL, <55 mg/dL and <40 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).|Baseline and Days 194-208|1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.|||number of episodes per day||Standard Deviation|Mean
2594482|NCT02232698|Secondary|Time Spent <55 mg/dL and <40 mg/dL|Difference in time <55 mg/dL & <40 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).|Baseline and Days 194 to 208|1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.|||hours per day||Standard Deviation|Mean
2594483|NCT02232698|Secondary|HbA1c at 6 Months|Difference in HbA1c between intervention and control group at day 208 adjusting for baseline HbA1c at day 1|Baseline and Day 208||||percentage of Glycated Haemoglobin||Standard Deviation|Mean
2594484|NCT02232698|Primary|Time Spent <70 mg/dL|Difference in time <70 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15).|Baseline and Days 194 to 208|1 subject from the standard blood glucose monitoring group had no baseline sensor data and could not be included in the analysis of sensor data.|||hours per day||Standard Deviation|Mean
2594485|NCT02232425|Secondary|Incidence of Treatment-emergent Adverse Events|Number of participants with at least one treatment-emergent adverse event|Start of Treatment to end of study (approximately 10 weeks)|Intent to treat, excluding outliers|||participants|||Number
2594486|NCT02232425|Secondary|Change in Percentage of Intercourse Attempts Lasting Longer Than 1 Minute From Baseline to Last 4 Weeks on Treatment|"'Baseline' time period defined as Day -28 - Day 0. 'Last 4 Weeks' time period defined as the 28 days prior to last time subject took study drug and after Day 14.~Analysis excludes two subjects from ITT population: #010-012 (placebo) and #888-018 (active). Adjusted for treatment, baseline IELT, baseline percentage, country and site."|Baseline to last 4 weeks on treatment|Intent to treat, excluding outliers|||percentage of attempts||95% Confidence Interval|Mean
2594487|NCT02232425|Secondary|Proportion of Participants With ≥ 2 Category Increase in Control and ≥ 1 Category Decrease in Personal Distress on a Patient Reported Outcome (PRO) Measure|Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Each of the PEP questions is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer)|Baseline to 8 weeks|Intent to treat, excluding outliers|||proportion of participants|||Number
2594488|NCT02232425|Secondary|Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Interpersonal Difficulty on the Premature Ejaculation Profile (PEP) Questionnaire|Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.|Baseline to 8 weeks|Intent to treat, excluding outliers|||adjusted proportion of participants||95% Confidence Interval|Number
2594489|NCT02232425|Secondary|Proportion of Participants With ≥ 1 Category of Improvement in Ejaculation-related Distress on the Premature Ejaculation Profile ( PEP) Questionnaire|Reported in e-diary. Based on Premature Ejaculation Profile (PEP). Scale ranges from 'extremely' (0) to 'not at all' (4). An increase in score from baseline indicates improvement.|Baseline to 8 weeks|Intent to treat, excluding outliers|||adjusted proportion of participants||95% Confidence Interval|Number
2594490|NCT02232425|Secondary|Proportion of Participants With ≥ 1 Category of Improvement in Control Over Ejaculation During Sexual Intercourse on the Premature Ejaculation Profile (PEP) Questionnaire|Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP is scored on a 5 point scale with the scores ranging from 0 (worst answer) to 4 (best answer)|Baseline to 8 weeks|Intent to treat, excluding outliers|||adjusted proportion of participants||95% Confidence Interval|Number
2594539|NCT02231918|Secondary|Vital Signs (Pulse Rate)|Vital signs (Pulse rate (both supine and after standing for 1 minute)).|-0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h|Safety analysis set|||bpm||Standard Deviation|Mean
2594493|NCT02232425|Secondary|Mean Change in Score on Control of Timing of Ejaculation|Reported in electronic diary and based on the Premature Ejaculation Profile (PEP). PEP question on control of timing is scored on a 5 point scale with the scores ranging from very poor (this is the worst answer) scored as 0 to very good (this is the best answer scored as 4)|Last 4 weeks of treatment compared to baseline|Intent to treat, excluding outliers|||units on a scale||95% Confidence Interval|Mean
2594494|NCT02232425|Secondary|Mean Change in Arithmetic IELT (Intravaginal Ejaculatory Latency Time)|IX-01 versus placebo|Last 4 weeks of treatment compared to baseline|Intent to treat, excluding outliers|||seconds||95% Confidence Interval|Mean
2594495|NCT02232425|Secondary|Proportion of Participants With Greater Than or Equal to (≥) 2.5 Fold Increase in Intravaginal Ejaculatory Latency Time (IELT)|Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred. Outcome measured proportion of patients with at least a 2.5-fold increase in geometric mean IELT over the last 4 weeks of treatment as compared to baseline. Proportion of participants adjusted for baseline IELT, country and site|Last 4 weeks of treatment compared to baseline|Intent to treat, excluding outliers|||Proportion of participants||95% Confidence Interval|Number
2594496|NCT02232425|Secondary|Proportion of Participants Rating Their PE as Better or Much Better, on the Clinical Global Impression of Change (CGIC) Scale|7 point scale ranging from much worse (-3) to much better (3). The proportion refers to the proportion of patients who had the best 2 possible responses [better(2) or much better (3)] on this 7 point scale|Baseline to the end of treatment (approximately 8 weeks)|Intent to treat, excluding outliers|||proportion of participants|||Number
2594497|NCT02232425|Primary|Mean Fold Change in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)|IX-01 versus placebo. Intravaginal ejaculatory latency time (IELT) was defined as the time from the initiation of sexual intercourse (penetration) until ejaculation occurred|Last 4 weeks of treatment compared to baseline|Efficacy data set excluding outliers|||Seconds||95% Confidence Interval|Geometric Mean
2594498|NCT02232243|Primary|Optimal Biologic Dose of Hydroxychloroquine|Dose (mg twice daily) wherein 70% of patients exhibit a 2-fold increase in Par-4 levels with a dose-limiting toxicity of no more than 30%.|Day 14|All patients|||mg twice daily|||Number
2594499|NCT02232243|Primary|Patients With Elevated Par-4 Levels|Number of patients with 2-fold change in Par-4 levels from baseline to day 14|Baseline and day 14||||Participants|||Count of Participants
2594500|NCT02232178|Primary|T1/2z|Terminal half-life.|0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.|Per protocol PK population.|||hours||Standard Deviation|Mean
2594501|NCT02232178|Primary|Tmax|Time to maximum plasma concentration.|0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.||||hours||Standard Deviation|Mean
2594502|NCT02232178|Primary|AUC0-last|Area under the plasma concentration-time curve from Time 0 to time of last quantifiable plasma concentration.|0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.||||ng/mL∙hr||Standard Deviation|Mean
2594503|NCT02232178|Primary|Cmax|Maximum drug plasma concentration|0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.||||ng/mL||Standard Deviation|Mean
2594504|NCT02232126|Secondary|30-day Readmission Among Intervention Participants|The outcome measure is the rate of 30-day readmissions among Intervention group participants that declined to receive the in-home social work intervention versus those Intervention group participants that received the in-home social work intervention.|30-days|Analysis among Intervention group ONLY for this outcome|||30-day hospital readmissions|||Number
2594505|NCT02232126|Primary|30-day Hospital Readmission|The outcome measure is the number of readmissions experienced by participants in the Usual Care and Intervention groups within 30-days of their index discharge.|30-days post hospitalization||||30-day hospital readmissions|||Number
2594506|NCT02232074|Secondary|Self-efficacy for LUNG Cancer Patients at 12 Months|Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. A higher score indicates a positive attitude and strong self-efficacy. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.|12 months post-enrollment|The number of Lung Intervention participants decrease by 3 for a total of 5 and the number of Lung Control participants decreased by 6 for a total of 5 due to missing data at 12 months.|||score on a scale||Standard Deviation|Mean
2594507|NCT02232074|Secondary|Self-efficacy for BREAST Cancer Patients at 12 Months|Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. A higher score indicates a positive attitude and strong self-efficacy. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.|12 months post-enrollment|The number of BREAST Intervention participants decreased by 23 for a total of 81 and for control participants by 19 for a total of 74 due to missing values at 12 months post-enrollment.|||score on a scale||Standard Deviation|Mean
2594508|NCT02232074|Secondary|Patient Satisfaction With Navigation at 12 Months Among LUNG Cancer Patients|Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher scores are more favorable.|12 months post-enrollment|The number of Lung Intervention participants decrease by 5 for a total of 3 and the number of Lung Control participants decreased by 7 for a total of 4 due to missing data at 12 months.|||score on a scale||Standard Deviation|Mean
2594540|NCT02231918|Secondary|Vital Signs (Systolic and Diastolic Blood Pressure)|Vital signs (Systolic and diastolic blood pressure (both supine and after standing for 1 minute)).|-0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h post-dose.|Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.|||mmHg||Standard Deviation|Mean
2594509|NCT02232074|Secondary|Patient Satisfaction With Navigation at 12 Months Among BREAST Cancer Patients|Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher scores are more favorable.|12 months post-enrollment|The number of BREAST Intervention participants decreased by 52 for a total of 52 and Control participants decreased by 55 for a total of 38 due to missing data at 12 months post-enrollment.|||score on a scale||Standard Deviation|Mean
2594510|NCT02232074|Secondary|Cancer Needs and Distress Inventory at 12 Months for LUNG Cancer Patients|Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. The mean total score is reported.|12 months post-enrollment|The number of LUNG Intervention participants decreased by 3 for a total of 5. Control participants decreased by 6 for a total of 5 due to missing data at 12 months follow up.|||score on a scale||Standard Deviation|Mean
2594511|NCT02232074|Secondary|Cancer Needs and Distress Inventory at 12 Months for BREAST Cancer Patients|Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. The mean total score is reported.|12 months post-enrollment|The number of BREAST Intervention participants decreased by 23 for a total of 81. The Control participants decreased by 18 for a total of 75 due to missing CaNDI data at 12 months.|||score on a scale||Standard Deviation|Mean
2594512|NCT02232074|Secondary|Distress Thermometer at 12 Months for LUNG Cancer Patients|Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower scores are more favorable.|12 months after enrollment|The number of LUNG Intervention participants decreased by 3 for a total of 5. Control participants decreased by 6 for a total of 5 due to missing data at 12 months follow up.|||units on a scale||Standard Deviation|Mean
2594513|NCT02232074|Secondary|Distress Thermometer at 12 Months for BREAST Cancer Patients|Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable|12 months after enrollment|The number of BREAST Intervention participants decreased by 22 for a total of 82 and Control participants decreased by 18 for a total of 75 due to missing Distress Thermometer data at 12 months.|||units on a scale||Standard Deviation|Mean
2594514|NCT02232074|Secondary|Number of Participants Receiving Radiation Within 365 Days of Cancer Diagnosis|The receipt of quality care is defined as receiving radiation to the breast within one year of a breast cancer diagnosis if: under the age of 70, estrogen or progesterone tumor positive and had breast conserving surgery.|Measured at 12 months|Excluded those women who did not meet requirements for receipt of radiation: over 70 years of age, with tumor negative for estrogen or progesterone|||Participants|||Count of Participants
2594515|NCT02232074|Secondary|Self-efficacy for LUNG Cancer Patients at 6 Months|Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.|6 months post-enrollment|Within each cancer group (breast & lung cancers analyzed separately), a linear regression was used to test whether there was an association between the intervention & control groups in self-efficacy at six months post-enrollment, adjusting for baseline CASE Cancer score.|||total score on a scale||Standard Deviation|Mean
2594516|NCT02232074|Secondary|Self-efficacy for BREAST Cancer Patients at 6 Months|Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.|6 months post-enrollment|Within each cancer group (breast & lung cancers analyzed separately), a linear regression was used to test whether there was an association between the intervention & control groups in self-efficacy at six months post-enrollment, adjusting for baseline CASE Cancer score.|||total score on a scale||Standard Deviation|Mean
2594517|NCT02232074|Secondary|Patient Satisfaction With Navigation at 6 Months Among LUNG Cancer Patients|Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher values are more favorable.|6 months post-enrollment|Linear regression tested for an association between the intervention & control groups in satisfaction with patient navigation at six months post-enrollment. The number of LUNG Intervention participants decreased by 4 to 4 and the Control participants decreased by 8 to 3 due to missing Patient Satisfaction data at 6 month follow up|||units on a scale||Standard Deviation|Mean
2594518|NCT02232074|Secondary|Patient Satisfaction With Navigation at 6 Months Among BREAST Cancer Patients|Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher values are more favorable.|6 months post-enrollment|Linear regression tested for an association between the intervention & control groups in satisfaction with patient navigation at six months post-enrollment. The number of Breast Intervention participants decreased by 52 to 52 and the Control participants decreased by 41 to 52 due to missing Patient Satisfaction data at 6 month follow up|||units on a scale||Standard Deviation|Mean
2594519|NCT02232074|Secondary|Cancer Needs and Distress Inventory at 6 Months for LUNG Cancer Patients|Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. For this analysis, the mean total score is reported with the minimum value=1 and the maximum value=2.3. Lower values are more favorable.|6 months post-enrollment|The number of Lung Intervention participants decreased by 2 to 6 and the Control participants decreased by 4 to 7 due to missing CaNDi data at 6 month follow up|||score on a scale||Standard Deviation|Mean
2594520|NCT02232074|Secondary|Cancer Needs and Distress Inventory at 6 Months for BREAST Cancer Patients|Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. For this analysis, the mean total score is reported with the minimum value=1 and the maximum value=4.10. Lower values are more favorable.|6 months post-enrollment|The number of Breast Intervention participants decreased by 13 to 91 and the Control participants decreased by 8 to 85 due to missing CaNDi data at 6 month follow up|||score on a scale||Standard Deviation|Mean
2594521|NCT02232074|Secondary|Distress Thermometer at 6 Months for LUNG Cancer Patients|Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress).Lower values are more favorable.|6 months after enrollment|The number of LUNG Intervention participants decreased by 2 for a total of 6 and Control patients decreased by 4 due to missing Distress Thermometer data at 6 months.|||units on a scale||Standard Deviation|Mean
2594522|NCT02232074|Secondary|Distress Thermometer at 6 Months for BREAST Cancer Patients|Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable.|6 months after enrollment|The number of BREAST Intervention participants decreased by 13 for a total of 91 and Control participants decreased by 8 for a total of 58 due to missing Distress Thermometer data at 6 months.|||units on a scale||Standard Deviation|Mean
2594523|NCT02232074|Secondary|Distress Thermometer at 3 Months for LUNG Cancer Patients|Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable.|3 months after enrollment|The number of LUNG Control participants decreased by 3 for a total of 8 due to missing Distress Thermometer data at 3 months.|||units on a scale||Standard Deviation|Mean
2594524|NCT02232074|Secondary|Distress Thermometer at 3 Months for BREAST Cancer Patients|Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable.|3 months after enrollment|The number of Intervention participants decreased by 5 to 99 and Control participants decreased by 3 to 90 due to missing Distress Thermometer data at 3 months.|||units on a scale||Standard Deviation|Mean
2594525|NCT02232074|Primary|Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among LUNG Cancer Participants|The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality The time element was calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable depends on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation.|Receipt of 1st treatment within 90 days from diagnosis||||Participants|||Count of Participants
2594526|NCT02232074|Primary|Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants|The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality The time element was calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable depends on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation.|Receipt of 1st treatment within 90 days from diagnosis|breast cancer participants with 1 or more legal concern as screened at baseline using the IHELP survey.|||Participants|||Count of Participants
2594527|NCT02232022|Secondary|Number of Patients That Had Multiple AF Episodes|Number of patients that had multiple AF episodes.|1 year||||Participants|||Count of Participants
2594528|NCT02232022|Secondary|Incidence of Recurrent Stroke|Incidence of recurrent ischemic stroke.|1 year||||Participants|||Count of Participants
2594529|NCT02232022|Secondary|Percentage of Asymptomatic AF|Percentage of asymptomatic AF episodes.|1 year||||Participants|||Count of Participants
2594530|NCT02232022|Secondary|Duration of AF Episodes.|Duration of AF episodes (mean and range).|1 year||||min||Full Range|Mean
2594531|NCT02232022|Secondary|Patients Who Are Diagnosed With AF Who Are Changed to Anticoagulant Therapy.|Percentage of patients who are diagnosed with AF who are changed to anticoagulant therapy.|1 year||||Participants|||Count of Participants
2594532|NCT02232022|Primary|Incidence of Paroxysmal Atrial Fibrillation (AF) in Ischemic Stroke Patients|The incidence of paroxysmal atrial fibrillation (AF) in ischemic stroke patients who have a presumed known stroke etiology other than atrial fibrillation.|1 year||||Participants|||Count of Participants
2594533|NCT02232009|Secondary|Subject Change in Temperature|Change in temperature (Celsius) per subject.|1 Day||||Degrees Celsius||Standard Deviation|Mean
2594534|NCT02232009|Secondary|Overall Image Quality|Scores range from 1-Very Poor image quality to 5-Excellent image quality.|1 day||||Frequency of ratings|||Number
2594535|NCT02232009|Secondary|Overall Experience With Neonatal MR Scanner Device Summary|User survey results on a scale from 1 to 5, where 1 = strongly disagree and 5 = strongly agree.|1 day||||score on a scale||Full Range|Mean
2594536|NCT02232009|Secondary|MRI Scan Time|Duration of MRI scan time for each subject|1 Day||||minutes||Standard Deviation|Mean
2594537|NCT02232009|Primary|Image Diagnostic Quality|Number of subject whose images were rated as Evaluable|1 Day||||Participants|||Count of Participants
2594538|NCT02232009|Primary|Summary Rates of Adverse Events|Safety will be assessed based on the number of Adverse Events.|1 Day||||number of occurrences|||Number
2607309|NCT02091752|Secondary|Change From Baseline in Spleen Length and Spleen Volume||Baseline, Week 24|The study was terminated early due to low enrollment. Analysis was not done.||||||
2594541|NCT02231918|Secondary|Number of Patients With Drug Related Adverse Events|Number of patients with adverse events due to study drug.|From first drug administration until 24 hours after last study drug administration, upto 48 days|Safety analysis set: The safety population comprised all patients who provided informed consent and received at least one dose of study drug.|||participants|||Number
2594542|NCT02231918|Primary|PTF|Peak-trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state.|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||% of PTF||Geometric Coefficient of Variation|Geometric Mean
2594543|NCT02231918|Primary|CLR,ss|Renal clearance of the analyte at steady state (CLR(0-12),ss ).|12h after last study drug administration on day 1|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2594544|NCT02231918|Primary|fe 0-12,ss|Fraction of administered drug excreted unchanged in urine at steady state over a time interval t1 to t2 (fe 0-12,ss ).|12 hours after last study drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||% of PPX excreted||Geometric Coefficient of Variation|Geometric Mean
2594545|NCT02231918|Primary|Ae 0-12,ss|Amount of analyte that is eliminated in urine at steady state over a time interval t1to t2 (0-12h).|12 hours after last study drug administration on day 1|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||ng||Geometric Coefficient of Variation|Geometric Mean
2594546|NCT02231918|Primary|Vz/F,ss|Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||L||Geometric Coefficient of Variation|Geometric Mean
2594547|NCT02231918|Primary|CL/F,ss|Apparent clearance of the analyte in the plasma after extravascular administration at steady state; F = absolute bioavailability factor (CL/F,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2594548|NCT02231918|Primary|MRTpo,ss|Mean residence time of the analyte in the body at steady state (MRTpo,ss).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||h||Geometric Coefficient of Variation|Geometric Mean
2594549|NCT02231918|Primary|t1/2,ss|Terminal half-life of the analyte in plasma at steady state (t1/2,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||hours||Geometric Coefficient of Variation|Geometric Mean
2594550|NCT02231918|Primary|λz,ss|Terminal rate constant in plasma at steady state (λz,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2594551|NCT02231918|Primary|AUCτ,ss|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss ).|0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on Day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2594552|NCT02231918|Primary|Tmin,ss|Time from dosing to minimum concentration at steady state (Tmin,ss ).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable subjects who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||hours||Full Range|Median
2594553|NCT02231918|Primary|Tmax,ss|Time from dosing to maximum concentration at steady state (Tmax,ss).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||hours||Full Range|Median
2594554|NCT02231918|Primary|Cavg|Average concentration of the analyte in plasma at steady state (Cavg).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2594555|NCT02231918|Primary|Cpre,N|Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2594556|NCT02231918|Primary|Cmin,ss|Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||ng/mL||Standard Deviation|Geometric Mean
2594557|NCT02231918|Primary|Cmax,ss|Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss).|0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.|Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2594558|NCT02231892|Primary|Imaging Outcome Measures|"These measures include resting state (seed-based functional connectivity), Arterial Spin labeling (ASL), and MRI Spectroscopy (MRS).~Seed based - correlation coefficient changes~ASL - % change~MRS - % change"|Twice per session in MRI Phase (pre-TMS and immediately post-TMS)|Data have not yet been analyzed due to personnel turnover. There are currently no resources to complete data analysis at this time. We have transferred data to a repository protocol for future analysis when resources for data analysis are available.||||||
2594559|NCT02231892|Primary|Behavioral Outcome Measure|"Behavioral effects of INTENSITY (Sham/100%MT/110%MT) and demand for cognitive control, DEMAND (High/Medium/Low), were planned to be quantified via correct response time (RT) and trial accuracy using R Project for Statistical Computing (package afex, function mixed (Singmannet al, 2015)). RT data were planned to be submitted to a linear mixed model with a random intercept per subject and fixed effects of INTENSITY and DEMAND. Accuracy data were planned to be submitted to a generalized linear mixed model with a binomial distribution and logit link function with a random intercept per subject and fixed effects of INTENSITY and DEMAND.~During the Behavioral phase of the study, this data was collected before TMS, immediately after TMS, and 1 hour after TMS. During the MRI phase of the study, this data was only collected before TMS and immediately after TMS."|3x per session in Behavioral phase (before TMS, immediately after TMS, and 1 hour after TMS), and 2x per session in MRI Phase (before TMS and immediately after TMS).|Data have not yet been analyzed due to personnel turnover. There are currently no resources to complete data analysis at this time. We have transferred data to a repository protocol for future analysis when resources for data analysis are available.||||||
2594560|NCT02231762|Secondary|Pharmacokinetic (PK) Results: Lanreotide ATG 120 mg Serum Concentrations Within 12 Months|"Lanreotide ATG levels were measured in a subset of subjects to evaluate if temozolomide co-treatment had an impact on lanreotide serum concentration over a 12 month period.~Blood samples were collected for the determination of lanreotide ATG in serum at baseline, weeks 4, 12, 24 and 48 (end of study).~The concentrations of lanreotide ATG in serum were determined by a validated radioimmunoassay analysis method with a lower limit of quantitation of 0.08 nanograms [ng]/mL).~Serum concentrations of lanreotide ATG at each of the time points in the combination and maintenance phase are presented. Only subjects with data available for analysis are presented."|Baseline (week 1) and weeks 4, 12, 24 and 48|PK analysis was performed using the valid PK population.|||ng/mL||Standard Deviation|Mean
2594561|NCT02231762|Secondary|DCR by O6-methylguanine-DNA Methyl-transferase (MGMT) Expression and Methylation and Somatostatin Receptor (SSTR) Expression After 6 Months|"In all subjects whose tumour tissue was available, MGMT expression/methylation and SSTR expression was analysed. After 6 months, the DCR (SD+PR+CR) by MGMT methylation and expression and by SSTR 2a and SSTR 5 expression was evaluated.~DCR in response to MGMT methylation and expression results are presented. SSTR 2a and SSTR 5 expression is categorised as: No Receptors, Cytoplasmatic Expression (CE), Focal Expression (FE), Complete Circumferent Membrane Expression (CCME).~The DCR was defined as the proportion of subjects with a response of CR, PR or SD after 6 months of combination treatment within each methylation/expression category. The DCR was described in the ITT population along with its 95% CI and was compared to 45% with an exact binomial proportion test."|6 months|Percentages are based on the number of subjects in the ITT population and with data available for analysis.|||percentage of subjects||95% Confidence Interval|Number
2594562|NCT02231762|Secondary|QoL Questionnaire QLQ-GI.NET21: Mean Change From Baseline at 12 Months|Subjects were instructed to complete the QLQ-GI.NET21 questionnaire at baseline, weeks 12, 24, 36, 48 (end of study) or at early withdrawal. It contained 21 questions that used a 4-point scale (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much) to evaluate 3 defined multi-item symptom scales (endocrine, gastrointestinal and treatment related side effects), 2 single item symptoms (bone/muscle pain and concern about weight loss), 2 psychosocial scales (social function and disease-related worries) and 2 other single items (sexuality and communication). Answers were converted into grading scale, with values between 0 and 100. Each individual subscore was transformed to range from 0 to 100. The mean change from baseline at week 48 (end of study) is presented with a higher score representing a higher level response. Thus, a better level of functioning/a worse level of symptoms.|12 months|Only subjects in the ITT Population with data available at the week 48 time point were analysed. Only subjects with data available for analysis are presented.|||units on a scale||Standard Deviation|Mean
2594563|NCT02231762|Secondary|Quality of Life Gastrointestinal Neuroendocrine Tumour 21 Questionnaire (QLQ-GI.NET21): Mean Change From Baseline at 6 Months|Subjects were instructed to complete the QLQ-GI.NET21 questionnaire at baseline, weeks 12, 24 or at early withdrawal. It contained 21 questions that used a 4-point scale (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much) to evaluate 3 defined multi-item symptom scales (endocrine, gastrointestinal and treatment related side effects), 2 single item symptoms (bone/muscle pain and concern about weight loss), 2 psychosocial scales (social function and disease-related worries) and 2 other single items (sexuality and communication). Each individual subscore was transformed to range from 0 to 100. The mean change from baseline at week 24 (end of combination phase) is presented with a higher score representing a higher level response. Thus, a better level of functioning/a worse level of symptoms.|6 months|Only subjects in the ITT Population with data available at the week 24 time point were analysed. Only subjects with data available for analysis are presented.|||Units on a scale||Standard Deviation|Mean
2594572|NCT02231762|Secondary|Duration of Response (DoR) Within 12 Months|"The DoR is an estimation of the time from first documented objective response (CR or PR) to the first date of progressive disease (PD) or death due to disease progression for subjects who experienced an objective response within the first 12 months of treatment (combination and maintenance phases).~The Kaplan-Meier method was used to estimate the median DoR and its 95% CI for subjects in the ITT population who had an objective response."|12 months|The ITT population is all treated subjects having at least one baseline and at least one post baseline assessment of the primary efficacy parameter.|||months||95% Confidence Interval|Median
2608785|NCT02074059|Secondary|PCO2|Arterial carbon dioxide|Within 3 Hours of Randomization|Safety Population|||percentage of arterial carbon dioxide||Standard Deviation|Mean
2594564|NCT02231762|Secondary|EORTC QoL Questionnaire QLQ-C30: Mean Change From Baseline at 12 Months|Subjects were instructed to complete QLQ-C30 questionnaire at baseline, weeks 12, 24, 36, 48 (end of study) or at early withdrawal. The first 28 questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea/vomiting, pain) & 6 other single items. The last 2 questions represented subject's assessment of overall health & quality of life, coded on a 7-point scale (1=very poor to 7=excellent). The mean change from baseline at week 48 (end of study) is presented for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Each individual subscore was transformed to range from 0 to 100. A higher score represents a higher level response. Thus, a better QoL/a better level of functioning/a worse level of symptoms.|12 months|Only subjects in the ITT Population with data available at the week 48 time point were analysed. Only subjects with data available for analysis are presented.|||units on a scale||Standard Deviation|Mean
2594565|NCT02231762|Secondary|European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Core 30 Questionnaire (QLQ-C30): Mean Change From Baseline at 6 Months|Subjects were instructed to complete the QLQ-C30 questionnaire at baseline, weeks 12, 24 or at early withdrawal. The first 28 questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea/vomiting, pain) & 6 other single items. The last 2 questions represented subject's assessment of overall health & quality of life, coded on a 7-point scale (1=very poor to 7=excellent). The mean change from baseline at week 24 (end of the combination phase) is presented for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Each individual subscore was transformed to range from 0 to 100. A higher score represents a higher level response. Thus, a better QoL/a better level of functioning/a worse level of symptoms.|6 months|Only subjects in the ITT Population with data available at the week 24 time point were analysed. Only subjects with data available for analysis are presented.|||units on a scale||Standard Deviation|Mean
2594566|NCT02231762|Secondary|The Number of Subjects With a Symptomatic Response After 12 Months - Maintenance Phase|"Symptomatic response was evaluated as absolute change from baseline in the number of episodes of the lead symptoms (i.e. diarrhoea and flushing) using the mean of the last 3 days before the visit, at each visit, as compared to baseline.~Symptomatic responses were categorised as: Reduction, Increase or Stability of occurrences of diarrhoea / Reduction, Increase or Stability of occurrences of flushing.~The number of subjects in each response category at week 48 (end of study) is presented. Analysis was only carried out on subjects in the ITT population with functioning NET."|12 months|Subjects in the ITT population with functioning NET.|||Participants|||Count of Participants
2594567|NCT02231762|Secondary|The Number of Subjects With a Symptomatic Response After 6 Months|"Symptomatic response was evaluated as absolute change from baseline in the number of episodes of the lead symptoms (i.e. diarrhoea and flushing) using the mean of the last 3 days before the visit, at each visit, as compared to baseline.~Symptomatic responses were categorised as: Reduction, Increase or Stability of occurrences of diarrhoea / Reduction, Increase or Stability of occurrences of flushing.~The number of subjects in each response category at week 24 (end of the combination phase) is presented. Analysis was only carried out on subjects in the ITT population with functioning NET."|6 months|Subjects in the ITT population with functioning NET.|||Participants|||Count of Participants
2594568|NCT02231762|Secondary|The Number of Subjects With a Biochemical Response Using 5-HIAA Levels After 12 Months|"Urine samples for 5-HIAA urinary tumour marker analysis were taken at baseline, weeks 12, 24, 36, 48 (end of study) and early withdrawal.~Biochemical response based on 5-HIAA levels was categorised as: Response (5-HIAA reduction compared to baseline) or Progression (5-HIAA increase compared to baseline).~The number of subjects in each response category at each time point in the maintenance phase is presented. Analysis was only carried out on subjects in the ITT population with functioning NET."|12 months|Subjects in the ITT population with functioning NET.|||Participants|||Count of Participants
2594569|NCT02231762|Secondary|The Number of Subjects With a Biochemical Response Using 5-Hydroxy-Indol-Amino-Acid (HIAA) Levels After 6 Months|"Urine samples for 5-HIAA urinary tumour marker analysis were taken at at baseline, weeks 12, 24and early withdrawal.~Biochemical response based on 5-HIAA levels was categorised as: Response (5-HIAA reduction compared to baseline) or Progression (5-HIAA increase compared to baseline).~The number of subjects in each response category at each time point in the combination phase is presented. Analysis was only carried out on subjects in the ITT population with functioning NET."|6 months|Subjects in the ITT population with functioning NET.|||Participants|||Count of Participants
2594570|NCT02231762|Secondary|The Number of Subjects With a Biochemical Response Using CgA Levels After 12 Months|"Blood samples for CgA blood tumour marker analysis were taken at baseline, weeks 12, 24, 36, 48 (end of study) and at early withdrawal. The biochemical response after 12 months combination and maintenance treatment was estimated for subjects with abnormal CgA levels at baseline. Abnormal CgA levels were defined as above the upper limit of normal range (≥100 mcg/L).~Biochemical response based on CgA levels was categorised as: PR (decrease of CgA ≥50 % compared to the baseline CgA), SD (decrease < 50% or an increase ≤ 25% compared to the baseline CgA) or PD (defined as an increase ≥ 25%, compared to the baseline CgA).~The number of subjects in each response category at each time point in the maintenance phase is presented. Analysis was only carried out on subjects in the ITT population who had abnormal CgA at baseline."|12 months|Subjects in the ITT population with abnormal CgA levels at baseline.|||Participants|||Count of Participants
2594571|NCT02231762|Secondary|The Number of Subjects With a Biochemical Response Using Chromogranin-A (CgA) Levels After 6 Months|"Blood samples for CgA blood tumour marker analysis were taken at baseline, weeks 12, 24 and at early withdrawal. The biochemical response after 6 months combination treatment was estimated for subjects with abnormal CgA levels at baseline. Abnormal CgA levels were defined as above the upper limit of normal range (≥100 micrograms/litre [mcg/L]).~Biochemical response based on CgA levels was categorised as: PR (decrease of CgA ≥ 50%, compared to the baseline CgA), SD (decrease < 50 % or an increase ≤25%, compared to the baseline CgA) or PD (defined as an increase ≥25 %, compared to the baseline CgA).~The number of subjects in each response category at each time point in the combination phase is presented. Analysis was only carried out on subjects in the ITT population who had abnormal CgA at baseline."|6 months|Subjects in the ITT population with abnormal CgA levels at baseline.|||Participants|||Count of Participants
2594573|NCT02231762|Secondary|Time To Response (TtR) Within 12 Months|"TtR was defined as the time from the date of treatment start to the date of the first documented objective response (CR or PR) within the first 12 months of treatment (combination and maintenance phases). A Kaplan Meier estimate of the TtR survival function was constructed.~The Kaplan-Meier method was used to estimate the median TtR and its 95% CI for subjects in the ITT population (50% of subjects were expected to have a CR or PR at this time)."|12 months|The ITT population is all treated subjects having at least one baseline and at least one post baseline assessment of the primary efficacy parameter|||months||95% Confidence Interval|Median
2594574|NCT02231762|Secondary|Progression-Free Survival (PFS) Within 12 Months|"PFS was defined as the time from the date of treatment start to the date of the first documented disease progression or death due to any cause within the first 12 months of treatment. If a subject had not progressed or died after 12 months of treatment or when any further anti-neoplastic therapy was received, PFS was censored at the time of the last tumour assessment before the analysis cut-off date or the anti-neoplastic therapy date.~A Kaplan-Meier estimate of the PFS was calculated to determine the number of subjects at risk. Median PFS time (50% of subjects who would not progress or die) of the ITT population is presented along with 95 % CI."|12 months|The ITT population is all treated subjects that had at least one baseline and at least one post baseline assessment of the primary efficacy parameter.|||months||95% Confidence Interval|Median
2594575|NCT02231762|Secondary|DCR After 12 Months|"All tumour assessments were performed using the RECIST criteria (1.1). CT-scan or MRI could be used for as method of tumour measurement and the same method of tumour measurement was used throughout the study for each subject. CT scans/MRI were performed at screening or baseline visit then at baseline, weeks 12, 24, 36, 48 (end of study) and at study withdrawal or at anytime during the study in the case of any clinical or biological signs of tumour progression.~The DCR was defined as the proportion of subjects with a response of CR, PR or SD after 6 months combination treatment followed by either 6 months of lanreotide ATG 120 mg maintenance treatment or no treatment. The DCR was described in the ITT population along with its 95% CI and was compared to 45% with an exact binomial proportion test. The LOCF method was used to replace missing assessments at the end of the maintenance phase."|12 months|The ITT population is all subjects that had at least one baseline and at least one post baseline assessment of the primary efficacy parameter.|||percentage of subjects||95% Confidence Interval|Number
2594576|NCT02231762|Primary|Disease Control Rate (DCR) After 6 Months|"All tumour assessments were performed using the Response Evaluation Criteria In Solid Tumours (RECIST) criteria (1.1). Computer Tomography (CT-scan) or Magnetic Resonance Imaging (MRI) could be used for as method of tumour measurement and the same method of tumour measurement was used throughout the study for each subject. CT scans/MRI were performed at screening or baseline visit then at weeks 12, 24 and at early withdrawal or at anytime during the study in the case of any clinical or biological signs of tumour progression.~The DCR was defined as the proportion of subjects with a response of CR, PR or SD after 6 months of combination treatment and was described in the ITT population along with its 95% Confidence Interval (CI) and was compared to 45% with an exact binomial proportion test. The Last Observation Carried Forward (LOCF) method was used to replace missing assessments at the end of the combination phase."|6 months|The ITT population is all subjects that had at least one baseline and at least one post baseline assessment of the primary efficacy parameter.|||percentage of subjects||95% Confidence Interval|Number
2594577|NCT02231749|Secondary|Progression-Free Survival (PFS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)|PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.|From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months)|All Randomized|||months||95% Confidence Interval|Median
2594578|NCT02231749|Secondary|Overall Survival (OS) in Any Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)|"Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time will be censored at the date of last contact (last known alive date). Overall survival will be censored for subjects at the date of randomization if they were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after subject's off-treatment date."|From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)|All Randomized|||months||95% Confidence Interval|Median
2594579|NCT02231749|Secondary|Investigator-assessed Objective Response Rate(ORR) in Any Risk Participants Per IRRC Using RECIST v1.1|ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on IRRC assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)|All Randomized|||percentage of participants||95% Confidence Interval|Number
2594580|NCT02231749|Primary|Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)|PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the IRRC (as per RECIST 1.1 criteria), or death due to any cause, whichever occurred first. Subsequent therapy included anticancer therapy, tumor directed radiotherapy, or tumor directed surgery. Subjects who died without a reported progression were considered to have progressed on the date of their death.|From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to June 2017, approximately 31 months)|All Intermediate/Poor-Risk Participants|||months||95% Confidence Interval|Median
2594610|NCT02231177|Secondary|FEV1 Change From Baseline|"Mean change from baseline in forced expiratory volume in one second (FEV1). Pulmonary function test.~The baseline value was measured pre-dose on day 1 of the first treatment period."|0:30 and 1:00 h after drug administration on the first day of each treatment period|Treated Set.|||L||Standard Deviation|Mean
2594581|NCT02231749|Primary|Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC)|"OS was defined as the time from randomization to the date of death from any cause. Survival time was censored at the date of last contact (last known alive date) for subjects who were alive."|From the date of randomization to the date of death (assessed up to June 2017, approximately 31 months)|All Intermediate/Poor-Risk Participants|||months||95% Confidence Interval|Median
2594582|NCT02231749|Primary|Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants Per IRRC Using RECIST v1.1|ORR was defined as the proportion of randomized subjects who achieved a best response of complete response (CR) or partial response (PR) using the RECIST v1.1 criteria based on IRRC assessment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), greater than or equal to 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to June 2017, approximately 31 months)|All Intermediate/Poor-Risk Participants|||percentage of participants||95% Confidence Interval|Number
2594583|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Tapping Frequency as Assessed by Pedomotography|Pedomotography was used to assess the tap duration and variability in a foot speeded tapping task. The patient placed their foot on the foot device such that the ball of the foot was positioned above a force transducer, and recordings were started after practice runs. The patient was then instructed to foot tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each foot. The tapping frequency was calculated as the number of taps between the onsets of the first and the last tap divided by the time in between. The mean changes from Baseline to Day 28 in the tapping frequency for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||Hertz||Standard Deviation|Mean
2594584|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Variability of Peak TF as Assessed by Pedomotography|Pedomotography was used to assess the tap duration and variability in a foot speeded tapping task. The patient placed their foot on the foot device such that the ball of the foot was positioned above a force transducer, and recordings were started after practice runs. The patient was then instructed to foot tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each foot. The mean changes from Baseline to Day 28 in the variability of TF for the left and right feet are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||percentage of variation||Standard Deviation|Mean
2594585|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of ITI as Assessed by Pedomotography|Pedomotography was used to assess the tap duration and variability in a foot speeded tapping task. The patient placed their foot on the foot device such that the ball of the foot was positioned above a force transducer, and recordings were started after practice runs. The patient was then instructed to foot tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each foot. The mean changes from Baseline to Day 28 in the duration and variability of ITI for the left and right feet are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
2594586|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of IPI as Assessed by Pedomotography|Pedomotography was used to assess the tap duration and variability in a foot speeded tapping task. The patient placed their foot on the foot device such that the ball of the foot was positioned above a force transducer, and recordings were started after practice runs. The patient was then instructed to foot tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each foot. The mean changes from Baseline to Day 28 in the duration and variability of IPI for the left and right feet are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
2594611|NCT02231177|Secondary|FVC Change From Baseline|"Mean change from baseline in forced vital capacity (FVC). Pulmonary function test.~The baseline value was measured pre-dose on day 1 of the first treatment period."|0:30 and 1:00 h after drug administration on the first day of each treatment period|Treated Set.|||L||Standard Deviation|Mean
2594612|NCT02231177|Secondary|Concentration of Tiotropium in Plasma|"Concentration of the analyte in plasma at 0.333 hours (20 minutes) after the 8th, 14th and 21st dose, C(0.333_8), C(0.333_14,ss) and C(0.333_21,ss) respectively. As steady state was anticipated to be reached by day 14 at the latest, the index 'ss' was used for days 14 and 21.~The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2594587|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of TD as Assessed by Pedomotography|Pedomotography was used to assess the tap duration and variability in a foot speeded tapping task. The patient placed their foot on the foot device such that the ball of the foot was positioned above a force transducer, and recordings were started after practice runs. The patient was then instructed to foot tap as fast as possible between 2 auditory cues. The patient was then instructed to foot tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each foot. The mean changes from Baseline to Day 28 in the duration and variability of TD for the left and right feet are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
2594588|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of IOI as Assessed by Pedomotography|Pedomotography was used to assess the tap duration and variability in a foot speeded tapping task. The patient placed their foot on the foot device such that the ball of the foot was positioned above a force transducer, and recordings were started after practice runs. The patient was then instructed to foot tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each foot. The mean changes from Baseline to Day 28 in the duration and variability of IOI for the left and right feet are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
2594589|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Tapping Frequency as Assessed by Dysdiadochomotography|Dysdiadochomotography was used to assess the regularity of hand taps performed when alternating between the palm and dorsal surface of the hand performing a repetitive pronation/supination movement. The force and duration of the hand taps were recorded, with their hand positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to hand tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The tapping frequency was calculated as the number of taps between the onsets of the first and the last tap divided by the time in between. The mean changes from Baseline to Day 28 in the tapping frequency for the left and right hands are presented as raw data. GLS mean ratios are in original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||Hertz||Standard Deviation|Mean
2594590|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Variability of Peak TF as Assessed by Dysdiadochomotography|Dysdiadochomotography was used to assess the regularity of hand taps performed when alternating between the palm and dorsal surface of the hand performing a repetitive pronation/supination movement. The force and duration of the hand taps were recorded, with their hand positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to hand tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the variability of TF for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||percentage of variation||Standard Deviation|Mean
2594591|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of ITI as Assessed by Dysdiadochomotography|Dysdiadochomotography was used to assess the regularity of hand taps performed when alternating between the palm and dorsal surface of the hand performing a repetitive pronation/supination movement. The force and duration of the hand taps were recorded, with their hand positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to hand tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the duration and variability of ITI for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
2594613|NCT02231177|Secondary|Concentration of Olodaterol in Plasma|"Concentration of the analyte in plasma at 0.333 hours (20 minutes) after the 8th, 14th and 21st dose, C(0.333_8), C(0.333_14,ss) and C(0.333_21,ss) respectively. As steady state was anticipated to be reached by day 14 at the latest, the index 'ss' was used for days 14 and 21.~The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2595265|NCT02224599|Primary|Adverse Events Due to Administration of TAPA-Pulse DC Vaccine|Grade, causality, start/stop dates (duration), resolutions for adverse events will be monitored and recorded.|Continuous for 45 days after the first dose.|Enrollment was terminated||||||
2594592|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of IPI as Assessed by Dysdiadochomotography|Dysdiadochomotography was used to assess the regularity of hand taps performed when alternating between the palm and dorsal surface of the hand performing a repetitive pronation/supination movement. The force and duration of the hand taps were recorded, with their hand positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to hand tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the duration and variability of IPI for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
2594593|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of TD as Assessed by Dysdiadochomotography|Dysdiadochomotography was used to assess the regularity of hand taps performed when alternating between the palm and dorsal surface of the hand performing a repetitive pronation/supination movement. The force and duration of the hand taps were recorded, with their hand positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to hand tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the duration and variability of TD for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
2594594|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of IOI as Assessed by Dysdiadochomotography|Dysdiadochomotography was used to assess the regularity of hand taps performed when alternating between the palm and dorsal surface of the hand performing a repetitive pronation/supination movement. The force and duration of the hand taps were recorded, with their hand positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to hand tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the duration and variability of IOI for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
2594595|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Tapping Frequency (Freq) as Assessed by Digitomotography|Digitomotography was used to assess the duration and the variability of TD in an index finger speeded tapping task. The patient placed their hand on a hand rest with their index finger positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to finger tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The tapping frequency was calculated as the number of taps between the onsets of the first and the last tap divided by the time in between. The mean changes from Baseline to Day 28 in the tapping frequency for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||Hertz||Standard Deviation|Mean
2594596|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Variability of Peak Tapping Forces (TF) as Assessed by Digitomotography|Digitomotography was used to assess the duration and the variability of TD in an index finger speeded tapping task. The patient placed their hand on a hand rest with their index finger positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to finger tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the variability of TF for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||percentage of variation||Standard Deviation|Mean
2594614|NCT02231177|Secondary|Tmin,ss of Tiotropium|Time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (tmin,ss)|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||h||Full Range|Median
2594615|NCT02231177|Secondary|Tmin,ss of Olodaterol|Time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (tmin,ss)|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||h||Full Range|Median
2594597|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of Inter Tap Intervals (ITI) as Assessed by Digitomotography|Digitomotography was used to assess the duration and the variability of ITI in an index finger speeded tapping task. The patient placed their hand on a hand rest with their index finger positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to finger tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the duration and variability of ITI for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
2594598|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of Inter Peak Intervals (IPI) as Assessed by Digitomotography|Digitomotography was used to assess the duration and the variability of tap IPI in an index finger speeded tapping task. The patient placed their hand on a hand rest with their index finger positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to finger tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the duration and variability of IPI for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
2594599|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of Tap Durations (TD) as Assessed by Digitomotography|Digitomotography was used to assess the duration and the variability of TD in an index finger speeded tapping task. The patient placed their hand on a hand rest with their index finger positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to finger tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the duration and variability of TD for the left and right hands are presented a raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
2594600|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Duration and Variability of Inter Onset Intervals (IOI) as Assessed by Digitomotography|Digitomotography was used to assess the duration and the variability of tap IOI in an index finger speeded tapping task. The patient placed their hand on a hand rest with their index finger positioned on a force transducer, and recordings were started after practice runs. The patient was then instructed to finger tap as fast as possible between 2 auditory cues. The beginning of a tap was defined as a rise of the force by 0.05 N above maximal baseline level. The tap ended when it dropped to 0.05 N before the maximal baseline level was reached again. 5 trials of 10 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the duration and variability of IOI for the left and right hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day-1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||seconds||Standard Deviation|Mean
2594601|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Isometric Grip Forces as Determined by Manumotography|The coordination of isometric grip forces in the precision grip between the thumb and index finger were assessed by Manumotography. Grip forces were assessed during grip initiation, object transport and in a static holding phase. Subjects were instructed to grasp and lift a device equipped with a force transducer and 3D position sensor in the precision grip between thumb and index finger and hold it stable adjacent to a marker 10 centimetres high. Grip forces and 3D position and orientation of the object were recorded. Mean isometric grip forces and grip force variability in the static phase (expressed as coefficient of variation = standard deviation/mean x 100 [GFV-C]) were calculated during a 15 second period. 5 trials of 20 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the mean isometric grip forces of each hand are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||Newton||Standard Deviation|Mean
2594616|NCT02231177|Secondary|Cmin,ss of Tiotropium|"Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).~The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2594617|NCT02231177|Secondary|Cmin,ss of Olodaterol|"Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).~The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2594602|NCT02231580|Secondary|Change From Baseline to Day 28 in the Mean Grip Force Variability as Determined by Manumotography|The coordination of isometric grip forces in the precision grip between the thumb and index finger were assessed by Manumotography. Grip forces were assessed during grip initiation, object transport and in a static holding phase. Subjects were instructed to grasp and lift a device equipped with a force transducer and 3D position sensor in the precision grip between thumb and index finger and hold it stable adjacent to a marker 10 centimetres high. Grip forces and 3D position and orientation of the object were recorded. Mean isometric grip forces and grip force variability in the static phase (expressed as coefficient of variation = standard deviation/mean x 100 [GFV-C]) were calculated during a 15 second period. 5 trials of 20 seconds duration were performed with each hand. The mean changes from Baseline to Day 28 in the grip force variability of each hand are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||percentage of variation||Standard Deviation|Mean
2594603|NCT02231580|Secondary|Change From Baseline to Day 28 in the Orientation-index as Determined by Choreomotography|Choreatic (involuntary) movements were assessed using Choreomotography by calculating a position-index and orientation-index. Patients were asked to grasp and lift a device equipped with an electromagnetic sensor, and were asked to hold the device as stable as possible. 3D changes in position (x, y and z) and orientation (roll, pitch and yaw) were recorded and used to calculate a position-index and an orientation-index. This method provided an objective measure of the involuntary movements. 5 trials of 20 seconds duration were performed with each hand, and the start and end of each trial was signalled by a cueing tone. The mean changes from Baseline to Day 28 in the orientation-index of the right and left hands are presented as raw data. The statistical analyses present GLS mean ratios in the original units.|Baseline (Day -1) to Day 28|The PD population consisted of all subjects from the safety population who have not reported major protocol violations impacting Q-motor evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||radians per second (radians/s)||Standard Deviation|Mean
2594604|NCT02231580|Secondary|Change From Baseline to Day 28 in the Position-index as Determined by Choreomotography|Choreatic (involuntary) movements were assessed using Choreomotography by calculating a position-index and orientation-index. Patients were asked to grasp and lift a device equipped with an electromagnetic sensor, and were asked to hold the device as stable as possible. Three dimensional (3D) changes in position (x, y and z) and orientation (roll, pitch and yaw) were recorded and used to calculate a position-index and an orientation-index. This method provided an objective measure of the involuntary movements. 5 trials of 20 seconds duration were performed with each hand, and the start and end of each trial was signalled by a cueing tone. The mean changes from Baseline to Day 28 in the position-index of the right and left hands are presented as raw data. The statistical analyses present geometric least squares (GLS) mean ratios in the original units.|Baseline (Day-1) to Day 28|The Pharmacodynamic (PD) population consisted of all subjects from the safety population who have not reported major protocol violations impacting quantitative measures of motor function (Q-motor) evaluation and who have a Q-motor evaluation assessed both at Baseline (Day -1) and at one post baseline visit.|||metres per second (m/s)||Standard Deviation|Mean
2594605|NCT02231580|Secondary|Time to Peak Plasma Concentration (Tmax)|Tmax is the empirical time of Cmax and was determined for BN82451B and its metabolites BN2468 and BN7167 on Days 1, 14 and 28. Day 1 data represent the PK after the first dose (Tmax). The data for Days 14 and 28 represent the Tmax at steady state (Tmax,ss) at the initial cohort dose and following dose escalation, respectively. Data is presented for cohorts 1 and 2, as the study terminated prior to dosing of cohort 3.|Days 1, 14 and 28|The PK population consisted of all subjects from the safety population who had no major protocol deviations affecting the PK variables and who had a sufficient number of plasma BN82451B concentrations to estimate the main PK parameters.|||hours||Full Range|Median
2594606|NCT02231580|Secondary|Peak Plasma Concentration (Cmax)|Cmax was determined for BN82451B and its metabolites BN2468 and BN7167 on Days 1, 14 and 28. Day 1 data represent the PK after the first dose (Cmax). The data for Days 14 and 28 represent the Cmax at steady state (Cmax,ss) at the initial cohort dose and following dose escalation, respectively. Data is presented for cohorts 1 and 2, as the study terminated prior to dosing of cohort 3.|Days 1, 14 and 28|The PK population consisted of all subjects from the safety population who had no major protocol deviations affecting the PK variables and who had a sufficient number of plasma BN82451B concentrations to estimate the main PK parameters.|||ng/mL||Standard Deviation|Mean
2594607|NCT02231580|Secondary|Area Under the Plasma Concentration Time Curve (AUC)|The AUC was determined for BN82451B and its metabolites BN2468 and BN7167 within a dosage interval (0-12 hours) on Days 1, and 14 and 28. Day 1 data represent the AUC after the first dose (AUC[0-12]). The data for Days 14 and 28 (AUC[τ,ss]) represent the AUC at steady state at the initial cohort dose and following dose escalation, respectively. Data is presented for cohorts 1 and 2, as the study terminated prior to dosing of cohort 3.|0-12 hours on Days 1, 14 and 28|The PK population consisted of all subjects from the safety population who had no major protocol deviations affecting the PK variables and who had a sufficient number of plasma BN82451B concentrations to estimate the main PK parameters.|||hours*nanograms per millilitre (h*ng/mL)||Standard Deviation|Mean
2594608|NCT02231580|Primary|Numbers of Patients Experiencing Treatment Emergent Adverse Events (TEAEs).|The safety and tolerability of BN82451B versus placebo was determined after oral administration b.i.d. for 28 days in patients with HD. Numbers of patients experiencing TEAEs, including information on seriousness, intensity, drug relationship and those leading to withdrawal are presented for all doses of BN82451B and placebo.|From Day 1 to end of study (a period of up to 7 weeks).|The Safety Population consisted of all randomised patients who received at least one dose of study medication.|||Participants|||Number
2594609|NCT02231177|Secondary|Clinical Relevant Abnormalities in Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG|Clinically relevant abnormalities in vital signs (blood pressure and pulse rate), physical examination, blood chemistry, haematology, urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. Any adverse events which occurred within 14 days following the last drug administration were assigned to the last study treatment administered.|From drug administration until 14 days following the last drug administration|Treated Set. All randomised patients who received at least one dose of trial medication were included in the treated set.|||participants|||Number
2594618|NCT02231177|Secondary|fe(0-24,ss) of Tiotropium|"Fraction of Tiotropium eliminated in urine from 0 to 24 hours at steady state (fe(0-24,ss)).~The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||percentage of tiotropium dose||Geometric Coefficient of Variation|Geometric Mean
2594619|NCT02231177|Secondary|fe(0-24,ss) of Olodaterol|"Fraction of Olodaterol eliminated in urine from 0 to 24 hours at steady state (fe(0-24,ss)).~The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||percentage of olodaterol dose||Geometric Coefficient of Variation|Geometric Mean
2594620|NCT02231177|Secondary|Tmax,ss of Tiotropium|Time from dosing to the maximum concentration of Tiotropium in plasma at steady state (tmax,ss).|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||h||Full Range|Median
2594621|NCT02231177|Secondary|Tmax,ss of Olodaterol|Time from dosing to the maximum concentration of Olodaterol in plasma at steady state (tmax,ss).|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||h||Full Range|Median
2594622|NCT02231177|Secondary|AUC(0-tz,ss) of Tiotropium|"Area under the plasma concentration-time curve at steady state over the time interval from 0 to the time of the last quantifiable data point (AUC(0-tz)) for Tiotropium.~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2594623|NCT02231177|Secondary|AUC(0-tz,ss) of Olodaterol|"Area under the plasma concentration-time curve at steady state over the time interval from 0 to the time of the last quantifiable data point (AUC(0-tz)) for Olodaterol.~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2594624|NCT02231177|Secondary|AUC(0-4h,ss) of Tiotropium|"Area under the concentration time curve of Tiotropium in plasma over the time interval t1=0 to t2=4 h at steady state (AUC(0-4h,ss)).~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2594625|NCT02231177|Secondary|AUC(0-2h,ss) of Olodaterol|"Area under the concentration time curve of Olodaterol in plasma over the time interval 0 to 2 hours at steady state (AUC(0-2h,ss)).~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2594626|NCT02231177|Secondary|Cmax,ss of Tiotropium|"Maximum measured concentration of Tiotropium in plasma at steady state (Cmax,ss).~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2594627|NCT02231177|Secondary|AUC(0-6h,ss) of Tiotropium|"Area under the concentration time curve of Tiotropium in plasma over the time interval t1=0 to t2=6 h at steady state (AUC(0-6h,ss)).~As plasma concentrations were not expected to be quantifiable over the complete dosing interval in all patients, t2 was defined as the time-point where at least 2/3 of the patients reveal quantifiable plasma concentrations of Tiotropium. Based on the given definition AUC(0-6h,ss) was selected as secondary endpoint.~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2594628|NCT02231177|Secondary|Ae(0-24h,ss) of Olodaterol|"Amount of Olodaterol that was eliminated in urine at steady state from time point 0 to 24 h post-inhalation (Ae(0-24h,ss)).~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Intervals 0-4, 4-8, 8-12 and 12-24 hours on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||ng||Geometric Coefficient of Variation|Geometric Mean
2594629|NCT02231177|Primary|Ae(0-24h,ss) of Tiotropium|"Amount of Tiotropium that was eliminated in urine at steady state from time point 0 to 24 h post-inhalation (Ae(0-24h,ss)).~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Intervals 0-4, 4-8, 8-12 and 12-24 hours on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||ng||Geometric Coefficient of Variation|Geometric Mean
2594630|NCT02231177|Primary|Cmax,ss of Olodaterol|"Maximum measured concentration of Olodaterol in plasma at steady state (Cmax,ss).~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic set which is however restricted to patients with evaluable data for this endpoint.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2594631|NCT02231177|Primary|AUC(0-1h,ss) of Olodaterol|"Area under the concentration time curve of Olodaterol in plasma over the time interval t1=0 to t2=1 hour at steady state (AUC(0-1h,ss)).~As plasma concentrations were not expected to be quantifiable over the complete dosing interval in all patients, t2 was defined as the time-point where at least 2/3 of the patients reveal quantifiable plasma concentrations of Olodaterol. Based on the given definition AUC(0-1h,ss) was selected as primary endpoint.~The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA)."|Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.|Pharmacokinetic (PK) set which included all patients in the treated set who provided at least one of the PK parameters in at least one treatment period and completed the trial without any important protocol violations, it is however restricted to patients with evaluable data for this endpoint.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2594632|NCT02231164|Primary|Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1|This outcome measure presents the number of patients with disease control according to RECIST, version 1.1, defined as number of patients with Complete response, partial response or stable disease.|Up to 6 months.|Randomised Set: The randomised set included all randomised patients.|||Percentage of participants|||Number
2594633|NCT02230995|Secondary|AUC0-infinity of Metformin in Plasma|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2594634|NCT02230995|Secondary|AUC0-infinity of Empagliflozin in Plasma|Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS set|||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
2594635|NCT02230995|Primary|Cmax of Metformin in Plasma|Maximum measured concentration of the metformin in plasma|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2594636|NCT02230995|Primary|Cmax of Empagliflozin in Plasma|Maximum measured concentration of empagliflozin in plasma (Cmax)|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2594637|NCT02230995|Primary|AUC0-tz of Metformin in Plasma|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|Pharmacokinetic Set (PKS): This analysis set included all treated subjects that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints.|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
2594638|NCT02230995|Primary|AUC0-tz of Empagliflozin in Plasma|Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)|-1:00 hour(h) before the drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 4:00h, 5:00h, 6:00h, 7:00h, 8:00h, 10:00h, 12:00h, 24:00h, 34:00h, 48:00h and 72:00h after drug administration|PKS set|||nmol·h/L||Geometric Coefficient of Variation|Geometric Mean
2594639|NCT02230956|Secondary|Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale|Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily worst pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.|Baseline, Week 24|Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received.|||score on a scale||Standard Deviation|Mean
2594640|NCT02230956|Secondary|Patient Global Impression of Change (GIC) Using a 7-Point Scale|The participant rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicate worsening and positive scores indicate improvement.|Weeks 1, 4, 8, 12, 16, 20 and 24|"Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2594641|NCT02230956|Secondary|Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale|The WOMAC Physical Function Score consisted of 17 questions about the difficulty of daily activities completed by the participant where: 0=no difficulty to 10=extreme difficulty for a total possible Physical Function Score of 0 (best) to 170 (worst). A negative change from Baseline indicates improvement.|Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24|"Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2594662|NCT02230670|Primary|Change From Baseline at Month 3 in cCK18/M30|Data was log-transformed for analysis purposes|3 months|Full analysis set|||U/L||Standard Error|Least Squares Mean
2594663|NCT02230670|Primary|Change From Baseline at Month 3 in cCK18/M30|Baseline, Month 3, and change between for cCK18/M30|3 months|FAS|||U/L||Full Range|Median
2594642|NCT02230956|Secondary|Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale|The WOMAC Pain Score consisted of 5 questions about pain completed by the participant where: 0=no pain to 10=extreme pain for a total possible Pain Score of 0 (best) to 50 (worst). A negative change from Baseline indicates improvement.|Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24|"Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received. n in the category is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2594643|NCT02230956|Primary|Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale|Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.|Baseline, Week 8|Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received.|||score on a scale||Standard Deviation|Mean
2594644|NCT02230904|Secondary|Change in Average Patch Adhesiveness Score of 2 Days of 24 Hour Patch Application as Rated by the Investigator (or Designee), Assessed According to the FDA/Center for Drug Evaluation and Research (CDER) Score|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:~0 (>95-100% of patch adheres) >> 0 (FDA/CDER)~1 (>90-95% of patch adheres) >> 0 (FDA/CDER)~2 (>85-90% of patch adheres) >> 1 (FDA/CDER)~3 (>80-85% of patch adheres) >> 1 (FDA/CDER)~4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)~5 (>70-75% of patch adheres) >> 2 (FDA/CDER)~6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)~7 (<50 % of patch adheres) >> 3 (FDA/CDER)~8 (Patch completely detached) >> 4 (FDA/CDER)~Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.|||units on a scale||Standard Deviation|Mean
2594645|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2|"The subject assessed the patch adhesiveness by using the following score:~0 = Satisfied with adhesiveness~1 = Moderately satisfied with adhesiveness~2 = Moderately unsatisfied with adhesiveness~3 = Unsatisfied with adhesiveness"|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.|||percentage of patches|Participants||Number
2594646|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1|"The subject assessed the patch adhesiveness by using the following score:~0 = Satisfied with adhesiveness~1 = Moderately satisfied with adhesiveness~2 = Moderately unsatisfied with adhesiveness~3 = Unsatisfied with adhesiveness"|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.|||percentage of patches|Participants||Number
2594647|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 2|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:~0 (>95-100% of patch adheres) >> 0 (FDA/CDER)~1 (>90-95% of patch adheres) >> 0 (FDA/CDER)~2 (>85-90% of patch adheres) >> 1 (FDA/CDER)~3 (>80-85% of patch adheres) >> 1 (FDA/CDER)~4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)~5 (>70-75% of patch adheres) >> 2 (FDA/CDER)~6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)~7 (<50 % of patch adheres) >> 3 (FDA/CDER)~8 (Patch completely detached) >> 4 (FDA/CDER)~Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.|||percentage of patches|Participants||Number
2594648|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 1|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores:~0 (>95-100% of patch adheres) >> 0 (FDA/CDER)~1 (>90-95% of patch adheres) >> 0 (FDA/CDER)~2 (>85-90% of patch adheres) >> 1 (FDA/CDER)~3 (>80-85% of patch adheres) >> 1 (FDA/CDER)~4 ( >75-80% of patch adheres) >> 1 (FDA/CDER)~5 (>70-75% of patch adheres) >> 2 (FDA/CDER)~6 (≥50-70% of patch adheres) >> 2 (FDA/CDER)~7 (<50 % of patch adheres) >> 3 (FDA/CDER)~8 (Patch completely detached) >> 4 (FDA/CDER)~Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.|||percentage of patches|Participants||Number
2594664|NCT02230579|Primary|Half-life of MMV390048|Pk blood collection Investigate the effect of food on the pharmacokinetic and tolerability of the investigational drug in cohort 4 and 8|0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216, 312, 432, 600, 672 hours post-dose|One subject (SAD5 120 mg) was excluded from the PK analysis population due to concomitant use of prohibited medications known to produce drug-drug interactions with pharmacokinetic consequences.|||hours||Full Range|Median
2594649|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).~0 = >95 - 100 % of the patch area adheres~1 = >90 - 95 % of the patch adheres~2 = >85 - 90 % of the patch adheres~3 = >80 - 85 % of the patch adheres~4 = >75 - 80 % of the patch adheres~5 = >70 - 75 % of the patch adheres~6 = ≥50 - 70 % of the patch adheres~7 = <50 % of the patch adheres~8 = Patch completely detached~The recorded scores 6, 7, and 8 were combined in order to create a cumulative group less than or equal to 70 % adhered or patch detachment which was regarded as significant patch adhesion failure in the draft EMA guideline."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.|||percentage of patches|Participants||Number
2594650|NCT02230904|Secondary|Patch Adhesiveness Per Day as Rated by the Investigator or Designee 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 1|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).~0 = >95 - 100 % of the patch area adheres~1 = >90 - 95 % of the patch adheres~2 = >85 - 90 % of the patch adheres~3 = >80 - 85 % of the patch adheres~4 = >75 - 80 % of the patch adheres~5 = >70 - 75 % of the patch adheres~6 = ≥50 - 70 % of the patch adheres~7 = <50 % of the patch adheres~8 = Patch completely detached~The recorded scores 6, 7, and 8 were combined in order to create a cumulative group less than or equal to 70 % adhered or patch detachment which was regarded as significant patch adhesion failure in the draft EMA guideline."|Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.|||percentage of patches|Participants||Number
2594651|NCT02230904|Primary|Change in Average Adhesiveness Score of 2 Days of 24 Hours Patch Application as Rated by the Investigator (or Designee) Assessed According to the EMA Draft Guideline|"The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012).~0 = > 95 - 100 % of the patch area adheres~1 = > 90 - 95 % of the patch adheres~2 = > 85 - 90 % of the patch adheres~3 = > 80 - 85 % of the patch adheres~4 = > 75 - 80 % of the patch adheres~5 = > 70 - 75 % of the patch adheres~6 = ≥ 50 - 70 % of the patch adheres~7 = < 50 % of the patch adheres~8 = Patch completely detached~The recorded scores 6, 7, and 8 were combined in order to create a cumulative group less than or equal to 70 % adhered or patch detachment which was regarded as significant patch adhesion failure in the draft EMA guideline.~The average of patches 1 and 2 is presented by Treatment Arm below."|Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5|Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.|||units on a scale||Standard Deviation|Mean
2594652|NCT02230761|Other Pre-specified|Patient Satisfaction Scale 2 (PSS2)|Composite score on PSS2 scale. PSS2 is an ordinal scale with range 1-7, where 1 is least favorable and 7 is most favorable. The composite score is the sum of 3 items and has a possible response range of 3 to 21.|11 weeks|intention-to-treat|||units on a scale||Standard Deviation|Mean
2594653|NCT02230761|Other Pre-specified|Patient Satisfaction Scale 1 (PSS1)|Change from Baseline to Week 11 in PSS1 score. PSS1 scale items use an ordinal scale with range 0-10, where 0 is the least favorable and 10 is the most favorable. The composite score is the sum of 6 items and has a possible response range of 0 to 60.|0-11 weeks|intention-to-treat|||units on a scale||Standard Deviation|Mean
2594654|NCT02230761|Primary|Lower Eyelid Steatoblepharon Severity (LESS) Score--Clinician-Reported|Photonumeric scale, range 0-4, 0 is absence of steatoblepharon, 4 is very severe steatoblepharon.|11 weeks|intention-to-treat|||participants|||Number
2594655|NCT02230683|Secondary|Concentration of Caspase 3/7 RLU|Median change of concentration of Caspase 3/7 Relative Light Units from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to 28 days/EOT||||RLU||Full Range|Median
2594656|NCT02230683|Secondary|Change in Aspartate Aminotransferase (AST)|Median change of AST from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to 28 days/EOT||||U/L||Full Range|Median
2594657|NCT02230683|Secondary|Change in Alanine Aminotransferase (ALT)|Median change of ALT from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to 28 days/EOT||||U/L||Full Range|Median
2594658|NCT02230683|Primary|Change in cCK18/M30|Median change of caspase-cleaved cytokeratin serum levels (cCK18/M30) from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to Day 28/EOT (end of treatment)||||U/L||Full Range|Median
2594659|NCT02230683|Primary|cCK18/M30|Absolute Mean Change of caspase-cleaved cytokeratin serum levels (cCK18/M30); the statistical analysis is based on the mean change in log-transformed cCK18/M30 from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Change from Baseline to Day 28/EOT||||U/L||Standard Deviation|Mean
2594660|NCT02230683|Primary|Hepatic Venous Pressure Gradient (HVPG)|Mean change of HVPG [mmHg] from Baseline to Day 28/EOT (end of treatment) for IDN-6556|Baseline to Day 28/EOT (end of treatment)|23 subjects were enrolled, of whom 22 were evaluable for the HVPG endpoint. 1 subject discontinued at day 1.|||mmHg||Standard Deviation|Mean
2594661|NCT02230670|Secondary|Change From Baseline to Month 3 in MELD Score|"The Model for End-Stage Liver Disease (MELD) is a scoring system for assessing the severity of chronic liver disease and uses the subject's values for total bilirubin, serum creatinine, and the international normalized ratio (INR) for prothrombin time to predict survival. MELD is calculated according to the following formula:~MELD = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43~MELD scores are reported as whole numbers, so the result of the equation above is rounded. Notes: If the patient has been dialyzed twice within the last 7 days, then the value for serum creatinine used should be 4.0. Any value less than one is given a value of 1 (i.e. if bilirubin is 0.8, a value of 1.0 is used) to prevent the occurrence of scores below 0 (the natural logarithm of 1 is 0, and any value below 1 would yield a negative result). The higher the MELD score the more severe the disease state."|3 Months|FAS|||units on a scale||Standard Error|Least Squares Mean
2608786|NCT02074059|Primary|Serum Electrolytes||24 Hours Post Randomization|All randomized subjects|||mEq/L||Standard Deviation|Mean
2594665|NCT02230579|Secondary|Determine ex Vivo Efficacy (IC50)|Blood collection to determine efficacy of investigational drug against parasites using an ex vivo malaria assay - this was done only for cohort 3 The experimentally obtained bioassay IC50 values were determined and compared to IC50 obtained with reference serum sample spiked with a known amount of MMV390048 titrated into the P. falciparum assay.|up to 144 hr post dose|Samples received from the remaining participants were not processed due to the fact that they were either placebo samples, or failed to reach the pre-determined in vitro IC50 of MMV390048.|||ng/ml||Full Range|Mean
2594666|NCT02230579|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) of MMV390048|Pk blood collection - additional PK point may be planned final visit depending on emerging PK data, unnecessary PK points could be eliminated for the latter cohorts Investigate the effect of food on the pharmacokinetic and tolerability of the investigational drug in cohort 4 and 8|0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, 216, 312, 432, 600, 672 hours post-dose|One subject (SAD5 120 mg) was excluded from the PK analysis population due to concomitant use of prohibited medications known to produce drug-drug interactions with pharmacokinetic consequences.|||h*ng/mL||Full Range|Median
2594667|NCT02230579|Primary|Number of Participants With Adverse Events|Subject will be in-house up to D3, and then have a follow up visit at the site on D5, 7, 10, 14, 19, 26, 29 or longer according to half life|up to D29 or longer according to half life||||Participants|||Count of Participants
2594668|NCT02230566|Secondary|Change From Baseline in Impactful Clinical Problem Total Score at UX003 Treatment Week 24|The 3 most impactful clinical problems as reported by the subject/parent/caregiver during the Clinical Problem Evaluation were scored on a Likert scale from 1 (very little problem) to 7 (an extreme amount) at randomization and post-randomization visits. At post-randomization visits, each clinical problem was again scored for impact on daily activities. Total scores ranged from 3 to 21; lower scores reflect less impact on daily life. Baseline was defined as the last assessment prior to or on the date of cross-over to active treatment with UX003. (This provides the valid assessment, as placebo effect would be subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.) The change from baseline up to UX003 Treatment Week 24 were analyzed by GEE modeling, including baseline value, and the post-UX003 initiation treatment week as a categorical variable. The covariance structure within participants is assumed to be exchangeable.|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo treatment period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||units on a scale||Standard Error|Least Squares Mean
2594669|NCT02230566|Secondary|Percentage of Individual Clinical Response (ICR) Responders at UX003 Treatment Week 24|Percentage of participants who were ICR responders based on MID criteria at Week 24. At the Randomization visit, the physician queried the participant or parent/caregiver about signs and symptoms of MPS VII that interfered most with the participant's daily life. Answers were mapped to an appropriate clinical outcome measure (e.g., difficulty walking could map to the 6MWT; breathing problems to FVC). The clinical outcome ranked with the highest impact on daily life that could be reliably completed by the participant and met a threshold level of impairment was selected as the ICR for that participant. ICR response was assessed based on a positive change (according to pre-specified MID criteria) of each participant's ICR. Agresti-Coull confidence interval with nominal coverage ≥ 95%.|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||percentage of participants||95% Confidence Interval|Number
2594670|NCT02230566|Secondary|Change From Baseline in Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale at UX003 Treatment Week 24|The PedsQL 18-item scale is comprised of 3 dimensions: general fatigue (6 items), sleep/rest fatigue (6 items) and cognitive fatigue (6 items). Each item has a 5-point Likert response scale that is reverse scored and transformed to a 0 to 100 scale with higher scores indicating less fatigue. Baseline was defined as the last assessment prior to or on the date of cross-over to active treatment with UX003. (This provides the valid assessment, as placebo effect would be subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.) Change from baseline in PedsQL total fatigue score was analyzed by GEE modeling based on observed data. The GEE model included all participants who had non-missing baseline and ≥1 post-baseline value during the 24 weeks of UX003 treatment. The model included baseline value, and the UX003 treatment week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo treatment period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||units on a scale||Standard Error|Least Squares Mean
2594682|NCT02230384|Secondary|Number of Participants That Met Criteria for Treatment Emergent Suicidal Ideation or Behavior|"CSSRS: Columbia Suicide Severity rating Scale. The scale assesses treatment emergent suicidal ideation and/or behavior categorically as a YES/NO response (no min/max score). No responses indicate ideation/behaviors did not emerge Yes responses indicate there were ideation or behaviors We are reporting the number of participants that met criteria for suicidal ideation or behavior, based on their CSSRS assessment"|"Every visit up to six weeks. It is only significant when there is a positive response Yes"||||Participants|||Count of Participants
2594683|NCT02230384|Secondary|Monitoring of Psychiatric Symptoms Including Psychopathology|"Psychiatric symptoms using Positive and Negative Syndrome Scale (PANSS) will be conducted at each visit in each 3 week phase of the study~PANSS - Positive and Negative Syndrome Scale. Min value 30, Max value 210, higher scores are worse outcome.~The mean score was used to aggregate across visits."|Once at every scheduled visit||||score on a scale||Standard Deviation|Mean
2594671|NCT02230566|Secondary|Change From Baseline in Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) Scores at UX003 Treatment Week 24|BOT-2 was administered to evaluate treatment-related changes in 4 domains assessing both fine and gross motor function: balance (score 0 to 37), fine motor precision (score 0 to 41), manual dexterity (score 0 to 45), and running speed/agility (score 0 to 52). Higher scores indicate more motor proficiency; a positive change from baseline indicates improvement. Baseline was defined as the last assessment prior to or on the date of cross-over to active treatment with UX003. (This provides the valid assessment, as placebo effect would be subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.) Change from baseline in BOT-2 was analyzed by GEE modeling based on observed data. The GEE model included baseline value, and the UX003 treatment week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo treatment period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||units on a scale||Standard Error|Least Squares Mean
2594672|NCT02230566|Secondary|Change From Baseline in Uncorrected Visual Acuity at UX003 Treatment Week 24|Visual acuity was measured (corrected and uncorrected) using a standard eye chart and recorded for each eye independently. Baseline was defined as the last assessment prior to or on the date of cross-over to active treatment with UX003. The change in the number of lines from pre-treatment baseline to 24 weeks of treatment was evaluated. (This provides the valid assessment, as placebo effect would be subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.) A positive change from baseline indicates improvement. Change from baseline in uncorrected visual acuity was analyzed by GEE modeling based on observed data. The GEE model included all participants who had non-missing baseline and at least one post-baseline value during the 24 weeks of UX003 treatment. The model included baseline value, and the UX003 treatment week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo treatment period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||lines||Standard Error|Least Squares Mean
2594673|NCT02230566|Secondary|Change From Baseline in Shoulder Flexion and Extension Maximum Range of Motion at UX003 Treatment Week 24|Goniometry was used to measure (in degrees) the maximum passive shoulder range of motion in both flexion and extension. Baseline was defined as the last assessment prior to or on the date of cross-over to active treatment with UX003. (This provides the valid assessment, as placebo effect would be subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.) Change from baseline in shoulder flexion-left was analyzed by GEE modeling based on observed data. The GEE model included all participants who had non-missing baseline and at least one post-baseline value during the 24 weeks of UX003 treatment. The model included baseline value, and the UX003 treatment week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo treatment period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||degrees||Standard Error|Least Squares Mean
2594674|NCT02230566|Secondary|Change From Baseline in Pulmonary Function Testing: Maximum Ventilatory Ventilation (MVV) at UX003 Treatment Week 24|Spirometry was administered to participants who did not require invasive ventilatory support or have a tracheostomy to measure MVV. The percent predicted values were calculated after testing using published normative data. Baseline was defined as the last assessment prior to or on the date of cross-over to active treatment with UX003. (This provides the valid assessment, as placebo effect would be subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.)|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|No change from baseline was calculated and no GEE analysis was performed due to lack of data at baseline and/or UX003 Treatment Week 24.||||||
2594675|NCT02230566|Secondary|Change From Baseline in Pulmonary Function Testing: Percentage of Predicted Forced Vital Capacity (FVC%Pred) at UX003 Treatment Week 24|Spirometry was administered to participants who did not require invasive ventilatory support or have a tracheostomy and measured percentage of predicted FVC. The percent predicted values were calculated after testing using published normative data. Baseline was defined as the last assessment prior to or on the date of cross-over to active treatment with UX003. (This provides the valid assessment, as placebo effect would be subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.) No GEE analysis was performed for FVC due to the limitation of the sample size.|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo treatment period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||percentage predicted FVC||Standard Deviation|Mean
2594684|NCT02230384|Secondary|Cognitive Functions|Performance on standardized cognitive tasks (Continuous Performance Task) to determine potential mechanisms of drug efficacy when CO < 10 smoking reduction criteria was met for both sessions. The Continuous Performance Test provides assesses sustained attention in milliseconds.|Assessed at the end of both treatment phases, i.e., at the end of 3 and 6 weeks.|those who met the CO < 10 smoking reduction criteria at the end of both treatment phases|||milliseconds||Standard Error|Mean
2596904|NCT02203578|Primary|Incidence of cGVHD||At 12 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.||||||
2594676|NCT02230566|Secondary|Change From Baseline in 6-Minute Walk Test (6MWT) at UX003 Treatment Week 24|The total distance walked (in meters) in a 6-minute period was measured. Baseline was defined as the last assessment prior to or on the date of cross-over to active treatment with UX003. (This provides the valid assessment, as placebo effect would be subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.) A positive change from Baseline indicates improvement. Change from baseline in 6MWT was analyzed by GEE modeling based on observed data. The GEE model included all participants who had non-missing baseline and at least one post-baseline value during the 24 weeks of UX003 treatment. The model included baseline value, and the UX003 treatment week as a categorical variable. The covariance structure within participants was assumed to be exchangeable.|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo treatment period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||meters||Standard Error|Least Squares Mean
2594677|NCT02230566|Secondary|Multi-Domain Responder Index (MDRI) Score at UX003 Treatment Week 24|MDRI score, calculated as the total response score at UX003 Treatment Week 24 across 6 domains: 6-Minute Walk Test, forced vital capacity predicted value, shoulder flexion, visual acuity, and Bruininks-Oseretsky Test of Motor Proficiency fine motor and gross motor capacity. For each domain, a minimally important difference (MID) was pre-specified. Changes from before treatment (baseline) to 24 weeks after treatment in each domain variable were scored against pre-specified MIDs. (This provides the valid assessment, as placebo effect would be subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.) An improvement or decline ≥ MID was scored either as a +1 or -1, respectively, and a change <MID was scored as 0. The integration of benefit occurred by summing the responses (-1, +1, 0) across all 6 domain variables to derive the MDRI score, with a range of -6 (greatest possible decline) to +6 (greatest possible improvement).|Baseline (defined as the last assessment prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo treatment period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||units on a scale||Standard Deviation|Mean
2594678|NCT02230566|Primary|European Union (EU) and Rest of World: Percentage Change From Baseline in Urinary Glycosaminoglycan (uGAG) Dermatan Sulfate (DS) at UX003 Treatment Week 24|"Baseline was defined as the average of all assessments prior to or on the date of cross-over to active treatment with UX003. (This provides the valid assessment, as placebo effect was subtracted from the treatment effect estimate providing a more conservative assessment of the true treatment effect.) Percent change from baseline in uGAG DS was analyzed by generalized estimating equation (GEE) modeling based on observed data. The GEE model included included baseline value, and the UX003 treatment week as a categorical variable. The covariance structure within subjects was assumed to be exchangeable.~In the United States (US), this was considered a secondary outcome measure. Per guidance from the Food and Drug Administration (FDA), no primary efficacy variable was declared in the US. Efficacy was to be based on the totality of the clinical data on a per participant basis."|Baseline (defined as the average of all assessments prior to or on the date of cross-over to active treatment with UX003) to 24 weeks of UX003 study drug treatment|Participants who had non-missing baseline and ≥1 post-baseline value during 24 weeks of UX003 treatment. Given a randomized blind start and single crossover study design, all 4 groups received a minimum of 24 weeks of UX003 treatment, with a placebo treatment period ranging from 0-24 weeks, by group. Analysis of placebo data was not planned.|||percentage change||Standard Error|Least Squares Mean
2594679|NCT02230540|Primary|Residual Volume Less Than 100ml|"The primary endpoint was Residual volume less than 100 ml (Yes/No) assessed after catheterization when placed at fixed heights (25, 20, 15, 10 and 0 cm) over the wheelchair seat.~Prior to the catheterization corresponding to height 25 cm, a solution was instilled into the bladder to ensure a volume equal to 300 ml. The residual volume at height 25 cm was then calculated as 300 ml minus the volume emptied during catheterization. The residual volume corresponding to height 20 cm was calculated as the residual volume corresponding to height 25 minus the additional volume emptied at height 20. The residual volume corresponding to height 15, 10 and 0 cm were derived similarly.~Calculated residual volumes were negative, likely due to faulty ultrasound scans performed on subjects in sitting position. Consequently, the changes in bladder volumes, re-worded from 300ml - collected volume <100ml to collected volume > 200ml, were used to interpret the primary endpoint."|2-4 hours||||Subjects with successful catheterization|||Number
2594680|NCT02230384|Secondary|The Number of Participants Who Had Treatment Emergent Clinically Significant EKG Results|"EKG measures were done at the screening visit and at the end of study to determine whether there were treatment emergent clinically significant changes in the EKG parameters.~No subjects with abnormal EKGs at baseline were enrolled in the study The data table below shows the number of subjects with clinically significant abnormal EKG results at the end of the study."|Baseline (Week 0) and end of study (week 6)|Intent to treat population (all participants who received at least on dose of intervention)|||Participants|||Count of Participants
2594681|NCT02230384|Secondary|Number of Participants That Had Treatment Emergent Clinically Significant Abnormal Lab Results|"Routine safety labs (included liver and renal labs) were done at baseline, Visit 9, and Visit 18 to determine whether there were treatment emergent clinically significant changes in any of the laboratory parameters. (no subject with abnormal labs at baseline were enrolled in the study) In addition, liver and renal labs were drawn at Visit 4 and Visit 13 to assess for treatment emergent, clinically significant abnormal liver and renal functions.~The reported results in the data table below show the number of subjects that had treatment emergent clinically significant abnormal lab results at any of the time points.~If labs were not within the normal range, they were reviewed by the physician investigators to determine whether they were clinically significant."|Weeks 0, 2, 3, 5, 6|Intent to treat population (all participants who received at least one dose of intervention)|||Participants|||Count of Participants
2594720|NCT02229864|Secondary|Number of Subjects With All Target Lesion Revascularization (TLR)|All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).|0 to 758 Days||||Participants|||Count of Participants
2594685|NCT02230384|Secondary|Withdrawal When Quit|Severity of withdrawal symptoms will be assessed with standard self-report measures each day during the quit week only of each phase. Data will be analysed when quit criteria were met. Scale used was the Minnesota Nicotine Withdrawal Scale (MNWS), ranging from 0 to 100, with higher scores indicating greater levels of withdrawal symptoms. The MNWS was completed 5 times for each participant during the quit week of each phase. The mean score was used to aggregate across visits.|during each quit week|Participants who met CO < 5 ppm quit criterion.|||score on a scale||Standard Error|Mean
2594686|NCT02230384|Primary|Quit Status|"Complete abstinence from smoking for 24 hr, assessed daily from Mon-Fri for just one week. This same Mon-Fri procedure for one week (only) is done for both drug phases (Number of days abstinent per each quit week)~Numbers reported are collapsed across medication conditions for each medication order."|Daily - Mon-Fri during the quit week in each phase|All participants who completed Phase 1 and Phase 2 of the of the study were included in the analysis.|||days abstinent||Standard Error|Mean
2594687|NCT02230332|Other Pre-specified|Fractional Exhaled Nitrix Oxide||8 weeks after randomization||||parts per billion||95% Confidence Interval|Geometric Mean
2594688|NCT02230332|Other Pre-specified|Asthma Control Test (ACT)|Asthma Control Test : Score calculated as the sum total of a 5-item questionnaire. Each item ranges from 1 (poor control) to 5 (good control) so that the range of the total score is 5 to 25. Scores below 20 indicate that asthma is not well controlled.|8 weeks after randomization||||units on a scale||95% Confidence Interval|Mean
2594689|NCT02230332|Other Pre-specified|Salivary Alpha Amylase Ratio (Post-Salmeterol / Pre-Salmeterol)|Salivary Alpha Amylase (sAA) levels from saliva samples obtained through passive drooling, before and 1 hour after Salmeterol administration. The outcome is expressed as the ratio of the Post-Salmeterol to the Pre-Salmeterol sAA levels.|8 weeks after randomization||||ratio||95% Confidence Interval|Mean
2594690|NCT02230332|Secondary|Beta-2 Adrenergic Receptor Agonist-induced cAMP Production|Peripheral blood mononuclear cells cAMP concentrations measured using isoproterenol (ISO) as a beta-2 adrenergic receptor agonist, and using phosphate buffered saline (PBS) as a positive control. The outcome is expressed as the ratio of cAMP concentration using ISO relative to cAMP concentration using PBS.|8 weeks after randomization||||ratio||95% Confidence Interval|Geometric Mean
2594691|NCT02230332|Secondary|Peripheral Blood Mononuclear Cell ADRB2 Cell Surface Density||8 weeks after randomization||||number of receptors per cell||95% Confidence Interval|Geometric Mean
2594692|NCT02230332|Primary|Salmeterol Protected Methacholine Challenge PC20|Following administration of Salmeterol, the concentration of Methacholine required to produce a 20% drop in FEV1 - measured in mg/ml and reported on log base 2 scale.|8 weeks after randomization||||mg/ml on log base 2 scale||95% Confidence Interval|Mean
2594693|NCT02230306|Secondary|Health-related Quality of Life as Measured by The Functional Assessment of Cancer Therapy (FACT) - Brain (FACT-Br)|"The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is used to measure general quality of life (QOL) that reflects symptoms or problems associated with brain malignancies across 5 scales. The brain subscale is usually used along with the core (general) questionnaire that includes 27 items. The measure yields information about total QOL, as well as information about the dimensions of physical well-being, social/family well-being, emotional well being, functional well-being, and disease-specific concerns. Patients rate all 5 items using a five-point Likert scale ranging from 0 not at all to 4 very much. Overall, higher ratings suggest higher QOL. Items are totaled to produce the following subscales, along with an overall QOL score: physical well-being (7 items); social/family well-being (7 items); emotional well-being (6 items); functional well-being (7 items); and concerns relevant to patients with brain tumors (23 items). Scoring range is 0-200."|Up to 5 years||||scores on a scale|||Number
2594694|NCT02230306|Secondary|Early Markers of Progression in Peripheral Blood||Up to 5 years|Zero participants were analyzed for this outcome.||||||
2594695|NCT02230306|Secondary|Immune Modulation in Peripheral Blood||Up to 5 years|Data were not able to be collected and thus zero participants were analyzed for this outcome.||||||
2594696|NCT02230306|Secondary|Duration of Response|Change in relative apparent diffusion coefficient (rADC) as measured by MRI as early predictor of response value/result for each patient|Until disease progression, less than or equal to 5 years.|Patients for whom response duration data was obtainable in those that received MRI tumor assessments every 8 weeks.|||months|||Number
2594697|NCT02230306|Secondary|Overall Survival (OS)|Number of months of survival for individual patients.|Up to 5 years||||months|||Number
2594698|NCT02230306|Secondary|Progression-free Survival (PFS)|Time (number of months) from first documented evidence of overall Complete Response (CR) or Partial Response (PR) until time of first documented disease progression or death due to any cause (for individual patients). Progression as defined by RECIST 1.1 (Response Evaluation Criteria In Solid Tumors) is a ≥ 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.|Up to 5 years|Patients who received study treatment and were assessed by MRI every 8 weeks.|||months|||Number
2594699|NCT02230306|Secondary|Overall Response|Response to study treatment achieved by individual patients as indicated by an overall change in size of the sum of diameters from baseline of up to 5 intracranial target lesions and up to 5 extracranial target lesions.|Until disease progression, less than or equal to 5 years.|Patients who received study treatment and were assessed by MRI every 8 weeks.|||centimeters|||Number
2594700|NCT02230306|Primary|Objective Intracranial Response (OIRR)|Change in overall size of the sum of diameters from baseline of up to 5 intracranial target lesions in response to study treatment, achieved by individual patients.|Until disease progression, less than or equal to 5 years.|Patients who received study treatment and were assessed by MRI every 8 weeks.|||centimeters|||Number
2594701|NCT02230085|Primary|CPAP Therapy Adherence|Adherence is measured by the amount of CPAP use (e.g. good adherence was defined as use of greater than or equal to 70% of nights for greater than 4 hours per night). CPAP data was remotely collected and analyzed from the data reports generated by data collection.|90 days|103 patients CPAP therapy adherence data was collected. 3 patients data was either lost or unable to be downloaded.|||participants|||Number
2594773|NCT02229513|Secondary|Change in Pre- vs Post-operative Hematocrit||48 hours post operative period||||percent||Standard Deviation|Mean
2594702|NCT02229864|Secondary|Number of Subjects With Cumulative Stent/Scaffold Thrombosis (Definite/Probable)|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|0 to 1123 days||||Participants|||Count of Participants
2594703|NCT02229864|Secondary|Number of Subjects With Cumulative Stent/Scaffold Thrombosis (Definite/Probable)|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|0 to 393 days||||Participants|||Count of Participants
2594704|NCT02229864|Secondary|Number of Subjects With Late Stent/Scaffold Thrombosis (Definite/Probable)|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|31 to 393 days||||Participants|||Count of Participants
2594705|NCT02229864|Secondary|Number of Subjects With Subacute Stent/Scaffold Thrombosis (Definite/Probable)|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|>1 to 30 days||||Participants|||Count of Participants
2594706|NCT02229864|Secondary|Number of Subjects With Acute Stent/Scaffold Thrombosis (Definite/Probable)|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: >1 year post stent implantation"|≤ 1 day||||Participants|||Count of Participants
2594707|NCT02229864|Secondary|Number of Subjects With All Revascularization|All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.|0 to 1123 Days||||Participants|||Count of Participants
2594708|NCT02229864|Secondary|Number of Subjects With All Revascularization|All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.|0 to 758 Days||||Participants|||Count of Participants
2594709|NCT02229864|Secondary|Number of Subjects With All Revascularization|All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.|0 to 393 Days||||Participants|||Count of Participants
2594710|NCT02229864|Secondary|Number of Subjects With All Revascularization|All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.|0 to 208 Days||||Participants|||Count of Participants
2594711|NCT02229864|Secondary|Number of Subjects With All Revascularization|All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.|0 to 37 Days||||Participants|||Count of Participants
2594712|NCT02229864|Secondary|Number of Subjects With All Revascularization|All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.|≤ 7 days post index procedure (In-hospital )||||Participants|||Count of Participants
2594713|NCT02229864|Secondary|Number of Subjects With All Target Vessel Revascularization (TVR)|All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).|0 to 1123 Days||||Participants|||Count of Participants
2594714|NCT02229864|Secondary|Number of Subjects With All Target Vessel Revascularization (TVR)|All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).|0 to 758 Days||||Participants|||Count of Participants
2594715|NCT02229864|Secondary|Number of Subjects With All Target Vessel Revascularization (TVR)|All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).|0 to 393 Days||||Participants|||Count of Participants
2594716|NCT02229864|Secondary|Number of Subjects With All Target Vessel Revascularization (TVR)|All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).|0 to 208 Days||||Participants|||Count of Participants
2594717|NCT02229864|Secondary|Number of Subjects With All Target Vessel Revascularization (TVR)|All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).|0 to 37 Days||||Participants|||Count of Participants
2594718|NCT02229864|Secondary|Number of Subjects With All Target Vessel Revascularization (TVR)|All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).|≤ 7 days post index procedure (In-hospital )||||Participants|||Count of Participants
2594719|NCT02229864|Secondary|Number of Subjects With All Target Lesion Revascularization (TLR)|All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).|0 to 1123 Days||||Participants|||Count of Participants
2594721|NCT02229864|Secondary|Number of Subjects With All Target Lesion Revascularization (TLR)|All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).|0 to 393 Days||||Participants|||Count of Participants
2594722|NCT02229864|Secondary|Number of Subjects With All Target Lesion Revascularization (TLR)|All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).|0 to 208 Days||||Participants|||Count of Participants
2594723|NCT02229864|Secondary|Number of Subjects With All Target Lesion Revascularization (TLR)|All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).|0 to 37 Days||||Participants|||Count of Participants
2594724|NCT02229864|Secondary|Number of Subjects With All Target Lesion Revascularization (TLR)|All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).|≤ 7 days post index procedure (In-hospital )||||Participants|||Count of Participants
2594725|NCT02229864|Secondary|Number of Subjects With All Myocardial Infarction (MI)|All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).|0 to 1123 Days||||Participants|||Count of Participants
2594726|NCT02229864|Secondary|Number of Subjects With All Myocardial Infarction (MI)|All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).|0 to 758 Days||||Participants|||Count of Participants
2594727|NCT02229864|Secondary|Number of Subjects With All Myocardial Infarction (MI)|All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).|0 to 393 Days||||Participants|||Count of Participants
2594728|NCT02229864|Secondary|Number of Subjects With All Myocardial Infarction (MI)|All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).|0 to 208 Days||||Participants|||Count of Participants
2594729|NCT02229864|Secondary|Number of Subjects With All Myocardial Infarction (MI)|All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).|0 to 37 Days||||Participants|||Count of Participants
2594730|NCT02229864|Secondary|Number of Subjects With All Myocardial Infarction (MI)|All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).|≤ 7 days post index procedure (In-hospital )||||Participants|||Count of Participants
2594731|NCT02229864|Secondary|Number of Subjects With All Death|All death includes cardiac death, vascular death, and non-cardiac death.|0 to 1123 Days||||Participants|||Count of Participants
2594732|NCT02229864|Secondary|Number of Subjects With All Death|All death includes cardiac death, vascular death, and non-cardiac death.|0 to 758 Days||||Participants|||Count of Participants
2594733|NCT02229864|Secondary|Number of Subjects With All Death|All death includes cardiac death, vascular death, and non-cardiac death.|0 to 393 Days||||Participants|||Count of Participants
2594734|NCT02229864|Secondary|Number of Subjects With All Death|All death includes cardiac death, vascular death, and non-cardiac death.|0 to 208 Days||||Participants|||Count of Participants
2594735|NCT02229864|Secondary|Number of Subjects With All Death|All death includes cardiac death, vascular death, and non-cardiac death.|0 to 37 Days||||Participants|||Count of Participants
2594736|NCT02229864|Secondary|Number of Subjects With All Death|All death includes cardiac death, vascular death, and non-cardiac death.|≤ 7 days post index procedure (In-hospital )||||Participants|||Count of Participants
2594737|NCT02229864|Secondary|Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|0 to 1123 Days||||Participants|||Count of Participants
2594738|NCT02229864|Secondary|Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|0 to 758 Days||||Participants|||Count of Participants
2594739|NCT02229864|Secondary|Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|0 to 393 Days||||Participants|||Count of Participants
2594740|NCT02229864|Secondary|Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|0 to 208 Days||||Participants|||Count of Participants
2594741|NCT02229864|Secondary|Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|0 to 37 days||||Participants|||Count of Participants
2594742|NCT02229864|Secondary|Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR)|Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).|≤ 7 days post index procedure (In-hospital )||||Participants|||Count of Participants
2594743|NCT02229864|Primary|Drug Clearance (CL)|"The systemic drug clearance, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).~Calculated as: CL = Dose/AUC0 - ∞ ."|0 to 30 days||||Liter/hour||Full Range|Median
2594744|NCT02229864|Primary|Terminal Elimination Half-life (t1/2term)|"The apparent terminal elimination half-life, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).~calculated as: t1/2term = 0.693/λz."|0 to 30 days||||Hours||Full Range|Median
2594827|NCT02229227|Secondary|Percentage of Participants Achieving HbA1c <7.0% Without Severe or Documented Symptomatic Hypoglycemia at Week 26|Percentage of participants achieving HbA1c <7.0% without severe or documented symptomatic hypoglycemia are presented.|Week 26|FA Population.|||Percentage of participants|||Number
2594745|NCT02229864|Primary|Terminal Elimination Rate Constant (λz)|The apparent terminal elimination rate constant during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Determined by linear regression of terminal points of the ln-linear analyte concentration-time curve.|0 to 30 days||||1/hour||Full Range|Median
2594746|NCT02229864|Primary|AUC 0-infinity|"AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).~calculated as: AUC0-∞ = AUClast + (Clast/λz)~The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as:~%AUC0-∞ex = (AUC0-∞ - AUClast)/ AUC0-∞ * 100"|0 to 30 days||||ng*h/mL||Full Range|Median
2594747|NCT02229864|Primary|AUC Last|Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated by the Lin Up Log Down trapezoidal method.|0 to 30 days||||ng*h/mL||Full Range|Median
2594748|NCT02229864|Primary|AUC24h|Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS. Calculated by the Lin Up Log Down trapezoidal method.|0 to 24 hours||||ng*h/mL||Full Range|Median
2594749|NCT02229864|Primary|Time of Maximum (Tmax)|Time to reach the maximal observed blood analyte concentration during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).|0 to 30 days||||Hours||Full Range|Median
2594750|NCT02229864|Primary|Maximum Concentration (Cmax)|Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).|0 to 30 days||||nanograms per milliliter||Full Range|Median
2594751|NCT02229539|Secondary|Alternative Analgesics Use in the Continuation Phase||Up to 4 hours post-treatment|||||||
2594752|NCT02229539|Secondary|Pain Score in the Continuation Phase||Up to 4 hours post-treatment|||||||
2594753|NCT02229539|Secondary|The Length of Time in the Continuation Phase||Up to 4 hours post-treatment|||||||
2594754|NCT02229539|Secondary|Patient Preference for Continued Therapy With Oral Rinse After Initial Test Rinse Phase, as Measured by Item 9 in the Patient-reported Questionnaire After 4 Hours||Up to 4 hours post-treatment|||||||
2594755|NCT02229539|Secondary|The Incidence of Using Alternative Analgesics Between 1 and 4 Hours After Initial Mouthwash||Up to 4 hours post-treatment|||||||
2594756|NCT02229539|Secondary|The Total Drowsiness Increase as Measured by the Numerical Analogue Scale of Drowsiness Questionnaires||Up to 4 hours post-treatment every 4 hours while on treatment|||||||
2594757|NCT02229539|Secondary|The Total Stinging or Burning From the Oral Rinse as Measured by the Numerical Analogue Scale of Stinging or Burning From the Oral Rinse in the Questionnaires||Up to 4 hours post-treatment|||||||
2594758|NCT02229539|Secondary|The Total Unpleasant Taste of the Oral Rinse as Measured by the Numerical Analogue Scale of Taste of the Oral Rinse in the Questionnaires||Up to 4 hours post-treatment|||||||
2594759|NCT02229539|Primary|Mean Area Under the Curve (AUC) of Total Pain Reduction|Total pain reduction (mouth and throat) was measured by the numerical analogue scale of mouth pain on a scale of 0 to 10, with 0=no pain and 10=worst pain in the questionnaires taken at baseline, and 5, 15, 30, 60, 120, 240 minutes after assigned treatment for doxepin or DLA vs. placebo. The total pain reduction was calculated by the (average of mouth and throat) area under the curve (AUC) adjusting for baseline, with time scale (baseline, 5, 15, 30, 60, 120 and 240 minutes post treatment) replaced by a numerical scale of 0, 1, 2, 3, 4, 5 and 6 respectively. The AUC was prorated when there are terminal missing data. If the missing data were intermittent, simple imputation by trapezoidal rules were applied to calculate the AUC. If a patient cancelled, was missing baseline data, or only provided baseline data, he/she was excluded from the statistical analysis.|Baseline, 5, 15, 30, 60, 120, 240 minutes post treatment|All participants who met eligibility criteria, had mouth pain score of at least 4 on 0 to 10 scale with higher scores indicated worst pain and started the treatment and had mouth and throat pain data at baseline and at least one time point beyond baseline.|||units on a scale*time scale||Standard Deviation|Mean
2594760|NCT02229513|Secondary|Requirement of Cesarean Hysterectomy||During surgery and in the PACU (approximately 3 total hours)||||participants|||Number
2594761|NCT02229513|Secondary|Total Blood Loss Greater Than 1000 cc||Intra-op, Post-Op||||participants|||Number
2594762|NCT02229513|Secondary|Requirement of Blood Products||During surgery and in the PACU (approximately 3 total hours)||||participants|||Number
2594763|NCT02229513|Secondary|Use of Additional Measures to Control Blood Loss, Including Pharmacological and Surgical Interventions||Intraoperatively||||participants|||Number
2594764|NCT02229513|Secondary|Bakri Bulb Placement||Intraoperatively||||participants|||Number
2594765|NCT02229513|Secondary|Use of Cytotec||Intraoperatively||||participants|||Number
2594766|NCT02229513|Secondary|Use of Hemabate||Intraoperatively||||participants|||Number
2594767|NCT02229513|Secondary|Use of Methergine||Intraoperatively||||participants|||Number
2594768|NCT02229513|Other Pre-specified|Uterine Temperature After Wrap Removed||Immediately following hysterotomy repair||||degrees Fahrenheit||Standard Deviation|Mean
2594769|NCT02229513|Other Pre-specified|Total Time Uterus Wrapped||During hysterotomy repair||||minutes||Standard Deviation|Mean
2594770|NCT02229513|Other Pre-specified|Patient Temperature||Pre-op, Intra-op, Post-Op||||degrees Fahrenheit||Standard Deviation|Mean
2594771|NCT02229513|Secondary|Use of Extra Oxytocin||Intraoperatively||||participants|||Number
2594772|NCT02229513|Secondary|Use of Uterotonic Medications||During surgery and in the PACU (approximately 3 total hours)||||participants|||Number
2594774|NCT02229513|Primary|Blood Loss|At the conclusion of the surgery, blood loss will be calculated by measuring the content of blood in the suction canister, and by weighing the surgical sponges. The amount of blood loss in the PACU will be measured by weighing pads.|During surgery and in the PACU (approximately 3 total hours)||||cc||Standard Deviation|Mean
2594775|NCT02229487|Primary|GLP-1 Levels in Response to Oral Glucose Tolerance Test|Prediabetes patients with and without short sleep will undergo an oral glucose tolerance test with measurement of GLP-1 levels|2 weeks||||pmol/l.h||Inter-Quartile Range|Median
2594776|NCT02229474|Secondary|Zarit Burden Interview|The scale will assess carer burden. There are 22 questions each scored from 0 to 4. Overall, the scale is scored from 0 to 88, with a higher score indicating greater burden.|Immediately post-intervention|people attending CST|||units on a scale||Inter-Quartile Range|Median
2594777|NCT02229474|Secondary|Hospital Anxiety and Depression Scale|The scale will assess anxiety and depression in patients and carers. The maximum possible score is 21 and the minimum score is 0. Lower score indicates lower levels of anxiety and depression.|Immediately post-intervention|People attending CST|||units on a scale||Inter-Quartile Range|Median
2594778|NCT02229474|Secondary|Adapted Alzheimer's Disease Assessment Scale-cognitive Scale|The adapted scale will assess cognitive function, specifically change in function over time. The minimum possible score is 0 and the maximum is 69. A lower score indicates better cognitive function.|Immediately post-intervention|People attending CST|||units on a scale||Standard Deviation|Mean
2594779|NCT02229474|Secondary|Identification and Intervention for Elderly Africans Cognitive Screen|The screen will assess cognitive function. It is scored from a minimum of 0 to a maximum of 15, with a higher score indicating better cognitive function.|Immediately post-intervention|People attending CST|||units on a scale||Inter-Quartile Range|Median
2594780|NCT02229474|Secondary|Zarit Burden Interview|The scale will assess carer burden. There are 22 questions each scored from 0 to 4. Overall, the scale is scored from 0 to 88, with a higher score indicating greater burden.|Baseline|People attending CST|||units on a scale||Inter-Quartile Range|Median
2594781|NCT02229474|Secondary|Hospital Anxiety and Depression Scale|The scale will assess anxiety and depression in patients and carers. The maximum possible score is 21 and the minimum score is 0. Lower score indicates lower levels of anxiety and depression.|Baseline|People attending CST|||units on a scale||Inter-Quartile Range|Median
2594782|NCT02229474|Secondary|Adapted Alzheimer's Disease Assessment Scale-cognitive Scale|The adapted scale will assess cognitive function, specifically change in function over time. The minimum possible score is 0 and the maximum is 69. A lower score indicates better cognitive function.|Baseline|people attending CST|||units on a scale||Standard Deviation|Mean
2594783|NCT02229474|Secondary|Identification and Intervention for Elderly Africans Cognitive Screen|The screen will assess cognitive function. It is scored from a minimum of 0 to a maximum of 15, with a higher score indicating better cognitive function.|Baseline|people attending CST|||units on a scale||Inter-Quartile Range|Median
2594784|NCT02229474|Secondary|World Health Organization Brief Quality of Life Scale|The scale will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale.|Four weeks post intervention|people atending CST sessions|||units on a scale||Inter-Quartile Range|Median
2594785|NCT02229474|Primary|World Health Organization Brief Quality of Life Scale|The WHOQOL-Bref will assess quality of life in patients and carers. The WHOQOL-Bref will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale|Immediately post-intervention|Groups attending CST sessions|||units on a scale||Inter-Quartile Range|Median
2594786|NCT02229474|Primary|World Health Organization Brief Quality of Life Scale|The WHOQOL-Bref will assess quality of life in patients and carers. The scale is scored from a minimum of 4 to a maximum of 20, with higher scores indicating better quality of life. The scores are measured as units on a scale|Baseline|Analysis for QOL data comparing pre- and post intervention scores|||units on a scale||Inter-Quartile Range|Median
2594787|NCT02229461|Secondary|Inhibition of TXB2 Using Platelet-rich Plasma (PRP) on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration|Inhibition of plasma TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.|At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19|Percentages are based on the number of participants in the Evaluable Population in each treatment group. Evaluable participants number in Group 1 at time point Day 7/1 Hour, Day 7/3 Hour, Day 7/6 Hour, Day 7/12 Hour was 12.|||percentage||95% Confidence Interval|Mean
2594788|NCT02229461|Secondary|Inhibition of Arachidonic Acid (AA)-Induced Platelet Aggregation on Days 7, 16, 17, and 19 at 1, 3, 6, 12, 18, and 24 Hours Post IR ASA 81 mg Administration|Inhibition of AA-induced platelet aggregation at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated. The platelet aggregation change-from-baseline scores range broadly in large part due to inclusion of participants with low baseline platelet aggregation scores.|At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19|Percentages are based on the number of participants in the Evaluable Population in each treatment group. Evaluable participants number in Group 4 at time point Day 7/1 Hour was 12; 11 in group 6, 7 in Group 5, 12 in Group 6 at Day 16/1 Hour.|||percentage||95% Confidence Interval|Mean
2594789|NCT02229461|Secondary|Inhibition of Serum TXB2 on Days 7, 16, 17, and 19 of the In-house Treatment Period at 1, 3, 6, 12, 18, and 24 Hours (Except at 24 Hours on Day 16) Post IR ASA 81 mg Administration|Inhibition of serum TXB2 at each time point were calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% CI were calculated.|At 1, 3, 6, 12, 18, and 24 hours on Days 7, 16, 17, and 19 (except 24 hours on Day 16)|Percentages are based on the number of participants in the Evaluable Population in each treatment group.|||percentage||95% Confidence Interval|Mean
2594790|NCT02229461|Primary|Inhibition of Serum Thromboxane B2 (TXB2) on Day 16 at 24 Hour Post IR ASA 81 mg Administration|Inhibition of serum TXB2 at specified time point was calculated using the percentage of reduction from baseline as follows: Inhibition (%) = 100 × (Baseline Value - Post-baseline Value) / Baseline Value. For primary analysis, the mean and the lower bound of the corresponding one-sided 95% Confidence Interval (CI) were calculated.|At hour 24 on Day 16 post treatment|Percentages are based on the number of participants in the Evaluable Population in each treatment group.|||percentage||95% Confidence Interval|Mean
2594791|NCT02229396|Secondary|Change in Systolic Blood Pressure From Baseline to Week 28|To compare the change from baseline to Week 28 in systolic blood pressure between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||millimeters of mercury (mmHg)||95% Confidence Interval|Least Squares Mean
2594792|NCT02229396|Secondary|Percentage of Patients Achieving HbA1c <7% at Week 28|To compare the percentage of patients achieving HbA1c <7% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||% of patients||95% Confidence Interval|Number
2594793|NCT02229396|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 2|To compare the change from baseline to Week 2 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 2|The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||mg/dL||95% Confidence Interval|Least Squares Mean
2594794|NCT02229396|Secondary|Percentage of Patients Achieving Weight Loss ≥5.0% at Week 28|To compare the percentage of patients achieving weight loss ≥5.0% at 28 weeks between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||% of patients||95% Confidence Interval|Number
2594795|NCT02229396|Secondary|Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test|To compare the change from baseline to Week 28 in 2-hour postprandial glucose after a standard Meal Tolerance Test between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||mg/dL||95% Confidence Interval|Least Squares Mean
2594796|NCT02229396|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 28|To compare the change from baseline to Week 28 in fasting plasma glucose between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||milligrams/deciliter (mg/dL)||95% Confidence Interval|Least Squares Mean
2594797|NCT02229396|Secondary|Change in Body Weight From Baseline to Week 28|To compare the change from baseline to Week 28 in body weight between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||kilogram||95% Confidence Interval|Least Squares Mean
2594798|NCT02229396|Primary|Change in HbA1c From Baseline to Week 28|To compare the change from baseline to Week 28 in HbA1c between exenatide once weekly (EQW) 2 mg and dapagliflozin 10 mg administered simultaneously compared to EQW 2 mg alone and dapagliflozin 10 mg alone.|Baseline to Week 28|The ITT analysis set included all randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||% HbA1c||95% Confidence Interval|Least Squares Mean
2594799|NCT02229383|Secondary|Change in Seated Systolic Blood Pressure From Baseline to Week 28|To compare the change from baseline in seated systolic blood pressure achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.|Baseline to Week 28|The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.|||millimeter of mercury||95% Confidence Interval|Least Squares Mean
2594800|NCT02229383|Secondary|Percentage of Participants Achieving HbA1c <7.0% at Week 28, No Weight Gain at Week 28, and No Major Hypoglycemia Over 28 Weeks|To compare the percentage of participants achieving HbA1c <7.0% at Week 28, no weight gain at Week 28, and no major hypoglycemia over 28 weeks between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin.|Baseline to Week 28|The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||Percentage of participants||95% Confidence Interval|Number
2594801|NCT02229383|Secondary|Change From Baseline to Week 28 in Daily Insulin Dose|To compare the change from baseline in daily insulin dose achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.|Baseline to Week 28|The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.|||Units||95% Confidence Interval|Least Squares Mean
2594802|NCT02229383|Secondary|Percentage of Participants Achieving HbA1c <7.0% at Week 28|To compare the percentage of participants achieving HbA1c <7.0% between EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.|Baseline to Week 28|The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment.|||Percentage of participants||95% Confidence Interval|Number
2594803|NCT02229383|Secondary|Change From Baseline to Week 28 in 2-hour Postprandial Glucose After a Standard Meal Tolerance Test (MTT)|To compare the change from baseline in 2-hour postprandial glucose after a standard MTT achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.|Baseline to Week 28|The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.|||milligram per deciliter||95% Confidence Interval|Least Squares Mean
2594804|NCT02229383|Secondary|Change in Body Weight From Baseline to Week 28|To compare the change from baseline in body weight achieved with EQW added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment.|Baseline to Week 28|The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.|||kilogram||95% Confidence Interval|Least Squares Mean
2594805|NCT02229383|Primary|Change in HbA1c From Baseline to Week 28|To compare the change from baseline in HbA1c achieved with exenatide once weekly (EQW) added to titrated basal insulin glargine to placebo added to titrated basal insulin glargine, with or without metformin, after 28 weeks of double-blind treatment. SU= sulfonylurea.|Baseline to Week 28|The ITT analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline HbA1c assessment. Only participants with data available for analysis are presented.|||Percentage of HbA1c||95% Confidence Interval|Least Squares Mean
2594806|NCT02229318|Secondary|Ease of Preparation of FruitiVits|"Ease of preparation of FruitiVits was rated on a scale of 1-5:~(very easy)~(moderately easy)~(neither easy nor difficult)~(moderately difficult)~(very difficult).~Those who considered it not difficult to prepare and scored 1-3 on the scale: 11/11 patients"|Day 8 of trial|Children aged 4 to 8 years.|||participants|||Number
2594807|NCT02229318|Primary|Acceptability of FruitiVits|"The study product was rated on a scale of 1-5:~(liked very much)~(liked moderately)~(neither liked nor disliked)~(disliked moderately)~(disliked very much)."|Day 8 of trial|Children aged 4 to 8 years.|||participants|||Number
2594808|NCT02229227|Secondary|Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters|A single 12-lead ECG recordings were performed in a participant in semi recumbent position for 10 to 15 minutes before obtaining the ECG. Any clinically significant favorable and unfavorable findings are reported.|Up to 30 weeks|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2594809|NCT02229227|Secondary|Number of Participants With Vital Signs of Clinical Concern|Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate values. Assessment of vitals were performed with the participant in a semi recumbent or seated position having rested in this position for at least 5 minutes before each reading. The potential clinical concern values were: SBP: <100 millimeters of mercury (mmHg) and >170 mmHg, DBP: <50 mmHg and >110 mmHg and pulse rate: <50 beats per minute (bpm) and > 120 bpm. Number of participants with vital signs of clinical concern are presented.|Up to 30 weeks|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2594810|NCT02229227|Secondary|Change From Baseline in Total Cholesterol (TC), Low-density Lipoprotein Cholesterol (LDL-c), High Density Lipoprotein (HDL-c), Triglycerides (TG) and Free Fatty Acids (FFA) at Week 10 and Week 26|Lipid parameters included TC, LDL-c, HDL-c, TG and FFA. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. LDL-c and FFA were collected as part of the lipid panel and results were reviewed by investigators for individual participants. Change from Baseline at Week 10 and Week 26 was not assessed for these parameters. Analysis of these parameters was not a specific study objective and would not have any impact on study conclusions. Only those parameters with data values have been presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.|Baseline, Week 10 and Week 26|Safety Population.|||Millimoles per Liters||Standard Deviation|Mean
2594811|NCT02229227|Secondary|Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26|Urine samples were collected for analysis of leukocyte count. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Number of participants with different number of leukocytes in urine at Week 0 and Week 26 are presented.|Week 0 and Week 26|Safety Population.|||Participants|||Number
2594812|NCT02229227|Secondary|Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26|Urine samples were collected for analysis of erythrocyte count. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Number of participants with different number of erythrocytes in urine at Week 0 and Week 26 are presented.|Week 0 and Week 26|Safety Population.|||Participants|||Number
2594813|NCT02229227|Secondary|Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26|Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Safety Population was analyzed. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.|Week 0 and Week 26|Safety Population.|||Participants|||Number
2594814|NCT02229227|Secondary|Mean Specific Gravity at Week 0 and Week 26|Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. A urinary specific gravity measurement is a routine part of urinalysis. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.|Week 0 and Week 26|Safety Population.|||Ratio||Standard Deviation|Mean
2594815|NCT02229227|Secondary|Mean Creatinine at Week 0 and Week 26|Urine samples were collected for analysis of creatinine. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean creatinine at Week 0 and Week 26 are presented.|Week 0 and Week 26|Safety Population.|||Micromoles per Liter||Standard Deviation|Mean
2594816|NCT02229227|Secondary|Mean Albumin at Week 0 and Week 26|Urine samples were collected for analysis of albumin. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean albumin at Week 0 and Week 26 are presented.|Week 0 and Week 26|Safety Population.|||Milligrams per Liter||Standard Deviation|Mean
2594817|NCT02229227|Secondary|Mean Urine Albumin/Creatinine Ratio at Week 0 and Week 26|Urine samples were collected for analysis of albumin/creatinine ratio. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles. Mean urine albumin/creatinine ratio at Week 0 and Week 26 are presented.|Week 0 and Week 26|Safety Population.|||Grams per mole||Standard Deviation|Mean
2594818|NCT02229227|Secondary|Number of Participants With Clinical Chemistry Values of Clinical Concern|Clinical chemistry parameters and their potential clinical concern values were: albumin (>5 g/L above ULN or below LLN), alkaline phosphatase(>3 x ULN), alanine aminotransferase (>3 x ULN), aspartate aminotransferase (>3 x ULN), carbon dioxide content (<16 millimoles per Liter [mmol/L] and > 40 mmol/L), blood urea nitrogen (>2 x ULN), calcium (<1.8 mmol/L and >3.0 mmol/L), chloride (none), creatinine (>159 micromoles/Liter), direct bilirubin (>1.35 x ULN), gamma glutamyl transferase (>3 x ULN), glucose (fasting) (<3 mmol/L and >22 mmol/L), magnesium (<0.411 mmol/L and >1.644 mmol/L), phosphate (>0.323 mmol/L above ULN or below LLN), potassium (>0.5 mmol/L below LLN and >1.0 mmol/L above ULN), sodium (>5 mmol/L above ULN or below LLN), triglycerides (> 9.04 mmol/L), total bilirubin (>1.5 x ULN), total protein (>15 g/L above ULN or below LLN) and uric acid (>654 umol/L). Only those parameters for which at least one value of potential clinical concern was reported are summarized.|Up to 30 weeks|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2594819|NCT02229227|Secondary|Number of Participants With Hematology Values of Clinical Concern|Hematology parameters included basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, monocytes, neutrophils, neutrophil bands, platelets, red blood cell (RBC) count, segmented neutrophils and white blood cell (WBC) count. The potential clinical concern values were: Hematocrit >0.05 below lower limit of normal (LLN) and >0.04 above upper limit of normal (ULN), hemoglobin: >20 grams cells per Liter (g/L) below LLN and >10 g/L above ULN, lymphocytes: <0.5 x LLN, neutrophils: <1 giga cells per liter (GI/L), platelets: <80 GI/L and >500 GI/L, segmented neutrophils: <0.5 x LLN, RBC count: >1 GI/L below LLN and >5 GI/L above ULN and none for basophils, eosinophils, monocytes, neutrophil bands and RBC count. Only those parameters for which at least one value of potential clinical concern was reported are summarized.|Up to 30 weeks|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2594820|NCT02229227|Secondary|Number of Participants With Hypoglycemia With Blood Glucose <56 Milligrams Per Deciliter (mg/dL) (<3.1 Millimoles Per Liter [mmol/L]), Regardless of Symptoms|Number of participants with hypoglycemia with blood glucose <56 mg/dL (<3.1 mmol/L), regardless of symptoms are presented.|Up to Week 26|Safety Population.|||Participants|||Number
2594821|NCT02229227|Secondary|Number of Participants With Daytime and Nocturnal Hypoglycemia|Daytime hypoglycemia was defined as hypoglycemic events with an onset between 06:00 hours and 00:00 hours (inclusive), and nocturnal hypoglycemia (in total and by category), defined as hypoglycemic events with an onset between 00:01 hours and 05:59 hours (inclusive). Number of participants with daytime and nocturnal hypoglycemia (in total and by category) are presented.|Up to Week 26|Safety Population.|||Participants|||Number
2594822|NCT02229227|Secondary|Number of Participants With Hypoglycemic Events (in Total and by Each Category as Defined by the American Diabetes Association Criteria)|The American Diabetes Association has categorized hypoglycemic events as follows: Severe, documented symptomatic, asymptomatic, probably symptomatic and pseudohypoglycemia. Number of participants with hypoglycemic events in total are also presented.|Up to Week 26|Safety Population.|||Participants|||Number
2594823|NCT02229227|Secondary|Percentage of Participants With Events of Hypoglycemia With Confirmed Home Blood Glucose Monitoring and/or Third-party Intervention Through Week 26|Hypoglycemic events with confirmed home plasma glucose monitoring <3.9 millimoles per Liter and/or requiring third party intervention were severe, documented symptomatic (DS) and asymptomatic hypoglycemic events. Participants with more than one hypoglycemic event are counted in all categories reported. Any severe, documented symptomatic, and asymptomatic hypoglycemic events in 3-month intervals (i.e., from Day 0 to Week 12, >Week 12 to Week 26) are presented.|Up to Week 26|Safety Population.|||Percentage of participants|||Number
2594824|NCT02229227|Secondary|Number of Participants With Other AE of Special Interest|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a MP, whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. AE of special interest included hypoglycemic events, cardiovascular events, gastrointestinal events, injection site reactions, potential systemic allergic reactions, pancreatitis, pancreatic cancer, malignant neoplasms following treatment with insulin, diabetic retinopathy events, appendicitis, liver events, pneumonia, and atrial fibrillation/flutter.|Up to Week 26|Safety Population.|||Participants|||Number
2594825|NCT02229227|Secondary|Number of Participants With On-therapy Adverse Events (AE) and Serious AE (SAE), and AE Leading to Discontinuation of Randomized Study Medication|AE is any untoward medical occurrence in a participant, temporally associated with use of medicinal product (MP), whether or not considered related to MP. AE can be any unfavorable, unintended sign (also an abnormal laboratory finding), symptom, or disease (new/exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Safety Population: All participants who received at least 1 dose of randomized study medication. A participant randomized to Albiglutide + Insulin glargine by mistake received Insulin Lispro + Insulin Glargine instead. Since this participant received actual treatment as Insulin Lispro + Insulin Glargine, was summarized as such in Safety Population.|Up to Week 26|Safety Population.|||Participants|||Number
2594826|NCT02229227|Secondary|Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain and Without Severe or Documented Hypoglycemia at Week 26|Percentage of participants achieving HbA1c <7.0% without weight gain and without severe or documented hypoglycemia are presented.|Week 26|FA Population.|||Percentage of participants|||Number
2594829|NCT02229227|Secondary|Total Number of Weekly Insulin Injections to Achieve Glycemic Control at Baseline/Randomization and Week 4, 10, 18, and 26|Total number of weekly insulin injections (7 days) to achieve glycemic control at Baseline/Randomization and Week 4, 10, 18, and 26 are presented. Only those participants available at the specified time points were analyzed represented by n=X,X in category titles.|Baseline (Day -1) and Weeks 4, 10, 18 and 26|FA Population.|||Insulin Injections||Standard Deviation|Mean
2594830|NCT02229227|Secondary|Total Daily Bolus Insulin (Insulin Lispro) at Week 4, 10, 18, and 26 Visits|Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily bolus insulin (insulin lispro) at Week 4, 10, 18, and 26 visits is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.|Weeks 4, 10, 18, and 26|FA Population.|||International Units||Standard Error|Least Squares Mean
2594831|NCT02229227|Secondary|Total Daily Basal Insulin (Insulin Glargine) at Week 4, 10, 18, and 26 Visits|Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily basal insulin (insulin glargine) at Week 4, 10, 18, and 26 visits is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.|Weeks 4, 10, 18, and 26|FA Population.|||International Units||Standard Error|Least Squares Mean
2594832|NCT02229227|Secondary|Total Daily Insulin Dose at Week 4, Week 10 and Week 18|Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily insulin dose at Week 4, Week 10 and Week 18 is presented. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.|Weeks 4, 10, and 18|FA Population.|||International Units||Standard Error|Least Squares Mean
2594833|NCT02229227|Secondary|Number of Participants Meeting Prespecified Criteria for Severe, Persistent Hyperglycemia up to Week 26|Meeting prespecified criteria for severe, persistent hyperglycemia was defined operationally as being withdrawn due to lack of efficacy as recorded on the Treatment Discontinuation and Study Conclusion electronic case report form pages. Number of participants meeting prespecified criteria for severe, persistent hyperglycemia up to Week 26 are presented.|Up to Week 26|FA Population.|||Participants|||Number
2594834|NCT02229227|Secondary|Number of Participants Who Met Prespecified Criteria for Severe, Persistent Hyperglycemia at Week 26|Meeting prespecified criteria for severe, persistent hyperglycemia was defined operationally as being withdrawn due to lack of efficacy as recorded on the Treatment Discontinuation and Study Conclusion electronic case report form pages. Number of participants who met prespecified criteria for severe, persistent hyperglycemia at Week 26 are presented.|Week 26|FA Population.|||Participants|||Number
2594835|NCT02229227|Secondary|Number of Participants Achieving a HbA1c <6.5% up to Week 26|Number of participants achieving a HbA1c <6.5% up to Week 26 are presented.|Up to Week 26|FA Population.|||Participants|||Number
2594836|NCT02229227|Secondary|Number of Participants Achieving a HbA1c <6.5% at Week 26|Number of participants achieving a HbA1c <6.5% at Week 26 are presented.|Week 26|FA Population.|||Participants|||Number
2594837|NCT02229227|Secondary|Number of Participants Achieving HbA1c <7.0% up to Week 26|HbA1c is glycosylated hemoglobin. Number of participants achieving a HbA1c <7.0% up to Week 26 are presented.|Up to Week 26|FA Population.|||Participants|||Number
2594838|NCT02229227|Secondary|Number of Participants Achieving HbA1c <7.0% at Week 26|HbA1c is glycosylated hemoglobin. Number of participants achieving a HbA1c <7.0% at Week 26 are presented.|Week 26|FA Population.|||Participants|||Number
2594839|NCT02229227|Secondary|Change From Baseline to Week 26 in FPG|FPG was measured at Baseline (Day -1) up to Week 26. FPG values for all participants at Week 26 were not collected due to an error in the protocol and were imputed with the FSG values at this time point. The imputation of the FPG at Week 26 from the FSG values was deemed acceptable from the results of the analysis of the correlation between FPG and FSG at the screening visit. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.|Baseline to Week 26|FA Population. Only those participants available at the specified time points were analyzed.|||Millimoles per Liter||Standard Error|Least Squares Mean
2594840|NCT02229227|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|FPG was measured at Baseline (Day -1). FPG values for all participants at Week 26 were not collected due to an error in the protocol and were imputed with the fasting serum glucose (FSG) values at this time point. The imputation of the FPG at Week 26 from the FSG values was deemed acceptable from the results of the analysis of the correlation between FPG and FSG at the screening visit. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.|Baseline and Week 26|FA Population. Only those participants available at the specified time points were analyzed.|||Millimoles per Liter||Standard Error|Least Squares Mean
2594841|NCT02229227|Secondary|Change From Baseline to Week 26 in HbA1c|HbA1c is glycosylated hemoglobin and was measured up to Week 26. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.|Baseline to Week 26|FA Population.|||Percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2594876|NCT02228824|Primary|Change in Cigarette Consumption|Difference in mean daily cigarette consumption between initial two-week baseline period and final two weeks of experimental period, using imputed data|Two-week pre-intervention baseline period compared to final two weeks of 10-week intervention period|All participants who were randomized to an experimental condition (either very-low-nicotine-content cigarettes or normal-nicotine-content cigarettes)|||cigarettes per day||95% Confidence Interval|Least Squares Mean
2594842|NCT02229227|Secondary|Total Daily Insulin Dose at Week 26|Insulin dose at Week 26 was defined as the prescribed insulin dose at Week 25. Based on MMRM model, prescribed total daily basal insulin dose was equal to Baseline prescribed total daily basal insulin dose + treatment + Baseline HbA1c category + region + age category + current use of metformin + visit week + treatment-by-visit week interaction + Baseline prescribed total daily basal insulin dose-by-visit week interaction. Total daily insulin dose at Week 26 is presented. Only those participants available at the specified time points were analyzed.|Week 26|FA Population. Only those participants available at the specified time points were analyzed.|||International Units||Standard Error|Least Squares Mean
2594843|NCT02229227|Secondary|Change From Baseline to Week 26 in Body Weight|Body weight was measured to the nearest 0.1 kilogram on a standard calibrated scale. Participants dressed in light indoor clothes (no coat, jacket, etc.) without shoes and with a voided bladder. The same equipment was used wherever possible. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value. Change from Baseline to Week 26 in body weight are presented. FA Population was analyzed. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.|Baseline (Day -1) to Week 26|FA Population.|||Kilograms||Standard Error|Least Squares Mean
2594844|NCT02229227|Secondary|Change From Baseline in Body Weight at Week 26|Body weight was measured to the nearest 0.1 kilogram on a standard calibrated scale. Participants dressed in light indoor clothes (no coat, jacket, etc.) without shoes and with a voided bladder. The same equipment was used wherever possible. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.|Baseline (Day -1) and Week 26|FA Population. Only those participants available at the specified time points were analyzed.|||Kilograms||Standard Error|Least Squares Mean
2594845|NCT02229227|Secondary|Percentage of Participants With Severe or Documented Symptomatic Hypoglycemia Through Week 26|Severe hypoglycemia was considered as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal was considered sufficient evidence that the event was induced by a low plasma glucose concentration. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <=70 milligrams per deciliters (mg/dL) (<=3.9 millimoles per liters [mmol/L]).|Up to Week 26|FA Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
2594846|NCT02229227|Secondary|Number of Participants Treated With Once-weekly Albiglutide That Were Able to Discontinue Insulin Lispro at Week 4 and Did Not Meet Prespecified Criteria for Severe, Persistent Hyperglycemia Through Week 26|Participants who did not meet prespecified criteria for severe, persistent hyperglycemia through Week 26 were those participants treated with once-weekly albiglutide that were able to replace prandial insulin without lispro re-introduction through Week 26. Number of participants treated with once-weekly albiglutide that were able to discontinue insulin lispro at Week 4 and did not meet prespecified criteria for severe, persistent hyperglycemia through Week 26 have been presented.|Up to Week 26|FA Population.|||Participants|||Number
2594847|NCT02229227|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26|HbA1c is glycosylated hemoglobin. It was measured at Baseline and at Week 26. The analysis was conducted using mixed-effect model with repeated measures (MMRM). The model included HbA1c change from Baseline as the dependent variable; treatment, region, age category, current metformin use, visit week, treatment-by-week interaction, and Baseline HbA1c-by-week interaction as fixed effects; Baseline HbA1c as a continuous covariate; and participant as a random effect. The Baseline value was the last available non-missing value prior to the first dose of the randomized treatment, thus Baseline was Day -1. Change from Baseline is defined as the post-Baseline value minus the Baseline value.|Baseline (Day -1) and Week 26|FA Population. Only those participants available at the specified time points were analyzed.|||Percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2594848|NCT02229214|Secondary|Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to 28 Days After End of Treatment||Baseline, 28 days after end of treatment||||percent of participants|||Number
2594849|NCT02229214|Secondary|Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to End of Treatment||Baseline, end of treatment||||percent of participants|||Number
2594850|NCT02229214|Secondary|Change in Cystatin C From Baseline to 28 Days After End of Treatment||Baseline, 28 days after end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after end of treatment cystatin C measurements.|||mg/L||Standard Error|Mean
2594851|NCT02229214|Primary|Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to 28 Days After End of Treatment|"Method that uses iohexol clearance and body surface area to measure kidney function.~Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR"|Baseline, 28 days after end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after treatment iGFR measurements.|||mL/min/1.73 m^2||Standard Error|Mean
2594852|NCT02229214|Secondary|Change in Cystatin C From Baseline to End of Treatment||Baseline, end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment cystatin C measurements.|||mg/L||Standard Error|Mean
2594853|NCT02229214|Secondary|Change in Serum Creatinine From Baseline to 28 Days After End of Treatment||Baseline, 28 days after end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after end of treatment serum creatinine measurements.|||mg/dL||Standard Error|Mean
2594854|NCT02229214|Secondary|Change in Serum Creatinine From Baseline to End of Treatment||Baseline, end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment serum creatininine measurements|||mg/dL||Standard Error|Mean
2595077|NCT02226965|Secondary|Disease Control Rate|The proportion of patients who have a response of stable disease (SD/no metabolic response [NMR]) or better by investigator assessment|19 months|All enrolled population: All patients who passed the screening in the study|||percentage of participants||95% Confidence Interval|Number
2594855|NCT02229214|Primary|Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment|"Method that uses iohexol clearance and body surface area to measure kidney function.~Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR."|Baseline, end of treatment|The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment iGFR measurements.|||mL/min/1.73 m^2||Standard Error|Mean
2594856|NCT02228980|Other Pre-specified|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine|"Solicited injection site: Tenderness/Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic: Fever, (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability (≤ 23 months); Fever, Headache, Malaise, Myalgia, and Shivering (≥2 years).~Grade 3: Tenderness - Cries if injected limb is moved; Pain - Incapacitating; Erythema, Swelling, Induration, Ecchymosis, ≥ 50 mm or 100 mm age ≥ 12 years: Fever >39.5˚C; Crying abnormal - >3 hours; Drowsiness - Difficulty waking; Appetite lost - Refuses ≥3 meals; Irritability - Inconsolable; Vomiting - ≥6 incidents per 24 hours: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Shivering - Prevents activity (≥ 2 years)"|Day 0 up to Day 7 post any vaccination|Solicited injection site and systemic reactions were assessed in the Safety Population.|||Participants|||Number
2594857|NCT02228980|Other Pre-specified|Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine|Anti hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroconversion was defined as titers < 10 (1/dil) on Day 0 and post vaccination titer ≥ 40 (1/dil) on Day 28 or Day 56 or significant increase was titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-vaccination titer on Day 28 or Day 56.|Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination|Seroconversion or significant increase against the trivalent inactivated influenza vaccine were assessed in the Immunogenicity Analysis Set.|||Percentage of participants|||Number
2594858|NCT02228980|Other Pre-specified|Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine|Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 28 or Day 56.|Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination|Seroprotection against the trivalent inactivated influenza vaccine were assessed in the Immunogenicity Analysis Set.|||Percentage of participants|||Number
2594859|NCT02228980|Primary|Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine|Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique.|Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination|Geometric mean titers against the trivalent inactivated influenza vaccine antigens were assessed in the Immunogenicity Analysis Set.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2594860|NCT02228967|Post-Hoc|Readiness to Change Scale (Analysis III Complete Cases)|A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.|Baseline, Follow-up (Up to 7 months)|Complete case analysis|||units on a scale||Standard Error|Mean
2594861|NCT02228967|Post-Hoc|Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis III Complete Cases)|The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.|Baseline, Follow-up (Up to 7 months)|Complete case analysis|||units on a scale||Standard Error|Mean
2594862|NCT02228967|Post-Hoc|AUDIT-C or Drinkers Index (Analysis III Complete Cases|The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.|Baseline, Follow-up (Up to 7 months)|Complete case analysis|||units on a scale||Standard Error|Mean
2594863|NCT02228967|Post-Hoc|Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis III--complete Cases)|The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.|Baseline, Follow-up (Up to 7 months)|Complete case analysis|||units on a scale||Standard Error|Mean
2594864|NCT02228967|Post-Hoc|Readiness to Change Scale (Analysis II)|A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.|Baseline, Follow-up (Up to 7 months)|For this study, at-risk drinking was defined as: AUDIT total >=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 > 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)|||units on a scale||Standard Error|Mean
2594877|NCT02228720|Secondary|Sino-Nasal Outcome Test (SNOT) 22|Validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a scale of 0 (no problem) to 5 (problem as bad as it can be), resulting in a maximum total score of 110|Baseline, Day 30, Day 90|Adult patients (≥ 18 years of age) diagnosed with chronic sinusitis with or without nasal/sinus polyposis who are candidates for endoscopic sinus surgery and in whom placement of the Propel Nova Sinus Implant is both feasible and medically appropriate|||units on a scale||Standard Deviation|Mean
2596905|NCT02203578|Primary|Incidence of cGVHD||At 9 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.||||||
2594865|NCT02228967|Post-Hoc|Controlled Drinking Self-Efficacy Scale (CDSES) (Analysis II)|The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.|Baseline, Follow-up (Up to 7 months)|For this study, at-risk drinking was defined as: AUDIT total >=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 > 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)|||units on a scale||Standard Error|Mean
2594866|NCT02228967|Post-Hoc|AUDIT-C or Drinkers Index (Analysis II)|The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.|Baseline, Follow-up (Up to 7 months)|For this study, at-risk drinking was defined as: AUDIT total >=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 > 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)|||units on a scale||Standard Error|Mean
2594867|NCT02228967|Post-Hoc|Alcohol Use Disorders Identification Test (AUDIT) Total (Analysis II)|The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.|Baseline, Follow-up (Up to 7 months)|For this study, at-risk drinking was defined as: AUDIT total >=8, under 21 drinker, any past year heavy episodic drinking (HED). Excludes at-risk participants defined as any amount of HED (AUDIT Question 3 > 0) or under 21 drinker at baseline. A total of 281 participants were excluded from this analysis (N = 190)|||units on a scale||Standard Error|Mean
2594868|NCT02228967|Secondary|Readiness to Change Scale|A readiness to change alcohol use measure (ranging from 1 - not ready to change, to 4 - very ready) was assessed at baseline and follow-up for all participants. Because motivation and readiness to change are hallmark elements of the SBIRT approach and are thought to be integral to behavior change, these constructs will be measured to assess the degree to which they change in the two groups. Some individuals may not abstain or reduce their use over time, but there may be an improvement in their readiness to change.|Baseline, Follow-up (Up to 7 months)|Excludes low-risk participants defined as AUDIT <=7 at baseline. A total of 17 participants were excluded from the analysis as they were low-risk at baseline. Additionally, missing data on the Readiness to Change measure resulted in a total of 444 participants for this analysis. Six were missing from usual care and five were missing from SBIRT.|||units on a scale||Standard Error|Mean
2594869|NCT02228967|Secondary|Controlled Drinking Self-Efficacy Scale (CDSES)|The 20-item Controlled Drinking Self-Efficacy Scale (CDSES), is a reliable, valid, easy-to-administer scale that assesses confidence to reduce overall consumption and frequency of drinking. Items range from 0% to 100% with 100% indicating more confidence to engage in controlled drinking. The CDSES was administered at both baseline and follow-up to assess changes in this presumed mediating attitude.|Baseline, Follow-up (Up to 7 months)|Excludes low-risk participants defined as AUDIT <=7 at baseline. A total of 17 participants were excluded from the analysis.|||units on a scale||Standard Error|Mean
2594870|NCT02228967|Secondary|AUDIT-C or Drinkers Index|The drinkers index consists of a summary of the first three AUDIT items which represents a combination of quantity, usual frequency, and frequency of heavy drinking. The AUDIT-C can range from 0 to 12 with 12 representing higher levels of drinking quantity and frequency.|Baseline, Follow-up (Up to 7 months)|Excludes low-risk participants defined as AUDIT <=7 at baseline. A total of 17 participants were excluded from the analysis.|||units on a scale||Standard Error|Mean
2594871|NCT02228967|Primary|Alcohol Use Disorders Identification Test (AUDIT) Total|The primary outcome measure will come from the participant's total score on the AUDIT. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use. Mean AUDIT scores at follow-up will be compared between arms.|Baseline, Follow-up (Up to 7 months)|Excludes low-risk participants defined as AUDIT <=7 at baseline. A total of 17 participants were excluded from the analysis.|||units on a scale||Standard Error|Mean
2594872|NCT02228824|Secondary|Exposure Measure - Cigarette Butt Weight|Mean mass smoked per cigarette (calculated as the starting cigarette weight minus returned butt weight) aggregated for all cigarettes smoked among participants assigned to the very-low-nicotine-content cigarette, compared to those assigned to the normal-nicotine-content cigarette condition.|Entire length of study, through completion, up to 12 weeks|Analysis population consists of those participants who contributed data to the study for (at minimum) the two-week baseline study period block as well as the first two-week block post-randomization|||grams||Standard Error|Least Squares Mean
2594873|NCT02228824|Secondary|Exposure Measure - Cotinine (Logged)|"Cotinine nicotine exposure measure, analyzed from urine samples taken at study office visits~The natural logarithm (ln) of the cotinine measures was used for analysis.~Difference in ln(cotinine) between baseline and end of study, from imputed data"|Post-randomization office visits weeks 2 (end of baseline period) and 12 (end of study)||||log ng/mL||95% Confidence Interval|Mean
2594874|NCT02228824|Secondary|Exposure Measure - Smoking Topography|Difference between average puff volume per cigarette at laboratory smoking topography sessions at study weeks 4, 8, and 12 across all participants, comparing those assigned to the very-low-nicotine-content cigarette condition to those assigned to the normal-nicotine-content cigarette condition. Topography measures were averaged across all time points for each treatment group.|Post-randomization study visits at study weeks 4, 8, 12|Analysis consists of those participants who contributed data to the study through at least study week 4.|||mL||Standard Error|Least Squares Mean
2594875|NCT02228824|Secondary|Exposure Measure - Solanesol|The concentration of solanesol, a stable marker indicator of how much smoke has passed through the filter of a smoked cigarette to the smoker, will be assayed as a measure of smoking intensity. The filter of a cigarette butts smoked during the baseline period will be compared to those smoked during the experimental period.|Post-randomization time points at study weeks 4, 8, 12||||mg/butt||Standard Error|Least Squares Mean
2595528|NCT02221882|Secondary|Number of Participants With Tumor Response|Number of Participants with Tumor Response|Baseline Through Study Completion (Up to 6 Months)|All participants who received at least one dose of study drug and had at least one post-baseline tumor assessment.|||Participants|||Count of Participants
2594878|NCT02228720|Secondary|Degree of Inflammation|Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)|Baseline, Day 30, Day 90|Frontal and maxillary sinus ostia|||units on a scale|Sinuses|Standard Deviation|Mean
2594879|NCT02228720|Secondary|Adhesion/Scarring Grade 2 & 3|Adhesion/scarring grading scale from 0 (No visible granulation/scarring), 1 (Minimal amount of scarring/contraction observed but non-obstructing the frontal or maxillary sinus ostium), 2 (moderate amount of obstructive scar tissue/contraction present in the frontal or maxillary sinus ostium), 3 (Significant scar tissue/ contraction causing obstruction of the frontal or maxillary sinus ostium)|Baseline, Day 30, Day 90|Frontal and maxillary sinus ostia|||percentage of evaluable sinuses|Sinuses||Number
2594880|NCT02228720|Secondary|Ostial Patency|Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed)|Baseline, Day 30, Day 90|Frontal and maxillary sinus ostia|||percentage of evaluable sinuses|Sinuses||Number
2594881|NCT02228720|Primary|Device Placement Success Rate|Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses.|Baseline Procedure|Attempted frontal and maxillary sinus ostia|||Percentage of attempted sinuses|Sinuses||Number
2594882|NCT02228681|Other Pre-specified|Mutation Analysis|To determine if relevant biomarkers correlate with response to treatment in each of the two arms. Unstained sections of tumor tissue and DNA extracted from whole blood will be used for mutational analysis (including PTEN, PIK3CA, KRAS, and CTNNB1 (beta-catenin) performed using a sequencing panel assay.|At study entry|||||||
2594883|NCT02228681|Other Pre-specified|mTOR Pathway Immunohistochemistry|To determine if relevant biomarkers correlate with response to treatment in each of the two arms. Unstained sections of tumor tissue will be used for mTOR pathway (including phosphorylated S6 ribosomal protein, PTEN, total and phosphorylated AKT, total and phosphorylated mTOR, and phospho-ERK1/2) immunohistochemistry|At study entry|||||||
2594884|NCT02228681|Other Pre-specified|Hormone Receptor Immunohistochemistry|To determine if relevant biomarkers correlate with response to treatment in each of the two arms. Unstained sections of tumor tissue will be used for hormone receptor (estrogen receptor-alpha, estrogen receptor-beta, progesterone receptor-A, progesterone receptor B and the G protein-coupled estrogen receptor, GPR-30) immunohistochemistry.|At study entry|||||||
2594885|NCT02228681|Secondary|Median Survival|Survival is defined as the duration alive from study entry until death.|Following treatment discontinuation, patients are followed quarterly for 2 years, semi-annually for 3 more years, annually thereafter.|Eligible patients|||Months||95% Confidence Interval|Median
2594886|NCT02228681|Secondary|Frequency and Severity of CTCAE (Common Toxicity Criteria for Adverse Events) Version 4|Maximum grade of physician assessed adverse events graded and categorized using Common Toxicity Criteria for Adverse Events (CTCAE) version 4|Assessed throughout the treatment period and for 30 days after discontinuation of treatment. Treatment continues until progression of disease.|Eligible and Treated Patients|||Participants|||Count of Participants
2594887|NCT02228681|Secondary|Median Progression-free Survival|Progression-free Survival is defined as the duration alive from study entry until progression is documented, or death; whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.|Tumor measurements were done at 8 and 16 weeks after initiating treatment and then every 12 weeks and compared with baseline measurements prior to treatment. Measurements are continued until disease progression is documented or death.|Eligible Patients|||months||95% Confidence Interval|Median
2594888|NCT02228681|Primary|Frequency of Response|"A confirmed complete or partial response as defined by RECIST 1.1 was considered a response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"|From date of randomization until the date of first documented progression or date of death , up to 3 years.|Eligible and treated participants. One participant in arm II was not treated. Participant flow contains all eligible participants.|||Number of participants|||Number
2594889|NCT02228499|Primary|GPA|To determine the association between asthma and school performance by comparing grade point averages (GPA) in school aged children with and without asthma. We will enroll 200 children in grades 3-8 with asthma (cases) from the ED/IMPACT DC and compare them with a group of 200 children in grades 3-8 without asthma (controls) recruited from the ED. Report cards will be collected between June 2014 and November 1, 2014 or until 200 cases and 200 controls have been recruited, and GPAs will be compared. We expect children with asthma will have lower GPAs . GPAs are unweighted 0-4 scale.|single time point||||GPA(unweighted)||Standard Deviation|Mean
2594890|NCT02228460|Secondary|PK: Renal Clearance (CLR) of GZ/SAR402671 From 0 to 24 Hours|CLR was calculated by dividing the cumulative amount of drug excreted in urine during the dosing interval of 0-24 hours by area under the plasma drug concentration time-curve during the dosing interval of 0-24 hours.|0-24 hours on Day 182|Analysis was performed on PK population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.|||mL/hour||Standard Deviation|Mean
2594891|NCT02228460|Secondary|PK: Percentage of Dose of GZ/SAR402671 Excreted in Urine From 0 to 24 Hours (fe0-24)|fe0-24 was the fraction of dose excreted in urine during the time interval of 0 to 24 hours.|0-24 hours on Day 182|Analysis was performed on PK population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.|||percentage of dose||Standard Deviation|Mean
2594892|NCT02228460|Secondary|PK: Cumulated Amount of GZ/SAR402671 Excreted in Urine From 0 to 24 Hours (Ae0-24)|Ae0-24 was the cumulated amount of study drug excreted in urine during the time interval of 0 to 24 hours.|0-24 hours on Day 182|Analysis was performed on PK population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.|||mcg||Standard Deviation|Mean
2595682|NCT02219282|Secondary|Haemodynamic Response to Insertion of Airway Device.|Mean blood pressure (MBP) (mmHg) were recorded in both groups.|Before anesthesia induction, before laryngeal mask insertion and in the 1st, 2nd, 3rd and 5th minutes after laryngeal mask insertion||||mmHg||Standard Deviation|Mean
2594893|NCT02228460|Secondary|PK: Apparent Volume of Distribution of GZ/SAR402671 (Vss/F) at Steady State|Volume of distribution at steady state was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of drug.|Predose and 1, 2, 4, 8, and 24 hours post-dose on Day 182|Since the percent extrapolation of AUC for all participants was >30%, AUC could not be determined and hence, Vss/F could not be calculated.||||||
2594894|NCT02228460|Secondary|PK: Apparent Total Body Clearance of GZ/SAR402671 at Steady State (CLss/F)|Apparent total body clearance at steady state was a quantitative measure of rate of clearance of drug from the blood following oral administration, and is described in terms of volume of fluid clear of drug per time unit (eg, mL/min).|Predose and 1, 2, 4, 8, and 24 hours post-dose on Day 182|Analysis was performed on PK population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.|||mL/hour||Standard Deviation|Mean
2594895|NCT02228460|Secondary|PK: Terminal Half-life (t1/2z) of GZ/SAR402671|Plasma t1/2z was the time measured for the plasma concentration of drug to decrease by one half. The t1/2z was estimated based on 24-hour post-dose PK.|Day 1 (predose and 1, 2, 4, 8, and 24 hours post-dose); Day 182 (predose and 1, 2, 4, 8, and 24 hours post-dose)|Analysis was performed on PK population. Here, 'number analyzed' = participants with available data at specified time-point.|||hours||Standard Deviation|Mean
2594896|NCT02228460|Secondary|PK: Area Under Plasma Concentration Versus Time Curve From 0 to 24 Hours (AUC0-24) of GZ/SAR402671|Area under the plasma concentration versus time curve of study drug from time 0 to 24 hours (AUC0-24) was calculated using the trapezoidal method over the dosing interval.|Day 1 (predose and 1, 2, 4, 8, and 24 hours post-dose); Day 182 (predose and 1, 2, 4, 8, and 24 hours post-dose)|Analysis was performed on PK population. Here, 'number analyzed' = participants with available data at specified time-point.|||ng*hour/mL||Standard Deviation|Mean
2594897|NCT02228460|Secondary|PK: Time to Reach Maximum Plasma Drug Concentration (Tmax) of GZ/SAR402671|Tmax was defined as time to reach maximum plasma concentration of study drug.|Day 1 (predose and 1, 2, 4, 8, and 24 hours post-dose); Day 182 (predose and 1, 2, 4, 8, and 24 hours post-dose)|Analysis was performed on PK population. Here, 'number analyzed' = participants with available data at specified time-point.|||hours||Full Range|Median
2594898|NCT02228460|Secondary|PK: Plasma Trough Concentration (Ctrough) of GZ/SAR402671|Ctrough was defined as the plasma concentration of study drug observed just before treatment administration during repeated dosing.|Predose on Days 14, 28, 56, 84, 126, and 182|Analysis was performed on PK population. Here, 'number analyzed' = participants with available data at specified time-point.|||ng/mL||Standard Deviation|Mean
2594899|NCT02228460|Secondary|Pharmacokinetics (PK): Maximum Plasma Drug Concentration (Cmax) of GZ/SAR402671|Maximum plasma concentration observed for study drug was reported.|Day 1 (predose and 1, 2, 4, 8, and 24 hours post-dose); Day 182 (predose and 1, 2, 4, 8, and 24 hours post-dose)|Analysis was performed on PK population which included all participants for whom the primary PK data were considered sufficient and interpretable. Here, 'number analyzed' = participants with available data at specified time-point.|||ng/mL||Standard Deviation|Mean
2594900|NCT02228460|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened during on-treatment period (period from the first administration of study drug through the last administration of the study drug plus 30 days or end of study participation for participant, whichever occurs first).|From Baseline up to 212 days|Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2594901|NCT02228460|Secondary|Change From Baseline in Urine Globotriaosylceramide (GL-3) Concentration at Week 26|Change from Baseline in urine GL-3 was obtained by subtracting Baseline value from post-baseline value at Week 26. Concentration of GL-3 in urine was determined using a validated LC-MS/MS method.|Baseline, Week 26|Analysis was performed on FAS. Here, 'overall number of participants analyzed' = participants with available data at both Baseline and Week 26.|||mg/mmol Cr||Standard Deviation|Mean
2594902|NCT02228460|Secondary|Change From Baseline at Week 26 in Skin GL-3 Score in Perineurium Cells: Number of Participants in Categories of Shift in GL-3 Score From Baseline to Week 26|Skin biopsies taken at Baseline and Week 26 were analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Three independent pathologists evaluated each biopsy using an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe), where higher score indicated more severe condition. A single score per participant per time point was derived by taking the score rated by a majority of the pathologists; if a majority score could not be derived, the median score was used. Data were summarized and reported in terms of number of participants with shift from Baseline GL-3 score to Week 26 GL-3 score. Any shift category of Baseline score/Week 26 score that was not observed is not reported. Shift to lower score from Baseline to Week 26 indicates less severe condition at Week 26.|Baseline, Week 26|Analysis was performed on FAS. Here, 'overall number of participants analyzed' = participants with available data at both Baseline and Week 26.|||Participants|||Count of Participants
2594903|NCT02228460|Secondary|Change From Baseline at Week 26 in Skin GL-3 Score in Deep Vessels Smooth Muscle Cells: Number of Participants in Categories of Shift in GL-3 Score From Baseline to Week 26|Skin biopsies taken at Baseline and Week 26 were analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Three independent pathologists evaluated each biopsy using an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe), where higher score indicated more severe condition. A single score per participant per time point was derived by taking the score rated by a majority of the pathologists; if a majority score could not be derived, the median score was used. Data were summarized and reported in terms of number of participants with shift from Baseline GL-3 score to Week 26 GL-3 score. Any shift category of Baseline score/Week 26 score that was not observed is not reported. Shift to lower score from Baseline to Week 26 indicates less severe condition at Week 26.|Baseline, Week 26|Analysis was performed on FAS. Here, 'overall number of participants analyzed' = participants with available data at both Baseline and Week 26.|||Participants|||Count of Participants
2595112|NCT02226198|Secondary|LDL-C From End of Placebo (mg/dL)|Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg|Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)||||mg/dL||Standard Deviation|Mean
2594904|NCT02228460|Secondary|Change From Baseline at Week 26 in Skin GL-3 Score in Deep Vessels Endothelial Cells: Number of Participants in Categories of Shift in GL-3 Score From Baseline to Week 26|Skin biopsies taken at Baseline and Week 26 were analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Three independent pathologists evaluated each biopsy using an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe), where higher score indicated more severe condition. A single score per participant per time point was derived by taking the score rated by a majority of the pathologists; if a majority score could not be derived, the median score was used. Data were summarized and reported in terms of number of participants with shift from Baseline GL-3 score to Week 26 GL-3 score. Any shift category of Baseline score/Week 26 score that was not observed is not reported. Shift to lower score from Baseline to Week 26 indicates less severe condition at Week 26.|Baseline, Week 26|Analysis was performed on FAS. Here, 'overall number of participants analyzed' = participants with available data at both Baseline and Week 26.|||Participants|||Count of Participants
2594905|NCT02228460|Secondary|Change From Baseline in Plasma Glucosylceramide (GL-1) Concentration at Week 26|Change from Baseline in plasma GL-1 was obtained by subtracting Baseline value from post-baseline value at Week 26. Concentration of GL-1 in plasma was determined using a validated LC-MS/MS method.|Baseline, Week 26|Analysis was performed on FAS. Here, 'overall number of participants analyzed' = participants with available data at both Baseline and Week 26.|||mcg/mL||Standard Deviation|Mean
2594906|NCT02228460|Secondary|Change From Baseline in Plasma Lyso Globotriaosylceramide (Lyso-GL-3) Concentration at Week 26|Change from Baseline in plasma Lyso-GL-3 was obtained by subtracting Baseline value from post-baseline value at Week 26. Concentration of lyso-GL-3 in plasma was determined using a validated LC-MS/MS method.|Baseline, Week 26|Analysis was performed on FAS. Here, 'overall number of participants analyzed' = participants with available data at both Baseline and Week 26.|||ng/mL||Standard Deviation|Mean
2594907|NCT02228460|Secondary|Change From Baseline in Plasma GL-3 Concentration at Week 26|Change from Baseline in plasma GL-3 was obtained by subtracting Baseline value from post-baseline value at Week 26. Concentration of GL-3 in plasma was determined using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method.|Baseline, Week 26|Analysis was performed on FAS. Here, 'overall number of participants analyzed' = participants with available data at both Baseline and Week 26.|||mcg/mL||Standard Deviation|Mean
2594908|NCT02228460|Primary|Mean Change From Baseline at Week 26 in Skin GL-3 Score in Superficial Skin Capillary Endothelium|Skin biopsies taken at Baseline and Week 26 were analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Three independent pathologists evaluated each biopsy using an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe), where higher score indicated more severe condition. A single score per participant per time point was derived by taking the score rated by a majority of the pathologists; if a majority score could not be derived, the median score was used. Change from Baseline in GL-3 score was obtained by subtracting Baseline value from post-baseline value at Week 26. A negative change from Baseline indicates less severe condition at Week 26.|Baseline, Week 26|Analysis was performed on FAS. Here, 'overall number of participants analyzed' = participants with available data at both Baseline and Week 26.|||score on a scale||95% Confidence Interval|Mean
2594909|NCT02228460|Primary|Change From Baseline at Week 26 in Skin Globotriaosylceramide (GL-3) Score in Superficial Skin Capillary Endothelium: Number of Participants in Categories of Shift in GL-3 Score From Baseline to Week 26|Skin biopsies taken at Baseline and Week 26 were analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Three independent pathologists evaluated each biopsy using an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe), where higher score indicated more severe condition. A single score per participant per time point was derived by taking the score rated by a majority of the pathologists; if a majority score could not be derived, the median score was used. Data were summarized and reported in terms of number of participants with shift from Baseline GL-3 score to Week 26 GL-3 score. Any shift category of Baseline score/Week 26 score that was not observed is not reported. Shift to lower score from Baseline to Week 26 indicates less severe condition at Week 26.|Baseline, Week 26|Analysis was performed on full analysis set (FAS) that included all participants who received at least 1 dose of study treatment. Here, 'overall number of participants analyzed' = participants with available data at both Baseline and Week 26.|||Participants|||Count of Participants
2594910|NCT02228395|Secondary|Dose Normalized AUCinf (AUCinf[dn])||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2594911|NCT02228395|Secondary|Dose Normalized AUClast (AUClast[dn])||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2594912|NCT02228395|Secondary|Dose Normalized Cmax (Cmax[dn])||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||mg/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2594913|NCT02228395|Secondary|Terminal Elimination Half-Life (t1/2)|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half.|0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hours||Standard Deviation|Mean
2594914|NCT02228395|Secondary|Apparent Volume of Distribution (Vz/F)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||liters||Geometric Coefficient of Variation|Geometric Mean
2594915|NCT02228395|Secondary|Apparent Clearance (CL/F)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||milliliters per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
2594916|NCT02228395|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2594917|NCT02228395|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2594918|NCT02228395|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The PK analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hours||Full Range|Median
2594919|NCT02228395|Secondary|Maximum Observed Plasma Concentration (Cmax)||0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12, 24, 36, 48, 72, 96, 120, 168 and 216 hours post-dose|The pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest in at least 1 treatment period.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2594920|NCT02228395|Primary|Number of Participants With Abnormal Neurological Examination Findings|The extended neurological examination, performed by a board certified neurologist, included observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger nose, heel shin, Romberg, tandem walking, positional and gaze evoked nystagmus, reflexes, muscle strength, cranial nerves, sensory function of upper and lower extremities. The brief neurological examination included an assessment of motor and sensory function, cranial nerves, reflexes, non-cerebellar tremor (eg, resting or positional) and cerebellar function. The assessment of cerebellar function were complemented by the Scale for Assessment and Rating of Ataxia (SARA)|Baseline up to Day 10||||participants|||Number
2594921|NCT02228395|Primary|Number of Participants With Abnormal Physical Examination Findings|A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The brief physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Baseline up to Day 10||||participants|||Number
2594922|NCT02228395|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB)and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (>=)300 milliseconds (msec) or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (=<)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); and QTcF >=450 msec or >=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Baseline up to Day 10|The safety analysis population included all participants who received the study medication; n=number of participants evaluated against criteria.|||participants|||Number
2594923|NCT02228395|Primary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) >=30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mm Hg change from baseline in same posture or DBP <50 mm Hg. IFB = increase from baseline; DFB = decrease from baseline.|Baseline up to Day 10|The safety analysis population included all participants who received the study medication.|||participants|||Number
2594924|NCT02228395|Primary|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin and microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (follicle stimulating hormone [FSH], and urine drug screening).|Baseline up to Day 10|The safety analysis population included all participants who received the study medication.|||participants|||Number
2594925|NCT02228395|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last study drug administration.|The safety analysis population included all participants who received the study medication.|||participants|||Number
2594941|NCT02228174|Secondary|Safety - Percentage of Subjects With Adverse Device Effects (Serious or Non-serious)|Procedure safety was assessed by recording all adverse device effects that occured during or subsequent to treatment on the day of the procedure. Longer-term safety was assessed by recording any untoward medical occurrence since baseline at each follow-up visit.|Each Follow-up Visit through 24 Months|Safety population - all subjects who recieved the Sonata treatment.|||Participants|||Count of Participants
2595113|NCT02226198|Secondary|LDL-C, Not on Apheresis (mmol/L)|Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis|Samples taken at Day 42 (week 6) and Day 84 (week 12)|Patients not treated with apheresis|||mmol/L||Standard Deviation|Mean
2594926|NCT02228395|Primary|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) Post-Baseline|"The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced the following: completed suicide (1), suicide attempt (2) (response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (3)(Yes on preparatory acts or behavior), suicidal ideation (4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)(Yes on Has participant engaged in non-suicidal self-injurious behavior)."|Baseline up to Day 10|The safety analysis population included all participants who received the study medication.|||participants|||Number
2594927|NCT02228174|Secondary|Change in Work Productivity and Activity Impairment Due to Uterine Fibroid Symptoms at 12 Months|The Work Productivity and Activity Impairment questionnaire for a specific health problem (WPAI:SHP) is a standardized instrument for making a quantitative assessment of work impairment and activity impairment attributable to a specific health problem (WPAI:SHP). The assessments are expressed in percentages. The endpoint assessed the difference in these percentages from baseline to 12 months.|Baseline and 12 Months|Subset of the Full Analysis Population who were employed and had paired responses at baseline and 12 months.|||percentage change||Standard Deviation|Mean
2594928|NCT02228174|Secondary|Pregnancy Outcome - Birth Weight|If pregnancy occurred during the study follow-up period, information regarding birth weight was collected.|24 Months|1 subject with pregnancy|||grams|||Number
2594929|NCT02228174|Secondary|Pregnancy Outcome - Gestation Age|If pregnancy occurred during the study follow-up period, information regarding gestation age was collected.|24 Months|1 subject with pregnancy|||weeks|||Number
2594930|NCT02228174|Secondary|Occurrence of Pregnancy|Subjects were asked about the possible occurrence of pregnancy.|All Follow-up Visits through 24 Months|Full Analysis Population (143 subjects).|||Participants|||Count of Participants
2594931|NCT02228174|Secondary|Mean Length of Stay|Length of stay (in hours) was assessed by recording the duration from the start of the procedure to discharge.|Day 0 - Day of Treatment|Safety Population - all treated subjects (147).|||Hours||Standard Deviation|Mean
2594932|NCT02228174|Secondary|Procedure Tolerance|"Prior to discharge, subjects were asked to rate their tolerance of the procedure. The possible responses were very tolerable, moderately tolerable, minimally tolerable, intolerable."|Post-procedure (Day 0)|Safety Population - all treated subjects (147).|||Participants|||Count of Participants
2594933|NCT02228174|Secondary|Subject Pain|Prior to discharge, subjects were asked to rate their experience of pain using a pain Visual Analog Scale (VAS). The VAS for pain is a measurement instrument by which subjects report the intensity of their pain with a quantitative value from 0 (no pain) to 10 (worst pain ever).|Immediately Post-procedure as well as Pre-discharge (Day 0)|Safety Population - all treated subjects (147).|||score on a scale from 0 to 10||Standard Deviation|Mean
2594934|NCT02228174|Secondary|Change in General Health State at 12 Months|Change in general health state was assessed with the EuroQOL EQ-5D. The EQ-5D is a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, EuroQOL EQ-5D provides a simple descriptive profile and a single index value for health status. The EQ-5D consists of five questions that provide a description of the patient's health state with scores ranging from 0 (indicating death) to 1 (indicating perfect health). An increase of 0.04 in EQ-5D is considered by health economists to represent a minimally important difference.|Baseline and 12 Months|Full Analysis Population without imputation for this outcome measure.|||units on a scale||Standard Deviation|Mean
2594935|NCT02228174|Secondary|Subject Willingness to Recommend Procedure at 12 Months|"Subjects were asked whether they would recommend the procedure to a friend with the same health problems. The possible responses were: definitely yes, probably yes, probably no, and definitely no."|12 Months|Full Analysis Population without imputation for this outcome measure.|||Participants|||Count of Participants
2594936|NCT02228174|Secondary|Subject Satisfaction With Treatment at 12 Months|"Subjects were asked to rate their level of satisfaction with the treatment. The possible ratings were as follows: very satisfied, moderately satisfied, somewhat satisfied, somewhat dissatisfied, moderately dissatisfied, and very dissatisfied."|12 Months|Full Analysis Population without imputation for this outcome measure.|||Participants|||Count of Participants
2594937|NCT02228174|Secondary|Overall Treatment Effect (OTE) at 12 Months|The Overall Treatment Effect is a questionnaire for subjects to report their perceived treatment benefit at a given timepoint as either improved, no change, or worsened.|12 Months|Full Analysis Population without imputation for this outcome measure.|||Participants|||Count of Participants
2594938|NCT02228174|Secondary|Time to Return to Normal Activity (RTNA) in Days|Subjects were given a questionnaire at discharge and asked to daily respond to the questionnaire on whether or not they returned to normal activities.|30 Day post-procedure|Full Analysis Population without imputation for this outcome measure.|||Days||Standard Deviation|Mean
2594939|NCT02228174|Secondary|Change in the Symptom Severity Score (SSS) and Quality of Life (HR-QoL) Subscales of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) Questionnaire at 12 Months|The Symptom Severity Score (SSS) and Health-Related Quality of Life Score (HR-QoL) are calculated from a subset of the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) questionnaire, a validated and fibroid-specific assessment tool. The UFS-QoL is a uterine fibroid-specific questionnaire developed to evaluate the symptoms of uterine fibroids and their impact on quality of life related to health. SSS and HR-QoL subscale scores are summed and transformed into a 0-100 point scale. The SSS and HR-QoL subscale scores are inversely related with higher SSS indicating greater symptoms while higher HR-QoL scores indicate better quality of life.|Baseline and 12 Months|Full Analysis Population without imputation for this outcome measure.|||points on a scale||Standard Deviation|Mean
2594940|NCT02228174|Secondary|Percentage Change in Total and Perfused Mean Maximal Fibroid Volumes at 12 Months|The percent change in total and perfused volume of dominant fibroid were determined by comparing contrast-enhanced MRI at baseline and at 12 months.|Baseline and 12 Months|Full Analysis Population without imputation for this outcome measure.|||percentage change||Standard Deviation|Mean
2595683|NCT02219282|Secondary|Oropharyngeal Leak Pressure|Oropharyngeal leak pressure (cm H20) in dentulous and edentulous elderly patients.|Baseline||||cm H20||Standard Deviation|Mean
2594942|NCT02228174|Primary|Percentage of Subjects Without Surgical Re-intervention for Heavy Menstrual Bleeding Due to Treatment Failure|"This endpoint computed the rate of not having a surgical reintervention for heavy menstrual bleeding due to treatment failure. As the success criterion for this endpoint was no surgical reintervention for HMB due to treatment failure at 12 months, the endpoint assessed the rate of subjects without surgical reintervention success due to treatment failure within the 12-month post-treatment period. Rate was calculated using the life-table method."|12 Months|Full Analysis Population (143 subjects)|||Percentage of Participants||95% Confidence Interval|Number
2594943|NCT02228174|Primary|Percentage of Subjects With ≥ 50% Reduction in Menstrual Blood Loss as Assessed by Pictorial Blood Loss Assessment Chart (PBAC)|"The proportion of subjects with a minimum of 50% reduction in menstrual blood loss at 12 months post-procedure compared to baseline as assessed by PBAC. Success for individual subjects was defined as a ≥ 50% reduction from baseline in menstrual blood loss and a final PBAC score < 250. Endpoint success was defined as the lower confidence limit of the percentage of subject success ≥ 45%. The PBAC is a validated tool used to diagnose heavy menstrual bleeding and track menstrual bleeding. Women were asked to record daily use of tampons and sanitary towels by placing a tally mark under the day next to the box that represented how stained the sanitary materials were each time they were changed during the menstrual cycle. The tally marks were added up depending on the saturation level to provide a score. The score does not have an upper limit as it is not a scale. PBAC ≥ 150 is associated with heavy menstrual bleeding."|Baseline and 12 Months|Full Analysis Population (143) minus 1 subject who had surgical reintervention prior to 12 months and was excluded from analysis of bleeding reduction coprimary endpoint per the Statistical Analysis Plan.|||percentage of participants||95% Confidence Interval|Number
2594944|NCT02227862|Secondary|Proportion of Patients With HbA1c < 7%||24 and 52 weeks||||Participants|||Count of Participants
2594945|NCT02227862|Secondary|Change in Cross-reactive Insulin Antibody Percent Binding for Lantus Assay Over Time||24 and 52 weeks||||%SB||Standard Deviation|Mean
2594946|NCT02227862|Secondary|Change in Cross-reactive Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time||24 and 52 weeks||||%SB||Standard Deviation|Mean
2594947|NCT02227862|Secondary|Change in Total Insulin Antibody Percent Binding for Lantus Assay Over Time||24 and 52 weeks||||%SB||Standard Deviation|Mean
2594948|NCT02227862|Secondary|Change in Total Insulin Antibody Percent Binding for Mylan's Insulin Glargine Assay Over Time||24 and 52 weeks||||%SB||Standard Deviation|Mean
2594949|NCT02227862|Secondary|Occurrence of Local and Systematic Reactions||52 weeks||||Number of patients|||Number
2594950|NCT02227862|Secondary|Hypoglycemia Occurrence||52 weeks||||Number of patients|||Number
2594951|NCT02227862|Secondary|Rate of Hypoglycemic Events Per 30 Days Over Time||24 and 52 weeks||||Episodes/30 Days||Standard Deviation|Mean
2594952|NCT02227862|Secondary|Change in Total Daily Insulin Dose Per Unit Body Weight From Baseline Over Time||24 and 52 weeks||||U/Kg||Standard Deviation|Mean
2594953|NCT02227862|Secondary|Change From Baseline in 8-point SMBG Profile Over Time||24 and 52 weeks||||mmol/L||Standard Deviation|Mean
2594954|NCT02227862|Secondary|Change From Baseline in FPG Over Time||24 and 52 weeks||||mmol/L||Standard Deviation|Mean
2594955|NCT02227862|Secondary|Summary of Actual and Change From Baseline in HbA1c||24 and 52 weeks||||percent||Standard Deviation|Mean
2594956|NCT02227862|Primary|Change in HbA1c From Baseline to 24 Weeks||24 weeks||||percent||Standard Error|Least Squares Mean
2594957|NCT02227849|Secondary|Change in Blood Pressure||Baseline, 52 Weeks|Full analysis set, last observation carried forward.|||mmHg||Standard Deviation|Mean
2594958|NCT02227849|Secondary|Percentage Change in Body Weight||Baseline, 52 Weeks|Full analysis set, last observation carried forward. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.|||percent change||Standard Deviation|Mean
2594959|NCT02227849|Secondary|Change in Fasting Plasma Glucose||Baseline, 52 Weeks|Full analysis set, last observation carried forward. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.|||mg/dL||Standard Deviation|Mean
2594960|NCT02227849|Secondary|Change in Percentage of HbA1c||Baseline, 52 Weeks|Full analysis set, last observation carried forward.|||percentage of HbA1c||Standard Deviation|Mean
2594961|NCT02227849|Primary|Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)||52 Weeks||||Participants|||Count of Participants
2594962|NCT02227836|Primary|Sensitivity of Patch Testing|Sensitivity of the patch test will be defined by the number of subjects with total positive APT reactions correlated to histologic findings|up to 120 hours after application of patch test||||Participants|||Count of Participants
2594963|NCT02227810|Secondary|Hospitalization Outcomes|The total days that participants stay in the respiratory care center (RCC).|the day participants were discharged from RCC|t test|||days||Standard Deviation|Mean
2594964|NCT02227810|Primary|Pulmonary Function|The pulmonary function as assessed by the measurement of tidal volume.|end of intervention|t -test|||ml||Standard Deviation|Mean
2594965|NCT02227810|Primary|Muscle Strength|The muscle strength of quadriceps were assessed by Medical Research Council (MRC) scoring system. The MRC score ranges from a 0 points (zero strength) to 5 points (good). The higher points indicated the better muscle strength.|end of intervention||||units on a scale||Standard Deviation|Mean
2594966|NCT02227810|Primary|Level of Activity of Daily Life|The level of activity of daily life was measured by Functional Independence Measure (FIM) score. Possible scores range from 18 (total assist) to 126 (complete independence).|end of intervention||||units on a scale||Standard Deviation|Mean
2594967|NCT02227784|Secondary|Percent Change From Baseline to 3 Months in Lipoprotein(a) (Lp[a])|Change in Lp(a) levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.|Baseline, 3 Months|All randomized participants who had evaluable Lp(a) data.|||percent||95% Confidence Interval|Median
2595744|NCT02218424|Secondary|Postoperative Pain Medication|Amount of rescue postoperative pain medication needed in the recovery room will be tabulated.|90 minutes||||mg IV morphine||Inter-Quartile Range|Median
2594968|NCT02227784|Secondary|Percent Change From Baseline to 3 Months in Cholesterol Efflux Capacity|Change in cholesterol efflux capacity from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.|Baseline, 3 Months|All randomized participants who had evaluable cholesterol efflux capacity|||percent||95% Confidence Interval|Median
2594969|NCT02227784|Secondary|Percent Change From Baseline to 3 Months in Apolipoprotein B (apoB)|Change in apoB levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.|Baseline, 3 Months|All randomized participants who had evaluable apoB data.|||percent||95% Confidence Interval|Median
2594970|NCT02227784|Secondary|Percent Change From Baseline to 3 Months in Non-HDL-C|Change in Non-HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure.|Baseline, 3 Months|All randomized participants who had evaluable non-HDL-C data.|||percent||95% Confidence Interval|Median
2594971|NCT02227784|Secondary|Percent Change From Baseline to 3 Months in Apolipoprotein AI (apoAI)|Change in apoAI levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. LS means and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.|Baseline, 3 Months|All randomized participants with evaluable apoAI data.|||percent||95% Confidence Interval|Median
2594972|NCT02227784|Secondary|Percent Change From Baseline to 3 Months in High-Density Lipoprotein Cholesterol (HDL-C)|Change in HDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LS medians and median differences were analyzed in log units and converted to standard units. Statistics are from mixed model repeated measures analysis with log baseline measurement, treatment, visit, and treatment by visit interaction included in the model. Log percent change from baseline response is the dependent variable. Within-participant repeated measures at multiple visits are modeled by a compound symmetry covariance structure.|Baseline, 3 Months|All randomized participants who had evaluable HDL-C data.|||percent||95% Confidence Interval|Median
2594973|NCT02227784|Primary|Percent Change From Baseline to 3 Months in Low-Density Lipoprotein Cholesterol (LDL-C)|Change in LDL-C levels from baseline to the 3-month visit expressed as a percentage of the baseline levels. LDL-C was measured by beta quantification. Statistics are from analysis of covariance with log baseline measurement and treatment is included in the model. Least Square Means (LS means) and median differences were analyzed in log units and converted to standard units. Log Percent change from baseline response is the dependent variable.|Baseline, 3 Months|All randomized participants who had evaluable LDL-C data|||percent||95% Confidence Interval|Median
2594974|NCT02227758|Primary|Quality of Life|Patients for who the physician reported the change in overall quality of life of the patient since the implant with greatly improved or improved. Physicians were asked about the change in overall quality of life of the patient(Greatly improved, improved, neither improved or deteriorated, deteriorated, greatly deteriorated)|3 months|84 subjects had available data for physician reported overall quality of life|||Participants|||Count of Participants
2594975|NCT02227758|Primary|Quality of Life|Patients who reported the change in overall quality of life since the implant with greatly improved or improved. Patients were asked about their change in overall quality of life (Greatly improved, improved, neither improved or deteriorated, deteriorated, greatly deteriorated)|3 months|83 subjects had available data for Quality of life at the 3 month follow-up visit.|||Participants|||Count of Participants
2594976|NCT02227758|Primary|Physician Satisfaction|Patients for who the physician is very satisfied or satisfied with the patient headache relief since the implant. Physicians were asked about their satisfaction (very satisfied, satisfied, neither satisfied or dissatisfied, unsatisfied, very unsatisfied)|3 months|84 subjects had available data for physician satisfaction at the 3 month follow-up visit.|||Participants|||Count of Participants
2594977|NCT02227758|Primary|Patient Satisfaction|Patients very satisfied or satisfied with the headache relief since the implant. Patients were asked about their satisfaction (very satisfied, satisfied, neither satisfied or dissatisfied, unsatisfied, very unsatisfied)|3 months|84 subjects had available data for patient satisfaction at the 3 month follow-up visit.|||Participants|||Count of Participants
2594978|NCT02227758|Primary|Migraine Disability|Percentage change in Midas score from Baseline to 3 Months. The Midas questionnaire consists out of 5 questions to be answered by the patient. Three questions address the number of missed days due to headache in school or paid work, household work and family, social or leasure activities. The two remaining questions document the number of additional days with significant limitations to activity (defined as at least 50% reduced productivity) in the domains of employment and household work. The total score is the sum of days completed for questions 1-5. Midas score ranges from 0 to 21+ with higher values indicating greater disability.|3 months|63 patients had available data for all 5 questions of the Midas questionnaire computing the total score at the 3 month follow-up visit. Excluding the outliers, 59 patients had available data.|||percentage of change||Standard Deviation|Mean
2594979|NCT02227758|Primary|Headache Days|Percentage change in number of Headache days from Baseline to 3 Months. Headache days are the amount of days the subject had an headache in the previous 3 months as captured by the MIDAS questionnaire.|3 months|69 patients had available data for headache days in the previous 3 months at the 3 month follow-up visit|||percent change in headache days||Standard Deviation|Mean
2595075|NCT02226965|Secondary|Progression-free Survival|The number of months from C1D1 until the date of DLBCL progression or death from any cause, or to the last date at which progression status was adequately assessed for censored observation|19 months|All enrolled population: All patients who passed the screening in the study|||months||95% Confidence Interval|Median
2594980|NCT02227758|Primary|Headache Pain Relief|"Patient reported headache pain relief in percentage for the previous month; patients were asked about their pain relief in percentage in the previous month; patient were asked in the last month, how much headache relief has the implant provided (0% represents no relief, 100% represents complete relief)"|3 months|82 patients had available data for pain relief in the previous month at the 3 month follow-up visit|||percentage pain relief||Full Range|Mean
2594981|NCT02227758|Primary|Adverse Events (First 12 Weeks)|Events were classified as hardware related when a malfunction or migration of any device component including leads, extensions, IPG's, occurred. Events will classified as biological in cases where there was a biological reaction (hematoma, pain, etc.) to either the device or the surgical procedure to implant the device. Events were classified as stimulation related if the event was known to be caused by stimulation.|3 months||||events|||Number
2594982|NCT02227693|Other Pre-specified|Number of Participants With Markedly Abnormal Electrocardiographs||From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)|The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||Participants|||Count of Participants
2594983|NCT02227693|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values||From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)|The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||Participants|||Count of Participants
2594984|NCT02227693|Other Pre-specified|Number of Participants With Clinically Significant Findings in Laboratory Values for Urinalysis||From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)|The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||Participants|||Count of Participants
2594985|NCT02227693|Other Pre-specified|Number of Participants With Clinically Significant Findings in Laboratory Values for Serum||From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)|The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||Participants|||Count of Participants
2594986|NCT02227693|Other Pre-specified|Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Value (TEMAV) for Haematology||From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)|The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||Participants|||Count of Participants
2594987|NCT02227693|Other Pre-specified|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Safety assessments consisted of monitoring and recording all AEs and SAEs, regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms; physical examinations; and Doppler sonography. AE severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death related to the AE. All AEs graded as 4 or 5 were considered to be serious. A treatment-emergent adverse event (TEAE) was defined as an AE that started on or after the date of first dose of study drug, up to 30 days after the last dose of study drug. For each category, a participant with two or more adverse events in that category was counted only once. Treatment-related TEAEs were considered by the investigator to be possibly or probably related to study drug or TEAEs with a missing causality.|From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months|Safety Analysis Set included all participants who received at least one dose of study drug and had at least one safety assessment.|||Participants|||Count of Participants
2594988|NCT02227693|Secondary|Platelet Count and Change From Baseline in Platelet Count by Visit||Baseline, Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)|FAS|||Number of platelets x 10^9/L||Standard Deviation|Mean
2594989|NCT02227693|Secondary|Percentage of Participants With Platelet Count Greater Than or Equal to 200 x 10^9/L At Each Visit|Responders were defined as the participants whose platelet count greater than or equal to 200 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis.|Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)|FAS|||Percentage of participants|||Number
2594990|NCT02227693|Secondary|Percentage of Participants With Platelet Count Greater Than or Equal to 150 x 10^9/L At Each Visit|Responders were defined as the participants whose platelet count greater than or equal to 150 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis.|Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)|FAS|||Percentage of participants|||Number
2594991|NCT02227693|Secondary|Percentage of Participants With Platelet Count Greater Than or Equal to 75 x 10^9/L at Each Visit|Responders were defined as the participants whose platelet count greater than or equal to 75 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% CI is calculated by Clopper and Pearson method.|Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)|FAS|||Percentage of participants||95% Confidence Interval|Number
2594992|NCT02227693|Secondary|Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L at Each Visit|Responders were defined as the participants whose platelet count greater than or equal to 50 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% CI is calculated by Clopper and Pearson method.|Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)|FAS|||Percentage of participants||95% Confidence Interval|Number
2595008|NCT02227316|Primary|Evaluation of Maximum Pain Intensity Change Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen|Primary efficacy objective is to compare the change in maximum level of pain experienced by patient over 24 hours between IV acetaminophen and IV ibuprofen (alone and in combination), and the current standard of care medication regimen. This comparison will be measured using a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.|24 hours||||units on a scale||Standard Deviation|Mean
2594993|NCT02227693|Primary|Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L and at Least 20 x 10^9/L Increase From Baseline at Visit 4|Responders were defined as participants whose platelet count was greater than or equal to 50×10^9/liter (L) and change from baseline was at least 20×10^9/L at Visit 4. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% confidence interval (CI) is calculated by Clopper and Pearson method.|Baseline and Visit 4 (Day 10)|Full Analysis Set (FAS) included all randomized participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2594994|NCT02227485|Primary|Modified Gingival Index|"0= Absence of inflammation~Mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary~Mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary~moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary~severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration"|At the beginning, after 2 weeks and after 4 weeks.|The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.|||units on a scale||Standard Deviation|Mean
2594995|NCT02227485|Primary|Pocket Depth|It is the depth of the dental sulcus which detected by measuring the depth of sulcular insertion of the probe at six sites; mesiofacial, midfacial, distofacial, mesiolingual, midlingual and distolingual of all teeth divided by the teeth number. the measurement unit is millimeter (mm).|At the beginning, after 2 weeks and after 4 weeks|The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.|||mm||Standard Deviation|Mean
2594996|NCT02227485|Secondary|Satisfaction of Patients|"We use a Visual Analogue Scale (VAS) to evaluate the patients' satisfaction and their tolerance.~This VAS ranged from 1 (not satisfied at all) to 5 (fully satisfied) was used:~Not satisfied at all~Not satisfied adequately~Not good-Not bad (So So)~Mostly Satisfied~Fully satisfied"|Up to 2 week||||participants|||Number
2594997|NCT02227485|Secondary|Number of Participants With Adverse Events||Up to 2 weeks||||participants|||Number
2594998|NCT02227485|Primary|Bleeding Index|"presence of bleeding of the gum when probing it: 0= No bleeding~1= Bleeding occurs within 10 seconds after gentle probing of the orifice of the gingival crevice"|At the beginning, after 2 weeks and after 4 weeks.|The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.|||units on a scale||Standard Deviation|Mean
2594999|NCT02227485|Primary|Plaque Index|"0 No plaque~A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which cannot be seen with the naked eye. But only by using disclosing solution or by using probe.~Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye.~Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin."|At the beginning, after 2 weeks and after 4 weeks|The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.|||units on a scale||Standard Deviation|Mean
2595000|NCT02227368|Secondary|Change From Baseline in Log Transformed Claudication Onset Time (COT) at Week 26 or Early Termination (ET)||26 Weeks|ITT population is the analysis population. Twelve subjects without evaluable baseline were excluded from the analysis.|||log(Second)||95% Confidence Interval|Mean
2595001|NCT02227368|Primary|Change From Baseline in Log Transformed Peak Walking Time (PWT) at Week 26 or Early Termination (ET)||26 Weeks|ITT population is the analysis population. Six subjects without evaluable baseline were excluded from the analysis.|||log(Second)||95% Confidence Interval|Mean
2595002|NCT02227329|Primary|Number of Catheter-Related Blood Stream Infections|The most common complication in parenteral nutrition is catheter-related blood stream infection (CRBSI), which can lean to increased morbidity, mortality, and prolonged hospitalizations. CRBSI was defined as bacteremia or fungemia in a patient who had an intravascular device and >1 positive blood culture result obtained from the peripheral vein, clinical manifestations of infection (e.g., fever, chills, and/or hypotension), and no apparent source for blood stream infection other than the central venous catheter.|1 year||||infections|||Number
2595003|NCT02227316|Secondary|Maximum Nausea Intensity|Assessment of maximum level of nausea experienced by patient, by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category.|24 hours||||units on a scale||Standard Deviation|Mean
2595004|NCT02227316|Secondary|Anti-Emetic Consumption|Mean dose of anti-emetic medication in milligrams given over 24 hours|24 hours||||Milligrams||Standard Deviation|Mean
2595005|NCT02227316|Secondary|Opioid Consumption|Mean opioid consumption in morphine equivalents over 24 hours|24 hours||||Morphine equivalent||Standard Deviation|Mean
2595006|NCT02227316|Secondary|Mean Nausea Intensity|Assessment of mean nausea by mean of VAS scores over a 24-hour period. VAS score is measured using a scale of 0 to 10, 0 signifying no nausea and 10 signifying the worst possible nausea. The scores reported are the mean of all patients' VAS scores in each respective category.|24 hours||||units on a scale||Standard Deviation|Mean
2595007|NCT02227316|Primary|Evaluation of Mean Pain Intensity Over 24 Hours With the Addition of IV Acetaminophen and IV Ibuprofen|Primary efficacy objective is to compare the change in mean pain intensity score over 24 hours between IV acetaminophen and IV ibuprofen (alone and in combination), and the current standard of care medication regimen. This comparison will be measured using a visual analog scale (VAS) from 0 to 10, 0 signifying no pain and 10 signifying the worst possible pain. The scores reported are the mean of all patients' VAS scores in each respective category.|24 hours||||units on a scale||Standard Deviation|Mean
2595074|NCT02226965|Secondary|Safety - Assessment of Adverse Events|Characterization of the type, frequency, severity, timing of onset, duration, and relationship to study drug of any treatment-emergent adverse events, laboratory abnormalities, serious adverse events or adverse events leading to discontinuation of study treatment|36 months|Safety population: All patients who received at least 1 dose of PNT2258|||participants reporting at least 1 AE|||Number
2595009|NCT02227238|Secondary|Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8)|Treatment compliance was evaluated through MMAS-8. It is an eight-item self-reported measure of medication-taking behavior. The score ranges from 0-8 where scores of 8 indicate high or near perfect adherence, and scores of less than 6 indicate poor or inadequate adherence on the MMAS-8 scale. Number of participants showing low, medium and high adherence to treatment are presented. Low adherence is a score 0-5.75, medium adherence is a score of 6-7.75 and high adherence is a score of 8. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). The analysis was performed using LOCF dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.|Up to Week 48|ITT-E Population|||Participants|||Count of Participants
2595010|NCT02227238|Secondary|Change From Baseline in Treatment Satisfaction, Using the HIV-Treatment Satisfaction Questionnaire (HIVTSQ) Score|The HIVTSQ is a self-reported scales that measure overall satisfaction with treatment. The score ranges from 0-10. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). The analysis was performed using LOCF dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.|Baseline, Week 4, Week 24, Week 48|ITT-E Population|||Scores on a scale||Inter-Quartile Range|Median
2595011|NCT02227238|Secondary|Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score|The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. The scale ranges from 1= no discomfort to 7= very severe discomfort. Higher scores show greater severity of symptoms. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). The analysis was performed using Last Observation Carried Forward (LOCF) dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.|Baseline, Week 4, Week 24, Week 48|ITT-E Population|||Scores on a scale||Inter-Quartile Range|Median
2595012|NCT02227238|Secondary|Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Drug-related Diarrhea|Number of participants who experienced maximum grade 2 or greater toxicity post-Baseline in drug-related diarrhea was summarized. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.|Week 24 and Week 48|Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.|||Participants|||Count of Participants
2595013|NCT02227238|Secondary|Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol|Blood samples were collected from participants in fasting state at indicated time-points to evaluate LDL cholesterol. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Number of participants who experienced maximum grade 2 or greater toxicity post-Baseline in fasting LDL cholesterol was summarized. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening.|Up to Week 48|Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.|||Participants|||Count of Participants
2595014|NCT02227238|Secondary|Change From Baseline in Fasting Total Cholesterol/HDL Cholesterol Ratio|Blood samples were collected from participants in fasting state to evaluate total cholesterol/HDL cholesterol ratio. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only participants available at the time of evaluation were analyzed. Analysis was performed using multiple imputation with missing at random assumption. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population.|Baseline, Week 24 and Week 48|Safety Population|||Ratio||Standard Error|Mean
2595015|NCT02227238|Secondary|Change From Baseline in Fasting LDL Cholesterol at Week 24 and Week 48|Blood samples were collected from participants in fasting state to evaluate LDL cholesterol. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Analysis was performed using multiple imputation with missing at random assumption. Only participants available at the time of evaluation were analyzed. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.|Baseline, Week 24 and Week 48|Safety Population|||Millimoles per liter||Standard Error|Mean
2595016|NCT02227238|Secondary|Number of Participants Who Discontinued Treatment Due to AEs|Number of participants who discontinued study treatment due to AEs or SAEs were summarized.|Up to Week 52|Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.|||Participants|||Count of Participants
2595017|NCT02227238|Secondary|Number of Participants With Hematology Toxicities|Number of participants with hematology toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Lipids and glucose parameters were summarized on fasting data. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population.|Up to Week 52|Safety Population|||Participants|||Count of Participants
2595039|NCT02227147|Secondary|Patients Experiencing Deterioration|Number of patients experiencing deterioration (increase in lesion size ≥ 1mm and/or decrease in BCDVA by >5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters and/or progression in lesion depth to corneal melting or perforation and/or onset of infection) in stage 2 or 3 NK from baseline to Week 8.|from baseline to Week 8.|ITT population. As far as this endpoint is concerned, data are available (non-missing) for 18 patients out of 24 in the rhNGF group, and for 15 patients out of 24 for the vehicle group.|||Number of subjects|||Number
2595018|NCT02227238|Secondary|Change From Baseline in Erythrocyte Values|Blood samples were collected from participants to evaluate clinical hematology parameters including erythrocyte. Change from Baseline in erythrocyte values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.|Baseline and up to Week 52|Safety Population|||10^12 cells/liter||Standard Deviation|Mean
2595019|NCT02227238|Secondary|Change From Baseline in Mean Corpuscular Volume (MCV)|Blood samples were collected from participants to evaluate clinical hematology parameters including MCV. Change from Baseline in MCV values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.|Baseline and up to Week 52|Safety Population|||Femtoliter||Standard Deviation|Mean
2595020|NCT02227238|Secondary|Change From Baseline in Hemoglobin Values|Blood samples were collected from participants to evaluate clinical hematology parameters including hemoglobin. Change from Baseline in hemoglobin values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.|Baseline and up to Week 52|Safety Population|||Gram per liter||Standard Deviation|Mean
2595021|NCT02227238|Secondary|Change From Baseline in Hematocrit Values|Blood samples were collected from participants to evaluate clinical hematology parameters including hematocrit. Change from Baseline in hematocrit values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.|Baseline and up to Week 52|Safety Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
2595022|NCT02227238|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes|Blood samples were collected from participants to evaluate clinical hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Change from Baseline in clinical hematology parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.|Baseline and up to Week 52|Safety Population|||10^9 cells/liter||Standard Deviation|Mean
2595023|NCT02227238|Secondary|Number of Participants With Clinical Chemistry Toxicities|Number of participants with clinical chemistry toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Lipids and glucose parameters were summarized on fasting data. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population.|Up to Week 52|Safety Population|||Participants|||Count of Participants
2595024|NCT02227238|Secondary|Change From Baseline in Lipase Values|Blood samples were collected from participants to evaluate clinical chemistry parameters including lipase. Change from Baseline in lipase at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.|Baseline and up to Week 52|Safety Population|||Unit per liter||Standard Deviation|Mean
2595025|NCT02227238|Secondary|Change From Baseline in Creatinine and Bilirubin Values|Blood samples were collected from participants to evaluate clinical chemistry parameters including creatinine and bilirubin. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.|Baseline and up to Week 52|Safety Population|||Micromoles per liter||Standard Deviation|Mean
2595026|NCT02227238|Secondary|Change From Baseline in Albumin Values|Blood samples were collected from participants to evaluate clinical chemistry parameters including albumin. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.|Baseline and up to Week 52|Safety Population|||Gram per liter||Standard Deviation|Mean
2595027|NCT02227238|Secondary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values|Blood samples were collected from participants to evaluate clinical chemistry parameters including ALP, ALT, AST and creatine kinase. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.|Baseline and up to Week 52|Safety Population|||International unit per liter||Standard Deviation|Mean
2595028|NCT02227238|Secondary|Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides|Blood samples were collected from participants to evaluate clinical chemistry parameters including glucose, chloride, carbon-di-oxide (CO2), potassium, phosphate, sodium, urea, cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. Lipid parameters were evaluated in fasting condition. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.|Baseline and up to Week 52|Safety Population|||Millimoles per liter||Standard Deviation|Mean
2595029|NCT02227238|Secondary|Number of Participants With Non-serious Adverse Events (AEs) With >=2% Frequency Threshold and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Safety Population was used which comprised of all participants who received at least one dose of study treatment. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population.|Up to Week 52|Safety Population|||Participants|||Count of Participants
2595030|NCT02227238|Secondary|Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline|Number of participants with fold change in treatment-emergent phenotypic resistance from Baseline to DTG, LPV/RTV was counted to assess the development of viral resistance. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Change in grade 0 to >2 from Baseline is presented. Analysis was performed on viral phenotypic Population, which comprised of all participants in the ITT-E Population with available On-treatment phenotypic resistance data at the time confirmed virologic withdrawal criterion is met.|Baseline and up to Week 52|Viral Phenotypic Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.|||Participants|||Count of Participants
2595031|NCT02227238|Secondary|Number of Participants With Treatment-emergent Genotypic Resistance|Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI), NRTI, Protease inhibitor (PI) were summarized. On-treatment Genotypic Resistance Population comprised of all participants in the ITT-E population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.|Up to Week 52|Viral genotypic Population|||Participants|||Count of Participants
2595032|NCT02227238|Secondary|Number of Participants With Disease Progression|Disease progression included HIV-associated conditions, acquired immune deficiency syndrome (AIDS) and death. Number of participants with disease progression to Centers for Disease Control and Prevention (CDC) class C or death have been presented.|Up to Week 52|ITT-E Population|||Participants|||Count of Participants
2595033|NCT02227238|Secondary|Change From Baseline in Helper-inducer T-lymphocyte Having Surface Antigen Cluster of Differentiation (CD4+) Cell Count at Weeks 24 and 48|Blood was collected and CD4+ cell count assessment was carried out at indicated time points to evaluate the immunological activity of DTG compared to LPV/RTV. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline, Week 24 and Week 48|ITT-E Population|||Cells per cubic millimeter (Cells/mm^3)||Inter-Quartile Range|Median
2595034|NCT02227238|Secondary|Time to Viral Suppression at Week 48|Viral suppression was defined as HIV-1 RNA <50 c/mL. Time to viral suppression was analyzed and median and interquartile range has been presented.|Week 48|ITT-E Population|||Days||Inter-Quartile Range|Median
2595035|NCT02227238|Secondary|Percentage of Participants Without Virologic or Tolerability Failure at Week 24 and Week 48|Virologic or tolerability failure was defined as treatment-related discontinuation (meeting confirmed virologic withdrawal criteria, treatment-related adverse event, safety stopping criteria, and lack of efficacy). Percentage of participants without virologic failure by Week 24 and Week 48 have been presented. Participants who did not met the protocol defined confirmed virologic withdrawal criteria and are ongoing in the study, or who had discontinued for non-treatment related reasons were censored.|Week 24 and Week 48|ITT-E Population|||Percentage of participants|||Number
2595036|NCT02227238|Secondary|Percentage of Participants With Plasma HIV-1 RNA <400 c/mL at Weeks 24 and 48|Percentage of participants with plasma HIV 1 RNA < 400 c/mL at Week 24 and 48 using the FDA snapshot algorithm were evaluated.|Week 24 and Week 48|ITT-E Population|||Percentage of participants|||Number
2595037|NCT02227238|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24|Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to demonstrate the non-inferior activity of DTG plus 2 NRTI's compared to LPV/RTV plus 2 NRTI's.|Week 24|ITT-E Population|||Percentage of participants|||Number
2595038|NCT02227238|Primary|Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies Per Milliliter (c/mL) at Week 48|Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior activity of DTG plus 2 NRTI's compared to LPV/RTV plus 2 NRTI's. Analysis was performed on Intent-to-treat exposed (ITT-E) Population, which comprised of all randomized participants who received at least one dose of study medication.|Week 48|ITT-E Population|||Percentage of participants|||Number
2595072|NCT02226965|Secondary|Duration of Overall Response|The time from the initial CMR or PMR until the date of progression or death from any cause, or to the last date at which progression status was adequately assessed for censored observations|19 months|All enrolled population: All patients who passed the screening in the study|||months||Full Range|Median
2595040|NCT02227147|Secondary|Improvement in Corneal Sensitivity|"Improvement in corneal sensitivity was measured by the Cochet-Bonnet aesthesiometer at 4, 6 and 8 weeks.~Corneal sensitivity is measured continuously in each patient in cm:~Area of the Persistent Epithelial Defect (PED) or corneal ulcer~All quadrants, but outside the PED or corneal ulcer area: Superior nasal, inferior nasal, superior temporal, inferior temporal.~Improvement is defined as an increase of at least 0.5 cm in the location of concern."|At 4, 6 and 8 weeks after start of the treatment|ITT population|||cm||Standard Deviation|Mean
2595041|NCT02227147|Secondary|Percentage of Patients That Achieve a 15 Letter Gain in BCDVA|Percentage of patients that achieve a 15 letter gain in Best Corrected Distance Visual Acuity (BCDVA) at 4 weeks, 6 weeks, 8 weeks|Weeks 4, week 6 and week 8|LOCF, ITT population|||percentage of subjects|||Number
2595042|NCT02227147|Secondary|Mean Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA)|"Change in Best Corrected Distance Visual Acuity (BCDVA) from baseline to Week 8.~Best Corrected Distance Visual Acuity consists of letters read at 4m only."|Baseline, Week 8|LOCF, ITT Population|||letters read correctly||Standard Deviation|Mean
2595043|NCT02227147|Secondary|Percentage of Patients With Complete Corneal Clearing|Percentage of patients with complete corneal clearing at weeks 4, 6, and 8 defined as grade 0 on the modified Oxford scale. Grade 0 indicates the absence of conjunctival staining; grade V indicates severe conjunctival staining.|at weeks 4, 6, and 8|LOCF, ITT population. Two patients (randomized to rhNGF although not eligible) had no post-baseline data, were assumed to be missing, and were excluded from the analyses.|||percentage of participants|||Number
2595044|NCT02227147|Secondary|Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by Central Reading Center and Investigator.|Percentage of patients experiencing complete healing of the PED or corneal ulcer at 4, and 6 weeks as measured by the central reading center evaluating the clinical pictures and investigator.|At weeks 4 and 6|LOCF, ITT population. One patient (randomized to rhNGF although not eligible) had no post-baseline data, was assumed to be missing, and was excluded from the analyses.|||percentage of participants|||Number
2595045|NCT02227147|Secondary|Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by the Investigator|Percentage of patients experiencing complete healing of the PED or corneal ulcer determined by corneal fluorescein staining at 8 weeks as measured by the investigator.|Week 8|ITT population, LOCF. One patient (randomized to rhNGF although not eligible) had no post-baseline data, was assumed to be missing, and was excluded from the analyses.|||percentage of participants|||Number
2595046|NCT02227147|Primary|Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer Defined by Central Reviewer|Percentage of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining at 8 weeks as defined by the central reading center on clinical pictures.|Week 8|ITT population, LOCF. One patient (randomized to rhNGF although not eligible) had no post-baseline data, was assumed to be missing, and was excluded from the analyses.|||percentage of participants|||Number
2595047|NCT02227121|Primary|Defibrillation Outcome|Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system.|Day of procedure|Only subjects with ventricular fibrillation successfully induced were eligible for analysis|||Participants|||Count of Participants
2595048|NCT02227108|Secondary|Systemic Clearance (CL) After the First Dose of Cycle 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]).|Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1|"Safety population who provided at least one measurable Pharmacokinetic concentration. Here, number of participants analysed, N included evaluable participants for this outcome measure."|||milliliter per hour per kilogram||Full Range|Mean
2595049|NCT02227108|Secondary|Terminal Phase Elimination Half Life (t1/2) After the First Dose of Cycle 1|Terminal phase elimination half-life is the time measured for the serum/plasma concentration to decrease by one half, calculated as natural logarithmic (log)-transformed (ln) value of 2 divided by elimination rate constant (lambda); that is [ln(2)/lambda]. Elimination rate constant (lambda) was estimated via linear regression of the time versus log concentration.|Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1|"Safety population who provided at least one measurable Pharmacokinetic concentration. Here, number of participants analysed, N included evaluable participants for this outcome measure."|||hour||Full Range|Median
2595050|NCT02227108|Secondary|Time to Reach Maximum Drug Concentration in Plasma (Tmax) After the First Dose of Cycle 1|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1|Safety population who provided at least one measurable Pharmacokinetic concentration.|||hour||Standard Deviation|Mean
2595051|NCT02227108|Secondary|Maximum Observed Drug Concentration in Plasma (Cmax) After the First Dose of Cycle 1|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1|Safety population who provided at least one measurable Pharmacokinetic concentration.|||nanogram per milliliter||Standard Deviation|Mean
2595052|NCT02227108|Secondary|Area Under the Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration [AUC0-last] After the First Dose of Cycle 1|AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC0-t is defined as AUC from time zero to the last data point above the lower limit of quantification.|Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion at Day 1 of Cycle 1|"Safety population who provided at least one measurable Pharmacokinetic concentration. Here, number of participants analysed, N included evaluable participants for this outcome measure."|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
2595073|NCT02226965|Secondary|Overall Survival|The number of months from C1D1 until the date of death from any cause, or to the last date at which survival status was adequately assessed for censored observations|19 months|All enrolled population: All patients who passed the screening in the study|||months||Full Range|Median
2595053|NCT02227108|Secondary|Area Under the Plasma Concentration Time Curve From Time 0 to Infinity (AUC0-inf) After the First Dose of Cycle 1|AUC (0-infinity) = Area under the serum concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-infinity). It is obtained from AUC (0-t) plus AUC (tinfinity). It was calculated by extrapolating the concentrationtime curve from time zero to infinity using the linear/log trapezoidal rule.|Pre-infusion, end of infusion (EOI); 1, 3, and 6 hours post-infusion of Day 1 of Cycle 1|"Safety population who provided at least one measurable Pharmacokinetic concentration. Here, number of participants analysed, N included evaluable participants for this outcome measure."|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
2595054|NCT02227108|Secondary|Number of Participants With Positive Anti-drug Antibody (ADA) and Neutralizing Antibodies (NAb)|Immunogenicity assessment included determination of antidrug (moxetumomab pasudotox) antibodies and neutralizing antidrug antibodies in serum samples. Titers and specificity were determined for NAb-positive participants. Specificity were observed in participants who had ADAs directed to the PE38 domain of moxetumomab pasudotox and increase in titers were observed in participants who tested ADA-positive at baseline. Moxetumomab pasudotox ADA-titer is a validated immunoassay, which determines titers or levels of ADAs present in ADA-positive samples.|Prior to the Start of Each Cycle for Cycles 1, 2, 3, and Subsequent Odd-Numbered Cycles, End of Treatment, and 30 Day Follow-up Visit, up to 1 year|"Safety population includes all participants who received any amount of moxetumomab pasudotox. Here, number of participants analysed, N included participants with at least one post-baseline sample."|||participants|||Number
2595055|NCT02227108|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Participants who experienced vital signs abnormalities recorded as TEAEs were reported.|Baseline up to 30 days after the last dose of study drug, up to 1 year|Safety population includes all participants who received any amount of moxetumomab pasudotox.|||participants|||Number
2595056|NCT02227108|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities|Participants were evaluated for ECG abnormalities.|Baseline up to 30 days after the last dose of study drug, up to 1 year|Safety population includes all participants who received any amount of moxetumomab pasudotox.|||participants|||Number
2595057|NCT02227108|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAE)|Laboratory tests were grouped according to hematology, serum chemistry, and urinalysis. Laboratory abnormalities with toxicity grades according to NCI CTCAE Version 4.03 were derived according to laboratory values and reported as treatment-emergent adverse events.|Baseline up to 30 days after the last dose of study drug, up to 1 year|Safety population includes all participants who received any amount of moxetumomab pasudotox.|||participants|||Number
2595058|NCT02227108|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|Treatment-emergent adverse events (TEAEs), were defined as events present at baseline that worsened in intensity after administration of investigational product or events absent at baseline that emerged after administration of study drug.|Baseline up to 30 days after the last dose of study drug, up to 1 year|Safety population includes all participants who received any amount of moxetumomab pasudotox.|||participants|||Number
2595059|NCT02227108|Secondary|Overall Survival (OS)|OS was determined as the time from the start of treatment with moxetumomab pasudotox until death due to any cause. For participants who were alive at the end of the study or lost to follow-up, OS was censored on the last date when the participant was known be alive. Kaplan-Meier method was used for evaluation.|Baseline to end of study or last contact date, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||months||Full Range|Median
2595060|NCT02227108|Secondary|Progression-Free Survival (PFS)|PFS was measured from the start of treatment with moxetumomab pasudotox until the first documentation of disease progression or death due to any cause, whichever occurred first. Kaplan-Meier method was used for evaluation.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||months||Full Range|Median
2595061|NCT02227108|Secondary|Duration of Overall Response (DOR)|DOR was to be defined as the duration from the first documentation of overall response to the first documented disease progression. Kaplan-Meier method was used for evaluation.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||months||Full Range|Median
2595062|NCT02227108|Secondary|Duration of Complete Response (DOCR)|DOCR was defined as the duration from the first documentation of CRc to the first documented disease progression.The CRc is defined as achieving complete response (CR), or CR with incomplete count recovery [CRi]) in participants with relapsed or refractory B-cell ALL or B-cell lymphoblastic lymphoma. Kaplan-Meier method was used for evaluation.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|"Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment. Here, number of participants analysed, N included evaluable participants for this outcome measure."|||months|||Number
2595063|NCT02227108|Secondary|Percentage of Participants Who Were Neutropenic at Study Entry and Who Experienced Hematologic Activity (HA)|The percentage of participants who were neutropenic at study entry and experienced HA after treatment with moxetumomab pasudotox was evaluated. The Clopper Pearson (Exact) 95% CI was calculated.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||percentage of participants|||Number
2595076|NCT02226965|Secondary|Time to Response|The number of months from Cycle 1 Day 1 until the date of the first documented response|19 months|All enrolled population: All patients who passed the screening in the study|||months||95% Confidence Interval|Mean
2595064|NCT02227108|Secondary|Time to Transplant to Receive an Stem Cell Transplant (SCT) After Treatment With Moxetumomab Pasudotox|The time to SCT was defined as the duration from the start of treatment with moxetumomab pasudotox until the date when the subject became eligible for SCT. The time to SCT was to be summarized using the Kaplan-Meier method, and was only to be evaluated for the subgroup of subjects who became eligible for SCT after treatment with moxetumomab pasudotox.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy population included participants who received moxetumomab pasudotox, completed a baseline disease assessment and had at least one post-baseline assessment. Since study was terminated prematurely, no participant received SCT after treatment with moxetumomab pasudotox, hence data were not collected for this Outcome measure.||||||
2595065|NCT02227108|Secondary|Percentage of Participants Who Became Eligible to Receive an Stem Cell Transplant (SCT) After Treatment With Moxetumomab Pasudotox|The percentage of participants who became eligible for SCT after treatment with moxetumomab pasudotox were provided. The Clopper Pearson (Exact) 95% CI was calculated.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||percentage of participants|||Number
2595066|NCT02227108|Secondary|Bone Marrow Blast Percentage Change|Change in bone marrow blast percentage from baseline was evaluated. If the percentage (%) blasts (at least 200 cells counted) is less than (<) 5%, it is considered as M1, 5 to 25% considered as M2, greater than (>) 25% considered as M3. Stages with the higher blasts relate to worse outcomes.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|"The intent to treat (ITT) population included all participants who entered the study. Here, number of participants analysed, N included evaluable participants for this outcome measure."|||percentage of participants|||Number
2595067|NCT02227108|Secondary|Best Overall Response (BOR)|The best overall response was calculated, based upon the disease assessments recorded during the study visits, and summarized with the number and percentage of participants for the following categories: CRc, PR, HA, SD, PD, and not evaluable. Overall best response is the best response observed for a participant during the study based on International Working Group (IWG) Response Criteria for malignant lymphoma. Complete response (CR) as per IWG is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. PR is a minimum of 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses and no increase in the size of other nodes and in size of liver or spleen. Stable disease (SD) is when a participant fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||percentage of participants|||Number
2595068|NCT02227108|Secondary|Time to Overall Response|Time to overall response was evaluated using the Kaplan-Meier method.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||months||95% Confidence Interval|Median
2595069|NCT02227108|Secondary|Overall Response Rate (ORR)|The ORR, defined as the percentage of participants with CRc or partial response (PR), was estimated; the Clopper Pearson (Exact) 95% CI was calculated. The CRc is defined as complete response (CR), or complete response with incomplete count recovery (CRi). Complete response (CR) as per International Working Group (IWG) is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Morphologic CR with incomplete blood count recovery (CRi) is defined as the above CR criteria without specified blood counts.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2595070|NCT02227108|Secondary|Percentage of Participants With Minimal Residual Disease (MRD)-Negative CRc Rate|The MRD-negative CRc rate was defined as the percentage of participants who achieved CRc and became MRD-negative as determined by flow cytometry performed by a central analysis laboratory. The CRc is defined as complete response (CR), or complete response with incomplete count recovery (CRi). Complete response (CR) as per International Working Group (IWG) is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Morphologic CR with incomplete blood count recovery (CRi) is defined as the above CR criteria without specified blood counts.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||percentage of participants|||Number
2595071|NCT02227108|Primary|Percentage of Participants With Composite Complete Response (CRc)|The CRc is defined as achieving complete response (CR), or CR with incomplete count recovery [CRi]) in participants with relapsed or refractory B-cell ALL or B-cell lymphoblastic lymphoma. Complete response (CR) as per International Working Group (IWG) is complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Morphologic CR with incomplete blood count recovery (CRi) is defined as the above CR criteria without specified blood counts. The efficacy assessments were evaluated as per investigator assessment.|Prior to Cycle 1, and prior to every cycle, at the end of treatment, at post-treatment follow-up visits, and at the end of the study, up to 1 year|Efficacy evaluable population included all participants who received any amount of moxetumomab pasudotox and completed a baseline disease assessment and had at least one post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2608982|NCT02071290|Primary|Plasma Fibrinogen|Change in plasma fibrinogen levels over 24 hours from Admission|0 (Admission), 1, 3, 24 hours||||g/mL||Inter-Quartile Range|Median
2595078|NCT02226965|Primary|Overall Response Rate|The proportion of patients with complete response (CR/complete metabolic response [CMR]) or partial response (PR/partial metabolic response [PMR]) according to the revised 2014 International Working Group (IWG) criteria for lymphoma (Cheson 2014)|19 months|All enrolled population: All patients who passed the screening in the study|||percentage of participants||95% Confidence Interval|Number
2595079|NCT02226653|Secondary|PK: Cmax of Evacetrapib (Fasted and Fed)||Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5|All randomized participants who completed and had evaluable Cmax Fasted and Fed State data for Periods 2,4, and 5.|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2595080|NCT02226653|Secondary|PK: AUC(0-∞)of Evacetrapib (Fasted and Fed)||Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5|All randomized participants who completed and had evaluable AUC(0-∞) Fasted and Fed State data for Periods 2,4, and 5.|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
2595081|NCT02226653|Secondary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib (Fasted and Fed)||Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5|All randomized participants who completed and had evaluable Tmax Fasted and Fed State data for Periods 2, 4, and 5.|||hour (h)||Full Range|Median
2595082|NCT02226653|Primary|PK: Maximum Concentration (Cmax) of Evacetrapib (Fasted)||Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4|All randomized participants who completed and had evaluable Cmax bioequivalence fasted state data for Periods 1,2,3 and 4.|||nanogram/milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
2595083|NCT02226653|Primary|Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (Fasted)||Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4|All randomized participants who completed and had evaluable AUC(0-∞) bioequivalence fasted state data for Periods 1,2,3 and 4.|||nanogram·hour/milliliter (ng·h/mL)||Geometric Coefficient of Variation|Geometric Mean
2595084|NCT02226562|Secondary|Mean Change From Baseline in VRS at Week 4|Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.|Baseline to 4 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.|||Score on scale||Standard Deviation|Mean
2595085|NCT02226562|Secondary|Mean Change From Baseline in Visual Rating Scale (VRS) at Week 8|Participants rated the intensity of their response to an evaporative air stimulus using a 10 point VRS scale with 1 indicating 'no pain' and 10 indicating 'Intense pain'. A reduction in the score is indicative of an improvement in sensitivity.|Baseline to 8 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.|||Score on scale||Standard Deviation|Mean
2595086|NCT02226562|Secondary|Mean Change From Baseline in Tactile Threshold at Week 4|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline to 4 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.|||Gram (g)||Standard Deviation|Mean
2595087|NCT02226562|Secondary|Mean Change From Baseline in Tactile Threshold at Week 8|The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline to 8 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.|||Gram(g)||Standard Deviation|Mean
2595088|NCT02226562|Secondary|Mean Change From Baseline in Schiff Sensitivity Score at Week 4|The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity.|Baseline to 4 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.|||Scores on scale||Standard Deviation|Mean
2595110|NCT02226198|Secondary|Trough Concentrations|Pharmacokinetic profile in terms of trough concentrations. Cross-over phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the cross-over phase. Maintenance phase results based on measurements taken after 6 weeks active treatment (rosuvastatin) in the maintenance phase.|Samples taken 24 hours post-dose at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18)||||ng/mL||Standard Deviation|Mean
2608983|NCT02071290|Primary|Plasma Protein C|Change in plasma Protein C levels over 24 hours from Admission|0 (Admission), 1, 3, 24 hours||||U/mL||Inter-Quartile Range|Median
2595089|NCT02226562|Primary|Mean Change From Baseline in Schiff Sensitivity Score at Week 8|The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity.|Baseline to 8 week|The primary population for efficacy assessment was intent-to-treat (ITT) population.The ITT population comprised of participants, who were randomized, received at least one dose of study treatment and provided at least one post-baseline assessment of efficacy.|||Score on scale||Standard Error|Least Squares Mean
2595090|NCT02226549|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||percentage of participants|||Number
2595091|NCT02226549|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 8 weeks|Safety Analysis Set: participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2595092|NCT02226549|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2595093|NCT02226198|Secondary|Abnormal Vital Signs|Safety and tolerability will be described in terms of abnormal vital signs|From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)||||participants|||Number
2595094|NCT02226198|Secondary|Physical Exam Abnormalitites|Safety and tolerability will be described in terms of abnormal physical examinations. Only parameters for which abnormalities were found are reported.|Screening, Week 0, week 6, week 12 and week 18, week 24||||participants|||Number
2595095|NCT02226198|Secondary|ECG Abnormalities|Safety and tolerability will be described in terms of abnormal electro cardio gram (ECG)|Week 0||||participants|||Number
2595096|NCT02226198|Secondary|Urinalysis Abnormalitites|Safety and tolerability will be described in terms of abnormal urine laboratory values|Week 0, week 6, week 12 and week 18||||participants|||Number
2595097|NCT02226198|Secondary|ApoB/ApoA|Efficacy in terms of apolipoprotein B (ApoB) / apolipoprotein A (ApoA)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||ratio||Standard Deviation|Mean
2595098|NCT02226198|Secondary|Non-HDL C/HDL C|Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C) / HDL C|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||ratio||Standard Deviation|Mean
2595099|NCT02226198|Secondary|TC/HDL C|Efficacy in terms of total cholesterol (TC) / high density lipoprotein cholesterol (HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||ratio||Standard Deviation|Mean
2595100|NCT02226198|Secondary|LDL C/HDL C|Efficacy in terms of low density lipoprotein cholesterol (LDL C) / high density lipoprotein cholesterol (HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||ratio||Standard Deviation|Mean
2595101|NCT02226198|Secondary|TG (mmol/L)|Efficacy in terms of triglycerides (TG)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||mmol/L||Standard Deviation|Mean
2595102|NCT02226198|Secondary|TG (mg/dL)|Efficacy in terms of triglycerides (TG)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||mg/dL||Standard Deviation|Mean
2595103|NCT02226198|Secondary|Tanner Stage|"Stages for fem (Pubic hair, Breasts):~(Preadol,Preadol)~(Sparse, lightly pigmented, medial border of labia,Breast and papilla elevated as small mound; areolar diam incr)~(Darker, beginning to curl, incr amount, Breast and areola enlarged, no contour separation)~(Course, curly, abundant but less amount in adult,Areola and papilla form secondary mound)~(Adult fem triangle, spread to medial surface of thighs,Mature, nipple projects, areola part of general breast contour) For males (Pubic hair, Penis, Testes)~1=(None,Preadol,Preadol) 2=(Scanty, long, light pigm,Slight enl,Enl scrotum, pink texture alt) 3=(Darker, starts to curl, small amount,Longer,Larger) 4=(Resembles adult type, but less in quant; course, curly,Larger; glans and breadth increased in size,Larger, scrotum dark) 5=(Adult distr, spread to medial thighs,Adult size,Adult size). Progr at a normal rate is preferred. Regr is not preferred."|Week 0 (start of cross-over)||||stage||Standard Deviation|Mean
2595104|NCT02226198|Secondary|Weight|Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.|Week 0 (start of cross-over), weeks 6, week 12 and week 18||||kg||Standard Deviation|Mean
2595105|NCT02226198|Secondary|Height Z-score|Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.|Week 0 (start of cross-over), weeks 6, week 12 and week 18||||ratio||Standard Deviation|Mean
2595106|NCT02226198|Secondary|Height|Safety and tolerability will be described in terms of growth, including height (linear growth [cm and standard deviation (SD) score]), and weight.|Week 0 (start of cross-over), weeks 6, week 12 and week 18||||cm||Standard Deviation|Mean
2595107|NCT02226198|Secondary|Abnormal Serum Levels|Safety and tolerability will be described in terms of abnormal serum laboratory values. The reported parameters are not the only ones measured, but rather those for which abnormailities were found|From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)||||participants|||Number
2595108|NCT02226198|Secondary|AE's Leading to Discontinuation|Safety and tolerability will be described in terms of rate of discontinuations due to adverse events|From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)||||adverse events|||Number
2595109|NCT02226198|Secondary|Adverse Events|Safety and tolerability will be described in terms of frequency and severity of adverse events|From screening (5-6weeks before dose) up to the last visit Day 168 (approximately 30 weeks after screening)||||adverse events|||Number
2595111|NCT02226198|Secondary|LDL-C From End of Placebo (mmol/L)|Change in low density lipoprotein cholesterol (LDL C) from end of placebo period to 6, 12, and 18 weeks of therapy with rosuvastatin 20 mg|Samples taken at Day 42 (week 6), Day 84 (week 12), Day 126 (week 18) and Day 168 (week 24)||||mmol/L||Standard Deviation|Mean
2595114|NCT02226198|Secondary|LDL-C, Not on Apheresis (mg/dL)|Efficacy in terms of low density lipoprotein cholesterol (LDL C) following 6 weeks rosuvastatin 20 mg or placebo treatment in patients not treated with Apheresis|Samples taken at Day 42 (week 6) and Day 84 (week 12)|Patients not treated with apheresis|||mg/dL||Standard Deviation|Mean
2595115|NCT02226198|Secondary|HDL-C (mmol/L)|Efficacy in terms of high density lipoprotein cholesterol (HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||mmol/L||Standard Deviation|Mean
2595116|NCT02226198|Secondary|HDL-C (mg/dL)|Efficacy in terms of high density lipoprotein cholesterol (HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||mg/dL||Standard Deviation|Mean
2595117|NCT02226198|Secondary|ApoB (g/L)|Efficacy in terms of apolipoprotein B (ApoB)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||g/L||Standard Deviation|Mean
2595118|NCT02226198|Secondary|ApoB (mg/dL)|Efficacy in terms of apolipoprotein B (ApoB)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||mg/dL||Standard Deviation|Mean
2595119|NCT02226198|Secondary|Non-HDL C (mmol/L)|Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||mmol/L||Standard Deviation|Mean
2595120|NCT02226198|Secondary|Non-HDL C (mg/dL)|Efficacy in terms of non-high density lipoprotein cholesterol (non-HDL C)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||mg/dL||Standard Deviation|Mean
2595121|NCT02226198|Secondary|TC (mmol/L)|Efficacy in terms of total cholesterol (TC)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||mmol/L||Standard Deviation|Mean
2595122|NCT02226198|Secondary|TC (mg/dL)|Efficacy in terms of total cholesterol (TC)|Samples taken at Day 42 (week 6) and Day 84 (week 12)||||mg/dL||Standard Deviation|Mean
2595123|NCT02226198|Primary|LDL-Cholesterol (mmol/L)|Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment|Samples taken on Day 42 (week 6) and on day 84 (week 12)|6-17 years HoFH|||mmol/L||Standard Deviation|Mean
2595124|NCT02226198|Primary|LDL-Cholesterol (mg/dL)|Change in low density lipoprotein cholesterol (LDL C) following 6 weeks of rosuvastatin 20 mg compared to 6 weeks of placebo treatment|Samples taken on Day 42 (week 6) and on day 84 (week 12)|6-17 years HoFH|||mg/dL||Standard Deviation|Mean
2595125|NCT02226172|Secondary|Number of Participants With Laboratory Test Abnormalities By Maximum Severity: National Cancer Institute Common Terminology Criteria for Adverse Event (Version 4.0) Grade 3 and Above Chemistry Test Abnormalities: Randomized Cohort|ALT/AST g1:>ULN 3*ULN, g2:>3-5*ULN, g3:>5 20*ULN, g4:>20*ULN); Alkaline Phosphatase (g1:>ULN 2.5*ULN, g2:>2.5-5*ULN, g3:>5 20*ULN, g4:>20*ULN);Creatinine (g1:>ULN-1.5*ULN, g2:>1.5-3*ULN, g3:>3 6*ULN, g4:>6*ULN);hyperglycemia (g1:>ULN-160,g2:>160 250, g3:>250 500,g4:>500mg/dL); bilirubin(total) (g1:>ULN-1.5*ULN, g2:>1.5-3*ULN, g3:>3 10*ULN,g4:>10*ULN); hypoglycaemia (g1:<LLN-55, g2:<55-40, g3:<40 30, g4:<30mg/dL); hyperkalemia (g1:>ULN-5.5,g2:>5.5-6, g3:>6 7,g4:>7mmol/L); hypokalemia (g1:<LLN-3,g2:<LLN-3,g3:<3 2.5, g4:<2.5mmol/L); hypermagnesemia (g1:>ULN-3,g3:>3 8,g4:>8mg/dL); hypocalcemia (g1:<LLN-8,g2:<8-7, g3:<7-6, g4:<6mg/dL); hypercalcemia (g1:>ULN-11.5,g2:>11.5-12.5, g3:>12.5-13.5, g4:>13.5mg/dL);hypomagnesemia (g1:<LLN-1.2,g2:<1.2-0.9, g3:<0.9-0.7,g4:<0.7mg/dL); hyponatremia (g1:<LLN-130,g3:<130-120, g4:<120mmol/L);hypoalbuminemia (g1:<LLN-3,g2:<3-2, g3:<2, g4:lifethreatening);hypophosphatemia (g1:<LLN-2.5,g2:<2.5-2,g3:<2-1,g4:<1mg/dL).|Baseline up to Week 131|The double blind, randomized, placebo controlled phase of the study was not enrolled as the study was terminated early so, no data were collected to assess this outcome measure.||||||
2595126|NCT02226172|Secondary|Number of Participants With Laboratory Test Abnormalities By Maximum Severity: National Cancer Institute Common Terminology Criteria for Adverse Event (Version 4.0) Grade 3 and Above Hematological Test Abnormalities: Randomized Cohort|Anemia g1:< LLN to 10 g/dL, g2:<10 to 8g/dL, g3:<8g/dL, g4:lifethreatening); platelet (g1:<LLN to 75*10^3/mm^3, g2:<75*10^3/mm^3 to 50*10^3/mm^3, g3:<50*10^3/mm^3 to 25*10^3/mm^3, g4:<25*10^3/mm^3); lymphopenia (g1:<LLN to 8*10^2/mm^3, g2:<8*10^2 to 5*10^2/mm^3, g3:<5*10^2 to 2*10^2/mm^3, g4:<2*10^2/mm^3);neutrophil (absolute) (g1:<LLN to 15*10^2/mm^3, g2:<15*10^2 to 10*10^2/mm^3, g3:<10*10^2 to 5*10^2/mm^3, g4:<5*10^2/mm^3); white blood cell count (g1:<LLN to 3*10^3/mm^3, g2:<3*10^3 to 2*10^3/mm^3, g3: <2*10^3 to 1*10^3/mm^3, g4:<1*10^3/mm^3); hemoglobin(g1:increase in hemoglobin level>0 to 2 g/dL above ULN or above baseline if baseline is above ULN, g2: increase in hemoglobin level>2 to 4g/dL above ULN or above baseline if baseline is above ULN, g3:increase in hemoglobin level>4 g/dL above ULN or above baseline if baseline is above ULN).|Baseline up to Week 131|The double blind, randomized, placebo controlled phase of the study was not enrolled as the study was terminated early so, no data were collected to assess this outcome measure.||||||
2595127|NCT02226172|Primary|Number of Participants With Laboratory Test Abnormalities According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 Grade 3 and Above Chemistry Test Abnormalities: Lead-in Cohort|ALT/AST g1:>ULN 3*ULN, g2:>3-5*ULN, g3:>5 20*ULN, g4:>20*ULN); Alkaline Phosphatase (g1:>ULN 2.5*ULN,g2:>2.5-5*ULN, g3:>5 20*ULN, g4:>20*ULN); Creatinine (g1:>ULN-1.5*ULN,g2:>1.5-3*ULN, g3:>3 6*ULN, g4:>6*ULN);hyperglycemia (g1:>ULN-160,g2:>160 250, g3:>250 500, g4:>500mg/dL);bilirubin(total) (g1:>ULN-1.5*ULN, g2:>1.5-3*ULN, g3:>3 10*ULN,g4:>10*ULN);hypoglycaemia (g1:<LLN-55,g2:<55-40, g3:<40 30,g4:<30mg/dL); hyperkalemia (g1:>ULN-5.5,g2:>5.5-6, g3:>6 7,g4:>7mmol/L);hypokalemia (g1:<LLN-3,g2:<LLN-3, g3:<3 2.5, g4:<2.5mmol/L);hypermagnesemia (g1:>ULN-3,g3:>3 8, g4:>8mg/dL);hypocalcemia (g1:<LLN-8,g2:<8-7, g3:<7-6, g4:<6mg/dL); hypercalcemia (g1:>ULN-11.5,g2:>11.5-12.5, g3:>12.5-13.5, g4:>13.5mg/dL); hypomagnesemia (g1:<LLN-1.2,g2:<1.2-0.9,g3:<0.9-0.7, g4:<0.7mg/dL); hyponatremia (g1:<LLN-130,g3:<130-120, g4:<120mmol/L);hypoalbuminemia (g1:<LLN-3,g2:<3 2,g3:<2, g4:lifethreatening);hypophosphatemia (g1:<LLN-2.5,g2:<2.5-2, g3:<2-1, g4:<1mg/dL).|Baseline up to Week 131|All participants treated in the lead-in portion of the study.|||Participants|||Count of Participants
2595141|NCT02226172|Secondary|Area Under the Glasdegib Plasma Concentration Versus Time Profile at the End of a Dosing Interval (AUCtau) in the Lead-in Cohort|AUCtau was the area under the glasdegib plasma concentration-time profile from time zero to the end of the dosing interval (24 hours) estimated by non-compartmental PK analysis using the linear/log trapezoidal method.|Cycle 1, Day 15|PK Parameter Analysis Population|||ng·hr/mL||Geometric Coefficient of Variation|Geometric Mean
2595211|NCT02224820|Primary|Efficacy|Efficacy was defined as the IdeS dosing scheme in the majority of the patients resulting in human leucocyte antigen (HLA) antibody levels which are acceptable for transplantation, measured as mean fluorescent intensity (MFI) of less than 1100, within 24 hours from dosing. MFI was determined by single antigen bead (SAB) assay and detection of complement fixating ability (CIq Screen) in serum.|24 hours||||MFI||Inter-Quartile Range|Mean
2595128|NCT02226172|Secondary|Number of Participants With Laboratory Abnormalities: Randomized Cohort|Abnormality: hematology: hemoglobin less than (<)0.8*lower limit of normal(LLN), platelets <0.5*LLN >1.75*upper limit of normal(ULN), white blood cell count(WBC) <0.6* LLN greater than (>)1.5* ULN,lymphocytes, total neutrophils<0.8* LLN >1.2* ULN, band Cells, basophils, eosinophils, monocytes >1.2*ULN, blast cells >1.0*ULN. Coagulation: activated partial thromboplastin time, prothrombin international ratio >1.1* ULN. Liver function: bilirubin >1.5*ULN, AST, ALT,lactate dehydrogenase,alkaline phosphatase >3.0*ULN, protein,albumin <0.8* LLN >1.2* ULN. Renal:blood urea nitrogen,creatinine >1.3* ULN,uric acid >1.2* ULN.Electrolytes: sodium <0.95*LLN >1.05*ULN, potassium, chloride, calcium, magnesium <0.9* LLN >1.1*ULN,phosphate <0.8* LLN >1.2* ULN.Chemistry: glucose <0.6*LLN >1.5*ULN,creatine kinase >2.0*ULN, amylase,lipase >1.5*ULN.Urinalysis: protein, blood >1.0*ULN,red blood cells,WBC >=20,epithelial cells >=6,casts,granular casts,hyaline >1,cellular casts,crystals>=1,bacteria >20.|Baseline up to Week 131|The double blind, randomized, placebo controlled phase of the study was not enrolled as the study was terminated early so, no data were collected to assess this outcome measure.||||||
2595129|NCT02226172|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) According to Maximum Severity: Randomized Cohort|AE was untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE was AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AE were assessed according to maximum severity grading based on NCI CTCAE Version 4.03.Grade 1=mild; Grade 2=moderate; within normal limits. Grade 3=severe or medically significant but not immediately life-threatening; Grade 4=life-threatening or disabling; urgent intervention indicated; Grade 5=death.|Baseline up to Week 131|The double blind, randomized, placebo controlled phase of the study was not enrolled as the study was terminated early so, no data were collected to assess this outcome measure.||||||
2595130|NCT02226172|Secondary|Number of Participants With Treatment Emergent Treatment -Related Adverse Events (AEs) and Serious Adverse Events (SAEs): Randomized Cohort|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. Relatedness to study drug was assessed by the investigator.|Baseline up to Week 131|The double blind, randomized, placebo controlled phase of the study was not enrolled as the study was terminated early so, no data were collected to assess this outcome measure.||||||
2595131|NCT02226172|Secondary|Number of Participants With Treatment -Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Randomized Cohort|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state.|Baseline up to Week 131|The double blind, randomized, placebo controlled phase of the study was not enrolled as the study was terminated early so, no data were collected to assess this outcome measure.||||||
2595132|NCT02226172|Secondary|Psychometric Validation of the MPN-SAD in the Randomised Cohort|The double blind, randomized, placebo controlled phase of the study was not enrolled after the study was terminated early so no data were collected to assess this endpoint.|Baseline to end of treatment|FAS||||||
2595133|NCT02226172|Secondary|Glasdegib PK Parameters in the Randomized Cohort|The double blind, randomized, placebo controlled phase of the study was not enrolled after the study was terminated early so no data were collected to assess this endpoint.|Cycle 1, Day 15|PK Parameter Analysis Population||||||
2595134|NCT02226172|Secondary|Kaplan-Meier Estimate of Overall Survival in the Randomized Cohort|The double blind, randomized, placebo controlled phase of the study was not enrolled after the study was terminated early so no data were collected to assess this endpoint.|Baseline to end of treatment|FAS||||||
2595135|NCT02226172|Secondary|Median Duration of SVR in the Randomized Cohort|The double blind, randomized, placebo controlled phase of the study was not enrolled after the study was terminated early so no data were collected to assess this endpoint.|Baseline to end of treatment|FAS||||||
2595136|NCT02226172|Secondary|Participant Reported Outcomes of Health Related Quality of Life and Health Status in the Randomised Cohort|The double blind, randomized, placebo controlled phase of the study was not enrolled after the study was terminated early so no data were collected to assess this endpoint.|Baseline to end of treatment|FAS||||||
2595137|NCT02226172|Secondary|Percentage of Participants Achieving Anemia Response (Transfusion Dependent Versus Independent) in the Randomized Cohort|The double blind, randomized, placebo controlled phase of the study was not enrolled after the study was terminated early so no data were collected to assess this endpoint.|Baseline to end of treatment|FAS||||||
2595138|NCT02226172|Secondary|Monthly Mean Change From Baseline in Overall TSS in the Randomized Cohort|The double blind, randomized, placebo controlled phase of the study was not enrolled after the study was terminated early so no data were collected to assess this endpoint.|Weeks 12, 24, 36 and 48|FAS||||||
2595139|NCT02226172|Secondary|Percentage of Participants Achieving SVR ≥50% as Measured by MRI/CT Scan at Week 24 in the Randomized Cohort|The double blind, randomized, placebo controlled phase of the study was not enrolled after the study was terminated early so no data were collected to assess this endpoint.|Week 24|FAS||||||
2595140|NCT02226172|Secondary|Time to Reach Cmax (Tmax) in the Lead-in Cohort|Tmax was the time of the first occurrence of Cmax observed directly from the plasma concentration data.|Cycle 1, Day 15|PK Parameter Analysis Population|||Hours||Full Range|Median
2608984|NCT02071290|Primary|Plasma D-Dimer|Change in plasma D-Dimer levels over 24 hours from Admission|0 (Admission), 1, 3, 24 hours||||ug/mL||Inter-Quartile Range|Median
2595142|NCT02226172|Secondary|Maximum Observed Glasdegib Plasma Concentration (Cmax), Minimum Glasdegib Plasma Concentration Observed Prior to the Next Dose (Cmin), and Average Observed Glasdegib Plasma Concentration (Cavg) in the Lead-in Cohort|Cmax was the highest plasma concentration of glasdegib observed directly from the plasma concentration data. Cmin was the lowest plasma concentration of glasdegib observed directly from the plasma concentration data. Cavg was the average concentration at steady state estimated using non-compartmental pharmacokinetic (PK) analysis.|Cycle 1, Day 15|PK Parameter Analysis Population - included all enrolled participants treated who had at least 1 of the PK parameters of interest and were dose compliant (at steady state for glasdegib ).|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2595143|NCT02226172|Secondary|Percentage of Participants Achieving Anemia Response (Transfusion Dependent Versus Independent) in the Lead-in Cohort|Anemia response was defined as transfusion-independent participants with a ≥20 gram per liter (g/L) increase in hemoglobin (Hb) level where baseline Hb level was <100 g/L, or baseline transfusion-dependent patients becoming transfusion-independent post-baseline. Transfusion dependency before the start of study treatment was defined as transfusions of ≥6 units of packed red blood cells in the 12 weeks prior to start of study treatment, for a final pre-treatment Hb of <85 g/L. In addition, the most recent transfusion episode must have occurred in the 28 days prior to study enrollment. Response in transfusion-dependent patients required absence of any packed red blood cell transfusions during any consecutive rolling 12-week interval during the treatment phase, capped by a Hb level of ≥85 g/L.|Baseline to end of treatment|Lead-in Analysis Set|||Percentage of participants|||Number
2595144|NCT02226172|Secondary|Monthly Mean Change From Baseline in Overall Total Symptom Score (TSS) in the Lead-in Cohort|The MPN-SAD assessed the impact of 9 myelofibrosis symptoms, at their worst, over the past 7 days and over the past 24 hours on a scale of 0 (absent) to 10 (worst imaginable). The 9 symptoms are early satiety, abdominal discomfort, inactivity, night sweats, pruritus, bone pain, pain below the ribs on the left-hand side, fatigue and shortness of breath. The TSS is the sum of the individual scores, excluding inactivity and shortness of breath. The TSS at Week 24 is the average of the daily total scores from the last 28 days of symptom scores immediately prior to Week 24. A higher score indicates worse symptoms.|Weeks 12, 24, 36 and 48|Lead-in Analysis Set|||Score on a scale||Standard Deviation|Mean
2595145|NCT02226172|Secondary|Percentage of Participants Achieving ≥50% Reduction From Baseline in Total Symptom Score (TSS) as Measured by the Myeloproliferative Neoplasm-Symptom Assessment Diary (MPN-SAD) at Week 24 in the Lead-in Cohort|The MPN-SAD assessed the impact of 9 myelofibrosis symptoms, at their worst, over the past 7 days and over the past 24 hours on a scale of 0 (absent) to 10 (worst imaginable). The 9 symptoms are early satiety, abdominal discomfort, inactivity, night sweats, pruritus, bone pain, pain below the ribs on the left-hand side, fatigue and shortness of breath. The TSS is the sum of the individual scores, excluding inactivity and shortness of breath. The TSS at Week 24 is the average of the daily total scores from the last 28 days of symptom scores immediately prior to Week 24. A higher score indicates worse symptoms.|Week 24|Lead-in Analysis Set|||Percentage of participants|||Number
2595146|NCT02226172|Secondary|Percentage of Participants Achieving SVR ≥35% as Measured by Magnetic Resonance Imaging/Computed Tomography Scan at Week 24 in the Lead-in Cohort|MRI (CT scan may have been permitted if MRI was contraindicated) of the spleen and the liver was performed at baseline, then every 12 weeks while the participant was on treatment. The same method of assessment used at baseline was used for the duration of the trial to ensure consistency. Spleen volume was assessed by a central, independent blinded reader.|Week 24|Lead-in Analysis Set - included all participants treated in the lead-in portion of the study. Only participants who remained on treatment at Week 24 underwent MRI/CT scan.|||Percentage of participants|||Number
2595147|NCT02226172|Primary|Number of Participants With Laboratory Test Abnormalities According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 Grade 3 and Above Hematological Test Abnormalities: Lead-in Cohort|Anemia (grade [g]1:< LLN to 10 gram per deciliter [g/dL],g2:<10 to 8g/dL,g3:<8g/dL, g4:lifethreatening); platelet (g1:<LLN to 75*10^3/millimeter[mm]^3, g2:<75*10^3/mm^3 to 50*10^3/mm^3, g3:<50*10^3/mm^3 to 25*10^3/mm^3, g4:<25*10^3/mm^3); lymphopenia (g1:<LLN to 8*10^2/mm^3, g2:<8*10^2 to 5*10^2/mm^3, g3:<5*10^2 to 2*10^2/mm^3, g4:<2*10^2/mm^3);neutrophil (Absolute) (g1:<LLN to 15*10^2/mm^3, g2:<15*10^2 to 10*10^2/mm^3, g3:<10*10^2 to 5*10^2/mm^3, g4:<5*10^2/mm^3); white blood cell count(g1:<LLN to 3*10^3/mm^3, g2:<3*10^3 to 2*10^3/mm^3, g3:<2*10^3 to 1*10^3/mm^3, g4:<1*10^3/mm^3); hemoglobin (g1:increase in hemoglobin level >0 to 2 g/dL above ULN or above baseline if baseline is above ULN, g2:increase in hemoglobin level>2 to 4g/dL above ULN or above baseline if baseline is above ULN,g3: increase in hemoglobin level>4 g/dL above ULN or above baseline if baseline is above ULN).|Baseline up to Week 131|All participants treated in the lead-in portion of the study.|||Participants|||Count of Participants
2595148|NCT02226172|Primary|Number of Participants With Laboratory Abnormalities: Lead-in Cohort|Abnormality: hematology: hemoglobin less than (<)0.8*lower limit of normal(LLN), platelets <0.5*LLN greater than (>)1.75*upper limit of normal(ULN), white blood cell count(WBC) <0.6* LLN >1.5* ULN,lymphocytes, total neutrophils<0.8* LLN >1.2* ULN, band Cells, basophils, eosinophils, monocytes >1.2*ULN, blast cells >1.0*ULN. Coagulation: activated partial thromboplastin time, prothrombin international ratio >1.1* ULN. Liver function: bilirubin >1.5*ULN, AST, ALT,lactate dehydrogenase,alkaline phosphatase >3.0*ULN, protein,albumin <0.8* LLN >1.2* ULN. Renal:blood urea nitrogen,creatinine >1.3*ULN,uric acid >1.2*ULN.Electrolytes: sodium <0.95*LLN >1.05*ULN, potassium, chloride, calcium, magnesium <0.9* LLN >1.1*ULN,phosphate <0.8* LLN >1.2* ULN.Chemistry: glucose <0.6*LLN >1.5*ULN,creatine kinase >2.0*ULN, amylase,lipase >1.5*ULN.Urinalysis: protein, blood >1.0*ULN,red blood cells,WBC >=20,epithelial cells >=6,casts,granular casts,hyaline >1,cellular casts,crystals>=1,bacteria >20.|Baseline up to Week 131|All participants treated in the lead-in portion of the study.|||Participants|||Count of Participants
2595157|NCT02226003|Secondary|Percentage of Participants With HbA1C <7% (<53 mmol/Mol) at Week 26|HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1c represents the percentage of glycated hemoglobin.|Week 26|FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline in the Week 26 HbA1C endpoint.|||Percentage of participants|||Number
2595212|NCT02224755|Secondary|Adverse Event Rates|Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol|Two years post-implant||||events per patient year|||Number
2595149|NCT02226172|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03: Lead-in Cohort|AE was untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE was AE resulting in any outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability; congenital anomaly.Treatment-emergent were events between first dose of study drug and up to 28 days after last dose of study drug (up to Week 131) that were absent before treatment or that worsened relative to pretreatment state.AE were assessed according to maximum severity grading based on NCI CTCAE Version 4.03.Grade 1=mild; Grade 2=moderate; within normal limits. Grade 3=severe or medically significant but not immediately life-threatening; Grade 4=life-threatening or disabling; urgent intervention indicated; Grade 5=death. Only categories with at least 1 participant with event were reported.|Baseline up to Week 131|All participants treated in the lead-in portion of the study.|||Participants|||Count of Participants
2595150|NCT02226172|Primary|Number of Participants With Treatment Emergent Treatment -Related Adverse Events (AEs) and Serious Adverse Events (SAEs): Lead-in Cohort|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose of study drug (up to Week 131) that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator. AEs included both serious and non-serious adverse event.|Baseline up to Week 131|All participants treated in the lead-in portion of the study.|||Participants|||Count of Participants
2595151|NCT02226172|Primary|Number of Participants With Treatment -Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Lead-in Cohort|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose of study drug (up to Week 131) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline up to Week 131|All participants treated in the lead-in portion of the study.|||Participants|||Count of Participants
2595152|NCT02226172|Primary|Percentage of Participants Achieving Spleen Volume Reduction (SVR) ≥35% as Measured by Magnetic Resonance Imaging (MRI)/Computed Tomography (CT) Scan at Week 24 in the Randomized Cohort|The double blind, randomized, placebo controlled phase of the study was not enrolled after the study was terminated early so no data were collected to assess this endpoint.|Week 24|FAS included all participants in the randomized Phase 2 component of the study who were randomized with study drug assignment designated according to initial randomization.||||||
2595153|NCT02226120|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths as a Measure of Safety and Tolerability of LCZ696|The primary assessments for safety were the reporting of angioedema, AEs suspected to be related to LCZ696, AEs leading to study drug discontinuation and serious adverse events (SAE) including death. The assessment of safety were based primarily on the frequency of adverse events of special interest, sitting systolic and diastolic blood pressure, heart rate, and serious adverse events suspected by the investigators to be related to LCZ696 for the Safety set. Only descriptive analysis done.|From first dose of study treatment to 30 days after last dose of study treatment, up to 30 months.|Safety Set (SAF), which consisted of all enrolled participants who received at least one dose of open-label study medication, was considered. Only descriptive analysis done.|||Participants|||Count of Participants
2595154|NCT02226003|Secondary|Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach|Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Baseline and Week 26|The FAS population included all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 sitting diastolic blood pressure endpoint.|||millimeters of mercury||95% Confidence Interval|Least Squares Mean
2595155|NCT02226003|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach|Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Baseline and Week 26|FAS population included all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 sitting systolic blood pressure endpoint.|||millimeters of mercury||95% Confidence Interval|Least Squares Mean
2595156|NCT02226003|Secondary|Change From Baseline in Body Weight at Week 26 - Full Analysis Set Excluding Rescue Approach|Body weight was measured using a standardized, digital scale at each of the pre-defined nominal time points. Weight was taken in duplicate throughout the trial at approximately the same time of day, after voiding (i.e., forced void) and while wearing only a gown and underwear. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Baseline and Week 26|FAS population is all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 body weight endpoint.|||Kilograms||95% Confidence Interval|Least Squares Mean
2595173|NCT02225860|Primary|Change in Mean Serum Copeptin From Baseline (a Reflection of Endogenous Vasopressin Production) at Week 2|The copeptin level will reflect the combined effect of low osmolar diet and adjusted water intake at week 2|Baseline to week 2||||pmole/L||Standard Deviation|Mean
2595158|NCT02226003|Secondary|Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 26 - Full Analysis Set Excluding Rescue Approach|Change from baseline at Week 26 is defined as 2-hour PMG at Week 26 minus 2-hour PMG at Week 0. Two-hour post-meal glucose was measured following a standard meal. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Baseline and Week 26|FAS population is all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 2-hour PMG endpoint.|||milligrams/deciliter||95% Confidence Interval|Least Squares Mean
2595159|NCT02226003|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Full Analysis Set Excluding Rescue Approach|Blood glucose was measured after a ≥10 hour fast. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at baseline). Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Baseline and Week 26|FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 FPG endpoint.|||milligrams/deciliter||95% Confidence Interval|Least Squares Mean
2595160|NCT02226003|Primary|Percentage of Participants Who Discontinued Study Medication Due to an AE - All Participants as Treated Excluding Rescue Approach|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Up to Week 26|ASaT population consisted of all randomized participants who received at least one dose of a study drug.|||Percentage of Participants|||Number
2595161|NCT02226003|Primary|Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants as Treated Excluding Rescue Approach|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Up to Week 28|All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one dose of a study drug.|||Percentage of Participants|||Number
2595162|NCT02226003|Primary|Change From Baseline in Hemoglobin A1C (HbA1C) at Week 26 - Full Analysis Set (FAS Population Excluding Rescue Approach|HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1C represents the percentage of glycated hemoglobin. A negative number indicates a reduction in HbA1C level. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.|Baseline and Week 26|FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 HbA1C endpoint.|||Percentage||95% Confidence Interval|Least Squares Mean
2595163|NCT02225925|Secondary|Prostate Specific Antigen (PSA) Outcomes|PSA biochemical failure-free survival at last follow-up visit|up to 5 years||||Participants|||Count of Participants
2595164|NCT02225925|Secondary|Quality of Life (QoL) Assessments|Change in Quality of Life measures based on International Prostate Symptom Score (range 0-35, higher score reflects lower quality of life), Sexual Health Inventory Score (1-25, lower score reflects lower quality of life), Epic-26 Bowel score (0-100, lower score reflects lower quality of life)|baseline, 30 days post-implant, semiannually post treatment until year 2 and then annually until year 5|Data was not collected to assess this outcome measure||||||
2595165|NCT02225925|Secondary|Dosimetric Accuracy Comparison Between Pre and Post Ultrasound (US) Implantation Prostate Edema||Treatment - 30 days|Data was not collected to assess this outcome measure||||||
2595166|NCT02225925|Secondary|Mean Difference in D90 Between Intra-operative RUF and Standard CT/MRI Based Dosimetry|Mean difference of D90 (% of prescribed dose) between intra-operative RUF and standard CT/MRI based dosimetry|Treatment - 30 days||||percentage of prescribed dose||95% Confidence Interval|Mean
2595167|NCT02225925|Secondary|Impact of RUF System on Dosimetric Outcomes of Seed Placement as Assessed by Number of Patients With Prostate V100 of 95% or Greater|Number of patients with prostate V100 (the percent of the postimplant MR/CT-based prostate volume that received at least 100% of dose) of 95% or greater|30 days post-treatment||||Participants|||Count of Participants
2595168|NCT02225925|Secondary|Number of Participants With Seed Reconstruction Utilizing RUF Versus CT / Magnetic Resonance Imaging (MRI) Reconstruction|Number of participants with seed reconstruction with RUF versus CT fused with MRI doses for Prostate D90 (dose received by 90% of prostate)|30 days post-treatment|Data was not collected to assess this outcome measure||||||
2595169|NCT02225925|Secondary|Seed Reconstruction From Intra-operative Fluoroscopy|Number of patients with all seeds reconstructed from fluoroscopy|up to 30 days post-treatment||||Participants|||Count of Participants
2595170|NCT02225925|Primary|Procedure Time|Additional procedure time with the registered ultrasound and fluoroscopy system (RUF) in the intra-operative setting for implantation procedure|at time of implantation procedure||||minutes||Full Range|Mean
2595171|NCT02225860|Secondary|Change in Mean Serum Copeptin Level From Baseline to Week 1|Mean serum copeptin level at week one which will reflect the effect of low osmolar diet alone.|baseline to week 1|At week 1, there was a nonsignificant (t-test) increase in plasma copeptin to 7.1 ±5.6 in the low osmolar diet group and to 6.1 ±5.5 in the control group. The change in mean plasma copeptin level between baseline and week1 was not statistically significant between groups.|||pmol/L||Standard Deviation|Mean
2595172|NCT02225860|Secondary|Change in Total Daily Urinary Solutes From Baseline to Week 2|"Total daily urinary solutes (this will serve as a surrogate for diet adherence and is known to be associated with lower vasopressin secretion).~Total daily solutes is the total amount of osmoles detected in 24 hours urine collection."|Baseline to week 2||||mOsm/Day||Standard Deviation|Mean
2595174|NCT02225743|Primary|Incidence of Hypothermia|The incidence of ever being hypothermic (temperature < 36.0 °C at one or more measurements) was the primary outcome. All temperatures were assessed with an Exergen temporal thermometer (precise to 0.1 °C). Each temporal measurement was taken and recorded three times for accuracy and the mean value utilized for data analysis at each time point. Temperatures were measured upon (1) leaving holding area; (2) operating room (OR) arrival; (3) after anesthetic induction; (4) upper body forced air warmer initiation (used for all patients); (5) incision; (6-8) every 30 minutes after incision; (9) leaving the OR; and (10) arrival to PACU. OR temperature and humidity were recorded throughout.|Starting with temperature measurement prior to leaving preoperative holding for OR and ending after temperature taken on arrival in recovery room|Ever hypothermic (temperature <36.0 degrees C) during the perioperative period|||Participants|||Count of Participants
2595175|NCT02225587|Secondary|Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 30|Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.|Week 30|All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.|||Titer||95% Confidence Interval|Geometric Mean
2595176|NCT02225587|Secondary|Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 26|Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.|Week 26|All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.|||Titer||95% Confidence Interval|Geometric Mean
2595177|NCT02225587|Secondary|Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F at Week 8|Vaccine-induced functional antibodies were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.|Week 8|All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.|||Titer||95% Confidence Interval|Geometric Mean
2595178|NCT02225587|Primary|Geometric Mean Titers to Pneumococcal Serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, at Week 12|Vaccine-induced functional antibodies to serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, which are contained in both Prevnar 13™ and PNEUMOVAX™ 23, were measured by the MOPA-4 assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.|Week 12|All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.|||Titer||95% Confidence Interval|Geometric Mean
2595179|NCT02225587|Primary|Geometric Mean Titers to Pneumococcal Serotypes 22F and 33F at Week 12|Vaccine-induced functional antibodies to serotypes 22F and 33F, which are unique to PNEUMOVAX™ 23, were measured by the multiplex opsonophagocytic activity 4 (MOPA-4) assay, which is based on the ability of antibody in the serum to initiate killing of bacterial pneumococci.|Week 12|All randomized participants who received at least 1 vaccination and provided serology data for the particular serotype tested; with appropriate day ranges for vaccinations and blood draws, and excludes participants with important deviations from the protocol that may substantially affect the results.|||Titer||95% Confidence Interval|Geometric Mean
2595180|NCT02225587|Primary|Percentage of Participants Who Discontinued Vaccination Due to an Adverse Event|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to 26 weeks|Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.|||Percentage of participants|||Number
2595181|NCT02225587|Primary|Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) or Vaccine-related Death|A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose. The investigator determined whether the SAE or death was related to vaccine treatment.|Up to 30 weeks|Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.|||Percentage of participants|||Number
2595182|NCT02225587|Primary|Percentage of Participants With a Serious Adverse Event (SAE)|A serious adverse event (SAE) is any adverse event occurring at any dose or during any use of Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is another important medical event; is a cancer; or is associated with an overdose.|Up to 30 weeks|Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.|||Percentage of participants|||Number
2595183|NCT02225587|Primary|Percentage of Participants With a Systemic Adverse Event|Systemic adverse events (AEs) include, but are not restricted to the following AE terms: muscle pain, joint pain, headache, and tiredness.|Up to 14 days after any vaccination (Up to 28 weeks)|Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.|||Percentage of participants|||Number
2595184|NCT02225587|Primary|Percentage of Participants With an Injection-site Adverse Event|An injection site adverse event (AE) includes the following AEs at the injection site: redness, swelling, and pain/tenderness.|Up to 14 days after any vaccination (Up to 28 weeks)|Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.|||Percentage of participants|||Number
2595185|NCT02225587|Primary|Percentage of Participants With an Adverse Event (AE)|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to 14 days after any vaccination (Up to 28 weeks)|Participants who received at least 1 dose of treatment and followed up for safety. Two participants from Group 1, and 1 participant from Group 2 were not analyzed due to lack of follow-up data. As the objective was to report the combined safety of the two vaccines given 8 or 26 weeks apart, results are presented for the sequence of vaccinations.|||Percentage of participants|||Number
2595186|NCT02225353|Secondary|Number of Adverse Events Related With the Use of Treatment|The number of adverse events reported were analyzed as being related with the treatment as well as for unexpectedness.|Up to 36 weeks of gestational age|Intention-to-treat (ITT)|||events|number of adverse events||Number
2595187|NCT02225353|Secondary|Acceptability and Tolerance of Use of the Cerclage Pessary|"A questionnaire was planned to be used to compare acceptability and tolerance in the insertion, during pregnancy and during the extraction of Cerclage Pessary.~Data from this questionnaire was not collected."|Up to 36 weeks of gestational age|No participants were analyzed||||||
2595188|NCT02225353|Secondary|Anatomical Feature: Position of the Uterine Cervix|During the pregnancy the position of the uterine cervix will be assessed. The rational being that premature birth is associated with uterine cervix positioning. The position of the cervix was determined using transvaginal ultrasound examination. In the change from baseline visit a positive value change indicated that the investigator believed that the position of the cervix changed in a positive manner to facilitate a term birth. The comparison between premature an normal birth initially planned by the protocol was not analyzed. The results reported are the degrees of the cervix position relative to the longitudinal axis of the uterus.|Up to 36 weeks of gestational age. Results are reported for all assessments from baseline through final visit, for a total of 8 visits, and for up to 36 weeks of gestational age.|Intention-to-treat (ITT).|||degrees||Standard Deviation|Mean
2595189|NCT02225353|Secondary|Anatomical Feature: Length of the Uterine Cervix|During the pregnancy the length of the uterine cervix will be assessed. The rational is that premature birth is associated with uterine cervix shortening. The length of the cervix was determined using ultrasound examination. A positive change from baseline indicates a positive development, i.e. less likely to result in a preterm birth. The comparison between premature an normal birth initially planned by the protocol was not analyzed.|Up to 36 weeks of gestational age. Results are reported for all assessments from baseline through final visit, for a total of 8 visits, and for up to 36 weeks of gestational age.|Intention-to-treat (ITT).|||millimeter||Standard Deviation|Mean
2595190|NCT02225353|Secondary|Number of Participants With Premature Rupture of Membranes|A participant with premature rupture of membrane typically recalls a sudden gush of fluid loss from the vagina, or steady loss of small amounts of fluid. Participants who reported vaginal discharge were examined by a physician.|Up to 36 weeks of gestational age|Intention-to-Treat Population|||Participants|||Count of Participants
2595191|NCT02225353|Primary|Number of Participants Not Giving Birth Before Week 32 and Week 34 of Gestation|"To assess the efficacy of Cerclage Pessaries containing 6.3 g and 7.7 g micronized progesterone for the prevention of preterm delivery, established through spontaneous parturition before gestation weeks 32 (31 weeks and 6 days) and 34 (33 weeks and 6 days), when the pessary is inserted between weeks 16 and 24 and removed at 36 weeks and 6 days in pregnant women at high risk of premature delivery.~For the purpose of this analysis, pregnancies were no longer considered as high risk for the event if delivery occurred at week 34 of gestation and beyond. Gestational age was determined by the last menstruation date and were confirmed by measurement of the craniocaudal length obtained in the first trimester ultrasound, or by measurement of the cephalic circumference in the second trimester ultrasound predominating the actual date of the last menstrual period.~The number of participants not giving birth before 32 weeks and 34 weeks are reported."|Up to 36 weeks of gestational age|271 participants comprised the Intention-to-treat analysis (ITT) population at baseline, 268 participants at gestation week 32, and 262 participants at gestation week 34.|||Participants|||Count of Participants
2595192|NCT02225132|Primary|Fetal Hemoglobin Level|Mean fetal hemoglobin calculated to indicate effectiveness of hydroxyurea dose|12 months||||Percentage||Standard Deviation|Mean
2595193|NCT02225132|Primary|Fetal Hemoglobin Level|Mean fetal hemoglobin calculated to indicate effectiveness of hydroxyurea dose|Baseline||||Percentage||Standard Deviation|Mean
2595207|NCT02224820|Secondary|Pharmacokinetics|IdeS T1/2 in alpha phase. One patient who interrupted dose was excluded.|Up to 21 days||||h||Inter-Quartile Range|Mean
2595208|NCT02224820|Secondary|Immunogenicity|Presence of Anti-Drug Antibodies formation in serum throughout a 64 day period|Up to 64 days||||participants|||Number
2595209|NCT02224820|Secondary|Pharmacodynamics|IgG cleavage and regeneration measured by ELISA|Up to day 64||||µg/mL||Standard Deviation|Mean
2595194|NCT02225106|Primary|Perceptual Organization and Processing Speed Index|"Relationship between tonic DA release (assessed by displacement of [11C] raclopride by oral methylphenidate) and improvement in processing speed after 4 weeks of treatment with oral methylphenidate.~The Perceptual organization and processing speed index is measured from the Digit Symbol and Symbol Searches from the Weschler Adult Intelligence Scale (WAIS-IV). The tasks that comprise the PSI, (Coding, Symbol Search), are timed and require attending to visual material, visual perception and organization, visual scanning, and hand-eye coordination. It is a standardized scale were 100 is the mean of a normal population, and each 10 points represents 1 standard deviation above or below the mean. Thus, an index of 110 is 1 SD above the mean, 90 is 1 SD below the mean."|4 weeks||||score on a scale||Standard Deviation|Mean
2595195|NCT02225080|Secondary|Occurence of Adverse Event|Adverse event that occured between days 15-30 post-operatively|Between days 15-30||||Participants|||Count of Participants
2595196|NCT02225080|Secondary|Occurence of Adverse Event|Adverse event that occured between days 4-14 post-operatively|between days 4-14||||Participants|||Count of Participants
2595197|NCT02225080|Secondary|Occurence of Adverse Event|Adverse event that occured 72 hours post-operatively|first 72 hours post-op||||Participants|||Count of Participants
2595198|NCT02225080|Primary|Patient's Outcome|Patient outcome from the procedure (recovered without sequelae, ongoing with medical intervention, ongoing with surgical intervention, deceased, other)|Day 30||||Participants|||Count of Participants
2595199|NCT02224846|Secondary|"Percentage of Participants With Yes Responses to Global Assessment Questions (GAQ)1 and GAQ2"|"Participants with yes responses to GAQ Question 1 (GAQ1) and GAQ Question 2 (GAQ2) of the GAQ questionnaire at Month 3 and Month 12.~GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity?"|Month 3, Month12, Month 24|All randomized participants who had evaluable data for Global Assessment Questions (GAQ)1 and GAQ2.|||percentage of participants|||Number
2595200|NCT02224846|Secondary|Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments|Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 6 and Month 12.|Month 6, Month 12, Month 18, Month 24|All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.|||Percentage of participants|||Number
2595201|NCT02224846|Secondary|Percentage of Participants Achieving Normal Erectile Functioning|Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 1 and Month 3.|Month 1, Month 3|All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.|||Percentage of partcipants|||Number
2595202|NCT02224846|Secondary|"Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary"|Participant-assessed diary has 5 questions(QI-Q5): 4 of the 5 questions were analyzed. Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period.|Month 1, Month 3|All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.|||Percentage of participants||Standard Deviation|Mean
2595203|NCT02224846|Secondary|Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments|IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.|Baseline, Month 6; Baseline, Month 12;Baseline, Month 18; Baseline, Month 24|All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.|||units on a scale||Standard Error|Least Squares Mean
2595204|NCT02224846|Secondary|Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score|IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.|Baseline, Month 1; Baseline, Month 3|All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.|||units on a scale||Standard Error|Least Squares Mean
2595205|NCT02224846|Primary|Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation|Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs) that lead to discontinuation. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline through Month 12|All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil.|||percentage of participants|||Number
2595206|NCT02224846|Primary|Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)|A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline through Month 12|All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil.|||Percentage of participants|||Number
2595214|NCT02224755|Secondary|New York Heart Association (NYHA) Classification|Functional status as measured by NYHA classification. NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status. Class I indicates no limitation of physical activity. Class II indicates slight limitation of physical activity. Class IIIA indicates marked limitation of physical activity where less than ordinary physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IIIB indicates marked limitation of physical activity where mild physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IV indicates inability to carry on any physical activity without discomfort.|Baseline to 24 months|Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment|||Participants|||Count of Participants
2595215|NCT02224755|Secondary|Six Minute Walk Test|Functional status as measured by the Six Minute Walk Test. The Six Minute Walk Test measures the distance a patient is able to walk during 6 minutes without running or jogging.|Baseline to 24 months|Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment. Patients unable to walk due to heart failure symptoms were assigned a distance of zero.|||meters||Standard Deviation|Mean
2595216|NCT02224755|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score|Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.|Baseline to 24 months|Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment|||score on a scale||Standard Deviation|Mean
2595217|NCT02224755|Secondary|EuroQol-5D-5L Visual Analogue Scale|Quality of life as measured by the visual analogue scale from the EuroQol-5D-5L questionnaire. The patient rates their current state of health with the visual analogue scale. The scale ranges from 0 to 100. Higher scores indicate a better quality of life.|Baseline to 24 months|Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment|||score on a scale||Standard Deviation|Mean
2595218|NCT02224755|Secondary|EuroQoL 5D-5L (EQ-5D-5L) Total Score|Quality of Life as measured by EuroQoL 5 Dimension-5 Level (EQ-5D-5L) total score. The EQ-5D-5L questionnaire has patients rate their quality of life across 5 categories of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scores from the 5 dimensions are summed for the total score which ranges from 5 to 25 with higher scores indicating more problems and a worse quality of life.|Baseline to 24 months|Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment|||score on a scale||Standard Deviation|Mean
2595219|NCT02224755|Secondary|Powered Secondary End Point: Pump Replacement at Two Years|In addition to powering the study on the primary endpoints for PMA approval, the study will pre-specify a powered secondary endpoint to evaluate incidence of pump replacements at 24 months. HeartMate II is the control.|As they occur up to 24 months or to Outcome, whichever occurs first|All subjects who underwent implant with the assigned device|||Participants|||Count of Participants
2595220|NCT02224755|Primary|Long Term Primary End Point|Survival at 2 years free of disabling stroke (Modified Rankin Score > 3) or reoperation to replace or remove a malfunctioning device|The first 366 randomized Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.|First 366 randomized Subjects|||Participants|||Count of Participants
2595221|NCT02224755|Primary|Short Term Primary End Point|Survival at 6 months free of disabling stroke (Modified Rankin Score > 3) or reoperation to replace or remove a malfunctioning device|The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first.|First 294 randomized Subjects|||Participants|||Count of Participants
2595222|NCT02224729|Secondary|Count of Participants That Experience Overall Survival (OS)|The amount of participants that start treatment with BBd and survive at least one year post treatment completion.|1 year|4 were not evaluable – (1 didn’t get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)|||Participants|||Count of Participants
2595223|NCT02224729|Secondary|Count of Participants That Experience Progression-free Survival (PFS)|The amount of participants that survive one year after treatment with BBd and do not experience worsening disease.|1 year|4 were not evaluable – (1 didn’t get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)|||Participants|||Count of Participants
2595224|NCT02224729|Secondary|Count of Participants That Experience Very Good Partial Remission (VGPR)|Very good partial remission (VGPR) to induction therapy following 4 cycles of the combination regimen BBd. As defined as no dectable M-protein on SPEP (Serum protein electrophoresis) but positive IFX (Immunofixation) on serum or urine and >90% reduction of M-protein in serum and urine|Up to 1 year|4 were not evaluable – (1 didn’t get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)|||Participants|||Count of Participants
2595225|NCT02224729|Secondary|Incidence of Grade 3-4 Adverse Events From the Combination of Bendamustine Hydrochloride, Bortezomib, and Dexamethasone Based on the Common Terminology Criteria Version 4.0|All adverse events are tracked during the course of the trial. Adverse events with a grade of 3-4 will be tracked and recorded.|Up to 1 year|4 were not evaluable – (1 didn’t get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)|||Adverse Events|||Number
2595226|NCT02224729|Primary|Count of Participants That Experience Overall Response Following 4 Cycles of the Combination Regimen BBd|ORR (partial remission or better) to induction therapy following 4 cycles of the combination regimen BBd.|At least 140 days|4 subjects were not evaluable – (1 didn’t get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)|||Participants|||Count of Participants
2595275|NCT02224313|Secondary|Vaginal Cytokines During Follow-up|Determine the changes in vaginal cytokines in postmenopausal women following treatment with estradiol then estradiol and progesterone compared to the normal menstrual cycle changes in young premenopausal women.|At 14 days and 28 days follow-up|Three premenopausal women were excluded due to missing data.|||pg/ug protein||Standard Deviation|Mean
2595227|NCT02224703|Secondary|Caregiver Global Impression Of Change (CGIC) At The Last Visit|"On Day 1 (prior to receiving study drug), the caregiver was asked to write a brief description of the participant's overall condition as a memory aid for the CGIC questionnaire at subsequent visits. The CGIC questionnaire comprised the following question, to be rated on a 7-point scale: Since your child started treatment, please assess the status of your child's overall condition (comparing their condition now to their condition before treatment) using the scale below. The markers were: Very Much Improved; Much Improved; Slightly Improved; No Change; Slightly Worse; Much Worse; Very Much Worse. The CGIC response/score, recorded at each visit, was summarized, on both a categorical and continuous scale, by treatment group. The scores at the last scheduled visit (not including the end of taper or safety follow-up visits) at which participant's last evaluation was performed were analyzed using ordinal logistic regression."|Baseline to Last Visit|Intention-to-treat (ITT) analysis set: All participants who were randomized and dosed in the trial and had post-baseline efficacy data.|||Participants|||Count of Participants
2595228|NCT02224703|Secondary|Participants With A ≥50% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period|Convulsive seizures were defined as tonic-clonic, tonic, clonic, or atonic. Participants or their caregivers recorded the number and type of convulsive seizures each day from screening until completion of dosing using an IVRS diary. Baseline included all available data prior to Day 1 (28-day average). Percentage change from baseline was calculated as: ([frequency during the treatment period - frequency during baseline]/frequency during baseline) x 100. The frequency during each period was based on 28-day averages and calculated as: (number of seizures in the period/number of reported days in the IVRS period) x 28. Baseline included all available data prior to Day 1 (28-day average).|Baseline to Day 99 or ET|Intention-to-treat (ITT) analysis set: All participants who were randomized and dosed in the trial and had post-baseline efficacy data.|||Participants|||Count of Participants
2595229|NCT02224703|Secondary|Change In Total Seizures During The Treatment Period Compared To Baseline|Total seizures were defined as the combination of convulsive and non-convulsive seizures. Convulsive seizures were defined as tonic-clonic, tonic, clonic, or atonic seizures. Non-convulsive seizures were defined as myoclonic, countable partial, other partial, or absence seizures. Participants or their caregivers recorded the number and type of convulsive seizures and non-convulsive seizures each day from screening until completion of dosing using an IVRS diary. Change compared to baseline was calculated as per the primary outcome measure. Data reported as the ratio of geometric least squares mean in total seizures and expressed as a percentage reduction.|Baseline to Day 99 or ET|Intention-to-treat (ITT) analysis set: All participants who were randomized and dosed in the trial and had post-baseline efficacy data.|||percentage reduction||95% Confidence Interval|Geometric Least Squares Mean
2595230|NCT02224703|Primary|Change In Convulsive Seizures During The Treatment Period Compared To Baseline|Convulsive seizures were defined as tonic-clonic, tonic, clonic, or atonic. Participants or their caregivers recorded the number and type of convulsive seizures each day from screening until completion of dosing using an interactive voice response system (IVRS) diary. The primary endpoint was analyzed using negative binomial regression on the sum of the convulsive seizure counts during the treatment period, based on the ITT analysis set. Baseline included all available data prior to Day 1. Data reported as the ratio of geometric least squares mean in convulsive seizures and expressed as a percentage reduction.|Baseline to Day 99 or Early Termination (ET)|Intention-to-treat (ITT) analysis set: All participants who were randomized and dosed in the trial and had post-baseline efficacy data.|||percentage reduction||95% Confidence Interval|Geometric Least Squares Mean
2595231|NCT02224690|Secondary|Subject/Caregiver Global Impression Of Change Assessment (S/CGIC)|"The S/CGIC was used to assess the participant's overall condition on a 7-point scale, using the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse, or very much worse (1 = very much improved; 7 = very much worse). On Day 1 (prior to starting IMP), the caregiver was asked to write a brief description of the participant's overall condition as a memory aid for the S/CGIC questionnaire at subsequent visits. If both a CGIC and SGIC were completed then the CGIC was used; if only a CGIC was completed then the CGIC was used; if only a SGIC was completed then the SGIC was used. Last visit for endpoints assessed at clinic visits was defined as the last scheduled visit (not including the end of taper or safety follow-up visits) at which participant's last evaluation was performed."|Baseline to Last Visit (Day 99) or ET|ITT Analysis Set: All randomized participants who received at least 1 dose of IMP and had at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.|||Participants|||Count of Participants
2595232|NCT02224690|Secondary|Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period|Total seizures included the sum of all seizures (tonic-clonic, tonic, atonic, clonic, myoclonic, countable partial, other partial and absence seizures) recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure. Negative percentages show an improvement from baseline.|Baseline to EOT (Day 99) or ET|ITT Analysis Set: All randomized participants who received at least 1 dose of IMP and had at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.|||percentage change||Inter-Quartile Range|Median
2595233|NCT02224690|Secondary|Number Of Participants With a ≥50% Reduction From Baseline in Drop Seizure Frequency During The Treatment Period|Drop seizures were recorded by the participant or caregiver using an IVRS diary. Drop seizures included the subset of tonic-clonic, tonic or atonic seizures that were reported as drop seizures in IVRS. Percentage change from baseline was calculated as per the primary outcome measure.|Baseline to EOT (Day 99) or ET|ITT Analysis Set: All randomized participants who received at least 1 dose of IMP and had at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.|||Participants|||Count of Participants
2595276|NCT02224313|Primary|Vaginal Cytokines at Baseline|Determine the differences in vaginal cytokines: interleukin (IL)-1β and IL-8 between premenopausal and postmenopausal women.|At baseline visit|One postmenopausal women was excluded due to non-compliance of assigned intervention.|||pg/ug protein||Standard Deviation|Mean
2595388|NCT02223364|Secondary|POD 0 Post-PACU Opioid Use|Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.|POD 0, approximately 12 pm to 12 am|Intent-to-treat|||mg OME||Inter-Quartile Range|Median
2595234|NCT02224690|Primary|Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period|Drop seizures were recorded by the participant or caregiver using an interactive voice response system (IVRS) diary. Drop seizures were defined as the subset of tonic-clonic, tonic or atonic seizures that were reported as drop seizures in the IVRS. Percentage change from baseline was calculated as: (frequency during the treatment period - frequency during baseline/frequency during baseline) * 100. The frequency during each period was based on 28-day averages and calculated as: (number of seizures in the period/number of reported days in the IVRS period) *28. Baseline included all available data prior to Day 1 (28-day average). Negative percentages show an improvement from baseline.|Baseline to End of Treatment (EOT) (Day 99) or Early Termination (ET)|ITT Analysis Set: All randomized participants who received at least 1 dose of IMP and had at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.|||percentage change||Inter-Quartile Range|Median
2595235|NCT02224664|Secondary|Ratio of Accumulation for Area Under the Curve From Time Zero to End of Dosing Interval of PF-06649751|Rac was obtained from AUCtau after last dose divided by AUCtau after first dose, where AUC(tau) = Area under the concentration curve from time zero to end of dosing interval (AUCtau), where dosing interval was 12 hours.|Pre-dose on Day 3, 4, 8, 11, 14, 17, 20, Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 7, 13, 22|Data was not collected since this outcome measure was not planned to be analyzed.||||||
2595236|NCT02224664|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-06649751||Pre-dose on Day 3, 4, 8, 11, 14, 17, 20, Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 7, 13, 22|The PF-06649751 PK parameter analysis set included all participants treated and who had at least 1 of the PK parameters of interest in at least 1 treatment period during period 2. Here, ‘n’ signifies those participants who were evaluable at specified time point for each reporting arm, respectively.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2595237|NCT02224664|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval of PF-06649751|Area under the concentration curve from time zero to end of dosing interval (AUCtau), where dosing interval was 12 hours.|Pre-dose on Day 3, 4, 8, 11, 14, 17, 20, Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 7, 13, 22|The PF-06649751 PK parameter analysis set included all participants treated and who had at least 1 of the PK parameters of interest in at least 1 treatment period during period 2. Here, ‘n’ signifies those participants who were evaluable at specified time point for each reporting arm, respectively.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2595238|NCT02224664|Secondary|Apparent Clearance (CL/F) of PF-06649751|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 22|The PF-06649751 PK parameter analysis set included all participants treated and who had at least 1 of the PK parameters of interest in at least 1 treatment period during period 2. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2595239|NCT02224664|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06649751||Pre-dose on Day 3, 4, 8, 11, 14, 17, 20, Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 7, 13, 22|The PF-06649751 PK parameter analysis set included all participants treated and who had at least 1 of the PK parameters of interest in at least 1 treatment period during period 2. Here, ‘n’ signifies those participants who were evaluable at specified time point for each reprting arm, respectively.|||hour||Full Range|Median
2595240|NCT02224664|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-06649751||Pre-dose on Day 3, 4, 8, 11, 14, 17, 20, Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 7, 13, 22|The PF-06649751 PK parameter analysis set included all participants treated and who had at least 1 of the PK parameters of interest in at least 1 treatment period during period 2. Here, ‘n’ signifies those participants who were evaluable at specified time points for each reporting arm, respectively.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2595241|NCT02224664|Secondary|Apparent Volume of Distribution (Vz/F) of L-Dopa|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
2595242|NCT02224664|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration of L-Dopa|Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (C last).|Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2595243|NCT02224664|Secondary|Area Under the Curve From Time Zero Extrapolated to Infinite Time of L-Dopa|AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2595244|NCT02224664|Secondary|Terminal Half-Life (t1/2) of L-Dopa|Terminal half-life is the time measured for the plasma concentration of drug to decrease by one half. It was calculated as dividing the natural logarithm to the base e (Log e)*2/k el, where k el is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||hour||Standard Deviation|Mean
2595245|NCT02224664|Secondary|Apparent Clearance (CL/F) of L-Dopa|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2595246|NCT02224664|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of L-Dopa||Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest.|||hour||Full Range|Median
2595247|NCT02224664|Secondary|Maximum Observed Plasma Concentration (Cmax) of L-Dopa||Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1|The L-Dopa pharmacokinetic (PK) parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2595248|NCT02224664|Primary|Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 20|"According to Parkinson's disease diaries of participants OFF time was a time period when the medication no longer providing benefit with regard to mobility, slowness, and stiffness and participants experienced relatively poor overall function with worsening of tremor, rigidity, balance, or bradykinesia. ON time was a time period when medication was providing benefit with regard to mobility, slowness, and stiffness. ON time was classified as associated with or without troublesome dyskinesia (TD) that interfere with activities of daily living and with or without dyskinesia. OFF time and ON time with TD were generally considered to be bad time with regard to motor function, whereas ON time without dyskinesia (WD) and with non- troublesome dyskinesia (NTD) were generally considered to be good time."|Baseline, Day 20|Safety analysis set included all participants who received at least 1 dose of study medication(L-Dopa or PF-06649751) in Period 2. Here,‘n’ signifies those participants who were evaluable at specified time points for each reporting arm. This outcome measure was not planned to be assessed in lead-in period (L-dopa).|||hour||Standard Deviation|Mean
2595249|NCT02224664|Primary|Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 13|"According to Parkinson's disease diaries of participants OFF time was a time period when the medication no longer providing benefit with regard to mobility, slowness, and stiffness and participants experienced relatively poor overall function with worsening of tremor, rigidity, balance, or bradykinesia. ON time was a time period when medication was providing benefit with regard to mobility, slowness, and stiffness. ON time was classified as associated with or without troublesome dyskinesia (TD) that interfere with activities of daily living and with or without dyskinesia. OFF time and ON time with TD were generally considered to be bad time with regard to motor function, whereas ON time without dyskinesia (WD) and with non- troublesome dyskinesia (NTD) were generally considered to be good time."|Baseline, Day 13|Safety analysis set included all participants who received at least 1 dose of study medication(L-Dopa or PF-06649751) in Period 2. Here,‘n’ signifies those participants who were evaluable at specified time points for each reporting arm.This outcome measure was not planned to be assessed in lead-in period (L-dopa).|||hour||Standard Deviation|Mean
2595250|NCT02224664|Primary|Number of Participants With Categorical Scores on The Columbia Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced any of the following 1: completed suicide, 2: suicide attempt (response of yes on actual attempt), 3: preparatory acts toward imminent suicidal behavior (yes on aborted attempt, interrupted attempt, preparatory acts or behavior), 4: any suicidal behavior or ideation, suicidal ideation (yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), 7: self-injurious behavior, no suicidal intent (yes on has participant engaged in non-suicidal self-injurious behavior)."|Baseline up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 2. This outcome measure was not planned to be assessed in lead-in period (L-dopa).|||participants|||Number
2595251|NCT02224664|Primary|Number of Participants With Clinically Significant Neurological Examination Abnormality|The complete or full neurological examination included assessment of the cranial nerves; muscle strength, tone, cortical drift, abnormal movements; deep tendon reflexes; sensory exam, coordination, gait and station. Higher cortical and motor function was considered part of the complete neurological exam. Findings were considered abnormal as confirmed by a certified neurologist.|Baseline up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2.|||participants|||Number
2595252|NCT02224664|Primary|Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings|Physical examination included examination of the head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.|Baseline up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2.|||participants|||Number
2595277|NCT02224274|Secondary|Multiplate ADP Test|"Platelet activation by adenosine diphosphate (ADP) expressed in arbitrary aggregation units (U). P2Y12 inhibitors block ADP receptors and decrease platelet activation by ADP. Higher values mean less effect of P2Y12 inhibitors, lower values mean more effect of P2Y12 inhibitors on platelets.~High on-treatment platelet reactivity was defined as >46 U."|12 hours after P2Y12 inhibitor loading||||U||Standard Deviation|Mean
2595389|NCT02223364|Secondary|PACU Opioid Use|Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.|Approximately 2 hours after entry in PACU|Intent-to-treat analysis|||mg OME||Inter-Quartile Range|Median
2595253|NCT02224664|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for ECG abnormalities: maximum PR interval >=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 msec and Pctchg>=50% for baseline value of <=200 msec for PR interval, maximum QRS interval >=140 msec and a maximum IFB: Pctchg>=50%, maximum QTCF interval (Fridericia's Correction) of 450 msec to <480 msec, 480 msec to <500 msec or >=500 msec and a maximum change of <=30change<60 or >=60 msec from baseline.|Baseline up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2595254|NCT02224664|Primary|Number of Participants With Vital Sign Abnormalities|Criteria for vital sign abnormality included supine pulse rate of <40 beats per minute (bpm) or >120 bpm, standing pulse rate of <40 bpm or >140 bpm, supine and standing systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine and standing diastolic blood pressure (DBP) <50 mmHg, supine and standing SBP of >=30 mmHg maximum (max.) increase from baseline (IFB) and and decrease from baseline (DFB) in same posture, supine and Standing DBP of >=20 mmHg max. increase and decrease from baseline in same posture. Categories in which there was atleast 1 abnormality are reported in this outcome measure.|Baseline up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2. Here, ‘n’ signifies the number of participants evaluable for the specific category.|||participants|||Number
2595255|NCT02224664|Primary|Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory abnormalities: Hemoglobin (Hgb),hematocrit, red blood cell(RBC) count: less than(<)0.8*lower limit of normal(LLN),mean corpuscular Hgb, mean corpuscular volume, mean corpuscular Hgb concentration:<0.9*LLN, greater than (>)1.1*upper limit of normal(ULN),platelet:<0.5*LLN,>1.75*ULN,lymphocyte,neutrophil:<0.8*LLN, >1.2*ULN, basophil, eosinophil, monocyte:>1.2*ULN, WBC:<0.6*LLN, >1.5*ULN;total bilirubin>1.5*ULN, aspartate aminotransferase,alanine aminotransferase,alkaline phosphatase:>3.0*ULN,total protein,albumin:<0.8*LLN,>1.2*ULN;blood urea nitrogen,creatinine:>1.3*ULN, uric acid>1.2*ULN;sodium<0.95*LLN,>1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN,>1.1*ULN;glucose<0.6*LLN,>1.5*ULN,urine pH:<4.5, >8; urine: WBC, RBC greater than or equal to (>=)20/high performance field, bacteria: >20; urobilinogen, urine: glucose, ketone, protein, Hgb, nitrite, leukocyte esterase, bilirubin: >=1.|Baseline up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2595256|NCT02224664|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study (up to Day 30) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to Day 30|Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2.|||participants|||Number
2595257|NCT02224638|Secondary|Number of Participants With Adverse Events|Adverse events related to the presence or absence of wound infections and worsening in ulcer staging.|3 weeks||||Participants|||Count of Participants
2595258|NCT02224638|Primary|Percentage of Wounds Healed|Percentage of wounds that were complete or partially healed with either treatment measured by change in wound size of sacral pressure ulcer|3 weeks||||percentage of wounds||Standard Deviation|Mean
2595259|NCT02224625|Primary|Grading Scale for Visual Evaluation of Skin Condition|"Irritation: 21 days of patching (total). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit.~Sensitization: 35 days (21 days of patching followed by 14 days rest and subsequent patch). A reviewer will assign a score based on an 8 point categorical scale to the areas treated at each visit. SLS was not tested.~Grade 0 = No irritation Grade 1 = Minimal erythema Grade 2 = Definite erythema Grade 3 = Erythema and papules Grade 4 = Edema Grade 5 = Erythema, edema and papules Grade 6 = Vesicular eruption Grade 7 = Strong reaction spreading"|21 Days for Irritation (N=39). 35 Days for Sensitization (N=249)|Participants received more than one product at a time.|||Scores Ranging (0-7)||Full Range|Mean
2595260|NCT02224612|Other Pre-specified|Change From Baseline in Respiration Rates|Change from Baseline|Baseline and 2 minutes|Respiration Rate|||Breaths per minute||Standard Deviation|Mean
2595261|NCT02224612|Secondary|Physical Fit of Pediatric Face Masks.|"Physical fit will be determined by a reviewer after the mask is put on. The fit will be based on a several fit parameters to compare the difference in the score between the two masks.~The total fit score was calculated by summing the nose to chine coverage score (0 = No, 1=Yes) and gap score (0=No apparent gap, flush to face on one or both sides, 1=Slight gap, not flush to face but can see cheeks only, 2=Moderate gap, can see mouth. , 3=Large gap, mask loose fitting all around face (chin, sides, nose, etc.) to arrive a total score with 0 indicating best fit and 4 indicating worst fit."|Immediate||||units on a scale||Standard Deviation|Mean
2595262|NCT02224612|Primary|Change From Baseline in Carbon Dioxide Levels|ETCO2 will be assessed by a capnographer when wearing each pediatric face mask. Results are the difference between masks in change from baseline.|Baseline and 2 minutes||||mmHg||Standard Deviation|Mean
2595263|NCT02224599|Secondary|Positive DTH Skin Tests With Relevant TAPA|DTH skin test will be performed on subject's forearm or within 5 cm from the site of prior DC vaccination, if possible|Days -7, 22 and 45|Enrollment was terminated||||||
2595264|NCT02224599|Secondary|Immune Response|The response of T-cells present in the peripheral blood mononuclear cells (PBMCs) population to the peptides used to pulse a patient's dendritic cell vaccine is evaluated by measuring the expression of Th1/CTL-type cytokines (IFN-γ and/or TNF-α and/or IL-17) by a standard ELI-Spot assay using 500,000 PBMCs per experimental replicate and a minimum of 3 experimental replicates for each stimulation. The results are expressed as the average number of spots obtained from the stimulation of 500,000 PBMCs|Days -7, 22 and 45|Enrollment was teriminated.||||||
2595266|NCT02224560|Secondary|Subject/Caregiver Global Impression Of Change (S/CGIC) Assessment|"The S/CGIC was used to assess the participant's overall condition on a 7-point scale, using the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse, or very much worse (1 = very much improved; 7 = very much worse). On Day 1 (prior to starting IMP), the caregiver was asked to write a brief description of the participant's overall condition as a memory aid for the S/CGIC questionnaire at subsequent visits. If both a CGIC and SGIC were completed then the CGIC was used; if only a CGIC was completed then the CGIC was used; if only a SGIC was completed then the SGIC was used. Last visit for endpoints assessed at clinic visits was defined as the last scheduled visit (not including the end of taper or safety follow-up visits) at which participant's last evaluation was performed."|Baseline to Last Visit (Day 99) or ET|ITT Analysis Set: Received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.|||Participants|||Count of Participants
2595267|NCT02224560|Secondary|Percentage Change From Baseline In Total Seizure Frequency During The Treatment Period|Total seizures included the sum of all seizures (tonic-clonic, tonic, atonic, clonic, myoclonic, countable partial, other partial, and absence seizures) recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure. Negative percentages show an improvement from baseline.|Baseline to EOT (Day 99) or ET|ITT Analysis Set: Received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.|||percentage change||Inter-Quartile Range|Median
2595268|NCT02224560|Secondary|Number Of Participants With A ≥50% Reduction From Baseline In Drop Seizure Frequency During The Treatment Period|Drop seizures were recorded by the participant or caregiver using an IVRS diary. Drop seizures included the subset of tonic-clonic, tonic, or atonic seizures that were reported as drop seizures in IVRS. Percentage change from baseline was calculated as per the primary outcome measure.|Baseline to EOT (Day 99) or ET|ITT Analysis Set: Received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.|||Participants|||Count of Participants
2595269|NCT02224560|Primary|Percentage Change From Baseline In Drop Seizure Frequency During The Treatment Period|Drop seizures were recorded by the participant or caregiver using an interactive voice response system (IVRS) diary. Drop seizures were defined as the subset of tonic-clonic, tonic or atonic seizures that were reported as drop seizures in the IVRS. Percentage change from baseline was calculated as: ([frequency during the treatment period - frequency during baseline]/frequency during baseline) x 100. The frequency during each period was based on 28-day averages and calculated as: (number of seizures in the period/number of reported days in the IVRS period) x 28. Baseline included all available data prior to Day 1 (28-day average). Negative percentages show an improvement from baseline.|Baseline to End of Treatment (EOT) (Day 99) or Early Termination (ET)|ITT Analysis Set: Received at least 1 dose of IMP with at least 1 post-baseline efficacy endpoint measurement. Participants were analyzed according to the treatment group to which they were randomized.|||percentage change||Inter-Quartile Range|Median
2595270|NCT02224508|Secondary|Depressive Symptoms|Patient Health Questionnaire (PHQ-8) depression scale. The PHQ-8 is estimated by summing the 8 scale items. The total score ranges from 0 to 24, with higher scores indicating greater depression severity. Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.|2 weeks prior to interview||||units on a scale||95% Confidence Interval|Mean
2595271|NCT02224508|Secondary|Pain Severity (Intensity, Interference With Activities, Enjoyment): PEG Scale|PEG (Pain - Enjoyment - Interference with General Activities) pain scale consisting of the average of 3 0-10 ratings of pain intensity, interference with activities due to pain, and reduced enjoyment of life due to pain. Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The PEG score ranges from 0 to 30, with higher scores indicating greater pain severity. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.|1 week prior to interview||||units on a scale||95% Confidence Interval|Mean
2595272|NCT02224508|Primary|Proportion With Prescription Opioid Use Disorder (Defined by DSM5 Criteria).|Proportion with Prescription Opioid Use Disorder, which is defined by multiple indicators of opioid abuse and addiction from 9 criteria in the DSM5 manual of the American Psychiatric Association. In this research, it will be assessed using the Psychiatric Research Interview for Substance and Mental Disorders (PRISM5, Columbia University). Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.|1 year prior to interview|Prevalent chronic opioid therapy (COT) patients defined as having received at least 70 days supply of opioids in the 90 days prior to sample selection, at least 70 days supply of opioids in at least one of the 3 other quarters in the preceding year, and at least 45 days supply of opioids in the other two quarters.|||proportion of COT patients||95% Confidence Interval|Number
2595273|NCT02224404|Secondary|Evaluate the Level of Pain at Week 6 Changes in Wound Status, Clinician's and Subject's Opinion, and Technical Performance|Pain during product removal at week 6, measured by Visual Analog scale.This will be measured by the following variables; visual analog scale, 0=no pain, 100= worst pain, scale from 0-100 mm|6 weeks||||units on a scale||Inter-Quartile Range|Median
2595274|NCT02224404|Primary|Number of Participants With Worsening in Peri-Skin Wound.(Maceration From Baseline to 6 Weeks)|the subjects will be measured by the following variables; maceration,|6 weeks||||participants|||Number
2595390|NCT02223364|Secondary|Intraoperative Opioid Use|Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.|During the procedure, approximately 2 hours after start of the procedure|Intent-to-treat analysis|||mg OME||Inter-Quartile Range|Median
2595278|NCT02224274|Secondary|VerifyNow P2Y12Test - % Inhibition|% inhibition reflects P2Y12 inhibitor effect regarding basal platelet reactivity (defined as: (1- (platelet reactivity/basal platelet reactivity)) x 100). Higher values mean better P2Y12 inhibition response. High on-treatment platelet reactivity was defined as <11% inhibition.|12 hours after P2Y12 inhibitor loading||||% inhibition||Standard Deviation|Mean
2595279|NCT02224274|Primary|VerifyNow P2Y12Test - Platelet Reactivity|Platelet reactivity reflects P2Y12 inhibitor effect. Higher values mean normal platelet reactivity due to low P2Y12 inhibition response, while lower values mean decreased platelet reactivity due to the effect of a P2Y12 inhibitor. High on-treatment platelet reactivity was defined as >208 PRU.|12 h after P2Y12 inhibitor loading||||PRU||Standard Deviation|Mean
2595280|NCT02224157|Primary|Annual Severe Asthma Exacerbation Rate - Superiority Analysis|Severe asthma exacerbations over the randomised treatment period, negative binomial model for superiority test evaluation|up to 52 weeks|Full analysis set|||exacerbations per participant year||95% Confidence Interval|Least Squares Mean
2595281|NCT02224157|Secondary|Average Change From Baseline in Asthma Quality of Life Questionnaire Standardised Version - AQLQ(S) Score|AQLQ(S) consists of 32 questions in 4 domains. Each question is assessed on a 7-point scale from 1 to 7, with higher values indicating better health-related quality of life. The overall score is calculated as the mean score of all 32 items. The average change from baseline to treatment period average in AQLQ(S) overall score was derived by computing a contrast for the mean across all post-randomisation visits (week 17, 34, 52) from the MMRM (mixed model repeated measures) analysis.|Study weeks 0,17, 34, 52|Full Analysis Set.|||AQLQ(S) overall score||95% Confidence Interval|Least Squares Mean
2595282|NCT02224157|Secondary|Average Change From Baseline in Asthma Control Questionnaire (5-item Version) - ACQ-5 Score|ACQ questionnaire contains five questions on patients' symptoms, which are assessed on a 7-point scale from 0 (representing good control) to 6 (representing poor control). The score is the mean score of all questions for which responses are provided. The average change from baseline to treatment period average in ACQ-5 was derived by computing a contrast for the mean across all post-randomisation visits (week 17, 34, 52) from the MMRM (mixed model repeated measures) analysis.|Study weeks 0, 17, 34, 52|Full analysis set.|||Score||95% Confidence Interval|Least Squares Mean
2595283|NCT02224157|Secondary|Percentage of Controller Use Days|ICS controller use days (%) during the randomised treatment period is calculated as the cumulative days when any controller medication (containing ICS) was taken including maintenance (Pulmicort bid group) and 'as needed' medication (Symbicort 'as needed' group) and additional prescribed ICS for asthma (all treatment groups), divided by the number of days in the randomised treatment period.|Week 0 up to 52 weeks|Full analysis set|||Percentage of days||95% Confidence Interval|Least Squares Mean
2595284|NCT02224157|Secondary|Change From Baseline in Percent of 'as Needed' Free Days|'As needed' free days (%) change from baseline during randomised treatment period. An 'as-needed' free day was defined as a day and night with no use of 'as needed' medication. Variable analysed is the percentage (%) of 'as-needed' free days during the randomised treatment period. Baseline is defined by the last 10 days of the run-in period.|Week 0 up to 52 weeks|Full analysis set|||Percentage of 'as needed' free days||95% Confidence Interval|Least Squares Mean
2595285|NCT02224157|Secondary|Average Change From Baseline in 'as Needed' Use|'As-needed' use change from baseline over the randomised treatment period. Baseline was defined as the last 10 days of the run-in period. 'As needed' use was calculated as the cumulative doses of 'as-needed' medication over the randomised treatment period divided by the follow-up time (number of days - 1). ie, average number of inhalations per day.|Week 0 up to 52 weeks|Full analysis set.|||Number of inhalations per day||95% Confidence Interval|Least Squares Mean
2595286|NCT02224157|Secondary|Number of Participants With Study Specific Asthma Related Discontinuation|The following two criteria lead to discontinuation from the IP due to asthma related events: A severe asthma exacerbation with duration for more than 3 weeks, and/or three severe asthma exacerbations during 6 months.|Day 1 up to 52 weeks|Full analysis set|||Participants|||Number
2595287|NCT02224157|Secondary|Average Change From Baseline in Pre-bronchodilator FEV1|The average change from baseline (baseline defined by measurement at week 0, prior to first dose of IP) to the treatment period average assessed over the entire treatment period in pre-bronchodilator FEV1 was derived by computing a contrast for the mean across the post-randomisation visits (week 17, 34, 52) from the MMRM (mixed model repeated measures) analysis.|Study weeks 0,17, 34, 52|Full analysis set|||mL||95% Confidence Interval|Least Squares Mean
2595288|NCT02224157|Secondary|Number of Participants Experiencing at Least One Severe Asthma Exacerbation|A severe exacerbation is defined as a deterioration of asthma requiring any of the following: use of systemic glucocorticosteroids (GCS) for at least 3 days, inpatient hospitalization, or emergency room visit due to asthma that required systemic steroids.|Day 1 up to 52 weeks|Full analysis set|||Participants|||Number
2595289|NCT02224157|Primary|Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis|Severe asthma exacerbations over the randomised treatment period, negative binomial model for non-inferiority test evaluation|up to 52 weeks|Full analysis set|||exacerbations per participant year||95% Confidence Interval|Least Squares Mean
2595290|NCT02224053|Secondary|Parent to Metabolite Ratios of AZ5104 and AZ7550 AUC|Assessment of the PK of AZ5104 and AZ7550 AUC using the parent (AZD9291) to metabolite ratios|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||Ratio||Full Range|Geometric Mean
2595291|NCT02224053|Secondary|Parent to Metabolite Ratios of AZ5104 and AZ7550 Cmax|Assessment of the PK of AZ5104 and AZ7550 Cmax using the parent (AZD9291) to metabolite ratios|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||Ratio||Full Range|Geometric Mean
2595335|NCT02223650|Secondary|Proportion of Subjects With Near Control Treatment Response|"A comparison of the proportion of subjects showing a treatment response, defined as an improvement of at least 1 point in near control (mean of the 3 assessments over the exam) between enrollment and 8 weeks."|8 weeks||||participants|||Number
2595292|NCT02224053|Secondary|AUC of AZ5104 and AZ7550|Area under the plasma concentration-time curve from zero to infinity of AZ5104 and AZ7550 (metabolites to AZD9291)|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM.h||Full Range|Geometric Mean
2595293|NCT02224053|Secondary|Cmax of AZ5104 and AZ7550|Assessment of the PK of AZ5104 and AZ7550 (metabolites to AZD9291) using the maximum plasma concentration, Cmax|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM||Full Range|Geometric Mean
2595294|NCT02224053|Secondary|Vz/F of AZD9291|Assessment of the PK of AZD9291 using the apparent volume of distribution, Vz/F|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||L||Full Range|Geometric Mean
2595295|NCT02224053|Secondary|CL/F of AZD9291|Assessment of the PK of AZD9291 using the apparent plasma clearance, CL/F|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||L/h||Full Range|Geometric Mean
2595296|NCT02224053|Secondary|λz|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using the terminal rate constant, λz|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||1/h||Full Range|Geometric Mean
2595297|NCT02224053|Secondary|t(1/2)|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using the terminal half-life, t(1/2)|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||h||Full Range|Geometric Mean
2595298|NCT02224053|Secondary|Tlag|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using lag time before observation of quantifiable analyte concentrations in plasma, tlag|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||h||Full Range|Median
2595299|NCT02224053|Secondary|Tmax|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using time to reach maximum plasma concentration, tmax|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||h||Full Range|Median
2595300|NCT02224053|Secondary|AUC(0-72)|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using area under the plasma concentration curve from time zero to 72 hours, AUC(0-72)|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM.h||Full Range|Geometric Mean
2595301|NCT02224053|Secondary|AUC(0-t)|Assessment of the PK of AZD9291 (parent compound), AZ5104 (metabolite) and AZ7550 (metabolite) using area under the plasma concentration curve from zero extrapolated to o the time of the last quantifiable concentration, AUC(0-t)|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM.h||Full Range|Geometric Mean
2595302|NCT02224053|Primary|Cmax of AZD9291|Rate and extent of absorption of AZD9291 following single oral doses of AZD9291 tablet formulation by assessment of maximum plasma concentration (Cmax).|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose.|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM||Full Range|Geometric Mean
2595303|NCT02224053|Primary|AUC of AZD9291|Area under the plasma concentration-time curve from zero to infinity for AZD9291|PK samples collected in both period 1 and 2 at pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 120, 168, 216, 336, and 504 hours post AZD9291 dose|Pharmacokinetic population - all subjects who received at least 1 dose of AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM.h||Full Range|Geometric Mean
2608985|NCT02071290|Primary|ROTEM EXTEM ML|Change in ROTEM parameter maximum lysis (ML) over 24 hours from Admission|0 (Admission), 1, 3, 24 hours||||Percent||Inter-Quartile Range|Median
2595304|NCT02223871|Post-Hoc|Drug-specific Parasite Reduction Ratio (PRR48) of ACT-451840 Over 48 Hours Using a New Approach|"After the blood stage Plasmodium falciparum challenge (BSPC), malaria parasitemia was measured by polymerase chain reaction (PCR) in regularly collected blood samples.~The subject-specific and drug-specific parasite reduction rates over a 48 h period (PRR48) were calculated following the data-driven method by Marquart et al. (2015), removing potential lag and tail phases prior to log-linear regression modeling."|48 hours after study drug administration|Only subjects with appropriate overall fit (p-value of the overall model F-test <0.001) were taken into account (n = 8 with the method described by Marquart et al., 2015)|||Ratio||95% Confidence Interval|Mean
2595305|NCT02223871|Secondary|Change From Baseline in Respiratory Rate to End of Study (EOS)||Day 28 (EOS)||||Breaths/min||Full Range|Median
2595306|NCT02223871|Secondary|Change From Baseline in Body Temperature up to End of Study (EOS)|Body temperature was measured orally|Day 28 (EOS)||||Degree Celsius||Full Range|Median
2595307|NCT02223871|Secondary|Change From Baseline in Blood Pressure to End of Study (EOS)|Vital signs, including diastolic and systolic blood pressure (DBP/SBP), were measured at each outpatient visit up to 7 days after ACT-451840 administration, every day during confinement or when malaria symptoms were presented and at the end of study visit (EOS). Other measures were performed if required.|Day 28 (EOS)||||mmHg||Full Range|Median
2595308|NCT02223871|Secondary|Terminal Half-life [t(1/2)]|Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose|From pre-dose to144 hours after study drug adminsitration|Per protocol set|||Hours||95% Confidence Interval|Geometric Mean
2595309|NCT02223871|Secondary|Areas Under the Plasma Concentration-time Curve of ACT-451840|"Two AUCs were calculated using non-compartmental analysis: AUC(0-t) from pre-dose to last time-point of measure and AUC(0-inf) from pre-dose and extrapolated to infinity.~Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose"|From pre-dose to144 hours after study drug administration||||ng*h/mL||95% Confidence Interval|Geometric Mean
2595310|NCT02223871|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of ACT-451840|tmax was directly derived from the plasma concentration-time curves of ACT-451840. Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose.|From pre-dose to144 hours after study drug administration||||Hours||Full Range|Median
2595311|NCT02223871|Secondary|Maximum Plasma Concentration (Cmax) of ACT-451840|Cmax was directly derived from the plasma concentrations-time curves of ACT-451840. Blood samples for pharmacokinetic characterization were drawn at pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 48, 72, 96, and 144 hours post-dose.|From pre-dose to 144 hours after study drug adminsitration||||ng/mL||95% Confidence Interval|Geometric Mean
2595312|NCT02223871|Primary|Drug-specific Parasite Reduction Ratio (PRR48) of ACT-451840 Over 48 Hours Using a Standardized Approach|"After the blood stage Plasmodium falciparum challenge (BSPC), malaria parasitemia was measured by polymerase chain reaction (PCR) in regularly collected blood samples.~The subject-specific and drug-specific parasite reduction rates over a 48 h period (PRR48) were calculated using an objective standardized approach (observed data over 48 h)"|48 hours after study drug administration|Only subjects with appropriate overall fit (p-value of the overall model F-test <0.001) were taken into account (n = 5)|||Ratio||95% Confidence Interval|Mean
2595313|NCT02223858|Other Pre-specified|Patient Global Assessment of Pain From Baseline to 1, 3, and 6 Months Post-intervention|Self-reported global assessment of pain in the last week using a numeric rating scale. Global assessment of pain is on a scale of 0-10; higher scores mean worse pain.|Baseline to 6 months post-intervention|Participants had the option to skip any questions they did not wish to answer. This explains why the number analyzed in the rows below differs from the overall number analyzed.|||units on a scale||Standard Deviation|Mean
2595314|NCT02223858|Primary|Self-reported Physical Functioning From Baseline to 1, 3, and 6 Months Post-intervention|Difficulty with physical functioning subscale of the Western Ontario McMaster (WOMAC) Index. Physical functioning is on a scale of 0-100; higher scores mean worse physical functioning.|Baseline to 6 months post-intervention|Participants had the option to skip any questions they did not wish to answer. This explains why the number analyzed in the rows below differs overall number analyzed.|||units on a scale||Standard Deviation|Mean
2595315|NCT02223858|Primary|Self-reported Pain From Baseline to 1, 3, and 6 Months Post-intervention|Pain subscale of the Western Ontario McMaster (WOMAC) Index. Pain is on a scale of 0-100; higher scores mean worse pain.|Baseline to 6 months post-intervention|Participants had the option to skip any questions they did not wish to answer. This explains why the number analyzed in the rows below differs overall number analyzed.|||units on a scale||Standard Deviation|Mean
2595316|NCT02223793|Other Pre-specified|Effect of Heart Age and Tailord CVD Advice After 1 Year|Comparing results from blood samples after 4 weeks in 23 pharmacies (enhanced CVD communication) versus 25 pharmacies (general communication of CVD risk).N|4 weeks||2019-10-31|10/2019||||
2595317|NCT02223793|Secondary|8-week Change in Total Cholesterol|Change in total cholesterol, from date of randomization and until the end of the follow up after 8 weeks.|At baseline and at 8 weeks|Difference between three groups.|||mmol/L||95% Confidence Interval|Mean
2595318|NCT02223793|Primary|Change in ad Hoc Risk Score (Measure on a Scale From Min 4 to Max 14)|"The (ad hoc) risk score was a summarization of points ranging from 0 (favorable measures) , 2 (slighly unfavourable) or 4 (very unfavorable measures) assigned for each of Total cholesterol, HDL-cholesterol, HbA1c, blood pressure, body mass index and age (age was included because presence of elevated cardiovascular disease risk factors is more alarming in younger age).~Risk points for each risk factor was summarized into an total risk score ranging from 4 (min) to 14 (max). A total risk score of ≥4 served as inclusion criteria because it indicated moderately elevated risk of cardiovascular disease."|Baseline and at 8 weeks|Between groups analysis|||units on a scale||95% Confidence Interval|Mean
2595319|NCT02223754|Primary|Contact Lens Fitting|Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.|8- 12 Days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||Percentage of Subject Eyes|Subject Eyes||Number
2595320|NCT02223754|Primary|Limbal Conjunctival Injection|The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.|8- 12 Days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||Percentage of Subject Eyes|Subject Eyes||Number
2595321|NCT02223754|Primary|Bulbar Conjunctival Injection|The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.|8- 12 Days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||Percentage of Subject Eyes|Subject Eyes||Number
2595322|NCT02223754|Primary|Corneal Staining|Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.|8 - 12 Days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.|||percentage of Subject Eyes|Subject Eyes||Number
2595323|NCT02223754|Primary|Near Binocular Visual Acuity (LogMAR)|Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||LogMAR||Standard Deviation|Mean
2595324|NCT02223754|Primary|Intermediate Binocular Visual Acuity (LogMAR)|Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||LogMAR||Standard Deviation|Mean
2595325|NCT02223754|Primary|Distance Binocular Visual Acuity (LogMAR)|Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.|8- 12 Days post wear|The analysis population consists of subjects that have completed all study visits without a major protocol deviation.|||LogMAR||Standard Deviation|Mean
2595326|NCT02223754|Primary|Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire|CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).|8 -12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||units on a scale||Standard Deviation|Mean
2595327|NCT02223715|Secondary|Recurrence or Not After 2 Months Follow-up|"The patients were observed from the diagnosis to the end of the treatment and got a telephone follow up call after two month from the end of treatment.~Unknown includes patient lost, data missing"|From the time of CDI diagnosis to 2 months follow-up||||participants|||Number
2595328|NCT02223715|Secondary|Clinical Complication|This study was non-interventional observational study. There were no restriction on the CDI treatment and we did not define to collect AE data. We just defined to collect the data for complications with CDI treatments indicating below. The complications to be checked were defined in the protocol. The information of other complications and AEs were not collected.|From the time of CDI diagnosis to recovery or recurrence||||participants|||Number
2595329|NCT02223715|Primary|Status at the End of CDI Episode|The patients were observed from the diagnosis to the end of the treatment and got a telephone follow up call after two month from the end of treatment. The categories of the status indicating below are at the end of the treatment, not at the follow up call. Lost to follow-up means the patient number who were lost during the treatment course.|From the time of CDI diagnosis to the end of the treatment||||participants|||Number
2595330|NCT02223715|Primary|Patient Demographics|Medical history is information which was collected at the CDI diagnosis in this study. The items of the Medical history are indicated below. Concomitant diseases at the CDI diagnosis were included in the Medical history.|At the study at the time of CDI diagnosis enrollment|Medical history is information which was collected at the CDI diagnosis in this study. The items of the Medical history are indicated below. Concomitant diseases at the CDI diagnosis were included in the Medical history.|||participants|||Number
2595331|NCT02223702|Secondary|The Attachment Loss Were Considered as a Secondary Measure.|Attachment loss were recorded at baseline, 1st, 3rd and 6th months as millimeters. The data were compared among and between groups.|6-months||||mm||Standard Deviation|Mean
2595332|NCT02223702|Primary|The Primary Outcome Variable Was Probing Depth.|We measured the probing depth at baseline, 1st, 3rd and 6th months. The changes were evaluated among and between groups.|6-months||||mm||Standard Deviation|Mean
2595333|NCT02223689|Secondary|Change in Pain Following Application|Any 1 point decrease, increase, or no change in pain was measured on a scale--0 =no pain = 5 most pain.|15 minutes Post Application|Participants were asked 15 min after application to rate any change in pain as decreased, increased or no change.|||percent of participants|||Number
2595334|NCT02223689|Primary|Wound Closure at Discharge|Wounds remained closed following application of Skin Affix|14 days||||percent of participants|||Number
2595336|NCT02223650|Secondary|Symptom Survey Response to Question: Has Your Child Reported Blurry Vision?|A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.|8 weeks||||participants|||Number
2595337|NCT02223650|Secondary|Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?|A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.|8 weeks|Spectacle-related questions at follow up apply only to observation participants prescribed correction (N=10 (32%) and to all overminus group participants N=27 (100%)).|||participants|||Number
2595338|NCT02223650|Secondary|Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?|A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.|8 weeks||||participants|||Number
2595339|NCT02223650|Secondary|Binocular Near Visual Acuity|Binocular near visual acuity was tested in habitual correction using the ATS4 near visual acuity test. The treatment groups were not different with respect to 8-week control at near.|8 weeks||||prism diopters||Standard Deviation|Mean
2595340|NCT02223650|Secondary|Distance Visual Acuity|Monocular distance visual acuity testing with the habitual correction and without cycloplegia was measured using the Amblyopia Treatment Study HOTV testing protocol on any certified visual acuity system. The treatment groups were not different with respect to 8-week control PACT at distance|8 weeks||||prism diopters||Standard Deviation|Mean
2595341|NCT02223650|Secondary|Stereoacuity|Stereoacuity will be assessed with habitual correction using the Randot Preschool stereotest at near (performed at 40 cm). A specific level of stereoacuity is not required for eligibility.|8 weeks||||log arcsecond||Standard Deviation|Mean
2595342|NCT02223650|Secondary|Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?|A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.|8 weeks|Spectacle-related questions at follow up apply only to observation participants prescribed correction (N=10 (32%) and to all overminus group participants N=27 (100%)).|||participants|||Number
2595343|NCT02223650|Secondary|Proportion of Subjects With Distance Control Treatment Response|"A comparison of the proportion of subjects showing a treatment response, defined as an improvement of at least 1 point in distance control (mean of the 3 assessments over the exam) between enrollment and 8 weeks."|8 weeks||||participants|||Number
2595344|NCT02223650|Secondary|Distribution of Near Control Score at 8-week Outcome|Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.|8 weeks||||participants|||Number
2595345|NCT02223650|Secondary|Distribution of Distance Control Score at 8-week Outcome|Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.|8 weeks||||participants|||Number
2595346|NCT02223650|Secondary|Mean Near Exotropia Control Score|"At each visit, control of the exodeviation was measured at near (1/3 meters) using the Office Control Score which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a triple control score, which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The secondary analysis was an intention-to-treat treatment group comparison of mean 8-week near control using an analysis of covariance (ANCOVA) model which adjusted for baseline near control."|8 weeks||||points on control score scale||Standard Deviation|Mean
2595347|NCT02223650|Primary|Mean Distance Exotropia Control Score|"At each visit, control of the exodeviation was measured at distance (6 meters) and at near (1/3 meters) using the Office Control Score* which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a triple control score, which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The primary analysis was an intention-to-treat treatment group comparison of mean 8-week distance control using an analysis of covariance (ANCOVA) model which adjusted for baseline distance control.~*Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus 2006;14(3):147-50."|8 weeks||||points on control score scale||Standard Deviation|Mean
2595391|NCT02223364|Secondary|Preoperative Daily Opioid Use|Opioid consumption will be documented in the patient electronic medical record by the nursing staff caring for the patient.|baseline|Intent-to-Treat Analysis|||mg oral morphine equivalents (OME)||Inter-Quartile Range|Median
2595348|NCT02223637|Primary|Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy|"A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator.~Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW."|From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon exposure to Menveo within 28 days prior to conception or at any time during pregnancy until the estimated delivery date)|The analysis was performed on the live births who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the pregnancy|||Percentage of LBW live birth without MCM|||Number
2595349|NCT02223637|Secondary|Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy|The pregnancy outcomes assessed were: Live births,stillbirths, SAB, IAB, ectopic pregnancy, molar pregnancy and others.|From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon exposure to Menveo within 28 days prior to conception or at any time during pregnancy until the estimated delivery date)|The analysis was performed on subjects who were exposed to Menveo vaccine within 28 days prior to pregnancy or at any time during the pregnancy.|||Pregnancy outcomes|||Number
2595350|NCT02223637|Secondary|Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Third Trimester|The pregnancy outcomes assessed were: Live births, stillbirths, SAB,IAB, ectopic pregnancy, molar pregnancy and others.|From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during third trimester of pregnancy (>27 weeks) until the estimated delivery date)|The analysis was performed on subjects who were exposed to Menveo vaccine during the third trimester of pregnancy|||Pregnancy outcomes|||Number
2595351|NCT02223637|Secondary|Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Vaccine During the Second Trimester|The pregnancy outcomes assessed were: live births, stillbirths, SAB, IAB, ectopic pregnancy, molar pregnancy and others|From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during second trimester of pregnancy [14-27 weeks] until the estimated delivery date)|The analysis was performed on subjects who were exposed to Menveo vaccine during the second trimester of pregnancy|||Pregnancy outcomes|||Number
2595352|NCT02223637|Secondary|Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo During the First Trimester|The pregnancy outcomes assessed were: live births, stillbirths, SABs, IABs, ectopic pregnancy, molar pregnancy and others.|From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during first trimester of pregnancy [0-13 weeks] until the estimated delivery date)|The analysis was performed on subjects who were exposed to Menveo vaccine during the first trimester of pregnancy|||Pregnancy outcomes|||Number
2595353|NCT02223637|Secondary|Number of Pregnancy Outcomes Reported for Subjects Exposed to Menveo Within 28 Days Prior to Conception|"The pregnancy outcomes assessed were: live births, stillbirths, SABs, IABs, ectopic pregnancy, molar pregnancy and others.~Spontaneous abortions (SABs) are defined as fetal death or expulsion of products of conception prior to 20 weeks gestation.~Induced abortions (IABs) are defined as voluntary interruption of pregnancy, including pregnancy termination that occurs electively, to preserve maternal health, or due to fetal abnormalities.~Stillbirths are defined as fetal death occurring at 20 weeks gestation or greater, or if gestation age is unknown, a fetus weighing 500 g or more.~Ectopic pregnancy is defined as implantation of a conception outside of the uterus.~Molar pregnancy is defined as a conception that results in a gestational trophoblastic tumor."|From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure within 28 days prior to conception until the estimated delivery date)|The analysis was performed on subjects who were exposed to Menveo vaccine within 28 days prior to conception|||Pregnancy outcomes|||Number
2595354|NCT02223637|Primary|Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Third Trimester|A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW.|From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during third trimester of pregnancy (>27 weeks) until the estimated delivery date)|The analysis was performed on the live births who were exposed to Menveo vaccine during the third trimester of pregnancy|||Percentage of LBW live birth without MCM|||Number
2595355|NCT02223637|Primary|Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the Second Trimester|A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW.|From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during second trimester of pregnancy [14-27 weeks] until the estimated delivery date)|The analysis was performed on the live births who were exposed to Menveo vaccine during the second trimester of pregnancy|||Percentage of LBW live birth without MCM|||Number
2595356|NCT02223637|Primary|Percentage of LBW Live Births Reported on Exposure to Menveo Vaccine During the First Trimester|A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW.|From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during first trimester of pregnancy [0-13 weeks] until the estimated delivery date)|The analysis was performed on live births who were exposed to Menveo vaccine during the first trimester of pregnancy|||Percentage of LBW live birth without MCM|||Number
2595392|NCT02223364|Secondary|Maximum Pain POD 2 (24 Hours)|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|POD 2, approximately 12 am to 12 am next day|Intent-to-Treat Analysis. For POD 2, data are missing for 5 subjects (1 on PNB arm, 1 on PAI-R arm, and 3 on PAI-L arm).|||units on a scale||Inter-Quartile Range|Median
2595357|NCT02223637|Primary|Percentage of Low Birth Weight (LBW) Live Births Reported on Exposure to Menveo Vaccine Vaccine Within 28 Days Prior to Conception|A pregnancy outcome that is reported as a LBW birth represents an infant whose birth weight is <2500 g. The prevalence rate of LBW was calculated as a proportion, with the number of LBW infants as the numerator and the number of live births as the denominator. Infants with MCMs were excluded from the analysis of this outcome measure as MCMs are often associated with LBW.|From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure within 28 days prior to conception until the estimated delivery date)|The analysis was performed on live births who were exposed to Menveo vaccine within 28 days prior to conception|||Percentage of LBW live birth without MCM|||Number
2595358|NCT02223637|Primary|Percentage of Preterm Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception or at Any Time During the Pregnancy|A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined.|From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon exposure to Menveo within 28 days prior to conception or at any time during pregnancy until the estimated delivery date)|The analysis was performed on the live births who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the mother's pregnancy|||Percentage of preterm births without MCM|||Number
2595359|NCT02223637|Primary|Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Third Trimester|A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined.|From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during third trimester of pregnancy (>27 weeks) until the estimated delivery date)|The analysis was performed on the live births who were exposed to Menveo vaccine during the third trimester of pregnancy|||Percentage of preterm births without MCM|||Number
2595360|NCT02223637|Primary|Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the Second Trimester|A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined.|From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during second trimester of pregnancy [14-27 weeks] until the estimated delivery date)|The analysis was performed on the live births who were exposed to Menveo vaccine during the second trimester of pregnancy|||Percentage of preterm births without MCM|||Number
2595361|NCT02223637|Primary|Percentage of Preterm Births Reported on Exposure to Menveo Vaccine During the First Trimester|A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined.|From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during first trimester of pregnancy [0-13 weeks] until the estimated delivery date)|The analysis was performed on the live births who were exposed to Menveo vaccine during the first trimester of pregnancy|||Percentage of preterm births without MCM|||Number
2595362|NCT02223637|Primary|Percentage of Preterm Births Reported on Exposure to Menveo Vaccine Within 28 Days Prior to Conception|A pregnancy outcome that is reported with a preterm birth represents an infant born at a gestational age under (<) 37 weeks. The prevalence rate of preterm birth was calculated as a proportion, with the number of preterm births as the numerator and the number of live births as the denominator. Because MCMs are often associated with preterm birth and LBW, infants with MCMs were excluded from analyses of this outcome measure and were not counted in the numerator or denominator when prevalence rate was determined.|From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure within 28 days prior to conception until the estimated delivery date)|The analysis was performed on live births who were exposed to Menveo vaccine within 28 days prior to conception|||Percentage of preterm births without MCM|||Number
2595363|NCT02223637|Primary|Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Within 28 Days Prior to Conception or at Any Time During the Pregnancy|The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births|From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon exposure to Menveo within 28 days prior to conception or at any time during pregnancy until the estimated delivery date)|The analysis was performed on live births who were exposed to Menveo vaccine within 28 days prior to conception or at any time during the pregnancy|||Percentage of Live Births with MCM|||Number
2595387|NCT02223364|Secondary|POD 1 Opioid Use|Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.|POD 1, approximately 12 am to 12 am next day|Intent-to-treat analysis|||mg OME||Inter-Quartile Range|Median
2595364|NCT02223637|Primary|Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During Third Trimester|The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine during the third trimester of pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births|From the time of enrolment until the date of pregnancy outcome documentation (i.e.From registration upon Menveo exposure during third trimester of pregnancy [>27 weeks] until the estimated delivery date)|The analysis was performed on live births who were exposed to Menveo vaccine during third trimester of pregnancy|||Percentage of Live Births with MCM|||Number
2595365|NCT02223637|Primary|Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the Second Trimester|The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine during the second trimester of pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births|From the time of enrolment until the date of pregnancy outcome documentation (i.e. from registration upon Menveo exposure during second trimester of pregnancy [14-27 weeks] until the estimated delivery date)|The analysis was performed on live births who were exposed to Menveo vaccine during second trimester of pregnancy|||Percentage of Live Births with MCM|||Number
2595366|NCT02223637|Primary|Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Vaccine During the First Trimester|The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine during the first trimester of pregnancy.The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births.|From the time of enrolment until the date of pregnancy outcome documentation (i.e.From registration upon Menveo exposure during first trimester of pregnancy [0-13 weeks] until the estimated delivery date)|The analysis was performed on live births who were exposed to Menveo vaccine during the first trimester of pregnancy|||Percentage of Live Births with MCM|||Number
2595367|NCT02223637|Primary|Percentage of Live Births Reported With Major Congenital Malformations (MCM) on Exposure to Menveo Within 28 Days Prior to Conception|The pregnancy registry defined an MCM as any major structural or chromosomal defect or combination of 2 or more conditional defects in live-born infants, stillbirths, or fetal losses of any gestational age. This outcome measure was analyzed on live births reported with MCM, for subjects who were exposed to Menveo vaccine within 28 days prior to conception. The prevalence estimate of MCM was calculated as proportions of live births with MCM from the total number of live births|From the time of enrolment until the date of pregnancy outcome documentation (i.e. From registration upon Menveo exposure within 28 days prior to conception until the estimated delivery date)|The analysis was performed on live births who were exposed to Menveo vaccine within 28 days prior to conception|||Percentage of Live Births with MCM|||Number
2595368|NCT02223520|Primary|Number of Neonatal Infections With a S. Aureus Strain That is Concordant to Parental S. Aureus Strain|Primary outcome is neonatal acquisition of S. aureus strain that is concordant to parental S. aureus strain as determined by periodic surveillance cultures or a culture collected during routine clinical care that grows S. aureus. Survival analysis techniques will be used to compare the hazard of concordant colonization comparing Treatment and Control Groups.|Up to 90 days|This outcome is being assessed in the neonate population not the mothers. 12 of the neonates in the intervention group and 6 in the placebo group were lost to follow-up and could not be included in the analysis.|||neonatal S. aureus infections|||Number
2595369|NCT02223455|Primary|Hand Hygiene Compliance|Hand hygiene compliance is the primary outcome measure. Compliance rates will be determined using the same methods of direct observation of HCWs developed by Dr. Perencevich for his VA Health Services Research & Development (HSR&D) funded study (IIR 09-099). Compliance will be collected monthly throughout the project for each of the 59 units.|phase 1 (7-12 months) thru phase 3 (19-21 months)|Entry and exit HH compliance were calculated for units in each treatment group. Crude (unadjusted) change in HH compliance from baseline to follow-up was assessed for each intervention group using Fisher’s exact test.|||percentage of change in HH compliance|inpatient wards/units|95% Confidence Interval|Mean
2595370|NCT02223429|Secondary|Mean Percent Signal Change in Right Lateral Septum|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between AVP treatment and placebo treatments (AVP-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the AVP group only per protocol.|Baseline, Visit 2 (Up to 10 days)|The analysis was conducted in the AVP groups only per protocol. One person from each order of administration were excluded from the analysis due to motion issues in their imaging data.|||Percent signal change||Standard Deviation|Mean
2595371|NCT02223429|Secondary|Mean Percent Signal Change in Primary Auditory Cortex|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the OT group only per protocol.|Baseline, Visit 2 (Up to 10 days)|The analysis was completed per protocol for the OT + placebo group only.|||Percent signal change||Standard Deviation|Mean
2595372|NCT02223429|Secondary|Difference in Cry Rating Scores Between AVP and Placebo|"The effect of the drug will be assessed by analyzing the differences between ratings of infant cries under AVP and placebo treatment on a 7-point likert scale. Sixteen adjectives will be used to describe two different cries. Participants will rate each cry from 1-7 where one represents not at all and 7 represents extremely. Difference is defined as AVP minus placebo scores."|Baseline, Visit 2 (Up to 10 days)|Analysis was completed according to protocol for all participants who were administered AVP in combination with placebo at any time point during the study.|||units on a scale||Standard Deviation|Mean
2595842|NCT02217878|Primary|Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-12h)|Exposure to ticagrelor during the first 12 hours after ticagrelor loading dose|prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose||||ng*h/mL||Standard Deviation|Mean
2595373|NCT02223429|Secondary|Difference in Cry Rating Scores Between OT and Placebo|"The effect of the drug will be assessed by analyzing the differences between ratings of infant cries under OT and placebo treatment on a 7-point likert scale. Sixteen adjectives will be used to describe two different cries. Participants will rate each cry from 1-7 where one represents not at all and 7 represents extremely. Difference is defined as OT minus placebo scores."|Baseline, Visit 2 (Up to 10 days)|Of the 15 participants who were administered oxytocin in combination with placebo at any time point during the study, data were analyzed for 14 participants. One participant was excluded from the analysis due to missing data.|||units on a scale||Standard Deviation|Mean
2595374|NCT02223429|Secondary|Change in Plasma Levels of Oxytocin (OT)|Peripheral levels of OT will be assessed via assay of plasma collected.|Baseline, Visit 2 (Up to 10 days)|Zero participants were analyzed as samples were not assayed.||||||
2595375|NCT02223429|Secondary|Change in Plasma Levels of Vasopressin (AVP)|Peripheral levels of AVP will be assessed via assay of plasma collected.|Baseline, Visit 2 (Up to 10 days)|Zero participants were analyzed as AVP samples were not assayed.||||||
2595376|NCT02223429|Primary|Mean Percent Signal Change in the Anterior Cingulate Cortex|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).|Baseline, Visit 2 (Up to 10 days)|Analysis was conducted in the OT+placebo groups only.|||Percent signal change||Standard Deviation|Mean
2595377|NCT02223429|Primary|Mean Percent Signal Change in the Visual Cortex|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).|Baseline, Visit 2 (Up to 10 days)|The analysis was completed per protocol for the OT + placebo groups only.|||Percent signal change||Standard Deviation|Mean
2595378|NCT02223429|Primary|Mean Percent Signal Change in Caudate Nucleus|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI).|Baseline, Visit 2 (Up to 10 days)|The analysis was completed per protocol for the OT + placebo groups only.|||Percent signal change||Standard Deviation|Mean
2595379|NCT02223429|Primary|Mean Percent Signal Change in Right Medial Orbitofrontal Cortex|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the OT group only per protocol.|Baseline, Visit 2 (Up to 10 days)|The analysis was completed per protocol for the OT + placebo groups only.|||Percent signal change||Standard Deviation|Mean
2595380|NCT02223429|Primary|Mean Percent Signal Change in Right Ventral Striatum|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the OT group only per protocol.|Baseline, Visit 2 (Up to 10 days)|The analysis was completed per protocol for the OT + placebo groups only.|||Percent signal change||Standard Deviation|Mean
2595381|NCT02223429|Primary|Mean Percent Signal Change in Ventral Tegmental Area (VTA)|The effect of the drug will be assessed by determining changes in brain activation to own child pictures versus adult pictures (O-A) between OT treatment and placebo treatments (OT-PL) from functional magnetic resonance imaging (fMRI). Changes will be assessed in the OT group only per protocol.|Baseline, Visit 2 (Up to 10 days)|The analysis was completed per protocol for the OT + placebo groups only.|||Percent signal change||Standard Deviation|Mean
2595382|NCT02223390|Primary|HIV Medication Adherence (% Adherent)|Assessed through biomarkers of dried blood spots (DBS) testing for presence of antiretroviral therapy (ART) (tenofovir, emtricitabine, and efavirenz) at 6 month assessment, supplemented by viral load (VL; considered adherent if VL <=40 copies/ml) when DBS unavailable. Outcome dichotomized.|180 days|Subset of participants newly initiating ART (excluding re-initiators and non-initiators; n=54, 49 with biomarker data)|||Participants|||Count of Participants
2595383|NCT02223390|Primary|PTSD Symptoms|Self-report, measured by the PTSD checklist, civilian version (PCL-5). 20-item self-report questionnaire, assessed severity of symptoms that parallel the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria for PTSD. Participants were asked to indicate the extent to which they were bothered by problems experienced in the past month in relation to a traumatic experience of abuse or act of violence (0 = not at all to 4 = extremely). Total severity score (range: 0-80; higher scores indicating higher symptom severity, >= 33 indicating PTSD) and subscale totals (Avoidance - Cluster C, range: 0-8, higher scores indicating higher avoidance symptom severity; and Hyperarousal - Cluster E, range: 0-24, higher scores indicating higher hyperarousal symptom severity) were examined.|90 Days, 180 days||||score on a scale||Standard Error|Mean
2595384|NCT02223364|Secondary|Balance Testing on Operative Leg Using Unipedal Stance Time|In order to measure clinical balance, unipedal stance time (UST) was collected as an indicator of balance and fall risk. Timing (in seconds) began upon withdrawal of support and continued until the uplifted foot returned to the floor, the subject required support, or if the subject reached a time limit of 30 seconds. The best performance of three repetitions was recorded for analysis. Normative values for the UST are available. A UST threshold of 30 seconds yields a sensitivity of 95% and a specificity of 58% in identifying those with a history of falls. The first five seconds of unipedal stance is indicative of dynamic balance; inability to maintain unipedal stance for five seconds is a significant predictor of injurious falls.|baseline, approximately 12 weeks|Intent-to-treat analysis|||seconds||Inter-Quartile Range|Median
2595385|NCT02223364|Secondary|Hospital Length of Stay|The hospital length of stay was measured from the date of admittance until the date of discharge.|Approximately 3 days|Intent-to-treat analysis|||days||Inter-Quartile Range|Median
2595386|NCT02223364|Secondary|POD 2 Opioid Use|Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.|POD 2, approximately 12 am to 12 am next day|Intent-to-treat analysis. For POD 2, data are missing for 5 subjects (1 on PNB arm, 1 on PAI-R arm, and 3 on PAI-L arm).|||mg OME||Inter-Quartile Range|Median
2596906|NCT02203578|Primary|Incidence of cGVHD||At 6 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.||||||
2595393|NCT02223364|Secondary|Average Pain POD 2 (24 Hours)|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|POD 2, approximately 12 am to 12 am next day|Intent-to-Treat Analysis. For POD 2, data are missing for 5 subjects (1 on Peripheral Nerve Block (PNB) arm, 1 on Ropivacaine (PAI-R) arm, and 3 on Liposomal Bupivacaine (PAI-L) arm).|||units on a scale||Inter-Quartile Range|Median
2595394|NCT02223364|Secondary|Maximum Pain POD 1 (24 Hours)|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|POD 1, approximately 12 am to 12 am next day|Intent-to-Treat Analysis|||units on a scale||Inter-Quartile Range|Median
2595395|NCT02223364|Secondary|Average Pain POD 1 (24 Hours)|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|POD 1, approximately 12 am to 12 am next day|Intent-to-Treat Analysis|||units on a scale||Inter-Quartile Range|Median
2595396|NCT02223364|Secondary|Maximum Pain Post-PACU|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|Post-operative Day 0, approximately 12 pm to 12 am|Intent-to-Treat Analysis|||units on a scale||Inter-Quartile Range|Median
2595397|NCT02223364|Secondary|Average Pain Post-Postanesthesia Care Unit (PACU)|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|Post-operative Day 0, approximately 12 pm to 12 am|Intent-to-Treat analysis|||units on a scale||Inter-Quartile Range|Median
2595398|NCT02223364|Primary|Maximum Pain Post-Operative Day (POD) 1 (Morning)|Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.|Post-Operative Day 1, approximately 6 am to 12:00 pm|Intent-to-Treat Analysis|||units on a scale||Inter-Quartile Range|Median
2595399|NCT02223351|Other Pre-specified|Apparent Volume of Distribution (Vd/F) of ASP1955888-00|ASP1955888-00 is a metabolite of the study drug (ASP2151)|Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention||||L||Standard Deviation|Mean
2595400|NCT02223351|Other Pre-specified|Apparent Total Body Clearance (CL/F) From Plasma of ASP1955888-00|ASP1955888-00 is a metabolite of the study drug (ASP2151)|Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention||||L/h||Standard Deviation|Mean
2595401|NCT02223351|Other Pre-specified|Half-life (t1/2) of ASP1955888-00|ASP1955888-00 is a metabolite of the study drug (ASP2151)|Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention||||h||Geometric Coefficient of Variation|Geometric Mean
2595402|NCT02223351|Other Pre-specified|Area Under the Curve (AUC) of ASP1955888-00|ASP1955888-00 is a metabolite of the study drug (ASP2151)|Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2595403|NCT02223351|Other Pre-specified|Time of Peak Concentration (Tmax) of ASP1955888-00|ASP1955888-00 is a metabolite of the study drug (ASP2151)|Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention||||h||Full Range|Median
2595404|NCT02223351|Other Pre-specified|Peak Plasma Concentration (Cmax) of ASP1955888-00|ASP1955888-00 is a metabolite of the study drug (ASP2151)|Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2595405|NCT02223351|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Refer to the result of adverse event.|Up to 31 days||||participants|||Number
2595406|NCT02223351|Primary|Apparent Volume of Distribution (Vd/F) of ASP2151||Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention||||L||Standard Deviation|Mean
2595407|NCT02223351|Primary|Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma||Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention||||L/h||Standard Deviation|Mean
2595408|NCT02223351|Primary|Half-Life (t1/2) of ASP2151||Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention||||h||Geometric Coefficient of Variation|Geometric Mean
2595409|NCT02223351|Primary|Area Under the Curve (AUC) of ASP2151||Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2595410|NCT02223351|Primary|Time of Peak Concentration (Tmax) of ASP2151||Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention||||h||Full Range|Median
2595411|NCT02223351|Primary|Peak Plasma Concentration (Cmax) of ASP2151||Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2595412|NCT02223338|Secondary|Average Number of Antibiotics to Which Isolated Organisms Were Resistant|Average number of antibiotics to which isolated organisms were resistant, isolated organisms include only coagulase negative Staphylococcus species and Staphylococcus aureus. Antibiotics are those described in the methods section.|Through study completion, average of 4 weeks|All isolates of coagulase negative Staphylococcus and Staphylococcus aureus|||antibiotics||Standard Deviation|Mean
2595425|NCT02223260|Primary|Central Measurement: The Mean aPTT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|Central measurement: The mean activated partial thromboplastin time (aPTT) coagulation time at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.|2 h, and 12 h after dosing on day 1|PKS|||second||Standard Deviation|Mean
2595426|NCT02223260|Primary|Plasma Concentrations of Total Dabigatran, 2h and 12 h (+/-2h) Post Administration of Dabigatran Etexilate|Plasma concentrations of total dabigatran, 2h and 12 h (+/-2h) post administration of dabigatran etexilate.|2 hours (h) and 12h after drug administration on day 1|Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least 1 PK/PD observation and had no important Protocol violations (PVs) with respect to statistical analysis of Pharmacokinetic (PK) or Pharmacodynamic (PD ) endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2595413|NCT02223338|Primary|Number of Participants With Resistance of Ocular Flora to Commonly Used Post-injection Prophylactic Antibiotics|"Resistance of all coagulase negative staph and staph aureus species to a panel of commonly used antibiotics will be determined and compared between groups. Resistance will be measured using minimum inhibitory concentrations which will be tested on the Siemens MicroScan instrument by doubling broth dilutions. Antibiotic susceptibility interpretations using the categories S for susceptible, I for Intermediate and R for Resistance based on the Clinical and Laboratory Standards Institute (CLSI) guidelines.~Ciprofloxacin will be tested using the Biomerieux E test strip. The test directly quantifies antimicrobial susceptibility in terms of discrete MIC values on a continuous gradient strip. The MIC values are also based on the CLSI guidelines giving interpretations of S, I or R.~For information on other antibiotics to be tested, please contact the investigator or provide more characters for input."|Cultured organisms will be subjected to resistance panels once they have grown and been identified. Cultures will be followed for 7 days total, and if no growth is recorded at that time they will be considered sterile.|All culture positive samples growing Staphylococcus aureus or coagulase negative Staphylococcus species.|||Participants|||Count of Participants
2595414|NCT02223260|Secondary|Global Assessment of Acceptability and Tolerability of Study Medication|The investigator was to provide a global clinical assessment of tolerability and acceptability of study medication by the patient.This assessment was based on 5-point scale (good, satisfactory, not satisfactory, bad, not assessable).|Day 1 (immediately after dosing)|Treated set|||percentage of participants|||Number
2595415|NCT02223260|Secondary|Incidence of All AEs During the Treatment Period|Percentage of patients with all adverse events (AEs) during the treatment period (including REP).|Within two days after the administration of trial medication, up to 3 days|Treated set|||percentage of participants|||Number
2595416|NCT02223260|Secondary|Incidence of All Bleeding Events (Major, CRNM and Minor) During the Treatment Period.|"Percentage of patients with Incidence of all bleeding events(major, clinically relevant non-major (CRNM) & minor) during the treatment period (including the residual effect period).Bleeding events were classified as follow:~Major bleeding: 1) Fatal bleeding 2) Clinically overt bleeding associated with decrease in haemoglobin of at least 2 g/dL (20 g/L) in 24-h-period 3) Bleeding that was retroperitoneal, pulmonary, intracranial, or otherwise involved the central nervous system 4) Bleeding that required surgical intervention in an operating suite. CRNM bleeding: 1) Overt bleeding for which a blood product was administered & which was not directly attributable to the patient's underlying medical condition 2) Bleeding that required medical or surgical intervention to restore haemostasis, other than in an operating suite. Minor bleeding defined as any overt or macroscopic evidence of bleeding that did not fulfil the criteria for either major bleeding or CRNM bleeding."|Within two days after the administration of trial medication, up to 3 days|Treated set|||Percentage of participants|||Number
2595417|NCT02223260|Secondary|PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters dTT Values.|Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters dTT (AntiFactor IIa activity) values. For our simple regression model, R-squared is equal to the square of Pearson's coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit.|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS|||R-Square|||Number
2595418|NCT02223260|Secondary|PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters ECT Values.|Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters ECT values. For our simple regression model, R-squared is equal to the square of Pearson's coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit.|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS|||R-Square|||Number
2595419|NCT02223260|Secondary|PK-PD Relationship: Relationship Between Total Dabigatran Plasma Concentration and Coagulation Parameters APTT Values.|Linear regression models were used for modeling the relationship between total dabigatran plasma concentration and coagulation parameters APTT values. For our simple regression model, R-squared is equal to the square of Pearson's coefficient of correlation. The R-squared can be between 0 and 1. R-squared =1 means a perfect fit.|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS|||R-Square|||Number
2595420|NCT02223260|Primary|Central Measurement: The Mean of dTT Ratio at 2h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|"Central measurement: The mean of dTT (AntiFactor IIa activity) ratio at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.~dTT ratio= dTT(post dose)/dTT(baseline). The mean of dTT ratio is presented."|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS|||ratio||Standard Deviation|Mean
2595421|NCT02223260|Primary|Central Measurement: The Mean ECT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|"Central measurement: The mean Ecarin Clotting Time (ECT) ratio at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.~ECT ratio= ECT(Post dose)/ECT(baseline), The mean of ECT ratio is presented."|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS|||Ratio||Standard Deviation|Mean
2595422|NCT02223260|Primary|Central Measurement: The Mean aPTT Ratio at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|"Central measurement: The mean aPTT (activated partial thromboplastin time) ratio at 2 h and 12 h (±2 h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.~aPTT ratio= aPTT (post dose)/aPTT (baseline). The mean of aPTT ratio is presented."|baseline (0.5 h before intake of study medication), 2 h, and 12 h after dosing on day 1|PKS|||ratio||Standard Deviation|Mean
2595423|NCT02223260|Primary|Central Measurement: The Mean of Diluted Thrombin Time (dTT) Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|Central measurement: The mean of dTT (AntiFactor IIa activity) coagulation time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.|2 h, and 12 h after dosing on day 1|PKS|||second||Standard Deviation|Mean
2595424|NCT02223260|Primary|Central Measurement: The Mean of ECT Coagulation Time at 2 h and 12h (+/-2h) Post Administration of Dabigatran Etexilate.|Central measurement: The mean of Ecarin Clotting Time (ECT) coagulation time at 2 h and 12h (+/-2h) post administration of dabigatran etexilate. Standard deviation is actually the Coefficient of Variation.|2 h, and 12 h after dosing on day 1|PKS|||second||Standard Deviation|Mean
2595427|NCT02223065|Primary|Dapagliflozin AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf])|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population|||ng.h/mL||90% Confidence Interval|Geometric Mean
2595428|NCT02223065|Primary|Saxagliptin AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf])|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population|||ng.h/mL||90% Confidence Interval|Geometric Mean
2595429|NCT02223065|Primary|Dapagliflozin AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population|||ng.h/mL||90% Confidence Interval|Geometric Mean
2595430|NCT02223065|Primary|Saxagliptin AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population|||ng.h/mL||90% Confidence Interval|Geometric Mean
2595431|NCT02223065|Primary|Dapagliflozin Maximum Observed Concentrations (Cmax)|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1 to 3 (Period 1) and Day 8 to 10 (Period 2)|Evaluable PK Population|||ng/mL||90% Confidence Interval|Geometric Mean
2595432|NCT02223065|Primary|Saxagliptin Maximum Observed Concentrations (Cmax)|5-mg saxagliptin/10-mg dapagliflozin as a Fixed-dose Combination (FDC) and as Individual Tablets together in the fasted state|Day 1-3 (Period 1) and Day 8-10 (Period 2)|Evaluable PK Population|||ng/mL||90% Confidence Interval|Geometric Mean
2595433|NCT02222870|Secondary|Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine|Geometric titer ratios of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.|Day 28 post-final vaccination|Geometric mean titer ratios were assessed in the Per-Protocol Analysis Set.|||Titer ratio||95% Confidence Interval|Geometric Mean
2595434|NCT02222870|Secondary|Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine|Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion is defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer.|Day 28 post-final vaccination|Seroconversion was assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
2595435|NCT02222870|Secondary|Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine|Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after the final vaccination.|Day 0 (pre-vaccination) and Day 28 post-final vaccination|Seroprotection was assessed in the Per-Protocol Analysis Set.|||Percentage of participants|||Number
2595436|NCT02222870|Secondary|Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine|Geometric titers of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 28 post-final vaccination|Geometric mean titers were assessed in the Per-Protocol Analysis Set.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
2595437|NCT02222870|Primary|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine|"Solicited Injection-site: 6 to < 36 months - Tenderness, Erythema, and Swelling; 3 to < 9 years - Pain, Erythema, and Swelling. Solicited systemic reactions: 6 to < 36 months - Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability; 3 to < 9 years - Fever, Headache, Malaise, and Myalgia.~Grade 3: Fever, > 39.5˚C (6 to < 36 months), ≥ 39.0˚C (3 to < 9 years); Vomiting, ≥ 6 episodes/24 hours or requires parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping often/difficult to wake; Appetite lost, Refuses ≥ 3 or most meals; Irritability, Inconsolable; Headache, Malaise, and Myalgia, Significant, prevents daily activity."|Day 0 up to Day 7 post-any injection|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.|||Percentage of participants|||Number
2595438|NCT02222818|Secondary|Percentage of Effective CRT Pacing During AF (Superiority Test)|The secondary objective is to demonstrate that the percent effective CRT pacing during AF when CAFRPlus is applied is greater than when CAFR is applied (superiority test).|Up to 4 months|Randomized subjects who had paired measurements available from both CAFR period and CAFRPlus period.|||percentage of effective CRT pacing||Standard Deviation|Mean
2595439|NCT02222818|Primary|Percentage of Effective CRT Pacing During AF (Non-inferiority Test)|The primary objective is to demonstrate that the percent effective CRT pacing during AF when CAFRPlus is applied is not inferior to when CAFR is applied (non-inferiority test).|Up to 4 months|Randomized subjects who had paired measurements available from both CAFR period and CAFRPlus period.|||percentage of effective CRT pacing||Standard Deviation|Mean
2595440|NCT02222714|Secondary|PK of 3K3A-APC by Compartmental Analysis (Half-life)|Measured following a single dose; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|Following a single dose, on Day 1, 2 or 3: End of infusion (EOI) and 20, 40, 60 and 80 minutes following EOI|The PK population included all subjects who had sufficient data for PK analysis, and who had not been excluded from analysis for protocol deviations that could impact the calculation or interpretation of the PK parameters.|||hr||Geometric Coefficient of Variation|Geometric Mean
2595441|NCT02222714|Secondary|PK of 3K3A-APC by Compartmental Analysis (λz)|Measured following a single dose; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|Following a single dose, on Day 1, 2 or 3: End of infusion (EOI) and 20, 40, 60 and 80 minutes following EOI|The PK population included all subjects who had sufficient data for PK analysis, and who had not been excluded from analysis for protocol deviations that could impact the calculation or interpretation of the PK parameters.|||1/hr||Geometric Coefficient of Variation|Geometric Mean
2608986|NCT02071290|Primary|ROTEM EXTEM Alpha Angle|Change in ROTEM parameter Alpha Angle over 24 hours from Admission|0 (Admission), 1, 3, 24 hours||||Degrees||Inter-Quartile Range|Median
2595442|NCT02222714|Secondary|PK of 3K3A-APC by Compartmental Analysis (AUC[0-inf])|Measured following a single dose; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|Following a single dose, on Day 1, 2 or 3: End of infusion (EOI) and 20, 40, 60 and 80 minutes following EOI|The PK population included all subjects who had sufficient data for PK analysis, and who had not been excluded from analysis for protocol deviations that could impact the calculation or interpretation of the PK parameters.|||hr▪ng/mL||Geometric Coefficient of Variation|Geometric Mean
2595443|NCT02222714|Secondary|PK of 3K3A-APC by Compartmental Analysis (Cmax)|Measured following a single dose; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|Following a single dose, on Day 1, 2 or 3: End of infusion (EOI) and 20, 40, 60 and 80 minutes following EOI|The PK population included all subjects who had sufficient data for PK analysis, and who had not been excluded from analysis for protocol deviations that could impact the calculation or interpretation of the PK parameters.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2595444|NCT02222714|Secondary|PK of 3K3A-APC by Compartmental Analysis (Volume of Distribution)|Measured following a single dose; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|Following a single dose, on Day 1, 2 or 3: End of infusion (EOI) and 20, 40, 60 and 80 minutes following EOI|The PK population included all subjects who had sufficient data for PK analysis, and who had not been excluded from analysis for protocol deviations that could impact the calculation or interpretation of the PK parameters.|||mL||Geometric Coefficient of Variation|Geometric Mean
2595445|NCT02222714|Secondary|PK of 3K3A-APC by Compartmental Analysis (Clearance)|Measured following a single dose; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|Following a single dose, on Day 1, 2 or 3: End of infusion (EOI) and 20, 40, 60 and 80 minutes following EOI|The PK population included all subjects who had sufficient data for PK analysis, and who had not been excluded from analysis for protocol deviations that could impact the calculation or interpretation of the PK parameters.|||mL/hr||Geometric Coefficient of Variation|Geometric Mean
2595446|NCT02222714|Secondary|Number of Participants With a Presence of Measurable Bleeds in the Brain (Hemorrhage and Microbleeds) as Determined by 1.5T MRI|MRI examination to include—at minimum—T1 and T2 weighted images, as well as diffusion weighted imaging (DWI) and susceptibility weighted imaging (SWI) sequences. Post-tPA microbleeds—defined as hypointensities less than 5mm in diameter seen on SWI—will be counted as tPA-related only if found within the ischemic territory. All other areas of hypointensity on SWI larger than 5mm diameter will be counted as tPA-related regardless of the territory in which they are found. All treated subjects (regardless of dose) will be compared to all placebo subjects using a Pearson chi-square test.|Day 30|Subjects with a Day 30 scan collected.|||Participants|||Count of Participants
2595447|NCT02222714|Primary|Number of Participants With Adverse Events That Meet Dose-limiting Toxicity (DLT) Criteria Specified in Protocol|Specific AEs in the study were defined in the protocol to be dose-limiting toxicity events. Any given patient was adjudicated in a binary way to either have had a DLT or not to have had a DLT.|48-hours following last dose|Evaluable participants|||Participants|||Count of Participants
2595448|NCT02222558|Primary|Percentage of Responders|Percentage of subjects with response to treatment within each period. Response to treatment was considered when Testosterone Cavg was within the physiological range of Testosterone concentration, i.e. 300 - 1050 ng/dL.|Cavg from samples at Period 1: post dose hrs 0,1,2,3,4,5,6,8,12,16,24; Period 2: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 BID: hrs 0,2,3,4,5,6,8,12,14,15,16,17,18,20,24; Period 3 TID: hrs 0,2,3,4,5,6,8,10,11,12,13,14,16,18,19,20,21,22,24|Subjects who received TSX-002 and provided PK concentrations for the protocol required 24 hour collection periods.|||percentage of subjects|||Number
2595449|NCT02222493|Secondary|Serum Concentration Versus Time Summary: Period 3||Pre dose on Day 379, 435 and 547|Pharmacokinetic population: all treated participants from per protocol (PP) population, who had at least 1 post-dose drug concentration measurement during Period 1. PP population: all participants who were randomized and received the study treatment as planned up to Week 14, with no major protocol deviations.|||nanograms/milliliters||Standard Deviation|Mean
2595450|NCT02222493|Secondary|Serum Concentration Versus Time Summary: Period 2||Pre dose on Day 211, 267, 379 and 547|Pharmacokinetic population: all treated participants from per protocol (PP) population, who had at least 1 post-dose drug concentration measurement during Period 1. PP population: all participants who were randomized and received the study treatment as planned up to Week 14, with no major protocol deviations.|||nanograms/milliliters||Standard Deviation|Mean
2595451|NCT02222493|Secondary|Serum Concentration Versus Time Summary: Period 1||Pre dose on Day 1, 15, 43, 99, 155 and 211; 2 hours post dose on Day 1 and 99; and 336 hours post dose on Day 29|Pharmacokinetic population: all treated participants from per protocol (PP) population, who had at least 1 post-dose drug concentration measurement during Period 1. PP population: all participants who were randomized and received the study treatment as planned up to Week 14, with no major protocol deviations.|||nanograms/milliliters||Standard Deviation|Median
2595452|NCT02222493|Secondary|Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3|ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.|Baseline (Week 54 pre-dose) up to Week 78|Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.|||participants|||Number
2595453|NCT02222493|Secondary|Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2|ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.|Baseline (Week 30 pre-dose) up to Week 54|Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.|||participants|||Number
2595454|NCT02222493|Secondary|Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1|ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.|Baseline (Day 1) up to Week 30|Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.|||participants|||Number
2595455|NCT02222493|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3||Baseline (Week 54 pre-dose), Week 62, 70 and 78|"The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||milligrams/litres||Standard Deviation|Mean
2595456|NCT02222493|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2||Baseline (Week 30 pre-dose), Week 38, 46 and 54|"The ITT Population was defined as all participants who were randomized to study treatment. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||milligrams/litres||Standard Deviation|Mean
2595457|NCT02222493|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1||Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30|"The ITT Population was defined as all participants who were randomized to study treatment. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||milligram/litres||Standard Deviation|Mean
2595458|NCT02222493|Secondary|Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3|"PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, Considering all the ways your arthritis affects you, how are you feeling today? and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity."|Baseline (Week 54 pre-dose), Week 62, 70 and 78|"The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
2595459|NCT02222493|Secondary|Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2|"PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, Considering all the ways your arthritis affects you, how are you feeling today? and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity."|Baseline (Week 30 pre-dose), Week 38, 46 and 54|"The ITT Population was defined as all participants who were randomized to study treatment. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
2595460|NCT02222493|Secondary|Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1|"PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, Considering all the ways your arthritis affects you, how are you feeling today? and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity."|Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30|"The ITT Population was defined as all participants who were randomized to study treatment. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
2595461|NCT02222493|Secondary|Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3|Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.|Baseline (Week 54 pre-dose), Week 62, 70 and 78|"The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||joints||Standard Deviation|Mean
2595462|NCT02222493|Secondary|Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2|Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.|Baseline (Week 30 pre-dose), Week 38, 46 and Week 54|"The ITT Population was defined as all participants who were randomized to study treatment. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||joints||Standard Deviation|Mean
2595527|NCT02221947|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Evaluate the safety and tolerability of bryostatin 1 (hereinafter referred to as bryostatin) in patients with Alzheimer's Disease (AD) following a single intravenous (IV) dose.|Within 2 weeks of study drug dosing||||event|||Number
2595463|NCT02222493|Secondary|Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1|Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.|Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and Week 30|"The ITT Population was defined as all participants who were randomized to study treatment. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||joints||Standard Deviation|Mean
2595464|NCT02222493|Secondary|Number of Participants With Laboratory Abnormalities: Period 3|Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 3 were reported in this outcome measure.|Baseline (Week 54 pre-dose) up to Week 78|"Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||participants|||Number
2595465|NCT02222493|Secondary|Number of Participants With Laboratory Abnormalities: Period 2|Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 2 were reported in this outcome measure.|Baseline (Week 30 pre-dose) up to Week 54|"Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||participants|||Number
2595466|NCT02222493|Secondary|Number of Participants With Laboratory Abnormalities: Period 1|Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 1 were reported in this outcome measure.|Baseline (Day 1) up to Week 30|"Safety population was defined as all participants who are randomized and receive at least 1 dose of study treatment, analyzed by actual treatment received. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||participants|||Number
2595467|NCT02222493|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3|AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.|Baseline (Week 54 pre-dose) up to Week 78|Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.|||participants|||Number
2595468|NCT02222493|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2|AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.|Baseline (Week 30 pre-dose) up to Week 54|Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.|||participants|||Number
2595469|NCT02222493|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1|AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.|Baseline (Day 1) up to Week 30|Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.|||participants|||Number
2595470|NCT02222493|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 78 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.|Baseline (Week 54 pre-dose) up to Week 78|Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.|||participants|||Number
2595471|NCT02222493|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 54 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.|Baseline (Week 30 pre-dose) up to Week 54|Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.|||participants|||Number
2595472|NCT02222493|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 30 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to Week 30|Safety population was defined as all participants who were randomized and received at least 1 dose of study treatment, analyzed by actual treatment received.|||participants|||Number
2595473|NCT02222493|Secondary|Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3|EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.|Week 62, 70 and Week 78|The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.|||participants|||Number
2595474|NCT02222493|Secondary|Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2|EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.|Week 38, 46 and Week 54 (pre-dose)|The ITT Population was defined as all participants who were randomized to study treatment.|||participants|||Number
2595475|NCT02222493|Secondary|Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1|EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.|Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)|The ITT Population was defined as all participants who were randomized to study treatment.|||participants|||Number
2595476|NCT02222493|Secondary|Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3|ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =<1 or the score on the SDAI was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.|Week 62, 70 and 78|The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.|||participants|||Number
2595477|NCT02222493|Secondary|Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2|ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =<1 or the score on the SDAI was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.|Week 38, 46 and 54 (pre-dose)|The ITT Population was defined as all participants who were randomized to study treatment.|||participants|||Number
2595478|NCT02222493|Secondary|Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1|ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and patient's global assessment of arthritis (PGA) all were less than or equal to (=<) 1 or the score on the simplified disease activity index (SDAI) was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.|Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)|The ITT Population was defined as all participants who were randomized to study treatment.|||participants|||Number
2595479|NCT02222493|Secondary|Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3|DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.|Baseline (Week 54 pre-dose), Week 62, 70 and 78|"The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
2595480|NCT02222493|Secondary|Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2|DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 millimeter [mm]; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.|Baseline (Week 30 pre-dose), Week 38, 46 and 54|"The ITT Population was defined as all participants who were randomized to study treatment. Here, Number of Participants Analyzed signifies participants who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
2595481|NCT02222493|Secondary|Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1|DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on visual analogue scale [VAS] from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) less than (<)2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and greater than (>) 5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.|Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30|The ITT Population was defined as all participants who were randomized to study treatment.|||units on a scale||Standard Deviation|Mean
2595482|NCT02222493|Secondary|Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3|ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.|Week 62, 70 and 78|The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.|||participants|||Number
2595483|NCT02222493|Secondary|Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2|ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.|Week 38, 46 and 54 (pre-dose)|The ITT Population was defined as all participants who were randomized to study treatment.|||participants|||Number
2595484|NCT02222493|Secondary|Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1|ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.|Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose)|The ITT Population was defined as all participants who were randomized to study treatment.|||participants|||Number
2595485|NCT02222493|Secondary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.|Week 62, 70 and 78|The ITT population included all participants enrolled and treated with at least 1 dose of study treatment in Period 3.|||participants|||Number
2595486|NCT02222493|Secondary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.|Week 38, 46 and 54 (pre-dose)|The ITT Population was defined as all participants who were randomized to study treatment.|||participants|||Number
2595487|NCT02222493|Secondary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1|ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.|Week 2, 4, 6, 12, 22 and 30 (pre-dose)|The ITT Population was defined as all participants who were randomized to study treatment.|||participants|||Number
2595488|NCT02222493|Primary|Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity; self-assessed disability (health assessment questionnaire-disability index [HAQ-DI]); and C-Reactive Protein (CRP).|Week 14|The ITT Population was defined as all participants who were randomized to study treatment. The primary analyses for ACR20 at Week 14 were performed with the missing data imputed using a non-responder imputation method.|||participants|||Number
2595489|NCT02222337|Secondary|Satisfaction With Care - Survivors Only - Experience of Care and Health Outcomes (ECHOS-NHL)|Satisfaction with health care received by the breast cancer survivor from her oncology health care providers or general health care providers|6-months|Some participants passed away, withdrew, or were lost to follow up after baseline. Data was missing for certain measures; numbers analyzed are adjusted accordingly. Analysis was conducted by 1) randomization, and 2) participant type.|||units on a scale||Standard Deviation|Mean
2595490|NCT02222337|Secondary|Self-Efficacy - Survivors Only - Cancer Behavior Inventory (CBI)|Self-efficacy; cancer survivors' confidence in coping with cancer and its treatment|6 Months|Some participants passed away, withdrew, or were lost to follow up after baseline. Data was missing for certain measures; numbers analyzed are adjusted accordingly. Analysis was conducted by 1) randomization, and 2) participant type.|||units on a scale||Standard Deviation|Mean
2595491|NCT02222337|Secondary|Communication - Survivors Only - Patient Satisfaction With Care (PSQ-18 Communication Subscale)|Communication with providers in terms of overall satisfaction with communication. Range for subscale is 1-5; higher scores indicate higher communication satisfaction.|6-months|Some participants passed away, withdrew, or were lost to follow up after baseline. Data was missing for certain measures; numbers analyzed are adjusted accordingly. Analysis was conducted by 1) randomization, and 2) participant type.|||units on a scale||Standard Deviation|Mean
2595492|NCT02222337|Primary|PROMIS Fatigue|Quality of life: fatigue; 4 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 4-20; A higher score = higher fatigue|6 months||||units on a scale||Standard Deviation|Mean
2595493|NCT02222337|Primary|PROMIS Depression|Quality of life: depression; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-30; A higher score = higher depression|6 months||||units on a scale||Standard Deviation|Mean
2595494|NCT02222337|Primary|PROMIS Anxiety|Quality of life: Anxiety; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6 to 30. A higher score = higher anxiety|6 months||||units on a scale||Standard Deviation|Mean
2595495|NCT02222337|Primary|PROMIS Satisfaction With Social Roles|Measure Quality of Life satisfaction with social roles domain; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10; Range of the raw score = 6-30; A higher score = higher satisfaction with social roles|6 months||||units on a scale||Standard Deviation|Mean
2595496|NCT02222337|Primary|PROMIS Physical Functioning|Measure Quality of Life physical functioning; 6 items; Sum and then use IRT to standardize the score. Mean of 50; SD of 10. Range of the raw score = 6-28; A higher score = higher physical functioning|6 months|Cancer survivors|||units on a scale||Standard Deviation|Mean
2595497|NCT02222246|Secondary|Incidence of the Need for Assistive Ventilation|Intubation or other assistive ventilation techniques - including bag, valve, or mask was performed during the ED stay; this was determined at discharge.|Following the initiation of opioid therapy until discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.|||Emergency Department Visits|Emergency Department Visits||Count of Units
2595498|NCT02222246|Secondary|Incidence of the Administration of Naloxone During Emergency Department Visit|Naloxone administered during the Emergency Department stay; this was determined at discharge.|Following the initiation of opioid therapy until discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.|||Emergency Department Visits|Emergency Department Visits||Count of Units
2595499|NCT02222246|Secondary|Incidence of the Need for Supplemental Oxygen During Emergency Department Visit|Need for supplemental oxygen during the Emergency Department stay; this was determined at discharge.|Following the initiation of opioid therapy until discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.|||Emergency Department Visits|Emergency Department Visits||Count of Units
2595509|NCT02222207|Secondary|Percentage of Participants With a Loss in BCVA of >= 10 Letters From Baseline to Study Week 12 for Study Part A|Participants were assessed at each clinic visit for BCVA using the early treatment diabetic retinopathy study chart. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward.|Baseline, Week 12|Full Analysis Set (FAS): included subjects who received at least one dose of study medication.|||percentage of participants|||Number
2596907|NCT02203578|Primary|Incidence of cGVHD||At 3 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.||||||
2595500|NCT02222246|Secondary|Incidence of Sedation During Emergency Department Visit|"Severe-to moderate sedation at any point from placement until discharge, based on sedation data collected every 30 minutes during that time period. Thus, a sedation variable was derived in which 0=no and 1=yes that moderate-severe sedation was reported by the patient at least once during the placement to discharge time interval. Sedations scoring was as follows: None was defined as awake and alert, Mild sedation was defined as responds to voice, Moderate sedation was defined as responds to touch, with or without voice and Severe sedation was defined as somnolent, difficult to arouse."|From placement in ED treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.|||Emergency Department Visits|Emergency Department Visits||Count of Units
2595501|NCT02222246|Secondary|Incidence of Respiratory Distress (YES) During Emergency Department Visit|Respiratory distress at any point from placement until discharge, based on data collected every 30 minutes during that time period. Thus, a respiratory distress variable was derived in which 0=no and 1=yes that respiratory distress was reported by the patient at least once during the placement to discharge time interval.|From placement in ED treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.|||Emergency Department Visits|Emergency Department Visits||Count of Units
2595502|NCT02222246|Secondary|Incidence of Oxygen Desaturation (< 95%) (YES) During Emergency Department Visit|Saturation of peripheral capillary oxygen < 95% (SPO2 < 95%) at any point from placement until discharge, based on SPO2 data collected every 30 minutes during that time period. Thus, a SPO2 variable was derived in which 0=no and 1=yes that SPO2 < 95% was reported by the patient at least once during the placement to discharge time interval.|From placement in ED treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.|||Emergency Department Visits|Emergency Department Visits||Count of Units
2595503|NCT02222246|Secondary|Incidence of a Decrease in Diastolic Blood Pressure Greater Than or Equal to 20% of Baseline During Emergency Department Visit|Decrease in diastolic blood pressure at any point from placement until discharge, based on blood pressure data collected every 30 minutes during that time period. A diastolic variable was derived in which 0=no and 1=yes that a > 20% decrease of baseline diastolic blood pressure was reported by the patient at least once during the placement to discharge time interval.|From placement in ED treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.|||Emergency Department Visits|Emergency Department Visits||Count of Units
2595504|NCT02222246|Secondary|Incidence of a Decrease in Systolic Blood Pressure Greater Than or Equal to 20% of Baseline During Emergency Department Visit|Decrease in systolic blood pressure at any point from placement until discharge, based on blood pressure data collected every 30 minutes during that time period. A systolic variable was derived in which 0=no and 1=yes that a >= 20% decrease of baseline systolic blood pressure was reported by the patient at least once during the placement to discharge time interval.|From placement in ED treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods.|||Emergency Department Visits|Emergency Department Visits||Count of Units
2595505|NCT02222246|Secondary|Incidence of Vomiting During Emergency Department Visits|Vomiting at any point from placement until discharge, based on vomiting data collected every 30 minutes during that time period. Thus, a vomiting variable was derived in which 0=no and 1=yes that vomiting was reported by the patient at least once during the placement to discharge time interval.|From placement in ED treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods.|||Emergency Department Visits|Emergency Department Visits||Count of Units
2595506|NCT02222246|Secondary|Incidence of Nausea During Emergency Department Visits|Nausea at any point from placement until discharge, based on nausea data collected every 30 minutes during that time period. Thus, a nausea variable was derived in which 0=no and 1=yes that nausea was reported by the patient at least once during the placement to discharge time interval.|From placement in Emergency Department (ED) treatment room to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods.|||Emergency Department Visits|Emergency Department Visits||Count of Units
2595507|NCT02222246|Secondary|Change in Pain Visual Analogue Scale (VAS) Scores Over Time|"Pain severity was assessed at arrival and every 30 minutes until discharge from the ED using a 100 mm visual analogue scale (VAS). The VAS range is 0 to 100 with 0 indicating no pain and 100 indicating pain as bad as it could be or worst imaginable pain. Discharge was defined by which one of the following occurred first: (a) decision to admit to hospital; (b) patient physically leaves the ED to home; or (c) after six hours of observation in the ED.~A hierarchical random coefficients regression model for repeated measurements (type of mixed hierarchical mixed-effect model) was conducted on the pain scores collected at six time points (arrival, post-placement 30-min, 60-min, 90-min,120-min, discharge) to evaluate the trajectory of change in pain. Discharge occurred at 120 minutes or later during each visit, with the exception of one discharge at 54 minutes."|Every 30 minutes from arrival in ED to discharge from the ED, up to 6 hours|The entire observation period was not evaluated because the patient-specific protocol has a shorter time to discharge, and, there was data missing at random after 120 minutes. To avoid a biased result, the mixed model was conducted on the data collected every 30 minutes during initial 120 minutes (2 hours) and at discharge.|||Units on a 100 mm VAS|Emergency Department Visits|Standard Deviation|Mean
2595508|NCT02222246|Primary|Difference in Pain Score as Measured by a Visual Analogue Scale (VAS)|"Each ED study visit was the unit of analysis for the statistical methods addressing the primary outcome. The primary outcome was change in pain score from arrival to discharge. Pain severity was assessed at arrival and discharge from ED using a 100 mm visual analogue scale (VAS). The VAS range is 0 to 100 with 0 indicating no pain and 100 indicating pain as bad as it could be or worst imaginable pain.Discharge was defined by which one of the following occurred first: (a) decision to admit to hospital; (b) patient physically leaves the ED to home; or (c) after six hours of observation in the ED. Thus, the difference in pain scores were calculated as the arrival minus discharge VAS scores, with higher positive pain difference or change scores indicating greater pain reduction."|Arrival in ED to discharge from the ED, up to 6 hours|Each Emergency Department study visit was the unit of analysis for the statistical methods addressing the primary outcome.|||Units on a 100 mm VAS|Emergency Department Visits|Standard Deviation|Mean
2595510|NCT02222207|Secondary|Percentage of Participants With Individual Changes in BCVA of Greater Than Equal to (>=) 0 Letters of Vision From Study Week 4 to Week 12 for Study Part A|Participants were assessed at each clinic visit for BCVA using the early treatment diabetic retinopathy study chart. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward.|Week 4, Week 12|Full Analysis Set (FAS): included subjects who received at least one dose of study medication.|||percentage of participants|||Number
2595511|NCT02222207|Primary|Change From Baseline in BCVA as Measured by ETDRS Letter Score at Study Week 12 for Study Part A|Participants were assessed at each clinic visit for best corrected visual acuity using the early treatment diabetic retinopathy study chart. Visual function of the study eye and the fellow eye was assessed using the ETDRS protocol. ETDRS testing score was recorded in the appropriate eCRF page at each study visit. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward. A higher score represents better functioning.|Baseline, Week 12|Full Analysis Set (FAS): included subjects who received at least one dose of study medication.|||Score on scale||Standard Deviation|Mean
2595512|NCT02222207|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Study Week 4 for Study Part A|Participants will be assessed at each clinic visit for best corrected visual acuity using the early treatment diabetic retinopathy study chart. Visual function of the study eye and the fellow eye was assessed using the ETDRS. The participant's ETDRS testing score was recorded in the appropriate eCRF page at each study visit. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward. A higher score represents better functioning.|Baseline, Week 4|Full Analysis Set (FAS): included participants who received at least one dose of study medication.|||Score on scale||Standard Deviation|Mean
2595513|NCT02222181|Secondary|Diastolic Blood Pressure|Diastolic pressure <90 mmHg|weekly||||mmHg||Standard Deviation|Mean
2595514|NCT02222181|Secondary|Glycemia|Normal levels: 70-99mg/dL; diabetic: >121mg/dL.|two months||||mg/dL||Standard Deviation|Mean
2595515|NCT02222181|Secondary|Triglycerides|Normal level: 150mg/dL|three months||||mg/dL||Standard Deviation|Mean
2595516|NCT02222181|Secondary|Total Cholesterol|Total Cholesterol <200 mg/dL|Total Cholesterol||||mg/dL||Standard Deviation|Mean
2595517|NCT02222181|Secondary|Systolic Blood Pressure|Systolic pressure <140 mmHg|weekly||||mmHg||Standard Deviation|Mean
2595518|NCT02222181|Primary|Clinical Dementia Rating (CDR)|CDR: scale 1-3 (0-0.5: normal aging; 1- initial stage; 2- middle stage; 3- final stage)|six months||||score||Standard Deviation|Mean
2595519|NCT02222181|Primary|Mini-mental State Examination (MMEE)|MMEE : scale 0-30 ( ≥25 - normal aging; 21-24 - initial stage; 20-10 - middle stage; ≤9 - final stage)|six months||||score||Standard Deviation|Mean
2595520|NCT02222129|Secondary|Time to First Opioid Use.|Time to first opioid use.|All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.|||||||
2595521|NCT02222129|Secondary|Length of Hospital Stay.|Length of hospital stay.|All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.|||||||
2595522|NCT02222129|Secondary|Visual Analog Pain Scores.|Visual analog pain scores.|All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.|||||||
2595523|NCT02222129|Primary|Total Opioid Consumption Measured in Intravenous Morphine Equivalents During the Postoperative Hospital Stay|Total opioid consumption measured in intravenous morphine equivalents during the postoperative hospital stay|All data was recorded during the patient's hospital stay, typically less than 5 days. All data was tabulated from the electronic medical record, typically within 30 days of discharge from hospital.||||mg (morphine equivalents)||Inter-Quartile Range|Median
2595524|NCT02221947|Other Pre-specified|Pharmacokinetic Parameters of Bryostatin.|Preliminary evaluation of pharmacokinetics and pharmacodynamics (Cmax, Tmax, AUClast).|Bryostatin plasma concentration pre-dose and at 15 min, 30 min, 1 hr, 1.5 hr, 2hr, 3hr and 6rs post dose.|Subjects who received a single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour (PK population)|||bryostatin plasma concentration (ng/mL)||Standard Deviation|Mean
2595525|NCT02221947|Secondary|Preliminary Efficacy of a Single Dose of Bryostatin in the Treatment of Patients With AD|"HVLT-R (Hopkins Verbal Learning Test-Revised™) delayed recall (change from baseline). A 12-item word list: 3 learning trials. Score range = 0-12. The lower the number, the more impaired.~Repeatable Battery of Assessments for Neuropsychological Status (RBANS) figure recall; change from baseline. Score Range: 0-20. The lower the number, the more impaired. Digit Symbol Coding (observed), Score range: 0-125. The lower the number, the more impaired.~Clinical Dementia Rating- Sum of Boxes (CDR-SB, observed). Sum of 6 investigated domains (Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, Personal Care). Each subtest range is 0-3; Sum of all 6 subtest scores gives total CDR-SB score (range= 0-18).The higher the number, the more impaired.~Mini Mental State Exam, version 2 (MMSE-2), change from baseline. The MMSE-2 measures aspects of cognitionon a scale of 0-30. Lower scores indicate greater cognitive impairment."|Specified timepoints within 2 weeks post study drug infusion||||units on a scale||Standard Deviation|Mean
2595526|NCT02221947|Primary|Preliminary Efficacy of a Single Dose of Bryostatin in the Treatment of Patients With AD|"Hopkins Verbal Learning Test - Revised (HVLT-R) delayed recall; change from baseline. HVLT consists of a 12-item word list drawn from 3 semantic categories, presented in 3 learning trials. Score range = 0-12. The lower the number, the more impaired.~Repeatable Battery of Assessments for Neuropsychological Status (RBANS) figure recall; change from baseline. Total Score Range: 0-20. Each portion of the drawing is scored 1 point for correctness and completeness and 1 point for being placed properly in relation to the rest of the drawing. Drawing and placement scores are summed for the item total. To obtain subtest total score, the drawing and placement scores are summed for each item. The lower the number, the more impaired."|48 hours post start of study drug infusion||||units on a scale, change from baseline||Standard Deviation|Mean
2596908|NCT02203578|Primary|Incidence of cGVHD||At 1 month after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.||||||
2595529|NCT02221882|Secondary|Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 MET Specific ELISA Assay|"Area under the serum concentration-time curve of LY3164530 over the dosing interval (AUC[0-τ]) from time 0 to 336 hours (τ) [Schedule 1] or from time 0-168 hours (τ) [Schedule 2].~Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion.~PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion."|Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)|All participants who received at least one dose of study drug and had evaluable PK data.|||µg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2595530|NCT02221882|Secondary|Area Under the Serum Concentration-Time Curve (AUC[0-τ]) of LY3164530 EGFR Specific ELISA Assay|"Area under the serum concentration-time curve of LY3164530 over the dosing interval (AUC[0-τ]) from time 0 to 336 hours (τ) [Schedule 1] or from time 0-168 hours (τ) [Schedule 2].~Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion.~PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion."|Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)|All participants who received at least one dose of study drug and had evaluable PK data.|||micrograms*milliliter per hour(µg*mL/hr)||Geometric Coefficient of Variation|Geometric Mean
2595531|NCT02221882|Secondary|Maximum Serum Concentration (Cmax) of LY3164530 Mesenchymal-Epithelial Transition Factor (MET) Specific ELISA Assay|"Cmax in Schedule 1 Cycles 1 and 2 and Schedule 2 Cycles 1 and 2 based on the MET-specific ELISA assay.~Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion.~PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion."|Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)|All participants who received at least one dose of study drug and had evaluable PK data.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2595532|NCT02221882|Secondary|Maximum Serum Concentration (Cmax) of LY3164530 Epidermal Growth Factor Receptor (EGFR) Specific ELISA Assay|"Cmax in Schedule (Sched) 1 Cycle 1 (C1) and Cycle 2 (C2) and Sched. 2 C1 and C2 dose escalation based on EGFR specific ELISA assay.~Pharmacokinetic (PK) Time Frame Schedule 1:Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2 hours (hrs), 4hrs, 6hrs, 24 ±4hrs post-infusion; Day 3: anytime during day; Day 8 ±1 : anytime during day. Day 15: Pre-dose, End of infusion; 2hrs, 4hrs, 6hrs post-infusion; Day 22 ±2: anytime during day. Cycles 3-6: Pre-dose, End of infusion.~PK Time Frame: Schedule 2: Cycle 1 and 2 (Day 1): Predose; Mid-infusion; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 3: anytime during day; Day 8: Pre-dose; End of infusion; Day 22: Pre-dose; End of infusion; 2hrs, 4hrs, 6hrs, 24 ±4hrs post-infusion (Cycle 1); Day 24: anytime during day. Cycles 3-6: Pre-dose; End of Infusion."|Cycle 1 predose (Day 1) up to Cycle 6 end of infusion (Day 1)|All participants who received at least one dose of study drug and had evaluable PK data.|||microgram per milliliter (µg/mL )||Geometric Coefficient of Variation|Geometric Mean
2595533|NCT02221882|Primary|Recommended Phase 2 Dose of LY3164530: Maximum Tolerated Dose (MTD)|Recommended Phase 2 Dose of LY3164530: MTD|Cycle 1 (Cycle = 28 days)|All participants who receive at least one dose of study drug.|||milligrams (mg)|||Number
2595534|NCT02221869|Secondary|Change in Quality of Life (QoL; SF-10 Physical and Psychosocial Summary Score) From the End of the Stable Dose Period to the End of the Double-blind Treatment Period|"The SF-10 Health Survey for Children is a parent-completed survey that contains 10 questions adapted from the Child Health Questionnaire. The SF-10 is intended to produce physical and psychosocial health summary measures. Each of the 10 questions responses is scored with a point value from 1 to 6 (1 is the worst possible condition and 6 is the best possible condition). The SF-10 physical and psychosocial measures are scored such that higher scores indicate more favorable functioning.~The questions and associated point values are separated into the Physical Health (PHS-10 domain) and Psychosocial Health (PSS-10 domain). The sums of the scores in each domain are standardized using the mean and standard deviation from a normal population (2006 sample). The standardized scores are transformed to norm based scoring (NBS) metric. Through NBS, scale scores are standardized to a mean of 50 and SD of 10 in the combined U.S. general population and clinical samples. NBS scores are reported"|From the end of the Stable Dose Period to the end of the Double-blind Treatment Period (2 weeks)||||score on a scale||Inter-Quartile Range|Median
2595535|NCT02221869|Secondary|CGIc for Narcolepsy Overall|"CGIc for narcolepsy overall from the end of the Stable Dose Period to the end of the Double-blind Treatment Period.~The CGIc is a 7-point scale ranging from very much improved to very much worse. A score of 0 = no change, a score of 3 = very much improved, and a score of -3 = very much worse."|From the end of the Stable Dose Period to the end of the Double-blind Treatment Period (2 weeks)||||score on a scale||Standard Deviation|Mean
2595536|NCT02221869|Secondary|Change in the Epworth Sleepiness Scale (ESS) (CHAD) Score|"Change in the ESS (CHAD) score from the end of the Stable Dose Period to the end of the Double-blind Treatment Period.~The ESS is a self-administered questionnaire with 8 questions. It provides a measure of a person's general level of daytime sleepiness, or their average sleep propensity in daily life. In the ESS for children and adolescents (CHAD), certain activities were modified. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness."|From the end of the Stable Dose Period to the end of the Double-blind Treatment Period (2 weeks)||||score on a scale||Inter-Quartile Range|Median
2595537|NCT02221869|Secondary|Clinical Global Impression of Change (CGIc) for Cataplexy Severity|"CGIc for cataplexy severity from the end of the Stable Dose Period to the end of the Double-blind Treatment Period.~The CGIc is a 7-point scale ranging from very much improved to very much worse. A score of 0 = no change, a score of 3 = very much improved, and a score of -3 = very much worse."|From the end of the Stable Dose Period to the end of the Double-blind Treatment Period (2 weeks)||||score on a scale||Standard Deviation|Mean
2595538|NCT02221869|Primary|Change in Weekly Number of Cataplexy Attacks|Double-blind comparison of the change in weekly number of cataplexy attacks from the last 2 weeks of the Stable Dose Period to the 2 weeks of the Double-blind Treatment Period.|From the end of the Stable Dose Period to the end of the Double-blind Treatment Period (2 weeks)||||number of attacks||Inter-Quartile Range|Median
2595539|NCT02221739|Secondary|Number pf Patients With Objective Radioactive Responses to Measure the Effects of RT and Anti-CTLA-4 mAb on Development of Anti-tumor Immunity Measured by T Cell Clone Frequency|The study uses a comprehensive approach to analyze immunological changes that reflect both local and systemic responses, and investigate both general immune activation as well as tumor antigen-specific T- and B-cell responses. The activity of anti-CTLA-1 mAb is thought to be mainly dependent on modulating the quantity and quality of T-cells in cancer patients. A highly extensive analysis of the Cluster of differentiation 4 + (CD4+) and cluster of differentiation 8 + (CD8+) T-cell subsets will be characterized by multi-color flow Cytometry. To facilitate these analyses, serial blood samples will be collected for serum and peripheral blood mononuclear cells (PBMC) at different time points, where, a part of these samples will be used for DNA/RNA extraction. Optional tissue biopsies will be obtained from consenting patients.Tumor tissue will be tested for expression of seven antigens frequently expressed in NSCLC.|3 weeks - 6 months post-treatment||||Participants|||Count of Participants
2595540|NCT02221739|Primary|Therapeutic Efficacy of Anti-CTLA-4 mAb and Concurrent Local RT in NSCLC Patients With Metastatic Disease.|Tumor Response will be evaluated using the irRC best response (Partial Response (PR) + Complete Response (CR)). Modified WHO criteria will be used for measurement of tumors. The irradiated lesion will be excluded from the assessment of response.|3 weeks - 6 months post treatment||||Participants|||Count of Participants
2595541|NCT02221674|Other Pre-specified|Change From Baseline (Visit 1, After Surgery) in Pain Intensity|"The change from baseline in pain intensity using the Face, Legs, Activity, Cry, Consolability Scale (FLACC Scale) at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 15 hours after a single dose of tapentadol.~The FLACC Scale is a behavioral scale for scoring postoperative pain in young children. It includes five categories of pain behaviors, including facial expression, leg movement, activity, cry, and consolability. The scale is scored in a range of 0-10 with 0 representing no pain.~The pain intensity scores were summarized descriptively per scheduled time point."|Baseline; up to 15 hours after study medication|"For the Arm/Group Participants aged 6 months to less than 2 years only 7 values were available at the timepoint 6 hours after administration."|||units on a scale||Standard Deviation|Mean
2595542|NCT02221674|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Participants Aged From Birth to Less Than 1 Month|"The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.~Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.~Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of tapentadol-O-glucuronide were calculated.~Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ).~If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A."|Up to 8 hours after IMP|The trial used sparse sampling for the assessment of Pharmacokinetic. Overall, there were 6 time points for sampling. Participants were allocated to 2 different time points for a blood sample to be taken. Some participants only had one sample taken. Some samples were below the Lower limit of quantification (LLOQ).|||nanogram per milliliter||Standard Deviation|Mean
2595543|NCT02221674|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Participants Aged 1 Month to Less Than 6 Months|"The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.~Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.~Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of tapentadol-O-glucuronide were calculated.~Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ).~If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A."|Up to 8 hours after IMP|The trial used sparse sampling for the assessment of Pharmacokinetic. Overall, there were 6 time points for sampling. Participants were allocated to 2 different time points for a blood sample to be taken. Some participants only had one sample taken. Some samples were below the Lower limit of quantification (LLOQ).|||nanogram per milliliter||Standard Deviation|Mean
2595544|NCT02221674|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Participants Aged 6 Months to Less Than 2 Years|"The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.~Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.~Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of tapentadol-O-glucuronide were calculated.~Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ).~If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A."|Up to 8 hours after IMP|The trial used sparse sampling for the assessment of Pharmacokinetic. Overall, there were 6 time points for sampling. Participants were allocated to 2 different time points for a blood sample to be taken. Some participants only had one sample taken. Some samples were below the Lower limit of quantification (LLOQ).|||nanogram per milliliter||Standard Deviation|Mean
2595545|NCT02221674|Primary|Pharmacokinetic Evaluation Based on Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Participants Aged From Birth to Less Than 1 Month|"The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.~Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.~Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of Tapentadol were calculated.~Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ).~If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A."|Up to 8 hours after IMP|The trial used sparse sampling for the assessment of Pharmacokinetic. Overall, there were 6 time points for sampling. Participants were allocated to 2 different time points for a blood sample to be taken. Some participants only had one sample taken. Some samples were below the Lower limit of quantification (LLOQ).|||nanogram per milliliter||Standard Deviation|Mean
2595546|NCT02221674|Primary|Pharmacokinetic Evaluation Based on Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Participants Aged 1 Month to Less Than 6 Months|"The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.~Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.~Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of Tapentadol were calculated.~Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ).~If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A."|Up to 8 hours after IMP administration|The trial used sparse sampling for the assessment of Pharmacokinetic. Overall, there were 6 time points for sampling. Participants were allocated to 2 different time points for a blood sample to be taken. Some participants only had one sample taken. Some samples were below the Lower limit of quantification (LLOQ).|||nanogram per milliliter||Standard Deviation|Mean
2595547|NCT02221674|Primary|Pharmacokinetic Evaluation Based on Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Participants Aged 6 Months to Less Than 2 Years|"The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.~Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.~Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of Tapentadol were calculated.~Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quantification (LLOQ).~If overall only a single sample was available at one of the pre-defined time points, the measured value is presented and the standard deviation is given as N/A."|Up to 8 hours after IMP administration|The trial used sparse sampling for the assessment of Pharmacokinetic. Overall, there were 6 time points for sampling. Participants were allocated to 2 different time points for a blood sample to be taken. Some participants only had one sample taken. Some samples were below the Lower limit of quantification (LLOQ).|||nanogram per milliliter||Standard Deviation|Mean
2595548|NCT02221648|Secondary|Number of Subjects Showing Improvement on Quality of Life Scale for Pain|The Quality of Life Scale: A Measure of Function for People With Pain was developed by the American Chronic Pain Association (ACPA). The patient is asked to rank their quality of life on a scale of zero (non-functioning) to 10 (normal quality of life). Improvement was defined as 2 or more grades of improvement on the scale.|6 weeks||||participants|||Number
2595549|NCT02221648|Secondary|Number of Patients With Improved Pain Using the Patient Global Impression of Change (PGIC)|"The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:~No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)~This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment"|6 weeks||||participants|||Number
2595550|NCT02221648|Primary|Proportion of Participants With Mild or no Pain on Visual Analog Scale (VAS)|"The primary outcome measure in this protocol is the proportion of subjects that have VAS <4 (patients with no or mild pain) at week 6. The pain VAS is a continuous scale comprised of a line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is anchored by no pain (score of 0) and worst imaginable pain (score of 10)."|6 weeks||||participants|||Number
2595551|NCT02221557|Primary|Percentage Change in Radiographic Measurement of Alveolar Ridge Height|Radiographic measurement was taken at most-middle portion of the grafted site, perpendicular to the line drawn from reference point (e.g. adjacent tooth/teeth Cement-Enamel Junction (CEJ) or margin of the restoration).|Change from baseline to 6 months||||percentage of change||Standard Deviation|Mean
2595552|NCT02221284|Secondary|Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment of Beta-cell Function [HOMA-β])|The reported data were change from baseline in HOMA-β. HOMA-β measures as following; HOMA-β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}.|Baseline, and final assessment point (up to Month 12)|Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.|||Percentage of beta cell function||Standard Deviation|Mean
2595574|NCT02221037|Secondary|Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance|Single 12-lead ECGs were obtained thereafter during the study, using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, RR and corrected QT (QTc) intervals. Number of participants with ECG values of potential clinical importance are presented.|Days 1, 2, 4 and 8|Safety Population.|||Participants|||Number
2595553|NCT02221284|Secondary|Change From Baseline in Laboratory Test Values (Homeostasis Model Assessment Ratio [HOMA-R])|The reported data were change from baseline in HOMA-R. HOMA-R measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405). A higher score indicates higher insulin resistance.|Baseline, and final assessment point (up to Month 12)|Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.|||HOMA-R Score||Standard Deviation|Mean
2595554|NCT02221284|Secondary|Change From Baseline in Laboratory Test Values (Fasting Insulin Level)|The reported data were change from baseline in fasting insulin level.|Baseline, and final assessment point (up to Month 12)|Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.|||Micro Units per Milliliter (μU/mL)||Standard Deviation|Mean
2595555|NCT02221284|Secondary|Change From Baseline in Laboratory Test Values (Fasting Blood Glucose Level)|The reported data were change from baseline in fasting blood glucose level.|Baseline, and final assessment point (up to Month 12)|Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.|||Milligram (mg)/deciliter (dL)||Standard Deviation|Mean
2595556|NCT02221284|Secondary|Number of Participants Achieving Specified HbA1c Level (< 7.0% and <6.0%)|The reported data were number of participants who achieved specified HbA1c Level (< 7.0% and <6.0%) during this study.|Baseline, and final assessment point (up to Month 12)|Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.|||Participants|||Count of Participants
2595557|NCT02221284|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final assessment point (up to Month 12) relative to baseline.|Baseline, and final assessment point (up to Month 12)|Efficacy assessment population was defined as participants who completed study and had available efficacy data at baseline and post baseline. Efficacy analysis was planned to be assessed in Alogliptin + Insulin, Alogliptin + Glinide and Alogliptin + SGLT-2 inhibitor groups and data for Alogliptin + Other were not collected as specified in protocol.|||Percent||Standard Deviation|Mean
2595558|NCT02221284|Primary|Percentage of Participants Who Had One or More Adverse Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Up to Month 12|Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.|||Percentage of Participants|||Number
2595559|NCT02221037|Secondary|BAL Concentrations of GSK2862277|BAL samples were collected on Day 1 (on completion of surgery) and BAL concentrations of GSK2862277 and derived PK parameters were determined. Only those participants available at the specified time points were analyzed.|Day 1 (on completion of surgery)|PK Population.|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2595560|NCT02221037|Secondary|Number of Participants With Positive Immunogenicity Results Post-dosing|Serum samples were obtained to determine incidence and titers of serum anti-GSK2862277 antibodies at the specified time points. The binding antibody detection assay was performed at the specified time points. Number of participants with positive immunogenicity results post-dosing is presented.|Day 8 and Day 31|Safety Population.|||Participants|||Number
2595561|NCT02221037|Secondary|Ratio of Total Protein Derived From BAL and Plasma Values|BAL sampling and plasma sampling was done on Day 1 (on completion of surgery). Raw summary statistics for the derived ratio were not produced. Only statistical modeling was performed that produced a posterior distribution for each treatment. Summary measure for the posterior distribution was the median. The quantity being modeled was the mean treatment effect (pooling data from BAL Collapsed and Ventilated Lungs). The standard deviation is capturing the dispersion of the estimate for the mean effect. Ratio of total protein (Ratio was derived from BAL and Plasma values) is presented.|Day 1 (on completion of surgery)|PP1 Population.|||Ratio||Standard Deviation|Median
2595562|NCT02221037|Secondary|Derived Pharmacokinetic Parameter- Half-life (t1/2) and Time of Occurrence of Cmax (Tmax)|Half-life (t1⁄2) is the time required for a quantity to reduce to half its initial value. t1/2 was not determined in all cases due to insufficient data in the terminal phase. Blood samples for pharmacokinetic analysis of GSK2862277 were collected at the indicated time points. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.|Day 1 (pre-dose, 1 hour post-dose and on completion of surgery), Day 2 (24 to 26 hours post-dose) and Day 3 (46 to 50 hours post-dose)|PK Population.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2595563|NCT02221037|Secondary|Maximum Observed Concentration (Cmax)|Blood samples for pharmacokinetic analysis of GSK2862277 were collected at the indicated time points.|Day 1 (pre-dose, 1 hour post-dose and on completion of surgery), Day 2 (24 to 26 hours post-dose) and Day 3 (46 to 50 hours post-dose)|PK Population.|||Picograms per milliliters||Geometric Coefficient of Variation|Geometric Mean
2595564|NCT02221037|Secondary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0 to t])|Blood samples for pharmacokinetic analysis of GSK2862277 were collected at the indicated time points. Pharmacokinetic (PK) Population comprised of all participants in the Safety population for whom a pharmacokinetic sample (plasma and/or BAL) was obtained and analyzed.|Day 1 (pre-dose, 1 hour post-dose and on completion of surgery), Day 2 (24 to 26 hours post-dose) and Day 3 (46 to 50 hours post-dose)|PK Population.|||Hours*picograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2595565|NCT02221037|Secondary|Daily Sequential Organ Failure Assessment (SOFA) Scores on Day 2 Through to Day 4|"The SOFA score defines the presence and severity of dysfunction within 6 organ systems (cardiovascular, respiratory, coagulation, liver, renal, and nervous system) with a value of 0 for assigned to normal function to a maximum value of 4 for severe dysfunction in each of the organ systems. Each component of the SOFA score was added together, ranging from 0 indicating no organ dysfunction in any of the 6 organ systems, to 24 indicating maximal organ dysfunction across all 6 organ systems. Per-Protocol (PP) 2 Population comprised of all the participants in the Safety population for whom the study drug actually received was the same one they were randomized to (study drug)."|Day 2 to Day 4|PP 2 Population.|||Scores on a Scale||Standard Deviation|Mean
2595566|NCT02221037|Secondary|Change Over Time in EVLWI Post-operatively on Day 2 Through to Day 4|EVLW refers to the fluid within the lung but outside the vascular compartment. It includes extravasated plasma, intracellular water, lymphatic fluid, and surfactant. EVLWI was measured by trans-pulmonary thermodilution via a PiCCO hemodynamic monitor. Change from Baseline value was the post-Baseline value minus Baseline value. PP1 Population was analyzed. Only those participants available at the specified time points were analyzed represented by n=X,X,X,X in the category titles.|Baseline (Day 1 [immediately prior to start of surgery]) to Days 2, 3 and 4|PP1 Population.|||Millimeters per kilograms||Standard Deviation|Mean
2595567|NCT02221037|Secondary|Change Over Time in PVPI Post-operatively on Day 2 Through to Day 4|PVPI is a derived value from EVLW, and is considered to be less variable than EVLWI. PVPI was measured via single-indicator transpulmonary thermodilution as long as the participant remained in the ICU with a patent indwelling PiCCO catheter. Baseline was Day 1 (immediately prior to start of surgery). Change from Baseline value was the post-Baseline value minus Baseline value. PP1 Population was analyzed. Only those participants available at the specified time points were analyzed represented by n=X,X,X,X in the category titles.|Baseline (Day 1 [immediately prior to start of surgery]) to Days 2, 3 and 4|PP1 Population.|||Ratio||Standard Deviation|Mean
2595568|NCT02221037|Secondary|Change Over Time in PaO2/FiO2 Post-operatively on Day 2 Through to Day 4|Oxygenation and function of gas exchange was assessed by the comparison of PaO2 divided by the FiO2, sometimes referred to simply as the 'P to F ratio'. The P to F ratio was assessed at time points during the period of intubation and mechanical ventilation. An arterial blood sample was required for determination of the partial pressure of oxygen and the percentage of O2 which is being inspired was recorded at the corresponding time point. Baseline was Day 1 (immediately prior to start of surgery). Change from Baseline value was the post-Baseline value (on completion of surgery on Day 1) minus Baseline value. PP1 Population was analyzed. Only those participants available at the specified time points were analyzed represented by n=X,X in the category titles.|Baseline (Day 1 [immediately prior to start of surgery]) to Days 2, 3 and 4|PP1 Population.|||Millimeters of Mercury||Standard Deviation|Mean
2595569|NCT02221037|Secondary|Levels of BAL Biomarkers (Surfactant Protein and Clara Cell Secretory Protein) on Completion of Surgery|Samples were collected to determine concentrations of biomarkers in BAL using an appropriately validated assay. BAL biomarkers included surfactant protein D and clara cell secretory protein. Any value below limit of quantification was replaced with half the LLQ prior to deriving the summary measures. Mean levels of BAL biomarkers on completion of surgery are presented. Only those participants available at the specified time points were analyzed represented by n=X,X,X,X in the category titles.|Day 1 (on completion of surgery)|PP1 Population.|||Nanograms per milliliter||Standard Deviation|Mean
2595570|NCT02221037|Secondary|Levels of BAL Biomarkers (C-reactive Protein and Total Proteins) on Completion of Surgery|Samples were collected to determine concentrations of biomarkers in BAL using an appropriately validated assay. BAL biomarkers included C-reactive protein and total proteins. Any value below limit of quantification was replaced with half the LLQ prior to deriving the summary measures. All BAL C-reactive protein samples were below limit of quantification and all were assigned to half the LLQ prior to deriving the summary measures. Mean levels of BAL biomarkers on completion of surgery are presented. Only those participants available at the specified time points were analyzed represented by n=X,X,X,X in the category titles.|Day 1 (on completion of surgery)|PP1 Population.|||Milligrams per Liter||Standard Deviation|Mean
2595571|NCT02221037|Secondary|Levels of BAL Biomarkers on Completion of Surgery|Samples were collected to determine concentrations of biomarkers in BAL using an appropriately validated assay on Day 1 after completion of surgery. BAL biomarkers included soluble tumor necrosis factor receptor (STNFR) type I, free, STNFR type I, total, tumor necrosis factor alpha, interleukin 6, interleukin 8, interleukin 1 beta, monocyte chemotactic protein-1, macrophage inflammatory protein 1 alpha, macrophage inflammatory protein 1 beta, interleukin 10 and soluble receptor for advanced glycation end (sRAGE) products. Any value below limit of quantification was replaced with half the lower limit of quantification (LLQ) prior to deriving the summary measures. Mean levels of BAL biomarkers on completion of surgery are presented. Only those participants available at the specified time points were analyzed represented by n=X,X,X,X in the category titles.|Day 1 (on completion of surgery)|PP1 Population.|||Picograms per milliliter||Standard Deviation|Mean
2595572|NCT02221037|Secondary|Baseline Adjusted Change in PaO2/FiO2 on Completion of Surgery|Oxygenation and function of gas exchange was assessed by the comparison of partial pressure of oxygen arterially (PaO2) divided by the fraction of oxygen that is being inspired (FiO2), sometimes referred to simply as the 'P to F ratio'. The P to F ratio was assessed at time points during the period of intubation and mechanical ventilation. An arterial blood sample was required for determination of the partial pressure of oxygen and the percentage of O2 which is being inspired was recorded at the corresponding time point. Baseline was Day 1 (immediately prior to start of surgery). Change from Baseline value was the post-Baseline value (on completion of surgery on Day 1) minus Baseline value.|Baseline (Day 1 [immediately prior to start of surgery]) and Day 1 (on completion of surgery)|PP1 Population.|||Millimiters of Mercury||Standard Deviation|Mean
2595573|NCT02221037|Secondary|Number of Participants With Vital Signs of Potential Clinical Importance|Vital sign measurements included systolic and diastolic blood pressure, pulse rate, temperature and respiratory rate. Vital sign measurements were measured in a semi-recumbent or supine position after 5 minutes rest. The potential clinical concern range for systolic blood pressure: <85 and >160 millimeters of mercury, for diastolic: <45 and >100 millimeters of mercury and heart rate: <40 and >110 beats per minute. Number of participants with vital signs of potential clinical importance are presented.|Up to Day 31|Safety Population.|||Participants|||Number
2595575|NCT02221037|Secondary|Number of Participants With Abnormal Urinalysis Parameters|Urinalysis included dipstick urine test which was used to screen for glucose, ketones, occult blood and protein on Day 1 (pre-dose) and Day 8. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters of urine glucose, ketones, occult blood and protein can be read as Trace, 1+, 2+ and 3+, indicating proportional concentrations in the urine sample.|Day 1 (pre-dose) and Day 8|Safety Population.|||Participants|||Number
2595576|NCT02221037|Secondary|Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance|Clinical chemistry parameters and their potential clinical concern values were: albumin (low: <25 millimole [mmol]/L and high: >60 mmol/L), calcium (low: <1.8 mmoL/L and high: >2.75 mmol/L), creatinine (low: <30 mmol/L and high: >160 mmol/L), glucose (low: <3 mmol/L and high: >9 mmol/L), potassium (low: <2.5 mmol/L and high: >5.5 mmol/L), sodium (low: <120 mmol/L and high: >160 mmol/L), total carbon dioxide content (low: <16 mmol/L and high: >35 mmol/L) and blood urea nitrogen (low: <3 mmol/L and high: >15 mmol/L). Number of participants with clinical chemistry abnormalities of potential clinical importance are presented.|Up to Day 8|Safety Population.|||Participants|||Number
2595577|NCT02221037|Secondary|Number of Participants With Hematology Abnormalities of Potential Clinical Importance|Hematology parameters included basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, monocytes, neutrophils, neutrophil bands, platelets, red blood cell (RBC) count, segmented neutrophils and white blood cell (WBC) count. The potential clinical concern values were: hematocrit (low: <0.3 fraction and high: >0.54 fraction), Hemoglobin (low: <90 gram per Liter and high: >180 gram per Liter), lymphocytes (low: <0.6 x 10^9 cells/Liter and high: >3.0 x 10^9 cells/Liter), neutrophils: (low: <1.5 x 10^9 cells/Liter and high: >20 x 10^9 cells/Liter), platelets: (low: <100 x 10^9 cells/Liter and high: >600 x 10^9 cells/Liter) and WBC: (low: <3 x 10^9 cells/Liter and high: >20 x 10^9 cells/Liter). Only those participants for which at least one value of potential clinical concern was reported are summarized.|Up to Day 8|Safety Population.|||Participants|||Number
2595578|NCT02221037|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product (MP), whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Safety Population comprised of all participants who received at least one complete dose of study treatment.|Up to Day 31|Safety Population.|||Participants|||Number
2595579|NCT02221037|Secondary|Baseline Adjusted Change in EVLWI on Completion of Surgery|EVLW refers to the fluid within the lung but outside the vascular compartment. It includes extravasated plasma, intracellular water, lymphatic fluid, and surfactant. EVLWI was measured by trans-pulmonary thermodilution via a PiCCO hemodynamic monitor. Baseline was Day 1 (immediately prior to start of surgery). Change from Baseline value was the post-Baseline value (on completion of surgery on Day 1) minus Baseline value. Only those participants with data available at the specified time points were analyzed.|Baseline (Day 1 [immediately prior to start of surgery]) and Day 1 (on completion of surgery)|PP1 Population.|||Milliliters per kilograms||Standard Deviation|Mean
2595580|NCT02221037|Primary|Baseline Adjusted Change in Pulmonary Vascular Permeability Index (PVPI) on Completion of Surgery|PVPI is a derived value from extra vascular lung water (EVLW), and is considered to be less variable than extra vascular lung water Index (EVLWI). PVPI was measured via single-indicator transpulmonary thermodilution with a patent indwelling Pulse Contour Cardiac Output (PiCCO) catheter. Baseline was Day 1 (immediately prior to start of surgery). Change from Baseline value was the post-Baseline value (on completion of surgery on Day 1) minus Baseline value. Per-Protocol 1 (PP1) Population comprised of all the participants in the Safety population for whom the treatment actually received was the same one when they were randomized to (both study drug and BAL sampling location).|Baseline (Day 1 [immediately prior to start of surgery]) and Day 1 (on completion of surgery)|PP1 Population.|||Ratio||Standard Deviation|Mean
2595581|NCT02220998|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2595582|NCT02220998|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12||Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2595583|NCT02220998|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12||Weeks 1, 2, 4, 6, 8, 10, and 12||||percentage of participants||95% Confidence Interval|Number
2595584|NCT02220998|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2595585|NCT02220998|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
2595586|NCT02220998|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants randomized or enrolled into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2595587|NCT02220920|Secondary|"Percentage of Participants With Adverse Events and Hypoglycemia and Blood Glucose Decreased"||Week 16|"Safety analysis set. Safety Population reflects the as treated population, and one Canagliflozin (TA-7284) + Insulin participant actually received Placebo + Insulin."|||percentage of participants|||Number
2595589|NCT02220920|Secondary|Percent Change in Body Weight||baseline and Week 16|"Full analysis set, last observation carried forward. There was a lack of measurement of body weight at the end of treatment visit(Week 4) in one participant who was randomized to Canagliflozin(TA-7284) + Insulin group."|||percent change||Standard Error|Least Squares Mean
2595590|NCT02220920|Secondary|Change in Fasting Plasma Glucose||baseline and Week 16|"Full analysis set, last observation carried forward. There was a lack of measurement of fasting plasma glucose at the end of treatment visit(Week 4) in one participant who was randomized to Canagliflozin(TA-7284) + Insulin group."|||mg/dL||Standard Error|Least Squares Mean
2595591|NCT02220920|Primary|Change in HbA1c From Baseline||baseline and Week 16|Full analysis set, last observation carried forward|||Percent||Standard Error|Least Squares Mean
2595592|NCT02220907|Secondary|Percentage Change in Body Weight From Baseline|The percentage change from baseline in body weight collected at Week 52.|Baseline, 52 Weeks|Full analysis set, last observation carried forward. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.|||percent change||Standard Deviation|Mean
2595593|NCT02220907|Secondary|Change From Baseline in Fasting Plasma Glucose Level|The change from baseline in fasting plasma glucose level collected at Week 52.|Baseline, 52 Weeks|Full analysis set, last observation carried forward. Outcome measure for one patient was not assessed at a certain timepoint due to dropout.|||mg/dL||Standard Deviation|Mean
2595594|NCT02220907|Secondary|Change From Baseline in Percentage of Glycated Hemoglobin (HbA1c)|The change from baseline in percentage of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 52.|Baseline, 52 Weeks|Full analysis set, last observation carried forward|||percentage of HbA1c||Standard Deviation|Mean
2595595|NCT02220907|Primary|Number of Participants With Adverse Events||52 Weeks||||participants|||Number
2595596|NCT02220894|Secondary|Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented. These safety results are based on a 26-February-2018 data cutoff date.|Through Database Cutoff Date of 26-Feb-2018 (up to approximately 38 months)|The analysis population consisted of all participants who received ≥1 dose of study treatment.|||Participants|||Count of Participants
2595597|NCT02220894|Secondary|Number of Participants Who Experienced At Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented. These safety results are based on a 26-February-2018 data cutoff date.|Through Database Cutoff Date of 26-Feb-2018 (up to approximately 38 months)|The analysis population consisted of all participants who received ≥1 dose of study treatment.|||Participants|||Count of Participants
2595598|NCT02220894|Secondary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥1%|ORR was determined for participants with a TPS of ≥1%. ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The efficacy hypothesis was analyzed using a sequential testing strategy that involved testing a hypothesis only if the superiority of pembrolizumab over chemotherapy was established for all the preceding hypotheses. The order of testing was ORR in participants with TPS≥50%, then with TPS≥20%, and finally with TPS≥1%. The percentage of participants who had a TPS ≥1% and who experienced a CR or PR is presented.|Through Database Cutoff Date of 26-Feb-2018 (up to approximately 38 months)|The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥1%.|||Percentage of participants||95% Confidence Interval|Number
2595599|NCT02220894|Secondary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥20%|ORR was determined for participants with a TPS of ≥20%. ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The efficacy hypothesis was analyzed using a sequential testing strategy that involved testing a hypothesis only if the superiority of pembrolizumab over chemotherapy was established for all the preceding hypotheses. The order of testing was ORR in participants with TPS≥50%, then with TPS≥20%, and finally with TPS≥1%. The percentage of participants who had a TPS ≥20% and who experienced a CR or PR is presented.|Through Database Cutoff Date of 26-Feb-2018 (up to approximately 38 months)|The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥20%.|||Percentage of participants||95% Confidence Interval|Number
2595667|NCT02219477|Secondary|Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Chld-Pugh Score|The The Child-Pugh score uses five clinical measures of liver disease (3 laboratory parameters and 2 clinical assessments) to measure severity of cirrhosis. Scores range from 5 to 15, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12.|Up to post-treatment Week 12|Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12.|||percentage of participants|||Number
2595600|NCT02220894|Secondary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥50%|ORR was determined for participants with a TPS of ≥50%. ORR was determined per RECIST 1.1 and was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The efficacy hypothesis was analyzed using a sequential testing strategy that involved testing a hypothesis only if the superiority of pembrolizumab over chemotherapy was established for all the preceding hypotheses. The order of testing was ORR in participants with TPS≥50%, then with TPS≥20%, and finally with TPS≥1%. The percentage of participants who had a TPS ≥50% and who experienced a CR or PR is presented.|Through Database Cutoff Date of 26-Feb-2018 (up to approximately 38 months)|The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥50%.|||Percentage of participants||95% Confidence Interval|Number
2595601|NCT02220894|Secondary|Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥1%|PFS was determined for participants with a TPS of ≥1% and was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The efficacy hypothesis was analyzed using a sequential testing strategy that involved testing a hypothesis only if the superiority of pembrolizumab over chemotherapy was established for all the preceding hypotheses. The order of testing was PFS in participants with TPS≥50%, then with TPS≥20%, and finally with TPS≥1%. The PFS for participants with a TPS ≥1% is presented.|Through Database Cutoff Date of 26-Feb-2018 (up to approximately 38 months)|The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥1%.|||Months||95% Confidence Interval|Median
2595602|NCT02220894|Secondary|Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥20%|PFS was determined for participants with a TPS of ≥20% and was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The efficacy hypothesis was analyzed using a sequential testing strategy that involved testing a hypothesis only if the superiority of pembrolizumab over chemotherapy was established for all the preceding hypotheses. The order of testing was PFS in participants with TPS≥50%, then with TPS≥20%, and finally with TPS≥1%. The PFS for participants with a TPS ≥20% is presented.|Through Database Cutoff Date of 26-Feb-2018 (up to approximately 38 months)|The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥20%.|||Months||95% Confidence Interval|Median
2595603|NCT02220894|Secondary|Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With a Tumor Proportion Score (TPS) of ≥50%|PFS was determined for participants with a TPS of ≥50% and was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The efficacy hypothesis was analyzed using a sequential testing strategy that involved testing a hypothesis only if the superiority of pembrolizumab over chemotherapy was established for all the preceding hypotheses. The order of testing was PFS in participants with TPS≥50%, then with TPS≥20%, and finally with TPS≥1%. The PFS for participants with a TPS ≥50% is presented.|Through Database Cutoff Date of 26-Feb-2018 (up to approximately 38 months)|The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥50%.|||Months||95% Confidence Interval|Median
2595604|NCT02220894|Primary|Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥1%|OS was determined for participants with a TPS of ≥1% and was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. The efficacy hypothesis was analyzed using a sequential testing strategy that involved testing a hypothesis only if the superiority of pembrolizumab over chemotherapy was established for all the preceding hypotheses. The order of testing was OS in participants with TPS≥50%, then with TPS≥20%, and finally with TPS≥1%. The OS for participants with a TPS ≥1% is presented.|Through Database Cutoff Date of 26-Feb-2018 (up to approximately 38 months)|The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥1%.|||Months||95% Confidence Interval|Median
2595623|NCT02219997|Secondary|Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF)|Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.|Visit 2, Up to Day 30|This analysis population is a subset of all randomized subjects with no major protocol violations and had non-missing values at the specific time point for each arm, respectively.|||seconds||Standard Deviation|Mean
2595605|NCT02220894|Primary|Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥20%|OS was determined for participants with a TPS of ≥20% and was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. The efficacy hypothesis was analyzed using a sequential testing strategy that involved testing a hypothesis only if the superiority of pembrolizumab over chemotherapy was established for all the preceding hypotheses. The order of testing was OS in participants with TPS≥50%, then with TPS≥20%, and finally with TPS≥1%. The OS for participants with a TPS ≥20% is presented.|Through Database Cutoff Date of 26-Feb-2018 (up to approximately 38 months)|The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥20%.|||Months||95% Confidence Interval|Median
2595606|NCT02220894|Primary|Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥50%|OS was determined for participants with a TPS of ≥50% and was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. The efficacy hypothesis was analyzed using a sequential testing strategy that involved testing a hypothesis only if the superiority of pembrolizumab over chemotherapy was established for all the preceding hypotheses. The order of testing was OS in participants with TPS≥50%, then with TPS≥20%, and finally with TPS≥1%. The OS for participants with a TPS ≥50% is presented.|Through Database Cutoff Date of 26-Feb-2018 (up to approximately 38 months)|The analysis population included all participants who were alive at the time of randomization and had a TPS of ≥50%.|||Months||95% Confidence Interval|Median
2595607|NCT02220855|Secondary|Overall Survival Rate|Duration of time from the start of treatment to time of death due to any causes. Patients who do not die will be censored on their last known alive date. Kaplan-Meier methods will be used and the median and 95% confidence intervals will be calculated.|up to three years|All patients enrolled and received treatment.|||months||95% Confidence Interval|Median
2595608|NCT02220855|Secondary|Percent of Patients Achieving Disease Control|Percent of patients achieving disease control and the Binomial Exact 95% confidence interval. Disease control is defined as having a best response of Complete Response (defined as disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10mm) or Partial Response (defined as at least a 30% decrease in the sum of diameters of target lesions from the baseline sum diameters) or Stable Disease for at least 4 months (defined by neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression) by RECIST v1.1 criteria.|up to three years|All patients enrolled and received treatment.|||percentage of participants||95% Confidence Interval|Number
2595609|NCT02220855|Secondary|Progression-free Survival Rate|Duration of time from the start of treatment to time of documented progression or death. Patients who do not progress or die will be censored on their last evaluation date. Kaplan-Meier methods will be used and the median and 95% confidence intervals will be calculated.|up to three years|All patients enrolled and received treatment.|||months||95% Confidence Interval|Median
2595610|NCT02220855|Secondary|Treatment Related Adverse Events Grade 3 or Above|Number of unique patients who had a treatment related (possible, probable or definite) adverse events with grade >= 3.|up to three years|All patients enrolled and received treatment.|||Participants|||Count of Participants
2595611|NCT02220855|Primary|Percent of Patients With Objective Response|Percent of patients with Objective response and the Binomial Exact 95% confidence interval. Objective response is defined as having a best response of Complete Response (defined as disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to <10mm) or Partial Response (defined as at least a 30% decrease in the sum of diameters of target lesions from the baseline sum diameters) by RECIST v1.1 criteria.|up to three years|All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit|||percentage of participants||95% Confidence Interval|Number
2595612|NCT02220764|Other Pre-specified|Number of of Fixed Dental Prostheses (FDPs) With Rough Surface|Measurement of the restorations with rough surface 6,12,18,24,30 and 36 months after placement of the restorations.|3 years||||FDPs with rough surface|||Number
2595613|NCT02220764|Secondary|Number of Fixed Dental Prostheses (FDPs) With Chip/s|Measurement of the amount of fractures of the veneering material 6,12,18,24,30 and 36 months after placement of the restorations. The percentage of chips for the implant- and tooth- supported restorations will be reported.|3 years||||FDPs with chip/s|||Number
2595614|NCT02220764|Primary|Number of Fixed Dental Prostheses (FDPs) With Failure|"Failure was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period."|3 years||||FDPs with failure|||Number
2595615|NCT02220725|Secondary|Efficacy: Number of Participants With Thrombin Generation (ETP) Above the Lower Limit of the Derived Normal Range at Its Peak (mITT Population)|Number of participants with ETP above the lower limit of the normal range at its peak, between the +2 minute time point and the +10 minute time point after the end of the andexanet bolus (inclusive) [Part I] or between the 110-minute time point (10 minutes prior to the end of the continuous infusion) and the 5-minute time point after the end of the continuous infusion (inclusive) [Part II]. ETP was measured using a tissue factor-initiated thrombin generation assay|Baseline to +2 minutes or +10 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II)|mITT; 41 and 39 subjects who received andexanet or placebo were included in the PD analysis in Part I and II, respectively.|||Participants|||Count of Participants
2595624|NCT02219997|Secondary|Change in Braking Reaction Time From No-glare to Glare (Clear IOLs)|Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare. This outcome measure was pre-specified for Clear IOL only.|Visit 2, Up to Day 30|This analysis population is a subset of all randomized subjects with no major protocol violations and had non-missing values at the specific time point for each arm, respectively.|||seconds||Standard Deviation|Mean
2595616|NCT02220725|Secondary|Efficacy: Change in Thrombin Generation (ETP) From Baseline to Its Peak [Parts I and II]|Change in ETP from baseline to its peak, where peak was defined as the largest value for ETP between the +2 minute time point and the +10 minute time point after the end of the andexanet bolus (inclusive) {Part I] or between the 110-minute time point (10 minutes prior to the end of the continuous infusion) and the 5-minute time point after the end of the continuous infusion (inclusive) [Part II]. Baseline was the last assessment obtained prior to the first dose of andexanet or placebo. ETP was measured using a tissue factor-initiated thrombin generation assay.|Baseline to +2 minutes or +10 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II)|mITT; 41 and 39 subjects who received andexanet or placebo were included in the PD analysis in Part I and II, respectively.|||nmol/min||Standard Deviation|Mean
2595617|NCT02220725|Secondary|Efficacy: Change From Baseline in Free Rivaroxaban Concentration at the Nadir|Change from baseline in free rivaroxaban concentration (ng/mL) at the nadir, when nadir was defined as the smaller value for free rivaroxaban at the +2 minute or +5 minute time point after the completion of the andexanet bolus (Part I) or between the 110-minute time point (10 minutes prior to the end of the continuous infusion) and the 5-minute time point after the end of the continuous infusion (inclusive) [Part II]. Free plasma concentrations of rivaroxaban was determined using a validated method that involved analysis of citrated human plasma with high-throughput equilibrium dialysis followed by liquid chromatography mass spectrometry.|Baseline to +2 minutes or +5 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II)|54 subjects who received rivaroxaban were included in the rivaroxaban pharmacokinetics (PK) analysis|||ng/mL||Standard Deviation|Mean
2595618|NCT02220725|Secondary|Efficacy: Number of Participants With ≥80% Reduction in the Anti-fXa Activity From Baseline to Nadir|Number of participants with ≥80% reduction in anti-fXa activity from its baseline to nadir, when nadir was defined as the smaller value for anti-fXa activity at the +2 minute or +5 minute time point after the completion of the andexanet bolus (Part I) or between the 110-minute time point (10 minutes prior to the end of the continuous infusion) and the 5-minute time point after the end of the continuous infusion (inclusive) {Part II]. Baseline was the last assessment obtained prior to the first dose of andexanet or placebo|Baseline to +2 minutes or +5 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II)|mITT; 41 and 39 subjects who received andexanet or placebo were included in the PD analysis in Part I and II, respectively.|||Participants|||Count of Participants
2595619|NCT02220725|Secondary|Efficacy: Percent Change in Anti-fXa Activity (Part II)|The percent change from baseline in anti-fXa activity at the nadir, following the bolus, when nadir was defined as the smaller value for anti-fXa activity at the +2 minute or +5 minute time point after the completion of the andexanet bolus (Part II). Baseline was the last assessment obtained prior to the first dose of andexanet or placebo|Baseline to +2 minutes or +5 minutes following the end of andexanet/placebo bolus (Part II)|mITT; 41 and 39 subjects who received andexanet or placebo were included in the pharmacodynamics (PD) analysis in Part I and II, respectively.|||Percent change in anti-fXa activity||Standard Deviation|Mean
2595620|NCT02220725|Primary|Efficacy: Percent Change From Baseline in Anti-fXa Activity at the Nadir (Parts I and II)|In Part 1, the primary endpoint was percent change from baseline in anti-fXa activity at the nadir, when nadir was defined as the smaller value for anti-fXa activity at the +2 minutes or +5 minutes time point following the end of the bolus. In Part 2, the primary endpoint was the percent change from baseline in anti-fXa activity from its baseline to nadir, when nadir was defined as the smaller value for anti-fXa activity between the 110-minute time point (10 minutes prior to the end of the continuous infusion) and the 5-minute time point after the end of the continuous infusion. The baseline for the primary endpoint in both parts was the anti-fXa activity just prior to administration of andexanet, 4 hours following the Day 4 dose of rivaroxaban. Anti-fXa activity was measured by a modified chromogenic assay.|Baseline to +2 minutes or +5 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II)|Modified Intent-to-Treat Population included all subjects receiving andexanet/placebo with anti-fXa activity baseline value at ≥1 timepoints: 2 or 5 minute after the end of the bolus (Part I; N = 41); 110 minute during continuous infusion, 2 minute before or 5 minute after the end of continuous infusion (Part II; N = 39).|||Percent change in anti-fXa activity||Standard Deviation|Mean
2595621|NCT02220205|Secondary|Percent Change in Comfort Placing IUDs From Pre- to Post-insertion|Participants were given questionnaires at the initial study visit and at a three-month follow-up visit that assessed their comfort with IUD insertion using a modified Likert scale.|Baseline to three months||||Percent change in comfort|||Number
2595622|NCT02220205|Primary|Insertion Score Before and Immediately After Initial Practice (Same Day), and 3 Months After Initial Practice|"Participants were filmed performing 3 IUD insertions each, for three IUDs available in the US. They then practiced on an assigned simulator for 30 minutes, and were re-recorded immediately afterwards. Three months after initial practice, they returned and performed the insertions again.~Sets of insertions were scored using a checklist. Participants earned up to 86 points for performing various elements of IUC insertion correctly: sounding the uterus (14 points), and loading as well as inserting the copper device (24 points), levonorgestrel 52mg device (26 points), and levonorgestrel 13.5mg device (22 points). Higher scores were better."|Before and immediately after initial practice on assigned simulator (same day), and three months after initial practice||||Percent of tasks performed correctly||Inter-Quartile Range|Median
2595625|NCT02219997|Primary|Change in Braking Reaction Time From No-glare to Glare|Braking reaction time (time to brake, in seconds) was assessed using a driving simulator in no-glare and glare conditions. The subject was presented with a driving scenario during which an obstruction (car pulling over from either side of the road in a random fashion) was presented. Subjects braked in an attempt to avoid colliding with the obstruction, and the braking reaction time was recorded. The experiment was repeated with a glare source present. Both assessments (no-glare and glare) occurred on the same day. Change in braking reaction time was calculated as glare minus no-glare.|Visit 2, up to Day 30|This analysis population includes subjects who were reaction tested with no major protocol violations (per protocol).|||seconds||Standard Deviation|Mean
2595626|NCT02219932|Secondary|Change From Baseline in ABILHAND Score Over 24 Weeks|"The ABILHAND Questionnaire measures a participant's perceived difficulty in performing everyday manual activities in the last 3 months. The participant completes a 56-item questionnaire by estimating their own difficulty or ease in performing each of 56 activities. Items are summed to generate a total score and transformed to a scale with a range of 0 (poor manual ability) to 100 (good manual ability); a positive change indicates an improvement in manual ability.~Data are based on an MMRM model using a common variance AR(1) variance-covariance matrix structure. Treatment, visit and treatment by visit interaction were included in the model as explanatory variables, adjusting for screening EDSS, baseline ABILHAND and prior aminopyridine as covariates. Missing data are handled using multiple imputation and baseline is defined as the Day 1 assessment."|Baseline to Week 24|Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment and available data.|||units on a scale||Standard Error|Least Squares Mean
2595627|NCT02219932|Secondary|Change From Baseline in Berg Balance Scale (BBS) Over 24 Weeks|"The BBS is a widely used assessment tool to identify balance impairment. Functional activities such as reaching, bending, transferring, and standing are evaluated on the test to evaluate balance. Participants are asked to complete 14 tasks that are rated from 0 (cannot perform) to 4 (normal performance) for a total of 56 points. BBS scores range from 0 (poor balance) to 56 (good balance); a positive change indicates improvement.~Data are based on an MMRM model using a common variance AR(1) variance-covariance matrix structure. Treatment, visit and treatment by visit interaction were included in the model as explanatory variables, adjusting for screening EDSS, baseline BBS and prior aminopyridine as covariates. Missing data are handled using multiple imputation and baseline is defined as the mean over screening and Day 1."|Baseline to Week 24|Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2595628|NCT02219932|Secondary|Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Physical Score Over 24 Weeks|"The 29-item MSIS-29 is a participant-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a participant's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 (no impact of MS) to 100 (extreme impact of MS); a negative change indicates an improvement in function.~Data are based on a mixed model for repeated measures (MMRM) model using a common variance AR(1) variance-covariance matrix structure. Treatment, visit and treatment by visit interaction were included in the model as explanatory variables, adjusting for screening EDSS, baseline MSIS-29 physical score and prior aminopyridine as covariates. Missing data are handled using multiple imputation and baseline is defined as the mean over screening and Day 1."|Baseline to Week 24|Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2595629|NCT02219932|Secondary|Proportion of Participants Achieving a Mean Improvement From Baseline of ≥ 15% in Timed Up and Go (TUG) Speed Over 24 Weeks|"TUG is a timed walking test designed to measure gait performance and balance. It measures in seconds the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm [18in], arm height 65 cm [25.6 in]), walk a distance of 3 meters (118 inches, approximately 10 feet), turn, walk back to the chair, and sit down.~A responder is defined as a participant with a mean improvement of at least 15% in TUG speed over 24 weeks compared to baseline. Baseline is defined as the mean at Screening and Day 1 visits. Estimated proportion obtained from binomial proportions. There are 2 TUG tests given, and the average across the 2 tests is used to calculate average speed. Healthy participants below the age of 79 are expected to complete this task in 7-10 seconds (American College of Rheumatology). Missing data are handled using multiple imputation and baseline is defined as the mean over Screening and Day 1."|Baseline to Week 24|Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment.|||proportion of participants|||Number
2595630|NCT02219932|Primary|Proportion of Participants Achieving a Mean Improvement of ≥ 8 Points From Baseline on the Multiple Sclerosis Walking Scale (MSWS-12) Over 24 Weeks|"MSWS-12 is a participant self-assessment of the walking limitations due to MS during the past 2 weeks. It contains 12 items that measure the impact of MS on walking. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where higher scores indicate greater impact on walking.~A responder is defined as a participant with a mean improvement of at least 8 points over 24 weeks compared to baseline. Baseline is defined as the mean at Screening and Day 1 visits. If a participant has a mean MSWS-12 score of < 0.5 over the double-blind period, and a baseline MSWS-12 score of < 8 points, the participant is counted as a responder. A participant who indicates they cannot walk at all on MSWS-12 during any double-blind visit, and who shows severe disability and an inability to walk on other efficacy assessments is counted as a non-responder. Estimated proportion obtained from binomial proportions."|Baseline to 24 weeks|Intent-to-treat population: participants who received at least 1 dose of study drug and had at least 1 postbaseline efficacy assessment.|||proportion of participants|||Number
2595631|NCT02219685|Secondary|Change From Pre-treatment Assessment in Mood Related Assessment at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Beck Hopelessness Scale (BHS)|The BHS is a 20-item scale for measuring the extent of negative attitudes about the future (pessimism) as perceived by adolescents and adults. The BHS consists of 20 true-false statements. Each of the 20 statements is scored 1 or 0. Of the 20 true-false statements, 9 are keyed FALSE, and 11 are keyed TRUE to indicate endorsement of pessimism about the future. The item scores are summed to yield a total score that can range from 0 to 20 with higher scores indicating greater hopelessness.|Baseline; Posttreatment Weeks 4 and 24|Full Analysis Set|||units on a scale||Standard Deviation|Mean
2595632|NCT02219685|Secondary|Change From Pre-treatment Assessment in Mood Related Assessment at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Beck Depression Inventory-II (BDI-II)|The BDI-II is a 21-item self-report instrument for measuring the severity of depression. Each item is rated on a 4-point scale ranging from 0 to 3. The item scores are summed to yield a derived total score that can range from 0 to 63 with lower values indicating less depression.|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2596909|NCT02203578|Primary|Incidence of aGVHD||At 28 days after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.||||||
2595633|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by WPAI: Hepatitis C - Activity Impairment|Activity impairment was measured using the WPAI: Hepatitis C questionnaire completed by participants during study visits throughout the study. This questionnaire measured the effect of hepatitis C on the ability to work and perform regular activities. Overall activity impairment is expressed as a percentage and ranges from 0% (no effect) to 100% (completely prevented from performing regular activities).|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2595634|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Work Productivity and Activity Impairment Questionnaire, Hepatitis C (WPAI: Hepatitis C) - Overall Work Impairment|Impairment in overall work productivity was measured using the WPAI: Hepatitis C questionnaire completed by participants during study visits throughout the study. This questionnaire measured the effect of hepatitis C on the ability to work and perform regular activities. Overall work impairment is expressed as a percentage and ranges from 0% (no effect) to 100% (completely prevented from working).|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2595635|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)|The FACIT-Fatigue score was measured using a 40-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale from 0 (Not at all) to 4 (Very much). The FACIT-F total score was calculated by taking the sum of all 40 individual scores and ranged from 0-160, with higher scores indicating better quality of life.|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2595636|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Chronic Liver Disease Questionnaire - HCV (CLDQ-HCV)|The CLDQ-HCV is a disease-specific questionnaire measuring health-related quality of life. CLDQ-HCV scores are calculated using participant responses to 29 questions divided into 4 domains: Activity/Energy, Emotion, Worry, and Systemic. An overall CLDQ-HCV score is calculated by taking the mean of all domain scores. Overall CLDQ-HCV scores range between 1 and 7, with higher scores representing better quality of life.|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2595637|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by SF-36 Health Survey Scale - Mental Component Score|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower score representing more disability and higher scores representing less disability.|Baseline; Posttreatment (PT) Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2595638|NCT02219685|Secondary|Change From Baseline in Health-Related Quality of Life at 4 and 24 Weeks After Discontinuation of Therapy as Assessed by Short Form 36 (SF-36) Health Survey Scale - Physical Component Score|The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. The total score is an average of the individual question scores, which are scaled 0-100 with lower scores representing more disability and higher scores representing less disability.|Baseline; Posttreatment Weeks 4 and 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2595639|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Motor|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Motor score: dominant hand fine motor speed (time) (DomHtot) and non-dominant hand fine motor speed (time) (nonDOMHtot).~For this analysis, Motor score (total) ranged from 20 to 600, with lower scores indicating better fine motor speed."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."|||units on a scale||Standard Deviation|Mean
2595640|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Executive 2 Conceptual Shift and Initiation|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 2 Conceptual Shift and Initiation score: trails B raw score (TrailBRS), age & education adjusted raw score (FASadj), color word interference score (time) (CWTrial3), and color word interference/shifting score (time) (CWTrial4).~For this analysis, Executive 2 Conceptual Shift and Initiation score (total) ranged from 1 to 570, with lower scores indicating better executive control."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."|||units on a scale||Standard Deviation|Mean
2595651|NCT02219685|Primary|Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Choline|MRS was analyzed in the LCmodel program and measured in 3 specific areas of brain (basal ganglia, frontal cortex, and dorsolateral prefrontal cortex). The cerebral metabolic signal choline was analyzed. Spectroscopy results are expressed as metabolic ratio with creatine used as the control metabolite, so there are no units of measure.|Baseline; Posttreatment Week 4|Full Analysis Set|||ratio||Standard Deviation|Mean
2595641|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Executive 1 Processing Speed|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 1 Processing Speed score: symbol search total scaled score (SSSS) and trails A total raw score (TrailARS).~For this analysis, Executive 1 Processing Speed score (total) ranged from 1 to 108, with lower scores indicating better executive control."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."|||units on a scale||Standard Deviation|Mean
2595642|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Attention Scaled Score|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Attention Scaled Score: forward digit span scaled score (FSCORESS), backward digit span scaled score (BSCORESS), and symbol span total scaled score (SYMSPSS).~For this analysis, Attention Scaled Score (total) ranged from 3 to 57, with higher scores indicating better working memory capacity and control."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."|||units on a scale||Standard Deviation|Mean
2595643|NCT02219685|Secondary|Change From Baseline in Neurocognitive Function at 24 Weeks After Discontinuation of Therapy: Memory T Score|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Memory T Score: visuospatial memory immediate total T score (BVMTTTs), visuospatial memory delayed T score (BVMTTDTS), verbal memory total T score (HVLTTTS), and verbal memory delayed T score (HVLTDTS).~For this analysis, Memory T Score (total) ranged from 80 to 320, with higher scores indicating better memory."|Baseline; Posttreatment Week 24|"Participants in the Full Analysis Set with available data were analyzed. Data for the Open-Label Phase: LDV/SOF group are not presented because this group did not have a Posttreatment Week 24 visit after receiving placebo. These participants were enrolled into the Open-Label Phase after Posttreatment Week 4."|||units on a scale||Standard Deviation|Mean
2595644|NCT02219685|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)|SVR4, SVR12, and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4, 12, and 24 weeks after stopping study treatment with LDV/SOF, respectively.|Posttreatment Weeks 4, 12, and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2595645|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Motor|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Motor score: dominant hand fine motor speed (time) (DomHtot) and non-dominant hand fine motor speed (time) (nonDOMHtot).~For this analysis, Motor score (total) ranged from 20 to 600, with lower scores indicating better fine motor speed."|Baseline; Posttreatment Week 4|Full Analysis Set|||units on a scale||Standard Deviation|Mean
2595646|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Executive 2 Conceptual Shift and Initiation|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 2 Conceptual Shift and Initiation score: trails B raw score (TrailBRS), age & education adjusted raw score (FASadj), color word interference score (time) (CWTrial3), and color word interference/shifting score (time) (CWTrial4).~For this analysis, Executive 2 Conceptual Shift and Initiation score (total) ranged from 1 to 570, with lower scores indicating better executive control."|Baseline; Posttreatment Week 4|Full Analysis Set|||units on a scale||Standard Deviation|Mean
2595647|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Executive 1 Processing Speed|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Executive 1 Processing Speed score: symbol search total scaled score (SSSS) and trails A total raw score (TrailARS).~For this analysis, Executive 1 Processing Speed score (total) ranged from 1 to 108, with lower scores indicating better executive control."|Baseline; Posttreatment Week 4|Full Analysis Set|||units on a scale||Standard Deviation|Mean
2595648|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Attention Scaled Score|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Attention Scaled Score: forward digit span scaled score (FSCORESS), backward digit span scaled score (BSCORESS), and symbol span total scaled score (SYMSPSS).~For this analysis, Attention Scaled Score (total) ranged from 3 to 57, with higher scores indicating better working memory capacity and control."|Baseline; Posttreatment Week 4|Full Analysis Set|||units on a scale||Standard Deviation|Mean
2595649|NCT02219685|Primary|Change From Baseline in Neurocognitive Function at 4 Weeks After Discontinuation of Therapy: Memory T Score|"Neurocognitive function tests were administered by a licensed clinician. The sum of following neurocognitive test scores was used to determine the Memory T Score: visuospatial memory immediate total T score (BVMTTTs), visuospatial memory delayed T score (BVMTTDTS), verbal memory total T score (HVLTTTS), and verbal memory delayed T score (HVLTDTS).~For this analysis, Memory T Score (total) ranged from 80 to 320, with higher scores indicating better memory."|Baseline; Posttreatment Week 4|Full Analysis Set|||units on a scale||Standard Deviation|Mean
2595650|NCT02219685|Primary|Change From Baseline in MRS Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: Myoinositol|MRS was analyzed in the LCmodel program and measured in 3 specific areas of brain (basal ganglia, frontal cortex, and dorsolateral prefrontal cortex). The cerebral metabolic signal myoinositol was analyzed. Spectroscopy results are expressed as metabolic ratio with creatine used as the control metabolite, so there are no units of measure.|Baseline; Posttreatment Week 4|Full Analysis Set|||ratio||Standard Deviation|Mean
2595841|NCT02217878|Secondary|Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-12h)|Exposure to ticagrelor metabolite during the first 12 hours after ticagrelor loading dose|prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h, 12h post dose||||ng*h/mL||Standard Deviation|Mean
2595652|NCT02219685|Primary|Change From Baseline in Magnetic Resonance Spectroscopy (MRS) Metabolic Ratio at 4 Weeks After Discontinuation of Therapy: NAA + NAAG|MRS was analyzed in the LCmodel program and measured in 3 specific areas of brain (basal ganglia, frontal cortex, and dorsolateral prefrontal cortex). The cerebral metabolic signal N-acetylaspartate (NAA) + N-acetylaspartylglutamate (NAAG) was analyzed. Spectroscopy results are expressed as metabolic ratio with creatine used as the control metabolite, so there are no units of measure.|Baseline; Posttreatment Week 4|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.|||ratio||Standard Deviation|Mean
2595653|NCT02219516|Primary|Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72)|CLR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose||||mL/min||95% Confidence Interval|Geometric Mean
2595654|NCT02219516|Primary|Total Body Clearance Corrected for Bioavailability (CL/F)|CL/F following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose||||L/hr||95% Confidence Interval|Geometric Mean
2595655|NCT02219516|Primary|Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72)|CLNR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose||||L/hr||95% Confidence Interval|Geometric Mean
2595656|NCT02219516|Primary|Apparent Terminal Half-life (t1/2)|t1/2 following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose||||hr||95% Confidence Interval|Geometric Mean
2595657|NCT02219516|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞)|AUC∞ following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose||||ng.hr/mL||95% Confidence Interval|Geometric Mean
2595658|NCT02219516|Primary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)|AUC last following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose||||ng.hr/mL||95% Confidence Interval|Geometric Mean
2595659|NCT02219516|Primary|Time of Occurrence of Maximum Observed Concentration (Tmax)|Tmax following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose||||hr||Full Range|Median
2595660|NCT02219516|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax following a single administration of RDEA3170 to subjects with various degrees of renal function|Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose||||ng/mL||95% Confidence Interval|Geometric Mean
2595661|NCT02219516|Secondary|Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine||Screening, Day -1 ( -24, -21, -18, -and -12 hours predose), and Day 1 (within 30 minutes prior to dosing and at 3, 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours postdose)||||Maximum Percentage (%) Change||Standard Error|Mean
2595662|NCT02219516|Secondary|Incidence of Treatment-Emergent Adverse Events||5 weeks||||Number of participants|||Number
2595663|NCT02219503|Secondary|Percentage of Participants With Post-Treatment Relapse|Post- Treatment Relapse is defined as confirmed HCV RNA >= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug [up to and including the SVR12 assessment time point] for a participant with HCV RNA < LLOQ at Final Treatment Visit who completes treatment.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants||95% Confidence Interval|Number
2595664|NCT02219503|Secondary|Percentage of Participants With On-Treatment Virologic Failure|On-Treatment Virologic Failure is defined as confirmed HCV RNA >= LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir] at any time point during treatment, or failure to suppress during treatment [all on-treatment values of HCV RNA >= LLOQ] with at least 6 weeks [defined as active study drug duration ≥ 36 days] of treatment.|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants||95% Confidence Interval|Number
2595665|NCT02219503|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|"Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.~The primary efficacy endpoints were non-inferiority and superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical threshold for sofosbuvir and peginterferon (pegIFN)/RBV for the treatment of subjects with HCV GT1b infection and cirrhosis."|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants||95% Confidence Interval|Number
2595666|NCT02219477|Secondary|Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Model for End-Stage Liver Disease (MELD) Score|MELD is a scoring system for assessing the severity of chronic liver disease. Scores range from 6 to 40, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12.|Up to post-treatment Week 12|Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12.|||percentage of participants|||Number
2595679|NCT02219308|Primary|Pain With Intrauterine Device (IUD) Placement|Distance (mm) from the left of the 100-mm visual analog scale (reflecting magnitude of pain) recorded at time of IUD Placement. Scale range is from 0mm (no pain) to 100mm (worst pain possible). A lower score (less pain) is considered a better outcome.|Moment of IUD insertion||||mm||95% Confidence Interval|Median
2595668|NCT02219477|Secondary|Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in FibroTest|The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Improvement was defined as a decrease of more than 0.2 from baseline to post-treatment Week 12.|Up to post-treatment Week 12|Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12.|||percentage of participants|||Number
2595669|NCT02219477|Secondary|Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests|"Improvement was defined as:~increase of more than 0.2 g/L from baseline to post-treatment Week 12 in albumin~decrease of more than 0.3 µmol/L from baseline to post-treatment Week 12 in bilirubin~decrease of more than 5 ng/mL from baseline to post-treatment Week 12 in alpha-fetoprotein~increase of more than 15*10^9/L from baseline to post-treatment Week 12 in platelet count~decrease of more than 0.2 from baseline to post-treatment Week 12 in international normalized ratio."|Up to post-treatment Week 12|Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12 for the respective parameter.|||percentage of participants|||Number
2595670|NCT02219477|Secondary|Percentage of Participants With SVR12 Non-Response Due to Experiencing Relapse˅12|Relapse˅12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) for a participant with HCV RNA < LLOQ at final treatment visit who completes treatment and has post-treatment HCV RNA data. Completion of treatment was defined as a study drug duration ≥ 77 days for participants assigned to 12 weeks of treatment or ≥ 154 days for participants assigned to 24 weeks of treatment. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval was calculated using the Wilson score method.|Up to 12 weeks after the last actual dose of study drug|Intent to treat population: all participants who received at least 1 dose of study drug and who had an assessment.|||percentage of participants||95% Confidence Interval|Number
2595671|NCT02219477|Secondary|Percentage of Participants With SVR12 Non-Response Due to Experiencing On-Treatment Virologic Failure|On-treatment virologic failure was defined as: confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements > 1 log˅10 IU/mL above nadir) at any time point during treatment; or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment. The 95% confidence interval was calculated using Wilson score method. SVR12 was defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window.|Up to 24 weeks during treatment|Intent to treat population: all participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2595672|NCT02219477|Secondary|Percentage of Participants With SVR12 in Group 3|SVR12, defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit, who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures.|12 weeks after the last actual dose of study drug|Intent to treat population: all participants who received at least 1 dose of study drug; participants missing data = non-responders. See imputation details in the outcome measure description.|||percentage of participants|||Number
2595673|NCT02219477|Primary|Percentages of Participants With Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2|SVR12, defined as HCV RNA < lower limit of quantification (LLOQ) in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures. The 95% confidence interval was calculated using the Wilson score method.|12 weeks after the last actual dose of study drug|Intent to treat population: all participants who received at least 1 dose of study drug; participants missing data = non-responders. See imputation details in the outcome measure description.|||percentage of participants||95% Confidence Interval|Number
2595674|NCT02219464|Secondary|Number of Participants Who Needed Airway Assistance Interventions|(jaw lift, tongue retraction, oral airway placement, mask ventilation, increase in oxygen flow rate, ect.).|During surgical procedure||||Participants|||Count of Participants
2595675|NCT02219464|Primary|Number of Participants With Oxygen Saturations Below 92%||During surgical procedure||||Participants|||Count of Participants
2595676|NCT02219321|Secondary|Withdrawal Time (Seconds)|The time to withdraw at the Cold Pressor Task immediately after 4-hours intravenous continuous lidocaine infusion|Immediately after Lidocaine Infusion||||seconds||Full Range|Mean
2595677|NCT02219321|Primary|Intensity of Pain|Visual Analog Pain Scores on a scale of 0 to 10 (0=no pain and 10=worst pain)|Immediately after continuous 4-hours Intravenous lidocaine infusion|Chronic pain patients with opioid precription|||units on a scale 0 to 10||Full Range|Median
2595678|NCT02219308|Secondary|Median Pain Scores for All Time Points|Distance (mm) from the left of the 100-mm visual analog scale of pain at various time points. Scale range is 0mm (no pain) to 100mm (worst pain possible). Lower scores are considered better outcomes.|Anticipation of procedure through 5 minutes after IUD placement||||mm||95% Confidence Interval|Median
2595680|NCT02219282|Secondary|Insertion Time of Laryngeal Mask|Duration of insertion (second) Laryngeal Mask;second|During placement of Laryngeal Mask||||seconds||Standard Deviation|Mean
2595684|NCT02219282|Primary|Number of Participants With Successful Laryngeal Mask Placement|The aim of this study is primarily to measure the success of placement on first try in dentulous and edentulous elderly patients for success of placement on first try.|Baseline|For one patient in each group, dentulous and edentulous, insertion of the LMU was unsuccessful on the third attempt, and these patients were intubated; therefore, these two patients were excluded from the study and were not included in the statistical analysis|||Participants|||Count of Participants
2595685|NCT02219256|Primary|Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose||First dose up to Day 78|The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits.|||participants|||Number
2595686|NCT02219256|Primary|Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose||First dose up to Day 78|The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits.|||participants|||Number
2595687|NCT02219256|Secondary|Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab)|Results for ADA analysis were reported.|Baseline up to Day 78|The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits. Due to change in planned analysis testing of NAb activity of ADA positive samples was not analysed.|||percentage of participants|||Number
2595688|NCT02219256|Secondary|AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-079||Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose|The PK analysis set included all participants who received study drug and had at least 1 measurable serum concentration of TAK-079. PK analysis was performed for TAK-079 0.6 mg/kg SC dose groups only, since serum concentrations of TAK-079 were below the LLOQ at all PK sampling time-points for remaining arms.|||ng*day/mL||Standard Deviation|Mean
2595689|NCT02219256|Secondary|AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079||Day 1 pre-dose and at multiple time points (up to Day 78) post-dose|The PK analysis set:all participants who received study drug and had at least 1 measurable serum concentration of TAK-079.A valid AUClast was derived for TAK-079 0.6 mg/kgSC dose group only, since serum concentrations of TAK-079 were either below the LLOQ at all PK sampling time-points or too limited to estimate AUClast reliably for remaining arms.|||nanogram*day per milliliter (ng*day/mL)||Standard Deviation|Mean
2595690|NCT02219256|Secondary|Cmax: Maximum Observed Serum Concentration for TAK-079||Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose|The pharmacokinetic(PK) analysis set included all participants who received study drug and had at least 1 measurable serum concentration of TAK-079. PK analysis was performed for TAK-079 0.03, 0.06 mg/kg IV and 0.6 SC mg/kg dose groups only, since serum concentrations of TAK-079 were below the LLOQ at all PK sampling time-points for remaining arms.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2595691|NCT02219256|Primary|Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose||First dose up to Day 78|The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits.|||participants|||Number
2595692|NCT02219256|Primary|Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE was assessed according to severity; mild (transient and easily tolerated by the participant), moderate (causes the participant discomfort and interrupts the participant's usual activities) and severe (causes considerable interference with the participant's usual activities).|First dose up to Day 94|The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits.|||participants|||Number
2595693|NCT02219087|Secondary|Hospital Readmission Not Including Admissions Planned Procedures||Participants will be followed for 30 days after leaving the hospital.||||participants|||Number
2595694|NCT02219087|Secondary|Total Cost of Care (Dollars)||Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.||||Dollars||Full Range|Median
2595695|NCT02219087|Secondary|Number of Participants With Opioid-related Adverse Events (ORAEs) During Hospital Stay|"Nausea~Vomiting~Constipation~Ileus~Pruritus~Respiratory depression~Over-sedation"|Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.||||participants|||Number
2595696|NCT02219087|Secondary|Opioid Consumption in Oral Morphine Equivalents (OMEs, in Milligrams)||Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.||||Milligrams||Standard Deviation|Mean
2595697|NCT02219087|Secondary|Length of Stay (LOS, in Days)||Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.||||Days||Standard Deviation|Mean
2595698|NCT02219087|Secondary|Mean Visual Analog Scale (VAS) Pain Scores During Hospital Stay|VAS was measured using a scale that ranged from 0 to 10. Higher scores indicate more pain, or a worse outcome. Patients had pain measured a variable number of times following surgery before discharge. Mean VAS score during the hospital stay for each patient was calculated|Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.||||Units on a scale||Standard Deviation|Mean
2595699|NCT02219087|Primary|Number Physical Therapy Sessions Necessary for Discharge|Number of physical therapy (PT) sessions necessary for discharge. A significant decrease in the number of sessions will be defined as ≥ 2. Typically, there are 2 sessions per day, with each patient completing an average of 4-5 sessions during their admission.|Participants will be followed for the duration of their hospital stay, an expected average of 2.5 days.||||Physical Therapy Sessions||Standard Deviation|Mean
2595700|NCT02219048|Secondary|Number of Daily Puffs of Rescue Medication|The use of rescue bronchodilators (albuterol or levalbuterol) for symptomatic relief of asthma in a 24-hour period was recorded by the participant.|Baseline, Week 1, Week 2, Week 3, and Week 4|The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.|||puffs per day||Standard Deviation|Mean
2595701|NCT02219048|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ)-5 Score at Week 1, Week 2, Week 3, and Week 4|The 5-question version of the Juniper ACQ is a validated questionnaire to evaluate asthma control. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score was the mean of the responses. Mean scores of <= 0.75 indicate well-controlled asthma, scores between 0.76 and less than (<) 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline, Week 1, Week 2, Week 3, and Week 4|The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.|||units on a scale||Standard Deviation|Mean
2595702|NCT02219048|Secondary|Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF)|The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. The changes from baseline (CFB) at each week and over 4 weeks were analyzed.|Baseline, Week 1, Week 2, Week 3, and Week 4|The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.|||liters per minute||Standard Deviation|Mean
2595703|NCT02219048|Secondary|Number of Night Time Awakenings Per Week|The number of nocturnal awakenings due to asthma symptoms was recorded by the participant.|Baseline, Week 1, Week 2, Week 3, and Week 4|The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.|||night awakenings per week||Standard Deviation|Mean
2595704|NCT02219048|Secondary|Change From Baseline in Asthma Symptom Scores|Participants used a daily diary assessment to record overall asthma symptom scores twice a day (morning and evening). Questions included extent of albuterol use, symptoms of wheezing, breathlessness, chest tightness, and cough. The visit dependent asthma symptom scores were calculated based on the item in the daily diary assessment. A participant summarized her/his daily frequency of asthma symptoms during the last 24 hours by the assignment of an integer score (0,1,2,3 or 4). The score=0 value denoted the day without symptoms and the score=4 value denoted the day where symptoms occurred all of the time. The asthma symptom scores were calculated by averaging the values of the daily scores within visit-dependent time window. Higher score indicates asthma worsening|Baseline, Week 1, Week 2, Week 3, and Week 4|The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.|||units on a scale||Standard Deviation|Mean
2595705|NCT02219048|Secondary|Change From Baseline in Forced Expiratory Volume in 6 Seconds (FEV6)|FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration.|Baseline, Week 1, Week 2, Week 3, and Week 4|The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.|||liters||Standard Deviation|Mean
2595706|NCT02219048|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Week 1, Week 2, Week 3, and Week 4|The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.|||liters||Standard Deviation|Mean
2595707|NCT02219048|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Baseline was defined as the latest measurement before first dosing.|Baseline, Week 1, Week 2, Week 3, and Week 4|The mITT analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo; n=number of participants analyzed in respective arms for category.|||liters||Standard Deviation|Mean
2595708|NCT02219048|Secondary|Time to Asthma Worsening Event|The time post randomization that the first asthma worsening event occurred (defined above).|Baseline up to follow-up period (Week 16)|The modified intent-to-treat (mITT) analysis set initially included all randomized participants who received at least 1 dose of PF-03715455 or placebo. Only 7 participants (4 in PF-03715455 and 3 in placebo) were included in the presented descriptive analysis, since other observations were censored by study termination.|||days||Full Range|Median
2595709|NCT02219048|Primary|Percentage of Participants With Asthma Worsening Events|Asthma worsening was defined as one of the following events: greater than or equal to (>=) 30% reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days; >=6 additional rescue puffs of albuterol or levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; deterioration of asthma (as determined by the Investigator) requiring systemic steroid treatment, an increase in inhaled corticosteroids >=4 times the last dose received prior to discontinuation from the study, or hospitalization due to asthma.|Baseline up to follow-up period (Week 16)|The modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of PF-03715455 or placebo.|||percentage of participants|||Number
2595710|NCT02219009|Secondary|Proportion of Time During the Study Period When Participants Wear Their Patches|Proportion of time during the study period when participants wear their patches; the time duration of patch wearing will be calculated based on digital health data. Percentage of participants' patch wearing time was calculated as (total duration a patch was worn / trial duration) x 100.|Baseline to Week 8|ITT population - all participants who entered the trial and used the MIND1 system.|||% of time participants wore patch||Standard Deviation|Mean
2595745|NCT02218424|Primary|Postoperative Pain|"Postoperative pain will be measured at 15 minute time intervals in the post-anesthesia care unit (PACU). Pain scores will be evaluated using a standardized validated scale (the Faces Pain Scale Revised (FPS-R)). The Faces Pain Scale is a validated, patient reported, 0 (no pain) to 10 (worst pain imaginable) numeric rating scale. Pain scores will be multiplied by the time spent at each pain score for a calculated Area Under the Curve value, ranging from 0 to 900, with lower values indicating more favorable and lower pain scores."|90 minutes||||scores on a scale*minutes||Inter-Quartile Range|Median
2595711|NCT02219009|Secondary|Proportion of Participants Able to Pair & Apply a Patch Successfully, Independently, or With Minimum Assistance, by the End of the Week 8 Study Visit, as Defined by a SAUSS-HCP Score of 71 to 100.|Proportion of participants who are able to pair and apply a patch successfully, independently, or with minimum assistance, by the end of the Week 8 study visit (or early termination, if applicable), as defined by a Participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP) score of 71 to 100. Participants were considered to have paired and applied a patch independently or with minimal assistance if their SAUSS-HCP score was at least 71 for at least one postbaseline score.|Baseline to Week 8|ITT population - all participants who entered the trial and used the MIND1 system.|||percentage of participants||95% Confidence Interval|Number
2595712|NCT02219009|Primary|Proportion of Participants Who Are Able to Pair & Apply a Patch Independently & Successfully by the End of the Week 8 Study Visit as Defined by a Score of 91 to 100 on the Subject Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP)|Proportion of participants who are able to pair and apply a patch independently and successfully by the end of the Week 8 study visit (or early termination, if applicable), as defined as a score of 91 to 100 on the participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP). A participant was considered to have successfully and independently applied a patch if the SAUSS-HCP was at least 91 for at least one postbaseline score.|Baseline to Week 8|The intent-to-treat (ITT) population - all participants who entered the trial and used the MIND1 system|||percentage of participants||95% Confidence Interval|Number
2595713|NCT02218736|Secondary|Change in Behavioral Measure of Anhedonia Using the Probabilistic Reward Task|To evaluate the impact of CERC-501 relative to placebo on a behavioral measure of anhedonia using the Probabilistic Reward Task (PRT). The PRT will be carried out at baseline and after 8 weeks of double-blind treatment to assess the effects on a behavioral outcome measure that assessed reward-related function (level of reward learning). The score obtained is a ratio of the number of times participants correctly choose the high reward stimuli versus the low rewarding stimuli|baseline, Week 8|The primary and secondary endpoints are analyzed for patients who meet the definition of completers for week 8 of the study.|||Ratio (Response Bias Score)||95% Confidence Interval|Mean
2595714|NCT02218736|Secondary|Clinical Anhedonia Measured by the Snaith-Hamilton Pleasure Scale (SHAPS; Total Score)|"To determine if CERC-501 is superior to placebo in improving a clinical self-report measure of anhedonia using the Snaith Hamilton Pleasure Scale (SHAPS). A single value was calculated for the average over 8 weeks. The SHAPS is a well-validated 14-item questionnaire used to assess anhedonia. It asks participants to agree or disagree with statements of hedonic response in pleasurable situations. Four responses are possible: Strongly disagree, Disagree, Agree, or Strongly agree. Each item is worded so that higher scores indicate greater pleasure capacity. A total score is derived by summing the responses to each item. Items answered strongly agree are coded as 1, while strongly disagree are coded a score of 4. Therefore, scores on the SHAPS can range from 14 to 56, with higher scores corresponding to higher levels of anhedonia."|8 weeks|The primary and secondary endpoints are analyzed for patients who meet the definition of completers for week 8 of the study.|||score on a scale||95% Confidence Interval|Mean
2595715|NCT02218736|Primary|Change in Ventral Striatal Activation Occurring in Anticipation of Reward During the Monetary Incentive Delay Task Measured by fMRI|Establish POC (Proof of Concept) for KOR (Kappa Opioid Receptor) antagonism by evaluating the impact of CERC-501 relative to Placebo on reward-related neural circuitry in terms of ventral striatal activation during anticipation of reward during the Monetary Incentive Delay Task. Evaluation by fMRI (Functional magnetic resonance imaging). The BOLD (Blood Oxygen Level-Dependent) score on the Z-scale represents how far the actual measured intensity is from the expected in the template. A score of 0 would correspond to the mean/median, a score of 1.65 would represent the 90-percentile, -1.65 the 10-percentile, and so on, according to a standard normal distribution.|baseline, Week 8|The primary and secondary endpoints are analyzed for patients who meet the definition of completers for week 8 of the study.|||Z score||95% Confidence Interval|Mean
2595716|NCT02218697|Secondary|Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects.|"Fold antibody concentration increases post-vaccination/pre-vaccination ≥ 2 and ≥ 4.~The anti-pneumococcal serotypes assessed were 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F."|At 28 days post-vaccination with Pneumovax™ 23|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Subjects|||Number
2595717|NCT02218697|Secondary|Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F)|"Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) PRE = Pre -vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group.~POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group."|At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2595718|NCT02218697|Secondary|Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F|"The pneumococcal antigen testing was performed, as determined by ELISA cut-offs of ≥0.05 µg/mL and a seroprotection cut-off of ≥ 0.2 µg/ml.~PRE = Pre-vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group.~POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group."|At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Subjects|||Number
2595816|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|1 hour post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||P2Y12 Reaction Units||Inter-Quartile Range|Median
2595719|NCT02218697|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains.|MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).|At Day 28|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2595720|NCT02218697|Secondary|Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).|At Day 28|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Subjects|||Number
2595721|NCT02218697|Secondary|Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 0 and Day 28|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Subjects|||Number
2595722|NCT02218697|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).|At Day 0 and Day 28|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2595723|NCT02218697|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|Throughout the study period (Days 0-180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Subjects|||Number
2595724|NCT02218697|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|Within the 28-day (Days 0-27) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Subjects|||Number
2595725|NCT02218697|Secondary|Number of Subjects Reporting the Occurrence of Potential Immune Mediated Diseases (pIMDs)|"Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.~Any was defined as any occurrence of pIMD(s) regardless of intensity grade or relationship to vaccination. Related was defined as pIMD assessed by the investigator to be causally related to the study vaccination."|During the entire study period (Days 0-180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Subjects|||Number
2595726|NCT02218697|Secondary|Number of Subjects Reporting the Occurrence of Medically Attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s) regardless of intensity grade or relationship to vaccination. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination.|Throughout the study period (Days 0-180)|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Subjects|||Number
2595727|NCT02218697|Secondary|Duration of Solicited General AEs.|Duration was defined as number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Days||Full Range|Median
2595728|NCT02218697|Secondary|Duration of Local Adverse Events|Duration was defined as number of days with any grade of local symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Days||Full Range|Median
2606281|NCT02101515|Other Pre-specified|Neonatal Seizures (Neonate)|Diagnosed by neonatology, one neonate was analyzed per mother|until discharge, usually < 5 days||||Participants|||Count of Participants
2595729|NCT02218697|Secondary|Number of Subjects Reporting Solicited General Adverse Events (AEs)|"Solicited general symptoms assessed were fatigue, gastrointestinal symptoms*, headache, joint pain, muscle aches, shivering, sweating and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal everyday activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as temperature greater than (>)39.0°C.~*Gastrointestinal (GI) symptoms included nausea, vomiting, diarrhoea and/or abdominal pain"|Within 7 days (Days 0 - 6) after each dose and across doses.|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Subjects|||Number
2595730|NCT02218697|Secondary|Number of Subjects Reporting Solicited Local Adverse Events (AEs)|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. > 100mm.|Within 7 days (Days 0 - 6) after each dose and across doses.|The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.|||Subjects|||Number
2595731|NCT02218697|Primary|Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A).|Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) and adjusted GMC ratio (Control Group/Co-Ad Group).|At 28 days after Pneumovax™ 23 vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||ug per ml||95% Confidence Interval|Geometric Mean
2595732|NCT02218697|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains.|HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios (Control Group/Co-Ad Group). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 28 post Influsplit™ Tetra vaccination|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2595733|NCT02218541|Secondary|Number of Participants With Provisional Crown Fit at Delivery|To assess if the Provisional Crown was able to be cemented at time of abutment connection was reported as 'Yes' or 'No.'|8 weeks post surgery||||Participants|||Count of Participants
2595734|NCT02218541|Secondary|Number of Participants With a Soft Tissue Response of Bleeding|To assess the condition of the peri-implant mucosa, those with a soft tissue response of bleeding upon probing were counted. Fisher's exact test will be used after the site has been evaluated for presence of bleeding or not.|6 months post surgery||||Participants|||Count of Participants
2595735|NCT02218541|Primary|Number of Participants With Abutment Margin Exposure > 0|Margin exposure of the abutment between groups at 6 months post surgery.|up to 6 months post surgery||||Participants|||Count of Participants
2595736|NCT02218463|Secondary|Composite Severity Scale of Labial Adhesion Over Time|Response to treatment of labial adhesion is dependent not only upon the size of the adhesion but also the thickness. A more accurate measurement of response to treatment would, therefore, incorporate both measurements. For this study, the percentage of closure of the introitus at presentation was assigned an ordinal value as follows: 1=25%, 2=50%, 3=75%, and 4=100%. The degree of thickness of the labial adhesion was also measured in a similar fashion: 1=thin, 2=intermediate and 3= thick. Those that were resolved received a rating of 0 on both scales. A composite severity scale was created by multiplying the value assigned to the percentage of introital closure by that assigned to the thickness of the adhesion for each of the 3 study visits. The composite severity scale ranged from 0 to 12. This allowed a comparison of treatment effect between each group over time wherein a lower composite severity score corresponded to a less severe labial adhesion.|3 weeks and 6 weeks||||units on a scale||Standard Deviation|Mean
2595737|NCT02218463|Primary|Complete Resolution of Labial Adhesion.|The first assessment will be 3 weeks after initiation of treatment. The final assessment will be 6 weeks after initiation of treatment.|3 weeks and 6 weeks||||Participants|||Count of Participants
2595738|NCT02218424|Secondary|Parent Satisfaction|Parent satisfaction will be assessed on postoperative days 1, 3, and 7. This will be determined by asking the parents one question about their satisfaction with the overal anesthetic care on a numeric rating scale of 1 to 10, with higher scores indicating greater satisfaction and better outcome.|7 days||||Units on a Numeric Rating Scale||Inter-Quartile Range|Median
2595739|NCT02218424|Secondary|Time to PACU Discharge|The time to fulfilling discharge criteria, in minutes, from the PACU will be recorded|Approximately 90 minutes||||Minutes||Standard Deviation|Mean
2595740|NCT02218424|Secondary|Respiratory Depression|The incidence of the presence of respiratory depression will be measured while the patient is in the recovery room.|90 minutes||||Participants|||Count of Participants
2595741|NCT02218424|Secondary|Number of Patients With Postoperative Vomiting|The incidence of postoperative vomiting will be measured while in the recovery room.|90 minutes||||participants|||Number
2595742|NCT02218424|Secondary|Emergence Delirium|The incidence of emergence delirium determined using the pediatric anesthesia emergence delirium (PAED) scale while the patient is in the PACU. The PAED scale ranges from scores of 0 to 20, with lower scores indicating less agitation, more awareness, less aggressiveness, and a more favorable outcome in the post-anesthesia recovery period.|5 minutes after awakening in the recovery room||||Units on a scale, PAED||Inter-Quartile Range|Median
2595743|NCT02218424|Secondary|Postoperative Pain at Home|Postoperative pain at home will be measured using the Parent's Post-Operative Pain Measure (PPPM) questionnaire on postoperative days 1, 3, and 7. The PPPM gives a score to child behavior which suggests they are in pain after surgery with scores ranging from 0 to 15 with lower values suggesting better pain outcome.|7 days||||PPPM Scale Score (Range: 0-15)||Inter-Quartile Range|Median
2606282|NCT02101515|Other Pre-specified|Birth Weight (Neonate)|One neonate was analyzed per mother|at time of delivery||||grams||Standard Deviation|Mean
2595746|NCT02218372|Secondary|Acceptance of Formulation (Palatability Assessment) in All Participants at First Administration of Study Drug and at Day 7|Acceptance of formulation was evaluated in all participants who received fidaxomicin oral suspension and vancomycin oral liquid (i.e., participants from birth to =< 6 years and participants > 6 years unable to swallow tablets) by means of a five-point rating scale (awful, poor, fair, good, excellent) by unblinded staff if hospitalized, and by the participant/parents/legal guardian when at home.|Days 1 and 7|The analysis population consisted of the FAS.|||Participants|||Count of Participants
2595747|NCT02218372|Secondary|MPRconc Within 24 Hours of a Dose|Drug concentration was derived from the stool samples collected.|Within 24 hours of a dose taken between day 5 and day 10|The analysis population consisted of the PKAS.|||ratio||Standard Deviation|Mean
2595748|NCT02218372|Secondary|Fecal Concentrations of Metabolite OP-1118|Drug concentration was derived from the stool samples collected.|Within 24 hours of a dose taken between day 5 and day 10|The analysis population consisted of the PKAS.|||μg/g||Standard Deviation|Mean
2595749|NCT02218372|Secondary|Fecal Concentrations of Fidaxomicin|Drug concentration was derived from the stool samples collected.|Within 24 hours of a dose taken between day 5 and day 10|The analysis population consisted of the PKAS.|||μg/g||Standard Deviation|Mean
2595750|NCT02218372|Secondary|Metabolite-to-Parent Ratio (MPRconc)|Drug concentration was derived from the blood samples collected.|Within 30 minutes predose and 1 to 5 hours postdose taken between day 5 and day 10|The analysis population consisted of the PKAS.|||ratio||Standard Deviation|Mean
2595751|NCT02218372|Secondary|Plasma Concentrations of Metabolite OP-1118|Drug concentration was derived from the blood samples collected.|Within 30 minutes predose and 1 to 5 hours postdose taken between day 5 and day 10|The analysis population consisted of the PKAS.|||ng/mL||Standard Deviation|Mean
2595752|NCT02218372|Secondary|Plasma Concentrations of Fidaxomicin|Drug concentration was derived from the blood samples collected.|Within 30 minutes predose and 1 to 5 hours postdose taken between day 5 and day 10|The analysis population consisted of the pharmacokinetics analysis set (PKAS). The PKAS consisted of all participants randomized to fidaxomicin, having received at least 1 dose of fidaxomicin and having at least 1 valid measurement of plasma concentration or fecal concentration of fidaxomicin or its main metabolite OP-1118.|||ng/mL||Standard Deviation|Mean
2595753|NCT02218372|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures which did not necessarily have a causal relationship with this treatment. This included abnormal laboratory tests, vital signs, electrocardiogram data or physical examinations that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The following standard with 3 grades was used to measure the severity of AEs, including abnormal clinical laboratory values: ● Mild: No disruption of normal daily activities ● Moderate: Affected normal daily activities ● Severe: Inability to perform daily activities. A treatment-emergent adverse event (TEAE) was defined as an AE observed after starting administration of the test drug/comparative drug.|From the first dose of study drug administration up to 30 days after EOT (up to day 40)|The analysis population consisted of the safety analysis set (SAF), which consisted of all randomized participants who received at least 1 study drug dose. In the SAF, participants were allocated to the treatment arm corresponding to study drug first administered (fidaxomicin or vancomycin), even if it differed from the treatment randomized to.|||Participants|||Count of Participants
2595754|NCT02218372|Secondary|Time to Recurrence of CDAD for Participants With CCR at EOT +2 Days|Time to recurrence was defined as the time (days) from CCR until the onset of recurrence. Time to recurrence of CDAD by Kaplan-Meier Method. Data for median was estimated and the 95% CI could not be estimated due to low event rate. Data not estimable denoted as NA. Participants with CCR at EOT+2 days, who completed the follow-up period but did not experience a recurrence of CDAD were censored at EOT+30 days and those who did not complete the follow-up period and discontinued during this period and did not experience a recurrence of CDAD were censored at day of discontinuation.|Up to day 40|The analysis population consisted of the FAS (participants with CCR at EOT +2 days).|||days||95% Confidence Interval|Median
2595755|NCT02218372|Secondary|Time to Resolution of Diarrhea (TTROD)|TTROD for ages from birth < 2 years was defined as time elapsing (hours rounded up from minutes > 30) from treatment start (time of first study drug dose) to diarrhea resolution (time of last episode of watery diarrhea the day prior to the first of 2 consecutive days without watery diarrhea sustained through EOT). TTROD for ages ≥ 2 years to < 18 years was defined as time elapsing (hours rounded up from minutes > 30) from treatment start (time of first dose) to diarrhea resolution (time of the last UBM the day prior to the first of 2 consecutive days of < 3 UBMs sustained through EOT). TTROD by Kaplan-Meier Method. Those who completed treatment but did not show diarrhea resolution until EOT were censored at Day 10/240 hours. Those who did not complete treatment, discontinued earlier but did not show diarrhea resolution until disc. day were censored at disc. (days converted to hours). Those whose diarrhea did not continue after first dose were included with a TTROD of 1 hour.|Up to day 10|The analysis population consisted of the FAS.|||hours||95% Confidence Interval|Median
2595756|NCT02218372|Secondary|Percentage of Participants With Recurrence of CDAD at EOS (EOT +30 Days)|Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.|Up to day 40|The analysis population consisted of the FAS (participants with CCR at EOT +2 days).|||percentage of participants||95% Confidence Interval|Number
2595817|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|30 minutes post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||P2Y12 Reaction Units||Inter-Quartile Range|Median
2595757|NCT02218372|Secondary|Percentage of Participants With GC at EOS (EOT +30 Days)|GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. Global Cure at EOT +30 days was derived using MI in case ICR/CCR=Missing (SCR not assessed) following Rubin's multiple imputation method.|Up to day 40|The analysis population consisted of the FAS.|||percentage of participants||95% Confidence Interval|Number
2595758|NCT02218372|Secondary|Percentage of Participants With SCR at End of Study (EOS) (EOT +30 Days)|SCR at EOS was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOS (EOT + 30 days) during the follow-up period. Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.|Up to day 40|The analysis population consisted of the FAS (participants with CCR at EOT +2 days).|||percentage of participants||95% Confidence Interval|Number
2595759|NCT02218372|Secondary|Percentage of Participants With Recurrence of CDAD at EOT +23 Days|Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.|Up to day 33|The analysis population consisted of the FAS (participants with CCR at EOT +2 days).|||percentage of participants||95% Confidence Interval|Number
2595760|NCT02218372|Secondary|Percentage of Participants With GC at EOT +23 Days|GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. No multiple imputation method (MI) was used for global cure at EOT + 23 days.|Up to day 33|The analysis population consisted of the FAS.|||percentage of participants||95% Confidence Interval|Number
2595761|NCT02218372|Secondary|Percentage of Participants With SCR at EOT +23 Days|SCR at EOT + 23 days was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOT + 16 days during the follow-up period. Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.|Up to day 33|The analysis population consisted of the FAS (participants with CCR at EOT +2 days).|||percentage of participants||95% Confidence Interval|Number
2595762|NCT02218372|Secondary|Percentage of Participants With Recurrence of CDAD at EOT +16 Days|Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.|Up to day 26|The analysis population consisted of the FAS (participants with CCR at EOT +2 days).|||percentage of participants||95% Confidence Interval|Median
2595763|NCT02218372|Secondary|Percentage of Participants With GC at EOT +16 Days|GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. No multiple imputation method (MI) was used for global cure at EOT + 16 days.|Up to day 26|The analysis population consisted of the FAS.|||percentage of participants||95% Confidence Interval|Number
2595764|NCT02218372|Secondary|Percentage of Participants With SCR at EOT +16 Days|SCR at EOT + 16 days was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOT + 16 days during the follow-up period. Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.|Up to day 26|The analysis population consisted of the FAS (participants with CCR at EOT +2 days).|||percentage of participants||95% Confidence Interval|Number
2595765|NCT02218372|Secondary|Percentage of Participants With Recurrence of CDAD at EOT +9 Days|Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.|Up to day 19|The analysis population consisted of the FAS (participants with CCR at EOT +2 days).|||percentage of participants||95% Confidence Interval|Number
2595766|NCT02218372|Secondary|Percentage of Participants With Global Cure (GC) at EOT +9 Days|GC was reported as a positive (Yes) or negative (No) outcome and was calculated using SCR and ICR/CCR values according to the following conditions: ● if ICR/CCR=Yes and SCR=Yes, then Global Cure was Yes. ● if ICR/CCR=Yes and SCR =No, then Global Cure was No. ● if ICR/CCR=No (SCR not assessed), then Global Cure was No. ● if ICR/CCR=Missing (SCR not assessed), then Global Cure was set to No. No multiple imputation method (MI) was used for global cure at EOT + 9 days.|Up to day 19|The analysis population consisted of the FAS.|||percentage of participants||95% Confidence Interval|Number
2595767|NCT02218372|Secondary|Percentage of Participants With Sustained Clinical Response (SCR) at EOT +9 Days|SCR at EOT + 9 days was defined as CCR (EOT + 2 days) without CDAD recurrence until assessment at EOT +9 days during the follow-up period. Recurrence for ages from birth to < 2 years was defined as re-establishment of watery diarrhea after CCR to an extent that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic Clostridium difficile (C. difficile) in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy. Recurrence for ages ≥ 2 years < 18 years was defined as re-establishment of diarrhea after CCR to an extent (as measured by the frequency of UBMs) that was greater than that noted on the last day of study drug with positive direct or indirect testing for the presence of toxigenic C. difficile in stool and that, in the investigator's opinion, required retreatment with CDAD anti-infective therapy.|Up to day 19|The analysis population consisted of the FAS (participants with CCR at EOT +2 days).|||percentage of participants||95% Confidence Interval|Number
2595768|NCT02218372|Primary|Percentage of Participants With Confirmed Clinical Response (CCR) at End of Treatment (EOT) +2 Days|Initial clinical response (ICR) for ages from birth to < 2 years was defined as absence of watery diarrhea for 2 consecutive treatment days, remaining well until study drug discontinuation. ICR for ages ≥ 2 years to < 18 years was defined as improvement in number and character of bowel movements as determined by < 3 unformed bowel movements (UBMs) per day for 2 consecutive treatment days, remaining well until study drug discontinuation. CCR was defined for both age groups as not requiring further CDAD therapy within 2 days after study drug completion, and was reported with a positive (Yes) or negative (No) outcome. Resolution of diarrhea was assessed during interviews of participant/parent/legal guardian, supplemented by review of personal records (if hospitalized) and checked for presence of watery diarrhea (ages from birth to < 2 years) or number of UBMs (for ages ≥ 2 years to < 18 years).|Up to day 12|The analysis population consisted of the full analysis set (FAS) which consisted of all randomized participants who received at least 1 dose of study drug. In the FAS, participants were allocated to the treatment arm corresponding to the study medication that the participant was randomized to (treatment allocation as randomized).|||percentage of participants||95% Confidence Interval|Number
2595769|NCT02218320|Primary|Percentage of Total CD8+ T-cells With CCR5 Expression|Local immunologic markers in gastrointestinal tract tissues|2 to 6 hours post dose||||percentage of total cells||Full Range|Median
2595770|NCT02218320|Primary|RNA Concentrations From Gastrointestinal Tissues|We measured RNA concentrations in copies/1000cells for both drug groups|2 to 6 hours post dose||||copies/1000cells||Full Range|Median
2595771|NCT02218320|Primary|Rectal Tissue Concentrations of Ralegravir and Dolutegravir||2 to 6 hours post dose||||ng/g||Full Range|Median
2595772|NCT02218307|Secondary|Quality of Life in Chronic Rhinosinusitis Patients|Measuring the quality of life in chronic rhinosinusitis through completion of a questionnaire named Visual Analog Scale for Nasal Obstruction/Congestion. VAS for nasal obstruction is scale from 0 to 100 where 100 mean worse.|3 months||||Units on a scale||Standard Deviation|Mean
2595773|NCT02218307|Primary|Quality of Life in Chronic Rhinosinusitis Patients|"Measuring the quality of life in chronic rhinosinusitis through completion of a questionnaire named SNOT 20 ( 20 questions for Sino-Nasal Outcome Test)~Snot20:~Scale 1 to 5 for 20 symptoms numbered below where 5 is the worst symptom. Total SNOT is scale from 0-100 where 100 is the worst.~The following are the elements:~1. need to blow 2. sneezing 3. runny nose 4. cough 5. postnasal drip 6. Thick nasal discharge 7. Ear fullness 8. Dizziness 9. Ear pain 10. facial pain/pressure 11. difficulty falling asleep 12. wake up at night 13. lack of a good night's sleep 14. wake up tired 15. Fatigue 16. Reduced productivity 17. Reduced concentration 18. frustrated/ restless/irritable 19. sad 20. Embarrassed"|3 months||||Units on a scale||Standard Deviation|Mean
2595774|NCT02218268|Primary|Determine the Difference Between Acute Effect of a Mixed Meal on Radial Artery Stiffness in Subjects With Type I Diabetes Mellitus Who do and Who do Not Take an Additional Bolus of Insulin.|Determine the difference between acute effect of a mixed meal on radial artery stiffness in subjects with type I diabetes mellitus who do and who do not take an additional bolus of insulin. Radial tonometry is used to calculate the augmentation index (AI). AI is expressed as a percentage of the pulse pressure and represents the difference between the first and second peaks of the central arterial waveform. The stiffer the artery the more positive elevation of the AI and the machine will indicate stiffness using a color indicator (green less stiff and red being stiff). AI is measured using the SphygmoCor VX version 7.01 (AtCor Medical, Syndey, Australia). AI will be corrected to a heart rate of 75 to eliminate differences related to heart rate variation.|From baseline to one hour then 2 hours||||Percent of Pulse Pressure||95% Confidence Interval|Mean
2595818|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|prior to the initial ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||P2Y12 Reaction Units||Inter-Quartile Range|Median
2595775|NCT02218242|Primary|Detection of Occult Pathologic N2 Lymph Nodes|Participants undergoing resection of lung tumors will have laparoscopic thoracic wall ultrasound in an attempt to identify pathologic N2 lymph nodes. Data will be presented as the ratio of lymph nodes identified as cancerous to the total number of lymph nodes investigated with the ultrasound technique.|At time of surgery|An insufficient number of participants were consented to generate meaningful data for this study. We reached an enrollment of less than 10% of what our power calculations suggested we needed. No pathologic lymph nodes were identified, thus the percent of pathologic lymph nodes is in fact zero|||percentage of pathologic lymph nodes|lymph nodes||Number
2595776|NCT02218216|Primary|mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software|To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including Volumetry, Kurtosis, Resting State [RS], functional magnetic resonance imaging [fMRI], and additional post-processing modules may be provided|Baseline to 3 months|Study was terminated and no subject outcome data were collected||||||
2595777|NCT02218203|Primary|Percent Change in Peak Pain Intensity|Primary outcome was percent change from baseline in mean pain intensity at Cmax (transformed Gracely Scale; 0-35). Higher values on the Gracely scale represent greater pain intensity; the greater the percent change from baseline in mean pain intensity, the bigger the reduction in pain intensity.|30 minutes post-infusion (Cmax)|Central neuropathic pain following SCI; we present the primary efficacy endpoint (percent change in peak pain intensity) of this nested IV lidocaine dose-response clinical trial independent of the dextromethorphan doses, because the distribution of the dextromethorphan doses is balanced across the lidocaine treatment arms.|||percentage change from baseline||Standard Error|Mean
2595778|NCT02218190|Secondary|Complications and Adverse Event|Number of patients with complication/adverse event.|14 days or until hospital discharge, which ever occurs first||||Participants|||Count of Participants
2595779|NCT02218190|Primary|Length of Hospital Stay|To determine the effect of alvimopan on overall length of hospital stay in patients undergoing PSF.|14 days or until hospital discharge whichever occurs first||||Hours||Standard Deviation|Mean
2595780|NCT02218190|Primary|Recovery of Bowel Function|To determine the effect of alvimopan on the recovery of bowel function as determined by time to first bowel movement in patients undergoing posterior spinal fusion. The effect size calculated may guide a larger, multicenter randomized controlled study. Time was measured from wound closure to bowel movement.|14 days or until hospital discharge whichever occurs first||||Hours||Standard Deviation|Mean
2595781|NCT02218164|Secondary|Occurence of Treatment Related Serious Adverse Events (SAEs)|Number of participants with treatment emergent SAEs, overall and per Event Description.|1 year|All participants|||Participants|||Count of Participants
2595782|NCT02218164|Secondary|Overall Survival (OS)|OS: The time from registration to death or date of last contact. Participants with overall survival at 1 year. Kaplan-Meier estimator will be utilized.|1 year|All participants who received study treatment.|||Participants|||Count of Participants
2595783|NCT02218164|Secondary|Progression Free Survival (PFS)|PFS: Alive without RECIST progression. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|1 year|All participants|||months||95% Confidence Interval|Median
2595784|NCT02218164|Primary|Objective Response Rate (ORR)|ORR: Stable Disease (SD); Partial Response (PR); Complete Response (CR). Response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR: disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|9 weeks per participant|All participants|||Participants|||Count of Participants
2595785|NCT02218008|Secondary|Number of Subjects With Adverse Events (AEs)||5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)|The safety population includes all subjects who were randomized and received at least 1 dose of study drug.|||Participants|||Count of Participants
2595786|NCT02218008|Secondary|Remission Rate|The proportion of subjects achieving remission, defined as a MADRS-10 score of ≤10 at the end of the efficacy period.|5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)|Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline MADRS-10 (or HAM-D17) assessment in the respective stage.|||Participants|||Count of Participants
2595787|NCT02218008|Secondary|Proportion of Patients Who Exhibited Treatment Response (MADRS-10)|The proportion of subjects demonstrating MADRS-10 treatment response, defined as a ≥ 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (week 5). The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.|5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)|Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline MADRS-10 assessment in the respective stage.|||Participants|||Count of Participants
2595788|NCT02218008|Primary|Change From Baseline to End of Treatment in the MADRS-10|The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.|5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)|Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline MADRS-10 assessment in the respective stage.|||Units on a scale||Standard Error|Least Squares Mean
2595837|NCT02217878|Secondary|Time to Maximum Concentration for AR-C124910XX|Time to maximum concentration (Tmax) for AR-C124910XX|12 hours||||hours||Inter-Quartile Range|Median
2595789|NCT02218008|Primary|Change in MADRS-10 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)|The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.|5-6 Weeks (5 weeks for Stage 1 and 6 weeks for Stage 2)|Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline MADRS-10 assessment in the respective stage.|||Units on a scale||Standard Error|Least Squares Mean
2595790|NCT02218008|Primary|Change in Montgomery Asberg Depression Rating Scale (MADRS)-6 Score Using Average of Changes From Baseline to Week 3 Through the End of Treatment Period (Week 5 for Stage 1, Week 6 for Stage 2)|The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of MDD symptoms. The MADRS-6 scale is a subset of the MADRS-10 scale, comprised of the following individual questionnaire items: Apparent Sadness, Reported Sadness, Inner Tension, Lassitude, Inability to Feel, and Pessimistic Thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).|Baseline and 5 weeks (Stage 1) and baseline and 6 weeks (Stage 2), combined together for the overall estimate of treatment effect|Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline MADRS assessment in the respective stage.|||Units on a scale||Standard Error|Least Squares Mean
2595791|NCT02217982|Other Pre-specified|Number of Participants With Pre-Existing GI Conditions|The tertiary objective is to gather further data regarding pre-existing conditions (GE reflex, gastric bypass, stomach ulcer, etc) and their possible relationship to GI symptoms when initiating DMF.|7 Weeks|||||||
2595792|NCT02217982|Secondary|Diarrhea Reduction|The secondary objective is to assess the reduction in diarrhea in the treatment group compared to the control.|7 Weeks|Not enough patients qualified and the study was terminated early.||||||
2595793|NCT02217982|Primary|Reported GI Symptoms|The primary endpoint will be severity of GI events as measured by the MAGIS scale for subjects in the treatment arm compared to the standard therapy arm.|7 Weeks|Trial was shut down early as not enough patients qualified with GI symptoms their first 2 weeks after initiating DMF therapy||||||
2595794|NCT02217904|Secondary|Apparent Terminal Half-Life (t1/2) of Islatravir in Plasma|Blood was collected for the determination of apparent terminal t1/2 of islatravir in plasma.|Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had apparent terminal t1/2 of islatravir in plasma data available, and were evaluable for the outcome measure.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2595795|NCT02217904|Secondary|Time to Maximum Plasma Concentration (Tmax) of Islatravir|Blood was collected for the determination of Tmax of islatravir in plasma.|Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had plasma Tmax of islatravir data available, and were evaluable for the outcome measure.|||Hour||Full Range|Median
2595796|NCT02217904|Secondary|Maximum Plasma Concentration (Cmax) of Islatravir|Blood was collected for the determination of Cmax of islatravir in plasma.|Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had plasma Cmax of islatravir data available, and were evaluable for the outcome measure.|||nM||Geometric Coefficient of Variation|Geometric Mean
2595797|NCT02217904|Secondary|Area Under the Plasma Concentration-Time Curve of Islatravir From Time 0 to 168 Hours (AUC0-168hr)|Blood was collected for the determination of AUC0-168hr of islatravir in plasma.|Predose and at 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, and 96 hours after islatravir administration. Value at 168 hours was extrapolated.|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had plasma AUC-168hr of islatravir data available, and were evaluable for the outcome measure.|||hr*nM||Geometric Coefficient of Variation|Geometric Mean
2595798|NCT02217904|Secondary|Apparent Terminal Half-Life (t1/2) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells|Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine apparent terminal t1/2.|4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had apparent terminal t1/2 of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2595799|NCT02217904|Secondary|Time to Maximum Concentration (Tmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells|Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine TMax.|4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had Tmax of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.|||Hour||Full Range|Median
2595800|NCT02217904|Secondary|Concentration of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells at 168 Hours Post-Dose (C168hr)|Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine C168hr.|168 hours after islatravir administration|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had C168hr of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.|||pmol/10^6 cells||Geometric Coefficient of Variation|Geometric Mean
2595838|NCT02217878|Secondary|Time to Maximum Concentration for Ticagrelor|Time to maximum concentration (Tmax) for ticagrelor|12 hours||||hours||Inter-Quartile Range|Median
2595839|NCT02217878|Secondary|Maximum Concentration of AR-C124910XX|Maximum concentration (Cmax) of AR-C124910XX|12 hours||||ng/mL||Inter-Quartile Range|Median
2595801|NCT02217904|Secondary|Maximum Concentration (Cmax) of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells|Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine Cmax.|4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had Cmax of islatravir triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.|||pmol/10^6 cells||Geometric Coefficient of Variation|Geometric Mean
2595802|NCT02217904|Secondary|Area Under the Concentration-Time Curve of Islatravir Triphosphate in Peripheral Blood Mononuclear Cells From Time 0 to 168 Hours (AUC0-168hr)|Blood was collected to measure intracellular islatravir triphosphate concentration in peripheral blood mononuclear cells and determine AUC0-168hr.|4, 12, 24, 96, 120, 144, and 168 hours after islatravir administration. Value at predose was inferred from plasma predose sample.|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had AUC0-168hr of triphosphate in peripheral blood mononuclear cells data available, and were evaluable for the outcome measure.|||hr*pmol/10^6 cells||Geometric Coefficient of Variation|Geometric Mean
2595803|NCT02217904|Primary|Number of Participants With One or More Adverse Events|An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Up to 21 days post-dose|All participants who received at least one dose of investigational drug|||Participants|||Count of Participants
2595804|NCT02217904|Primary|Change From Baseline in Plasma HIV-1 RNA at 168 Hours Post-Dose|Plasma HIV-1 RNA was measured using the Roche COBAS Ampliprep/COBAS TaqMan HIV-1 test v.2.0, which has a linear range from 20 to 10,000,000 copies/mL. The lower limit of detection has 100% specificity at 20 copies/mL. Additionally, the test increases the probability of detection and expands coverage by targeting two highly conserved regions of the HIV-1 genome to compensate for the possibility of mutations or mismatches.|Baseline and 168 hours (7 days) post-dose|The analysis population consisted of all participants who received at least 1 dose of study treatment, were compliant with study procedures, had available plasma HIV-1 RNA data at baseline and 168 hours post-dose, and were evaluable for the outcome measure.|||log10 copies/mL||95% Confidence Interval|Least Squares Mean
2595805|NCT02217878|Secondary|Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With VerifyNow|Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity (HPR) Evaluated With VerifyNow|12 hours|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||hours||Inter-Quartile Range|Median
2595806|NCT02217878|Secondary|Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With MEA|Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity (HPR) Evaluated With MEA|12 hours|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||hours||Inter-Quartile Range|Median
2595807|NCT02217878|Secondary|Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity Evaluated With VASP|Time to Reach Platelet Reactivity Below the Cut-off Value for High Platelet Reactivity (HPR) Evaluated With VASP|12 hours||||hours||Inter-Quartile Range|Median
2595808|NCT02217878|Secondary|Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With VerifyNow|Percentage of Patients With High Platelet Reactivity (HPR) After the Loading Dose of Ticagrelor Assessed With VerifyNow|2 hours|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||Percentage of Patients With HPR|||Number
2595809|NCT02217878|Secondary|Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With MEA|Percentage of Patients With High Platelet Reactivity (HPR) After the Loading Dose of Ticagrelor Assessed With MEA|2 hours|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||Percentage of Patients With HPR|||Number
2595810|NCT02217878|Secondary|Percentage of Patients With High Platelet Reactivity After the Loading Dose of Ticagrelor Assessed With VASP|Percentage of Patients With High Platelet Reactivity (HPR) After the Loading Dose of Ticagrelor Assessed With VASP|2 hours||||Percentage of Patients With HPR|||Number
2595811|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|12 hours post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||P2Y12 Reaction Units||Inter-Quartile Range|Median
2595812|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|6 hours post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||P2Y12 Reaction Units||Inter-Quartile Range|Median
2595813|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|4 hours post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||P2Y12 Reaction Units||Inter-Quartile Range|Median
2595814|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|3 hours post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||P2Y12 Reaction Units||Inter-Quartile Range|Median
2595815|NCT02217878|Secondary|P2Y12 Reaction Units Assessed by VerifyNow|P2Y12 Reaction Units (PRU) Assessed by VerifyNow (cut-off value for high platelet reactivity: PRU >208)|2 hours post ticagrelor dose|In line with the study protocol, VerifyNow pharmacodynamic evaluation involved >30% of the overall study population.|||P2Y12 Reaction Units||Inter-Quartile Range|Median
2595840|NCT02217878|Secondary|Maximum Concentration of Ticagrelor|Maximum concentration (Cmax) of ticagrelor|12 hours||||ng/mL||Standard Deviation|Mean
2595819|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|12 hours post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
2595820|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|6 hours post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
2595821|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|4 hours post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
2595822|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|3 hours post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
2595823|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|2 hours post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
2595824|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|1 hour post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
2595825|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|30 minutes post ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
2595826|NCT02217878|Secondary|Platelet Arbitrary Aggregation Units Assessed by Multiple Electrode Aggregometry|Platelet reactivity assessed by Multiple Electrode Aggregometry (cut-off value for high platelet reactivity: AUC >46 Platelet Arbitrary Aggregation Units)|prior to the initial ticagrelor dose|According to the study protocol multiple electrode aggregometry pharmacodynamic evaluation was performed in all patients except for those treated with glycoprotein (GP) IIb/IIIa receptor inhibitors.|||Platelet Arbitrary Aggregation Units||Inter-Quartile Range|Median
2595827|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|12 hours post ticagrelor dose||||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
2595828|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|6 hours post ticagrelor dose||||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
2595829|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|4 hours post ticagrelor dose||||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
2595830|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|3 hours post ticagrelor dose||||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
2595831|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|2 hours post ticagrelor dose||||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
2595832|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|1 hour post ticagrelor dose||||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
2595833|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|30 minutes post ticagrelor dose||||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
2595834|NCT02217878|Secondary|Platelet Reactivity Index Assessed by VASP Assay|Platelet Reactivity Index (PRI) evaluated by VASP assay (cut-off value for high platelet reactivity: PRI >50%)|prior to the initial ticagrelor dose||||Platelet Reactivity Index (%)||Inter-Quartile Range|Median
2595835|NCT02217878|Secondary|Area Under the Plasma Concentration-time Curve for AR-C124910XX (AUC 0-6)|Exposure to ticagrelor metabolite during the first 6 hours after ticagrelor loading dose|prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose||||ng*h/mL||Inter-Quartile Range|Median
2595836|NCT02217878|Secondary|Area Under the Plasma Concentration-time Curve for Ticagrelor (AUC 0-6h)|Exposure to ticagrelor during the first 6 hours after ticagrelor loading dose|prior to the initial dose and 30min, 1h, 2h, 3h, 4h, 6h post dose||||ng*h/mL||Inter-Quartile Range|Median
2595843|NCT02217800|Primary|The Number of Patients Who Achieve a Trough Human Growth Hormone (hGH) Concentration of <2.5µg/L During the Last 12 Hours of the 23 Hour Profile Following Each Study Treatment.||23 hours following each treatment||||participants with trough hGH < 2.5 µg/mL|||Number
2595844|NCT02217618|Primary|Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) of LY2409021||Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose|All participants who received a dose of study drug and had evaluable Tmax data.|||hours||Full Range|Median
2595845|NCT02217618|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021||Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose|All participants who received a dose of study drug and had evaluable Cmax data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2595846|NCT02217618|Primary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021|Area under the concentration versus time curve from zero to infinity (AUC[0-inf]) of LY2409021 is presented.|Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose|All participants who received a dose of study drug and had evaluable AUC(0-inf) data.|||nanogram*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2595847|NCT02217566|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant who will receive study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.|Up to 4 years|The safety population included all participants who received at least 1 dose of any study drug.|||Participants|||Count of Participants
2595848|NCT02217566|Secondary|Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Interference Score|The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain interference score is mean value for the 7 BPI-SF questions (questions inquiring about the extent of interference with activities by pain) where the extent is ranked from 0 (does not interfere) to 10 (completely interferes). Pain interference progression was defined as an increase in score of 50% or greater from baseline without decrease in analgesic use.|Up to 2 years|The efficacy population included all eligible participants who received at least one dose of any study drug and with at least 2 BPI-SF assessments after baseline.|||Percentage of participants|||Number
2595849|NCT02217566|Secondary|Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Severity Score|The BPI-SF is a publicly available instrument to assess the pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. Pain severity score is a mean value for BPI-SF questions 3, 4, 5 and 6 (questions inquiring about the extent of pain, where the extent is ranked from 0 [no pain] to 10 [pain as bad as you can imagine]). Pain severity progression was defined as an increase in score of 30% or greater from baseline without decrease in analgesic use.|Up to 2 years|The efficacy population included all eligible participants who received at least one dose of any study drug and with at least 2 BPI-SF assessments after baseline.|||Percentage of participants|||Number
2595850|NCT02217566|Secondary|Overall Survival|Overall survival was defined as the time from date of the first dose of abiraterone acetate to the date of death due to any cause. For participants who did not die until the time of analysis, survival time was censored at the time of last contact alive.|Up to 4 years|The efficacy population included all eligible participants who received at least one dose of any study drug.|||Months||95% Confidence Interval|Median
2595851|NCT02217566|Secondary|Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response|The PSA response according to Prostate Specific Antigen Working Group 3 criteria was defined as at least 50% decrease in PSA level from Baseline.|Week 12 to any time up to 2 years|The efficacy population included all eligible participants who received at least one dose of any study drug.|||Percentage of participants||95% Confidence Interval|Number
2595852|NCT02217566|Primary|Time to Prostate-specific Antigen (PSA) Progression|Time to PSA progression was calculated from date of enrollment to the date of first documentation of PSA progression. As per Prostate Cancer Clinical Trials Working Group (PCWG2) criteria, PSA progression was defined as greater than or equal to (>=) 25 percent (%) and >=2 nanogram/milliliter (ng/mL) after 12 weeks (in case of no decline in PSA from Baseline), or first PSA increase that is >=25% and >=2 ng/mL above the nadir, and which was confirmed by a second value 3 or more weeks later (in case of decline of PSA from Baseline).|Up to 2 years|The efficacy population included all eligible participants who received at least one dose of any study drug.|||Months||95% Confidence Interval|Median
2595853|NCT02217527|Secondary|Cognitive Function on Continuous Performance Task (CPT) for Those With CO<10 During First Assessment Day (Mon) of Attempt to Quit Smoking During Both JNJ and Plac Quit Periods|This measure of cognitive performance (mean of median speed of correct responding on computer keyboard to letters and numbers) was assessed only on Monday (day 1) of the 0-5 days during each drug/placebo condition. Data only from those shown to have CO<10 ppm were analyzed, to confirm responding during abstinence while on drug/placebo condition. Cognitive testing consisted of standard Continuous Performance Task (CPT), on active JNJ and on placebo phases. This measure is assessed to determine potential mechanism of drug efficacy in relieving disrupted cognitive processing function caused by tobacco deprivation and withdrawal.|first day during quit week on JNJ, and during quit week on placebo.|Only those participants able to quit or sharply limit smoking exposure during both JNJ and the placebo phases of testing, defined as those with CO<10 during both tests of cognitive performance when tobacco abstinent.|||ms time of correct responding||Standard Deviation|Mean
2595884|NCT02217475|Secondary|Change From Baseline in Morphometric Quantitative Fat Content on Liver Biopsy at Year 2|The morphometric quantitative fat content was done to find out the amount of fat accumulated in the liver. A liver biopsy was performed to determine percent fat area, at Year 2. A negative change from Baseline indicates improvement.|Year 2|FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percent fat area||Standard Deviation|Mean
2595854|NCT02217527|Secondary|Minnesota Nicotine Withdrawal Scale (MNWS) During Attempt to Quit on Active JNJ Drug and on Placebo|"Severity of withdrawal symptoms will be assessed with standard self-report measure of Minnesota Nicotine Withdrawal Scale (MNWS) each quit day during one week only on active JNJ, and each quit day during one week on placebo. Ratings are made on 0-100 visual analog scale, with 0=not at all to 100=very much, and are averaged to create a total score also ranging from 0-100. Higher scores indicate more severe withdrawal."|only on days quit while on JNJ or on placebo|Withdrawal severity on quit days for smokers interested in quitting soon, while attempting to quit briefly during one week on active JNJ or one week on placebo.|||units on a scale||Standard Deviation|Mean
2595855|NCT02217527|Primary|Quit Status|"Complete abstinence from smoking for 24 hr is counted as a quit day and is assessed daily from Mon-Fri for just one week, on the JNJ active drug and one week on placebo. This same Mon-Fri procedure for one week (only) is done for both drug phases. Total outcome in each drug condition therefore is number of quit days out of the five assessment days (range 0-5)."|up to one week each drug phase (0-5)|Smokers trying to quit each day during 5-day period on active JNJ, and then during 5-day period on placebo, in crossover design.|||number of days quit||Standard Deviation|Mean
2595856|NCT02217475|Secondary|Change From Baseline in Tricep Skinfold Thickness at Months 15, 18 and 24|A negative change from Baseline represents decreased Tricep Skinfold Thickness.|Baseline (Day 1) to Months 15, 18 and 24|Safety Analysis Set Year 2 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||mm||Standard Deviation|Mean
2595857|NCT02217475|Secondary|Change From Baseline in Tricep Skinfold Thickness at Months 3, 6 and 12|A negative change from Baseline represents decreased Tricep Skinfold Thickness.|Baseline (Day 1) to Months 3, 6 and 12|Safety Analysis Set Year 1 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||mm||Standard Deviation|Mean
2595858|NCT02217475|Secondary|Change From Baseline in Forearm Circumference at Months 15, 18 and 24|A negative change from Baseline represents decreased forearm circumference.|Baseline (Day 1) to Months 15, 18 and 24|Safety Analysis Set Year 2 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||cm||Standard Deviation|Mean
2595859|NCT02217475|Secondary|Change From Baseline in Forearm Circumference at Months 3, 6 and 12|A negative change from Baseline represents decreased forearm circumference.|Baseline (Day 1) to Months 3, 6 and 12|Safety Analysis Set Year 1 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||cm||Standard Deviation|Mean
2595860|NCT02217475|Secondary|Change From Baseline in Hip Circumference at Months 15, 18 and 24|A negative change from Baseline represents decreased hip circumference.|Baseline (Day 1) to Months 15, 18 and 24|Safety Analysis Set Year 2 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||cm||Standard Deviation|Mean
2595861|NCT02217475|Secondary|Change From Baseline in Hip Circumference at Months 3, 6 and 12|A negative change from Baseline represents decreased hip circumference.|Baseline (Day 1) to Months 3, 6 and 12|Safety Analysis Set Year 1 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||cm||Standard Deviation|Mean
2595862|NCT02217475|Secondary|Change From Baseline in Waist Circumference at Months 15, 18 and 24|A negative change from Baseline represents decreased in waist circumference.|Baseline (Day 1) to Months 15, 18 and 24|Safety Analysis Set Year 2 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||cm||Standard Deviation|Mean
2595863|NCT02217475|Secondary|Change From Baseline in Waist Circumference at Months 3, 6 and 12|A negative change from Baseline represents decreased in waist circumference.|Baseline (Day 1) to Months 3, 6 and 12|Safety Analysis Set Year 1 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||cm||Standard Deviation|Mean
2595864|NCT02217475|Secondary|Change From Baseline in Body Mass Index (BMI) at Months 15, 18 and 24|The body mass index is a value derived from the mass (weight in kgs) and height (in centimeters) of an individual and is calculated as the body mass divided by the square of the body height. A negative change from Baseline represents decreased BMI.|Baseline (Day 1) to Months 15, 18 and 24|Safety Analysis Set Year 2 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||kg/m^2||Standard Deviation|Mean
2595865|NCT02217475|Secondary|Change From Baseline in Body Mass Index (BMI) at Months 3, 6 and 12|The body mass index is a value derived from the mass (weight in kgs) and height (in centimeters) of an individual and is calculated as the body mass divided by the square of the body height. A negative change from Baseline represents decreased BMI.|Baseline (Day 1) to Months 3, 6 and 12|Safety Analysis Set Year 1 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||kg/m^2||Standard Deviation|Mean
2595866|NCT02217475|Secondary|Change From Baseline in Weight at Months 15, 18 and 24|A negative change from Baseline represents decreased weight.|Baseline (Day 1) to Months 15, 18 and 24|Safety Analysis Set Year 2 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||kg||Standard Deviation|Mean
2595867|NCT02217475|Secondary|Change From Baseline in Weight at Months 3, 6 and 12|A negative change from Baseline represents decreased weight.|Baseline (Day 1) to Months 3, 6 and 12|Safety Analysis Set Year 1 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||kg||Standard Deviation|Mean
2597520|NCT02196714|Primary|Vd/F|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||L||Full Range|Mean
2595868|NCT02217475|Secondary|Change From Baseline in Biomarkers of Hepatocyte Apoptosis: Caspase Cleaved (CK-18 [M-30]) Levels and Total M-65 (CK-18 [M-65]) Levels at Months 15, 18 and 24|Caspase-cleaved cytokeratin levels (CK18M30) and total M-65 (CK-18 [M-65]) were measured as biomarkers of hepatocyte apoptosis. A negative change from Baseline indicates decreased hepatocyte apoptosis.|Baseline (Month 0) to Months 15, 18 and 24|FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||U/L||Standard Deviation|Mean
2595869|NCT02217475|Secondary|Change From Baseline in Biomarkers of Hepatocyte Apoptosis: Caspase Cleaved (CK-18 [M-30]) Levels and Total M-65 (CK-18 [M-65]) Levels at Months 3, 6 and 12|Caspase-cleaved cytokeratin levels (CK18M30) and total M-65 (CK-18 [M-65]) were measured as biomarkers of hepatocyte apoptosis. A negative change from Baseline indicates decreased hepatocyte apoptosis.|Baseline (Month 0) to Months 3, 6 and 12|FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||U/L||Standard Deviation|Mean
2595870|NCT02217475|Secondary|Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Enhanced Liver Fibrosis Test (ELF) Score at Months 18 and 24|The markers of fibrosis assessed in this test comprised hyaluronic acid (CHA), tissue inhibitor of metalloproteinase (CTIMP1) and procollagen III N-terminal peptide (CP3NP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during activation of the stellate cell. The ELF tests were performed on Centaur device and the composite score was calculated as follows: ELF score = 2.278 + 0.851 ln(CHA) + 0.751 ln (CP3NP) + 0.394 ln(CTIMP1). ELF score < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis. A negative change from Baseline indicates decreased fibrosis.|Baseline (Month 0) to Months 18 and 24|FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||ng/mL||Standard Deviation|Mean
2595871|NCT02217475|Secondary|Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Enhanced Liver Fibrosis Test (ELF) Score at Months 6 and 12|The markers of fibrosis assessed in this test comprised hyaluronic acid (CHA), tissue inhibitor of metalloproteinase (CTIMP1) and procollagen III N-terminal peptide (CP3NP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during activation of the stellate cell. The ELF tests were performed on Centaur device and the composite score was calculated as follows: ELF score = 2.278 + 0.851 ln(CHA) + 0.751 ln (CP3NP) + 0.394 ln(CTIMP1). ELF score < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis. A negative change from Baseline indicates decreased fibrosis.|Baseline (Month 0) to Months 6 and 12|FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||ng/mL||Standard Deviation|Mean
2595872|NCT02217475|Secondary|Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: NAFLD Fibrosis Score (NFS) at Months 15, 18 and 24|NFS is calculated using formula: NFS = -1.675 + 0.037 * age (years) + 0.094 * Body mass index (BMI) (kg/m^2) + 1.13 * Impaired fasting glucose (IFG)/diabetes (yes = 1, no = 0) + 0.99 * Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ratio - 0.013 × platelet (*10^9/L) - 0.66 * albumin (g/dL). A negative change from Baseline indicates decreased fibrosis.|Baseline (Month 0) to Months 15, 18 and 24|FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||ng/mL||Standard Deviation|Mean
2595873|NCT02217475|Secondary|Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Nonalcoholic Fatty Liver Disease (NAFLD) Fibrosis Score (NFS) at Months 3, 6 and 12|NFS is calculated using formula: NFS = -1.675 + 0.037 * age (years) + 0.094 * Body mass index (BMI) (kg/m^2) + 1.13 * Impaired fasting glucose (IFG)/diabetes (yes = 1, no = 0) + 0.99 * Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ratio - 0.013 × platelet (*10^9/L) - 0.66 * albumin (g/dL). A negative change from Baseline indicates decreased fibrosis.|Baseline (Month 0) to Months 3, 6 and 12|FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||ng/mL||Standard Deviation|Mean
2595874|NCT02217475|Secondary|Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Hyaluronic Acid at Months 18 and 24|Hyaluronic acid is a non-invasive hepatic fibrosis marker. A positive change from Baseline indicates increased fibrosis.|Baseline (Month 0) to Months 18 and 24|FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||ng/mL||Standard Deviation|Mean
2595875|NCT02217475|Secondary|Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Hyaluronic Acid at Months 6 and 12|Hyaluronic acid is a non-invasive hepatic fibrosis marker. A negative change from Baseline indicates decreased fibrosis.|Baseline (Month 0) to Months 6 and 12|FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||ng/mL||Standard Deviation|Mean
2595885|NCT02217475|Secondary|Change From Baseline in Morphometric Quantitative Fat Content on Liver Biopsy at Year 1|The morphometric quantitative fat content was done to find out the amount of fat accumulated in the liver. A liver biopsy was performed to determine percent fat area, at Year 1. A negative change from Baseline indicates improvement.|Year 1|FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percent fat area||Standard Deviation|Mean
2595876|NCT02217475|Secondary|Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Fibrosis-4 (FIB-4) at Months 15, 18 and 24|Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: FIB-4 = (Age [years] x AST [U/L]) / (platelets [10^9/L] x (square root of ALT [U/L])). A FIB-4 index of < 1.45 indicated no or moderate fibrosis and an index of > 3.25 indicated extensive fibrosis/cirrhosis. A positive change from Baseline indicates increased fibrosis.|Baseline (Month 0) to Months 15, 18 and 24|FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||ratio||Standard Deviation|Mean
2595877|NCT02217475|Secondary|Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Fibrosis-4 (FIB-4) at Months 3, 6 and 12|Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: FIB-4 = (Age [years] x AST [U/L]) / (platelets [10^9/L] x (square root of ALT [U/L])). A FIB-4 index of < 1.45 indicated no or moderate fibrosis and an index of > 3.25 indicated extensive fibrosis/cirrhosis. A positive change from Baseline indicates increased fibrosis.|Baseline (Month 0) to Months 3, 6 and 12|FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||ratio||Standard Deviation|Mean
2595878|NCT02217475|Secondary|Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Aspartate Aminotransferase to Platelet Count Ratio Index (APRI) at Months 15, 18 and 24|APRI is the ratio of aspartate aminotransferase (AST) to platelet count. It is calculated using formula, APRI = (AST level [/ULN] / platelet counts [10^9/L]) * 100. An APRI index of <=0.50 indicated the absence of significant fibrosis and an index of > 1.50 indicated the presence of significant fibrosis. A negative change from Baseline indicates decreased fibrosis.|Baseline (Month 0) to Months 15, 18 and 24|FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||ratio||Standard Deviation|Mean
2595879|NCT02217475|Secondary|Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Aspartate Aminotransferase to Platelet Count Ratio Index (APRI) at Months 3, 6 and 12|APRI is the ratio of aspartate aminotransferase (AST) to platelet count. It is calculated using formula, APRI = (AST level [/ULN] / platelet counts [10^9/L]) * 100. An APRI index of <=0.50 indicated the absence of significant fibrosis and an index of > 1.50 indicated the presence of significant fibrosis. A negative change from Baseline indicates decreased fibrosis.|Baseline (Month 0) to Months 3, 6 and 12|FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.|||ratio||Standard Deviation|Mean
2595880|NCT02217475|Secondary|Change From Baseline in Portal Inflammation Grade on Liver Biopsy at Year 2|Portal inflammation on liver biopsy was graded from 0 to 4 where 0= None, 1= Mild, 2= Moderate, and 3= Marked. A positive change from Baseline indicates worsening.|Baseline (Day 1) to Year 2|FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
2595881|NCT02217475|Secondary|Change From Baseline in Portal Inflammation Grade on Liver Biopsy at Year 1|Portal inflammation on liver biopsy was graded from 0 to 4 where 0= None, 1= Mild, 2= Moderate, and 3= Marked. A positive change from Baseline indicates worsening.|Baseline (Day 1) to Year 1|FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
2595882|NCT02217475|Secondary|Change From Baseline in Histologic Fibrosis Stage (NASH CRN System and Ishak Scale Score) at Year 2|The participant's histologic fibrosis stage was determined using the NASH CRN system and Ishak scale score assessment at Year 1. The evaluation of fibrosis stage associated with NASH was based on the NASH CRN Fibrosis Staging System which was scaled from 0 to 4 where, 0=None to 4=Cirrhosis. The histologic fibrosis stage based on the Ishak assessment was divided into 1 to 6 stages. Fibrosis was staged with the Ishak scale (ranging from 0=No fibrosis to 6=Cirrhosis). A negative change from Baseline indicates improvement.|Baseline (Day 1) to Year 2|FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
2595883|NCT02217475|Secondary|Change From Baseline in Histologic Fibrosis Stage (NASH CRN System and Ishak Scale Score) at Year 1|The participant's histologic fibrosis stage was determined using the NASH CRN system and Ishak scale score assessment at Year 1. The evaluation of fibrosis stage associated with NASH was based on the NASH CRN Fibrosis Staging System which was scaled from 0 to 4 where, 0=None to 4=Cirrhosis. The histologic fibrosis stage based on the Ishak assessment was divided into 1 to 6 stages. Fibrosis was staged with the Ishak scale (ranging from 0=No fibrosis to 6=Cirrhosis). A positive change from Baseline indicates worsening.|Baseline (Day 1) to Year 1|FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
2595918|NCT02217410|Primary|Mean AUClast Pharmacokinetic Parameter - Part I|Quantify pharmacokinetics of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods.|Day 1|The PK Analysis Set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data.|||day*ug/mL||Standard Deviation|Mean
2595886|NCT02217475|Secondary|Change From Baseline in Hepatic Tissue Fibrogenic Protein Alpha-Smooth Muscle Actin (α-SMA) at Year 2|The hepatic tissue fibrogenic protein α-SMA level was determined as percent α-SMA + area using α-SMA stain on liver biopsy at Year 2. A positive change from Baseline indicates worsening.|Baseline (Day 1) to Year 2|FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of α-SMA positive cells/area||Standard Deviation|Mean
2595887|NCT02217475|Secondary|Change From Baseline in Hepatic Tissue Fibrogenic Protein Alpha-Smooth Muscle Actin (α-SMA) at Year 1|The hepatic tissue fibrogenic protein α-SMA level was determined as percent α-SMA + area using α-SMA stain on liver biopsy at Year 1. A positive change from Baseline indicates worsening.|Baseline (Day 1) to Year 1|FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of α-SMA positive cells/area||Standard Deviation|Mean
2595888|NCT02217475|Secondary|Change From Baseline in Morphometric Quantitative Collagen on Liver Biopsy at Year 2|The morphometric quantitative collagen on liver biopsy was determined as percent collagen area (PCA) using Sirius red stain on liver biopsy at Year 2. A negative change from Baseline indicates improvement.|Year 2|FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percent collagen area||Standard Deviation|Mean
2595889|NCT02217475|Secondary|Change From Baseline in Morphometric Quantitative Collagen on Liver Biopsy at Year 1|The morphometric quantitative collagen on liver biopsy was determined as percent collagen area (PCA) using Sirius red stain on liver biopsy at Year 1. A negative change from Baseline indicates improvement.|Year 1|FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percent collagen area||Standard Deviation|Mean
2595890|NCT02217475|Secondary|Number of Participants With Resolution of NASH Using a Modified Definition Based on Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 2|Resolution of NASH was defined as having no hepatocellular ballooning (grade 0) and minimal to no lobular inflammation (grade 1 or 0) with no concurrent worsening of fibrosis stage (worsening defined as progression of NASH CRN fibrosis stage).|Year 2|FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations.|||Participants|||Count of Participants
2595891|NCT02217475|Secondary|Number of Participants With Resolution of NASH Using a Modified Definition Based on Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 1|Resolution of NASH was defined as having no hepatocellular ballooning (grade 0) and minimal to no lobular inflammation (grade 1 or 0) with no concurrent worsening of fibrosis stage (worsening defined as progression of NASH CRN fibrosis stage).|Year 1|FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations.|||Participants|||Count of Participants
2595892|NCT02217475|Secondary|Number of Participants With Hepatic Histological Improvement With a Minimum 2-Point Improvement in NAS With at Least a 1-point Improvement in More Than 1 Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 2|Hepatic histological improvement in NAS was defined as a decrease (improvement) in NAS by ≥ 2 with at least a 1-point reduction in either steatosis, lobular inflammation or hepatocellular ballooning and with no concurrent worsening of fibrosis stage. The NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8 with the higher score indicating more aggressive disease. Worsening was defined as progression of NASH CRN fibrosis stage.|Year 2|FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations.|||Participants|||Count of Participants
2595893|NCT02217475|Secondary|Number of Participants With Hepatic Histological Improvement With a Minimum 2-Point Improvement in NAS With at Least a 1-Point Improvement in More Than 1 Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 1|Hepatic histological improvement in NAS was defined as a decrease (improvement) in NAS by ≥ 2 with at least a 1-point reduction in either steatosis, lobular inflammation or hepatocellular ballooning and with no concurrent worsening of fibrosis stage. The NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8 with the higher score indicating more aggressive disease. Worsening was defined as progression of NASH CRN fibrosis stage.|Year 1|FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations.|||Participants|||Count of Participants
2595894|NCT02217475|Secondary|Change From Baseline in the 3 Categorical Features of NAS (Steatosis, Lobular Inflammation, Hepatocellular Ballooning) at Year 2|NAS was calculated using the following 3 categorical features: steatosis which was scaled from 0-3 (steatosis score is defined as 0= <5%, 1= 5 - 33%, 2= >33 - 66%, and 3= >66%), lobular inflammation which was scaled from 0-3 (lobular inflammation score defined as 0= no foci, 1= < 2 foci/200x, 2= 2-4 foci/200x, and 3= > 4 foci/200x), and hepatocellular ballooning which was scaled from 0-2 (hepatocellular ballooning score is defined as 0=none, 1=few balloon cells, 2=many cells/prominent ballooning). A negative change from Baseline indicates improvement.|Year 2|FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
2595919|NCT02217410|Primary|Mean Tmax Pharmacokinetic Parameter - Part I|Quantify pharmacokinetics of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods.|Day 1|The PK Analysis Set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data.|||day||Full Range|Median
2595895|NCT02217475|Secondary|Change From Baseline in the 3 Categorical Features of NAS (Steatosis, Lobular Inflammation, Hepatocellular Ballooning) at Year 1|NAS was calculated using the following 3 categorical features: steatosis which was scaled from 0-3 (steatosis score is defined as 0= <5%, 1= 5 - 33%, 2= >33 - 66%, and 3= >66%), lobular inflammation which was scaled from 0-3 (lobular inflammation score defined as 0= no foci, 1= < 2 foci/200x, 2= 2-4 foci/200x, and 3= > 4 foci/200x), and hepatocellular ballooning which was scaled from 0-2 (hepatocellular ballooning score is defined as 0=none, 1=few balloon cells, 2=many cells/prominent ballooning). A negative change from Baseline indicates improvement.|Year 1|FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
2595896|NCT02217475|Secondary|Number of Participants With Hepatic Histological Improvement in NAS at Year 2|Hepatic histological improvement in NAS at Year 2 was defined as a decrease (improvement) in NAS by ≥ 2 with at least a 1-point reduction in either lobular inflammation or hepatocellular ballooning and with no concurrent worsening of fibrosis stage. The NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8 with the higher score indicating more aggressive disease.|Year 2|Full Analysis Set (FAS) in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations.|||Participants|||Count of Participants
2595897|NCT02217475|Secondary|Number of Participants With Clinically Abnormal in Electrocardiogram (ECG) Findings|A 12-lead ECG was performed. ECG results were reviewed by the Investigator for clinically notable abnormalities.|Years 1 and 2|Safety Analysis Set Year 1 and Year 2 included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2595898|NCT02217475|Secondary|Number of Participants With Clinical Laboratory Abnormalities|Grade 3-4 abnormal clinical laboratory values that occurred in ≥2% participants were reported. Criteria used for various parameters was:Fasting glucose Grade3:>250 - 500 mg/dL and Grade4: >500 mg/dL; Alanine aminotransferase(ALT)Grade3:>5.0 - 20.0 ×Upper Limit of Normal(ULN)and Grade4:>20.0 ×ULN; Aspartate aminotransferase(AST)Grade3: >5.0 - 20.0 ×ULN and Grade4: >20.0 ×ULN; Activated partial thromboplastin(APT)/Partial thromboplastin time(PTT)Grade3: >2.5×ULN; Triglycerides Grade3 >500 - 1000 mg/dL and Grade4: >1000 mg/dL; Gamma-glutamyl transferase(GGT)Grade3: >5.0 - 20.0 ×ULN and Grade4: >20.0 ×ULN; Creatine kinase Grade 3: >5.0 - 10.0 ×ULN and Grade4: >10.0 ×ULN; Uric acid Grade3:(ULN - 10 mg/dL; ULN - 0.59 mmol/L) and Grade4: >10 mg/dL; Amylase Grade3: >2.0 - 5.0 ×ULN and Grade4: >5.0 ×ULN; Lipase Grade3: >2.0 - 5.0 xULN and Grade4: >5.0 xULN; Phosphorus Grade3: <2.0 - 1.0 mg/dL and Grade4: <1.0 mg/dL and Absolute neutrophil Grade3: <1.0 - 0.5 × 109/L and Grade4: <0.5 × 109/L.|Years 1 and 2|Safety Analysis Set Year 1 and Year 2 included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2595899|NCT02217475|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs|Vital signs included blood pressure, temperature, heart rate, and respiration rate. Vital signs were reviewed by the Investigator for clinically significant changes.|Years 1 and 2|Safety Analysis Set Year 1 and Year 2 included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2595900|NCT02217475|Secondary|Number of Participants With Deaths, Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading Study Drug to Discontinuation|A TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 30 days after the discontinuation of the study medication. An SAE was defined as any untoward medical occurrence that, at any dose, results in death, was life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or was a congenital anomaly/birth defect.|Years 1 and 2|Safety Analysis Set Year 1 and Year 2 included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2595901|NCT02217475|Secondary|Number of Participants With Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 2|The evaluation of fibrosis stage associated with NASH was based on the NASH CRN Fibrosis Staging System which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis. As per NASH CRN system, no worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade.|Year 2|ITT analysis set Year 2 included all participants who have an evaluable year 1 biopsy and who received at least one dose of study drug during Year 2 (after the 1 year biopsy).|||Participants|||Count of Participants
2595902|NCT02217475|Secondary|Number of Participants With Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 1|The evaluation of fibrosis stage associated with NASH was based on the NASH CRN Fibrosis Staging System which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis. As per NASH CRN system, no worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade.|Year 1|ITT population included all randomized participants regardless of starting treatment.|||Participants|||Count of Participants
2595903|NCT02217475|Secondary|Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 2|Complete resolution of steatohepatitis was defined as histopathologic interpretation of no fatty liver disease, or simple or isolated steatosis with no steatohepatitis. As per NASH CRN system, no worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade. The evaluation of fibrosis stage associated with NASH was based on the NASH CRN fibrosis staging system which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis.|Year 2|ITT population Year 2 included all participants who had an evaluable year 1 biopsy and received at least 1 dose of study drug during Year 2.|||Participants|||Count of Participants
2595904|NCT02217475|Secondary|Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 1|Complete resolution of steatohepatitis was defined as histopathologic interpretation of no fatty liver disease, or simple or isolated steatosis with no steatohepatitis. As per NASH CRN system, no worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade. The evaluation of fibrosis stage associated with NASH was based on the NASH CRN fibrosis staging system which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis.|Year 1|ITT population included all randomized participants regardless of starting treatment.|||Participants|||Count of Participants
2595905|NCT02217475|Secondary|Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage and Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 2|Complete resolution of steatohepatitis was defined as histopathologic interpretation of no fatty liver disease, or simple or isolated steatosis with no steatohepatitis. As per NASH CRN system, no worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade. The evaluation of fibrosis stage associated with NASH was based on the NASH CRN fibrosis staging system which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis.|Year 2|ITT population Year 2 included all participants who had an evaluable year 1 biopsy and received at least 1 dose of study drug during Year 2.|||Participants|||Count of Participants
2595906|NCT02217475|Secondary|Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage and Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 1|Complete resolution of steatohepatitis was defined as histopathologic interpretation of no fatty liver disease, or simple or isolated steatosis with no steatohepatitis. As per NASH CRN system, no worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade. The evaluation of fibrosis stage associated with NASH was based on the NASH CRN fibrosis staging system which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis.|Year 1|ITT population included all randomized participants regardless of starting treatment.|||Participants|||Count of Participants
2595907|NCT02217475|Primary|Number of Participant With Hepatic Histological Improvement in NAS by ≥ 2 Points With at Least 1-Point Reduction in Either Lobular Inflammation or Hepatocellular Ballooning and no Concurrent Worsening of Fibrosis at Year 1|Hepatic histological improvement in Nonalcoholic Fatty Liver Disease Activity Score (NAS) at Year 1 was defined as a decrease (improvement) in NAS by ≥ 2 with at least a 1-point reduction in either lobular inflammation or hepatocellular ballooning and with no concurrent worsening of fibrosis stage. The NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8 with the higher score indicating more aggressive disease. Evaluation of fibrosis stage was based on the nonalcoholic steatohepatitis clinical research network (NASH CRN) fibrosis staging system, which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis. Worsening of fibrosis stage was defined as progression of NASH CRN fibrosis stage.|Year 1|Intent-to-treat (ITT) population included all randomized participants regardless of starting treatment.|||Participants|||Count of Participants
2595908|NCT02217436|Secondary|Parent Survey|Parent rating of own anxiety during the procedure Likert-based scale 1-5 (1 low/better, 5 high/worse)|Survey administered immediately following the laceration repair|Parent own anxiety survey|||score on a scale||Inter-Quartile Range|Median
2595909|NCT02217436|Primary|Observational Score Behavioral Distress Revised (OSBD-R)|Weighted average Observational Score Behavioral Distress Revised (OSBD-R) scored from videotapes of the entire laceration repair procedure Scale 0-23.5 (0 low/better, 23.5 high/worse)|Entire laceration repair procedure||||units on a scale||Inter-Quartile Range|Median
2595910|NCT02217410|Secondary|Total sCD40 Plasma Concentrations - Part II|To quantify the change from baseline and recovery of peripheral blood total soluble CD40|12 months|PD analysis set included all Patients in the Full Analysis set with available PD data and no protocol deviations with relevant impact on PD data.|||ng/mL||Standard Deviation|Mean
2595911|NCT02217410|Secondary|CFZ533 Plasma PK Concentrations - Part II|Quantify the systemic concentrations of CFZ533 in combination with MMF, CS, and tacrolimus in de novo renal transplant patients during the treatment and follow-up periods. A full pharmacokinetic analysis can be performed on the concentration-time data to evaluate the impact of renal transplantation on the various medications used in the treatment regimen.|throughout study period (day 84 to day 336)|The PK Analysis Set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data.|||ug/mL||Standard Deviation|Mean
2595912|NCT02217410|Secondary|eGFR - Part II|"Renal function as assessed by MDRD (Modification of Diet in Renal Disease) formula.~eGFR: Estimated glomerular filtration rate"|Day 1, Day 29, Day 337,|Safety analysis set included all patients that received at least one dose of study drug. For Part 2, all patients that received their transplant along with any patient who received study drug but had no transplant were combined.|||ml/min||90% Confidence Interval|Mean
2595913|NCT02217410|Secondary|Anti-CFZ533 Antibodies - Part II|To evaluate the immunogenicity of CFZ533 via the quantitative analysis of anti-CFZ533 antibodies|Baseline to end of study (screening, baseline, Day 141, Day 225, Day 309, Study Completion)|Safety analysis set included all patients that received at least one dose of study drug. For Part 2, all patients that received their transplant along with any patient who received study drug but had no transplant were combined.|||anti-CFZ533 antibodies|||Number
2595914|NCT02217410|Secondary|Anti-CFZ533 Antibodies - Part I|To evaluate the immunogenicity of CFZ533 via the quantitative analysis of anti-CFZ533 antibodies|Baseline to end of study|Safety analysis set included all patients that received at least one dose of study drug.|||anti-CFZ533 antibodies|||Number
2595915|NCT02217410|Secondary|Free CD40 and Total CD40 on B Cells - Part II|The magnitude and duration of peripheral blood CD40 occupancy. MESF: molecules of equivalent soluble fluorochrome|Baseline to end of study (Day 1/predose)|PD analysis set included all Patients in the Full Analysis set with available PD data and no protocol deviations with relevant impact on PD data.|||MESF||Standard Deviation|Mean
2595916|NCT02217410|Secondary|Total Soluble CD40 and Total Soluble CD154 Concentrations in Plasma - Part 1|To quantify the change from baseline and recovery of peripheral blood total soluble CD40 and total soluble CD154|Baseline to end of study (Day 1, Day 29, Day 337)|PD analysis set included all Patients in the Full Analysis set with available PD data and no protocol deviations with relevant impact on PD data.|||ng/ml||Standard Deviation|Mean
2595917|NCT02217410|Primary|Efficacy as Defined by the Frequency and Severity (Banff Classification) of Treated Biopsy Proven Acute Rejection (tBPAR) Adjudicated Data - Part II|"To assess the activity of the investigational arm as compared to the standard of care control arm in de novo renal transplant patients as measured by the frequency and severity of tBPAR as measured on the Banff classification scale.~An adjudication was performed on all on cause renal biopsies by an independent expert committee blinded to therapy."|3, 6, 9, and 12 months|PD analysis set included all Patients in the Full Analysis set with available PD data and no protocol deviations with relevant impact on PD data.|||events|||Number
2595920|NCT02217410|Primary|Mean Cmax Pharmacokinetic Parameter- Part I|Pharmacokinetics as defined by the systemic concentrations and Cmax of certain immunosuppressant medications used in Part I|Day 1|The PK Analysis Set included all patients with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received study drug and experienced no protocol deviations with relevant impact on PK data.|||ug/mL||Standard Deviation|Mean
2595921|NCT02217280|Primary|Circumferential Contrast Spread|"Number of study subjects who achieved circumferential contrast spread in the epidural space. Circumferential contrast spread is achieved when the contrast reaches all directions in the epidural space in the horizontal/axial plane.~This includes contrast spread in the anterior, posterior, medial and lateral directions (in relation to the spinal cord)."|1 hour||||Participants|||Count of Participants
2595922|NCT02217280|Primary|Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software.|Determine the relative efficacy (diagnostic and therapeutic) of cervical epidural injections based on injectate diffusion. We will measure (with post-injection MRI) how far the injection travels in the superoinferior directions (in cm) within in the epidural space.|1 hour||||cm||Standard Deviation|Mean
2595923|NCT02216812|Secondary|0-10 Ordinal Pain Score|Measure Description: The Ordinal Pain Scale measures the amount of pain on a scale from 0, no pain, to 10, worst possible pain. The investigators will compare the change in pain between the two cohorts after 6 weeks of treatment and 6 months after treatment.|Day 1 (baseline), 6 weeks, 6 months|Some subjects were lost to follow up between time of enrollment and 6 week and 6 month follow up|||units on a scale||Standard Deviation|Mean
2595924|NCT02216812|Secondary|PROMIS Upper Extremity - CAT|The Patient Reported Outcome Information System (PROMIS) Upper Extremity Computer Adaptive Test (CAT) is a computerized assessment measuring the physical function of the upper extremity. It is scored using a T-score, and the average is 50 for the U.S. population. In a given PROMIS, a T-score above 50 represents more of the measured variable than the average. For this variable, a T-score above 50 indicates greater physical function than the average population.|Day 1 (baseline), 6 weeks, 6 months|Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.|||T-score||Standard Deviation|Mean
2595925|NCT02216812|Secondary|Thumb Motion|Total active range of motion at the thumb combines active flexion at the metacarpo-phalangeal and interphalangeal joint, as well as palmar andabduction|Day 1 (baseline), 6 weeks|Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.|||Degrees||Standard Deviation|Mean
2595926|NCT02216812|Secondary|Active Flexion Index Through Small Finger|Active flexion will be measured using a handheld goniometer. We calculate total active flexion of the index through small finger by summing flexion at the metacarpo-phalangeal, proximal interphalangeal and distal interphalangeal joints|Day 1 (baseline), 6 weeks|Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.|||Degrees||Standard Deviation|Mean
2595927|NCT02216812|Primary|Distance to Palmar Crease Index Through Small Finger|To establish the distance to palmar crease, we asked patients to make a fist and determine the distance from nail tip to palmar crease for each individual digit using a ruler. We defined total distance to palmar crease as the sum of the values for the index, long, ring, and small fingers.|Day 1 (baseline), 6 weeks|Some subjects were lost to follow up between enrollment, 6 week visit, and 6 month surveys.|||Centimeters||Standard Deviation|Mean
2595928|NCT02216773|Secondary|Number of Participants With Postoperative Complications (Dindo Clavien ≥Grade 3b)|As defined by Dindo Clavien classification of surgical complications (≥grade 3b).|Up to hospital discharge (estimated to be between 2 and 10 days)||||Participants|||Count of Participants
2595929|NCT02216773|Secondary|Postoperative Liver Function Tests|Blood tests|Postoperatively (daily until discharge; then at clinic appointments up to 18 months from randomization)|Data not collected||||||
2595930|NCT02216773|Primary|Changes in Liver Remnant Volume|Percentage change in remnant liver volume following intervention. This will be measured by volumetric analysis of CT scan. Positive number represents increases and negative number represents decreases.|2 or 4 weeks post intervention (2 weeks post RALPP; 4 weeks post PVE)||||percentage change||Standard Deviation|Mean
2595931|NCT02216695|Secondary|Mortality From Acute Kidney Injury in Each Five-year Period From 1998 to 2013|The secondary objective is evaluate factors affecting mortality due to acute kidney injury in the fifteen year period between 1998 and 2013.|Participants will be followed for the duration of hospital stay (average 13 days)||||participants|||Number
2595932|NCT02216695|Secondary|Mortality From Acute Kidney Injury in Each Age Group From 1998 to 2013|The secondary objective is evaluate factors affecting mortality due to acute kidney injury in the fifteen year period between 1998 and 2013.|Participants will be followed for the duration of hospital stay (average 13 days)||||participants|||Number
2595933|NCT02216695|Primary|Incidence of AKI-D From 1998-9 to 2012-13|The population incidence of acute kidney injury requiring dialysis (AKI-D) was calculated using mid-year population of England in each year from 1998 to 2013 and expressed as people per million population. This was calculated by dividing number of cases by mid year population of England and multiplying by million.|15-years||||cases per million population|||Number
2595934|NCT02216695|Primary|Secular Trends in the Mortality After Acute Kidney Injury From 1998 to 2013|A retrospective cohort study of patients with acute kidney injury in England over a period of fifteen years, describing the trends in the mortality of acute kidney injury.|Participants will be followed for the duration of hospital stay (average of 15 days)||||participants|||Number
2595935|NCT02216591|Other Pre-specified|Change in Mean Percent Adherence Across All Antiretroviral Medications||Baseline and 10 weeks||||Percent of doses||Standard Deviation|Mean
2595936|NCT02216591|Secondary|Change in Delay Discounting|"Measured by Monetary-Choice Questionnaire (MCQ), a standardized task that measures delay discounting. Participants are presented with choices between smaller, immediate rewards and larger, delayed rewards (e.g., Would you prefer $54 today or $80 in 30 days?). Participants' hyperbolic discount parameter (k value) is determined by fitting data to the following discount function equation: Vimmediate = Vdelayed / (1 + kD), in which V is the reward value in dollars and D is delay in days. K-values on this scale can range from 0.00016 to 4.00 and to normalize scores, these values were ranked from 1 to 13 for analyses. A higher rank indicates greater delay discounting."|Baseline and 10 weeks||||Mean K value rank for MCQ||Standard Deviation|Mean
2595937|NCT02216591|Primary|Change in Working Memory|Standardized neuropsychological tests of working memory used in this study were the Paced Auditory Serial Addition Task-50 and Neuropsychological Assessment Battery Digits Forward/Digits Backward Test. Using the most up-to-date published normative data, raw test scores were converted to T-scores that corrected for demographic factors such as age and education. T scores can range from 0 to 100, with 50 being average and higher scores indicating better function. The overall working memory score was computed by averaging T-scores of each of the individual tests. To examine intervention effects on working memory outcomes, we conducted a 2 (Arm: ACT vs. CON) × 2 (Time: Baseline vs. Post) mixed-model general linear model analyses. Time was the within-subjects factor defined by baseline versus 10 week follow-up, and study arm was the between-subjects factor. Age and years of education were included as covariates. The means reported here are the mean scores at 10 weeks.|Baseline and 10 weeks||||mean T score on working memory tests||Standard Error|Mean
2595938|NCT02216526|Secondary|Itch Assessment. Question 5. Affecting of Daily Activities ( 1 = Never Affects Activity; 2 = Rarely Affects Activity; 3 = Occasionally Affects Activity; 4 = Frequently Affects Activity; 5 = Always Affects Activity) at Day 56 +/-3|"Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'."|Day 56 +/-3|Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question. In the Cetaphil Group one value is missing for that question.|||units on a scale||Standard Deviation|Mean
2595939|NCT02216526|Secondary|Itch Assessment. Question 4. Affecting of Sleep (See Score Details in the Outcome Measure Description) at Day 56 +/-3|"Self-completion of the 5-D itch scale. Question 4: 1=Never affects sleep;2=Occasionally delays falling asleep;3=Frequently delays falling asleep;4=Delays falling asleep and occasionally wakes me up;5=Delays falling asleep and frequently wakes me up at night.~Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'."|Day 56 +/-3|Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question.|||units on a scale||Standard Deviation|Mean
2595940|NCT02216526|Secondary|Itch Assessment. Question 3. Changes in Intensity of Itch (Past Two Weeks). (1 = Completely Resolved; 2 = Much Better But Still Present; 3 = Little Bit Better, But Still Present; 4 = Unchanged, 5 = Getting Worse) at Day 56 +/-3|"Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'."|Day 56 +/-3|Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question.|||units on a scale||Standard Deviation|Mean
2595941|NCT02216526|Secondary|Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Day 56 +/-3|"Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'."|Day 56 +/-3|Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question.|||units on a scale||Standard Deviation|Mean
2595942|NCT02216526|Secondary|Itch Assessment. Question 1. Hours of Itching (1 = Less Than 6hours/Day; 2 = 6-12 Hours/Day; 3 = 12-18 Hours/Day; 4 = 18-23hours/Day; 5 = All Day) at Day 56 +/-3|"Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'."|Day 56 +/-3|Only participants not being cognitively impaired were able to answer the questionnaires. Due to a number of loss to follow up at the end of the study, n = 28/117 answer these question. In the Excipial Group one value is missing for that question.|||units on a scale||Standard Deviation|Mean
2595951|NCT02216526|Secondary|Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Day 56 +/-3|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Day 56 +/-3|Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.|||units on a scale||Standard Deviation|Mean
2595943|NCT02216526|Secondary|Itch Assessment. Question 5. Affecting of Daily Activities ( 1 = Never Affects Activity; 2 = Rarely Affects Activity; 3 = Occasionally Affects Activity; 4 = Frequently Affects Activity; 5 = Always Affects Activity) at Baseline|"Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'."|Baseline|Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline). One value in the Cetaphil Group is missing for this question.|||units on a scale||Standard Deviation|Mean
2595944|NCT02216526|Secondary|Itch Assessment. Question 4. Affecting of Sleep (See Score Informations in the Outcome Measure Description) at Baseline|"Self-completion of the 5-D itch scale. Question 4: 1=Never affects sleep;2=Occasionally delays falling asleep;3=Frequently delays falling asleep;4=Delays falling asleep and occasionally wakes me up;5=Delays falling asleep and frequently wakes me up at night.~Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'."|Baseline|Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).|||units on a scale||Standard Deviation|Mean
2595945|NCT02216526|Secondary|Itch Assessment. Question 3. Changes in Intensity of Itch (Past Two Weeks). (1 = Completely Resolved; 2 = Much Better But Still Present; 3 = Little Bit Better, But Still Present; 4 = Unchanged, 5 = Getting Worse) at Baseline|"Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'."|Baseline|Only participants not being cognitively impaired were able to answer the quastionnaires (in total n = 32/133 at baseline). One value in the Excipial Group is missing for this question.|||units on a scale||Standard Deviation|Mean
2595946|NCT02216526|Secondary|Itch Assessment. Question 2. Itch Intensity (1 = Not Present; 2 = Mild; 3 = Moderate; 4 = Severe; 5 = Unbearable) at Baseline|"Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'."|Baseline|Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).|||units on a scale||Standard Deviation|Mean
2595947|NCT02216526|Secondary|Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Day 56 +/-3|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Day 56 +/-3|Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.|||units on a scale||Standard Deviation|Mean
2595948|NCT02216526|Secondary|Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Day 56 +/-3|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Day 56 +/-3|Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.|||units on a scale||Standard Deviation|Mean
2595949|NCT02216526|Secondary|Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Day 56 +/-3|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Day 56 +/-3|Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.|||units on a scale||Standard Deviation|Mean
2595950|NCT02216526|Secondary|Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Day 56 +/-3|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Day 56 +/-3|Only residents not being cognitively impaired were able to answer the questionnaires. Due to loss to follow up only n = 28/117 participants were able to answer at the end of the study.|||units on a scale||Standard Deviation|Mean
2595980|NCT02216357|Secondary|Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate (NIFR) Compared to Baseline During the Aspirin Challenge||Study Day 2 and 3||||Participants|||Count of Participants
2595952|NCT02216526|Secondary|Quality of Sleep. Question 5. Bad Sleep (0) - Good Sleep (10) at Baseline|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Baseline|Only residents not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline)|||units on a scale||Standard Deviation|Mean
2595953|NCT02216526|Secondary|Quality of Sleep. Question 4. Not Back to Sleep (0) - Back to Sleep Immediately (10) at Baseline|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Baseline|Only residents being not cognitively impaired were able to answer the questionnaires (in total 32/133 at baseline).|||units on a scale||Standard Deviation|Mean
2595954|NCT02216526|Secondary|Quality of Sleep. Question 3. Awake All Night (0) - Awake Very Little (10) at Baseline|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Baseline|Only residents being not cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).|||units on a scale||Standard Deviation|Mean
2595955|NCT02216526|Secondary|Quality of Sleep. Question 2. Never Fall Asleep (0) - Immediately Fall Asleep (10) at Baseline|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Baseline|Only residents being not cognitively impaired were able to answer the questionnaires (in total n = 32/133).|||units on a scale||Standard Deviation|Mean
2595956|NCT02216526|Secondary|Quality of Life Sum Score at Day 56 +/-3|Self-completion of the WHO-Five Well-being Index. Well-being was assessed with the WHO-Five Well-being Index. The German version of the questionnaire published by the World Health Organization in 1998 was used. Scores range from '5' (all the time) to '0' (never) for in total five items. Simple questions were asked regarding well-being in the last two weeks, e.g. 'In the last two weeks … I was happy' or '…I was relaxed'. The sum scores range from 0, indicating the lowest well-being, to 25, indicating the highest well-being. A cut-off score of < 13 is recommended. The validity and reliability of the questionnaire was recently supported.|Day 56 +/-3|Only residents being cognitively not impaired were able to answer the questionnaires (in total n = 28/117 at the end of the study).|||units on a scale||Standard Deviation|Mean
2595957|NCT02216526|Secondary|Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 56 +/-3|Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification|Day 56 +/-3|In total n = 16 participants were loss to follow up after eight weeks (end of the study).|||Participants|||Count of Participants
2595958|NCT02216526|Secondary|Number of Participants With Incontinence Associated Dermatitis (IAD) at Day 28 +/-3|Clinical assessment of the presence and/or severity of incontinence associated dermatitis according to the IAD-IT classification|Day 28 +/-3|In total n = 13 participants were loss to follow up after 4 weeks.|||Participants|||Count of Participants
2595959|NCT02216526|Secondary|Number of Participants With Skin Tears at Day 56 +/-3|Clinical assessment aof the presence of skin tears according to the STAR Classification|Day 56 +/-3|In total n = 16 participants were loss to follow up after eight weeks (end of the study).|||Participants|||Count of Participants
2595960|NCT02216526|Secondary|Number of Participants With Skin Tears at Day 28 +/-3|Clinical assessment aof the presence of skin tears according to the STAR Classification|Day 28 +/-3|In total n = 13 participants were loss to follow up after 4 weeks.|||Participants|||Count of Participants
2595961|NCT02216526|Secondary|Number of Participants With Skin Tears at Baseline|Clinical assessment of the presence of skin tears according to the STAR Classification|Baseline||||Participants|||Count of Participants
2595962|NCT02216526|Secondary|Number of Participants With Pressure Ulcer at Day 56 +/-3|Clinical assessment of the presence of a pressure ulcer.|Day 56 +/-3|At the end of the study, in total n = 16 participants were loss to follow up.|||Participants|||Count of Participants
2595963|NCT02216526|Secondary|Number of Participants With Pressure Ulcer at Day 28 +/-3|Clinical assessment of the presence of pressure ulcer.|Day 28 +/-3|After 4 weeks of the study, in total n= 13 participants were loss to follow up.|||Participants|||Count of Participants
2595964|NCT02216526|Secondary|Quality of Life Sum Score at Baseline|Self-completion of the WHO-Five Well-being Index. Well-being was assessed with the WHO-Five Well-being Index. The German version of the questionnaire published by the World Health Organization in 1998 was used. Scores range from '5' (all the time) to '0' (never) for in total five items. Simple questions were asked regarding well-being in the last two weeks, e.g. 'In the last two weeks … I was happy' or '…I was relaxed'. The sum scores range from 0, indicating the lowest well-being, to 25, indicating the highest well-being. A cut-off score of < 13 is recommended. The validity and reliability of the questionnaire was recently supported.|Baseline|Only residents being cognitively not impaired were able to answer the questionnaires (At baseline n = 32/133)|||units on a scale||Standard Deviation|Mean
2595965|NCT02216526|Secondary|Quality of Sleep. Question 1. Light Sleep (0) - Deep Sleep (10) at Baseline|Self-completion of the Richards-Campbell Sleep Questionnaire (RCSQ).Sleep quality was assessed with the Pittsburgh Richard Campbell Sleep Quality Assessment. Five questions were asked regarding the sleep quality for the last night via 0-100mm visual analogue scales. The interrater reliability and the most usefulness was recently supported.|Baseline|Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).|||units on a scale||Standard Deviation|Mean
2595966|NCT02216526|Secondary|Number of Participants With Incontinence Associated Dermatitis (IAD) at Baseline|Clinical assessment of the presence of incontinence associated dermatitis according to the IAD-IT classification|Baseline||||Participants|||Count of Participants
2595967|NCT02216526|Secondary|Number of Participants With a Pressure Ulcer at Baseline|Clinical assessment of the presence of a pressure ulcer.|Baseline||||Participants|||Count of Participants
2595968|NCT02216526|Secondary|Itch Assessment. Question 1. Hours of Itching (1 = Less Than 6 Hours/Day; 2 = 6-12 Hours/Day; 3 = 12-18 Hours/Day; 4 = 18-23hours/Day; 5 = All Day) at Baseline|"Self-completion of the 5-D itch scale. Having a 6-CIT score of 7 or lower was the criterion to administer the 5-D itch scale.The score of the 5-D Itch scale ranges from '5' (no pruritus) to '25' (most severe pruritus) and contains five items measuring pruritus over the past two weeks.~A possible cognitive impairment was tested using the Six Item Cognitive Impairment Test on Day 0. It includes six simple questions, for example 'What year is it?' or 'Count backwards from 20 to 10. Scores may range from 0 (= no sign of cognitive impairment) to a maximum score of 28 (= significant cognitive impairment). Residents with sum scores > 8 were classified as 'cognitively impaired'."|Baseline|Only participants not being cognitively impaired were able to answer the questionnaires (in total n = 32/133 at baseline).|||units on a scale||Standard Deviation|Mean
2595969|NCT02216526|Secondary|Skin Surface pH|Changes in Skin surface pH at the lower leg. Skin surface pH was measured with the Skin-pH-Meter PH 905 (Courage + Khazaka, Cologne, Germany), a planar glass electrode. The pH is a measure of acidity and alkalinity of a solution and it indicates the concentration of the hydrogen ions in an aqueous solution. Reference values of human skin have been reported to range from 4 to 6.|Baseline, Day 56 +/- 4|At Day 56 +/- 3 data of six participants to calculate the change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 39/40 participants were analyzed. In Group II (Excipial) 40/41 participants were analyzed. In Group III (Standard Skin care) 32/36 participants were analyzed.|||units on a scale||Standard Deviation|Mean
2595970|NCT02216526|Secondary|Transepidermal Water Loss (TEWL)|Change in Transepidermal water loss (TEWL) at the lower leg. Transepidermal water loss was measured with the Tewameter TM 300 (Courage + Khazaka, Cologne, Germany). The probe captures the constant permeation of water through the stratum corneum in gram per hour per m2. The measuring probe contains a pair of sensors that are located in different distances to the skin surface to determine temperature and relative humidity above the skin surface. The humidity gradient between both sensors is used for calculating the transepidermal water loss. Higher values indicate a higher transepidermal water loss.|Baseline, Day 56 +/- 4|At Day 56 +/- 3 data of twelve participants to calculate the change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 36/40 participants were analyzed. In Group II (Excipial) 38/41 participants were analyzed. In Group III (Standard Skin care) 31/36 participants were analyzed.|||g/m2/h||Standard Deviation|Mean
2595971|NCT02216526|Secondary|Stratum Corneum Hydration (SCH)|Change in Stratum corneum hydration (SCH) at the lower leg. Instrumental skin measurements were conducted to characterize possible effects of the interventions in terms of skin function. The stratum corneum hydration was measured using the Corneometer CM 825 (Courage + Khazaka, Cologne, Germany). This measurement is based on the differences of the dielectric constant of water and other substances. With this device, only the moisture content in the stratum corneum is measured. The arbitrary units (a.u.) range from 0 to 120 where as higher readings indicate higher stratum corneum hydration.Values > 40 a.u. are often considered 'normal', whereas values < 40 a.u. are regarded as typical for dry Skin.|Baseline, Day 56 +/- 4|At Day 56 +/- 3 data of four participants to calculate the change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 39/40 participants were analyzed. In Group II (Excipial) 40/41 participants were analyzed. In Group III (Standard Skin care) 34/36 participants were analyzed.|||arbitrary units||Standard Deviation|Mean
2595972|NCT02216526|Primary|Change From Baseline in Overall Dry Skin Score (ODS)|Clinical assessment of the presence or severity of skin dryness using a five point rating scale at right lower leg. The Overall Dry Skin score is a clinical assessment of the presence and severity of skin dryness using a five-point scale. A score of '0' indicates no skin dryness, whereas a score of '4' indicates advanced skin roughness, large scales, inflammation and cracks.|Baseline; Day 56+/-4|At Day 56 +/- 3 data of two participants to calculate the Change from Baseline to Day 56 +/-3 were missing. In Group I (Cetaphil) 39/40 participants were analyzed. In Group III (Standard Skin care) 35/36 participants were analyzed.|||units on a scale||Standard Deviation|Mean
2595973|NCT02216422|Secondary|Percentage of Participants With Post-Treatment Relapse|Post- Treatment Relapse is defined as confirmed HCV RNA >= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug [up to and including the SVR12 assessment time point] for a participant with HCV RNA < LLOQ at Final Treatment Visit who completes treatment.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants||95% Confidence Interval|Number
2595974|NCT02216422|Secondary|Percentage of Participants With On-Treatment Virologic Failure|On-Treatment Virologic Failure is defined as confirmed HCV RNA >= LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir] at any time point during treatment, or failure to suppress during treatment [all on-treatment values of HCV RNA >= LLOQ] with at least 6 weeks [defined as active study drug duration ≥ 36 days] of treatment.|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants||95% Confidence Interval|Number
2595975|NCT02216422|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants||95% Confidence Interval|Number
2595976|NCT02216357|Secondary|Proportion of Patients With an Aspirin Desensitization Dose Level of 30 mg, 60 mg, 100 mg, 150 mg, and 325 mg.||Study Day 2 and 3||||Participants|||Count of Participants
2595977|NCT02216357|Secondary|Incidence and Severity of Asthmatic Reactions During the Treatment Period||Study Day 1 through 3||||Participants|||Count of Participants
2595978|NCT02216357|Secondary|Amount of Rescue Medication Required During the Aspirin Challenge|The amount of rescue medication required during the aspirin challenge|Study Day 2 and 3||||number of rescue medications||Standard Deviation|Mean
2595979|NCT02216357|Secondary|Proportion of Patients With a ≥ 25% Increase in TNSS Compared to Baseline During the Aspirin Challenge||Study Day 2 and 3||||Participants|||Count of Participants
2595981|NCT02216357|Secondary|Proportion of Patients Who Experience a ≥ 20% Decrease in FEV1 Compared to Baseline During the Aspirin Challenge||Study Day 2 and 3||||Participants|||Count of Participants
2595983|NCT02216357|Secondary|Proportion of Patients With a ≥ 25% Increase in Total Nasal Symptom Score (TNSS) Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge||Up to Study Day 2||||Participants|||Count of Participants
2595984|NCT02216357|Secondary|Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge||Up to Study Day 2||||Participants|||Count of Participants
2595985|NCT02216357|Primary|Proportion of Patients Who Experience a ≥ 20% Decrease in Forced Expiratory Volume in One Second (FEV1) Compared to Baseline Following a Dose of Investigational Medicinal Product (IMP) (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge||Study Day 2||||Participants|||Count of Participants
2595986|NCT02216214|Secondary|Change From Baseline in Post-void Residual Volume (PVR)|PVR was assessed by ultrasonography or bladder scan.|Baseline and EOT (up to 12 weeks)|The analysis population was the SAF. Participants with available data are included in the analysis. LOCF was used for EOT.|||mL||Standard Deviation|Least Squares Mean
2595987|NCT02216214|Secondary|Change From Baseline to EOT in Montreal Cognitive Assessment (MoCA) Score|The MoCA was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points, with lower scores indicating worse cognitive function.|Baseline and EOT (up to 12 weeks)|The analysis population was the SAF. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.|||units on a scale||Standard Error|Least Squares Mean
2595988|NCT02216214|Secondary|Number of Participants With Adverse Events (AEs)|Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. AEs were considered as serious if resulted in in death, was life-threatening resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required inpatient hospitalization or led to prolongation of hospitalization and other medically important events.|From first dose of study drug up to 30 days after last dose of study drug (up to 13 weeks)|The analysis population was the SAF.|||Participants|||Count of Participants
2595989|NCT02216214|Secondary|Percentage of Participants Major (≥ 2-Point) Improvement From Baseline in PPBC|The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. Participants with ≥ 2-point improvement from baseline in PPBC were defined as participants with at least 1-point improvement from baseline in PPBC at each visit.|End of treatment (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. NRI was used for EOT.|||percentage of participants|||Number
2595990|NCT02216214|Secondary|Percentage of Participants With ≥ 1-Point Improvement From Baseline in PPBC|The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition. Participants with ≥ 1-point improvement from baseline in PPBC were defined as participants with at least 1-point improvement from baseline in PPBC at each visit.|End of treatment (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. NRI was used for EOT.|||percentage of participants|||Number
2595991|NCT02216214|Secondary|Percentage of Participants With ≥ 10-Point Improvement From Baseline in OAB-q HRQL Subscales|The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. Participants with ≥ 10-point improvement from baseline in OAB-q HRQL subscales were defined as participants with at least 10-point improvement from baseline in OAB-q Subscales at each visit.|End of treatment (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. NRI was used for EOT.|||percentage of participants|||Number
2595992|NCT02216214|Secondary|Percentage of Participants With Zero Incontinence Episodes Per 24 Hours|An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with zero incontinence episodes per 24 hours were defined as participants who had no incontinence episodes per 24 hours during the treatment period at each visit.|End of treatment (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. NRI was used for EOT.|||percentage of participants|||Number
2595993|NCT02216214|Secondary|Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode was defined as the complaint of any involuntary leakage of urine. Participants with 50% reduction in mean number of incontinence episodes per 24 hours were defined as participants with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at each visit.|End of treatment (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. NRI was used for EOT.|||percentage of participants|||Number
2596191|NCT02213510|Primary|Overall Closure Time|Duration of time starting when suture needle (control) or Zip device touches the skin until final suture knot is cut or Zip device application is complete (e.g., top liner is removed.)|2 weeks||||seconds||Standard Deviation|Mean
2595994|NCT02216214|Secondary|Percentage of Participants Who Achieved Micturition Frequency Normalization|Participants who achieved micturition frequency normalization were defined as participants who had at least 8 micturitions per 24 hours at baseline and less than 8 micturitions per 24 hours post-baseline.|End of treatment (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. Non-responder imputation (NRI) was used for EOT.|||percentage of participants|||Number
2595995|NCT02216214|Secondary|Change From Baseline in Number of Pads During 3-Day Diary Prior to Each Visit|The number of pads were calculated as the number of times a participant records a new pad used during the 3-day micturition diary period. No data were collected for the number of pads used due to a failure in the programming of the diary used for data collection.|Baseline and EOT (up to 12 weeks)|The analysis population was the FAS-I.||||||
2595996|NCT02216214|Secondary|Change From Baseline in Number of Incontinence Episodes Reported During 3-Day Diary Prior to Each Visit|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes were calculated as the total number of the incontinence episodes recorded during the 3-day micturition diary period.|Baseline and Weeks 4, 8 and EOT (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at all time points are included in the analysis. LOCF was used for EOT.|||incontinence episodes||Standard Error|Mean
2595997|NCT02216214|Secondary|Change From Baseline to EOT in University of Alabama, Birmingham - Life Space Assessment (UAB-LSA)|The UAB-LSA measures mobility in terms of the spatial extent of a person's life. Life space is defined based upon the distance a person routinely travels to perform activities over this time frame. The UAB-LSA includes determining how far and how often the person leaves his or her place of residence and the degree of independence the person has. Each level of life space represents a distance further from the room where one sleeps: 0 - Mobility limited to the room where one sleeps; 1 - Mobility limited to within one's dwelling; 2 - Mobility limited to the space just proximal to one's personal living space (for instance, a porch, patio, or yard just outside the home or hallway outside of an apartment); 3 - Mobility limited to one's neighborhood; 4 - Mobility limited to one's town; 5 - Mobility outside one's town. The total scores ranges from 0-120, where a higher score indicates greater mobility.|Baseline and EOT (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.|||units on a scale||Standard Error|Least Squares Mean
2595998|NCT02216214|Secondary|Change From Baseline to EOT in Treatment Satisfaction Visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale that asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) to 100 (Yes, completely).|Baseline and EOT (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.|||units on a scale||Standard Error|Least Squares Mean
2595999|NCT02216214|Secondary|Change From Baseline to EOT in OAB-q HRQL Subscale Scores|The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The Coping score has 8 items, the Concern score has 7 items, the Sleep and Social score has 5 items each. Each subscale score was calculated by adding each score's items and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and EOT (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.|||units on a scale||Standard Error|Least Squares Mean
2596000|NCT02216214|Secondary|Change From Baseline to EOT in PPIUS|The PPIUS is a 5-point categorical scale used by participants to rate the degree of associated urgency for each micturition and/or incontinence episode they experienced. categories include: 0 - No urgency, I felt no need to empty my bladder, but did so for other reasons; 1 - Mild urgency, I could postpone voiding as long as necessary, without fear of wetting myself; 2 - Moderate urgency, I could postpone voiding for a short while, without fear of wetting myself; 3 - Severe urgency, I could not postpone voiding, but had to rush to the toilet in order not to wet myself; 4 - Urge incontinence, I leaked before arriving at the toilet. Scores were recorded in the micturition diary.|Baseline and EOT (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.|||units on a scale||Standard Error|Least Squares Mean
2596001|NCT02216214|Secondary|Change From Baseline to EOT in Vulnerable Elder Survey-13 (VES-13) Score|The VES-13 is a simple function-based tool for screening community-dwelling populations to identify older persons at risk for health deterioration. The VES-13 considers age, self-related health, limitation in physical function, and functional disabilities. The total possible score ranges from 0 to 10, with higher scores indicating increased disability.|Baseline and EOT (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.|||units on a scale||Standard Error|Least Squares Mean
2596002|NCT02216214|Secondary|Change From Baseline to EOT in Barthel Index of Daily Living Score|The Barthel Index consists of 10 items that measure a person's daily functioning; specifically the activities of daily living and mobility. The total possible score ranges from 0 to 20, with lower scores indicating increased disability.|Baseline and EOT (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.|||units on a scale||Standard Error|Least Squares Mean
2596003|NCT02216214|Secondary|Change From to EOT in Mean Number of Nocturia Episodes Per 24 Hours|A nocturia episode was defined as waking at night one or more time to void (i.e., any voiding associated with sleep disturbance between the date/time the participant goes to bed with the intention to sleep until the date/time the participant gets up in the morning with the intention to stay awake). A night time episode of incontinence only is not considered a nocturia episode. The mean number of nocturia episodes per 24 hours was calculated as the average number of times a participant recorded a nocturia episode per day during the 3-day micturition diary period.|Baseline and EOT (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.|||nocturia episodes/24 hours||Standard Error|Least Squares Mean
2596004|NCT02216214|Secondary|Change From Baseline to EOT in Mean Number of Urgency Incontinence Episodes Per 24 Hours|An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency episodes was calculated as the average number of times a participant recorded an urgency incontinence episode per day during the 3-day micturition diary period.|Baseline and EOT (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.|||urgency incontinence episodes/24 hours||Standard Error|Least Squares Mean
2596005|NCT02216214|Secondary|Change From Baseline to EOT in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours|Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode with a severity of grade 3 or 4, assessed by participants based on the PPIUS, where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet. The mean number of urgency episodes (grade 3 and/or 4) per 24 hours was calculated as the average number of times a participant recorded an urgency episode (grade 3 and/or 4) with or without incontinence per day during the 3-day micturition diary period.|Baseline and EOT (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.|||urgency episodes/24 hours||Standard Error|Least Squares Mean
2596006|NCT02216214|Secondary|Change From Baseline to EOT in Patient Perception of Bladder Condition (PPBC)|The PPBC is a validated, global assessment tool using a 6-point Likert scale that asks participants to rate their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems. A higher score indicated a worse perception of bladder condition.|Baseline and EOT (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.|||units on a scale||Standard Error|Least Squares Mean
2596007|NCT02216214|Secondary|Change From Baseline to EOT in OAB-q: Health Related Quality of Life (HRQL) Total Score|The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and EOT (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.|||units on a scale||Standard Error|Least Squares Mean
2596008|NCT02216214|Secondary|Change From Baseline to EOT in Overactive Bladder Questionnaire (OAB-q): Symptom Bother Score|The OAB-q is a self-reported questionnaire with 33 questions relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 questions, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.|Baseline and EOT (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.|||units on a scale||Standard Error|Least Squares Mean
2596009|NCT02216214|Secondary|Change From Baseline to EOT in Mean Volume Voided Per Micturition|The mean volume voided per micturition during 3 days of the 3-day micturition diary period.|Baseline and EOT (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.|||mL||Standard Error|Least Squares Mean
2596010|NCT02216214|Primary|Change From Baseline to EOT in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated as the average number of times a participant recorded an incontinence episode per day during the 3-day micturition diary period.|Baseline and EOT (up to 12 weeks)|The analysis population was the FAS-I. Participants with available data at baseline and EOT are included in the analysis. LOCF was used for EOT.|||incontinence episodes/24 hours||Standard Error|Least Squares Mean
2596011|NCT02216214|Primary|Change From Baseline to End of Treatment (EOT) in Mean Number of Micturitions Per 24 Hours|A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated as the average number of times a participant urinated per day during the 3-day micturition diary period.|Baseline and EOT (up to 12 weeks)|The analysis population was the FAS-I. Particpants with available data at baseline and EOT are included in the analysis. Last observation carried forward (LOCF) was used for EOT.|||micturitions/24 hours||Standard Error|Least Squares Mean
2596012|NCT02216136|Primary|Quality of Life as Measured by the Breast Q|"The Breast Q is a comprehensive and specific quality of life instrument that allows for patient self-assessment prior to and following breast surgery. Comprised of quality of life and satisfaction domains, and generates domain-specific Q-scores (0-100) constructed using Rasch analysis. The higher the score, the more satisfied the participant was.~-Collected preoperatively (no more than 3 months prior to surgery) and postoperatively (approximately 6 months after conclusion of radiotherapy in the Breast Conservation Cohort and >=3 months after the final balancing reconstructive intervention in the Mastectomy and Reconstruction Cohort."|Compare preoperative values with postoperative values (up to 4 years)|-Mastectomy Only cohort was unable to enroll participants due to: participants who chose mastectomy with no reconstruction almost never had an MRI and MRI was a critical inclusion criteria; most of the participants who were approached were older and refused participation; issue with finding and tracking participants who refused reconstruction|||score on a scale||Standard Deviation|Mean
2596013|NCT02216123|Secondary|Volume of Distribution (Vc/F) of TQ|Apparent population central volume of distribution of TQ|Day 2, Day 3, Day 8, Day 15, Day 29, Day 60 and Day 180|Safety Population|||Liters||90% Confidence Interval|Median
2596014|NCT02216123|Secondary|Oral Clearance (CL/F) of TQ|Apparent population oral clearance of TQ|Day 2, Day 3, Day 8, Day 15, Day 29, Day 60 and Day 180|Safety Population|||Liters per hour||90% Confidence Interval|Median
2596015|NCT02216123|Secondary|Number of Participants With Action Taken to Treat a Hemolysis Event|Health outcomes were evaluated based on the actions taken by the participants to treat hemolysis events. The number of participants in Brazil who attended the trial clinic to treat a hemolysis event has been presented. The aim of this outcome measure was to determine the action taken by a participant due to an event of hemolysis, regardless of treatment received in the study. It was not expected there would be major differences in action taken by the participants with hemoglobin decrease between the treatment arms. This was pre-specified in the statistical analysis plan.|Up to Day 180|Safety Population|||Participants|||Number
2596016|NCT02216123|Secondary|Number of Participants With Action Taken to Treat Relapse Episode of P. Vivax Malaria|Health outcomes were evaluated based on the actions taken by the participants to treat relapse episode of P vivax malaria. The number of participants with the type of action taken to treat relapse episode of P vivax malaria has been presented by country. Participants may be represented in more than one category, so the total number of participants may be less than the number quoted. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Day 180|Safety Population|||Participants|||Number
2596017|NCT02216123|Secondary|Number of Participants or Care Givers Who Had Taken Time Off From Normal Occupation Due to a Hemolysis Event|Health outcomes were evaluated based on total time lost by participants or care givers due to a hemolysis event. The number of participants or care givers who took days off from work due to a hemolysis event has been presented based on the normal occupation. The aim of this outcome measure was to determine the time taken off by participants due to an event of hemolysis, regardless of treatment received in the study. It was not expected there would be major differences in time taken off by participants with hemoglobin decrease between the treatment arms. This was pre-specified in the statistical analysis plan.|Up to Day 180|Safety Population|||Participants|||Number
2596018|NCT02216123|Secondary|Number of Participants or Care Givers Who Had Taken Time Off From Normal Occupation Due to Relapse Episode of Malaria|Health outcomes were evaluated based on total time lost by participants or care givers due to an episode of malaria. The number of participants or care givers who had taken off from their normal occupation due to relapse episode of P vivax malaria has been presented by country. Participants may be represented in more than one category, so the total number of participants may be less than the number quoted. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Day 180|Safety Population|||Participants|||Number
2596019|NCT02216123|Secondary|Cost Incurred With Purchase of Medications Associated With Hemolysis Event|"Health outcomes were evaluated based on the cost of medications purchased. The total medication cost associated with hemolysis event has been presented. Medications recorded as Other and medications without costs are excluded from the analysis. The aim of this outcome measure was to determine the cost to a participant due to an event of hemolysis, regardless of treatment received in the study. It was not expected there would be major cost differences with hemoglobin decrease between the treatment arms. This was pre-specified in the statistical analysis plan."|Up to Day 180|Safety Population|||USD||Standard Deviation|Mean
2596020|NCT02216123|Secondary|Cost Incurred With Purchase of Medications Associated With Relapse Episode of P. Vivax Malaria|"Health outcomes were evaluated based on the cost of medications purchased. The total medication cost for paracetamol associated with relapse episode of P vivax malaria has been presented. Medications recorded as Other and medications without costs are excluded from the analysis. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title)."|Up to Day 180|Safety Population|||USD||Standard Deviation|Mean
2596021|NCT02216123|Secondary|Cost Associated With a Hemolysis Event|Health outcomes were evaluated based on cost incurred due to clinically relevant hemolysis. The total cost was evaluated based on the amount spent on treatment, transport, medication and test. The costs associated with hemolysis event has been presented. The aim of this outcome measure was to determine the cost to a participant due to an event of hemolysis, regardless of treatment received in the study. It was not expected there would be major cost differences with hemoglobin decrease between the treatment arms. This was pre-specified in the statistical analysis plan.|Up to Day 180|Safety Population|||USD||Standard Deviation|Mean
2596022|NCT02216123|Secondary|Cost Associated With Relapse Episode of P Vivax Malaria|Health outcomes were evaluated based on the total costs spent on treatment, transport, medication and tests. The cost was summarized according to the place at which the participant went to for care (drug shop, trial clinic, other clinic, hospital emergency center, other). The costs associated with a relapse episode of P. vivax malaria has been presented. Participants may be represented in more than one category, so the total number of participants may be less than the number quoted. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Day 180|Safety Population. Only those participants who experienced a relapse or who had a follow-up visit for a relapse were included in the analysis.|||US Dollars (USD)||Standard Deviation|Mean
2596023|NCT02216123|Secondary|Change From Baseline in Percent Methemoglobin|Methemoglbin is an oxidized and inactive form of hemoglobin. Methemoglobin assessment was made with the aid of a non-invasive signal extraction pulse CO-Oximeter handheld machine. The change from Baseline in percent methemoglobin by treatment, time and sex has been summarized. The latest pre-treatment assessment where treatment is their first dose of study medication (CQ/PQ/TQ/Placebo) was considered as Baseline value. Change from Baseline is the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Day 120|Safety Population|||Percent change||Standard Deviation|Mean
2596024|NCT02216123|Secondary|Number of Participants With Retinal Changes From Baseline|Ophthalmic assessments were carried out at pre-qualified sites prior to randomization and at Days 29 and 90 and at withdrawal follow-up. Assessments were carried out at Day 180 (and up to resolution) if the Day 90 assessments showed abnormalities. The last assessment performed on the day of randomization or earlier was considered Baseline. Change from Baseline was calculated as the value at post dose visit minus the Baseline value. The number of participants with definite retinal change and questionable (ques) retinal change from Baseline has been presented. The number of participants with maximum change post-Baseline (definite when absent or questionable at Baseline) has been presented for either eye. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Day 180|Ophthalmic Safety Population|||Participants|||Number
2596025|NCT02216123|Secondary|Number of Participants With Change in Best Corrected Visual Acuity Test Scores|Ophthalmic assessments were carried out at pre-qualified sites prior to randomization and at Days 29 and 90 and at withdrawal. Assessments were carried out at Day 180 if the Day 90 assessments showed abnormalities. The last assessment performed on the day of randomization or earlier was considered Baseline. Change from Baseline is the value at post dose visit minus the Baseline value. Best corrected visual acuity was assessed individually for each eye. Scores were recorded as a ratio. The values were used to derive a logMAR score for statistical analysis where logMAR=-1x log10 (ratio score). The number of participants with change in Best Corrected Visual Acuity Test Scores from Baseline has been presented where possible change is defined as a change from Baseline >=0.12 to <0.3 and definite change is defined as a change from Baseline >=0.3 logMAR score. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Day 180|Ophthalmic Safety Population|||Participants|||Number
2596026|NCT02216123|Secondary|Number of Participants With Keratopathy|Ophthalmic assessments were carried out at pre-qualified sites prior to randomization and at Days 29 and 90 and at withdrawal follow-up visit. Assessments were carried out at Day 180 (and up to resolution) if the Day 90 assessments showed abnormalities. The last assessment performed on the day of randomization or earlier was considered Baseline. The number of participants displaying keratopathy in each eye has been summarized for each visit. The number of participants with new keratopathy at any time post Baseline is also reported. Ophthalmic Safety Population comprised of all participants in the Safety Population who have results from any eye assessments. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Day 180|Ophthalmic Safety Population|||Participants|||Number
2596027|NCT02216123|Secondary|Number of Participants With P. Falciparum|Microscopic blood slides (two thick film and one thin film slide) were prepared and examined for asexual parasite count. The number of participants with positive P. falciparum asexual parasite count post Baseline has been summarized for each treatment arm.|Up to Day 180|mITT Population|||Participants|||Number
2596028|NCT02216123|Secondary|Change From Baseline in Temperature|Vital signs were performed twice a day on Days 1 through 3, at least 4 hours apart, and immediately prior to PK measurements. The mean and standard deviation of pulse rate has been presented. The values presented does not include Day 3 assessments for participant number 570. Baseline value is defined as the latest pre-treatment assessment where treatment is their first dose of study medication (CQ/PQ/TQ/Placebo). Change from Baseline is the value at post dose minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Day 180|Safety Population|||Celsius||Standard Deviation|Mean
2596029|NCT02216123|Secondary|Change From Baseline in Pulse Rate|Vital signs were measured twice a day on Days 1 through 3, at least 4 hours apart, and immediately prior to PK measurements. The mean and standard deviation of pulse rate has been presented. The values presented does not include Day 3 assessments for participant number 570. Baseline value is defined as the latest pre-treatment assessment where treatment is their first dose of study medication (CQ/PQ/TQ/Placebo). Change from Baseline is the value at post dose minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Day 180|Safety Population|||beats per minute||Standard Deviation|Mean
2596030|NCT02216123|Secondary|Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP)|Vital signs were measured twice a day on Days 1 through 3, at least 4 hours apart, and immediately prior to pharmacokinetic (PK) measurements. MAP was calculated as the sum of SBP and two times DBP divided by 3. The mean and standard deviation of SBP, DBP and MAP has been presented. The values presented does not include Day 3 assessments for participant number 570. Baseline value is defined as the latest pre-treatment assessment where treatment is their first dose of study medication (CQ/PQ/TQ/Placebo). Change from Baseline is the value at post dose minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline and up to Day 180|Safety Population|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2596031|NCT02216123|Secondary|Number of Participants With Electrocardiogram (ECG) Findings|12 lead ECG was performed with the participant in a semi-supine position having rested in this position for at least 10 minutes. ECG assessments were performed in triplicate at screening followed by single ECGs 12 hours after the first dose of study medication and at Day 29. The number of participants with abnormal-clinically significant ECG findings have been presented. The 12 Hour Post Randomized Treatment (11.5-12.5 Hours) timepoint included all readings taken between 11.5 and 12.5 hours post randomized treatment. The 12 Hour Post Randomized Treatment (8-72 Hours) timepoint is a sensitivity analysis of the 12 Hour post randomized treatment timepoint, including all readings taken between 8 and 72 hours post randomized treatment. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Up to Day 29|Safety Population|||Participants|||Number
2596032|NCT02216123|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) is defined as any untoward medical occurrence in a participant under clinical investigation, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/ birth defect, other situations such as important medical events and events of possible drug induced liver injury with hyperbilirubinemia. TEAEs are defined as AEs with an onset date and time on or after that of the start of first dose of study medication (including CQ). Number of participants with TEAEs and serious TEAEs have been presented.|Up to Day 180|Safety Population|||Participants|||Number
2596033|NCT02216123|Secondary|Number of Participants With Abnormal Urinalysis Dipstick Results|Mid-stream urine was collected and analyzed for bilirubin, glucose, ketones, leukocyte esterase (LE), nitrites, occult blood, proteins and urobilinogen by dipstick method. The number of participants with abnormal urinalysis results (Trace, +, ++, +++, ++++) has been presented. Only those participants with data available at the specified data points were analyzed.|Up to Day 120|Safety Population|||Participants|||Number
2597521|NCT02196714|Primary|Vd/F|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrroniuml by Treatment|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||L||Full Range|Mean
2596034|NCT02216123|Secondary|Number of Participants With Hematology Laboratory Data Outside the Reference Range|Blood samples were collected for the evaluation of hematology parameters including eosinophils, leukocytes, lymphocytes, neutrophils, platelets, reticulocytes and methemoglobin. The number of participants with hematology laboratory data outside the extended normal range (F3) has been presented. The upper and lower limits for F3 range were defined by multiplying the normal range limits by different factors. High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment. Participants having both High and Low values for Normal Ranges at any post-baseline visits for safety parameters were counted in both the High and Low categories.|Up to Day 120|Safety Population|||Participants|||Number
2596035|NCT02216123|Secondary|Number of Participants With Clinical Chemistry Laboratory Data Outside the Reference Range|Plasma or serum samples were anlalyzed to evaluate clinical chemistry parameters such as alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin, creatine kinase, creatinine, glomerular filtration rate (GFR), indirect bilirubin and urea. The number of participants with clinical chemistry laboratory values outside the extended normal range (F3) has been presented. The upper and lower limits for F3 range were defined by multiplying the normal range limits by different factors. High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment. Safety Population consisted of all randomized participants who received at least one dose of blinded study medication.|Up to Day 120|Safety Population|||Participants|||Number
2596036|NCT02216123|Secondary|Number of Participants With Genetically Homologous and Genetically Heterologous P. Vivax Infections|Two drops of peripheral blood were collected onto pre-printed filter paper for subsequent deoxyribonucleic acid (DNA) extraction and polymerase chain reaction (PCR) analysis of Plasmodium species on all participants at screening (Day 1; pre-dose) and; if necessary, at the time of the first recrudescence/relapse or re-infection. PCR of the P. vivax genes, was used to distinguish between genetically homologous and genetically heterologous infection. The number of participants with genetically homologous and genetically heterologous P. vivax infections has been summarized for each treatment group. Only those participants with an infection occuring on or after Study Day 33 were analyzed.|Up to Day 180|mITT Population. Only those participants who had a recurrence of infection were included in the analysis.|||Participants|||Number
2596037|NCT02216123|Secondary|Number of Participants With Recrudescence|Recrudescence is defined as any P. vivax parasitemia occurring on or before Day 32 (that is, blood stage treatment failure). A participant was considered to have had a recrudescence if both of the following were true: a) Participant had a positive P. vivax asexual parasite count at Baseline and demonstrated clearance (that is, did not have two negative asexual P. vivax parasite counts, with at least 6 hours between the counts, and no positive counts in the interval). b) Participant had a positive genetically homologous asexual P. vivax parasite count, after their zero count in Days 1 to 5, but on or before Study Day 32. The number of participants with recrudescence before Study Day 33 has been presented.|Up to Day 32|mITT Population|||Participants|||Number
2596038|NCT02216123|Secondary|Time to Gametocyte Clearance|Gametocyte clearance time is defined as time from first dose until the first slide that was gametocyte negative and remained so at the next slide reading. The time taken to achieve gametocyte clearance was analyzed by Kaplan-Meier method.|Up to Day 180|mITT Population|||Hours||95% Confidence Interval|Median
2596039|NCT02216123|Secondary|Time to Fever Clearance|Fever clearance time is defined as the time from first dose of treatment to the time when body temperature falls to normal within Study Days 1-4 and remains normal for at least 48 hours up to the Day 8 visit. Fever clearance was considered to have been achieved once an initial temperature of more than 37.4 degree Celsius is reduced to a value less than or equal to 37.4 degree Celsius, in the absence of value more than 37.4 degree Celsius in the following 48 hours up to the Day 8 visit. The time taken to achieve fever clearance was analyzed by Kaplan-Meier method.|Up to Day 9|mITT Population|||Hours||95% Confidence Interval|Median
2596040|NCT02216123|Secondary|Time to Parasite Clearance|Parasite clearance time is defined as time needed to clear asexual parasite from the blood that is, parasite numbers falling below the limit of detection in the thick blood smear and remaining undetectable after 6 to 12 hours later. The time to achieve parasite clearance was analyzed by Kaplan-Meier methodology. The median parasite clearance time along with 95% confidence interval has been presented for each treatment group.|Up to Day 180|mITT Population|||Hours||95% Confidence Interval|Median
2596041|NCT02216123|Secondary|Time to Relapse of P. Vivax Malaria|Relapse is defined by a positive blood smear with or without vivax symptoms. Relapse is described as any recurrence of malaria that occurred after Day 32 of the study. The time to relapse was analyzed by the Kaplan-Meier method. The median number of days to relapse along with 95% confidence interval has been presented for each treatment group.|Up to Day 180|mITT Population|||Days||95% Confidence Interval|Median
2596042|NCT02216123|Secondary|Rate of Relapse-free Efficacy at Four Months Post Dose|A participant was considered to have demonstrated recurrence-free efficacy at 4 months if: a) Participant had non-zero P. vivax asexual parasite count at Baseline. b) Participant showed initial clearance of P. vivax parasitemia. c) Participant had no positive asexual P. vivax parasite count at any assessment prior to or on Study Day 130 following initial parasite clearance. d) Participant did not take a concomitant medication with anti-malarial activity at any point between Study Day 1 and their last parasite assessment after Study Day 109 (up to and including Study Day 130). e) Participant is parasite-free at 4 months. The rate of relapse-free efficacy was estimated by Kaplan-Meier methodology. The percentage of participants who were relapse-free at 4 months post dose has been presented along with 95% confidence interval.|4 months post dose|mITT Population|||Percentage of participants||95% Confidence Interval|Number
2596053|NCT02216097|Secondary|Change From Baseline in BOLD fMRI Percent Activation in Bilateral Ventromedial Pre-Frontal Cortex (vmPFC)|Difference measured in BOLD fMRI percent activation in the bilateral vmPFC during the fear extinction recall phase of the fear extinction paradigm.|Baseline, Day 2|There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.||||||
2596232|NCT02212977|Primary|Number of Participants With Complication of Wound Dehiscence|To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.|3 months||||participants|||Number
2596043|NCT02216123|Secondary|Rate of Relapse-free Efficacy at Six Months Post Dose|A participant was considered to have demonstrated relapse-free efficacy at 6 months if: a) Participant had non-zero P. vivax asexual parasite count at Baseline. b) Participant showed initial clearance of P. vivax parasitemia defined as two negative asexual P. vivax parasite counts, with at least 6 hours between the counts, and no positive counts in the interval. c) Participant had no positive asexual P. vivax parasite count at any assessment prior to or on Study Day 201 following initial parasite clearance. d) Participant did not take a concomitant medication with anti-malarial activity at any point between Study Day 1 and their last parasite assessment. e) Participant is parasite-free at 6 months. The rate of relapse-free efficacy was estimated by Kaplan-Meier methodology. The percentage of participants who were relapse-free at 6 months post dose has been presented along with 95% confidence interval.|6 months post dose|Microbiologic-Intent-To-Treat (mITT) Population comprised of all randomized participants who received at least one dose of blinded study medication and had microscopically-confimed P. vivax parasitemia at Baseline.|||Percentage of participants||95% Confidence Interval|Number
2596044|NCT02216123|Primary|Percentage of Female Participants With Moderate Glucose-6 Phosphate Dehydrogenase (G6PD) Deficiency Experiencing Clinically Relevant Hemolysis.|Clinically relevant hemolysis is defined as a decrease in hemoglobin of >=30% or >3 g/dL from Baseline; or, an overall drop in hemoglobin below 6.0 g/dL at any visit after the first dose of study medication. Despite additional efforts, no females with moderate G6PD-deficiency were enrolled that experienced clinically-significant hemolysis during the study; hence, the end point could not be estimated.|Up to Day 180|Safety Population||||||
2596045|NCT02216123|Primary|Percentage of Participants With Clinically Relevant Hemolysis.|Clinically relevant hemolysis is defined as a decrease in hemoglobin of >=30% or >3 grams per deciliter (g/dL) from Baseline; or, an overall drop in hemoglobin below 6.0 g/dL at any visit after the first dose of study medication. The percentage of participants with clinically relevant hemolysis has been summarized. Safety Population comprised of all randomized participants who received at least one dose of blinded study medication.|Up to Day 180|Safety Population|||Percentage of participants||95% Confidence Interval|Number
2596046|NCT02216097|Secondary|Number of Participants With Post-Baseline Electrocardiogram (ECG) Values Meeting Criteria of Potential Clinical Concern|ECG criteria of potential clinical concern were QTc absolute value >=450 milliseconds (msec) or QTc absolute change >=30 msec.|Baseline up to Day 18|The safety analysis population included all participants who received study medication.|||participants|||Number
2596047|NCT02216097|Secondary|Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of >=30 millimeters of mercury (mmHg) change from baseline or SBP <90 mmHg; diastolic blood pressure (DBP) >=20 mmHg change from baseline or DBP <50 mmHg.|Baseline up to Day 18|The safety analysis population included all participants who received study medication.|||participants|||Number
2596048|NCT02216097|Secondary|Number of Participants With Clinical Laboratory Values Meeting Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes; liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); chemistry (glucose); urinalysis (dipstick) (urine pH, urine glucose, urine protein, urine blood, urine ketones, urine bilirubin, urine nitrite, urine leukocyte esterase); urinalysis microscopy (urine red blood cell, urine white blood cell, urine bacteria). Only parameters with abnormal values were reported.|Baseline up to Day 18|The safety analysis population included all participants who received study medication.|||participants|||Number
2596049|NCT02216097|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last study drug administration that were absent before treatment or that worsened relative to pretreatment state. AEs included non-serious AEs and SAEs.|Baseline up to 28 days after last study drug administration (Day 35)|The safety analysis population included all participants who received study medication.|||participants|||Number
2596050|NCT02216097|Secondary|Number of Participants With Abnormal Physical Examination Findings|The full physical examination included head, ears, eyes, nose, mouth, skin, heart, and lung examinations, lymph nodes, gastrointestinal, skeletal, and neurological systems.|Baseline to up to Day 18|The safety analysis population included all participants who received study medication.|||participants|||Number
2596051|NCT02216097|Secondary|Change From Baseline in BOLD fMRI Percent Signal Change in Fearful Versus Neutral Face Contrast in Left Amygdala|Difference measured in BOLD fMRI percent signal change in the left amygdala in fearful versus neutral faces during face processing task.|Baseline, Day 8|There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.||||||
2596052|NCT02216097|Secondary|Change From Baseline in BOLD fMRI Percent Signal Change in Fearful Versus Neutral Face Contrast in Right Amygdala|Difference measured in BOLD fMRI percent signal change in the right amygdala in fear versus neutral faces during the emotional face processing task.|Baseline, Day 8|There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to GCP non-compliance that resulted in data integrity and quality issues.||||||
2596230|NCT02212977|Secondary|Healing-incision Cosmesis Score by Visual Analogue Scale|To compare resultant cosmesis with topic skin adhesive closure versus suture closure. Scale is 1-10 with 1 as the best possible outcome and 10 is the worst possible outcome.|3 months|Only participants who completed the Healing-incision cosmesis score by Visual Analogue Scale were included in the analysis.|||units on a scale||Standard Deviation|Mean
2596054|NCT02216097|Primary|Change From Baseline Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging fMRI) Percent Signal Change in Fearful Versus Neutral Face Contrast in Bilateral Amygdala|Baseline BOLD fMRI percent signal change measured from baseline in fearful versus neutral face contrast during the emotional face processing task in bilateral amygdala.|Baseline, Day 8|There were no efficacy evaluations done in this study because of a change in the planned analysis after the study was prematurely terminated due to Good Clinical Practice (GCP) non-compliance that resulted in data integrity and quality issues.||||||
2596055|NCT02215967|Secondary|Number of Participants With Best Response|Best response was assessed by the International Myeloma Working Group response criteria. Partial Remission (PR) is 50% or greater reduction of serum M-protein and 90% or greater reduction in 24-h urinary M-protein. Progressive Disease (PD) is increases of greater or equal to 25% from the lowest post-treatment (nadir) value in serum M-component or urine component or percentage of bone marrow plasma cells. Definite development of new bone lesions or new plasmacytoma. Very Good Partial Remission (VGPR) is serum and urine M-protein detectable by immunofixation but not on electrophoresis. Stringent Complete Remission (sCR) is normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry. Complete Remission is negative immunofixation on the serum and urine. Stable Disease (SD) is not meeting criteria for CR, VGPR, PR or PD.|From start of treatment up to 84 weeks|One participant in Group 9x10(6) did not get CAR T-cells and was deemed ineligible, and 3 participants in Group 9x10(6) were found to be ineligible for treatment.|||Participants|||Count of Participants
2596056|NCT02215967|Primary|Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approx. 3 mos and 7 days for DL 0.3 x 10^6 CAR + T cells, 4 mos and 4 days for 1.0 x 10^6 CAR + T cells, 9 mos and 13 days for 3.0 x 10^6 CAR + T cells, and 48 mos and 12 days for 9.0 x 10^6 CAR + T cells.|One participant in Group 9x10(6) did not get CAR T-cells and was deemed ineligible, and 3 participants in Group 9x10(6) were found to be ineligible for treatment.|||Participants|||Count of Participants
2596057|NCT02215967|Primary|Number of Participants With Dose Limiting Toxicities|Dose limiting toxicities are defined as follows: Grade 3 toxicities possibly or probably related to either the anti-BCMA CAR T cells or the fludarabine and cyclophosphamide chemotherapy and lasting more than 7 days. Grade 4 toxicities possibly or probably related to the study interventions.|After the start of treatment and up to 60 days|One participant in Group 9x10(6) did not get CAR T-cells and was deemed ineligible, and 3 participants in Group 9x10(6) were found to be ineligible for treatment.|||Participants|||Count of Participants
2596058|NCT02215954|Secondary|Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire|"The frequency of the response for yes/no questions was summarized in each of question for each treatment arm.~Whether or not a subject will request for the assigned IMPs again when the next colonoscopy is needed, with yes-or-no answer~Whether or not a subject will refuse the assigned IMPs when it is prescribed for the next colonoscopy, with yes-or-no answer"|Day 0 - Day 1|Intention-To-Treat Analysis set|||percentage of participants||95% Confidence Interval|Number
2596059|NCT02215954|Secondary|Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire|"The mean score of subjects who gave favourable impression on their assigned IMPs with 3 or 5 points scales, and the frequency of the response for yes/no questions was summarized in each of question for each treatment arm.~Ease of consuming the assigned IMPs with a scale of 1(Very easy) to 5 (Very difficult)~Overall impression of the assigned IMPs with a scale of 1(Excellent) to 5 (Bad)~Taste of the assigned IMPs with a scale of 1 (Excellent) to 5 (Bad)~Volume of the assigned IMPs with a scale of 1(Very much) to 3 (No problem)~Impression of the assigned IMPs compared with other colon cleansing products with a scale of 1 (Much better) to 5 (Much worse)"|Day 0 - Day 1|Intention-To-Treat Analysis set|||units on a scale||95% Confidence Interval|Mean
2596060|NCT02215954|Secondary|The Total Scores of the Colon Cleansing Effect by the Investigators at Sites Using the Ottawa Scale|The total Ottawa scale score was calculated by adding the ratings (0 to 4) for each of the three colon segments, Ascending colon (ascending, cecum), Mid colon (transverse, descending), and Recto-sigmoid colon, in addition to the overall fluid quantity rating (0 (small), 1 (medium), or 2 (large) ). This gave a sum of 0 (best) to 12 (worst) for overall assessment of colon cleansing, and an additional 0 to 2 for the global fluid quantity rating. The final range of the score was from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).|Day 1 (day of colonoscopy)|Intention-To-Treat Analysis set|||units on a scale||95% Confidence Interval|Mean
2596061|NCT02215954|Secondary|The Efficacy Rate Based on the Overall Colon Cleansing Effect Assessed by the Investigators at the Sites Using the Japanese Colon Cleansing Scale|The efficacy rate was based on the overall colon cleansing effect as assessed by the investigators at sites: the rate of responders who were defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale, which has scale of 1 (Excellent observation) to 5 (Unable to judge). One of the 5 ratings to each of the colon segments (rectum, sigmoid colon, descending colon, transverse colon, and ascending colon/cecum) was given according to the description and the representative pictures of each rating. A subject who had a 1 or 2 rating in each colon segment was counted as a responder in the overall colon cleansing effect. Otherwise they were counted as a non-responder.|Day 1 (day of colonoscopy)|Intention-To-Treat Analysis set|||percentage of participants|||Number
2596074|NCT02215252|Secondary|Daily Sleep Interference Scale Score (DSIS).|Participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. This score was measured as a weekly average.|Baseline, Week 1, Week 2, Week 3 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||number on a scale||Standard Deviation|Mean
2596062|NCT02215954|Primary|The Efficacy Rate Based on the Overall Colon Cleansing Effect as Assessed by the Independent Central Judging Committee Using the Japanese Colon Cleansing Scale|The efficacy rate was based on the overall colon cleansing effect as assessed by the independent central judging committee: the rate of responders who were defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale, which has scale of 1 (Excellent observation) to 5 (Unable to judge). One of the 5 ratings to each of the colon segments (rectum, sigmoid colon, descending colon, transverse colon, and ascending colon/cecum) was given according to the description and the representative pictures of each rating. A subject who had a 1 or 2 rating in each colon segment was counted as a responder in the overall colon cleansing effect. Otherwise they were counted as a non-responder.|Day 1 (day of colonoscopy)|Intention-To-Treat Analysis set|||percentage of participants|||Number
2596063|NCT02215616|Secondary|Percent Change From Baseline in Caudate Volume (Brain Atrophy) at Week 52|Brain atrophy was assessed using magnetic resonance imaging (MRI) measures of caudate volume. Caudate volume atrophy is a sensitive biomarker in very early HD and correlates with disease progression. Brain atrophy in the caudate refers to the shrinkage in volume, so that a decrease in volume is a positive value, while an increase in volume is a negative value. Percent change in caudate volume at Week 52 was calculated as the change in caudate volume since the baseline visit, divided by the baseline caudate volume and multiplied by 100.|Baseline, Week 52|FAS included all participants in the ITT population (all randomized participants) who received at least 1 dose of study drug and had at least 1 post-baseline TMS assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||percent change||Standard Deviation|Mean
2596064|NCT02215616|Primary|Change From Baseline in UHDRS-TMS at Week 52|UHDRS is a research tool developed by Huntington Disease (HD) Study Group to provide a uniform assessment of the clinical features and course of HD. Components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Motor function assessment includes TMS and Total Functional Capacity (TFC) score. The UHDRS TMS assesses all the motor features of HD and includes maximal chorea, maximal dystonia, ocular pursuit, saccade initiation and velocity, dysarthria, tongue protrusion, finger tapping, hand pronation and supination, luria, rigidity, bradykinesia, gait, tandem walking, and retropulsion pull test. Each of these was rated on a scale of 0 (normal motor function) to 4 (severely impaired motor function). TMS score is a sum of individual scores ranging from 0 (normal motor function) to 124 (severely impaired motor function). Lower TMS scores indicate better motor function.|Baseline, Week 52|Full analysis set (FAS) included all participants in the ITT population (all randomized participants) who received at least 1 dose of study drug and had at least 1 post-baseline TMS assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2596065|NCT02215369|Secondary|Technical Success|Technical Success, defined as successful access and entry into the IPV to be ablated and the ability to deliver the intended laser energy, will be evaluated as a secondary endpoint for inclusion in device labeling.|Treatment|Intent to Treat (ITT) Population|||Veins|Veins||Count of Units
2596066|NCT02215369|Primary|Acute Primary Ablation Success|"The primary effectiveness endpoint is Acute Primary Ablation Success defined as complete lack of flow or IPV disappearance in the entire treated segment. Success will be measured via Duplex Ultrasound imaging performed 10 days (± 3 days) post procedure. Primary ablation success must be measured by a physician other than the physician that performed the study procedure."|10 day|Intent to Treat (ITT) Population|||Veins|Veins||Count of Units
2596067|NCT02215252|Secondary|Plasma Concentration of PF-05089771|All participants in this group were analysed. Only plasma PK concentration of PF-05089771 was analysed.|Baseline, Week 2 and Week 4|The PK concentration analysis set included all randomized participants who received at least one dose of study medication and who had at least 1 measurable concentration.|||ng/ml||Standard Deviation|Mean
2596068|NCT02215252|Secondary|Fasted Low Density Lipoprotein (LDL) Cholesterol|Percentage Change from Baseline in LDL cholesterol Friedewald by PEG|Baseline, Week 2 and Week 4|The safety analysis set included all participants who receive at least 1 dose of study medication.|||Perecent change||Standard Deviation|Mean
2596069|NCT02215252|Secondary|Fasted Total Cholesterol Values|Percentage Change from Baseline in Fasted Total Cholesterol values|Baseline, Week 2 and Week 4|The safety analysis set included all participants who receive at least 1 dose of study medication.|||Percent change||Standard Deviation|Mean
2596070|NCT02215252|Secondary|Number of Participants With Laboratory Test Values of Potential Clinical Importance|The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis and some other tests.|Screening, Day 1, Day 15 and Day 29|The safety analysis set included all participants who receive at least 1 dose of study medication.|||Participants|||Number
2596071|NCT02215252|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect.|Screening to Day 36, and Day 64|The safety analysis set included all participants who receive at least 1 dose of study medication.|||Participants|||Number
2596072|NCT02215252|Secondary|Number of Days Participants Take Rescue Medication|Number of days participants take rescue medication per week.|Baseline, Week 1, Week 2, Week 3 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||days||Standard Deviation|Mean
2596073|NCT02215252|Secondary|Total Amount of Rescue Medication Per Week|Total amount of rescue medication participants take per week|Baseline, Week 1, Week 2, Week 3, and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||mg||Standard Deviation|Mean
2596075|NCT02215252|Secondary|Patient's Global Impression of Change Score (PGIC).|"Participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse) at week 4. The PGIC was combined to produce a 3-point scale, Improved, No Change and Worse."|Baseline, Week 2, and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Number of participants|||Number
2596076|NCT02215252|Secondary|Neuropathic Pain Symptom Inventory (NPSI) - Total Score|Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.|Baseline, Week 2 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Unit on a scale||Standard Deviation|Mean
2596077|NCT02215252|Secondary|Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysethesia|Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.|Baseline, Week 2 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Unit on a scale||Standard Deviation|Mean
2596078|NCT02215252|Secondary|Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain|Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.|Baseline, Week 2 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Unit on a scale||Standard Deviation|Mean
2596079|NCT02215252|Secondary|Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain|Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.|Baseline, Week 2, and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Unit on a scale||Standard Deviation|Mean
2596080|NCT02215252|Secondary|Neuropathic Pain Symptom Inventory (NPSI) - Pressing (Deep) Spontaneous Pain|Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.|Baseline, Week 2 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Unit on a scale||Standard Deviation|Mean
2596081|NCT02215252|Secondary|Neuropathic Pain Symptom Inventory (NPSI) - Burning (Superficial) Spontaneous Pain|Participants rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain.|Baseline, Week 2, and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Unit on a scale||Standard Deviation|Mean
2596082|NCT02215252|Secondary|Responder Rate Based on a 50% Improvement in Mean Pain Response Using the Daily Pain NRS Score|Percentage of participants that received ≥50% improvement from baseline in mean pain response (from the daily pain diary).|Baseline, Week 1, Week 2, Week 3, and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
2596083|NCT02215252|Secondary|Responder Rate Based on a 30% Improvement in Mean Pain Response Using the Daily Pain NRS Score|Percentage of participants that received ≥30% improvement from baseline in mean pain response (from the daily pain diary).|Baseline, Week 1, Week 2, Week 3 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
2596084|NCT02215252|Primary|Daily Pain Numeric Rating Scale (NRS)|The endpoint average pain score, based on the mean of the last 7 days' daily pain numeric rating scale (NRS) scores at (NRS is an 11-point scale where 0 = no pain and 10 = worst possible pain) from the daily pain diaries while receiving study medication during the treatment period.|Baseline, Week 1, Week 2, Week 3 and Week 4|The full analysis set included all randomized participants who received at least one dose of study medication.|||Unit on a scale||Standard Deviation|Mean
2596085|NCT02215200|Primary|Change in Area Under the Stimulated C-peptide Curve From Baseline to 12 Months.|"The C-peptide 2 hour area under the curve (AUC) mean is calculated at baseline and 12 months and measured in nmol/L. The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the AUC mean and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis)."|-10, 0 15, 30, 60, 90, and 120 minutes post-dose at baseline and 12 months||||nmol/L||95% Confidence Interval|Mean
2596086|NCT02215161|Secondary|Incidence of Serious Adverse Events|Incidence of serious adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0|Up to 3 years after treatment start||||events|||Number
2606283|NCT02101515|Other Pre-specified|Neonatal Sepsis (Neonate)|Diagnosed by neonatology, one neonate was analyzed per mother|until neonatal discharge, usually < 5 days||||Participants|||Count of Participants
2596087|NCT02215161|Secondary|Time to Confirmed Development of >= 2 New Bone Lesions That Cannot be Attributable to Bone Scan Flare|Defined as time interval between the date of treatment initiation and the date of documented new lesions. Evaluation criteria is defined by the PSAWG2 (Prostate-Specific Antigen Working Group 2) criteria for bone scan evaluation. The time will be 'backdated' to when the >= 2 new lesions were detected if a second scan is done to confirm progression.|At week 8, 16, 24, and every 12 weeks thereafter up to 3 years after treatment start|The study was terminated due to unacceptable toxicity. Data was not collected.||||||
2596088|NCT02215161|Secondary|Serum Selinexor Levels|Serum selinexor trough levels as a function of dose and time since last dose|At day 1 of course 1, each treatment day until end of treatment up to 3 years|The study was terminated due to unacceptable toxicity. Data was not collected.||||||
2596089|NCT02215161|Secondary|Reduction in Pain for Symptomatic Patients, Measured Using the Brief Pain Inventory (BPI), Short Form|"The effect of selinexor on persistent pain associated with bone metastasis, measured using the Brief Pain Inventory (BPI), Short Form. 0 denotes ''no pain'' and 10, ''pain as bad as you can imagine."|At baseline and day 1 of every following cycle until end of treatment or 3 years after study start|The study was terminated due to unacceptable toxicity. Only baseline data was collected.|||units on a scale||Full Range|Median
2596090|NCT02215161|Secondary|PSA Decline of ≥50% at 12 Weeks Post Therapy Initiation|The number of patients experiencing a PSA decline from baseline of at least 50% in PSA at 12 weeks following the initiation of study therapy.|At 12 weeks post therapy initiation||||Participants|||Count of Participants
2596091|NCT02215161|Secondary|Comparison of Leukocyte Exportin 1 (XPO-1) and Macrophage Inhibitory Cytokine-1 (MIC-1) Gene Expression Levels Pre- and Post-Selinexor Treatment|Total RNA isolated from leukocytes of patients will be used for quantitative polymerase chain reaction analysis (qPCR) in order to compare expression levels of XPO-1 and MIC-1 as a function of selinexor dose and total time on treatment.|On days 1 and 15 of course 1 and on day 1 of courses 2 and 3|The study was terminated due to unacceptable toxicity. Data was not collected.||||||
2596092|NCT02215161|Secondary|Incidence of Non-serious Adverse Events|Incidence of non-serious adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0|Up to 3 years after treatment start||||events|||Number
2596093|NCT02215161|Secondary|Time to PSA Progression|Time between the first evaluation at which the response criteria are met and the first documentation of PSA (Prostate-Specific Antigen) progression or death. Progression is defined as a rise in PSA of 50% above nadir value or 25% above baseline if there is no decline.|Time between the first evaluation at which the response criteria are met and the first documentation of PSA progression or death or up to 3 years||||weeks||Full Range|Median
2596094|NCT02215161|Secondary|Abiraterone Resistance Status (Primary Versus Acquired)|Comparison of radiographic progression free survival between patients with primary abiraterone resistance and acquired abiraterone resistance using a Cox proportional hazards model.|At baseline|The study was terminated due to unacceptable toxicity. Data on resistance type was not collected.||||||
2596095|NCT02215161|Primary|Radiographic Progression Free Survival (rPFS)|Defined as the time from study start until one of the following events occurs: >= 2 new bone lesions on technetium bone scan; Response Evaluation Criteria in Solid Tumors (RECIST)-defined tumor progression; clinical deterioration requiring a change in prostate cancer therapy, or at clinician discretion; surgery or radiation to treat a prostate cancer related indication; or death from any cause.|From study start up to 3 years||||weeks||Full Range|Median
2596096|NCT02215070|Other Pre-specified|Evaluate GI Toxicity Assessment by Video Capsule Endoscopy.|Exploratory outcome-Video capsule endoscopy will be performed in a subset of ten study participants on the last day study drug is administered. Images will be examined for evidence of the four following types of abnormalities: reddened/edema/villous blunting, erosion, ulcer and stenosis.|14 days|||||||
2596097|NCT02215070|Other Pre-specified|Citrulline and Fecal Calprotectin Levels Will be Measured|Exploratory outcome-These levels will be evaluated as biomarkers of GI tract health and function in SCT patients and the correlation between these biomarkers and GI toxicity.|100 days|||||||
2596098|NCT02215070|Secondary|Disease Free Survival Compared to Historical Controls|Rate of disease free survival of participants at one year post transplant|1 year|||||||
2596099|NCT02215070|Secondary|Overall Survival Compared to Historical Controls|Rate of overall survival of participants at one year post transplant|1 year|||||||
2596100|NCT02215070|Secondary|Maximum Severity of Chronic GVHD Compared to Historical Controls|Assess maximum severity of chronic GVHD scored as none, mild, moderate or severe using 2014 NIH Consensus Criteria|1 year|||||||
2596101|NCT02215070|Secondary|Incidence of Chronic GVHD Compared to Historical Controls|Measure the number of participants who experience chronic GVHD|1 year|||||||
2596102|NCT02215070|Secondary|Maximum Severity of Acute GVHD Compared to Historical Controls|Assess maximum severity of acute GVHD scored as stage 1 (least severe) through stage 4 (most severe) using BMT CTN, 2013 standards|100 days||||units on a scale||Inter-Quartile Range|Median
2596103|NCT02215070|Secondary|Percentage of Acute GVHD|Number of participants who experience acute GVHD|100 days||||Participants|||Count of Participants
2596104|NCT02215070|Primary|Percentage of GI Toxicity From the Preparatory Regimen and the GVHD Prophylaxis in Stem Cell Transplantation (SCT) Patients Who Are Treated With Pasireotide|Number of participants who experience grades III-IV GI toxicity|30 Days||||Participants|||Count of Participants
2596105|NCT02214628|Primary|Number of Subjects With Serious Adverse Events|Number of subjects with serious adverse events in each arm|2 years||||Participants|||Count of Participants
2596106|NCT02214628|Primary|Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects)|Number of subjects on either arm with non-serious adverse events (reported by >5% of subjects)|2 years||||Participants|||Count of Participants
2596107|NCT02214615|Secondary|Carbamazepine Affects Mean Duration of Pain Episode||15 days||||minutes|||Number
2596108|NCT02214615|Primary|Carbamazepine Affects Pain in Patients With S241T NaV1.7 IEM Mutation||15 days||||minutes|||Number
2596159|NCT02214121|Secondary|Number of Vaso-occlusive Crises - Part B||During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).|All patients randomised in Part B were to be included in the efficacy analysis set (EAS). Patients were analysed according to their randomised study medication.|||Number of events||Standard Deviation|Mean
2596109|NCT02214420|Primary|Sustained Viral Response|Comparison of sustained virologic response at 12 weeks post-treatment (SVR12) in 2 arms of IFN-II patients: one receiving 12 weeks of simeprevir (SMV) (150mg QD)+ sofosbuvir (SOF) (400mg QD) and the second receiving to SMV (150mg QD)+SOF (400mg QD)+weight-based ribavirin (RBV) 1000-1200 mg/day. SVR12 is defined as a patient having undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks post-treatment. Achieving SVR12 is generally indicative of hepatitis C infection being cured.|12 weeks||||Participants|||Count of Participants
2596110|NCT02214277|Secondary|Captured Debris Histopathology (Observational)||Post-procedure|Only Test Arm patients had debris samples collected. Only samples with evaluable filters were used in the analysis.|||Participants|||Count of Participants
2596111|NCT02214277|Primary|Patients With Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days|Primary Safety Endpoint: MACCE (all death, all stroke, and acute kidney injury class 3 within 72 hours or discharge, whatever occurs first) at 30 days compared to a historical performance goal of 18.3%.|30 Days Post-Procedure|Safety Arm and Test Arm. ITT with imputation.|||Participants|||Count of Participants
2596112|NCT02214277|Primary|Reduction in Median Total New Lesion Volume in Protected Territories Between Test and Control Arms as Assessed by DW-MRI at Day 2-7 Post-procedure.|Total new lesion volume is defined as the sum of all diffusion-positive new cerebral lesions in post-TAVR DW-MRI relative to the pre-TAVR DW-MRI scans. Protected territories are defined as brain territories uniquely perfused by the vessels protected by the Sentinel System, namely the left and right carotid arteries, and the right vertebral artery.|Day 2-7 Post-Procedure|ITT with Imputation. Test Arm compared to the Control Arm.|||mm3||Inter-Quartile Range|Median
2596113|NCT02214238|Secondary|PAP Compliance|Participants therapy utilisation will be compared between the two devices using the device data download, and the independent pressure-flow logger.|After 1 night in the sleep lab and 3 weeks use of the device in the home.|The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 31 had usable data for analysis after using both devices. Compliance was compared between devices independent of which order the participants used each device.|||Minutes||Standard Deviation|Mean
2596114|NCT02214238|Secondary|PAP Treatment Comfort|Participants will be administered comfort questionnaires regarding the comfort of all devices. The range of responses is 1 to 5 with 1 being very uncomfortable to 5 being very comfortable.|After 1 night in the sleep lab and 3 weeks use of the device in the home.|The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 35 had usable data for analysis after using each device. PAP treatment comfort was compared between devices independent of which order the participants used each device.|||Units on a Scale||Full Range|Median
2596115|NCT02214238|Primary|PAP Treatment Efficacy|The participants apnea hypopnea index (AHI) will be assessed using the PSG data, device download data and the independent pressure-flow logger. The apnea-hypopnea index is the total number of sleep disordered breathing events divided by total sleep time.|After 1 night in the sleep lab and 3 weeks use of the device in the home.|The overall number of participants analyzed is represented independent to which arm the participant started. Out of 49 total patients at baseline, 37 had usable data for analysis after using each device. AHI was compared between devices independent of which order the participants used each device.|||Events per hour||Standard Deviation|Mean
2596116|NCT02214225|Secondary|The Frequency of Serious Adverse Events (SAEs) for 6 Months Following Vaccination.|The number of participants reporting Serious Adverse Events for 6 months following vaccination.|For 6 months following vaccination.|The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.|||participants|||Number
2596117|NCT02214225|Secondary|The Frequency and Severity of Unsolicited AEs.|The overall number of subjects experiencing at least one event of an unsolicited AE, and the overall number of subjects with at least one severe (grade 3) unsolicited AE.|For 28 days following vaccination.|The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.|||participants|||Number
2596118|NCT02214225|Secondary|The Frequency of Cellulitis-like Reaction and Cellulitis.|The number of subjects experiencing at least one episode of each event.|For 28 days following vaccination.|The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.|||participants|||Number
2596119|NCT02214225|Secondary|The Frequency and Severity of Solicited Local and Systemic Adverse Events (AEs).|The overall number of subjects experiencing at least one event of a local and systemic solicited AE, and the overall number of subjects with at least one severe (grade 3) local and systemic solicited AE.|For 7 days following vaccination.|The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.|||participants|||Number
2596120|NCT02214225|Secondary|Seroconversion Rates|The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bio CSL TIV-2 was assessed in terms of the seroconversion rate, ie, percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer. Data presented in age cohorts (per protocol population).|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||percentage of participants||95% Confidence Interval|Number
2596189|NCT02213510|Secondary|Surgeon Wound Evaluation Scale (WES)|At 2 weeks post-procedure, the Wound Evaluation Scale was measured. The scale is based from 0 (representing normal skin) to 100 (representing a poor scar).|2 weeks||||units on a scale||Standard Deviation|Mean
2596121|NCT02214225|Secondary|Seroprotection Rates Prevaccination and Postvaccination.|The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of percentage of subjects with a HI titer ≥40 (seroprotection rates) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||percentage of participants||95% Confidence Interval|Number
2596122|NCT02214225|Secondary|Geometric Mean Fold Titer Change From Prevaccination to Postvaccination.|The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 assessed in terms of Geometric Mean Fold Increase (GMFI, defined as the geometric mean of the fold increases of postvaccination antibody titer over the prevaccination antibody titer) by Age Cohort (Per Protocol Population).|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||Fold Change Titer (GMFI)||95% Confidence Interval|Geometric Mean
2596123|NCT02214225|Secondary|Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination.|The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of geometric mean HI titers (GMT) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||Titer||95% Confidence Interval|Geometric Mean
2596124|NCT02214225|Secondary|Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) for This Strain, Overall and by Age Cohort (Per Protocol Population)|Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The SCR difference was calculated as bioCSL QIV SCR minus bioCSL TIV SCR, which is the reverse of how it was calculated for the non-inferiority analyses. For the SCR comparison superiority was demonstrated if the lower limit of the two-sided 95% CI of the difference of the seroconversion rates was greater than 0 for each B strain in QIV compared with the corresponding B strain not contained in each TIV.|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||percentage of participants analyzed|||Number
2596125|NCT02214225|Secondary|Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by the GMT (Statistical Analysis: GMT Ratio) for This Strain, Overall and by Age Cohort (Per Protocol Population).|"Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.~(GMT dispersion values are based on unadjusted GMT values.)"|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||Titer||Full Range|Geometric Mean
2596126|NCT02214225|Secondary|The Seroconversion Rate (SCR) (Statistical Analyses: Difference in SCR) for Each Virus Strain, Assessed Separately Within Each Age Group (18 to < 65 Years and ≥ 65 Years of Age) (Per Protocol Population).|Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age) through assessment of SCR differences as described for the primary endpoint.|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||percentage of participants analyzed|||Number
2596127|NCT02214225|Secondary|Postvaccination GMT (Statistical Analyses: GMT Ratios) Assessed Separately Within Each Age Group (18 Through 64 Years and ≥ 65 Years of Age) (Per-Protocol Population).|"Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.~Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age) through assessment of GMT ratios as described for the primary endpoint."|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||Titer||Full Range|Geometric Mean
2596128|NCT02214225|Primary|The Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) in Subjects Aged ≥18 Years.|SCR (defined as the percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination HI titer ≥ 1:10 and a 4-fold increase in postvaccination HI titer) was determined for each virus strain included in the vaccines: bioCSL TIV-1 and bioCSL TIV-2 SCRs were pooled for analysis of the A strains. The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||percentage of participants|||Number
2596129|NCT02214225|Primary|Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population).|Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.|21 days after vaccination.|The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.|||Titer||Full Range|Geometric Mean
2596130|NCT02214186|Primary|Postoperative Renal Dysfunction Evaluated by the Acute Kidney Injury Network (AKIN) Index|Renal dysfunction was stratified by the Acute Kidney Injury Network (AKIN) index in three stages, in terms of creatinine increase from baseline: stage 1 included an interval of 150-200%, stage 2 200%-300%, and stage 3 more than 300% or hemodialysis|Postoperative renal dysfunction||||participants|||Number
2596131|NCT02214186|Secondary|Activated Partial Thromboplastin Time in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section|"Compare activated partial thromboplastin time (APPT) and relation with control (R) in the restrictive and liberal groups.~APPT is a laboratory test that evaluates the efficiency of the intrinsic pathway of coagulation. The unit of measure is seconds and the results are presented as relation (R) with control."|preoperative, first and second day postoperative|The values are expressed in seconds and presented as a ration (R) with control patients.|||ratio||Standard Deviation|Mean
2596132|NCT02214186|Other Pre-specified|Urine Output During Cesarean Section in Severe Pre-eclampsia|Urine output during cesarean section in severe pre-eclampsia under two different regimes of hydration (restrictive and liberal)|urine output during cesarean section (an average of 60 minutes)||||ml/h||Inter-Quartile Range|Median
2596133|NCT02214186|Secondary|International Normalized Ratio (INR) of Prothrombin Time (PT) in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section|"Compare International Normalized Ratio (INR) of Prothrombin Time (PT) in the restrictive and liberal groups in preoperative, first and second day postoperative.~PT is expressed in seconds and the entered values represented the INR of PT among study participants and a control population."|preoperative, first and second day postoperative|The values are expressed in seconds and presented as a ration (INR) with control patients.|||ratio||Inter-Quartile Range|Median
2596134|NCT02214186|Secondary|Platelets in Restrictive Fluid Management of Severe Preeclampsia|Compare platelets count in the restrictive and liberal groups during the first and second post-operative days.|preoperative, first and second day postoperative||||thrombocytes/mm3||Standard Deviation|Mean
2596135|NCT02214186|Secondary|Proteinuria in Severe Pre-eclampsia Submitted to Cesarean Section Under Different Regimes of Hydration|Proteinuria in severe pre-eclampsia submitted to cesarean section under different regimes of hydration. Analyses in pre-operative and post-operative period.|Proteinuria in severe pre-eclampsia in in pre-operative and post-operative period||||g/dl||Inter-Quartile Range|Median
2596136|NCT02214186|Secondary|Cystatin C as New Marker of Renal Injury in Preeclampsia|Evaluate new marker of renal injury (Cystatin C) in the specific population of patients with severe preeclampsia, comparing the values of first and second postoperative days to baseline.|preoperative, first and second day postoperative||||mg/L||Standard Deviation|Mean
2596137|NCT02214186|Secondary|Neutrophil Gelatinase-associated Lipocalin (NGAL) as New Marker of Renal Injury in Preeclampsia|Evaluate new marker of renal injury (NGAL) in the specific population of patients with severe preeclampsia, comparing the values of first and second postoperative days to baseline.|preoperative, first and second day postoperative||||mg/L||Inter-Quartile Range|Median
2596138|NCT02214186|Primary|Renal Function in Severe Preeclampsia With Restrictive Fluid Therapy|Renal function evaluated through creatinine levels in three moments: preoperative, first and second postoperative days.|preoperative, first and second day postoperative|Were included in the analysis the patients who violated the protocol and lost follow-up (intention to treat analysis)|||mg/dl||Inter-Quartile Range|Median
2596139|NCT02214147|Secondary|Dose-normalized Trough Concentration of Alisertib on Cycle 1 Day 14|A single blood sample will be collected pre-dose on Cycle 1 Day 14. The concentration of alisertib was determined in the plasma sample and dose-normalized.|Pre-dose on Day 14 of Cycle 1|Data was not collected, as many participants dropped out of the study prior to Day 14 trough concentration collection.||||||
2596140|NCT02214147|Secondary|AUClast: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alisertib Metabolites M1 and M2|The area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-last) of the alisertib metabolites M1 and M2 was determined from the concentration-time curve of each participant using non-compartmental methods.|Cycle 1 Day 1 Pre-dose and, and at multiple timepoints (up to 168 hours) post-dose|Participants from the PK-evaluable population, all participants who had completed protocol-specified dosing and PK assessment in Cycle 1 with sufficient dosing and PK data to reliably estimate PK parameters, with data available for analysis.|||h*nmol/L||Standard Deviation|Mean
2596141|NCT02214147|Secondary|Tmax: Time of First Occurrence of Cmax for Alisertib Metabolites M1 and M2||Cycle 1 Day 1 Pre-dose and, and at multiple timepoints (up to 168 hours) post-dose|PK-evaluable population was defined as all participants who had completed protocol-specified dosing and PK assessment in Cycle 1 with sufficient dosing and PK data to reliably estimate PK parameters.|||hours||Full Range|Median
2596142|NCT02214147|Secondary|Cmax: Maximum Observed Plasma Concentration for Alisertib Metabolites M1 and M2||Cycle 1 Day 1 Pre-dose and, and at multiple timepoints (up to 168 hours) post-dose|PK-evaluable population was defined as all participants who had completed protocol-specified dosing and PK assessment in Cycle 1 with sufficient dosing and PK data to reliably estimate PK parameters.|||nmol/L||Standard Deviation|Mean
2596143|NCT02214147|Secondary|Percentage of Participants With Clinically Significant Vital Signs|Vital signs include measurements of sitting diastolic and systolic blood pressure, heart rate, and temperature. Any vital signs determined by the investigator to be clinically significant were recorded as AEs.|Baseline to the end of the study (Up to 312 days)|Safety population was defined as all participants who received at least 1 dose of alisertib.|||percentage of participants|||Number
2596144|NCT02214147|Secondary|Percentage of Participants With Clinically Significant Laboratory Values|Laboratory assessments include serum chemistry and hematology. An abnormal laboratory value was assessed as an AE if that value led to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from baseline.|Baseline to the end of the study (Up to 312 Days)|Safety population was defined as all participants who received at least 1 dose of alisertib.|||percentage of participants|||Number
2596145|NCT02214147|Secondary|Percentage of Participants Who Experienced at Least 1 Serious Adverse Event|A serious adverse event is any untoward medical occurrence or effect that at any dose of a drug results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically important due to other reasons than the above mentioned criteria.|Baseline to 30 days after last dose (Up to 312 Days)|Safety population was defined as all participants who received at least 1 dose of alisertib.|||percentage of participants|||Number
2596146|NCT02214147|Secondary|Percentage of Participants Who Experienced at Least 1 Treatment-Emergent Adverse Event|An adverse event is any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline to 30 days after last dose (Up to 312 Days)|Safety population was defined as all participants who received at least 1 dose of alisertib.|||percentage of participants|||Number
2596147|NCT02214147|Primary|Unbound AUC0-∞: Area Under the Concentration-Time Curve From Time 0 to Infinity for Alisertib||Cycle 1 Day 1 Pre-dose and, and at multiple timepoints (up to 168 hours) post-dose|Participants from the PK-evaluable population, all participants who had completed protocol-specified dosing and PK assessment in Cycle 1 with sufficient dosing and PK data to reliably estimate PK parameters, with data available for analysis.|||h*nmol/L||Standard Deviation|Mean
2596148|NCT02214147|Primary|Unbound AUClast: Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alisertib||Cycle 1 Day 1 Pre-dose and, and at multiple timepoints (up to 168 hours) post-dose|Participants from the PK-evaluable population, all participants who had completed protocol-specified dosing and PK assessment in Cycle 1 with sufficient dosing and PK data to reliably estimate PK parameters, with data available for analysis.|||h*nmol/L||Standard Deviation|Mean
2596149|NCT02214147|Primary|Unbound Cmax: Maximum Observed Plasma Concentration for Alisertib||Cycle 1 Day 1 Pre-dose and, and at multiple timepoints (up to 168 hours) post-dose|Pharmacokinetic (PK)-evaluable population was defined as all participants who had completed protocol-specified dosing and PK assessment in Cycle 1 with sufficient dosing and PK data to reliably estimate PK parameters.|||nmol/L||Standard Deviation|Mean
2596150|NCT02214121|Other Pre-specified|Haemorrhagic Events - Part B||During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).|All patients who received at least one dose of randomised study drug, ticagrelor or placebo, will be included in the SAF for Part B. Analysis on the SAF was based on the study medication actually received. Erroneously treated patients will be accounted for in the actual treatment group.|||Number of events|||Number
2596151|NCT02214121|Other Pre-specified|Haemorrhagic Events - Part A||From randomisation to Part A (week 0) through Visit 4 (week 2)|All patients who received at least one single dose of ticagrelor were included in the safety population (SAF) for Part A. Analysis on the SAF was based on the study medication actually received.|||Number of events|||Number
2596152|NCT02214121|Secondary|Percentage of Days of Absence From School or Work (Age >=6) - Part B||During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).|All patients randomised in Part B were to be included in the efficacy analysis set (EAS). Patients were analysed according to their randomised study medication.|||Percentage of days||Standard Deviation|Mean
2596153|NCT02214121|Secondary|Percentage of Days of Opioid Analgesic Use (Age >=4) - Part B||During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).|All patients randomised in Part B were to be included in the efficacy analysis set (EAS). Patients were analysed according to their randomised study medication.|||Percentage of days||Standard Deviation|Mean
2596154|NCT02214121|Secondary|Percentage of Days of Analgesic Use (Age >= 4) - Part B||During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).|All patients randomised in Part B were to be included in the efficacy analysis set (EAS). Patients were analysed according to their randomised study medication.|||Percentage of days||Standard Deviation|Mean
2596155|NCT02214121|Secondary|Mean Intensity of Pain (Age >=4) - Part B|Pain measured using the Faces Pain Scale, range 0-10 (0, 2, 4, 6, 8, 10), where 0 is no pain|During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).|All patients randomised in Part B were to be included in the efficacy analysis set (EAS). Patients were analysed according to their randomised study medication.|||Mean score on scale||Standard Deviation|Mean
2596156|NCT02214121|Secondary|Percentage of Days With Pain (Age >=4) - Part B|Pain measured using the Faces Pain Scale, range 0-10 (0, 2, 4, 6, 8, 10), where 0 is no pain|During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).|All patients randomised in Part B were to be included in the efficacy analysis set (EAS). Patients were analysed according to their randomised study medication.|||Percentage of days||Standard Deviation|Mean
2596157|NCT02214121|Secondary|Percentage of Days Hospitalized for Vaso-occlusice Crisis or Other Complications of Sickle Cell Disease - Part B||During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).|All patients randomised in Part B were to be included in the efficacy analysis set (EAS). Patients were analysed according to their randomised study medication.|||Percentage of days||Standard Deviation|Mean
2596158|NCT02214121|Secondary|Number of Vaso-occlusive Crises Requiring Hospitalization or Emergency Department Visits - Part B||During 4 weeks of study treatment starting from randomization in Part B (week 2) up to 4 weeks (week 6).|All patients randomised in Part B were to be included in the efficacy analysis set (EAS). Patients were analysed according to their randomised study medication.|||Number of events||Standard Deviation|Mean
2606651|NCT02097472|Secondary|Fold Change in IgG Response to PspA-Fam1 (ELISA)|Measured using ELISA|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
2596160|NCT02214121|Secondary|Oral Clearance (CL/F) - Part B|The PK parameter presented was derived using a model based analysis and not from a non-compartmental (NCA) analysis.|PK measurements (up to 4 hours post-dose) are taken after 4 weeks of double blind treatment at the end of Part B.|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one dose of randomised study drug, ticagrelor or placebo, will be included in the SAF for Part B. Analysis on the SAF was based on the study medication actually received.|||L/h||Standard Deviation|Geometric Mean
2596161|NCT02214121|Secondary|Oral Clearance (CL/F) - Part A|The PK parameter presented were derived using a model based analysis and not from a non-compartmental (NCA) analysis.|PK measurements (up to 8 hours post-dose) are taken in conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7) and after repeated dosing at Visit 4 (Day 14).|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one single dose of ticagrelor were included in the safety population (SAF) for Part A. Analysis on the SAF was based on the study medication actually received.|||L/h||Standard Deviation|Geometric Mean
2596162|NCT02214121|Secondary|Assessment of AR-C124910XX Concentration - Part B|AR-C124910XX is the active metabolite of Ticagrelor|PK measurements (up to 4 hours post-dose) are taken after 4 weeks of double blind treatment at the end of Part B.|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one single dose of ticagrelor were included in the safety population (SAF) for Part A. Analysis on the SAF was based on the study medication actually received.|||ng/mL||Standard Deviation|Geometric Mean
2596163|NCT02214121|Secondary|Assessment of AR-C124910XX Concentration - Part A|AR-C124910XX is the active metabolite of Ticagrelor|In conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7), after repeated dosing at Visit 4 (Day 14). Up to 8h post-dose (6h following protocol amendment, no pre-dose) Visit 2 and 3, up to 2h Visit 4 (pre-dose, 1h added following amendment)|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one single dose of ticagrelor were included in the safety population (SAF) for Part A. Analysis on the SAF was based on the study medication actually received.|||ng/mL||Standard Deviation|Geometric Mean
2596164|NCT02214121|Secondary|Assessment of Ticagrelor Concentration - Part B||PK measurements (up to 4 hours post-dose) are taken after 4 weeks of double blind treatment at the end of Part B.|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one single dose of ticagrelor were included in the safety population (SAF) for Part A. Analysis on the SAF was based on the study medication actually received.|||ng/mL||Standard Deviation|Geometric Mean
2596165|NCT02214121|Secondary|Assessment of Ticagrelor Concentration - Part A||In conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7), after repeated dosing at Visit 4 (Day 14). Up to 8h post-dose (6h following protocol amendment, no pre-dose) Visit 2 and 3, up to 2h Visit 4 (pre-dose, 1h added following amendment)|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one single dose of ticagrelor were included in the safety population (SAF) for Part A. Analysis on the SAF was based on the study medication actually received.|||ng/mL||Standard Deviation|Geometric Mean
2596166|NCT02214121|Primary|Area Under the Plasma Concentration Time Curve (AUC) - Part B|The PK parameter presented was derived using a model based analysis and not from a non-compartmental (NCA) analysis.|PK measurements (up to 4 hours post-dose) are taken after 4 weeks of double blind treatment at the end of Part B.|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one dose of randomised study drug, ticagrelor or placebo, will be included in the SAF for Part B. Analysis on the SAF was based on the study medication actually received.|||ng*h/mL||Standard Deviation|Geometric Mean
2596167|NCT02214121|Primary|Area Under the Plasma Concentration Time Curve (AUC) - Part A|The PK parameter presented was derived using a model based analysis and not from a non-compartmental (NCA) analysis.|PK measurements (up to 8 hours post-dose) are taken in conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7) and after repeated dosing at Visit 4 (Day 14).|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one single dose of ticagrelor were included in the safety population (SAF) for Part A. Analysis on the SAF was based on the study medication actually received.|||ng*h/mL||Standard Deviation|Geometric Mean
2596168|NCT02214121|Primary|Maximum Plasma Concentration (Cmax) - Part B||PK measurements (up to 4 hours post-dose) are taken after 4 weeks of double blind treatment at the end of Part B.|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one dose of randomised study drug, ticagrelor or placebo, will be included in the SAF for Part B. Analysis on the SAF was based on the study medication actually received.|||ng/mL||Standard Deviation|Geometric Mean
2596169|NCT02214121|Primary|Maximum Plasma Concentration (Cmax) - Part A||PK measurements (up to 8 hours post-dose) are taken in conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7) and after repeated dosing at Visit 4 (Day 14).|The PK analysis set is a subset of the safety analysis set, including all patients having at least one PK variable calculated. All patients who received at least one single dose of ticagrelor were included in the safety population (SAF) for Part A. Analysis on the SAF was based on the study medication actually received.|||ng/mL||Standard Deviation|Geometric Mean
2596170|NCT02214121|Primary|P2Y12 Reaction Units (PRU) - Part B||PRU measurements are taken after 4 weeks of double blind treatment at the end of Part B.|The PD analysis set is a subset of the safety analysis set, including all patients having at least one PRU measured. All patients who received at least one dose of randomised study drug, ticagrelor or placebo, will be included in the SAF for Part B. Analysis on the SAF was based on the study medication actually received.|||P2Y12 reaction units||Standard Deviation|Mean
2596190|NCT02213510|Primary|Wound Healing as Determined by the CVAS (Cosmetic Visual Analogue Scale)|Based on photographs taken of scars taken at 3 months following CIED procedure. The CVAS scale is measured from 0mm (representing best scar) to 100 mm (representing worst scar).|3 Months|Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.|||mm||Standard Deviation|Mean
2596171|NCT02214121|Primary|P2Y12 Reaction Units (PRU) - Part A||PRU measurements are taken in conjunction with single doses at Visit 2 (Day 0) and Visit 3 (Day 7) and after repeated dosing at Visit 4 (Day 14). Up to 8 hours post-dose (6 hours following protocol amendment) Visit 2 and 3, and up to 2 hours Visit 4.|The PD analysis set is a subset of the safety analysis set, including all patients having at least one PRU measured. All patients who received at least one single dose of ticagrelor were included in the safety population (SAF) for Part A. Analysis on the SAF was based on the study medication actually received.|||P2Y12 reaction units||Standard Deviation|Mean
2596172|NCT02214017|Other Pre-specified|Blood Pressure|Diurnal blood pressure measured by Spacelab monitor, Spacelab 90207|Six months of treatment|diastolic blood pressure|||mmHg||Full Range|Median
2596173|NCT02214017|Secondary|Lipids|Total-cholesterol|Six months of treatment||||milli mols/l||Full Range|Median
2596174|NCT02214017|Primary|Glycemia|Percent of glycosylated hemoglobin, HbA1c|Six months of treatment||||percent of glycosylated hemoglobin||Full Range|Median
2596175|NCT02213926|Primary|Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) in Subjects With Previously Treated MCL.|The overall response rate (ORR) is defined as the proportion of subjects achieving either a partial remission (response) (PR) or complete response (CR) according to the Lugano Classification for NHL (Cheson 2014) as assessed by investigators, where SD stands for Stable Disease, PD for Progressive Disease and NE for Not Evaluable.|Participants will be followed every 28 days or until progression of disease or start of another anti-cancer treatment for at least 1 year||||Participants|||Count of Participants
2596176|NCT02213900|Secondary|Efficacy of Low-dose Haloperidol in Reducing Cognitive Impairment at Post-operative Follow-up|Test the efficacy of low dose haloperidol in reducing cognitive impairment at post-operative follow-up among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo. Cognitive status is assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). The RBANS measures attention, language, visuospatial/constructional abilities, and memory. It is made up of 12 subtests. The subtests produce 5 index scores and a total scale score. All the subtest scores are summed to calculate a Total Index score. The Total Index score is presented. The Total Index score scale is from 0-100 with higher scores indicating less cognitive impairment.|Up to 3 months after hospital discharge on average.||||Units on a scale||Standard Deviation|Mean
2596177|NCT02213900|Secondary|Efficacy of Low-dose Haloperidol in Reducing ICU and Hospital Length of Stay|Test the efficacy of low dose haloperidol in reducing ICU and hospital length of stay among patients who are status post esophagectomy or pneumonectomy compared to placebo.|Date of hospital admission through date of hospital discharge, up to 3 weeks on average.||||Days||Standard Deviation|Mean
2596178|NCT02213900|Secondary|Efficacy of Low-dose Haloperidol in Reducing Days With Delirium|Test the efficacy of low dose haloperidol in reducing the number of days with delirium among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo.|Up to 30 days||||Days with Delirium||Standard Deviation|Mean
2596179|NCT02213900|Primary|Efficacy of Low-dose Haloperidol in Reducing Delirium Incidence|Test the efficacy of low dose haloperidol in reducing delirium incidence among patients who are status post esophagectomy, pneumonectomy or thoracotomy compared to placebo.|Up to 30 days||||Participants|||Count of Participants
2596180|NCT02213666|Primary|Intracardiac and Transesophageal Echo Results|The right atrial appendage (RAA) and left atrial appendage (LAA) will be assessed for the presence or absence of intracardiac thrombi with the Siemens AcuNav Ultrasound catheter. This is also performed with the standard of care modality, transesophageal echocardiography (TEE) with both operators blinded to the opposing imaging modality. The presence of LAA thrombi requires cancellation of the clinical procedure. After a determination has been made by both operators regarding the presence or absence of thrombi will investigators be unblinded to the opposing imaging modality result. If intracardiac thrombi was detected, the procedure was cancelled according to standard clinical guidelines and practice. There is no follow-up data collected. Participants were followed during enrollment and the clinical ablation procedure which is an average of a 6 hour period.|Time of Clinical Procedure Only (Average 6 hours)||||participants|||Number
2596181|NCT02213510|Secondary|Patient Incision Pain|Incision pain experienced by the patient was evaluated at 3 months post-procedure. This was evaluated on a scale of 0 (least pain) to 10 (worst pain).|3 months||||units on a scale||Standard Deviation|Mean
2596182|NCT02213510|Secondary|Patient Incision Pain|At 2 week post-procedure, incision pain was evaluated on a scale 0 to 10 (worst pain).|2 weeks||||units on a scale||Standard Deviation|Mean
2596183|NCT02213510|Secondary|Patient Incision Pain|At the discharge visit, patients evaluated their level of pain at the incision site based on a scale 1 (least pain) through 10 (worst pain).|1 day (discharge)||||units on a scale||Standard Deviation|Mean
2596184|NCT02213510|Secondary|Patient Rating of Scar|"At 3 months post-procedure, patients were asked to rate their scar. Scale was measured from 0 (best scar) - 10 (worst scar)~Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial."|3 months||||units on a scale||Standard Deviation|Mean
2596185|NCT02213510|Secondary|Patient Satisfaction With Scar|"Patient will complete questionnaires that includes assessments of the following:~Pain~Closure Method Comfort~Closure Method Satisfaction~Scar Satisfaction~Scar Satisfaction was measured on a scale from 1 (most satisfied) to 5 (least satisfied)~Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial."|3 months||||units on a scale||Standard Deviation|Mean
2596186|NCT02213510|Secondary|Patient Comfort|At 2 weeks post-procedure, patient comfort was evaluated with a scale 1 (most favorable) to 5 (least favorable).|2 weeks||||units on a scale||Standard Deviation|Mean
2596187|NCT02213510|Secondary|Surgeon Satisfaction With Scar|"At 3 months post-procedure, the surgeon evaluated their satisfaction on a scale from 1 to 5, 5 being the least favorable.~Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial."|3 months||||units on a scale||Standard Deviation|Mean
2596188|NCT02213510|Secondary|Surgeon Evaluation Based on the Wound Evaluation Scale (WES)|"The surgeon will complete an assessment of the following:~Closure Method Satisfaction~Scar Satisfaction~Wound Healing as judged by Wound Evaluation Scale~Scale rated on 1 (least favorable) to 6 (most favorable)~Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial."|3 Months||||units on a scale||Standard Deviation|Mean
2596192|NCT02213263|Secondary|Number of Participants Reporting Immune-Based Adverse Effects|Immune-based adverse effects included infusion related reaction (IRR), adverse events which fulfill Sampson's criteria, and adverse events which belong to the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) anaphylaxis or hypersensitivity reactions. Potential allergic and anaphylactic reactions were identified programmatically based on the criteria of Sampson et al, (2006).|Baseline up to Week 52|The Safety analysis population include all participants who received at least 1 dose of any study treatment.|||Participants|||Count of Participants
2596193|NCT02213263|Secondary|Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)|Human serum ADA samples were analyzed for the presence or absence of anti-rituximab antibodies or anti-PF-05280586 antibodies using the validated drug-specific assay with a tiered approach using screening, confirmation and titer/quantitation. Human NAb serum samples testing ADA positive were analyzed for the presence or absence of neutralizing anti-rituximab antibody and neutralizing anti-PF-05280586 antibody using the validated drug-specific assay with a tiered approach using screening, confirmation and titer/quantitation. Participants with their ADA titer >= 1.88 were considered to be ADA positive. Only participants with a positive ADA result were further tested for NAb.|Baseline up to Week 52|Safety population included all participants who received at least 1 dose of any study drug. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.|||Participants|||Count of Participants
2596194|NCT02213263|Secondary|Cluster of Differentiation (CD) 19-Positive B-Cell Counts||Baseline, Week 2, 3, 4, 5, 13, 26, 39, 52|The modified ITT (mITT) Population included all participants who were randomized and received at least 1 dose of any study drug. Here 'Number analyzed' signifies number of participants evaluable for this outcome measure at specified time points.|||Cells per microliter||Full Range|Median
2596195|NCT02213263|Secondary|Minimum Observed (Trough) Serum Concentration (Ctrough) of PF-05280586 and Rituximab-EU||Predose (within 4 hours prior to the start of dosing) on Day 1, 8, 15, and 22|The pharmacokinetic analysis set (PKAS) included participants who received at least 1 dose of any study drug and who provided at least one post-dose pharmacokinetic concentration. Here 'Number analyzed' signifies number of participants evaluable for this outcome measure at specified time points.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2596196|NCT02213263|Secondary|Maximum Observed Serum Concentration (Cmax) of PF-05280586 and Rituximab-EU||Predose (within 4 hours prior to start of infusion) on Days 1, 8, 15 and 22; within 15 minutes prior to end of infusion on Days 1 and 22|The pharmacokinetic analysis set (PKAS) included participants who received at least 1 dose of any study drug and who provided at least one post-dose pharmacokinetic concentration. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2596197|NCT02213263|Secondary|Overall Survival|Overall survival was defined as the time (in months) from date of randomization to death due to any cause. For participants who were alive, overall survival was censored at the last contact. Overall survival was calculated using Kaplan-Meier method.|From randomization until death due to any cause or up to Week 52|ITT population included all participants who were randomized.|||months||95% Confidence Interval|Median
2596198|NCT02213263|Secondary|Duration of Response (DOR)|DOR was defined as the time (in months) from date of the first documentation of overall response (CR or PR) to the first documentation of progressive disease (PD) based on central review or to death due to any cause in the absence of documented PD. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measureable disease and no new sites. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. DOR was calculated using Kaplan-Meier method.|From date of first documentation of overall response to first documentation of PD or to death due to any cause in absence of PD or up to Week 52|The response-evaluable population was defined as all randomized participants who received at least 1 dose of study drug, had adequate disease assessment at baseline, and at least 1 post baseline response assessment. Here. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2596199|NCT02213263|Secondary|Percentage of Participants With Complete Remission (CR) at Week 26|Complete Remission (CR) was defined as disappearance of all evidence of disease. CR was assessed by central review based on scans done at Week 26.|Week 26|ITT population included all participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
2596200|NCT02213263|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time (in months) from date of randomization to first progression of disease (PD) based on central review or death due to any cause in the absence of documented PD. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. PFS was calculated using Kaplan-Meier method.|From randomization until disease progression or death due to any cause or up to Week 52|ITT population included all participants who were randomized. Here. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2596201|NCT02213263|Secondary|Time to Treatment Failure (TTF)|TTF was defined as the time (in months) from date of randomization to first progression of disease based on central review, death due to any cause, or permanent discontinuation from treatment, or discontinuation from study for any reason, whichever came first. Progression was defined as any new lesion or increase by greater than or equal to (>=) 50% of previously involved sites from nadir. TTF was calculated using Kaplan-Meier method.|From randomization until disease progression, death or permanent discontinuation from treatment/study due to any reason, or up to Week 52|ITT population included all participants who were randomized. Here. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2596202|NCT02213263|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities|Criteria for clinically significant laboratory abnormalities included total bilirubin (TB) less than (<) 2*upper limit of normal (ULN), alanine aminotransferase (ALT)<3*ULN; TB<2*ULN, ALT more than (>) 3 equal to (=) *ULN; TB<2*ULN, aspartate aminotransferase (AST)<3*ULN; TB<2*ULN, AST>=3*ULN. Data for only those categories are reported for which at least one participant had clinically significant laboratory abnormality.|Baseline up to Week 52|Safety population included all participants who received at least 1 dose of any study drug. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.|||Participants|||Count of Participants
2596203|NCT02213263|Secondary|Number of Participants With Grade 3 or Higher Treatment-Related Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Grade 1=Mild, asymptomatic or mild symptoms, Grade 2=Moderate; minimal, local or noninvasive intervention indicated; Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Week 52|Safety population included all participants who received at least 1 dose of any study drug.|||Participants|||Count of Participants
2596204|NCT02213263|Secondary|Number of Participants With Grade 3 or Higher Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03|An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 1=Mild, asymptomatic or mild symptoms, Grade 2=Moderate; minimal, local or noninvasive intervention indicated, Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Week 52|Safety population included all participants who received at least 1 dose of any study drug.|||Participants|||Count of Participants
2596205|NCT02213263|Secondary|Number of Participants With Treatment Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state. Relatedness to treatment was assessed by investigator. AEs included both serious and non-serious AEs.|Baseline up to Week 52|Safety population included all participants who received at least 1 dose of any study drug.|||Participants|||Count of Participants
2596206|NCT02213263|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.|Baseline up to Week 52|Safety population included all participants who received at least 1 dose of any study drug.|||Participants|||Count of Participants
2596207|NCT02213263|Primary|Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26|ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) in accordance with the revised response criteria for malignant lymphoma (Cheson 2007). CR was defined as disappearance of all evidence of disease. PR was defined as regression of measureable disease and no new sites.|Week 26|ITT population included all participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
2596208|NCT02213250|Secondary|Number of Subjects With Thrombogenicity||From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.|The safety analysis population included All participants who received at least 1 dose of BeneFIX.|||Participants|||Number
2596209|NCT02213250|Secondary|Number of Participants With Allergic Reactions||From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.|The safety analysis population included All participants who received at least 1 dose of BeneFIX.|||Participants|||Number
2596210|NCT02213250|Secondary|Number of Participants With Inhibitor Development||From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.|The safety analysis population included All participants who received at least 1 dose of BeneFIX.|||Participants|||Number
2596211|NCT02213250|Secondary|Number of Participants With Vital Signs Post-Dose Data Met Criteria of Potential Clinical Concern (Without Regard to Baseline Abnormality)||Baseline up to 96 hours post-dose (Day 5 or early termination)|The safety analysis population included All participants who received at least 1 dose of BeneFIX.|||Participants|||Number
2596212|NCT02213250|Secondary|Number of Participants With Abnormal Clinical Laboratory Measurements (Without Regard to Baseline Abnormality)|Clinical laboratory analysis tests included hematology, serium chemistry, prothrombin time and urianalysis. Numbers of subjects with laboratory test abnormalities without regard to baseline abnormality were reported.|Baseline up to 96 hours post-dose (Day 5 or early termination)|The safety analysis population included All participants who received at least 1 dose of BeneFIX.|||Participants|||Number
2596213|NCT02213250|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE), and Withdrawals Due to Adverse Events (AE)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAE is defined as newly occurring or worsening after first dose.|From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.|The safety analysis set was defined as all participants who received at least 1 dose of BeneFIX.|||Particpants|||Number
2596231|NCT02212977|Primary|Number of Participants With Complication of Infection|To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.|3 months||||participants|||Number
2596214|NCT02213250|Primary|Incremental Recovery|Incremental recovery: Increase in circulating increase in FIX activity for every IU of BeneFIX administered per kg of body weight.|Pre-dose, 0.25, 0.5 and 1 hour post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||(IU/dL)/(IU/Kg)||Geometric Coefficient of Variation|Geometric Mean
2596215|NCT02213250|Primary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||mL/hr/kg||Geometric Coefficient of Variation|Geometric Mean
2596216|NCT02213250|Primary|Plasma Decay Half-Life (t½)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||hours||Standard Deviation|Mean
2596217|NCT02213250|Primary|Mean Residence Time (MRT)|AUMCinf/AUCinf, where AUMCinf is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||hours||Geometric Coefficient of Variation|Geometric Mean
2596218|NCT02213250|Primary|Terminal Phase Rate Constant (Kel)|Linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||1/hr||Geometric Coefficient of Variation|Geometric Mean
2596219|NCT02213250|Primary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.|Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||milliliter/kilogram (mL/kg)||Geometric Coefficient of Variation|Geometric Mean
2596220|NCT02213250|Primary|Time to Reach Cmax (Tmax)||Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||hours||Full Range|Median
2596221|NCT02213250|Primary|Area Under the Concentration Time Curve From Time 0 to Infinity (AUCinf)||Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||IU*hr/ml||Geometric Coefficient of Variation|Geometric Mean
2596222|NCT02213250|Primary|Area Under the Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)||Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||IU*hour/milliliter (IU*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2596223|NCT02213250|Primary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose|The pharmacokinetics (PK) parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.|||IU/milliliter (IU/mL)||Geometric Coefficient of Variation|Geometric Mean
2596224|NCT02213198|Primary|Engagement in Treatment|Whether patient kept appointment post TCC|6 months|All patients for whom survey (call data) were available post TCC discharge|||Participants|||Count of Participants
2596225|NCT02213198|Primary|Subjective Quality of Life|The Quality of Life Interview (QOLI; 91) is a 45-minute structured interview that assesses quality of life in the domains of family, social relations, leisure activities, finances, legal/safety issues, work/school, and health. It is one of the most psychometrically sound QoL instruments for use in mental illness. The subjective scale assesses quality of life from the perspective of the patient. Subjective QOL = Mean of items 1,3,8,9,11,13,16,18,20,21 . Scores range from 1-7. Higher scores indicate better quality of life|baseline, 3 months and 6 months|All patients with baseline and at least one follow up on QOL|||units on a scale||Standard Deviation|Mean
2596226|NCT02213094|Primary|Number of Participants With Adverse Events|Specific adverse events were Maternal liver toxicity, defined as > 3x ULN of ALT(Alanine amniotransferase) or AST (Aspartate amniotransferase), maternal report of side effects, and fetal adverse effects.|Within 48 hours of dosing||||participants|||Number
2596227|NCT02213055|Primary|Number of Participants Free of Live Head Lice and Free of Viable Eggs|"A determination of head lice effectiveness, measured by number of subjects free of live lice and by number of subjects free of viable eggs, was calculated using two week post-treatment data as the primary study outcome. Measurements were calculated at Day 1 (day after first treatment) and Day 14.~At diagnosis, 55 subjects had viable eggs with three subjects meeting enrollment criteria for three or more live lice."|Day after first treatment and Day 14 of study|There were 58 evaluable subjects in the experimental (LiceMD) arm of the study.|||Participants|||Number
2596228|NCT02212977|Secondary|Closure Materials Cost|Per unit cost for suture and octylcyanoacrylate|Baseline||||dollars|||Number
2596229|NCT02212977|Secondary|Closure Time|To compare closure time and associated costs between these two methods of skin closure.|Baseline||||minutes||Standard Deviation|Mean
2606898|NCT02096029|Primary|Percentage of Participants With 7-Day Self-Reported Point Prevalence Abstinence||From study enrollment through end of six-month follow up||||percentage of participants|||Number
2596234|NCT02212678|Primary|Glutathione (GSH) Brain Levels|GSH levels in brain of all subjects at baseline and post-NAC (n-acetylcysteine) dosing as measured by magnetic resonance spectroscopy (MRS)|pre-dose and after approximately 28 days of treatment||||mM||Standard Deviation|Mean
2596235|NCT02212457|Secondary|Number of Participants Reporting Any Serious AE (SAE), Medically Attended AEs (MAAEs), AEs Leading to Premature Withdrawal|The number of participants reporting any SAE, possibly or probably related SAE(s), medically-attended AEs, AEs leading to premature withdrawal, AEs leading to death, AEs leading to hospitalization and AEs leading to dose reduction, interruption and delay in study vaccination during the entire study period is reported.|During the entire study period (Month 0 to Month 13)|Analysis was done on all subjects in the Unsolicited Safety Set-all screened subjects who provided informed consent & provided demographic &/or other baseline screening measurements, regardless of the subject’s randomization & vaccination status, received a subject ID, received a study vaccination and have post-vaccination unsolicited AE records.|||Participants|||Count of Participants
2596236|NCT02212457|Secondary|Number of Participants Reporting Any Solicited Local or Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity From Day 1 to Day 7.|Number of participants reporting any solicited local or systemic AEs and other indicators of reactogenicity from Day 1 (6 hours) to Day 7 after any meningococcal vaccination is reported.|At Day 1 (6 hours) to Day 7 after vaccination|Analysis was done on all subjects in the Solicited Safety Set-all screened subjects who provided informed consent & provided demographic &/ other baseline screening measurements,regardless of the subject’s randomization & vaccination status in the trial,received a subject ID,provided post-vaccination reactogenicity data & received study vaccination|||Participants|||Count of Participants
2596237|NCT02212457|Secondary|Number of Participants Reporting Unsolicited AEs From Day 1 to Day 30 After Any Vaccination.|The number of participants reporting unsolicited AEs and possibly or probably related unsolicited AEs were assessed.|Day 1 through Day 30 after any vaccination|Analysis was done on subjects in the Unsolicited Safety Set -all screened subjects who provided informed consent & provided demographic &/or other baseline screening measurements, regardless of the subject’s randomization & vaccination status, received a subject ID, received a study vaccination & have either post-vaccination reactogenicity records.|||Participants|||Count of Participants
2596238|NCT02212457|Secondary|Number of Participants Reporting Any Unsolicited AEs Within 30 Minutes After Vaccination.|An unsolicited adverse event is an adverse event that was not solicited and that was spontaneously communicated by a participant and/or parent/legal guardian who has signed the informed consent. Number of participants reporting any unsolicited AE within 30 minutes after each vaccination.|Within 30 minutes after vaccination|Analysis was done on subjects in the Unsolicited Safety Set-all screened subjects who provided informed consent & demographic &/or other baseline screening measurements, regardless of the subject's randomization & vaccination status, received a subject ID, received a study vaccination & have either post-vaccination reactogenicity data or records.|||Participants|||Count of Participants
2596239|NCT02212457|Secondary|Number of Participants Reporting Any Solicited Local or Systemic AEs and Other Indicators of Reactogenicity Within 30 Minutes After Vaccination.|Number of participants reporting any solicited local or systemic AEs and other indicators of reactogenicity within 30 minutes after each vaccination. Assessed solicited symptoms were Pain, erythema and induration. Assessed solicited systemic symptoms were Fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills, and fever (body temperature ≥38.0°C).|Within 30 minutes after vaccination|Analysis was done on subjects in Solicited Safety Set - all screened subjects who provided informed consent & provided demographic &/or other baseline screening measurements, regardless of the subject’s randomization & vaccination status in the trial, received a subject ID,provided post-vaccination reactogenicity data & received a study vaccination|||Participants|||Count of Participants
2596240|NCT02212457|Secondary|The Area Under the Curve (AUC) for Percentage of Subjects With hSBA Titers ≥LLQ for All Serogroups and Strains.|The area under the curve for percentage of subjects with hSBA titers ≥ LLQ for all serogroups (A, C, W and Y) and for all serogroup B test strains (M14459, 96217, NZ98/254 and M07-0241084) was summarized overall (from Month 0 to Month 13) and by period (from Month 0 to Month 2, Month 2 to Month 3, Month 3 to Month 7 and Month 7 to Month 13) by vaccine groups. It was computed as the sum of the trapezoidal areas and the time unit used was the month. AUC 0_13 = (r0+r2)(2-0)/2 + (r2+r3)(3-2)/2 + (r3+r7)(7-3)/2 + (r7+r13)(13-7)/2 with ri = percentages of subjects with both hSBA titers >= LLQ against N. meningitis for all serogroups A, C, W and Y and for all serogroup B test strains at Month 1.|From Month 0 to Month 13|Analysis was done on the FAS Month 13 Over Time. All subjects in All Enrolled Set who received a study meningococcal vaccination & provided evaluable serum samples at one month after the last meningococcal vaccination whose result is available for at least one A,C,W,or Y serogroup or serogroup B test strain.|||Percentage of subjects|||Number
2596241|NCT02212457|Secondary|Percentages of Subjects With Two-, Three- and Four-fold Titer Rise Against Serogroups A, C, W and Y and Serogroup B Test Strains for All Schedules.|The kinetic of immune response (at Months 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with two-, three- and four-fold titer rise against serogroups A, C, W and Y and serogroup B test strains was assessed. The two/three/four fold titer rise is defined as: a) for subjects with prevaccination hSBA titers ≤ LLQ, a postvaccination hSBA ≥ 2/3/4 LLQ; b) for subjects with a prevaccination hSBA titers ≥ LLQ, an increase of at least 2/3/4 times of the prevaccination hSBA titer.|At Month 2, Month 3, Month 7 and Month 13|Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for atleast one serogroup or serogroup B test strain.|||Percentages of subjects||95% Confidence Interval|Number
2596242|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against Y Human Serogroup for All Schedules.|The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against Y human serogroup was assessed.|At Month 0, Month 2, Month 3, Month 7 and Month 13.|Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for at least one serogroup or serogroup B test strain.|||Percentages of subjects||95% Confidence Interval|Number
2596243|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against W Human Serogroup for All Schedules.|The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against W human serogroup was assessed.|At Month 0, Month 2, Month 3, Month 7 and Month 13.|Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for atleast one serogroup or serogroup B test strain.|||Percentages of subjects||95% Confidence Interval|Number
2596244|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against C Human Serogroup for All Schedules.|The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against C human serogroup was assessed.|At Month 0, Month 2, Month 3, Month 7 and Month 13.|Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for atleast one serogroup or serogroup B test strain.|||Percentages of subjects||95% Confidence Interval|Number
2596245|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against A Human Serogroup for All Schedules.|The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against A human serogroup was assessed.|At Month 0, Month 2, Month 3, Month 7 and Month 13.|Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for atleast one serogroup or serogroup B test strain.|||Percentages of subjects||95% Confidence Interval|Number
2596246|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against 96217 B Strain for All Schedules.|The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against 96217 B strain was assessed.|At Month 0, Month 2, Month 3, Month 7 and Month 13.|Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for atleast one serogroup or serogroup B test strain.|||Percentages of subjects||95% Confidence Interval|Number
2596247|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M07-0241084 B Strain for All Schedules.|The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against M07-0241084 B strain was assessed.|At Month 0, Month 2, Month 3, Month 7 and Month 13.|Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for atleast one serogroup or serogroup B test strain.|||Percentages of subjects||95% Confidence Interval|Number
2596248|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against M14459 B Strain for All Schedules.|The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against M14459 B strain was assessed.|At Month 0, Month 2, Month 3, Month 7 and Month 13.|Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for atleast one serogroup or serogroup B test strain.|||Percentages of subjects||95% Confidence Interval|Number
2596249|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 Against NZ98/254 B Strain for All Schedules.|The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the percentages of subjects with hSBA titers ≥LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 against NZ98/254 B strain was assessed.|At Month 0, Month 2, Month 3, Month 7 and Month 13.|Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for atleast one serogroup or serogroup B test strain.|||Percentages of subjects||95% Confidence Interval|Number
2596250|NCT02212457|Secondary|hSBA GMTs Against Serogroups A, C, W and Y and Serogroup B Test Strains at All the Relevant Time Points for All Schedules.|The kinetic of immune response (at Months 0, 2, 3, 7 and 13) following different vaccination schedules as measured by the adjusted hSBA GMTs against serogroups A,C, W and Y and serogroup B test strains was assessed.|At Month 0, Month 2, Month 3, Month 7 and Month 13|Analysis was done on the FAS Month 13 which included all screened subjects who received a study vaccination & provided evaluable serum samples at month 0 and atleast from month 2 to 13 and provided results for atleast one serogroup or serogroup B test strain.|||Titers||95% Confidence Interval|Geometric Mean
2596251|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥ LLQ Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0_11 Month Schedule.|The immunogenicity of MenABCWY vaccine, administered according to 0, 2 month schedule, was compared with those, administered according to 0, 1 month, 0, 6 month and 0, 11 month schedules, as measured by the percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains at 1 month after the second meningococcal vaccination.|At 1 month after second vaccination (Month 2 for ABCWY_0_1 Group, Month 3 for ABCWY_0_2 Group , Month 7 for ABCWY_0_6 Group and Month 13 for ABCWY_0_11 Group)|Analysis was done on the FAS- 1 month after last meningococcal vaccination, which included all screened subjects who provided informed consent, received a study vaccination & provided evaluable serum samples at 1 month after last vaccination whose results were available for atleast 1 serogroup or B strain|||Percentages of subjects||95% Confidence Interval|Number
2596890|NCT02203630|Secondary|Mean Sequential Organ Failure Assessment (SOFA) Score|Predicts ICU mortality based on lab results and clinical data. Range is 0-24 with higher numbers indicating a higher risk of mortality|Up to 28 days|data was not collected||||||
2596252|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule.|The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 month schedule, was compared with those, administered according to 0, 6 month schedule, as measured by the percentages of subjects with hSBA titers ≥ LLQ against serogroups A, C, W and Y and serogroup B test strains at 1 month after the last meningococcal vaccination.|At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 7)|Analysis was done on the FAS- 1 month after last meningococcal vaccination, which included all screened subjects who provided informed consent, received a study vaccination & provided evaluable serum samples at 1 month after last vaccination whose results were available for atleast 1 serogroup or B strain|||Percentages of subjects||95% Confidence Interval|Number
2596253|NCT02212457|Secondary|hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_6 Month Schedule.|The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 months schedule was compared with those administered according to 0, 6 months schedule, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains at 1 month after the last meningococcal vaccination.|At 1 month after last vaccination (Month 7)|Analysis was done on the FAS- 1 month after last meningococcal vaccination, which included all screened subjects who provided informed consent, received a study vaccination & provided evaluable serum samples at 1 month after last vaccination whose results were available for atleast 1 serogroup or B strains|||Titers||95% Confidence Interval|Geometric Mean
2596254|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥ Lower Limit of Quantitation (LLQ) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule.|A sufficient immune response following Bexsero vaccine, administered according to 0, 2 month schedule, as measured by the percentage of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against N. meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination, was to be demonstrated. Criterion: the immune response was to be considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titers ≥ LLQ was greater than 75% for each of the four serogroup B test strains. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab.|At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)|Analysis was done on Full Analysis Set(FAS)- 1 month post meningococcal vaccination. Subjects in All Enrolled Set who received a study meningococcal vaccination & provided evaluable serum samples at pre- & at 1 month post last meningococcal vaccination whose result is available for at least one A,C,W or Y serogroup or serogroup B test strain.|||Percentages of subjects||95% Confidence Interval|Number
2596255|NCT02212457|Secondary|hSBA GMTs Against Each of N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_1 Month, 0_2 Month, 0_6 Month and 0, 11 Month Schedule.|The immunogenicity of MenABCWY vaccine, administered according to 0, 2 months schedule, was compared with those, administered according to 0, 1 month, 0, 6 month and 0, 11 month schedules as measured by hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains at 1 month after the second meningococcal vaccination.|At 1 Month after the last vaccination (Month 2 for ABCWY_0_1 Group, Month 3 for ABCWY_0_2 Group, Month 7 for ABCWY_0_6 Group and Month 13 for ABCWY_0_11 Group)|Analysis was done on the FAS- 1 month after last meningococcal vaccination, which included all screened subjects who provided informed consent, received a study vaccination & provided evaluable serum samples at 1 month after last vaccination whose results were available for atleast 1 serogroup or B strain|||Titers||95% Confidence Interval|Geometric Mean
2596256|NCT02212457|Secondary|Percentages of Subjects With hSBA Titers ≥LLQ Against N. Meningitidis Serogroups A, C, W and y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule.|The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 month schedule, was compared with those, administered according to 0, 2 month schedule, as measured by the percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination.|At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3 for ABCWY_ 0_2 Group and Month 7 for ABCWY_0_2_6 Group)|Analysis was done on the FAS-1 month after the last meningococcal vaccination.All subjects in All Enrolled Set who received a study meningococcal vaccination & provided evaluable serum samples at pre- & at one month after the last meningococcal vaccination whose result is available for at least one A,C,W,or Y serogroup or serogroup B test strain.|||Percentages of subjects||95% Confidence Interval|Number
2596257|NCT02212457|Secondary|hSBA GMTs Against N. Meningitidis Serogroups A, C, W and Y and Serogroup B Test Strains When Administered According to 0_2_6 Month and 0_2 Month Schedule.|The immunogenicity of MenABCWY vaccine, administered according to 0, 2, 6 months schedule was compared with those administered according to 0, 2 months schedule, as measured by hSBA GMTs against N. meningitidis serogroup B test strains and serogroups A,C, W and Y at 1 month after the last meningococcal vaccination. The B test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. This outcome measure was evaluated in the ABCWY_ 0_2 and ABCWY_0_2_6 Groups. 1 month post last meningococcal vaccination corresponds to Month 3 for ABCWY_0_2 Group and Month 7 for ABCWY_0_2_6 Group.|At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3 for ABCWY_ 0_2 Group and Month 7 for ABCWY_0_2_6 Group)|Analysis was done on the FAS-1 month after the last meningococcal vaccination.All subjects in All Enrolled Set who received a study meningococcal vaccination & provided evaluable serum samples at pre- & at one month after the last meningococcal vaccination whose result is available for at least one A,C,W,or Y serogroup or serogroup B test strain.|||Titers||95% Confidence Interval|Geometric Mean
2596287|NCT02211534|Secondary|Beck Depression Inventory (BDI)|"Responders: Defined as subjects with a 5-point decrease in Beck Depression Inventory (BDI) score.~BDI is a validated self-reported assessment of current symptoms of depressive disorders, with total scores ranging from 0 to 63. The BDI scale consists of 21 groups of statements with each score/response ranging from 0 to 3. Higher scores represent greater depression. The BDI was conducted at baseline prior to study device treatments and again at Day 61."|Responders at Day 75 (compared to baseline)|Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 75 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 75 assessment. Subjects without a Day 75 assessment were left out of the analysis.|||Participants|||Count of Participants
2596258|NCT02212457|Primary|Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup B Test Strains When Administered According to 0_2 Month Schedule.|The non-inferiority of the Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant (MenABCWY) vaccine to Meningococcal (group B) multicomponent recombinant adsorbed (Bexsero) vaccine, administered according to 0, 2 month schedule, as measured by hSBA GMTs against N.meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination, is reported. The test strains assessed were Meningitis B NZ98/254 Ab, Meningitis B M14459 Ab, Meningitis B M07-0241084 Ab and Meningitis B 96217 Ab. This outcome measure was evaluated in the rMenB_0_2 and ABCWY_ 0_2 Groups.|At baseline (Month 0) and 1 month after the last meningococcal vaccination (Month 3)|Analysis was done on Per Protocol Set (PPS)–Month 3, which included all screened subjects who received a study vaccination, provided evaluable serum samples at pre- & post-vaccination, with results available for at least 1 serogroup B test strain & who was not excluded due to protocol deviations/other reasons defined before unblinding/analysis|||Titers||95% Confidence Interval|Geometric Mean
2596259|NCT02212301|Primary|Time Controlled Visual Acuity|"The Time Controlled Visual Acuity test is a proprietary test part of MG Vision Advanced Visual Performance Assessment. The test for distance vision is carried out at 4m under high contrast and dim luminance. The test is presented on a fast response 17 LCD screen (1280 by 1064). The test for intermediate vision is carried out at 64cm under high contrast dim luminance. The test was presented on a fast response 13.3 LCD screen (3200 by 1800). Visual acuity will be measured in a controlled environment using logMAR units."|8 hours post insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted for each lens at both near (40cm) and far distance (4m).|||LogMAR||Standard Deviation|Mean
2596260|NCT02212301|Primary|Tear Film Kinetics|The non-invasive tear film break-up-time (NIBUT) is the time elapsed (in seconds) between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with the wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability and the on eye wettability of contact lenses.|8 hour post insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subjects was excluded from the analysis population due to a major protocol deviation.|||Seconds||Standard Deviation|Mean
2596261|NCT02212197|Secondary|Mean Prostate Specific Antigen (PSA) Concentration|The PD effects of leuprolide were assessed by measuring serum PSA concentrations during the trial. The following PD variable was analyzed: PSA (ng/mL) response to IMP. Blood samples for analyses of plasma PSA concentrations were collected at Screening and on Days 0 to 126.|Days 0-126|The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.|||ng/mL||Inter-Quartile Range|Median
2596262|NCT02212197|Secondary|Profiles of Testesterone Concentration (ng/dL) Following Injections of the Investigational Medicinal Product (IMP)|The PD effects of leuprolide were assessed by measuring serum testosterone concentrations during the trial. The following PD variable was analyzed: The profiles of testosterone concentration (ng/dL) following injections of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.|Days 0-126|The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.|||ng/dL||Inter-Quartile Range|Median
2596263|NCT02212197|Secondary|Time (Days) to Testosterone Recovery After Dose 3|The pharmacodynamic (PD) effects of leuprolide were assessed by measuring serum testosterone during the trial. Time to testosterone recovery after last dose of the IMP. Blood samples for analyses of serum testosterone concentrations were collected at Screening and on Days 0 to 126.|Days 56-126|The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.|||days||Standard Deviation|Mean
2596264|NCT02212197|Primary|Area Under the Serum Concentration-time Curve (AUC) Over the Dosing Interval (AUCtau) for Dose 1 and Dose 3|Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, AUCtau was derived for Doses 1 and 3 of the IMP.|Days 0-28 and Days 56-84 (0-672 hours after Doses 1 and 3)|The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2596265|NCT02212197|Primary|Apparent Terminal Half-life (t½) for Dose 1 and Dose 3|Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, t1/2 was derived for Doses 1 and 3 of the IMP.|Days 0-28 and Days 56-84|The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.|||hour||Standard Deviation|Mean
2596266|NCT02212197|Primary|Observed Maximum Serum Leuprolide Concentration (Cmax) for Dose 1 and Dose 3|Blood samples for analysis of serum leuprolide concentrations were collected at pre-determined time points throughout the trial (with full PK profiles after Dose 1 and Dose 3). The PK parameter, Cmax was derived for Doses 1 and 3 of the investigational medicinal product (IMP).|84 days|The Per-Protocol Set (PPS) consisted of all randomized participants in the safety population who had a complete PK profile. In the CAM2032 3.75 mg group 15 of the 19 randomized participants were included in the PPS.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2596267|NCT02212106|Secondary|The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine.|The number of subjects experiencing at least one SAE.|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.|||Number of subjects|||Number
2596363|NCT02209766|Primary|Number of Patients With Treatment-emergent Adverse Events (TEAEs), by Treatment (Safety Analysis Set)|Number of patients with treatment-emergent adverse events (TEAEs), by treatment (Safety Analysis Set)|from first dosing (Day1) until follow-up (Day25)||||subjects|||Number
2596268|NCT02212106|Secondary|The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.|The overall frequency and intensity of unsolicited Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall.|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.|||Percentage of subjects|||Number
2596269|NCT02212106|Secondary|The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.|The overall frequency and intensity of solicited systemic Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.|||Percentage of subjects|||Number
2596270|NCT02212106|Secondary|The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.|The overall frequency and intensity of solicited local Adverse Events (AEs) occurring during the 7 days after each administration of bioCSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.|||Percentage of subjects|||Number
2596271|NCT02212106|Secondary|The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.|Percentage of subjects with a related fever event (overall) by study vaccine group based on the number of subjects contributing any follow up safety information for at least one data value of an individual sign/symptom. Excludes subjects with missing intensity information for the whole 7 days. Mild fever: ≥ 100.4 to < 101.3º F (≥ 38.0 to < 38.5º C). Moderate fever: ≥ 101.3 to < 102.2º F (≥ 38.5 to < 39.0º C). Severe fever: ≥ 102.2º F (≥ 39.0º C).|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.|||Percentage of subjects|||Number
2596272|NCT02212106|Secondary|The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.|The overall percentage of subjects reporting at least one fever event after administration of the comparator influenza virus vaccine. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C).|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination follow-up safety data available.|||Percentage of subjects|||Number
2596273|NCT02212106|Primary|The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.|The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)|7 days after each administration of vaccine.|All randomized subjects who received at least one scheduled vaccination and had post-vaccination follow-up safety data available.|||Percentage of subjects|||Number
2596274|NCT02212028|Secondary|Platelet Reactivity Index (PRI)|The secondary end-point of the study is the comparison in platelet reactivity expressed as PRI determined by whole blood vasodilator-stimulated phosphoprotein (VASP) between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration|2 hrs|The primary population was defined as patients who received the randomized treatment and had a valid primary end point value (PRU at 2 hours) and was considered for analysis of all endpoints.|||PRI||95% Confidence Interval|Least Squares Mean
2596275|NCT02212028|Primary|P2Y12 Reaction Units (PRU)|The primary end-point of the study is the comparison in platelet reactivity expressed as PRU determined by VerifyNow P2Y12 between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration|2 hrs|The primary population was defined as patients who received the randomized treatment and had a valid primary end point value (PRU at 2 hours) and was considered for analysis of all endpoints.|||PRU||95% Confidence Interval|Least Squares Mean
2596276|NCT02211638|Primary|Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Calcium Channel Blocker (CCB)-Containing ARB Combination Drug Therapy at Week 14|Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at last dose of ARB combination drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to calcium channel blocker (CCB)-containing ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care.|Baseline and Last dose of ARB Combination Drug (up to Month 6)|Safety analysis set was defined as all participants who were enrolled and completed the study. Analysis population was participants in safety analysis set who switched to calcium channel blocker (CCB)-containing ARB combination drug therapy from candesartan therapy at Week 14 and were assessed with this outcome measure.|||mmHg||Standard Deviation|Mean
2596364|NCT02209766|Secondary|Tmax in Plasma Baseline-adjusted Total DHA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||h||Full Range|Median
2596277|NCT02211638|Primary|Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to Diuretic-containing ARB Combination Drug Therapy at Week 14|Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at last dose of diuretic-containing ARB combination drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to diuretic-containing ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care.|Baseline and Last dose of ARB Combination Drug (up to Month 6)|Safety analysis set was defined as all participants who were enrolled and completed the study. Analysis population was participants in safety analysis set who switched to diuretic-containing ARB combination drug therapy from candesartan therapy at Week 14 and were assessed with this outcome measure.|||mmHg||Standard Deviation|Mean
2596278|NCT02211638|Secondary|Number of Participants Who Experience at Least One Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|Up to Month 3|Safety analysis set was defined as all participants who were enrolled and completed the study.|||Participants|||Count of Participants
2596279|NCT02211638|Primary|Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Switched to ARB Combination Drug Therapy at Week 14|Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan and last dose of ARB Combination Drug (up to Month 6) relative to baseline were reported. The data was for only participants who switched to ARB combination drug therapy from candesartan therapy at Week 14 as part of routine medical care.|Baseline, Month 3, Last dose of Candesartan, and Last dose of ARB Combination Drug (up to Month 6)|Safety analysis set was defined as all participants who were enrolled and completed the study. Analysis population was participants in safety analysis set who switched to ARB combination drug therapy from candesartan therapy at Week 14 and were assessed with this outcome measure. Here 'n' is number of participants analyzed at the given timepoint.|||mmHg||Standard Deviation|Mean
2596280|NCT02211638|Primary|Changes in Clinic Blood Pressure in the Sitting Position for Participants Who Continued Candesartan Therapy at Week 14|Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan (up to Month 6) relative to baseline in only participants who continued candesartan therapy at Week 14 were reported.|Baseline, Month 3 and Last dose of Candesartan (up to Month 6)|Safety analysis set was defined as all participants who were enrolled and completed the study. Analysis population was participants in safety analysis set who continued candesartan therapy at Week 14 and were assessed with this outcome measure. Here 'n' is number of participants analyzed at the given timepoint.|||mmHg||Standard Deviation|Mean
2596281|NCT02211638|Primary|Changes in Clinic Blood Pressure in the Sitting Position|Changes in clinic blood pressure (systolic blood pressure -SBP and diastolic blood pressure -DBP) in the sitting position measured at Month 3, last dose of candesartan (up to Month 6) relative to baseline were reported.|Baseline, Month 3 and Last dose of Candesartan (up to Month 6)|Safety analysis set was defined as all participants who were enrolled and completed the study. Analysis population was all participants in safety analysis set who were assessed with this outcome measure. Here 'n' is number of participants analyzed at the given timepoint.|||mmHg||Standard Deviation|Mean
2596282|NCT02211534|Secondary|Change in Pain Intensity - Average Pain Intensity|Pain Intensity (PI): a validated 11-point Numeric Pain Rating Scale (NPRS) with scores (0-10) collected as patient-reported outcomes on an electronic diary (ePRO).|At Days 75, 90, 150 and 240, as compared to Baseline|Data were not collected.||||||
2596283|NCT02211534|Secondary|Change From Baseline in Peripheral Edema - Maximal Circumference of Calf (cm)|The maximal circumference of the calf and circumference of the thigh at 10 cm and 15 cm cranial to the superior pole of the patella of the index knee will be measured using a tape measure.|Day 75|Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 75 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 75 assessment. Subjects without a Day 75 assessment were left out of the analysis.|||cm||Standard Deviation|Mean
2596284|NCT02211534|Secondary|Change From Baseline in Range of Motion (ROM)|The degree of passive (movement of the knee with the aid of study personnel) and active (subject moving the knee) knee flexion and extension tolerated by the subject will be recorded. ROM will be assessed in the sitting position using a goniometer.|Days 0 (Baseline) and Day 75||||degrees of motion||Standard Deviation|Mean
2596285|NCT02211534|Secondary|Analgesic Consumption|Consumption of opioid analgesics in the preceding 24 hours will be self-reported by the subject in the ePRO diary on a daily basis during the 10-day run-in period, treatment period and through Day 75. The results below display the difference in opioid analgesic consumption from baseline to Day 56-60. Subject recorded the number of tablets consumed.|Day 56 to Day 60 (compared to baseline)|Number of Participants Analyzed differs from numbers above due to the number of subjects reporting opioid analgesic consumption in their ePRO diary.|||Number of tablets taken||Standard Deviation|Mean
2596286|NCT02211534|Secondary|Patient Global Impression of Change (PGIC)|"Responder Analysis at Day 75 (patents stating they are Improved to Much Improved) using the Patient Global Impression of Change (PGIC). PGIC is a 7-point validated categorical scale of overall change in status since initiation of treatment with the study device. PGIC allows subjects to integrate into one overall evaluation the different aspects of their response to treatment, including pain reduction, improvement in functioning and side effects. Subjects select one of the following response at the end of treatment: Very Much Worse, Much Worse, Minimally Worse, No Change, Minimally Improved, Improved, or Much Improved."|Day 75|Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 75 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 75 assessment. Subjects without a Day 75 assessment were left out of the analysis.|||Participants|||Count of Participants
2596365|NCT02209766|Secondary|Cmax in Plasma Baseline-adjusted Total DHA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2596366|NCT02209766|Secondary|Tmax in Plasma Baseline-adjusted Total EPA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||h||Full Range|Median
2596288|NCT02211534|Secondary|Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS)|Knee Injury and Osteoarthritis Outcome Score (KOOS): a validated knee-specific instrument that measures the short-term and long-term symptoms and function associated with knee injury. KOOS consists of 5 categories: pain, other symptoms, function in daily living, function in sport and recreation, and knee related quality of life. Patients are asked to answer questions relating to these categories and respond with Never/None/Not at all, Rarely/Monthly/Mild, Sometimes/Moderate/Weekly, Often/Severe/Daily or Always/Extreme/Totally/Constantly. Each response gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The mean change in score from baseline to Day 75 is displayed below.|Mean change from Day 0 to Day 75|Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 75 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 75 assessment. Subjects without a Day 75 assessment were left out of the analysis.|||units on a scale||Standard Deviation|Mean
2596289|NCT02211534|Primary|Change in Pain Intensity|"Percent change from Baseline in Pain Intensity (PI): a validated 11-point Numeric Pain Rating Scale (NPRS) with scores (0-10) collected as patient-reported outcomes on an electronic diary (ePRO). A score of 0 represents 'No Pain' while a score of 10 represents Worst Pain Imaginable."|Assessed at Day 60 as compared to Baseline|Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 60 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 60 assessment. Subjects without a Day 60 assessment were left out of the analysis.|||Units on a scale||Standard Deviation|Mean
2596290|NCT02211313|Primary|Change From Baseline in Pain on the 10-point Analog Pain Scale at Day 7 Post Stent Removal.|The 10-point scale ranges from 0 (zero) for no pain (minimum) to 10 for the worst possible pain (maximum). The unit of measure is 1 point on the 10-point scale.|Baseline, day 7 post stent removal||||Scores on a scale 0-10 (Numeric)||Standard Deviation|Mean
2596291|NCT02211261|Secondary|Observed Accumulation Ratio Based on Cmax (Rac,Cmax) of PF-06293620 (MAD Cohorts)|Observed accumulation ratio based on Cmax (Rac,Cmax) of PF-06293620 was calculated as Cmax(Day57)/Cmax(Day1).|Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2596292|NCT02211261|Secondary|Observed Accumulation Ratio Based on AUC (Rac) of PF-06293620 (MAD Cohorts)|Observed accumulation ratio based on AUC (Rac) of PF-06293620 was calculated as AUCtau(Day57)/AUCtau(Day1).|Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2596293|NCT02211261|Secondary|Terminal Elimination Half-life (Thalf) of PF-06293620 (MAD Cohorts) After Day 57 Administration|Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.|Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||days||Standard Deviation|Mean
2596294|NCT02211261|Secondary|Apparent Volume of Distribution (Vz/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration|Apparent volume of distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCtau/kel), where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours); and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.|Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||liters||Geometric Coefficient of Variation|Geometric Mean
2596295|NCT02211261|Secondary|Apparent Clearance (CL/F) of PF-06293620 (MAD Cohorts) After Day 57 Administration|Apparent clearance (CL/F) of PF-06293620 was calculated as dose/AUCtau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).|Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||mL/hr||Geometric Coefficient of Variation|Geometric Mean
2596296|NCT02211261|Secondary|Time for Maximum Serum Concentration (Tmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration|Time for maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.|Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||hours||Full Range|Median
2596297|NCT02211261|Secondary|Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-06293620 (MAD Cohorts) After Day 57 Administration||Pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169|The pharmacokinetic (PK) concentration population included all enrolled participants treated who had at least 1 measurable (greater than lower limit of quantification) concentration value.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2596319|NCT02210208|Primary|Part A: Number of Participants With Healing|Part A: Adequate take of skin graft (defined as at least 95% adherent and healed as assessed by clinical investigator).|14 days|ITT population. During the surgery, the Phycisian decided that one patient should not receive any skin graft. Therefore there are only 24 patients in Part A and 18 patients in Part B. At Baseline there were 25 ITT patients evaluated for Part A and 19 patients for Part B.|||Participants|||Count of Participants
2596891|NCT02203630|Secondary|Number of Days Hemodialysis Needed||Up to 28 days|only participants that required dialysis|||days|||Number
2596298|NCT02211261|Secondary|Average Concentration (Cav) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration|Average Concentration (Cav) of PF-06293620 was calculated as AUCtau/tau, where AUCtau was area under the concentration-time profile from time 0 to time tau, and tau was the dosing interval, 4 weeks (672 hours).|Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169|The PK concentration population included all enrolled participants treated who had at least 1 measurable concentration value.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2596299|NCT02211261|Secondary|Maximum Serum Concentration (Cmax) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration||Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169|The PK concentration population included all enrolled participants treated who had at least 1 measurable concentration value.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2596300|NCT02211261|Secondary|Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06293620 (MAD Cohorts) After Day 1 and Day 57 Administration|Tau refers to the dosing interval, which was 4 weeks (672 hours). Area under the concentration-time profile from time 0 to time tau (AUCtau) was determined using linear/log trapezoidal method.|Pre-dose, 1 and 4 hours post-dose on Day 1; Days 2, 3, 7, 8, 15, 27, 28; pre-dose, 1 and 4 hours post-dose on Day 29; Days 36, 43; pre-dose, 1 and 4 hours post-dose on Day 57; Days 58, 59, 63, 64, 71, 78, 84, 85, 99, 113, 141, 169|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2596301|NCT02211261|Secondary|Terminal Elimination Half-life (Thalf) of PF-06293620 (SAD Cohorts)|Terminal elimination half-life (Thalf) of PF-06293620 was calculated as ln(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.|Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||days||Standard Deviation|Mean
2596302|NCT02211261|Secondary|Apparent Volume of Distribution (Vz/F) of PF-06293620 (SAD Cohorts)|Apparent Volume of Distribution (Vz/F) of PF-06293620 was calculated as dose/(AUCinf*kel), where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time, kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. This outcome measure only applies to SC arms.|Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||liters||Geometric Coefficient of Variation|Geometric Mean
2596303|NCT02211261|Secondary|Steady-state Volume of Distribution (Vss) of PF-06293620 (SAD Cohorts)|Steady-state volume of distribution (Vss) of PF-06293620 was calculated as CL*MRT, where MRT was the mean residence time calculated as (AUMCinf/AUCinf - infusion duration/2), AUMCinf was area under the moment curve from time 0 extrapolated to infinity; CL was the clearance. This outcome measure only applies to IV arms.|Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||liters||Geometric Coefficient of Variation|Geometric Mean
2596304|NCT02211261|Secondary|Time for Maximum Serum Concentration (Tmax) of PF-06293620 (SAD Cohorts)|Time for Maximum serum concentration (Tmax) of PF-06293620 was observed directly from data as time of first occurrence.|Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||hours||Full Range|Median
2596305|NCT02211261|Secondary|Maximum Serum Concentration (Cmax) of PF-06293620 (SAD Cohorts)|Maximum serum concentration (Cmax) of PF-06293620 was observed directly from data.|Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85|The pharmacokinetic (PK) concentration population included all enrolled participants treated who had at least 1 measurable (greater than lower limit of quantification) concentration value.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2596306|NCT02211261|Secondary|Apparent Clearance (CL/F) of PF-06293620 (SAD Cohorts)|Apparent Clearance (CL/F) of PF-06293620 was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to SC arms.|Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||mL/hr||Geometric Coefficient of Variation|Geometric Mean
2596307|NCT02211261|Secondary|Clearance (CL) of PF-06293620 (SAD Cohorts)|Clearance (CL) was calculated as dose/AUCinf, where AUCinf was area under the serum concentration-time profile from time 0 extrapolated to infinite time. This outcome measure only applies to IV arms.|Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||mL/hr||Geometric Coefficient of Variation|Geometric Mean
2596308|NCT02211261|Secondary|Dose-normalized AUClast (AUClast(dn)) of PF-06293620 (SAD Cohorts)|AUClast(dn) of PF-06293620 was calculated as AUClast/dose, where AUClast was area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration.|Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||mcg*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2596367|NCT02209766|Secondary|Cmax in Plasma Baseline-adjusted Total EPA, Multiple Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2596368|NCT02209766|Secondary|Tmax in Plasma Baseline-adjusted Total DHA, Single Dose||Day1-3, 4, 7, 11, 14, 17-18 and 25||||h||Full Range|Median
2596309|NCT02211261|Secondary|Area Under the Serum Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06293620 (SAD Cohorts)|Area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of PF-06293620 was determined using linear/log trapezoidal method.|Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2596310|NCT02211261|Secondary|Dose-normalized AUCinf (AUCinf(dn)) of PF-06293620 (SAD Cohorts)|AUCinf(dn) was calculated as AUCinf/dose, where AUCinf is area under the serum concentration-time profile from time 0 extrapolated to infinite time.|Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||mcg*hr/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2596311|NCT02211261|Secondary|Area Under the Serum Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06293620 (SAD Cohorts)|AUCinf was calculated as AUClast +(Clast*/kel), where AUClast is area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis, kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.|Pre-dose, 1, 4, 8 and 12 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; Days 3, 4, 5, 8, 15, 22, 29, 43, 57, 85|The PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||microgram*hour/milliliter (mcg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2596312|NCT02211261|Primary|Number of Participants With Positive Anti-drug Antibody (ADA) Result|ADA against PF-06293620 in human serum samples was determined following a tiered approach using screening, confirmation, and titer/quantification by semi-quantitative enzyme linked immunosorbent assay (ELISA). Endpoint titer >=1.88 was considered positive.|Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts|The safety analysis population included all participants who received any amount of dose of study medication.|||participants|||Number
2596313|NCT02211261|Primary|Number of Participants With Dose Limiting or Intolerable Adverse Events|Dose limiting or intolerable AEs were originally planned to be collected. However, this outcome measure was not actually summarized, since collection and monitoring of treatment-emergent AEs was performed during the study, and deemed sufficient to ensure the participants safety.|Days 1 to 85 for SAD cohorts; Days 1 to 169 for MAD Cohorts|Data for this outcome measure were not collected.||||||
2596314|NCT02211261|Primary|Number of Participants With All-Causality and Treatment Related Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 85 (for SAD cohorts) or Day 169 (for MAD cohorts) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs. Causality with the study treatment was determined by the investigator.|Days 1 to 85 for SAD cohorts and Days 1 to 169 for MAD cohorts; participants with positive anti-drug antibody (ADA) results were followed up to stabilization of ADA titers or up to 9 months after Day 169 visit.|The safety analysis population included all participants who received any amount of dose of study medication.|||participants|||Number
2596315|NCT02210689|Primary|Number of Participants With Both a Clinical and a Bacteriological Cure (Nugent Score <4), Evaluated at Visit 2 Test-of-cure (Study Day 22-30).|"Clinical Cure is defined as resolution of clinical signs and symptoms from entry visit as follows:~The original discharge characteristic of bacterial vaginosis has returned to a normal physiological vaginal discharge which varies in appearance and consistency depending on the menstrual cycle,~The whiff test is negative for any amine (fishy) odor,~The saline wet mount is negative for clue cells,~Vaginal fluid pH is < 4.7, using pH paper that measures from 3.6 to 6.1.~A Bacteriological cure is defined as a Nugent score < 4.~The system used a 0-4 scale (Nugent Scoring System 0-10 for Gram-Stained Vaginal Smears) for evaluation of vaginal flora, based on the weighted sum of the following 3 bacterial morphotypes scores calculated from slide examination under oil immersion field:~Lactobacillus: large gram positive rods,~Gardnerella / Bacteroides spp: Small gram variable coccobacilli/small Gram negative rods,~Mobiluncus spp.: thin, curved Gram variable rods"|22 to 30 days||||Participants|||Count of Participants
2596316|NCT02210208|Secondary|Part B Secondary Outcome.|Ability of Mepilex® Transfer Ag to adhere to donor site without slippage.|14 days with 2 visits|ITT population|||Participants|||Count of Participants
2596317|NCT02210208|Secondary|Part A Secondary Outcome.|"Satisfactory fixation of the product over the skin graft was assessed by a series of questions regarding the product assessment of product in place at each visit.~Ability to pass exudate to the secondary dressing was demonstrated by a series of questions regarding the exudate at each visit as well as the adherence of the dressing at removal which would show the ability of the dressing to pass the exudate to the secondary dressing rather than creating eschar between the wound and the dressing."|14 days with 2 visits|ITT population|||Participants|||Count of Participants
2596318|NCT02210208|Primary|Part B|Part B: The healing percentage of donor sites (defined as greater than 95% epithelialization, verified by quantitative photographic analysis).|14 days with 2 visits|ITT population. During the surgery, the Phycisian decided that one patient should not receive any skin graft. Therefore there are only 24 patients in Part A and 18 patients in Part B. At Baseline there were 25 ITT patients evaluated for Part A and 19 patients for Part B.|||Participants|||Count of Participants
2596320|NCT02210195|Primary|Change From Week 0 in Drinking Quantity and Frequency Using Drinks Per Week at Week 8|Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 8 - Week 0). More negative values indicate less use of alcohol.|Week 0 and Week 8||||drinks/week||Standard Deviation|Mean
2596321|NCT02210195|Primary|Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8|Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value).|Week 0 and Week 8||||ng/mg||Standard Deviation|Mean
2596322|NCT02210091|Post-Hoc|Pharmacokinetics (PK): Plasma Half-life Ratio of BAX 855 to ADVATE|This is a descriptive summary of the ratio of plasma half-life in the same subject for BAX 855 compared to ADVATE based on the final covariate model (first observation tabulation).|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set|||hours (hr)||Full Range|Mean
2596323|NCT02210091|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR) of BAX 855 Over Time - Chromogenic Assay|"Pre- and post-infusion levels of Factor VIII (FVIII) following infusion of BAX 855 were used to determine IR.~For participants who underwent PK evaluation, baseline IR was determined from the IR measurement used in the PK analysis. Refer to data in Outcome measure 21- Pharmacokinetics (PK): Incremental Recovery (IR), for the category Chromogenic assay - BAX 855~For participants who did not undergo a PK evaluation, baseline IR was determined at the baseline visit prior to the prophylactic treatment phase and is included in this outcome measure.~Category title includes number of participants [n] < 6 yrs; ≥6 to <12 yrs and the Full Analysis Set, respectively."|Baseline, Week 5 (or 10-15 Exposure Days [EDs], whichever occurs last), Week 12, and Month 6 (Completion/Termination)|Participants from the Full Analysis Set who provided at least data from baseline, Week 5 (or 10-15 EDs, whichever occurred last), Week 12 or Month 6.|||IU/dL : IU/kg||Standard Deviation|Mean
2596324|NCT02210091|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR) of BAX 855 Over Time - One Stage Clotting Assay|"Pre- and post-infusion levels of Factor VIII (FVIII) following infusion of BAX 855 were used to determine IR.~For participants who underwent PK evaluation, baseline IR was determined from the IR measurement used in the PK analysis. Refer to data in Outcome measure 21- Pharmacokinetics (PK): Incremental Recovery (IR), for the category One stage clotting assay - BAX 855~For participants who did not undergo a PK evaluation, baseline IR was determined at the baseline visit prior to the prophylactic treatment phase and is included in this outcome measure.~Category title includes number of participants [n] < 6 yrs; ≥6 to <12 yrs and the Full Analysis Set, respectively."|Baseline, Week 5 (or 10-15 EDs, whichever occurs last), Week 12, and Month 6 (Completion/Termination)|Participants from the Full Analysis Set who provided at least data from baseline, Week 5 (or 10-15 EDs, whichever occurred last), Week 12 or Month 6|||IU/dL : IU/kg||Standard Deviation|Mean
2596325|NCT02210091|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.~The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A non-compartmental model approach was implemented to analyze IR data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set|||IU/dL : IU/kg||Standard Deviation|Mean
2596326|NCT02210091|Secondary|Pharmacokinetics (PK): Volume of Distribution at Steady State (Vss)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.~The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set|||litre (L)||Standard Deviation|Mean
2596327|NCT02210091|Secondary|Pharmacokinetics (PK): Plasma Half-life (T1/2)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.~The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set|||hours (hr)||Standard Deviation|Mean
2596336|NCT02210091|Secondary|Serious Adverse Events (SAEs) Possibly or Probably Related to BAX 855||After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set.|||serious adverse events|||Number
2596892|NCT02203630|Secondary|Number of Days Mechanical Ventilation Needed||Up to 28 days|only participants that required mechanical ventilation|||days|||Number
2596328|NCT02210091|Secondary|Pharmacokinetics (PK): Clearance (CL)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.~The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set|||L/hr||Standard Deviation|Mean
2596329|NCT02210091|Secondary|Pharmacokinetics (PK): Mean Residence Time (MRT)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.~The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set|||hours (hr)||Standard Deviation|Mean
2596330|NCT02210091|Secondary|Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From 0 to ∞ Hours Post-infusion Per Dose, (AUC0-∞/Dose)||(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|The PK parameters were derived using a non-compartmental estimation approach using a flexible sampling design to provide point and interval estimates for summary PK parameter using a batch method. AUC/Dose is not a standard output parameter so this calculation was not done.||||||
2596331|NCT02210091|Secondary|Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From 0 to ∞ Hours Post-infusion (AUC0-∞)|"The first PK infusion was ADVATE and the second PK infusion was BAX 855. All participants undergoing PK assessment had a 72-hour washout period before administration of ADVATE and BAX 855. There were 4 blood draws for PK analysis-1 pre-infusion and 3 post infusion. The timing of the infusion (morning [am] or afternoon [pm]) and the timing of Blood Draws 3 and 4 (3 groups for each blood draw) were determined at randomization.~The sequence was as follows:- Blood Draw 1. within 30 minutes pre-infusion [Day 0]; PK INFUSION - am or pm [Day 0]; Blood Draw 2. 15-30 minutes post-infusion [Day 0]; Blood Draw 3. 3 groups:- 7 hours post-infusion (if am PK infusion) or 4 hours post-infusion (if pm PK infusion) [Day 0], Day 1 am or Day 1 pm; Blood Draw 4. 3 groups:- Day 2, Day 3 or Day 4. A nonlinear mixed effects model approach (population PK) was implemented to analyze PK data. A one-stage clotting assay was used as the primary assay and a chromogenic assay was used to provide supportive data."|(1) within 30 min pre-infusion; (2) 15-30 min post-infusion; (3) Day 0 either 4 or 7 hours post-infusion; Day 1 am; Day 1 pm; (4) Day 2; Day 3; or Day 4|Pharmacokinetic (PK) Analysis Set.|||IU•hr/L||Standard Deviation|Mean
2596332|NCT02210091|Secondary|Positive Post-baseline Binding Antibodies to Factor VIII (FVIII), Polyethylene Glycol-Factor VIII (PEG-FVIII), PEG and Chinese Hamster Ovary (CHO) Proteins|"Binding antibodies to FVIII and PEG-FVIII, as well as to PEG, were measured using enzyme-linked immunosorbent assay (ELISA). Both immunoglobulin G (IgG) and immunoglobulin M (IgM) binding antibodies for FVIII, BAX 855, and PEG were tested at each study visit. Testing for binding antibodies to CHO was performed on citrate-anti-coagulated plasma using an ELISA employing polyclonal anti-human IgG antibodies.~This outcome measure includes antibodies that were transient (antibody developed after exposure to BAX 855 but not present at study termination/completion) and pre-existent (antibody originally present before exposure to BAX 855)."|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set: Data not available for 1 participant in the 6 to <12 years group as participant was prematurely withdrawn from study.|||participants|||Number
2596333|NCT02210091|Secondary|Number of Clinically Significant Changes in Clinical Laboratory Parameters (Hematology, Clinical Chemistry, Lipids)|"The HEMATOLOGY PANEL consisted of complete blood count: hemoglobin, hematocrit, erythrocytes (ie, red blood cell count), leukocytes (ie, white blood cell count) with differential (ie, basophils, eosinophils, lymphocytes, monocytes, and neutrophils), mean corpuscular volume, mean corpuscular hemoglobin concentration, and platelet count.~The CLINICAL CHEMISTRY PANEL consisted of sodium, potassium, chloride, bicarbonate, total protein, albumin, ALT, aspartate aminotransferase (AST), total bilirubin, alkaline phosphatase, blood urea nitrogen, creatinine, and glucose.~The LIPID PANEL consisted of cholesterol, very low density lipoprotein, low density lipoprotein, high density lipoprotein, and triglycerides.~For each laboratory parameter value that changed from normal at baseline to abnormal at any subsequent study visit, the Investigator determined if the value was clinically significant, or not."|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set.|||clinically significant findings|||Number
2596334|NCT02210091|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs|Vital signs: body temperature (°C), respiratory rate (breaths/min), pulse rate (beats/min), and systolic and diastolic blood pressure (mmHg). For each vital sign value that changed from normal at baseline to abnormal at any subsequent study visit, the Investigator determined if the value was clinically significant (i.e. and adverse event), or not.|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set.|||participants|||Number
2596335|NCT02210091|Secondary|Non-serious Adverse Events Possibly or Probably Related to BAX 855||After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|BAX 855 Safety Analysis Set.|||adverse events|||Number
2596337|NCT02210091|Secondary|Hemostatic Efficacy Rating for Bleeding Episodes Treated With BAX 855 at Resolution of Bleed|"Rating Scale for Treatment of Bleeding Episodes (BEs) (4-point ordinal scale):~Excellent: Full relief of pain and cessation of objective signs of bleeding (eg, swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion required for the control of bleeding. Administration of further infusions to maintain hemostasis did not affect this scoring.~Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution.~Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after single infusion. Required more than 1 infusion for complete resolution.~None: No improvement or condition worsens."|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|Participants in the Full Analysis Set who had treated bleeding episodes.|||bleeding episodes|bleeding episodes||Number
2596338|NCT02210091|Secondary|Consumption of BAX 855: Weight-adjusted Dose Per Bleeding Episode||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|Participants in the BAX 855 Safety Analysis Set who had treated bleeding episodes.|||IU/kg|bleeding episodes|Standard Deviation|Mean
2596339|NCT02210091|Secondary|Consumption of BAX 855: Number of Infusions Per Bleeding Episode||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|Participants in the BAX 855 Safety Analysis Set who had treated bleeding episodes.|||infusions||Standard Deviation|Mean
2596340|NCT02210091|Secondary|Consumption of BAX 855: Weight-adjusted Dose of Prophylactic Infusions Per Year (Annualized) Per Participant||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|BAX 855 Safety Analysis Set.|||IU/kg||Standard Deviation|Mean
2596341|NCT02210091|Secondary|Consumption of BAX 855: Weight-adjusted Dose of Prophylactic Infusions Per Month Per Participant||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|BAX 855 Safety Analysis Set.|||IU/kg||Standard Deviation|Mean
2596342|NCT02210091|Secondary|Consumption of BAX 855: Number of Prophylactic Infusions Per Year (Annualized) Per Participant||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|BAX 855 Safety Analysis Set.|||infusions per year||Standard Deviation|Mean
2596343|NCT02210091|Secondary|Consumption of BAX 855: Number of Prophylactic Infusions Per Month Per Participant||During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|BAX 855 Safety Analysis Set.|||infusions per month||Standard Deviation|Mean
2596344|NCT02210091|Secondary|Annualized Bleeding Rate (ABR)|"The annualized bleeding rate (ABR) during the prophylaxis period was assessed based upon each individual bleeding episode, spontaneous or traumatic, recorded in the participant´s diary and/or recorded in the physician/nurse/study site notes.~The annualized bleeding rate was analyzed using a generalized linear model framework assuming a negative binomial distribution with a logarithmic link function and presence or absence of target joints and age cohort as covariates and duration of the observation period in years as offset. Point estimates for the mean and 95% confidence intervals are presented."|During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last|Full Analysis Set: All participants who received at least 1 dose of BAX 855 in either PK or prophylaxis part of study|||bleeding episodes per year||95% Confidence Interval|Mean
2596345|NCT02210091|Primary|Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII)|Inhibitory antibodies to FVIII were measured using the Nijmegen modification of the Bethesda assay. Incidence of an FVIII inhibitory antibody was defined as an inhibitor level ≥0.6 Bethesda units [BU].|After first exposure to BAX 855 until completion of study - approx. 6 months per participant.|Participants in the BAX 855 Safety Analysis Set who developed an inhibitor at any time plus participants who did not develop an inhibitor, had 50 or more exposure days (EDs) to BAX 855 and had FVIII Inhibitory test results after 50 EDs.|||participants|||Number
2596346|NCT02210065|Primary|Success Rate of Cytotoxic T Cells|Treatment considered a success if the patient does not require initiation of cytomegalovirus (CMV) anti-viral therapy.|28 days||||Participants|||Count of Participants
2596347|NCT02210065|Primary|Number of Participants With Non-Relapse Mortality|Non-relapse mortality defined as death because of causes other than relapse of the underlying hematological malignancy.|6 months||||Participants|||Count of Participants
2596348|NCT02210052|Primary|Number of Procedures in Which Temperature of Screws Increased|The study will measure for increased temperature in pedicle screws adjacent to lumbar facet joints during radiofrequency neurotomy (RFN). Temperatures will be recorded by placing a thermistor probe on the surface of the adjacent hardware.|2 hours|There were 6 participants, but some participants had more than 1 procedure. There were a total of 10 procedures analyzed.|||procedures|Procedures||Number
2596349|NCT02210039|Primary|Number of Participants With Tolerability of the Procedure|We were monitoring the number of participants able to tolerate the procedure. All six participating subjects have been asked for a feedback about tolerability of the procedure using a specific tolerability questionnaire.|During the procedure|All six study participants completed the study and the obtained data has been analyzed|||Participants|||Count of Participants
2596350|NCT02210000|Secondary|Trough Plasma Concentration of Camicinal on Day 28 and Day 84|A pre-dose blood sample was collected on Days 28 and 84 for pharmacokinetic analysis. This analysis was applicable only for Camicinal arm and thus, no participants from Placebo arm were analyzed.|Day 28 and Day 84|Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.|||NANOGRAM PER MILLILITER (NG/ML)||Standard Deviation|Mean
2596358|NCT02210000|Primary|Percentage of Responders Based on the Fullness/Early Satiety Subscale (Responders) as Assessed by Gastrointestinal Cardinal Symptom Index-Daily Diary (GCSI-DD) at Week 12|The GCSI-DD consists of nine symptom severity items covering the following domains: nausea/vomiting; fullness/early satiety, and bloating. In addition, the GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Participants were asked to rate each symptom on a 6-point scale from 0 to 5 with lower scores representing less symptom severity and higher scores indicating more severe symptoms. Fullness/early satiety response is defined as an improvement from Baseline by at least one point in the weekly average for the subscale. A participant was defined as a responder if the participant's weekly average change from Baseline in the fullness/early satiety response score improved by at least 1 point. Percentage of participants showing response were presented.|Week 12|Intent-to-treat (ITT) Population comprised of all randomized participants.|||Percentage of responders|||Number
2596351|NCT02210000|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), and Adverse Events Leading to Discontinuation of the Study Drug|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. Any AE or SAE that led discontinuation of the study drug either by participant or by investigator was considered as an AE leading to discontinuation of the study drug.|Up to end of follow up (100 days)|Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.|||Participants|||Count of Participants
2596352|NCT02210000|Secondary|Number of Participants With Change From Baseline Clinical Chemistry Abnormalities of PCI by Treatment and Visit Over Period|Clinical chemistry laboratory analysis was performed at screening (fasted) and during the study at each indicated time point. Albumin low (<30 G/L), calcium low (<2 or >2.75 millimoles per Liter [mmol/L]), creatinine (>44 micromoles per Liter change from baseline), Glucose (<3 or >18 mmol/L), potassium (<3.0 or >5.5 mmol/L), sodium (<130 or >150 mmol/L), and carbon di oxide (CO2) (<18 or >35 mmol/L) were analyzed for their low (L) or high (H) values. Participants with abnormalities in changes from Baseline values were recorded. Change from Baseline is the post-Baseline value minus the Baseline value.|Up to 100 days|Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.|||Participants|||Count of Participants
2596353|NCT02210000|Secondary|Number of Participants With Change From Baseline in Hematological Abnormalities of PCI by Treatment and Visit Over Period|Hematology analysis was performed at screening (fasted) and during the study at each indicated time point. Participants with abnormalities in changes from Baseline values were recorded. Total absolute neutrophil count (tANC <1.5 Giga per Liter [G/L]), hemoglobin (<25 or >25 G/L), hematocrit (<0.075 or >0.075 %), platelet count (<100 or >500 G/L), lymphocytes low (<0.8 G/L), and white blood cells (WBC <3 G/L or >20G/L) were analyzed for their low (L) or high (H) values. Change from Baseline (CFB) was the post-Baseline value minus then Baseline value. Baseline was defined as last non-missing measurement prior to dosing. One participant was randomized to Placebo arm; however, was included within the Camicinal treatment group as they reported at least one PK trough concentration >53 nano-grams per milliliter (ng/mL).|Up to 100 days|Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.|||Participants|||Count of Participants
2596354|NCT02210000|Secondary|Number of Participants With Normal and Abnormal 12-lead Electrocardiogram (ECG) Measurements Over 100 Days|The 12-lead ECG was analyzed as a measure of safety and tolerability. Number of participants with normal ECG, abnormal clinically significant, and abnormal clinically not significant ECG were reported. PR interval of < 110 and > 220 milliseconds (msec), QRS interval of <75 and > 110 msec, absolute QTc interval of > 450 to ≤ 480 or > 480 to ≤ 500 or >500 msec, and increase from Baseline in QTc of > 30 to ≤ 60 msec or >60 msec was considered as of abnormal.|Up to 100 days|Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.|||Participants|||Count of Participants
2596355|NCT02210000|Secondary|Number of Participants With Change From Baseline (Day 1) in Heart Rate of PCI Over 100 Day|Abnormal values of heart rate over 100 days was analyzed and reported. Participants were counted only once per parameter. Participant may have had more than 1 abnormal parameter. Only worst post baseline CFB values were considered. The categories mentioned for data values indicate the heart rate ranges of clinical concern.|Up to 100 days|Safety Population. One participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.|||Participants|||Count of Participants
2596356|NCT02210000|Secondary|Number of Participants With Change From Baseline (Day 1) in Blood Pressure of Potential Clinical Importance (PCI) Over 100 Days|Abnormal values of systolic and diastolic blood pressure were measured. If the value for a participant at a given visit was outside the PCI, the participants were further categorized as per the increase or decrease of systolic blood pressure (SBP) and diastolic blood pressure (DBP) from Baseline by 10, 20 and 40 millimeters of mercury (mm of Hg). Number of participants with absolute (ABS) SBP (>160 mm Hg) and ABS DBP (100 mm Hg) were also analyzed. Change from Baseline (CFB) is the post-Baseline value minus the Baseline value. Participants were counted only once per parameter. Participant may have had more than 1 abnormal parameter. Only worst post-Baseline CFB values were considered. The categories mentioned for data values indicate the blood pressure ranges of clinical concern.|Up to 100 days|Safety Population comprised of participants who received at least one dose of the study drug and were followed-up for at least one post-Baseline safety assessment; however, one participant randomized to Placebo arm had quantifiable concentration of Camicinal in blood and therefore was analyzed in the Camicinal group.|||Participants|||Count of Participants
2596357|NCT02210000|Secondary|Change From Baseline in Individual Items, Subscales and Total Score of GCSI-DD at Week 12|Items of GCSI-DD for gastroparesis (GP) symptom assessment included: 3-nausea, 4-feeling full after meals, 5-bloating, 6-unable to finish normal meal, 7-retching, 8-vomiting, 9-stomach visibly larger, 10-stomach fullness, 11-loss of appetite, 12-upper abdominal pain, 13-upper abdominal discomfort and 14-overall severity of GP symptoms. Each symptom rated on a 6-point scale from 0 to 5 where 0 indicated absence of symptom and higher score indicated greater severity of symptom. Score of nausea/vomiting subscale was mean of items 3, 7, 8; fullness/early satiety subscale was mean of items 4, 6, 10, 11; bloating subscale was mean of items 5, 9. Total GCSI-DD score was mean of 3 subscales. For all, 0 indicated absence of symptom and higher score indicated greater severity of symptoms. Baseline was defined as weekly average of last 7 daily scores recorded during screening period. Change from Baseline was calculated by subtracting mean score for Baseline from weekly average score of Week 12.|Baseline (Screening) and Week 12|ITT Population. Only those participants available at the time of assessment were included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2596893|NCT02203630|Secondary|Number of Direct Current (DC) Cardioversion Events||Up to 28 days||||DC cardioversion events|||Number
2596373|NCT02209610|Primary|Quadriceps Twitch Force and Voluntary Activation (% Change From Baseline)|During a 2-min maximal voluntary quadriceps contraction, central and peripheral fatigue will develop progressively and significantly more in HF vs. CTRLs.|During (20 second intervals) and 1 minute after exercise on study day||||percentage change||Standard Deviation|Mean
2596374|NCT02209610|Primary|Maximal Voluntary Quadriceps Force [% Change From Baseline]|Following dynamic single leg knee extension exercise for a given duration (4-8 min), the decline in maximal voluntary contraction force will be measured.|1 minute after exercise on study day||||percentage change||Standard Deviation|Mean
2596375|NCT02209597|Primary|Area Under the Curve (AUC0-24) Ratio for Racemic Bupropion|Area under the curve (AUC) generic/Area under the curve (AUC) brand bupropion|For 24 hours approximately every 6 weeks||||percentage of Brand||Full Range|Mean
2596376|NCT02209532|Secondary|Anatomic Distribution of Lymph Nodes|To determine the anatomic distribution of lymph nodes|Day 0|180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).|||confirmed lymph nodes|Lymph Nodes||Number
2596377|NCT02209532|Secondary|Safety of Interstitial Injection of ICG Defined as the Number of Adverse Effects Related to ICG|To assess the safety of interstitial injection of ICG for intraoperative lymphatic mapping, as measured by number of subjects experiencing adverse effects related to the study treatment.|Day 0 to Day 30|180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).|||Number of subjects|||Number
2596378|NCT02209532|Secondary|Identification of Lymph Nodes Following Lymphatic Channels Defined as the Number of Subjects in Which Confirmed Lymph Nodes Were Identified by Following a Lymphatic Channel With Either PINPOINT or Blue Dye.|To determine the proportion of lymph nodes identified from following lymphatic channels|Day 0|180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).|||Number of Subjects|||Number
2596379|NCT02209532|Secondary|Effectiveness of PINPOINT and Blue Dye in the Identification of Bilateral Lymph Nodes Defined as the Number of Subjects in Which Lymph Nodes Were Identified Bilaterally With Either PINPOINT or Blue Dye.|To evaluate the effectiveness of PINPOINT and Blue dye in the identification of bilateral lymph nodes (confirmed to be lymphoid tissue).|Day 0|180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).|||Number of Subjects|||Number
2596380|NCT02209532|Secondary|Effectiveness of PINPOINT and Blue Dye in the Identification of at Least One Lymph Node Defined as the Number of Subjects in Which at Least One Confirmed Lymph Node Was Identified With Either PINPOINT or Blue Dye|To evaluate the effectiveness of PINPOINT and Blue dye in the identification of at least one lymph node (confirmed to be lymphoid tissue) per subject.|Day 0|180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).|||Number of Subjects|||Number
2596381|NCT02209532|Primary|Effectiveness of PINPOINT and IC2000 in the Identification of Lymph Nodes Defined as the Proportion of Confirmed Lymph Nodes Identified|To assess the effectiveness of intraoperative PINPOINT Near Infrared Fluorescence Imaging in the identification of lymph nodes in subjects with uterine and cervical malignancies who are undergoing lymph node mapping.|Day 0|All analyses were completed using the number of lymph nodes identified.|||Confirmed Lymph Nodes|Confirmed Lymph Nodes||Number
2596382|NCT02209519|Secondary|Time to Recurrence of BV in Women Whose Partner Received Metronidazole Versus Females Whose Partners Did Not Receive Metronidazole|time to recurrence measured in days|from the end of week 1 up to 16 weeks|unable to collect data due to lab issues||||||
2596383|NCT02209519|Primary|Number of Female Partners Whose Male Partners Received Metronidazole Versus Females Whose Male Partners Did Not Receive Metrodiazole With Recurrence of BV in the Female|"the female partners will be assessed for recurrence/persistence of BV. tRecurrence/persistence is measured by - Positive 3 - 4 Amsel criteria (vaginal pH > 4.7, clue cells, positive whiff test, homogenous discharge); Nugent score >3~No Recurrence/Persistence is measured by:~- Presence of 0 -2 Amsel criteria; Nugent score 0-3."|16 weeks post start of receipt of study drug|those completing the study|||Participants|||Count of Participants
2596384|NCT02209506|Secondary|CLr: Renal Clearance of MLN3126 and Its Metabolite|CLr is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time, calculated as the amount of drug excreted in the urine divided by the area under the plasma concentration-time curve, expressed in liter per hour (L/hr). M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|Data is not reported because the study was terminated early at Cohorts 2A and 1B, yielding limited data for only 2 dose levels of MLN3126 in non-Japanese participants and one dose level in Japanese participants. Therefore the analyses to determine urine PK parameters was not performed.||||||
2596385|NCT02209506|Secondary|Fe (0-4): Fraction of Dose of MLN3126 and Its Metabolite Excreted Unchanged in Urine From 0 to 4 Hours Post Dose|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 4 hours) post-dose|Data is not reported because the study was terminated early at Cohorts 2A and 1B, yielding limited data for only 2 dose levels of MLN3126 in non-Japanese participants and one dose level in Japanese participants. Therefore the analyses to determine urine PK parameters was not performed.||||||
2596482|NCT02208310|Secondary|Crohn's Related Hospitalizations|Dichotomous (0/1) endpoint for each subject, depending on whether a CD-related hospitalization occurred. Relatedness to Crohn's disease as judged by the DSMB. Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.|Day 180||||CD-related hospitalization occurred|||Number
2596386|NCT02209506|Secondary|Ae (0-4): Amount of MLN3126 and Its Metabolite Excreted in Urine From 0 to 4 Hours Post Dose|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 4 hours) post-dose|Data is not reported because the study was terminated early at Cohorts 2A and 1B, yielding limited data for only 2 dose levels of MLN3126 in non-Japanese participants and one dose level in Japanese participants. Therefore the analyses to determine urine PK parameters was not performed.||||||
2596387|NCT02209506|Secondary|Ratio of AUC(0-tau): Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Between MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||ratio||Standard Deviation|Mean
2596388|NCT02209506|Secondary|Cmax Ratio: Ratio of Maximum Plasma Concentration Between MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||ratio||Standard Deviation|Mean
2596389|NCT02209506|Secondary|Rac AUC(0-96): Accumulation Ratio of AUC(0-96) for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||ratio||Standard Deviation|Mean
2596390|NCT02209506|Secondary|Cavss: Average Plasma Concentration for MLN3126 and Its Metabolite at Steady State on Day 15|M-I is the inactive metabolite of MLN3126.|Day 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||ng/mL||Standard Deviation|Mean
2596391|NCT02209506|Secondary|Cav: Average Plasma Concentration for MLN3126 and Its Metabolite on Day 1|M-I is the inactive metabolite of MLN3126.|Day 1: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||ng/mL||Standard Deviation|Mean
2596392|NCT02209506|Secondary|Terminal Phase Elimination Half-life (T1/2) for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||hours||Standard Deviation|Mean
2596393|NCT02209506|Secondary|CL/F: Apparent Oral Clearance of MLN3126 and Its Metabolite After Multiple Dosing (at Steady State)|M-I is the inactive metabolite of MLN3126.|Day 1: predose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||liter per hour (L/hr)||Standard Deviation|Mean
2596394|NCT02209506|Secondary|AUC (0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: predose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||ng*hr/mL||Standard Deviation|Mean
2596395|NCT02209506|Secondary|AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Post Dose for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||ng*hr/mL||Standard Deviation|Mean
2596396|NCT02209506|Secondary|AUC (0-last): Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||ng*hr/mL||Standard Deviation|Mean
2596397|NCT02209506|Secondary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||nanogram*hour per milliliter (ng*hr/mL||Standard Deviation|Mean
2596398|NCT02209506|Secondary|Tmax- Time to Reach the Cmax for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The PK analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||hours||Full Range|Median
2596399|NCT02209506|Secondary|Cmax: Maximum Plasma Concentration for MLN3126 and Its Metabolite|M-I is the inactive metabolite of MLN3126.|Days 1 and 15: pre-dose and at multiple timepoints (up to 96 hours) post-dose|The pharmacokinetic (PK) analysis set included all participants who received the study drug and had at least 1 measurable plasma concentration for either MLN3126 or its M-I metabolite.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2596400|NCT02209506|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose|The percentage of participants who meet markedly abnormal criteria designated by Takeda Global Research and Development Center, Inc. (TGRD). Criteria for markedly abnormal vital signs included body temperature, systolic blood pressure, diastolic blood pressure and pulse rate.|Baseline up to 7 days after last dose of study drug (Day 22)|Safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2596465|NCT02208999|Secondary|Patients' Opinion on the Evolution of Pain|- Pain relief compared to what the patient with a de novo implant, felt before the implantation at 12 months and at 24 months.|From baseline until the end of the study at 24 months|"Percentage of de novo patients for whom pain relief before the implantation was improved to very improved at 12 and 24 months"|||Participants|||Count of Participants
2596401|NCT02209506|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose|The percentage of participants with any markedly abnormal, according to Takeda criteria, standard safety laboratory values, including hematology, serum chemistry, and urinalysis, during the treatment period.|Baseline up to 7 days after last dose of study drug (Day 22)|Safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2596402|NCT02209506|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Electrocardiogram Measurements at Least Once Post Dose|A standard 12-lead ECG was performed. The percentage of participants with markedly abnormal electrocardiogram (ECG) findings during the study.|Baseline up to 7 days after last dose of study drug (Day 22)|Safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2596403|NCT02209506|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)|A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 7 days after last dose of study drug (Day 22)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2596404|NCT02209454|Secondary|t1/2|AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax) and t1/2 will be summarized descriptively.|Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).|||h||95% Confidence Interval|Geometric Mean
2596405|NCT02209454|Secondary|Tmax|AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax).|Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).|||h||Full Range|Median
2596406|NCT02209454|Primary|AUC(0-t)|The absence of any difference in the rate and extent of absorption will be demonstrated if the 90% CI for the geometric mean ratio between Test and Reference formulations is within the range 80.00% - 125.00% for AUC(0-t).|Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).|||h*ng/mL||95% Confidence Interval|Geometric Mean
2596407|NCT02209454|Secondary|AUC(0-∞)|AUC(0-∞) will be analysed similarly to AUC(0-t) and Cmax. Time to achieve maximum plasma concentration (tmax) and t1/2 will be summarized descriptively.|Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).|||h*ng/mL||95% Confidence Interval|Geometric Mean
2596408|NCT02209454|Primary|Cmax|The absence of any difference in the rate and extent of absorption will be demonstrated if the 90% CI for the geometric mean ratio between Test and Reference formulations is within the range 80.00% - 133.00% for Cmax.|Up to 24h post-dose (pre-dose, T+5', T+10', T+15', T+20', T+30', T+40', T+50', T+1h, T+1.25h, T+1.5h, T+2h, T+3h, T+3.5h, T+4h, T+5h, T+6h, T+8h, T+12h and T+24h post-dose).|Analyses of the primary PK variables were conducted on all randomised subjects who received at least one dose of DKP.TRIS (PK population) and on all subjects in the PK population who did not experience major protocol violations (PP population).|||ng/mL||95% Confidence Interval|Geometric Mean
2596409|NCT02209272|Secondary|Anesthetic Infiltration Duration|Anesthetic infiltration duration will be measured using a timer on the ultrasound machine, with goal administration between 20-40 seconds.|baseline||||seconds||Standard Deviation|Mean
2596410|NCT02209272|Secondary|VAS for Pain Score During Subsequent Hip Joint Injection (Local Anesthetic Efficacy)|"The Visual Analog Scale (VAS) for Pain is a validated tool used to measure pain. A 100mm horizontal line anchored by no pain (score of 0) and pain as bad as it could be (score of 100)."|baseline to 5-10 minutes later -- immediately after hip joint injection||||score on a scale||Standard Deviation|Mean
2596411|NCT02209272|Primary|VAS for Pain Score During Local Anesthesia Infiltration|"The Visual Analog Scale (VAS) for Pain is a validated tool used to measure pain. A 100mm horizontal line anchored by no pain (score of 0) and pain as bad as it could be (score of 100)."|baseline to 5-10 minutes later -- immediately after local anesthetic injection administration||||score on a scale||Standard Deviation|Mean
2596412|NCT02209259|Secondary|Patient Reported Outcomes Measurement Information System (PROMIS) Depression|A computerized assessment of depression measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is worse than the average and a T score less than 50 is better than the average.|1 day||||T-score||Standard Deviation|Mean
2596413|NCT02209259|Secondary|Pain Intensity|10 point pain scale, where 0 is no pain and 10 is the most pain|1 day||||units on a scale||Standard Deviation|Mean
2596414|NCT02209259|Primary|Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity|A computerized assessment of upper extremity physical function measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is better than the average and a T score less than 50 is worse than the average.|1day||||T-score||Standard Deviation|Mean
2596415|NCT02209181|Secondary|Subject Global Evaluation|How the subject would rate the study medication as a pain-reliever on a scale of 0-4 (where 0=poor and 4=excellent).|Completed at hour 12 or at time of the first rescue medication (hours post dose).|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||percentage of participants|||Number
2596894|NCT02203630|Secondary|Use of Corticosteroid|number of days participants received a corticosteroid|Up to 28 days||||days|||Number
2596416|NCT02209181|Secondary|Duration of Pain Relief After Dosing (Time to Rescue Medication)|Time (minutes) to rescue medication was measured as the elapsed time from when the investigational product was given until the time rescue medication was given.|Completed at time of the first rescue medication (hours post dose), estimated up through Day 2|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||minutes||95% Confidence Interval|Median
2596417|NCT02209181|Secondary|Pain Relief (PAR) Scores at 24 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|24 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596418|NCT02209181|Secondary|Pain Relief (PAR) Scores at 16 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|16 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596419|NCT02209181|Secondary|Pain Relief (PAR) Scores at 12 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|12 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596420|NCT02209181|Secondary|Pain Relief (PAR) Scores at 11 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|11 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596421|NCT02209181|Secondary|Pain Relief (PAR) Scores at 10 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|10 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596422|NCT02209181|Secondary|Pain Relief (PAR) Scores at 9 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|9 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596423|NCT02209181|Secondary|Pain Relief (PAR) Scores at 8 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|8 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596424|NCT02209181|Secondary|Pain Relief (PAR) Scores at 7 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|7 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596425|NCT02209181|Secondary|Pain Relief (PAR) Scores at 6 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|6 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596426|NCT02209181|Secondary|Pain Relief (PAR) Scores at 5 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|5 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596427|NCT02209181|Secondary|Pain Relief (PAR) Scores at 4 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|4 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596428|NCT02209181|Secondary|Pain Relief (PAR) Scores at 3 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|3 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596429|NCT02209181|Secondary|Pain Relief (PAR) Scores at 2 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|2 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596430|NCT02209181|Secondary|Pain Relief (PAR) Scores at 1.5 Hours Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|1.5 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596431|NCT02209181|Secondary|Pain Relief (PAR) Scores at 1 Hour Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|1 hour post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596432|NCT02209181|Secondary|Pain Relief (PAR) Scores at 45 Minutes Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|45 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596433|NCT02209181|Secondary|Pain Relief (PAR) Scores at 30 Minutes Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|30 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596434|NCT02209181|Secondary|Pain Relief (PAR) Scores at 15 Minutes Post Dose|Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).|15 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596481|NCT02208310|Secondary|Steroid Prescription Given (Dichotomous 0/1)|Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No steroid prescriptions occurred|Day 180||||Steroid prescription occurred|||Number
2596435|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 24 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596436|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 16 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596437|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 12 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596438|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 11 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596439|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 10 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596440|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 9 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596441|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 8 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596442|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 7 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596443|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 6 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596444|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 5 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596445|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 4 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596446|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 3 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596447|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 2 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596448|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 1.5 hours post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596449|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 1 hour post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596450|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 45 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596451|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 30 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596452|NCT02209181|Secondary|Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose|Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.|Baseline to 15 minutes post dose|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596453|NCT02209181|Primary|Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)|Time-weighted sum of pain intensity difference by first multiplying each pain intensity difference (PID) score by the time from the previous time point, and adding them together for each scheduled time point within 0-6 hours. Time points included 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours. The minimum SPID 0-6 was -30 and the maximum SPID 0-6 was 60, where higher is better. Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain).|6 Hours|Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2596454|NCT02209064|Other Pre-specified|Number of Patients in Whom Pericardial Access Was Achieved With the EpiAccess System|Number of patients in whom the EpiAccess system was equivalently able to access the pericardial space, compared with standard of care minimally invasive access techniques,documented by using intra procedure or post procedure clinician survey|Access through end of procedure||||participants|||Number
2596455|NCT02209064|Secondary|Percentage of Participants With a Pericardial Effusion of >80ml|Secondary endpoint will measure whether or not there was a pericardial effusion greater than 80ml.|Access through discharge/approximately 4 days||||percentage of participants|||Number
2596456|NCT02209064|Secondary|Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System|EpiAccess will provide equivalent or better access (defined as guidewire entry into the pericardial space) as compared to access with standard of care minimally invasive, subxiphoid access techniques.|access through procedure completion||||percentage of patients|||Number
2596457|NCT02209064|Primary|Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System|EpiAccess device shall be used to access the pericardial space with measurements tracked noting if access was achieved. The percentage of patients in whom pericardial access was successful will be reported.|Through discharge / approx 4 days|Percentage of patients in whom epicardial access was successful using the EpiAccess system. Successful access is defined as the ability to introduce a guide wire into the epicardial space.|||percentage of patients|||Number
2596458|NCT02208999|Secondary|Evolution of the Use of Level 3 Analgesics|Mean posology of level 3 analgesics at each follow-up (at 1 year and at 2 years). The posology was estimated in oral morphine equivalent dosage. At 1 year, 14 patients had a level 3 analgesic and at 2 years 18 patients had this type of analgesic. The posology was available for respectively 4 and 16 patients|From baseline until the end of the study at 24 months|Implanted patients (de novo implants) at 12 months and at 24 months with at least one level 3 analgesic treatment|||MG||Standard Deviation|Mean
2596459|NCT02208999|Primary|Average Pain Score Over the Last 8 Days, Evaluated by Numerical Scale at 1 Year, and at 2 Years.|The pain was evaluated with a numerical scale from 0 to 10. 0 = no pain and 10 = most intense pain. This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.|From baseline until the end of the study at 24 months.|Implanted patients (de novo implants)|||units on a scale||95% Confidence Interval|Mean
2596460|NCT02208999|Secondary|Evolution of Quality of Life (SF-12) - Mental Score|"Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) mental score at 12 and 24 months. An increase of this score indicates an improvement in mental quality of life."|From baseline until the end of the study at 24 months|Percentage of de novo patients with an increase of SF-12 mental score at 12 and 24 months|||Participants|||Count of Participants
2596461|NCT02208999|Secondary|Percentage of Patients With Anxiety and Depression Disorders|Evolution of the rate of patients with anxiety and depression disorders at12 and 24 months.|From baseline until the end of the study at 24 months|Percentage of de novo patients with anxiety and depression disorders at 12 and 24 months|||percentage of included de novo patients||95% Confidence Interval|Number
2596462|NCT02208999|Secondary|Patients' Willingness to Restart the Treatment|Patients' willingness to restart the treatment at 12 months and at 24 months.|From baseline until the end of the study at 24 months|Percentage of de novo patients willing to restart treatment at each follow-up (at 1 year and at 2 years)|||Participants|||Count of Participants
2596463|NCT02208999|Secondary|Evolution of Quality of Life (SF-12) - Physical Score|"Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) physical score at 12 and 24 months. An increase of this score indicates an improvement in physical quality of life."|From baseline until the end of the study at 24 months|Percentage of de novo patients with an increase of SF-12 at 12 and 24 months|||Participants|||Count of Participants
2596464|NCT02208999|Secondary|Evolution of the Use of Other Pain Treatments|Rate of primary implanted patients who took at least one analgesic treatment at each follow-up (at 1 year and at 2 years)|From baseline until the end of the study at 24 months|Implanted patients (de novo implants) at 12 months and at 24 months with at least one analgesic treatment|||Participants|||Count of Participants
2596483|NCT02208310|Primary|Incidence of Nephrolithiasis|Incidence of nephrolithiasis associated with hypercalcemia (>10.8mg/dl) documented by imaging Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.|Day 180||||Participants|||Count of Participants
2596466|NCT02208999|Secondary|Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 30% of the Overall Average Pain, Evaluated by Numerical Scale|"Percentage of implanted patients (de novo implants) with an improvement of at least 30% at 12 and 24 months after inclusion for:~pain at the present time~usual pain over the past 8 days~the most severe pain in the last 8 days"|From baseline until the end of the study at 24 months|Percentage of de novo patients with an improvement of at least 30% for pain at 12 and 24 months after inclusion|||% of patients||95% Confidence Interval|Number
2596467|NCT02208999|Primary|Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 50% of the Overall Average Pain Over the Last 8 Days, Evaluated by Numerical Scale at the First Follow-up Visit, at 1 Year, and 2 Years.|Percentage of patients (de novo implants) having a reduction of usual pain over the past 8 days of at least 50% at 12 and 24 months. The pain was measured with a numerical scale from 0 to 10 (0 = no pain and 10 = most intense pain). This data has been provided by 71 patients at 1 year and by 70 patients at 2 years.|From baseline until the end of the study at 24 months.|Implanted patients (de novo implants)|||percentage of patients||95% Confidence Interval|Number
2596468|NCT02208843|Secondary|Disease Control (CR, PR, Stable Disease [SD]) as Assessed by the Investigator According to RECIST 1.1|As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.|Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days|Treated Set (TS): The TS includes all patients who were documented to have taken at least 1 dose of afatinib.|||Percentage of participants||95% Confidence Interval|Number
2596469|NCT02208843|Secondary|Progression-free Survival (PFS) as Assessed by the Investigator According to RECIST 1.1.|Progression-free survival (PFS) is the time from treatment start to disease progression (or death if the patient died before progression). PFS as assessed based on investigator review according to the response evaluation criteria in solid tumours (RECIST) version 1.1.|Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days|Treated Set (TS): The TS includes all patients who were documented to have taken at least 1 dose of afatinib.|||Months||95% Confidence Interval|Median
2596470|NCT02208843|Primary|Objective Tumour Response (Complete Response [CR], Partial Response [PR]) as Assessed by the Investigator According to the RECIST Version 1.1|As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions|Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days|Treated Set (TS): The TS includes all patients who were documented to have taken at least 1 dose of afatinib.|||Percentage of participants||95% Confidence Interval|Number
2596471|NCT02208349|Secondary|Overall Success|Overall success rate will be defined as the total number of successful placements divided by the total number of patients treated.|up to 24 hours, duration of the study (approximately 34 months)||||Participants|||Count of Participants
2596472|NCT02208349|Primary|Number of Participants With Successful First Intubation Attempt (First Pass Attempt)|Endotracheal Intubation (ETI) attempt will be defined as tip of the laryngoscope blade passing the patient's lips. First attempt success rate will be defined as the number of successful placements occurring on the first attempt to place the endotracheal tube.|less than 24 hours, collected for the duration of the study (approximately 34 months)||||Participants|||Count of Participants
2596473|NCT02208310|Secondary|Participants With at Least One Crohn's Related Emergency Department (ED) Visit|Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No CD-related ED visits occurred in the 1 subject|Day 180||||participants|||Number
2596474|NCT02208310|Secondary|Change in Fatigue Measurements|"Change in FACIT-F scale over the year. Scale is 0-160 with 0 being no fatigue and 160 being extreme fatigue. A positive change indicates worsening in symptoms and a negative change indicates an improvement.~Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here."|Day 180||||units on a scale|||Number
2596475|NCT02208310|Secondary|Quality of Life Measure Changes|"change in quality of life measures based on Inflammatory bowel disease questionnaire (IBD-Q).~Scale from 0 to 224 with 0 being the poorest quality of life and 224 being the highest quality of life. A positive change indicates improvement while a negative change indicates worsening.~Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here."|Day 180||||units on a scale|||Number
2596476|NCT02208310|Secondary|Percent With Escalation of Therapy|Patients who had to have a change in therapy Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.|Day 180||||Participants|||Count of Participants
2596477|NCT02208310|Secondary|Changes in Fecal Calprotectin|Originally planned to collect at Day 180 and Day 360. Results were not collected on any subjects, as the one participant did not provide a stool sample.|1 year|Results were not collected on any subjects||||||
2596478|NCT02208310|Secondary|Change in C-reactive Protein|Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. The delta between first (baseline) and last CRP (Day 180) is reported here.|Day 180||||mg/dL|||Number
2596479|NCT02208310|Secondary|Change in Modified Harvey-Bradshaw Index (HBI Without Examination)|"modified Harvey-Bradshaw is a disease assessment scale. 0 is the lowest score and would be considered remission. Scale ranges to over 16 (upper limit is defined by the number of bowel movements in the prior day) with numbers over 16 being severe disease. A positive change (such as that indicated below) therefore references slightly worsening disease while a negative change references improving disease.~Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. 1 subject had an increase of 1 unit on the modified HBI."|Day 180||||units on a scale (0-16)|||Number
2596480|NCT02208310|Secondary|Crohn's Related Surgeries (Dichotomous 0/1 Per Subject)|Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here. No CD-related surgeries occurred in the 1 subject|Day 180||||CD-related surgery occurred|||Number
2596484|NCT02208310|Primary|Hypercalcemia|Hypercalcemia is presented as number of participants with Calcium >10.8 mg/dl Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here.|Day 180||||Participants|||Count of Participants
2596485|NCT02208310|Primary|Composite Endpoint: Number of Participants With (Any of) a CD-related Hospitalization, CD-related Surgery, CD-related ER Visits and Steroid Prescriptions|"Composite endpoint of (any of) Crohn's disease(CD)-related hospitalizations, CD-related surgeries, CD-related ER visits, or steroid prescriptions.~Originally planned to collect at Day 180 and Day 360. Only 1 subject remained in the study to Day 180 so that data is presented here."|Day 180||||participants|||Number
2596486|NCT02208089|Secondary|Progression Rate|The number of participants with possible keratoconus disease progression after treatment defined by a ≥1.5D increase in Kmax, anterior and posterior K2 (maximum local corneal curvature, maximum anterior and posterior meridional corneal curvature) measured using a Pentacam HD corneal tomographer (www.oculus.de).|6 months postoperative - 24 months postoperative||||Participants|||Count of Participants
2596487|NCT02208089|Secondary|Change in Kmax - Maximum Local Anterior Corneal Surface Curvature on Tomography Map|Pentacam (www.oculus.de) measure: Maximum local curvature (Kmax). Reduction in dioptric value = corneal flattening|Preoperative vs 24 months postoperative||||Dioptres||Standard Deviation|Mean
2596488|NCT02208089|Secondary|Clinically Significant Visual Loss|Number of participants with loss of ≥2 lines (≥0.20 LogMAR units) corrected distance visual acuity (CDVA)|preoperative vs 24 months postoperative||||Participants|||Count of Participants
2596489|NCT02208089|Secondary|Clinically Significant Visual Gain|Number of participants with gain of ≥2 lines (≥0.20 logMAR units) corrected distance visual acuity (CDVA) on a standard 5 letter per line EDTRS visual acuity testing chart|Preoperative vs 24 months postoperative||||Participants|||Count of Participants
2596490|NCT02208089|Primary|Change in LogMAR Corrected Distance Visual Acuity (CDVA)|Change in spectacle corrected logarithm minimum angle of resolution (LogMAR) distance visual acuity recorded in a 4m testing lane in photopic lighting conditions between baseline measurement and final review at 24 months (note that negative change = better vision; 0.1 logMAR units = 1 line on the test chart)|Preoperative vs 24 months||||LogMAR CDVA||Standard Deviation|Mean
2596491|NCT02208063|Secondary|Number of Participants With the Development of a New Metastatic Foci of S. Aureus Infection at Test of Cure (TOC) in the Microbiological All-treated (mAT) Populations|After Day 8, any sign or symptom leading to a subsequent confirmed diagnosis of a new metastatic foci of S. aureus infection|Day 8|One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.|||Participants|||Count of Participants
2596492|NCT02208063|Secondary|Investigator Clinical Response (Success or Failure) at EOT in the Microbiological All-treated (mAT) Population|This efficacy endpoint was determined to be a clinical failure if the subject switched study antibiotic due to lack of clinical response|Up to 8 weeks|One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.|||Participants|||Count of Participants
2596493|NCT02208063|Secondary|Number of Participants With an Investigator Clinical Outcome of Cure at TOC in the Microbiological All-treated (mAT) Population|"The efficacy endpoint of Investigator clinical outcome of cure at the test of cure (TOC) was determined by the following criteria:~Subject alive at TOC~Resolution of all clinical signs and symptoms of the S. aureus infection at TOC (unless explained by a more likely alternative diagnosis)~No evidence of microbiological persistence or relapse~No new foci of metastatic S. aureus infection after Day 8"|Up to 8 weeks|One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.|||Participants|||Count of Participants
2596494|NCT02208063|Primary|Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC)|"The efficacy endpoint of clinical outcome of cure at the test of cure (TOC) was determined by subjects who meet all of the following criteria, as determined by the investigator and adjudicated by the blinded independent efficacy adjudication committee (IEAC).~Alive at TOC~Resolution of all clinical signed and symptoms of the Staphylococcus aureus (S. aureus) infection at TOC~No evidence of microbiological persistence of relapse~No new foci of metastatic S. aureus infection after Day 8"|Up to 8 weeks|One subject enrolled was excluded from all summaries and analyses because the subject was randomized to a higher dose of telavancin (10mg/kg) that the remainder of the subjects.|||Participants|||Count of Participants
2596495|NCT02208037|Secondary|Primary Cause of Death||1 Year Post-transplant||||Participants|||Count of Participants
2596496|NCT02208037|Secondary|Donor Cell Engraftment|Donor cell engraftment will be assessed with donor/recipient chimerism. Chimerism may be evaluated in bone marrow, whole blood, or CD3 fractions. Full donor chimerism is defined as the presence of ≥ 95% of donor cells as a proportion of total cells. Mixed chimerism is defined as the presence of donor cells, as a proportion of total cells, of < 95% but > 5% in the bone marrow or peripheral blood. Full and mixed chimerism will be evidence of donor cell engraftment. Donor cells of ≤ 5% will be considered as graft rejection.|Days 28 and 100 Post-transplant||||Participants|||Count of Participants
2596497|NCT02208037|Secondary|Percentage of Participants With Platelet Recovery|Platelet recovery is defined as the first day of a sustained platelet count >20,000/mm^3 with no platelet transfusion in the preceding seven days.|Days 60 and 100 Post-transplant||||percentage of participants||90% Confidence Interval|Number
2596498|NCT02208037|Secondary|Percentage of Participants With Neutrophil Recovery|Neutrophil recovery is defined as achieving an absolute neutrophil count (ANC) ≥ 500/mm^3 for three consecutive measurements on three different days.|Days 28 and 100 Post-transplant||||percentage of participants||90% Confidence Interval|Number
2596499|NCT02208037|Secondary|Percentage of Participants With Overall Survival||1 Year Post-transplant||||percentage of participants||90% Confidence Interval|Number
2596500|NCT02208037|Secondary|Percentage of Participants With GVHD-free Survival|GVHD-free survival is defined as being alive without previous onset of Grade III-IV acute GVHD or chronic GVHD requiring immunosuppressive therapy.|1 Year Post-transplant||||percentage of participants||90% Confidence Interval|Number
2596501|NCT02208037|Secondary|Percentage of Participants With Disease-free Survival|Disease-free survival is defined as being alive and free of disease relapse or progression.|1 Year Post-transplant||||percentage of participants||90% Confidence Interval|Number
2596503|NCT02208037|Secondary|Percentage of Participants With Disease Relapse or Progression|Relapse is defined by either morphological or cytogenetic evidence of acute leukemia or MDS consistent with pretransplant features, or radiologic evidence of lymphoma. Progression of disease applies to patients with lymphoproliferative diseases (lymphoma or chronic lymphocytic leukemia) not in remission prior to transplantation and is defined as increase in size of prior sites of disease or evidence of new sites of disease.|1 Year Post-transplant||||percentage of participants||90% Confidence Interval|Number
2596504|NCT02208037|Secondary|Percentage of Participants With Chronic GVHD Requiring Immunosupressive Therapy|Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification. This endpoint considers the occurrence of chronic GVHD that necessitated initiation of immunosuppressive therapy for treatment.|1 Year Post-transplant||||percentage of participants||90% Confidence Interval|Number
2596505|NCT02208037|Secondary|Percentage of Participants With Chronic GVHD|Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification.|1 Year Post-transplant||||percentage of participants||90% Confidence Interval|Number
2596506|NCT02208037|Secondary|Percentage of Participants With Grade III-IV Acute GVHD|"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL 1.2-3 mg/dL 2.3.01-6 mg/dL 3.6.01-15.0 mg/dL 4.>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4"|Day 180 Post-transplant||||percentage of participants||90% Confidence Interval|Number
2596507|NCT02208037|Secondary|Percentage of Participants With Grade II-IV Acute GVHD|"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL~2-3 mg/dL~3.01-6 mg/dL~6.01-15.0 mg/dL~>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4"|Day 180 Post-transplant||||percentage of participants||90% Confidence Interval|Number
2596508|NCT02208037|Primary|Percentage of Participants With GVHD/Relapse or Progression-free Survival (GRFS)|GRFS is defined as being free of grade III-IV acute GVHD onset, chronic GVHD onset requiring systemic immunosuppressive therapy, disease relapse or progression, and death from any cause.|1 Year Post-transplant||||percentage of participants||90% Confidence Interval|Number
2596509|NCT02207972|Secondary|Number of Participants Without Angle Adjustments in Space Success|the number of participants with successes without any readjustment of the angle in the space|immediate||||Participants|||Count of Participants
2596510|NCT02207972|Secondary|Number of Participants With Successful First Attempt|The number of participants who had first attempt success to locate the epidural space and midline position|Immediate|Pregnant patients in labor requesting neuraxial analgesia|||Participants|||Count of Participants
2596511|NCT02207972|Primary|Number of Participants With Accurate Epidural Placement|Number of ultrasound guided CSE technique accurately placed epidural needle in the midline position|2 hours||||Participants|||Count of Participants
2596512|NCT02207907|Secondary|Plaque Control (Overall and Interproximal Dental Plaque Scores) Using Turesky Modification of Quigley &Amp; Hein Plaque Index at 6, 12 and 24 Weeks.|The dental examiner used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. The plaque was first disclosed using a dye solution. Participants then rinsed with disclosing solution according to instructions. They had expectorated and rinsed with 10 mL of water for 10 seconds and expectorated again. Plaque was assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Disclosed plaque was scored as follows: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less tan 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth|Baseline, 6,12 and 24 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Mean
2596513|NCT02207907|Secondary|Bleeding Index at 6, 12 and 24 Weeks|The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system to be used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|Baseline, 6, 12 and 24 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Units on a Scale||Standard Error|Mean
2596569|NCT02207569|Primary|Percent Device Success Rate Between 24 and 7 Day|"Percentage of patients with Device Success defined as:~Absence of procedural mortality, AND~Correct positioning of a single Evolut R valve into the proper anatomical location, AND~Absence of patient-prosthesis mismatch, and mean gradient , 20 mm Hg (or peak velocity < 3m/sec, AND~Absence of moderate or severe prosthetic valve regurgitation"|Assessed at 24 hours to seven days post implantation|All subjects implanted with the Evolut R TAV, defined as the Evolut R TAV is placed in the aortic annulus and completely released from the Enveo catheter delivery system|||percentage of overall device success||95% Confidence Interval|Number
2596514|NCT02207907|Secondary|Modified Gingival Index (MGI) at 6 and 12 Weeks.|MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration|Baseline, 6 and 12 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Mean
2596515|NCT02207907|Secondary|Number of Gingival Bleeding Sites at 6 and 12 Weeks.|Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.|Baseline, 6 and 12 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||number of gingival bleeding sites||Standard Error|Mean
2596516|NCT02207907|Primary|Modified Gingival Index (MGI) at 24 Weeks|The Modified Gingival Index (MGI) was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration|Baseline, 24 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Units on a scale||Standard Error|Mean
2596517|NCT02207907|Primary|Number of Gingival Bleeding Sites at 24 Weeks|Number of gingival bleeding sites were measured as bleeding index via a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used to measure bleeding sites is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed. A bleeding site was considered as a BI score of 1 or 2.|Baseline, 24 weeks|Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement.|||number of gingival bleeding sites||Standard Error|Mean
2596518|NCT02207829|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84 (Week 12). Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84 and 85. Baseline trough FEV1 is the mean of the two assessments made -30 and -5 minutes (min) pre-dose on Day 1. Change from baseline was calculated as the trough FEV1 value on Day 85 minus the BL value. Analysis performed using a repeated measures model with covariates of treatment, baseline FEV1, centre group, 24 hour subset flag, Day, Day by baseline and Day by treatment interactions. The least squares mean changes are presented here.|Baseline (BL) and Day 85|Per Protocol(PP) Population(pop): Participants(par) in the Intent-To-Treat pop who did not have a full protocol deviation considered to impact efficacy. Par represent those with data available at time point presented; however, all par. in the PP pop. without missing covariate information and >=1 post BL measurement are included in analysis|||Liter||Standard Error|Least Squares Mean
2596519|NCT02207816|Secondary|Antibody Concentrations Against Against Plasmodium Falciparum Circumsporozoite (Anti-CS)|Antibody concentrations were assessed by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean titers (GMTs). Seropositivity anti-CS antibody cut-off was 0.5 EU/mL for Malaria-055 time points and 1.9 EU/mL for Malaria-076 time points.|At screening, 1 month post Dose 3 (Month 3), 18 months post Dose 3 (Month 20), 1 month post Dose 4 (Month 21), 12 months post Dose 4 (Month 32) (of Malaria-055) and at Years 1, 2 and 3 (of Malaria-076)|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.|||EU/mL||95% Confidence Interval|Geometric Mean
2596520|NCT02207816|Secondary|Number of Subjects With Meningitis SAEs|For the further evaluation of the safety signal of meningitis all the cases occurring during the study were reported as SAE. Meningitis is defined as an SAE coded at lowest level terms code, coded by MedDRA preferred term level as: 'meningitis', 'meningitis haemophilus', 'meningitis meningococcal', 'meningitis salmonella', 'meningitis pneumococcal', 'meningitis staphylococcal', 'meningitis tuberculous', 'meningitis herpes', 'meningitis candida', 'meningitis enterococcal', 'meningitis enteroviral', 'meningitis neonatal', 'meningitis toxoplasmal', 'meningitis mumps', 'meningitis cryptococcal', 'meningitis histoplasma', 'meningitis trypanosomal', 'Neurosyphilis', 'meningitis leptospiral', 'meningitis listeria', 'meningitis in sarcoidosis' (code in preferred term 'cerebral sarcoidosis'), 'meningitis bacterial', 'meningitis viral', 'meningitis aseptic', 'meningitis fungal'.|From Year 0 to Year 3 (Starting January 2014 and ending December 2016)|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.|||Participants|||Count of Participants
2596521|NCT02207816|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Disorders (pIMDs) SAEs|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Regardless of it being considered an AE or an SAE, it should have been reported per the SAE reporting rules.|From Year 0 to Year 3 (Starting January 2014 and ending December 2016)|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.|||Participants|||Count of Participants
2596522|NCT02207816|Secondary|Number of Subjects Reporting Any, Related, Malaria and Fatal Serious Adverse Events (SAEs)|"Malaria SAEs were defined as SAEs coded by MedDRA preferred term level as 'malaria', 'Plasmodium falciparum infection' or 'cerebral malaria. A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. SAEs disclosed in this outcome are any SAEs , fatal SAEs, those that were related to vaccine administration in the primary study MALARIA-055 PRI (110021) and malaria hospitalization."|From Year 0 to Year 3 (Starting January 2014 and ending December 2016)|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.|||Participants|||Count of Participants
2596523|NCT02207816|Secondary|Number of Subjects With Fatal Malaria Meeting Case Definition 2.|Fatal malaria, case definition 2, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' associated with a fatal outcome.|From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.|||Participants|||Count of Participants
2596524|NCT02207816|Secondary|Number of Subjects With Fatal Malaria Meeting Case Definition 1.|Fatal malaria, case definition 1, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' with confirmed positive Plasmodium falciparum asexual parasitemia associated with a fatal outcome (excludes planned admissions for medical investigation/care or elective surgery and trauma).|From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.|||Participants|||Count of Participants
2596525|NCT02207816|Secondary|Number of Subjects With Cerebral Malaria|Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term.|From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.|||Participants|||Count of Participants
2596526|NCT02207816|Secondary|Number of Subjects With Fatal Malaria Meeting Case Definition 2.|Fatal malaria, case definition 2, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' associated with a fatal outcome.|From Year 0 to Year 3 (Starting January 2014 and ending December 2016)|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.|||Participants|||Count of Participants
2596527|NCT02207816|Secondary|Number of Subjects With Fatal Malaria Meeting Case Definition 1.|Fatal malaria, case definition 1, was defined as a SAE report with preferred terms 'malaria', 'plasmodium falciparum infection', 'cerebral malaria' with confirmed positive Plasmodium falciparum asexual parasitemia associated with a fatal outcome (excludes planned admissions for medical investigation/care or elective surgery and trauma).|From Year 0 to Year 3 (Starting January 2014 and ending December 2016)|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.|||Participants|||Count of Participants
2596528|NCT02207816|Secondary|Number of Subjects With Cerebral Malaria Meeting Both Case Definitions.|Cerebral malaria was defined as a positive P. falciparum asexual parasitemia (within -1 to +3 days of admission), accompanied either by the presence of a marker of disease severity (a Blantyre score ≤ 2) or a SAE report with 'cerebral malaria' as preferred term.|From Year 0 to Year 3 (Starting January 2014 and ending December 2016)|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.|||Participants|||Count of Participants
2596529|NCT02207816|Secondary|Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.|Malaria hospitalization, case definition 2, was defined as a hospitalization for which, in the judgment of the principal investigator, Plasmodium falciparum infection was the sole or a major contributing factor to the presentation.|From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076).|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.|||Participants|||Count of Participants
2596895|NCT02203630|Secondary|Number of Times an Anti-arrhythmic Agent is Used||Up to 28 days||||events|||Number
2596530|NCT02207816|Secondary|Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.|Malaria hospitalization, case definition 1, was defined as a medical hospitalization with confirmed positive Plasmodium falciparum asexual parasitemia (excludes planned admissions for medical investigation/care or elective surgery and trauma).|From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.|||Participants|||Count of Participants
2596531|NCT02207816|Secondary|Incidence of Clinical Malaria Meeting Case Definition|Clinical malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia, accompanied by the presence of fever (axillary temperature ≥ 37.5°C) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T). Due to late protocol approvals and retrospective data collection the sites did not collect the data according to protocol and as such the case definition cannot be applied. For the final analysis, specific case definitions based on available data were developed.|From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.|||events per subject-year|||Number
2596532|NCT02207816|Secondary|Incidence of Severe Malaria Meeting Case Definition 2.|Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia < 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).|From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.|||events per person-year|||Number
2596533|NCT02207816|Secondary|Incidence of Severe Malaria Meeting Case Definition 1.|Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia < 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).|From Month 0 (study start of Malaria-055) to Year 3 (study end of Malaria-076)|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received Dose 1 of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment on subjects from both studies.|||events per person-year|||Number
2596534|NCT02207816|Secondary|Number of Subjects With Prevalent Moderate Anemia (Level of Hemoglobin <8g/dL)|Prevalent moderate anemia (PMA) was defined as a documented hemoglobin < 8.0 g/dL, identified at an annual visit.|At Years 1, 2 and 3|The analysis was performed on the modified ITT population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study, with available results at the specified time-points. The analyses on the modified ITT population were performed per treatment assignment.|||Participants|||Count of Participants
2596535|NCT02207816|Secondary|Number of Subjects With Prevalent Severe Anemia (Level of Hemoglobin <5g/dL)|Prevalent severe anemia (PSA) was defined as a documented hemoglobin lower than (<) 5.0 grams per deciliter (g/dL), identified at an annual visit.|At Years 1, 2 and 3|The analysis was performed on the modified ITT population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study, with available results at the specified time-points. The analyses on the modified ITT population were performed per treatment assignment.|||Participants|||Count of Participants
2596536|NCT02207816|Secondary|Number of Subjects With Prevalent Parasitemia|Prevalent parasitemia (PP) was defined as a documented Plasmodium falciparum asexual parasite density greater than (>) 0 parasites/µL, identified at an annual visit.|At Years 1, 2 and 3|The analysis was performed on the modified ITT population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study, with available results at the specified time-points. The analyses on the modified ITT population were performed per treatment assignment|||Participants|||Count of Participants
2596537|NCT02207816|Secondary|Number of Subjects With Malaria Hospitalization Meeting Case Definition 2.|Malaria hospitalization, case definition 2, was defined as a hospitalization for which, in the judgment of the principal investigator, Plasmodium falciparum infection was the sole or a major contributing factor to the presentation.|From Year 0 to Year 3 (Starting January 2014 and ending December 2016)|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.|||Participants|||Count of Participants
2596896|NCT02203630|Secondary|Number of Uses of Rate-controlling Agent|includes use of Diltiazem, Esmolol, Metoprolol, Propranolol, Verapamil|Up to 28 days||||number of uses|||Number
2596538|NCT02207816|Secondary|Number of Subjects With Malaria Hospitalization Meeting Case Definition 1.|Malaria hospitalization, case definition 1, was defined as a medical hospitalization with confirmed positive Plasmodium falciparum asexual parasitemia (excludes planned admissions for medical investigation/care or elective surgery and trauma).|From Year 0 to Year 3 (Starting January 2014 and ending December 2016)|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.|||Participants|||Count of Participants
2596539|NCT02207816|Secondary|Incidence of Clinical Malaria Meeting Case Definition|Clinical malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia, accompanied by the presence of fever (axillary temperature ≥ 37.5°C ) at the time of presentation or history of fever within 24 hours of presentation and occurring in a child who was unwell and brought for treatment to a healthcare facility. The incidence of clinical malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years a t risk (T). Due to late protocol approvals and retrospective data collection the sites did not collect the data according to protocol and as such the case definition cannot be applied. For the final analysis, specific case definitions based on available data were developed.|From Year 0 to Year 3 (Starting January 2014 and ending December 2016)|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.|||events per person-year|||Number
2596540|NCT02207816|Primary|Incidence of Severe Malaria Meeting Case Definition 2.|Case definition 2 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia < 5.0 grams per deciliter (g/dL) or SAE report including preferred terms (Malaria, Plasmodium falciparum infection or Cerebral malaria) within -1 to +3 days of admission. The incidence of severe malaria for case definition 2 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).|From Year 0 to Year 3 (Starting January 2014 and ending December 2016)|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.|||events per person-year|||Number
2596541|NCT02207816|Primary|Incidence of Severe Malaria Meeting Case Definition 1|Case definition 1 for severe malaria was defined as an episode of malaria with positive Plasmodium falciparum asexual parasitemia (within -1 to +3 days of admission) and with one or more marker of disease severity: Prostration, respiratory distress, Blantyre score equal to or less than (≤) 2, seizures 2 or more, hypoglycemia below (<) 2.2 millimoles per liter (mmol/L), acidosis BE ≤ -10.0 mmol/L, lactate ≥ 5.0 mmol/L or anemia < 5.0 grams per deciliter (g/dL). The incidence of severe malaria for case definition 1 is expressed as a person year rate for each group (n/T), representing the number of events (n) reported over the risk period, which was counted in days and expressed as person years at risk (T).|From Year 0 to Year 3 (Starting January 2014 and ending December 2016)|The analysis was performed on the modified Intention-to-Treat (ITT) population, which included all subjects that consented to the trial and received at least 1 dose of the corresponding study vaccine in Malaria-055 (NCT00866619) study. The analyses on the modified ITT population were performed per treatment assignment.|||events per person-year|||Number
2596542|NCT02207803|Secondary|Exemplary Care Scale-Provide Subscale|4-item measure of the patient's report of the quality of care they receive from their caregiver. Response options for each item range from 1-4, and total scores range from 4-16, with higher scores indicating a higher quality of informal care received. Only Provide subscale scores of the Exemplary Care Scale are reported here.|2 months post-hospital discharge|This is patient-report only at post-test, hence it does not use the full sample.|||units on a scale||Standard Deviation|Mean
2596543|NCT02207803|Primary|Zarit Burden Interview|22-item measure of caregiver self-reported burden. Response options for each item range from 0-4, and total scores range from 0-88, with higher scores indicating greater self-reported burden. Only total scores are reported here.|2 months post-hospital discharge|Data are from caregivers only, hence not the full sample.|||units on a scale||Standard Deviation|Mean
2596544|NCT02207725|Secondary|Efficacy: Number of Participants With Thrombin Generation (ETP) Above the Lower Limit of the Derived Normal Range at Its Peak (mITT Population)|Number of participants with ETP above the lower limit of the normal range at its peak, between the +2 minute time point and the +10 minute time point after the end of the andexanet bolus (inclusive) [Part I] or between the 110-minute time point (10 minutes prior to the end of the continuous infusion) and the 5-minute time point after the end of the continuous infusion (inclusive) [Part II]. ETP was measured using a tissue factor-initiated thrombin generation assay|Baseline to +2 minutes or +10 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II)|33 and 31 subjects who received andexanet or placebo were included in the PD analysis in Part I and II, respectively; mITT population|||Participants|||Count of Participants
2596580|NCT02207530|Secondary|Disease Control at 6 Months|"Disease control (DCR) at 6 months based on BICR assessments according to RECIST v1.1.~DCR at 6 months was evaluated using 2 different approaches to the length of stable disease (SD):~Method 1: Patients who had a best objective response of complete response (CR) or partial response (PR) within 24 weeks or had demonstrated SD for a minimum interval of 24 weeks following the start of study treatment.~Method 2: Patients who had a best objective response of CR or PR within 24 weeks or had demonstrated SD for a minimum interval of 16 weeks following the start of study treatment."|6 months|Evaluable analysis set - included all patients who received at least one dose of study treatment who had a baseline tumor assessment and had measurable disease at baseline according to BICR.|||% of participants|||Number
2596545|NCT02207725|Secondary|Efficacy: Change in Thrombin Generation (ETP) From Baseline to Its Peak [Parts I and II]|Change in ETP from baseline to its peak, where peak was defined as the largest value for ETP between the +2 minute time point and the +10 minute time point after the end of the andexanet bolus (inclusive) {Part I] or between the 110-minute time point (10 minutes prior to the end of the continuous infusion) and the 5-minute time point after the end of the continuous infusion (inclusive) [Part II]. Baseline was the last assessment obtained prior to the first dose of andexanet or placebo. ETP was measured using a tissue factor-initiated thrombin generation assay.|Baseline to +2 minutes or +10 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II)|33 and 31 subjects who received andexanet or placebo were included in the PD analysis in Part I and II, respectively; mITT population|||nmol/min||Standard Deviation|Mean
2596546|NCT02207725|Secondary|Efficacy -Change From Baseline in Free Apixaban Concentration at the Nadir|Change from baseline in free apixaban concentration (ng/mL) at the nadir, when nadir was defined as the smaller value for free apixaban at the +2 minute or +5 minute time point after the completion of the andexanet bolus (Part I) or between the 110-minute time point (10 minutes prior to the end of the continuous infusion) and the 5-minute time point after the end of the continuous infusion (inclusive) [Part II]. Free plasma concentrations of apixaban was determined using a validated method that involved analysis of citrated human plasma with high-throughput equilibrium dialysis followed by liquid chromatography mass spectrometry.|Baseline to +2 minutes or +5 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II)|54 subjects who received apixaban were included in the apixaban pharmacokinetics (PK) analysis|||ng/mL||Standard Deviation|Mean
2596547|NCT02207725|Secondary|Efficacy: Number of Participants With ≥80% Reduction in the Anti-fXa Activity From Baseline to Nadir|Occurrence of ≥80% reduction in anti-fXa activity from its baseline to nadir, when nadir was defined as the smaller value for anti-fXa activity at the +2 minute or +5 minute time point after the completion of the andexanet bolus (Part I) or between the 110-minute time point (10 minutes prior to the end of the continuous infusion) and the 5-minute time point after the end of the continuous infusion (inclusive) [Part II]. Baseline was the last assessment obtained prior to the first dose of andexanet or placebo|Baseline to +2 minutes or +5 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II)|mITT; 33 and 31 subjects who received andexanet or placebo were included in the pharmacodynamics (PD) analysis in Part I and II, respectively.|||Participants|||Count of Participants
2596548|NCT02207725|Secondary|Efficacy: Percent Change From Baseline in Anti-fXa Activity at the Nadir (Part II)|The percent change from baseline in anti-fXa activity at the nadir, following the bolus, when nadir was defined as the smaller value for anti-fXa activity at the +2 minute or +5 minute time point after the completion of the andexanet bolus (Part II). Baseline was the last assessment obtained prior to the first dose of andexanet or placebo|Baseline to +2 minutes or +5 minutes following the end of andexanet/placebo bolus (Part II)|mITT; 33 and 31 subjects who received andexanet or placebo were included in the PD analysis in Part I and II, respectively.|||Percent change in anti-fXa activity||Standard Deviation|Mean
2596549|NCT02207725|Primary|Efficacy: Percent Change From Baseline in Anti-fXa Activity at the Nadir (Parts I and II)|In Part I, the primary endpoint was percent change from baseline in anti-fXa activity at the nadir, when nadir was defined as the smaller value for anti-fXa activity at the +2 minutes or +5 minutes time point following the end of the bolus. In Part II, the primary endpoint was the percent change from baseline in anti-fXa activity from its baseline to nadir, when nadir was defined as the smaller value for anti-fXa activity between the 110-minute time point (10 minutes prior to the end of the continuous infusion) and the 5-minute time point after the end of the continuous infusion. The baseline for the primary endpoint in both parts was the anti-fXa activity just prior to administration of andexanet, 3 hours following the Day 4 dose of apixaban. Anti-fXa activity was measured by a modified chromogenic assay.|Baseline to +2 minutes or +5 minutes following the end of andexanet/placebo bolus (Part I), or 10 minutes prior to end of andexanet/placebo continuous infusion or 5 minutes after the end of andexanet/placebo continuous infusion (Part II)|Modified Intent-to-Treat Population included all subjects receiving andexanet/placebo with anti-fXa activity baseline value at ≥1 timepoints: 2 or 5 minute after the end of the bolus (Part I; N = 33); 110 minute during continuous infusion, 2 minute before or 5 minute after the end of continuous infusion (Part II; N = 31).|||Percent change in anti-fXa activity||Standard Deviation|Mean
2596550|NCT02207634|Secondary|Mean Change From Baseline in Reaction Time (RTI) Median 5-choice Reaction Time Z Score|Assessments were performed with the CANTAB, a language-independent battery of computerized tests that is used to assess cognitive function. The Reaction Time (RTI) test assessed the cognitive domain of psychomotor speed (detecting and responding to a stimulus). Participants held down a button until a spot appeared in 1 of 5 circles on the screen. As soon as possible after the spot flashed up, the patient lifted their finger from the button and touched the circle in which the spot appeared. The RTI median 5-choice reaction time was the median duration between the onset of the stimulus and the release of the button. Z score represents the standardized measure of how far an individual participant deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported.|Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).|"All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.~Cognitive function assessments after an on-study stroke event were excluded from the analysis."|||Z score||95% Confidence Interval|Least Squares Mean
2596581|NCT02207530|Secondary|Time to Onset of Response From First Dose|Time to onset of response in patients with objective response based on BICR assessments according to RECIST 1.1|12 months|Evaluable analysis set - included all patients who received at least one dose of study treatment who had a baseline tumor assessment and had measurable disease at baseline according to BICR.|||Months||Full Range|Median
2596653|NCT02207322|Secondary|Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at Week-2|compare PHQ-9 score at week-2 between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression|week 2||||units on a scale||95% Confidence Interval|Mean
2596551|NCT02207634|Secondary|Mean Change From Baseline in Paired Associated Learning (PAL) Total Errors Adjusted Z Score|"The CANTAB PAL test assesses visuospatial episodic memory (storing/retrieving information by associating an event with a time and place). Boxes on the screen opened up one at a time to reveal a number of patterns. Participants were asked to remember the location of each pattern. After all the boxes had been opened, each pattern was then shown in the center of the screen in a randomized order, and the patient should touch the box where they think each pattern was hidden. The PAL total errors adjusted comprised the number of errors committed by a patient plus an adjustment for the estimated number of errors the patient would have made on any stages that were not reached.~Z score represents the standardized measure of how far an individual patient deviates from the study cohort average at baseline. A higher Z score indicated better performance. The mean change from baseline averaged across all the visits is reported."|Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).|"All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.~Cognitive function assessments after an on-study stroke event were excluded from the analysis."|||Z score||95% Confidence Interval|Least Squares Mean
2596552|NCT02207634|Secondary|Mean Change From Baseline in Spatial Working Memory (SWM) Between-errors Z Score|"Assessments were performed with the CANTAB, a language-independent battery of computerized tests that is used to assess cognitive function. The Spatial Working Memory (SWM) between-errors test assesses the cognitive domain of working memory (holding material in mind while that material is being actively processed). Patients search for colored tokens hidden inside boxes on the screen by touching them. The critical instruction is that once a token has been found inside a box, there will never be a token hidden inside that box again, so patients must not return to a box where a token has been found.~The SWM between-errors score is the number of times that a patient revisited a box in which a token had previously been found. The Z score represents the standardized measure of how far an individual participant deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported."|Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).|"All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.~Cognitive function assessments after an on-study stroke event were excluded from the analysis."|||Z score||95% Confidence Interval|Least Squares Mean
2596553|NCT02207634|Primary|Mean Change From Baseline in Spatial Working Memory Strategy Index of Executive Function (6-8 Boxes) Z Score|"Assessments were performed with the Cambridge Neuropsychological Test Automated Battery (CANTAB), a language-independent battery of computerized tests that is used to assess cognitive function.~The Spatial Working Memory (SWM) test assesses the cognitive domain of executive function (high-level thinking and decision making). Patients search for colored tokens hidden inside boxes on the screen by touching them. The critical instruction is that once a token has been found inside a box, there will never be a token hidden inside that box again, so patients must not return to a box where a token has been found.~The SWM strategy index of executive function represented the number of times a subject began a search with a different box. The Z score represents the standardized measure of how far an individual subject deviates from the study cohort average at baseline. A higher Z score reflects better performance. The mean change from baseline averaged across all the visits is reported."|Assessments were conducted at Baseline and at weeks 24, 48, 96, 144 and end of study visit (median time on study was 19.4 months).|"All enrolled and dosed participants who completed a baseline cognitive functional assessment prior to or on the first date of administration of study drug and who have at least one post-baseline cognitive measure.~Cognitive function assessments after an on-study stroke event were excluded from the analysis."|||Z score||95% Confidence Interval|Least Squares Mean
2596554|NCT02207621|Secondary|Extent of Exposure|Exposure to study medication in days for all treatment groups|12 Months|The Safety Population included all randomized subjects who received at least 1 dose of study medication and was used to summarize safety variables. The safety population summarized subjects as treated for purpose of analysis. One (1) subject did not receive study drug as randomized, shown in the Participant Flow|||days||Standard Deviation|Mean
2596555|NCT02207621|Primary|Intraocular Pressure (IOP)|The primary efficacy outcome is mean intraocular pressure (IOP)|3 months|The Per Protocol (PP) population includes all subjects who did not have a major protocol violation likely to seriously affect the primary outcome of the study. This is the primary population for efficacy analyses.|||mmHg||Standard Deviation|Mean
2596556|NCT02207608|Primary|Visual Analogue Scale for Pain|1 to 10 scale (1 minimum pain perceivable; 10 unbearable pain, as perceived by the patient)|Before and after six weeks of treatment (end of induction course)||||units on a scale||Standard Deviation|Mean
2596557|NCT02207569|Secondary|Hemodynamic Performance: Total Prosthetic Valve Regurgitation Graded as Moderate or Severe|Hemodynamic performance: the percent of patients who have a degree of total prosthetic valve regurgitation that is moderate or severe.|Assessed at 30 days, 6 months, and 1 year|The hemodynamic performance subset includes all subjects implanted with the Evolut R TAV for more than 24 hours post implantation. Only subjects with echo can be analyzed.|||percentage of participants|||Number
2596558|NCT02207569|Secondary|Hemodynamic Performance - Aortic Valve Area|Hemodynamic performance by Doppler echocardiography - Aortic Valve Area cm2|Assessed at baseline, 30 days, 6 months, and 1 year|The hemodynamic performance subset includes all subjects implanted with the Evolut R TAV for more than 24 hours post implantation - only subjects with echo can be analyzed.|||cm²||Standard Deviation|Mean
2596582|NCT02207530|Secondary|Duration of Response|"Duration of objective response in patients with objective response based on BICR assessments according to RECIST v1.1.~Duration of response was the time from the first documentation of complete or partial response until the date of progression (which was subsequently confirmed), death, or the last evaluable RECIST assessment for patients that did not progress.~An ongoing response was defined as a patient who had documented objective response and was still alive and progression-free at the time of the data cut-off."|12 months|Evaluable analysis set - included all patients who received at least one dose of study treatment who had a baseline tumor assessment and had measurable disease at baseline according to BICR.|||Participants|||Number
2596559|NCT02207569|Secondary|Major Vascular Complication|"Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm OR~>~Access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure) leading to death, life-threatening or major bleeding, visceral ischemia, or neurological impairment OR~>~Distal embolization (noncerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage OR~>~The use of unplanned endovascular or surgery associated with death, major bleeding, visceral ischemia or neurological impairment OR~>~Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram OR~>~Surgery for access site nerve injury OR~>~Permanent access related nerve injury"|Assessed at 30 days post-implantation|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the Evolut R system.|||percentage of participants||95% Confidence Interval|Number
2596560|NCT02207569|Secondary|Hemodynamic Performance -Mean Gradient|Mean gradient by Doppler echocardiography.|Assessed at baseline, 30 days, 6 months, and 1 year|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the Evolut R system. Only subjects with echo can be analyzed.|||mmHg||Standard Deviation|Mean
2596561|NCT02207569|Secondary|Percent Resheath and Recapture Success Rate|Resheath or recapture success rate (where attempted) where a successful resheath is defined as the intended portion of the Evolut R is resheathed into the capsule of the delivery catheter to the intended amount, as verified by flouroscopy; and a successful recapture is defined as the entire Evolut R TAV (including the frame) is full resheathed into the capsule of the delivery catheter until there is no gap between the capsule and the tip , as verified by flouroscopy. Resheath or recapture wa attempted in a subset of patients. Success rate is calculated as successful resheath or recaputure events in the number of total events. Resheath anad recapture is only possible during the index procedure.|Assessed intra-procedurally|65 patients had resheath or recapture feature used during the 241 attempted procedures.|||percentage of resheath or recapture|||Number
2596562|NCT02207569|Secondary|Percent Rate of Patients Who Received New Permanent Pacemaker Implant at 30 Days|Percent of patients who underwent implantation of new permanent pacemaker or ICD during or after index procedure|Assessed at 30 days|All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed. Additionally, these patients did NOT have ICD or PPM at the time of the index procedure.|||percentage of participants||95% Confidence Interval|Number
2596563|NCT02207569|Secondary|Percentage of Patients With Life-threatening or Disabling Bleeding Event Rate|"Fatal bleeding (BARC type 5) OR~>~Bleeding in a critical organs, such as intracranial, intraspinal,~> intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR~>~Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR~>~Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units* > (BARC type 3b)"|Assessed at 30 days post-implantation|All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.|||percentage of participants||95% Confidence Interval|Number
2596564|NCT02207569|Secondary|Percent of Patients With Acute Kidney Injury: Stage 2 or 3 (Including Renal Replacement Therapy).|"Stage 2~Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR~>~Urine output <0.5 mL/kg/h for >12 but <24 h > Stage 3 >~1) Increase in serum creatinine to ≥300% (>3 x increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR~Urine output <0.3 ml/kg/h for ≥24 h OR~>~Anuria for ≥12 h"|Assessed at 30 days post-implantation|All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.|||percentage of participants||95% Confidence Interval|Number
2596565|NCT02207569|Secondary|Percent VARC II Combined Safety Endpoint at 30 Days|"VARC II composite safety endpoint rate includes percent freedom from the following components:~All-cause mortality~All stroke (disabling and non-disabling)~Life-threatening bleeding~Acute kidney injury: stage 2 or 3 (including renal replacement therapy).~Coronary artery obstruction requiring intervention.~Major vascular complication.~Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)"|Assessed at 30 days post-implantation|All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.|||percentage of participants||95% Confidence Interval|Number
2596566|NCT02207569|Secondary|Coronary Artery Obstruction Requiring Intervention.|Angiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the Evolut R prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVI procedure.|Assessed at 30 days post-implantation|All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.|||percentage of participants||95% Confidence Interval|Number
2596567|NCT02207569|Secondary|Individual Component of VARC II Safety Endpoint: Percentage of People Requiring Valve-related Dysfunction Requiring Repeat Procedure (BAV, TAVI, or SAVR)|Percentage of patients with any valve dysfunction that requires repeat procedure (e.g. balloon valvuloplasty, TAVI, or surgical AVR), per VARC II definition.|Assessed at 30 days post-implantation|The safety subset includes all subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, or any monitoring line placed.|||percentage of overall patients||95% Confidence Interval|Number
2596568|NCT02207569|Primary|Percentage of Patients With Less Than Moderate Prosthetic Regurgitation at Early Post Procedure Echocardiogram (24 Hours to 7 Days)|Percentage of patience with none, trace or mild total prosthetic regurgitation at early post procedure echo cardiogram (24 hours to 7 days) as evaluated by echo core lab.|Assessed at 24 hours to 7 days post implantation|Subset includes all subjects who are implanted with the Evolut R TAV, defined as the Evolut R TAV is placed in the aortic annulus and completely released from the Enveo catheter delivery system|||percentage of partcipants||95% Confidence Interval|Number
2596570|NCT02207569|Primary|Percentage of Patients With Disabling Stroke at 30 Days|"Stroke Diagnostic Criteria:~>~Acute episode of focal or global neurological deficit with at least 2 of the following:~change in level of consciousness >~hemiplegia, hemiparesis~numbness or sensory loss affecting 1 side >~dysphasia or aphasia~hemianopia~amaurosis fugax >~other neurological signs or symptoms consistent with stroke~2.) No other readily identifiable non-stroke cause or the clinical presentation, to be determined by or in conjunctions with the designated neurologist~3.) Confirmation of the diagnosis by at least 1 of the following:~Neurological specialist >~Neuroimaging procedure, or on clincial grounds alone > Stroke: durations of neural deficit > 24 h if available neuroimaging documents a new hemofrrhage or infarct; or the neurological deficit results in death~Defined by VARC II:~> An mRS (Modified Rankin Score) of 2 or more at 90 days and an increase in at least 1 mRS category from pre-stroke baseline"|Assessed at 30 days post-implantation|All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.|||percentage of participants||95% Confidence Interval|Number
2596571|NCT02207569|Primary|All-cause Mortality at 30 Days by Percent|Percentage of patients that died by any cause at 30 days|Assessed at 30 days post-implantation|All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.|||percentage of partcipants||95% Confidence Interval|Number
2596572|NCT02207556|Secondary|Patient-reported Mental Quality of Life|"We will collect patient-reported health quality of life in this study.~Subjects will complete the Patient Reported Outcomes Measurement Information System Global Health instrument, a 10-item standardized patient-reported outcome measure that provides global ratings of physical function, fatigue, pain, emotional distress to report on common domains of health-related quality of life. The survey comprises a series of 5- or 10-response Likert-style questions. For each question, a low score indicates lesser or absent symptom or feeling and higher indicates more severe symptom or feeling. Summing the individual item scores determines the overall score."|Baseline, 3, 6, 9 and 12 months|||||||
2596573|NCT02207556|Secondary|Patient-reported Health Quality of Life|Subjects will complete the Patient Reported Outcomes Measurement Information System Global Health instrument, a 10-item standardized patient-reported outcome measure that provides global ratings of physical function, fatigue, pain, emotional distress to report on common domains of health-related quality of life. The survey comprises a series of 5- or 10-response Likert-style questions. For each question, a low score indicates lesser or absent symptom or condition and higher indicates more severe symptom or condition. Summing the individual item scores determines the overall score.|Baseline, 3, 6, 9 and 12 months|||||||
2596574|NCT02207556|Secondary|Mortality|The number of living subjects will be determined at 1 month, 6 months and 1 year|1 month, 6 months, 1 year|||||||
2596575|NCT02207556|Secondary|Amyloid Organ Response|"This measure will record the number of subjects for each grade of response to therapy. Efficacy will be measured by amyloid organ response in heart, liver, or kidney, as appropriate, at 6 and 1 year.~Heart~N-terminal (NT)-proBNP response >30% and > 300 ng/L decrease in patients with baseline NT-proBNP ≥650 ng/L (Patients with progressively worsening renal function cannot be scored for NT-proBNP progression).~Improvement by 2 New York Heart Association (NYHA) classes without an increase in diuretic use or in echocardiographic wall thickness.~≥ 2 mm reduction in the interventricular septal thickness by echocardiogram or Improvement of ejection fraction by ≥20%.~Liver~≥50% decrease in an initially elevated alkaline phosphatase level, or Decrease in liver size by at least 2 cm by ultrasound.~Kidney~50% reduction in 24-hour urine protein excretion (at least 0.5 g/day) without worsening of creatinine or creatinine clearance by 25% over baseline."|6 months and 1 year||2019-12-31|12/2019||||
2596576|NCT02207556|Primary|Hematologic Response|"This measure will record the number of subjects for each grade of response to therapy for subjects with Systematic Disease (hematologic) only. Hematologic response will be determined as follows.~Complete response (CR) - Negative serum/urine immunofixation with normal Free Light Chain (FLC) ratio~Very Good Partial Response (VGPR)- Difference between involved and uninvolved FLCs (dFLC) < 40 mg/L~Partial Response (PR)- dFLC decrease > 50%~No Response (NR)- less then PR."|1 year|Hematologic response is not relevant to subjects with localized disease. Subjects with localized disease were not included in this analysis.|||Participants|||Count of Participants
2596577|NCT02207530|Secondary|Quality of Life|"Improvement in quality of life was assessed using European Organisation for Research and Treatment of Cancer (EORTC) questionnaires:~The impact of treatment on Health-Related Quality of Life, functioning, and symptoms was evaluated using the EORTC QLQ-C30 v3.~Head and neck cancer-specific symptoms were evaluated using the EORTC QLQ-H&N35.~Function or global health status/quality of life improvement was defined as patients with 2 consecutive assessments at least 14 days apart that showed a clinically meaningful improvement (an increase from baseline score ≥10). Symptom improvement was defined as 2 consecutive assessments at least 14 days apart that showed a clinically meaningful improvement (a decrease from baseline score ≥10).~Scale improvement was defined as patients with 2 consecutive assessments at least 14 days apart that showed a clinically meaningful improvement (a decrease from baseline score ≥10)."|12 months|Full analysis set - included all treated patients who had a baseline tumor assessment and had measurable disease at baseline according to the Investigator site assessment.|||% of participants||95% Confidence Interval|Number
2596578|NCT02207530|Secondary|Overall Survival (OS)|Survival status at time of overall survival analysis. 'Still in survival follow-up' includes patients known to be alive at data cut-off. 'Terminated prior to death' includes patients with unknown survival status, or who were lost to follow-up.|12 months|Full analysis set - included all treated patients who had a baseline tumor assessment and had measurable disease at baseline according to the Investigator site assessment.|||% of participants|||Number
2596579|NCT02207530|Secondary|Progression-free Survival|"Progression status based on BICR assessments according to RECIST v1.1 at time of PFS analysis.~Progression was defined as the time from the date of first dose until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdrew from therapy or received another anti-cancer therapy prior to progression."|12 months|Full analysis set - included all treated patients who had a baseline tumor assessment and had measurable disease at baseline according to the Investigator site assessment.|||% of participants|||Number
2597522|NCT02196714|Primary|CL/F|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||L/h||Full Range|Mean
2596583|NCT02207530|Secondary|Duration of Response- Participants Remaining in Response|"Participants remaining in response - based on BICR assessments according to RECIST v1.1.~An ongoing response was defined as a patient who had documented objective response and was still alive and progression-free at the time of the data cut-off."|12 months|Evaluable analysis set - included all patients who received at least one dose of study treatment who had a baseline tumor assessment and had measurable disease at baseline according to BICR.|||% of participants|||Number
2596584|NCT02207530|Secondary|Best Objective Response|"Best objective response based on BICR assessments according to RECIST v1.1. Response required confirmation after 4 weeks.~Unconfirmed complete (CR) or partial response (PR) refers to CR or PR achieved but either no confirmation assessment was performed or a confirmation assessment was performed but response was not confirmed."|12 months|Evaluable analysis set - included all patients who received at least one dose of study treatment who had a baseline tumor assessment and had measurable disease at baseline according to BICR.|||% of participants|||Number
2596585|NCT02207530|Primary|Objective Response Rate (ORR)|"Objective response rate (per RECIST 1.1 as assessed by blinded independent central review [BICR]) is defined as the number (%) of patients with a confirmed complete response or confirmed partial response and will be based on all treated patients who are PD-L1-positive with measurable disease at baseline per BICR.~Response Evaluation Criteria in Solid Tumors [RECIST] 1.1. criteria are: Complete response [CR] = disappearance of all target lesions since baseline; and partial response [PR] = at least a 30% decrease in the sum of the diameters of target lesions."|12 months|Evaluable analysis set - all patients who received at least one dose of study treatment, who had a baseline tumor assessment, and had measurable disease at baseline according to BICR|||% of participants||95% Confidence Interval|Number
2596586|NCT02207491|Secondary|Extent of Exposure|Exposure to study medication in days for all treatment groups.|3 months|Safety Population: all randomized subjects who received at least 1 dose of study medication. The safety population summarizes subjects as treated for purpose of analysis. Three (3) subjects received incorrect study medication from that to which they were randomized, shown in the Participant Flow.|||days||Standard Deviation|Mean
2596587|NCT02207491|Primary|Intraocular Pressure (IOP)|The primary efficacy outcome is mean IOP|3 months|Per-Protocol (PP) Population. The PP population includes subjects who did not have major protocol violations likely to seriously affect the primary outcome of the study. The PP population summarizes subjects as treated for purpose of analysis.|||mmHg||Standard Deviation|Mean
2596588|NCT02207478|Secondary|The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone|Including total procedure time，total X-ray time, duration time for finding lesions and X-ray time for finding lesions.|Up to half year||||seconds||Standard Deviation|Mean
2596589|NCT02207478|Primary|The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB|The diagnostic yield in the ENB-GS-TBLB and GS-TBLB group was 87.2% and 61% individually.|Up to half year||||participants|||Number
2596590|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months, Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period [approximately 28 days (primed subjects) and 56 days (unprimed subjects)]|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Subjects|||Number
2596591|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination.|During the 28-day (Days 0-27) follow-up period after vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Subjects|||Number
2596592|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting the Occurrence of All Medically Attended Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was a MAE that prevented normal activities. Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.|During the entire study period (approximately 28 days (primed subjects) and 56 days (unprimed subjects) following vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Subjects|||Number
2596593|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms.|Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any = occurrence of any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 = ORS symptoms that prevented normal activities. Related = ORS symptom assessed by the investigator as causally related to the vaccination.|During a 3 day (Days 0-2) follow-up period after vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Subjects|||Number
2596654|NCT02207322|Secondary|Anxiety Symptoms at 6 Months Using the Hospital Anxiety and Depression Scale (HADS)|compare anxiety symptoms using HADS at 6 months adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms|6 months||||units on a scale||95% Confidence Interval|Mean
2596594|NCT02207413|Secondary|Duration of Solicited General AEs in Subjects Aged 6-35 Months.|Duration was defined as number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Days||Full Range|Median
2596595|NCT02207413|Secondary|Duration of Solicited Local AEs in Subjects Aged 6-35 Months.|Duration was defined as number of days with any grade of local symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Days||Full Range|Median
2596596|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>)39.0°C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Subjects|||Number
2596597|NCT02207413|Secondary|Number of Subjects Aged 6 Months to <5 Years, Reporting Fever ≥38ºC (100.4°F) and >39.0°C (102.2ºF) Across Doses.|"Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever = temperature above 39.0°C/102.2ºF.~Data of 2 independent groups were pooled."|During the 2 days (Day 0-Day 1) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 months to <5 years, with at least one vaccine administration documented.|||Subjects|||Number
2596598|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs).|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. > 50mm.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Subjects|||Number
2596599|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2.|"Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period.~Fever = temperature of ≥ 38°C/100.4°F by any route"|During 7 days (Days 0-6) post-vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Subjects|||Number
2596600|NCT02207413|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months.|MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available|||Fold increase||95% Confidence Interval|Geometric Mean
2596601|NCT02207413|Secondary|Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available|||Subjects|||Number
2596602|NCT02207413|Secondary|Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available|||Subjects|||Number
2596645|NCT02207322|Other Pre-specified|Caregiver Quality of Life|we will use the CareGiver Oncology QOL questionnaire (CarGOQOL) to compare caregiver QOL at week-2 between the study arms caregiver quality of life score ranges from 0-120 with higher scores indicating better caregiver quality of life|week-2||||units on a scale||95% Confidence Interval|Mean
2597523|NCT02196714|Primary|CL/F|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||L/h||Full Range|Mean
2596603|NCT02207413|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available|||Titers||95% Confidence Interval|Geometric Mean
2596604|NCT02207413|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years.|MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available|||Fold increase||95% Confidence Interval|Geometric Mean
2596605|NCT02207413|Secondary|Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available|||Subjects|||Number
2596606|NCT02207413|Secondary|Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available|||Subjects|||Number
2596607|NCT02207413|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 28 post last vaccination|The analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were avail|||Titers||95% Confidence Interval|Geometric Mean
2596608|NCT02207413|Secondary|Number of Subjects Aged 5-17 Years Reporting Myalgia Across Doses.|Any = occurrence of any myalgia symptom regardless of intensity grade or relationship to vaccination.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented.|||Subjects|||Number
2596609|NCT02207413|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years.|"MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0).~The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria)."|At Day 21|The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2596610|NCT02207413|Secondary|Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|"A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.~The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria)."|At Day 0 and Day 21|The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Subjects|||Number
2596646|NCT02207322|Secondary|Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 6 Months|Compare patient-reported Post-Traumatic Stress Disorder (PTSD) as measured by the PTSD checklist at 6 months PTSD score ranges from 17-85 with higher scores indicating higher PTSD symptoms|6-months||||units on a scale||95% Confidence Interval|Mean
2596773|NCT02204748|Primary|Femoro-tibial Kinematics - Translation and Lift-off for Deep Knee Bend|Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.|3 months post-operative||||mm||Standard Deviation|Mean
2596611|NCT02207413|Secondary|Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|"A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.~The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria)."|At Day 21|The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Subjects|||Number
2596612|NCT02207413|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 0 and Day 21|The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2596613|NCT02207413|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.|HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 to 35 months, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available|||Titers||95% Confidence Interval|Geometric Mean
2596614|NCT02207413|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.|HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).|At Day 28 post last vaccination|Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available|||Titers||95% Confidence Interval|Geometric Mean
2596615|NCT02207413|Primary|Number of Subjects Aged 3-17 Years, Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period [approximately 28 days (primed subjects) and 56 days (unprimed subjects)]|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.|||Subjects|||Number
2596616|NCT02207413|Primary|Number of Subjects Aged 18-49 Years, Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (approximately 21 days)|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.|||Subjects|||Number
2596617|NCT02207413|Primary|Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC Across Doses.|Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period.|During 7 days (Days 0-6) post-vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.|||Subjects|||Number
2596618|NCT02207413|Primary|Number of Subjects Aged 3-17 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 28-day (Days 0-27) follow-up period after vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 months to 17 years, with at least one vaccine administration documented.|||Subjects|||Number
2596647|NCT02207322|Secondary|Patient-reported Post-Traumatic Stress Disorder (PTSD) as Measured by the PTSD Checklist at 3 Months|Compare patient-reported Post-Traumatic Stress Disorder (PTSD) as measured by the PTSD checklist at 3 months PTSD score ranges from 17-85 with higher scores indicating higher PTSD symptoms|3-months||||units on a scale||95% Confidence Interval|Mean
2596648|NCT02207322|Secondary|Symptom Burden (as Measured by the Edmonton Symptom Assessment Scale) at Week-2|compare symptom burden as measured by Edmonton Symptom Assessment Scale at week-2 adjusting for baseline scores Symptoms burden range is from 0-90 with higher scores indicating higher symptom burden|week-2||||units on a scale||95% Confidence Interval|Mean
2596619|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) follow-up period after vaccination|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.|||Subjects|||Number
2596620|NCT02207413|Primary|Number of Subjects Aged 3-17 Years Reporting the Occurrence of All Medically Attended Events (MAEs) .|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was a MAE that prevented normal activities. Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.|During the entire study period (approximately 28 days (primed subjects) and 56 days (unprimed subjects) following vaccination|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.|||Subjects|||Number
2596621|NCT02207413|Primary|Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms.|"Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling.~Any = occurrence of any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 = ORS symptoms that prevented normal activities. Related = ORS symptom assessed by the investigator as causally related to the vaccination."|During the 3-day (Days 0-2) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.|||Subjects|||Number
2596622|NCT02207413|Primary|Duration of Solicited General AEs in Subjects Aged 5-17 Years.|Duration was defined as number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented.|||Days||Full Range|Median
2596623|NCT02207413|Primary|Duration of Solicited General AEs in Subjects Aged 3-4 Years.|Duration was defined as number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 4 years, with at least one vaccine administration documented.|||Days||Full Range|Median
2596624|NCT02207413|Primary|Duration of Solicited Local AEs in Subjects Aged 3-17 Years.|Duration was defined as number of days with any grade of local symptoms.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.|||Days||Full Range|Median
2596625|NCT02207413|Primary|Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain, myalgia, shivering and fever (Fever = temperature above 38.0 degrees Celsius (°C)). Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature < 38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever = temperature above 39.0°C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented.|||Subjects|||Number
2596626|NCT02207413|Primary|Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>) 39.0°C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 4 years, with at least one vaccine administration documented.|||Subjects|||Number
2596627|NCT02207413|Primary|Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs).|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. >50mm.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.|||Subjects|||Number
2596649|NCT02207322|Secondary|Fatigue Scores (as Measured by FACT-Fatigue) at 3 Months|compare change in fatigue scores at 3 months adjusting for baseline scores Fatigue score ranges from 0 to 52 with higher scores indicating lower fatigue symptoms|3-months||||units on a scale||95% Confidence Interval|Mean
2596650|NCT02207322|Secondary|Fatigue Scores (as Measured by FACT-Fatigue) at Week-2|examine change in fatigue scores at week-2 adjusting for baseline scores Fatigue score ranges from 0 to 52 with higher scores indicating lower fatigue symptoms|week-2||||units on a scale||95% Confidence Interval|Mean
2596628|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting the Occurrence of Medically Attended Events (MAEs).|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was defined as MAE that prevented normal activities. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination.|During the entire study period (approximately 21 days following vaccination)|"The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.~1 subject withdrew consent in the Influsplit Tetra_LP Adult Group and did not complete the study but was administered a study vaccine dose."|||Subjects|||Number
2596629|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms.|Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any was defined as any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 ORS was defined as ORS symptoms that prevented normal activities. Related ORS was defined as ORS symptom(s) assessed by the investigator as causally related to the vaccination.|During the 3-day (Days 0-2) post-vaccination period|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.|||Subjects|||Number
2596630|NCT02207413|Primary|Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years.|Duration was defined as number of days with any grade of local and general symptoms.|During the 7-day (Days 0-6) post-vaccination period|"The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.~N = Number of subjects with the symptom and without the missing confirmed grade"|||Days||Full Range|Median
2596631|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue,gastrointestinal symptoms, headache, Joint Pain, myalgia, shivering and fever. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature ≥39.0°C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.|||Subjects|||Number
2596632|NCT02207413|Primary|Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs).|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 100 millimeters (mm) i.e. >100mm.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.|||Subjects|||Number
2596633|NCT02207400|Secondary|Bacterial Count at Baseline, After 6, 12, 24 and 32 Weeks|Microbiological samples were collected at baseline, 6 weeks, 12 weeks, 24 weeks and 32 weeks. Plaque was harvested from contra-lateral 1st molar teeth, where no restorations are present, using a sterile paper point. The paper point was immersed into 4 ml of Calgon Ringer's solution in a sterile bijou and kept on ice until they can be taken to the laboratory for processing (within 24 hours).|Baseline, 6, 12, 24 and 32 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.|||colony forming units per sample||Standard Deviation|Mean
2596634|NCT02207400|Secondary|Plaque Control (Overall and Interproximal Dental Plaque Scores) at 6, 12 and 24 Weeks.|The dental examiner had used the Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth. Interproximal Dental Plaque Scores were analyzed in the same way as for Overall scores but just based on mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces. Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5: 0= No plaque; 1= Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3= A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth; 4= Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth; 5= Plaque covering 2/3 or more of the crown of the tooth.|6, 12 and 24 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.|||Units on a scale||Standard Deviation|Mean
2596635|NCT02207400|Secondary|Bleeding Index (BI) at 6, 12 and 24 Weeks|BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|6, 12 and 24 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.|||Units on a Scale||Standard Deviation|Mean
2596651|NCT02207322|Secondary|Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 6 Months|compare PHQ-9 score at 6-months between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression|6-month||||units on a scale||95% Confidence Interval|Mean
2596652|NCT02207322|Secondary|Depression Scores Using Patient Health Questionnaire-9 (PHQ9) at 3 Months|compare PHQ-9 score at 3-months between study arms adjusting for baseline scores the PHQ-9 range from 0-27 with higher scores indicating higher depression|3-month||||units on a scale||95% Confidence Interval|Mean
2596774|NCT02204657|Secondary|Hypoglycemia||28 weeks until delivery||||episodes per patient||Inter-Quartile Range|Median
2596636|NCT02207400|Secondary|Modified Gingival Index (MGI)) at 6 and 12 Weeks.|MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration|6 and 12 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.|||Units on a scale||Standard Deviation|Mean
2596637|NCT02207400|Secondary|Number of Gingival Bleeding Sites at 6 and 12 Weeks|BI was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1mm into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|Baseline, 6 and 12 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.|||Number of bleeding sites||Standard Deviation|Mean
2596638|NCT02207400|Primary|Modified Gingival Index (MGI) at 24 Weeks|MGI was assessed on facial and lingual surfaces at two sites on each tooth (papillae and margin). The scoring of the MGI was performed under dental office conditions using a standard dental light for illuminating the oral cavity. Compressed air, water and mouth mirrors were available to each examiner. This procedure was performed by a single examiner. The MGI scoring system is as follows: 0 = absence of inflammation; 1 = mild inflammation; slight change in color, little change in color; little change in texture of any portion of the marginal or papillary gingival unit; 2 = mild inflammation; criteria as above but involving the entire marginal or papillar gingival units; 3= moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal or papillary gingival unit; 4 = severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration|24 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.|||Units on a scale||Standard Deviation|Mean
2596639|NCT02207400|Primary|Number of Gingival Bleeding Sites at 24 Weeks|The Bleeding Index was performed by a single examiner using a color coded periodontal probe. The probe was engaged approximately 1 millimetre (mm) into the gingival crevice. A moderate pressure was used whilst sweeping from interproximal to interproximal along the sulcular epithelium. The BI scoring system used is as follows: 0= No bleeding after 30 seconds; 1= Bleeding upon probing after 30 seconds; 2= Immediate bleeding observed|24 weeks|ITT population defined as those participants who had received study treatment and had at least one post-baseline efficacy measurement.|||Number of bleeding sites||Standard Deviation|Mean
2596640|NCT02207374|Secondary|Change in Glycosylated Haemoglobin A1c (HbA1c)|"The observed mean change in HbA1c values from baseline after 56 weeks of treatment. Changes in HbA1c were analysed using a mixed model for repeated measurements (MMRM) with treatment and pre-trial treatment at screening as fixed factors and baseline value as covariate. The data were analysed for the on-treatment without rescue medication observation period which includes observations noted at or after the date of first dose of randomised treatment and not after the last dose of the trial product (+ a 7-day visit window) or initiation of rescue medication."|Week 0, week 56|The full analysis set (FAS) included all randomised subjects who have received at least one dose of trial product. All subjects contributed to the statistical model of the data analysis, but not all subjects had a value at week 56.|||Percentage (%) of HbA1c||Standard Error|Least Squares Mean
2596641|NCT02207374|Secondary|Number of Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes|Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia: was an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The episodes mentioned here are treatment emergent hypoglycaemic episodes and defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-56 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).|Weeks 0-56|The safety analysis set (SAS) included all randomised subjects who had received at least one dose of semaglutide 0.5 mg (s.c.), semaglutide 1.0 mg (s.c.) or one additional OAD. Subjects in the SAS contributed to the evaluation “as treated”.|||Number of episodes|||Number
2596642|NCT02207374|Primary|Number of Treatment Emergent Adverse Events (TEAEs)|An adverse event (AEs) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. All AEs mentioned here are treatment emergent adverse events (TEAE) defined as an event that had onset date (or increase in severity) on or after the first day of exposure to randomised treatment (week 0-56 treatment period) and no later than the follow-up visit during the on-treatment observation period (date of last dose + 42 days).|Weeks 0-56|The safety analysis set (SAS) included all randomised subjects who had received at least one dose of semaglutide 0.5 mg (s.c.), semaglutide 1.0 mg (s.c.) or one additional OAD. Subjects in the SAS contributed to the evaluation “as treated”.|||Number of events|||Number
2596643|NCT02207322|Other Pre-specified|Caregiver Anxiety Symptoms Using Hospital Anxiety and Depression Scale (HADS)|compare caregiver anxiety at week-2 using hospital anxiety and depression scale (HADS)|week 2||||units on a scale||95% Confidence Interval|Mean
2596644|NCT02207322|Other Pre-specified|Caregiver Depression Symptoms Using Hospital Anxiety and Depression Scale (HADS)|compare caregiver depression at week-2 using hospital anxiety and depression scale (HADS) caregiver depression score ranges from 0-21 with higher score indicating higher depression symptoms|week 2||||units on a scale||95% Confidence Interval|Mean
2596775|NCT02204657|Primary|Glycemic Control by Measurement of HbA1c||From 28 weeks until delivery||||mean percentage||Standard Deviation|Mean
2596655|NCT02207322|Secondary|Anxiety Symptoms at 3 Months Using the Hospital Anxiety and Depression Scale (HADS)|compare anxiety symptoms using HADS at 3 months adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms|3 months||||units on a scale||95% Confidence Interval|Mean
2596656|NCT02207322|Secondary|Anxiety Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)|compare anxiety symptoms using HADS at week-2 adjusting for baseline scores HADS-anxiety scale range 0-21 with higher score indicating higher anxiety symptoms|week-2||||units on a scale||95% Confidence Interval|Mean
2596657|NCT02207322|Secondary|Depression Symptoms at 6 Month Using the Hospital Anxiety and Depression Scale (HADS)|Compare depression symptoms using HADS at 6 months adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms|6 months||||units on a scale||95% Confidence Interval|Mean
2596658|NCT02207322|Secondary|Depression Symptoms at 3 Month Using the Hospital Anxiety and Depression Scale (HADS)|compare depression symptoms using HADS at 3 months adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms|3 month||||units on a scale||95% Confidence Interval|Mean
2596659|NCT02207322|Secondary|Depression Symptoms at Week-2 Using the Hospital Anxiety and Depression Scale (HADS)|compare depression symptoms using HADS at week-2 adjusting for baseline scores HADS-depression scale range 0-21 with higher score indicating higher depression symptoms|week-2||||units on a scale||95% Confidence Interval|Mean
2596660|NCT02207322|Secondary|FACT-BMT Score at 6 Months|compare quality of life between the two study arms at 6 months adjusting for baseline scores Score range 0-164 with higher scores indicating better quality of life|6 Months||||units on a scale||95% Confidence Interval|Mean
2596661|NCT02207322|Secondary|FACT-BMT Score at 3 Months|adjusted patient-reported quality of life (QOL) at 3-month adjusting for baseline QOL scores Score range 0-164 with higher scores indicating better quality of life|3 months||||units on a scale||95% Confidence Interval|Mean
2596662|NCT02207322|Primary|Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) Score at Week-2|Compare quality of life (QOL) (FACT-BMT) scores at week-2 (day+5 for autologous, day +8 for myeloablative or reduced intensity allogeneic HSCT) adjusting for baseline QOL scores between the study arms. Score range 0-164 with higher scores indicating better quality of life|week-2||||units on a scale||95% Confidence Interval|Mean
2596663|NCT02207244|Secondary|Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24|The PSSD (24 hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.|Week 24|PSSD analysis set included all those participants who were randomized at Week 0 and had baseline PSSD score greater than 0. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab.|||Percentage of participants|||Number
2596664|NCT02207244|Secondary|Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group|The PSSD (24 hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.|Baseline and Week 16|PSSD analysis set included all those participants who had baseline PSSD scores as the average score of at least 4 days out of the 7 days prior to the Week 0 visit. Outcome measure was planned to be compared only for groups Placebo and Guselkumab 100 mg.|||units on a scale||Standard Deviation|Mean
2596665|NCT02207244|Secondary|Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group|The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease.|Week 16|Population analyzed included only randomized participants who had an ss-IGA score greater than or equal to (>=) 2 at baseline. Outcome measure was planned to be compared only for groups Placebo and Guselkumab 100 mg.|||percentage of participants|||Number
2596666|NCT02207244|Secondary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.|Week 16|Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
2597524|NCT02196714|Primary|T 1/2|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (T 1/2)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||h||Full Range|Mean
2596667|NCT02207244|Secondary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response, in the Guselkumab Group Compared to the Adalimumab Group at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.|Week 16|Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
2596668|NCT02207244|Secondary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 16|Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
2596669|NCT02207244|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group|The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.|Baseline, Week 16|Randomized analysis set included all participants who were randomized at Week 0 and with a baseline DLQI score. Outcome measure was planned to be compared only for groups Placebo and Guselkumab 100 mg.|||units on a scale||Standard Deviation|Mean
2596670|NCT02207244|Secondary|Cumulative Maintenance Rate of Psoriasis Area and Severity Index (PASI) 90 Response in the Placebo Group Compared to the Guselkumab Group Through Week 48 to Evaluate Loss of a PASI 90 Response|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. Cumulative maintenance rate was defined as percentage of participants who maintained their PASI 90 response through Week 48.|Through Week 48|Randomized analysis set included all participants who were randomized at Week 0 and who achieved a PASI 90 response at Week 28, were re-randomized to continue guselkumab or receive placebo and with at least one PASI assessment post Week 28.|||Percentage of Participants|||Number
2596671|NCT02207244|Secondary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.|Week 24|Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or who did not come for evaluation at Week 24 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
2596672|NCT02207244|Secondary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 24|Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or who did not come for evaluation at Week 24 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
2596673|NCT02207244|Secondary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 24|Randomized analysis set. Outcome measure was planned to be compared only for groups Guselkumab 100 mg and Adalimumab. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or who did not come for evaluation at Week 24 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
2596824|NCT02204150|Primary|Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule|Number of subjects from whom the quality OFDI imaging was obtained|Images will be acquired during the OFDI imaging session which should take an average of 5 minutes||||Participants|||Count of Participants
2596674|NCT02207244|Primary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these area was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.|Week 16|Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
2596675|NCT02207244|Primary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 16|Randomized analysis set included all participants who were randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
2596676|NCT02207231|Secondary|Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24|The PSSD (24-hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.|Week 24|PSSD analysis set included all those participants who were randomized at Week 0 and had baseline PSSD score greater than 0.|||percentage of participants|||Number
2596677|NCT02207231|Secondary|Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group|The PSSD (24-hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.|Baseline and Week 16|PSSD analysis set included all those participants who had baseline PSSD scores as the average score of at least 4 days out of the 7 days prior to the Week 0 visit.|||units on a scale||Standard Deviation|Mean
2596678|NCT02207231|Secondary|Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group|The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.|Week 16|Population analyzed included only randomized participants at Week 0 who had an ss-IGA score greater than or equal to (>=) 2 at baseline.|||percentage of participants|||Number
2596679|NCT02207231|Secondary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.|Week 16|Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
2596680|NCT02207231|Secondary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.|Week 16|Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
2596681|NCT02207231|Secondary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 16|Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
2596682|NCT02207231|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group|The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants. This secondary outcome measure was planned to include only the placebo and guselkumab arms.|Baseline, Week 16|Randomized analysis set included all participants who were randomized at Week 0 and have a baseline DLQI score.|||units on a scale||Standard Deviation|Mean
2596683|NCT02207231|Secondary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.|Week 24 and 48|Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.|||percentage of participants|||Number
2596684|NCT02207231|Secondary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 24 and 48|Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.|||percentage of participants|||Number
2596685|NCT02207231|Secondary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 24 and 48|Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.|||percentage of participants|||Number
2596686|NCT02207231|Primary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.|Week 16|Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
2596687|NCT02207231|Primary|Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16|The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 16|Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.|||percentage of participants|||Number
2596688|NCT02207088|Secondary|Percentage of Participants With Post-Treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment.|Within 12 weeks after the last dose of study drug|All randomized participants who received at least one dose of study drug (ITT population) with HCV RNA < LLOQ at the end of treatment and completed treatment.|||percentage of participants||95% Confidence Interval|Number
2607227|NCT02092311|Primary|Recurrent Varicocele|post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery|6 months||||participants|||Number
2596689|NCT02207088|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment.|Up to 24 weeks|All randomized participants who received at least one dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
2596690|NCT02207088|Primary|Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All randomized participants who received at least one dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
2596691|NCT02206828|Secondary|The Use of Symbotex™ Composite Mesh and Hospital Stay Duration|Hospital stay (Days) for patients treated for ventral hernia with Symbotex Composite mesh device|Baseline Day 0|For 8 patients there is 8 missing data respectively|||days||Standard Deviation|Mean
2596692|NCT02206828|Secondary|The Use of Symbotex™ Composite Mesh and Surgery Duration|Operative Time (min) for patients treated for ventral hernia|Baseline Day 0|3 approaches of surgery , thus operative time and hospital stay are provided according to the nature of the surgery the unit of Operative time is in minutes (specify in the title see below) And the unit of hospital stay is in days (speify in the title see below) Missing data on 4 patients.|||minutes||Standard Deviation|Mean
2596693|NCT02206828|Secondary|The Use of Symbotex™ Composite Mesh During Surgery Hernia Repair|Surgical technique approach for patients treated for ventral hernia with Symbotex™ Composite Mesh|Baseline Day 0||||Participants|||Count of Participants
2596694|NCT02206828|Secondary|Mesh Handling|ease of use / mesh Handling Mesh ease of use assessed by surgeons using Symbotex™ Composite Mesh for Patients treated for ventral hernia- Participant reflect surgeon who asses the feature of the mesh (for example, 68 surgeons agree that marking eases to place the mesh, 34 surgeons agree that the mesh is conformable to the anatomy etc..|Day 0 Baseline||||participants|||Number
2596695|NCT02206828|Secondary|Surgeon Satisfaction (Mesh Handling, Mesh Manipulability, Ease of Use)|Mesh ease of use assessed by surgeons using Symbotex™ Composite Mesh for Patients treated for ventral hernia|Day 0 Baseline|Number of Hernia, some patients exhibits more than 1 hernia (100 patients with 105 ventral hernias) Ease of use: results is based on 100 patients and 105 hernias (100 patients enrolled and having 105 hernias) , However results reported of subjects with missing data or not applicable data respectively;|||Hernia|Hernia||Count of Units
2596696|NCT02206828|Secondary|Patient Satisfaction|Patient satisfaction For long-term follow up, two sets of self-administered Quality of Life (QOL) and patient satisfaction questionnaires were administered by phone call at 1 year and 2 year follow-up.|Various (1 year and 2 year)||||Participants|||Count of Participants
2596697|NCT02206828|Secondary|Quality of Life for Patient|Quality of Life of patients treated for ventral hernia For long-term follow up, two sets of self-administered Quality of Life (QOL) and patient satisfaction questionnaires were administered by phone call at 1 year and 2 year follow-up.|Various ( 1 Month, 1 year and 2 Year follow up)||||Participants|||Count of Participants
2596698|NCT02206828|Secondary|Pain Assessment Measured With VAS Score|"Pain assessment measured with VAS* score~*VAS: The postoperative pain is assessed using a 0-10 Visual Analogue Scale. Worst pain experienced over the last 24 hours. Mild pain for VAS score between 0 and 3; Moderate pain for VAS score > 3 and > 6 ; Severe pain for VAS scores > 6"|Various ( Baseline Day 0, Day 1, Day 8, Month 1, Month 3, 1 year , 2 year||||units on a scale||Standard Deviation|Mean
2596699|NCT02206828|Primary|Incidence of Peri-operative and Post-operative Complications|"Primary endpoint focuses on complications (including recurrence) occurring during procedure, and in short, mid and long-term (measured at 1 month, 1 year and 2 year follow-up respectively) following ventral hernia repair.~All peri-, intra- and post- operative complications"|Various (measured at 1 month, 1 Year & 2 Year)|6 patients are lost to follow up at 1 year - 7 patients are lost to follow up at 2 year , it is described in the Participant Flow module Outcomes measure reflect Patients who completed each visits|||Participants|||Count of Participants
2596700|NCT02206776|Primary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.|Baseline and 1 Week||||Participants|||Count of Participants
2596701|NCT02206620|Secondary|Attention Network Test|"Attention Network Test (ANT) is 15 minute computerized test or reaction times with various cues and targets designed to assess alerting, orienting and executive control of attention. Deficits of attention are related to fall risk and may be affected by donepezil.~The delta of the Orienting Network Efficiency is reported for each phase (pre- and post-donepezil phase and pre- and post-placebo phase).~Details: In accordance with Fan et al. (2002), the subtraction method was applied to isolate the efficiency of the three attentional networks as follows: for the alerting network efficiency: mean RT NC trials − mean RT DC trials; for the orienting network efficiency: mean RT CC trials − mean RT SC trials; and for the executive network efficiency: mean RT I trials − mean RT C trials. For both the alerting and orienting effects, higher subtraction scores indicate greater efficiency; by contrast, the more efficient the executive network is, the lower the subtraction score."|Six weeks||||ms||Standard Deviation|Mean
2596702|NCT02206620|Secondary|Short-latency Afferent Inhibition is a Marker of Cortical Cholinergic Activity|Short-latency afferent inhibition (SAI) by a peripheral stimulation is a transcranial magnetic stimulation method to evaluate cortical cholinergic activity. Short-latency afferent Inhibition will be used to determine if our subjects with Parkinson's disease have evidence of reduced cholinergic tone which correlates with their measures of postural and gait instability. We report the SAI at the end of each phase (post-placebo phase and post-donepezil phase). SAI is reported in motor-evoked potential (MEP).|Six weeks|The average and standard deviation (SD) of the SAI at the end of each treatment is reported|||percentage of the unconditioned MEP||Standard Deviation|Mean
2596897|NCT02203630|Secondary|Number of Patients With ST-segment Abnormalities on ECG|ST Elevation of 1 mm in 2 or more consecutive leads or Horizontal or downsloping ST depression of 1 mm in 2 or more consecutive leads|Up to 28 days||||Participants|||Count of Participants
2596703|NCT02206620|Primary|Delta of the Variability of Stride Time While Walking|Variability in stride time time and an increase with dual tasking is another marker for increased fall risk in Parkinson's disease. Stride time variability was measured with inertial sensors attached to both feet. The delta for each phase is reported [post-donepezil - pre-donepezil for the donepezil phase, and post-placebo - pre-placebo for the placebo phase].|Six weeks|Variability of stride time was calculated from the stride time time-series as the coefficient of variation (CV, 100 multiplied by the SD of the stride times divided by the mean of each subject's stride times)|||percentage of gait cycle time||Standard Deviation|Mean
2596704|NCT02206620|Primary|Delta Medio-lateral Postural Sway Range (Foam)|Increased body sway while standing may be markers for increased risk of falling in Parkinson's disease. Sway was measured with an inertial sensor attached to the waist. Participants did this task on a foam pad. We reported the delta in the donepezil and placebo phases [post-donepezil - pre-donepezil for the donepezil phase, and post-placebo - pre-placebo for the placebo phase].|Six weeks||||m/s^2||Standard Deviation|Mean
2596705|NCT02206607|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last study drug administration in Period 4|The safety analysis population included all participants who received at least 1 dose of open-label, sponsor-provided metformin.|||participants|||Number
2596706|NCT02206607|Secondary|Terminal Elimination Half-Life (t1/2)|t1/2 is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period; number of participants analyzed (N) is number of evaluable participants for this outcome measure.|||hour||Standard Deviation|Mean
2596707|NCT02206607|Secondary|Area Under the Curve From Time Zero to Last Quantifiable PF-04937319 Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2596708|NCT02206607|Secondary|Time to Reach Maximum Observed PF-04937319 Plasma Concentration (Tmax)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.|||hours||Full Range|Median
2596709|NCT02206607|Secondary|Ratio of Maximum to Approximate Trough PF-04937319 Concentration (Cmax/C24)|Cmax/C24 is the ratio of maximum to approximate trough concentration, where Cmax is the overall maximum observed plasma concentration and C24 is the plasma concentration at 24 hours after the morning dose.|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2596710|NCT02206607|Secondary|PF-04937319 Plasma Concentration at 24 Hours After Morning Dose (C24)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
2596711|NCT02206607|Secondary|PF-04937319 Plasma Concentration at 16 Hours After Morning Dose (C16)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2596712|NCT02206607|Secondary|PF-04937319 Plasma Concentration at 5 Hours After Morning Dose (C5)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2596713|NCT02206607|Secondary|Maximum Observed PF-04937319 Plasma Concentration (Cmax)||0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The PK parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2596714|NCT02206607|Primary|Change From Reference in Weighted-Mean-Daily-Glucose (WMDG) on Day 1|MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed.|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, and 24 hours post-dose|The pharmacodynamic analysis included participants who had taken at least 1 dose of PF-04937319 and who had WMDG assessment for at least 1 modified-release formulation and the Reference (IR MST) formulation; n=number of participants evaluated in respective arms for category.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2596776|NCT02204579|Secondary|Change From Baseline in Fractional Excretion of Calcium (FECa) at 12 Hours Postdose||Baseline (Predose) to 12 Hours Postdose|Post-amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here n=number of participants analysed for specified category at the specified time points in each arm respectively.|||Fraction of excretion||Standard Deviation|Mean
2596715|NCT02206607|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]|AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time.|0 (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 11, 12.5, 14, 16, 20, 24, 36, 48, and 72 hours post-dose|The pharmacokinetic (PK) parameter analysis population included all randomized participants who received at least 1 dose of PF-04937319 and who had at least 1 of the PK parameters of interest measured and available in at least 1 period; number of participants analyzed (N) is number of evaluable participants for this outcome measure.|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2596716|NCT02206217|Secondary|Axial Length|Axial length (mm) was measured after cycloplegia using IOL Master|Baseline and 2 years|completed 2-year study|||mm||Standard Deviation|Mean
2596717|NCT02206217|Primary|Cycloplegic Refraction Change in SER|Change in cycloplegic SER (in diopter) that was measured using Shin-Nippon NVision-K 5001 autorefractor.|Baseline and 2 years|completed 2-year study|||Diopters (D)||Standard Deviation|Mean
2596718|NCT02206152|Primary|Difference in Epinephrine Secretion During the Morning Episodes of Hypoglycemia on Days One and Two Under the Two Treatment Conditions|Epinephrine secretion during hypoglycemia is assessed by collecting blood samples for measurement of epinephrine concentrations at baseline and every 15 minutes during the period of hypoglycemia (starting at point where blood glucose is first < 55 mg/dl) in the clamp studies done in the mornings of days 1 and 2 of both parts 1 and 2. .|8-10 weeks||||ug/ml||Standard Deviation|Mean
2596719|NCT02205983|Primary|"Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire"|"The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: Feel Drug, Feel High, Like Drug, and Want More. The Feel Drug, Feel High, Like Drug, and Want More subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome. The values shown below are only from week 4"|End of study (time 0 and approximately 4 weeks later), week 4 reported.||||units on a scale||Standard Deviation|Mean
2596720|NCT02205814|Secondary|Euro Quality of Life Questionnaire (EQ-5D-5L) Responder Rate|Response based on change ≥ 20 % from baseline for EQ-5D-5L index value|from baseline up to 6 weeks after randomisation|The secondary efficacy analysis was performed on the ITT-population (n=431).|||percentage of responders|||Number
2596721|NCT02205814|Secondary|Responder Rate According to OMERACT-OARSI Criteria|Percentage of responders according to Outcome Measures in Rheumatology-Osteoarthritis Research Society International criteria (OMERACT-OARSI criteria). Patients with at least 50 % improvement in pain or in function scores are considered responders. Alternatively, patients are considered responders if they show at least 20% improvement in at least two of the following scores: pain, function and Patients's Global Assessment (PGA) scores.|from baseline up to 6 weeks after randomisation|The secondary efficacy variables were analysed in the ITT population (n=431).|||percentage of responders|||Number
2596722|NCT02205814|Secondary|Change in WOMAC INDEX|The WOMAC VA 3.1 Index score (WOMAC INDEX) is the sum of WOMAC A (total pain), WOMAC B (stiffness) and WOMAC C (functional impairment) subscores. The WOMAC INDEX score ranges from 0 to 2400 mm, with higher scores indicating higher disease burden.|from baseline up to 6 weeks after randomisation|The secondary efficacy analysis was performed on the ITT population (n=431).|||units on a scale||Standard Deviation|Mean
2596723|NCT02205814|Primary|Change in WOMAC A|The validated Western Ontario and McMaster University questionnaire (WOMAC) was used to measure total knee pain choosing its visual analogue scale version (VAS). The WOMAC VA 3.1 A subscore (WOMAC A) ranges from 0 to 500 mm (summing up five VAS 0-100 mm) with higher scores indicating more pain.|from baseline up to 2 weeks after randomisation|The primary efficacy analysis was performed on the ITT-population (n=431).|||units on a scale||Standard Deviation|Mean
2596724|NCT02205801|Secondary|Total Pain Medication Utilization|Total operative opioid dosages administered converted to effective mg of Hydromorphine.|At follow up appointment 1-2 weeks postoperatively||||mg||Standard Deviation|Mean
2596725|NCT02205801|Secondary|Post Operative Nausea Score|"Nausea scores will either be verbally reported to nursing and recorded or reported on a questionnaire. The scores range 0-9 (zero means no symptom and 9 means very severe)."|At 2 weeks after operation||||units on a scale||Standard Deviation|Mean
2596726|NCT02205801|Secondary|Post Operative Pain|Pain scores will either be verbally reported to nursing and recorded or reported on a questionnaire. Back of neck pain scores range 0-10, throat pain scores range 0-9, incisional pain scores range 0-9 (zero means no pain and 9 or 10 means severe pain).|At four hour after operation||||units on a scale||Standard Deviation|Mean
2596727|NCT02205801|Primary|Intraoperative Fentanyl Administration|The total amount of Fentanyl administered during the procedure will be recorded.|During the procedure||||mcg||Standard Deviation|Mean
2596728|NCT02205476|Other Pre-specified|Volumetric & Colorimetric Scar Assessment (3D Imaging) at Part A Visit|Three-dimension digital photography was planned to be taken of the participants scars for determination of scar volume, height, and color performed in a subset of selected investigational centers equipped with specialized 3D photographic equipment.|52 weeks after initial scar revision surgery in study B5301001|The volumetric and colorimetric scar assessments were collected under this protocol but were not analyzed.||||||
2596729|NCT02205476|Primary|Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.|Part B: Baseline up to Week 15|Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.||||||
2596898|NCT02203630|Secondary|Total Time in Arrhythmia||Up to 28 days|only participants with arrhythmias included|||minutes|||Number
2596730|NCT02205476|Primary|Part B: Number of Participants With Clinical Laboratory Abnormalities|Clinical laboratory tests included clinical chemistry (sodium, potassium, chloride, bicarbonate, glucose, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma-glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase) and hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count) tests to be performed.|Part B: Baseline up to Week 15|Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.||||||
2596731|NCT02205476|Primary|Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities|Vital signs included pulse rate and systolic blood pressure and diastolic blood pressure.|Part B: Baseline up to Week 15|Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.||||||
2596732|NCT02205476|Secondary|Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit|Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe).|52 weeks after initial scar revision surgery in study B5301001|Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.|||units on scale||Standard Deviation|Mean
2596733|NCT02205476|Secondary|Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptom and Appearance Domain Score at Part A Visit|PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Subjects completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0 to 100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity.|52 weeks after initial scar revision surgery in study B5301001|Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.|||units on scale||Standard Deviation|Mean
2596734|NCT02205476|Secondary|Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit|Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin).|52 weeks after initial scar revision surgery in study B5301001|Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.|||units on scale||Standard Deviation|Mean
2596735|NCT02205476|Primary|Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit|Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable).|52 weeks after initial scar revision surgery in study B5301001|Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.|||units on scale||Standard Deviation|Mean
2596736|NCT02205333|Secondary|Number of Participants Positive for Human Anti-mouse Antibodies (HAMA)|The number of participants who developed detectable HAMA are presented. ImmuSTRIP® HAMA IgG ELISA Test System was used for detection, confirmation, and titration of HAMA in human serum with a HAMA positivity cut-off level of 74 nanogram per millilitre (ng/mL).|All treatment arms: Days 8, 15, 29, and end of treatment (up to 1 year). Additionally for MEDI6469 + rituximab arm: Days 3, 31, 59, and every 28 days thereafter until end of treatment (up to 1 year)|All the participants who received at least a one dose of MEDI6469.|||Participant|||Number
2596737|NCT02205333|Secondary|Terminal Phase Elimination Half-Life (T1/2)|The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469|MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.|All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.|||Day||Standard Deviation|Mean
2596738|NCT02205333|Secondary|Systemic Clearance (CL)|The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469|MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.|All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.|||liter per day||Standard Deviation|Mean
2596739|NCT02205333|Secondary|Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf)|The PK parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469|MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment.|All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.|||day*microgram per milliliter||Standard Deviation|Mean
2596777|NCT02204579|Secondary|Elimination Half-life (t1/2) of NPSP795 in Plasma||Baseline (Predose), and 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose|Post amendment PK analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion.|||hour||Standard Deviation|Mean
2596740|NCT02205333|Secondary|Maximum Observed Serum Concentration (Cmax)|The pharmacokinetics (PK) parameter was estimated using the non-compartmental analysis methods, based on the participant serum concentration-time data. The concentration-time curve was the result of blood sampling at specified time points and its measured concentration of MEDI6469|MEDI6469 monotherapy: Days 1, 2, 3, 8, 15, and 29; MEDI6469 + tremelimumab or durvalumab: Days 1, 2, 3, 4, 8, 15, 29, and end of treatment (up to 1 year); MEDI6469 + rituximab: Days 3, 4, 8, 15, 29, 31, 59, every 28 days thereafter, and end of treatment|All the participants who received at least a one dose of MEDI6469 and for whom PK blood samples were collected and evaluated.|||microgram per milliliter||Standard Deviation|Mean
2596741|NCT02205333|Secondary|Overall Survival (OS)|The OS was the duration from the start of study treatment until death due to any cause.|From Study entry until early termination (up to 1 year)|As-treated population|||Months||95% Confidence Interval|Median
2596742|NCT02205333|Secondary|Progression-free Survival (PFS)|Progression-free survival was the duration measured from the start of study treatment until the first documentation of PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.|From Study entry until early termination (up to 1 year)|As-treated population|||Months||95% Confidence Interval|Median
2596743|NCT02205333|Secondary|Duration of Response (DOR)|Duration of response was the duration from the first documented objective response to the first documented PD or death due to any cause, whichever occurred first. Progression was based on revised RECIST v1.1 criteria for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. PD according to revised RECIST v1.1 was defined as: at least a 20% increase in the sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. PD per Cheson criteria was defined as: any new lesion or increase by at least 50% of previously involved sites from nadir.|From Study entry until early termination (up to 1 year)|All the participants with an OR were included.|||Days|||Number
2596744|NCT02205333|Secondary|Disease Control Rate|Disease control rate: Percentage of participants with CR, PR, or SD (if they maintained SD for >= 8 weeks) according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR -disappearance of all target/non-target lesions; PR - at least a 30% decrease in sum of diameters of target lesions; SD - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD - at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Tumor assessments according to Cheson criteria were defined as follows: CR- disappearance of all evidence of disease; PR - regression of measurable disease and no new sites; SD- failure to attain CR/PR or PD; PD- any new lesion or increase by at least 50% of previously involved sites from nadir.|From study entry until early termination (up to 1 year)|As-treated population|||Percentage of participants|||Number
2596745|NCT02205333|Secondary|Objective Response Rate (ORR)|Objective response rate was defined as the percentage of participants with confirmed CR or confirmed PR according to revised RECIST v1.1 for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Confirmed CR and PR were those that persisted on repeat consecutive assessment >= 4 weeks after the initial documentation of response. Tumor assessments according to revised RECIST v1.1 were defined as follows: CR - disappearance of all target/non-target lesions; PR - at least a 30% decrease in the sum of the diameters of target lesions. Tumor assessments according to Cheson criteria were defined as follows: CR - disappearance of all evidence of disease; PR- regression of measurable disease and no new sites.|From study entry until early termination (up to 1 year)|As-treated population|||Percentage of participants|||Number
2596746|NCT02205333|Secondary|Best Overall Response (BOR)|Best overall response: Percentage (%) of participants with CR, partial response (PR), stable disease (SD), progressive disease (PD), or non-evaluable disease based on revised Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) for monotherapy and combination tremelimumab and durvalumab arms, and Cheson criteria for combination rituximuab arms. Per RECIST v1.1: CR-disappearance of all target/non-target lesions; PR at least a 30% decrease in sum of diameters of target lesions; SD-neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD-at least a 20% increase in sum of diameters of target lesions, or a substantial worsening in a non-target lesion, or the appearance of new lesions. Per Cheson criteria: CR-disappearance of all evidence of disease; PR-regression of measurable disease and no new sites; SD-failure to attain CR/PR or PD; PD-any new lesion or increase by at least 50% of previously involved sites from nadir.|From study entry until early termination (up to 1 year)|As-treated population|||Percentage of participants|||Number
2596747|NCT02205333|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as TEAEs|Electrocardiogram (ECG) parameters included atrial rate, PR interval, QRS duration, QTC interval, QT interval, and ventricular rate. All 12-lead ECGs performed during the study were obtained in triplicate. The TEAEs related to these ECG evaluation abnormalities were reported.|From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)|As-treated population|||Participant|||Number
2596748|NCT02205333|Primary|Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as TEAEs|Vital signs examination included assessment of temperature, blood pressure, pulse rate, and respiratory rate. Physical examination included assessments of head, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, urogenital, musculoskeletal, neurological, psychiatric, dermatological, hematologic/lymphatic, and endocrine systems. The TEAEs related to these vital sign and physical examination abnormalities were reported.|From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)|As-treated population|||Participant|||Number
2596778|NCT02204579|Secondary|Maximum Observed Drug Concentration (Cmax) of NPSP795 in Plasma||Baseline (Predose), and 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose|Post amendment PK analysis population included all randomized participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least one day of infusion.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2596749|NCT02205333|Primary|Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs|Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell [WBC] count with differential, red blood cell [RBC] count, hematocrit, hemoglobin, platelet count, mean corpuscular volume [MCV], and mean corpuscular hemoglobin concentration [MCHC]); serum chemistry (calcium, chloride, magnesium, creatinine, sodium, blood urea nitrogen [BUN], bicarbonate, glucose, aspartate transaminase [AST], total bilirubin, C-reactive protein, gamma-glutamyl transpeptidase [GGT], lactate dehydrogenase, uric acid, potassium, alanine transaminase [ALT], alkaline phosphatase, albumin, total protein, triglycerides, and cholesterol); urinalysis; and coagulation parameters.|From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)|As-treated population|||Participant|||Number
2596750|NCT02205333|Primary|Number of Participants With Treatment-emergent Serious Adverse Events|A serious adverse event (SAE) was any AE that resulted in death, immediately life threatening, required (or prolonged) inpatient (or existing) hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect in offspring of the participant, or an important medical event that could jeopardize the participant or required medical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs were defined as SAEs present at baseline that worsened in intensity after administration of study treatment or SAEs absent at baseline that emerged after administration of study treatment.|From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)|As-treated population|||Participant|||Number
2596751|NCT02205333|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAEs were events present at baseline that worsened in intensity after administration of study treatment or events absent at baseline that emerged after administration of study treatment.|From study treatment administration (Day 1) to 90 days after the last dose of study treatment or early termination of study (up to 1 year)|As-treated population: all the participants who received any study treatment.|||Participant|||Number
2596752|NCT02205333|Primary|Number of Participants With DLTs|The DLT was any Grade 3 or higher treatment-related toxicity (including liver transaminase elevation higher than 8×upper limit of normal [ULN] or total bilirubin higher than 5×ULN; any >=Grade 2 pneumonitis that did not resolve to <=Grade 1 within 3 days) that occurred during the DLT time frame, and excluded the following: Grade 3 fatigue for less than or equal to (<=) 7 days; Grade 3 endocrinopathy that was managed and the participant was asymptomatic; Grade 3 inflammatory reaction attributed to a local antitumor response that resolved to <=Grade 1 within 30 days; concurrent vitiligo or alopecia of any grade; Grade 3 infusion-related reaction that resolved within 6 hours; and any more than or equal to (>=) Grade 3 lymphopenia (unless clinically significant).|From the first dose of study treatment through 28 days after the first dose (up to 28 days)|DLT-evaluable population|||Participant|||Number
2596753|NCT02205333|Primary|Maximum Tolerated Dose (MTD) of MEDI6469|The MTD was the highest dose within a cohort where no more than 1 out of 6 participants experienced dose-limiting toxicities (DLTs) or the highest protocol-defined dose for each agent in the absence of exceeding the MTD.|From the first dose of study treatment through 28 days after the first dose (up to 28 days)|DLT-evaluable population: All participants enrolled in the dose-escalation phase who received study treatment per protocol during the first 28 days and completed safety follow-up through the DLT-evaluation period or experienced any DLT.|||milligram per kilogram (mg/kg)|||Number
2596754|NCT02205177|Secondary|Number of Participants Who Completed the Subject Safety and Treatment Adherence Interview|The number of patients that completed the summary of the qualitative interview will be used to enhance Anxiety Coach|Within 5 working days of Treatment Completion|No families from minimal contact responded to interview request. three of the families from the Face to Face condition did not respond to invitation to interview.|||Participants|||Count of Participants
2596755|NCT02205177|Primary|Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) at Treatment Completion|The Pediatric Anxiety Rating Scale (PARS) is an interview-based tool used to assess for the presence and severity of anxiety symptoms in children and adolescents utilizing parental and youth input to guide clinician ratings. The PARS has 5 questions. Four of those questions has a scale ranging from none (1) to extreme (5). The other question has a rating of 1-5. The total score ranges from 0 - 25, with 25 being the worst.|Within 5 working days of Treatment Completion||||score on a scale||Standard Deviation|Mean
2596756|NCT02204982|Secondary|Overall Response Rate (ORR)||Until disease progression, for up to 5 years from randomization||||Participants|||Count of Participants
2596757|NCT02204982|Primary|Progression-Free Survival (PFS)|Due to the small number of enrolled subjects and study being terminated, PFS endpoint analysis was not performed.|Until disease progression, for up to 5 years from randomization|Data could not be reported because the study was terminated early and a sufficient number of subjects and events were not available for analysis.||||||
2596758|NCT02204917|Secondary|Compare the Diagnostic Accuracy of Contrast Enhanced Voiding Urosonography (ceVUS) With Voiding CystoUrethroGraphy (VCUG) for Vesicoureteral Reflux Detection and Urethral Imaging in Children.|The diagnostic accuracy of ceVUS will be assessed by evaluation of the true positive, true negative, false positive and false negative cases of reflux and urethral imaging findings detected by ceVUS and VCUG examinations.|10-15 minutes.|Voiding Cysteourethrography (VCUG) is used as the reference standard the results for ceVUS.|||percentage||95% Confidence Interval|Number
2596779|NCT02204579|Secondary|Area Under the Concentration Time Curve Extrapolated to Infinity (AUC0-infinity) of NPSP795||Baseline (Predose), and 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose|Post amendment PK analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion.|||nanogram*hour per milliliter(ng·h/mL)||Standard Deviation|Mean
2596780|NCT02204579|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC[0-t]) of NPSP795||Baseline (Predose), and 15, 30 Minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 and 8 Hours Postdose|Post amendment pharmacokinetic (PK) analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion.|||nanogram*hour per millilitre (ng·h/mL)||Standard Deviation|Mean
2596759|NCT02204917|Primary|Number of Participants With Adverse Events Following Contrast Enhanced Voiding Urosonography (ceVUS) With OPTISON and Voiding Cystourethrography (VCUG).|"The overall safety and tolerability of ceVUS with OPTISON was assessed before, during and immediately after each ceVUS and VCUG examinations, and in follow-up telephone interviews. Assessments included:~evaluation of body systems for signs of generalized hypersensitivity, allergic or anaphylactoid reactions~monitoring of heart rate and pulse oxygen saturation~telephone questionnaire-based interview of parents/guardians and children 48 hours after the examinations for delayed adverse events.~The severity of any possible adverse event was classified as mild, moderate or serious and the onset of symptoms was categorized as acute, subacute or delayed according to the World Health Organization (WHO) classifications. In addition, the adverse event was classified as anticipated if it was expected given the study related procedures or unanticipated if the subject was exposed to greater risk than previously known or recognized."|Within 1 hour and up to 2 days after ceVUS and VCUG examinations completion.||||participants|||Number
2596760|NCT02204917|Primary|Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG).|"Presence or absence of vesicoureteral reflux identified by ceVUS and VCUG in each pelvic-ureter-unit (PUU) of each participant. PUU is an anatomic term that is used to describe the part of the urinary tract consisting of the renal calyces, pelvis and ureter.~Grading the severity of reflux detected by ceVUS and VCUG. Grade 0: absence of reflux. If reflux is present, a 5 grade scale (grades I-V) is used to evaluate its severity. Grade I: reflux in the ureter, grade II: reflux up to the renal pelvis, grade III: reflux up to the renal pelvis with mild dilation of the ureter and pelvicalyceal system, grade IV reflux up to the renal pelvis with moderate dilation but preserved papillary impressions, grade V: reflux up to the renal pelvis with severe dilation and loss of papillary impressions. Higher grades of reflux are associated with increased risk of urinary tract infection.~Imaging of the urethra during voiding (urethra visualized or not) and urethra pathology detection."|10-15 minutes.|In total, 59 kidneys with 62 pelvic-ureteric units (PUUs) in 30 children were analyzed.|||pelvic-ureteric units (PUUs)|Number of Pelvic-Ureteric-Units (PUUs)||Number
2596761|NCT02204761|Secondary|Number of Participants Alive|Number of participants alive.|Up to 3 months post-treatment||||Participants|||Count of Participants
2596762|NCT02204761|Secondary|Number of Participants With Local Control of Cancer|Number of participants who did not have local failure as defined by: tumor progression per Response Evaluation Criteria in Solid Tumors criteria - at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions inside the full dose radiation field.|Up to 3 months post-treatment||||Participants|||Count of Participants
2596763|NCT02204761|Secondary|Number of Participants With Grade 2 Toxicity Attributable to Radiation Treatment|Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. Grade 2 generally means medical therapy required to intervene due to toxicity.|Up to 3 months post-treatment||||Participants|||Count of Participants
2596764|NCT02204761|Primary|Number of Participants With Grade 3 or Greater Toxicity Attributable to Radiation Treatment|Toxicity will be graded based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3 generally means hospitalization required for management of side effects.|Up to 3 months post-treatment||||Participants|||Count of Participants
2596765|NCT02204748|Primary|Femoro-tibial Kinematics - Ramp Down|Degree of axial rotation and maximum weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.|3 months post-operative||||degrees||Standard Deviation|Mean
2596766|NCT02204748|Primary|Femoro-tibial Kinematics - Gait|Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during gait activity.|3 months post-operative||||degrees||Standard Deviation|Mean
2596767|NCT02204748|Primary|Femoro-tibial Kinematics - Deep Knee Bend|Degree of axial rotation and weight-bearing range-of-motion for implanted knee in vivo under fluoroscopic surveillance during deep knee bend activity.|3 months post-operative||||degrees||Standard Deviation|Mean
2596768|NCT02204748|Secondary|Max Ground Reaction Force - Ramp Down|"Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity was normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed maximum reaction force."|3 months post-operative||||percentage of body weight||Standard Deviation|Mean
2596769|NCT02204748|Secondary|Max Ground Reaction Force - Gait|"Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed maximum reaction force."|3 months post-operative||||percentage of body weight||Standard Deviation|Mean
2596770|NCT02204748|Secondary|Max Ground Reaction Force - Deep Knee Bend|"Collected simultaneously with fluoroscopy data, ground reaction forces were obtained using a force plate (fixed to the ground) while subject performed activity. Maximum force measured in the vertical direction measured during the described activity, then normalized with respect to participant's body weight. As such, the data are presented as the percentage of the individuals' body weight that was supported on the implanted knee using a force plate (fixed to the ground) and has been termed maximum reaction force."|3 months post-operative||||percentage of body weight||Standard Deviation|Mean
2596771|NCT02204748|Primary|Femoro-tibial Kinematics: Translation and Lift-off for Ramp Down|Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during ramp down activity.|3 months post-operative||||mm||Standard Deviation|Mean
2596772|NCT02204748|Primary|Femoro-tibial Kinematics: Translation and Lift-off for Gait|Amount of translation and lift-off for implanted knee in vivo under fluoroscopic surveillance during gait activity.|3 months post-operative||||mm||Standard Deviation|Mean
2596899|NCT02203630|Secondary|Number of Participants With Arrhythmia Events||Up to 28 days||||Participants|||Count of Participants
2596781|NCT02204579|Primary|Change From Baseline in Serum Parathyroid Hormone (PTH) at Specified Time Point||Baseline (Predose), 5.5 Hours, 8 Hours Postdose|Post amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.|||nanogram/liter (ng/L)||Standard Deviation|Mean
2596782|NCT02204579|Primary|Change From Baseline in Urinary Calcium at 12 Hours Postdose||Baseline (Predose) to 12 Hours Postdose|PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.|||millimole/liter (mmol/L)||Standard Deviation|Mean
2596783|NCT02204579|Primary|Change From Baseline in Serum Calcium at 12 Hours Postdose||Baseline (Predose) to 12 Hours Postdose|Post-amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.|||millimole/liter (mmol/L)||Standard Deviation|Mean
2596784|NCT02204579|Primary|Change From Baseline in Ionised Calcium at Specified Timepoint||Baseline (Predose), 4 Hours and 8 Hours Postdose|Post-amendment pharmacodynamic (PD) analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively.|||millimole/liter (mmol/L)||Standard Deviation|Mean
2596785|NCT02204579|Primary|Number of Participants With Clinically Significant Abnormalities Related to Physical Examination||From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)|Safety population included all participants who received at least 1 minute of study drug infusion (both pre-amendment and post-amendment participants).|||participants|||Number
2596786|NCT02204579|Primary|Number of Participants With Potentially Clinically Important Laboratory Abnormalities||From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)|Safety population included all participants who received at least 1 minute of study drug infusion (pre-amendment and post-amendment).|||participants|||Number
2596787|NCT02204579|Primary|Number of Participants With Clinically Significant Vital Signs and Electrocardiogram (ECG) Abnormalities||From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)|Safety population included all participants who received at least 1 minute of study drug infusion (both pre-amendment and post-amendment participants).|||participants|||Number
2596788|NCT02204579|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)||From Day 1 up to safety follow-up assessment (upto Day 17 after discharge)|Safety population included all participants who received at least 1 minute of study drug infusion (pre-amendment and post-amendment).|||participants|||Number
2596789|NCT02204566|Primary|Feasibility of a Tethered OFDI Capsule in Patients With Atrial Fibrillation Following RF Ablation That Swallow the OFDI Capsule|An investigator will assess the quality of the recorded images and movies obtained with each exam after the imaging is completed. A total of 6 subjects were enrolled in this study. 1 participant was not analyzed as they could not attempt to swallow the capsule.|After the completed imaging session||||Participants|||Count of Participants
2596790|NCT02204449|Other Pre-specified|Cardiac Rehabilitation Enrollment in Site Closer to Home|A blinded research assistant will call those patients who were re-referred to a cardiac rehabilitation site closer to their home to see if they enrolled in cardiac rehabilitation. The study coordinator will then compare this to enrollment rates (already determined by the blinded research assistant) of those who enrolled in the program at the hospital system in which they were inpatients.|8 weeks after patient is discharged from hospital||||participants|||Number
2596791|NCT02204449|Secondary|Cardiac Rehabilitation Referral|A blinded research assistant will examine patient medical records to determine if patients were referred to cardiac rehabilitation.|12 weeks after patient has been discharged from hospital||||participants|||Number
2596792|NCT02204449|Primary|Cardiac Rehabilitation Enrollment|A blinded research assistant will either examine medical records or call the participant (i.e., patient) at home to determine if they have enrolled in cardiac rehabilitation.|12 weeks after patient is discharged from hospital||||participants|||Number
2596793|NCT02204410|Primary|Clinical Global Impression (CGI) Improvement for Deficient Emotional Self-Regulation (DESR)|"The Clinical Global Impression (CGI) is a clinician rated measure of illness severity, improvement, and efficacy of treatment (collected at all study visits). We examined the CGI Improvement specifically. The CGI Improvement for Deficient Emotional Self-Regulation (DESR) was reported at baseline and completion. The CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is rated as:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Much worse~Very much worse"|Baseline and 12 Weeks|Ten participants completed at least 6 weeks of the 12 week trial. These 10 participants were included in the analysis.|||units on a scale||Standard Deviation|Mean
2596794|NCT02204410|Primary|Emotional Control Subscale of the Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent)|"The Behavior Rating Inventory of Executive Function - Parent Form (BRIEF-Parent) is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales. The Emotional Control subscale measures the impact of executive function problems on emotional expression and assesses a child's ability to modulate or control his or her emotional responses. It is a 10-item subscale, and each item is scored Never, Sometimes, or Often. Raw scores for all scales are computed with Software Portfolio (BRIEF-SP), which provides a raw score and T score (based on child's age) for each scale. Higher scores represent more greater emotional dysregulation."|Baseline and 12 Weeks|Ten participants completed at least 6 weeks of the 12 week trial. These 10 participants were included in the analysis.|||units on a scale||Standard Deviation|Mean
2596900|NCT02203630|Primary|Maximum Heart Rate||Up to 28 days||||beats/minute||Full Range|Mean
2596901|NCT02203578|Secondary|T Cell Kinetics - Reconstitution||Up to 12 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.||||||
2596795|NCT02204371|Secondary|PK/PD Modeling Analysis to Characterize the Relationship Between Pazopanib Trough Concentrations and Epistaxis Frequency and Duration/Severity|A repeated categorical event per time interval PK/PD modeling analysis was planned (data permitting) to characterize the relationship between pazopanib trough concentrations and epistaxis frequency and duration/severity. Due to the small sample size and the fact that only one dose was studied these analyses were not performed.|Weeks 3, 6, 9 and 12|Pharmacokinetic/Pharmacodynamic Population||||||
2596796|NCT02204371|Secondary|Graphical Exploration of PK/Pharmacodynamic (PD) Relationships Between Pazopanib Exposure and Selected PD|Graphical exploration of PK/PD relationships between pazopanib exposure and selected parameters was to be explored if data permitted. Due to the small sample size and the fact that only one dose was studied these analyses were not performed.|Weeks 3, 6, 9 and 12|Pharmacokinetic/Pharmacodynamic Population||||||
2596797|NCT02204371|Secondary|Plasma Concentration of GW786034 at the Indicated Time Points|Predose (trough) blood samples were collected at weeks 3, 6, 9, and 12. Blood samples for pharmacokinetic (PK) profile were collected at pre-dose, 1, 2, 3, 4, 6 and 8 hours post dose. Area under the curve (0-tau), Concentration tau (Ctau), and maximum concentration (Cmax) following repeat administration was to be studied if data permitted.|Weeks 3, 6, 9 and 12|Pharmacokinetic Population: The Pharmacokinetic Population includes participants who had a pharmacokinetic sample obtained and analyzed. Only those par. available at the indicated time points were analyzed (specified by n=X in the category titles).|||µg/mL||Standard Deviation|Mean
2596798|NCT02204371|Secondary|Number of Participants With Any Adverse Events (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.|From start of investigational product (IP) through the Study Phase (12 weeks post-dose) (assessed up to 28 weeks)|Safety Population|||Participants|||Number
2596799|NCT02204371|Secondary|Number of Participants With Urinalysis Data Meeting Criteria of Potential Clinical Concern|"Protein - values of clinical concern if change from trace at baseline to 3+ any time on-therapy or from 0 at baseline to 2+ any time on-therapy."|Up to Week 16|Safety Population|||Participants|||Number
2596800|NCT02204371|Secondary|Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern|The following ECG parameters were analyzed: PR, QRS, QT, corrected QT [QTc] intervals. Criteria for clinical concern:. QT where value is > 450, QT[QTc] where value is > 450, PR where value is < 110 or > 220, QRS where value is < 75 or >110.|Up to Week 16|Safety population|||Participants|||Number
2596801|NCT02204371|Secondary|Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern|The following laboratory parameters were analyzed in supine position after 10 minutes rest: Diastolic blood pressure (DBP), Systolic blood pressure (SBP) and Heart rate (HR). Values above upper limit of normal and below lower limit to normal have been presented as high and low respectively.|Up to Week 16|Safety Population|||Participants|||Number
2596802|NCT02204371|Secondary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Concern|The following laboratory parameters were analyzed: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, lymphocytes; alanine amino transferase (ALT), alkaline phosphatase (ALP), aspartate amino transferase (AST), gamma glutamyl transferase (GGT), total bilirubin, albumin, total protein, blood urea nitrogen, creatinine, uric acid, sodium, potassium, chloride, calcium, total carbondioxide, glucose, magnesium, and ferritin. Only those parameters for which at least one value of clinical concern are reported in the table. Values above upper limit of normal and below lower limit to normal have been presented as high and low respectively.|Up to Week 16|Safety Population: The Safety Population comprises of all participants who received at least one dose of study treatment. This population is based on the treatment the participant actually received.|||Participants|||Number
2596803|NCT02204371|Secondary|Overall Health-related (HR) Quality of Life (QOL) Score Measured Using SF-36v2 at Day 1, Week 6 and Week 12|SF-36v2 is a generic HR QOL instrument with 36 items covering 8 subscales (SS) clustering into 2 global scores, the physical component summary score (PCS: physical functioning (PF), role physical (RP), bodily pain (BP), and general health (GH)) and mental component summary score (MCS: vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH)). All scores are normalized so that mean score for a representative US population = 50, with a standard deviation = 10. Information was used to observe a direction in overall QOL. Ranges are shown below. Higher scores represent better QOL and minimum important differences are PF, 3; RP, 3; BP, 3; GH, 2; VT, 2; SF, 3; RE, 4; and MH, 3 PCS, 2; MCS, 3. Response Consistency Index (RCI) measures the consistency of responses to individual survey responses. Lower the score the more consistent the individual responses. SF-6D Health Utility Index (HUI) Score = 0 (worst measured health state) to 1 (best measured health state).|Day (D) 1, Week (W) 6 and Week 12|Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed (specified by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2596804|NCT02204371|Secondary|Change From Baseline in Ferritin at the Indicated Time Points|Only pre-infusion ferritin values have been included in the analyses. All ferritin measurements that fall within 5 days of iron infusion date are considered post-infusion. Baseline ferritin value is defined as the average of the last two measurements during the run-in period. Average of the last two measurements during the run-in period was calculated as sum of the last 2 measured values of ferritin divided by 2. Change from Baseline is calculated as the difference between the Post dose value at indicated visit minus Baseline value. Par. were evaluated at baseline, treatment period (Weeks 1.5, 3, 4.5, 6, 7.5, 9, 10.5 and 12) and follow-up period (16, 20, 24 and 28).|Baseline, Week 1.5, Week 3, Week 4.5, Week 6, Week 7.5, Week 9, Week 10.5, Week 12, Week 16, Week 20, Week 24 and Week 28|Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed (specified by n=X in the category titles).|||µg per L||Standard Deviation|Mean
2596825|NCT02204124|Secondary|Number of Participants Who Experienced Postoperative Complications|"-Complications experienced after surgery will be reviewed including:~secondary bleeding/hematoma~wound infection~gastroparesis~postoperative pancreatic fistula~intraabdominal abscess~anastomotic leakage~re-intervention (operational)~postop requirement for blood product transfusion~hospital mortality"|Up to 90 days postoperatively||||Participants|||Count of Participants
2596902|NCT02203578|Secondary|Rate of Documented Infection||Up to 12 months after initiation of romidepsin|Study was terminated early due to slow accrual and insufficient data was collected to assess this outcome measure.||||||
2596805|NCT02204371|Secondary|Change From Baseline in the Average of the Last 3 Ferritin Measures in the Dosing Period (Week 9, Week 10.5 and Week 12)|For post-Baseline ferritin assessments, average of the last 3 measurements of the dosing period (Weeks 9, 10.5 and 12) was computed. Only pre-infusion ferritin values have been included in the analyses. Baseline ferritin value is the average of the last two measurements during the run-in period. Average of the last two measurements during the run-in period was calculated as sum of the last 2 measured values of ferritin divided by 2. Change from Baseline was calculated as the average of the last 3 measured values of ferritin minus the Baseline value. Average of the last 3 measurements was calculated as sum of the last 3 measured values of ferritin divided by 3. If measurements were missing at one or two of the 3 visits at Weeks 9, 10.5 and 12, then the average was based on the available measurements.|Baseline, Week 9, Week 10.5 and Week 12|Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed.|||micrograms per liter (µg per L)||Standard Deviation|Mean
2596806|NCT02204371|Primary|Total Units of Packed Red Blood Cells (PRBCs) Transfused During the Entire Dosing and Follow-up Period by 4 Week Interval|Baseline PRBC transfused is defined as the number of units of PRBC transfused during the last 4 weeks of run-in period (i.e., Day -28 to Day -1). Total units of PRBCs transfused during the entire dosing and follow-up period was listed by 4 week interval. Individual participant data been reported.|Over the last 4 weeks of run-in and at 4 week intervals during dosing and follow-up|Pharmacodynamic Population|||Number of units|||Number
2596807|NCT02204371|Primary|Total Iron Intake Over the Entire Dosing and Follow-up Period by 4 Week Interval|Total iron intake at Baseline is defined as the sum total of iron intake (oral + intravenous infusion) during the last 4 weeks of run-in period (i.e., Day -28 to Day -1). Total iron intake over the entire dosing and follow-up period was listed by 4 week interval. Individual participant data has been reported.|Last 4 weeks of run-in and during last 4 weeks of dosing period|Pharmacodynamic Population|||Milligram|||Number
2596808|NCT02204371|Primary|Total Iron Intake Over the Last 4 Weeks of the Dosing Period|Total iron intake at Baseline is defined as the sum total of iron intake (oral + intravenous infusion) during the last 4 weeks of run-in period (i.e., Day -28 to Day -1). Total iron intake over the last 4 weeks of run-in and during last 4 weeks of dosing period was listed. Individual participant data has been reported.|Last 4 weeks of run-in and during last 4 weeks of dosing period|Pharmacodynamic Population|||Milligram|||Number
2596809|NCT02204371|Primary|Intensity of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)|Intensity of epistaxis based on daily diaries has been reported as total gushing and total non gushing from Baseline, On-Therapy (OT) to Follow-up (F). Individual participant data from the daily diaries has been reported.|Over last 2 weeks of the run-in phase and then 2 week intervals throughout treatment period and follow-up period (from daily diaries)|Pharmacodynamic Population|||Number of gushing/non-gushing nosebleeds|||Number
2596810|NCT02204371|Primary|Frequency of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)|Frequency of epistaxis based on daily diaries has been reported over Baseline, On-Therapy (OT) to Follow-up (F). Individual participant data from the daily diaries has been reported.|Over last 2 weeks of the run-in phase and then 2 week intervals throughout treatment period and follow-up period (from daily diaries)|Pharmacodynamic Population|||Number of nosebleeds|||Number
2596811|NCT02204371|Primary|Duration of Epistaxis Over the Last 2 Weeks of the Dosing Period and by Time Over the Entire Dosing and Follow-up Period by 2 Week Interval (From Daily Diaries)|Duration of epistaxis based on daily diaries has been reported over Baseline, On-Therapy (OT) to Follow-up (F). Individual participant data from the daily diaries has been reported.|Over last 2 weeks of the run-in phase and then 2 week intervals throughout treatment period and follow-up period (from daily diaries)|Pharmacodynamic Population|||Minutes|||Number
2596812|NCT02204371|Primary|Change From Baseline in Hemoglobin at the Indicated Time Points|Only pre-transfusion hemoglobin values have been included in the analyses. All hemoglobin values that fall within 5 days of packed red blood cells (PRBC) transfusion are considered as post-transfusion values. Baseline hemoglobin value is defined as the average of the last two measurements during the run-in period. Average of the last two measurements during the run-in period was calculated as sum of the last 2 measured values of hemoglobin divided by 2. Change from Baseline was calculated as the Post dose value at the indicated visit minus the Baseline value. Par. were evaluated at Treatment period (Weeks 1.5, 3, 4.5, 6, 7.5, 9, 10.5 and 12) and Follow-up period (Weeks 16, 20, 24 and 28).|Baseline, Week 1.5, Week 3, Week 4.5, Week 6, Week 7.5, Week 9, Week 10.5, Week 12, Week 16, Week 20, Week 24 and Week 28|Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed (specified by n=X in the category titles).|||g/L||Standard Deviation|Mean
2596813|NCT02204371|Primary|Change From Baseline in the Average of the Last 3 Hemoglobin Measures in the Dosing Period (Week 9, Week 10.5 and Week 12)|For post-Baseline hemoglobin assessments, average of the last 3 measurements of the dosing period (Weeks 9, 10.5 and 12) was computed. Only pre-transfusion hemoglobin values have been included in the analyses. Baseline hemoglobin value is the average of the last two measurements during the run-in period. . Average of the last two measurements during the run-in period was calculated as sum of the last 2 measured values of hemoglobin divided by 2. Change from Baseline was calculated as the average of the last 3 measured values of hemoglobin minus the Baseline value. Average of the last 3 measurements was calculated as sum of the last 3 measured values of hemoglobin divided by 3. If measurements were missing at one or two of the 3 visits at Weeks 9, 10.5 and 12, then the average was based on the available measurements.|Baseline, Week 9, Week 10.5 and Week 12|Pharmacodynamic Population. Only those par. available at the indicated time points were analyzed.|||Grams per liter (g/L)||Standard Deviation|Mean
2596823|NCT02204176|Primary|Total Physical Activity|"The Godin Leisure-Time Exercise Questionnaire (GLTEQ; Godin & Shephard, 1985) was used to assess the frequency of typical weekly strenuous, moderate, and mild exercise (open-ended format). Total exercise scores were also computed by multiplying each reported exercise frequency by its metabolic equivalent (MET) and then summing the totals: (strenuous x 9) + (moderate x 5) + (mild x 2) (Godin, Jobin, & Boullon, 1986). Higher scores on this scale indicates more exercise engagement.~Also, participants were loaned a pedometer to obtain objective measures of exercise activity. The pedometers allow participants to enter their weight and height and measure steps taken throughout the day based on this information. The devices automatically reset at midnight and store the information for 30 days."|2-3 months after initial intervention session||||total metabolic equivalent||Standard Error|Mean
2596814|NCT02204371|Primary|Change From Baseline in Epistaxis Severity Score at the Indicated Time Points|The Epistaxis (nose bleeding) severity score (ESS) is a 6-item par-reported outcome measure designed to be a uniform epistaxis severity scoring system to assess the effectiveness of specific treatments on HHT-related epistaxis. Four questions document epistaxis frequency, duration, intensity and need for treatment, whereas two additional questions detail the presence of anemia and if a par has required a blood transfusion as a consequence of their epistaxis. Questions are variably weighted and results are tabulated on a 0-10 scale (0=no disease, 10 = severe disease). The minimum important difference is 0.71. Baseline is the Day1 pre-dose assessment value. Change from Baseline is calculated as the Post dose value at the indicated visit minus the Baseline value. Par were evaluated at Baseline, Treatment period (Weeks 6 and 12) and Follow-up period (Weeks 16, 20, 24 and 28). Only those par available at the indicated timepoints were analysed (specified by n=X in the category titles).|Baseline, Week 6, Week 12, Week 16, Week 20, Week 24 and Week 28|Pharmacodynamic Population: All par. who received at least one dose of study treatment (Safety Population) and who also provided data from at least one pharmacodynamic assessment (hemoglobin, ferritin, epistaxis daily diary).|||Scores on a scale||Standard Deviation|Mean
2596815|NCT02204319|Other Pre-specified|Change in the Vulvar Pain Functional Scale Questionnaire|"Questionnaire of eleven questions involving specific functions that may impart pain in the vulvar region and patient response to present tolerance level. Questions have 4-5 answer choices weighted on a 0-3 scale of impairment, with 3 being worst.~Worst reported score of functional impact =33. No functional impact = 0"|Baseline, and after last treatment visit at Week 8|women average age of 26 +/- 5.533 Years with appropriate diagnoses|||percent change||Standard Deviation|Mean
2596816|NCT02204319|Secondary|Change in Patient Specific Functional Scale Questionnaire|Questionnaire that measures on a 0-10 scale (0= No function, and 10= normal function) one function that most impacts the patient's present symptoms (vaginal penetration/intercourse chosen as most important and pertinent) Measured amount of point change on the scale.|Baseline, and two weeks following last treatment at Week 8|women average 26+/- 5.533 Years of age who were not pregnant with appropriate diagnoses|||units on a scale||Standard Deviation|Mean
2596817|NCT02204319|Primary|Percent Improvement Change in Visual Analogue Pain Scale (VAS) Calculated With Q-tip Palpation Over 6 Sites From Baseline Visit to Follow up at Two Week From Last Visit|"III. Q-tip testing:~. Q-tip pressure will be applied at the following areas, in the exact order listed: 2:00, 10:00, 5:00, 7:00, 12:00, and 6:00. An average VAS report of pain taken overall and compared from first baseline visit to end of study re-assessment two weeks following last treatment.~• Pain intensity marked an a line with a point between 0-100 on the Visual Analogue Scale (VAS). A separate rating is recorded for each of the 6 numbered areas (see box 1 for reference). 100 is maximum pain level and 0 is no pain measured in centimeters per FDA guidelines for pain calculation on the VAS"|Average of all sites Compared from baseline visit and at 8 week (from start) follow up||||percent change from first to last Rx||Standard Deviation|Mean
2596818|NCT02204176|Other Pre-specified|Industriousness Level|"Industriousness was assessed using a 10-item Industriousness scale (Chernyshenko, 2003). Participants rated themselves on a 5-point Likert scale (1 = Disagree strongly, 5 = Agree strongly) indicating the extent to which, for example, they are someone who has high standards and works toward them; setting goals and achieving them is not very important to me [reversed], [or] invests little effort into my work [reversed] . Higher scores indicate greater industriousness level."|6 months after initial intervention session||||units on a scale||Standard Error|Mean
2596819|NCT02204176|Other Pre-specified|Industriousness Level|"Industriousness was assessed using a 10-item Industriousness scale (Chernyshenko, 2003). Participants rated themselves on a 5-point Likert scale (1 = Disagree strongly, 5 = Agree strongly) indicating the extent to which, for example, they are someone who has high standards and works toward them; setting goals and achieving them is not very important to me [reversed], [or] invests little effort into my work [reversed] . Higher scores indicate greater industriousness level."|2-3 months after initial intervention session||||units on a scale||Standard Error|Mean
2596820|NCT02204176|Secondary|Exercise Self-efficacy|"The 18-item multidimensional exercise self-efficacy scale (Benisovich, Rossi, Norman, & Nigg, 1998) assessed participants' confidence in being able to exercise despite bad weather, inconvenience, negative affect, exercising alone, excuse making, and resistance from others. Participants were asked to rate how confident [they] are to exercise when other things get in the way on a 5-point Likert scale (1 = Not at all confident, 5 = Extremely confident; αs = .89-.91 across assessments). Example items include, I don't have access to exercise equipment, I don't feel like it, and I am spending time with friends or family who do not exercise. All items on the scale were averaged for each participant. Higher scores indicate greater self-efficacy."|6 months after initial intervention session||||units on a scale||Standard Error|Mean
2596821|NCT02204176|Secondary|Exercise Self-efficacy|"The 18-item multidimensional exercise self-efficacy scale (Benisovich, Rossi, Norman, & Nigg, 1998) assessed participants' confidence in being able to exercise despite bad weather, inconvenience, negative affect, exercising alone, excuse making, and resistance from others. Participants were asked to rate how confident [they] are to exercise when other things get in the way on a 5-point Likert scale (1 = Not at all confident, 5 = Extremely confident). Example items include, I don't have access to exercise equipment, I don't feel like it, and I am spending time with friends or family who do not exercise. All items on the scale were averaged for each participant. Higher scores indicate greater self-efficacy for exercise."|2-3 months after initial intervention session||||units on a scale||Standard Error|Mean
2596822|NCT02204176|Primary|Total Physical Activity|"The Godin Leisure-Time Exercise Questionnaire (GLTEQ; Godin & Shephard, 1985) was used to assess the frequency of typical weekly strenuous, moderate, and mild exercise (open-ended format). Total exercise scores were also computed by multiplying each reported exercise frequency by its metabolic equivalent (MET) and then summing the totals: (strenuous x 9) + (moderate x 5) + (mild x 2) (Godin, Jobin, & Boullon, 1986). Higher scores indicate more exercise engagement.~Also, participants were loaned a pedometer to obtain objective measures of exercise activity. The pedometers allow participants to enter their weight and height and measure steps taken throughout the day based on this information. The devices automatically reset at midnight and store the information for 30 days."|6 months after initial intervention session||||total metabolic equivalent||Standard Error|Mean
2596875|NCT02203630|Secondary|Mean Troponin-I|From chart review (if available)|Up to 28 days|patients with troponin levels|||ng/mL||Full Range|Mean
2596876|NCT02203630|Secondary|Cause of Death||Up to 28 days||||Participants|||Count of Participants
2596826|NCT02204124|Secondary|Number of Participants Who Experienced Perioperative Complications|"-Complications experienced during surgery will be reviewed including:~Iatrogenic injury~need for conversion from laparoscopic approach to open procedure~need for the use of other hemostatic devices or therapies~intraoperative requirement of blood product transfusion"|Day of surgery||||Participants|||Count of Participants
2596827|NCT02204124|Secondary|Anesthesia Time|-Anesthesia time measured from the initiation of anesthesia induction to the time of extubation|Day of surgery||||minutes||Standard Deviation|Mean
2596828|NCT02204124|Secondary|Cost Using Thunderbeat Device|-Calculated by the indirect and direct costs during the hospital stay and the costs accumulated 90 days postoperatively|Up to 90 days postoperatively|The data for this outcome measure was not collected.||||||
2596829|NCT02204124|Secondary|Operative Time|-Operation time measured from the beginning of the surgical procedure (incision of the skin) to the end of the surgical procedure (closure of the skin).|Day of surgery||||minutes||Full Range|Median
2596830|NCT02204124|Primary|Post-op Morbidity|-This is a prospective study to evaluate post-operative morbidity following use of the ThunderbeatTM device during the Whipple procedure. This will be compared to patients whose Whipple procedure will be performed using conventional dissection and hemostasis techniques.|Up to 90 days postoperatively||||Participants|||Count of Participants
2596831|NCT02204124|Primary|Operative Blood Loss|"The measurement of estimated blood loss (EBL) will come from the intraoperative anesthesia notes where (EBL) is recorded during each surgical procedure~The estimate of operative blood loss is measured by volume in the suction canisters and pads and is historically documented by the operative nursing staff during the operation."|Day of surgery||||mL||Standard Deviation|Mean
2596832|NCT02204007|Secondary|Operative Time|Duration of the surgical case|time of surgery||||minutes||Full Range|Mean
2596833|NCT02204007|Primary|Acetabular Shell Version and Inclination|A CT scan of all patients will be obtained within 2 weeks of surgery to measure placement (acetabular version & inclination measured in degrees) of the acetabular shell|within 2 weeks of surgery||||degrees||Full Range|Mean
2596834|NCT02203916|Secondary|Percentage of Participants Who Achieved Both a Clinic DBP and SBP Response at Week 6|Percentage of participants who achieved both a clinic DBP and SBP response measured at week 6 defined as clinic DBP <90 mmHg and/or reduction of ≥10 mmHg from Baseline AND clinic SBP <140 mmHg and/or reduction of ≥20 mmHg from Baseline. DBP and SBP are based on the arithmetic mean of 3 serial blood pressure measurements.|Baseline and Week 6|Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).|||percentage of participants|||Number
2596835|NCT02203916|Secondary|Percentage of Participants Who Achieved a Clinic SBP Response at Week 6|SBP response is defined as clinic SBP <140 mmHg and/or reduction of ≥20 mmHg from Baseline. SBP is the arithmetic mean of 3 serial systolic blood pressure measurements.|Baseline and Week 6|Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).|||percentage of participants|||Number
2596836|NCT02203916|Secondary|Percentage of Participants Who Achieved a Clinic DBP Response at Week 6|Clinic DBP response is defined as clinic DBP <90 mmHg and/or reduction of ≥10 mmHg from Baseline. DBP is the arithmetic mean of 3 serial diastolic blood pressure measurements.|Baseline and Week 6|Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).|||percentage of participants|||Number
2596837|NCT02203916|Secondary|Change From Baseline to Week 6 in Trough Clinic Sitting Diastolic Blood Pressure (DBP)|The change in trough clinic sitting diastolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting diastolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic diastolic blood pressure as a covariate was used for analysis.|Baseline and Week 6|Participants from the FAS, including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).|||mmHg||Standard Deviation|Mean
2596838|NCT02203916|Primary|Change From Baseline to Week 6 in Trough Clinic Sitting Systolic Blood Pressure (SBP)|The change in trough clinic sitting systolic blood pressure measured at week 6 relative to baseline. The trough is the average of the non-missing values of 3 serial trough sitting systolic blood pressure measurements. Blood pressure was measured using a validated, automated device after the participant had been sitting for at least 5 minutes. Week 6 blood pressure was measured approximately 24 hours after the previous day's dose. An analysis of covariance (ANCOVA) model, with treatment group as a fixed effect and Baseline sitting clinic systolic blood pressure as a covariate was used for analysis.|Baseline and Week 6|Participants from the Full Analysis Set (FAS), including all randomized participants, who received at least 1 dose of double-blind study drug, with both a Baseline value and at least 1 post-baseline value, who were randomized only once. Missing values were imputed using last observation carried forward (LOCF).|||mmHg||Standard Error|Least Squares Mean
2596839|NCT02203851|Secondary|Percentage of Participants Achieving sPGA of Clear at Week 48 of Extended Dosing Period|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study.|Week 48|ITT Population summarized by the 4 treatment groups from the lead-in study|||percentage of participants||95% Confidence Interval|Number
2596877|NCT02203630|Secondary|Location of Death||Up to 28 days||||Participants|||Count of Participants
2596840|NCT02203851|Secondary|Percentage of Participants Achieving 100% Improvement in PASI (PASI100) Score at Week 48 in the Extended Dosing Period|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.|Baseline, Week 48|ITT population summarized by the 4 treatment groups from the lead-in study|||percentage of participants||95% Confidence Interval|Number
2596841|NCT02203851|Secondary|Percentage of Participants Achieving 75% Improvement in PASI (PASI75) Score at Week 48 in the Extended Dosing Period|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.|Baseline, Week 48|ITT population summarized by the 4 treatment groups from the lead-in study|||percentage of participants||95% Confidence Interval|Number
2596842|NCT02203851|Secondary|Percentage of Participants Achieving 50% Improvement in PASI (PASI50) Score at Week 48 in the Extended Dosing Period|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.|Baseline, Week 48|ITT population summarized by the 4 treatment groups from the lead-in study|||percentage of participants||95% Confidence Interval|Number
2596843|NCT02203851|Secondary|Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of Clear or Almost Clear at Week 48 of Extended Dosing Period|The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study.|Week 48|ITT Population summarized by the 4 treatment groups from the lead-in study|||percentage of participants||95% Confidence Interval|Number
2596844|NCT02203851|Primary|Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI90) Score at Week 48 in the Extended Dosing Period|Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.|Baseline, Week 48|ITT population: defined as all participants who received at least one dose of study drug in the study and summarized by the 4 treatment groups from the lead-in study (Study 1311.2; NCT02054481).|||percentage of participants||95% Confidence Interval|Number
2596845|NCT02203851|Primary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.|From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)|Safety population summarized by the group the participants who remained at 90 mg throughout the study and the participants who received 180 mg|||participants|||Number
2596878|NCT02203630|Secondary|28-day Mortality||Up to 28 days||||Participants|||Count of Participants
2596879|NCT02203630|Secondary|Length of Hospital Stay||Up to 28 days||||days||Full Range|Mean
2596880|NCT02203630|Secondary|Length of ICU Stay||Up to 28 days||||days||Full Range|Mean
2596881|NCT02203630|Secondary|Number of Participants Rehospitalized After Discharge||Up to 28 days||||Participants|||Count of Participants
2596882|NCT02203630|Secondary|Readmission to ICU||Up to 28 days|data was not collected||||||
2596883|NCT02203630|Secondary|Days Spent Out of the Hospital|Hospital free days|Up to 28 days||||days|||Number
2596884|NCT02203630|Secondary|Hospital Days Not in ICU|ICU free days|Up to 28 days||||days|||Number
2596846|NCT02203851|Primary|Number of Participants With Drug-related TEAEs|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.|From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)|Safety Population summarized by the group the participants who remained at 90 mg throughout the study and the participants who received 180 mg|||participants|||Number
2596847|NCT02203851|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the Adverse Event section for details.|From first dose of study drug in either the lead-in or extension study until 12 weeks after the last dose of study drug (approximately 4 years from the first dose in either the lead-in or extension study)|Safety population, which is the same as the Intent to Treat (ITT) population for this study (defined as all participants who received at least one dose of study drug in the study), summarized by the group the participants who remained at 90 mg throughout the study and the participants who received 180 mg|||participants|||Number
2596848|NCT02203838|Secondary|Change From Baseline in Clinical Global Impression - Severity Scores (CGI-S) to Days 29, 169 and End of Study|"The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Negative change from baseline scores indicate improvement in the severity of illness."|Baseline (Day 0), Baseline (Day 0), Day 29, Day 169 and End of Study (approximately Week 52)|Safety population. Population counts at each timepoint represent participants with an observation at that timepoint (all participants had baseline assessments).|||units on a scale||Standard Deviation|Mean
2596849|NCT02203838|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores to End of Study|"PANSS subscales:~Positive scale assesses 7 items: delusions, conceptual disorganization, hallucinations, excitement, grandiosity, suspiciousness/persecution, and hostility. Scale: 7 (absent) to 49 (extreme psychopathology)~Negative scale assesses 7 items: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Scale: 7 (absent) to 49 (extreme psychopathology)~General Psychopathology scale assesses 16 items: somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Scale: 16 (absent) to 112 (extreme psychopathology) Negative change from baseline scores indicate improvements."|Baseline (Day 0), End of Study (approximately Week 52)|Safety population. Population counts represent participants with an end of study observation (all participants had baseline assessments).|||units on a scale||Standard Deviation|Mean
2596850|NCT02203838|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score to Days 29, 169 and End of Study|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor judgement, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 PANSS items and ranges from 30 to 210, with 30 indicating absence of symptoms of schizophrenia and 210 indicating extreme ratings of all 30 symptoms. Negative change from baseline scores indicate improvements in symptoms.|Baseline (Day 0), Day 29, Day 169 and End of Study (approximately Week 52)|Safety population. Population counts at each timepoint represent participants with an observation at that timepoint (all participants had baseline assessments).|||units on a scale||Standard Deviation|Mean
2596851|NCT02203838|Primary|Participants With Markedly Abnormal Weight Gain Anytime During the Study as Compared to Baseline|Participants who were found to have gain >=7% and >=10% of their baseline weight at any point during the study (including unscheduled assessments) once treatment began.|Baseline (Day 0), Treatment (Day 1 up to Week 52)|Safety population of study participants with a baseline weight recorded and at least one post-treatment weight recorded.|||Participants|||Count of Participants
2596852|NCT02203838|Primary|Participants With Injection Site-Related Treatment-Emergent Adverse Events (TEAEs)|"An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date.~Adverse events were coded using MedDRA version 17.0. Preferred terms linked to injection site AEs are reported. Although a participant may have had 2 or more AEs, the subject is counted only once in each preferred term category. The same subject may appear in different preferred term categories."|Day 1 up to week 52|Safety population|||Participants|||Count of Participants
2596885|NCT02203630|Secondary|Days Without Dialysis|Dialysis-free days|Up to 28 days||||days|||Number
2596886|NCT02203630|Secondary|Number of Days Without Mechanical Ventilation|Mechanical ventilation-free days|Up to 28 days||||days|||Number
2596853|NCT02203838|Primary|Participants With Treatment-Emergent Adverse Events (TEAE)|"An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date. AEs are determined by the Investigator to be related or not related to the study drug.~A serious AE (SAE) is defined by federal regulation as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Although a subject may have had 2 or more adverse experiences the subject is counted only once in a category. The same subject may appear in different categories."|Day 1 up to week 52|Safety population -- participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2596854|NCT02203786|Secondary|Winnings on Slot Machine Upon Completion of Game|Credits|15-minutes||||credits||Standard Deviation|Mean
2596855|NCT02203786|Secondary|Speed of Play on Slot Machine Game|Number of individual spins in a 15-minute slot machine game. Each spin corresponds to one wager.|15-minutes||||individual spins/15-minutes||Standard Deviation|Mean
2596856|NCT02203786|Secondary|Betting Behaviour in Laboratory-based Slot Machine Game|Risk taking was operationally defined as credits wagered per spin (mean computed for total spins)|1x per test session (total of 4 test sessions) for duration of the study: 4 weeks (1 session/week)||||credits/spin on slot machine||Standard Deviation|Mean
2596857|NCT02203786|Secondary|Cognitive Task Performance|Response time to words (gambling, alcohol, positive affect, negative affect) as a percentage of neutral categorized words (parts of a building). This provides an index of the relative salience of stimuli from these four categories against a baseline of reaction to words with no clinical relevance or emotional valence. Smaller scores indicate faster relative response time to the test stimuli vs. neutral stimuli (i.e., greater salience)|At key points during testing: immediately after the slot machine, at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration)||||percentage of neutral categorized words||Standard Deviation|Mean
2596858|NCT02203786|Secondary|Diastolic Blood Pressure (DBP)|Measure changes from baseline, especially physiologic reactivity to the slot machine and amphetamine.|At key points in testing: immediately after the slot machine game (change from session baseline), and at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration)(change from session baseline).||||mm Hg||Standard Deviation|Mean
2596859|NCT02203786|Primary|Subjective Reinforcement Self-report Scales|Self-reported Confidence to Refrain from Gambling (0 - 10) was assessed at test session baseline, before the slot machine and after the slot machine (Phase 1); and before amphetamine and at peak amphetamine (Phase 2). The maximum score (10) denotes complete confidence to refrain from gambling (i.e., NO urge or compulsion to gamble); the minimum score (0) denotes complete lack of confidence to refrain from gambling (i.e., overwhelming urge to gamble). Scores between 10 and 0 denote intermediate confidence to refrain from gambling with LOWER scores denoting less confidence to refrain from gambling -- i.e., GREATER urge or compulsive motivation to gamble. Scores shown are based on single item visual analogue ratings 0-10 from each participant at the specified time point. The mean (SD) of these single item ratings is presented for each sub-group.|At key points in testing: immediately after the slot machine game, and at expected peak subjective-behavioral effects for amphetamine (90-minutes post-capsule administration).||||units on a scale||Standard Deviation|Mean
2596860|NCT02203747|Primary|Visual Distortion Symptoms|"Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: did not experience (rating = 0), mild (rating = 1), moderate (rating = 2), or severe (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3."|1 week|"Of the 45 subjects in the Pseudophakic implanted with toric IOL group, one (#307) was excluded due to a protocol deviation (subject visit was completed outside of the protocol-defined visit interval)."|||rating of visual distortion symptoms||Standard Deviation|Mean
2596861|NCT02203747|Primary|Visual Distortion Symptoms|"Subjective rating of visual distortion symptoms under overall conditions at baseline. Rating scale consisted of the following categories: did not experience (rating = 0), mild (rating = 1), moderate (rating = 2), or severe (rating = 3), therefore, the lower values represent the best outcome. The minimum score was 0 and the maximum score was 3."|Baseline|"Of the 45 subjects in the Pseudophakic implanted with toric IOL group, one (#102) was excluded due to a protocol deviation (improper method used to simulate visual distortion)."|||rating of visual distortion symptoms||Standard Deviation|Mean
2596862|NCT02203721|Primary|Uncorrected Intermediate Visual Acuity|Uncorrected Intermediate Visual Acuity at 6 months.|6 months|Intent to Treat population|||LogMAR||Standard Error|Mean
2596863|NCT02203721|Primary|Distance Corrected Intermediate Visual Acuity|FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.|At 6 months|Intent to Treat Population|||LogMAR||Standard Error|Mean
2596864|NCT02203630|Other Pre-specified|Inotropes Used||Up to 28 days|||||||
2596865|NCT02203630|Other Pre-specified|Diuretic Agents Used||Up to 28 days|||||||
2596866|NCT02203630|Other Pre-specified|Anti-hypertensive Agents Used||Up to 28 days|||||||
2596867|NCT02203630|Other Pre-specified|Mean Central Venous Oxygen Saturation|From chart review (if available)|Up to 28 days|patients with central venous pressure readings|||mm/Hg||Full Range|Mean
2596868|NCT02203630|Other Pre-specified|Mean Metabolic Panel Laboratory Values|From chart review (if available)|Up to 28 days|||||||
2596869|NCT02203630|Other Pre-specified|Mean Central Venous Pressure||Up to 28 days||||mm/Hg||Full Range|Mean
2596870|NCT02203630|Other Pre-specified|Mean Blood Pressure (Maximum and Minimum)||Up to 28 days||||mm/Hg||Full Range|Mean
2596871|NCT02203630|Secondary|Amount of Time Non-study Vasopressors Used||Up to 28 days|participants receiving non-study vasopressors|||hours|||Number
2596872|NCT02203630|Secondary|Number of Participants Receiving Non-study Vasopressors||Up to 28 days||||Participants|||Count of Participants
2596873|NCT02203630|Secondary|Creatinine Kinase (CK)|From chart review (if available)|Up to 28 days|patients with CK levels|||units/L||Full Range|Mean
2596874|NCT02203630|Secondary|CK-MB|From chart review (if available)|Up to 28 days|patients with CK-MB levels|||ng/mL||Full Range|Mean
2596910|NCT02203565|Primary|Percent of Women Who Develop Grade 3 or 4 Radiation Dermatitis (as Defined by the Stanford Radiation Dermatitis Scoring System) During a Course of Radiation Therapy|"Stanford Radiation Dermatitis Scoring System:~Grade Clinical finding~0 No skin change~1 Faint, barely detectable erythema 2 Follicular rash, hyperpigmentation, evolving erythema 3 Dry desquamation, brisk erythema 4 Moist desquamation 5 Bleeding, ulceration, and/or infection"|Baseline to up to 6 weeks after completion of therapy|Patients with complete data for analysis. While 20 patients were enrolled in the study, only 14 had data available for analysis.|||Participants|||Count of Participants
2596911|NCT02203357|Other Pre-specified|Safety of HBV Vaccine Determined by Number of Participants With Adverse Events|Participants were monitored for any adverse events occurring within 30 min after each injection for immediate reactions and instructed to measure axillary temperature and record selected injection-site reactions (pain, erythema, induration, swelling, pruritus, cutaneous rash) and systemic reactions (headache, vomiting, asthenia, allergic reaction, fatigue, diarrhea, myalgia, general malaise, etc.) on the day of vaccination and the subsequent 3 days. Adverse reactions were graded or categorized according to the standard guideline for adverse reactions grading in vaccine clinical trials as Grade 1−3.|0-3 day after the first dose of immunization||||number of participants|||Number
2596912|NCT02203357|Secondary|Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults|"The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.~The GMCs of anti-HBs antibody will be compared among the three vaccine groups. The dynamic changes of seroprotection rates and GMCs of anti-HBs antibody will also be analyzed over the 2 years."|2-year after the first dose of the regimens||||mIU/ml||95% Confidence Interval|Geometric Mean
2596913|NCT02203357|Secondary|Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults|"The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.~The GMCs of anti-HBs will be compared among the three vaccine groups."|1-year after the first dose of the regimens||||mIU/ml||95% Confidence Interval|Geometric Mean
2596914|NCT02203357|Primary|Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults|"The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml.~The GMCs of anti-HBs antibody will be compared among the three vaccine groups."|one month after a series vaccination of the regimen||||mIU/ml||95% Confidence Interval|Geometric Mean
2596915|NCT02203331|Secondary|Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=4 as Measured on NRS by Question 1 of ESD|Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was >=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.|Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)|It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.|||percentage of days||Standard Deviation|Mean
2596916|NCT02203331|Secondary|Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain >=4 as Measured on NRS by Question 1 of ESD|Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=4 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that window where Item 1 of the ESD was >=4. Here, number of subjects 'n' signifies evaluable subjects for the respective category.|Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)|It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.|||percentage of days||Standard Deviation|Mean
2596917|NCT02203331|Secondary|Change From Baseline (Last 28 Days Before Randomization) to Cycle 1, 2, and 3 in Percentage of Days With Pain >=7 as Measured on NRS by Question 1 of ESD|Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was >=7. Here, number of subjects 'n' signifies evaluable subjects for the respective category.|Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)|It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.|||percentage of days||Standard Deviation|Mean
2596938|NCT02203032|Secondary|Percentage of Participants With an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) at Week 28|The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 28|Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.|||percentage of participants|||Number
2608987|NCT02071290|Primary|ROTEM EXTEM A10|Change in ROTEM parameter A10 over 24 hours from Admission|0 (Admission), 1, 3, 24 hours||||mm||Inter-Quartile Range|Median
2596918|NCT02203331|Secondary|Percentage of Days During Baseline (Last 28 Days Before Randomization) and Cycles 1, 2, and 3 With Pain Greater Than or Equal to (>=) 7 as Measured on NRS by Question 1 of ESD as Measured on NRS by Question 1 of ESD|Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The percentage of days with pain >=7 within a 28-day window was calculated as 100 divided by the number of non-missing days within that 28-day window multiplied by the number of days within that 28-day window where item 1 of the ESD was >=7.|Baseline (last 28 days before randomization), Cycle 1 (Treatment 1), Cycle 2 (Treatment 2), and Cycle 3 (Treatment 3)|It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.|||percentage of days||Standard Deviation|Mean
2596919|NCT02203331|Secondary|Absolute Change in Mean Pain From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment(Day1-28), Second Cycle Under Study Treatment(Day29-56),Third Cycle Under Study Treatment (Day57-84) as Measured on NRS by Question1 of ESD|Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain within a 28-day window was calculated as the sum of ESD item 1 within that 28-day window divided by the number with non-missing days within that 28-day window. Here, number of subjects 'n' signifies evaluable subjects for the respective category.|Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56), and third cycle (Treatment 3) (last 28 days of the treatment period, Day 57-84)|It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.|||units on a scale||Standard Deviation|Mean
2596920|NCT02203331|Secondary|Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to First Cycle Under Study Treatment (Day 1-28) and to Second Cycle Under Study Treatment (Day 29-56) as Measured on NRS by Question 1 of ESD|Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, subjects were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.|Baseline (last 28 days before randomization), first cycle (Treatment 1) (Day 1-28), second cycle (Treatment 2) (Day 29-56)|It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.|||units on a scale||Standard Deviation|Mean
2596921|NCT02203331|Primary|Absolute Change in Mean Pain of the 7 Days With Worst EAPP From Baseline (Last 28 Days Before Randomization) to End of Treatment (Last 28 Days of Treatment Period, Days 57-84) as Measured on NRS by Question 1 of ESD|Pain intensity was assessed on 11-point (0-10) NRS by question 1. In question 1, participants were asked to rate the pain in the target area during the past 24 hours, where 0= no pain and 10= worst imaginable pain and responses were recorded in ESD. The mean pain of the 7 days with worst EAPP within a 28-day window was calculated as the sum of ESD item 1 on 7 days with worst EAPP within that 28-day window divided by 7.|Baseline (last 28 days before randomization), end of treatment (Treatment 3) (last 28 days of the treatment period, Day 57-84)|The dose-response analysis was performed using the MCP-Mod method with groups containing LNG, ATZ + LNG, and Placebo. It was analyzed using the per-protocol set (PPS) with evaluable participants for this endpoint.|||units on a scale||Standard Deviation|Mean
2596922|NCT02203162|Primary|Change in Cough Reflex Sensitivity (Log C5)|Measurement of cough reflex sensitivity to capsaicin (C5) performed 15 minutes and 24 hours after electronic cigarette use session. Changes in cough reflex sensitivity 15 minutes after e-cig use compared to baseline will be assessed. In addition, cough reflex sensitivity 24 hours after e-cig exposure will also be measured, so that duration of any changes noted after 15 minutes can be assessed. Increase in C5 means decrease in cough reflex sensitivity. Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.|Baseline, 15 minutes, and 24 hours post-exposure to e-cig.||||log C5||95% Confidence Interval|Mean
2596923|NCT02203149|Secondary|Part 2: Percentage of Participants Achieving HCV RNA <LLoQ Over Time After Active Treatment|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA <LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.|Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24|All randomized participants in Part 2 who have received ≥1 dose of active study treatment and who have any follow-up efficacy measurement. Data for participants in Part 1 were analyzed and reported separately.|||percentage of participants||95% Confidence Interval|Number
2596924|NCT02203149|Secondary|Part 2: Percentage of Participants Achieving Undetectable HCV RNA Over Time After Active Treatment|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.|Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24|All randomized participants in Part 2 who have received ≥1 dose of active study treatment and who have any follow-up efficacy measurement. Data for participants in Part 1 were analyzed and reported separately.|||percentage of participants||95% Confidence Interval|Number
2597018|NCT02202759|Secondary|Overall Survival (OS)|Overall survival is defined as the time in days from the date of first study drug administration to the date of death.|Until death or 6 months after the last patient completes treatment—whichever occurs first (Up to 17 months)|Response-evaluable population, all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 postbaseline response assessment.|||days||Full Range|Median
2596925|NCT02203149|Primary|Part 2: Percentage of Participants That Discontinued Initial Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.|Up to Study Week 12 in Part 2|All randomized participants in Part 2 who received ≥1 dose of study treatment and had any safety follow-up data. Participants in the Deferred Arm would have received only placebo treatment up to Study Week 12. Data for participants in Part 1 were analyzed and reported separately.|||percentage of participants|||Number
2596926|NCT02203149|Primary|Part 2: Percentage of Participants Experiencing an AE During Initial Treatment and First 4 Follow-Up Weeks|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period and first 4 follow-up weeks, and the primary safety statistical analysis compared the percentage of participants with events between the Part 2 Immediate Treatment Arm and the Part 2 Deferred Treatment Arm while receiving placebo.|Up to 4 weeks following initial treatment in Part 2 (Up to total of 16 weeks)|All randomized participants in Part 2 who received ≥1 dose of study treatment and had any safety follow-up data. Participants in the Deferred Arm would have received only placebo treatment up to Study Week 16. Data for participants in Part 1 were analyzed and reported separately.|||percentage of participants|||Number
2596927|NCT02203149|Secondary|Part 1: Percentage of Participants Achieving HCV RNA Below the Lower Limit of Quantitation (<LLoQ) Over Time|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA <LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.|Part 1 TW2, TW4, TW12, EOT, FUWK4, FUWK12, FUWK24|All randomized participants in Part 1 who have received ≥1 dose of study treatment and who have any follow-up efficacy measurement. Data for participants in Part 2 were analyzed and reported separately.|||percentage of participants||95% Confidence Interval|Number
2596928|NCT02203149|Secondary|Part 1: Percentage of Participants Achieving Undetectable HCV RNA Over Time|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.|Part 1 Treatment Weeks (TW)2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24|All randomized participants in Part 1 who have received ≥1 dose of study treatment and who have any follow-up efficacy measurement. Data for participants in Part 2 were analyzed and reported separately.|||percentage of participants||95% Confidence Interval|Number
2596929|NCT02203149|Primary|Part 1: Percentage of Participants That Discontinued Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period through FUWK4.|Up to Study Week 12 in Part 1|All randomized participants in Part 1 who received ≥1 dose of study treatment and had any safety follow-up data. Data for participants in Part 2 were analyzed and reported separately.|||percentage of participants|||Number
2596930|NCT02203149|Primary|Part 1: Percentage of Participants Experiencing an Adverse Event (AE) During Treatment and First 4 Follow-Up Weeks|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary safety evaluation was limited to the initial treatment period through Follow-up Week 4 (FUWK4).|Up to 4 weeks post last dose in Part 1 (Up to total of 16 weeks)|All randomized participants in Part 1 who received ≥1 dose of study treatment and had any safety follow-up data. Data for participants in Part 2 were analyzed and reported separately.|||percentage of participants|||Number
2596939|NCT02203032|Secondary|Number of Visits at Which Participants Achieved an IGA Score of Cleared (0) From Week 28 Through Week 40|The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 28 through Week 40|Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.|||visits||Standard Deviation|Mean
2608988|NCT02071290|Primary|ROTEM EXTEM CFT|Change in ROTEM parameter Clot Formation Time (CFT) over 24 hours from Admission|0 (Admission), 1, 3, 24 hours||||Seconds||Inter-Quartile Range|Median
2596931|NCT02203149|Primary|Part 2: Percentage of Treatment-naïve Participants in the Immediate Treatment Arm Achieving Sustained Viral Response at 12 Weeks After The End of All Treatment (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® Taqman quantitative reverse transcription-polymerase chain reaction (RT-PCR) assay, v2.0, which had a lower limit of quantification (LLoQ) of 1.2 Log IU/mL (15 IU/mL) and a lower limit of detection (LLoD) below 15 IU/ml (no specific value). SVR12 was defined as undetectable HCV RNA (target not detected) at 12 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals (CIs) for the SVR12 rate. The lower limit of the 95% CI was compared to the reference rate of 75%; a lower CI limit that was higher than the reference rate would confirm the primary hypothesis and indicate that that the treatment combination was efficacious. As pre-specified in the protocol, only the Immediate Treatment Arm of Part 2 (treatment naïve participants) was included in the primary efficacy analysis.|12 weeks after end of all therapy in Part 2 (Study Week 24 of Part 2)|The primary efficacy analysis was assessed in all treatment-naïve participants randomized to the Part 2 Immediate Treatment Arm who received ≥1 dose of study treatment and had any follow-up efficacy measurement. No other arms were analyzed for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2596932|NCT02203071|Other Pre-specified|Number of Participants Who Were Able To Return To Return to Work or Sports Activity|"This is a two question survey administered to subjects that obtains subjective data Yes / No regarding whether the subject has been able to return to work or sports activity since surgery."|Approximately 2 years|There were 6 screen fails and 10 enrolled subjects who did not complete the study. Fifteen patients who were screened, consented, and enrolled, completed the 2-year study. Five patients who completed the study were assigned to the MSP treatment group and ten were assigned to the BioCartilage treatment group.|||Participants|||Count of Participants
2596933|NCT02203071|Other Pre-specified|International Knee Documentation Committee (IKDC) Subjective Portion|"The IKDC Questionnaire is a subjective scale that provides patients with an overall function score. The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Meanwhile, the sports activity subscale focuses on functions like going up and down the stairs, rising from a chair, squatting and jumping. The knee function subscale asks patients one simple question: how is their knee at present versus how was their knee prior to injury?~Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function."|Approximately 2 years|There were 6 screen fails and 10 enrolled subjects who did not complete the study. Fifteen patients who were screened, consented, and enrolled, completed the 2-year study. Five patients who completed the study were assigned to the MSP treatment group and ten were assigned to the BioCartilage treatment group.|||score on a scale||Standard Deviation|Mean
2596934|NCT02203071|Other Pre-specified|Knee Injury and Osteoarthritis Outcomes Score (KOOS)|The Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment.|Approximately 2 years|There were 6 screen fails and 10 enrolled subjects who did not complete the study. Fifteen patients who were screened, consented, and enrolled, completed the 2-year study. Five patients who completed the study were assigned to the MSP treatment group and ten were assigned to the BioCartilage treatment group.|||score on a scale||Standard Deviation|Mean
2596935|NCT02203071|Other Pre-specified|Marx Activity Rating Scale|The Marx Scale consists of four questions concerning four activities or actions: running, cutting, deceleration, and pivoting. The patient or survey respondent is asked to report on the frequency with which they performed the activity in their healthiest state within the past year. The four knee functions are rated on a 5-point scale of frequency and scores are added up to a minimum score of 0 and a maximum of 16 points, with a higher score indicating more frequent participation.|Approximately 2 years|There were 6 screen fails and 10 enrolled subjects who did not complete the study. Fifteen patients who were screened, consented, and enrolled, completed the 2-year study. Five patients who completed the study were assigned to the MSP treatment group and ten were assigned to the BioCartilage treatment group.|||score on a scale||Standard Deviation|Mean
2596936|NCT02203071|Secondary|Short Form-12 Health Survey (SF-12)|The 12-item Short Form Survey (SF-12) is a general health questionnaire. The SF-12 was constructed using questions drawn from each of the 8 dimensions of the MOS 36 item Short Form Survey (SF-36). It is designed to have similar performance to the SF-36, while taking less time to complete. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Approximately 2 years|There were 6 screen fails and 10 enrolled subjects who did not complete the study. Fifteen patients who were screened, consented, and enrolled, completed the 2-year study. Five patients who completed the study were assigned to the MSP treatment group and ten were assigned to the BioCartilage treatment group.|||score on a scale||Standard Deviation|Mean
2596937|NCT02203071|Primary|MRI Repair Tissue Comparison|The primary endpoint is to determine whether subjects receiving a marrow stimulating procedure (MSP) augmented with BioCartilage have improved outcomes (MRI) compared to subjects who receive MSP without the use of BioCartilage. Quantitative (%fill) and qualitative (tissue quality) MRI assessments of repair tissue will be performed by a musculoskeletal (MSK) radiologist who is blinded to treatment group, and compared for differences between treatment groups.|1 year post-operatively|There were 6 screen fails and 10 enrolled subjects who did not complete the study. Fifteen patients who were screened, consented, and enrolled, completed the 2-year study. Five patients who completed the study were assigned to the MSP treatment group and ten were assigned to the BioCartilage treatment group.|||Participants|||Count of Participants
2597110|NCT02202044|Secondary|To Compare Complete Response Rates at 3 and 6 Months in Patients With Carcinoma in Situ.||5 years|The study was terminated before participants finished treatment and the PI is no longer in the institution to provide information for results reporting. No results information is available.||||||
2596940|NCT02203032|Secondary|Number of Visits at Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 90 Response From Week 28 Through Week 40|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.|Week 28 through Week 40|Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.|||visits||Standard Deviation|Mean
2596941|NCT02203032|Primary|Number of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40|The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).|Week 28 through Week 40|Randomized population included all enrolled participants with IGA >=2 at Week 16 randomly assigned to 1 of the 2 treatment regimens (guselkumab or ustekinumab) at Week 16.|||visits||Standard Deviation|Mean
2596942|NCT02203019|Secondary|Mortality|Number of patients who die within 28 days after randomization|Up to 28 Days||||Participants|||Count of Participants
2596943|NCT02203019|Secondary|Duration of Vasopressor Support|Number of days the patient requires intravenous vasopressors|Up to 28 Days||||days||Inter-Quartile Range|Median
2596944|NCT02203019|Secondary|Duration of MICU Stay|Number of days patient stays in the MICU|Up to 28 Days||||days||Inter-Quartile Range|Median
2596945|NCT02203019|Primary|Duration of Mechanical Ventilation|Number of days patient requires mechanical ventilation|Up to 28 days||||days||Inter-Quartile Range|Median
2596946|NCT02202980|Secondary|Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit||Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2596947|NCT02202980|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug|||percentage of participants|||Number
2596948|NCT02202980|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2596949|NCT02202980|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug|||percentage of participants|||Number
2596950|NCT02202980|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2596951|NCT02202850|Secondary|Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) at Month 6 and 12|ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.|Baseline, Month 6 and 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.|||Units on a scale||Standard Deviation|Mean
2596952|NCT02202850|Secondary|Change From Baseline in Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) at Month 6 and 12|ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.|Baseline, Month 6 and 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.|||Units on a scale||Standard Deviation|Mean
2597525|NCT02196714|Primary|T 1/2|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (T 1/2)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||h||Full Range|Mean
2596953|NCT02202850|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Month 6 and 12|BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity.|Baseline, Month 6 and 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.|||Units on a scale||Standard Deviation|Mean
2596954|NCT02202850|Secondary|Change From Baseline in Spinal Mobility Measurement at Month 6 and 12|Spinal mobility was the mean of right and left measurements of lateral spinal flexion in centimeters.|Baseline, Month 6 and 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.|||centimeters||Standard Deviation|Mean
2596955|NCT02202850|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Month 6 and 12|CRP is a protein marker in the blood for inflammation.|Baseline, Month 6 and 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.|||milligrams per liter||Standard Deviation|Mean
2596956|NCT02202850|Secondary|Change From Baseline in Inflammation Score of Ankylosing Spondylitis at Month 6 and 12|Inflammation score is used to determine disease activity in participants with AS by measuring intensity and duration of inflammation, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of inflammation. The total inflammation score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of inflammation in participant due to AS.|Baseline, Month 6 and12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.|||Units on a scale||Standard Deviation|Mean
2596957|NCT02202850|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Month 6 and 12|BASFI was a functional index which included 10 items assessing ability of participants to perform normal daily activities. Each item was scored on a scale of 0=easy, to 10=impossible. The BASFI total score was calculated as the average score of these 10 individual items. BASFI total score ranged from 0 to 10, where higher scores indicated more severe disease activity.|Baseline, Month 6 and 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.|||Units on a scale||Standard Deviation|Mean
2596958|NCT02202850|Secondary|Change From Baseline in Pain Score of Ankylosing Spondylitis at Month 6 and 12|Pain score is used to determine disease activity in participants with AS by measuring participants pain and swelling, on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/swelling. The total pain score was calculated as average of these 2 items and ranged from 0= none to 10= severe, where higher score indicated higher degree of pain in participant due to AS.|Baseline, Month 6 and 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.|||Units on a scale||Standard Deviation|Mean
2596959|NCT02202850|Secondary|Change From Baseline in Participant Global Assessment (PGA) Score at Month 6 and 12|Participants were asked to assess their disease activity on an 11-point scale of 0 (no disease activity) to 10 (extreme disease activity), where higher score indicated higher disease activity.|Baseline, Month 6 and 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.|||Units on a scale||Standard Deviation|Mean
2596960|NCT02202850|Secondary|Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 3, 6, 9 and 12|ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.|Month 3, 6, 9 and 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.|||percentage of participants||95% Confidence Interval|Number
2596961|NCT02202850|Secondary|Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 3, 6, 9 and 12|ASDAS-CRP was based on 3 domains: BASDAI, BAS-G and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.|Month 3, 6, 9 and 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.|||percentage of participants||95% Confidence Interval|Number
2597111|NCT02202044|Primary|To Assess Disease Recurrence Rate||5 years|The study was terminated before participants finished treatment and the PI is no longer in the institution to provide information for results reporting. No results information is available.||||||
2596962|NCT02202850|Secondary|Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 3, 6, 9 and 12|BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least >=50 percent relative improvement from baseline in BASDAI total score.|Month 3, 6, 9 and 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.|||percentage of participants||95% Confidence Interval|Number
2596963|NCT02202850|Secondary|Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 3, 6, 9 and 12|ASAS 40 was defined as at least >= 40 percent relative improvement from baseline and an absolute change >=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).|Month 3, 6, 9 and 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.|||percentage of participants||95% Confidence Interval|Number
2596964|NCT02202850|Secondary|Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 3, 6, 9 and 12|ASAS 60 was defined as at least >= 60 percent relative improvement from baseline and an absolute change >=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).|Month 3, 6, 9 and 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.|||percentage of participants||95% Confidence Interval|Number
2596965|NCT02202850|Secondary|Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 3, 6, 9 and 12|ASAS 5/6 was defined as at least >= 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, CRP and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in mg/L and spinal mobility was measured in centimeter as calculated as the mean of right and left measurements of lateral spinal flexion.|Month 3, 6, 9 and 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.|||percentage of participants||95% Confidence Interval|Number
2596966|NCT02202850|Secondary|Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission Criteria at Month 3, 6, 9 and 12|ASAS partial remission was defined as a score of <= 2 for each of the 4 items including pain, function, PGA and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.|Month 3, 6, 9 and 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort.|||percentage of participants||95% Confidence Interval|Number
2596967|NCT02202850|Primary|Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on Erythrocyte Sedimentation Rate (ASDAS-ESR) Remission Criteria at Month 6 and Maintained Till Month 12|ASDAS-ESR was based on 3 domains: BASDAI, BAS-G and ESR (in millimeter per hour). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS- ESR total scores. ASDAS- ESR remission was defined as having total ASDAS- ESR score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.|Month 6 up to Month 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2596968|NCT02202850|Primary|Percentage of Participants Who Achieved the Ankylosing Spondylitis Disease Activity Score Based on C-Reactive Protein (ASDAS-CRP) Remission Criteria at Month 6 and Maintained Till Month 12|ASDAS-CRP was based on 3 domains: BASDAI, Bath Ankylosing Spondylitis Global score (BAS-G) and CRP (in mg/L). BASDAI was used to measure disease activity by measuring participant's pain, discomfort and inflammation on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated lesser movement of participant due to AS. BAS-G was used to measure spinal pain on a scale ranging from 0= none to 10= severe, where higher scores indicated worsen health status. Scores from these 3 individual domains were averaged to calculate the ASDAS-CRP total scores. ASDAS-CRP remission was defined as having total ASDAS-CRP score of <1.3 on a scale ranging from 0= none to 10= severe, where higher scores indicated higher disease activity.|Month 6 up to Month 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2597004|NCT02202785|Secondary|Overall Survival (OS)|Overall survival is defined as the time in days from the date of first study drug administration to the date of death.|Until death or 6 months after the last patient completes treatment—whichever occurs first (Up to 16 months)|Safety population included all participants who received any amount of MLN0264.|||days||Full Range|Median
2596969|NCT02202850|Primary|Percentage of Participants Who Achieved the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Remission Criteria at Month 6 and Maintained Till Month 12|BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS by measuring participant's pain, discomfort and inflammation. Participant's pain, discomfort and inflammation was measured on a scale ranging from 0= none to 10= severe, where higher scores indicated higher degree of pain/discomfort/inflammation. The total BASDAI score was calculated as average of individual scores and ranged from 0= none to 10= severe, where higher score indicated high disease activity. BASDAI 50 remission was defined as at least >=50 percent relative improvement from baseline in BASDAI total score.|Month 6 up to Month 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2596970|NCT02202850|Primary|Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 40 Remission Criteria at Month 6 and Maintained Till Month 12|ASAS 40 was defined as at least >= 40 percent relative improvement from baseline and an absolute change >=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).|Month 6 up to Month 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2596971|NCT02202850|Primary|Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 60 Remission Criteria at Month 6 and Maintained Till Month 12|ASAS 60 was defined as at least >= 60 percent relative improvement from baseline and an absolute change >=2 scores in 3 of the 4 following items: PGA, pain, function, inflammation (where all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity) and no worsening in the remaining 2 domains: CRP (mg/L) and spinal mobility (cm).|Month 6 up to Month 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2596972|NCT02202850|Primary|Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 5/6 Remission Criteria at Month 6 and Maintained Till Month 12|ASAS 5/6 was defined as at least greater than or equal to (>=) 20 percent relative improvement from baseline in at least 5 of the 6 following items: PGA, pain, function, inflammation, C - reactive protein (CRP) and spinal mobility. PGA, pain, function, inflammation all were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity. CRP was measured in milligrams per liter (mg/L) and spinal mobility was measured in centimeter (cm) as calculated as the mean of right and left measurements of lateral spinal flexion.|Month 6 up to Month 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2596973|NCT02202850|Primary|Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) Partial Remission at Month 6 and Maintained Till Month 12|ASAS partial remission was defined as a score of less than or equal to (<=) 2 for each of the 4 items including pain, function, participant global assessment (PGA) and inflammation. All these items were measured on a scale ranging from 0-10, where 0= no disease activity and 10= high disease activity.|Month 6 up to Month 12|Completers analysis data set included all participants enrolled in the study, who completed the 12-month study, whether or not they missed some follow-up visits, and regardless of the cohort. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2596974|NCT02202837|Secondary|Change From Baseline in Seven-Joint Ultrasound (US7) Erosion Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12|US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. GSUS was a scoring system used to determine the erosions. The joints were examined by GSUS for erosions from a dorsal, palmar/plantar and radial/lateral (only MCP 2 and MTP 5) aspect. The US7 erosion sum score in GSUS was the sum of the 14 following scores (MCP 2 dorsal, MCP 2 palmar, MCP 2 radial, MCP 3 dorsal, MCP 3 palmar, PIP 2 dorsal, PIP 2 palmar, PIP 3 dorsal, PIP 3 palmar, MTP 2 dorsal, MTP 2 plantar, MTP 5 dorsal, MTP 5 plantar and MTP 5 lateral) ranging from 0 to 1. Total score ranged from 0 (no erosions) to 14 (severe erosions), higher score= more erosions. The score was based on measurements made at fingers and toes and were calculated for both left and right sides, the score of the clinically most affected side.|Month 6 and Month 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||units on a scale||Standard Deviation|Mean
2596975|NCT02202837|Secondary|Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12|US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis and tenosynovitis/paratenonitis) and destructive processes (erosions) in a single scoring system. PDUS assessed the degree of synovial inflammation of the joints of both hands. The joints were examined by PDUS from a dorsal and palmar aspect. The US7 tenosynovitis/paratenonitis sum score in PDUS was the sum of the scores for 7 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 dorsal, MCP 2 palmar, MCP 3 dorsal, MCP 3 palmar) on a scale ranging from 0 =no synovitis to 1=severe synovitis. Total US7 tenosynovitis/paratenonitis PDUS score ranged from 0 (no synovitis) to 7 (severe synovitis), higher score= more synovitis.|Baseline, Month 6 and Month 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||units on a scale||Standard Deviation|Mean
2596976|NCT02202837|Secondary|Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12|US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis and tenosynovitis/paratenonitis) and destructive processes (erosions) in a single scoring system. GSUS was a scoring system used to determine the tenosynovitis/paratenonitis. The joints were examined by GSUS from a dorsal and palmar aspect. The US7 tenosynovitis/paratenonitis sum score in GSUS was the sum of the scores for 7 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 dorsal, MCP I2 palmar, MCP 3 dorsal, MCP 3 palmar) on a scale ranging from 0 =no synovitis to 1=severe synovitis. Total US7 tenosynovitis/paratenonitis GSUS score ranged from 0 (no synovitis) to 7 (severe synovitis), higher score= more synovitis.|Baseline, Month 6 and Month 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||units on a scale||Standard Deviation|Mean
2596977|NCT02202837|Secondary|Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12|US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. PDUS assessed the degree of synovial inflammation of the joints of both hands. The joints were examined by PDUS from a dorsal and palmar aspect. The US7 synovitis sum score in PDUS was the sum of the scores of 13 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 palmar, MCP 2 dorsal, MCP 3 palmar, MCP 3 dorsal, PIP 2 palmar, PIP 2 dorsal, PIP 3 palmar, PIP 3 dorsal, MTP 2 dorsal, MTP 5 dorsal) on a scale ranging from 0=no intraarticular color signal to 3 = >=50% of the intraarticular area filled with color signals. Total US7 PSUS scores ranges from 0=no intraarticular color signal to 39 = >=50% of the intraarticular area filled with color signals; higher scores= more severe disease.|Baseline, Month 6 and Month 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||units on a scale||Standard Deviation|Mean
2596978|NCT02202837|Secondary|Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12|US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. GSUS is a scoring system use to determine synovitis. The joints were examined by GSUS for synovitis from a dorsal and palmar aspect. The US7 synovitis sum score in GSUS was the sum of the scores for 9 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 palmar, MCP 3 palmar, PIP 2 palmar, PIP 3 palmar, MTP 2 dorsal, MTP 5 dorsal) on a scale ranging from 0 =no synovitis to 3=severe synovitis. Total US7 GSUS score ranged from 0 (no synovitis) to 27 (severe synovitis), higher score= more synovitis.|Baseline, Month 6 and Month 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||units on a scale||Standard Deviation|Mean
2596979|NCT02202837|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6 and 12|The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.|Baseline, Month 6 and Month 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||units on a scale||Standard Deviation|Mean
2596980|NCT02202837|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) at Month 6 and 12|The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI >3.4 to 11 implied low disease activity, >11 to 26 implied moderate disease activity, >26 implied high disease activity and <=3.3 implied disease remission.|Baseline, Month 6 and Month 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||units on a scale||Standard Deviation|Mean
2596981|NCT02202837|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Month 6 and 12|DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from SJC and TJC using 28 joints count, CRP (mg/L) or ESR (mm/hr) levels and PGA of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 <=3.2 implied low disease activity and > 3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28 <2.6 implied remission.|Baseline, Month 6 and Month 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||units on a scale||Standard Deviation|Mean
2597015|NCT02202759|Secondary|Serum Concentration of Total Antibodies (Conjugated and Unconjugated)|Blood samples were collected and sent to a laboratory to be tested for conjugated and unconjugated antibodies.|Cycles 1-3 pre-dose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days post-dose; Cycles 4-9 and 11-14 pre-dose and 10 minutes post-dose; End of Treatment.|"PK-Evaluable population included all participants who received at least 1 dose of MLN0264 and who had sufficient MLN0264 concentration−time data to permit reliable estimation of MLN0264 exposure. n in the categories is the number of participants with data available at the given time-point."|||μg/mL||Standard Deviation|Mean
2597140|NCT02201940|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12||Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2596982|NCT02202837|Secondary|Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Month 12|Remission based on DAS28 + US7: DAS28 <2.6 and US7 synovitis sum score in GSUS=0, PDUS=0 and US7 erosion sum score in GSUS=0. DAS28: SJC + TJC in 28 joints count + CRP(mg/L) or ESR(mm/hr) levels and PGA on 0-100 mm scale (0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). U7 Remission: US7 synovitis sum score in GSUS=0, PDUS=0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions(synovitis) and destructive processes(erosions) in single scoring system. US7 score included MKUS examination of given joints: wrist, MCP II and III, PIP II and III, MTP II and V. Joints were examined by GSUS and PDUS for synovitis on scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = >=50% of intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on binary basis 0 (no remission) and 1 (remission).|Month 6 and 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
2596983|NCT02202837|Secondary|Percentage of Participants With no Signs of Ultrasound Synovitis (Ultrasound Remission) at Month 6 and 12|A participant was in remission based on US7: if US7 synovitis sum score in GSUS =0, PDUS =0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. US7 score included MKUS examination of the following joints of the more clinically affected side: wrist, MCP II and III, PIP II and III, MTP II and V. The joints were examined by GSUS and PDUS for synovitis. Synovitis in GSUS and PDUS was analyzed on a scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = >=50% of the intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on a binary basis 0 and 1 where 0=no remission and remission=1.|Month 6 and 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
2596984|NCT02202837|Secondary|Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion at Month 3, 6, 9 and 12|The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) <=1; SJC (in 28 joints) <=1 and PGA<=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).|Month 3, 6, 9 and 12|The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention).|||percentage of participants||95% Confidence Interval|Number
2596985|NCT02202837|Secondary|Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion at Month 3, 6, 9 and 12|The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) <=1; SJC (in 28 joints) <=1; CRP<=1 mg/dl; PGA<=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).|Month 3, 6, 9 and 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
2596986|NCT02202837|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 3, 6, 9 and 12|The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.|Month 3, 6, 9 and 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
2596987|NCT02202837|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) <=3.3 at Month 3, 6, 9 and 12|The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI >3.4 to 11 implied low disease activity, >11 to 26 implied moderate disease activity, >26 implied high disease activity and <=3.3 implied disease remission.|Month 3, 6, 9 and 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
2597016|NCT02202759|Secondary|MLN0264 Serum Concentrations|Blood samples were collected and sent to a laboratory to be tested for serum concentrations of MLN0264.|Cycles 1-3 pre-dose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days post-dose; Cycles 4-9 and 11-14 pre-dose and 10 minutes post-dose; End of Treatment.|"Pharmacokinetic (PK)-Evaluable population included all participants who received at least 1 dose of MLN0264 and who had sufficient MLN0264 concentration−time data to permit reliable estimation of MLN0264 exposure. n in the categories is the number of participants with data available at the given time-point."|||μg/mL||Standard Deviation|Mean
2597045|NCT02202434|Other Pre-specified|Percentage of Participants With Prosthetic Aortic Valve Thrombosis|Prosthetic aortic valve thrombosis|assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.|Intent to Treat|||Percentage of participants|||Number
2596988|NCT02202837|Secondary|Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) <2.6 at Month 3, 6, 9 and 12|DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from SJC and TJC using 28 joints count, CRP (mg/L) or ESR) (mm/hr) levels and PGA of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 <=3.2 implied low disease activity and > 3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28 <2.6 implied remission.|Month 3, 6, 9 and 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
2596989|NCT02202837|Primary|Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Maintained Till Month 12|Remission based on DAS28 + US7: DAS28 <2.6 and US7 synovitis sum score in GSUS=0, PDUS=0 and US7 erosion sum score in GSUS=0. DAS28: SJC + TJC in 28 joints count + CRP(mg/L) or ESR(mm/hr) levels and PGA on 0-100 mm scale (0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). U7 Remission: US7 synovitis sum score in GSUS=0, PDUS=0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions(synovitis) and destructive processes(erosions) in single scoring system. US7 score included MKUS examination of given joints: wrist, MCP II and III, PIP II and III, MTP II and V. Joints were examined by GSUS and PDUS for synovitis on scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = >=50% of intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on binary basis 0 (no remission) and 1 (remission).|Month 6 up to Month 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
2596990|NCT02202837|Primary|Percentage of Participants With Remission Based on Seven-Joint Ultrasound (US7) Measurements at Month 6 and Maintained Till Month 12|A participant was in remission based on US7: if US7 synovitis sum score in grey-scale Ultrasonography (GSUS) =0, Power Doppler Ultrasonography (PDUS) =0 and erosion sum score in GSUS=0. US7 score is musculoskeletal ultrasonography (MKUS) composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. US7 score included MKUS examination of the following joints of the more clinically affected side: wrist, metacarpophalangeal (MCP) II and III, proximal interphalangeal (PIP) II and III, metatarsophalangeal (MTP) II and V. The joints were examined by GSUS and PDUS for synovitis. Synovitis in GSUS and PDUS was analyzed on a scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = >=50% of the intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on a binary basis 0 and 1 where 0=no remission and remission=1.|Month 6 up to Month 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
2596991|NCT02202837|Primary|Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion|The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) <=1; SJC (in 28 joints) <=1 and PGA<=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).|Month 6 up to Month 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
2596992|NCT02202837|Primary|Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion|The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) <=1; SJC (in 28 joints) <=1; CRP<=1 mg/dl; PGA<=1 (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition).|Month 6 up to Month 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
2596993|NCT02202837|Primary|Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 6 and Maintained Till Month 12|The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.|Month 6 up to Month 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
2597017|NCT02202759|Secondary|Cmax: Maximum Observed Serum Concentration for MLN0264|Maximum observed serum concentration (Cmax) is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve.|Cycles 1-3 predose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days postdose. Cycles 4+ predose, 10 minutes, 4 hours, and 4 and 8 days postdose.|Cmax was not a pre-specified secondary outcome measure. No data was collected.||||||
2596994|NCT02202837|Primary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 at Month 6 and Maintained Till Month 12|The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, physician (evaluator) global assessment of disease (EGA) and PGA (assessed on a 0 mm [very well] to 10 mm [extremely bad] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI >3.4 to 11 implied low disease activity, >11 to 26 implied moderate disease activity, >26 implied high disease activity and <=3.3 implied disease remission.|Month 6 up to Month 12|"The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
2596995|NCT02202837|Primary|Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) Less Than (<) 2.6 at Month 6 and Maintained Till Month 12|DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, C-reactive protein (CRP) (milligrams per liter [mg/L]) or erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) levels and patient global assessment (PGA) of disease activity on a 0-100 mm scale (scores ranging from 0 mm [very well] to 100 mm [extremely bad], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 [less than or equal to] <=3.2 implied low disease activity and greater than (>) 3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28 less than (<) 2.6 implied remission.|Month 6 up to Month 12|"The completers analysis data set (CAS) consisted of all participants enrolled in study and who completed 12-month study, whether or not they missed some follow-up visits and regardless of cohort (first or second intention). Here, N (number of participants analyzed) signifies participants who were evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
2596996|NCT02202785|Secondary|Number of Participants With Antitherapeutic Antibodies (ATA)|Blood samples were collected to assess the immunogenicity of MLN0264 (ATA development) using a laboratory test. Neutralizing ATA assessment was performed for ATA-positive samples only.|Pre-dose of each 21 day cycle and 30 days after last dose of study medication (Up to 7.9 months)|Safety Population included all participant who received any amount of MLN0264.|||Participants|||Number
2596997|NCT02202785|Secondary|Percentage of Participants With Reduction From Baseline in Tumor Size|The percentage of participants with the best percentage of tumor reduction from baseline in the sum of the diameter was calculated|Day 21 of each 21-day cycle, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Approximately 13.9 months)|Response-Evaluable Population was defined as all participants with measurable disease who receive at least 1 dose of MLN0264 and have at least 1 post-baseline response assessment.|||percentage of participants|||Number
2596998|NCT02202785|Secondary|Serum Concentration of Total Antibodies (Conjugated and Unconjugated)|Blood samples were collected and sent to a laboratory to be tested for conjugated and unconjugated antibodies.|Cycles 1-3 predose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days postdose. Cycles 4+ predose, 10 minutes, 4 hours, and 4 and 8 days postdose.|"PK-Evaluable population included all participants who received at least 1 dose of MLN0264 and who have sufficient MLN0264 concentration−time data to permit reliable estimation of MLN0264 exposure.n in the categories is the number of participants with data available at the given time-point."|||μg/mL||Standard Deviation|Mean
2596999|NCT02202785|Secondary|MLN0264 Serum Concentrations|Blood samples were collected and sent to a laboratory to be tested for serum concentrations of MLN0264.|Cycles 1-3 predose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days postdose. Cycles 4+ predose, 10 minutes, 4 hours, and 4 and 8 days postdose.|"Pharmacokinetic (PK)-Evaluable population included all participants who received at least 1 dose of MLN0264 and who have sufficient MLN0264 concentration−time data to permit reliable estimation of MLN0264 exposure. n in the categories is the number of participants with data available at the given time-point."|||μg/mL||Standard Deviation|Mean
2597000|NCT02202785|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.|From the first dose through 30 days after the last dose of study medication (Up to 7.9 months)|Safety population included all participants who received any amount of MLN0264.|||Participants|||Number
2597001|NCT02202785|Secondary|Guanylyl Cyclase C (GCC) H-score Assessed by Immunohistochemistry (IHC)|GCC H-score is based on the sum of the 0 to 300 H-score for cytoplasmic staining and the 0 to 300 H-score for apical staining for a total possible H-score 0 to 600. Separate consent is required to obtain archival tumor specimens for GCC expression assessment prior to screening.|From pre-screening through end of study (approximately 18 months)|Safety population included all participants who received any amount of MLN0264.|||scores on a scale||Full Range|Mean
2597002|NCT02202785|Secondary|Serum Concentration of Monomethyl Auristatin E (MMAE)|Blood samples were collected and sent to a laboratory to be tested for MMAE.|Cycles 1-3 predose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days postdose. Cycles 4+ predose, 10 minutes, 4 hours, and 4 and 8 days postdose.|"PK-Evaluable population included all participants who received at least 1 dose of MLN0264 and who have sufficient MLN0264 concentration−time data to permit reliable estimation of MLN0264 exposure. n in the categories is the number of participants with data available at the given time-point."|||ng/mL||Standard Deviation|Mean
2597003|NCT02202785|Secondary|Cmax: Maximum Observed Serum Concentration for MLN0264||Cycles 1-3 predose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days postdose. Cycles 4+ predose, 10 minutes, 4 hours, and 4 and 8 days postdose.|Cmax was not a pre-specified secondary outcome measure. No data was collected.||||||
2597141|NCT02201940|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12||Weeks 1, 2, 4, 6, 8, 10, and 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2597005|NCT02202785|Secondary|Disease Control Rate|Disease control rate is defined as the percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) with a minimum of 12 weeks' duration. Investigator response is based on the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started.|Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 13.9 months)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment.|||percentage of participants|||Number
2597006|NCT02202785|Secondary|Duration of Response|Duration of response is defined as the time from the date of first documentation of a Partial Response or better to the date of first documentation of disease progression or relapse based on investigator assessment using RECIST version 1.1 guidelines. Per RECIST version 1.1 for target lesions and assessed by MRI: CR, Disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions.|From first documented response until disease progression (Up to 16 months)|Participants from the Response-Evaluable population, all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment, who had a response.|||days||Full Range|Median
2597007|NCT02202785|Secondary|Progression Free Survival (PFS)|PFS is defined as the time in days from the date of first study drug administration to the date of first documentation of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 13.9 months)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment.|||days||Full Range|Median
2597008|NCT02202785|Secondary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Participants with at least one potentially clinically significant post-baseline vital sign finding including measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.|Day 1 of each 21 day cycle and 30 days after the last dose of study medication (Up to 7.9 months)|Safety population included all participants who received any amount of MLN0264.|||Participants|||Number
2597009|NCT02202785|Secondary|Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings|Participants with at least one post-baseline potentially clinically significant serum chemistry, hematology, coagulation or urinalysis result. Clinically significant results are those that were assessed by the investigator to be Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death.|Day 1 of each 21 day cycle and 30 days after the last dose of study medication (Up to 7.9 months)|Safety population included all participants who received any amount of MLN0264.|||Participants|||Number
2597010|NCT02202785|Primary|Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST)|ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.|Day 21, every other cycle, starting with Cycle 2 until disease progression, death or study closure (Up to 16 months)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment.|||percentage of participants|||Number
2597011|NCT02202759|Secondary|Number of Participants With Antitherapeutic Antibodies (ATA)|Blood samples were collected to assess the immunogenicity of MLN0264 (ATA development) using a laboratory test. Neutralizing ATA assessment was performed for ATA-positive samples only.|Pre-dose of each 21 day cycle and 30 days after last dose of study medication (Up to 10.7 months)|Safety Population included all participant who received any amount of MLN0264.|||participants|||Number
2597012|NCT02202759|Secondary|Guanylyl Cyclase C (GCC) H-score Assessed by Immunohistochemistry (IHC)|Analysis of GCC protein expression levels in tumor tissue (fresh biopsy pretreatment and whenever a biopsy is considered medically safe and technically feasible) was performed using a semiquantitative immunohistochemistry (IHC) assay and the total GCC H-Score was determined. GCC H-score is based on the sum of the 0 to 300 H-score for cytoplasmic staining and the 0 to 300 H-score for apical staining for a total possible H-score 0 to 600. Separate consent was required to obtain archival tumor specimens for GCC expression assessment prior to screening.|Approximately 20 months|Safety population included all participants who received any amount of MLN0264.|||scores on a scale||Full Range|Mean
2597013|NCT02202759|Secondary|Number of Participants With Reduction From Baseline in Tumor Size|The number of participants with the best percentage of tumor reduction from baseline in the sum of the diameter was calculated.|Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 16.7 months)|Response-Evaluable Population was defined as all participants with measurable disease who receive at least 1 dose of MLN0264 and have at least 1 postbaseline response assessment.|||participants|||Number
2597014|NCT02202759|Secondary|Serum Concentration of Monomethyl Auristatin E (MMAE)|Blood samples were collected and sent to a laboratory to be tested for MMAE.|Cycles 1-3 pre-dose and 10 minutes, 4 hours, and 3, 4, 8 and 15 days post-dose; Cycles 4-9 and 11-14 pre-dose and 10 minutes post-dose; End of Treatment.|"PK-Evaluable population included all participants who received at least 1 dose of MLN0264 and who had sufficient MLN0264 concentration−time data to permit reliable estimation of MLN0264 exposure. n in the categories is the number of participants with data available at the given time-point."|||ng/mL||Standard Deviation|Mean
2597019|NCT02202759|Secondary|Disease Control Rate|Disease control rate is defined as the percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) with a minimum of 12 weeks' duration. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the Longest Diameter (LD) of target lesions, taking as reference the baseline sum LD and no new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) of target lesions, taking as reference the smallest sum LD since the treatment started and no new lesions. Investigator response is based on the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.|Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 16.7 months)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment.|||percentage of participants|||Number
2597020|NCT02202759|Secondary|Duration of Response|Duration of response is defined as the time in days from the date of first documentation of a confirmed response to the date of first documentation of disease progression. Per RECIST v1.1 for target lesions and assessed by magnetic resonance imaging (MRI) - CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.|From first documented response until disease progression (Up to 16.7 months)|Participants from the Response-Evaluable population, all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment, who had response.|||days||Full Range|Median
2597021|NCT02202759|Secondary|Progression Free Survival (PFS)|PFS is defined as the time in days from the date of first study drug administration to the date of first documentation of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Time Frame: Day 21 of every other 21-day cycle starting with Cycle 2, 30 days after the last dose of study medication, and then every 12 weeks for up to an additional 6 months (Up to 16.7 months)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment.|||days||Full Range|Median
2597022|NCT02202759|Secondary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Participants with at least one potentially clinically significant post-baseline vital sign finding including measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.|Day 1 of each 21 day cycle and 30 days after the last dose of study medication (Up to 10.7 months)|Safety population included all participants who received any amount of MLN0264.|||participants|||Number
2597023|NCT02202759|Secondary|Number of Participants With Potentially Clinically Significant Laboratory Evaluation Findings|Participants with at least one post-baseline potentially clinically significant serum chemistry, hematology, coagulation or urinalysis result. Clinically significant results are those that were assessed by the investigator to be Grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE). Grade 3=severe, Grade 4=life threatening or disabling and Grade 5=Death.|From the first dose through 30 days after the last dose of study medication (Up to 10.7 months)|Safety population included all participants who received any amount of MLN0264.|||participants|||Number
2597024|NCT02202759|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug will be determined by the Investigator.|From the first dose through 30 days after the last dose of study medication (Up to 10.7 months)|Safety population included all participants who received any amount of MLN0264.|||participants|||Number
2597025|NCT02202759|Primary|Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST)|ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.|Day 21, every other cycle, starting with Cycle 2 until disease progression, death or study closure (up to 17 months)|Response-Evaluable population included all participants with measurable disease who received at least 1 dose of MLN0264 and had at least 1 post-baseline response assessment.|||percentage of participants|||Number
2597026|NCT02202616|Secondary|Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Questionnaire (CAT)|The CAT is an 8 item questionnaire that assesses the impact of COPD on the patient's functional status. Scores for each of the 8 items are summed to give an overall score (out of 40). The score ranges from 0-40 where higher scores represent worse health status. CAT scores ≥ 10 are associated with significantly impaired health status.|Baseline, week 4, week 16|Intent to treat set (ITT)- included all patients who received the study treatment and returned for ≥ 1 post baseline visit|||Score||Standard Deviation|Mean
2597027|NCT02202616|Secondary|Single Point and Change in Baseline Dyspnea Index and Transitional Dyspnea Index (BDI/TDI)|A trained assessor interviewed the patient and graded the degree of impairment due to dyspnea (difficulty breathing). BDI/TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. The BDI was assessed at Baseline, whereas the TDI was assessed at Week 4 and Week 16.|Baseline, Week 4, week 16|Intent to treat set (ITT)- included all patients who received the study treatment and returned for ≥ 1 post baseline visit|||Score||Standard Deviation|Mean
2597028|NCT02202616|Secondary|Change From Baseline in Trough FEV1 (Forced Expiratory Volume) to Week 4|Portable spirometers will be provided to investigators and they will use this device for all of their patient measurements of FEV1 during the trial|Baseline, week 4|Intent to treat set (ITT)- included all patients who received the study treatment and returned for ≥ 1 post baseline visit|||Liter||Standard Deviation|Mean
2597029|NCT02202616|Primary|Change From Baseline in Trough (Forced Expiratory Volume (FEV1) (Pre-dose FEV1)|Primary end points: To evaluate the real-life effectiveness of QVA149 (indacaterol 110 mcg/glycopyrronium 50 mcg) in the management of patients with COPD who have symptoms defined as CAT score >10 with tiotropium monotherapy; effectiveness will be assessed as the mean change in trough FEV1 from baseline to 16 weeks. and to evaluate the real-life effectiveness of QVA149 (indacaterol 110 mcg/glycopyrronium 50 mcg) in the management of patients with COPD who have symptoms defined as CAT score >10 while on treatment with FDC of fluticasone propionate/salmeterol; effectiveness will be assessed as the mean change in trough FEV1 from baseline to 16 weeks.|16 weeks study|Intent to treat set (ITT)- included all patients who received the study treatment and returned for ≥ 1 post baseline visit|||Liter||Standard Deviation|Mean
2597030|NCT02202538|Secondary|Borg Rating of Perceived Exertion (BRPE) for Walking Indoors|"The BPRE characterizes the level of effort required by an individual to perform a task and takes into account both the person's fitness level and the difficulty of the task.~6: no exertion at all 7: extremely light 8-9: very light 10-11: light 12-13: somewhat hard 14-15: hard (heavy) 16-17: very hard 18-19: extremely hard 20: maximal exertion"|8 weeks||||units on a scale||Standard Deviation|Mean
2597031|NCT02202538|Secondary|Functional Independence Measure (FIM) Score for Walking Indoors|"FIM measures an individual's level of disability and indicates how much assistance is needed for that individual to carry out activities of daily living.~7: complete independence 6: modified independence 5: supervision or setup assistance 4: minimal contact assistance 3: moderate assistance 2: maximal assistance~1: total assistance~Reference: rehabmeasures.org"|8 weeks||||units on a scale||Standard Deviation|Mean
2597032|NCT02202538|Secondary|Walking Index for Spinal Cord Injury (WISCI-II) Assessment|"Assesses physical assistance and devices required for persons to walk following paralysis resulting from a Spinal Cord Injury.~0:unable~parallel bars, braces, help of 2 persons,<10m~parallel bars, braces, help of 2 persons,10m~parallel bars, braces, help of 1 person,10m~parallel bars, no braces, help of 1 person,10m~parallel bars, braces, no help,10m~walker, braces, help of 1 person,10m 7:2 crutches, braces, help of 1 person,10m~8:walker, no braces, help of 1 person,10m 9:walker, braces, no help,10m 10:1 cane/crutch, braces, help of 1 person,10m 11:2 crutches, no braces, help of 1 person,10m 12:2 crutches, braces, no help,10m 13:walker, no braces/help,10m 14:1 cane/crutch, no braces, help of 1 person,10m 15:1 cane/crutch, braces, no help,10m 16:2 crutches, no braces/help,10m 17:no devices/braces, help of 1 person,10m 18: no devices, braces, no help,10m 19:1cane/crutch, no braces/help,10m 20:no devices/braces/help,10m~Reference: rehabmeasures.org"|8 weeks||||units on a scale||Standard Deviation|Mean
2597033|NCT02202538|Primary|Percentage of Subjects That Could Don/Doff the Device Independently|The percentage of participants that could don/doff the device independently at the end of the study, without the help of their Physical Therapist.|8 weeks||||percentage|||Number
2597034|NCT02202538|Primary|Average Time to Don/Doff Device|Time needed for an individual to don or doff the device.|8 weeks||||minutes||Standard Deviation|Mean
2597035|NCT02202538|Primary|Timed Up and Go (TUG) Test|Measures the time required for an individual to stand from a seated position, walk three meters, turn, walk back three meters, turn and return to a seated position.|8 weeks||||seconds||Standard Deviation|Mean
2597036|NCT02202538|Primary|Average Speed of 10 Meter Walk Test (10MWT) Mid Study Versus End of Study|Measured time for an individual to complete walking 10 meters with the Indego and a stability aid midway through the study and at the end of the study.|4 weeks, 8 weeks||||meters/second||Standard Deviation|Mean
2597037|NCT02202538|Primary|Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT)|Measured time for an individual to complete walking 600 meters on a level surface with the Indego and stability aid at the end of the study, proposed to be representative of an individual's ability to ambulate in the community.|8 weeks||||percentage of participants|||Number
2597038|NCT02202499|Secondary|Mean Smoking Satisfaction Score Per Group|"Smoking satisfaction per day by treatment group, using 11-point Likert scale, 0-10. 0 was none, 5 medium and 10 very high"|Across 4 pre-quit weeks|All participants.|||units on a scale||Standard Error|Mean
2597039|NCT02202499|Secondary|Mean Peak Craving Score Per Group|"Peak craving per day by treatment group, scored using an 11-point Likert scale 0-10. 0 was none, 5 medium and 10 very high/strong"|Across 4 pre-quit weeks|All participants.|||units on a scale||Standard Error|Mean
2597040|NCT02202499|Secondary|Average Intervention Adherence - Cigarettes Per Day (CPD)|Average Cigarettes per Day across group, during last week of treatment.|During last week of treatment, week 16|All participants.|||cigarettes per day||Standard Deviation|Mean
2597041|NCT02202499|Secondary|Rate of Intervention Adherence - Medication|Percent of participants still using varenicline at time of analysis.|One month post treatment - approximately 20 weeks|All participants.|||percentage of participants|||Number
2597042|NCT02202499|Secondary|Client Satisfaction Questionnaire (CSQ) Results|Acceptability: Mean score of Client Satisfaction Questionnaire (CSQ) version 8 by Attkison & Greenfield. Questionnaire scores client satisfaction with a scale of 1-4 per question, 1 being very dissatisfied and 4 being very satisfied. Score total range is 8-32. A total score of 32 would be the highest possible Client Satisfaction Score.|One month post treatment - approximately 20 weeks||||units on a scale||Full Range|Mean
2597043|NCT02202499|Primary|Rate of Participant Retention|Practicality: Number of participants completing 3 month post treatment follow-up. Feasibility: Ability to recruit and retain sufficient numbers of the target population, which would be essential in conducting a future randomized clinical trial (RCT).|End of post treatment follow-up period of 3 months - approximately 28 weeks|All participants who completed 3 month post treatment follow up, regardless of study arm|||Participants|||Count of Participants
2597044|NCT02202434|Other Pre-specified|Percentage of Participants With Prosthetic Aortic Valve Endocarditis|Prosthetic aortic valve endocarditis|assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.|Intent to Treat|||Percentage of participants|||Number
2597046|NCT02202434|Other Pre-specified|Percentage of Participants With Prosthetic Aortic Valve Malpositioning|Prosthetic aortic valve malpositioning, including valve migration, valve embolization, or ectopic valve deployment|assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.|Intent to Treat|||Percentage of participants|||Number
2597047|NCT02202434|Other Pre-specified|Percentage of Participants With Cardiac Tamponade|Cardiac tamponade|≤72 hours post index procedure|Intent to Treat|||Percentage of participants|||Number
2597048|NCT02202434|Other Pre-specified|Percentage of Participants With Mitral Apparatus Damage|Mitral apparatus damage|≤72 hours post index procedure|Intent to Treat|||Percentage of participants|||Number
2597049|NCT02202434|Other Pre-specified|Percentage of Participants With Ventricular Septal Perforation|Ventricular septal perforation|≤72 hours post index procedure|Intent to Treat|||Percentage of participant|||Number
2597050|NCT02202434|Other Pre-specified|Percentage of Participants With Coronary Obstruction|Coronary obstruction|≤72 hours post index procedure|Intent to Treat|||Percentage of participants|||Number
2597051|NCT02202434|Other Pre-specified|Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter|New onset of atrial fibrillation or atrial flutter|assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.|Intent to Treat|||Percentage of participants|||Number
2597052|NCT02202434|Other Pre-specified|Percentage of Participants With New Permanent Pacemaker Implantation|New permanent pacemaker implantation resulting from new or worsened conduction disturbances|assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.|Intent to Treat|||Percentage of participants|||Number
2597053|NCT02202434|Other Pre-specified|Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure|Hospitalization for valve-related symptoms or worsening congestive heart failure (New York Hear Association [NYHA] class III or IV)|assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.|Intent to Treat|||Percentage of participants|||Number
2597054|NCT02202434|Other Pre-specified|Percentage of Participants With Repeat Procedure for Valve-related Dysfunction|Repeat procedure for valve-related dysfunction (surgical or interventional therapy)|assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.|Intent to Treat|||Percentage of participants|||Number
2597055|NCT02202434|Other Pre-specified|Percentage of Participants With Major Vascular Complication|Major vascular complication - including access site related and non access site related|assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.|Intent to Treat|||Percentage of participants|||Number
2597056|NCT02202434|Other Pre-specified|Percentage of Participants With Acute Kidney Injury|"Acute kidney injury based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2~Change in serum creatinine (up to 7 days) compared to baseline:~Stage 1: Increase in serum creatinine to 150-199% (1.5-1.99 × increase compared with baseline) OR increase of ≥0.3 mg/dl (≥26.4 mmol/L)~Stage 2: Increase in serum creatinine to 200-299% (2.0-2.99 × increase compared with baseline)~Stage 3: Increase in serum creatinine to ≥300% (>3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L)~-OR-~Based on urine output (up to 7 days):~Stage 1: <0.5 ml/kg per hour for >6 but <12 hours~Stage 2: <0.5 ml/kg per hour for >12 but <24 hours~Stage 3: <0.3 ml/kg per hour for ≥24 hours or anuria for ≥12 hours~Note 1: Subjects receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria."|≤7 days post index procedure|Intent to Treat|||Percentage of participants|||Number
2597057|NCT02202434|Other Pre-specified|Percentage of Participants With Bleeding|"Life-threatening (or disabling) and major (defined below)~Life-threatening or Disabling Bleeding~Fatal bleeding (Bleeding Academic Research Consortium [BARC] type 5124,125)~Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c)~Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b)~Overt source of bleeding with drop in hemoglobin of ≥5 g/dL or whole blood or packed red blood cells (RBC) transfusion ≥4 units (BARC type 3b)~Major Bleeding (BARC type 3a)~Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND does not meet criteria of life-threatening or disabling bleeding"|assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.|Intent to Treat|||Percentage of participants|||Number
2597058|NCT02202434|Other Pre-specified|Percentage of Participants With Myocardial Infarction (MI)|Periprocedural (≤72 hours post index procedure) and spontaneous (>72 hours post index procedure)|assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.|Intent to Treat|||Percentage of participants|||Number
2597059|NCT02202434|Other Pre-specified|Percentage of Participants With Stroke|Disabling Stroke and Non-disabling Stroke|assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.|Intent to Treat|||Percentage of participants|||Number
2597060|NCT02202434|Other Pre-specified|Percentage of Participants With Mortality|All-cause, Cardiovascular, and Non-cardiovascular|assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.|Intent to Treat patients with mortality or who were event free with sufficient follow-up for the applicable time point (30 days - at least 23 days of follow-up; 6 months - at least 150 days of follow-up; 1 year - at least 335 days of follow-up).|||Percentage of participants|||Number
2597142|NCT02201940|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2597061|NCT02202434|Other Pre-specified|Health Status as Evaluated by Quality of Life Questionnaires|"SF-12 and Kansas City Cardiomyopathy - Baseline scores and changes from Baseline at 30 days, 6 months and 1 year~SF-12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.~Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life.~Scores are transformed to a range of 0-100, in which higher scores reflect better health status."|Assessed at Baseline, 1 and 6 months; and 1, 3, and 5 years, at Baseline, 1 and 6 months and 1 Year reported|Intent to Treat|||Score on a scale||Standard Deviation|Mean
2597062|NCT02202434|Other Pre-specified|Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4|"Grade of aortic valve regurgitation: paravalvular, central, and combined. An Independent echocardiographic core lab assessment was performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation for the locations paravalvular, central and combined.~The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome)."|assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.|Intent to Treat|||Percentage of participants|||Number
2597063|NCT02202434|Other Pre-specified|Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3|Assessed by an independent core laboratory - peak aortic velocity|assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.|Intent to Treat|||m/s||Standard Deviation|Mean
2597064|NCT02202434|Other Pre-specified|Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2|Assessed by an independent core laboratory - mean and peak aortic gradients|assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.|Intent to Treat|||mmHg||Standard Deviation|Mean
2597065|NCT02202434|Other Pre-specified|Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1|Assessed by an independent core laboratory, including effective orifice area, mean and peak aortic gradients, and peak aortic velocity|assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.|Intent to Treat|||cm^2||Standard Deviation|Mean
2597066|NCT02202434|Other Pre-specified|Percentage of Participants With Procedural Success|Defined as absence of procedural mortality, correct positioning of a single transcatheter valve into the proper anatomical location , intended performance of the study device (effective orifice area [EOA] >0.9 cm2 for body surface area (BSA) <1.6 m2 and EOA >1.1 cm2 for BSA ≥1.6 m2 plus either a mean aortic valve gradient <20 mm Hg or a peak velocity <3m/sec, and no moderate or severe prosthetic valve aortic regurgitation) plus no serious adverse events|30 days post procedure|Intent to Treat|||Percentage of participants|||Number
2597067|NCT02202434|Other Pre-specified|Percentage of Participants With Clinical Procedural Success|Defined as implantation of the study device in the absence of death, disabling stroke, major vascular complications, and life-threatening or major bleeding|30 days post procedure|Intent to Treat|||Percentage of Participants|||Number
2597068|NCT02202434|Other Pre-specified|Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined|"Grade of aortic valve regurgitation: paravalvular, central, and combined. An Independent echocardiographic core lab assessment was performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation for the locations paravalvular, central and combined.~The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome)."|at discharge or 7 days post-procedure (whichever comes first)|Intent to Treat|||Percentage of Participants|||Number
2597069|NCT02202434|Other Pre-specified|Percentage of Participants With Successful Repositioning of the Study Valve if Repositioning is Attempted|Successful repositioning of the study valve if repositioning is attempted|at discharge or 7 days post-procedure (whichever comes first)|Number of Intent to Treat participants who had Repositioning attempted|||Percentage of Participants|||Number
2597070|NCT02202434|Other Pre-specified|Percentage of Participants With Successful Retrieval of the Study Valve if Retrieval is Attempted|Successful retrieval of the study valve if retrieval is attempted|at discharge or 7 days post-procedure (whichever comes first)|Number of Intent to Treat participants who had Retrieval attempted|||Percentage of Participants|||Number
2597071|NCT02202434|Other Pre-specified|Percentage of Participants With Successful Deployment of the Study Valve|Successful deployment of the study valve|at discharge or 7 days post-procedure (whichever comes first)|Intent to Treat|||Percentage of participants|||Number
2597072|NCT02202434|Secondary|Percentage of Participants With Moderate or Greater Paravalvular Aortic Regurgitation|Moderate or greater paravalvular aortic regurgitation based on Independent echocardiographic core lab assessment performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation by Pibarot et al (J Am Coll Cardiol Img 2015: 8: 340-60). The grading scheme ranges from Trace (the least clinically significant) to severe (the most clinically significant).|1 year following procedure|"ITT - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted.~The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms of the study."|||Percent of Participants|||Number
2597073|NCT02202434|Primary|Percentage of Participants With Events Included in the Primary Effectiveness Endpoint|Composite of all-cause mortality, disabling stroke, or moderate or greater paravalvular aortic regurgitation (based on core lab assessment).|1 year following procedure|"Non-inferiority analysis - Implanted population - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device.~Superiority analysis - Intent to Treat Population The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms."|||Percent of Participants|||Number
2597143|NCT02201940|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
2597074|NCT02202434|Primary|Percentage of Participants With Events Included in the Primary Safety Endpoint|Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications|30 days following procedure|Implanted population - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device. The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms of the study.|||Percent of participants|||Number
2597075|NCT02202317|Secondary|Comparison of Y-90 PET/CT to Y90 SPECT|Number of participants with a similar Y90 distribution depicted on Post Y90 delivery PET/CT and SPECT modalities, specifically comparing Y90 distribution within the treated tumors.|12 Months||||Participants|||Count of Participants
2597076|NCT02202317|Secondary|Comparison Between Treatment Distribution Depicted by Tc99mMAA (Technetium-99m Macroaggregated Albumin) Brehmsstrahlung Scans vs. the Internal Pair Production PET/CT Scans.|Number of participants demonstrating a similar treatment distribution depicted by Tc99mMAA(Technetium-99m macroaggregated albumin) Brehmsstrahlung scans vs. achieved Y-90 distribution on the Internal Pair Production PET/CT scans.|12 months||||Participants|||Count of Participants
2597077|NCT02202317|Primary|Number of Subjects Whose Y-90 Based PET/CT (Positron Emission Tomography/Computed Tomography)Scans Detected Extrahepatic Non-target Embolization.|Number of participants with detected extrahepatic non-target embolization. A qualitative comparison between the two modalities (Y-90 PET/CT and Brehmsstrahlung SPECT) as to the conspicuity of the abnormality would have been conducted had any participant had that result.|12 months||||Participants|||Count of Participants
2597078|NCT02202252|Other Pre-specified|Length of Hospital Stay||Participants will be followed for the duration of hospital stay, an expected average of 5 days||||days||Full Range|Median
2597079|NCT02202252|Secondary|Seroma Formation|Seroma is defined as fluid accumulation below the flaps and will be examined daily after the operation. One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography..|Twenty-four hours after removal of the drains up to 4 weeks||||participants|||Number
2597080|NCT02202252|Primary|Patient Comfort Scale|Patient comfort was measured with a comfort scale between 1-10 measuring incisional pain, pain caused by the drains, discomfort or sleep disturbances caused by the drains. 1 denotes no discomfort related to drains, 10 denotes maximum discomfort unrelieved even with nonsteroid antiinflammatory analgesics. The data will be presented by median value and range (minimum-maximum).|Postoperative 5 days||||units on a scale||Full Range|Median
2597081|NCT02202161|Secondary|Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-AUC(0-10)|The AUC(0-10) following the first dose and prior to the second dose of sitagliptin was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner) on Day 14|PK population.|||Hour×ng/mL||Geometric Coefficient of Variation|Geometric Mean
2597082|NCT02202161|Secondary|Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Tmax Following the First and Second Sitagliptin Doses|The time at which Cmax was observed by determining directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Tmax1 and Tmax2). If data permits, Tmax2 was defined as the time of Cmax following the second dose of sitagliptin.|Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner), 13 and 14 hours (bed time) on Day 14|PK population.|||Hour||Full Range|Median
2597083|NCT02202161|Secondary|Sitagliptin Steady State PK Parameters When Co-dosed With Metformin-Cmax Following the First and Second Sitagliptin Doses|The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data following the first and second dose of sitagliptin on Day 14 (Cmax1 and Cmax2).|Fasting pre-dose (within 15 minutes of dose), 1, 2, 3, 4 (pre-lunch), 10 (pre-dinner), 13 and 14 hours (bed time) on Day 14|PK population.|||Ng/mL||Geometric Coefficient of Variation|Geometric Mean
2597084|NCT02202161|Secondary|Ratio to Baseline in Fasting Apolipoprotein B|Data for fasting apolipoprotein B is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Baseline (pre-dose Day -1) and Day 7, 14|Safety population|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2597085|NCT02202161|Secondary|Ratio to Baseline in Fasting Low-density Cholesterol (LDL) Cholesterol, High-density Cholesterol (HDL) Cholesterol, Total Cholesterol, Non-HDL Cholesterol and Triglycerides|Data for fasting low-density cholesterol (LDL) cholesterol, high-density cholesterol (HDL) cholesterol, total cholesterol, non-HDL cholesterol and triglycerides is presented. Participants withdrawing early were excluded. Results were based on an ANCOVA model: Log(post-Baseline) - Log(Baseline) = Log(Baseline) + treatment + concomitant use of lipid lowering drugs.|Baseline (pre-dose Day -1) and Day 7, 14|Safety population. Only those participants available at the specified time points were analyzed.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2597086|NCT02202161|Secondary|PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-area Under the Concentration-time Curve Over the Dosing Interval of 10 Hours (AUC[0-10])|PK population. Only those participants available at the specified time points were analyzed.|Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14|PK population. Only those participants available at the specified time points were analyzed.|||Hour×ng/mL||Geometric Coefficient of Variation|Geometric Mean
2597087|NCT02202161|Secondary|PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-time of Occurrence of Cmax (Tmax)|The time at which Cmax observed was determined directly from the raw concentration-time data.|Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14|PK population. Only those participants available at the specified time points were analyzed.|||Hour||Full Range|Median
2597098|NCT02202161|Primary|Summary of Urinalysis Data-mean Specific Gravity|Data for mean specific gravity is provided. Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance. Normal urine has a specific gravity between 1.010 and 1.020.|Baseline (pre-dose Day -1), Day 7 and 15|Safety population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2597088|NCT02202161|Secondary|PK Parameters for Metformin Steady State PK Parameters When Co-dosed With GSK2330672, Sitagliptin or Placebo-maximum Observed Concentration (Cmax)|The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data. Statistics for geometric least square mean provided.|Fasting pre-dose (within 15 minutes of dose), 30 minutes, 1, 1.5, 2, 3, 4 (pre-lunch), 5.5, 8, 10 hours (pre-dinner) on Day 14|The PK population was used which was defined as participants from the safety population who had plasma metformin, sitagliptin, and/or GSK2330672 PK parameter estimates from any portion of the study. Only those participants available at the specified time points were analyzed.|||Nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Least Squares Mean
2597089|NCT02202161|Primary|Number of Participants With Fecal Occult Blood Monitoring for Symptomatic or Visible Gastrointestinal Bleeding or Asymptomatic Occult Bleeding|Testing cards were provided to participants for assessments. Participants with abnormal not clinically significant and abnormal clinically significant is presented. The Day -1 sample was obtained any time starting Day -2 and prior to GSK2330672 dosing on Day 1. The Day 14 sample was collected any time after dosing on Day 14 and prior to discharge on Day 15.|Up to Day 15|Safety population|||Participants|||Count of Participants
2597090|NCT02202161|Primary|Number of Participants With Gastrointestinal Tolerability Assessments as Rated Using the Gastrointestinal Symptom Rating Scale (GSRS; With Worsening Symptoms >=2 Levels)|GSRS is a rating scale consisting of 15 items. Each item was scored from 1: no discomfort at all, 2: minor discomfort, 3: mild discomfort, 4: moderate discomfort, 5: moderately severe discomfort, 6: severe discomfort, 7: very severe discomfort. The overall GSRS score is the mean of these 15 items, varying from 1 to 7; a score of 1 indicates that no symptoms are present, and a score of 7 indicates the worst possible degree of all symptoms. A higher score relative to Baseline indicates worsening of severity. There were 5 defined syndrome scores and 1 overall score that was derived by computing the mean of the scores for specific subsets of questions as indicated below: abdominal pain (1, 4, 5); reflux syndrome (2, 3); diarrhea syndrome (11, 12, 14); indigestion syndrome (6, 7, 8, 9); constipation syndrome (10, 13, 15) and overall GSRS (1-15). The data is presented for participants with worsening of symptoms in >=2 levels.|Day 7 and 14|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2597091|NCT02202161|Primary|Number of Events With the Rating on Quality of Stools as Rated Using the BSFS Across Days 1 to 14|The site staff classified participant's stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions.|Up to Day 15 (administered after every in-house bowel movement)|"Safety population. Only those participants available at the specified time points were analyzed. For each BSFS scale rating the Number of Participants Analyzed represents the number of participants reporting that rating not the number evaluated."|||Events|||Number
2597092|NCT02202161|Primary|Number of Bowel Movements (Stool Frequency) as Rated Using the Bristol Stool Form Scale (BSFS) Across Days 1 to 14|The site staff classified participant's stools and record the date and time of occurrence after any bowel movement that occurs while participants were in residence in the clinic. BSFS is scale between type 1-7, it measured the shape of the stool, type 1: separate hard lumps, like nuts; type 2: sausage shaped but lumpy; type 3: like a sausage or snake but with cracks on its surface; type 4: like a sausage or snake, smooth and soft; type 5: soft blobs with clear cut edges; type 6: fluffy pieces with ragged edges, a mushy stool and type 7: watery, no solid pieces. Participants were discharged after they have had at least one bowel movement after the Day 14 dosing and after the investigator/designee had reviewed the Day 15 end of study questions.|Up to Day 15 (administered after every in-house bowel movement)|Safety population|||Count of bowel movements||Standard Deviation|Mean
2597093|NCT02202161|Primary|Change From Baseline in Vital Signs Assessments-heart Rate|The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.|Baseline (pre-dose Day -1) and Day 7, 15|Safety population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2597094|NCT02202161|Primary|Change From Baseline in Vital Signs Assessments-systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.|Baseline (pre-dose Day -1) and Day 7, 15|Safety population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
2597095|NCT02202161|Primary|Change From Baseline in Vital Signs Assessments-temperature|The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value.|Baseline (pre-dose Day -1) and, Day 7, 15|Safety population. Only those participants available at the specified time points were analyzed.|||Degree Celsius||Standard Deviation|Mean
2597096|NCT02202161|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings Any Time Post-Baseline|Single 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Participants with normal, abnormal not clinically significant and abnormal clinically significant ECG is presented.|Up to Day 15|Safety population|||Participants|||Count of Participants
2597097|NCT02202161|Primary|Summary of Urinalysis Data-mean pH|Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Baseline (pre-dose Day -1), Day 7 and 15|Safety population. Only those participants available at the specified time points were analyzed.|||Unit on a scale||Standard Deviation|Mean
2597489|NCT02196831|Secondary|Change in Alanine Aminotransferase (ALT)|change (value at 12 months minus value at baseline)|change from baseline to 12 months|all participants with available data at both baseline and 12 month visits|||units/liter (U/L)||Standard Deviation|Mean
2597099|NCT02202161|Primary|Number of Participants With Abnormal Urinalysis Data|Urinalysis included urine occult blood: trace to 3+, glucose: negative to 3+, protein: negative to 2+ and ketones: trace to negative by dipstick and microscopic examination included cast, cellular cast, granular cast, hyaline cast (none seen to 1) and RBC: 0-2, 3-10, 11-30, >30, WBC: none seen, 0-5, 1, 2, 4, <5, 6-10, 11-30, 19, >30). The plus sign increases with a higher level of occult blood, glucose, ketones, proteins, RBC, WBC in the urine: 1+: slightly positive, 2+: positive, 3+: high positive. Participants were categorized as none seen or 1 based on the absence or presence, respectively, of cast, cellular cast, granular cast and hyaline cast. Higher value indicates higher abnormality.|Baseline (pre-dose Day -1), Day 7 and 15|Safety population.|||Participants|||Count of Participants
2597100|NCT02202161|Primary|Number of Participants With Abnormal Clinical Chemistry With PCI|Clinical chemistry parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, fasting glucose, total carbon dioxide, gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP), total protein, total carbon dioxide and triglycerides. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided. The normal range (NR) and PCI definition for abnormal parameters are: ALT (NR: 0-44, 0-32, 2-33; PCI: >=2×upper limit of normal [ULN]); AST (NR: 0-40; PCI: >=2× ULN) and total bilirubin (NR: 0.00-20.52; PCI: >=1.5× ULN).|Up to Day 15|Safety population.|||Participants|||Count of Participants
2597101|NCT02202161|Primary|Number of Participants With Abnormal Hematology With Potential Clinical Concern (PCI)|Hematology parameters included platelet, red blood cell (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Baseline (pre-dose Day -1), Day 7 and 15. Data for parameters with above and below the PCI is provided.|Up to Day 15|Safety population|||Participants|||Count of Participants
2597102|NCT02202161|Primary|Number of Participants With Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition and alanine aminotransferase (ALT) >= 3× upper limit of normal (ULN) and total bilirubin >=2 × ULN (>35% direct) or ALT >=3 × ULN and international normalized ratio >1.5.|Up to 14 days (treatment period)|Safety population.|||Participants|||Count of Participants
2597103|NCT02202161|Primary|Change From Baseline in Derived Plasma Glucose Parameter Over a 24-hour Period-fasting and Weighted Mean Glucose Area Under Curve (AUC[0-24 Hour])|The change from Baseline was calculated by subtracting the Baseline values from the individual post-Baseline values. Baseline was defined as pre-dose Day -1 value. It was assessed on Baseline, Day 7 and 14. Data for fasting and weighted mean (WM) AUC(0-24 hour) glucose is provided. Statistics for least square mean is provided and participants withdrawing early were excluded. Results were based on an analysis of covariance (ANCOVA) model: change from Baseline = Baseline + treatment.|Baseline (Day -1) and Day 14 (Fasting Pre-dose [within 15 minutes of dose], 30 minutes, 1, 1.5, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, 14 [bed time] and 24 hours) and Day 7 (30 minutes, 2, 4 [pre-lunch], 5.5, 10 [pre-dinner], 11.5, and 24 hours)|Safety population was used which was defined as all participants enrolled into the study who received at least one dose of study drug (including GSK2330672, GSK2330672-matched placebo, sitagliptin and metformin). Only those participants available at the specified time points were analyzed.|||Mg/deciliter||Standard Deviation|Mean
2597104|NCT02202135|Primary|Clinical Response at TOC|Clinical cure is defined as resolution or improvement of signs and symptoms compared to baseline and no further antimicrobial therapy is necessary. Clinical failure is defined as any of the following: persistence or worsening in signs or symptoms, or requirement for concomitant antibiotic therapy, or requirement of an unplanned surgical intervention >48 hours after the first dose, or death caused by skin infection, or an AE leading to study drug discontinuation with alternative antimicrobial therapy required, or diagnosis of osteomyelitis >=8 days after the first dose.|7 to 20 days after last dose of study drug|Randomized|||Participant|||Number
2597105|NCT02202109|Secondary|Proportion of Participants With a Change in Access to Care|Access to care was defined as having a routine source of care and measured at both pre(baseline) and post (exit).|Baseline, 6 months|Only participants with complete information on access to care were included in the analysis.|||proportion of participants||95% Confidence Interval|Number
2597106|NCT02202109|Secondary|Proportion of Change in Cervical Cancer Knowledge Among Participants|Cervical cancer knowledge was measured with a series of questions asked at both pre(baseline) and post (exit). The questions were designed to measure participant's knowledge of cervical cancer prior to the study intervention and following the intervention. Cervical cancer knowledge is defined by participants answering 3 out 5 questions correctly.|Baseline, 6 months||||proportion of participants||95% Confidence Interval|Number
2597107|NCT02202109|Primary|Number of Participants Completing a Self-sampling Test|The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days.|2 to 6 months|Participants were given up to 6 months to complete HPV self-sampling.|||Participants|||Count of Participants
2597108|NCT02202044|Other Pre-specified|To Assess Long-term Morbidity in the Study Group, as Defined by Requirement for Fewer TURBTs, Courses of Traditional Intravesical Therapies, and Surveillance Cystoscopies Over 5 Years (Cost-effectiveness)||5 years|||||||
2597109|NCT02202044|Other Pre-specified|To Compare the Qualitative and Quantitative Toxicities of Experimental Regimens in These Patients.||5 years|||||||
2597514|NCT02196714|Secondary|Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar volume)|12 Hours|Safety Population|||fL||Standard Deviation|Mean
2597112|NCT02202031|Secondary|Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Maze Task at 12 Weeks|The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed|Baseline to 12 weeks|Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.|||msec||95% Confidence Interval|Least Squares Mean
2597113|NCT02202031|Secondary|Change From Baseline in Pre-ejection Period (PEP) Change From Rest to Dot Task at 12 Weeks.|The time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed|Baseline to 12 weeks|Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.|||msec||95% Confidence Interval|Least Squares Mean
2597114|NCT02202031|Secondary|Change From Baseline in Pre-ejection Period (PEP) Resting (Neutral) State at 12 Weeks.|PEP is the time period during which the left ventricle of the heart contracts while the aortic and mitral valves are still closed, is an established measure of sympathetic autonomic activity that can be measured non-invasively using impedance cardiography .|Baseline to 12 weeks|Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.|||msec||95% Confidence Interval|Least Squares Mean
2597115|NCT02202031|Secondary|Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Maze Task at 12 Weeks|high frequency heart rate variability|Baseline to 12 weeks|Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.|||msec^2||95% Confidence Interval|Least Squares Mean
2597116|NCT02202031|Secondary|Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Change From Rest to Dot Task at 12 Weeks.|High frequency heart rate variability|Baseline to 12 weeks|Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.|||msec2||95% Confidence Interval|Least Squares Mean
2597117|NCT02202031|Secondary|Change From Baseline in Respiratory Sinus Arrhythmia (RSA) Resting (Neutral) State at 12 Weeks.|Change in autonomic control as assessed by high frequency heart rate variability (RSA)|Baseline to 12 weeks|Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.|||msec^2||95% Confidence Interval|Least Squares Mean
2597118|NCT02202031|Secondary|Change From Baseline in Respiratory Sinus Arrhythmia at 12 Weeks.|Resting (neutral) state|Baseline to 12 weeks|Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint. This measure was only completed by a small subset of participants.|||msec^2||95% Confidence Interval|Least Squares Mean
2597119|NCT02202031|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Overall Sleep Quality Score at 12 Weeks.|An 18-item validated questionnaire evaluating sleep quality, sleep latency, sleep efficiency, and sleep problems over a one-week period. A global sleep quality score ranging from 0 to 21 can be derived from the PSQI, with higher scores reflecting poor sleep quality.|Baseline to 12 weeks|Although 77 participants randomized to Music Therapy and 74 participant randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.|||score on a scale||95% Confidence Interval|Least Squares Mean
2597120|NCT02202031|Secondary|Change From Baseline in Perceived Stress Scale (PSS) Score at 12 Weeks.|A 10-item self-administered questionnaire assessing subjective feelings and thoughts related to perceived stress in the past month, validated in a probability sample of the United States. Scores range from 0 to 40, with higher scores indicating greater perceived stress.|Baseline to 12 weeks|Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.|||score on a scale||95% Confidence Interval|Least Squares Mean
2597121|NCT02202031|Secondary|Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Score at 12 Weeks.|A 20-item measure that has been widely used in clinical trials, including trials of bladder interventions, and is sensitive to change. Total scores range from 0 to 60, with higher scores indicating greater likelihood of depression.|Baseline to 12 weeks|Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.|||score on a scale||95% Confidence Interval|Least Squares Mean
2597122|NCT02202031|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score at 12 Weeks.|A validated self-administered questionnaire that includes a 7-item Anxiety Subscale shown to be sensitive to change in incontinence trials. Scores range from 0 to 21, with higher scores indicating greater anxiety.|Baseline to 12 Weeks|Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.|||score on a scale||95% Confidence Interval|Least Squares Mean
2597123|NCT02202031|Secondary|Change From Baseline on Spielberger State Trait Anxiety Inventory (STAI) - Trait Component Score at 12 Weeks.|A 20-item self-administered measure validated in both clinical and psychiatric populations, including patients with bladder symptoms. Scores range from 20 to 80, with higher scores indicating greater somatic anxiety.|Baseline to 12 Weeks|Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.|||score on a scale||95% Confidence Interval|Least Squares Mean
2597124|NCT02202031|Secondary|Change From Baseline on Patient Perception of Bladder Condition (PPBC) Score at 12 Weeks.|A single-item assessing patient's overall perception of their bladder problems using a 6-point Likert scale, score range 1-6. The higher the score the more severe.|Baseline to 12 weeks|Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.|||score on a scale||95% Confidence Interval|Least Squares Mean
2597125|NCT02202031|Secondary|Change From Baseline in Urogenital Distress Inventory Short Form (UDI-6) Score at 12 Weeks.|A 6-item measure of the bothersomeness of multiple urinary symptoms, including urgency and incontinence; scores range from 0-100. Higher the score, the more distress.|Baseline to 12 weeks|Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.|||score on a scale||95% Confidence Interval|Least Squares Mean
2597126|NCT02202031|Secondary|Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Health-Related Quality of Life Subscale at 12 Weeks.|A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more interference with quality of life.|Baseline to 12 weeks|Although 77 participants randomized to Music Therapy and 74 participants randomized to Paced Respiration completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.|||score on a scale||95% Confidence Interval|Least Squares Mean
2597127|NCT02202031|Secondary|Change From Baseline Score of Urgency Severity and Impact Questionnaire (USIQ), Severity Subscale at 12 Weeks.|A 13-item measure of the severity and impact of urgency validated specifically in patients with OAB, range of 0-100. Higher the severity score, the more severe.|Baseline to 12 weeks.|Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.|||score on a scale||95% Confidence Interval|Least Squares Mean
2597128|NCT02202031|Secondary|Change From Baseline in Overactive Bladder Questionnaire Score at 12 Weeks|A 33-item measure of the bothersomness and impact of multiple OAB symptoms (such as urgency, incontinence, nocturia) along a 100-point scale. Higher the score the greater the bothersome.|Baseline to 12 weeks.|Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.|||score on a scale||95% Confidence Interval|Least Squares Mean
2597129|NCT02202031|Secondary|Change From Baseline in Total Voiding Episodes at 12 Weeks.|Self-reported on voiding diary.|Baseline to 12 weeks|Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.|||episodes||95% Confidence Interval|Least Squares Mean
2597130|NCT02202031|Secondary|Change From Baseline in Urgency Incontinence Episodes at 12 Weeks.|Self-reported on voiding diary|Baseline to 12 weeks.|Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.|||episodes||95% Confidence Interval|Least Squares Mean
2597131|NCT02202031|Secondary|Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With a Severe Sensation of Urgency at 12 Weeks.|Self-reported on voiding diary|Baseline to 12 weeks|Although 77 participants randomized to Music Therapy completed week 12 visits in some form, some participants declined to complete or had missing data for one or more outcome measures at this timepoint.|||episodes||95% Confidence Interval|Least Squares Mean
2597132|NCT02202031|Primary|Change From Baseline in Frequency of Any Voiding or Incontinence Episodes Associated With At Least a Moderate Sensation of Urgency at 12 Weeks.|Self-reported on voiding diary.|Baseline to 12 weeks||||episodes||95% Confidence Interval|Least Squares Mean
2597133|NCT02201953|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2597134|NCT02201953|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24||Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2597135|NCT02201953|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24||Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2597136|NCT02201953|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2597137|NCT02201953|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set|||percentage of participants|||Number
2597138|NCT02201953|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2597139|NCT02201940|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2597144|NCT02201940|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants randomized or enrolled into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2597145|NCT02201901|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score|CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15; higher scores/increased scores indicate greater severity of disease.|Baseline to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2597146|NCT02201901|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score|Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.|Baseline to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2597147|NCT02201901|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,~> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment,~HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)~Relapse~HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2597148|NCT02201901|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24||Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2597149|NCT02201901|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24||Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2597150|NCT02201901|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2597151|NCT02201901|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks plus 30 days|Safety Analysis Set|||percentage of participants|||Number
2597152|NCT02201901|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.|Posttreatment Week 12|The Full Analysis Set (FAS): participants who were randomized into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2597153|NCT02201784|Other Pre-specified|Pulse Rate, Mean Arterial Pressure, SpO2|Intragroup and intergroup variation compared|8 hours|||||||
2597154|NCT02201784|Secondary|Duration of Motor Block|Time when the Bromage score will be back to zero|8 hours||||minutes||Standard Deviation|Mean
2597155|NCT02201784|Secondary|Onset of Motor Block to Bromage3|Motor block in the lower limbs was graded according to the modified Bromage scale (Grade 0 = No motor block, Grade 1 = Inability to raise extended leg, able to move knees and feet, Grade 2 = Inability to raise extended leg and move knee, able to move feet, Grade 3 = Complete motor block of the lower limbs). Thereafter, It was performed every 5 minutes till the attainment of MB grade 3 followed by every 30 minutes until complete recovery (MB grade0).|8 hours||||minutes||Standard Deviation|Mean
2597156|NCT02201784|Secondary|Time to Maximum Cephalic Spread of Sensory Block||8 hours||||minutes||Standard Deviation|Mean
2597157|NCT02201784|Secondary|Median Maximum Level of Sensory Blockade|level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.|8 hours|||||||
2597158|NCT02201784|Secondary|Onset of Sensory Block at T10|level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.|30 minutes||||minutes||Standard Deviation|Mean
2597159|NCT02201784|Primary|Duration of Analgesia|Defined as time for first analgesic request by the patient|8 hours||||minutes||Standard Deviation|Mean
2597160|NCT02201771|Other Pre-specified|The Rate of Gastroduodenal Injury Assessed by Esophagogastroduodenoscopy (EGD)|Not all but the patients recruited in Ruijin Hospital|at 12 months|||||||
2597161|NCT02201771|Secondary|Number of the Major Bleeding Events|"According to modified TIMI criteria, the Major Bleeding Events is defined as the combination of CABG-related bleeding and non-CABG-related major bleeding(Intracranial bleeding, Clinically overt signs of hemorrhage with hemoglobin drop ≥5 g/dL and Fatal bleeding)."|up to 12 months||||events|||Number
2597162|NCT02201771|Secondary|The Number of Major Adverse Cardiovascular Event (MACE)|MACE, composite of CV death, myocardial infarction or stroke (ischaemic or unknown etiology)|up to 12 months||||events|||Number
2597163|NCT02201771|Secondary|The Rate of Freedom From Angina According to Canadian Cardiovascular Society (CCS) Classification|Number of Participants Free of Angina per CCS Classification|up to 12 months||||Participants|||Count of Participants
2597164|NCT02201771|Secondary|The Rate of Post-operative Atrial Fibrillation After CABG.|Number of Participants with Post-operative Atrial Fibrillation after CABG|up to 7 days||||Participants|||Count of Participants
2597165|NCT02201771|Secondary|The Patency of Saphenous Vein Grafts|"assessed by MSCTA or CAG. FitzGibbon grade A (stenosis <50%) is defined as patency."|up to 7 days||||percentage of patent SV grafts|saphenous vein grafts|95% Confidence Interval|Number
2597526|NCT02196714|Primary|Tmax|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (tmax)|Day 1|Pharmacokinetic Population|||h||Full Range|Mean
2597166|NCT02201771|Primary|The Patency of Saphenous Vein Grafts|"assessed by multislice computed tomography angiography (MSCTA) or coronary angiography(CAG). FitzGibbon grade A (stenosis <50%) is defined as patency."|up to 12 months|ITT analysis, Patients with missing data were considered to have occluded saphenous vein grafts.|||percentage of patent SV grafts|saphenous vein grafts|95% Confidence Interval|Number
2597167|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters|ECG change data was reported as qualitative results, as per change in planned analysis. It was categorized as: normal; abnormal, not clinically significant or abnormal, clinically significant.|Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2597168|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Heart Rate||Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.|||bpm|||Number
2597169|NCT02201524|Secondary|Change From Baseline in Body Temperature at Week 1, 2, 3, 4, 5, 6, and 8||Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||degree celsius||Standard Deviation|Mean
2597170|NCT02201524|Secondary|Change From Baseline in Respiratory Rate at Week 1, 2, 3, 4, 5, 6, and 8||Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||respiration per minute (resp/min)||Standard Deviation|Mean
2597171|NCT02201524|Secondary|Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, 5, 6, and 8||Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||beats per minute (bpm)||Standard Deviation|Mean
2597172|NCT02201524|Secondary|Change From Baseline in Blood Pressure (BP) at Week 1, 2, 3, 4, 5, 6, and 8||Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2597173|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Herpes Simplex Virus Deoxyribonucleic Acid (HSV DNA) Values|HSV DNA samples were collected and changes from baseline were evaluated by the PI for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in AEs or required follow-up.|Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2597174|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Cytomegalovirus (CMV) Values|CMV samples were collected and changes from baseline were evaluated by the PI for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in AEs or required follow-up.|Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2597175|NCT02201524|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Epstein-Barr Virus (EBV) Values|EBV samples were collected and changes from baseline were evaluated by the principal investigator (PI) for clinical significance. Clinical significance is levels outside of the normal range (abnormal levels) with clinically apparent viral disease, or that resulted in adverse event (AEs) or required follow-up.|Baseline up to Week 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2597176|NCT02201524|Secondary|Change From Baseline in High Sensitivity C- Reactive Protein (hsCRP) at Week 1, 2, 3, 4, and 8|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Reference range for measurements is 0-0.5 mg/dL and lower limit of detection is less than (<) 0.015 mg/dL. Any value <0.015 mg/dL is imputed as 0.0075 mg/dL.|Baseline, Week 1, 2, 3, 4, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2597177|NCT02201524|Secondary|Change From Baseline in Lipid Ratios at Week 2, 4 and 8|The ratio of LDL-C/HDL-C was reported.|Baseline, Week 2, 4, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||ratio||Standard Deviation|Mean
2597178|NCT02201524|Secondary|Change From Baseline in Fasting Lipids at Week 2, 4 and 8|Participants were required to fast 9 hours prior to sampling for lipid profile which included following parameters: low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), cholesterol, triglycerides.|Baseline, Week 2, 4, 8 (early termination)|The safety analysis population set included all enrolled participants who received at least 1 dose of study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2597203|NCT02201329|Secondary|Maximum Measured Concentration of the Volasertib 200 mg in Plasma (Cmax)|This outcome measure presents maximum measured concentration of Volasertib 200 mg in plasma (Cmax).|-0.05 hours before drug administration and 0:30 (hours:minutes), 1:00, 1:30, 2:00, 3:00, 4:00, 24:30, 48:30, 96:30, 144:30 and 335:55 after drug administration.|Treated Set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of either Volasertib or Azacitidine.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2597515|NCT02196714|Secondary|Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 Hours|Safety Population|||g/L||Standard Deviation|Mean
2597179|NCT02201524|Secondary|Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' at Week 1, 2, 3, 4, 5, 6, and 8|The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema (E), induration (I), and scaling (S) across all psoriatic lesions. The severity rating scores (erythema: 0= no evidence of erythema to 4= dark, deep red; Induration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders; Scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S= total) and the average (total/3) was taken. The total average was rounded to the nearest whole number score to determine the PGA. The 5-point scale for PGA was: 0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe, where higher score indicating more severity. Participants with response of clear and almost clear were reported. 90 percent confidence intervals were calculated using clopper-pearson (exact) method.|Week 1, 2, 3, 4, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants||90% Confidence Interval|Number
2597180|NCT02201524|Secondary|Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8|PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 90 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method.|Baseline, Week 1, 2, 3, 4, 5, 6, 8 (early termination)|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants||90% Confidence Interval|Number
2597181|NCT02201524|Secondary|Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6 and 8|PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 75 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method.|Baseline, Week 1, 2, 3, 4, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants||90% Confidence Interval|Number
2597182|NCT02201524|Secondary|Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score at Week 1, 2, 3, 4, 5, 6, and 8|PASI score is combined assessment of lesion severity and area affected into single score range:0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated:0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4). Participants who had at least 50 percent reduction in PASI score relative to baseline PASI Score are reported. 90 percent confidence intervals are calculated using clopper-pearson (exact) method.|Baseline, Week 1, 2, 3, 4, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants||90% Confidence Interval|Number
2597183|NCT02201524|Secondary|Change From Baseline in PASI Score at Week 1, 2, 3, 5, 6 and 8|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).|Baseline, Week 1, 2, 3, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2597204|NCT02201329|Secondary|Overall Objective Response (OR): Complete Remission (CR), Partial Remission (PR), or Marrow CR (mCR)|This outcome measure presents overall Objective Response (CR+PR+mCR). Response to treatment was evaluated according to the International Working Group (IWG) 2006 criteria. Best response was tabulated from all available data, with each patient being classified into one of the categories defined in CR, PR, mCR.|Up to 9 months.|Treated Set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of either Volasertib or Azacitidine.|||Participants|||Number
2597184|NCT02201524|Secondary|Percent Change From Baseline in PASI Score at Week 1, 2, 3, 4, 5, 6, and 8|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).|Baseline, Week 1, 2, 3, 4, 5, 6, 8|The mITT analysis set included all randomized participants who received at least 1 dose of the randomized study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
2597185|NCT02201524|Primary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 4|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4).|Baseline, Week 4|The modified intent to treat (mITT) analysis set included all randomized participants who received at least 1 dose of the randomized study drug (PF-04965842 or placebo). Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2597186|NCT02201446|Secondary|MIF||Day 3|Only 62 ARDS patients with Day 3 blood samples were analyzed|||ng/ml||Standard Deviation|Mean
2597187|NCT02201446|Secondary|IL-6||Day 3|Only 62 ARDS patients with Day 3 blood samples were analyzed|||pg/ml||Standard Deviation|Mean
2597188|NCT02201446|Secondary|TNF-α||Day 3|Only 62 ARDS patients with Day 3 blood samples were analyzed|||pg/ml||Standard Deviation|Mean
2597189|NCT02201446|Secondary|Death||up to 28 days||||participants|||Number
2597190|NCT02201446|Secondary|Days of Unassisted Ventilation||1 year||||days||Inter-Quartile Range|Mean
2597191|NCT02201446|Secondary|Length of Hospital Stay||1 year||||days||Inter-Quartile Range|Mean
2597192|NCT02201446|Secondary|Length of Stay in the ICU||1 year|not collected for healthy volunteers|||days||Inter-Quartile Range|Mean
2597193|NCT02201446|Primary|Serum Soluble Cluster of Differentiations 74 (sCD74)|The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein.|Day 3|Only 62 ARDS patients with Day 3 blood samples were analyzed.|||ng/ml||Standard Deviation|Mean
2597194|NCT02201446|Primary|Serum Soluble Cluster of Differentiations 74 (sCD74)|The concentration of sCD74 was determined using Elx800 (BioTek Instruments, Inc. VT), and normalization was based on concentration-response curves, using CD74 recombinant protein.|Day 1||||ng/ml||Standard Deviation|Mean
2597195|NCT02201446|Primary|Acute Physiology and Chronic Health Evaluation (APACHE) II Scores|APACHE II scores range from 0 to 71. A higher values represent a worse outcome.|up to 28 days|not collected for healthy volunteers|||Scores on a scale||Standard Deviation|Mean
2597196|NCT02201446|Primary|Fraction of Inspired Oxygen (FiO2)/Partial Arterial Oxygen Pressure (PO2)||up to 28 days|not collected for healthy volunteers|||ratio||Standard Deviation|Mean
2597197|NCT02201446|Primary|Number of Participants Receiving Mechanical Ventilation||up to 28 days|not collected for healthy volunteers|||participants|||Number
2597198|NCT02201420|Secondary|Time to Localization|Number of Participants with Localization at One Hour|1 hour||||participants localizing in 1 hour|||Number
2597199|NCT02201420|Primary|Localization|Count of subjects with a localization by Tc 99m tilmanocept by imaging. Localization is based on the use of SPECT imaging and defined as the accumulation of radioactivity at intensity greater than background.|Up to 4 days||||participants|||Number
2597200|NCT02201394|Primary|Platelet Aggregation Using Multiplate Analyzer|Platelet function normalization using different concentrations of fresh platelet within 48 hours of Ticagrelor Loading dose/last Maintenance dose, assessed using Multiplate Aggregometry (ADPtest), results expressed as Area Under Curve (U), where 1 U = 10 AU * min.|Baseline (pre-treatment), 4, 6, 24, and 48 hours post Loading dose/last Maintenance dose|Patients with stable CVD|||10 AU * min||Standard Deviation|Mean
2597201|NCT02201394|Primary|P2Y12 Reaction Unit (PRU)|Platelet function normalization using different concentrations (0%, 25%, 50%, and 75% supplementations) of fresh platelet within 48 hours of Ticagrelor Loading dose/last Maintenance dose, assessed using VerifyNow and expressed as P2Y12 Reaction Unit (PRU). The P2Y12 reaction unit (PRU) is an arbitrary unit of measure that represents the amount of platelet aggregation specific to the P2Y12 receptor.|Baseline (pre-treatment), 4, 6, 24 and 48 hours post Loading dose/last Maintenance dose|Patients with stable CVD|||PRU||Standard Deviation|Mean
2597202|NCT02201329|Secondary|Area Under the Concentration-Time Curve of Volasertib 200 mg in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)|This outcome measure presents area under the concentration-time curve of Volasertib 200 mg + Azacitidine 75 mg/m^2 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).|-0.05 hours before drug administration and 0:30 (hours:minutes), 1:00, 1:30, 2:00, 3:00, 4:00, 24:30, 48:30, 96:30, 144:30 and 335:55 after drug administration.|Treated Set (TS): This patient set included all patients who were dispensed study medication and were documented to have taken at least one dose of either Volasertib or Azacitidine.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2597205|NCT02201329|Primary|Maximum Tolerated Dose of Volasertib|This outcome measure presents MTD of Volasertib in Combination with Azacitidine. The MTD was defined as the highest dose level at which Dose Limiting Toxicities (DLTs) were reported in not more than 1 in 6 evaluable patients during Cycle 1.|Up to 57 days.|MTD Set: This patient set included all patients in the treated set who were evaluable for MTD determination.|||mg|||Number
2597206|NCT02201329|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)|"This outcome measure presents number of participants with DLTs in the first cycle for the determination of MTD. DLT was defined as any of the following Adverse Events (AEs) considered to be related to the study drug (Volasertib and/or Azacitidine).~Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 drug-related non-haematologic toxicity.~Drug-related AEs that led to inability to deliver the full dose of the study drugs (Volasertib and/or Azacitidine) according to the assigned dose level within Cycle 1.~Absence of haematological recovery (sustained CTCAE grade ≥3 thrombocytopenia <50000/mm^3 and/or neutropenia <1000/mm^3) after completing Cycle 1 and lasting at least until Day 57 (from Day 1 of Cycle 1) despite complete marrow blast clearance on Day 29 (<5% blasts in the bone marrow.~Any other drug-related AEs that required treatment delay of ≥4 weeks between the Cycle 1 and Cycle 2 (i.e., Cycle 2 was not started until Day 57 of Cycle 1))."|Up to 57 days.|MTD Set: This patient set included all patients in the treated set who were evaluable for MTD determination.|||Participants|||Number
2597207|NCT02201290|Primary|Number of Participants With Adverse Events|"Frequency of all adverse events (including Ophthalmic events) categorized using CTCAE toxicity grades and clinical laboratory test [ Time Frame: Up to Week 4 Follow-up period ] Clinical laboratory assessments and frequency of all adverse events, categorized using Common Terminology Criteria for Adverse Events (CTCAE) toxicity grades will present safety and tolerability endpoints~Serious Adverse Events are below. See All Adverse Events in the following section for specifics~No statistical analysis was planned for this primary outcome"|Up to week 4 follow up period|All treated subjects|||participants|||Number
2597208|NCT02201277|Secondary|IVC Filter Improved Patient Follow Up and Prompt Filter Removal: Number of Days|The research also aims to improve the standard of care for IVC filter patient follow up as the FDA and Society of Interventional Radiology (SIR) recommend that IVC filters be removed as soon as it is safe to do so. Ideally filters will be imaged and removed after 30 days but in some cases patients will need filters to remain in place longer. We will make every effort to encourage patients and their medical team to return for follow up imaging and filter removal as soon as is deemed medically safe.|Number of participants who had filters removed after 30 days up to 1 year|Participants|||Days|Filter||Number
2597209|NCT02201277|Secondary|IVC Filter Improved Patient Follow Up and Prompt Filter Removal|The research also aims to improve the standard of care for IVC filter patient follow up as the FDA and Society of Interventional Radiology (SIR) recommend that IVC filters be removed as soon as it is safe to do so. Ideally filters will be imaged and removed after 30 days but in some cases patients will need filters to remain in place longer. We will make every effort to encourage patients and their medical team to return for follow up imaging and filter removal as soon as is deemed medically safe.|Number of participants who had filters removed after 30 days up to 1 year||||Filter|Filter||Number
2597210|NCT02201277|Secondary|IVC Filter Clot|Thrombus (or clot) formed in the IVC filter 30 days after placement will be assessed radiographically.|30 days|the population sample size was not large enough to see differences between groups.|||Participants|||Count of Participants
2597211|NCT02201277|Secondary|IVC Filter Fracture|Fracture of the component legs and struts of the IVC filter will be determined radiographically 30 days after placement.|30 days||||Participants|||Count of Participants
2597212|NCT02201277|Secondary|IVC Filter Tilt|number of participants with tilt of greater than 15 degrees in any CT imaging studies after filter placement and before removal of filter or study endpoint reached.|0-365 days post placement until project closure or patient endpoint reached||||participants|||Number
2597213|NCT02201277|Secondary|Number of Participants With IVC Filter Migration|The number of participants with IVC filter migration in terms of distance migrated from initial placement location 30 days after filter placement will be assessed radiographically.|30 days||||Participants|||Count of Participants
2597214|NCT02201277|Secondary|Computerized Tomography (CT) Studies With IVC Penetration|All CT studies with IVC penetration ≥ 3 mm, (%)|0-1733 days|Imaging was analyzed to see if filter penetration could be observed and there was some penetration on imaging but nothing beyond 3mm.|||Penetrating filter struts|||Number
2597215|NCT02201277|Primary|IVC: Filter Penetration|Using imaging analysis, patients will resume their standard care as normal but be encouraged to come back in 30 days for imaging followup and removal. other than that we will look at all available CT and xray imaging that clearly shows the filter and IVC vessel walls. We will count how many participants have penetration of the IVC greater than 3mm and the number of days since placement at imaging timepoints. The number of struts or hooks per filter with penetration will also be recorded.|in dwelling time in 1 day after filter insertion up to 3 years.|patients consented to the trial and needing a temporary ivc filter|||Participants|||Number
2597216|NCT02201056|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity of TAK-935||Multiple time-points (Up to 96 hours) post-dose|PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.|||ng*hr/mL||Standard Deviation|Mean
2597217|NCT02201056|Secondary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935||Multiple time-points (Up to 96 hours) post-dose|PK set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.|||ng*hr/mL||Standard Deviation|Mean
2597218|NCT02201056|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-935||Multiple time-points (Up to 96 hours) post-dose|Pharmacokinetic (PK) set included all participants in the safety set who had at least 1 measurable plasma or urine concentration.|||ng/mL||Standard Deviation|Mean
2597219|NCT02201056|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Electrocardiogram (ECG) Measurements at Least Once Post-dose|The percentage of participants with any markedly abnormal criteria for standard 12-lead ECG measured collected during the treatment period.|Day 1 to Day 14|Safety set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
2597220|NCT02201056|Primary|Percentage of Participants Who Meet Markedly Abnormal Criteria, for Vital Sign Measurements at Least Once Post-dose|The percentage of participants with any markedly abnormal vital signs (oral temperature, respiration rate, pulse, and blood pressure) collected during the treatment period.|Day 1 to Day 14|Safety set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
2597221|NCT02201056|Primary|Percentage of Participants Who Meet the Markedly Abnormal Criteria, for Safety Laboratory Tests at Least Once Post-dose|The percentage of participants with any markedly abnormal standard safety laboratory values (hematology, serum chemistries, and urinalysis) collected during the treatment period.|Day 1 to Day 14|Safety set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
2597222|NCT02201056|Primary|Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)|An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after the last dose of study drug.|Day 1 to Day 30|Safety set included all participants who were enrolled and received study drug.|||percentage of participants|||Number
2597223|NCT02200770|Secondary|Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (RCP+OLP)|Number of participants with positive ADA titer to inebilizumab in RCP and OLP (combined) is reported.|RCP: Pre and post dose on Day 1; and on Days 29, 85, and 197; OLP: Pre and post dose on Day 1; and on Days 92, 183, 274, and then every 6 months until maximum of 3 years|Any inebilizumab population included all participants who received at least one dose of inebilizumab either in the RCP or OLP.|||Participants|||Count of Participants
2597224|NCT02200770|Secondary|Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Inebilizumab (During RCP)|Number of participants with positive ADA titer to inebilizumab during RCP is reported.|Pre and post dose on Day 1; and on Days 29, 85, and 197|The ITT population included all participants who were randomized and grouped according to their randomized treatment.|||Participants|||Count of Participants
2597225|NCT02200770|Secondary|Area Under the Serum Concentration Time Curve of the Dosing Interval (AUC0-14d) of Inebilizumab (During RCP)|Area under the serum concentration time curve of the dosing interval (AUC0-14d) of inebilizumab during RCP is reported.|Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197)|"The ITT population included all participants who were randomized and grouped according to their randomized treatment. Out of overall number of participants analyzed”, only participants who had adequate pharmacokinetic sample of inebilizumab per specified dose levels (Dose 1 and Dose 2) were analyzed."|||μg*d/mL||Geometric Coefficient of Variation|Geometric Mean
2597226|NCT02200770|Secondary|Maximum Observed Serum Concentration (Cmax) of Inebilizumab (During RCP)|Maximum observed serum concentration of inebilizumab during RCP is reported.|Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197)|"The ITT population included all participants who were randomized and grouped according to their randomized treatment. Out of overall number of participants analyzed”, only participants who had adequate pharmacokinetic sample of inebilizumab per specified dose levels (Dose 1 and Dose 2) were analyzed."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2597227|NCT02200770|Secondary|Time to Maximum Serum Concentration (Tmax) of Inebilizumab (During RCP)|Time to maximum serum concentration of inebilizumab during RCP is reported.|Dose 1 (Pre and post dose on Day 1 and Day 8); and Dose 2 (pre and post dose on Day 15; and Days 29, 57, 85, 113, 155, and 197)|"The ITT population included all participants who were randomized and grouped according to their randomized treatment. Out of overall number of participants analyzed”, only participants who had adequate pharmacokinetic sample of inebilizumab per specified dose levels (Dose 1 and Dose 2) were analyzed."|||Days||Full Range|Median
2597228|NCT02200770|Secondary|Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During OLP|Number of participants with at least a 2-grade shift from baseline to worst toxicity grade in hematology and chemistry during OLP is reported.|Day 198 through end of OLP (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years)|Open-label population included all participants who received at least one dose of study drug during OLP. Here, number analyzed “n” signifies participants who were analyzed for the specified parameter.|||Participants|||Count of Participants
2597229|NCT02200770|Secondary|Number of Participants With at Least a 2-Grade Shift From Baseline to Worst Toxicity Grade in Hematology and Chemistry During RCP|Number of participants with at least a 2-grade shift from baseline to worst toxicity grade in hematology and chemistry during RCP is reported.|Day 1 (Baseline) through Day 197|As-treated population included all participants who received any dose of study drug and analyzed according to the treatment received. Here, number analyzed “n” signifies participants who were analyzed for the specified parameter.|||Participants|||Count of Participants
2597230|NCT02200770|Secondary|Number of Participants With TEAEs and TESAEs During OLP|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the OLP.|Day 198 through end of OLP period (maximum of 3 years after the last participant enters, until regulatory approval or study discontinuation, whichever occurs first) (approximately 3 years)|Open-label population included all participants who received at least one dose of study drug during OLP.|||Participants|||Count of Participants
2597242|NCT02200614|Primary|Metastasis-Free Survival|Metastasis-Free Survival (MFS) is defined as the time from randomisation to evidence of metastasis or death from any cause, whichever occurs first|From randomization to the time approximately 385 MFS events were observed (approximately 48 months)||||months||95% Confidence Interval|Median
2597427|NCT02197377|Secondary|Oropharyngeal Leak Pressure|The aim of this study is to compare on the oropharyngeal leak pressure in LMA Unique™ and LMA Supreme™ applications|before surgery|Non parametric data between groups were analyzed with the X2-test, while parametric data were compared with unpaired t-test. P < 0.05 was considered significant.|||cm H20||Standard Deviation|Mean
2597231|NCT02200770|Secondary|Number of Participants With Treatment Emergent Adverse Events TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) During RCP|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug during the RCP.|Day 1 (Baseline) through Day 197|As-treated population included all participants who received any dose of study drug and analyzed according to the treatment received.|||Participants|||Count of Participants
2597232|NCT02200770|Secondary|Annualized AC-determined NMOSD Attack Rate During Any Exposure to Inebilizumab|Annualized attack rate is defined as total number of AC-determined attacks divided by total person years. Total person-years is calculated as the sum of the person-years for individual participant. Person-year for individual participant = (Date of last day before safety follow-up period - first inebilizumab dose date +1)/365.25. Annualized AC-determined NMOSD attack rate during any exposure to inebilizumab (in RCP and OLP) is reported.|For participants randomized to inebilizumab: Day 1 of RCP through end of OLP (approximately 3.5 years); and for participants randomized to placebo: Day 1 of OLP through the end of OLP (approximately 3 years)|Any inebilizumab population included all participants who received at least one dose of inebilizumab either in the RCP or OLP.|||Annualized attack rate|||Number
2597233|NCT02200770|Secondary|Number of NMOSD-related In-patient Hospitalizations During RCP|Participants with relapsing NMOSD have recurrent attacks that can be severe and result in blindness, paralysis, and even death and consequently, such attacks frequently result in in-patient hospitalizations. In-patient hospitalization is defined as a stay in hospital that goes beyond midnight of the first day of admission.|Day 1 (Baseline) through Day 197|The ITT population included all participants who were randomized and grouped according to their randomized treatment. Participants with in-patient hospitalization were analyzed for this outcome measure.|||Number of In-patient Hospitalizations||Standard Deviation|Mean
2597234|NCT02200770|Secondary|Cumulative Number of Active Magnetic Resonance Imaging (MRI) Lesions During RCP|The number of new gadolinium-enhancing lesions and new or enlarging T2 lesions were measured by MRI of the brain, optic nerve, and spinal cord.|From Screening (Day -28) to Day 197|The ITT population included all participants who were randomized and grouped according to their randomized treatment. Participants with observed MRI lesions were analyzed for this outcome measure.|||Number of lesions||Standard Deviation|Mean
2597235|NCT02200770|Secondary|Change From Baseline in Low-Contrast Visual Acuity Binocular Score to the Last Visit of RCP|Low-contrast visual acuity test is used to determine the number of letters that can be read on a standardized low-contrast Landolt C Broken Rings Chart held at a distance of 3 meters. Binocular score is the number of letters read correctly on an eye chart using both eyes simultaneously. The total score ranges from 0-70. Higher score indicates better vision.|Day 1 (Baseline) through Day 197|The ITT population included all participants who were randomized and grouped according to their randomized treatment. Participants with low contrast visual acuity binocular score were analyzed for this outcome measure.|||Score on scale||Standard Error|Least Squares Mean
2597236|NCT02200770|Secondary|Percentage of Participants With Worsening in Expanded Disability Severity Scale (EDSS) Score From Baseline to the Last Visit of RCP|EDSS and its associated functional system (FS) score provide a system for quantifying disability and monitoring changes in the level of disability over time. EDSS is a scale for assessing neurologic impairment in multiple sclerosis (MS). It consists of 7 FS (visual FS, brainstem FS, pyramidal FS, cerebellar FS, sensory FS, bowel and bladder FS, and cerebral FS) which are used to derive EDSS score ranging from 0 (normal neurological exam) to 10 (death from MS). A negative change from baseline indicates improvement. A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more.|Day 1 (Baseline) through Day 197|The ITT population included all participants who were randomized and grouped according to their randomized treatment.|||Percentage of Participants|||Number
2597237|NCT02200770|Primary|Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During Randomized Controlled Period (RCP)|The NMOSD attack is defined as the presence of new or worsening symptom(s) related to NMOSD that meet at least one of the 18 protocol-defined attack criteria. These criteria were developed in conjunction with a panel of disease experts and with Food and Drug Administration input, and were intended to be clinically meaningful, objective, quantifiable, and able to be used worldwide. Only attacks positively adjudicated by the AC were used for the primary analysis.|Day 1 (Baseline) through Day 197|The ITT population included all participants who were randomized and grouped according to their randomized treatment.|||Days||95% Confidence Interval|Median
2597238|NCT02200614|Secondary|Time to First Symptomatic Skeletal Event (SSE)|The time to the first SSE was defined as the time from randomization to the occurrence of the first SSE.|From randomization until last study treatment (assessed every 4 months) (approximately 48 months)||||months||95% Confidence Interval|Median
2597239|NCT02200614|Secondary|Time to Initiation of First Cytotoxic Chemotherapy for Prostate Cancer|The time to cytotoxic chemotherapy was defined as the time from randomization to the start of the first cytotoxic chemotherapy cycle.|From randomization until last study treatment (assessed every 4 months) (approximately 48 months)||||months||95% Confidence Interval|Median
2597240|NCT02200614|Secondary|Time to Pain Progression|Time to pain progression (PP) is defined as time from randomization to pain progression, where progression is defined as an increase of 2 or more points from baseline in question 3 of the Brief Pain Inventory-Short Form questionnaire (BPI-SF) related to the worst pain in the last 24 hours taken as a 7-day average for post-baseline scores, or initiation of short or long-acting opioids for pain, whichever comes first. Initiation or change in the use of other non-opioid analgesics is not used in the analysis of pain progression.|From randomization until last study treatment (assessed every 4 months) (approximately 48 months)||||months||95% Confidence Interval|Median
2597241|NCT02200614|Secondary|Overall Survival|Overall Survival (OS) was defined as the time from randomization to death due to any cause.|From randomization of the first subject to the time approximatively 140 death events were observed (approximately 48 months)||||months||95% Confidence Interval|Median
2597243|NCT02200536|Secondary|Change in Mother's Reported Bottle-feeding Practice.|Change in mother's reported bottle-feeding practice was measured by comparing mother's reported bottle-feeding practice at follow up and baseline. Change was present when mother's reported no bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline. Change was not present when mother's reported bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline.|Baseline (T0) and after one month (T1)||||percentage of mothers|||Number
2597244|NCT02200536|Primary|Change in Mother's Reported Infant's Twice-a-day Tooth Brushing Practice.|Change in mother's reported infant's twice-a-day tooth brushing practice was measured by comparing mother's reported infant's twice-a-day tooth brushing practice at follow up and baseline. Change was present when mother's reported infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline. Change was not present when mother's did not report infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline.|Baseline (T0) and after one month (T1)||||percentage of mothers|||Number
2597245|NCT02200510|Primary|Change From Baseline on Disease Self-efficacy Measure at 6 Weeks|"Name of Measure: Sickle Cell Self-Efficacy Scale (SCSES). Construct: sickle cell self-efficacy (disease specific self-efficacy) 9 item measure of sickle cell disease self-efficacy (likert scale from 1 [not at all sure] to 5 [very sure]) developed by Edwards (see References).~Responses on items are summed to compute a total score. Minimum score: 9 Maximum score: 45 Higher scores represent higher sickle cell self-efficacy (better outcome)."|baseline, 6 weeks (post-intervention)|Participants with completed baseline and post measures.|||units on a scale||Standard Deviation|Mean
2597246|NCT02200458|Primary|Number of Participants for Whom Successful Visualization of Vasculature Was Achieved||One day||||participants|||Number
2597247|NCT02200328|Secondary|Determine Differences in Clostridium Difficile Diarrhea Incidence Between Patients on Piperacillin/Tazobactam vs. Patients on Ciprofloxacin.||30 days|0 participants were analyzed due to large number of patients not complying to the instructions and loss to follow up.||||||
2597248|NCT02200328|Primary|The Incidence of Clostridium Difficile Diarrhea in Both Study Groups at 30 Days Post Broad Spectrum Antibiotic Use.||30 days|0 participants were analyzed due to large number of patients not complying to the instructions and loss to follow up.||||||
2597249|NCT02200211|Other Pre-specified|Safety Analysis: Distribution of Maximum Frequency of Diplopia Reported Across Study Follow-up (Participant-reported)|A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.|Across study follow-up visits, up to 16 weeks|Participants who completed a diplopia assessment at any follow-up visit (4-week, 8-week, 12-week, 16-week) during the study.|||Participants|||Count of Participants
2597250|NCT02200211|Other Pre-specified|Safety Analysis: Distribution of Maximum Frequency of Diplopia Reported Across Follow-up (Parent-reported)|A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.|Across study follow-up visits, up to 16 weeks|Participants whose parent completed a diplopia assessment at any follow-up visit (4-week, 8-week, 12-week, 16-week)|||Participants|||Count of Participants
2597251|NCT02200211|Other Pre-specified|Safety Analysis: Distribution of Diplopia Frequency at 16 Weeks (Participant-reported)|A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.|16 weeks|Participants who completed a 16-week diplopia assessment.|||Participants|||Count of Participants
2597252|NCT02200211|Other Pre-specified|Safety Analysis: Distribution of Diplopia Frequency at 16 Weeks (Parent-reported)|A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.|16 weeks|Participants whose parent completed a 16-week diplopia assessment.|||Participants|||Count of Participants
2597253|NCT02200211|Other Pre-specified|Safety Analysis: Development of a New Tropia and/or Worsening of a Pre-existing Deviation by 10 pd|"Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter).~Participants were classified according to whether they met the any of the following criteria at the 16-week visit: development of a new tropia (measured by SPCT) and/or worsening of a pre-existing deviation by 10 prism diopters (pd) measured by SPCT."|16 weeks|Participants who completed the 16-week visit (regardless of whether or not the visit was completed within the pre-specified analysis window).|||Participants|||Count of Participants
2597254|NCT02200211|Other Pre-specified|Safety Analysis: Change in Fellow-eye Visual Acuity From Baseline (Older Cohort)|"Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.~For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.~The change in fellow-eye visual acuity (letters) from baseline (positive values indicate improvement) was computed by treatment group, adjusting for baseline visual acuity."|16-week visit|Participants who completed the 16-week visit (regardless of whether or not the visit was completed within the pre-specified analysis window).|||Letters||95% Confidence Interval|Mean
2597275|NCT02200211|Primary|Mean Amblyopic Eye Visual Acuity (Younger Cohort)|"Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.~For the younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA."|16 Weeks from baseline|Visual acuity analyses included only data from participants who completed the 16-week visit within the predefined analysis window (14 to <20 weeks after randomization).|||LogMAR||Standard Deviation|Mean
2597255|NCT02200211|Other Pre-specified|Safety Analysis: Change in Fellow-eye Visual Acuity From Baseline (Younger Cohort)|"Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.~For the younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA. Change in VA is computed as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and 16-week acuities (logMAR) multiplied by 10.~For this safety analysis, the change in fellow-eye visual acuity (logMAR lines) was computed by treatment group, adjusting for baseline visual acuity."|16-week visit|Participants who completed the 16-week visit (regardless of whether or not the visit was completed within the pre-specified analysis window).|||logMAR lines||95% Confidence Interval|Mean
2597256|NCT02200211|Other Pre-specified|Safety Analysis: Distribution of the Change in Fellow-eye Visual Acuity From Baseline|Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic ATS-HOTV visual acuity protocol for children <7 years and the E-ETDRS visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. The change in visual acuity is analyzed as logMAR lines for the younger cohort and as letters for the older cohort.|16-week visit|Participants who completed the 16-week visit (regardless of whether or not the visit was completed within the pre-specified analysis window).|||Participants|||Count of Participants
2597257|NCT02200211|Other Pre-specified|Participants Who Received Non-protocol, Alternative Treatment During the Study|"Participants who were randomly assigned to binocular treatment were prescribed 1 hour of game play per day, 7 days a week while those assigned to the patching group were prescribed 2 hours of daily patching, 7 days per week.~The number of participants who received non-protocol, alternative treatment was tabulated by treatment group."|Entire study period, up to 16 weeks|All randomized participants in the study.|||Participants|||Count of Participants
2597258|NCT02200211|Other Pre-specified|Percentage of Participants Reporting >75% of Prescribed Treatment Completed (Subjective Measures of Adherence)|"Participants who were randomly assigned to binocular treatment were prescribed 1 hour of game play per day, 7 days a week while those assigned to the patching group were prescribed 2 hours of daily patching, 7 days per week.~Parents were asked to record the amount of time that the participant played the binocular game (binocular treatment group) or wore the patch (patching group) each day on a calendar.~At each study visit, the investigator estimated the frequency and duration of treatment that the participant completed based on the parent-reported calendars and discussion with the participant and/or parent(s). For analysis, the percentage of prescribed treatment completed was calculated as the total number of reported hours of treatment completed since baseline divided by the total number of prescribed hours (refer to the intended treatment dose/frequency listed above) since baseline."|16 Weeks from baseline|The descriptive analysis included data from participants who completed the 16-week visit within the predefined analysis window (14 to <20 weeks after randomization).|||Participants|||Count of Participants
2597259|NCT02200211|Secondary|Binocular Treatment Group: Median Adherence With Prescribed Game Play (iPad Log File Data)|"Participants assigned to binocular treatment were prescribed the binocular falling blocks game for 1 hour per day (allowing division into shorter sessions), 7 days per week for 16 weeks, with instructions to perform therapy a minimum of 4 days per week if unable to play for 7 days per week.~The iPad device automatically recorded duration of game play, fellow-eye contrast, and performance.~Adherence was calculated as the % of prescribed treatment actually completed: total hours of game play since baseline divided by the total prescribed hours (based on intended dose of 1 hour a day, 7 days per week) since baseline."|Entire study period, up to 16 weeks|The descriptive analysis included data from participants in the binocular treatment group who had log file data available.|||% of prescribed treatment completed||Inter-Quartile Range|Median
2597260|NCT02200211|Secondary|Binocular Treatment Group: Adherence and Fellow-eye Contrast (iPad Log File Data)|"Participants assigned to binocular treatment were prescribed the binocular falling blocks game for 1 hour per day (allowing division into shorter sessions), 7 days per week for 16 weeks, with instructions to perform therapy a minimum of 4 days per week if unable to play for 7 days per week.~The iPad device automatically recorded duration of game play, fellow-eye contrast, and performance. Adherence was calculated as the total hours of game play since baseline divided by the total prescribed hours (based on intended dose of 1 hour a day, 7 days per week) since baseline.~The fellow-eye contrast was initially set to 20% (amblyopic eye always at 100%) and automatically increased or decreased by 10% increments (lowest level of 10%) or left unchanged from the last contrast level, based on the previous day's game play duration (at least 30 minutes required for contrast change) and performance (increased if scored 1000 points or more).~Post hoc analysis: 4-week fellow-eye contrast."|Entire study period, up to 16 weeks|The descriptive analysis included data from participants in the binocular treatment group who had log file data available.|||Participants|||Count of Participants
2597261|NCT02200211|Secondary|Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)|"Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity.~Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000 ) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.~For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 16-week stereoacuity scores."|Baseline and 16 weeks|The analysis included a subset of participants with no history of strabismus who completed stereoacuity testing at both baseline and the 16-week visit (regardless of whether or not the exam was completed within the pre-specified analysis window).|||Participants|||Count of Participants
2597308|NCT02199574|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-infinity))||From time of study drug administration through Day 7 postdose||||hours*ng/mL||Standard Deviation|Mean
2597262|NCT02200211|Secondary|Distribution of Change in Stereoacuity Scores From Baseline|"Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity.~Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000 ) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.~For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 16-week stereoacuity scores."|Baseline and 16 weeks|The analysis included all participants who completed stereoacuity testing at both baseline and the 16-week visit (regardless of whether or not the exam was completed within the pre-specified analysis window).|||Participants|||Count of Participants
2597263|NCT02200211|Secondary|Distribution of Stereoacuity Scores (Participants With no History of Strabismus)|"Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.~Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted."|16 weeks|The analysis was limited to a subset of participants (no history of strabismus) who completed a 16-week exam regardless of whether or not the exam was completed within the pre-specified analysis window.|||Participants|||Count of Participants
2597264|NCT02200211|Secondary|Median Stereoacuity Score (Seconds of Arc)|"Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity.~Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.~A logarithm base 10 transformation was used to convert stereoacuity scores (seconds of arc) to the log scale (conversion reference listed below), which was used to calculate descriptive statistics. Results of the descriptive analyses are reported as seconds of arc."|16 weeks|"Participants who completed stereoacuity testing at the 16-week visit (regardless of whether or not the visit was completed within the pre-specified analysis window).~Descriptive analyses were repeated for a subset of participants with no history of strabismus."|||Seconds of arc||Full Range|Median
2597265|NCT02200211|Secondary|Distribution of Stereoacuity Scores|"Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods.~Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted."|16 weeks|The analysis included all participants who completed a 16-week exam regardless of whether or not the exam was completed within the pre-specified analysis window.|||Participants|||Count of Participants
2597266|NCT02200211|Secondary|Older Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups|"Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.~For the analyses in the older cohort, the level of VA is measured as letter scores (previously defined) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.~Subgroup factors of interest were pre-specified except for baseline stereoacuity (nil, better than nil)."|Baseline and 16 weeks|Visual acuity analyses included only data from participants who completed the 16-week visit within the predefined analysis window (14 to <20 weeks after randomization).|||Letters||Standard Deviation|Mean
2597267|NCT02200211|Secondary|Younger Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups|"Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.~For the younger cohort, the level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined, positive values indicate improvement), For both descriptive and formal subgroup analyses, all subgroup factors were pre-specified except for baseline stereoacuity (nil, better than nil). We performed post hoc descriptive analyses to explore treatment effect by baseline age (5 to <7 yrs, 7 to <13 yrs) and prior amblyopia treatment (yes/no)."|Baseline and 16 weeks|Visual acuity analyses included only data from participants who completed the 16-week visit within the predefined analysis window (14 to <20 weeks after randomization). Formal subgroup analyses are adjusted for baseline covariates of visual acuity and age.|||LogMAR lines||Standard Deviation|Mean
2597309|NCT02199574|Primary|Apparent Terminal Elimination Half-life||From time of study drug administration through Day 7 postdose||||hours||Standard Deviation|Mean
2597310|NCT02199574|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC(0-t))||From time of study drug administration through Day 7 postdose||||hours*ng/mL||Standard Deviation|Mean
2597311|NCT02199574|Primary|Time to Maximum Plasma Concentration (Tmax)||From time of study drug administration through Day 7 postdose||||hours||Full Range|Median
2597268|NCT02200211|Secondary|Time Course of Visual Acuity Improvement|"Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.~For the younger cohort, the level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7, higher values indicate poorer VA) and change in VA from baseline as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and follow-up acuities (logMAR) multiplied by 10."|Baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks|Analysis included participants with at least one follow-up visit (completed within the analysis window). There were 6 participants (4 in the binocular group, 2 in the patching group) who were excluded from the time course analysis because they did not have any follow-up exams.|||logMAR lines||Standard Deviation|Mean
2597269|NCT02200211|Secondary|Number of Participants With Resolution of Amblyopia|"Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.~The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) for the younger cohort and as letter scores (previously defined) for the older cohort.~Resolution of amblyopia was defined as having an amblyopic-eye VA of 20/25 or better (≥ 78 letters if E-ETDRS) and within 1 logMAR line (5 letters if E-ETDRS) of the fellow eye VA."|16-week visit|Analysis was limited to participants who completed the 16-week visit within the pre-specified analysis window (14 to <20 weeks after randomization).|||Participants|||Count of Participants
2597270|NCT02200211|Secondary|Number of Participants With Amblyopic-eye VA Improvement of 2 or More logMAR Lines (10 or More Letters if E-ETDRS) From Baseline|"Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.~Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).~Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined)."|Baseline and 16-week visit|Analysis was limited to participants who completed the 16-week visit within the pre-specified analysis window (14 to <20 weeks after randomization).|||Participants|||Count of Participants
2597271|NCT02200211|Primary|Distribution of Amblyopic-eye Visual Acuity|"Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.~Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).~Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined)."|At 16 weeks|Participants that completed 16-week visit within pre-specified analysis window (148 to 196 days after randomization)|||Participants|||Count of Participants
2597272|NCT02200211|Primary|Distribution of Change in Amblyopic-eye Visual Acuity|"Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.~Younger cohort: The level of VA is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (previously defined) and change in VA from baseline as logMAR lines (previously defined).~Older cohort: The level of VA is measured as letter scores (previously defined) and VA change from baseline is measured in letters (previously defined)."|Baseline and 16 weeks||||Participants|||Count of Participants
2597273|NCT02200211|Primary|Mean Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years)|"Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.~For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up."|16 weeks|Participants that completed 16-week visit within pre-specified analysis window (148 to 196 days after randomization)|||letters||Standard Deviation|Mean
2597274|NCT02200211|Primary|Mean Change in Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years)|"Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.~For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up."|Baseline and 16 weeks|Mean change in amblyopic-eye visual acuity from baseline to 16 weeks from participants who completed 16-week visit within pre-specified analysis window (148 to 196 days after randomization)|||letters||95% Confidence Interval|Mean
2597312|NCT02199574|Primary|Maximum Plasma Concentration (Cmax)||From time of study drug administration through Day 7 postdose||||ng/mL||Standard Deviation|Mean
2597516|NCT02196714|Secondary|Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 Hours|Safety Population|||Ratio||Standard Deviation|Mean
2597276|NCT02200211|Primary|Change in Distance Visual Acuity From Baseline in the Younger Cohort (5 to <13 Years)|"Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the electronic Amblyopia Treatment Study single-surround HOTV (ATS-HOTV) visual acuity protocol for children <7 years and the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes.~For the younger cohort, the level of visual acuity is analyzed in the log of the Minimum Angle of Resolution (logMAR) scale (approximate range: -0.2 to 1.7) such that higher scores indicate poorer VA. Change in VA is computed as logMAR lines (positive values indicate improvement), defined as the difference between the enrollment and 16-week acuities (logMAR) multiplied by 10."|Baseline and 16 weeks|Visual acuity analyses included only data from participants who completed the 16-week visit within the predefined analysis window (14 to <20 weeks after randomization), analysis is adjusted for baseline covariates of age and visual acuity.|||LogMAR lines||95% Confidence Interval|Mean
2597277|NCT02200055|Secondary|Amount of Intraoperative Fluids|The amount of IV fluids each patient received during the surgical procedure|intraoperative measurement|The population of participants with recorded data on the amount of IV fluids used during surgery|||mL||Standard Deviation|Mean
2597278|NCT02200055|Secondary|American Society of Anaesthesiologists Physical Status Classification Scale|"A classification scale to assess the fitness of patients before surgery~The ASA score is a subjective assessment of a patient's overall physical health. The scale ranges from 1 to 5.~ASA 1 A normal healthy patient. ASA 2 A patient with mild systemic disease. ASA 3 A patient with severe systemic disease. ASA 4 A patient with severe systemic disease that is a constant threat to life. ASA 5 A moribund patient who is not expected to survive"|preoperative|An ASA classification was recorded for each participant|||units on a scale||Standard Deviation|Mean
2597279|NCT02200055|Secondary|Study Characteristics of Participants: Body Mass Index|Body Mass Index was recorded for each study participant at baseline|baseline measurement|Baseline BMI was recorded for each participant|||kg/m^2||Standard Deviation|Mean
2597280|NCT02200055|Secondary|Urine Output|Overall urine output was collected preoperative|preoperative measurement|This population of participants recorded their urine output under preoperative conditions|||mL||Standard Deviation|Mean
2597281|NCT02200055|Secondary|Daily Fluid Balance (Intakes and Outputs)|Each participant had a daily calculated fluid balance taken during the course of an approximate 8 day period|Sum of intakes and outputs each day while inpatient, an average of 8 days|This was the final amount of participants who met all study eligibility requirements|||mL||Standard Deviation|Mean
2597282|NCT02200055|Secondary|Percent Intracellular Water Volume|Intracellular water volume was recorded for each participant before surgical procedure.|Preoperative measurement|This population includes data on participants with recorded intracellular water volume measurements|||percent of total water volume||Standard Deviation|Mean
2597283|NCT02200055|Secondary|Percent Extracellular Water Volume|Extracellular water volume was recorded for each participant 6 hours following the surgical procedure.|6 hours postoperative measurement|This population contains data with extracellular water volume measurements taken post-operative|||percent of total water volume||Standard Deviation|Mean
2597284|NCT02200055|Secondary|Percent Intracellular Water Volume|Intracellular water volume was recorded for each participant 6 hours following the surgical procedure.|6 hour postoperative measurement||||percent of total water volume||Standard Deviation|Mean
2597285|NCT02200055|Secondary|Percent Extracellular Water Volume|Extracellular water volume was recorded for each participant before surgical procedure.|preoperative measurement|This is the final number of participants who met all study eligibility requirements|||percent of total water volume||Standard Deviation|Mean
2597286|NCT02200055|Primary|Bioimpedance Assessment|Postoperative bioimpedance assessment measurements were recorded for each participant. One average across this time frame was recorded.|Average measurement, in ohms, taken daily for approximately 8-10 days|This population of participants has their bioimpedance assessment taken daily for approximately 8-10 days postoperative. One average across this time frame was recorded|||ohms||Standard Deviation|Mean
2597287|NCT02200055|Primary|Bioimpedance Assessment|Bioimpedance assessment measurements were recorded for each participant six hours following the surgical procedure|6 hours postoperative measurement||||ohms||Standard Deviation|Mean
2597288|NCT02200055|Primary|Bioimpedance Assessment|Bioimpedance assessment measurements were recorded for each participant before the surgical procedure|preoperative measurement|This is the population of participants with bioimpedance measurements taken preoperative|||ohms||Standard Deviation|Mean
2597289|NCT02200042|Secondary|Regional Progression Defined as Progression or Existing or Appearance of New Nodal Disease||From randomization to last follow-up. Analysis occurs after all patients have been on study for at least two years.|No patients have outcome data.||||||
2597290|NCT02200042|Secondary|Progression-free Survival (PFS)||From randomization to last follow-up. Analysis occurs after all patients have been on study for at least two years.|No patients have outcome data.||||||
2597291|NCT02200042|Secondary|Local Progression||From randomization to last follow-up. Analysis occurs after all patients have been on study for at least two years.|No patients have outcome data.||||||
2597292|NCT02200042|Secondary|Incidence of Adverse Events Evaluated Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0||From randomization to last follow-up. Analysis occurs after all patients have been on study for at least two years.|No patients have outcome data.||||||
2597293|NCT02200042|Secondary|Distant Metastases||From randomization to last follow-up. Analysis occurs after all patients have been on study for at least two years.|No patients have outcome data.||||||
2597294|NCT02200042|Primary|Overall Survival|Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From randomization to last follow-up. Analysis occurs after all patients have been on study for at least two years.|No patients have outcome data.||||||
2597295|NCT02199964|Other Pre-specified|Conjunctival Goblet Cells|The number of conjunctival goblet cells measured in impression cytology at screening/baseline before and after low humidity exposure at the baseline and Day 42 visits. No (zero) subjects were analyzed because the assay was not performed and data was not collected because the study was terminated due to loss of funding.|6 weeks|||||||
2597296|NCT02199964|Secondary|Eye Irritation Symptoms|The mean difference in subject's scoring of eye irritation symptoms using a VAS (visual analog scale) questionnaire before and after the environmental challenge after treatment at Visit 3/Day 42 when patients were subjected to a 90-minute low humidity stress. Symptoms were graded on a 4 question VAS 0-5 for each question, with scores summed for all questions for a total score that ranges from 0 (minimum) to 20 (maximum) for the pre and post challenge questionnaires. The outcome measure is the difference in the post to pre total score ranging from -20 (maximum improvement) to 20 (maximum worsening). A minus difference indicated the subject had lower irritation symptoms following the lower humidity challenge, while a positive difference indicated the subject had greater irritation following the low humidity challenge on Day 42.|6 weeks||||units on a scale||Standard Deviation|Mean
2597297|NCT02199964|Primary|Corneal Fluorescein Staining|The mean difference in corneal staining using the adjusted CCLR global staining score before and after the environmental challenge at visits baseline and Visit 3/Day 42 when patients were subjected to a 90-minute low humidity stress. Corneal fluorescein staining was graded 0-100 in 5 zones on the cornea. The scores ranged from 0 (minimum) to 500 (maximum). A higher score indicates there was greater cornea disease induced by the low humidity stress on Day 42|6 weeks|Due to loss of funding, this study was not completed and enrollment ended. Data from only 2 subjects per group was analyzed|||units on a scale||Standard Deviation|Mean
2597298|NCT02199795|Secondary|Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment|"The MEFAP is a measure of functional ambulation, measuring the time to ambulate through 5 common environmental terrains: 1) 5-meter walk on a hard floor, 2) 5-meter walk on a carpeted floor, 3) rise from a chair, 3-meter walk, return to seated position, 4) standardized obstacle course (bricks to step over), 5) stair ascent and descent. The five times subscores were added to derive a total time.~Lower times are considered to be a better outcome.~For each individual, the MEFAP completion time prior to treatment was subtracted from the MEFAP completion time at end of the 6-week treatment. Then for each treatment group, these change values were averaged."|Baseline and End of Treatment (6 weeks)||||seconds||Standard Deviation|Mean
2597299|NCT02199795|Secondary|Change in Ankle Movement Tracking Error at End of Treatment|"Ankle dorsiflexion angle was measured continuously using an electrogoniometer. The subject was seated in front of a computer screen which displayed a 30-sec long sine-wave trace scrolling right to left across the screen. The peak to peak amplitude of the sine wave was set equal to the participant's achievable active range of ankle movement and put on a scale of 0 to 100. Three 30-sec trials were run in which the participant's task was to trace the sine wave by moving their paretic ankle. Error was calculated as the average vertical distance between the sine wave and the ankle angle. The lowest error across three trials was taken as the error for that time point.~Lower errors are considered to be better outcomes.~For each participant, the error prior to treatment was subtracted from the error at end of the 6-week treatment. Then for each treatment group, these change scores were averaged. A negative change in error scores is considered an improvement."|Baseline and End of Treatment (6 weeks)||||units on a scale||Standard Deviation|Mean
2597300|NCT02199795|Secondary|Change in 10-Meter Walk Test|Time to walk 10 m was measured using a stop-watch. For each individual, the time to walk 10 m prior to treatment was subtracted from the time to walk 10 m at end of the 6-week treatment. Then for each treatment group, these changes in time were averaged.|Baseline and End of Treatment (6 weeks)||||seconds||Standard Deviation|Mean
2597301|NCT02199795|Primary|Change in Lower Extremity Fugl-Meyer Score at End of Treatment|"The Lower Extremity Fugl-Meyer (LEFM) Assessment is a measure of lower limb motor impairment. Participants are asked to attempt to perform a list of isolated and simultaneous movements of the hip, knee, and ankle that take into account synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt is graded on a 3-point ordinal scale (0, cannot perform; 1, perform partially; and 2, perform fully) and these subscores are summed to provide a maximum score of 34, minimum score of 0 (i.e., full scale range 0-34).~Higher scores are considered to be a better outcome. For each individual, the score prior to treatment was subtracted from the score at end of the 6-week treatment. Then for each treatment group, these change scores were averaged."|Baseline and End of Treatment (6 weeks)||||units on a scale||Standard Deviation|Mean
2597302|NCT02199717|Primary|Sedentary Time|To determine if the amount of time spent in sedentary time on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.|7 days|All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups were examined in exploratory analyses.|||minutes per day||Standard Deviation|Mean
2597303|NCT02199717|Primary|MVPA|To determine if the amount of time spent performing moderate to vigorous physical activity (MVPA) engaged in on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.|7 days|All statistical analyses were completed using SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Descriptive statistics such as mean (± SD) and range were calculated and provided for demographic variables, accelerometry variables and questionnaire outcomes. Differences between the two groups were examined in exploratory analyses.|||minutes per day||Standard Deviation|Mean
2597304|NCT02199652|Secondary|Insomnia Severity Index|"This is a self report scale, with 7 items scored 0-4, producing a total score range 0-28.~Higher scores are worse Score 0-7 is interpreted as no insomnia problem 8-14 subclinical insomnia 15-21 moderate insomnia 22-28 severe insomnia"|8 weeks||||units on a scale||Standard Error|Least Squares Mean
2597305|NCT02199652|Secondary|Disturbing Dreams and Nightmare Severity Index|This is a self report scale, with 5 items, producing a total score with a range from 0-37. Higher scores are worse. A score greater than 10 is considered to indicate a clinically relevant problem with nightmares and/or bad dreams|8 weeks||||units on a scale||Standard Error|Least Squares Mean
2597306|NCT02199652|Primary|Change Score for Scale for Suicide Ideation|"There will be data on the Scale for Suicide Ideation collected at the end of each week of treatment up to 8 weeks. Our apriori primary outcome is the change score in Scale for Suicide Ideation from baseline to the last observation.~This is a self report scale, with 19 items which measure present suicidality, each scored 0-2.~The total scale has a range from 0-38, with higher scores being worse"|change score from baseline to last observation, up to 8 weeks||||units on a scale||Standard Error|Least Squares Mean
2597307|NCT02199574|Primary|The Apparent Terminal Elimination Rate Constant (λz)||From time of study drug administration through Day 7 postdose||||1/hours||Standard Deviation|Mean
2597313|NCT02199509|Secondary|Percent Change of the Sum of Eyes and Upper Face, Lower Face and Jaw and Tongue Subscores of the GDS Rating Scale|The Global Dystonia Severity Scale provides a severity rating for ten body regions, i.e.,1) eyes and upper face, 2) lower face, 3) jaw and tongue, 4) larynx, 5) neck, 6) shoulder and proximal arm, 7) distal arm and hand including elbow, 8) pelvis and upper leg, 9) distal leg and foot, and 10) trunk. Each body area is rated from 0 to 10, with 0 representing no dystonia present in that body area and 10 representing severe dystonia. The secondary outcome measure includes the sum of the eyes and upper face, lower face and jaw and tongue subscores of the GDS rating scale and represents the percent change from baseline to either 3 and 6 weeks or 11 and 14 weeks (representing the end of the three week titration period (3 weeks and 11 weeks) and the post-3 week period (6 weeks and 14 weeks) at the maximum tolerated dose for Levetiracetam or Placebo). The total range of these combined sub scores is 0-30, with higher scores indicating more severe dystonia and 0 indicating absence of|3, 6, 11 and 14 compared to baseline||||Percentage of change||Standard Deviation|Mean
2597314|NCT02199509|Secondary|Percent Change of the Sum of the Eyes, Mouth, Speech and Swallowing Subscores of Burke-Fahn-Marsten Dystonia Rating Scale (BFM)|The Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) is a measure of dystonia severity. The scale consists of evaluation of ten body parts (eyes, mouth, speech, swallowing, neck, trunk, right arm, right leg, left arm and left leg). The severity and provoking factors for each part are rated using a 5-point scale. These range from 0 (indicating no dystonia) to 4 (indicating the presence of dystonia at rest). The secondary outcome measure includes the sum of the eyes, mouth, speech and swallowing subscores and represents the percent change from baseline to either 3 weeks or 11 weeks (representing the end of the three week titration period up to the maximum tolerated dose for Levetiracetam or Placebo). The total range for these combined sub scores is 0-16, with higher scores indicating more severe dystonia and 0 indicating absence of dystonia.|3 and 11 weeks compared to baseline||||percent change||Standard Deviation|Mean
2597315|NCT02199509|Primary|Percent Change of the Sum of the Eyes, Mouth, Speech and Swallowing Subscores of the Burke-Fahn-Marsden (BFM) Dystonia Scale.|The Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) is a measure of dystonia severity. The scale consists of evaluation of nine body parts (eyes, mouth, speech, swallowing, neck, trunk, right arm, right leg, left arm and left leg). The severity and provoking factors for each part are rated using a 5-point scale. These range from 0 (indicating no dystonia) to 4 (indicating the presence of dystonia at rest). The primary outcome measure includes the sum of the eyes, mouth, speech and swallowing subscores and represents the percent change from baseline to either 6 weeks or 14 weeks (representing the end of the 3 week period at the maximum tolerated dose for Levetiracetam or Placebo). The total range for these combined sub scores is 0-16, with higher scores indicating more severe dystonia and 0 indicating absence of dystonia.|6 and 14 weeks compared to baseline||||percent change||Standard Deviation|Mean
2597316|NCT02199197|Primary|Number of Participants With Adverse Events|Adverse Events were assessed from start of Radium Ra 223 Dichloride or Enzalutamide treatment (whichever was started first) through 30 days after the last dose of either drug or until start of a new anti-cancer therapy, whichever came first. Adverse events were assessed using the Common Terminology for Adverse Events (CTCAE) version 4.0. Each event was assigned a grade (1-5), with lower grades indicating milder events. All adverse events were recorded, regardless of attribution to study treatment. Reported below are the number of patients who experienced any grade 3-5 non-hematological AE. A full listing of AEs affecting 5% or more participants are listed in the Adverse Events module of the Results section.|From first dose of study treatment to 30 days following last dose (approximately 7 months)||||Participants|||Count of Participants
2597317|NCT02199197|Primary|Fold Change in Serum N-telopeptides From Baseline|Patients had serum N-telopeptide labs drawn prior to the start of treatment and at the End of Treatment visit or at disease progression, whichever occurred first. The mean and standard deviation of the differences were calculated on a log 2 scale. Fold changes (post/pre) and 95% confidence intervals are reported.|From prior to start of treatment to end of treatment or disease progression (approximately 6 months)|Per study protocol, only randomized patients with bone marker level measurements at baseline and Cycle 3 Day 1 will be evaluable for the primary efficacy outcome. 8 patients were assigned to Radium + Enzalutamide without randomization and were excluded from analysis. 2 patients on Enzalutamide alone did not reach Cycle 3 Day 1 and were excluded.|||fold change||95% Confidence Interval|Geometric Mean
2597318|NCT02199080|Secondary|Atrial Thrombus Exclusion (ATE) Score|"The following thromboembolic risk factors mark 1 point if present in patient:~hypertension = 1 point~cardiac insufficiency = 1 point~history of stoke = 1 point~d-dimer level >270ng/mL = 1 point The sum corresponds to the ATE score"|48 hours before ablation||||Participants|||Count of Participants
2597319|NCT02199080|Secondary|Risk Factors|variables related to the presence of atrial thrombus|48 hours before ablation||||Participants|||Count of Participants
2597320|NCT02199080|Secondary|CHADS2 Score|CHADS2 score (congestive heart failure=1, hypertension=1, diabetes mellitus=1, history of stroke or transient ischemic attack=1, and age under 75=1)|48 hours before ablation||||Participants|||Count of Participants
2597321|NCT02199080|Primary|Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound||up to 48 hours before ablation||||Participants|||Count of Participants
2597322|NCT02199041|Secondary|Number of Participants With Transplant-related Morbidity|"Any patient who had adverse events listed either as probable or definite in the first 100 days post-transplant are counted as transplant-related morbidity. The cumulative incidence of transplant-related morbidity will be estimated using the Kalbfleisch-Prentice method. Deaths before day 100 are the competing risk events.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced at least one-transplant-related morbidity is provided."|100 days after transplantation||||Participants|||Count of Participants
2597323|NCT02199041|Secondary|Number of Participants With Transplant-related Mortality (TRM)|"TRM is any death in remission and related to protocol therapy. The cumulative incidence of TRM was estimated using the Kalbfleisch-Prentice method. Deaths before day 100 because of other reasons are the completing events.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced TRM is provided."|100 days after transplantation||||Participants|||Count of Participants
2597517|NCT02196714|Secondary|Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 Hours|Safety Population|||10^9cells/L||Standard Deviation|Mean
2597324|NCT02199041|Secondary|Number of Participants With Secondary Graft Failure|"The cumulative incidence of secondary graft failure will be estimated using the Kalbfleisch-Prentice method. Deaths due to toxicity and relapse before day 100 are the competing events.~Secondary graft failure or graft rejection will be defined as no evidence of donor chimerism by umbilical cord blood (UCB) and/or haploidentical donor (<10%), or too few cells to perform adequate chimerism analysis, in research participants with prior neutrophil engraftment.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced secondary graft failure is provided."|100 days after transplantation||||Participants|||Count of Participants
2597325|NCT02199041|Secondary|Number of Participants by Severity With Chronic Graft Versus Host Disease (GVHD) in the First 100 Days After HCT|"Cumulative incidence of acute and chronic GVHD was estimated using Kalbfleisch-Prentice method. Death is competing risk event. SAS macro (bmacro252-Excel2007\cin) available St. Jude was used for such analysis. Severity of chronic GVHD was evaluated using National Institutes of Health (NIH) Consensus Global Severity Scoring. Mild is considered a better outcome with severe being the worst.~Criteria for grading chronic GVHD:~Mild: 1-2 organs/sites, maximum organ score of 1, and lung score of 1. Moderate: 3 or more organs/sites and maximum organ score of 1 and lung score of 1, OR at least 1 organ/site and maximum organ score of 2 and lung score of 1. Severe: At least 1 organ/site and maximum organ score of 3 and lung score of 2-3.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced chronic GVHD is provided."|100 days after transplantation||||Participants|||Count of Participants
2597326|NCT02199041|Secondary|Number of Participants by Severity With Acute Graft Versus Host Disease (GVHD) in the First 100 Days After HCT|"Cumulative incidence of acute GVHD was estimated using Kalbfleisch-Prentice method. Death is the competing risk event. SAS macro (bmacro252-Excel2007\cin) available at St. Jude was used for analysis. Severity of GVHD and stage were determined using the Clinical Oncology Group (COG) Stem Cell Committee Consensus Guidelines for establishing organ stage and overall grade of acute GVHD. Participants are graded on a scale from I to IV, with I being mild and IV being severe.~Overall Clinical Grade (based on the highest stage obtained):~Grade 0: No stage 1-4 of any organ. Grade I: Stage 1-2 skin and no liver or gut involvement. Grade II: Stage 3 skin, or Stage I liver involvement, or Stage 1 gastrointestinal (GI).~Grade III: Stage 0-3 skin, with Stage 2-3 liver, or Stage 2-3 GI. Grade IV: Stage 4 skin, liver or GI involvement.~Due to early close of study, a small number of patients were enrolled. The number of patients who experienced acute GVHD is provided."|100 days after transplantation||||Participants|||Count of Participants
2597327|NCT02199041|Secondary|Number of Participants With Overall Survival (OS)|"The Kaplan-Meier estimate of OS with relapse, death due to any cause and graft failure as events along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\kme) available in the Department of Biostatistics at St. Jude, where OS = min (date of last follow-up, date of death) - date of hematopoietic cell transplantation (HCT) and all participants surviving after 1 year post-transplant will be considered as censored.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not die at 1 year post-transplant is provided."|One year after transplantation||||Participants|||Count of Participants
2597328|NCT02199041|Secondary|Number of Participants With Event-free Survival (EFS)|"The Kaplan-Meier estimate of EFS with relapse, death due to any cause and graft failure as events along with their standard errors will be calculated using the SAS macro (bmacro251-Excel2007\kme) available in the Department of Biostatistics at St. Jude, where EFS = min (date of last follow-up, date of relapse, date of graft failure, date of death due to any cause) - date of transplant, and all participants surviving at the time of analysis without events will be censored. The number of participants who did not experience any of these events through one year post-transplant is given.~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who did not experience any events defined above is provided."|One year after transplantation||||Participants|||Count of Participants
2597329|NCT02199041|Secondary|Number of Participants With Malignant Relapse|"Relapse was evaluated using standard World Health Organization (WHO) criteria for each disease. The estimate of cumulative incidence of relapse will be estimated using Kalbfleisch-Prentice method. Relapse defined as the recurrence of original disease. Death is the competing risk event. The analysis will be implemented using Statistical Analysis System (SAS) macro (bmacro252-Excel2007\cin).~Due to the early close of the study, a small number of patients were enrolled. Subsequently, the number of patients who experienced malignant relapse is provided"|One year after transplantation||||Participants|||Count of Participants
2597330|NCT02199041|Primary|Number of Participants With Neutrophil Engraftment|Neutrophil engraftment is defined as absolute neutrophil count (ANC) recovery of ≥ 0.5 x 10^9/L (500/mm^3) for three consecutive laboratory values obtained on different days (derived from either donor). Date of engraftment is the date of the first of the three consecutive laboratory values. The number of patients engrafted by day +42 post-transplant is provided.|Until day 42 post-transplant||||Participants|||Count of Participants
2597331|NCT02199028|Secondary|Pain Tolerability of Hyaluronidase Injections|"Patients recorded pain experience at the infusion site (at time of injection and pain each day of wear) in subject diaries on a 0-5 pain scale (0 = no pain and 5 = worst pain imaginable).~The number of diary entries are presented by scale category."|Up to 4 weeks|Only participants in the Hyaluronidase injections group completed diary entries to track pain.|||Diary entries|Diary Entries||Number
2597332|NCT02199028|Secondary|Maximum Glycemic Excursion|The effects of hyaluronidase on post-prandial glucodymamic parameters is presented as the estimated glycemic excursion, a composite value which was calculated based on peak glucose concentration (Cmax), time to Cmax (Tmax), time to early half-maximal glucose concentration (t50%), time to late t50%, and area under the curve (AUC) of glucose concentrations at time intervals of 120 and 240 minutes, with or without hyaluronidase. Estimated glycemic excursion for a patient with Type 1 diabetes that is less than 80 mg/dL is considered acceptable.|Up to 24 hours post infusion||||mg/dL||Standard Deviation|Mean
2597333|NCT02199028|Primary|Duration of Insulin Infusion Set Wear as a Measure of the Effect of Hyaluronidase Treatment|Average (mean) days of wear are presented for each group. A longer period of wear was considered a better outcome.|Up to 4 weeks|Thirty subjects were enrolled in this study; 28 completed all scheduled visits. Therefore, 117 total weeks of infusion set wear were available for analysis including 58 hyaluronidase weeks and 59 standard weeks.|||Days of wear|week of infusion set wear|Standard Deviation|Mean
2597334|NCT02198963|Primary|Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin|"Primary Analysis After a 23-hour ± 1-hour period of exposure, patches were removed, and the sites evaluated and visually scored for irritancy. The procedures will be repeated on the same test sites an additional twenty times. On each day,mean values, sample sizes, ranges, etc., of the irritation scores, for a total of six configurations, were recorded.~Grading Scale for Visual Evaluation of Skin Condition: 0= no evidence of irritation, 1= minimal erythema, barely perceptible, 2= definite erythema, readily visible; minimal edema or minimal papular response, 3= erythema and papules, 4= definite edema, 5= erythema, edema, and papules, 6=' vesicular eruption, 7= strong reaction spreading beyond test site Visual observations of 3, 4, or 5 resulted in discontinuance of product application to that site. Observations of 6 or 7 were considered an adverse event and subject discontinued from the study."|21 days|Each subject had each study material (test, positive and negative controls) applied to separate abraded and non-abraded skin sites|||units on a scale||Standard Deviation|Mean
2597335|NCT02198833|Secondary|Device Specific Adverse Event Assessments|Patient will be assessed daily for signs and symptoms of infection. Catheter placement and patency will be confirmed. Insertion site will be evaluated for signs of inflammation and or trauma.|15 Days|No analysis completed. Study catheter placed in only 2 patients due to inability to clear bacterial from urinary bladder during screening.||||||
2597336|NCT02198833|Secondary|Assess the Microbial Coverage and Biofilm Formation on Catheter Surface|Catheters will be cultured by Roll-plate method for microbial growth. Catheters removed at the Houston site will also be evaluated by scanning electron microscopy to determine microbial coverage and biofilm formation.|Day 15 or upon removal of Foley Catheter|No analysis completed. Study catheter placed in only 2 patients due to inability to clear bacterial from urinary bladder during screening.||||||
2597337|NCT02198833|Secondary|Time to Occurrence of Asymptomatic Bacteruria or Funguria|Urine cultures will be obtained every third day to assess for the presence of microbial growth.|15 days|No analysis completed. Study catheter placed in only 2 patients due to inability to clear bacterial from urinary bladder during screening.||||||
2597338|NCT02198833|Primary|Delay Onset of Catheter Associated Symptomatic Urinary Tract Infection|Patients will be assessed daily for the occurrence of signs and symptoms of urinary tract infection. A single, independent evaluator (PI/co-investigator) will determine whether the subject has a catheter associated urinary tract infection based on pre-defined criteria that involve symptom reports and lab values without knowledge of or access to the catheter type randomly assigned to the patient.|15 Days|No analysis completed due to inability to place study catheter due to persistent bacterial colonization.||||||
2597339|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR)|Erythrocyte sedimentation rate (ESR; mm/hour) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. Negative values indicate improvement from baseline.|From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||mm/hour||Standard Deviation|Mean
2597340|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP)|C-Reactive Protein (CRP; mg/L) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Negative values indicate improvement from baseline.|From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||mg/L||Standard Deviation|Mean
2597341|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale|The FACIT-Fatigue questionnaire is a participant questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions on a scale from 'not at all' (0) to 'very much' (4). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. A negative change from baseline indicates worsening.|At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2597342|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score|The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores for each domain and PCS/MCS range from 0-100: higher scores indicate a better state of health and a decrease from baseline represents worsening.|At Weeks 4, 28, and 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2597343|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score|The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores for each domain and PCS/MCS range from 0-100: higher scores indicate a better state of health and a decrease from baseline represents worsening.|At Weeks 4, 28, and 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2597344|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores|The Work Productivity and Activity Impairment (WPAI) questionnaire for general health is a validated tool in rheumatoid arthritis consisting of 6 questions, based on participant recall of the previous 7 days. WPAI assesses work time missed due to illness (absenteeism), impairment at work due to health (presenteeism), overall work impairment due to health (an aggregate measure of both absenteeism and presenteeism), and total non-occupational activity impairment due to health. WPAI scores are expressed as impairment percentages, with higher scores indicating worse outcomes. A negative change from baseline indicates improvement.|At Weeks 4, 28, and 40 and Flare Weeks 0, 10, and 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||percent impairment||Standard Deviation|Mean
2597345|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score|Participants completed the 14-item Treatment Satisfaction Questionnaire for Medication (TSQM; Version 1.4) to assess satisfaction with their current rheumatoid arthritis treatment over the previous 2-3 weeks or since the last time that they took the medication. The TSQM consists of fourteen items over four domains (effectiveness, side effects, convenience, and global satisfaction). The 14 questions are answered either with yes/no or by means of a five or seven stage scale (ranging from very unsatisfied to satisfied). TSQM Scale scores for each domain range from 0 to 100 and higher scores represent higher satisfaction. Negative values indicate worsening from baseline.|At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2597346|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score|Participants completed the 14-item Treatment Satisfaction Questionnaire for Medication (TSQM; Version 1.4) to assess satisfaction with their current rheumatoid arthritis treatment over the previous 2-3 weeks or since the last time that they took the medication. The TSQM consists of fourteen items over four domains (effectiveness, side effects, convenience, and global satisfaction). The 14 questions are answered either with yes/no or by means of a five or seven stage scale (ranging from very unsatisfied to satisfied). TSQM Scale scores for each domain range from 0 to 100 and higher scores represent higher satisfaction. Negative values indicate worsening from baseline.|At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2597347|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score|Participants completed the 14-item Treatment Satisfaction Questionnaire for Medication (TSQM; Version 1.4) to assess satisfaction with their current rheumatoid arthritis treatment over the previous 2-3 weeks or since the last time that they took the medication. The TSQM consists of fourteen items over four domains (effectiveness, side effects, convenience, and global satisfaction). The 14 questions are answered either with yes/no or by means of a five or seven stage scale (ranging from very unsatisfied to satisfied). TSQM Scale scores for each domain range from 0 to 100 and higher scores represent higher satisfaction. Negative values indicate worsening from baseline.|At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2597348|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score|Participants completed the 14-item Treatment Satisfaction Questionnaire for Medication (TSQM; Version 1.4) to assess satisfaction with their current rheumatoid arthritis treatment over the previous 2-3 weeks or since the last time that they took the medication. The TSQM consists of fourteen items over four domains (effectiveness, side effects, convenience, and global satisfaction). The 14 questions are answered either with yes/no or by means of a five or seven stage scale (ranging from very unsatisfied to satisfied). TSQM Scale scores for each domain range from 0 to 100 and higher scores represent higher satisfaction. Negative values indicate worsening from baseline.|At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2597349|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance|Participants rated the severity of their sleep disturbance in the past week by placing a vertical mark on a line with a range of 0 (sleep is no problem) to 100 mm (sleep is a major problem). Negative values indicate improvement from baseline.|From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2597350|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Morning Stiffness Severity|"Morning stiffness severity was assessed by a numeric rating-scale (NRS). Participants rated the severity of morning stiffness during the past week from 0 to 10 with 0 representing not severe and 10 very severe. Negative values indicate improvement from baseline."|From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2597351|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Morning Stiffness Duration|The duration of morning stiffness was reported by participants as the average daily length during the past week in minutes (from time of awaking to time of maximal improvement). Negative values indicate improvement from baseline.|From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||minutes||Standard Deviation|Mean
2597527|NCT02196714|Primary|Tmax|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (tmax)|Day 1|Pharmacokinetic Population|||h||Full Range|Mean
2597352|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity|Physicians assessed participants' current rheumatoid arthritis disease activity at the time of the visit (independent of the participant's self-assessment) by placing a vertical mark on a line with a range of 0 (very low) to 100 mm (very high). Negative values indicate improvement from baseline.|From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2597353|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain|Participants rated the severity of their rheumatoid arthritis pain in the past week by placing a vertical mark on a line with a range of 0 (no pain) to 100 mm (severe pain). Negative values indicate improvement from baseline.|From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2597354|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity|Participants rated the severity of their rheumatoid arthritis symptoms and how well they were doing during the last 24 hours by placing a vertical mark on a line with a range of 0 (very well) to 100 mm (very poorly). Negative values indicate improvement from baseline.|From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2597355|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Tender Joint Count 68|Sixty-eight joints were assessed for tenderness by physical examination. Pain or tenderness of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with tenderness) to 68 (worst possible score/68 joints with tenderness). Negative values indicate improvement from baseline.|From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||tender joint counts||Standard Deviation|Mean
2597356|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Tender Joint Count 28|Twenty-eight joints were assessed for tenderness by physical examination. Pain or tenderness of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with tenderness) to 28 (worst possible score/28 joints with tenderness). Negative values indicate improvement from baseline.|From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||tender joint counts||Standard Deviation|Mean
2597357|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Swollen Joint Count 66|Sixty-six joints were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with swelling) to 66 (worst possible score/66 joints with swelling). Negative values indicate improvement from baseline.|From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||swollen joint counts||Standard Deviation|Mean
2597358|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Swollen Joint Count 28|Twenty-eight joints, excluding hip joints, were assessed for swelling by physical examination. Swelling of each joint was classified as present (1) or absent (0), for a total possible score of 0 (0 joints with swelling) to 28 (worst possible score/28 joints with swelling). Negative values indicate improvement from baseline.|From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||swollen joint counts||Standard Deviation|Mean
2597359|NCT02198651|Secondary|Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home|The RAPID3 is an activity index derived from the Multi-dimensional Health Assessment Questionnaire (MD-HAQ). It includes an assessment of physical function, a pain Visual Analog Scale (VAS), and a participant global assessment of disease activity VAS. The total RAPID3 score ranges from 0 to 30 where higher scores represent severe disease. Negative values indicate improvement from the Double-blind baseline score.|Flare Week 0 and Flare Weeks 1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15|All Open-label rescue treated participants with available data; last observation carried forward|||units on a scale||Standard Deviation|Mean
2597360|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits|The RAPID3 is an activity index derived from the Multi-dimensional Health Assessment Questionnaire (MD-HAQ). It includes an assessment of physical function, a pain Visual Analog Scale (VAS), and a participant global assessment of disease activity VAS. The total RAPID3 score ranges from 0 to 30 where higher scores represent severe disease. Negative values indicate improvement from the Double-blind baseline score.|From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2597369|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28)|The Disease Activity Score 28 (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR; mm/hour), and the participant's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 (ESR) score. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. Negative values indicate improvement from baseline.|From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2607310|NCT02091752|Secondary|Proportion of Patients Achieving ≥25% and ≥50% Reduction, Respectively From Baseline, in Spleen Length||Week 24|The study was terminated early due to low enrollment. Analysis was not done.||||||
2597361|NCT02198651|Secondary|Number of Participants With Health Assessment Questionnaire- Disability Index (HAQ-DI) Score ≤ 0.5 at Double-blind Baseline and at Week 40|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The number of participants with HAQ-DI score ≤ 0.5 (considered to be normal) was recorded.|Week 4 and Week 40|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||Participants|||Count of Participants
2597362|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22.|From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2597363|NCT02198651|Secondary|Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Erosions Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score|Bone erosions in each bone (wrists: carpal bones, distal radius, distal ulna, metacarpal bases; MCP joints: metacarpal heads, phalangeal bases) were scored separately. The scale is 0-10, based on the proportion of eroded bone compared to the ''assessed bone volume'', judged on all available images—0: no erosion; 1: 1-10% of bone eroded; 2; 11-20%, etc.|From Week 4 to Week 40 or Final Visit|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2597364|NCT02198651|Secondary|Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Marrow Edema (BME) Score|Bone edema in each bone was scored separately. The scale is 0-3 based on the proportion of bone with edema, as follows—0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%.|From Week 4 to Week 40 or Final visit|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2597365|NCT02198651|Secondary|Mean Change From Double-blind Baseline to Week 40 or Final Visit in Magnetic Resonance Imaging (MRI) Synovitis Score|Synovitis was assessed in three wrist regions (the distal radioulnar joint; the radiocarpal joint; the intercarpal and carpometacarpal joints) and in each Metacarpophalangeal joint (MCP) joint. The first carpometacarpal joint and the first MCP joint are not scored. The scale is 0-3. Score 0 is normal, and 1-3 (mild, moderate, severe) are by thirds of the presumed maximum volume of enhancing tissue in the synovial compartment.|From Week 4 to Week 40 or Final visit|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2597366|NCT02198651|Secondary|Number of Participants Maintaining Clinical Remission Defined By DAS28 (ESR) < 2.6, SDAI ≤ 3.3, and CDAI ≤ 2.8 at Each Visit By Treatment Arm|The maintenance of clinical remission after regaining remission during the Open-label rescue period was defined as either Disease Activity Score 28 (DAS28 ESR) < 2.6, Simplified Disease Activity Index (SDAI) score ≤ 3.3, or Clinical Disease Activity Index (CDAI) score ≤ 2.8).|From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period; last observation carried forward|||Participants|||Count of Participants
2597367|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein levels (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86; higher scores indicate more disease activity. Negative values indicate improvement from the Double-blind baseline score.|From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2597368|NCT02198651|Secondary|Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76; higher scores indicate more disease activity. Negative values indicate improvement from the Double-blind baseline score.|From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period and had at least Double-blind Baseline data for this endpoint|||units on a scale||Standard Deviation|Mean
2597422|NCT02197481|Secondary|Mortality|Operative mortality was defined as any death resulting from a complication during surgery|90 days||||participants|||Number
2597423|NCT02197481|Secondary|Liver Transection Time|liver transection time was calculated from the beginning to the end of the liver resection|an expected average of 40 minutes||||min||Standard Deviation|Mean
2597370|NCT02198651|Secondary|Median Time to Clinical Remission From the Occurrence of Flare|The Disease Activity Score 28 (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR; mm/hour), and the participant's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 (ESR) score. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. Clinical remission was defined as DAS28 (ESR) < 2.6. Time to clinical remission was defined as the number of weeks from the occurrence of flare to the first date of clinical remission.|From Flare Week 0 to Flare Week 16|All Open-label rescue treated participants excluding those who incorrectly entered the Open-label Rescue Period|||weeks||95% Confidence Interval|Median
2597371|NCT02198651|Secondary|Number of Participants Who Regained Clinical Remission in the Open-Label Rescue Arm Over Time|The Disease Activity Score 28 (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR; mm/hour), and the participant's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 (ESR) score. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. Clinical remission was defined as DAS28 (ESR) < 2.6.|From Flare Week 0 to Flare Week 16|All Open-label rescue-treated participants excluding those who incorrectly entered the Open-label Rescue Period; last observation carried forward|||Participants|||Count of Participants
2597372|NCT02198651|Secondary|Percentage of Participants With a Flare|Flare was defined as an increase from Double-blind Baseline in DAS (Disease Activity Score) 28 erythrocyte sedimentation rate (ESR) of > 0.6 AND DAS28 [ESR] > 2.6, OR an increase in DAS28 (ESR) of ≥ 1.2 irrespective of the resulting DAS28 [ESR].|From Week 4 to Week 40|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period|||percentage of participants||95% Confidence Interval|Number
2597373|NCT02198651|Secondary|Participants' Assessment of Flare Severity|Participants rated the severity of flare at the Flare Week 0 visit from 0 (not severe) to 10 (very severe). The number of participants within each level of flare severity is presented.|At the Flare Week 0 Visit|All Open-label-rescue-treated participants excluding those who falsely entered the Open-label rescue period|||Participants|||Count of Participants
2597374|NCT02198651|Secondary|Physicians' Assessment of Flare Severity|Physicians rated the severity of flare at the Flare Week 0 visit from 0 (not severe) to 10 (very severe). The number of participants within each level of flare severity is presented.|At the Flare Week 0 Visit|All Open-label-rescue-treated participants excluding those who falsely entered the Open-label rescue period|||Participants|||Count of Participants
2597375|NCT02198651|Secondary|Median Time to Flare|Time to flare was defined as the number of weeks from the date of the first dose of study drug in the Double-blind period to the date of flare.|From Week 4 to Week 40|Double-blind Treated Subject population: participants who received at least 1 dose of study drug during the Double-blind period|||weeks||95% Confidence Interval|Median
2597376|NCT02198651|Primary|Association Between a Composite of Baseline Hand and Wrist Synovitis and Bone Marrow Edema RAMRIS Scores and Flare up to Week 40 in the Tapering Arm|The composite score is the sum of the baseline hand and wrist synovitis and bone marrow edema RAMRIS scores. Flare is defined as an increase from Double-blind Baseline in DAS (Disease Activity Score) 28 erythrocyte sedimentation rate (ESR) of > 0.6 AND DAS28 [ESR] > 2.6, OR an increase in DAS28 (ESR) of ≥ 1.2 irrespective of the resulting DAS28 [ESR]. The association between the composite baseline hand and wrist synovitis score and baseline bone marrow edema rheumatoid arthritis MRI scoring system (RAMRIS) score and occurrence of rheumatoid arthritis flare up to Week 40 in the Tapering arm was examined using logistic regression, and the 95% confidence interval of the odds ratio was calculated.|From Week 4 to Week 40|Participants in the Tapering arm who received at least 1 dose of study drug during the Double-blind period|||odds ratio||95% Confidence Interval|Number
2597377|NCT02198651|Primary|Association Between Baseline Bone Marrow Edema RAMRIS Score and Flare up to Week 40 in the Tapering Arm|Bone marrow edema in each bone was scored separately. The scale is 0-3 based on the proportion of bone with edema, as follows—0: no edema; 1: 1-33% of bone edematous; 2: 34-66% of bone edematous; 3: 67-100%. Flare is defined as an increase from Double-blind Baseline in DAS (Disease Activity Score) 28 erythrocyte sedimentation rate (ESR) of > 0.6 AND DAS28 [ESR] > 2.6, OR an increase in DAS28 (ESR) of ≥ 1.2 irrespective of the resulting DAS28 [ESR]. The association between baseline bone marrow edema rheumatoid arthritis MRI scoring system (RAMRIS) score and occurrence of rheumatoid arthritis flare up to Week 40 in the Tapering arm was examined using logistic regression, and the 95% confidence interval of the odds ratio was calculated.|From Week 4 to Week 40|Participants in the Tapering arm who received at least 1 dose of study drug during the Double-blind period|||odds ratio||95% Confidence Interval|Number
2597378|NCT02198651|Primary|Association Between Baseline Hand and Wrist Synovitis Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score and Flare up to Week 40 in the Tapering Arm|Synovitis was assessed in three wrist regions (the distal radioulnar joint; the radiocarpal joint; the intercarpal and carpometacarpal joints) and in each Metacarpophalangeal joint (MCP) joint. The first carpometacarpal joint and the first MCP joint are not scored. The scale is 0-3. Score 0 is normal, and 1-3 (mild, moderate, severe) are by thirds of the presumed maximum volume of enhancing tissue in the synovial compartment. Flare is defined as an increase from Double-blind Baseline in DAS (Disease Activity Score) 28 erythrocyte sedimentation rate (ESR) of > 0.6 AND DAS28 [ESR] > 2.6, OR an increase in DAS28 (ESR) of ≥ 1.2 irrespective of the resulting DAS28 [ESR]. The association between baseline hand and wrist synovitis RAMRIS score and occurrence of rheumatoid arthritis flare up to Week 40 in the Tapering arm was examined using logistic regression, and the 95% confidence interval of the odds ratio was calculated.|From Week 4 to Week 40|Participants in the Tapering arm who received at least 1 dose of study drug during the Double-blind period|||odds ratio||95% Confidence Interval|Number
2597379|NCT02198430|Secondary|Measure of Weight|Measure of weight|Screening visit (pretreatment assessment)||||Kg||Standard Deviation|Mean
2597380|NCT02198430|Secondary|Assessment of Clinical Patient Variables|Hemophilia type measuring (A or B)|Screening visit||||Percentage of Participants with Hemophil|||Number
2597381|NCT02198430|Primary|Assess the Perception of Quality of Life|Measurement through the Child health profile (Childhood Health and Illness Perception; CHIP-CE).|Screening visit|The score ranges from 0 (poor QoL) to 100 points (good perception of QoL).|||points||Standard Deviation|Mean
2597382|NCT02198430|Primary|Assess the Joint Damage|Measurement with Haemophilia Joint Health Score 2.1 (HJHS)|Screening visit|Haemophilia Joint Health Score assesses joint health in patients with hemophilia. It consists of eight dimensions: swelling, muscular atrophy, crepitation and range of motion, joint pain, strength, motion and axial alignment. The score range is from 0 to 24 points (a score of 0 indicates no joint damage. The higher the score, the higher).|||points||Standard Deviation|Mean
2597383|NCT02198235|Secondary|Median Time to Requiring Oral Opioids|Did patient have pain requiring oral opioids?|24 hours after the popliteal block is given||||hours||95% Confidence Interval|Median
2597384|NCT02198235|Secondary|Numeric Rating Scale (NRS) Pain Score at Rest|Pain at rest at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)|24 hours after the popliteal block is given||||units on a scale||Standard Error|Mean
2597385|NCT02198235|Secondary|Block Duration|When did the nerve block entirely wear off?|24 hours and 48 hours after the popliteal block is given||||hours||95% Confidence Interval|Median
2597386|NCT02198235|Primary|Numeric Rating Scale (NRS) Pain Score With Movement|Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)|24 hours after the popliteal block is given||||units on a scale||Standard Deviation|Mean
2597387|NCT02198040|Secondary|Frequency of Elbow Hemarthrosis|Number of elbow hemarthrosis in the month prior to study|Screening visit (pretreatment assessment)||||bleeding events||Standard Deviation|Mean
2597388|NCT02198040|Secondary|Characteristics of the Patients|Age of patients included in teh study (years)|Screening visit (pretreatment assessment)||||years||Standard Deviation|Mean
2597389|NCT02198040|Primary|Assessment of Radiological Joint Deterioration|Pettersson scale is an additive scale that assesses the radiological joint damage in patients with hemophilic arthropathy. It is scored as a range of 0-13 points (0: no joint damage; 13: maximum joint damage). This scale assesses: osteoporosis, widened epiphyseal, irregularity of the chondral surface, joint space narrowing, subchondral cyst formation, joint margins erosion, joint incongruence and joint deformity (angulation and displacement)|Screening visit (pretreatment assessment)|It has made an analysis by intention to treat with the 27 patients included in the study. It has been estimated the radiological joint damage means (and standard deviation) for elbow joint.|||points||Standard Deviation|Mean
2597390|NCT02198040|Primary|Changes in the Pain Perception of Elbow|Using the visual analogue scale, VAS (subjective rating scale with a score from 0 to 10, where 0 indicates no pain and 10 the maximum pain imaginable by the patient).|Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)||||points||Standard Deviation|Mean
2597391|NCT02198040|Primary|Changes in Biceps Strength|Measured by the breaking test for patients with haemophilia with a score from 0 to 5 (where 0 indicates normal strength and 5 is the absence of muscle contraction).|Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)|It has made an analysis by intention to treat with the 27 patients included in the study|||points||Standard Deviation|Mean
2597392|NCT02198040|Primary|Changes in the Circumference of Arm|Measurement of the arm circumference (in cm) at baseline as a result of hemophilic arthropathy and after treatment and follow-up. The measurement in the upper third of the arm, in the middle of the triceps muscle belly, with a tape measure. We use this outcome to measure circumference of the arm, it is the most clinical measurement used by physiotherapists.|Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)|It has made an analysis by intention to treat with the 27 patients included in the study|||cm||Standard Deviation|Mean
2597393|NCT02198040|Primary|Changes in Range of Motion of Elbow|Measurement the changes of flexion and extension of elbow (in degrees) using a universal goniometer. We were taken as anatomical references, those specified by Querol et al, using the zero-method-reference for the mobile arm goniometer as indicated Norkin et al.|Screening visit (pretreatment assessment), postreatment evaluation (12 week) and follow up assessment (6 months after treatment)|It has made an analysis by intention to treat with the 27 patients included in the study.|||degrees||Standard Deviation|Mean
2597394|NCT02197806|Primary|Percentage of Participants With at Least a 2 Line Improvement From Baseline in Uncorrected Near Visual Acuity (UNVA) in the Non-Dominant Eye|UNVA is assessed without corrective lenses in the non-dominant eye. UNVA is measured using an eye chart and is reported as the number of lines read correctly. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of lines read correctly means that vision has improved. The percentages of patients with at least a 2 or more line improvement in UNVA in the non-dominant eye are presented.|Baseline, Day 3|Modified Intent to Treat: all randomized patients with a baseline assessment and at least 1 postbaseline assessment of UNVA|||Percentage of Patients|||Number
2597395|NCT02197767|Secondary|Change in Proteinuria|Change in proteinuria in milligrams (mg) with the use of rituximab at 12 months.|Day 0, Day 365||||mg||Standard Deviation|Mean
2597396|NCT02197767|Primary|Change in 24 Hour Creatinine Clearance|Change in 24 hour creatinine clearance with the use of rituximab at 12 months. Creatinine clearance results are reported as milliliters/minute/patient's body surface area (mL/min/SA).|Day 0, Day 365||||mL/min/SA||Standard Deviation|Mean
2597397|NCT02197572|Secondary|T1/2: Terminal Elimination Half-life for Sapanisertib||Cycle 1 (28 days cycle), Day 1, predose and at multiple timepoints (Up to 48 hours) postdose|PK analysis population included all participants who received at least 1 dose of sapanisertib and had sufficient concentration-time data to calculate 1 or more PK parameters. Overall number of participants analyzed were participants with data available for analysis of this outcome measure.|||hours||Full Range|Median
2597398|NCT02197572|Secondary|AUCinf: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Sapanisertib||Cycle 1 (28 days cycle), Day 1, predose and at multiple timepoints (Up to 48 hours) postdose|PK analysis population included all participants who received at least 1 dose of sapanisertib and had sufficient concentration-time data to calculate 1 or more PK parameters. Overall number of participants analyzed were participants with data available for analysis of this outcome measure.|||h*ng/mL||Standard Deviation|Mean
2597424|NCT02197481|Primary|The Total Blood Loss|Blood loss during operation. Blood loss was calculated from the beginning to the end of operation The amount of blood loss was measured from the suction volume after subtraction of rinse fluids and from the weight of soaked gauzes that were used during transection|an expected average of 80 minutes||||ml||Standard Deviation|Mean
2597399|NCT02197572|Secondary|AUCt: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of Last Measurable Concentration for Sapanisertib||Cycle 1 (28 days cycle), Day 1, predose and at multiple timepoints (Up to 48 hours) postdose|PK analysis population included all participants who received at least 1 dose of sapanisertib and had sufficient concentration-time data to calculate 1 or more PK parameters. Overall number of participants analyzed were participants with data available for analysis of this outcome measure.|||h*ng/mL||Standard Deviation|Mean
2597400|NCT02197572|Secondary|Tmax: Time to Reach Cmax for Sapanisertib||Cycle 1 (28 days cycle), Day 1, predose and at multiple timepoints (Up to 48 hours) postdose|PK analysis population included all participants who received at least 1 dose of sapanisertib and had sufficient concentration-time data to calculate 1 or more PK parameters.|||hours||Full Range|Median
2597401|NCT02197572|Secondary|Cmax: Maximum Observed Plasma Concentration for Sapanisertib||Cycle 1 (28 days cycle), Day 1, predose and at multiple timepoints (Up to 48 hours) postdose|Pharmacokinetic (PK) analysis population included all participants who received at least 1 dose of sapanisertib and had sufficient concentration-time data to calculate 1 or more PK parameters.|||ng/mL||Standard Deviation|Mean
2597402|NCT02197572|Secondary|Change From Time-Matched Baseline in Heart Rate|Heart rate was assessed using the ECG. Holter monitors were used to collect triplicate ECG measurements and were based on a repeated measure mixed effects linear model. A negative change from baseline indicates decrease in heart rate.|Baseline; Cycle 1 (28 days cycle): 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24 and 48 hours postdose|Primary analysis population: participants that have all timepoints collected on Holter ECG monitoring on Day -1 and Day 1 of Cycle 1 including ECG timepoints on Cycle 1 Days 1 to 3 at 24 or 48 hours postdose and baseline comparisons available for these analyses. Number analyzed is number of participants with evaluable data at given time-point.|||beats per minute (bpm)||Standard Deviation|Mean
2597403|NCT02197572|Secondary|Change From Time-Matched Baseline in PR Interval|PR interval is defined as the time between the start of the P wave and the beginning of the QRS complex on ECG. Holter monitors were used to collect triplicate ECG measurements and were based on a repeated measures mixed effects linear model. A negative change from baseline indicates shortening and a positive change from baseline indicates prolongation of PR interval.|Baseline; Cycle 1 (28 days cycle): 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24 and 48 hours postdose|Primary analysis population: participants that have all timepoints collected on Holter ECG monitoring on Day -1 and Day 1 of Cycle 1 including ECG timepoints on Cycle 1 Days 1 to 3 at 24 or 48 hours postdose and baseline comparisons available for these analyses. Number analyzed is number of participants with evaluable data at given time-point.|||msec||Standard Deviation|Mean
2597404|NCT02197572|Secondary|Change From Time-Matched Baseline in QRS Interval|QRS interval is defined as the time between the start of the Q wave and end of the S wave on ECG. Holter monitors were used to collect triplicate ECG measurements and were based on a repeated measures mixed effects linear model. A negative change from baseline indicates shortening and a positive change from baseline indicates prolongation of QRS interval.|Baseline; Cycle 1 (28 days cycle): 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24 and 48 hours postdose|Primary analysis population: participants that have all timepoints collected on Holter ECG monitoring on Day -1 and Day 1 of Cycle 1 including ECG timepoints on Cycle 1 Days 1 to 3 at 24 or 48 hours postdose and baseline comparisons available for these analyses. Number analyzed is number of participants with evaluable data at given time-point.|||msec||Standard Deviation|Mean
2597405|NCT02197572|Secondary|Mean Change From Time-Matched Baseline in QTc With Rate-Corrected QT Interval Fridericia Correction (QTcF)|The mean changes of QTcF from time-matched baseline was measured by ECG to evaluate the potential effect of drug on QTc interval duration. Holter monitors were used to collect triplicate ECG measurements and were based on a repeated measures mixed effects linear model. A negative change from baseline indicates shortening and a positive change from baseline indicates prolongation of QTcF interval.|Baseline; Cycle 1 (28 days cycle): 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24 and 48 hours postdose|Primary analysis population: participants that have all timepoints collected on Holter ECG monitoring on Day -1 and Day 1 of Cycle 1 including ECG timepoints on Cycle 1 Days 1 to 3 at 24 or 48 hours postdose and baseline comparisons available for these analyses. Number analyzed is number of participants with evaluable data at given time-point.|||msec||Standard Deviation|Mean
2597406|NCT02197572|Secondary|Mean Change From Time-Matched Baseline in QTc With Rate-Corrected QT Interval With Bazett Correction (QTcB)|The mean changes of QTcB from time-matched baseline was measured by ECG to evaluate the potential effect of drug on QTc interval duration. Holter monitors were used to collect triplicate ECG measurements and were based on a repeated measures mixed effects linear model. A negative change from baseline indicates shortening and a positive change from baseline indicates prolongation of QTcB interval.|Baseline; Cycle 1 (28 days cycle): 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24 and 48 hours postdose|Primary analysis population: participants that have all timepoints collected on Holter ECG monitoring on Day -1 and Day 1 of Cycle 1 including ECG timepoints on Cycle 1 Days 1 to 3 at 24 or 48 hours postdose and baseline comparisons available for these analyses. Number analyzed is number of participants with evaluable data at given time-point.|||msec||Standard Deviation|Mean
2597407|NCT02197572|Secondary|Number of Participants With Potentially Clinically Significant Abnormal Vital Signs Reported as AE|Vital sign measurements included blood pressure (diastolic and systolic), heart rate, and temperature. Any abnormal change in the vital sign values were assessed by Investigator and reported as AE. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.|From first dose of study drug through 30 days after the last dose of study drug (Up to 13 months)|Safety population included all participants who received at least 1 dose of sapanisertib.|||Participants|||Count of Participants
2597425|NCT02197455|Secondary|Mean Change in Skindex 16 Scores|Skindex 16 is a quality of life questionaire with a range of 0-100 wherein 1 is not bothered by the condition and 100 is always bothered by the condition|3 months||||units on a scale||Full Range|Mean
2597426|NCT02197455|Primary|Mean Change in Severity of Alopecia Tool (SALT) Score|SALT score range is from 0 (no hair loss) to 100 (100% hair loss)|3 months||||percent change in SALT score||Standard Deviation|Mean
2597408|NCT02197572|Secondary|Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values Reported as AE|The laboratory parameters included clinical chemistry, hematology, and urinalysis. Any abnormal change in the laboratory values were assessed by Investigator and reported as AE. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.|From first dose of study drug through 30 days after the last dose of study drug (Up to 13 months)|Safety population included all participants who received at least 1 dose of sapanisertib.|||Participants|||Count of Participants
2597409|NCT02197572|Secondary|Number of Participants With Atleast One Adverse Event (AE) and Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent.|From first dose of study drug through 30 days after the last dose of study drug (Up to 13 months)|Safety population included all participants who received at least 1 dose of sapanisertib.|||Participants|||Count of Participants
2597410|NCT02197572|Primary|Mean Change From Time-Matched Baseline in QTcI, Individual Baseline Corrected Rate-Corrected QT Interval|The mean changes of QTcI from time-matched baseline was measured by electrocardiogram (ECG) to evaluate the potential effect of drug on QTc interval duration. Holter monitors were used to collect triplicate ECG measurements and were based on a repeated measures mixed effects linear model. A negative change from baseline indicates shortening and a positive change from baseline indicates prolongation of QTcI interval.|Baseline; Cycle 1 (28 days cycle): 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24 and 48 hours postdose|Primary analysis population: participants that have all timepoints collected on Holter ECG monitoring on Day -1 and Day 1 of Cycle 1 including ECG timepoints on Cycle 1 Days 1 to 3 at 24 or 48 hours postdose and baseline comparisons available for these analyses. Number analyzed is number of participants with evaluable data at given time-point.|||msec||Standard Deviation|Mean
2597411|NCT02197520|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) for Insulin Lispro During Clamp||Day 33 during euglycemic 2-step hyperinsulinemic clamp|No participant analyzed because Outcome Measure was incorrectly registered.||||||
2597412|NCT02197520|Secondary|Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29|"VAS was scored from 0 - 100 millimeters (mm) as a perception of appetite and satiety (Flint et al. 2000), 0 being not hungry at all or nothing at all and 100 being extremely hungry and extremely large amount.~The questions are abbreviated in table from: How hungry do you feel right now? to Hunger and How much food do you think you could eat right now? to Food amount. Scores were averaged and will be presented and calculated by a sum of the scores dividing by the total by the number of scores reported for timepoints."|Day 29:Upon waking, pre-breakfast, 1 hour (hr), 2 hr, 3 hr, 4 hr and 5 hr post breakfast|All participants who received at least 1 dose of study drug and had a VAS score.|||millimeters||Standard Deviation|Mean
2597413|NCT02197520|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Acetaminophen||Day 29:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast|All participants who received at least 1 dose of study drug and had evaluable PK data.|||nanograms*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2597414|NCT02197520|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Prandial Insulin Lispro||Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast|All participants who received at least 1 dose of study drug and had evaluable PK parameters.|||picomol*hour per liter||Standard Deviation|Mean
2597415|NCT02197520|Secondary|Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro||Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast|All participants who received at least 1 dose of study drug and had evaluable PD parameters.|||milligram*hour per deciliter||Standard Deviation|Mean
2597416|NCT02197520|Primary|Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value)|During the euglycemic 2-step hyperinsulinemic clamp, both low and high insulin was infused sequentially during the same procedure. The 2-step clamp procedure allowed insulin sensitivity to be measured in participants and uses a lower dose of insulin of which the effect is largely on the liver and a high dose of insulin at which the effect has reached 100% on liver and effects are largely on glucose uptake in peripheral tissues. Measurements for average glucose infusion rate are collected for both steps (low and high) of the clamp procedure.|Day 33, last 30 minutes (final step) of euglycemic 2-step hyperinsulinemic clamp|All participants who received at least 1 dose of study drug and had evaluable PD parameters.|||milligram*hour per deciliter||Standard Deviation|Mean
2597417|NCT02197481|Secondary|Total Bilirubin|serum total bilirubin on 3 postoperative day (umol/L)|3 postoperative day||||umol/l||Standard Deviation|Mean
2597418|NCT02197481|Secondary|Number of Participants Requiring a Blood Transfusion|Administration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively|2 days||||participants|||Number
2597419|NCT02197481|Secondary|Duration of Postoperative Hospital Stay|Time from day of operation to day of discharge|an expected average of 12 days||||days||Standard Deviation|Mean
2597420|NCT02197481|Secondary|Biliary Leakage|Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems|90 days||||participants|||Number
2597421|NCT02197481|Secondary|Morbidity||90 days||||participants|||Number
2597428|NCT02197377|Primary|First Attempt's Success Rate of Insertion|Edentulous elderly patients for the success in first attempt insertion, ease and time of insertion (second).|after anaesthesia induction|Non parametric data between groups were analyzed with the X2-test, while parametric data were compared with unpaired t-test. P < 0.05 was considered significant. 3 LMA insertion failed in Group LMA Supreme. Total 27 patients included analysis.|||percentage of participants|||Number
2597429|NCT02197273|Secondary|Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days||Date of discharge through 30 days following discharge||||participants|||Number
2597430|NCT02197273|Secondary|Time to Post-operative Rescue Opioids (Hours)||Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days||||hours||Full Range|Median
2597431|NCT02197273|Primary|Length of Stay in Hospital (Days)||Participants were followed for the duration of hospital stay, an expected average of 3 days||||days||Full Range|Median
2597432|NCT02197247|Secondary|Assessment of the Metabolic Ratios of AUCtau for AZ5104 and AZ7550 (MRAUCtau)|Assessment of the metabolite to parent ratio (calculated as AZ5104 to AZD9291 and AZ7550 to AZD9291) for AUCtau (MRAUCtau). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2597433|NCT02197247|Secondary|Assessment of the Metabolic Ratios of Css,Max for AZ5104 and AZ7550 (MRCss,Max)|Assessment of the metabolite to parent ratio (calculated as AZ5104 to AZD9291 and AZ7550 to AZD9291) for Css,max (MRCss,max). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2597434|NCT02197247|Secondary|Assessment of CLss/F for Rifampicin|Rate and extent of absorption of rifampicin by assessment of CLss/F. AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.||||L/h||Geometric Coefficient of Variation|Geometric Mean
2597435|NCT02197247|Secondary|Assessment of CLss/F for AZD9291|Rate and extent of absorption of AZD9291 by assessment of the apparent plasma clearance following oral administration and multiple dosing (CLss/F). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.||||Litre per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2597436|NCT02197247|Secondary|Assessment of Css,Min for Rifampicin|Rate and extent of absorption of rifampicin by assessment of minimum plasma concentration at steady state (Css,min). AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2597437|NCT02197247|Secondary|Assessment of Css,Min for AZD9291, and AZ5104 and AZ7550 (Metabolites)|Rate and extent of absorption of AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of minimum plasma concentration at steady state (Css,min). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM||Geometric Coefficient of Variation|Geometric Mean
2597438|NCT02197247|Secondary|Assessment of Tss,Max for Rifampicin|Rate and extent of absorption of rifampicin by assessment of tss,max. AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||h||Full Range|Median
2597439|NCT02197247|Secondary|Assessment of Tss,Max for AZD9291, and AZ5104 and AZ7550 (Metabolites)|Rate and extent of absorption of AZD9291, and AZ5104 and AZ7550 (metabolites) by assessment of time to reach maximum plasma concentration at steady state (tss,max). AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||h||Full Range|Median
2597440|NCT02197247|Secondary|Assessment of AUCtau for Rifampicin|Rate and extent of absorption of rifampicin by assessment of AUCtau. AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2597441|NCT02197247|Secondary|Assessment of AUCtau for AZ7550 (Metabolite)|Rate and extent of absorption of AZ7550 (metabolite) by assessment of AUCtau. AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
2597442|NCT02197247|Secondary|Assessment of AUCtau for AZ5104 (Metabolite)|Rate and extent of absorption of AZ5104 (metabolite) by assessment of AUCtau. AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
2597443|NCT02197247|Secondary|Assessment of AUCtau for AZD9291 Before and After Rifampicin|Rate and extent of absorption of AZD9291 by assessment of AUCtau. AZD9291 alone before rifampicin (Period 1) and AZD9291 alone after rifampicin (Period 3).|Samples collected on Day 28 and 77 following AZD9291 alone at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
2597444|NCT02197247|Secondary|Assessment of Css,Max for Rifampicin|Rate and extent of absorption of rifampicin by assessment of Css,max. AZD9291 dosing in combination with rifampicin (Period 2).|Samples collected on Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nanogram per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2597445|NCT02197247|Secondary|Assessment of Css,Max for AZ7550 (Metabolite)|Rate and extent of absorption of AZ7550 (metabolite) by assessment of Css,max. AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM||Geometric Coefficient of Variation|Geometric Mean
2597446|NCT02197247|Secondary|Assessment of Css,Max for AZ5104 (Metabolite)|Rate and extent of absorption of AZ5104 (metabolite) by assessment of Css,max. AZD9291 dosing alone and in combination with rifampicin (all periods).|Samples collected on Day 28 and 77 (following AZD9291 alone) and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM||Geometric Coefficient of Variation|Geometric Mean
2597447|NCT02197247|Secondary|Assessment of Css,Max for AZD9291 Before and After Rifampicin|Rate and extent of absorption of AZD9291 by assessment of Css,max. AZD9291 alone before rifampicin (Period 1) and AZD9291 alone after rifampicin (Period 3).|Samples collected on Day 28 and 77 following AZD9291 alone at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM||Geometric Coefficient of Variation|Geometric Mean
2597448|NCT02197247|Primary|Assessment of Area Under the Plasma Concentration-time Curve During the Dosing Interval for AZD9291 After Dosing Alone and in Combination With Rifampicin (AUCtau)|Rate and extent of absorption of AZD9291 by assessment of AUCtau. AZD9291 doses were first without, then with rifampicin (Periods 1 and 2, respectively).|Samples collected on Day 28 following AZD9291 alone and Day 49 following AZD9291 and rifampicin at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nM * hour (nM*h)||Geometric Coefficient of Variation|Geometric Mean
2597449|NCT02197247|Primary|Assessment of Maximum Plasma Concentration for AZD9291 After Dosing Alone and in Combination With Rifampicin (Css,Max)|Rate and extent of absorption of AZD9291 by assessment of maximum plasma concentration at steady state (Css,max). AZD9291 doses were first without, then with rifampicin (Periods 1 and 2, respectively).|Samples collected on Day 28 following AZD9291 alone and Day 49 (following AZD9291 and rifampicin) at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose in Part A.|The PK analysis set included all dosed patients who had at least 1 quantifiable plasma concentration collected post-dose without any important deviations or events that would exclude the patient.|||nanomolar (nM)||Geometric Coefficient of Variation|Geometric Mean
2597450|NCT02197234|Secondary|AUC(0-t) of Simvastatin and Simvastatin Acid|Pharmacokinetics of simvastatin and simvastatin acid by assessment of area under the plasma concentration time curve from time zero to last quantifiable dose|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.|||ng.h/mL||Full Range|Geometric Mean
2597451|NCT02197234|Secondary|AUC of Simvastatin Acid|Pharmacokinetics of simvastatin acid by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.|||ng.h/mL||Full Range|Geometric Mean
2597452|NCT02197234|Secondary|Cmax of Simvastatin Acid|Pharmacokinetics of simvastatin acid by assessment of maximum plasma simvastatin acid concentration|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.|||ng/mL||Full Range|Geometric Mean
2597518|NCT02196714|Primary|Lambda z|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||1/h||Full Range|Mean
2597519|NCT02196714|Primary|Lambda z|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||1/h||Full Range|Mean
2597453|NCT02197234|Secondary|CL/F of Simvastatin|Rate and extent of absorption of simvastatin by assessment of apparent clearance following oral administration|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.|||L/h||Full Range|Geometric Mean
2597454|NCT02197234|Secondary|Tmax of Simvastatin and Simvastatin Acid|Pharmacokinetics of simvastatin and simvastatin acid by time to Cmax|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.|||hours||Full Range|Median
2597455|NCT02197234|Primary|AUC of Simvastatin|Pharmacokinetics of simvastatin by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.|||ng.h/mL||Full Range|Geometric Mean
2597456|NCT02197234|Primary|Cmax of Simvastatin|Pharmacokinetics of simvastatin by assessment of maximum plasma simvastatin concentration|Blood samples collected on Days 1 and 31 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 28, and 32 hours post simvastatin dose in Part A|Pharmacokinetic population - all patients who received at least 1 dose of simvastatin or AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations.|||ng/mL||Full Range|Geometric Mean
2597457|NCT02197130|Secondary|Clinical Global Impression of Improvement (CGI-I) Scale Score After 13 and 26 Weeks of Treatment.|"CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: Compared to your subject's condition at the beginning of treatment, how much has your subject changed?. Improvement was compared to baseline and was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. n is the number of evaluable participants in each visit."|Week 13 & Week 26|All participants who have been randomized and have taken at least one dose of PF-02545920 or placebo. Participants without post-dose measurements will not contribute to the analysis, except in the description of the baseline values.|||units on a scale||Standard Deviation|Mean
2597458|NCT02197130|Secondary|Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) From Baseline to Follow-up Visit|The C-SSRS captured the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt; preparatory acts towards imminent suicidal behavior; suicidal ideation; self-injurious behavior, no suicidal intent. The results presented are the number of participants with completed suicide or non-fatal suicide events or behaviors. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.|Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)|All participants with at least one dose of study medication.n is the number of evaluable participants in each visit|||participants|||Number
2597459|NCT02197130|Secondary|Change From Baseline in the Total Maximum Chorea (TMC) Score of the UHDRS After 13 and 26 Weeks of Treatment.|The UHDRS was a clinical rating scale which has been developed by the Huntington Disease Study Group (HSG) to provide a uniform assessment of the clinical features and course of HD. The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. The Total Maximum Chorea (TMC) was a subset of the TMS assessment. It was composed of the scoring of 7 chorea assessments (face, orobuccolingual, trunk, right and left upper extremities, right and left lower extremities). Each assessment was rated from 0 to 4 (absent to prolonged). TMC is obtained by adding up each of the separate scores, leading to max score of 28. The minimum score is 0. The higher the score, the worse the symptoms. n is the number of evaluable subjects in each visit.|Baseline, Week 13, Week 26|All participants who have been randomized and have taken at least one dose of PF-02545920 or placebo. Participants without post-dose measurements did not contribute to the analysis, except in the description of the baseline values.|||units on a scale||Standard Deviation|Mean
2597460|NCT02197130|Secondary|Severity of Adverse Events Related to Extrapyramidal Symptoms (EPS) Including Dystonia and Akathisia|Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event). EPS were reported AEs of dystonia and akathisia.|Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)|All participants with at least one dose of study medication.|||participants|||Number
2597461|NCT02197130|Secondary|Number of Participants With Electrocardiogram (ECG) Data That Met Criteria for Potential Clinical Concern(Increase From Baseline)|Number of participants with ECG meeting the following criteria was reported: Criterion A: maximum PR interval increase from baseline percentage change (PctChg)>= 25/50%; Criterion B: maximum QRS complex increase from baseline PctChg >=50%; Criterion C: maximum QTcF interval (Fridericia's correction) increase from baseline 30<=change<60 msec; Criterion D: maximum QTcF interval (Fridericia's correction) increase from baseline change >=60 msec.|Screening, Day 1, 28, 91, and 182|All participants with at least one dose of study medication.|||participants|||Number
2597487|NCT02196857|Primary|Participants With a Response CR + PR + CRi|Criteria for response per the International Working Group for myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Complete Response (CR) was defined as </= 5% blasts in the bone marrow (BM) with peripheral blood (PB) demonstrating greater thatn 1x10^9/L platelets with no detectable extramedullary disease. CR with incomplete recovery of PB counts (CRi) is the above criteria but neutrophil or platelet counts less than the stated values. Partial Response (PR) required all of the hematologic values for a CR but with a reduction of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate.|After 3, 28 day cycles||||Participants|||Count of Participants
2597462|NCT02197130|Secondary|Number of Participants With Electrocardiogram (ECG) Data That Met Criteria for Potential Clinical Concern(Absolute Values)|The number of participants with ECG absolute values meeting the following criteria was reported: Criterion A: maximum PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization) >=300 msec; Criterion B: maximum QRS complex(time from Q wave to the end of S wave, corresponding to ventricle depolarization) >=140 msec; Criterion C: maximum QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia's formula) 450-<480 msec; Criterion D: maximum QTcF interval 480-<500 msec; Criterion E: maximum QTcF interval (Fridericia's correction) >=500 msec|Screening, Day 1, 28, 91, and 182|All participants with at least one dose of study medication.|||participants|||Number
2597463|NCT02197130|Secondary|Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Decrease From Baseline)|The number of participants with vital signs data of maximum decrease from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in supine SBP >= 30 mmHg; Criterion B: maximum decrease from baseline in standing SBP >= 30 mmHg; Criterion C: maximum decrease from baseline in supine DBP >=20 mmHg; Criterion D: maximum decrease from baseline in standing DBP >=20 mmHg|Screening, Day 1, 28, 91, and 182|All participants with at least one dose of study medication.|||participants|||Number
2597464|NCT02197130|Secondary|Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Increase From Baseline)|The number of participants with vital signs data of maximum increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in supine SBP greater than or equal to (>=) 30 mmHg; Criterion B: maximum increase from baseline in standing SBP >= 30 mmHg; Criterion C: maximum increase from baseline in supine DBP >=20 mmHg; Criterion D: maximum increase from baseline in standing DBP >=20 mmHg|Screening, Day 1, 28, 91, and 182|All participants with at least one dose of study medication.|||participants|||Number
2597465|NCT02197130|Secondary|Number of Participants With Vital Sign Data That Met Criteria for Potential Clinical Concern (Absolute Values)|Absolute values were analyzed for supine systolic blood pressure (SBP), standing SBP, supine diastolic blood pressure (DBP), standing DBP, supine pulse rate, and standing pulse rate. Number of participants with vital signs data meeting the following criteria was reported: Criterion A: supine SBP less than (<) 90 millimeter of mercury(mmHg); Criterion B: standing SBP < 90 mmHg; Criterion C: supine DBP <50 mmHg; Criterion D: standing DBP <50 mmHg; Criterion E: supine pulse rate < 40 beats per minute(BPM); Criterion F: supine pulse rate greater than (>)120 BPM; Criterion G: standing pulse rate < 40 beats per minute(BPM); Criterion H: standing pulse rate >120 BPM;|Screening, Day 1, 28, 91, and 182|All participants with at least one dose of study medication.|||participants|||Number
2597466|NCT02197130|Secondary|Number of Participants With Laboratory Test Abnormalities (With Normal Baseline)|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes);coagulation (PT international ratio); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma GT, LDH, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (calcium, sodium, potassium, chloride, total bicarbonate, magnesium, phosphate); clinical chemistry (glucose, glycosylated, hemoglobin, human chorionic gonadotropin, creatine kinase); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], urine specific gravity, glucose, protein, blood, ketones, nitrite).|Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)|All participants with at least one dose of study medication.|||participants|||Number
2597467|NCT02197130|Secondary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormalities)|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes);coagulation (PT international ratio); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma GT, LDH, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (calcium, sodium, potassium, chloride, total bicarbonate, magnesium, phosphate); clinical chemistry (glucose, glycosylated, hemoglobin, human chorionic gonadotropin, creatine kinase); urinalysis (decimal logarithm of reciprocal of hydrogen ion activity [pH], urine specific gravity, glucose, protein, blood, ketones, nitrite).|Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)|All participants with at least one dose of study medication.|||participants|||Number
2597468|NCT02197130|Secondary|Number of Participants With Serious Adverse Events|Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.|Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)|All participants with at least one dose of study medication.|||participants|||Number
2597469|NCT02197130|Secondary|Number of Participants With Adverse Events|Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)|All participants with at least one dose of study medication.|||participants|||Number
2597470|NCT02197130|Secondary|Number of Participants That Met White Blood Count (WBC) and Absolute Neutrophil Count (ANC) Stopping Criteria|The criteria for temporary study suspension was as follow: Criterion A: WBC count <=3000 cells/mm3 but >= 2000 cells/mm3 or ANC <= 1500 cells/mm3 but >= 1000 cells/mm3; Criterion B: WBC <= 2000 cells/mm3 or ANC <= 1000 cells/mm3; Criterion C: participants who are discontinued or permanently suspended due to WBC or ANC findings; Criterion D: ANC <= 500 cells/mm3|Screening, Day 1, 7, 14, 28, 56, 91, 133, 182 and follow-up visits (from Day 189 to 192)|All participants with at least one dose of study medication.|||participants|||Number
2597488|NCT02196831|Secondary|Change in Aspartate Aminotransferase (AST)|change (value at 12 months minus value at baseline)|change from baseline to 12 months|all participants with available data at both baseline and 12 month visits|||units/liter (U/L)||Standard Deviation|Mean
2597471|NCT02197130|Primary|Change From Baseline in the Total Motor Score (TMS) Assessment of the Unified Huntington Disease Rating Scale (UHDRS) After 26 Weeks of Treatment.|The UHDRS was a clinical rating scale which has been developed by the Huntington Disease Study Group (HSG) to provide a uniform assessment of the clinical features and course of Huntington's Disease (HD). The components of the full UHDRS assess motor function, cognition, behavior and functional abilities. The total motor score (TMS) assessed motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. Some items (such as chorea and dystonia) required grading each extremity (face, bucco-oral-lingual, and trunk) separately. Eye movements require both horizontal and vertical grades. The total motor impairment scores was the sum of all the individual 31 motor sub-items (each rated from 0 to 4), with higher scores indicating more severe motor impairment than lower scores. The range of TMS is 0-124.|Baseline, Week 26|All participants who have been randomized and have taken at least one dose of PF-02545920 or placebo. Participants without post-dose measurements did not contribute to the analysis, except in the description of the baseline values.|||units on a scale||Standard Deviation|Mean
2597472|NCT02197078|Secondary|Number of Participants With Acute Renal Failure Requiring Dialysis|Number of patients with acute renal failure requiring dialysis|Up to 5 years and 7 months|1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.|||Participants|||Number
2597473|NCT02197078|Secondary|Number of Participants With Acute Renal Failure|Number of participants with acute renal failure|Up to 5 years and 7 months|1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.|||Participants|||Number
2597474|NCT02197078|Secondary|Number of Participants With Incident End Stage Renal Disease|Number of participants with incident end stage renal disease (ESRD)|Up to 5 years and 7 months|1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016. For this outcome only, patients with ESRD at any time prior to and including the day of treatment initiation were excluded.|||Participants|||Number
2597475|NCT02197078|Secondary|Number of Participants With Heart Failure Hospitalization|Number of participants with heart failure hospitalization|Up to 5 years and 7 months|1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.|||Participants|||Number
2597476|NCT02197078|Primary|Number of Participants With Stroke|Number of participants with ischemic or hemorrhagic stroke. Both types of stroke were included in the definition for stroke, but were not assessed separately|Up to 5 years and 7 months|1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.|||Participants|||Number
2597477|NCT02197078|Primary|Number of Participants With Acute Coronary Syndrome|Number of participants with acute coronary syndrome (ACS). The definition for ACS included acute myocardial infarction (MI), but acute MI was not assessed separately.|Up to 5 years and 7 months|1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.|||Participants|||Number
2597478|NCT02197078|Primary|Number of Participants With Coronary Revascularization|Number of participants with coronary revascularization (elective and non-elective procedure)|Up to 5 years and 7 month|1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016.|||Participants|||Number
2597479|NCT02197078|Primary|Number of Participants With Major Adverse Cardiovascular Event|"Number of participants with major adverse cardiovascular event is presented by the number of patients reported a composite of:~Coronary revascularization (elective and non-elective procedure)~Acute coronary syndrome (ACS), including acute myocardial infarction (MI)~Stroke (Ischemic and hemorrhagic stroke)"|Up to 5 years and 7 months|1:1 propensity score matched cohorts of linagliptin initiators and comparator groups initiators, identified from Clinformatics and MarketScan database between May 2011 and December 2016|||Participants|||Number
2597480|NCT02197065|Secondary|Peri-operative Rise in Interleukin-6 (IL-6) Levels|The change in the level of IL-6 from baseline to POD2 in 16 arthroplasty patients randomized (1:1) to atorvastatin 40mg versus placebo.|Change from preoperative to postoperative day 2|16 arthroplasty patients|||pg/mL||Inter-Quartile Range|Median
2597481|NCT02197065|Primary|Peri-operative Rise in High Sensitivity C-reactive Protein (Hs-CRP)|The change in the level of hs-CRP from baseline to POD2 in 20 orthopedic patients randomized (1:1) to atorvastatin 40mg versus placebo.|Change from preoperative to post-operative day 2||||mg/L||Inter-Quartile Range|Median
2597482|NCT02197065|Primary|Percentage of All Enrolled Patients With a Peri-operative Rise in High-sensitivity Cardiac Troponin I|The percentage of orthopedic patients with a ≥ 10 pg/mL rise in high-sensitivity cardiac troponin I (hs-cTnI) from baseline pre-operatively to post-operative day (POD)2|change from preoperative to postoperative day 2|20 orthopedic surgery patients.|||percentage of patients|||Number
2597483|NCT02196922|Secondary|Quality of Life|Minnesota Quality of Life Questionnaire is a validated instrument specifically designed to measure quality of life for heart failure patients. Possible scores range from 0 (best quality of life) to 105 (worst quality of life)|Baseline and Day 90||||units on a scale||Full Range|Mean
2597484|NCT02196922|Primary|Emergency Department Visits|Emergency Department Visits, defined as Mean Number of visits over the 90 day observation period|Days 0-90|Intention to Treat population (all participants to COM or TSM)|||participants group mean ED visits/90 day||Standard Deviation|Mean
2597485|NCT02196922|Primary|Hospitalizations|Number of hospitalizations during the 90 day observation period|Baseline and Day 90|Intention to treat population (all participants who are randomized to either COM or TSM.|||participant mean hospitalizations/90 day||Standard Deviation|Mean
2597486|NCT02196857|Secondary|Toxicity Profile of Azacytidine and Sorafenib|Severity of toxicities graded according to the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0. Standard reporting guidelines followed for adverse events. Safety data summarized by category, severity and frequency.|After 3, 28 day cycles||||Participants|||Count of Participants
2597490|NCT02196831|Secondary|Change in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score|"change (value at 12 months minus value at baseline). The nonalcoholic fatty liver disease (NAFLD) activity score is a standardized histological quantification of NAFLD severity designed and validated by the Nonalcoholic Steatohepatitis Clinical Research Network (Kleiner DE et al., Hepatology, 2005, 41(6):1313-1321). The score is the sum of three semi-quantitative histological grades:~steatosis, graded from 0 [<5% liver fat] to grade 3 [>66% liver fat]~lobular inflammation, graded from 0 [no foci of inflammation] to 3 [>4 foci per 200x field]~hepatocellular ballooning, graded from 0 [no ballooning] to 2 [many cells/prominent ballooning] The total NAFLD activity score, a sum of the three components below, ranges from 0 to 8, with a higher score generally representing greater severity of NAFLD/nonalcoholic steatohepatitis."|change between baseline and 12 months|all participants with available biopsy data from both baseline and 12 month visits|||score on a scale, NAFLD activity score||Standard Deviation|Mean
2597491|NCT02196831|Primary|Change in Liver Fat as Measured by 1-H Magnetic Resonance Spectroscopy|change (value at 12 months minus value at baseline). Hepatic fat fraction is a standardized measure used to describe the percent fat in the liver. As it is determined by spectroscopy, it is quantified by the area under the lipid peak, standardized to the total area under the (lipid peak + water peak). Using 1-H Magnetic resonance spectroscopy to quantify liver fat in this manner was first described by Longo R et al., Invest Radiol, 1993, 28(4):297-302.|change between baseline and 12 months|These are participants who had magnetic resonance spectroscopy for hepatic fat fraction at 0 and 12 months. This is different from the primary analysis population reported in the manuscript.|||percent (hepatic fat fraction)||Standard Deviation|Mean
2597492|NCT02196766|Primary|Ocular Health - Papillary Conjunctivitis|Papillary conjunctivitis for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).|1 week||||Eyes|Participants||Number
2597493|NCT02196766|Primary|Ocular Health - Limbal Redness|Limbal redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).|1 week||||Eyes|Participants||Number
2597494|NCT02196766|Primary|Ocular Health - Conjunctival Redness|Conjunctival redness for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).|1 week||||Eyes|Participants||Number
2597495|NCT02196766|Secondary|Burning Sensation Right After Insertion (Subjective Rating)|Subjective rating of burning sensation right after insertion for each combination assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).|Baseline||||units on a scale||Standard Deviation|Mean
2597496|NCT02196766|Secondary|Stinging Sensation Right After Insertion (Subjective Rating)|Subjective rating of stinging sensation for the combinations is assessed at baseline. (Scale 0-10; 0=difficult to wear, 10=no sensation at all).|Baseline||||units on a scale||Standard Deviation|Mean
2597497|NCT02196766|Primary|Ocular Health - Corneal Staining|Corneal staining for each combination was assessed by slit lamp at 1 week. (Grade 0-4; 0=normal, 1=trace, 2=mild, 3=moderate, 4= severe).|1 week||||Eyes|Participants||Number
2597498|NCT02196714|Secondary|Change in QTc Fridericia's Interval From Pre-dose to 12 Hours Post Dose|Change in QTc Fridericia's Interval from Pre-dose to 12 hours Post dose|12 hours|Safety Population|||msec||Full Range|Mean
2597499|NCT02196714|Secondary|Change in QTc Bazett Interval From Pre-dose to 12 Hours Post Dose|Change in QTc Bazett Interval from Pre-dose to 12 hours Post dose|12 hours|Safety Population|||msec||Full Range|Mean
2597500|NCT02196714|Secondary|Change in QT Interval From Pre-dose to 12 Hours Post Dose|Change in QT Interval from Pre-dose to 12 hours Post dose|12 hours|Safety Population|||msec||Full Range|Mean
2597501|NCT02196714|Secondary|Change in QRS Duration From Pre-dose to 12 Hours Post Dose|Change in QRS duration from Pre-dose to 12 hours Post dose|12 hours|Safety Population|||msec||Full Range|Mean
2597502|NCT02196714|Secondary|Change in QRS Axis From Pre-dose to 12 Hours Post Dose|Change in QRS axis from Pre-dose to 12 hours Post dose|12 hours|Safety Population|||QRS axis||Full Range|Mean
2597503|NCT02196714|Secondary|Change in PR Interval From Pre-dose to 12 Hours Post Dose|Change in PR Interval from Pre-dose to 12 hours Post dose|12 hours|Safety Population|||msec||Full Range|Mean
2597504|NCT02196714|Secondary|Change in Heart Rate From Pre-dose to 12 Hours Post Dose|Change in Heart Rate from Pre-dose to 12 hours Post dose|12 hours|Safety Population|||Beats/Min||Full Range|Mean
2597505|NCT02196714|Secondary|Change in Mean Glucose and Potassium Results (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Glucose and Potassium Results (±SD) from Pre-dose to 12 Hours Post-dose|12 hours|Safety Population|||mmol/L||Full Range|Mean
2597506|NCT02196714|Secondary|Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ferritin)|12 hours|Safety Population|||μg/L||Standard Deviation|Mean
2597507|NCT02196714|Secondary|Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose (eGFR)|12 hours|Safety Population|||mL/min/1.73m2||Standard Deviation|Mean
2597508|NCT02196714|Secondary|Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 hours|Safety Population|||μmol/L||Standard Deviation|Mean
2597509|NCT02196714|Secondary|Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 hours|Safety Population|||mmol/L||Standard Deviation|Mean
2597510|NCT02196714|Secondary|Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 hours|Safety Population|||g/L||Standard Deviation|Mean
2597511|NCT02196714|Secondary|Change in Mean Chemistry Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Chemistry Parameters (±SD) from Pre-dose to 12 Hours Post-dose|12 hours|Safety Population|||IU/L||Standard Deviation|Mean
2597512|NCT02196714|Secondary|Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Erythrocytes)|12 Hours|Safety Population|||10^12cells/L||Standard Deviation|Mean
2597513|NCT02196714|Secondary|Change in Mean Hematology Parameters (±SD) From Pre-dose to 12 Hours Post-dose|Change in Mean Hematology Parameters (±SD) from Pre-dose to 12 Hours Post-dose (Ery. mean corpuscuar hemoglobin)|12 Hours|Safety Population|||pg/cell||Standard Deviation|Mean
2597528|NCT02196714|Primary|AUC 0-∞|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-∞)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||h*pg/mL||Full Range|Mean
2597529|NCT02196714|Primary|AUC 0-∞|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-∞)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||h*pg/mL||Full Range|Mean
2597530|NCT02196714|Primary|AUC 0-t|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-t)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||h*pg/mL||Full Range|Mean
2597531|NCT02196714|Primary|AUC 0-t|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-t)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||h*pg/mL||Full Range|Mean
2597532|NCT02196714|Primary|AUC 0-12|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (AUC 0-12)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||h*pg/mL||Full Range|Mean
2597533|NCT02196714|Primary|AUC 0-12|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (AUC 0-12)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||h*pg/mL||Full Range|Mean
2597534|NCT02196714|Primary|Cmax|Descriptive Statistics for Pharmacokinetic Parameters of Formoterol by Treatment (Cmax)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||pg/mL||Full Range|Mean
2597535|NCT02196714|Primary|Cmax|Descriptive Statistics for Pharmacokinetic Parameters of Glycopyrronium by Treatment (Cmax)|Day 1|Pharmacokinetic Population (includes subjects with an evaluable profile for this analyte)|||pg/mL||Full Range|Mean
2597536|NCT02196701|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 24||Baseline and week 24|Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.|||mg/L||Standard Error|Least Squares Mean
2597537|NCT02196701|Secondary|Percentage of Participants Who Achieved a DLQI Score of 0 or 1 Over Time|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.|Baseline and Weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
2597538|NCT02196701|Secondary|Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.|Baseline, weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.|||percent change||Standard Error|Least Squares Mean
2597539|NCT02196701|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. A negative change from Baseline indicates improvement.|Baseline, weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.|||units on a scale||Standard Error|Least Squares Mean
2597540|NCT02196701|Secondary|Percent Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis|"The total body surface area affected by psoriasis (expressed as a percentage) was measured by the investigator using the palm method, where the participant's hand represents 1% of body surface area.~A decrease in BSA affected by psoriasis indicates improvement."|Baseline and weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.|||percent change||Standard Error|Least Squares Mean
2597541|NCT02196701|Secondary|Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis|"The total body surface area affected by psoriasis (expressed as a percentage) was measured by the investigator using the palm method, where the participant's hand represents 1% of body surface area.~A decrease in BSA affected by psoriasis indicates improvement."|Baseline and weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.|||percentage of body surface area||Standard Error|Least Squares Mean
2597542|NCT02196701|Secondary|Percentage of Participants Achieving a Physician's Global Assessment of Disease Activity (PGA) of Cleared or Minimal Over Time|"The PGA is a 6-point scale used to measure the severity of disease at the time of the evaluation. The degree of overall lesion severity was evaluated using the following categories:~0 (Cleared): No evidence of scaling, erythema, or plaque elevation;~1 (Minimal): Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation;~2 (Mild): Fine scale dominates, light red coloration, mild plaque elevation;~3 (Moderate): Course scale dominates, moderate red coloration, moderate plaque elevation;~4 (Marked): Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation;~5 (Severe): Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation.~The percentage of participants achieving a score of clear (0) or minimal (1) is reported."|Weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
2597543|NCT02196701|Secondary|Percent Change From Baseline in PASI Score|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).|Baseline and weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.|||percent change||Standard Error|Least Squares Mean
2597544|NCT02196701|Secondary|Change From Baseline in PASI Score Over Time|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).|Baseline and weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. A mixed-effect model repeat measurement was used.|||units on a scale||Standard Error|Least Squares Mean
2597545|NCT02196701|Secondary|Percentage of Participants Who Achieved a PASI 100 Response Over Time|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 100 response is defined as a 100% reduction (improvement) from baseline in PASI score.|Baseline and Weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
2597546|NCT02196701|Secondary|Percentage of Participants Who Achieved a PASI 90 Response Over Time|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 90 response is defined as at least a 90% reduction (improvement) from baseline in PASI score.|Baseline and Weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
2597547|NCT02196701|Secondary|Percentage of Participants Who Achieved a PASI 75 Response Over Time|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 75 response is defined as at least a 75% reduction (improvement) from baseline in PASI score.|Baseline and Weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
2597548|NCT02196701|Secondary|Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI) 50 Response Over Time|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 50 response is defined as at least a 50% reduction (improvement) from baseline in PASI score.|Baseline and Weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
2597549|NCT02196701|Secondary|Number of Participants Achieving Each Satisfactory Category Based on Patient Self-assessment Over Time|"Participants were asked to complete the following questionnaire at each scheduled visit:~Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:~Completely dissatisfied~Moderately dissatisfied~Slightly satisfied~Highly satisfied~Completely satisfied"|Baseline, weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX and with available data at each time point..|||Participants|||Count of Participants
2597550|NCT02196701|Secondary|Number of Participants Achieving Each Satisfactory Category Based on Investigator Assessment Over Time|"Study investigators were asked to complete the following questionnaire at each scheduled visit:~Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:~Completely dissatisfied~Moderately dissatisfied~Slightly satisfied~Highly satisfied~Completely satisfied"|Baseline, weeks 8, 16, and 24|Participants who received at least one dose of ADA and one dose of MTX with available data at each time point.|||Participants|||Count of Participants
2597551|NCT02196701|Secondary|Percentage of Participants Achieving a Satisfactory Response Based on Patient Self-assessment Over Time|"Participants were asked to complete the following questionnaire at each scheduled visit:~Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:~Completely dissatisfied~Moderately dissatisfied~Slightly satisfied~Highly satisfied~Completely satisfied~Satisfaction with therapy was defined by the combination of highly or completely satisfied responses."|Baseline, week 8 and week 24|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
2597552|NCT02196701|Secondary|Percentage of Participants Achieving a Satisfactory Response Based on Investigator Assessment Over Time|"Study investigators were asked to complete the following questionnaire at each scheduled visit:~Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:~Completely dissatisfied~Moderately dissatisfied~Slightly satisfied~Highly satisfied~Completely satisfied~Satisfaction with therapy was defined by the combination of highly or completely satisfied responses."|Baseline, week 8 and week 24|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
2597574|NCT02196168|Secondary|Incidence of Adverse Events Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Gr 3, Gr 4 and Gr 5 AEs at least possibly related to study drug|Up to 1 year||||adverse events|||Number
2597553|NCT02196701|Primary|Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Patient Self-assessment|"Participants were asked to complete the following questionnaire at week 16:~Overall, at this point in time, how satisfied are you with your current treatment for psoriasis? The response choices provided were:~Completely dissatisfied~Moderately dissatisfied~Slightly satisfied~Highly satisfied~Completely satisfied~Satisfaction with therapy was defined by the combination of highly or completely satisfied responses."|Week 16|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values at week 16 were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
2597554|NCT02196701|Primary|Percentage of Participants Achieving a Satisfactory Response at Week 16 Based on Investigator Assessment|"Study investigators were asked to complete the following questionnaire at week 16:~Overall, at this point in time, how satisfied are you with the psoriasis control provided by the subject's current treatment regimen? The response choices provided were:~Completely dissatisfied~Moderately dissatisfied~Slightly satisfied~Highly satisfied~Completely satisfied~Satisfaction with therapy was defined by the combination of highly or completely satisfied responses."|Week 16|Participants who received at least one dose of ADA and one dose of MTX. Participants with missing values at week 16 were categorized as non-responders.|||percentage of participants||95% Confidence Interval|Number
2597555|NCT02196688|Secondary|Over Survival (OS)|The OS refers to the time interval between the randomization date and the date of death (any cause). The final known date of survival will be used as the censoring date for subjects that have not been reported to have died by the time of analysis.|From randomization until death due to any cause.||||months||95% Confidence Interval|Median
2597556|NCT02196688|Secondary|Disease Control Rate (DCR)|The DCR is defined as the rate of corroborant CR, PR and stable disease (SD) as the BOR, based on evaluation of target lesions and non-target lesions with corroborant radiological method and determined according to RECIST v1.1, for the ITT set of response evaluable subjects.|From randomization up to progressive disease or EOT due to any cause.||||Participants|||Count of Participants
2597557|NCT02196688|Secondary|Objective Response Rate (ORR)|The ORR is defined as the rate of complete response (CR) or partial response (PR) as the best overall response (BOR), based on evaluation of target lesions and non-target lesions with corroborant radiological method and determined by RECIST v1.1, for the ITT set of response evaluable subjects. Subjects who have no post-baseline tumor evaluation shall be regarded as subjects without ORR. Subjects who qualify for evaluation of CR or PR should have at least one available lesion for measurement with RECIST v1.1.|From randomization up to progressive disease or end of treatment (EOT) due to any cause.||||Participants|||Count of Participants
2597558|NCT02196688|Primary|Progression Free Survival (PFS)|PFS refers to the time interval between the randomization date and the initial record of PD or date of death, whichever is earlier. The presence of PD shall be determined in accordance with the result of the evaluation performed by the investigator, using with RECIST v1.1 criteria. The date of final tumor evaluation will be used as the censoring date for subjects who have not presented with disease progression or death by that date. The date of randomization will be used as the censoring date for subjects which have no death and post-baseline tumor evaluation. If a subject has no post-baseline tumor evaluation but recorded as dead, death will be count as PFS event.|From randomization until the date of first documented progression or date of death from any cause, whichever came first.|The intention-to-treat set will contain all subjects in the Randomized set (RND) set subjects will be classified according to randomized treatment. The intent-to-treat principle is preserved. The Intention to Treat (ITT) will be used for analyses of PFS, OS, ORR and DCR.|||months||95% Confidence Interval|Median
2597559|NCT02196675|Secondary|Time to Chest Tube Removal|Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||days||Standard Deviation|Mean
2597560|NCT02196675|Secondary|Volume of Estimated Intra-operative Blood Loss||Blood loss intra-op and up to 5 days post-op|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||milliliters||Standard Deviation|Mean
2597561|NCT02196675|Secondary|Length of Stay (LOS)|Determined as the length of time in days from hospital admission to initial hospital discharge|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure and had complete data. One subject was missing the hospital discharge date, thus length of stay could not be calculated.|||days||Standard Deviation|Mean
2597562|NCT02196675|Secondary|Occurrence of Postoperative Air Leaks|Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).|Post-operative period through hospital discharge and follow-up at Day 30|ll subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||percentage of participants||95% Confidence Interval|Number
2597563|NCT02196675|Primary|Occurrence of Prolonged Air Leaks|Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||percentage of participants||95% Confidence Interval|Number
2597573|NCT02196168|Secondary|Levels of Pharmacodynamic Biomarkers|Predictors of clinical outcomes will be investigated using logistic regression, Cox proportional hazards regression and/or generalized estimating equations as appropriate. Descriptive statistics and plotting of data will be used to better understand potential relationships.|Pre-dose, at 4-8 hours on day 3 or 20-24 hours on day 4|No data are available as decision was made by PI not to do the analysis due to small number of patients||||||
2607311|NCT02091752|Secondary|Proportion of Patients Achieving ≥35% Reduction From Baseline in Spleen Volume||Week 24|The study was terminated early due to low enrollment. Analysis was not done.||||||
2597564|NCT02196506|Secondary|Change From End of Phase A to End of Phase B in MADRS Total Score for the Subpopulations With Anxious Distress as Specified in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).|To assess the change from end of Phase A (Week 8) to end of Phase B (Week 14) in MADRS Total Score for the subpopulations with anxious distress as specified in DSM-V. The MADRS was utilized as the primary efficacy assessment of the participant's level of depression and was administered utilizing the Structured Interview Guide for the MADRS (SIGMA). The MADRS consisted of 10 items each with 7 defined grades of severity. The 10 items were apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score was 60; 0, no symptom; 60, severely affected.|From baseline (end of Phase A [Week 8]) to week 14|Subpopulation of Anxious Distress Sample: Comprised of all participants in the Efficacy Sample who had anxious distress as specified in DSM-V.|||Units on a scale||Standard Error|Least Squares Mean
2597565|NCT02196506|Secondary|Change From End of Phase A to End of Phase B in MADRS Total Score for the Subpopulation With <25% Improvement From Baseline of Phase A to End of Phase A in MADRS Total Score|To assess the change from end of Phase A (Week 8 visit) to end of Phase B (Week 14 visit) in MADRS Total Score for the subpopulation with < 25% improvement from baseline of Phase A (Week 0) to end of Phase A (Week 8) in MADRS Total Score. The MADRS was utilized as the primary efficacy assessment of the participant's level of depression and was administered utilizing the Structured Interview Guide for the MADRS (SIGMA). The MADRS consisted of 10 items each with 7 defined grades of severity. The 10 items were apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score was 60; 0, no symptom; 60, severely affected.|From baseline (end of Phase A [Week 8]) to week 14|Subpopulation of <25% Improvement Sample: Comprised of all participants in the Efficacy Sample who had <25% improvement at the end of Phase A in MADRS Total Score.|||Units on a scale||Standard Error|Least Squares Mean
2597566|NCT02196506|Secondary|Change in the Sheehan Disability Scale (SDS) From Baseline to End of Treatment|To assess the change in the Sheehan Disability Scale (SDS) Score (the mean of 3 individual item scores) from Baseline (End of Phase A [Week 8]) to Week 14 (End of Phase B). SDS was a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life, and family life/home responsibility. Each item was scored using a scale of 0 to 10 (a higher score indicates symptoms have disrupted work, social life, and family life/home responsibility extremely). The maximum total score was 30; 0 = not at all, to 30 = extremely.|From baseline (end of Phase A [Week 8]) to week 14|The primary analysis was performed on Efficacy Sample which included all randomized participants who took at least one dose of trial medication in Phase B and who have both an end of Phase A (Week 8) and at least one post-randomization MADRS Total Score during Phase B.|||Units on a scale||Standard Error|Least Squares Mean
2597567|NCT02196506|Primary|Change in the Montgomery-Asberg Depression|To assess the change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score from Baseline (End of Phase A [Week 8]) to Week 14. The MADRS was utilized as the primary efficacy assessment of the participant's level of depression and was administered utilizing the Structured Interview Guide for the MADRS (SIGMA). The MADRS consisted of 10 items each with 7 defined grades of severity. The rater decided whether the rating lied on predefined scale steps (0, 2, 4, 6) or between them (1, 3, 5). The 10 items were apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score was 60; 0, no symptom; 60, severely affected.|From baseline (end of Phase A [Week 8]) to week 14|The primary analysis was performed on Efficacy Sample which included all randomized participants who took at least one dose of trial medication in Phase B and who have both an end of Phase A (Week 8) and at least one post-randomization MADRS Total Score during Phase B.|||Units on a scale||Standard Error|Least Squares Mean
2597568|NCT02196259|Primary|Functional Connectivity|"The imaging experiments and analysis of subject-specific data will lead to maps corresponding to separate measures: resting state functional connectivity maps. The outcome of interest is whether ketamine reduces functional connectivity between the anterior (subgenual anterior cingulate corte, sgACC) and posterior regions (posterior cingulate cortex, PCC) of the default mode network. This is the z-score of the functional connectivity correlation.~Timepoints for Initial fMRI were: Time 1:Immediately before Infusion, Time 2: After washout (Approx. 40 min after end of infusion).~Timepoints for Depression were: Time 1: 1 Day before Infusion, Time 2: 1 Day after Infusion"|8 minutes scans, acquired between 1 day and 3 days (see above)|Primary outcome measure is functional connectivity as measured using the MRI scans, which is only in the Initial MRI and Depression Arms.|||z score||Standard Error|Mean
2597569|NCT02196168|Secondary|Progression Free Survival|Estimated in each group by the Kaplan Meier method and differences between groups will be calculated by the log rank test. Hazard ratios for each group will be estimated using the Cox Regression model.|Time from start of treatment to time of progression or death, whichever occurs first, assessed at 12 months||||months||95% Confidence Interval|Median
2597570|NCT02196168|Secondary|Progression Free Survival|Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression (20% increase in the sum of the longest diameter of target lesions or a measurable increase in a non-target lesion, or the appearance of new lesions) or death, whichever occurs first.|Time from start of treatment to time of progression or death, whichever occurs first, assessed at 6 months||||months||95% Confidence Interval|Median
2597571|NCT02196168|Secondary|Overall Survival|Estimated in each group by the Kaplan Meier method and differences between groups will be calculated by the log rank test. Hazard ratios for each group will be estimated using the Cox Regression model.|12 months||||months||95% Confidence Interval|Median
2597572|NCT02196168|Secondary|Levels of Predictive Biomarkers|Predictors of clinical outcomes will be investigated using logistic regression, Cox proportional hazards regression and/or generalized estimating equations as appropriate. Descriptive statistics and plotting of data will be used to better understand potential relationships.|Up to day 4 of course 1|No data are available as decision was made by PI not to do the analysis due to small number of patients.||||||
2597575|NCT02196168|Primary|Overall Response Rate (Complete Plus Partial Response) Using RECIST Criteria v1.1|Per Response Evaluation Criteria in solid Tumors (RECIST1.1) Target lesions are assessed as Complete Response(CR), Disappearance of all target lesions; Partial Response (PR),30% decrease in the sum of the diameters of target lesions; Progressive Disease (PD), At least a 20% increase (minimum 5 mm) from smallest sum (nadir); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Nontarget lesions are assessed as Complete Response (CR), Disappearance of all non-target lesions; Non-CR/Non-PD, Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits; Progressive Disease (PD),Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions; Overall Response(OR); PR=CR+non-CR/non-PD,SD=SD+non-PD; PD=PD+presence of any non-target lesions|Up to 1 year||||Participants|||Number
2597576|NCT02196077|Secondary|Change From Baseline in Average Daily Use of Rescue Ventolin HFA Over the Last Week of Treatment||Visit 12-13 (7 days)|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods|||Puffs||95% Confidence Interval|Least Squares Mean
2597577|NCT02196077|Secondary|Transition Dyspnea Index (TDI) Focal Score on Day 29|Min/Max Range of TDI scale -9 (major deterioration) to +9 (major improvement)|Day 29|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods.|||Index||Full Range|Least Squares Mean
2597578|NCT02196077|Secondary|Forced Vital Capacity (FVC) AUC0-12 on Day 29||Day 29|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods|||Liters||95% Confidence Interval|Least Squares Mean
2597579|NCT02196077|Secondary|Peak Change From Baseline in FEV1 on Day 1||Day 1|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods|||Liters||95% Confidence Interval|Least Squares Mean
2597580|NCT02196077|Secondary|Peak Change From Baseline in FEV1 (in Liters) Day 29||Day 29|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods|||Liters||95% Confidence Interval|Least Squares Mean
2597581|NCT02196077|Secondary|Peak Change From Baseline in FEV1 (in Liters) Day 15||Day 15|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods|||Liters||95% Confidence Interval|Least Squares Mean
2597582|NCT02196077|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1 Over 28 Days||Over 28 days|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods|||Liters||95% Confidence Interval|Least Squares Mean
2597583|NCT02196077|Primary|FEV1 AUC0-12 on Day 29|Change from Baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12)|Day 29|MITT Population is a subset of the ITT population which includes subjects who received treatment and had post-treatment efficacy data from at least two Treatment Periods.|||Liters||95% Confidence Interval|Least Squares Mean
2597584|NCT02195986|Secondary|Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Comparison to Placebo|Evaluation and comparison between Estradiol Vaginal Cream, Estrace®, and Placebo treatment groups of the change from baseline in the most bothersome vulvar and/or vaginal atrophy symptom including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or vaginal bleeding associated with sexual activity as identified by each subject. A score ≤ 1 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment success. A score ≥ 2 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment failure.|Day 8|The Intent-to-treat (ITT) population was used for the Superiority Analysis which consisted of all randomized subjects that used at least one dose of Estradiol Vaginal Cream, Estrace®, or Placebo and returned for at least one post-baseline visit|||Participants|||Count of Participants
2597585|NCT02195986|Secondary|Comparison of the Number of Participants With Treatment Success for the Patient Self-assessment of the Symptoms of Vulvar and Vaginal Atrophy - Equivalence|Evaluation and comparison between Estradiol Vaginal Cream and Estrace® treatment groups of the change from baseline in the most bothersome vulvar and/or vaginal atrophy symptom including vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or vaginal bleeding associated with sexual activity as identified by each subject. A score ≤ 1 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment success. A score ≥ 2 on Study Day 8 for the most bothersome symptom as identified by the subject at baseline (Study Day -1) was considered a treatment failure.|Day 8|The Per Protocol population was used for the secondary endpoint equivalence comparison which consisted of all randomized subjects that were dosed with 75%-125% of scheduled applications of Test or Reference and completed secondary endpoint evaluation on Study Day 8 +/- 2 days with no protocol violations that would affect treatment evaluation|||Participants|||Count of Participants
2597586|NCT02195986|Primary|Primary Endpoint (Vaginal Cytology + Vaginal pH) Comparison of Active Treatments to Placebo|"Treatment comparison of the proportion of patients in the Per Protocol (PP) population who received either Estradiol Vaginal Cream, Estrace®, or Placebo that were identified as responders at the end of the treatment period on Study Day 8.~A responder was defined as a patient with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology AND vaginal pH ≤ 5.0 with a change from baseline vaginal pH of at least 0.5."|Study Day 8|The Intent-to-treat (ITT) population was used for the comparison of active treatments versus placebo analysis which consisted of all randomized subjects that used at least one dose of Test, Reference or Placebo and returned for at least one post-baseline visit.|||Participants|||Count of Participants
2597727|NCT02195349|Secondary|t1/2 for GSK2831781 5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose|PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.||||||
2597587|NCT02195986|Primary|Primary Endpoint (Vaginal Cytology + Vaginal pH) Equivalence|"Treatment comparison of the proportion of patients in the Per Protocol (PP) population who received either Estradiol Vaginal Cream or Estrace® that were identified as responders at the end of the treatment period on Study Day 8.~A responder was defined as a patient with at least a 25% reduction from baseline in the sum of % basal/parabasal + % intermediate cells on vaginal cytology AND vaginal pH ≤ 5.0 with a change from baseline vaginal pH of at least 0.5."|Study Day 8|The Per Protocol population was used for the primary endpoint equivalence comparison which consisted of all randomized subjects that were dosed with 75%-125% of scheduled applications of Test or Reference and completed primary endpoint evaluation on Study Day 8 +/- 2 days with no protocol violations that would affect treatment evaluation|||Participants|||Count of Participants
2597588|NCT02195895|Secondary|Bone-specific Alkaline Phosphatase (BSAP)|The mean percent change in bone-specific alkaline phosphatase (BSAP) after 12 months of treatment. BSAP is a bone marker found in blood serum and measures the rate of bone breakdown.|12 months||||Percent change||95% Confidence Interval|Mean
2597589|NCT02195895|Secondary|Amino-terminal Propeptide of Type 1 Collagen (P1NP)|The mean percent change in amino-terminal of type 1 collagen (P1NP) from baseline after 12 months of treatment. P1NP is a bone marker found in blood serum and provides information about how fast the body is making new bone.|12 months||||Percent change||95% Confidence Interval|Mean
2597590|NCT02195895|Secondary|BMD by DXA at the Lumbar Spine|The mean percent change in bone mineral density (BMD) in the lumbar spine after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams.|12 months||||Percent change||95% Confidence Interval|Mean
2597591|NCT02195895|Secondary|C-terminal Telopeptide (CTX)|The mean percent change in C-terminal telopeptide (CTX) from baseline after 12 months of treatment. CTX is a bone marker found in blood serum and measures the rate of bone breakdown.|12 months||||Percent change||95% Confidence Interval|Mean
2597592|NCT02195895|Primary|BMD of Total Hip by DXA|The mean percent change in bone mineral density (BMD) of the hip after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams.|12 months||||Percent change||95% Confidence Interval|Mean
2597593|NCT02195869|Secondary|Phase 2b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD|Number of Participants With Adverse Events as a Measure of Safety and Tolerability of Ibrutinib|From first dose with study drug until 30 days after the last dose of study drug, up to 36.7 months|Phase 2 subjects includes all subjects who participated in Phase 1b|||Participants|||Count of Participants
2597594|NCT02195869|Secondary|Percentage of Participants With Overall Improvement in Lee cGVHD Symptom Summary Score|"Subject reported improvement in symptom burden. The symptom burden will be measured according to the Lee cGVHD Symptom Scale. A change in >7 points on the Lee cGVHD Symptom Scale will be considered significant and relates to improvement in quality of life.~A score is calculated for each subscale by taking the mean of all items completed if more than 50% were answered and normalizing to a 0 to 100 scale. A total summary score is calculated as the average of these 7 subscales if at least 4 subscales have valid scores.~There are 7 subscales (Skin, Energy, Lung, Eye, Nutrition, Mouth and Psychological) with ratings as follow: 0- Not at all, 1- Slightly, 2 Moderately, 3 Quite a bit, 4-Extremely; with a lower values representing a better outcome."|Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.|All subjects who received at least 1 dose of ibrutinib at the recommended Phase 2 dose.|||percentage of participants||95% Confidence Interval|Number
2597595|NCT02195869|Secondary|Corticosteroid Requirement Changes Over Time|Average daily corticosteroid dose assessed each week.|Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.|Phase 2 subjects includes all subjects who participated in Phase 1b.|||Daily Dose of Steroid by Weight (mg/kg/d||Full Range|Median
2597596|NCT02195869|Secondary|To Evaluate the Clinical Efficacy of Ibrutinib in Steroid Dependent/Refractory cGVHD by Measuring: Duration of Response (DOR)|For subjects who achieved an NIH-defined CR or PR, the interval between the date of initial documentation of a response and the date of first documented evidence of PD, death, or date of censoring if applicable.|Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.|Phase 2 subjects includes all subjects who participated in Phase 1b|||Median||95% Confidence Interval|Median
2597597|NCT02195869|Secondary|Sustained Response Rate as the Percentage of Participants With Sustained Response|For subjects who achieved an NIH-defined CR or PR, the proportion of subjects who achieved CR or PR that was sustained for at least 20 weeks (140 days). Intermittent SD was also acceptable.|Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.|Phase 2 subjects include all subjects who participated in phase 1b. Subjects evaluated for sustained response includes participants who had achieved an NIH-defined CR or PR.|||percentage of participants||95% Confidence Interval|Number
2597598|NCT02195869|Primary|Phase 2: Overall Response Rate as the Percentage of Participants With Response|Overall Response Rate is defined as the proportion of subjects who achieved complete response (CR) or partial response (PR). Response criteria are based on NIH cGVHD Response assessment (Pavletic 2006; Measurement of Therapeutic Response, ASBMT Web site).|Analysis was conducted with the data extraction date of 15 Sep 2017, with a median follow-up time of 25.56 months.|Efficacy analyses were performed using the All-treated Population (N = 42)|||percentage of participants||95% Confidence Interval|Number
2597599|NCT02195869|Primary|Phase 1b: To Evaluate the Safety and Tolerability of Ibrutinib in Steroid Dependent/Refractory cGVHD.|Number of participants with dose-limiting toxicities as a measure of safety profile to determine recommended dose of ibrutinib|28 treatment days after last subject enrolled in Phase 1 dose level(s).|Endpoint only includes Phase 1 data.|||Participants|||Count of Participants
2597600|NCT02195713|Primary|Urine Output of SOC Device Versus Accuryn|Urine output as recorded by the SOC when connected to a standard Foley catheter and standard urinary drainage tube will be compared to urine output recorded by Accuryn and the SOC when connected to a standard Foley catheter and the Accuryn Drainage Tube.|2 - 5 days||||Patients with airlocks||95% Confidence Interval|Number
2597790|NCT02195349|Secondary|Maximum Observed Concentration (Cmax) for GSK2831781 0.0003 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose|PK population.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597601|NCT02195700|Secondary|Change in Locally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using MMRM Analysis|"This outcome is similar to the primary outcome except that AIMS was read locally.~AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and scored items. This outcome reports the local reading of AIMS data.~This outcome sums items 1 through 7 which cover orofacial movements, and extremity and truncal dyskinesia. Severity ratings were from 0 (none) to 4 (severe) for a total scale of 0 (no orofacial, truncal, and extremity dyskinesia) to 28 (severe orofacial, truncal, and extremity dyskinesia). A negative change from baseline score indicates improvement.~A MMRM analysis with change from baseline in AIMS score as dependent variable was used. The model included fixed effects for treatment, time point (weeks 2, 4, 6, 9, and 12), treatment-by-time point interaction, DRA status, and baseline AIMS as a covariate."|Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12|modified intent to treat analysis. Number analyzed includes participants who had week 12 readings minus one placebo patient missing a baseline reading.|||units on a scale||Standard Error|Least Squares Mean
2597602|NCT02195700|Secondary|Cumulative Percentage of Abnormal Involuntary Movement Scale (AIMS) Responders by Response Level (Percentage Improvement From Baseline) at Week 12|"Response level represents the % improvement in AIMS from baseline. AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and scored items. AIMS was digitally video recorded using a standard protocol and independently reviewed by blinded central raters who were experts in movement disorders.~This outcome sums items 1 through 7 which cover orofacial movements, and extremity and truncal dyskinesia. Severity ratings were from 0 (none) to 4 (severe) for a total scale of 0 (no orofacial, truncal, and extremity dyskinesia) to 28 (severe orofacial, truncal, and extremity dyskinesia).~Patients with a missing AIMS score were considered to be AIMS nonresponders."|Day 0 (Baseline), Week 12|modified intent to treat population.|||percentage of participants|||Number
2597603|NCT02195700|Secondary|Percentage Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using MMRM Analysis|"AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and scored items. AIMS was digitally video recorded using a standard protocol and independently reviewed by blinded central raters who were experts in movement disorders.~This outcome sums items 1 through 7 which cover orofacial movements, and extremity and truncal dyskinesia. Severity ratings were from 0 (none) to 4 (severe) for a total scale of 0 (no orofacial, truncal, and extremity dyskinesia) to 28 (severe orofacial, truncal, and extremity dyskinesia). A negative percent change from baseline score indicates improvement.~The MMRM model includes fixed effects for treatment, time point (weeks 2, 4, 6, 9, 12), treatment-by-time point interaction, DRA status, and baseline AIMS as a covariate. Patient is a random effect."|Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12|modified intent to treat population. Number analyzed includes participants who had week 12 readings minus one placebo patient missing a baseline reading.|||percentage change||Standard Error|Least Squares Mean
2597604|NCT02195700|Secondary|Participants With Adverse Events for the Overall Treatment Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator and includes possibly, probably and definitely related categories. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 12|Safety population|||Participants|||Count of Participants
2597605|NCT02195700|Secondary|Change From Baseline to Week 12 in the Modified Craniocervical Dystonia Questionnaire (CDQ-24)|The CDQ-24 is a disease-specific quality of life questionnaire developed for use in patients with craniocervical dystonia, including both cervical dystonia (CD) and blepharospasm (BPS). The CDQ 24 was modified such that the questions focus more directly on the impact of TD (as opposed to CD/BPS) on quality of life. The following domains are evaluated in the CDQ-24: stigma, emotional well-being, pain, activities of daily living, and social/family life. Each of the 24 questions were rated by patients on a scale of 0=no impairment to 4=severest impairment for a total scale of 0 (no impairment) to 96 (severe impairment). Negative change from baseline scores indicate improvement.|Day 0 (Baseline), Week 12 with last observation carried forward|modified intent to treat population|||units on a scale||Standard Error|Least Squares Mean
2597606|NCT02195700|Secondary|Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC)|"The PGIC is a single-item questionnaire that asks the patient to assess their TD symptoms at specific visits after initiating therapy. The PGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy. A treatment success was defined as much improved or very much improved at the week 12 visit. Patients whose status at week 12 was not known, as well as patients who were not much improved or very much improved at the week 12 visit, were considered treatment failures."|Week 12|modified intent to treat population|||percentage of participants|||Number
2597607|NCT02195700|Secondary|Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC)|"The CGIC is a single-item questionnaire that asks the investigator to assess a patient's TD symptoms at specific visits after initiating therapy. The CGIC uses a 7 point Likert Scale, ranging from very much worse (-3) to very much improved (+3), to assess overall response to therapy. A treatment success was defined as much improved or very much improved at the week 12 visit. Patients whose status at week 12 was not known, as well as patients who were not much improved or very much improved at the week 12 visit, were considered treatment failures."|Week 12|modified intent to treat population|||percentage of participants|||Number
2597628|NCT02195518|Secondary|Change From Baseline in Chemistry Parameter: Creatinine Clearance Rate|Blood samples were collected to analyze the chemistry parameter: creatinine clearance rate. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144|Safety analysis population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Milliliter per minute||Standard Deviation|Mean
2597608|NCT02195700|Primary|Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using Mixed Model Repeated Measures (MMRM) Analysis|"AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and scored items. AIMS was digitally video recorded using a standard protocol and independently reviewed by blinded central raters who were experts in movement disorders.~This outcome sums items 1 through 7 which cover orofacial movements, and extremity and truncal dyskinesia. Severity ratings were from 0 (none) to 4 (severe) for a total scale of 0 (no orofacial, truncal, and extremity dyskinesia) to 28 (severe orofacial, truncal, and extremity dyskinesia). A negative change from baseline score indicates improvement.~A MMRM analysis with change from baseline in AIMS score as dependent variable was used. The model included fixed effects for treatment, time point, treatment-by-time point interaction, DRA status, and baseline AIMS as a covariate. An unstructured covariance model was used."|Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12|The Modified ITT (mITT) Population was defined as all patients in the ITT Population who received study drug and had at least 1 centrally read post-baseline assessment of the AIMS from at least 1 scheduled post-baseline time point. Number analyzed includes participants who had week 12 readings minus one placebo patient missing a baseline reading.|||units on a scale||Standard Error|Least Squares Mean
2597609|NCT02195687|Secondary|Percentage of Subjects Achieving None or Mild on the Subject's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)|The subject assessed the severity of their CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug|||Percentage of Subjects|||Number
2597610|NCT02195687|Secondary|Percentage of Subjects Assessing Their Age-related Facial Appearance as Looking Younger on the Self-Perception of Age (SPA) Questionnaire|Subjects assessed their age-related appearance according to the following on the SPA questionnaire: look my current age, look younger, and look older when compared to their baseline assessment. The percentages of subjects who reported looking younger amongst subjects who rated themselves as looking their current age or older at baseline are noted.|Baseline, Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug and rated themselves as looking their current age or older at baseline|||Percentage of Subjects|||Number
2597611|NCT02195687|Secondary|Percentage of Subjects Reporting Their Global Change in Appearance as Very Much Improved or Much Improved Using the 7-point Subject's Global Assessment of Change in CFL (SGA-CFL)|Subjects assessed their global change in appearance using the 7-point SGA-CFL scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse. The percentage of subjects reporting very much improved or much improved are noted.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug|||Percentage of Subjects|||Number
2597612|NCT02195687|Secondary|Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Maximum Smile on the 4-point FWS-A|The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentages of subjects with at least a 1-grade improvement are noted.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug|||Percentage of Subjects|||Number
2597613|NCT02195687|Secondary|Percentage of Subjects With a ≥ 1-grade Improvement on the Investigator's Assessment of CFL Severity at Rest Using the 4-point FWS-A|The Investigator assessed the severity of the subject's CFLs at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe among subjects rated as at least mild at baseline by the Investigator. The percentages of subjects with at least a 1-grade improvement are noted.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug|||Percentage of Subjects|||Number
2597614|NCT02195687|Primary|Percentage of Subjects Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)|The Investigator assessed the severity of the subject's CFLs at maximum smile using the 4-point FWS-A where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a score of none or mild at Day 30 is reported.|Day 30|Modified Intent-to-Treat: all randomized subjects who received at least 1 injection of study drug|||Percentage of Subjects|||Number
2597615|NCT02195622|Primary|Morcellation Rate|"Operatively, the amount of enucleated tissue removed (in grams) per the time for complete removal (in minutes) will be recorded as morcellation rate."|Collected intraoperatively upon completion of enucleation (surgical removal) of the extra benign prostate tissue growth||||grams/minute||Full Range|Mean
2597616|NCT02195583|Secondary|Percentage Comparative Acid Resistance (% CAR)|Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % CAR was calculated using the equation: % CAR= [(D2-R)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; R= Indentation length (μm) of enamel after in situ remineralization; D1= Indentation length (μm) after first acid challenge; D2= Indentation length (μm) after second acid challenge.|Baseline to 4 hours|The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.|||Percentage of CAR||Standard Error|Least Squares Mean
2597629|NCT02195518|Secondary|Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridian, Phosphorus, Calcium and Fasting Blood Glucose.|Blood samples were collected to analyze the chemistry parameters: BUN, potassium, sodium, chloridian, phosphorus, calcium and fasting blood glucose. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144|Safety analysis population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Millimoles per liter||Standard Deviation|Mean
2607312|NCT02091752|Primary|Proportion of Patients Achieving ≥20% Reduction From Baseline in Spleen Volume||Week 24|The study was terminated early due to low enrollment. Analysis was not done.||||||
2597617|NCT02195583|Secondary|Percentage Net Acid Resistance (% NAR)|Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % NAR was calculated using the equation: % NAR= [(D1-D2)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; D1= Indentation length (μm) after first acid challenge and D2= Indentation length (μm) after second acid challenge.|Baseline to 4 hours|The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.|||Percentage of NAR||Standard Error|Least Squares Mean
2597618|NCT02195583|Secondary|Enamel Fluoride Uptake|The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling sample was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2).|Baseline to 4 hours|The main population for the secondary efficacy analysis was the PP population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.|||microgram per square centimeter(μg/cm^2)||Standard Error|Least Squares Mean
2597619|NCT02195583|Primary|Percentage Surface Microhardness Recovery (% SMHR)|Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the equation: % SMHR= [(D1-R)/(D1-B)]*100 Where B = indentation length (μm) of sound enamel at baseline; D1 = indentation length (μm) after first acid challenge; R = indentation length (μm) after in situ remineralization.|Baseline to 4 hours|The primary population for the efficacy analysis was the Per Protocol (PP) population, including participants with a protocol violation affecting some (but not all) of the efficacy assessments. However, data from assessments when a violation occurred were excluded.|||Percentage of SMHR||Standard Error|Least Squares Mean
2597620|NCT02195531|Secondary|Participant's Feedback on Educational Pamphlets - Leaflet Assessment|"Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.~Participants that received the leaflet were asked 15 questions regarding it. The questions were on a scale of 0 to 5, 0 being strongly disagree and 5 being strongly agree.~The average of the scores were calculated and analyzed monthly."|2 months|As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.|||units on a scale||Standard Deviation|Mean
2597621|NCT02195531|Secondary|Participant's Feedback on Educational Pamphlets - Motiviation|"Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.~Participants were asked about there motivation to use CPAP with two questions. These questions were on a scale of 0 to 10, 0 being not at all, 5 being somewhat, and 10 very much.~The average of the questions were analyzed."|3 months|As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.|||units on a scale||Standard Deviation|Mean
2597622|NCT02195531|Secondary|Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale|"Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.~Participants answered 5 questions regarding self-efficacy of use of CPAP. This was on a scale of 0 to 5, 0 being disagree completely and 5 being completely agree.~The average of each question was analyzed."|3 months|As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.|||units on a scale||Standard Deviation|Mean
2597623|NCT02195531|Secondary|Participant's Feedback on Educational Pamphlets - Importance Scale|"Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.~Participants answered one questions about the importance of CPAP. This was was on a scale of 0 to 5, 0 being not important at all and 5 extremely important."|3 months|As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.|||units on a scale||Standard Deviation|Mean
2597624|NCT02195531|Secondary|Participant's Feedback on Educational Pamphlets - Expectations Scale|"Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.~Participants answered 3 questions about the expected effectiveness of CPAP. These questions were on a scale of 0 to 5, 0 being not effective at all and 5 being extremely effective.~The average response for each questions was analyzed."|3 months|As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments.|||units on a scale||Standard Deviation|Mean
2597625|NCT02195531|Primary|Adherence|Average usage days per week.|3 months||||days per week||Standard Deviation|Mean
2597626|NCT02195531|Primary|Nightly Adherence|Average usage hours per night|3 months||||hours||Standard Deviation|Mean
2597627|NCT02195518|Secondary|Change From Baseline in Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR)|Blood samples were collected to analyze the chemistry parameter: eGFR. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144|Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Grams per liter||Standard Deviation|Mean
2597680|NCT02195414|Secondary|OCT Endpoint||5 years||2020-10-31|10/2020||||
2597681|NCT02195414|Secondary|OCT Endpoint||2 years||2017-10-31|10/2017||||
2597682|NCT02195414|Secondary|OCT Endpoint|proportion of covered struts, malapposed struts; neointimal hyperplasia (NIH) area, volume; NIH volume obstruction.|6 months||2016-04-30|04/2016||||
2597683|NCT02195414|Secondary|Angiographic Endpoint||5 years||2020-10-31|10/2020||||
2597630|NCT02195518|Secondary|Change From Baseline in Chemistry Parameters: Albumin, Total Protein|Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144|Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Grams per liter||Standard Deviation|Mean
2597631|NCT02195518|Secondary|Change From Baseline in Chemistry Parameters: Total Billirubin, Direct Bilirubin, Serum Creatinine|Blood samples were collected to analyze the chemistry parameters: total billirubin,direct bilirubin and serum creatinine. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 0) and at Weeks, 12,24,36,48,60,72,84,96,108,120,132,and 144|Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Micromoles per liter||Standard Deviation|Mean
2597632|NCT02195518|Secondary|Change From Baseline in Chemistry Parameters: ALT, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)|Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, CK, LDH. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 0) and at Weeks 12,24,36,48,60,72,84,96,108,120,132,and 144|Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||International units per liter||Standard Deviation|Mean
2597633|NCT02195518|Secondary|Change From Baseline in Red Blood Cells (RBC)|Blood samples were collected to analyze RBC values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144|Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Trillion cells per liter||Standard Deviation|Mean
2597634|NCT02195518|Secondary|Change From Baseline in Hemoglobin (Hb)|Blood samples were collected to analyze Hb values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144|Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Grams per liter||Standard Deviation|Mean
2597635|NCT02195518|Secondary|Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets|Blood samples were collected to analyze the hematology parameters: WBC, basophils, eosinophils, lymphocytes, monocytes, neutrophils and platelets. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 0) and at Weeks 24, 48, 72, 96, 120 and 144|Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Billion cells per liter||Standard Deviation|Mean
2597636|NCT02195518|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs|An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is defined as AE occurred on or after the first dose date of study drug, SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events associated with liver injury and impaired liver function. The Safety analysis (SA) Population was defined as all participants who received at least one dose of study medication and have at least one post Baseline safety assessment.|Up to Week 144|Safety Analysis Population.|||Participants|||Number
2597637|NCT02195518|Secondary|Percentage of Participants Who Experienced Viral Breakthrough up to Week 144|Viral breakthrough was defined as 1 log increase in HBV DNA from nadir determined by two sequential HBV DNA measurements. Percentage of participants who experienced viral breakthrough at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144 have been presented.|At Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120,132, and 144|mITT Population.|||Percentage of Participants|||Number
2597638|NCT02195518|Secondary|Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 48, 96, and 144 in Participants Who Had Abnormal ALT at Baseline|Blood samples were collected for evaluation of ALT at indicated time points. ALT normalization was defined as measurement less than or equal to the upper limit of the normal range. Normal range for ALT is 7 to 56 International Units per liter. Percentage of participants with ALT normalization at Weeks 48, 96, and 144 in Participants who had abnormal ALT at Baseline (Day 0) have been presented.|At Weeks 48, 96, and 144|mITT Population. Only those participants with data available at the specified data points were analyzed.|||Percentage of Participants|||Number
2597639|NCT02195518|Secondary|Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Weeks 48, 96, and 144|Serological response was assessed at Weeks 48, 96 and 144 in participants with negative HBeAg at Baseline (Day 0). HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive.|At Weeks 48,96, and 144|mITT Population. Only those participants with data available at the specified data points were analyzed.|||Percentage of Participants|||Number
2597640|NCT02195518|Secondary|Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion or Hepatitis B s Antigen (HBsAg) Loss and HBsAg Seroconversion at Weeks 48, 96, and 144|Serological response was assessed at Weeks 48, 96 and 144 in participants with Positive HBeAg at Baseline (Day 0). It was presented as HBeAg Loss, HBeAg Seroconversion, HBsAg Loss and HBsAg Seroconversion. HBeAg Loss was defined as HBeAg changed to be negative. HBeAg seroconversion was defined as HBeAg changed to negative and HBeAb was positive. HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive.|At Weeks 48, 96 and 144|mITT Population. Only those participants with data available at the specified data points were analyzed.|||Percentage of Participants|||Number
2597684|NCT02195414|Secondary|Angiographic Endpoint||2 years||2016-10-31|10/2016||||
2597641|NCT02195518|Secondary|Change From Baseline in Logarithm to the Base 10 (Log 10) Reduction in Serum HBV DNA at Week 48, 96 and 144|Log10 reduction in serum HBV DNA was analyzed by patterns of mutation. The patterns of mutation were summarized by 2 categories. Category 1 included wild-type, LAM-R (Lamivudine-resistant), ADV-R (Adefovir-resistant) and ETV-R (Entecavir-resistant). Category 2 included Wild type, ADV-R single mutation, ADV-R double mutation and other mutation. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day 0) and at Weeks 48,96, and 144|mITT Population. All the participants in the study were analyzed (213 Participants) but only the participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Log 10 (IU/mL)||Standard Deviation|Mean
2597642|NCT02195518|Secondary|Percentage of Participants in the Subgroup With Confirmed Multi-drug Resistance Mutations at Baseline With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144|Serum samples were collected and analyzed for HBV DNA levels at indicated time points. Resistance surveillance of the HBV polymerase gene were performed by direct sequencing for all participants at Baseline. Day 0 was considered as Baseline. Percentage of participants in the subgroup with confirmed multi-drug resistance mutations at Baseline with serum HBV DNA <20 IU/mL and serum HBV DNA <69 IU/mL at Weeks 48, 96 and 144 have been presented.|At Weeks 48, 96, and 144|mITT Population.|||Percentage of Participants|||Number
2597643|NCT02195518|Secondary|Percentage of Participants With Serum HBV DNA <20 IU/mL and Serum HBV DNA <69 IU/mL at Weeks 48 and 96|HBV DNA level were analyzed using the sensitive HBV test in central laboratory using Roche cobas Taqman HBV test from the blood samples collected at Weeks 48 and 96. Virological response was assessed by proportion of participants with serum serum HBV <20 IU/mL and <69 IU/mL at Weeks 48 and 96. Percentage of participants with serum HBV DNA <20 IU/mL and <69 IU/mL at Weeks 48 and 96 have been presented.|At Weeks 48 and 96|mITT Population.|||Percentage of Participants|||Number
2597644|NCT02195518|Primary|Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Unit Per Milliliter (IU/mL) at Week 144|HBV DNA level were analyzed using the sensitive HBV test in central laboratory using Roche cobas Taqman HBV test from the blood samples collected at Week 144. A 95 percent confidence interval (CI) was constructed by normal approximation and continuity correction method. Percentage of participants with serum HBV DNA <20 IU/mL at Week 144 have been presented. The Modified Intent-to-treat (mITT) Population was defined as all recruited participants who received at least one dose of study medication.|At Week 144|mITT Population.|||Percentage of Participants|||Number
2597645|NCT02195479|Secondary|Change From Baseline in EuroQol 5 Dimensions-5 Level (EQ-5D-5L) Utility Score|EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The EQ-5D-5L descriptive system provides a profile of the participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of the individual based on the UK scoring algorithm.|Baseline, Months 3, 6, 9, 12 and 18|ITT population: participants randomized into the study; classified according to assigned treatment group,regardless actual treatment received. 'N' (number of participants analyzed) signifies participants evaluable for this endpoint and 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2597646|NCT02195479|Secondary|Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): Visual Analogue Scale (VAS)|EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.|Baseline, Months 3, 6, 9, 12 and 18|ITT population: participants randomized into the study; classified according to assigned treatment group,regardless actual treatment received. 'N' (number of participants analyzed) signifies participants evaluable for this endpoint and 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||Units on a scale||Standard Deviation|Mean
2597647|NCT02195479|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Emotional Functioning Score|"The EORTC QLQ-C30 is a 30 items self-reporting questionnaire, with a 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire includes 28 items with 4-point Likert type responses from 1-not at all to 4-very much to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall QoL. Scores are transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values indicate deterioration in quality of life or functioning and positive values indicate improvement."|Baseline, Months 3, 6, 9, 12 and 18|ITT population: participants randomized into the study; classified according to assigned treatment group,regardless actual treatment received. 'N' (number of participants analyzed) signifies participants evaluable for this endpoint and 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2597685|NCT02195414|Secondary|Angiographic Endpoint|In-segment In-scaffold, proximal and distal Late lumen loss (mm); In-segment In-scaffold, proximal and distal Minimal lumen diameter(mm); In-segment In-scaffold, proximal and distal Diameter stenosis (%) Angiographic Binary Restenosis (%).|6 months||2016-04-30|04/2016||||
2597686|NCT02195414|Secondary|Scaffold Thrombosis||5 years||2020-10-31|10/2020||||
2597687|NCT02195414|Secondary|Scaffold Thrombosis||4 years||2019-10-31|10/2019||||
2597688|NCT02195414|Secondary|Scaffold Thrombosis||3 years||2018-10-31|10/2018||||
2597648|NCT02195479|Secondary|Percentage of Participants With Best M-protein Response|Percentage of participants with Best M- protein response of 100% reduction and >=90% to < 100% reduction were assessed. Best M-protein response was defined as the maximal percent reduction or the lowest percent increase from baseline in serum M-protein for participants with measurable heavy chain at baseline or urine M-protein for participants without measurable heavy chain, but with measurable light chain disease at baseline. For participants without measurable heavy chain and light chain disease at baseline, best response in serum free light chain (FLC) was defined as the maximal percent reduction or the lowest percent increase from baseline in the difference between involved and uninvolved serum FLC level (dFLC).|Approximately up to 2.4 years|Response-evaluable set: participants have confirmed diagnosis of MM and measurable disease at baseline or screening. Participants must receive at least one component of study treatment, have adequate post-baseline disease assessments. 'n' (number of participants analyzed) signifies number of participants analyzed for each specified category.|||Percentage of participants|||Number
2597649|NCT02195479|Secondary|Time to Next Treatment (TNT)|Time to next treatment is defined as the time from randomization to the start of the next-line treatment.|Approximately up to 2.4 years|ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.|||Months||95% Confidence Interval|Median
2597650|NCT02195479|Secondary|Duration of Response (DOR)|DOR: participants with a confirmed response (PR or better) as time between first documentation of response and disease progression, IMWG response criteria, or death due to PD, whichever occurs first. PD: Increase of 25% from lowest response value in any one of following: Serum M-component (absolute increase>=0.5 g/dL); Urine M-component (absolute increase>=200 mg/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL); Only participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC%(absolute%>=10%); Bone marrow PC's %: absolute%>10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in the size of existing bone lesions or soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.|Up to 2.4 years|"Response-evaluable set: participants who have a confirmed diagnosis of MM and measurable disease at baseline or screening. Participants must have received at least one component of study treatment and have adequate post-baseline disease assessments. N(number of participants analyzed) signifies number of participants evaluable for this endpoint."|||Months||95% Confidence Interval|Median
2597651|NCT02195479|Secondary|Time to Response|Time to response, defined as the time between the date of randomization and the first efficacy evaluation that the participant has met all criteria for PR or better. PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours; If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%.|From randomization to first documented PR or better (up to 2.4 years)|"Response-evaluable population: participants who have a confirmed diagnosis of MM and measurable disease at baseline or screening, must receive at least one component of study treatment and have adequate post-baseline disease assessments. N (number of participants analyzed) signifies number of participants evaluable for this endpoint."|||Months||95% Confidence Interval|Median
2597652|NCT02195479|Secondary|Time to Disease Progression (TTP)|TTP: Time from date of randomization to date of first documented evidence of PD or death due to PD, whichever occurs first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum and urine M-component (absolute increase >=0.5 gram per deciliter [g/dL] and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase >10 milligram per deciliter [mg/dL]); Only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cells (PC)% (absolute % >=10%); Bone marrow PC %: absolute % >10%; Definite development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.|From randomization to either disease progression or death due to PD whichever occurs first (up to 2.4 years)|ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.|||Months||95% Confidence Interval|Median
2597653|NCT02195479|Secondary|Percentage of Participants With Stringent Complete Response (sCR)|sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. CR: Negative immunofixation on the serum and urine; Disappearance of any soft tissue plasmacytomas; <5% plasma cells (PCs) in bone marrow.|From randomization to disease progression (up to 2.4 years)|ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.|||Percentage of participants|||Number
2597654|NCT02195479|Secondary|Progression Free Survival on Next Line of Therapy (PFS2)|Progression-free survival after next-line therapy is defined as the time from randomization to progression on the next line of subsequent antimyeloma therapy or death due to any cause (prior to start of second line of antimyeloma therapy), whichever comes first. Disease progression on next line of treatment was based on investigator judgment.|From randomization to either disease progression or death whichever occurs first (up to 2.4 years)|ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.|||Months||95% Confidence Interval|Median
2597655|NCT02195479|Secondary|Overall Survival (OS)|Overall Survival (OS) was defined as the number of days the date of randomization to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.|From randomization to death (up to approximately 2.4 years)|ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.|||Months||95% Confidence Interval|Median
2597689|NCT02195414|Secondary|Scaffold Thrombosis||2 years||2017-10-31|10/2017||||
2597690|NCT02195414|Secondary|Scaffold Thrombosis||1 year||2016-10-31|10/2016||||
2597656|NCT02195479|Secondary|Percentage of Participants With Negative Minimal Residual Disease (MRD)|The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD (detection of less than 1 malignant cell among 100,000 normal cells) assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10^-5 threshold. MRD was evaluated by using Deoxyribonucleic acid (DNA) sequencing of immunoglobulin genes. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR).|From randomization to disease progression (up to 2.4 years)|ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.|||Percentage of participants|||Number
2597657|NCT02195479|Secondary|Percentage of Participants With Complete Response (CR) or Better|CR or better rate was defined as the percentage of participants with a CR or better (i.e. CR and sCR) as per IMWG criteria. CR: as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow; sCR: CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.|From randomization to disease progression (up to 2.4 years)|ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.|||Percentage of participants|||Number
2597658|NCT02195479|Secondary|Percentage of Participants With Very Good Partial Response (VGPR) or Better|VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response[sCR]) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein level less than (<) 100 milligram (mg) per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and < 5% plasms cells (PCs) in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry.|From randomization to disease progression (up to 2.4 years)|ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.|||Percentage of participants|||Number
2597659|NCT02195479|Secondary|Overall Response Rate (ORR)|The Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better, according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: greater than or equal to (>=) 50 percentage(%) reduction of serum M-protein and reduction in 24 hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|From randomization to disease progression (up to 2.4 years)|ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.|||Percentage of participants|||Number
2597660|NCT02195479|Primary|Progression Free Survival (PFS)|PFS- duration from date of randomization to Progressive disease (PD)/death, whichever occurs first. PD per IMWG criteria-Increase of 25% from lowest response value in one of following: Serum and urine M-component (absolute increase >=0.5 gram per deciliter [g/dL] and >=200 milligram [mg]/24 hours respectively); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase>10 mg/dL); Only participants without measurable serum and urine M-protein levels,without measurable disease by FLC levels,bone marrow Plasma cells (PC) %(absolute % >=10%);Bone marrow PC%: absolute% >10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.|From randomization to either disease progression or death whichever occurs first (up to 2.4 years)|Intent-to-treat (ITT) population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.|||Months||95% Confidence Interval|Median
2597661|NCT02195427|Secondary|Number of Subjects Receiving Re-treatment||Weeks 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits (See participant flow)|||Participants|||Count of Participants
2597662|NCT02195427|Secondary|Number of Subjects Receiving Touch-up Treatment.||Week 2||||Participants|||Count of Participants
2597663|NCT02195427|Secondary|Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up)||Week 2||||mL||Standard Deviation|Mean
2597664|NCT02195427|Secondary|Subject's Satisfaction Score|Subjective 5-point scale with 1 being 'very satisfied' and 5 being 'very dissatisfied'|Weeks 2, 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||units on a scale||Standard Deviation|Mean
2597665|NCT02195427|Secondary|Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire|"The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective.~FACE-Q questionnaire is composed of 5 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely').~The subject was instructed as follows: These questions ask about how you look right now. With your nasolabial folds in mind (the deep lines that run downward from the sides of your nose), in the past week, how much have you been bothered by:, and provided response.~How deep your nasolabial fold are?~How your nasolabial folds look when your face is relaxed (still)?~How old your nasolabial folds make you look?~How your nasolabial folds look when you smile?~How your nasolabial folds look compared with other people your age? To calculate the FACE-Q, outcomes from all 5 questions were pooled and adapted to a scale to 100 units. Data were also transformed so that higher scores reflected a beneficial outcome."|Immediately post-injection, and weeks 2, 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||units on a scale||Standard Deviation|Mean
2597691|NCT02195414|Secondary|Scaffold Thrombosis||6 months||2016-04-30|04/2016||||
2597666|NCT02195427|Secondary|"Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either Much Improved or Improved) on GAI Scale."|"Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of much improved, improved, no change, worse, and much worse that evaluate the aesthetic improvement from baseline.~GAI was assessed using the baseline photograph. Subjects will be instructed: Use a mirror to compare your face to the photograph provided to you and rate the degree of aesthetic improvement by using the following scale.~Each side of the face was assessed independently."|Weeks 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||Participants|||Count of Participants
2597667|NCT02195427|Secondary|"Number of Subjects Scored Either Much Improved or Improved on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE)."|"Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of much improved, improved, no change, worse, and much worse that evaluate the aesthetic improvement from baseline.~GAI was assessed using the baseline photograph. Each side of the face was assessed independently."|Weeks 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||Participants|||Count of Participants
2597668|NCT02195427|Secondary|Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the TI|A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to baseline|Baseline and Weeks 2, 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||percentage of responders||95% Confidence Interval|Number
2597669|NCT02195427|Secondary|Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the WSRS Compared to Baseline Assessed by the BLE|A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to baseline|Baseline and Weeks 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||percentage of responders||95% Confidence Interval|Number
2597670|NCT02195427|Secondary|Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA GA Versus Juvéderm® Ultra XC and TEOSYAL® RHA Deep Lines Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the WSRS Score Assessed by the TI|TEOSYAL® RHA GA = TEOSYAL® RHA Global Action TEOSYAL® RHA DL = TEOSYAL® RHA Deep Lines WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale assessing wrinkle severity with 1 being 'absent' and 5 being 'extreme' TI = Treating Investigator|Baseline and Weeks 2, 4, 12, 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||WSRS Delta from V1||Standard Deviation|Mean
2597671|NCT02195427|Secondary|Delta of the WSRS Score Between W24,36,52 and Baseline for TEOSYAL® RHA GA Versus Juvéderm® Ultra XC and TEOSYAL® RHA DL Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the WSRS Score Assessed by the BLE|TEOSYAL® RHA GA = TEOSYAL® RHA Global Action TEOSYAL® RHA DL = TEOSYAL® RHA Deep Lines WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale assessing wrinkle severity with 1 being 'absent' and 5 being 'extreme' BLE = Blinded Live Evaluator|Baseline and Weeks 24, 36, 52, 64|Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)|||WSRS Delta from V1||Standard Deviation|Mean
2597672|NCT02195427|Secondary|Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).|VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain|During Injection and 5, 15, 30 minutes post-injection|"1 subject randomized to the GA/J cohort received injections with DL/J and was placed in the DL/J cohort for safety evaluation; So: N=75 for DL/J SAFT population and N=72 for GA/J SAFT population.~Number of patients after touch-up treatment are based on number of patients receiving Touch-up treatment (GA N=47/J-GA N=49/DL N=50/J-DL N=53)"|||VAS score||Standard Deviation|Mean
2597673|NCT02195427|Secondary|Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Global Action (GA) and TEOSYAL® RHA Deep Lines (DL) Versus Juvéderm® Ultra XC (J).|"The subjects received a diary booklet and instructions for recording his/her observations of the Common Treatment Responses of the study treatments for the first 14 days after each treatment (initial, touch-up). The diary was discussed during each telephone follow-up visit. Subjects should complete the diary at approximately the same time each day (i.e., am or pm).~The subject diary captured the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and other.~The 14-day patient CTR diary included a detailed glossary describing all signs/symptoms listed in the diary; an option was provided to rate other if the subject experienced a sign/symptom that is not listed.~The table presents the number of subjects experiencing at least 1 Common Treatment Response (CTR)"|During 14 days after initial treatment (D0) and touch-up (2 weeks)|"1 subject randomized to the GA/J cohort received injections with DL/J and was placed in the DL/J cohort for safety evaluation; So: N=75 for DL/J SAFT population and N=72 for GA/J SAFT population.~Number of patients for CTR after touch-up treatment are based on number of patients receiving Touch-up treatment (GA N=47/J-GA N=49/DL N=50/J-DL N=53)"|||Participants|||Count of Participants
2597674|NCT02195427|Primary|Non-inferiority of the Delta of TEOSYAL® RHA GA and TEOSYAL® RHA DL Versus Juvéderm® Ultra XC for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE).|TEOSYAL® RHA GA = TEOSYAL® RHA Global Action TEOSYAL® RHA DL = TEOSYAL® RHA Deep Lines WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale assessing wrinkle severity with 1 being 'absent' and 5 being 'extreme' BLE = Blinded Live Evaluator|Baseline and 24 weeks after last treatment||||units on a scale||97.5% Confidence Interval|Mean
2597675|NCT02195414|Secondary|MSCT Endpoint||3 years||2018-10-31|10/2018||||
2597676|NCT02195414|Secondary|MSCT Endpoint|mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area|1 year||2016-10-31|10/2016||||
2597677|NCT02195414|Secondary|IVUS Endpoint||5 years||2020-10-31|10/2020||||
2597678|NCT02195414|Secondary|IVUS Endpoint||2 years||2017-10-31|10/2017||||
2597679|NCT02195414|Secondary|IVUS Endpoint|mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area|6 months||2016-04-30|04/2016||||
2597692|NCT02195414|Secondary|Scaffold Thrombosis|"Scaffold thrombosis will be categorized as acute (≤1day), subacute (>1day ≤30 days) and late (>30 days).~Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion).~In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the targetlesion within 30 days."|30days||||participants|||Number
2597693|NCT02195414|Secondary|Acute Success (Clinical Device and Clinical Procedure)|"Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable).~Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In dual lesion setting both lesions must meet clinical procedure success."|acute||||participants|||Number
2597694|NCT02195414|Secondary|Patient Oriented Composite Endpoint||5 years||2019-10-31|10/2019||||
2597695|NCT02195414|Secondary|Patient Oriented Composite Endpoint||4 years||2018-10-31|10/2018||||
2597696|NCT02195414|Secondary|Patient Oriented Composite Endpoint||3 years||2017-10-31|10/2017||||
2597697|NCT02195414|Secondary|Patient Oriented Composite Endpoint||2 years||2016-10-31|10/2016||||
2597698|NCT02195414|Secondary|Patient Oriented Composite Endpoint||1 year||2016-10-31|10/2016||||
2597699|NCT02195414|Secondary|Patient Oriented Composite Endpoint|Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.|6 months||2016-04-30|04/2016||||
2597700|NCT02195414|Secondary|Patient Oriented Composite Endpoint|Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.|30 days||||participants|||Number
2597701|NCT02195414|Secondary|Target Lesion Failure||5 years||2020-10-31|10/2020||||
2597702|NCT02195414|Secondary|Target Lesion Failure||4 years||2019-10-31|10/2019||||
2597703|NCT02195414|Secondary|Target Lesion Failure||3 years||2018-10-31|10/2018||||
2597704|NCT02195414|Secondary|Target Lesion Failure||2 years||2017-10-31|10/2017||||
2597705|NCT02195414|Secondary|Target Lesion Failure||1 year||2016-10-31|10/2016||||
2597706|NCT02195414|Secondary|Target Lesion Failure|Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.|6 months||2016-04-30|04/2016||||
2597707|NCT02195414|Primary|Target Lesion Failure(TLF)|Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.|30 days||||participants|||Number
2597708|NCT02195349|Secondary|Percentage of Participants in Each PGA Score Category|A 7-point scoring system was used to measure the severity of psoriatic lesions over the whole body. The score 0=clear, 1=almost clear, 2=mild, 3=mild to moderate, 4=moderate, 5=moderate to severe and 6=severe.|Baseline, Days 15, 29, 43, 85 and 121|Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Percentage of participants|||Number
2597709|NCT02195349|Secondary|Absolute PGA Scores in Psoriasis Participants|A 7-point scoring system was used to measure the severity of psoriatic lesions over the whole body. The score 0 indicated as clear: no signs of psoriasis and 6 indicated as severe: very marked plaque elevation, scaling and erythema.|Baseline, Days 15, 29, 43, 85 and 121|Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2597710|NCT02195349|Secondary|Change From Baseline in Physicians Global Assessment (PGA) Scores in Psoriasis Participants|A 7-point scoring system was used to measure the severity of psoriatic lesions over the whole body. The score 0 indicated as clear: no signs of psoriasis and 6 indicated as severe: very marked plaque elevation, scaling and erythema. Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline, Days 15, 29, 43, 85 and 121|Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2597711|NCT02195349|Secondary|Absolute PLSS Scores for the Index Plaque|PLSS is a 0 to 12 point rating scale for lesions, calculated as the sum of the scores (ranging from 0 = no symptoms to 4 = very marked) for 3 symptoms: induration, erythema and scaling, measured by a qualified dermatologist. The PLSS score for the Index Plaque ranged from 0 to 12. The score 0 indicated no symptoms and 12 is the worst score.|Baseline, Days 15, 29, 43, 85 and 121|Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2597712|NCT02195349|Secondary|Change From Baseline in Plaque Lesional Severity Score (PLSS) Scores for the Index Plaque|PLSS is a 0 to 12 point rating scale for lesions, calculated as the sum of the scores (ranging from 0 = no symptoms to 4 = very marked) for 3 symptoms: induration, erythema and scaling, measured by a qualified dermatologist. The PLSS score for the Index Plaque ranged from 0 to 12. The score 0 indicated no symptoms and 12 is the worst score. Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value. A negative change from Baseline is an improvement in symptoms.|Baseline, Days 15, 29, 43, 85 and 121|Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2597726|NCT02195349|Secondary|Number of Participants With Positive ADAs to GSK2831781 in Healthy Volunteer Placebo|Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.|Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 191)|Safety population.|||Participants|||Count of Participants
2598492|NCT02186301|Secondary|Duration of Response|Duration of Response in Patients with Confirmed Response per Investigator|Cycle 1 Day 1 to End of Treatment, up to approximately 35 months||||Days||95% Confidence Interval|Median
2597713|NCT02195349|Secondary|Percentage of Participants Who Achieved >=50 Percent (%) and >=75% Improvement From Baseline in PASI Score|PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head, upper extremities, trunk and lower extremities with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged from 0=No symptoms, 1=slight, 2=moderate, 3=marked and 4=very marked) of erythema, induration and scaling in each of the 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area) * (% body area affected score * area score). Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1.|Baseline, Days 15, 29, 43, 85 and 121|Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Percentage of participants|||Number
2597714|NCT02195349|Secondary|Actual PASI Scores|PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head, upper extremities, trunk and lower extremities with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged from 0=No symptoms, 1=slight, 2=moderate, 3=marked and 4=very marked) of erythema, induration and scaling in each of the 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area) * (% body area affected score * area score).|Baseline, Days 15, 29, 43, 85 and 121|Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2597715|NCT02195349|Secondary|Change From Baseline in Psoriasis Area Severity Index (PASI) Scores|PASI score was determined by evaluation of body surface area (BSA) covered by plaque psoriasis in 4 areas (head, upper extremities, trunk and lower extremities with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged from 0=No symptoms, 1=slight, 2=moderate, 3=marked and 4=very marked) of erythema, induration and scaling in each of the 4 areas. PASI score ranges from 0 (no psoriasis) to 72 (worse psoriasis). Final PASI=(sum of severity score for each area) * (% body area affected score * area score). Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline, Days 15, 29, 43, 85 and 121|Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2597716|NCT02195349|Secondary|Number of Participants With Positive ADAs to GSK2831781 5 mg/kg|Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.|Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 307)|Safety population.|||Participants|||Count of Participants
2597717|NCT02195349|Secondary|Number of Participants With Positive ADAs to GSK2831781 1.5 mg/kg|Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.|Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 277)|Safety population.|||Participants|||Count of Participants
2597718|NCT02195349|Secondary|Number of Participants With Positive ADAs to GSK2831781 0.5 mg/kg|Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.|Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 237)|Safety population.|||Participants|||Count of Participants
2597719|NCT02195349|Secondary|Number of Participants With Positive ADAs to GSK2831781 Placebo in Psoriasis Participants|Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.|Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 307)|Safety population.|||Participants|||Count of Participants
2597720|NCT02195349|Secondary|Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA+ve)|Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.|Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 191)|Safety population.|||Participants|||Count of Participants
2597721|NCT02195349|Secondary|Number of Participants With Positive ADAs to GSK2831781 0.15 mg/kg (ADA-ve)|Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.|Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 219)|Safety population.|||Participants|||Count of Participants
2597722|NCT02195349|Secondary|Number of Participants With Positive ADAs to GSK2831781 0.04 mg/kg (ADA-ve)|Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.|Pre-dose (Day 1), 168 hours, Days 29, 85 and follow-up (Day 147)|Safety population.|||Participants|||Count of Participants
2597723|NCT02195349|Secondary|Number of Participants With Positive ADAs to GSK2831781 0.0075 mg/kg (ADA-ve)|Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.|Pre-dose (Day 1), 168 hours, Days 29 and follow-up (Day 85)|Safety population.|||Participants|||Count of Participants
2597724|NCT02195349|Secondary|Number of Participants With Positive ADAs to GSK2831781 0.0015 mg/kg (ADA-ve)|Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.|Pre-dose (Day 1), 168 hours, Days 29 and follow-up (Day 43)|Safety population.|||Participants|||Count of Participants
2597725|NCT02195349|Secondary|Number of Participants With Positive ADAs to GSK2831781 0.0003 mg/kg (ADA-ve)|Serum samples were collected at indicated time points for determination of ADA. ADAs to GSK2831781 was detected using a validated binding antibody detection.|Pre-dose (Day 1), 168 hours, and follow-up (Day 29)|Safety population.|||Participants|||Count of Participants
2607388|NCT02090426|Other Pre-specified|Any Hospital Use (Inpatient or ED)||365-day from indexed hospital discharge||2021-01-31|01/2021||||
2597728|NCT02195349|Secondary|t1/2 for GSK2831781 1.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose|PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.||||||
2597729|NCT02195349|Secondary|t1/2 for GSK2831781 0.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose|PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.||||||
2597730|NCT02195349|Secondary|t1/2 for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose|PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.||||||
2597731|NCT02195349|Secondary|t1/2 for GSK2831781 0.04 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose|PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.||||||
2597732|NCT02195349|Secondary|t1/2 for GSK2831781 0.0075 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose|PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.||||||
2597733|NCT02195349|Secondary|t1/2 for GSK2831781 0.0015 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.||||||
2597734|NCT02195349|Secondary|Terminal Phase Half-life (t1/2) for GSK2831781 0.0003 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose|PK population. Data were not analyzed for t1/2 as there were not enough data points collected for a terminal slope required to calculate t1/2.||||||
2597735|NCT02195349|Secondary|Lambda z for GSK2831781 5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose|PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.||||||
2597736|NCT02195349|Secondary|Lambda z for GSK2831781 1.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose|PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.||||||
2597737|NCT02195349|Secondary|Lambda z for GSK2831781 0.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose|PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.||||||
2597738|NCT02195349|Secondary|Lambda z for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose|PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.||||||
2597739|NCT02195349|Secondary|Lambda z for GSK2831781 0.04 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose|PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.||||||
2597740|NCT02195349|Secondary|Lambda z for GSK2831781 0.0075 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose|PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.||||||
2597741|NCT02195349|Secondary|Lambda z for GSK2831781 0.0015 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.||||||
2597742|NCT02195349|Secondary|Terminal Elimination Rate (Lambda z) for GSK2831781 0.0003 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose|PK population. Data were not analyzed for lambda z as there were not enough data points collected for a terminal slope required to calculate lambda z.||||||
2597743|NCT02195349|Secondary|MRT for GSK2831781 5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose|PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.||||||
2597744|NCT02195349|Secondary|MRT for GSK2831781 1.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose|PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.||||||
2597745|NCT02195349|Secondary|MRT for GSK2831781 0.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose|PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.||||||
2597746|NCT02195349|Secondary|MRT for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose|PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.||||||
2597747|NCT02195349|Secondary|MRT for GSK2831781 0.04 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose|PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.||||||
2597748|NCT02195349|Secondary|MRT for GSK2831781 0.0075 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose|PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.||||||
2597749|NCT02195349|Secondary|MRT for GSK2831781 0.0015 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.||||||
2597750|NCT02195349|Secondary|Mean Residence Time (MRT) for GSK2831781 0.0003 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose|PK population. Data were not analyzed for MRT as there were not enough data points collected for a terminal slope required to calculate MRT.||||||
2597751|NCT02195349|Secondary|Vss for GSK2831781 5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose|PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.||||||
2597752|NCT02195349|Secondary|Vss for GSK2831781 1.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose|PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.||||||
2597753|NCT02195349|Secondary|Vss for GSK2831781 0.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose|PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.||||||
2597754|NCT02195349|Secondary|Vss for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose|PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.||||||
2597755|NCT02195349|Secondary|Vss for GSK2831781 0.04 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose|PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.||||||
2597756|NCT02195349|Secondary|Vss for GSK2831781 0.0075 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose|PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.||||||
2597757|NCT02195349|Secondary|Vss for GSK2831781 0.0015 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.||||||
2597758|NCT02195349|Secondary|Volume of Distribution at Steady State (Vss) for GSK2831781 0.0003 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose|PK population. Data were not analyzed for Vss as there were not enough data points collected for a terminal slope required to calculate Vss.||||||
2597759|NCT02195349|Secondary|CL for GSK2831781 5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose|PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.||||||
2597760|NCT02195349|Secondary|CL for GSK2831781 1.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose|PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.||||||
2597761|NCT02195349|Secondary|CL for GSK2831781 0.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose|PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.||||||
2597762|NCT02195349|Secondary|CL for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose|PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.||||||
2597763|NCT02195349|Secondary|CL for GSK2831781 0.04 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose|PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.||||||
2597764|NCT02195349|Secondary|CL for GSK2831781 0.0075 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose|PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.||||||
2597765|NCT02195349|Secondary|CL for GSK2831781 0.0015 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.||||||
2597766|NCT02195349|Secondary|Systemic Clearance of Parent Drug (CL) for GSK2831781 0.0003 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose|PK population. Data were not analyzed for CL as there were not enough data points collected for a terminal slope required to calculate CL.||||||
2597767|NCT02195349|Secondary|Tlast for GSK2831781 5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose|PK population.|||Hours||Full Range|Median
2597768|NCT02195349|Secondary|Tlast for GSK2831781 1.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose|PK population.|||Hours||Full Range|Median
2597769|NCT02195349|Secondary|Tlast for GSK2831781 0.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose|PK population.|||Hours||Full Range|Median
2597770|NCT02195349|Secondary|Tlast for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose|PK population.|||Hours||Full Range|Median
2597771|NCT02195349|Secondary|Tlast for GSK2831781 0.04 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose|PK population.|||Hours||Full Range|Median
2597772|NCT02195349|Secondary|Tlast for GSK2831781 0.0075 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose|PK population.|||Hours||Full Range|Median
2597773|NCT02195349|Secondary|Tlast for GSK2831781 0.0015 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|PK population.|||Hours||Full Range|Median
2597774|NCT02195349|Secondary|Time of Last Quantifiable Concentration (Tlast) for GSK2831781 0.0003 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose|PK population. Data was not collected because none of the participants had data evaluable for this measure.||||||
2597775|NCT02195349|Secondary|Tmax for GSK2831781 5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose|PK population.|||Hours||Full Range|Median
2597776|NCT02195349|Secondary|Tmax for GSK2831781 1.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose|PK population.|||Hours||Full Range|Median
2597777|NCT02195349|Secondary|Tmax for GSK2831781 0.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose|PK population.|||Hours||Full Range|Median
2597778|NCT02195349|Secondary|Tmax for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose|PK population.|||Hours||Full Range|Median
2597779|NCT02195349|Secondary|Tmax for GSK2831781 0.04 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose|PK population.|||Hours||Full Range|Median
2597780|NCT02195349|Secondary|Tmax for GSK2831781 0.0075 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose|PK population.|||Hours||Full Range|Median
2597781|NCT02195349|Secondary|Tmax for GSK2831781 0.0015 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|PK population.|||Hours||Full Range|Median
2597782|NCT02195349|Secondary|Time of Occurrence of Cmax (Tmax) for GSK2831781 0.0003 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose|PK population.|||Hours||Full Range|Median
2597783|NCT02195349|Secondary|Cmax for GSK2831781 5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose|PK population.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597784|NCT02195349|Secondary|Cmax for GSK2831781 1.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose|PK population.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597785|NCT02195349|Secondary|Cmax for GSK2831781 0.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose|PK population.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597786|NCT02195349|Secondary|Cmax for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose|PK population.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597787|NCT02195349|Secondary|Cmax for GSK2831781 0.04 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose|PK population.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597788|NCT02195349|Secondary|Cmax for GSK2831781 0.0075 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose|PK population.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597789|NCT02195349|Secondary|Cmax for GSK2831781 0.0015 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|PK population.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597791|NCT02195349|Secondary|%AUCex for GSK2831781 5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose|PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.||||||
2597792|NCT02195349|Secondary|%AUCex for GSK2831781 1.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose|PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.||||||
2597793|NCT02195349|Secondary|%AUCex for GSK2831781 0.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose|PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.||||||
2597794|NCT02195349|Secondary|%AUCex for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose|PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.||||||
2597795|NCT02195349|Secondary|%AUCex for GSK2831781 0.04 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose|PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.||||||
2597796|NCT02195349|Secondary|%AUCex for GSK2831781 0.0075 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose|PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.||||||
2597797|NCT02195349|Secondary|%AUCex for GSK2831781 0.0015 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.||||||
2597798|NCT02195349|Secondary|Percentage of AUC(0-infinity) Obtained by Extrapolation (%AUCex) for GSK2831781 0.0003 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose|PK population. Data were not analyzed for %AUCex as there were not enough data points collected for a terminal slope required to calculate %AUCex.||||||
2597799|NCT02195349|Secondary|AUC(0-Week 4) for GSK2831781 5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose|PK population.|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597800|NCT02195349|Secondary|AUC(0-Week 4) for GSK2831781 1.5 mg/kg|Blood samples were collected at specified time point for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose|PK population.|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597801|NCT02195349|Secondary|AUC(0-Week 4) for GSK2831781 0.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose|PK population.|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597802|NCT02195349|Secondary|AUC(0-Week 4) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22 and 29 (Week 4) post-dose|PK population.|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597803|NCT02195349|Secondary|AUC(0-Week 4) for GSK2831781 0.04 mg/kg (ADA-ve)|Blood samples were collected at specified time point for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22 and 29 (Week 4) post-dose|PK population.|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597804|NCT02195349|Secondary|AUC(0-Week 4) for GSK2831781 0.0075 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15 and 29 (Week 4) post-dose|PK population.|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597805|NCT02195349|Secondary|AUC(0-Week 4) for GSK2831781 0.0015 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 and 696 (Week 4) hours post-dose|PK population.|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597806|NCT02195349|Secondary|Area Under the Concentration-time Curve From Zero (Pre-dose) to Week 4 (AUC[0-Week 4]) for GSK2831781 0.0003 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24 and 696 (Week 4) hours post-dose|PK population. Data was not collected because none of the participants had data evaluable for this measure.||||||
2597807|NCT02195349|Secondary|AUC(0-t) for GSK2831781 5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose|PK population.|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597808|NCT02195349|Secondary|AUC(0-t) for GSK2831781 1.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose|PK population.|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597809|NCT02195349|Secondary|AUC(0-t) for GSK2831781 0.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose|PK population.|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597810|NCT02195349|Secondary|AUC(0-t) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose|PK population.|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2598648|NCT02183792|Other Pre-specified|Weight Change|Difference assessed at baseline, 8, 24, 48, 72 and 96 hours.|Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days|||||||
2597811|NCT02195349|Secondary|AUC(0-t) for GSK2831781 0.04 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose|PK population.|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597812|NCT02195349|Secondary|AUC(0-t) for GSK2831781 0.0075 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose|PK population.|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597813|NCT02195349|Secondary|AUC(0-t) for GSK2831781 0.0015 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|PK population.|||h*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2597814|NCT02195349|Secondary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t]) for GSK2831781 0.0003 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose|PK population. Data was not collected because none of the participants had data evaluable for this measure.||||||
2597815|NCT02195349|Secondary|AUC(0-infinity) for GSK2831781 5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 43, 57, 71, 85 and 121 post-dose|PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).||||||
2597816|NCT02195349|Secondary|AUC(0-infinity) for GSK2831781 1.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 29, 36, 43, 57, 85 and 121 post-dose|PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).||||||
2597817|NCT02195349|Secondary|AUC(0-infinity) for GSK2831781 0.5 mg/kg|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43, 85 and 121 post-dose|PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).||||||
2597818|NCT02195349|Secondary|AUC(0-infinity) for GSK2831781 0.15 mg/kg (ADA-ve) and (ADA+ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 11, 15, 18, 22, 43 and 85 post-dose|PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).||||||
2597819|NCT02195349|Secondary|AUC(0-infinity) for GSK2831781 0.04 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8, 15, 22, 29, 43 and 57 post-dose|PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).||||||
2597820|NCT02195349|Secondary|AUC(0-infinity) for GSK2831781 0.0075 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours, Days 8 and 15 post-dose|PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).||||||
2597821|NCT02195349|Secondary|AUC(0-infinity) for GSK2831781 0.0015 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma.|Pre-dose, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose|PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).||||||
2597822|NCT02195349|Secondary|Area Under the Plasma Time Curve From Zero to Infinity (AUC[0-infinity]) of GSK2831781 0.0003 mg/kg (ADA-ve)|Blood samples were collected at specified time points for GSK2831781 in plasma. Pharmacokinetic (PK) population consisted of all participants in the Safety Population who had at least 1 non-missing PK assessment.|Pre-dose, 1, 2, 4, 6, 8, 12 and 24 hours post-dose|PK population. Data were not analyzed for AUC(0-infinity) as there were not enough data points collected for a terminal slope required to calculate AUC(0-infinity).||||||
2597823|NCT02195349|Secondary|Change From Baseline in LAG-3+ Cells in Lesional Biopsies in Psoriasis Participants at Day 29|A punch biopsy was taken from active leading edge of the lesion. Cells in lesional biopsies of skin were measured by IHC and count the LAG-3+ cells. The regions of interest for LAG3+ were located in epidermis and dermis. Baseline was considered as the latest pre-dose assessment with a non-missing value for Day -1. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline and Day 29|Safety population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||LAG3+ cells||Standard Deviation|Mean
2597824|NCT02195349|Secondary|Change From Baseline (PPD First Challenge) of Lymphocyte Activation Gene-3 (LAG-3)+ Cells in Biopsies of Re-challenged Skin at 3 Days Post-dose|A punch biopsy was taken from one of the challenge sites. Cells in biopsies of re-challenged skin were measured by immunohistochemistry (IHC) and the LAG-3+ cells characterized and counted. Baseline was considered as Day -26 for this outcome measure. Change from Baseline was calculated as post-Baseline value minus Baseline value. Data is presented for DTH participants.|Baseline and 72 hours post-dose|Safety population.|||LAG3+ cells||Standard Deviation|Mean
2597825|NCT02195349|Secondary|Duration of Induration in the Re-challenge for DTH|The duration of induration was the time (in days) to achieve an overall induration less than 6 mm from the time of the PPD re-challenge post-dose. Duration of induration was calculated as: PPD re-challenge post-dose up to the last available induration measurement. Data is presented for DTH participants.|Up to 28 days post-dose|Safety population.|||Days||Full Range|Median
2597840|NCT02195349|Primary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) of PCI|Triplicate ECG was measured in a semi-supine position after 5 minutes rest. A single 12-lead ECG was obtained by using an ECG machine that automatically calculates heart rate and measured PR, QRS, QT, and Fridericia's formula (QTcF) intervals. The PCI ranges for QTc Interval (high: >450 millisecond [msec]), PR Interval (low: <110 msec and high: >220 msec) and QRS Interval (low: <75 msec and high: >110 msec). Number of participants with ECG values of PCI are presented.|Up to 307 days|Safety population.|||Participants|||Count of Participants
2597826|NCT02195349|Secondary|Change From Baseline (PPD First Challenge) of Induration Diameter From Re-challenge at 3 Days Post-dose|The induration diameter by challenge site is defined as the average of the two skin response test values (vertical and horizontal) at each challenge site. A challenge site is defined by skin response (SR) directionality (upper/lower) and SR laterality (left/right). Four categories considered were as follows: left upper, right upper, left lower and right lower. Baseline was considered as Day -26. Change from Baseline was calculated as post-Baseline value minus Baseline value. Data is presented for DTH participants.|Baseline, Days 4, 8, 15 and 22 post-dose|Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Millimeter (mm)||Standard Deviation|Mean
2597827|NCT02195349|Primary|Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 5 mg/kg|Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.|6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 307|Safety population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2597828|NCT02195349|Primary|Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 1.5 mg/kg|Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.|6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 277|Safety population.|||Participants|||Count of Participants
2597829|NCT02195349|Primary|Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.5 mg/kg|Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.|6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 237|Safety population.|||Participants|||Count of Participants
2597830|NCT02195349|Primary|Number of Participants With Abnormal Values on Urinalysis by Dipstick for Psoriasis Placebo|Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.|6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 307|Safety population.|||Participants|||Count of Participants
2597831|NCT02195349|Primary|Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA+ve)|Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.|6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 191|Safety population.|||Participants|||Count of Participants
2597832|NCT02195349|Primary|Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.15 mg/kg (ADA-ve)|Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.|6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 219|Safety population.|||Participants|||Count of Participants
2608787|NCT02074059|Primary|Oxygen Saturation Levels|Oxygen saturation as determined by pulse oximetry|Within 3 Hours of Randomization|Safety Population|||percentage of oxygen saturation||Standard Deviation|Mean
2597833|NCT02195349|Primary|Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.04 mg/kg (ADA-ve)|Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.|6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 147|Safety population.|||Participants|||Count of Participants
2597834|NCT02195349|Primary|Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0075 mg/kg (ADA-ve)|Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.|6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57 and 85|Safety population.|||Participants|||Count of Participants
2597835|NCT02195349|Primary|Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0015 mg/kg (ADA-ve)|Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.|6, 12, 72, 168 hours, Days 15, 29 and 43|Safety population.|||Participants|||Count of Participants
2597836|NCT02195349|Primary|Number of Participants With Abnormal Values on Urinalysis by Dipstick for GSK2831781 0.0003 mg/kg (ADA-ve)|Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.|6, 12, 72, 168 hours, Day 15 and 29|Safety population.|||Participants|||Count of Participants
2597837|NCT02195349|Primary|Number of Participants With Abnormal Values on Urinalysis by Dipstick in Placebo Healthy Volunteers|Urine samples were collected at indicated time points to analyze parameters including glucose, protein, blood, leucocytes, nitrites and ketones by dipstick. Urine dipstick tests were either read as qualitative concentrations as Negative, Trace, 1+ (low concentrations present), 2+ (moderate concentrations present), 3+ (high concentrations present) and 4+ (very high concentrations present); or as semi quantitative cell counts or concentrations (0, 0.25, 0.5, 1.5,5, 7, 9, 10, 25, 50, 150, 250) where units depend on the test performed; (cells/micro liter for blood and leucocytes; mmol/L for glucose and ketones; g/L for protein), and Negative (not detected) or Positive (detected) for nitrites. For each methodology, abnormal results were defined as those that were not 'Negative' or 'Trace'. Only categories with abnormal urinalysis values are presented.|6, 12, 72, 168 hours, Days 15, 22, 29, 43, 57, 85, 121 and 191|Safety population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2597838|NCT02195349|Primary|Change From Baseline in Interleukin (IL)-6, IL-8, Interferon-gamma, and Tumor Necrosis Factor (TNF) Alpha|IL-6, IL-8, interferon-gamma and TNF alpha were assessed at indicated time points. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day 1, pre-dose). Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline, 6, 12, 24 and 48 hours post-dose|Safety population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Picogram per milliliter (pg/mL)||Standard Deviation|Mean
2597839|NCT02195349|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product whether or not considered related to the study treatment. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect and other important medical events judged by the investigator that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|Up to 307 days|Safety population.|||Participants|||Count of Participants
2597911|NCT02194621|Primary|Anaerobic Bacteria|Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.|Baseline||||colony forming units||Standard Deviation|Mean
2608788|NCT02074059|Primary|All Cause Mortality||Within 36 Weeks PMA|Safety Population|||participants|||Number
2597841|NCT02195349|Primary|Number of Participants With Vital Signs of PCI|Vital signs included heart rate, systolic and diastolic blood pressure and body temperature were performed with the participant in a semi-supine position after the participant had rested for at least 5 minutes. The PCI range for heart rate (low: <40 beats per minute [BPM] and high: >110 BPM), systolic blood pressure (low: <85 and high: >160 millimeter of mercury [mmHg]), diastolic blood pressure (low: <45 mmHg and high: >100 mmHg) and body temperature (low: <35 degree Celsius and high: >37.5 degree Celsius). Number of participants with vital signs of PCI are presented.|Up to 307 days|Safety population.|||Participants|||Count of Participants
2597842|NCT02195349|Primary|Number of Participants With Clinical Chemistry Abnormalities of PCI|Clinical chemistry parameters and their potential clinical concern values: albumin (low: <30 millimoles per liter [mmol/L]), calcium (low: <2 mmol/L, high: >2.75 mmol/L), creatinine (high: >44.2 mmol/L), glucose (low: <3 mmol/L, high: >9 mmol/L), magnesium (low: <0.5 mmol/L, high: >1.23 mmol/L), phosphorus (low: <0.8 mmol/L, high: >1.6 mmol/L), potassium (low: <3 mmol/L, high: >5.5 mmol/L), sodium (low: <130 mmol/L, high: >150 mmol/L), and total carbon dioxide (CO2) (low: <18 mmol/L, high: >32 mmol/L). Number of participants with clinical chemistry of PCI are presented.|Up to 307 days|Safety population.|||Participants|||Count of Participants
2597843|NCT02195349|Primary|Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI)|Hematology parameters with PCI ranges: hematocrit (high: >0.54 percentage of red blood cells), hemoglobin (high: >180 grams per liter [g/L]), lymphocytes (low: <0.8*giga cells per liter [10^9/L]), neutrophil count (low: <1.5*10^9/L), platelet count (low: <100*10^9/L and high: >550*10^9/L), and while blood cell count (low: <3*10^9/L and high: >20*10^9/L) for healthy volunteers and psoriasis participants. Safety population consisted of all randomized participants who received at least one dose of study treatment. Only those participants for which at least one value of PCI was reported are summarized.|Up to 307 days|Safety population.|||Participants|||Count of Participants
2597844|NCT02195310|Primary|Surgical Site Infection (SSI) Rate Within 34 Days Postoperatively, Defined as Superficial, Deep, and Organ/Space Infections as Per CDC Guidelines.|"The SSI rate (in %) was calculated for each treatment arm as follows:~SSI rate = [Number of Subjects who experienced SSI] / [Number of Subjects Analyzed] * 100 Subjects included in the numerator for the SSI rate computation must have experienced an SSI post-surgery up to Day 30 (± 4 days). If a subject has the same SSI event on multiple occasions or experiences several events of other SSIs, the subject will be counted only once in the numerator for the first event"|30 ± 4 days|Full Analysis Set: Included Subjects in the ITT Analysis Set that had no important disqualifying protocol deviations, who met the inclusion/exclusion criteria, and had completed SSI evaluations at visit 5 (Follow-up Day 30). Subjects were analyzed in the arm to which they were treated.|||percentage of SSI|||Number
2597845|NCT02195232|Secondary|Cumulative Incidence of VTE at 56 Days|To investigate the cumulative incidence of VTE according to tissue factor bearing microparticle status (and isoquercetin randomization).|56 days|All patients who began assigned treatment were analyzed.|||participants|||Number
2597846|NCT02195232|Secondary|Number of Participants With Hemorrhage|Investigating the safety of isoquercetin in cancer patients|study visits until day 56||||Participants|||Count of Participants
2597847|NCT02195232|Primary|Percent Change in D-dimer Value|D-dimer concentrations will be compared for each patient at day 0 and day 56 by a paired-t test analysis. Analysis will be performed on an intention to treat basis for patients who undergo randomization and completed the baseline and day 56 D-dimer assessments.|Baseline, 56 Day|The analysis data set is comprised of evaluable patients.|||percent change||Full Range|Median
2597848|NCT02195011|Secondary|Median Overall Survival|Defined as the time (in months) from date of randomization to date of death from any cause, or censored at the date last known alive.|up to 18 months|Includes all patients who received treatment.|||Months||95% Confidence Interval|Median
2597849|NCT02195011|Secondary|Median Progression-Free Survival|Defined as the time (in months) from date of randomization to the date of first observation of progression based on radiological assessment by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, or date of death from any cause, in the absence of progressive disease (PD) or censored at the date of last adequate tumor assessment. Progressive Disease is defined by RECIST v1.1 as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum while on study (this includes the baseline sum if that is the smallest on study), or the appearance of one or more new lesions.|At 6 and 12 weeks after SIR-Spheres, and every 8 weeks thereafter, up to 18 months.|Includes all patients who received treatment.|||months||95% Confidence Interval|Median
2597850|NCT02195011|Secondary|Number of Patients With an Objective Response (CR or PR)|Defined as the number of patients with objective evidence of complete or partial response (CR or PR) using RECIST v 1.1. A CR is the complete disappearance of all target lesions. A PR is a decrease in of 30% or more of the diameter(s) of all target lesions from the baseline sum of diameters.|At 6 and 12 weeks after SIR-Spheres, and every 8 weeks thereafter, up to 18 months|Includes all patients who have received study treatment.|||Participants|||Count of Participants
2597851|NCT02195011|Primary|The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of Safety|A treatment-related adverse event or serious adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator's assessment). Adverse events and serious adverse events will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V4.03.|up to 15 months|All patients who receive at least one dose of treatment.|||Participants|||Count of Participants
2597863|NCT02194998|Primary|Number of Participants Who Prematurely Discontinued HCV Study Treatment for Any Reason Other Than HCV Virologic Failure (VF)|HCV VF was defined as follows: confirmed increase from nadir in HCV RNA (defined as two consecutive HCV RNA measurements of >1 log10 IU/mL above nadir) at any time point; failure to achieve HCV RNA <LLOQ (<15 IU/mL) by week 6; confirmed HCV RNA ≥LLOQ (defined as two consecutive HCV RNA measurements ≥LLOQ (≥15 IU/mL)) at any point after HCV RNA <LLOQ during HCV treatment|From treatment initiation to either 24 weeks (for Cohort A and C) or 12 weeks (for Cohort B and D). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.|Participants who initiated study treatment.|||Participants|||Count of Participants
2598654|NCT02183792|Secondary|Median Change in Serum Creatinine at 24 Hours Post Randomization|Comparison between baseline and 24 hours post randomization concentrations.|24 hours post randomization||||mg/dL||Inter-Quartile Range|Median
2597852|NCT02194998|Secondary|Percentage of Participants With Sustained Virologic Response at 24 Weeks After HCV Treatment Discontinuation (SVR24)|"SVR24 was defined as HCV RNA less than the assay LLOQ (<15 IU/mL) at 24 weeks post treatment discontinuation.~A two-sided 90% confidence interval was calculated for the percentage of SVR24 response using method of Clopper-Pearson.~For those whose HCV early responses prior to SVR24 evaluation met the guidelines for HCV VF, their SVR24 outcome was defined as non-response. Those missing a HCV RNA result from the week 24 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 24 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 24 post treatment discontinuation was instead used to define the primary outcome."|At 24 weeks after the date of last dose of HCV study treatment. The duration for study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.|Participants who initiated study treatment.|||percentage of participants||90% Confidence Interval|Number
2597853|NCT02194998|Secondary|Number of Participants With HCV Mutations Conferring Resistance to Any Component of the HCV Treatment Regimen|Study team decided to remove this secondary outcome measure due to reduced interest in study treatment as a result of development and approval of newer DAA's.|From treatment initiation to 12 weeks post date of last dose of HCV study treatment. The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.|No participants are included in this analysis. The outcome measure was withdrawn and no specimen testing was performed.||||||
2597854|NCT02194998|Secondary|Change in IP-10 Concentration.|Absolute change from baseline in IP-10 (Interferon gamma-induced protein 10) concentration in plasma, calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose.|At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.|All participants who initiated treatment and had available data at baseline and the respective post-baseline visit.|||pg/mL||Inter-Quartile Range|Median
2597855|NCT02194998|Secondary|Levels of IP-10 Concentration.|Levels of IP-10 (Interferon gamma-induced protein 10) concentration in plasma. Baseline was defined as the date of first treatment dose.|At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.|All participants who initiated treatment and had available data at the study visit.|||pg/mL||Inter-Quartile Range|Median
2597856|NCT02194998|Secondary|Change in Soluble CD14 (sCD14)|Absolute change from baseline in sCD14 levels in plasma calculated as value at the later time point minus baseline value. Baseline was defined as the date of first treatment dose.|At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.|All participants who initiated treatment and had available data at baseline and the respective post-baseline visit.|||ng/mL||Inter-Quartile Range|Median
2597857|NCT02194998|Secondary|Levels of Soluble CD14 (sCD14)|Levels of sCD14. Baseline was defined as the date of first treatment dose.|At baseline, end of HCV treatment (EOT), and 12 weeks post EOT. The EOT for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.|All participants who initiated treatment and had available data at the study visit.|||ng/mL||Inter-Quartile Range|Median
2597858|NCT02194998|Secondary|Number of Participants With Selected HIV-1 Resistance Mutations Among Participants Who Experience HIV-1 Virologic Failure (VF)|Participants with one or more genotype mutations in protease conferring major resistance to any HIV-1 Protease Inhibitors (PI) antiretroviral drug, from a plasma sample drawn following confirmed HIV-1 VF outcome.|At confirmation of HIV-1 virologic failure.|Participants who experienced confirmed HIV-1 virologic failure (a single participant from Cohort D [PI-based + (3 DAA: 12 wks)]).|||Participants|||Count of Participants
2597859|NCT02194998|Secondary|Number of Participants Who Experienced HIV-1 Virologic Failure (VF)|HIV-1 VF was defined as two consecutive HIV-1 RNA results ≥ 200 copies/mL.|From treatment initiation to 4 weeks after last dose of HCV study treatment. HIV-1 RNA was measured at weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28. The durations for HCV study treatment for Cohorts A/C and Cohorts B/D were 24 and 12 weeks, respectively.|Participants who initiated study treatment.|||Participants|||Count of Participants
2597860|NCT02194998|Primary|Number of Participants With an Occurrence of Laboratory Abnormality Grade 3 or Higher.|"Participants with an observed laboratory abnormalities grade 3 or higher post treatment initiation.~If entry (pre-treatment) lab result was grade 3, then a grade 4 result was required to meet this outcome.~Severity grading was based on DAIDS AE Grading Table, Version 1.0."|From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.|Participants who initiated study treatment.|||Participants|||Count of Participants
2597861|NCT02194998|Primary|Number of Participants With an Occurrence of Diagnoses Leading to Premature HCV Study Treatment or HIV-1 Antiretroviral (ARV) Discontinuation.|Participants who had diagnoses leading to premature HCV study treatment or HIV-1 ARV discontinuation post treatment initiation.|From treatment initiation to end of study follow-up at 48 weeks.The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively. The duration for ARV treatment for all cohorts was 48 weeks.|Participants who initiated study treatment.|||Participants|||Count of Participants
2597862|NCT02194998|Primary|Number of Participants With an Occurrence of Signs/Symptoms Grade 3 or Higher|"Participants with signs/symptoms of grade 3 or higher post treatment initiation.~Participants with grade 3 sign/symptom prior to treatment initiation must have had one grade higher than pre-treatment to meet this outcome.~Severity grading was based on DAIDS AE Grading Table, Version 1.0."|From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.|Participants who initiated study treatment.|||Participants|||Count of Participants
2597908|NCT02194621|Primary|Malodor Bacteria (Breath Odor Causing Bacteria)|Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.|12 hours||||colony forming units||Standard Error|Mean
2598655|NCT02183792|Primary|Median Urine Output at 24 Hours Post Randomization||24 hours post randomization||||mL||Inter-Quartile Range|Median
2597864|NCT02194998|Primary|Number of Participants With an Occurrence of Serious Adverse Events (SAEs) as Defined by International Conference on Harmonisation (ICH) Criteria|Participants who experienced at least one observed SAEs as defined by ICH after initiating HCV study treatment through 30 days post date of last dose of HCV study treatment.|From treatment initiation to 30 days post date of last dose of HCV study treatment (whether planned or premature discontinuation). The duration for HCV study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.|Participants who initiated study treatment.|||Participants|||Count of Participants
2597865|NCT02194998|Primary|Percentage of Participants With Sustained Virologic Response at 12 Weeks After HCV Treatment Discontinuation (SVR12)|"SVR12 was defined as HCV RNA less than the assay LLOQ (<15 IU/mL) at 12 weeks post HCV treatment discontinuation.~A two-sided 90% confidence interval was calculated for the percentage of participants with SVR12 response using Clopper-Pearson method.~For those whose HCV early responses prior to SVR12 evaluation met the guidelines for HCV Virologic Failure (VF), their SVR12 outcome was defined as non-response. Those missing a HCV RNA result from the week 12 post HCV treatment discontinuation visit (and missing all subsequent evaluations) were considered non-responders. However, if HCV RNA evaluations subsequent to week 12 post treatment discontinuation were non-missing, then the first HCV RNA subsequent to week 12 post treatment discontinuation was instead used to define the primary outcome."|At 12 weeks after last dose of HCV study treatment. The duration for study treatment for Cohorts A and C and Cohorts B and D was 24 and 12 weeks, respectively.|Participants who initiated study treatment.|||percentage of participants||90% Confidence Interval|Number
2597866|NCT02194933|Secondary|Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP)|A validated clinician-rated scale that measured personal and social functioning in 4 domains: socially useful activities (eg, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment was rated as absent, mild, manifest, marked, severe, or very severe and were converted to a total score on a 100-point scale: 71 to 100 - mild functional difficulty, 31 to 70 - manifest disabilities of various degrees and 1 to 30 - minimal functioning that required intense support and/or supervision.|During trial visits from Day 0 to Week 6 (Day 42).|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment|||units on a scale||Standard Error|Least Squares Mean
2597867|NCT02194933|Secondary|CGI-I Score at Week 3|To assess whether the total improvement was entirely due to drug treatment. The rater or investigator's response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared to the participant's condition at baseline (last available measurement at the baseline/Day 0 visit before the first dose of IMP).|During trial visits from Day 0 to Week 3 (Day 21).|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
2597868|NCT02194933|Secondary|Clinical Global Impression - Improvement Scale (CGI-I) Score at Week 6|To assess whether the total improvement was entirely due to drug treatment. The rater or investigator's response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared to the participant's condition at baseline (last available measurement at the baseline/Day 0 visit before the first dose of IMP).|During trial visits from Day 0 to Week 6 (Day 42).|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
2597869|NCT02194933|Secondary|Change From Baseline to Week 3 in CGI-S Score|The severity of illness for each participant was assessed. The rater or investigator's response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|During trial visits from Day 0 to Week 3 (Day 21).|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2597870|NCT02194933|Secondary|Change From Baseline to Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score|The severity of illness for each participant was assessed. The rater or investigator's response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.|During trial visits from Day 0 to Week 6 (Day 42).|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2597871|NCT02194933|Secondary|Change From Baseline to Week 3 in PANSS Negative Subscale Score|PANSS consisted of negative subscale with 7 symptom constructs (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking). Each item was scored using a scale of 1 to 7 (a higher score indicated increased severity). The maximum subscale score was 49; 7 indicated no symptoms; 49 indicated extreme severity.|During trial visits from Day 0 to Week 3 (Day 21).|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2597872|NCT02194933|Secondary|Change From Baseline to Week 6 in PANSS Negative Subscale Score|PANSS consisted of negative subscale with 7 symptom constructs (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking). Each item was scored using a scale of 1 to 7 (a higher score indicated increased severity). The maximum subscale score was 49; 7 indicated no symptoms; 49 indicated extreme severity.|During trial visits from Day 0 to Week 6 (Day 42).|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment|||units on a scale||Standard Error|Least Squares Mean
2597957|NCT02193178|Primary|Anterior Ocular Health - Bulbar and Limbal Redness|Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection|Baseline and 2 weeks||||units on a scale|eyes|Standard Deviation|Mean
2597873|NCT02194933|Secondary|Change From Baseline to Week 3 in PANSS Positive Subscale Score|PANSS consisted of positive subscales with 7 symptom constructs (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). Each item was scored using a scale of 1 to 7 (a higher score indicated increased severity). The maximum subscale score was 49; 7 indicated no symptoms; 49 indicated extreme severity.|During trial visits from Day 0 to Week 3 (Day 21).|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2597874|NCT02194933|Secondary|Change From Baseline to Week 6 in PANSS Positive Subscale Score|PANSS consisted of positive subscales with 7 symptom constructs (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). Each item was scored using a scale of 1 to 7 (a higher score indicated increased severity). The maximum subscale score was 49; 7 indicated no symptoms; 49 indicated extreme severity.|During trial visits from Day 0 to Week 6 (Day 42).|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2597875|NCT02194933|Secondary|Change From Baseline to Week 3 in PANSS Total Score|The PANSS consisted of 3 subscales containing 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. PANSS Positive and Negative subscale scores symptom constructs consisted of positive subscale (7 positive symptom constructs), negative subscale (7 negative symptom constructs), and general psychopathology subscale (16 symptom constructs). The possible maximum PANSS total score was 210; 30 indicating no symptoms; 210 indicating extremely severe symptoms.|During trial visits from Day 0 to Week 3 (Day 21).|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment|||units on a scale||Standard Error|Least Squares Mean
2597876|NCT02194933|Secondary|Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS consisted of 3 subscales containing 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. PANSS Positive and Negative subscale scores symptom constructs consisted of positive subscale (7 positive symptom constructs), negative subscale (7 negative symptom constructs), and general psychopathology subscale (16 symptom constructs). The possible maximum PANSS total score was 210; 30 indicating no symptoms; 210 indicating extremely severe symptoms.|During trial visits from Day 0 to Week 6 (Day 42).|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment|||units on a scale||Standard Error|Least Squares Mean
2597877|NCT02194933|Secondary|Change From Baseline to Week 3 in CPT Behavior|"The AX trials were target trials with a valid cue followed by a valid probe X. This feature was intended to encourage participants to expect a valid probe to follow a valid cue. A consequence of this manipulation was that participants developed a prepotency to respond with target responses on trials for which valid cues were presented. The cue was presented for 1000msec, the inter-stimulus interval was 2000msec, and the target was presented for 500msec with a response window of 1500msec. The ITI was 1200msec. Participants had to practice until criteria were obtained. In the AX‐CPT task, the subjects were instructed to press the Yes button every time there is a blue letter 'X' (target) following a white letter 'A' (cue). During this task, any letter appears on the screen randomly. The value calculated was the rate of correct response for all the reaction of target trial."|During trial visits from Day 0 to Week 3 (Day 21).|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment.|||Rate of correct response||Standard Error|Least Squares Mean
2597878|NCT02194933|Secondary|Change From Baseline to Week 6 in Continuous Performance Task (CPT) Behavior|"The AX trials were target trials with a valid cue followed by a valid probe X. This feature was intended to encourage participants to expect a valid probe to follow a valid cue. A consequence of this manipulation was that participants developed a prepotency to respond with target responses on trials for which valid cues were presented. The cue was presented for 1000msec, the inter-stimulus interval was 2000msec, and the target was presented for 500msec with a response window of 1500msec. The ITI was 1200msec. Participants had to practice until criteria were obtained. In the AX‐CPT task, the subjects were instructed to press the Yes button every time there is a blue letter 'X' (target) following a white letter 'A' (cue). During this task, any letter appears on the screen randomly. The value calculated was the rate of correct response for all the reaction of target trial."|During trial visits from Day 0 to Week 6 (Day 42).|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment|||Rate of correct response||Standard Error|Least Squares Mean
2597879|NCT02194933|Secondary|Change From Baseline to Week 3 in SSRT Task Behavior|Brexpiprazole reduced impulsivity was measured by a change in Stop Signal Reaction Time (SSRT) on the SSRT task (a lower SSRT was suggestive of better inhibition). A white circle was shown for 500ms, followed by a left (<)/right (>) arrow. When an arrow was presented, participants responded as fast as possible with their index/middle finger. A titration procedure with 4 staircases started with stop signal delay (SSD) values of 100, 150, 200 & 250ms to determine participant's SSRT. The tasks included 3 runs with 166 repetition times (TRs), TR=2s; 5 minutes, 32 seconds/run; 96 go trials, 32 stop trials/ run. The total task duration was 16 minutes & 36 seconds. During scanning, the SSD was dynamically adjusted to yield a 50% successful inhibition rate, so that SSRT could be estimated for each participant. This resulted in approximately equal proportions of stop trials with & without a response|During trial visits from Day 0 to Week 3 (Day 21).|All participants who had a valid baseline and a valid Week 3 fMRI scan assessment|||Millisecond||Standard Deviation|Median
2597909|NCT02194621|Primary|Malodor Bacteria (Breath Odor Causing Bacteria)|Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.|Baseline||||colony forming units||Standard Deviation|Mean
2608989|NCT02071290|Primary|ROTEM EXTEM CT|Change in ROTEM parameter Clotting Time (CT) over 24 hours from Admission|0 (Admission), 1, 3, 24 hours||||Seconds||Inter-Quartile Range|Median
2597880|NCT02194933|Secondary|Change From Baseline to Week 6 in Stop Signal Reaction Time Task (SSRT) Task Behavior|Brexpiprazole reduced impulsivity was measured by a change in Stop Signal Reaction Time (SSRT) on the SSRT task (a lower SSRT was suggestive of better inhibition). A white circle was shown for 500ms, followed by a left (<)/right (>) arrow. When an arrow was presented, participants responded as fast as possible with their index/middle finger. A titration procedure with 4 staircases started with stop signal delay (SSD) values of 100, 150, 200 & 250ms to determine participant's SSRT. The tasks included 3 runs with 166 repetition times (TRs), TR=2s; 5 minutes, 32 seconds/run; 96 go trials, 32 stop trials/ run. The total task duration was 16 minutes & 36 seconds. During scanning, the SSD was dynamically adjusted to yield a 50% successful inhibition rate, so that SSRT could be estimated for each participant. This resulted in approximately equal proportions of stop trials with & without a response|At baseline (Day 0), and Week 6 (Day 42).|All participants who had a valid baseline and a valid Week 6 fMRI scan assessment|||Millisecond||Standard Deviation|Mean
2597881|NCT02194933|Secondary|Change From Baseline to Week 3 in MCQ Score|"To measure delay discounting as an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ. Discounting rate is estimated using, k= (A/V)1/D, where k is the discounting rate parameter, V is the immediate reward, A is the higher delayed reward and D is the amount of days to the delayed reward. The MCQ consisted of 27 choices between immediate and delayed rewards. The participants chose repeatedly between 2 hypothetical sums of money: a smaller amount now or a larger amount in the future (ex: ''Would you prefer $27 today or $50 in 21 days?). The answers provided an estimate of the participant's discounting rate. The discounting rate parameter takes values between 0 and 1 and higher discounting rates indicated impulsivity."|During trial visits from Day 0 to Week 3 (Day 21).|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2597882|NCT02194933|Secondary|Change From Baseline to Week 6 in Monetary Choice Questionnaire (MCQ) Score|"To measure delay discounting as an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ. Discounting rate is estimated using, k= (A/V)1/D, where k is the discounting rate parameter, V is the immediate reward, A is the higher delayed reward and D is the amount of days to the delayed reward. The MCQ consisted of 27 choices between immediate and delayed rewards. The participants chose repeatedly between 2 hypothetical sums of money: a smaller amount now or a larger amount in the future (ex: ''Would you prefer $27 today or $50 in 21 days?). The answers provided an estimate of the participant's discounting rate. The discounting rate parameter takes values between 0 and 1 and higher discounting rates indicated impulsivity. It took 5 to10 minutes to complete the MCQ"|During trial visits from Day 0 to Week 6 (Day 42).|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2597883|NCT02194933|Secondary|Change From Baseline to Week 3 in Go/No-go Task Behavior|Brexpiprazole reduced impulsivity was measured by a change in false alarm rate on the Go/No-go task (a lower false alarm rate was suggestive of better inhibition). Participants were instructed to press a button as fast as they could to Stimulus A (eg, neutral face) that appeared on the screen (Go trials) and to NOT press a button to Stimulus B (eg, happy face) that appeared on the screen (No-go trials). The stimuli were presented randomly. The value calculated was the rate of incorrect response for each condition (Go and No-go).|At baseline (Day 0), and week 3 (Day 21) of the treatment phase|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment.|||Millisecond||Standard Deviation|Mean
2597884|NCT02194933|Secondary|Change From Baseline to Week 6 in Go/No-go Task Behavior|Brexpiprazole reduced impulsivity was measured by a change in false alarm rate on the Go/No-go task (a lower false alarm rate was suggestive of better inhibition). Participants were instructed to press a button as fast as they could to Stimulus A (eg, neutral face) that appeared on the screen (Go trials) and to NOT press a button to Stimulus B (eg, happy face) that appeared on the screen (No-go trials). The stimuli were presented randomly. The value calculated was the rate of incorrect response for each condition (Go and No-go).|At baseline (Day 0), week 6 (Day 42) of the treatment phase|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment.|||Millisecond||Standard Deviation|Mean
2597885|NCT02194933|Secondary|Change From Baseline to Week 3 in BIS-11|A participant-rated scale was used to assess impulsive personality traits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/ always) and the scores were used to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance and cognitive instability impulsiveness) and 3 second-order factors ( motor impulsiveness, nonplanning impulsiveness and attentional impulsiveness). The total score ranged from 30 to 120 with higher scores indicating impulsive personality traits, and took 10 to 15 minutes to complete the BIS-11.|At baseline (Day 0), and Week 3 (Day 21) of the treatment.|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment. All participants who had a valid baseline and a valid Week 3 or Week 6 fMRI scan assessment.|||units on a scale||Standard Error|Least Squares Mean
2597886|NCT02194933|Secondary|Change From Baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11)|A participant-rated scale was used to assess impulsive personality traits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/ always) and the scores were used to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance and cognitive instability impulsiveness) and 3 second-order factors ( motor impulsiveness, nonplanning impulsiveness and attentional impulsiveness). The total score ranged from 30 to 120 with higher scores indicating impulsive personality traits, and took 10 to 15 minutes to complete the BIS-11.|At baseline (Day 0), and Week 6 (Day 42) of the treatment.|The full analysis set consisted of all participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid postbaseline efficacy assessment. Change from baseline data were presented for participant count of 16, 12 for 2mg and 4mg arms, respectively.|||units on a scale||Standard Error|Least Squares Mean
2597887|NCT02194933|Secondary|Change From Baseline to Week 3 in fMRI BOLD Activation Score in the Right VLPFC, Scanned by fMRI During Performance of Tasks Associated With Impulsivity (SSRT Task, Go/No-go Task)|"Go/No-go: Participants were to press button fast to Stimulus A (neutral face) (Go trials) & to NOT press button to Stimulus B (happy face) (No-go trials). Task comprised 4 runs of 3 minutes & 8 seconds each. Each run included 36 target (Go) & 13 non target (No-go) stimuli. The stimuli were presented for 500ms with 2 to 14.5 inter-stimulus interval fixation cross in between. Target stimuli were pseudo-randomized across runs so that each participant was presented with 2 Happy Go & 2 Neutral Go conditions.~SSRT: White circle was shown for 500ms, followed by left (<)/right (>) arrow. When an arrow was presented, participants were to respond fast with their index/middle finger. A titration procedure with 4 staircases that started with stop signal delay (SSD) values of 100, 150, 200 & 250ms determined participant's SSRT.~Scores were not bounded by a minimum or maximum range, higher fMRI BOLD activation scores indicate increased brain blood flow, which reflects brain activity."|At baseline (Day 0), and week 3 (Day 21) of the treatment phase|All participants who had a valid baseline and a valid Week 3 fMRI scan assessment|||units on a scale||Standard Error|Least Squares Mean
2597888|NCT02194933|Primary|Change From Baseline Brain Activation in the VLPFC Based on Change From Baseline to Week 6 in fMRI BOLD Activation Score in the Right VLPFC During Performance of the SSRT Task|To evaluate the effect of brexpiprazole on brain regions activated by impulsive behavior (specifically, activation of the right VLPFC). Assessed by fMRI measurements taken when participants performed impulsivity assessment tasks. A white circle was shown for 500ms, followed by a left (<)/right (>) arrow. When an arrow was presented, participants responded as fast as possible with their index/middle finger. A titration procedure with 4 staircases started with stop signal delay (SSD) values of 100, 150, 200 & 250ms to determine participant's SSRT. The tasks included 3 runs with 166 repetition times (TRs), TR=2s; 5 minutes, 32 seconds/run; 96 go trials, 32 stop trials/ run. The total task duration was 16 minutes & 36 seconds. Scores were not bounded by a minimum or maximum range, higher fMRI BOLD activation scores indicate increased brain blood flow, which reflects brain activity.|At baseline (Day 0), and week 6 (Day 42) of the treatment phase|All participants who had a valid baseline and a valid Week 3 or Week 6 fMRI scan assessment.|||units on a scale||Standard Error|Least Squares Mean
2597889|NCT02194933|Primary|Change From Baseline Brain Activation in the Ventrolateral Prefrontal Cortex (VLPFC) Based on Change From Baseline to Week 6 in fMRI Blood Oxygen-level Dependent (BOLD) Activation Score in the Right VLPFC During Performance of the Go/No-go Task|To evaluate the effect of brexpiprazole on brain regions activated by impulsive behavior (specifically, activation of the right VLPFC). Assessed by fMRI measurements taken when participants perform tasks designed to assess impulsivity. The tasks to be performed in the scanner included the Go/No-go. Participants were asked to press a button as fast as they could to Stimulus A (eg, neutral face) that appeared on the screen (Go trials) & to NOT press a button to Stimulus B (eg, happy face) that appeared on the screen (No-go trials). The Go trials were presented at a higher frequency (eg, 75% of the time) than the No-go trials to build up a pre-potent response/response bias. Scores were not bounded by a minimum or maximum range, higher fMRI BOLD activation scores indicate increased brain blood flow, which reflects brain activity.|At baseline (Day 0), and week 6 (Day 42) of the treatment phase|All participants who had a valid baseline and a Week 6 fMRI scan assessment.|||units on a scale||Standard Error|Least Squares Mean
2597890|NCT02194699|Secondary|Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential|Assessments of ADA were performed using a tiered approach (screening, confirmatory and titering assays). Confirmed ADA positive samples were also tested for the presence of neutralising antibodies (nAb). ADA prevalence was defined as proportion of the study population having drug-reactive antibodies at any point in time. ADA incidence (treatment-emergent ADA) was defined as the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted to a 4-fold or higher level following drug administration. Note: 'positive' is denoted by 'pos' in some category titles.|Baseline (Week 0), Week 26, Week 56 (follow-up) and Week 72 (follow-up)|The ADA evaluable population included all patients in the safety analysis set (i.e. those who had received any IP) who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result.|||Participants|||Count of Participants
2597891|NCT02194699|Secondary|Serum Trough Concentration (Ctrough) of Tralokinumab During the Treatment Period up to Week 72|To evaluate the pharmacokinetics (PK), pre-dose blood samples were collected at each visit and tralokinumab concentrations in serum were determined. Mean Ctrough concentrations are presented at each indicated visit up to Week 72.|Blood samples were collected pre-dose at Baseline (Week 0), and at Week 2, Week 8, Week 26, Week 56 (follow-up) and Week 72 (follow-up)|All patients in the FAS who received tralokinumab and who had PK blood samples were included in the PK analysis set. Only patients in the biomarker positive and negative PK populations and with data available at the timepoints of testing were included in the analyses.|||micrograms/millilitre||Geometric Coefficient of Variation|Geometric Mean
2597892|NCT02194699|Secondary|Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry|"Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of assessments was calculated across all patients for the following healthcare encounter category:~• Spirometry."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.|||Assessments|||Number
2597910|NCT02194621|Primary|Anaerobic Bacteria|Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.|12 hours||||colony forming units||Standard Error|Mean
2599448|NCT02174523|Primary|Lurasidone AUC 0-τ||pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose|All subjects with evaluable PK data were included in PK data analysis.|||ng･h/mL||Geometric Coefficient of Variation|Geometric Mean
2597893|NCT02194699|Secondary|Asthma-related Healthcare Encounters by Type up to Week 52: Hospitalisations|"Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of days spent in hospital was calculated across all patients for the following healthcare encounter category:~• Hospitalisations (hospitalisations, intensive care and/or general care)."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.|||Days|||Number
2597894|NCT02194699|Secondary|Asthma-related Healthcare Encounters by Type up to Week 52|"Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of times the healthcare encounter occurred was calculated across all patients for each of the following categories:~Ambulance transport,~Emergency room visits,~Unscheduled outpatient visits (visit to specialist and/or visit to primary healthcare physician and/or other healthcare visit),~Home visits (home visit, physician and/or other healthcare professional),~Telephone calls (telephone calls to physician and/or nurse), and~Advanced pulmonary function test."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.|||Encounters|||Number
2597895|NCT02194699|Secondary|WPAI+CIQ: Activity Impairment at Week 52|"The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days.~The WPAI+CIQ outcomes for activity impairment are presented separately for those currently employed and for those currently in school and are expressed as mean impairment percentages at Week 52, with higher numbers indicating greater impairment.~Activity impairment = (Q10/10)*100. Note: QX refers to response to question number X on WPAI+CIQ questionnaire."|At Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Percent impairment||Standard Deviation|Mean
2597896|NCT02194699|Secondary|Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52|"The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days.~The WPAI+CIQ outcomes for productivity loss are presented separately for those currently employed and for those currently in school and are expressed as mean productivity loss (percentage) at Week 52, with higher numbers indicating less productivity.~Work Productivity Loss = {Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]}*100 (Absenteeism = Q2/(Q2+Q4)*100; Presenteeism = (Q5/10)*100).~Class Productivity Loss = {Q7/(Q7+Q8) + [(1-Q7/(Q7+Q8))x(Q9/10)]}*100 (Absenteeism = Q7/(Q7+Q8)*100; Presenteeism = (Q9/10)*100).~Note: QX refers to response to question number X on WPAI+CIQ questionnaire."|At Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Percent productivity loss||Standard Deviation|Mean
2597897|NCT02194699|Secondary|Number of Patients With ≥1 Asthma Exacerbation up to Week 52|The number of patients with ≥1 asthma exacerbation up to Week 52 is presented.|Baseline (Week 0) up to Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.|||Participants|||Count of Participants
2597898|NCT02194699|Secondary|Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage])|The patient captured night-time awakenings (yes/no) and the use of rescue medication during these awakenings (yes/no) each morning in the Asthma Daily Diary. Night-time awakenings (percentage) was defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data. The change from baseline in bi-weekly means (percentage) night-time awakenings due to asthma requiring rescue medication use at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Percentage of nights with awakenings||Standard Deviation|Mean
2597899|NCT02194699|Secondary|Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52|Home PEF testing was performed by the patient using an electronic, hand-held spirometer (peak flow meter) and was performed in the morning upon awakening (prior to taking their morning asthma controller) and in the evening at bedtime (prior to taking their evening asthma controller). The mean change from baseline in home PEF values at Week 52 are presented separately for morning and evening.|Baseline (Week 0) and Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||L/min||Standard Deviation|Mean
2597900|NCT02194699|Secondary|Change From Baseline in Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means)|Salbutamol, albuterol or levalbuterol were used as rescue medication during the study in the event of a worsening of asthma symptoms. Rescue medication use was measured by the bi-weekly mean number of inhalations (puffs) per day, calculated as: total morning puffs + total evening puffs + 2*(total morning nebuliser use + total evening nebuliser use)/ total number of days with data in bi-weekly period. The change from baseline in bi-weekly mean total asthma rescue medication use at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Puffs/day||Standard Deviation|Mean
2597901|NCT02194699|Secondary|Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at Week 52|The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The patient was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The questionnaire also included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state. The mean change from baseline in EQ-5D-5L VAS scores at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Scores on a scale||Standard Deviation|Mean
2597902|NCT02194699|Secondary|AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52|"The annual rate of exacerbations associated with an ER/UC visit or hospitalisation up to Week 52 are presented for non-adjudicated data (i.e. events assessed by the Investigator and recorded in the electronic case report form).~AAER = number of exacerbations*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks)."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.|||Events/year||95% Confidence Interval|Number
2597903|NCT02194699|Secondary|Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score|The ACQ-6 questionnaire is a shortened version of the ACQ (omitting FEV1 measurement) that assesses asthma symptoms (night-time awakenings, symptoms on waking, activity limitation, dyspnoea, wheezing) and rescue short-acting β2-agonists medication use during the past week. Questions were weighted equally and scored on a 7-point scale from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and ≤1.5 indicate partly controlled asthma and a score >1.5 indicates not well-controlled asthma. Individual changes of at least 0.5 were considered to be clinically meaningful. The mean change from baseline in ACQ-6 score at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Scores on a scale||Standard Deviation|Mean
2597904|NCT02194699|Secondary|Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score|The AQLQ(S)+12 is a questionnaire that measures health-related quality of life for patients with asthma aged 12 and older. The questionnaire comprises 32 questions and has 4 separate domains (asthma symptoms, activity limitations, emotional function and environmental stimuli). Patients were asked to recall their experiences during the previous 2 weeks and to score each of the questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The total score was calculated as the mean response to all questions, ranging from 1 (severe impairment) to 7 (no impairment). Individual AQLQ(S)+12 total score changes of ≥0.5 were considered to be clinically meaningful. The mean change from baseline in AQLQ(S)+12 score at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Scores on a scale||Standard Deviation|Mean
2597905|NCT02194699|Secondary|Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means)|Asthma symptoms during night-time and daytime were recorded by the patient each morning and evening in the Asthma Daily Diary. Symptoms were recorded using a 4-point response scale, which ranged from 0 to 3, where 0 indicated no asthma symptoms. Asthma symptom daytime score (recorded in the evening), night-time score (recorded in the morning), and total score were calculated separately. The daily asthma symptom total score was calculated by taking the sum of the night-time and daytime asthma symptom scores recorded each day, ranging from 0 to 6. A lower symptom score indicated a better outcome. The change from baseline in bi-weekly mean daily asthma symptom total score is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Scores on a scale||Standard Deviation|Mean
2597906|NCT02194699|Secondary|Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)|Lung function was assessed by FEV1 which was measured by spirometry. Spirometry was performed by the Investigator or authorised delegate according to American Thoracic Society/European Respiratory Society guidelines. The mean percent change from baseline in pre-BD FEV1 at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analyses.|||Percent change from baseline||Standard Deviation|Mean
2597907|NCT02194699|Primary|Annualised Asthma Exacerbation Rate (AAER) up to Week 52|"Asthma exacerbation was defined as a worsening of asthma that led to any of the following:~Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids.~An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for <24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids (see above).~An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma.~AAER = number of exacerbations*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks).~AAER in the tralokinumab group was compared to that seen in the placebo group up to Week 52 using a negative binomial model; rate ratios and rate reductions are both presented for comparative statistical analyses."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients with the potential to receive 52 weeks of IP and receiving any IP, irrespective of their protocol adherence and continued participation in the study.|||Events/year||95% Confidence Interval|Number
2597912|NCT02194088|Secondary|Side Effects|The investigators aimed assess if these would be a reason for discontinuation of treatment in a population with mild to moderate pain.Side effects will be assessed with a dichotomous measurement (yes/no)|baseline and 1 hour pain measurement|Participants were analyzed in terms of whether they endorsed or not the side effects (yes/no) Participants were not analyzed in terms of severity degree|||Participants|||Count of Participants
2597913|NCT02194088|Secondary|Catechol-O-methyltransferase (COMT) Polymorphism Correlation With Pain Relief|Difference in the baseline pain measurements compared to the 1-hour outcome measure will be correlated with Catechol-O-methyltransferase polymorphism|baseline and 1 hour pain measurement|Data were not collected||||||
2597914|NCT02194088|Primary|Pain Scores on Standardized Experimental Pain Testing|Pain scores on standardized experimental pain testing, with collection of Visual analog scales (VAS) on a 0-100 scale 0 (no pain)- 100 (worst pain imaginable) Higher values represent a worse outcome (more pain)|baseline and 1 hour pain measurement||||units on a scale||Standard Deviation|Mean
2597915|NCT02194062|Secondary|Lund-Kennedy Scoring for Nasal Endoscopy|The Lund Kennedy scoring system for nasal endoscopy rates the severity of the sinusitis based on the endoscopic appearance of the nasal mucosa. Edema, secretions and the presence of polyps are rated from 0-2, for a total maximum score of 6 per each side of the nose. Higher scores represent more severe disease.|6 months post-op||||units on a scale||95% Confidence Interval|Mean
2597916|NCT02194062|Primary|SNOT-22 Scores|SNOT22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.|6 months post-op.||||units on a scale||95% Confidence Interval|Mean
2597917|NCT02193880|Primary|Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD)|Patients will be monitored for Grade IV cGVHD and organ toxicity. Chronic assessment will be done using the conventional criteria.|From baseline and before day +100 of transplant.|we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough CD34 HSCT.|||Participants|||Count of Participants
2597918|NCT02193880|Primary|Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD)|Patients will be monitored for Grade IV aGVHD and organ toxicity. Acute assessment will be done using the modified Keystone (Glucksberg) consensus criteria.|From baseline and before day +100 of transplant.|we report data on 4 patients who received the actual therapy. The other 3 patients did not receive the experimental therapy for NOT collecting enough CD34 HSCT..|||Participants|||Count of Participants
2597919|NCT02193867|Secondary|Number Of Participants Achieving And Maintaining Transfusion-free Hemoglobin Normalization (TFHN)|"The number of participants achieving and maintaining TFHN are presented. For TFHN to be achieved, the participant had to meet the following criteria:~Two post baseline measurements of hemoglobin, at least 4 weeks apart, were above the age-adjusted lower limit of normal (LLN);~No known additional measurements of hemoglobin were below the age-adjusted LLN during the (minimum) 4 week period;~No transfusions were administered to the participant during the (minimum) 4 week period, or for 2 weeks prior to the first hemoglobin measurement in the (minimum) 4 week period. If all 3 criteria were met, a participant was considered to have achieved TFHN on the date of the first hemoglobin assessment in the 4 week period. A participant was considered to have maintained TFHN if he/she was transfusion free at Week 6 and had no abnormally low hemoglobin levels (levels below the age adjusted LLN) beginning at Week 8 of the study and continuing for at least 13 weeks (3 months)."|Baseline through Month 36|FAS: All participants who received any amount of sebelipase alfa (1.0, 3.0, 5.0, or 7.5 mg/kg qw) during the study and where applicable, met end point criteria.|||Participants|||Count of Participants
2597920|NCT02193867|Secondary|Change From Baseline In Serum Ferritin At Month 12, 24, And 36|The median change in the inflammatory marker serum ferritin from Baseline to Months 12, 24, and 36 is presented. The number of participants analyzed reflects only those from the FAS who had both a baseline value and a value at the indicated timepoint (Months 12, 24, and 36). Results are reported in micrograms (ug)/L.|Baseline, Month 12, Month 24, and Month 36|FAS: All participants who received any amount of sebelipase alfa (1.0, 3.0, 5.0, or 7.5 mg/kg qw) during the study and where applicable, met end point criteria.|||ug/L||Full Range|Median
2597921|NCT02193867|Secondary|Change From Baseline In Serum Transaminases (ALT And AST) At Month 12, 24, And 36|This outcome measure evaluated the effects of sebelipase alfa on liver function by measuring the change from baseline in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) at months 12, 24, and 36. Results are reported in units/liter (U/L).|Baseline, Month 12, Month 24, and Month 36|FAS: All participants who received any amount of sebelipase alfa (1.0, 3.0, 5.0, or 7.5 mg/kg qw) during the study and where applicable, met end point criteria.|||U/L||Full Range|Median
2597922|NCT02193867|Secondary|Number Of Participants With Stunting, Wasting, Or Underweight At Baseline, 12, 24, And 36 Months|"The number of participants who met criteria for the following 3 dichotomous indicators of under nutrition were reported. These indicators included the following:~Stunting was defined as at least 2 standard deviations below the median for length-for-age/height-for-age.~Wasting was defined as wasting at least 2 standard deviations below the median for weight-for-length/weight-for-height.~Underweight was defined as at least 2 standard deviations below the median for WFA."|Baseline to Month 12, Month 24, and Month 36|FAS: All participants who received any amount of sebelipase alfa (1.0, 3.0, 5.0, or 7.5 mg/kg qw) during the study and where applicable, met end point criteria.|||Participants|||Count of Participants
2597923|NCT02193867|Secondary|Change From Baseline In Percentiles For Weight For Age (WFA) At 12, 24, And 36 Months|This outcome measure evaluated the effects of sebelipase alfa on growth by measuring the changes from baseline in percentiles for WFA. Percentiles for WFA were summarized as observed values by visit. Baseline was defined as the last available assessment prior to the first infusion of sebelipase alfa.|Baseline, Month 12, Month 24, and Month 36|FAS: All participants who received any amount of sebelipase alfa (1.0, 3.0, 5.0, or 7.5 mg/kg qw) during the study and where applicable, met end point criteria.|||percentile||Full Range|Median
2597924|NCT02193867|Secondary|Median Age At Death|Age at death for participants who died during the study. All deaths were assessed by the Investigator as unrelated to study drug.|Baseline through Month 36|FAS: All participants who received any amount of sebelipase alfa (1.0, 3.0, 5.0, or 7.5 mg/kg qw) during the study and where applicable, met end point criteria.|||months||Full Range|Median
2597925|NCT02193867|Secondary|Percentage Of Participants Surviving To 12, 18, 24, And 36 Months Of Age|The percentage of participants in the FAS who survived to 12, 18, 24, and 36 months of age. The exact confidence interval was calculated using the Clopper-Pearson method. Participants with unknown survival status at the age specified in the analysis were excluded. At 36 months, there were 2 participants who were alive and still on study who had not yet reached the age specified in the analysis. As such, these participants were excluded from the calculation of percent surviving.|Baseline through Month 12, Month 18, Month 24, and Month 36|FAS: All participants who received any amount of sebelipase alfa (1.0, 3.0, 5.0, or 7.5 mg/kg qw) during the study and where applicable, met end point criteria.|||percentage of participants||95% Confidence Interval|Number
2597926|NCT02193867|Primary|Participants Experiencing Severe Treatment-emergent Adverse Events (TEAEs)|The number of participants experiencing severe TEAEs is presented for participants who received sebelipase alfa in this open-label study. Adverse events were obtained through spontaneous reporting or elicited by specific questioning or examination of the participant's parent or legal guardian. An adverse event was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant, whether or not causally related to administration of study drug. Adverse event severity was graded by the Investigator as mild, moderate, or severe based on definitions developed from Clinical Data Interchange Standards Consortium Study Data Tabulation Model standard terminology v3.1.1. Adverse events reporting was from the date of informed consent until completion of the follow-up visit at approximately 30 days after the last dose of study drug. A summary of all serious and other nonserious AEs regardless of causality is located in the Reported AE module.|Screening through Month 37|FAS: All participants who received any amount of sebelipase alfa (1.0, 3.0, 5.0, or 7.5 mg/kg qw) during the study and where applicable, met end point criteria.|||Participants|||Count of Participants
2597927|NCT02193828|Secondary|Composite Responder Analysis|A composite responder is a subject who had an improved assessment [values of 1 (very much improved), 2 (much improved), or 3 (minimally improved)] on the investigator global assessment and had a satisfied assessment [values of 1 (very satisfied) or 2 (quite satisfied)] on the subject assessment.|Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers.|||participants|||Number
2597928|NCT02193828|Secondary|Subject Satisfaction With Treatment|Subjects were asked to rate their satisfaction with treatment on a 5-point scale: 1 = very satisfied, 2 = quite satisfied, 3 = neither satisfied nor dissatisfied, 4 = quite dissatisfied, and 5 = very dissatisfied.|Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers.|||units on a scale||Standard Deviation|Mean
2597929|NCT02193828|Secondary|Investigator Global Assessment of Improvement With Treatment|Investigators were asked to determine the degree of improvement in the subject's treated nodule compared with screening on a 7-point scale: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers.|||units on a scale||Standard Deviation|Mean
2597930|NCT02193828|Secondary|Change From Baseline in Nodular Pain of the Treated Nodule at Day 57|After the nodule was squeezed using a dynamometer, subjects were asked to rate the amount of pain they felt on an 11-point visual analog scale (VAS) from 0 (no pain or discomfort) to 10 (extreme pain or discomfort). A negative change from baseline value reflects improvement from baseline (less pain) while a positive value reflects worsening.|Baseline, Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers. Subjects with an incomplete assessment (not done) on Day 57 were excluded.|||units on a scale||Standard Deviation|Mean
2597931|NCT02193828|Secondary|Percent Change From Baseline in Hardness of the Treated Nodule at Day 57|A durometer was used to assess nodule hardness on a scale of 0 (soft) to 100 (hard). Percent change = 100*(Day 57 hardness - baseline hardness)/baseline hardness. A negative value represents the improvement from baseline (softening) while a positive value represents worsening.|Baseline, Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers. Subjects with an incomplete assessment (not done) on Day 57 were excluded.|||percentage of change||Standard Deviation|Mean
2597932|NCT02193828|Secondary|Change From Baseline in Consistency of the Treated Nodules at Day 57|Investigators determined the consistency of the nodule through palpitation using a 5-point scale: 5 = hard (solid), 4 = firm throughout, 3 = moderate firmness, 2 = soft, and 1 = non-palpable. The change scores could range from +4 (greatest worsening in consistency) to -4 (greatest improvement in consistency); a negative change from baseline value reflects improvement from baseline (softening) while a positive value reflects worsening.|Baseline, Day 57|Analysis based on mITT population; all randomized subjects who received an injection of study medication and had pre- and post-baseline nodule measurements for both ultrasound and calipers. Subjects with an incomplete assessment (not done) on Day 57 were excluded.|||units on a scale||Standard Deviation|Mean
2597933|NCT02193828|Secondary|Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound|Percent change from baseline in surface area and volume of the treated nodule was determined from ultrasound measurements of the length, width, and depth of the nodule. Percent change = 100*(Day 57 area [or volume] - baseline area [or volume])/baseline area [or volume]. A negative value represents the improvement from baseline (decreased size) while a positive value represents worsening.|Baseline, Day 57|Analysis based on mITT population; all randomized subjects who received study medication and had pre- and post-baseline nodule measurements for ultrasound and calipers. Analytical outliers (subjects whose percent change in ultrasound volume was greater than the 75th percentile + 3× the interquartile range) were excluded.|||percentage of change||Standard Deviation|Mean
2597958|NCT02193178|Primary|Anterior Ocular Health - Palpebral Hyperemia and Roughness|Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe|Baseline and 2 weeks||||units on a scale|eyes|Standard Deviation|Mean
2599449|NCT02174523|Primary|Lurasidone AUC 0-24||pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose|All subjects with evaluable PK data were included in PK data analysis.|||ng･h/mL||Geometric Coefficient of Variation|Geometric Mean
2597934|NCT02193828|Primary|Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements|Percent change from baseline in surface area and volume of the treated nodule was determined from hand-held caliper measurements of the length and width of the nodule. Percent change = 100*(Day 57 area [or volume] - baseline area [or volume])/baseline area [or volume]. A negative value represents the improvement from baseline (decreased size) while a positive value represents worsening.|Baseline, Day 57|Analysis based on Modified Intent-to-Treat (mITT) population; all randomized subjects who received study medication and had pre- and post-baseline nodule measurements for ultrasound and calipers. Analytical outliers (subjects whose percent change in ultrasound volume was greater than the 75th percentile + 3× the interquartile range) were excluded.|||percentage of change||Standard Deviation|Mean
2597935|NCT02193815|Other Pre-specified|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg) change from baseline in same posture or SBP <90 mmHg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mmHg.|Baseline up to Day 12|The safety population included all enrolled participants who received at least 1 dose of investigational product.|||participants|||Number
2597936|NCT02193815|Other Pre-specified|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (e.g., urine human chorionic gonadotropin [hCG] for females of childbearing potential).|Baseline up to Day 12|The safety population included all enrolled participants who received at least 1 dose of investigational product.|||participants|||Number
2597937|NCT02193815|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. The number of participants with specified skin AEs was reported.|Baseline up to 28 days after last study drug administration (Day 21)|The safety population included all enrolled participants who received at least 1 dose of investigational product.|||participants|||Number
2597938|NCT02193815|Secondary|Global Clinical Assessment at Day 1, 8 and 12|"Global Clinical Assessment of the test fields was performed by visual examination using a 5-point score (-1=worsened; 0=unchanged [no effect]; 1=slight improvement; 2=clear improvement but not completely healed; 3=completely healed). Clinically apparent differences in erythema and infiltration will contribute to this global assessment. At baseline (Day 1), the score was documented as 0 (unchanged)."|Day 1, Day 8, Day 12|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.|||participants|||Number
2597939|NCT02193815|Secondary|Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB|The AUC of psoriatic skin thickness/EPB from Day 1 to Day 12 was determined using the linear trapezoidal rule. The mean raw values are reported.|Day 1 (baseline) up to Day 12|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.|||micrometers*day||Standard Deviation|Mean
2597940|NCT02193815|Secondary|Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8||Day 1 (Baseline), Day 8|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.|||micrometers||Standard Deviation|Mean
2597941|NCT02193815|Secondary|Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12||Day 1 (Baseline), Day 12|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.|||micrometers||Standard Deviation|Mean
2597942|NCT02193815|Secondary|Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12||Day 1 (Baseline), Day 12|The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.|||micrometers||Standard Deviation|Mean
2597943|NCT02193815|Primary|Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12|Psoriatic skin thickness was measured using a 20 megahertz (MHz) high frequency sonograph. Serial A-scans were composed and presented on a monitor as a section of the skin.|Day 1 (Baseline), Day 12|The Intent-to-Treat (ITT) population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.|||micrometers||Standard Deviation|Mean
2597959|NCT02193178|Primary|Lens Fit Acceptance|General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum)|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.|||units on a scale|eyes|Standard Deviation|Mean
2598013|NCT02192814|Secondary|Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 5||20 minutes prior infusion at Day 5|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2597944|NCT02193776|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|A TEAE was defined as any AE which started or worsened on or after first study drug administration up to and including the Day 70 follow-up visit (or up to and including 14 days after last study drug administration for participants not having Day 70 follow-up visit). Drug-related TEAEs were defined as TEAEs for which relationship to study drug was indicated as 'possible', 'probable', 'certain' or missing. TEAEs leading to death were defined as TEAEs resulted 'fatal' outcome. Serious TEAEs were defined as TEAEs for which serious was indicated as 'yes'. TEAEs leading to discontinuation of study drug were defined as TEAEs for which action taken with study drug was indicated as 'study drug stopped'. TEAEs leading to early withdrawal from study were defined as TEAEs resulted study discontinuation. Grade III and IV TEAEs were defined as TEAEs for which severity (DMID grade) was indicated as 'Grade 3 (severe)' and 'Grade 4 (potentially life-threatening)' or missing, respectively.|First study drug administration (Day 1) up to and including the Day 70 follow-up visit (or up to and including 14 days after last study drug administration for participants not having the Day 70 follow-up visit) (70 days)|The safety analysis population included all participants who were randomized (for the DS participant population) or assigned (for the MDR participant population) to study drug and received at least 1 administration of study drug.|||Participants|||Count of Participants
2597945|NCT02193776|Primary|Rate of Change in Time to Sputum Culture Positivity (TTP) Over 8 Weeks in the Mycobacterial Growth Indicator Tube (MGIT) System|The bactericidal activity (BA) was determined by the rate of change in TTP collected from overnight sputum samples over 8 weeks of treatment in the liquid culture media MGIT system, represented by the model-fitted log(TTP) results as calculated by the regression of the observed log(TTP) results over time. The bactericidal activity of log(TTP) over Day 0 to Day 56 (BATTP[0-56]) was presented and expressed as the daily percentage change in TTP from Day 0 to Day 56. The mean BATTP (0-56) was calculated from Bayesian non-linear mixed effects regression models fitted to log(TTP) collected from sputum samples (observed from Day 0 to Day 56).|Day 0 to Day 56 (8 weeks)|The modified intention-to-treat analysis population included all participants included in the safety analysis population for whom valid corresponding efficacy data were available. Pyrazinamide resistant participants were excluded from this analysis population (applicable to both participants with DS-TB and MDR-TB).|||percentage change in TTP/day||Standard Deviation|Mean
2597946|NCT02193490|Other Pre-specified|The Change in Mucoid Debris Strands Between Baseline and 8-weeks|"The presence of mucoid debris/strands over the ocular surface was assessed and the amount graded as the absence of mucoid debris (0) or presence of mucoid debris (1+, 2+ or 3+) with a bigger number indicating greater presence of mucoid debris with 3+ implying presence of the highest amount of mucoid debris and indicating the worst outcome."|Between baseline and 8-weeks of treatment||||score on a scale||Inter-Quartile Range|Median
2597947|NCT02193490|Primary|The Change in the Ocular Surface Disease Index Score|"Ocular Surface Disease Index (OSDI), a 12-item questionnaire, assesses symptom of ocular irritation in dry eye disease (DED) and how it affects functioning related to vision in the past week. It has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on 0 to 4 scale with 0 being none of the time and 4 being all of the time. OSDI score range from 0-100 with score 0-12 being normal, 13-22 being mild DED, 23-32 being moderate DED, and >33 being severe DED. OSDI=[(sum of scores for questions answered)×100]/[(total questions answered)×4]"|Between baseline and at 8 weeks of treatment||||score on a scale||Inter-Quartile Range|Median
2597948|NCT02193490|Primary|The Change in Corneal Surface Staining as Measured by Rose Bengal Dye Staining|Corneal staining score as measured by Rose Bengal (RB) dye staining using National Eye Institute (NEI) 1995 workshop grading scale. The dye was applied to each eye and a slit lamp was used to observe corneal staining. The NEI scale relies on a chart that divides the cornea into 5 sections and assigns a value from 0 (absent) to 3 (severe) to each section, based on the density of punctate staining, final staining score being the sum of individual section scores, for a range of 0 (minimum) -15 (maximum) points. Complete corneal staining clearance with RB dye defined as a score of 0 indicating the best outcome.|Between baseline and at 8 weeks of treatment||||score on a scale||Inter-Quartile Range|Median
2597949|NCT02193178|Primary|Investigator Acceptability|Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree.|Baseline and 2 weeks||||percentage of subjects|||Number
2597950|NCT02193178|Primary|Overall Preference|Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses|Baseline and 2 weeks||||percentage of subjects|||Number
2597951|NCT02193178|Primary|Preference - Handling|Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses|Baseline and 2 weeks|Missing data for handling preference for one participant.|||percentage of subjects|||Number
2597952|NCT02193178|Primary|Preference - Vision|Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses|Baseline and 2 weeks||||percentage of subjects|||Number
2597953|NCT02193178|Primary|Subjective Preference - Comfort|Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses|Baseline and 2 weeks||||percentage of subjects|||Number
2597954|NCT02193178|Primary|Visual Acuity|Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR.|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis.|||LogMAR||Standard Deviation|Mean
2597955|NCT02193178|Primary|Anterior Ocular Health - Conjunctival Staining and Indentation|Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe|Baseline and 2 weeks||||units on a scale|eyes|Standard Deviation|Mean
2597956|NCT02193178|Primary|Anterior Ocular Health - Corneal Staining|Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= >45% of area|Baseline and 2 weeks||||units on a scale|eyes|Standard Deviation|Mean
2597960|NCT02193178|Primary|Lens Fit - Overall Stability|Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.|||units on a scale|eyes|Standard Deviation|Mean
2597961|NCT02193178|Primary|Lens Fit - Rotation|Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation.|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis. Another participant did not wear habitual lens and therefore data was not collected for habitual lenses.|||percentage of eyes|eyes||Number
2597962|NCT02193178|Primary|Overall Satisfaction|Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied.|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis.|||units on a scale||Standard Deviation|Mean
2597963|NCT02193178|Primary|Handling|Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis.|||units on a scale||Standard Deviation|Mean
2597964|NCT02193178|Primary|Overall Vision|Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time.|2 weeks prior to baseline, Baseline, 2 weeks post|One participant discontinued and therefore data was not included in analysis.|||units on a scale||Standard Deviation|Mean
2597965|NCT02193178|Primary|Overall Comfort|Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.|2 weeks prior to baseline, Baseline, 2 weeks post baseline|One participant discontinued and therefore data was not included in analysis.|||units on a scale||Standard Deviation|Mean
2597966|NCT02193165|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 weeks||||units on a scale||Standard Deviation|Mean
2597967|NCT02193165|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|4 weeks||||units on a scale||Standard Deviation|Mean
2597968|NCT02193165|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|Baseline||||units on a scale||Standard Deviation|Mean
2597969|NCT02193165|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 weeks||||units on a scale||Standard Deviation|Mean
2597970|NCT02193165|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|4 weeks||||units on a scale||Standard Deviation|Mean
2597971|NCT02193165|Primary|Dental Plaque Scores|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|Baseline||||units on a scale||Standard Deviation|Mean
2597972|NCT02193087|Secondary|Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set|Percentage of participants with markedly abnormal standard safety laboratory values collected at any time after the first vaccination.|Days 8, 15, 91, 97 and 104|"The Safety Laboratory Sub-Set included randomly chosen participants from each treatment group for whom samples for clinical safety lab tests were collected and who received at least one vaccination dose. n in each of the categories is the number of participants with data available at the given time-point."|||percentage of participants|||Number
2597973|NCT02193087|Secondary|Percentage of Participants With Serious Adverse Events (SAEs)|A serious adverse event (SAE) is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|Up to 6 Months after the last dose (9 months)|SS included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
2597974|NCT02193087|Secondary|Percentage of Participants With Any Unsolicited Adverse Events (AEs)|Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study, that occurred at least once within 28 days after either vaccination. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The investigator assessed whether the AE was related to the study vaccination.|Up to Day 28 after each vaccination|SS included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
2597975|NCT02193087|Secondary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity|The percentage of participants with solicited systemic AEs of varying severity are reported. Solicited systemic AEs are defined as asthenia, fever, headache, malaise, and myalgia that occurred at least once within 14 days after either vaccination, as recorded by the participants in a diary. Participants with multiple episodes are categorized using the highest severity level. Percentages are based on the number of participants with diary data available.|Days 1 through 14 after each vaccination|Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
2597976|NCT02193087|Secondary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity|The percentage of participants with solicited local AEs at injection site of varying severity are reported. Solicited local AEs are defined as pain, erythema and swelling that occurred at least once within 7 days after either vaccination, as recorded by the participants in a diary. Participants with multiple episodes are categorized using the highest severity level. Percentages are based on the number of participants with diary data available.|Days 1 through 7 after each vaccination|Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose. “n” in each of the categories is the number of participants with data available for analysis.|||percentage of participants|||Number
2597977|NCT02193087|Secondary|Percentage of Participants With Solicited Systemic Adverse Events (AEs)|Solicited systemic AEs are defined as asthenia, fever, headache, malaise, and myalgia that occurred at least once within 14 days after either vaccination, as recorded by the participants in a diary. Percentages are based on the number of participants with diary data available.|Days 1 through 14 after each vaccination|Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
2597978|NCT02193087|Secondary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs)|Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred at least once within 7 days after either vaccination, as recorded by the participants in a diary. Percentages are based on the number of participants with diary data available.|Days 1 through 7 after each vaccination|Participants from the Safety Set (SS) with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose. “n” in each of the categories is the number of participants with data available for analysis.|||percentage of participants|||Number
2597979|NCT02193087|Secondary|Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Group B|A seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.|Months 1 and 4|PPS included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included. “n” in each of the categories is the number of participants with data available at the given time-point.|||percentage of participants||95% Confidence Interval|Number
2597980|NCT02193087|Secondary|Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Groups A and B Combined|A seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.|Month 1|Per-Protocol Set (PPS) included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1, and have no major protocol violations. Participants seropositive at Baseline are not included.|||percentage of participants||95% Confidence Interval|Number
2597981|NCT02193087|Secondary|Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D With Group B|Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4. ANOVA model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis.|Months 1 and 4|"PPS included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included. n in each of the categories is the number of participants with data available at the given time-point."|||titer||90% Confidence Interval|Least Squares Mean
2597982|NCT02193087|Primary|Geometric Mean Titer (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D To Groups A and B Combined|"Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.~A 90% Confidence Interval (CI) for the ratio of GMT (or equivalently the difference of the log transformed GMT) was provided, for each serotype, for the comparison of the lyophilized formulation (Group D) versus the liquid formulation 1 (Groups A+B combined). An Analysis of Variance (ANOVA) model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis."|Month 1|Per-Protocol Set (PPS) included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included.|||titer||90% Confidence Interval|Least Squares Mean
2597983|NCT02193074|Secondary|Number of Participants With Clinically Significant Changes From Baseline in Urinalysis Values||up to Day 394 (± 7 days) or early termination|Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure.|||participants|||Number
2598012|NCT02192814|Other Pre-specified|The Cumulative Partial-onset Seizure Frequency From Day -1 to Day 5|No descriptive statistics have been calculated for this exploratory Outcome Measure.|From Day -1 to Day 5|||||||
2597984|NCT02193074|Secondary|Summary of Shifts in 12-lead Electrocardiogram (ECG) Results|Shift to 'abnormal, not clinically significant' includes 'unknown' or 'normal' to 'abnormal, not clinically significant'. Shift to 'abnormal, clinically significant' includes 'unknown' or 'normal' to 'abnormal, clinically significant'.|up to Day 394 (± 7 days) or early termination|Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure and whose baseline value was not abnormal and who had at least one post-baseline value.|||participants|||Number
2597985|NCT02193074|Secondary|Number of Participants Meeting Selected Vital Sign Criteria Post-Baseline||up to Day 394 (± 7 days) or early termination|Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure and had an assessment.|||participants|||Number
2597986|NCT02193074|Secondary|Number of Participants With AEs Corresponding to Changes in Blood Chemistry Values||up to Day 394 (± 7 days) or early termination|Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure.|||participants|||Number
2597987|NCT02193074|Secondary|Number of Participants With AEs Corresponding to Changes in Hematology Values||up to Day 394 (± 7 days) or early termination|Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure.|||participants|||Number
2597988|NCT02193074|Secondary|Number of Participants Experiencing Adverse Events (AEs), Serious AEs (SAEs) and Discontinuations Due to AEs|AE: any unfavorable and unintended sign, symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. SAE: any AE that in the view of either the Investigator or Sponsor, meets any of the following criteria: results in death; is life threatening: that is, poses an immediate risk of death at the time of the event; requires in-patient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect in the offspring of the participant (whether male or female); is an important medical event in the opinion of the Investigator or Sponsor.|Screening through Day 394 (± 7 days) or early termination|Safety Population: all subjects who received ≥ 1 dose of study drug/sham procedure.|||participants|||Number
2597989|NCT02193074|Secondary|Time to Death or Permanent Ventilation in the Subgroup of Participants Above the Study Median Disease Duration|Estimated proportion of participants who died or required permanent ventilation (EAC-adjudicated events) among participants above the study median disease duration (13.1 weeks), by given duration thresholds, based on the Kaplan-Meier product-limit method.|Day 91, Day 182, Day 273, Day 364, Day 394|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure and were above the study median disease duration.|||proportion of participants|||Number
2597990|NCT02193074|Secondary|Time to Death or Permanent Ventilation in the Subgroup of Participants Below the Study Median Disease Duration|Estimated proportion of participants who died or required permanent ventilation (EAC-adjudicated events) among participants below the study median disease duration (13.1 weeks), by given duration thresholds, based on the Kaplan-Meier product-limit method.|Day 91, Day 182, Day 273, Day 364, Day 394|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure and were below the study median disease duration.|||proportion of participants|||Number
2597991|NCT02193074|Secondary|Percentage of Compound Muscular Action Potential (CMAP) Responders|CMAP is an electrophysiological technique that can be used to determine the approximate number of motor neurons in a muscle or group of muscles. A participant was defined as a CMAP responder if the CMAP amplitude at the peroneal nerve was increasing to or maintained at ≥ 1 mV (comparing to the baseline) based on assessment at the later of the Day 183, Day 302, or Day 394 study visits. Results are based on all available data.|assessed at the later of the Day 183, Day 302, or Day 394 study visits|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure with Day 183, Day 302, or Day 394 data; the last available assessment was used. (Participants who died or withdrew from the study were counted as non-responders and were included in the denominator for the calculation of the percentages.)|||percentage of participants|||Number
2597992|NCT02193074|Secondary|Percentage of Participants Not Requiring Permanent Ventilation||Up to Day 394|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure.|||percentage of participants|||Number
2597993|NCT02193074|Secondary|Summary of Time to Death|Estimated proportion of participants who died by given duration thresholds, based on the Kaplan-Meier product-limit method.|Day 91, Day 182, Day 273, Day 364, Day 394|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure and who died. Results are based on all available data.|||proportion of particiants|||Number
2597994|NCT02193074|Secondary|Percentage of Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) Responders|A participants was considered a CHOP-INTEND responder if the change from baseline in CHOP-INTEND total score is ≥ 4 points based on assessment at the later of the Day 183, Day 302, or Day 394 study visits. CHOP-INTEND tests includes 16 items structured to move from easiest to hardest with the grading including gravity eliminated (lower scores) to antigravity movements (higher scores). Total scores range from 0 to 64, with higher scores indicating better movement functioning. Results are based on all available data.|assessed at Baseline and the later of the Day 183, Day 302, or Day 394 study visits|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure with Day 183, Day 302, or Day 394 data; the last available assessment was used. (Participants who died or withdrew from the study were counted as non-responders and were included in the denominator for the calculation of the percentages.)|||percentage of participants|||Number
2597995|NCT02193074|Primary|Time to Death or Permanent Ventilation|Estimated proportion of participants who died or required permanent ventilation by a given study day, based on the Kaplan-Meier product-limit method. Time to death or permanent ventilation was defined as either tracheostomy or ≥ 16 hours ventilation/day continuously for > 21 days in the absence of an acute reversible event. This endpoint was adjudicated by a blinded, independent group of experienced clinicians, the Event Adjudication Committee (EAC), based on review of clinical study data and supporting information. Results are based on all available data.|Day 91, Day 182, Day 273, Day 364, Day 394|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure and who died or required permanent ventilation.|||proportion of participants|||Number
2597996|NCT02193074|Primary|Percentage of Motor Milestones Responders|"The definition of a motor milestones responder was based on improvement in the motor milestones categories in Section 2 of the Hammersmith Infant Neurological Examination (HINE), with the exclusion of voluntary grasp, as follows:~(i) subject demonstrates ≥ 2-point increase in the motor milestones category of ability to kick or achievement of maximal score on that category (touching toes), or a 1-point increase in the motor milestones category of head control, rolling, sitting, crawling, standing, or walking, and (ii) among the motor milestone categories, with the exclusion of voluntary grasp, there are more categories where there is improvement as defined in (i) than worsening. (For the category of ability to kick, worsening is defined as ≥ 2-point decrease or decrease to the lowest possible score of no kicking. For the other categories, worsening is defined as ≥ 1-point decrease.) The lowest possible score for the HINE is 0 (zero), and the highest possible score for the HINE is 28."|assessed at the later of the Day 183, Day 302, or Day 394 study visits|Intent-to-treat population: all randomized participants who received ≥ 1 dose of study drug/sham procedure with Day 183, Day 302, or Day 394 data; the last available assessment was used. (Participants who died or withdrew from the study were counted as non-responders and were included in the denominator for the calculation of the percentages.)|||percentage of participants|||Number
2597997|NCT02192905|Secondary|Social Problem Solving Inventory|The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability. The change from baseline to 16-weeks is calculated by subtracting the baseline score from the 16 week score and then doing a 1-sample t-test of whether or not the change was different than 0.|16-week follow-up||||Total score||Standard Deviation|Mean
2597998|NCT02192905|Secondary|% Weight Change|Measured in pounds with a digital scale|16 week follow-up||||percentage of pounds||Standard Deviation|Mean
2597999|NCT02192905|Secondary|% Weight Change|Measured in pounds with a digital scale|8-week follow-up||||percentage of pounds||Standard Deviation|Mean
2598000|NCT02192905|Secondary|Problem Solving Inventory|The social problem solving inventory measures strengths and weaknesses in ability to solve problems in all areas of life. The measure includes sub scales (positive problem orientation, rational problem-solving, negative problem orientation, impulsivity/carelessness style, and avoidance style). The means of the subscales are summed and then matched against an age chart to achieve the total score for the age being studied. This is done for each participant. The scoring range is 28 to 140. The higher the score the higher the problem solving ability.The change from baseline to 8-weeks is calculated by subtracting the baseline score from the 8 week score and then doing a 1-sample t-test of whether or not the change was different than 0.|8-week follow-up||||Total score||Standard Deviation|Mean
2598001|NCT02192905|Primary|Feasibility (Retention Rates)|Total attendance at groups and total withdrawn from the study|8-weeks||||Participants|||Count of Participants
2598002|NCT02192905|Primary|Feasibility (Recruitment Rates)|Recruitment rates include the total number of participants contacting us to participate, which includes the intervention participants plus those screened out prior to starting the intervention (Total screened = 559; Total intervention participants = 43)|Baseline|Of the total number of participants screened for this study (n=559), 7.69% (n=43) were enrolled into the intervention.|||Participants|||Count of Participants
2598003|NCT02192905|Primary|Feasibility (Total Habits Attempted)|Total amount of new habits attempted during the study|8-week follow-up||||mean habits attempted||Standard Deviation|Mean
2598004|NCT02192905|Primary|Feasibility (Total Uses)|Mean total uses of the problem solving function of the mobile application|8-week follow-up||||mean uses of the app||Standard Deviation|Mean
2598005|NCT02192879|Other Pre-specified|Serious Adverse Events Associated With Regional Catheter Placement|Serious adverse events in the 2 arms with regional catheters (TEA and PVB) will be monitored|postoperatively until removal of regional catheter removed, with an average of 3 days up to 7 days|only patients who had a catheter|||serious adverse events|||Number
2598006|NCT02192879|Secondary|Highest VAS Pain Scores With Coughing|Post-operative pain scores with coughing, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be measured. Pain score is from 0 (no hurt) to 10 (hurts worst).|postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days||||units on a scale||Standard Deviation|Mean
2598007|NCT02192879|Secondary|Incidence of Major Postoperative Complication|Major surgical, infectious, respiratory, cardiac, and renal complications will be recorded for subjects in each arm of the study.|time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise||||complications|||Number
2598008|NCT02192879|Secondary|Cumulative Postoperative Opioid Requirement|Cumulative postoperative opioid use in morphine equivalents will be recorded for subjects in the 3 arms of the study. The investigators hypothesize that the TEA and/or PVB arms may show less opioid use over PCA.|postpoperatively until regional catheter removed or subjects transitioned to an oral pain management regimen, an expected average of 3 days and up to 7 days||||mg||Standard Deviation|Mean
2598009|NCT02192879|Secondary|Gastrointestinal Recovery|Postoperative return of bowel function and time to first feeding will be recorded for each of the 3 groups.|postoperatively until return of bowel function, up to 7 days||||days||Standard Deviation|Mean
2598010|NCT02192879|Secondary|Hospital Length of Stay|Hospital length of stay will be recorded for each of the 3 groups to see if there is a statistical difference between groups.|time to discharge after surgery, with an expected average of approximately 7-10 days, up to 6 weeks if complications arise||||days||Standard Deviation|Mean
2598011|NCT02192879|Primary|Highest VAS Pain Score at Rest|Post-operative pain scores at rest, as assessed by Pain Assessment Scales (Wong-Baker Faces Scale and Visual Analog Pain Scale (VAS) will be the primary outcome measured. Pain scores will be collected per standard PACU protocol (every 60 minutes) and on the hospital ward at hours 2, 4, 6 and 12, and then daily until day 3 or when the epidural/paravertebral catheter is removed. Postoperative pain at rest will be defined as the highest VAS pain score reported by each patient at any time. Pain score is from 0 (no hurt) to 10 (hurts worst).|postoperatively until regional catheter removed, with an expected average of 3 days and up to 7 days||||units on a scale||Standard Deviation|Mean
2598014|NCT02192814|Secondary|Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 2||20 minutes prior infusion at Day 2|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2598015|NCT02192814|Secondary|Maximum Plasma Concentration (Cmax) for Lacosamide (LCM) (End of Infusion) on Day 1||20 minutes prior infusion at Day 1|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2598016|NCT02192814|Secondary|Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 5||20 minutes prior infusion at Day 5|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2598017|NCT02192814|Secondary|Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 2||20 minutes prior infusion at Day 2|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2598018|NCT02192814|Secondary|Plasma Trough Concentration (Ctrough) for Lacosamide (LCM) on Day 1||20 minutes prior infusion at Day 1|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2598019|NCT02192814|Primary|The Total Number of Subject Withdrawal Due to Adverse Events During the Study|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|During the study (Screening through End of Study (Day -1 through Day 6))|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.|||participants|||Number
2598020|NCT02192814|Primary|The Total Number of Subjects Experiencing at Least One Adverse Event During the Study|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|During the study (Screening through End of Study (Day -1 through Day 6))|The Safety Set (SS) consisted of all enrolled subjects who received at least 1 infusion of iv LCM.|||participants|||Number
2598021|NCT02192684|Primary|Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo|To evaluate the effects of pioglitazone versus placebo on AHI in patients with OSA.|8 weeks||||AHI events/hour||Inter-Quartile Range|Median
2598022|NCT02192606|Secondary|Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy|The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.|Time of Procedure End||||millileters||Standard Deviation|Mean
2598023|NCT02192606|Primary|Vaginal Cuff Closure Times|The primary endpoint is the vaginal cuff closure time at the time of a total laparoscopic hysterectomy. As the 2D laparoscopy system is standard during laparoscopic cases, our objective is to assess if there is a difference in vaginal cuff closure time when a 3D laparoscopy system is used instead. At time of the surgery, that patient will be randomized to either system. A resident or fellow will close the vaginal cuff and time to close the vaginal cuff will be recorded.|Start of vaginal cuff closure to end of vaginal cuff closure||||minutes||Standard Deviation|Mean
2598024|NCT02192541|Other Pre-specified|Number of Participants Who Had a Dose Limiting Toxicity (DLT)|A DLT is defined as an adverse event that is related (possibly, probably, or definitely) to administration of study drugs during cycle one and is a Grade ≥ 3 non-hematological toxicity. Grade ≥3 non-hematological toxicity felt to be related to study medications are: Grade 3 diarrhea if it is refractory to treatment; Grade 3 nausea and vomiting if it is refractory to anti-emetic therapy and unable to be corrected; rise in creatinine to Grade 3, not corrected to Grade 1 or less within 48 hours with intravenous (IV) fluids; Any Grade 4 corrected QT interval (QTc) prolongation; Grade 4 neutropenia ≥5 days or febrile neutropenia,...).|Cycle one (28 days)||||Participants|||Count of Participants
2598025|NCT02192541|Secondary|Number of Cycles on Treatment|The number of 28-day treatment cycles (ganetespib on days 1, 8, and 15; ziv-aflibercept on days 1 and 15) administered to each evaluable patient. Number represents treatment cycles that were started; not all cycles were completed.|up to 5 months|The number of participants who were evaluable for response|||cycles||Full Range|Median
2598026|NCT02192541|Secondary|Number of Participants According to Best Response Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)|Radiologic response assessments by computed tomography (CT) scans were performed at baseline and every two cycles to evaluate tumor response based on the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria for target lesions: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.|Baseline and every 2 months up to 5 months||||Participants|||Count of Participants
2598027|NCT02192541|Secondary|Modulation of Epidermal Growth Factor Receptor (EGFR) Expression|To evaluate for tumor distribution of EGFR, patients were to undergo 89Zr-immuno-positron emission tomography (PET) imaging with 89Zr-labeled EGFR-targeting panitumumab antibody evaluate modulation of EGFR client protein prior to and after treatment with the combination of ganetespib and ziv-aflibercept. Panitumumab is a fully human monoclonal antibody that targets EGFR and competes with endogenous ligands to block stimulation of EGFR. 89z-immuno-PET imaging with panitumumab as a targeting ligand allows for quantification of EGFR within tumors.|Cycle 1 Day 16|Data were not collected from any participant for this Outcome Measure. As the trial was closed before the maximum tolerated dose (MTD) was established, patients were not enrolled to an expansion phase, and samples for pharmacodynamics analysis were not obtained.||||||
2599930|NCT02169219|Secondary|Early Treatment Failures|Number of early treatment failures defined as patients who have new or worsening disease manifestations assessed at 4 weeks after study entry|4 weeks||||Participants|||Count of Participants
2598028|NCT02192541|Secondary|Modulation of Hypoxia-Inducible Factor 1 (HIF-1) Alpha|To determine whether the combination of ganetespib and ziv-aflibercept modulated intratumoral Hypoxia-inducible factor 1 (HIF-1)-alpha expression, tumor biopsies were to be analyzed for change in HIF-1-alpha expression by immunofluorescence assay (IFA). Paired pre-and post-combination treatment samples were to be compared for qualitative changes in levels of HIF-1- alpha expression. Cores were to be normalized against the percentage of tumor within the sample.|Cycle 2, Day 7|Data were not collected from any participant. Biopsies were to be collected from an expansion cohort treated at the maximum tolerated dose, after the conclusion of the dose escalation phase. Trial was closed before the MTD was established, patients were not enrolled to an expansion phase, and samples for pharmacodynamics analysis were not obtained.||||||
2598029|NCT02192541|Primary|Maximum Tolerated Dose (MTD) of the Combination of Ganetespib and Ziv-aflibercept|MTD is defined as the dose level at which no more than 1 of 6 patients experience a dose limiting toxicity (DLT) during the first cycle of the treatment, and the dose level below that at which at least 2 (of <6) patients have a DLT as a result of the drug. Determination of DLT is based on the first cycle of treatment.|Cycle one (28 days)|An MTD was not established because no MTD data were collected. The trial was terminated before the MTD was reached due to the decision of the drug supplier to suspend further clinical development of ganetespib.||||||
2598030|NCT02192541|Primary|Number of Participants With Grade 2 or Greater Adverse Events Possibly, Probably, or Definitely Related to Administration of the Study Drugs|Adverse Events were graded according to Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the Adverse Event. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to adverse event (AE). AEs were considered possibly attributable to both study drugs, except where otherwise noted. Star (*) symbol indicates that the AE is possibly related to Ziv-aflibercept and unlikely to be related to Ganetespib.|Date treatment consent signed to date off study, approximately 12 months and 44 days||||Participants|||Count of Participants
2598031|NCT02192541|Primary|Number of Participants With Serious and Non-serious Adverse Events Regardless of Attribution Assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v4.0|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 12 months and 44 days||||Participants|||Count of Participants
2598032|NCT02192307|Secondary|Change From Baseline Visual Analog Scale|Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced.|30 Days|Sixty (60) subjects received study products. Sixty (60) subjects completed the study.|||units on a scale||Standard Error|Mean
2598033|NCT02192307|Primary|Change From Baseline Air Challenge|The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.|30 days|Sixty (60) subjects received study products. Sixty (60) subjects completed the study.|||units on a scale||Standard Error|Mean
2598034|NCT02192190|Secondary|Change From Baseline to 8 Weeks in the WOMAC Total Score|The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales.The WOMAC total score was calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of 24 questions. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.|Baseline, 8 Weeks|FAS: Randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable WOMAC assessment at weeks 2, 4, 6 or 8.|||mm||95% Confidence Interval|Least Squares Mean
2598035|NCT02192190|Secondary|Change From Baseline to 8 Weeks in the WOMAC Stiffness Subscale|The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC stiffness subscale will be calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of 2 questions related to stiffness. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates. LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.|Baseline, 8 Weeks|FAS: Randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable WOMAC assessment at weeks 2, 4, 6 or 8.|||mm||95% Confidence Interval|Least Squares Mean
2609033|NCT02071095|Secondary|NK Cell Number|Natural killer cells or NK cells are part of the innate immune defense against infection and cancer.|at 48 weeks||||cells/µL||Standard Deviation|Mean
2598036|NCT02192190|Secondary|Number of Participants With a Response Rate Measured by the Outcome Measures for Rheumatology Committee and Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative (OMERACT-OARSI)|The responders according to OMERACT-OARSI criteria: participants with at least 50 % improvement in pain or in function scores, along with absolute improvement of 20 mm, were considered responders. Alternatively, participants were considered responders if they showed at least 20% improvement and absolute improvement of 10 mm in at least two of the following scores: pain, function and Patients Global Assessment (PGA) scores.|8 Weeks|FAS: Randomized participants who received at least 1 dose of study drug and had at least one post-dose efficacy assessment. N= participants analyzed in the full analysis set with an evaluable response rate at week 8.|||participants|||Number
2598037|NCT02192190|Secondary|Change in Baseline to 8 Weeks in Patient's Global Assessment of Osteoarthritis|"The PGA is a patient-rated instrument that measures their assessment of overall OA symptoms. It is based on the participant's response to the question Considering all the ways your osteoarthritis affects you, how are you doing today? using a 100 mm VAS (0=very good and 100=very poor). LSM mean was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates."|Baseline, 8 Weeks|FAS: Randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable PGA assessment at weeks 2, 4, 6 or 8.|||mm||95% Confidence Interval|Least Squares Mean
2598038|NCT02192190|Secondary|Change From Baseline to 8 Weeks in the WOMAC Physical Function Subscale|The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC Osteoarthritis Index version 3.1 was administered according to the study schedule. The WOMAC physical function subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 mm VAS; 0=very good and 100=very poor) of all 17 questions related to physical function. Least Square Mean (LSM) was calculated using a mixed-effects model repeated measures (MMRM) approach with treatment, visit and the interaction of treatment and visit were fitted as fixed effects in the model and baseline and pooled investigator site as baseline covariates.|Baseline, 8 Weeks|FAS: Randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable WOMAC assessment at weeks 2, 4, 6 or 8.|||mm||95% Confidence Interval|Least Squares Mean
2598039|NCT02192190|Primary|Change From Baseline to 8 Weeks in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale|The 24-question WOMAC Osteoarthritis Index assesses osteoarthritis (OA) symptoms using pain (5 questions), stiffness (2 questions) and physical function (17 questions) subscales. The WOMAC pain subscale was calculated for each participant at each time point for analysis as the mean score (range 0-100 millimeter [mm] VAS; 0=very good and 100=very poor) of all 5 questions related to pain. Bayesian posterior adjusted mean was calculated using a Bayesian Normal Dynamic Linear Model (NDLM) dose response model with baseline and pooled investigator site included as baseline covariates.|Baseline, 8 Weeks|Full Analysis Set (FAS) is the number of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose baseline efficacy assessment. N = participants in the full analysis set with an evaluable WOMAC assessment at weeks 2, 4, 6 or 8. The 95% Crl (Credible Interval) is reported, not confidence interval (CI).|||mm||95% Confidence Interval|Least Squares Mean
2598040|NCT02192164|Other Pre-specified|Smoking Habit Questionnaire: Mean Duration of Smoking Among Participants|Smoking habit questionnaire which was conducted on Day 1, assessed the data on smoking which included the mean duration (in years) of smoking among participants. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study.|Day 1|All treated participants with available post-baseline documentation. Here, ‘N’ signifies those participants who were evaluable for this measure. Data for this outcome measure was planned to be analyzed in smokers and former smokers.|||years||Standard Error|Mean
2598041|NCT02192164|Other Pre-specified|Smoking Habit Questionnaire: Mean Age of Participants at Which Cigarette Smoking Started and Quitted|Smoking habit questionnaire that was conducted on Day 1, assessed the data on smoking which included the age of participants at which they started smoking and the age at which they quitted smoking. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study.|Day 1|All treated participants with available post-baseline documentation. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies those participants who were evaluable for each arm. Data for this outcome measure was planned to be analyzed in smokers and former smokers.|||years||Standard Error|Mean
2598042|NCT02192164|Other Pre-specified|Smoking Habit Questionnaire: Smoking Status of Participants|Smoking habit questionnaire that was conducted on Day 1, assessed the data on smoking status of participants. Smoking status of participants was classified as never smoked, current smokers, and former smokers. Former smokers were defined as those participants who had stopped smoking at least 1 year prior to the study.|Day 1|All treated participants with available post-baseline documentation.|||participants|||Number
2598043|NCT02192164|Secondary|Percent Change From Baseline in Psoriasis Assessment and Severity Index (PASI) at Week 12 and 24|Percentage improvement in PASI score from baseline was calculated at Week 12 and 24 in terms of percent change from baseline. PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.|Baseline, Week 12, 24|All treated participants with available post-baseline documentation.|||percent change||Standard Deviation|Mean
2598125|NCT02190721|Secondary|Time to ANC Recovery To ≥2.0 * 10^9/L From ANC Nadir||ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||days||Standard Deviation|Mean
2598044|NCT02192164|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12 and 24|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.|Week 12, 24|All treated participants with available post-baseline documentation.|||percentage of participants|||Number
2598045|NCT02192164|Secondary|Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 12|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.|Baseline, Week 12|All treated participants with available post-baseline documentation.|||units on a scale||Standard Deviation|Mean
2598046|NCT02192164|Primary|Change From Baseline in Psoriasis Assessment and Severity Index (PASI) Score at Week 24|PASI score is the combined assessment of lesion severity and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Body divided into 4 sections (head and neck [h], arms [u], trunk [t], legs [l]); each area scored by itself and scores combined for final PASI score. For each section, percent body surface area (A) of skin involved was estimated: 0 (no involvement) to 6 (90-100 percent involvement), severity estimated by clinical signs: erythema (E), induration (I), scaling (S); 5 point scale: 0 (no involvement) to 4 (very marked involvement). Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4.|Baseline (Day 1), Week 24|All treated participants with available post-baseline documentation.|||units on a scale||Standard Deviation|Mean
2598047|NCT02192099|Primary|The Number of Participants Who Experience an Adverse Event Over the Course of the Study.|An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period.|48 Months|The Safety Population will consist of all subjects who received any injection of study drug.|||Participants|||Number
2598048|NCT02191865|Secondary|Number (%) of Subjects With Drug-related Adverse Events (AEs)|Number (%) of subjects with drug-related Adverse events (AEs)|(AEs) during the 'on-treatment' period (from administration of trial medication until the end of the 28-day residual effect period); Up to 29 days|TS|||percentage of participants|||Number
2598049|NCT02191865|Secondary|AUC (0-tz) of Nintedanib|AUC (0-tz) (Area under the concentration-time curve of the Nintedanib in plasma over the time interval from 0 to the last quantifiable drug plasma concentration)|Pre-dose and 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h after drug administration|Pharmacokinetic set (PKS): The PKS included all subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2598050|NCT02191865|Primary|Cmax of Nintedanib|Cmax (Maximum measured concentration of the Nintedanib in plasma)|Pre-dose and 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h after drug administration|Pharmacokinetic set (PKS): The PKS included all subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the evaluation of PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2598051|NCT02191865|Primary|AUC (0-inf) of Nintedanib|AUC (0-inf) (Area under the concentration-time curve of the Nintedanib in plasma over the time interval from 0 extrapolated to infinity)|Pre-dose and 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h after drug administration|Pharmacokinetic set (PKS): The PKS included all subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2598052|NCT02191618|Primary|Percentage of Subjects With Complete Aneurysm Occlusion Assessed Using the WEB Occlusion Scale (WOS) Without Retreatment, Recurrent Subarachnoid Hemorrhage, Without Significant Parent Artery Stenosis (>50% Stenosis) at One Year After Treatment|The primary effectiveness endpoint was defined as the percentage of subjects with complete aneurysm occlusion assessed using the WEB Occlusion Scale (WOS) without retreatment, recurrent subarachnoid hemorrhage, without significant parent artery stenosis (>50% stenosis) at one year after treatment in the mITT population.|12 months|The overall number of participants analyzed is 143 due to 3 subjects withdrawing and 4 subjects that missed their 1 year follow up visit.|||Participants|||Count of Participants
2598053|NCT02191618|Primary|The Primary Safety Endpoint Included Any Death or Major Stroke in the First 30 Days and Neurologic Death or Ipsilateral Major Stroke Between Day 31 and Day 365.|The study's primary safety endpoint was the proportion of subjects with death of any nonaccidental cause or any major stroke (defined as an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the National Institutes of Health Stroke Scale (NIHSS)) within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to 365 days after treatment.|12 months||||Participants|||Count of Participants
2598054|NCT02191605|Primary|Number of Participants Abstinent From Marijuana for the 90 Days Prior to Delivery|Marijuana use will be measured at the time of delivery of their infant by self-report (TimeLine Follow Back interview - TLFB) and hair toxicology analysis. This will represent the number of participants who were abstinent (reported no marijuana use and had a negative hair toxicology results) from marijuana for the 90 days prior to delivery.|self-reported use during 90 days prior to delivery of their baby||||Participants|||Count of Participants
2598055|NCT02191605|Primary|Number of Participants Abstinent From Marijuana for the 7 Days Prior to Delivery|Marijuana use will be measured at the time of delivery of their infant by self-report (TimeLine Follow Back interview - TLFB) and urine analysis. This will represent the number of participants who abstinent (reported no marijuana use and had a negative toxicology urine screen) from marijuana for the 7 days prior to delivery.|self-reported use during 7 days prior to delivery of their baby||||Participants|||Count of Participants
2598056|NCT02191579|Secondary|Percentage of Participants With a ≥ 70% Decrease From Baseline in the Frequency of Headache Days|Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. The percentage of participants with a ≥ 70% decrease in headache days in the 28-day period prior to Week 32 relative to Baseline (28-day period prior to Day 1) is reported.|Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32|ITT Set included all randomized participants.|||percentage of participants|||Number
2598057|NCT02191579|Secondary|Change From Baseline in Headache Impact Test (HIT-6) Total Score|"The HIT-6 is a valid disease-targeted measure used to assess the impact of headaches, comprised of 6 items that assess pain, role functioning, social functioning, cognitive functioning, vitality, and psychological distress. A total score is created by summingacross all items, and ranges from 36 (no impact) to 78 (severe impact) reflecting a best to worst scoring.~A negative change from Baseline (a lower score) indicates improvement."|Baseline (Day 1) to the last 28-day period ending with Week 30|Participants from the ITT Set, all randomized participants, with data available for analysis.|||score on a scale||Standard Deviation|Mean
2598058|NCT02191579|Secondary|Change From Baseline in the Frequency of Headache Days Per 28-day Period|Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. A negative change from Baseline (less headache days) indicates improvement.|Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32|ITT Set included all randomized participants.|||days||Standard Deviation|Mean
2598059|NCT02191579|Primary|Percentage of Participants With a ≥ 50% Decrease From Baseline in the Frequency of Headache Days|Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. The percentage of participants with a ≥ 50% decrease in headache days in the 28-day period prior to Week 32 relative to Baseline (28-day period prior to Day 1) is reported.|Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32|ITT Set included all randomized participants.|||percentage of participants|||Number
2598060|NCT02191397|Secondary|Number of Participants With Suicidal Ideation or Behavior During Treatment Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)|"C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. It consists of 10 items, each with two possible answers (yes/no). Suicidal ideation was interpreted if yes answer at any time during treatment to any one of the five suicidal ideation questions (item 1-5) on the C-SSRS. Suicidal behavior was interpreted if a yes answer at any time during treatment to any one of the five suicidal behavior questions (item 6-10) on the C-SSRS. Suicidal ideation or behavior is interpreted if a yes answer at any time during treatment to any one of the ten suicidal ideation and behavior questions (item 1-10) on the C-SSRS. Number of participants with at least one on-treatment C-SSRS assessment were analyzed. Only those participants with data available at the specified time points were analyzed."|Baseline and up to Taper visit (Week 9)|Safety Population|||Participants|||Number
2598061|NCT02191397|Secondary|Change From Baseline in Changes in Sexual Function Questionnaire (CSFQ)|CSFQ is a questionnaire about sexual activity and sexual function (sexual intercourse, masturbation, sexual fantasies and other activity). CSFQ is a gender-specific questionnaire. Both male and female versions consist of 14 items, each with 5 possible answers. CSFQ has a score in a range of 14 to 70. Higher score indicates higher sexual activity and sexual function. Value at Day 0 (Week 0) was considered as Baseline value. Change from Baseline at Week 8 was calculated by subtracting the Baseline score from the specific post-Baseline score. Only those participants with data available at the specified time points were analyzed.|Baseline (Day 0) and Week 8|Safety Population|||Scores on a scale||Standard Deviation|Mean
2598062|NCT02191397|Secondary|Number of Participants With Electrocardiogram (ECG) Data Outside the Clinical Concern Range|ECG was recorded at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). PR interval <110 or >220 millisecond (msec); QRS interval <60 or >120 msec and corrected QT (QTc) interval >450 msec were considered as values outside of clinical concern range and were presented as 'High' or 'Low' values. Number of participants with ECG data outside of clinical concern range at any post-Baseline visit are presented. Only those participants with data available at the specified time points were analyzed.|Up to Week 10|Safety Population|||Participants|||Number
2598063|NCT02191397|Secondary|Number of Participants With Vital Sign Parameters Outside the Clinical Concern Range|Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were taken at Screening (within 14 days prior to dosing), randomization visit (Week 0) and at Weeks 1, 2, 4, 6, 8, Taper visit (Week 9) and Follow-up visit (Week 10). SBP <30 or >170 millimeter of mercury (mmHg); DBP <20 or >110 mmHg and heart rate <40 or >120 beats per minute (bpm) were considered as values outside of clinical concern range and were presented as 'High' or 'Low' values. Number of participants with vital signs outside of clinical concern range at any post-Baseline visit are presented. Only those participants with data available at the specified time points were analyzed.|Up to Week 10|Safety Population|||Participants|||Number
2598064|NCT02191397|Secondary|Number of Participants With Urinalysis Data Outside the Normal Range|Urine samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Number of participants with urine specific gravity and potential of hydrogen (pH) outside (higher or lower) the normal range are presented. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 10|Safety Population|||Participants|||Number
2598065|NCT02191397|Secondary|Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points|Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 10|Safety Population|||10^12 cells per liter||Standard Deviation|Mean
2598066|NCT02191397|Secondary|Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points|Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 10|Safety Population|||Femtoliter||Standard Deviation|Mean
2598067|NCT02191397|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points|Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 10|Safety Population|||Picograms||Standard Deviation|Mean
2598068|NCT02191397|Secondary|Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points|Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 10|Safety Population|||Millimole per liter (mmol/L)||Standard Deviation|Mean
2598069|NCT02191397|Secondary|Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points|Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 10|Safety Population|||International Units per liter (IU/L)||Standard Deviation|Mean
2598070|NCT02191397|Secondary|Change From Baseline in Total Bilirubin, Direct Bilirubin and Creatinine at the Indicated Time Points|Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 10|Safety Population|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2598071|NCT02191397|Secondary|Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points|Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 10|Safety Population|||Giga cells per liter (GI/L)||Standard Deviation|Mean
2598072|NCT02191397|Secondary|Change From Baseline in Hematocrit at the Indicated Time Points|Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 10|Safety Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
2598073|NCT02191397|Secondary|Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points|Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Week 10|Safety Population|||Gram per Liter (G/L)||Standard Deviation|Mean
2598081|NCT02191397|Secondary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Weeks 1, 2, 4, 6 and 8|MADRS is a 10-point rating scale. Each item is scored on a scale of 0-6, with a total score range of 0-60. Higher score indicates worst symptoms. This scale is mainly used to assess the efficacy of antidepressant treatment. The ratings were based on the signs and symptoms during the preceding week prior to the visit. Values at Day0, Week 0 was considered as Baseline value. The observed MADRS total score was considered as missing if any item is missing. Change from Baseline in MADRS was obtained by subtracting the Baseline value from the specific post-Baseline value. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points.|Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8|PP Population|||Scores on a scale||Standard Error|Least Squares Mean
2598074|NCT02191397|Secondary|Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious AE (SAE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Participants who received any of the study treatment and had any non-serious AE or SAE were considered for analysis. Safety Population comprised of all participants who took at least one dose of the study medication.|Up to Week 10|Safety Population|||Participants|||Count of Participants
2598075|NCT02191397|Secondary|"Percentage of Participants With a Clinical Global Impression Global Improvement (CGI-I) Score of 1 (Very Much Improved) or 2 (Much Improved) at Weeks 1, 2, 4, 6 and 8"|"For CGI-I rating, the raters indicated their assessment of the participant's total improvement or worsening compared to the participant's condition at the Baseline visit, whether or not the improvement or worsening was thought to be treatment related. Scores ranges from 0 to 7 where 0 represents Not assessed, and the remaining values 1-7 represent Very much improved (1) to Very much worse (7). Participants with score 0 were excluded from analysis. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points."|Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8|PP Population|||Percentage of Participants|||Number
2598076|NCT02191397|Secondary|Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score at Weeks 1, 2, 4, 6 and 8|"CGI-S records the severity of illness at specific time points, with a range of responses from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants with zero values (0) representing Not assessed were excluded from analysis. Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was obtained by subtracting the Baseline value from the specific post-Baseline value. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points."|Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8|PP Population|||Scores on a scale||Standard Error|Least Squares Mean
2598077|NCT02191397|Secondary|Change From Baseline in HAMD-17 Sleep Disorder Subscale Score (Sum of Scores of Items 4, 5 and 6) at Weeks 1, 2, 4, 6 and 8|HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Sleep Disorder subscale score was derived as sum of scores of items 4, 5 and 6 from HAMD-17. This subscale has a score in a range of 0 (absence of condition) to 6 (most severe condition). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points.|Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8|PP Population|||Scores on a scale||Standard Error|Least Squares Mean
2598078|NCT02191397|Secondary|Change From Baseline in HAMD-17 Retardation Subscale Score (Sum of Scores of Items 1, 7, 8 and 14) at Weeks 1, 2, 4, 6 and 8|HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Retardation subscale score was derived as sum of scores of items 1, 7, 8 and 14 from HAMD-17. This subscale has a score in a range of 0 (absence of condition) to 14 (most severe condition). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points.|Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8|PP Population|||Scores on a scale||Standard Error|Least Squares Mean
2598079|NCT02191397|Secondary|Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score (Sum of Scores of Items 10, 11, 12, 13, 15 and 17) at Weeks 1, 2, 4, 6 and 8|HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Anxiety/Somatization subscale score was derived as sum of scores of items 10, 11, 12, 13, 15 and 17 from HAMD-17. This subscale has a score in a range of 0 (absence of condition) to 18 (most severe condition). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points.|Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8|PP Population|||Scores on a scale||Standard Error|Least Squares Mean
2598080|NCT02191397|Secondary|Change From Baseline in HAMD-17 Depressed Mood Subscale Score (Score of Item 1) at Weeks 1, 2, 4, 6 and 8|HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Depressed Mood Subscale is a factor score of item-1 (Depressed Mood) of HAMD-17 scale. This subscale has a score in a range of 0 (absence of depressed mood feelings) to 4 (when participants report virtually only these feeling states in his/her spontaneous verbal and non-verbal communicationtotal score). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points.|Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8|PP Population|||Scores on a scale||Standard Deviation|Least Squares Mean
2598121|NCT02190721|Secondary|Time to ANC Recovery To ≥2.0 * 10^9/L From Start of Chemotherapy||ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||days||Standard Deviation|Mean
2598082|NCT02191397|Secondary|Sustained Remission Rate Based on HAMD-17 Total Score|HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Sustained remission was defined as remission at end of acute treatment phase and an earlier visit and non-missing HAMD-17 total scores at all visits between these two visits <=8.|Up to Week 8|PP Population|||Percentage of Participants|||Number
2598083|NCT02191397|Secondary|Sustained Response Rate Based on HAMD-17 Total Score|HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Sustained response was defined as response at end of acute treatment phase and an earlier visit and the decrease from Baseline in non-missing HAMD-17 total scores at all visits between these two visits by at least 40%.|Up to Week 8|PP Population|||Percentage of Participants|||Number
2598084|NCT02191397|Secondary|Remission Rate Based on HAMD-17 Total Score|HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Remission was defined as HAMD-17 total scores at end of acute treatment phase (Week 8) <=7.|Up to Week 8|PP Population|||Percentage of Participants|||Number
2598085|NCT02191397|Secondary|Response Rate Based on HAMD-17 Total Score|HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Response was defined as decrease in HAMD-17 total scores at end of acute treatment phase (Week 8) relative to Baseline by at least 50%. Non-responder Imputation was used in calculation of rates.|Up to Week 8|PP Population|||Percentage of Participants|||Number
2598086|NCT02191397|Primary|Mean Change in Hamilton Depression Rating Scale - 17 (HAMD-17) Total Score From Baseline to End of Acute Treatment Phase (Week 8)|HAMD-17 is used to assess the severity of depression and symptom improvement. It consisted of 17 questions. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Change from Baseline was calculated by subtracting the Baseline total score (at Day 0, Week 0) from Week 8 observed total score. The Per Protocol (PP) Population is defined as all randomized participants in the Intent-To-Treat (ITT) Population who do not meet criteria of a major protocol deviation, with overall compliance of active drug for acute treatment phase in the range of 75%-125% and complete the first 6 weeks treatment and has HAMD-17 assessment at/after week 6 (that is >=35 days). All participants in the PP population were included in the mixed model repeated measures analysis. Only those participants with data available at the specified time point were analyzed.|Baseline (Week 0) and Week 8|PP Population|||Scores on a scale||Standard Error|Least Squares Mean
2598087|NCT02191267|Secondary|Beta-Amyloid (Aβ) Protein Uptake.|Mean and standard deviation for standardized uptake value ratios (SUVr) for posterior cingulate, superior parietal, lateral frontal, medial frontal, lateral temporal, and occipital brain regions. Each [F18]-Florbetapir (Beta-Amyloid) scan consisted of a 70-minute dynamic acquisition after bolus intravenous injection of 10 mCi of [18F]-Florbetapir. SUVr images were constructed from the sum of the 50-70 minute frames resulting in late SUVr distribution maps.|Day 2 - of 2 day study.||||SUVr||Standard Deviation|Mean
2598088|NCT02191267|Primary|Tau Protein Uptake..|Whole brain mean (and standard deviation) cortical value derived from standardized uptake value ratio (SUVr). Each [F18]-T807 tau scan consisted of a 60-minute dynamic acquisition after bolus intravenous injection of 10 mCi of [18F]-T807, followed by a second 20-minute dynamic imaging (list mode) acquisition from 80-100 minutes. SUVr images were constructed from the sum of the 80-100 minute frames resulting in late SUVr distribution maps.|Day 1 - of 2 day study.||||SUVr||Standard Deviation|Mean
2598089|NCT02191137|Secondary|Change From Week 16 to Week 24 in the 6MWD (Completers Analysis Set Only)|Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for 6MWD at week 24.|||Meters||Standard Deviation|Mean
2598090|NCT02191137|Secondary|Change From Baseline to Weeks 16 and 24 in the 6MWD|"Six-minute walk distance (6MWD) was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Week 16 to Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 67 patients were evaluable for 6MWD at week 24.|||Meters||Standard Deviation|Mean
2598091|NCT02191137|Secondary|Change From Week 16 to Week 24 in the Modified Borg Dyspnea Scale (Completers Analysis Set Only)|The Modified Borg Dyspnea Scale assessed the intensity of the patient's dyspnea from 0 (best) to 10 (worst).|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for Modified Borg Dyspnea Scale at Week 24.|||Scores||Standard Deviation|Mean
2598122|NCT02190721|Secondary|Time to ANC Recovery To ≥1.0 * 10^9/L From Start of Chemotherapy||ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||days||Standard Deviation|Mean
2598092|NCT02191137|Secondary|Change From Baseline to Weeks 16 and 24 in the Modified Borg Dyspnea Scale|"The Modified Borg Dyspnea Scale assessed the intensity of the patient's dyspnea from 0 (best) to 10 (worst). In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Week 16 to Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 58 patients were evaluable for Modified Borg Dyspnea Scale at week 24.|||Scores||Standard Deviation|Mean
2598093|NCT02191137|Secondary|Change From Week 16 to Week 24 in the WHO Functional Class (Completers Analysis Set Only)|"Functional class was determined by the WHO classification:~I: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.~II: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope.~III: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.~IV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity."|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for WHO Function Class at Week 24.|||Percentage of participants|||Number
2598094|NCT02191137|Secondary|Change From Baseline to Weeks 4, 16, and 24 in the WHO Functional Class|"Functional class was determined by the WHO classification:~I: Patients with PH (pulmonary hypertension) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.~II: Patients with PH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope.~III: Patients with PH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.~IV: Patients with PH with inability to carry out any physical activity without symptoms. These patients manifest signs of right-heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.~In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 75 patients were evaluable for WHO Function Class at Week 16 or Last Before.|||Percentage of participants|||Number
2598095|NCT02191137|Secondary|Change From Week 16 to Week 24 in the SF-12 PCS Score and MCS Score (Completers Analysis Set Only)|SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient's point of view. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for PCS and MCS at Week 24.|||Scores||Standard Deviation|Mean
2598096|NCT02191137|Secondary|Change From Baseline to Weeks 4, 16, and 24 in the Short Form-12 Health Survey (SF-12) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score|"SF-12v2® Health Survey is a 12-item questionnaire to measure functional health and well-being from the patient's point of view. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 73 patients were evaluable for PCS and MCS at Week 4.|||Scores||Standard Deviation|Mean
2598097|NCT02191137|Secondary|Change From Week 16 to Week 24 in the WLQ Percentage of Productivity Loss (Completers Analysis Set Only)|The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 40 patients in Completer analysis set were evaluable for WLQ percentage of productivity loss at week 24.|||Percentage||Standard Deviation|Mean
2598098|NCT02191137|Secondary|Change From Week 16 to Week 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands, and Output Demands Scores (Completers Analysis Set Only)|The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 40 patients in Completer analysis set were evaluable for WLQ at Week 24.|||Scores||Standard Deviation|Mean
2598123|NCT02190721|Secondary|Time to ANC Recovery To ≥2.0 * 10^9/L From Start of Tbo-filgrastim Administration||ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||days||Standard Deviation|Mean
2598124|NCT02190721|Secondary|Time to ANC Recovery To ≥1.0 * 10^9/L From Start of Tbo-filgrastim Administration||ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||days||Standard Deviation|Mean
2598099|NCT02191137|Secondary|Change From Baseline to Weeks 4, 16, and 24 in the WLQ Percentage of Productivity Loss|"The WLQ is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Using an algorithm, WLQ scale scores can be converted into an estimate of productivity loss. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 37 patients were evaluable for WLQ percentage of productivity loss at week 4.|||Percentage||Standard Deviation|Mean
2598100|NCT02191137|Secondary|Change From Baseline to Weeks 4, 16, and 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands and Output Demands Scores|"The Work Limitations Questionnaire (WLQ) is an 8-item questionnaire that measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems, and health-related productivity loss (Presenteeism). The WLQ's terms are aggregated into four scales (i.e. Time Management, Physical demands, Mental-interpersonal demands, Output demands). Scale score range from 0 (limited none of the time) to 100 (limited all of the time) and represent the reported amount of time in the prior two weeks respondents were limited on-the-job. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 52 patients were evaluable for WLQ at week 4.|||Scores||Standard Deviation|Mean
2598101|NCT02191137|Secondary|Percentage of Patients With an MCID From Week 16 in Emotional Dimension Score at Week 24 (Completers Analysis Set Only)|For the physical and emotional dimension scores, the MCID was a 4-point decrease.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH emotional dimension score at Week 24.|||Percentage of Participants|||Number
2598102|NCT02191137|Secondary|Percentage of Patients With an MCID From Week 16 in Physical Dimension Score at Week 24 (Completers Analysis Set Only)|For the physical and emotional dimension scores, the MCID was a 4-point decrease.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients were evaluable for LPH physical dimension score at week 24.|||Percentage of Participants|||Number
2598103|NCT02191137|Secondary|Percentage of Patients With an MCID From Week 16 in LPH Total Score at Week 24 (Completers Analysis Set Only)|For LPH total score, the MCID was an 11-point decrease.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH total score at Week 24.|||Percentage of Participants|||Number
2598104|NCT02191137|Secondary|Percentage of Patients With an MCID From Baseline in LPH Emotional Dimension Score at Weeks 4, 16, and 24|"For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH emotional dimension score at week 4.|||Percentage of Participants|||Number
2598105|NCT02191137|Secondary|Percentage of Patients With an MCID From Baseline in LPH Physical Dimension Score at Weeks 4, 16, and 24|"For the physical and emotional dimension scores, the MCID was a 4-point decrease. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH physical dimension score at week 4.|||Percentage of Participants|||Number
2598106|NCT02191137|Secondary|Percentage of Patients With a Minimal Clinically Significant Important Difference (MCID) From Baseline in LPH Total Score at Weeks 4, 16, and 24|"For LPH total score, the MCID was an 11-point decrease from baseline. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH total score at week 4.|||Percentage of participants|||Number
2598107|NCT02191137|Secondary|Change From Week 16 to Week 24 in the LPH Emotional Dimension Score (Completers Analysis Set Only)|The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH emotional dimension score at Week 24.|||Scores||Standard Deviation|Mean
2598108|NCT02191137|Secondary|Change From Baseline to Weeks 4, 16, and 24 in the LPH Emotional Dimension Score|"The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4, Week 16 and Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 75 patients were evaluable for LPH emotional dimension score at week 16 or before.|||Scores||Standard Deviation|Mean
2609034|NCT02071095|Secondary|CD8 CD38 (Mean of Fluorescence)|the CD38-activation marker on CD8 T-cells (CD8/CD38).|Day 8||||mean fluorescent intensity (MFI)||Standard Deviation|Mean
2598109|NCT02191137|Secondary|Change From Week 16 to Week 24 in the LPH Physical Dimension Score (Completers Analysis Set Only)|The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 57 patients in Completer analysis set were evaluable for LPH physical dimension score at Week 24.|||Scores||Standard Deviation|Mean
2598110|NCT02191137|Secondary|Change From Baseline to Weeks 4, 16, and 24 in the LPH Physical Dimension Score|"The LPH derived from the Minnesota Living with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 to 105 is calculated by summing the responses to all 21 questions. A physical dimension score (range 0-40, 8 items) and an emotional dimension score (range 0-25, 5 items) can also be calculated. For all LPH scores, a higher score indicates that patients are more affected by their medical condition. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Weeks 4, 16, and 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 75 patients were evaluable for LPH physical dimension score at week 16 or before.|||Scores||Standard Deviation|Mean
2598111|NCT02191137|Secondary|Change From Week 16 to Week 24 in the LPH Total Score (Completers Analysis Set Only)|The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions.|Week 16 to Week 24|The Completers analysis set included patients valid for Safety/ITT analysis sets who had an LPH score at baseline (Visit 1), Week 4, Week 16, and Week 24. 58 patients in Completer analysis set were evaluable for LPH total score at Week 24.|||Scores||Standard Deviation|Mean
2598112|NCT02191137|Secondary|Change From Baseline to Weeks 4 and 16 in the LPH Total Score|"The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions. In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint."|Baseline to Week 4 and Week 16|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 72 patients were evaluable for LPH total score at Week 4.|||Scores||Standard Deviation|Mean
2598113|NCT02191137|Primary|Change From Baseline to Week 24 in the Living With Pulmonary Hypertension (LPH) Questionnaire Total Score|The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions.|Baseline to Week 24|The ITT analysis set was synonymous with the Safety analysis set definition which included all patients who received at least 1 dose of test drug. 66 patients were evaluable for LPH total score at Week 24.|||Scores||Standard Deviation|Mean
2598114|NCT02191046|Secondary|the Contamination in Nasal Irrigation Devices|compare the result of bacterial culture in both group of nasal irrigation devices. We reported in the following item; no growth, gram positive or gram negative or mixed organism|at second week after treatment|||||||
2598115|NCT02191046|Primary|the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children|For 5S-score, we measured the the mean 5-s score of both group at 2 weeks compare to the mean 5-s score at baseline visit and compare 5S-score between group at 2 weeks. The S5- score is a scale assessing severity of sinusitis. It compose of the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.It range from 0 (best possible outcome) to 15(worst possible outcome). 7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent). For satisfaction, we reported the result in the term of 7 points Likert scale and compare these scale between group at 2 weeks after treatment|compare 5S-score of both group at 2 week and at baseline visit .compare the mean 5S-score and satisfaction score between both group at 2 weeks after treatment|The S5- score is the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent).|||units on a scale||Standard Deviation|Mean
2598116|NCT02191033|Secondary|Smoking Abstinence|biochemically confirmed point prevalence of self reported past 7-day abstinence|6- and 12- weeks||||Participants|||Count of Participants
2598117|NCT02191033|Primary|Study Retention- Number of Participants Who Attend the 6- and 12-week Follow up Visits.|We will determine the number of enrolled participants who follow up at the 6- and 12- week follow up visit.|6- and 12- weeks||||Participants|||Count of Participants
2598118|NCT02191033|Primary|Study Enrollment- Number of Participants Who Join the Study|We will report the number of persons who join the study.|baseline||||Participants|||Count of Participants
2598119|NCT02190903|Primary|Number of Participants With Postoperative Delirium After Hip Fracture Surgery|Delirium will be assessed by the Confusion Assessment Method Instrument (CAM), a validated method of assessing delirium based on the presence of both (1) an acute onset of signs and symptoms with a fluctuating course AND (2) inattention; PLUS (3) disorganized thinking OR (4) an altered level of consciousness.|Up to 5 days post hip fracture surgery||||Participants|||Count of Participants
2598120|NCT02190721|Secondary|Participants With Febrile Neutropenia During the First Cycle of Chemotherapy|Febrile neutropenia was defined as an axillary or external ear temperature >38.3°C (100.94°F) or 2 consecutive readings >37.8°C (100.04°F) at least 2 hours apart and an ANC <0.5 * 10^9/L. The efficacy variable was evaluated for up to 21 days from the start of the first cycle of chemotherapy.|(relative to tbo-filgrastim therapy) Days -7 to Day 14|Full analysis set|||Participants|||Count of Participants
2598126|NCT02190721|Secondary|Time to ANC Recovery To ≥1.0 * 10^9/L From ANC Nadir||ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||days||Standard Deviation|Mean
2598127|NCT02190721|Secondary|Time to Absolute Neutrophil Count (ANC) Nadir From Beginning of Chemotherapy||ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||days||Standard Deviation|Mean
2598128|NCT02190721|Secondary|Time to Absolute Neutrophil Count (ANC) Nadir From Beginning of Tbo-filgrastim Administration||ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||days||Standard Deviation|Mean
2598129|NCT02190721|Secondary|Absolute Neutrophil Count (ANC) Nadir|ANC nadir (measured in 10^9/L) is the lowest ANC recorded.|ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||*10^9/L||Standard Deviation|Mean
2598130|NCT02190721|Secondary|Area Under The Serum Drug Concentration By Time Curve Of Absolute Neutrophil Count (AUC ANC)||ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||*10^9/L * days||Standard Deviation|Mean
2598131|NCT02190721|Secondary|Duration of Severe Neutropenia|The duration of severe neutropenia was derived by counting the number of days with absolute neutrophil count (ANC) values <0.5 * 10^9/L.|ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|Full analysis set|||days||Standard Deviation|Mean
2598132|NCT02190721|Secondary|Participants With Severe Neutropenia|Count of participants who had an incidence of severe neutropenia, defined as any value of absolute neutrophil count (ANC) <0.5 * 10^9/L at any time.|ANC blood samples collected within 1 hour before the tbo-filgrastim dose on Day 1, and on Days 5, 6, 7, 10, 12, 15 and at the end of study visit (up to Day 21)|The Full Analysis Set (FAS) included all patients in the ITT population who received at least 1 dose of tbo-filgrastim and had at least 1 post baseline efficacy assessment.|||Participants|||Count of Participants
2598133|NCT02190721|Secondary|Terminal Elimination Rate (Lambda-z)||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1|PK analysis set. The 12 hour sampling duration limited the ability to characterize the terminal elimination rate of tbo-filgrastim (λz ) and related parameters (t½, AUC0-∞,-∞ %AUCex, CL/F, and Vz/F) for more than half of patients enrolled, especially those with maximum serum concentrations being achieved >= 6 hours. This included both infants.|||1/hr||Standard Deviation|Mean
2598134|NCT02190721|Secondary|Percentage of the AUC0-∞ That Is Due To the Extrapolation (%AUCext)||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1|PK analysis set. The 12 hour sampling duration limited the ability to characterize the terminal elimination rate of tbo-filgrastim (λz ) and related parameters (t½, AUC0-∞,-∞ %AUCex, CL/F, and Vz/F) for more than half of patients enrolled, especially those with maximum serum concentrations being achieved >= 6 hours. This included both infants.|||percent of AUC0–∞||Standard Deviation|Mean
2598135|NCT02190721|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vz/F)||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1|PK analysis set. The 12 hour sampling duration limited the ability to characterize the terminal elimination rate of tbo-filgrastim (λz ) and related parameters (t½, AUC0-∞,-∞ %AUCex, CL/F, and Vz/F) for more than half of patients enrolled, especially those with maximum serum concentrations being achieved >= 6 hours. This included both infants.|||liters||Standard Deviation|Mean
2598136|NCT02190721|Secondary|Apparent Clearance (CL/F)||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose of Day 1|PK analysis set. The 12 hour sampling duration limited the ability to characterize the terminal elimination rate of tbo-filgrastim (λz ) and related parameters (t½, AUC0-∞,-∞ %AUCex, CL/F, and Vz/F) for more than half of patients enrolled, especially those with maximum serum concentrations being achieved >= 6 hours. This included both infants.|||L/hour||Standard Deviation|Mean
2598137|NCT02190721|Secondary|Elimination Half-life (t1/2)||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1|PK analysis set. The 12 hour sampling duration limited the ability to characterize the terminal elimination rate of tbo-filgrastim (λz ) and related parameters (t½, AUC0-∞,-∞ %AUCex, CL/F, and Vz/F) for more than half of patients enrolled, especially those with maximum serum concentrations being achieved >= 6 hours. This included both infants.|||hours||Standard Deviation|Mean
2598138|NCT02190721|Secondary|AUC From Time 0 to Infinity (AUC0-inf)||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1|PK analysis set. The 12 hour sampling duration limited the ability to characterize the terminal elimination rate of tbo-filgrastim (λz ) and related parameters (t½, AUC0-∞,-∞ %AUCex, CL/F, and Vz/F) for more than half of patients enrolled, especially those with maximum serum concentrations being achieved >= 6 hours. This included both infants.|||hr*pg/mL||Standard Deviation|Mean
2598139|NCT02190721|Secondary|Area Under The Serum Concentration-Time Curve From Time 0 To 12 Hours Postdose (AUC0-12)||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1|PK analysis set. In 4 participants, serum concentrations of tbo-filgrastim were not obtained through 12 hours and as a result, AUC0-12 could not be calculated.|||hr*pg/mL||Standard Deviation|Mean
2598140|NCT02190721|Secondary|Area Under The Serum Concentration-Time Curve From Time 0 To Time Of Last Quantifiable Concentration (AUClast)||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1|PK analysis set|||hr*pg/mL||Standard Deviation|Mean
2598141|NCT02190721|Secondary|Time to Maximum Observed Serum Concentration (Tmax) of Tbo-Filgrastim||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1|PK analysis set|||Hours||Full Range|Median
2598142|NCT02190721|Secondary|Maximum Observed Serum Concentration (Cmax) of Tbo-Filgrastim||Within 1 hour before the tbo-filgrastim dose and at 2, 4, 6, 8, and 12 hours after the tbo-filgrastim dose on Day 1|Pharmacokinetic (PK) analysis set|||pg/mL||Standard Deviation|Mean
2598143|NCT02190721|Secondary|Participants With Positive Immunogenicity Findings Tested at Four Study Timepoints|"Blood was drawn for the assessment of anti-drug antibody (ADA) at screening, at the end-of-study visit, and at 30 and 90 days after the last administration of tbo-filgrastim in chemotherapy (CTX) cycle 1.~The main endpoint from the assessment was the presence of antibodies in the sample, reported as positive or negative. Participants with positive results are summarized."|Baseline (Day -21), Day 21 (end of study visit), Day 51 (30 Day follow-up) and Day 111 (90 Day follow-up)|Safety analysis set|||Participants|||Count of Participants
2598144|NCT02190721|Primary|Participants Who Were Alive at the 90 Day Follow-Up|Summary of participant survival at 90 day follow-up.|90 days post end of study visit (111 days from start of tbo-filgrastim administration)|Safety analysis set|||Participants|||Count of Participants
2598145|NCT02190721|Primary|Participants With Negative Shifts From Baseline to End of Study in Spleen Sonography Findings|"The investigator assessed spleen sonography findings as normal, abnormal not clinically significant, or abnormal clinically significant.~Data representing counts of participants with a negative shift from baseline in spleen sonography findings (including shifts from normal to abnormal, not clinically significant) are presented."|Baseline: Day -21, Day 21 (end of study visit)|Safety analysis set|||Participants|||Count of Participants
2598146|NCT02190721|Primary|Participants With Injection Site Reactions to Tbo-Filgrastim Administration|Using Local Tolerability Assessment Scale ranging from Pain severity 0 (Absent) to 3 (Spontaneously painful)|Day 1 (start of tbo-filgrastim administration) up to Day 14|Safety analysis set|||Participants|||Count of Participants
2598147|NCT02190721|Primary|Participants With Negative Shifts From Baseline to End of Study in Physical Exam Findings|"Physical examination was performed at screening and at the end-of-study visit. The following body systems were marked as normal or abnormal and if abnormal, whether clinically significant: Head, ears, eyes, nose and throat (HEENT), chest and lungs, heart, abdomen, skin, lymph nodes and neurological.~Any physical examination finding that is judged by the investigator as a clinically significant change (worsening) compared with a baseline value were considered as an adverse event.~Counts of participants with a negative shift from baseline in any of the body systems (including shifts from normal to abnormal, not clinically significant) are presented."|Baseline: Day -21, Day 21 (end of study visit)|Safety analysis set|||Participants|||Count of Participants
2598148|NCT02190721|Primary|Participants With Potentially Clinically Significant Abnormal Electrocardiogram Results|"Triplicate 12-lead ECGs were conducted at screening, predose, 4 and 6 hours postdose on day 1 of tbo-filgrastim administration, and at the end-of-study visit. The ECGs were interpreted by both the investigator and a qualified physician at the central diagnostic center as normal, abnormal not clinically significant, or abnormal clinically significant. The following parameters were measured/derived for each ECG assessment: heart rate, PR interval, RR interval, QT interval, corrected QT interval according to Fridericia's formula (QTcF), corrected QT interval according to Bazett's formula (QTcB), QRS duration, and QRS axis.~The count of participants with potentially clinically significant ECG findings is reported."|Day 1 (start of tbo-filgrastim administration) pre-dose, 4 hours post dose and 6 hours post dose; Day 21 (end of study visit)|Safety analysis set|||Participants|||Count of Participants
2598149|NCT02190721|Primary|Participants With Potentially Clinically Significant Abnormal Vital Signs|"Vital sign tests included Pulse Rate (bpm), Systolic BP (mmHg), Diastolic BP (mmHg), Respiratory Rate (bpm), and Temperature (°C).~Only tests with potentially clinically significant abnormal results are reported."|Day 1 (start of tbo-filgrastim administration) up to Day 21|Safety analysis set|||Participants|||Count of Participants
2598150|NCT02190721|Primary|Participants With Potentially Clinically Significant Abnormal Hematology Results|"Hematology tests included Basophils ABS (x 10^9/L), Basophils (%), Eosinophils ABS (x 10^9/L), Eosinophils (%), Hematocrit (%), Hemoglobin (g/L), Lymphocytes Absolute Count (ABS) (x 10^9/L), Lymphocytes (%), Monocytes ABS (x 10^9/L), Monocytes (%), Neutrophils ABS (x 10^9/L), Neutrophils (%), Platelets (x 10^9/L), Red Blood Cell (RBC) (x 10^12/L), White Blood Cell (WBC) (x 10^9/L).~Only tests with potentially clinically significant abnormal results are reported.~ULN = upper limit of normal"|Day 1 (start of tbo-filgrastim administration) up to Day 21|Safety analysis set|||Participants|||Count of Participants
2598151|NCT02190721|Primary|Participants With Potentially Clinically Significant Abnormal Serum Chemistry Results|"Serum chemistry tests included alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), direct bilirubin, indirect bilirubin, total bilirubin, calcium, creatinine, gammaglutamyl transpeptidase (GGT), glucose, potassium, lactate dehydrogenase (LDH), phosphate, sodium and uric acid.~Only tests with potentially clinically significant abnormal results are reported.~ULN = upper limit of normal"|Day 1 (start of tbo-filgrastim administration) up to Day 21|Safety analysis set|||Participants|||Count of Participants
2598152|NCT02190721|Primary|Participants With Adverse Events (AEs)|"An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. A treatment-emergent AE (TEAE) is an AE occurring during the timeframe. A non-TEAE is any AE not considered a TEAE.~Severity was rated by the investigator using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) scale where 3=severe but not life-threatening, 4=life-threatening and 5=death. Relation of AE to treatment was determined by the investigator (related=reasonable possibility). Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes."|Non-TEAE: signing of informed consent to Day -1 (last day of CTX in week 1). And > 30 days after last dose of tbo-filgrastim (Day 46+). TEAE timeframe: Day 1 (start of tbo-filgrastim) to <= 30 days after the last dose (up to Day 45)|Safety analysis set. The safety analysis set included all enrolled patients who received at least 1 dose of tbofilgrastim.|||Participants|||Count of Participants
2598153|NCT02190604|Secondary|Part 2: CLr in Healthy Volunteers|Pharmacokinetics of QBW251 in urine: renal clearance following drug administration. In this analysis CLr will be reported using urine samples taken on Day 1 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1; Day 14 was calculated as urine was only collected up to 12 hours on Day 1 thus CLr cannot be calculated.|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||L/hr||Standard Deviation|Mean
2598154|NCT02190604|Secondary|Part 2: Ae0-t in Healthy Volunteers|Pharmacokinetics of QBW251 in urine: amount of drug excreted in urine from time zero until last measurable concentration. In this analysis Ae0-t will be reported using urine samples taken on Day 1 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||L/hr||Standard Deviation|Mean
2598155|NCT02190604|Secondary|Part 3: Time to Maximum Concentration (Tmax)|Pharmacokinetics of QBW251 in plasma after multiple doses: time to reach the maximum concentration after administration of QBW251. In this analysis Tmax will be reported using blood samples taken on Days 1 and 14 in patients|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||hr||Standard Deviation|Mean
2598156|NCT02190604|Secondary|Part 3: Tlast in CF Patients|Blood samples were collected at timepoints prespecified in the study protocol. Tlast of QBW251 was the last time point when blood sample collected was quantifiable day 1 and day 14|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||hr||Standard Deviation|Mean
2598157|NCT02190604|Secondary|Part 3: Maximum Concentration (Cmax) in CF Patients|Observed maximum plasma concentration following administration of QBW251. In this analysis Cmax will be reported using blood samples taken on Day 1and day 14 from patients|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||ng/mL||Standard Deviation|Mean
2598158|NCT02190604|Secondary|Part 3: Plasma Concentration at the Last Quantifiable Time Point (Clast) of QBW251 in CF Patients|Blood samples were collected at timepoints prespecified in the study protocol. Tlast of QBW251 was the last time point when blood sample collected was quantifiable|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day2|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||ng/mL||Standard Deviation|Mean
2598159|NCT02190604|Secondary|Part 3: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of QBW251 in CF Patients|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||ng × hr /mL||Standard Deviation|Mean
2598160|NCT02190604|Secondary|Part 2: T1/2 in Healthy Volunteers|terminal elimination half-life (T1/2). In this analysis T1/2 will be reported using blood samples taken on Day 14 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||hr||Standard Deviation|Mean
2598161|NCT02190604|Secondary|Part 2: Racc in Healthy Volunteers|Accumulation ratio (Racc). In this analysis Racc will be reported using blood samples taken on Days 1 - 14 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 - 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||Ratio||Standard Deviation|Mean
2598162|NCT02190604|Secondary|Part 2: Vz/F in Healthy Volunteers|Apparent volume of distribution during the terminal elimination phase following extravascular administration. In this analysis Vz/F will be reported using blood samples taken on Day 14 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||Liters||Standard Deviation|Mean
2598163|NCT02190604|Secondary|Part 2: CL/F in Healthy Volunteers|apparent systemic clearance from plasma following extravascular administration. In this analysis CL/F will be reported using blood samples taken on Day 14 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||L/hr||Standard Deviation|Mean
2598164|NCT02190604|Secondary|Part 2: Cav in Healthy Volunteers|The average drug concentration in plasma during multiple dosing. In this analysis Cav will be reported using blood samples taken on Days 1 and 14 are from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||ug/L||Standard Deviation|Mean
2599931|NCT02169219|Secondary|Severe Flares|Number of severe flares defined as flare with BVAS/WG > 3 or experiencing one of the major BVAS/WG items|6 months||||Participants|||Count of Participants
2598165|NCT02190604|Secondary|Part 2: AUC0-t|Pharmacokinetics of QBW251 in plasma: area under the plasma concentration versus time curve from time zero to time of last measurable concentration. In this analysis AUC0-t will be reported using blood samples taken on Day 14 are from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)||||hr*ng/mL||Standard Deviation|Mean
2598166|NCT02190604|Secondary|Part 2: Time to Maximum Concentration (Tmax) in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma after multiple doses: time to reach the maximum concentration after administration of QBW251. In this analysis Tmax will be reported using blood samples taken on Days 1 and 14 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||hr||Standard Deviation|Mean
2598167|NCT02190604|Secondary|Part 2: Maximum Concentration (Cmax) in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma after multiple doses: observed maximum plasma concentration following QBW251 at steady state. In this analysis Cmax will be reported using blood samples taken on Days 1 and 14 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||ug/L||Standard Deviation|Mean
2598168|NCT02190604|Secondary|Part 2: AUCtau in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma after multiple doses: the area under the plasma concentration-time curve from time zero to end of the dosing interval tau. In this analysis AUCtau will be reported. Samples taken on Days 1 and 14 from healthy volunteers|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)|Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||hr*ng/mL||Standard Deviation|Mean
2598169|NCT02190604|Secondary|Part 1: Vz/F in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: apparent volume of distribution during the terminal elimination phase following extravascular administration. In this analysis Vz/F will be reported using blood samples taken on Days 1 - 5 from healthy volunteers.|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||Liters||Standard Deviation|Mean
2598170|NCT02190604|Secondary|Part 1: CL/F in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: apparent systemic clearance from plasma following extravascular administration. In this analysis CL/F will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the CL/F goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered)|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||L/hr||Standard Deviation|Mean
2598171|NCT02190604|Secondary|Part 1: AUCinf in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: area under the plasma concentration time curve from time zero to infinity. In this analysis AUCinf will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the AUCinf goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered)|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||hr*ng/mL||Standard Deviation|Mean
2598172|NCT02190604|Secondary|Part 1: T1/2 in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: terminal elimination half-life. In this analysis T1/2 will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the T1/2 goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered).|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||hr||Standard Deviation|Mean
2598173|NCT02190604|Secondary|Part 1: Time to Maximum Concentration (Tmax) in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: time to reach the maximum concentration after administration of QBW251. In this analysis Tmax will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In this part of the study a single dose was administered and samples were collected up to 5 days. As a result the Tmax is one value as the concentration-time curve goes to Day 5 (for some lower does QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered).|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||hr||Standard Deviation|Mean
2599932|NCT02169219|Secondary|Limited Flares|Number of limited flares defined as a new occurrence or worsening of one or more minor BVAS/WG items and a total BVAS/WG ≤ 3|6 months||||Participants|||Count of Participants
2598174|NCT02190604|Secondary|Part 1: Maximum Concentration (Cmax) in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: observed maximum plasma concentration following administration of QBW251. In this analysis Cmax will be reported using blood samples taken on Days 1- 5 are from healthy volunteers|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis|||ug/L||Standard Deviation|Mean
2598175|NCT02190604|Secondary|Part 1: AUC0-t in Healthy Volunteers|Pharmacokinetics of QBW251 in plasma: area under the plasma concentration versus time curve from time zero to time of last measurable concentration (AUC0-t). In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the AUC0-t goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered)|Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 2-5)|All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis.|||hr*ng/mL||Standard Deviation|Mean
2598176|NCT02190604|Secondary|Part 3: Change in Cystic Fibrosis Questionnaire-Revised Reported Outcomes|Change in Cystic Fibrosis Questionnaire data will be obtained from patient reported outcomes (CFQ-R PRO). Respiratory Domain, cores range from 0 to 100, with higher scores indicating better health, a change of 4 is considered clinically relevant|Baseline and Day 14|Pharmacodynamics (PD) analysis set: All randomized patients were included in the PD analysis|||Units on a scale||Standard Error|Least Squares Mean
2598177|NCT02190604|Secondary|Part 3:Change in Forced Expiratory Volume in 1 Second (FEV1) at Day 15|Forced Expiratory Volume in 1 second (FEV1) will be measured via spirometer according to international standards. Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation|Baseline and Day 15|Pharmacodynamics (PD) analysis set: All randomized patients were included in the PD analysis|||Liters||Standard Error|Least Squares Mean
2598178|NCT02190604|Primary|Part 3: Number of Participants (Patients) With Reported Adverse Events Receiving QBW251|All adverse events and serious adverse events (in patients) reported.|Day 1 to Day 56|Safety analysis set: All randomized patients were included in the safety analysis|||Participants|||Number
2598179|NCT02190604|Primary|Part 3: Change in Lung Clearance Index (LCI) From Baseline to Day 15|Change in Lung Clearance Index (LCI) will be conducted according to international standards in cystic fibrosis patients. Lung clearance index (LCI) is a measure of ventilation inhomogeneity that is derived from a multiple-breath washout test, A reduction in mean change from baseline for LCI2.5 indicates improvement.|Baseline and Day 15|Pharmacodynamics (PD) analysis set: All randomized patients were included in the PD analysis|||Ratio||Standard Deviation|Mean
2598180|NCT02190604|Primary|Part 1 and 2:Number of Participants (Healthy Volunteers) With Reported Adverse Events Receiving QBW251|All adverse events (in healthy volunteers) reported.|Day 1 to Day 36|All treated subjects were included in the data analysis. Subjects were analyzed according to the study treatment(s) received.|||Participants|||Number
2598181|NCT02190591|Other Pre-specified|Third and Fourth Degree Lacerations|Measuring if use of the Peanut Labor Ball impacts third and fourth degree lacerations during delivery|within the last 15-30 minutes of birth|participants with vaginal delivery only|||Participants|||Count of Participants
2598182|NCT02190591|Secondary|Dilation to Second Stage Labor|Examining if use of the peanut labor ball has an effect on time between administration of epidural to complete dilation|thirty minutes after epidural given to birth of baby|Included participants with vaginal delivery only|||minutes||Standard Deviation|Mean
2598183|NCT02190591|Primary|Delivery Rate|Rate of patients who deliver by cesarean section|.5-72 hours||||participants|||Number
2598184|NCT02190552|Secondary|Evidence of Infarction|Infarction, of a previously uninvolved vascular territory, as evaluated from 24hr Computed Tomography imaging by the Angiography Core lab.|24(-8/+12) hours Post Procedure|Data were not collected||||||
2598185|NCT02190552|Secondary|Rate of New Territory Embolization|Embolization, or thrombus dislocation, into a previously uninvolved vascular territory as evaluated from angiographic images by the Angiography Core Lab and the Data Safety Monitoring Board.|24(-8/+12) hours Post Procedure|Data were not collected||||||
2598186|NCT02190552|Secondary|Clinical Outcome at 90 Days|"A good clinical outcome will be judged to be a mRS score of ≤2 at 90(±14) days.~mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. mRS scores range from 0 to 6:~mRS 0 = No symptoms.~mRS 1 = No significant disability.~mRS 2 = Slight disability.~mRS 3 = Moderate disability.~mRS 4 = Moderately severe disability.~mRS 5 = Severe disability.~mRS 6 = Dead."|90(±14) days Post Procedure|Data was not collected for all participants.|||Participants|||Count of Participants
2598187|NCT02190552|Secondary|Symptomatic ICH|"Symptomatic ICH rate within 24 hours (range: 16 to 36 hours) post-procedure. Symptomatic intracranial haemorrhage (parenchymatous haemorrhage type 2), at post-treatment scan combined with neurological deterioration (C2) leading to an increase of 4 points or more on the NIH Stroke Scale.~The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment."|24(-8/+12) hours Post Procedure||||Participants|||Count of Participants
2598188|NCT02190552|Secondary|Serious Adverse Device Related Effects (SADE)|SADE is defined as vessel perforation or vessel dissection, which is attributable to the Neuravi device, or where the Neuravi device cannot be ruled out as the cause.|24(-8/+12) hours Post Procedure||||Participants|||Count of Participants
2598189|NCT02190552|Secondary|Mortality Post Procedure|All procedure related mortality (i.e. directly traceable to a procedure related SAE).|7 and 90(±14) days post procedure||||Participants|||Count of Participants
2598190|NCT02190552|Secondary|Time to Revascularization|Defined as time from groin puncture to visualization of final angiographic result.|Day 1||||minutes||Standard Deviation|Mean
2598191|NCT02190552|Primary|Proportion of Revascularisation Following the Use of the Neuravi Device.|"Revascularisation is defined as achieving a modified Thrombolysis in Cerebrovascular Infarction (mTICI) score of 2b or greater.~mTICI is a 6-point grading system for determining the response of thrombolytic therapy for ischaemic stroke:~mTICI 0 = No perfusion~mTICI 1 = Penetration but not perfusion~mTICI 2a = Some perfusion with distal branch filling of <50% of territory visualized~mTICI 2b = Substantial perfusion with distal branch filling of ≥50% of territory visualized~mTICI 2c = Near-complete perfusion~mTICI 3 = Complete perfusion"|Day 1||||Participants|||Count of Participants
2598192|NCT02190435|Secondary|Radiation Exposure|Intraoperative fluoroscopy exposure time for lag screw placement (seconds)|Intraoperative||||seconds||Standard Deviation|Mean
2598193|NCT02190435|Primary|Tip-to-apex Distance|Distance between lag screw tip and head surface as measured on the ADAPT system|Intraoperative||||mm||Standard Deviation|Mean
2598194|NCT02190279|Secondary|Detectability of Suspicious Tumors Based on Prostate Specific-Antigen (PSA) Levels in the Biochemical Recurrence Group|Visualizing positive lesions as a function of PSA value. Undetectable PSA is normal in this population.|3 months|1 patient had technical issues and was not included in the final analysis.|||percent of tumors identified|||Number
2598195|NCT02190279|Secondary|Detectability of Suspicious Prostate Cancer Lesions in Suspected Localized Prostate Cancer Patients With Prostate Gland|Visualizing positive lesions with DCFBC and mpMRI.|3 months|3 patients were excluded from analysis, because of prior focal laser ablation therapy (n=1), prior brachytherapy (n=1), and lack of histopathology confirmation tissue (n=1). The Biochemical Recurrence and Known Metastatic Disease Arms/Groups are not applicable for this outcome measure, thus are not represented here.|||percent of lesions identified|lesions||Number
2598196|NCT02190279|Secondary|Median Tumor Foci Size in Suspected Localized Prostate Cancer Patients Undergoing Prostatectomy|Tissue was obtained and stained with hematoxylin-eosin. The resulting whole mount specimens were correlated with MRI and PET/CT imaging. For each dominant/index tumor (largest tumor with highest Gleason score) was determined.|1 month|3 patients were excluded from analysis, because of prior focal laser ablation therapy (n=1), prior brachytherapy (n=1), and lack of histopathology confirmation tissue (n=1). The Biochemical Recurrence and Known Metastatic Disease Arms/Groups are not applicable for this outcome measure, thus are not represented here.|||cm|Tumor foci|Full Range|Median
2598197|NCT02190279|Secondary|Average Standardized Uptake Value (SUVmax) for Primary Prostate Cancer Patients Compared to Benign Prostatic Hyperplasia (BPH)|Primary prostate cancer was compared to BPH nodules and normal prostate tissue using a one-way analysis of variance (Anova). Negative uptake is defined as tumor uptake less than adjacent background soft tissue, or blood pool for lymph nodes.|1 hour and 2 hour post injection (p.i.)|3 patients were excluded from analysis due to prior focal ablation therapy (1), prior brachytherapy (1), and lack of histopathologic confirmation tissue. The Biochemical Recurrence and Known Metastatic Disease Arms/Groups are not applicable for this outcome measure, thus are not represented here.|||standardized uptake value (SUV)||Standard Deviation|Mean
2598198|NCT02190279|Secondary|Number of Detectable Lesions in Bone With Respect to 18F-DCFBC Imaging and/or Na18F Positron Emission Tomography (PET)/Computed Tomography (CT) in Patients With Known Metastatic Disease|18F-DFBC and conventional imaging was used to identify positive lesions in bone.|3 months|The Suspected Localized Prostate Cancer and Biochemical Recurrence Arms/Groups are not applicable for this outcome measure, thus are not represented here. Data was collected for 31 participants but only 28 had data evaluable for final analysis in the Known Metastatic Group.|||number of bone lesions|lesions||Number
2598199|NCT02190279|Secondary|Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 42 months and 21 days||||Participants|||Count of Participants
2598200|NCT02190279|Primary|Number of Lesions Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC)|Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered a positive lesion for prostate cancer.The measure would be compared with other imaging or pathology.|1 hour and 2 hour timepoints at baseline|"In Arm 1: 3 patients were excluded from analysis due to prior focal ablation therapy (1), prior brachytherapy (1), and lack of histopathologic confirmation tissue.~Arm 2: 1 patient had technical issues and was not included in the final analysis Arm 3: 2 patients were not imaged and 1 patient withdrew consent"|||lesions|||Number
2598201|NCT02190279|Primary|Number of Participants With Local Recurrence, Lymph Node Metastases or Distant Metastatic Sites Detected by N-[N-[(S)-1,3-dicarboxypropyl]Carbamoyl]-4-(18)F-fluorobenzyl-L-cysteine ((18)F-DCFBC) Imaging|Any abnormal focus of 18F-DCFBC uptake higher than the surrounding background and not associated with physiological uptake was considered positive for prostate cancer, and each was classified as local recurrence, lymph node metastases or distant metastatic sites.|1 hour and 2 hour timepoints at baseline|"In Arm 1: 3 patients were excluded from analysis due to prior focal ablation therapy (1), prior brachytherapy (1), and lack of histopathologic confirmation tissue.~Arm 2: 1 patient had technical issues and was not included in the final analysis Arm 3: 2 patients were not imaged and 1 patient withdrew consent"|||Participants|||Count of Participants
2598202|NCT02190045|Secondary|Modified Mini- Mental Exam||8 weeks|||||||
2598203|NCT02190045|Secondary|Activities Specific Balance Confidence Scale||8 weeks|||||||
2598204|NCT02190045|Secondary|Functional Status Measures||8 weeks|||||||
2598205|NCT02190045|Secondary|Quality of Life (SF-36)||8 weeks|||||||
2598247|NCT02189252|Secondary|Baseline-adjusted Cmax for Plasma Total DHA||This is a crossover study with two treatment periods. The estimated treatment effects were based on the within-subject comparison between the two treatments, each having a 4-week duration and a 4-week wash off period in between.|PK Population|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2598206|NCT02190045|Primary|Berg Balance Scale|"The primary efficacy outcome was the Berg Balance Scale (BBS), which assesses balance impairments in older adults and is a good measure of static and dynamic stability. It consists of 14 tasks performed in a standardized order with each task scored on a five-point scale according to quality or time ranging from 0 (lowest level of function) to 4 (highest level). The maximum score is 56. BBS has an excellent inter-rater reliability (0.98). A change of four points is considered the minimally detectable change for community dwelling older adults that ambulate without an assistive device."|8 weeks||||units on a scale||Standard Deviation|Mean
2598207|NCT02189954|Secondary|Postoperative Pharyngolaryngeal Morbidity at Postoperative 24.Hour|The primer outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 24.hour|Postoperative 24.hour|Chi Square Test for categorical variables, for constant variables t test when suitable for normal distribution and when unsuitable for normal distrubition Mann Whitney U have been used for analysis. p < 0.05 was considered significant.|||units on a scale||Full Range|Median
2598208|NCT02189954|Primary|Postoperative Pharyngolaryngeal Morbidity Postoperative 1.Hour|The primary outcome was a composite endpoint of any pharyngolaryngeal complications such as sore throat, dysphonia and dysphagia according to Likert scale ranges from 1 (none) to 4 (severe) at postoperative 1.hour|Postoperative 1.hour||||units on a scale||Full Range|Median
2598209|NCT02189941|Secondary|Safety and Tolerability of Deferiprone Sustained Release Tablets|The number of participants who experienced adverse events between the time of dosing up to 24 hours post-dose, including any changes of clinical significance in vital signs, 12-lead ECG, and clinical laboratory tests|From time of dose until 24 hours post dose|All subjects who received at least one dose of study medication and had at least one safety assessment|||participants|||Number
2598210|NCT02189941|Primary|Thalf for Serum Deferiprone and Deferiprone 3-O-glucuronide|Thalf (the apparent terminal elimination half-life of the drug) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data|||h||Standard Deviation|Mean
2598211|NCT02189941|Primary|Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Tmax (the time to Cmax) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data|||h||Standard Deviation|Mean
2598212|NCT02189941|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax (maximum concentration in the serum) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data|||mcg/mL||Standard Deviation|Mean
2598213|NCT02189941|Primary|AUCinf for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUCinf (Area Under the Curve to infinity) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data|||mcg*h/mL||Standard Deviation|Mean
2598214|NCT02189941|Primary|AUCt for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUCt (Area Under the Curve to the last measured time) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.5, 0.75, 1, 1.3333, 1.6667, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16 and 24 hours post-dose.|24-hour interval|All subjects who contributed evaluable pharmacokinetics data|||mcg*h/mL||Standard Deviation|Mean
2598215|NCT02189915|Secondary|Phosphocreatine Levels Measured by Magnetic Resonance Spectroscopy|Phosphocreatine (PCr) was measured pre- and post-creatine treatment to assess changes in neurochemistry. Creatine treatment may increase brain intracellular PCr, and brain energy metabolism has been suggested to play a role in the pathophysiology of depression. Increased levels of PCr suggest reduced depressive symptoms. PCr levels are calculated using a ratio and remains unitless.|8 weeks||||Phosphocreatine levels (unitless)||Standard Deviation|Mean
2598216|NCT02189915|Primary|Depression Rating Scores|Hamilton Depression Rating Scale scores is used to assess the level of depression. The Hamilton Depression Rating Scale ranges from 0 to 50. A score of 0-7 is considered to be normal. A score of 8-13 indicates mild depression. A score of 14-18 indicates moderate depression. Scores higher than 19 indicate severe depression.|8-week||||units on a scale||Standard Deviation|Mean
2598217|NCT02189863|Secondary|Standard Deviation of Lateral Positioning|The standard deviation of lateral positioning (staying in the lane) was assessed during simulated night time driving and measured as the distance of deviation from the reference point, in meters. This outcome measure is prespecified for AOAMV and AOAMF.|Week 2, each period|This analysis population includes all randomized subjects in the groups to which they were randomly assigned who successfully completed both study lens follow-up evaluations without a protocol deviation that was documented as impacting the assessment of the hypotheses (Per-Protocol).|||meters||Standard Deviation|Mean
2598218|NCT02189863|Primary|Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds)|Driving reaction time to hazards was assessed during simulated night time driving and measured as time to brake, in seconds. One eye (study eye) contributed to the analysis. This outcome measure was prespecified for AOAMV and AOAMF.|Week 2, each period|This analysis population includes all randomized subjects in the groups to which they were randomly assigned who successfully completed both study lens follow-up evaluations without a protocol deviation that was documented as impacting the assessment of the hypotheses (Per-Protocol).|||seconds||Standard Deviation|Mean
2598219|NCT02189837|Secondary|Percent Change From Baseline in Lipoprotein(a) Production Rate (PR)|The production rate of lipoprotein(a) was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. Lp(a) was isolated from plasma using an immunoprecipitation method employing immunomagnetic beads and polyacrylamide gel electrophoresis. Isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate protein catabolism.|Baseline and Day 50|Efficacy Analysis Set with available data|||percent change||Standard Error|Least Squares Mean
2598220|NCT02189837|Secondary|Percent Change From Baseline in Lipoprotein (a) Fractional Catabolic Rate (FCR)|The fractional catabolic rate (the percentage of lipoprotein(a) (Lp[a]) which is replaced, transferred or lost per unit of time) was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. Lp(a) was isolated from plasma using an immunoprecipitation method employing immunomagnetic beads and polyacrylamide gel electrophoresis. Isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate protein catabolism.|Baseline (5 days prior to Day 1) and Day 50; plasma samples for fasting lipids were obtained at 0, 5, 10, 20, 30, 40, and 60 min, as well as at 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours, and 2, 3, 4 and 5 days after D3-leucine administration.|Efficacy Analysis Set with available data|||percent change||Standard Error|Least Squares Mean
2598221|NCT02189837|Secondary|Percent Change From Baseline in LDL Apolipoprotein B-100 Production Rate (PR)|The production rate of apolipoprotein B-100 in LDL was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. LDL particles were isolated from plasma by sequential ultracentrifugation and isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate the production rate.|Baseline and Day 50|Efficacy Analysis Set|||percent change||Standard Error|Least Squares Mean
2598222|NCT02189837|Secondary|Percent Change From Baseline in LDL-C at Day 50|LDL-C was measured using ultrcentrifugation.|Baseline and Day 50|Efficacy Analysis Set with available data at both time points|||percent change||Standard Error|Least Squares Mean
2598223|NCT02189837|Primary|Percent Change From Baseline in Low-density Lipoprotein (LDL) Apolipoprotein B-100 Fractional Catabolic Rate (FCR)|The fractional catabolic rate (the percentage of apolipoprotein B-100 in LDL which is replaced, transferred or lost per unit of time) was measured at Baseline and Day 50 over 5 consecutive days using the stable isotope tracer, D3-leucine. LDL particles were isolated from plasma by sequential ultracentrifugation, and isotopic enrichment was determined using gas chromatography-mass spectrometry. Mathematical modelling of the protein enrichment data was used to estimate protein catabolism.|Baseline (5 days prior to Day 1) and Day 50; plasma samples for fasting lipids were obtained at 0, 5, 10, 20, 30, 40, and 60 min, as well as at 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours, and 2, 3, 4 and 5 days after D3-leucine administration.|Efficacy Analysis Set including all randomized and dosed participants who completed baseline and Day 50 measurements.|||percent change||Standard Error|Least Squares Mean
2598224|NCT02189759|Secondary|Duration of Kangaroo Mother Care|Skin to skin contact between baby and mother|Duration of hospitalization-an average of 2 weeks|"Infants in Standard Kanagroo Mother Care to one hour after birth and Standard Kangaroo Mother care to discharge groups received kangaroo mother care only during breastfeeding"|||Hours||Standard Error|Mean
2598225|NCT02189759|Secondary|Number Infants Admitted to the Neonatal Intensive Care Unit|Any admission to the neonatal intensive care unit for higher level care|Duration of hospitalization-an average of 2 weeks||||Participants|||Count of Participants
2598226|NCT02189759|Primary|Number of Infants With Axillary Temperature < 36.0 Degrees Celsius at Discharge|Temperature taken per axilla using diigital thermometer at Discharge or 24hrs after birth|At discharge or 24 hours after birth (whichever is first)||||Participants|||Count of Participants
2598227|NCT02189759|Primary|Number of Infants With Axillary Temperature <36.0 Degrees Celsius|Temperature taken per axilla using digital thermometer|Time of birth to 1 hour||||Participants|||Count of Participants
2598228|NCT02189668|Secondary|Number of Participants With Complicated Appendicitis|Percent of patients found to have complicated appendicitis (gangrenous or perforated) on pathologic examination.|1 year||||Participants|||Count of Participants
2598229|NCT02189668|Primary|Number of Participants That Did Not Have an Appendectomy|Percentage of patients who were successfully managed nonoperatively with success defined as not undergoing appendectomy by one year after discharge|1 year||||Participants|||Count of Participants
2598230|NCT02189629|Secondary|Physician Global Assessment (PGA) Success Rate up to Week 52|Number of subjects who achieved a Physician Global Assessment (PGA) score of 1 (almost clear) or 0 (clear).|From Baseline to Week 52|A total of 455 subjects were enrolled in the study, of whom 453 were treated with CD5789 50 microgram/gram|||Participants|||Count of Participants
2598231|NCT02189629|Primary|Investigator Global Assessment (IGA) Success Rate up to Week 52|Number of subjects who achieved an Investigator Global Assessment (IGA) score of 1 (almost clear) or 0 (clear).|From Baseline to Week 52|A total of 455 subjects were enrolled in the study, of whom 453 were treated with CD5789 50 microgram/gram.|||Participants|||Count of Participants
2598232|NCT02189473|Secondary|Number of Participants Experiencing at Least One Grade >=2 Radiotherapy-related Toxicity|Toxicity was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) (version 4)|during radiotherapy and up to 6 months following radiotherapy||||Participants|||Count of Participants
2598233|NCT02189473|Secondary|Number of Participants Showing Improvement of Motor Deficits at 1 Month Following Radiotherapy|"Motor function was graded with the following 8-point scale: 0, complete paraplegia; 1, palpable or visible muscle contractions; 2, active movement of the leg without gravity; 3, active movement against gravity; 4, active movement against mild resistance; 5, active movement against intermediate resistance; 6, active movement against strong resistance; and 7, normal strength.~Motor function was recorded separately for each leg resulting in total points of 0 to 14. Improvement of motor function was defined as an increase by at least 2 points compared to baseline."|at 1 month following radiotherapy||||Participants|||Count of Participants
2598234|NCT02189473|Secondary|Number of Participants Who Were Alive at 6 Months Following Radiotherapy|"Overall Survival (OS) was defined as freedom from death of any cause.~Time to death was calculated from the last day of radiotherapy, and the patients were followed for a maximum of 6 months after the end of radiotherapy. The values of 6-month OS were estimated using the Kaplan-Meier method."|6 months following radiotherapy||||Percentage of participants|||Number
2598235|NCT02189473|Secondary|Number of Participants Who Experienced Relief of Pain at 1 Month Following Radiotherapy Compared to Baseline|"Pain was measured with a numeric self-rating scale ranging from 0 (no pain) to 10 (worst pain).~Relief of pain was defined as improvement (=decrease of pain) by at least 2 points without increase of analgesics. Patients with baseline-scores of 0-1 points were not included, since improvement by 2 points was not possible."|at 1 month following radiotherapy||||Participants|||Count of Participants
2598236|NCT02189473|Secondary|Number of Participants Who Experienced Relief of Distress at 1 Month Following Radiotherapy Compared to Baseline|"Distress (as an indicator of impairment of quality of life) was measured with the distress-thermometer. the patients rated their level of distress on a scale ranging from 0 (no distress) to 10 (extreme distress). Patients rated the distress they experienced during the last week and stated the reasons for distress from a list of items.~An improvement (lower score) by 2 points was considered a clinically relevant relief of distress. Patients with baseline-scores of 0-1 points were not included, since improvement by 2 points was not possible."|at 1 month following radiotherapy||||Participants|||Count of Participants
2598237|NCT02189473|Secondary|Number of Participants Who Were Alive at 6 Months Following Radiotherapy Without Deterioration of Motor Function During (or Directly Following) Radiotherapy and Freedom From In-field Recurrence of Metastatic Spinal Cord Compression Following Radiotherapy|"Local Progression Free Survival (LPFS) was defined as freedom from progression of motor deficits during or one month following radiotherapy and freedom from in-field recurrence of metastatic spinal cord compression (MSCC) following radiotherapy.~An in-field recurrence was defined as a recurrence of MSCC associated with motor deficits in the region of the spinal cord that had been previously irradiated for MSCC.~In case of clinical suspicion of sich a recurrence, a spinal MRI was performed to confirm the diagnosis. Time to in-field recurrence was calculated from the last day of radiotherapy, and the patients were followed for a maximum of 6 months after the end of radiotherapy. The values of 6-month LPFS were estimated using the Kaplan-Meier method."|6 months following radiotherapy||||Percentage of participants|||Number
2598238|NCT02189473|Secondary|Number of Participants Who Were Able to Walk at 1 Month Following Radiotherapy|"Ambulatory status was assessed using the following scoring system:~0 = Normal strength~= Ambulatory without aid~= Ambulatory with aid~= Not ambulatory~A patient with a score equal to or less than 2 is considered able to walk. Both participants that could and could not walk prior to radiotherapy have been included in this assessment.."|at 1 month following radiotherapy||||Participants|||Count of Participants
2598239|NCT02189473|Primary|Number of Participants Showing Improvement or no Further Progression of Motor Deficits at 1 Month Following Radiotherapy|"Overall response was defined as improvement or no further progression of motor deficits following radiotherapy.~Motor function was graded with the following 8-point scale: 0, complete paraplegia; 1, palpable or visible muscle contractions; 2, active movement of the leg without gravity; 3, active movement against gravity; 4, active movement against mild resistance; 5, active movement against intermediate resistance; 6, active movement against strong resistance; and 7, normal strength.~Motor function was recorded separately for each leg resulting in total points of 0 to 14. Improvement of motor function was defined as an increase by at least 2 points compared to baseline. No further progression was defined as +/-1 point (i.e. +1 point, +/- 0 points or -1 point)."|at 1 month following radiotherapy||||Participants|||Count of Participants
2598240|NCT02189382|Secondary|Change From Baseline in Tactile Threshold|"Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a yes response was repeated. If a second yes was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive yes responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure."|30 days||||Grams (g)||Standard Deviation|Mean
2598241|NCT02189382|Primary|Change From Baseline Air Challenge|The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.|30 days||||units on a scale||Standard Deviation|Mean
2598242|NCT02189317|Secondary|Difference in Time to First Opioid Use|The time difference in hours to first Percocet (7.5/325 tablets) usage post-surgery.|Day of Surgery, Post-Operative Day 6 (Up to 144 hours)|"Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group).~Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group)."|||hours||Standard Deviation|Mean
2598243|NCT02189317|Secondary|Change in Home Opioid Use|The difference in amount of Percocet (7.5/325 tablets) usage post-surgery.|Day of Surgery, Post-Operative Day 6 (Up to 144 hours)|"Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group).~Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group)."|||miligrams||Standard Deviation|Mean
2598244|NCT02189317|Primary|Change in Numerical Rating Scale (NRS) Pain Score|"The numerical rating scale (NRS) pain score is a self-reported pain scale from 0 to 10 where zero is equal to no pain and ten is equal to worst possible pain. The score was recorded every 12 hours for up to 144 hours (six days) post-operatively."|Day of Surgery, Post-Operative Day 6 (Up to 144 hours)|"Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group).~Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group)."|||units on a scale||Standard Deviation|Mean
2598245|NCT02189252|Secondary|Baseline-adjusted Cmax for Plasma Total DPA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2598246|NCT02189252|Secondary|Baseline-adjusted AUC0-24 for Plasma Total DPA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population|||hr*ug/mL||Geometric Coefficient of Variation|Geometric Mean
2598248|NCT02189252|Secondary|Baseline-adjusted AUC0-24 for Plasma Total DHA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population|||hr*ug/mL||Geometric Coefficient of Variation|Geometric Mean
2598249|NCT02189252|Secondary|Baseline-adjusted Cmax for Plasma Total EPA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2598250|NCT02189252|Secondary|Baseline-adjusted AUC0-24 for Plasma Total EPA||participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK Population|||hr*ug/mL||Geometric Coefficient of Variation|Geometric Mean
2598251|NCT02189252|Primary|Baseline-adjusted Cmax for Plasma Total EPA + Total DHA|Cmax: Maximum measured plasma concentration over the time span specified|participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK population|||nmol/mL||Geometric Coefficient of Variation|Geometric Mean
2598252|NCT02189252|Primary|Baseline-adjusted AUC0-24 for Plasma Total EPA + Total DHA|AUC0-24: Area under the plasma concentration versus time curve, from time 0 to 24 hours after start of the meal|participants were followed for the duration of study, up to 12 weeks, each treatment having a 4-week duration and a 4-week wash off period in between.|PK population|||hr*nmol/mL||Geometric Coefficient of Variation|Geometric Mean
2598253|NCT02189161|Secondary|Quality of Life Assessment: Subject Score for Worry About Anal Canal Condition|Median from subject scores for worry about anal canal condition at 0-2 weeks prior to RFA treatment and after 9-12 months post RFA. Median scale range: 0-10 (minimum concern=0, maximum concern=10)|0-2 weeks Prior RFA and after 9-12 months post RFA||||units on a scale||Full Range|Median
2598254|NCT02189161|Secondary|Subject Tolerability: Post -Ablation Anal Pain|Median post-ablation anal pain from 10 patients' survey after RFA treatment. Anal pain scale range: 0-10 (minimum pain=0, maximum pain=10)|within 4 weeks post RFA||||units on a scale||Full Range|Median
2598255|NCT02189161|Primary|Related Adverse Events|Adverse event : Device relationship - Definite, Probable, Possible|Within 12 months post RFA||||number of participants|||Number
2598256|NCT02189122|Primary|Urine Prostacyclin Concentrations at 162.5 mg ASA or NHP-544C Dose||24 hour collection|Data are given for 162.5 mg study day|||ng/mg creatinine||Inter-Quartile Range|Median
2598257|NCT02189122|Primary|Urine Prostacyclin Concentrations at 81 mg ASA or NHP-544C Dose||24 hour collection||||ng/mg creatinine||Inter-Quartile Range|Median
2598258|NCT02189122|Primary|Urine Prostacyclin Concentrations at Placebo ASA or Placebo NHP-544C Dose||24 hour collection||||ng/mg creatinine||Inter-Quartile Range|Median
2598259|NCT02189122|Primary|Urine Thromboxane Concentrations at 162.5 mg ASA or NHP-544C Dose||24 hour collection||||ng/mg creatinine||Inter-Quartile Range|Median
2598260|NCT02189122|Primary|Urine Thromboxane Concentrations at 81mg ASA or NHP-544C Dose||24 hour collection||||ng/mg creatinine||Inter-Quartile Range|Median
2598261|NCT02189122|Primary|Urine Thromboxane Concentrations at Placebo ASA or Placebo NHP-544C Dose||24 hour collection||||ng/mg creatinine||Inter-Quartile Range|Median
2598262|NCT02188849|Other Pre-specified|Serum Creatinine|Serum creatinine levels|Twelve weeks||||mg/dl||Standard Deviation|Mean
2598263|NCT02188849|Secondary|Twelve Minutes Walk|Measurement of the distance that a participant can walk during 12 minutes|Twelve weeks||||meters||Standard Deviation|Mean
2598264|NCT02188849|Secondary|Quadriceps Isometric Strength|Measurement of quadriceps isometric force using a quadriceps table|Twelve weeks||||Newtons||Standard Deviation|Mean
2598265|NCT02188849|Primary|Rectus Femoris Cross Sectional Height|Measurement of rectus femoris cross sectional height in the mid thigh by ultrasound|Twelve weeks||||cm||Standard Deviation|Mean
2598266|NCT02188784|Secondary|Change From Baseline in Ventilatory Efficiency Defined by Ve/VCO2|Change from baseline in Ventilatory Efficiency defined by Ve/VCO2 (carbon dioxide output) as measured by CPET|Measured at BL week 16|All randomized patients with available change data|||VE/VCO2 Slope||Standard Deviation|Mean
2598267|NCT02188784|Secondary|Change From Baseline in O2 Uptake Kinetics as Assessed by Mean Response Time From CPET|To determine the impact of oral Fe repletion on O2 Uptake Kinetics as measured by CPET|Measured at BL week 16|All randomized patients with available change data|||seconds||Standard Deviation|Mean
2598268|NCT02188784|Secondary|Change in Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) - Clinical Summary Score|"To determine the impact of oral Fe repletion on Health Status: KCCQ.~KCCQ is a 23-item, self administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life for patients with congestive heart failure. It is a predictive tool that tracks how patients are doing if they have weakened heart muscle due to prior heart attacks, heart valve problems, viral infections, or other causes.~The KCCQs questions are used to calculate scores in ten domains. Physical Limitation, Symptom Stability, Frequency, Burden and Total Symptom. Social Limitation, Self-Efficacy, Quality of Life, and Clinical Summary. Overall summary: a combined measure of all the above.~For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status."|Measured at Baseline, Week 8 and Week 16|All randomized patients with available change data|||units on a scale||Standard Deviation|Mean
2598269|NCT02188784|Secondary|Change in Plasma NT-pro BNP|To determine the impact of oral Fe repletion on Plasma N-terminal pro-B-type natriuretic peptide (NT-pro BNP)|Measured at Baseline and Week 16|All randomized patients with available change data|||pg/ml||Standard Deviation|Mean
2598270|NCT02188784|Secondary|Change From Baseline in Sub-maximal Exercise Capacity as Assessed by the 6 Minute Walk Test (6MWT)|To determine the impact of oral Fe repletion on Submaximal exercise capacity as measured by 6MWT|Measured at BL, week 8 and week 16|All randomized patients with available change data|||meters||Standard Deviation|Mean
2598271|NCT02188784|Primary|Change in Peak VO2 (ml/Min) (VO2 =Oxygen Consumption)|To determine if oral Fe (Iron) polysaccharide is superior to oral placebo in improving functional capacity as measured by change in peak VO2 by CPET (Cardiopulmonary Exercise Testing) , of a broad population of patients with HFrEF (Heart Failure with Reduced Ejection Fraction) and Fe deficiency at 16 weeks.|Baseline (BL) and Week 16|All randomized patients with available change data|||mL/min||Standard Deviation|Mean
2598272|NCT02188589|Secondary|NOSE Responder Rate|Percent of participants meeting responder criteria. Responders are defined as participants with a reduction from baseline in 1 or more Nasal Obstruction Symptom Evaluation Score (NOSE) severity class or a 20% reduction in the NOSE score.|At 6, 12, and 24 months post implant|All 30 participants completed follow-up through 12 months. Five participants discontinued after the 12-month visit and before the 24-month visit.|||percentage of responders|||Number
2598273|NCT02188589|Secondary|Breathing Capacity (NOSE Scores)|Nasal breathing capacity was assessed using the validated Nasal Obstruction Symptom Evaluation (NOSE) questionnaire. The NOSE score uses a 0-100 point scale to capture severity of nasal symptoms (congestion, obstruction, trouble breathing, sleeping, and exercise), with higher scores indicating more severe symptoms than lower scores. NOSE severity classes are defined as Mild (5-25), Moderate (30-50), Severe (55-75), and Extreme (80-100).|At baseline and at 6, 12, and 24 months post implant|All 30 participants completed follow-up through 12 months. Five participants discontinued after the 12-month visit and before the 24-month visit.|||scores on a scale||Standard Deviation|Mean
2598274|NCT02188589|Primary|Implant-related Adverse Events|Implant-related adverse events (such as implant retrievals, procedure-related hematoma/inflammation)|6 months||||participants|||Number
2598275|NCT02188576|Secondary|Plasma Levels of TXA in Children Having Craniosynostosis Surgery|Determine the plasma levels (in micrograms/mL) of TXA in infants and children undergoing open craniofacial surgery with this dosage scheme|up to 24h postoperatively||||ug/mL||Standard Error|Mean
2598276|NCT02188576|Primary|Efficacy of TXA in Childrens Having Craniosynostosis Surgery|Determine the efficacy ( as measured by blood loss and blood transfusion) of TXA in infants and children undergoing open craniofacial surgery with this lower dosage scheme.|perioperatively from the intraoperative period to 24 hours postoperatively|To determine if a tranexamic acid dose regimen of 10 mg/kg loading dose and 5 mg/kg/h maintenance dose is as effective as a higher dose regime of 50 mg/kg loading dose and 5 mg/kg/h maintenance infusion rate in reducing blood transfusion volume in pediatric craniosynostosis reconstruction surgery.|||mL/kg||Standard Error|Mean
2598277|NCT02187887|Primary|Alcohol-related Consequences|"Brief Young Adult Alcohol Consequences Questionnaire. This is a 21 item measure of alcohol-related consequences experienced by young adults. Participants indicate whether or not they have experienced each of the consequences in the past month (1 = yes, 0 = no). Scores range from 0 to 21 with higher scores indicated a greater number of consequences experienced.~Citation: Kahler, C. W., Strong, D. R., & Read, J. P. (2005). Toward efficient and comprehensive measurement of the alcohol problems continuum in college students: The Brief Young Adult Alcohol Consequences Questionnaire. Alcoholism: Clinical and Experimental Research, 29(7), 1180-1189."|Past month (30 days)||||consequences at follow-up month||Standard Deviation|Mean
2598278|NCT02187887|Primary|Alcohol Use|Total drinks per week in the past 30 days|Past month (30 days)||||drinks per week at follow-up month||Standard Deviation|Mean
2598279|NCT02187861|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to 8 Hours Post Dose (AUC0-8h) of Venetoclax|Area under the plasma concentration versus time curve from time 0 (pre-dose) to 8 hours post dose (AUC0-8h).|Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)|Pharmacokinetic-evaluable population. ‘Overall number of participants analyzed’=those evaluable for this outcome measure.|||hours*ng/mL||Standard Deviation|Mean
2598280|NCT02187861|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Concentration (AUClast) of Venetoclax|Area under the plasma concentration versus time curve from zero to the last measured concentration (AUClast).|Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)|Pharmacokinetic-evaluable population|||hours*ng/mL||Standard Deviation|Mean
2598281|NCT02187861|Secondary|Maximum Plasma Concentration (Cmax) of Venetoclax||Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)|Pharmacokinetic-evaluable population|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2598282|NCT02187861|Secondary|Time to Maximum Plasma Concentration (Tmax) of Venetoclax||Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)|Pharmacokinetic-evaluable population included all enrolled participants with available pharmacokinetic data for venetoclax.|||hours||Full Range|Median
2598283|NCT02187861|Secondary|Apparent Volume of Distribution (Vd) of Venetoclax|Vd was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)|The data could not be collected as the timepoints for pharmacokinetics collection and the daily dosing of venetoclax did not permit an assessment of Vd.||||||
2598284|NCT02187861|Secondary|Apparent Clearance (CL) of Venetoclax|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-dose (within 30 minutes), and 2, 4, 6, 8 hours post-dose on Cycle 1 Day 1; pre-dose (within 30 minutes) on Cycle 1 Days 8, 15, 22; pre-dose (within 30 minutes) and 4 hours post-dose on Day 1 of Cycles 4 and 6 (Cycle length = 28 days)|The data could not be collected as the timepoints for pharmacokinetics collection and the daily dosing of venetoclax did not permit an assessment of CL.||||||
2598285|NCT02187861|Secondary|Overall Survival (OS)|OS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to death due to any cause. For participants who are alive, OS was censored at the last contact. OS was calculated using Kaplan-Meier method.|Baseline until death due to any cause (assessed up to approximately 2.5 years)|ITT population|||months||95% Confidence Interval|Median
2598286|NCT02187861|Secondary|Percentage of Participants Who Died Due to Any Cause||Baseline until death due to any cause (assessed up to approximately 2.5 years|ITT population|||percentage of participants|||Number
2598287|NCT02187861|Secondary|Event-Free Survival (EFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan|EFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) to the date of disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. EFS was calculated using Kaplan-Meier method.|Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years)|ITT population|||months||95% Confidence Interval|Median
2598288|NCT02187861|Secondary|Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan), Death, or Start of a New Anti-lymphoma Therapy|PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.|Baseline until disease progression, death, or start of a new anti-lymphoma therapy whichever occurred first (assessed up to approximately 2.5 years)|ITT population|||percentage of participants|||Number
2598289|NCT02187861|Secondary|Progression-Free Survival (PFS) According to Investigator as Per Lugano Classification, Using PET or CT Scan|PFS was defined as the period from the date of treatment initiation (Safety Run-in and Arm A) or randomization date (Arms B and C) until the date of disease progression, or death due to any cause. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan. PFS was calculated using Kaplan-Meier method.|Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)|ITT population|||months||95% Confidence Interval|Median
2598290|NCT02187861|Secondary|Percentage of Participants With Disease Progression (According to Investigator as Per Lugano Classification, Using PET or CT Scan) or Death|PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET or CT scan.|Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)|ITT population|||percentage of participants|||Number
2598291|NCT02187861|Secondary|Duration of Response (DOR) According to Investigator as Per Lugano Classification, Using PET or CT Scan|DOR was defined as time from CMR/CR or PMR/PR until progressive disease (PD) or death due to any cause. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. PD: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with increase in intensity of uptake from baseline on PET 5-PS for individual target nodes/nodal lesions; new FDG-avid foci for extranodal lesions; new FDG-avid foci consistent with lymphoma for new lesions; or new or recurrent FDG-avid foci for bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing). DOR was calculated using Kaplan-Meier method.|From CMR or PMR until disease progression or death due to any cause (assessed up to approximately 2.5 years)|ITT population. ‘Overall number of participants analyzed’=those evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2598292|NCT02187861|Secondary|Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET or CT Scan|OR was defined as CMR/CR or PMR/PR. CMR, CR, PMR, and PR have been defined in previous endpoints, and are not repeated here due to space constraint. Assessment was performed by Investigator according to Lugano classification using PET scan or CT scan (if PET is missing).|Baseline until disease progression or death due to any cause (assessed up to approximately 2.5 years)|ITT population. ‘Overall number of participants analyzed’=those evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2598293|NCT02187861|Secondary|Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using CT Scan|OR was defined as CR or PR. CR: reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: >=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least >50% beyond normal; and no new lesions. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
2598294|NCT02187861|Secondary|Percentage of Participants With OR According to IRC as Per Lugano Classification, Using CT Scan|OR was defined as CR or Partial Response (PR). CR: reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. PR: greater than or equal to (>=) 50 percent (%) decrease in sum of the product of the perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen at least >50% beyond normal; and no new lesions. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
2599933|NCT02169219|Secondary|Sustained Complete Remission|Number of patients entering sustained remission defined as BVAS/WG = 0, prednisone dose = 0 and no disease flares during the study period.|6 months||||Participants|||Count of Participants
2598295|NCT02187861|Secondary|Percentage of Participants With OR According to Investigator as Per Lugano Classification, Using PET Scan|OR was defined as CMR or PMR. CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
2598296|NCT02187861|Secondary|Percentage of Participants With Objective Response (OR) According to IRC as Per Lugano Classification, Using PET Scan|OR was defined as CMR or Partial Metabolic Response (PMR). CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PMR: a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
2598297|NCT02187861|Secondary|Percentage of Participants With CR According to Investigator as Per Lugano Classification, Using CT Scan|CR: defined as reduction of LDi of target nodes/nodal masses to <=1.5 cm, and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/IHC-negative bone marrow morphology. Assessment was performed by Investigator according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|4-10 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
2598298|NCT02187861|Secondary|Percentage of Participants With Complete Response (CR) According to IRC as Per Lugano Classification, Using Computed Tomography (CT) Scan|CR: defined as reduction of longest transverse diameter of lesion (LDi) of target nodes/nodal masses to <=1.5 centimeters (cm), and no extralymphatic sites of disease; absence of non-measured lesions and new lesions; reduction of enlarged organs to normal; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. Assessment was performed by an IRC according to Lugano classification using CT scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 6 Day 1 and 48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
2598299|NCT02187861|Secondary|Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at Year 1|CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
2598300|NCT02187861|Secondary|Percentage of Participants With CMR According to IRC as Per Lugano Classification, Using PET Scan at Year 1|CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (uptake <mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|48-56 weeks after Cycle 1 Day 1 (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
2598301|NCT02187861|Secondary|Percentage of Participants With CMR According to Investigator as Per Lugano Classification, Using PET Scan at PRA|CMR: a score 1 (no uptake above background), 2 (uptake <=mediastinum), or 3 (<mediastinum but <=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. Assessment was performed by Investigator according to Lugano classification using PET scan. 95% CI for percentage of responders was calculated using Clopper-Pearson method.|4-10 weeks after Cycle 6 Day 1 (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
2598302|NCT02187861|Primary|Percentage of Participants With Complete Metabolic Response (CMR) According to Independent Review Committee (IRC) as Per Lugano Classification, Using Positron Emission Tomography (PET) Scan at Primary Response Assessment (PRA)|CMR: a score 1 (no uptake above background), 2 (uptake less than or equal to [<=] mediastinum), or 3 (uptake less than [<] mediastinum but <=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites with no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Assessment was performed by an IRC according to Lugano classification using PET scan. 95% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 6 Day 1 (PRA) (Cycle length = 28 days)|ITT population|||percentage of participants||95% Confidence Interval|Number
2598303|NCT02187809|Secondary|Percentage of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)||Baseline and from Day 0 to Day 360|At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.||||||
2598304|NCT02187809|Secondary|Number of Initial Treatment Responders Who Returned to Their Baseline Tonic-clonic and Clonic Seizure Rate During the Study (an Assessment of Tachyphylaxis)||Baseline and from Day 0 to Day 360|At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.||||||
2609774|NCT02062177|Secondary|Number of Participants With Adverse Events as a Measure of Safety|Number of patients with adverse events (hypotension, bradycardia, hypoxemia,...)|one day|||||||
2598305|NCT02187809|Secondary|Change in Mean Weekly Number of Tonic-clonic and Clonic Seizures||Baseline and from Day 0 to Day 360 and upon Study Completion/Withdrawal|At the time of study termination, only one patient had received IMP. No seizure data were summarised for that single patient.||||||
2598306|NCT02187809|Primary|Change in Behavioural, Neurocognitive Measures Using Vineland Adaptive Behaviour Scale (VABS)||Baseline and from Day 0 to Day 360|At the time of study termination, only one patient had received IMP. No VABS data were recorded for that single patient.||||||
2598307|NCT02187809|Primary|Columbia Suicide Severity Rating Scale (C-SSRS), Categorisation Based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories (1, 2, 3, 4 and 7) for Patients Aged ≥ 6 Years||Baseline and from Day 0 to Day 360|At the time of study termination, one patient had received IMP. No C-SSRS data were collected from that single patient.||||||
2598308|NCT02187809|Primary|Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose||Up to Day 390|At the time of study termination, only one patient had received IMP. No adverse events were observed in the study|||participants|||Number
2598309|NCT02187809|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||Up to Day 390|At the time of study termination, only one patient had received IMP. No adverse events were observed in the study.|||participants|||Number
2598310|NCT02187783|Primary|Overall Response Rate (ORR) ≥ 16 Weeks. FAS|ORR was determined by local, Investigator assessment for each tumor assessment and defined as responses of CR+PR ≥ 16 weeks. FAS|Baseline and ≥ 16 weeks up to approximately 36 months||||participant||95% Confidence Interval|Number
2598311|NCT02187783|Secondary|Number of Days for Duration of Response for Responders|Duration of response (DOR) is defined as time from the first documented response to the date first documented disease progression or relapse or death due to any cause. For patients with solid tumors the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR.|Baseline up to approximately 36 months||||Days|||Number
2598312|NCT02187783|Secondary|Overall Survival (OS)|Number of participants Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause.|Baseline up to approximately 36 months||||months||95% Confidence Interval|Median
2598313|NCT02187783|Secondary|Progression Free Survival (PFS)|Progression-free survival (PFS) is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause within 30 days of the last dose. If a subject has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Progressive disease is defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progression)|Every 8 weeks until death, assessed up to 24 months||||months||95% Confidence Interval|Median
2598314|NCT02187783|Primary|Clinical Benefit Rate (CBR) of ≥ 16 Weeks FAS|CBR was determined by local, Investigator assessment for each tumor assessment and defined as responses of CR + PR + SD for ≥ 16 weeks. CR and PR (for solid tumors) required a confirmation at least 4 weeks after the initial response observation. For hematologic tumors other appropriate hematological response criteria was applied. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 mm, PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study, PD=At least a 20% increase in the sum of diameter of all measured target lesions and also demonstrate an absolute increase of at least 5 mm FAS|Baseline and ≥ 16 weeks up to approximately 36 months||||participant||95% Confidence Interval|Number
2598315|NCT02187783|Primary|Number of Participants With Solid Tumor Response ≥ 16 Weeks for Based Upon Local Investigator Assessments|Clinical benefit (CB) for patients with solid tumors were assessed using RECIST 1.1 and included responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for ≥ 16 weeks. CR and PR (for solid tumors) required a confirmation at least 4 weeks after the initial response observation. For hematologic tumors other appropriate hematological response criteria was applied. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 mm, PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study, PD=At least a 20% increase in the sum of diameter of all measured target lesions and also demonstrate an absolute increase of at least 5 mm. FAS|Baseline up ≥16 weeks up to approximately 36 months||||Participants|||Count of Participants
2598316|NCT02187744|Secondary|Incidence of Neutralizing Antibodies (NAb) at Cycles 1 Through 6.|The number of participants with positive (NAb response >=1.48) pre-dose NAb samples, participants counted towards the total if for at least one sample, the NAb was positive.|Cycles 1 through 6|All participants who received at least 1 dose of study drug.|||Number of participants|||Number
2598317|NCT02187744|Secondary|Incidence of Anti-trastuzumab Antibodies (ADAs) at Cycles 1 Through 6.|The number of participants with positive (titer >=1.00) pre-dose ADA samples, participants counted towards the total if for at least one sample, the ADA was positive.|Cycles 1 through 6|All participants who received at least 1 dose of study drug.|||Number of participants|||Number
2598318|NCT02187744|Secondary|Objective Response Rate (ORR) Defined as the Percentage of Participants Having Complete or Partial Response at End of Treatment, Based on Radiographic Assessments of the Tumor.|ORR was defined as Complete Response (CR), Partial Response (PR), Stable (SD), Progressive Disease (PD) or Indeterminate (IND). ORR was the percentage of participants who had CR or PR at Cycle 6/End of treatment.|Cycle 6/End of treatment|All participants who were HER2+ and randomized into the study; and who have received 6 cycles of PF-05280014 or trastuzumab-EU treatment; and had no temporary delays of PF-05280014 or trastuzumab-EU treatment lasting more than 1 week; and had no other significant protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
2598524|NCT02185339|Secondary|Arterial Oxygen Tension/Inspired Oxygen Fraction|Was calculated from arterial blood oxygen analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.|intraoperative||||mmHg||Standard Deviation|Mean
2598319|NCT02187744|Secondary|Pathologic Complete Response (pCR) Defined as the Absence of Invasive Neoplastic Cells in the Breast and Lymph Nodes.|Following surgery after treatment completion, tumors were assessed as Complete Pathological Response, Partial Pathological Response, or No Pathological Response.|Cycle 6/End of treatment|All participants who were HER2+ and randomized into the study; and who have received 6 cycles of PF-05280014 or trastuzumab-EU treatment; and had no temporary delays of PF-05280014 or trastuzumab-EU treatment lasting more than 1 week; and had no other significant protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
2598320|NCT02187744|Secondary|Mean Predose Trastuzumab-Pfizer and Trastuzumab-EU Concentrations at Cycles 1 Through 6.|Samples of blood were taken pre-dose on Cycles 1, 2, 4, 5, and 6, and at 1 hour post dose on Cycles 1 and 5 for pharmacokinetic evaluation.|Cycles 1 through 6|All participants who were HER2+ and randomized into the study; and who have received 6 cycles of PF-05280014 or trastuzumab-EU treatment; and had no temporary delays of PF-05280014 or trastuzumab-EU treatment lasting more than 1 week; and had no other significant protocol deviations.|||μg/mL||Standard Deviation|Mean
2598321|NCT02187744|Primary|Percentage of Participants With Steady State Drug Concentration Ctrough (Cycle 6 Pre-dose) >20 µg/mL at Cycle 5.|The percentage of participants with Cycle 5 Ctrough (Cycle 6 pre-dose) >20 μg/mL in each treatment group, the denominator being the number of participants in the per protocol population for each treatment group.|Cycle 5|All participants who were HER2+ and randomized into the study; and who had received 6 cycles of PF-05280014 or trastuzumab-EU treatment; and had no temporary delays of PF-05280014 or trastuzumab-EU treatment lasting more than 1 week; and had no other significant protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
2598322|NCT02187172|Secondary|Change in Patient-reported Physical Activity Assessments: IPAQ|"To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IPAQ, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).~IPAQ is an instrument designed primarily for population surveillance of physical activity among adults with activity measured in metabolic equivalent (MET)-minutes per week."|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)||||MET-minutes/week||Standard Error|Mean
2598323|NCT02187172|Secondary|Change in Patient-Reported Outcomes: MEDFICTS|"To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on MEDFICTS, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).~MEDFICTS (Meats, Eggs, Dairy, Fried foods, fat In baked goods, Convenience foods, fats added at the Table, and Snacks), a brief dietary assessment instrument, has been provided as part of the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) guidelines as a free tool to use for proper cardiovascular diet assessment. The questionnaire yields a continuous score (ranging from 0 to 216), with a score of <40 indicating adherence to the Therapeutic Lifestyle Changes (TLC) diet (intake of <7% of energy from saturated fat, <30% of energy from total fat, and <200 mg dietary cholesterol/day)."|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)||||MEDFICTS score||Standard Error|Mean
2598324|NCT02187172|Secondary|Number of Participants Achieving Physician Global Assessment (PGA) Clear/Almost Clear|"To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PGA clear/almost clear, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).~Binary measure of psoriasis disease activity at measurement time points; Physician Global Assessment score <1.5 (clear/almost clear)"|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)||||Participants|||Count of Participants
2598325|NCT02187172|Secondary|Number of Participants Achieving PASI90 (90% or Greater Reduction in PASI Score)|"To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PASI90, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).~Binary measure of change in psoriasis activity; 90% or greater reduction in PASI score compared to baseline."|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)||||Participants|||Count of Participants
2598326|NCT02187172|Secondary|Number of Participants Achieving PASI75 (75% or Greater Reduction in PASI Score)|"To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PASI75, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).~Binary measure of change in psoriasis activity; 75% or greater reduction in PASI score compared to baseline."|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)||||Participants|||Count of Participants
2598327|NCT02187172|Primary|Change in Metabolic Biomarker Levels: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|"To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HOMA-IR, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).~HOMA-IR, a method used to quantify insulin resistance and beta-cell function, is expressed using fasting blood glucose and insulin levels. It is calculated using the formula (HOMA-IR = fasting glucose [mg/dl] * fasting insulin [mU/ml]/405)."|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||unitless (see description)||Standard Error|Mean
2598328|NCT02187172|Primary|Change in Metabolic Biomarker Levels: Glucose|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Glucose, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||mg/dL||Standard Error|Mean
2598649|NCT02183792|Other Pre-specified|Serum Sodium Change|Difference assessed at baseline, 8, 24, 48, 72 and 96 hours.|Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days|||||||
2598329|NCT02187172|Primary|Change in Metabolic Biomarker Levels: Insulin|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Insulin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||pg/mL||Standard Error|Mean
2598330|NCT02187172|Primary|Change in Metabolic Biomarker Levels: Leptin|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Leptin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||pg/mL||Standard Error|Mean
2598331|NCT02187172|Primary|Change in Metabolic Biomarker Levels: Adiponectin|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Adiponectin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||ug/mL||Standard Error|Mean
2598332|NCT02187172|Primary|Change in Lipid Biomarker Levels: Fetuin-A|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Fetuin-A, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||ug/mL||Standard Error|Mean
2598333|NCT02187172|Primary|Change in Lipid Biomarker Levels: Apolipoprotein-B|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Apolipoprotein-B, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||ug/mL||Standard Error|Mean
2598334|NCT02187172|Primary|Change in Lipid Biomarker Levels: Cholesterol Efflux Capacity|"To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Cholesterol efflux capacity, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).~The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: [(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)]."|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||unitless (see description)||Standard Error|Mean
2598335|NCT02187172|Primary|Change in Lipid Biomarker Levels: Intermediate-density Lipoprotein (IDL) Particle Number|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||nmol/L||Standard Error|Mean
2598336|NCT02187172|Primary|Change in Lipid Biomarker Levels: Large-VLDL Particle Number|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||nmol/L||Standard Error|Mean
2598390|NCT02187055|Secondary|Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6|ACR70 response is a ≥70% improvement in TJC or SJC and 70% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.|Month 6|FAS|||Percentage of participants|||Number
2598337|NCT02187172|Primary|Change in Lipid Biomarker Levels: Large Medium-VLDL Particle Number|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large medium-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||nmol/L||Standard Error|Mean
2598338|NCT02187172|Primary|Change in Lipid Biomarker Levels: Medium-VLDL Particle Number|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Medium-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||nmol/L||Standard Error|Mean
2598339|NCT02187172|Primary|Change in Lipid Biomarker Levels: Small-VLDL Particle Number|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||nmol/L||Standard Error|Mean
2598340|NCT02187172|Primary|Change in Lipid Biomarker Levels: VLDL Triglycerides|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL triglycerides, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||mg/dL||Standard Error|Mean
2598341|NCT02187172|Primary|Change in Lipid Biomarker Levels: VLDL Particle Number|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||nmol/L||Standard Error|Mean
2598342|NCT02187172|Primary|Change in Lipid Biomarker Levels: Very Low-density Lipoprotein (VLDL) Particle Size|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||nmol/L||Standard Error|Mean
2598343|NCT02187172|Primary|Change in Lipid Biomarker Levels: Very Large-LDL Particle Number|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Very large-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||nmol/L||Standard Error|Mean
2598344|NCT02187172|Primary|Change in Lipid Biomarker Levels: Large-LDL Particle Number|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||nmol/L||Standard Error|Mean
2598345|NCT02187172|Primary|Change in Lipid Biomarker Levels: Small-LDL Particle Number|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||nmol/L||Standard Error|Mean
2598394|NCT02187055|Secondary|Percentage of Participants Achieving CDAI ≤10 at Month 6|CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, >2.8 to 10 indicates low disease activity.|Month 6|FAS|||Percentage of participants|||Number
2598346|NCT02187172|Primary|Change in Lipid Biomarker Levels: LDL Particle Size|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||nmol/L||Standard Error|Mean
2598347|NCT02187172|Primary|Change in Lipid Biomarker Levels: LDL Particle Number|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||nmol/L||Standard Error|Mean
2598348|NCT02187172|Primary|Change in Lipid Biomarker Levels: Low-density Lipoprotein (LDL) Cholesterol|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||mg/dL||Standard Error|Mean
2598349|NCT02187172|Primary|Change in Lipid Biomarker Levels: Large Medium-HDL Particle Number|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large medium-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||nmol/L||Standard Error|Mean
2598350|NCT02187172|Primary|Change in Lipid Biomarker Levels: Medium-HDL Particle Number|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Medium-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||nmol/L||Standard Error|Mean
2598351|NCT02187172|Primary|Change in Lipid Biomarker Levels: Small-HDL Particle Number|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||nmol/L||Standard Error|Mean
2598352|NCT02187172|Primary|Change in Lipid Biomarker Levels: Large-HDL Particle Number|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||nmol/L||Standard Error|Mean
2598353|NCT02187172|Primary|Change in Lipid Biomarker Levels: HDL Particle Size|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||nm||Standard Error|Mean
2598354|NCT02187172|Primary|Change in Lipid Biomarker Levels: HDL Particle Number|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||nmol/L||Standard Error|Mean
2598391|NCT02187055|Secondary|Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6|ACR20 response is a ≥20% improvement in TJC or SJC and 20% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.|Month 6|FAS|||Percentage of participants|||Number
2598355|NCT02187172|Primary|Change in Lipid Biomarker Levels: High-density Lipoprotein (HDL) Cholesterol|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||mg/dL||Standard Error|Mean
2598356|NCT02187172|Primary|Change in Lipid Biomarker Levels: Total Cholesterol|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Total cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||mg/dL||Standard Error|Mean
2598357|NCT02187172|Primary|Change in Lipid Biomarker Levels: Triglycerides|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Triglycerides, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||mg/dL||Standard Error|Mean
2598358|NCT02187172|Primary|Change in Inflammatory Biomarker Levels: IL-8|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-8, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||pg/mL||Standard Error|Mean
2598359|NCT02187172|Primary|Change in Inflammatory Biomarker Levels: IL-6|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-6, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||pg/mL||Standard Error|Mean
2598360|NCT02187172|Primary|Change in Inflammatory Biomarker Levels: IL-18|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-18, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||pg/mL||Standard Error|Mean
2598361|NCT02187172|Primary|Change in Inflammatory Biomarker Levels: IL-17a|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-17a, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||pg/mL||Standard Error|Mean
2598362|NCT02187172|Primary|Change in Inflammatory Biomarker Levels: IL-12/23|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-12/23, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||pg/mL||Standard Error|Mean
2598363|NCT02187172|Primary|Change in Inflammatory Biomarker Levels: IL-2ra|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-2ra, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||ng/mL||Standard Error|Mean
2598392|NCT02187055|Secondary|Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6|DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity.|Month 6|FAS|||Percentage of participants|||Number
2598364|NCT02187172|Primary|Change in Inflammatory Biomarker Levels: Interleukin (IL)-1b|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-1b, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||pg/mL||Standard Error|Mean
2598365|NCT02187172|Primary|Change in Inflammatory Biomarker Levels: GlycA|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on GlycA, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||umol/L||Standard Error|Mean
2598366|NCT02187172|Primary|Change in Inflammatory Biomarker Levels: Tumor Necrosis Factor-alpha (TNF-a)|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on TNF-a, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||pg/mL||Standard Error|Mean
2598367|NCT02187172|Primary|Change in Inflammatory Biomarker Levels: Monocyte Chemoattractant Protein-1 (MCP-1)|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on MCP-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||pg/mL||Standard Error|Mean
2598368|NCT02187172|Primary|Change in Inflammatory Biomarker Levels: Interferon-gamma (INF-g)|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on INF-g,, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||pg/mL||Standard Error|Mean
2598369|NCT02187172|Primary|Change in Inflammatory Biomarker Levels: Serum Amyloid A (SAA)|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on SAA, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||ng/mL||Standard Error|Mean
2598370|NCT02187172|Primary|Change in Inflammatory Biomarker Levels: Ferritin|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Ferritin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||ng/mL||Standard Error|Mean
2598371|NCT02187172|Primary|Change in Inflammatory Biomarker Levels: C-reactive Protein (CRP)|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on CRP, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||ng/mL||Standard Error|Mean
2598372|NCT02187172|Primary|Change in Inflammatory Biomarker Levels: Vascular Cell Adhesion Molecule-1 (VCAM-1)|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VCAM-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||ng/mL||Standard Error|Mean
2598393|NCT02187055|Secondary|Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6|DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) ≤3.2 indicates low disease activity.|Month 6|FAS|||Percentage of participants|||Number
2598373|NCT02187172|Primary|Change in Inflammatory Biomarker Levels: Intercellular Adhesion Molecule-1 (ICAM-1)|To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on ICAM-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||ng/mL||Standard Error|Mean
2598374|NCT02187172|Primary|Change in Vascular Inflammation|Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between baseline and week 12 (RCT period) or end of study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period). The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUV mean yielding a target to background ratio (TBR).|Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)|"The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite Total group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2."|||TBR max||Standard Error|Mean
2598375|NCT02187055|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Month 6|FAS|||Units on a scale||Standard Error|Least Squares Mean
2598376|NCT02187055|Secondary|Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6|"The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). This profile of scores across the 5-dimensions (e.g. 11231, 33212, etc.) is transformed into a single health utility score using a formula developed by the EuroQol Group that applies country specific preference weights. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rated the current health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state."|Month 6|FAS|||Units on a scale||Standard Error|Least Squares Mean
2598377|NCT02187055|Secondary|Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6|The WPAI: Rheumatoid Arthritis is a 6 item questionnaire that is specific for rheumatoid arthritis and yields four types of scores: absenteeism, presenteesism (impairment at work/reduced job effectiveness), work productivity loss and activity impairment. WPAI outcomes are expressed as impairment percentages ranging from 0 to 100, with higher numbers indicating greater impairment and less productivity.|Month 6|FAS|||Percentage of impairment||Standard Error|Least Squares Mean
2598378|NCT02187055|Secondary|Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher mental health domain score represents better mental health functioning.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
2598379|NCT02187055|Secondary|Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 3-item role emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role emotional domain score represents better role emotional functioning.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
2598380|NCT02187055|Secondary|Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher social functioning domain score represents better social functioning.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
2598381|NCT02187055|Secondary|Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher vitality domain score represents better vitality.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
2598382|NCT02187055|Secondary|Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher general health domain score represents better general health perceptions.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
2598383|NCT02187055|Secondary|Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher bodily pain domain score represents less bodily pain.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
2598384|NCT02187055|Secondary|Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6|SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item role physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; and d) accomplishing less. Items in the role physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role physical domain score represents better role physical functioning.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
2598385|NCT02187055|Secondary|Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6|SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 10 items of the physical functioning scale represent levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher physical functioning domain score represents better physical functioning.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
2598386|NCT02187055|Secondary|Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6|The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better physical health status.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
2598387|NCT02187055|Secondary|Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6|The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based scores for both the SF-36 version 2 (v2) and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
2598388|NCT02187055|Secondary|Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6|The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. A decrease of 0.22 or more is considered a positive response.|Month 6|FAS|||Percentage of participants|||Number
2598389|NCT02187055|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6|The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.|Month 6|FAS|||Units on a scale||Standard Error|Least Squares Mean
2598395|NCT02187055|Secondary|Percentage of Participants Achieving SDAI ≤11 at Month 6|SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission, >3.4 to 11 indicates low disease activity.|Month 6|FAS|||Percentage of participants|||Number
2598396|NCT02187055|Secondary|Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6|DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (mm) + 0.96. Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (CRP) <2.6 indicates remission.|Month 6|FAS|||Percentage of participants|||Number
2598397|NCT02187055|Secondary|Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6|DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) <2.6 indicates disease remission.|Month 6|FAS|||Percentage of participants|||Number
2598398|NCT02187055|Secondary|Percentage of Participants Achieving CDAI ≤2.8 at Month 6|CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission.|Month 6|FAS|||Percentage of participants|||Number
2598399|NCT02187055|Secondary|Percentage of Participants Achieving SDAI ≤3.3 at Month 6|SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission.|Month 6|FAS|||Percentage of participants|||Number
2598400|NCT02187055|Secondary|Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6|To meet the ACR-EULAR Boolean remission criteria, a participant must satisfy all of the following: TJC ≤1 and SJC ≤1 (both based on a 28-joint assessment), CRP ≤1 mg/dL, and PtGA ≤1 on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity).|Month 6|FAS|||Percentage of participants|||Number
2598401|NCT02187055|Secondary|Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6|DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-3 (ESR) ≤3.2 indicates low disease activity, >3.2 to 5.1 indicates moderate to high disease activity, and <2.6 indicates remission.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
2598402|NCT02187055|Secondary|Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6|DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (millimeters [mm]) + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity, >3.2 to 5.1 indicates moderate to high disease activity, and less than (<) 2.6 indicates remission.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
2598403|NCT02187055|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6|CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
2598404|NCT02187055|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6|SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 centimeter (cm) visual analogue scale (VAS) (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI less than or equal to (≤) 3.3 indicates disease remission, >3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity.|Month 6|FAS|||Score on a scale||Standard Error|Least Squares Mean
2598405|NCT02187055|Primary|Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6|ACR50 is a greater than or equal to (≥) 50 percent (%) improvement in tender joint count (TJC) or swollen joint count (SJC) and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment (PGA) of disease activity, 2) participant's assessment (PtGA) of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein (CRP) at each visit.|Month 6|Full analysis set (FAS) included all participants who were randomized and received at least one dose of the randomized investigational drug (tofacitinib or adalimumab).|||Percentage of participants|||Number
2598406|NCT02187042|Secondary|Number of Telephone Calls Where Participants Declared Adverse Events|In this outcome measure total number of telephone calls where participants declared of any AE are reported. Participants could call more than once to declare AE.|Baseline up to 6 months|"Call center full analysis set (FAS) population included all participants who were investigated by doctors, who met the study eligibility criteria and had received at least 1 dose of Sunitinib and were followed up by call center. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||Telephone calls|Telephone calls||Number
2598439|NCT02187029|Secondary|Incidence and Severity of Gout Flare Attacks||Baseline up to Day 42|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment.|||participants|||Number
2598407|NCT02187042|Secondary|Number of Telephone Calls Describing Actions Taken by Call Center|In this outcome measure number of telephone calls against each action taken/or described by the call center to the participants are reported. Actions taken by the call center included: 1) Given advice about managing the treatment: a) advice about taking Sunitinib, b) advice about using the Sunitinib follow-up diary, c) reporting any AE; 2) Given general preventative advice: a) advice about taking preventative systemic treatments, b) lifestyle advice, c) food/dietetic advice, d) oro-dental hygiene advice; 3) Given specific preventative advice for a type of AE: a) prevention of skin toxicities, b) prevention of gastrointestinal disorders, c) prevention of cardiac disorders, d) prevention of infectious/inflammatory problems, e)other preventative advice; 4) Actions recommended to participant: a) do not forget the planned consultation with the oncologist, b) get the additional investigations requested performed.|Baseline up to 6 months|"Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||Telephone calls|Telephone calls||Number
2598408|NCT02187042|Secondary|"Number of Participants With Their Responses as Yes Against the Actions of Investigating Physicians, as Told to Call Center During the First Call"|"Actions of investigating doctors/physicians: did doctor clearly explained how to take treatment, were participants given documentation about treatment by doctor or medical team, did doctor explained how to manage any side effects due to treatment which could occur and were prescriptions or orders for supportive medical treatments given by doctor. Participants responded either Yes or No. In this outcome measure participants who responded Yes to each action are reported."|First call made anytime from baseline up to 6 months|"Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||Participants|||Count of Participants
2598409|NCT02187042|Secondary|Number of Participants Who Were Taking Sunitinib as Told to Call Center During the First Call|"Participants were followed up for taking their medication and they were supposed to respond either yes or no. In this outcome measure participants who responded Yes are reported."|First call made anytime from baseline up to 6 months|"Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||Participants|||Count of Participants
2598410|NCT02187042|Secondary|Total Number of Calls (Planned and Unplanned)|1 participant can call more than once during the study.|Baseline up to 6 months|"Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||Calls|||Number
2598411|NCT02187042|Secondary|"Number of Investigating Physicians Who Reported Themselves Being Satisfied or Very Satisfied With the Management By the Telephone Call Center"|"Physicians' satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 item. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of physicians who were either Satisfied or Very Satisfied for overall satisfaction were reported."|Baseline up to 6 months|Analysis population included all investigating doctors/physicians who completed a satisfaction questionnaire to assess the management of follow-up of participants by the call center. For this outcome measure ‘Participant’ refers to ‘investigating physician’|||Physicians|||Number
2598412|NCT02187042|Secondary|Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire|"Physician's satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 items. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension have been completed (and are not no opinion). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction."|At the end of the study (At Month 6)|Analysis population included all investigating doctors/physicians who completed a satisfaction questionnaire to assess the management of follow-up of participants by the call center. For this outcome measure ‘Participant’ refers to ‘investigating physician’.|||Units on a scale||Standard Deviation|Mean
2598413|NCT02187042|Secondary|"Number of Participants Who Reported Themselves Being Satisfied or Very Satisfied With the Management By the Telephone Call Center"|"Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction concerning advice: have 3 item, 2) Satisfaction concerning management: 1 items, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of participants who were either Satisfied or Very Satisfied for overall satisfaction were reported."|At the end of the study (At Month 6)|Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who were followed up by call center and completed a self-administered satisfaction questionnaire about management by call center.|||Participants|||Count of Participants
2598440|NCT02187029|Secondary|Number of Participants Reaching Serum Uric Acid Levels <6, <5 and <4 mg/dL at 24 Hours Post Dose on Day 7 and Day 14|Number of participants reaching serum uric acid levels <6, <5 and <4 mg/dL at 7 and 14 days after initiation.|24 hours post dose on Day 7 and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment.|||participants|||Number
2598414|NCT02187042|Secondary|Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire|"Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction with advice: 3 item, 2) Satisfaction with care, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension had been completed (and are not no opinion). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction."|At the end of the study (At Month 6)|Analysis population: participants who were investigated by the doctors, who met study eligibility criteria, had received at least 1 dose of Sunitinib and were followed up by call center and completed a self-administered satisfaction questionnaire about management by call center. Here, ‘Number analyzed’ = participants evaluable for specified rows.|||Units on a scale||Standard Deviation|Mean
2598415|NCT02187042|Secondary|Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Best Response|ORR used for the assessment of response to treatment. As per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimetre [mm]). No new lesions. Partial response (PR) was defined as greater than or equal to (>=) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline up to 6 months|Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Data was collected only for the reporting arm “call center” as per the planned analysis.|||Percentage of participants|||Number
2598416|NCT02187042|Secondary|Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score|"MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either Yes or No; Yes =1 and No =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. High adherence: score of 0, average adherence: score of 1 or 2, poor adherence: score of 3 or 4."|Baseline up to 6 months|"Safety population included participants treated with Sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||Units on a scale||Standard Deviation|Mean
2598417|NCT02187042|Secondary|"Number of Participants Who Were Adherent as Per 4- Item Morisky Medication Adherence Scale (MMAS-4)"|"MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either Yes or No; Yes =1 and No =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. Adherent participants were defined as participants with an MMAS-4 score of 0."|Baseline up to 6 months|"Safety population included participants treated with Sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||Participants|||Count of Participants
2598418|NCT02187042|Secondary|Number of Participants With At Least 1 Unplanned Consultation|Number of participants with at least 1 unplanned consultations either related or unrelated to sunitinib were reported.|Baseline up to 6 months|Analysis population included included participants who were treated with sunitinib and had follow up by call center along with conventional method. Data was collected only for the reporting arm “call center” as per the planned analysis.|||Participants|||Count of Participants
2598419|NCT02187042|Secondary|Number of Participants With At Least 1 Unplanned Hospitalization|Number of participants with at least 1 unplanned hospitalizations either related or unrelated to sunitinib were reported.|Baseline up to 6 months|Analysis population included participants who were treated with Sunitinib and had follow up by call center along with conventional method. Data was collected only for the reporting arm “call center” as per the planned analysis.|||Participants|||Count of Participants
2598420|NCT02187042|Secondary|Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles|Last treatment cycle was declared by doctor either on the notified date to discontinue sunitinib or on the date of the last consultation if sunitinib treatment was not stopped|Baseline up to 6 months|Safety population included participants treated with Sunitinib.|||Participants|||Count of Participants
2598421|NCT02187042|Secondary|Mean Duration of Sunitinib Treatment|Total mean duration (in months) of sunitinib treatment is reported in this outcome measure.|Baseline up to 6 months|Safety population included participants treated with Sunitinib.|||Months||Standard Deviation|Mean
2598422|NCT02187042|Secondary|Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation|Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.|Baseline up to 6 months|"Safety population included participants treated with Sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||Participants|||Count of Participants
2598423|NCT02187042|Secondary|Number of Participants Who Permanently Discontinued Sunitinib Treatment|Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant.|Baseline up to 6 months|Safety population included participants treated with Sunitinib.|||Participants|||Count of Participants
2598441|NCT02187029|Secondary|Change From Baseline in Serum Uric Acid Levels at Day 1, Day 3, Day 7, Day 11, Day 14 and Follow-up||Day 1, Day 3, Day 7, Day 11, Day 14 and follow-up visit (Day 25-29)|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.|||mg/dL||Standard Deviation|Mean
2598424|NCT02187042|Secondary|Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption|Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor. Participants were counted in more than 1 category.|Baseline up to 6 months|"Safety population included participants treated with Sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||Participants|||Count of Participants
2598425|NCT02187042|Secondary|Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment|Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.|Baseline up to 6 months|"Safety population included participants treated with Sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||days||Standard Deviation|Mean
2598426|NCT02187042|Secondary|Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment|Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor.|Baseline up to 6 months|Safety population included participants treated with Sunitinib.|||Participants|||Count of Participants
2598427|NCT02187042|Secondary|Average Sunitinib Dose Reduction||Baseline up to 6 months|"Safety population included participants treated with Sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||milligram per day (mg/day)||Standard Deviation|Mean
2598428|NCT02187042|Secondary|Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction|Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose according to the reasons for dose reductions are reported.|Baseline up to 6 months|"Safety population included participants treated with Sunitinib. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||Participants|||Count of Participants
2598429|NCT02187042|Secondary|Number of Participants With at Least 1 Sunitinib Dose Reduction|Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose are reported.|Baseline up to 6 months|Safety population included participants treated with Sunitinib.|||Participants|||Count of Participants
2598430|NCT02187042|Primary|Number of Participants With at Least 1 Adverse Event (AE) of Grade 3 or 4 Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was death related to AE.|Baseline up to 6 months|Safety population included participants treated with Sunitinib.|||Participants|||Count of Participants
2598431|NCT02187029|Secondary|Change From Baseline in Urinary Hypoxanthine Levels at Day 1, Day 7, and Day 14|Change from baseline in urinary hypoxanthine cumulative amounts at Day 1, Day 7 and Day 14|Baseline, Day 1, Day 7 and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.|||mg||Standard Deviation|Mean
2598432|NCT02187029|Secondary|Change From Baseline in Urinary Xanthine Levels at Day 1, Day 7, and Day 14|Change from baseline in urinary xanthine cumulative amounts.|Baseline, Day 1, Day 7 and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.|||mg||Standard Deviation|Mean
2598433|NCT02187029|Secondary|Change From Baseline in Urinary Uric Acid Levels at Day 1, Day 7, and Day 14|Change from baseline in urinary uric acid cumulative amounts.|Baseline, Day 1, Day 7 and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.|||mg||Standard Deviation|Mean
2598434|NCT02187029|Secondary|Change From Baseline in Plasma Levels of Hypoxanthine at Day 1, Day 7, Day 14, and at Follow-up||Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.|||mcg/mL||Standard Deviation|Mean
2598435|NCT02187029|Secondary|Change From Baseline in Plasma Levels of Xanthine at Day 1, Day 7, Day 14, and at Follow-up|Change in plasma levels of xanthine from baseline at time points 0 (prior to dosing except on Day 1), 1, 2, 4, 8, 12 and 24 hours following dosing with PF-06743649 or placebo on days 1, 7 and 14 as well prior to dosing on days 3 and 11 and at follow-up of treatment with PF-06743649 or placebo.|Baseline, Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
2598436|NCT02187029|Secondary|Plasma Levels of PF-06743648 After Initiation of Dosing at Day 1, Day 7, and Day 14|PF-06743648 is an active metabolite of PF-06743649. Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 2.00 nanograms per milliliter (ng/mL).|Day 1, Day 7, and Day 14|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.|||ng/mL||Standard Deviation|Mean
2598437|NCT02187029|Secondary|Plasma Levels of PF-06743649 After Initiation of Dosing at Day 1, Day 7, and Day 14|Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 10.0 nanograms per milliliter (ng/mL).|0, 1, 2, 4, 8, 12 and 24 hours at Day 1, Day 7, and Day 14|All participants randomized and treated who have at least 1 measureable concentration; n=number of participants analyzed in each respective arm.|||ng/mL||Standard Deviation|Mean
2598438|NCT02187029|Secondary|Duration of Gout Flare Attacks|Duration of gout flare attacks with participants who developed gout flare attacks.|Baseline up to Day 42|Participants who developed gout flare attacks (Duration was not assessed as no participant developed gout flare attacks).||||||
2598442|NCT02187029|Primary|Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria|Criteria for potential clinically important changes in ECG (12-lead) were defined as: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval) >=300 milliseconds (msec) or increase from baseline >=25% when baseline >200 msec or increase from baseline >=50% when baseline less than or equal to (<=) 200 msec; time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec or >=50% increase from baseline; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) of 450 to < 480 msec, 480 to <500 msec and >=500 msec, or an increase of 30 to <60 msec or >=60 msec from baseline.|Baseline up to Day 16|The safety analysis population included all participants who received at least 1 dose of study medication.|||participants|||Number
2598443|NCT02187029|Primary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Criteria for potential clinically important change in vital signs included: Systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg) or more than or equal to (>=)30 mmHg change from baseline, diastolic BP of <50 mmHg or >=20 mmHg change from baseline, Supine pulse rate of <40 or more than (>)120 beats per minute (bpm).|Baseline up to follow up visit (Day 25-29)|The safety analysis population included all participants who received at least 1 dose of study medication.|||participants|||Number
2598444|NCT02187029|Primary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters include hematology (Hemoglobin, Hematocrit, red blood cell [RBC] count, Platelet count, mean corpuscular volume [MCV], mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration [MCHC], white blood cell [WBC] count, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes), hematocrit (blood urea nitrogen [BUN]/urea and Creatinine, Glucose , Calcium, Sodium, Potassium, Chloride, Total CO2 [Bicarbonate], aspartate transaminase [AST], alanine transaminase [ALT], Total Bilirubin, Alkaline phosphatase, Albumin, Total protein, Thyroid Stimulating Hormone [TSH], free T3 [FT3] and free T4 [FT4] ), urinalysis (pH, Glucose [qual], Protein, Blood, Ketones, Nitrites, Leukocyte esterase, Urobilinogen, Urine bilirubin, Microscopy [including crystals]) and other (follicle-stimulating hormone [FSH], Urine drug screen).|Baseline up to follow up visit (Day 25-29)|The safety analysis population included all participants who received at least 1 dose of study medication.|||participants|||Number
2598445|NCT02187029|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state AEs included both serious and non-serious events.|Baseline up to 28 days after last study drug administration (Day 42)|The safety analysis population included all participants who received at least 1 dose of study medication.|||participants|||Number
2598446|NCT02187029|Primary|Percent Change From Baseline in Serum Uric Acid Level at 24 Hours Post Dose on Day 14||Day 14 Hour 24|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment. Number of participants analyzed is number of evaluable participants for this outcome measure. No data due to “Cohort 2: PF-06743649 5 mg” termination after 2 days of dosing.|||percent (%)||Standard Deviation|Mean
2598447|NCT02187029|Primary|Baseline of Serum Uric Acid|An elevation in serum uric acid, hyperuricemia, is a prerequisite for the development of gout.|Baseline (pre-dose Day 1)|The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment.|||milligram per deciliter(mg/dL)||Standard Deviation|Mean
2598448|NCT02187016|Secondary|Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28|RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).|28 days||||units on a scale||Standard Error|Least Squares Mean
2598449|NCT02187016|Secondary|Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14|RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).|14 days||||units on a scale||Standard Error|Least Squares Mean
2598450|NCT02187016|Secondary|Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28|GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).|28 days||||units on a scale||Standard Error|Least Squares Mean
2598451|NCT02187016|Secondary|Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14|GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).|14 days||||units on a scale||Standard Error|Least Squares Mean
2598452|NCT02187016|Secondary|Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28|MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation).|28 days||||units on a scale||Standard Error|Least Squares Mean
2598453|NCT02187016|Primary|Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14|MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).|14 days||||units on a scale||Standard Error|Least Squares Mean
2598454|NCT02186938|Secondary|Number of Participants Requiring a Ventilator|The secondary outcome is decreasing patient morbidity by comparing the number of patients on the ventilator|The number of participants requiring a ventilator after surgery.||||participants|||Number
2598455|NCT02186938|Primary|ICU Stay|The primary outcome is length of ICU stay.|Participants were assessed from entry into ICU until departure.||||hours||Full Range|Mean
2598650|NCT02183792|Other Pre-specified|Mean Hourly Urine Output at 24 Hours||Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days|||||||
2598456|NCT02186873|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16|BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: tragus to wall distance, lumbar flexion, cervical rotation, lumbar side flexion, and intermalleolar distance. Each measure was scored 0-2 (0=normal mobility/mild disease involvement, 1=moderate disease involvement, 2=severe disease involvement) to give a final total BASMI score ranging from 0 to 10. The higher the BASMI score, the more severe was the participant's limitation of movement due to their AS.|Baseline and Week 16|FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on Scale||Standard Deviation|Mean
2598457|NCT02186873|Secondary|Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16|"The ASQoL is a self-administered health-related quality of life (HRQOL) instrument. It consists of 18 items requesting a Yes or No response to questions related to the impact of the disease/condition (including pain) on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. A score of 1 is given to a response of yes on each item and all item scores are summed to a total score with a range of 0 to 18. Higher scores indicate worse HRQOL."|Baseline and Week 16|FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on Scale||Standard Deviation|Mean
2598458|NCT02186873|Secondary|Percentage of Participants With Low Level of Disease Activity (ASAS Partial Remission) at Week 16|Low level of disease activity was measured by criteria for ASAS partial remission, defined as a value below 2 on a scale of 0 to 10 cm in each of the 4 ASAS domains: patient's global assessment of disease activity, total back pain, function (BASFI), inflammation.|Week 16|FAS included all participants who were randomized in the study.|||Percentage of Participants|||Number
2598459|NCT02186873|Secondary|Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16|The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score(vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.|Baseline and Week 16|FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a Scale||Standard Deviation|Mean
2598460|NCT02186873|Secondary|Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16|The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score (vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10.|Baseline and Week 16|FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a Scale||Standard Deviation|Mean
2598461|NCT02186873|Primary|Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16|ASAS 20 defined as 20 percent (%) improvement compared to baseline in the ASAS Working Group criteria: that is, greater than or equal to (>=)20% improvement from baseline in at least 3 of the 4 domains: patient's global assessment of disease activity (0=very well,10 =very poor), total back pain (0=no pain,10=most severe pain), function (self-assessment using BASFI [0=no functional impairment to 10= maximal impairment]), inflammation (0=none,10=very severe) with an absolute improvement of at least 1 (0-10 centimeter (cm) visual analogue scale [VAS]), and an absence of deterioration (defined as >=20% worsening and absolute worsening of at least 1 on a 0-10 cm scale) in the potential remaining domain.|Week 16|The full analysis set (FAS) included all participants who were randomized in the study.|||Percentage of Participants|||Number
2598462|NCT02186873|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 16|The BASFI is a participant's self-assessment of physical function represented as a mean of 10 questions, each question rated on VAS 0 to 10 cm (VAS 0 to 10 cm; 0=easy to 10=impossible), 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life.|Baseline and Week 16|FAS included all participants who were randomized in the study. Here, 'N' (Number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a Scale||Standard Deviation|Mean
2598463|NCT02186873|Secondary|Percentage of Participants Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16|The BASDAI is a self-assessment tool to determine disease activity using a VAS of 0-10 cm (0=none and 10=very severe) participant's answered 6 questions measuring fatigue, spinal pain, joint pain, enthesitis, and morning stiffness. The final BASDAI is calculated as a mean of individual questions with a final score range of 0 to 10 cm; 0=best and 10=worst.|Week 16|FAS included all participants who were randomized in the study.|||Percentage of Participants|||Number
2598464|NCT02186873|Secondary|Percentage of Participants Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16|An ASAS 40 response is defined as >=40% improvement from baseline in 3 of 4 domains: patient's global assessment of disease activity (0=very well, 10=very poor), total back pain (0=no pain, 10=most severe pain), function (self-assessment using BASFI (0=no functional impairment to 10=maximal impairment), inflammation (0=none, 10=very severe) with an absolute improvement of at least 2 (0-10 cm VAS), and no deterioration in the remaining domain.|Week 16|FAS included all participants who were randomized in the study.|||Percentage of Participants|||Number
2598651|NCT02183792|Other Pre-specified|In-hospital Mortality||Participants will be followed for the duration of hospital stay, an expected average of 5 days|||||||
2598465|NCT02186834|Primary|Overall Response Rate (ORR) -All Participants Treated at Recommended Phase 2 Dose|Determine the overall response rate per the modified uniform response criteria of the International Myeloma Working Group (IMWG), partial response and better. Partial Remission (PR): >/= 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by >/= 90% or to < 200 mg per 24 hours; Very Good Partial Remission (VGPR): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours; Complete Remission (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and </= 5% plasma cells in bone marrow.|Up to 24 months|All participants treated at recommended phase 2 dose, regardless of when they joined the study.|||Participants|||Count of Participants
2598466|NCT02186834|Primary|Overall Response Rate (ORR) - All Participants|ORR per the modified uniform response criteria of the International Myeloma Working Group (IMWG), partial response and better. Partial Remission (PR): >/= 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by >/= 90% or to < 200 mg per 24 hours; Very Good Partial Remission (VGPR): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours; Complete Remission (CR): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and </= 5% plasma cells in bone marrow. Stable Disease: Not meeting criteria for CR, VGPR, PR, or progressive disease. Minimal response: Less than 50% decrease in M protein. Not evaluable: Cannot be measured because enough information has not been collected.|Up to 24 months|All participants|||Participants|||Count of Participants
2598467|NCT02186834|Primary|Maximum Tolerated Dose (MTD)|"Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D): Selinexor on Days 1, 8 and 15 when given in combination with Lipodox 20 mg/m^2 and Dexamethasone 40 mg.~Dose level 1: 40 mg in combination with Lipodox and Dexamethasone.~Dose level 2: 80 mg (D1,8,15) in combination with Lipodox and Dexamethasone.~Dose level 2m: 80 mg (D1,8,15) in combination with Lipodox and Dexamethasone.~Dose level 3m: 80 mg (D1,3,8,10) in combination with Lipodox and Dexamethasone."|Up to 12 months|All participants treated during dose escalation|||mg|||Number
2598468|NCT02186808|Secondary|Success Rate of Bridge Procera Bridge Zirconia|The CDA index (1) is Romeo or Sierra at delivery and remains so 5 year post loading.|prosthesis delivery, 5 years|5 year data. Not all initially treated patients could be followed over the 5 years.|||percentage of successful implants|Participants||Number
2598469|NCT02186808|Primary|Success Rate of Bridge Procera Bridge Zirconia|The CDA index (1) is Romeo or Sierra at delivery and remains so up to 1 year post loading.|prosthesis delivery, 1 year|78 patients were treated in total. 4 of the patients received two bridges (which is complaint with the protocol). Therefore there are more bridges than patients.|||percentage of successful implants|Participants||Number
2598470|NCT02186795|Primary|Opiate Consumption|Cumulative 48 Hours Opiate Consumption in Intravenous (IV) Morphine mg Equivalents (MME)|48 hours postoperative||||IV MME||Standard Error|Mean
2598471|NCT02186665|Primary|Success of Investigator's Global Assessment (IGA)|"The number of subjects with a minimum improvement of 2 grades from baseline in the IGA score and a severity rating of 0 (clear) of 1 (almost clear) at Week 8 (LOCF).~The IGA was evaluated at each visit on the following 0 to 4 point scale:~0 - Clear: No signs of psoriasis except for residual hypopigmentation / hyperpigmentation~- Almost Clear: Just perceptible erythema, no induration, and no scaling~- Mild: Mild erythema, no induration, and mild or no scaling~- Moderate: Moderate erythema, mild induration, and mild or no scaling~- Severe: Severe erythema, moderate to severe induration, and scaling of any degree"|Baseline to Week 8|ITT: All randomized subjects to whom study medication was dispensed.|||Participants|||Count of Participants
2598472|NCT02186652|Secondary|The CYP2C19 Genotype and Its Association With CYP2C19 Phenotype|To examine the association of CYP2C19 genotype and its association with CYP2C19 phenotypes. To characterize the ability of the CYP2C19 genotype to predict pantoprazole plasma clearance, a correlation with CYP2C19 phenotype was explored using both standard linear and nonlinear regression techniques and their respective tests for significance and goodness of fit. In addition, the impact of all covariates on pantoprazole systemic exposure and apparent plasma clearance (e.g., demographic determinants of extent of obesity such as the waist:hip ratio, CYP2C19 genotype, BMI, and REE) was explored using validated population-based PK methods (NONMEM).|0, 1, 2, 3, 4, 6, 8, 12 hours post-dose|"Total analyzed #participants is 38. Total #participants in age groups is 37 excluding one poor-metabolizer.~Poor metabolizer is defined as a participant who had *2/*2 alleles; intermediate metabolizer is defined as a participant who had *1/*2 or *2/*17 alleles; extensive metabolizer is defined as a participant who had *1/*1 or *1/*17 alleles."|||L/h||Full Range|Median
2598473|NCT02186652|Primary|Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).|The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Vd/F LBW.|pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours|All participants with evaluable data.|||L/kg LBW||Standard Deviation|Mean
2598474|NCT02186652|Primary|Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F).|The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Vd/F TBW.|pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours|All participants with evaluable data.|||L/kg TBW||Standard Deviation|Mean
2598475|NCT02186652|Primary|Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (CL/F).|The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report CL/F TBW.|pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours|All participants with evaluable data.|||l/h/kg TBW||Standard Deviation|Mean
2598491|NCT02186509|Primary|Maximum Tolerated Dose (MTD) of Alisertib|Defined as the dose at which >= 2 patients experience dose-limiting toxicity, graded in severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0|Up to 30 days after completion of radiation therapy||||mg dose of Alisertib|||Number
2598476|NCT02186652|Primary|Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).|The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report AUC LBW.|pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours|All participants with evaluable data.|||mcg*h/mL||Standard Deviation|Mean
2598477|NCT02186652|Primary|Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC).|The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report AUC TBW.|pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours|All participants with evaluable data.|||mcg*h/mL||Standard Deviation|Mean
2598478|NCT02186652|Primary|Drug Concentration in Plasma Samples|Concentration of panto in plasma and concentration of panto sulfone in plasma|Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing|All participants with evaluable data|||ng/ml|plasma samples|Standard Deviation|Mean
2598479|NCT02186652|Primary|PK Sampling|Total number of fresh plasma samples (all participants)|Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing|All participants with evaluable data|||Plasma samples|Plasma samples|Standard Deviation|Mean
2598480|NCT02186652|Primary|Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Tmax).|The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Tmax.|pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours|All participants with evaluable data.|||hours||Full Range|Median
2598481|NCT02186652|Primary|Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax).|The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Cmax.|pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours|All participants with evaluable data.|||mcg/ml||Standard Deviation|Mean
2598482|NCT02186587|Primary|Distance Measured During 6-minute Walk Test|Subjects will walk for 6 minutes and the distance covered will be measured in feet.|6 months||||feet||Standard Deviation|Mean
2598483|NCT02186561|Secondary|The Number of Participants With Successfully Deployed Investigational Device|The secondary outcome measures provides the number of participants successfully implanted with the Investigational device during the study index procedure at the target site.|Index Procedure|Participants Enrolled who Underwent the Index Procedure|||Participants|||Count of Participants
2598484|NCT02186561|Secondary|The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage > 30 Days Post-Procedure|For the purpose of this protocol, delayed intracerebral hemorrhage was defined as hemorrhage within the fixed vault of the cranium (skull) occurring greater than 30 days post-procedure.|> 30 days, Post Procedure|ParticipantsTreated with the Investigational Device that Completed the 30 Day Visit|||Participants|||Number
2598485|NCT02186561|Secondary|The Number of Participants With a Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 30-days Post Procedure Due to Procedural Complications|Major Stroke is defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Neurological death is any subject death due to neurologic reasons.|Up to 30 days, Post Procedure|Participants Treated with the Investigational Device that Completed the 30 Day Visit|||Participants|||Count of Participants
2598486|NCT02186561|Primary|The Percentage of Participants With Complete Aneurysm Occlusion (Defined as Raymond Roy Grade 1) Without Significant Parent Artery Stenosis (≤ 50%) or Retreatment of the Target Aneurysm at 12-Months Post-Procedure|"The definitions for the three components of the primary effectiveness endpoint were: 1) retreatment, defined as all retreatment procedures occurring between the index procedure and 1 Year post-procedure; 2) complete aneurysm occlusion based on Core Laboratory review of 1-year images and 3) significant parent artery stenosis, based on Core Laboratory review of 1-year images. The Raymond-Roy Grading scale is used for judging intracranial aneurysm (IA) endosaccular embolization success. Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac.~Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination."|Up to 12 Months Post Procedure|Participants Treated with Investigational Device that Completed the 12 Month Visit Imaging|||Percentage of Participants|||Number
2598487|NCT02186561|Primary|The Percentage of Participants With the Occurrence of Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 12-Months Post Procedure|The primary safety endpoint was defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Missing data for subjects who failed to complete the 12- month post-procedure evaluation without any evidence of a major stroke in the territory supplied by the treated artery or neurological death were imputed in the analysis using multiple imputation. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination.|Up to 12 Months Post Procedure|Participants enrolled and implanted with the Investigational Device (ITT)|||percentage of participants|||Number
2598488|NCT02186509|Secondary|Number of Participants With Overall Survival at 6 Months|Estimated through the Kaplan-Meier method.|At 6 months||||Participants|||Count of Participants
2598489|NCT02186509|Secondary|Number of Participants With Progression Free Survival at 6 Months|Estimated through the Kaplan-Meier method.|At 6 months||||Participants|||Count of Participants
2598490|NCT02186509|Secondary|Number of Participants With Complete or Partial Response|95% confidence intervals will be computed. Response was defined by the Updated Response Assessment Criteria for High-Grade Gliomas: Response Assessment in Neuro-Oncology Work Group (RANO)|Up to 5 years||||Participants|||Count of Participants
2598493|NCT02186301|Secondary|Confirmed Response Rate|"Proportion of patients with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression or recurrence.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as:~Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.~Partial Response (PR),at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.~Overall Response (OR),is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment was dependent on the achievement of both measurement and confirmation criteria."|Cycle 1 Day 1 to End of Treatment, up to approximately 35 months.|Intent-to-treat: All patients randomized|||percentage of participants||95% Confidence Interval|Number
2598494|NCT02186301|Primary|Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)|To compare the antitumor efficacy of oral single-agent rociletinib with that of erlotinib as measured by progression-free survival (PFS), when administered as a first-line targeted treatment to patients with EGFR-mutated, advanced NSCLC.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression.|Cycle 1 Day 1 to End of Treatment, up to approximately 35 months|"Intent-to-treat: All patients randomized.~1 patient was not included in analysis, due to discontinuation of study shortly after randomization and prior to first dose of study drug."|||Days||95% Confidence Interval|Median
2598495|NCT02186223|Secondary|Incidence of PEs Averted|During the pre-removal cavogram, the presence of significant clot (>25% of the volume of the filter) trapped by the Angel® Catheter will be assessed. The number of subjects with significant clot trapped by the device will be reported as the number of PEs averted.|During the pre-removal cavogram (An average of 6.8 days after device insertion)||||Participants|||Count of Participants
2598496|NCT02186223|Secondary|Incidence of Major Bleeding Event||Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)||||Participants|||Count of Participants
2598497|NCT02186223|Secondary|Incidence of Catheter Related Blood Stream Infections||Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)||||Participants|||Count of Participants
2598498|NCT02186223|Secondary|Incidence of Catheter Related Thrombosis||Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)||||Participants|||Count of Participants
2598499|NCT02186223|Secondary|Incidence of Acute Proximal Deep Vein Thrombosis||Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever occurs first (maximum of 33 assessment days with an anticipated average of 7 days)||||Participants|||Count of Participants
2598500|NCT02186223|Primary|Freedom From Clinically Significant PE or Fatal PE During Treatment Period|"Clinically Significant PE: Subjects will be assessed daily for signs and symptoms of PE. If present and no alternative diagnosis is suspected, at least one of four defined diagnostic examinations will performed to confirm or rule out PE.~Fatal PE: Defined as unexpected death within 24 hours of onset of the acute event with a verified initial symptomatic DVT or PE where there is no other reasonable cause of death."|Assessed daily from Baseline through Study Exit which occurs 3 days post-Angel Catheter Removal OR at hospital discharge, whichever is first (maximum of 33 assessment days with an anticipated average of 7 days)||||Participants|||Count of Participants
2598501|NCT02186210|Secondary|Tissue Oxygen Saturation||During the surgery, an average of 4 hours||||% (percent of tissue saturation)||Standard Deviation|Mean
2598502|NCT02186210|Primary|Recovery Slope|We will compare recovery slope assessed 3 hours after induction of anesthesia to evaluate the effect of prewarming during induction of anesthesia on microcirculation.|3 hours after induction of anesthesia||||% / sec (recovery slope unit)||Standard Deviation|Mean
2598503|NCT02186171|Secondary|Percent Change From Baseline in BMD at the Femoral Neck at Month 6|Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and month 6|Primary efficacy analysis subset with available data at baseline and month 6.|||percent change||Standard Error|Least Squares Mean
2598504|NCT02186171|Secondary|Percent Change From Baseline in BMD at the Total Hip at Month 6|Bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and month 6|Primary efficacy analysis subset with available data at baseline and month 6.|||percent change||Standard Error|Least Squares Mean
2598505|NCT02186171|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 6|Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and month 6|Primary efficacy analysis subset with available data at baseline and month 6.|||percent change||Standard Error|Least Squares Mean
2598506|NCT02186171|Secondary|Percent Change From Baseline in BMD at the Femoral Neck at Month 12|Femoral neck bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and month 12|Primary efficacy analysis subset, which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the femoral neck; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
2598507|NCT02186171|Secondary|Percent Change From Baseline in BMD at the Total Hip at Month 12|Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and month 12|Primary efficacy analysis subset, which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the total hip; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
2598508|NCT02186171|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12|Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and month 12|Primary efficacy analysis subset, which includes all randomized participants who had a baseline DXA BMD measurement and at least 1 post-baseline DXA BMD measurement at the lumbar spine; last observation carried forward (LOCF) imputation was used.|||percent change||Standard Error|Least Squares Mean
2598509|NCT02185729|Primary|Flow Mediated Dilation|Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter − 24 hour diameter)/24 hour diameter × 100.|24 hours after infusion||||percentage of brachial artery diameter||Standard Error|Mean
2598510|NCT02185729|Primary|Flow Mediated Dilation|Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter − 4 hour diameter)/4 hour diameter × 100.|4 hours after infusion||||percentage of brachial artery diameter||Standard Error|Mean
2598511|NCT02185729|Primary|Flow Mediated Dilation|Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter − baseline diameter)/baseline diameter × 100.|Baseline||||percentage of brachial artery diameter||Standard Error|Mean
2598512|NCT02185534|Secondary|Pharmacokinetics of Clopidogrel by Assessment of Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC(0-last))|Comparison of the pharmacokinetic profile in terms of the area under the plasma concentration-curve from time zero to the time of last quantifiable clopidogrel or SR26334 concentration, AUC(0-last), of clopidogrel sourced in Europe and the US.|0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose|The pharmacokinetic population consisted of 79 subjects, i.e. all subjects in the safety population for whom AUC(0-last) and Cmax could be calculated for clopidogrel for the test treatment (European) and at least one of the reference treatments (Japanese, US)|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2598513|NCT02185534|Primary|Pharmacokinetics of Clopidogrel by Assessment of Observed Maximum Plasma Concentration (Cmax)|Comparison of the pharmacokinetic profile in terms of observed maximum plasma concentration, taken directly from the individual concentration-time curve, Cmax, of clopidogrel sourced in Europe and the US.|0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose|The pharmacokinetic population consisted of 79 subjects, i.e. all subjects in the safety population for whom AUC(0-last) and Cmax could be calculated for clopidogrel for the test treatment (European) and at least one of the reference treatments (Japanese, US)|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2598514|NCT02185534|Primary|Pharmacokinetics of Clopidogrel by Assessment of Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf))|Comparison of the pharmacokinetic profile in terms of plasma concentration-time curve from time zero extrapolated to infinity, AUC(0-inf), of clopidogrel sourced in Europe and Japan.|0 hours (pre-dose), as well as at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 36 hours post-dose|The pharmacokinetic population consisted of 79 subjects, i.e. all subjects in the safety population for whom AUC(0-last) and Cmax could be calculated for clopidogrel for the test treatment (European) and at least one of the reference treatments (Japanese, US). AUC(0-inf) could not be reliably calculated for many of these subjects.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2598515|NCT02185521|Secondary|Intensive Care Unit (ICU) Mortality||From date of randomization of the study subject until the date of ICU discharge, an average of 6.7 days..||||Participants|||Count of Participants
2598516|NCT02185521|Primary|Intensive Care Unit (ICU) Length of Stay||From time of the study subject admission to the unit until the day of discharge of that same study subject from the unit, assessed up to 12 months.||||days||Standard Deviation|Mean
2598517|NCT02185339|Other Pre-specified|Postoperative Pain|"Postoperative pain was measured by Visual Analogue Scale (VAS). Participants were asked to report their level of pain by pointing to a horizontal line, 10 cm in length. The scale (0-10 scores) was anchored by no pain (score of 0) and pain as bad as it could be (score of 10).~Measurements were made at postoperative (PO) 1h, PO 2h, PO 6h, PO 24h, and PO 48h."|Postoperative 2 days||||Scores on a scale||Standard Deviation|Mean
2598518|NCT02185339|Other Pre-specified|Surgical Condition|Subjective rating of the view on the operating field was assessed by the surgeon who performed the surgery (optimal condition, good, acceptable, poor, extremely poor)|At completion of pneumoperitoneum surgery||||Participants|||Number
2598519|NCT02185339|Other Pre-specified|Cardiac Index|"Was obtained from arterial pressure waveform analysis using the FloTrac™ sensor and the Vigileo™ monitor.~Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP."|intraoperative||||L/min/m^2||Standard Deviation|Mean
2598520|NCT02185339|Other Pre-specified|Stroke Volume Variation|"Was calculated by taking '(maximum stroke volume - minimum stroke volume) / mean stroke volume' over a respiratory cycle using the FloTrac™ sensor and the Vigileo™ monitor.~Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP."|intraoperative||||% of mean stroke volume||Standard Deviation|Mean
2598521|NCT02185339|Secondary|Pulmonary Shunt|"Was calculated using the formula: pulmonary shunt = (pulmonary capillary oxygen content - arterial oxygen content) / (pulmonary capillary oxygen content - venous oxygen content). Pulmonary capillary oxygen partial pressure is assumed to be equal to alveolar oxygen partial pressure.~Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP."|intraoperative||||% of shunt||Standard Deviation|Mean
2598522|NCT02185339|Secondary|Estimated Dead Space|Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.|intraoperative||||% of respiratory dead space||Standard Deviation|Mean
2598523|NCT02185339|Secondary|Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference|Was calculated from arterial blood and expired carbon dioxide analysis. Measurements were obtained at (1) T Lateral, (2) T Lat+PP1h, (3) T Lat+PP2h, and (4) EndPP.|intraoperative||||mmHg||Standard Deviation|Mean
2598525|NCT02185339|Primary|Thoracopulmonary Compliance|"Was measured with a patient spirometry monitor through a flow sensor.~Measurements were obtained at the following four time points: (1) 15 min after a patient positioning in lateral decubitus before inducing the pneumoperitoneum (T Lateral); (2) 1 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP1h); (3) 2 h after pneumoperitoneum induction with the patient in the lateral decubitus position (T Lat+PP2h); and (4) at the end of surgery, 15 min after abdominal deflation in the lateral decubitus position (T EndPP)."|intraoperative||||ml/cmH2O||Standard Deviation|Mean
2598526|NCT02185183|Primary|Number of Participants With Improved in Disease Activity||15 weeks||||participants|||Number
2598527|NCT02185131|Primary|Level of Depressive Symptoms|Level of depressive symptoms, as indicated by the score on the Beck Depression Inventory. The Beck Depression Inventory II scoring range is as follows: 0-13 minimal depressive symptoms, 14-19 mild depressive symptoms, 20-28 moderate depressive symptoms and 29-63 severe depressive symptoms.|12 Weeks||||Units on a scale||Standard Deviation|Mean
2598528|NCT02185131|Primary|Drinks Per Drinking Day|Level of drinking, as indicated by the number of drinks per day as recorded on the Timeline Follow-Back calendar.|12 Weeks||||Drinks per drinking day||Standard Deviation|Mean
2598529|NCT02185105|Primary|Anterior Ocular Health - Conjunctival Staining (Inferior)|Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).|baseline & 6hrs||||units on a scale||Standard Deviation|Mean
2598530|NCT02185105|Primary|Anterior Ocular Health - Conjunctival Staining (Temporal)|Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).|baseline & 6hrs||||units on a scale||Standard Deviation|Mean
2598531|NCT02185105|Primary|Anterior Ocular Health - Conjunctival Staining (Superior)|Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).|baseline & 6hrs||||units on a scale||Standard Deviation|Mean
2598532|NCT02185105|Primary|Anterior Ocular Health - Conjunctival Staining (Nasal)|Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).|baseline & 6hrs||||units on a scale||Standard Deviation|Mean
2598533|NCT02185105|Primary|Anterior Ocular Health - Corneal Staining (Inferior)|Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)|baseline & 6hrs||||units on a scale||Standard Deviation|Mean
2598534|NCT02185105|Primary|Anterior Ocular Health - CornealStaining (Superior)|Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)|baseline & 6hrs||||units on a scale||Standard Deviation|Mean
2598535|NCT02185105|Primary|Anterior Ocular Health - Corneal Staining (Temporal)|Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)|baseline & 6hrs||||units on a scale||Standard Deviation|Mean
2598536|NCT02185105|Primary|Anterior Ocular Health - Corneal Staining (Nasal)|Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)|baseline & 6hrs||||units on a scale||Standard Deviation|Mean
2598537|NCT02185105|Primary|Anterior Ocular Health - Corneal Staining (Central)|Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)|baseline & 6hrs||||units on a scale||Standard Deviation|Mean
2598538|NCT02185105|Primary|Lens Fitting - Rotation/Mislocation|Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-).|Baseline, 15min & 6hrs||||degrees||Standard Deviation|Mean
2598539|NCT02185105|Primary|General Lens Fit - Fit Acceptance|Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)|15min & 6hrs||||units on a scale||Standard Deviation|Mean
2598540|NCT02185105|Primary|Investigator's Assessment of Stability|Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability.|15min & 6hrs||||degrees||Standard Deviation|Mean
2598541|NCT02185105|Primary|Subjective Rating For Handling - Removal|Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)|1 min||||units on a scale||Standard Deviation|Mean
2598542|NCT02185105|Primary|Subjective Rating For Handling - Insertion|Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)|1 min||||units on a scale||Standard Deviation|Mean
2598543|NCT02185105|Primary|Subjective Rating For Comfort Preference|Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)|1min, 15min, 3hrs, 6hrs||||percentage of subjects|||Number
2598544|NCT02185105|Primary|Subjective Rating For Comfort - Comfort Since Last Visit|Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)|15min, 3hrs, 6hrs||||units on a scale||Standard Deviation|Mean
2598545|NCT02185105|Primary|Lens Surface Assessment of Study Lenses - Surface Acceptance|Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)|15min & 6hrs||||units on a scale||Standard Deviation|Mean
2598546|NCT02185105|Primary|Lens Surface Assessment of Study Lenses - Deposits|Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film > 75% of surface)|15min & 6hrs||||units on a scale||Standard Deviation|Mean
2598547|NCT02185105|Primary|Lens Surface Assessment of Study Lenses - Surface Wettability|Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)|15min & 6hrs||||units on a scale||Standard Deviation|Mean
2598548|NCT02185040|Secondary|Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Systemic Lupus Erythematosus (SLICC/ACR SLE) Damage Index Score During the ATEP by Time Point|SLICC/ACR score or damage index is a measure of cumulative damage due to Systemic Lupus Erythematosus (SLE). Damage is defined as nonreversible change (not related to active inflammation) occurring since onset of lupus, ascertained by clinical assessment and present for at least 6 months. Damage is defined for 12 separate organ systems: ocular (range 0-2), neuropsychiatric (0-6), renal (0-3), pulmonary (0-5), cardiovascular (0-6), peripheral vascular (0-5), gastrointestinal (0-6), musculoskeletal (0-7), skin (0-3), endocrine (diabetes) (0-1), gonadal (0-1) and malignancies (0-2). A score of 0=no damage, early damage is defined as ≥1. The total maximum score is 47, and increasing score indicates increasing disease damage severity.|Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.|The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.|||Units on a Scale||Standard Deviation|Mean
2598549|NCT02185040|Secondary|Change From Baseline in the Cutaneous Lupus Area and Severity Index (CLASI) Damage Score During the ATEP by Time Point|The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity.|Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.|The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.|||Units on a Scale||Standard Deviation|Mean
2598550|NCT02185040|Secondary|Change From Baseline in the Fatigue Visual Analog Scale (VAS) During the ATEP by Time Point|"The Fatigue VAS evaluates SLE-related fatigue using a 0 to 100 mm VAS scale. The Fatigue VAS allowed the participant to indicate the degree of SLE-related fatigue by placing an X representing how they feel, along a visual analog line that extends between two extremes (e.g., from not at all tired to extremely tired) over the previous week. A decrease in the fatigue VAS indicates improvement."|Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.|The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.|||Units on a Scale||Standard Deviation|Mean
2598551|NCT02185040|Secondary|Change From Baseline in the Pericardial/Pleuritic Pain Scale During ATEP by Time Poimt|The pericardial/pleuritic pain scale was scored using numerical values of 1 through 10 with 1 representing 'no pain' and 10 representing 'worst possible pain'. These were self-administered by the participants and gauged the severity of their SLE pain related to pericardial and pleuritic discomfort. Any indication from participants or study assessments, aside from pain, which indicated clinically significant pericardial or pleuritic manifestations of SLE was thoroughly investigated; if clinically significant SLE related complications were found, the participants was to be discontinued from the study and entered into the Observational Follow-up Period and treated appropriately.|Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.|The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.|||Units on a Scale||Standard Deviation|Mean
2598552|NCT02185040|Secondary|Change From Baseline in the British Isles Lupus Assessment Group (BILAG) 2004 Global Score During the ATEP by Time Point|The BILAG-2004 index measures clinical disease activity in systemic lupus erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 9 domains (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematologic). BILAG A represents the most active disease or severe disease; BILAG B represents intermediate activity or moderate disease; BILAG C represents stable mild disease; BILAG D represents organ system previously affected but now inactive; and BILAG E represents organ system never involved. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 9 domains. The theoretical range spans from 0 (no activity) to 13 active or severe disease activity BILAG. A higher score means more severe disease activity while a lower score means lower disease activity (or no disease activity for score of zero).|Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.|The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.|||Units on a Scale||Standard Deviation|Mean
2598553|NCT02185040|Secondary|Change From Baseline in the Physician's Global Assessment (PGA) Score During the ATEP by Time Point|"The physician's global assessment was administered by the treating physician and was used to gauge the participants overall state of health. The instrument uses a visual analogue scale with scores between 0 and 3 to indicate worsening of disease. The scoring is as follows:~0 = none~1 = mild disease~2 = moderate disease~3 = severe disease"|Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.|The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.|||Units on a Scale||Standard Deviation|Mean
2598561|NCT02185040|Secondary|Maximum Observed Concentration (Cmax) Of Iberdomide|Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.|Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.|The PK population included all participants in the safety population with at least one non-missing plasma concentration datum available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2598652|NCT02183792|Other Pre-specified|Glomerular Filtration Rate (Estimated)||Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days|||||||
2598554|NCT02185040|Secondary|Percent Change From Baseline in Cutaneous Lupus Area and Severity Index (CLASI) Activity Score During the ATEP by Time Point|The CLASI Activity Score ranges from 0 to 70. To generate the activity score erythema is scored on a scale of 0 (absent) to 3 (dark red; purple/violaceous/crusted/hemorrhagic) and scale/hypertrophy are scored on a scale of 0 (absent) to 2 (verrucous/hypertrophic). Both the erythema and scale/hypertrophy scores are assessed in 13 different anatomical locations. In addition, the presence of mucous membrane lesions is scored on a scale of 0 (absent) to 1 (lesion or ulceration), the occurrence of recent hair loss is captured (1=yes; 0=no) and nonscarring alopecia is scored on a scale of 0 (absent) to 3 (focal or patchy in more than one quadrant). To calculate the CLASI activity score, all scores for erythema, scale/hypertrophy, mucous membrane lesions and alopecia are added together. Composite scores are calculated by summing the individual component scores. The higher the score, the greater the cutaneous disease activity.|Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.|The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.|||Percent Change||Standard Deviation|Mean
2598555|NCT02185040|Secondary|Change From Baseline in Tender Joint Count During the ATEP by Time Point|Joint tenderness was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count.|Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.|The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.|||Joints||Standard Deviation|Mean
2598556|NCT02185040|Secondary|Change From Baseline in Swollen Joint Count During the ATEP by Time Point|Joint swelling was noted as present or absent. Forty-four joints were assessed for swelling, including the sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), knee, ankle, and metatarsophalangeal (MTP) joints were included in this joint count.|Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.|The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.|||Joints||Standard Deviation|Mean
2598557|NCT02185040|Secondary|Change From Baseline in the Hybrid Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) During the ATEP by Time Point|The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity.|Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.|The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.|||Units on a Scale||Standard Deviation|Mean
2598558|NCT02185040|Secondary|Percentage of Participants Who Achieved ≥4 Points Reduction From Baseline in Hybrid Safety of Estrogens in Systemic Lupus Erythematosus National Assessment SLE Disease Activity Index Score (SELENA SLEDAI) During the ATEP by Time Point|The SELENA SLEDAI score measures SLE disease activity through assessment of 24 lupus descriptors/manifestations. Each descriptor (clinical or lab values) receives a positive score if it is present over the previous assessment period; a score of '0' indicates inactive disease while a positive score (from 1 to 8 based on the relative importance of each descriptor in the total scoring) indicates disease activity. The SELENA SLEDAI score is the sum of all 24 descriptors' scores for the assessment period. The SELENA SLEDAI score can range from '0' (no SLE disease activity) to a maximum theoretical score of 105 (maximum SLE disease activity). The higher the SELENA SLEDAI score the greater of SLE disease activity.|Baseline to Weeks 1, 4, 12, 24, 36, 48, 60, 72, 84, 96 and follow-up at Week 100 during the ATEP.|The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP. The number analyzed at each time point includes participants with a baseline value >= 4 and non-missing post-baseline value.|||Percentage of Participants|||Number
2598559|NCT02185040|Secondary|Terminal Phase Half-Life (T1/2) Of Iberdomide|Terminal phase half-life in plasma, calculated as [(In 2)/λz]. T1/2 half was only calculated when a reliable estimate for λz could be obtained. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.|Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.|The Pharmacokinetic population included all participants in the safety population with at least one non-missing plasma concentration datum available.|||days||Geometric Coefficient of Variation|Geometric Mean
2598560|NCT02185040|Secondary|Time to Reach Maximum Concentration (Tmax) of Iberdomide|Time to Cmax, obtained directly from the observed concentration versus time data. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.|Pharmacokinetic blood samples were collected on Day 1 and Day 29 at pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.|The PK population included all participants in the safety population with at least one non-missing plasma concentration datum available.|||days||Full Range|Median
2598586|NCT02184611|Secondary|Number of Participants With Adverse Events (AE) and Serious AE (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or is associated with liver injury and impaired liver function.|Up to Day 178|mITT Population|||Participants|||Count of Participants
2598562|NCT02185040|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUCt) of Iberdomide|The area under the plasma concentration time curve (AUCt) was defined as area under the concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. Single and multiple-dose PK were collected in Part 1 of the study for all dose groups. Iberdomide reaches steady state within 7 days. PK collection on Day 29 was sufficient to understand PK once steady state was reached. As no dose adjustments were made in ATEP, further PK collection was not needed.|Pharmacokinetic (PK) blood samples were collected on Day 1 and Day 29 pre-dose (Time = 0 hours) and at 1, 2, 3, 4, between 6 and 8 hours and 24 hours after administration of IP.|The PK population included all participants in the safety population with at least one non-missing plasma concentration datum available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2598563|NCT02185040|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) in the Active Treatment Extension Phase|A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP through 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.|From the date of the first dose of IP in the ATEP until 28 days after the last dose in the ATEP or study discontinuation; median duration of IP was 95.86 weeks for the 0.3 mg iberdomide QD cohort and 60.64 weeks for the 0.6 mg/0.3 mg ALT QD cohorts.|The active treatment extension population included all participants who were enrolled into the ATEP and received at least 1 dose of IP.|||Participants|||Count of Participants
2598564|NCT02185040|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) in Part 1 Treatment Phase|A TEAE was defined as any adverse event (AE) that began or worsened on or after the start of IP up to 28 days after the last dose of IP or IP discontinuation date, whichever was later. Each participant was counted once for each applicable category. An IP-related TEAE was defined as a TEAE that the investigator considered to be of suspected relationship to IP. The severity of each adverse event and serious AE (SAE) was assessed by the investigator and graded based on a scale from mild - mild symptoms to severe AEs (non-serious or serious). A serious adverse event (SAE) was any AE which: • Resulted in death • Was life-threatening • Required inpatient hospitalization or prolongation of existing hospitalization • Resulted in persistent or significant disability/incapacity • Was a congenital anomaly/birth defect • Constituted an important medical event.|From the start of the first dose of IP until 28 days after the last dose or study discontinuation in Part 1; median treatment duration = 12.0 weeks for the placebo, 0.3 mg QOD and 0.3 mg iberdomide QD arms, 11.9 weeks for the 0.6/0.3 ALT and 0.6 cohorts.|The safety population included all participants who were randomized and received at least 1 dose of IP. For all participants, this was the treatment group to which they were randomized.|||Participants|||Count of Participants
2598565|NCT02185014|Primary|Percentage of Participants With Endoscopic Improvement at Week 40 in Participants With Endoscopic Improvement at Week 0|Endoscopic improvement defined as a simple endoscopic score for Crohn's Disease (SES-CD) score of ≤4 and at least a 2-point reduction compared with Study M14-115 (NCT02185014) Baseline and no subscore greater than 1 in any individual endoscopic variable. The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The Total Score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Nonresponder imputation (NRI) was used for missing data.|Week 40|All enrolled participants who had endoscopic improvement at Week 0 in Study M14-347 (end of lead-in Study M14-115 [NCT02185014])|||percentage of participants||95% Confidence Interval|Number
2598566|NCT02184988|Other Pre-specified|Percentage of Subjects With an Improvement of 1 Point or More (i.e., ≥1 Point Responders) at Rest on Day 365, by Investigator Assessment on the Glabellar Line Scale (GLS)|GLS is scored: 0=none, 1=mild, 2=moderate, 3=severe. A 1-point decrease in GLS score is equivalent to a 1-point improvement on the GLS; as such, both meet the definition of a 1-point responder on the GLS|365 Days|323 subjects had a GLS score at rest >0 (i.e., 1, 2 or 3) at baseline and therefore could potentially have had a ≥1 point improvement in GLS score at rest at a post-baseline visit; 32 were missing the EOS GLS assessment|||percentage of responders||95% Confidence Interval|Number
2598567|NCT02184988|Primary|The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year|The primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365.|365 Days||||Participants|||Count of Participants
2598568|NCT02184624|Secondary|Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire|After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from ease of use questionnaire. Ease of use questionnaire consisted of six questions each for ELLIPTA inhaler and the other inhaler under study. Each question had one response to choose from 5 options of ease of use (Very easy, easy, neutral, difficult and very difficult). Based upon the response given by the participants the number of participants who rated ease of use higher for ELLIPTA, higher for non- ELLIPTA, or rated the same were reported|Day 1|Modified Intent-to-Treat Population.|||Percentage of participants|||Number
2598598|NCT02184572|Secondary|Number of Subjects With Any Solicited Local Adverse Events (AEs)|Assessed solicited local AEs were injection site pain, redness and swelling. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
2598569|NCT02184624|Secondary|Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire|After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from preference questionnaire. Preference questionnaire consisted of eight questions related to both inhalers used during the study. Each question had one response to choose from 3 preference options (Other inhaler device, ELLIPTA inhaler device and No preference). The number of participants who overall preferred the ELLIPTA device compared to non-ELLIPTA inhalers (First question in the preference questionnaire) were reported.|Day 1|Modified Intent-to-Treat population. Only participants who completed the questionnaire were included in the analysis.|||Percentage of participants|||Number
2598570|NCT02184624|Secondary|Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique|If the participant made any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participant was then asked to demonstrate inhaler use again. Any errors made by the participant were recorded by the HCP. The same procedure was repeated if the participant continues to make errors in the use of the inhaler. In total, the HCP demonstrated the use of the inhaler up to three times. Same procedure was followed for second inhaler. The number of participants who demonstrated the adequate inhalation technique after third time instructions from HCP was reported.|Day 1|Modified Intent-to-Treat Population|||Participants|||Number
2598571|NCT02184624|Secondary|Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP|An overall error includes a critical and non-critical error. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further error was made by the participant was recorded by HCP.|Day 1|Modified Intent-to-Treat Population.|||Percentage of participants|||Number
2598572|NCT02184624|Secondary|Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP|A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further critical error were made by the participant, the error were recorded by HCP.|Day 1|Modified Intent-to-Treat Population|||Percentage of participants|||Number
2598573|NCT02184624|Secondary|Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet|An overall error includes a critical and non-critical error. Any error made by the participants while demonstrating the use of the inhaler after reading the patient instruction leaflet was recorded by health care professional (HCP). The percentage of participants who made at least one overall error was reported. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1.|Day 1|Modified Intent-to-Treat Population.|||Percentage of participants|||Number
2598574|NCT02184624|Primary|Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet|A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. The percentage of participants who made at least one critical error was reported for each inhaler regardless sequence.|Day 1|Modified Intent-to-Treat Population comprised of all participants in the Intent-to-Treat Population who completed demonstration of using both study inhaler devices after reading patient information leaflet.|||Percentage of participants|||Number
2598575|NCT02184611|Secondary|Number of Days Requiring Admission to Intensive Care Unit and General Ward|The total number of days requiring admission to intensive care unit and general ward have been presented.|Up to Day 169 (Visit 9)|mITT Population|||Days|||Number
2598576|NCT02184611|Secondary|Number of Participants With Healthcare Resource Utilization Status|The total number of participants with visits for each type of healthcare contact ( office/practice visits, urgent care/outpatient clinic visits, emergency room visits and the intensive care visit and general wards visit have been presented.|Up to Day 169 (Visit 9)|mITT Population|||Participants|||Count of Participants
2598577|NCT02184611|Secondary|Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Score at Days 28, 84 and 168|The CAT is an 8-item, participant-completed instrument that covers symptoms such as cough, phlegm, chest tightness and breathlessness, and disease impacts including physical activity, confidence, sleep and energy. The CAT asks participant to score each item according to their current experience; there is no specific recall period. Items are scored on a 6-point response scale, with a score of 0 representing the participants are not experiencing the symptom/impact at all and a score of 5 representing a maximal symptom or impact. All items have equal weighting and so the total score is simply the sum of all scores and can range from 0 to a maximum of 40, with higher scores indicating a worse health state while a decrease in score indicates an improvement in health status. Baseline was the most recent recorded value before dosing on Day 1 at schedule visit. Change from Baseline was calculated by subtracting the value on-treatment from the Baseline value.|Baseline (Day 1) and Days 28, 84 and 168|mITT Population. Only those participants available at the specified time points were analyzed (represented by n=x, x in the category titles).|||Scores on a scale||Standard Error|Least Squares Mean
2598653|NCT02183792|Other Pre-specified|Total Urine Output||Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days|||||||
2598578|NCT02184611|Secondary|Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Days 28, 84 and 168|The SGRQ is designed to measure health-related quality of life (HRQoL) in participants with diseases of airway obstruction with the use of 76 items grouped into three domains: symptoms, activity and impact. The questions are designed to be self-completed by the participant based on recall of the past 4 weeks. Domain score =sum of the weighted scores for the non-missing items within each domain/maximum possible score for those non-missing items x 100. The SGRQ total score= sum of the weighted scores from all 76 items /maximum possible score for the SGRQ x100. Scores range from 0, representing the best possible health status, to 100, representing the worst possible health status. A decrease in score indicates an improvement in HRQoL whereas increase indicates deterioration in HRQoL. Baseline was the most recent recorded value before dosing on Day 1 at schedule visit. Change from Baseline was calculated by subtracting the value on-treatment from the Baseline value.|Baseline (Day 1) and Day 28, Day 84 and Day 168|mITT Population. Only those participants available at the specified time points were analyzed (represented by n=x,x in the category titles).|||Scores on a scale||Standard Error|Least Squares Mean
2598579|NCT02184611|Secondary|Mean Urine Potential of Hydrogen (pH)|Urinary pH measurement is a routine part of urinalysis. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 to 6.0). Urine samples were collected for the measurement of urine pH up to Day 168 (Visit 8). Only categories with significant values have been presented. Only those participants with data available at the indicated time point were analyzed.|Day 168 (Visit 8)|mITT Population|||pH||Standard Deviation|Mean
2598580|NCT02184611|Secondary|Number of Participants With Abnormal Urinalysis Parameters by Dipstick Method|Urinalysis parameters assessed were urine ketones, urine bilirubin, urine glucose, urine leukocyte esterase test for detecting WBC and urine protein. In this dipstick test, the level of bilirubin, glucose, leukocyte esterase and protein in urine samples was recorded as negative, trace, 1+, 2+, and 3+ (the plus sign increases with a higher level of bilirubin, glucose, leukocyte esterase, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive). Urine samples were collected for the measurement of urinalysis parameters by dipstick method up to Day 168 (Visit 8). Only categories with significant values have been presented. Only those participants with data available at the indicated time point were analyzed.|Up to Day 168 (Visit 8)|mITT Population|||Participants|||Count of Participants
2598581|NCT02184611|Secondary|Number of Participants With Clinical Chemistry Data Outside the Normal Range at Any Time Post-Baseline|Clinical chemistry parameters assessed included albumin (normal range 32 to 50 grams/Liter [G/L]), alkaline phosphatase (20 to 125 international units/Liter [IU/L]), alanine aminotransferase [ALT] (0 to 48 IU/L), aspartate aminotransferase [AST] (0 to 55 IU/L), direct bilirubin (0 to 6 micromoles/liter [umol/l]), indirect bilirubin (0 to 22 umol/l), total bilirubin (0 to 22 umol/l), calcium (2.12 to 2.56 milimoles/liter [mmol/l]), chloride (95 to 108 mmol/l), carbon dioxide [CO2] content/bicarbonate (20 to 32 mmol/l), creatinine (67.2 to 129.1 umol/l), creatinine phosphokinase [CPK] (0 to 235 IU/L), gamma glutamyl transferase [GGT] (0 to75 IU/L), glucose (3.9 to 6.9 mmol/l), phosphorus (0.7 to 1.4 mmol/l), potassium (3.5 to 5.3 mmol/l), protein total (58 to 81 G/L), sodium (135 to 146 mmol/l), urea nitrogen (2.5 to 10.5 mmol/l), uric acid (240 to 510 umol/l). Only categories with non-zero (high and low) values at any time post Baseline have been presented.|Up to Day 168 (Visit 8)|mITT Population. Only those participants with data available at the indicated time point were analyzed.|||Participants|||Count of Participants
2598582|NCT02184611|Secondary|Number of Participants With Hematology Data Outside the Normal Range at Any Time Post-Baseline|Hematology parameters included basophils (normal range 0 to 0.2 giga cells/Liter), eosinophils (0.05 to 0.55 giga cells/Liter), hematocrit (0.36 to 0.49 percentage of red blood cells in blood), hemoglobin (118 to 168 gram/Liter), lymphocytes (0.85 to 4.1 giga cells/Liter), monocytes (0.2 to 1.1 giga cells/Liter), platelet count (PC)(130 to 400 giga cells/Liter), neutrophils (1.8 to 8 giga cells/Liter), total neutrophils (TN) (1.8 to 8 giga cells/Liter), white blood cell [WBC] count (3.8 to 10.8 giga cells/Liter). Only categories with non-zero (high and low) values at any time post Baseline have been presented.|Up to Day 168 (Visit 8)|mITT Population. Only those participants available at the specified time point were analyzed represented by n=x, x in the category titles.|||Participants|||Count of Participants
2598583|NCT02184611|Secondary|Number of Participants With Electrocardiogram (ECG) Abnormalities Any Time Post Baseline|A 12-lead ECG measurement was obtained after measurement of vital signs and before spirometry testing. Participants should be placed in the supine position for the ECG measurements. Any ECG abnormality recorded by a participant after the start of study treatment was included in the any-time post-Baseline record of all ECG abnormalities. Partcipants with abnormal ECG interpretation have been presented.|Up to Day 169 (Visit 9)|mITT Population|||Participants|||Count of Participants
2598584|NCT02184611|Secondary|Change From Baseline in Vital Sign Parameter: Pulse Rate|Vital sign pulse rate was obtained after participants had rested for approximately 5 minutes and before performing electrocardiogram (ECG) and spirometry testing. A single set of values was obtained. Baseline was the most recent recorded value before dosing on Day 1 at schedule visit. Change from Baseline was calculated by subtracting the value on-treatment from the Baseline value. Anytime post-Baseline values have been presented for pulse rate.|Baseline (Day 1) to Day 169 (Visit 9)|mITT Population|||Beats/minute||Standard Deviation|Mean
2598585|NCT02184611|Secondary|Change From Baseline in Vital Sign Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital signs (SBP and DBP) were obtained after participants had rested for approximately 5 minutes and before performing electrocardiogram (ECG) and spirometry testing. A single set of values was obtained. Baseline was the most recent recorded value before dosing on Day 1 at schedule visit. Change from Baseline was calculated by subtracting the value on-treatment from the Baseline value. Anytime post-Baseline values have been presented for SBP and DBP respectively.|Baseline (Day 1) to Day 169 (Visit 9)|mITT Population|||Millimeters of mercury||Standard Deviation|Mean
2598599|NCT02184572|Secondary|Anti-rubella Virus Antibody Concentrations|Antibody concentrations were expressed as GMCs in IU/mL. Analyses included initially seronegative subjects only.|At Day 42 post vaccination|ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.|||IU/mL||95% Confidence Interval|Geometric Mean
2598587|NCT02184611|Secondary|Change From Baseline in Weighted Mean FEV1 Over 0 to 6 Hours Post-dose on Day 1|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Weighted mean FEV1 was calculated over the nominal 0 to 6 hour post dose period. Values from post-dose assessments which were actually before the time of dosing were excluded from the calculation. The 0 hour value is the average value obtained 30 minutes and 5 minutes pre-dose, and both the 0 hour and 6 hour values must be present for a 0- to 6 hour weighted mean to be calculated. The 0 -to 6 hour weighted mean was derived by calculating the area under the FEV1 curve over the nominal time points of 0 hour, 15 and 30 minutes, 1, 3 and 6 hours, using the trapezoidal rule, and then dividing by the actual time between dosing and the 6 hour assessment. Baseline value for FEV1 was calculated from the values measured 30 minutes and 5 minutes pre-dose on Day 1. Change from Baseline was calculated by subtracting the value on-treatment from the Baseline value.|Baseline (pre-dose on Day 1) and Day 1 (0 to 6 hours)|mITT Population. Only those participants with data available at the indicated time point were analyzed.|||Liters||Standard Error|Least Squares Mean
2598588|NCT02184611|Secondary|Transition Dyspnea Index (TDI) Focal Score at Week 24 (Day 168)|The Baseline Dyspnea Index (BDI) is used to measure the severity of dyspnea in participants at Baseline . The TDI measures changes in dyspnea severity from Baseline, as established by the BDI. TDI is formed of 3 individual scales that assess change in functional impairment, change in magnitude of task and change in magnitude of effort. The instrument is scored on a 7-point scale from -3 (major deterioration) to +3 (major improvement) for each category. Total scores (3 categories) range from -9 to +9 with lower scores indicating more deterioration in the severity of dyspnoea. A change of >=1 units is considered to be the minimum clinically important difference (MCID) for the TDI.|Week 24 (Day 168)|mITT Population. Only those participants with data available at the indicated time point were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2598589|NCT02184611|Primary|Change From Baseline in Trough (Pre-bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) on Treatment Day 169|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 169 was defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Treatment Day 168 (i.e. at Week 24). Baseline FEV1 is defined as the mean of the two assessments made pre-dose at Visit 2 (Day 1). Change from Baseline was calculated by subtracting the value on-treatment from the Baseline value. Modified intent-to-treat (mITT) Population comprised of all participants randomized to treatment who received at least one dose of the study medication in the treatment period.|Baseline (Day 1) and Day 169|mITT Population. Only those participants with data available at the indicated time point were analyzed.|||Liters||Standard Error|Least Squares Mean
2598590|NCT02184572|Secondary|Number of Subjects Reporting Measles-like Illness|"Measles-like illness was defined as the occurrence of the following signs/symptoms in the absence of another confirmed diagnosis:~maculopapular rash (includes measles/rubella-like rash), fever (≥ 38°C) and at least one of the symptoms: cough, coryza (runny nose), conjunctivitis or diarrhea, with fever or rash. Other event must be one of cough, coryza, conjunctivitis, or diarrhea."|During Day 5 to Day 12 post-vaccination period|Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
2598591|NCT02184572|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAE included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.|Day 0 through the end of the study (Day 180)|Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
2598592|NCT02184572|Secondary|Number of Subjects Reporting AEs of Specific Interest|AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.|Day 0 through the end of the study (Day 180)|Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
2598593|NCT02184572|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited AE included any AE reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
2598594|NCT02184572|Secondary|Number of Subjects Reporting MMR Specific Solicited General AEs|Assessed MMR specific solicited general AEs were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
2598595|NCT02184572|Secondary|Number of Subjects Reporting Any Rash|Any rash = Occurrence of AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
2598596|NCT02184572|Secondary|Number of Subjects Reporting Any Fever|Any fever (≥ 38°C) = Occurrence of fever regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
2598597|NCT02184572|Secondary|Number of Subjects With Any Solicited General AEs|Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.|During the 15-day (Days 0-14) post-vaccination period|Analysis was performed on TVC which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
2598600|NCT02184572|Secondary|Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Unit per milliliter [IU/mL] (ELISA, Enzygnost) among subjects who were seronegative (antibody concentration < 4 IU/mL) before vaccination.|At Day 42 post vaccination|ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.|||Percentage of subjects||95% Confidence Interval|Number
2598601|NCT02184572|Secondary|Anti-mumps Virus Antibody Concentrations|Antibody concentrations were expressed as GMCs in EU/mL. Analyses included initially seronegative subjects only.|At Day 42 post vaccination|According to Protocol (ATP) cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps, or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.|||EU/mL||95% Confidence Interval|Geometric Mean
2598602|NCT02184572|Secondary|Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Unit per milliliter [EU/mL] (ELISA, Pharmaceutical Product Development, Inc.[PPD]) among subjects who were seronegative (antibody concentration < 5 EU/mL) before vaccination.|At Day 42 post vaccination|ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.|||Percentage of subjects||95% Confidence Interval|Number
2598603|NCT02184572|Secondary|Anti-measles Virus Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analyses included initially seronegative subjects only.|At Day 42 post vaccination|ATP cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.|||mIU/mL||95% Confidence Interval|Geometric Mean
2598604|NCT02184572|Secondary|Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-measles virus antibody concentration greater than or equal to [≥] 200 milli International Units per milliliter [mIU/mL] (Enzyme-Linked Immunosorbent Assay [ELISA], Enzygnost) among subjects who were seronegative (antibody concentration less than [<] 150 mIU/mL) before vaccination.|At Day 42 post vaccination|According to Protocol (ATP) cohort for immunogenicity: included all eligible subjects with pre and post-vaccination serology results available for at least one vaccine components of measles, mumps or rubella, who did not meet any elimination criteria up to the Visit 2 blood sample and who complied with the post dose blood sample schedule.|||Percentage of subjects||95% Confidence Interval|Number
2598605|NCT02184572|Primary|Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination|Fever was assessed for temperature equal to/above (≥) 38.0°C and above (>) 39.0°C. The safety profile for fever was assessed based on the group difference (INV_MMR minus COM_MMR) in incidence of fever equal to or below the cut-off value.|During Day 5 to Day 12 post-vaccination period|Analysis was performed on Total Vaccinated cohort (TVC) which included all vaccinated subjects with administration of either Priorix or M-M-R II/M-M-R VaxPro lots documented.|||Participants|||Count of Participants
2598606|NCT02184494|Other Pre-specified|Fatigue/Depression Assessment|"Fatigue Severity Scale: 9-item, self-reporting rating that rates the severity of your fatigue symptoms on a Likert scale ranging from 1 to 7, with 1 indicating strong disagreement, and 7 indicating strong agreement. The sum of scores is calculated. The lower the score, the more severe the participant's fatigue symptoms.~Beck's Depression Inventory: 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression on a Likert scale ranging from 0 to 3, with 3 being the most severe. The sum of scores is calculated. A high score indicates more severe depression and related symptoms."|Collected at the same time as the other questionnaires. Lasted approximately 5-7 minutes.|2 of the 8 healthy, older adults did not complete all of the surveys, and were thus unable to be added to analysis.|||units on a scale||Standard Deviation|Mean
2598607|NCT02184494|Other Pre-specified|Health and Activity Questionnaire|"Short Form 36 Health Survey questionnaire: patient-reported survey of 36 questions, yielding the participant's degree of health on 8 different scale scores (each scale summed into a 0-100 score, with lower scores indicating more disability). The eight scales include vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health.~Schwab and England Activities of Daily Living Questionnaire: self-rated, single item assessment of the participant's ability to perform daily activities with speed and independence, measured using a Likert scale of percentages, in 10% increments. A score of 100% indicates total independence, while 0% indicates complete dependence."|Collected immediately after the UPDRS (if PD population), or immediately after the resting energy expenditure measurement (if MS or healthy, older adult). Measured with other questionnaires and immediately before squatting exercise. Lasted ~10 minutes.|2 of the 8 healthy, older adults did not complete all of the surveys, and were thus, clearly unable to be added to analysis.|||units on a scale||Standard Deviation|Mean
2598623|NCT02184195|Secondary|Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire|"To assess the effect of olaparib on health-related quality of life (QoL) as measured by the EORTC-QLQ-C30 global QoL scale. The EORTC-QLQ-C30 is defined as EORTC QLQ-C30: a questionnaire (30 questions) used to evaluate disease symptoms, functional impacts (eg, physical functioning), and HRQoL and to characterize clinical benefit from the patient perspective. The HRQoL score ranges from 0 to 100.~A higher score indicates better QoL. A score change of 10 points was pre-defined as clinically meaningful.~bd twice daily."|From baseline up to 6 months|Patient reported outcome (PRO) analysis set was defined as the analysis population for PRO data were a subset of the FAS (ITT) population who had evaluable baseline EORTC QLQ-C30 or QLQ-PAN26 forms where evaluable meant that at least 1 sub-scale baseline score could be determined from at least 1 of the 2 forms.|||Unit on scale||95% Confidence Interval|Mean
2598608|NCT02184494|Other Pre-specified|Neurological Function|Neurological functional state will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). Of the 5 sections of the examination, two parts were used. Part II (self-evaluation of aspects of the experiences of daily living) consisted of 13 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, saliva and drooling, chewing and swallowing, eating tasks, dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed/car/deep chair, walking and balance, and freezing. Part III (motor evaluation performed by trained research personnel) consisted of 14 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, facial expression, rigidity, finger tapping, hand movements, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, etc... Values were summed, with higher values indicating increased impairment and disability.|Measured immediately after the resting energy expenditure measurement, and before the other questionnaires. Lasted approximately 15 minutes.|The MS and healthy, older adults populations were not required to be assessed with the UPDRS because the assessment materials were for PD populations, specifically.|||units on a scale||Standard Deviation|Mean
2598609|NCT02184494|Secondary|Resting Energy Expenditure|Measured using using indirect calorimetry with a ventilated face mask and noseclip (Parvometrics, Sandy, UT). This involves laying supine for 30 to 60 minutes.|Measured immediately upon arriving to the laboratory. Lasted approximately 25 minutes.|"1 of the 12 PD participants had severe claustrophobia, and could not tolerate the breathing mask on their face.~1 of the 12 PD participants, and 1 of the 8 healthy, older adults participants: dysfunctional equipment, and thus invalid results."|||kcal||Standard Deviation|Mean
2598610|NCT02184494|Primary|Blood Lactate Response|Measured using a blood lactate analyzer, a finger prick test measured before, after, and 10 minutes after exercise|Before, immediately after, and 10 minutes after the squatting exercise protocol|"2 of the 8 participants in the healthy, older adults group did not return for this visit, and thus, were not included in analysis.~1 of the 12 MS participants did not return for this visit, and thus, were not included in analysis."|||mmol/L||Standard Deviation|Mean
2598611|NCT02184455|Secondary|Percent Change in Wound Area From Baseline|change in area of wound in percent from initial presentation|12 Weeks||||percentage of change from baseline||Standard Error|Mean
2598612|NCT02184455|Secondary|Percent Change in Wound Size Compared to Baseline|Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100. Note 100% equals complete closure of the wound.|20 weeks||||percentage from baseline||Standard Error|Mean
2598613|NCT02184455|Secondary|Number of Patients With Ulcer Reoccurrence in the Same Location After Complete Healing|Number of patients that reported a reoccurrence of the ulcer in the same location after complete healing at 1 year post treatment.|1 year|These are the number of patients that had their ulcer healed within the 20 weeks of the study.|||participants|||Number
2598614|NCT02184455|Secondary|Number of Patients With Adverse Events|Reporting the number of patients participating in the study having adverse events|20 weeks||||Participants|||Count of Participants
2598615|NCT02184455|Secondary|Percentage of Patients With Complete Healing at Any Time Point|Complete healing is defined as 100% epithelialization without drainage. Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100.|20 weeks||||Participants|||Count of Participants
2598616|NCT02184455|Primary|Percentage of Wound Area Reduction Compared to Baseline|Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100.|4 weeks||||percentage of wound closure||Standard Error|Mean
2598617|NCT02184442|Secondary|Effective Orifice Area - Change From Baseline||1 Year|Valve Implant Population; Please note that echo data was not available for all patients.|||cm^2||Standard Deviation|Mean
2598618|NCT02184442|Secondary|Total Aortic Regurgitation - Change From Baseline|"Total aortic regurgitation was assessed by the core lab as 'Grade 0' = None, 'Grade 1+' = Trace, 'Grade 2+' = Mild, 'Grade 3+' = Moderate, and 'Grade 4+' = Severe.~Total regurgitation at one year was analyzed in the valve implant population."|1 Year|Please note that all the valve-implant population do not have echo data.|||Grade||Standard Deviation|Mean
2598619|NCT02184442|Secondary|NYHA Classification - Change From Baseline|New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.|Baseline and 1 Year|Please note that all the patients were not available for a NYHA functional assessment|||Units on a scale||Standard Deviation|Mean
2598620|NCT02184442|Primary|Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization|All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year|1 Year||||participants|||Number
2598621|NCT02184208|Primary|Successful Extubation|Successful extubation without the use of noninvasive ventilation or requiring reintubation|Within 24 hours of extubation||||Participants|||Count of Participants
2598622|NCT02184195|Secondary|Number of Participants With Adverse Events (AEs)|To assess the safety and tolerability of olaparib maintenance monotherapy. SAE: serious adverse events CTCAE: Common Terminology Criteria for Adverse Events|Up to 4 years||||Participants|||Number
2598624|NCT02184195|Secondary|Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1|Efficacy by assessment of disease control rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo.|At 16 weeks|Intention to treat (ITT): All randomised patients|||Participants|||Number
2598625|NCT02184195|Secondary|Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1|To determine efficacy by assessment of objective response rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo. The ORR is defined as the number of with a BoR of CR and PR according to the BICR data divided by the number of patients in the treatment group with measurable disease at baseline.|Up to 4 years|All randomised patients with measurable disease at baseline.|||Participants|||Count of Participants
2598626|NCT02184195|Secondary|Time From Randomisation to Study Treatment Discontinuation or Death (TDT)|To determine the efficacy by assessment of TDT compared to placebo. compared to placebo. The TDT was defined as time to study treatment discontinuation or death.|Up to 4 years|Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.|||Months||95% Confidence Interval|Median
2598627|NCT02184195|Secondary|Time From Randomisation to First Subsequent Therapy or Death (TFST)|To determine the efficacy by assessment of TFST of olaparib maintenance monotherapy compared to placebo. The TFST was defined as time to first subsequent therapy or death.|Up to 4 years|Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.|||Months||95% Confidence Interval|Median
2598628|NCT02184195|Secondary|Time From Randomisation to Second Subsequent Therapy or Death (TSST)|To determine the efficacy by assessment of TSST of olaparib maintenance monotherapy compared to placebo. The TSST was defined as time to second subsequent therapy or death.|Up to 4 years|Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.|||Months||95% Confidence Interval|Median
2598629|NCT02184195|Secondary|Time From Randomisation to Second Progression (PFS2)|To determine efficacy by assessment of PFS2 of olaparib maintenance monotherapy compared to placebo. The PFS2 was defined as the time from the date of randomisation to the earliest of the progression event subsequent to that used for the primary variable PFS or death.|Up to 4 years|Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.|||Months||95% Confidence Interval|Median
2598630|NCT02184195|Secondary|Overall Survival (OS)|To determine the efficacy by assessment of OS of olaparib maintenance monotherapy compared to placebo. The OS was defined as the time from the date of randomization until death due to any cause.|Upto 4 years|Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.|||Months||95% Confidence Interval|Median
2598631|NCT02184195|Primary|Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1)|To determine the efficacy of olaparib maintenance monotherapy compared to placebo by PFS. The PFS was defined as the time from randomisation until the date of objective radiological disease progression according to modified RECIST v1.1 or death (by any cause in the absence of disease progression) regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to disease progression.|Up to 4 years|Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.|||Months||95% Confidence Interval|Median
2598632|NCT02184143|Secondary|Physical Activity|Physical activity measured by a commercially available movement accelerometer|Up to 12 months after spine surgery|Number analyzed indicate the number of participants who completed the measure at each time point.|||Mean Activity Counts/Minute||95% Confidence Interval|Mean
2598633|NCT02184143|Primary|12-Item Short Form Health Survey (SF-12)|The SF-12 is a measure of general physical and mental health. The SF-12 is scored from 0 to 100, with higher scores indicating better health.|Up to 12 months after spine surgery|Number analyzed indicate the number of participants who completed the measure at each time point.|||units on a scale||95% Confidence Interval|Mean
2598634|NCT02184143|Primary|Brief Pain Inventory (BPI)|The BPI measures pain from 0 to 10, with higher scores indicating a worse outcome|Up to 12 months after spine surgery|Number analyzed indicate the number of participants who completed the measure at each time point.|||units on a scale||95% Confidence Interval|Mean
2598635|NCT02184143|Primary|Oswestry Disability Index (ODI)|The ODI measures disease-specific disability on a scale from 0 to 100, with higher scores indicating worse disability.|Up to 12 months.|Number analyzed indicate the number of participants who completed the measure at each time point.|||units on a scale||95% Confidence Interval|Mean
2598636|NCT02183792|Other Pre-specified|Hospital Length of Stay||Participants will be followed for the duration of hospital stay, an expected average of 5 days|||||||
2598637|NCT02183792|Other Pre-specified|Change in Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL)||At baseline, 24, 48, 72 and 96 hours post randomization|||||||
2598638|NCT02183792|Other Pre-specified|Change in Cystatin C||At baseline, 24 and 96 hours post randomization|||||||
2598639|NCT02183792|Other Pre-specified|Change in N-terminal Pro-B-type Natriuretic Peptide||At baseline, 24 and 96 hours post randomization|||||||
2598640|NCT02183792|Other Pre-specified|Change in Copeptin||At baseline, 24 and 96 hours post randomization|||||||
2598641|NCT02183792|Other Pre-specified|Change in Plasma Renin Activity||At baseline, 24 and 96 hours post randomization|||||||
2598642|NCT02183792|Other Pre-specified|Symptomatic Hypotension||Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days|||||||
2598643|NCT02183792|Other Pre-specified|Incidence of Electrolyte Abnormalities|Hypo- and hyperkalemia defined as outside the range of 3.5 to 5.0 mEq/L Hypo- and hypermagnesemia defined as outside the range of 1.5-2.4 mEq/L|Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days|||||||
2598644|NCT02183792|Other Pre-specified|Acute Worsening of Kidney Function (Defined as an Increase in Serum Creatinine 0.3 mg/dL or 25% Above Baseline)||Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days|||||||
2598645|NCT02183792|Other Pre-specified|Change in Self-rated Dyspnea||At baseline, 24 and 96 hours post randomization|||||||
2598646|NCT02183792|Other Pre-specified|Cumulative Metolazone Use||Up to 96 hours post randomization and participants will be followed for the duration of hospital stay, an expected average of 5 days|||||||
2598656|NCT02183675|Primary|Area Under the Plasma Concentration Curve at Steady State for HCTZ|Area under the plasma concentration curve (AUC) of HCTZ in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2598657|NCT02183675|Primary|Maximum Measured Concentration (Cmax) at Steady State for HCTZ|Maximum measured concentration (Cmax) of HCTZ in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h and 48h after 10 days drug administration|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2598658|NCT02183675|Primary|Area Under the Plasma Concentration Curve at Steady State for Amlodipine|Area under the plasma concentration curve (AUC) of amlodipine in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2598659|NCT02183675|Primary|Maximum Measured Concentration (Cmax) at Steady State for Amlodipine|Maximum measured concentration (Cmax) of amlodipine in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h and 144h after 10 days drug administration|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2598660|NCT02183675|Secondary|Amount of HCTZ Excreted in Urine at Steady State From 0 to 24 Hours|Amount of HCTZ excreted in urine over the time interval from 0 to 24 hours at steady state|0-6 hours (h), 6-12h and 12-24h after drug administration on day 10|PK set|||mg||Geometric Coefficient of Variation|Geometric Mean
2598661|NCT02183675|Primary|Area Under the Plasma Concentration Curve at Steady State for Telmisartan|Area under the plasma concentration curve (AUC) of telmisartan in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2598662|NCT02183675|Primary|Maximum Measured Concentration (Cmax) at Steady State for Telmisartan|Maximum measured concentration (Cmax) of telmisartan in plasma at steady state over the dosing interval tau|15 minutes (min) before drug administration and 15min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h and 72h after 10 days drug administration|Pharmacokinetic (PK) set which included all subjects in the treated set who had evaluable PK variable of test (T80/A5/H12.5 mg) and at least one of two references (T80/H12.5 mg and T80/A5 mg) for treatment periods 1, 2, and 3. Subjects who had a protocol deviation relevant to the evaluation of relative bioavailability were excluded.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2598663|NCT02183519|Primary|Peak Expiratory Flow Rate|Peak expiratory flow rate is the maximum volume of air that is expelled per unit time for each cough in a cough epoch. Measured in liters/second.|1-2 hours||||Liters of air/second||Standard Deviation|Mean
2598664|NCT02182999|Secondary|Patient's Overall Satisfaction With Pain Management|Patient satisfaction with pain management was investigated on a numeric rating scale (NRS; scale 0-10) as part of routine examination 6 weeks after the procedure. Higher numbers indicate higher patients satisfaction.|6 weeks||||units on a scale||Standard Deviation|Mean
2598665|NCT02182999|Secondary|Patient's Overall Satisfaction With Surgery|Patient satisfaction with surgery was investigated on a numeric rating scale (NRS; scale 0-10) as part of routine examination 6 weeks after the procedure. Higher numbers indicate higher patients satisfaction.|6 weeks||||units on a scale||Standard Deviation|Mean
2598666|NCT02182999|Secondary|American Orthopaedic Foot and Ankle Society Score (AOFAS)|The American Orthopedic Foot and Ankle Society Score (AOFAS-Score, Forefoot Version) is comprised of nine questions and coveres three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. The scale ranges from 0 to 100, with higher values representing a better outcome.|6 weeks||||units on a scale||Standard Deviation|Mean
2598667|NCT02182999|Primary|Peak Postoperative Numeric Rating Scale (NRS) for Pain|"The primary outcome parameters of this study were average pain and peak pain level on the verbal numeric rating scale (NRS; 1-10, higher numbers indicating increasing pain level) during the first 48 hours after surgery. NRS scores for pain were assessed by members of the nursing staff every 4 hours for 48 hours after the procedure (until discharge). Patients were instructed to rate their pain level on a scale from 0 to 10, with 0 meaning no pain and 10 indicating pain as bad as it could be. Peak postoperative numeric rating scale (NRS) for pain was calculated for each group (Placebo, Ropivacaine) by adding the highest recorded NRS score for pain of all patients in each group (Placebo, Ropivacaine) to obtain the mean peak postoperative NRS score."|First 48 postoperative hours||||units on a scale||Standard Deviation|Mean
2598668|NCT02182999|Primary|Average Postoperative Numeric Rating Scale (NRS) for Pain|"The primary outcome parameters of this study were average pain and peak pain level on the verbal numeric rating scale (NRS; 1-10, higher numbers indicating increasing pain level) during the first 48 hours after surgery. NRS scores for pain were assessed by members of the nursing staff every 4 hours for 48 hours after the procedure (until discharge). Patients were instructed to rate their pain level on a scale from 0 to 10, with 0 meaning no pain and 10 indicating pain as bad as it could be. Average postoperative numeric rating scale (NRS) for pain was calculated for each group (Placebo, Ropivacaine) by adding all postoperative NRS scores of all patients in each group (Placebo, Ropivacaine) to obtain the mean postoperative NRS score."|First 48 postoperative hours||||units on a scale||Standard Deviation|Mean
2598669|NCT02182973|Secondary|Head Circumference Change at 2 Weeks|Change in head circumference from day 1 to day 14 (cm/wk)|2 weeks||||cm/wk||Standard Deviation|Mean
2598670|NCT02182973|Secondary|Weight Change at 2 Weeks|Change in weight from study day 1 to study day 14 (grams/day) Weight day 14 - weight day 1 divided by 14|2 weeks||||grams/day||Standard Deviation|Mean
2598671|NCT02182973|Primary|Percentage of Infants Achieving a GI Subscore >2 Over the Study Period|Minimum score:0; Maximum score 13. Higher scores mean more GI distress|2 weeks||||Percentage of participants|||Number
2608990|NCT02071290|Primary|Plasma IL-10|Change in plasma levels of anti-inflammatory mediator IL-10 over 24 hours from Admission|0 (Admission), 1, 3, 24 hours||||pg/mL||Inter-Quartile Range|Median
2598672|NCT02182895|Secondary|Patient Satisfaction|Diabetes Treatment Satisfaction Questionnaire - InPatient (DTSQ-IP). This questionnaire had 14 items that were scored on a scale of 0 to 6. Total score for each subjects could range from 0-84. Higher score means better satisfaction.|At the time of discharge or Day 5||||Score||Standard Deviation|Mean
2598673|NCT02182895|Secondary|Length of Hospital Stay|Number of days in hospital|Admission to discharge, an expected average of 5 days|completed|||days||Standard Deviation|Mean
2598674|NCT02182895|Secondary|Variability in Glucose Levels|Mean amplitude of glycemic excursions|Days 2 to 5|Patients who allowed a CGMS.|||mmol/L||Standard Deviation|Mean
2598675|NCT02182895|Secondary|Incidence of Hyperglycemia (Blood Glucose >200 mg/dL)|Proportion of BG readings in the severe hyperglycemic range.|Days 2 to 5|completed|||% of blood glucose readings >200|||Number
2598676|NCT02182895|Secondary|Incidence of Hypoglycemia (BG <70 mg/dL)|Number of BG readings <70 mg/dL in each group|Days 2 to 5|completed|||number of events|||Number
2598677|NCT02182895|Secondary|Dose of Insulin|Average daily amount of insulin used|Days 2 to 5|completed subjects|||Units||Standard Deviation|Mean
2598678|NCT02182895|Secondary|Percentage of Blood Glucose Readings in 70-140 mg/dL Range|Percentage of BG readings in the desired range of 70-140 mg/dl out of all avaialble BG readings.|Days 2 to 5|completed subjects|||% of blood glucose readings|||Number
2598679|NCT02182895|Primary|Mean Daily Blood Glucose Levels During Hospital|mean of average daily blood blood glucose for each patient day|Hospital days 2-5|Inpatients with diabetes|||mg/dL||Standard Deviation|Mean
2598680|NCT02182843|Secondary|Number of Participants With Radiographic Success at 24 Months|"Radiographic fusion was assessed at each operated level using the Bridwell fusion grading system:~Grade I (definite) - Fused with remodeling and trabeculae~Grade II (probable) - Graft intact, not fully remodeled and incorporated through, no lucencies~Grade III (probably not) - Graft intact, but definite lucency at the top or bottom of the graft~Grade IV (no) - Definitely not fused, with resorption of bone graft or collapse.~Radiographic success was defined as grade 1 or 2 fusion at every operated level at 24 months"|24 Months|71/81 of originally enrolled participants had radiographs available for analysis at 24 months|||Participants|||Count of Participants
2598681|NCT02182843|Primary|Change in NDI From Baseline|Neck Disability Index (NDI) is a patient-completed, condition-specific functional status questionnaire including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each of the 10 items is scored from 0 - 5, with a maximum score of 50. The obtained score is multiplied by 2 to produce a percentage score. A higher score indicates more patient-rated disability (0 points or 0% means : no activity limitations , 50 points or 100% means complete activity limitation). The minimal clinically important difference or change (MCID / MCIC) is described as the smallest difference or change that patients perceive as beneficial. In patients with cervical radiculopathy the MCID is 7 points of change ( 14%). In order to demonstrate improvement in status, the NDI would need to be reduced by at least 14%.|12 months after device implantation||||score on a scale||Standard Deviation|Mean
2598682|NCT02182830|Secondary|Change From Baseline in Trough Seated DBP (mmHg) at Week 24|"Change from baseline in trough seated DBP (mmHg) at Week 24 is secondary endpoint. The term baseline refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means."|baseline and 24 weeks|FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)|||mmHg||Standard Error|Mean
2598683|NCT02182830|Secondary|Change From Baseline in Trough Seated DBP (mmHg) at Week 12|"Change from baseline in trough seated DBP (mmHg) at Week 12 is secondary endpoint. The term baseline refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means."|baseline and 12 weeks|FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)|||mmHg||Standard Error|Mean
2598684|NCT02182830|Secondary|Change From Baseline in Trough Seated SBP (mmHg) at Week 24|"Change from baseline in trough seated SBP (mmHg) at Week 24 is secondary endpoint. The term baseline refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means."|baseline and 24 weeks|FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)|||mmHg||Standard Error|Mean
2598685|NCT02182830|Secondary|Change From Baseline in Mean 24-hour Ambulatory DBP (mmHg) at Week 24|"Change from baseline in mean 24-hour ambulatory DBP (mmHg) at Week 24 is secondary endpoint. The term baseline refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means."|baseline and 24 weeks|FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)|||mmHg||Standard Error|Mean
2598686|NCT02182830|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (DBP) at Week 12|"Change from baseline in mean 24-hour ambulatory DBP (mmHg) at Week 12. The term baseline refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means."|baseline and 12 weeks|FAS (LOCF-H)|||mmHg||Standard Error|Mean
2598687|NCT02182830|Secondary|Change From Baseline in Mean 24-hour Ambulatory SBP (mmHg) at Week 24|"Change from baseline in mean 24-hour ambulatory SBP (mmHg) at Week 24 is secondary endpoint. The term baseline refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means."|baseline and 24 weeks|FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)|||mmHg||Standard Error|Mean
2598688|NCT02182830|Secondary|Change From Baseline in Trough Seated SBP at Week 12|"Change from baseline in trough seated SBP (mmHg) at Week 12 is presented. The term baseline refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means. This is a key secondary endpoint"|baseline and 12 weeks|FAS OC-H =FAS observed cases without values following a change in antihypertensive therapy (OC-H)|||mmHg||Standard Error|Mean
2598689|NCT02182830|Secondary|Change From Baseline in Body Weight at Week 24|"Changes from baseline in body weight at Week 24 is presented. The term baseline refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means. This is a key secondary endpoint"|baseline and 24 weeks|FAS OC|||kilogram (kg)||Standard Error|Mean
2598690|NCT02182830|Secondary|Changes From Baseline in Trough Mean Ambulatory SBP at Week 12|"Changes from baseline in trough mean ambulatory SBP at Week 12 is presented. The term baseline refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means. This is a key secondary endpoint"|baseline and 12 weeks|FAS LOCF-H|||millimeter of mercury (mmHg)||Standard Error|Mean
2598691|NCT02182830|Secondary|Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (SBP) at Week 12|"Change from baseline in mean 24-hour ambulatory Systolic blood pressure SBP at Week 12 is presented. The term baseline refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means. This is a key secondary endpoint"|baseline and 12 weeks|FAS LOCF-H; LOCF-H= Last observation carried forward without values following antidiabetic rescue medication and/or a change in antihypertensive therapy|||millimeter of mercury (mmHg)||Standard Error|Mean
2598692|NCT02182830|Primary|Change From Baseline in Glycated Haemoglobin (HbA1c) (%) at 24 Weeks|"Change from baseline in HbA1c (%) at 24 weeks is presented. The term baseline refers to the last observation prior to randomisation of the patient.~Means presented are the adjusted means. Restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) model is used in the statistical analysis."|baseline and 24 weeks|"Full analysis set (FAS) observed cases (OC); FAS: All patients randomised, treated with at least one dose of trial drug, and with a baseline and at least one on-treatment HbA1c value.~Observed cases will set all values measured after antidiabetic rescue medication to missing"|||percentage of glycated haemoglobin||Standard Error|Mean
2598693|NCT02182492|Other Pre-specified|Measurement of Protein Levels of Inflammatory Molecules in Tissues||Polyp tissues from CRSwNP patients and diseased sinus mucosa from CRSsNP patients will be collected during surgery.|||||||
2598694|NCT02182492|Secondary|Total Nasal Endoscopic Scores|Nasal endoscopic evaluation was performed by the senior investigator who remained blinded to the treatment, including poly size: 0, absence of polyps; 1, polyps in middle meatus only; 2, polyps beyond middle meatus but not blocking the nose completely; and 3, polyps completely obstructing the nose; discharge: 0, no discharge; 1, clear thin discharge; 2, thick purulent discharge; edema: 0, no edema; 1, mild edema; 2, severe edema; crusting: 0, no crusting; 1, mild crusting; 2, severe crusting; scarring: 0, no scarring; 1, mild scarring; 2, severe scarring). Each side was graded separately, and the scores from both sides were added to determine the overall scores for a particular domain. The total endoscopy score was calculated based on the sum of scores of these endoscopic domains. Endoscopic scores were also recorded before ESS (baseline) and at 1-, 3-, 6- and 12-month follow-up visits. Total endoscopy score range: 0~22, with higher scores indicating greater severity.|Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit.|A total of 187 patients met the study eligibility criteria. Seven patients in fluticasone propionate group and 8 patients in clarithromycin group dropped out because of nonadherence.|||score on a scale||Standard Deviation|Mean
2598695|NCT02182492|Primary|Total Subjective Symptoms Visual Analog Scores (VAS)|"The treatment will begin one week after ESS. Symptoms visual analog scores (VAS) were recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit. All of the patients were assessed by using symptom questionnaire after enrollment and at follow-up visits. Subjective symptoms were scored by patients on a VAS of 0-10, with 0 being no complaint whatsoever and 10 being the worst imaginable complaint.Five major symptoms were focused on: nasal obstruction, rhinorrhea, loss of sense of smell, facial pain or pressure, and headache. Total VAS score was calculated based on the sum of VAS scores of these five symptom domains. Total subjective symptoms VAS range: 0~50, with higher scores indicating greater severity of symptoms."|Scores will be recorded just before ESS and at 1-, 3-, 6- and 12-month follow-up visit.|A total of 187 patients met the study eligibility criteria. Seven patients in fluticasone propionate group and 8 patients in clarithromycin group dropped out because of nonadherence.|||score on a scale||Standard Deviation|Mean
2598696|NCT02182440|Other Pre-specified|Number of Patients Who Meet at Least One of the MAKE 90 Criteria|"Make 90 includes patients who meet at least one of the following parameters at Day 90:~had eGFR <60 ml/min at Day 90, estimated by the CKD-EPI formula based on a serum creatinine or~was dialysis dependent up to Day 90 or~was hospitalized for a new episode of acute kidney injury prior to Day 90 or~died, prior to Day 90 Statistical analysis was only performed on the placebo and 1.6 mg/kg recAP arm due to the small number of patients treated with the doses of 0.4 mg/kg and 0.8 mg/kg recAP. Those two doses were dropped in part 2 of the study."|Day 90|ITT|||Participants|||Count of Participants
2598697|NCT02182440|Other Pre-specified|Number of Participants Meeting at Least One MAKE 60 Criteria|"Make 60 is composed of patients that meet at least one of the following criteria at day 60:~had eGFR < 60 mL/min (calculated by using the CKD-EPI formula) or~became dialysis dependent up to Day 60 or~died prior to Day 60 Statistical analysis was only performed on the placebo and 1.6 mg/kg recAP arm due to the small number of patients treated with the doses of 0.4 mg/kg and 0.8 mg/kg recAP. Those two doses were dropped in part 2 of the study."|Day 60||||Participants|||Count of Participants
2598698|NCT02182440|Other Pre-specified|All-cause Mortality at Day 90|Number of patients in the ITT set, who died in the period between Day 1 and Day 90 Statistical analysis was only performed on the placebo and 1.6 mg/kg recAP arm due to the small number of patients treated with the doses of 0.4 mg/kg and 0.8 mg/kg recAP. Those two doses were dropped in part 2 of the study.|Day 90|ITT|||Participants|||Count of Participants
2598699|NCT02182440|Other Pre-specified|All-cause Mortality at Day 28|Number of patients in the ITT set, who died in the period between day 1 to day 28. Statistical analysis was only performed on the placebo and 1.6 mg/kg recAP arm due to the small number of patients treated with the doses of 0.4 mg/kg and 0.8 mg/kg recAP. Those two doses were dropped in part 2 of the study.|Day 28|ITT set|||Participants|||Count of Participants
2598700|NCT02182440|Secondary|Number of Participants Who Had Renal Replacement Therapy (RRT) During the Period Day 1 to Day 28, Inclusive|During the study the days on Renal Replacement Therapy (RRT) was recorded for each patients. During the first 7 days of the study (D1 to D7 included), patients were only allowed to receive continuous RRT, thereafter patients were also allowed to receive intermittent RRT. Standardization of RRT was attempted by providing guidelines to start and stop RRT (see protocol). Statistical analysis was only performed on the placebo and 1.6 mg/kg recAP arm due to the small number of patients treated with the doses of 0.4 mg/kg and 0.8 mg/kg recAP. Those two doses were dropped in part 2 of the study.|28 days|ITT combined|||Participants|||Count of Participants
2598711|NCT02181842|Primary|Changes From Baseline in Laboratory Parameters (Low-Density Lipoprotein Cholesterol (LDL-Cholesterol)) at 48 Week|Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is LDL-Cholesterol as a one of laboratory parameters.|From Baseline, Up to 48 Week|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given populations.|||mg/dL||Standard Deviation|Mean
2598701|NCT02182440|Primary|Area Under the Time Corrected Endogenous Creatinine Clearance From Day 1 to Day 7 (AUC1-7)|"Primary endpoint is calculated as the average of the standardized endogenous creatinine clearance values over the first seven days between the placebo and 1.6 mg/kg recAP arm.~Standardized endogenous creatinine clearance is assessed on each days from D1 to Day 7 during a 6 +/- 1 hour period and calculated in mL/min as the mean creatinine clearance over the period. The study started with 4 treatment arms of which 0.4 mg/kg recAP and the 0.8 mg/kg recAP were dropped after the interim analysis. The number of the patients in the dropped arm are respectively 30 and 32. Therefore the statistical analysis has been performed only on the placebo and 1.6 mg/kg group."|7 days|ITT combined includes all patients randomized in part 1 and part 2 of the study, excluding patients recruited whilst the interim analysis is performed to treatment arms not selected for Part 2. Some values were discarded by the adjudication committee.|||mL/min||Inter-Quartile Range|Median
2598702|NCT02182115|Primary|Eradication of Staphylococcus Aureus (SA) Carriage at All 4 Body Sites Tested.|Participants with no SA post-treatment, proportion (%) of participants in each study arm that had no SA detected on the post-treatment cultures from the 4 body sites sampled with swab cultures.|Immediately prior to surgery patients are swabbed again at the 4 body sites to see if SA is present or not.||||Participants|||Count of Participants
2598703|NCT02181842|Secondary|Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)|ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Up to 48 Weeks|Safety Analysis Set; The safety analysis set was defined as all participants who were enrolled and completed the study.|||Participants|||Count of Participants
2598704|NCT02181842|Primary|Blood Glucose-Related Laboratory Parameters (HbA1c Values) at Each Time Point|HbA1c (NGSP) values at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.|Baseline and 48 Week|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given populations.|||Percent||Standard Deviation|Mean
2598705|NCT02181842|Primary|Blood Glucose-Related Laboratory Parameters (Fasting Blood Glucose Level) at Each Time Point|Fasting blood glucose level at baseline and 48 Week were reported as one of blood glucose-related laboratory parameters.|Baseline and 48 Week|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given populations.|||mg/dL||Standard Deviation|Mean
2598706|NCT02181842|Primary|Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Presence of Companion Anti-Diabetes Drugs|The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, presence of companion anti-diabetes drugs, at the time of enrollment. Presence of companion anti-diabetes drugs at the time of enrollment were categorized into Had presence of companion anti-diabetes drugs and Had no presence of companion anti-diabetes drugs.|From Baseline, Up to 48 Week|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given populations.|||Percent HbA1c||Standard Deviation|Mean
2598707|NCT02181842|Primary|Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of BMI|The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, Levels of BMI, at the time of enrollment. Levels of BMI at the time of enrollment were categorized into <18.5 kg/m^2, 18.5 to <25 kg/m^2, 25 <30 kg/m^2, and 30 kg/m^2 ≤.|From Baseline, Up to 48 Week|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given populations.|||Percent HbA1c||Standard Deviation|Mean
2598708|NCT02181842|Primary|Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Gender|The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, Gender, at the time of enrollment. Gender was categorized into male and female.|From Baseline, Up to 48 Week|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given populations.|||Percent HbA1c||Standard Deviation|Mean
2598709|NCT02181842|Primary|Changes From Baseline in HbA1c at 48 Week in Participants Stratified by Levels of HbA1c|The reported data were changes from baseline in laboratory parameter, that is HbA1c (NGSP), at 48 Week in participants stratified by specific characteristics, Levels of HbA1c, at the time of enrollment. Levels of HbA1c at the time of enrollment were categorized into <6.2%, 6.2 to <6.9%, 6.9 <7.4%, 7.4 <8.4%, and 8.4% ≤ as planned (Note; final categorized number of participants was 0 in <6.2% and 6.2 to <6.9% group).|From Baseline, Up to 48 Week|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given populations.|||Percent HbA1c||Standard Deviation|Mean
2598710|NCT02181842|Primary|Changes From Baseline in Glycosylated Hemoglobin (HbA1c) at 48 Week in Participants Stratified by Dose of Pioglitazone|The reported data were changes from baseline in laboratory parameter, that is HbA1c (National Glycohemoglobin Standardization Program Criteria; NGSP), at 48 Week in participants stratified by specific characteristics, mean daily dose of pioglitazone, at the time of enrollment. Mean daily dose of pioglitazone at the time of enrollment were categorized into <15 mg, 15 to <30 mg, 30 <45 mg and 45 mg ≤ as planned (Note; final categorized number of participants was 0 in 45 mg ≤ group).|From Baseline, Up to 48 Week|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given populations.|||Percent HbA1c||Standard Deviation|Mean
2598740|NCT02181738|Secondary|ORR Based on Investigator Assessments for Cohorts A, B, and C|Investigator-assessed ORR and DOR were defined similarly as described for ORR and DOR per IRRC assessment above, but were assessed per investigator using the 2007 IWG criteria.|From the first dose to first progression, death, or start of other therapy up to 28 months|All treated participants|||Percentage of Participants||95% Confidence Interval|Number
2598712|NCT02181842|Primary|Changes From Baseline in Laboratory Parameters (High-Density Lipoprotein Cholesterol (HDL-Cholesterol)) at 48 Week|Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is HDL-Cholesterol as a one of laboratory parameters.|From Baseline, Up to 48 Week|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given populations.|||mg/dL||Standard Deviation|Mean
2598713|NCT02181842|Primary|Changes From Baseline in Laboratory Parameters (Diastolic Blood Pressure (DBP)) at 48 Week|Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is DBP as a one of laboratory parameters.|From Baseline, Up to 48 Week|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given populations.|||mmHg||Standard Deviation|Mean
2598714|NCT02181842|Primary|Changes From Baseline in Laboratory Parameters (Systolic Blood Pressure (SBP)) at 48 Week|Changes from baseline in laboratory parameter at 48 Week were reported. The reported data on this outcome measure is SBP as a one of laboratory parameters.|From Baseline, Up to 48 Week|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given populations.|||mmHg||Standard Deviation|Mean
2598715|NCT02181842|Primary|Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.9 %)|The reported data were percentage of participants who achieved good glycemic control at 48 Week. Good glycemic control was defined with HbA1c (NGSP) Values < 6.9 %.|48 Week|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here ' Number of Participants Analyzed ' is number of participants analyzed at the given populations.|||Percent age of Participants|||Number
2598716|NCT02181842|Primary|Percentage of Participants Achieving Good Glycemic Control (Reduction in Fasting Blood Glucose Level < 130 mg/dL)|The reported data were percentage of participants who achieved good glycemic control at 48 Week. Good glycemic control was defined with fasting blood glucose level < 130 mg/dL.|48 Week|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed ' is number of participants analyzed at the given populations.|||Percentage of Participants|||Number
2598717|NCT02181816|Secondary|Diastolic Office Blood Pressure|Diastolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.|Baseline, Month 1, and final assessment point (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. The number analyzed is the number of participants with data available for analysis at the given time-point.|||mmHg||Standard Deviation|Mean
2598718|NCT02181816|Secondary|Systolic Office Blood Pressure|Systolic office blood pressure level at baseline, Month 1, and the final assessment point (up to Month 12) were reported.|Baseline, Month 1, and final assessment point (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Millimeter of Mercury (mmHg)||Standard Deviation|Mean
2598719|NCT02181816|Primary|Percentage of Participants Who Had One or More Adverse Events||Up to Month 12|Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.|||Percentage of Participants|||Number
2598720|NCT02181803|Secondary|Change From Baseline at Day 13 in Mismatched Negativity (MMN) Area Under Curve (AUC) in Monotherapy MK-8189-treated Schizophrenia Participants|MMN is a response to deviant tone (stimuli) measured in EEG signals. Difference in deviant EEG waveform amplitude from standard amplitude over time indicates MMN; AUC was measured as the product of MMN amplitude and time. Schizophrenic participants show reduced response to deviant stimuli. AUC change from baseline (Day -1) to Day 13 was reported. A higher change indicates improved response to deviant stimuli. Scalp EEG signals were collected using a standard system array of 19 electrodes denoted by nomenclature of scalp placement: C3, C4, Cz, F3, F4, F7, F8, Fp1, Fp2, Fz, O1, O2, P3, P4, Pz, T3, T4, T5, T6. As specified by the protocol, MK-8189 add-on therapy schizophrenia participants (Part 2), healthy participants (Part 3), and all placebo-treated participants were excluded from MMN analyses. Per protocol, MMN analyses were planned and executed in all schizophrenia participants receiving MK-8189 monotherapy, irrespective of different dosing schedules.|Baseline and Day 13|Per protocol, MMN analyses were planned and executed in all Schizophrenia participants receiving MK-8189 monotherapy (irrespective of dosing schedule) with EEG electrode data available. Per protocol, MK-8189 add-on therapy schizophrenia participants (Part 2), healthy participants (Part 3), and all placebo-treated participants were excluded.|||µV*msec||95% Confidence Interval|Mean
2598721|NCT02181803|Secondary|Change From Baseline at Day 13 in Mismatched Negativity (MMN) Peak Amplitude in Monotherapy MK-8189-treated Schizophrenia Participants|MMN is a response to deviant tone (stimuli) measured in electroencephalogram (EEG) signals. Difference in deviant EEG waveform amplitude from standard amplitude over time indicates MMN; this difference at peak waveform is MMN peak amplitude. Schizophrenic participants show reduced response to deviant stimuli. Peak amplitude change from baseline (Day -1) to Day 13 was reported. A higher change indicates improved response to deviant stimuli. Scalp EEG signals were collected using a standard system array of 19 electrodes denoted by nomenclature of scalp placement: C3, C4, Cz, F3, F4, F7, F8, Fp1, Fp2, Fz, O1, O2, P3, P4, Pz, T3, T4, T5, T6. As specified by the protocol, MK-8189 add-on therapy schizophrenia participants (Part 2), healthy participants (Part 3) and all placebo-treated participants were excluded from MMN analyses. Per protocol, MMN analyses were planned and executed in all schizophrenia participants receiving MK-8189 monotherapy, irrespective of different dosing schedules.|Baseline and Day 13|Per protocol, MMN analyses were planned and executed in all Schizophrenia participants receiving MK-8189 monotherapy (irrespective of dosing schedule) with EEG electrode data available. Per protocol MK-8189 add-on therapy schizophrenia participants (Part 2), healthy participants (Part 3) and all placebo-treated participants were excluded.|||µV||95% Confidence Interval|Mean
2608991|NCT02071290|Primary|Plasma IL-8|Change in plasma levels of inflammatory mediator IL-8 over 24 hours from Admission|0 (Admission), 1, 3, 24 hours||||pg/mL||Inter-Quartile Range|Median
2598722|NCT02181803|Primary|Number of Participants Who Discontinue From Study Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE were reported.|Up to Day 14|All participants who received as least one dose of the investigational drug. Per protocol, safety was assessed by part and dose.|||Participants|||Number
2598723|NCT02181803|Primary|Number of Participants Experiencing an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced at least one AE were reported.|Up to Day 28|All participants who received as least one dose of the investigational drug. Per protocol, safety was assessed by part and dose.|||Participants|||Number
2598724|NCT02181803|Primary|Time Required for Plasma Concentration of MK-8189 to Decrease by Half (Apparent t1/2) in Schizophrenia Participants on Day 14|t1/2 was defined as the time required to divide the MK-8189 plasma concentration by half after reaching pseudo-equilibrium. At least three quantifiable post-Cmax, terminal phase concentrations collected were used to calculate the apparent t1/2. Blood samples were collected pre-dose and up to 48 hours post-dose at multiple time points on Day 14 to estimate t1/2 following MK-8189 administration. As specified by the protocol, t1/2 was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, the Day 14 timepoint was not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from t1/2 analysis.|Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48 hours post-dose|Schizophrenia participants who received ≥1 dose of MK-8189, complied with the protocol and had t1/2 data available for Day 14. Due to differing dosing schedules, some time points were not applicable for some arms/doses (indicated by zero participants analyzed). Per protocol healthy participants (Part 3) and placebo arms were excluded.|||hr||Geometric Coefficient of Variation|Geometric Mean
2598725|NCT02181803|Primary|Time Post-dose at Which the Maximum Plasma Concentration (Tmax) of MK-8189 Was Observed in Schizophrenia Participants|Tmax was defined as the time required post dose to reach a maximum plasma concentration of MK-8189. It was estimated as the actual sampling time at the highest MK-8189 plasma concentration. Blood samples were collected pre-dose and up to 48 hours post-dose at multiple time points to estimate Tmax following MK-8189 administration. As specified by the protocol, Tmax was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from Tmax analysis.|Day 1 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose; Days 4, 8, 11 pre-dose and 6, 10, 16, 24 hours post-dose; Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48 hours post-dose|Schizophrenia participants who received ≥1 dose of MK-8189, complied with the protocol and had Tmax data available for Days 1, 4, 8, 11, or 14. Due to differing dosing schedules, some time points were not applicable for some arms (shown by 0 participants analyzed). Per protocol, healthy participants (Part 3) and placebo arms were excluded.|||hr||Full Range|Median
2598726|NCT02181803|Primary|Maximum Observed Post-dose Plasma Concentration (Cmax) of MK-8189 in Schizophrenia Participants|Cmax was defined as the maximum concentration of MK-8189 observed in plasma. Blood samples were collected pre-dose and up to 48 hours post-dose at multiple time points to estimate Cmax following MK-8189 administration. As specified by the protocol, Cmax was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from Cmax analysis.|Day 1 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose; Days 4, 8, 11 pre-dose and 6, 10, 16, 24 hours post-dose; Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48 hours post-dose|Schizophrenia participants who received ≥1 dose of MK-8189, complied with the protocol and had Cmax data available for Days 1, 4, 8, 11, or 14. Due to differing dosing schedules, some time points were not applicable for some arms (shown by 0 participants analyzed). Per protocol, healthy participants (Part 3) and placebo arms were excluded.|||nM||Geometric Coefficient of Variation|Geometric Mean
2598727|NCT02181803|Primary|Area Under the Plasma-concentration Curve at Zero to 24 Hours Post-dose (AUC[0-24hr]) of MK-8189 in Schizophrenia Participants|AUC was defined as a measure of MK-8189 exposure that was calculated as the product of plasma drug concentration and time. The linear-up-log down rule was used to estimate AUC. Blood samples were collected pre-dose and up to 24 hours post-dose to estimate AUC(0-24hr) following MK-8189 administration. As specified by the protocol, AUC(0-24hr) was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from AUC(0-24hr) analysis.|Day 1 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post-dose; Days 4, 8, 11 pre-dose and 6, 10, 16, 24 hours post-dose; Day 14 pre-dose and 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 hours post-dose|Schizophrenia participants who received ≥1 dose of MK-8189, complied with the protocol and had AUC(0-24hr) data available for Days 1, 4, 8, 11, or 14. Due to differing dosing schedules, some time points were not applicable for some arms (shown by 0 participants analyzed). Per protocol, healthy participants (Part 3) and placebo arms were excluded.|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
2598741|NCT02181738|Secondary|Duration of PR in Cohorts A, B, and C|The duration of PR was only evaluated in subjects with BOR of PR and was defined as the time from first documentation of PR to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition.|From the time of the first documented PR up to approximately 28 months|All treated participants|||Months||95% Confidence Interval|Median
2598742|NCT02181738|Secondary|Partial Remission (PR) Rate in Cohorts A, B, and C|The PR rate was defined as the number of subjects with a BOR of PR according to the 2007 IWG criteria, based on IRRC assessment, divided by the number of treated subjects.|From the time of the first documented PR up to approximately 28 months|All treated participants|||Percentage of Participants||95% Confidence Interval|Number
2608992|NCT02071290|Primary|Plasma IL-6|Change in plasma levels of inflammatory mediator IL-6 over 24 hours from Admission|0 (Admission), 1, 3, 24 hours||||pg/mL||Inter-Quartile Range|Median
2598728|NCT02181803|Primary|Plasma Concentration at 24 Hours Post-dose (C24hr) of MK-8189 in Schizophrenia Participants|C24hr was defined as the concentration of MK-8189 observed in plasma at the 24-hour nominal sampling time after administration of MK-8189. In participants receiving MK-8189, blood samples were collected pre-dose and 24 hours post-dose to estimate C24hr following MK-8189 administration. As specified by the protocol, C24hr was analyzed by part, dose and dosing schedule. Due to differing dosing schedules, some time points were not applicable for certain arms/doses as indicated by zero participants analyzed entered in the table. Per protocol, healthy participants (Part 3) and participants receiving placebo were excluded from C24 analysis.|Day 1, 4, 8, 11 and 14 pre-dose and 24 hours post-dose|Schizophrenia participants who received ≥1 dose of MK-8189, complied with the protocol and had C24 data available for Days 1, 4, 8, 11, or 14. Due to differing dosing schedules, some time points were not applicable for some arms (shown by 0 participants analyzed). Per protocol, healthy participants (Part 3) and placebo arms were excluded.|||nM||Geometric Coefficient of Variation|Geometric Mean
2598729|NCT02181790|Primary|Change in Dermatology Life Quality Index (DLQI) at Week 8 From Baseline|reduction in DLQI from baseline after 16 treatments with the excimer laser in the first phase of the study|baseline and week 8|study terminated before study completion, no data collected||||||
2598730|NCT02181790|Primary|Psoriasis Area and Severity Index (PASI)|The percentage of patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI) from baseline after 16 treatments with the excimer laser in the first phase of the study.|baseline and week 12|study terminated before study completion, no data collected||||||
2598731|NCT02181738|Secondary|Incidence of Grade 3-4 Laboratory Abnormalities in Cohort D|Specific laboratory abnormalities (worst grade).|From last dose up to 120 days|All treated participants|||Pariticipants|||Number
2598732|NCT02181738|Secondary|Incidence of Select AEs in Cohort D|Select AEs have been categorized into seven areas: pulmonary toxicity, gastrointestinal toxicity, hepatotoxicity, endocrinopathy, skin toxicity, neurological toxicity and renal toxicity. Select AEs, in particular pneumonitis, are considered clinically meaningful as they require greater vigilance and for early recognition and prompt intervention.|From last dose up to 120 days|All treated participants|||Participants|||Number
2598733|NCT02181738|Secondary|Incidence of AEs Leading to Dose Delay in Cohort D|Safety was analyzed through the incidence of deaths, adverse events, serious adverse events, adverse events leading to discontinuation, adverse events leading to dose delay, select adverse events and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety of subjects was analyzed per treatment phase (monotherapy phase, combination therapy phase) and overall.|From last dose up to 120 days|All treated participants|||Participants|||Number
2598734|NCT02181738|Secondary|Incidence of AEs Leading to Discontinuation in Cohort D|Safety was analyzed through the incidence of deaths, adverse events, serious adverse events, adverse events leading to discontinuation, adverse events leading to dose delay, select adverse events and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety of subjects was analyzed per treatment phase (monotherapy phase, combination therapy phase) and overall.|From last dose up to 120 days|All treated participants|||Participants|||Number
2598735|NCT02181738|Secondary|Incidence of Serious Adverse Events (SAEs) in Cohort D|Safety was analyzed through the incidence of deaths, adverse events, serious adverse events, adverse events leading to discontinuation, adverse events leading to dose delay, select adverse events and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety of subjects was analyzed per treatment phase (monotherapy phase, combination therapy phase) and overall.|From last dose up to 120 days|All treated participants|||Participants|||Number
2598736|NCT02181738|Secondary|Incidence of Adverse Events (AEs) in Cohort D|Safety was analyzed through the incidence of deaths, adverse events, serious adverse events, adverse events leading to discontinuation, adverse events leading to dose delay, select adverse events and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety of subjects was analyzed per treatment phase (monotherapy phase, combination therapy phase) and overall.|From last dose up to 120 days|All treated participants|||Participants|||Number
2598737|NCT02181738|Secondary|Incidence of Deaths in Cohort D|Safety was analyzed through the incidence of deaths, adverse events, serious adverse events, adverse events leading to discontinuation, adverse events leading to dose delay, select adverse events and specific laboratory abnormalities (worst grade). Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety of subjects was analyzed per treatment phase (monotherapy phase, combination therapy phase) and overall.|From first dose up to 28 months|All treated participants|||Participants|||Number
2598738|NCT02181738|Secondary|Treatment Discontinuation Rate in Cohort D|Subjects were treated with four doses of nivolumab flat dose 240 mg IV every 2 weeks (monotherapy phase), followed by twelve doses of the combination of AVD (Adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase). Each 28-day dosing period constituted a Combocycle: two doses of the combination therapy per cycle, except for Combocycle 6, which was only a 15-day cycle. The combination therapy was administered every 2 weeks for 12 doses (two doses, Dose 1 on Day 1 and Dose 2 on Day 15, of each Combocycle x 6 cycles). The combination phase ended at Dose 2 (Day 15) of Combocycle 6. The primary analysis for Cohort D was conducted when all treated patients for Cohort D had completed follow-up visit 1 and end-of- therapy response assessment. All analyses for Cohort D were performed separately from other cohorts.|From date of first dose to end of combination therapy up to 28 months|All treated participants|||Percentage of Participants|||Number
2598739|NCT02181738|Secondary|Duration of Objective Response (DOR) Based on Investigator Assessments in Cohorts A, B, and C|Investigator-assessed ORR and DOR were defined similarly as described for ORR and DOR per IRRC assessment above, but were assessed per investigator using the 2007 IWG criteria.|From the date of first study drug dose up to approximately 28 months|All treated participants|||Months||95% Confidence Interval|Median
2599934|NCT02169219|Secondary|Partial Remission|Number of patients entering partial remission, defined as no new disease manifestations, no worsening of existing disease and BVAS/WG < 3.|8 weeks||||Participants|||Count of Participants
2598743|NCT02181738|Primary|Number of Participants Who Experienced at Least One Treatment Related Grade 3-5 AE in Cohort D|To evaluate the safety and tolerability of nivolumab monotherapy during the monotherapy phase and the safety and tolerability of nivolumab in combination with AVD during the combination phase|From last dose up to 120 days|All treated participants|||Participants|||Number
2598744|NCT02181738|Primary|Duration of Complete Remission (CR) for Cohorts A, B, and C|The CR rate was defined as the number of subjects with a BOR of CR according to the 2007 IWG criteria, based on IRRC assessment, divided by the number of treated subjects. The duration of CR was only evaluated in subjects with BOR of CR and was defined as the time from first documentation of CR (the date of first negative FDG-PET scan or the date of first documentation of no disease involvement in the bone marrow (if required), whichever occurred later) to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition.|from date of first documented CR up to approximately 28 months|All treated participants|||Months||95% Confidence Interval|Median
2598745|NCT02181738|Primary|Complete Remission Rate in Cohorts A, B, and C|The CR rate was defined as the number of subjects with a BOR of CR according to the 2007 IWG criteria, based on IRRC assessment, divided by the number of treated subjects.|From the date of first study drug dose up to approximately 28 months|All treated participants|||Percentage of Participants||95% Confidence Interval|Number
2598746|NCT02181738|Primary|Duration of Objective Response in Cohorts A, B, and C|DOR was defined as the time from first response (CR or PR) to the date of the first documented tumor progression as determined by the investigator using the 2007 IWG criteria or death due to any cause, whichever occurred first. Appearance of any new lesion > 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size. Increased FDG uptake in a previously unaffected site should only be considered relapsed or PD after confirmation with other modalities.|From the date of first study drug dose up to approximately 28 months|All treated participants|||Months||95% Confidence Interval|Median
2598747|NCT02181738|Primary|Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C|To assess the clinical benefit of nivolumab, as measured by ORR based on IRRC assessment, and defined as proportion of subjects achieving either a PR or CR according to the 2007 IWG criteria. Analyses of efficacy endpoints were performed separately for each cohort, according to IWG 2007. For cohort A and B, if the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. For cohort C, no evidence of FDG-avid disease in bone marrow will be required in all patients in lieu of bone marrow aspirate/ biopsy.|From the date of first study drug dose up to approximately 28 months|All treated participants|||Percentage of Particpants||95% Confidence Interval|Number
2598748|NCT02181673|Secondary|Change From Baseline in Short Form-36 Health Survey (SF)-36 Mental Component Summary (MCS) at Week 14|The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary mental component score (MCS) is derived. Scales contributing most to the scoring of the SF-36 MCS include the VT, SF, RE and MH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary MCS score is also scaled from 0 to 100 with higher scores indicating better health.|Baseline and Week 14|"The full analysis set (FAS) included all participants who were randomized. Here N (number of participants analyzed) signifies the number of participants evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
2598749|NCT02181673|Secondary|Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 14|The ACR 70 response is defined as greater than or equal to (>=) 70 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=70% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter [cm] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).|Week 14|The full analysis set (FAS) included all participants who were randomized.|||Percentage of participants|||Number
2598750|NCT02181673|Secondary|Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24|The ACR 50 response is defined as greater than or equal to (>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter [cm] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).|Week 24|The full analysis set (FAS) included all participants who were randomized.|||Percentage of participants|||Number
2598751|NCT02181673|Secondary|Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) at Week 14|The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health.|Baseline and Week 14|"The full analysis set (FAS) included all participants who were randomized. Here N (number of participants analyzed) signifies the number of participants evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
2608993|NCT02071290|Primary|Plasma TNF-α|Change in plasma levels of inflammatory mediator TNF-α over 24 hours from Admission|0 (Admission), 1, 3, 24 hours||||pg/mL||Inter-Quartile Range|Median
2598752|NCT02181673|Secondary|Change From Baseline in Dactylitis Scores at Week 14 in Participants With Dactylitis at Baseline|Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness.|Baseline and Week 14|"Population included all Randomized participants With Dactylitis (Score >0) at Baseline. Here N (number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
2598753|NCT02181673|Secondary|Change From Baseline in Leeds Enthesitis Index (LEI) at Week 14 in Participants With Enthesitis at Baseline|Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness).|Baseline and Week 14|"Population included all randomized participants with Enthesitis at Baseline. Here N (number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
2598754|NCT02181673|Secondary|Change From Baseline in Total Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24|The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively.|Baseline and Week 24|FAS for structural damage endpoints (FAS-SD) defined as participants in the FAS who were treated and had a non-missing baseline total modified vdH-S score for the analysis.|||units on a scale||Standard Error|Mean
2598755|NCT02181673|Secondary|Percentage of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 14|The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.|Week 14|The analysis set included randomized participants with greater than or equal to (>=) 3 percent (%) body surface area (BSA) Psoriasis Skin Involvement at Baseline.|||Percentage of participants|||Number
2598756|NCT02181673|Secondary|Percentage of Participants Who Achieved an ACR 50 Response at Week 14|The ACR 50 response is defined as: greater than or equal to (>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 cm scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).|Week 14|The full analysis set (FAS) included all participants who were randomized.|||Percentage of Participants|||Number
2598757|NCT02181673|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 14|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Week 14|"The full analysis set (FAS) included all participants who were randomized. Here N (number of participants analyzed) signifies the number of participants who were evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
2598758|NCT02181673|Primary|Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14|The ACR 20 response is defined as greater than or equal to (>=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=20% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter [cm] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP).|Week 14|The full analysis set (FAS) included all participants who were randomized.|||Percentage of Participants|||Number
2598759|NCT02181634|Other Pre-specified|Banking Biospecimens for Future Assessment|Optional specimen banking of patient blood specimens (including serum, plasma and buffy coat) as well as fixed left-over tissue specimens when available from all enrolled patients in this trial for possible future molecular, pharmacogenomic, and/or proteomic testing.|Prior to Cycle 1, Day 1; Cycle 1, Day 8; Cycle 3, Day 1 and at Off Treatment|||||||
2598760|NCT02181634|Other Pre-specified|hENT Expression|Correlate hENT1 (high versus low) expression by IHC with median PFS, OS, TTP, ORR and DCR.|Baseline|||||||
2598761|NCT02181634|Other Pre-specified|CDA Expression|Correlate CDA (high versus low) expression by IHC with median PFS, OS, TTP, ORR and DCR.|Baseline|||||||
2598762|NCT02181634|Other Pre-specified|Fibrosis Expression|Correlate fibrosis (low, intermediate and high) by trichrome staining with median PFS, OS, TTP, ORR and DCR.|Baseline|||||||
2598763|NCT02181634|Other Pre-specified|Stromal SPARC Expression|Correlate stromal SPARC (high versus low) expression by immunohistochemistry (IHC) with median PFS, OS, TTP, ORR and DCR.|Baseline|||||||
2598764|NCT02181634|Other Pre-specified|Change in Circulating Tumor Cells (CTCs)|Correlate change in CTCs to median PFS, OS, TTP, ORR and DCR.|Prior to Cycle 1, Day 1; Cycle 1 Day 8; Cycle 3, Day 1 and at Off Treatment|||||||
2598765|NCT02181634|Secondary|Association Between OS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline|Patients were dichotomized into maximum CA 19-9 decline >=50% and maximum CA 19-9 decline <50%. Cox proportional hazards model was used to evaluate the association between OS and maximum change in CA 19-9.|CA 19-9 was evaluated every 8 weeks until progression or for up to 3 years and off-treatment|Eligible and treated patients with CA 19-9 data available|||months||95% Confidence Interval|Median
2598766|NCT02181634|Secondary|Association Between PFS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline|Patients were dichotomized into maximum CA 19-9 decline >=50% and maximum CA 19-9 decline <50%. Cox proportional hazards model was used to evaluate the association between PFS and maximum change in CA 19-9.|CA 19-9 was evaluated every 8 weeks until progression or for up to 3 years and off-treatment|Eligible and treated patients with CA 19-9 data available|||months||95% Confidence Interval|Median
2598767|NCT02181634|Secondary|Disease Control Rate (DCR)|Disease control rate is the proportion of patients achieved complete response, partial response or stable disease per RECIST version 1.1. Complete response is defined as disappearance of all lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters/axes of target lesions and the persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker levels above the normal limits. Stable disease is defined as neither sufficient shrinkage to qualify for complete or partial response nor sufficient increase to qualify for progression. A confirmation assessment performed >=4 weeks after the criteria for response is met is required.|Every 3-6 months for up to 3 years|Eligible and treated patients|||proportion of participants||95% Confidence Interval|Number
2598768|NCT02181634|Secondary|Overall Response Rate (ORR)|Overall response rate is defined as the proportion of patients with complete response or partial response per RECIST version 1.1. Complete response is defined as disappearance of all lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters/axes of target lesions and the persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker levels above the normal limits. A confirmation assessment performed >=4 weeks after the criteria for response is met is required.|Every 3-6 months for up to 3 years|Eligible and treated|||proportion of participants||95% Confidence Interval|Number
2598769|NCT02181634|Secondary|Time To Progression (TTP)|TTP was defined as the time from date of first dose of study therapy to date of removal from study for progression. Patients who have not experienced progression were censored at the date of last disease evaluation. Progression is evaluated using Solid Tumor Response Criteria (RECIST) Version 1.1. Progression is defined as at least a 20% increase in the sum of the diameters/axes of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm over the nadir. The appearance of new lesions or unequivocal progression of existing non-target lesions also constitutes disease progression.|Every 3-6 months for up to 3 years|Eligible and treated|||months||95% Confidence Interval|Median
2598770|NCT02181634|Secondary|Progression-free Survival (PFS)|Progression-free survival is defined as the time from the date of first study treatment to either the date of documented disease progression or death from any cause, whichever occurred first.|Every 3-6 months for up to 3 years|Eligible and treated patients|||months||95% Confidence Interval|Median
2598771|NCT02181634|Secondary|Overall Survival (OS)|OS is defined as the time from enrollment until death or last patient contact.|Every 3-6 months for up to 3 years|Eligible and treated|||months||95% Confidence Interval|Median
2598772|NCT02181634|Primary|Progression-Free Survival (PFS) Rate at 6 Months (Proportion of Participants Alive and Progression-Free at 6 Months)|"Progression-free survival is defined as the time from the date of first study treatment to either the date of documented disease progression or death from any cause, whichever occurred first. Progression-free survival rate at 6 months is defined as the proportion of patients who were disease progression-free and alive at 6 months.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameter/axes of target lesions, taking as reference the smallest sum on study, or unequivocal progression of existing non-target lesions, or the appearance of new lesions."|Assessed at 6 months|Eligible and treated|||proportion of participants||95% Confidence Interval|Number
2598773|NCT02181530|Secondary|Time to OZURDEX® Re-Injection in the Study Eye||Up to 17 Months|All participants who had OZURDEX® re-injection.|||days||Standard Deviation|Mean
2598774|NCT02181530|Secondary|Time to Improvement of 3 Lines or More in BCVA in the Study Eye|"BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as approxETDRS letters to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 3 or more lines is reported."|Baseline, Up to 17 Months|All participants with improvement of 3 lines or more in BCVA.|||days||Standard Deviation|Mean
2598775|NCT02181530|Secondary|Time to Improvement of 2 Lines or More in BCVA in the Study Eye|"BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as approxETDRS letters to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. The time in days to improvement of 2 or more lines is reported."|Baseline, Up to 17 Months|All participants with improvement of 2 lines or more in BCVA.|||days||Standard Deviation|Mean
2598776|NCT02181530|Secondary|Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)|OCT is measured in the study eye following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement|Baseline, 7 to 12 weeks following the first OZURDEX® injection|All participants with data available at the given time-point.|||μm||Standard Deviation|Mean
2598852|NCT02181127|Secondary|Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All CGMG Measurements: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl, >180 mg/dl, >250 mg/dl||from t=0 to stud stop after 2 weeks||||percentage of time||Standard Deviation|Mean
2598777|NCT02181530|Secondary|Percentage of Patients With an Increase of 3 Lines or More in BCVA in the Study Eye|"BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate ETDRS letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as approxETDRS letters to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 3 lines or more indicates an improvement."|Baseline, Up to 17 Months|All participants.|||percentage of participants|||Number
2598778|NCT02181530|Secondary|Percentage of Patients With an Increase of 2 Lines or More in BCVA in the Study Eye|"BCVA following the injection of OZURDEX® is measured in the study eye using a special eye chart. BCVA measurements expressed in Snellen fractions were converted to logMAR units and approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores based on the formula: approximate ETDRS letters = 85 + 50 x log10 (Snellen fraction). The converted scores hereinafter are referred to as approxETDRS letters to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. It was assumed that one line equals five ETDRS points. An increase of 2 lines or more indicates an improvement."|Baseline, Up to 17 Months|All participants.|||percentage of participants|||Number
2598779|NCT02181530|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart. The number of letters read correctly Snellen fraction are converted to a decimal scale. There are 11 lines on a standard Snellen chart ranging from 0.1 (20/200) at worst to 2.0 (20/10) at best. 20/20 on the decimal scale is equal to 1.0. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision has improved.|Baseline, 7 to 12 weeks following the first OZURDEX® injection|All participants with data available at the time-point.|||units on a scale||Standard Deviation|Mean
2598780|NCT02181517|Secondary|Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline, Week 16, Week 20|mITT population included all randomized and treated participants with at least 1 follow-up visit.|||microns||Standard Deviation|Mean
2598781|NCT02181517|Secondary|Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using the ETDRS Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 20|mITT population included all randomized and treated participants with at least 1 follow-up visit.|||percentage of participants|||Number
2598782|NCT02181517|Secondary|Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using the ETDRS Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 20|mITT population included all randomized and treated participants with at least 1 follow-up visit.|||percentage of participants|||Number
2598783|NCT02181517|Secondary|Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 20|mITT population included all randomized and treated participants with at least 1 follow-up visit.|||letters||Standard Deviation|Mean
2598784|NCT02181517|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 16|Modified Intent-to-Treat (mITT) population included all randomized and treated participants with at least 1 follow-up visit.|||letters||Standard Deviation|Mean
2598785|NCT02181504|Secondary|Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye|CRT is assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening.|Baseline, Week 16, Week 20|Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit|||microns||Standard Deviation|Mean
2598786|NCT02181504|Secondary|Percentage of Patients With a BCVA Gain of ≥10 Letters in the Study Eye on the ETDRS Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of patients with a BCVA gain of ≥10 letters are noted.|Baseline, 20 Weeks|Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit|||Percentage of Patients|||Number
2598825|NCT02181231|Primary|Antidepressant Side Effect Checklist (ASEC)|Measure of side effects, consisting of 21 items, ranging from 0-3 (0 indicates no side effect, 3 indicates severe side effect). We calculated the total final score for the 21 items (total range is 0-63). A higher total number represents a greater severity in reported side effects. We calculated the mean change in side effects for both groups using baseline and 8 week data.|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2598787|NCT02181504|Secondary|Percentage of Patients With a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale|BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of patients with a BCVA gain of ≥15 letters are noted.|Baseline, 20 Weeks|Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit|||Percentage of Patients|||Number
2598788|NCT02181504|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened.|Baseline, Week 20|Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit|||Letters||Standard Deviation|Mean
2598789|NCT02181504|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened.|Baseline, Week 16|Modified Intent-to-Treat: all randomized and treated patients with at least 1 follow-up visit|||Letters||Standard Deviation|Mean
2598790|NCT02181426|Primary|PACU Opiate Consumption|Total PACU opioid consumption measured in intravenous morphine mg equivalents (IV MME).|Less than 1 day (PACU stay in the postoperative period)|The study enrolled 112 patient with 28 patients randomized to each group.|||IV Morphine Equivalents (mg)||Standard Error|Mean
2598791|NCT02181413|Secondary|Time to Improvement of PN Events|PN is defined as the treatment-emergent adverse event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to the Medical Dictionary for Regulatory Activities (MedDRA). A PN event is considered as resolved if its final outcome is resolved with no subsequent PN event of the same preferred term occurring on the resolution date or the day before and after. A PN event is considered as improved if the event improves from the maximum grade. That is, all the grades recorded after the maximum grade is less than the maximum grade. Time to improvement is defined as the time from the initial onset date (inclusive) of the maximum grade to the first onset date that the toxicity grade is below the maximum grade with no higher grade thereafter, or the resolution date, whichever occurs first.|From randomization date through 30 days after the last dose of drug (up to 24 months)|||||||
2598792|NCT02181413|Secondary|Time to Resolution of Peripheral Neuropathy (PN) Events|Peripheral neuropathy is defined as the treatment-emergent adverse event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to Medical Dictionary for Regulatory Activities (MedDRA). A PN event is considered as improved if the event improves from the maximum grade. That is, all the grades recorded after the maximum grade is less than the maximum grade. Time to improvement is defined as the time from the initial onset date (inclusive) of the maximum grade to the first onset date that the toxicity grade is below the maximum grade with no higher grade thereafter, or the resolution date, whichever occurs first.|From randomization date through 30 days after the last dose of drug (up to 24 months)|||||||
2598793|NCT02181413|Secondary|Plasma Concentration of Ixazomib|Plasma concentrations of the complete hydrolysis product of ixazomib citrate (ixazomib) will be measured using a validated Liquid Chromatography-tandem Mass Spectrometry (LC/MS/MS) assay.|Day 1 of Cycle 1 at multiple time points (up to 4 hours) post-dose; Days 8 and 15 of Cycle 1, Days 1 and 8 of Cycle 2, Day 1 of Cycles 3 through 10 (each cycle of 28 days) predose|||||||
2598794|NCT02181413|Secondary|Health-related Quality of Life (HRQL) Score Based on The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Quality of Life Domain|EORTC QLQ-C30 is completed by the participants. The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best).|Baseline up to PD (up to Month 107)|||||||
2598795|NCT02181413|Secondary|Number of Participants With Markedly Abnormal Clinical Laboratory Values||Baseline through 30 days after the last dose of study drug (up to 24 months)|||||||
2598796|NCT02181413|Secondary|Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) or Serious Adverse Events (SAEs)||First dose of study drug through 30 days after last dose of study drug (up to 24 months)|||||||
2598797|NCT02181413|Secondary|Eastern Cooperative Oncology Group (ECOG) Performance Score|The ECOG performance is a 6-point scale used by doctors to assess how a participant's disease is progressing, how the disease affects the participant's daily life, and to determine appropriate treatment and prognosis. The scale is 0=Normal activity. Fully active, able to carry on all pre disease performance without restriction (best) to 5=Dead.|Baseline up to EOT (24 months), thereafter every 4 weeks until initiation of next line therapy|||||||
2598826|NCT02181231|Primary|Frequency, Intensity, and Burden of Side Effects Rating (FIBSER)|"Three item side effect scale used to assess frequency and intensity of side effects (range 0-6 for each item). We calculated the total score of all three items (range 0-18) with lower numbers indicating less frequency.~We calculated the mean score at baseline and week 8 (final timepoint)."|Week 1 and week 8||||score on a scale||Standard Deviation|Mean
2598827|NCT02181231|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|Measure of depression severity, range of 0-60, with higher scores indicating more severe depression. We calculated the mean change in depression for both groups using baseline MADRS and week 8 MADRS scores.|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2598798|NCT02181413|Secondary|PFS Benefits in a High-Risk Population|High-risk population will include but not be limited to participants carrying deletion (del)17, t(4:14), t(14:16), amplification (ampl) 1q, del13, or del1p. PFS is defined as the time from the date of randomization to the date of first documentation of PD, as evaluated by an independent review committee according to IMWG criteria, or death due to any cause (whichever occurs first). PD is defined as >=25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be >10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be >=10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development.|Randomization up to Month 107|||||||
2598799|NCT02181413|Secondary|OS Benefits in a High-Risk Population|High-risk population will include but not be limited to participants carrying deletion (del)17, t(4:14), t(14:16), amplification (ampl) 1q, del13, or del1p. OS will be measured as the time from the date of randomization to the date of death.|Randomization up to Month 107|||||||
2598800|NCT02181413|Secondary|Correlation Between MRD Status and Progression Free Survival (PFS) and Overall Survival (OS)|Degree of correlation will be determined between 2 methodologies for MRD assessment (8-color flow cytometry, next-generation sequencing and bone marrow aspirates and blood samples). Association between MRD status with PFS and OS will be evaluated independently from the methodology used for the assessment. The association between MRD status and PFS and OS will be evaluated in both study arms, and concordance between flow cytometry and sequencing readouts will be assessed.|Baseline up to Month 107|||||||
2598801|NCT02181413|Secondary|Number of Participants With Conversion From Minimal Residual Disease (MRD) Positive to MRD Negative, and Maintenance of MRD Negativity|MRD negativity is defined as absence of MRD and MRD positivity is defined as presence of MRD. The conversion rate from MRD positive to MRD negative and the maintenance of MRD negativity will be assessed and reported. Bone marrow aspirates and blood samples will be sent to a central laboratory and will be assessed for MRD using flow cytometry and a sequencing methodology.|Baseline up to EOT (24 months)|||||||
2598802|NCT02181413|Secondary|Percentage of Participants Who Develop A New Primary Malignancy||Baseline until death or termination of the study (up to Month 107)|||||||
2598803|NCT02181413|Secondary|Duration of the Next Line of Therapy|Duration of the next line of therapy is defined as the time from the date of the first dose of the next line of therapy to the date of the last dose of the next antineoplastic therapy following study treatment or death due to any cause, whichever occurs first. Duration of the next line of therapy will be analyzed on those participants who actually received the next line of therapy following the study treatment and duration would be summarized using Kaplan-Meier method. Participants who are still on treatment on the next line of therapy will be censored at last visit.|From the start of next line therapy after PD to the last dose of next line therapy (up to Month 107)|||||||
2598804|NCT02181413|Secondary|Time to End of the Next Line of Therapy|Time to end of the next line of therapy is defined as the time from the date of randomization to the date of last dose of the next line of antineoplastic therapy following study treatment or death due to any cause, whichever occurs first.|Baseline up to end of next line of therapy (Month 107)|||||||
2598805|NCT02181413|Secondary|Time to Start of the Next Line of Therapy|Time to start of the next line of therapy was defined as the time from the date of randomization to the date of initiation dose of the next line of antineoplastic therapy following study treatment or death due to any cause, whichever occurs first.|Baseline up to start of next line of therapy (after 24 months treatment period followed by every 4 weeks PFS and PD follow up period)|||||||
2598806|NCT02181413|Secondary|Second Progression Free Survival (PFS2)|PFS2 is defined as the time from the date of randomization to the date of objective disease progression on next line treatment or death from any cause (whichever occurs first). PD is defined as >=25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be >10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be >=10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development.|Baseline up to EOT (24 months); thereafter followed up every 4 weeks until initiation of next-line therapy and then every 12 weeks until second progressive disease (PD2) or death (up to Month 107)|||||||
2598807|NCT02181413|Secondary|Time to Progression (TTP)|TTP is defined as the time from the date of randomization to the date of first documentation of PD , using IMWG criteria. PD is defined as >=25% increase from lowest value in: serum/urine M-component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels must be >10mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must be >=10%;new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development.|Baseline until PD (Month 107)|||||||
2598808|NCT02181413|Secondary|Percentage of Participants With Any Best Response Category Before PD or Subsequent Therapy|Response was assessed according to IMWG criteria. Best response includes PR, VGPR and CR. PR as per IMWG criteria is 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by greater than or equal to (>=) 90% or to less than (<) 200 milligram (mg) per 24 hours. VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours. CR is negative immunofixation of serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow. Stringent CR (sCR) is CR and normal FLC ratio and absence of clonal PCs by immunohistochemistry or 2- to 4-color flow cytometry.|Baseline up to EOT (24 months) and thereafter every 4 weeks until initiation of the next line of therapy (up to 107 months)|||||||
2598809|NCT02181413|Secondary|Overall Survival (OS)|OS was measured as the time from the date of randomization to the date of death.|Baseline up to Follow up period (107 months)|||||||
2598828|NCT02181140|Secondary|Complication Rates|Complication rates of EUS FNA|day 0 and day 14||||participants|||Number
2598829|NCT02181140|Secondary|EUS Pro Core FNA: Histology Samples|Histology (not cytology) samples for Pro-core Needle: Number of adequately evaluable histology samples|day 0 and day 14|Histology (not cytology) samples for Pro-core Needle|||participants|||Number
2598810|NCT02181413|Primary|Progression Free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD), as evaluated by an independent review committee according to International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occured first. PD was defined as ≥25% increase from lowest value in: serum/urine M component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved free light chain (FLC) levels must be >10 mg/dL; participants without measurable serum, urine M-protein levels and FLC levels, bone marrow plasma cell percent must have been ≥10%; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size increase; hypercalcemia development.|Randomization up to End of treatment (EOT) (24 months); thereafter followed up every 4 weeks until progression of disease or death (to data cutoff: approximately 4 years)|Intent-to-Treat (ITT) population was defined as all participants who were randomized and had post randomization data. Participants without documentation of PD were censored at the date of last response assessment that was stable disease (SD) or better.|||months||95% Confidence Interval|Median
2598811|NCT02181400|Secondary|Change in Logmar Best Corrected Visual Acuity (BCVA) at Two Months|Change in Logmar Best corrected visual acuity (BCVA) from 2 month to that measured at baseline|Change from baseline BCVA measured at two months||||letters||Standard Deviation|Mean
2598812|NCT02181400|Secondary|Change in Logmar Best Corrected Visual Acuity (BCVA) at One Month.|Change in Logmar Best corrected visual acuity (BCVA) from 1 month to that measured at baseline|Change from baseline BCVA measured at one month||||letters||Standard Deviation|Mean
2598813|NCT02181400|Primary|Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography at Two Months.|The change in total macular volume was taken as the difference between the total macular volume as measured by Spectral Domain Optical Coherence Tomography at 2 month and the total macular volume at baseline|Change from baseline total macular volume as measured by OCT at two months||||millimeters cube||Standard Deviation|Mean
2598814|NCT02181400|Primary|Change in Total Macular Volume as Measured by Spectral Domain Optical Coherence Tomography at One Month.|The change in total macular volume was taken as the difference between the total macular volume as measured by Spectral Domain Optical Coherence Tomography at 1 month and the total macular volume at baseline|Change from baseline total macular volume at one month||||millimeter cube||Standard Deviation|Mean
2598815|NCT02181400|Primary|Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography (OCT) at Two Months|Change in measurement (in microns) in central macular thickness as measured by Spectral Domain Optical Coherence Tomography (OCT)|Change from baseline central macular thickness at two months||||micrometers||Standard Deviation|Mean
2598816|NCT02181400|Primary|Change in Measurement in Central Macular Thickness Measured by Spectral Domain Optical Coherence Tomography( OCT) at One Month|Change in measurement( in microns) in central macular thickness as measured by Spectral Domain Optical Coherence Tomography( OCT)|Change from baseline in central macular thickness at one month||||micrometers||Standard Deviation|Mean
2598817|NCT02181387|Primary|Neuraxial Analgesic Drug Consumption Per Hour|subject evaluated every 2 hours with the amount of neuraxial analgesia consumed during that time period. Study med administered up to 24 hours. labor analgesia continue until delivery.|up to 24 hours||||milliliters||Standard Deviation|Mean
2598818|NCT02181296|Secondary|Opioid Requirements for 72 Hours After Surgery|in the milligram equivalent of codeine, using web-based opioid dose converter|72 hours|used nonparametric test to compare between the two groups. the discrepancy of the number of patients analyzed and participants have been previously explained|||milligrams||Inter-Quartile Range|Median
2598819|NCT02181296|Secondary|Percentage Change in Forced Expired Volume in First Second (FEV1) After the Block|FEV1 was measured within 30 minutes of arrival to PACU. The outcomes represent the percentage change from the preoperative value to the value measured in PACU (Post-Anesthesia Care Unit). The negative value represents the decrease in the FEV1 value.|within 30 minutes from arrival to PACU|participants post-block within 30 minutes from arrival to PACU. we had three patients with missing data on these value and hence the discrepancy between the number of patients enrolled and the number of patients analyzed ( 2 patient from the 0.1% group had missing data and one patient from the 0.2% had missing data)|||Percentage of change of FEV1||Inter-Quartile Range|Median
2598820|NCT02181296|Secondary|Percentage Change of Forced Vital Capacity (FVC) From Pre-block Value to Value Measures in PACU|The percentage change in the FVC from preblock value to values measured in PACU. The negative value represents the decrease in the FVC value.|within 30 minutes from arrival to PACU|FVC measured within 30 minutes from arrival to PACU. We had missing data on three patients ( 2 in the 0.1% ropivacaine and 1 from the 0.2% ropivacaine group)|||percentage of change in FVC||Inter-Quartile Range|Median
2598821|NCT02181296|Primary|Number of Patients With Paradoxical Diaphragmatic Movement|The primary outcome variable is the number of patients with paradoxical diaphragmatic movement ( as an indication for phrenic nerve blockade) as assessed by ultrasonographic evaluation of diaphragm|30 minutes after the block|Paradoxical diaphragm movement at 30 min after the block. we had missing data on 3 patients ( 2 from the 0.1% group and 1 from the 0.2% group)|||Participants|||Count of Participants
2598822|NCT02181231|Secondary|Numeric Scale of Pain (NRS-P)|"Measure used to assess pain, ranging from 0-10, with 10 being the worst possible pain.~We calculated the mean change in pain for both groups using baseline and week 8 (last time point)."|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2598823|NCT02181231|Secondary|Brief Symptom Inventory-Anxiety Subscale (BSI)|Measure of anxiety. Six anxiety symptoms are rated based on how distressed the subject is for each symptom. The range for each symptom is 0-4, with 4 representing extreme distress. We computed the mean of the final BSI score (range 0-24), with a lower number indicating a better outcome. We also calculated the mean change in anxiety for both groups using baseline and Phase 2 week 8 (final time point) data.|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2598824|NCT02181231|Secondary|Suicide Ideation Scale (SIS)|A 19 item scale used to measure the presence or absence of suicidal ideations and the degree of severity of suicidal ideas. For this study, we computed the total score for all 19 items (total range 0-90). Higher scores represent a worse outcome. We also calculated the mean change in suicidal ideation for both groups using baseline and week 8 (final timepoint).|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2598830|NCT02181140|Primary|Diagnostic Accuracy|"Diagnostic accuracy of Pro-core needle (22 G) will be compared to conventional fine needle aspiration (22 G). Therefore EUS-FNA with both needles is undertaken in a random order in each lesion. For Pro-core needle, a histological / cytological diagnosis and quality assessment will be made by pathologists.For Echotip aspiration needle, reference cytology evaluation is done by cytology experts.~The histopathological diagnosis after surgery or the clinical follow up of at least one year after EUS FNA is current standard."|up to 1 year||||Diagnostic accuracy (%)|||Number
2598831|NCT02181127|Secondary|Episodes of Nausea Per Day on Glucagon vs Placebo||from t=0 to study stop after 2 weeks||||episodes of nausea per day||Standard Deviation|Mean
2598832|NCT02181127|Secondary|Total Glucagon Dosing (mcg/kg/24 Hours)||from t=0 to study stop after 2 weeks||||mcg/kg/day||Standard Deviation|Mean
2598833|NCT02181127|Secondary|Total Number of Grams of Carbohydrate Taken for Hypoglycemia Overnight (11:00 PM - 7:00 AM)|Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated|2 weeks|Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated||||||
2598834|NCT02181127|Secondary|Number of Carbohydrate Interventions for Hypoglycemia Overnight (11:00 PM - 7:00 AM)|Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated|2 weeks|Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated||||||
2598835|NCT02181127|Secondary|Total Number of Grams of Carbohydrate Taken for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM)|Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated|2 weeks|Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated||||||
2598836|NCT02181127|Secondary|• Number of Carbohydrate Interventions for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM)|Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated|2 weeks|Timing of carbohydrate consumption for treatment of hypoglycemia was not collected during the study, so this outcome cannot be calculated||||||
2598837|NCT02181127|Secondary|Insulin Total Daily Dose||from t=0 to study stop after 2 weeks||||units per day||Standard Deviation|Mean
2598838|NCT02181127|Secondary|Total Number of Grams of Carbohydrate Taken for Hypoglycemia||from t=0 to study stop after 2 weeks||||grams per day||Standard Deviation|Mean
2598839|NCT02181127|Secondary|Number of Carbohydrate Interventions for Hypoglycemia||from t=0 to study stop after 2 weeks||||number of interventions per day||Standard Deviation|Mean
2598840|NCT02181127|Secondary|• Fraction of BG Values < 70 During Exercise Fraction of BG Values < 70 During Exercise|Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.|2 weeks|Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.||||||
2598841|NCT02181127|Secondary|Mean BG During Exercise|Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.|2 weeks|Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.||||||
2598842|NCT02181127|Secondary|Fraction Measurements Within Each of the Following Glucose Ranges as Determined From HemoCue Measurements Taken Before Meals and Before Bed: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl|Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.|2 weeks|Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.||||||
2598843|NCT02181127|Secondary|Number of Study Days With Mean BG < 154 mg/dl||2 weeks||||number of days||Standard Deviation|Mean
2598844|NCT02181127|Secondary|Number of All BG Values Less Than 70 mg/dl||from t=0 to study stop after 2 weeks||||number of values||Standard Deviation|Mean
2598845|NCT02181127|Secondary|Percentage of the BG Values Taken Before Meals and Before Bedimte Less Than 70 mg/dl|Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.|2 weeks|Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.||||||
2598846|NCT02181127|Secondary|Average BG as Determined From the Measurements Taken Before Meals and Before Bedtime|Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.|2 weeks|Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.||||||
2598847|NCT02181127|Secondary|Number of Hypoglycemic Events (< 60 mg/dl) as Determined From BG Measurements||from t=0 to study stop after 2 weeks||||number of events||Standard Deviation|Mean
2598848|NCT02181127|Secondary|Mean Absolute Relative Deviation (MARD) Between Capillary Blood Glucose and CGM Glucose Values|Paired values between the blood glucose measurements and CGM glucose measurements were compared, and the percent difference was recorded. The mean of the absolute value of all the differences is reported here, and reflects the accuracy of the CGM glucose measurements relative to the capillary blood glucose measurements.|from t=0 to study stop after 2 weeks|This analysis is not broken down according to randomization, because it is intended to give context to the other CGM reported outcomes by reflecting the accuracy of the CGM.|||percent difference||Standard Deviation|Mean
2598849|NCT02181127|Secondary|Mean Absolute Relative Deviation (MARD) vs. Subset of BG Measurements Before Meals and at Bedtime|Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.|2 weeks|Blood sugar measurements were not specified as before meals and before bed during the study, so we are unable to calculate and report this outcome.||||||
2598850|NCT02181127|Secondary|Mean CGMG During Exercise|Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.|2 weeks|Times of exercise were not collected during the study, and therefore this outcome cannot be calculated.||||||
2598851|NCT02181127|Secondary|Count of Subjects With Mean CGMG < 154mg/dl||from t=0 to study stop after 2 weeks||||Participants|||Count of Participants
2598858|NCT02181075|Secondary|Patients With Significant (Grade 3-5) Adverse Event(s) Deemed Related to FUS Procedure|"Adverse Events are listed separately in the subsequent results, but were also specified as a secondary endpoint in the a priori protocol and thus significant events are summarised here.~'Definitely' or 'Probably' related events are included."|Up to 30 days post-intervention (Day 1-30)||||Participants|||Count of Participants
2598859|NCT02181075|Secondary|Patients With Significant (Grade 3-5) Adverse Event(s) Deemed Related to ThermoDox (LTLD)|"Adverse Events are listed separately in the subsequent results, but were also specified as a secondary endpoint in the a priori protocol and thus significant events are summarised here.~'Definitely' or 'Probably' related events are included."|Up to 30 days post-intervention (Day 1-30)||||Participants|||Count of Participants
2598860|NCT02181075|Secondary|Persistence of Cell Viability Stain Post-LTLD+FUS|"Post-LTLD+FUS tissue from the targeted liver tumours was obtained by biopsy at the time of the intervention, between 24/03/2015 and 29/03/2017. Cytokeratin-8 (CK-8) is a cell viability marker which if present, demonstrates lack of ablative cell death by any ablative modality, including FUS.~Not all histological cell types express CK8, thus if the Post-LTLD+FUS it may either indicate:~i) Non-CK8 expression ii) Thermal ablation and consequent cell death.~Note there was uncertainty about CK8 expression of individual patient tumours prior to recruitment. In this study if the Post-LTLD+FUS tissue shows specific cellular CK8 cellular staining, then it demonstrates that i) the tumour is CK8+, and, ii) the tumour was not instantaneously thermally ablated and any subsequent cell death is likely due to drug delivery/chemo-ablation.~For more information see key TARDOX Lancet Oncology publication and Cytokeratin 8 reference (both detailed in References section)."|Tissue obtained on day of intervention (Day 1). All CK8 cell viability staining was performed within 2 months of sampling.|5/6 Part I patients and 4/4 Part II patients had tissue which was analysable for CK-8. The Outcome Measure Data Table demonstrates the number of patients from each arm having CK-8 positive tumour biopsy samples post-LTLD+FUS, indicating lack of thermal ablation (which is consistent with desired hyperthermia rather than undesirable FUS ablation).|||Participants|||Count of Participants
2598861|NCT02181075|Secondary|(Part I Only) Achievement of Satisfactory Hyperthermia Within the Target Liver Tumour for a Range of Participant Body Mass Indices (BMIs) and Tumour Locations Within the Liver (Optimal FUS Exposure Parameters)|"Achievement of hyperthermia in the target liver tumour, as determined by real-time thermometry obtained by an indwelling thermometry device.~For success, sustained and controlled hyperthermia is required in the target tumour, consequent with drug release (in excess of 39.5^oC). Real time thermometry plots for each Part I patient are available in the key Lancet Oncology publication, details available in the References section."|Real-time thermometry monitoring during intervention (Day 1)|In Part II there was no real-time thermometry and this endpoint only applies to Part I patients.|||Participants|||Count of Participants
2598862|NCT02181075|Primary|Patients Demonstrating >Two-fold Increase in the Amount of Intratumoural Doxorubicin Before and After Focused Ultrasound|"To satisfy the primary endpoint, a demonstrable two-fold increase in*, or value exceeding 10μg/g of, the concentration of intra-tumoural doxorubicin at the treated tumour site following FUS-induced mild hyperthermia, was required in at least 50% of evaluable participants.~* As per the a priori protocol design, in Part II the biopsy prior to FUS-induced mild hyperthermia is not performed and therefore the average value for all evaluable tumours receiving intervention in Part I is used as a comparison for the two-fold increase from pre-FUS to post-FUS biopsy."|Post-LTLD+FUS sample (Day 1) compared to Post-LTLD sample (Day 1)||||Participants|||Count of Participants
2598863|NCT02181075|Primary|Concentration of Total Intratumoral Doxorubicin in Liver Tumour (Biopsies) Following Targeted Release of Doxorubicin From ThermoDox® ('Drug') Using Mild Hyperthermia Generated Non-invasively by Focused Ultrasound (FUS)|"Analytical chemistry (High Performance Liquid Chromatography) for total doxorubicin (including both released and unreleased forms) was performed on section of intratumoral biopsy samples in Good Clinical Practice Laboratory, using a validated assay.~Doxorubicin concentration was evaluated in biopsy samples both post-LTLD and post-LTLD+FUS.~Tumour samples were not analysed same day and were frozen at -80^oC for subsequent analysis. Required to evaluate the primary endpoint."|Post-intervention sample (Day 1) compared to pre-intervention sample (Day 1)||||ug/g of total doxorubicin(tumour biopsy)||Standard Deviation|Mean
2598864|NCT02180893|Secondary|Participant Satisfaction Score|Participants were asked to score their satisfaction with their postoperative pain control on a scale of 0 (least satisfied) to 10 (most satisfied)|48 hours||||units on a scale||Standard Deviation|Mean
2598865|NCT02180893|Secondary|Participant Satisfaction|Participants were asked whether or not they were satisfied with their postoperative pain control (yes or no)|48 hours||||"percentage of yes responders"|||Number
2598866|NCT02180893|Primary|Visual Analog Scale (VAS) Pain Scores|Possible scores range from 0-10, with 0 being no pain and 10 being highest level of pain|24 hours||||units on a scale||Standard Deviation|Mean
2598867|NCT02180893|Primary|Postoperative Fentanyl||24 hours||||microgram/kilogram||Standard Deviation|Mean
2598868|NCT02180828|Secondary|Total Adverse Events|Total adverse events(cases)|at day 7-14 follow up||||participants|||Number
2598869|NCT02180828|Secondary|Adverse Events 4|Skin sensitivity, urticaria rash, erythematous rash, irritation|at day 7-14 follow up||||participants|||Number
2598870|NCT02180828|Secondary|Adverse Events 3|Gastrointestinal tract: abdominal pain, diarrhoea, nausea|at day 7-14 follow up||||participants|||Number
2598871|NCT02180828|Secondary|Adverse Events 2|Vulvovaginal pruritus, burning, irritation, and bleeding|at day 7-14 follow up||||participants|||Number
2598872|NCT02180828|Secondary|Adverse Events 1|Systemic: weak, palpitation, tachycardia, migraine, headache, dizzy, rhinorrhea, numb, dizziness, fatigue.|at day 7-14 follow up||||participants|||Number
2598873|NCT02180828|Primary|Therapeutic Efficacy 4|Mycological cure of clotrimazole group and fluconazole group: Mycological cure or failure was referred to as Candida negative or positive,respectively, on Candida culture at follow-up visits.|at days30-35 follow-up||||participants|||Number
2598874|NCT02180828|Primary|Therapeutic Efficacy 3|Mycological cure of clotrimazole group and fluconazole group|at days 7-14 follow-up||||participants|||Number
2598875|NCT02180828|Primary|Therapeutic Efficacy 2|The clinical cure rates of clotrimazole and fluconazol|at days 30-35 follow-up||||participants|||Number
2608994|NCT02071290|Primary|Endothelial Injury (Syndecan-1)|Change in plasma levels of endothelial injury marker Syndecan-1 over 24 hours from Admission|0 (Admission), 1, 3, 24 hours||||ng/mL||Inter-Quartile Range|Median
2598876|NCT02180828|Primary|Therapeutic Efficacy 1|The clinical cure rates of clotrimazole and fluconazol: Clinical cure was defined as the resolution of symptoms present at baseline with a total severity score of ≤2. Improvement was defined as considerable reduction in the severity of baseline signs and symptoms with a decrease in the total score by ≥50%.Patients not clinically cured or showing improvement were considered clinical failures.|7-14 days after treatment (=visit 2)|PPS|||participants|||Number
2598877|NCT02180724|Secondary|Summary of Duration of Response (DOR)|DOR is defined as the interval from the first documentation of Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR) or Minor Response (MR) to the earlier of the first documentation of definitive PD or death from any cause. The summary statistics are provided for DOR.|Primary analysis occur when all subjects have completed Cycle 27 or have excit the study|200mg QD patients eventually switch to 100mg BID and will be summarized in the 100 mg Arm in the results|||month||Standard Deviation|Mean
2598878|NCT02180724|Secondary|Overall Survival (OS) of Acalabrutinib by Investigator|Kaplan-Meier (K-M) estimates of the OS assessments and its 95% confidence interval are provided using both 3rd and 6th IWWM criteria by investigator. K-M estimates at a certain time (ex. all subjects complete Cycle 27) provides the estimated percentage of the subjects who are still alive by the given time over all patients at risk.|Primary analysis occur when all subjects have completed Cycle 27 or have discontinued before Cycle 27.|200mg QD patients eventually switch to 100mg BID and will be summarized in the 100 mg Arm in the results|||Percentage of subjects||95% Confidence Interval|Number
2598879|NCT02180724|Secondary|Progression-free Survival (PFS) of Acalabrutinib by Investigator|Kaplan-Meier (K-M) estimates of the PFS assessments and its 95% confidence interval are provided using both modified 3rd and 6th IWWM criteria by investigator. K-M estimates at a certain time (ex. all subjects complete Cycle 27) provides the estimated percentage of the subjects who are still alive or have not progressed by the given time over all patients at risk. Per 6th IWWM criteria, the progressive disease is defined as >= 25% increase in serum IgM level with an absolute increase of at least 500 mg/dL from lowest nadir (requires confirmation on at least 2 consecutive measurements at least 4 weeks apart) and/or progression of clinical features attributable to the disease. Per modified 3rd IWWM criteria, besides IgM requirement as 6th criteria, it could also includes progression of clinically significant disease related symptoms and/or death from any cause or initiation of a new anti-neoplastic therapy.|Up to approximately 3.8 years. Data cut at last subject have completed Cycle 27 (28 days per Cycle).|200mg QD patients eventually switch to 100mg BID and will be summarized in the 100 mg Arm in the results|||percentage of subjects||95% Confidence Interval|Number
2598880|NCT02180724|Primary|Overall Response Rate (ORR) of Acalabrutinib in Subjects as Assessed by Investigator|ORR defined as the rate of subjects achieving a Miner Response (MR) or better including complete response (CR), very good partial response (VGPR), partial response (PR) and MR; The definition of responses are evaluated by investigators using both Modified 6th criteria (refer to protocol table 4-2 , 4-3) and Modified 3rd International Workshop of Waldenström Macroglobulinemia (IWWM) criteria (refer to protocol table 4-4 and table 4-5 for definition). For Modified 6th criteria, MR is defined as (1) monoclonal IgM protein is detectable, (2) no new signs or symptoms of active disease, (3) and patient has >=25% but < 50% reduction in serum monoclonal IgM level from baseline. PR and VGPR both require (1) and (2) as MR, but PR also requires the >=50% and <90% reduction in serum monoclonal IgM level as well as reduction in extramedullary disease. VGPR requires >= 90% reduction in serum IgM and complete resolution of extramedullary disease.|Up to approximately 3.8 years. Data cut at when last patient have completed Cycle 27 (28 days per Cycle).|200mg QD patients eventually switched to 100mg BID|||Participants|||Count of Participants
2598881|NCT02180659|Secondary|Measures of Craving: Need to Use Visual Analogue Scale (VAS)|The secondary outcome of measures of craving: Need to use is a change from Day 1 (baseline) in the unipolar visual analogue scale (VAS), which is a 0-100 mm scale, where 0 mm is no need, and 100 mm is strongest possible need.|24 weeks|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
2598882|NCT02180659|Secondary|Measures of Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) (ITT Population)|The secondary outcome measures the change in baseline in the subjective opioid withdrawal scale (SOWS), which is a scale which is a subject self-assessment of withdrawal symptoms. The scale consists of 16 questions that rate the intensity of withdrawal from 0 (not at all) to 4 (extremely) with a cumulative score ranging from 0-64 (0 =not at all, 64=extremely)|24 weeks|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
2598883|NCT02180659|Secondary|Measures of Withdrawal: Clinical Opiate Withdrawal Scale (COWS)|The secondary outcome measures the change in baseline in the Clinical opiate withdrawal scale (COWS), which is a scale consisting of 11 common opiate withdrawal signs or symptoms, rated on a numeric scale with higher scores associated with greater withdrawal symptoms. A total score was calculated as the sum of the responses to the 11 signs/symptoms for a total range of 0-48. Withdrawal severity was classified, based on the total score, as follows: 0-4=none/normal, 5-12=mild, 13-24=moderate, 25-36=moderately severe, more than 36=severe withdrawal.|24 weeks|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
2598884|NCT02180659|Secondary|Measures of Craving: Desire to Use Visual Analogue Scale (VAS)|The secondary outcome of measures of craving: desire to use is a change from Day 1 (baseline) in the unipolar visual analogue scale (VAS), which is a 0-100 mm scale, where 0 mm is no desire, and 100 mm is strongest possible desire.|24 weeks|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||units on a scale||Standard Deviation|Mean
2598885|NCT02180659|Secondary|Percent of Subjects With no Self-reported Illicit Drug Use by Month|Subjects in the ITT population with no self-reported use of any illicit drugs (opioid or non-opioid) by month of evaluation|24 weeks|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||Participants|||Count of Participants
2598886|NCT02180659|Secondary|Number of Participants With Evidence of Urine Illicit Opioid Use by Month|Secondary efficacy endpoint measures number of participants with evidence of urine illicit opioid use by month.|24 weeks|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||Participants|||Count of Participants
2598887|NCT02180659|Secondary|Percent of Subjects With no Urine Illicit Opioid Use by Month;|The secondary outcome is the percent of subjects with no urine illicit opioid use by month.|24 weeks|Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.|||Participants|||Count of Participants
2598888|NCT02180659|Primary|The Primary Efficacy Endpoint is a Responder Rate Analysis, Where a Responder is Defined as a Patient With no More Than 2 of 6 Months With Any Evidence of Illicit Opioid Use.|The primary efficacy endpoint is a responder analysis. A subject will be designated as a responder (meaning they have maintained stability) if they have no more than 2 of 6 months with any evidence of illicit opioid use. Evidence of illicit opioid use is defined as a positive opioid urine toxicology result or self-reported illicit opioid use.|24 weeks|The analyses included 173 subjects in the ITT population who received treatment and post-baseline evaluations.|||Participants|||Count of Participants
2598889|NCT02180646|Other Pre-specified|Post-meal Glucagon-like Peptide-1 (GLP-1) Level (AUC )|AUC for 4 hr after breakfast and after lunch|0-240 and 240-480||||ng/ml x min for 4 h||Standard Error|Mean
2598890|NCT02180646|Other Pre-specified|Post-meal Insulin Level (AUC [0-4])|AUC for 4 hr after breakfast and after lunch|0-240 and 240-480||||min*pg/ml||Standard Error|Mean
2598891|NCT02180646|Secondary|Post-meal Level of Glucose-dependent Insulinotropic Peptide (GIP) (AUC)|AUC for 4 hr after breakfast and after lunch|0-240 and 240-480||||min*pg/ml||Standard Error|Mean
2598892|NCT02180646|Primary|Plasma Glucose Level Post-meal (AUC [0-4])|AUC for 4 hr after breakfast and after lunch|0-240 and 240-480||||min*pg/ml||Standard Error|Mean
2598893|NCT02180438|Other Pre-specified|Interim Analysis at 24 Weeks of Grade 3 and 4 Adverse Events||24 weeks||||Participants|||Count of Participants
2598894|NCT02180438|Other Pre-specified|Interim Analysis at 24 Weeks of HIV-2 Virologic Failure|Virologic failure, FDA Snapshot (HIV-2 plasma viral load >50 and >400 copies/ml)|24 weeks||||Participants|||Count of Participants
2598895|NCT02180438|Other Pre-specified|Interim Analysis at 24 Weeks of New WHO Stage 3 or 4 Event||24 weeks||||Participants|||Count of Participants
2598896|NCT02180438|Other Pre-specified|Interim 24 Weeks Analysis of Death||24 weeks||||participants|||Number
2598897|NCT02180438|Secondary|Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF||48 weeks||||Participants|||Count of Participants
2598898|NCT02180438|Secondary|Switching Off Stribild Prior to 48 Weeks||48 Weeks||||Participants|||Count of Participants
2598899|NCT02180438|Secondary|< 50 CD4 T-cell Increase at 48 Weeks From Baseline||48 weeks||||Participants|||Count of Participants
2598900|NCT02180438|Secondary|CD4 T-cell Count at 48 Weeks < Baseline||48 weeks||||Participants|||Count of Participants
2598901|NCT02180438|Secondary|Grade 3 or 4 Adverse Events|Adverse event per NIH/DAIDS criteria|48 weeks||||Participants|||Count of Participants
2598902|NCT02180438|Primary|Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml)||48 weeks||||Participants|||Count of Participants
2598903|NCT02180438|Primary|New WHO Stage 3 or 4 Event|New AIDS defining event per WHO criteria|48 weeks||||Participants|||Count of Participants
2598904|NCT02180438|Primary|Death|Number of Participants Experiencing Death within the study period|48 weeks||||Participants|||Count of Participants
2598905|NCT02180230|Secondary|Cumulative Survival Rates of the Implants|An implant was reported to be a surviving implant when it remained in the jaw and was functionally loaded even if not all the individual success criteria were fulfilled (i) an implant that causes no allergic, toxic or gross infectious reactions either locally or systemically, ii) offered anchorage to a functional prosthesis, iii) showed no signs of fracture or bending, iv) showed no signs of peri-implant radiolucency on an intraoral radiograph using a paralleling technique strictly perpendicular to the implant-bone interface, and v) showed no mobility when individually tested by either tapping or rocking with a hand instrument).|implant insertion to follow-up visits (6, 12, 36 and 60 months)|Intention to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation.|||percentage of surviving implants|Participants||Number
2598906|NCT02180230|Primary|Marginal Bone Remodeling|"Marginal bone remodeling is calculated for each side of the implant (mesial and distal) separately, as the difference between bone levels at two time points. The average of mesial and distal remodeling is then calculated for each implant site (paired for each side between two different points). Negative numbers indicate bone loss. Implant insertion was defined as a baseline.~Missing data was not imputed and not included in evaluation."|from implant insertion to 6, 12, 36 and 60 months|Intention to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation.|||mm|Participants|Standard Deviation|Mean
2598907|NCT02180165|Secondary|Percentage of Participants With Chronic Pulmonary Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 84|A mycological response of eradication is defined as fungus detected from culture or microscopy at the screening is eradicated at the time of evaluation (including presumed eradication), as assessed by the CAC.|Day 84|Participants in cohort 2 diagnosed by CAC with proven or probable chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.|||Percentage of participants|||Number
2598908|NCT02180165|Secondary|Percentage of Participants With Chronic Pulmonary Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 42|A mycological response of eradication is defined as fungus detected from culture or microscopy at the screening is eradicated at the time of evaluation (including presumed eradication), as assessed by the CAC.|Day 42|Participants in cohort 2 diagnosed by CAC with proven or probable chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.|||Percentage of participants|||Number
2598909|NCT02180165|Secondary|Percentage of Participants With Chronic Pulmonary Aspergillosis With Radiological Response of Resolution in Cohort 2 at Day 42|A radiological response of resolution is defined as resolution of radiological lesions, as assessed by the CAC.|Day 42|Participants in cohort 2 diagnosed by CAC with proven or probable chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.|||Percentage of participants|||Number
2598910|NCT02180165|Secondary|Percentage of Participants With Chronic Pulmonary Aspergillosis With Clinical Response of Resolution in Cohort 2 at Day 84|A clinical response of resolution is defined as resolution of attributable signs and symptoms of disease, as assessed by the CAC.|Day 84|Participants in cohort 2 diagnosed by CAC with proven or probable chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.|||Percentage of participants|||Number
2598911|NCT02180165|Secondary|Percentage of Participants With Chronic Pulmonary Aspergillosis With Clinical Response of Resolution in Cohort 2 at Day 42|A clinical response of resolution is defined as resolution of attributable signs and symptoms of disease, as assessed by the CAC.|Day 42|Participants in cohort 2 diagnosed by CAC with proven or probable chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.|||Percentage of participants|||Number
2598912|NCT02180165|Secondary|Percentage of Participants With Invasive Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 42|A mycological response of eradication is defined as fungus detected from culture or microscopy at the screening is eradicated at the time of evaluation (including presumed eradication), as assessed by the CAC.|Day 42|Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.|||Percentage of participants|||Number
2598913|NCT02180165|Secondary|Percentage of Participants With Invasive Aspergillosis With Radiological Response of Resolution or Improvement in Cohort 2 at Day 84|A radiological response of resolution is defined as resolution of radiological lesions, and a radiological response of improvement is defined as major reduction in size of radiological lesions as assessed by the CAC.|Day 84|Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.|||Percentage of participants|||Number
2598914|NCT02180165|Secondary|Percentage of Participants With Invasive Aspergillosis With Radiological Response of Resolution or Improvement in Cohort 2 at Day 42|A radiological response of resolution is defined as resolution of radiological lesions, and a radiological response of improvement is defined as major reduction in size of radiological lesions as assessed by the CAC.|Day 42|Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.|||Percentage of participants|||Number
2598915|NCT02180165|Secondary|Percentage of Participants With Invasive Aspergillosis With Clinical Response of Resolution or Improvement in Cohort 2 at Day 84|A clinical response of resolution is defined as resolution of attributable signs and symptoms of disease, and a clinical response of improvement is defined as improvement of attributable signs and symptoms of disease as assessed by the CAC.|Day 84|Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.|||Percentage of participants|||Number
2598916|NCT02180165|Secondary|Percentage of Participants With Invasive Aspergillosis With Clinical Response of Resolution or Improvement in Cohort 2 at Day 42|A clinical response of resolution is defined as resolution of attributable signs and symptoms of disease, and a clinical response of improvement is defined as improvement of attributable signs and symptoms of disease as assessed by the CAC.|Day 42|Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.|||Percentage of participants|||Number
2598917|NCT02180165|Secondary|Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 84 as Assessed by the Clinical Investigator|Successful treatment (or successful overall response) for chronic pulmonary aspergillosis is defined as favorable response to treatment assessed by the clinical investigator.The 95% CI is based on the Clopper-Pearson exact method.|Day 84|Participants in cohort 2 diagnosed by CAC with proven or probable chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2598918|NCT02180165|Secondary|Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42 as Assessed by the Clinical Investigator|Successful treatment (or successful overall response) for invasive aspergillosis is defined as complete response and partial response to treatment assessed by the clinical investigator.The 95% CI is based on the Clopper-Pearson exact method.|Day 42|Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2598919|NCT02180165|Secondary|Percentage of Participants With Successful Overall Response for Zygomycosis in Cohort 2 at Day 84|Zygomycosis is an infection caused by zygomycete fungi. Successful treatment (or successful overall response) is defined as complete response and partial response to treatment assessed by CAC. The 95% CI is based on the Clopper-Pearson exact method.|Day 84|Participants in cohort 2, posaconazole treatment only, diagnosed by CAC with proven or probable zygomycosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1, and cohort 2 voriconazole treatment were not analyzed for this outcome measure.|||Percentage of participants|||Number
2598939|NCT02179918|Secondary|Pre-dose Concentration During Multiple Dosing (Ctrough) of MK-3475|MK-3475 pre-dose concentration during multiple dosing|During Cycle 5 Day 1 at pre-dose; and end of infusion.|The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2616728|NCT01987609|Other Pre-specified|Adverse Events|Any adverse events that subjects have during the course of the study will be recorded at each visit.|1 week|||||||
2598920|NCT02180165|Secondary|Percentage of Participants With Successful Overall Response for Zygomycosis in Cohort 2 at Day 42|Zygomycosis is an infection caused by zygomycete fungi. Successful treatment (or successful overall response) is defined as complete response and partial response to treatment assessed by CAC. The 95% CI is based on the Clopper-Pearson exact method.|Day 42|Participants in cohort 2, posaconazole treatment only, diagnosed by CAC with proven or probable zygomycosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1, and cohort 2 voriconazole treatment were not analyzed for this outcome measure.|||Percentage of participants|||Number
2598921|NCT02180165|Secondary|Percentage of Participants With Successful Overall Response for Invasive Aspergillosis and Chronic Pulmonary Aspergillosis in Cohort 2 at End of Trial (Day 84)|Successful treatment (or successful overall response) for invasive aspergillosis is defined as complete response and partial response to treatment assessed by CAC. Successful treatment (or successful overall response) for chronic pulmonary aspergillosis is defined as favorable response to treatment.The 95% CI is based on the Clopper-Pearson exact method.|Day 84|Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis or chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2598922|NCT02180165|Secondary|Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 84|Successful treatment (or successful overall response) is defined as favorable response to treatment assessed by CAC. The 95% CI is based on the Clopper-Pearson exact method.|Day 84|Participants in cohort 2 diagnosed by CAC with proven or probable chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2598923|NCT02180165|Secondary|Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 42|Successful treatment (or successful overall response) is defined as favorable response to treatment assessed by CAC. The 95% CI is based on the Clopper-Pearson exact method.|Day 42|Participants in cohort 2 diagnosed by CAC with proven or probable chronic pulmonary aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2598924|NCT02180165|Secondary|Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 84|Successful treatment (or successful overall response) is defined as complete response and partial response to treatment assessed by CAC. The 95% CI is based on the Clopper-Pearson exact method.|Day 84|Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2598925|NCT02180165|Secondary|Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42|Successful treatment (or successful overall response) is defined as complete response and partial response to treatment assessed by the clinical adjudication committee (CAC). The 95% confidence interval (CI) is based on the Clopper-Pearson exact method.|Day 42|Participants in cohort 2 diagnosed by CAC with proven or probable invasive aspergillosis; who received at least one dose of study treatment; and had a baseline observation for the analysis endpoint. Participants in cohort 1 were not analyzed for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2598926|NCT02180165|Primary|Number of Participants With an Adverse Event|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product is also an AE.|Up to approximately Day 98|Cohort 1: All randomized participants with chronic pulmonary aspergillosis who received at least one dose of study treatment. Cohort 2: All randomized participants with invasive aspergillosis and chronic pulmonary aspergillosis who received at least one dose of study treatment.|||Participants|||Count of Participants
2598927|NCT02180061|Secondary|ORR Per Central Radiology Review Using Immune-related Response Criteria (irRC)|The ORR, using irRC, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (irCR; complete disappearance of all tumor lesions, whether measureable or not, and no new lesions) or a Partial Response (irPR; decrease in sum of the products of the 2 largest perpendicular diameters of 50% or greater) at any time during the study, based on central radiology review.|Up to 24 months|The FAS population consisted of all allocated participants who had irRC measurable lesions at the Baseline scan as assessed by central radiology review and received at least one dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
2598928|NCT02180061|Secondary|ORR Per Investigator Assessment Using RECIST 1.1|The ORR, using RECIST 1.1 criteria, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on Investigator assessment.|Up to 24 months|The FAS population consisted of all allocated participants who had measurable lesions at the Baseline scan as assessed by Investigator review and received at least one dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
2598940|NCT02179918|Secondary|Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566|PF-05082566 pre-dose concentration during multiple dosing|During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.|The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2598929|NCT02180061|Primary|Overall Response Rate (ORR) Per Central Radiology Review Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|The ORR, using RECIST 1.1, was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) at any time during the study, based on central radiology review.|Up to 24 months|The Full Analysis Set (FAS) population consisted of all allocated participants who had measurable lesions at the Baseline scan as assessed by central radiology review and received at least one dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
2598930|NCT02180061|Primary|Number of Participants Discontinuing Treatment Due to AEs|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|Up to last dose of study drug (Up to 24 months)|The APaT population consisted of all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2598931|NCT02180061|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.|All AEs: Up to 30 days after last dose of study drug; Serious AEs: Up to 90 days after last dose of study drug (Up to 27 months)|The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2598932|NCT02179918|Secondary|Number of Participants With Objective Tumor Response|Objective response (OR) was defined as complete response (CR) or partial response (PR) according to RECIST version 1.1 from the date of first dose of study treatment until documented disease progression.CR = at least 2 determinations of CR at least 4 weeks apart and before progression; PR = at least 2 determinations of PR or better at least 4 weeks apart and before progression (and not qualifying for a CR); Progression of disease (PD) = progression<=12 weeks after the date of first dose of study treatment (and not qualifying for CR, PR, SD or non-CR/non-PD); Stable disease (SD) (applicable only to participants with measurable disease at baseline) = at least 1 SD assessment (or better)>=6 weeks after the date of first dose of study treatment and before progression (and not qualifying for CR or PR). Both CR and PR were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met.|Baseline, at Week 9, and then every 6 weeks up to 90 days after the last dose of study drug, approximately 27 months. For those patients who achieved a confirmed PR or CR, tumor assessments could be conducted as clinically indicated.|The full analysis set (FAS) included all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than 1 treatment the participant was classified according to the first treatment received.|||Participants|||Number
2598933|NCT02179918|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA) of MK-3475|ADA blood samples were assayed for anti-MK-3475 antibodies using a validated analytical method in compliance with Merck (anti-MK-3475) SOPs.|Pre-dose in Cycles 1, 3, 5, 7 and subsequently pre dose every 2 cycles up to Cycle 12 and every 4 cycles thereafter and 28 days, and during follow-up (3 months and 6 months after the end of MK-3475 treatment).|The immunogenicity analysis set was a subset of the safety analysis set and included participants who have at least 1 ADA sample collected for either PF-05082566 or MK 3475.|||Participants|||Number
2598934|NCT02179918|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566|ADA blood samples were assayed for anti-PF-05082566 antibodies using a validated analytical method in compliance with Pfizer (anti-PF-05082566) standard operating procedures (SOPs). ADA data was listed and summarized for PF 05082566 by dose. Negative ADA: titer<6.23; Positive ADA: titer>=6.23.Treatment-induced ADA = ADA developed de novo (seroconversion) following biologic drug administration. Treatment-boosted ADA = pre-existing ADA that were boosted to a higher level following biologic drug administration.|Pre-dose (Day 1), Cycles 1, 3, 5, 7, and subsequently pre-dose (Day 1) every 2 cycles up to Cycle 12, and every 4 cycles thereafter|The immunogenicity analysis set was a subset of the safety analysis set and included participants who have at least 1 ADA sample collected for either PF-05082566 or MK 3475.|||Participants|||Number
2598935|NCT02179918|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to Time Tau, the Dosing Interval, Where Tau = 504 Hours (21 Days) [AUCtau] for PF-05082566|PF-05082566 area under the serum concentration-time curve (AUC) from time 0 to time tau, the dosing interval, where tau = 504 hours (21 days) (AUCtau)|During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.|The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.|||µg•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2598936|NCT02179918|Secondary|Volume of Distribution at Steady State (Vss) of PF-05082566|PF-05082566 volume of distribution at steady state|During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.|The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
2598937|NCT02179918|Secondary|Clearance (CL) of Study Drug of PF-05082566|Clearance of PF-05082566|During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.|The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.|||mL/hr/kg||Geometric Coefficient of Variation|Geometric Mean
2598938|NCT02179918|Secondary|Terminal Half-life （t½）of PF-05082566|PF-05082566 terminal half-life|During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.|The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.|||hour||Standard Deviation|Mean
2599363|NCT02175212|Secondary|Overall Survival: Estimated Percentage of Participants Alive at 5 Years|Overall Survival: defined as the time that elapses from the patient enters the study until the patient dies from any cause.|5 years||||percentage of patients||95% Confidence Interval|Number
2598941|NCT02179918|Secondary|Time for Cmax (Tmax) of PF-05082566|Time to reach PF-05082566 maximum observed serum concentration.|During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.|The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.|||hour||Full Range|Median
2598942|NCT02179918|Secondary|Maximum Observed Serum Concentration (Cmax) of MK-3475|Maximum MK-3475 observed serum concentration.|During Cycle 5 Day 1 at pre-dose; and end of infusion.|The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2598943|NCT02179918|Secondary|Maximum Observed Serum Concentration (Cmax) of PF-05082566|Maximum PF-05082566 observed serum concentration.|During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion|The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2598944|NCT02179918|Secondary|Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study|The ECOG shift from baseline to highest score during the on-treatment period was summarized by treatment group.ECOG Performance Status included 0, 1, 2, 3, and 4 grades. Grade 1 was Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature. Grade 2 was Ambulatory and capable of all self care but unable to carry out any work activities.Up and about more than 50% of waking hours. Grade 3 was capable of only limited self care, confined to bed or chair more than 50% of waking hours. Grade 4 was completely disabled. Cannot carry on any self care. Totally confined to bed or chair.|Baseline up to 28 days after the last dose of study drug, approximately 25 months|The safety analysis set included all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than 1 study treatment, the participant was classified according to the first treatment received.|||Participants|||Number
2598945|NCT02179918|Secondary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern|Vital sign summaries included all vital sign assessments from the on-treatment period. All vital sign parameters including blood pressure (BP) and weight were summarized using actual values and changes from baseline for each visit over time. The changes computed were the differences from baseline. The participants meeting criteria of potential clinical concern were judged by investigator.|Baseline up to 28 days after the last dose of study drug, approximately 25 months|The safety analysis set included all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than 1 study treatment, the participant was classified according to the first treatment received.|||Participants|||Number
2598946|NCT02179918|Secondary|Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries)|The chemical laboratory test included: sodium, potassium, total calcium, creatinine, albumin, alanine aminotransferase, alanine aminotransferase, glucose, phosphorus, magnesium, total bilirubin, blood urea nitrogen, alkaline phosphatase, lactate dehydrogenase, immunoglobulin G, total protein, uric acid, thyroid function assessments, hepatitis B and C tests. Laboratory results were categorical summarized according to the NCI-CTCAE criteria version 4.03. The total number of participants with chemistry laboratory test was assessed.|Baseline up to 28 days after the last dose of study drug, approximately 25 months|The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.|||Participants|||Number
2598947|NCT02179918|Secondary|Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology)|The hematology laboratory test included: absolute neutrophil count, hemoglobin, platelet count, white blood cell with differential, coagulation panel, urinalysis and pregnancy test. Laboratory results were categorical summarized according to the NCI-CTCAE criteria version 4.03. The total number of participants with hematology laboratory test was assessed.|Baseline up to 28 days after the last dose of study drug, approximately 25 months|The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.|||Participants|||Number
2598948|NCT02179918|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related)|An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.|Baseline up to 90 days after the last dose of study drug, approximately 27 months|The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.|||Participants|||Number
2598959|NCT02179671|Secondary|Progression-free Survival|Progression-free survival (per RECIST 1.1 as assessed by Investigator) is defined as the date of 1st dose of MEDI4736 until the date of objective disease progression or death. Progression of disease (PD) At least a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Up to 2 years|Per the analysis plan, efficacy would not be analyzed for treatment groups that did not have a sufficient number of enrolled patients.|||patients|||Number
2598949|NCT02179918|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related)|An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.|Baseline up to 90 days after the last dose of study drug, approximately 27 months|The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.|||Participants|||Number
2598950|NCT02179918|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related)|An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.|Baseline up to 90 days after the last dose of study drug, approximately 27 months|The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.|||Participants|||Number
2598951|NCT02179918|Secondary|Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities)|An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by National Cancer Institute (NCI) CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.|Baseline up to 90 days after the last dose of study drug, approximately 27 months|The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.|||Participants|||Number
2598952|NCT02179918|Primary|Number of Participants With Dose-Limiting Toxicities (DLT) of PF-05082566 in Combination With MK-3475|Severity of adverse events (AEs) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs occurring during the DLT observation period that were attributable to one or both study drugs were classified as DLTs. 1) Hematologic: Grade 4 neutropenia; Febrile neutropenia, defined as absolute neutrophil count (ANC) <1000/mm3 with a single temperature of >38.3C(101F) or a sustained temperature of 38C (100.4F) for more than 1 hour; Grade>=3 neutropenic infection; Grade>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia. 2) Non hematologic: Grade>=3 toxicities (non-laboratory); Grade>=3 nausea, vomiting or diarrhea despite maximal medical therapy; Grade 4 aspartate aminotransferase (AST) and alanine aminotransferase (ALT). 3) Other (non-AST/ALT) non-hematologic Grade>=3 laboratory value. 4) Inability to complete 2 infusions of MK-3475 and PF-05082566 during the DLT observation period.|First 2 cycles of treatment up to 24 months|The DLT evaluable set was a subset of the safety analysis set and included all participants who were eligible, received both study treatments and who either experienced a DLT during the first 2 cycles of PF-05082566 or completed the 2 cycles’ DLT observation period.|||Participants|||Number
2598953|NCT02179892|Secondary|Mean Time of First Opioid Use|The time of first opioid use after surgery will be recorded for up to 72 hours.|Post-surgery (Up to 72 Hours)||||hours||Standard Deviation|Mean
2598954|NCT02179892|Secondary|Mean Visual Analogue Scale (VAS) Pain Score With Movement|The VAS method of pain assessment (scale of 1-10) will be used to measure the patient's level of pain with movement each day during the 72 hour post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain.|Post-Surgery 24 Hours, 48 Hours, 72 Hours||||units on a scale||Standard Deviation|Mean
2598955|NCT02179892|Secondary|Mean Visual Analogue Scale (VAS) Pain Score at Rest|The VAS method of pain assessment (scale of 1- 10) will be used to measure the participant's pain level at rest each day during the 72 hours post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain.|Post-Surgery 24 Hours, 48 Hours, 72 Hours||||units on a scale||Standard Deviation|Mean
2598956|NCT02179892|Primary|Mean Opioid Consumption|The investigators will collect the total amount of opioid consumption for the 72 hour post operative period in each group.|Post Surgery (Up to 72 Hours)||||milligrams||Standard Deviation|Mean
2598957|NCT02179671|Secondary|Overall Survival|To assess the efficacy of various sequences. In survival follow up at data cut off.|Up to 2 years|Per the analysis plan, efficacy would not be analyzed for treatment groups that did not have a sufficient number of enrolled patients.|||patients|||Number
2598958|NCT02179671|Secondary|Duration of Response|Duration of response (DoR; per RECIST 1.1 as assessed by the site Investigator) will be defined as the time from the date of 1st documented response (which is subsequently confirmed) until the 1st date of documented progression or death in the absence of disease progression.|Within 12 months|Per the analysis plan, efficacy would not be analyzed for treatment groups that did not have a sufficient number of enrolled patients. Response was observed for 1 patient in the Tremelimumab 1-cycle arm for up to and including 6 months.|||Months||Inter-Quartile Range|Median
2600100|NCT02167074|Secondary|Presence of Vital Target Cells Per Case, Per Needle Type|Presence of sufficient vital target cells, as in, target organ cells to provide a diagnosis (yes or no)|after 27 months||||Participants|||Count of Participants
2598960|NCT02179671|Secondary|Objective Response Rate (ORR)|To further assess the efficacy of various sequences. Objective response rate (ORR; per RECIST 1.1 as assessed by the site Investigator) is defined as the number (%) of patients with a confirmed overall response of CR or PR and was based on the evaluable analysis set. Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 2 years|Per the analysis plan, efficacy would not be analyzed for treatment groups that did not have a sufficient number of enrolled patients.|||patients (%)||80% Confidence Interval|Number
2598961|NCT02179671|Primary|Confirmed Complete Response (CR) Rate|To assess the efficacy of various sequences. CR (per RECIST 1.1 as assessed by the local/site Investigator) is defined as the disappearance of all target and non-target lesions. Confirmed complete response rate (CR rate) is defined as the number (%) of patients with a confirmed overall response of CR and was based on the evaluable analysis set.|Up to 2 years|Per the analysis plan, efficacy would not be analyzed for treatment groups that did not have a sufficient number of enrolled patients.|||patients (%)||80% Confidence Interval|Number
2598962|NCT02179424|Secondary|Smoking Reduction|Reduced at least 50% of cigarette consumption|6 month follow-up and 12 month follow-up||||participants|||Number
2598963|NCT02179424|Primary|Smoking Quit Rate|smoking quit rate was defined as the self-reported 7-day point prevalence abstinence|6 month follow-up and 12 month follow-up|In Phase 2, a sample of 642 employees enrolled in the study and chose 1 among the 4 conditions for smoking cessation.|||participants|||Number
2598964|NCT02179424|Primary|Employers' KAP|"A questionnaire aimed to examine the employers'/ managerial staff's knowledge, attitudes and practices in promoting smoking cessation in the workplace.~The questionnaires consist of three parts:~Employers's knowledge was assessed by measuring the average number of correct answers on questions about smoking and quitting (Scale 1-7).~Employers' attitude was assessed by measuring the average number agreeing items about their willingness to support employees to quit which included implementation of measures to show support for smoking cessation in the workplace or participation in smoking cessation programme (Scale 1-17).~Employers' practice was assessed by the level of smoking ban in the workplace as reported by the employer. (Scale 1-4; 1: not prohibited, 2: prohibited by not strictly, 3: Strictly prohibited and 4: absolutely strictly prohibited)."|Before the health talk|In Phase 1, questionnaires were sent out to 580 companies and 292 of the company employers returned the complete questionnaire. These 292 employers were not participating in the Phase 2 of this study.|||units on a scale||Standard Deviation|Mean
2598965|NCT02179398|Secondary|Specificity of Standard Biological Marker for SBI|Specificity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1'500/mm³ and/or CRP ≥ 40 mg/L|at 72 hours from PED presentation||||percentage of patients (specificity)||95% Confidence Interval|Number
2598966|NCT02179398|Secondary|Sensitivity of Standard Biological Marker for SBI|Sensitivity of standard biological marker for SBI: WBC ≥ 15'000/mm³ and/or bands ≥ 1'500/mm³ and/or CRP ≥ 40 mg/L|at 72 hours from PED presentation||||percentage of patients (sensitivity)||95% Confidence Interval|Number
2598967|NCT02179398|Secondary|Specificity of a Lab-score ≥ 3||at 72 hours from PED presentation||||percentage of patients (specificity)||95% Confidence Interval|Number
2598968|NCT02179398|Secondary|Sensitivity of a Lab-score ≥ 3||at 72 hours from PED presentation||||percentage of patients (sensitivity)||95% Confidence Interval|Number
2598969|NCT02179398|Secondary|Hospitalization Rate||at PED presentation||||participants|||Number
2598970|NCT02179398|Secondary|Presence of Serious Bacterial Infection||at 72 hours from PED presentation||||participants|||Number
2598971|NCT02179398|Primary|Antibiotic Prescription Rate||at PED (Pediatric Emergency Department) presentation|children 7 days – 36 months old presenting to the PED with fever without source (FWS) ≥38.0°C (≥ 100.4°F) after a thorough history and careful examination|||participants|||Number
2598972|NCT02179190|Other Pre-specified|Number of Participants With Reported Device Related Serious Adverse Events|This secondary outcome measure provides the count of participants reported with a Serious Device Related Adverse Events|From the point of consent until participant exits the study at 1 year|Subjects with an Attempted Barrel VRD Implant|||Participants|||Count of Participants
2598973|NCT02179190|Secondary|Number of Participants With Any Cause of Death Within 30 Days or Neurological Death Within 12 Months +/- 8 Weeks|This secondary outcome measure provides the combined number and percentage of subjects that died within 30 days or had a neurologic death within 12 months of receiving the study device.|30 Days and 12 months +/- 8 weeks||||Participants|||Count of Participants
2598974|NCT02179190|Secondary|Number of Participants With Angiographic Evidence of In-stent Stenosis at 12 Months +/- 8 Weeks Reported According to the Following Ordinal Groups: <25%, 25-50%, 51-75%, >75%|This secondary measure provides the count of participants with parent artery stenosis per an independent core lab evaluation within the following ordinal groups: <25%, 25-50%, 51-75%, >75%.|At 12 Months +/- 8 weeks|Outcomes are based on observed data on 89 participants with evaluable angiographic data at 1 year. 38/127 participants did not have angiographic data at 1 year available for analysis.|||Participants|||Count of Participants
2598975|NCT02179190|Secondary|Number of Participants With Modified Rankin Score of 0-2 or no Change From Baseline|"This secondary outcome provides the count of participants treated with the Barrel device with a Modified Rankin Score of 0-2 at 12 months or no change from baseline.~The Modified Rankin Score is a scale for measuring general functionality as follows:~0: No symptoms at all~No significant disability despite symptoms; able to carry out all usual duties and activities~Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance~Moderate disability; requiring some help, but able to walk without assistance~Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance~Severe disability; bedridden, incontinent and requiring constant nursing care and attention~Dead"|12 months, after device implant|Outcomes are based on observed data, from 111 participants completed at 1-year and 3 participants with an mRS score of 6 (death) prior to 1 year.|||Participants|||Count of Participants
2599009|NCT02178800|Secondary|Number of Injectable Hormonal-contraception-using Female Participants Who Discontinue Study Product for Reasons of Toxicity, Tolerability, or Acceptability During Oral Phase|Stratified by arm|Measured through Week 4|This population includes injectable hormonal-contraception-using female participants in the study|||Participants|||Count of Participants
2598976|NCT02179190|Secondary|Number of Participants With Raymond Grade I (100% Complete Occlusion) and Raymond Grade II (Residual Neck) for Participants Treated With the Barrel VRD, in the Absence of Retreatment, Parent Artery Stenosis (>50%), or Target Aneurysm Rupture at 12 Months|"This secondary outcome measure provides the count of participants treated with the Barrel VRD with Independent Core Laboratory aneurysm occlusion imaging evaluations of Complete Occlusion (Raymond Grade I) and Residual Aneurysm Neck (Raymond Grade II) at 12 months combined. Subjects with evidence of parent artery stenosis, retreatment, or rupture were not considered success.~Raymond Grade Scale~Class 1: Complete occlusion - complete obliteration of the aneurysm. Class 2: Residual neck - persistence of any portion of the original defect of the arterial wall as seen on any single projection, but without opacification of the aneurysmal sac.~Class 3: Residual aneurysm - opacification of the aneurysmal sac."|12 months, after device implant|Outcomes are based on observed data (i.e., 106 participants with 12-month evaluable imaging). 21/127 participants did not have evaluable imaging at 1-Year.|||Participants|||Count of Participants
2598977|NCT02179190|Secondary|Number of Participants With Successfully Deployed Barrel VRD|This secondary outcome measure provides the number of subjects successfully implanted with the Barrel VRD.|Index Procedure, Day 0||||Participants|||Count of Participants
2598978|NCT02179190|Primary|Number of Participants With Raymond Grade I ( 100%) Occlusion of the Aneurysms for Participants Treated With the Barrel VRD at 12 Months in the Absence of Retreatment, Parent Artery Stenosis, or Target Aneurysm Rupture|"The primary effectiveness endpoint was the count of participants achieving Raymond Grade I (100% occlusion) of the aneurysm treated with the Barrel VRD at 12 months ± 8 weeks in the absence of retreatment, parent artery stenosis (>50%), or target aneurysm rupture~The Raymond Grade Classification definitions evaluated by an independent core laboratory are as follows:~Class 1: Complete occlusion - complete obliteration of the aneurysm. Class 2: Residual neck - persistence of any portion of the original defect of the arterial wall as seen on any single projection, but without opacification of the aneurysmal sac.~Class 3: Residual aneurysm - opacification of the aneurysmal sac"|12 months, after device implant|Subjects treated with the Barrel VRD that completed the 12 month visit imaging|||Participants|||Count of Participants
2598979|NCT02179190|Primary|Number of Participants With Neurologic Death or Major Ipsilateral Stroke Within 12 Month Follow-up Period.|"The primary safety endpoint was the number of participants reported with a neurological death or major ipsilateral stroke (National Institute of Stroke Scale (NIHSS) increase of ≥ 4 for > 24 hours) at any time during the follow-up period.~The NIHSS is a tool used to quantify neurological impairment caused by stroke. The scale interpretation is as follows:~0: No stroke symptoms 1-4: Minor stroke symptoms 5-15: Moderate stroke 16-20: Moderate to severe stroke 21-42: Severe strokeThe National Institutes of Health Stroke Scale"|12 months, after device implant|Participants implanted with the Barrel VRD|||Participants|||Count of Participants
2598980|NCT02179177|Secondary|Number of Hospitalizations During Treatment||up to 8 months|Two participants from each group (Apixaban and Placebo) did not return for 8 Month visit.|||hospitalizations||Standard Deviation|Mean
2598981|NCT02179177|Secondary|Daily Pain Scores While Hospitalized as Measured by VAS|"The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with 0 corresponding to no pain at one end and 10 indicating the worst pain at the other. Secondary analysis will be performed to evaluate differences when patients are hospitalized and on study drug versus placebo."|up to 8 months|Two participants from each group (Apixaban and Placebo) did not return for Month 8 visit.|||score on a scale||Standard Deviation|Mean
2598982|NCT02179177|Secondary|Change in Thrombin Generation Using D-dimer Measurement as a Surrogate||Enrollment to 2 months|Data not collected.||||||
2598983|NCT02179177|Primary|Change in Pain as Measured by Visual Analog Scale (VAS)|"The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with 0 corresponding to no pain at one end and 10 indicating the worst pain at the other."|Month 1 to Month 8|Two participants in each group (Apixaban and Placebo) did not return for Month 8 visit.|||score on a scale||Standard Deviation|Mean
2598984|NCT02179047|Primary|SYNTAX(SYNergy Between Percutaneous Coronary Intervention With TAXus) for Stable Angina Receveived Coronary Angiogram|"The relationship of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2) with SYNTAX score.~The SYNTAX Score is a unique tool to score complexity of coronary artery disease; there is no theoretical range existed for the SYNTAX score.~Low risk:<22; intermediate risk: 22-33, high risk:>33"|6-12 months|"The SYNTAX Score is a unique tool to score complexity of coronary artery disease; there is no theoretical range existed for the SYNTAX score.~SYNTAX Web site: http://www.syntaxscore.com/index.php Low risk:<22; intermediate risk: 22-33, high risk:>33"|||scores on a scale|lesions|Standard Deviation|Mean
2598985|NCT02179047|Primary|Biomarker of Healthy Subjects(Placebo)|The relationship of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2) of healthy subjects(placebo).|6-12 months||||tilter|lesions|95% Confidence Interval|Geometric Mean
2598986|NCT02179047|Primary|Biomarker Titer of Patients With Coronary Artery Disease|The titer of 6 biomarkers(NGAL,Cystatin C,Galectin-3,Copeptin,MR-Pro ANP,sST2).|6-12 months||||tilter|lesions|95% Confidence Interval|Geometric Mean
2598987|NCT02178995|Post-Hoc|Hit Reaction Time (Open-Label)|"Hit reaction time represents the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~This was not a pre-specified variable or an intentional post-hoc analysis, but it is calculated automatically and included here only for completeness of data submission."|Visits 2 vs 3 vs 4 on randomized medication doses.||||Milliseconds||Standard Deviation|Mean
2598988|NCT02178995|Post-Hoc|Hit Reaction Time (Double Blind)|"Hit reaction time represents the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~This was not a pre-specified variable or an intentional post-hoc analysis, but it is calculated automatically and included here only for completeness of data submission."|Visits 2 vs 3 vs 4 on randomized medication doses.||||ms||Standard Deviation|Mean
2599025|NCT02178722|Secondary|Phase 2: Duration of Disease Control|The duration of disease control is the time from the treatment start date to the first objective response of PD (by irRECIST v1.1 or Lugano Classification Cheson et al 2014), death, or last tumor assessment date (if PD/death not present), for subjects with best overall response of SD or bette|Assessed every 9 weeks for duration of study participation which is estimated to be a minimum of 18 weeks|||||||
2598989|NCT02178995|Post-Hoc|Remaining CPT Variables (Double-blind Portion)|"Remaining CPT variables are automatically calculated by the program. They were not pre-specified variables of interest nor intentional post-hoc analyses. They are included ONLY for completeness of data submission.~Hit reaction time represents to the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~Variability refers to variations in response time across individual blocks of time within the trial. It differs from HRTSD in that HRTSD measures variability across the entire trial. Minimum is 0. There are no absolute maximums. A higher score is WORSE.~Perseverations are errors made either faster than physiologically possible (<100ms). Minimum is 0, there is no maximum. Higher scores are WORSE."|Placebo vs 10mg vs 20mg (visits 2, 3, 4)||||Units||Standard Deviation|Mean
2598990|NCT02178995|Post-Hoc|Remaining CPT Variables (Open-label)|"These are automatically-calculated CPT variables which were not pre-specified variables of interest or intentional post-hoc analyses. They are included ONLY for completeness of data. They include hit reaction time (HRT), variability (VAR), and perseverations (PRS).~Hit reaction time represents to the average number of milliseconds required for a participant to respond to target stimuli. There are no meaningful absolute minimum or maximum scores, though 101ms is the current fastest verified response time per our review. A higher score is WORSE.~Variability refers to variations in response time across individual blocks of time within the trial. It differs from HRTSD in that HRTSD measures variability across the entire trial. Minimum is 0. There are no absolute maximums. A higher score is WORSE.~Perseverations are errors made either faster than physiologically possible (<100ms). Minimum is 0, there is no maximum. Higher scores are WORSE."|Baseline vs end of open-label (week 8)|Note: One participant's CPT data was invalid|||Units||Standard Deviation|Mean
2598991|NCT02178995|Post-Hoc|QOLIE-89 Additional Subscales (Open-label)|"These are the remaining subscales of the QOLIE-89. These were not pre-specified variables of interest or intentional post-hoc analyses, but are automatically calculated in scoring the QOLIE-89 and are included ONLY for completeness of data submission.~QOLIE aggregate scores and subscale scores are calculated based on individual patient responses throughout the survey, and according to scoring rules as determined by the creator of the questionnaire. Scores are rated 0 (worst) to 100 (best)."|Visit 1 (baseline) vs end of open-label (week 8)||||Points||Standard Deviation|Mean
2598992|NCT02178995|Other Pre-specified|Neuropsychiatric Questionnaires|"Beck Depression Inventory, Beck Anxiety Inventory, Apathy Evaluation Scale. These were not primary or secondary variables of interest given methylphenidate's primary expected action being on cognition. Included given one author's interest, as other studies suggesting psychiatric improvements (particularly apathy and depression) with methylphenidate.~BDI is a common clinical and research measure of depression. It has 21 questions and is scored 0 (no depression) to 63 (most severe depression). A higher score is worse.~BAI is a measure of anxiety, which also has 21 questions and is scored 0 (no anxiety) to 63 (most severe anxiety). A higher score is worse.~AES is a measure of clinical apathy, and is an 18-item scale. It rates symptoms as not at all, slightly, somewhat, or a lot, which are then converted to numerical values 1 (least apathy) to 4 (most apathy). Scores range from 18 (no apathy) to 72 (most apathy)."|Baseline (Visit 1) vs end of Open-label (week 8)||||Points||Standard Deviation|Mean
2598993|NCT02178995|Other Pre-specified|Stimulant Side-effects Checklist|"This is a questionnaire covering common stimulant side-effects, intended to help monitor for any significant or common adverse effects.~The scale lists 16 common stimulant side effects rated 0 (absent) to 9 (serious). Minimum score is 0, maximum is 144. A higher score is WORSE."|Baseline (Visit 1) vs end of Open-label (week 8)||||Points||Standard Deviation|Mean
2598994|NCT02178995|Other Pre-specified|Adverse Events Profile (Open-Label)|"This is a side-effects reporting scale for anti-epileptic medications. Because it encompasses cognitive and non-cognitive side effects, it was not considered one of our main cognitive/quality of life outcomes of interest. It is used in other studies of AED side effects, however, so was included.~The scale consists of 19 symptoms rated 1 (Never a problem) to 4 (Always or often a problem). Minimum score is 19, maximum score is 76. A higher score is WORSE."|Baseline (Visit 1) vs end of Open-label (week 8)||||Points||Standard Deviation|Mean
2598995|NCT02178995|Secondary|CPT Outcomes (Secondary Variables) (Open-label Portion)|"Omissions, commissions, and hits~Hits represents the raw number of accurate responses to target stimuli, out of a maximum of 288. A higher number is better.~Omissions are errors committed when a target stimuli is not appropriately responded to. A higher number is worse. Theoretically, the maximum number of omissions would be 288. A lower number is BETTER.~Commissions are errors committed when a participant responds to a non-target stimuli. Because a participant may make multiple such errors for a given stimuli, there is no raw maximum. A lower number is BETTER."|Baseline (Visit 1) vs end of Open-label (week 8)|Note: one epilepsy participant's CPT data was invalid/unusable due to pressing the wrong button during the trial.|||Points||Standard Deviation|Mean
2598996|NCT02178995|Secondary|QOLIE-89 Selected Cognitive Subscales (Open-label)|"Pre-selected secondary variables were cognitive subscales on the QOLIE-89 felt likely to be affected by MPH: attention/concentration; memory; language; energy/fatigue.~QOLIE aggregate scores and subscale scores are calculated based on individual patient responses throughout the survey, and according to scoring rules as determined by the creator of the questionnaire. Scores are rated 0 (worst) to 100 (best)."|Comparing baseline (visit 1) to end of open-label (end of week 8)||||Points||Standard Deviation|Mean
2598997|NCT02178995|Secondary|Seizure Frequency/Severity (Double-blind Portion)|Seizures per 28 'at-risk' days. This is a comparison of 28 days prior to baseline visit as compared to seizure rate while taking methylphenidate, adjusted to provide a 'number of seizures per 28 days' measurement.|Seizure rate during 28 days prior to study compared to during randomized, single-dose portion, rate adjusted to seizures per 28 patient days.|Only participants who were present in both groups are included here.|||Seizures per 28 at-risk days||Standard Deviation|Mean
2599008|NCT02178800|Secondary|Number of Injectable Hormonal-contraception-using Female Participants Who Discontinue Study Product for Reasons of Toxicity, Tolerability, or Acceptability During Injection Phase||Measured from first injection through 12 weeks after last injection for Cohort 1 and 8 weeks after last injection for Cohort 2|This population includes injectable hormonal-contraception-using female participants who received at least one injection of study drug in the study|||Participants|||Count of Participants
2616782|NCT01987453|Secondary|Percentage of Participants With HCV RNA < LLOQ While on Treatment||Baseline to Week 24|Full Analysis Set|||Percentage of participants|||Number
2598998|NCT02178995|Secondary|CPT Scores (Double-blind Portion) (Secondary Variables)|"Secondary variables in CPT: hits, omissions, commissions~Hits represents the raw number of accurate responses to target stimuli, out of a maximum of 288. A higher number is better.~Omissions are errors committed when a target stimuli is not appropriately responded to. A higher number is worse. Theoretically, the maximum number of omissions would be 288. A lower number is BETTER.~Commissions are errors committed when a participant responds to a non-target stimuli. Because a participant may make multiple such errors for a given stimuli, there is no raw maximum. A lower number is BETTER."|Difference between scores on MPH 20mg, 10mg, or placebo during randomized visits weeks 2, 3, or 4||||Units||Standard Deviation|Mean
2598999|NCT02178995|Primary|QOLIE-89 Aggregate Score|"QOLIE-89 is a questionnaire to assess quality of life and subjective cognitive effects. The aggregate score is the overall calculated score. Note: most of its questions are specific to patients with epilepsy, and therefore the questionnaire cannot be validly completed by healthy controls. Therefore, only participants with epilepsy completed the questionnaire.~QOLIE aggregate scores and subscale scores are calculated based on individual patient responses throughout the survey, and according to scoring rules as determined by the creator of the questionnaire. Scores are rated 0 (worst) to 100 (best)."|Change from baseline to end of methylphenidate open label treatment (end month 2)||||Points||Standard Deviation|Mean
2599000|NCT02178995|Primary|Seizure Frequency (Open-label Portion)|Seizures per 28 'at-risk' days. This is a comparison of 28 days prior to baseline visit as compared to seizure rate while taking methylphenidate, adjusted to provide a 'number of seizures per 28 days' measurement.|Randomized portion is followed by 1-month open-label portion.|This analysis only compares the 28 participants who were present in both groups. Participants who participated only in the double-blind portion are represented in that analysis.|||Seizures per 28 at-risk days||Standard Deviation|Mean
2599001|NCT02178995|Primary|MCG (Open-label Portion)|MCG paragraph memory test is a measure verbal memory. Participants are read aloud a long, detailed story, and are then asked to immediately repeat all information they can remember from the story. Each pertinent story element (as pre-defined on a key) is considered 1 correct response. Minimum score is 0, maximum is 100. A higher score is better.|The single-dose double blind phase was followed by an open-label 4-week treatment phase.||||Points||Standard Deviation|Mean
2599002|NCT02178995|Primary|Symbol-digit Matching Test (Open Label Phase)|Symbol-digit matching test is a measure processing speed and working memory. The task involves matching nonsense symbols with numbers based on a key as quickly as possible within 90s. Score represents the number of correct responses within the time frame. Minimum score is 0. There is not a meaningful 'maximum' score, as there are too many symbols for a participant to successfully complete within the allotted time. A higher score is better.|The single-dose double blind phase was followed by an open-label 4-week treatment phase.||||points||Standard Deviation|Mean
2599003|NCT02178995|Primary|Conners CPT Outcomes (Primary Variables) (Open-Label Portion)|"Within-groups comparison (between visit 1 and visit 5 within patients with epilepsy, comparing scores at baseline to scores on methylphenidate) as well as a comparison against healthy controls who repeated the cognitive measures an equal number of times (to assess and control for test/retest and placebo improvements).~D' represents 'detectability,' and is a derived statistic which measures a participant's ability to distinguish target stimuli from non-target stimuli, and incorporates response time and accuracy factors. The equation for deriving it is proprietary to the test which markets the CPT. A higher, or less negative, score is considered WORSE.~HRTSD represents the standard deviation of participant hit reaction time data, as measured for a variety of different stimuli types across the trial. It is a measure of the participant's ability to maintain attention across the trial. A higher score represents more variability and is considered WORSE."|Difference between scores at baseline (visit 1) and on methylphenidate open-label (visit 5), compared to untreated healthy controls|PLEASE NOTE: One participant with epilepsy did not record any usable data for Conners CPT due to pressing the wrong key throughout large portions of the trial. Therefore, he is not included in CPT variables (but is included in other analyses).|||Units||Standard Deviation|Mean
2599004|NCT02178995|Primary|MCG Paragraph Memory Test (Double-blind Portion)|MCG paragraph memory test is a measure of verbal memory. Participants are read aloud a long, detailed story, and are then asked to immediately repeat all information they can remember from the story. Each pertinent story element (as pre-defined on a key) is considered 1 correct response. Minimum score is 0, maximum is 100. A higher score is better.|Difference in scores between MPH 20mg, 10mg, or placebo, randomized to be given at weeks 2, 3, or 4||||Points||Standard Deviation|Mean
2599005|NCT02178995|Primary|Symbol-digit Matching Test (Double-blind Portion)|Symbol-digit matching test is a measure processing speed and working memory. The task involves matching nonsense symbols with numbers based on a key as quickly as possible within 90s. Score represents the number of correct responses within the time frame. Minimum score is 0. There is not a meaningful 'maximum' score, as there are too many symbols for a participant to successfully complete within the allotted time. A higher score is better.|Difference in scores between MPH 20mg, 10mg, or placebo during double-blind portion during which medication was randomized to weeks 2, 3, or 4.||||points||Standard Deviation|Mean
2599006|NCT02178995|Primary|Conners' Continuous Performance Test (CPT) (Double-blind Portion, Primary Variables)|"Scores on this test measure attentiveness/vigilance and response time. Primary measures are: D', HRTSD D' represents 'detectability,' and is a derived statistic which measures a participant's ability to distinguish target stimuli from non-target stimuli, and incorporates response time and accuracy factors. The equation for deriving it is proprietary to the test which markets the CPT. A higher, or less negative, score is considered WORSE.~HRTSD represents the standard deviation of participant hit reaction time data, as measured for a variety of different stimuli types across the trial. It is a measure of the participant's ability to maintain attention across the trial. A higher score represents more variability and is considered WORSE."|difference in scores on specific variables between MPH 20mg, 10mg, and placebo (randomized to administration at weeks 2, 3, or 4)||||Units||Standard Deviation|Mean
2599007|NCT02178800|Secondary|Number of Participants Who Discontinue Oral Study Product for Reasons of Toxicity, Tolerability, or Acceptability Prior to Completion of the Oral Phase|Stratified by arm|Measured through Week 4||||Participants|||Count of Participants
2599262|NCT02176226|Secondary|Mean Number of Treatment App Use Sessions by Study Week||Weekly for Two Months|Of the 99 participants who initiated the treatment, 96.0% (95/99) continued to use the apps at week 5 and 90.1% (90/99) continued through week 8.|||number of treatment app use sessions||Standard Deviation|Mean
2599010|NCT02178800|Secondary|Number of Injectable Hormonal-contraception-using Female Participants Experiencing Grade 2 or Higher Clinical AE and Laboratory Abnormalities During Injection Phase||Measured from first injection through 12 weeks after last injection for Cohort 1 and 8 weeks after last injection for Cohort 2|This population includes injectable hormonal-contraception-using female participants who received at least one injection of study drug in the study|||Participants|||Count of Participants
2599011|NCT02178800|Secondary|Number of Injectable Hormonal-contraception-using Female Participants Experiencing Grade 2 or Higher Clinical AE and Laboratory Abnormalities During Oral Phase|An adverse events (AE) or laboratory abnormality can be an unfavorable or unintended sign, symptom or disease temporally associated with the use of an investigational product, whether or not considered related to the product. AE severity was graded per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 2.0, November 2014. The outcome in this table is stratified by arm.|Measured through Week 4|This population includes injectable hormonal-contraception-using female participants in the study|||Participants|||Count of Participants
2599012|NCT02178800|Secondary|Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period|Week 29/31 is a combination of week 29, cohort 1 and week 33, cohort 2. The outcome in this table is stratified by arm.|Measured through Week 77|Analysis sample size is different at each visit due to multiple reasons (early termination, missing data, study unblinding, etc.)|||partners||Standard Deviation|Mean
2599013|NCT02178800|Secondary|Number of Participants With HIV Infections Through the Study Period, Stratified by Arm||Measured through Week 105 for Cohort 1 and Week 109 for Cohort 2||||Participants|||Count of Participants
2599014|NCT02178800|Secondary|Number of Participants Willing to Use an Injectable Agent Such as the Study Product for HIV Prevention in the Future|Stratified by Visit and Cohort|Measured from week 6 through Week 30 in cohort 1 and Week 34 in cohort 2|Sample size varies by visit due to reasons such as missing visits and different schedules.|||Participants|||Count of Participants
2599015|NCT02178800|Secondary|Number of Participants Experiencing Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities Prior to Completion of the Oral Phase|An adverse events (AE) or laboratory abnormality can be an unfavorable or unintended sign, symptom or disease temporally associated with the use of an investigational product, whether or not considered related to the product. AE severity was graded per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 2.0, November 2014. The outcome in this table is stratified by arm.|Measured through Week 5||||Participants|||Count of Participants
2599016|NCT02178800|Secondary|Number of Participants Experiencing Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities During Tail Phase|An adverse events (AE) or laboratory abnormality can be an unfavorable or unintended sign, symptom or disease temporally associated with the use of an investigational product, whether or not considered related to the product. AE severity was graded per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 2.0, November 2014. The outcome in this table is stratified by arm.|Measured from 12 weeks after last injection through Week 105 for Cohort 1 and 8 weeks after last injection through Week 109 for Cohort 2|This includes participants who entered tail phase|||Participants|||Count of Participants
2599017|NCT02178800|Primary|Plasma Drug Levels of GSK1265744 at Designated Time Points After Each Injection of 744LA (Injectable Formulation of GSK1265744)|Geometric means and 90% prediction intervals by sex at birth and cohort are reported.|Measured through Week 41|PK sample size varies by visit due to reasons such as missing visits, different schedule and sample contamination.|||ug/ml||90% Confidence Interval|Geometric Mean
2599018|NCT02178800|Primary|Number of Participants Who Discontinue Injectable Study Product for Reasons of Toxicity, Tolerability, or Acceptability That Occur From the Initial Injection to Week 41 Among Participants Who Receive at Least One Injection (Injectable Phase Only)|Stratified by arm|Measured through Week 41|This population includes participants who received at least one injection in the study.|||Participants|||Count of Participants
2599019|NCT02178800|Primary|Number of Participants Experiencing Any Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities That Occur From the Initial Injection to Week 41 Among Participants Who Receive at Least One Injection (Injectable Phase Only)|An adverse events (AE) or laboratory abnormality can be an unfavorable or unintended sign, symptom or disease temporally associated with the use of an investigational product, whether or not considered related to the product. AE severity was graded per the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 2.0, November 2014. The outcome in this table is stratified by arm.|Measured through Week 41|This population includes participants who receive at least one injection in the study.|||Participants|||Count of Participants
2599020|NCT02178787|Secondary|To Compare Profiles of UTlight Blood Flow (UT_BF) and Regional Oximetry (UT_Ox).|CO2 reactivity will be measured as the slope of regression between UT_BF or UT_Ox and CO2 changes during baseline, hyperventilation, and CO2 re-breathing.|one year|The data analysis has determined that UT_BF and UT_OX signals were not reliable and required further algorithm modification and development during post processing (e.g. raw data signal to noise, signal averaging) that are beyond the scope of the study. Therefore, the results were inconsistent and inconclusive. No results to report.||||||
2599021|NCT02178787|Primary|To Compare Profiles of TCD-blood Flow Velocities (TCD_BFV).|CO2 reactivity will be measured as the slope of regression between TCD_BFV and CO2 changes during baseline, hyperventilation, and CO2 re-breathing.|one year||||cm/sec||Standard Error|Mean
2599022|NCT02178722|Secondary|Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events||Adverse events are assessed every 3 weeks for duration of study participation which is estimated to be 27 months|||||||
2599023|NCT02178722|Secondary|Phase 2: Overall Survival (OS)|Overall survival is determined from the date of first dose until death due to any cause.|Patients are checked for survival every 12 weeks for duration of study participation which is estimated to be a minimum of 18 weeks|||||||
2599024|NCT02178722|Secondary|Phase 2: Ordinal Categorical Response Score|"Ordinal categorical response score, determined by radiographic disease assessments per irRECIST v1.1. The 5-category ordinal response endpoint is determined at a given timepoint by classifying response into one of the following groups:~= Complete response per irRECIST v1.1~= Very good response, defined as > 60% tumor reduction~= Minor response, defined as > 30% to ≤ 60% tumor reduction~= Stable disease per irRECIST v1.1~= Progressive disease per irRECIST v1.1"|Assessed every 9 weeks for duration of study participation which is estimated to be a minimum of 18 weeks|||||||
2599026|NCT02178722|Secondary|Phase 2: Progression Free Survival (PFS)|Progression-free survival is defined as number of days from the first day of taking study drug to the earlier of death or disease progression by irRECIST v1.1 for select solid tumors and modified Lugano Classification (Cheson et al 2014) for DLBCL.|Response is measured every 9 weeks for duration of study participation which is estimated to be a minimum of 18 weeks|||||||
2599027|NCT02178722|Secondary|Phase 2: Duration of Response (DOR)|Duration of response is the time from the first overall response contributing to an objective response (complete response or partial response) to the date of death or the date of first overall response of progressive disease (whichever is earliest).|Assessed every 9 weeks for duration of study participation which is estimated to be a minimum of 18 weeks|||||||
2599028|NCT02178722|Primary|Phase 2: Objective Response Rate (ORR)|ORR was proportion of participants with best overall response [complete response (CR) or partial response (PR)], per modified Response Evaluation Criteria In Solid Tumors (irRECIST) v1.1 criteria for select solid tumors or modified Lugano Classification for diffuse large B-cell lymphoma (DLBCL).|Assessed every 9 weeks after the first dose of study treatment for the first 2 assessments (Weeks 9 and 18) then every 12 weeks thereafter until data cut-off date of 26 Nov 2018 (approximately 54 months)|The Efficacy Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug. Number analyzed indicated participants analyzed in the respective tumor type.|||percentage of participants|||Number
2599029|NCT02178722|Primary|Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Treatment-Emergent Adverse Events|An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after a participant provides informed consent. A TEAE is any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug. Serious adverse event (SAE) is defined as an event that meets 1 of the following criteria: is fatal or life threatening, results in persistent or significant disability or incapacity, constitutes a congenital anomaly or birth defect, is clinically meaningful (i.e. defined as an event that jeopardizes the participant or requires potential medical or surgical intervention to prevent 1 of the outcomes listed above) or requires inpatient hospitalization or prolongation of existing hospitalization.|From study start up to clinical data cut-off date of 26 Nov 2018 (approximately 54 months)|Safety Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug.|||percentage of participants|||Number
2599030|NCT02178709|Secondary|Disease Control Rate (Percentage of Patients With Complete Response, Partial Response, or Stable Disease)|"Measured by RECIST v1.1~Complete response: Disappearance of all target lesions Partial response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter Stable disease: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started~The percentage of patients with objective response and its 95% confidence interval will be provided."|Up to 4 months|Patients who received four treatments of FOLFIRINOX and had at least one post-baseline assessment.|||percentage of participants||95% Confidence Interval|Number
2599031|NCT02178709|Secondary|Objective Response Rate (Percentage of Patients With Complete Response or Partial Response)|"Measured by RECIST v1.1 Complete response: Disappearance of all target lesions Partial response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter~The percentage of patients with objective response and its 95% confidence interval will be provided."|Up to 4 months|Patients who received four treatments of FOLFIRINOX and had at least one post-baseline assessment.|||percentage of participants||95% Confidence Interval|Number
2599032|NCT02178709|Secondary|Overall Survival|Overall survival was defined as the time from on study date to death due to any cause. Patients who remained alive were censored at their last known alive date. The Kaplan-Meier method was used to determine the median and 95% confidence interval.|Up to 4 years|All patients who received at least two doses of FOLFIRINOX (unless treatment-related toxicity precluded additional doses) and had at least one post-baseline assessment or died before any evaluation.|||months||95% Confidence Interval|Median
2599033|NCT02178709|Secondary|Disease Free Survival|Disease free survival is defined as the time from on study date to evidence of tumor recurrence or death from any cause. Patients who remained alive and disease free were censored at their date of last disease evaluation.|Up to 3 years|All patients who received at least two doses of FOLFIRINOX (unless treatment-related toxicity precluded additional doses) and had at least one post-baseline assessment or died before any evaluation.|||months||95% Confidence Interval|Median
2599034|NCT02178709|Secondary|Rate of R0 Resection|The percentage of patients with a final margin status of R0 after resection of their primary tumor and its 95% confidence interval will be provided. R0 resection indicates a microscopically margin-negative resection, in which no cancer cells seen microscopically at the primary tumor site.|Up to 4 months|All patients who completed surgery.|||percentage of participants||95% Confidence Interval|Number
2599035|NCT02178709|Secondary|Percentage of Patients Who Successfully Underwent Surgery After Neoadjuvant FOLFIRINOX|The percentage of patients who successfully underwent surgery after neoadjuvant FOLFIRINOX and its 95% confidence interval will be provided.|Up to 4 months|All patients who received at least two doses of FOLFIRINOX (unless treatment-related toxicity precluded additional doses) and had at least one post-baseline assessment or died before any evaluation.|||percentage of participants||95% Confidence Interval|Number
2599036|NCT02178709|Secondary|Number of Patients With Treatment-Related Adverse Events Grade 3 or Above|Number of unique patients who had a treatment-related (possible, probable, or definite) adverse event with grade 3 or greater using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Every 15 days for approximately 6 months|All patients who received at least one dose of FOLFIRINOX.|||Participants|||Count of Participants
2599090|NCT02177942|Secondary|Number of Ill Days at 6 Months|Number of ill days due to cold, cough and/or associated fever were recorded. The mean number of ill days due was analyzed at 6 months using Analysis of Variance (ANOVA).|Baseline upto 6 months|ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population.|||Number of days||Standard Deviation|Mean
2599037|NCT02178709|Primary|Percentage of Patients With Pathologic Complete Response|"Pathologic complete response was evaluated using MRI or CT and Evan's criteria for pathologic response following neoadjuvant therapy:~I: <10% to no tumor cells destroyed IIa: 10-50% of tumor cells destroyed IIb: 50-90% of tumor cells destroyed III: >90% of tumor cells destroyed IIIM: sizable pools of cellular mucin IV: No viable tumor cells (complete pathologic response) IVM: Acellular pools of mucin"|Up to 4 months|All patients who received at least two doses of FOLFIRINOX (unless treatment-related toxicity precluded additional doses) and had at least one post-baseline assessment or died before any evaluation.|||percentage of participants||95% Confidence Interval|Number
2599038|NCT02178696|Secondary|Montgomery-Asberg Depression Rating Scale|"Designed in 1979 by researchers as an adjunct to the Hamilton Rating Scale for Depression (HAMD) which would be more sensitive to the changes brought on by antidepressants and other forms of treatment than the Hamilton Scale. MADRS was used to assess symptoms during the open label antidepressant treatment phase, so results are described as mean scores at each bi-weekly visit.~Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 where 0 is no depression and 60 is most extreme depression.~The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts~Usual cutoff points are:~0 to 6 - normal[5] /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression"|Screening, week 0, week 2, week 4, week 8 and week 10||||Units on a scale||Standard Deviation|Mean
2599039|NCT02178696|Secondary|Hamilton Depression Rating Scale Scores|"The total score is obtained by summing the score of each item, 0-4 (symptom is absent, mild, moderate, or severe) or 0-2 (absent, slight or trivial, clearly present). For the 17-item version, scores can range from 0 to 54, with 0 meaning no depression, and 54, severe depression.~The Hamilton Depression Rating Scale was used to assess symptoms during the open label antidepressant treatment phase, so results are described as mean scores at each bi-weekly visit."|Screening, week 0, week 2, week 4, week 8 and week 10||||Units on a scale||Standard Deviation|Mean
2599040|NCT02178696|Secondary|Changes From Baseline in PHQ-9 Depression Scores.|"The Patient Health Questionnaire-9, is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression, based on participant answers. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression, respectively. The minimum possible score is 0 and the maximum possible score is 27.~The PHQ-9 and QIDS were used to assess changes in mood during the placebo intervention (first 2 weeks), and therefore results are described as changes from the inactive to the active condition."|From Pre to post- active placebo, and from pre to post- inactive placebo (1 week intervention)|"Changes in PHQ-9 score from the beginning of the active/inactive placebo and the end of active/inactive PET scan.~Approximately 1-2 weeks between the two conditions."|||Units on a scale||Standard Deviation|Mean
2599041|NCT02178696|Secondary|Changes From Baseline in Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16) Score|"This scale is a self-report measure of depression with 16 items.~Questions in the QIDS - SR-116 correlate with the nine DSM-IV symptom criterion domains, Including: Sleep disturbance (initial, middle, and late insomnia or hypersomnia) (Q 1 - 4), Sad mood (Q 5), Decrease/increase in appetite/weight (Q 6 - 9), Concentration (Q 10), Self-criticism (Q 11), Suicidal ideation (Q 12), Interest (Q 13), Energy/fatigue (Q 14), Psychomotor agitation/retardation (Q 15 - 16).~Severity of depression can be judged based on the total score: 1-5= No depression; 6-10= Mild depression; 11-15= Moderate depression; 16-20= Severe depression; 21-27= Very severe depression.~The PHQ-9 and QIDS were used to assess changes in mood during the placebo intervention (first 2 weeks), and therefore results are described as changes from the inactive to the active condition."|From Pre to post- active placebo, and from pre to post- inactive placebo (1 week intervention)|"Changes in QIDS-16SR from screening active/inactive placebo condition to the post scan active/inactive placebo condition.~Approximately 1-2 weeks between the two conditions."|||Units on a scale||Standard Error|Mean
2599042|NCT02178696|Secondary|Changes in Dopamine (D 2/3) Binding Potential During PET.|"Binding Potential= Bmax/Kd (receptor concentration/affinity). This is the most common measure of in vivo receptor binding with PET.~Striatal changes in D2/3 receptor binding potential during PET from the Inactive to the Active condition.~Positive numbers presented here represented reductions in binding potential from the inactive to the active condition."|(90 minute PET scan) assessed at Weeks 1 and 2|Data was only collected in 26 subjects as proposed.|||Binding potential ratio||Standard Deviation|Mean
2599043|NCT02178696|Primary|Changes in BOLD Response During Reward fMRI Task (Monetary Incentive Delay, MID)|% BOLD signal changes in the nucleus accumbens from the Inactive to the Active Placebo condition.|(90 minute fMRI scans) assessed at Weeks 1 and 2|Data was missing in 11 subjects due to movement artifacts, or incidental findings that made the data not usable.|||% BOLD changes from Inactive to Active||Standard Deviation|Mean
2599044|NCT02178696|Primary|Changes in Mu-opioid Binding Potential During PET|"Binding Potential = Bmax/Kd (receptor concentration/affinity). This is the most common measure of in vivo receptor binding with positron emission tomography. Whole brain changes in mu-opioid receptors binding potential during PET from the Inactive to the Active placebo condition.~Positive numbers presented here represent reductions in binding potential from the inactive to the active condition."|(90 minute PET scans) assessed at Weeks 1 and 2|Data in four subjects was missing due to failure in the synthesis of the radio tracer for at least one of the two scans.|||Binding potential ratio||Standard Deviation|Mean
2599045|NCT02178592|Secondary|Number of Participants With Treatment-emergent Phenotypic Resistance|Phenotypic susceptibility to all licensed antiretroviral drugs, including DTG and EFV were determined using PhenoSense HIV assays from Monogram Inc. Clinical cutoffs or biological cutoffs by PhenoSense were used to define the phenotypic susceptibility of background treatment and were interpreted as fold change > clinical lower cut-off or biologic cut-off= resistance, fold change >=clinical lower cut-off or biologic cut-off =sensitive (for bilogical cutoff) and fold change > clinical higher cut-off=resistance, fold change <=clinical higher cut-off and > clinical lower cut-off=partially sensitive, fold change <=clinical lower cut-off=sensitive. Viral Phenotypic population will consist of all participants in the ITT-E population with available on-treatment phenotypic resistance data at the time confirmed virologic withdrawal criteria was met. Only participants available at the specified time points were analyzed (represented by n=x in the category titles).|Up to 52 weeks|Viral Phenotypic population|||Participants|||Count of Participants
2599046|NCT02178592|Secondary|Number of Participants With Treatment-emergent Genotypic Resistance|Whole venous blood samples were obtained from each participants at Screening for resistance testing at the central laboratory (or a laboratory contracted by the central laboratory) and on study plasma for storage samples until Week 52 for potential viral genotypic and phenotypic analyses. Genotypic and phenotypic testing was conducted for participants meeting confirmed virologic withdrawal criteria, i.e., confirmed HIV-1 RNA >=400 copies/milliliter from Week 24 onwards. Genotypic and phenotypic analyses was carried out by Monogram Biosciences using, but not limited to, their Standard Phenosense and GenoSure testing methods for protease (PRO), reverse transcriptase (RT), and integrase assays. Genotypic mutations have been presented for the RT region on codons G190G, K101K, K103K, K65K, V106V and Y181Y. Viral Genotypic population comprised of all participants in the ITT-E population with available on-treatment genotypic data at the time confirmed virologic withdrawal was met.|Up to 52 weeks|Viral Genotypic population.|||Participants|||Count of Participants
2599047|NCT02178592|Secondary|Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS)|Participants were monitored for signs and symptoms of TB-assoc. IRIS. Participants with IRIS symptoms in any adverse events (grade [G] 1 to 4) or HIV assoc. conditions were classified by the Endpoint Adjudication Committee in the following categories as met criteria for TB-assoc. IRIS, possibly met criteria for TB-assoc. IRIS and suspected TB-assoc. IRIS but not possible to adjudicate. Number of participants who were sent to the adjudication committee and were analyzed have been presented.|Up to Week 12|Safety Population|||Participants|||Count of Participants
2599048|NCT02178592|Secondary|Change From Baseline in the Fasting Lipid Profile for Total Cholesterol/HDL Ratio at Weeks 24 and 48|Samples for lipid measurements were obtained in a fasted state at Baseline, Week 24 and Week 48. The parameter assessed during the lipid profile was total cholesterol/HDL ratio. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Change from baseline for a parameter was calculated as the observed value minus the Baseline value.|Baseline and Week 24 and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed (represented as n=x in the category titles).|||Ratio of total cholesterol to HDL||Standard Deviation|Mean
2599049|NCT02178592|Secondary|Percent Change From Baseline in the Fasting Lipid Profile at Weeks 24 and 48|Samples for lipid measurements were obtained in a fasted state at Baseline, Week 24 and Week 48. The parameters assessed during the lipid profile were total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, triglycerides. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Change from baseline for a parameter was calculated as the observed value - the Baseline value.|Baseline, Week 24 and Week 48|Safety Population. Only those participants with data available at the specified time points were analyzed (represented as n=x in the category titles).|||Percent change||Standard Deviation|Mean
2599050|NCT02178592|Secondary|Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities|Blood samples for assessment of clinical chemistry parameters were collected from Day 1 up to 52 weeks. Hematology assessments included basophils, eosinophils, mean corpuscle volume (MCV), erythrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Maximum post-Baseline emergent hematology toxicities were graded using DAIDS toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating).|Up to 52 weeks|Safety Population|||Participants|||Count of Participants
2599051|NCT02178592|Secondary|Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities|Blood samples for assessment of clinical chemistry parameters were collected from Day 1 up to 52 weeks. Clinical chemistry assessments included alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), bilirubin, carbon dioxide, chloride, cholesterol, creatine kinase, creatinine, direct bilirubin, glomerular filtration rate (GFR), glucose, high density lipoprotein (HDL) cholesterol direct, low density lipoprotein (LDL) cholesterol calculation and direct, lactate dehydrogenase, lipase, phosphate, potassium, sodium, total cholesterol, triglycerides, and urea. Maximum post-Baseline emergent chemistry toxicities were graded using Division of Acquired Immune Deficiency Syndrome [DAIDS] toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating).|Up to 52 weeks|Safety population was defined as all participants who received at least one dose of study medication.|||Participants|||Count of Participants
2599052|NCT02178592|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4+) Counts at Week 24 and Week 48|Blood samples were collected for assessment of lymphocyte subsets (CD4+ lymphocyte count) by flow cytometry at Baseline and Weeks 24, 48. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Change from Baseline was calculated subtracting the value at the specified time pint from the Baseline value.|Baseline and Weeks 24 and 48|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|||Cells/millimeter cube||Standard Deviation|Mean
2599053|NCT02178592|Secondary|Percentage of Participants Without Confirmed Virologic Withdrawal and Without Discontinuation Due to Treatment-related Reasons at Week 24 and Week 48|Percentage of participants not meeting confirmed virologic withdrawal criteria nor discontinued due to treatment related reasons at the time of analysis at Week 24 (through Day 210) and Week 48 (through Day 350) is presented by treatment group. The time to meeting confirmed virologic withdrawal criteria or discontinuation due to treatment related reasons (i.e., discontinuation due to drug-related adverse event [AE], or due to protocol defined safety stopping criteria, or due to lack of efficacy) were calculated. Participants who met confirmed virologic withdrawal criteria or discontinuation due to treatment related reasons were considered as Failure. Participants who had not met confirmed virologic withdrawal criteria (per protocol) and were ongoing in the study, or who had discontinued for reasons other than those related to treatment, were censored. This would be the Treatment-Related Discontinuation = Failure (TRDF) data.|Week 24 and Week 48|ITT-E Population|||Percentage of participants||95% Confidence Interval|Number
2599091|NCT02177942|Secondary|Change From Baseline in Arm Muscle Area (AMA) and Arm Fat Area (AFA) at 6 Months|Using the MUAC measurement and TSF measurement, the arm muscle AMA and AFA were calculated i.e. AMA (cm2) = (MUAC-(π*TSF))2/4 π and AFA (cm2) = (MUAC2/4π) - AMA|Baseline and 6 months|ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population.|||Centimeter square Cm^2||Standard Deviation|Mean
2599054|NCT02178592|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/Milliliter at Week 24 in Both EFV and DTG Arms Using the Modified Snapshot Algorithm|The percentage of participants who were responders was assessed at study Week 24 for participants randomized to receive DTG who received at least one dose of this study medication. Response was assessed according to the Modified Snapshot algorithm. In this approach participants with HIV-1 RNA >= 50 copies/milliliter were considered non responders. Participants without HIV-1 RNA data at Week 24 [due to missing data or discontinuation of IP prior to visit window] were also considered as non responders, as well as participants with ART substitutions were not permitted. Substitution of a background NRTI agent was permissible one time if it was due to reasons of drug toxicity.|Week 24|ITT-E Population|||Percentage of participants||95% Confidence Interval|Number
2599055|NCT02178592|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/Milliliter at Week 48 Using the Modified Snapshot Algorithm in the EFV Arm|The percentage of responders was assessed at the study Week 48 for participants randomized to receive EFV who received at least one dose of study medication. Response was assessed using Modified Snapshot algorithm. In this approach participants with HIV-1 RNA >= 50 copies/milliliter were considered non responders. Participants without HIV-1 RNA data at Week 48 [due to missing data or discontinuation of IP prior to visit window] were also considered as non responders, as well as participants with ART substitutions were not permitted. Substitution of a background NRTI agent was permissible one time if it was due to reasons of drug toxicity.|Week 48|ITT-E Population|||Percentage of participants||95% Confidence Interval|Number
2599056|NCT02178592|Primary|Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribeonucleic Acid (HIV-1 RNA) < 50 Copies/Milliliter at Week 48 Using the Modified US Food and Drug Administration (FDA) Snapshot Algorithm|The percentage of participants who were responders was assessed at the study Week 48 for participants randomized to receive DTG who received at least one dose of study medication. Response was assessed using a modified FDA Snapshot algorithm in which participants were not penalised for any single protocol allowed background therapy substitution even if occurs after the first trial visit.. In this approach participants with HIV-1 RNA >= 50 copies/milliliter are considered as non responders. Participants without HIV-1 RNA data at Week 48 [due to missing data or discontinuation of investigational product (IP) prior to visit window] are also considered as non responders, as well as participants with anti-retroviral (ART) substitutions were not permitted. Study drug (i.e. DTG or EFV) was not allowed to be substituted.|Week 48|The intent-to-treat exposed (ITT-E) population comprised of all randomly assigned participants who received at least one dose of IP.|||Percentage of participants||95% Confidence Interval|Number
2599057|NCT02178553|Secondary|Pain Scores at Rest on the Second Postoperative Day|NRS pain scores on a 0-10 scale at rest in the morning on the second postoperative day. Zero indicates no pain, and 10 indicates the worst pain one could imagine.|Each morning for two days postoperative||||NRS pain scores on a scale from 0-10||Standard Deviation|Mean
2599058|NCT02178553|Secondary|Pain Scores at Rest in the Morning on the First Postoperative Day|NRS pain scores on a 0-10 scale at rest at 8 am on the first postoperative day. Zero indicates no pain, and 10 indicates the worst pain one could imagine.|Each morning for two days postoperative||||NRS pain score on a scale from 0-10||Standard Deviation|Mean
2599059|NCT02178553|Primary|Pain Scores With Cough on the Second Postoperative Day|Pain with cough documented using the numerical rating scale pain scores (0-10). Zero indicates no pain, and 10 indicates the worst pain one could imagine.|In the morning (8 am) on the second postoperative day||||score on a scale||Standard Deviation|Mean
2599060|NCT02178553|Primary|Pain Scores With Cough on First Postoperative Day|Pain with cough documented using the numerical rating scale pain scores (0-10)|In the morning (8 am) on first postoperative day||||units on a scale||Standard Deviation|Mean
2599061|NCT02178540|Primary|The Use of the Approved US TOBI Podhaler Instructions for Use (IFU) to Communicates the Information Necessary to Achieve Safe and Effective Use of the Podhaler Device|Recording all use errors and close calls associated with inhalation of one dose of TOBI Podhaler (i.e., inhaling the contents of four placebo capsules via the Podhaler device) by subjects (CF patients, and caregivers, if applicable). The study population consisted of CF patients (and caregivers) naïve to the Podhaler device and untrained in the use of the device. Assessing the root cause of use errors and close calls for 6 defined critical errors (agreed with the FDA) and establishing those which can be attributed to a lack of clarity or presence of ambiguities in the IFU content, i.e., errors attributable to a failure to understand the IFU.|1 Day|The Full Analysis Set (FAS) included all enrolled patients who completed an HF assessment as defined by completion of inhalation of the contents of at least one capsule and related HF assessment.|||Patients failing to understand IFU|||Number
2599062|NCT02178475|Secondary|Characteristics of Participants Who Received On-schedule Pegfilgrastim Primary Prophylaxis|On-schedule pegfilgrastim primary prophylaxis was defined as participants who received pegfilgrastim in cycle 1 and continued to receive pegfilgrastim across all cycles, administered 1-3 days after the end of cytotoxic chemotherapy in each cycle.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Participants who received pegfilgrastim across all cycles, administered 1- 3 days after the end of cytotoxic chemotherapy in each cycle.|||participants|||Number
2599063|NCT02178475|Secondary|Number of Participants Who Permanently Switched From Pegfilgrastim Prophylaxis to Other G-CSF Prophylaxis|The number of participants who received pegfilgrastim prophylaxis from cycle 1 until a cycle when other G-CSF prophylaxis was administered, and this G-CSF or a different G-CSF agent (not pegfilgrastim) was received as prophylaxis at each remaining cycle of the chemotherapy course.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Primary analysis set|||participants|||Number
2599064|NCT02178475|Secondary|Number of Cycles With No G-CSF Prophylaxis in Which Complications of Febrile Neutropenia Occurred|The number of chemotherapy cycles during which complications of febrile neutropenia occurred in which no G-CSF prophylaxis was administered. Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Cycles of chemotherapy for participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered, in which no G-CSF prophylaxis was administered.|||cycles|cycles||Number
2600101|NCT02167074|Secondary|Number of Participants in Whom Target Lesion Was Sampled|records if a target lesion was reached during the procedure using the randomised needle or not|1 day||||Participants|||Count of Participants
2599065|NCT02178475|Secondary|Number of Cycles With No G-CSF Prophylaxis in Which Febrile Neutropenia Events Occurred|The number of chemotherapy cycles during which an event of febrile neutropenia occurred in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of < 0.5 x 10^9/L, or < 1.0 x 10^9/L predicted to fall below 0.5 x 10^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Cycles of chemotherapy for participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered.|||cycles|cycles||Number
2599066|NCT02178475|Secondary|Number of Participants Who Experienced Complications of Febrile Neutropenia During Cycles With No G-CSF Prophylaxis|The number of participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered who experienced complications of febrile neutropenia during a cycle of chemotherapy in which no G-CSF prophylaxis was administered. Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Participants who received at least 1 cycle of chemotherapy in which no G-CSF prophylaxis was administered|||participants|||Number
2599067|NCT02178475|Secondary|Number of Participants Who Experienced Febrile Neutropenia During Cycles With No G-CSF Prophylaxis|The number of participants who received at least one cycle of chemotherapy in which no G-CSF prophylaxis was administered who experienced febrile neutropenia during a cycle of chemotherapy in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of < 0.5 x 10^9/L, or < 1.0 x 10^9/L predicted to fall below 0.5 x 10^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Participants who received at least 1 cycle of chemotherapy in which no G-CSF prophylaxis was administered.|||participants|||Number
2599068|NCT02178475|Secondary|Number of Febrile Neutropenia Events That Occurred During Cycles With No G-CSF Prophylaxis|The number of febrile neutropenia events that occurred during a cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered. Febrile neutropenia was defined as an ANC of < 0.5 x 10^9/L, or < 1.0 x 10^9/L predicted to fall below 0.5 x 10^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|All FN events observed for participants in the primary analysis set|||febrile neutropenia events|febrile neutropenia events||Number
2599069|NCT02178475|Secondary|Percentage of Participants Who Experienced Complications of Febrile Neutropenia|Complications of febrile neutropenia were defined as FN-related hospitalizations and death, and neutropenia-related chemotherapy dose delays and dose reductions.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|primary analysis set|||percentage of participants||95% Confidence Interval|Number
2599070|NCT02178475|Secondary|Reasons for Discontinuation of G-CSF Prophylaxis|"Participants who discontinued G-CSF prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.~Data includes both temporary and permanent discontinuation of G-CSF prophylaxis. Participants may have more than 1 discontinuation reason."|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Participants who received at least 1 cycle of chemotherapy in which no G-CSF prophylaxis was administered.|||participants|||Number
2599071|NCT02178475|Secondary|Reasons for Discontinuation of Pegfilgrastim Prophylaxis|"Participants who discontinued pegfilgrastim prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles.~Data includes both temporary and permanent pegfilgrastim discontinuation."|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Participants who received at least 1 cycle of chemotherapy in which no pegfilgrastim prophylaxis was administered, but another G-CSF was administered.|||Participants|||Count of Participants
2599072|NCT02178475|Secondary|Number of Cycles With no G-CSF Prophylaxis|A cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|All cycles of chemotherapy for participants in the primary analysis set|||cycles|cycles||Number
2599073|NCT02178475|Secondary|Number of Cycles With No Pegfilgrastim Prophylaxis|A cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|All cycles of chemotherapy for participants in the primary analysis set|||cycles|cycles||Number
2599074|NCT02178475|Secondary|Characteristics of Participants Who Discontinued G-CSF Prophylaxis|"Participants who discontinued G-CSF prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.~Data includes both temporary and permanent discontinuation of G-CSF prophylaxis."|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Participants who received at least 1 cycle of chemotherapy in which no G-CSF prophylaxis was administered.|||participants|||Number
2599075|NCT02178475|Secondary|Characteristics of Participants Who Discontinued Pegfilgrastim Prophylaxis|"Participants who discontinued pegfilgrastim prophylaxis are participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other G-CSF prophylaxis was administered in this cycle. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles.~Data includes both temporary and permanent pegfilgrastim discontinuation."|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Participants who received at least 1 cycle of chemotherapy in which no pegfilgrastim prophylaxis was administered, but another G-CSF was administered.|||participants|||Number
2599298|NCT02175979|Primary|Number of Patients Developing Postoperative Ileus|number of patients with absence of flatus or stool passage and inability to tolerate a regular oral diet between surgery and postoperative day 4|up to 3 weeks after surgery||||Participants|||Count of Participants
2599076|NCT02178475|Secondary|Number of Participants Who Discontinued G-CSF Prophylaxis|"Participants who discontinued G-CSF prophylaxis was defined as participants who received at least one cycle of chemotherapy (cycle 2 or later) in which no G-CSF prophylaxis was administered.~Discontinuation was categorized as either temporary (participant received G-CSF prophylaxis in at least one subsequent cycle) or permanent (participant had at least one cycle of chemotherapy following the cycle in which no G-CSF prophylaxis was administered, and no G-CSF prophylaxis was administered in any subsequent cycle, OR participant did not receive G-CSF prophylaxis in the last cycle of chemotherapy)."|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Primary analysis set|||participants|||Number
2599077|NCT02178475|Secondary|Number of Participants Who Discontinued Pegfilgrastim Prophylaxis|"Participants who discontinued pegfilgrastim prophylaxis was defined as participants who received at least one cycle of chemotherapy (cycle 2 or later) in which pegfilgrastim prophylaxis was not administered, but other granulocyte colony-stimulating factor (G-CSF) prophylaxis was administered. Participants in this group received either pegfilgrastim or other G-CSF prophylaxis in all chemotherapy cycles.~Discontinuation was categorized as either temporary (participant received pegfilgrastim prophylaxis in at least one subsequent cycle) or permanent (participant had at least one cycle of chemotherapy following the cycle in which no pegfilgrastim prophylaxis was administered, and other G-CSF prophylaxis (i.e. not pegfilgrastim) was administered in all subsequent cycles, OR participant did not receive pegfilgrastim prophylaxis in the last cycle of chemotherapy, and other G-CSF prophylaxis was administered)."|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Primary analysis set|||participants|||Number
2599078|NCT02178475|Primary|Percentage of Participants With Febrile Neutropenia|Febrile neutropenia (FN) was defined as an absolute neutrophil count (ANC) of < 0.5 x 10^9/L, or < 1.0 x 10^9/L predicted to fall below 0.5 x 10^9/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.|Participants were followed for up to 8 cycles of chemotherapy; the average observation time was 4.1 months.|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
2599079|NCT02178241|Secondary|Incidence of Adverse Events.|"Toxicities that Occurred in 10% or More of Patients or At Least Once as a Grade 3+ Adverse Event (excluding those toxicities classified as unrelated or unlikely related to study drugs). Toxicities graded using CTCAEv4 criteria."|Up to 36 months||||participants|||Number
2599080|NCT02178241|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|From start of treatment until death from any cause ,up to 36 months||||months||95% Confidence Interval|Median
2599081|NCT02178241|Secondary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From the start until progression, death, or the start of another treatment, assessed up to 12 months||||months||95% Confidence Interval|Median
2599082|NCT02178241|Primary|Observed Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Observed Overall Response Rate = Number of patients who experienced a confirmed CR or PR divided by the number of eligible patients who began treatment.|Up to 36 months||||percentage of participants||95% Confidence Interval|Number
2599083|NCT02178059|Primary|Maximum Observed Plasma Concentration (Cmax)|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose|The PK analysis set included all healthy subjects who received at least 1 dose of the IMP and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the IMP.|||nmol/L||95% Confidence Interval|Geometric Mean
2599084|NCT02178059|Secondary|Terminal Half-life (t1/2)|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose||||hour||Geometric Coefficient of Variation|Geometric Mean
2599085|NCT02178059|Secondary|Area Under the Plasma Concentration-time Curve From Zero to 36 Hours Postdose [AUC(0-36)]|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose||||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2599086|NCT02178059|Secondary|Area Under the Plasma Concentration-time Curve From Zero Extrapolated to Infinity (AUC)|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose||||nmol*h/L||95% Confidence Interval|Geometric Mean
2599087|NCT02178059|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose||||hour||95% Confidence Interval|Median
2599088|NCT02178059|Primary|Area Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)]|These will be taken at each treatment period|Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose|The PK analysis set included all healthy subjects who received at least 1 dose of the IMP and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the IMP.|||nmol*h/L||95% Confidence Interval|Geometric Mean
2599089|NCT02177942|Secondary|Change From Baseline in Problem Solving at 6 Months|"Test measured visual construction ability, understanding of spatial relationships and problem solving abilities. The child arranged flat shapes of various sizes and colors (items) to match a model or picture as instructed by the qualified staff. For items 1 to 2 (score 2 for success on first trial and 1 on second trial); items 3 to 10 (Score 1 for success and 0 for failure on first trial). The test continued till 3 consecutive scores of 0. The Raw score was the total of item score.~Score range 0-29. Higher scores reflect better short term memory"|Baseline and 6 months|ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
2599092|NCT02177942|Secondary|Change From Baseline in Mid Upper Arm Circumference (MUAC) at 6 Months|The MUAC (single measurement) was measured midway between the acromion and the olecranon process, while the participant stands with the elbow flexed at 90. The circumference was measured with a fiber glass tape to the nearest 0.1 cm on the right hand.|Baseline and 6 months|ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population.|||cm||Standard Deviation|Mean
2599093|NCT02177942|Secondary|Change From Baseline in Triceps Skin Fold (TSF) at 6 Months|The TSF was measured in the midline of the posterior aspect of the arm, over the triceps muscle, at a level midway between the lateral projection of the acromion process of the scapula and the inferior margin of the olecranon process of the ulna. The right elbow is flexed at 90°and the midpoint between the acromion and the olecranon process is located and marked at the lateral side of the arm. The skinfold was then measured with the arm hanging loosely while standing. The triceps skinfold was picked up with the left thumb and index finger approximately 1cm proximal to the marked level and the tips calipers were applied to the skin-fold at the marked level. The triceps measurement was done (three measurements) using Holtain calipers to the nearest 0.2 millimeters (mm) and the average value was recorded.|Baseline and 6 months|ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population.|||mm||Standard Deviation|Mean
2599094|NCT02177942|Secondary|Change From Baseline in Body Mass Index (BMI) at 6 Months|BMI for was obtained using the World Health Organization Anthroplus software version 1.0.2.|Baseline and 6 months|ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population.|||kg/m^2||Standard Deviation|Mean
2599095|NCT02177942|Secondary|Change From Baseline in Height at 6 Months|Height was measured (single measurement) using a portable stadio-meter, with the participant standing bare-foot, to the nearest 0.1centimeters (cm).|Baseline and 6 months|ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population.|||cm||Standard Deviation|Mean
2599096|NCT02177942|Secondary|Change From Baseline in Weight at 6 Months|Weight was measured (single measurement) in standard clothing on weighing scale to the nearest 0.1kilograms(kg).|Baseline and 6 months|ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population.|||kg||Standard Deviation|Mean
2599097|NCT02177942|Primary|Change From Baseline in Short Term Memory at 6 Months|Short term memory was measured using word order and number recall sub tests of Kaufman Assessment Battery for Children (KABC).In Number Recall, child was asked to repeat series of number in same sequence after making sure that child is paying attention.A score of 0 and 1 given for incorrect and correct response respectively. In Word Order,qualified site staff said series of words and child then pointed pictures of those words in same sequence.Later items (object cards with pictures) included an interference task in which child named colors after hearing the word. Each subtest score was the total of item scores, ranging from 0-31 for word order and 0-22 for number recall. The two subtest scores were standardized for each subject and visit (Z score), and short term memory was calculated as the average of the two standardized values where higher scores reflect better short term memory.|Baseline and 6 months|ITT population included all randomized participants who were administered at least one study treatment during the study and provided at least one post-baseline assessment of efficacy which was same as end of study (at 6 months). This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
2599098|NCT02177812|Secondary|Progression-free Survival: Part 2|This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 14 months|All Participants. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.||||||
2599099|NCT02177812|Secondary|Time to Time to Response: Part 2|This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 14 months|All Participants. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.||||||
2599100|NCT02177812|Secondary|Duration of Response: Part 2|This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 14 months|All Participants. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.||||||
2599101|NCT02177812|Secondary|Number of Participants With Abnormal Covariates: Part 2|This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 14 months|All Participants. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.||||||
2599102|NCT02177812|Secondary|Part 2: Volume of Distribution of GSK2879552 for Part 2|This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Day 1 (pre-dose, 0.5 and 3 hours post dose), Days 4, 8 (pre-dose), Day 15 (pre-dose, 0.5, 1, 4, 6 hours), Weeks 4, 5, 6, 7, 8 and every 4 weeks up to Week 48|PK Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.||||||
2599103|NCT02177812|Secondary|Part 2: Clearance (CL) of GSK2879552 for Part 2|This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Day 1 (pre-dose, 0.5 and 3 hours post dose), Days 4, 8 (pre-dose), Day 15 (pre-dose, 0.5, 1, 4, 6 hours), Weeks 4, 5, 6, 7, 8 and every 4 weeks up to Week 48|PK Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.||||||
2599104|NCT02177812|Secondary|Part 2: Number of Participants With Abnormal Physical Examinations|This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 14 months|All Treated Subjects Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.||||||
2599105|NCT02177812|Secondary|Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings|This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 14 months|All Treated Subjects Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.||||||
2599106|NCT02177812|Secondary|Part 2: Number of Participants With Abnormal Vital Signs|Data was not collected for Part 2 as the study was terminated early during Part 1.|Up to 14 months|All Treated Subjects Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.||||||
2599107|NCT02177812|Secondary|Part 2: Number of Participants With Abnormal Hematology Parameters|Data was not collected for Part 2 as the study was terminated early during Part 1.|Up to 14 months|All Treated Subjects Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.||||||
2599108|NCT02177812|Secondary|Part 2: Number of Participants With Abnormal Clinical Chemistry Parameters|Data was not collected for Part 2 as the study was terminated early during Part 1.|Up to 14 months|All Treated Subjects Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.||||||
2599109|NCT02177812|Secondary|Part 2: Number of Participants With Withdrawals Due to Toxicities|Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to toxicities has been presented. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 14 months|All Treated Subjects Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.||||||
2599110|NCT02177812|Secondary|Part 2: Number of Participants With AE Leading to Dose Reductions or Delays|The number of participants who had any dose reduction or delay have been presented. All dose reductions were due to AEs. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 14 months|All Treated Subjects Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.||||||
2599111|NCT02177812|Secondary|Part 2: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 14 months|All Treated Subjects Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.||||||
2599112|NCT02177812|Secondary|Part 1: Time of Occurrence of Cmax (Tmax) of ATRA|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1 and 15|PK Population. Plasma samples were not quantifiable for ATRA at all end points and hence the PK parameters could not be derived.||||||
2599113|NCT02177812|Secondary|Part 1: Apparent Terminal Phase Half-life (t½) of ATRA|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1 and 15|PK Population. Plasma samples were not quantifiable for ATRA at all end points and hence the PK parameters could not be derived.||||||
2599114|NCT02177812|Secondary|Part 1: Cmax of ATRA|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1 and 15|PK Population. Plasma samples were not quantifiable for ATRA at all end points and hence the PK parameters could not be derived.||||||
2599115|NCT02177812|Secondary|Part 1: AUC(0-t), AUC (0-tau) and AUC(0-inf) of ATRA|Blood samples were collected at indicated time points. The Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1and Day 15|PK Population. Plasma samples were not quantifiable for ATRA at all end points and hence the PK parameters could not be derived.||||||
2599116|NCT02177812|Secondary|Part 1:Percentage of Participants With Objective Response|Objective response rate is defined as the percentage of participants who achieved CR, PR, as per CR but platelet count <100 x 10^9/L and morphologic leukemia free state per response criteria.|Median of 4 weeks drug response|All Treated Subjects.|||Percentage of Participants||95% Confidence Interval|Number
2599117|NCT02177812|Secondary|Part 1:Time Invariance|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. The time invariance of GSK2879552 was estimated by calculating the ratio of the GLS means of the AUC (0-tau) between Day 15 and Day 1 for all dose levels and the corresponding 90 percent CI for each ratio.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1 and 15|PK Population.|||Ratio||90% Confidence Interval|Number
2599130|NCT02177812|Primary|Part 1: Number of Participants With Change From Baseline in Heart Rate|Heart rate was measured after restings for 5 minutes in semi-supine position. Data for participants with heart rate decreased to < 60 beats per minute (bpm), normal or no change, increase to > 100 bpm. Data for worst post Baseline were reported.|Median of 4 weeks of drug exposure|All Treated Subjects Population. Only those participants with available data at the specified time points were analyzed.|||Participants|||Count of Participants
2599118|NCT02177812|Secondary|Part 1: Accumulation Ratio for GSK2879552|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. Accumulation ratio was determined dividing AUC (0-tau) on Day 15 by AUC (0-tau) on Day 1. The ratio of accumulation of GSK2879552 was estimated by calculating the ratio of the geometric least squares (GLS) means of the AUC(0-tau) between Day 15 and Day 1 for all dose levels and the corresponding 90 percent confidence interval (CI) for each ratio.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1 and 15|PK Population. Only those participants with data available at the specified time points were analyzed.|||Ratio||90% Confidence Interval|Number
2599119|NCT02177812|Secondary|Part 1: Time of Occurrence of Cmax (Tmax) of GSK2879552|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. NA indicates that data were not available as standard deviation could not be calculated for a single participant.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1 and 15|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Hours||Full Range|Median
2599120|NCT02177812|Secondary|Part 1: Apparent Terminal Phase Half-life (t½)|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. NA indicates that data were not available as geometric coefficient of variation could not be calculated for a single participant.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1 and 15|PK Population. Only those participants with data available at the specified data points were analyzed.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2599121|NCT02177812|Secondary|Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK2879552|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. NA indicates that data were not available as geometric coefficient of variation could not be calculated for a single participant.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1 and 15|PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2599122|NCT02177812|Secondary|Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration [AUC(0-t)] and AUC Over the Dosing Interval (0-tau) After Repeated Administration|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. NA indicates that data were not available as geometric coefficient of variation could not be calculated for a single participant.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 15|PK Population. Only those participants with available data at the specified time points were analyzed.|||Hour*nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2599123|NCT02177812|Secondary|Part 1: AUC Over the Dosing Interval (0-tau) After Single Dose Administration|Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. NA indicates that data were not available as geometric co-efficient could not be calculated for a single participant.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1|PK Population. Only those participants with available data at the specified time points were analyzed.|||Hour*nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2599124|NCT02177812|Secondary|Part 1: Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration [AUC(0-t)] and From Time Zero (Pre-dose) Extrapolated to Infinite Time [(AUC(0-inf)] After Single Dose Administration|Blood samples were collected at indicated time points. The Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis. NA indicates that data were not available as geometric co-efficient of variation could not be calculated for a single participant.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1|PK Population comprised of all treated participants for whom a PK sample was obtained and analyzed. Only those participants with available data at the specified time points were analyzed (represented by n=X in category titles).|||Hour*nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2599125|NCT02177812|Primary|Part 2: Objective Response Rate of Participants|Objective response rate defined as the percentage of participants who achievied complete remission (CR), partial remission (PR), CRp (as per CR but platelet count <100 x 10^9/L) and morphologic leukemia free state per response criteria. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 14 months|All Treated Subjects Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study||||||
2599126|NCT02177812|Primary|Part 1: Number of Participants With Abnormal Physical Examinations|Data for participants with abnormal physical examinations parameters was planned to be recorded.|Median of 4 weeks of drug exposure|All Treated Subjects Population. The data was not collected as it was not captured within the case report form (CRF).||||||
2599127|NCT02177812|Primary|Part 1: Number of Participants With Abnormal Electrocardiograms (ECGs) Findings|A single 12-lead ECG was performed in semi-recumbent or supine position after 5 minutes of rest for the participant. An ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT intervals was used. Number of participants with any visit post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported.|Median of 4 weeks of drug exposure|All Treated Subjects Population. Only those participants with available data at the specified time points were analyzed.|||Participants|||Count of Participants
2599128|NCT02177812|Primary|Part 1: Number of Participants With Change From Baseline in Respiratory Rate|Respiration rate was measured after resting for 5 minutes in semi-supine position. Data for worst case post-Baseline has been reported. Number of participants with respiratory rate decrease to <12 and increase to >25 has been reported.|Median of 4 weeks of drug exposure|All Treated Subjects Population.|||Participants|||Count of Participants
2599129|NCT02177812|Primary|Part 1: Number of Participants With Change From Baseline in Temperature|Temperature was measured after resting for 5 minutes in semi-supine position. Data for participants with temperature decreased to <=35 Celsius, normal or no change, increase to >=38 Celsius at worst-case post Baseline is reported.|Median of 4 weeks of drug exposure|All Treated Subjects Population.|||Participants|||Count of Participants
2599131|NCT02177812|Primary|Part 1: Number of Participants With Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured after resting for 5 minutes in semi-supine position. Vital signs were graded according to Common Toxicity Criteria for Adverse Events (CTCAE) version 4. An increase is defined as an increase in CTCAE grade relative to Baseline grade. For SBP Grade 0 (<120 millimeters of mercury [mmHg]), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (>=160 mmHg). For DBP Grade 0 (<80 mmHg), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (>=100 mmHg). Data for worst-case post Baseline is reported.|Median of 4 weeks of drug exposure|All Treated Subjects Population. Only those participants with available data at the specified time points were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2599132|NCT02177812|Primary|Number of Participants With Hematology Toxicity Grade Changes From Baseline|Blood samples were collected for analysis of hematology parameters based on common terminology criteria for adverse events (CTCAE) version 4.0, where Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe or medically significant; Grade 4 is life threatening consequences. Data for any grade increase worst-case on-therapy has been provided.|Median of 4 weeks of drug exposure|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2599133|NCT02177812|Primary|Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range|Blood samples were collected to assess hematology parameters like mean corpuscle hemoglobin concentration (MCHC), mean corpuscle hemoglobin (MCH), mean corpuscle volume (MCV) mean platelet volume (MPV), basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, monocytes, platelet count, Red blood cell (RBC) count, reticulocytes, White Blood Cell (WBC) count. Laboratory values were as per local labs per site with own normal ranges. Values above range were reported as high and values below range as low. Data for worst post Baseline were reported. NA indicates that data were not available as standard deviation could not be calculated for a single participant.|Median of 4 weeks of drug exposure|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2599134|NCT02177812|Primary|Number of Participants With Clinical Chemistry Toxicity Grade Changes From Baseline|Blood samples were collected for analysis of clinical chemistry parameters based on common terminology criteria for adverse events (CTCAE) version 4.0, where Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe or medically significant; Grade 4 is life threatening consequences. Data for any increase in grade of worst-case on-therapy has been provided.|Median of 4 weeks of drug exposure|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2599135|NCT02177812|Primary|Number of Participants With Clinical Chemistry Parameters Changes From Baseline With Respect to the Normal Range|Blood samples were collected to assess clinical chemistry parameters like urea/blood urea nitrogen (BUN), calcium, potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, glucose, total carbon dioxide (CO2), gamma glutamyl transferase (GGT), albumin, sodium, alkaline phosphatase, total protein, phosphate, lactate dehydrogenase (LDH). Laboratory values were as per local labs per site with own normal ranges. Values above range were reported as high and values below range as low. Data for worst case post Baseline is reported.|Median of 4 weeks of drug exposure|All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Participants|||Count of Participants
2599136|NCT02177812|Primary|Part 1: Number of Participants With Withdrawals Due to Toxicities|Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to toxicities has been presented.|Median of 4 weeks of drug exposure|All Treated Subjects Population|||Participants|||Count of Participants
2599137|NCT02177812|Primary|Part 1: Number of Participants With AE Leading to Dose Reductions or Delays|The number of participants who had any dose reduction or delay have been presented.|Median of 4 weeks of drug exposure|All Treated Subjects Population|||Participants|||Count of Participants
2599138|NCT02177812|Primary|Part 1: Number of Participants With Dose Limiting Toxicities (DLT)|An event was considered a DLT if it occursed within the first 28 days of treatment, and meets one of the following criteria unless it can be clearly established that the event was unrelated to treatment: hematologic DLT included myelosuppression, Grade >=3 non-hematologic toxicity that is considered clinically significant and lasts >72 hours, Grade 2 toxicity that in the judgment of the investigator and GSK Medical Monitor is dose-limiting and treatment delay of >=42 days due to unresolved toxicity.|Median of 4 weeks of drug exposure|All Treated Subjects Population|||Participants|||Count of Participants
2599139|NCT02177812|Primary|Part 1: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function.|Median of 4 weeks of drug exposure|All Treated Subjects Population comprised of all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2599140|NCT02177786|Secondary|Percentage of Participants Achieving at Least a 30% Reduction From Baseline in Albuminuria (As Measured by Urine Albumin to Creatinine Ratio) at Week 48|Baseline was the average of the last 2 values prior to randomization and the last value on or after the randomization date, but prior to or on the first dose date. Urine Albumin to Creatinine Ratio= urine albumin/urine creatinine.|Baseline; Week 48|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2599141|NCT02177786|Primary|Change in eGFR From Baseline at Week 48|The values of eGFR were calculated using the MDRD equation: eGFR = 175 x Serum Creatinine^-1.154 × age^-0.203 × 1.212 (if participant is black) × 0.742 (if female).|Baseline; Week 48|Full Analysis Set included all randomized participants who took at least 1 dose of study drug.|||mL/min/1.73 m^2||Standard Error|Mean
2616784|NCT01987453|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 Weeks|Safety Analysis Set|||Percentage of participants|||Number
2599142|NCT02177773|Primary|Inter-reader Variability|Inter-reader variability for the number of positive regions will be compared using Kappa statistics. In all cases we will provide point estimates and 95% confidence intervals for effects along with p-values.|1 day|Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication.||||||
2599143|NCT02177773|Secondary|Change in Clinical Stage as Determined by Conventional Imaging and Re-determined by Gallium Ga 68-DOTA-TOC PET Imaging|"Impact on care will be accessed for value added by the investigational Ga-68 DOTA-TOC PET/CT scan similar to assessment for impact on care as in the National Oncology PET registry. A percentage will then be calculated for both Change in stage with a 95% confidence interval determined."|Up to 2 weeks|Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication.||||||
2599144|NCT02177773|Primary|Standardized Uptake Value Maximum (SUVmax)|The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded.|1 day|Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication.||||||
2599145|NCT02177773|Primary|Number of Lesions as Determined by Gallium Ga 68-DOTA-TOC Positron Emission Tomography (PET) Imaging|The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded The five largest lesions will be (1 = benign, 2 = likely benign, 3 = indeterminant, 4 = likely malignant, 5 = malignant). The number of positive body regions using conventional imaging and Ga-68 DOTA-TOC PET/CT will be compared using a paired t-test (or Wilcoxon signed-rank test if the data appear to be non-normally distributed). The Wilcoxon signed-rank test will also be used to compare reader confidence of paired lesions between conventional imaging and Ga-68 DOTA-TOC PET/CT|1 day|Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication.||||||
2599146|NCT02177266|Other Pre-specified|Number of Participants With Serious and Non-Serious Adverse Events||Baseline - 3 months|The data were not analyzed because the 2 subjects enrolled withdrew before completing the study; the study was terminated early due to the difficulty in enrolling subjects.||||||
2599147|NCT02177266|Secondary|Trans-thoracic Echocardiography for Constriction||Baseline to 3 months|The data were not analyzed because the 2 subjects enrolled withdrew before completing the study; the study was terminated early due to the difficulty in enrolling subjects.||||||
2599148|NCT02177266|Primary|Number of Patients With Post Cardiac Surgery Atrial Fibrillation or Post-pericardiotomy Syndrome.||Baseline to 3 months|The data were not analyzed because the 2 subjects enrolled withdrew before completing the study; the study was terminated early due to the difficulty in enrolling subjects.||||||
2599149|NCT02177201|Primary|Postoperative Vomiting|Presence of at least one episode of vomiting within the first 24 hours of postoperative is positive for definition|First 24 hours postoperative||||participants|||Number
2599150|NCT02177136|Secondary|Change From Baseline in Plasma C4||Baseline and 24 weeks|Intent-To-Treat Population|||ng/mL||Inter-Quartile Range|Median
2599151|NCT02177136|Secondary|Change From Baseline in Plasma Fibroblast Growth Factor-19 (FGF-19)||Baseline and 24 weeks|Intent-to-Treat Population|||pg/mL||Inter-Quartile Range|Median
2599152|NCT02177136|Secondary|Change From Baseline in Serum Gamma-Glutamyl Transferase (GGT)||Baseline and 24 weeks|Intent-To-Treat Population|||U/L||Inter-Quartile Range|Median
2599153|NCT02177136|Secondary|Change From Baseline in Serum Direct Bilirubin||Baseline and 24 weeks|Intent-To-Treat Population|||umol/L||Inter-Quartile Range|Median
2599154|NCT02177136|Secondary|Change From Baseline in Serum Total Bilirubin||Baseline and 24 weeks|Intent-To-Treat Population|||umol/L||Inter-Quartile Range|Median
2599155|NCT02177136|Secondary|Change From Baseline in Serum Aspartate Aminotransferase (AST)||Baseline and 24 weeks|Intent-to-Treat Population|||U/L||Inter-Quartile Range|Median
2599156|NCT02177136|Secondary|Change From Baseline in Serum Alanine Transaminase (ALT)||Baseline and 24 weeks|Intent-To-Treat Population|||U/L||Inter-Quartile Range|Median
2599157|NCT02177136|Primary|Change From Baseline in Serum Alkaline Phosphatase (ALP)|The primary efficacy analysis will compare the Week 24 change from Baseline in ALP between OCA treatment group and placebo using an analysis of covariance (ANCOVA) model with fixed effects for treatment group and randomization strata, and Baseline as a covariate.|Baseline and 24 weeks|Intent-to-Treat Population|||U/L||Standard Error|Least Squares Mean
2599158|NCT02177032|Secondary|Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age|Immunogenicity was assessed in terms of the number of subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age|At Days 8, 15,50, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for 4-sites, 1-week with HRIG and 2-sites, TRC with HRIG Groups|||Percentages of Subjects||95% Confidence Interval|Number
2599159|NCT02177032|Secondary|Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age|Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age|At Days 8, 15, 50, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for 4-sites, 1-week with HRIG and 2-sites TRC with HRIG Groups.|||IU/mL||95% Confidence Interval|Geometric Mean
2599160|NCT02177032|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Safety was assessed in terms of the Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Day 1 to Day 366|Unsolicited Safety Set- All subjects in the Exposed Population who have post vaccination unsolicited adverse event records. The number of exposed set participants analyzed for safety is different from the Per Protocol Set (PPS) for immunogenicity.|||Subjects|||Number
2599161|NCT02177032|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination|Number of subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination|From day 1 to day 3; from day 4 to day 7; from day 8 to day 14; from day 29 to day 35(2-sites, TRC PEP, ID regimen)|Solicited Safety Set- All subjects in the Exposed Population who provide post vaccination solicited adverse event data. The number of exposed set participants analyzed for safety is different from the Per Protocol Set (PPS) for immunogenicity.|||Subjects|||Number
2599162|NCT02177032|Secondary|Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age|Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age|At Days 8, 15, 50, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is only applicable for the 4-sites, 1-week without HRIG and 2-sites, TRC without HRIG Groups.|||Percentages of Subjects||95% Confidence Interval|Number
2599163|NCT02177032|Secondary|Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age|Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age|At Days 8, 15, 50, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for the 4-sites, 1-week without HRIG and 2-sites, TRC without HRIG Groups.|||IU/mL||95% Confidence Interval|Geometric Mean
2599164|NCT02177032|Secondary|Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age|"Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age.~Percentage of subjects with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)"|At Days 8, 15,50, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for the 4-sites, 1-week with HRIG and 4-sites, 1-week without HRIG Groups.|||Percentages of Subjects||95% Confidence Interval|Number
2599165|NCT02177032|Secondary|Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age|"Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age.~RVNA GMCs with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)"|At Days 8, 15, 50, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis. This outcome measure is applicable only for the 4-sites, 1-week with HRIG and 4-sites, 1-week without HRIG Groups.|||IU/mL||95% Confidence Interval|Geometric Mean
2599166|NCT02177032|Secondary|Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age|"Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method.~RVNA percentage of subjects with RVNA titer ≥ 0.5 IU/mL at study days 8, 15, 91, 181, and 366 following administration of the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC), with or without HRIG, in the whole study population."|At Days 8, 15, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis.|||Percentages of Subjects||95% Confidence Interval|Number
2599167|NCT02177032|Secondary|Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age|"Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors.~Non-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population."|At Days 8, 15, 91, 181 and 366|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis.|||IU/mL||95% Confidence Interval|Geometric Mean
2599220|NCT02176486|Primary|Percentage of Participants With at Least One Markedly Abnormal Value (MAV) for Hematologic Parameters||Baseline up to Day 168|The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2599221|NCT02176486|Primary|Percentage of Participants Who Experienced at Least One AE Leading to Study Drug Discontinuation||Baseline up to Day 168|The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2599168|NCT02177032|Secondary|Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Between-group (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC) With or Without HRIG) Ratio of GMCs|"Immunogenicity was assessed in terms of Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age at day 50 The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors.~Non-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population."|Study Day 50|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis|||IU/mL||95% Confidence Interval|Geometric Mean
2599169|NCT02177032|Primary|"Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences (4-sites, 1-week to That of 2-sites, TRC ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration)"|"Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method.~Non-inferiority of the immune response of the new 4-sites, 1-week ID PEP regimen of the PCEC vaccine, with or without HRIG administration, to that of the currently recommended 2-sites, TRC ID PEP regimen of the PCEC rabies vaccine with or without HRIG administration, as measured by the percentage of subjects with RVNA titer ≥ 0.5 IU/ml at day 50 in the whole study population."|Study day 50 (D50)|Per Protocol Set (PPS): all subjects who correctly receive the vaccine doses, provided immunogenicity data at the relevant time points and were not excluded due to reasons defined prior to the analysis.|||Percentages of Subjects||95% Confidence Interval|Number
2599170|NCT02176837|Primary|Cerebral Vasospasm|Cerebral digital subtraction angiographies will be reviewed at at least 2 time points, including at the time of diagnosis of angiographic vasospasm immediately before treatment with nitrite and after up to 180 minutes of nitrite infusion. Radiographs will be compared to determine whether increased flow of radiographic dye is visualized following initiation of nitrite infusion.|180 minutes|Patients who received sodium nitrite|||Participants|||Count of Participants
2599171|NCT02176655|Other Pre-specified|Meaningful Headache Relief|Time to meaningful headache relief for VVD-101 vs. placebo. Meaningful headache relief is defined as experiencing substantial relief as reported by the subject.|Time of Onset to Meaningful Headache Relief (up to 24 hours)|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.|||minutes||Standard Deviation|Mean
2599172|NCT02176655|Other Pre-specified|Comparing Acute Hangover Scale Individual Symptoms With Headache Severity 2 Hours Post Treatment|Comparison of headache severity 2 hours post treatment of headache treated with VVD-101 with each associated hangover symptom items on the AHS taken before treatment. Individual Hangover Symptoms Scores range from 0 [None] to 7 [Incapacitating]. The AHS scale is rated on a score of 0-63. A score of 0 indicates no symptoms and a total score of 63 indicates the maximum number of reported symptoms.Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Immediately Before Treatment to 2 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.|||units on a scale||Standard Deviation|Mean
2599173|NCT02176655|Other Pre-specified|Number of Drinks Consumed Compared to Pain Severity 2 Hours Post Treatment|Comparison of the number of drinks consumed at one sitting with pain severity 2 hours post treatment for headaches treated with VVD-101. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Time of Last Sitting to 2 Hours Post Treatment (estimated 14 hours)|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.|||Number of Drinks Consumed||Standard Deviation|Mean
2599174|NCT02176655|Secondary|Acute Hangover Scale Compared to Pain Severity 2 Hours Post Treatment|Comparison of Acute Hangover Scale (AHS) score before treatment with headache pain severity 2 hours post treatment for headaches treated with VVD-101. The AHS scale is rated on a score of 0-63. A score of 0 indicates no symptoms and a total score of 63 indicates the maximum number of reported symptoms. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Immediately Before Treatment of 3 Headaches to 2 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.|||units on a scale||Standard Deviation|Mean
2599175|NCT02176655|Secondary|Satisfaction|To assess subject satisfaction with treatment results comparing VVD-101 vs. placebo. Satisfaction was measured on a 7 point Likert scale whereas 0 = extremely dissatisfied and 6 = extremely satisfied.|24 Hours Post Treatment for 3 Headaches (estimated 6 months)|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.|||units on a scale||Standard Deviation|Mean
2599176|NCT02176655|Secondary|Number of Participants With Consistent Response to VVD-101|To assess the consistency of response to VVD-101 over the three active treatments of VVD-101. Consistency is defined as meeting the requirements of headache relief 2 hours post treatment for 2 out of 3 active treated headaches. Headache relief is defined as a headache going from moderate or severe to mild or no headache or mild headache going to no headache. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Response to Treatment of Three Headaches (estimated 6 months)|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.|||participants|||Number
2599177|NCT02176655|Secondary|Number of Headaches With Sustained Pain Freedom at Twenty Four Hours Post Treatment|Number of headaches with sustained headache pain freedom at 24 hours post treatment for VVD-101 vs. placebo. Sustained headache pain freedom is defined as no pain 2 hours post treatment and headache freedom continuing for 24 hours post treatment without rescue. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Time of Treatment to 24 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects, with 28 headaches were analyzed for this endpoint.|||Headaches|Headaches||Number
2599178|NCT02176655|Secondary|Number of Headaches Relieved to Complete Pain Freedom at Two Hours Post Treatment|Number of headaches relieved (no head pain) at 2 hours post treatment for VVD-101 vs. placebo. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Immediately Prior to Treatment to 2 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects, with 87 headaches were analyzed for this endpoint.|||Headaches|Headaches||Number
2599179|NCT02176655|Secondary|Number of Headaches Relieved|Headache relief from before treatment, at 30 minutes, 1 hour, and 2 hours post treatment in attacks treated with VVD-101 vs. placebo. Headache relief is defined as a headache going from moderate or severe to mild or no headache or mild headache going to no headache. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Immediately Prior to Treatment to 2 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects, with 87 headaches were analyzed for this endpoint.|||Headaches|Headaches||Number
2599180|NCT02176655|Secondary|Headache Severity at Treatment, 30 Minutes and 1 Hour Post Treatment|Change in headache severity from before treatment, at 30 minutes, and 1 hour post treatment in attacks treated with VVD-101 vs. placebo. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Immediately Prior to Treatment through 1 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.|||units on a scale||Standard Deviation|Mean
2599181|NCT02176655|Primary|Headache Severity 2 Hours Post Treatment|Headache severity 2 hours post treatment in sumatriptan succinate 12.5 mg and acetylsalicylic acid 325 mg (VVD-101) vs. placebo. Headache severity was measured on a 4 point Likert scale with 0 = no pain, 1 = mild pain, 2 = moderate, 3 = severe pain.|Immediately Prior to Treatment through 2 Hours Post Treatment|Given the design of the study, all subjects treated headaches 1-6 in a randomized fashion with either VVD-101 or placebo, therefore the same 25 subjects are in the VVD-101 and Placebo analysis population. A total of 25 subjects were analyzed for this endpoint.|||units on a scale||Standard Deviation|Mean
2599182|NCT02176642|Other Pre-specified|Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Side Effects Domain|To compare bother from medication side effects between PTNS plus anticholinergic medication versus PTNS plus placebo using the Treatment Satisfaction Questionnaire for Medication, version two (TSQMvII). The questionnaire was completed at baseline and at 6 weeks. The TSQMvII side effects domain at each time point was transformed into a score from 0 (extremely dissatisfied) to 150 (extremely satisfied). Median change in scores from baseline to 6 weeks were compared between the 2 groups using Wilcoxon Rank Sum Test.|Baseline, 6 weeks|Two patients in the placebo+PTN group did not complete the 6 week TSQMvII questionnaire so was not included in the analysis.|||units on a scale||Inter-Quartile Range|Median
2599183|NCT02176642|Other Pre-specified|Change in Treatment Satisfaction Questionnaire for Medication, Version Two (TSQMvII) - Global Satisfaction Domain|To compare treatment satisfaction between PTNS plus anticholinergic medication versus PTNS plus placebo using the Treatment Satisfaction Questionnaire for Medication, version two (TSQMvII). Patients completed the questionnaire at baseline and again at 6 weeks. The TSQMvII satisfaction domains at each timepjoint were transformed into a score from 0 (extremely dissatisfied) to 100 (extremely satisfied). Median change in scores from baseline to 6 weeks were compared between the 2 groups using Wilcoxon Rank Sum Test.|Baseline, 6 weeks|Two patients in the placebo+PTN group and 1 patient in the oxybutynin+PTNS group did not complete the 6 week TSQMvII questionnaire so was not included in the analysis.|||units on a scale||Inter-Quartile Range|Median
2599184|NCT02176642|Other Pre-specified|Change in the Incontinence Impact Questionnaire (IIQ-7)|The IIQ-7 is a 7-question score assessing how urinary incontinence affects a patient's various activities and feelings. The range of possible scores is from 0 (not at all) to 28 (a great deal). Median change in scores from baseline to 6 weeks were compared between the 2 groups using Wilcoxon Rank Sum test.|Baseline, 6 weeks|1 patient in the oxybutynin+PTNS group did not complete the 6 week IIQ-7 questionnaire so was not included in the analysis.|||units on a scale||Inter-Quartile Range|Median
2599185|NCT02176642|Other Pre-specified|Change in the Urinary Distress Inventory (UDI-6)|The UDI-6 is a 6-question inventory of how frequently and how much bother patients have from overactive bladder symptoms. The scores range from 0 (not at all) to 24 (a great deal of bother). We compared the change in scores from baseline to 6 weeks between the 2 groups using Wilcoxon Rank Sum test.|Baseline, 6 weeks|1 patient in the oxybutynin+PTNS group did not complete the 6 week UDI-6 questionnaire so was not included in the analysis.|||units on a scale||Inter-Quartile Range|Median
2599186|NCT02176642|Other Pre-specified|Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 2|Part 2 of the OABq-SF questionnaire asks about the relative bother a patient experiences with regard to overactive bladder symptoms over the previous 4 weeks. This part of the questionnaire has 13 questions, with scores ranging from 13 (least amount of bother) to 78 (most amount of bother). For this secondary outcome, we are measuring the change in score on the OABq-SF Part 2 from baseline to 6 weeks. Median change in scores were compared between the 2 groups using Wilcoxon Rank Sum test.|Baseline, 6 weeks|Four patients in the oxybutynin+PTNS group and 1 patient in the placebo+PTNS did not submit their OABq-SF part 2 at the end of the study, so they were unable to be included in the analysis.|||units on a scale||Inter-Quartile Range|Median
2616817|NCT01987349|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization||||Participants|||Count of Participants
2599187|NCT02176642|Other Pre-specified|Change in the Overactive Bladder Questionnaire Short Form (OABq-SF) Part 1|Part 1 of the OABq-SF questionnaire asks about the relative bother a patient experiences with regard to overactive bladder symptoms over the previous 4 weeks. This part of the questionnaire has 6 questions, with scores ranging from 6 (least amount of bother) to 36 (most amount of bother). For this secondary outcome, we are measuring the change in score on the OABq-SF Part 1 from baseline to 6 weeks. Median change in scores were compared between the 2 groups using Wilcoxon Rank Sum test.|Baseline, 6 weeks|3 patients in the oxybutynin+PTNS group did not submit their OABq-SF at the end of the study, so they were unable to be included in the analysis.|||units on a scale||Inter-Quartile Range|Median
2599188|NCT02176642|Other Pre-specified|Change in the Patient Global Impression of Improvement (PGI-I)|The Patient Global Impression of Improvement (PGI-I) is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 (Very much better to) 7 (Very much worse).|Baseline, 6 weeks|2 patients in the oxybutynin+PTNS group and one patient in the placebo+PTNS group did not complete the 6 week PGI-I questionnaire so they were not included in the analysis.|||units on a scale||Inter-Quartile Range|Median
2599189|NCT02176642|Secondary|Change in 24hr Pad Weight|To compare the change, from baseline, in 24h pad weight between PTNS plus anticholinergic medication versus PTNS plus placebo. Change in median 24h pad weight from baseline to 6 weeks was compared between the 2 groups using Wilcoxon Rank Sum test.|Baseline, 6 weeks|Six participants in the placebo+PNTS group and 3 patients in the oxybutynin+PTNS group did not provide a pad weight at the end of the study, and thus were unable to have the pad weight change score calculated.|||grams||Inter-Quartile Range|Median
2599190|NCT02176642|Primary|Change in Median Number of UUI Episodes Per Day|To compare the change, from baseline, in median number of UUI episodes per day using a 3-day bladder diary between PTNS plus anticholinergic medication versus PTNS plus placebo in women undergoing treatment for UUI. UUI change score will be calculated [post-treatment UUI/day minus pre-treatment UUI/day].|Baseline, 6 weeks|3 patients in each group did not provide bladder diaries at their 6 week visit, so did not have information available to calculate the primary outcome measure. Median change in UUI episodes/day from baseline to 6 weeks was compared between 2 groups using Wilcoxon Rank Sum test.|||Urge urinary incontinence episodes/day||Inter-Quartile Range|Median
2599191|NCT02176525|Secondary|Body Temperature|The body temperature will be presented as the mean values in visit 1 and visit 7. The number of participants analysed displays the number of participants included in the analysis set whereas the numbers for each timepoint display the number of participants with available data at that timepoint.|Visit 1, Visit 7|Treated set.|||degree (°C)||Standard Deviation|Mean
2599192|NCT02176525|Secondary|Assessment of Global Tolerability on a 4-point Scale|The global tolerability was presented on a four item scale: good, satisfactory, not satisfactory and bad. Rating was done by the investigator.|day 6|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.|||participants|||Number
2599193|NCT02176525|Secondary|Number of Patients With Abnormal Findings in Physical Examination|The number of patients with abnormal findings in physical examination presents the number of patients with any treatment-emergent adverse events in this study.|up to day 14|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.|||participants|||Number
2599194|NCT02176525|Secondary|Number of Patients With Adverse Events|Number of patients with any adverse event (AE)|up to 14 days|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.|||participants|||Number
2599195|NCT02176525|Secondary|Number of Patients With Abnormal Changes in Laboratory Tests|Number of patients with abnormal changes in safety laboratory tests including urine protein diagnostics, and adrenocorticotropic hormone (ACTH) and cortisol measurements resulted in adverse events.|Baseline, up to day 14|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.|||participants|||Number
2599196|NCT02176525|Secondary|Number of Patients With Abnormal Findings in 12-lead ECG (Electrocardiogram)|Number of patients with a new onset of an abnormal finding by central assessment are presented.|up to 14 days|Treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation. Only patients included having no missing ECG measurements .|||participants|||Number
2599197|NCT02176525|Secondary|Number of Patients With Clinically Significant Changes in Vital Signs (Pulse Rate, Systolic and Diastolic Blood Pressure).|Number of patients with clinically significant changes in vital signs (pulse rate, systolic and diastolic blood pressure) presents the number of patients with an reported adverse event which has a symptom in changes in vital signs. Vascular disorders was identified as changes in vital signs. The number of participant with vascular disorders is presented in this outcome measure|Baseline, up to day 14|The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomisation.|||participants|||Number
2599198|NCT02176525|Secondary|Plasma Concentration Time Profiles|Individual drug plasma concentrations of Deleobuvir after multiple oral administration. Within the categories PTM means planned time. The number of participants analysed displays the number of participants included in the analysis data set whereas the number of participants for each timepoint displays the number of participants with available data at that timepoint. Below the limit of quantification (BLQ) is abbreviated.|up to day 7|The full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2599222|NCT02176486|Primary|Percentage of Participants Who Experienced at Least One Treatment Emergent Serious Adverse Event (SAE)||Baseline up to Day 101 (30 days after last dose of study drug)|The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2599450|NCT02174523|Primary|Lurasidone Cmax|Maximum (peak) observed drug serum concentration.|pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose|All subjects with evaluable PK data were included in PK data analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2599199|NCT02176525|Secondary|Vz/F,ss|"Apparent volume of Deleobuvir distribution during the terminal phase λz following an oral dose at steady state (Vz/F,ss) after the last dose of study drug.~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS|||Litre (L)||Geometric Coefficient of Variation|Geometric Mean
2599200|NCT02176525|Secondary|CL/F,ss|"Apparent clearance of Deleobuvir in plasma after oral administration at steady state (CL/F,ss) measured after the last dose of study drug.~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS|||Millilitre per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
2599201|NCT02176525|Secondary|t1/2,ss|"Terminal half-life of Deleobuvir in plasma at steady state (t1/2,ss) measured after the last dose of study drug.~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS|||h||Full Range|Median
2599202|NCT02176525|Secondary|λz,ss|"Terminal rate of Deleobuvir constant in plasma at steady state (λz,ss) measured after last dose of study drug.~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS|||1/h||Full Range|Median
2599203|NCT02176525|Secondary|AUC0-∞,ss|"Area under the concentration-time curve of Deleobuvir in plasma over the interval 0 hour (h) extrapolated to infinity at steady state (AUC0-∞,ss) measured after last administration of trial drug.~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2599204|NCT02176525|Secondary|AUCτ,ss|"Area under the concentration-time curve of Deleobuvir in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) measured after last dose of trial drug.~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2599205|NCT02176525|Secondary|Tmax,ss|Time from dosing to the maximum measured concentration of Deleobuvir at steady state after the last dose of study drug (tmax,ss) more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only)|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS|||h||Full Range|Median
2599223|NCT02176486|Primary|Percentage of Participants Who Experienced at Least One Grade Greater Than or Equal to (>=) 2 Treatment Emergent Adverse Event (TEAE)||Baseline up to Day 101 (30 days after last dose of study drug)|The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2599295|NCT02175979|Secondary|Gastric Motility|Percent change in Gastric Antral Area, assessed by Ultrasound of the Gastric Antrum Following a Standardized Meal|3 days after surgery|not every patients was fit to have the standard meal or ultrasound, therefore less antral measurements were executed.|||percentage of decrease in antral area||Inter-Quartile Range|Median
2599206|NCT02176525|Secondary|Cmin,ss|"The minimum measured concentration of Deleobuvir in plasma at steady state (Cmin,ss).~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only). The number of participants analysed displays the number of participants with available data at the timepoints of interest."|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2599207|NCT02176525|Secondary|Cmax,ss|"The maximum measured concentration of Deleobuvir in plasma at steady state after the last dose of study drug (Cmax,ss).~more detailed time frame information: 5 minutes (min) prior to the first dose of study medication of Day 5 (-0:05) and 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00 h thereafter; Assigned to the planned time points 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h (*At these time points, in patients with cirrhosis only)"|5 min prior to the first dose of study medication of Day 5; 0:30, 1:00, 2:00, 3:00*, 4:00, 6:00, 8:00*, 10:00, 12:00, 16:00, 24:00, 48:00, 95:55, 96:30, 97:00, 98:00 99:00*, 100:00, 102:00, 104:00*, 106:00, 108:00, 112:00, 120:00, 144:00 h thereafter|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2599208|NCT02176525|Secondary|AUC0-τ|Area under the concentration-time curve of Deleobuvir in plasma over the interval 0 hour (h) to the next dose of trial medication (AUC0-τ) measured after first administration of trial drug.|5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1|PKS|||Nanogram*hours/millilitre (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2599209|NCT02176525|Secondary|Tmax|Time from dosing to maximum measured concentration (tmax) of Deleobuvir determined after the first dose.|5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1|PKS|||hours (h)||Full Range|Median
2599210|NCT02176525|Secondary|Cmin|Measured concentration of Deleobuvir in plasma determined immediately before the second dose (Cmin). The number of participants analysed displays the number of participants with available data at the timepoints of interest.|5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2599211|NCT02176525|Secondary|Cmax|Maximum measured concentration of Deleobuvir in plasma (Cmax) determined after the first dose.|5 minutes (min) prior to the first dose of study medication and 30 minutes and 1:00, 2:00, 3:00, 4:00, 6:00, 7:55, 10:00, 12:00, 15:55, 18:00 hours (h) thereafter on day 1|The PK set (PKS) included all patients in the full analysis set (FAS) with evaluable PK data. FAS included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||nanogram/millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2599212|NCT02176525|Secondary|Time Dependent Change From Baseline in Viral Load (VL)|Change of VL from baseline to day 7 is presented (VL at timepoint minus VL at baseline). Acronym used within the categories: planned time (PTM). The number of participants analysed displays the number of participants included in the analysis set whereas the number of participants for each timepoint display the number of participants with available data at that timepoint.|Baseline, up to day 7|The full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||log10 (U/L)||Standard Deviation|Mean
2599213|NCT02176525|Primary|Virologic Response (VR)|Virologic response was defined as a ≥ 1 log10 reduction in serum Hepatitis C virus (HCV) Ribonucleic acid (RNA) level from baseline at any time from the start of administration of treatment up to day 5. In this Outcome Measure the percentage of participants with virologic response is presented.|Baseline (Visit 2_2 at planned time 5 minutes prior to first administration of trial drug), up to day 5|The full analysis set (FAS) included all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2599214|NCT02176486|Secondary|Plasma Concentrations of Ixazomib at Each Scheduled Collection Time||Cycle 1 Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose (Cycle length is equal to [=] 28 days)|The pharmacokinetic (PK) set consisted of all participants who received one dose of ixazomib and had at least 1 measurable plasma concentration.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2599215|NCT02176486|Secondary|Change From Baseline in Complement Protein C3 and C4 at Day 84||Baseline and Day 84|The PD set consisted of all participants who received study drug and had at least 1 post dose PD measurement. Participants who were evaluable for this measure at given time period for the arm were included in the category.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2599216|NCT02176486|Secondary|Change From Baseline in Levels of Autoantibodies (Anti-double-stranded Deoxyribonucleic Acid [dsDNA]) at Day 84||Baseline and Day 84|The pharmacodynamics (PD) set consisted of all participants who received study drug and had at least 1 post dose PD measurement. Participants who were evaluable for this measure at given time period for the arm were included in the category.|||international units/milliliter (IU/mL)||Standard Deviation|Mean
2599217|NCT02176486|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Day 84||Baseline and Day 84|The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.|||milliliter/minute/1.73 square meter||Standard Deviation|Mean
2599218|NCT02176486|Secondary|Change From Baseline in Serum Creatinine (sCR) Level at Day 84||Baseline and Day 84|The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.|||micromoles per liter (mcmol/L)||Standard Deviation|Mean
2599219|NCT02176486|Secondary|Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Day 84||Baseline and Day 84|The safety analysis set consisted of all participants who were enrolled and received at least 1 dose of study drug.|||milligram per milligram creatinine||Standard Deviation|Mean
2599296|NCT02175979|Secondary|Aspiration Pneumonia|number of patients developing aspiration pneumonia|up to 3 week after surgery||||Participants|||Count of Participants
2599224|NCT02176421|Secondary|Subject Overall Eye Appearance Total Score on the 5-Point Periorbital Aesthetic Appearance Questionnaire (PAAQ)|Subjects assessed their overall eye appearance on the PAAQ. The PAAQ includes 9 questions about how the subject's overall eye appearance affected them over the past 7 days. Each question is assessed on a 5-point scale from 0 (never/best) to 4 (all of the time/worse), with the total score ranging from 0 (best) to 36 (worse).|Day 0, Day 14, Month 1, Month 6, Month 9, Month 12|All subjects with data for this outcome measure|||Scores on a Scale||Standard Deviation|Mean
2599225|NCT02176421|Secondary|Percentage of Subjects Assessed by the Subjects as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)|The subjects evaluated their global aesthetic improvement on the right and left sides using the 5-point GAIS (1=Very Well Improved, 2=Well Improved, 3=Improved, 4=Not Improved, 5=Worsened State). The percentage of subjects assessed as Very Well Improved and Well Improved are reported.|Day 0, Day 14, Month 1, Month 6, Month 9, Month 12|All subjects with data for this outcome measure|||Percentage of Subjects|||Number
2599226|NCT02176421|Secondary|Percentage of Subjects Assessed by the Investigator as Very Well Improved or Well Improved on the 5-Point Global Aesthetic Improvement Scale (GAIS)|The Investigator evaluated the subjects global aesthetic improvement on right and left sides using the 5-point GAIS (1=Very Well Improved, 2=Well Improved, 3=Improved, 4=Not Improved, 5=Worsened State). The percentage of subjects assessed as Very Well Improved and Well Improved are reported.|Day 0, Day 14, Month 1, Month 6, Month 9, Month 12|All subjects with data for this outcome measure|||Percentage of Subjects|||Number
2599227|NCT02176421|Secondary|Injector Ease of Use on an 11-Point Scale|The injectors rated the ease of injection and ease of modeling of the product on an 11-point scale from 0 (extremely difficult) to 10 (extremely easy).|Day 0|All subjects with data for this outcome measure|||Scores on a Scale||Standard Deviation|Mean
2599228|NCT02176421|Secondary|Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the AIRS on the Right and Left Side|The Investigator evaluated the severity of skin crease and volume loss in the infra-orbital area on both the right and left sides on the 6-point AIRS ranging from 0 (least severe) to 5 (most severe).|Baseline, Day 0, Day 14, Month 6, Momth 9, Month 12|All subjects with data for this outcome measure|||Percentage of Subjects|||Number
2599229|NCT02176421|Primary|Percentage of Subjects With a ≥1 Grade Improvement From Baseline in Infra-Orbital Area on the Allergan Infra-Orbital Rating Scale (AIRS) on the Right and Left Side|The Investigator evaluated the severity of skin crease and volume loss in the infra-orbital area on both the right and left sides on the 6-point AIRS ranging from 0 (least severe) to 5 (most severe).|Baseline, Month 1|All subjects with data for this outcome measure|||Percentage of Subjects|||Number
2599230|NCT02176408|Secondary|Brain-derived Neurotrophic Factor (BDNF)|Blood samples (approximately 1 tsp) will be collected at baseline, week 4, week 8, and week 16 to test serum BDNF. Changes in resting BDNF levels were assessed. BDNF levels ranged from 14391 to 43020 ng/ml in this sample with higher levels indicating more BDNF.|Week 16|Amount of individuals who had BDNF data available at Week 16.|||ng/mL||Standard Deviation|Mean
2599231|NCT02176408|Secondary|7 Day Physical Activity Recall (PAR)|The PAR is is an interviewer-administered measure of physical activity behavior that will be used as a self-report validation measure of amount of physical activity completed. Metabolic equivalents (METs) of moderate and vigorous intensity activity are reported. METs of activity ranged from 0 to 1520 in this sample with higher numbers indicating more physical activity completed.|Week 16||||METs||Standard Deviation|Mean
2599232|NCT02176408|Secondary|Continuous Performance Test- Identical Pairs|Participants' attention will be assessed using the CPT which is a choice reaction time task which requires a subject to respond whenever two identical stimuli appear in a row within a sequence of rapidly flashed trials. Scores represent the average d' across 2 digit, 3 digit, and 4 digit trials. Average scores in this sample ranged from 1.76 to 4.24. Lower d' represents a better score.|Week 16||||score on a scale||Standard Deviation|Mean
2599233|NCT02176408|Secondary|Logical Memory|Participants will be read a story and asked to remember as many details as possible. Raw scores are reported with a range in the current sample from from 17 to 47 with higher scores indicating better memory performance.|Week 16||||score on a scale||Standard Deviation|Mean
2599234|NCT02176408|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)|The Q-LES-Q rates 16 aspects of quality of life, including physical health, mood, activities of daily living, and overall life satisfaction. Scores range from 14 to 70 with lower scores indicating worse quality of life.|Week 16||||score on a scale||Standard Deviation|Mean
2599235|NCT02176408|Secondary|Work and Social Adjustment Scale (WSAS)|The WSAS is a self-report scale of functional impairment attributable to an identified problem, in this case MDD. Scores range from 0 to 40 with higher scores indicating worse functioning. A WSAS score above 20 appears to suggest moderately severe or worse psychopathology. Scores between 10 and 20 are associated with significant functional impairment but less severe clinicalsymptomatology. Scores below 10 appear to be associated with subclinical populations.|Week 16||||score on a scale||Standard Deviation|Mean
2599236|NCT02176408|Secondary|Beck Depression Inventory-II (BDI-II)|The BDI is a widely used 21-item, self-report inventory designed to measure severity of depressive symptoms. Scores range from 0-63 with higher scores indicating worse depression. The following are severity norms for the measure: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression.|Week 16||||score on a scale||Standard Deviation|Mean
2599237|NCT02176408|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS is a 10-item clinician-rated measure of correlates of depression. Specifically, this questionnaire measures the following: sadness, tension, sleep, appetite, concentration, lassitude, numbness, pessimism, and suicidal ideation. The scale ranges from 0-60 with higher totals indicating worse depression. The following are norms for severity: 0 to 6 - normal/symptom absent; 7 to 19 - mild depression; 20 to 34 - moderate depression; and >34 - severe depression.|Week 16||||score on a scale||Standard Deviation|Mean
2599261|NCT02176291|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|"Measure of depression severity, range of 0-60~We calculated the mean change in depression severity for both groups using baseline MADRS and week 8 MADRS scores.~Greater mean change represents better outcome."|baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2599297|NCT02175979|Secondary|Anastomotic Leakage|number of patients developing anastomotic leakage|up to 6 weeks after surgery||||Participants|||Count of Participants
2599238|NCT02176356|Secondary|Change From Baseline in the Participant Satisfaction With Appearance of Periorbital Area|Participants assessed how their overall eye appearance has affected them over the past 7 days using the 9-item Periorbital Aesthetic Appearance Questionnaire (PAAQ). Possible responses to each question were: 0=Never (best), 1=Rarely, 2=Some of the time, 3=Most of the time and 4=All of the time with a total possible score of 0 to 36. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.|||score on a scale||Standard Deviation|Mean
2599239|NCT02176356|Secondary|Change From Baseline in the Investigator's Assessment of the Participant's Perioral Lines Severity|The investigator assessed the participant's perioral lines severity using the 4-Point Perioral Lines at Rest Severity Scale (POLSS) where: 0=None (no lines) [best], 1=Mild (few, shallow lines), 2=Moderate (some moderate lines) or 3=Severe (many deep lines or crevices)[worst]. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.|||score on a scale||Standard Deviation|Mean
2599240|NCT02176356|Secondary|Change From Baseline in the Investigator's Assessment of the Participant's Oral Commissures Severity|The investigator assessed the participant's oral commissure using the 4-Point Oral Commissure Severity Scale (OCSS) where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.|||score on a scale||Standard Deviation|Mean
2599241|NCT02176356|Secondary|Change From Baseline in the Investigator's Assessment of the Participant's Nasolabial Folds Severity|The investigator assessed the participants nasolabial folds severity using the 5-Point Nasolabial Fold Severity (NLFS) Scale where: 0=None (no wrinkles) [best], 1=Mild (shallow, just perceptible wrinkle), 2=Moderate (moderately deep wrinkle), 3=Severe (deep wrinkle) or 4= Extreme (very deep wrinkle). A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.|||score on a scale||Standard Deviation|Mean
2599242|NCT02176356|Secondary|Change From Baseline in the Investigator's Assessment of the Participant's Overall Mid-Face Volume Deficit Using the 6-Point MFVDS|The investigator assessed overall mid-face volume deficit using the Mid-face Volume Deficit Scale (MFVDS) where: 0=None (moon face; fullness) [best], 1=Minimal (flattening), 2=Mild (mild concavity), 3=Moderate (moderate concavity, 4=Significant (significant concavity) and 5=Severe (wasting) [worst]. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.|||score on a scale||Standard Deviation|Mean
2599243|NCT02176356|Secondary|Change From Baseline in Investigator's Global Eyelash Assessment Score (GEAS)|The investigator assessed the participant's eyelash prominence using the 4-point GEAS where: 1=Minimal (worst), 2=Moderate, 3=Marked and 4=Very Marked (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.|||score on a scale||Standard Deviation|Mean
2599244|NCT02176356|Secondary|Change From Baseline in Investigator's Assessment of the Severity of Crow's Feet Lines (CFLs) at Maximum Smile Using the FWS|The investigator assessed the severity of the participant's CFLs using the 4-point FWS where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.|||score on a scale||Standard Deviation|Mean
2599245|NCT02176356|Secondary|Change From Baseline in Investigator's Assessment of Severity of Glabellar Lines (GLs) at Maximum Frown Using the Facial Wrinkle Scale (FWS)|The investigator assessed the severity of the participant's GLs using the 4-point FWS where: 0=None, 1=Mild, 2=Moderate or 3=Severe. A negative change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.|||score on a scale||Standard Deviation|Mean
2599246|NCT02176356|Secondary|Participant's Self- Perception of Age (SPA)|Participants assessed SPA by answering the question: How do you think your facial appearance looks compared to your age today? Participants recorded how many years younger or older they thought their facial appearance made them look. A negative result indicates improvement (a younger appearance).|Baseline, Month 4|mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.|||years||Standard Deviation|Mean
2599247|NCT02176356|Secondary|Change From Baseline in Psychological Well-Being Using a 10-item Questionnaire|Participants assessed their psychological well-being with their facial appearance in mind using a 10-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4= Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.|||score on a scale||Standard Deviation|Mean
2599248|NCT02176356|Secondary|Change From Baseline in Social Confidence Using an 8-item Questionnaire|Participants assessed their social confidence with their facial appearance in mind in the past week using an 8-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4= Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.|||score on a scale||Standard Deviation|Mean
2599451|NCT02174510|Primary|Lurasidone VZ/F|VZ/F: Apparent volume of distribution at terminal phase (correlated with λz)|pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose||||L||Geometric Coefficient of Variation|Geometric Mean
2599249|NCT02176356|Secondary|Change From Baseline in Age Appraisal Using a Visual Analogue Scale (VAS)|Participants assessed how old they think they look compared to their actual age using a VAS by placing a mark on a number on a horizontal line where the far left of the line= -15 (look 15 years younger), 0=look current age, to the far right of the line=15 (look 15 years older). A positive change from Baseline indicates improvement.|Baseline, Month 4|Participants from the mITT population, all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment, with data available for analysis.|||years||Standard Deviation|Mean
2599250|NCT02176356|Secondary|Change From Baseline in Aging Appearance Using a 7-item Questionnaire|Participants rated how they look now using a 7-item questionnaire. Possible responses for each question are 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree or 4=Definitely agree. The responses were added across items and transformed to a Rasch score ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|mITT population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.|||score on a scale||Standard Deviation|Mean
2599251|NCT02176356|Primary|Change From Baseline in Satisfaction With Facial Appearance Overall Using a 10-item Questionnaire|Participants assessed their satisfaction with the way they look right now with their entire face in mind using a 10-item questionnaire. Possible responses to each question were: 1=Very dissatisfied, 2=Somewhat dissatisfied, 3-=Somewhat satisfied and 4=Very satisfied. The responses were added across items and transformed to a Rasch scale ranging from 0 (worst) to 100 (best). A positive change from Baseline indicates improvement.|Baseline, Month 4|Modified Intent-to-Treat (mITT) population included all participants who received all 3 treatments and had a Baseline and at least 1 post-treatment efficacy assessment.|||score on a scale||Standard Deviation|Mean
2599252|NCT02176343|Primary|Mean IOL Rotation|Lens axis orientation (position of the lens within the capsular bag) as indicated by indentations on the IOL was assessed during slit lamp examination. IOL rotation (the difference between the achieved lens axis orientation at visit and achieved axis placement at surgery) was measured in degrees. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated|||degrees||Standard Deviation|Mean
2599253|NCT02176343|Primary|Mean Best Corrected Distance Visual Acuity (BCDVA)|VA was tested monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m away from the subject. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated|||logMAR||Standard Deviation|Mean
2599254|NCT02176343|Primary|Mean Uncorrected Intermediate Visual Acuity|VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 53 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated|||logMAR||Standard Deviation|Mean
2599255|NCT02176343|Primary|Mean Uncorrected Near Visual Acuity|VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 40 cm on the nearpoint rod of the phoropter. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated|||logMAR||Standard Deviation|Mean
2599256|NCT02176343|Primary|Mean Uncorrected Distance Visual Acuity|Visual Acuity (VA) was tested monocularly without visual correction under photopic (well-lit) conditions using a 100% contrast ETDRS chart positioned 4 m from the subject. A +0.25 D spherical power additional lens was used to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated|||logMAR||Standard Deviation|Mean
2599257|NCT02176343|Primary|Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D|Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|This analysis population includes all subjects who provided informed consent and were determined eligible based upon the inclusion and exclusion criteria, having preoperative astigmatism > 1.00 D.|||percentage of subjects|||Number
2599258|NCT02176343|Primary|Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D|Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated|||percentage of subjects|||Number
2599259|NCT02176343|Primary|Mean Percent Reduction in Cylinder|Manifest refraction cylinder was measured monocularly (each eye separately) with best correction (phoropter or trial lenses) under photopic (well-lit) lighting conditions using a 100% contrast ETDRS chart at 4 meters (m) from the subject. Percent reduction in cylinder was calculated as the difference between the postoperative magnitude of manifest refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended reduction in cylinder [defined as the difference between the intended (from toric calculator) magnitude of the postoperative manifest refractive cylinder and the preoperative keratometric cylinder], multiplied by 100%. One eye (primary eye) contributed to the analysis.|Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)|As Treated|||percent change||Standard Deviation|Mean
2599260|NCT02176291|Secondary|Brief Symptom Inventory--Anxiety Subscale (BSI)|"Measure of Anxiety Theoretical Range 0-2.4 with lower numbers indicating a better outcome.~We calculated the mean change in anxiety for both groups using Phase 1 week 12 time point (baseline) and Phase 2 week 8 time point (final time point)."|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2599263|NCT02176226|Primary|GAD-7 (Generalized Anxiety Disorder Scale-7)|The GAD-7 is a self-administered 7 item instrument that uses some of the DSM-V criteria for GAD (General Anxiety Disorder) to identify probable cases of GAD along with measuring anxiety symptom severity. GAD-7 total score for the seven items ranges from 0 to 21. Higher values represent a worse outcome. Specifically, scores of 1-4 indicate minimal anxiety symptoms; 5-9 is mild anxiety symptoms; 10-14 is moderate anxiety symptoms; and 15-21 is severe anxiety symptoms.|Baseline, Week 4, and Week 8|Two participants missed week 4 assessment; and two participants missed week 8 assessment. This is why number analyzed in Week 4 row and Week 8 row differs from overall.|||units on a scale||Standard Deviation|Mean
2599264|NCT02176226|Primary|Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module|The PHQ-9 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-27. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-27 is severe.|Baseline, Week 4, and Week 8|Two participants missed week 4 assessment; and two participants missed week 8 assessment. This is why number analyzed in Week 4 row and Week 8 row differs from overall.|||units on a scale||Standard Deviation|Mean
2599265|NCT02176083|Primary|Hot Flash Frequency|Median number of daily hot flashes over 4th week of study|1 week||||daily hot flashes||Inter-Quartile Range|Median
2599266|NCT02176031|Secondary|Percentage Steroid Dose Was Reduced at Day 28, 56, and 100 in Comparison to Steroid Dose at First Administration of Natalizumab.|Median percentage steroid dose was reduced at Day 28, Day 56, and Day 100 in comparison to steroid dose at first administration of Natalizumab.|Day 28, 56, and 100||||percentage of steroid dose||Inter-Quartile Range|Median
2599267|NCT02176031|Secondary|Rate of GVHD Flares|Number of subjects who experienced graft-versus-host disease (GVHD) flares requiring therapy after initial complete response (CR) or partial response (PR) by day 28 after the first dose of Natalizumab.|by Day 28||||Participants|||Count of Participants
2599268|NCT02176031|Secondary|Overall Survival (OS) Rate|Overall survival (OS) is defined from the date of natalizumab infusion to death or censored at last clinical evaluation. OS was estimated using the Kaplan-Meier method.|2 years||||percentage of patients|||Number
2599269|NCT02176031|Secondary|GI aGVHD Response Rate|Gastrointestinal (GI) acute graft-versus-host disease (GVHD) Response is defined by complete response, very good partial response, or partial response in signs and symptoms of GI aGVHD.|Day 28, Day 56||||percentage of patients|||Number
2599270|NCT02176031|Secondary|Graft-verus-host Disease (GVHD) Response Rate|"Complete Response (CR) is defined as resolution of all signs and symptoms of acute GVHD.~Very Good Partial Response (VGPR) is defined by no rash or residual erythematous rash involving less than 25% of the body surface, and total serum bilirubin concentration less than 2 mg/dL or less than 25% of baseline at enrollment and tolerating food or enteral feeding, predominantly formed stools, no overt gastrointestinal bleeding or abdominal cramping, and no more than occasional nausea and vomiting.~Partial Response (PR) is defined as an improvement of one stage in one or more organs without progression in any other organ.~Non-response (NR) is defined as no reduction in any GVHD organ staging.~Progression is defined as either new organ involvement on day +8 or thereafter, or increased organ specific symptoms sufficient to increase the organ stage by one or more or the initiation of an additional GVHD agent.~Overall Response Rate (ORR) is the sum of CR, VGPR, and PR."|28 Days, 56 Days||||Participants|||Count of Participants
2599271|NCT02176031|Primary|GVHD-free Survival Rate|Graft-versus-host disease (GVHD) free survival is defined as achieving complete response without death or relapse or requiring secondary immunosuppressive therapy . Proportions are reported descriptively. GVHD-free survival was assessed using the Kaplan-Meier method.|Day 56||||percentage of patients|||Number
2599272|NCT02176018|Secondary|Adverse Events|Compare the number of adverse events in the Nuedexta arm vs. the placebo arm.|Baseline (Day 0) to Treatment Period Month 3 (Day 116)||||Number of Adverse Events|||Number
2599273|NCT02176018|Secondary|Headache Health Score|Headache Health Score at Visit 2 (Day 28), Visit 3 (Day 57), Visit 4 (Day 85), and Visit 5 (Day 116) for the Nuedexta arm and the placebo arm. The Headache Health Score is measured using a scale from 0 to 100, with higher scores indicating less headache impact on the subject's life.|Visit 2 (Day 28), Visit 3 (Day 57), Visit 4 (Day 85), and Visit 5 (Day 116)|Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets.|||units on a scale||Standard Deviation|Mean
2599274|NCT02176018|Secondary|Migraine Disability Assessment Scale (MIDAS)|"MIDAS scores at Visit 2 and Visit 5 (end of treatment period month 3). The MIDAS is a questionnaire consisting of five (5) how many days in the last 3 months... questions. Thus the range for the MIDAS is from, 0 to a maximum possible score 93 (31 days X 3 months). The MIDAS is scored according to the following:~0-5, MIDAS Grade I, Little or No Disability 6-10, MIDAS Grade II, Mild Disability 11-20, MIDAS Grade III, Moderate Disability 21+, MIDAS Grade IV, Severe Disability"|Visit 2 (Day 28) to Visit 5 (Day 116)|Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets.|||units on a scale||Standard Deviation|Mean
2599275|NCT02176018|Secondary|Acute Medication Use in Each Treatment Period Month|The average number of doses of acute medication taken at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm|Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)|Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets.|||Number of medication doses||Standard Deviation|Mean
2599276|NCT02176018|Secondary|50% Headache Reduction|The number of subjects with at least a 50% reduction in number of headache days comparing baseline to each visit (treatment period months 1, 2, and 3: 28 day for each month) in the Nuedexta arm vs. the placebo arm.|Baseline (Day 0) to Treatment Period Month 3 (Day 116)|Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure.|||Participants|||Count of Participants
2599452|NCT02174510|Primary|Lurasidone CL/F|CL/F：Apparent total clearance.|pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose||||L/h||Geometric Coefficient of Variation|Geometric Mean
2599277|NCT02176018|Secondary|Headache Duration in Each Treatment Period Month|The average headache duration (time of onset to pain free) at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache duration was measured in hours.|Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)|Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. Additionally, participants who were unavailable for the assessment at a particular time point were excluded. These criteria excluded 6 subjects in the Placebo arm and 3 subjects in the Nuedexta arm from the analysis data sets.|||Hours||Standard Deviation|Mean
2599278|NCT02176018|Secondary|Headache Severity in Each Treatment Period Month|The average headache severity at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache pain severity was measured on a scale from 1 = Mild, to 3 = Severe. Higher numbers indicating more severe headache pain.|Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)|Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. Additionally, participants who were unavailable for the assessment at a particular time point were excluded. These criteria excluded 6 subjects in the Placebo arm and 3 subjects in the Nuedexta arm from the analysis data sets.|||units on a scale||Standard Deviation|Mean
2599279|NCT02176018|Secondary|Migraine Days in Each Treatment Period Month|The average number of migraine days at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm.|Treatment Month 1, Month 2, and End of Treatment Period Month 3 (Day 116)|Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure.|||Number of Migraine days||Standard Deviation|Mean
2599280|NCT02176018|Secondary|Headache Days in Treatment Period Month 3|The average number of headache days at treatment period month 3 (28 day period) for the Nuedexta arm and the Placebo arm. Headache days were defined as any patient reported head pain during the prior 24 hour period.|End of Treatment Period Month 3 (Day 116)|Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure.|||Number of headache days||Standard Deviation|Mean
2599281|NCT02176018|Primary|Headache Days in Each Treatment Period Month|The average number of headache days at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache days were defined as any patient reported head pain during the prior 24 hour period.|Treatment Month 1, Treatment Month 2, and End of Treatment Period Month 3 (Day 116)|Randomized subjects were required to complete at least one full month of treatment period to be included in the analyses. These criteria excluded 6 subjects in the Placebo arm and 2 subjects in the Nuedexta arm from the analysis data sets. Thus, 37 participants were analyzed for this measure.|||Number of Headache days||Standard Deviation|Mean
2599282|NCT02176005|Secondary|Percentage of Subjects With Adverse Events Related to Study Product||From randomization to 37 days after the beginning of treatment||||% of subjects with at last 1 related AE|||Number
2599283|NCT02176005|Secondary|Number of Adverse Events (Including Abnormal Laboratory Findings) Related to Study Product||From randomization to 37 days after the beginning of treatment||||events related to study product|||Number
2599284|NCT02176005|Secondary|Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D5||D5: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h; 24h; 32h; 48h; 56h and 72h post-dose||||µg/mL||Standard Deviation|Mean
2599285|NCT02176005|Secondary|Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D1||D1: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h and 24h post-dose||||µg/mL||Standard Deviation|Mean
2599286|NCT02176005|Secondary|Moxifloxacin Plasma Pharmacokinetics: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D5||D5: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h; 24h; 32h; 48h; 56h and 72h post-dose||||µg/mL.h||Standard Deviation|Mean
2599287|NCT02176005|Secondary|Moxifloxacin Plasma Pharmacokinetics: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D1||D1: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h and 24h post-dose||||µg/mL.h||Standard Deviation|Mean
2599288|NCT02176005|Secondary|Moxifloxacin Fecal Pharmacokinetics: Area Under the Free Moxifloxacin Fecal Concentration-time Curve Over the Period Time From Beginning of Treatment to 37 Days After the Beginning of Treatment (AUC D1-D37)||D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16, D23, D30, D37||||μg/g.day||Standard Deviation|Mean
2599289|NCT02176005|Primary|Moxifloxacin Fecal Pharmacokinetics: Area Under the Free Moxifloxacin Fecal Concentration-time Curve Over the Period Time From Beginning of Treatment to 16 Days After the Beginning of Treatment (AUC D1-D16)||D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16||||μg/g.day||Standard Deviation|Mean
2599290|NCT02175979|Secondary|Health-related Quality of Life|Global Quality of life on a scale ranging from 0 to 100, with higher scores indicating higher level of functioning. The EORTC QLQ C-30 questionnaires are used|6 months after surgery||||units on a scale||Inter-Quartile Range|Median
2599291|NCT02175979|Secondary|Number of Patients Needing ICU Admission|number of patients needing ICU admission after surgery|up to 6 weeks after surgery||||Participants|||Count of Participants
2599292|NCT02175979|Secondary|Number of Patients Needing Additional Surgical, Radiological or Endoscopic Interventions|number of patients needing additional surgical, radiological or endoscopic interventions: All surgical complications are classified using the Clavien-Dindo classification. patients with a Clavien Dindo grade IIIa, IIIb, IVa, IVb, V complication had a surgical, radiological or endoscopic intervention.|up to 6 weeks after surgery||||Participants|||Count of Participants
2599293|NCT02175979|Secondary|C-reactive Protein (CRP)|the inflammatory response measured systemically (in blood): C-reactive protein (CRP)|up to 48 hours after surgery||||mg/L||Inter-Quartile Range|Median
2599294|NCT02175979|Secondary|Functional Recovery|Length of functional recovery in days, Functional recovery was defined as postoperative patients not receiving intravenous fluid who have adequate pain control, restoration ofindependent mobility, sufficient caloric intake, and no signs of active infection|up to 6 weeks after surgery||||days||Inter-Quartile Range|Median
2599453|NCT02174510|Primary|Lurasidone MRT|MRT：Mean residence time.|pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose||||h||Geometric Coefficient of Variation|Geometric Mean
2599299|NCT02175966|Secondary|Percentage of Participants Who Achieved SVR12 Associated With Interleukin-28B (IL28B) rs12979860 SNP Status (CC Genotype or Non-CC Genotype)|Percentage of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported.|Post-treatment Week 12|All included treated participants. Here, n' signifies number of participants analysed for specific category.|||Percentage of Participants|||Number
2599300|NCT02175966|Secondary|Percentage of Participants Who Achieved SVR12 Associated With HCV Geno Subtype 1a vs 1b|Percentage of Participants who Achieved SVR12 Associated with HCV geno subtype 1a or 1b|Post-treatment Week 12|All included treated participants. Here n' signifies number of participants analysed for specific category.|||Percentage of Participants|||Number
2599301|NCT02175966|Secondary|Percentage of Participants Who Achieved HCV RNA < LLOQ TND|Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24).|Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2, 4, 12 and 24|It included modified ITT treated population.|||Percentage of participants||95% Confidence Interval|Number
2599302|NCT02175966|Secondary|Percentage of Participants Who Achieved HCV RNA <LLOQ TD/TND|Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, and follow-up Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24).|Treatment Weeks 1, 2, 4 and 6; post-treatment Weeks 2 (SVR2), 4 (SVR4), 12 (SVR12) and 24 (SVR24)|It included modified Intent-to-treat treated population.|||Percentage of Participants||95% Confidence Interval|Number
2599303|NCT02175966|Primary|Number of Participants With Selected Grade 3/4 Laboratory Abnormalities|Grade 3/4 laboratory abnormalities (hematology, electrolyte, lipase, liver function, metabolic, renal function, urinalysis). The Week 24 data set was used to evaluate the Week-24 on-treatment safety. The cumulative data set was used to evaluate the safety while on treatment. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death.|From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)|Safety analysis population included participants who received at least 1 dose of study therapy.|||Participants|||Count of Participants
2599304|NCT02175966|Primary|Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment|SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect.|From signature of the informed consent until 4 weeks after last treatment administration.(Approximately 17 months)|Safety population included participants who received at least 1 dose of study therapy (DCV 3DAA or SOF).|||Participants|||Count of Participants
2599305|NCT02175966|Secondary|Percentage of Participants With End of Treatment Response (EOTR)|EOTR was defined as HCV RNA less than the lower limit of quantitation, target detected or not detected at end of treatment.|End of the treatment|All treated participants.|||Percentage of participants||95% Confidence Interval|Number
2599306|NCT02175966|Primary|Percentage of Participants With Sustained Virologic Response 12 (SVR12)|SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < lower limit of quantitation (LLOQ) target detected (TD) or not detected (TND) at post-treatment follow-up Week 12. Imputed SVR12 was based on Next Value Carried Backwards approach.|12 Weeks after treatment discontinuation (Follow-up Week 12)|It included treated participants (randomized participants) who received at least 1 dose of study therapy (DCV 3DAA or SOF).|||Percentage of participants||80% Confidence Interval|Number
2599307|NCT02175771|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Minute (FEV1) Over the 26-Week Treatment Period|"Spirometry measurements were obtained before the AM dose of study drug for the randomization visit (Day 1), at each of the treatment visits and at the early termination visit if applicable. At each visit where FEV1 was assessed, the highest acceptable results from each session were recorded.~The analysis is based on a mixed model for repeated measures (MMRM) with adjustment for baseline FEV1, sex, age, (pooled) investigational center, visit, treatment, and treatment-by-visit. An unstructured covariance matrix is used in the MMRM model."|Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, early termination visit if applicable|The full analysis set (FAS) included all participants in the intent-to-treat (ITT) population who received at least 1 dose of study drug and had at least 1 post-baseline trough FEV1 assessment.|||liters||Standard Error|Least Squares Mean
2599308|NCT02175771|Secondary|Analysis of 24-Hour Urine Cortisol Free Over the 26-Week Treatment Period|"Samples for 24-hour urine cortisol were collected at baseline (Day 1, pretreatment), and Weeks 14 and 26. For participants requiring early termination (ET), this evaluation was performed at the ET visit. For participants requiring ET for safety reasons, the visit was not delayed in order to collect the 24-hour urine cortisol.~The analysis is based on a mixed model for repeated measures (MMRM) model with adjustment for visit, treatment, and a treatment*visit interaction. The urine cortisol result is log transformed prior to analysis and the results are back transformed after modeling. An unstructured covariance matrix is used in the MMRM model."|Baseline (Day 1, pre-treatment), Weeks 14 and 26 and early termination visit if applicable|A urine cortisol analysis subset of the safety population was defined that included participants whose urine samples did not have confounding factors at any visit that could affect the interpretation of the results.|||mcg/24 hours||95% Confidence Interval|Geometric Mean
2599309|NCT02175771|Secondary|Shifts From Baseline to Endpoint in Electrocardiogram (ECG) Findings|A 12 lead ECG was conducted at the screening visit and week 26 or the early termination visit. A qualified physician at a central diagnostic center was responsible for interpreting the ECG. The worst post-baseline finding for the participant is summarized. Endpoint refers to the last observation carried forward.|Screening (Day -14), Endpoint (week 26 if study was completed)|Safety population of participants with both screening and endpoint ECGs|||Participants|||Count of Participants
2599336|NCT02175628|Secondary|Radiologist Preference|To compare radiologist preference of acoustic angiography to conventional b-mode ultrasound for each lesion characteristic (shape, margins and vascularity)|1.5 years|Preference Study not conducted because the imaging resolution was insufficient. The data were unable to be analyzed because we could not visualize the vessels to calculate this value. The system was unable to achieve the imaging resolution to visualize the vasculature.||||||
2599310|NCT02175771|Secondary|Participants With Potentially Clinically Significant Abnormal Vital Signs During the Treatment Period|"Data represents participants with potentially clinically significant (PCS) vital sign values during the Treatment period.~Significance criteria:~Systolic blood pressure - high: >=180 and increase >=20 mmHg~Systolic blood pressure - low: <=90 and decrease >=20 mmHg~Diastolic blood pressure - high: >=105 and increase of >=15 mmHg~Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg~Pulse - high: >=120 and increase of >= 15 beats/minute from baseline~Pulse - low: <=50 and decrease of >=15 beats/minute"|Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, Endpoint|Safety population of participants with a baseline and postbaseline vital sign value.|||Participants|||Count of Participants
2599311|NCT02175771|Secondary|Participants With Positive Swab Test Results for Oral Candidiasis|"Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at each visit by a qualified healthcare professional. Any visual evidence of oral candidiasis during the oropharyngeal exam was evaluated by obtaining and analyzing a swab of the suspect area.~This outcomes indicates how many participants had positive swab test results. The total number of participants who had oropharyngeal exams at each timepoint are specified in the timepoint field. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Participants with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol."|Baseline (Day 1 pre-treatment), Weeks 2, 6, 10, 14, 18, 22 26, Endpoint|Safety population|||Participants|||Count of Participants
2599312|NCT02175771|Primary|Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 26 of the Treatment Period|"Safety population which included all randomized participants who received at least 1 dose of randomized study drug.~The randomization allocation ratio of 3:1 (study drug: active comparator) should be taken into account when comparing treatment groups within treatment/strength cohorts"|||Participants|||Count of Participants
2599313|NCT02175758|Secondary|For the Treatment Phase, Palatability of SOF Granules at Day 1 as Assessed by the Percentage of Participants Able/Unable to Taste the SOF Oral Granules|Participants were asked if they were able to taste the SOF oral granules.|Day 1|Participants in the Safety Analysis Set who performed the palatability assessment were analyzed.|||percentage of participants|||Number
2599314|NCT02175758|Secondary|For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development|Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.|Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24|Female participants in the Safety Analysis Set with available data were analyzed.|||Participants|||Count of Participants
2599315|NCT02175758|Secondary|For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair|Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.|Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24|Female participants in the Safety Analysis Set with available data were analyzed.|||Participants|||Count of Participants
2599316|NCT02175758|Secondary|For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development|Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.|Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24|Male participants in the Safety Analysis Set with available data were analyzed.|||Participants|||Count of Participants
2599317|NCT02175758|Secondary|For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair|Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.|Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24|Male participants in the Safety Analysis Set with available data were analyzed.|||Participants|||Count of Participants
2599318|NCT02175758|Secondary|For the Treatment Phase, Change From Baseline in Weight||Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24|Participants in the Safety Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.|||kilograms||Standard Deviation|Mean
2599319|NCT02175758|Secondary|For the Treatment Phase, Change From Baseline in Height||Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24|Participants in the Safety Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.|||centimeters||Standard Deviation|Mean
2616818|NCT01987349|Primary|Number of Participants From Each Arm Who Received Influenza Vaccine Vaccine||Day 0 to 28||||Participants|||Count of Participants
2599320|NCT02175758|Secondary|For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization|ALT normalization was defined as ALT > the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit. One participant in the 3 to < 6 Years Old 12 Weeks group had ALT > ULN at Baseline, but had no other available data.|Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4|Participants in the Full Analysis Set with ALT > ULN at Baseline with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks. One participant in the 3 to < 6 Years Old 12 Weeks group had ALT > ULN at Baseline, but had no other available data.|||percentage of participants|||Number
2599321|NCT02175758|Secondary|For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment||Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)|Participants in the Full Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks.|||percentage of participants||95% Confidence Interval|Number
2599322|NCT02175758|Secondary|For the Treatment Phase, Change From Baseline in HCV RNA||Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)|Participants in the Full Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.|||log10 IU/mL||Standard Deviation|Mean
2599323|NCT02175758|Secondary|For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.|Up to Posttreatment Week 24|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2599324|NCT02175758|Secondary|For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough|Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment.|Up to 24 weeks|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2599325|NCT02175758|Secondary|For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)|SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2599326|NCT02175758|Secondary|For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2599327|NCT02175758|Secondary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase||Up to Day 7|Participants who were enrolled in the PK lead-in phase were analyzed.|||percentage of participants|||Number
2599328|NCT02175758|Secondary|For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA||Baseline; Weeks 1, 2, 4, 8, and 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)|Participants who were enrolled in the PK lead-in phase with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.|||log10 IU/mL||Standard Deviation|Mean
2599329|NCT02175758|Primary|For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set included all participants who were enrolled into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2599330|NCT02175758|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase||Up to 24 weeks|Safety Analysis Set included all participants who took at least 1 dose of study drug.|||percentage of participants|||Number
2599331|NCT02175758|Primary|For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF)|AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).|6 to < 18 years of age: predose, 0.5, 1, 2, 3, 4, 8, and 12 hours postdose on Day 7; 3 to < 6 years of age: predose, 2, 4, 8, and 12 hours postdose on Day 7|Intensive PK Analysis Set included all participants in the PK lead-in phase who received at least 1 dose of study drug and for whom at least 1 nonmissing PK concentration value, during the intensive sampling period, was reported by the PK laboratory.|||h*ng/mL||Standard Deviation|Mean
2599332|NCT02175745|Primary|Percent Agreement of 18F FDOPA PET With Pathology|For the subset of lesions where pathology is available (mainly biopsied lesions), the accuracy of 18F FDOPA PET as percent agreement with pathology will be calculated. If the number of biopsy positive lesions is at least 10, an estimate of sensitivity will be calculate; if the number of biopsy negative lesions is at least 10 an estimate of specificity will be calculated.|Up to 30 minutes post-injection (at time of scan)||||percentage of agreement (sensitivity)|||Number
2599333|NCT02175745|Primary|Number of Suspicious Lesions Identified by 18F FDOPA PET|The number of suspicious lesions will be identified by uptake of F18 FDOPA radiopharmaceutical using a positron emission tomography (PET) scan. Uptake of F-18 FDOPA is a measure of amino acid uptake and metabolism in tumors. Suspicious lesions will be visually identified by a board certified nuclear medicine physician.|Up to 30 minutes after injection of F18 FDOPA||||suspicious lesion(s)|||Number
2599334|NCT02175628|Secondary|Model-based Malignancy Score (Arbitrary Units)|To compare the model-based malignancy score to the acoustic angiography reader study|1.5 years|The data were unable to be analyzed because we could not visualize the vessels to calculate this value. The system was unable to achieve the imaging resolution to visualize the vasculature.||||||
2599335|NCT02175628|Secondary|Vessel Tortuosity (No Units)|To quantify vessel tortuosity metrics for the acoustic angiograph images, and to use these metrics to develop a model for predicting malignancy (a model-based malignancy score)|1.5 years|The data were unable to be analyzed because we could not visualize the vessels to calculate this value. The system was unable to achieve the imaging resolution to visualize the vasculature.||||||
2599337|NCT02175628|Secondary|Area Under the Curve (AUC) of Acoustic Angiography|The AUC of acoustic angiography compared to the AUC of b-mode ultrasound|1.5 years|The data were unable to be analyzed because we could not visualize the vessels to calculate this value. The system was unable to achieve the imaging resolution to visualize the vasculature.||||||
2599338|NCT02175628|Primary|Sensitivity and Specificity (Percentage)|To compare (using a reader study) the sensitivity and specificity of acoustic angiography to the sensitivity and specificity of conventional b-mode ultrasound in evaluation of breast lesions|1.5 years|The data were unable to be analyzed because we could not visualize the vessels to calculate this value. The system was unable to achieve the imaging resolution to visualize the vasculature.||||||
2599339|NCT02175472|Secondary|Change in the Score of the Epworth Sleepiness Scale From Baseline to Endpoint at 6 Months.|The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness to help in diagnosing sleep disorders. The ESS questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 (none) to 3 (worse) for eight different everyday situations. The total range is 0 - 24, with higher scores representing worse severity.|Six months||||units on a scale||Standard Error|Least Squares Mean
2599340|NCT02175472|Secondary|Change in the Score of the Parkinson's Disease Sleep Scale-Disturbed Sleep, From Baseline to Endpoint at 6 Months.|"The Parkinson's Disease Sleep Scale 2 (PDSS-2) is designed to assess nocturnal disability in Parkinson's disease. The PDSS-2 is a 15 question analog scale that ranks answers from 0 - 4, with 4 being worse. In addition to an overall assessment of sleep disability three aspects of sleep problems can be obtained; disturbed sleep (total of questions 1-3, 8 and 14), PD-specific nocturnal motor symptoms (total of questions 4-6, 12 and 13), and PD-specific nocturnal symptoms (Total of questions 7, 9-11 and 15). We selected the Disturbed Sleep subscale as a key secondary outcome measure. This subscale has a total range of 0 - 16, with 16 being more severe."|Six months||||units on a scale||Standard Error|Least Squares Mean
2599341|NCT02175472|Secondary|Change in the Score of the Parkinson's Disease Questionnaire - 39 From Baseline to Endpoint at 6 Months|"The 39 question Parkinson's Disease Questionnaire (PDQ-39) is a widely used patient reported rating scale in Parkinson's disease. Respondents affirm if they have experienced problems due to their disease using a five point scale from never (0 points) to always (4 points, or worse) in doing common activities. The PDQ-39 is comprised of 8 domains: mobility, emotion, activities of daily living, cognition, stigma, social support, communication, bodily discomfort. Total possible range of scores = 0 - 156~The questions are divided into eight measurement scales each comprising 3 to 10 questions. The scores for the questions in each scale are totaled and normalized to a scale of 0 - 100, that is equivalent to percent of maximum score. The scales are; Mobility (MOB): Q1-10; Activities of Daily Life (ADL): Q11-16; Emotional Well Being (EMO): Q17-22; Stigma (STI): Q23-26; Social Support (SOC): Q27-29; Cognitions (COG): Q30-33; Communication (COM) Q34-36; and Bodily Discomfort (BOD): Q37-39."|Six months||||units on a scale||Standard Error|Least Squares Mean
2599342|NCT02175472|Secondary|Change in the Clinical Global Impression- Improvement Scale (CGI-I) From Baseline to Endpoint at 6 Months.|"The Clinical Global Impression of Improvement is an assessment of the clinician's view of the patient's global functioning. Participants are ranked O at baseline. The CGI-I ranks 0 - 7, with 0 being much improved, 4 being neutral, and 7 being much worse."|Six months||||units on a scale||Standard Error|Least Squares Mean
2599343|NCT02175472|Primary|Change in the Combined Scores (Sum) of Parts I, II, and III of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (M (MDS-UPDRS) From Baseline to Endpoint at 6 Months.|"Part I: Non-motor impact of experiences of daily living. Part I has 13 questions,the first 6 are assessed by the examiner, and the remaining 7 are usually self assessed, but may include the patient's caregiver. Each question = 0-4, range= 0 - 65.~Part II: Motor Aspects of Experiences of Daily Living: This portion of the scale assesses the motor impact of PD on patients' experiences of daily living. There are 13 questions which are a component of the self-administered Patient Questionnaire.Each question = 0-4, range = 0-65.~Part III: Motor Examination: This portion of the scale assesses the motor signs of PD and is administered by the evaluator. There are 18 questions, however several questions have multiple parts which are also scored. Each question 0-4, Total range=0-132. Higher score=more severe"|Six Months||||units on a scale||Standard Error|Least Squares Mean
2599344|NCT02175368|Secondary|Clinical Quality|"The clinical quality of the restorations will be evaluated according to semi-quantitative clinical evaluation (SQUACE) criteria and compared at all time points and at the end of the study.~SQUACE is a published semi-quantitative method to evaluate the clinical success of dental restorations that is based on the commonly used USPHS criteria. The quality of the restoration is rated according to the SQUACE scale and classified as acceptable or not acceptable."|3 years||||Participants|||Count of Participants
2599345|NCT02175368|Primary|Number of Participants With Clinical Success|Clinical success is defined as no postoperative hypersensitivity and no loss of the restoration.|1 week||||Participants|||Count of Participants
2599346|NCT02175277|Primary|Number of Participants With Treatment-emergent Adverse Events|"Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, where Grade 1 indicates a mild AE, Grade 2 indicates a moderate AE, Grade 3 indicates severe or medically significant but not immediately life-threatening and Grade 4 indicates life-threatening consequences; urgent intervention indicated.~A serious adverse event was defined as an adverse event that met at least one of the following serious criteria:~fatal~life threatening~required in-patient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event The investigator assessed whether each adverse events was related to darbepoetin alfa."|From first dose of darbepoetin alfa to 30 days after last dose; the maximum treatment duration was 73 weeks.|All enrolled participants|||Participants|||Count of Participants
2599347|NCT02175225|Other Pre-specified|Number of Patients With Symptomatic Cerebral Edema|Edema accompanied by an unexplained increase of more than four points on the US National Institutes of Health Stroke Scale or a decrease of more than two points in Glasgow Coma Scale score during the first week after the intracerebral haemorrhage.|7 days|Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.|||Participants|||Count of Participants
2599362|NCT02175212|Secondary|Cause-specific Survival|Cause-specific survival included all deaths from prostate cancer or treatment complications, and deaths from unknown causes in patients with either active cancer or a previously documented relapse|5 years||||participants|||Number
2599348|NCT02175225|Other Pre-specified|Adverse Event of Special Interest: Number of Patients With Respiratory Compromise|Adverse event of special interest: Respiratory compromise of any cause, including acute respiratory distress syndrome, in hospital until day 7 or discharge [whichever was earlier]|7 days|Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.|||Participants|||Count of Participants
2599349|NCT02175225|Other Pre-specified|Adverse Event of Special Interest: Number of Patients With New Visual or Auditory Changes|Adverse event of special interest: development of new and unexplained visual or auditory changes after initiation of the study infusion|after initiation of study infusion|Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.|||Participants|||Count of Participants
2599350|NCT02175225|Other Pre-specified|Adverse Event of Special Interest: Number of Patients With Hypotension|Hypotension requiring medical intervention at any time during the study infusion that could not be explained by other causes|during the study infusion|Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.|||Participants|||Count of Participants
2599351|NCT02175225|Other Pre-specified|Adverse Event of Special Interest: Number of Patients With Allergic Reactions (During Infusion of Study Drug)|Adverse event of special interest: anaphylaxis at any time during the study infusion|during the study infusion|Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.|||Participants|||Count of Participants
2599352|NCT02175225|Other Pre-specified|Ordinal Distribution of Scores on mRS at 180 Days|The overall ordinal distribution of scores on mRS at 180 days in DFO- and placebo-treated subjects will be determined.|180 days|Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach.|||Participants|||Count of Participants
2599353|NCT02175225|Other Pre-specified|Ordinal Distribution of Scores on mRS at Day 90|The overall ordinal distribution of scores on mRS at 90 days in DFO- and placebo-treated subjects will be determined.|90 days|Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach.|||Participants|||Count of Participants
2599354|NCT02175225|Secondary|Proportion of Subjects With Good Outcome (mRS 0-2) in the Early vs. Delayed Treatment Time Windows|Analyses will be expanded to include an interaction between treatment and OTT window and the magnitude of the treatment effect, and corresponding confidence interval, will be estimated for each time window (<12 hours vs. >/= 12 hours) in order to explore the presence of a differential treatment effect in the OTT windows.|90 days|Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach. Subgroup analysis by Onset to treatment time window (<=12 hours vs >12 hours)|||Participants|||Count of Participants
2599355|NCT02175225|Secondary|Proportion of Patients With Modified Rankin Scale (mRS) Score 0-3 at 180 Days|Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-3 at 180 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome.|180 days|Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach.|||Participants|||Count of Participants
2599356|NCT02175225|Secondary|Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 180 Days|Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 180 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome.|180 days|Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach.|||Participants|||Count of Participants
2599357|NCT02175225|Secondary|Proportion of Patients With mRS Score 0-3 at 90 Days|"Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-3 at 90 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome.~Although mRS 0-3 is less favorable than the primary outcome of mRS 0-2, it would still be a desirable effect in patients with ICH given that no treatments exist to reduce disability."|90 days|Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach.|||Participants|||Count of Participants
2599358|NCT02175225|Primary|Number of Subjects With Serious Adverse Events Within 7 Days|Number of Subjects Experiencing Serious Adverse Events within 7 days of randomization|7 days|Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.|||Participants|||Count of Participants
2599359|NCT02175225|Primary|Number of Subjects Experiencing Serious Adverse Events|Number of subjects experiencing Serious adverse events at any time from randomization through day 90|90 days|Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated.|||Participants|||Count of Participants
2599360|NCT02175225|Primary|Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days|The primary outcome measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 90 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome.|90 days|Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach.|||Participants|||Count of Participants
2599361|NCT02175212|Secondary|Late Toxicity|"Defined as the maximal rectal, urinary and cardiovascular (CV) toxicity per patient more than 90 days after completion of RT.~Scoring scales used were the radiation morbidity scoring criteria of the European Organization for Research and Treatment of Cancer-Radiation Therapy Oncology Group (EORTC/RTOG) and the Common Terminology Criteria for Adverse Events (CTCAEs) v 3.0 for the remained toxicity.~CV events were defined according to the World Health Organization criteria"|5 years||||percentage of patients|||Number
2599364|NCT02175212|Secondary|Metastasis Free Survival: Estimated Percentage of Participants With Metastasis-free Survival at 5 Years|Metastasis free survival: defined as the time from inclusion in the study (randomization) until the appearance of distant metastases: a positive result in any of the tests performed (scintigraphy, chest radiography, thorax, abdominal and pelvic CT and MRI).|5 years||||percentage of participants||95% Confidence Interval|Number
2599365|NCT02175212|Primary|Biochemical Disease Free Survival: Estimated Percentage of Participants With Biochemical Disease-free Survival at 5 Years|Biochemical relapse was defined as the time from inclusion in the study (randomization) until the patient meets criteria for Biochemical failure (Phoenix criteria: PSA nadir plus 2 ng/ml).|5 years||||percentage of patients||95% Confidence Interval|Number
2599366|NCT02175199|Secondary|Lens Comfort 1-10 Scale Response|"Subject was instructed, Please rate your comfort with the study lenses, using a scale from 1-10, where 1=poor and 10=excellent. Both eyes were rated together."|Day 30|This analysis population includes all randomized subjects with data at visit excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).|||units on a scale||Standard Deviation|Mean
2599367|NCT02175199|Secondary|Lens Comfort Likert Response at Day 14|"Subject indicated agreement with the following statement, These lenses provided the same excellent comfort at the end of two weeks as they did at the beginning of the two weeks using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure is prespecified for the AIR OPTIX COLORS arm only."|Day 14|This analysis population includes all randomized subjects with data at visit excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).|||percentage of subjects|||Number
2599368|NCT02175199|Primary|Lens Comfort Likert Response at Day 30|"Subject indicated agreement with the following statement, These lenses provided the same excellent comfort at the end of the month as they did at the beginning of the month using a 4-point Likert scale, where 1=Strongly disagree, 2=Disagree; 3=Agree; 4=Strongly agree. The Top 2 responses (agree, strongly agree) were calculated and reported as a percentage of all responses. Both eyes were rated together. This outcome measure was prespecified for the AIR OPTIX COLORS arm only."|Day 30|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).|||percentage of subjects|||Number
2599369|NCT02175121|Secondary|Apparent Clearance (CL/F)|Apparent oral clearance of PF-06291874.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2599370|NCT02175121|Secondary|Minimum Plasma Concentration (Cmin)|Minimum PF-06291874 plasma concentration.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2599371|NCT02175121|Secondary|Area Under the Concentration-Time Profile From Zero to Time Tau (AUCtau) (Where Tau=24 Hours)|Area under the PF-06291874 plasma concentration-time profile from time zero to time tau, the dosing interval, where tau=24 hours.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2599372|NCT02175121|Secondary|Time to Reach Cmax (Tmax)|Time to maximum PF-06291874 plasma concentration.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||hour (hr)||Full Range|Median
2599373|NCT02175121|Secondary|Maximum Plasma Concentration (Cmax)|Maximum PF-06291874 plasma concentration.|Day 28 (samples taken at 0, 2, 4, 8 and 24 hours after Day 28 dose)|The PK analysis set was defined as all participants who received at least 1 dose of study medication. Samples for participants taking placebo were not analyzed. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2599374|NCT02175121|Secondary|Percent Change From Baseline in Lipoprotein A|The Lipoprotein A percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
2599375|NCT02175121|Secondary|Percent Change From Baseline in Apolipoprotein B100|The Apolipoprotein B100 was calculated as the difference between total Apolipoprotein B and Apolipoprotein B48 and analyzed the percent change from baseline (defined as mean of Day 0 and Day 1) on Day 28 (mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
2599376|NCT02175121|Secondary|Percent Change From Baseline in LDL Size|The LDL size percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
2608995|NCT02071290|Primary|Endothelial Injury (Hyaluronan)|Change in plasma levels of endothelial injury marker Hyaluronan over 24 hours from Admission|0 (Admission), 1, 3, 24 hours||||ng/mL||Inter-Quartile Range|Median
2599377|NCT02175121|Secondary|Percent Change From Baseline in Total LDL Particles|Total LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
2599378|NCT02175121|Secondary|Percent Change From Baseline in Very Small LDL Particles|Very small LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
2599379|NCT02175121|Secondary|Percent Change From Baseline in Small LDL Particles|Small LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
2599380|NCT02175121|Secondary|Percent Change From Baseline in Medium Small LDL Particles|Medium small LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
2599381|NCT02175121|Secondary|Percent Change From Baseline in Large LDL Particles|Large LDL particles percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
2599382|NCT02175121|Secondary|Percent Change From Baseline in Oxidized LDL|Oxidized LDL percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 28 (the mean of Days 28 and 29).|Baseline and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
2599383|NCT02175121|Secondary|Percent Change From Baseline in Non-HDL-C|Non-HDL-C percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
2599384|NCT02175121|Secondary|Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)|HDL-C percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
2599385|NCT02175121|Secondary|Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)|LDL-C percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
2599386|NCT02175121|Secondary|Percent Change From Baseline in Total Cholesterol|Total cholesterol percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
2599387|NCT02175121|Secondary|Percent Change From Baseline in Triglycerides|Triglycerides percent change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in percent change from Baseline when different, represents the available number of participants for analysis at post-baseline days.|||% (percent change)||Standard Deviation|Mean
2599388|NCT02175121|Secondary|Change From Baseline in Fasting Plasma Glucose|Fasting plasma glucose response change from baseline (defined as the mean of Day 0 and Day 1 pre-dose) on Day 14, and the mean of Days 28 and 29.|Baseline, Day 14 and the mean of Days 28 and 29|The FAS was used in the analysis of the PD parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. N in change from Baseline when different, represents the available number of participants for analysis at post-baseline days.|||mg/dL||Standard Deviation|Mean
2599408|NCT02174848|Primary|Number of Participants With Adverse Events|Safety and tolerability were assessed based on changes in: frequency of adverse events (AEs), frequency of serious adverse events (SAEs), and discontinuation due to AEs. No statistical comparison between the groups was conducted as all participants received the same study product.|18 months|Safety population|||Participants|||Count of Participants
2599389|NCT02175121|Secondary|Change From Baseline in Mean Daily Glucose|The mean daily glucose was determined from the area under the concentration (AUC) of the glucose concentrations measured at nominal times 0, 0.5, 1, 1.5, 2, 4, 6, 10, 12, 15 and 24 hours post dose. Mean daily glucose change from baseline (defined as Day 0) on Day 28.|Baseline and Day 28|The full analysis set (FAS) was used in the analysis of the pharmacodynamic (PD) parameters. The FAS was defined as all subjects randomized and who received at least 1 dose of randomized treatment. Number of participants analyzed represents the available number of participants for analysis at post-baseline days.|||mg/dL||Standard Deviation|Mean
2599390|NCT02175121|Primary|Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern|ECG criteria of potential clinical concern were 1), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval): >=140 msec; >=50% increase from baseline; 2), the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=300 milliseconds (msec); >=25 percent (%) increase when baseline >200 msec; or increase >=50% when baseline less than or equal to (<=)200 msec; 3), time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >=500 msec; increase from baseline >=30 - <60, >=60 msec.|Baseline up to 10-14 days after last dose of study drug, up to 42 days|The safety analysis set was defined as all participants who received at least 1 dose of study drug.|||participants|||Number
2599391|NCT02175121|Primary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern|Vital Signs included seated supine systolic and diastolic blood pressure (BP) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from baseline, diastolic <50 mm Hg; 2), pulse rate <40 or greater than (>) 120 beats per minute (bpm).|Baseline up to 10-14 days after last dose of study drug, up to 42 days|The safety analysis set was defined as all participants who received at least 1 dose of study drug.|||participants|||Number
2599392|NCT02175121|Primary|Number of Participants With Laboratory Test Abnormalities|The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis, and some other tests.|Baseline up to 10-14 days after last dose of study drug, up to 42 days|The safety analysis set was defined as all participants who received at least 1 dose of study drug.|||participants|||Number
2599393|NCT02175121|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), or Serious Adverse Events (SAEs), or Hypoglycemic Adverse Events (HAE) or Withdrawals Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. An HAE was identified by characteristic symptoms or blood glucose levels. TEAEs are events between first dose of study drug and up to 10-14 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 10-14 days after last dose of study drug, up to 42 days|The safety analysis set was defined as all participants who received at least 1 dose of study drug.|||participants|||Number
2599394|NCT02174861|Secondary|CHU Substudy: Number of Participants With Adverse Events|"Adverse events were graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.~Injection site reactions were derived from a Medical Dictionary for Regulatory Activities (MedDRA) query using a list of pre-specified preferred terms.~An adverse device effect (ADE) is any adverse event related to the use of a medical device."|From first dose of erenumab in the CHU substudy to 28 days after last dose of erenumab in the CHU substudy; up to 12 weeks.|All randomized participants who received at least one dose of erenumab in the CHU substudy.|||Participants|||Count of Participants
2599395|NCT02174861|Secondary|Change From Study 20120295 Baseline in Cumulative Monthly Headache Hours|"The cumulative duration of any qualified headache between monthly doses of study drug regardless of acute treatment use.~A qualified headache was defined as follows:~a qualified migraine headache (including an aura-only event that is treated with acute migraine-specific medication), or~a qualified non-migraine headache, which is a headache that lasted continuously for ≥ 4 hours and was not a qualified migraine headache, or~a headache of any duration for which acute headache treatment was administered."|4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255|Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The analysis includes participants with available data at each time point.|||hours / month||Standard Deviation|Mean
2599396|NCT02174861|Secondary|Change From Study 20120295 Baseline in Monthly Acute Migraine-Specific Medication Treatment Days|Monthly acute migraine-specific medication treatment days is the number of days on which migraine specific medications were used between monthly doses of study drug. Migraine-specific medications includes two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications.|4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40 and 52 visits of Study 20130255|Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The analysis includes participants with available data at each time point.|||acute migraine treatment days / month||Standard Deviation|Mean
2599409|NCT02174731|Secondary|Time-To-First Administration of RBC Transfusion as Rescue Therapy|Time-to-first RBC transfusion as rescue therapy was calculated as (date of first occurrence of any RBC transfusion as rescue therapy, or date of censoring if no event had occurred) - (date of first dose of IP) + 1. Event rate was calculated as (number of participants with event) divided by (the total number of days at risk for event across all participants in given group divided by 365.25) multiplied by 100. The event rate is presented for participants with events.|Baseline (Day 1, Week 0) up to EOS (4 weeks after the treatment period)|The on-treatment+3 days safety analysis set included all participants who received at least 1 dose of randomized IP, except for those excluded from analysis. Participants were censored at 3 days after the last administration of the IP.|||events per 100 participant years|||Number
2599397|NCT02174861|Secondary|Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Study 20120295 Baseline|"A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the 4 weeks prior to each study visit.~At least a 50% reduction from baseline (of study 20120295) in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the 4 weeks prior to each study visit * 100 / baseline monthly migraine days was less than or equal to -50%."|4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40 and 52 visits of Study 20130255|Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The analysis includes participants with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
2599398|NCT02174861|Secondary|Change From Study 20120295 Baseline in Monthly Migraine Days|"A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura.~The change from baseline in monthly migraine days was calculated as the number of migraine days during the 4 weeks prior to each study visit - the number of migraine days during the 4-week baseline phase."|4-week baseline phase of Study 20120295 and the 4 weeks prior to the week 4, 8, 12, 24, 40, and 52 visits of Study 20130255|Enrolled participants who received at least one dose of erenumab and had at least one change from baseline measurement in monthly migraine day in study 20130255. The number of participants analyzed includes participants with available data at each time point.|||migraine days / month||Standard Deviation|Mean
2599399|NCT02174861|Primary|CHU Substudy: Number of Participants Able to Administer a Full Dose of Erenumab in Home-use|At the CHU substudy day 28 and day 56 visits, the site provided erenumab 140 mg to participants to self-administer at home on the following day. Study site staff then called the participants and asked if they administered a full, partial, or no dose of erenumab. A full dose was defined when the entire volume of both prefilled syringes or autoinjector/pens were injected.|Day 29 (week 4) and day 57 (week 8) of the substudy|All randomized participants who received at least 1 dose of erenumab in the CHU substudy.|||Participants|||Count of Participants
2599400|NCT02174861|Primary|Number of Participants With Adverse Events|Adverse events (AEs) were graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, where Grade 1 = mild AE, asymptomatic or mild symptoms; Grade 2 = Moderate AE; Grade 3 = Severe or medically significant but not immediately life-threatening; Grade 4 = Life-threatening consequences; urgent intervention indicated; Grade 5 = Death related to AE.|From first dose of erenumab in extension study 20130255 to the end of the 12-week safety follow-up period (up to 64 weeks).|All enrolled participants who received at least 1 dose of erenumab|||Participants|||Count of Participants
2599401|NCT02174848|Secondary|Proportion of Patients With Improved or Unchanged PGI-I Score|Patients were deemed to be responders if their PGI-I score at the end of the study indicated that they felt they had either improved or remained unchanged from baseline|Month 18 of each study||||Participants|||Count of Participants
2599402|NCT02174848|Secondary|Patient Global Impression of Improvement (PGI-I) Comparison of DFP-DFP Patients Across Studies|The Patient Global Impression of Improvement (PGI-I) is a global index used to rate the response of a condition to a therapy. Patients were asked at each post-baseline visit to rate their overall condition since the start of the extension study on a 7-point rating scale: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Month 18 of each study||||score on a scale||Standard Deviation|Mean
2599403|NCT02174848|Secondary|Patient Global Impression of Improvement (PGI-I) Comparison of Placebo-DFP Patients Across Studies|The Patient Global Impression of Improvement (PGI-I) is a global index used to rate the response of a condition to a therapy. Patients were asked at each post-baseline visit to rate their overall condition since the start of the extension study on a 7-point rating scale: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Month 18 of each study||||score on a scale||Standard Deviation|Mean
2599404|NCT02174848|Secondary|Proportion of Patients With Improved or Unchanged BAD Score|Patients were deemed to be responders if their BAD total score either improved or remained unchanged from baseline, with baseline being the start of each study for the placebo-DFP group and the start of the initial study for the DFP-DFP group|Month 18 of each study||||Participants|||Count of Participants
2599405|NCT02174848|Secondary|Change in Score on the BAD Scale -- Comparison of DFP-DFP Patients Across Studies|The Barry-Albright Dystonia (BAD) scale is an instrument for rating the severity of dystonia in eight body regions. The individual scores are summed to provide a total score that ranges from 0 to 32; the higher the score, the more severe the dystonia. Patients were assessed for the change in total BAD score over the course of the study.|Baseline and Month 18 of each study||||score on a scale||Standard Deviation|Mean
2599406|NCT02174848|Secondary|Change in Score on the BAD Scale -- Comparison of Placebo-DFP Patients Across Studies|The Barry-Albright Dystonia (BAD) scale is an instrument for rating the severity of dystonia in eight body regions. The individual scores are summed to provide a total score that ranges from 0 to 32; the higher the score, the more severe the dystonia. Patients were assessed for the change in total BAD score over the course of each study.|Baseline and Month 18 of each study||||score on a scale||Standard Deviation|Mean
2599407|NCT02174848|Secondary|Change in Score on the BAD Scale -- Comparison of Treatment Groups Over Each Study|The Barry-Albright Dystonia (BAD) scale is an instrument for rating the severity of dystonia in eight body regions. The individual scores are summed to provide a total score that ranges from 0 to 32; the higher the score, the more severe the dystonia. Patients were assessed for the change in total BAD score over the course of both the initial study (during which one group received placebo and the other received deferiprone) and the extension study (during which both groups received deferiprone).|Baseline and Month 18 of each study||||score on a scale||Standard Deviation|Mean
2599442|NCT02174523|Primary|Lurasidone CL/F||pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose|All subjects with evaluable PK data were included in PK data analysis.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2599410|NCT02174731|Secondary|Mean Monthly IV Iron Use From Week 36 to End of Study (EOS)|Oral iron supplementation was allowed for both treatment groups without restriction. Oral iron was recommended for dietary supplementation to support erythropoiesis and as the first line treatment for prevention and treatment of iron deficiency, unless the participant was intolerant to this route of treatment. In participants receiving roxadustat, the Investigator was allowed to initiate the use of an approved IV iron supplement if a participant's Hb value had not sufficiently responded to 2 or more dose increases of the IP, and ferritin <100 nanogram per milliliter (ng/mL) or transferrin saturation (TSAT) <20%. IP treatment was allowed to continue during IV iron administration. Discontinuation of IV iron supplementation was recommended once the participant was no longer considered to be iron deficient (ferritin >100 ng/mL and TSAT >20%).|Week 36 to EOS (4 weeks after the treatment period)|The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis.|||milligram per month||Standard Deviation|Mean
2599411|NCT02174731|Secondary|Mean Change in Hb From Baseline to the Participant's Mean Level Between Week 28 to Week 52 in Participants With Baseline High-Sensitivity C-Reactive Protein (hsCRP) Greater Than the Upper Limit of Normal (ULN)|Baseline hsCRP was quantified from stored biomarker samples obtained at randomization. Baseline Hb is defined as the mean of the three last central laboratory Hb values from the screening and randomization visits. Changes in Hb from baseline to mean value during Weeks 28 to 52 in participants with baseline hsCRP >ULN was analyzed using a MAR based multiple imputation ANCOVA. Baseline Hb was used as a covariate and treatment group, CV history, geographic region and dialysis duration as fixed effects. The adjusted LS mean estimates of change from baseline during Week 28 to Week 52 are presented.|Baseline (Day 1, Week 0), Week 28 to 52|The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. Only participants who consented to the use of donated biomarker samples and had baseline hsCRP >ULN were included in the analysis.|||g/dL||Standard Error|Least Squares Mean
2599412|NCT02174731|Secondary|Mean Change in Low-Density Lipoprotein (LDL) Cholesterol From Baseline to Week 24|Baseline LDL was defined as the last result obtained prior to randomization. Mean changes in LDL cholesterol from baseline to Week 24 was analysed using ANCOVA. Baseline Hb and baseline LDL were used as covariates and treatment groups, CV history, geographic region and dialysis duration as fixed effects. The adjusted LS mean estimates of change from baseline to Week 24 are presented.|Baseline (Day 1, Week 0) to Week 24|The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis.|||millimole per liter||Standard Error|Least Squares Mean
2599413|NCT02174731|Secondary|Proportion of Total Time of Hb Within the Interval of 10 to 12 g/dL From Week 28 to Week 52|The proportion of total time was computed as follows: For each participant, the recorded Hb values were first linearly interpolated between measurements. The time this interpolated curve was within 10-12 g/dL was computed and subsequently divided by the time between the measurement from Week 28 to 52. The difference between roxadustat and epoetin alfa were compared using ANCOVA. Baseline Hb was used as a covariate and the treatment groups, CV history, geographic region and dialysis duration as fixed effects.|Week 28 to 52|The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. Participants without any Hb measurements from Week 28 were not included in the analysis.|||proportion of total time||Standard Error|Least Squares Mean
2599414|NCT02174731|Secondary|Proportion of Total Time of Hb Within the Interval of >=10 g/dL From Week 28 to Week 52|The proportion of total time was computed as follows: For each participant, the recorded Hb values were first linearly interpolated between measurements. The time this interpolated curve was >=10 g/dL was computed and subsequently divided by the time between the measurements from Week 28 to Week 52. The difference between roxadustat and epoetin alfa were compared using ANCOVA. Baseline Hb was used as a covariate and the treatment groups, CV history, geographic region and dialysis duration as fixed effects.|Week 28 to 52|The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. Participants without any Hb measurements from Week 28 were not included in the analysis.|||proportion of total time||Standard Error|Least Squares Mean
2599415|NCT02174731|Secondary|Change in Hb From Baseline to the Mean Level During the Evaluation Period (Week 28 to Week 36) Without Having Received Rescue Therapy Within 6 Weeks Prior to and During the 8‑Week Evaluation Period|Baseline Hb was defined as the mean of the three last central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to the participants mean level from Week 28 to Week 36,without having received rescue therapy within 6 weeks prior to and during this 8 week evaluation period was analysed using Mixed Model of Repeated Measures (MMRM). Baseline Hb was used as a covariate and treatment group, CV history, geographic region and dialysis duration as fixed effects. The adjusted LS mean estimates of change from baseline during Week 28 to Week 36 are presented for participants that did not receive rescue therapy within 6 weeks prior to and during this 8‑week evaluation period.|Baseline (Day 1, Week 0), Week 28 to 36|The Per Protocol Set (PPS) included all randomized participants without important protocol deviations who had received at least 8 weeks of study treatment and had valid corresponding Hb measurements. Participants from the PPS, with data available for analysis are presented.|||g/dL||Standard Error|Least Squares Mean
2599416|NCT02174731|Primary|Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52|Baseline Hb was defined as the mean of the three last central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to the participants mean level from Week 28 to Week 52 was analyzed using a missing at random (MAR) based multiple imputation Analysis of Covariance (ANCOVA). Baseline Hb was used as a covariate and treatment group, cardiovascular (CV) history, geographic region and dialysis duration as fixed effects. The adjusted least squares (LS) mean estimates of change from baseline during Week 28 to Week 52 are presented.|Baseline (Day 1, Week 0), Week 28 to 52|The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis.|||g/dL||Standard Error|Least Squares Mean
2599443|NCT02174523|Primary|Lurasidone MRT||pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose|All subjects with evaluable PK data were included in PK data analysis.|||h||Geometric Coefficient of Variation|Geometric Mean
2599417|NCT02174627|Secondary|Mean Change From Baseline in SF-36 Physical Functioning Sub-Score From Week 12 to Week 28|SF-36 is a QoL scale comprising 8 domains of health status: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Each domain score is on a scale from 0-100 (worst health possible to best health possible); higher scores indicate better health status. Mean change in SF-36 Physical Functioning sub-score from baseline to mean from Week 12 to Week 28 was analyzed using a MMRM with terms for baseline score, treatment group, baseline Hb, baseline eGFR, CV history, geographic region, visit and treatment-by-visit interaction as fixed effects and participant as random effect. The adjusted LS mean estimates of change from baseline to mean score from Week 12 to Week 28 are presented.|Baseline (Day 1, Week 0) and Week 12 to Week 28.|The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis.|||scores on a scale||Standard Error|Least Squares Mean
2599418|NCT02174627|Secondary|Annual Rate of eGFR Change From Baseline Prior to the Initiation of Dialysis or Kidney Transplant|Baseline eGFR was defined as the mean of all available central laboratory values prior to or at randomization. Rate of change in eGFR from baseline during the entire treatment period (in millilitres/minute/1.73 meters squared/years [mL/min/1.73m^2/years]) was estimated using a random effects model using all post-baseline eGFR values prior to initiation of dialysis/transplant. Baseline eGFR, baseline Hb, geographic region, CV history, treatment group and post-baseline eGFR measurement time were used as fixed effects and participant and time (years) as random effects, ie, random intercept and slope.|Baseline (Day1, Week 0) up to EOS visit (4 weeks after the treatment period), with treatment duration up to 4 years.|The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis.|||eGFR rate (mL/min/1.73m^2/years)|||Number
2599419|NCT02174627|Secondary|Mean Change From Baseline in Short Form 36 (SF-36) Vitality Sub-Score From Week 12 to Week 28|SF-36 is a Quality of Life (QoL) scale comprising 8 domains of health status: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health. Each domain score is on a scale from 0-100 (worst health possible to best health possible); higher scores indicate better health status. Mean change in SF-36 Vitality sub-score from baseline to mean from Week 12 to Week 28 was analyzed using a mixed model for repeated measures (MMRM) with terms for baseline score, treatment group, baseline Hb, baseline eGFR, CV history, geographic region, visit and treatment-by-visit interaction as fixed effects and participant as random effect. The adjusted LS mean estimates of change from baseline to mean score from Week 12 to Week 28 are presented.|Baseline (Day 1, Week 0) and Week 12 to Week 28.|The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis.|||scores on a scale||Standard Error|Least Squares Mean
2599420|NCT02174627|Secondary|Time-To-First Instance of Receiving a RBC Transfusion As Rescue Therapy|Time-to-first RBC rescue therapy was calculated as (date of first RBC rescue therapy, or date of censoring if no rescue therapy was taken) minus (date of first dose of IP) +1. Event rate was calculated as (number of participants with event) divided by (the total number of days at risk for event across all participants in given group divided by 365.25) multiplied by 100. The event rate is presented for participants with events.|Baseline (Day1, Week 0) up to EOS visit (4 weeks after the treatment period) (or up to date of first RBC rescue therapy), with treatment duration up to 4 years.|The OT+28 analysis set included all participants who received at least 1 dose of randomized IP, except for those excluded from analysis. Participants were censored 28 days after last intake of IP.|||Events per 100 participant years|||Number
2599421|NCT02174627|Secondary|Time-To-First Instance of Receiving IV Iron, RBC Transfusion or Erythropoietin Analogue as Rescue Therapy|Time-to-first rescue therapy (IV iron, RBC transfusion or erythropoietin analogue) was calculated as (date of first rescue therapy, or date of censoring if no rescue therapy was taken) minus (date of first dose of IP) +1. Event rate was calculated as (number of participants with event) divided by (the total number of days at risk for event across all participants in given group divided by 365.25) multiplied by 100. The event rate is presented for participants with events.|Baseline (Day1, Week 0) up to End of Study (EOS) visit (4 weeks after the treatment period) (or up to date of first rescue therapy), with treatment duration up to 4 years.|The on-treatment plus 28 days (OT+28) analysis set included all participants who received at least 1 dose of randomized IP, except for those excluded from analysis. Participants were censored 28 days after last intake of IP.|||Events per 100 participant years|||Number
2599422|NCT02174627|Secondary|Mean Change in Low-Density Lipoprotein (LDL) Cholesterol From Baseline to Week 24|Baseline LDL was defined as the last result obtained prior to randomization. Mean changes in LDL cholesterol from baseline to Week 24 was analyzed using an ANCOVA model with baseline LDL, baseline Hb and baseline eGFR as covariates, and CV history, geographic region and treatment group as fixed effects. The adjusted LS mean estimates of change from baseline to Week 24 are presented.|Baseline (Day 1, Week 0) and Week 24|The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis.|||millimole per liter||Standard Error|Least Squares Mean
2599423|NCT02174627|Secondary|Proportion of Total Time of Interpolated Hb Values Within the Interval of 10 to 12 g/dL From Week 28 to Week 52|Proportion of total time of interpolated Hb values within the interval of 10 to 12 g/dL was calculated as the time the linearly interpolated curve between measurements were within 10 to 12 g/dL divided by the time between measurements from Week 28 to Week 52. Proportion of total time was analyzed using an ANCOVA model with baseline Hb and baseline eGFR as covariates, and CV history, geographic region and treatment group as fixed effects. The adjusted LS mean estimates of change from Week 28 to Week 52 are presented.|Week 28 up to Week 52.|The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. Participants without any Hb measurements from Week 28 were not included in the analysis.|||proportion of total time||Standard Error|Least Squares Mean
2599444|NCT02174523|Primary|Lurasidone t1/2||pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose|All subjects with evaluable PK data were included in PK data analysis.|||h||Geometric Coefficient of Variation|Geometric Mean
2599445|NCT02174523|Primary|Lurasidone λz||pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose|All subjects with evaluable PK data were included in PK data analysis.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2599424|NCT02174627|Secondary|Proportion of Total Time of Interpolated Hb Values Greater Than or Equal To 10 g/dL From Week 28 to Week 52|Proportion of total time of interpolated Hb values ≥10 g/dL was calculated as the time the linearly interpolated curve between measurements ≥10 g/dL divided by the time between measurements from Week 28 to Week 52. Proportion of total time was analyzed using an ANCOVA model with baseline Hb and baseline eGFR as covariates, and CV history, geographic region and treatment group as fixed effects. The adjusted LS mean estimates of change from Week 28 to Week 52 are presented.|Week 28 up to Week 52.|The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. Participants without any Hb measurements from Week 28 were not included in the analysis.|||proportion of total time||Standard Error|Least Squares Mean
2599425|NCT02174627|Secondary|Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52 in Participants With Baseline High Sensitivity C-Reactive Protein (hsCRP) Greater Than the Upper Limit of Normal (ULN)|Baseline hsCRP was quantified from stored biomarker samples obtained at randomization. Baseline Hb was defined as the mean of the last 3 central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to mean value during Week 28 to Week 52 was analyzed using a MAR based multiple imputation ANCOVA model with baseline Hb, baseline eGFR, CV history, geographic region and treatment group as fixed effect covariates. The adjusted LS mean estimates of change from baseline in participants with baseline hsCRP >ULN to mean during Week 28 to Week 52 are presented.|Baseline (Day 1, Week 0) and Week 28 to Week 52.|The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis. Only participants who consented to the use of donated biomarker samples and had baseline hsCRP >ULN were included in the analysis.|||g/dL||Standard Error|Least Squares Mean
2599426|NCT02174627|Secondary|Percentage of Participants With Hb Response During the First 24 Weeks of Treatment|"Hb response was defined as:~Hb ≥ 11.0 g/dL and Hb increase from baseline by ≥ 1.0 g/dL for participants with baseline Hb > 8.0 g/dL; or~Hb increase from baseline by ≥ 2.0 g/dL, for participants with baseline Hb ≤ 8.0 g/dL at 2 consecutive visits (with available data) separated at least 5 days during the first 24 weeks of treatment without having received rescue therapy (red blood cell [RBC] transfusion, erythropoietin analogue, or intravenous [IV] iron) prior to Hb response. The percentage of participants with an Hb response during the first 24 weeks of treatment is presented."|Baseline (Day 1, Week 0) up to Week 24.|The Full Analysis Set (FAS) included all participants in the ITT analysis set who received at least 1 dose of IP and had baseline Hb and at least 1 post-dose Hb assessment. Participants from the FAS, with data available for analysis are presented.|||Percentage of participants|||Number
2599427|NCT02174627|Primary|Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52|Baseline Hb was defined as the mean of the last 3 central laboratory Hb values from the screening and randomization visits. Mean change in Hb from baseline to mean value from Week 28 to Week 52 was analyzed using a missing at random (MAR) based multiple imputation analysis of covariance (ANCOVA) model with baseline Hb, baseline estimated glomerular filtration rate (eGFR), cardiovascular (CV) history, geographic region and treatment group as fixed effect covariates. The adjusted least squares (LS) mean estimates of change from baseline to mean during Week 28 to Week 52 are presented.|Baseline (Day 1, Week 0) and Week 28 to Week 52.|The ITT analysis set included all participants who were randomized to IP irrespective of their protocol adherence and continued participation in the study, except for those excluded from analysis.|||g/dL||Standard Error|Least Squares Mean
2599428|NCT02174523|Primary|Lurasidone MRT||Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8|All subjects with evaluable PK data were included in PK data analysis.|||h||Geometric Coefficient of Variation|Geometric Mean
2599429|NCT02174523|Primary|Lurasidone t1/2||Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8|All subjects with evaluable PK data were included in PK data analysis.|||h||Geometric Coefficient of Variation|Geometric Mean
2599430|NCT02174523|Primary|Lurasidone λz||Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8|All subjects with evaluable PK data were included in PK data analysis.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2599431|NCT02174523|Primary|Lurasidone Tmax||Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8|All subjects with evaluable PK data were included in PK data analysis.|||h||Full Range|Median
2599432|NCT02174523|Primary|Lurasidone AUC0-∞||Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8|All subjects with evaluable PK data were included in PK data analysis.|||ng･h/mL||Geometric Coefficient of Variation|Geometric Mean
2599433|NCT02174523|Primary|Lurasidone AUC 0-τ||Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8|All subjects with evaluable PK data were included in PK data analysis.|||ng･h/mL||Geometric Coefficient of Variation|Geometric Mean
2599434|NCT02174523|Primary|Lurasidone AUC 0-24||Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8|All subjects with evaluable PK data were included in PK data analysis.|||ng･h/mL||Geometric Coefficient of Variation|Geometric Mean
2599435|NCT02174523|Primary|Lurasidone Cmax|Maximum (peak) observed drug serum concentration.|Day8||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2599436|NCT02174523|Primary|Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 6 and Day 7||Pre-dose (-0.5h) of Day6 and Day7||||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2599437|NCT02174523|Primary|Summary of Concentration (ng/mL) of Lurasidone - PK Population the Mean (SD) of Day 4 and Day 5||Pre-dose (-0.5h) of Day4 and Day5||||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2599438|NCT02174523|Primary|Accumulation Ratios Lurasidone,Ratio of Cmax,Ratio of AUC0-∞,Ratio of AUC0-τ,||Day 8/Day 1||||Ratios||90% Confidence Interval|Mean
2599439|NCT02174523|Primary|Lurasidone Vzss/F||Day 8|All subjects with evaluable PK data were included in PK data analysis.|||L||Geometric Coefficient of Variation|Geometric Mean
2599440|NCT02174523|Primary|Lurasidone Vz/F||pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose|All subjects with evaluable PK data were included in PK data analysis.|||L||Geometric Coefficient of Variation|Geometric Mean
2599441|NCT02174523|Primary|CLss/F||Day8 0.5hours pre-dose, 0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose in day 8|All subjects with evaluable PK data were included in PK data analysis.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2599454|NCT02174510|Primary|Lurasidone t1/2|t1/2 :Biological half life correlated with the elimination rate constant (kel) of semi-logarithmic concentration-time curve|pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose||||h||Geometric Coefficient of Variation|Geometric Mean
2599455|NCT02174510|Primary|Lurasidone λZ|λZ：Elimination rate constant|pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose||||1/h||Geometric Coefficient of Variation|Geometric Mean
2599456|NCT02174510|Primary|Lurasidone Tmax|Tmax：Time to maximum (peak) drug serum concentration|pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose||||h||Full Range|Median
2599457|NCT02174510|Primary|Lurasidone AUC|AUC：Area under the serum concentration-time curve|pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose||||ng･h/mL||Geometric Coefficient of Variation|Geometric Mean
2599458|NCT02174510|Primary|Lurasidone Cmax|Cmax：Maximum (peak) observed drug serum concentration.|pre-dose,0.5,1,1.5,2,3,4,6,8,12,24,36,48 hours post-dose|ALL 28 subjects who received lurasidone and have evaluable PK data.|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2599459|NCT02174276|Secondary|Number of Participants With Drug-Resistance Mutations at Week 48 or at the Last Visit Available|Resistance surveillance analysis was conducted at Week 48 or Early Discontinuation (with at least 24 weeks of exposure to TDF) for any participants who met inclusion criteria (HBV DNA ≥ 69 IU/mL). Drug-resistant mutation status was assessed using HBV polymerase/ reverse transcriptase (pol/RT) population sequencing.|Baseline to Week 48|Participants with at least 24 weeks of exposure to TDF and with HBV DNA ≥ 69 IU/mL at Week 48 or Early Discontinuation were analyzed.|||Participants|||Count of Participants
2599460|NCT02174276|Secondary|Percentage of Participants Experiencing Virologic Breakthrough at Week 48|Virologic breakthrough was defined as HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL, or a ≥ 1.0 log10 increase in HBV DNA from nadir. Two consecutive visits that met the definition were required for a participant to be classified as having had virologic breakthrough.|Baseline to Week 48|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2599461|NCT02174276|Secondary|Percentage of Participants Experiencing Virologic Breakthrough at Week 24|Virologic breakthrough was defined as HBV DNA ≥ 69 IU/mL after having been < 69 IU/mL, or having had ≥ 1.0 log10 increase in HBV DNA from nadir. Two consecutive visits that met the definition were required for a participant to be classified as having had virologic breakthrough.|Baseline to Week 24|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2599462|NCT02174276|Secondary|Percentage of Participants With HBV DNA < LLOQ at Week 48|The LLOQ was defined as 20 IU/mL.|Week 48|Participants in the Full Analysis Set with available data were analyzed. The missing equals excluded approach was used.|||percentage of participants|||Number
2599463|NCT02174276|Secondary|Percentage of Participants With HBV DNA < Lower Limit of Quantification (LLOQ) at Week 24|The LLOQ was defined as 20 IU/mL.|Week 24|Participants in the Full Analysis Set with available data were analyzed. The missing equals excluded approach was used.|||percentage of participants|||Number
2599464|NCT02174276|Secondary|Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 48|HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBeAg loss and seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBeAg loss within the targeted time window.|Baseline to Week 48|Participants in the Full Analysis Set with HBeAg positive at baseline were analyzed. The missing equals failure approach was used.|||percentage of participants|||Number
2599465|NCT02174276|Secondary|Composite Endpoint Measuring the Percentage of Participants With HBeAg Loss and HBeAg Seroconversion at Week 24|HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBeAg loss and seroconversion was defined as qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBeAg loss within the targeted time window.|Baseline to Week 24|Participants in the Full Analysis Set with HBeAg positive at baseline were analyzed. The missing equals failure approach was used.|||percentage of participants|||Number
2599466|NCT02174276|Secondary|Percentage of Participants With HBeAg Loss at Week 48|HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.|Baseline to Week 48|Participants in the Full Analysis Set with HBeAg positive at baseline were analyzed. The missing equals failure approach was used.|||percentage of participants|||Number
2599467|NCT02174276|Secondary|Percentage of Participants With HBeAg Loss at Week 24|HBeAg loss was defined as qualitative HBeAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.|Baseline to Week 24|Participants in the Full Analysis Set with HBeAg positive at baseline were analyzed. The missing equals failure approach was used.|||percentage of participants|||Number
2599468|NCT02174276|Secondary|Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 48|HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.|Baseline to Week 48|Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used.|||percentage of participants|||Number
2599469|NCT02174276|Secondary|Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 24|HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.|Baseline to Week 24|Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used.|||percentage of participants|||Number
2599470|NCT02174276|Secondary|Percentage of Participants With a ≥ 0.5 Log10 IU/mL or a ≥ 1.0 Log10 IU/mL Decline in HBsAg at Week 12|HBsAg with a ≥ 0.5 or ≥ 1.0 log10 IU/mL decline was defined as ≥ 0.5 or ≥ 1.0 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.|Baseline to Week 12|Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used.|||percentage of participants|||Number
2599935|NCT02169219|Secondary|Disease Response|Number of patients achieving disease response defined as, no new disease manifestations; no worsening of existing disease; stable or improved BVAS/WG score at 4 weeks.|4 weeks|Number of patients having a disease response|||Participants|||Count of Participants
2599471|NCT02174276|Secondary|Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48|HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBsAg loss and seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBsAg loss within the targeted time window.|Baseline to Week 48|Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used.|||percentage of participants|||Number
2599472|NCT02174276|Secondary|Composite Endpoint Measuring the Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24|HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window. HBsAg loss and seroconversion was defined as qualitative HBsAb result changing from negative at baseline to positive at any postbaseline visit and the participant must have achieved HBsAg loss within the targeted time window.|Baseline to Week 24|Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used.|||percentage of participants|||Number
2599473|NCT02174276|Secondary|Percentage of Participants With HBsAg Loss at Week 48|HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.|Baseline to Week 48|Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used.|||percentage of participants|||Number
2599474|NCT02174276|Secondary|Percentage of Participants With HBsAg Loss at Week 24|HBsAg loss was defined as qualitative HBsAg test changing from positive at baseline to negative at any postbaseline visit within the targeted time window.|Baseline to Week 24|Participants in the Full Analysis Set were analyzed. The missing equals failure approach was used.|||percentage of participants|||Number
2599475|NCT02174276|Secondary|Mean Change in HBsAg From Baseline to Week 48|The change from baseline to Week 48 in HBsAg was analyzed using a MMRM. The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% CIs.|Baseline to Week 48|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||95% Confidence Interval|Least Squares Mean
2599476|NCT02174276|Secondary|Mean Change in HBsAg From Baseline to Week 12|The change from baseline to Week 12 in HBsAg was analyzed using a MMRM. The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% CIs.|Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||95% Confidence Interval|Least Squares Mean
2599477|NCT02174276|Primary|Mean Change in Serum HBsAg From Baseline to Week 24|The change from baseline to Week 24 in HBsAg was analyzed using a mixed effect model for repeated measures (MMRM). The model included treatment groups, ALT levels (> ULN or ≤ ULN) at baseline, HBeAg status (positive or negative) at baseline, HBsAg level at baseline, visit and treatment-by-visit interaction as fixed effects and visit as a repeated measurement. Estimated least square means of treatment effects are presented with the 95% confidence intervals (CIs).|Baseline to Week 24|Participants in the Full Analysis Set (all participants who were randomized and received at least 1 dose of study drug) with available data were analyzed.|||log10 IU/mL||95% Confidence Interval|Least Squares Mean
2599478|NCT02174198|Secondary|Thickness of Keratinized Tissue at 8mm|Tissue thickness was measured at 8mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper.|12 months||||mm||Standard Deviation|Mean
2599479|NCT02174198|Secondary|Thickness of Keratinized Tissue at 4mm|Tissue thickness was measured at 4mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper.|12 months||||mm||Standard Deviation|Mean
2599480|NCT02174198|Secondary|Thickness of Keratinized Tissue at 3mm|Tissue thickness was measured at 3mm from the free gingival margin (FGM) using a 15-endodontic file and a rubber stopper.|12 months||||mm||Standard Deviation|Mean
2599481|NCT02174198|Secondary|Periodontal Probing Depth|The periodontal probing depth will be measured in mm.|12 months|Data for this outcome measure was not collected and analyzed since all the patients on the study were periodontally healthy and showed no signs of soft tissue inflammation.||||||
2599482|NCT02174198|Secondary|Change in Vertical Dimension of Buccal Soft Tissue (Mesial Papilla)|The mean change was calculated from a tooth-supported stent to the free gingival margin.|Baseline and 12 months||||mm||Standard Deviation|Mean
2599483|NCT02174198|Secondary|Change in Vertical Dimension of Buccal Soft Tissue (Mid-buccal)|The mean change was calculated from a tooth-supported stent to the free gingival margin.|Baseline and 12 months||||mm||Standard Deviation|Mean
2599484|NCT02174198|Secondary|Change in Vertical Dimension of Buccal Soft Tissue (Distal Papilla)|The mean change was calculated from a tooth-supported stent to the free gingival margin.|Baseline and 12 months||||mm||Standard Deviation|Mean
2599485|NCT02174198|Primary|Mean Bucco-Lingual Change at 4mm|The horizontal dimensional change from a digital superimposition at 4mm apical to the baseline free gingival margin position was measured.|Baseline and 12 months||||mm||Standard Deviation|Mean
2599486|NCT02174198|Primary|Mean Bucco-Lingual Change at 3mm|The horizontal dimensional change from a digital superimposition at 3mm apical to the baseline free gingival margin position was measured.|Baseline and 12 months||||mm||Standard Deviation|Mean
2599487|NCT02173769|Secondary|Patient Satisfaction: Satisfaction With Handling of Inhaler|"Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.~Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7)."|4-6 weeks|FAS including patients with available handling of inhaler satisfaction data|||Percentage of participants|||Number
2599488|NCT02173769|Secondary|Patient Satisfaction: Satisfaction With Inhaler|"Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.~Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7)."|4-6 weeks|FAS including patients with available inhaler satisfaction data|||Percentage of participants|||Number
2599489|NCT02173769|Secondary|Patient Satisfaction: Overall Satisfaction|"Patient satisfaction with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 Microgram plus Striverdi Respimat.~Patient´s satisfaction with study treatment and handling of the Respimat inhaler was assessed on a 7-point-ordinal scale extending from very satisfied (1) to very unsatisfied (7)."|4-6 weeks|FAS including patients with available satisfaction data|||Percentage of participants|||Number
2599490|NCT02173769|Secondary|General Health of the Patient After 4-6 Weeks|"General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score after 4-6 weeks.~The PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent)."|4-6 weeks|FAS including patients with available PGE score at end of study visit|||Percentage of participants|||Number
2599491|NCT02173769|Secondary|General Health of the Patient at Baseline|"General health of the patient as evaluated by the physician using the Physician´s Global Evaluation (PGE) score at the initial examination.~The PGE score consists of an 8-point-scale which extends from 1 (very bad) to 8 (excellent)."|Baseline|FAS including patients with available PGE score at baseline|||Percentage of participants|||Number
2599492|NCT02173769|Secondary|Absolute Changes in the PF-10 Score|"Absolute changes in the PF-10 score.~The PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning."|4-6 weeks|FAS|||Units on a scale||Standard Deviation|Mean
2599493|NCT02173769|Primary|"Percentage of Participants With Therapeutic Success"|"Percentage of participants with therapeutic success defined as a 10-point increase in the physical activity assessed by patient´s questionnaire (PF-10) score between the initial examination and after 4-6 weeks.~The PF-10 score is a subscale of the quality of life questionnaire Short Form 36 (SF-36) and contains 10 questions concerning physical activity and capacity. The total score ranges from 0 to 100. A higher score indicates a better physical functioning."|Baseline and 4-6 weeks|Full analysis (FAS) which includes all patients enrolled in the study who did not violated any inclusion or exclusion criteria.|||Percentage of participants|||Number
2599494|NCT02173704|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization.|"Number of subjects reporting SAEs, medically attended AEs and AEs leading to premature withdrawal from the study and leading to death and AEs leading to hospitalization following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix®) compared to when only routine vaccines were administered alone.~SAEs assessed included medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.~Possibly or probably related SAE were SAEs assessed by the investigator as related to the vaccination.~Medically attended AEs were events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason."|Throughout the study period (Day 1 to Day 335)|Analysis was done on Safety set population (unsolicited AEs). The safety set population (unsolicited AEs) included all subjects in the Exposed Population who had postvaccination unsolicited AE records.|||Number of participants|||Number
2599495|NCT02173704|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines|Number of subjects reporting any unsolicited AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B® or Priorix® and Varilrix®) compared to when only routine vaccines were administered alone.|From day 1 to day 7 after each vaccination|Analysis was done on Safety set population (unsolicited AEs). The safety set population (unsolicited AEs) included all subjects in the Exposed Population who had postvaccination unsolicited AE records.|||Number of subjects|||Number
2599496|NCT02173704|Secondary|Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age.|"Number of subjects who reported solicited systemic AEs reported after the administration of Varilrix® and Priorix® vaccines (with and without Bexsero® vaccine) at 12 months of age.~Solicited systemic AEs assessed were Rash, Lymphadenopathy and Fever. This analysis was conducted for a prolonged period of 28 Days following Varilrix® and Priorix® administration."|From Day 1 to Day 28 after vaccination|Analysis was done on Safety set population (solicited AEs).The safety set population (solicited AEs) included all subjects in the Exposed Population who provided postvaccination reactogenicity data.|||Number of participants|||Number
2599497|NCT02173704|Secondary|Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.|"Number of subjects reporting solicited systemic AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B® at 2, 4 and 6 months of age and Priorix® and Varilrix® at 12 months of age) compared to when only routine vaccines were alone, at 2, 4, 6 and 12 months.~Systemic solicited symptoms assessed were Change in Eating Habits, Diarrhea, Irritability, Persistent Crying, Rash, Sleepiness, Vomiting and Fever (body temperature ≥ 38.0 °C)"|From day 1 (6 hours) to day 7 after each vaccination|Analysis was done on Safety set population (solicited AEs).The safety set population (solicited AEs) included all subjects in the Exposed Population who provided postvaccination reactogenicity data.|||Number of participants|||Number
2599498|NCT02173704|Secondary|Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age.|"Number of subjects reporting solicited local AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B® at 2, 4 and 6 months of age and Priorix® and Varilrix® at 12 months of age)compared to when only routine vaccines were administered alone at 2,4,6 and 12 months.~Solicited local symptoms assessed were Erythema, Induration, Swelling and Tenderness."|From day 1 (6 hours) to day 7 after each vaccination (1st, 2nd, 3rd and 4th vaccination)|Analysis was done on Safety set population (solicited AEs).The safety set population (solicited AEs) included all subjects in the Exposed Population who provided postvaccination reactogenicity data.|||Number of participants|||Number
2599611|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|3 years||2022-04-30|04/2022||||
2599499|NCT02173704|Secondary|Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines|Percentages of subjects with hSBA titers ≥1:8 against N.meningitidis serogroup B strains, at one month after concomitant administration of third primary dose of Bexsero® with routine vaccines [Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®] and at one month after concomitant administration of Bexsero® booster dose with routine vaccines [Priorix® and Varilrix® vaccine],as compared to when only routine vaccines were administered.|At Day 1,Day 152,Day 305, Day 335|Analysis was done on FAS population, which included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.|||Percentages of subjects||95% Confidence Interval|Number
2599500|NCT02173704|Secondary|hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains.|GMRs of post-vaccination versus pre-vaccination of hSBA titer against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 were evaluated at one month after the third vaccination with Bexsero® vaccine and concomitant routine vaccines (Infanrix-IPV+Hib®, Prevenar-13® and Engerix®) (Day 152) compared to baseline (Day 1) or at one month after the booster dose of Bexsero® vaccine with routine vaccines (Priorix®, Varilrix®) (Day 335) compared to prior to the booster dose (Day 305).|At Day 1, Day 152, Day 305 and Day 335|Analysis was performed on the FAS population, which included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.|||Ratio||95% Confidence Interval|Geometric Mean
2599501|NCT02173704|Secondary|hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines|hSBA GMTs against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 was evaluated at baseline (2 months of age, Day 1), 1 month after the third vaccination with Bexsero® with concomitant routine vaccines (Infanrix-IPV+Hib®, Prevenar-13®, Engerix®) (7 months of age, Day 152) or prior to the booster dose of Bexsero® with routine vaccines (Priorix®, Varilrix®) (12 months of age, Day 305) and 1 month after the booster dose (13 months of age, Day 335), as compared to when only routine vaccines were administered.|At Day 1, Day 152, Day 305 and Day 335|Analysis was performed on the FAS population, which included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.|||Titer||95% Confidence Interval|Geometric Mean
2599502|NCT02173704|Secondary|Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines)|Percentage of subjects with hSBA titer ≥ 1:5 before booster vaccination and after booster vaccination when Bexsero® booster dose was given with routine vaccines (Priorix® + Varilrix® vaccine) as compared to when only routine vaccines were administered.|At Day 305 and Day 335|Analysis was done on FAS population Day 335. The FAS population included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.|||Percentage of subjects||95% Confidence Interval|Number
2599503|NCT02173704|Primary|Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B.|Percentage of subjects with hSBA titer ≥ 1:5 at 1 month following the third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®).|At Day 1 and at one month after the third vaccination (Day 152)|Analysis was done on Full Analysis Set (FAS) population day 152. The FAS population included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points.|||Percentages of subjects||95% Confidence Interval|Number
2599504|NCT02173548|Secondary|Hospital Admission for Acute Decompensated Heart Failure|Number of participants admitted to hospital for acute decompensated heart failure|24 weeks||||Participants|||Count of Participants
2599505|NCT02173548|Secondary|Change in Quality of Life Questionnaire-Duke Activity Status Index (DASI)|Two independent questionnaires will be used to assess quality of life and HF symptoms. The Duke Activity Status Index (DASI) questionnaire is a 12-question, yes/no, instrument that allows for the calculation of perceived functional capacity, in which each question describes a different physical activity and the questions are weighted according to their degree of physical exertion. Higher scores indicate greater functional capacity. The questionnaire will be administered at 0, 4, 12 and 24 weeks in accordance with cardiopulmonary test (CPET) and echocardiography. Scores range from zero to 58.2 with higher scores indicating higher functional status.|Baseline to 12 weeks||||units on DASI scale||Inter-Quartile Range|Median
2599506|NCT02173548|Secondary|Change in Quality of Life Questionnaire-Minnesota Living With Heart Failure Questionnaire (MLWHF)|The Minnesota Living with Heart Failure questionnaire (MLWHF) is a 21-question graded questionnaire that has been extensively used to measure impairment in quality of life in patients with HF, with higher scores reflecting increased burden of HF symptoms. The questionnaire will be administered in accordance with cardiopulmonary test (CPET) and echocardiography. Scores range from zero to 105 with lower scores indicating better quality of life.|Baseline to 24 weeks||||units on MWLHF scale||Inter-Quartile Range|Median
2599507|NCT02173548|Secondary|Change in Inflammation (C Reactive Protein Levels)|The change C reactive protein (CRP) levels will be reported at 12 weeks. Higher C reactive protein levels indicate greater inflammation.|Baseline to 12 weeks||||mg/l||Inter-Quartile Range|Median
2599508|NCT02173548|Secondary|Change in Diastolic and Contractile Reserve (e' Velocity and E/e' Ratio)|Exercise stress echocardiography will be performed at baseline and 12 weeks to measure diastolic and contractile reserve. We will perform an assessment before initiation of exercise and immediately after cessation of peak exercise.|Baseline to 12 weeks|Data not available for all participants.|||ratio||Inter-Quartile Range|Median
2599509|NCT02173548|Secondary|Echocardiographic Assessment of Diastolic and Systolic Function (Left Ventricular Ejection Fraction)|Structural and functional echocardiographic parameters include left and right ventricular dimensions, mass, systolic and diastolic function. (Change in e')|12 weeks||||cm/second||Inter-Quartile Range|Median
2599510|NCT02173548|Primary|Change in Ventilatory Eefficiency|Absolute changes in ventilatory efficiency (VE/VCO2 [carbon dioxide] slope) after 12 weeks treatment. This will compare patients treated with anakinra vs placebo, and provide a randomized, double-blinded assessment of the effects of IL-1β blockade on aerobic exercise performance.|Baseline to 12 weeks||||VE/VO2 slope||Inter-Quartile Range|Median
2599511|NCT02173548|Primary|Change in Aerobic Exercise Capacity|Absolute changes in aerobic exercise capacity (peak VO2) after 12 weeks treatment. This will compare patients treated with anakinra and provide a randomized, double-blinded assessment of the effects of IL-1β blockade on aerobic exercise performance.|Baseline to 12 weeks||||ml/kg/min||Inter-Quartile Range|Median
2599512|NCT02173535|Primary|Number of Subject in Agreement (Enhance Eyes)|"Subjects' responses to the question Enhance my overall appearance were categorized into a binary variable. If a subject responded Agrees Somewhat or Agrees Strongly then response=1. If a subject responds Neither Agrees nor Disagrees, Disagrees Somewhat Disagrees Strongly then response=0. The number of subjects with response=1 was reported for each lens."|15-20 Minutes Post Lens Insertion|Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints|||Participants|||Number
2599513|NCT02173535|Primary|Number of Subject in Agreement (Defines Eyes)|"Subjects' responses to the question Define my eye were categorized into a binary variable. If a subject responded Agrees Somewhat or Agrees Strongly then response=1. If a subject responds Neither Agrees nor Disagrees, Disagrees Somewhat Disagrees Strongly then response=0. The number of subjects with response=1 was reported for each lens."|15-20 Minutes Post Lens Insertion|Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints|||Participants|||Number
2599514|NCT02173535|Primary|Number of Subject in Agreement (Bigger Eyes)|"Subjects' responses to the question Make my eye look bigger were categorized into a binary variable. If a subject responded Agrees Somewhat or Agrees Strongly then response=1. If a subject responds Neither Agrees nor Disagrees, Disagrees Somewhat Disagrees Strongly then response=0. The number of subjects with response=1 was reported for each lens."|15-20 Minutes Post Lens Insertion|Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints|||Participants|||Number
2599515|NCT02173522|Secondary|Histologic Changes in the Prostate After PAE|The Gleason Score prostate Cancer Grading and Prognostic scoring system will be used to determine the histologic changes in the prostate tumor. Since prostate tumors are often made up of cancerous cells that have different grades, two grades are assigned to each patient. A primary grade is given to describe the cells that make up the largest area of the tumor and a secondary grade is given to describe the cells of the next largest area. The sums of the scores will be evaluated. The Gleason Score sum will range from 1 - 10, with the higher score indicating a more advanced neoplasm.|Between baseline prostate biopsy and RALRP||||Units on a scale||Standard Deviation|Mean
2599516|NCT02173522|Secondary|Change in PSA Following PAE|Patients who undergo PAE will have blood tests to determine the change in their PSA levels between baseline and 6 weeks post PAE.|6 weeks post PAE||||ng/mL||Standard Deviation|Mean
2599517|NCT02173522|Secondary|Change From Baseline in Erectile Function at One Year Post RALRP|The International Index of Erectile Function (IIEF) questionnaire is a multi-dimensional self-administered test found to be used in the clinical assessment of erectile dysfunction. It examines the 4 main domains of male sexual function. A higher score would indicated less dysfunction. The scores can range 6 to 75|Baseline,1 year post RALRP||||Score on a scale||Standard Deviation|Mean
2599518|NCT02173522|Secondary|PAE-related Adverse Events|Any adverse event occurring between the date of PAE and 1 year of follow-up that the investigators determine to be related to the PAE procedure will be assessed.|Through 1 year post RALRP||||adverse events|||Number
2599519|NCT02173522|Secondary|RALRP-related Adverse Events|Any adverse event occurring between the date of RALRP and 1 year of follow-up that the investigators determine to be related to the RALRP procedure will be assessed.|Through 1 year post RALRP||||adverse events|||Number
2599520|NCT02173522|Secondary|Return to Continence|Return to continence following the RALRP procedure will be determined by the pad weight test, conducted at each follow-up visit until the patient is continent.|An expected average of 1 week post RALRP||||grams||Standard Deviation|Mean
2599521|NCT02173522|Secondary|Biochemical Recurrence of Prostate Cancer|Biochemical recurrence of prostate cancer will be determined by PSA levels 1 year following the RALRP procedure.|1 year post RALRP||||ng/mL||Standard Deviation|Mean
2599522|NCT02173522|Secondary|Number of Participants for Whom Prostatectomy Procedure Did Not Succeed in Removing the Entire Cancer|Histopathology examination post RALRP will be used to determine if the prostatectomy procedure succeeded in removing the entire cancer.|RALRP procedure||||Participants|||Count of Participants
2599523|NCT02173522|Secondary|Length of Hospital Stay After RALRP||48 hours post procedure||||Days||Standard Deviation|Median
2599524|NCT02173522|Secondary|RALRP Duration||RALRP procedure||||hr||Standard Deviation|Mean
2599525|NCT02173522|Secondary|Number of Patients That Required Blood Transfusion|Requirement for blood transfusion during the prostatectomy procedure will be assessed in all patients. The surgeon performing the prostatectomy will determine whether or not patients require blood transfusions.|RALRP procedure||||participants|||Number
2599526|NCT02173522|Secondary|Change in Prostate Volume|Patients who receive PAE will undergo MRIs before PAE and 6 weeks after PAE to assess any change in prostate volume following the embolization procedure.|Baseline, 6 weeks post PAE||||cc||Standard Deviation|Mean
2599527|NCT02173522|Secondary|Change in Hematocrit|Patients will undergo a blood test to assess their hematocrit prior to surgery on the day of RALRP, and again on post operative day 1 to determine the change in the hematocrit following surgery.|Baseline, RALRP post operative day 1||||percentage of red blood cells||Standard Deviation|Mean
2599528|NCT02173522|Secondary|Change in Hemoglobin Compared to Baseline|Patients will undergo a blood test to assess their hemoglobin level prior to surgery on the day of RALRP, and again on post operative day 1 to determine the change in the hemoglobin level following surgery.|Baseline, RALRP post operative day||||G/DL||Standard Deviation|Mean
2599529|NCT02173522|Primary|Estimated Blood Loss During Robot-assisted Laparoscopic Radical Prostatectomy (RALRP)|Blood loss during the robotic prostatectomy will be estimated by the surgeon performing the procedure.|RALRP procedure, up to 3 hours||||mL||Standard Deviation|Mean
2599530|NCT02173392|Secondary|Immunogenicity|Presence of binding or neutralizing anti-brodalumab antibodies|60 days||||participants|||Number
2599612|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|2 years||2022-04-30|04/2022||||
2599531|NCT02173392|Primary|Area Under the Drug Concentration Time Curve From Zero to the Time of Last Quantifiable Concentration of Brodalumab|Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection|60 days|Participants analyzed is a combination of period 1 and period 2 participants results, thus the higher number of overall participants analyzed|||(day*mg/mL)||Standard Deviation|Mean
2599532|NCT02173392|Primary|Pharmacokinetic Parameters for the Maximum Amount of Observed Brodalumab Concentration for Treatment A and Treatment B.|Pharmacokinetic parameter estimates after a 210 mg dose of brodalumab, and after two 210 mg doses of brodalumab delivered subcutaneously as a single prefilled syringe (PFS) injection|60 days|Number of participants analyzed reflects the combination of participants analyzed at period one and then again at period two|||milligrams per milliliter||Standard Deviation|Mean
2599533|NCT02173379|Other Pre-specified|Landmark Analysis on TLF and Components|TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).|3-5 years||2022-04-30|04/2022||||
2599534|NCT02173379|Other Pre-specified|Landmark Analysis on TLF and Components|TLF is defined as composite of Cardiac Death, Myocardial Infarction (MI) attributable to Target Vessel (TV-MI), or Ischemia- Driven Target Lesion Revascularization (ID-TLR).|3-4 years||2022-04-30|04/2022||||
2599535|NCT02173379|Other Pre-specified|Patient Reported Outcomes (PRO)|"Patient-reported outcomes (PRO) are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.~The following questionnaires will be used in this study:~Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life~EuroQoL 5D (EQ-5D) survey to assess overall health status~(Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)~The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.~Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial."|5 years||2022-04-30|04/2022||||
2599536|NCT02173379|Other Pre-specified|Patient Reported Outcomes|"Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.~The following questionnaires will be used in this study:~Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life~EuroQoL 5D (EQ-5D) survey to assess overall health status~(Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)~The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.~Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial."|3 years||2022-04-30|04/2022||||
2599537|NCT02173379|Other Pre-specified|Patient Reported Outcomes|"Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.~The following questionnaires will be used in this study:~Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life~EuroQoL 5D (EQ-5D) survey to assess overall health status~(Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)~The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.~Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial."|1 year||2022-04-30|04/2022||||
2599538|NCT02173379|Other Pre-specified|Patient Reported Outcomes|"Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.~The following questionnaires will be used in this study:~Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life~EuroQoL 5D (EQ-5D) survey to assess overall health status~(Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)~The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.~Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial."|6 months||2022-04-30|04/2022||||
2599539|NCT02173379|Other Pre-specified|Patient Reported Outcomes|"Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.~The following questionnaires will be used in this study:~Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life~EuroQoL 5D (EQ-5D) survey to assess overall health status~(Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)~The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.~Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial."|1 month||2022-04-30|04/2022||||
2599540|NCT02173379|Other Pre-specified|Patient Reported Outcomes|"Patient-reported outcomes are informational endpoints to assess Health-Related Quality of Life. PRO assessments will be conducted at baseline, 1 and 6 months, and at 1, 3 and 5 years.~The following questionnaires will be used in this study:~Seattle Angina Questionnaire-7 (SAQ-7) to assess disease-specific Quality of Life~EuroQoL 5D (EQ-5D) survey to assess overall health status~(Note: PRO endpoints will be evaluated in the ~2610 subjects of ABSORB IV)~The PROs will be analyzed to evaluate the relationship between quality of life and cardiovascular events that occurred post-PCI and to substantiate the clinical impact of the angina events identified in the trial.~Assessments are made at all time points listed. But overall analysis of QoL is planned to be conducted at the end of the trial."|Baseline||2022-04-30|04/2022||||
2599588|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599613|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|1 year||2022-04-30|04/2022||||
2599541|NCT02173379|Secondary|Number of Participants With Cumulative Stent/Scaffold Thrombosis|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|0 to 30 Days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599542|NCT02173379|Secondary|Number of Participants With Target Lesion Failure (TLF)|The analysis will be based on 4610 subjects (2000 primary analysis subjects of ABSORB III and 2610 subjects of ABSORB IV)|1 year||2022-04-30|04/2022||||
2599543|NCT02173379|Secondary|Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)||3-5 years||2022-04-30|04/2022||||
2599544|NCT02173379|Secondary|Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)||3-4 years||2022-04-30|04/2022||||
2599545|NCT02173379|Secondary|Landmark Analysis on MACE and TVF and Their Components||3-5 years||2022-04-30|04/2022||||
2599546|NCT02173379|Secondary|Landmark Analysis on MACE and TVF and Their Components||3-4 years||2022-04-30|04/2022||||
2599547|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||5 years||2022-04-30|04/2022||||
2599548|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||4 years||2022-04-30|04/2022||||
2599549|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||3 years||2022-04-30|04/2022||||
2599550|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||2 years||2022-04-30|04/2022||||
2599551|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||1 year||2022-04-30|04/2022||||
2599552|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||270 days||2022-04-30|04/2022||||
2599553|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||180 days||2022-04-30|04/2022||||
2599554|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||90 days||2022-04-30|04/2022||||
2599555|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599556|NCT02173379|Secondary|Number of Participants With Repeat Coronary Arteriography||In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599557|NCT02173379|Secondary|Number of Participants With Rehospitalization|"CAD related~Cardiovascular, non-CAD related~Non-cardiovascular related"|5 years||2022-04-30|04/2022||||
2599558|NCT02173379|Secondary|Number of Participants With Rehospitalization|"CAD related~Cardiovascular, non-CAD related~Non-cardiovascular related"|4 years||2022-04-30|04/2022||||
2599559|NCT02173379|Secondary|Number of Participants With Rehospitalization|"CAD related~Cardiovascular, non-CAD related~Non-cardiovascular related"|3 years||2022-04-30|04/2022||||
2599560|NCT02173379|Secondary|Number of Participants With Rehospitalization|"CAD related~Cardiovascular, non-CAD related~Non-cardiovascular related"|2 years||2022-04-30|04/2022||||
2599561|NCT02173379|Secondary|Number of Participants With Rehospitalization|"CAD related~Cardiovascular, non-CAD related~Non-cardiovascular related"|1 year||2022-04-30|04/2022||||
2599562|NCT02173379|Secondary|Number of Participants With Rehospitalization|"CAD related~Cardiovascular, non-CAD related~Non-cardiovascular related"|270 days||2022-04-30|04/2022||||
2599563|NCT02173379|Secondary|Number of Participants With Rehospitalization|"CAD related~Cardiovascular, non-CAD related~Non-cardiovascular related"|180 days||2022-04-30|04/2022||||
2599564|NCT02173379|Secondary|Number of Participants With Rehospitalization|"CAD related~Cardiovascular, non-CAD related~Non-cardiovascular related"|90 days||2022-04-30|04/2022||||
2599565|NCT02173379|Secondary|Number of Participants With Rehospitalization|"Coronary artery disease (CAD) related~Cardiovascular, non-CAD related~Non-cardiovascular related"|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599566|NCT02173379|Secondary|Number of Participants With Scaffold/Stent Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained|Very late (>1 year post stent implantation)||2022-04-30|04/2022||||
2599567|NCT02173379|Secondary|Number of Participants With Scaffold/Stent Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|Late (30 days - 1 year post stent implantation)||2022-04-30|04/2022||||
2599568|NCT02173379|Secondary|Number of Participants With Scaffold/Stent Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|Subacute (>24 hours - 30 days post stent implantation)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599569|NCT02173379|Secondary|Number of Participants With Scaffold/Stent Thrombosis (Per Academic Research Consortium (ARC) Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|Acute (0 - 24 hours post stent implantation)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599570|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|5 years||2022-04-30|04/2022||||
2599571|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|4 years||2022-04-30|04/2022||||
2599572|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|3 years||2022-04-30|04/2022||||
2599573|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|2 years||2022-04-30|04/2022||||
2599574|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|1 year||2022-04-30|04/2022||||
2599575|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|270 days||2022-04-30|04/2022||||
2599576|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|180 days||2022-04-30|04/2022||||
2599577|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|90 days||2022-04-30|04/2022||||
2599578|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599579|NCT02173379|Secondary|Number of Participants Experienced Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599580|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|5 years||2022-04-30|04/2022||||
2599581|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|4 years||2022-04-30|04/2022||||
2599582|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|3 years||2022-04-30|04/2022||||
2599583|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|2 years||2022-04-30|04/2022||||
2599584|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|1 year||2022-04-30|04/2022||||
2599585|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|270 days||2022-04-30|04/2022||||
2599586|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|180 days||2022-04-30|04/2022||||
2599587|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|90 days||2022-04-30|04/2022||||
2599589|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR/ID-TVR, Non TL (Target Vessel Failure, TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599590|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|5 years||2022-04-30|04/2022||||
2599591|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|4 years||2022-04-30|04/2022||||
2599592|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|3 years||2022-04-30|04/2022||||
2599593|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|2 years||2022-04-30|04/2022||||
2599594|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|1 year||2022-04-30|04/2022||||
2599595|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|270 days||2022-04-30|04/2022||||
2599596|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|180 days||2022-04-30|04/2022||||
2599597|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|90 days||2022-04-30|04/2022||||
2599598|NCT02173379|Secondary|Number of Participants Experienced With Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599599|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599600|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|5 years||2022-04-30|04/2022||||
2599601|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|4 years||2022-04-30|04/2022||||
2599602|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|3 years||2022-04-30|04/2022||||
2599603|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|2 years||2022-04-30|04/2022||||
2599604|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|1 year||2022-04-30|04/2022||||
2599605|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|270 days||2022-04-30|04/2022||||
2599606|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|180 days||2022-04-30|04/2022||||
2599607|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|90 days||2022-04-30|04/2022||||
2599608|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599609|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|5 years||2022-04-30|04/2022||||
2599610|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|4 years||2022-04-30|04/2022||||
2612782|NCT02029521|Secondary|Vitamin E|Serum Vitamin E levels were measured to determine if treatment affected this test.|6 months|All participants.|||milligrams per liter||Standard Deviation|Mean
2599614|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|270 days||2022-04-30|04/2022||||
2599615|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|180 days||2022-04-30|04/2022||||
2599616|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|90 days||2022-04-30|04/2022||||
2599617|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599618|NCT02173379|Secondary|Number of Participants Experienced Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599619|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|5 years||2022-04-30|04/2022||||
2599620|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|4 years||2022-04-30|04/2022||||
2599621|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|3 years||2022-04-30|04/2022||||
2599622|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|2 years||2022-04-30|04/2022||||
2599623|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|1 year||2022-04-30|04/2022||||
2599624|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|270 days||2022-04-30|04/2022||||
2599642|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|2 years||2022-04-30|04/2022||||
2599625|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|180 days||2022-04-30|04/2022||||
2599626|NCT02173379|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|90 days||2022-04-30|04/2022||||
2599627|NCT02173379|Secondary|Number of Participants Experienced All Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599628|NCT02173379|Secondary|Number of Participants Experienced All Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599629|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|5 years||2022-04-30|04/2022||||
2599630|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|4 years||2022-04-30|04/2022||||
2599631|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|3 years||2022-04-30|04/2022||||
2599632|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|2 years||2022-04-30|04/2022||||
2599633|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|1 year||2022-04-30|04/2022||||
2599634|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|270 days||2022-04-30|04/2022||||
2599635|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|180 days||2022-04-30|04/2022||||
2599636|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|90 days||2022-04-30|04/2022||||
2599637|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599638|NCT02173379|Secondary|Number of Participants With All Coronary Revascularization|Revascularization includes TLR, TVR excluding TLR, and non TVR.|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599639|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|5 years||2022-04-30|04/2022||||
2599640|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|4 years||2022-04-30|04/2022||||
2599641|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|3 years||2022-04-30|04/2022||||
2618867|NCT01968382|Secondary|Change in Serum Bile Acids|Serum bile acids levels as measured using standard blood serum assay|Baseline to 90 days|Data not collected||||||
2599643|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|1 year||2022-04-30|04/2022||||
2599644|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|270 days||2022-04-30|04/2022||||
2599645|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. classified as: Ischemic driven TVR and Non-ischemic driven TVR.~-TVR includes all TVR, excluding TLR"|180 days||2022-04-30|04/2022||||
2599646|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|90 days||2022-04-30|04/2022||||
2599647|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599648|NCT02173379|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~TVR includes both Ischemic driven TVR and Non-ischemic driven TVR.~TVR includes all TVR, excluding TLR"|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599649|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|5 years||2022-04-30|04/2022||||
2599650|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|4 years||2022-04-30|04/2022||||
2599651|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|3 years||2022-04-30|04/2022||||
2599652|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|2 years||2022-04-30|04/2022||||
2599653|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|1 year||2022-04-30|04/2022||||
2599654|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|270 days||2022-04-30|04/2022||||
2599655|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|180 days||2022-04-30|04/2022||||
2599656|NCT02173379|Secondary|Number of Participants withTarget Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|90 days||2022-04-30|04/2022||||
2599657|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599658|NCT02173379|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven or not ischemia driven by the investigator prior to repeat angiography.|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599659|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|5 years||2022-04-30|04/2022||||
2599660|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|4 years||2022-04-30|04/2022||||
2599661|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|3 years||2022-04-30|04/2022||||
2599662|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|2 years||2022-04-30|04/2022||||
2599663|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|1 year||2022-04-30|04/2022||||
2599664|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|270 days||2022-04-30|04/2022||||
2599665|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|180 days||2022-04-30|04/2022||||
2599666|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|90 days||2022-04-30|04/2022||||
2599667|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599668|NCT02173379|Secondary|Number of Participants With Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599669|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|5 years||2022-04-30|04/2022||||
2599670|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|4 years||2022-04-30|04/2022||||
2599671|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|3 years||2022-04-30|04/2022||||
2599672|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|2 years||2022-04-30|04/2022||||
2599673|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|1 year||2022-04-30|04/2022||||
2599674|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|270 days||2022-04-30|04/2022||||
2599675|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|180 days||2022-04-30|04/2022||||
2599676|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|90 days||2022-04-30|04/2022||||
2600076|NCT02167451|Primary|Area Under The Concentration-Time Curve (AUC) of Maraviroc|pK target >100ng/ml at day 10 at the following time points : before the dose and 1, 2, 4, 6, 8, and 12 hours after maraviroc administration|Day 10||||hour*ng/mL||Standard Deviation|Mean
2599677|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599678|NCT02173379|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|In-hospital (≤ 7 days post index procedure)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599679|NCT02173379|Secondary|Number of Participants With Acute Success- Procedural Success (Subject Level Analysis)|Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).|In-hospital (≤ 7days)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599680|NCT02173379|Secondary|Percentage of Target Lesion With Acute Success- Device Success (Lesion Level Analysis)|Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.|In-hospital (≤ 7days)|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of target lesions|Target lesions||Number
2599681|NCT02173379|Secondary|Number of Participants With Powered Angina|"Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC).~This analysis will exclude angina or angina equivalent symptoms that occurred following the index procedure through hospital discharge or 7 days, whichever occurs first."|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599682|NCT02173379|Secondary|Powered TLF, Tested for Non-inferiority of Absorb BVS to XIENCE|This analysis will consist of ~2610 subjects in ABSORB IV.|1 year||2022-04-30|04/2022||||
2599683|NCT02173379|Primary|Number of Participants With Target Lesion Failure (TLF)|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|30 days|ITT population.The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2599684|NCT02173158|Secondary|Change in LDL-C|Mean percent change from baseline|Baseline to Week 56|Full analysis set for the safety phase included all subjects who received study drug during the safety phase and had at least one assessment during the safety phase|||Percent change||Standard Deviation|Mean
2599685|NCT02173158|Secondary|Change in Apo AI|Mean percent change from baseline|Baseline to Week 56|Full analysis set for the safety phase included all subjects who received study drug during the safety phase and had at least one assessment during the safety phase|||Percent change||Standard Deviation|Mean
2599686|NCT02173158|Secondary|Change in HDL-C|Mean percent change from baseline|Baseline to Week 56|Full analysis set for the safety phase included all subjects who received study drug during the safety phase and had at least one assessment during the safety phase|||Percent change||Standard Deviation|Mean
2599687|NCT02173158|Secondary|Change in Lp(a)|Mean percent change from baseline|Baseline to Week 56|Full analysis set for the safety phase included all subjects who received study drug during the safety phase and had at least one assessment during the safety phase|||Percent change||Standard Deviation|Mean
2599688|NCT02173158|Secondary|Change in VLDL-C|Mean percent change from baseline|Baseline to Week 56|Full analysis set for the safety phase included all subjects who received study drug during the safety phase and had at least one assessment during the safety phase|||Percent change||Standard Deviation|Mean
2599689|NCT02173158|Secondary|Change in Non-HDL-C|Mean percent change from baseline|Baseline to Week 56|Full analysis set for the safety phase included all subjects who received study drug during the safety phase and had at least one assessment during the safety phase|||Percent change||Standard Deviation|Mean
2599690|NCT02173158|Secondary|Change in Triglycerides|Mean percent change from baseline|Baseline to Week 56|Full analysis set for the safety phase included all subjects who received study drug during the safety phase and had at least one assessment during the safety phase|||Percent change||Standard Deviation|Mean
2599691|NCT02173158|Secondary|Change in Apo B|Mean percent change from baseline|Baseline to Week 56|Full analysis set for the safety phase included all subjects who received study drug during the safety phase and had at least one assessment during the safety phase|||Percent change||Standard Deviation|Mean
2599692|NCT02173158|Secondary|Change in Total Cholesterol|Mean percent change from baseline|Baseline to Week 56|Full analysis set for the safety phase included all subjects who received study drug during the safety phase and had at least one assessment during the safety phase|||Percent change||Standard Deviation|Mean
2599693|NCT02173158|Primary|Percent Change in LDL-C|Mean percent change from baseline|Baseline to Week 26|Full analysis set for the efficacy phase, included all subjects who received study drug and had a baseline and at least one post-baseline assessment|||Percent change||Standard Deviation|Mean
2600077|NCT02167451|Primary|Incidence of Visceral GVHD|determine the number of patients who develop visceral GVHD by day+100|day+100|all patients enrolled on trial|||Participants|||Count of Participants
2599694|NCT02173054|Secondary|Reduction of Severity of Acne: Acne Severity Index (ASI)|"The ASI score was calculated from the number of papules + (2 x pustules) + (comedones/4)~Decrease of ASI score are considered to be a better outcome"|baseline, 2nd week, 4th week and 8th week||||units on a scale||Standard Deviation|Mean
2599695|NCT02173054|Primary|Skin Tolerability: Transepidermal Water Loss (TEWL)|Skin tolerability was assessed by measuring TEWL with the Tewameter TM300|Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.||||g/m^2h||Standard Deviation|Mean
2599696|NCT02173054|Primary|Skin Tolerability: Skin Sebum Content and Skin Hydration|Skin tolerability was assessed by measuring the skin surface sebum content, skin hydration with the Sebumeter SM815 and Corneometer CM825, respectively|Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.||||µg/cm^2||Standard Deviation|Mean
2599697|NCT02173054|Secondary|Reduction of Severity of Acne|"Evaluation from mean counts of inflammatory, noninflammatory, and total acne lesions at baseline, and at 2, 4, and 8 weeks~Total acne lesions = inflammatory + noninflammatory acne lesions~Reduction of lesions counts are considered to be a better outcome"|baseline, 2nd week, 4th week and 8th week||||Lesions||Standard Deviation|Mean
2599698|NCT02173054|Primary|Reduction of Undesirable Effects|"Undesirable effects were evaluated from skin's condition/signs(erythema, dryness and scaling) are evaluated by dermatologist. (none; mild; moderate; severe) and subject interview/symptoms(stinging/burning and pruritis) are evaluated by participants.(none; mild; moderate; severe). There were assessed at 2nd week, 4th week, and 8th week.~The worst score of each parameter which was defined as the worst local tolerance score is demonstrated and compared among 3 groups as shown."|2nd week, 4th week, and 8th week|The reasons for drop out were lack of compliance (n=1, group A: adapalene gel alone) and consent withdrawal at patient's request (n=1, group C: adapalene with Eucerin)|||participants|||Number
2599699|NCT02172820|Other Pre-specified|Costs of Attending Care|Costs to the patient of attending care (transportation, child/elder care, missed wages) will be calculated from study entry to one year follow-up.|Intake to 1 year follow-up|||||||
2599700|NCT02172820|Other Pre-specified|Health Care Costs|Health care costs (cost of delivering care at the cardiac rehabilitation clinic as well as hospital costs) will be calculated from study entry to one year follow-up.|From intake to one year follow-up|||||||
2599701|NCT02172820|Other Pre-specified|Maintenance of Mental Health/Cognition Scores Following Intervention.|Changes in measures of mental health (Beck Depression Inventory, Adult Self-Report) as well as changes in measures of executive function (Trail Making and Tower tasks, Delay Discounting, Time Perspective Questionnaire, Stop Signal Task, Behavior Rating Inventory of Executive Function) will be measured from completion of intervention (4 months) to 8 months later (1 year follow-up).|4 months and 1 year.|||||||
2599702|NCT02172820|Other Pre-specified|Maintenance of Physical Health Gains Following Intervention.|Changes in measures of physical health and fitness (peak oxygen uptake, metabolic equivalents, waist circumference, BMI, treadmill time, smoking status, perceived quality of life) will be measured from completion of intervention (4 months) to 8 months later (1 year follow-up).|4 months and 1 year.|||||||
2599703|NCT02172820|Secondary|Changes in Mental Health/Cognition|The Achenbach System of Empirically Based Assessment (ASEABA) is an integrated system of multi-informant assessments, including self-reports, to measure adaptive functioning and problems. The problem items have been factor-analytically reduced to 8 syndrome scales that are consistent across age, informant and culture. Higher scores represent higher symptoms (e.g. emotional/behavioral problems). The Stop Signal Reaction Time (SSRT) task measures the ability to inhibit incorrect responses. Lower scores represent a better ability to inhibit reactions. The BRIEF-A is a rating scale developed to look at everyday behaviors associated with specific domains of executive functions in adults ages 18-90.T-scores (standardized scores) are used to interpret the individual's level of executive functioning (EF). Higher scores represent more self-reported problems. A score of 50 represents the mean.A difference of 10 from the mean indicates a difference of one standard deviation (SD).|Changes in socio-cognitive measures will be measures from intake to completion of intervention (4 months)||||percentage of change||Full Range|Mean
2599704|NCT02172820|Secondary|Change in Physical Health|Secondary outcomes included changes between baseline and 4-month assessment in fitness (peak oxygen uptake directly measured by expired gas analysis or estimated by metabolic equivalents), body composition (body mass index, waist circumference), and quality of life (MacNew).The MacNew was designed to evaluate how daily activities and physical,emotional and social functioning are affected by heart disease and its treatment. It consists of 27 questions grouped into 3 domains: physical, mental and social functioning. Both subscales and summary score are interpreted as scores between 1 and 7; higher scores are better, and a change of at least 0.5 is a useful indicator of the minimal important difference.Changes over time were assessed using paired differences in scores from intake to four months. Due to non-normal distributions, Wilcoxon Signed Rank Test was used. Contributions of other variables to changes in secondary outcomes were examined using analyses of covariance.|Intake, 4 months|Despite having 65 subjects in each of the two groups (financial incentives and control), only 55 and 57 subjects were analyzed respectively. Not every subject completed the initial intake (lost contact with 10 and 8 subjects, respectively).|||percentage of change||Full Range|Mean
2599705|NCT02172820|Primary|Attendance at Cardiac Rehabilitation Exercise Sessions|The number of patients who completed cardiac rehabilitation (CR) as defined as greater than or equal to 30 sessions. Must have been completed within 4 months of the entry stress test.|Within 4 months of initial stress test||||Participants|||Count of Participants
2599706|NCT02172755|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point|"Single-dose period: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.~Multiple-dose period: from Day 5 to Day 11 inclusive, early in the morning, before the daily dose (for trough levels).~Day 12: pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose.~BIA 2-194, BIA 2-195, and oxcarbazepine are metabolites of BIA 2-093"|Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose From Day 5 to Day 11 inclusive, before the daily dose (for trough levels). On Day 12, pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours p||||ng.h/mL||Standard Deviation|Mean
2599707|NCT02172755|Secondary|Tmax - Time of Maximum Observed Concentration|"Single-dose period: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.~Multiple-dose period: from Day 5 to Day 11 inclusive, early in the morning, before the daily dose (for trough levels).~Day 12: pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose.~BIA 2-194, BIA 2-195, and oxcarbazepine are metabolites of BIA 2-093"|Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose From Day 5 to Day 11 inclusive, before the daily dose (for trough levels). On Day 12, pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours p||||hours||Standard Deviation|Mean
2599708|NCT02172755|Primary|Maximum Drug Concentration (Cmax)|"Single-dose period: Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose.~Multiple-dose period: from Day 5 to Day 11 inclusive, early in the morning, before the daily dose (for trough levels).~Day 12: pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-last dose.~BIA 2-194, BIA 2-195, and oxcarbazepine are metabolites of BIA 2-093"|Day 1 at pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours post-dose From Day 5 to Day 11 inclusive, before the daily dose (for trough levels). On Day 12, pre-dose, and ½, 1, 1½, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours p||||ng/mL||Standard Deviation|Mean
2599709|NCT02172742|Secondary|AUCτ - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h|Steady-state Area Under the Plasma Concentration-time Profile Over 24 h of BIA 2-005 (BIA 2-093 metabolite) and Digoxin|Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose||||ng*h/mL||Standard Deviation|Mean
2599710|NCT02172742|Secondary|Tmax - Time of Occurrence of Cmax at Steady-state|Time of Occurrence of Cmax Maximum steady-state plasma concentration of BIA 2-005 (BIA 2-093 metabolite) and Digoxin|Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose||||hours||Full Range|Median
2599711|NCT02172742|Primary|Cmax - Maximum Steady-state Plasma Concentration|Cmax - Maximum steady-state plasma concentration of BIA 2-005 (BIA 2-093 metabolite) and Digoxin|Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose||||ng/mL||Standard Deviation|Mean
2599712|NCT02172664|Secondary|Number of Restoration Margins Marked as Stained or Discolored|The secondary outcome measure was the presence of discoloration of restoration margins as determined by blinded evaluators.|6, 12, 24 months|Available number of participants at each time point are reported.|||Non-carious cervical lesions|Non-carious cervical lesions||Count of Units
2599713|NCT02172664|Primary|Retention of Restorations|The primary outcome measure will be restoration retention. In these non-retentive dental lesions, the adhesive will be the only mode of retention. Failure of the adhesive would result in loss of the restoration.|6, 12, 24 months|Available number of participants at each time point are reported.|||Non-carious cervical lesions|Non-carious cervical lesions||Count of Units
2599714|NCT02172625|Secondary|Superoxide Dismutase (SOD)|Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC [Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. This is another protective antioxidant enzyme measured from whole blood. The SOD enzymatic assay from Genova Diagnostics is designed to measure the activity of the SOD enzyme in the cytosol. The SOD assay is designed to measure the activity of SOD enzyme from whole blood. The SOD activity is determined spectrophotometrically based on the ability of the SOD compound to reduce reactive oxygen species in an enzymatic reaction necessary for the produc tion of an optically active compound.|Baseline, 30 days, 57 days, and 88 days||||U/g Hb x 1000||Standard Deviation|Mean
2599715|NCT02172625|Secondary|Whole Blood Glutathione Content (GSH)|Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC [Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. The total whole blood glutathione assay is designed to measure the level of glutathione in whole blood. The samples is first completely lysed and proteins are precipitated. The supernatant is then reduced and combined with a spectrophotometrically reactive compound which generates a detectable absorption peak. When compared to known concentrations of glutathione under the same reaction conditions a determination of glutathione levels in blood is determined.|Baseline and 88 (SD 4) days. All pre-exercise values.|Runners from the Louisville, KY, USA, community|||umol/L x 10||Standard Deviation|Mean
2599716|NCT02172625|Secondary|Total Antioxidant Capacity (TAC)|Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC[Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. Total antioxidant capacity (TAC). The TAC measures the overall collective power of the blood to neutralize free radicals. Specifically, the TAC assay measures the antioxidant capacity of a serum sample via the ability of the antioxidants within the sample to neutralize a spectrophotometrically active compound that is optically active when oxidized. The decrease in color intensity of the compound when compared to the standard, Trolox, under the same reaction conditions is equivalent to the serum antioxidant capacity of the serum sample.|Baseline and 88 (SD 4) days. All pre-exercise values.|Runners from the Louisville, KY, USA, community|||mmol/L||Standard Deviation|Mean
2599717|NCT02172625|Secondary|Quality of Life as Assessed by the World Health Organization Quality of Life Questionnaire (Brief)|"This is a questionnaire that assessed quality of life across 4 domains over the supplementation period.~Physical Health domain: Scores range from 7 (lowest) to 35 (best, most favorable).~Psychological Health Domain: Scores range from 6 (lowest) to 30 (best, most favorable).~Social Relationships Domain: Scores range from 3 (lowest) to 15 (best, most favorable).~Environment Domain: Scores range from 8 (lowest) to 40 (best, most favorable)."|Baseline, 30 days, 57 days, and 88 days|Healthy community runners.|||units on a scale||Standard Deviation|Mean
2599936|NCT02169219|Primary|Complete Remission|We examined whether an 8-week glucocorticoid course in combination with rituximab (RTX) would induce disease remission in patients with AAV. The primary outcome was disease remission off steroids at 6 months.|6 months||||Participants|||Count of Participants
2599718|NCT02172625|Secondary|Glutathione Peroxidase (GPX)|Blood was collected in vacuum-sealed tubes designed to contain and preserve specimens in a manner appropriate for their respective analysis and shipped to Geneva Diagnostics for analysis using proprietary methodology (Oxidative Stress Analysis 2.0, Blood). Genova Diagnostics is a global, fully accredited clinical laboratory, located in Asheville, NC [Licensed by Clinical Laboratory Improvement Amendments (CLIA) Certification number #34D0655571]. Glutathione peroxidase (GPX). This is a measure of glutathione peroxidase activity in red blood cell lysates sampled fromwhole blood. The level of GPX in the sample is determined spectrophotometrically based on the ability of the compound to catalyze a reduction reac- tion in the presence of glutathione. The change in the absorption level of the substrate is then utilized to determine the level of GPX present in the sample. The result is expressed as units of GPX relative to the gram amount of hemoglobin in the sample.|Baseline, 30 days, 57 days, and 88 days||||U/g Hb||Standard Deviation|Mean
2599719|NCT02172625|Primary|Lipid Peroxides (TBARS)|Lipid peroxides (TBARS) is a measure of oxidative damage in the blood. The full report can be found here: http://dx.doi.org/10.1371/journal.pone.0160559|Baseline, 30 days, 57 days, and 88 days|The values reported here are the values in a fasted state. The full report can be found here: http://dx.doi.org/10.1371/journal.pone.0160559|||umol/L||Standard Deviation|Mean
2599720|NCT02172625|Primary|5-km Running Time|5-km running performance time was measured twice at the beginning of the study, and then once post-supplementation. The best 5 km time from both initial sessions was counted as the baseline 5-km time. The full report can be found here: http://dx.doi.org/10.1371/journal.pone.0160559|Baseline and 88 (SD 4) days|Runners from the Louisville, KY, USA, community|||minutes||Standard Deviation|Mean
2599721|NCT02172040|Secondary|Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday) - Secondary Endpoint||Baseline and 2 weeks|ITT Population as described for primary outcome|||mmHg||Standard Deviation|Mean
2599722|NCT02172040|Secondary|Mean Log-transformed Celecoxib Plasma Concentration||24 hours post-dose on Day 14|PK population: subset of overall trial population, consisting of participants at Investigational sites capable of obtaining PK blood samples in a protected light environment. No celecoxib PK statistical analyses were performed for the PK participants in the amlodipine+placebo and placebo+placebo arms.|||log(ng/mL)||Standard Deviation|Mean
2599723|NCT02172040|Secondary|Mean Log-transformed Amlodipine Plasma Concentration||24 hours post-dose on Day 14|PK population: subset of overall trial population, consisting of participants at Investigational sites capable of obtaining PK blood samples in a protected light environment. No amlodipine PK statistical analyses were performed for the PK participants in the placebo+celecoxib and placebo+placebo arms.|||log(pg/mL)||Standard Deviation|Mean
2599724|NCT02172040|Secondary|Mean Non-transformed Celecoxib Plasma Concentration||24 hours post-dose on Day 14|PK population: subset of overall trial population, consisting of participants at Investigational sites capable of obtaining PK blood samples in a protected light environment. No celecoxib PK statistical analyses were performed for the PK participants in the amlodipine+placebo and placebo+placebo arms.|||ng/mL||Standard Deviation|Mean
2599725|NCT02172040|Secondary|Mean Non-transformed Amlodipine Plasma Concentration||24 hours post-dose on Day 14|Pharmacokinetic (PK) population: subset of overall trial population, consisting of participants at Investigational sites capable of obtaining PK blood samples in a protected light environment. No amlodipine PK statistical analyses were performed for the PK participants in the placebo+celecoxib and placebo+placebo arms.|||pg/mL||Standard Deviation|Mean
2599726|NCT02172040|Secondary|Mean Change in Average Night-time (01:00 to 06:00) Ambulatory Diastolic Blood Pressure (DBPnight)||Baseline and 2 weeks|ITT Population as defined for primary outcome|||mmHg||Standard Deviation|Mean
2599727|NCT02172040|Secondary|Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Diastolic Blood Pressure (DBPday)||Baseline and 2 weeks|ITT Population as described for primary outcome|||mmHg||Standard Deviation|Mean
2599728|NCT02172040|Secondary|Mean Change in Average 24-hour Ambulatory Diastolic Blood Pressure (DBP24h)||Baseline and 2 weeks|ITT Population as described for primary outcome|||mmHg||Standard Deviation|Mean
2599729|NCT02172040|Secondary|Mean Change in Average Night-time (01:00 to 06:00) Ambulatory Systolic Blood Pressure (SBPnight)||Baseline and 2 weeks|ITT Population as described for primary outcome|||mmHg||Standard Deviation|Mean
2599730|NCT02172040|Secondary|Mean Change in Average 24-hour Ambulatory Systolic Blood Pressure (SBP24h)||Baseline and 2 weeks|ITT population as described for primary outcome|||mmHg||Standard Deviation|Mean
2599731|NCT02172040|Primary|Frequency of Adverse Events (Number of Participants Affected/Number of Participants at Risk)|Including any untoward medical occurrence in a participant administered study drug, which do not necessarily have a causal relationship with the study drug [i.e., any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug].|1 month|Safety population: all randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2599732|NCT02172040|Primary|Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday) - Primary Endpoint||Baseline and 2 weeks|Intent-to-treat (ITT): All randomized participants who received at least 1 dose of study drug and had at least a valid baseline ambulatory blood pressure monitor measurement (ABPM) and either: a) a valid Day 13-14 ABPM, where participant completed treatment or b) a valid Day 6-7 or Day 0-1 ABPM, where participant was withdrawn early.|||mmHg||Standard Deviation|Mean
2599733|NCT02171819|Secondary|Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose||Days 0, 21, and 42||||Titers||95% Confidence Interval|Mean
2599734|NCT02171819|Secondary|Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose||Days 0, 21 and 42|Per-protocol analysis set--The Per-Protocol Analysis Set (PPAS) contained all study subjects who received 2 doses of vaccine or placebo and completed the Day 42 visit without major protocol violations that were determined to potentially interfere with immune response to the study vaccine.|||Titers||95% Confidence Interval|Mean
2599735|NCT02171819|Secondary|The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2||Days 21 and 42|Per-protocol analysis set--The Per-Protocol Analysis Set (PPAS) contained all study subjects who received 2 doses of vaccine or placebo and completed the Day 42 visit without major protocol violations that were determined to potentially interfere with immune response to the study vaccine.|||Participants|||Count of Participants
2599736|NCT02171819|Secondary|The Proportion of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer ≥ 1:40 Pre-vaccination (Day 0) to Post 2nd Vaccination (Day 49)||Day 0 to Day 49|Per-protocol analysis set--The Per-Protocol Analysis Set (PPAS) contained all study subjects who received 2 doses of vaccine or placebo and completed the Day 42 visit without major protocol violations that were determined to potentially interfere with immune response to the study vaccine.|||Participants|||Count of Participants
2599737|NCT02171819|Primary|All Serious Adverse Events (SAEs) Occurring Within 3 Weeks of Receipt of Any Dose|Summary data. Data presented are after 1st and 2nd injections combined. Please see AE reporting section of this report for full details.|Within 3 weeks of any injection|Table 14.2.2.3.1 Summary of Serious Unsolicited Adverse Events by System Organ Class and Preferred Term (After 1st and 2nd Vaccination Combined) Intention-to-Treat Population|||Participants|||Count of Participants
2599738|NCT02171819|Primary|Number of Participants With at Least One Unsolicited AE|Summary of number of participants with at least one unsolicited AE after 1st and 2nd vaccination combined. Please see the adverse event section of this report for full details.|Within 7 weeks of injection|"Intent to treat population. Please see more detail in the AE section of this posting.~Table 14.2.1.2.1 Summary of Unsolicited Adverse Events by System Organ Class and Preferred Term (After 1st and 2nd Vaccination Combined) Intention-to-Treat Population"|||Participants|||Count of Participants
2599739|NCT02171819|Primary|Number of Participants With at Least One Solicted Reactogenicity After Both Injections|"Data presented are after 1st and 2nd vaccination combined. Solicted reactogenicity are local and systemic events that are expected after injection and specifically asked of the participant. Only reported reactogenicity is presented. If not shown, then no participant reported that reaction in any study group.~Local reactions are redness, swelling, pain, tenderness, and hardness. Systemic reactions are actual and subjective fever, chills, cough, difficulty breathing, runny nose, nasal congestion, sore throat, hoarseness of voice, headache, confusion. convulsions/seizures, fatigue/malaise, muscle aches (generalized), joint pain, pink or red eyes, sore eyes, itchy eyes, drainage from eyes. ear pain or discharge, rash, abdominal pain, diarrhea, vomiting, and jaundice."|Within 7 days after injection|Participants who were randomized and received study injections|||Participants|||Count of Participants
2599740|NCT02171819|Primary|Immediate Reactions Occurring Within 60 Minutes of Administration of Any Dose|Data presented are after 1st and 2nd vaccination combined. All participants were observed for immediate reactions for 60 minutes after administration of study product, with appropriate medical treatment readily available in case of an anaphylactic reaction following the administration of study product.|60 min post injection|Intent to treat population.|||Participants|||Count of Participants
2599741|NCT02171611|Secondary|Assessment of Tolerability by Investigator.|Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad.|From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.|Treated Set|||Percentage of Participants|||Number
2599742|NCT02171611|Secondary|Percentage of Participants With Drug-related Adverse Events|Percentage of participants with investigator defined drug−releated Adverse events.|From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.|Treated set|||Percentage of participants|||Number
2599743|NCT02171611|Secondary|Percentage of Participants With Findings in Physical Examination, Vital Signs , Pulse Rate (PR)), 12-lead ECG, Clinical Laboratory Tests.|"Percentage of participants with findings in Physical examination, Vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram), Clinical laboratory tests (haematology, clinical chemistry and urinalysis). Relevant findings or worsening of baseline conditions were reported as Adverse events.~There were no clinically relevant finding reported for Physical examination, Vital signs (blood pressure, pulse rate), 12-lead ECG and Clinical laboratory tests."|From first drug administration until 7 days after the last drug administration of Dabigatran, ie., up to 10 days.|Treated Set|||Percentage of participants|||Number
2599744|NCT02171611|Secondary|Vz/F for Free Dabigatran|Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for free dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||Liter||Geometric Coefficient of Variation|Geometric Mean
2599745|NCT02171611|Secondary|Vz/F for Total Dabigatran|Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||Liter||Geometric Coefficient of Variation|Geometric Mean
2599746|NCT02171611|Secondary|CL/F for Free Dabigatran|Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for free dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||mL (milliliter)/min (minute)||Geometric Coefficient of Variation|Geometric Mean
2599747|NCT02171611|Secondary|CL/F for Total Dabigatran|Apparent clearance of the analyte in plasma following extravascular administration (CL/F) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||mL (milliliter)/min (minute)||Geometric Coefficient of Variation|Geometric Mean
2599748|NCT02171611|Secondary|MRTpo for Free Dabigatran|Mean residence time of the analyte in the body after po administration (MRTpo) for free dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||hour||Geometric Coefficient of Variation|Geometric Mean
2599749|NCT02171611|Secondary|MRTpo for Total Dabigatran|Mean residence time of the analyte in the body after po administration (MRTpo) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||hour||Geometric Coefficient of Variation|Geometric Mean
2599937|NCT02169115|Secondary|To Assess the Safety of Omalizumab in UF Patients|Safety of patients treated with omalizumab: This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting|112 days|||||||
2599750|NCT02171611|Secondary|t1/2 for Free Dabigatran|Terminal half-life of the analyte in plasma (t1/2) for free dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||hour||Geometric Coefficient of Variation|Geometric Mean
2599751|NCT02171611|Secondary|t1/2 for Total Dabigatran|Terminal half-life of the analyte in plasma (t1/2) for total dabigatran|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||hour||Geometric Coefficient of Variation|Geometric Mean
2599752|NCT02171611|Secondary|λz for Free Dabigatran||-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||1/hour||Geometric Coefficient of Variation|Geometric Mean
2599753|NCT02171611|Secondary|λz for Total Dabigatran|Terminal rate constant in plasma (λz) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||1/hour||Geometric Coefficient of Variation|Geometric Mean
2599754|NCT02171611|Secondary|Tmax for Free Dabigatran|Time from dosing to the maximum concentration of the analyte in plasma (tmax) for free dabigatran|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||hour||Full Range|Median
2599755|NCT02171611|Secondary|Tmax for Total Dabigatran|Time from dosing to the maximum concentration of the analyte in plasma (tmax) for total dabigatran|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||hour||Full Range|Median
2599756|NCT02171611|Secondary|AUC0-tz for Free Dabigatran|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for free dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2599757|NCT02171611|Secondary|AUC0-tz for Total Dabigatran|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2599758|NCT02171611|Primary|Cmax for Free Dabigatran|Maximum measured concentration of the analyte in plasma (Cmax) for free dabigatran|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2599759|NCT02171611|Primary|Cmax for Total Dabigatran|Maximum measured concentration of the analyte in plasma (Cmax) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2599760|NCT02171611|Primary|AUC0-inf for Free Dabigatran|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for free dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|pharmacokinetic per-protocol set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2599761|NCT02171611|Primary|AUC0-inf for Total Dabigatran|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) for total dabigatran.|-0:30 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 2:30h, 3:00h, 3:30h, 4:00h, 6:00h, 8:00h, 12:00h, 24:00h, 36:00h and 48:00h after drug administration.|PK-Per protocol set (PK-PPS): This subject set included all subjects in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations with respect to the evaluation of relative bioavailability and who did not vomit at or before 2 times the median tmax.|||ng(nanogram)*h(hour)/mL(milliliter)||Geometric Coefficient of Variation|Geometric Mean
2599762|NCT02171260|Secondary|Number of Participants With Best Overall Response|Best Overall Response (BOR): best response recorded from start of study treatment until disease progression (PD) or recurrence based on response evaluation criteria in solid tumors (RECIST) version 1.1 for target and non-target lesions. Participants with evaluable disease were also eligible for assessment.|First dose of study drug (Baseline) up to approximately Cycle 8 (21-days treatment cycle)|The SAS included all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2599763|NCT02171260|Primary|Vd: Volume of Distribution for Eribulin Mesylate||Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose|The PAS included all participants who had sufficient PK data to derive at least one PK parameter. The PAS where data at pacified timepoints was available.|||milliliter||Standard Deviation|Mean
2599764|NCT02171260|Primary|CL: Clearance for Eribulin Mesylate||Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose|The PAS included all participants who had sufficient PK data to derive at least one PK parameter. The PAS where data at specified timepoints was available.|||milliliter per hour (mL/h)||Standard Deviation|Mean
2599765|NCT02171260|Primary|AUC 0-inf: Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time for Eribulin Mesylate||Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose|The PAS included all participants who had sufficient PK data to derive at least one PK parameter. The PAS where data at specified timepoints was available.|||h*ng/mL||Standard Deviation|Mean
2599938|NCT02169115|Secondary|To Assess Long-term Effects of Omalizumab in UF Patients|To assess long-term effects of omalizumab in UF patients, change in friction thresholds from day 70 (week 10) to day 112 (week 16) will be assessed|112 days|||||||
2599766|NCT02171260|Primary|AUC 0-t: Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for Eribulin Mesylate||Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose|The PAS included all participants who had sufficient PK data to derive at least one PK parameter.|||hour * nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
2599767|NCT02171260|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Eribulin Mesylate||Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose|The PAS included all participants who had sufficient PK data to derive at least one PK parameter.|||hours||Full Range|Median
2599768|NCT02171260|Primary|Cmax: Maximum Observed Plasma Concentration for Eribulin Mesylate||Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose|The PAS included all participants who had sufficient PK data to derive at least one PK parameter.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2599769|NCT02171260|Primary|T1/2: Terminal Half-life for Eribulin Mesylate||Day 1 predose and at 10, 30 minutes, 1, 2, 4, 6, 24, 48, 72, 96 or 120 hours post-dose|The pharmacokinetic analysis set (PAS) included all participants who had sufficient PK data to derive at least one PK parameter. The PAS where data at specified timepoints was available.|||hours||Full Range|Median
2599770|NCT02171260|Primary|Number of Participants With Clinically Significant Electrocardiogram (EKG)||First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)|The SAS included all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2599771|NCT02171260|Primary|Number of Participants With Clinically Significant Vital Sign Values||First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)|The SAS included all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2599772|NCT02171260|Primary|Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values||First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)|The SAS included all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2599773|NCT02171260|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|TEAEs were defined as those adverse events (AEs) that occurred (or worsened, if present at Baseline) after the first dose of study drug through 30 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. A SAE was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect.|First dose of study drug (Baseline) up to 30 days after last dose of study drug (Cycle 8 Day 38)|The SAS included all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2599774|NCT02171260|Primary|Maximum Tolerated Dose (MTD) of Eribulin Mesylate|MTD: maximum dose at which <one third participants had DLT in Cycle 1. DLT: Grade 3/4 drug-related non hematological toxicity (except Grade 3 nausea, vomiting of <3 days, Grade 3 liver enzyme elevation with alanine transaminase/aspartate transaminase and gamma glutamyl transferase that returned to Grade <=1 or baseline prior to next dose; Grade 3 fever, infection, hypophosphatemia, hypokalemia, hypocalcemia/hypomagnesemia responsive to oral supplementation). Non-hematological toxicity causing >=14 days delay between treatment cycles. Haematological DLTs included: Grade 4 neutropenia/platelets<75,000/mm^3 on Day 8 that does not resolve to absolute neutrophil count >=750/mm^3 and platelets>=75,000/mm^3 by Day 11, neutropenia for >7 days; platelet count <25,000/mm^3, or required platelet transfusion, on 2 separate days within 7-day period;Grade 3 thrombocytopenia complicated by bleeding and/or required platelet transfusion;myelosuppression causing >14 days delay between treatment cycles.|First dose of study drug (Baseline) up to Cycle 1 Day 21|The dose evaluable set (DES) included all participants who were judged as DLT evaluable as recorded in the database. In order to be DLT evaluable, all participants had to complete Cycle 1.|||mg/m^2|||Number
2599775|NCT02171247|Primary|Attenuation of the Ascending Aorta and Coronary Arteries|The investigator will measure the length of visualized coronary artery for the left anterior descending, left circumflex and right coronary arteries as a way of quantifying visualization of distal coronary segments.|during scan, approximately 3 hours||||CNR||Standard Deviation|Mean
2599776|NCT02171247|Primary|Motion Artifact|The outcome will be measured by individual scores. The scores from multiple readers will be averaged.|during scan, approximately 3 hours|Data was not collected and therefore not analysed||||||
2599777|NCT02171247|Primary|Image Quality|Depiction of Branch Vessels - coronary branch depiction was performed as consensus decisions of two blinded radiologists. Criteria used was abscence or presence of vessels.|during scan, approximately 3 hours||||% of coronary branches visualized|||Number
2599778|NCT02171247|Primary|Contrast to Noise Ratio|Contrast-to-noise ratios (CNRs) were calculated as follows: CNR = (vascular attenuation − myocardium attenuation) / SD of mean noise attenuation.|during scan, approximately 3 hours||||CNR||Standard Deviation|Mean
2599779|NCT02171234|Primary|Total Number of Adverse Events|Total Number of Adverse Events.|up to 20 weeks||||Total Number of AE|||Number
2599780|NCT02171234|Secondary|AUC0-τ|"AUC0-τ - Area under the plasma concentration time curve to last measurable time point~Day 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose"|Day 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose||||ng.h/ml||Standard Deviation|Mean
2599781|NCT02171234|Secondary|Cmax|Cmax - Maximum observed plasma concentration|Day 1 and Day 8||||ng/ml||Standard Error|Mean
2599782|NCT02171195|Primary|Total Number of Adverse Events|An adverse event was defined as any undesirable event occurring to a subject during the study, whether or not related to the investigational product|up to 20 weeks||||Number of Adverse Events|||Number
2599822|NCT02170532|Secondary|Change in Tremor Assessment Measured by a Scale|Tremor assessment will be made on outstretched hands (0 = none, 1+ = fine tremor, barely perceptible, 2+ = obvious tremor).|Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment|Data for this outcome measure is not reported because the data was not collected.||||||
2599783|NCT02171130|Other Pre-specified|Number of Participants With Treatment-Emergent Glucagon Anti-Drug Antibodies (ADA)|Treatment-Emergent ADA includes treatment-induced ADA ('Not Detected' ADA at baseline and at least one post-baseline 'Detected' ADA sample with a corresponding titer of (1:20) and treatment-boosted ADA (with 'Detected' ADA at baseline and at least one post-baseline 'Detected' ADA sample with a corresponding titer that is at least 4-fold higher than the baseline titer.|Baseline and End of Study (6 months)|Enrolled participants who had antibody sample at both baseline and post-baseline.|||percentage of participants|||Number
2599784|NCT02171130|Other Pre-specified|Blood Glucose Levels Over Time|The participants' blood glucose level was measured by the caregiver using a glucometer at baseline (just prior to dosing and right after the study drug administration), 15, 30 and 45 minutes after nasal glucagon administration.|Baseline (just prior to dosing or right after study drug administration) , 15, 30 and 45 minutes after drug administration for an episode of hypoglycemia|Enrolled participants received at least 1 dose of the study drug with evaluable hypoglycemic event. Events requiring additional medical assistance or rescue therapy within 30 minutes of study drug administration and participants from a GCP non-compliant site were excluded.|||milligram/deciliter (mg/dL)|Total Number of Hypoglycemic Events|Standard Deviation|Mean
2599785|NCT02171130|Secondary|Percentage of Participants With Adverse Events (AEs) Reported Through the Nasal Score Questionnaire|"Adverse events solicited through the Nasal Score Questionnaire included: runny nose, nasal congestion (nostrils plugged), nasal itching, sneezing, watery eyes, itchy eyes, redness of eyes, itching of ears, itching of throat, and other.~A summary of other nonserious AEs, and all Serious Adverse Events (SAEs), regardless of causality, is located in the Reported Adverse Events section."|Within 2 hours of full recovery from a hypoglycemic event|Eligible enrolled participants who experienced at least 1 hypoglycemic event and received at least 1 dose of study drug.|||percentage of participants|||Number
2599786|NCT02171130|Secondary|Assessment of Ease-of-use of Dry-Mist Nasal Glucagon as Determined by Completion of Questionnaires by the Caregiver|Measurement for Degree of difficulty: opening the kit, Degree of difficulty: understanding the instructions on how to use the kit, Degree of difficulty: administering the medication into the nostril, Degree of satisfaction is 1 (Very Difficult) to 7 (Very Easy). Measurement for Dry Mist Nasal Glucagon will be easy to teach other caregivers, Nasal formulation of glucagon is less intimidating for caregivers, Nasal Glucagon is easy to carry and would be willing to carry it, nasal delivery of glucagon is preferable. Level of agreement 1 (Strongly Disagree) to 7 (Strongly Agree).|After each drug administration for an episode of hypoglycemia|Eligible enrolled participants who experienced at least 1 hypoglycemic event and received at least 1 dose of study drug. Participants from the GCP non-compliant site and participants who were impacted by a clinical material issue which might have led to under-dose, were considered ineligible thus excluded from this population.|||Total Number of Events|Total Number of Events||Count of Units
2599787|NCT02171130|Primary|Percentage of Participants Awakening or Returning to a Normal Status Within 30 Minutes Following Studied Drug of Administration|"Responses to questions completed by the caregiver were used to assess this outcome.~An episode of severe hypoglycemia was defined as an episode wherein the person with diabetes is clinically incapacitated to the point where the person requires third-party assistance to treat the hypoglycemia. An episode of moderate hypoglycemia episode was defined as an episode wherein the person with diabetes was showing signs of neuroglycopenia and had a glucometer reading of approximately 60 milligrams per deciliter (mg/dL) (3.3 millimoles per liter [mmol/L]) or less based on a blood sample taken at or near the time of treatment."|Within 30 minutes after each drug administration for an episode of hypoglycemia|Enrolled participants received at least 1 dose of the study drug with evaluable hypoglycemic event. Events requiring additional medical assistance or rescue therapy within 30 minutes of study drug administration and participants from a Good Clinical Practice (GCP) non-compliant site were excluded.|||percentage of participants|||Number
2599788|NCT02170870|Secondary|Rate of Gastric Emptying (GE t 1/2) in Patients With Diabetes Mellitus (DM) or Non-ulcer Dyspepsia (NUD) Compared to Placebo|The time for half of the ingested solids or liquids to leave the stomach. Following a meal consisting of two eggs labeled with technetium Tc 99m sulfur colloid (1 mCi) served on one slice of bread with milk labeled with indium In111 diethylenetriaminepentaacetate (0.1 mCi), gastric emptying of solids and liquids was assessed with scintigraphy. Rapid emptying is defined as ≥ 36% emptied at one hour and delayed emptying is defined as < 76% emptied at four hours. Normal emptying is defined as amount less than rapid emptying definition but greater than delayed emptying definition.|Day 1||||Participants|||Count of Participants
2599789|NCT02170870|Primary|Mean Intestinal Chemosensitivity to Lipids Perfusion|Intestinal chemosensitivity was recorded by evaluating symptoms during duodenal lipid infusion (0.5 gm/mL diluted in water to 222 mL) and placebo or the glucagon like peptide 1 (GLP-1) receptor antagonist exendin 9-39 over 2 hours. Participants reported the severity of 6 symptoms (nausea, fullness, bloating, abdominal pain, belching, and burning) at 15 minute intervals using a Visual Analogue Scale (VAS) marked 0 (minimum value) - 4 (maximum value): absent (0), light (1), moderate (2), severe (3) and intolerable(4). The scores recorded for nausea, fullness, bloating, and abdominal pain over the 2 hour infusion were averaged and reported as the mean symptom score. Higher scores mean a worse outcome.|Day 1, approximately 2 hours after infusion|Functional Dyspepsia arm - enteral lipid infusion was not performed because a nasoduodenal tube could not be placed in 2 functional dyspepsia placebo subjects and 3 functional dyspepsia exendin 9-39 subjects.|||score on a scale||Standard Deviation|Mean
2599790|NCT02170779|Secondary|Beck Depression Inventory II (BDI II)|"The BDI-II is a standardized self-report questionnaire to quantify depression.~The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Answers to 21 questions added together. Higher scores indicate greater depression. Lowest possible score is a 0 whereas highest 63."|at average of 4 months||||units on a scale||Standard Deviation|Mean
2599791|NCT02170779|Secondary|Multiple Sclerosis Spasticity Scale - 88 (MSSS-88)|"The modified MSSS-88 is a standardized self-report questionnaire to quantify subject's impact of the effects of spasticity.~The 88 questions each have a possible score of 1-4. All questions are totaled for a final total scores. Higher scores indicate greater spasticity. The lowest score is 88 and the highest possible is 352."|at average of 4 months||||units on a scale||Standard Deviation|Mean
2599823|NCT02170532|Secondary|Change in Heart Rate||Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment|Data for this outcome measure is not reported because the data was not collected.||||||
2599792|NCT02170779|Secondary|Spasticity Measured by the Modified Ashworth Scale|"The modified Ashworth Scale is a standard clinical and research method to quantify spasticity.~Each of the 6 leg groups is given a scale of 0-4.~0 - Normal. No increase in muscle tone.~- Mild. Barely increased muscle tone. (catch)~- Moderate. Moderately increased muscle tone that can be overcome and full range of motion is possible. (catch and resistance)~- Severe. Severely increased muscle tone that is extremely difficult to overcome and full range of motion is not possible. (resistance and stop)~- Contracted. All groups are summed for a total score for each side of the body. Higher scores indicate greater spasticity. Lowest possible score is a 0 whereas the highest possible score for each side is 24."|at average of 4 months||||units on a scale||Standard Deviation|Mean
2599793|NCT02170779|Secondary|Multiple Sclerosis Impact Scale (MSIS-29)|"The MSIS-29 is designed to measure the physical and psychological impact of MS.~Each subscale summed separately. No total calculated. Scores transformed to have a range of 0-100. Lower scores indicate less impact, higher scores indicate higher impact."|at average of 4 months||||units on a scale||Standard Deviation|Mean
2599794|NCT02170779|Secondary|Modified Fatigue Impact Scale (MFIS)|This self-report retrospective questionnaire measures fatigue symptoms. It consists of 21 items scored 0-4 for a total score between 0 and 84 and has a coefficient alpha of 0.81. Lower scores on the MFIS indicate less fatigue.|at average of 4 months||||units on a scale||Standard Deviation|Mean
2599795|NCT02170779|Secondary|2 Minute Walk Test|The subject walks without assistance of another person for 2 minutes. The distance in feet the individual was able to walk in 2 minutes is then measured.|at average of 4 months|One subject was unable to complete this physical assessment at the visit.|||feet||Standard Deviation|Mean
2599796|NCT02170779|Secondary|Timed up and go Test|"The Timed Up and Go (TUG) test measures the time in seconds it takes to get up from a chair, walk 10 feet, turn around and return to sit in the chair.~The best score of the two attempts was analyzed."|at average of 4 months|One subject was unable to complete this physical assessment at the visit.|||seconds||Standard Deviation|Mean
2599797|NCT02170779|Secondary|Timed 25 Foot Walk|"The time to walk 25 feet is strongly related to its ordinal counterpart the Ambulation Index (Spearman r=0.91) without the variability the ordinal scale reflects.~The time is measured and recorded in seconds how long it takes for the participant to walk 25 feet."|at average of 4 months|One subject was unable to complete this physical assessment at the visit.|||seconds||Standard Deviation|Mean
2599798|NCT02170779|Primary|MS Walking Scale-12 (MSWS-12)|"The MSWS-12 is a clinically validated and reliable tool that is flexible and simple enough to use clinically and in research. It captures patients' perspectives on their ambulatory disability on the following: standing, ability to run, need for support, moving around the home, concentration needed to walk, walking speed, maintaining balance, climbing stairs, walking distance, effort needed to walk, ability to walk, and gait. It is simple to administer and responsive to changes in patient performance over time.~Individual items are scored on a 5 point Likert scale: 1 (Not at all), 2 (A little), 3 (Moderately), 4 (Quite a bit), 5 (Extremely). A total score is generated and reported on a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12, or 48), and multiplying. Higher values represent a worse outcome and greater disability."|at average of 4 months||||units on a scale||Standard Deviation|Mean
2599799|NCT02170727|Secondary|Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities|Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the selected Grade 3 - 4 laboratory abnormalities (including hematologic and liver function, based on DAIDS criteria) was conducted.|Up to post treatment week 4|Subgroup analysis set included participants who received at least 1 dose of study therapy.|||Participants|||Count of Participants
2599800|NCT02170727|Secondary|Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs|Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the frequency of SAEs, discontinuations due to AEs was conducted.|Up to post treatment week 4|Subgroup analysis set included participants who received at least 1 dose of study therapy.|||Participants|||Count of Participants
2599801|NCT02170727|Secondary|Number of Participants With Selected Grade 3/4 Laboratory Abnormalities|Rates of selected Grade 3 - 4 laboratory abnormalities on treatment in each cohort was estimated|Post treatment week 4|Safety analysis population included participants who received at least 1 dose of study therapy.|||Participants|||Count of Participants
2599802|NCT02170727|Secondary|Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12|Proportion of Cirrhotic and Non Cirrhotic Participants who Achieved SVR12 were reported.|Post treatment Week 12|It included enrolled participants who received at least 1 dose of study therapy. SVR12 is based on Next Value Carried Backwards approach.|||Percentage of Participants|||Number
2599803|NCT02170727|Secondary|Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype)|Proportion of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported.|Post treatment Week 12|It included enrolled participants who received at least 1 dose of study therapy. SVR12 is based on Next Value Carried Backwards approach|||Percentage of Participants|||Number
2599804|NCT02170727|Secondary|Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b|Percentage of subjects in each cohort who achieved SVR12 associated with HCV genotype subtype 1a vs 1b were reported.|Post treatment week 12|It included enrolled participants who received at least 1 dose of study therapy. Here, N signifies number of participants evaluable for the outcome measure, 'n' signifies number of participants analysed for specific category. SVR12 is based on Next Value Carried Backwards approach|||Percentage of participants||95% Confidence Interval|Number
2599805|NCT02170727|Secondary|Percentage of Participants With Anemia Defined as Hb < 10 g/dL On-treatment Who Had Hb >=10 g/dL at Baseline|Anemia was defined as hemoglobin < 10 g/dL on-treatment for subjects who had hemoglobin >= 10 g/dL at baseline.|Up to post treatment week 4|Analysis population included enrolled participants who received at least 1 dose of study therapy|||Percentage of Participants||95% Confidence Interval|Number
2599824|NCT02170532|Secondary|Change in 8 Hour Area-under-the-curve FEV1||0 to 8 hours post dose||||percentage of change||Standard Deviation|Mean
2600099|NCT02167074|Secondary|Number of Patients With Adverse Events Per Needle Type|adverse events per needle type, up to 27 months after procedure|27 months after procedure||||Participants|||Count of Participants
2599806|NCT02170727|Secondary|Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment|SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect.|Up to post treatment week 4|Safety analysis population included participants who received at least 1 dose of study therapy.|||Participants|||Count of Participants
2599807|NCT02170727|Secondary|Percentage of Participants Who Achieved HCV RNA < LLOQ TND|Percentage of treated participants with HCV RNA < LLOQ, TND (target not detected) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, at both Weeks 4 and 12, EOT, and follow-up Weeks 4, 8, 12 and 24.|On-treatment Weeks: 1, 2, 4, 6, 8, and 12 and post treatment weeks 4, 8, 12, 24 and EOT (end of treatment)|Included participants who received 1 dose of study therapy. SVR24 based on Observed Values approach. Participants with missing HCV RNA results at follow-up Week 24 were considered non-responders for SVR24. SVR12 is based on Next Value Carried Backwards approach and modified ITT (intent-to-treat) analysis.|||Percentage of Participants||95% Confidence Interval|Number
2599808|NCT02170727|Secondary|Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND|Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, EOT, and follow-up Weeks 4 (SVR4), 8 (SVR8), and 24 (SVR24).|On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8), 24 (SVR24) and EOT (end of treatment)|Included participants who received 1 dose of study therapy. SVR24 based on Observed Values approach. Participants with missing HCV RNA results at follow-up Week 24 were considered non-responders for SVR24. SVR12 is based on Next Value Carried Backwards approach and modified ITT (intent-to-treat) analysis.|||Percentage of Participants||95% Confidence Interval|Number
2599809|NCT02170727|Secondary|Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort|Percentage of treated participants with SVR12 in the IFNα experienced cohort, defined as HCV RNA < LLOQ target detected or target not detected (LLOQ TD/TND).|Post treatment Week 12|Analysis population included enrolled participants who received at least 1 dose of study therapy. SVR12 was based on Next Value Carried Backwards approach.|||Percentage of Participants||95% Confidence Interval|Number
2599810|NCT02170727|Primary|Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort|Percentage of Participants with SVR12 in the naive cohort, defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) (LOQ TD/TND) at post-treatment follow-up Week 12.|Post treatment Week 12|Analysis population included enrolled participants who received at least 1 dose of study therapy. SVR12 was based on Next Value Carried Backwards approach. (Exact binomial confidence interval reported)|||Percentage of Participants||95% Confidence Interval|Number
2599811|NCT02170688|Primary|Difference in Enhancement of the Liver and Blood Vessels Over Time, Measured in Hounsfield Units (HU)|Operator-defined regions-of-interest (ROI) will be obtained from liver parenchyma, the portal vein and the abdominal aorta prior to contrast administration and on each slice through the liver post-contrast. Sum of all three areas reported as Summed measurement.|baseline, post-dose imaging (approximately 1hr)||||Hounsfield units (HU)||Standard Deviation|Mean
2599812|NCT02170688|Secondary|Difference in Volume of Contrast Used, Measured in Milliliters||baseline, post-dose imaging (approximately 1hr)||||Milliliters||Standard Deviation|Mean
2599813|NCT02170662|Secondary|Percent Change in Hair Diameter|The percent change in hair diameter is a recent addition to the methods of assessing efficacy of hair growth promoters. It is a measure of hair mass and does not separate out the effect on terminal and vellus hairs but rather combines the effect on both. Since it is only terminal hairs that contributes to normal hair density, this measure does not add anything to the measures of total, terminal and vellus hair counts in terms of overall effect on hair growth and is therefore not analyzed or reported here.|Baseline to week 17; Week 17 to week 34|Data not analyzed, and therefore not reported.||||||
2599814|NCT02170662|Secondary|Percent Change in the Target Area Vellus Hair Count|Vellus hairs are fine hairs that generally do not grow beyond 1 cm and do not contribute to overall hair density. For the most part, they have a diameter of <40 um. They are increased in number in male pattern baldness|Baseline to week 17; and week 17 to week 34||||Percent change of vellus hair count||Full Range|Mean
2599815|NCT02170662|Secondary|Percent Change in the Target Area Terminal Hair Count|Terminal hairs are those which grow beyond a cm and contribute to overall hair density.|Baseline to week 17; and week 17 to week 34||||percent change of terminal hair count||Full Range|Mean
2599816|NCT02170662|Primary|Percent Change in Target Area Total Hair Count|The primary endpoint is the percent change in total hair count from the beginning and end of each part of the study.|Baseline to week 17; and week 17 to week 34|intention to treat (ITT)|||percentage change in total hair count||Full Range|Mean
2599817|NCT02170649|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC0-oo)|Area under the plasma concentration versus time curve from time zero to infinity (AUC0-oo) of BIA 2-093|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose||||ng.h/mL||Standard Deviation|Mean
2599818|NCT02170649|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification (AUC0-t)|Area under the plasma concentration versus time curve from time zero to the last sampling time at which concentrations were at or above the limit of quantification (AUC0-t) of BIA 2-093|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose||||ng.h/mL||Standard Deviation|Mean
2599819|NCT02170649|Secondary|Time of Occurrence of Cmax (Tmax)|Time of occurrence of Cmax of BIA 2-093|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose||||hours||Full Range|Median
2599820|NCT02170649|Primary|Maximum Observed Plasma Concentration (Cmax)|Maximum observed plasma concentration of BIA 2-093|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose||||ng/mL||Standard Deviation|Mean
2599821|NCT02170532|Secondary|Change in Dyspnea Response as Measured by the University of California, San Diego (UCSD) Dyspnea Scale||Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment|Data for this outcome measure is not reported because the data was not collected.||||||
2599891|NCT02169505|Secondary|Number of Participants With Incidence of Cytomegalovirus (CMV) Reactivation and/or CMV Disease.|Evaluate the CMV in blood|an average of 12 months||||Participants|||Count of Participants
2599825|NCT02170532|Primary|Change in Maximum Forced Expiratory Volume at One Second (FEV1)||Baseline (before treatment), 30 minutes, 1, 2, 4, 6, and 8 hours post treatment|The same 10 subjects received each of the 5 treatments in the same order. Subjects 1-5 were not included in 6 and 8 hour time points.|||percentage of change||Standard Deviation|Mean
2599826|NCT02170519|Secondary|Change in Mean Venous Oxygen Saturation (SvO2) From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects|||percent change||Standard Deviation|Mean
2599827|NCT02170519|Secondary|Change in Mean Venous Oxygen Saturation (SvO2) From Baseline|SvO2 represents an average of all the venous oxygen saturations of the various organs and tissues.|30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects: 4 subjects did not have a swan ganz catheter. 1 subject had a swan ganz catheter, but measurement was unattainable.|||percent change||Standard Deviation|Mean
2599828|NCT02170519|Primary|Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects|||percent change||Standard Deviation|Mean
2599829|NCT02170519|Primary|Change in Mean Pulmonary Artery Pressure (mPAP) From Baseline||30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects: Measurement completed on subjects having a Swan Ganz catheter. 4 subjects did not have a swan ganz catheter.|||percent change||Standard Deviation|Mean
2599830|NCT02170519|Primary|Number of Treatment Failures|"Treatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following:~Cardiac Index (CI) >/= 1.8 L/min/m2~Administration of >/=0.1 ug/kg/min Epinephrine or Norepinephrine~MAP </= 50 mmHg (or as appropriate for age in pediatrics).~SvO2</= 55% (or < 45% for patients with R to L intracardiac shunting and, thus, cyanosis at baseline.}"|as long as subject was on drug up to approximately 24 hours||||participants|||Number
2599831|NCT02170519|Secondary|Change in Cardiac Output (CO) From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects|||percent change||Standard Deviation|Mean
2599832|NCT02170519|Secondary|Change in Cardiac Output (CO) From Baseline||30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects: 4 subjects did not have a swan ganz catheter. 1 subject had a swan ganz catheter, but measurement was unattainable.|||percent change||Standard Deviation|Mean
2599833|NCT02170519|Primary|Change in Mean Heart Rate From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects|||percent change||Standard Deviation|Mean
2599834|NCT02170519|Primary|Change in Mean Heart Rate From Baseline||30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects|||percent change||Standard Deviation|Mean
2599835|NCT02170519|Primary|Percent Change in Oxygen Saturation (SpO2) From Baseline||dose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)|Phase 1 subjects|||percent change||Standard Deviation|Mean
2599836|NCT02170519|Primary|Percent Change in Oxygen Saturation (SpO2) From Baseline|Readings were taken from the medical record and the data may not have been present at the exact time frames.|30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours|Phase 2 subjects|||percent change||Standard Deviation|Mean
2599837|NCT02170389|Secondary|Adverse Event Rates as Graded by the Common Terminology Criteria for Adverse Events Version 4.0|Summarized in all patients who received AGS-003. These rates will be described as the proportion of patients with the event, by grade, and supported with exact 95% confidence intervals.|Up to 30 days|Only patients who received any injections were included.|||percentage of subjects||95% Confidence Interval|Number
2599838|NCT02170389|Primary|Change in Immune Marker Expression Levels|"The time component will be modeled as a three-level classification factor. The full model for the effects of time will be fit using linear mixed model methods. The model will include a random patient effect and 5 fixed effects for time and the interactions. The presence of any time effect will be assessed with full-reduced model type 3 test. If the omnibus test is statistically significant at the p < 0.05 level, then three pairwise time-point comparisons will be conducted.~Expression measurements may be transformed to satisfy modeling assumptions."|Baseline to up to 30 days post-nephrectomy|The clinical trial was terminated due to lack of funding before data were collected.||||||
2599839|NCT02170376|Primary|t1/2 - Terminal Plasma Half-life|t1/2 - Terminal plasma half-life of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration||||Hours||Standard Deviation|Mean
2599840|NCT02170376|Primary|AUC0-5 - AUC Over 5 Hours|AUC0-5 - of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration||||ng.h/mL||Standard Deviation|Mean
2599841|NCT02170376|Primary|AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Time (t) Corresponding to the Last Quantifiable Concentration.|AUC0-t - of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration||||ng.h/mL||Standard Deviation|Mean
2599842|NCT02170376|Primary|AUC0-∞ - Area Under the Concentration-time Curve From Time Zero up to Infinity With Extrapolation of the Terminal Phase|AUC0-∞ of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration||||ng.h/mL||Standard Deviation|Mean
2599843|NCT02170376|Primary|Tmax - Time of Occurrence of Maximum Plasma Concentration|Tmax - Time to Reach maximum plasma concentration of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration||||hours||Standard Deviation|Mean
2599844|NCT02170376|Primary|Cmax - Maximum Plasma Concentration of Levodopa|Cmax - Maximum plasma concentration of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.|pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration||||ng/mL||Standard Deviation|Mean
2599845|NCT02170363|Secondary|Stroke Free Survival|Percentage of participants free of debilitating stroke (Modified Rankin Score > 3)|6 months||||percentage of participants|||Number
2599846|NCT02170363|Secondary|Rehospitalizations|Frequency and incidence of rehospitalizations|As they occurred, Baseline through 180 Days|Number of Participants with Rehospitalizations According to Rehospitalization Type|||Participants|||Count of Participants
2599847|NCT02170363|Secondary|Reoperations|Frequency of reoperations|As they occurred, Baseline through 180 Days|Twenty-nine (58%) did not have reoperation|||Number of re-operations by reason|||Number
2599848|NCT02170363|Secondary|Device Malfunctions|Frequency and incidence of device malfunction|As they occurred, Baseline through 180 Days; Subjects that remain ongoing after 6 months will continue to be followed to 24 months post-implant or outcome||||Number of events|||Number
2599849|NCT02170363|Secondary|All Adverse Events|Frequency of pre-defined anticipated adverse events|As they occurred, Baseline through 180 Days||||% of Participants with Adverse Events|||Number
2599850|NCT02170363|Secondary|Functional Status - New York Heart Association (NYHA) Classification|NYHA classification relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort|Baseline, Month 1, Month 3, Month 6|Only patients alive, capable and willing to perform test are included.|||percentage of participants|||Number
2599851|NCT02170363|Secondary|Functional Status - Six Minute Walk Test (6MWT)|The Six Minute Walk Test(6MWT)measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.|Baseline, Month 1, Month 3, Month 6|Only patients alive, capable and willing to perform test are included.|||meters||Full Range|Median
2599852|NCT02170363|Secondary|Quality of Life (EQ-5D-5L)|The EQ-5D-5L is a standardized measure of health status developed by the EuroQol Group. Patients describe their perceived health status using an analog scale with 0 as the worst health the patient can imagine and 100 as the best health (Visual Analog Score). The patients' scores at one, three and six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life.|Baseline, Month 1, Month 3, Month 6|Patients alive and capable of performing the test at 6 months|||Units on a EQ-5D-5L Score scale||Full Range|Median
2599853|NCT02170363|Primary|Survival|Comparison of survival at 6 months of Left Ventricular Assist Device (LVAD) support to a performance goal established using matched HeartMate II INTERMACS data|6 months|All 50 patients were analyzed when the last patient reached the 6-month primary endpoint on May 26, 2015|||Percentage of Participants who Survived||97.5% Confidence Interval|Number
2599854|NCT02170298|Primary|Delay Discounting|Level of self-control, as demonstrated on the Delay Discounting Task.|Baseline, 9 weeks|Data were not analyzed due to early study termination. Unable to recruit a sufficient number of subjects. Data on this measure is highly variable and low subject numbers will not produce reliable or valid data.||||||
2599855|NCT02170298|Primary|Working Memory|Working memory performance, as measured by the percent of items correct on the Span Working Memory Task.|Baseline, 9 weeks|Data were not analyzed due to early study termination. Unable to recruit a sufficient number of subjects. Data on this measure is highly variable and low subject numbers will not produce reliable or valid data.||||||
2599856|NCT02170220|Primary|Cmaxu: Maximum Observed Unbound Plasma Concentration for Vortioxetine|Maximum Observed Unbound Plasma Concentration (Cmaxu) is the peak unbound plasma concentration of a drug after administration, obtained directly from the unbound plasma concentration-time curve.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng/mL||Standard Deviation|Mean
2599857|NCT02170220|Primary|AUC(0-inf)u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine|AUC(0-inf)u is a measure of total unbound plasma exposure to the drug from time zero extrapolated to infinity.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2599858|NCT02170220|Primary|AUC(0-tlqc)u: Area Under the Unbound Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine|AUC(0-tlqc)u is a measure of total unbound plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]u).|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2599859|NCT02170220|Primary|Cmax: Maximum Observed Plasma Concentration for Vortioxetine Metabolite Lu AA39835|Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng/mL||Standard Deviation|Mean
2599860|NCT02170220|Primary|Cmax: Maximum Observed Plasma Concentration for Vortioxetine Metabolite Lu AA34443|Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng/mL||Standard Deviation|Mean
2599861|NCT02170220|Primary|Cmax: Maximum Observed Plasma Concentration for Vortioxetine|Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng/mL||Standard Deviation|Mean
2599862|NCT02170220|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine Metabolite Lu AA34443|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2599863|NCT02170220|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2599864|NCT02170220|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine Metabolite Lu AA39835|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]).|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2599865|NCT02170220|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine Metabolite Lu AA34443|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]).|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|PK Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2599866|NCT02170220|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]).|Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose|Pharmacokinetic (PK) Analysis Set included all enrolled participants who received at least 1 dose of study drug with at least 1 measureable plasma concentration.|||ng*hr/mL||Standard Deviation|Mean
2599867|NCT02170207|Secondary|Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment|Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.|Week 17 (8 weeks after the last dose of study drug)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
2599868|NCT02170207|Secondary|Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding During Treatment|Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy during treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
2599869|NCT02170207|Secondary|Percentage of Participants With Confirmed Hemostatic Effect|Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with confirmed hemostatic effect by endoscopy. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with confirmed hemostatic effect.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
2599870|NCT02170207|Secondary|Percentage of Participants With Observed Hemostatic Effect|Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with observed hemostatic effect. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with observed hemostatic effect.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
2599892|NCT02169505|Secondary|Number of Participants With Relapse|Evaluate the safety of brentuximab early after allogeneic stem cell transplant and haploidentical allogeneic transplantant and observe if there is a decrease in the risk of relapse.|an average of 12 months||||Participants|||Count of Participants
2599871|NCT02170207|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to Week 9|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
2599872|NCT02170077|Primary|"The Percentage of Participants With a 50% or Greater Reduction in Seizure Frequency (Further Referred to as Responders) in a Treatment Period Compared to the Baseline Period"||baseline, week 12||||percentage of responders|||Number
2599873|NCT02170064|Secondary|Percentage Change in Seizure Frequency During Each 4-week Treatment Period Compared to the Baseline Phase|"The efficacy variables were the percentage change in seizure frequency during each 4-week treatment period compared to the baseline phase.~Seizures were recorded in the patient's diary during the baseline phase and during the following 4-week treatment periods.~Seizure frequency for each patient was standardised to a frequency per 28 days period (i.e., mean daily frequency multiplied by 28). Changes in seizure frequency were analysed for each age group separately."|Baseline, end of 5 mg/kg/day treatment period (4 weeks), 15 mg/kg/day treatment period (4 weeks) and 30 mg/kg/day treatment period (4 weeks).||||percent change||95% Confidence Interval|Median
2599874|NCT02170064|Primary|Time of Occurrence of Cmax (Tmax).||pre-dose, and ½, 1½, 3, 4½, 6 and 12 hours post-dose||||hours||Standard Deviation|Mean
2599875|NCT02170064|Primary|Maximum Observed Plasma Drug Concentration (Cmax) Post-dose||pre-dose, and ½, 1½, 3, 4½, 6 and 12 hours post-dose||||ng/mL||Standard Deviation|Mean
2599876|NCT02170025|Secondary|Change of FEV1 From Baseline|Spirometry was performed according to the American Thoracic Society Guidelines 1995 at the time points screening/ baseline, treatment period and follow up.|From Baseline to Day 14, Day 28 and Follow-up|Pharmacodynamic analysis set (N=16) included patients who received the medication and who had valid sweat chloride data for efficacy analysis.|||% predicted value||Standard Deviation|Mean
2599877|NCT02170025|Primary|Change of Sweat Chloride Content From Baseline|Sweat chloride samples were obtained by using a Macroduct induction and collection device according to standard procedures.|Baseline, at day 14 and day 28 in study part 1|Pharmacodynamic analysis set (N=16) included patients who received the medication and who had valid sweat chloride data for efficacy analysis.|||mmol/L||Standard Deviation|Mean
2599878|NCT02169895|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve|AUC0-t - area under the plasma concentration-time curve of benserazide.|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.||||ng.h/mL||Standard Deviation|Mean
2599879|NCT02169895|Primary|Tmax - Time of Occurrence of Cmax|tmax - time of occurrence of Cmax of benserazide|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||hours||Full Range|Median
2599880|NCT02169895|Primary|Maximum Observed Plasma Drug Concentration (Cmax)|Cmax - Maximum observed plasma drug concentration of benserazide|pre-dose, 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||ng/mL||Standard Deviation|Mean
2599881|NCT02169869|Primary|Proportion of Subjects With an IUD at 3 Months Postpartum|Subjects were contacted at 3 months after delivery. Comparison of the proportion of women randomized to placement of IUD within 60 minutes of placental delivery or at their 6-week routine postpartum visit who report having an IUD in place at 3 months after delivery.|3 months postpartum (after delivery)||||Participants|||Count of Participants
2599882|NCT02169674|Other Pre-specified|HBs Antigenemia|The number of baseline serum samples that contain HBs antigen, as a function of time since immunization.|Baseline||||Participants|||Count of Participants
2599883|NCT02169674|Other Pre-specified|Anti-HBc (Hepatitis B Core Antigen) Antibody|The number of baseline serum samples that contain anti-HBc antibodies, as a function of time since immunization|Baseline sample||||Participants|||Count of Participants
2599884|NCT02169674|Other Pre-specified|Geometric Mean Concentration of Anti-HBs|The geometric mean concentration of anti-HBs antibodies before and after booster vaccination, in both age groups|Before and after booster immunization|Post challenge number analyzed are those nonseroprotected at baseline minus two withdrawals in the 10-11 year-old group and one withdrawal and one loss to follow-up in the 15-16 year-old group.|||mIU/ml||95% Confidence Interval|Geometric Mean
2599885|NCT02169674|Primary|Recollection of Anti-HBs Titer >12 IU/L After Booster|The primary outcome measure is the number of participants who have capacity to recall anti-HBs titer >12 IU/L after HB booster vaccination.|28 days after HB booster||||Participants|||Count of Participants
2599886|NCT02169674|Primary|Serum Anti-HBs Concentration 12 IU/L or Greater|The primary outcome measure is the number of participants who have residual HB immunity 10 or 15 years after infant HB immunization, defined by a persistent anti-HBs titer >12 IU/L.|10 or more years after infant HB immunization||||Participants|||Count of Participants
2599887|NCT02169505|Secondary|Number of Participants With Progression-Free Survival and Overall Survival on Brentuximab Maintenance|The Kaplan-Meier (1958) survival curves were used to estimate the overall survival and progression-free survival. Cox proportional hazards regression analysis was used to model the association between overall survival and progression-free survival and disease and demographic covariates of interest.|an average of 12 months|Participant one had a progression free survival and overall survival.|||Participants|||Count of Participants
2599888|NCT02169505|Secondary|Number of Participants With Change in Serum CD30 Levels After Brentuximab Administration|Immunological correlative studies on peripheral blood mononuclear cells (PBMC) and serum will be collected from participants at baseline (prior to initiation of brentuximab therapy) and on days 1, 3, and 5 after initiation of brentuximab and every 21 days thereafter to assess the effect on T cell subsets and their effector function as well as CD30 levels.|an average of 12 months||||Participants|||Count of Participants
2599889|NCT02169505|Secondary|Number of Participants With Central and Effector Cell Effects|We will perform on peripheral blood for mononuclear cells (PBMC) and serum collected from participants at baseline (prior to initiation of brentuximab therapy) and on days 1, 3, and 5 after initiation of brentuximab and every 21 days thereafter to assess the effect on T cell subsets and their effector function as well as other immune subsets.|an average of 12 months||||Participants|||Count of Participants
2599890|NCT02169505|Secondary|Number of Participants With Acute Graft-versus-host Disease (GVHD).|The tissue and serum in participants were measured by the GVHD|an average of 12 months||||Participants|||Count of Participants
2599894|NCT02169505|Primary|Number of Participants With Secondary Graft Failure|Safety is defined by no more than two secondary graft failures within 6 months of transplant (Day 0), based on an observed graft failure rate of <10% using standard of care treatment. If at any time more than two of these events are observed during the specified time frame, the study will be stopped and no further patients will be accrued.|An average of 12 months||||participants|||Number
2599895|NCT02169479|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve|Area under the plasma concentration-time curve for levodopa|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||ng.h/mL||Standard Deviation|Mean
2599896|NCT02169479|Primary|Tmax - Time of Occurrence of Cmax of Levodopa|Tmax - time of occurrence of Cmax of levodopa.|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||hours||Full Range|Median
2599897|NCT02169479|Primary|Cmax - Maximum Observed Plasma Concentration of Levodopa|Levodopa maximum observed plasma concentration (Cmax) (ng/mL)|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||ng/mL||Standard Deviation|Mean
2599898|NCT02169466|Primary|Tmax - Time to Cmax|Primary pharmacokinetic parameter: tmax - time to Cmax|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods.|||hours||Full Range|Mean
2599899|NCT02169466|Primary|AUC0-∞ - AUC From Time Zero to Infinity|Primary pharmacokinetic parameter: Area under the plasma concentration-time curve from time zero to infinity for levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods.|||ng.h/mL||Standard Deviation|Mean
2599900|NCT02169466|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve|Primary pharmacokinetic parameter: Area under the plasma concentration-time curve for levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods.|||ng.h/mL||Standard Deviation|Mean
2599901|NCT02169466|Primary|Cmax - Maximum Observed Plasma Concentration of Levodopa|Primary pharmacokinetic parameter: Levodopa maximum observed plasma concentration (Cmax) (ng/mL)|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods.|||ng/mL||Standard Deviation|Mean
2599902|NCT02169453|Primary|AUEC0-24 - Area Under the Effect-time Curve From t=0h to t=24h||pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||pmol/mg Hb/h.h||Standard Deviation|Mean
2599903|NCT02169453|Primary|tEmax - Time of Occurrence of Emax||pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||hours||Standard Deviation|Mean
2599904|NCT02169453|Primary|Emax - Maximum Inhibition of COMT Activity|Emax - Maximum inhibition of Catechol-O-Methyltransferase (COMT) activity|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||pmol/mg Hb/h||Standard Deviation|Mean
2599905|NCT02169453|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity|AUC0-∞ - Area under the plasma concentration-time curve extrapolated to infinity for levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||ng.h/mL||Standard Deviation|Mean
2599906|NCT02169453|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point|AUC0-t - Area under the plasma concentration-time curve to last measurable time point for levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||ng.h/mL||Standard Deviation|Mean
2599907|NCT02169453|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax - Maximum observed plasma concentration of levodopa|pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose||||ng/mL||Standard Deviation|Mean
2599908|NCT02169440|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration (Warfarin + BIA 9-1067)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.||||ng.h/mL||Standard Deviation|Mean
2599909|NCT02169440|Primary|Tmax - Time to Maximum Observed Plasma Concentration (Warfarin + BIA 9-1067)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.||||hours||Full Range|Median
2599910|NCT02169440|Primary|Cmax - Maximum Observed Plasma Concentration (Warfarin + BIA 9-1067)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.||||ng/mL||Standard Deviation|Mean
2599911|NCT02169440|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration (Warfarin Alone)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral singledose of 25 mg warfarin administered alone|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.||||ng.h/mL||Standard Deviation|Mean
2599912|NCT02169440|Primary|Tmax - Time to Maximum Observed Plasma Concentration (Warfarin Alone)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral singledose of 25 mg warfarin administered alone|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.||||hours||Full Range|Median
2599913|NCT02169440|Primary|Cmax = Maximum Plasma Concentration (Warfarin Alone)|Mean plasma S-warfarin pharmacokinetic parameters obtained following an oral singledose of 25 mg warfarin administered alone|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.||||ng/mL||Standard Deviation|Mean
2599914|NCT02169440|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration (BIA 9-1067 + Warfarin)|Mean plasma BIA 9-1067 pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.||||ng.h/mL||Standard Deviation|Mean
2599939|NCT02169115|Secondary|To Assess the Effects of Omalizumab in UF Patients on Patient Global Assessment of Disease Severity|Change in patient global assessment of disease severity assessed by visual analogue scale by the patient from baseline to day 70 after treatment with omalizumab compared to placebo.|70 days|||||||
2599915|NCT02169440|Primary|Tmax - Time to Maximum Observed Plasma Concentration (BIA 9-1067 + Warfarin)|Mean plasma BIA 9-1067 pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.||||hours||Full Range|Median
2599916|NCT02169440|Primary|Cmax - Maximum Observed Plasma Concentration (BIA 9-1067 + Warfarin)|Mean plasma BIA 9-1067 pharmacokinetic parameters obtained following an oral single dose of 25 mg warfarin co-administered with 25 mg BIA 9-1067|before dose and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post- dose.||||ng/mL||Standard Deviation|Mean
2599917|NCT02169427|Secondary|Tmax - Time to Attain Maximum Concentration|BIA 9-1103 is a Opicapone (OPC, BIA 9-1067) metabolite|pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29||||hours||Standard Deviation|Mean
2599918|NCT02169427|Secondary|Cmax - Maximum Concentration|BIA 9-1103 is a Opicapone (OPC, BIA 9-1067) metabolite|pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29||||ng [eq]/mL||Standard Deviation|Mean
2599919|NCT02169427|Primary|Cumulative Recovery of [14C]-Radioactivity|"AEurine: Cumulative Recovery of [14C]-Radioactivity in urine AEfaeces: Cumulative Recovery of [14C]-Radioactivity in urine AEair: Cumulative Recovery of [14C]-Radioactivity in urine AEtotal: Cumulative Recovery of [14C]-Radioactivity in urine~Recovery % of dose has been derived from area under the excretion rate (to infinity) from 240h onwards"|pre-dose and 0-6, 6-12, 12-24, 24-48, 48 72, 72-96, 96 120, 120-144, 144-168, 168-192, 192-216 and 216-240 hours post-dose; 24-hour collections on Days 14/15, 21/22, 28/29||||Recovery % of dose||Standard Deviation|Mean
2599920|NCT02169414|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification. (Levodopa/Benserazide)|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose||||ng.h/mL||Standard Deviation|Mean
2599921|NCT02169414|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity (Levodopa/Benserazide)|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.||||ng.h/mL||Standard Deviation|Mean
2599922|NCT02169414|Primary|Tmax - Time to Reach Maximum Plasma Concentration of Levodopa (Levodopa/Benserazide)|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.||||hours||Standard Deviation|Mean
2599923|NCT02169414|Primary|Cmax - Maximum Plasma Concentration of Levodopa (Levodopa/Benserazide )|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.||||ng/mL||Standard Deviation|Mean
2599924|NCT02169414|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification. (Levodopa/Carbidopa)|AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.||||ng.h/mL||Standard Deviation|Mean
2599925|NCT02169414|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity (Levodopa/Carbidopa)|Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.||||ng.h/mL||Standard Deviation|Mean
2599926|NCT02169414|Primary|Tmax - Time to Reach Maximum Plasma Concentration of Levodopa (Levodopa/Carbidopa)|Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.||||hours||Standard Deviation|Median
2599927|NCT02169414|Primary|Cmax - Maximum Plasma Concentration of Levodopa (Levodopa/Carbidopa)|Cmax - Maximum plasma concentration of levodopa following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.||||ng/mL||Standard Deviation|Mean
2599928|NCT02169336|Primary|Summed Pain Intensity Difference Over the First 48 Hours (SPID48).|Pain intensity was recorded using a Numeric Rating Scale (Range 0-10) where 0 equates to no pain, and 10 equates to the worst pain imaginable. Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours. Pain intensity differences from baseline at each time point were calculated and a time weighted SPID was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation.|48 hours||||units on a scale||Standard Deviation|Mean
2599929|NCT02169219|Secondary|Vasculitis Damage Index (VDI)|The Vasculitis Damage Index (VDI) is a single-page catalog of damage items separated into 11 groupings of items by organ system. There are a total of 60 items. Each item is recorded if it occurred since the onset of vasculitis, has been present for at least 3 months, or occurred at least 3 months ago. Each item of damage is scored as present (1) or absent (0), yielding a maximum score of 60.|24 months||||units on a scale||Inter-Quartile Range|Mean
2599940|NCT02169115|Secondary|To Assess the Effects of Omalizumab in UF Patients on Physician Global Assessment of Disease Severity|Change in physician global assessment of disease severity assessed by visual analogue scale by a physician from baseline to day 70 after treatment with omalizumab compared to placebo.|70 days|||||||
2599941|NCT02169115|Secondary|To Assess the Effects of Omalizumab in UF Patients on Number of Symptom Free Days|Change in number of symptom free days as assessed by a patient diary from baseline to day 70 after treatment with omalizumab compared to placebo|70 days|||||||
2599942|NCT02169115|Secondary|To Assess the Effects of Omalizumab in Urticaria Factitia Patients on Quality of Life|Change in quality of life scores assessed by Dermatology Life Quality Index (DLQI) and UF specific life quality questions from baseline to day 70 after treatment with omalizumab compared to placebo.|70 days|||||||
2599943|NCT02169115|Primary|Change in Provocation Thresholds From Baseline to Day 70 in Urticaria Factitia Patients After Treatment With Omalizumab Compared to Placebo|Patients receive provocation test by FricTest (standardized stroking of the skin). FricTest ratings are from 0 (no wheal development to the longest pin) to 4 (wheal development to all four pins). The development of wheals within 30 minutes after provocation is monitored.|70 days||||wheal development up to four pins||Standard Deviation|Mean
2599944|NCT02168946|Secondary|Proportion of Subjects in the m-MITT Populations With a With a Response of Overall Success (Bacteremia Only)|Proportion of subjects in m-MITT Population with response of cure and microbiological eradication or presumed eradication. Clinical cure defined as complete resolution or significant improvement of the baseline signs & symptoms, no further antimicrobial warranted.|at EOT visit (7-14) and TOC visit (day 12-23)|m-MITT Population (Bacteremia Subjects Only)|||Participants|||Count of Participants
2599945|NCT02168946|Secondary|Proportion of Subjects in the m-MITT Populations With a With a Response of Overall Success (cUTI/AP)|Proportion of subjects in m-MITT Population with response of cure and microbiological eradication or presumed eradication. Eradication defined for cUTI/AP as the demonstration that the bacterial pathogen(s) found at baseline is reduced to <10x4 CFU/mL urine (FDA). Clinical cure defined as complete resolution or significant improvement of the baseline signs & symptoms, no further antimicrobial warranted.|at EOT visit (7-14) and TOC visit (day 12-23)|m-MITT Population (cUTI/AP Subjects Only)|||Participants|||Count of Participants
2599946|NCT02168946|Secondary|Proportion of Subjects in the m-MITT Population With a Microbiological Outcome of Eradication (All Indications)|Microbiological eradication defined for cUTI/AP as the demonstration that the bacterial pathogen(s) found at baseline is reduced to <10x4 CFU/mL urine (FDA).|at EOT visit (7-14) and TOC visit (day 12-23)|m-MITT Population (all indications)|||Participants|||Count of Participants
2599947|NCT02168946|Secondary|Proportion of Subjects in the mCRE-MITT Population With a Microbiological Outcome of Eradication (All Indications)|Includes subjects with microbiologic eradication or presumed eradication as defined: microbiologic eradication of the baseline pathogen or absence of culture result (microbiologic outcome of indeterminate or not assesses) where subject is deemed as clinical cure at that visit. For cUTI/AP subjects, demonstration that the bacterial pathogen(s) found at baseline is reduced to <10x4 CFU/mL urine (FDA).|at EOT visit (7-14) and TOC visit (day 12-23)|mCRE-MITT Population (all indications)|||Participants|||Count of Participants
2599948|NCT02168946|Secondary|Proportion of Subjects in the m-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia)|Clinical cure defined as complete resolution or significant improvement of the baseline signs & symptoms, no further antimicrobial warranted.|at EOT visit (7-14) and TOC visit (day 12-23)|m-MITT Population (HABP/VABP or Bacteremia Subjects only)|||Participants|||Count of Participants
2599949|NCT02168946|Secondary|Proportion of Subjects in the m-MITT Population With a Clinical Outcome of Cure (cUTI/AP)|Clinical cure defined as complete resolution or significant improvement of the baseline signs & symptoms, no further antimicrobial warranted.|at EOT visit (7-14) and TOC visit (day 12-23)|m-MITT Population (cUTI/AP subjects only)|||Participants|||Count of Participants
2599950|NCT02168946|Secondary|Proportion of Subjects in the Microbiological Modified Intent-to-Treat (m-MITT) Population With a Clinical Outcome of Cure (All Indications)|Clinical cure defined as complete resolution or significant improvement of the baseline signs and symptoms, no further antimicrobial warranted.|at EOT visit (7-14) and TOC visit (day 12-23)|m-MITT Population (all indications)|||Participants|||Count of Participants
2599951|NCT02168946|Secondary|Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia)|Clinical cure defined as complete resolution or significant improvement of the baseline signs & symptoms, no further antimicrobial warranted.|at EOT visit (7-14) and TOC visit (day 12-23)|mCRE-MITT (HABP/VABP or Bacteremia Subjects only)|||Participants|||Count of Participants
2599952|NCT02168946|Secondary|Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (cUTI/AP Subjects Only)|Clinical cure defined as complete resolution or significant improvement of the baseline signs & symptoms, no further antimicrobial warranted.|at EOT visit (7-14) and TOC visit (day 12-23)|mCRE-MITT population (cUTI/AP subjects only)|||Participants|||Count of Participants
2599953|NCT02168946|Secondary|Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (All Indications)|Clinical cure defined as complete resolution or significant improvement of the baseline signs & symptoms, no further antimicrobial warranted.|at End of Therapy (EOT) visit (7-14 days) and TOC visit (12-23 days)|mCRE-MITT population (all indications)|||Participants|||Count of Participants
2599954|NCT02168946|Secondary|The All-cause Mortality Rate in the mCRE-MITT Population (cUTI/AP)|All Cause Mortality at Day 28 in the mCRE-MITT population (cUTI/AP subjects only)|at Day 28|mCRE-MITT (cUTI/AP subjects only)|||Participants|||Count of Participants
2599955|NCT02168946|Secondary|The All-cause Mortality Rate in the m-MITT Population (All Indications)|The All Cause Mortality rate at Day 28 in the m-MITT population (all indications)|at Day 28|The m-MITT population includes all patients who receive at least one dose of study drug and have a baseline gram negative bacterial pathogen.|||Participants|||Count of Participants
2599956|NCT02168946|Secondary|The All-cause Mortality Rate in the mCRE-MITT Population (All Indications)|All Cause Mortality at Day 28 in the mCRE-MITT population (all indications)|at Day 28|mCRE-MITT population (all indications)|||Participants|||Count of Participants
2599971|NCT02168842|Secondary|Risk of Need for Antiparkinsonian Therapy|Number of participants with need for Antiparkinsonian Therapy.|Baseline to 36 months of treatment|Include all 336 patients that were randomized, no matter whether or not completed the study.|||participants||95% Confidence Interval|Number
2599957|NCT02168946|Primary|Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure [Complicated Intra-abdominal Infection (cIAI) Subjects Only]|Clinical cure defined as complete resolution or significant improvement of the baseline signs and symptoms, no further antimicrobial warranted.|at TOC visit (Day 12-23)||||Participants|||Count of Participants
2599958|NCT02168946|Primary|All-cause Mortality Rate in the mCRE-MITT Population [Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bacteremia Subjects)|The All-cause mortality rate at Day 28 in the mCRE-MITT population (HABP/VABP and Bacteremia)|Day 28|mCRE-MITT Population (HABP/VABP and Bacteremia subjects only)|||Participants|||Count of Participants
2599959|NCT02168946|Primary|Proportion of Subjects in the Microbiological Carbapenem-resistant Enterobacteriaceae Modified Intent-to-Treat (mCRE-MITT) Population With a Response of Overall Success [Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) Subjects]|Overall success is defined as clinical cure & microbiological eradication. Eradication defined by FDA as the demonstration that the bacterial pathogen(s) found at baseline is reduced to <10x4 colony forming unit (CFU)/mL urine. Clinical cure defined as complete resolution or significant improvement of the baseline signs & symptoms, no further antimicrobial warranted.|at Test of Cure (TOC) visit (Day 12-23)|The mCRE-MITT population includes all patients who had confirmed Carbapenem-Resistant Enterobacteriaceae at Baseline. (cUTI/AP patients only)|||Participants|||Count of Participants
2599960|NCT02168933|Secondary|Patient Assessment of Nail Psoriasis Activity|this is a subjective patient reported scale, 0-100, where 100 is the most severe global assessment of the patient's nail psoriasis, and 0 is clear (no nail disease present).|at 16 weeks||||units on a scale||Standard Deviation|Mean
2599961|NCT02168933|Primary|Modified NAPSI Score (Nail Psoriasis Severity Index)|This is an instrument that scores nail psoriasis severity. Severity for each nail is measured on a scale of 0-13, where crumbling, pitting, onycholysis and oil spots together are each graded 0-3, and other features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in lunula) are scored 0 (absent) or 1 (present). Higher score indicates more severe nail psoriasis with 13 being the most severe and 0 being no nail disease present.|at 16 weeks||||units on a scale||Standard Deviation|Mean
2599962|NCT02168842|Other Pre-specified|Adjusted Mean Change in Diastolic BP, Seated|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Diastolic BP, Seated in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Diastolic BP, Seated ranges from -35 to 25. larger value shows worsening of conditions.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline Diastolic BP, Seated. So Diastolic BP had 1 observation more than primary outcomes.|||mmHg||95% Confidence Interval|Least Squares Mean
2599963|NCT02168842|Other Pre-specified|Adjusted Mean Change in Systolic BP, Seated|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Systolic BP, Seated in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Systolic BP, Seated ranges from -65 to 50. larger value shows worsening of conditions.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline Systolic BP, Seated. So Systolic BP had 1 observation more than primary outcomes.|||mmHg||95% Confidence Interval|Least Squares Mean
2599964|NCT02168842|Other Pre-specified|Adjusted Mean Change in Levodopa Cumulative|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Levodopa Cumulative in the active treatment arm versus placebo between the baseline and 36 month visit. The change of Levodopa cumulative ranges from 0 to 800000, larger value shows more disability from PD.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline Levodopa Cumulative. So Levodopa Cumulative had 1 observation more than primary outcomes.|||mg||95% Confidence Interval|Least Squares Mean
2599965|NCT02168842|Other Pre-specified|Adjusted Mean Change in Levodopa|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Levodopa in the active treatment arm versus placebo between the baseline and 36 month visit. The change of LED ranges from -200 to 2000, larger value shows more disability from PD.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline Levodopa. So Levodopa had 1 observation more than primary outcomes.|||mg||95% Confidence Interval|Least Squares Mean
2599966|NCT02168842|Other Pre-specified|Adjusted Mean Change in H/Y Stage|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the H/Y Stage in the active treatment arm versus placebo between the baseline and 36 month visit. The change in H/Y Stage ranges from -1 to 3, larger value shows worsening of conditions.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline H/Y Stage. So H/Y Stage had 1 observation more than primary outcomes.|||units on a scale||95% Confidence Interval|Least Squares Mean
2599967|NCT02168842|Other Pre-specified|Adjusted Mean Change in UPDRS Tremor Score|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Tremor Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Tremor Score ranges from -1 to 2, larger value shows worsening of conditions.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population|||units on a scale||95% Confidence Interval|Least Squares Mean
2599968|NCT02168842|Other Pre-specified|Adjusted Mean Change in UPDRS PIGD Score|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS PIGD Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS PIGD Score ranges from -1 to 3, larger value shows worsening of conditions.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population|||units on a scale||95% Confidence Interval|Least Squares Mean
2599969|NCT02168842|Secondary|Risk of Need for Fluctuations|Number of participants with need for Fluctuations Therapy.|Baseline to 36 months of treatment|Include all 336 patients that were randomized, no matter whether or not completed the study.|||participants||95% Confidence Interval|Number
2599970|NCT02168842|Secondary|Risk of Need for Dyskinesia|Number of participants with need for Dyskinesia Therapy.|Baseline to 36 months of treatment|Include all 336 patients that were randomized, no matter whether or not completed the study.|||participants||95% Confidence Interval|Number
2599972|NCT02168842|Secondary|Adjusted Mean Change in BDI Total Score|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the BDI Total Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in BDI Total Score ranges from -9 to 22, larger value shows worsening of conditions.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population. One participant in Placebo group had missing baseline UPDRS sections while had finished baseline BDI Score. And one participant in Isradipine group had missing BDI score at the visit of 36 months.|||units on a scale||95% Confidence Interval|Least Squares Mean
2599973|NCT02168842|Secondary|Adjusted Mean Change in Ambulatory Capacity|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Ambulatory Capacity in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Ambulatory Capacity ranges from -4 to 12, larger value shows worsening of conditions.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population|||score on a scale||95% Confidence Interval|Least Squares Mean
2599974|NCT02168842|Secondary|Adjusted Mean Change in PDQ39 Total Score|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the PDQ39 Total Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in PDQ39 Total Score ranges from -16 to 44, larger value shows worsening of conditions.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population. 7 patients had missing PDQ39 scores at the visit of 36 months.|||units on a scale||95% Confidence Interval|Least Squares Mean
2599975|NCT02168842|Secondary|Adjusted Mean Change in MoCA Score|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MoCA Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in MoCA Score ranges from -10 to 6, larger value shows improvement of conditions.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline MoCA Score. So MoCA Score had 1 observation more than primary outcomes.|||units on a scale||95% Confidence Interval|Least Squares Mean
2599976|NCT02168842|Secondary|Adjusted Mean Change in Modified Rankin Score|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the Modified Rankin Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change in Modified Rankin Score ranges from -1 to 3, larger value shows worsening of conditions.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population. One participant had missing baseline measurement for primary efficacy while had finished baseline Modified Rankin Score. So Modified Rankin Score had 1 more observation than primary outcomes.|||units on a scale||95% Confidence Interval|Least Squares Mean
2599977|NCT02168842|Secondary|Adjusted Mean Change in SE/ADL|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the SE/ADL in the active treatment arm versus placebo between the baseline and 36 month visit. The change of UPDRS ranges from -70 to 20, larger value shows improvement of PD.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline SE/ADL measurement. So SE/ADL had 1 more observation than primary outcomes.|||units on a scale||95% Confidence Interval|Least Squares Mean
2599978|NCT02168842|Secondary|Adjusted Mean Change in UPDRS Part III OFF|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Part III OFF rating in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Part III OFF ranges from -30 to 100, larger value shows more disability from PD.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population. 58 patients had missing measures at the visit of 36 months.|||score on a scale||95% Confidence Interval|Least Squares Mean
2599979|NCT02168842|Secondary|Adjusted Mean Change in UPDRS Part II|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Part II (ADL Function) in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Part II ranges from -12 to 19, larger value shows more disability from PD.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population|||score on a scale||95% Confidence Interval|Least Squares Mean
2599980|NCT02168842|Secondary|Adjusted Mean Change in UPDRS Score to 1 Year|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MDS-UPDRS nmEDL(Non-Motor Experiences of Daily Living) in the active treatment arm versus placebo between the baseline and 12 month visit. The change of UPDRS ranges from -22 to 23, larger value shows more disability from PD.|Baseline to 12 months of treatment|Intention-to-treat (ITT) population. There were 169 patients in Isradipine group and 165 in placebo group who reached 1-year visit.|||score on a scale||95% Confidence Interval|Least Squares Mean
2599981|NCT02168842|Secondary|Adjusted Mean Change in MDS-UPDRS mEDL|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MDS-UPDRS mEDL(Motor Experiences of Daily Living) in the active treatment arm versus placebo between the baseline and 36 month visit. The change in MDS-UPDRS mEDL ranges from -8 to 35, larger value shows more disability from PD.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population|||score on a scale||95% Confidence Interval|Least Squares Mean
2599982|NCT02168842|Secondary|Adjusted Mean Change in MDS-UPDRS nmEDL|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the MDS-UPDRS nmEDL(Non-Motor Experiences of Daily Living) in the active treatment arm versus placebo between the baseline and 36 month visit. The change in MDS-UPDRS nmEDL ranges from -6 to 10, larger value shows more disability from PD.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population.|||score on a scale||95% Confidence Interval|Least Squares Mean
2599983|NCT02168842|Secondary|Adjusted Mean Change in UPDRS Part IV|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the UPDRS Part IV in the active treatment arm versus placebo between the baseline and 36 month visit. The change in UPDRS Part IV ranges from -10 to 10, larger value shows more disability from PD.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population. 46 patients had missing measures at the visit of 36 months.|||score on a scale||95% Confidence Interval|Least Squares Mean
2600028|NCT02168439|Other Pre-specified|Anxiolysis Satisfaction|"Likert scale parent, child life and proceduralist survey~5 point likert scale asking how satisfied the parent or proceduralist is with the anxiolysis from the medication.~1 being not satisfied at all, 3 neutral, 5 very satisfied."|Day 1||||units on a scale||Standard Deviation|Median
2599984|NCT02168842|Secondary|Adjusted Mean Change in LED Cumulative|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the LED(levodopa equivalent dose) cumulative in the active treatment arm versus placebo between the baseline and 36 month visit. The change of LED cumulative ranges from 0 to 1200000, larger value shows more disability from PD.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline LED Cumulative measurement. So LED Cumulative had 1 more observation than primary outcomes.|||mg||95% Confidence Interval|Least Squares Mean
2599985|NCT02168842|Secondary|Adjusted Mean Change in LED|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the LED(levodopa equivalent dose) in the active treatment arm versus placebo between the baseline and 36 month visit. The change of LED ranges from -100 to 3000, larger value shows more disability from PD.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population. One participant had missing baseline UPDRS sections while had finished baseline LED measurement. So LED had 1 more observation than primary outcomes.|||mg||95% Confidence Interval|Least Squares Mean
2599986|NCT02168842|Primary|Adjusted Mean Change in Adjusted UPDRS Score|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the adjusted UPDRS Score in the active treatment arm versus placebo between the baseline and 36 month visit. The change of adjusted UPDRS ranges from -100 to 150, larger value shows more disability from PD.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population|||score on a scale||95% Confidence Interval|Least Squares Mean
2599987|NCT02168842|Primary|Adjusted Mean Change in Total Unified Parkinson Disease Rating Scale (UPDRS) Score|Efficacy of isradipine to slow progression of Parkinson disease disability to be determined by the change in the total (Part I-III) UPDRS score in the active treatment arm versus placebo between the baseline and 36 month visit. The change of UPDRS ranges from -30 to 80, larger value shows more disability from PD.|Baseline to 36 months of treatment|Intention-to-treat (ITT) population|||score on a scale||95% Confidence Interval|Least Squares Mean
2599988|NCT02168816|Secondary|Number of Participants With Ulcer Resolution|Six months following completion of treatment, the researchers record whether each participant's ulcer has resolved.|Six Months|The analysis population comprises all randomized participants who had a six month follow-up appointment.|||Participants|||Count of Participants
2599989|NCT02168816|Primary|Number of Participants With Bone Infection|Six months following completion of treatment, the researchers record evidence of bone infection for each participant. A negative diagnosis is made when there is (i) an absence of infection based on clinical examination and (ii) down-trending of inflammatory markers. Otherwise, a positive diagnosis is made.|Six Months|The analysis population comprises all randomized participants who had a six month follow-up appointment.|||Participants|||Count of Participants
2599990|NCT02168803|Secondary|PD Parameters of Evacetrapib: Triglyceride Level||Day -1, Day 8|All enrolled participants who received at least 1 dose of study drug and had evaluable PD data.|||mmol||Standard Deviation|Mean
2599991|NCT02168803|Secondary|PD Parameters of Evacetrapib: Total Cholesterol Level||Day -1, Day 8|All enrolled participants who received at least 1 dose of study drug and had evaluable PD data.|||mmol||Standard Deviation|Mean
2599992|NCT02168803|Secondary|PD Parameters of Evacetrapib: Low-Density Lipoprotein Cholesterol (LDL-C) Level||Day -1, Day 8|All enrolled participants who received at least 1 dose of study drug and had evaluable PD data.|||mmol/L||Standard Deviation|Mean
2599993|NCT02168803|Secondary|PD Parameters of Evacetrapib: High Density Lipoprotein Cholesterol (HDL-C) Level||Day -1, Day 8|All enrolled participants in the single dose phase and had evaluable PD data.|||millimole/Liter (mmol/L)||Standard Deviation|Mean
2599994|NCT02168803|Primary|PK Parameters of Evacetrapib: Terminal Half-life||Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose|A single terminal half-life estimate was calculated from population PK estimates for apparent clearance and apparent volume of distribution across all participants, based on all available single dose data and multiple dose data.|||Days|||Number
2599995|NCT02168803|Primary|PK Parameters of Evacetrapib: Maximum Concentration (Cmax)||Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose|All enrolled participants who received at least 1 dose of study drug and had evaluable PK data.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2599996|NCT02168803|Primary|Pharmacokinetics (PK) Parameters of Evacetrapib: Area Under the Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast])||Single-Dose: 1,2,3,4,6,8,12,24,36,48,72,120,168 Hours Postdose; Multiple Dose: Predose, 1,2,3,4,6,8,12,24,36,48,72,120,168 hours; 10,13,17,20,24,29,36,43,50,57, and 71 Days Post Dose|All enrolled participants who received at least 1 dose of study drug and had evaluable PK data.|||nanogram∙hour/mililliter (ng∙h/mL)||Geometric Coefficient of Variation|Geometric Mean
2599997|NCT02168777|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|Dose-limiting toxicities (DLTs) were analyzed in the maximum tolerated dose (MTD) analysis set, in which only the six first patients of each dose escalation Cohort could be included according to the modified Rolling-6 method that was applied in this study.|At Cycle 1|MTD analysis set: all participants who completed Cycle 1 or discontinued during Cycle 1 due to an adverse event or DLT in the dose escalation part.|||Participants|||Number
2599998|NCT02168777|Secondary|Progression-free Survival During Phase 2|Progression-free survival was defined as the time from date of treatment assignment to date of first observed disease progression or death due to any cause, if death occurred while the participant was in the study and before progression was observed.|From start of treatment until progression is documented|Phase 2 part was not conducted.||||||
2599999|NCT02168777|Secondary|Time to Progression During Phase 2|Time to progression was defined as the time (days) from the treatment start date to the disease progression on or following the start date. Participants not experiencing progression at the database cutoff date for primary completion were censored at the last assessment.|From start of treatment until progression is documented|Phase 2 part was not conducted.||||||
2600029|NCT02168439|Other Pre-specified|Need for Procedural Sedation|Whether the patient required procedural sedation for completion of the procedure|Day 1||||percentage of participants|||Number
2600000|NCT02168777|Secondary|Overall Survival During Phase 2|Overall survival (OS) was defined as the time (days) from the treatment start date to the date of death due to any cause. For participants who were still alive or who were lost to follow-up as of the database cutoff date for the primary completion, OS was censored at the last known alive date on or prior to the database cutoff date.|Up to 12 months after last patient first visit|Phase 2 part was not conducted.||||||
2600001|NCT02168777|Secondary|Tumor Response During Phase 1b as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Tumor Response was defined as the best tumor response (Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target and non-target tumor lesions, PR was defined as a decrease of at least 30% in the sum of diameters of target lesions, SD was defined neither sufficient shrinkage for PR nor sufficient increase for PD, PD was defined as an increase of at least 20% in the sum of diameters of target lesions.|From start of treatment until progression is documented|Full analysis set|||Participants|||Number
2600002|NCT02168777|Secondary|Time to Reach Maximum Drug Concentration in Plasma After Multiple Dose (Tmax,md) for Regorafenib and Its Metabolites M-2 and M-5|Time to reach maximum drug concentration in plasma after multiple dose for Regorafenib and its metabolites M-2 and M-5. Median and full range were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose|PK analysis set for multiple dose. On Day 21, one patient in Cohort 0 was dose reduced and the other patient was not dosed. Therefore no patient was evaluable.|||h||Full Range|Median
2600003|NCT02168777|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 24 h (AUC(0-24)) After Single (First) Dose for Regorafenib and Its Metabolites M-2 and M-5|Area under the plasma concentration-time curve from 0 to 24 h after single (first) dose for Regorafenib and its metabolites M-2 and M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 24 hours post-dose|PK analysis set for single dose.|||μg*h/L||Geometric Coefficient of Variation|Geometric Mean
2600004|NCT02168777|Secondary|Time to Reach Maximum Drug Concentration in Plasma After Single (First) Dose (Tmax) for Regorafenib and Its Metabolites M-2 and M-5|Time to reach maximum drug concentration in plasma after single (first) dose for Regorafenib and its metabolites M-2 and M-5. Median and full range were reported.|Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 24 hours post-dose|PK analysis set for single dose.|||h||Full Range|Median
2600005|NCT02168777|Secondary|Maximum Drug Concentration in Plasma After Single (First) Dose (Cmax) for Regorafenib and Its Metabolites M-2 and M-5|Maximum drug concentration in plasma after single (first) dose for Regorafenib and its metabolites M-2 and M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 24 hours post-dose|PK analysis set for single dose.|||μg/L||Geometric Coefficient of Variation|Geometric Mean
2600006|NCT02168777|Secondary|Time to Reach Maximum Drug Concentration in Plasma After Multiple Dose (Tmax,md) for Refametinib and Its Metabolite M-11|Time to reach maximum drug concentration in plasma after multiple dose for Refametinib and its metabolite M-11. Median and full range were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose|PK analysis set for multiple dose. On Day 21, one patient in Cohort 0 was dose reduced and the other patient was not dosed. Therefore no patient was evaluable.|||h||Full Range|Median
2600007|NCT02168777|Secondary|Area Under the Plasma Concentration-time Curve From 0 to 8 h (AUC(0-8)) After Single (First) Dose for Refametinib and Its Metabolite M-11|Area under the plasma concentration-time curve from 0 to 8 h after single (first) dose for Refametinib and its metabolite M-11. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4 and 8 hours post-dose|PK analysis set for single dose.|||μg*h/L||Geometric Coefficient of Variation|Geometric Mean
2600008|NCT02168777|Secondary|Time to Reach Maximum Drug Concentration in Plasma After Single (First) Dose (Tmax) for Refametinib and Its Metabolite M-11|Time to reach maximum drug concentration in plasma after single (first) dose for Refametinib and its metabolite M-11. Median and full range were reported.|Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4 and 8 hours post-dose|PK analysis set for single dose.|||h||Full Range|Median
2600009|NCT02168777|Secondary|Maximum Drug Concentration in Plasma After Single (First) Dose (Cmax) for Refametinib and Its Metabolite M-11|Maximum drug concentration in plasma after single (first) dose for Refametinib and its metabolite M-11. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 1 at 0 (pre-dose), 0.5, 1, 2, 4 and 8 hours post-dose|PK analysis set for single dose.|||μg/L||Geometric Coefficient of Variation|Geometric Mean
2600010|NCT02168777|Primary|Tumor Response During Phase 2 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Tumor Response was defined as the best tumor response (Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as disappearance of tumor lesions, PR was defined as a decrease of at least 30% in the sum of tumor lesion sizes, SD was defined as steady state of disease, PD was defined as an increase of at least 20% in the sum of tumor lesions sizes.|Up to 12 months|Phase 2 part was not conducted.||||||
2600011|NCT02168777|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 h After Multiple Dose (AUC(0-24)md) for Regorafenib Metabolite M-5|Area under the plasma concentration-time curve from 0 to 24 h after multiple dose for Regorafenib metabolite M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose|PK analysis set for multiple dose.|||μg*h/L||Geometric Coefficient of Variation|Geometric Mean
2600012|NCT02168777|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 h After Multiple Dose (AUC(0-24)md) for Regorafenib Metabolite M-2|Area under the plasma concentration-time curve from 0 to 24 h after multiple dose for Regorafenib metabolite M-2. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose|PK analysis set for multiple dose.|||μg*h/L||Geometric Coefficient of Variation|Geometric Mean
2600030|NCT02168439|Other Pre-specified|Procedure Completion|note of whether the procedure was able to be completed|Day 1||||percentage of participants|||Number
2600013|NCT02168777|Primary|Area Under the Plasma Concentration-time Curve From 0 to 24 h After Multiple Dose (AUC(0-24)md) for Regorafenib|Area under the plasma concentration-time curve from 0 to 24 h after multiple dose for Regorafenib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose|PK analysis set for multiple dose.|||μg*h/L||Geometric Coefficient of Variation|Geometric Mean
2600014|NCT02168777|Primary|Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Regorafenib Metabolite M-5|Maximum drug concentration in plasma after multiple dose for Regorafenib metabolite M-5. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose|PK analysis set for multiple dose.|||μg/L||Geometric Coefficient of Variation|Geometric Mean
2600015|NCT02168777|Primary|Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Regorafenib Metabolite M-2|Maximum drug concentration in plasma after multiple dose for Regorafenib metabolite M-2. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose|PK analysis set for multiple dose.|||μg/L||Geometric Coefficient of Variation|Geometric Mean
2600016|NCT02168777|Primary|Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Regorafenib|Maximum drug concentration in plasma after multiple dose for Regorafenib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8, 12 and 24 hours post-dose|PK analysis set for multiple dose.|||μg/L||Geometric Coefficient of Variation|Geometric Mean
2600017|NCT02168777|Primary|Area Under the Plasma Concentration-time Curve From 0 to 12 h After Multiple Dose (AUC(0-12)md) for Refametinib Metabolite M-11|Area under the plasma concentration-time curve from 0 to 12 h after multiple dose for Refametinib metabolite M-11. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose|PK analysis set for multiple dose.|||μg*h/L||Geometric Coefficient of Variation|Geometric Mean
2600018|NCT02168777|Primary|Area Under the Plasma Concentration-time Curve From 0 to 12 h After Multiple Dose (AUC(0-12)md) for Refametinib|Area under the plasma concentration-time curve from 0 to 12 h after multiple dose for Refametinib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose|PK analysis set for multiple dose.|||μg*h/L||Geometric Coefficient of Variation|Geometric Mean
2600019|NCT02168777|Primary|Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Refametinib Metabolite M-11|Maximum drug concentration in plasma after multiple dose for Refametinib metabolite M-11. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose|PK analysis set for multiple dose.|||μg/L||Geometric Coefficient of Variation|Geometric Mean
2600020|NCT02168777|Primary|Maximum Drug Concentration in Plasma After Multiple Dose (Cmax,md) for Refametinib|Maximum drug concentration in plasma after multiple dose for Refametinib. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|Cycle 1 Day 21 at 0 (pre-dose), 0.5, 1, 2, 4, 8 and 12 hours post-dose|Pharmacokinetic (PK) analysis set for multiple dose.|||μg/L||Geometric Coefficient of Variation|Geometric Mean
2600021|NCT02168660|Secondary|Change in BMI Z-score|"The change in BMI z-score from baseline to end-of-study visit; i.e., the value at the later time point minus the value at the earlier time point.~The BMI Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched children). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population."|4-12 mo after randomization (4 months after target 25-hydroxyvitamin D level is reached).||||z-score||Inter-Quartile Range|Median
2600022|NCT02168660|Secondary|Time to Normalization of Vit D Level Versus BMI Z Score|The time required to reach a normal Vitamin D level (> 30) versus BMI Z score at each vitamin D3 dose; OR vitamin D level at 6 weeks versus BMI Z score at each starting vitamin D3 dose.|1 to 12 months|Timing of sample collections was too irregular to permit analysis.||||||
2600023|NCT02168660|Primary|Change in HOMA-IR|Change in HOMA-IR from initial visit to end-of-study visit; i.e., the value at the later time point minus the value at the earlier time point. HOMA-IR= Fasting insulin (mIU/ml) x Fasting glucose (mg/dl) / 405.|4-12 mo after randomization (4 months after target 25-hydroxyvitamin D level is reached).|Beginning and ending anthropometric data were available within the specified time limits on 61 subjects and 25-hydroxyvitamin D3 (25-OHD) levels on 45. Corresponding insulin and glucose data (allowing calculation of HOMA-IR) were available on only 26 subjects, mainly because many 25-OHD levels were obtained when subjects were not fasting.|||HOMA-IR score||Inter-Quartile Range|Median
2600024|NCT02168491|Secondary|Change in Body Weight From Baseline to End of Study|A change between two time points is reported. Time Frame: baseline and 12 weeks.|12 weeks||||weight in kg||Standard Deviation|Mean
2600025|NCT02168491|Secondary|Change in Fasting Plasma Glucose (FPG, Mean Over 2 Weeks)|"Patients will be instructed to record all insulin injections and a complete 7-point-blood glucose profile (fasting, 2h after breakfast, before lunch, 2h after lunch, before dinner, 2h after dinner, late before going to bed) during a one-week prestudy run-in period to confirm compliance and document current metabolic control and doses of premixed insulin.~Patients will be asked to record not only glucose profiles (at least 4 measurements per day) but also the occurrence of hypoglycemic symptoms or other adverse effects daily throughout the study.~During the last week of the study patients will be asked to again record a complete 7-point-blood glucose profile (fasting, 2h after breakfast, before lunch, 2h after lunch, before dinner, 2h after dinner, late before going to bed) and drug injections to confirm compliance and document metabolic control."|12 weeks||||glucose in mg/dl||95% Confidence Interval|Mean
2600026|NCT02168491|Primary|Change in HbA1c From Baseline to End|A change between two time points is reported. Time Frame: baseline and 12 weeks.|12 weeks||||HbA1c in percent||Standard Deviation|Mean
2600027|NCT02168478|Primary|Evidence of Pre-Existing Sensitization by Use of the Erythemal Scoring Scale (ESS)|"ESS is measured at 48, 96 and 168 hours post-application of study material. The Erythemal Scoring Scale (ESS) is defined as a 6 point scale (0-4). 0= no visible erythema; 0.5= slight, barely perceptible erythema; 1= mild erythema; 2= moderate erythema; 3= marked erythema; 4= severe erythema. An ESS score of 1 or greater that persists or worsens from one visit to the next is defined as pre-existing sensitization."|48, 96 and 168 Hours||||percentage of patients w allergic rxn|||Number
2600031|NCT02168439|Secondary|VAS for Anxiety as Completed by Caregiver and Observer|"VAS, Visual Analog Scale for anxiety. Scale from 0-10 written on a 10 cm horizontal line with the extremes labeled as no anxiety to very anxious.~Vertical line is drawn on the scale at the level of anxiety. The distance was measured.~Higher numbers equal higher anxiety."|Day 1||||units on a scale||Standard Deviation|Mean
2600032|NCT02168439|Secondary|mYPAS Scores at Other Time Points|mYPAS stands for modified Yale Preoperative anxiety scale. The scale is from minimum 23.3- maximum 100. Higher scores indicate higher anxiety. By prior characterization, scores less than or equal to 30 are classified as not anxious.|Day 1||||units on a scale||95% Confidence Interval|Median
2600033|NCT02168439|Primary|mYPAS Score as Completed by Researchers to Assess Anxiety|"Primary outcome was the mYPAS scores at the time of positioning for procedure.~mYPAS stands for modified Yale Preoperative anxiety scale. The scale is from minimum 23.3- maximum 100. Higher scores indicate higher anxiety. By prior characterization, scores less than or equal to 30 are classified as not anxious."|Day 1||||units on a scale||95% Confidence Interval|Median
2600034|NCT02168387|Secondary|Change in Quantity and Quality of Suctioned Mucus||baseline and 48 hours|These data were not obtained due to technical difficulties.||||||
2600035|NCT02168387|Secondary|Change in Capnography (Vd/Vt)|The deadspace-to-tidal volume (Vd/Vt) ratio is a parameter that is measured in mechanically ventilated patients as a way to assess the severity of gas exchange impairment and to assist in determining whether a patient is ready to be weaned from the ventilator. The change from baseline was measured at 48 hours, with a decreasing ratio indicating improvement.|baseline and 48 hours||||ratio||Standard Deviation|Mean
2600036|NCT02168387|Primary|Improvement of Atelectasis|"An atelectasis score (AS), as published by Deakins, et al. 2002, was assigned to each radiograph as follows:~0 Complete resolution of collapse~Partial collapse of 1 segment or lobe~Partial collapse of ≥ 2 segments or lobes~Complete collapse of 1 segment or lobe~Complete collapse of ≥ 2 segments or lobes~In the event of inter-rater disagreement, the scores were averaged. Improvement was defined as any decrease in AS ≥ 0.5. Worsening was defined as an increase in AS ≥ 0.5 or escalation of respiratory support modality (i.e. high frequency ventilation)."|after 48 hours of therapy||||participants|||Number
2600037|NCT02168361|Secondary|Serum HCV RNA Level||4 and 12 weeks into therapy|All participants that received at least a single dose of medication|||IU/ml||Full Range|Median
2600038|NCT02168361|Primary|Proportion of Participants With Sustained Virologic Response 12 (SVR-12)|Undetectable virus (sensitive nucleic acid test) in Serum at 3 months post-therapy|12 weeks post-therapy|All participants that received at least a single dose of medication|||participants|||Number
2600039|NCT02168309|Secondary|Total Length of Hospital Stay in Days|Secondary outcome|0-10 days||||days||Standard Deviation|Mean
2600040|NCT02168309|Primary|Time (Hours) to Attain Sustained Blood Pressure Goal After Treatment Initiated With Antihypertensive Medication|Primary outcome|24 hours||||hours||Standard Deviation|Mean
2600041|NCT02168270|Secondary|Using Radiologic Measurements for Tumor Response|The measurement of effect will be based on the Macdonald criteria|Up to 52 weeks|This outcome measure was not analyzed as all patients had progressive disease by 2 cycles of treatment.||||||
2600042|NCT02168270|Secondary|Changes in Serum Levels of Ascorbic Acid (Using HPLC With Coulometric Electrochemical Detection)|Correlation of intracellular glutathione (in peripheral blood mononuclear cells) with ascorbic acid levels during therapy with ascorbic acid and temozolomide will be summarized using descriptive statistics to summarize changes over time.|Baseline to up to 52 weeks|No patients were analyzed as all experienced progressive disease after 2 cycles of treatment.||||||
2600043|NCT02168270|Primary|Incidence Rates of Adverse Events, Graded According to the NCI Common Toxicity Criteria for Adverse Events Version 4.0|The incidence rates of adverse events will be described by dose level. The frequency of occurrence of overall toxicity, categorized by toxicity grades, will be described.|Up to 30 days after last administration of study medication|This study was terminated after only 4 patients enrolled. Incidence rates of adverse event could not be describe by dose level.||||||
2600044|NCT02168270|Primary|Maximum Tolerated Dose of Ascorbic Acid in Combination With Temozolomide, Defined as the Highest Dose Tested Which Results in Dose Limiting Toxicity (DLT) in no More Than One of Six Evaluable Patients|Graded by the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events version 4.0. DLT incidence will be described by dose level.|56 days|This study was terminated as subjects had disease progression so no subjects were evalable.||||||
2600045|NCT02168153|Primary|Response Time Involving Whole Body Movement (T-wall)|Participants will stand in front of the t-wall which is a commercially available device with a 4 x 8 foot bank of square buttons that are each 8 cm per side. When test is begun, one of the buttons lights up. The participant hits that button with either hand. The light inside that button then goes out and another button lights up until that one is hit. This process continues for a random sequence of 100 buttons. When last button is hit, all the buttons light up momentarily to indicate that the test is over. The measured outcome from this test is the time from when the first button is hit to when the last of the random sequence of 100 buttons is hit.|Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit|3 participants in the Chiropractic group were lost to follow-up.|||millisecond (ms)||Standard Deviation|Mean
2600046|NCT02168153|Primary|Response Time Involving the Dominant Hand (Fitts Law Test)|Participants perform a computerized simple target acquisition task (a Fitts Law task) to investigate their response times using a mouse with their dominant hand. The participant will complete a block, a series of target selections on a computer monitor, by working through 32 trials. That is, 32 pairs of 'hits' - meaning the mouse was clicked when the cursor was inside each of two circles that appear on the screen. The measured outcome from this task will be the sum of the times required to complete each trial.|Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit|3 participants in the Chiropractic group were lost to follow-up.|||millisecond (ms)||Standard Deviation|Mean
2600056|NCT02167893|Secondary|Percentage of Participants With Disease-specific Survival|Disease-specific survival is defined as time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.|Baseline up to 96 weeks|No results have been reported in this measure because as predefined in the protocol, the outcome measure was not planned to be assessed.||||||
2613228|NCT02023866|Secondary|Change From Baseline in Glutathione Disulfide||Baseline and Weeks 4, 8, 12, 16, 20, 24|PD analysis set participants with available data at each time point.|||µmol/L||Standard Deviation|Mean
2600047|NCT02168153|Primary|Choice Reaction Time|Prompts on the screen will occur with the same time interval (1 second) in between the press of a button or pedal in response to one prompt and the appearance of the next prompt. Each prompt could be for either hand or either foot and the position of the prompt on the computer screen will indicate which thumb or foot should be used. If the wrong button or pedal is pressed, the software still goes on to the next prompt, but keeps track of how many incorrect responses were made. A set consists of a sequence of 41 prompts. The outcome variable for this test, mean reaction time, is the average length of time between each prompt's appearance and the participant's response.|Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit|3 participants in the Chiropractic group were lost to follow-up.|||Millisecond (ms)||Standard Deviation|Mean
2600048|NCT02168153|Primary|Simple Reaction Time With the Dominant Foot|This test will be done in a manner similar to that for the dominant hand except that the participants will press a pedal with their dominant foot.|Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit|Missing data for the simple foot reaction tests are due to a technical problem in early data collection. Once identified, the problem was corrected. Because data collected before the technical issue was corrected were unreliable and likely inaccurate, they were not included in the analysis for this measure.|||millisecond (ms)||Standard Deviation|Mean
2600049|NCT02168153|Primary|Simple Reaction Time With the Dominant Hand|Handedness of the participants will be determined on the basis of self-report. The subject will react to the appearance of visual prompts on the screen by pressing a button with the thumb of their dominant hand. A set consists of 11 prompts shown in sequence with a time period between the response to one prompt and the appearance of the next prompt ranging from 0.5 to 4.0 seconds in random order. The outcome variable for this test, the mean reaction time, is the average of the length of time between the appearance of each prompt and the press of the button in response to that prompt.|Week 1-Study Visit 2, Week 2-Final Visit, Change from Visit 2 to Final Visit|Missing data for the simple hand reaction tests are due to a technical problem in early data collection. Once identified, the problem was corrected. Because data collected before the technical issue was corrected were unreliable and likely inaccurate, they were not included in the analysis for this measure.|||millisecond (ms)||Standard Deviation|Mean
2600050|NCT02168101|Secondary|Number of Participants With Incidence of Acute Graft-versus-host Disease (aGVHD) After Receiving Allogeneic Stem Cell Transplant and Maintenance With MLN9708|Incidence of acute Graft-versus-host disease GVHD was assessed based on the National Institutes of Health Consensus Development Project on Criteria for Clinical trials in Acute and Chronic Graft-versus-host-disease (Przepiorka et al. 1995) from date of randomization until date of first documented progression, or date of death from any cause.|from date of enrollment every 28 days, up to 2 years||||Participants|||Count of Participants
2600051|NCT02168101|Secondary|Number of Participants With Incidence of Chronic Graft-versus-host Disease (cGVHD) After Receiving Allogeneic Stem Cell Transplant and Maintenance With MLN9708|Incidence of chronic Graft-versus-host disease GVHD was assessed based on the National Institutes of Health Consensus Development Project on Criteria for Clinical trials in Acute and Chronic Graft-versus-host-disease (Filipovich et al. 2005) from date of randomization until date of first documented progression, or date of death from any cause.|from date of enrollment every 28 days, up to 2 years||||Participants|||Count of Participants
2600052|NCT02168101|Secondary|Median Overall Survival (OS) at 2 Years Post-allogeneic Stem Cell Transplant (ASCT)|Overall survival is measured as the interval from first study treatment until date of death, or date last known alive.|every 8 weeks for approximately 24 weeks after ASCT, then every 3 months thereafter for 2 years.|All patients with measurable or evaluable disease at baseline who receive at least 1 dose of MLN9708 and undergo at least one post-baseline disease assessment. Pre-specified in Protocol to calculate PFS for all participants and for all patients receiving the MTD. Because the MTD was not reached, this analysis was only performed on all participants.|||months||95% Confidence Interval|Median
2600053|NCT02168101|Secondary|Median Progression-Free Survival (PFS) at 2 Years Post-maintenance Therapy|PFS is measured from the date of first protocol treatment until date of disease progression or death occurs, or date of last adequate tumor assessment using the International Myeloma Working Group Uniform Response Criteria. IMWG disease progression is defined as an increase of ≥ 25% from the nadir in at least one of the following criteria: 1) serum M-protein, 2) urine M-protein, 3) only in patients with non-measurable serum and urine M-protein levels: difference in involved and uninvolved FLC levels, 4) Bone marrow plasma cell percentage (absolute % must be ≥10%). OR Disease progression also could include development of new lytic bone lesions or increase from baseline in size of lytic bone lesion(s); development of new soft tissue plasmacytoma(s) or definite increase from nadir in existing soft tissue plasmacytomas; or development of hypercalcemia|every 8 weeks for approximately 24 weeks then every 3 months thereafter for 2 years|All patients with measurable or evaluable disease at baseline who receive at least 1 dose of MLN9708 and undergo at least one post-baseline disease assessment. Pre-specified in Protocol to calculate PFS for all participants and for all patients receiving the MTD. Because the MTD was not reached, this analysis was only performed on all participants.|||months||95% Confidence Interval|Median
2600054|NCT02168101|Primary|Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety of MLN9708 When Used as Maintenance After Allogeneic Stem Cell Transplant for Multiple Myeloma Multiple Myeloma|Defined as the number of participants with treatment-emergent grade 3/4/5 adverse events/serious adverse events utilizing the National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v4.0 determined to be related to MLN9708.|Defined as the time from Day 1 of study drug administration until 30 days after treatment completion for up to 2 years.|All patients who received at least one dose of MLN9708.|||Participants|||Count of Participants
2600055|NCT02168101|Primary|Number of Phase I Patients Receiving 2.3mg, 3mg, or 4mg MLN9708 Experiencing a Dose-Limiting Toxicity (DLT) to Determine the Maximum Tolerated Dose|The maximum tolerated dose (MTD) of MLN9708 will be determined as the dose at which ≤1 of 6 patients experiences a DLT during one cycle (28 days) of therapy utilizing the National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v4.0|Collected from day of first dose to the end of the first treatment cycle, up to 28 days|All patients who received at least one dose of MLN9708.|||Participants|||Count of Participants
2600057|NCT02167893|Secondary|Percentage of Participants With Metastasis-free Survival||Baseline up to 96 weeks|No results have been reported in this measure because as predefined in the protocol, the outcome measure was not planned to be assessed.||||||
2600058|NCT02167893|Secondary|Percentage of Participants With Overall Survival (OS) Based on TNM Classification|OS was defined as the duration from randomization to death (due to any cause). Probability of OS was reported using Kaplan-Meier method. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=<2 centimeter (cm), T2=2-5 cm, T3=>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread >10 axillary LN, M0=no metastasis, M1= Metastasis.|Baseline up to 96 weeks or death (which ever occurs first)|The efficacy assessment population was defined as all participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants||95% Confidence Interval|Number
2600059|NCT02167893|Secondary|Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification|PFS was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=<2 centimeter (cm), T2=2-5 cm, T3=>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread >10 axillary LN, M0=no metastasis, M1= Metastasis.|Baseline up to 96 weeks|The efficacy assessment population was defined as all participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants||95% Confidence Interval|Number
2600060|NCT02167893|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 96|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
2600061|NCT02167893|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to Week 96|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
2600062|NCT02167867|Primary|Average Change in Inches of Total Circumference Measurements for the Treatment Subject Group After 2 Weeks of Treatment With the ZERONA Z6|Circumference in inches for the waist, hips and both thighs were measured and added together to give a total circumference measurement at baseline and at the end of the 2 weeks of treatment. The change in the total circumference measurement from baseline to the end of treatment was calculated. A decrease (-) in circumference measurement suggests study success and an increase (+) in circumference measurement suggests study failure. A decrease (-) of 3.52 inches (-3.52 inches) or more is positive for study success based on prior published results.|Baseline and 2 weeks||||inches||Standard Deviation|Mean
2600063|NCT02167867|Primary|Lay End User Ability to Correctly Use the ZERONA Z6 and Follow the Treatment Directions.|The number of lay end users who correctly used the ZERONA Z6 to administer treatments by following the treatment administration protocol was calculated|two weeks||||participants|||Number
2600064|NCT02167867|Primary|Lay End User Ability to Correctly Choose Suitably Qualified Individuals to Get the ZERONA Z6 Treatments|The number of lay end users who correctly evaluated and selected fully qualified individuals to get the ZERONA Z6 treatment was calculated.|Baseline||||participants|||Number
2600065|NCT02167815|Secondary|Measure of Actual Dressing Cost and Cost of Care, as Input for Health Economics Calculations.||16 weeks|the way to collect data differed to much betwen the sites, no analysis could be done.||||||
2600066|NCT02167815|Secondary|Users Feedback After Handling or Use as a Measure of Performance.|"Investigator/Nurse and Subject evaluation of performance of the primary dressing ( n) Scale= Good , Very Good, Poor, Very Poor~1Ease of application, 2 Ease of removal, 3 Ability to retain exudate, 4 Adherence to healthy skin, 5 Confomability to be repositioned , 6 Overall satisfaction, 7 Dressing sticking to wound bed, 8 Presence of residues on the wound bed. 9 Presence of residues on the healthy skin. 10 Overall evaluation of change in periwound skin condition."|16 weeks||||participants|||Number
2600067|NCT02167815|Secondary|Pain Scores on the Visual Analog Scale|Pain at baseline visit, compared with pain at week 16. VAS scale, minimum pain = 0, maximum pain = 100.|16 weeks||||units on a scale (VAS)||Standard Deviation|Mean
2600068|NCT02167815|Primary|Changes From Baseline in Condition of the Peri Wound Skin|Deteriorationin of skin condition , Mepilex XT and Standard care (%)|16 weeks|Intention to treat, change from baseline in condition of the peri-wound skin.|||percentage of subjects|||Number
2600069|NCT02167451|Secondary|Time to Platelet Engraftment|Time to achieve platelets count of 20,000 without transfusions|days||||days||Full Range|Median
2600070|NCT02167451|Secondary|Time to Neutrophil|Neutrophil engraftment is defined as the first of three consecutive measurements of ANC>500mcL over 3 or more days.|Up to day +100||||days||Full Range|Median
2600071|NCT02167451|Secondary|Infectious Complications|Infections complications which include asymptomatic viremias for EBV, Adenovirus, CMV, and/or viral disease, bacterial and fungal infections as documented by blood cultures.|Up to day +100||||patients|||Number
2600072|NCT02167451|Secondary|Toxicities|Incidence of toxicities due to drug|Up to day +100||||Participants|||Count of Participants
2600073|NCT02167451|Secondary|Primary Disease Relapse||By day +100||||Participants|||Count of Participants
2600074|NCT02167451|Secondary|Graft Failure|Failure to engraft and loss of graft.|By day +100||||Participants|||Count of Participants
2600078|NCT02167451|Primary|Area Under The Concentration-Time Curve (AUC) of Maraviroc|pK target >100ng/ml at day zero at the following time points : before the dose and 1, 2, 4, 6, 8, and 12 hours after maraviroc administration|Day 0||||hour *ng/mL||Standard Deviation|Mean
2600079|NCT02167451|Primary|GVHD Incidence|Incidence of GVHD by day+100|By day +100||||Participants|||Count of Participants
2600080|NCT02167451|Primary|Feasibility of Maraviroc|The ability to administer twice daily oral maraviroc in children and adults undergoing stem cell transplant in addition to routine standard graft versus host disease prophylaxis.|Up to day +100||||Participants|||Count of Participants
2600081|NCT02167256|Secondary|Change in Brain Glucose Uptake Measured Using 18F-FDG PET Imaging|The results from the primary outcome with brain FDG-PET imaging was analyzed by ApoE genotype. Composite measure of brain glucose uptake using F18-FDG PET in a pre-defined set of brain regions, between baseline and 12 months.|12 months|Number of participants is lower than total randomized participants due to a modified intent-to-treat analysis where only randomized participants who also underwent a post-baseline F18-FDG PET brain scan are included.|||umol/100g/min (change)||Standard Deviation|Mean
2600082|NCT02167256|Secondary|Cerebrospinal Fluid Levels of Total Tau, Phospho-tau (p-Tau), and Amyloid-beta 1-42 (Abeta 1-42)|Measure concentration of Tau and Amyloid-beta 1-42 biomarkers in the cerebrospinal fluid between baseline and 12 months of treatment|12 months|Number of participants is lower than total randomized participants due to a modified intent-to-treat analysis where only randomized participants who also underwent a post-baseline cerebrospinal fluid analysis were included.|||pg/ml||Standard Deviation|Mean
2600083|NCT02167256|Secondary|Percent Change in Brain Volume Before and After Treatment|Change in volume of pre-defined brain regions between baseline and 12 months of treatment.|12 months||||% change in volume||Standard Error|Mean
2600084|NCT02167256|Secondary|The Effect of Treatment With AZD0530 on Cognitive and Behavioral Function|"The change in cognitive function between baseline and 12 months will be measured by the following tests:~Alzheimer Disease Assessment Scale - Cognitive 11 (ADAS-cog11). Measures: Cognitive function Maximum score: 70; Minimum score: 0. Higher score equals worse cognitive function~Mini-Mental State Examination (MMSE) Measures: Cognitive Function Maximum score: 30; Minimum score: 0. Higher score equal better cognitive function~Alzheimer Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Measures: Ability to perform routine daily activities Maximum score: 78; Minimum score: 0. Higher score equals better ability to perform activities of daily living~Clinical Dementia Rating Sum of Boxes (CDR-SO) Measures: Dementia severity Maximum score: 18; Minimum score: 0. Higher score equals more severe dementia."|12 months||||Scores on a scale||Standard Error|Mean
2600085|NCT02167256|Primary|Number of Participants With One or More Serious/Other Adverse Events Subjects With Mild AD as Assessed by Analysis of Adverse Events, Including Symptoms, and Abnormal Findings on Physical and Neurological Examinations, and Standard Labs.|Assessment of any adverse effects between drug and placebo-treated subjects|12 months||||Participants|||Count of Participants
2600086|NCT02167256|Primary|Change in Brain Glucose Uptake Measured Using 18F-FDG PET Imaging|Composite measure of brain glucose uptake using F18-FDG PET in a pre-defined set of brain regions, between baseline and 12 months.|12 months|Number of participants is lower than total randomized participants due to a modified intent-to-treat analysis where only randomized participants who also underwent a post-baseline F18-FDG PET brain scan are included.|||umol/100g/min (change)||Standard Deviation|Mean
2600087|NCT02167217|Primary|Bayley III Gross Motor Scaled Score (Change From Baseline to 12 Month)|Bayley III Gross Motor Scaled Score measures motor development. This is normed for typically developing children and follow a bell shaped curve. The scale has mean of 10 +/-3 for children at all ages and is bell shaped. Therefore the two standard deviation range is 16 to 4 with higher values indicated better performance. Lower values have been shown to be common in boys with DMD and it this study the baseline average score was 4.2.|One year|We analyzed the change in the gross motor score after one year. An increase indicates improvement compared to peers|||units on a scale||Standard Deviation|Mean
2600088|NCT02167204|Primary|Clinical Response Assessed Using Revised Assessment in Neuro-Oncology Criteria|This is clinical response as assessed at physician discretion using standard of care criteria.|Up to 7 years|Data not collected for this Outcome Measure||||||
2600089|NCT02167204|Primary|Survival|Time from study entry to death will be recorded|Up to 7 years|All patients with at least one 18F-FLT/CT study|||months||Full Range|Median
2600090|NCT02167204|Primary|Percentage Change in Measure of Standard Uptake Value|The percentage change in the maximum standard uptake value (SUVmax) was recorded. SUVmax is defined as the amount of FLT uptake in a lesion.|Baseline to up to 1 year after completion of treatment|4 patients had 2 scans, 2 patients had 3 scans|||percent change||Full Range|Median
2600091|NCT02167204|Primary|Percentage Change in Measure of Reflecting Transport|The percentage change in the kinetic model parameter of FLT transport (K1) was recorded. K1 is defined as the transfer of FLT from blood into tissue (tumor).|Baseline to up to 1 year after completion of treatment|4 patients had 2 scans and 2 had 3 scans.|||percent change||Full Range|Median
2600092|NCT02167204|Primary|Percentage Change in Measure of FLT Flux|The percentage change in the kinetic model parameter of FLT flux (Ki) was recorded. Ki is estimated from parameters derived by fitting the FLT input function and the total blood activity curve to the tissue time-activity curve data.|Baseline to up to 1 year after completion of treatment|4 patients had 2 scans, 2 patients had 3 scans|||percent change||Full Range|Median
2600093|NCT02167139|Secondary|Disease Activity Score Based on a 28 Joint Count (DAS28)||Week 24, Week 52|||||||
2600094|NCT02167139|Secondary|American College of Rheumatology 50% Response Criteria (ACR50)||Week 24, Week 52||||percentage of participants|||Number
2600095|NCT02167139|Secondary|ACR20||Week 52||||percentage of participants|||Number
2600096|NCT02167139|Primary|American College of Rheumatology 20% Response Criteria (ACR20)||Week 24||||percentage of participants|||Number
2600097|NCT02167074|Secondary|On-site Pathological Evaluation Performed|Presence of pathologist on site during procedure|27 months||||participants|||Number
2600098|NCT02167074|Secondary|Diagnostic Yield of the First Needle Pass|Yield is expressed as sample sufficiency for diagnostic analysis by pathologists, this was either sufficient or not|after 27 months|Yield is expressed as sample sufficiency for diagnostic analysis by pathologists, this was either sufficient or not|||Participants|||Count of Participants
2600102|NCT02167074|Primary|Diagnostic Accuracy|"Diagnostic accuracy is the number of correctly diagnosed cases as compared to gold standard diagnosis~Gold standard diagnosis is defined as;~in operated patients; based on the surgical resection specimen~in non-operated patients; based on the conclusions of the diagnostic work-up (combined outcomes of tissue sampling and imaging studies), and confirmed by a compatible clinical disease course of at least 9 months"|27 months||||Participants|||Count of Participants
2600103|NCT02167035|Secondary|Ocular Symptom and Tolerability Questionaire|The secondary endpoint of this study was to determine the tolerability of each treatment group by utilizing ocular symptom questionnaires administered at each study visit. These questionnaires assessed Oral effects (bad taste, dry mouth) and Ocular comfort effects (itching, burning, stinging, burning on instillation, blurred vision). The scale proved was none=0, mild=1, moderate=2, severe=3.|Baseline (Day 0), Visit 2 (Day 7), Visit 3 (Day 30), Visit 4 (Day 90)|Secondary endpoint analysis was conducted on the modified intent-to-treat (mITT) population, which consisted of all enrolled subjects randomized to masked study medication and who attended Visits 1,2,and 3 (minimally).|||units on a scale||Standard Deviation|Mean
2600104|NCT02167035|Primary|Intraocular Pressure|The Intraocular Pressure will be assessed on study subjects. IOP (Intraocular Pressure) will be measured using a Goldmann applanation tonometer. Both eyes will be tested, with the right eye preceding the left eye. The operator will initially set the dial at 10 mmHg, then look through the slit lamp and adjust the dial to take the reading, and then record the results. The procedure will be repeated on the same eye twice consecutively. If the measurements are within 2mmHg or less of each other, the mean of the 2 reading will be reported as the IOP at that time point. If the 2 reading are more than 2mmHg apart from each other, a third (consecutive) reading will be taken and the median (middle) IOP will be reported as the IOP at that time point. Preferable, the same operator will measure IOP and the same tonometer will be used at each visit.|Day 0 (08:00, 10:00 16:00), Day 30 (08:00, 10:00, 16:00), Day 90 (08:00, 10:00,16:00)|Primary endpoint analysis was conducted on the modified intent-to-treat (mITT) population, which consisted of all enrolled subjects randomized to masked study medication and who attended Visits 1,2,and 3 (minimally).|||mmHg||Standard Deviation|Mean
2600105|NCT02166697|Secondary|Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities + Lipid Abnormalities|Participants reporting cerebrovascular/cardiovascular events who had obesity, blood glucose and lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).|Baseline up to 3 years|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||Number of events/1,000 person-years|||Number
2600106|NCT02166697|Secondary|Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity + Blood Glucose Abnormalities, Obesity + Lipid Abnormalities, or Blood Glucose Abnormalities + Lipid Abnormalities|Participants reporting cerebrovascular/cardiovascular events who had multiple underlying risk factors which included either obesity + blood glucose abnormalities, obesity + lipid abnormalities OR blood glucose + lipid abnormalities associated with Blopress at the time of enrollment were reported. The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).|Baseline up to 3 years|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||Number of events/1,000 person-years|||Number
2600107|NCT02166697|Secondary|Incidence of Cerebrovascular/Cardiovascular Events Affected by Underlying Risk Factors of Obesity, Blood Glucose Abnormalities, or Lipid Abnormalities|Participants reporting cerebrovascular/cardiovascular events who had either obesity, blood glucose abnormalities, or lipid abnormalities as any one of the underlying risk factors associated with Blopress at the time of enrollment were reported.The composite events classified under primary MACE1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).|Baseline up to 3 years|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||Number of events/1,000 person-years|||Number
2600108|NCT02166697|Secondary|Incidence of Cerebrovascular/Cardiovascular Events|Cerebrovascular/cardiovascular events reported to be associated with Blopress were reported. The composite events classified under primary major adverse cardiac Events (MACE) 1 and primary MACE2 were defined as: MACE1: sudden death, cerebral hemorrhage, cerebral infarction, subarachnoid hemorrhage, and acute myocardial infarction; MACE2: MACE1 + hospitalization for cardiac failure and intervention/hospitalization for angina pectoris. Renal events include (transition to dialysis + renal transplant).|Baseline up to 3 years|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||Number of events per 1,000 person-years|||Number
2600109|NCT02166697|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions (SADR)|SADR are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 3 years|The safety analysis set was defined as all participants who were enrolled and completed the study.|||Participants|||Number
2600136|NCT02165904|Primary|Efficacy-Changes in the Neurophysiological Parameters (SSEPs, Somatosensory Evoked Potentials)|Changes in the neurophysiological parameters (SSEPs, somatosensory evoked potentials) measured as the number of patients that improved along the study.|Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery||||number of patients improved in SSEPs|||Number
2600110|NCT02166697|Primary|Number of Participants Reporting One or More Adverse Drug Reactions (ADR)|ADR are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 3 years|The safety analysis set was defined as all participants who were enrolled and completed the study.|||Participants|||Number
2600111|NCT02166606|Other Pre-specified|MRI Procedures Through 12 Months Post-Implant|The percentage of subjects who underwent an MRI scan through 12 months post-implant.|365 calendar days post implant||||Percentage of subjects with MRI Scan|||Number
2600112|NCT02166606|Primary|Percentage of Leads Free From Complication|Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead.|91 calendar days post-implant||||percentage of leads complication-free||95% Confidence Interval|Mean
2600113|NCT02166476|Secondary|Pharmacokinetic (PK) Characterization Of Plasma Exposure Of Meropenem/Vaborbactam|"This outcome measure focused on PK assessment of participants in the meropenem/vaborbactam group who met MITT criteria and had at least 1 plasma PK sample drawn. Sparse PK sampling on Day 1 was performed 3-3.5 hours and 5-6 hours after the start of the first 3-h IV study drug infusion. Samples were not collected around the 30-minute infusions. Samples were collected from both groups to maintain the blind; however, only PK samples for the meropenem/vaborbactam group were analyzed. The area under the curve (AUC) was generated using a Population PK model and post hoc estimates of each participants' PK parameters, including AUC0-24, were generated.~The AUC during 24 hours (AUC0-24) for Day 1 and at steady-state are presented in micrograms (ug)·hour/mL."|Day 1|PK population: Participants in the MITT population (all participants screened, randomized, and received at least 1 dose of study drug) and had at least 1 plasma PK sample drawn. Due to renal impairment, 28 participants received a reduced dose of the study drug (1 g meropenem/1 g vaborbactam).|||ug·hour/mL||Standard Deviation|Mean
2600114|NCT02166476|Secondary|Per-Pathogen Microbiological Outcome (EMA) In The ME Population|This secondary outcome measure focused on the per-pathogen (E. cloacae, E. faecalis, E. coli, K. pneumoniae) microbiological outcome of Eradication in the ME population at 5 time points: Day 3, EOIVT, EOT, TOC, and LFU. Eradication was defined per the EMA criteria as a reduction in baseline bacterial pathogen(s) to <10^3 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|ME population: all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received <80% or >120% of expected IV doses; missed no more than 1 IV dose in the first 48 hours, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure.|||Participants|||Count of Participants
2600115|NCT02166476|Secondary|Per-Pathogen Microbiological Outcome (EMA) In The m-MITT Population|This secondary outcome measure focused on the per-pathogen (E. cloacae, E. faecalis, E. coli, K. pneumoniae) microbiological outcome of Eradication in the m-MITT population at 5 time points: Day 3, EOIVT, EOT, TOC, and LFU. Eradication was defined per the EMA criteria as a reduction in baseline bacterial pathogen(s) to <10^3 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures.|||Participants|||Count of Participants
2600116|NCT02166476|Secondary|Per-Pathogen Microbiological Outcome (FDA) In The ME Population|This secondary outcome measure focused on the per-pathogen (E. cloacae, E. faecalis, E. coli, K. pneumoniae) microbiological outcome of Eradication in the ME population at 5 time points: Day 3, EOIVT, EOT, TOC, and LFU. Eradication was defined per the FDA criteria as a reduction in baseline bacterial pathogen(s) to <10^4 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|ME population: all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received <80% or >120% of expected IV doses; missed no more than 1 IV dose in the first 48 hours, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure.|||Participants|||Count of Participants
2600117|NCT02166476|Secondary|Per-Pathogen Microbiological Outcome (FDA) In The m-MITT Population|This secondary outcome measure focused on the per-pathogen (Enterobacter cloacae [E. cloacae], Enterococcus faecalis [E. faecalis], Escherichia coli [E. coli], Klebsiella pneumoniae [K. pneumoniae]) microbiological outcome of Eradication in the m-MITT population at 5 time points: Day 3, EOIVT, EOT, TOC, and LFU. Eradication was defined per the FDA criteria as a reduction in baseline bacterial pathogen(s) to <10^4 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures.|||Participants|||Count of Participants
2600134|NCT02165904|Primary|Efficacy-Urodynamic Studies Bladder Compliance|"Urodynamic studies in terms of Bladder compliance. Bladder compliance is the result of a mathematical calculation of volume responsible for 1 cm H2O pressure rise measured during a cystometric filling~. It gives an indication on how the different mechanisms in the bladder wall react on stretching.~It is obvious that compliance figures can vary widely in groups which makes it difficult to define limits of normality."|measure before treatment (baseline visit), 6 and 12 months after surgery||||mL/cm H2O||Standard Deviation|Mean
2600135|NCT02165904|Primary|Efficacy-Urodynammic in Terms of Detrusor Pressure|Urodynamic studies in terms of detrusor pressure (decrease on detrusor pressure is considered a clinical improvement)|Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up||||cm/H2O||Standard Deviation|Mean
2600183|NCT02165462|Secondary|Weight of the Patients With Haemophilia|The weight were collected using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA)|Screening visit||||Kg||Standard Deviation|Mean
2600118|NCT02166476|Secondary|Proportion Of Participants With A Clinical Outcome Of Cure In The ME Population|This secondary outcome measure focused on a clinical outcome of Cure in the ME population. A clinical outcome of Cure was defined as the following: at EOIVT, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP; at EOT, TOC, and LFU, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP such that no further antimicrobial therapy was warranted. Symptom resolution did not necessarily include baseline symptoms associated with anatomic abnormalities that predisposed to cUTI, such as symptoms associated with the presence of an indwelling urinary catheter. The clinical outcome of Cure was reported only at the EOIVT, EOT, TOC, and LFU visits, and improvement was reported only at the Day 3, EOIVT, and EOT visits.|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|ME population: all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received <80% or >120% of expected IV doses; missed no more than 1 IV dose in the first 48 hours, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure.|||Participants|||Count of Participants
2600119|NCT02166476|Secondary|Proportion Of Participants With A Clinical Outcome Of Cure In The Clinical Evaluable (CE) Population|This secondary outcome measure focused on a clinical outcome of Cure in the CE population. A clinical outcome of Cure was defined as the following: at EOIVT, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP; at EOT, TOC, and LFU, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP such that no further antimicrobial therapy was warranted. Symptom resolution did not necessarily include baseline symptoms associated with anatomic abnormalities that predisposed to cUTI, such as symptoms associated with the presence of an indwelling urinary catheter. The clinical outcome of Cure was reported only at the EOIVT, EOT, TOC, and LFU visits, and improvement was reported only at the Day 3, EOIVT, and EOT visits.|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|CE population: all participants who received ≥1 dose of drug (MITT), had no key inclusion/exclusion criteria violations, had a clinical outcome (Cure, Improvement, Failure) at EOIVT, received 80-120% of expected IV doses, missed ≤1 IV dose in the first 48 hours, missed ≤2 consecutive IV doses overall, received ≥6 doses (Failure) or ≥9 doses (Cure).|||Participants|||Count of Participants
2600120|NCT02166476|Secondary|Proportion Of Participants With A Clinical Outcome Of Cure In The m-MITT Population|This secondary outcome measure focused on a clinical outcome of Cure in the m-MITT Population. A clinical outcome of Cure was defined as the following: at EOIVT, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP; at EOT, TOC, and LFU, the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP such that no further antimicrobial therapy was warranted. Symptom resolution did not necessarily include baseline symptoms associated with anatomic abnormalities that predisposed to cUTI, such as symptoms associated with the presence of an indwelling urinary catheter. The clinical outcome of Cure was reported only at the EOIVT, EOT, TOC, and LFU visits, and improvement was reported only at Day 3, EOIVT, and EOT visits.|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures.|||Participants|||Count of Participants
2600121|NCT02166476|Secondary|Proportion Of Participants In The ME Population Who Achieved A Microbiologic Outcome Of Eradication|This secondary outcome measure focused on a microbiological outcome of Eradication in the ME population at 5 time points: Day 3, EOIVT, EOT, TOC, and LFU. Eradication was defined as a reduction in baseline bacterial pathogen(s) to <10^4 CFU/mL of urine culture (FDA) or <10^3 CFU/mL (EMA), and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|ME population: all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received <80% or >120% of expected IV doses; missed no more than 1 IV dose in the first 48 hours, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure.|||Participants|||Count of Participants
2600122|NCT02166476|Secondary|Proportion Of Participants In The m-MITT Population Who Achieved A Microbiologic Outcome Of Eradication|This secondary outcome measure focused on a microbiological outcome of Eradication in the m-MITT population at 5 time points: Day 3, EOIVT, end of treatment (EOT), TOC, and late follow up (LFU). Eradication was defined as a reduction in baseline bacterial pathogen(s) to <10^4 CFU/mL of urine culture (FDA) or <10^3 CFU/mL (EMA), and a negative blood culture for an organism that was identified as a uropathogen (if repeated after positive at baseline blood culture).|Day 3, EOIVT (Days 5-14), EOT (Days 10-14), TOC (Days 15-23), and LFU (Days 22-30)|The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures.|||Participants|||Count of Participants
2600123|NCT02166476|Secondary|Proportion Of Participants In The ME Population With Overall Success|This secondary outcome measure focused on the overall success in the ME population at the EOIVT and TOC visits. Overall success was defined as a clinical outcome of Cured or Improvement and a microbiologic outcome of Eradication. Cured was defined as the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP. Improvement was defined as lessening, incomplete resolution, or no worsening of the baseline signs and symptoms of cUTI or AP, but continued IV therapy was warranted. Eradication was defined using the FDA's CFU/mL criteria that the bacterial pathogen(s) found at baseline was/were reduced to <10^4 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|EOIVT (Days 5-14) and TOC (Days 15-23)|ME population: all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received <80% or >120% of expected IV doses; missed no more than 1 IV dose in the first 48 hours, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure.|||Participants|||Count of Participants
2600203|NCT02165124|Other Pre-specified|Blood Pressure|Unit of Measure: mmHg|12 Months|||||||
2600124|NCT02166476|Secondary|Proportion Of Participants In The m-MITT Population With Overall Success|This secondary outcome measure focused on the overall success in the ME population at the EOIVT and TOC visits. Overall success at TOC was defined as a clinical outcome of Cured and a microbiologic outcome of Eradication. Overall success at EOIVT was defined as a clinical outcome of Cured or Improvement and a microbiologic outcome of Eradication. Cured was defined as the complete resolution or significant improvement of the baseline signs and symptoms of cUTI or AP. Improvement was defined as lessening, incomplete resolution, or no worsening of the baseline signs and symptoms of cUTI or AP, but continued IV therapy was warranted. Eradication was defined using the FDA's CFU/mL criteria that the bacterial pathogen(s) found at baseline was/were reduced to <10^4 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|EOIVT (Days 5-14) and TOC (Days 15-23)|The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures.|||Participants|||Count of Participants
2600125|NCT02166476|Primary|Proportion Of Participants In The Microbiological Evaluable (ME) Population Who Achieved A Microbiologic Outcome Of Eradication At The TOC Visit|This was the primary outcome measure for the EMA. For this measure, a microbiologic outcome of Eradication was defined using the EMA's CFU/mL criteria: bacterial pathogen(s) found at baseline was reduced to <10^3 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture). The ME population included all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received <80% or >120% of expected IV doses; missed no more than 1 IV dose in the first 48 hours, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure.|TOC (Days 15-23)|ME population: all participants who met m-MITT criteria and had a clinical outcome and microbiologic outcome at EOIVT or earlier; received <80% or >120% of expected IV doses; missed no more than 1 IV dose in the first 48 hours, missed no more than 2 consecutive IV doses; received no less than 6 doses for failure or no less than 9 doses for cure.|||Participants|||Count of Participants
2600126|NCT02166476|Primary|Proportion Of Participants In The m-MITT Population Who Achieved A Microbiologic Outcome Of Eradication At The Test Of Cure Visit|This was the primary outcome measure for the European Medicines Agency (EMA). For this measure, a microbiologic outcome of Eradication was defined using the EMA's CFU/mL criteria: bacterial pathogen(s) found at baseline was reduced to <10^3 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|Test of cure (TOC) (Days 15-23)|The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures.|||Participants|||Count of Participants
2600127|NCT02166476|Primary|Proportion Of Participants In The Microbiological Modified Intent-To-Treat (m-MITT) Population Who Achieved Overall Success At The End Of Intravenous Treatment Visit|This was the primary outcome measure for the Food and Drug Administration (FDA). For this composite outcome measure, overall success was achieved with a clinical outcome of Cure or Improvement and microbiologic outcome of Eradication at the end of intravenous treatment (EOIVT). Cure was defined as the complete resolution or significant improvement of the baseline signs and symptoms. Improvement was defined as lessening, incomplete resolution, or no worsening of the baseline signs and symptoms. Eradication was defined using the FDA's colony-forming units (CFU)/mL criteria that the bacterial pathogen(s) found at baseline was/were reduced to <10^4 CFU/mL of urine culture and a negative blood culture for an organism that was identified as an uropathogen (if repeated after positive at baseline blood culture).|EOIVT (Days 5-14)|The m-MITT population included all participants who were randomized, received at least 1 dose of study drug, and had a baseline bacterial pathogen(s) of ≥10^5 CFU/mL of urine at baseline urine culture or the same bacterial pathogen present in concurrent blood and urine cultures.|||Participants|||Count of Participants
2600128|NCT02166346|Secondary|Upper and Lower Extremity Muscle Strength Measurements|Upper and lower extremity muscle strength measurements, using a hand held dynamometer, at the beginning and end of each arm. Change in muscle strength between baseline and end (8 weeks) of each intervention are provided.|baseline and end (8 weeks) of each intervention||||Pounds||95% Confidence Interval|Mean
2600129|NCT02166346|Primary|Walking Speed During Timed 25-foot Walk|In this cross-over study, walking speed was recorded 4 times for each subject while in both the dalfampridine and placebo arms. The results average all of the times while on damfampridine and compares them to the average of the times while on placebo.|Every 2 weeks during each 8 week intervention|In this cross-over study, walking speed was recorded 4 times for each subject while in both the dalfampridine and placebo arms. The results average all of the times while on damfampridine and compares them to the average of the times while on placebo.|||feet/second||Full Range|Mean
2600130|NCT02165904|Secondary|Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples|Changes in expression of neurotrophins in CSF (CerebroSpinal Fluid) samples obtained previously to first administration of cell therapy, and previously to the last administration, at month 10, in order to study the variability in the expression of neurotrophins along time. The mean+SD (standard deviation) at each time point was obtained. The tested neurotrophins were: BDNF.|Basal and 10 months after the administration||||pg/ml||Standard Deviation|Mean
2600131|NCT02165904|Secondary|Number of Adverse Events .|- The safety will be valued with number of adverse events related with administration of subarachnoid autologous Bone Marrow Expanded Mesenchymal Cells in Incomplete Spinal Cord Injury (SCI).|Up to 12 months||||Adverse events|||Number
2600132|NCT02165904|Primary|Efficacy-modification of Magnetic Resonance Imaging (MRI)|Number of patients with changes in morphology of injury compared with basal images|before (baseline visit) and at 12 months||||number of patients|||Number
2600133|NCT02165904|Primary|Efficacy-Urodynamic Studies Maximum Cystometric Capacity|Urodynamic studies in terms of Maximum cystometric capacity|Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up||||mL||Standard Deviation|Mean
2600720|NCT02159079|Secondary|In-hospital Mortality to Day 14|A secondary outcome will be in-hospital mortality to day 14 (defined as the incidence of mortality prior to hospital discharge within 14 days after enrollment).|14 days||||Participants|||Count of Participants
2600137|NCT02165904|Primary|Efficacy- Changes in NBD Score|"changes in NBD score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)~Ranges score: 0 to 47. 0-6 is very minor dysfunction. 7-9 is minor dysfunction. 10-13 is moderate dysfunction; and 14 or more is severe dysfunction."|measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery||||score on a scale||Standard Deviation|Mean
2600138|NCT02165904|Primary|Efficacy- Changes in Geffner Score|"changes in Geffner score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)~Ranges score: 0 to 6. Being 0 absence of bladder control and 6 total control of bladder"|Changes in Geffner scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)||||score on a scale||Standard Deviation|Mean
2600139|NCT02165904|Primary|Efficacy-Changes in EVA Score|"• Changes in EVA score at the beginning, through and the end of the treatment~Ranges score: 0 to 10. Being 0 absence of pain and 10 the worst pain."|measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery||||score on a scale||Standard Deviation|Mean
2600140|NCT02165904|Primary|Changes in ASHWORTH Score|"- Changes in ASHWORTH score at the beginning, through and the end of the treatment~Ranges score: 0 to 4. Being 0 when there isn´t increase in muscle tone when stretching, and 4 when there is rigid affected follow-up in flexion or extension"|measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery||||score on a scale||Standard Deviation|Mean
2600141|NCT02165904|Primary|Efficacy-Changes in PENN Score.|"- Changes in PENN score at the beginning, through and the end of the treatment~Ranges score: 0 to 4. Being 0 absence of spasms and 4 frequency greater than 10 spasms per hour."|measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery||||score on a scale||Standard Deviation|Mean
2600142|NCT02165904|Primary|Efficacy-IANC-SCIFRS Scale|"-Changes in IANC-SCIFRS scale~Ranges score: 0 to 48. Being 0 severe degree of disability and 48 normal value."|Changes in IANC-SCIFRS scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)||||score on a scale||Standard Deviation|Mean
2600143|NCT02165904|Primary|Efficacy-Change in Barthel Score|"- Changes in Barthel score at the beginning, through and the end of the treatment.~Ranges score: 0 to 100. Being 0 total patient dependency and 100 total patient independence."|measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery||||score on a scale||Standard Deviation|Mean
2600144|NCT02165904|Primary|Efficacy- Changes in Functional Independence Measure Scale|"- Changes in Functional Independence Measure scale (NIF scale), score at the beginning, through and the end of the treatment.~Ranges score: 18 to 126. Being 18 total patient dependency and 126 total patient independence."|measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery||||score on a scale||Standard Deviation|Mean
2600145|NCT02165904|Primary|Efficacy-Sensivity Improvement Using the ASIA Score|Sensitivity improvement was measured using the ASIA (American Spinal Injury Association) scale to measure the Surface sensitivity (LTS), pain sensitivity (PPS), and the degree of motor function in key muscles (MS). The sum of MS, LTS, and PPS configure total ASIA score. A minimum possible score is 0 points. A maximum possible score is 224 points for a patient with normal sensation. ASIA score was obtained before surgery, and 3, 6, 9 and 12 months after surgery. Mean and standard deviation for the 10 patients were obtained at all the time points and statistically analyzed.|measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery||||units on a scale||Standard Deviation|Mean
2600146|NCT02165826|Secondary|Median Simulated Absolute Change From Baseline in FEV1 at Weeks 4 and 12|The PK model predicted the total PDE4 inhibitory activity and the median simulated Change from Baseline (CFB) in FEV1 at Week 4 and the Change from Baseline in FEV1 at Week 12 during 12 weeks of treatment with roflumilast 500 μg OD based on 1000 participants simulated. Results are reported for the set of reference participants defined according to the covariates [weight, smoking status, sex, age, race, COPD severity, concomitant long acting muscarinic antagonist (LAMA) and Percent FEV1 reversibility] included in the final model and tPDE4i. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry prior to taking study medication. A positive change from Baseline indicates improvement.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours post-dose at Days 15 and 57. FEV-1: Pre-dose and Weeks 4 and 12|Pharmacokinetic (PK) Set included all participants who had at least 1 quantifiable PK concentration. The number of participants analyzed is the number of participants simulated. Measured values are predicted values.|||milliliters (mL)|||Number
2600147|NCT02165826|Secondary|Median Simulated Percentage of Participants With Adverse Events of Interest|The PK model predicted the total PDE4 inhibitory activity and the median simulated percentage of participants with Adverse Events of Interest during 12 weeks of treatment based on 1000 participants simulated. Results are reported for the set of reference participants defined according to the covariates [weight, smoking status, sex, age and long acting muscarinic antagonist (LAMA)] included in the final model and tPDE4i. Adverse Events of Interest (AEI) for PK analyses included: headache, diarrhea, nausea, vomiting, abdominal pain, appetite disorders, sleep disorders, angioedema, psychiatric disorders (anxiety, nervousness), psychiatric disorders (depression, suicidal ideation, behaviour) and weight loss.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours post-dose at Days 15 and 57. AEIs: 12 Weeks|Pharmacokinetic (PK) Set included all participants who had at least 1 quantifiable PK concentration. Number of participants analyzed is the number of participants simulated. Measured values are predicted values.|||percentage of participants|||Number
2600157|NCT02165826|Secondary|Change From Baseline in Pre-bronchodilator Forced Vital Capacity (FVC) During the Main Period|Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using spirometry prior to taking study medication. A positive change from Baseline indicates improvement.|Baseline (Day 1 of Main Period) to Days 15, 29, 57 and 84 (Main Period)|"Main Period FAS included all randomized participants, regardless of whether they took study medication. n in each of the categories is the number of participants with data available at the given time-point."|||Liters||Standard Deviation|Mean
2600168|NCT02165735|Secondary|Change in Undetectable Viral Load|Our seventh secondary outcome measure is undetectable viral load based on changes to participants' HIV viral load. The HIV viral load measurements were abstracted from the participants' personal health record (PHR). In our study, people who had a HIV viral load of <50 were considered to have undetectable viral load.|Baseline and 1 year|Multiple imputation was used to account for those with missing or incomplete data.|||percentage of participants||Standard Deviation|Mean
2600148|NCT02165826|Secondary|Summary Statistics of Predicted Total PDE4 Inhibitory Activity (tPDE4i)|tPDE4i was derived using in-vitro constants for protein binding and biochemical activity (IC50). An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Adverse Events of Interest (AEI) for PK analyses included: headache, diarrhea, nausea, vomiting, abdominal pain, appetite disorders, sleep disorders, angioedema, psychiatric disorders (anxiety, nervousness), psychiatric disorders (depression,suicidal ideation,behaviour) and weight loss.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours post-dose at Days 15 and 57. Down-titration: Pre-dose and 1,2,3,4,6 hours post-dose at Days 1 and 14 and pre-dose at Days 28 and 56.|"PK Set included all participants who had at least 1 quantifiable PK concentration. n in the category is the number of participants with available data. Study design only includes the 250 µg OD and 500 µg OD arms for analyses of this outcome measure. Measured values are predicted values reported as median and 90% prediction interval."|||unitless||90% Confidence Interval|Median
2600149|NCT02165826|Secondary|Total PDE4 Inhibitory Activity (tPDE4i)|tPDE4i was derived using in-vitro constants for protein binding and biochemical activity (IC50). tPDE4i is reported for a set of reference participants defined according to the covariates included in the final model.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours post-dose at Days 15 and 57. Down-titration: Pre-dose and 1,2,3,4,6 hours post-dose at Days 1 and 14 and pre-dose at Days 28 and 56.|Participants from the PK Set, all participants who had at least 1 quantifiable PK concentration, with data available. Study design only includes the 250 µg arm for analyses of this outcome measure in the Down-Titration period. Measured values are predicted values reported as median and 90% prediction interval.|||unitless||90% Confidence Interval|Median
2600150|NCT02165826|Secondary|Population PK Model Point Estimate for Apparent Peripheral Volume (Vp/F) of Roflumilast and Roflumilast N-oxide|PK model point estimates for Vp/F are calculated using all available PK data for all doses of roflumilast combined and are presented for roflumilast and metabolite roflumilast N-oxide. Results are reported for the subgroups defined according to the covariates (weight, age, smoking status and sex) included in the final model.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours at weeks 2 or 8|Pharmacokinetic (PK) Set included all participants who had at least 1 quantifiable PK concentration.|||L|||Number
2600151|NCT02165826|Secondary|Population PK Model Point Estimate for Apparent Central Volume (Vc/F) of Roflumilast and Roflumilast N-oxide|PK model point estimates for Vc/F are calculated using all available PK data for all doses of roflumilast combined and are presented for roflumilast and metabolite roflumilast N-oxide. Results are reported for the subgroups defined according to the covariates (weight, age, smoking status and sex) included in the final model.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours at weeks 2 or 8|Pharmacokinetic (PK) Set included all participants who had at least 1 quantifiable PK concentration.|||liters (L)|||Number
2600152|NCT02165826|Secondary|Population PK Model Point Estimate for Apparent Oral Clearance (CL/F) of Roflumilast and Roflumilast N-oxide|PK model point estimates for CL/F are calculated using all available PK data for all doses of roflumilast combined and are presented for roflumilast and metabolite roflumilast N-oxide. Results are reported for the subgroups defined according to the covariates (weight, age, smoking status and sex) included in the final model.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours at weeks 2 or 8|Pharmacokinetic (PK) Set included all participants who had at least 1 quantifiable PK concentration.|||liters per hour (L/h)|||Number
2600153|NCT02165826|Secondary|Population PK Model Point Estimate for Absorption Rate Constant (Ka) of Roflumilast and Roflumilast N-oxide|PK model point estimates for Ka are calculated using all available PK data for all doses of roflumilast combined and are presented for roflumilast and metabolite roflumilast N-oxide. Results are reported for the subgroups defined according to the covariates (weight, age, smoking status and sex) included in the final model.|Main period: Pre-dose and 1,2,3,4,6 hours post-dose or pre-dose and 2 hours at weeks 2 or 8|Pharmacokinetic (PK) Set included all participants who had at least 1 quantifiable PK concentration.|||units per hour (1/h)|||Number
2600154|NCT02165826|Secondary|Change From Baseline in Treatment Satisfaction Scores During the Down-Titration Period|Participants will be asked to assess their satisfaction with their COPD therapy at each visit. The participants will rate their treatment satisfaction on a 7-point scale where 0=very satisfied, 1=satisfied, 2=somewhat satisfied, 3=neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5=dissatisfied and 6=very dissatisfied. A negative change from Baseline indicates improvement.|Baseline DT (Day 1 of Down-Titration Period) to Days 14, 28 and 56 (Down-Titration Period)|"Down-Titration Period Full Analysis Set (FAS) included all randomized participants who entered this period, regardless of whether they took study medication. n in each of the categories is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2600155|NCT02165826|Secondary|Change From Baseline in Treatment Satisfaction Scores During the Main Period|Participants will be asked to assess their satisfaction with their COPD therapy at each visit. The participants will rate their treatment satisfaction on a 7-point scale where 0=very satisfied, 1=satisfied, 2=somewhat satisfied, 3=neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5=dissatisfied and 6=very dissatisfied. A negative change from Baseline indicates improvement.|Baseline (Day 1 of Main Period) to Days 15, 29, 57 and 84 (Main Period)|"Main Period FAS included all randomized participants, regardless of whether they took study medication. n in each of the categories is the number of participants with data available at the given time-point."|||score on a scale||Standard Deviation|Mean
2600156|NCT02165826|Secondary|Change From Baseline in Pre-bronchodilator Forced Vital Capacity (FVC) During the Down-Titration Period|Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using spirometry prior to taking study medication. A positive change from Baseline indicates improvement.|Baseline DT (Day 1 of Down-Titration Period) to Days 14, 28 and 56 (Down-Titration Period)|Down-Titration Period Full Analysis Set (FAS) included all randomized participants who entered this period, regardless of whether they took study medication.|||Liters||Standard Deviation|Mean
2600181|NCT02165462|Secondary|Joint Bleeding Before the Assessment||Screening visit||||participants|||Number
2600158|NCT02165826|Secondary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) During the Main Period|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry prior to taking study medication. A positive change from Baseline indicates improvement.|Baseline (Day 1 of Main Period) to Days 15, 29, 57 and 84 (Main Period)|"Main Period FAS included all randomized participants, regardless of whether they took study medication. n in each of the categories is the number of participants with data available at the given time-point."|||Liters||Standard Deviation|Mean
2600159|NCT02165826|Secondary|Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) During the Down-Titration Period|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry prior to taking study medication. A positive change from Baseline indicates improvement.|Baseline DT (Day 1 of Down-Titration Period) to Days 14, 28 and 56 (Down-Titration Period)|"Down-Titration Period Full Analysis Set (FAS) included all randomized participants who entered this period, regardless of whether they took study medication. n in each category is the number of participants with data available at the given time-point."|||Liters||Standard Deviation|Mean
2600160|NCT02165826|Secondary|Percentage of Participants Prematurely Discontinuing Study Treatment Due to Any Reason During Down-Titration Period||Baseline DT (Day 1 of Down-Titration Period) to Week 8 (Down-Titration Period)|Down-Titration Period Full Analysis Set (FAS) included all randomized participants who entered this period, regardless of whether they took study medication.|||percentage of participants|||Number
2600161|NCT02165826|Secondary|Change From Baseline (V0DT) in Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) to Final Visit of the Down-Titration Period|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry prior to taking study medication A positive change from Baseline indicates improvement.|Baseline (V0DT) [assessment at end of main period] and Final Visit of Down-Titration Period (Up to Day 56)|Participants from the Down-Titration Period Full Analysis Set (FAS), all randomized participants who entered this period, regardless of whether they took study medication, with data available for analysis.|||Liters||Standard Deviation|Mean
2600162|NCT02165826|Secondary|Percentage of Participants With Adverse Events of Interest|Adverse events of interest to evaluate tolerability are defined as diarrhea, nausea, headache, decreased appetite, insomnia and abdominal pain.|Baseline to Week 12 (Main Period)|SAS included all randomized participants who took at least one dose of study medication.|||percentage of participants|||Number
2600163|NCT02165826|Primary|Percentage of Participants Prematurely Discontinuing Study Treatment Due to Any Reason|The primary endpoint is the percentage of participants prematurely discontinuing study treatment for any reason during the Main Period from Visit 1 (V1) to Last Visit (Vend). Discontinuation is defined as permanently stopping randomized treatment; participants who resume randomized treatment after an interval will not be counted as having discontinued. The analysis used discontinuations occurring during the Main Period, irrespective of whether a participant subsequently entered into the Down-Titration Period.|Baseline to Week 12 (Main Period)|Safety Analysis Set (SAS) included all randomized participants who took at least one dose of study medication.|||percentage of participants|||Number
2600164|NCT02165761|Primary|Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points|Antibody screening was performed using a commercial poly-specific EIA that detects antibodies of any of the IgG, IgA, and / or IgM classes against PF4/polyvinyl sulfonate complexes, the EIA-GAM.|14 days after index procedure|"In the GORE® Hybrid Vascular Graft Group 19 out of 23 participants had obtained a serology sample at Day 7 and/or Day 14 for analysis.~In the Non-heparin bonded synthetic graft Group 16 out of 19 participants had obtained a serology sample at Day 7 and/or Day 14 for analysis."|||Participants|||Count of Participants
2600165|NCT02165735|Secondary|Change in Short Form Health Survey: [Physical Health] (SF12)|Our final secondary outcome measure is physical well-being and quality of life based on changes on the Short Form Health Survey or SF12. The Short Form Health Survey (SF12) is a 12-item measure with 6 items that assesses patient mental well-being/quality of life and 6 items that assesses patient physical well-being/quality of life. People who score high on the SF-12 are normally in good mental and physical health. The scores for the 12-item measure includes two scales whose range in value from 0-100, with higher scores indicating a better health state.|Baseline and 1 year|Multiple imputation was used to account for those with missing or incomplete data.|||score on a scale||Standard Deviation|Mean
2600166|NCT02165735|Secondary|Change in Short Form Health Survey: [Mental Health] (SF12)|Our ninth secondary outcome measure is mental well-being and quality of life based on changes on the Short Form Health Survey or SF12. The Short Form Health Survey (SF12) is a 12-item measure with 6 items that assesses patient mental well-being/quality of life and 6 items that assesses patient physical well-being/quality of life. People who score high on the SF-12 are normally in good mental and physical health. The scores for the 12-item measure includes two scales whose range in value from 0-100, with higher scores indicating a better health state.|Baseline and 1 year|Multiple imputation was used to account for those with missing or incomplete data.|||score on a scale||Standard Deviation|Mean
2600167|NCT02165735|Secondary|Change in Evidence-based Preventative Care|Our eighth secondary outcome measure is prevention-seeking behavior based on chart abstracted information based on our preventive care index. We created a preventive care index for each participant by assigning one point of each intervention they received post-randomization divided by the total number of interventions for which they were eligible. The index included eleven preventive care measures: Human Papillomavirus, Influenza, Tetanus, Hepatitis A, B, C testing, Hepatitis A & B vaccinations, cervical cancer screening (PAP), mammography and any colon cancer screening. People who score high on the evidence-based preventative care normally are more able to prevent illnesses or diseases. The score for the measure range in value from 0-1, with higher scores indicating greater ability to stay healthy.|Baseline and 1 year|Multiple imputation was used to account for those with missing or incomplete data.|||score on a scale||Standard Deviation|Mean
2600182|NCT02165462|Secondary|Diagnosis, Severity of Hemophilia, Treatment (Prophylactic or on Demand)|Patients fill out a registration key clinical data (type, severity of hemophilia, hemarthrosis in the previous month and current drug therapy).|Screening visit||||participants|||Number
2600169|NCT02165735|Secondary|Change in Self-Reported Adherence|Our sixth secondary outcome measure is adherence to combination antiretroviral treatment (cART) based on changes on survey of recommended items for assessing self-reported antiretroviral adherence. Our survey included two recommended assessment items with the focus on one-item measure that assesses patient self-reported adherence to taking HIV medications. People who score high on the self-reported adherence cART normally are very confident of being more adherent to taking their HIV medications. The score for the one-item measure range in value from 0-100 percent, with higher scores indicating greater adherence to cART.|Baseline and 1 year|Multiple imputation was used to account for those with missing or incomplete data.|||percentage of cART adherence in past mth||Standard Deviation|Mean
2600170|NCT02165735|Secondary|Change in HIV Adherence Self-Efficacy Scale (ASES)|Our fifth secondary outcome measure is HIV adherence self-efficacy based on changes in the HIV Adherence Self-Efficacy Scale or ASES. The HIV Adherence Self-Efficacy Scale (ASES) is a 15-item measure that assesses patient self-efficacy for adherence to HIV treatment plan including but not limited to taking HIV medications. People who score high on the ASES normally are very confident of sticking to their HIV treatment plan even when it is hard. The scores for the 15-item measure range in value from 0-150, with higher scores indicating greater adherence self-efficacy.|Baseline and 1 year|Multiple imputation was used to account for those with missing or incomplete data.|||score on a scale||Standard Deviation|Mean
2600171|NCT02165735|Secondary|Change in Instrument on Doctor Patient Communication Skills (IDPCS)|Our fourth secondary outcome measure is clinician patient centeredness based on changes in the Instrument on Doctor Patient Communication Skills or IDPCS. The Instrument on Doctor Patient Communication Skills (IDPCS) is a 19-item measure that assesses patient perception of the doctor's communication proficiency with them. People who score high on the IDPCS normally are satisfied with the way the doctor speak with them about their care. The scores for the 19-item measure range in value from 19-95, with higher scores indicating greater quality communication by the doctor.|Baseline and 1 year|Multiple imputation was used to account for those with missing or incomplete data.|||score on a scale||Standard Deviation|Mean
2600172|NCT02165735|Secondary|Change in Perceived Involvement in Care Scale (PICS)|Our third secondary outcome measure is involvement in care based on changes in the Perceived Involvement in Care Scale or PICS. The Perceived Involvement in Care Scale (PICS) is an 8-item measure that assesses patient perceived proficiency in communicating concerning their health care with the doctor. People who score high on the PICS normally are satisfied with how well they feel they communicate with the doctor about their care. The scores for the 8-item measure range in value from 8-40, with higher scores indicating greater perceived involvement in their care.|Baseline and 1 year|Multiple imputation was used to account for those with missing or incomplete data.|||score on a scale||Standard Deviation|Mean
2600173|NCT02165735|Secondary|Change in Decisional Self-Efficacy Scale (DSES)|Our next secondary outcome measure is decision making based on changes in the Decisional Self-Efficacy Scale or DSES. The Decisional Self-Efficacy Scale (DSES) is an 11-item measure that assesses patient confidence in their ability to make health care decisions. People who score high on the DSES normally have an easier time making health care decisions. The scores for the 11-item measure range in value from 0-100, with higher scores indicating greater confidence in making an informed choice.|Baseline and 1 year|Multiple imputation was used to account for those with missing or incomplete data.|||score on a scale||Standard Deviation|Mean
2600174|NCT02165735|Secondary|Change in eHealth Literacy Scale (eHEALS)|Our first secondary outcome measure is eHealth literacy based on changes in the eHealth Literacy Scale or eHEALS. The eHealth Literacy Scale (eHEALS) is an 8-item measure that assesses patient comfort, knowledge, and skills at finding health information on the internet and evaluating whether or not it is reliable. People who score high on the eHEALS normally are very comfortable finding reliable information on the internet. The scores for the 8-item measure range in value from 8-40, with higher scores indicating greater perceived skills at using online health information to help solve health problems.|Baseline and 1 year|Multiple imputation was used to account for those with missing or incomplete data.|||score on a scale||Standard Deviation|Mean
2600175|NCT02165735|Primary|Change in Patient Activation Measure (PAM)|"Our primary outcome measure is patient empowerment based on changes in the Patient Activation Measure or PAM. The Patient Activation Measure (PAM) is a 13-item measure that assesses patient knowledge, skill, and confidence for self-management. People who score high on the PAM normally understand the importance of taking an active role in managing their health and have the skills and confidence to do so.The scores for the 13-item measure range in value from 0-100, with higher scores indicating greater activation.~LEVEL 1 (0-47): May not yet believe that the patient role is important LEVEL 2 (47.1 - 55.1): Lacks confidence and knowledge to take action LEVEL 3 (55.2 - 67.0): Beginning to take action LEVEL 4 (67.1 - 100): Adapting new behaviors, but may have difficulty maintaining over time"|Baseline and 1 year|Multiple imputation was used to account for those with missing or incomplete data|||score on a scale||Standard Deviation|Mean
2600176|NCT02165722|Primary|Change in Percentage of Cumulative HPV Series Completion Vaccination Rates for Adolescents 11-17 Years of Age|Change in cumulative vaccination rates from baseline to end of year 1 for HPV series completion (e.g., receipt of third dose of HPV vaccine) stratified by age 11-13 years and 14-17 years. Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015.|Baseline period to post-intervention||||percent change in vaccination rates|||Number
2600177|NCT02165722|Primary|Change in Percentage of Cumulative HPV Series Initiation Vaccination Rates for Adolescents 11-17 Years of Age|Change in cumulative vaccination rates from baseline to end of year 1 for HPV series initiation (e.g., receipt of first dose of HPV vaccine) stratified by age 11-13 years and 14-17 years. Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015.|Baseline period to post-intervention|HPV series initiation stratified by age of 11-13 years and 14-17 years of age. Baseline period was 7/1/2013 to 6/30/2014. Intervention period was 7/1/2014 to 3/31/2015.|||percent change in vaccination rates|||Number
2600178|NCT02165462|Secondary|Age of Patients With Haemophilia||Screening visit||||years||Standard Deviation|Mean
2600179|NCT02165462|Secondary|Body Mass Index of Patients With Haemophilia|The body mass index of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA).|Screening visit||||kg/m2||Standard Deviation|Mean
2600180|NCT02165462|Secondary|Height of the Patients With Haemophilia|The height of patients was calculated using a TANITA equipment (TBF-300WA model, Tanita Corporation of America, Inc., Illinois, USA).|Screening visit||||cm||Standard Deviation|Mean
2600184|NCT02165462|Primary|Assessment of Maximal Velocity of Movement|Assessment of maximal velocity of movement with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|The maximum speed (Vmax) was calculated as the maximum value of the first integral of the force-time curve for bilateral contractions, left-sided and right-sided|||m/s||Standard Deviation|Mean
2600185|NCT02165462|Primary|Assessment of Rate of Development During the Acceleration Phase|Assessment of rate of development during the acceleration phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit||||N/s||Standard Deviation|Mean
2600186|NCT02165462|Primary|Change of Joint Condition Based on Clinical Assessment|"Spanish version of the Haemophilia Joint Health Score 2.1 (HJHS). Additive scale that assesses from 0 to 24 points joint status of patients with haemophilia (0: no joint damage; 24: maximum joint damage).~The variables studied in this scale are: Swelling (range 0-3); Duration of swelling (range 0-1); Muscle atrophy (range 0-2); Crepitant in motion (range 0-2); Loss of Flexion (range 0-3); Loss of extension (range 0-3); Joint pain (range 0-2): Strength (range 0-4); Gait (range 0-4)"|Screening visit||||Units on a scale (range 0-24)||Standard Deviation|Mean
2600187|NCT02165462|Primary|Assessment of Rate of Development During the Preparation Phase|Assessment of rate of development during the preparation phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit||||N/s||Standard Deviation|Mean
2600188|NCT02165462|Primary|Assessment of Maximal Peak Force|Assessment of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|The maximum peak force (MPF) is defined as the maximum achieved in the force-time curve during the dynamic test plantar flexion for both bilateral conditions as right and left unilateral, normalized to body weight of the participants (N / kg value)|||N/kg||Standard Deviation|Mean
2600189|NCT02165462|Primary|Assessment of Bilateral Index of Rate of Development During the Acceleration Phase|Assessment of bilateral index of rate of development during the acceleration phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|"Bilateral rates was calculated during the acceleration phase to express relative difference in strength between bilateral and unilateral conditions (calculated in percentages). Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is [100x (bilateral) / (right unilateral + left unilateral)] - 100"|||percentage||Standard Deviation|Mean
2600190|NCT02165462|Primary|Assessment of Bilateral Index of Rate of Development During the Preparation Phase|Assessment of Bilateral index of rate of development during the preparation phase with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)|Screening visit|"Bilateral rates was calculated during the preparation phase to express relative difference in strength between bilateral and unilateral conditions (calculated in percentages). Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is [100x (bilateral) / (right unilateral + left unilateral)] - 100"|||percentage||Standard Deviation|Mean
2600191|NCT02165462|Primary|Assessment of Bilateral Index of Maximal Peak Force|Assessment of bilateral index of maximal peak force with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA).|Screening visit|"Bilateral rates was calculated during the preparation phase and during the acceleration phase to express relative difference in strength between bilateral and unilateral conditions. Based on information in the Howard and Enoka (1991), the calculation detail for the Bilateral Index is [100x (bilateral) / (right unilateral + left unilateral)] - 100"|||percentage||Standard Deviation|Mean
2600192|NCT02165384|Primary|Number of Participants With Intra-operative Adverse Events|Any intra-operative adverse events, anticipated or unanticipated|Intra-operative||||Participants|||Count of Participants
2600193|NCT02165384|Primary|Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane|Success will be determined at the end of each ear tube procedure, by whether or not the TTS was used during the tympanostomy procedure to make an incision in the tympanic membrane and deploy an ear tube. Data may be presented when enrollment has been completed and all pre-operative and procedure data are analyzed.|intra operative|393 ears in 199 patients received ear tube placement from the Hummingbird device.|||Ears|Ears||Count of Units
2600194|NCT02165202|Primary|Number of Participants Experiencing Any Grade 2 or Higher AEs During Injection Phase|Number of participants experiencing any Grade 2 or higher clinical and laboratory AEs to evaluate the safety of the injectable product, TMC278 LA (1200 mg dose administered at Weeks 4, 12, 20, 28, 36 and 44), through 48 weeks after initial injection (at Week 52) in women in SSA and the US.|Up to 52 weeks|Participants who received at least one injection and were followed up to 52 weeks are included in this analysis.|||Participants|||Count of Participants
2600195|NCT02165124|Other Pre-specified|Gastric Motility/Emptying|"Unit of Measure: (t 1/2) in minutes, A gastric emptying scan (GES) is a nuclear medicine exam that uses a radioactive material that you will eat in a meal. You will eat this meal in the Radiology department before your scan. The radioactive material allows doctors to see how your stomach empties.~This scan is used to help diagnose conditions called motility disorders. These are conditions that change the way the stomach contracts and moves food into your intestines. A GES is a form of radiology, because radiation is used to take pictures of your body."|12 Months|||||||
2600196|NCT02165124|Other Pre-specified|Results From Endoscopy|Photos and clinical reports analyzed|12 Months|||||||
2600197|NCT02165124|Other Pre-specified|Food Intake|Documented via journal entries|12 Months|||||||
2600198|NCT02165124|Other Pre-specified|Quality of Life Parameters Survey|Unit of Measure: N/A Utilizing Short Form Health Survey (SF)-36 and Impact of Weight on Quality of Life (IWQOL)-Lite|12 Months|||||||
2600199|NCT02165124|Other Pre-specified|Eating and Hunger/Satiety Assessments|Unit of Measure: N/A Utilizing 3-Factor Eating Questionnaire Scores|12 Months|||||||
2600200|NCT02165124|Other Pre-specified|Serum Obesity Hormone(Leptin)|"This will be assessed by Leptin concentration~Unit of Measure: pg/mL, Leptin is a mediator of long-term regulation of energy balance, suppressing food intake and thereby inducing weight loss."|12 Months|||||||
2600201|NCT02165124|Other Pre-specified|Ghrelin Levels|Unit of Measure: pg/mL, Ghrelin on the other hand is a fast-acting hormone, seemingly playing a role in meal initiation.|12 Months|||||||
2600202|NCT02165124|Other Pre-specified|Lipid Panel|"Unit of Measure: mg/dL, Total cholesterol, High-density lipoprotein cholesterol (HDL-C) — often called good cholesterol , Low-density lipoprotein cholesterol (LDL-C) — often called bad cholesterol and Triglycerides"|12 Months|||||||
2600204|NCT02165124|Primary|Percent Weight Change|This will be assessed by Percentage of excess weight loss (EWL). Percentage of excess weight loss is calculated by measuring the participants excess weight at baseline and then calculating the percentage of excess weight that was lost 12 months after surgery (for example if a participant has 100 pounds of excess weight prior to surgery and loses 30 pounds, their excess weight loss would be 30%).|12 Months||||percentage of excess weight loss||Standard Deviation|Mean
2600205|NCT02165111|Secondary|Assessment of Raynaud's Symptom Severity Using the VAS for Pain.|A secondary outcome of this study is pain as measured by the validated visual-analog scale (VAS) for pain. The VAS pain instrument measures pain on a scale from 0 cm (no pain) to 10 cm (extreme pain)|Measured at one month post-injection.||||centimeters measured on a visual scale||Standard Deviation|Mean
2600206|NCT02165111|Secondary|Assessment of Raynaud's Symptom Severity Using the McCabe Cold Sensitivity Score.|A secondary outcome of this study is the patient-reported sensitivity to coldness as measured by the McCabe Cold Sensitivity score. Patients' answers on this validated instrument are scored on a scale from 0 (no sensitivity) to 400 (extreme sensitivity), where a higher number represents a worse outcome.|Measured at one month post-injection.||||Units on a scale||Standard Deviation|Mean
2600207|NCT02165111|Secondary|Assessment of Raynaud's Symptoms Severity Using the Quick-DASH Score.|A secondary outcome of this study is severity of Raynaud's symptoms as measured by the self-reported Quick-DASH score. The Quick-DASH scores measures the degree of hand and upper extremity function on a scale of 0 (not limited) to 100 (severely limited) where a higher value represents a worse outcome.|Measured at one month post-injection.||||Units on a scale||Standard Deviation|Mean
2600208|NCT02165111|Secondary|Number of Ulcers as Measure of Digital Ulcer Healing|A secondary outcome of this study is the number of digital ulcers as determined by clinical examination. Mean number of ulcers was calculated as total number of ulcers / total number of hands in each group.|Measured at one month post-injection.||||Number of ulcers||Standard Deviation|Mean
2600209|NCT02165111|Secondary|Rate of Change in Raynaud's Phenomenon Symptoms Measured With the Raynaud's Condition Score.|"Raynaud's Condition Score is a patient-reported, validated outcomes scale that measures the severity of Raynaud's phenomenon on a scale of 0 (No difficulty) to 10 (Extreme difficulty), where higher values represent a worse outcome.~Data from each weekly report were combined using a statistical model (generalized linear population-average model) to calculate a weekly rate of change for each participant's hand, where a negative value represents a improvement over time and a positive value represents worsening over time."|Weekly rate of change over the four-month study period.||||change in RCS/week||95% Confidence Interval|Mean
2600210|NCT02165111|Primary|Change in Digital Blood Flow From Pre- to Post-injection.|The primary outcome measure is change in blood flow to the fingers, from a pre-injection baseline to post-injection follow-up visit as measured by non-invasive laser Doppler imaging.|Measured pre-injection and at one month post-injection.||||Blood flow, measured in LDI flux units,||95% Confidence Interval|Mean
2600211|NCT02165072|Primary|Percent Collapse of the Inferior Vena Cava in Patients With Acute Kidney Injury|The investigators will measure the maximum and minimum diameters of the inferior vena cava with patients with acute kidney injury and calculate the percent change between the maximum and minimum diameters.|Day 1 of ICU admission||||Percent change||Standard Deviation|Mean
2600212|NCT02165072|Primary|Maximum and Minimum Diameters of the Inferior Vena Cava in Patients With Acute Kidney Injury|The investigators will measure the maximum and minimum diameters of the inferior vena cava with patients with acute kidney injury.|Day 1 of ICU admission||||cm||Standard Deviation|Mean
2600213|NCT02164981|Other Pre-specified|"Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI) - Percent of Participants Reporting Experiencing Symptoms at Moderate or Severe Level for the 10 Most Frequently Reported Symptoms Post Randomization"|The Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI): This is a self-rated 77-item questionnaire organized into 13 body areas assessing possible adverse events during the course of the trial.|Baseline (Day - 1), Follow-Up = reported at any assessment thereafter, including 7 hours after Infusions #1 and #2, Baseline 2 (Day 13) and final follow-up, including early termination visits.|Includes all subjects with SAFTEE data|||percentage of participants|||Number
2600214|NCT02164981|Other Pre-specified|Number of Subject Withdrawals Due to Treatment-Emergent Adverse Events (TEAEs)|Incidence of Treatment-Emergent Adverse Events (TEAE) by Treatment Group. A treatment emergent adverse event (TEAE) is an AE that either began following initiation of study treatment or was present prior to the initiation of the treatment, but increased in frequency or severity following initiation treatment, regardless of causality.|The period of observation extends from Day 0 treatment through the final visit at Day 28|All subjects withdrawn from the study due to TEAEs|||participants|||Number
2600215|NCT02164981|Other Pre-specified|Incidence of Treatment-Emergent Adverse Events (TEAEs)|Incidence of Treatment-Emergent Adverse Events (TEAE) by Treatment Group. A treatment emergent adverse event (TEAE) is an AE that either began following initiation of study treatment or was present prior to the initiation of the treatment, but increased in frequency or severity following initiation treatment, regardless of causality.|The period of observation for collection of treatment-emergent adverse events extends from Day 0 treatment through the final visit at Day 28.|Number of Treatment-Emergent Adverse Events (TEAEs) in Each Treatment Group|||# of TEAEs|||Number
2600216|NCT02164981|Other Pre-specified|ECG Measures at All Time Points by Group|Infusion 2 (Day 14) - ECG measures at all time points by group|Day 14 - Baseline (pre-infusion), During Infusion (@30 min), Post-Infusion (@60min)|All subjects receiving a complete or partial Phase 2 infusion|||mm/sec||Standard Deviation|Mean
2600217|NCT02164981|Other Pre-specified|ECG Measures at All Time Points by Group|Infusion 1 (Day 0) - ECG measures at all time points by group|Day 0 - Baseline (pre-infusion), During Infusion (@30 min), Post-Infusion (@60min)|All subjects receiving a complete or partial Phase 1 infusion|||mm/sec||Standard Deviation|Mean
2600218|NCT02164981|Other Pre-specified|Heart Rate Per Infusion Phase by Group|"Infusion 2 (Day 14) - Heart rate at all time points by group~Phase in this analysis refers to the infusion stage as defined in the protocol."|Day 14 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hours|Includes all subjects during Phase 1 (i.e., infusion 1)|||bpm||Standard Deviation|Mean
2613881|NCT02015754|Secondary|One-year Survival Percentage|Percentage of study patients surviving after one year from initial treatment analyzed with Kaplan-Meier curve.|1 year||||percentage of participants|||Number
2600219|NCT02164981|Other Pre-specified|Heart Rate Per Infusion Phase by Group|"Infusion 1 (Day 0) - Heart rate at all time points by group~Phase in this analysis refers to the infusion stage as defined in the protocol."|Day 0 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hours|Includes all subjects during Phase 1 (i.e., infusion 1)|||bpm||Standard Deviation|Mean
2600220|NCT02164981|Other Pre-specified|Phase 2 - Diastolic Blood Pressure Per Infusion Phase by Group|Infusion 2 (Day 14) - Diastolic Blood Pressure at all time points by group|Day 14 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hours|Includes all subjects during Phase 1 (i.e., infusion 1)|||mmHg||Standard Deviation|Mean
2600221|NCT02164981|Other Pre-specified|Systolic Blood Pressure Per Infusion Phase by Group|"Infusion 2 (Day 14) - Systolic Blood Pressure at all time points by group~Phase in this analysis refers to the infusion stage as defined in the protocol."|Day 14 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hours|Includes all subjects during Phase 2 (i.e., infusion 2)|||mmHg||Standard Deviation|Mean
2600222|NCT02164981|Other Pre-specified|Diastolic Blood Pressure Per Infusion Phase by Group|"Infusion 1 (Day 0) - Diastolic Blood Pressure at all time points by group~Phase in this analysis refers to the infusion stage as defined in the protocol."|Day 0 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hours|Includes all subjects during Phase 1 (i.e., infusion 1)|||mmHg||Standard Deviation|Mean
2600223|NCT02164981|Other Pre-specified|Systolic Blood Pressure Per Infusion Phase by Group|"Infusion 1 (Day 0) - Systolic Blood Pressure at all time points by group~Phase in this analysis refers to the infusion stage as defined in the protocol."|Day 0 - Phase 1 - Baseline = min000s1 and @5 min; Phase 2 - Baseline = min000 then every 10 minutes for 4 hours; Post Infusion - Baseline = min000, then every 10 minutes for 2 hours|Includes all subjects during Phase 1 (i.e., infusion 1)|||mmHg||Standard Deviation|Mean
2600224|NCT02164981|Other Pre-specified|Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS)|The Columbia Suicide Severity Rating Scale (C-SSRS): The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior that was developed in the National Institute of Mental Health Treatment of Adolescent Suicide Attempters Study to assess severity and track suicidal events through any treatment. It is a clinical interview providing a summary of both ideation and behavior that can be administered during any evaluation or risk assessment to identify the level and type of suicidality present. The C-SSRS can also be used during treatment to monitor for clinical worsening or improvement. It contains 5 rating scale questions (yes/no) for suicidal ideation increasing severity and 5 rating scale questions (yes/no) for suicidal behavior of increasing severity. The time frame is for both lifetime and the past six months for the Baseline/Screening scale and since the last visit for the Since Last Visit scale.|Screening Visit, Days 3 (Baseline 1), Days 7, 13 (Baseline 2), 21 and 28|All subjects with C-SSRS data reporting suicidal ideation/behavior|||Participants|||Count of Participants
2600225|NCT02164981|Other Pre-specified|Change in The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) - Phases 1 and 2|The University of California San Diego (UCSD) Performance-based Skills Assessment Brief (UPSA-B) consists of two of the five original UPSA domains, finances and communication. Each subscale contributes 50 points; total scores range from 0 to 100 points with higher scores reflecting better performance.|Phase 1 timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28|Ph1 analysis includes 34 subjects with Baseline UPSA-B data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 subjects the Drug-Drug group. Per SPCD, Ph 2 excludes the 18 subjects in the Drug-Drug group and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with Baseline UPSA-B data.|||units on a scale||Standard Deviation|Mean
2600226|NCT02164981|Other Pre-specified|"Percent of Participants Rated as ≥ Mild or as Yes on AIMS Items 8-12"|"Abnormal Involuntary Movement Scale (AIMS):~The AIMS is a 12-item anchored score that is clinician administered and scored. Items are scored on a 0 (none) to 4 (severe) basis; items 8-10 deal with global severity; items 11-12 are yes-no questions concerning problems with teeth and/or dentures."|Baseline (Day -1), Follow-Up = reported at any assessment thereafter, including 7 hours after Infusions #1 and #2, Baseline 2 (Day 13) and final follow-up, including early termination visits.|For each item, percentages of participants rated as exhibiting behaviors at the “mild” level or higher, or for items 11 and 12, as being present versus not (yes/no rated) are provided per treatment group.|||percentage of participants|||Number
2600227|NCT02164981|Other Pre-specified|Average AIMS Total Scores (Items 1-7) by Group and Timepoint|"Abnormal Involuntary Movement Scale (AIMS):~The AIMS Total Dyskinesia Score was calculated by averaging the first 7 items of the AIMS. The 7 items included in the AIMS Dyskinesia Score are rated on a scale from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score ranges from 0 to 4; a higher score reflects increased severity."|Baseline 1 (Day -1), 7 Hours Post-Infusion 1, Baseline 2 (Day 13), 7 Hours Post-Infusion 2, Final Follow-Up, including early termination visits|Includes all subjects with AIMS data at Phases 1 and 2|||units on a scale||Standard Deviation|Mean
2600228|NCT02164981|Other Pre-specified|Change in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) - Phases 1 and 2|MATRICS: The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB). The MATRICS Consensus Cognitive Battery is the standard tool for assessing cognitive change in trials of cognitive-enhancing agents in schizophrenia. The MCCB domains include: Speed of Processing; Attention/Vigilance; Working Memory; Verbal Learning; Visual Learning; Reasoning & Problem-Solving; and Social Cognition and the battery takes about 80 minutes to complete. The MCCB composite score represents a global measure of cognition. MCCB composite T scores are between 40 and 60 (normal range) and < 40 (below normal range).|Phase 1 timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28|Ph1 analysis includes 34 subjects with Baseline MATRICS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 subjects the Drug-Drug group. Per SPCD, Ph 2 excludes the 18 subjects in the Drug-Drug group and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with Baseline MATRICS data.|||T-scores||Standard Deviation|Mean
2600229|NCT02164981|Secondary|Average Percent Change From Baseline in the PANSS General Psychopathology Subscale Score After 2 Weeks of Treatment Using SPCD|The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. General Psychopathology subscore scale: 16 items (minimum score = 16; maximum score = 112)|For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28|Ph 1 analysis includes 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes 18 subjects in the Drug-Drug group and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.|||percent change||Standard Deviation|Mean
2600230|NCT02164981|Secondary|Average Percent Change From Baseline in the PANSS Negative Subscale Score After 2 Weeks of Treatment Using SPCD|The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Negative subscore scale: 7 items (minimum score = 7; maximum score = 49)|For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28|Phase 1 analysis combines the 34 subjects assigned to Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and the 18 subjects assigned to the Drug-Drug group with complete data at all visits. Per SPCD, the Phase 2 data includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with complete data at all visits.|||percent change||Standard Deviation|Mean
2600231|NCT02164981|Secondary|Average Percent Change From Baseline in the PANSS Positive Subscale Score After 2 Weeks of Treatment Using SPCD|The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Positive subscore scale: 7 items (minimum score = 7; maximum score = 49)|For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28|Ph 1 analysis includes 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes 18 subjects in the Drug-Drug group and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.|||percent change||Standard Deviation|Mean
2600232|NCT02164981|Secondary|Percentage of Subjects With 20% or More Reduction From Baseline in PANSS Total Score After 2 Weeks of Treatment Using SPCD|The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Total score minimum = 30, maximum = 210.|For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28|Phase 1 analysis combines the 34 subjects assigned to Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and the 18 subjects assigned to the Drug-Drug group with complete data at all visits. Per SPCD, the Phase 2 data includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with complete data at all visits.|||percent of subjects|||Number
2600233|NCT02164981|Secondary|Average Percent Change From Baseline in the PANSS Total Score After 2 Weeks of Treatment Using SPCD|The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Total score minimum = 30, maximum = 210.|For Phase 1, timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28|Ph 1 analysis includes 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes 18 subjects in the Drug-Drug group and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.|||percent change||Standard Deviation|Mean
2600234|NCT02164981|Secondary|PANSS - General Psychopathology Subscale - Phases 1 and 2|The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. General Psychopathology Subscale: 16 Items, (minimum score = 16, maximum score = 112)|Phase 1 timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28|Ph 1 analysis includes the 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes the 18 Drug-Drug group subjects and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.|||units on a scale||Standard Deviation|Mean
2600235|NCT02164981|Secondary|PANSS - Negative Subscale - Phases 1 and 2|The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Negative scale: 7 Items, (minimum score = 7, maximum score = 49)|Phase 1 timeframe is Day 0 and Day 14; Phase 2 timeframe is Day 14 and Day 28|Ph 1 analysis includes the 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes the 18 Drug-Drug group subjects and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.|||units on a scale||Standard Deviation|Mean
2600236|NCT02164981|Secondary|PANSS - Positive Subscale - Phases 1 and 2|The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Positive scale: 7 Items, (minimum score = 7, maximum score = 49)|Phase 1 timeframe is Baseline and Day 14; Phase 2 timeframe is Day 14 and Day 28|Ph 1 analysis includes the 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 22 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes the 18 Drug-Drug group subjects and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.|||units on a scale||Standard Deviation|Mean
2600237|NCT02164981|Primary|Change in Positive and Negative Syndrome Scale (PANSS) - Total Score - Study Phases 1 and 2|The Positive and Negative Syndrome Scale (PANSS) will be used to measure symptom severity in this trial. PANSS is a 30-item questionnaire used to evaluate schizophrenia symptoms, based on the clinical interview as well as reports of family members or primary care hospital workers. PANSS consists of Positive scale (7 items), Negative scale (7 items), and General Psychopathological scale (16 items) sections. Each item (symptom) will be scored on a 7-point scale with higher scores representing increasing levels of psychopathology: 1) Absent, 2) Minimal, 3) Mild, 4) Moderate, 5) Moderate severe, 6) Severe, and 7) Extreme. Total score minimum = 30, maximum = 210|For Phase 1, timeframe is Day 0 and Day 14; Phase 2 timeframe is Day 14 and Day 28|Ph 1 analysis includes 34 subjects with Baseline PANSS data in the Placebo-Placebo (N=18) and Placebo-Drug (N=16) groups and 18 Drug-Drug group subjects. Per SPCD, the Ph 2 data excludes 18 Drug-Drug group subjects and includes the 14 subjects in the Placebo-Drug group and 18 subjects in the Placebo-Placebo group with PANSS Baseline data.|||units on a scale||Standard Deviation|Mean
2600238|NCT02164929|Secondary|Length of Stay||Participants will be followed for the duration of hospital stay, an estimated 1 week||||Days||Standard Deviation|Mean
2600239|NCT02164929|Secondary|Number of Epidural-related Side Effects||Participants will be followed for the duration of hospital stay, an estimated 1 week||||Number of side effects|||Number
2600240|NCT02164929|Secondary|Time to First Ingestion of Solid Food||Participants will be followed for the duration of hospital stay, an estimated 1 week||||Days||Standard Deviation|Mean
2600241|NCT02164929|Secondary|Opioid Related Side Effects|Occurrence and duration of opioid related adverse events including postoperative nausea and vomiting (PONV); pruritus, urinary retention, confusion, sedation and respiratory depression at the above time points.|Participants will be followed for the duration of hospital stay, an estimated 1 week||||side effects|||Number
2600242|NCT02164929|Secondary|Time to First Bowel Movement||Participants will be followed for the duration of hospital stay, an estimated 1 week||||days||Standard Deviation|Mean
2600243|NCT02164929|Secondary|Complications as Measured by a Modified Postoperative Morbidity Survey (MPMS)|Complications using a Modified Postoperative Morbidity Survey (MPMS)|Participants will be followed for the duration of hospital stay, an estimated 1 week|Data not collected||||||
2600244|NCT02164929|Secondary|Quality of Recovery|Quality of Recovery Score (QoR-15) is measured on a scale of 0-150 (0=poor, 150 = excellent). Scores were collected daily for 72 hours and then averaged.|72 hours||||Units on a scale||Standard Deviation|Mean
2600245|NCT02164929|Secondary|Pain Scores|"Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where 0 represents no pain and 10 represents worst pain ever, at 30, 60, 90, 120 min and every 6 hours for 24 hours and every 12 hours for 48 hours and once a day thereafter until discharge. Data were collected at the indicated time points and an average pain score was calculated."|Participants will be followed for the duration of hospital stay, an estimated 1 week||||Units on a scale||Standard Deviation|Mean
2600246|NCT02164929|Primary|Postoperative Opioid Consumption|If opioid other than fentanyl is used, the dose will be converted to morphine equivalent.|24 hours after surgery||||mcg||Standard Deviation|Mean
2600247|NCT02164916|Other Pre-specified|Overall Response Rate in Patients Who Register to Arm 3 (Crossover) After Disease Progression on Arm 1|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years from randomization|Eligible and analyzable patients with measurable disease.|||Participants|||Count of Participants
2600248|NCT02164916|Other Pre-specified|Overall Survival in Patients Who Register to Arm 3 (Crossover) After Disease Progression on Arm 1|From date of randomization to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 3 years from randomization|Eligible and analyzable patients|||months||95% Confidence Interval|Median
2613882|NCT02015754|Secondary|Median Overall Survival|Median overall survival from start of therapy (DEBIRI #1) until death (or date of censor).|Up to 26 months||||months||Full Range|Median
2600249|NCT02164916|Other Pre-specified|Progression-free Survival in Patients Who Register to Arm 3 (Crossover) After Disease Progression on Arm 1|From date of Step 3 Crossover registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive without report of progression are censored at date of last contact. Progression is defined as one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesion/site; and/or death due to disease without prior documentation of progression and without symptomatic deterioration.|Up to 3 years from randomization|All eligible and analyzable patients.|||months||95% Confidence Interval|Median
2600250|NCT02164916|Other Pre-specified|Overall Response Rate|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years from randomization|All eligible and analyzable patients with measurable disease.|||Participants|||Count of Participants
2600251|NCT02164916|Other Pre-specified|Overall Survival|From date of randomization to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 3 years from randomization|Eligible and analyzable patients|||months||95% Confidence Interval|Median
2600252|NCT02164916|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.|||Participants|||Number
2600253|NCT02164916|Primary|Progression-free Survival|From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact. Progression is defined as one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesion/site; and/or death due to disease without prior documentation of progression and without symptomatic deterioration.|Up to 3 years from randomization|Eligible and analyzable patients.|||months||95% Confidence Interval|Median
2600254|NCT02164864|Secondary|Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG|Time to event analysis of patients with death or thrombotic event (all death, myocardial infarction, stroke/systemic embolism) or unplanned revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft. The number of observed patients with death or first thrombotic event or unplanned revascularisation by PCI/CABG was reported.|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
2600255|NCT02164864|Secondary|Time to First Adjudicated Unplanned Revascularisation by PCI/CABG|Time to event analysis of patients with adjudicated unplanned revascularisation by Percutaneous Coronary Intervention (PCI)/Coronary Artery Bypass Graft (CABG). The number of observed patients with adjudicated unplanned revascularisation by PCI/CABG was reported.|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
2600256|NCT02164864|Secondary|Time to Composite Endpoint of Death or First Thrombotic Event|Time to event analysis of patients with composite endpoint of death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)). The number of observed patients with composite endpoint of death or thrombotic event (all death, MI, stroke/SE).|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
2600257|NCT02164864|Secondary|Time to Composite Endpoint of Death + MI + Stroke|Time to event analysis of patients with the composite endpoint of death + myocardial infarction (MI) + stroke. The number of observed patients with the composite endpoint of death + myocardial infarction (MI) + stroke was reported.|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
2600258|NCT02164864|Secondary|Time to First Adjudicated ST|Time to event analysis of patients with first adjudicated Stent Thrombosis (ST). The number of observed patients with adjudicated ST was reported.|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
2600259|NCT02164864|Secondary|Time to First Adjudicated SE|"Time to event analysis of patients with first adjudicated Systemic embolism (SE). The number of observed patients with adjudicated SE was reported.~SE is an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and had to be documented by angiography, surgery, scintigraphy, or autopsy."|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
2600260|NCT02164864|Secondary|Time to First Adjudicated Stroke|"Time to event analysis of patients with first adjudicated Stroke. The number of observed patients with adjudicated Stroke was reported.~Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction"|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
2600261|NCT02164864|Secondary|Time to First Adjudicated MI|Time to event analysis of patients with first adjudicated Myocardial Infarction (MI). The number of observed patients with adjudicated MI was reported|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
2600262|NCT02164864|Secondary|Time to Adjudicated All Cause Death|Time to event analysis of patients with adjudicated all cause death. The number of observed patients with adjudicated all cause death was reported. All cause death is defined as the death from any cause included CV death, non-CV death, and undetermined cause of death.|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
2600263|NCT02164864|Secondary|Time to Adjudicated CV|"Time to event analysis of patients with adjudicated Cardiovascular (CV) death. The number of observed patients with adjudicated Cardiovascular (CV) death was reported.~CV death included death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to CV procedures, death due to CV haemorrhage, and death due to other CV causes."|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
2600264|NCT02164864|Secondary|Time to Adjudicated Non-CV|"Time to event analysis of patients with adjudicated Non-cardiovascular (Non-CV). The number of observed patients with adjudicated Non-CV was reported.~Non-CV death was defined as any death with a specific cause that was not thought to be CV. These were possible examples of non-CV causes of death: Pulmonary, Renal, Gastrointestinal, Hepatobiliary, Pancreatic Infection(included sepsis), Inflammatory (e.g. systemic inflammatory response syndrome) or immune (including autoimmune), Haemorrhage that was neither CV bleeding nor a stroke, Non-CV procedure or surgery, Trauma, Suicide, Non-prescription drug reaction or overdose, Prescription drug reaction or overdose, Neurological (non-CV), Malignancy, Other non-CV"|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
2600265|NCT02164864|Secondary|Time to Adjudicated Undetermined Cause of Death|"Time to event analysis of patients with adjudicated Undetermined cause of death. The number of observed patients with adjudicated Undetermined cause of death was reported.~This is referred to a death not attributable to cardiovascular (CV) death or to a non-cardiovascular (non-CV) cause. Inability to classify the cause of death may have been due to lack of information (e.g. the only available information was patient died) or when there was insufficient supporting information or detail to assign the cause of death."|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
2600266|NCT02164864|Primary|Time to First Adjudicated ISTH MBE or CRNMBE|"Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported.~Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation period for this analysis set was the date of randomisation. Patients who discontinued trial medication were followed until the end of the trial.~Patients who were lost to follow-up for vital status were censored for the primary endpoint at the time of their last known vital status.~Intention to treat period: The observation period for these analysis was the so called 'intention to treat period'."|up to 30 months|Full Analysis set (FAS) following the intention-to-treat principle.|||Participants|||Count of Participants
2600267|NCT02164721|Other Pre-specified|Effects of CRT on Frequency of Heart Failure|Effects of CRT on the frequency of heart failure with end point of inpatient hospitalization with augmented treatment for heart failure|6 months post implant|Frequency of heart failure described in the study population.|||participants|||Number
2600268|NCT02164721|Other Pre-specified|Change in Left Atrial Size|Change in left atrial size between baseline and six months|6 months post implant|Change in left atrial size between baseline and six months was analyzed in 26 patients with data available.|||ml||Standard Deviation|Mean
2600269|NCT02164721|Other Pre-specified|Change in New York Heart Association (NYHA) Functional Class|Improvement in NYHA functional class between baseline and six months (yes/no), ie. change from NYHA class III to NYHA II.|6 months post implant|Improvement in NYHA functional class between baseline and six months (yes/no) in 29 participants with data available.|||participants|||Number
2600270|NCT02164721|Secondary|Effects of CRT Therapy on Left Ventricular Volume at End Systole|Determine based on echocardiogram study if CRT therapy improves left ventricular volume at end systole (LVESV) between baseline and six months|6 months post implant|Describe changes in LVESV in 23 patients with data available|||ml||Standard Deviation|Mean
2600271|NCT02164721|Secondary|Effects of CRT Therapy on Left Ventricular Volume at End Diastole|Determine based on echocardiogram study if CRT therapy improves left ventricular volume at end diastole (LVEDV) between baseline and six months|6 months post implant|Describe 23 patients with data available on LVEDV change|||ml||Standard Deviation|Mean
2600272|NCT02164721|Secondary|Number of Participants With All-Cause Mortality|Number of Participants with All-Cause Mortality in CRT-D patients|6 months post implant|Event rate of all-cause mortality is described.|||participants|||Number
2600273|NCT02164721|Primary|Change in Left Ventricular Ejection Fraction|The primary endpoint will be the change in left ventricular ejection fraction (LVEF) from baseline to six months|6 months post implant|Change in left ventricular ejection fraction (LVEF) from baseline to six months was analyzed with 26 patients with data available.|||percentage of LVEF||Standard Deviation|Mean
2600274|NCT02164539|Secondary|Change in Clinic FEV1 Following 2 Puffs of Albuterol/Salbutamol Given 3 Hours Post-study Treatment Dose at Visit 5/Day 28|FEV1 is defined as forced expiratory volume in one second and measured in the morning at Visits 1 through 8 between 6:00 and 11:00 electronically by spirometry. Reversibility was measured at Visit 1 and Visit 2 for study eligibility by change in clinic FEV1 within 20 to 60 minutes following 4 inhalations of albuterol/salbutamol and again measured 3 hours after dosing at Visit 5 by change in clinic FEV1 30 minutes following 2 inhalations of albuterol/salbutamol. Baseline value of clinic FEV1 is the last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomization (either from Visit 3 pre-dose or from Visit 2 pre-bronchodilator). Analysis performed using analysis of covariance with covariates of treatment, age, sex, baseline clinic trough FEV1, pre-albuterol/salbutamol FEV1 at Visit 5, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification.|Baseline and Day 28|ITT Population. Only those participants available at the specified time point were analyzed.|||Liters (L)||Standard Error|Least Squares Mean
2600289|NCT02164318|Secondary|Count of Participants Using Their AVF for Dialysis|Successful use of AVF at 12 months in dialysis dependent patients. Not relevant in participants that are predialysis or that discontinue dialysis prior to AVF use.|12 months post surgery|Only subjects who were on dialysis at 12 months are included in the analysis. Only 5 participants were on dialysis at this time.|||Participants|||Count of Participants
2601641|NCT02150954|Secondary|Incidence of Uterine Hyperstimulation|Uterine hyperstimulation (tachysystole) was defined as uterine contractions occurring greater than 12 in 20 minutes.|during admission for delivery, up to approximately 4 days||||participants|||Number
2600275|NCT02164539|Secondary|Change From Trough in Clinic Forced Expiratory Volume (FEV1) at 3 Hours Post-study Treatment at Visit 5/Day 28|FEV1 was measured in the morning by spirometry. At Visit 5, after trough FEV1 is measured, subject received investigational product. 3 hours post-dose, spirometry was repeated and subject then received 2 puffs of albuterol/salbutamol. After 30 minutes,spirometry was repeated.. Change from Baseline in clinic trough (pre-dose) FEV1 is the difference in the trough value at 3 hours post-dose peak FEV1 and the Baseline value. If the trough value or the Baseline was missing, then change from Baseline was considered as missing. Baseline value of clinic FEV1 is the last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomization (from Visit 3 pre-dose or from Visit 2 pre-bronchodilator). Analysis done using analysis of covariance with covariates of treatment, age, sex, baseline clinic trough FEV1, pre-dose trough FEV1 at Visit 5, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification.|Baseline and Day 28|ITT Population. Only those participants available at the specified time point were analyzed.|||Liters (L)||Standard Error|Least Squares Mean
2600276|NCT02164539|Secondary|Change From Baseline in Daily Morning (AM) PEF (Pre-dose and Pre-rescue Bronchodilator) Measured at Home and Averaged Over the Last 21 Days of Treatment Phase A|Peak expiratory flow (PEF) stability limit was calculated from AM PEF measurements on the 7 days preceding Visit 3 as mean AM PEF from the available 7 days preceding Visit 3 x 80%. PEF stability limit serves as a benchmark of the participants run-in COPD status and used for comparison during the treatment phase to assess subject safety. Change from Baseline over the last 21 days of Treatment Phase A is the difference between the last 21 days of Treatment Phase A and the appropriate Baseline week. The last 21 days of Treatment Phase A include the AM assessments on the date of Visit 6. AM assessments include the date of Visit 6 and the 20 consecutive days preceding the date of Visit. Analysis performed using analysis of covariance with covariates of treatment, age, sex, Baseline AM PEF, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. Baseline is the last 7 days of the run-in period prior to randomization|Baseline and from Day 8 through Day 29|ITT Population. Only those participants available at the specified time point were analyzed.|||Liters per minute (L/min)||Standard Error|Least Squares Mean
2600277|NCT02164539|Secondary|Mean Change From Baseline in E-RS Total Scores at the End of Treatment Phase A|A daily symptoms score for exacerbations of chronic pulmonary disease tool - Respiratory Symptoms (E-RS) is derived by summing the 11 item-level E-RS scores and has a theoretical range of 0-40, with higher values indicating more severe respiratory symptoms. The Baseline E-RS score is defined as the mean within-subject daily score over the 7 days prior to randomization, with data present for a minimum of 4 of the 7 days. Change from Baseline at the end of Treatment Phase is the difference between the end of Treatment Phase value and the appropriate Baseline week. Analysis performed using analysis of covariance with covariates of treatment, age, sex, baseline score, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. Baseline is the last 7 days of the run-in period prior to randomization. All comparisons for statistical purposes are with the FF 100 µg arm.|Baseline and End of Treatment Phase A (The end of Treatment Phase A was defined as the last 7 days of Treatment Phase A, including the AM assessments on the date of Visit 6)|ITT Population. Only those participants available at the specified time point were analyzed.|||Score on scale||Standard Error|Least Squares Mean
2600278|NCT02164539|Secondary|Mean Change From Baseline in Rescue Medication Use at the End of Treatment Phase A|All participants received the albuterol/salbutamol via MDI as a rescue medication on an as-needed basis. Total daily rescue medication use for a given day is the sum of daytime albuterol/salbutamol use recorded in PM and nighttime albuterol/salbutamol use recorded in AM the next day. The number of puffs of albuterol (salbutamol) MDI used in the last 12 hours for relief of symptoms were recorded morning and evening in the eDiary by the participants. End of Treatment Phase A is the last 7 days of Treatment Phase A. Change from Baseline at the end of Treatment Phase is the difference between the end of Treatment Phase value and the appropriate baseline week. Analysis performed using analysis of covariance with covariates of treatment, age, sex, baseline rescue medication use, pack years smoked per randomization stratification and age when first treated with an inhaler per randomization stratification. Baseline is the last 7 days of the run-in period prior to randomization|Baseline and End of Treatment Phase A (The end of Treatment Phase A was defined as the last 7 days of Treatment Phase A, including the AM assessments on the date of Visit 6)|ITT Population. Only those participants available at the specified time point were analyzed.|||Puffs||Standard Error|Least Squares Mean
2600279|NCT02164539|Primary|Change From Baseline in Clinic Trough Forced Expiratory Volume in One Second (FEV1) at the End of Treatment Phase A (Visit 6/Day 29)|FEV1 is defined as forced expiratory volume in one second and measured in the morning at Visits 1 through 8 between 6:00 and 11:00 electronically by spirometry. Change from Baseline in trough FEV1 is defined as the difference in the value obtained at Visit 6 (24 hours post-dose on Visit 5) and the last acceptable/borderline acceptable value obtained prior to randomization (from Visit 2 pre-bronchodilator or Visit 3 pre-dose). Trough FEV1 is defined as the acceptable/borderline acceptable FEV1 value obtained at Visit 6, approximately 24 hours after morning dosing on Visit 5. ITT population is comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. All comparisons for statistical purposes are with the FF 100 µg arm.|Baseline and Day 29|ITT Population. Only those participants available at the specified time point were analyzed.|||Liters||Standard Deviation|Mean
2600280|NCT02164513|Secondary|Annual Rate of On-treatment Severe Exacerbations Comparing FF/UMEC/VI With FF/VI and With UMEC/VI|The annual rate of severe COPD exacerbations during the treatment, has been reported. Severe exacerbations were defined as exacerbations that required hospitalization or resulted in death. The covariates of treatment group, sex, exacerbation history (<=1, >=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted FEV1 (Screening) were used. Only those participants with non-missing co-variates were included in the analysis|Up to Week 52|ITT Population.|||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
2600290|NCT02164318|Secondary|Count of Participants With a Patent Fistula|Determination that AVF is patent (has blood flow, no occlusion).|3 months post surgery|Two subjects withdrew from this study prior to their AVF surgery, therefore they were not included in the analysis population.|||Participants|||Count of Participants
2617046|NCT01984424|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
2600281|NCT02164513|Secondary|Time to First On-treatment Moderate/Severe Exacerbation Comparing FF/UMEC/VI With UMEC/VI in the Subset of Particpants With a Blood Eosinophil Count >=150 Cells Per Microliter at Baseline|This measures the number of days, to the first onset of moderate or severe exacerbations for participants with blood eosinophil count >=150 cells per microliter, at Baseline has been reported. Moderate exacerbations, were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death). Severe exacerbations, were defined as exacerbations that required hospitalization or resulted in death. Only those participants with non-missing co-variates and non missing eosinophils at Baseline were included in the analysis. First quartile and median time to onset are taken from the Kaplan-Meier estimates. If <25% (and <50%) of participants experienced the event within a treatment then Q1 (and median) time to onset are displayed as NA (not applicable) for that treatment.|Up to Week 52|ITT Population|||Days|||Number
2600282|NCT02164513|Secondary|Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI in the Subset of Participants With a Blood Eosinophil Count >=150 Cells Per Microliter|The annual rate of moderate or severe COPD exacerbations during the treatment, for participants with blood eosinophil count >=150 cells per microliter , has been reported. Moderate exacerbations, were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death). Severe exacerbations were defined as exacerbations that required hospitalization or resulted in death. Only those participants with non-missing co-variates and non-missing eosinophil, at Baseline were included in the analysis.|Up to Week 52|ITT Population|||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
2600283|NCT02164513|Secondary|Time to First On-treatment Moderate/Severe Exacerbation Comparing FF/UMEC/VI With FF/VI and With UMEC/VI|This measures the number of days, to the first onset of moderate or severe exacerbations. Moderate exacerbations, were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death). Severe exacerbations, were defined as exacerbations that required hospitalization or resulted in death. The Hazard ratio from Cox proportional hazards model with covariates of treatment group, sex, exacerbation history (<=1, >=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted FEV1 (Screening), have been reported. Only those participants with non-missing co-variates were included in the analysis. First quartile and median time to onset are taken from the Kaplan-Meier estimates. If <25% (and <50%) of participants experienced the event within a treatment then Q1 (and median) time to onset are displayed as NA (not applicable) for that treatment.|Up to Week 52|ITT Population.|||Days|||Number
2600284|NCT02164513|Secondary|Change From Baseline in St. George's Respiratory Questionnaire for (SGRQ) Total Score at Week 52 Comparing FF/UMEC/VI With FF/VI|SGRQ is a disease specific-questionnaire, designed to measure impact of respiratory disease and its treatment on a COPD participant's Health Related Quality of Life (HRQoL). SGRQ contains 14 questions with total of 40 items grouped into three domains (Symptoms, Activity, and Impacts). The overall summary score along with scores for the individual domains of symptoms, activity and impacts were assessed. Score was calculated by summing the pre-assigned weights of answers, dividing by sum of maximum weights for items in SGRQ. Total scores ranged from 0 to 100. A decrease in score indicates improvement in HRQoL and higher score implies worse quality of life. Change from Baseline was calculated as total score at Week 52 minus value at Baseline. Baseline was defined as Day 1. Minimum clinically important difference (MCID) for this instrument is a 4-point improvement (decrease from Baseline). Only those participants with non-missing co-variates were included in the analysis.|Baseline and Week 52|ITT Population.|||Scores on SGRQ scale||Standard Error|Least Squares Mean
2600285|NCT02164513|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1), at Week 52 Comparing FF/UMEC/VI With FF/VI|FEV1 was defined as the amount of air a person exhales in one second. Change from Baseline was calculated as the value of FEV1 at Week 52 minus the value at Baseline. Baseline for trough FEV1 was defined as Day 1 (Pre-dose). Only those participants with non-missing co-variates were included in the analysis. The analysis was performed using a Repeated measures model with covariates of treatment group, smoking status (Screening), geographical region, visit, Baseline, Baseline by visit and treatment group by visit interactions.|Baseline and Week 52|ITT Population.|||Liter||Standard Error|Least Squares Mean
2600286|NCT02164513|Primary|Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI and FF/VI|The annual rate of moderate or severe COPD exacerbations which occurred during treatment was assessed. Moderate exacerbations were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death). Severe exacerbations were defined as exacerbations that required hospitalization or resulted in death. Analysis performed using a generalized linear model assuming a negative binomial distribution. ITT population was used which comprised of all randomized participants, excluding those who were randomized in error. Only those participants with non-missing co-variates were included in the analysis.|Up to Week 52|ITT Population.|||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
2600287|NCT02164396|Primary|Lid-Parallel Conjunctival Folds (LIPCOF)|LIPCOF was assessed at baseline to 2-, 4-, 8- and 12- week Follow-up. Each subject eye was graded using a 4- point using the scale (Grade 0: No conjunctival folds, Grade 1: One permanent and clear parallel fold, Grade 2: Two permanent and clear parallel folds, (normally lower than 0.2mm) and Grade 3: More than two permanent and clear parallel folds, (normally higher than 0.2mm) at two 2 locations in the eye (Temporal and Nasal). The graded responses for each location (Temporal and Nasal) was average. The sum of the average LIPCOF grade for Temporal and Nasal was reported. (Score=average Nasal Grade + average Temporal Grade).|Baseline, 2-, 4-, 8- and 12-Week Follow-up|The analysis population consists of all subjects that completed the study without a major protocol deviation.|||Score|observations|Standard Deviation|Mean
2600288|NCT02164383|Primary|Change Between Baseline Mean Cigarettes Smoked Per Day and Mean Cigarettes Smoked Per Day During the First 4 Weeks of the Quit Attempt Calculated as Percentage Change|Every day participants will report the number of cigarettes they smoked that day at baseline and for the first 4 weeks of the quit attempt (starting on the target quit day) using timeline followback assessment. This information will be used to calculate a participant's change in mean cigarettes smoked per day from baseline compared to the mean across the first 4 weeks of the quit attempt calculated as percentage change.|Cigarettes per day measured daily for the first 4 weeks of the quit attempt (starting on the target quit day) and at baseline||||percentage change in cigarettes per day||Standard Deviation|Mean
2600291|NCT02164318|Primary|Count of Participants With Mature Arteriovenous Fistula (AVF)|Use of AVF for dialysis for dialysis dependent participants, or fistula deemed mature based on physical exam in predialysis participants (diameter >6 mm, blood flow >600 ml by ultrasound or estimated by physical exam).|3 month post surgery to create AVF|Two subjects withdrew from this study prior to their AVF surgery, therefore they were not included in the analysis population.|||Participants|||Count of Participants
2600292|NCT02164240|Secondary|Median Progression Free Survival (mPFS)|Non-parametric Kaplan-Meier analysis to assess median progression free survival (mPFS)|From date of registration until date of protocol-defined progression while on this protocol, assessed up to 6 months|all patients enrolled were analyzed as a single cohort for this endpoint based on pre-planned study design|||months||95% Confidence Interval|Median
2600293|NCT02164240|Secondary|Percentage of Participants With Clinical Benefit|Percentage of participants who experienced complete response, partial response or stable disease per RECIST 1.1 at 16 weeks|16 weeks|clinical benefit was analyzed across the entire population based on the pre-planned study design|||Participants|||Count of Participants
2600294|NCT02164240|Primary|Number of Participants With Serious and Non-Serious Adverse Events|Dose-escalation cohort is to determine the frequency and characteristics of DLTs of alternation of sunitinib and regorafenib at each dose level during the first cycle of therapy. Toxicity will be graded accordingly with NCI CTCAE version 4.0|Up to Day 28||||Participants|||Count of Participants
2600295|NCT02163993|Secondary|Mean Change From Baseline in the Number of Moderate-Severe Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase|"Number of calendar days on which headache lasts ≥4 hrs it includes migraines, PM & non-migraines. MH is headache with or without aura, of ≥30 min duration, and with both (A and B) required features from IHS ICHD-3 beta definition. Required feature A includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature B includes at least 1 of following during headache: nausea &/or vomiting, or photophobia & phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. Severity was measured via interactive voice response system questionnaire What was the worst headache pain? For mild press 1. For moderate 2. For severe press 3. LSmean was calculated using MMRM with treatment, pooled investigative site, period, treatment-by-period interaction, baseline and baseline-by-period interaction."|Baseline, 12 Weeks|All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.|||Days||Standard Error|Least Squares Mean
2600296|NCT02163993|Secondary|Mean Change From Baseline in the Number of Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase|"Number of calendar days on which a headache lasts ≥4 hours which includes migraines, probable migraines (PM) and nonmigraines. Criteria for migraine headache (MH) was adapted from standard IHS ICHD-3 beta definition. It is defined as headache with or without aura, of ≥30 min duration, and with both (A and B) required features from IHS ICHD-3 beta definition. Required feature A includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature B includes at least 1 of following during headache: nausea and/or vomiting, or photophobia and phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. LS means were calculated using MMRM with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction."|Baseline, 12 Weeks|All randomized participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.|||Days||Standard Error|Least Squares Mean
2600297|NCT02163993|Secondary|Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores|"The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal behavior: a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide."|Baseline through Week 12|All randomized participants who received at least 1 dose of study drug and with non-missing baseline and postbaseline C-SSRS assessment.|||Percentage of Participants|||Number
2600298|NCT02163993|Secondary|Percentage of Participants Developing Anti-drug Antibodies to Galcanezumab|The percent of participants with treatment emergent Anti-drug Antibodies (ADA) were assessed at week 1 to 12. A participant was considered to have treatment-emergent Galcanezumab ADA if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as any of the following: A negative baseline ADA result and a subsequent positive post-baseline ADA result with a titer >=20; or a positive ADA results and a subsequent positive post-baseline ADA results with a 4-fold or greater increase in titer from the baseline measurement.|Baseline through 12 Weeks|All randomized participants who received at least 1 dose of study drug with non-missing baseline and postbaseline ADA measures.|||Percentage of participants|||Number
2600299|NCT02163993|Secondary|Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)|CGRP has been shown to be involved in the pathophysiology of migraine through dilation of cerebral and dural blood vessels, release of inflammatory mediators, and transmission of nociceptive (pain) information from intracranial blood vessels to the nervous system (Villalón and Olesen 2009). In migraineurs, serum concentrations of CGRP are significantly elevated during migraine attacks (Goadsby et al. 1990; Goadsby and Edvinsson 1993).|12 Weeks|All randomized participants who received at least 1 dose of study drug with non-missing baseline and postbaseline measures for CGRP plasma concentration.|||nanomoles per litre (nmol/L)||Standard Deviation|Mean
2600300|NCT02163993|Secondary|Serum Concentration of Galcanezumab|Blood serum concentrations of galcanezumab.|12 Weeks|All randomized participants who received at least 1 dose of study drug with non-missing baseline and postbaseline measures for serum concentration of galcanezumab.|||nanomoles per litre (nmol/L)||Standard Deviation|Mean
2600721|NCT02159079|Secondary|Ventilator-free Days to Day 14|A secondary outcome will be the number of ventilator-free days (defined as the number of days alive and breathing unassisted after the final achievement of unassisted breathing before day 14)|14 days||||days||Inter-Quartile Range|Median
2600301|NCT02163993|Secondary|Change From Baseline to 12 Week Endpoint in the Headache Impact Test-6™ (HIT-6™) Scores|The HIT-6 consists of 6 questions to measure the impact of headaches on the participants ability to function on the job, at school, at home and in social situations. A score to each question will be assigned as follows: never - 6, rarely - 8, sometimes - 10, very often - 11, and always - 13. The composite score is calculated as the sum of the scores for all 6 questions, the total score ranges between 36 and 78 with higher total scores reflecting more severe impact of headaches. LS means was determined by ANCOVA with treatment, pooled investigative site and baseline.|Baseline, 12 Weeks|All randomized participants who received at least 1 dose of study drug and have non-missing values at baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2600302|NCT02163993|Secondary|Change From Baseline to 12 Week Endpoint in Migraine Specific Quality of Life (MSQL) Questionnaire Total Scores|MSQL consists of 14 questions across 3 dimensions (role function-restrictive, role function-preventive, and emotional function). All question values range from 1 to 6. Participants rated each item from 1 (none of the time) to 6 (all of the time). Since each item was presented as a negative statement, participant responses were recorded before item scores were calculated. Then, dimension scores were calculated as the sum of the recorded items for that specific dimension. Each dimension score was transformed into a score that ranged from 0 to 100. The transformation formula for the restrictive function = [(dimension score-7)*100]/35, for the preventive function = [(dimension score-4)*100]/20, and for the emotional function = [(dimension score-3)*100]/15. A lower score indicated a poorer quality of life associated with that domain. LS means was determined by Analysis of covariance (ANCOVA) with treatment, pooled investigative site and baseline.|Baseline, 12 Weeks|All randomized participants who received at least 1 dose of study drug and have non-missing values at baseline and post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2600303|NCT02163993|Secondary|Mean Change From Baseline in Number of Headache Hours in the Last 28-Day Period of the 12-Week Treatment Phase|Number of headache hours calculated as the total number of headache hours in a 28-day period on which a headache occurred. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction.|Baseline, 12 Weeks|All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.|||Hours||Standard Error|Least Squares Mean
2600304|NCT02163993|Secondary|Mean Change From Baseline in the Number of Days of Medication Use for the Treatment of Migraine Headache in the Last 28-Day Period of the 12-Week Treatment Phase|"A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria was adapted from the standard IHS ICHD-3 beta definition. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both (A and B) required features from the IHS ICHD-3 beta definition. Required feature A includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature B includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least Squares (LS) means was determined by mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction."|Baseline, 12 Weeks|All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.|||Days||Standard Error|Least Squares Mean
2600305|NCT02163993|Secondary|Percentage of Participants With ≥50% Reduction in Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase|"The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta definition. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both (A and B) required features from the IHS ICHD-3 beta definition. Required feature A includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature B includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia."|Week 12|All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data during the time period of analysis.|||Percentage of participants|||Number
2600306|NCT02163993|Secondary|Mean Change From Baseline in Number of Migraine Attacks in the Last 28-Day Period of the 12-Week Treatment Phase|"A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria was adapted from the standard IHS ICHD-3 beta definition. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both (A and B) required features from the IHS ICHD-3 beta definition. Required feature A includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature B includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least Squares (LS) mean was calculated using mixed model repeated measures (MMRM) methodology with treatment, pooled investigative site, period, and treatment-by-period interaction, baseline and baseline-by-period interaction."|Baseline, 12 Weeks|All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.|||Migraine attacks||Standard Error|Least Squares Mean
2600321|NCT02163915|Primary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 up to Day 14|Safety analysis set was defined as all participants who received at least one dose of study drug.|||percentage of participants|||Number
2600307|NCT02163993|Primary|Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase|"The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta. The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both (A and B) required features from the IHS ICHD-3 beta definition. Required feature A includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature B includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia."|Baseline, 12 Weeks|All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.|||Days||Standard Deviation|Mean
2600308|NCT02163967|Secondary|Change in Low Frequency Heart Rate Variability|Low frequency heart rate variability will be calculated over successive 5 minute intervals from continuous ECG recordings and reported on a log scale with a minimum of 0 and a maximum of 10. Higher scores represent more heart rate variability.|Low frequency heart rate variability is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation|3 enrolled subjects who did not complete all 3 stimulation sessions were not included in the analysis.|||Units on a Log Scale||Standard Error|Mean
2600309|NCT02163967|Secondary|Change in Heart Rate|Heart rate will be calculated over successive 5 minute intervals from continuous ECG recordings. Higher scores represent faster heart rate|Mean heart rate is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation|3 subjects who did not complete all 3 stimulation sessions were not included in the analysis|||beats per minute||Standard Error|Mean
2600310|NCT02163967|Secondary|Number of Subjects Reporting Light Flickering in Peripheral Vision Side Effect|Subjects were asked to report any side effects of the stimulation. Of all side effects reported by subjects, only light flickering in peripheral vision was endorsed by enough subjects to allow statistical analysis|one hour|All 21 subjects who completed at least one of the stimulation study visits are included in this analysis|||participants|||Number
2600311|NCT02163967|Primary|Change in High Frequency Heart Rate Variability|High frequency heart rate variability (HRV) will be calculated over successive 5 minute intervals from continuous ECG recordings and reported on a log scale with a minimum of 0 and a maximum of 10. Higher scores represent more heart rate variability.|Mean HRV is calculated for the 15 minutes of baseline, for the 20 minutes of stimulation and for the 15 minutes post stimulation|3 subjects who did not complete testing sessions at all 3 stimulation doses we not included in the final analysis|||Units on a Log Scale||Standard Error|Mean
2600312|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.|||percentage of participants|||Number
2600313|NCT02163915|Secondary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-137|Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.|Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose|Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.|||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
2600314|NCT02163915|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-137|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Days 1 and 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose|Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.|||hours||Full Range|Median
2600315|NCT02163915|Secondary|Cmax, ss: Maximum Observed Plasma Concentration at Steady State for TAK-137|Maximum observed steady-state plasma concentration during a dosing interval.|Day 7 pre-dose and at multiple timepoints (up to 24 hours) post-dose|Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.|||ng/mL||Standard Deviation|Mean
2600316|NCT02163915|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-137|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose|Pharmacokinetic analysis set was defined as all participants who received at least one dose of study drug and had at least one measurable plasma concentration.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2600317|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Heart Rate Measurements at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.|||percentage of participants|||Number
2600318|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Blood Pressure Measurements at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.|||percentage of participants|||Number
2600319|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Pulse Measurements at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.|||percentage of participants|||Number
2600320|NCT02163915|Primary|Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose||Day 1 up to Day 8|Safety analysis set was defined as all participants who received at least one dose of study drug.|||percentage of participants|||Number
2600334|NCT02163733|Secondary|Tmax of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of time to Cmax.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).|||h||Full Range|Median
2600322|NCT02163902|Secondary|Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits|"The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).~The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).~Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis."|From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment|Analysis Population: Participants who were both CR-2 responders and PR-2 responders (SMFRS-2) at 12-weeks after last treatment in the predecessor studies.|||percentage of participants||95% Confidence Interval|Number
2600323|NCT02163902|Secondary|Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits|"The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).~The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).~Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis."|From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment|Analysis Population: Participants who were both CR-1 responders and PR-1 responders (SMFRS-1) at 12-weeks after last treatment in the predecessor studies.|||percentage of participants||95% Confidence Interval|Number
2600324|NCT02163902|Secondary|Percentage of Participants Maintaining PR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits|"The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).~Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis."|From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment|Analysis Population: Participants who had at least a 2-grade reduction from baseline in PR-SMFRS (ie, PR-2 responder) at 12-weeks after last treatment in the predecessor studies.|||percentage of participants||95% Confidence Interval|Number
2600325|NCT02163902|Secondary|Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits|"The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).~Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis."|From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment|Analysis Population: Participants who had at least a 1-grade reduction from baseline in PR-SMFRS (ie, PR-1 responder) at 12-weeks after last treatment in the predecessor studies.|||percentage of participants||95% Confidence Interval|Number
2600326|NCT02163902|Secondary|Percentage of Participants Maintaining CR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits|"The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).~Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis"|From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment.|Analysis Population: Participants who had at least a 2-grade reduction from baseline on the CR-SMFRS (ie, CR-2 responder) at 12-weeks after last treatment in the predecessor studies.|||percentage of participants||95% Confidence Interval|Number
2600327|NCT02163902|Primary|Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits|"The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).~Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis."|From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment|Participants who had at least a 1-grade reduction from baseline on the CRSMFRS (ie, CR-1 responder) at 12-weeks after last treatment in the predecessor studies.|||percentage of participants||95% Confidence Interval|Number
2600328|NCT02163837|Other Pre-specified|Number of Steps Walked Daily|number of steps walked daily assessed by actigraphy (measure of physical activity)|28 days||||steps per day||Full Range|Median
2600329|NCT02163837|Other Pre-specified|Total Sleep Time|total sleep time/ 24h, measured in minutes, by actigraphy|28 days||||minutes||Full Range|Median
2600330|NCT02163837|Other Pre-specified|Quality of Sleep|assessed by Pittsburgh sleep quality index questionnaire (PSQI). Values: 0 to 21. 21= worse sleep quality|28 days||||units on a scale||Standard Deviation|Mean
2600331|NCT02163837|Secondary|Sleep Efficiency|total sleep time/ time spent in bed per 24h, expressed in percentage of time spent in bed, assessed by actigraphy|28 days||||percentage||Standard Deviation|Mean
2600332|NCT02163837|Primary|Percentage of Slow Wave Sleep and REM Sleep|sum of percentage of sleep spent in slow wave sleep and REM sleep during sleep per 24h ; assessed by 24-h polysomnography|28 days||||percentage of total sleep time per 24h||Standard Deviation|Mean
2600333|NCT02163733|Secondary|t1/2 of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of the terminal half-life.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).|||h||Full Range|Geometric Mean
2600335|NCT02163733|Secondary|AUC(0-120) of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of area under the plasma concentration time curve from zero to 120 hours.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).|||nM*h||Full Range|Geometric Mean
2600336|NCT02163733|Secondary|AUC(0-t) of AZ5104 and AZ7550|Area under the plasma concentration curve from time zero to last quantifiable dose for AZ5104 and AZ7550 (metabolites to AZD9291).|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).|||nM*h||Full Range|Geometric Mean
2600337|NCT02163733|Secondary|Cmax of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of maximum plasma concentration.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).|||nM||Full Range|Geometric Mean
2600338|NCT02163733|Secondary|AUC(0-72) of AZ5104 and AZ7550|Pharmacokinetics of AZ5104 and AZ7550 (metabolites to AZD9291) by assessment of area under the plasma concentration time curve from zero to 72 hours.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax for respective metabolite).|||nM*h||Full Range|Geometric Mean
2600339|NCT02163733|Secondary|Vz/F of AZD9291|Rate and extent of absorption of AZD9291 by assessment of the apprarent volume of distribution.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).|||L||Full Range|Geometric Mean
2600340|NCT02163733|Secondary|CL/F of AZD9291|Rate and extent of absorption of AZD9291 by assessment of apparent clearance following oral administration.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).|||L/h||Full Range|Geometric Mean
2600341|NCT02163733|Secondary|t1/2 of AZD9291|Pharmacokinetics of AZD9291 by assessment of the terminal half-life.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).|||h||Full Range|Geometric Mean
2600342|NCT02163733|Secondary|Tmax of AZD9291|Pharmacokinetics of AZD9291 by assessment of time to Cmax.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).|||h||Full Range|Median
2600343|NCT02163733|Secondary|AUC(0-120) of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 120 hours.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 120 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).|||nM*h||Full Range|Geometric Mean
2600344|NCT02163733|Secondary|AUC(0-t) of AZD9291|Area under the plasma concentration curve from time zero to last quantifiable dose.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).|||nM*h||Full Range|Geometric Mean
2600345|NCT02163733|Secondary|AUC of AZD9291|Area under the plasma concentration curve from zero extrapolated to infinity.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).|||nM*h||Full Range|Geometric Mean
2600386|NCT02163499|Secondary|Proportion of Subjects With Mean S-K Between 3.5 and 5.5 mmol/L, Inclusive Months 3 to 12|Proportion of Subjects with mean S-K between 3.5 and 5.5 mmol/L during Extended Dosing Phase - ITT Population|Study Days 85 to 365|Extended phase ITT population|||Proportion of participants||95% Confidence Interval|Number
2600346|NCT02163733|Primary|Cmax of AZD9291|Pharmacokinetics of AZD9291 by assessment of maximum plasma AZD9291 concentration.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients had at least 1 dose AZD9291 and had sufficient postdose PK to determine parameter without important protocol deviations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax). Note 1 patient missing key 8 hour sample so not included in Cmax analysis.|||nM||Full Range|Geometric Mean
2600347|NCT02163733|Primary|AUC(0-72) of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 72 hours.|Blood samples collected on Day 1 and Day 10 at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine parameter without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >5% of Cmax).|||nM*h||Full Range|Geometric Mean
2600348|NCT02163577|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)|An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE is defined as an AE or suspected adverse reaction that at any dose results in any of the following outcomes: death; life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect. Severity was graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). TEAEs are defined as AEs with onset on or after the time of initiation of study drug administration.|Up to 216 weeks|Safety Analysis Set: All participants who received at least 1 dose of study therapy.|||Participants|||Count of Participants
2600349|NCT02163577|Secondary|Serum Pre-Dose Concentrations of Burosumab||Week 40, 64, 160|PK/PD Analysis Set: all participants who received at least 1 dose of therapy and had evaluable serum data at given time point.|||ng/mL||Standard Deviation|Mean
2600350|NCT02163577|Secondary|Change From Baseline in BALP Over Time||Baseline, Week 40, 64, 160|PK/PD Analysis Set: all participants who received at least 1 dose of therapy and had evaluable serum data at given time point.|||mcg/L||Standard Deviation|Mean
2600351|NCT02163577|Secondary|Change From Baseline in ALP Over Time||Baseline, Week 40, 64, 160|PK/PD Analysis Set: all participants who received at least 1 dose of therapy and had evaluable serum data at given time point.|||U/L||Standard Deviation|Mean
2600352|NCT02163577|Secondary|Change From Baseline in CTx Over Time||Baseline, Week 40, 64|PK/PD Analysis Set: all participants who received at least 1 dose of therapy and had evaluable serum data at given time point.|||ng/mL||Standard Deviation|Mean
2600353|NCT02163577|Secondary|Change From Baseline in P1NP Over Time||Baseline, Week 40, 64|PK/PD Analysis Set: all participants who received at least 1 dose of therapy and had evaluable serum data at given time point.|||ng/mL||Standard Deviation|Mean
2600354|NCT02163577|Secondary|Change From Baseline in FEP Over Time|FEP is defined as 100% × (urine phosphorus × serum creatinine)/(urine creatinine × serum phosphorus), where the 2-hour urine sample was used for urine phosphorus and urine creatinine.|Baseline, Week 40, 64, 160|Safety Analysis Set: All participants who received at least 1 dose of study therapy and had an assessment at given time point.|||percentage of phosphorus excreted||Standard Deviation|Mean
2600355|NCT02163577|Secondary|Change From Baseline in POSNA-PODCI (Normative Score) Global Functioning Scale Scores Over Time|The POSNA-PODCI yields 4 functional assessment scores: Upper Extremity Function,Transfers and Basic Mobility, Sports and Physical Function, and Comfort/Pain. In addition, a Global Function score, which is an average of the 4 functional assessments, and a Happiness score are calculated. Raw, mean, standardized, and normative scores are calculated for each scale. Normative scores are calculated so that higher scores indicate better functioning. All scores are referenced to the general, healthy population with a normative mean score of 50 and a standard deviation of 10.|Baseline, Week 40, 64, 160|ITT Analysis Set: all participants who received at least 1 dose of study therapy and had at least 1 post-dose measurement at given time point.|||T-score||Standard Error|Least Squares Mean
2600356|NCT02163577|Secondary|Change From Baseline in POSNA-PODCI (Normative Score) Happiness Scale Scores Over Time|The POSNA-PODCI yields 4 functional assessment scores: Upper Extremity Function,Transfers and Basic Mobility, Sports and Physical Function, and Comfort/Pain. In addition, a Global Function score, which is an average of the 4 functional assessments, and a Happiness score are calculated. Raw, mean, standardized, and normative scores are calculated for each scale. Normative scores are calculated so that higher scores indicate better functioning. All scores are referenced to the general, healthy population with a normative mean score of 50 and a standard deviation of 10.|Baseline, Week 40, 64, 160|ITT Analysis Set: all participants who received at least 1 dose of study therapy and had at least 1 post-dose measurement at given time point.|||T-score||Standard Error|Least Squares Mean
2600357|NCT02163577|Secondary|Change From Baseline in POSNA-PODCI (Normative Score) Pain/Comfort Scale Scores Over Time|The POSNA-PODCI yields 4 functional assessment scores: Upper Extremity Function,Transfers and Basic Mobility, Sports and Physical Function, and Comfort/Pain. In addition, a Global Function score, which is an average of the 4 functional assessments, and a Happiness score are calculated. Raw, mean, standardized, and normative scores are calculated for each scale. Normative scores are calculated so that higher scores indicate better functioning. All scores are referenced to the general, healthy population with a normative mean score of 50 and a standard deviation of 10.|Baseline, Week 40, 64, 160|ITT Analysis Set: all participants who received at least 1 dose of study therapy and had at least 1 post-dose measurement at given time point.|||T-score||Standard Error|Least Squares Mean
2600387|NCT02163486|Secondary|Incidence of Post-operative Sore Throat|Patients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, voice loss and difficulty swallowing , at postoperative 1st and 24th hours.|at postoperative 1st and 24th hours||||participants|||Number
2600388|NCT02163486|Secondary|Ease of Placement|"Ease of placement:~no reaction~straining, retching"|Baseline||||participants|||Number
2600389|NCT02163486|Secondary|Number of Attempts|The number of attempts until succesful placement of airway device|Baseline to first successful ventilation,|The number of patients with succesful placement of airway device at the first attempt|||Participants|||Count of Participants
2600358|NCT02163577|Secondary|Change From Baseline in POSNA-PODCI (Normative Score) Sports/Physical Functioning Scale Scores Over Time|The POSNA-PODCI yields 4 functional assessment scores: Upper Extremity Function,Transfers and Basic Mobility, Sports and Physical Function, and Comfort/Pain. In addition, a Global Function score, which is an average of the 4 functional assessments, and a Happiness score are calculated. Raw, mean, standardized, and normative scores are calculated for each scale. Normative scores are calculated so that higher scores indicate better functioning. All scores are referenced to the general, healthy population with a normative mean score of 50 and a standard deviation of 10.|Baseline, Week 40, 64, 160|ITT Analysis Set: all participants who received at least 1 dose of study therapy and had at least 1 post-dose measurement at given time point.|||T-score||Standard Error|Least Squares Mean
2600359|NCT02163577|Secondary|Change From Baseline in POSNA-PODCI (Normative Score) Transfer and Basic Mobility Scale Scores Over Time|The POSNA-PODCI yields 4 functional assessment scores: Upper Extremity Function,Transfers and Basic Mobility, Sports and Physical Function, and Comfort/Pain. In addition, a Global Function score, which is an average of the 4 functional assessments, and a Happiness score are calculated. Raw, mean, standardized, and normative scores are calculated for each scale. Normative scores are calculated so that higher scores indicate better functioning. All scores are referenced to the general, healthy population with a normative mean score of 50 and a standard deviation of 10.|Baseline, Week 40, 64, 160|ITT Analysis Set: all participants who received at least 1 dose of study therapy and had at least 1 post-dose measurement at given time point.|||T-score||Standard Error|Least Squares Mean
2600360|NCT02163577|Secondary|Change From Baseline in POSNA-PODCI (Normative Score) Upper Extremity Scale Scores Over Time|The POSNA-PODCI yields 4 functional assessment scores: Upper Extremity Function,Transfers and Basic Mobility, Sports and Physical Function, and Comfort/Pain. In addition, a Global Function score, which is an average of the 4 functional assessments, and a Happiness score are calculated. Raw, mean, standardized, and normative scores are calculated for each scale. Normative scores are calculated so that higher scores indicate better functioning. All scores are referenced to the general, healthy population with a normative mean score of 50 and a standard deviation of 10.|Baseline, Week 40, 64, 160|ITT Analysis Set: all participants who received at least 1 dose of study therapy and had at least 1 post-dose measurement at given time point.|||T-score||Standard Error|Least Squares Mean
2600361|NCT02163577|Secondary|6MWT Distance (Predicted Percent of Normal) Change From Baseline Over Time|The total distance walked (meters) in a 6-minute period was measured. The percent of predicted values were calculated using published normative data based on age, gender, and height (Geiger et al. 2007).|Baseline, Week 40, 64, 160|ITT Analysis Set: all participants who received at least 1 dose of study therapy and had at least 1 post-dose measurement at given time point.|||percentage of predicted distance||Standard Error|Least Squares Mean
2600362|NCT02163577|Secondary|Change From Baseline in Growth (Leg Length) Over Time||Baseline, Week 40, 64, 160|ITT Analysis Set: all participants who received at least 1 dose of study therapy and had at least 1 post-dose measurement at given time point.|||cm||Standard Deviation|Mean
2600363|NCT02163577|Secondary|Change From Baseline in Growth (Arm Length) Over Time||Baseline, Week 40, 64, 160|ITT Analysis Set: all participants who received at least 1 dose of study therapy and had at least 1 post-dose measurement at given time point.|||cm||Standard Deviation|Mean
2600364|NCT02163577|Secondary|Change From Baseline in Growth (Sitting Height) Over Time||Baseline, Week 40, 64, 160|ITT Analysis Set: all participants who received at least 1 dose of study therapy and had at least 1 post-dose measurement at given time point.|||cm||Standard Deviation|Mean
2600365|NCT02163577|Secondary|Change From Baseline in Growth (Standing Height) Over Time||Baseline, Week 40, 64, 160|ITT Analysis Set: all participants who received at least 1 dose of study therapy and had at least 1 post-dose measurement at given time point.|||cm||Standard Deviation|Mean
2600366|NCT02163577|Secondary|Change From Baseline in Standing Height Z Score Over Time|Standing height Z scores are measures of height adjusted for a child's age and sex. The Z score indicates the number of standard deviations away from a reference population (from the CDC growth charts) in the same age range and with the same sex. A Z score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z scores indicate a better outcome.|Baseline, Week 40, 64, 160|ITT Analysis Set: all participants who received at least 1 dose of study therapy and had at least 1 post-dose measurement at given time point.|||Z score||Standard Error|Least Squares Mean
2600367|NCT02163577|Secondary|Change From Baseline in Growth Velocity Over Time||Baseline, Week 40, 64, 160|ITT Analysis Set: all participants who received at least 1 dose of study therapy and had at least 1 post-dose measurement at given time point.|||cm/year||Standard Deviation|Mean
2600368|NCT02163577|Secondary|RGI-C Wrist Scores Over Time|Changes in the severity of rickets and bowing were assessed centrally by three independent pediatric radiologists contracted by a central imaging facility using a disease specific qualitative RGI-C scoring system. The RGI-C is a seven point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets).|Baseline, Week 40, 64, 160|ITT Analysis Set: all participants who received at least 1 dose of study therapy and had at least 1 post-dose measurement at given time point.|||score on a scale||Standard Error|Least Squares Mean
2600369|NCT02163577|Secondary|RGI-C Knee Scores Over Time|Changes in the severity of rickets and bowing were assessed centrally by three independent pediatric radiologists contracted by a central imaging facility using a disease specific qualitative RGI-C scoring system. The RGI-C is a seven point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets).|Baseline, Week 40, 64, 160|ITT Analysis Set: all participants who received at least 1 dose of study therapy and had at least 1 post-dose measurement at given time point.|||score on a scale||Standard Error|Least Squares Mean
2600390|NCT02163486|Secondary|The Time for Successful Placement (Second)|Duration from mouth opening to first successful ventilation, in seconds|Baseline to first successful ventilation, in seconds||||seconds||Standard Deviation|Mean
2600370|NCT02163577|Secondary|Radiographic Global Impression of Change (RGI-C) Global Scores Over Time|Changes in the severity of rickets and bowing were assessed centrally by three independent pediatric radiologists contracted by a central imaging facility using a disease specific qualitative RGI-C scoring system. The RGI-C is a seven point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets).|Baseline, Week 40, 64, 160|ITT Analysis Set: all participants who received at least 1 dose of study therapy and had at least 1 post-dose measurement at given time point.|||score on a scale||Standard Error|Least Squares Mean
2600371|NCT02163577|Secondary|Change From Baseline in RSS Wrist Scores Over Time|The RSS system is a 10-point radiographic scoring method that was developed to assess the severity of nutritional rickets in the wrists and knees based on the degree of metaphyseal fraying, cupping, and the proportion of the growth plate affected. Scores are assigned for the unilateral wrist and knee X-rays deemed by the rater to be the more severe of the bilateral images. The maximum total score on the RSS is 10 points and the minimum score is 0, with a total possible score of 4 points for the wrists and 6 points for the knees. Higher scores indicate greater rickets severity.|Baseline, Week 40, 64, 160|ITT Analysis Set: all participants who received at least 1 dose of study therapy and had at least 1 post-dose measurement at given time point.|||score on a scale||Standard Error|Least Squares Mean
2600372|NCT02163577|Secondary|Change From Baseline in RSS Knee Scores Over Time|The RSS system is a 10-point radiographic scoring method that was developed to assess the severity of nutritional rickets in the wrists and knees based on the degree of metaphyseal fraying, cupping, and the proportion of the growth plate affected. Scores are assigned for the unilateral wrist and knee X-rays deemed by the rater to be the more severe of the bilateral images. The maximum total score on the RSS is 10 points and the minimum score is 0, with a total possible score of 4 points for the wrists and 6 points for the knees. Higher scores indicate greater rickets severity.|Baseline, Week 40, 64, 160|ITT Analysis Set: all participants who received at least 1 dose of study therapy and had at least 1 post-dose measurement at given time point.|||score on a scale||Standard Error|Least Squares Mean
2600373|NCT02163577|Primary|Change From Baseline in TmP/GFR Over Time|Data for urinary phosphorus and TRP were used in calculation TmP/GFR.|Baseline, Week 40, 64, 160|PK/PD Analysis Set: all participants who received at least 1 dose of therapy and had evaluable serum data at given time point.|||mg/dL||Standard Deviation|Mean
2600374|NCT02163577|Primary|Change From Baseline in Serum 1,25(OH)2D Over Time||Baseline, Week 40, 64, 160|PK/PD Analysis Set: all participants who received at least 1 dose of therapy and had evaluable serum data at given time point.|||pg/mL||Standard Deviation|Mean
2600375|NCT02163577|Primary|Change From Baseline in Serum Phosphorus Over Time||Baseline, Week 40, 64, 160|Pharmacokinetic/Pharamcodynamic (PK/PD) Analysis Set: all participants who received at least 1 dose of therapy and had evaluable serum data at given time point.|||mg/dL||Standard Deviation|Mean
2600376|NCT02163577|Primary|Change From Baseline in RSS Total Score Over Time|The RSS system is a 10-point radiographic scoring method that was developed to assess the severity of nutritional rickets in the wrists and knees based on the degree of metaphyseal fraying, cupping, and the proportion of the growth plate affected. Scores are assigned for the unilateral wrist and knee X-rays deemed by the rater to be the more severe of the bilateral images. The maximum total score on the RSS is 10 points and the minimum score is 0, with a total possible score of 4 points for the wrists and 6 points for the knees. Higher scores indicate greater rickets severity.|Baseline, Week 40, 64, 160|Intent to Treat (ITT) Analysis Set: all participants who received at least 1 dose of study therapy and had at least 1 post-dose measurement at given time point.|||score on a scale||Standard Error|Least Squares Mean
2600377|NCT02163538|Secondary|Time Required to Complete Procedure||End of surgery up to 4 hours||||Minutes||Inter-Quartile Range|Median
2600378|NCT02163538|Secondary|Time From Port Placement to Bilateral Uterine Artery Ligation and Hemostatsis.||During procedure||||minutes||Inter-Quartile Range|Median
2600379|NCT02163538|Secondary|Need for Second Energy Device Intra-operatively||18 months||||Participants|||Count of Participants
2600380|NCT02163538|Secondary|Estimated Blood Loss||18 months||||mL||Inter-Quartile Range|Median
2600381|NCT02163538|Secondary|Intra- and Post-operative Complications||18 months||||Participants|||Count of Participants
2600382|NCT02163538|Primary|Raw Task Load Index (TLX) Score Assigned by Surgeons|"The Official NASA Task Load Index (TLX) is a subjective workload assessment tool to allow users to perform subjective workload assessments on operator(s) working with various human-machine interface systems. By incorporating a multi-dimensional rating procedure, NASA TLX derives an overall workload score based on a weighted average of ratings on six subscales given below. The overall workload score ranges between 0 and 100 with 100 being the most demanding.~Mental Demand Physical Demand Temporal Demand Performance Effort Frustration"|18 months||||units on a scale||Inter-Quartile Range|Median
2600383|NCT02163499|Primary|Percentage of Participants With Mean S-K Values ≤ 5.1 mmol/L During Extended Dosing Phase Days 85 to 365|Percentage of subjects with mean S-K values ≤ 5.1 mmol/L during Extended Dosing Phase - ITT Population|Study Days 85 to 365|"The Extended Phase Intent To Treat populations (EP-ITT) included subjects who received at least one dose of ZS in the EP and have at least one S-K assessment after administration of Extended Phase ZS.~Efficacy: Separate analyses were performed for the Acute and Extended Dosing Phases."|||Percentage of participants||95% Confidence Interval|Number
2600384|NCT02163499|Primary|Percent of Participants With Restoration of Normal Serum Potassium (S-K) Values (3.5 to 5.0 mmol/L, Inclusive) at the End of the Acute Phase|Percentage of subjects with S-K values between 3.5 and 5.0 mmol/L, inclusive at the end of the Acute Phase - ITT Population|72 Hours|"The Intent To Treat populations for the Acute Phase (AP-ITT) included subjects who received at least one dose of ZS with at least one S-K assessment after administration of Acute Phase ZS.~Efficacy: Separate analyses were performed for the Acute and Extended Dosing Phases."|||Percentage of participants||95% Confidence Interval|Number
2600385|NCT02163499|Secondary|Mean S-K Levels Months 3 to 12, Months 6 to 9, and Months 9 to 12.|Mean S-K levels months 3 to 12(EP Days 85, 113, 141, 176, 211, 239, 267, 295, 330, 365 and EOS),months 6 to 9, and months 9 to 12.|Study days 85 to 365|Extended phase ITT population|||mmol/L||Standard Deviation|Mean
2600391|NCT02163486|Primary|Oropharyngeal Leak Pressure|The aim of this study is to compare the effect of different head and neck positions on the oropharyngeal leak pressure in LMA-Unique and I-Gel applications. Head and neck positions are limited to neutral, extension and right laterally deviated.|Immediately after head and neck positioning is completed||||cm H20||Standard Deviation|Mean
2600392|NCT02163447|Secondary|Prevalence of Parasitemia at the Time of Monthly Routine Visits During Pregnancy|Detection of malaria parasites by LAMP during pregnancy|After first dose of study drug through delivery or early termination||||LAMP measurement|LAMP measurement||Number
2600393|NCT02163447|Secondary|Prevalence of Parasitemia in Infants|Proportion of routine monthly samples positive for parasites by LAMP. Proportion of routine samples (LAMP or blood smears) positive for asexual parasites.|Birth up to 24 months of age or early study termination||2018-10-31|10/2018||||
2600394|NCT02163447|Secondary|Prevalence of Gametocytemia in Pregnant Women and Infants|Proportion of routine blood smears positive for gametocytes|Women: Gestational age between 12-20 weeks (at study entry) up to delivery; Infants: Birth up to 24 months of age or early study termination|||||||
2600395|NCT02163447|Secondary|Incidence of Hospital Admissions in Infants|Admission to a hospital for pediatric inpatient care for any reason|Birth up to 24 months of age or early study termination|||||||
2600396|NCT02163447|Secondary|Incidence of Complicated Malaria in Infants|Any treatment for malaria meeting criteria for severe malaria or danger signs|Birth up to 24 months of age or early study termination|||||||
2600397|NCT02163447|Secondary|Prevalence of Anemia in Pregnant Women|Prevalence of routine hemoglobin measurements < 11 g/dL|After first dose of study drugs up to delivery or early termination||||hemoglobin measurements taken every 12wk|hemoglobin measurements taken every 12wk||Number
2600398|NCT02163447|Secondary|Number of Participants With One or More Birth Outcomes: Congenital Malformations, Spontaneous Abortion, LBW (<2500g), Still Birth, Pre-term Delivery|Congenital malformations, spontaneous abortion, LBW (<2500g), still birth, pre-term delivery|Delivery||||Participants|||Count of Participants
2600399|NCT02163447|Secondary|Number of Participants With Maternal Blood Samples Positive for Parasites by Microscopy and LAMP at Delivery|Prevalence of maternal parasitemia at delivery by microscopy and LAMP|At delivery|One observation in the monthly DP arm did not have results for microscopy; this outcome measure tests blood taken from the mother's arm (different from outcome measure 4 which tests blood taken from the placenta)|||participants|||Number
2600400|NCT02163447|Secondary|Number of Participants With Blood Samples Positive for Parasites by Microscopy or LAMP|Prevalence of placental blood samples positive for parasites by microscopy or LAMP|Delivery||||Participants|||Count of Participants
2600401|NCT02163447|Primary|Incidence of Malaria in Infants|Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days. The study investigators will test the hypotheses that A) infants born to mothers randomized to receive IPTp with 3 dose DP or monthly DP will have a lower incidence of malaria during the first 24 months of life compared to infants born to mothers who were randomized to receive IPTp with 3 doses of SP, and, B) infants randomized to receive monthly DP between 2-24 months of age will have a lower incidence of malaria between 24-36 months of age after the intervention is stopped compared to infants randomized q 3 monthly DP between 2-24 months of age.|Time at risk will begin at birth and will end when study participants reaches 24 months of age or early study termination (if prior to 24 months of age) and at 24 months of age and will end when study participants reaches 36 months of age or termination|||||||
2600402|NCT02163447|Primary|Incidence of Malaria in Pregnant Women|Incidence of malaria, defined as the number of incident episodes per time at risk. Incident cases will include all treatments for malaria not proceeded by another treatment in the previous 14 days.|Time at risk will begin after first dose of study drug and will end when study participants deliver or early study termination||||events per person years|||Number
2600403|NCT02163447|Primary|Prevalence of Placental Malaria|Prevalence of placental malaria based on placental histopathology dichotomized into any evidence of placental infection (parasites or pigment) vs. no evidence and by histopathology as a categorical variable based on Rogerson et al criteria.|Delivery|Only women who delivered and had histopathology results were analyzed. 2 women in 3 Dose SP and 1 woman in monthly DP arms completed the study but did not have histopathology results.|||Participants|||Count of Participants
2600404|NCT02163421|Primary|Population Mean Estimate for Bioavailability Following Subcutaneous (SC) Administration|Bioavailability is defined as the rate and extent to which the active moiety of the e.g. subcutaneous administered drug reaches the systemic circulation. Population mean estimate for bioavailability was based on population pharmacokinetic (PK) analysis to find one measure. The exposure data were pooled across visits and subjects to identify population PK parameter estimates and covariate effects. The outcome measure data was planned to be analyzed using a model collating all arms measures to report pooled data across arms, as per planned analysis. Bioavailability was estimated using population pharmacokinetic (popPK) analysis.|Day 1: predose and on multiple time points (up to Day 127)|The pharmacokinetic analysis set included all randomized participants who received study treatment and who had at least 1 measurable pharmacokinetic concentration.|||percentage of drug||95% Confidence Interval|Number
2600405|NCT02163395|Secondary|The Implant Survival|A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.|Measured at Week 26, Month 24 and Month 36|Implant survival rates provided for the patients of the ITT population, who had valid data. Missing data were not imputed.|||percentage of participants||95% Confidence Interval|Number
2600406|NCT02163395|Secondary|Mean Bone Level Changes (Distal and Mesial)|A radiographic stent was produced to have a standard measurement. The distal and mesial bone levels were combined into a single value by averaging the two values. Negative bone level changes representing bone loss between baseline and follow-up visits, vice versa positive changes representing bone gain.|Measured at Week 26, Month 12, Month 24 and Month 36|Standardised bone level measurements provided for the ITT population. Missing data were not imputed.|||mm||Standard Deviation|Mean
2600431|NCT02162667|Secondary|Overall Survival|Overall survival was defined as the interval between randomization and death from any cause.|Up to 3 years from the day of last patient enrollment (during whole study period)|Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.|||proportion of participants||95% Confidence Interval|Number
2600407|NCT02163395|Secondary|The Implant Success|"According to Buser et al 1992 an implant will be deemed a success if all of the following success criteria apply.~Absence of persisting subjective discomfort such as pain, foreign body perception and or dysaesthesia (painful sensation)~Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics)~Absence of implant mobility on manual palpation~Absence of any continuous peri-implant radiolucency"|Measured at Week 26, Month 12, Month 24 and Month 36|Implant success rates provided for the patients of the ITT population, who had valid data. Missing data were not imputed.|||percentage of participants||95% Confidence Interval|Number
2600408|NCT02163395|Primary|The Implant Survival|A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.|Measured at 12 months +/- 4 weeks after implant placement|Implant survival rates provided for the patients of the ITT population, who had valid data. Missing data were not imputed.|||percentage of participants||95% Confidence Interval|Number
2600409|NCT02163187|Secondary|Quality of Life|QOL and urinary continence will be assessed at the start of the study (Baseline), after initial stimulation (Step 1-Wire Stimulation), and at each point in the crossover trial (Step 2-Implantation and Step 3-Crossover). Graphical displays will be used to explore data distributions of all secondary outcome measures over time. We assume no period effect and will evaluate the treatment effect using the paired t-test (and a repeated measures ANOVA to include other covariates in the model) for each of our main outcome measures, EuroQOL5, FIQOL, LARS and Bladder function. We will test for period effect to confirm this.|3 years|Study terminated early due to low accrual. Data were not collected.||||||
2600410|NCT02163187|Primary|Change in Bowel Function|Bowel function will be assessed by using the MSK BFI. We have chosen the BFI because it is widely endorsed to assess the clinical problem that these patients have. The BFI is a 19 item instrument to which a patient responds using a 5-point Likert scale, ranging from Always to Never.|3 years|Study terminated early due to low accrual. Data were not collected.||||||
2600411|NCT02162992|Secondary|QT and Corrected QT Intervals|Ventricular repolarization will be evaluated by 12-lead ECG recordings an 24-hour Holter recordings. Measurements will include QT and corrected QT intervals, and the presence of ventricular arrhythmia. Corrected QT (QTc) intervals will be obtained by measuring the QT interval (QTm) and the previous RR interval, following the Bazett formula (QTc=QTm divided by the square root of previous RR interval in seconds). A comparison will be made between the anti-Ro60 antibody positive patients and the anti-Ro60 antibody negative patients.|24 hours||||msec||Standard Deviation|Mean
2600412|NCT02162992|Primary|Presence of Conduction Disorders in Patients With SLE Regarding to Its Serologic Profile|Conduction disorders will be evaluated by 12-lead ECG recordings an 24-hour Holter recordings. Measurements will include PR intervals (in msec), QRS duration (in msec) .|24 hours||||msec||Standard Deviation|Mean
2600413|NCT02162979|Secondary|Change in Dose of Anti-parkinsonian Medications||7 weeks|||||||
2600414|NCT02162979|Secondary|"Percent Change in on Time"|"on time is the period in which the subject is symptom free. We will track the amount of time the subject is considered symptom free before and after treatment. This value will be represented as a percent change."|4 weeks|||||||
2600415|NCT02162979|Primary|Change in Duration of Dyskinesia.||2 weeks|||||||
2600416|NCT02162862|Primary|Change in Baseline in Pittsburgh Sleep Quality Index (PSQI) for Each Arm|PSQI score range is 0-21 with higher score indicating greater sleep disturbance.|Baseline (week 0) to end of study (week 14)||||units on a scale||Standard Deviation|Mean
2600417|NCT02162862|Primary|Change From Baseline in Multidimensional Fatigue Inventory (MFI) for Each Arm|MFI score range is 0-100. Higher score indicates higher level of fatigue.|Baseline (week 0) to end of study (week 14)||||units on a scale||Standard Deviation|Mean
2600418|NCT02162771|Secondary|B-cell Kinetics (B-cell Depletion and Recovery)|B-cell kinetics were demonstrated by median values of B-cell counts (Lower limit of quantification was 20 cells/uL).|Cycles 1 to 8 during the Core Study Period|Pharmacodynamic (PD) population consisted of all patients who had at least 1 posttreatment PD result after receiving at least 1 dose of study drug (CT-P10 or Rituxan) without any major protocol deviation that was relevant to the PD endpoint in Part 2.|||cells/uL||Full Range|Median
2600419|NCT02162771|Primary|Overall Response Rate (ORR) According to the 1999 International Working Group (IWG) Criteria|"ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed complete response (CRu), or partial response (PR) by central review.~Per 1999 IWG criteria, the disease status was assessed by using contrasted CT, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: >=75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: >=50% decrease in SPD of target lesions and no evidence of disease progression."|During the Core Study Period (up to 8 cycles; Week 24)|Efficacy population consisted of all patients who had at least 1 response evaluation after receiving at least 1 treatment cycle in the Core Study Period without any major protocol deviation that was relevant to the efficacy endpoint in Part 2.|||Participants|||Count of Participants
2600420|NCT02162771|Primary|Maximum Serum Concentration at Steady State (Cmax,ss)|"Cmax,ss: Maximum concentration of drug in plasma at steady state on administering a fixed dose at equal dosing intervals.~PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained."|Core Cycle 4 (Week 12)|Pharmacokinetic Population consisted of all patients who had at least 1 posttreatment PK concentration result after receiving at least 1 dose of study drug (CT-P10 or Rituxan) in Part 1. Patients considered outliers identified by a robust regression model (95% CI) were excluded from the analysis.|||ug/mL||Standard Error|Geometric Mean
2600490|NCT02161575|Secondary|Change in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA was assessed as letters read and measured in a sitting position using subjective refraction and Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.|Baseline, Day 90 and Day 180|FAS|||letters||Full Range|Median
2600421|NCT02162771|Primary|Area Under the Serum Concentration-time Curve at Steady State (AUCtau)|"AUCtau: Area under the plasma drug concentration-time curve within a dosing interval at steady state.~PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained."|Core Cycle 4 (Week 12)|Pharmacokinetic Population consisted of all patients who had at least 1 posttreatment PK concentration result after receiving at least 1 dose of study drug (CT-P10 or Rituxan) in Part 1. Patients considered outliers identified by a robust regression model (95% CI) were excluded from the analysis.|||h*ug/mL||Standard Error|Geometric Mean
2600422|NCT02162758|Secondary|Change From Baseline in the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Total Score|The GERD-HRQL score consisted of 10 questions, where participants were required to answer each question on a scale of 0 to 5 (0: no symptoms; 1: symptoms noticeable but not bothersome; 2: symptoms noticeable and bothersome but not every day; 3: symptoms bothersome every day; 4: symptoms affect daily activity; 5: symptoms are incapacitating to do daily activities). The total score was derived by simply adding the individual score of each question. The total score ranged from 0 to 50 where a higher score indicated more severe disease. The best possible total GERD-HRQL score was 0 (asymptomatic in all questions) and the worst possible score is 50 (incapacitated in all questions).|Baseline and Month 12|The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.|||units on scale||Standard Deviation|Mean
2600423|NCT02162758|Secondary|Percentage of Participants With Erosive Esophagitis (EE)|The severity of EE was classified into following grades: Grade A: one or more mucosal breaks no longer than 5 millimeter (mm), none of which extends between the tops of the mucosal folds; Grade B: one or more mucosal breaks more than 5 mm long, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve less than 75 percent (%) of the esophageal circumference; Grade D: mucosal breaks which involve at least 75% of the esophageal circumference.|Baseline up to Month 12|The ITT population where EE assessment was available. The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.|||percentage of participants|||Number
2600424|NCT02162758|Secondary|Percentage of Participants With Recurrence of IM With Dysplasia|Recurrence of IM with dysplasia was defined as an esophageal biopsy result indicating BE with dysplasia.|Month 12|The ITT population where Month 12 esophageal biopsy assessment was available. The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.|||percentage of participants|||Number
2600425|NCT02162758|Primary|Percentage of Participants With Recurrence of Intestinal Metaplasia (IM)|Recurrence of IM was defined as an esophageal biopsy result indicating BE with or without dysplasia.|Month 12|The Intent-to-treat (ITT) population where Month 12 esophageal biopsy assessment was available. The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.|||percentage of participants|||Number
2600426|NCT02162680|Primary|Differences in Patients' Perceptions of Pain Between Treatment Methods|The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. The visual analog pain score will be completed at the following time points: pre injection, during injection, and during catheter insertion.|at pre injection, during anesthetic injection, and during catheter insertion, up to approximately 1 minute||||units on a scale||Standard Deviation|Mean
2600427|NCT02162667|Post-Hoc|The Percentage of Patients Achieving Pathological Complete Response of the Breast and Axillary Nodes Regardless of DCIS|"Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.~The secondary endpoint, other than pCR of breast and axillary nodes ragardless of DCIS which was primary endpoint, will be assessed using resected bio-specimens collected in breast and axilla during a surgery."|After Neo-adjuvant therapy and Surgery (up to 30 weeks)|Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.|||percentage of responders||95% Confidence Interval|Number
2600428|NCT02162667|Secondary|Trough Serum Concentration (Ctrough) in Each Cycle|Pharmacokinetic samples were collected before study drug (CT-P6 or US-licensed Herceptin) administration (within 15 minutes prior to the beginning of the study drug infusion) and within 15 minutes after the end of the study drug infusion for each cycle during the Neoadjuvant Period. After the completion of treatment, an additional PK sample was collected at the EOT1.|Pre-infusion of cycles 1 to 8 during neoadjuvant period|Safety Analysis Set: All patients randomly assigned to study drug and who receive at least 1 dose (fully or partially) of study drug|||µg/mL||Standard Deviation|Mean
2600429|NCT02162667|Secondary|Maximum Serum Concentration After Administration (Cmax) in Each Cycle|Pharmacokinetic samples were collected before study drug (CT-P6 or US-licensed Herceptin) administration (within 15 minutes prior to the beginning of the study drug infusion) and within 15 minutes after the end of the study drug infusion for each cycle during the Neoadjuvant Period. After the completion of treatment, an additional PK sample was collected at the EOT1.|End of each treatment cycles, up to 24 weeks (during neoadjuvant period)|Safety Analysis Set: All patients randomly assigned to study drug and who receive at least 1 dose (fully or partially) of study drug|||µg/mL||Standard Deviation|Mean
2600430|NCT02162667|Secondary|The Number of Patients Who Had Progressive Disease or Recurrence|"If recurrence or progression of disease occurred at any time during the study, the progressed tumor site was recorded in the recurrence or progression of disease eCRF page as local, regional, or distant, with diagnostic method and whether positive cytology or histology or not.~The resulting recurrence or progression of disease information was summarized as secondary endpoint."|Up to 3 years from the day of last patient enrollment (during whole study period)|Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.|||participants|||Number
2618709|NCT01969214|Secondary|Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint)||72 hours||||Percentage of subjects|||Number
2600432|NCT02162667|Secondary|Progression-Free Survival|Progression-free survival was defined as the interval between randomization and disease progression, recurrence, or death from any cause, whichever occurred first. Only a recurrence or progression of disease that occurred before beginning another anticancer therapy was regarded as an event.|Up to 3 years from the day of last patient enrollment (during whole study period)|Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.|||proportion of participants||95% Confidence Interval|Number
2600433|NCT02162667|Secondary|Disease-free Survival|Patients who underwent breast surgery were included in the DFS analysis. Disease-free survival was defined as the interval between the date of breast surgery and disease progression, recurrence, or death from any cause, whichever occurred first. Only a recurrence or progression of disease that occurred before beginning another anticancer therapy was regarded as an event.|Up to 3 years from the day of last patient enrollment (during whole study period)|Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.|||proportion of participants||95% Confidence Interval|Number
2600434|NCT02162667|Secondary|Overall Response Rate (ORR) From Local Review|The ORR was defined as the proportion of patients with a BOR of CR or PR as assessed by RECIST guideline Version 1.1 during the Nedadjuvant Period.|After Neo-adjuvant therapy (up to 24 weeks)|Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.|||percentage of responders||95% Confidence Interval|Number
2600435|NCT02162667|Secondary|The Percentage of Patients Achieving Pathological Complete Response of the Breast and Axillary Nodes With Absence of DCIS|"Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.~The secondary endpoint, other than pCR of breast and axillary nodes ragardless of DCIS which was primary endpoint, will be assessed using resected bio-specimens collected in breast and axilla during a surgery."|After Neo-adjuvant therapy and Surgery (up to 30 weeks)|Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.|||percentage of responders||95% Confidence Interval|Number
2600436|NCT02162667|Secondary|The Percentage of Patients Achieving Pathological Complete Response (pCR) of the Breast Regardless of DCIS With Positive or Unknown Nodal Status|"Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.~The secondary endpoint, other than pCR of breast and axillary nodes ragardless of DCIS which was primary endpoint, will be assessed using resected bio-specimens collected in breast and axilla during a surgery."|After Neo-adjuvant therapy and Surgery (up to 30 weeks)|Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.|||percentage of responders||95% Confidence Interval|Number
2600437|NCT02162667|Primary|The Percentage of Patients Achieving Pathological Complete Response Defined as the Absence of Invasion Tumor Cells in the Breast and in Axillary Lymph Nodes, Regardless of Ductal Carcinoma in Situ (DCIS)|"Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.~The primary endpoint, Pathological complete response, will be assessed using resected bio-specimens collected in breast and axilla during a surgery."|After Neo-adjuvant therapy and Surgery (up to 30 weeks)|Per-Protocol Set: All patients randomly assigned to study drug, regardless of whether or not any study treatment dosing is completed, except for those patients excluded because of major protocol deviations.|||percentage of responders||95% Confidence Interval|Number
2600438|NCT02162576|Secondary|Percent Change in the Proportion of Participants With Well-controlled Asthma|Daily control status was assessed based upon the timing and frequency of SABA actuations according to NAEPP guidelines. The proportion of the study cohort defined as well controlled, not well controlled and poorly controlled was assessed weekly throughout the program.|Baseline and study exit (approximately 13 months)||||percent change|||Number
2600439|NCT02162576|Secondary|Percent Change in the Proportion of Participants With an Asthma-free Day|Each 24-hour period without an actuation of a rescue inhaler was counted as an asthma-free day. The proportion of participants with an asthma-free day was calculated for each day of the program, with the denominator including all active participants on that day of the program, defined as those that synced after that date.|Change from baseline period to study exit (approximately 13 months)||||percentage change|||Number
2600440|NCT02162576|Primary|Change in Rescue Inhaler Actuations/Person/Day|The Propeller Health sensor permits the capture of objective time and location data on each actuation of the rescue inhaler. The mean number of rescue inhaler events per participant per day will be assessed for each day in the study, and the difference between the baseline month and all subsequent months will be evaluated.|Change from baseline to study exit, up to 13 months||||puffs per participant per day||Standard Deviation|Mean
2600441|NCT02162446|Secondary|Best Diagnostic Scan Assessment|The assessment of every diagnostic 68Ga-OPS202 PET/CT scan of session 2 was rated by the reader from 1 to 5, where 1=worst diagnostic scan and 5=best diagnostic scan. Higher score indicates a better scan.|At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21|The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.|||score on a scale||Full Range|Median
2600442|NCT02162446|Secondary|Number of Participants at Each Time Point With the Highest Mean 3D-SUV-R Tumor Value|The time point with the highest mean 3D-SUV-R per tissue location were determined. If the highest mean 3D-SUV-R was detected at more than one time point, the earliest time point was used.|At 0.5, 1, 2, and 4 hour post-injection on Day 0|The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.|||Participants|||Count of Participants
2600491|NCT02161575|Secondary|Change in Maximum IRC Height From Baseline to Day 180|Change from Baseline to Day 180 in Maximum Intraretinal Cyst (IRC) Height. Data collected on the study eye were used for the evaluation of efficacy.|Baseline and Day 180|FAS|||micrometer||Full Range|Median
2600443|NCT02162446|Secondary|Number of Participants at Each Time Point With the Highest Observed Lesion Number Per Tissue Location|For determining a suitable time window for PET/CT with 68Ga-OPS202, the scans after administration of the 15 μg peptide dose were analyzed and the time point with the highest lesion number per tissue location and overall were determined. If the highest number of lesion was detected at more than one time point, the earliest time point was used.|At 0.5, 1, 2, and 4 hour post-injection on Day 0|The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.|||Participants|||Count of Participants
2600444|NCT02162446|Secondary|Percent Change in 3D-SUV-R of Malignant Lesions|The tumor contrast, i.e. the SUV ratio for 3D-SUV-R of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RT. For percent change, 68Ga-OPS202 receptor scan is compared to previous somatostatin receptor scan.|6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21|The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.|||percent change||Standard Deviation|Mean
2600445|NCT02162446|Secondary|The 3D-SUV-R of Malignant Lesions for Session 2|The tumor contrast, i.e. the SUV ratio for 3D-SUV-R of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RTs. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.|At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21|The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.|||ratio||Standard Deviation|Mean
2600446|NCT02162446|Secondary|Mean Tumor Contrast (3D-SUV-R) of Malignant Lesions Compared to Pre-dose Scans for Session 1|The tumor contrast, i.e. the SUV ratio for tumor (malignant lesion)-to-background (3D-SUV-R) of a single lesion was defined as: 3D-SUV-R = SUVmax of lesion / mean of SUVmax of corresponding RTs. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.|6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21|The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.|||ratio||Standard Deviation|Mean
2600447|NCT02162446|Secondary|Mean SUVmax of RT for Session 2|The mean SUVmax of all selected ROIs in the corresponding RT was determined. RTs were determined in tissue locations with malignant lesions only. ROIs were also selected in muscle tissue, which was used as an additional reference region. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.|At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21|The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.|||SUVmax||Standard Deviation|Mean
2600448|NCT02162446|Secondary|Mean SUVmax of Reference Tissues (RT) Region of Interests (ROIs) for Session 1|Lesion matching was performed between somatostatin receptor scan and 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. Mean SUVmax of all selected ROIs in corresponding RT was determined. Corresponding RTs were adjacent healthy regions (1 to 3 healthy regions were identified for each lesion), i.e. located in same organ and/or region as lesion. RTs were determined in tissue locations with malignant lesions only. ROIs were also selected in muscle tissue, which was used as an additional reference region. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.|6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21|The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.|||SUVmax||Standard Deviation|Mean
2600449|NCT02162446|Secondary|Mean SUVmax of Malignant and Benign Lesions for Session 2|The mean SUVmax of all identified lesions in the respective organ/tissue was determined. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.|At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21|The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.|||SUVmax||Standard Deviation|Mean
2600450|NCT02162446|Secondary|Mean Maximum Standardized Uptake Value (SUVmax) of Malignant and Benign Lesions for Session 1|At visit 1, after administration of 15 μg 68Ga-OPS202, a dynamic scan was performed in kidney region over the first 30 minutes (0-0.5 h); static scans were performed from head to sub-inguinal region at 0.5, 1, 2 and 4 h post-injection. At visit 2, after administration of 50 μg 68Ga-OPS202, a static scan was performed from head to sub-inguinal region at 1 h post-injection. A previous somatostatin receptor scan had been performed within 6 months prior to Day 0. Lesions were classified into malignant and benign lesion by the readers according to their experience. Lesion matching was performed between the somatostatin receptor scan and the 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. The mean SUVmax of lesions (mean of all identified lesions in the lymph node and liver) was summarized by nature of the lesions (malignant, benign). Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.|6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21|The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.|||SUVmax||Standard Deviation|Mean
2600451|NCT02162446|Secondary|Percentage of Participants With Lesion-Associated 68Ga-OPS202 Binding|Tumor contrast in PET imaging was determined by qualitative visual analysis. 68Ga-OPS202 binding was present if at least one lesion, regardless of nature, was detected within respective tissue location. Percentages were based on number of participants with available scan at corresponding time point.|At 0.5, 1, 2, and 4 hour post-injection on Day 0 and 1 hour post-injection on Day 21|The ITT set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.|||percentage of participants|||Number
2600452|NCT02162446|Secondary|Number of Malignant and Benign Lesions Detected for Session 1|At visit 1, after administration of 15 μg 68Ga-OPS202, a dynamic scan was performed in kidney region over first 30 minutes; static scans were performed from head to sub-inguinal region at 0.5, 1, 2 and 4 h post-injection. At visit 2, after administration of 50 μg 68Ga-OPS202, a static scan was performed from head to sub-inguinal region at 1 h post-injection. A previous somatostatin receptor scan had been performed within 6 months prior to Day 0. Lesions were classified into malignant and benign by readers. Lesion matching was performed between somatostatin receptor scan and 1 h-68Ga-OPS202 receptor scans at visit 1 and visit 2. Number of lesions for each organ/tissue and overall were calculated and absolute numbers reported. Two different read sessions were held to generate data sets for evaluation of target variables. Statistical comparisons were only feasible for those organs/ tissues that had sufficient participants with lesions detected.|6 months prior to Day 0; and 1 hour post-injection on Day 0 and Day 21|The Intention-to-Treat (ITT) set included all participants of the FAS who received the IP and had at least 1 evaluable PET/CT scan image available for at least 1 time point at visit 1 (Day 0) or visit 2 (Day 21), regardless of any protocol deviations.|||lesion||Standard Deviation|Mean
2600453|NCT02162446|Primary|Number of Participants With Clinical Significant Abnormalities in Laboratory Parameters, Vital Signs, Cardiac Safety, Physical Examination, and Required Concomitant Medication|Laboratory assessments included hematology, blood biochemistry and urine analysis. Vital signs included systolic and diastolic blood pressure, heart rate and axillary body temperature. Cardiac safety was assessed by 12-lead ECGs and physical examination included general appearance, head, neck, eyes, ears, nose, throat, respiratory, cardiovascular, gastrointestinal, musculoskeletal, neurological, endocrine, lymphatic, dermatological, psychological/psychiatric, abdomen, and genitourinary body systems. All medications (including herbal products) taken from visit 1 (Day 0) to visit 3 (7-15 days after visit 2 (3-4 weeks after visit 1), end of the study) were recorded in the participant's case report form.|From start of IP administration to end of the study visit (approximately 28 to 36 days)|The SAF included all participants of the FAS who received the investigational product, regardless of any protocol deviations.|||Participants|||Count of Participants
2600454|NCT02162446|Primary|Number of Participants Reported With Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Drug Reactions (ADRs)|An AE was defined as any untoward medical occurrence in a participant administered a IP and which does not necessarily have a causal relationship with this treatment. For this study, all AEs were regarded as 'treatment emergent', i.e., not seen before administration of the IP or, if already present before administration, worsened after start of administration. An SAE was defined as an event that led to death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect. An ADR was defined as an AE with probable, possible or unlikely relationship to the administration of 68Ga-OPS202.|From start of IP administration to end of the study visit (approximately 28 to 36 days)|The SAF included all participants of the FAS who received the IP, regardless of any protocol deviations.|||Participants|||Count of Participants
2600455|NCT02162433|Secondary|Number of Patients With Unplanned Hospital Admission|Any unplanned hospital admission due to perioperative respiratory adverse events.|24 hours||||Participants|||Count of Participants
2600456|NCT02162433|Secondary|Number of Participants Needing Follow-up Pain Medication|24-hour postoperative pain medication requirement assessed by a parental questionnaire administered 24 hours after discharge. The parents are asked whether their child took any pain medication within the last 24 hours since the surgery.|24 hours||||Participants|||Count of Participants
2600457|NCT02162433|Secondary|The Average Time From Admission to the PACU to Discharge Home (Excluding Overnight Admission)||24 hrs||||Minutes||Standard Deviation|Mean
2600458|NCT02162433|Secondary|Average Time From End of Surgery to Leaving the Operating Room||24 hours||||Minutes||Standard Deviation|Mean
2600459|NCT02162433|Secondary|Number of Participants With Postoperative Nausea and Vomiting (PONV)|Number of patients who experienced postoperative nausea and vomiting (PONV) as noted by the parental questionnaire administered 24 hours after the patient is discharged.|24 hrs||||Participants|||Count of Participants
2600460|NCT02162433|Secondary|Number of Participants With Emergence Agitation|"Number of patients with an incidence of emergence agitation post-surgery defined by the Pediatric Anesthesia Emergence Delirium (PAED) scale of >10.~Emergence agitation is characterized by non-purposeful movement, restlessness, thrashing, incoherence, inconsolability, and unresponsiveness. The PAED is a scale used to assess emergence agitation in our patient population. It's minimum value is zero and maximum value is 20, with 0 being no emergence agitation and 20 being the most agitated state."|24 hours||||Participants|||Count of Participants
2600461|NCT02162433|Primary|Number of Participants With Respiratory Complications|"Number of patients exhibiting any of the following outcomes:~desaturation to less than 95% for more than 10 seconds;~breath holding;~complete or partial laryngospasm;~bronchospasm;~croup;~number of episodes of persistent cough (three or more consecutive coughs);~negative pressure pulmonary edema;~stridor."|24 hours||||Participants|||Count of Participants
2600462|NCT02161757|Secondary|Number of Patients Positive for Anti-drug Antibodies (ADAs)|ADA assessments performed using a tiered approach (screening, confirmatory and titering assays). Confirmed ADA positive samples were also tested for neutralising antibodies (nAb). ADA prevalence defined as proportion of study population with drug-reactive antibodies at any point in time. ADA incidence (treatment-emergent ADA) defined as sum of treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Persistently positive defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive defined as having ≥1 post-baseline ADA positive assessment and not fulfilling conditions of persistently positive. Treatment-boosted ADA defined as baseline positive ADA titer boosted to a 4-fold or higher level following drug administration. In some category titles 'positive' is denoted by 'pos'.|Baseline (Week 0), Week 26, Week 56 (follow-up) and Week 72 (follow-up)|The ADA evaluable population included all patients in the safety analysis set (i.e. those who had received any IP) who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result.|||Participants|||Count of Participants
2600492|NCT02161575|Secondary|Change in Maximum PED Diameter From Baseline to Day 180|Change from Baseline to Day 180 in Maximum Pigment Epithelial Detachment (PED) Diameter. Data collected on the study eye were used for the evaluation of efficacy.|Baseline and Day 180|FAS|||micrometer||Full Range|Median
2600463|NCT02161757|Secondary|Serum Trough Concentration (Ctrough) of Tralokinumab During the Study Period up to Week 72|To evaluate the pharmacokinetics (PK), pre-dose blood samples were collected at each visit and tralokinumab concentrations in serum were determined. Mean Ctrough concentrations are presented at each indicated visit up to Week 72.|Blood samples were collected pre-dose at Baseline (Week 0), and at Week 4, Week 8, Week 26, Week 52 and Week 72 (follow-up)|All patients in the FAS who received tralokinumab and who had PK blood samples were included in the PK analysis set. Only patients with data available at the timepoints of testing were included in the analysis.|||micrograms/millilitre||Geometric Coefficient of Variation|Geometric Mean
2600464|NCT02161757|Secondary|Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry|"Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of assessments was calculated across all patients for the following healthcare encounter category:~• Spirometry."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.|||Assessments|||Number
2600465|NCT02161757|Secondary|Asthma-related Healthcare Encounters by Type up to Week 52: Hospitalisations|"Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of days spent in hospital was calculated across all patients for the following healthcare encounter category:~• Hospitalisations (hospitalisations, intensive care and/or general care)."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.|||Days|||Number
2600466|NCT02161757|Secondary|Asthma-related Healthcare Encounters by Type up to Week 52|"Broad-based healthcare utilisation asthma-related event information was collected by the Investigator/authorised delegate at each visit. At Visit 1, healthcare resource utilisation information was collected with a 1-year recall period; subsequent visits collected information with a recall period of 'since the last scheduled visit'. Total number of times the healthcare encounter occurred was calculated across all patients for each of the following categories:~Ambulance transport,~Emergency room visits,~Unscheduled outpatient visits (visit to specialist and/or visit to primary healthcare physician and/or other healthcare visit),~Home visits (home visit, physician and/or other healthcare professional),~Telephone calls (telephone calls to physician and/or nurse), and~Advanced pulmonary function test."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.|||Encounters|||Number
2600467|NCT02161757|Secondary|WPAI+CIQ: Activity Impairment at Week 52|"The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days.~The WPAI+CIQ outcomes for activity impairment are presented separately for those currently employed and for those currently in school and are expressed as mean impairment percentages at Week 52, with higher numbers indicating greater impairment.~Activity impairment = (Q10/10)*100. Note: QX refers to response to question number X on WPAI+CIQ questionnaire."|At Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoint of testing were included in the analysis.|||Percent Impairment||Standard Deviation|Mean
2600468|NCT02161757|Secondary|Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52|"The WPAI+CIQ consists of questions about how asthma and asthma-related issues impact a patient's ability to work, attend classes and perform regular daily activities. The questionnaire contains 10 questions relating to the patient's experience over the previous 7 days. The WPAI+CIQ outcomes for productivity loss are presented separately for those currently employed and for those currently in school and are expressed as mean productivity loss (percentage) at Week 52, with higher numbers indicating less productivity.~Work Productivity Loss = {Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]}*100 (Absenteeism = Q2/(Q2+Q4)*100; Presenteeism = (Q5/10)*100).~Class Productivity Loss = {Q7/(Q7+Q8) + [(1-Q7/(Q7+Q8))x(Q9/10)]}*100 (Absenteeism = Q7/ (Q7+Q8)*100; Presenteeism = (Q9/10)*100).~Note: QX refers to response to question number X on WPAI+CIQ questionnaire."|At Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoint of testing were included in the analysis.|||Percent productivity loss||Standard Deviation|Mean
2600469|NCT02161757|Secondary|Number of Patients With ≥1 Asthma Exacerbation up to Week 52|The number of patients with ≥1 asthma exacerbation up to Week 52 is presented.|Baseline (Week 0) up to Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.|||Participants|||Count of Participants
2600470|NCT02161757|Secondary|Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage])|The patient captured night-time awakenings (yes/no) and the use of rescue medication during these awakenings (yes/no) each morning in the Asthma Daily Diary. Night-time awakenings (percentage) was defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data. The change from baseline in bi-weekly means (percentage) night-time awakenings due to asthma requiring rescue medication use at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.|||Percentage of nights with awakenings||Standard Deviation|Mean
2600493|NCT02161575|Secondary|Change in Maximum PED Height From Baseline to Day 180|Change from Baseline to Day 180 in Maximum Pigment Epithelial Detachment (PED) Height. Data collected on the study eye were used for the evaluation of efficacy.|Baseline and Day 180|FAS|||micrometer||Full Range|Median
2618710|NCT01969214|Secondary|Stool Frequency|The mean number of daily defecation.|96 hours||||No. of daily defecation||Standard Deviation|Mean
2600471|NCT02161757|Secondary|Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52|Home PEF testing was performed by the patient using an electronic, hand-held spirometer (peak flow meter) and was performed in the morning upon awakening (prior to taking their morning asthma controller) and in the evening at bedtime (prior to taking their evening asthma controller). The mean change from baseline in home PEF values at Week 52 are presented separately for morning and evening.|Baseline (Week 0) and Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.|||L/min||Standard Deviation|Mean
2600472|NCT02161757|Secondary|Change From Baseline in Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means)|Salbutamol, albuterol or levalbuterol were used as rescue medication during the study in the event of a worsening of asthma symptoms. Rescue medication use was measured by the bi-weekly mean number of inhalations (puffs) per day, calculated as: total morning puffs + total evening puffs + 2*(total morning nebuliser use + total evening nebuliser use)/ total number of days with data in bi-weekly period. The change from baseline in bi-weekly mean total asthma rescue medication use at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.|||Puffs/day||Standard Deviation|Mean
2600473|NCT02161757|Secondary|Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at Week 52|The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The patient was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The questionnaire also included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state. The mean change from baseline in EQ-5D-5L VAS scores at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2600474|NCT02161757|Secondary|AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52|"The annual rate of exacerbations associated with an ER/UC visit or hospitalisation up to Week 52 are presented for non-adjudicated data (i.e. events assessed by the Investigator and recorded in the electronic case report form).~AAER = Number of Exacerbations*365.25 / (Follow-up date - Date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks)."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.|||Events/year||95% Confidence Interval|Number
2600475|NCT02161757|Secondary|Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score|The ACQ-6 questionnaire is a shortened version of the ACQ (omitting FEV1 measurement) that assesses asthma symptoms (night-time awakenings, symptoms on waking, activity limitation, dyspnoea, wheezing) and rescue short-acting β2-agonists medication use during the past week. Questions were weighted equally and scored on a 7-point scale from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses, ranging from 0 (totally controlled) to 6 (severely uncontrolled). Mean scores of ≤0.75 indicate well-controlled asthma, scores between 0.75 and ≤1.5 indicate partly controlled asthma and a score >1.5 indicates not well-controlled asthma. Individual changes of at least 0.5 were considered to be clinically meaningful. The mean change from baseline in ACQ-6 score at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2600476|NCT02161757|Secondary|Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score|The AQLQ(S)+12 is a questionnaire that measures health-related quality of life for patients with asthma aged 12 and older. The questionnaire comprises 32 questions and has 4 separate domains (asthma symptoms, activity limitations, emotional function and environmental stimuli). Patients were asked to recall their experiences during the previous 2 weeks and to score each of the questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The total score was calculated as the mean response to all questions, ranging from 1 (severe impairment) to 7 (no impairment). Individual AQLQ(S)+12 total score changes of ≥0.5 were considered to be clinically meaningful. The mean change from baseline in AQLQ(S)+12 score at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2600477|NCT02161757|Secondary|Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means)|Asthma symptoms during night-time and daytime were recorded by the patient each morning and evening in the Asthma Daily Diary. Symptoms were recorded using a 4-point response scale, which ranged from 0 to 3, where 0 indicated no asthma symptoms. Asthma symptom daytime score (recorded in the evening), night-time score (recorded in the morning), and total score were calculated separately. The daily asthma symptom total score was calculated by taking the sum of the night-time and daytime asthma symptom scores recorded each day, ranging from 0 to 6. A lower symptom score indicated a better outcome. The change from baseline in bi-weekly mean daily asthma symptom total score is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.|||Scores on a scale||Standard Deviation|Mean
2600494|NCT02161575|Secondary|Number of Patients With Dry Retina Assessed at Baseline and Day 180|Presence or absence of qualitative OCT parameter Dry Retina. Data collected on the study eye were used for the evaluation of efficacy.|Baseline and Day 180|FAS|||Participants|||Count of Participants
2618711|NCT01969214|Secondary|Number of Watery Stools||96 hours||||stools|||Number
2600478|NCT02161757|Secondary|Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)|Lung function was assessed by FEV1 which was measured by spirometry. Spirometry was performed by the Investigator or authorised delegate according to American Thoracic Society/European Respiratory Society guidelines. The mean percent change from baseline in pre-BD FEV1 at Week 52 is presented.|Baseline (Week 0) and Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study. Only patients with data available at the timepoints of testing were included in the analysis.|||Percent change from baseline||Standard Deviation|Mean
2600479|NCT02161757|Primary|Annualised Asthma Exacerbation Rate (AAER) up to Week 52|"Asthma exacerbation was defined as a worsening of asthma that led to any of the following:~Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids.~An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for <24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids (see above).~An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma.~AAER = number of exacerbations*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks).~AAER in the tralokinumab group was compared to that seen in the placebo group up to Week 52 using a negative binomial model; rate ratios and rate reductions are both presented for comparative statistical analyses."|Baseline (Week 0) up to Week 52|The FAS included all randomised patients who received at least one dose of IP, irrespective of their protocol adherence and continued participation in the study.|||Events/year||95% Confidence Interval|Number
2600480|NCT02161731|Secondary|PD: Maximum Observed International Normalized Ratio Response (INRmax) of Warfarin||Days 1 and 17: 0, 6, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose|All participants who received a dose of study drug and had evaluable date for INRmax.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2600481|NCT02161731|Secondary|Pharmacodynamics (PD): Area Under the International Normalized Ratio Curve (AUC[INR]) of Warfarin|The INR is a standardized ratio of the prothrombin time (PT), time it takes for blood to clot. AUC[INR] is the time curve used to measure change in INR over time.|Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose|All participants who received a dose of study drug and had evaluable data for AUC[INR].|||ratio times hour (ratio*h)||Geometric Coefficient of Variation|Geometric Mean
2600482|NCT02161731|Secondary|PK: Cmax of R-warfarin||Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose|All participants who received a dose of study drug and had evaluable data for Cmax of R- enantiomers of Warfarin.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2600483|NCT02161731|Secondary|PK: AUC[0-∞] of R-warfarin||Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose|All participants who received a dose of study drug and had evaluable data for AUC[0-∞].|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2600484|NCT02161731|Primary|PK: Maximum Observed Concentration (Cmax) of S-warfarin||Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose|All participants who received a dose of study drug and had evaluable data for Cmax.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2600485|NCT02161731|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of S-Warfarin||Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose|All participants who received a dose of study drug and had evaluable data for AUC [0-∞].|||nanogram*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2600486|NCT02161705|Secondary|Quality of Life Scores as Assessed by the BREAST-Q Score|"To determine if long-term changes in Quality of Life scores [BREAST-Q scores] differ between women undergoing mastectomy followed by immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks.~The BREAST-Q score questionnaire items in each scale are arranged in a clinically relevant hierarchy (e.g., Satisfaction with Breasts scale ranges from How satisfied are you with how you look in a mirror clothed? to How satisfied are you with how you look in the mirror unclothed?). Scores will range from 0-100. Lower scores indicate lower quality of life and vice versa.~This data will be collected via validated questionnaires through patient interviews at 1-month, 3-months, 2-years, and 4-years (±14 days) after surgery.~Once enrolled in the study, participants will be encouraged to remain in the study for the 4 years following surgery in order to get final pain scores and quality-of-life/heal"|Postoperative Day-30, Day-90 , 2-years, and 4-years (±14 days) after surgery.|The minimum data needed to assess this outcome measure was not collected for any participant and thus could not be analyzed for any of the participants.||||||
2600487|NCT02161705|Primary|Postoperative Static Pain Score|"To determine if post-operative static pain scores differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander breast reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks.~Post-operative pain, pain medication/narcotic use, and assessment for adverse events (AEs)/serious adverse events (SAEs) will be assessed the Day of surgery through post-operative Day 7. A clinic visit occurs on Day 7 where additional data collected (updated medical history, pain medication/narcotic use, AEs/SAEs, and study questionnaires).~Static pain refers to pain when the patient is at rest. Patients report pain on a scale of 0-10 were in 0 represents no pain and 10 the most severe pain they have experienced."|Day of Surgery through Day 7|1 Patient in the saline group was lost to follow-up|||units on a scale||Inter-Quartile Range|Median
2600488|NCT02161575|Secondary|Incidence of Ocular TEAEs in the Study Eye Reported by ≥2% Patients From Baseline to Day 180|Incidence of ocular Treatment Emergent Adverse Events (TEAEs) in the study eye reported by ≥2% patients by preferred term.|Baseline to Day 180|SAF|||Participants|||Count of Participants
2600489|NCT02161575|Secondary|Change in ETDRS Letters for Study Eye From Baseline to Day 180|Number of patients gaining at least 15 letters from Baseline to Day 180|Baseline and Day 180|FAS|||Participants|||Count of Participants
2600495|NCT02161575|Secondary|Number of Patients With Pigment Epithelial Detachments Assessed at Baseline and Day 180|Presence or absence of qualitative OCT parameter Pigment Epithelial Detachments. Data collected on the study eye were used for the evaluation of efficacy.|Baseline and Day 180|FAS|||Participants|||Count of Participants
2600496|NCT02161575|Secondary|Number of Patients With Intraretinal/Subretinal Fluid Within the Central Subfield Fluid Assessed at Baseline and Day 180|Presence or absence of qualitative OCT parameter Intraretinal/Subretinal Fluid Within the Central Subfield. Data collected on the study eye were used for the evaluation of efficacy.|Baseline and Day 180|FAS|||Participants|||Count of Participants
2600497|NCT02161575|Secondary|Number of Patients With Subretinal Fluid Assessed at Baseline and Day 180|Presence or absence of qualitative OCT parameter Subretinal Fluid. Data collected on the study eye were used for the evaluation of efficacy.|Baseline to Day 180|FAS|||Participants|||Count of Participants
2600498|NCT02161575|Secondary|Number of Patients With Intraretinal Fluid Assessed at Baseline and Day 180|Presence or absence of qualitative OCT parameter Intraretinal Fluid. Data collected on the study eye were used for the evaluation of efficacy.|Baseline and Day 180|FAS|||Participants|||Count of Participants
2600499|NCT02161575|Secondary|Change in Central Subfield Retinal Volume (CSRV) From Baseline to Day 180|Measurement of change in CSRV from Baseline to Day 180 as determined by high definition optical coherence tomography (HD-OCT). A reduction indicates an improvement in overall disease activity. Data collected on the study eye were used for the evaluation of efficacy.|Baseline and Day 180|FAS|||cubic micrometer||Full Range|Median
2600500|NCT02161575|Secondary|Change in Central Subfield Retinal Thickness (CSRT) From Baseline to Day 180|Measurement of change in CSRT from Baseline to Day 180 as determined by high definition optical coherence tomography (HD-OCT). A reduction indicates an improvement in overall disease activity. Data collected on the study eye were used for the evaluation of efficacy.|Baseline and Day 180|FAS|||micrometer||Full Range|Median
2600501|NCT02161575|Secondary|Change in Subfoveal Retinal Thickness (SRT) From Baseline to Day 180|Measurement of change in SRT from Baseline to Day 180 as determined by high definition optical coherence tomography (HD-OCT). A reduction indicates an improvement in overall disease activity. Data collected on the study eye were used for the evaluation of efficacy.|Baseline and Day 180|FAS|||micrometer||Full Range|Median
2600502|NCT02161575|Primary|Change in Central Subfield Retinal Thickness (CSRT) From Baseline to Day 90.|Measurement of the change in CSRT, determined by high definition optical coherence tomography (HD-OCT) after 3 monthly injections of ranibizumab. OCT is a non-invasive technique which can determine and measure thickness of the retina. A negative change from Baseline indicates an improvement (less retinal fluid and lower disease activity). Data collected on the study eye were used for the evaluation of efficacy.|Baseline and Day 90|FAS - Missing values at Day 90 were imputed using Last Observation Carried Forward (LOCF) where possible. For the change from baseline, only patients with a value at both baseline and Day 90 were included.|||micrometer||Full Range|Median
2600503|NCT02161562|Secondary|The Number of Participants Who Remained Well-controlled (UAS7<=6) or Who Had Achieved UAS=0 at Phase 4 (Second Dosing Period) Week 8 During Retreatment After Being Well Controlled or Achieving UAS7=0 at Phase 2 (Initial Dosing Period) Week 8|The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from week 8 of initial dosing phase and week 8 of second dosing phase.|Week 8 of initial dosing phase and week 8 of second dosing phase|Only Groups A2 and B2 participants, who had UAS7 scores collected at week 8 of initial dosing period and week 8 of second dosing period, were analyzed.|||Participants|||Number
2600504|NCT02161562|Secondary|Change in Urticaria Activity Score Over 7 Days (UAS7) Between Baseline and End of Second Dosing Period|The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the 7 days before Baseline and the last 7 days of the second dosing period.|7 days prior to Baseline visit, and last 7 days of second dosing period|Group A (n=178) and Group B (n=136) participants were considered for the analysis. Only Group A and Group B participants who had both baseline and week 44 UAS7 scores collected, were analyzed.|||score on a scale||Standard Deviation|Mean
2600505|NCT02161562|Secondary|The Change in Urticaria Activity Score Over 7 Days (UAS7) From Baseline to Week 24 in Group B Participants|The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the 7-day period prior to Baseline visit and the last 7 days prior to the week 24 visit of initial dosing period. A negative change from baseline indicates improvement.|7 days prior to Baseline visit, and last 7 days prior to week 24 of the initial dosing period|Group B participants (n=136) were considered for the analysis. Only Group B participants, who had both baseline and week 24 UAS7 scores collected, were analyzed.|||score on a scale||Standard Deviation|Mean
2600506|NCT02161562|Secondary|Difference in Urticaria Activity Score Over 7 Days (UAS7) Between End of Initial Dosing Period and the End of the Second Dosing Period, in Group B3 Participants Who Did Not Respond to the Initial Dosing Period|The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the last 7 days of the initial dosing period and the last 7 days of the second dosing period. A negative change indicates improvement.|last 7 days of initial dosing period, week 24, and last 7 days of second dosing period, week 36|Group B3 participants (n=43) were considered for the analysis. Only B3 participants, who had UAS7 scores collected at both weeks 24 and 44, were included in the analysis.|||score on a scale||Standard Deviation|Mean
2600507|NCT02161562|Secondary|Time to Relapse (Urticaria Activity Score Over 7 Days (UAS7) ≥ 16) After Drug Withdrawal in Participants Who Responded to Initial Dosing Period (Retreatment A2 and B2)|The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the time between end of initial dosing period to first occurence of UAS7 ≥ 16 will be evaluated.|study drug withdrawal period, weeks 24 through 32|The Retreatment participants were analyzed (A2=12, B2=44).|||Weeks||Standard Deviation|Mean
2600624|NCT02159950|Other Pre-specified|Effects of Tasquinimod on the Inhibition of Immune Cells||Up to week 50|Due a Lack of funding data was not collected and no patients were analyzed.||||||
2618712|NCT01969214|Secondary|Number of Daily Defecation||96 hours||||stools|||Number
2600508|NCT02161562|Secondary|Number of Participants With Urticaria Activity Score Over 7 Days (UAS7)≤6 at the End of the Second Dosing Period, in Participants Who Stepped-up Treatment Dosing (Step-up A3)|The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the last 7 days of the second dosing period.|Last 7 days of the second dosing period|Group A3 participants (n=141) were considered for the analysis. Only Group A3 participants, who had UAS7 scores collected at the end of the second dosing period, were analyzed.|||Participants|||Number
2600509|NCT02161562|Secondary|The Difference in Urticaria Activity Score Over 7 Days (UAS7) Between the Start and End of the Second Dosing Period, in Participants That Step-up Treatment Dose During the Initial Dosing Period (Step-up A3)|The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the 7 days prior to the second dosing period, and the last 7 days of the second dosing period. A negative change indicates improvement.|7 days prior to start of second dosing period and last 7 days of Second Dosing Period|Group A3 participants (n=141) were considered for the analysis. Only Group A3 participants, who had UAS7 scores collected at the start and end of the second dosing period, were analyzed.|||score on a scale||Standard Deviation|Mean
2600510|NCT02161562|Primary|Number of Participants Who Were Clinically Well-controlled (UAS7<=6) After the Initial Dosing Period, Relapsed (UAS7>=16) When Treatment Was Discontinued, and Who Achieved a UAS7 Score <=6 at the End of the Second Dosing Period (Retreatment A2 and B2)|The UAS7 is a 7-day composite self-reported evaluation of itch (daily score 0-3) plus number of hives (daily score 0-3). The worst possible daily UAS score is 6, and the worst possible UAS7 score is 42. For this outcome, the participant's self-reported UAS7 score will be drawn from the last 7 days of the second dosing period.|Last 7 days of second dosing period, 44 weeks|Participants from groups A2 (n=12) and B2 (n=44) were considered for the analysis. Only Groups A2 and B2 participants, who had UAS7 scores collected at end of the second dosing period, were analyzed.|||Participants|||Count of Participants
2600511|NCT02161549|Primary|Mean Score of Boston Bowel Preparation Scale (BBPS) Index Prior and After the Use of MotusGI CleanUp System|Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon). average of all colon segments BBPS score after the use of MotusGI CleanUp System|during colonoscopy procedure after cleansing with CleanUp System|the mean and standard deviation of the average score after cleansing the colon using the Motus CleanUp System|||units on a scale||Standard Deviation|Mean
2600512|NCT02161536|Primary|The Count and Percentage of Subjects Had Adequate Bowel Preparation After the Use of Motus Cleansing Stystem|"The number of subjects had adequate bowel preparation after the use of Motus Cleansing System (i.e., all colon segments have BBPS>=2) .~Each colon segment was graded by using the Boston Bowel Preparation Score index before ( at baseline) and after the cleansing of the bowel by using the Motus Cleansing System."|Following the colonoscopic procedure- Up to 24 hours.|subjects had adequate bowel preparation after the use of Motus Cleansing System (i.e., all colon segments have BBPS>=2)|||Participants|||Count of Participants
2600513|NCT02161484|Other Pre-specified|Incidence of Complications (e.g. Frequency of Foot-drop).|"Complications such as drug toxicity, arrhythmia, bradycardia, hematoma, Foot Drop, allergic reaction will be recorded"|48 hours after the start of the surgery||||Number of complications|||Number
2600514|NCT02161484|Secondary|Total Amount of Local Anesthetic in 48 Hours Post Operatively|Combined amount of Bupivacaine Boluses + Continuous infusion in (cc)|48 hours after the start of the surgery|Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.||||||
2600515|NCT02161484|Secondary|Number of Nerve Block Boluses (Bupivacaine) Administered by the Nurse Post Operatively||48 hours after the start of the surgery|Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.||||||
2600516|NCT02161484|Secondary|Total Dilaudid or Opiate Equivalent Consumed (mg) Over 48 Hours Post Operatively||48 hours after the start of the surgery|Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.||||||
2600517|NCT02161484|Secondary|Amount of Oxycodone for the First 48 h Post Operatively|Including number of dose and mg).|48 hours after the start of the surgery|Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.||||||
2600518|NCT02161484|Secondary|Number of Rescue Boluses Administered by Nurse (IV Dilaudid) Post Operatively||48 hours after the start of the surgery|Results were not collected per source documentation. Since the IRB has expired, data pertaining to medications cannot be extracted from the medical record retrospectively.||||||
2600519|NCT02161484|Primary|Numeric Rating Scale (NRS) Pain Assessment|Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.|48 hours after the start of surgery||||units on a scale||Standard Deviation|Mean
2600520|NCT02161484|Primary|Numeric Rating Scale (NRS) Pain Assessment|Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.|24 hours after the start of surgery||||units on a scale||Standard Deviation|Mean
2600521|NCT02161484|Primary|Numeric Rating Scale (NRS) Pain Assessment|Postoperative pain assessments using a 11-point numerical rating during physical therapy and at rest. This pain scale ranges from 0, being no pain at all, up to 10 being the worst pain ever experience.|6 hours after the start of surgery||||units on a scale||Standard Deviation|Mean
2600522|NCT02161458|Primary|Amyloid Beta Levels in CSF|Change in the level of Amyloid Beta peptides (Amyloid Beta 42 and Amyloid Beta 40) in the CSF between the measurement at baseline and the measurement after exposure with escitalopram.|2 - 8 Weeks (we used week 8 minus baseline and week 2 minus baseline)||||pg/mL||Standard Deviation|Mean
2600625|NCT02159950|Secondary|Time to PSA Progression||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.||||||
2600523|NCT02161406|Secondary|Change From Baseline to Month 12 in HAQ-DI - Common Daily Activities|The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600524|NCT02161406|Secondary|Change From Baseline to Month 12 in HAQ-DI - Walking|The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600525|NCT02161406|Secondary|Change From Baseline to Month 12 in HAQ-DI - Grip|The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600526|NCT02161406|Secondary|Change From Baseline to Month 12 in HAQ-DI - Eating|The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600527|NCT02161406|Secondary|Change From Baseline to Month 12 in HAQ-DI - Reach|The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600528|NCT02161406|Secondary|Change From Baseline to Month 12 in HAQ-DI - Arising|The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600529|NCT02161406|Secondary|Change From Baseline to Month 12 in HAQ-DI - Hygiene|The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600530|NCT02161406|Secondary|Change From Baseline to Month 12 in HAQ-DI - Dressing and Grooming|The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600531|NCT02161406|Secondary|Change From Baseline to Month 12 in PROMIS - Sleep Impairment|The Patient-Reported Outcomes Measurement Information System (PROMIS) 8-question short-form health-reported quality of life measure sleep impairment domain was administered. The transformed score (T-score) was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).|Baseline and Week 52|Modified Intent-to-Treat population includes all of the randomized participants who received at least one dose of study medication|||score on a scale||Standard Error|Least Squares Mean
2600532|NCT02161406|Secondary|Change From Baseline to Month 12 in PROMIS - Sleep Disturbance|The Patient-Reported Outcomes Measurement Information System (PROMIS) 4-question short-form health-reported quality of life measure sleep disturbance domain was administered. The transformed score (T-score) was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).|Baseline and Week 52|Modified Intent-to-Treat population includes all of the randomized participants who received at least one dose of study medication|||score on a scale||Standard Error|Least Squares Mean
2600533|NCT02161406|Secondary|Change From Baseline to Month 12 in PROMIS - Fatigue|The Patient-Reported Outcomes Measurement Information System (PROMIS) 8-question short-form health-reported quality of life measure fatigue domain was administered. The transformed score (T-score) was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600534|NCT02161406|Secondary|ACR CRISS at 12 Months|The American College of Rheumatology Combined Response Index in Systemic Sclerosis is a composite endpoint. It is determined in a 2-step process. The first step assesses whether the patient has had a significant decline in renal or cardiopulmonary involvement. If none of these apply, the second step assesses the probability of improvement by measuring changes in five outcomes and integrating them into a single number using an equation described in Khanna D, Berrocal VJ, et al. [The American College of Rheumatology Provisional Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic Sclerosis. Arthritis and Rheumatology. 2016; 68(2):299-311.]. It incorporates changes in the modified Rodnan skin score, percent predicted forced vital capacity (FVC), patient and physician global assessments, and SHAQ-DI over 1 year. The score ranges from 0 to 1; a higher score indicates better outcome.|Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||units on a scale||Inter-Quartile Range|Median
2600626|NCT02159950|Secondary|Progression-free Survival||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.||||||
2600627|NCT02159950|Secondary|Overall Survival||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.||||||
2600535|NCT02161406|Secondary|Change From Baseline to Month 12 in SCTC GIT - Composite Score|The SCTC GIT is the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Instrument. It assesses scleroderma-related gastrointestinal symptoms. The composite score ranges from 0 to 2.83; 0 indicates better health and higher score indicates worse health.|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600536|NCT02161406|Secondary|Change From Baseline to Month 12 in PROMIS-29 - Pain Intensity|The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the pain intensity domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600537|NCT02161406|Secondary|Change From Baseline to Month 12 in PROMIS-29 - Ability to Participate in Social Roles & Activities|The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the ability to participate in social roles and activities domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600538|NCT02161406|Secondary|Change From Baseline to Month 12 in PROMIS-29 - Pain Interference|The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the pain interference domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600539|NCT02161406|Secondary|Change From Baseline to Month 12 in PROMIS-29 - Sleep Disturbance|The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the sleep disturbance domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e.,worse outcome).|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600540|NCT02161406|Secondary|Change From Baseline to Month 12 in PROMIS 29 - Fatigue|The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the fatigue domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600541|NCT02161406|Secondary|Change From Baseline to Month 12 in PROMIS-29 - Depression|The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the depression domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600542|NCT02161406|Secondary|Change From Baseline to Month 12 in PROMIS-29 - Anxiety|The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the anxiety domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600543|NCT02161406|Secondary|Change From Baseline to Month 12 in PROMIS-29 - Physical Function|The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the physical function domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600544|NCT02161406|Secondary|Change From Baseline to Month 12 in Tender Joint Counts|28 joints are assessed for tenderness (positive or negative). The number of tender joint counts ranges from 0 to 28. A higher number indicates worse outcome.|Baseline and 52 weeks|mITT population includes all of the randomized participants who received at least one dose of study medication.|||number of tender joints||Standard Error|Least Squares Mean
2600545|NCT02161406|Secondary|Change From Baseline to Month 12 in Swollen Joint Count|28 joints are assessed for swelling (positive or negative). The number of swollen joint count ranges from 0 to 28. A higher number indicates worse outcome.|Baseline and 52 weeks|mITT population includes all of the randomized participants who received at least one dose of study medication.|||number of swollen joints||Standard Error|Least Squares Mean
2600546|NCT02161406|Secondary|Change From Baseline to Month 12 in SHAQ-DI VAS - GI Involvement|Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much intestinal problems interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600547|NCT02161406|Secondary|Change From Baseline to Month 12 in SHAQ-DI VAS - Burden of Digital Ulcers|Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much finger ulcers interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600548|NCT02161406|Secondary|Change From Baseline to Month 12 in SHAQ-DI VAS - Raynaud's|Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much Raynaud's interfered with daily activities ranges from 0 (does not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600549|NCT02161406|Secondary|Change From Baseline to Month 12 in SHAQ-DI VAS - Breathing|Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much breathing problems interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600550|NCT02161406|Secondary|Change From Baseline to Month 12 in SHAQ-DI VAS - Overall Disease|Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud's, gastrointestinal involvement, breathing, and overall disease. The VAS scale for disease severity ranges from 0 (no disease) to 150 (very severe). A higher score means a worse outcome.|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600551|NCT02161406|Secondary|Change From Baseline to Month 12 in HAQ-DI - Overall|The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI overall score ranges from 0 (no disability) to 3 (severe disability). Higher score means worse outcome.|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600552|NCT02161406|Secondary|Change From Baseline to Month 12 in FVC (in ml)|FVC = forced vital capacity, a measure of lung function|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||ml||Standard Error|Least Squares Mean
2600553|NCT02161406|Secondary|Change in % Predicted FVC|FVC is Forced vital capacity, a measure of lung function. FVC % Predicted is calculated using equations from Hankinson [Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999;159(1):179-87], incorporating age, gender, and race. It is calculated as the (FVC Observed / FVC predicted) * 100, where FVC predicted is calculated relative to a reference population.|Baseline and 52 weeks|mITT population includes all of the randomized participants who received at least one dose of study medication.|||percent predicted||Standard Error|Least Squares Mean
2600554|NCT02161406|Secondary|Change From Baseline to Month 12 in Physician Global Assessment for Overall Disease|This assessment represents the physician's assessment of the patient's current disease activity on a 0 (excellent) -10 (extremely poor) Likert scale. Higher score means worse outcome.|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600555|NCT02161406|Secondary|Change From Baseline to Month 12 in Patient Global Assessment for Overall Disease|Patient global assessment for overall disease represents the patient's assessment of the patient's global scleroderma on a 0 (excellent) -10 (extremely poor) Likert scale. Higher score means worse outcome.|Baseline and Week 52|mITT population includes all of the randomized participants who received at least one dose of study medication.|||score on a scale||Standard Error|Least Squares Mean
2600556|NCT02161406|Primary|Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Month 12|The efficacy of treatment on skin fibrosis will be measured by changes from baseline to month 12 in mRSS, a measure of skin thickness. mRSS scores have a range from 0 to 51, with higher score indicating greater severity of SSc (worse outcome).|Baseline and 52 weeks|mITT population includes all of the randomized participants who received at least one dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
2600557|NCT02161406|Primary|Proportion of Participants With at Least One Adverse Events (AEs) or Serious AEs (SAEs) in 1 Year|Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of abatacept, and using serious AEs|52 weeks|mITT population includes all of the randomized participants who received at least one dose of study medication.|||Participants|||Count of Participants
2600558|NCT02161185|Secondary|Treatment Success|Termination of seizure(s) within 10 minutes and no recurrence within 6 hours after study drug administration. Due to early termination of the study, this data was not analyzed.|Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.|Not applicable. Only 6 subjects treated at least 1 seizure cluster; of the treated seizure clusters, the majority were in only 2 subjects. Analysis of this endpoint was not performed as the sponsor believed the results would not be interpretable.||||||
2600559|NCT02161185|Primary|Number of Participants With Death, Serious Adverse Events, Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation|Number of Participants with Death, Serious Adverse Events, Treatment emergent adverse events (TEAEs) leading to subject discontinuation from study|Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.|Participants who received at least one dose of study drug|||Participants|||Count of Participants
2600628|NCT02159950|Secondary|Objective Response Rates (Partial or Complete)||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.||||||
2600629|NCT02159950|Secondary|Immune Response (Arm 2 Only)||Week 0|Due a Lack of funding data was not collected and no patients were analyzed.||||||
2600560|NCT02161146|Secondary|Conjunctival Hyperemia Score|Hyperemia is the engorgement of the blood vessels (redness) of the eye. Ocular hyperemia was evaluated by the investigator 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 15 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no hyperemia) to 4.0=extremely severe (large, numerous dilated blood vessels characterized by severe deep red color). Data from Days 1 and 15 were pooled together and averaged.|Days 1 and 15|Participants from the Intent-to-Treat Population, all randomized participants, with data of treated eyes available for analysis.|||score on a scale|Eyes|Standard Deviation|Mean
2600561|NCT02161146|Primary|Ocular Itching Score|Ocular itching was assessed by the participant 8 hours after AGN-229666 and vehicle administration and 4 hours after olopatadine administration, 5 minutes post allergen challenge using a 0 to 4 scale with 0.5 grade increments where: 0=none (no itching) to 4.0=incapacitating itch with an irresistible urge to rub (worst). Data from Days 1 and 15 were pooled together and averaged.|Days 1 and 15|Participants from the Intent-to-Treat Population, all randomized participants, with data of treated eyes available for analysis.|||score on a scale|Eyes|Standard Deviation|Mean
2600562|NCT02161016|Other Pre-specified|Time to Full Weight-bearing|This will be the time from the date of surgery until the patient has full, unassisted weight bearing, and will be measured in weeks.|up to 24 months|||||||
2600563|NCT02161016|Secondary|CT Scan|A CT scan will be done at 6 months in order to assess bone fusion.|6 months|||||||
2600564|NCT02161016|Secondary|Foot Ankle Disability Index|The Foot Ankle Disability Index (FADI) is a self-report of function that assesses activities of daily living, with scores ranging from 0 to 100.|24 months|||||||
2600565|NCT02161016|Secondary|SF-36 Score|The SF-36 is a survey for health and well-being.|24 months|||||||
2600566|NCT02161016|Primary|AOFAS Foot-and-Ankle Score|The American Orthopaedic Foot and Ankle Society score returns an indexed score, from 0 - 100, to assess clinical outcomes following foot /ankle surgery.|24 months|||||||
2600567|NCT02160990|Secondary|Aggregate Satiation Symptom Score|"Postprandial fullness, nausea, bloating, and pain were measured 30 minutes after the liquid meal using 100 mm horizontal visual analog scales (VAS). The subscale scores could each range from none(0) to worst ever (100) at the left and right ends of the lines for each symptom. These satiation symptom scores (postprandial fullness, nausea, bloating, and pain) were combined to generate a total scale score with a different total scale range (0 - 400 mm) with 0 mm indicating none and 400 indicating worst ever."|Visit 3, approximately 30 min after ingestion of nutrient drink test||||mm||Inter-Quartile Range|Median
2600568|NCT02160990|Secondary|Buffet Meal Intake (kcal)|"Five hours after the standard egg meal ingested to measure gastric emptying, subjects were invited to eat, over a 30 minute period, a standard all you can eat meal. This meal consisted of either meat or vegetable lasagna, vanilla pudding, and skim milk. Personnel from the study team weighed the food servings post-meal and reported the amount of food left from single portions partially consumed. The total kcal of the food consumed was analyzed by using validated software."|"Visit 4, approximately 30 minutes after start of all you can eat meal"||||kcal||Inter-Quartile Range|Median
2600569|NCT02160990|Secondary|Maximum Tolerated Volume|In the last 5 days of medication administration, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a visual analog scale (VAS) from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure was the volume consumed when the fullness sensation reached level 5.|Visit 3, approximately 30 minutes after liquid meal||||mL||Inter-Quartile Range|Median
2600570|NCT02160990|Secondary|Satiation Expressed as Volume to Fullness|In the last 5 days of medication administration, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a visual analog scale (VAS) from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure was the volume consumed when the fullness sensation reached level 3.|Visit 3, approximately 30 minutes after liquid meal||||mL||Inter-Quartile Range|Median
2600571|NCT02160990|Secondary|Change in Body Weight||baseline, day 30||||kg||Inter-Quartile Range|Median
2600572|NCT02160990|Secondary|Percentage of Gastric Contents Emptied at 1 Hour|Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs contained a small amount of a radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 1 hour.|Visit 4, approximately 1 hours after radiolabeled meal was ingested||||percentage of meal emptied||Inter-Quartile Range|Median
2600573|NCT02160990|Primary|Gastric Emptying Half-time (T 1/2) of Solids|Gastric emptying of solids half-time is defined as the time for half of the ingested solids to leave the stomach. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs contained a small amount of a radioactive substance. Anterior and posterior gamma camera images were obtain immediately after radiolabeled meal ingestion, every 15 minutes for the first 2 hours, then 30 minutes for the next 2 hours (total 4 hours after the radiolabeled meal).|time frame is 30 days after the initiation of dose.||||minutes||Inter-Quartile Range|Median
2600574|NCT02160977|Secondary|VAS(Visual Analogue Scale/Score) of the Knee Joint|Scale Name:score scale range:0~100,and a higher values represent a worse outcome|6 months||||units on a scale||Standard Deviation|Mean
2600575|NCT02160977|Secondary|HSS(Hospital for Special Surgery) Score of the Knee Joint|Scale Name:score scale range:0~100,and a higher values represent a better outcome|6 months||||units on a scale||Standard Deviation|Mean
2600576|NCT02160977|Primary|Proprioception of the Knee Post Operation|"Proprioception of the knee position sense was assessed by the knee angle reproduction test (10~20 degree, 30~40 degree, 80~90 degree of the knee flexion) prior operation, and 1 week, 6 weeks, 3 months and 6 months post operation.~Scale Name:degree scale range:0~180 degree,and a higher values represent a worse outcome"|six months||||units on a scale||Standard Error|Mean
2600630|NCT02159950|Secondary|Immune Response||Week 50|Due a Lack of funding data was not collected and no patients were analyzed.||||||
2600631|NCT02159950|Secondary|Immune Response||Week 26|Due a Lack of funding data was not collected and no patients were analyzed.||||||
2600577|NCT02160899|Primary|Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)|An adverse event is any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product.|Up to approximately 32 weeks|The Safety Set included all randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2600578|NCT02160899|Primary|Percent Change From Baseline in Lipoprotein Lp(a) Plasma Concentration at Day 85/Day 99|Data are reported for evaluable participants.|Day 85/Day 99|The Per-Protocol Set included the subset of the Full Analysis Set who received at least 9 doses of Study Drug within the 12-week treatment period and who had no significant protocol deviations that would have been expected to affect efficacy assessments. Day 85/Day 99 result is defined as the result at Day 85 or Day 99.|||percent change||Standard Deviation|Mean
2600579|NCT02160873|Secondary|Urine Volume|Measurement of total urine output.|24 hour||||mililiters||Standard Deviation|Mean
2600580|NCT02160873|Other Pre-specified|Exercise Metabolism|Indirect calorimetry will be used to assess macronutrient use during exercise via the respiratory exchange ratio|24 hours||||Respiratory exchange ratio||Standard Deviation|Mean
2600581|NCT02160873|Secondary|Urine Specific Gravity|Changes in urine specific gravity will be measured pre and post a 10K time trial run on a treadmill|24 hours||||Urine specific gravity||Standard Deviation|Mean
2600582|NCT02160873|Primary|Running Performance|10K time trial on a treadmill|24 hours||||minutes||Standard Deviation|Mean
2600583|NCT02160847|Secondary|Change in Parent BMIz|The parent's body mass index z-scores (BMIz) was calculated by dividing the the parent's weight in kilograms (measured by a digital scale) by the parent's height in meters (measured by a stadiometer). These measurements were taken at each assessment point (pre-, mid-, and post-assessment).|Week 0, Week 9, Week 19||||BMIz||Standard Deviation|Mean
2600584|NCT02160847|Primary|Change in Child BMIz|The child's body mass index z-scores (BMIz) was calculated by dividing the the child's weight in kilograms (measured by a digital scale) by the child's height in meters (measured by a stadiometer). These measurements were taken at each assessment point (pre-, mid-, and post-assessment).|Week 0, Week 9, Week 19||||BMIz||Standard Deviation|Mean
2600585|NCT02160808|Secondary|Length of Hospitalization|Surrogate marker for operative success|Duration of study - average 30 days||||Days||Standard Deviation|Mean
2600586|NCT02160808|Secondary|Number of Participants With Intra-operative Intervention, Subsequent Biochemical Leak or B/C Fistula After Drug Administration|Following the administration of Secretin or Placebo intraoperatively, the surgeon will have the opportunity to evaluate the anastomosis to determine if there is ongoing leak. If there is ongoing leak, then the surgeon will be able to treat the leak intra-operatively prior to operative closure. In those patients in whom an intervention was performed, they were subsequently evaluated to determine if they developed a biochemical leak or grade B/C fistula.|Through completion of intra-operative intervention and subsequent biochemical leak, B/C Fistula up to 30 days post-operatively||||Participants|||Count of Participants
2600587|NCT02160808|Primary|Number of Participants With Biochemical Leak/Grade B Fistula/Grade C Fistula|Outcome based on revised ISGPS Guidelines which require a three day drain amylase concentration greater than 3x the normal serum amylase concentration. Biochemical leaks are the mildest for of fistula which have no clinical consequence. Grade B fistula are more severe requiring usually percutaneous drainage placement. Grade C fistula are most severe resulting in significant morbidity and/or death.|3 days||||Participants|||Count of Participants
2600588|NCT02160626|Secondary|Proportion of Subjects Who Had at Least 3 of 4 Target Lesions Judged to be Clear on the Physician Lesion Assessment (PLA =0) at Visit 8.|Proportion of Subjects who had at least 3 of 4 target lesions judged to be clear on the Physician Lesion Assessment (PLA =0) at visit 8. The PLA is a 4 point scale evaluating the severity of a lesion with 0 being clear and 3 being the most severe.|Baseline, visit 8|N = number of subjects who completed the study per protocol.|||Participants|||Count of Participants
2600589|NCT02160626|Secondary|Mean Change From Baseline to Visit 8 in the Physician's Lesion Assessment|"Change from baseline PLA will be calculated for each lesion first, then per-subject mean changes from baseline will be calculated.~The PLA is a score on a four scale from 0 to 3 with 0 being clear and 3 being the most severe, a lower score indicating a better result. For the mean change in this score, a larger mean change is a better result."|Baseline, visit 8|N = number of participants completing the protocol.|||units on a scale|Lesions|Standard Deviation|Mean
2600590|NCT02160626|Primary|Mean Per Subject Percentage Target Lesions Judged Clear by the Physician's Lesion Assessment (PLA)|Mean of per-subject percentages of target lesions judged to be clear on the PLA (PLA = 0) at end of study (Visit 8). The PLA is a four point scale from 0 being clear to 3 being most severe lesion.|Baseline, visit 8|Overall number of participants = number of participants completing the study per protocol.|||percentage of lesions cleared|Lesions|Standard Deviation|Mean
2600591|NCT02160535|Secondary|Change in HIT-6 Score.|Headache Impact Test-6 Minimum value: 36 Maximum value: 78 Lower values represent less disability.|Baseline and 9 month.||||score on a scale||Standard Deviation|Mean
2600592|NCT02160535|Secondary|Change in MIDAS Score|Migraine Disability Assessment Minimum score: 0 Maximum score: 270 Lower values show improvement in disability.|Baseline and 9 month.||||score on a scale||Standard Deviation|Mean
2600593|NCT02160535|Secondary|Change in SF-36 Assessment Scores|Short Form-36 (SF-36) assesses quality of life. Minimum score: 0 Maximum score: 100 Higher values show improvement in quality of life.|Baseline and 9 month.||||score on a scale||Standard Deviation|Mean
2600594|NCT02160535|Primary|Change in Mean Percentage of Headache Days|To measure average number of headache days three months after the last onaboltulinumtoxinA injection and compare to average number of headache days during screening month (and present as percentage of headache change).|Baseline, 9 months||||percentage of headache days||Standard Deviation|Mean
2600595|NCT02160314|Primary|Treatment-emergent Serious Adverse Event|proportion of intent-to-treat subjects who experience a treatment-emergent serious adverse event|3 month|Intent-to-treat (ITT)|||participants|||Number
2600632|NCT02159950|Secondary|Immune Response||Week 10|Due a Lack of funding data was not collected and no patients were analyzed.||||||
2600633|NCT02159950|Secondary|Immune Response||Week 6|Due a Lack of funding data was not collected and no patients were analyzed.||||||
2600596|NCT02160145|Other Pre-specified|Mean Change From Baseline in Urine Specific Gravity During the Double-blind Treatment Period and Post-treatment Follow-up|The mean change from baseline in urine specific gravity for the double-blind treatment period collection timepoints and post-treatment follow up are presented. Baseline was defined as the last evaluation prior to post-randomization dosing.|Baseline and Months 3, 6, 9 and 12 (End of treatment visit) of the double-blind treatment period, and post-treatment follow-up.|The primary safety population consisted of all subjects who were randomized and took at least 1 dose of IMP after randomization. Only subjects with data available for analysis at the timepoints of testing are presented.|||unitless||Standard Deviation|Mean
2600597|NCT02160145|Other Pre-specified|Mean Change From Baseline in Urine Osmolality During the Double-blind Treatment Period and Post-treatment Follow-up|The mean change from baseline in urine osmolality for the double-blind treatment period collection timepoints and post-treatment follow-up are presented. Baseline was defined as the last evaluation prior to post-randomization dosing.|Baseline and Months 3, 6, 9 and 12 (End of treatment visit) of the double-blind treatment period, and post-treatment follow-up.|The primary safety population consisted of all subjects who were randomized and took at least 1 dose of IMP after randomization. Only subjects with data available for analysis at the timepoints of testing are presented.|||milliosmole per kilogram (mOSm/kg)||Standard Deviation|Mean
2600598|NCT02160145|Secondary|Mean Annualized Slope of eGFR Change|"To compare the efficacy of tolvaptan treatment in reducing the decline of annualized eGFR slope, as compared with placebo, in subjects with late-stage CKD due to ADPKD who tolerated tolvaptan during an initial run-in period, the annualized rate of eGFR change was derived from each individual subject's eGFR slope using the CKD-EPI formula.~The annualized eGFR change slope was derived from all eGFR observations from placebo-run-in, tolvaptan run-in, double-blind treatment and post-treatment follow-up periods using the linear mixed model of analysis. The mean annualized slope of eGFR change is presented."|Pretreatment baseline to post-treatment follow-up (up to 61 weeks).|The key secondary endpoint efficacy population consisted of all randomized subjects who took at least 1 dose of IMP after randomization, and have a baseline (average of up to 3 eGFR values observed during screening and placebo run-in periods) and at least 1 post-randomization evaluation in eGFR during the double-blind treatment period.|||mL/min/1.73m^2/year||Standard Error|Least Squares Mean
2600599|NCT02160145|Primary|The Mean Annualized Change in eGFR From Pretreatment Baseline to Post-treatment Follow-up.|"The mean annualized change in eGFR was calculated using the Chronic Kidney Disease-Epidemiology (CKD-EPI) formula from pretreatment baseline to post-treatment follow-up, annualized (divided) by each subject's trial duration.~The baseline for the primary endpoint was defined as the average of up to 3 eGFR values observed during the screening and placebo run-in periods."|Pretreatment baseline to post-treatment follow-up (up to 61 weeks).|The primary endpoint efficacy population consisted of all subjects who were in the randomized sample, took at least 1 dose of investigational medicinal product (IMP) after randomization, and had a baseline and at least 1 valid post-treatment evaluation in eGFR (i.e at least 1 week off-treatment).|||mL/min/1.73 m^2/year||Standard Error|Least Squares Mean
2600600|NCT02160041|Secondary|Number of Participants With 99 Day Minimum Duration of Response (DOR)|The duration of response (PR or greater) applies only to patients whose best response was PR or greater. It is defined as the Ttime from the first documented response to the date first documented disease progression or relapse or death due to any cause|baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months|FAS|||Participants|||Count of Participants
2600601|NCT02160041|Secondary|Kaplan-Meier Estimates of Survival Rate, % (95% CI)|Overall survival (OS) is the time from the date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last contact.|months 3, 6, 9, 12, 24|FAS|||percent of participants||95% Confidence Interval|Number
2600602|NCT02160041|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause|every 8 weeks until death, assessed up to 36 months|FAS|||months||95% Confidence Interval|Median
2600603|NCT02160041|Secondary|Kaplan-Meier Estimates of PFS Rate, % (95% CI)||Months 1, 2, 3, 4, 5, 6, 12, 18, 24|FAS|||percent of participants||95% Confidence Interval|Number
2600604|NCT02160041|Secondary|Progression-Free Survival (PFS)|"Kaplan-Meier estimates of PFS timing, months~Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause"|every 8 weeks until death, assessed up to 24 months|FAS|||months||95% Confidence Interval|Median
2600605|NCT02160041|Secondary|Overall Response (OR) or Partial Response (PR) or Greater|"The key secondary endpoint, OR, was determined by Investigator assessment for each tumor assessment and defined as responses of CR and PR per RECIST version 1.1.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"|baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months|FAS|||participants||95% Confidence Interval|Number
2600606|NCT02160041|Primary|Clinical Benefit Rate (CBR) Associated With BGJ398 Treatment|"Tumor Response: Overall response rate (ORR) and clinical benefit rate (CBR) for solid tumor (non-lymphoma) which excludes 3 TIO and 1 Lymphoma patients (hence 80 patients and not 84)~Clinical benefit rate for patients with solid tumors were assessed using RECIST 1.1 and include responses of CR or PR or SD. For hematologic tumors other appropriate hematological response criteria may apply~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"|16 weeks|Full Analysis Set (FAS): The FAS included all enrolled patients who received at least 1 dose of study drug. The FAS was the primary set for efficacy analyses.|||Participants|||Count of Participants
2600634|NCT02159950|Secondary|Frequency of Toxicities Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4|The frequency of participants with toxicities will be tabulated by grade across all dose levels and courses.|Up to 3 years|All treated and eligible patients.|||participants|||Number
2600635|NCT02159950|Secondary|Duration of PSA Response||Up to 3 years|Due a Lack of funding data was not collected and no patients were analyzed.||||||
2600607|NCT02160002|Post-Hoc|Growth Velocity (g/kg/Day) After Transfer to Crib From Incubator to Crib to 36 Weeks Postmenstural Age (PMA)|Growth velocity in terms of weight (g/kg/day), considering infant weight at 24 hours after successful wean to crib and weight at 36 weeks postmenstrual age (PMA).|24 hours after successful wean to 36 weeks postmenstrual age (PMA)|257 infants (136 LW, 121 HW) remained in hospital at 36 weeks PMA w/ weight measured at 36 weeks PMA. 26 (10 LW, 16 HW) were still in incubator at 36 weeks PMA, 31 (16 LW, 15 HW) were missing weight after 24 hrs of successful wean, and 4 (LW) w/ weights measured at 24 hrs after successful wean were missing date of 24 hr weight after successful wean|||grams/kilograms/day||Standard Deviation|Mean
2600608|NCT02160002|Secondary|Length of Stay (LOS) Following Randomization to Hospital Discharge|The number of days the infant stayed in hospital after randomization to the study until discharge.|From randomization through discharge.|185 infants in the Lower Weight group and 178 infants in the Higher Weight group have the date of discharge.|||days||Inter-Quartile Range|Median
2600609|NCT02160002|Secondary|Transferred to a Non-Network Hospital|Number of infants transferred to another non-Network hospital.|Status (discharge, death, transfer to another facility, or 120 days)|185 infants in the Lower Weight group and 178 infants in the Higher Weight group have status data.|||Participants|||Count of Participants
2600610|NCT02160002|Secondary|Death Among Enrolled Infants||Status (discharge, death, transfer to another facility, or 120 days)|185 infants in the Lower Weight group and 178 infants in the Higher Weight group have status data.|||Participants|||Count of Participants
2600611|NCT02160002|Secondary|Readmission to the Hospital Within 1 Week of Discharge|Number of infants re-hospitalized within 1 week (7 days) of discharge.|Discharge through 1 week after discharge.|174 infants in the Lower Weight group and 168 infants in the Higher Weight group had post discharge follow-up.|||Participants|||Count of Participants
2600612|NCT02160002|Secondary|Postmenstrual Age (PMA) at Discharge|Postmenstrual age (PMA) at discharge is the sum of the gestational age of the infant and its length of stay in hospital from birth to discharge.|Discharge|185 infants in the Lower Weight group and 178 infants in the Higher Weight group have postmenstrual age (PMA) at discharge data.|||weeks||Inter-Quartile Range|Median
2600613|NCT02160002|Secondary|Growth Parameters: Head Circumference at Status|Infant head circumference at status is measured at the time of discharge, death, transfer to another facility, or 120 days.|Status (discharge, death, transfer to another facility, or 120 days)|182 infants in the Lower Weight group and 173 infants in the Higher Weight group have the head circumference at status data.|||centimeters||Standard Deviation|Mean
2600614|NCT02160002|Secondary|Growth Parameters: Length at Status|Infant length at status is measured at the time of discharge, death, transfer to another facility, or 120 days.|Status (discharge, death, transfer to another facility, or 120 days)|174 infants in the Lower Weight group and 169 infants in the Higher Weight group have the length at status data.|||centimeters||Standard Deviation|Mean
2600615|NCT02160002|Secondary|Growth Parameters: Weight at Status|Infant weight at status is measured at the time of discharge, death, transfer to another facility, or 120 days.|Status (discharge, death, transfer to another facility, or 120 days)|185 infants in the Lower Weight group and 177 infants in the Higher Weight group had their weights recorded upon reaching status.|||grams||Standard Deviation|Mean
2600616|NCT02160002|Secondary|Growth Velocity (Weight in Grams/kg/Day) From Start of Weaning From Incubator (Following Random Assignment) to 36 Weeks Postmenstrual Age (PMA)|Growth velocity in terms of weight (g/kg/day), considering infant weight at start of weaning from incubator to crib (following random assignment) and weight at 36 weeks postmenstrual age (PMA).|Start of weaning from incubator through 36 weeks postmenstrual age (PMA)|There were 257 (136 LW and 121 HW) infants who remained in the hospital at 36 weeks PMA that have weights measured at 36 weeks PMA. Twenty six infants (10 LW and 16 HW) who were still in the incubator at 36 weeks PMA and 20 infants (7 LW and 13 HW) missing the date of start of weaning were excluded from the analysis.|||grams/kilograms/day||Standard Deviation|Mean
2600617|NCT02160002|Secondary|Failure Rate of Weaning to Crib (Number of Infants With Axillary Temperature < 36.3°C After 2 Weaning Attempts)|Failure of wean is defined as axillary temperature less than 36.3°C after one hour in the crib on 2 successive readings, 3 to 4 hours apart, within 24 hours of weaning to the crib in spite of additional clothes/coverings.|Through completion of 2 weaning attempts|178 infants in the Lower Weight group and 167 infants in the Higher Weight group have the data on whether weaning from incubator to crib was successful after two attempts at weaning.|||Participants|||Count of Participants
2600618|NCT02160002|Secondary|Length of Stay (LOS) Following Weaning From Incubator to Crib to Hospital Discharge (up to 120 Days)|Among infants who were successfully weaned, the number of days in the hospital counting from the start of weaning from the incubator to the crib through discharge from the hospital (up to 120 days).|From start of weaning from the incubator to crib through discharge (up to 120 days)|There were 163 infants in the Lower Weight group that were successfully weaned from incubator to the crib; discharge date was missing for one of these infants. There were 159 infants in the Higher Weight group that were successfully weaned from incubator to the crib; 4 infants were missing start of weaning dates because of protocol violations.|||days||Inter-Quartile Range|Median
2600619|NCT02160002|Primary|Length of Hospital Stay (LOS) From Birth to Discharge (up to 120 Days)|Number of days the infant stays in hospital after birth until discharge home (up to 120 days).|From birth through discharge|185 infants in the lower weight group and 178 infants in the higher weight group have the date of discharge available.|||days||Inter-Quartile Range|Median
2600620|NCT02159976|Secondary|Functional Dyspepsia Symptom Responses Rate||1 year after termination of eradication therapy|SQT and PBAT were used for the initial treatment. Thereafter, treatment success and treatment failure group were divided. In the treatment failure group, secondary treatment was performed. Secondary endpoints were functional and dyspepsia symptom responses rate after successful treatment, not success in both treatment groups.|||Participants|||Count of Participants
2600621|NCT02159976|Secondary|Counts of Participants With Adverse Event||4 weeks after termination of eradication therapy, up to 6 weeks||||Participants|||Count of Participants
2600622|NCT02159976|Secondary|Counts of Participants Whose Drug Compliance is More Than 85%||4 weeks after termination of eradication therapy, up to 6 weeks||||Participants|||Count of Participants
2600623|NCT02159976|Primary|Counts of Participants With Successful H. Pylori Eradication||4 weeks after termination of eradication therapy, up to 6 weeks||||Participants|||Count of Participants
2600638|NCT02159898|Secondary|GERD-HRQL|"Evaluate symptoms of gastric reflux as assessed by Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) instrument at 4 weeks following treatment.~Scale:~0 = No symptom~= Symptoms noticeable but not bothersome~= Symptoms noticeable and bothersome but not every day~= Symptoms bothersome every day~= Symptoms affect daily activity~= Symptoms are incapacitating to do daily activities"|4 Weeks Following Treament|Results at week 4, number of patients analyzed differs from baseline due to inability to continue to follow the patients due to death or lost to follow up.|||units on a scale||Standard Deviation|Mean
2600639|NCT02159898|Primary|Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment|"The primary endpoint is to evaluate improvement of dysphagia due to esophageal strictures at 2 weeks following treatment.~Scale:~0 = able to eat normal diet / no dysphagia.~= able to swallow some solid foods~= able to swallow only semi solid foods~= able to swallow liquids only~= unable to swallow anything / total dysphagia"|2 Weeks Following Treatment|1 patient was randomized but not treated and other patients are not included|||units on a scale||Standard Deviation|Mean
2600640|NCT02159859|Other Pre-specified|Number of Participants With Any Adverse Events|Evaluation of any adverse events will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital|Up to seven days after the administration of ertapenem||||Participants|||Count of Participants
2600641|NCT02159859|Secondary|Number of Participants With Injection Site Reaction|Evaluation of injection site reaction will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital|Up to seven days after the administration of ertapenem||||Participants|||Count of Participants
2600642|NCT02159859|Secondary|Number of Participants With Headache|Evaluation of headache will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital|Up to seven days after the administration of ertapenem||||Participants|||Count of Participants
2600643|NCT02159859|Secondary|Number of Participants With Nausea and Vomiting|Evaluation of nausea and vomiting will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital|Up to seven days after the administration of ertapenem||||Participants|||Count of Participants
2600644|NCT02159859|Secondary|Number of Participants With Diarrhea|Evaluation of diarrhea will be performed by the study physician at screening, predose, 24 hours, and 5 to 7 days after the ertapenem dose or the last day of patient's stay in the hospital|Up to seven days after the administration of ertapenem||||Participants|||Count of Participants
2600645|NCT02159859|Primary|Mean Time to Cmax of Ertapenem in Hemodialysis Patients|Mean time to Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session||||hours||Standard Deviation|Mean
2600646|NCT02159859|Primary|Mean Terminal Half Life (t1/2) of Ertpenem in Hemodialysis Patients|Mean t1/2 will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session||||hours||Standard Deviation|Mean
2600647|NCT02159859|Primary|Mean Area Under the Curve (AUC) of Ertapenem in Hemodialysis Patients|Mean AUC will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session||||h*ug/mL||Standard Deviation|Mean
2600648|NCT02159859|Primary|Mean Minimum Concentration (Cmin) of Ertapenem in Hemodialysis Patients|Mean Cmin will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session||||mcg/ml||Standard Deviation|Mean
2600649|NCT02159859|Primary|Mean Maximum Concentration (Cmax) of Ertapenem in Hemodialysis Patients|Mean Cmax will be calculated from a series of ertapenem concentration from the blood samples, i.e.once after hemodialysis session prior to ertapenem administration, and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session|once after hemodialysis session prior to ertapenem administration and at 0.5, 1, 2, 6, 12 hours after the administration of one gram ertapenem over five minutes, and once before the next hemodialysis session||||mcg/ml||Standard Deviation|Mean
2600650|NCT02159807|Secondary|Mean Change in Visual Analog Scale for Pain|Mean change of her pain relief from the spinal epidural 60 minutes after she received it, using a VAS, scored from 0 to 10, with higher score indicating more pain.|baseline and 60 minutes||||score on a scale||Standard Deviation|Mean
2600651|NCT02159807|Secondary|Fetal Heart Rate at 1 Hour|Baby's heart rate recorded with the external monitor that is placed on patient's belly, for a duration of 60 minutes after the placement of the combined spinal epidural.|at 1 hour||||beats per minute||Standard Deviation|Mean
2600652|NCT02159807|Primary|Maternal Blood Pressure|Maternal diastolic blood pressure at 60 minutes after epidural to measure maternal hypotension|at 1 hour||||mm/Hg||Standard Deviation|Mean
2600722|NCT02159079|Primary|ICU-free Days to 14 Days After Enrollment|The primary outcome will be the number of ICU-free days to day 14 (defined as the number days alive and outside of the intensive care unit in the first 14 days after enrollment).|14 days||||days||Inter-Quartile Range|Median
2600653|NCT02159768|Secondary|Transmission of Airtraq View of Larynx|The view of the larynx will be captured by the handphone attached to the Airtraq layryngoscope, and then transmitted to a second investigator.|Intra operative measurement, time frame within 5 minutes|The larynx could be visualized in all 30 patients using the handphone attached to the Airtraq. The images of the larynx could be transmitted to a remote assistant in all 30 patients.|||participants|||Number
2600654|NCT02159768|Primary|Visualization of Larynx With the Airtraq Laryngoscope and Handphone|The efficacy of viewing the larynx via the handphone attached to the Airtraq laryngoscope will be assessed.|Intra operative|Study participants in whom the Airtraq handphone visualization system was studied|||participants|||Number
2600655|NCT02159729|Primary|Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits|"The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).~The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).~Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis."|Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)|Analysis population included all who received study treatment from a previous study, and who were composite SMFRS 2-Grade Responders at LTFU Baseline|||percentage of participants|||Number
2600656|NCT02159729|Primary|Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits|"The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).~The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).~Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis."|Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)|Analysis population included all who received study treatment from a previous study, and who were composite SMFRS 1-Grade Responders at LTFU Baseline|||percentage of participants|||Number
2600657|NCT02159729|Primary|Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits|"The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).~Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis."|Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)|Analysis population included all who received study treatment from a previous study, and who were PR-SMFRS 1-Grade Responders at LTFU Baseline|||percentage of participants|||Number
2600658|NCT02159729|Primary|Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 5 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits|"The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).~Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis."|Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)|Analysis population included all who received study treatment from a previous study, and who were CR-SMFRS 1-Grade Responders at LTFU Baseline|||percentage of participants|||Number
2600659|NCT02159703|Primary|Percentage of Participants With Local Control||2 years||||percentage of patients||95% Confidence Interval|Number
2600660|NCT02159547|Secondary|Adverse Effects|The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes.|45th minutes||||participants|||Number
2600661|NCT02159547|Primary|Visual Analogue Scale Change|Change from baseline in Visual Analogue Scale, 100 mm, at 45th minutes. Visual Analogue Scale is measurement tool scoring tool between 0 (no pain) and 100 mm (worst pain). Minimum clinically significant change in pain score is 13 or 16 mm.|45 minutes||||units on a scale||95% Confidence Interval|Median
2600662|NCT02159521|Secondary|Number of Participants Who Had Adverse Events (AEs), Related (to the Study Procedure/Device/Medications) AEs, and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A summary of non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline (within 30 days of treatment) up to Day 30|ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated.|||Participants|||Count of Participants
2600663|NCT02159521|Secondary|Number of Participants Who Died Due to Any Cause|Number of participants who died due to any cause for up to 365 days following the conclusion of the study procedure, were reported.|Baseline (within 30 days of treatment) up to Day 365|ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated.|||Participants|||Count of Participants
2600664|NCT02159521|Secondary|Number of Participants Who Had Symptomatic PE During Hospitalization for Study Procedure|Symptomatic PE was diagnosed using computed tomography pulmonary angiogram (CTPA), single positron emission computed tomography (SPECT), and ventilation-perfusion (VQ).|From starting the initial thrombolytic infusion (Day 0) through discharge from hospital (up to Day 38)|ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated.|||Participants|||Count of Participants
2600688|NCT02159352|Secondary|Number of Participants With Abnormalities in Electrocardiogram (ECG) Findings|Abnormalities in ECG findings included: PR ≥210 msec, QRS ≥120 msec, QT ≥500 msec, QTcF ≥450 msec, and second- or third-degree heart block.|From start of study treatment (Day 1) to study discharge (up to 15 days)|All participants who received at least 1 dose of study drug|||participants|||Number
2600665|NCT02159521|Secondary|Time From Starting Initial Thrombolytic Infusion to Discharge From the Hospital|This Outcome Measure was to measure the time that the participant's initial thrombolytic infusion started to the time the participant was discharged from the hospital.|From the time of the EkoSonic® procedure (Day 0) up to 365 days|ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated.|||days||Full Range|Median
2600666|NCT02159521|Secondary|Number of Participants With PTS-induced Admission to an Emergency Room or Unplanned Visits to a Physician's Office or Hospitalization|Number of participants with PTS-induced admission to an emergency room or unplanned visits to a physician's office or hospitalization, are reported. A participant can have more than one PTS-induced health issue.|From the time of the EkoSonic® procedure (Day 0) up to 365 days|ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated.|||Participants|||Count of Participants
2600667|NCT02159521|Secondary|Change From Baseline in Venous Clinical Severity Score (VCSS) in Study Leg at Days 30, 90, 180, and 365|The VCSS system includes 10 clinical descriptions (pain, varicose veins, venous edema, skin pigmentation, inflammation, induration, number of active ulcers, duration of active ulceration, size of active ulceration, and level of compliance with medical compression therapy), scored from 0 to 3 (total possible score, 30) with 0 = absent, 1 = mild, 2 = moderate and 3 = severe. Total VCSS was the sum of all VCSS assessment scores from categories for a given time point. Total score ranged from 0 (absent) to 30 (severe). Lower values represent a better outcome, that is, a level of pain less than that experienced at baseline.|Baseline (within 30 days of treatment), Days 30, 90, 180, and 365|ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated. Here, 'Number analyzed' signifies number of limbs and the number of participants analyzed at specified timepoints.|||units on a scale|Limbs|Standard Deviation|Mean
2600668|NCT02159521|Secondary|Change From Baseline in Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) Score At Days 30, 90, 180, and 360|The VEINES-QOL/Sym is a participant-based questionnaire designed for self-completion and measures deep vein thrombosis (DVT) impact on symptoms and quality of life from the participants' perspective. It contains 26 items covering participant DVT: symptoms, limitations in daily activities, and psychological impact. A separate summary score VEINES-QOL ranges from 0 (worst quality of life) to 100 (best quality of life). Higher scores indicated a better quality of life.|Baseline (within 30 days of treatment), Days 30, 90, 180, and 365|ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated. Here, ‘Overall number of participants analyzed’ signifies participants evaluable for this outcome measure and ‘Number analyzed’ signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2600669|NCT02159521|Secondary|Number of Treated Limbs With Shift From Baseline in Clinical Stages (Symptomatic and Asymptomatic) of Clinical, Etiologic, Anatomic, Pathophysiological (CEAP) Classification at Days 30, 90, 180, and 365|Status of clinical signs and symptoms of lower limb venous disease was measured by CEAP classification. The CEAP clinical Categories were as follows: C0- no visible or palpable signs of venous disease, C1- telangiectasies or reticular veins, C2- varicose veins, C3- edema, C4a- pigmentation and eczema, C4b- lipodermatosclerosis and atrophie blanche, C5- healed venous ulcer, and C6- active venous ulcer. C0 was of the least clinical concern and C6 was the worst stage. Each clinical class was further characterized by the (clinical stages) presence or absence of symptoms (ache, pain, tightness, skin irritation, heaviness, muscle cramps, as well as other complaints attributable to venous dysfunction): asymptomatic and symptomatic.|Baseline (within 30 days of treatment), Days 30, 90, 180, and 365|ITT population included all enrolled participants for whom EkoSonic® treatment was initiated. Here, ‘Overall number of participants analyzed’/'Overall Number of Units Analyzed' signifies the number of participants/units evaluable for this outcome measure and 'Number analyzed' signifies number of limbs/participants analyzed at specified timepoints.|||Limbs|Limbs||Count of Units
2600670|NCT02159521|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Sub-Scale Score and Physical Component Score (PCS) at Days, 30, 90, 180, and 365|SF- 36 investigates the standard of quality of life through a general health assessment. It is a 36-item questionnaire measuring 8 domains (physical functioning [PF], role physical [RP], bodily pain [BP], general health [GH], vitality [VT], social functioning [SF], role emotional [RE], and mental health [MH]). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. The PCS score summarizes the subscales physical functioning, role-physical, bodily pain, and general health. Total score range for PCS was 0 (lowest level of physical functioning) to 100 (highest level of physical functioning).|Baseline (within 30 days of treatment), Days 30, 90, 180, and 365|ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated. Here, 'Number analyzed' signifies number of limbs and the number of participants analyzed at specified timepoints.|||units on a scale|Limbs|Standard Deviation|Mean
2600671|NCT02159521|Secondary|Percentage of Treated Veins Segments of Limbs With Absence of Re-Occlusion, as Documented by Duplex Imaging|Absence of re-occlusion in following treated veins has been reported: common femoral vein (CFV), common iliac vein (CIV), distal femoral vein (FV), external iliac vein (EIV), popliteal vein, and proximal femoral vein (FV).|Day 365|ITT population included all enrolled participants for whom EkoSonic® treatment was initiated. Here, ‘Overall number of participants analyzed’/'Overall Number of Units Analyzed' signifies the number of participants/units evaluable for this outcome measure and 'Number analyzed' signifies number of limbs/participants analyzed at specified timepoints.|||percentage of segments|Vein segments||Number
2600689|NCT02159352|Secondary|Number of Participants With Abnormalities in Vital Sign Measurements|Criteria for abnormalities in vital sign measurements: Diastolic blood pressure: Value >90 and change from baseline > 0 or value < 55 and change from baseline <-10. Systolic blood pressure: Value >140 and change from baseline >20 or value <90 and change from baseline <-20. Heart rate: Value >100 and change from baseline >30 or value <55 and change from baseline <-15. Respiration: Value >16 or change from baseline >10. Temperature: Value >38.3°C or change from baseline >1.6°C.|From start of study treatment (Day 1) to study discharge (up to 15 days)|Participants who received at least 1 dose of study drug|||participants|||Number
2600705|NCT02159183|Secondary|Sulcus Bleeding Index (According to Mombelli et al 1987)|"The inflammatory status of the mucosa will be evaluated by means of a UNC 15 periodontal probe.~0: No bleeding when a periodontal probe is passed along the peri-implant sulcus~Isolated bleeding spots are recognizable~Confluent bleeding line along the marginal mucosa~Profound bleeding."|3 years|Per-Protocol Analysis|||Sites on teeth|Sites on teeth||Number
2600672|NCT02159521|Secondary|Percentage of Segments of Limbs That Achieved at Least 4-Point Reduction From Baseline in Villalta Score at Days 90, 180, and 365|Limbs with revascularization procedures were considered non-responders. Villalta scale (post thrombotic syndrome score) is used for the assessment of symptoms and clinical signs. Participants rated the following symptoms for each leg: pain, cramps, heaviness, pruritus, and paresthesia on a scale ranging from 0 (not present/minimal) to 3 (severe). The study coordinator or nurse rated the following clinical signs in participants for each leg: pre-tibial edema, induration of the skin, hyperpigmentation, new venous extasia, redness during calf compression, and pain during calf compression on a scale ranging from 0 (not present/minimal) to 3 (severe). Total score ranged from 0 to 33. Higher scores represent more severe disease.|Baseline (within 30 days of treatment), Days 90, 180, and 365|ITT population included all enrolled participants for whom EkoSonic® treatment was initiated. Here, ‘Overall number of participants analyzed’/'Overall Number of Units Analyzed' signifies the number of participants/units evaluable for this outcome measure and 'Number analyzed' signifies number of limbs/participants analyzed at specified timepoints.|||percentage of segments|Limbs|95% Confidence Interval|Number
2600673|NCT02159521|Secondary|Change From Baseline in Villalta Score at Days 90, 180, and 365 Post-EkoSonic® Study Treatment Procedure|Villalta scale (post thrombotic syndrome score) is used for the assessment of symptoms and clinical signs. Participants rated the following symptoms for each leg: pain, cramps, heaviness, pruritus, and paresthesia on a scale ranging from 0 (not present/minimal) to 3 (severe). The study coordinator or nurse rated the following clinical signs in participants for each leg: pre-tibial edema, induration of the skin, hyperpigmentation, new venous extasia, redness during calf compression, and pain during calf compression on a scale ranging from 0 (not present/minimal) to 3 (severe). Total score ranged from 0 to 33. Higher scores represent more severe disease.|Baseline (within 30 days of treatment), Days 90, 180, and 365|ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated. Here, 'Number analyzed' signifies number of limbs and the number of participants analyzed at specified timepoints.|||units on a scale|Limbs|Standard Deviation|Mean
2600674|NCT02159521|Secondary|Number of Participants With at Least 5-Point Reduction From Baseline in Ouriel Score at Post-Adjunctive Therapy|The Ouriel score was designed to provide a more accurate quantitative estimate of the thrombus mass by calculating a volumetric index for all the venous segments. 14 venous segments were considered. Included segments were the inferior vena cava, common iliac veins, external iliac veins, internal iliac veins, common femoral veins, superficial femoral veins, deep femoral veins, and popliteal veins and segments of the anterior tibial veins, posterior tibial veins, and peroneal veins. A normalized volumetric score was calculated for each segment by combining measurements from computed tomography, ultrasonography, and venography. Partially occluded veins were assigned a score of one-half the score value for the segment. The score varies from 1 for a single calf vein to 26 for the infrarenal inferior vena cava. The maximum score was 63 per limb. Higher score indicated worse disease prognoses.|Baseline (Within 30 days of treatment), Day 0|ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated. Here, ‘Number analyzed’ signifies number of participants analyzed.|||Participants|||Count of Participants
2600675|NCT02159521|Secondary|Change From Baseline in Ouriel Score (Venous Volumetric Index [VVI]) at Post-Adjunctive Therapy|The Ouriel score was designed to provide a more accurate quantitative estimate of the thrombus mass by calculating a volumetric index for all the venous segments. 10 venous segments were considered. Included segments were the inferior vena cava, common iliac veins, external iliac veins, internal iliac veins, common femoral veins, superficial and deep femoral veins, and popliteal veins and segments of the anterior tibial veins, posterior tibial veins, and peroneal veins. A normalized volumetric score was calculated for each segment by combining measurements from computed tomography, ultrasonography, and venography. Partially occluded veins were assigned a score of one-half the score value for the segment. The score varies from 1 for a single calf vein to 26 for the infrarenal inferior vena cava. The maximum score was 63 per limb. Higher score indicated worse disease prognoses.|Baseline (Within 30 days of treatment), Day 0|ITT population included all enrolled participants for whom EkoSonic® treatment was initiated. Here, ‘Overall number of participants analyzed’/'Overall Number of Units Analyzed' signifies the number of participants/units evaluable for this outcome measure and 'Number analyzed' signifies number of limbs/participants analyzed at specified timepoints.|||units on a scale|Limbs|Standard Deviation|Mean
2600676|NCT02159521|Primary|Number of Participants With Major Bleeding|Major bleeding was defined as: Fatal bleeding; and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; and/or bleeding causing a fall in hemoglobin of ≥2.0 grams/deciliter (g/dL), or leading to transfusion of ≥2 units of whole blood or red blood cells. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|From start of study drug infusion up to 72 hours|ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated.|||Participants|||Count of Participants
2600677|NCT02159521|Primary|Change From Baseline in Blood Flow (Calculated by Time to Washout in the Affected Segment) at Post-Adjunctive Therapy|Change in blood flow was calculated by time to washout in the affected segments in the participants. Time to femoral vein (FV) washout and external iliac vein (EIV) washout was reported.|Baseline (Within 30 days of treatment), Day 0|ITT population included all enrolled participants for whom EkoSonic® treatment was initiated. Here, ‘Overall number of participants analyzed’/'Overall Number of Units Analyzed' signifies the number of participants/units evaluable for this outcome measure and 'Number analyzed' signifies number of limbs/participants analyzed at specified timepoints.|||seconds|Limbs|Standard Deviation|Mean
2600690|NCT02159352|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From start of study treatment (Day 1) to study discharge for AEs (up to 15 days); Day 1 to 30 days after last dose of study treatment for SAEs (up to 44 days)|All participants who received at least 1 dose of study drug|||participants|||Number
2600678|NCT02159521|Primary|Percentage of Segments of Limbs That Achieved at Least 4-Point Reduction From Baseline in Villalta Score at Day 30|Clinical efficacy was evaluated using the Villalta score at Baseline compared to 30 days Post-EkoSonic® study treatment procedure. Limbs with revascularization procedures were considered non-responders. Villalta scale (post thrombotic syndrome score) is used for the assessment of symptoms and clinical signs. Participants rated the following symptoms for each leg: pain, cramps, heaviness, pruritus, and paresthesia on a scale ranging from 0 (not present/minimal) to 3 (severe). The study coordinator or nurse rated the following clinical signs in participants for each leg: pre-tibial edema, induration of the skin, hyperpigmentation, new venous extasia, redness during calf compression, and pain during calf compression on a scale ranging from 0 (not present/minimal) to 3 (severe). Total score ranged from 0 to 33. Higher scores represent more severe disease.|Baseline (within 30 days of treatment), Day 30|ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||percentage of segments|Limbs|95% Confidence Interval|Number
2600679|NCT02159521|Primary|Change From Baseline in Villalta Score at Day 30 Post-EkoSonic® Study Treatment Procedure|Clinical efficacy was evaluated using the Villalta score at Baseline compared to 30 days Post-EkoSonic® study treatment procedure. Villalta scale (post thrombotic syndrome score) is used for the assessment of symptoms and clinical signs. Participants rated the following symptoms for each leg: pain, cramps, heaviness, pruritus, and paresthesia on a scale ranging from 0 (not present/minimal) to 3 (severe). The study coordinator or nurse rated the following clinical signs in participants for each leg: pre-tibial edema, induration of the skin, hyperpigmentation, new venous extasia, redness during calf compression, and pain during calf compression on a scale ranging from 0 (not present/minimal) to 3 (severe). Total score ranged from 0 to 33. Higher scores represent more severe disease.|Baseline (within 30 days of treatment), Day 30|ITT population included all enrolled participants for whom the EkoSonic® treatment was initiated. Here, 'Number analyzed' signifies number of limbs analyzed at specified timepoints.|||units on a scale|Limbs|Standard Deviation|Mean
2600680|NCT02159482|Secondary|Proportion of Patients Experiencing an Increase in the Magnitude of the Tumor Antigen-specific Immune Response|The proportion of patients experiencing an increase in the magnitude of the tumor antigen-specific immune response following the administration of interferon will also be estimated. Immune response will be determined by ELISPOT analysis.|4 weeks|Five subjects analysed due to one subject not completing blood draws.|||percentage of participants|||Number
2600681|NCT02159482|Primary|Proportion of Clinical Responders (Complete Response + Partial Response)|Response determination will be made according to the RECIST criteria. Complete response defined as the disappearance of target lesion, confirmed at 1-4 weeks. Partial response defined as 30% decrease in longest dimension of target lesion, confirmed at 1-4 weeks.|4 weeks||||percentage of participants|||Number
2600682|NCT02159469|Secondary|Safety and Tolerability|"Incidence of adverse events throughout the study~Incidence and severity of injection site reactions throughout the study"|52 weeks|TEAE (Treatment-emergent adverse event)s were defined as any event that started on or after the first dosing of IP (Investigational Product), or existed prior to the first dose and worsened in severity or relatedness to IP after dosing. The Population consisted of all patients who received at least 1 dose of the investigational product.|||Participants|||Count of Participants
2600683|NCT02159469|Primary|Percentage of Patients With Total Testosterone Cavg(0-168h) Serum Concentrations Within the Normal Range (300-1100 ng/dL)|The primary objective of this study was to demonstrate the efficacy of QST (QuickShot Testosterone) administered subcutaneously once each week to adult males with hypogonadism.|12 weeks|The Population consisted of all patients who received at least 1 dose of the investigational product. Percentage was calculated using the number of patients in the column heading as the denominator.|||Participants|||Count of Participants
2600684|NCT02159365|Secondary|Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period|An infusion reaction in this study is defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.|Date of first dose up to 60 days post last dose (approximately 4 years)|All treated participants|||Participants|||Count of Participants
2600685|NCT02159365|Primary|Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2|Infusion reaction was defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.|From Day 1 to End of cycle 2 treatment (approximately 56 days)|All Treated Participants|||Participants||95% Confidence Interval|Number
2600686|NCT02159352|Secondary|Number of Participants With Abnormalities in Urinalysis and Other Chemistry Testing Results|Criteria for marked abnormalities on laboratory test results: urinary dipstick blood: ≥2 if pretreatment (PreRx) <1, ≥2 if PreRx is missing or ≥2*PreRx if PreRx ≥1. Urinary microscopic red blood cell (RBC): ≥2 if PreRx <2, ≥2 if PreRx is missing or ≥4 if PreRx ≥2. Urinary microscopic white blood cell (WBC): ≥2 if PreRx <2, ≥2 if PreRx is missing or ≥4 if PreRx ≥2. Lactate dehydrogenase >1.25*upper limit of normal (ULN) if PreRx ≤ULN, >1.25*ULN if PreRx is missing and >1.5*PreRx if PreRx >ULN.|From start of study treatment (Day 1) to study discharge (up to 15 days)|All treated participants.|||participants|||Number
2600687|NCT02159352|Secondary|Number of Participants With Marked Abnormalities in Hematology Laboratory Test Results|Criteria for marked abnormalities in test results: Platelet count >1.5*upper limits of normal (ULN) value, >1.5*ULN if pretreatment (PreRx) value is missing, <0.85*lower limit of normal (LLN) if PreRx ≥LLN, <0.85*LLN if PreRx is missing, <0.85*PreRx if PreRx <LLN. Leukocytes >1.2*ULN if LLN ≤PreRx ≤ULN, >1.2*ULN if PreRx is missing, >1.5*PreRx if PreRx >ULN, >ULN if PreRx <LLN, <0.85*PreRx if PreRx <LLN, <0.9*LLN if LLN ≤PreRx ≤ULN, <0.9*LLN if PreRx is missing and <LLN if PreRx >ULN. Lymphocytes >7.5*10^3 c/uL and <0.75*10^3 c/uL. Neutrophils <0.85*PreRx if PreRx <1.5*ULN, <1.5*ULN if PreRx ≥1.5*ULN and <1.5*ULN if PreRx is missing.|From start of study treatment (Day 1) to study discharge (up to 15 days)|All treated participants.|||participants|||Number
2600719|NCT02159079|Secondary|Renal Replacement Therapy-free Days to Day 14|Renal replacement therapy-free days to day 14 (defined as the number of days alive and free of renal replacement therapy from the last receipt of renal replacement therapy after enrollment to study day 14)|14 days||||days||Inter-Quartile Range|Median
2600691|NCT02159352|Secondary|Dose-normalized Area Under the Concentration-Time Curve in 1 Dosing Interval (AUC[TAU]/D) of Daclatasvir|AUC(TAU)/D was obtained from concentration-time plot of daclatasvir by using noncompartmental method by a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profile. Here, N signifies number of participants evaluable for this outcome measure.|||(ng*h/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
2600692|NCT02159352|Secondary|Dose-normalized Maximum Observed Plasma Concentration (Cmax/D) and Dose-normalized Plasma Concentration Observed at 24 Hours Postdose (C24/D) of Daclatasvir|Cmax/D and C24/D are obtained from concentration-time plot of daclatasvir by using noncompartmental method by a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profile.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2600693|NCT02159352|Secondary|Plasma Concentration Observed at 24 Hours Postdose (C24) of Daclatasvir|C24 was obtained from concentration time plot of daclatasvir by using noncompartmental method by a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profile. Here, N signifies number of participants evaluable for this outcome measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2600694|NCT02159352|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Daclatasvir|Tmax was obtained from concentration-time plot of daclatasvir by using non-compartmental method by a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profile. Here, N signifies number of participants evaluable for this outcome measure.|||hours||Full Range|Median
2600695|NCT02159352|Primary|Area Under the Concentration-Time Curve in 1 Dosing Interval (AUC[TAU]) for Daclatasvir|AUC(TAU) was the area under the curve from time zero to end of dosing interval. AUC(TAU) was obtained from concentration-time plot of daclatasvir using noncompartmental method and a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profiles. Number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2600696|NCT02159352|Primary|Maximum Observed Plasma Concentration (Cmax) for Daclatasvir|Cmax was obtained from concentration-time plot using a noncompartmental method and a validated pharmacokinetic analysis program.|Predose (0 hour) on Day 2, 3 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hours on Day 4 (Period 1); Predose (0 hour) on Day 12, 13 and 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 hour on Day 14 (Period 2)|All treated participants with adequate pharmacokinetic profiles.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2600697|NCT02159183|Secondary|Adverse Events|All subjects are monitored continuously for adverse event.|up to 3 years|ITT Analysis.|||Participants|||Count of Participants
2600698|NCT02159183|Secondary|Dental Implant Success and Implant Loss|The implant success will be defined according to Buser et al 1990. Overall evaluation of implant success.|3 years|Intention to Treat (ITT) Analysis|||Participants|||Count of Participants
2600699|NCT02159183|Secondary|Bone Crest Levels. Bone Levels (mm) - Average Over Mesial+Distal Measurements|"Periapical radiographs are used to measure changes in mesial and distal bone crest levels (of the implant) from baseline (final loading) to one (1) year and three (3) years, respectively.~The parameter derives from the subtraction of mesial and distal bone level linear x-ray measurements. The distance between the alveolar bone at the level of the first radiographic bone contact with the implant surface, and the shoulder of the implant will be measured to the closest 0.1mm at the mesial and distal surfaces of all implants on digitized standardized periapical x-rays using an image analysis computer programme. Bone levels are averaged over mesial+distal measurements. Since bone levels were measured from the implant shoulder, an increase in bone level over time corresponds to bone loss."|1 and 3 years|Per-Protocol Analysis. Missing data of some of the patients|||mm||Standard Deviation|Mean
2600700|NCT02159183|Secondary|Clinical Attachment Level (CAL)|"The CAL will be measured from the crown margin to the bottom of the periimplant pocket by means of an UNC 15 probe.~Clinical attachment level (mm) - average over buccal, palatal, distal and mesial measurements"|6 months, 1 and 3 years|Per-Protocol Analysis. Missing data of some of the patients|||mm||Standard Deviation|Mean
2600701|NCT02159183|Secondary|Probing Pocket Depth (PPD)|"The PPD will be measured from the mucosal margin to the bottom of the periimplant pocket by means of an UNC 15 probe.~Probing pocket depth (mm) - average over buccal, palatal, distal and mesial measurements."|6 months, 1 and 3 years|Per-Protocol Analysis. Missing data of some of the patients|||mm||Standard Deviation|Mean
2600702|NCT02159183|Secondary|Recession of Gingival Margin Buccally and Lingually/Palatal|The recession of the gingival margin will be measured (distance from the gingival margin to the crown/implant margin) by using an UNC 15 periodontal probe. Changes in (averaged) recession at the follow-up visits 12+36 months compared to baseline visit ( final loading ) are displayed|1 and 3 years|Per protocol Analysis. Missing data of some patients.|||mm||Standard Deviation|Mean
2600703|NCT02159183|Secondary|Oral Hygiene|Full mouth plaque index (FMPI) and full mouth bleeding on probing index (FMBoP) will be recorded as an indicator for the Oral Hygiene. The indexes are given in percent [%] calculated as the total numbers of surfaces with plaque or bleeding divided by the total number of teeth surfaces x100.|Screening, 6, 12, 36 months|Per-protocol analysis. Missing data on some patients|||percentage of surfaces||Standard Deviation|Mean
2600704|NCT02159183|Secondary|Soft Tissue Healing Evaluation|Assessment of the wound healing by classifying the implantation site (normal or compromised healing).|10 days and 12 weeks||||participants|||Number
2600706|NCT02159183|Primary|Sulcus Bleeding Index (According to Mombelli et al 1987)|"The primary endpoint is the difference of Sulcus Bleeding Index (according to Mombelli et al 1987) between baseline (final loading) and 12 months.~The inflammatory status of the mucosa will be evaluated by means of a UNC 15 periodontal probe.~0: No bleeding when a periodontal probe is passed along the peri-implant sulcus~Isolated bleeding spots are recognizable~Confluent bleeding line along the marginal mucosa~Profound bleeding."|12 months|per protocol analysis|||sites on teeth|sites on teeth||Count of Units
2600707|NCT02159118|Secondary|Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Biopsy Specimen Acquisition Using the Manual Device and the Powered Device|measurement of the amount of time required to acquire one bone marrow biopsy specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the biopsy specimen has been collected.|at time of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.|||seconds||Standard Deviation|Mean
2600708|NCT02159118|Secondary|Operator Satisfaction With Manual Device and Powered Device|Device operators will report their level of satisfaction with use of the manual device and the powered device to perform the bone marrow sampling procedure. Level of satisfaction is reported using a 0 to 10 scale, where higher numbers represent a higher level of satisfaction.|Within 24 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis as the requires sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.|||units on a scale||Standard Deviation|Mean
2600709|NCT02159118|Secondary|Patient Level of Post-procedural Pain Following Use of the Manual Device and the Powered Device|Within 4 hours of the bone marrow sampling procedure, the patient will report their level of pain post-procedure using the Wong-Baker FACES pain rating scale. The scale measures pain from 0-10, where higher numbers represent worse pain.|within 4 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.|||units on a scale||Standard Deviation|Mean
2600710|NCT02159118|Secondary|Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Aspiration Specimen Acquisition Using the Manual Device and the Powered Device|measurement of the amount of time required to acquire a bone marrow aspiration specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the aspiration specimen has been collected.|at time of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.|||seconds||Standard Deviation|Mean
2600711|NCT02159118|Secondary|Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device|number of needle passes required to capture one bone marrow biopsy specimen using the manual device and the powered device|at time of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.|||needle passes|Participants|Standard Deviation|Mean
2600712|NCT02159118|Secondary|Bone Marrow Biopsy Specimen Size (Volume) Obtained Using the Manual Device and the Powered Device|bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for volume|within 24 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.|||mm3||Standard Deviation|Mean
2600713|NCT02159118|Secondary|Bone Marrow Biopsy Specimen Size (Width) Obtained Using the Manual Device and the Powered Device|bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for width.|within 24 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.|||mm||Standard Deviation|Mean
2600714|NCT02159118|Secondary|Bone Marrow Biopsy Specimen Size (Length) Obtained Using the Manual Device and the Powered Device|bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for length.|within 24 hours of the bone marrow sampling procedure|All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.|||mm||Standard Deviation|Mean
2600715|NCT02159118|Primary|Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device|Bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for percent of hematopoietic tissue present. Higher percentage of hematopoietic tissue present in a biopsy specimen indicates a larger quantity of specimen for pathological evaluation.|within 24 hours of bone marrow sampling procedure|All participants enrolled in the study were included in analysis, as the required sample size for the study was met. No subjects were excluded from analysis. Analysis was made per protocol.|||% Hematopoetic tissue present||Standard Deviation|Mean
2600716|NCT02159079|Secondary|Receipt of Renal Replacement Therapy|receipt of renal replacement therapy between enrollment and the first of 28 days or hospital discharge|28 days||||Participants|||Count of Participants
2600717|NCT02159079|Secondary|Highest Plasma Creatinine Between Enrollment and 28 Days After Enrollment|Highest plasma creatinine (mg/dL) between enrollment and 28 days after enrollment, censored at hospital discharge|28 days||||mg/dL||Inter-Quartile Range|Median
2600718|NCT02159079|Secondary|Highest Stage of Acute Kidney Injury|Highest stage of acute kidney injury as defined according to Kidney Disease Improving Global Outcomes (KDIGO) criteria Stage 0 (no acute kidney injury) Stage 1 Serum creatinine 1.5-1.9 times baseline or ≥0.3 mg/dl (≥26.5 mmol/l) increase or Urine output <0.5 ml/kg/h for 6-12 hours Stage 2 Serum creatinine 2.0-2.9 times baseline or <0.5 ml/kg/h for ≥12 hours Stage 3 Serum creatinine 3.0 times baseline or Increase in serum creatinine to ≥4.0 mg/dl (≥353.6 mmol/l) or Initiation of renal replacement therapy or in patients <18 years, decrease in eGFR to <35 ml/min per 1.73 m² or Urine output <0.3 ml/kg/h for ≥24 hours or anuria for ≥12 hours|28 days||||Participants|||Count of Participants
2601642|NCT02150954|Secondary|Time to Foley Expulsion or Removal|Time from foley balloon placement until the expulsion or removal of the foley balloon.|foley bulb placement until removal, up to 10 hours||||hours||Inter-Quartile Range|Median
2600723|NCT02159053|Secondary|Percentage of Participants Responded for ASAS 40 Response at Week 4|"ASAS 20 response is a validated composite assessment, defined as an improvement of at least 40% and 2 unit on a scale of 10 in three main domains and no worsening at all in the remaining domain within a defined time frame. Four main ASAS domains include:~Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe~Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain~Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale~Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem)."|Week 4|"The analysis was performed in FAS population. Here, Number of participants analysed signifies participants evaluable for ASAS 40 response at Week 16."|||percentage of participants||95% Confidence Interval|Number
2600724|NCT02159053|Secondary|Percentage of Participants Responded for ASAS 20 at Week 4|"ASAS 20 response is a validated composite assessment, defined as an improvement of at least 20% and 1 unit on a scale of 10 in three main domains and no worsening of at least 20% and 1 unit on a scale of 10 in the fourth domain within a defined time frame. Four main ASAS domains include:~Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe~Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain~Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale~Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem)."|Week 4|"The analysis was performed in FAS population. Here, Number of participants analysed signifies participants evaluable for ASAS 20 at Week 16."|||percentage of participants||95% Confidence Interval|Number
2600725|NCT02159053|Secondary|Number of Participants With Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs) and Related Discontinuations at 104 Weeks|AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.|104 Weeks|The analysis was performed on the safety population, defined as all participants who took at least one dose of study treatment during the treatment period.|||participants|||Number
2600726|NCT02159053|Secondary|Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at 16 Weeks|ASQoL is a self-administered 18 item questionnaire that assesses disease-specific quality of life (QoL), consisting of statements that are relevant to the physical and mental conditions for a subject with ankylosing spondylitis: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score ranges from 0 (good QoL) to 18 (poor QoL). The change in ASQoL scores was evaluated using a mixed effect repeated measures model (MMRM).|Baseline, 16 Weeks|"The analysis was performed in FAS population. Here, Number of participants analysed signifies participants evaluable for ASQoL at Week 16."|||units on a scale||Standard Deviation|Mean
2600727|NCT02159053|Secondary|Change From Baseline in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36)|SF-36 is a 36 item questionnaire which measures Quality of Life across eight subscales that were scored individually: physical functioning, role- physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Scores are weighted sums of the questions in each section. Scores range from 0-100. Lower scores = more disability, higher scores = less disability. The overall summary scores, SF-36 physical Component Summary (PCS) was used to assess improvement from baseline in the Health-Related Quality Of Life of subjects. The change in SF-36 scores were evaluated using MMRM.|Baseline, 16 Weeks|"The analysis was performed in FAS population.Here, Number of participants analysed signifies participants evaluable for PCS of the SF-36 at Week 16."|||scores on a scale||Standard Deviation|Mean
2600728|NCT02159053|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 16 Weeks|"BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating no problem and 10 indicating worst problem on continuous VAS), to answer 6 questions (clinical domains) pertaining to 5 major symptoms of ankylosing spondylitis. Computed composite scores of 4 or greater indicate suboptimal disease control. BASDAI questions includes:~Fatigue~Spinal pain~Joint pain / swelling~Areas of localized tenderness (called enthesitis, or inflammation of tendons and ligaments)~Morning stiffness duration~Morning stiffness severity. Each symptom has equal weighting, the mean of two scores related to morning stiffness was taken (questions 5 and 6). The resulting 0 to 10 score was added to the scores from questions 1-4. The resulting 0 to 50 score was divided by 5 to give a final 0-10 BASDAI score. BASDAI was a quick and simple index taking between 30 seconds and 2 minutes for completion."|Baseline, 16 Weeks|"The analysis was performed in FAS population. Here, Number of participants analysed signifies participants evaluable for BASDAI at Week 16."|||units on a scale||Standard Deviation|Mean
2600729|NCT02159053|Secondary|Percentage of Participants Responded for ASAS 5/6 Response at 16 Weeks|"ASAS 5/6 response is a validated composite assessment, defined as an improvement of at least 20% in score in at least 5 of 6 clinical domains relevant to ankylosing spondylitis and no worsening in the remaining domain. ASAS domains includes:~Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe~Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain~Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale~Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem)~Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment~C-reactive protein (CRP, acute phase reactant)."|16 Weeks|"The analysis was performed in FAS population. Here, Number of participants analysed signifies participants evaluable for ASAS 5/6 response at Week 16."|||percentage of participants||95% Confidence Interval|Number
2618713|NCT01969214|Secondary|Time (Hours) From the First Intake to the Last Watery Stool|The last watery stool was assumed as the first-non watery stool|96 hours||||Hours||Standard Deviation|Mean
2600730|NCT02159053|Secondary|Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at 16 Weeks|Blood levels of C-reactive protein (CRP) is an acute phase reactant, which are indicative of inflammation and of its severity, and can be used to monitor treatment response. A hsCRP test is implemented to assess the efficacy of secukinumab (with or without load) versus placebo in reducing ankylosing spondylitis elicited systemic inflammation over the time.|Baseline, 16 Weeks|"The analysis was performed in FAS population. Here, Number of participants analysed signifies participants evaluable for hsCRP at Week 16."|||Ratio||Standard Deviation|Mean
2600731|NCT02159053|Secondary|Percentage of Participants Responded for ASAS 40 Response at 16 Weeks|"ASAS 20 response is a validated composite assessment, defined as an improvement of at least 40% and 2 unit on a scale of 10 in three main domains and no worsening at all in the remaining domain within a defined time frame. Four main ASAS domains include:~Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe~Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain~Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale~Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem)."|16 Weeks|"The analysis was performed in FAS population. Here, Number of participants analysed signifies participants evaluable for ASAS 40 response at Week 16."|||percentage of participants||95% Confidence Interval|Number
2600732|NCT02159053|Primary|Percentage of Participants Responded for Assessment of Spondyloarthritis International Society 20 Criteria (ASAS20) at 16 Weeks|ASAS 20 response is a validated composite assessment, defined as an improvement of at least 20 percent (%) and 1 unit on a scale of 10 in three main domains and no worsening of at least 20% and 1 unit on a scale of 10 in the fourth domain within a defined time frame. Four main ASAS domains include: 1. Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe 2. Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain to unbearable pain 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions regarding ability to perform specific tasks as measured by a 0-10 VAS scale 4. Inflammation represented by average of duration and severity of morning stiffness for last 2 questions on BASDAI scale (0 - no problem, 10 - worst problem)|16 Weeks|"The analysis was performed in Full analysis set (FAS) population, defined as all participants who were randomized and received study treatment. Here, Number of participants analysed signifies participants evaluable for ASAS20 at Week 16."|||percentage of participants||95% Confidence Interval|Number
2600733|NCT02159040|Secondary|Prevalence of MDS/AML Related Gene Mutations|Prevalence of the following mutations in the study population (TP53, EZH2, ETV6, RUNX1, ASXL1, other mutation that is present in ≥ 5% of patients)|Baseline|Only one patient in trial. No analysis will ever be done.||||||
2600734|NCT02159040|Secondary|Rate of Infection|Median number of infections (positive bacterial, viral or fungal culture, or infection requiring IV antimicrobial, or infection resulting in hospitalization or death) in patients treated with azacitidine alone vs. azacitidine + deferasirox|up to 24 months|Only one patient in trial. No analysis will ever be done.||||||
2600735|NCT02159040|Secondary|Incidence of Adverse Events|Incidence of adverse events (AEs) overall and by severity, and serious adverse events (SAEs).|up to 24 months|Only one patient in trial. No analysis will ever be done.||||||
2600736|NCT02159040|Secondary|Change in Serum Ferritin|Change in Serum Ferritin|up to 24 months|Only one patient in trial. No analysis will ever be done.||||||
2600737|NCT02159040|Secondary|Time to AML Transformation|Time to AML transformation is defined as time from the date of the first dose of study treatment to the date of the first documented bone marrow blast count ≥ 20% per WHO classification 1999.|Up to 24 months|Only one patient in trial. No analysis will ever be done.||||||
2600738|NCT02159040|Secondary|Overall Survival|Overall survival is defined as time from the date of the first dose of study treatment to the date of death from any cause.|up to 24 months|Only one patient in trial. No analysis will ever be done.||||||
2600739|NCT02159040|Secondary|Progression Free Survival|Progression free survival is defined as time from the date of the first dose of study treatment to the date of the first documented disease progression or relapse per IWG 2006 criteria.|Up to 24 months|Only one patient in trial. No analysis will ever be done.||||||
2600740|NCT02159040|Secondary|Duration of Response|Duration of response is defined as time from the date of the first observed hematologic improvement to the date of the first subsequent documented disease progression or relapse per IWG 2006 criteria.|up to 24 months|Only one patient in trial. No analysis will ever be done.||||||
2600741|NCT02159040|Secondary|Time to Response|Time to response is defined as time from the date of the first dose of study treatment to the date of the first documented hematologic improvement.|up to 24 months|Only one patient in trial. No analysis will ever be done.||||||
2600742|NCT02159040|Primary|Overall Response Rate Per IWG 2006 Criteria|ORR (inclusive of CR, PR and HI) per IWG 2006 criteria including erythroid response, platelet response and neutrophil response over the course of one year. Hematologic improvement must be maintained for at least 8 weeks in order to count as HI.|1 year|Only one patient in trial. No analysis will ever be done.||||||
2600743|NCT02158975|Secondary|Duration of Response|Time from documentation of tumor response to disease progression.|24 months after initiation of study treatment|Although 12 patients were analyzable, only one patient responded to treatment and therefore only 1 patient is represented for the duration of response.|||months|||Number
2600744|NCT02158975|Secondary|Median Overall Survival Time|Overall Survival (OS) is defined as the time from study start until death.|24 months after initiation of study treatment|Five patients died between start of treatment and database lock. Patients who were alive at the time of the database lock (March 31st, 2017) were administratively censored.|||months||95% Confidence Interval|Median
2600745|NCT02158975|Secondary|Median Progression Free Survival Time|Progression Free Survival (PFS) is defined as the time from study start until disease progression or death.|24 months after initiation of study treatment|5 of the 12 patients withdrew prior to progression and therefore progression free survival was censored at their time of withdraw.|||months||95% Confidence Interval|Median
2600746|NCT02158975|Secondary|Number Patients That Experience Adverse Events, Grades 3-5|To assess the safety and tolerability of MLN9708, the number of patients experiencing Adverse Events (AEs) greater than or equal to grade 3 will be recorded.|30 days after the last dose of study drug||||participants|||Number
2600747|NCT02158975|Primary|Objective Response Rate|The percentage of patients with an objective response rate will be determined. The overall response will be based on response in each compartment (skin, blood, lymph nodes and viscera) using a global composite scoring system. Objective response is considered (CR) Complete Response (Complete disappearance of all clinical evidence of disease), CRu (Complete Response Unconfirmed), or (PR) Partial Response (Regression of measurable disease).|Up to 24 months after initiation of study treatment|12 analyzable patients|||percentage of patients||95% Confidence Interval|Number
2600748|NCT02158936|Secondary|Cmax -Pharmacokinetic Parameter of Azacitidine|An analysis of variance (ANOVA) on Cmax . The PK parameters were log transformed prior to analysis. The model included treatment as a fixed effect. Point estimates and their associated 90% CI were constructed for the differences in PK parameter values. The point estimates and their associated 90% CI were then back transformed to provide point estimates and 90% CI for the azacitidine + ltrombopag:azacitidine + placebo PK parameter ratios.|Cycle 2 Day 1: Pre-dose, 15 min, 0.5, 1, 2 and 4 hr post dose|All patients with evaluable azacitidine dosing, actual sampling time, and azacitidine concentration data were included in the NCA dataset and analysis|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2600749|NCT02158936|Secondary|AUC0-infinity -Pharmacokinetic(s) Parameter of Azacitidine|An analysis of variance (ANOVA) on AUC0-infinity. The PK parameters were log transformed prior to analysis. The model included treatment as a fixed effect. Point estimates and their associated 90% CI were constructed for the differences in PK parameter values. The point estimates and their associated 90% CI were then back transformed to provide point estimates and 90% CI for the azacitidine + eltrombopag:azacitidine + placebo PK parameter ratios.|Cycle 2 Day 1: Pre-dose, 15 min, 0.5, 1, 2 and 4 hr post dose|all patients with evaluable azacitidine dosing, actual sampling time, and azacitidine concentration data were included in the NCA dataset and analysis|||hr.ng/mL||Geometric Coefficient of Variation|Geometric Mean
2600750|NCT02158936|Secondary|Summary of Post-Hoc Estimates of Steady-state Eltrombopag AUC0 Infinity Pharmacokinetic Parameters for a 50 mg Dose|Eltrombopag concentrations were analyzed using a population PK model along with data from other studies in healthy volunteers and in patients with MDS and/or AML. Post-hoc PK parameters were derived. Only patients from this study were included (163)|Cycle 1, Week 2: Pre-dose, 1.5 and 3 hour post dose; Cycle 1, Week 3: 4, 5.5, and 7 hours post dose|All patients with evaluable eltrombopag dosing, actual sampling time, and eltrombopag concentration data were included in the population PK dataset and analysis.|||hr.μg/mL||Geometric Coefficient of Variation|Geometric Mean
2600751|NCT02158936|Secondary|Summary of Post-Hoc Estimates of Steady-state Eltrombopag Cmax and Cmin Pharmacokinetic Parameters for a 50 mg Dose|Eltrombopag concentrations were analyzed using a population PK model along with data from other studies in healthy volunteers and in patients with MDS and/or AML. Post-hoc PK parameters were derived. Only patients from this study were included (163)|Cycle 1, Week 2: Pre-dose, 1.5 and 3 hour post dose; Cycle 1, Week 3: 4, 5.5, and 7 hours post dose|All patients with evaluable eltrombopag dosing, actual sampling time, and eltrombopag concentration data were included in the population PK dataset and analysis.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2600752|NCT02158936|Secondary|Medical Resource Utilization (MRU): Use of Site Specific Medical Resources|MRU data will be collected for each subject. Events corresponding to unscheduled (not scheduled per protocol) hospitalizations, office visits including consultations, laboratory and diagnostic tests (lab results, imaging etc.), and procedures prior to therapy initiation and during therapy will be collected|From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years||||visits|||Number
2600753|NCT02158936|Secondary|Medical Resource Utilization (MRU): Event and Use of Site Specific Medical Resources - Non-study Laboratory Tests|MRU data will be collected for each subject. Events corresponding to unscheduled (not scheduled per protocol) hospitalizations, office visits including consultations, laboratory and diagnostic tests (lab results, imaging etc.), and procedures prior to therapy initiation and during therapy will be collected|From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years||||tests|||Number
2600754|NCT02158936|Secondary|Medical Resource Utilization (MRU): Event -Hospitalizations Inpatient and Outpatient|MRU data will be collected for each subject. Events corresponding to unscheduled (not scheduled per protocol) hospitalizations|From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years||||days||Standard Deviation|Mean
2600755|NCT02158936|Secondary|Functional Assessment of Chronic Disease Therapy-fatigue Subscale (FACIT-Fatigue) (ITT)|"The FACIT-Fatigue subscale measures severity and impact of fatigue on functioning and Health Related QoL experienced in the past 7 days. Scale is a 13 item measure of fatigure. Items are scored on a 0-4 response scale ranging from not at all to very much so. All items are summed to create a single fatigure score with a range from 0 to 52. Items are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatiigue (The FACIT Fatigue Scale is owned by David Cella, Ph.D.)"|From Day 1 to 4-week follow-up (Approximate median 9 Cycles+4 weeks follow-up) up to approximately 2 years||||scores||Standard Deviation|Mean
2600756|NCT02158936|Secondary|Response Levels in All Domains of Euroquol-5 Dimensions of Health, 3 Response Levels (EQ-5D-3L™)|The EQ-5D is a general health status and health utility measure which captures 5 dimensions of health state: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. (EQ-5D is a trademark of the Stichting EuroQol Group) . C=cycle, D=Day|From Day 1 to 4-week follow-up up to approximately 2 years||||participant|||Number
2600757|NCT02158936|Secondary|Number of of Subjects With Azacitidine Dose Delays, Dose Reductions, Interruptions|The proportion of subjects with any delay, reduction or interruption in dosage of Azacitidine excluding those for non-medical reasons will be analyzed|From Day 1 to 4-week follow-up up to approximately 2 years||||participant|||Number
2600758|NCT02158936|Secondary|Bleeding Adverse Events (AEs) >= Grade 3|Bleeding will be assessed by recording AEs or serious adverse events (SAEs) as graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0|From Day 1 to 4-week follow-up up to approximately 2 years||||participant|||Number
2600759|NCT02158936|Secondary|Number of Participants Who Were Platelet Transfusion Independent (ITT Set)|Platelet transfusion independence is defined for each cycle as the number of participants who continue to the end of a cycle without requiring a platelet transfusion|From Day 1 to end of study treatment up to approximately 2 years||||participants|||Number
2600760|NCT02158936|Secondary|Hematologic Improvement (HI) in Platelets, Neutrophils, and Hemoglobin Based on the Modified IWG Criteria for MDS (ITT)|HI based on the modified IWG criteria for MDS. HI - Platelets (BL <100Gi/L), response criteria= BL <20: increase to>20 and 100% at least for 56 days or BL >=20: absolute increase of >=30. HI - Neutrophils (BL <1.0 Gi/L), response criteria=100% increase and an absolute increase >0.5 Gi/L over BL for at least 56 days. HI-Hemoglobin (BL <g/dL), response criteria=Hgb increase by >=1.5 g/dL over BL, RBC transfusions(given for Hgb<=9.0) reduced by >=4 per 8w from BL|From Day 1 to 4-week follow-up (samples collected weekly in Cycle 1, Days 1 and 15 in Cycles 2-6 and Day 1 of Cycles >=7)||||participants|||Number
2600761|NCT02158936|Secondary|Best Disease Response From Central Review (ITT)|Best disease response is categorized as complete remission (CR), partial remission (PR), or marrow CR, stable disease, disease progression, or as non-evaluable; according to modified 2006 International Working Group (IWG) criteria for MDS|At end of Cycle 6 (cycle=28 days) or end of therapy, whichever came first||||participant|||Number
2600762|NCT02158936|Secondary|Best Disease Response From Investigator Assessment (ITT)|Best disease response is categorized as complete remission (CR), partial remission (PR), or marrow CR, stable disease, disease progression, or as non-evaluable; according to modified 2006 International Working Group (IWG) criteria for MDS|At end of Cycle 6 (cycle=28 days) or end of therapy, whichever came first||||participant|||Number
2600763|NCT02158936|Secondary|Summary of AML Progression From Investigator Assessment and Central Review (ITT)|"Progression to AML in MDS patients with baseline bone marrow blast < 20% was defined as meeting definition of disease progression according to the modified 2006 IWG response criteria for MDS with the additional requirement that bone marrow blast or peripheral blast increases from < 20% at baseline to ≥ 20% postbaseline. Progression assessment For patients with:~Less than 5% BM blasts: ≥ 50% increase in blasts to > 5% blasts; 5% - <10% BM blasts: ≥ 50% increase to > 10% blasts; 10% - <20% BM blasts: ≥ 50% increase to > 20% blasts; 20% - 30% BM blasts: ≥ 50% increase to > 30% blasts"|First day of each cycle (Cycles 3+), at the end of therapy visit and every 3 months in follow-up for approximately 2 years|The intent-to-treat (ITT) population included all the patients randomized in the study|||participants|||Number
2600764|NCT02158936|Secondary|Summary of Progression Free Survival From Central Review (ITT)|"Progression-free survival, defined as the time from randomization until either disease progression or death. The modified 2006 IWG criteria for MDS used for progression assessment For patients with:~Less than 5% BM blasts: ≥ 50% increase in blasts to > 5% blasts; 5% - <10% BM blasts: ≥ 50% increase to > 10% blasts; 10% - <20% BM blasts: ≥ 50% increase to > 20% blasts; 20% - 30% BM blasts: ≥ 50% increase to > 30% blasts"|First day of each cycle (Cycles 3+), at the end of therapy visit and every 3 months in follow-up for approximately 2 years|The intent-to-treat (ITT) population included all the patients randomized in the study|||participants|||Number
2600765|NCT02158936|Secondary|Summary of Progression Free Survival From Investigator Assessment (ITT)|Progression-free survival, defined as the time from randomization until either disease progression or death. The modified 2006 IWG criteria for MDS used for progression assessment For patients with: Less than 5% BM blasts: ≥ 50% increase in blasts to > 5% blasts; 5% - <10% BM blasts: ≥ 50% increase to > 10% blasts; 10% - <20% BM blasts: ≥ 50% increase to > 20% blasts; 20% - 30% BM blasts: ≥ 50% increase to > 30% blasts|First day of each cycle (Cycles 3+), at the end of therapy visit and every 3 months in follow-up for approximately 2 years|The intent-to-treat (ITT) population included all the patients randomized in the study|||participants|||Number
2600766|NCT02158936|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization until death due to any cause and deaths have been presented. Subjects still alive at the time of the analysis and subjects who have withdrawn from the study will be censored at the time of last contact|Randomization until death or end of study, approximately 2 years||||deaths (events)|||Number
2600767|NCT02158936|Primary|Number of Participants Who Were Platelet Transfusion Independent During Cycles 1-4 of Azacitidine Therapy|A subject is defined as being platelet transfusion independent if they received no platelet transfusions within the first 4 cycles of treatment with azacitidine. Subjects who died or withdrew from investigational product within the first four cycles were treated as failures (i.e. not transfusion independent) in the analysis|4 cycles (Cycle = 28 days)|Intent-to-Treat population, comprised of all randomized patients|||Participants|||Number
2600768|NCT02158884|Primary|Veterans RAND 12 Item Health Survey (VR-12) - Mental Health Component Summary (MCS)|The Veterans RAND 12 Item Health Survey (VR-12) is a participant reported global health measure assessing the participant's overall perspective of their health status. Responses are summarized into 2 scores, a Physical Component Score (PCS) and a Mental Component Score (MCS). Scored on a 5 point Likert scale, the 12 items correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The United States population averages 50 points on both the PCS and MCS (scores may range from 0-100). The United States population standard deviation is 10 points. Higher scores indicate better outcomes.|12 months|91 consented at 3 military treatment facilities & received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions & were excluded from analysis; of the 81 completing RTR, 10 missed performance assessment & 7 did not complete patient reported outcome surveys, leaving 64 in the 12 month analysis.|||score on a scale||Standard Deviation|Mean
2600769|NCT02158884|Primary|Veterans RAND 12 Item Health Survey (VR-12) - Physical Component Summary (PCS)|The Veterans RAND 12 Item Health Survey (VR-12) is a participant reported global health measure assessing the participant's overall perspective of their health status. Responses are summarized into 2 scores, a Physical Component Score (PCS) and a Mental Component Score (MCS). Scored on a 5 point Likert scale, the 12 items correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The United States population averages 50 points on both the PCS and MCS (scores may range from 0-100 on each). The United States population standard deviation is 10 points. Higher scores indicate better outcomes.|12 months|91 consented at 3 military treatment facilities and received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions & were excluded from analysis; of the 81 completing RTR, 10 missed performance assessment & 7 did not complete patient reported outcome surveys, leaving 64 in the 12 month analysis|||score on a scale||Standard Deviation|Mean
2600770|NCT02158884|Primary|Short Musculoskeletal Function Assessment (SMFA) - Emotional Status|The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100|12 months|91 consented at 3 military treatment facilities and received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions & were excluded from analysis; of the 81 completing RTR, 10 missed performance assessment & 7 did not complete patient reported outcome surveys, leaving 64 in the 12 month analysis|||score on a scale||Standard Deviation|Mean
2600771|NCT02158884|Primary|Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function|The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100|12 months|91 consented at 3 military treatment facilities and received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions & were excluded from analysis; of the 81 completing RTR, 10 missed performance assessment & 7 did not complete patient reported outcome surveys, leaving 64 in the 12 month analysis|||score on a scale||Standard Deviation|Mean
2600772|NCT02158884|Primary|Short Musculoskeletal Function Assessment (SMFA) - Daily Activities|The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100|12 months|91 consented at 3 military treatment facilities and received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions & were excluded from analysis; of the 81 completing RTR, 10 missed performance assessment & 7 did not complete patient reported outcome surveys, leaving 64 in the 12 month analysis|||score on a scale||Standard Deviation|Mean
2600773|NCT02158884|Primary|Short Musculoskeletal Function Assessment (SMFA) - Mobility|The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100|12 months|91 consented at 3 military treatment facilities and received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions & were excluded from analysis; of the 81 completing RTR, 10 missed performance assessment & 7 did not complete patient reported outcome surveys, leaving 64 in the 12 month analysis|||score on a scale||Standard Deviation|Mean
2600774|NCT02158884|Primary|Short Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction|The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100|12 months|91 consented at 3 military treatment facilities and received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions & were excluded from analysis; of the 81 completing RTR, 10 missed performance assessment & 7 did not complete patient reported outcome surveys, leaving 64 in the 12 month analysis|||score on a scale||Standard Deviation|Mean
2600775|NCT02158884|Primary|Veterans RAND 12 Item Health Survey (VR-12) Mental Health Component Summary (MCS)|The Veterans RAND 12 Item Health Survey (VR-12) is a participant reported global health measure assessing the participant's overall perspective of their health status. Responses are summarized into 2 scores, a Physical Component Score (PCS) (range 0-100) and a Mental Component Score (MCS) (range 0-100). The 12 items correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Higher scores indicate better outcomes.|6 months|91 consented at 3 military treatment facilities &received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions & were excluded from analysis; of the 81 completing RTR, 10 did not do a performance assessment & 10 missed patient reported outcome surveys leaving 61 in the 6 month analysis.|||score on a scale||Standard Deviation|Mean
2600776|NCT02158884|Primary|Veterans RAND 12 Item Health Survey (VR-12) - Physical Component Summary (PCS)|The Veterans RAND 12 Item Health Survey (VR-12) is a participant reported global health measure assessing the participant's overall perspective of their health status. Responses are summarized into 2 scores, a Physical Component Score (PCS) (range 0-100) and a Mental Component Score (MCS) (range 0-100). The 12 items correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Higher scores indicate better outcomes.|6 months|91 consented at 3 military treatment facilities &received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions & were excluded from analysis; of the 81 completing RTR, 10 did not do a performance assessment & 10 missed patient reported outcome surveys leaving 61 in the 6 month analysis.|||score on a scale||Standard Deviation|Mean
2600777|NCT02158884|Primary|Short Musculoskeletal Function Assessment (SMFA) - Emotional Status|The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100.|6 months|91 consented at 3 military treatment facilities &received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions & were excluded from analysis; of the 81 completing RTR, 10 did not do a performance assessment & 10 missed patient reported outcome surveys leaving 61 in the 6 month analysis.|||score on a scale||Standard Deviation|Mean
2600778|NCT02158884|Primary|Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function|The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100.|6 months|91 consented at 3 military treatment facilities &received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions & were excluded from analysis; of the 81 completing RTR, 10 did not do a performance assessment & 10 missed patient reported outcome surveys leaving 61 in the 6 month analysis..|||score on a scale||Standard Deviation|Mean
2600779|NCT02158884|Primary|Short Musculoskeletal Function Assessment (SMFA) - Daily Activities|The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100.|6 months|91 consented at 3 military treatment facilities &received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions & were excluded from analysis; of the 81 completing RTR, 10 did not do a performance assessment & 10 missed patient reported outcome surveys leaving 61 in the 6 month analysis.|||score on a scale||Standard Deviation|Mean
2600780|NCT02158884|Primary|Short Musculoskeletal Function Assessment (SMFA) - Mobility|The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100.|6 months|91 consented at 3 military treatment facilities &received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions & were excluded from analysis; of the 81 completing RTR, 10 did not do a performance assessment & 10 missed patient reported outcome surveys leaving 61 in the 6 month analysis.|||score on a scale||Standard Deviation|Mean
2600781|NCT02158884|Primary|Short Musculoskeletal Function Assessment (SMFA) - Overall Dysfunction|The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100.|6 months|91 consented at 3 military treatment facilities &received an IDEO (87 had complete baseline assessments). Of the 87, 6 (6.7%) did not participate in RTR PT sessions & were excluded from analysis; of the 81 completing RTR, 10 did not do a performance assessment & 10 missed patient reported outcome surveys leaving 61 in the 6 month analysis.|||score on a scale||Standard Deviation|Mean
2600782|NCT02158884|Primary|Timed Stair Assent Test|"The Timed Stair Assent test is an objective measure of strength and power. It is measured in seconds, with a range of > 0 ~ +∞. Lower values represent better outcomes. (This measure is part of the change in functional performance composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability)."|Post intervention (approx 4 weeks post IDEO fit)|91 consented at 3 military treatment facilities and received an IDEO. 81 completed the intervention and were included in analysis.|||seconds||Standard Deviation|Mean
2600783|NCT02158884|Primary|Sit to Stand Test|"The Sit to Stand Test is an objective measure of strength and power. It is measured in seconds, with a range of > 0 ~ +∞. Lower values represent better outcomes. (This measure is part of the change in functional performance composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability)."|Post intervention (approx 4 weeks post IDEO fit)|91 consented at 3 military treatment facilities and received an IDEO. 81 completed the intervention and were included in analysis.|||seconds||Standard Deviation|Mean
2600784|NCT02158884|Primary|Illinois Agility Test|"The Illinois Agility Test is an objective measure of agility. It is measured in seconds, with a range of > 0 ~ +∞. Lower values represent better outcomes. (This measure is part of the change in functional performance composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability)"|Post intervention (approx 4 weeks post IDEO fit)|91 consented at 3 military treatment facilities and received an IDEO. 81 completed the intervention and were included in analysis.|||seconds||Standard Deviation|Mean
2600819|NCT02158546|Secondary|Proportion of Patients Who Exhibited Treatment Response (MADRS-10)|The proportion of subjects demonstrating MADRS-10 treatment response, defined as a ≥ 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (week 6).|6 weeks|The FAS consists of subjects in the Group 1 Safety Population who have at least 1 post-randomization assessment of MADRS total score.|||Participants|||Count of Participants
2600785|NCT02158884|Primary|4 Step Square Test|The 4 step square test is an objective measure of agility. It is measured in seconds, with a range of > 0 ~ +∞. Lower values represent better outcomes. (This measure is part of the change in functional performance composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability)|Post intervention (approx 4 weeks post IDEO fit)|91 consented at 3 military treatment facilities and received an IDEO. 81 completed the intervention and were included in analysis.|||seconds||Standard Deviation|Mean
2600786|NCT02158884|Primary|Veterans RAND 12 Item Health Survey (VR-12) - Mental Health Component Summary|The Veterans RAND 12 Item Health Survey (VR-12) is a participant reported global health measure assessing the participant's overall perspective of their health status. Responses are summarized into 2 scores, a Physical Component Score (PCS) (range 0-100) and a Mental Component Score (MCS) (range 0-100). The 12 items correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Higher scores indicate better outcomes.|Baseline|91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.|||score on a scale||Standard Deviation|Mean
2600787|NCT02158884|Primary|Veterans RAND 12 Item Health Survey - Physical Component Summary|The Veterans RAND 12 Item Health Survey (VR-12) is a participant reported global health measure assessing the participant's overall perspective of their health status. Responses are summarized into 2 scores, a Physical Component Score (PCS) (range 0-100) and a Mental Component Score (MCS) (range 0-100). The 12 items correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Higher scores indicate better outcomes.|Baseline|91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.|||score on a scale||Standard Deviation|Mean
2600788|NCT02158884|Primary|Short Musculoskeletal Function Assessment (SMFA) - Emotional Status|"The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: Scores are standardized. The formula for standardization is:~((Actual total raw score - lowest possible raw score)/possible raw score range) *100"|Baseline|91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.|||score on a scale||Standard Deviation|Mean
2600789|NCT02158884|Primary|Short Musculoskeletal Function Assessment (SMFA) - Hand and Arm Function|The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is:|Baseline|91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.|||score on a scale||Standard Deviation|Mean
2600790|NCT02158884|Primary|The Short Musculoskeletal Function Assessment (SMFA) - Daily Activities|The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is ((Actual total raw score - lowest possible raw score)/possible raw score range) *100|Baseline|91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.|||score on a scale||Standard Deviation|Mean
2600791|NCT02158884|Primary|Short Musculoskeletal Function Assessment (SMFA) - Mobility|The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100|Baseline|91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.|||score on a scale||Standard Deviation|Mean
2600792|NCT02158884|Primary|Short Musculoskeletal Function Assessment (SMFA) Overall Dysfunction (Items 1-34)|The Short Musculoskeletal function Assessment (SMFA) is a participant reported assessment of the impact a musculoskeletal condition on individual function and daily activities. This study used Short Musculoskeletal Function Assessment (SMFA) modules for Overall dysfunction, mobility, daily activities, hand and arm function, and emotional status. Scores range is 0-100. Lower scores indicate better function. Scores are standardized; the formula for standardization is: ((Actual total raw score - lowest possible raw score)/possible raw score range) *100|Baseline|91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.|||score on a scale||Standard Deviation|Mean
2600793|NCT02158884|Primary|Shuttle Run|"The Shuttle run test is an objective measure of agility. It is measured in seconds, with a range of > 0 ~ +∞. Higher values represent better outcomes. (The Shuttle run is part of the change in functional performance composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability)"|Baseline|91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.|||seconds||Standard Deviation|Mean
2620692|NCT01953328|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2600794|NCT02158884|Primary|Timed Stair Assent|"The Timed Stair Assent test is an objective measure of strength and power. It is measured in seconds, with a range of > 0 ~ +∞. Lower values represent better outcomes. (The Timed Stair Assent test is part of the change in functional performance composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability)"|Baseline|91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.|||seconds||Standard Deviation|Mean
2600795|NCT02158884|Primary|Sit to Stand Test|"The Sit to Stand test is an objective measure of strength and power. It is measured in seconds, with a range of > 0 ~ +∞. Lower values represent better outcomes. (The Sit to Stand test is part of the change in functional performance composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability)range: > 0 ~ +∞"|Baseline|91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.|||seconds||Standard Deviation|Mean
2600796|NCT02158884|Primary|Baseline Illinois Agility Test|"The Illinois Agility test is an objective measure of agility. It is measured in seconds, with a range of > 0 ~ +∞. Lower values represent better outcomes. (The Illinois Agility test is part of the change in functional performance composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability)"|Baseline|91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.|||seconds||Standard Deviation|Mean
2600797|NCT02158884|Primary|Four Square Step Test|"The 4 step square test is an objective measure of agility. It is measured in seconds, with a range of > 0 ~ +∞. Lower values represent better outcomes. (This measure is part of the change in functional performance composite measure calculated using the mean of participant's score across several objective performance measures of agility, strength and power, speed, and postural stability)."|Baseline|91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.|||seconds||Standard Deviation|Mean
2600798|NCT02158806|Secondary|Incidence of Adverse Events at 24 Weeks|Total number of different types of adverse events in participants who reported with any untoward medical event|24 weeks|Only participants that reported any reported untoward medical event were included in this analysis.|||Number of events|Number of events||Count of Units
2600799|NCT02158806|Secondary|Number of Participants With Adherence to Treatment|Adherence to study medication as measured by pill counts (agreement between expected number of tablets remaining after healing and days to healing)|24 weeks||||Participants|||Count of Participants
2600800|NCT02158806|Secondary|Change in Health-related Quality of Life (Charing Cross Venous Ulcer Questionnaire)|Mean difference in change in Charing Cross Venous Ulcer Questionnaire (CXVUQ)) from baseline to 24 weeks. Crude subscale scores for each group are not shown (each crude subscale is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on the subscales for that group.|24 weeks|Only participants that provided both baseline and endpoint data were included in the analysis. Hence the number of participants included in this analysis is less than the number randomised.|||score on a scale||Standard Error|Mean
2600801|NCT02158806|Secondary|Change in Health-related Quality of Life (EuroQol-5D 3L)|Mean difference in change measured by EuroQol 5D (EQ5D 3L) from baseline to 24 weeks. Crude health state scores for each group are not shown (health state is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on health state for that group.|Baseline, 24 weeks|Only participants that provided both baseline and endpoint data were included in the analysis. Hence the number of participants included in this analysis is less than the number randomised.|||score on a scale||Standard Error|Mean
2600802|NCT02158806|Secondary|Change in Health-related Quality of Life (Short Form 36)|Mean difference in change in Short Form 36 (SF36) from baseline to 24 weeks. Crude subscale scores for each group are not shown (each crude subscale is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on the subscales for that group.|Baseline, 24 weeks|Only participants that provided both baseline and endpoint data were included in the analysis. Hence the number of participants included in this analysis is less than the number randomized.|||units on a scale||Standard Error|Mean
2600803|NCT02158806|Secondary|Change in Estimated Ulcer Area|Change in estimated ulcer area from baseline to 24 weeks|Baseline, 24 weeks|Ulcer area estimated using maximum width and length of the ulcer to calculate the area of an ellipse. We have previously shown this approach to be highly correlated with digital calculation of measured area (r=0.92).|||square centimetres||Standard Error|Mean
2600804|NCT02158806|Secondary|Number of Participants With Healed Venous Leg Ulcers|Number of participants in each arm with completely healed reference ulcers at 24 weeks|24 weeks||||Participants|||Count of Participants
2600805|NCT02158806|Primary|Time to Complete Healing of Reference Ulcer|Time to event (complete healing defined as intact skin with absence of scab)|24 weeks||||days||95% Confidence Interval|Median
2600806|NCT02158728|Primary|Number of Electrocardiograms (ECGs) Collected|Collected were the number of ECGs received from the enrolled subjects, the number of ECGs with SVT (supraventricular tachycardia) episodes, and the number of ECGs with SVT episodes qualified for algorithm development and validation of the potential new ICD. The ECG data were collected continuously during the indicated procedure (ICD/CRT-D implant, ICD/CRT-D change-out, electrophysiology (EP) study (including non invasive EP study)|After recorded ECGs had been received, which were collected until the end of the indicated procedure|Total number of ECGs received from the 80 enrolled subjects.|||ECG|||Number
2600820|NCT02158546|Primary|Change From Baseline to End of Treatment (Week 6) in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.|Baseline and week 6|The Full Analysis Set (FAS) consists of subjects in the Group 1 Safety Population who have at least 1 post-randomization assessment of MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2600807|NCT02158663|Primary|Change in IPF: Inventory of Psychosocial Functioning|Change Inventory of Psychosocial Functioning (IPF) Administered at baseline and after 30 rTMS treatments. The IPF is an 80 question self-report scale that assessed function in the areas of family, work,friendships and socializing, parenting, education, self-care, and romantic relationships with spouse or partner. The rate is based on how often participant acted over the past 30 days. Domains are averaged with resulting score range 1 - 7. 1 Never - 7 Always.|Baseline and after 30 rTMS Treatments (approximately 6 weeks)|There were 44 participants enrolled 35 participants randomized: 22 participants enrolled for 1 Hz group, 5 did not meet randomization/diagnostic criteria. 17 1 Hz participants analyzed showing lower score is better. 22 participants enrolled for 10 Hz group. 4 did not meet randomization/diagnostic criteria. 18 10 Hz participant analyzed.|||score on a scale||Standard Deviation|Mean
2600808|NCT02158663|Primary|Change Clinical-Administered Post Traumatic - DSM-5|Standard administration and scoring of the CAPS-5 are essential for producing reliable and valid scores and diagnostic decisions. Clinical-Administered Post Traumatic -DSM-5 (CAPS-5) 30 items, score ranging from 0-50. CAPS-5 symptom severity ratings are based on symptom frequency and intensity. Intensity rating of Minimal corresponds to a severity rating of Mild/subthreshold, Clearly Present corresponds with Moderate/threshold, Pronounced corresponds with Severe/markedly elevated, and Extreme corresponds with Extreme/ incapacitating. Administered at baseline and after 30 rTMS treatment.|Baseline and after 30 rTMS Treatments (approximately 6 weeks)|There were 44 participants enrolled 35 participants randomized: 22 participants enrolled for 1 Hz group, 5 did not meet randomization/diagnostic criteria. 17 1 Hz participants analyzed showing lower score is better. 22 participants enrolled for 10 Hz group. 4 did not meet randomization/diagnostic criteria. 18 10 Hz participant analyzed.|||score on a scale||Standard Deviation|Mean
2600809|NCT02158572|Other Pre-specified|Cycle Control|Number of episodes of breakthrough bleeding (BTB) and/or breakthrough spotting (BTS) per cycle.|1 year|Subjects that reported BTB and/or BTS|||Episodes/cycle||Standard Deviation|Mean
2600810|NCT02158572|Other Pre-specified|Self-reported Patch Adhesion|"Patch adhesion was reported using the following 5-point scoring method:~0: ≥ 90% adhered (none to minimal lift)~≥ 75% adhered but < 90% (some edges showing lift)~≥ 50% adhered but < 75% (at least half of system lifts off)~< 50% (more than half of the patch lifts off, but the patch remains attached)~Patch completely detached."|1 year|Subjects that reported patch adhesion|||Score||Standard Deviation|Mean
2600811|NCT02158572|Other Pre-specified|Self-reported Skin Itching at Application Site|"Self-reported skin itching at application site was assessed using the following scoring method:~0: None~Mild~Moderate~Severe"|1 year|Subjects who reported itching at the application site|||Score||Standard Deviation|Mean
2600812|NCT02158572|Other Pre-specified|Self-reported Skin Irritation at Application Site|"Self-reported skin irritation at application site was assessed using the following scoring method:~0: None~Mild~Moderate~Severe"|1 year|Subjects who reported irritation at the application site.|||Score||Standard Deviation|Mean
2600813|NCT02158572|Secondary|Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI , PPI|"Contraception efficacy measured by Pearl Index. Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.~PPI dataset: All complete or incomplete on-therapy cycles in which intercourse occurred, excluding the following two cohorts of cycles.~Cohort 1: cycles in which a back-up method of contraception was used for reasons other than the protocol-specified procedures for missed days of patch use, unless pregnancy occurred; and Cohort 2: cycles in which the subject missed ≥ 1 day of patch use and did not adhere to the recommended procedures for missed days of patch use.)"|1 year|PPI population|||Pearl Index||95% Confidence Interval|Number
2600814|NCT02158572|Secondary|Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 30 kg/m2, Per-Protocol-Instructions (PPI) Dataset|"Contraception efficacy measured by Pearl Index. Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.~PPI Efficacy Dataset: All complete or incomplete on-therapy cycles in which intercourse occurred, excluding the following two cohorts of cycles.~Cohort 1: cycles in which a back-up method of contraception was used for reasons other than the protocol-specified procedures for missed days of patch use, unless pregnancy occurred; and Cohort 2: cycles in which the subject missed ≥ 1 day of patch use and did not adhere to the recommended procedures for missed days of patch use.)"|1 year|PPI population|||Pearl Index||95% Confidence Interval|Number
2600815|NCT02158572|Secondary|Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age With BMI < 30 kg/m2, ITT Dataset|Contraception efficacy of AG200-15 by Pearl Index in subjects ≤ 35 years of age with BMI < 30 kg/m2, ITT dataset. Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.|1 year|ITT population: all complete or incomplete on-therapy cycles in which intercourse occurred and no back-up contraception was used.|||Pearl Index||95% Confidence Interval|Number
2600816|NCT02158572|Primary|Contraception Efficacy of AG200-15 in Subjects ≤ 35 Years of Age Regardless of BMI, Intent-to-treat (ITT) Dataset.|The Pearl Index will serve as the primary contraceptive efficacy endpoint for evaluation of pregnancy rates for the study. Pearl Index is the number of on-therapy pregnancies times 1300 divided by the number of 28-day on-therapy cycles and is an estimate of the number of pregnancies per 100 woman-years of product use.|1 year|ITT population: all complete or incomplete on-therapy cycles in which intercourse occurred and no back-up contraception was used.|||Pearl Index||95% Confidence Interval|Number
2600817|NCT02158546|Secondary|Number of Subjects With Adverse Events (AEs)||6 weeks|Safety population consisted of subjects who were identified as placebo non-responders at the end of the double-blind placebo run-in period and received at least one dose of randomized study drug (ie, placebo or ALKS 5461) subsequent to randomization.|||Participants|||Count of Participants
2600818|NCT02158546|Secondary|Remission Rate|The proportion of subjects achieving remission, defined as a MADRS-10 score of ≤ 10 at the end of the efficacy period.|6 weeks|The FAS consists of subjects in the Group 1 Safety Population who have at least 1 post-randomization assessment of MADRS total score.|||Participants|||Count of Participants
2600821|NCT02158533|Secondary|Number of Subjects With Adverse Events (AEs)||5 weeks for Stage 1 and 6 weeks for Stage 2|Safety population consists of all randomized subjects who received at least 1 dose of study drug.|||Participants|||Count of Participants
2600822|NCT02158533|Secondary|Remission Rate|The proportion of subjects achieving remission, defined as a MADRS-10 score of </= 10 at the end of the efficacy period.|Baseline and 5 weeks for each stage|Stage 1 Full Analysis Set (FAS) consisted of subjects who took at least 1 dose of study drug and had at least 1 postbaseline assessment of MADRS in Stage 1. Stage 2 FAS consisted of Stage 1 placebo non-responders who entered Stage 2 and who received at least 1 dose of study drug and had at least 1 postbaseline assessment of MADRS in Stage 2.|||Participants|||Count of Participants
2600823|NCT02158533|Secondary|Proportion of Patients Who Exhibited Treatment Response (MADRS-10)|The proportion of subjects demonstrating MADRS-10 treatment response, defined as a >/= 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (Week 5). The MADRS-10 scale is a measure of the severity of MDD symptoms and includes the following 10 items: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms).|Baseline and 5 weeks for each stage|Stage 1 Full Analysis Set (FAS) consisted of subjects who took at least 1 dose of study drug and had at least 1 postbaseline assessment of MADRS in Stage 1. Stage 2 FAS consisted of Stage 1 placebo non-responders who entered Stage 2 and who received at least 1 dose of study drug and had at least 1 postbaseline assessment of MADRS in Stage 2.|||Participants|||Count of Participants
2600824|NCT02158533|Primary|Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.|Baseline and 5 weeks for each stage|Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline MADRS-10 assessment in the respective stage.|||units on a scale||Standard Error|Least Squares Mean
2600825|NCT02158520|Other Pre-specified|Pharmacokinetic Changes in Paclitaxel Albumin-stabilized Nanoparticle Formulation Plasma Concentrations||Baseline, prior to the end of paclitaxel albumin-stabilized nanoparticle formulation infusion, and the morning after nab-paclitaxel infusion on days 1 and 8 of course 1|||||||
2600826|NCT02158520|Other Pre-specified|Changes in Biomarkers of Immunity||Baseline to up to 5 years|||||||
2600827|NCT02158520|Other Pre-specified|Changes in Biomarkers of Angiogenesis (Arm A)||Baseline to up to 5 years|||||||
2600828|NCT02158520|Secondary|The Number of Patients Who Experienced Toxicity|The number of patients who experienced toxicity (grade 3 or higher adverse events considered at least possibly related to treatment) are reported below.|Up to 4 years||||Participants|||Count of Participants
2600829|NCT02158520|Secondary|Number of Patients With Tumor Response|Tumor response defined as complete or partial response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR): Disappearance of all evidence of disease, Partial response (PR): Regression of measurable disease and no new sites.|Up to 4 years||||Participants|||Count of Participants
2600830|NCT02158520|Secondary|Overall Survival (OS)|Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|From registration to death due to any cause, assessed up to 4 years||||months||95% Confidence Interval|Median
2600831|NCT02158520|Primary|Progression-free Survival (PFS)|Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or a measurable increase in a non-target lesion, or the appearance of new lesions.|From randomization to the earliest documentation of progression as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) or death from any cause without the documentation of progression, assessed up to 4 years||||days||95% Confidence Interval|Median
2600832|NCT02158494|Other Pre-specified|Computerized Video Nystagmography (VNG)|Measures eye movement control under 3 static (x and y axis fixation, spontaneous nystagmus), and 3 dynamic conditions (random saccade, smooth pursuit, optokinetic nystagmus).|Change from Baseline at 2,14, and 26 weeks|||||||
2600833|NCT02158494|Other Pre-specified|Electromyography (EMG)|Measures muscle activation patterns during gait.|Change from Baseline at 2,14, and 26 weeks|||||||
2600834|NCT02158494|Other Pre-specified|Change in Headache Disability Index (HDI) From Baseline|Assesses frequency & severity of headaches via a 25-item questionnaire where an answer of 'yes' = 4 points, 'sometimes' = 2 points, and 'no' = 0 points. The lower the score, the less frequent and severe the symptoms. The range of possible scores is 0 to 100. The results are reported as a change from baseline.|Change from Baseline at 2,14, and 26 weeks||||score on a scale||Standard Deviation|Mean
2600835|NCT02158494|Other Pre-specified|Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline|Subjective inventory of sleep habits, duration and quality. It is scored from 7 components (sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction) to provide a global PSQI score. Most items are scored from 0-3 where 3 is a negative extreme, therefore lower cumulative scores are indicative of improved sleep habits. The total range of scores is from 0-21.|Baseline at 2,14, and 26 weeks||||score on a scale||Standard Deviation|Mean
2600836|NCT02158494|Other Pre-specified|Change in Wechsler Adult Intelligence Scale - Symbol Search and Coding (WAIS-IV) Over Baseline|Assesses visual spatial abilities. The Symbol Search and Coding WAIS-IV subtests measure Processing Speed, an indicator of the rate of cognitive processing and creating an appropriate response output. The tasks require attending to visual material, visual scanning and perception, spatial organization, hand-eye coordination, and paired associative learning. The raw score (processing speed for each test) is converted to a scaled score 1-10 for each and summed for a total possible score of 2-20, the higher the score, the more improved the processing speed. Change in score from baseline to 2, 14, and 26 weeks are reported.|Change from Baseline at 2,14, and 26 weeks||||score on a scale||Standard Deviation|Mean
2600837|NCT02158494|Other Pre-specified|Change in Brief Symptom Inventory 18 (BSI 18) Over Baseline|A short, reliable, 18-question instrument for assessment of psychological distress (anxiety, depression, & somatization) in a clinical population. It is scored from 0-4, with a total range of possible scores 0-72 where higher scores indicate more distress.|Change from Baseline at 2,14, and 26 weeks||||units on a scale||Standard Deviation|Mean
2600838|NCT02158494|Other Pre-specified|Change in California Verbal Learning Test (CVLT) Over Baseline|Assesses short- and long-term verbal memory by evaluating a series of recall and recognition tasks. The test is scored via computer algorithm. A score of 50 represents is equal to the population mean, the normal range is between 40-60 (ie. +/- 1 SD from the mean). The total range of possible scores is 0 (no recalled words) to 100 (all correct). Change in score over baseline at 2, 14, and 26 weeks is reported.|Change from Baseline at 2,14, and 26 weeks||||units on a scale||Standard Deviation|Mean
2600839|NCT02158494|Other Pre-specified|Change in Dynamic Gait Index (DGI) Over Baseline|Assesses walking, walking with head turns, over and around obstacles, and stairs. Dynamic Gait Index - A semiquantitative tool used to evaluate a patient's ability to modify gait by changing task demands, esp. in patients with dizziness and balance deficits. This test is used to identify patients, esp. older adults, who are predisposed to falling. Participants are graded from 0 (low function) to 3 (high function) on 8 tasks: normal walking, their ability to vary walking speed, turn their heads, turn their bodies, step over and around obstacles, climb stairs, turn while walking. The range of scores is 0-24, higher scores indicate higher function, with a score of 24 considered Normal. Change from baseline to 2, 14, and 26 weeks is reported.|Change from Baseline at 2,14, and 26 weeks||||score on a scale||Standard Deviation|Mean
2600840|NCT02158494|Other Pre-specified|Change in 6-Minute Walk Test (6MWT) Over Baseline|Measures walking speed over ground. The six-minute walk test (6MWT) measures the distance in meters an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. Change in 6MWT over baseline for each time point is reported.|Change from Baseline at 2,14, and 26 weeks||||meters||Standard Deviation|Mean
2600841|NCT02158494|Other Pre-specified|Change in Neurobehavioral Symptom Inventory Over Baseline|A 22-item subjective inventory of TBI symptoms where symptoms are scored on a scale of 0 (none) to 4 (very severe). Lower scores indicate decreased symptoms. Group mean change from baseline at 2, 14, and 26 weeks is reported. The range of possible scores if from 0 to 88. The results are reported as a change from baseline.|Change from Baseline at 2,14, and 26 weeks||||score on a scale||Standard Deviation|Mean
2600842|NCT02158494|Primary|NeuroCom Computerized Dynamic Posturography Sensory Organization Test (SOT)|"SOT assesses the ability to use visual, proprioceptive, and vestibular cues to maintain postural stability. Subjects stand on dual-force plates and the anterior-posterior sway is recorded. 6 conditions are tested (3, 20-sec trials each): Eyes open on firm surface; Eyes closed on firm surface; Eyes open with sway referenced visual surround; Eyes open on sway referenced support surface; Eyes closed on sway referenced support surface; Eyes open on sway referenced support surface and surround.~A composite score is generated by the NeuroCom BalanceMaster System using an algorithm to calculate the composite score from each of the 3 serial repetitions for each of the 6 conditions (a total of 18 sub-scores). The calculated composite score ranges from 0 to 100 points; 0 is complete failure, 100 is perfect stability, 70 is the lower limit normal. Group mean score for each time-point is reported."|Baseline, 2, 14, and 26 weeks||||score on a scale||Standard Deviation|Mean
2600843|NCT02158442|Primary|Efficacy of Timentin Delivered by PILP Procedure (Treatment Group) Versus Intravenous Delivery (Control Group) at Reducing Microbiological Load in Subjects With Diabetes, and Significant Wound Infection of the Lower Limb.|Reduction in microbiological load, including assessment of CFU, infection type and antibiotic sensitivity between the two groups over time. To compare the efficacy of Timentin delivered by PILP procedure (Treatment Group) versus intravenous delivery (Control Group) at reducing microbiological load in subjects with diabetes, and significant wound infection of the lower limb.|Day 3|"Treatment Group: 5 of the 5 analyzable microbiological loads resulted in a reduction. 1 was not analyzable.~Control Group: 3 of the 3 analyzable microbiological loads resulted in a reduction. 4 were not analyzable."|||participants|||Number
2600844|NCT02158364|Secondary|Number of Participants With Adverse Drug Reactions (ADRs)|ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Up to Day 28|"Vaccinated Safety Analysis Set included all participants who received measles/rubella combined vaccine Takeda as the second vaccination. Here number of participants analyzed are participants evaluable for this outcome measure."|||Participants|||Count of Participants
2600845|NCT02158364|Primary|Number of Participants With Serious Adverse Drug Reactions (ADRs)|Serious ADRs are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Frequency of adverse events and factors that may influence safety were not to be assessed as endpoints of this study and were registered as endpoints by mistake. Instead, ADRs were assessed as endpoint.|Up to Day 28|"Vaccinated Safety Analysis Set included all participants who received measles/rubella combined vaccine Takeda as the second vaccination. Here number of participants analyzed are participants evaluable for this outcome measure."|||Participants|||Count of Participants
2600846|NCT02158273|Secondary|Change From Baseline in Standard Drinks Per Week at 1 Week|Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 1 - Baseline). More negative values indicate less use of alcohol.|1 week||||drinks/week||Standard Deviation|Mean
2600886|NCT02157883|Secondary|AUC(0-t) of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration curve from time zero to last quantifiable dose|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).|||nM*h||Full Range|Geometric Mean
2600847|NCT02158273|Primary|Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period|The four Visual Analog Scale (VAS) questions assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity. Each VAS scale item score ranges from 1-20 where a one indicates no craving and 20 indicates severe craving; thus, a higher score indicates a worse outcome. Total is a summation of the four VAS item scores (i.e. Intent, Impulse, Relief, Strength) and ranges in value from 4-80 with higher scores indicative of a worse outcome.|1 week following administration of fenofibrate||||units on a scale||Standard Deviation|Mean
2600848|NCT02158247|Primary|Airway Length vs Height in Female||Endotracheal intubation time||||Centimeters||Standard Deviation|Mean
2600849|NCT02158247|Primary|Airway Length vs Height in Male||Endotracheal intubation time||||Centimeters||Standard Deviation|Mean
2600850|NCT02158247|Secondary|Comparison Between Conventional Method and Touch and Read Method for Normal Group of Female|"Normal group is defined as the patients whose airway length from medial incisor to carina is over 23cm.~Conventional method : depth of intubation is 21cm at the medial incisor for female.~Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 11.5cm for female."|Endotracheal intubation time||||Centimeters||Standard Deviation|Mean
2600851|NCT02158247|Secondary|Comparison Between Conventional Method and Touch and Read Method for Risk Group of Female|"Risk group is defined as the patients whose airway length from medial incisor to carina is below 23cm.~Conventional method : depth of intubation is 21cm at the medial incisor for female.~Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 11.5cm for female."|Endotracheal intubation time||||Centimeters||Standard Deviation|Mean
2600852|NCT02158247|Secondary|Comparison Between Conventional Method and Touch and Read Method for Normal Group of Male|"Normal group is defined as the patients whose airway length from medial incisor to carina is over 25cm.~Conventional method : depth of intubation is 23cm at the medial incisor for male.~Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 12.5cm for male."|Endotracheal intubation time||||Centimeters||Standard Deviation|Mean
2600853|NCT02158247|Secondary|Comparison Between Conventional Method and Touch and Read Method for Risk Group of Male|"Normal group is defined as the patients whose airway length from medial incisor to carina is below 25cm.~Conventional method : depth of intubation is 23cm at the medial incisor for male.~Touch and read method : depth of intubation is calculated as follow : length from mouth angle to epiglottis tip plus 12.5cm for male."|Endotracheal intubation time||||Centimeters||Standard Deviation|Mean
2600854|NCT02158247|Primary|Comparison of Airway Length Between Male and Female|Airway length is defined the distance from medial incisor to carina. It is divided into four parts. It is medial incisor to mouth angle, mouth angle to epiglottis tip, epiglottis tip to vocal cords and vocal cords to carina.|Endotracheal intubation time||||Centimeters||Standard Deviation|Mean
2600855|NCT02158091|Secondary|Duration of Remission Rate|Response and progression will be evaluated in this study using the 2008 IW-CLL criteria for CLL (Hallek et al., 2008)Frequency of follow up visits and scans are per MD discretion. Recommended follow up visits for a minimum of one year|At baseline, End of Cycle 3, and 2 months post FCR and then per investigator discretion thereafter||2020-11-30|11/2020||||
2600856|NCT02158091|Secondary|Event Free Survival Rate|Response and progression will be evaluated in this study using the 2008 IW-CLL criteria for CLL (Hallek et al., 2008)|At baseline, End of Cycle 3, and 2 months post FCR and then per investigator discretion thereafter||2020-11-30|11/2020||||
2600857|NCT02158091|Secondary|Rate of Progression Free Survival|2008 IW-CLL criteria|At baseline, End of Cycle 3, and 2 months post FCR and then per investigator discretion thereafter||2020-11-30|11/2020||||
2600858|NCT02158091|Secondary|Rate of Complete Response and Partial Response|Response and progression will be evaluated in this study using the 2008 IW-CLL criteria for CLL (Hallek et al., 2008)|At baseline, End of Cycle 3, and 2 months post FCR and then per investigator discretion thereafter||2020-11-30|11/2020||||
2600859|NCT02158091|Secondary|Determine the Association of Established CLL Prognostic Factors With Clinical Response|Fisher's exact test for categorical variables and Wilcoxon's rank sum test will be used-|2 Years|||||||
2600860|NCT02158091|Secondary|Rate of Treatment Related Adverse Effects|Participants will be evaluable for this endpoint if they have had at least 1 dose of study treatment. Toxicities will be assessed at minimum each week during cycle 1, and each day 1 during combination therapy, and then every two months thereafter. CTCAE version 4.0 will be used to assess toxicity term and grading.|210 days|||||||
2600861|NCT02158091|Secondary|Rate of Minimal Residual Disease (MRD) in the Peripheral Blood|Participants will have MRD testing in the peripheral blood by four-color flow cytometry at the end of cycle 3, 2 months post combination therapy, and every 6 months thereafter for the duration of treatment and subsequent follow up|2 Years|||||||
2600862|NCT02158091|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Toxicity assessments will be done using the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) and will include all participants who have received at least 1 dose of IPI-145. Toxicities will be assessed at minimum every week during cycle 1, on Day 1 of every cycle during Cycle 2 onward, and every other cycle Day 1 during maintenance.|Up to 210 days|||||||
2600863|NCT02158091|Secondary|Overall Response Rate|Response and progression will be evaluated in this study using the 2008 IW-CLL criteria for CLL (Hallek et al., 2008)|At baseline, End of Cycle 3, and 2 months post FCR||2020-11-30|11/2020||||
2600864|NCT02158091|Primary|Number of Patients Who Had a Minimal Residual Disease (MRD) Negative Complete Response (CR) 2 Months After Chemotherapy|To determine the rate of minimal residual disease negative complete response (MRD negative CR) in the bone marrow at 2 months post last cycle of FCR, participants will have a bone marrow biopsy procedure 2 months after completing combination therapy (IPI-145+ FCR) in tandem with a chest,neck, abdomen and pelvic PET CT scan. A central read of the PET CT scan will confirm a radiographic complete response, and the bone marrow pathology and morphology assessments will confirm morphological CR in the bone marrow, while MRD testing will be done by four-color flow cytometry on the bone marrow aspirate with a detection level of 10-4. This will include all patients treated and evaluable at maximum tolerated dose, and at the recommended phase II dose ( RP2D)|2 months after completion of combination therapy of IPI-145 and FCR||||Percentage of participants||95% Confidence Interval|Number
2600865|NCT02158091|Primary|Number of Patients Who Experienced a Dose Limiting Toxicity (DLT) During Phase I|To assess the safety of IPI145 in combination with FCR in previously untreated younger patients with CLL. DLT is based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. DLT refers to toxicities experienced at any time during the study treatment, defined as Grade 3 or greater hematologic toxicity (except Grade 3 or Grade 4 neutropenia or thrombocytopenia that lasts less than or equal to 10 days off treatment), any Grade 3 or greater non-hematologic toxicity (except Grade 3 or greater nausea, vomiting, diarrhea, Grade 3 infusion reactions), Grade 3 asymptomatic laboratory abnormalities that improve to grade 2 or less within 3 days, Inability to receive day 1 therapy of Cycle 2 even after a three week treatment delay due to drug related toxicity from prior cycle, and any Grade 4 or greater elevation in AST ALT values|. Participants were assessed every week or more often as needed during Cycle 1, and every Day 1 Cycles 2 and onward-Dose-limiting toxicities (DLTs) occurring during the first cycle of treatment will be used in determining the Phase II MTD/RP2D|Patients who have received no prior therapy for CLL but who meet IW-CLL 2008 Criteria for requiring treatment|||Participants|||Count of Participants
2600866|NCT02158039|Primary|Number of Subjects With Complete or Partial Ablation of the Treated Cyst|Complete or partial ablation of cysts will be defined by the presence of a persistent cystic structure, and its volume and maximum diameter, as determined by cross-sectional imaging studies (CT, MR)|1 year after final treatment||||participants|||Number
2600867|NCT02158039|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Adverse events include pancreatitis, bleeding, perforation, any other occurrence resulting in hospitalization, medical treatment, surgery, death, or disability|1 year after final treatment||||participants|||Number
2600868|NCT02157948|Secondary|Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)||Baseline, month 1, month 6 and month 12|"The bone turnover marker (BTM) efficacy analysis subset includes all randomized participants who had a baseline measurement and at least one post baseline measurement. n indicates the number of participants with available data at each time point."|||percent change||Inter-Quartile Range|Median
2600869|NCT02157948|Secondary|Percent Change From Baseline in Serum Type I Collagen C-telopeptide (sCTX)||Baseline, month 1, month 6 and month 12|"The bone turnover marker (BTM) efficacy analysis subset includes all randomized participants who had a baseline measurement and at least one post baseline measurement. n indicates the number of participants with available data at each time point."|||percent change||Inter-Quartile Range|Median
2600870|NCT02157948|Primary|Percent Change From Baseline in Lumbar Spine BMD|Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and Month 12|The primary efficacy analysis subset included all randomized participants who had a baseline lumbar spine DXA BMD measurement and at least 1 postbaseline lumbar spine DXA BMD measurement. Postbaseline BMD values obtained at the early termination visit were carried forward as the month-12 value.|||percent change||Standard Deviation|Mean
2600871|NCT02157935|Secondary|Nights With Awakening Due to COPD|"Nighttime awakening due to COPD symptoms correspond to the severity of nocturnal symptoms from COPD.~The average number of awakening per night over the treatment period was analyzed. It was derived as the number of night with awakening divided by the total number of nights with data in the recording period. Change from baseline period on awakening was summarized and compared between two arms using a mixed model."|From Run-in W -4 to EoT W 26|The change from baseline on awakening were analyzed on randomized patients with a baseline and a post-baseline value. Among 1219 patients who were randomized, only 603 patients in Symbicort group and 610 patients in Formoterol group had valid data and included in analysis.|||awakening/night||Standard Deviation|Mean
2600872|NCT02157935|Secondary|Total Rescue Medication Use (Average Puffs/Day)|"Use of rescue medication is a measure of symptoms that need to be treated with a short-acting bronchodilator.~The average daily use across the observation period was used for analysis. Change from baseline was summarized and compared between two arms using a mixed model."|From Run-in W -4 to EoT W 26|The change from baseline on rescue medication use were analyzed on randomized patients with a baseline and a post-baseline value. Among 1219 patients who were randomized, only 602 patients in Symbicort group and 607 patients in Formoterol group had valid data and included in analysis.|||puffs/day||Standard Deviation|Mean
2600873|NCT02157935|Secondary|Pre-dose/Pre-bronchodilator FEV1 at the Study Site|FEV1 from pre-dose spirometry is a measurement of lung function. The change from baseline on pre-dose FEV1 was summarized and compared between Symbicort and Formoterol groups using a mixed model.|From Run-in W -4 to EoT W 26|The change from baseline in pre-dose FEV1 were analyzed on randomized patients with a baseline pre-dose FEV1 and at least one post-baseline value. Among 1219 patients who were randomized, only 588 patients in Symbicort group and 589 patients in Formoterol group had valid data and included in analysis.|||L||Standard Deviation|Mean
2600874|NCT02157935|Secondary|St. George's Respiratory Questionnaire (SGRQ)|"SGRQ is a standardized, self-administered tool for measuring impaired health and perceived wellbeing in respiratory diseases; a validated electronic version of the questionnaire in the relevant validated languages was used in this study.~The questionnaire contains 50 items divided into three dimensions (Symptoms, Activity and Impact).~Each of the three dimensions of the questionnaire is scored separately in the range from 0 to 100:~zero (0) score indicating no impairment of quality of life.~The total SGRQ score ranging from 0 to 100 is a summary score utilizing responses to all items calculated using weights attached to each item of the questionnaire.~Higher scores indicate poorer health and change of 4 units in the SGRQ has been determined to be the threshold for a clinically relevant change in health status.~The change from baseline was statistically summarized and compared between two arms in a mixed model."|From Run-in W -4 to EoT W 26|The change from baseline in SGRQ were analyzed on randomized patients with a baseline SGRQ and at least one post-baseline value. Among 1219 patients who were randomized, only 589 patients in Symbicort group and 593 patients in Formoterol group had valid data and included in analysis.|||scores on a scale||Standard Deviation|Mean
2600875|NCT02157935|Secondary|Number of Patients With Moderate or Severe COPD Exacerbation.|"The number of patients who developed moderate or severe COPD exacerbation during treatment period were reported. Cox proportional hazards regression model was fitted to data to compare the two treatment arms .~The hazard ratio and 95% CI were estimated."|From randomzation to EoT W 26||||Participants|||Number
2620693|NCT01953328|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2600876|NCT02157935|Primary|The Rate of Moderate and Severe COPD Exacerbations Defined as: Worsening of ≥2 Major Symptoms or Worsening of 1 Major Symptom Together With ≥1 Minor Symptom for ≥2 Consecutive Days|"The annual COPD exacerbation rate was analyzed and compared between two arms.~Annual exacerbation rate for each subject is defined as number of exacerbations divided by duration of randomized treatment period in years.~The annual COPD exacerbation rate of Symbicort group was compared with annual rate of Formoterol group. The rate ratio of Symbicort vs. Formoteroal was assessed by a negative binomial model.~Exacerbations, that met the modified Anthonisen criteria and duration ≥2 days were classified as moderate and severe exacerbations.~Moderate exacerbation: treatment of symptoms with systemic corticosteroids (≥3 days) and/or antibiotics.~Severe exacerbation: symptoms that require hospitalization (including >24 hours in ED/urgent care setting)."|Randomization at Week 0 to End of Treatment (EoT) W 26|Full analysis set including all randomized subjects|||COPD exacerbations per year||95% Confidence Interval|Least Squares Mean
2600877|NCT02157909|Primary|Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes|"With the contact lens on eye, the investigator assessed the lens fit immediately post-blink and following lower lid margin push-up with the lower lid using a 5-point scale, where -2 = Unacceptably tight (reduced movement, unacceptable), -1 = Acceptably tight (reduced movement, acceptable), 0 = Optimal fit / movement, +1 = Acceptably loose (excessive movement, acceptable), and +2 = Unacceptably loose (excessive movement, unacceptable). To meet the definition of no re-fit, an eye had to have an acceptable or optimal overall lens fit with the study lens, as well as be within 1 grade of the overall lens fit assessed with the habitual lens at baseline. Proportion of subjects is reported as a percentage."|Dispense (Day 0), Week 1|This analysis population includes all randomized and treated subjects.|||percentage of subjects|||Number
2600878|NCT02157883|Secondary|AUC of AZ7550|Pharmacokinetics of AZ7550 (metabolite to AZD9291) by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations, where AUC possible to calculate, and including Period 2 data (all patients met carry over criteria of Period 2 pre-dose AZ7550 concentration >20% of Cmax).|||nM*h||Full Range|Geometric Mean
2600879|NCT02157883|Secondary|Cmax of AZ7550|Pharmacokinetics of AZ7550 (metabolite to AZD9291) by assessment of maximum plasma AZ7550 concentration|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and including Period 2 data (since all patients met carry over criteria of Period 2 pre-dose AZ7550 concentration >20% of Cmax).|||nM||Full Range|Geometric Mean
2600880|NCT02157883|Secondary|AUC of AZ5104|Pharmacokinetics of AZ5104 (metabolite to AZD9291) by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose AZ5104 concentration >20% of Cmax).|||nM*h||Full Range|Geometric Mean
2600881|NCT02157883|Secondary|Cmax of AZ5104|Pharmacokinetics of AZ5104 (metabolite to AZD9291) by assessment of maximum plasma AZ5104 concentration|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose AZ5104 concentration >20% of Cmax).|||nM||Full Range|Geometric Mean
2600882|NCT02157883|Secondary|Vz/F of AZD9291|Rate and extent of absorption of AZD9291 by assessment of the apprarent volume of distribution|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).|||L||Full Range|Geometric Mean
2600883|NCT02157883|Secondary|CL/F of AZD9291|Rate and extent of absorption of AZD9291 by assessment of apparent clearance following oral administration|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).|||L/h||Full Range|Geometric Mean
2600884|NCT02157883|Secondary|t1/2 of AZD9291|Pharmacokinetics of AZD9291 by assessment of the terminal half-life|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).|||hours||Full Range|Geometric Mean
2600885|NCT02157883|Secondary|Tmax of AZD9291|Pharmacokinetics of AZD9291 by assessment of time to Cmax|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).|||hours||Full Range|Median
2601026|NCT02155985|Secondary|Change in Serum Thromboxane B2 From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||fold change||95% Confidence Interval|Mean
2600887|NCT02157883|Secondary|AUC(0-120) of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to 120 hours|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).|||nM*h||Full Range|Geometric Mean
2600888|NCT02157883|Primary|AUC of AZD9291|Pharmacokinetics of AZD9291 by assessment of area under the plasma concentration time curve from zero to infinity|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).|||nM*h||Full Range|Geometric Mean
2600889|NCT02157883|Primary|Cmax of AZD9291|Pharmacokinetics of AZD9291 by assessment of maximum plasma AZD9291 concentration|Blood samples collected on Day 1 and Day 10 at pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 168, and 216 hours post AZD9291 dose in Part A.|All patients who received at least 1 dose of AZD9291 and had sufficient postdose PK assessments to determine outcome measure without important protocol deviations/violations and excluding Period 2 data for patients meeting carry-over exclusion criterion (defined as Period 2 pre-dose concentration >10% of Cmax).|||nM||Full Range|Geometric Mean
2600890|NCT02157779|Post-Hoc|Overt Aggression Scale-Modified (OAS-M) - Aggressive Outbursts|Structured Interview that assesses verbal and physical aggressive behaviors. Minimum and Maximum Values range from 0 to no maximum, higher scores means more anger.|Baseline, Weeks 4, 8,12, 3 and 6 months post-treatment|Participants were randomly assigned to the Cognitive Behavioral Intervention or the Supportive Intervention). Participants with at least one post-baseline measure (i.e. one or more of 4wk, 8wk, end of treatment, 3 mo f/u, 6 mo f/u) were included in HLM analysis. Mean scores and SDs are shown for all participants with data at each assessment point.|||score on a scale||Standard Deviation|Mean
2600891|NCT02157779|Post-Hoc|Dimensions of Anger Response (DAR)|The DAR is a 7 item self-report measure of anger reactions. It has been found to be reliable and sensitive to change. Higher scores reflect more severe anger. Scores can range from 0 to 28.|Weekly||2020-09-30|09/2020||||
2600892|NCT02157779|Post-Hoc|Overt Aggression Scale-Modified (OAS-M) - Irritability Scale|Structured Interview that assesses verbal and physical aggressive behaviors. Minimum and Maximum Values range from 0 to 10, higher scores means more anger.|Baseline, Weeks 4, 8,12, 3 and 6 months post-treatment|Participants were randomly assigned to the CBI or SI using Wei and Stout's urn randomization. Participants with at least one post-baseline measure (i.e. one or more of 4wk, 8wk, end of treatment, 3 mo f/u, 6 mo f/u) were included in HLM analysis. Mean scores and SDs are shown for all participants with data at each assessment point.|||score on a scale||Standard Deviation|Mean
2600893|NCT02157779|Other Pre-specified|Change From Baseline in Anger on the Anger Consequences Questionnaire (ACQ)Total Score|The ACQ is a brief self-report measure developed to assess the frequency of negative anger-related behavioral consequences. Internal consistencies of .75 to .91 were reported on the original 42 item version; the revised version shortened the measure to 33 items based on factor analysis. This scale includes items not covered by the other anger measures, including for example, trouble with the law, driving recklessly, getting into an accident, damaging relationships, etc. Minimum and Maximum Values range from 0 to 200, higher scores means more anger.|Baseline, Week 12, 3 and 6 months Post-treatment|||||||
2600894|NCT02157779|Secondary|Change From Baseline in PTSD Symptoms on the Clinician-Administered PTSD Scale (CAPS) for DSM-5 Total Score|The CAPS-5 (updated for DSM-5) is a clinician administered structured interview for the assessment of DSM-5 PTSD. The CAPS has excellent reliability and validity and is widely used in PTSD treatment research. Each one of the DSM-5 PTSD symptoms is rated on a 0-4 (low to high) scale to determine symptom severity. The cutoff used to establish the presence of an individual symptom is a score of 2 or greater. Overall PTSD severity is computed by summing the totals for all items. Minimum and Maximum Values range from 0 to 80, higher scores mean higher levels of symptomatology.|Baseline,12 weeks, 3 and 6 months post-treatment|Participants were randomly assigned to CBI or SI. Participants with at least one post-baseline measure (end of treatment, 3 mo f/u, and/or 6 mo f/u) were included in HLM analysis. 28 participants (20 CBI, 10 SI) did not have post-baseline data on this scale. Mean scores / SDs are shown for all participants with data at each time point.|||score on a scale||Standard Deviation|Mean
2600895|NCT02157779|Secondary|Change From Baseline in Quality of Life From WHO Quality of Life (WHOQOL) - Psychological|The World Health Organization Quality of Life (WHOQOL-BREF), is 26 item self-report measure used to assess quality of life in multiple domains (i.e., physical, psychological, social, and environment). Psychometric properties suggest that the measure is valid and reliable across cultures and nations. Minimum and Maximum Values range from 6 to 30, higher scores mean better quality of life.|Baseline, 12 weeks, 3 and 6 months post-treatment|Participants were randomly assigned to CBI or SI. Participants with at least one post-baseline measure (end of treatment, 3 mo f/u, and/or 6 mo f/u) were included in HLM analysis. 32 participants (22 CBI, 10 SI) did not have post-baseline data on this scale. Mean scores / SDs are shown for all participants with data at each time point.|||units on a scale||Standard Deviation|Mean
2600896|NCT02157779|Secondary|Change From Baseline in Interpersonal and Social Functioning on the Outcomes Questionnaire (OQ)-Total Score|The OQ is a self report measure that assesses functioning and includes three subscales: symptom distress, interpersonal relations, and social role functioning. Concurrent validity has been demonstrated in relation to internal consistency and reliability. Additionally, the OQ has been shown to be fairly stable in untreated individuals and sensitive to change in those individuals in treatment. Minimum and Maximum Values range from 0 to 180, higher scores mean worse functioning.|Baseline, 12 weeks, 3 and 6 months post-treatment|Participants were randomly assigned to CBI or SI. Participants with at least one post-baseline measure (end of treatment, 3 mo f/u, and/or 6 mo f/u) were included in HLM analysis. 29 participants (21 CBI, 8 SI) did not have post-baseline data on this scale. Mean scores / SDs are shown for all participants with data at each time point.|||score on a scale||Standard Deviation|Mean
2620694|NCT01953328|Secondary|Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2600897|NCT02157779|Secondary|Change From Baseline in Work Functioning on the Longitudinal Interval Follow-up Evaluation (LIFE) Global Employment Score|Psychosocial functioning scales from the clinician administered Longitudinal Interval Follow-up Evaluation (LIFE) provides assessment of functioning in areas of work (employment, household, or student), familial and nonfamilial interpersonal relationships, recreation, and global social adjustment on separate 6 to 8-point scales. Ratings will be based on the past month. The psychosocial functioning ratings have been found to be of generally high reliability. Minimum and Maximum Values range from 1 to 5, higher scores mean worse functioning.|Baseline, 12 weeks, 3 and 6 months post-treatment|Participants were randomly assigned to CBI or SI. Participants with at least one post-baseline measure (4wk, 8wk, end of treatment, 3 mo f/u, and/or 6 mo f/u) were included in HLM analysis. 28 participants (20 CBI, 8 SI) did not have post-baseline data on this scale. Mean scores / SDs are shown for all participants with data at each time point.|||units on a scale||Standard Deviation|Mean
2600898|NCT02157779|Secondary|Change From Baseline in Social Functioning on the Longitudinal Interval Follow-up Evaluation (LIFE) Global Social Score|Psychosocial functioning scales from the clinician administered Longitudinal Interval Follow-up Evaluation (LIFE) provides assessment of functioning in areas of work (employment, household, or student), familial and nonfamilial interpersonal relationships, recreation, and global social adjustment on separate 6 to 8-point scales. Ratings will be based on the past month. The psychosocial functioning ratings have been found to be of generally high reliability. Minimum and Maximum Values range from 1 to 5, higher scores mean worse functioning.|Baseline, 12 weeks, 3 and 6 months post-treatment|Participants were randomly assigned to CBI or SI using Wei and Stout's urn randomization strategy. Participants with at least one post-baseline measure (i.e. one or more of end of treatment, 3 mo f/u, 6 mo f/u scores) were included in HLM analysis. Mean scores and SDs are shown for all participants with data at each assessment point.|||units on a scale||Standard Deviation|Mean
2600899|NCT02157779|Primary|Overt Aggression Scale-Modified (OAS-M) - Aggression Scale Score|Structured Interview that assesses verbal and physical aggressive behaviors. Minimum and Maximum Values range from 0 to no maximum, higher scores mean more anger.|Baseline, Weeks 4, 8,12, 3 and 6 months post-treatment|Participants were randomly assigned to CBI or SI. Participants with at least one post-baseline measure (4wk, 8wk, end of treatment, 3 mo f/u, and/or 6 mo f/u) were included in HLM analysis. 25 participants (13 CBI, 6 SI) did not have post-baseline data on this scale. Mean scores / SDs are shown for all participants with data at each time point.|||score on a scale||Standard Deviation|Mean
2600900|NCT02157779|Primary|Change From Baseline in Anger on the State Trait Anger Inventory 2 (STAXI-2) - Anger Expression Index Score|The STAXI-2 is a revision of Spielberger's State-Trait Anger Expression Inventory (STAXI), expanded from 44 to 57 items. It is a self-report questionnaire consisting of six scales and an Anger Expression Index (AX). Scales include State Anger, Trait Anger, Anger Expression-Out, Anger Expression-In, Anger Control-Out and Anger Expression-In. The Anger Expression Index is an overall measure of the expression and control of anger based on responses to the two anger expression and the two anger control subscales.Minimum and Maximum Values range from 0 to 96, higher scores mean more anger.|Baseline, Weeks 4, 8,12, 3 and 6 months post-treatment|Participants were randomly assigned to CBI or SI. Participants with at least one post-baseline measure (4wk, 8wk, end of treatment, 3 mo f/u, and/or 6 mo f/u) were included in HLM analysis. 25 participants (15 CBI, 10 SI) did not have post-baseline data on this scale. Mean scores / SDs are shown for all participants with data at each time point.|||score on a scale||Standard Deviation|Mean
2600901|NCT02157623|Secondary|Patient Satisfaction Survey|Overall patient satisfaction with the technique will be assessed using a simple survey.|6 months|||||||
2600902|NCT02157623|Secondary|Pain Score on a Visual-Analog Scale|Tolerability, defined as pain during treatment using Red light versus Blue light PDT, will be assessed.|6 months|||||||
2600903|NCT02157623|Primary|Tumor Clearance Rate|The rate of clearance of existing BCC tumors will be assessed in patients with BCNS, using clinical and photographic measurements. The endpoint will be assessed for tumors in a Red light treatment field and a Blue light treatment field in each patient, and compared.|6 months|study terminated, no outcomes||||||
2600904|NCT02157519|Secondary|Hospitalizations|"Description: Resource Utilization Questionnaire, an adapted 3-item questionnaire inquiring about the number of emergency department visits and hospitalizations over the past three months (self-report). Patients are asked to indicate how many times they have been admitted to the hospital in the past three months on a numerical scale ranging from 0 to 5 or more. Scores ranged from 0-5. A higher score represents more frequent hospital admissions, indicating higher resource utilization."|Post-Assessment (12-14 weeks after baseline)|Analysis population is the number of participants who completed both baseline and post-assessment measures of the Resource Utilization Questionnaire (RUQ) and the Multidimensional Scale of Perceived Social Support (MSPSS).|||Scores on a scale||Standard Deviation|Mean
2600905|NCT02157519|Secondary|Emergency Department Visits|"Resource Utilization Questionnaire, an adapted 3-item questionnaire inquiring about the number of emergency department visits and hospitalizations over the past three months (self-report). Patients are asked to indicate how many times they have gone to the emergency room in the past three months on a numerical scale ranging from 0 to 5 or more. Scores ranged from 0-5. A higher score represents more frequent emergency department visits, indicating higher resource utilization."|Post-Assessment (12-14 weeks after baseline)|Analysis population is the number of participants who completed both baseline and post-assessment measures of the Resource Utilization Questionnaire (RUQ) and the Multidimensional Scale of Perceived Social Support (MSPSS)|||Scores on a scale||Standard Deviation|Mean
2600914|NCT02157506|Secondary|Mean Time-Averaged Change From Baseline in Mean Arterial Blood Pressure (MAP) During the Infusion|Mean arterial pressure during infusion of CXL-1427 or placebo on a modified intent-to-treat population is presented|Baseline, Hour 24 after infusion, Follow-up visit 1|Modified Intent-To-Treat Analysis Set: all randomized participants who received all or part of the infusion of the study drug and had at least one baseline and post-baseline invasive hemodynamic assessment.|||mm Hg||Standard Deviation|Mean
2600915|NCT02157506|Secondary|Mean Time-Averaged Change From Baseline in Adjudicated Right Atrial Pressure (RAP) During the Infusion|The effects of CXL-1427 on time-averaged RAP during the course of the infusion are presented|Baseline, Hour 2, Hour 4, Hour 6, Hour 8 post infusion initiation|Modified Intent-To-Treat Analysis Set: all randomized participants who received all or part of the infusion of the study drug and had at least one baseline and post-baseline invasive hemodynamic assessment.|||mm Hg||Standard Deviation|Mean
2600906|NCT02157519|Secondary|Treatment Satisfaction|Description: Functional Assessment of Chronic Illness Treatment-Treatment Satisfaction-Patient Satisfaction (FACIT-TS-PS), 21-items that assesses patient satisfaction with doctor and staff competence, communication, and confidence and trust in providers, as well as overall satisfaction of care (self-report). The FACIT-TS-PS uses a 0-3 numerical rating scale to assess satisfaction with healthcare, with 0 representing the lowest level of satisfaction and 3 representing the highest level of satisfaction. Four subscales are computed by taking the sum: explanations (4 items; range 0-12), interpersonal (3 items, range 0-9), comprehensive care (7 items; range 0-21), nurses (3 items; range 0-9), and trust (4 items; range 0-12). A higher score indicates greater satisfaction with care, while a lower score represents lower satisfaction with care.|Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)|Analysis population is the number of participants who completed both baseline and post-assessment measures of the FACIT-TS-PS and the Multidimensional Scale of Perceived Social Support (MSPSS)|||units on FACIT-TS-PS scale||Standard Deviation|Mean
2600907|NCT02157519|Primary|Change in Quality of Life|Functional Assessment of Cancer Treatment - General (FACT-G): a 27-item questionnaire that assesses physical, social, emotional, and functional well-being (self-report). The FACT-G utilizes a five-point scale from 0 (not at all) to 4 (very much). Four subscales are computed by taking the sum: physical well-being (7 items; range 0-28), social/family well-being (7 items; range 0-28), emotional well-being (7 items; range 0-24), and functional well-being (7 items; range 0-28). The overall score is the sum of the four subscale scores (range 0-108). Higher scores indicate greater quality of life, while lower scores indicate a worse quality of life.|Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)|Analysis population is the number of participants who completed both baseline and post-assessment measures of the FACT-General (FACT-G) and the Multidimensional Scale of Perceived Social Support (MSPSS)|||units on the FACT-G scale||Standard Error|Mean
2600908|NCT02157519|Primary|Change in Symptoms and Side Effects|"M.D. Anderson Symptom Inventory (MDASI): a 19-item instrument that assesses the most common symptoms and side effects related to cancer and its treatment (self-report). The MDASI uses a 0-10 numerical rating scale for all items to assess the severity and interference of symptoms patients have experienced in the past 24 hours, with 0 being not present or did not interfere and 10 being as bad as you can imagine or interfered completely. The ratings in the MDASI are averaged into two subscale scores: mean symptom severity (13 symptom items) and mean interference (6 interference items only), with possible scores on both subscales ranging from 0-10. Higher scores indicate worse symptom severity and interference, while lower scores indicate less symptom severity and interference."|Change score between 1) Baseline (within 2 weeks after enrollment) and 2) Post-Assessment (12-14 weeks after baseline)|Participants who completed both baseline and post measures of the MDASI and the Multidimensional Scale of Perceived Social Support (MSPSS). Due to a clerical error, the MDASI was not administered to 31 pts at baseline. One pt skipped the symptom interference scale, causing a discrepancy in the number of pts completing each subscale on the MDASI.|||units on MDASI scale||Standard Error|Mean
2600909|NCT02157519|Primary|Adherence to Oral Chemotherapy Medication|Medication Event Monitoring System (MEMS) utilizes an electronic pill cap to record the date and time the pill dispenser was opened.|Daily over course of study from baseline (within 2 weeks after enrollment) to post assessment (12-14 weeks after baseline)|Analysis population is the number of participants who had data available from the Medication Event Monitoring System (MEMS) and completed the Multidimensional Scale of Perceived Social Support (MSPSS) at both the baseline and post assessments.|||percentage of medication taken||Standard Deviation|Mean
2600910|NCT02157519|Primary|Self-reported Difficulties With Adherence on Any of the Four MMAS-4 Items in the Past Week|"The Morisky Medication Adherence Questionnaire (MMAS-4) - a 4-item questionnaire that assesses medication adherence in the past week by asking patients to indicate yes or no to each item (self-report). The four items ask patients to self-report whether they forgot to take their oral chemotherapy (OC) medication in the past week, whether they had any problems remembering to take their OC medication in the last week, whether they stopped taking their OC medication when they felt better in the past week, and whether they stopped taking their OC medication when they felt worse in the past week. Participants who answered yes to any of the four items were coded as having adherence problems, while those who indicated no to all four items were coded as having no adherence problems. Therefore, the count of participants is the number of participants who reported any difficulties with adherence on any of the four items in the past week."|Post-Assessment (12-14 weeks after baseline) controlling for baseline assessment|Analysis population is the number of participants who completed the post-assessment measure of the MMAS-4|||Participants|||Count of Participants
2600911|NCT02157506|Secondary|Mean Time-Averaged Change From Baseline in Heart Rate (HR) During the Infusion|Mean Time-Averaged Change from Baseline in Heart Rate during infusion of CXL-1427 or placebo on a modified intent-to-treat population is presented|Baseline, Hour 24 after infusion, Follow-up visit 1|Modified Intent-To-Treat Analysis Set: all randomized participants who received all or part of the infusion of the study drug and had at least one baseline and post-baseline invasive hemodynamic assessment.|||Beats/min||Standard Deviation|Mean
2600912|NCT02157506|Secondary|Mean Time-Averaged Change From Baseline in Diastolic Blood Pressure (DBP) During the Infusion|Mean Time-Averaged Change from Baseline in Diastolic Blood Pressure during infusion of CXL-1427 or placebo on a modified intent-to-treat population is presented|Baseline, Hour 24 after infusion, Follow-up visit 1|Modified Intent-To-Treat Analysis Set: all randomized participants who received all or part of the infusion of the study drug and had at least one baseline and post-baseline invasive hemodynamic assessment.|||mm Hg||Standard Deviation|Mean
2600913|NCT02157506|Secondary|Mean Time-Averaged Change From Baseline in Systolic Blood Pressure (SBP) During the Infusion|Mean Time-Averaged Change from Baseline in Systolic Blood Pressure during infusion of CXL-1427 or placebo on a modified intent-to-treat population is presented|Baseline, Hour 24 after infusion, Follow-up visit 1|Modified Intent-To-Treat Analysis Set: all randomized participants who received all or part of the infusion of the study drug and had at least one baseline and post-baseline invasive hemodynamic assessment.|||mm Hg||Standard Deviation|Mean
2600927|NCT02157298|Primary|Adjusted Mean Change in HbA1c Levels|Mean change in HbA1c levels from baseline to Week 16 between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and at least one post-baseline value up to week 16|||percentage of hemoglobin glycosylated||95% Confidence Interval|Least Squares Mean
2600916|NCT02157506|Secondary|Mean Time-Averaged Change From Baseline in Adjudicated Pulmonary Artery Systolic Pressure (PAS) During the Infusion|Pulmonary artery systolic pressure (PAS) was measured by an indwelling PA catheter. The effects of CXL-1427 on time-averaged PAS during the course of the infusion are presented|Baseline, Hour 2, Hour 4, Hour 6, Hour 8 post infusion initiation|Modified Intent-To-Treat Analysis Set: all randomized participants who received all or part of the infusion of the study drug and had at least one baseline and post-baseline invasive hemodynamic assessment.|||mm Hg||Standard Deviation|Mean
2600917|NCT02157506|Primary|Mean Time-Averaged Percent Change From Baseline in Cardiac Index (Fick)|Cardiac index is a measure of cardiac function, relating the cardiac output from the left ventricle in one minute to body surface area. It is calculated using the Fick principle, using oxygen consumption measured with a metabolic cart, hemoglobin levels, and the difference between arterial and superior vena cava oxygen saturation measured by co-oximetry. Cardiac index as calculated by the Fick method was performed using an assumed oxygen consumption value of 125 ml/min per m2 of body surface area. i.e., an assumed Fick method.|Baseline, Hour 2, Hour 4, Hour 6, Hour 8 post infusion initiation|Modified Intent-To-Treat Analysis Set: all randomized participants who received all or part of the infusion of the study drug and had at least one baseline and post-baseline invasive hemodynamic assessment.|||Percentage of change||Standard Deviation|Mean
2600918|NCT02157506|Primary|Mean Time-Averaged Change From Baseline in Adjudicated Pulmonary Artery Diastolic Pressure (PAD) During the Infusion|Pulmonary artery diastolic pressure (PAD) was measured by an indwelling PA catheter. Pulmonary artery diastolic pressure (PAD) approximates pulmonary capillary wedge pressure in normal individuals. The effects of CXL-1427 on time-averaged PAD during the course of the infusion are presented.|Baseline, Hour 2, Hour 4, Hour 6, Hour 8 post infusion initiation|Modified Intent-To-Treat Analysis Set: all randomized patients who received all or part of the infusion of the study drug and had at least one baseline and post-baseline invasive hemodynamic assessment.|||mm Hg||Standard Deviation|Mean
2600919|NCT02157506|Primary|Mean Time Averaged Change From Baseline in Adjudicated Pulmonary Capillary Wedge Pressure (PCWP) During Infusion|The effect of CXL-1427 on PCWP is presented as the mean time-averaged change from baseline over the course of infusion of CXL-1427 or placebo in adjudicated pulmonary capillary wedge pressure (PCWP) on a modified intent-to-treat population|Baseline, Hour 2, Hour 4, Hour 6, Hour 8 post infusion|Modified Intent-To-Treat Analysis Set: all randomized participants who received all or part of the infusion of the study drug and had at least one baseline and post-baseline invasive hemodynamic assessment.|||mm Hg||Standard Deviation|Mean
2600920|NCT02157506|Primary|Number of Participants With Treatment-Emergent Adverse Events|A treatment-emergent adverse event (TEAE) was defined as an AE with onset after the start of the study drug infusion at Hour 00:00 through 30 days after the stop of the study drug infusion. All TEAEs and pertinent subsets of TEAEs (e.g., TEAEs with onset during the infusion of study drug, serious TEAEs, etc.) were summarized by system organ class (SOC), preferred term (PT) and treatment group|30 days following the initiation of treatment|The safety analysis set consists of all randomized participants who received all or part of the infusion of the study drug.|||Participants|||Count of Participants
2600921|NCT02157376|Secondary|Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase|"Criteria for a significant upper GI bleeding as described in primary outcome measure or,~Criteria for a non-significant upper GI bleeding as:~Bright red blood per NG or OG tube that clear after NG or OG tube adjustment and 5 to 10 minutes of lavage with room temperature normal saline or,~Persistent gastroccult- positive coffee ground material~During IMP treatment Day 1-2:~Persistent gastroccult - positive coffee ground material for at less than eight consecutive hours or that clear with at least 100 ml of lavage with room temperature normal saline.~During IMP treatment Day 3-14:~Persistent gastroccult - positive coffee ground material in less than three consecutive gastric aspirates within 2 to 4 hours (at least 60±20 minutes apart), or that clear with at least 100 ml of lavage with room temperature normal saline or,~Any clinical signs of hematemesis or melena or haematochezia judged (by the Investigator) to be from an upper GI source."|1-14 days|Full analysis set (FAS). All randomized patients in whom at least one dose of randomized treatment has been initiated.|||proportion of participants|||Number
2600922|NCT02157376|Primary|The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase|"Criteria for a clinically significant upper GI bleeding as:~Bright red blood per NG or OG tube that did not clear after NG or OG tube adjustment and 5 to 10 minutes of at least 100 ml lavage with room temperature normal saline-or,~Persistent gastroccult- positive coffee ground material~During IMP treatment Day 1-2:~Persistent gastroccult- positive coffee ground material for at least eight consecutive hours that did not clear with at least 100 ml of lavage with room temperature normal saline.~During IMP treatment Day 3-14:~Persistent gastroccult- positive coffee ground material in at least three consecutive gastric aspirates within 2 to 4 hours (at least 60 ±20 minutes apart), that did not clear with at least 100 ml of lavage with room temperature normal saline."|1-14 days|Full analysis set (FAS). All randomized patients in whom at least one dose of randomized treatment has been initiated.|||% of participants|||Number
2600923|NCT02157298|Secondary|Proportion of Participants With Mean Daily Insulin Dose Reduction of Greater Than or Equal 10%|Proportion of participants with mean daily insulin dose reduction greater than or equal 10% from baseline to week 16 (LOCF) between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and Week 16 (LOCF) value|||percentage of participants||95% Confidence Interval|Least Squares Mean
2600924|NCT02157298|Secondary|Total Mean Daily Insulin Dose|Mean change in calculated mean daily insulin dose from baseline to Week 16 between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and at least one post-baseline value up to week 16|||IU/Day||95% Confidence Interval|Least Squares Mean
2600925|NCT02157298|Secondary|Total Body Weight|Mean change in total body weight from baseline to Week 16 between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and at least one post-baseline value up to week 16|||kg||95% Confidence Interval|Least Squares Mean
2600926|NCT02157298|Secondary|Fasting Plasma Glucose|Mean change in fasting plasma glucose from baseline to Week 16 between dapagliflozin 5 mg versus placebo|Baseline to Week 16|Full Analysis Set, participants with non-missing baseline and at least one post-baseline value up to week 16|||mg/dL||95% Confidence Interval|Least Squares Mean
2600928|NCT02157168|Other Pre-specified|Informed Decision Making Regarding the Healthcare System and Their Health|The short form of the Patient Activation Measure (PAM), a measure of patient engagement in their healthcare. PAM levels of engagement with Level 4 being the highest level.|Baseline and 6 months|IG1 group members that completed the baseline and 6-month survey and CG and IG2 group members that complete the 6-month survey.|||Participants|||Count of Participants
2600929|NCT02157168|Secondary|The Impact of the Intervention on Preventable Hospital Stays|The number and percentage of new members who had avoidable hospitalizations during their first 6 months of enrollment.|6 months|Members who had a hospital visit during the first 6 months of enrollment.|||Participants|||Count of Participants
2600930|NCT02157168|Secondary|The Impact of the Intervention on the Utilization of Avoidable Emergency Department (ED) Visits|The number and percentage of new members who had avoidable emergency department (ED) visits during their first 6 months of enrollment.|6 months|Members who had an ED visit during the first 6 months of their enrollment.|||Participants|||Count of Participants
2600931|NCT02157168|Secondary|The Impact of the Intervention on the Utilization of Women's Preventive Services and Other Preventive Services|The number and percentage of new members who had at least one preventive visit (i.e., well woman visit, cervical cancer screening, sexually transmitted infection (STI) screening, STI counseling, contraception counseling or immunizations) during their first 6 months of enrollment.|6 months||||Participants|||Count of Participants
2600932|NCT02157168|Primary|Identify and Utilization of Primary Care Provider (PCP)|The number and percentage of new members who had at least one visit with a primary care provider during their first 6 months of enrollment.|6 months||||Participants|||Count of Participants
2600933|NCT02157116|Secondary|Overall Survival||Approximately 10 years|Due to insufficient accrual, the study was stopped prior to completing the 10 year followup for survival.||||||
2600934|NCT02157116|Secondary|Number of Patients Who Were Able to Maintain Hemoglobin Between 11-13 g/dL During Induction||During induction, approximately 6 weeks|Due to insufficient accrual, data analysis was not performed.||||||
2600935|NCT02157116|Secondary|Number of Grade III/IV Non-hematologic Adverse Events||During induction chemotherapy, approximately 6 weeks|Due to insufficient accrual, data analysis was not performed.||||||
2600936|NCT02157116|Secondary|Number of Grade III/IV Hematologic Adverse Events||During induction chemotherapy, approximately 6 weeks|Due to insufficient accrual, data analysis was not performed.||||||
2600937|NCT02157116|Primary|Differential Gene Expression Between Responsive and Resistant Tumor Treated With Dose-dense Therapy||at the end of the study, estimated 2.5 years|Due to insufficient accrual, gene analysis was not performed.||||||
2600938|NCT02157116|Primary|Induction Response|Response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Response is defined as the number patients with a Complete Response (CR), disappearance of all target lesions, or a Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions.|Between 2 and 3 weeks after induction|Due to insufficient accrual, data analysis was not performed.||||||
2600939|NCT02157103|Secondary|Number of Participants With Change in Edema After Conversion From Study Treatment to Intravenous Bevacizumab|Participants may switch from subcutaneous bevacizumab on study to standard of care intravenous bevacizumab. In these participants, we will measure decrease of edema after this switch. A further decrease in edema after making this switch would suggest intravenous to be superior to subcutaneous as regards decreasing edema. The therapeutic benefit of bevacizumab as regards GBM is largely due to the normalization of brain vasculature. This normalization appears on contrast-enhanced MRI as a reduction in edema. For purposes of this study, any reduction in edema by 25% or more will be considered a response.|Within 2 months of starting intravenous bevacizumab|One patient did not switch to standard of care intravenous bevacizumab.|||Participants|||Count of Participants
2600940|NCT02157103|Secondary|Number of Toxicities Reported in Study Participants|Subcutaneous bevacizumab may have toxicities unique to the subcutaneous administration and not seen with intravenous bevacizumab. During the first 3 weeks we will watch for such toxicities. Toxicities will be described and graded using the Common Toxicity Criteria for Adverse Effects (CTCAE) v3.|During first 3 weeks of study||||Toxicities|||Number
2600941|NCT02157103|Primary|Number of Participants With Change in Peritumoral Enhancement/Edema|To describe MRI response regarding edema and enhancement of glioblastoma and radiation-related brain enhancement when treated with subcutaneous bevacizumab daily. The therapeutic benefit of bevacizumab as regards glioblastoma multiforme (GBM) is largely due to the normalization of brain vasculature. This normalization appears on contrast-enhanced MRI as a reduction in enhancement and reduction in edema. For purposes of this study, any reduction in enhancement/edema by 25% or more will be considered a response.|1 cycle (3 weeks)||||Participants|||Count of Participants
2600942|NCT02156804|Secondary|Overall Survival|The time from first dosing date to the date of death.|Up to 4 years|All Treated Participants|||Months||95% Confidence Interval|Median
2600943|NCT02156804|Secondary|Median Time to Resolution (Grades 3-4) of Select Adverse Events|Select AEs were summarized according to their incidence as well as their time to resolution|Up to 2 years|All Treated Participants|||Weeks||Full Range|Median
2600944|NCT02156804|Secondary|Median Time to Onset (Grades 3-4) of Select Adverse Events|Select AEs were summarized according to their incidence as well as their time to onset.|Up to 2 years.|All Treated Participants.|||Weeks||Full Range|Median
2600945|NCT02156804|Secondary|The Incidence of All High-grade (Grades 3 and Higher), Select Adverse Events|The number of Participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), select AEs were summarized using the all treated analysis set by system organ class and MedDRA preferred term.|Up to 2 years|All treated Participants|||Number of Participants|||Number
2600946|NCT02156804|Primary|the Incidence of Highgrade (CTCAE v4.0 Grade 3 or Higher), Treatment Related,Select Adverse Events.|The number of participants who reported high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select AEs (pulmonary,gastrointestinal, skin, renal, hepatic, endocrine) were summarized using the all treated analysis set by system organ class and Medical Dictionary for Regulatory (MedDRA) preferred term.|Up to 2 years|All treated participants|||Number of Participants|||Number
2600947|NCT02156492|Secondary|Effect of Evacetrapib Single and Multiple Doses on High Density Lipoprotein Cholesterol (HDL-C), Low Density Lipoprotein Cholesterol (LDL-C), and Triglycerides (TG)||Single Dose Day 2 and Multiple Dose Day 22|All participants who received at least one dose of study drug in Cohort A.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2600948|NCT02156492|Primary|PK: Tmax of Evacetrapib Alone and With Simvastatin or Atorvastatin|Pharmacokinetic parameter estimates of Tmax of evacetrapib following 130 mg daily dose alone or with 40 mg Simvastatin or 20 mg Atorvastatin. Tmax of simvastatin and atorvastatin.|Part 2: Predose on Day 14 and 22 and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose.|All participants who received at least one dose of study drug in Cohort B and C and had evaluable PK data.|||h||Full Range|Median
2600949|NCT02156492|Primary|PK: Cmax of Evacetrapib Alone and With Simvastatin or Atorvastatin|Pharmacokinetic parameter estimates of evacetrapib following 130 mg evacetrapib daily alone or with 40 mg simvastatin or 20 mg atorvastatin daily.|Part 2: Day 14 and 22 Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours Postdose.|All participants who received at least one dose of study drug in Cohort B and C and had evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2600950|NCT02156492|Primary|PK: AUC of Evacetrapib Alone and With Simvastatin or Atorvastatin|Pharmacokinetic parameter estimates of evacetrapib following 130 mg evacetrapib daily alone or with 40 mg simvastatin or 20 mg atorvastatin daily AUC (0-24).|Part 2: Day 14 and 22 Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours Postdose|All participants who received at least one dose of study drug in Cohort B and C and had evaluable PK data|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2600951|NCT02156492|Primary|PK: Time to Maximum Concentration (Tmax) of Evacetrapib|Pharmacokinetic parameter estimates of evacetrapib following single and daily doses of 130 mg evacetrapib.|Part 1: Day 1 Predose on Day 1 or Day 14 and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours postdose. Part 2: Predose on Day 14 at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose.|All participants who received at least one dose of study drug in Cohort A.|||hours (h)||Full Range|Median
2600952|NCT02156492|Primary|PK: Maximum Concentration (Cmax) of Evacetrapib|Pharmacokinetic parameter estimates from evacetrapib following single dose and daily doses of 130 mg.|Part 1: Day 1 and Day 14 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours Postdose; Part 2 Day 14: Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours Postdose|All participants who received at least one dose of study drug in Cohort A.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2600953|NCT02156492|Primary|Pharmacokinetics (PK): Area Under Curve (AUC 0-inf) of Evacetrapib|Pharmacokinetic (PK) parameter estimates from evacetrapib concentrations following single dose and daily dose of 130 mg evacetrapib.|Part 1: Day 1 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours Postdose; Part 2 Day 14 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours Postdose|All participants who received at least one dose of study drug in Cohort A.|||nanogram * hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2600954|NCT02156466|Secondary|Percentage of Subjects With Exacerbation of Psoriasis|Psoriasis exacerbation was defined as either a worsening of 25% over the baseline value of the PASI score (PASI score at any visit >=125% of baseline PASI).|Baseline up to Day 85|Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).|||percentage of subjects|||Number
2600955|NCT02156466|Secondary|Mean Percent Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Day 8, 15, 22, 29, 36, 43, 50 and 85|The BSA is the physician's evaluation for the extent of disease. The entire body area is divided into 4 districts: head, upper limbs, trunk and lower limbs to which corresponds the 10%, 20%, 30% and 40% of the entire body surface respectively. The investigator assesses the percentage of the subjects' body surface area affected by psoriasis in each district. The final affected BSA value is the sum of the percentage of each district.|Baseline, Day 8, 15, 22, 29, 36, 43, 50 and 85|"Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo). Here n signifies those subjects who were evaluable for this outcome measure at the specified time points."|||percent change||Standard Deviation|Mean
2600956|NCT02156466|Secondary|Percentage of Subjects With Static Physician's Global Assessment (sPGA) Score of Minimal or Clear and With at Least 2 Level Reduction From Baseline|The static Physician's Global Assessment (sPGA) scale rated the investigator's overall clinical assessment of a subjects plaque thickness, erythema, and scaling on a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (majority of plaques have severe thickness, erythema, and scale). To assign a sPGA score, the investigator examined all psoriatic lesions and assigned a severity score ranging from 0 to 5 for thickness, erythema, and scaling. Scores for thickness, erythema, and scaling are summed and the mean of these 3 scores equals the overall sPGA score. Overall sPGA score ranged from 0 to 5, where lower scores indicate clinical improvement. Percentage of subjects who achieved a sPGA rating of 0 (clear) or 1 (minimal) and had at Least 2 level reduction from Baseline score were reported.|Day 8, 15, 22, 29, 36, 43, 50, 85|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).|||percentage of subjects|||Number
2600957|NCT02156466|Secondary|Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 43|PASI: a physician assessed index that measured psoriasis severity and evaluated erythema, infiltration, and desquamation (scaling) on different body areas including the head, upper extremities, the trunk, and lower extremities. T Erythema, infiltration, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. PASI score ranged from 0 to 72, with higher scores reflecting greater disease severity. PASI 50% or 75% was defined as the percentage of subjects who achieved >=50 or 75% improvement in PASI score from Baseline.|Baseline, Day 43|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).|||units on a scale||Standard Deviation|Mean
2600968|NCT02156466|Primary|Apparent Terminal Half-life (t1/2) Post Third Dose of MSB0010841|Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/ λz, where 'λz' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||day||Geometric Coefficient of Variation|Geometric Mean
2600958|NCT02156466|Secondary|Percentage of Subjects With 50% or 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score|PASI: a physician assessed index that measured psoriasis severity and evaluated erythema, infiltration, and desquamation (scaling) on different body areas including the head, upper extremities, the trunk, and lower extremities. T Erythema, infiltration, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) was multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score. PASI score ranged from 0 to 72, with higher scores reflecting greater disease severity. PASI 50% or 75% was defined as the percentage of participants who achieved >=50 or 75% improvement in PASI score from Baseline.|Baseline up to Day 85|Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).|||percentage of subjects|||Number
2600959|NCT02156466|Primary|Observed Serum Concentration Immediately Before Second Dose (Cpre) of MSB0010841|The observed serum concentration immediately before second dose.|Pre-dose (0 hours) on Day 15|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2600960|NCT02156466|Primary|Maximum Observed Concentration (Cmax) Post Second Dose of MSB0010841||0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)|"PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2600961|NCT02156466|Primary|Accumulation Ratio of AUC (Racc(AUC))|Accumulation ratio for AUC, calculated as area under the serum concentration-time curve within one complete dosing interval at third dose divided by area under the serum concentration-time curve within one complete dosing interval at first dose.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2600962|NCT02156466|Primary|Accumulation Ratio of Cmax (Racc (Cmax))|Accumulation ratio for Cmax was calculated as Cmax, after third dose / Cmax, after first dose.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1) and 0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2600963|NCT02156466|Primary|Percentage Peak-Trough Fluctuation (PTF) Post Third Dose of MSB0010841|The peak trough fluctuation within one dosing interval, calculated as PTF (%) = ([Cmax - Cmin]/Cav ) multiplied by 100|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|"PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."|||percentage fluctuation||Geometric Coefficient of Variation|Geometric Mean
2600964|NCT02156466|Primary|Percentage Peak-Trough Fluctuation (PTF) Post First Dose of MSB0010841|The peak trough fluctuation within one dosing interval, calculated as PTF (%) = ([Cmax - Cmin]/Cav ) multiplied by 100|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|"PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."|||percentage fluctuation||Geometric Coefficient of Variation|Geometric Mean
2600965|NCT02156466|Primary|Apparent Volume of Distribution During Terminal Phase (Vz/f) Post Third Dose of MSB0010841|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by elimination rate constant [λz]) following first dose and Dose/(AUCtau multiplied by λz) after third dose.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|"PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."|||Liters||Geometric Coefficient of Variation|Geometric Mean
2600966|NCT02156466|Primary|Apparent Clearance (CL/f) Post Third Dose of MSB0010841|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||L/day||Geometric Coefficient of Variation|Geometric Mean
2600967|NCT02156466|Primary|Terminal Rate Constant (λz) Post Third Dose of MSB0010841|Terminal rate constant was determined from the terminal slope of the logtransformed concentration curve using linear regression on terminal data points of the curve|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||1/hour||Geometric Coefficient of Variation|Geometric Mean
2620695|NCT01953328|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2600969|NCT02156466|Primary|Time to Reach Maximum Observed Concentration (Tmax) Post Third Dose of MSB0010841||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||hour||Full Range|Median
2600970|NCT02156466|Primary|Time to Maximum Observed Concentration (Tmax) Post Second Dose of MSB0010841||0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||hour||Full Range|Median
2600971|NCT02156466|Primary|Time to Reach Maximum Observed Concentration (Tmax) Post First Dose of MSB0010841||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||hour||Full Range|Median
2600972|NCT02156466|Primary|Mean Residence Time of Drug in the Body From Time Zero Extrapolated to Infinity (MRT(0-inf) Post Third Dose of MSB0010841|Mean residence time of drug in the body from time zero extrapolated to infinity, based on the last predicted concentration at tlast.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||day||Geometric Coefficient of Variation|Geometric Mean
2600973|NCT02156466|Primary|Mean Residence Time (MRT0-t) Post Third Dose of MSB0010841|MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||day||Geometric Coefficient of Variation|Geometric Mean
2600974|NCT02156466|Primary|Mean Residence Time (MRT0-t) Post First Dose of MSB0010841|MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(0-t)/AUC(0-t) where AUMC(0-t) is area under the plasma concentration-time first moment curve from time zero to time t (336 hours) and AUC(0-t) is the area under the plasma concentration-time curve from time zero to tome t (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||day||Geometric Coefficient of Variation|Geometric Mean
2600975|NCT02156466|Primary|Average Concentration (Cav) Post Third Dose of MSB0010841|Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2600976|NCT02156466|Primary|Average Concentration (Cav) Post First Dose of MSB0010841|Cav was calculated by AUCtau/tau. Where tau is the dosing interval (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2600977|NCT02156466|Primary|Maximum Concentration Observed (Cmax) Post Third Dose of MSB0010841||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2600978|NCT02156466|Primary|Maximum Concentration Observed (Cmax) Post First Dose of MSB0010841||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2600979|NCT02156466|Primary|Minimum Concentration Observed (Cmin) During Third Dosing Interval of MSB0010841|The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2600980|NCT02156466|Primary|Minimum Concentration Observed (Cmin) During First Dosing Interval of MSB0010841|The observed minimum serum concentration determined directly from the serum concentration-time profile of each subject.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2601725|NCT02150837|Secondary|Abdominal Circumference|Abdominal circumference expressed as an absolute change from baseline.|12 weeks|Not all subjects remaining at 12 weeks had measurement performed.|||Inches||Standard Deviation|Mean
2600981|NCT02156466|Primary|Observed Serum Concentration Immediately Before Third Dose (Cpre) of MSB0010841|The observed serum concentration immediately before the third dose.|Pre-dose (0 hours) on Day 29|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2600982|NCT02156466|Primary|Observed Serum Concentration Immediately Before First Dose (Cpre) of MSB0010841|The observed serum concentration immediately before the first dose.|Pre-dose (0 hours) on Day 1|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2600983|NCT02156466|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) Post Third Dose of MSB0010841|Area under the serum concentration-time curve from time zero to infinity (AUC0-inf). AUC0-infcalculated as AUC0-t + AUCextra. AUCextra represents the extrapolated part of AUC0-inf calculated by Clast calc/λz, where Clast calc is the calculated concentration at the last sampling time point at which the measured concentration is at or above LLOQ and λz is the terminal rate constant determined from the terminal slope of the log transformed concentration curve using linear regression on terminal data points of the curve.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||day*ug/mL||Geometric Coefficient of Variation|Geometric Mean
2600984|NCT02156466|Primary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post Third Dose of MSB0010841|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2600985|NCT02156466|Primary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) Post First Dose of MSB0010841|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2600986|NCT02156466|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post Third Dose of MSB0010841|Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above LLOQ.|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2600987|NCT02156466|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) Post First Dose of MSB0010841|Area under the serum concentration-time curve (AUC) from time zero to the last sampling time point at which the concentration is at or above lower limit of quantification (LLOQ).|0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||day*microgram per milliliter (day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2600988|NCT02156466|Primary|MSB0010841 Serum Concentration Over Time After Third Dose||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336, 504, 816, 1056, 1344 hours post-third dose (Day 29)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||ng/mL||Standard Deviation|Mean
2600989|NCT02156466|Primary|MSB0010841 Serum Concentration Over Time After Second Dose||0 hours (pre-dose), 24, 72, 96, 168, 336 hours post-second dose (Day 15)|PK analysis set included subjects who received active treatment (MSB0010841) without protocol deviations affecting PK, and who provide evaluable PK data. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||ng/mL||Standard Deviation|Mean
2600990|NCT02156466|Primary|MSB0010841 Serum Concentration Over Time After First Dose||0 hours (pre-dose), 6, 12, 24, 32, 72, 96, 168, 336 hours post-first dose (Day 1)|PK analysis set included subjects who received first dose of MSB0010841 without protocol deviations affecting PK, and who provide evaluable PK data. Here “n” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2600991|NCT02156466|Primary|Levels of Pre-existing Anti-MSB0010841 Antibody Titers||Pre-dose on Day 1|All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration were included in the analysis population.|||log10titer|||Number
2600992|NCT02156466|Primary|Levels of Anti-MSB0010841 Antibody Titers||Day 8, 15 (pre-dose), 22, 29 (pre-dose), 36, 43, 63 and 85|All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration were included in the analysis population.|||log10titer|||Number
2600993|NCT02156466|Primary|Percentage of Subjects With Anti-MSB0010841 Binding Antibodies (Anti-Drug Antibodies [ADA])|Data were presented for MSB0010841 combined group and placebo.|Baseline up to Day 85|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo).|||percentage of subjects|||Number
2600994|NCT02156466|Primary|Amount of Pain at Injection Site Assessed By Visual Analog Scale (VAS)|Subjects were asked to assess their severity of injection site pain on a 100 millimeter (mm) VAS, where 0 = no pain and 100 = worst possible pain. Mean of amount of pain was calculated for the subjects having a value > 0. Maximum values per subjects (over injection site areas) are used for counting the amount of pain at injection site. Maximum pain scores recorded among all participants analysed in each arm are reported for each time point.|Day 1, 2, 8, 15, 16, 22, 29, 30, 36, 43|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo). Here “Number of subjects analyzed” signifies those subjects who were evaluable for this endpoint and “n” signifies those subjects who were evaluable at the specified time point.|||mm|||Number
2600995|NCT02156466|Primary|Number of Subjects With Local Injection Site Reactions (ISRs)|The injection site was assessed by the Principal Investigator (PI) or his/her designee for local reactions such as redness, swelling, indurations or bruising, and by the subject for itching. Redness and bruising were scaled as None (no visible redness or bruising present); Mild (less than or equal to [<=] 2.0 centimeters [cm] redness or bruising area); Moderate (greater than [>] 2 to <=5.0 cm redness or bruising area); Severe (>5.0 cm redness or bruising area). Swelling was scaled as None (no swelling detected); Mild (palpable 'firmness' only); Moderate (<= 4 cm swelling); Severe (>4 cm swelling). Induration was scaled as None (no induration); Mild (able to move skin parallel to plane (sliding) and perpendicular to skin (pinching up); Moderate (able to slide skin, unable to pinch skin); Severe (unable to slide or pinch skin). Itching was scaled as No itching; Mild itching; Moderate itching and Severe itching. Subjects who reported any of the local ISRs were reported.|Day 1, 2,8, 15, 16, 22, 29, 30, 36, 43|Safety analysis set included all 41 subjects who received at least one dose of IMP (MSB0010841 or placebo). Here “n” signifies those subjects who were evaluable for the specified injection site reaction. Subjects may be represented in more than 1 category.|||subjects|||Number
2600996|NCT02156466|Primary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. TEAEs were the AEs occurring or worsening after treatment administration.|Baseline up to Day 85|Safety analysis set included all 41 subjects who received at least 1 dose of IMP (MSB0010841 or placebo).|||subjects|||Number
2600997|NCT02156271|Secondary|Interleukin 6 (IL-6)||Baseline||||pg/mL||Standard Deviation|Mean
2600998|NCT02156271|Secondary|Insulin Resistance (IR)|In each subject, an insulin resistance score based on Homeostasis Model Assessment (HOMA-IR) was estimated at baseline. Formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).|Baseline||||HOMA-IR value||Standard Deviation|Mean
2600999|NCT02156271|Secondary|Inflammatory Biomarkers C-reactive Protein (CRP)||Baseline||||mg/L||Standard Deviation|Mean
2601000|NCT02156271|Primary|Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)|The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects.|Baseline||||minutes||Standard Deviation|Mean
2601001|NCT02156271|Primary|Mean Latency to Persistent Sleep (LPS) Via Polysomnography|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured.|Baseline||||minutes||Standard Deviation|Mean
2601002|NCT02156271|Primary|Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)|Subjects completed component 2 of the PSQI questionnaire. Component 2 asks questions about sleep latency and is scored on a scale from 0 (better) to 3 (worse).|day 89 - 90||||units on a scale||Standard Deviation|Least Squares Mean
2601003|NCT02156271|Secondary|Insulin Resistance (IR)|In each subject, an insulin resistance score based on Homeostasis Model Assessment (HOMA-IR) was estimated at day 89-90. Formula: fasting plasma glucose (mmol/l) times fasting serum insulin (mU/l) divided by 22.5. Low HOMA-IR values indicate high insulin sensitivity, whereas high HOMA-IR values indicate low insulin sensitivity (insulin resistance).|Day 89-90||||HOMA-IR value||Standard Deviation|Least Squares Mean
2601004|NCT02156271|Secondary|Interleukin 6 (IL-6)||Day 89-90||||pg/mL||Standard Deviation|Least Squares Mean
2601005|NCT02156271|Secondary|Inflammatory Biomarkers C-reactive Protein (CRP)||Day 89-90||||ng/mL||Standard Deviation|Least Squares Mean
2601006|NCT02156271|Secondary|Change in Total Sleep Time|Change in sleep time will be determined by PSG.|Day -1-0, Day 89-90|Data was not collected, and therefore not analyzed.||||||
2601007|NCT02156271|Primary|Sleep Onset Latency (SOL) as Measured by Pittsburgh Sleep Qualtiy Index (PSQI)|Subjects completed component 2 of the PSQI questionnaire. Component 2 asks questions about sleep latency and is scored on a scale from 0 (better) to 3 (worse).|baseline||||units on a scale||Standard Deviation|Mean
2601008|NCT02156271|Primary|Change in Metabolic Syndrome (MetSyn)||Baseline, Day 30, Day 60, Day 89-90|Data was not collected, and therefore not analyzed.||||||
2601009|NCT02156271|Primary|Mean Latency to Persistent Sleep (LPS) Via Polysomnography|Elapsed time from the beginning of the Polysomnography recording to the onset of the first 20 minutes of continuous sleep was measured.|Day 89-90||||minutes||Standard Deviation|Least Squares Mean
2601010|NCT02156271|Primary|Sleep Onset Latency (SOL) as Measured by Self Report (Sleep Diary)|The average of a week of sleep onset latency data from the sleep diary filled out in the morning by the participating subjects. Sleep latency is defined as the length of time it takes from lying down for the night until sleep onset.|Day 89-90||||minutes||Standard Deviation|Least Squares Mean
2601024|NCT02155985|Secondary|Change in Brachial Artery Flow-mediated Dilation (FMD) From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percentage of brachial artery diameter||95% Confidence Interval|Mean
2601025|NCT02155985|Secondary|Change in Urine Thromboxane Per Creatinine From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||fold change||95% Confidence Interval|Mean
2601011|NCT02156167|Primary|Aided Speech Reception Threshold (SRT) in Noise Measured by Signal to Noise Ratio for 50% Correct Scores With the Oldenburger Sentence Test|"The Oldenburger Sentence test is an adaptive speech in noise test with a fixed noise level of typically 65 decibel (dB) sound pressure level (SPL) and a varying speech level, depending on how many words in a sentence were repeated correctly by the subject. The outcome of this test is the signal-to-noise ratio (SNR) at which 50% of words in the sentence list were correctly repeated by the subject. The SRT in noise with the Freedom sound processor at the initial study visit was compared to the SRT in noise with the CP810 at the 3 months follow-up at different measurement conditions.~Speech and noise coming from the front (S0N0)- Speech coming from the front and noise coming from the implanted side (S0N90)- Everyday program (E): omnidirectional microphone- Noise program (N): directional microphone- Freedom Sound Processor (Freedom)- CP810 Sound Processor (CP810)."|3 months after initial upgraded fitting|One subject did not visit the clinic for the 3 months follow-up, a second subject did not perform the speech in noise test at the 3 months follow-up due to tiredness|||dB SNR||Standard Deviation|Mean
2601012|NCT02156076|Secondary|Average Duration of Atrial Fibrillation Per Episode|The average duration of AF per episode was calculated from the total time a participant in AF and the total number of AF episodes over the monitoring period.|Day 8 to Day 29|Data was not collected for any participants due to termination of the study||||||
2601013|NCT02156076|Secondary|Total Number of Atrial Fibrillation Episodes|The total number AF episodes were derived from AF episode histogram data over the monitoring period.|Day 8 to Day 29|Data was not collected for any participants due to termination of the study||||||
2601014|NCT02156076|Secondary|Time to First Atrial Fibrillation Recurrence (TTFR) (Symptomatic or Asymptomatic)|"The TTFR is defined as the time to the first MCT-recorded AF episode after the first loading dose on Day 1. MCT will provide both System-triggered and Patient-triggered results and report them separately. System-triggered results will include both symptomatic and asymptomatic findings, while Patient-triggered results will be the symptomatic ones triggered to report by patients. The analysis will be done both for System-triggered and for Patient-triggered results."|Day 8 to Day 29|Data was not collected for any participants due to termination of the study||||||
2601015|NCT02156076|Secondary|Area Under the Concentration-time Curve (AUC) at Steady State of BMS-919373|AUC is defined as the area under the concentration-time curve at steady state.|Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)|Data was not collected for any participants due to termination of the study||||||
2601016|NCT02156076|Secondary|Average Concentration (Cavg) of BMS-919373 at Steady State|Cavg is defines as the average concentration at steady state.|Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)|Data was not collected for any participants due to termination of the study||||||
2601017|NCT02156076|Secondary|Absorption Rate Constant (Ka) of BMS-919373|Ka is the absorption rate constant.|Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)|Data was not collected for any participants due to termination of the study||||||
2601018|NCT02156076|Secondary|Central Volume of Distribution (Vc/F) of BMS-919373|Volume of distribution is defined as the theoretical volume in which the total amount of drug is uniformly distributed to produce the desired plasma concentration of a drug. Vc/F is a hypothetical volume into which a drug initially distributes upon administration.|Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)|Data was not collected for any participants due to termination of the study||||||
2601019|NCT02156076|Secondary|Oral Clearance (CL/F) of BMS-919373|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)|Data was not collected for any participants due to termination of the study||||||
2601020|NCT02156076|Secondary|Trough Observed Concentration (Cmin) of BMS-919373|Ctrough is defined as the minimum estimated plasma concentration at steady state.|Day 8 (predose), Day 22 (predose, 1, 2, and 4 hours postdose), and Day 29 (24 hours after last dose of Day 28)|Data was not collected for any participants due to termination of the study||||||
2601021|NCT02156076|Secondary|Maximum Observed Concentarion (Cmax) of BMS-919373|Cmax is defined as the maximum observed concentration of BMS-919373.|Day 1 and Day 22: Predose 1, 2, and 4 hours postdose|Data was not collected for any participants due to termination of the study||||||
2601022|NCT02156076|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs and Death|An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect.|Up to Day 50|All treated participants included all the participants who have received at least one dose of study treatment.|||Participants|||Number
2601023|NCT02156076|Primary|Percent Change From Baseline in Atrial Fibrillation Burden (AFB) as Assessed by SEEQ Mobile Cardiac Telemetry (MCT) System|AFB is defined as the percent of time spent in atrial fibrillation (AF). AFB will be assessed by use of long term non- invasive beat-to-beat monitoring with the SEEQ MCT system. This technology consists of a low-profile adhesive patch that has been approved for continuous use for up to 30 days. The patch is able to continuously record electrocardiographic signals and, in conjunction with a wirelessly connected portable cellular communications device, transmit these signals for real-time analysis, including atrial and ventricular arrhythmias and AFB.|Day 8 to Day 29|Data was not collected for any participants due to termination of the study||||||
2601027|NCT02155985|Secondary|Change in Kynurenine to Tryptophan Ratio From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||1000 ng/ml kynurenine : ng/ml tryptophan||95% Confidence Interval|Mean
2601028|NCT02155985|Secondary|Change in D-dimer From Baseline to Week 11/12|"Baseline is defined as the average of the Pre-Entry and Entry values. Week 11/12 is defined as the average of the Week 11 and Week 12 values. All values were log10 transformed prior to calculating change and conducting analyses. Values obtained within 6 days after the influenza vaccination were excluded.~Absolute change was calculated as the value at week 11/12 minus the value at baseline. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change."|Pre-entry and entry to weeks 11 and 12|Analysis used the per-protocol population as in the primary analyses.|||fold change||95% Confidence Interval|Mean
2601029|NCT02155985|Secondary|Change in IL-6 From Baseline to Week 11/12|"Baseline is defined as the average of the Pre-Entry and Entry values. Week 11/12 is defined as the average of the Week 11 and Week 12 values. All values were log10 transformed prior to calculating change and conducting analyses. Values obtained within 6 days after the influenza vaccination were excluded.~Absolute change was calculated as the value at week 11/12 minus the value at baseline. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change."|Pre-entry and entry to weeks 11 and 12|Analysis used the per-protocol population as in the primary analyses.|||fold change||95% Confidence Interval|Mean
2601030|NCT02155985|Secondary|Change in Expression of PD-1+ on CD8+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percentage of CD8+ expressing PD-1+||95% Confidence Interval|Mean
2601031|NCT02155985|Secondary|Change in Expression of PD-1+ on CD4+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percentage of CD4+ expressing PD-1+||95% Confidence Interval|Mean
2601032|NCT02155985|Secondary|Change in Expression of CD38+HLA-DR+ on CD8+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percent of CD8+ expressing CD38+HLA-DR+||95% Confidence Interval|Mean
2601033|NCT02155985|Secondary|Change in Expression of CD38+HLA-DR+ on CD4+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percent of CD4+ expressing CD38+HLA-DR+||95% Confidence Interval|Mean
2601034|NCT02155985|Secondary|Change in Expression of CD69+ on CD14+CD16+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percent of CD14+CD16+ expressing CD69+||95% Confidence Interval|Mean
2601035|NCT02155985|Secondary|Change in Expression of CD14+CD16+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percentage of CD14+CD16+||95% Confidence Interval|Mean
2601036|NCT02155985|Secondary|Change in Expression of CD69+ on CD14+CD16- From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percent of CD14+CD16- expressing CD69+||95% Confidence Interval|Mean
2601037|NCT02155985|Secondary|Change in Expression of CD14+CD16- From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percentage of CD14+CD16-||95% Confidence Interval|Mean
2601038|NCT02155985|Secondary|Change in Expression of CD69+ on CD14dimCD16+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percent of CD14dimCD16+ expressing CD69+||95% Confidence Interval|Mean
2601039|NCT02155985|Secondary|Change in Expression of CD14dimCD16+ From Entry to Week 12|Absolute change was calculated as the value at week 12 minus the value at entry.|Entry to Week 12|Analysis used the per-protocol population as in the primary analyses.|||percentage of CD14dimCD16+||95% Confidence Interval|Mean
2601040|NCT02155985|Secondary|Change in sCD163 From Baseline to Week 11/12|"Baseline is defined as the average of the Pre-Entry and Entry values. Week 11/12 is defined as the average of the Week 11 and Week 12 values. All values were log10 transformed prior to calculating change and conducting analyses. Values obtained within 6 days after the influenza vaccination were excluded.~Absolute change was calculated as the value at week 11/12 minus the value at baseline. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change."|Pre-entry and entry to weeks 11 and 12|Analysis used the per-protocol population as in the primary analyses.|||fold change||95% Confidence Interval|Mean
2601041|NCT02155985|Secondary|Tolerability|Tolerability was summarized as the number of participants successfully completing the protocol-defined treatment period.|Treatment dispensation to Week 12|All randomized participants.|||Participants|||Count of Participants
2601042|NCT02155985|Secondary|Safety|"Safety was summarized as the highest grade sign/symptom, laboratory event, or diagnosis per participant.~Grading (Grade 0: normal, Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening) was done by site clinicians using DAIDS AE Grading table."|After study entry to Week 16|All randomized participants.|||Participants|||Count of Participants
2601057|NCT02155712|Secondary|Compare 2011 Knee Society Score (KSS) Scores Between Both Groups|"The 2011 Knee Society Score System is comprised of 4 distinct sub-scores: Objective, Functional, Satisfaction, and Expectations. The Objective and Functional sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. The Patient Satisfaction sub-score ranges from a potential minimum score of 0 to a maximum score of 40 points. The Subject Expectations sub-score ranges from a potential minimum score of 0 to a maximum score of 15 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome."|2 years|||||||
2601058|NCT02155712|Secondary|Implant Survivorship (Baseplate and Patella)|This outcome measure will be entered at the 10-year time point.|10 years|||||||
2601043|NCT02155985|Primary|Change in sCD14 From Baseline to Week 11/12|"Baseline is defined as the average of the Pre-Entry and Entry values. Week 11/12 is defined as the average of the Week 11 and Week 12 values. All values were log10 transformed prior to calculating change and conducting analyses. Values obtained within 6 days after the influenza vaccination were excluded.~Absolute change was calculated as the value at week 11/12 minus the value at baseline. Mean changes were exponentiated to be back on the untransformed scale and corresponds to a mean fold change. Differences between arms are expressed as the percent difference between mean fold changes."|Pre-entry and entry to weeks 11 and 12|Analysis used the per-protocol population. Participants 1) without baseline AND week 11/12 sCD14 values, or 2) with premature discontinuation of study treatment, or 3) with a serious bacterial infection while on treatment, or 4) with <70% self-reported adherence (based on all available days of recall) to study treatment were excluded.|||fold change||95% Confidence Interval|Mean
2601044|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Individual Domain Score|The RQLQ is a 28-item, disease-specific quality of life questionnaire that measures the functional (physical, emotional, and social) problems troublesome to adults with allergies. The RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional). All 28 questions were evaluated by the participant in an assessment diary over 2 weeks of treatment period and was rated on a 7-point severity scale ranging from 0 to 6, where 0 = least severe to 6 = extremely severe. Overall domain scores were calculated by taking the mean of the response of the relevant questions. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.|||scores on a scale||Standard Deviation|Mean
2601045|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score|The RQLQ is a 28-item, disease-specific quality of life questionnaire that measures the functional (physical, emotional, and social) problems troublesome to adults with allergies. The RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional). All 28 questions were evaluated by the participant in an assessment diary over 2 weeks of treatment period and was rated on a 7-point severity scale ranging from 0 to 6, where 0 = least severe to 6 = extremely severe. Overall total score was calculated by taking the mean of the response of all individual 28 questions. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.|||scores on a scale||Standard Deviation|Mean
2601046|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Ocular Symptom Score|The reflective TOSS is defined as the sum of the participant-rated reflective symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Reflective TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.|||scores on a scale||Standard Deviation|Mean
2601047|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Individual Morning and Evening Reflective Total Nasal Symptom Score|The reflective TNSS is defined as the sum of the participant-rated reflective symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.|||scores on a scale||Standard Deviation|Mean
2601048|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Ocular Symptom Scores|The instantaneous TOSS is defined as the sum of the participant-rated instantaneous symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes at the time of evaluation. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Instantaneous TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.|||scores on a scale||Standard Deviation|Mean
2601049|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Ocular Symptom Scores (TOSS)|The reflective TOSS is defined as the sum of the participant-rated reflective symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). Reflective TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.|||scores on a scale||Standard Deviation|Mean
2601050|NCT02155881|Secondary|Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Instantaneous Total Nasal Symptom Scores|The instantaneous TNSS is defined as the sum of the participant-rated instantaneous symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion at the time of evaluation. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using LOCF.|||scores on a scale||Standard Deviation|Mean
2601051|NCT02155881|Primary|Change From Baseline Over 2 Weeks in Participant-Reported Morning and Evening Reflective Total Nasal Symptom Scores (TNSS)|The reflective TNSS is defined as the sum of the participant-rated reflective symptom scores for the 4 nasal symptoms of runny nose, itchy nose, sneezing, and nasal congestion over the past 12 hours. Each symptom was evaluated by the participant in an assessment diary, once in the morning (AM score) and after 12 hours in the evening (PM score) over 2 weeks of treatment period and was rated on a severity scale ranging from 0 to 3, where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe (symptom hard to tolerate, interferes with daily activities/sleeping). TNSS score ranges from 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. The baseline value was defined as the average score over the Day -6 to Day 0. Change from Baseline was thus calculated as the 2-week average score recorded from Day 1 up to Day 14 minus the Baseline score.|Baseline and Week 1 up to Week 2 (entire treatment period)|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had 1 baseline and at least 1 post-baseline value. Missing data was imputed using Last Observation Carried Forward (LOCF).|||scores on a scale||Standard Deviation|Mean
2601052|NCT02155738|Secondary|Interference of Pain With Physical, Mental and Social Activities|"Interference of pain with physical, mental and social activities will be measured by the Patient Reported Outcomes Measures Information Systems-Pain Interference-Short Form 8a (PROMIS PI-SF-8a) administered on POD#7.~This instrument measures the self reported consequences of pain on relevant aspects of one's life. This scale is considered to be universal rather than disease specific. Each question has five response options ranging in value from 1-5. The total raw score for the scale is the sum of all values. The total raw score can range from 8-40. All questions much be answered to obtain a valid score.~A higher PROMIS score indicates more 'hurt' or pain."|1 week|The number of participants analyzed is less than the total starting the study in each group; data is missing. Missing data indicates that the PROMIS PI-SF-8A was not received from the subject.|||units on a scale||Standard Deviation|Mean
2601053|NCT02155738|Primary|Cumulative Narcotic Consumption Over the First 24 Hours|Equianalgesic dosage tables will be used to convert intra- and postoperative narcotics into morphine equivalents to compare narcotic requirements for the first week after surgery. Higher numbers indicate higher narcotic usage.|First 24 hours||||mg||Standard Deviation|Mean
2601054|NCT02155738|Primary|Change From Baseline in Postoperative Pain|"VAS or Visual Analog Score is a quantitative measure, in this study, of pain that the subject is currently experiencing. The VAS is presented as a straight line which measures 100mm. The subject is instructed to mark an 'X' through this line reflecting the amount of pain that they are currently experiencing. Zero would indicate no pain, while '100' would indicate the most severe pain ever. Thus the total range for this scale would be 0-100 mm. Higher values indicate more pain; lower value indicate less pain.~For this outcome measure, the VAS scores from Baseline and the VAS scores from 24 hours after the end of surgery are being used. The change from baseline in postoperative pain equals the 24 hour VAS score minus the baseline VAS score.~The Change from Baseline would be the 24-hour VAS score minus the Baseline VAS score. Higher values indicate more pain; lower values indicate less pain."|24 hours|The number of participants analyzed is less than the total starting the study in each group; data is missing. Missing data indicates that a 24 hour VAS was not obtained from the subject.|||units on a scale||Standard Deviation|Mean
2601055|NCT02155712|Secondary|Compare Short Form-12 (SF-12) Scores Between Both Groups|The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ragning from 0-100. Low values represent a poor health state and high values represent a good health state.|2 years|||||||
2601056|NCT02155712|Secondary|Compare Oxford Knee Score (OKS) Scores Between Both Groups|The OKS questionnaire consists of 12 questions that cover function and pain of the knee. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.|2 years|||||||
2601091|NCT02155608|Secondary|Height|A dimensional measure assessed in centimeters (cm).|Change over baseline and weeks 1, 4, and 5.|Data missing for some visits.|||cm.||Standard Error|Least Squares Mean
2601059|NCT02155712|Primary|Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System|Success is defined as freedom from Triathlon Tritanium Tibial Baseplate revision for aseptic loosening.|2 years|The primary objective analysis only includes cementless, Cohort 1 participants. All Cohort 2 participants received cemented primary total knee replacements and are not included in the primary objective analysis.|||Successful Knees|Knees||Number
2601060|NCT02155660|Secondary|Immunogenicity of Benralizumab|Anti-drug antibody (ADA) responses such as ADA prevalence, ADA incidence, ADA persistently positive counts, etc. were presented.|Pre-treatment until end of follow-up, week 60 per protocol.|Safety analysis set. For each parameter, the number of subjects at risk is to be analyzed.|||Participants|||Count of Participants
2601061|NCT02155660|Secondary|Serum Concentration of Benralizumab|PK serum samples were collected pre-dose at each visit.|Pre-first dose and pre-dose at end of treatment (week 56).|PK analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2601062|NCT02155660|Secondary|Duration of Study Treatment Administration|Duration of study treatment is calculated from first dose date to last dose date + 1 day.|From first dose date to last dose date, 48 weeks per protocol.|Safety analysis set|||Days||Standard Deviation|Mean
2601063|NCT02155660|Secondary|Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL|Types of healthcare encounter: Hospitalisations (inc. intensive care and/or general care), Emergency department visits, Unscheduled outpatients visits, Home visits, Telephone calls, and ambulance transports.|Immediately following first IP dose up to Week 56|Full analysis set, baseline EOS>=220/uL|||Participants|||Count of Participants
2601064|NCT02155660|Secondary|Annual COPD Exacerbation Rate Associated With ER or Hospitalization Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL|Annual COPD exacerbations rate that result in ER or hospitalization is calculated by number of exacerbations resulting ER or hospitalization divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.|Immediately following the first IP dose through week 56|Full analysis set, baseline EOS>=220/uL|||Exacerbations per year||95% Confidence Interval|Least Squares Mean
2601065|NCT02155660|Secondary|Time to First COPD Exacerbation|Time to first COPD exacerbation is from the randomization date to the first occurrence of COPD exacerbation.|Immediately following IP dose to Week 56|Full analysis set, baseline EOS>=220/uL|||Days||95% Confidence Interval|Median
2601066|NCT02155660|Secondary|Number of Participants Having at Least 1 COPD Exacerbation for Patients With Baseline EOS>=220/uL|A COPD exacerbation is defined by symptomatic worsening COPD requiring systemic corticosteroids, antibiotics, or an inpatient hospitalization/death due to COPD.|Immediately following first IP dose up to week 56|Full analysis set, baseline EOS>=220/uL|||Participants|||Count of Participants
2601067|NCT02155660|Secondary|Annual EXACT-PRO Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL|"The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences today. The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Annual EXACT-PRO exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model."|Immediately following the first IP dose through week 56|Full analysis set, baseline EOS>=220/uL|||Exacerbations per year||95% Confidence Interval|Least Squares Mean
2601068|NCT02155660|Secondary|Duration of COPD Exacerbation Based on EXACT-PRO Score for Patients With Baseline EOS>=220/uL|"The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences today. The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. COPD exacerbation event frequency is identified by comparing the baseline score with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Event duration is calculated after identification of the following five parameters: 1) onset; 2) three-day rolling average; 3) maximum observed value; 4) threshold for improvement; and 5) recovery. That is, duration of the exacerbation is the time elapse between onset and recovery of the event."|Immediately following first IP up to week 56|Full analysis set, baseline EOS>=220/uL|||Days||Standard Deviation|Mean
2601069|NCT02155660|Secondary|Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL|"The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences today. The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Severity of the study is the highest score of EXACT-PRO."|Immediately following first IP up to week 56|Full analysis set, baseline EOS>=220/uL|||Score on a scale||Standard Deviation|Mean
2601070|NCT02155660|Secondary|Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL|"The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while considering their experiences today. The daily EXACT-PRO total score is recorded and has a range of 0-100 with higher scores indicative of greater severity. COPD exacerbation event frequency is calculated based on comparison of the baseline score with daily total scores. An increase of EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicates a COPD exacerbation event has occurred."|Immediately following first IP up to week 56|Full analysis set, EOS>=220/uL|||Participants|||Count of Participants
2601071|NCT02155660|Secondary|Mean Change From Baseline in Proportion of Nights With Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL|Change from baseline to Week 56 in proportion of nights with awakenings due to respiratory symptoms.|First IP up to Week 56|Full analysis set, baseline EOS>=220/uL|||Proportion of nights||Standard Deviation|Mean
2601072|NCT02155660|Secondary|Mean Change From Baseline in Total Rescue Medication Use (Number of Puffs Per Day) for Patients With Baseline EOS>=220/uL|The number of rescue medication inhalations and nebulizer treatments taken are recorded by the patient in the eDiary twice daily. Total rescue medication use is the sum of daytime and night-time use.|First IP up to Week 56|Full analysis set, baseline EOS>=220/uL|||Puffs/day||Standard Deviation|Mean
2601073|NCT02155660|Secondary|Mean Change From Baseline in E-RS: COPD Total Score for Patients With Baseline EOS>=220/uL|The E-RS: COPD is an 11-item PRO developed to evaluate the severity of respiratory symptoms of COPD. Summation of E-RS: COPD item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity.|First IP up to Week 56|Full analysis set, baseline EOS>=220/uL|||Score on a scale||Standard Deviation|Mean
2601074|NCT02155660|Secondary|Mean Change From Baseline in CAT Total Score for Patients With Baseline EOS>=220/uL|CAT is an 8-item PRO developed to measure the impact of COPD on health status. The instrument uses semantic differential six-point response scales. A CAT total score is the sum of item responses. Score ranges from 0 to 40 with higher scores indicative of greater COPD impact on health status.|First IP up to Week 56|Full analysis set, baseline EOS>=220/uL|||Score on a scale||Standard Deviation|Mean
2601075|NCT02155660|Secondary|Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL|SGRQ is from 50-item PRO instrument. The SGRQ total score is expressed as a percentage of overall impairment, in which 100% means the worst possible health status and 0 indicates the best possible health status.|First IP up to Week 56|Full analysis set, baseline EOS>=220/uL|||Percentage||Standard Deviation|Mean
2601076|NCT02155660|Secondary|Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL|Pre-bronchodilator FEV1 (L) is collected at Weeks 0, 4, 8, 16, 24, 32, 40, 48, and 56. Baseline is the last non-missing value with quality (acceptable or borderline quality grade) prior to the first dose of study treatment.|First IP up to end of treatment Week 56|Full analysis set, baseline EOS>=220/uL|||Liter||Standard Deviation|Mean
2601077|NCT02155660|Secondary|Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL|"A COPD exacerbation is defined by symptomatic worsening of COPD requiring:~Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or~Use of antibiotics; and/or~An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model."|Immediately following the first IP dose through week 56|Full analysis set, baseline EOS<220/uL|||Exacerbations per year||95% Confidence Interval|Least Squares Mean
2601078|NCT02155660|Primary|Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL|"A COPD exacerbation is defined by symptomatic worsening of COPD requiring:~Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or~Use of antibiotics; and/or~An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model."|Immediately following the first IP dose through week 56|Full analysis set, baseline EOS>=220/uL|||Exacerbations per year||95% Confidence Interval|Least Squares Mean
2601079|NCT02155608|Other Pre-specified|Children's Sleep Habits Questionnaire (CSHQ)|A parent completed 33-item scale to assess sleep related problems. Total scores range from 33 to 99 divided among 8 sub scales , with higher scores indicating more severe difficulties.|Weekly for double-blind trial.|||||||
2601080|NCT02155608|Other Pre-specified|Behavior Rating Inventory of Executive Functioning (BRIEF)|A parent completed rating of child executive function. Comprises 5 sub scales that measure various measures of behavior and cognition. Raw scores on each measure are converted to T scores ranging from 28 to 103, with higher scores indicating greater difficulties.|Baseline, end of Weeks 4 and 5.|||||||
2601081|NCT02155608|Other Pre-specified|Electroencephalography (EEG)|A laboratory measure of cortical activity.|Baseline and Week 4|||||||
2601082|NCT02155608|Other Pre-specified|Spatial Working Memory (SWM)|A computer-administered laboratory measure of executive function.|Baseline, Weeks 1 and 4|||||||
2601083|NCT02155608|Other Pre-specified|Attention Network Task (ANT) Response Inhibition|A computer-administered laboratory measure of executive function.|Baseline, Weeks 1 and 4|||||||
2601084|NCT02155608|Other Pre-specified|Affective Posner Task|A laboratory measure of frustration tolerance.|Baseline, and Weeks 1 and 4|||||||
2601085|NCT02155608|Secondary|Conners Global Index - Teacher|Teacher completed dimensional measure of ADHD symptoms, with scores ranging from 0-30, and higher scores indicating more severe symptoms.|Change over baseline and weeks 1, 2, 3, 4, 5.|Results may not be valid due to problems with data collection leading to substantial missing data.|||score on a scale||Standard Error|Least Squares Mean
2601086|NCT02155608|Secondary|Children's Depression Inventory (CDI)|A child completed self-report dimensional measure of depressive symptoms, with range of scores from 0 to 54. Higher scores reflect increasing depression. Cutoff scores < 17 to 20 are generally considered to be in the normative range. A score of 36 or higher reflects a relatively severe depression.|Change over baseline and weeks 4 and 5.|Data missing for some visits.|||score on a scale||Standard Error|Least Squares Mean
2601087|NCT02155608|Secondary|Pulse|Heart rate in beats per minute (bpm).|Change over baseline and weeks weeks 1, 4, and 5.|Data missing for some visits.|||bpm.||Standard Error|Least Squares Mean
2601088|NCT02155608|Secondary|Diastolic Blood Pressure|A dimensional measure assessed in mm mercury (Hg).|Change over baseline and weeks 1, 4, and 5.|Data missing for some visits.|||mm Hg.||Standard Error|Least Squares Mean
2601089|NCT02155608|Secondary|Systolic Blood Pressure|A dimensional measure expressed in mm mercury (Hg).|Change over baseline and weeks 1, 4, and 5.|Data missing from some visits.|||mm Hg.||Standard Error|Least Squares Mean
2601090|NCT02155608|Secondary|Weight|A dimensional measure assessed in kilograms (kg).|Change over baseline and weeks 1, 4, and 5.|Data missing for some visits.|||kg.||Standard Error|Least Squares Mean
2601092|NCT02155608|Secondary|Multidimensional Anxiety Scale for Children (MASC) - Parent Report|A parent completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity.|Change over baseline and weeks 4 and 5.|Data missing for some visits.|||score on a scale||Standard Error|Mean
2601093|NCT02155608|Secondary|Multidimensional Anxiety Scale for Children (MASC) - Child Report|A child completed rating of child anxiety, with scores ranging from 0-300, and higher scores indicating greater severity.|Change over baseline and weeks 4 and 5.|Data missing from some visits.|||score on a scale||Standard Error|Mean
2601094|NCT02155608|Secondary|Affective Reactivity Index (ARI) - Parent Report|A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.|Change over baseline and weeks 4 and 5.|Data missing for some visits.|||score on a scale||Standard Error|Mean
2601095|NCT02155608|Secondary|Affective Reactivity Index (ARI) - Child|A child completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.|Change over baseline and weeks 4 and 5.|Data missing for some visits|||score on a scale||Standard Error|Mean
2601096|NCT02155608|Secondary|Conners Global Index - Parent Report|Parent completed dimensional measure of ADHD symptoms, with score range from 0- 30, and higher scores indicating more severe symptoms.|Change over baseline and weeks 1, 2, 3, 4, 5.|Data missing for some visits.|||score on a scale||Standard Error|Mean
2601097|NCT02155608|Secondary|Clinical Global Impression - Improvement (CGI-I)|"Categorical measure indicating degree improved or not improved compared with baseline for each treatment group. Minimum score = 1 (very much improved); Maximum score = 7 (very much worse). Results reflect number of participants stratified as Improved (CGI-I <=2) or Not Improved (CGI-I > 2)."|Change over weeks 1, 2, 3, 4, and 5 compared with baseline.|Data missing for some visits.|||Participants|||Count of Participants
2601098|NCT02155608|Primary|ADHD-IV Rating Scale (ADHD-RS)|A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity.|Change over baseline and weeks 1, 2, 3, 4 and 5.|Data missing for some visits.|||score on a scale||Standard Error|Least Squares Mean
2601099|NCT02155543|Primary|Maximal Plasma Concentration (Cmax) of AGN-223575|Concentrations of AGN-223575 were measured in the plasma (the liquid component of the blood in which the blood cells are suspended) in samples collected up to 24 hours post-dose. The Cmax is reported.|Day 15|Pharmacokinetic Population: AGN-223575-treated subjects in cohorts with pharmacokinetic samples (i.e., Cohorts 2 to 5)|||Nanograms/Milliliters (ng/mL)||Standard Deviation|Mean
2601100|NCT02155465|Secondary|Progression-free Survival||2 years|Participants response to study treatment were combined and evaluated to determine an overall progression-free survival.|||months||95% Confidence Interval|Median
2601101|NCT02155465|Secondary|Number of Participants With NCI CTCAE Toxicity|Toxicity grading will be performed in accordance with NCI CTCAE, version 4.0.|2 years||||Participants|||Count of Participants
2601102|NCT02155465|Primary|Assess Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), at least a 20% increase in the sum of the diameter of the target lesions or the appearance of one or more new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD|1 year|Participants response to study treatment were combined and evaluated to determine an overall response rate.|||% of participants with partial response||95% Confidence Interval|Number
2601103|NCT02155465|Primary|Maximally Tolerated Dose (MTD) (Phase I)||1 year|Maximally Tolerated Dose (MTD) is determined by evaluating all Phase I participants as a whole. All Phase I participants are evaluated together to determine the MTD.|||mg|||Number
2601104|NCT02155335|Primary|Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (2 Weeks Post Injections)|Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant than is administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants completed a questionnaire 2 weeks after the injections in which they indicated if they preferred the syringe, the Smartject or were undecided as to which they preferred.|Day 14 (2 weeks post injections)|All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire|||Percentage of Participants|||Number
2601105|NCT02155335|Primary|Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or Are Undecided (Day of Injections)|Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant is then administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Following the completion of the last injection, the participants completed a questionnaire in which they indicated if they preferred the syringe, the Smartject or were undecided as to which they preferred.|Day 0 (post last injection)|All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire|||Percentage of Participants|||Number
2601106|NCT02155322|Primary|Percentage of Participants Discontinuing Study Drug Because of AEs|An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose to last dose of treatment; up to 12 months|All participants who received at least one dose of study drug.|||Percentage of participants|||Number
2601107|NCT02155322|Primary|Percentage of Participants Experiencing Adverse Events (AEs)|An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose through follow-up; up to 13 months|All participants who received at least one dose of study drug.|||Percentage of participants|||Number
2601643|NCT02150954|Secondary|Time to Active Labor|Active labor was defined as the presence of regular, painful contractions and a minimum of 2 cm cervical dilation and complete effacement in nulliparous women or a minimum of 4 cm cervical dilation in multiparous women.|during admission for delivery, up to approximately 4 days||||hours||Inter-Quartile Range|Median
2601108|NCT02155309|Primary|Efficacy: Number of Head Movements During Rotation|During rotation, efficacy is measured by the number of head movements subjects are able to make (12 per minute). While seated yaw-axis rotating, a pre-recorded computerized voice informed subjects to make paced head tilts of 30 ̊ to the right and left at a rate of 0.125 Hz (right, center, left, and back to center over 16 seconds).|40 min||||Number of head tilts||Standard Deviation|Mean
2601109|NCT02155283|Other Pre-specified|Change in Amount of Pain Determined by the NRS at the 1-week Follow-up After the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)|Pain level will be scored by the subject using the NRS on a 0 to 10 scale where 10 represents the highest level of pain and 0 represents no pain.|4 weeks||||units on a scale||Standard Deviation|Mean
2601110|NCT02155283|Secondary|Change in Heart Rate Variability (and the Autonomic System)|"Gather information regarding:~Autonomic nervous system activity by measuring heart rate variability (HRV)."|3 weeks, 4 weeks|||||||
2601111|NCT02155283|Secondary|Change in Symmetry of Muscle Function on Either Side of the Spine|"Gather information regarding:~Symmetry of muscle function about the spine using static surface electromyography (SEMG)"|3 weeks, 4 weeks|||||||
2601112|NCT02155283|Secondary|Change in Functional Health Status by ODI|Functional health status will be determined by the ODI questionnaire completed by the subject (based upon answers from 10 multiple choice questions)|3 weeks, 4 weeks|||||||
2601113|NCT02155283|Secondary|Change in Proprioception and Vestibular Function.|"Gather information regarding:~Balance and Fall Prevention using digital posturography"|3 weeks, 4 weeks|||||||
2601114|NCT02155283|Primary|Change in Amount of Pain Determined by the NRS at the End of the 3-week Treatment Plan Compared to Baseline (Before Treatment)|Pain level will be scored by the subject using the NRS on a 0 to 10 scale where 10 represents the highest level of pain and 0 represents no pain.|3 weeks|Completers per protocol|||units on a scale||Standard Deviation|Mean
2601115|NCT02155257|Primary|Cognitive Style|Cognitive style determined for each individual by subtracting the score in the Pain Catastrophizing Scale (CATS) questionnaire (with a score range of 0-52 with higher score showing more catastrophizing) from the Life Orientation Test Revised (LOT-R) questionnaire (score range of 0-24, with a higher score denoting a better outcome). Thus, the total score could range from ranges from -52 to 24, with lower scores indicating worse cognitive style related to pain reporting and higher scores indicating better cognitive style related to pain reporting. There are no subscales here.|baseline||||score on a scale||Standard Deviation|Mean
2601116|NCT02155257|Primary|Pain Intensity Rating|Pain is reported verbally after each stimulus by the subject on a scale of 0 (no pain) to 10 (worst imagineable pain). For each individual the value used is the average of all presentations of the 50 degree stimulus.|Reported 5 seconds after each stimulus||||units on a scale||Standard Deviation|Mean
2601117|NCT02155257|Primary|Resting Pupil Diameter|Resting pupil diameter will be measured using an infrared camera to obtain baseline measurements 2 hours after dosing subject pupil diameter measurements will be repeated|Baseline and 2 hours||||mm||Standard Deviation|Mean
2601118|NCT02155101|Other Pre-specified|HIV-1 RNA Viral Load|"Percentage of subjects who have plasma HIV-1 RNA levels <50 cps/ml after 24 weeks of follow-up following a switch to DRV/r monotherapy versus continuing triple therapy containing 2 NRTIs + LPV/r (or ATV/r), using the FDA Time to Loss of Virologic Response method. The FDA 'Snapshot' algorithm evaluates HIV RNA response using only the results at the week 24 time-point which also means that rebound at earlier time-points are not classified as treatment failure, unless it lead to discontinuation prior to the week 48."|24 weeks||||Participants|||Count of Participants
2601119|NCT02155101|Secondary|HIV-1 RNA Viral Load|"Percentage of subjects who have plasma HIV-1 RNA levels <50 cps/ml after 12 weeks of follow-up following a switch to DRV/r monotherapy versus continuing triple therapy containing 2 NRTIs + LPV/r (or ATV/r), using the FDA Time to Loss of Virologic Response method. The FDA 'Snapshot' algorithm evaluates HIV RNA response using only the results at the week 12 time-point which also means that rebound at earlier time-points are not classified as treatment failure, unless it lead to discontinuation prior to the week 48."|12 weeks||||Participants|||Count of Participants
2601120|NCT02155101|Primary|HIV-1 RNA Viral Load|Percentage of subjects who have plasma HIV-1 RNA levels <400 cps/ml after 24 weeks of follow-up following a switch to DRV/r monotherapy versus continuing triple therapy containing 2 NRTIs + LPV/r (or ATV/r) (FDA Snapshot method). The FDA 'Snapshot' algorithm evaluates HIV RNA response using only the results at the week 24 time-point which also means that rebound at earlier time-points are not classified as treatment failure, unless it lead to discontinuation prior to the week 48.|24 weeks||||Participants|||Count of Participants
2601121|NCT02155010|Secondary|Patient's Anxiety|We compared patient's anxiety using spielberger's state-trait anxiety inventory before and after surgery. This consists of two self-evaluation scales designed to assess state-anxiety and trait-anxiety. Each scale contains 20 items, each of which is rated from 1 to 4. Clinically significant levels of state or trait-anxiety were defined as scores >50 on the state- or trait-anxiety scale. State or trait-anxiety inventory's minimal score is 20 and maximal score is 80. We analyzed State Anxiety Inventory scale before and after surgery.|up to 3 days||||points||Standard Deviation|Mean
2601122|NCT02155010|Primary|Incidence of Hypotension|We compare incidence rate of hypotension during infusion of dexmedetomidine|up to 3 hours||||participants|||Number
2601123|NCT02154906|Secondary|Change in Radiographic Bone Level|measurement of radiographic bone level at the time of surgical intervention will be compared with measurement of bone level 6 months after surgery|baseline and 6 months after surgery||||mm||Standard Deviation|Mean
2601124|NCT02154906|Primary|Change in Clinical Attachment Level (CAL)|measurement of CAL at the time of surgical intervention will be compared with measurement of CAL and bone level 6 months after surgery|baseline and 6 months after surgery||||mm||Standard Deviation|Mean
2601137|NCT02154763|Secondary|4-12 h Postoperative Ketorolac Consumption|The amount in mg of Ketorolac administered to patient|4-12 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601644|NCT02150954|Secondary|Rate of Cesarean Delivery|Number of participants having a cesarean delivery|during admission for delivery, up to approximately 4 days||||participants|||Number
2601125|NCT02154763|Secondary|6 Minute Walking Distance Post Operative Day 7-10 (POD 7-10)|6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome)|Post operative day 7-10 (Follow-up Clinic)|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Missing Appointment or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||meters||Standard Deviation|Mean
2601126|NCT02154763|Secondary|Postoperative Day 7-10 Quality of Recovery Questionnaire (QR-40)|"40-item questionnaire provides a global score(Minimum-score 40,Maximum-Score 200, Higher score represent better Quality of recovery of participant in both global and subscores) subscores(summed to total the global score) across five dimensions explained below, in all categories minimum score is 1,maximum score of 5 for each question.unit is scores on a scale for all questions.~Emotional_State:9 questions subscore can range between 9-45 Physical_Comfort:12 questions, subscore range between 12-60 Psychological Support:7 questions, subscore range between 7-35 Physical_Independence:5 questions, subscore range between 5-25 Pain:7 questions,subscore range between 5-25~Questionnaire has two parts A and B, In part A, a score of 1 represents the answer of None of the time (Poor)and 5 represents the answerAll of the time (Excellent)Part B, score of 1 represents the answerAll of the time (Excellent) and 5 representsNone of the time (Poor)"|Post operative day 7-10|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||Scores on a scale||Standard Deviation|Mean
2601127|NCT02154763|Secondary|24-48 h Postoperative Dilaudid Consumption|The amount in mg of Dilaudid administered to patient|24-48 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601128|NCT02154763|Secondary|24-48 h Postoperative Tramadol Consumption|The amount in mg of Tramadol administered to patient|24-48 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601129|NCT02154763|Secondary|24-48 h Postoperative Ketorolac Consumption|The amount in mg of Ketorolac administered to patient|24-48 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601130|NCT02154763|Secondary|24-48 h Postoperative Tylenol Consumption|The amount in mg of Tylenol administered to patient|24-48 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Median
2601131|NCT02154763|Secondary|12-24 h Postoperative Dilaudid Consumption|The amount in mg of Dilaudid administered to patient|12-24 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601132|NCT02154763|Secondary|12-24 h Postoperative Tramadol Consumption|The amount in mg of Tramadol administered to patient|12-24 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601133|NCT02154763|Secondary|12-24 h Postoperative Ketorolac Consumption|The amount in mg of Ketorolac administered to patient|12-24 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601134|NCT02154763|Secondary|12-24 h Postoperative Tylenol Consumption|The amount in mg of Tylenol administered to patient|12-24 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601135|NCT02154763|Secondary|4-12 h Postoperative Dilaudid Consumption|The amount in mg of Dilaudid administered to patient|4-12 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601136|NCT02154763|Secondary|4-12 h Postoperative Tramadol Consumption|The amount in mg of Tramadol administered to patient|4-12 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601645|NCT02150954|Primary|Time to Delivery|Time from foley balloon placement until neonate delivery|foley bulb placement until delivery (during admission for delivery, up to approximately 4 days)||||hours||Inter-Quartile Range|Median
2601138|NCT02154763|Secondary|4-12 h Postoperative Tylenol Consumption|The amount in mg of Tylenol administered to patient|4-12 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601139|NCT02154763|Secondary|2-4 h Postoperative Fentanyl Consumption|The amount in mcg of Fentanyl administered to patient|2-4 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mcg||Standard Deviation|Mean
2601140|NCT02154763|Secondary|2-4 h Postoperative Tramadol Consumption|The amount in mg of Tramadol administered to patient|2-4 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601141|NCT02154763|Secondary|2-4 h Postoperative Dilaudid Consumption|The amount in mg of Dilaudid administered to patient|2-4 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601142|NCT02154763|Secondary|2-4 h Postoperative Ketorolac Consumption|The amount in mg of Ketorolac administered to patient|2-4 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601143|NCT02154763|Secondary|2-4 h Postoperative Tylenol Consumption|The amount in mg of Tylenol administered to patient|2-4 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601144|NCT02154763|Secondary|1-2 h Postoperative Fentanyl Consumption|The amount in mcg of Fentanyl administered to patient|1-2 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mcg||Standard Deviation|Mean
2601145|NCT02154763|Secondary|1-2 h Postoperative Tramadol Consumption|The amount in mg of Tramadol administered to patient|1-2 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601146|NCT02154763|Secondary|1-2 h Postoperative Dilaudid Consumption|The amount in mg of Dilaudid administered to patient|1-2 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601147|NCT02154763|Secondary|1-2 h Postoperative Ketorolac Consumption|The amount in mg of Ketorolac administered to patient|1-2 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601148|NCT02154763|Secondary|1-2 h Postoperative Tylenol Consumption|The amount in mg of Tylenol administered to patient|1-2 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601149|NCT02154763|Secondary|0-1 h Postoperative Fentanyl Consumption|The amount in mcg of Fentanyl administered to patient|0-1 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mcg||Standard Deviation|Mean
2601150|NCT02154763|Secondary|0-1 h Postoperative Tramadol Consumption|The amount in mg of Tramadol administered to patient|0-1 h Postoperative Tramadol consumption|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601151|NCT02154763|Secondary|0-1 h Postoperative Dilaudid Consumption|The amount in mg of Dilaudid administered to patient|0-1 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601152|NCT02154763|Secondary|0-1 h Postoperative Ketorolac Consumption|The amount in mg of Ketorolac administered to patient|0-1 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601726|NCT02150837|Secondary|Fat Mass|Fat mass expressed as an absolute change from baseline.|12 weeks|Not all subjects remaining at 12 weeks had body composition testing performed.|||Pounds||Standard Deviation|Mean
2601153|NCT02154763|Secondary|0-1 h Postoperative Tylenol Consumption|The amount in mg of Tylenol administered to the patient|0-1 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||mg||Standard Deviation|Mean
2601154|NCT02154763|Secondary|Postoperative Day 1 Quality of Recovery Questionnaire (QR-40)|"40-item questionnaire provides a global score(Minimum-score 40, Maximum-Score 200, Higher score represent better Quality of recovery of participant in both global and subscores) subscores(summed to total the global score) across five dimensions explained below, in all categories minimum score is 1, maximum score of 5 for each question.unit is scores on a scale for all questions.~Emotional_State:9 questions subscore can range between 9-45 Physical_Comfort:12 questions, subscore range between 12-60 Psychological Support:7 questions, subscore range between 7-35 Physical_Independence:5 questions, subscore range between 5-25 Pain:7 questions, subscore range between 5-25~Questionnaire has two parts A and B, In part A, a score of 1 represents the answer of None of the time (Poor)and 5 represents the answerAll of the time (Excellent)Part B, score of 1 represents the answerAll of the time (Excellent) and 5 representsNone of the time (Poor)"|Post operative day 1|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||Scores on a scale||Standard Deviation|Mean
2601155|NCT02154763|Secondary|6 Minute Walking Distance Post Operative Day 2 (POD2)|6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome)|Post operative day 2|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||Meters||Standard Deviation|Mean
2601156|NCT02154763|Secondary|6 Minute Walking Distance Post Operative Day 1 (POD1)|6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome)|Post operative day 1|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||Meters||Standard Deviation|Mean
2601157|NCT02154763|Secondary|48h Peak Expiratory Flow (PEF) Score|Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.|48 hours post operatively|Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.|||L/min||Standard Deviation|Mean
2601158|NCT02154763|Secondary|40h Peak Expiratory Flow (PEF) Score|Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.|40 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||L/min||Standard Deviation|Mean
2601159|NCT02154763|Secondary|32h Peak Expiratory Flow (PEF) Score|Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.|32 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||L/min||Standard Deviation|Mean
2601160|NCT02154763|Secondary|24h Peak Expiratory Flow (PEF) Score|Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.|24 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||L/min||Standard Deviation|Mean
2601161|NCT02154763|Secondary|20h Peak Expiratory Flow (PEF) Score|Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.|20 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||L/min||Standard Deviation|Mean
2601202|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 2|Mature breast milk samples were collected on Day 2 of the Sampling Period for all subjects.|Day 2|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||µg/mL||Full Range|Median
2601162|NCT02154763|Secondary|16h Peak Expiratory Flow (PEF) Score|Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.|16 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||L/min||Standard Deviation|Mean
2601163|NCT02154763|Secondary|12h Peak Expiratory Flow (PEF) Score|Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.|12 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||L/min||Standard Deviation|Mean
2601164|NCT02154763|Secondary|8h Peak Expiratory Flow (PEF) Score|Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.|8 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||L/min||Standard Deviation|Mean
2601165|NCT02154763|Secondary|4h Peak Expiratory Flow (PEF) Score|Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.|4 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||L/min||Standard Deviation|Mean
2601166|NCT02154763|Secondary|2h Peak Expiratory Flow (PEF) Score|Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.|2 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||L/min||Standard Deviation|Mean
2601167|NCT02154763|Secondary|1h Peak Expiratory Flow (PEF) Score|Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.|1 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||L/min||Standard Deviation|Mean
2601168|NCT02154763|Primary|40-48 Hours Post Operative Pain Level|Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).|40-48 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients being discharged from hospital early or refusing reading; varying the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||units on a scale||Standard Deviation|Mean
2601169|NCT02154763|Primary|32-40 Hours Post Operative Pain Level|Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).|32-40 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients being discharged from hospital early or refusing reading; varying the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||units on a scale||Standard Deviation|Mean
2601170|NCT02154763|Primary|24-32 Hours Post Operative Pain Level|Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).|24-32 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients being discharged from hospital early or refusing reading; varying the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||units on a scale||Standard Deviation|Mean
2601171|NCT02154763|Primary|20-24 Hours Post Operative Pain Level|Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).|20-24 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||units on a scale||Standard Deviation|Mean
2601172|NCT02154763|Primary|16-20 Hours Post Operative Pain Level|Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).|16-20 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||units on a scale||Standard Deviation|Mean
2601727|NCT02150837|Secondary|Lean Mass|Lean mass expressed as an absolute change from baseline.|12 weeks|Not all subjects remaining at 12 weeks had body composition testing performed.|||Pounds||Standard Deviation|Mean
2601173|NCT02154763|Primary|12-16 Hours Post Operative Pain Level|Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).|12-16 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||units on a scale||Standard Deviation|Mean
2601174|NCT02154763|Primary|8-12 Hours Post Operative Pain Level|Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).|8-12 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||units on a scale||Standard Deviation|Mean
2601175|NCT02154763|Primary|4-8 Hours Post Operative Pain Level|Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).|4-8 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||units on a scale||Standard Deviation|Mean
2601176|NCT02154763|Primary|2-4 Hours Post Operative Pain Level|Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).|2-4 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||units on a scale||Standard Deviation|Mean
2601177|NCT02154763|Primary|1-2 h Postoperative Pain Level|Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).|1-2 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||units on a scale||Standard Deviation|Mean
2601178|NCT02154763|Primary|0-1 h Postoperative Pain Level|Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).|0-1 hours post operatively|"Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame.~The analysis was done and revised by our Statistician"|||units on a scale||Standard Deviation|Mean
2601179|NCT02154581|Secondary|Radiographic Bone Level|Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at baseline 3, and 12 months after crown delivery. Radiographic bone measurements recorded following final restoration placement (baseline), after 3 and 12 months of loading, and change between these time points. A positive value indicates bone loss and a negative value indicates bone gain. BIC (Bone implant contact)= Distance from implant shoulder to first bone to implant contact.|Up to 1 year after baseline||||mm||Standard Deviation|Mean
2601180|NCT02154581|Secondary|Modified Bleeding Index|Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 3, 6, 12 months after crown delivery. Bleeding from the gums is measured on probing the gum and measured on scale of 0 to 5, with 0 being the best outcome, with no bleeding, and 5 being the worst outcome, with spontaneous bleeding. The scores are totaled and a mean score reported.|Up to 1 year after baseline||||units on a scale||Standard Deviation|Mean
2601181|NCT02154581|Secondary|Modified Plaque Index|Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 3, 6, 12 months after crown delivery. Measurement of amount of plaque build-up on teeth, using a scale of 0 (no plaque detection), to 3 (an abundance of soft matter). The scores are totaled and a mean score reported.|Up to 1 year after baseline||||score on a scale||Standard Deviation|Mean
2601182|NCT02154581|Secondary|Probing Depth|Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at baseline, 3 and 12 months after crown delivery. The measurement of the pocket around the implanted tooth, measured with a graduated probe. A healthy pocket depth is around 3 mm with no bleeding during the measurement process. The values are totaled and a mean score of all the readings is reported.|Up to 1 year after baseline||||mm||Standard Deviation|Mean
2601183|NCT02154581|Secondary|PES/WES (Pink Esthetic Score, White Esthetic Score).|Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 12 months after crown delivery. The PES (Pink Esthetic Score) and WES (White Esthetic Score) scales are 10 point scales, made up of 5 categories, each with a 2 point value. Each category is scored out of 2, and the scores totaled to give an optimal score out of 10, and then the two scores (PES and WES) added to give a total score out of 20, with 20 being the highest possible score (best outcome) and 0 being the worst outcome.|Approximately 1 year after baseline||||score on a scale||Standard Deviation|Mean
2601184|NCT02154581|Primary|Mid Facial Mucosal Level at Implant Site|Baseline will be at the time of crown delivery. Thereafter, the mid facial mucosal level at implant site will be recorded at 3, 6, 12 months after crown delivery.|Change from Baseline to 3 months||||mm||Standard Deviation|Mean
2601185|NCT02154477|Primary|LH|Luteinizing hormone (LH) concentrations after intranasal insulin as compared to placebo (intranasal saline). This endpoint was measured in both arms|4 hours|diabetes|||IU/L||Standard Deviation|Mean
2601315|NCT02153489|Other Pre-specified|Change From Baseline in Apnea-hypopnea Index (AHI) Per Hour of Total Sleep Time|The Apnea Hypopnea Index (AHI) is used to indicate the severity of obstructive sleep apnea. The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep|Week 3 of treatment||||Events/hr||Standard Error|Least Squares Mean
2601186|NCT02154425|Primary|The Average Daily Infant Dose of Certolizumab Pegol (CZP) Over the Dosing Interval (14 or 28 Days)|Mature breast milk samples will be collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 or on Day 28 of the Sampling Period for all subjects.|From Day 0 to Day 14 or 28|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||mg/kg/day||Full Range|Median
2601187|NCT02154425|Primary|The Calculated Infant Daily Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 28|In subjects receiving CZP 400 mg Q4W, a mature breast milk sample was collected on or about Day 28, prior to the next scheduled administration of CZP.|Day 28|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable. Measurement on day 28 applies to subjects on a CZP 400mg Q4W dosing regimen only.|||mg/kg/day||Full Range|Median
2601188|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast on Day 14|Mature breast milk samples was collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.|Day 14|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||mg/kg/day||Full Range|Median
2601189|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 12|Mature breast milk samples was collected on Day 12 of the Sampling Period for all subjects.|Day 12|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||mg/kg/day||Full Range|Median
2601190|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 10|Mature breast milk samples was collected on Day 10 of the Sampling Period for all subjects.|Day 10|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||mg/kg/day||Full Range|Median
2601191|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 8|Mature breast milk samples was collected on Day 8 of the Sampling Period for all subjects.|Day 8|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||mg/kg/day||Full Range|Median
2601192|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 6|Mature breast milk samples was collected on Day 6 of the Sampling Period for all subjects.|Day 6|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||mg/kg/day||Full Range|Median
2601193|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 4|Mature breast milk samples was collected on Day 4 of the Sampling Period for all subjects.|Day 4|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||mg/kg/day||Full Range|Median
2601194|NCT02154425|Primary|The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 2|Mature breast milk samples was collected on Day 2 of the Sampling Period for all subjects.|Day 2|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||mg/kg/day||Full Range|Median
2601195|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 28|In subjects receiving CZP 400 mg Q4W, a mature breast milk sample were collected on or about Day 28, prior to the next scheduled administration of CZP.|Day 28|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||µg/mL||Full Range|Median
2601196|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 14|Mature breast milk samples were collected (predose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.|Day 14|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||µg/mL||Full Range|Mean
2601197|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 12|Mature breast milk samples were collected on Day 12 of the Sampling Period for all subjects.|Day 12|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||µg/mL||Full Range|Median
2601198|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 10|Mature breast milk samples were collected on Day 10 of the Sampling Period for all subjects.|Day 10|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||µg/mL||Full Range|Median
2601199|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 8|Mature breast milk samples were collected on Day 8 of the Sampling Period for all subjects.|Day 8|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||µg/mL||Full Range|Median
2601200|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 6|Mature breast milk samples were collected on Day 6 of the Sampling Period for all subjects.|Day 6|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||µg/mL||Full Range|Median
2601201|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 4|Mature breast milk samples were collected on Day 4 of the Sampling Period for all subjects.|Day 4|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||µg/mL||Full Range|Median
2601203|NCT02154425|Primary|The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 0|Mature breast milk samples were collected predose on Day 0 of the Sampling Period (CZP dosing day) for all subjects.|Day 0|The Pharmacokinetic Per-Protocol Set (PK-PPS) consisted of all subjects with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.|||µg/mL||Full Range|Median
2601204|NCT02154386|Secondary|Change in Buccal Ridge Height|Ridge height measured at time of tooth extraction and grafting and again at time of implant placement. Changes in ridge height are determined (negative number signifies loss of ridge height)|at time of implant placement at 8-10 or 18-20 weeks following tooth extraction and grafting||||change in bone height (mm)||Standard Deviation|Mean
2601205|NCT02154386|Secondary|Change in Ridge Width|Ridge width measured at time of tooth extraction and grafting and again at time of implant placement. Changes in ridge width are determined (negative number signifies loss of ridge width)|at time of implant placement at 8-10 or 18-20 weeks following tooth extraction and grafting||||ridge width change (mm)||Standard Deviation|Mean
2601206|NCT02154386|Primary|Percent New Vital Bone Formation|Bone core biopsy will be evaluated histologically for percent new vital bone formation|after removal of bone core from site of dental implant placement at 18-20 weeks following tooth extraction and grafting||||percentage of vital bone||Standard Deviation|Mean
2601207|NCT02154347|Primary|Change From Baseline in HbA1c||16 weeks|full analysis set|||% (value of HbA1c)||Standard Deviation|Mean
2601208|NCT02154243|Secondary|Length of Stay||Length of the hospital stay (average of 4 days)|DATA WAS NOT COLLECTED. STUDY TERMINATED EARLY.||||||
2601209|NCT02154243|Primary|Change in Orthostatic Hypotension Questionnaire Score||From baseline assessment to post-intervention (30 min, 1 hr, 2 hrs, 3 hrs, 4 hrs)|DATA WAS NOT COLLECTED. STUDY TERMINATED EARLY.||||||
2601210|NCT02154139|Secondary|Percentage of Participants With Recurrence-free Survival Who Were Treated With the Drug as Adjuvant Therapy|Recurrence-free survival was determined in participants who were treated with the drug as adjuvant therapy, and tabulated, based on the date recurrence is confirmed, the presence or absence of recurrence, continued survival or death, and the date of death.|Baseline up to 96 weeks|The efficacy assessment population was defined as participants with advanced or recurrent breast cancer whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants||95% Confidence Interval|Number
2601211|NCT02154139|Secondary|Percentage of Participants With Progression Free Survival|Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.|Baseline up to 96 weeks|The efficacy assessment population was defined as participants with advanced or recurrent breast cancer whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants||95% Confidence Interval|Number
2601212|NCT02154139|Secondary|Percentage of Participants With Advanced or Recurrent Breast Cancer (Best Response)|Best overall response for a participant is the best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria. Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions greater than or equal to (>=) 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of >= 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.|Week 24, 48,96|The efficacy assessment population was defined as participants with advanced or recurrent breast cancer whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants||95% Confidence Interval|Number
2601213|NCT02154139|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The event occurred was breast cancer female|Baseline up to 96 weeks|Safety analysis set was defined as participants who were enrolled and completed the study.|||participants|||Number
2601214|NCT02154139|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 96 weeks|Safety analysis set was defined as participants who were enrolled and completed the study.|||participants|||Number
2601215|NCT02154087|Primary|Determine Change From Baseline in Cell Numbers in Subjects With VLU Following the First Dose of HP802-247|The following mediators were to be measured for the chronic ulcer stage: IL-1β, IL-6, TNF-α, IFN, MMP-2, and MMP-9, and the following for the resolving ulcer stage: PGE-2, Lipoxin, GM-CSF, TGFβ, IL-10, LL-37, Indoleamine 2,3-Dioxygenase (IDO), and Arginase (ARG-1). Each of the soluble mediators were to be plotted versus measurement time point [i.e., (pre-study run-in visit (RV)1), baseline (RV3), study visit (SV)2, and SV3]) and by subjects' quartile of percent reduction (%) in target wound area at SV3 from baseline (RV3).|Wound fluid samples were to be collected one week after the initial dose of HP802-247.|Due to the failure of HP802-247-09-029 to show superiority over its vehicle in study 802-247-09-029, this study was terminated after enrollment of one of the proposed 25 subjects. No data was collected.||||||
2620696|NCT01953328|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2601216|NCT02154061|Primary|Number of Participants With Four Fold Rise in HAI Titers or HAI 1:40 and Above in Each Group at D30|Number of participants with four fold rise in HAI titers or HAI 1:40 and above in each group at D30 will be recorded based on immunologic testing of blood samples|At day 30|"The Overall Number of Participants analyzed for IIV Flu Vaccine with Antibiotics is 15, as one participant received antibiotics and did not receive vaccine. The study personnel were unable to draw blood on her at the vaccination day- therefore she was part of the safety population and not the immunogenicity population."|||Participants|||Count of Participants
2601217|NCT02154048|Primary|Time to First Analgesic Dose||48 hours|one subject in the Local Anesthetic (LA) Control Group was not analyzed because subject did not return the data sheet|||hours||Standard Deviation|Mean
2601218|NCT02153983|Secondary|Changes in C-reactive Protein|Change (3 month minus minus baseline) in High-Sensitivity C-reactive protein concentrations using intent-to-treat. Higher values represent a worse outcome. There are no data from the evaluation-only participants, since they were not followed longitudinally.|Baseline to 3 months|Patients randomized to colchicine or placebo for randomized controlled trial, but only open-label colchicine for patients with type 2 diabetes|||mg/L||95% Confidence Interval|Mean
2601219|NCT02153983|Secondary|Change in HOMA-IR Index|Change (3 month minus minus baseline) in calculated homeostasis model of insulin sensitivity, calculated from derived from fasting glucose and insulin values = fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5) using intent-to-treat. Higher values represent a worse outcome. There are no data from the evaluation-only participants, since they were not followed longitudinally.|Baseline to 3 months|RCT has colchicine and placebo groups, open label is colchicine only.|||units on a scale||95% Confidence Interval|Mean
2601220|NCT02153983|Primary|Change in Insulin Sensitivity From FSIVGTT|Change (3 month minus minus baseline) in insulin sensitivity value, calculated from frequently-sampled intravenous glucose tolerance tests by Bergman's Minimal Model using intent-to-treat. Higher values represent a better outcome. There are no data from the evaluation-only participants, since they were not followed longitudinally.|Baseline to 3 months|Randomized trial has 2 groups, open label only one group|||10^-5*min^-1*mU^-1*mL||95% Confidence Interval|Mean
2601221|NCT02153918|Secondary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 33 months and 5 days||||Participants|||Count of Participants
2601222|NCT02153918|Secondary|Magnetic Resonance Imaging (MRI) Changes Secondary to Vaccination|MRI of the prostate was performed for changes in imaging characteristics of prostate cancer pre and post vaccination. MRI changes secondary to vaccination is defined as increase or decrease in the size of lesions from baseline (pre-vaccine) measurements.|Baseline (pre vaccination) and approximately week 10|3 subjects did not have week 10 MRI performed.|||cm||Standard Deviation|Mean
2601223|NCT02153918|Secondary|Prostatic Specific Antigen (PSA) Changes Secondary to Vaccination|A change in PSA secondary to vaccination is defined as an increase or decrease in PSA value beyond the baseline level. PSA levels of 4.0 ng/ml and lower are considered normal.|Baseline (pre vaccination) and approximately week 10|One subject came off-study prior to radical prostatectomy.|||ng/mL||Standard Deviation|Mean
2601224|NCT02153918|Secondary|Intraprostatic Treg Cell Infiltration With Cluster of Differentiation 4 (CD4)+Forkhead Box P3 (FOX-P3) Staining|Prostate biopsy samples collected at baseline and at surgery after last dose of vaccine will be stained for analysis of immune cell infiltrate. Quantification will be reported as number of stained cells per micron squared of surface area.|Baseline (pre vaccination) and post surgery after last dose of vaccine, approximately week 10|Only 26 subjects had available tissue for analysis.|||Cell/mm(2)||Standard Deviation|Mean
2601225|NCT02153918|Secondary|Count of Participants With Change in Peripheral Prostatic Specific Antigen (PSA)-Specific T Cell Responses|Change in peripheral prostatic specific antigen (PSA)-specific T cells will be assessed by the enzyme-linked immunospot (ELISPOT) assay. A change of >250 cluster of differentiation 4 (CD4) or cluster of differentiation 8 (CD8) cells producing cytokine or positive for cluster of differentiation 107a (CD107a) in response to PSA post vaccination relative to baseline will be considered evidence of an immunologic response to the vaccine. The number of subjects developing positive PSA-Specific T cell responses with vaccination will be reported.|Baseline (pre vaccination) and week 10|25/27 pts analyzed because 2x10(6) viable cells are required to setup the stimulation assay for each antigen at each time point and one patient had no viable cells after thawing blood. One patient could not be analyzed due to an experimental error which was a clog in the flow cytometry that occurred during acquisition for the final assay readout.|||Participants|||Count of Participants
2601226|NCT02153918|Primary|Changes From Baseline to After Surgery of Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Infiltrates|Immunologic CD4 and CD8 cell infiltrate response of a neoadjuvant prime/boost vaccine strategy in prostatectomy specimens. Prostate biopsy specimens are collected and stained for CD4 and CD8 cells. Quantification is reported as the number of stained cells per micron squared of surface area. Change will be noted by utilizing computer automated staining analysis. Density of cell infiltrate will be calculated and the pre and post vaccine values will be compared to determine response to vaccine.|Baseline (pre vaccination) and approximately week 10|Only 26 participants had available tissue for analysis.|||Cell/mm(2)||Inter-Quartile Range|Median
2601227|NCT02153905|Secondary|Number of Participants With Dose-Limiting Toxicity (DLT)|DLT is defined as follows: Grade 3-5 allergic reactions related to the study cell infusion. Grade 3 and greater autoimmune reactions. Grades 3 and greater organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic) not pre-existing or due to the underlying malignancy and occurring within 30 days of study cell infusion and does not resolve within 72 hours. Treatment-related death within 8 weeks of the study cell infusion.|Within 30 days of study cell infusion||||Participants|||Count of Participants
2601228|NCT02153905|Secondary|In Vivo Survival of T-Cell Receptor (TCR) Cells|In vivo survival of gene-engineered lymphocytes derived from the infused cells will be analyzed by tetramer analysis and staining for the T-cell receptor (TCR). Tetramer analysis is measured by % of peripheral blood.|Up to 3 years after study cell infusion|Data is not reported due to dose limiting toxicities leading to premature stop of dose escalation, and also lack of durable objective tumor regression demonstrated by all three patients. Because no further resources will be expended on this closed study, analysis of this secondary outcome measure (via tetramer analysis) will not be performed.||||||
2601229|NCT02153905|Primary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 53 days for the Anti-MAGE-A3 A1 TCR PBL 1x10^9 Cells + Interleukin-2 (IL-2) Arm/Group, and 1 year and 4 months for the Anti-MAGE-A3 A1 TCR PBL 1x10^8 Cells + Interleukin-2 (IL-2) Arm/Group.||||Participants|||Count of Participants
2601230|NCT02153905|Primary|Number of Treatment Related Adverse Events Related to T-Cell Receptor (TCR) Gene-Engineered Cells|Aggregate of all Grade ≥3 adverse events and their frequency possibly, probably or definitely related to the research. Adverse Events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. Grade 3 is severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living (ADL). Grade 4 is life-threatening consequences; urgent intervention indicated. Grade 5 is death related to adverse event.|Date treatment consent signed to end of treatment, approximately 30 days||||adverse events|||Number
2601231|NCT02153905|Primary|Number of Patients With Objective Tumor Regression|Objective tumor regression is defined as the number of participants with a complete or partial response per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|6 and 12 weeks after cell infusion on up to 2 years||||Participants|||Count of Participants
2601232|NCT02153905|Primary|Maximum Tolerated Cell Dose (MTD)|Highest dose at which less than or equal to 1 of 6 patients experienced a dose limiting toxicity (DLT) or the highest dose level studied if DLTs are not observed at any of the dose levels. DLT is defined as follows: Grade 3-5 allergic reactions related to the study cell infusion. Grade 3 and greater autoimmune reactions. Grades 3 and greater organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic) not pre-existing or due to the underlying malignancy and occurring within 30 days of study cell infusion and does not resolve within 72 hours. Treatment-related death within 8 weeks of the study cell infusion.|Within 30 days of study cell infusion, before progression to next-higher dose level|The first participant in the first Arm/Group experienced a dose limiting toxicity so the second cohort was a de-escalation and was not completed. As a result, maximum tolerated dose was not determined.||||||
2601233|NCT02153827|Secondary|Upper Quarter Y Balance Test|Measure of single arm reach with 0 being the least and higher numbers indicating greater distance reached.|6 months||||cm of reach divided by limb length||Standard Deviation|Mean
2601234|NCT02153827|Secondary|Shoulder Active Range of Motion|Degrees of shoulder elevation with 0 being the least and 180 being the greatest.|6 months||||Degrees||Standard Deviation|Mean
2601235|NCT02153827|Secondary|Numeric Pain Rating Scale|0-10 pain scale with 0 meaning no pain and 10 being maximal pain. This is derived from a single item questionnaire.|6 months||||units on a scale 0-10||Standard Deviation|Mean
2601236|NCT02153827|Secondary|Global Rating of Change|Global rating of change is a single item questionnaire asking about total change since beginning treatment. The scale ranges from -7 (a great deal worse) to +7 (a great deal better). The unit of measure is scores on a scale.|6 months||||units on a scale||Standard Deviation|Mean
2601237|NCT02153827|Primary|Change in Western Ontario Rotator Cuff Index|shoulder functional self report measure is a disease specific self reported outcome measure for individuals experiencing rotator cuff pathology. A score of 0 is the minimum score and indicates low levels of shoulder function. A score of 100 is the maximum score and indicates full shoulder function. Scores are derived by summing all 5 subscales and dividing that number by the total available number of 2100. Units for each item are derived from a visual analog scale totaling 100cm.|6 months||||units on a scale derived from 100cm vas||Standard Deviation|Mean
2601238|NCT02153788|Secondary|Mean Change in the Hospital Anxiety and Depression Scale - Depression (HADS-D)|A scale designed to detect states of anxiety and depression in the setting of an outpatient clinic, that consists of 2 sets: the HADS-A (Anxiety) and HADS-D (Depression). This is a series of 7 questions in each set (for a total of 14), assessed on a scale from 0-4, 0 being the response that indicates the least anxiety or depression, and 4 the most. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|Baseline, week 12||||units on a scale||Standard Deviation|Mean
2601239|NCT02153788|Secondary|Mean Change in the Distress Thermometer|A clinical tool that has been validated widely especially in cancer patients, to detect clinically significant emotional distress. This is a one-item scale that asks participants to rate their distress on scale from 0-100. Lower scores represent less distress and higher scores indicate greater distress.|Baseline, week 12||||units on a scale||Standard Deviation|Mean
2601240|NCT02153788|Secondary|Mean Change in the Hospital Anxiety and Depression Scale - Anxiety (HADS-A)|A scale designed to detect states of anxiety and depression in the setting of an outpatient clinic, that consists of 2 sets: the HADS-A (Anxiety) and HADS-D (Depression). This is a series of 7 questions in each set (for a total of 14), assessed on a scale from 0-4, 0 being the response that indicates the least anxiety or depression, and 4 the most. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|Baseline, week 12||||units on a scale||Standard Deviation|Mean
2601241|NCT02153788|Secondary|Mean Change in Piper Fatigue Score|A multidimensional scale for measuring fatigue, whose validity and reliability have been established across many patient populations including cancer patients, HIV, pregnancy, and myocardial infarction. There are 22 questions, in 3 subscales that measure behavioral, affective meaning, sensory and cognitive/mood aspects of fatigue, each scored on an 11-point likhert scale with a score of 0-10, 0 indicating no fatigue and 10 indicating the most severe fatigue. The Piper Fatigue Scale can range from 0 to 220 with higher scores indicating greater fatigue.|Baseline, week 12||||units on a scale||Standard Deviation|Mean
2601242|NCT02153788|Secondary|Mean Change in Self-reported Total Sleep Time|Mean change in self-reported total sleep time from randomization to the end of the open label phase|Randomization to the end of the open label phase, approximately 1 week|Data not collected, and therefore not analyzed.||||||
2601243|NCT02153788|Secondary|Mean Change in Self Reported Total Sleep Time|Mean change in self reported Total Sleep Time from Randomization to Final Study Visit in the placebo-controlled phase.|Randomization to final study visit, approximately 12 weeks|Data not collected, and therefore not analyzed.||||||
2601244|NCT02153788|Primary|Mean Change in the Insomnia Severity Index|Mean change in the total score of the Insomnia Severity Index from Randomization to Final Study Visit after 12 weeks of double blind, placebo controlled dosing. The Insomnia Severity Index (ISI), is a 7-item questionnaire on a Likhert scale (0-4) assessing sleep initiation, sleep maintenance, satisfaction/distress over sleep problems, and daytime dysfunction. Responses to each item are summed to obtain a total score to determine the severity of insomnia. The total score can range from 0 to 28 with higher scores indicating greater insomnia severity.|Randomization to final study visit, approximately 12 weeks||||units on a scale||Standard Deviation|Mean
2601245|NCT02153736|Secondary|Test of Infant Motor Performance (TIMP)|The TIMP is a standardized and norm references test of motor control and posture in infants 4 months of age and younger which is commonly used with infants starting at 34 weeks of post-menstrual age. Change in raw score from baseline to end of the intervention is reported. The TIMP raw score ranges from 0 to 142. A higher score represented greater performance in motor control and posture.|Baseline to End of intervention|Full Sample after infants lost to follow up who are not included in this analysis.|||Raw Score on the TIMP||Inter-Quartile Range|Median
2601246|NCT02153736|Secondary|Bayley Scales of Infant and Toddler Development (Bayley).|The Bayley-III is a norm references standardized developmental assessment of Motor, Cognitive, and Language skills. Composite scores for each domain have a mean of 100 and a standard deviation of 15. A score of 85-115 is considered average. Higher composite scores represent higher or better performance on that subtest. The Bayley was administered at the final follow-up visit and 3 months after the intervention ended.|3 month post intervention|At 3 months post intervention the sample was consistent with that described in the study sample post lose to followup.|||Mean Composite Score on Bayley||Standard Deviation|Mean
2601247|NCT02153736|Secondary|Parent Child Early Relational Assessment (PCERA)|The Parent-Child Early Relational Assessment (PCERA; Clark, 2010; Clark, 1999) was designed to assess mother-infant interaction. In this study PCERA was scored from a video of the feeding interaction. The PCERA is a 65-item observational rating scale (29 parental, 27 infant, and 8 dyadic), designed to assess the amount, duration, and intensity of interaction. Each item was rated on a 3-point ordinal scale with 1-2 indicating an area of concern, 3 indicating an area for some concern and 4- 5 indicating an area of strength. Eight subscales constructed from items of the PCERA have been theoretically derived and confirmed by factor analysis (Clark, 1999; Clark et al., 1997). For ease of analysis this scale was transformed to a -1 to +1 range. Scores were recorded as 1 or 2 = -1, 3= 0, 4 or 5 = 1. The total PCERA score is the mean of all the subscale mean scores and ranged -1 (highest risk of atypical interactions) to +1 (most positive interactions).|Baseline, End phase 1, End of intervention, 1 month post intervention|The sample varied some between visits do to a lack of video taping the parent child interaction on a few occasions because the parent who consented to the study was not present at the time of the visit and the visit could not be rescheduled. The 3 month post intervention visit was dropped.|||Mean Score on PCERA||Standard Deviation|Mean
2601248|NCT02153736|Secondary|Early Feeding Skill Assessment (FES)|The Early Feeding Skills (EFS) was used to assess the infant's oral feeding skills during the video recorded feeding described above. The EFS is a 26-item observational tool that can be used from the start of oral feeding through the maturation of feeding skills. Each item can score 1-3 with one representing the least skill or high frequency of problem (an area of clinical concern), and three representing mature skill or absence of problem (area of strength). Subscales included were ability to maintain engagement in feeding, ability to organize oral-motor functioning, ability to coordinate swallowing, and ability to maintain physiological stability. The sum of all the items in a subscale divided by the number of items in the subscale gives the subscale score of 1-3. The sum of all subscales was used to create an EFS total score which could range from 2 to 12 with a higher score reflecting a better feeding performance.|Baseline, End phase 1, End of intervention, 1 and 3 months post intervention|Some infants were not able to orally feed in which case this measure was not included. In addition, some visits were missing feeding assessments for missing data. Thus the sample included varied some between visits.|||EFS Total score||Standard Deviation|Mean
2601249|NCT02153736|Primary|Early Problem Solving Indicator (EPSI)|Problem-solving behaviors were assessed using the Early Problem Solving Indicator (EPSI). The EPSI is the cognitive subtest of the Individual Growth and Development Indicators designed to measure infant and toddler play-based problem-solving through 36 months of age. It defines problem-solving as consisting of visual exploration, object manipulation and memory. The infant was video-recorded interacting with 3 standard toys: pop-up animals toy, 6 seriated, plastic cups, and a gum ball machine with 5 balls. Infants were given each toy for 2 minutes. The frequency of 4 mutually exclusive behaviors (look, explore, function, solution) were coded using definitions from the EPSI protocol. time. The total number of problem solving behaviors was calculated as a sum of look, explore, function, and solution for each infant at each visit and reported as the total EPSI frequency with a higher frequency reflecting more problem solving behaviors.|End of intervention, 1 and 3 months post intervention|Same as primary population with the 2 infants lost to follow up not included.|||# of Problem Solving Behaviors in 6 min||Standard Deviation|Mean
2601250|NCT02153736|Primary|Reaching (Toy Contact Duration)|Duration the infant is in contact with the target is used to quantify changes in reaching.|1 month post intervention||||Seconds||Standard Deviation|Mean
2601251|NCT02153723|Secondary|Visual Attention (Fixation Length) Assessed by Eye-tracking TX300 Tobii Computer.|"The standard method of assessing visual attention in neuropsychology is by measuring:~A)number of fixations (how many times the subject looks at each of the 2 visual targets). The higher number of fixations, the more attentive the subject to that visual target.~B) duration of fixations in seconds (the longer the fixation the more attentive). Duration of fixations correlates with intelligence: the smarter the person is the shorter his fixations are.~Eye-tracking data was recorded at 300 Hz sampling rate using a Tobii T300 (Tobii Technology AB, Danderyd, Sweden). The measured index is called the Novelty Score which indicates the percentage of time spent looking at novel visual target. Visual attention is indexed by number of fixations on novel target on test.~Duration of testing session was 2 minutes."|Baseline and Final week of treatment (week 32)|Only 7 of the 10 recruited participants were able to complete the cognitive assessment. The remaining 3 participants could not be tested due to technical reasons.|||seconds||Inter-Quartile Range|Median
2601252|NCT02153723|Secondary|Visual Attention (Number of Fixations) Assessed by Eye-tracking TX300 Tobii Computer.|"Visual attention is indexed by duration and number of fixations on novel target on testing. The standard method of assessing visual attention in neuropsychology is by measuring:~A)number of fixations (how many times the subject looks at each of the 2 visual targets). The higher number of fixations, the more attentive the subject to that visual target.~B) duration of fixations in seconds (the longer the fixation the more attentive). Duration of fixations correlates with intelligence: the smarter the person is the shorter his fixations are.~Eye-tracking data was recorded at 300 Hz sampling rate using a Tobii T300 (Tobii Technology AB, Danderyd, Sweden). The measured index is called the Novelty Score which indicates the percentage of time spent looking at novel visual target. Duration of testing session was 2 minutes."|Baseline and Final week of treatment (week 32)|Only 7 of the 10 recruited participants were able to complete the cognitive assessment. The remaining 3 participants could not be tested due to technical reasons.|||number of fixations||Inter-Quartile Range|Median
2601253|NCT02153723|Secondary|Visual Memory Novelty Score as Assessed by TX300 Tobii Computer.|"Eye-tracking is considered an indication of visual memory. Eye-tracking data was recorded at 300 Hz sampling rate using a Tobii T300 computer (Tobii Technology, Danderyd, Sweden). The actual data given by the computer represents the percentage of time spent looking at a novel visual target - this is called the novelty score. Visual memory, as indexed by the novelty score, is the percentage of time spent looking at a novel target during the test (visual paired comparison paradigm). Duration of testing was 2 minutes."|Baseline and Final week of treatment (week 32)|Only 7 of the 10 recruited participants were able to complete the cognitive assessment. The remaining 3 participants could not be tested due to technical reasons.|||percentage of time||Inter-Quartile Range|Median
2601254|NCT02153723|Secondary|Breath Hold Time (Assessed in the Sleep Monitoring Lab)|Breath Hold Time is defined as percentage of time spent holding the breath in a specific time unit. It is measured by a standard medical technique where belts are placed on the chest and abdomen to record movement and sensors are used to record nasal flow. Wake respiration was monitored with sleep monitoring equipment during the daytime at the polysomnography laboratory with additional oronasal airflow, EMG, EEG and video monitoring to confirm wakefulness during the period of study.|Baseline and Final week of treatment (week 32)|One of the 10 enrolled patients experienced panic attack during the respiratory function testing so that session was discontinued. This left 9 participants for final analysis.|||percentage of time||Inter-Quartile Range|Median
2601255|NCT02153723|Secondary|Breath Hold Index (Number of Breath Holds Per Hour; Assessed in the Sleep Monitoring Lab)|Breath hold index is defined as number of breath holds/hour. Respirations were monitored with sleep monitoring equipment during the daytime at the polysomnography laboratory with additional oronasal airflow, electromyography (EMG), EEG and video monitoring to confirm wakefulness during the period of study.|Baseline and during final week of treatment (week 32)|One of the 10 enrolled patients experienced panic attack during the respiratory function testing so that session was discontinued. This left 9 participants for final analysis.|||number of breath holds/hour||Inter-Quartile Range|Median
2601256|NCT02153723|Primary|Gait Velocity as Measured by GAITRite System|To perform quantitative gait assessments a computerized walkway (457 × 90.2 × 0.64cm) with embedded pressure sensors (GAIT Rite system) was used. Subjects walked on the walkway for two trials, while wearing comfortable footwear.|Baseline and Final week of treatment (week 32)|All 10 patients were females with genetically confirmed Rett syndrome. All were at least 10 years old and ambulatory (walking without assistance at the time of their enrollment).|||cm/sec||Inter-Quartile Range|Median
2601257|NCT02153710|Secondary|Verbs Correctly Named|Change in confrontation naming of verbs were scored for accuracy and percent correct (0% to 100%) was analyzed before versus 3 months post treatment.|Pretreatment to 3 months following treatment termination change||||percent correct||Standard Deviation|Mean
2601258|NCT02153710|Secondary|Response Latency|Change in response latency of confrontation naming pre-treatment versus 3 months post treatment.|Pretreatment to 3 months following treatment termination change||||seconds||Standard Deviation|Mean
2601259|NCT02153710|Primary|Spoken Word Production (Confrontation Naming)|Reporting a change in percent correct scores pre-treatment versus 3-months post treatment. (0-100% scale)|Pretreatment to 3 months following treatment termination change||||percent correct||Standard Deviation|Mean
2601260|NCT02153671|Other Pre-specified|Number of Subjects Experiencing Any Adverse Event Related to the A(H5N1) Inactivated Influenza Vaccine|Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination|56 days||||Participants|||Count of Participants
2601261|NCT02153671|Other Pre-specified|Number of Subjects Experiencing Adverse Events After Receiving A(H5N1) Inactivated Influenza Vaccine|Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination.|56 days||||Participants|||Count of Participants
2601262|NCT02153671|Secondary|Mean Avidity Index for Serum Immunoglobulin G (IgG) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine|The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.|28 days|Subjects with seroconversion were included in the analysis.|||avidity index||Standard Deviation|Mean
2601263|NCT02153671|Secondary|Mean Avidity Index for Serum Immunoglobulin A (IgA) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine|The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.|28 days|Subjects with seroconversion were included in the analysis.|||avidity index||Standard Deviation|Mean
2601264|NCT02153671|Secondary|Mean Avidity Index for Serum Immunoglobulin G (IgG) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine|The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.|28 days|Subjects with seroconversion were included in the analysis.|||avidity index||Standard Deviation|Mean
2601265|NCT02153671|Secondary|Mean Avidity Index for Serum Immunoglobulin A (IgA) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine|The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.|28 days|Subjects with seroconversion were included in the analysis.|||avidity index||Standard Deviation|Mean
2601266|NCT02153671|Secondary|Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin G (IgG) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine|The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.|28 days|Subjects with seroconversion were included in the analysis.|||Participants|||Count of Participants
2601267|NCT02153671|Secondary|Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin A (IgA) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine|The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.|28 days|Subjects with seroconversion were included in the analysis.|||Participants|||Count of Participants
2601268|NCT02153671|Secondary|Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin G (IgG) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine|The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.|28 days|Subjects with seroconversion were included in the analysis.|||Participants|||Count of Participants
2601269|NCT02153671|Secondary|Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin A (IgA) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine|The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.|28 days|Subjects with seroconversion were included in the analysis.|||Participants|||Count of Participants
2601270|NCT02153671|Primary|Number and Percentage of Subjects With Seroconversion for Immunoglobulin G (IgG) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|A four-fold or greater antibody rise in titer was considered to be a seroconversion. Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.|56 days||||Participants|||Count of Participants
2601271|NCT02153671|Primary|Number and Percentage of Subjects With Seroconversion for Immunoglobulin G (IgG) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|A four-fold or greater antibody rise in titer was considered to be a seroconversion. Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.|56 days||||Participants|||Count of Participants
2601272|NCT02153671|Primary|Number and Percentage of Subjects With Seroconversion for Immunoglobulin A (IgA) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|A four-fold or greater antibody rise in titer was considered to be a seroconversion. Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.|56 days||||Participants|||Count of Participants
2601273|NCT02153671|Primary|Number and Percentage of Subjects With Seroconversion for Immunoglobulin A (IgA) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|A four-fold or greater antibody rise in titer was considered to be a seroconversion. Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.|56 days||||Participants|||Count of Participants
2602962|NCT02137512|Secondary|Time Spent <50 mg/dL - Main Phase, Day and Night|Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2601274|NCT02153671|Primary|Geometric Mean Titer of Serum Immunoglobulin G (IgG) Response to A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.|56 days||||titer||Standard Deviation|Geometric Mean
2601275|NCT02153671|Primary|Geometric Mean Titer of Serum Immunoglobulin G (IgG) Response to A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.|56 days||||titer||Standard Deviation|Geometric Mean
2601276|NCT02153671|Primary|Geometric Mean Titer of Serum Immunoglobulin A (IgA) Response to A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.|56 days||||titer||Standard Deviation|Geometric Mean
2601277|NCT02153671|Primary|Geometric Mean Titer of Serum Immunoglobulin A (IgA) Response to A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.|56 days||||titer||Standard Deviation|Geometric Mean
2601278|NCT02153671|Primary|Number and Percentage of Subjects With Seroprotective Titer of Microneutralization (MN) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|Serum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the virus in the tissue culture (TCID50). Seroprotection was defined as ≥1:40 antibody titer.|56 days||||Participants|||Count of Participants
2601279|NCT02153671|Primary|Number and Percentage of Subjects With Seroprotective Titer of Microneutralization (MN) Antibody Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|Serum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the virus in the tissue culture (TCID50). Seroprotection was defined as ≥1:40 antibody titer.|56 days||||Participants|||Count of Participants
2601280|NCT02153671|Primary|Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|Seroprotection was defined as ≥1:40 antibody titer. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.|56 days||||Participants|||Count of Participants
2601281|NCT02153671|Primary|Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|Seroprotection was defined as ≥1:40 antibody titer. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.|56 days||||Participants|||Count of Participants
2601282|NCT02153671|Primary|Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|Seroprotection was defined as ≥1:40 antibody titer. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.|56 days||||Participants|||Count of Participants
2601283|NCT02153671|Primary|Number and Percentage of Subjects With Seroprotective Titers for Serum Hemagglutination Inhibition (HAI) Antibody Against 17/t/Tur (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|Seroprotection was defined as ≥1:40 antibody titer. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.|56 days||||Participants|||Count of Participants
2601284|NCT02153671|Primary|Number and Percentage of Subjects With Seroconversion for Microneutralization (MN) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|Serum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the virus in the tissue culture (TCID50). A four-fold or greater antibody rise in titer was considered to be a seroconversion.|56 days||||Participants|||Count of Participants
2601285|NCT02153671|Primary|Number and Percentage of Subjects With Seroconversion for Microneutralization (MN) Antibody Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|Serum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the virus in the tissue culture (TCID50). A four-fold or greater antibody rise in titer was considered to be a seroconversion.|56 days||||Participants|||Count of Participants
2601286|NCT02153671|Primary|Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|A four-fold or greater antibody rise in titer was considered to be a seroconversion. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.|56 days||||Participants|||Count of Participants
2601287|NCT02153671|Primary|Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|A four-fold or greater antibody rise in titer was considered to be a seroconversion. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.|56 days||||Participants|||Count of Participants
2601288|NCT02153671|Primary|Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|A four-fold or greater antibody rise in titer was considered to be a seroconversion. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.|56 days||||Participants|||Count of Participants
2601289|NCT02153671|Primary|Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against 17/t/Tur (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|A four-fold or greater antibody rise in titer was considered to be a seroconversion. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.|56 days||||Participants|||Count of Participants
2601290|NCT02153671|Primary|Geometric Mean Titer of Microneutralization Antibody Response to A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|Serum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the virus in the tissue culture (TCID50).|56 days||||titer||95% Confidence Interval|Geometric Mean
2601332|NCT02153398|Secondary|AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.|||μmol*h/L||Standard Deviation|Mean
2601291|NCT02153671|Primary|Geometric Mean Titer of Microneutralization Antibody Response to A/17/Turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|Serum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the virus in the tissue culture (TCID50).|56 days||||titer||95% Confidence Interval|Geometric Mean
2601292|NCT02153671|Primary|Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/Turkey/Turkey/5/05(H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells. A four-fold or greater antibody rise in titer was considered to be a seroconversion.|56 days||||titer||95% Confidence Interval|Geometric Mean
2601293|NCT02153671|Primary|Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells. A four-fold or greater antibody rise in titer was considered to be a seroconversion.|56 days||||titer||95% Confidence Interval|Geometric Mean
2601294|NCT02153671|Primary|Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells. A four-fold or greater antibody rise in titer was considered to be a seroconversion.|56 days||||titer||95% Confidence Interval|Geometric Mean
2601295|NCT02153671|Primary|Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)|The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional World Health Organization (WHO)-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells. A four-fold or greater antibody rise in titer was considered to be a seroconversion.|56 days||||titer||95% Confidence Interval|Geometric Mean
2601296|NCT02153645|Secondary|Mobility State Self-Assessment - Subject Diary Cards|"Change from baseline in the number of awake hours without troublesome dyskinesia (involuntary movements). Every half hour the subject will indicate in the diary if the medication has (ON) or has not (OFF) produced benefits in terms of mobility, slowness and rigidity. Valid diaries of the 3 consecutive days prior to each visit will be averaged with respect to the number of awake hours without troublesome dyskinesia. The change from baseline in the number of waking hours that subjects report being ON without troublesome dyskinesias will be analyzed at analysis visits Day 14 and Day 98 of treatment. Higher scores mean a better outcome and the maximum value is 24 hours."|Day 14 and Day 98 of treatment|The number analyzed was the number of subjects with values at each time point.|||score on a scale||Standard Deviation|Mean
2601297|NCT02153645|Primary|Unified Dyskinesia Rating Scale|The Unified Dyskinesia Rating Scale is a validated tool for assessment of dyskinesia (involuntary movements) in Parkinson's Disease patients. Rating consists of the change from baseline to Day 98 of the sum of the 26 questions comprising the questionnaire. Each question in the questionnaire is rated on a 5 point scale from 0-4 where 0 is a better outcome. Questions assess: over the past week total hours with dyskinesia and total hours without dyskinesia; problems with speech, chewing and swallowing, eating, dressing, hygiene, handwriting, hobbies, balance, socializing, emotions, spasm or cramps, pain without dystonia (spasm or cramps) and pain from dystonia, the degree of impairment for each of 7 body parts, and the degree of disability in communication, drinking from a cup, dressing and ambulation. The minimum score is 0 (better) and the maximum score is 130 (worse).|From baseline to Day 98||||score on a scale||Standard Deviation|Mean
2601298|NCT02153632|Secondary|Mobility State Self-Assessment - Subject Diary Cards|"hange from baseline in the number of awake hours without troublesome dyskinesia (involuntary movements). Every half hour the subject will indicate in the diary if the medication has (ON) or has not (OFF) produced benefits in terms of mobility, slowness and rigidity. Valid diaries of the 3 consecutive days prior to each visit will be averaged with respect to the number of awake hours without troublesome dyskinesia. The change from baseline in the number of waking hours that subjects report being ON without troublesome dyskinesias will be analyzed at analysis visits Day 14 and Day 98 of treatment. Higher scores mean a better outcome and the maximum value is 24 hours."|Day 14 and Day 98 of treatment|The number analyzed is the number of subjects with values at each time point.|||Hours||Standard Deviation|Mean
2601646|NCT02150954|Primary|Time to the Second Stage of Labor|The second stage of labor was defined as the time from complete cervical dilation to delivery of the fetus.|foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days)||||hours||Inter-Quartile Range|Mean
2601299|NCT02153632|Primary|Unified Dyskinesia Rating Scale|The Unified Dyskinesia Rating Scale is a validated tool for assessment of dyskinesia (involuntary movements) in Parkinson's Disease patients. Rating consists of the change from baseline to Day 98 of the sum of the 26 questions comprising the questionnaire. Each question in the questionnaire is rated on a 5 point scale from 0-4 where 0 is a better outcome. Questions assess: over the past week total hours with dyskinesia and total hours without dyskinesia; problems with speech, chewing and swallowing, eating, dressing, hygiene, handwriting, hobbies, balance, socializing, emotions, spasm or cramps, pain without dystonia and pain from dystonia. The minimum (better) value is 0 and the maximum (worse) value is 130.|Change from baseline to Day 98|Intent to treat population|||score on a scale||Standard Deviation|Mean
2601300|NCT02153528|Secondary|Fever Resolution|Comparison of fever resolution after 2 weeks of treatment between both treatment arms.|after 2 weeks of treatment|Total of participants with fever at baseline.|||Participants|||Count of Participants
2601301|NCT02153528|Secondary|Weight Gain|Weight gain from baseline until end-of-treatment comparison between both treatment arms.|until end of treatment (month eight)||||kg||Standard Deviation|Mean
2601302|NCT02153528|Secondary|Area Under the Curve of Auramine Resp. FDA at 2 Weeks to Predict Adverse Treatment Outcome at 1 Year After Treatment Completion|Area under the ROC curve (AUC) to predict adverse treatment outcome. The X-axis represents the 1-specificity, the Y-axis represents sensitivity. The AUC is estimated with 95% confidence interval.|Auramine/FDA at 2 weeks and adverse treatment outcome 1 year after treatment completion||||no unit is used for AUROC||95% Confidence Interval|Number
2601303|NCT02153528|Secondary|Proportion of Acquired Rifampicin Resistance Among Failures and Relapses|number of failure / relapse cases without mutation detected at diagnosis as the denominator and comparing intervention and control arms.|12 months after end of TB treatment|ITT analysis. This analysis only includes failure / relapse cases without mutation detected at diagnosis|||Participants|||Count of Participants
2601304|NCT02153528|Secondary|the Negative Predictive Value of Conversion at 2 Weeks for Relapse.|The Negative Predictive value (and 95% CI) of conversion in the intervention arm will be estimated as the % of relapses among those with a minimum 1 log decline in the number of AFB, or who are already negative or only scanty positive on AFB smear (auramine or FDA).|at 2 weeks of treatment|ITT analysis. This analysis only includes participants in the intervention arm who are negative on auramine smear resp. FDA smear at 2 weeks.|||Participants|||Count of Participants
2601305|NCT02153528|Secondary|Number of Initial Resistant TB Cases Who Switched to MDR-TB Treatment or Were Cured|To assess the effectiveness of FDA vital staining versus fever screening for early switch of non-responding rifampicin resistant TB to MDR-TB treatment|at two weeks of treatment|7 initial resistant cases (5 in control group and 2 in intervention group).|||Participants|||Count of Participants
2601306|NCT02153528|Secondary|High-level Rifampicin Resistant TB Adverse Treatment Outcomes|To assess whether the study regimen also cures high-level rifampicin resistant TB. Adverse treatment outcomes will be described and compared among treatment groups in subgroups defined by initial rifampicin resistance mutations (performed in all patients) detected.|12 months after end of TB treatment|ITT analysis population. Compared to analysis population of primary objective - TB treatment outcome, 24 subjects were excluded from this analysis due to missing or negative sequencing results (8 in control group, 16 in intervention group).|||Participants|||Count of Participants
2601307|NCT02153528|Primary|Number of Participants Who Develop Liver Toxicity|Grade 3-4 Liver Toxicity following NIH common toxicity criteria (CTC), including transaminase increases to >5-20 ULN (grade 3), or > 20 ULN (grade 4)|until month eight|One participant was allocated to double rifampicin arm but received standard TB treatment, and was analysed in the standard TB treatment arm.Two participants were deleted from analysis because they had grade 3 liver toxicity at baseline and 6 participants were deleted because they did not have any follow-up ALT values.|||Participants|||Count of Participants
2601308|NCT02153528|Primary|Tuberculose Treatment Outcome|"Following current WHO guidelines, an adverse treatment outcome is defined as any occurrence of the following:~Relapse: Cured previously from TB or completed treatment for TB and now having bacteriologically positive sputum for TB (at 12 months follow-up or at an earlier time point)~Default: The patient whose treatment was interrupted for ≥ 2 consecutive months.~Failure: Sputum positive for TB at 5 months or later during treatment. In line with current WHO recommendations, patients detected with MDR-TB or rifampicin resistance before this or another outcome applies and switched to the MDR-TB regimen will be excluded from the outcome analysis.18 Failure will also be declared if the regimen has to be changed for at least 2 drugs due to adverse events.~Death: All-cause mortality between case registration and end of TB treatment (related or not to TB or TB treatment)"|12 months after end of treatment|Intention-to-treat analysis. Additional 4 subjects were removed from the ITT analysis because they switched to MDR regimen (3 in control arm, 1 in intervention arm). 4 subjects (intervention arm) were removed from the ITT analysis because they were enrolled twice.|||Participants|||Count of Participants
2601309|NCT02153489|Other Pre-specified|Change From Baseline in Number of Steps Per Day||Week 3 of treatment||||Number of steps per day||Standard Error|Least Squares Mean
2601310|NCT02153489|Other Pre-specified|Change From Baseline in Duration of at Least Moderate Activity|Moderate activity was defined as any physical activity >3 metabolic equivalents|Week 3 of treatment||||Minutes||Standard Error|Least Squares Mean
2601311|NCT02153489|Other Pre-specified|Change From Baseline in Total Sleep Time||Week 3 of treatment||||Minutes||Standard Error|Least Squares Mean
2601312|NCT02153489|Other Pre-specified|Change From Baseline in Sleep Efficiency|Sleep efficiency is calculated as the total sleep time as a proportion of total time in bed|Week 3 of treatment||||Percentage of total time in bed||Standard Error|Least Squares Mean
2601313|NCT02153489|Other Pre-specified|Change From Baseline in Proportion of Sleep Stage REM as a Percentage of Total Sleep Time||Week 3 of treatment||||Percentage of total sleep time||Standard Error|Least Squares Mean
2601314|NCT02153489|Other Pre-specified|Change From Baseline in Oxygen Desaturation Index (ODI) Per Hour of Total Sleep Time|The oxygen desaturation index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline. In this study, any event with a 4% decrease in blood oxygen levels counted towards the total|Week 3 of treatment||||Events/hr||Standard Error|Least Squares Mean
2620697|NCT01953328|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2601316|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of COPD Symptoms Limiting Evening Activities|The evening symptoms questionnaire was filled out after the second medication administration of the day and before bedtime. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). Symptoms assessed over 24 weeks included change from baseline in the severity of evening cough, wheezing, shortness of breath and tightness of the chest, chest congestion, difficulty bringing up phlegm, overall evening symptom severity, and limitation of evening activities due to COPD symptoms|Week 3 of treatment||||Score on a scale||Standard Deviation|Mean
2601317|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of COPD Symptoms Limiting Early Morning Activities|Night-time and early-morning symptoms were recorded every morning using the Early-Morning Symptoms of COPD Instrument [EMSCI] and the Night-time Symptoms of COPD Instrument [NiSCI]. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). The questionnaires also evaluated nocturnal awakenings and limitation of early-morning activities (scores ranged from 0 [no limitation] to 4 [a very great deal]). Symptoms assessed over 24 weeks included change from baseline in the severity of night-time and early-morning cough, wheezing, shortness of breath and difficulty bringing up phlegm, overall night-time and early-morning symptom severity, number of nocturnal awakenings and limitation of early-morning activities due to COPD symptoms|Week 3 of treatment||||Score on a scale||Standard Deviation|Mean
2601318|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of Overall Night-time COPD Symptom Severity|Night-time and early-morning symptoms were recorded every morning using the Early-Morning Symptoms of COPD Instrument [EMSCI] and the Night-time Symptoms of COPD Instrument [NiSCI]. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). The questionnaires also evaluated nocturnal awakenings and limitation of early-morning activities (scores ranged from 0 [no limitation] to 4 [a very great deal]). Symptoms assessed over 24 weeks included change from baseline in the severity of night-time and early-morning cough, wheezing, shortness of breath and difficulty bringing up phlegm, overall night-time and early-morning symptom severity, number of nocturnal awakenings and limitation of early-morning activities due to COPD symptoms|Week 3 of treatment||||Score on a scale||Standard Deviation|Mean
2601319|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of Overall Evening COPD Symptom Severity|The evening symptoms questionnaire was filled out after the second medication administration of the day and before bedtime. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). Symptoms assessed over 24 weeks included change from baseline in the severity of evening cough, wheezing, shortness of breath and tightness of the chest, chest congestion, difficulty bringing up phlegm, overall evening symptom severity, and limitation of evening activities due to COPD symptoms|Week 3 of treatment||||Score on a scale||Standard Deviation|Mean
2601320|NCT02153489|Other Pre-specified|Change From Baseline in the Average Rating of Overall Early Morning COPD Symptom Severity|Night-time and early-morning symptoms were recorded every morning using the Early-Morning Symptoms of COPD Instrument [EMSCI] and the Night-time Symptoms of COPD Instrument [NiSCI]. Scores ranged from 0 (no symptoms) to 4 (very severe symptoms). The questionnaires also evaluated nocturnal awakenings and limitation of early-morning activities (scores ranged from 0 [no limitation] to 4 [a very great deal]). Symptoms assessed over 24 weeks included change from baseline in the severity of night-time and early-morning cough, wheezing, shortness of breath and difficulty bringing up phlegm, overall night-time and early-morning symptom severity, number of nocturnal awakenings and limitation of early-morning activities due to COPD symptoms|Week 3 of treatment||||Score on a scale||Standard Deviation|Mean
2601321|NCT02153489|Other Pre-specified|Change From Baseline in Normalized FEV1 AUC12-24hr||12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment||||L/sec*hr||Standard Error|Least Squares Mean
2601322|NCT02153489|Other Pre-specified|Change From Baseline in Normalized FEV1 AUC0-12hr||0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11 and 12 hours at Week 3 of treatment||||L/sec*hr||Standard Error|Least Squares Mean
2601323|NCT02153489|Other Pre-specified|Change From Baseline in Peak FEV1||Week 3 of treatment||||Liters/sec||Standard Error|Least Squares Mean
2601324|NCT02153489|Other Pre-specified|Change From Baseline in Morning Trough FEV1||Week 3 of treatment||||Liters/sec||Standard Error|Least Squares Mean
2601325|NCT02153489|Primary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-24hr||0, 0.5, 1, 2, 3, 4, 6, 8, 10, 11, 12, 12.5, 13, 14, 15, 16, 19, 22, 23, and 24 hours at Week 3 of treatment||||L/sec*hr||Standard Error|Least Squares Mean
2601326|NCT02153476|Primary|Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT)|The primary endpoint of this study is observation of pharmacologic resolution of VMA, with VMA defined as vitreous adhesion to the macula within a 6mm central retinal field surrounded by elevation of the posterior vitreous cortex as seen on OCT.|90 Days||||Participants|||Count of Participants
2601327|NCT02153398|Secondary|Apparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.|||L||Standard Deviation|Mean
2601328|NCT02153398|Secondary|Apparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.|||L/h||Standard Deviation|Mean
2601329|NCT02153398|Secondary|Elimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.|||hour||Standard Deviation|Mean
2601330|NCT02153398|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.|||hour||Full Range|Median
2601331|NCT02153398|Secondary|Maximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.|||μmol/L||Standard Deviation|Mean
2601333|NCT02153398|Secondary|Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose||0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose|All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the pharmacokinetics (PK).|||μmol*h/L||Standard Deviation|Mean
2601334|NCT02153398|Primary|Aggravation of Regurgitation at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of regurgitation were defined as those who had no regurgitation at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had no regurgitation at pre-dose and were evaluated the symptom at Week 8 by investigators.|||Participants|||Number
2601335|NCT02153398|Primary|Aggravation of Upper Abdominal Discomfort at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of upper abdominal discomfort were defined as those who had no upper abdominal discomfort at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had no upper abdominal discomfort at pre-dose and were evaluated the symptom at Week 8 by investigators.|||Participants|||Number
2601336|NCT02153398|Primary|Aggravation of Epigastric Pain at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of epigastric pain were defined as those who had no epigastric pain at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had no epigastric pain at pre-dose and were evaluated the symptom at Week 8 by investigators.|||Participants|||Number
2601337|NCT02153398|Primary|Aggravation of Heartburn at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of heartburn were defined as those who had no heartburn at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had no heartburn at pre-dose and were evaluated the symptom at Week 8 by investigators.|||Participants|||Number
2601338|NCT02153398|Primary|Disappearance of Regurgitation at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of regurgitation were defined as those who had a regurgitation at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had a regurgitation at pre-dose and were evaluated the symptom at Week 8 by investigators.|||Participants|||Number
2601339|NCT02153398|Primary|Disappearance of Upper Abdominal Discomfort at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of upper abdominal discomfort were defined as those who had an upper abdominal discomfort at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had an upper abdominal discomfort at pre-dose and were evaluated the symptom at Week 8 by investigators.|||Participants|||Number
2601340|NCT02153398|Primary|Disappearance of Epigastric Pain at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of epigastric pain were defined as those who had an epigastric pain at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had an epigastric pain at pre-dose and were evaluated the symptom at Week 8 by investigators.|||Participants|||Number
2601341|NCT02153398|Primary|Disappearance of Heartburn at Week 8 by Investigators|The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of heartburn were defined as those who had a heartburn at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.|8 weeks|Participants who had a heartburn at pre-dose and were evaluated the symptom at Week 8 by investigators.|||Participants|||Number
2601342|NCT02153398|Primary|Aggravation of Regurgitation at Week 8 by Patient Diaries|"The aggravation of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of regurgitation were defined as those who selected None to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of Mild, Moderate or Severe at Week 8."|8 weeks|Participants who had no regurgitation at pre-dose in patient diary and obtained available diary data at Week 8.|||participants|||Number
2601343|NCT02153398|Primary|Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries|"The aggravation of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of upper abdominal discomfort were defined as those who selected None to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of Mild, Moderate or Severe at Week 8."|8 weeks|Participants who had no upper abdominal discomfort at pre-dose in patient diary and obtained available diary data at Week 8.|||participants|||Number
2601344|NCT02153398|Primary|Aggravation of Epigastric Pain at Week 8 by Patient Diaries|"The aggravation of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of epigastric pain were defined as those who selected None to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of Mild, Moderate or Severe at Week 8."|8 weeks|Participants who had no epigastric pain at pre-dose in patient diary and obtained available diary data at Week 8.|||participants|||Number
2601363|NCT02153359|Primary|PM2.5-10 Concentration (ug/m^3)|Coarse particulate matter (PM2.5-10) concentration as assessed by a passive filter placed in the participant's home.|Approximately 1 month|2 participants were lost to follow-up in the air cleaner group. 8 participants in the sham air cleaner group had invalid PM10 data and thus could not have PM2.5-10 data calculated.|||ug/m^3||Standard Deviation|Mean
2601345|NCT02153398|Primary|Aggravation of Heartburn at Week 8 by Patient Diaries|"The aggravation of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of heartburn were defined as those who selected None to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of Mild, Moderate or Severe at Week 8."|8 weeks|Participants who had no heartburn at pre-dose in patient diary and obtained available diary data at Week 8.|||participants|||Number
2601346|NCT02153398|Primary|Disappearance of Regurgitation at Week 8 by Patient Diaries|"The disappearance of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of regurgitation were defined as those who selected Mild, Moderate, or Severe to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of None at Week 8."|8 weeks|Participants who had regurgitation at pre-dose in patient diary and obtained available diary data at Week 8.|||Participants|||Number
2601347|NCT02153398|Primary|Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries|"The disappearance of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of upper abdominal discomfort were defined as those who selected Mild, Moderate, or Severe to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of None at Week 8."|8 weeks|Participants who had upper abdominal discomfort at pre-dose in patient diary and obtained available diary data at Week 8.|||Participants|||Number
2601348|NCT02153398|Primary|Disappearance of Epigastric Pain at Week 8 by Patient Diaries|"The disappearance of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of epigastric pain were defined as those who selected Mild, Moderate, or Severe to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of None at Week 8."|8 weeks|Participants who had epigastric pain at pre-dose in patient diary and obtained available diary data at Week 8.|||Participants|||Number
2601349|NCT02153398|Primary|Disappearance of Heartburn at Week 8 by Patient Diaries|"The disappearance of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of heartburn were defined as those who selected Mild, Moderate, or Severe to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of None at Week 8."|8 weeks|Participants who had heartburn at pre-dose in patient diary and obtained available diary data at Week 8.|||Participants|||Number
2601350|NCT02153359|Secondary|FEV1 Percentage of FVC|The pre-bronchodilator forced expiratory volume in 1 second over the forced vital capacity as assessed by spirometry.|1 day|14 participants had missing spirometry data.|||percentage of forced vital capacity||Standard Deviation|Mean
2601351|NCT02153359|Secondary|Pre-bronchodilator Forced Expiratory Volume in 1 Second (Litres)|The pre-bronchodilator forced expiratory volume in 1 second (FEV1) as assessed by spirometry.|1 day|14 participants had missing spirometry data.|||litres||Standard Deviation|Mean
2601352|NCT02153359|Secondary|Pre-bronchodilator Forced Vital Capacity (Litres)|Pre-bronchodilator forced vital capacity (FVC) as assessed with spirometry|1 day|14 participants had missing spirometry data.|||litres||Standard Deviation|Mean
2601353|NCT02153359|Secondary|Bronchoalveolar Lavage Differential Eosinophil Count|The eosinophil percentage in the bronchoalveolar lavage cell count differential.|1 day|2 participants were lost to follow up and 6 participants declined bronchoscopies.|||percentage of total cell count||Standard Deviation|Mean
2601354|NCT02153359|Secondary|Bronchoalveolar Lavage Differential Neutrophil Count|The percentage of neutrophils in the bronchoalveolar lavage cell count.|1 Day|2 participants were lost to follow up and 6 participants declined bronchoscopies.|||percentage of total cell count||Standard Deviation|Mean
2601355|NCT02153359|Secondary|Air Nicotine Concentration (ug/m^3)|Indoor air nicotine concentration as assessed by a passive filter placed in the participant's home.|Approximately 1 month|2 participants were lost to follow-up in the air cleaner group and 1 in the sham air cleaner group had corrupt data that could not be accessed.|||ug/m^3||Standard Deviation|Mean
2601356|NCT02153359|Secondary|Asthma-specific Health-related Quality of Life as Assessed by the Asthma Quality of Life Questionnaire (AQLQ)|The AQLQ is validated clinical tool to assess asthma-specific health-related quality of life instrument that taps both physical and emotional impact of disease. Scores range from 1-7, with higher scores indicating better quality of life.|Approximately 1 month|A total of 9 AQLQ questionnaires were not accessible. There is no data for 4 participants in the air cleaner group and 5 participants in the sham air cleaner group.|||units on a scale||Standard Deviation|Mean
2601357|NCT02153359|Secondary|Asthma Disease Status as Assessed by the Asthma Control and Communication Instrument (ACCI)|The ACCI is a validated clinical tool that measures asthma disease status during routine health care and is valid for use in both black and white populations. The sum of each of the 5 ACCI asthma control domains results in a final ACCI score ranging from 0 (better control) to 19 (worse control).|Approximately 1 month|A total of 9 ACCI questionnaires were not accessible. There is no data for 4 participants in the air cleaner group and 5 participants in the sham air cleaner group.|||units on a scale||Standard Deviation|Mean
2601358|NCT02153359|Secondary|Number of Days of Unscheduled Visits to the Doctor Due to Asthma Symptoms|The number of days of unscheduled, urgent visits to the office, urgent care or emergency department due to asthma symptoms.|7 days|3 participants did not report the number of days of unscheduled doctor visits due to asthma symptoms.|||days||Standard Deviation|Mean
2601359|NCT02153359|Secondary|Number of Days of School/Work Missed Due to Asthma Symptoms|The number of days of school or work missed due to asthma symptoms.|7 days|3 participants did not report the number of days of school/work missed due to asthma symptoms.|||days||Standard Deviation|Mean
2601360|NCT02153359|Secondary|Number of Nights Disrupted by Asthma Symptoms|The number of nights spent sleeping that was disrupted due to asthma symptoms.|7 nights|3 participants did not report the number of nights disrupted due to asthma symptoms.|||nights||Standard Deviation|Mean
2601361|NCT02153359|Secondary|Number of Days With Activity Limitations|Number of reported days with activity limitations due to asthma symptoms.|7 days|3 participants did not report their activity limitations.|||days||Standard Deviation|Mean
2601362|NCT02153359|Secondary|Number of Symptom-free Days|The number of reported days without daytime asthma symptoms (symptom-free days) as based on daily symptom diaries recorded by the patient.|7 days|3 participants did not report their symptoms.|||days||Standard Deviation|Mean
2601364|NCT02153359|Primary|PM2.5 Concentration (ug/m^3)|Fine particulate matter (PM2.5) concentration as assessed by a passive filter placed in the participant's home.|Approximately 1 month|Particulate matter data was missing for 3 participants -- 2 participants were lost to follow-up in the air cleaner group and 1 in the sham air cleaner group had corrupt particulate matter data due to dysfunctional air quality monitoring device.|||ug/m^3||Standard Deviation|Mean
2601365|NCT02153346|Secondary|Work Productivity Loss as Assessed in Hours Using Work Productivity and Activity Impairment (WPAI) During the Specified Time Points|WPAI is a self-administered instrument to determine the degree to which asthma affected work productivity while at work and affected activities outside of work in the last 7 days and yields 4 types of scores: Absenteeism (work time missed/missed due to other reasons); Presenteeism (actual time worked); Work Productivity Loss (affected productivity while working); and Activity Impairment (affected regular activities). The following parameters were presented: Hours (Hrs) missed due to asthma (HMA), Hrs missed due to other reasons (HMO), and Hrs actually worked (HAW); all in the last 7 days.|At BL, 4-Month, 8-Month and 12-Month FUP|Source Population. Only par. with available data in each category (represented by n=X in the category title) were analyzed. Among the 101 par., 35 (35%) were retired and 59 (58%) were working. Only par. working were who completed the WPAI questionnaire were included in the analysis (56 at BL; 49 at 4 months; 37 at 8 months; 44 at FUP).|||Hours||Standard Deviation|Mean
2601366|NCT02153346|Primary|Indirect Cost of Asthma by Level of Asthma Severity Per Participant Per 3 Months at BL and 12-month FUP|Costs of asthma may vary depending on the participant's asthma severity. Asthma severity was based on the standard definitions for severity and ACQ scores: Mild (<0.75), Moderate (>0.75) and Severe (any ACQ score). The following parameters were presented: Cost of absenteeism due to asthma (CAA), cost of presenteeism due to asthma (CPA), cost of absenteeism due to asthma in whom TCC was possible (CAA TCC), cost of presenteeism due to asthma in whom TCC was possible (CPA TCC), and total indirect cost due to asthma (TICA).|BL and 12-month FUP|Source Population. Only participants with available data in each category (represented by n=X in the category title) were analyzed. One third of the participants selected were retired. Only 59 participants were active workers. Therefore the stratification for asthma control and severity included very low numbers (52 at BL; 40 at FUP).|||Canadian Dollars||Standard Deviation|Mean
2601367|NCT02153346|Primary|Indirect Cost of Asthma by Level of Asthma Control Per Participant Per 3 Months at BL and 12-month FUP|Costs of asthma are greater when the asthma is sub-optimally managed and controlled and varies depending on the par. asthma control. Asthma control was assessed using the Asthma Control Questionnaire (ACQ) and par. were asked to recall their experiences during the previous week and respond to the 6 specified questions on a 7-point Likert scale (0=well-controlled; 6=maximum impairment [poorly controlled]; a score of ≤0.75 indicates well controlled symptoms. The following parameters were presented: Cost of absenteeism due to asthma (CAA), cost of presenteeism due to asthma (CPA), cost of absenteeism due to asthma in whom TCC was possible (CAA TCC), cost of presenteeism due to asthma in whom TCC was possible (CPA TCC), and total indirect cost due to asthma (TICA). Only 59 par. were active workers. When stratified by asthma control and severity each stratum had a sample less than 59. Although results are presented. data may not be reliable due to the low number of par. in each stratum.|BL and 12-month FUP|Source Population. Only participants with available data in each category (represented by n=X in the category title) were analyzed. One third of the participants selected were retired. Only 59 participants were active workers. Therefore the stratification for asthma control and severity included very low numbers (52 at BL; 40 at FUP).|||Canadian Dollars||Standard Deviation|Mean
2601368|NCT02153346|Primary|Indirect Cost of Asthma Per Participant Per 3 Months at Baseline (BL) and 12-month Follow-up (FUP)|Participants completed questionnaires within 2 weeks post-recruitment, 4, 8 and 12 months to measure indirect cost of disease, specifically related to productivity. The following questionnaires were used: WPAI helps to determine presenteeism, absenteeism, and total cost calculation (TCC) possible (number of days during the year of study), while VOLP is used to assess the impact of health conditions on lost productivity in monetary units (United states dollars). The following parameters were calculated: Cost of absenteeism due to asthma (CAA), cost of presenteeism due to asthma (CPA), cost of absenteeism due to asthma in whom TCC was possible (CAA TCC), cost of presenteeism due to asthma in whom TCC was possible (CPA TCC), and total indirect cost due to asthma (TICA).|BL and at 12-month FUP|Source Population: all par. with asthma diagnosed by respirologist and followed at outpatient asthma clinic of the HSCM and registered in BD-Asthma/RESP. Only par. with available data in each category (represented by n=X in the category title) were analyzed. One third of par. selected were retired. Only 59 were active workers (52 at BL; 40 at FUP).|||US Dollars||Standard Deviation|Mean
2601369|NCT02153112|Secondary|Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study|Withdrawal due to an AE will occur if the participant experiences an AE that requires early termination because continued participation imposes an unacceptable risk to the participant's health or the participant is unwilling to continue because of the AE.|Cohort 1: Day 1 up to Day 210; Cohort 2: Day 1 up to Day 293|Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine).|||percentage of participants|||Number
2601370|NCT02153112|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)|Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.|Cohort 1: Day 57; Cohort 2: Day 140|Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.|||ratio||95% Confidence Interval|Geometric Mean
2601371|NCT02153112|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)|Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.|Cohort 1: Day 57; Cohort 2: Day 140|Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.|||ratio||95% Confidence Interval|Geometric Mean
2601728|NCT02150837|Secondary|Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight|The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).|12 weeks||||percentage of subjects|||Number
2601372|NCT02153112|Secondary|Blocking Titers 50 (BT50) of Anti-Norovirus GII.4 VLP Antibody Titers (HBGA)|Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay.|Cohort 1: Day 57; Cohort 2: Day 140|Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.|||titer||95% Confidence Interval|Geometric Mean
2601373|NCT02153112|Secondary|Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)|Blocking titers 50 (BT50) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.|Cohort 1: Day 57; Cohort 2: Day 140|Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.|||titer||95% Confidence Interval|Geometric Mean
2601374|NCT02153112|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)|The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by HBGA binding assay.|Cohort 1: Day 57; Cohort 2: Day 140|Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.|||percentage of participants||95% Confidence Interval|Number
2601375|NCT02153112|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)|The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by HBGA binding assay.|Cohort 1: Day 57; Cohort 2: Day 140|Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.|||percentage of participants||95% Confidence Interval|Number
2601376|NCT02153112|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP (HBGA)|Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by histoblood group antigen (HBGA) binding assay.|Cohort 1: Day 57; Cohort 2: Day 140|Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.|||percentage of participants||95% Confidence Interval|Number
2601377|NCT02153112|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)|Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.|Cohort 1: Day 57; Cohort 2: Day 140|Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.|||ratio||95% Confidence Interval|Number
2601378|NCT02153112|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)|Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.|Cohort 1: Day 57; Cohort 2: Day 140|Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.|||ratio||95% Confidence Interval|Geometric Mean
2601379|NCT02153112|Secondary|Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)|Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA.|Cohort 1: Day 57; Cohort 2: Day 140|Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.|||titer||95% Confidence Interval|Geometric Mean
2601380|NCT02153112|Secondary|Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)|Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA.|Cohort 1: Day 57; Cohort 2: Day 140|Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.|||titer||95% Confidence Interval|Geometric Mean
2601381|NCT02153112|Secondary|Percentage of Participants With a Seroresponse for GII.4 Virus-Like Particle (VLP) (Pan-Ig ELISA)|Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-Like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).|Cohort 1: Day 57; Cohort 2: Day 140|Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.|||percentage of participants||95% Confidence Interval|Number
2601382|NCT02153112|Secondary|Percentage of Participants With a Seroresponse for GI.1 Virus-Like Particle (VLP) (Pan-Ig ELISA)|Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-Like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).|Cohort 1: Day 57; Cohort 2: Day 140|Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Here, overall number of participants analyzed is the number of participants with data available at the given time point.|||percentage of participants||95% Confidence Interval|Number
2601383|NCT02153112|Primary|Percentage of Participants With Serious Adverse Events (SAEs)|A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|Cohort 1: Day 1 up to Day 210; Cohort 2: Day 1 up to Day 293|Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine).|||percentage of participants|||Number
2601384|NCT02153112|Primary|Percentage of Participants With at Least One Unsolicited AE Following Either Vaccination Dose|Unsolicited AEs are any local or systemic AEs, as defined by this study, that are not solicited.|Unsolicited AEs were collected within 28 days of all vaccinations (Day 1 to 57 for Cohort 1 and Day 1 to 140 for Cohort 2)|Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine).|||percentage of participants|||Number
2601385|NCT02153112|Primary|Body Temperature Through Day 7 Following Either Vaccination|Body temperature measurement was performed using the thermometer provided by the site through Day 7 after each vaccination. The highest body temperature observed each day was recorded on the Diary Card. Body temperature is categorized as 1) Any (temperature 38°C or higher), 2) 38°C - <38.5°C, 3) 38.5°C - <39°C, 4) 39°C - <39.5°C, 5) 39.5°C - <40°C, 6) 40°C or higher. Number of participants with the particular body temperature is reported within the pre-defined categories.|Post-vaccination approximately 30 minutes and 6 hours later, then daily through Day 7 after each vaccination given on Days 1, 29, 56 or 112|Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine).|||participants|||Number
2601386|NCT02153112|Primary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination|Systemic AEs are defined as headache, fatigue, myalgia, arthralgia, vomiting (number per day/intensity), and diarrhea (number per day/consistency) for children aged 4 to <9 years; and irritability/fussiness, drowsiness, loss of appetite, vomiting (number per day/intensity), and diarrhea (number per day/consistency) for children aged 6 weeks to <4 years on the day of vaccination and daily through Day 7 after each vaccination.|Days 1 through 7 after each vaccination given on Days 1, 29, 56 or 112|Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine).|||percentage of participants|||Number
2601387|NCT02153112|Primary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 7|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.|Day 7 after either of the vaccination given on Days 1, 29, 56 or 112|Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine). Overall number of participants analyzed is the number of participants with data available at the given time point.|||percentage of participants|||Number
2601388|NCT02153112|Primary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 6|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.|Day 6 after either of the vaccination given on Days 1, 29, 56 or 112|Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine). Overall number of participants analyzed is the number of participants with data available at the given time point.|||percentage of participants|||Number
2601389|NCT02153112|Primary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 5|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.|Day 5 after either of the vaccination given on Days 1, 29, 56 or 112|Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine). Overall number of participants analyzed is the number of participants with data available at the given time point.|||percentage of participants|||Number
2601390|NCT02153112|Primary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 4|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.|Day 4 after either of the vaccination given on Days 1, 29, 56 or 112|Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine). Overall number of participants analyzed is the number of participants with data available at the given time point.|||percentage of participants|||Number
2601391|NCT02153112|Primary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 3|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.|Day 3 after either of the vaccination given on Days 1, 29, 56 or 112|Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine). Overall number of participants analyzed is the number of participants with data available at the given time point.|||percentage of participants|||Number
2601392|NCT02153112|Primary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 2|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.|Day 1 after either of the vaccination given on Days 1, 29, 56 or 112|Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine). Overall number of participants analyzed is the number of participants with data available at the given time point.|||percentage of participants|||Number
2601393|NCT02153112|Primary|Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination on Day 1|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occur on the vaccination day through Day 7 after each vaccination.|Day 1 after either of the vaccination given on Days 1, 29, 56 or 112|Safety analysis set included all participants who received at least 1 dose of vaccine (NoV GI.1/GII.4 bivalent VLP vaccine or control vaccine). Overall number of participants analyzed is the number of participants with data available at the given time point.|||percentage of participants|||Number
2601444|NCT02152384|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve From Time Zero to Last Time (AUC [0 Tlast]) for Paracetamol||Day 29: Pre-breakfast, and 15, 30, 45, 60, 90, 120, 150,180,210,270, and 300 minutes (5 hours) post-breakfast|All participants who received at least 1 dose of study drug and had evaluable PK data.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2601394|NCT02153112|Primary|Percentage of Participants With a Seroresponse (Pan-Ig ELISA) in Cohort 2|Seroresponse was defined as 4-fold rise or greater at Day 140 in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).|Day 140|Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.|||percentage of participants||95% Confidence Interval|Number
2601395|NCT02153112|Primary|Percentage of Participants With a Seroresponse (Pan-Ig ELISA) in Cohort 1|Seroresponse was defined as 4-fold rise or greater at Day 57 in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).|Day 57|Per-protocol set included all participants who received the planned vaccination and do not have major protocol violations. Overall number of participants analyzed is the number of participants with data available at the given time point.|||percentage of participants||95% Confidence Interval|Number
2601396|NCT02153099|Secondary|Terminal Elimination Half-life (T1/2) Pharmacokinetic Parameter for ENV8058 (TAK-058)|Terminal Phase Elimination Half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose|PK population included all enrolled participants.|||hours||Standard Deviation|Mean
2601397|NCT02153099|Secondary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for ENV8058 (TAK-058)|AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.|Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose|PK Population included all enrolled participants.|||ng*hr/mL||Standard Deviation|Mean
2601398|NCT02153099|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ENV8058 (TAK-058)|(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC[0-tlqc]).|Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose|PK Population included all enrolled participants.|||ng*hr/mL||Standard Deviation|Mean
2601399|NCT02153099|Secondary|Cmax: Maximum Observed Plasma Concentration for ENV8058 (TAK-058)|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Predose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours postdose|Pharmacokinetic (PK) Population included all enrolled participants.|||ng/mL||Standard Deviation|Mean
2601400|NCT02153099|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse [beats per minute (bpm)], and resting blood pressure and after standing.|Baseline up to Day 14|Safety population included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2601401|NCT02153099|Primary|Percentage of Participants With Markedly Abnormal Safety Laboratory Tests|The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period.|Baseline up to Day 14|Safety population included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2601402|NCT02153099|Primary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)|Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.|Baseline up to Day 30|Safety population included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2601403|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Physical Condition/Function|"Daytime physical condition/function was defined as general condition of participant throughout the day after adequate or prolonged night time sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants|||Number
2601404|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Somnolence|"Daytime somnolence was defined as excessive daytime sleepiness (EDS), characterized by general lack of energy, even after adequate or prolonged night time sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants|||Number
2601405|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Remaining Tiredness in the Morning|"Remaining tiredness in the morning was defined as an experience of fatigue after complete or adequate sleep duration. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants|||Number
2601406|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Morning Awakening|"Morning awakening was defined as the return to the awaked state from any non-rapid eye movement (NREM) to rapid eye movement (REM) sleep stages in the morning. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants|||Number
2601407|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Quality|"Sleep quality was defined as participants satisfaction of the sleep experience, integrating aspects of sleep initiation, sleep maintenance, sleep quantity, and refreshment upon awakening. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants|||Number
2601408|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Duration|"Sleep duration was defined as the total amount of sleep obtained. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants|||Number
2601409|NCT02153086|Secondary|Percentage of Participants Reported With Improvement on the Patient Global Impression (PGI) Scale for Sleep Onset|"Sleep onset was defined as the transition from wakefulness into sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12)."|At Week 4, 52, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants|||Number
2601410|NCT02153086|Secondary|Sleep Status: Number of Awakenings|Sleep status of participants was assessed and summarized by calculating the number of times participants had awaken from the time of start of the investigation. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).|Baseline, Week 4 and Month 12|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||number of awakenings||Standard Deviation|Mean
2601411|NCT02153086|Secondary|Sleep Status: Total Sleep Time|Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).|Baseline, Week 4 and Month 12|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||hours||Standard Deviation|Mean
2601412|NCT02153086|Secondary|Sleep Status: Sleep Onset Latency|Sleep status was determined by measuring the sleep onset latency, defined as the length of time taken from lying down for the night until sleep onset. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12).|Baseline, Week 4 and Month 12|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||minutes||Standard Deviation|Mean
2601413|NCT02153086|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
2601414|NCT02153073|Primary|Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)||Up to Month 12|Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.|||Participants|||Count of Participants
2601415|NCT02153073|Secondary|Percent Change From Baseline in Lipid Parameters - Non-HDL Cholesterol (Non-HDL-C)|Percent change from baseline in Non-HDL-C values as one of lipid parameters at final assessment point (up to Month 12) was reported.|Baseline, up to 12 months (Final Assessment Point)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure at the given time point.|||Percent change||Standard Deviation|Mean
2601416|NCT02153073|Secondary|Percent Change From Baseline in Lipid Parameters - Total Cholesterol (TC)|Percent change from baseline in TC values as one of lipid parameters at final assessment point (up to Month 12) was reported.|Baseline, up to 12 months (Final Assessment Point)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure at the given time point.|||Percent change||Standard Deviation|Mean
2601417|NCT02153073|Secondary|Percent Change From Baseline in Lipid Parameters -Remnant-Like Particles-Cholesterol (RLP-C)|Percent change from baseline in RLP-C values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported.|Baseline, up to 12 months (Final Assessment Point)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure at the given time point.|||Percent change||Standard Deviation|Mean
2601418|NCT02153073|Secondary|Percent Change From Baseline in Lipid Parameters - Lipoprotein|Percent change from baseline in Lipoprotein values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported.|Baseline, up to 12 months (Final Assessment Point)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure at the given time point.|||Percent change||Standard Deviation|Mean
2601419|NCT02153073|Secondary|Percent Change From Baseline in Lipid Parameters - Apo-CIII|Percent change from baseline in Apo-CIII values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported.|Baseline, up to 12 months (Final Assessment Point)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure at the given time point.|||Percent change||Standard Deviation|Mean
2601420|NCT02153073|Secondary|Percent Change From Baseline in Lipid Parameters - Apo-B|Percent change from baseline in Apo-B values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported.|Baseline, up to 12 months (Final Assessment Point)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure at the given time point.|||Percent change||Standard Deviation|Mean
2601421|NCT02153073|Secondary|Percent Change From Baseline in Lipid Parameters - VLDL Cholesterol (VLDL-C)|Percent change from baseline in VLDL-C values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported.|Baseline, up to 12 months (Final Assessment Point)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.The analyzed numbers were participants who were evaluable for this outcome measure at the given time point.|||Percent change||Standard Deviation|Mean
2601422|NCT02153073|Secondary|Percent Change From Baseline in Lipid Parameters - LDL Cholesterol (LDL-C)|Percent change from baseline in LDL-C values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported.|Baseline, up to 12 months (Final Assessment Point)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure at the given time point.|||Percent change||Standard Deviation|Mean
2601423|NCT02153073|Secondary|Percent Change From Baseline in Lipid Parameters - Triglycerides (TG)|Percent change from baseline in TG values as one of lipid parameters in fasted condition at final assessment point (up to Month 12) was reported.|Baseline, up to 12 months (Final Assessment Point)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure at the given time point.|||Percent change||Standard Deviation|Mean
2601424|NCT02152631|Secondary|Resource Utilization: Percentage of Participants Who Are Hospitalized|Resource utilization is the percentage of participants who was hospitalized.|From Randomization Date through End of Study (Up to 32 Months)|All randomized participants.|||percentage of participants|||Number
2601425|NCT02152631|Secondary|Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Score|There are 5 response levels on a good-to-bad continuum of 1-5 corresponding to none, slight, moderate, severe, and extreme/unable to. The EuroQol-developed crosswalk method was used to convert the EQ-5D-5L,using United Kingdom (UK) weights, health dimensions(mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) into a single index value; the dimensions are not separately scored. The index is marked missing when ≥1 dimensions are missing. The index scores for the response patterns were anchored on full health to dead with negative values assigned to response patterns/health states considered worse than death. The best pattern is assigned the index value of 1.0; the worst pattern is assigned an index value of -0.594. Between-group differences in regression-predicted change from baseline score were estimated for the index. LS Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.|From Randomization Date through End of Study (Up to 32 Months)|All randomized participants who received at least one dose of study drug and with a baseline and at least 1 post-baseline result.|||units on a scale||Standard Error|Least Squares Mean
2601426|NCT02152631|Secondary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval at Steady State|PK is determined by the area under the plasma concentration versus time curve during 1 dosing interval at steady state|Day 1 of Cycle 1 through Cycle 3 (28 Day Cycles)|All randomized participants who received Abemaciclib and had evaluable PK data.|||Hour*nanogram/milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2601445|NCT02152384|Secondary|Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value)|Abbreviation for micro mole per kilogram per minute (µmol/kg/min). Both arms received insulin lispro in addition to their respective study drug. During the euglycemic 2-step hyperinsulinemic clamp, both low and high insulin was infused sequentially during the same procedure. The 2-step clamp procedure allowed insulin sensitivity to be measured in participants and uses a lower dose of insulin of which the effect is largely on the liver and a high dose of insulin at which the effect has reached 100% on liver and effects are largely on glucose uptake in peripheral tissues. Measurements for average glucose infusion rate are collected for both steps (low and high) of the clamp procedure.|Day 35, last 60 minutes of euglycemic 2-step hyperinsulinemic clamp|All participants who received at least 1 dose of study drug and had evaluable PD data.|||µmol/kg/min||Standard Deviation|Mean
2601427|NCT02152631|Secondary|Change From Baseline in MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) Score|The MDASI-LC included 22 items + 3 additional trial-specific items, resulting in 6 collected and reported single-construct scores including core symptoms (13-item), interference (6-item), lung cancer (3-item), and trial-specific single outcomes for headache, diarrhea, and rash. A 2-construct composite core + lung cancer symptom (16-item) score was calculated. Data for all 7 scores were collected by an 11-point numeric rating scale anchored at 0 (not present or does not interfere) and 10 (as bad as you can imagine or interfered completely). The measurement range was 10 (maximum score-minimum score). Mixed Model Repeated Measure (MMRM) regression with covariates for treatment, visit, treatment*visit, and baseline score predicted between-group Least Squares (LS) mean differences from baseline. Group-level negative change from baseline indicated group improvement.|From Randomization Date through End of Study (Up to 32 Months)|All randomized participants for cycles which at least 25% of participants in each arm have a score. MDASI-LC population included all randomized participants who completed at least 1 baseline assessment followed by at least 1 MDASI-LC result.|||units on a scale||Standard Error|Least Squares Mean
2601428|NCT02152631|Secondary|Progression Free Survival (PFS)|PFS defined as the from randomization date to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.|From Randomization Date until Disease Progression or Death from Any Cause (Up to 32 Months)|All randomized participants. 36 participants were censored in the abemaciclib arm and 24 were censored in the erlotinib arm.|||months||95% Confidence Interval|Number
2601429|NCT02152631|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])|ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.|From Randomization Date to Objective Progression (Up to 32 Months)|All randomized participants.|||percentage of participants||95% Confidence Interval|Number
2601430|NCT02152631|Primary|Overall Survival (OS)|OS defined as from randomization date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.|From Randomization Date to Date of Death from Any Cause (Up to 32 Months)|All randomized participants. 81 participants were censored in the Abemaciclib arm and 56 participants were censored in the Erlotinib arm.|||months||95% Confidence Interval|Median
2601431|NCT02152605|Secondary|Change From Baseline (BL) in Mean Number of Puffs of Rescue Medication Per Day Used Over Weeks 1-12|Albuterol/salbutamol(A/S) was used as rescue medication and was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout treatment periods. The number of puffs of rescue medication (A/S) per day over the entire 12 week treatment period was recorded and analyzed. For rescue use, 'day' is referred as the period between one record of rescue use and the next. Total puffs of rescue for each day = number of salbutamol puffs + (2 x number of salbutamol nebules). Analysis performed using mixed model repeated measures with covariates of BL(mean number of total puffs over the duration from First Day; defined as Latest of [7 days before Visit 2 and day after Visit 1] to Last Day(defined as Day before Visit 2)), smoking status, centre group, four-week period, treatment and period by BL interaction. Change from BL used weeks 1-4, 5-8, and 9-12 as covariates in the model and the overall least squares mean change for weeks 1-12 is estimated.|Week 1 amd Week 12|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents all par. in the ITT population without missing covariate information and with at least one post BL measurement.|||puffs per day||Standard Error|Least Squares Mean
2601432|NCT02152605|Secondary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 28, 56 and 84. Baseline is defined as the assessment taken pre-dose on Treatment Day 1. Trough FEV1 is defined as the FEV1 value obtained 24 hours after the previous morning's dosing. Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Liter||Standard Error|Least Squares Mean
2601446|NCT02152384|Secondary|Pharmacokinetics (PK): Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Prandial Insulin Lispro|Abbreviation for hours times picomol per liter (pmol*h/L)|Day 29: Pre-breakfast, and 15, 30, 45, 60, 90, 120, 150,180,210,270, and 300 minutes (5 hours) post-breakfast|All participants who received at least 1 dose of study drug and had evaluable PK data.|||pmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2601447|NCT02152384|Primary|Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro|To quantitate the pharmacodynamic (PD) effect of a range of prandial insulin lispro doses after treatment with insulin peglispro (LY2605541) compared to insulin glargine during a meal tolerance test (MTT), with sequenced doses of insulin lispro ranging from 25% to 150% of each participant's normal dose. Data presented as hours times milligrams per deciliter (mg*h/dL)|Day 30, 31, 32, 33, 34, pre-breakfast and10,20,30,40,50,60,90,120,150,180,210,240,270, 300 minutes (5 hours) post-breakfast|All participants who received at least 1 dose of study drug and had evaluable PD data.|||mg*h/dL||Standard Deviation|Mean
2601433|NCT02152605|Primary|Change From Baseline in Mean St.George's Respiratory Questionnaire (SGRQ) Total Score at Day 84|The SGRQ is a disease-specific questionnaire, self-completed by participants(par), used to evaluate the effect of UMEC/VI on health-related quality of life as compared to placebo in par with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Analysis was performed using mixed model repeated measures with covariates of Baseline (scores recorded prior to dosing on Day 1) SGRQ total score, centre group, smoking status, Day, treatment(trt), Day by Baseline interaction and Day by trt interaction, where Day is nominal. Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Score on scale||Standard Error|Least Squares Mean
2601434|NCT02152566|Primary|Treatment Efficacy|The primary endpoint of the trial is to the efficacy of using nasal high flow therapy to stabilize breathing, as measured by the breath flow signal from PSG.|During 1 night of Sleep on PSG|Out of 6 patient enrolled, 2 withdrew before participating in the study, 1 did not turn up to his appointment. From 3 participants who took part in the study,1 had a positive diagnosis of Cheyne-Stokes Respiration (CSR). The 1 patient who underwent treatment found the device too uncomfortable therefore no outcome measure data were available.||||||
2601435|NCT02152540|Secondary|Mediators of Response|Mediators of response to treatment: to establish a preliminary understanding of the underlying mechanisms related to rTMS modulation of synaptic repair in TBI we will also look at brain-derived neurotrophic factor (BDNF) samples in our population.|6 month follow up||2020-06-30|06/2020||||
2601436|NCT02152540|Secondary|Functional Brain Connectivity|Greater functional connectivity will be observed in hub centers of the Default Mode Network (DMN), particularly the precuneus/posterior cingulate area as measured by resting state fMRI/diffusion tensor imaging (DTI) at follow up compared to baseline in those TBI patients treated with rTMS compared to those treated with sham.|Six month follow-up||2020-06-30|06/2020||||
2601437|NCT02152540|Secondary|Moderators of Response|Moderators of response such as age, severity of symptoms at baseline, time to injury, type of comorbidity, PTSD, sleep depression, substance abuse, medication use, cognitive exercises, fatigue, TBI type, duration of illness, prior treatment resistance (rTMS/ECT) or any combination of these, may affect or moderate the treatment response.|one month||2020-06-30|06/2020||||
2601438|NCT02152540|Secondary|Quality of Life (QOL) Scale|The Veterans RAND 36 Item Health Survey (VR-36©) is a brief, generic, multi-use, self-administered health surveys comprised of 36 items The instruments are primarily used to measure health-related quality of life, to estimate disease burden and to evaluate disease-specific impact on general and selected populations. The items on the questionnaire correspond to eight principal health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue , social functioning and mental health. higher scores mean better health and depicted in percentages. This scale would show significantly greater improvement in patients with mild to moderate TBI who received rTMS treatment.|One month||2020-06-30|06/2020||||
2601439|NCT02152540|Secondary|Sustained Improvement on Executive Function|"At the end of the 6 month post treatment followup TBI patients who received rTMS would be more likely to continue to have greater executive function improvement on Trail making test part B than patients who received Sham rTMS."|6-month post treatment follow up||2020-06-30|06/2020||||
2601440|NCT02152540|Primary|Trail Making Test Part B|"The primary hypothesis is that Veterans receiving active rTMS will show improvement more than sham treated Veterans in performance between baseline and last assessment of >1 SD on the Trail Making Test part B. This test is known for its accurate assessment of executive function in mild and moderate TBI.~The TMT is a timed test and the goal is to complete the test as accurately and as quickly as possible. Raw scores are reported in seconds to complete the test. For Part B, an average score is 75 seconds and a deficient score is greater than 273 seconds.~The present study reports T-scores, which can range from a minimum of 0 and a maximum of 100. The higher the T- score achieved by a participant, the better the performance, indicating a higher level of functioning."|Baseline (up to two weeks after screening visit); Post-Treatment (2 weeks from end of Baseline up to one month from entering the study but always the day of last treatment)||||T-score||Standard Error|Mean
2601441|NCT02152384|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) for Insulin Lispro During Clamp|During the euglycemic 2-step hyperinsulinemic clamp, both low and high insulin was infused sequentially during the same procedure. The 2-step clamp procedure allowed insulin sensitivity to be measured in participants and uses a lower dose of insulin (Low) of which the effect is largely on the liver and a high dose of insulin (high) at which the effect has reached 100% on liver and effects are largely on glucose uptake in peripheral tissues. AUC is taking during infusion for this outcome measure.|Day 35, insulin clearance during lispro infusion (dosing=infusion)|All participants who received at least 1 dose of study drug and had evaluable PK data.|||pmol* hr/L||Standard Deviation|Mean
2601442|NCT02152384|Secondary|Pharmacodynamics (PD): Area Under the Concentration Zero Through 5 Hours (AUC 0-5h) for Triglycerides||Day 29, predose and 15, 30, 45, 60, 90, 120, 150,180,210,270, and 300 minutes (5 hours) post-breakfast|All participants who received at least 1 dose of study drug and had evaluable PD data.|||ng*hr/mL||Standard Deviation|Mean
2601443|NCT02152384|Secondary|Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29|"VAS was scored from 0 - 100 millimeters (mm) as a perception of appetite and satiety (Flint et al. 2000), 0 being not hungry at all or nothing at all and 100 being extremely hungry and extremely large amount.~The questions are abbreviated in table from: How hungry do you feel right now? to Hunger and How much food do you think you could eat right now? to Food amount.~Day 29 and cumulative insulin lispro doses of 25%, 50%, 75%, 100% and 150 % of normal insulin lispro dose included.Scores were averaged will be presented and calculated by a sum of the scores dividing by the total by the number of scores reported for timepoints and reported in millimeters."|Day 29:Upon waking, pre-breakfast, 1 hour (hr), 2 hr, 3 hr, 4 hr and 5 hr post breakfast|All participants who received at least 1 dose of study drug and had VAS score.|||millimeters (mm)||Standard Deviation|Mean
2601448|NCT02152371|Secondary|Rate of Hypoglycemic Events up to 28 Weeks|The rate of total hypoglycemic events any type per 30 days is presented. The hypoglycemia rate per 30 days during defined period is calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days.|Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.|||rate of hypoglycemic events per 30 days||Standard Deviation|Mean
2601449|NCT02152371|Secondary|Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 kg)||28 Weeks|All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline HbA1c data. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values.|||percentage of participants|||Number
2601450|NCT02152371|Secondary|Percentage of Participants Achieving HbA1c Target of <7.0% at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)|Percentage of participants achieving target HbA1c of <7.0% at 28 weeks without documented symptomatic hypoglycemia are presented. Documented symptomatic hypoglycemia is defined as any time a participant experienced symptoms and or signs associated with hypoglycemia and had a plasma glucose of <=70 mg/dL.|28 Weeks|All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline HbA1c data. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values|||percentage of participants|||Number
2601451|NCT02152371|Secondary|Percentage of Participants Achieving HbA1c Target of <7.0% and Without Weight Gain (<0.1 Kilograms [kg]) at 28 Weeks and Without Documented Symptomatic Hypoglycemia During the Maintenance Period (Weeks 12-28)|Percentage of participants who achieved a target HbA1c target of <7%, without weight gain and without documented symptomatic hypoglycemia at 28 weeks were analyzed using regression model, controlling for treatment, pre-treatment, baseline HbA1c and country.|28 Weeks|All randomized participants who received at least 1 dose of study drug and had baseline and post-baseline HbA1c data.Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values.|||percentage of participants|||Number
2601452|NCT02152371|Secondary|Percentage of Participants Achieving HbA1c Targets of <7.0% or ≤6.5%|Percentage of participants who achieved HbA1c levels of <7% or ≤6.5% were analyzed using a logistic regression model, controlling for treatment, pre-treatment, baseline HbA1c and country.|28 Weeks|All randomized participants who received at least 1 dose of study drug and had a baseline and post-baseline HbA1c data. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values.|||percentage of participants|||Number
2601453|NCT02152371|Secondary|Number of Participants With Dulaglutide Anti-Drug Antibodies|Dulaglutide anti-drug antibodies (ADA) were assessed at baseline, Weeks 12 and 28. A participant was considered to have treatment-emergent (TE) dulaglutide ADAs if the participant had at least 1 titer that was TE relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline, Week 12 and Week 28|All randomized participants who received at least 1 dose of study drug and had at least one post-baseline Dulaglutide ADA test result.|||participants|||Number
2601454|NCT02152371|Secondary|Number of Participants With Thyroid Tumors/Neoplasms (Including C-Cell Hyperplasia)||Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2601455|NCT02152371|Secondary|Number of Participants With Adjudicated Acute Pancreatitis Events|The number of cases of acute pancreatitis confirmed by adjudication. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2601456|NCT02152371|Secondary|Percentage of Participants Discontinuing the Study Due to Severe, Persistent Hyperglycemia||Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2601457|NCT02152371|Secondary|Percentage of Participants With Self-Reported Events of Hypoglycemia|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The percentage of participants with self-reported hypoglycemic events is presented.|Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2601458|NCT02152371|Secondary|Number of Participants With Investigator Reported and Adjudicated Cardiovascular Events|Cardiovascular (CV) adverse events (AEs) were adjudicated by an independent committee of physicians with cardiology expertise external to the sponsor. Deaths occurring during the study treatment period and nonfatal CV AEs were to be adjudicated. Nonfatal CV events that were to be adjudicated were myocardial infarction; hospitalization for unstable angina; hospitalization for heart failure; coronary interventions (such as coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI); and cerebrovascular events, including cerebrovascular accident (CVA/stroke), and transient ischemic attack (TIA).|Baseline through 28 Weeks|All randomized participants who received at least 1 dose of study.|||participants|||Number
2601459|NCT02152371|Secondary|Change From Baseline to 28 Weeks in Daily Mean Insulin Glargine Dose|Least Square (LS) Means of the insulin dose change from baseline to primary endpoint at week 28 was adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline insulin dose as covariate, via a MMRM analysis.|Baseline, 28 Weeks|All participants who one dose of study drug and had evaluable baseline and post-baseline insulin glargine data.|||units (u)||Standard Error|Least Squares Mean
2601460|NCT02152371|Secondary|Change From Baseline to 28 Weeks in Body Weight|LS means of the body weight change from baseline to primary endpoint at week 28 was adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline body weight as covariate, via a MMRM analysis.|Baseline, 28 Weeks|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline body weight data.|||kilogram(kg)||Standard Error|Least Squares Mean
2620698|NCT01953328|Secondary|Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2601461|NCT02152371|Secondary|Change From Baseline to 28 Weeks in 7-Point Self Monitored Plasma Glucose (SMPG)|The LS means of the 7-point SMPG change from baseline to primary endpoint at week 28 was measured using a MMRM analysis adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline SMPG as covariate.|Baseline, 28 Weeks|All randomized participants who received at least 1 dose of study drug and had evaluable baseline and post-baseline SMPG data.|||mg/dL||Standard Error|Least Squares Mean
2601462|NCT02152371|Secondary|Change From Baseline to 28 Weeks in Fasting Serum Glucose (FSG)|FSG is a test to determine glucose levels after an overnight fast. LS means FSG change from baseline to primary endpoint at week 28 was calculated using a mixed effects model for repeated measures (MMRM) analysis adjusted by treatment, country, metformin use, week, treatment-by-week interaction, and baseline FSG as covariate.|Baseline, 28 Weeks|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline FSG data.|||milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
2601463|NCT02152371|Primary|Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c)|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least-squares (LS) mean and standard error (SE) changes from baseline in HbA1c at 28 weeks were measured using mixed model regression and restricted maximum likelihood (REML) with treatment, pooled country, visit, and treatment-by -visit interaction as fixed effects, baseline as covariate, and participant as a random effect.|Baseline, 28 Weeks|All participants who received at least one dose of study drug and had evaluable baseline and post- baseline HbA1c.|||percentage of change||Standard Error|Least Squares Mean
2601464|NCT02152345|Secondary|Estimated Glomerular Filtration Rate (eGFR)|Estimated glomerular filtration rate (eGFR) is based on a blood sample (serum creatinine value), age, race, and gender. eGFR estimates best the function of the kidney at any one time.|Up to 1 year post-transplantation||||mL/min/1.73m^2||Standard Deviation|Mean
2601465|NCT02152345|Secondary|Number of Participants With an Allograft Rejection Episode|All rejection episodes will be confirmed by renal transplant biopsy provoked by change in renal function not explained by other clinical causes.|Up to 1 year post-transplantation||||Participants|||Count of Participants
2601466|NCT02152345|Secondary|Percentage of Participants With Allograft Survival|Allograft survival is defined as functioning renal transplant.|Up to 1 year post-transplantation||||Participants|||Count of Participants
2601467|NCT02152345|Primary|Delayed Graft Function (DGF) Rate|"To assess whether treatment with Thymoglobulin induction and belatacept based maintenance immunosuppression would reduce delayed graft function (DGF) rates among recipients of deceased donor renal transplants as measured by clinical findings and NGAL marker, as specified below and defined by others. This will be compared to the incidence of DGF in patients treated with a Tacrolimus based regimen.~Patients who require hemodialysis in the first 7 days after transplantation and/or patients whose serum creatinine decreases <10% during 3 consecutive days after the transplant will be considered to have DGF in the absence of other confounding factors such as obstruction or infection. NGAL will be used as a verification marker of DGF."|Up to 3 months post-transplantation||||Participants|||Count of Participants
2601468|NCT02152137|Secondary|Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0|The number of patients who experienced at least one grade 3 or higher adverse event is reported below.|Up to 5 years|Patients who received efatutazone and paclitaxel combination were included in this analysis.|||Participants|||Count of Participants
2601469|NCT02152137|Secondary|PFS Determined Based on RECIST 1.1 Criteria|Progression free survival (PFS) is defined as the time from the date of registration to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|The time from study entry to the first of either disease progression or death from any cause, assessed up to 5 years|Patients who received efatutazone and paclitaxel combination were included in this analysis.|||months||95% Confidence Interval|Median
2601470|NCT02152137|Secondary|Duration of Confirmed Response|Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir).|The time from the first documented date of confirmed response (CR or PR) to date at which progression is first documented, assessed up to 5 years|Only patients who achieved a confirmed response are included in this analysis.|||months|||Number
2601471|NCT02152137|Secondary|Overall Survival|Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Time from study entry to death from any cause, assessed up to 5 years|Patients who received efatutazone and paclitaxel combination were included in this analysis.|||months||95% Confidence Interval|Median
2601472|NCT02152137|Primary|Confirmed Response Rate (Partial Response [PR] or Complete Response [CR]) Per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 Criteria|The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.|Up to 24 weeks|Patients who received efatutazone and paclitaxel combination were included in this analysis.|||percentage of patients||95% Confidence Interval|Number
2601473|NCT02152007|Other Pre-specified|Standardized Photographs|An expert in the disease who is blinded to the study treatment will read the photographs of the callus area taken at each study visit. The reader will assess changes to the calluses based on criteria such as blisters, cracks, small/large size, and red or bloody spots on the callus. Change in calluses will be reported for both the right and left foot.|Each study visit over 39 weeks|||||||
2602966|NCT02137512|Secondary|Glucose Standard Deviation - Main Phase, Day Only|CGM Glucose Standard Deviation (SD) during study Main Phase, day only (07:00 - 23:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||mg/dL||Inter-Quartile Range|Median
2601474|NCT02152007|Other Pre-specified|Investigator Assessment of Local Tolerability|Investigator assessment of local tolerability at the application sites on the plantar surfaces will be evaluated by the Investigator according to a 4-point scale (0, 1, 2, or 3; none to severe) with regard to: erythema, pruritis, stinging/burning, and crusting/erosion|Prior to application of study drug and within 15-45 minutes after application of study drug at each visit for 39 weeks||||units on a scale||Standard Deviation|Mean
2601475|NCT02152007|Secondary|Daily Assessments Recording in the PC Measurement Diary||Weekly for 39 weeks|||||||
2601476|NCT02152007|Secondary|Weekly Assessments Recorded in the PC Quality of Life Index|Patient-reported weekly assessment in the PC Quality of Life Index|Weekly for 39 weeks|||||||
2601477|NCT02152007|Primary|Evaluation of Systemic Absorption Through Measurement of Serum Sirolimus Trough Levels|The primary outcome measure for this Phase 1b safety study is evaluation of system absorption through measurement of serum sirolimus trough levels. The limit of detection of the assay was 2.0 ng/mL.|Two weeks and every 1-2 months for 24 weeks or within 2 weeks after the last dose of study drug|Starting at week 13, visit 4, there were only 14 participants with available data.|||participants|||Number
2601478|NCT02151994|Primary|Percentage (%) of Subjects With Treatment-Emergent Adverse Event (TEAE) Related to Study Medication (SM) - Food Effect (FE)|"Just before drug administration and twice daily until 72 h after (last) drug administration, subjects were asked non-leading questions to determine the occurrence of AEs. Subjects were asked in general terms about any AEs at regular intervals during each study period. In addition, all AEs reported spontaneously during the course of the study were recorded. All answers were assessed by the Medical Investigator (MI), coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 14.0) and recorded in the AEs Record. The intensity of the AEs was rated as mild, moderate or severe and the relationship between the AEs and the study medication was indicated as not related, unlikely, possible, probable or ''definite."|Just before drug administration and twice daily until 72 h after (last) drug administration||||% of subject with TEAEs related to SM|||Number
2601479|NCT02151994|Primary|Percentage (%) of Subjects With Treatment-Emergent Adverse Event (TEAE) Related to Study Medication (SM) - Multiple Ascending Dose (MAD) Period|"Just before drug administration and twice daily until 72 h after (last) drug administration, subjects were asked non-leading questions to determine the occurrence of AEs. Subjects were asked in general terms about any AEs at regular intervals during each study period. In addition, all AEs reported spontaneously during the course of the study were recorded. All answers were assessed by the Medical Investigator (MI), coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 14.0) and recorded in the AEs Record. The intensity of the AEs was rated as mild, moderate or severe and the relationship between the AEs and the study medication was indicated as not related, unlikely, possible, probable or ''definite."|Just before drug administration and twice daily until 72 h after (last) drug administration|No drug-related TEAEs were reported for the dose levels of 50 mg md and 400 mg md.|||% of subject with TEAEs related to SM|||Number
2601480|NCT02151994|Primary|Percentage (%) of Subjects With Treatment-Emergent Adverse Event (TEAE) Related to Study Medication (SM) - Single Ascending Dose (SAD) Period|"Just before drug administration and twice daily until 72 h after (last) drug administration, subjects were asked non-leading questions to determine the occurrence of AEs. Subjects were asked in general terms about any AEs at regular intervals during each study period. In addition, all AEs reported spontaneously during the course of the study were recorded. All answers were assessed by the Medical Investigator (MI), coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 14.0) and recorded in the AEs Record. The intensity of the AEs was rated as mild, moderate or severe and the relationship between the AEs and the study medication was indicated as not related, unlikely, possible, probable or ''definite."|Just before drug administration and twice daily until 72 h after (last) drug administration||||% of subject with TEAEs related to SM|||Number
2601481|NCT02151981|Other Pre-specified|Number of Deaths|Total number of deaths at the time of the analysis|From randomisation until death, up to 19 months (at the time of analysis).|Full Analysis Set (all randomised patients)|||Number of participants|||Number
2601482|NCT02151981|Secondary|Tumour Shrinkage by Investigator Assessment|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Tumour size was calculated as the sum of the longest diameters (SLD) of the Target Lesions. Tumour shrinkage is percentage change in tumour size from baseline using RECIST v1.1 tumour response.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of analysis).|Full Analysis Set (All randomised patients)|||% change from baseline||Standard Deviation|Mean
2601483|NCT02151981|Secondary|Disease Control Rate (DCR) by Investigator Assessment|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. DCR is the percentage of patients with best response of CR, PR or SD at >=6 weeks, prior to any progressive disease (PD).|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of analysis).|Full Analysis Set (All randomised patients)|||% of participants|||Number
2601484|NCT02151981|Secondary|Duration of Response (DoR) by Investigator Assessment|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR is the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of analysis).|Full Analysis Set (All randomised patients)|||months||95% Confidence Interval|Median
2601571|NCT02151448|Secondary|Overall Survival (OS)|The length of time from the start of treatment that diagnosed patients are still alive.|Up to 5 years|Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery.|||months||95% Confidence Interval|Median
2601485|NCT02151981|Secondary|Objective Response Rate (ORR) by Investigator Assessment|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR prior to progression or any further therapy.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of analysis).|Full Analysis Set (All randomised patients)|||% of participants|||Number
2601486|NCT02151981|Primary|Progression Free Survival (PFS) by Investigator Assessment|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of randomisation until the date of PD (by investigator assessment) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression up to 19 months (at the time of analysis).|Full Analysis Set (All randomised patients)|||Months|Events|95% Confidence Interval|Median
2601487|NCT02151877|Other Pre-specified|Surgical Morbidity|include all complications that may happen after cardiac surgery for the whole period of hospital stay, that is expected to be around 1 month. This include renal failure, prolonged intubation and ventilatory support, infections..|1 month after cardiac surgery|Intent to treat|||Participants|||Count of Participants
2601488|NCT02151877|Secondary|Length of Intubation and PSHU Stay|Days to extubation and Pediatric Surgical Heart Unit (PSHU) length of stay (LOS) as measuring patient surgical outcomes.|Surgery to discharge|ITT|||days||Inter-Quartile Range|Median
2601489|NCT02151877|Secondary|Inotropic Score Day 1|"The Inotropic Score is an objective clinical tool used to quantify the need for cardiovascular support in children and adolescents after surgery and to predict prognosis of pediatric septic shock (higher score predicts higher risk or worse prognosis).The Inotropic Score is low if <= 20, intermediate if 21-30, and high if > 30.~Formula used in the study:~Daily inotropic score (mcg/kg/min) = Dopamine drip dose+ dobutamine drip dose+ (milrinone drip dose times 10) + (epinephrine drip dose times 100 )"|24 hours post surgery|ITT|||mcg/kg/min||Inter-Quartile Range|Median
2601490|NCT02151877|Secondary|Time Until Start of Diuretic Therapy|hours until start of diuretic therapy|Pre-op to 72 hours post surgery|Intent to treat|||hour||Inter-Quartile Range|Median
2601491|NCT02151877|Secondary|Total Fluid Balance at 48 Hours|The secondary study endpoints are to evaluate whether NO delivered through the neonatal CPB circuit can decrease the clinical signs of ischemia/reperfusion injury and/or cardiac dysfunction. Clinical parameters (post surgery) include inotropic support, fluid balances, diuretic support, ventilator times, and length of ICU stay will be evaluated.|48 hours post surgery|Intent to treat|||ml/kg||Inter-Quartile Range|Median
2601492|NCT02151877|Primary|Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op)|The primary study endpoints are to evaluate whether NO delivered through the neonatal cardiopulmonary bypass (CPB) circuit can decrease various biochemical markers of ischemia/reperfusion injury and oxidative damage. Markers to be analyzed will include cardiac troponin I, interleukins (IL), tumor necrosis factor, N-terminal prohormone for brain natriuretic peptide (NT-proBNP),lactate dehydrogenase (LDH), plasma anti-oxidant levels, plasma malondialdehyde (MDA) levels.|Pre-op baseline and up to 12 hours after surgery|Intent to treat (ITT)|||ng/ml||Standard Deviation|Mean
2601493|NCT02151851|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24|The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. Each domain consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3. A total score is computed from the item scores using the scoring rules provided by the index's author. HAQ-DI scores range from 0 to 3. Lower scores indicate less disability. Negative values indicate improvement from Baseline.|Baseline, Week 24|"The Full Analysis Set (FAS) consisted of all randomized subjects who received at least 1 dose of study medication administration and provided any efficacy data after the first administration.~LOCF = last observation carried forward. Only subjects with available HAQ-DI scores at week 24 were included."|||units on a scale||Standard Deviation|Mean
2601494|NCT02151851|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 24|The assessments are based on a 70 % or greater improvement from Baseline to Week 24 in the number of tender joints, in the number of swollen joints, and a 70 % or greater improvement in at least 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|Week 24|"The Full Analysis Set (FAS) consisted of all randomized subjects who received at least 1 dose of study medication administration and provided any efficacy data after the first administration.~NRI = non-responder imputation."|||percentage of participants|||Number
2601495|NCT02151851|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 24|The assessments are based on a 50 % or greater improvement from Baseline to Week 24 in the number of tender joints, in the number of swollen joints, and a 50 % or greater improvement in at least 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|Week 24|"The Full Analysis Set (FAS) consisted of all randomized subjects who received at least 1 dose of study medication administration and provided any efficacy data after the first administration.~NRI = non-responder imputation."|||percentage of participants|||Number
2601594|NCT02151331|Primary|Reduced Mood Disorder Symptoms|Mood disorder symptoms were measured using the Patient Health Questionnaire (9-question). The PHQ-9 has a scale range of 0-27 with lower values representing better outcomes.|Change from Baseline in Mood Disorder Symptoms at 12-months||||score on a scale||95% Confidence Interval|Mean
2601496|NCT02151851|Primary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 24|The assessments are based on a 20 % or greater improvement from Baseline to Week 24 in the number of tender joints, in the number of swollen joints, and a 20 % or greater improvement in at least 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|Week 24|"The Full Analysis Set (FAS) consisted of all randomized subjects who received at least 1 dose of study medication administration and provided any efficacy data after the first administration.~NRI = non-responder imputation."|||percentage of participants|||Number
2601497|NCT02151786|Secondary|Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment|Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.|Week 8 after the last dose of study drug (Week 17)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
2601498|NCT02151786|Secondary|Percentage of Participants With Observed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment|Rebleeding rate was reported as percentage of participants who experienced rebleeding after observed hemostasis and was calculated at 8 weeks after the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with observed hemostasis.|Week 8 after the last dose of study drug (Week 17)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
2601499|NCT02151786|Secondary|Percentage of Participants Who Experienced Rebleeding After Confirmed Hemostatic Effect|Rebleeding rate was reported as percentage of participants who experienced rebleeding after confirmed hemostasis by endoscopy and was calculated during the period starting from baseline until the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with confirmed hemostasis.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
2601500|NCT02151786|Secondary|Percentage of Participants Who Experienced Rebleeding After Observed Hemostatic Effect|Rebleeding rate was reported as percentage of participants who experienced rebleeding after observed hemostasis and was calculated during the period starting from baseline until the completion of treatment with lansoprazole. It was calculated by dividing the percentage of the number of participants who experienced rebleeding after hemostasis divided by the total number of participants with observed hemostasis.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
2601501|NCT02151786|Secondary|Percentage of Participants With Confirmed Hemostatic Effect|Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with confirmed hemostatic effect by endoscopy. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with confirmed hemostatic effect.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
2601502|NCT02151786|Secondary|Percentage of Participants With Observed Hemostatic Effect|Hemostatic effect was categorized on the basis of degree of improvement as: markedly improved, moderately improved, slightly improved and poor in the participants with observed hemostatic effect. Efficacy rate was reported as percentage of participants showing efficacy and was calculated as the sum of percentage of number of participants reporting markedly improved + moderately improved + slightly improved divided by the percentage of total number of participants with observed hemostatic effect.|Baseline up to Week 9|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
2601503|NCT02151786|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to Week 9|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
2601504|NCT02151786|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to Week 9|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
2601505|NCT02151773|Secondary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to Day 28|Safety analysis set included all participants who received at least one dose of study vaccination.|||participants|||Number
2601506|NCT02151773|Primary|Number of Participants With Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Frequency of adverse events and factors that may influence safety were not to be assessed as endpoints of this study and were registered as endpoints by mistake. Instead, adverse drug reactions were assessed as endpoint.|Baseline up to Day 28|Safety analysis set included all participants who received at least one dose of study vaccination.|||participants|||Number
2601507|NCT02151682|Other Pre-specified|Time to First Intake of Rescue Medication in the Open-label, Active-controlled Treatment Period (Part 1)|"Morphine oral solution could be given during Part 1 as rescue medication in both treatment groups. The dose per rescue medication intake was 1/6 of the total daily dose of the scheduled tapentadol or morphine PR intakes. Rescue medication administration times and doses were recorded.~18 Participants in the morphine PR group and 27 participants in the tapentadol PR group had no documented intake of rescue medication between Day 1 and Day 14.~Summary statistics were calculated based on participants with any intake, i.e., those that took at least 1 dose of rescue medication. The mean (standard deviation) time (hours) to first dose of rescue medication following the first dose of the IMP (on Day 1) is presented."|From Day 1 up to Day 14 (End of Part 1)|Full Analysis Set|||hours||Standard Deviation|Mean
2601508|NCT02151682|Other Pre-specified|Time to Discontinuation (Treatment Emergent Adverse Events) in Part 2|The time to discontinuation from IMP due to treatment emergent adverse events (TEAEs) was analyzed for tapentadol PR treatment in Part 2 of the study.|From first day in Part 2 (Day 15) to last day in Part 2 (Day 379)|Safety Set; 3 participants discontinued due to treatment emergent adverse events.|||weeks||Full Range|Mean
2601509|NCT02151682|Other Pre-specified|Time to Discontinuation (Treatment Emergent Adverse Events) in Part 1|"The time to discontinuation from IMP due to treatment emergent adverse events (TEAEs) was analyzed for both treatment arms (tapentadol PR and morphine PR) in Part 1 of the study.~Note that no participant discontinued due to a TEAE in the morphine PR arm, and 2 participants in the tapentadol PR arm."|From first day in Part 1 (Day 1) to last day in Part 1 (Day 14)||||days||Full Range|Mean
2601510|NCT02151682|Other Pre-specified|Time to Discontinuation (Lack of Efficacy) in Part 2|The time to discontinuation from IMP due to lack of efficacy was analyzed for tapentadol PR treatment in Part 2 of the trial.|From first day in Part 2 (Day 15) to last day in Part 2 (Day 379)|Safety Set; 3 participants with early discontinuation from IMP due to lack of efficacy|||weeks||Full Range|Mean
2601511|NCT02151682|Other Pre-specified|Time to Discontinuation (Lack of Efficacy) in Part 1|The time to discontinuation from IMP due to lack of efficacy was planned to be analyzed for both treatment arms (tapentadol PR and morphine PR) in Part 1 of the trial. However, no participant was reported with early discontinuation from IMP due to lack of efficacy. Consequently, no time to discontinuation can be reported.|From first day in Part 1 (Day 1) to last day in Part 1|||||||
2601512|NCT02151682|Other Pre-specified|Change From Baseline in Subjective Opiate Withdrawal Scale (SOWS)|"Opiate withdrawal symptoms were assessed using the Subjective Opiate Withdrawal Scale (SOWS) questionnaire. The SOWS is designed to reflect common motoric, autonomic, musculoskeletal, and psychic signs and symptoms of opiate withdrawal. Each participant was requested to rate the first 15 items of the 16-item questionnaire for 7 days after last IMP intake. Participants rated the intensity of specific signs and symptoms on a scale of 0 (not at all) to 4 (extremely). The minimum overall score is 0, the maximum score is 64.~SOWS Total Score at baseline (i.e., for Part 1 = Day 14-17, for Part 2 = Day 352-380, or the day after an early termination visit (Part 1/2)), and changes from baseline 2-7 days after last intake of IMP in Part 1 (= up to Day 23) and in Part 2 (= up to Day 386) are presented."|From Day 1 to Day 386 (End of Part 2 + 7 days)|Safety Set|||units on a scale||Standard Deviation|Mean
2601513|NCT02151682|Other Pre-specified|Extent of Constipation (Part 2)|"Constipation was assessed using the modified constipation assessment scale (mCAS). This is an 8-item questionnaire where the observer has scored constipation on a nominal scale (no problem [score 0], some problem [score 1] or severe problem [score 2]). The response to an item could also be scored as unable to assess.~The Total Score can vary from 0-16; the higher the Total Score the higher the extent of constipation. A positive change from baseline to last assessment indicates a worsening, a negative change an improvement."|From baseline (Day 15 or switch) to last assessment (up to Day 379 of Part 2)|Safety Set|||units on a scale||Standard Deviation|Mean
2601514|NCT02151682|Other Pre-specified|Acceptability of Study Medication (Part 1, Day 14)|"Acceptability of the study medication was determined in Part 1 by asking the participant Swallowing the medication is.... The participant was requested to give a score on a 5-point hedonic faces rating scale in combination with a verbal rating. The response can range from really difficult to really easy."|Day 14 (End of Part 1)|Full Analysis Set|||Participants|||Count of Participants
2601515|NCT02151682|Other Pre-specified|Acceptability of Study Medication (Part 1, Day 8)|"Acceptability of the study medication was determined in Part 1 by asking the participant Swallowing the medication is.... The participant was requested to give a score on a 5-point hedonic faces rating scale in combination with a verbal rating. The response can range from really difficult to really easy."|Day 8 (Part 1)|Full Analysis Set|||Participants|||Count of Participants
2601516|NCT02151682|Other Pre-specified|Palatability of Study Medication (Part 1, Day 14)|"Palatability was determined in Part 1 by asking the participant How does the medication taste. The participant was requested to give a score on a 5-point hedonic faces rating scale in combination with a verbal rating. The response can range from really bad to really good."|Day 14 (Part 1)|Full Analysis Set|||Participants|||Count of Participants
2601517|NCT02151682|Other Pre-specified|Palatability of Study Medication (Part 1, Day 8)|"Palatability was determined in Part 1 by asking the participant How does the medication taste. The participant was requested to give a score on a 5-point hedonic faces rating scale in combination with a verbal rating. The response can range from really bad to really good."|Day 8 (Part 1)|Full Analysis Set|||Participants|||Count of Participants
2601595|NCT02151331|Primary|Health-related Quality of Life - Mental Health Component Score|Mental Health Quality of Life was measured using the 12-Item Short Form Survey (SF-12). The SF-12 has a scale range of 0-100 with higher values representing better outcomes.|Change from Baseline in Quality of Life at 12-months||||score on a scale||95% Confidence Interval|Mean
2601518|NCT02151682|Other Pre-specified|Serum Concentrations of Tapentadol-O-glucuronide (Part 1)|"Tapentadol-O-glucuronide is a metabolite of tapentadol. The body transforms tapentadol into its metabolites so that it can be more easily/quickly removed from the body. Tapentadol-O-glucuronide serum concentrations were measured in participants who received tapentadol PR in Part 1.~All participants who had quantifiable serum concentrations were included in the descriptive pharmacokinetic analysis. Data from participants who vomited within 6 hours of administration of IMP during Part 1 were carefully assessed to decide if they should be included in the pharmacokinetic analysis."|From Day 1 to Day 14 (End of Part1)|Pharmacokinetic Analysis Set|||nanograms per milliliter||Standard Deviation|Mean
2601519|NCT02151682|Other Pre-specified|Serum Concentrations of Tapentadol (Part 1)|"Tapentadol serum concentrations were measured in participants in the tapentadol treatment arm (Part 1).~All participants who had quantifiable serum concentrations during the Treatment Period were included in the descriptive pharmacokinetic analysis. Data from participants who vomited within 6 hours of administration of IMP during the Treatment Period were carefully assessed to decide if the data should be included in the pharmacokinetic analysis."|From Day 1 to Day 14 (End of Part 1)|Pharmacokinetic Analysis Set|||nanograms per milliliter||Standard Deviation|Mean
2601520|NCT02151682|Other Pre-specified|Use of Rescue Medication in the Open-Label, Active-controlled Treatment Period (Part 1)|"Due to an overall low intake of rescue medication, it was not appropriate to present the number of doses of oral morphine solution used at different dose levels of investigational medicinal product (IMP) but the average daily dose (milligrams per kilogram body weight) for the treatment period and a modified average daily dose. Average daily dose and modified average daily dose were both calculated based on drug accountability.~For the modified average daily doses, implausible values were excluded from the analysis, i.e., the amount of rescue medication that was lost due to a broken bottle was excluded from the analysis and negative amounts of rescue medication intakes due to measurement inaccuracies for bottle weights were considered as no intake."|From Day 1 up to Day 14 (End of Part 1)|Full Analysis Set|||milligrams per kilogram per day||Standard Deviation|Mean
2601521|NCT02151682|Other Pre-specified|Change in Pain Intensity in the Tapentadol Open-label Extension Period (Part 2)|"Pain intensity was assessed by scoring Pain right now using the Visual Analog Scale (VAS) as well as the Faces Pain Scale-Revised (FPS-R) at each visit. The pain intensity was first documented using the VAS and directly thereafter the FPS-R. If required, pain intensity assessments could be assisted by the legal guardian or a health care provider.~The VAS is scored from 0, equivalent to no pain, to 100, equivalent to pain as bad as it could be. The FPS-R is a validated self-reported 6-point scale with 0 representing no pain and 10 representing very much pain. Facial representations were used to indicate how much the pain hurts.~The pain right now score at the tapentadol baseline (last evaluation before or at Day 15) and at the last assessment for those subjects who completed the 12 months treatment of Part 2 were used for the calculation of the change in pain intensity from the tapentadol baseline."|From Day 15 to Day 379 (End of Part 2)|Full Analysis Set; data from 9 subjects who completed the visit 12 months after start of Part 2 were analyzed.|||units on a scale||Standard Deviation|Mean
2601522|NCT02151682|Other Pre-specified|Change in Pain Intensity in the Open-label, Active-controlled Treatment Period (Part 1)|"Pain intensity was assessed by scoring Pain right now twice daily up to Day 14 by every participant using the Visual Analog Scale (VAS) as well as the Faces Pain Scale-Revised (FPS-R) in an electronic diary. Pain intensity was first documented using the VAS and directly thereafter the FPS-R. If required, pain intensity diary entry could be assisted by the legal guardian or a health care provider.~The VAS is scored from 0, equivalent to no pain, to 100, equivalent to pain as bad as it could be.~The FPS-R is a validated self-reported 6-point scale with 0 representing no pain and 10 representing very much pain. Facial representations were used to indicate how much the pain hurts.~The pain right now scores at baseline (last evaluation before starting IMP) and the mean of last 6 assessments collected up to the time point of last IMP intake in Part 1 (i.e., Day 14 or the day of early discontinuation) were used for the calculation of the change in pain intensity from baseline."|From Baseline up to Day 14 (End of Part 1) or early discontinuation|Full Analysis Set|||units on a scale||Standard Deviation|Mean
2601523|NCT02151682|Secondary|Tolerability Over the Complete Trial Period|"Tolerability was assessed by the number of participants with exactly 1 to more than 5 treatment emergent adverse events (TEAE) by treatment group during the different trial periods, on a participant level.~In addition, tolerability was assessed by the number of participants with TEAEs which were considered by the investigator to be at least possibly related to the treatment the participant received."|Part 1: Day 1 (Start of Part 1) to Day 14; Part 2: Day 15 to Day 379 (End of Part 2)|Safety Set|||participants|||Number
2601524|NCT02151682|Secondary|Extent of Constipation (Part 1)|"Constipation was assessed using the modified constipation assessment scale (mCAS). This is an 8-item questionnaire where the observer has scored constipation on a nominal scale (no Problem [score 0], some problem [score 1] or severe Problem [score 2]). The response to an item could also be scored as unable to assess.~The Total Score can vary from 0-16; the higher the Total Score the higher the extent of constipation. A positive change from Day 1 to Day 14 indicates a worsening, a negative change an improvement."|From Day 1 to Day 14 (End of Part 1)|Safety Set|||score on a scale||Standard Deviation|Mean
2601525|NCT02151682|Primary|Number of Participants Classified as Responder (Part 1)|"The proportion of participants classified as responders was assessed and compared between the treatment groups.~A participant was defined as responder if both of the following criteria were met:~Completion of the 14-day Treatment Period (Part 1).~One of the following calculated from the scheduled pain assessments (pain right now) documented during the last 3 days of the Treatment Period:~Average pain less than 50 on a visual analog scale (VAS, range 0 [no pain] to 100 [pain as bad as it could be]) for participants aged 12 years to less than 18 years; or less than 5 on the Faces Pain Scale-revised (FPS-R, range 0 [no pain] and 10 [very much pain]) for participants aged 6 years to less than 12 years.~Average reduction from baseline of pain greater than or equal to 20 on a VAS for participants aged 12 years to less than 18 years; or greater than or equal to 2 on the FPS-R for participants aged 6 years to less than 12 years."|From Day 1 up to Day 14 (End of Part 1)|Full Analysis Set; missing pain assessments (last 3 days) were imputed using multiple imputation.|||Participants|||Count of Participants
2601647|NCT02150863|Primary|Count of the Number of Actinic Keratosis and Non Melanoma Skin Cancers in the Treatment Area|This is done at every visit over the 3 year period|Entire study period (3 years)|Zero participants were analyzed because no patients finished this study. Patient recruitment was very difficult for this study, and therefore the study ended prematurely.||||||
2601526|NCT02151643|Secondary|Change in Gastrointestinal Symptom Rating System (GSRS) Overall Score From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)|The GSRS assesses the impact of treatment-related GI complications. It includes 15 items divided into 5 subscales (diarrhoea, indigestion, abdominal pain, constipation, and reflux), and uses a seven-grade Likert scale to assess symptoms (1 = no discomfort at all, 7 = very severe discomfort). The total score was calculated as the average score of all 15 items. If data were missing from one or more subscales, the mean of the completed items within the subscale was to be used for the subscale score, provided that more than half of the subscale items were complete. If more than half of the items within a subscale were missing, the subscale score and overall score were also to be defined as missing. The change in overall GSRS score from Baseline (Visit 7, Day 1) to Visit 11 (Day 29) was summarised by treatment and a two-sample t-test was to be used to identify differences between the placebo and PT20 dose groups. The higher the score, the more severe the gastrointestinal symptoms.|Day 1 to Day 29|Safety Set|||score on a scale||Standard Deviation|Mean
2601527|NCT02151643|Secondary|Change in Calcium x Phosphate Product From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)|Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in Calcium x Phosphate Product . An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Day 29 (Visit 11), which were to include the fixed, categorical effects of treatment, as well as the continuous, fixed covariates of Baseline concentrations for Calcium x Phosphate Product. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. In CKD subjects (Stages 3-5), the clinical recommendation (KDOQI) is that serum calcium x phosphate product should be maintained at < 55 mg^2/dL^2 (4.4 mmol^2 /L^2).|Day 1 to Day 29|ITT population.|||mg^2/dL^2||Standard Deviation|Mean
2601528|NCT02151643|Secondary|Change in Transferrin Saturation From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)|Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in transferrin saturation. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Day 29 (Visit 11), which were to include the fixed, categorical effects of treatment and week, as well as the continuous, fixed covariates of Baseline concentrations for transferrin saturation. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis.|Day 1 to Day 29|ITT population.|||percent||Standard Deviation|Mean
2601529|NCT02151643|Secondary|Change in Serum Ferritin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)|Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in serum ferritin concentration. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Visit 11 (Day 29), which were to include the fixed, categorical effects of treatment and week (Visit), as well as the continuous, fixed covariates of Baseline concentrations for serum ferritin. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis.|Day 1 to Day 29|ITT population.|||ng/mL||Standard Deviation|Mean
2601530|NCT02151643|Secondary|Change in Haemoglobin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)|Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in haemoglobin concentration. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Visit 11 (Day 29), which were to include the fixed, categorical effects of treatment as well as the continuous, fixed covariates of Baseline concentrations for haemoglobin. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis.|Day 1 to Day 29|ITT population.|||g/dL||Standard Deviation|Mean
2601531|NCT02151643|Primary|Change in Serum Phosphate Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)|The primary efficacy endpoint was the change in serum phosphate concentration from Baseline (Visit 7, Day 1) to Visit 11 (Day 29). All study specific blood samples were collected, processed and analysed using a central laboratory.|Day 1 to Day 29|Intent-to-Treat (ITT) population.|||mg/dL||Full Range|Mean
2601532|NCT02151591|Secondary|Number of Participants Who Completed Treatment.|To assess feasibility/acceptability, the number of participants who completed treatment will be assessed.|12 weeks|Number of participants who completed treatment.|||Participants|||Count of Participants
2601533|NCT02151591|Secondary|Log Transformed Percentage of Heavy Drinking Days|Log transformed percentage of heavy drinking days 6 months post treatment start.|6 months post treatment start||||Mean log transformed percentage score||Standard Error|Mean
2601534|NCT02151591|Primary|Number of Participants With Smoking Abstinence at 6 Months|Number of participants with point prevalence smoking abstinence (i.e., no smoking, not even a puff over the last 7 days) 6 months after treatment completion.|6 months post treatment start|Number of participants with smoking abstinence at 6 months|||Participants|||Count of Participants
2601535|NCT02151526|Secondary|Vector Copy Number (VCN) in Peripheral Blood|LentiGlobin BB305 lentiviral vector (LVV) transduction efficiency was measured by VCN. The presence of vector sequences in the genomic DNA of cells is detected using quantitative polymerase chain reaction (qPCR), and results were expressed as VCN.|From time of drug product infusion through Month 24|This outcome measure was evaluated in the Transplant Population (TP).|||copies per diploid genome (c/dg)||Standard Deviation|Mean
2601536|NCT02151526|Secondary|Therapeutic Globin Expression Measured by Hb Containing β^A -T87Q Globin (HbA^T87Q) in Peripheral Blood|Therapeutic globin expression was measured by HbA^T87Q in peripheral blood and the ratio of alpha(α)- globin to all beta (β)-like-globins. The relative amount of each globin produced by a participant (including βA^A-T87Q globin) was determined in peripheral blood throughout the study.|From time of drug product infusion through Month 24|This outcome measure was evaluated in the Transplant Population (TP).|||grams per deciliter (g/dL)||Standard Deviation|Mean
2601537|NCT02151526|Secondary|Number of Participants With Vaso-Occlusive Crisis (VOC) and/or Acute Chest Syndrome (ACS) Events Post Drug Product Infusion in Sickle Cell Disease Participants|Number of VOCs, ACS, and vaso-occlusive events (VOEs; which included both VOC and ACS) through 24 months after drug product infusion.|From time of drug product infusion through Month 24|This outcome measure was evaluated in ITT population. This outcome measure was only planned to evaluate in SCD participants. Events of VOC and ACS were from same participant.|||Participants|||Count of Participants
2620699|NCT01953328|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
2601538|NCT02151526|Secondary|Percentage Change From Baseline in Annualized Number of Packed Red Blood Cell (pRBC) Transfusions|Percentage change from baseline in annualized number of pRBC transfusions from 6 months post-drug product infusion through last visit were reported.|Baseline, From 6 months post-drug product infusion through Month 24|This outcome measure was evaluated in the Transplant Population (TP).|||percentage change in pRBC transfusion||Full Range|Median
2601539|NCT02151526|Secondary|Percentage Change From Baseline in Annualized Packed Red Blood Cell (pRBC) Transfusion Volume|Percent change from baseline in the average annual transfusion volume from 6 months post-drug product infusion through last visit were reported.|Baseline, From 6 months post-drug product infusion through Month 24|This outcome measure was evaluated in the Transplant Population (TP).|||percent change in Annualized pRBC volume||Full Range|Median
2601540|NCT02151526|Secondary|Weighted Average Nadir Hemoglobin (Hb) in Participants With Transfusion-Dependent β-Thalassemia (TDT)|Weighted average Hb nadir was defined as an average area under the curve where the Hb closest but within 3 days prior to a transfusion was used as the Hb nadir. Hb values on the day of the transfusion were considered for nadir calculations.|From 6 months post-drug product infusion through Month 24|This outcome measure was evaluated only in Transplant Population (TP) with TDT.|||grams per deciliter (g/dL)||Full Range|Median
2601541|NCT02151526|Secondary|Time From LentiGlobin BB305 Drug Product Infusion to Achieving Transfusion Independence (TI) in Participants With Transfusion-Dependent β-Thalassemia (TDT)|TI was defined as a weighted average Hb > or =9 grams per deciliter (g/dL) without any pRBC transfusions for a continuous period of > or =12 months at any time during the study after drug product infusion, where calculation of time period of TI starts when participants achieve a Hb > or =9 g/dL with no transfusions in the preceding 60 days. To meet the initial TI criteria, the weighted Hb must be > or =9 g/dL at the end of the 12-month period, to remain in the TI state beyond the 12-month period, the treated participant needs to maintain a weighted Hb of > or =9 g/dL from that point forward, without receiving a pRBC transfusion. This outcome measure reports the time from infusion to achievement of TI.|From time of drug product infusion through Month 24|This outcome measure was evaluated only in Transplant Population (TP) with TDT. The number of participants analyzed signifies participants who were evaluable for this specific outcome measure.|||Month||Full Range|Median
2601542|NCT02151526|Secondary|Time From LentiGlobin BB305 Drug Product Infusion to Last Packed Red Blood Cells (pRBC) Transfusion Prior to Achieving Transfusion Independence (TI) in Participants With Transfusion-Dependent β-Thalassemia (TDT)|TI was defined as a weighted average Hb > or =9 grams per deciliter (g/dL) without any pRBC transfusions for a continuous period of > or =12 months at any time during the study after drug product infusion, where calculation of time period of TI starts when participants achieve a Hb > or =9 g/dL with no transfusions in the preceding 60 days. To meet the initial TI criteria, the weighted Hb must be > or =9 g/dL at the end of the 12-month period, to remain in the TI state beyond the 12-month period, the treated participant needs to maintain a weighted Hb of > or =9 g/dL from that point forward, without receiving a pRBC transfusion. This endpoint reports the time from infusion to the last pRBC transfusion prior to achieving TI.|From time of drug product infusion through Month 24|This outcome measure was evaluated only in Transplant Population (TP) with TDT. The number of participants analyzed signifies participants who were evaluable for this specific outcome measure.|||Days||Full Range|Median
2601543|NCT02151526|Secondary|Duration of Transfusion Independence (TI) in Participants With Transfusion-Dependent β-Thalassemia (TDT)|TI was defined as a weighted average Hb > or =9 grams per deciliter (g/dL) without any pRBC transfusions for a continuous period of > or =12 months at any time during the study after drug product infusion, where calculation of time period of TI starts when participants achieve a Hb > or =9 g/dL with no transfusions in the preceding 60 days. To meet the initial TI criteria, the weighted Hb must be > or =9 g/dL at the end of the 12-month period, to remain in the TI state beyond the 12-month period, the treated participant needs to maintain a weighted Hb of > or =9 g/dL from that point forward, without receiving a pRBC transfusion. This outcome measure reports the duration of TI and was evaluated in the TDT Transplant Population (TP) that reached TI.|From time of drug product infusion through Month 24|This outcome measure was evaluated only in Transplant Population (TP) with TDT. The number of participants analyzed signifies participants who were evaluable for this specific outcome measure.|||Month||Full Range|Median
2601544|NCT02151526|Secondary|Weighted Average Hemoglobin (Hb) During Period of Transfusion Independence (TI) in Participants With Transfusion-Dependent β-Thalassemia (TDT)|TI was defined as a weighted average hemoglobin (Hb) > or =9 grams per deciliter (g/dL) without any pRBC transfusions for a continuous period of > or =12 months at any time during the study after drug product infusion, where calculation of time period of TI starts when participants achieve a Hb > or =9 g/dL with no transfusions in the preceding 60 days.|From time of drug product infusion through Month 24|This outcome measure was evaluated only in Transplant Population (TP) with TDT. The number of participants analyzed signifies participants who were evaluable for this specific outcome measure.|||grams per deciliter (g/dL)||Full Range|Median
2601545|NCT02151526|Secondary|Percentage of Treated Participants With Transfusion-Dependent β-Thalassemia (TDT) Who Achieved Transfusion Independence (TI)|TI was defined as a weighted average hemoglobin (Hb) > or =9 grams per deciliter (g/dL) without any pRBC transfusions for a continuous period of > or =12 months at any time during the study after drug product infusion, where calculation of time period of TI starts when participants achieve a Hb > or =9 g/dL with no transfusions in the preceding 60 days.|From time of drug product infusion through Month 24|This outcome measure was evaluated only in Transplant Population (TP) with TDT.|||Percentage of participants|||Number
2601546|NCT02151526|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence associated with the use of a drug in participants, whether or not considered drug related. An AE may include a change in physical signs, symptoms, and/or clinically significant laboratory change occurring in any phase of a clinical study. This definition includes inter-current illnesses or injuries, and exacerbation of pre-existing conditions. An SAE was any AE, occurring at any dose and regardless of causality, that resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or was considered an important medical event that may jeopardize the participant and may require medical or surgical intervention to prevent an outcome listed previously. The number of participants with AEs and SAEs were evaluated.|From date of Informed Consent signing up to Month 24|This outcome measure was evaluated in the ITT population.|||Participants|||Count of Participants
2601547|NCT02151526|Primary|Number of Treated Participants With Greater Than (>) 30 Percent (%) Contribution of an Individual Clone As Per Integration Site Analysis (ISA)|Clonal dominance was defined as an ISA result greater than (>) 90% of the total insertion sites (IS) at any time and a vector copy number (VCN) > or =0.3, or an initial ISA result of > 30% of the total IS with a VCN > or =0.3 followed by a result > 30% and less than or equal to (< or =) 90% at first repeat and a result > 50% at second repeat.|From time of drug product infusion through Month 24|This outcome measure was evaluated in the Transplant Population (TP).|||Participants|||Count of Participants
2601548|NCT02151526|Primary|Percentage of Participants With Vector-Derived Replication-Competent Lentivirus (RCL)|Blood samples were analyzed for detection of RCL using RCL co-culture assay.|From time of drug product infusion through Month 24|This outcome measure was evaluated in the ITT population.|||Percentage of participants|||Number
2601549|NCT02151526|Primary|Number of Participants With Overall Survival (OS) Events|Overall survival was defined as time from date of LentiGlobin BB305 Drug Product infusion (Day 1) to date of death. Overall survival was censored at the date of last visit if the participant was still alive. Number of participants with OS events were reported.|From time of drug product infusion through Month 24|Intent to Treat (ITT) population consisted of all participants who initiated any study procedures, beginning with mobilization (by Granulocyte colony stimulating factor [G-CSF] with or without plerixafor), or bone marrow harvest.|||Participants|||Count of Participants
2601550|NCT02151526|Primary|Incidence of Transplant Related Mortality|This was the safety outcome measure related to mortality. Transplant related mortality was defined as any death occurring in the study post drug product infusion deemed related to the transplant by the investigator.|From screening through 365 days post-transplant|This outcome measure was evaluated in the Transplant Population (TP).|||Number of deaths reported|||Number
2601551|NCT02151526|Primary|Time to Successful Neutrophil and Platelet Engraftment|Neutrophil engraftment was defined as the first of ANC > or = 0.5 × 10^9/ liter (L) for 3 consecutive days (or 3 consecutive measurements done on separate days), after a post-transplant value < 0.5 × 10^9/L). Platelet engraftment was defined as the first of 3 consecutive platelet values > or =20 × 10^9/L for participants with TDT and values > or =50 × 10^9/L for participants with SCD obtained on different days with no platelet transfusions administered for 7 days immediately preceding and during the evaluation period. The day of engraftment is the first day of the 3 consecutive platelet measurements.|From time of drug product infusion through Month 24|This outcome measure was evaluated in the Transplant Population (TP).|||Days||Full Range|Median
2601552|NCT02151526|Primary|Number of Treated Participants With Successful Neutrophil and Platelet Engraftment|Neutrophil engraftment was defined as the first of absolute neutrophil count (ANC) > or = 0.5 × 10^9/ liter (L) for 3 consecutive days (or 3 consecutive measurements done on separate days), after a post-transplant value less than (<) 0.5 × 10^9/L. Platelet engraftment was defined as the first of 3 consecutive platelet values > or =20 × 10^9/L for participants with TDT and values > or =50 × 10^9/L for participants with SCD obtained on different days with no platelet transfusions administered for 7 days immediately preceding and during the evaluation period. The day of engraftment is the first day of the 3 consecutive platelet measurements.|From time of drug product infusion through Month 24|Transplant Population (TP) included all participants in the Intent to treat population who underwent LentiGlobin BB305 Drug Product infusion.|||Participants|||Count of Participants
2601553|NCT02151487|Secondary|Postoperative Analgesia|Post-operative Visual Analog Pain (VAS) scores on the scale of 10 (0=no pain and 10=worse imaginary pain).|within 15 minutes at postanesthesia care unit (PACU) arrival|Patients received supraclavicular nerve block with ropivacaine alone or ropivacaine with adjuvants. Postoperative pain was evaluated by using Visual Analog Pain Scores on the scale of 10 (0=no pain and 10-worse pain).|||score on a scale of 10||Inter-Quartile Range|Median
2601554|NCT02151487|Primary|Duration of the Sensorial Supraclavicular Block|Duration of sensorial block defined as the time interval between subject admitted to the Post-Anesthesia Care Unit and the time the first pain medication taken at home|within 24-hr after surgery|Participants received supraclavicular nerve block with ropivacaine alone and ropivacaine with adjuvants.|||hour||Standard Deviation|Mean
2601555|NCT02151461|Secondary|Change From Baseline to Day 28 in Fasting Plasma Insulin Concentration|Effect on fasting plasma insulin concentrations across fixed-dose leucine and metformin combination treatments or the standard metformin reference treatment was evaluated.|Baseline, Day 28|Mixed Model Inferential Statistical Analysis of Plasma Insulin AUC and Incremental AUC change from day 1-day 28 Evaluable Population (n=73). Some collected were not viable. So, the total samples collected were still the same but since they could not be included in the analysis the exact number analyzed is referenced.|||h*uIU/mL||Standard Deviation|Mean
2601556|NCT02151461|Secondary|Plasma Insulin Absolute and Incremental Meal Tolerance Test Area Under the Curve (AUC) 0-2hr|Change in meal tolerance test insulin area under the curve (0-2 hr) from Day 1 to Day 28 for fixed-dose leucine and metformin combination treatments.|Baseline,Day 28|Mixed Model Inferential Statistical Analysis of Plasma Insulin AUC and Incremental AUC change from day 1-day 28 Evaluable Population (n=73). Some samples collected were not viable. The total samples collected were still the same but since they couldn't included in the analysis, exact number analyzed is referenced.|||h*ulU/ml||Standard Deviation|Mean
2601557|NCT02151461|Secondary|Change In 7-Point Glucose Profiles|The meal induced glucose change in pre-meal and post-meal glucose were measured 7 times during the day. Subjects self-monitored blood glucose (preprandial and postprandial) concentrations at least 7 times, including before and 1 to 2 hours after breakfast, lunch, dinner, and snacks). For each study day, the pre-meal values from the 7 point test for each subject were averaged to generate a single pre-meal glucose value. Similarly, for each study day the post-meal values from the 7-point test for each subject were averaged to generate a single post-meal glucose value. The average change from baseline (i.e., [(Mean Pre/Post-meal value at Day 28 - Mean Pre/Post-meal value at Baseline) + (Mean Pre/Post-meal value at Day 21- Mean Pre/Post-meal value at Baseline) + (Mean Pre/Post-meal value at Day 7- Mean Pre/Post-meal value at Baseline)]/ 3) over multiple time points listed in Time Frame. The mean pre-meal and post-meal values for baseline, day7, day 21 and day28 were used for comparison.|Baseline, Day 7, Day 21, Day 28|Mixed Model Inferential Statistical Analysis of 7 point glucose change from day 1-day 28 Evaluable Population (n=73). Some of the samples collected were not viable and could not be included in the analysis. The total samples collected were still the same but since they could not be included in the analysis the exact number analyzed is referenced.|||mg/dL||Standard Deviation|Mean
2601558|NCT02151461|Secondary|Change in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR)|Effect on insulin sensitivity across fixed-dose leucine and metformin combination treatments or the standard metformin reference treatment.|Baseline, Day 28|Mixed Model Inferential Statistical Analysis of HOMA-IR. Some of the samples collected were not viable and could not be included in the analysis. So, the total samples collected were still the same but since they could not be included in the analysis the exact number analyzed is referenced.|||HOMA units||Standard Deviation|Mean
2601559|NCT02151461|Secondary|Change in Hemoglobin A1c (HbA1c)|Changes in HbA1c which is a marker of long-term glucose control was assessed.|Baseline, Day 28|Mixed Model Inferential Statistical Analysis of HbA1c change from day 1-day 28 Evaluable Population (n=73)|||percent||Standard Deviation|Mean
2601560|NCT02151461|Secondary|Change in Fasting Plasma Glucose|Change in fasting plasma glucose for the fixed dose leucine and metformin combination treatments A, B and C was evaluated.|Baseline, Day 28|Mixed Model Inferential Statistical Analysis of Fasting Plasma Glucose change from day 1-day 28 Evaluable Population (n=73)|||mg/dL||Standard Deviation|Mean
2601561|NCT02151461|Secondary|Change From Baseline to Day 28 in Incremental Plasma Glucose Area Under the Curve (AUC)|The baseline incremental (baseline-subtracted) glucose AUC0-3h was evaluated for treatment differences at baseline.|Baseline, Day 28|Mixed Model Inferential Statistical Analysis of Incremental Plasma Glucose AUC change from day 1-day 28 Evaluable Population (n=73)|||mg*hrs/dL||Standard Deviation|Mean
2601562|NCT02151461|Primary|Change From Baseline to Day 28 in Absolute Plasma Glucose Area Under the Curve (AUC) 0-3hr|The primary endpoint for NS 0100 01 was the absolute plasma glucose AUC (0-3 hr) change from Day 1 to Day 28.|0, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 2.5hrs and 3 hrs|Mixed Model Inferential Statistical Analysis of Plasma Glucose AUC change from day 1-day 28 Evaluable Population (n=73)|||mg*hrs/dL||Standard Deviation|Mean
2601563|NCT02151448|Secondary|Tumor Necrosis Factor (TFNα) Cytokine Levels|Tumor necrosis factor (TFNα) cytokine concentration levels measures in peripheral blood. Higher TFNα levels is associated with good prognosis.|Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)|Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment, and with ≥80% of samples available with measurable cytokine profiles via peripheral blood assay.|||pg/mL||Standard Deviation|Mean
2601564|NCT02151448|Secondary|Stromal Derived Factor 1 Alpha (SDF-1A/CXCL-12) Chemokine Levels|Levels of stromal derived factor 1 alpha (SDF-1A/CXCL-12) chemokine in peripheral blood. Higher levels of SDF-1A/CXCL-12 is associated with good prognosis.|Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)|Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment, and with ≥80% of samples available with measurable cytokine profiles via peripheral blood assay.|||pg/mL||Standard Deviation|Mean
2601565|NCT02151448|Secondary|Interleukin-8 (IL-8) Cytokine Levels|Interleukin-8 (IL-8) cytokine concentration levels measures in peripheral blood. Increased levels of IL-8 is associated with associated with advanced disease and poor prognosis.|Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)|Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment, and with ≥80% of samples available with measurable cytokine profiles via peripheral blood assay.|||pg/mL||Standard Deviation|Mean
2601566|NCT02151448|Secondary|Interleukin 6 (IL-6) Cytokine Levels|Interleukin 6 (IL-6) concentration levels measures in peripheral blood. Increased levels of IL-6 is associated with associated with advanced disease and poor prognosis.|Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)|Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment, and with ≥80% of samples available with measurable cytokine profiles via peripheral blood assay.|||pg/mL||Standard Deviation|Mean
2601567|NCT02151448|Secondary|Interleukin 10 (IL-10) Levels|Interleukin 10 (IL-10) (human cytokine synthesis inhibitory factor (CSIF)) concentration levels measures in peripheral blood. Increased levels of IL-10 is associated with advanced disease and poor prognosis.|Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)|Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment, and with ≥80% of samples available with measurable cytokine profiles via peripheral blood assay.|||pg/ml||Standard Deviation|Mean
2601568|NCT02151448|Secondary|CXCL11 (C-X-C Motif Chemokine 11) Levels|CXCL11 (C-X-C motif chemokine 11) protein concentration levels measures in peripheral blood. Increased levels can be predictive of good prognosis.|Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)|Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment, and with ≥80% of samples available with measurable cytokine profiles via peripheral blood assay.|||pg/mL||Standard Deviation|Mean
2601569|NCT02151448|Secondary|CXCL10 (Interferon Gamma-induced Protein 10) Levels|Chemokine CXCL10 (Interferon gamma-induced protein 10) concentration levels measures in peripheral blood as a biomarker of anti-tumor activity. Increased levels can be predictive of good prognosis.|Prior to vaccine administration (Week 1), prior to vaccine booster (Week 4) and after vaccine booster (Week 8)|Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment, and with ≥80% of samples available with measurable cytokine profiles via peripheral blood assay.|||pg/mL||Standard Deviation|Mean
2601570|NCT02151448|Secondary|Progression-free Survival (PFS)|The length of time during and after the treatment that patients remain alive with disease that does not progress. Per RECIST 1.1, Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|Up to 5 years|Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for completing surgery and response to treatment.|||months||95% Confidence Interval|Median
2601572|NCT02151448|Secondary|Time to Progression (TTP)|The length of time from the start of treatment until disease progression, per RECIST 1.1 considering only patients whose deaths were from cancer. Disease progression per RECIST 1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|Up to18 months|Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for for completing surgery and response to treatment.|||months||95% Confidence Interval|Median
2601573|NCT02151448|Primary|Adverse Events Possibly, Probably or Definitely Related to Study Treatment|Number of participants with adverse events (by Grade) that were possibly, probably or definitely related to the combined study immunotherapy regimen (αDC1 vaccines + CKM) per CTCAE v 4.0 (Common Terminology Criteria for Adverse Events).|Up to 24 weeks|Patients treated with at least 1 course of α DC1 vaccine + 1 cycle of chemokine modulatory regimen who were evaluable for for completing surgery.|||Participants|||Count of Participants
2601574|NCT02151448|Primary|Recommended Phase 2 Dose (RP2D) (Phase 1)|Number of patients treated at each of the three possible dose levels of Interferon α (5 MU/m^2, 10 MU/m^2 or 20 MU/m^2) during the Phase 1 portion of the study.|Up to 24 weeks|Only includes patients participating in the Phase 1 portion.|||Participants|||Count of Participants
2601575|NCT02151383|Secondary|Baseline and Change From Baseline in Mean Blood Lactate Levels (Central Venous Blood) for High Dose (10-30-100 ug/kg/Day)|The evaluations, as available, were done at baseline, prior to each dose escalation and at approximately 24 hours after the end of the infusion. Hemodynamic effects were also assessed for safety at additional time points during the study. Absolute values are presented at baseline; change from baseline values are presented at post-baseline time points|Day 1: hour 0 (Baseline) and 16, Day 2: hour 32 and 48, Day 3: 24 hours post infusion|participants with available data differed across time points|||mmol/L||Standard Deviation|Mean
2601576|NCT02151383|Secondary|Baseline and Change From Baseline in Mean Blood Lactate Levels (Arterial Blood) for High Dose (10-30-100 ug/kg/Day)|The evaluations, as available, were done at baseline, prior to each dose escalation and at approximately 24 hours after the end of the infusion. Hemodynamic effects were also assessed for safety at additional time points during the study. Absolute values are presented at baseline; change from baseline values are presented at post-baseline time points|Day 1: hour 0 (Baseline) and 16, Day 2: hour 32 and 48, Day 3: 24 hours post infusion|participants with available data differed across time points|||mmol/L||Standard Deviation|Mean
2601577|NCT02151383|Secondary|Baseline and Change From Baseline in Mean Blood Lactate Levels (Central Venous Blood) for Low Dose (3-10-30 ug/kg/Day)|The evaluations, as available, were done at baseline, prior to each dose escalation and at approximately 24 hours after the end of the infusion. Hemodynamic effects were also assessed for safety at additional time points during the study. Absolute values are presented at baseline; change from baseline values are presented at post-baseline time points|Day 1: hour 0 (Baseline) and 16, Day 2: hour 32 and 48, Day 3: 24 hours post infusion|participants with available data differed across time points|||mmol/L||Standard Deviation|Mean
2601578|NCT02151383|Secondary|Baseline and Change From Baseline in Mean Blood Lactate Levels (Arterial Blood) for Low Dose (3-10-30 ug/kg/Day)|The evaluations, as available, were done at baseline, prior to each dose escalation and at approximately 24 hours after the end of the infusion. Hemodynamic effects were also assessed for safety at additional time points during the study. Absolute values are presented at baseline; change from baseline values are presented at post-baseline time points|Day 1: hour 0 (Baseline) and 16, Day 2: hour 32 and 48, Day 3: 24 hours post infusion|participants with available data differed across time points|||mmol/L||Standard Deviation|Mean
2601579|NCT02151383|Secondary|Baseline and Change From Baseline in Mean Urine Output for High Dose (10-30-100 ug/kg/Day)|The evaluations, as available, were done at baseline, prior to each dose escalation and at approximately 24 hours after the end of the infusion. Hemodynamic effects were also assessed for safety at additional time points during the study. Absolute values are presented at baseline; change from baseline values are presented at post-baseline time points|Day 1: hour 0 (Baseline) and 16, Day 2: hour 32 and 48, Day 3: 24 hours post infusion|participants with available data differed across time points|||mL/kg/hour||Standard Deviation|Mean
2601580|NCT02151383|Secondary|Baseline and Change From Baseline in Mean Urine Output for Low Dose (3-10-30 ug/kg/Day)|The evaluations, as available, were done at baseline, prior to each dose escalation and at approximately 24 hours after the end of the infusion. Hemodynamic effects were also assessed for safety at additional time points during the study. Absolute values are presented at baseline; change from baseline values are presented at post-baseline time points|Day 1: hour 0 (Baseline) and 16, Day 2: hour 32 and 48, Day 3: 24 hours post infusion|participants with available data differed across time points|||mL/kg/hour||Standard Deviation|Mean
2601581|NCT02151383|Secondary|Baseline and Change From Baseline in Mean Central Venous Pressure and Arterial Oxygen Saturation for High Dose (10-30-100 ug/kg/Day)|"This analysis includes central venous and arterial oxygen saturation measurement, yielding a calculation of the arterio-venous oxygen extraction, where available at each time point. If no arterial access was available, then arterial oxygen saturation measurement data were obtained using a pulse oximeter.~The evaluations, as available, were done at baseline, prior to each dose escalation and at approximately 24 hours after the end of the infusion. Hemodynamic effects were also assessed for safety at additional time points during the study. Absolute values are presented at baseline; change from baseline values are presented at post-baseline time points"|Day 1: hour 0 (Baseline) and 16, Day 2: hour 32 and 48, Day 3: 24 hours post infusion|participants with available data differed across time points|||percentage of oxygen saturation||Standard Deviation|Mean
2601625|NCT02151110|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI4920|The area under the plasma concentration-time curve from time zero to infinity (AUC 0-inf) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.|Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first|As-treated Population|||microgram*day per milliliter (µg*d/mL)||Standard Deviation|Mean
2620700|NCT01953328|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
2601582|NCT02151383|Secondary|Baseline and Change From Baseline in Mean Central Venous Pressure and Arterial Oxygen Saturation for Low Dose (3-10-30 ug/kg/Day)|This analysis includes central venous and arterial oxygen saturation measurement, yielding a calculation of the arterio-venous oxygen extraction, where available at each time point. If no arterial access was available, then arterial oxygen saturation measurement data were obtained using a pulse oximeter. The evaluations, as available, were done at baseline, prior to each dose escalation and at approximately 24 hours after the end of the infusion. Hemodynamic effects were also assessed for safety at additional time points during the study. Absolute values are presented at baseline; change from baseline values are presented at post-baseline time points|Day 1: hour 0 (Baseline) and 16, Day 2: hour 32 and 48, Day 3: 24 hours post infusion||||percentage of oxygen saturation||Standard Deviation|Mean
2601583|NCT02151383|Secondary|Change From Baseline in Mean Central Venous Pressure for High Dose (10-30-100 ug/kg/Day)|The evaluations, as available, were done at baseline, prior to each dose escalation and at approximately 24 hours after the end of the infusion. Hemodynamic effects were also assessed for safety at additional time points during the study. Absolute values are presented at baseline; change from baseline values are presented at post-baseline time points|Day 1: hour 0 (Baseline) and 16, Day 2: hour 32 and 48, Day 3: 24 hours post infusion|participants with available data differed across time points|||mmHg||Standard Deviation|Mean
2601584|NCT02151383|Secondary|Change From Baseline in Mean Central Venous Pressure for Low Dose (3-10-30 ug/kg/Day)|The evaluations, as available, were done at baseline, prior to each dose escalation and at approximately 24 hours after the end of the infusion. Hemodynamic effects were also assessed for safety at additional time points during the study. Absolute values are presented at baseline; change from baseline values are presented at post-baseline time points|Day 1: hour 0 (Baseline) and 16, Day 2: hour 32 and 48, Day 3: 24 hours post infusion|participants with available data differed across time points|||mmHg||Standard Deviation|Mean
2601585|NCT02151383|Secondary|Change From Baseline in Mean Pulmonary Artery Pressure (PAP- Systolic and Diastolic) for High Dose (10-30-100 ug/kg/Day)|The evaluations, as available, were done at baseline, prior to each dose escalation and at approximately 24 hours after the end of the infusion. Hemodynamic effects were also assessed for safety at additional time points during the study. Absolute values are presented at baseline; change from baseline values are presented at post-baseline time points|Day 1: hour 0 and 16, Day 2: hour 32 and 48, Day 3: 24 hours post infusion|no data available for any time points||||||
2601586|NCT02151383|Secondary|Change From Baseline in Mean Pulmonary Artery Pressure (PAP- Systolic and Diastolic) for Low Dose (3-10-30 ug/kg/Day)|The evaluations, as available, were done at baseline, prior to each dose escalation and at approximately 24 hours after the end of the infusion. Hemodynamic effects were also assessed for safety at additional time points during the study. Absolute values are presented at baseline; change from baseline values are presented at post-baseline time points|Day 1: hour 0 (Baseline) and 16, Day 2: hour 32 and 48, Day3: 24 hours post infusion|participants with available data differed across time points|||mmHg||Standard Deviation|Mean
2601587|NCT02151383|Secondary|Change From Baseline in Mean Left Arterial Pressure for High Dose (10 -30-100 ug/kg/Day)|The evaluations, as available, were done at baseline, prior to each dose escalation and at approximately 24 hours after the end of the infusion. Hemodynamic effects were also assessed for safety at additional time points during the study.|baseline, prior to each dose escalation, and at 24 hr. post end of infusion|No data available||||||
2601588|NCT02151383|Secondary|Change From Baseline in Mean Left Arterial Pressure for Low Dose (3-10-30 ug/kg/Day)|The evaluations, as available, were done at baseline, prior to each dose escalation and at approximately 24 hours after the end of the infusion. Hemodynamic effects were also assessed for safety at additional time points during the study.|baseline, prior to each dose escalation, and at 24 hr. post end of infusion|No data available||||||
2601589|NCT02151383|Primary|Pharmacokinetic Concentration for High Dose (10-30-100 ug/kg/Day)|Pharmacokinetic (PK) concentration was presented as the surrogate for PK parameters, the original primary endpoint, due to the unavailability of the PK parameters Css and CL. Serelaxin concentration was determined in serum by a validated Enzyme Linked ImmunoSorbent Assay (ELISA) based upon the commercially available kit from R&D Systems (Catalogue No. DRL200). The ELISA method used a monoclonal antibody specific for human H2 relaxin as the capture reagent and an enzyme-linked polyclonal antibody specific for human.|at 0, 2, 16, 22, 32, 40, 48 hr. during the infusion, at 0.5, 4, 8 hours post infusion or study drug discontinuation, and on day 28|No data available for Cohort 2 and 3|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2601590|NCT02151383|Primary|Pharmacokinetic Concentration for Low Dose 3-10-30 ug/kg/Day|Pharmacokinetic (PK) concentration was presented as the surrogate for PK parameters, the original primary endpoint, due to the unavailability of the PK parameters Css and CL. Serelaxin concentration was determined in serum by a validated Enzyme Linked ImmunoSorbent Assay (ELISA) based upon the commercially available kit from R&D Systems (Catalogue No. DRL200). The ELISA method used a monoclonal antibody specific for human H2 relaxin as the capture reagent and an enzyme-linked polyclonal antibody specific for human.|at 0, 2, 16, 22, 32, 40, 48 hr. during the infusion, at 0.5, 4, 8 hours post infusion or study drug discontinuation, and on day 28|participants with available data differed across time points|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2601591|NCT02151383|Primary|Number of Patients With Treatment Emergent Adverse Events, Serious Adverse Events and Death|Number of patients with treatment emergent adverse events (including confirmed systolic blood pressure decreases and worsening heart failure), serious adverse events and death were reported.|through 28 days + 30 days SAE follow up after completion or discontinuation from the study|All appropriately consented enrolled subjects who were exposed to study drug regardless of the exposure and have at least one post-baseline safety assessment.|||Patients|||Number
2601592|NCT02151331|Secondary|Reduced Mood Disorder Symptoms||Change from Baseline in Mood Disorder Symptoms at 24-months|No analysis was completed because the funder requested terminating the study due to low enrollment. No data was collected because the study was halted prematurely.||||||
2601593|NCT02151331|Secondary|Health-related Quality of Life - Mental Health Component Score|Health-related Quality of Life - Mental Health Component Score of the short form (SF)-12 survey|Change from Baseline in Quality of Life at 24-months|No analysis was completed because the funder requested terminating the study due to low enrollment. No data was collected because the study was halted prematurely.||||||
2601596|NCT02151266|Primary|Change in Reaction Time|"Scores are automatically calculated via the scoring software embedded within the CalCap and are standardized based on age and education level norms. Normative data are stratified by both age (20-34, 35-44, 45+) and education (< 16 years, 16 years, > 16 years). Lower scores reflect slower reaction time and higher scores reflect faster reaction time. Scores are automatically converted to age/education based standard scores and are reported as a T-score.~T-scores (as Z-scores) are used when neurocognitive test scores use different measurement scales, e.g., time to completion and number correct. This allows to report performance in a straightforward manner, with low and high scores reflecting poor and good performance consistently across different types of tests, and to provide interpretation of a person's performance in comparison to a group."|Baseline, 3 months, 6 months||||t scores||Standard Deviation|Mean
2601597|NCT02151266|Primary|Change in Working Memory Score|Digit Span Forward (0-16), Digit Span Backwards (0-16), Digit Span Sequencing (0-16) and Letter Number Sequencing (0-48) sections from the Wechsler Adult Intelligence Scale - Fourth Edition are used to assess Working Memory. The range of possible scores for each section are in parentheses. The Digit Span subtest require the repetition of verbally presented series of numbers that increase in length; trials include the repeating of numbers in forward, backward, and numerical order. The Letter-Number sequencing test requires the repeating strings of letters and numbers in numerical and then in alphabetical order. Color Trails Test (CTT) Part 2, participants rapidly connect numbered circles in sequence while alternating between pink and yellow circles. Higher scores reflect better outcome. Scores reflect number correct and are averaged for total correct Working Memory score; are then converted to Z-score.|Baseline, 3 months, 6 months||||z scores||Standard Deviation|Mean
2601598|NCT02151266|Primary|Change in Processing Speed/Attention Score|"RBANS coding (0-89) Color Trails 1 (timed test, 1-5 minutes) measures attention. The length of time to complete each part is recorded; lower raw scores reflect better processing speed and attention. Lower raw scores reflect better processing speed and attention. Scores are averaged for a total score, then converted to Z scores.~Z-scores are used when neurocognitive test scores use different measurement scales, e.g., time to completion and number correct. This allows to report performance in a straightforward manner, with low and high scores reflecting poor and good performance consistently across different types of tests, and to provide interpretation of a person's performance in comparison to a group. For interpretive purposes, a z-score has a mean of 0 and a standard deviation of 1. This means that an individual who has a z-score of 1.5 is performing one and a half standard deviations above the group to which he/she is compared."|Baseline, 3 months, 6 months||||z scores||Standard Deviation|Mean
2601599|NCT02151266|Primary|Visual Memory Score Change|"Visual memory will be assessed using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). RBANS figure recall requires the participant to remember a recent figure and redraw it from memory. The range of possible scores is 0-20. Scores are averaged, and then converted to z score.~Z-scores are used when neurocognitive test scores use different measurement scales, e.g., time to completion and number correct. This allows to report performance in a straightforward manner, with low and high scores reflecting poor and good performance consistently across different types of tests, and to provide interpretation of a person's performance in comparison to a group. For interpretive purposes, a z-score has a mean of 0 and a standard deviation of 1. This means that an individual who has a z-score of 1.5 is performing one and a half standard deviations above the group to which he/she is compared."|Baseline, 3 months, 6 months||||z scores||Standard Deviation|Mean
2601600|NCT02151266|Other Pre-specified|Peak V02|To evaluate change in cardio-respiratory fitness Peak V02 was assessed at baseline and 3 months using a motorized treadmill test across 3 arms of the study|Baseline and 3 months||||mL/kg/min||Standard Deviation|Mean
2601601|NCT02151266|Secondary|Functional Capacity|Functional capacity will be assessed by six-minute walk across all 3 arms of the study.|Baseline, 3 months, 6 months||||meters||Standard Deviation|Mean
2601602|NCT02151266|Primary|Verbal Memory Score Change|"List Learning (0-40), List Recall (0-10), and List Recognition (0-20) sections from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) are used to assess Verbal memory.The range of scores for each section are in parentheses. Higher scores reflect better verbal memory. Scores are averaged for a total Verbal memory score, then converted to Z-score.~Z-scores are used when neurocognitive test scores use different measurement scales, e.g., time to completion and number correct. This allows to report performance in a straightforward manner, with low and high scores reflecting poor and good performance consistently across different types of tests, and to provide interpretation of a person's performance in comparison to a group. For interpretive purposes, a z-score has a mean of 0 and a standard deviation of 1. This means that an individual who has a z-score of 1.5 is performing one and a half standard deviations above the group to which he/she is compared."|Baseline, 3 months, 6 months||||score on a scale||Standard Deviation|Mean
2601603|NCT02151253|Secondary|Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep)|Nocturic Events is defined as an episode of urination preceded and followed by sleep. Measurements are for the preceding week|week 4 of each phase.||||Nocturic Events||Standard Deviation|Mean
2601604|NCT02151253|Secondary|Mean Number of Minutes Napped Per Day Based on Sleep Diary|measurements are for the preceding week|week 4 of each phase.||||minutes napped per day||Standard Deviation|Mean
2601605|NCT02151253|Secondary|Mean Number of Naps/Day|measurements are for the preceding week|week 4 of each phase.||||naps per day||Standard Deviation|Mean
2601606|NCT02151253|Secondary|Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)|"Scale consists of a 7 point likert rating scale where the anchors were 1= normal; 2= borderline sleepiness; 3= mild sleepiness; 4= moderate sleepiness; 5= marked sleepiness; 6= severe sleepiness; and 7= among the most extremely sleepy individuals"|week 4, of each phase||||units on a scale||Standard Deviation|Mean
2601607|NCT02151253|Primary|Change From Baseline in Epworth Sleepiness Scale [ESS]|Epworth sleepiness scale (ESS) is measure of subjective sleepiness. Tendency to fall asleep in 8 situations. Total varies from zero to 24. A ESS of 10 or less is considered normal. Change is calculated as value at baseline minus value at week 4.|Baseline, Week 4 of each phase||||units on a scale||Standard Deviation|Mean
2601648|NCT02150837|Secondary|Fat Mass|Fat mass expressed as an absolute change from baseline.|24 weeks|Not all subjects remaining at 24 weeks had body composition testing performed.|||Pounds||Standard Deviation|Mean
2601608|NCT02151149|Secondary|Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to RECIST 1.1 Criteria|Overall response rate (ORR) was defined as the percentage of participants who had radiologic CR or PR compared to baseline (radiographic evaluation on the day of or within 28 days prior to randomization) according to RECIST Version 1.1 criteria as determined by the investigator, which was confirmed by repeated radiologic assessment performed no less than 28 days after the criteria for response were first met and occurred between Day 1 of treatment and the start of subsequent anticancer therapy, death or study discontinuation. A complete response and partial response per RECIST V 1.0 criteria was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of diameters of target lesions from baseline.|From the first dose of IP to the date of documented first response; up to the data cut-off date of 14 July 2017; maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively.|Intent to Treat Population included all randomized participants regardless of whether the participant received any study drug or had any efficacy assessments performed.|||Percentage of participants||95% Confidence Interval|Number
2601609|NCT02151149|Secondary|Kaplan Meier Estimate of Overall Survival (OS)|Overall survival was defined as the time in months between day 1 of treatment and death from any cause). Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.|From first dose of IP to the date of death due to any cause; up to a later clinical cut-off date of 14 July 2017; for Arms A and B participants were followed for OS for 31 months and 33 months respectively|Intent to Treat Population included all randomized participants regardless of whether the participant received any study drug or had any efficacy assessments performed.|||months||95% Confidence Interval|Median
2601610|NCT02151149|Secondary|Kaplan Meier Estimate of Progression-Free Survival (PFS)|Progression-free survival was defined as the time in months from day 1 of treatment to the date of disease progression based on the investigator's assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by radiological assessment) or death (any cause) on or prior to the clinical cut-off date, which ever occurred earlier. RECIST V1.1 criteria includes: - Complete Response (CR) is the disappearance of all target lesions; - Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions from baseline; - Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease (PD); - Progressive Disease is at least a 20% increase in the sum of diameters of target lesions from nadir|From first dose of IP to the date of disease progression; up to a later clinical cut-off date of 14 July 2017; for Arms A and B participants were followed for PFS for 31 months and 20 months respectively|Intent to Treat Population all randomized participants regardless of whether the participant received any study drug or had any efficacy assessments performed.|||months||95% Confidence Interval|Median
2601611|NCT02151149|Secondary|Percentage of Participants With a Dose Delay During the Entire Study|A dose delay occurred when the dose assigned at a visit was held compared to the previous visit. Dose delays were typically caused by clinically significant laboratory abnormalities and/or TEAEs or toxicities.|From the first dose of study treatment to discontinuation date of study treatment; up to date cut off date of 16 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively|The safety population consisted of all participants who received at least 1 dose of investigational product.|||Percentage of Participants|||Number
2601612|NCT02151149|Secondary|Percentage of Participants With Dose Reductions During the Entire Study|A dose reduction occurred when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions were typically caused by clinically significant laboratory abnormalities and/or TEAEs or toxicities.|From the first dose of study treatment to discontinuation date of study treatment; up to date cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively|The treated population consisted of all participants who received at least 1 dose of investigational product.|||Percentage of Participants|||Number
2601613|NCT02151149|Secondary|Dose Intensity Per Week of Carboplatin During the Entire Study|"Dose intensity for carboplatin was the cumulative dose divided by the dosing period in weeks."|From day 1 of study treatment to the end date of study treatment; up to data cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively|Treated Population included all randomized participants who received any study drug.|||mg*min/mL/week||Standard Deviation|Mean
2601614|NCT02151149|Secondary|Dose Intensity Per Week of Nab-Paclitaxel During the Entire Study|Dose intensity was the cumulative dose divided by the dosing period in weeks.|From day 1 of study treatment to the end date of study treatment; up to data cut off date of 20 November 2016; the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively|Treated Population included all randomized participants who received any study drug.|||mg/m^2/week||Standard Deviation|Mean
2601615|NCT02151149|Secondary|Percentage of Participants With at Least 1 Treatment Emergent Adverse Event With Action Taken as Study Drug Withdrawn|The percentage of participants with at least 1 TEAE with action taken as studydrug withdrawn during the treatment period of the trial was assessed throughout the conduct of the study. Study drug withdrawn (treatment permanently discontinued) was attributed to the part in which the onset of the adverse event took place.|From the date of the first dose of IP until 28 days after the last dose of IP; up to a later data cut-off date of 14 July 2017 the maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively|Safety Population included all participants who were randomized and received at least 1 dose of study drug.|||Percentage of Participants|||Number
2601626|NCT02151110|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI4920|The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.|Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first|As-treated Population|||microgram*day per milliliter (µg*d/mL)||Standard Deviation|Mean
2601616|NCT02151149|Secondary|Number of Participants With Treatment Emergent Adverse Events During the Treatment Period|"Treatment-emergent adverse events (TEAEs) were defined as any AE or serious adverse event (SAE) that occurred or worsened on or after the day of the first dose of the IP through 28 days after the last dose of IP. Any SAE with an onset date more than 28 day after the last dose of IP that was assessed by the investigator as related to IP was considered a TEAE. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and based on the scale:~Grade 1 = Mild - transient or mild discomfort; Grade 2 = Moderate - mild to moderate limitation in activity, assistance may be needed; minimal medical intervention required; Grade 3 = Severe - marked limitation in activity, assistance usually required; medical intervention required, hospitalization is possible; Grade 4 = Life threatening - extreme limitation in activity, assistance required; medical intervention, hospitalization or hospice care probable; Grade 5 = death."|From the date of the first dose of IP until 28 days after the last dose of IP; up to a later data cut-off date of 14 July 2017; maximum treatment duration for Arms A and B was 16.6 months and 20.1 months respectively.|Safety population included all participants who were randomized and received at least 1 dose of the study drug.|||Participants|||Count of Participants
2601617|NCT02151149|Primary|Percentage of Participants With Either Peripheral Neuropathy ≥ Grade 2 or Myelosuppression Adverse Events (AEs) ≥ Grade 3 Based on Local Laboratory Values|Peripheral neuropathy (sensory or motor) assessment was done at screening, on Days 1, 8, 15 of every treatment cycle, at the End-of-Treatment visit and at the 28-day Follow-up Visit. Changes in neuropathy grade from baseline was reported as an AE as assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Myelosuppression in participants receiving chemotherapy may have manifested as neutropenia, thrombocytopenia, or anemia. Grade 3 neutropenia including an absolute neutropenia count (ANC) of 500 to 1,000 cells/mm^3; anemia hemoglobain levels (Hgb) <8.0 - 6.5 g/dL; <4.9 - 4.0 mmol/L; <80 - 65 g/L; transfusion indicated; and thrombocytopenia with platelet levels <100,000 cells/mm^3.|From the date of the first dose of investigational product (IP) until 28 days after the last dose of IP; up to data cut-off date of 20 November 2016; The median treatment duration for Arms A and B were 3.04 months and 5.17 months respectively.|Treated Population included all participants who were randomized and received at least 1 dose of the study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2601618|NCT02151110|Secondary|T-cell Dependent Antibody Response (TDAR) Measured by Anti-keyhole Limpet Hemocyanin Immunoglobulin G (Anti-KLH IgG) Concentration|The T-cell dependent antibody response (TDAR) assay measures the immune response (ie, antibody production) to an introduced antigen, keyhole limpet hemocyanin (KLH). The KLH is a potent immunostimulating protein with an extensive history of safe and effective use in vaccine development and immunological research. TDAR was evaluated by measuring anti-KLH IgG titers at a time point consistent with the expected timing for antibody responses following immunization. The primary time point for the analysis of the TDAR to KLH was Day 43. The data was presented for geometric mean ratio (MEDI4920/placebo) estimated from the dose response model.|Day 43|As-treated Population.|||nanogram per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
2601619|NCT02151110|Secondary|Percentage of Participants Positive for Anti-drug Antibodies (ADA)|Plasma samples were collected for assessment of anti-drug antibodies (ADA) against MEDI4920. The incidence of positive serum antibodies to MEDI4920 are presented.|Baseline (pre-infusion on Day 1) and post-baseline Days 15, 29, 57, and 113 or early discontinuation visit, whichever occurred first|As-treated Population.|||Percentage of participants|||Number
2601620|NCT02151110|Secondary|Volume of Distribution Based on Terminal Phase (Vz) of MEDI4920|The volume of distribution based on terminal phase (Vz) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.|Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first|As-treated Population|||milliliter (mL)||Standard Deviation|Mean
2601621|NCT02151110|Secondary|Volume of Distribution at Steady-state (Vss) of MEDI4920|The volume of distribution at steady-state (Vss) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.|Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first|As-treated Population|||milliliter (mL)||Standard Deviation|Mean
2601622|NCT02151110|Secondary|Systemic Clearance (CL) of MEDI4920|The systemic clearance (CL) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.|Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first|As-treated Population|||milliliter per day (mL/day)||Standard Deviation|Mean
2601623|NCT02151110|Secondary|Terminal Elimination Half Life (t1/2) of MEDI4920|The terminal elimination half-life (t1/2) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.|Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first|As-treated Population|||Day(s)||Standard Deviation|Mean
2601624|NCT02151110|Secondary|Dose-normalized AUC0-inf (AUC0-infinity/D) of MEDI4920|The AUC (0-infinity)/D is the area under concentration-time curve extrapolated to infinity postdose normalized by MEDI4920 dose. The AUC (0-infinity)/D was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.|Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first|As-treated Population|||µg*d/mL/mg||Standard Deviation|Mean
2601627|NCT02151110|Secondary|Maximum Observed Plasma Concentration (Cmax) of MEDI4920|The maximum observed plasma concentration (Cmax) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.|Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first|As-treated Population|||microgram per milliliter (µg/mL)||Standard Deviation|Mean
2601628|NCT02151110|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly or birth defect in the offspring of a participant who received the study drug. A TEAE is defined as the event with onset after the start of infusion (Day 1) to Day 113 or early discontinuation visit inclusive. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0.|The start of study drug administration (Day 1) to the follow-up period (Day 113) or early discontinuation visit|As-treated Population: All participants who received any study drug were included in this population|||Participants|||Count of Participants
2601629|NCT02151058|Secondary|Lobene Stain Index Intensity Scores at Day 15|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.|15 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2601630|NCT02151058|Secondary|Lobene Stain Index Intensity Scores at Day 8|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.|8 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2601631|NCT02151058|Secondary|Lobene Stain Index Intensity Scores at Day 4|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = light stain, 2 = moderate stain, and 3 = heavy stain.|4 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2601632|NCT02151058|Secondary|Lobene Stain Index Area Scores at Day 15|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region.|15 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2601633|NCT02151058|Secondary|Lobene Stain Index Area Scores at Day 8|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region.|8 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2601634|NCT02151058|Secondary|Lobene Stain Index Area Scores at Day 4|Tooth stain surface was assessed by using scores on the Lobene Stain Index scored 0 - 3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region, and 3 = covering > 2/3 of the region.|4 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2601635|NCT02151058|Secondary|Lobene Stain Index Composite Score at Day 8|"Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.~The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth)."|8 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2601636|NCT02151058|Secondary|Lobene Stain Index Composite Score at Day 4|"Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.~The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth)."|4 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2601637|NCT02151058|Primary|Lobene Stain Index Composite Score at Day 15|"Tooth stain surface and stain intensity were assessed by using scores on the Lobene Stain Index (two part visual scale), scored 0 - 3. Where 0 = no stain, 1 = light stain, 2 = moderate stain and 3 = heavy stain. The second part of the scale examined the surface of the tooth on a scale of 0-3, where 0= no stain, 1 = covering up to 1/3 of the region, 2 = covering > 1/3 to 2/3 of the region and 3 = covering > 2/3 of the region.~The mean composite score (0-9) was determined by multiplying the individual tooth stain surface and stain intensity scores and summing then dividing by the number of regions scored for the subject (or tooth)."|15 Days|Analysis was based on the Full Analysis Set, which included all randomized subjects who used study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2601638|NCT02150954|Secondary|Neonatal Outcome: Late Fetal Heart Rate Decelerations|Late fetal heart rate decelerations were defined as a gradual decrease in the fetal heart rate associated with uterine contraction with the nadir of the deceleration occurring after the peak of the contraction.|during admission for delivery, up to approximately 4 days||||neonates|||Number
2601639|NCT02150954|Secondary|Neonatal Outcome: Placental Abruption|number of participants with placental abruption|during admission for delivery, up to approximately 4 days||||participants|||Number
2601649|NCT02150837|Secondary|Body Weight|Change in body weight from baseline to final weight loss visit reported as absolute change. (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.)|Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)||||Pounds||Standard Deviation|Mean
2601650|NCT02150837|Secondary|Body Weight|Change in body weight from baseline reported as absolute change.|20 weeks||||Pounds||Standard Deviation|Mean
2601651|NCT02150837|Secondary|Body Weight|Change in body weight from baseline reported as absolute change.|16 weeks||||Pounds||Standard Deviation|Mean
2601652|NCT02150837|Secondary|Body Weight|Change in body weight from baseline reported as absolute change.|8 weeks||||Pound||Standard Deviation|Mean
2601653|NCT02150837|Secondary|Body Weight|Change in body weight from baseline reported absolute change from baseline.|4 weeks||||Pounds||Standard Deviation|Mean
2601654|NCT02150837|Secondary|Body Weight|Change in body weight from baseline reported as absolute change from baseline.|2 weeks||||Pounds||Standard Deviation|Mean
2601655|NCT02150837|Secondary|Body Weight|Change in body weight from baseline reported as absolute change.|1 week||||Pounds||Standard Deviation|Mean
2601656|NCT02150837|Secondary|Adherence|Adherence will be assessed through documented use of meal replacements at each visit from baseline (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).|Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)||||Percent compliance meal replacements||Standard Deviation|Mean
2601657|NCT02150837|Secondary|Adherence|Adherence will be assessed through documented use of meal replacements at each visit.|24 weeks||||Percent compliance meal replacements||Standard Deviation|Mean
2601658|NCT02150837|Secondary|Adherence|Adherence will be assessed through documented use of meal replacements at each visit.|20 weeks||||Percent compliance meal replacements||Standard Deviation|Mean
2601659|NCT02150837|Secondary|Adherence|Adherence will be assessed through documented use of meal replacements at each visit.|16 weeks||||Percent compliance meal replacements||Standard Deviation|Mean
2601660|NCT02150837|Secondary|Adherence|Adherence will be assessed through documented use of meal replacements at each visit.|8 weeks||||Percent compliance meal replacements||Standard Deviation|Mean
2601661|NCT02150837|Secondary|Adherence|Adherence will be assessed through documented use of meal replacements at each visit.|4 weeks||||Percent compliance meal replacements||Standard Deviation|Mean
2601662|NCT02150837|Secondary|Pulse|Pulse expressed as an absolute change from baseline to final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).|Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)||||Beats per minute||Standard Deviation|Mean
2601663|NCT02150837|Secondary|Pulse|Pulse expressed as an absolute change from baseline.|24 weeks||||Beats per minute||Standard Deviation|Mean
2601664|NCT02150837|Secondary|Pulse|Pulse expressed as an absolute change from baseline.|20 weeks||||Beats per minute||Standard Deviation|Mean
2601665|NCT02150837|Secondary|Pulse|Pulse expressed as an absolute change from baseline.|16 weeks||||Beats per minute||Standard Deviation|Mean
2601666|NCT02150837|Secondary|Pulse|Pulse expressed as an absolute change from baseline.|8 weeks||||Beats per minute||Standard Deviation|Mean
2601667|NCT02150837|Secondary|Pulse|Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.|4 weeks||||Beats per minute||Standard Deviation|Mean
2601668|NCT02150837|Secondary|Pulse|Pulse expressed as an absolute change from baseline.|2 weeks||||mmHg||Standard Deviation|Mean
2601669|NCT02150837|Secondary|Pulse|Pulse expressed as an absolute change from baseline.|1 weeks||||Beats per minute||Standard Deviation|Mean
2601670|NCT02150837|Secondary|Blood Pressure|Blood pressure (systolic and diastolic) expressed as an absolute change from baseline to final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).|Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)|Not all subjects had measurement performed at their final visit.|||mmHg||Standard Deviation|Mean
2601671|NCT02150837|Secondary|Blood Pressure|Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.|24 weeks|Not all subjects were remaining at 24 weeks and not all had measurement performed.|||mmHg||Standard Deviation|Mean
2601672|NCT02150837|Secondary|Blood Pressure|Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.|20 weeks|Not all subjects were remaining at 20 weeks and not all had measurement performed.|||mmHg||Standard Deviation|Mean
2601673|NCT02150837|Secondary|Blood Pressure|Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.|16 weeks|Not all subjects were remaining at 16 weeks and not all had measurement performed.|||mmHg||Standard Deviation|Mean
2601674|NCT02150837|Secondary|Blood Pressure|Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.|8 weeks|Not all subjects were remaining at 8 weeks and not all had measurement performed.|||mmHg||Standard Deviation|Mean
2601675|NCT02150837|Secondary|Blood Pressure|Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.|4 weeks|Not all subjects were remaining at 4 weeks and not all had measurement performed.|||mmHg||Standard Deviation|Mean
2601676|NCT02150837|Secondary|Blood Pressure|Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.|2 weeks|Not all subjects were remaining at 2 weeks and not all had measurement performed.|||mmHg||Standard Deviation|Mean
2601677|NCT02150837|Secondary|Blood Pressure|Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.|1 weeks||||mmHg||Standard Deviation|Mean
2601678|NCT02150837|Secondary|Hip Circumference|Hip circumference expressed as an absolute change from baseline.|24 weeks||||Inches||Standard Deviation|Mean
2601679|NCT02150837|Secondary|Hip Circumference|Hip circumference expressed as an absolute change from baseline.|20 weeks||||Inches||Standard Deviation|Mean
2601680|NCT02150837|Secondary|Hip Circumference|Hip circumference expressed as an absolute change from baseline.|16 weeks||||Inches||Standard Deviation|Mean
2601702|NCT02150837|Secondary|Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight|The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans) at their final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).|Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)||||Percent of subjects|||Number
2601703|NCT02150837|Secondary|Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight|The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).|24 weeks||||Percent of subjects|||Number
2601704|NCT02150837|Secondary|Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight|The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).|20 weeks||||Percent of subjects|||Number
2601705|NCT02150837|Secondary|Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight|The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).|16 weeks||||Percent of subjects|||Number
2601706|NCT02150837|Secondary|Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight|The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).|8 weeks||||Percent of subjects|||Number
2601707|NCT02150837|Secondary|Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight|The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).|4 weeks||||Percent of subjects|||Number
2601708|NCT02150837|Secondary|Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight|The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).|2 weeks||||Percent of subjects|||Number
2601709|NCT02150837|Secondary|Proportion of Subjects Who Lose at Least 10% of Baseline Body Weight|The categorical endpoint of the proportion of subjects who lose at least 10% of baseline body weight while on each program (5 & 2 & 2 and 4 & 2 & 1 Plans).|1 weeks||||Percent of subjects|||Number
2601710|NCT02150837|Secondary|Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight|The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans) at their final weight loss visit (The mean length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).|Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)||||Percent of subjects|||Number
2601711|NCT02150837|Secondary|Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight|The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).|24 weeks||||Percent of subjects|||Number
2601712|NCT02150837|Secondary|Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight|The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).|20 weeks||||Percent of subjects|||Number
2601713|NCT02150837|Secondary|Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight|The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).|16 weeks||||Percent of subjects|||Number
2601714|NCT02150837|Secondary|Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight|The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).|8 weeks||||Percent of subjects|||Number
2601715|NCT02150837|Secondary|Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight|The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).|4 weeks||||Percent of subjects|||Number
2601716|NCT02150837|Secondary|Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight|The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).|2 weeks||||Percent of subjects|||Number
2601717|NCT02150837|Secondary|Proportion of Subjects Who Lose at Least 5% of Baseline Body Weight|The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).|1 weeks||||Percent of subjects|||Number
2601718|NCT02150837|Secondary|Adherence|Adherence will be assessed through attendance at weekly visits and documented use of meal replacements at each visit. (Meal replacement adherence=average number of self-reported daily meal replacements through 12 weeks/nuber of prescribed meal replacements; Attendance adherence=number of visits/number of weeks on plan|12 weeks||||Percent Compliant||Standard Deviation|Mean
2601719|NCT02150837|Secondary|Resting Metabolic Rate|Resting metabolic rate expressed as an absolute change from baseline to final weight loss visit (The average length of time from baseline to the final weight loss visit was 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan.).|Baseline to final weight loss visit (Average of 18 weeks for the 5 & 2 & 2 Plan and 17 weeks for the 4 & 2 & 1 Plan)|Number of participants with paired data at baseline and final weight loss visit was too small for meaningful analysis.|||calories||Standard Deviation|Mean
2601720|NCT02150837|Secondary|Blood Pressure Categorical|Blood pressure expressed as a categorical variable (normotensive, pre-hypertensive and hypertensive based on National Institute of Health Guidelines) with the percent of participants that improved (e.g. from hypertensive to pre-hypertensive or normal) their blood pressure category from baseline to 12 weeks.|12 weeks|Not all subjects were remaining at 12 weeks and not all had measurement performed.|||Percent of participants|||Number
2601721|NCT02150837|Secondary|Pulse|Pulse expressed as an absolute change from baseline.|12 weeks|Not all subjects were remaining at 12 weeks and not all had measurement performed.|||Beats per minute||Standard Deviation|Mean
2601722|NCT02150837|Secondary|Blood Pressure|Blood pressure (systolic and diastolic) expressed as an absolute change from baseline.|12 weeks|Not all subjects were remaining at 12 weeks and not all had measurement performed.|||mmHg||Standard Deviation|Mean
2601729|NCT02150837|Secondary|Percentage of Subjects Who Lose at Least 5% of Baseline Body Weight|The categorical endpoint of the proportion of subjects who lose at least 5% of baseline body weight while on each plan (5 & 2 & 2 and 4 & 2 & 1 Plans).|12 weeks||||percentage of subjects|||Number
2601730|NCT02150837|Primary|Body Weight|The primary endpoint in this study is weight and the primary outcome is change from baseline body weight at 12 weeks for each plan (5 & 2 & 2 and 4 & 2 & 1 Plans). Change from baseline will also be examined at other predetermined time points (e.g., 1, 2, 4, 8, 16, 20 and 24 weeks, and final weight loss visit - the mean length of time from baseline to the final weight loss visit was 18.06 weeks for the 5 & 2 & 2 Plan and 17.35 weeks for the 4 & 2 & 1 Plan.).|12 weeks||||Pounds||Standard Deviation|Mean
2601731|NCT02150759|Secondary|Quality of Patient Positioning|We estimate quality of patient positioning (0=not satisfactory, 1=satisfactory, 2=good, 3=optimal) during spinal anesthesia between two groups.|average 10-20 minutes during spinal anesthesia||||Participants|||Count of Participants
2601732|NCT02150759|Primary|Pain Score Using Five Scales|We want to compare pain score (five scales; 0=calm, 1=facial grimacing, 2=moaning, 3=screaming, 4=restlessness or agitation, unable to proceed) when patients are lateral position during spinal anesthesia.|average 10-20 minutes||||Participants|||Count of Participants
2601733|NCT02150499|Secondary|Number and Percentage of Subjects Determined to be Stabilized After Treatment|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Day 1|||||||
2601734|NCT02150499|Secondary|Change From Baseline in Pulmonary Score (Individual Component Scores) After Each Dose|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|20 minutes, 40 minutes, 60 minutes|||||||
2601735|NCT02150499|Secondary|Change From Baseline in Pulmonary Score (Total Score) After Each Dose|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|20 minutes, 40 minutes, 60 minutes|||||||
2601736|NCT02150499|Secondary|Change From Baseline in Pulmonary Score (Individual Component Scores) to End of Treatment|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Day 1|||||||
2601737|NCT02150499|Secondary|Change From Baseline in Pulmonary Score (Total Score) to End of Treatment|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Day 1|||||||
2601738|NCT02150499|Primary|The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events Leading to Discontinuation.|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Week 1||||Number of Discontinuations|||Number
2601739|NCT02150499|Primary|The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Serious Adverse Events.|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Week 1||||Number of Serious Adverse Events|||Number
2601740|NCT02150499|Primary|The Overall Safety of Treatment With Levalbuterol Tartrate HFA Inhalation Aerosol as Measured by the Number of Subjects With Treatment-emergent Adverse Events.|Due to early termination of the study, insufficient data were available to perform the statistical analyses described in the protocol. Only subject listings of disposition, demographics, medical history and safety data were provided.|Week 1||||Number of Adverse Events|||Number
2601741|NCT02150460|Primary|Pain Score for Cataract Surgery|Pain was scored on a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain|20 minutes||||units on a scale||Standard Deviation|Mean
2601742|NCT02150460|Secondary|Duration of Cataract Surgery (Minutes)|Time interval from conjunctival incision to application of eye pad|At the end of surgery||||minutes||Standard Deviation|Mean
2601743|NCT02150460|Secondary|Acceptability of the Anaesthetic Block to the Subject|Subjects were asked if they would agree to have the same anaesthetic procedure the next time they needed cataract surgery in the other eye|25 minutes||||participants|||Number
2601744|NCT02150460|Secondary|Surgeon Satisfaction Score for Local Anaesthetic Block|Surgeon subjectively scored satisfaction with the anaesthetic block on a 4 point scale: 1- poor (25%), 2 - fair (50%), 3 - good (75%), 4 - excellent (100%)|20 minutes||||units on a scale||Full Range|Median
2601745|NCT02150460|Secondary|Total Number of Injections|Total number of injections required to achieve an akinesia score of <4|15 minutes||||injections||Standard Deviation|Mean
2601746|NCT02150460|Secondary|Volume of Anaesthetic Drug (ml)|Total volume of anaesthetic drug injected into the orbit to achieve anaesthesia and akinesia adequate for cataract surgery|10 and 15 minutes||||milliliters||Standard Deviation|Mean
2601747|NCT02150460|Primary|Pain Score for Local Anaesthetic Injection|Pain was scored using a 4 point scale: 1 - no pain, 2 - mild pain, 3 - moderate pain, 4 - severe pain|20 minutes||||units on a scale||Standard Deviation|Mean
2601748|NCT02150460|Primary|Complications of Local Anaesthetic Injection|"Systemic complications: dyspnoea, bronchospasm, impaired consciousness, intravascular injection etc~Local complications: eyelid oedema, corneal oedema, conjunctival chemosis, conjunctival haemorrhage, globe perforation, vitreous haemorrhage, orbital haemorrhage etc"|0,10 and 15 minutes||||participants|||Number
2601749|NCT02150460|Primary|Supplementary Injection(s)|After 10 minutes if akinesia score was more than 3, supplementary injections were given and the effect assessed was 5 minutes later|5 minutes||||participants|||Number
2601789|NCT02149420|Secondary|VAY736 Serum Concentration - Cmax|The observed maximum serum concentration following drug administration [mass / volume]. The concentration of VAY736 was measured in the serum.|0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.|PK analysis set|||ug/mL||Full Range|Median
2601750|NCT02150460|Primary|Time Taken to Achieve Adequate Akinesia|Time taken to achieve akinesia and anesthesia adequate for surgery. Ability to move the eye in each of four directions (up, down, right and left) was scored thus: 2- normal movement, 1- reduced movement and 0- flicker or no movement. Upper eyelid akinesia was scored as 2- normal opening, 1- reduced movement and 0- complete immobility. Maximum score of 10 and minimum of 0. Adequate akinesia was defined as a total score of <4 and was evaluated at 10 and 15 minutes.|10 minutes and 15 minutes||||participants|||Number
2601751|NCT02150343|Secondary|Number of Days With no Rescue Medication Use in HDM-SPIRE Treatment Group Compared With Placebo|The number of well days, i.e., days with no moderately or severely annoying symptoms and with no rescue medication used was calculated for all subjects over a period of approximately 21 days, 50-52 weeks after randomisation.|Weeks 50 to 52 after randomisation||||Days||Standard Error|Least Squares Mean
2601752|NCT02150343|Secondary|Mean RMS in HDM-SPIRE Treatment Group Compared With Placebo|"Mean RMS (Rescue medication score) in HDM-SPIRE treatment groups compared with placebo groups.~The use of rhinoconjunctivitis rescue medications was recorded by the subject on a daily basis just before bedtime for approximately 21 days, 50-52 weeks after randomisation and was scored based on a previously published system as follows: 0 = no allergy rescue medication used per day; 0.5 = at least one dose of antihistamine eye drops used per day; 1 = at least one dose of oral antihistamine used per day; 2 = at least one dose of intranasal corticosteroid used per day; 3 = at least one dose of systemic corticosteroid used per day. The score was according to the highest level of rescue medication used and was not additive."|Weeks 50 to 52 after randomisation||||units on a scale||Standard Error|Least Squares Mean
2601753|NCT02150343|Secondary|Mean Nasal Score in HDM-SPIRE Treatment Group Compared With Placebo|"TNSS (Total nasal symptom score) was the sum of all the nasal symptom scores (runny nose; sneezing; blocked nose; itchy nose) and could range from 0 to 12. Higher TNSS reflected more severe symptoms.~Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks, 50-52 weeks after randomisation."|Weeks 50 to 52 after randomisation||||units on a scale||Standard Error|Least Squares Mean
2601754|NCT02150343|Secondary|Mean Non-nasal Score in HDM-SPIRE Treatment Group Compared With Placebo|"Mean daily Total Non-nasal Symptom Score (TNNSS) in HDM-SPIRE treatment groups compared to placebo. TNNSS was the sum of all the non-nasal symptom scores (itchy eyes; watery eyes; red eyes; sore eyes) and could range from 0 to 12. Higher TNNSS reflected more severe symptoms.~Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks, 50-52 weeks after randomisation."|Weeks 50 to 52 after randomisation||||units on a scale||Standard Error|Least Squares Mean
2601755|NCT02150343|Secondary|Mean TRSS in HDM-SPIRE Treatment Groups Compared With Placebo|"Mean Total Rhinoconjunctivitis Symptom Score (TRSS) in HDM-SPIRE treatment groups compared with placebo.~Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 non-nasal symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome), therefore TRSS could range from 0 to 24. Higher TRSS reflected more severe symptom scores. Symptoms were scored daily for a period of approximately 3 weeks, 50-52 weeks after randomisation."|Weeks 50 to 52 after randomisation||||units on a scale||Standard Error|Least Squares Mean
2601756|NCT02150343|Secondary|Participants Assessment of Change in Rhinoconjunctivitis Symptoms Measured by Rating Overall Symptoms at the End of the Study Relative to Baseline|"A Global Impression of Change in Rhinoconjunctivitis Symptoms assessment was completed by subjects at the final follow-up visit. Subjects rated their overall allergy symptoms at the end of the study relative to baseline on a seven-point scale as follows:0. very much better; 1. moderately better; 2. a little better; 3. unchanged; 4. a little worse; 5. moderately worse; 6. very much worse.~For reporting the individual categories were grouped as follows: moderately or very much better; any improvement; no change and any worsening. Subjects could therefore be reported in more than group and the total number reported does not match the overall number of participants analysed."|Weeks 50 to 52 after randomisation|The overall number of participants analysed represents the number of subjects that completed the assessment, not all subjects that completed the study (651) completed the Clinical Global Impression of Change (633).|||Participants|||Count of Participants
2601757|NCT02150343|Secondary|Mean RQLQ Score in HDM-SPIRE Treatment Groups Compared With Placebo|"The RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) was completed by subjects at the end of the study (50-52 weeks after randomisation).~RQLQ is a validated method of assessing quality of life and has 28 questions in seven domains (activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems and emotional function). Subjects recalled how their rhinoconjunctivitis had been during the last week and responded to each question on a seven-point scale (0 = no impairment, 6 = maximum impairment). Questions were equally weighted, and the RQLQ score was the mean of the 28 questions and could range from zero to six.~A higher score indicated greater impact on quality of life and thus a low score indicated a better outcome."|Weeks 50 to 52 after randomisation||||units on a scale||Standard Error|Least Squares Mean
2601758|NCT02150343|Primary|Combined Score of Symptoms and Allergy Medication|"The primary endpoint was mean Combined Score (CS) over a 3 week period (50-52 weeks after randomisation) in the HDM-SPIRE treatment groups compared with the mean CS in the placebo group. A higher score indicated more severe symptoms or greater use of allergy rescue medication and thus a low score indicated a better outcome.~CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Rescue Medication Score (RMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing, blocked nose and itchy nose and 4 non-nasal symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe); TRSS was divided by the number of symptoms (8) to provide an average score per symptom of 0-3.~The RMS score ranged from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The RMS score was not additive, and therefore the maximum RMS was 3 and the maximum CS was 6."|Weeks 50 to 52 after randomisation||||units on a scale||Standard Error|Least Squares Mean
2602967|NCT02137512|Secondary|Glucose Standard Deviation - Main Phase, Night Only|CGM Glucose Standard Deviation (SD) during study Main Phase, night only (23:00 - 07:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||mg/dL||Inter-Quartile Range|Median
2601759|NCT02150213|Primary|Incidence of Uterine Endometrial Stromal Sarcomas|Incidence of uterine endometrial stromal sarcomas as assessed by sonogram/biopsy (females)|Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212|Full Analysis Set (FAS):included all patients who signed informed consent to enter the study, but this assessment was only done on female patients. Of the 31 female patients, two had a hysterectomy and were not evaluated (N=29)|||Participants|||Number
2601760|NCT02150213|Primary|Incidence of Adrenal Cortical Adenomas|Incidence of adrenal cortical adenomas as assessed by non-contrast MRI of the abdomen (CT or ultrasound of the abdomen was permitted if MRI was contraindication)|Minimum of one year after last dose of BGG492 in study BGG492A2207 or BGG492A2212|Full analysis Set: included all patients who signed informed consent to enter the study|||Particpants|||Number
2601761|NCT02150109|Secondary|Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements|Staff obtained responses from subjects WITH and WITHOUT diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree.'|1 hour||||Number who strongly agree,agree,neutral|||Number
2601762|NCT02150109|Secondary|Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtained and tested subject (WITH and WITHOUT diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-20% across the tested YSI glucose range.|1 hour|369 (372-3) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject staff test was not performed and for one subject staff test was not evaluable due to protocol deviation.|||Blood glucose results within +/- 20%|||Number
2601763|NCT02150109|Secondary|Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtained and tested subject (WITH and WITHOUT diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-15% across the tested YSI glucose range.|1 hour|369 (372-3) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject staff test was not performed and for one subject staff test was not evaluable due to protocol deviation.|||Blood glucose results within +/- 20%|||Number
2601764|NCT02150109|Secondary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH diabetes (329) and WITHOUT diabetes (43) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-20% of the laboratory method across the entire tested YSI glucose range.|1 hour|365 (372-7) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject time between subject meter test and collection of subject reference sample exceeded time allowed in protocol. Five subjects did not obtain meter BG result after three attempts.|||Blood glucose results within +/- 20%|||Number
2601765|NCT02150109|Secondary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range|Untrained subjects WITH diabetes (329) and WITHOUT diabetes (43) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15% of the laboratory method across the entire tested YSI glucose range.|1 hour|365 (372-7) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject time between subject meter test and collection of subject reference sample exceeded time allowed in protocol. Five subjects did not obtain meter BG result after three attempts.|||Blood glucose results within +/- 15%|||Number
2601766|NCT02150109|Secondary|Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements|Staff obtained responses from persons WITH diabetes (329) using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or 'Neutral' or 'Disagree' or 'Strongly Disagree.'|1 hour||||number who strongly agree,agree,neutral|||Number
2601767|NCT02150109|Secondary|Number of Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtained and tested subject (329 WITH diabetes) fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|326 (329-3) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. One subject had no BG result obtained by study staff. One subject's staff-obtained BG result was not evaluable due to protocol deviation.|||Blood glucose results within 15mg/dL/15%|||Number
2601768|NCT02150109|Secondary|Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Study staff tested venous blood of subjects WITH diabetes (329) using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma).|1 hour|318 (329-11) Blood glucose results were analyzed. Eleven (11) subjects had unsuccessful venipuncture attempts, so no venous results were obtained for them.|||Blood glucose results within 15mg/dL/15%|||Number
2602968|NCT02137512|Secondary|Glucose Standard Deviation - Main Phase, Day and Night|CGM Glucose Standard Deviation (SD) during study Main Phase|2 weeks|One participant was excluded due to missing baseline CGM data|||mg/dL||Inter-Quartile Range|Median
2601769|NCT02150109|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Untrained subjects WITH diabetes (329) self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|324 (329-5) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject time between subject meter test and collection of subject reference sample exceeded time allowed in protocol. Three subjects did not obtain meter BG result after three attempts.|||Blood glucose results within 15mg/dL/15%|||Number
2601770|NCT02150057|Primary|Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score|The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be administered to collect patient reported outcomes as they relate to pain, function, and quality of life. The pain scale range is 0-10 with lower scores indicating less pain.|Baseline, 6 month follow-up|Only 19 patients in the control group completed the study. Only 22 patients in the experimental group completed the study.|||units on a scale||Standard Deviation|Mean
2601771|NCT02150044|Secondary|Tube Retention|Tube Retention is the presence of a TTDS-placed tympanostomy tube across the tympanic membrane (TM) at the Follow-Up visit evaluated by ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).|1 week||||ears|Participants||Number
2601772|NCT02150044|Secondary|Procedure Success|Procedure Success is the successful placement of any tympanostomy tube evaluated on a per subject basis. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).|Day 0 (at procedure visit)||||participants|||Number
2601773|NCT02150044|Primary|Ear Outcome Success|Ear Outcome Success is successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) per ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).|Day 0 (at procedure visit)||||ears|Participants||Number
2601774|NCT02149875|Secondary|Barthel Index Score|Range from 0, indicating complete dependence on help with activities of daily living, to 100, indicating independence|At 11-day and 21-day after therapy||||units on a scale||Standard Deviation|Mean
2601775|NCT02149875|Primary|National Institutes of Health Stroke Scale Score|Scores range from 0 to 42, with higher scores indicating increasing severity|At 11-day and 21-day after therapy||||units on a scale||Standard Deviation|Mean
2601776|NCT02149836|Secondary|Changes in Reward System Activation After Treatment With Ezogabine|Functional MRI of reward processing: The primary neuroimaging endpoint is the degree of change observed in the reward system in the brain. Although it was an outcome measure, the data format is a set of 4-dimensional statistical maps and not reported in raw data. Mean changes in activation of the ventral tegmental area (VTA) or ventral striatum (VS) in response to reward cue to reward receipt, and VTA mean change in beta weight in response to reward cue at 8 weeks as compared to baseline. The Z-score indicates the number of standard deviations away from a reference population in the same age range. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|baseline and post treatment (8 weeks)||||z-score||Standard Deviation|Mean
2601777|NCT02149836|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|The Columbia-Suicide Severity Rating Scale (C-SSRS) is a comprehensive, semi-structured interview measure that uniquely measures the full spectrum of suicidality including passive and active suicidal ideation, suicidal intent as well as suicidal behaviors. Full range from 0 (low intensity suicidal ideation to 9 (high intensity suicidal ideation).|8 weeks||||units on a scale||Standard Deviation|Mean
2601778|NCT02149836|Secondary|Patient Rated Inventory of Side Effects (PRISE)|Number of symptom events as reported by the patient in a self-report measure. PRISE assesses the presence of treatment side effects in nine organ/function systems (gastrointestinal, nervous system, heart, eyes/ears, skin, genital/urinary, sleep, sexual functioning, and other)|8 weeks||||events|||Number
2601779|NCT02149836|Primary|Montgomery-Asberg Depression Rating Scale Comparison to Baseline|The Montgomery-Asberg Depression Rating Scale (29) is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points. The MADRS is specifically designed to detect changes in depression severity in the context of a medication treatment trial.|baseline and after end of treatment (10 weeks)|1 participant withdrew before end of study|||units on a scale||Standard Deviation|Mean
2601780|NCT02149524|Secondary|Overall Survival (OS)||1 month after the last administration of investigational product|Per-protocol set|||percentage of subjects alive|||Number
2601781|NCT02149524|Secondary|Event-free Survival (EFS)||1 month after last dose of investigational product|Per-protocol set|||percentage of subjects without event|||Number
2601782|NCT02149524|Secondary|Overall Clinical Response Rate (ORR)||Week 24|Per-protocol set|||percentage of responders|||Number
2601783|NCT02149524|Secondary|Total Pathological Complete Response (tpCR) Rate||Week 24|Per-protocol set|||percentage of responders|||Number
2601784|NCT02149524|Primary|The Pathologic Complete Response (pCR) Rate of the Primary Breast Tumour||Week 24|Per-protocol set|||percentage of responders|||Number
2601785|NCT02149420|Primary|Overall Incidence of Adverse Events|Number of subjects with Adverse Events during the double blind treatment period.|Baseline to Week 24|Safety analysis set|||Participants|||Count of Participants
2601786|NCT02149420|Secondary|VAY736 Serum Concentration - Vz|The volume of distribution during the terminal elimination phase following intravenous administration [volume]. The concentration of VAY736 was measured in the serum.|0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.|PK analysis set|||L||Full Range|Median
2601787|NCT02149420|Secondary|VAY736 Serum Concentration - Tmax|The time to reach the maximum concentration after drug administration [time]. The concentration of VAY736 was measured in the serum.|0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.|PK analysis set|||hours||Full Range|Median
2601788|NCT02149420|Secondary|VAY736 Serum Concentration - T1/2|Apparent terminal half-life, determined as the ln2/lambda_z or 0.693/lambda_z. The concentration of VAY736 was measured in the serum.|0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.|PK analysis set|||days||Full Range|Median
2601790|NCT02149420|Secondary|VAY736 Serum Concentration - CL|The systemic (or total body) clearance from serum following intravenous administration [volume / time]. The concentration of VAY736 was measured in the serum.|0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.|PK analysis set|||L/day||Full Range|Median
2601791|NCT02149420|Secondary|VAY736 Serum Concentration - AUClast|The area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration [mass × time / volume]. The concentration of VAY736 was measured in the serum.|0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.|PK analysis set|||day*ug/mL||Full Range|Median
2601792|NCT02149420|Secondary|VAY736 Serum Concentration - AUCinf|The area under the serum concentration-time curve from time zero to infinity [mass × time / volume]. The concentration of VAY736 was measured in the serum.|0, 1, 2, 3, 6, 9, 12, 16, 20, 24 and approximately 52 weeks.|PK analysis set|||day*ug/mL||Full Range|Median
2601793|NCT02149420|Secondary|Change in the Patient's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS)|"The visual analogue scale used is a 100 mm VAS ranging from no disease (0 mm) to maximal disease activity (100 mm)."|Baseline, week 12|PD analysis set|||units on a scale||Standard Deviation|Mean
2601794|NCT02149420|Secondary|Change in the Physician's Global Assessment of Overall Disease Activity by Means of Visual Analog Scale (VAS)|"The visual analogue scale used is a 100 mm VAS ranging from no disease (0 mm) to maximal disease activity (100 mm)."|Baseline, week 12|PD analysis set|||units on a scale||Standard Deviation|Mean
2601795|NCT02149420|Secondary|Change in Multidimensional Fatigue Inventory (MFI)|The MFI is a patient self-reported outcome measure (questionnaires) to assess fatigue covering the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Each dimension has a posible range from 4-20. A reduction from baseline in MFI indicates improvement.|Baseline, week 12|PD analysis set|||units on a scale||Standard Deviation|Mean
2601796|NCT02149420|Secondary|Change in Short Form (36) Health Survey (SF-36)|The SF-36 is a 36-item, patient self-reported outcome measure (questionnaires) of patient health. The outcome of the questionnaires in eight scales results in two summary scores, physical component and mental component, both ranging from 0 - 100. An increase from baseline in either component summary score indicates reduced disease burden.|Baseline, week 12|PD analysis set|||units on a scale||Standard Deviation|Mean
2601797|NCT02149420|Secondary|Change in EULAR Sjögren's Syndrome Patient Response Index (ESSPRI)|The ESSPRI is a patient self-reported outcome measure to assess dryness, limb pain, fatigue and mental fatigue, where each of the domains normally reported as 0 (not at all) to 10 (extremely severe). The final ESSPRI score is the average of three: dryness, pain and fatigue. A reduction from baseline indicates the improvement of symptoms. During the study all individual scores were reported as 1 to 10 instead. A linear transformation was reported to map the scores to the range of 0-10.|Baseline, week 12|PD analysis set|||units on a scale||Standard Deviation|Mean
2601798|NCT02149420|Primary|Change in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)|The effect of VAY736 on clinical disease activity was measured by the change in ESSDAI (EULAR Sjögren's syndrome disease activity index) between baseline and week 12. The instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score (range 0-123). A reduction from baseline indicates improvement in patients.|Baseline, week 12|PD analysis set|||units on a scale||Standard Deviation|Mean
2601799|NCT02149342|Other Pre-specified|Clearance of Field Cancerization in Hyperspectral Images|Data not collected|3 months|||||||
2601800|NCT02149342|Secondary|Pain Assesment (Visual Analog Scale)|Pain using visual analog scale (VAS 0-10, where 0 is no pain and 10 is the worst pain imaginable) on both treatment sides is assessed in every 30 minutes during 2-hour sun-exposure and afterwards once in two hours until 9 p.m. (treatment day). Of these values, the mean maximal pain is assessed.|12 hours||||Mean maximal pain VAS score||Full Range|Mean
2601801|NCT02149342|Secondary|Adverse Reactions|Adverse reactions are evaluated by blinded observer at one week after treatment. Severity of the reaction ( Redness, crusting and scaling) is assessed using grading: minimal, mild, intermediate, severe.|One week||||participants|||Number
2601802|NCT02149342|Secondary|Clinical Lesion Clearance|Clinical lesion clearance is observed by a blinded observer|Baseline, 3 months||||percentage of lesions in complete respon|Participants|Full Range|Mean
2601803|NCT02149342|Primary|Histological Lesion Clearance|Punch biopsies were taken symmetrically on both treatment fields from equally graded >6 mm AKs prior to treatment and again at 3 months, blinded observer (pathologist). HE- and p53-stainings. Samples not fulfilling the criteria of an AK were defined as healthy or completely cleared. The p53 reactivity expressed as average percentage of positive nuclei in three consecutive high power fields from the region of highest reactivity (<10 % normal)|Baseline, 3 months|One patient was excluded from the histological analysis because one biopsied lesion clinically taken as an AK appeared histologically to be seborrheic eczema.|||percentage of complete histological clea|Participants|Full Range|Mean
2601804|NCT02149303|Primary|Index Event Characteristics (i.e. Type of Bleeding and Anatomic Locations of the Index Event) at the Time of the ED / ER Presentation or Hospitalization|"Proportion of Index events by anatomic location and type are presented. The categories of Unknown and Other presented below correspond to, Unknown: Unknown location of bleeding met the criteria for major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH).~Other: Other types of bleeding represent a combined category of all other locations of bleeding whose incidence was <1.7%."|From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days|Patients who received treatment at the five study sites|||Percentage of events|||Number
2601805|NCT02149303|Primary|Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release|Proportion of subjects receiving different types of interventions (i.e., medication / procedure and surgery) to manage the index events until their hospital discharge / release.|From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days|Patients who received treatment at the five study sites|||Percentage of participants|||Number
2601806|NCT02149303|Primary|Proportion of Subjects With Index Event Safety Outcomes (Resolved / Recovery Ongoing / Deceased) at the Time of Their Hospital Discharge / Release.|Proportion of subjects with index event safety outcomes (resolved / recovery ongoing / deceased) at the time of their hospital discharge / release.|From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days|Patients who received treatment at the five study sites|||Percentage of participants|||Number
2601807|NCT02149264|Secondary|Pharmacokinetic Parameter - Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone|A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.|Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Of 155 subjects, one subject discontinued due to an adverse event after Day 14 visit and not included in the analysis.|||ng/dL||Standard Deviation|Mean
2601808|NCT02149264|Secondary|Pharmacokinetic Parameter - Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone|A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.|Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Of 155 subjects, one subject discontinued due to an adverse event after Day 14 visit and not included in the analysis.|||ng/dL||Standard Deviation|Mean
2601809|NCT02149264|Secondary|Pharmacokinetic Parameter - Time at Which the Maximum Concentration Occurs (Tmax) for Total Testosterone and Dihydrotestosterone|A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.|Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Of 155 subjects, one subject discontinued due to adverse event after Day 14 visit and not included in the analysis.|||hr||Full Range|Median
2601810|NCT02149264|Secondary|Pharmacokinetic Parameter - Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone|A validated LC/MS/MS method was used to determine the levels of total testosterone and dihydrotestosterone.|Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Number of subjects was less than 155 in some group(s) as parameter could not be calculated due to missing concentrations for that time-point.|||ng*hr/dL||Standard Deviation|Mean
2601811|NCT02149264|Secondary|Pharmacokinetic Parameter - Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone|A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone and dihydrotestosterone.|Samples collected at pre-dose, 2, 4, 6, 8 & 24 hours post-dose on Days 14, 35 & 56, and at pre-dose, 2, 4, 6, 8, 10, 12, 18 & 24 hours post-dose on Day 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons. Number of subjects was less than 155 in some group(s) as parameter could not be calculated due to missing concentrations for that time-point.|||ng/dL||Standard Deviation|Mean
2601812|NCT02149264|Secondary|Change From Baseline in Short Form-12 Health Survey (SF-12) Score|"Data collected from the SF-12 questionnaire, based on the norm-based scores was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contained four sub-domains:~PCS:~Physical Functioning (2 items, questions 2-3)~Role-Physical (2 items, questions 4-5)~Bodily Pain (1 item, question 8)~General Health (1 item, question 1)~MCS:~Vitality (1 item, question 10)~Social Functioning (1 item, question 12)~Role-Emotional (2 items, questions 6-7)~Mental Health (2 items, questions 9 and 11)~PCS and MCS composite scores are computed using the scores of the 12 questions and range from 0-100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Positive change from baseline indicated improvement in physical and mental health."|At Days 35 and 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.|||units on a scale||Standard Deviation|Mean
2601813|NCT02149264|Secondary|Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score|"The MAF contains four sub-domains:~Severity (2 items, questions 1-2) (Score range: 2-20)~Distress (1 item, question 3) (Score range: 1-10)~Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110)~Timing (2 items, questions 15-16) (Score range: 5-20)~A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain (categorical in nature) are scored from 1-4. The scores are converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.~To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. The GFI ranged from 1 (no fatigue) to 50 (severe fatigue)."|At Days 35 and 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.|||units on a scale||Standard Deviation|Mean
2601828|NCT02149199|Secondary|Change From Baseline in the Percentage of Nighttime Awakenings Due to Asthma|Night-time awakenings (%) due to asthma change from baseline. Variable analysed is the proportion (%) of nights during the relevant period with night-time awakenings. Baseline refers to the last 10 nights of the run-in period.|up to 52 weeks|Full analysis set.|||% of nights||Standard Deviation|Mean
2601814|NCT02149264|Secondary|Change From Baseline in International Index of Erectile Function (IIEF) Score|"Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains were:~Erectile function (6 items, questions 1-5 and 15) (Score range:1-30)~Orgasmic function (2 items, questions 9-10) (Score range: 0-10)~Sexual desire (2 items, questions 11-12) (Score range: 2-10)~Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)~Overall satisfaction (2 items, questions 13-14) (Score range: 2-10)~A score of 0-5 is awarded to questions 1 to 10 and a score of 1-5 is awarded to questions 11 to 15. Total score was calculated by summing up scores of each domain and ranged from 5 to 75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function."|At Days 35 and 90|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.|||units on a scale||Standard Deviation|Mean
2601815|NCT02149264|Secondary|The Percentage of Subjects Whose Cave(0-24) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL|The data were presented using descriptive statistics. No statistical analysis was performed.|At 14, 35 and 56|FAS population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.|||percentage of subjects|||Number
2601816|NCT02149264|Primary|The Percentage of Subjects Whose Average Concentration (Cave(0-24)) Serum Total Testosterone Levels Are ≥300 and ≤1050 ng/dL|The data were presented using descriptive statistics. The 95% confidence interval (CI) of the proportion (response) was estimated using the normal approximation to the binomial distribution. The study was considered to have met its efficacy criteria if the percentage was ≥ 75% and the lower bound of the 95% CI was ≥ 65%.|At Day 90|Full Analysis Set (FAS) population was used and included subjects who had sufficient pharmacokinetic data to determine a Cave(0-24) on Days 14, 35, 56, or 90, or discontinued the study early due to medical or safety reasons.|||percentage of subjects||95% Confidence Interval|Number
2601817|NCT02149199|Secondary|Annual Moderate or Severe Asthma Exacerbation Rate|Moderate or severe asthma exacerbations during the randomised treatment period.|up to 52 weeks|Full analysis set|||exacerbations per year||95% Confidence Interval|Least Squares Mean
2601818|NCT02149199|Secondary|Annual Severe Asthma Exacerbation Rate|Severe asthma exacerbations over the randomised treatment period.|up to 52 weeks|Full analysis set|||exacerbations per year||95% Confidence Interval|Least Squares Mean
2601819|NCT02149199|Secondary|Percentage of Controller Use Days|ICS controller use days (%) during the randomised treatment period is calculated as the cumulative number of days when any controller medication (containing ICS) was taken including maintenance (Pulmicort bid group) and 'as needed' medication (Symbicort 'as needed' group) and additional prescribed ICS for asthma exacerbations and/or long term poor asthma control (all treatment groups), divided by the number of days in the randomised treatment period.|up to 52 weeks|Full analysis set.|||% of days||Standard Deviation|Mean
2601820|NCT02149199|Secondary|Average Change From Baseline in Asthma Quality of Life Questionnaire; Standard Version (AQLQ(S))|Asthma Quality of Life Questionnaire Standardised Version (AQLQ (S) overall score change from baseline. AQLQ(S) consists of 32 questions in 4 domains. Each question is assessed on a 7-point scale from 1 to 7, with higher values indicating better health-related quality of life. The overall score is calculated as the mean score of all 32 items.|Study weeks 0,16,28,40,52|Full analysis set.|||units on a scale||95% Confidence Interval|Least Squares Mean
2601821|NCT02149199|Secondary|Average Change From Baseline in Asthma Control Questionnaire (ACQ-5)|Asthma Control Questionnaire 5-item version score change from baseline. ACQ questionnaire contains five questions on patients' symptoms, which are assessed on a 7-point scale from 0 (representing good control) to 6 (representing poor control). The score is the mean score of all questions for which responses are provided.|Study weeks 0,4,16,28,40,52|Full analysis set.|||units on a scale||95% Confidence Interval|Least Squares Mean
2601822|NCT02149199|Secondary|Number of Participants Experiencing at Least One Occasion With Additional Steroids for Asthma|Additional steroids for asthma includes any additional inhaled and/or systemic glucocorticosteroids treatment due to asthma while in the randomised treatment period.|Day 1 up to 52 weeks|Full analysis set|||Participants|||Number
2601823|NCT02149199|Secondary|Poorly Controlled Asthma Weeks|A poorly-controlled asthma week is defined as a week meeting any one of the following conditions: Two or more consecutive days with awakenings due to asthma on both nights; A recorded use of 'as needed' medication for symptom relief of at least 3 occasions per day, for at least 2 consecutive days; Additional systemic GCS treatment required for severe exacerbation. If there were sufficient data within a week available to confirm the week was not poorly-controlled, the week is labelled as 'does not meet criteria for poorly-controlled'.|Weekly for up to 52 weeks|Full analysis set|||weeks||Standard Deviation|Mean
2601824|NCT02149199|Secondary|Number of Patients With Study Specific Asthma Related Discontinuation|Study specific asthma related discontinuation|up to 52 weeks|Full Analysis Set|||Participants|||Number
2601825|NCT02149199|Secondary|Change From Baseline in Percentage of Asthma Control Days|Asthma control days (%) change from baseline. An asthma control day is defined as the fulfilment of all of the following criteria; a day and night with no asthma symptoms, a night with no awakenings due to asthma symptoms and a day and night with no use of 'as needed' medication. Variable analysed is the proportion (%) of asthma control days during the randomised treatment period. Baseline refers to the last 10 days of the run-in period.|up to 52 weeks|Full analysis set|||% of days||Standard Deviation|Mean
2601826|NCT02149199|Secondary|Change From Baseline in Percentage of 'As Needed' Free Days|'As needed' free days (%) change from baseline during the randomised treatment period. An 'as needed' free day is defined as a day and night with no use of 'as needed' medication. Variable analysed is the proportion (%) of 'as needed' free days during the relevant period. Baseline refers to the last 10 days of the run-in period.|up to 52 weeks|Full analysis set|||% of days||Standard Deviation|Mean
2601827|NCT02149199|Secondary|Change From Baseline in Percentage of Symptom-free Days|Symptom-free days (%) change from baseline during the randomised treatment period.Variable analysed is the proportion (%) of symptom-free days during the relevant period. Baseline refers to the last 10 days of the run-in period.|up to 52 weeks|Full analysis set|||% of days||Standard Deviation|Mean
2602969|NCT02137512|Secondary|Glucose Coefficient of Variation - Main Phase, Day Only|CGM Glucose Coefficient of Variation (CV) during study Main Phase, day only (07:00 - 23:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage||Inter-Quartile Range|Median
2601829|NCT02149199|Secondary|Average Change From Baseline in Asthma Symptom Score|Asthma symptom score (eDiary) change from baseline during the randomised treatment period. Symptom score is entered morning and evening by the patient on a 4-point scale from 0 to 3 with higher values indicating more severe symptoms. Asthma symptom score is then the sum of the day and night scores, which implies a range of scores from 0 - 6, with higher values indicating more severe symptoms. Baseline is defined as the mean of all non-missing measurements during the last 10 days of the run-in period.|up to 52 weeks|Full analysis set|||units on a scale||95% Confidence Interval|Least Squares Mean
2601830|NCT02149199|Secondary|Average Change From Baseline in Number of Inhalations of 'as Needed' Medication.|'As needed' inhalations change from baseline over the randomised treatment period. Baseline is defined as the last 10 days of the run-in period. 'As needed' use was calculated as the cumulative doses of 'as needed' medication over the randomised treatment period divided by the follow-up time (number of days - 1). ie, average number of inhalations per day.|up to 52 weeks|Full analysis set.|||Number of inhalations per day||Standard Deviation|Mean
2601831|NCT02149199|Secondary|Average Change From Baseline in Evening PEF|Evening peak expiratory flow (eDiary) change from baseline during the randomised treatment period. Baseline is defined as the mean of all non-missing evening measurements during the last 10 days of the run-in period.|up to 52 weeks|Full analysis set|||L/min||95% Confidence Interval|Least Squares Mean
2601832|NCT02149199|Secondary|Average Change From Baseline in Morning Peak Expiratory Flow (PEF)|Morning peak expiratory flow (eDiary) change from baseline over the randomised treatment period. Baseline is defined as the mean of all non-missing morning measurements during the last 10 days of the run-in period.|up to 52 weeks|Full analysis set.|||L/min||95% Confidence Interval|Least Squares Mean
2601833|NCT02149199|Secondary|Average Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1)|Overall estimate of FEV1 (mL) pre-bronchodilator change from baseline. Baseline is the measurement at Visit 3 (prior to first dose of Investigational Product) from MMRM (mixed model repeated measures analysis).|Study weeks 0,4,16,28,40,52|Full analysis set.|||mL||95% Confidence Interval|Least Squares Mean
2601834|NCT02149199|Secondary|Number of Participants Experiencing at Least One Moderate or Severe Asthma Exacerbation|"A moderate exacerbation is defined as a deterioration of asthma requiring a change in treatment, i.e. initiation of prescribed additional ICS treatment to avoid progression of the worsening of asthma to a severe exacerbation.~A severe exacerbation is defined as a deterioration of asthma requiring any of the following: use of systemic glucocorticosteroids (GCS) for at least 3 days, inpatient hospitalization, or emergency room visit due to asthma that required systemic steroids"|Day 1 up to 52 weeks|Full analysis set|||Participants|||Number
2601835|NCT02149199|Secondary|Number of Participants Experiencing at Least One Severe Asthma Exacerbation|A severe exacerbation is defined as a deterioration of asthma requiring any of the following: use of systemic glucocorticosteroids (GCS) for at least 3 days, inpatient hospitalization, or emergency room visit due to asthma that required systemic steroids|Day 1 up to 52 weeks|Full analysis set|||Participants|||Number
2601836|NCT02149199|Primary|'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No)|A well-controlled asthma week is defined as the fulfilment of both conditions A) and B) below: A) Two or more of the following criteria are fulfilled: − No more than 2 days with a daily asthma symptom score >1 − No more than 2 days of 'as needed' medication use, up to a maximum of 4 occasions per week (multiple occasions per day should be regarded as separate occasions) − Morning PEF ≥80% of Predicted Normal every day B) Both of the following criteria are fulfilled: − No nighttime awakenings due to asthma − No additional inhaled and/or systemic glucocorticosteroid treatment due to asthma. The binary variable well-controlled asthma week was derived for each patient and study week. In addition, for each week, the percent of patients with well-controlled asthma week was derived. It is required that the eDiary had to be completed on at least 5 days in a week to be a well-controlled asthma week.|Weekly, up to 52 weeks|Full analysis set. Patients with no evaluable weeks are not included in the analysis.|||Percentage||Standard Deviation|Mean
2601837|NCT02149173|Secondary|Time to Disease Progression|Months from the start of endocrine therapy to the time the patient is first recorded as having disease progression,|from start of therapy up to 20 years||||months||Full Range|Median
2601838|NCT02149173|Primary|Proportion of Patients Experienced a Threshold in Percentage Change, or Surpassed a Targeted Follow-up F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV)|The number of patients showing a 20% increase in FES SULgmean compared to baseline at either 2 or 8 weeks using a 90% Wilson score binomial confidence interval.|from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks)|The patient arms different from Primary Outcome 1 because they are separated according to the type of therapy each group had (ER modulating or ER blocking), not by the number of FES scans that they had. Results are based on the change between 2 scans.|||Proportion of participants||90% Confidence Interval|Number
2601839|NCT02149173|Primary|F-18 16 Alpha-fluoroestradiol (FES) Uptake|Quantitative and qualitative measures of FES uptake for each disease site, a set of 1.5 cm diameter regions on three adjacent planes with the highest lesion FES uptake will be drawn to determine maximal FES uptake. Up to 10 sites seen on the static torso survey will be quantified. Lesions will qualitatively determined to be visible or not visible.|from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks)|quantitative and qualitative measure of FES positive lesions|||number of ER+ lesions|number of ER+ lesions||Count of Units
2601840|NCT02149173|Primary|Change in F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV), Assessed by a One-sample Test of the Percent Change in FES SUV|Uptake was quantified using lean body mass adjusted SUV (SULmean). The geometric mean was calculated for up to 3 lesions per patient. Systematic change in FES SULgmean between baseline and a second FES scan at approximately 2 or 8 weeks and a third FES scan was at approximately 8 weeks measured using a sign test where the median change is zero.|from time of first F-18 FES-PET/CT scan to time of second or third F-18 FES-PET/CT scan (approximately 2-8 weeks)|15/23 patients underwent a second FES PET/CT scan approximately 2 wks after starting potential ER modulating (vorinostat) therapy. 14/23 underwent a second or third FES PET/CT scan approximately 8 wks after starting vorinostat therapy. 6 patients underwent a second FES PET/CT scan between 2-8 wks after starting potential ER blocking therapy.|||percentage of change in SULgmean||Full Range|Median
2603041|NCT02136004|Primary|Rate of Combined Major Access Site Closure-related Complications|Primary safety endpoint - rate of combined major access site closure-related complications|Through 30 days +/- 7 days|All subjects enrolled|||complications|||Number
2601841|NCT02149108|Secondary|Disease Control (Complete Response + Partial Response + Stable Disease) by Central Review Assessment|Disease control was defined as best overall response of CR, PR, or Stable Disease (SD).|From randomisation until cut-off date 14JUN2016.|Randomised Set: This patient set included all patients who were randomised to receive treatment, whether treated or not.|||Percentage of participants|||Number
2601842|NCT02149108|Secondary|Objective Tumour Response (Complete Response (CR)) + Partial Response (PR) by Central Review Assessment|Objective tumour response was defined as best overall response of CR or PR determined by central review assessment.|From randomisation until cut-off date 14JUN2016.|Randomised Set: This patient set included all patients who were randomised to receive treatment, whether treated or not.|||Percentage of participants|||Number
2601843|NCT02149108|Primary|Overall Survival (OS)|"OS was defined as the time from randomisation to the time of death from any cause.~Median, 95% Confidence Interval were calculated from an unadjusted Kaplan−Meier curve for each treatment arm."|From randomisation until cut-off date 14JUN2016.|Randomised Set: This patient set included all patients who were randomised to receive treatment, whether treated or not.|||Months||95% Confidence Interval|Median
2601844|NCT02149108|Primary|Progression-Free Survival (PFS) by Central Review Assessment|"PFS by central review assessment was defined as the time from the date of randomisation to the date of disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 or death from any cause, whichever occurred first.~Median, 95% Confidence Interval were calculated from an unadjusted Kaplan−Meier curve for each treatment arm."|From randomisation until cut-off date 14JUN2016.|Randomised Set: This patient set included all patients who were randomised to receive treatment, whether treated or not.|||Months||95% Confidence Interval|Median
2601845|NCT02148952|Other Pre-specified|Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start|"Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at any time during the observation period, 12 months post-intervention start."|12 months post-intervention start|The denominator for this analysis is all women who were observed at anytime, 12 months post-intervention start in the site.|||Participants|||Count of Participants
2601846|NCT02148952|Other Pre-specified|Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start|"Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one hour after delivery, 12 months post-intervention start"|12 months post-intervention start|The denominator for this analysis is all women who were observed within one hour after delivery, 12 months post-intervention start in the site.|||Participants|||Count of Participants
2601847|NCT02148952|Other Pre-specified|Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start|"Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one minute after delivery, 12 months post-intervention start"|12 months post-intervention start|The denominator for this analysis is all women who were observed within one minute after delivery, 12 months post-intervention start in the site.|||Participants|||Count of Participants
2601848|NCT02148952|Other Pre-specified|Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start|"Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time just before pushing, 12 months post-intervention start"|12 months post-intervention start|The denominator for this analysis is all women who were observed at the time just before pushing, 12 months post-intervention start in the site.|||Participants|||Count of Participants
2601849|NCT02148952|Other Pre-specified|Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start|"Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of the woman's admission to the facility, 12 months post-intervention start."|12 months post-intervention start|The denominator for this analysis is all women who were observed at admission, 12 months post-intervention start in the site.|||Participants|||Count of Participants
2601850|NCT02148952|Other Pre-specified|Mean Number of 18 Essential Birth Practices Performed at 12 Months Post-intervention Start|"Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the mean number of 18 essential birth practices performed across the intervention versus control facilities at 12 months post-intervention start."|12 months post-intervention start|The denominator for this analysis is all women who were observed for at least one pause point 12 months post-intervention start in the site.|||essential birth practices performed||95% Confidence Interval|Mean
2601851|NCT02148952|Other Pre-specified|Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start|"Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at anytime during the observation period of the woman's delivery, 2 months post-intervention start."|2 months post-intervention start|The denominator for this analysis is all women who were observed at any time during delivery, 2 months post-intervention start in the site.|||Participants|||Count of Participants
2601867|NCT02148952|Secondary|Count of Participants With Stillbirth|Newborn outcome; rate of stillbirth|0-7 days after delivery|The denominator for this analysis is all women who had non-missing information about whether their baby(s) experienced stillbirth.|||Participants|||Count of Participants
2601852|NCT02148952|Other Pre-specified|Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start|"Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one hour after delivery, 2 months post-intervention start."|2 months post-intervention start|The denominator for this analysis is all women who were observed at one hour after delivery, 2 months post-intervention start in the site.|||Participants|||Count of Participants
2601853|NCT02148952|Other Pre-specified|Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start|"Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time within one minute after the woman's delivery, 2 months post-intervention start."|2 months post-intervention start|The denominator for this analysis is all women who were observed within one minute after delivery, 2 months post-intervention start in the site.|||Participants|||Count of Participants
2601854|NCT02148952|Other Pre-specified|Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start|"Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of labor just before pushing, 2 months post-intervention start."|2 months post-intervention start|The denominator for this analysis is all women who were observed at the time of labor just before pushing, 2 months post-intervention start in the site.|||Participants|||Count of Participants
2601855|NCT02148952|Other Pre-specified|Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start|"Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of the woman's admission to the facility, 2 months post-intervention start."|2 months post-intervention start|The denominator for this analysis is all women who were observed at admission, 2 months post-intervention start in the site.|||Participants|||Count of Participants
2601856|NCT02148952|Other Pre-specified|Mean Number of 18 Essential Birth Practices Performed at 2 Months Post-intervention Start|"Birth attendant's rate of completion of Process measures resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the mean number of 18 essential birth practices performed across the intervention versus control facilities at 2 months post-intervention start."|2 months post-intervention start|The denominator for this analysis is all women who were observed for at least one pause point 2 months post-intervention start in the site.|||essential birth practices performed||95% Confidence Interval|Mean
2601857|NCT02148952|Secondary|Count of Newborns Returning to Facility for a Health Problem Within 7 Days|Newborn outcome; Rate of need for follow-up care for newborn (or at least one newborn in case of twins)|0-7 days after delivery|The denominator for this analysis is all women who had non-missing information about status of at least one baby returning to the facility for a health problem within 7 days.|||Participants|||Count of Participants
2601858|NCT02148952|Secondary|Count of Mothers Returning to Facility for a Health Problem Within 7 Days|Maternal Outcome; Rate of need for follow-up care for Mother|0-7 days after delivery|The denominator for this analysis is all women who had non-missing information about returning to a health facility for a health problem within 7 days.|||Participants|||Count of Participants
2601859|NCT02148952|Secondary|Count of Participants With Blood Transfusion Within 7 Days|Rate of blood transfusion within 7 days|0-7 days after delivery|The denominator for this analysis is all women who had non-missing information about their status regarding blood transfusion within 7 days.|||Participants|||Count of Participants
2601860|NCT02148952|Secondary|Count of Participants With Hysterectomy Within 7 Days|Rate of hysterectomy within 7 days|0-7 days after delivery|The denominator for this analysis is all women who had non-missing information about their hysterectomy status within 7 days.|||Participants|||Count of Participants
2601861|NCT02148952|Secondary|Count of Participants With Newborn Referral|Newborn outcome; Newborn referral|0-7 days after delivery|The denominator for this analysis is all women who had non-missing information about their newborn(s) referral status.|||Participants|||Count of Participants
2601862|NCT02148952|Secondary|Count of Participants With Maternal Referral, Before or After Delivery|Maternal outcome; Rate of maternal inter-facility transfer|0-7 days after delivery|The denominator for this analysis is all women who had non-missing information about their status regarding referral before and after delivery.|||Participants|||Count of Participants
2601863|NCT02148952|Secondary|Count of Participants With Cesarean Section|Rate of cesarean section|Around the time of delivery during facility stay, an expected average of 2 days (although individual patients may vary)|The denominator for this analysis is all women who had non-missing information about whether they had a cesarean section.|||Participants|||Count of Participants
2601864|NCT02148952|Secondary|Count of Participants With Severe Maternal Complications|Maternal outcome; any severe maternal complication within 7 days|0-7 days after delivery|"The denominator for this analysis is all women who had non-missing information about each morbidity. Not every respondent answered each question, so each row has a different denominator. Only women who answered all specific morbidity questions were incorporated into the participant count for any maternal severe complication within 7 days."|||Participants|||Count of Participants
2601865|NCT02148952|Secondary|Count of Participants With Maternal Death|Maternal outcome; rate of maternal death|0-7 days after delivery|The denominator for this analysis is all women who had non-missing information about maternal death status.|||Participants|||Count of Participants
2601866|NCT02148952|Secondary|Count of Participants With Early Neonatal Death|Newborn outcome; rate of early neonatal death|0-7 days after delivery|The denominator for this analysis is all women who had non-missing information about whether their baby(s) experienced neonatal death.|||Participants|||Count of Participants
2601868|NCT02148952|Secondary|Count of Participants With Perinatal Death Within 7 Days|Count of participants with perinatal death within 7 days (combined stillbirth or neonatal death)|0-7 days|There is a discrepancy between the denominator of each primary and secondary outcome because there were a different number of newborns than mothers in the trial. Additionally, we do not have data on every participant for every question. As such, the denominator is specific for each outcome.|||Participants|||Count of Participants
2601869|NCT02148952|Secondary|Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days|Percentage of participants with composite rate of perinatal death and maternal death within 7 days|0-7 days after delivery|The denominator for this analysis is all women who had non-missing information about their death, and their baby(s)|||percentage of women and newborns|||Number
2601870|NCT02148952|Primary|Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days|The primary outcome was a composite outcome of events occurring within the first 7 days after delivery, incorporating stillbirth; early neonatal death; maternal death; or self-reported maternal severe complications, including seizures, loss of consciousness for more than 1 hour, fever with foul-smelling vaginal discharge, hemorrhage, or stroke.|0-7 days after delivery|The denominator for this analysis is all women who had non-missing information about their death, their baby(s) and their morbidity.|||percentage of women/newborn dyads|||Number
2601871|NCT02148874|Secondary|Infant HAI Antibody Titers|Infant influenza antibody titers from hemagglutination inhibition (HAI) assay|cord blood at delivery|Cord blood from participating pregnant women with cord blood data available. There was only one cord blood sample per participant in this study.|||Titer||95% Confidence Interval|Geometric Mean
2601872|NCT02148874|Primary|Maternal HAI Antibody Titers|Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay|at delivery|Pregnant women with antibody titer data at delivery. Analyses include all women with available antibody titer data at the necessary time points.|||Titer||95% Confidence Interval|Geometric Mean
2601873|NCT02148874|Primary|Maternal HAI Antibody Titers|Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay|30-days after influenza vaccination|Pregnant women with antibody titer data at 30 days post vaccination. Analyses include all women with available antibody titer data at the necessary time points.|||Titer||95% Confidence Interval|Geometric Mean
2601874|NCT02148835|Secondary|Safety and Palatability of the Study Sausage|"Serious adverse events (SAE) not necessarily ending study participation are:~hospitalizations and surgical procedures~life-threatening events and accidents~Events leading to permanent damage to study participants,~Moreover, all other medical events will be recorded. All events qualifying as AE or SAE, according to Good Clinical Practice, will be recorded and reported to the ethic´s committee."|10 weeks|||||||
2601875|NCT02148835|Primary|HS-Omega-3 Index at Baseline and End of Study|The HS-Omega-3 Index is the percentage of EPA+DHA in erythrocytes, as assessed with a highly standardized analytical procedure. Since the HS-Omega-3 Index correlates with tissue EPA+DHA, it represents an individual's status in EPA+DHA.|baseline and 8 weeks|As recruited.|||HS-Omega-3 Index||Standard Deviation|Mean
2601876|NCT02148809|Other Pre-specified|Change IN Plasma Volume PV|"An indicator dilution technique was used to measure the blood volume, plasma volume and red cell blood volume. Approved by the Food and Drug Administration in 1998, the BVA-100 blood volume analyzer (Daxor Corp.) is a semi-automated system for blood volume analysis. Prepared standards and injectates were used. The injectate consists of 31I-labeled HSA (370- 1,295 kBq [10-30 mCi]) in saline.~Measurement was performed directly before surgery in the holding area and 6 hours after surgery.~Each time, before injection of the tracer a baseline sample was taken. After injection of the tracer via standard i.v. line, the first sample was drawn from an arterial line after 12 minutes waiting time. Afterwards every 6 minutes a sample was taken. In a whole 5 samples were sent for analysis to Daxor® Corp.. Each sample is counted in duplicate."|preoperative and 6 hours postoperatively||||ml||Standard Deviation|Mean
2601877|NCT02148809|Primary|Change in Total Blood Volume|The primary outcome is the change in total blood volume (TBV) during the first 6 hours after primary THA utilizing hypotensive anesthesia. Preoperative TBV will be compared to values 6 hours postoperatively.|preoperatively and 6 hours postoperatively||||ml||Standard Deviation|Mean
2601878|NCT02148718|Secondary|Percentage of Participants With Clinical Response at Day 4 or Week 12 and Clinical Remission at Week 12|The percentage of participants with clinical response (defined as decrease of at least 3 points in HBI score) at Day 4 or Week 1 and clinical remission (defined as a HBI < 5) at Week 12.|Up to Week 12|ITT population|||percentage of participants|||Number
2601879|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fibrinogen|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||mg/dL||Standard Deviation|Mean
2601880|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: International Normalized Ratio (INR)|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||ratio||Standard Deviation|Mean
2601881|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: Activated Partial Thromboplastin Time (aPTT)|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||sec||Standard Deviation|Mean
2601904|NCT02148445|Secondary|Cotinine (Continued Smokers Only)|Cotinine over 12 months, adjusted for creatinine. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and cotinine. This analysis looks at NNAL among continuing smokers only.|Month 3, Month 6, Month 12|n=4 deceased participants were excluded from analysis, non-smokers at each time point excluded|||ng/mg creatinine||Standard Deviation|Geometric Mean
2601882|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fecal Calprotectin|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||mg/kg||Standard Deviation|Mean
2601883|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: C-reactive Protein (CRP)|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||U/L||Standard Deviation|Mean
2601884|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: Sedimentation Rate (ESR)|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||mm/1h||Standard Deviation|Mean
2601885|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: Erythrocytes|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||cellsx10^6/uL||Standard Deviation|Mean
2601886|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||cellsx10^3/uL||Standard Deviation|Mean
2601887|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hematocrit|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||% volume||Standard Deviation|Mean
2601888|NCT02148718|Secondary|Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hemoglobin|Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes sedimentation rate (ESR), C-reactive protein (CRP), fecal calprotectin, and coagulation (activated partial thromboplastin time [aPTT], international normalized ratio [INR], and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||g/dL||Standard Deviation|Mean
2601889|NCT02148718|Secondary|Fatigue Impact Scale for Daily Use (D-FIS): Change From Baseline to Week 12|The D-FIS is used to measure the impact of fatigue on the daily lives of persons. The D-FIS overall score was calculated as the sum of eight items, each scored on a 0 to 4 point scale, and ranges from 0 to 32. A higher score indicates a higher impact of fatigue on daily life. A negative change in D-FIS Overall Score means an improvement in HRQoL due to fatigue. Mean Baseline and mean change from Baseline to Week 12 are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||units on a scale||Standard Deviation|Mean
2601890|NCT02148718|Secondary|Inflammatory Bowel Disease Quality-36 (IBDQ-36) Questionnaire Overall Score: Change From Baseline to Week 12|The IBDQ-36 is used to assess the HRQoL related to bowel symptoms. The IBDQ-36 overall score is calculated as the sum of thirty-six items, each scored on a 1 to 7 likert point scale, and ranges from 7 to 252. The highest score indicates the best HRQoL related to bowel symptoms. A positive change in IBDQ-36 overall score indicates an improvement in HRQoL due to inflammatory bowel disease. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L VAS are presented.|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||units on a scale||Standard Deviation|Mean
2601891|NCT02148718|Secondary|European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Visual Analog Scale (VAS): Change From Baseline to Week 12|"The EQ-5D-3L is a standardized instrument for use as a measure of HRQoL and consists of 2 components:~The EQ-5D-3L Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 3 levels of severity for each dimension ('no problems', 'some problems', and 'extreme problems'). The level of severity reported on each of the EQ-5D-3L dimensions determines a unique health state. Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0.~The EQ-5D VAS is a 20-cm scale with endpoints labeled best imaginable health and worst imaginable health anchored at 100 and 0, respectively.~A positive change represents an improvement in HRQoL. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L VAS are presented."|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||units on a scale||Standard Deviation|Mean
2601905|NCT02148445|Secondary|Carcinogen Exposure (Continued Smokers Only)|Creatinine-adjusted NNAL (4-(methylnitrosamino)-1-(3)pyridyl-1-butanol)) exposure over 12 months. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and NNAL. This analysis looks at NNAL among continuing smokers only.|Month 3, Month 6, Month 12|n=4 deceased participants were excluded from analysis, non-smokers at each time point excluded|||pg/mg creatinine||Standard Deviation|Geometric Mean
2603258|NCT02134119|Secondary|Hematological Measures - Erythropoietin|as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)||||mU/mL||Standard Deviation|Mean
2601892|NCT02148718|Secondary|European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Index Score: Change From Baseline to Week 12|"The EQ-5D-3L is a standardized instrument for use as a measure of health-related quality of life (HRQoL) and consists of 2 components:~The EQ-5D-3L Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 3 levels of severity for each dimension ('no problems', 'some problems', and 'extreme problems'). The level of severity reported on each of the EQ-5D-3L dimensions determines a unique health state. Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0.~The EQ-5D visual analog scale (VAS) is a 20-cm scale with endpoints labeled best imaginable health and worst imaginable health anchored at 100 and 0, respectively.~A positive change represents an improvement in HRQoL. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L Index Score are presented."|Baseline (Week 0) and Week 12|All participants in the ITT population with evaluable data|||units on a scale||Standard Deviation|Mean
2601893|NCT02148718|Secondary|Percentage of Participants With Clinical Remission at Weeks 2 and 4|Clinical remission defined as HBI < 5. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.|Weeks 2 and 4|ITT population|||percentage of participants||95% Confidence Interval|Number
2601894|NCT02148718|Secondary|Percentage of Participants With Clinical Response at Week 1|Clinical response defined as a decrease of at least 3 points in HBI score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.|Week 1|ITT population|||percentage of participants||95% Confidence Interval|Number
2601895|NCT02148718|Primary|Percentage of Participants With Clinical Response at Day 4|Clinical response defined as a decrease of at least 3 points in Harvey-Bradshaw Index (HBI) score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.|Day 4|Intent to Treat (ITT) population: all enrolled participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2601896|NCT02148588|Secondary|Reported Pain/Dysesthesia Descriptors on NPSI Questionnaire|"Composite scores on NPSI (Neuropathic Pain Symptom Inventory) questionnaire before and 40 minutes after the peripheral nerve block.~The NPSI assesses participant ranking of specific neuropathic pain descriptors, each ranked on a 0-10 scale, where 0 represents no burning/squeezing/electric shocks (etc), and 10 represents worst burning/squeezing/electric shocks (etc).~The scores on individual questions are grouped (averaged) into the three following subscales (each subscale scores ranging from 0 to 10):~Burning pain~Paroxysmal pain~Paresthesia/dysesthesia"|baseline and 40 min||||units on a scale||Standard Deviation|Mean
2601897|NCT02148588|Secondary|Change in the Intensity of Brush Sensation|"The intensity of brush sensation (application of SENSELab Brush-05) was measured on 0-10 scale, where 5 represents normal sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful brushing sensation); lower scores represent reduced sensitivity (0=no brushing sensation)"|baseline and 30 min|The entire cohort|||units on a scale||Standard Deviation|Mean
2601898|NCT02148588|Secondary|Change in the Intensity of Pinprick Sensation|"The intensity of pinprick sensation (application of Semmes-Weinstein monofilament #6.1, ~100g target force) was measured on 0-10 scale, where 5 represents normal sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful sharp); lower scores represent reduced sensitivity (0=no pricking sensation)"|baseline and 30 min|The entire cohort|||units on a scale||Standard Deviation|Mean
2601899|NCT02148588|Secondary|Change in the Intensity of Warm Sensation|"The intensity of warm sensation (application of roller heated up to 40 degrees Celsius) was measured on 0-10 scale, where 5 represents normal sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful hot); lower scores represent reduced sensitivity (0=no warmth sensation)"|baseline and 30 min|The entire cohort|||units on a scale||Standard Deviation|Mean
2601900|NCT02148588|Secondary|Change in the Intensity of Cold Sensation|"The intensity of cold sensation (application of roller cooled down to 20 degrees Celsius) was measured on 0-10 scale, where 5 represents normal sensation (comparable to contralateral non-painful extremity). Higher scores indicate increased sensitivity (10= painful cold); lower scores represent reduced sensitivity (0=no cold sensation)"|baseline and 30 min|The entire cohort|||units on a scale||Inter-Quartile Range|Median
2601901|NCT02148588|Primary|Reduction in Spontaneous Pain Intensity After a Peripheral Nerve Block.|"Reduction in spontaneous pain intensity in the painful extremity from baseline to 30 minutes after a peripheral nerve block.Spontaneous pain intensity was measured on 0-10 numerical rating scale (NRS), where 0 represents no pain, and 10 represents worst pain imaginable"|baseline and 30 minutes|ITT|||units on a scale||Inter-Quartile Range|Median
2601902|NCT02148523|Secondary|Morisky Medication Adherence Scale (MMAS)|"The secondary outcome will be subjects' self-reports medication adherence. Morisky et al. developed this 8-item MMAS (MMAS-8) in 2008. The first seven items are Yes/No responses while the last item is a 5-point Likert response. The scoring scheme is: Yes = 0 and No = 1 (and 0 = 0 and 1-4 = 1 for Likert question). The items are summed to give a range of scores from 0 to 8. Respondents' summed score get grouped as follows: 0 = High Adherence; 1-2 = Medium Adherence; 3-8 = Low Adherence."|90 days||||units on a scale||Inter-Quartile Range|Median
2601903|NCT02148523|Primary|Statin Adherence|The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps.|90 days||||percentage of correct statin doses||Standard Deviation|Mean
2601928|NCT02148250|Primary|Duration (in Hours) of 20 % Dextrose Infusion Requirement||24 hours post insulin injection||||hours||Standard Deviation|Mean
2603259|NCT02134119|Secondary|Hematological Measures - Erythropoietin|as measured by erythropoietin (EPO) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)||||mU/mL||Standard Deviation|Mean
2601906|NCT02148445|Secondary|Carbon Monoxide Exposure (Continued Smokers Only)|Carbon monoxide (CO) exposure over 12 months. At Month 3, Month 6, and Month 12, participants completed an expired carbon monoxide laboratory test, which measured CO in parts per million. This analysis looks at CO among those continuing to smoke.|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis, non-smokers at each time point excluded|||parts per million (ppm)||Standard Deviation|Mean
2601907|NCT02148445|Secondary|Average Cigarettes Per Day (Continued Smokers Only)|"Average number of cigarettes per day over one year, among continued smokers. All participants were asked During the past 7 days, on those days that you smoked, what was the average number of cigarettes smoked per day? at Month 3, Month 6, and Month 12. This analysis looks at the number of cigarettes per day among participants who were still smoking."|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis, non-smokers at each time point excluded|||cigarettes per day||Standard Deviation|Mean
2601908|NCT02148445|Secondary|Cotinine|Cotinine over 12 months, adjusted for creatinine. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and cotinine.|Month 3, Month 6, Month 12|n=4 deceased participants were excluded from analysis|||ng/mg creatinine||Standard Deviation|Geometric Mean
2601909|NCT02148445|Secondary|7-day Abstinence|"Self-reported and biochemically verified 7-day abstinence. Participants were asked at Month 3, Month 6, and Month 12, Have you smoked any cigarettes or little cigars, even a puff, in the past 7 days? They also completed an exhaled carbon monoxide lab test at Month 3, 6 and 12. Biochemical verification= exhaled CO <=10 ppm. Month 12 biochemically verified abstinence is the primary outcome, and is not reported in this table."|Month 3, Month 6, Month 12|n=4 deceased participants were excluded from analysis. Missing responses were coded as smokers.|||Participants|||Count of Participants
2601910|NCT02148445|Secondary|Cardiac-related Hospital Visits|Number of cardiac-related hospital admissions and emergency room visits. Participants were asked how many times they had visited the ED or were admitted to the hospital for cardiac-related problems at Month 3, Month 6, and Month 12.|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis|||Participants|||Count of Participants
2601911|NCT02148445|Secondary|Respiratory-related Hospital Visits|Number of respiratory-related hospital admissions and emergency room visits. Participants were asked how many times they had visited the ED or were admitted to the hospital for respiratory-related problems at Month 3, Month 6, and Month 12|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis|||Participants|||Count of Participants
2601912|NCT02148445|Secondary|Respiratory Symptoms|Respiratory symptoms as measured by the COPD Assessment Test (CAT) respiratory questionnaire. Participants completed this 8-item assessment at Month 3, Month 6, and Month 12. Scores range from 0 to 40, with higher levels indicating higher impact of COPD on well-being and daily life.|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis|||units on a scale||Standard Deviation|Mean
2601913|NCT02148445|Secondary|Respiratory Function|Change in respiratory function, as measured by spirometry (FEV1), at 12 months post-randomization.|Month 12|n=4 deceased participants excluded from analysis. Participants with missing data excluded.|||% of predicted||Standard Deviation|Mean
2601914|NCT02148445|Secondary|Carcinogen Exposure|Creatinine-adjusted NNAL (4-(methylnitrosamino)-1-(3)pyridyl-1-butanol)) exposure over 12 months. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and NNAL.|Month 3, Month 6, Month 12|n=4 deceased participants were excluded from analysis.|||pg/mg creatinine||Standard Deviation|Geometric Mean
2601915|NCT02148445|Secondary|Carbon Monoxide Exposure|Carbon monoxide (CO) exposure over 12 months. At Month 3, Month 6, and Month 12, participants completed an expired carbon monoxide laboratory test, which measured CO in parts per million.|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis|||parts per million (ppm)||Standard Deviation|Mean
2601916|NCT02148445|Secondary|Average Cigarettes Per Day|"Average number of cigarettes per day over one year. Participants were asked at Month 3, Month 6, and Month 12 During the past 7 days, on those days that you smoked, what was the average number of cigarettes or little cigars smoked per day?"|Month 3, Month 6, Month 12|n=4 deceased participants excluded from analysis|||cigarettes per day||Standard Deviation|Mean
2601917|NCT02148445|Secondary|Quit Attempts|Number of self-reported quit attempts over one year. At Month 3 and Month 6, participants reported the number of quit attempts in the last 3 months. At Month 12, participants reported the number of quit attempts in the last 6 months.|Month 3, Month 6, Month 12|n=4 deceased participants were excluded from analysis.|||number of quit attempts||Standard Deviation|Mean
2601918|NCT02148445|Secondary|Sustained Abstinence|"6 month sustained abstinence as measured by self-report at 6 and 12 months and confirmed by CO at 6 and 12 months. Participants who were confirmed as non-smokers by carbon monoxide (CO) at both Month 6 and Month 12 were considered to have 6-month sustained abstinence."|Month 6 through Month 12|n=4 deceased participants were excluded from analysis. Missing values were counted as smokers.|||Participants|||Count of Participants
2601919|NCT02148445|Primary|Smoking Abstinence (Point Prevalent)|7-day point prevalent abstinence at 12 months, confirmed by exhaled CO <=10|Month 12|n=4 deceased participants were excluded from analysis. Missing values were counted as smokers.|||Participants|||Count of Participants
2601920|NCT02148302|Secondary|Incidence of Adverse Event|Incidence of adverse events with epidermal grafting versus standard of care.|12 weeks||||percentage of participants|||Number
2601921|NCT02148302|Secondary|Wound Area Change at Week 12|Percentage of wound area change at Week 12|12 weeks||||percentage of area change||Standard Deviation|Mean
2601922|NCT02148302|Secondary|Wound Area Change at Week 4|Percentage of wound area change at week 4|4 weeks||||percentage of area change||Standard Deviation|Mean
2601923|NCT02148302|Primary|Number of Patients With Healed Wounds|Number of patients experiencing wound healing with epidermal grafting and standard of care vs. standard of care alone|12 weeks||||participants|||Number
2601924|NCT02148250|Secondary|Total Glucose Required to Maintain Euglycaemia||24 hours||||mg/kg||Standard Deviation|Mean
2601925|NCT02148250|Secondary|Time Following Injection the Glucose Infusion Was Started to Maintain EU||24 hours||||hours||Standard Deviation|Mean
2601926|NCT02148250|Secondary|Total Glucose Given After U-500 Dose||4 hours||||mg/kg||Standard Deviation|Mean
2601927|NCT02148250|Secondary|Peak Infusion Rate Achieved After U-500||4 hours after insulin injection||||mg/kg/min||Standard Deviation|Mean
2601929|NCT02148133|Secondary|Mean Change in Eltrombopag Concentration in Pharmacokinetic Serum Samples Over Time at Days 14 and 15|At every study center, blood samples was be collected on Day 15 of multiple doses of eltrombopag 25 mg to determine the plasma eltrombopag concentration prior to the next dose (trough concentration). In addition, one-point pre-dose blood sampling was performed at every study center on Day 15 of multiple doses of eltrombopag 50 mg, 75 mg and 100 mg to determine trough concentrations. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Day 14 (pre-dose, 1, 2, 4, 6, 8 and 24 post-dose), Day 15 (pre-dose)|Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least one valid PK concentration value, was considered.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2601930|NCT02148133|Secondary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Subject Across All Treatments (AUC 0-t) and Over the Dosing Interval (AUC 0-tau) for Eltrombopag|At some study sites, full blood sampling for pharmacokinetic (PK) evaluation of Eltrombopag was performed on Day 14 to calculate Cmax, tmax, AUC(0-t), and AUC(0-tau). PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Day 14 at 25 mg QD (-0.05, 0.15, 0.30, 0.45, 1.00, 1.30 and 24.00), at 50,75 and 100 mg QD (pre-dose)|Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least one valid PK concentration value, was considered.|||Hours*nanograms/milliliter (hr*ng/mL)||Standard Deviation|Mean
2601931|NCT02148133|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) for Eltrombopag|At some study sites, full blood sampling for pharmacokinetic (PK) evaluation of Eltrombopag was performed on Day 14 to calculate Cmax, tmax, AUC(0-t), and AUC(0-tau). PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Day 14 at 25 mg QD (-0.05, 0.15, 0.30, 0.45, 1.00, 1.30 and 24.00), at 50,75 and 100 mg QD (pre-dose)|Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least one valid PK concentration value, was considered.|||Hour||Full Range|Median
2601932|NCT02148133|Secondary|Maximum Observed Plasma Concentration (Cmax) for Eltrombopag|At some study sites, full blood sampling for pharmacokinetic (PK) evaluation of Eltrombopag was performed on Day 14 to calculate Cmax, tmax, AUC(0-t), and AUC(0-tau). PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Day 14 at 25 mg QD (-0.05, 0.15, 0.30, 0.45, 1.00, 1.30 and 24.00), at 50,75 and 100 mg QD (pre-dose)|Pharmacokinetic Analysis Set (PAS), which consisted of all participants with at least one valid PK concentration value, was considered.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2601933|NCT02148133|Secondary|Number of Participants With Bleeding Events and Severity of Bleeding|The measurements were followed up to Week 26 and thereafter in the extension part.|Up to 30 days after last dose of study treatment|Safety Analysis Set, all subjects who took at least one dose of study treatment. A subject with multiple adverse events within a primary system organ class was counted only once in the total row. Only descriptive analysis done.|||N° of Participants with Bleeding events|||Number
2601934|NCT02148133|Secondary|Long-term Safety and Tolerability of Eltrombopag|The frequency and percentage of subjects who experienced adverse events (AEs), serious adverse events (SAEs) and deaths by primary system organ class (SOC) and MedDRA preferred term were summarized.|Up to 30 days after last dose of study treatment|Safety Analysis Set, all subjects who took at least one dose of study treatment. A subject with multiple adverse events within a primary system organ class was counted only once in the total row. Only descriptive analysis done.|||Percentage of participants|||Number
2601935|NCT02148133|Secondary|Percentage of Participants Who Become Transfusion (Platelet and RBC) Independent|The proportion of participants for whom blood transfusion (platelets and RBC) became unnecessary was measured and reported as a percentage. The measurements were followed up to Week 26 and thereafter in the extension part (Up to the launch of the product after approval, which will be approximately up to two and a half years). Only descriptive analysis done. This analysis was performed for the subjects who were baseline transfusion dependent.|Up to 2.5 years|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Percentage of participants|||Number
2601936|NCT02148133|Secondary|Percentage of Participants With Reduced Volume of Transfusion (Platelet and RBC)|The proportion of the participants for whom the amount of blood transfusion (platelets and RBC) is decreased was measured and reported as a percentage. The measurements were followed up to Week 26 and thereafter in the extension part (Up to the launch of the product after approval, which will be approximately up to two and a half years). Only descriptive analysis done. This analysis was performed for the subjects who were baseline transfusion dependent.|Up to 2.5 years|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Percentage of participants|||Number
2601937|NCT02148133|Secondary|Frequency of (Platelet and RBC) Transfusion in Each Period|The frequency of blood transfusion (platelets, RBC) were summarized. The measurements were followed up to Week 26 and thereafter in the extension part (Up to the launch of the product after approval, which will be approximately up to two and a half years). Only descriptive analysis done.|Day 1, Day 92 (Week 13), Day 183 (Week 26), Extension W39 and Extension W52|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Tansfusion||Standard Deviation|Mean
2601938|NCT02148133|Secondary|Volume of (Platelet and RBC) Transfusion in Each Period|The amount of blood transfusion (platelets, RBC) were summarized. The measurements were followed up to Week 26 and thereafter in the extension part (Up to the launch of the product after approval, which will be approximately up to two and a half years). Only descriptive analysis done.|Day 1, Day 92 (Week 13), Day 183 (Week 26), Extension W39 and Extension W52|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||milliliter (mL)||Standard Deviation|Mean
2601939|NCT02148133|Secondary|Duration of Hematological Response in Participants Who Responded at the Week 13|The duration of haematological response was defined, for subjects who responded at the Week 13 visit, as the number of months from the first date of a response until the first date of a relapse or the date the subject was last assessed. Only subjects with at least 2 response assessments were included in the duration of response assessment. The measurements were followed up to Week 26 and thereafter in the extension part (Up to the launch of the product after approval, which will be approximately up to two and a half years). Only descriptive analysis done.|Up to 2.5 years|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Months||Inter-Quartile Range|Median
2601940|NCT02148133|Secondary|Hematological Response at Week 13 in Terms of the Platelet Count, Hemoglobin Level and Neutrophil Count|The frequency and percentage were calculated with 95% confidence interval (CI) of responses (which meet each response criteria) of platelet count, hemoglobin and neutrophil count at Week 13.|Week 13|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Percentage of participants||95% Confidence Interval|Number
2601941|NCT02148133|Secondary|Change in Neutrophil Count From Baseline in the Absence of Granulocyte-colony Stimulating Factor (G-CSF) Over Time|The changes in observed values for Neutrophil Count were summarized. The measurements were followed up to Week 26 and thereafter in the extension part (Up to the launch of the product after approval, which will be approximately up to two and a half years). Only descriptive analysis done.|Up to 2.5 years|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Giga/Liter (Gi/L)||Standard Deviation|Mean
2601942|NCT02148133|Secondary|Change in Hemoglobin From Baseline in the Absence of Red Blood Cell (RBC) Transfusion Over Time|The changes in observed values for Hemoglobin were summarized. The measurements were followed up to Week 26 and thereafter in the extension part (Up to the launch of the product after approval, which will be approximately up to two and a half years). Only descriptive analysis done.|Up to 2.5 years|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Gram/Liter (g/L)||Standard Deviation|Mean
2601943|NCT02148133|Secondary|Change in Platelet Count From Baseline in the Absence of Platelet Transfusion Over Time|The changes in observed values for Platelet Count were summarized. The measurements were followed up to Week 26 and thereafter in the extension part (Up to the launch of the product after approval, which will be approximately up to two and a half years). Only descriptive analysis done.|Up to 2.5 years|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Giga/Liter (Gi/L)||Standard Deviation|Mean
2601944|NCT02148133|Primary|Hematological Response at Week 26|Hematologic response rate at 6 months (at WeeK 26) after the start of study treatment was defined as the percentage of subjects who met any of the response criteria (Platelet count, Hemoglobin level, Neutrophil count). 1 ) Platelet count: an increase from baseline by 20,000/μL or more (In the absence of platelet transfusion), or no platelet transfusion requirements for 8 weeks; 2) Hemoglobin: When the baseline hemoglobin level is <9 g/dL: Without RBC transfusion at baseline, an increase from baseline by 1.5 g/dL or more; With RBC transfusion at baseline, a decrease of at least 4 units in RBC transfusions in the post-treatment 8-week period compared to the pre-treatment 8-week period (1 unit = RBC derived from 200 mL blood); 3) Neutrophil count: an increase from baseline by 500/μL or more (in the absence of granulocyte colony-stimulating factor (G-CSF)), or (if < 500/μL at baseline) an increase by 100 % or more. Only descriptive analysis done.|D183 (Week 26)|The Full Analysis Set (FAS), which consisted of all participants with an observed value, was considered.|||Percentage of participants||95% Confidence Interval|Number
2601945|NCT02148107|Secondary|Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)|"Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t).~This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study."|312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration|PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.||||||
2601946|NCT02148107|Secondary|AUCt,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)|"AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t).~This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study."|312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration|PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.||||||
2601947|NCT02148107|Secondary|Cmax (Maximum Measured Concentration of the Analyte Inplasma)|"Cmax (maximum measured concentration of the analyte inplasma).~This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study."|0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration|PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.||||||
2601948|NCT02148107|Secondary|AUCt,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval t After Administration of the First Dose)|"AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose).~This endpoint could not be calculated as no PK blood samples were analysed due to the early termination of the study."|0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration|PK set. As no PK blood samples were analysed due to the early termination of the study, no PK parameters could be calculated and so the PK set contains 0 participants.||||||
2601949|NCT02148107|Primary|Percentage of Subjects With Drug-related Adverse Events|Percentage of subjects with drug-related Adverse events (AEs)|From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days|Treated set|||Percentage of participants|||Number
2601950|NCT02147899|Secondary|Number of Patients With a Normal Nugent Score|The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid.|Study Days 21-30|mITT|||Participants|||Count of Participants
2601951|NCT02147899|Secondary|Number of Patients With Therapeutic Cure|Clinical Cure and Normalization of the Nugent score. The Nugent score is based on a microscopic assessment of a Gram stain of the vaginal fluid.|Study Days 21-30|||||||
2601952|NCT02147899|Secondary|Cure of Bacterial Vaginosis|Number of subjects with therapeutic cure at TOC/EOS (clinical cure + normalization of Nugent score)|Study Days 21-30|||||||
2601980|NCT02147613|Secondary|VO2peak|Measured using a graded exercise test (modified Bruce protocol) with 12-lead EKG monitoring and ventilatory gas exchange analysis.|Test carried out before and after the 1 month long exercise intervention.||||ml/kg/min||Standard Deviation|Mean
2601953|NCT02147899|Primary|Cure of Bacterial Vaginosis|"Clinical Cure is a composite endpoint determined by normalization of the vaginal discharge and a negative KOH Whiff test and Clue cells less than 20% of the total epithelial cells on microscopic examination of the vaginal wet mount. (Number of subjects with clinical cure at TOC/EOS)"|Study Days 21-30|mITT|||Participants|||Count of Participants
2601954|NCT02147834|Secondary|Ischemia Driven Revascularization or Hospitalization|frequency of the number of reported adverse events for ischemia driven revascularization or hospitalization|4 month|The investigator ended this study early due to futility. No data was analyzed.||||||
2601955|NCT02147834|Secondary|Subjective Well Being|overall feeling of well being determined from rating of excellent, good, fair or poor at baseline compared to same at month 4|Compare from baseline to month 4|The investigator ended this study early due to futility. no data was analyzed.||||||
2601956|NCT02147834|Primary|Seattle Angina Questionnaire Score Change From Baseline to Month 4|The Seattle Angina Questionnaire is a valid and reliable instrument that measures five clinically important dimensions of health in patients with coronary artery disease (physical limitation, anginal stability, anginal frequency, treatment satisfaction, and disease perception).|Change in baseline to month 4|The investigator ended this project early due to futility. Do data was analyzed.||||||
2601957|NCT02147769|Primary|Severe Central Nervous System (CNS) Morbidity|Routine cranial ultrasound obtained within the first ten days of life will be utilized to detect grade 3 or 4 intraventricular hemorrhage, periventricular leukomalacia, significant ventriculomegaly, or white matter abnormalities.|Outcome measure will be assessed on day 10 of life. Participants will be followed for neuroradiographic evidence of CNS morbidity in the first ten days of life||||Participants|||Count of Participants
2601958|NCT02147769|Primary|Mortality Before Hospital Discharge|Participants will be followed for the outcome of death prior to hospital discharge.|Outcome measure will be assessed at the time of subject's initial discharge from the hospital (on average by 40 weeks postmenstrual age), but at a maximum of 1 year of life.||||Participants|||Count of Participants
2601959|NCT02147691|Secondary|DLQI|Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)|Week 12||||units on a scale||Standard Deviation|Mean
2601960|NCT02147691|Secondary|DLQI|Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)|Week 8||||units on a scale||Standard Deviation|Mean
2601961|NCT02147691|Secondary|Dermatology Life Quality Index (DLQI)|Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)|Week 4||||units on a scale||Standard Deviation|Mean
2601962|NCT02147691|Secondary|VAS|participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable|Week 12||||units on a scale||Standard Deviation|Mean
2601963|NCT02147691|Secondary|VAS|participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable|Week 8||||units on a scale||Standard Deviation|Mean
2601964|NCT02147691|Secondary|Visual Analog Scale (VAS)|participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable|Week 4||||units on a scale||Standard Deviation|Mean
2601965|NCT02147691|Secondary|Erythema|Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red|Week 12||||units on a scale||Standard Deviation|Mean
2601966|NCT02147691|Secondary|Erythema|Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red|Week 8||||units on a scale||Standard Deviation|Mean
2601967|NCT02147691|Secondary|Erythema|Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red|Week 4||||units on a scale||Standard Deviation|Mean
2601968|NCT02147691|Secondary|Lesion Counts||Week 12||||lesions||Standard Deviation|Mean
2601969|NCT02147691|Secondary|Lesion Counts||Week 8||||lesions||Standard Deviation|Mean
2601970|NCT02147691|Secondary|Lesion Count||Week 4||||lesions||Standard Deviation|Mean
2601971|NCT02147691|Primary|IGA|Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe|Week 12||||units on a scale||Standard Deviation|Mean
2601972|NCT02147691|Primary|IGA|Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe|Week 8||||units on a scale||Standard Deviation|Mean
2601973|NCT02147691|Primary|IGA|Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe|Week 4||||units on a scale||Standard Deviation|Mean
2601974|NCT02147691|Secondary|Dermatology Life Quality Index (DLQI)|The DLQI is a self-administered questionnaire consisting of 10 questions that measure how much the individual's skin problem has affected their life in the past week. Score ranges 0 through 30, 0 being none and 30 worst possible.|Baseline||||units on a scale||Standard Deviation|Mean
2601975|NCT02147691|Secondary|Erythema Visual Analog Scale (VAS) Assessment (Subject)|Subjects will self assess the level of erythema over the previous 24 period using a scale of None (0) through 10 (Unbearable)|Baseline||||units on a scale||Standard Deviation|Mean
2601976|NCT02147691|Secondary|Clinician's Erythema Assessment|Erythema will be graded on a scale of 0-4., 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 very severe. If erythema is much worse on one or several parts of the face, the grade for the worst area will be captured.|Baseline||||units on a scale||Standard Deviation|Mean
2601977|NCT02147691|Secondary|Lesion Counts|The number of inflammatory lesions (papules/pustules) will be counted using the whole face from the hairline edge to the mandibular line|Baseline||||lesions||Standard Deviation|Mean
2601978|NCT02147691|Primary|Investigator Global Assessment (IGA) at Baseline|Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe|Baseline|Only participants who were not lost to follow up or did not withdraw consent were included in the final analysis.|||units on a scale||Standard Deviation|Mean
2601979|NCT02147613|Other Pre-specified|Brachial Artery Flow-mediated Dilation|Reactive hyperemia mediated brachial artery dilation will be measured after 5 minutes of ischemia with forearm cuff occlusion. Artery will be continuously monitored using B-mode ultrasound.|Before and after 1-month exercise intervention||||percentage of FMD||Standard Deviation|Mean
2601981|NCT02147613|Primary|Left Ventricular Diastolic Dysfunction|Measured using left ventricular echocardiography. Diastolic dysfunction is graded as: normal, grade 1, grade 2, grade 3, grade 4. Increasing grade is indicative of worsening LV dysfunction and worse outcomes. Improvement in LV grade is associated with better long term outcomes.|Before and after the 1 month exercise intervention||||DD grade||Standard Deviation|Mean
2601982|NCT02147587|Other Pre-specified|Number of Participants With Clinically Significant Abnormal Laboratory Parameters|Participants with the following abnormalities were discontinued from the study: 2 sequential absolute neutrophil counts (ANC) <1000/mm^3; 2 sequential hemoglobin values <8.0 g/dL or decreases of >30% from baseline value; 2 sequential absolute lymphocyte count <500/mm^3; 2 sequential platelet counts <75,000/mm^3; 2 sequential alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations >=3 times the upper limit of normal (X ULN) with a total bilirubin value >=2X ULN, elevated international normalized ratio (INR), or accompanied by signs/symptoms consistent with hepatic injury; 2 sequential ALT or AST elevations >=5X ULN regardless of total bilirubin or accompanying symptoms; confirmed increases in serum creatinine (SCr) >50% over the average of screening and baseline values; a confirmed positive urine pregnancy test or refusal to use appropriate contraception in a woman of childbearing potential.|Baseline up to Week 16|The safety analysis population included randomized participants who received at least 1 dose of the study drug (tofacitinib or placebo).|||participants|||Number
2601983|NCT02147587|Other Pre-specified|Number of Participants With Clinical Herpes Zoster Events by Severity|Clinical herpes is manifested as mild, moderate, or severe disseminated herpes zoster.|Baseline up to Week 16|The safety analysis population included randomized participants who received at least 1 dose of the study drug (tofacitinib or placebo).|||participants|||Number
2601984|NCT02147587|Other Pre-specified|Number of Participants With Zoster Vaccine-Related AEs by System Organ Class|Zoster vaccine-related AEs included General Disorders and Administration Site Conditions (injection site erythema, pain, pruritis, rash, swelling; vaccination site erythema, pruritus, rash), Infections and Infestations (disseminated herpes zoster), and Musculoskeletal and Connective Tissue Disorders (myalgia). All zoster vaccine-related AEs were mild, except for the herpes zoster AE classified under Infections and Infestations, which was moderate in severity.|Baseline up to Week 16|The safety analysis population included randomized participants who received at least 1 dose of the study drug (tofacitinib or placebo).|||participants|||Number
2601985|NCT02147587|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 16 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to Week 16|The safety analysis population included randomized participants who received at least 1 dose of the study drug (tofacitinib or placebo).|||participants|||Number
2601986|NCT02147587|Secondary|Percentage of Participants With >=1.5 Fold Change in VZV-Specific IgG Levels Day 1, Week 4 and Week 12|VZV-specific IgG levels as measured by ELISA. A ratio greater than or equal to (>=)1.5 was defined as a responder.|Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination)|The evaluable immunogenicity analysis population included randomized participants who had at least 1 dose of study drug (tofacitinib or placebo) and who complied closely with protocol eligibility criteria, visit windows for study procedures, had valid assay results at the primary visits and no major protocol deviations.|||percentage of participants||80% Confidence Interval|Number
2601987|NCT02147587|Secondary|Absolute Values in VZV-Specific IgG Levels at Day 1, Week 4 and Week 12|The absolute geometric mean titer (GMT) of VZV-specific IgG levels was calculated from logarithmically transformed assay values.|Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination)|The evaluable immunogenicity analysis population included randomized participants who had at least 1 dose of study drug (tofacitinib or placebo) and who complied closely with protocol eligibility criteria, visit windows for study procedures, had valid assay results at the primary visits and no major protocol deviations.|||[gp]ELISA units/mL||80% Confidence Interval|Geometric Mean
2601988|NCT02147587|Secondary|Fold Change From Baseline in VZV-Specific IgG Levels at Day 1 and Week 12||Baseline (pre-vaccination; Day -14), Day 1 (2 weeks post-vaccination), Week 12 (14 weeks post-vaccination)|The evaluable immunogenicity analysis population included randomized participants who had at least 1 dose of study drug (tofacitinib or placebo) and who complied closely with protocol eligibility criteria, visit windows for study procedures, had valid assay results at the primary visits and no major protocol deviations.|||fold rise||80% Confidence Interval|Geometric Mean
2601989|NCT02147587|Primary|Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4|VZV-specific IgG levels as measured by enzyme-linked immunosorbent assay (ELISA).|Baseline (pre-vaccination; Day -14), Week 4 (6 weeks post-vaccination)|The evaluable immunogenicity analysis population included randomized participants who had at least 1 dose of study drug (tofacitinib or placebo) and who complied closely with protocol eligibility criteria, visit windows for study procedures, had valid assay results at the primary visits and no major protocol deviations.|||fold rise||80% Confidence Interval|Geometric Mean
2601990|NCT02147561|Secondary|Physician Global Assessment of Outcome on a 3-Point Scale|Physicians evaluated patient migraines as improved, no change, or worse compared to baseline.|Baseline, Day 28|Efficacy Population: patients enrolled in the study, who received study drug, and who had an efficacy assessment|||Patients|||Number
2601991|NCT02147561|Secondary|Change From Baseline in Headache Impact Test-6 (HIT-6) Total Score|The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.|Baseline, Day 28|Efficacy Population: patients enrolled in the study, who received study drug, and who had an efficacy assessment|||Scores on a Scale||Standard Deviation|Mean
2601992|NCT02147561|Primary|Percentage of Patients With Adverse Events|An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|28 Days|Safety Population: patients enrolled in the study who received study drug|||Percentage of Patients|||Number
2601993|NCT02147522|Other Pre-specified|Change From Baseline in Self-Efficacy for Managing Chronic Disease (SEMCD) Score|The Self-Efficacy for Managing Chronic Disease (SEMCD) contains 6 items that are common across chronic diseases: symptom control, role function, emotional functioning and communicating with physicians, rated in a scale 1 (not at all confident) to 10 (totally confident). The score for the scale is the mean of the six items. Higher number indicates higher self-efficacy.|baseline, 6- and 12-month follow-ups|Some participants did not complete follow-up assessments (6-month: 48 AHH and 37 UC; 12-month: 56 AHH and 48 UC).|||units on a scale||Standard Deviation|Mean
2601994|NCT02147522|Secondary|Change From Baseline in MOS Short-Form Health Survey Physical Component Summary (PCS)|The Physical Component Summary (PCS) is a norm-based score standardized to the general U.S. population with a mean of 50, and a SD of 10. Scores range from 0 to 100, a higher score indicating better physical health.|baseline, 6- and 12-month follow-ups|Some participants did not complete follow-up assessments (6-month: 48 AHH and 37 UC; 12-month: 56 AHH and 48 UC).|||units on a scale||Standard Deviation|Mean
2601995|NCT02147522|Primary|Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline|"The PHQ-9, which establishes provisional depressive disorder diagnosis as well as grades depressive symptom severity, will be obtained from all study subjects at recruitment and during the four waves of data collection (up to 12 months). The PHQ-9 scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day), with possible scores ranging from 0 to 27, with cut points of 5,10,15, and 20 representing the thresholds for mild, moderate, moderately severe, and severe depression. A validated Spanish version of the PHQ-9 will be used. Clinically meaningful improvement of depressive symptoms was assessed as a ≥50% score reduction since baseline assessment."|6- and12-month follow-ups|Analyses for hypothesis testing related to the evaluation of AHH effects were carried out according to the intention-to-treat rule consistent with standard practice in clinical trials.|||Participants|||Count of Participants
2601996|NCT02147353|Secondary|Mean Change in Number of Lesions|Mean change in number of lesions as compared to baseline at Week 1, Week 9 and Week 17 for the intent-to-treat population|At week 1, week 9, and week 17||||lesions||Standard Deviation|Mean
2601997|NCT02147353|Secondary|Mean Change in Number of Lesions|Mean change in number of lesions after 1 weeks, 9 weeks and 17 weeks post treatment as compared to baseline|Week 1, week 9 and week 17|data for only those participants who returned for the respective visits.|||number of lesions||Standard Deviation|Mean
2601998|NCT02147353|Secondary|Subjects With Partial Clearance of Lesions|Partial clearance is described as at least 50% reduction from baseline|At week 1, week 9, and week 17||||participants|||Number
2601999|NCT02147353|Secondary|Local Skin Reactions|"To evaluate the safety of cryotherapy-sinecatechins 15% ointment BID versus cryotherapy alone as a regimen for EGW by evaluating for local skin reactions and adverse events.~Number of participants with local skin reactions."|at 16 week treatment period||||Participants|||Count of Participants
2602000|NCT02147353|Secondary|Number of Participants With Recurrence of Previously Treated EGW Lesions|To evaluate the efficacy of using combination cryotherapy-sinecatechins 15% ointment BID versus cryotherapy alone on EGW lesions via recurrence rates of previously treated EGW lesions in those subjects who achieved a complete response over a 48 week post-treatment period.|at 48 week post-treatment period||||Participants|||Count of Participants
2602001|NCT02147353|Secondary|Number of Participants With Recurrence of Previously Treated EGW Lesions|To evaluate the efficacy of using combination cryotherapy-sinecatechins 15% ointment BID versus cryotherapy alone on EGW lesions via recurrence rates of previously treated EGW lesions in those subjects who achieved a complete response over a 24 week post-treatment period.|at 24 week post-treatment period||||Participants|||Count of Participants
2602002|NCT02147353|Primary|Number of Participants With Complete Clearance,|Subjects with complete clearance, or no longer have HPV infected cells. Complete clearance was defined as zero lesions at the respective time points.|at week 1, week 9, and week 17||||participants|||Number
2602003|NCT02147301|Secondary|Median Area Under Curve (AUC)|"Area under curve for doxorubicin concentration in the serum over 7 days was measured by obtaining serum doxorubicin concentration samples at predose, 5 min, 20 min, 40 min, 60 min, 120 min, 6 hours, 24 hours, 7 days time points. A graph of serum doxorubicin concentration over time was then plotted for each of the 17 patients, and the area under the curve for each of the 17 patients was calculated.~Pharmacokinetic sampling was performed only during each of the first planned DEB-TACE procedures."|7 days||||ng/ml-hr||Full Range|Median
2602004|NCT02147301|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left ventricular ejection fraction (LVEF) was measured as percent contraction prior to the first DEB-TACE and 1 month following last planned DEB-TACE. Median LVEF and full range were reported.|Baseline, 1 month following last planned DEB-TACE||||percent contraction||Full Range|Median
2602005|NCT02147301|Secondary|Proportion of Patients With Alpha-fetoprotein (AFP) Response With ≥ 50% Decline From Baseline|This measure was defined as the number of patients with alpha-fetoprotein (AFP) response with ≥ 50% decline from baseline (in patients with baseline level ≥ 20) after DEB-TACE.|1 year||||participants|||Number
2602006|NCT02147301|Secondary|Progression Free Survival (PFS) Rate|"Progression free survival rate was defined as the number of patients who were alive and free from radiographic progression by mRECIST at pre-defined time periods.~PFS rate was calculated at 3 months, 6 months, 12 months, and 24 months"|3 months, 6 months, 12 Months, and 24 months||||participants|||Number
2602007|NCT02147301|Secondary|Time to Hepatic Progression (TTHP)|Time to hepatic progression (TTHP) was defined as a period of time from the first on-study DEB-TACE till development of radiographic evidence of disease progression in the liver by mRECIST.|1 year||||Months||Full Range|Median
2602008|NCT02147301|Secondary|Time to Progression (TTP)|Time to progression was defined as the period of time from the first on-study DEB-TACE to radiographic disease progression at any site by mRECIST.|1 year||||Months||Full Range|Median
2602009|NCT02147301|Secondary|Time to Untreatable Progression (TTUP)|TTUP is defined as time (months) from the first on-study DEB-TACE to development of radiographic disease progression untreatable by liver-directed percutaneous or surgical methods (by mRECIST).|1 year|months|||Months||Full Range|Median
2602010|NCT02147301|Secondary|Best Observed Objective Radiographic Response by mRECIST|"Best observed objective radiographic response was defined as the number of patients who had a complete response or partial response divided by total number of evaluable patients.~Measured by mRECIST (see mRECIST definition in the description of the primary objective)."|6 months||||participants|||Number
2602012|NCT02147301|Primary|Best Observed Radiographic Response Rate (Measured by mRECIST)|Best observed radiographic response rate to Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE) by modified Response Evaluation Criteria in Solid Tumors (mRECIST) was defined as number of patients who had CR, PR, or SD as their best observed response divided by total number of patients with at least one available CT or MRI. Definition of mRECIST for Hepatocellular Carcinoma (HCC). Complete response (CR) = Disappearance of any intratumoral arterial enhancement in all target lesions. Partial response (PR)=At least a 30% decrease in sum of diameters of viable (enhancement in arterial phase) target lesions, taking as reference baseline sum of diameters of target lesions. Stable disease (SD)=Any cases that do not qualify for either partial response or progressive disease. Progressive disease (PD)=An increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enh|1 year|Best observed radiographic response for all patients who had at least one follow-up cross-sectional imaging study|||Participants|||Count of Participants
2602013|NCT02147288|Primary|Post-operative Seroma Formation|Quantitative assessment of fluid collection in pre-defined anatomic regions will be performed via ultrasound examination approximately two weeks following removal of drains (either JP or NPWT-associated)|Two weeks following drain removal|Among 21 completers (standard of care group); one outlier was excluded from the analysis; 20 subjects were analyzed. Among 22 completers (experimental group), one outlier and 1 who did not have an ultrasound (i.e., fluid was not measured) were excluded, leaving 20 subjects for analysis.|||cm^3||Full Range|Mean
2602014|NCT02147197|Secondary|Change From Baseline in Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) Revised Activities Subscale Score at the End of Treatment Period|The UFS-QOL is a uterine fibroid-specific questionnaire consisting of 37 questions developed to evaluate symptoms of uterine fibroids and their impact on health-related quality of life in women with leiomyomas. The first 8 questions comprise the Symptom Severity subscale to assess symptoms experienced by women with uterine leiomyomas, the remaining 29 questions comprise 6 subscales (Concern, Activities, Energy/mood, Control, Self-consciousness, Sexual Function) which overall deal with women's feelings and experiences regarding impact of uterine leiomyoma symptoms on her life. Each item is scored between 1 and 5, where 1=none of the time or not at all and 5=all of the time or a very great deal. A Revised Activities subscale was created to include the most relevant items pertaining to physical and social activities with a total possible score of 0 to 100. Higher Revised Activities subscale scores indicate less impact on activities. A positive change from Baseline indicates improvement.|Baseline (Day 1-4) to the end of 12-week Treatment Period|Data was summarized as per treatment assigned and included all participants with data at both Baseline and Week 12. The Baseline row shows the actual scores. The results at Week 12 are the difference in scores from Baseline to Week 12.|||score on a scale||Standard Deviation|Mean
2602015|NCT02147197|Secondary|Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment|Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e. no entries for bleeding or heavy bleeding; however, spotting was allowed), starting from Day 11 through the end of the 12-week Treatment Period.|Day 11 through the end of the 12-week Treatment Period|ITT Population included all randomized participants. Data was summarized as per the treatment assigned.|||percentage of participants||97.5% Confidence Interval|Number
2602016|NCT02147197|Primary|Time to Absence of Bleeding on Treatment|Time to absence of bleeding was defined as the duration in days from first dose to the first day in the time interval in which absence of bleeding occurs and persists through the last dose on treatment. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose on treatment in the 12-week Treatment Period.|From first dose up to the end of the 12-week Treatment Period|ITT Population included all randomized participants. Data was summarized as per the treatment assigned.|||days||97.5% Confidence Interval|Median
2602017|NCT02147197|Primary|Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment|Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e. no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in the 12-week Treatment Period.|Last 35 consecutive days on treatment in the 12-week Treatment Period|Intent-to-Treat (ITT) Population included all randomized participants. Data was summarized as per the treatment assigned.|||percentage of participants||97.5% Confidence Interval|Number
2602018|NCT02147184|Other Pre-specified|The Moderating Effect of the Short Allele of the Serotonin Transporter-Linked Polymorphic Region (5HTTLPR) Gene on the Association Between SSRI Use and the Primary Outcomes||2 years||2019-12-31|12/2019||||
2602019|NCT02147184|Secondary|Cortical Thickness at 20% Radius|This is cortical thickness as measured by pQCT.|At baseline and every 4 months up to 2 years.|The figures below may be lower than the overall numbers above due to exclusions for movement artifacts and premature drop outs.|||mm||Standard Deviation|Mean
2602020|NCT02147184|Secondary|Cortical Volumetric BMD at 20% Radius||At baseline and every 4 months up to 2 years.|This was the original sample size per group but the figures below reflect attrition and data exclusion due to movement artifacts.|||mg/cm^3||Standard Deviation|Mean
2602021|NCT02147184|Secondary|Lumbar Spine Bone Mineral Density (BMD) Z-score|This is a Z-score adjusted for sex, age, race, and height.|At baseline and every 8 months up to 2 years.|This was the initial sample size per group but the figures below reflect attrition or data excluded due to artifact.|||Z-score (Age-Sex-Height-Race Specific)||Standard Deviation|Mean
2602022|NCT02147184|Primary|Bone-specific Alkaline Phosphatase to C-terminal Telopeptide Ratio|Bone-specific alkaline phosphatase (ng/mL) is a marker of bone formation while C-terminal telopeptide (ng/mL) is a marker of bone resorption.|At baseline and every 4 months up to 2 years.|The figures below might be less than the stated numbers above depending on availability of serum samples, the performance of the assay, and premature attrition.|||Ratio||Standard Deviation|Mean
2602023|NCT02147184|Primary|Osteocalcin to C-terminal Telopeptide Ratio|Osteocalcin (ng/mL) is a bone formation marker and C-terminal telopeptide (ng/mL) a marker of bone resorption.|At baseline and every 4 months up to 2 years.|The figures below may be lower based on availability of serum, performance of the assay, and premature attrition.|||Ratio||Standard Deviation|Mean
2602718|NCT02139137|Secondary|Change in Functional Impairment; Sheehan Disability Scale|Range: 0-30; greater values indicate greater disability severity ratings|Baseline, Week 4|Data at one time point for one participant in the LIC condition are not available.|||units on a scale||Standard Deviation|Mean
2602024|NCT02147184|Primary|Trabecular Volumetric Bone Mineral Density at the Ultradistal Radius|Volumetric bone mineral density (vBMD) at the nondominant radius (4% and 20% sites) was measured, at study entry and every four months, with peripheral quantitative computed tomography (pQCT), using a Stratec XCT‐2000 scanner (Stratec, Inc., Pforzheim, Germany). Image analysis was performed using the manufacturer's software package, version 6.0. pQCT scans compromised by movement were rejected. Quality control and calibration of the equipment were performed daily.|At baseline and every 4 months up to 2 years.|This was the starting sample size. However, the figures below reflect participant attrition and exclusion of scans due to movement artifact.|||mg/cm^3||Standard Deviation|Mean
2602025|NCT02147184|Primary|Total Body Less Head Bone Mineral Content (TBLH BMC) Z-score (Adjusted for Age-sex-height-race)|Whole-body dual energy x-ray absorptiometry (DXA) scan was obtained using a Hologic QDR DELPHI-4500A unit or a Hologic Discovery A unit (Hologic, Inc, Bedford, MA). The two DXA units were cross-calibrated.|At baseline and every 8 months up to 2 years.|These are the starting sample size but the figures below reflect participant attrition.|||Z score (age-sex-height-race specific)||Standard Deviation|Mean
2602026|NCT02147158|Secondary|Change From Baseline in Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) Revised Activities Subscale Score at the End of Treatment Course 1|The UFS-QOL is a uterine fibroid-specific questionnaire consisting of 37 questions developed to evaluate symptoms of uterine fibroids and their impact on health-related quality of life in women with leiomyomas. The first 8 questions comprise the Symptom Severity subscale to assess symptoms experienced by women with uterine leiomyomas, the remaining 29 questions comprise 6 subscales (Concern, Activities, Energy/mood, Control, Self-consciousness, Sexual Function) which overall deal with women's feelings and experiences regarding impact of uterine leiomyoma symptoms on her life. Each item is scored between 1 and 5, where 1=none of the time or not at all and 5=all of the time or a very great deal. A Revised Activities subscale was created to include the most relevant items pertaining to physical and social activities with a total possible score of 0 to 100. Higher Revised Activities subscale scores indicate less impact on activities. A positive change from Baseline indicates improvement.|Baseline (Day 1-4) to End of 12-Week Treatment Course 1|Data was summarized as per treatment assigned and included all participants with data at both Baseline and Week 12 in Treatment Course 1.|||score on a scale||Standard Deviation|Mean
2602027|NCT02147158|Secondary|Time to Absence of Bleeding on Treatment During Treatment Course 2|Time to absence of bleeding is defined as the duration in days from first dose in treatment course 2 to the first day in the time interval in which absence of bleeding occurs and persists through the last dose in the second treatment course. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose in Treatment Course 2.|From first dose up to the end of treatment in the 12-Week Treatment Course 2|Data was summarized as per treatment assigned. Number of participants analyzed are participants with data available for analysis at the given timepoint.|||days||97.5% Confidence Interval|Median
2602028|NCT02147158|Secondary|Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 2|Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in Treatment Course 2.|Last 35 consecutive days on treatment in the 12-Week Treatment Course 2|Data was summarized as per the treatment assigned. Number of participants analyzed are participants with data available for analysis at the given timepoint.|||percentage of participants||97.5% Confidence Interval|Number
2602029|NCT02147158|Secondary|Percentage of Participants With Absence of Bleeding From Day 11 Through the End of Treatment Course 1|Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), from Day 11 to the end of treatment in Treatment Course 1.|Day 11 through the end of treatment in the 12-Week Treatment Course 1|ITT population included all randomized participants. Data was summarized as per the treatment assigned.|||percentage of participants||97.5% Confidence Interval|Number
2602030|NCT02147158|Primary|Time to Absence of Bleeding on Treatment During Treatment Course 1|Time to absence of bleeding was defined as the duration in days from first dose to the first day in the time interval in which absence of bleeding occurs and persists through the last dose in the first treatment course. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose in Treatment Course 1.|From first dose up to the end of the 12-Week Treatment Course 1|ITT population included all randomized participants. Data was summarized per treatment assigned.|||days||97.5% Confidence Interval|Median
2602031|NCT02147158|Primary|Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1|Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in Treatment Course 1.|Last 35 consecutive days on treatment in the 12-Week Treatment Course 1|Intent-to-Treat (ITT) Population included all randomized participants. Data was summarized as per the treatment assigned.|||percentage of participants||97.5% Confidence Interval|Number
2602032|NCT02147132|Secondary|Number of Participants With Carbon Monoxide Levels Less Than or Equal to 8 Parts-per-million|Carbon monoxide (CO) in each participant's breath will be tested. A CO level less than or equal to 8 parts-per-million will be used to verify reports of no smoking.|up to 8 weeks|Varenicline and placebo varenicline analysis populations are less than 7 because 1 participant was lost to follow-up and provided no data for these assigned medications.|||Participants|||Count of Participants
2602033|NCT02147132|Secondary|Cigarettes Per Day|The Quitbit lighter will measure how many cigarettes are smoked per day. In addition to the Quitbit lighter measurement, the Timeline Follow Back (TLFB) form will be filled out for each subject to measure use, as well.|7 weeks|Varenicline and placebo varenicline analysis populations are less than 7 because 1 participant was lost to follow-up and provided no data for these assigned medications.|||cigarettes per day||Standard Deviation|Mean
2602137|NCT02146105|Secondary|Change in Biomechanical Outcomes|Participants will be asked to partake in a complete kinematic, kinetic, and electromyographic analysis of gait and static postures using floor-embedded force plates, a 9-camera motion capture system, and a wireless electromyography system. Knee adduction moment (KAM; Nm/kg), normalized electromyography to a percentage of their maximal effort (%MVIC), and muscular co-activation (%) are the variables of interest.|Week 1 and Week 13|||||||
2602034|NCT02147132|Primary|Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose|Subjects will be given a special electronic cigarette lighter called Quitbit.The electronic lighter will record a timestamp for each time the lighter is used to light a cigarette. Data will be collected from the lighter at each study visit. This will measure how many cigarettes are smoked and when.|7 weeks|Varenicline and placebo varenicline analysis populations are less than 7 because 1 participant was lost to follow-up and provided no data for these assigned medications.|||proportion of daily cigarettes||Standard Deviation|Mean
2602035|NCT02147093|Primary|Near LogMAR Visual Acuity|Near time controlled LogMAR Visual Acuity was carried out binocularly, at 4cm under 250 cd/m^2 and 50 cd/m^2 luminance. The test was presented on under the two conditions; High Luminance (250cd/m^2) High Contrast (90%) & Low Contrast (10%) and Low Luminance (50cd/m^2) High Contrast (90%)|7 days post wear|All subjects that completed all study visits without a major protocol deviation.|||LogMAR||Standard Deviation|Mean
2602036|NCT02147093|Primary|Distance LogMAR Visual Acuity|Distance time controlled LogMAR (Logarithm of the Minimum Angle of Resolution) Visual Acuity was carried out binocularly, at 4m (meter) under 250 cd/m^2 and 2.5 cd/m^2 (candela per square meter) luminance. The test was presented under the two conditions; High luminance (250 cd/m^2) High Contrast (90%) & Low Contrast (10%) and Low Luminance (2.5 cd/m^2) High Contrast (90%)|7 days post wear|All subjects that completed all study visits without a major protocol deviation.|||LogMAR||Standard Deviation|Mean
2602037|NCT02147067|Secondary|Percent Change in Coronary Blood Flow|Coronary endothelial function will also be evaluated by measurement of coronary blood flow during infusion of intracoronary acetylcholine. Coronary blood flow (CBF) is defined as diameter (D)2 x APV / 8. Percent change in CBF (%ΔCBF) is calculated by (CBFACh - CBFbaseline) / CBFbaseline x 100%, where a >50% increase in CBF in response to acetylcholine is considered normal.|Baseline, Week 12|Data for this outcome measure was not collected.||||||
2602038|NCT02147067|Secondary|Change in Hyperemic Microcirculatory Resistance (HMR)|Change in Hyperemic Microcirculatory Resistance (HMR) after 12 weeks therapy with ranolazine compared with placebo. Average peak velocity (APV) was assessed over a 3- to 5-beats period. HMR was measured as the ratio of distal pressure to APV. Change at 12 weeks was calculated as (Endpoint Value at 12 weeks - Endpoint Value at Baseline)/Endpoint Value at Baseline. Higher HMR is associated with myocardial ischemia and a positive value for change in HMR indicates increased risk for cardiac events at the week 12 visit.|Baseline, Week 12||||mmHg/cm/s||Standard Deviation|Mean
2602039|NCT02147067|Secondary|Change in Coronary Flow Reserve (CFR)|The changes in Coronary Flow Reserve (CFR) after 12 weeks therapy with ranolazine compared with placebo are presented here. CFR is a measurement of the maximum increase of blood flow through the coronary arteries during exercise. Average peak velocity (APV) was assessed over a 3- to 5-beats period. CFR was defined as the ratio of hyperemic to basal APV. A low CFR is an indication of coronary artery disease. Change at 12 weeks was calculated as (Endpoint Value at 12 weeks - Endpoint Value at Baseline)/Endpoint Value at Baseline. A positive value for the change in CFR suggests improvement in coronary artery blood flow between the baseline and week 12 visits.|Baseline, Week 12||||ratio of hyperemic to basal APV||Standard Deviation|Mean
2602040|NCT02147067|Secondary|Change in Metabolic Equivalents of Task (METs) at Peak|Change in exercise was measured as Metabolic Equivalents of Task (METs) at Peak by cardiopulmonary exercise testing (CPET) after 12 weeks therapy with ranolazine compared with placebo. METs are used to describe functional aerobic capacity and harder physical tasks require a higher number of METs. METs at a peak level of exercise was determined for each participant. Change at 12 weeks was calculated as (Endpoint Value at 12 weeks - Endpoint Value at Baseline)/Endpoint Value at Baseline. A positive value for change in METs at Peak of exercise indicates that the participant has improved their aerobic capacity from baseline at the week 12 visit.|Baseline, Week 12||||3.5ml of oxygen/kg per min||Standard Deviation|Mean
2602041|NCT02147067|Secondary|Change in Time to Angina|Change in time to angina as measured by cardiopulmonary exercise testing after 12 weeks therapy with Ranolazine compared with placebo. Change at 12 weeks was calculated as (Endpoint Value at 12 weeks - Endpoint Value at Baseline)/Endpoint Value at Baseline.|Baseline, Week 12|Data for this outcome measure was not collected.||||||
2602042|NCT02147067|Secondary|Change in Peak Rate of Oxygen Consumption (VO2 Max)|The change in VO2, as measured by cardiopulmonary exercise testing (CPET), after 12 weeks therapy with ranolazine compared with placebo. VO2 max is the maximum amount of oxygen the participants are utilizing during intense treatment. To standardize exercise stress testing, CPET was performed under the guidance of the MET-TEST CPET network in Atlanta, Georgia. The MET-TEST was created in 2003 and is a high-precision stress test with detailed physiological assessment, allowing accurate and reproducible measurements of peak VO2. Individuals may demonstrate an abnormal CPET response before they develop symptoms or present with cardiac events and abnormal CPET results are strong predictors of future adverse outcomes. Higher VO2 values indicate better oxygen utility and positive value for VO2 change means there was improvement from baseline at the week 12 visit. Change at 12 weeks was calculated as (Endpoint Value at 12 weeks - Endpoint Value at Baseline)/Endpoint Value at Baseline.|Baseline, Week 12||||L/min||Standard Deviation|Mean
2602043|NCT02147067|Secondary|Change in Seattle Angina Questionnaire Score Regarding Disease Perception|The change in scores of the disease perception dimension of the Seattle Angina Questionnaire (SAQ) after 12 weeks therapy with ranolazine or placebo are presented. Change at 12 weeks was calculated as (Endpoint Value at 12 weeks - Endpoint Value at Baseline)/Endpoint Value at Baseline. Individual dimensions of the Seattle Angina Questionnaire are transformed to be a score from 0 to 100, where higher scores indicate better health. A positive number for the disease perception dimension means that the participants felt that their disease impacted their quality of life less at week 12 than at the baseline visit.|Baseline, Week 12||||score on a scale||Standard Deviation|Mean
2602044|NCT02147067|Secondary|Change in Seattle Angina Questionnaire Score Regarding Treatment Satisfaction|The change in scores of the treatment satisfaction dimension of the Seattle Angina Questionnaire (SAQ) after 12 weeks therapy with ranolazine or placebo are presented. Change at 12 weeks was calculated as (Endpoint Value at 12 weeks - Endpoint Value at Baseline)/Endpoint Value at Baseline. Individual dimensions of the Seattle Angina Questionnaire are transformed to be a score from 0 to 100, where higher scores indicate better health. A positive number for the treatment satisfaction dimension means that the participants are experiencing greater satisfaction with their treatment at week 12 than they were at the baseline visit.|Baseline, Week 12||||score on a scale||Standard Deviation|Mean
2602045|NCT02147067|Secondary|Change in Seattle Angina Questionnaire Score Regarding Angina Stability|The change in scores of the angina stability dimension of the Seattle Angina Questionnaire (SAQ) after 12 weeks therapy with ranolazine or placebo are presented. Change at 12 weeks was calculated as (Endpoint Value at 12 weeks - Endpoint Value at Baseline)/Endpoint Value at Baseline. Individual dimensions of the Seattle Angina Questionnaire are transformed to be a score from 0 to 100, where higher scores indicate better health. A positive number for the angina stability dimension means that the participants are experiencing fewer changes in their angina at week 12 than they were at the baseline visit.|Baseline, Week 12||||score on a scale||Standard Deviation|Mean
2602046|NCT02147067|Secondary|Change in Seattle Angina Questionnaire Score Regarding Physical Limitation|The change in scores of the physical limitation dimension of the Seattle Angina Questionnaire (SAQ) after 12 weeks therapy with ranolazine or placebo are presented. Change at 12 weeks was calculated as (Endpoint Value at 12 weeks - Endpoint Value at Baseline)/Endpoint Value at Baseline. Individual dimensions of the Seattle Angina Questionnaire are transformed to be a score from 0 to 100, where higher scores indicate better health. A positive number for the physical limitation dimension means that the participants are experiencing less limitation at week 12 than they were at the baseline visit.|Baseline, Week 12||||score on a scale||Standard Deviation|Mean
2602047|NCT02147067|Primary|Change in Seattle Angina Questionnaire Score Regarding Angina Frequency|The change in scores of the angina frequency dimension of the Seattle Angina Questionnaire (SAQ) after 12 weeks therapy with ranolazine or placebo are presented. Change at 12 weeks was calculated as (Endpoint Value at 12 weeks - Endpoint Value at Baseline)/Endpoint Value at Baseline. Individual dimensions of the Seattle Angina Questionnaire are transformed to be a score from 0 to 100, where higher scores indicate better health. A positive number for the angina frequency dimension means that the participants are experiencing fewer episodes of angina at week 12 than they were at the baseline visit.|Baseline, Week 12||||score on a scale||Standard Deviation|Mean
2602048|NCT02146599|Primary|Use of Corrective Visual Aids (i.e., Spectacles, Contact Lenses) Post Intraocular Lens (IOL) Surgery|Patients will be assessed at a baseline visit and a visit 1 week later to determine their use of corrective visual aids (i.e., spectacles, contact lenses) post Intraocular Lens (IOL) surgery.|Baseline and 1 week|Of the 295 participants who provided data for this analysis (monofocal participants , n=138; accommodating participants, n=34; and multifocal participants, n=123), corrective visual aids (i.e., spectacles, contact lenses) post intraocular lens (IOL) surgery were required by 88 participants.|||participants|||Number
2602049|NCT02146482|Secondary|Change in Pain in Other Body Parts|The Brief Pain Inventory (BPI) allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. This data was not analyzed due to the focus of the project on lower back pain.|At the conclusion of each work day for 12 weeks and 8 weeks later|||||||
2602050|NCT02146482|Primary|Change in Back Pain|The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The patient is asked to agree or disagree with 24 different statements related to their back pain. The end score is the sum of the agreed statements. The score ranges from 0 (no disability) to 24 (maximum disability).|Baseline (Week 1) and Follow-Up (Week 18)||||units on a scale||Full Range|Median
2602051|NCT02146365|Secondary|Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx|"The density of Streptococcus pneumoniae serotype NT4b in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.|||log LytA copies||95% Confidence Interval|Median
2602052|NCT02146365|Secondary|Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx|"The density of Streptococcus pneumoniae serotype 6A/B [6A] in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.|||log LytA copies||95% Confidence Interval|Median
2602053|NCT02146365|Secondary|Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx|"The density of Streptococcus pneumoniae serotype 35B in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.|||log LytA copies||95% Confidence Interval|Median
2602090|NCT02146326|Secondary|Patient Engagement-Missed Appointments|Patient engagement was assessed by the proportion of missed appointments (when the client cancelled or did not show for a scheduled appointment divided by the total scheduled). This data was retrieved from client medical records at the agencies. Data from 3 time periods were analyzed (6 months prior to baseline through baseline, baseline to 6 months, and 6 months to 12 months). The below table illustrates the missed appointments for each time period.|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to missing data (medical records not available) and clients discontinuing treatment at their respective agency.|||appointments at mental health agency||Standard Deviation|Mean
2602054|NCT02146365|Secondary|Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx|"The density of Streptococcus pneumoniae serotype 3 in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.|||log LytA copies||95% Confidence Interval|Median
2602055|NCT02146365|Secondary|Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx|"The density of Streptococcus pneumoniae serotype 19F in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.|||log LytA copies||95% Confidence Interval|Median
2602056|NCT02146365|Secondary|Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx|"The density of Streptococcus pneumoniae serotype 19A in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.|||log LytA copies||95% Confidence Interval|Median
2602057|NCT02146365|Secondary|Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx|"The density of Streptococcus pneumoniae serotype 15B/C [15B] in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.|||log LytA copies||95% Confidence Interval|Median
2602058|NCT02146365|Secondary|Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx|"The density of Streptococcus pneumoniae serotype 15A in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.|||log LytA copies||95% Confidence Interval|Median
2602059|NCT02146365|Secondary|Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx|"The density of Streptococcus pneumoniae serotype 13 in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.|||log LytA copies||95% Confidence Interval|Median
2602060|NCT02146365|Secondary|Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx|"The density of Streptococcus pneumoniae serotype 11A/D/E [11A] in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|NPC population with culture-confirmed samples and a relative abundance greater than zero for the serotype.|||log LytA copies||95% Confidence Interval|Median
2602091|NCT02146326|Secondary|Quality of Care Total|Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.) and then refined to 22 items through data collected and analyzed in this study. This scale for clients was adapted from the one developed for staff. Item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602061|NCT02146365|Secondary|Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx|"Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype NT4b is reported.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point|||Participants|||Count of Participants
2602062|NCT02146365|Secondary|Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx|"Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 6A/B [6A] is reported.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point|||Participants|||Count of Participants
2602063|NCT02146365|Secondary|Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx|"Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 35B is reported.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point|||Participants|||Count of Participants
2602064|NCT02146365|Secondary|Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx|"Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 3 is reported.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point|||Participants|||Count of Participants
2602065|NCT02146365|Secondary|Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx|"Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 19F is reported.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point|||Participants|||Count of Participants
2602066|NCT02146365|Secondary|Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx|"Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 19A is reported.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point|||Participants|||Count of Participants
2602067|NCT02146365|Secondary|Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx|"Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 15B/C [15B] is reported.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point|||Participants|||Count of Participants
2602092|NCT02146326|Secondary|Quality of Care-Inattentive Care|Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.). This scale for clients was adapted from the one developed for staff. Inattentive care was measured with a subset of questions from this scale. Item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602068|NCT02146365|Secondary|Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx|"Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 15A is reported.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point|||Participants|||Count of Participants
2602069|NCT02146365|Secondary|Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx|"Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 13 is reported.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point|||Participants|||Count of Participants
2602070|NCT02146365|Secondary|Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx|"Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 11A/D/E [11A] is reported.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|Nasopharyngeal Carriage (NPC) population with culture-confirmed samples and available serotype data at each time point|||Participants|||Count of Participants
2602071|NCT02146365|Secondary|Number of Adverse Events (AE)|An AE was defined as any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or psychological/physiologic observations occurring in a person in a clinical study. The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.|32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.|All enrolled participants|||adverse events|||Number
2602072|NCT02146365|Secondary|Number of Participants With Neutralizing Antibody Response to Pneumolysin|"Neutralizing antibody responses to pneumolysin were assessed at Baseline and 6 months post vaccination 2 using an in vitro toxin neutralization assay that measures the ability of antibodies to neutralize wild-type pneumolysin-induced lysis of rabbit red blood cells.~Each sample was categorized as negative (< 1/20 dilution) or positive (with titer between 1/20 and 1/320 dilution). Responses at higher dilutions indicate higher levels of neutralizing antibodies to pneumolysin."|Baseline (Week 0) and 6 months post-vaccination 2 (Week 32)|Immunogenicity Population with available neutralizing antibody data.|||Participants|||Count of Participants
2602073|NCT02146365|Secondary|Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2|"The percentage of participants with a seroresponse, defined as a ≥ 2, ≥ 3, and ≥ 4 fold-rise above Baseline in IgG antibody levels against Pneumococcal proteins. Fold-rise was calculated as the 6-month post-vaccination (Week 32) IgG response divided by the Baseline IgG level.~Immunogenicity was evaluated based on the following assays:~IgG response to pneumolysoid [L460D] and pneumococcal surface protein A family 1 [PspA-Fam1] was measured by enzyme-linked immunosorbent assay (ELISA).~IgG response to the following pneumococcal proteins was measured using the Meso Scale Discovery (MSD) platform:~L460D~PspA-Fam1~Pneumococcal histidine triad D (PhtD)~Boston Children's Hospital protein 785 (BCH0785)~Serine threonine kinase protein (StkP)~Pneumococcal choline-binding protein A (PcpA)~Streptococcus pneumonia whole cell antigen (SPWCA)~Pneumococcal iron uptake protein A (PiuA)~Pneumococcal iron acquisition protein A (PiaA)"|Baseline and Week 32|Immunogenicity Population|||percentage of participants||90% Confidence Interval|Number
2602074|NCT02146365|Secondary|Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins|"Immunogenicity was evaluated based on the following assays:~IgG response to pneumolysoid [L460D] and pneumococcal surface protein A family 1 [PspA-Fam1] was measured by enzyme-linked immunosorbent assay (ELISA).~IgG response to the following pneumococcal proteins was measured using the Meso Scale Discovery (MSD) platform:~L460D~PspA-Fam1~Pneumococcal histidine triad D (PhtD)~Boston Children's Hospital protein 785 (BCH0785)~Serine threonine kinase protein (StkP)~Pneumococcal choline-binding protein A (PcpA)~Streptococcus pneumonia whole cell antigen (SPWCA)~Pneumococcal iron uptake protein A (PiuA)~Pneumococcal iron acquisition protein A (PiaA)~The fold-change was calculated as the 6-month post-vaccination (Week 32) IgG response divided by the Baseline IgG response."|Baseline and Week 32|Immunogenicity Population|||fold-change||90% Confidence Interval|Geometric Mean
2602093|NCT02146326|Secondary|Quality of Care-Negative Interactions|Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.). This scale for clients was adapted from the one developed for staff. Negative Interactions were measured with a subset of questions from this scale. Item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602170|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of All-cause Death, MI or SRI-UR Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of all-cause death, MI or SRI-UR through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602075|NCT02146365|Secondary|Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group|"Data reported are the geometric mean concentration at 6 months post-vaccination 2 (Week 32) for each PATH-wSP group divided by the Booster (Synflorix and Pentavax)-only group (N=38). Immunogenicity was evaluated based on the following assays:~Immunoglobulin (IgG) response to pneumolysoid (L460D) and pneumococcal surface protein A family 1 (PspA-Fam1) was measured by enzyme-linked immunosorbent assay (ELISA).~IgG response to the following pneumococcal proteins was measured using the Meso Scale Discovery (MSD) platform:~L460D~PspA-Fam1~Pneumococcal histidine triad D (PhtD)~Boston Children's Hospital protein 785 (BCH0785)~Serine threonine kinase protein (StkP)~Pneumococcal choline-binding protein A (PcpA)~Streptococcus pneumonia whole cell antigen (SPWCA)~Pneumococcal iron uptake protein A (PiuA)~Pneumococcal iron acquisition protein A (PiaA)"|Week 32|Immunogenicity population|||ratio||90% Confidence Interval|Number
2602076|NCT02146365|Secondary|Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins|"Immunogenicity was evaluated based on the following assays:~Immunoglobulin (IgG) response to pneumolysoid [L460D] and pneumococcal surface protein A family 1 [PspA-Fam1] was measured by enzyme-linked immunosorbent assay (ELISA).~IgG response to the following pneumococcal proteins was measured using the Meso Scale Discovery (MSD) platform:~L460D~PspA-Fam1~Pneumococcal histidine triad D (PhtD)~Boston Children's Hospital protein 785 (BCH0785)~Serine threonine kinase protein (StkP)~Pneumococcal choline-binding protein A (PcpA)~Streptococcus pneumonia whole cell antigen (SPWCA)~Pneumococcal iron uptake protein A (PiuA)~Pneumococcal iron acquisition protein A (PiaA)"|Baseline (Week 0), 4 weeks post-vaccination 2 (Week 12), and 6 months post-vaccination 2 (Week 32).|The Immunogenicity (IG) population includes participants enrolled in Study VAC-010 with at least one usable value in the VAC-011 immunogenicity data set. VAC-010 participants who did not receive both vaccinations were excluded.|||titer||90% Confidence Interval|Geometric Mean
2602077|NCT02146365|Primary|Density of Streptococcus Pneumoniae in the Nasopharynx|"The density of Streptococcus pneumoniae (SPn) in the nasopharynx was measured by the number of autolysin (LytA) gene copies detected by quantitative polymerase chain reaction (qPCR) from nasopharyngeal swabs taken at each study visit.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only plus non-interventional group enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|The Nasopharyngeal Carriage (NPC) population with available LytA data at each time point|||log LytA copies||95% Confidence Interval|Median
2602078|NCT02146365|Primary|Prevalence of Streptococcus Pneumoniae in Nasopharynx|"The prevalence of Streptococcus pneumoniae (SPn) in the nasopharynx was measured by the number (and percentage) of participants positive for SPn detected by quantitative polymerase chain reaction (qPCR) from nasopharyngeal swabs taken at each study visit.~NPC endpoints were analyzed within combined study groups:~PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster~Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only plus non-interventional participants enrolled during Cohort 1~PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster~Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only plus non-interventional participants enrolled during Cohort 2"|Week 0, Week 12, Week 16, Week 20, Week 32|The Nasopharyngeal Carriage (NPC) population included enrolled participants with at least one post-enrollment swab measurement not associated with a protocol violation that may have interfered with the assessment of NPC outcomes. VAC-010 participants who did not receive both vaccinations were excluded.|||Participants|||Count of Participants
2602079|NCT02146352|Secondary|Technical Success Outcome Measure 2|Technical Success: Successful removal of AXIOS stent using standard endoscopic snare or forceps|30 or 60 Day Post-procedure|Per Protocol|||percentage of patients|||Number
2602080|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 6|Freedom from serious adverse event associated with the AXIOS stent and/or (index) implant procedure|Index procedure through 1-week post-stent removal|Entire patient cohort|||percentage of patients|||Number
2602081|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 5|Freedom from tissue injury, defined as ulceration at site of stent implant as observed to persist through 1-week post-stent removal|Index procedure through 1-week post-stent removal|Patients for which AXIOS stent was removed and tissue at site of stent implant was observed at time of removal|||percentage of patients|||Number
2602082|NCT02146352|Primary|Safety/Adverse Event Outcome 4|Freedom from stent migration/dislodgement into the pseudocyst or enteral lumen|Index procedure through 1-week post-stent removal|Patients for which AXIOS stent migration/dislodgement could be assessed|||percentage of patients|||Number
2602083|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 3|Freedom from surgery for access-site related perforation|Index procedure through 1-week post-stent removal|Entire patient cohort|||percentage of patients|||Number
2602084|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 2|Freedom from access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization|Index procedure through 1-week post-stent removal|Entire patient cohort|||percentage of patients|||Number
2602085|NCT02146352|Secondary|Clinical Success Outcome Measure|Clinical success: At least a 50% decrease in pseudocyst size at 30 days or 60 days|30 or 60 days post-procedure|Entire patient cohort|||percentage of patients|||Number
2602086|NCT02146352|Secondary|Technical Success Outcome Measure 1|Technical success: Successful placement of the AXIOS stent using the Electrocautery Enhanced AXIOS Delivery System|Index Procedure|Per Protocol|||percentage of patients|||Number
2602087|NCT02146352|Secondary|Lumen Patency Outcome Measure|Lumen Patency: The stent lumen must be patent at 30 days and/or 60 days of implantation.|30 and/or 60 days post-procedure|Per Protocol|||percentage of patients|||Number
2602088|NCT02146352|Secondary|Stent Retention Outcome Measure|Stent Retention: The stent must remain in place for up to 60 days|30 or 60 days post-procedure|Per Protocol Population|||percentage of patients|||Number
2602089|NCT02146352|Primary|Safety/Adverse Event Outcome Measure 1|Freedom from access site-related bleeding requiring transfusion|Index procedure through 1-week post-stent removal|Entire patient cohort|||percentage of patients|||Number
2602094|NCT02146326|Secondary|Quality of Care-Person Centered Care|Perceived Quality of Care was assessed with a 31 item scale (e.g., Staff spent extra time with me when I needed them.). This scale for clients was adapted from the one developed for staff. Person Centered Care was measured with a subset of questions from this scale. The item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602095|NCT02146326|Secondary|Client Satisfaction Questionnaire|Engagement was assessed with patient satisfaction using the Client Satisfaction Questionnaire, an 8-item satisfaction checklist (e.g., How would you rate the quality of service you have received? and, If a friend were in need of similar help, would you recommend [name of agency] to him or her?). The item scores were averaged. Scale: 1 to 4 with response text dependent upon the question (e.g., 1-Poor to 4-Excellent, 1-No, definitely not to 4-Yes, definitely, or 1-Quite dissatisfied to 4-Very satisfied).|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602096|NCT02146326|Secondary|Generalized Anxiety Disorder (GAD-7)|"Anxiety was assessed with the 7-item Generalized Anxiety Disorder (GAD-7). It can be scored continuously on a 0-21 severity scale and cutpoints have been established for estimating the probability of the 4 most common and clinically relevant anxiety disorders - generalized anxiety disorder, panic disorder, post-traumatic stress disorder, and social anxiety disorder. Scale: 0 (not at all), 1 (several days), 2 (more than half the days), 3 (nearly every day)~Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Archives of Internal Medicine. May 22 2006;166(10):1092-1097.~Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. Mar 6 2007;146(5):317-325."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602097|NCT02146326|Secondary|Patient Health Questionnaire 9-item (PHQ-9)|"The PHQ-9 is a brief, self-report assessment. It provides a summed total score that indicates likelihood of major depressive disorder. Scores ≥10 are considered a positive screen (sensitivity 88%, specificity 88%) and also effectively measures response to treatment (<5 indicate remission, of 5-9 indicate partial response, and ≥10 indicates no response). Item scores are summed and averaged (range: 0-27). Scale: 0 (Not at all), 1 (Several days), 2 (More than half the days), 4 (Nearly every day). When problems are identified, the difficulty of those problems are rated on 4 point scale (Not difficult at all to Extremely difficult).~Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. Journal of General Internal Medicine. Sep 2001;16(9):606-613.~American Psychiatric Association. Diagnostic and statistical manual of mental disorders - Text Revision (4th ed.). Washington, DC: American Psychiatric Association; 2000."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602098|NCT02146326|Secondary|Short-Form Health Survey (SF-12)-Mental Health Functioning|"Physical and mental health functioning was assessed with the Short Form 12-Item Health Survey (SF-12). The SF-12 is a health-related quality of life measure, derived from the 36-item Medical Outcomes Study survey and containing items yielding a Mental Health Component Score and a Physical Health Component Score. Higher composite scores indicate higher health-related quality of life. Items are weighted and then transformed into norm-based scores (range: 0-100).~Ware JE, Jr. , Kosinski M, Keller SD. A 12-item short-form health survey: Construction of scales and preliminary tests of reliability and validity. Medical Care. 1996;34(3):220 -233."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602099|NCT02146326|Secondary|Short-Form Health Survey (SF-12)-Physical Health Functioning|"Physical and mental health functioning was assessed with the Short Form 12-Item Health Survey (SF-12). The SF-12 is a health-related quality of life measure, derived from the 36-item Medical Outcomes Study survey and containing items yielding a Mental Health Component Score and a Physical Health Component Score. Higher composite scores indicate higher health-related quality of life. Items are weighted and then transformed into norm-based scores (range: 0-100).~Ware JE, Jr. , Kosinski M, Keller SD. A 12-item short-form health survey: Construction of scales and preliminary tests of reliability and validity. Medical Care. 1996;34(3):220 -233."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602100|NCT02146326|Secondary|Patient Activation Measure-Mental Health (PAM-MH)-0 to 100 Scale|"Competence related to mental health management was assessed with the 13-item Patient Activation Measure-Mental Health (PAM-MH) (e.g., I know what each of my prescribed mental health medications does.). Each question was answered on a 4-point Likert-type scale: 1 (Strongly Disagree) to 4 (Strongly Agree). Higher scores=greater activation.~Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Services Research. Dec 2005;40(6 Pt 1):1918-1930."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602101|NCT02146326|Secondary|Working Alliance Inventory (WAI) - Bonds Subscale|"Perceived relatedness was assessed with this short form of the patient version of the WAI and has 12 items in total. This outcome is for the bonds subscale. Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The items scores were summed and averaged (range: 4-28). Scale: 1 (Never) to 7 (Always)~Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation.|||units on a scale||Standard Deviation|Mean
2602102|NCT02146326|Secondary|Working Alliance Inventory (WAI) - Goals Subscale|"Perceived relatedness was assessed with this short form of the patient version of the WAI and has 12 items in total. This outcome is for the goals subscale. Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The items scores were summed and averaged (range: 4-28). Scale: 1 (Never) to 7 (Always)~Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation.|||units on a scale||Standard Deviation|Mean
2602103|NCT02146326|Secondary|Working Alliance Inventory (WAI) - Tasks Subscale|"Perceived relatedness was assessed with this short form of the patient version of the WAI and has 12 items in total. This outcome is for the tasks subscale. Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The item scores were summed and averaged (range: 4-28). Scale: 1 (Never) to 7 (Always)~Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation.|||units on a scale||Standard Deviation|Mean
2602104|NCT02146326|Secondary|Working Alliance Inventory (WAI)|"Perceived relatedness was assessed with this short form of the patient version of the WAI and is 12 items (e.g., We agree on what is important for me to work on.). Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The item scores were averaged. Scale: 1 (Never) to 7 (Always)~Tracey TJ, Kokotovic AM. Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology. 1989;1(3):207."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation.|||units on a scale||Standard Deviation|Mean
2602105|NCT02146326|Secondary|Health-Care Climate Questionnaire|"Perceived autonomy support was assessed with this 15-item scale (e.g., I am able to be open with [name] at our meetings.). Clients were prompted to report on the specific clinician from whose caseload they were randomly selected. The item scores were averaged. Scale: 1 (Strongly Disagree) to 7 (Strongly Agree)~Williams GC, McGregor HA, King D, Nelson CC, Glasgow RE. Variation in perceived competence, glycemic control, and patient satisfaction: relationship to autonomy support from physicians. Patient Education & Counseling. Apr 2005;57(1):39-45."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data. Some clients did not recall the clinician being asked about and/or discontinued treatment with that clinician during their study participation.|||units on a scale||Standard Deviation|Mean
2602106|NCT02146326|Secondary|Medication Adherence Rating Scale (MARS) - Medication Attitudes - 10-item|"Medication attitudes (for clients who are prescribed medications for their mental health) was rated with the MARS, a 10-item scale assessing attitudes toward medication (e.g., It is unnatural for my mind and body to be controlled by medication.). The items scores were summed and averaged (range: 0-10). Scale: 0 (No) to 1 (Yes)~Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophrenia Research. May 5 2000;42(3):241-247."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out, clients who reported they are not prescribed medications for their mental health, and/or missing data.|||units on a scale||Standard Deviation|Mean
2602107|NCT02146326|Secondary|Medication Adherence Rating Scale (MARS) - Medication Adherence - 4-item|"Medication adherence (for clients who are prescribed medications for their mental health) was rated with a subset of 4 items from the MARS, a 10-item scale assessing attitudes toward medication (e.g., Do you ever forget to take your medication? Are you careless at times about taking your medicine?). The item scores were summed and averaged (range: 0-4). Scale: 0 (No) to 1 (Yes)~Thompson K, Kulkarni J, Sergejew AA. Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophrenia Research. May 5 2000;42(3):241-247."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out, clients reporting they are not prescribed medications for their mental health, and/or missing data.|||units on a scale||Standard Deviation|Mean
2602108|NCT02146326|Secondary|Adult State Hope Scale|"Hope was assessed with clients using the 12-item Adult State Hope Scale (e.g., I can think of many ways to get the things in life that are most important to me.). The item scores were averaged. Scale: 1 (Definitely False) to 8 (Definitely True)~Snyder CR, Sympson SC, Ybasco FC, Borders TF, Babyak MA, Higgins RL. Development and validation of the State Hope Scale. Journal of Personality and Social Psychology. 1996;70(2):321 - 335."|Measured with clients at baseline, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602109|NCT02146326|Secondary|Staff Turnover|Number of staff participants who separated from their respective agency before their anticipated study completion date. The mental health agencies provided separation dates, if applicable, for staff study participants.|Measured with staff at 12 months||||Participants|||Count of Participants
2602110|NCT02146326|Secondary|Perceptions of Supervisory Support|The 19 item Perceptions of Supervisory Support Scale was used to gather information on staff's experience of interactions with their supervisors (e.g., How often did you think supervision improved your relationship with your supervisor?). The item scores were averaged. Scale: 1 (never) to 6 (always)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602719|NCT02139137|Secondary|Change in General Anxiety: Spielberger State-Trait Anxiety Inventory|Range: 20-80; higher scores indicate greater symptom severity|Baseline, Week 4||||units on a scale||Standard Deviation|Mean
2602111|NCT02146326|Secondary|Quality of Care-Total|Perceived Quality of Care was assessed with a 31 item scale developed with one of the mental health agencies participating in this project and then refined to 22 items through data collected and analyzed in this study. Items were related to person or client centered care, work conscientiousness, errors, interactions with clients, and how stress affects client interactions or outcomes. The item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602112|NCT02146326|Secondary|Quality of Care: Discordant Care|Perceived Quality of Care was assessed with a 31 item scale developed with one of the mental health agencies as part of this project. Discordant Care was measured with a subset of questions from this scale (e.g., I had conflicts with clients.). The item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602113|NCT02146326|Secondary|Quality of Care: Person Centered Care|Perceived Quality of Care was assessed with a 31 item scale developed with one of the mental health agencies as part of this project. Person Centered Care was measured with a subset of questions from this scale (e.g., I felt like I was able to really show compassion to a client.). The item scores were averaged. Scale: 0 (never) to 5 (always)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602114|NCT02146326|Secondary|Confidence: Client Interaction|"Staff were asked, How confident are you that you can consistently interact with consumers/clients in a relaxed, non-judgmental way? Scale: 1 (not at all confident) to 10 (extremely confident)"|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602115|NCT02146326|Secondary|Importance: Client Interaction|"Staff were asked, How important is it for you to consistently interact with consumers/clients in a relaxed, non-judgmental way? Scale: 1 (not at all important) to 10 (extremely important)"|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602116|NCT02146326|Secondary|Confidence: Reduce Work-Related Stress|"Staff were asked, How confident are you that you can reduce your work-related stress in your life? Scale: 1 (not at all confident) to 10 (extremely confident)"|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602117|NCT02146326|Secondary|Importance: Reduce Work-Related Stress|"Staff were asked, How important is it for you to reduce your work-related stress right now? This single item score was averaged. Scale: 1 (not at all important) to 10 (extremely important)"|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602118|NCT02146326|Secondary|Emotional Labor Scale: Genuine Emotions|The Emotional Labor Scale includes 14 questions regarding the relationship between emotions and interactions with clients. Genuine Emotions is a subset of these questions (e.g., The emotions that I express to clients are genuine). The item scores were averaged. Scale: 1 (strongly disagree) to 5 (strongly agree)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602119|NCT02146326|Secondary|Emotional Labor Scale: Deep Acting|The Emotional Labor Scale includes 14 questions regarding the relationship between emotions and interactions with clients. Deep Acting is a subset of these questions (e.g., I try to actually experience the emotions that I must show to clients). The item scores were averaged. Scale: 1 (strongly disagree) to 5 (strongly agree)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602120|NCT02146326|Secondary|Emotional Labor Scale: Surface Acting|The Emotional Labor Scale includes 14 questions regarding the relationship between emotions and interactions with clients. Surface Acting is a subset of these questions (e.g., I put on an act in order to deal with clients in an appropriate way). The item scores were averaged. Scale: 1 (strongly disagree) to 5 (strongly agree)|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602121|NCT02146326|Secondary|Home Life Interference With Work|"Work-Life Balance was assessed with a six-item measure adapted from an 18-item measure developed by Carlson et al. The measure assesses three types (time-, strain-, and behavior-based) and two directions (work conflict with family and family conflict with work) of balance. The outcome described here is family conflict with work. The measure consists of a series of statements regarding one's work and family situation, to which participants are asked to indicate their level of agreement or disagreement on a 5-point Likert-type scale: 1 (Strongly disagree) to 5 (Strongly agree). The item scores were averaged.~Carlson DS, Kacmar KM, Williams LJ. Construction and initial validation of a multidimensional measure of work-family conflict. Journal of Vocational Behavior. 2000;56(2):249-276."|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602136|NCT02146131|Primary|Diagnostic Yield of Procedures; Number of Positive Diagnosis of Pulmonary Lesions|Diagnostic yield of standard FB with fluoroscopy using standard adult bronchoscope versus bronchoscopy using ultrathin bronchoscope in combination with R-EBUS with or without Guidesheath for lung lesions 2-5 cm.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months||||participants|||Number
2602122|NCT02146326|Secondary|Work Interference With Home Life|"Work-Life Balance was assessed with a six-item measure adapted from an 18-item measure developed by Carlson et al. The measure assesses three types (time-, strain-, and behavior-based) and two directions (work conflict with family and family conflict with work) of balance. The outcome described here is work conflict with family. The measure consists of a series of statements regarding one's work and family situation, to which participants are asked to indicate their level of agreement or disagreement on a 5-point Likert-type scale: 1 (Strongly disagree) to 5 (Strongly agree). The item scores were averaged.~Carlson DS, Kacmar KM, Williams LJ. Construction and initial validation of a multidimensional measure of work-family conflict. Journal of Vocational Behavior. 2000;56(2):249-276."|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602123|NCT02146326|Secondary|Turnover Intentions-Likely to Leave|"This is the second of two questions in which staff were asked about turnover intentions. Staff were asked, How likely are you to leave your job in the next six months? Scale: 1 (Not likely at all), 2 (Not very likely), 3 (Somewhat likely), 4 (Very likely)"|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602124|NCT02146326|Secondary|Turnover Intentions-Considered Leaving|"This is the first of two questions in which staff were asked about turnover intentions. Staff were asked, How often have you seriously considered leaving your job in the past six months? Scale: 1 (Never), 2 (Once every few months), 3 (Once a month), 4 (several times a month), 5 (Once a week), 6 (Several times a week)"|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602125|NCT02146326|Secondary|Job Satisfaction|"Job satisfaction was assessed with one item from the Job Diagnostics Survey: Overall, I am satisfied with my job. Scale: 1 (Strongly Disagree) to 7 (Strongly Agree)~Hackman JR, Oldham GR. The Job Diagnostic Survey: An Instrument for the Diagnosis of Jobs and the Evaluation of Job Redesign Projects. 1974."|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602126|NCT02146326|Primary|Maslach Burnout Inventory (MBI): Personal Accomplishment|"Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were ased to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day).~Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996."|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602127|NCT02146326|Primary|Maslach Burnout Inventory (MBI): Depersonalization|"Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were ased to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day).~Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996."|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602128|NCT02146326|Primary|Maslach Burnout Inventory (MBI): Emotional Exhaustion|"Burnout was assessed with the Maslach Burnout Inventory (MBI), a widely-used measure of three components of burnout: emotional exhaustion, depersonalization, and personal accomplishment. The survey contains 22 statements of job-related feelings and staff were asked to read each statement and decide if they ever felt that way about their job. The item scores were averaged. Scale: 0 (Never), 1 (A few times a year or less), 2 (Once a month or less), 3 (A few times a month), 4 (Once a week), 5 (A few times a week), 6 (Every Day).~Maslach C, Jackson, S. E., Leiter, M. P. Maslach Burnout Inventory Manual. 3 ed. Palo Alto, California: Consulting Psychologists Press; 1996."|Measured with staff at baseline, 3 months, 6 months, and 12 months|The number analyzed at each time point differs from the overall number enrolled due to participant drop out and/or missing data.|||units on a scale||Standard Deviation|Mean
2602129|NCT02146274|Secondary|Functional Status|Euro-QOL ver. 5D-3L (EQ 5D-3L) EQ-5D-3L Five level version of the Euro-QOL. Index Value ranging from 0-1.0 Higher scores indicate better functioning|6 months after enrollment|Comparing functional status of ischemic stroke patients who are and are not taking an antidepressant 6 months post enrollment|||score on scale||Inter-Quartile Range|Median
2602130|NCT02146274|Primary|Depression|Patient Health Questionnaire - 2 Item (PHQ-2) Higher score suggests more depression; range of 0-6. A score of two or higher suggests a diagnosis of major depression.|6 months after enrollment||||units on a scale||Standard Deviation|Mean
2602131|NCT02146248|Other Pre-specified|Number of Participants With Bilateral Tubal Patency as Assessed by HSG -- Post DMPA Add Back COC HSG||HSG on OC after DMPA||||Participants|||Count of Participants
2602132|NCT02146248|Other Pre-specified|Number of Participants With Bilateral Tubal Patency as Assessed by HSG - DMPA HSG|HSG during DMPA treatment|HSG on DMPA||||Participants|||Count of Participants
2602133|NCT02146248|Other Pre-specified|Number of Participants With Bilateral Tubal Patency as Assessed by HSG - OC HSG|HSG during OC treatment|HSG on OC||||Participants|||Count of Participants
2602134|NCT02146248|Primary|Number of Participants With Bilateral Tubal Patency as Assessed by HSG - Luteal|Assessment of patency at luteal phase exam|luteal phase HSG||||Participants|||Count of Participants
2602135|NCT02146248|Primary|Number of Participants With Bilateral Tubal Patency as Assessed by HSG-follicular|Assessment of patency at follicular phase exam|follicular phase HSG||||Participants|||Count of Participants
2602138|NCT02146105|Secondary|Change in Cardiovascular Fitness|Cardiovascular fitness is assessed using a sub maximal oxygen consumption cycle ergometer test. Heart rate is monitored using a Polar Heart Rate monitor and the test is terminated upon one of two conditions: a) volitional fatigue, or b) within 10 beats of 85% of the age-predicted maximum heart rate is achieved. Values are recorded in mL/kg/min.|Week 1 and Week 13|||||||
2602139|NCT02146105|Secondary|Change in Subjective Scales|The Centre of Epidemiologic Studies Depression Scale (19-items), the Athens Insomnia Scale (8-items), and the Perceived Stress Scale (10-items) will be given to the participants to gather information on feelings of depression, sleeping patterns, and perceived stress, respectively.|Week 1 and Week 13|||||||
2602140|NCT02146105|Secondary|Change in Stair Ascent and Descent|Participants are asked to climb a standard flight of 9 stairs as quickly and safely as possible without compromising safety. Stair ascent and descent are assessed individually. Time to climb the stairs are recorded (in seconds) and averaged over two trials.|Week 1 and Week 13|||||||
2602141|NCT02146105|Secondary|Change in Timed Up and Go (TUG)|Participants are asked to raise from a standard chair, walk forward 3-metres until an orange cone is reached, walk around the cone, then walk back to the chair and sit down. The test is to be completed as quickly and safely as possible without running. The trial is repeated a second time and the quickest time (in seconds) is recorded.|Week 1 and Week 13|||||||
2602142|NCT02146105|Secondary|Change in 30-second Chair Stand|Participants are asked to cross their arms over their chest and rise and sit back down in a chair as many times as possible in 30 seconds.|Week 1 and Week 13|||||||
2602143|NCT02146105|Secondary|Change in Six Minute Walk Test (6MWT)|Participants are asked to walk as far as possible for a total of six minutes at a self-selected pace in an obstruction-free rectangular hallway. Distance traveled is recorded in metres (m).|Week 1 and Week 13|||||||
2602144|NCT02146105|Primary|Change in Knee Pain|Knee pain is assessed subjectively via the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaires.|Week 1 and Week 13|||||||
2602145|NCT02146105|Primary|Change in Knee Extensor Torque|Knee extensor torque (Newton*meter) is calculated on a Biodex dynamometer using an isometric protocol. Trials are completed as a voluntary maximum effort.|Week 1 and Week 13||||Nm||Standard Deviation|Mean
2602146|NCT02146001|Secondary|Change in Objectively-monitored Moderate-to-vigorous Physical Activity|Subjects will wear a BodyMedia SenseWearPro armband for 7 days during all waking hours at baseline and 12 weeks (same as for the primary outcome of sedentary behavior). This multi-sensor armband will give an estimate of time spent in moderate-to-vigorous physical activity over a 1 week period.|Change from baseline to 12 weeks||||bouted minutes/week||Standard Error|Least Squares Mean
2602147|NCT02146001|Secondary|Change in Physical Function (Short Physical Performance Battery [SPPB])|Physical function will be assessed by the Short Physical Performance Battery including a chair stand test (timed test to stand up and down 5 times without using hands), a 4-meter walk test for gait speed, and a standing balance test. Standard scoring of the SPPB was used where each test contributes up to 4 points x 3 tests and the score can, therefore, range from 0 (worst) to 12 (best).|Change from baseline to 12 weeks||||points||Standard Error|Mean
2602148|NCT02146001|Primary|Change in Objectively Monitored Sedentary Behavior|Subjects will wear a BodyMedia SenseWearPro armband for 7 days during all waking hours at baseline and 12 weeks. This multi-sensor armband will give an estimate of time spent in sedentary behavior over a 1 week period. Sedentary time will be averaged across days and reported as hours per day.|Change from baseline to 12 weeks||||hours/day||Standard Error|Least Squares Mean
2602149|NCT02145754|Primary|Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative)|number of erythema migrans skin samples with Borrelia Burgdorferi sensu lato detected by Microscopy in Dark Field|weekly examination during 9 weeks of cultivating for individual specimen|Each participant provided two skin samples for analysis, one sample was cultivated in MKP, the other in BSK-H media.|||culture-positive skin samples|||Number
2602150|NCT02145676|Secondary|Change From Baseline in the Self-Care Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)|The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The self-care domain was calculated based on the average of 4 questions.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
2602151|NCT02145676|Secondary|Change From Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)|The SIA-UL asks the patient to assess the impact of upper limb spasticity his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The showering/bathing domain was based on a single question.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
2602152|NCT02145676|Secondary|Change From Baseline in the Dressing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)|The SIA-UL asks the patient to assess the impact of upper limb spasticity in his/her daily life on a 19-item scale. The scale covers impacts on activities of dressing, showering/bathing, and self-care. The SIA score ranged from 0 (not at all difficult) to 4 (extremely difficult) for each question. The dressing domain was calculated based on the average of 2 questions.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
2602171|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CHD Death or MI Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of CHD death or MI through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602172|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CHD Death, MI or SRI-UR Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of CHD death, MI or SRI-UR through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602153|NCT02145676|Secondary|Change From Baseline in Pain on an 11-Point Scale|"The patient is asked to select a number that best describes his/her pain in the treated areas of the study limb on an 11-point scale from 0 = no pain to 10 = pain as bad as can be imagined. Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score >0 are included in the analyses. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening."|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
2602154|NCT02145676|Secondary|Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale|The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the shoulder adductors by passively moving the shoulder adductor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
2602155|NCT02145676|Primary|Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale|The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the elbow flexors by passively moving the elbow flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
2602156|NCT02145468|Secondary|Number of Participants With First Occurrence of Any Unplanned Coronary Revascularization Through to Week 12 and Week 24|Number of participants with first occurrence of any unplanned coronary revascularization through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602157|NCT02145468|Secondary|Number of Participants With First Occurrence of Hospitalization for HF Through to Week 12 and Week 24|Number of participants with first occurrence of hospitalization for HF through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602158|NCT02145468|Secondary|Number of Participants With First Occurrence of Stroke (Fatal and Non-fatal) Events Through to Week 12 and Week 24|Number of participants with first occurrence of stroke (fatal and non-fatal) events through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602159|NCT02145468|Secondary|Number of Participants With First Occurrence of SRI-UR Events Through to Week 12 and Week 24|Number of participants with first occurrence of SRI-UR events through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602160|NCT02145468|Secondary|Number of Participants With First Occurrence of Type I (Spontaneous) MI Events Through to Week 12 and Week 24|Number of participants with first occurrence of type I (spontaneous) MI events through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602161|NCT02145468|Secondary|Number of Participants With First Occurrence of Myocardial Infarction (Fatal and Non-fatal) Events Through to Week 12 and Week 24|Number of participants with first occurrence of myocardial infarction (fatal and non-fatal) events through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602162|NCT02145468|Secondary|Number of Participants With CHD Death Events Through to Week 12 and Week 24|Number of participants with CHD death events through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602163|NCT02145468|Secondary|Number of Participants With CV Death Events Through to Week 12 and Week 24|Number of participants with CV death events through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602164|NCT02145468|Secondary|Number of Participants With All-cause Mortality Through to Week 12 and Week 24|Number of participants with all-cause mortality through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602165|NCT02145468|Secondary|Number of Participants Re-hospitalized Within 30 Days of Discharge|Participants who had a death or re-hospitalization within 30 days of discharge, plus participants who were never discharged from the initial hospitalization were included.|Within up to 30 days of post discharge|ITT Population|||Participants|||Number
2602166|NCT02145468|Secondary|Number of Participants With First Occurrence of Definite or Probable Stent Thrombosis Through to Week 12 and Week 24|Number of participants with first occurrence of definite or probable stent thrombosis through to Week 12 and Week 24 are presented. Participants receiving stent prior to randomization or during the study prior to Week 12 were included.|Week 12, Week 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, in the category titles).|||Participants|||Number
2602167|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CV Death or Type I (Spontaneous) MI Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of CV death or type I (spontaneous) MI through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602168|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CV Death, Type I (Spontaneous) MI or SRI-UR Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of CV death, type I (spontaneous) MI or SRI-UR through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602169|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of All-cause Death or MI Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of all-cause death or MI through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602720|NCT02139137|Secondary|Change in Depression: Beck Depression Inventory|Scale Range: 0-63; higher scores indicate greater symptom severity|Baseline, Week 4||||units on a scale||Standard Deviation|Mean
2602173|NCT02145468|Secondary|Number of Participants With First Occurrence of the Expanded Composite of CV Death, MI, SRI-UR, Stroke or Hospitalization for HF Through to Week 12 and Week 24|Number of participants with first occurrence of the expanded composite of CV death, MI, SRI-UR, stroke or hospitalization for HF through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602174|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CV Death, MI or Stroke Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of CV death, MI or stroke through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602175|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CV Death or Hospitalization for HF Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of CV death or hospitalization for HF through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602176|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of Coronary Events Defined as CHD Death, MI, SRI-UR or Any Unplanned Coronary Artery Revascularization Through to Week 12 and Week 24|Number of participants with first occurrence of the composite of coronary events defined as coronary heart disease (CHD) death, MI, SRI-UR or any unplanned coronary artery revascularization through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602177|NCT02145468|Secondary|Number of Participants With First Occurrence of the Expanded Composite of Arterial CV Events Defined as CV Death, MI, SRI-UR or Stroke Through to Week 12 and Week 24|Number of participants with first occurrence of the expanded composite of arterial CV events defined as CV death, MI, SRI-UR or stroke through to Week 12 and Week 24 are presented.|Week 12, Week 24|ITT Population|||Participants|||Number
2602178|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CV Death, MI or Hospitalization for Heart Failure (HF) up to Week 12 and Week 24.|Number of participants with first occurrence of the composite of CV death, MI or hospitalization for HF up to Week 12 and Week 24 are presented.|Week 12 and Week 24|ITT Population|||Participants|||Number
2602179|NCT02145468|Secondary|Number of Participants With First Occurrence of the Composite of CV Death or MI up to Week 12 and Week 24|Week 12 results are considered the principal secondary endpoint. Number of participants with first occurrence of the composite of CV death or MI up to Week 12 and Week 24 are summarized.|Week 12 and Week 24|ITT Population|||Participants|||Number
2602180|NCT02145468|Secondary|Number of Participants With First Occurrence of MACE Through Week 24|Number of participants with first occurrence of MACE through Week 24 including CV death, MI or SRI-UR are presented. Death for which the CEC or investigator were unable to establish cause were analyzed as CV deaths.|Up to Week 24|ITT Population.|||Participants|||Number
2602181|NCT02145468|Primary|Number of Participants With First Occurrence of Major Adverse Cardiovascular Events (MACE) Through Week 12|The primary efficacy endpoint is the composite measure of adjudicated MACE that includes the time to first occurrence of CV death (death due to a cardiovascular cause), MI or SRI-UR (Severe Recurrent Ischemia requiring Urgent coronary artery Revascularization). Death for which the Clinical Events Committee (CEC) or investigator were unable to establish cause were analyzed as CV deaths.|Up to 12 weeks|Intent-To-Treat (ITT) Population. ITT population comprised of all randomized participants.|||Participants|||Number
2602182|NCT02145429|Secondary|World Health Organization Disability Assessment Schedule (WHODAS-II) Scores|Assessment instrument for health and disability or functional status. Scores on the World Health Organization Disability Assessment Schedule (WHODAS 2.0) range from 12 to 60; a higher score indicated greater disability.|One year||||score on a scale||Standard Deviation|Mean
2602183|NCT02145429|Primary|General Health Questionnaire (GHQ) Scores|Levels of depressive and anxiety symptoms. Scores on the General Health Questionnaire (GHQ-12) range from 0 to 12; a higher score indicated greater symptoms for depression and anxiety|One year||||score on a scale||Standard Deviation|Mean
2602184|NCT02145429|Primary|Percent of Participants Who Develop Major Depression and Anxiety Disorders|Cumulative incidence of episodes of major depression and anxiety disorders over a 12-month period measured by MINI|One year||||Participants|||Count of Participants
2602185|NCT02145403|Secondary|Cumulative Incidence of Non-relapse Mortality|The cumulative incidence of non-relapse mortality|Up to 3 years|||||||
2602186|NCT02145403|Secondary|Cumulative Incidence of Chronic GVHD|The cumulative incidence of chronic Graft Versus Host Disease (GVHD)|Up to 3 years|||||||
2602187|NCT02145403|Secondary|Cumulative Incidence of Acute GVHD|The cumulative incidence of acute Graft Versus Host Disease (GVHD)|Up to 3 years|||||||
2602188|NCT02145403|Secondary|Number of Regimen Related Toxicities (RRTs)|An RTT is defined as an adverse event (AE) that occurs within +37 days after transplant or 30 days after the last dose of carfilzomib (day +7), and is considered to be a direct consequence and a related event as a result of the combination of conditioning chemotherapy, GVHD prophylaxis regimen and carfilzomib.|Up to 30 days post treatment|Subjects who have received at least one dose of carfilzomib were evaluable for toxicities|||Regimen related toxicities|||Number
2602189|NCT02145403|Secondary|Kaplan-Meier Estimate for Overall Survival Time|The time from day 0 to the day of death from any cause.|Up to 3 years|||||||
2602190|NCT02145403|Secondary|Kaplan-Meier Estimate for Progression/Relapse-free Survival Time|Time from day 0 to the date of the first progression/relapse.|Up to 3 years|||||||
2602191|NCT02145403|Primary|"Phase II: Kaplan-Meier Estimate of the Percentage of Patients Who Are Alive and Have Not Developed Any Event"|"Kaplan-Meier estimate of the percentage of patients who are alive and have not developed relapse/progression of primary disease or clinical grade III-IV acute graft-versus- host disease (GVHD) or chronic GVHD requiring systemic treatment. Subjects who receive all 4 doses of carfilzomib at the maximum tolerated dose level will be considered evaluable for endpoint analysis."|1 year|Subjects who have received all 4 doses of carfilzomib at the maximum tolerated dose (MTD) level (dose level 3, 36 mg/m^2): 39 subjects total. Note: three subjects who completed 4 doses of carfilzomib at the MTD during the phase 1 portion of the study were included in phase 2 analysis of the primary outcome measure.|||percentage of participants||95% Confidence Interval|Number
2602208|NCT02145299|Primary|Technical Success|Technical success, defined as the ability to facilitate complete intraluminal crossing of a CTO into the true distal lumen with a TruePath or a CROSSER device and/or any subsequent conventional guidewire, as confirmed by IVUS imaging|Day of operation||||percentage of participants|||Number
2602192|NCT02145390|Other Pre-specified|Identification of New Predictive and Prognostic Biomarkers for Response to Neoadjuvant Chemotherapy, and Bladder Preservation.|To perform exploratory molecular analysis to identify new predictive and prognostic biomarkers for response to neoadjuvant chemotherapy, and bladder preservation. Blood, urine and tumor tissue for muscle invasive bladder cancer. Blood, urine and tumor tissue will be collected pre and post-neoadjuvant chemotherapy, post-cystectomy or chemoradiation, and at any time point of distant metastases.|Up to 1 year Post-Treatment, About 2 years|A minimum of 35 evaluable participants were required for the analysis of this outcome measure. Fewer than 35 participants were enrolled therefore data were not analyzed.||||||
2602193|NCT02145390|Other Pre-specified|Evaluation of Known Predictive and Prognostics Biomarkers for Complete Response to Neoadjuvant Chemotherapy and Bladder Preservation.|To evaluate known predictive and prognostic biomarkers for complete response to neoadjuvant chemotherapy and bladder preservation. Blood, urine and tumor tissue will be collected pre- and post-neoadjuvant chemotherapy, post-cystectomy or chemoradiation, and at any time point of distant metastases.|Up to 1 year Post-Treatment, About 2 years|A minimum of 35 evaluable participants were required for the analysis of this outcome measure. Fewer than 35 participants were enrolled therefore data were not analyzed.||||||
2602194|NCT02145390|Secondary|Rate of Overall Survival in Study Participants|Rate of Overall Survival in Study Participants. Overall survival (OS) is defined as the time elapsed from the start of neoadjuvant chemotherapy until death. Surviving patients (including patients lost to follow up) will be censored at the date of last contact.|Up to 3 years|A minimum of 35 evaluable participants were required for the analysis of this outcome measure. Fewer than 35 participants were enrolled therefore data were not analyzed.||||||
2602195|NCT02145390|Secondary|Rate of Acute and Late Grade 2 or Higher Treatment-Related GU, GI and Hematologic Toxicity.|The rate of acute and late grade 2 or higher (CTCAE v4.0) treatment-related genitourinary (GU), gastrointestinal (GI) and hematologic toxicity of bladder preservation in study participants.|Up to 2 years Post-Treatment|A minimum of 35 evaluable participants were required for the analysis of this outcome measure. Fewer than 35 participants were enrolled therefore data were not analyzed.||||||
2602196|NCT02145390|Secondary|Rate of Failure-Free Survival (FFS) at Two Years|The two year rate of failure free survival (FFS) in study participants. This will include locoregional recurrence, and distant metastases. FFS is defined as absence of any failures (locoregional, distant metastasis, and death) during the time elapsed from the start of neoadjuvant chemotherapy to the date of documented failure events or radical cystectomy.|2 Years|A minimum of 35 evaluable participants were required for the analysis of this outcome measure. Fewer than 35 participants were enrolled therefore data were not analyzed.||||||
2602197|NCT02145390|Primary|Rate of Failure-Free Survival With Intact Bladder (FFSIB) in Study Participants|Rate of failure free survival with intact bladder (FFSIB) at two years in subjects undergoing bladder preservation. FFSIB is defined by the absence of any failures (locoregional, distant metastasis, and death) and bladder preservation (no radical cystectomy for any causes) after definitive chemoradiation. FFSIB is defined as the time elapsed from the start of neoadjuvant chemotherapy to the date of documented failure events or radical cystectomy. For failure-free patients (without failure events and no radical cystectomy), FFSIB will be censored at the last date of documented failure-free bladder preservation (FFBP) status.|2 years|A minimum of 35 evaluable participants were required for the analysis of this outcome measure. Fewer than 35 participants were enrolled therefore data were not analyzed.||||||
2602198|NCT02145299|Secondary|Angiographic Perforation Classification and Rate|"Evaluated in-hospital. The occurrence of any extravasation of contrast during the procedure (detected by the physician performing the procedure, or preferentially the Angiographic Core Laboratory) will be tabulated according to the standard Type 1-3 classification. Type 1 - Extraluminal crater without contrast extravasation~Type 2 - Perivascular blush without contrast jet extravasation~Type 3 - Contrast jet extravasation through frank (≥1 mm) perforation"|Day of operation|These data were not fully captured and summarized as the study was terminated.||||||
2602199|NCT02145299|Secondary|Target Vessel Revascularization|A repeat revascularization procedure (percutaneous or surgical) of the index procedure target vessel. TVR is classified as clinically-driven if the repeat intervention is driven by clinical findings (ischemic symptoms).|30 days post operation||||percentage of participants|||Number
2602200|NCT02145299|Secondary|Ankle-brachial Index (ABI)|The ratio of systolic blood pressure at the ankle to systolic blood pressure in the arm|baseline to 30 days post operation||||ratio||Standard Deviation|Mean
2602201|NCT02145299|Secondary|Target Lesion Revascularization|Describes the percentage of patients that had stented lesions that had to be re-treated due to clinically-driven restenosis.|30 days post operation||||percentage of participants|||Number
2602202|NCT02145299|Secondary|Index Limb Amputation|Need for limb amputation|Day of Operation through 30 days post operation||||participants|||Number
2602203|NCT02145299|Secondary|Walking Capacity|"Change in walking capacity from baseline to 30 days, measured by the Walking Impairment Questionnaire. The questionaire is a subjective measure of patient-perceived walking performance developed for individuals with peripheral arterial disease. Used to evaluate the change in walking capacity study endpoint."|Baseline and 30 days post operation|These data were not fully captured and summarized as the study was terminated.||||||
2602204|NCT02145299|Secondary|Symptomatic Improvement|Symptomatic improvement, as assessed by change in Rutherford Class from baseline to 30 days|Baseline, and 30 days post operation||||percentage of participants|||Number
2602205|NCT02145299|Secondary|Clinical Success|Clinical Success defined as procedure success in the absence of in-hospital all-cause death, index limb amputation above the ankle, and TLR.|Day of operation|These data were not fully captured and summarized as the study was terminated.||||||
2602206|NCT02145299|Secondary|Procedural Success|Procedural success, defined as technical success and (1) residual stenosis <50% in the treated segment (2) and improved distal flow by angiography following the procedure|Day of operation|Due to early study termination for reason unrelated to safety, rather enrollment challenges, part the Procedural Success definition required % residual stenosis which was going to be a Core Laboratory assessment to eliminate bias and maintain consistency in the analysis. With only 8 subjects enrolled, laboratory analysis was not undertaken.||||||
2602207|NCT02145299|Primary|In-hospital Safety|In-hospital safety, defined as a composite of all-cause death, index limb amputation above the ankle, and target lesion revascularization (TLR)|Operation through 30 day follow up||||percentage of participants|||Number
2602209|NCT02145247|Primary|Percent Change of 17-OHP Levels From Baseline|"On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.~Blood samples will be obtained before and after r-hCG adminstration"|before and 24 hours after adminisration of r-hCG|Normal adult women and adult women with PCOS|||percent change||Standard Error|Mean
2602210|NCT02145182|Secondary|Percentage Of Participants With Rejection-free Graft Survival|Graft survival was defined as not having biopsy-proven acute rejection per Banff criteria, graft loss, or participant death. Participants who did not experience graft loss or death were censored at 365 days or the day they withdrew, whichever came first. There were no time-specific protocol mandated biopsies. Kidney biopsy would have been performed for cause at the discretion of the Investigator to assess poor graft function and would have been obtained prior to initiating treatment of suspected allograft rejection. Only summaries of Kaplan-Meier estimates of graft survival at Week 26 (Month 6) and Week 52 (Month 12) are reported.|Week 26 and 52 post transplantation|Full Analysis Set: all participants who were randomized to treatment and received a deceased donor kidney transplant and at least 1 dose of study drug (placebo or eculizumab). Eculizumab participants censored: Month 6 = 7; Month 12 = 132. Placebo participants censored: Month 6 = 2; Month 12 = 128.|||percentage of participants||95% Confidence Interval|Number
2602211|NCT02145182|Secondary|Estimated Glomerular Filtration Rate (eGFR)|The eGFR was calculated by using the Modification of Diet in Renal Disease 7 equation at Day 28 post transplantation. The equation requires serum creatinine, age, ethnicity, gender, blood urea nitrogen, and albumin. The eGFR was calculated retrospectively from participant demographics and laboratory chemistries and is reported in mL/min/square meter (m^2).|Day 28 post transplantation|Safety Set: all participants who received at least 1 dose of study drug (placebo or eculizumab) and made the Day 28 visit.|||mL/min/1.73 m^2||Standard Deviation|Mean
2602212|NCT02145182|Secondary|Percentage Of Participants Who Required Dialysis Post Transplantation|The need for dialysis was assessed by evaluation of renal function; this included urine volume, blood urea nitrogen, serum creatinine, and, starting on Day 2, the creatinine reduction ratio. Blood and urine samples were collected, but because the study failed to demonstrate a treatment effect and the program subsequently lost funding, the collected data from the samples could not be analyzed to generate summary level data. As such, the data set for this secondary outcome measure cannot be summarized.|First 30 days post transplantation|Full Analysis Set: all participants who were randomized to treatment and received a deceased donor kidney transplant and at least 1 dose of study drug (placebo or eculizumab). Because the study failed to demonstrate a treatment effect and the program subsequently lost funding, collected data could not be analyzed to generate summary level data.||||||
2602213|NCT02145182|Secondary|Percentage Of Participants With DGF, Functional DGF, And Immediate Graft Function|DGF was defined as a requirement for dialysis for any reason in the first 7 days post transplantation; functional DGF was defined as no need for dialysis during the first 7 days post transplantation and either (1) a <70% reduction in serum creatinine during the first 7 days post transplantation, or (2) failure of serum creatinine to decrease by at least 10% daily on 3 consecutive days, both measured during the first 7 days post transplantation. Blood and urine samples were collected, but because the study failed to demonstrate a treatment effect and the program subsequently lost funding, the collected data from the samples could not be analyzed to generate summary level data. As such, the data set for this secondary outcome measure cannot be summarized.|First 7 days post transplantation|Full Analysis Set: all participants who were randomized to treatment and received a deceased donor kidney transplant and at least 1 dose of study drug (placebo or eculizumab). Because the study failed to demonstrate a treatment effect and the program subsequently lost funding, collected data could not be analyzed to generate summary level data.||||||
2602214|NCT02145182|Primary|Percentage Of Participants With Delayed Graft Function (DGF) In The First Seven Days Post-transplant|Results are reported for the DGF composite endpoint, defined as the occurrence of DGF (dialysis for any reason in the first 7 days post transplantation), graft loss, death, or loss to follow-up (including discontinuation) in the first 7 days post transplantation and for each item of the composite endpoint. Loss to follow-up included withdrawal due to any reason other than death. The sum of the counts in the events that make up the DGF composite may be greater than the composite count, because a participant who experienced multiple events was only counted once in the composite.|First 7 days post transplantation|Full Analysis Set: all participants who were randomized to treatment and received a deceased donor kidney transplant and at least 1 dose of study drug (placebo or eculizumab).|||percentage of participants|||Number
2602215|NCT02145169|Secondary|Length of ED Stay|Length of ED stay|At primary ED visit|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2602216|NCT02145169|Secondary|Nurse Procedure Satisfaction Score|Nurse procedure satisfaction survey responses|At procedure completion|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2602217|NCT02145169|Secondary|Patient Procedure Satisfaction Score|Patient procedure satisfaction survey responses|At procedure completion|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2602218|NCT02145169|Secondary|Physician Procedure Satisfaction Score|Physician procedure satisfaction survey responses|At procedure completion|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2602219|NCT02145169|Secondary|Total Time of Nitrous Use|Total elapsed time of nitrous use|At primary ED visit when the patient is undergoing the intervention|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2602220|NCT02145169|Secondary|Total Ketamine Dose|Total Ketamine dose|At primary ED visit when the patient is undergoing the intervention|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2602221|NCT02145169|Secondary|Patient Recall of Procedure|Patient recall of procedure|At primary ED visit when the patient is undergoing the intervention|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2602222|NCT02145169|Secondary|Level of Sedation|Ramsay sedation score|At primary ED visit when the patient is undergoing the intervention|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2602258|NCT02144701|Primary|Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring||1 month||||Participants|||Count of Participants
2602223|NCT02145169|Secondary|Physician Interventions|verbal or physical stimulation, airway repositioning, additional oxygen, positive pressure ventilation, endotracheal intubation|At primary ED visit when the patient is undergoing the intervention|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2602224|NCT02145169|Secondary|Vitals|heart rate, respiratory rate, peripheral SaO2|At primary ED visit when the patient is undergoing the intervention|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2602225|NCT02145169|Secondary|Physiologic Measure|SpO2 measured q 5 seconds|At primary ED visit when the patient is undergoing the intervention|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2602226|NCT02145169|Secondary|Physiologic Measure|ETCO2 measured q 5 seconds|At primary ED visit when the patient is undergoing the intervention|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2602227|NCT02145169|Primary|Emergence Reaction|Presence or absence of emergence reaction|At primary ED visit when the patient is undergoing the intervention|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2602228|NCT02145156|Primary|Number of Adolescents Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|||participants|||Number
2602229|NCT02145156|Primary|Number of Adolescents Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start|This outcome describes the number of adolescent participants between the ages of 9-17 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|||participants|||Number
2602230|NCT02145156|Primary|Number of Adolescents, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|||participants|||Number
2602231|NCT02145156|Primary|Number of Adolescents Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline and did not complete the vaccine series during the study period.|||participants|||Number
2602232|NCT02145156|Primary|Number of Adolescents Who Initiated the HPV Vaccine Series During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline.|||participants|||Number
2602233|NCT02145156|Primary|Number of Adolescents Who Received Any Dose of the HPV Vaccine During the Study Period|This outcome describes the number of adolescent participants between the ages of 9-17 who received any dose of the HPV vaccine during the study period.|16 months|Includes adolescents in the sample who could be matched to vaccination data and had not received all 3 doses of the HPV vaccine prior to baseline.|||participants|||Number
2602234|NCT02145156|Primary|Number of Young Adults Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|||participants|||Number
2602235|NCT02145156|Primary|Number of Young Adults Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start|This outcome describes the number of young adult participants between the ages of 18-26 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|||participants|||Number
2602236|NCT02145156|Primary|Number of Young Adults, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.|||participants|||Number
2602259|NCT02144701|Primary|Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring||Baseline||||Participants|||Count of Participants
2603260|NCT02134119|Secondary|Hematological Measures - Red Blood Cells|as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days||||M/uL||Standard Deviation|Mean
2602237|NCT02145156|Primary|Number of Young Adults Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline and did not complete the vaccine series during the study period.|||participants|||Number
2602238|NCT02145156|Primary|Number of Young Adults Who Initiated the HPV Vaccine Series During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline.|||participants|||Number
2602239|NCT02145156|Primary|Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period|This outcome describes the number of young adult participants between the ages of 18-26 who received any dose of the HPV vaccine during the study period.|16 months|Includes young adults in the sample who could be matched to vaccination data and had not received all 3 doses of the HPV vaccine prior to baseline.|||participants|||Number
2602240|NCT02145039|Secondary|Number of Patients Experiencing Transplant Related Mortality (TRM)||6 months||||Participants|||Count of Participants
2602241|NCT02145039|Secondary|Number of Patients Experiencing Chronic Graft-versus-host Disease by 1 Year||1 year|Data were not collected for this Outcome Measure as both participants died by the 6 month time point||||||
2602242|NCT02145039|Secondary|Number of Patients Experiencing Acute Graft-versus-host Disease by 100 Days||100 days||||Participants|||Count of Participants
2602243|NCT02145039|Secondary|Number of Patients With Chimerism|Number of patients with chimerism at day 100, 6 months and 1 year|100 days|Chimerism at 6 months and 1 year not evaluated|||Participants|||Count of Participants
2602244|NCT02145039|Secondary|Number of Patients With Hematopoietic Engraftment|Engraftment is defined as absolute neutrophil count (ANC) ≥ 5 X 10^8/L for 3 consecutive measurements.|42 days||||Participants|||Count of Participants
2602245|NCT02145039|Primary|2 Year Survival|Percentage of patients that survive 2 years post-transplant|2 years||||Participants|||Count of Participants
2602246|NCT02145026|Secondary|Percentage of Participants With Adverse Events||From signing of informed consent up to 4 weeks after last dose (up to 18 weeks)|The safety population included all participants that received at least one dose of study medication.|||Percentage of Participants|||Number
2602247|NCT02145026|Secondary|Percentage of Participants With Neutrophil Response (in Participants With Pre-Treatment Neutrophil <1.0*10^9 Per Liter) at Week 12 as Assessed by IWG 2006 Response Criteria|Neutrophil response according to IWG 2006 criteria was defined as at least 100% increase and an absolute increase of >0.5x10^9/L.|Week 12|Efficacy analysis was performed on the intent-to-treat (ITT) population, defined as all enrolled participants who received at least one dose of study medication.|||Percentage of Participants|||Number
2602248|NCT02145026|Secondary|Percentage of Participants With Platelet Response (in Participants With Pre-Treatment Platelets <100*10^9 Per Liter) at Week 12 as Assessed by IWG 2006 Response Criteria|Platelet response according to IWG 2006 criteria was defined as an absolute increase of >/= 30x10^9/L for participants starting with >20x10^9/L platelets.|Week 12|Efficacy analysis was performed on the intent-to-treat (ITT) population, defined as all enrolled participants who received at least one dose of study medication.|||Percentage of Participants|||Number
2602249|NCT02145026|Primary|Proportion of Participants Achieving Erythroid Response at Week 12 as Assessed by International Working Group (IWG) 2006 Response Criteria|Erythroid response at Week 12 according to IWG 2006 criteria was defined as a hemoglobin (Hb) increase of >/= 1.5 grams/deciliter (g/dL), and a reduction of units of red blood cell (RBC) transfusions by at least 4 transfusions/8 weeks compared with the pre-treatment transfusion number in the previous 8 weeks. Only RBC transfusions given for an Hb of </= 9.0 g/dL pre-treatment were counted in the RBC transfusion response evaluation.|Week 12|Efficacy analysis was performed on the intent-to-treat (ITT) population, defined as all enrolled participants who received at least one dose of study medication.|||Participants|||Count of Participants
2602250|NCT02144714|Secondary|Time to Cmax (Tmax)|pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose|pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose|Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.|||h||Standard Deviation|Mean
2602251|NCT02144714|Primary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)|pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose|0 to 1680 hours post-dose|Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.|||μg·h/mL||Standard Deviation|Mean
2602252|NCT02144714|Primary|Maximum Serum Concentration (Cmax)|pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose|pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose|Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.|||μg/mL||Standard Deviation|Mean
2602253|NCT02144714|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)|pre-dose (0 h) and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 336, 504, 672, 1008, 1344, and 1680 h post-dose|0 to 1680 hours post-dose|Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.|||μg·h/mL||Standard Deviation|Mean
2602254|NCT02144701|Primary|Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring||12 months||||Participants|||Count of Participants
2602255|NCT02144701|Primary|Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring||9 months||||Participants|||Count of Participants
2602256|NCT02144701|Primary|Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring||6 months||||Participants|||Count of Participants
2602257|NCT02144701|Primary|Rate of Grade 1 Upper GI and/or 2-4 Lower GI aGVHD Assessed Using CIBMTR Scoring||3 months||||Participants|||Count of Participants
2602260|NCT02144675|Primary|Inhibition of NF-kB Target Transcripts and/or Inhibition of Drug Efflux in at Least 50% of Patients|The clinical trial will be based on a sequential monitoring so that we will have a 90% confidence that choline magnesium trisalicylate (CMT) based modulation of NF-kB transcriptional targets and/or drug efflux occurs in at least 50% of patients.|24 hours||||Participants|||Count of Participants
2602261|NCT02144610|Post-Hoc|Time to Major Amputation (of the Index Leg) or All-cause Death|The median time to major amputation or death was analyzed over the duration of the study as a post-hoc analysis; all reports of major amputation or death were included in this post hoc analysis, irrespective of pre-defined study windows.|Month 36|Subjects who had a major amputation or died during the study|||Days||Full Range|Median
2602262|NCT02144610|Primary|Changes in the Quality of Life From Baseline Using the EQ-5D-5L Over 18 Months|"The EQ-5D-5L descriptive system covers 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5); death was coded as a worst case.~The EQ-5D-5L health state for each subject, referred to as a 5 digit code that combines 1 level from each of the 5 dimensions, was converted into a single index value using a published weighing system. The index value ranges from -0.109 to 1, where 1 indicates no problems in all 5 dimensions, and is reduced when a patient reports increasing problems.~Summary statistics were provided for baseline and change from baseline by visit and treatment for EQ-5D-5L, including subscore, for subjects who had a non-missing value at both baseline and the specific visit. A two-way ANCOVA with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF."|18 months|The number analyzed in one or more rows differs from overall number analyzed due to early discontinuation.|||score on a scale||Standard Deviation|Mean
2602263|NCT02144610|Primary|Changes in the Quality of Life Using the Vascular Quality of Life Questionnaire (VascuQol) Over 18 Months|"The VascuQol contains 5 domains (pain, symptom, activities, social, and emotional functioning); responses were scored from 0 (lowest QOL, death) to 7 (best QOL, maximum health).~Responses were averaged for composite overall and domain-specific scores, giving equal weight to each question and domain. The composite overall is the average of domain-specific scores.~Responses after revascularization or major amputation were included in the analysis. In the event of death, subjects were scored as 0. For the effect of treatment on individual domains, pain, symptoms, and activities were considered the most important of the 5 domains.~Summary statistics were provided for baseline and change from baseline by visit and treatment for VascuQol, including subscore, for subjects who had a non-missing value at both baseline and the specific visit. A two-way ANCOVA with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF."|18 months|The number analyzed in one or more rows differs from overall number analyzed due to early discontinuation.|||score on a scale||Standard Deviation|Mean
2602264|NCT02144610|Primary|Hemodynamic Measurements - Mean Change From Baseline in TBI of Index Leg|Summary statistics were provided for baseline and change from baseline for calculated TBI by visit and treatment (only subjects with non-missing baseline and visit values). A two-way analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF.|18 months|The number analyzed in one or more rows differs from overall number analyzed due to early discontinuation.|||ratio||Standard Deviation|Mean
2602265|NCT02144610|Primary|Hemodynamic Measurements - Mean Change From Baseline in ABI of Index Leg|Summary statistics were provided for baseline and change from baseline for calculated ABI by visit and treatment (only subjects with non-missing baseline and visit values). A two-way analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF.|18 months|The number analyzed in one or more rows differs from overall number analyzed due to early discontinuation.|||ratio||Standard Deviation|Mean
2602266|NCT02144610|Primary|Hemodynamic Measurements - Mean Change From Baseline in Toe Systolic Pressure|Summary statistics were provided for baseline and change from baseline for toe systolic pressure by visit and treatment (only subjects with non-missing baseline and visit values). A two-way analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF.|18 months|The number analyzed in one or more rows differs from overall number analyzed due to early discontinuation.|||mmHg||Standard Deviation|Mean
2602267|NCT02144610|Primary|Hemodynamic Measurements - Mean Change From Baseline in Ankle (Dorsalis Pedis/Posterior Tibial) Systolic Pressure|Summary statistics were provided for baseline and change from baseline for ankle systolic pressure measured at dorsalis pedis and posterior tibial by visit and treatment (only subjects with non-missing baseline and visit values). A two-way analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF.|18 months|The number analyzed in one or more rows differs from overall number analyzed due to early discontinuation.|||mmHg||Standard Deviation|Mean
2602268|NCT02144610|Primary|Hemodynamic Measurements - Mean Change From Baseline in Brachial (Right/Left) Systolic Pressure|Summary statistics were provided for baseline and change from baseline for right/left brachial systolic pressure by visit and treatment (only subjects with non-missing baseline and visit values). A two-way analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF.|18 months|The number analyzed in one or more rows differs from overall number analyzed due to early discontinuation.|||mmHg||Standard Deviation|Mean
2602269|NCT02144610|Primary|VAS Improvement|A table showing the number of subjects with improvement in VAS (≥ 20 mm) by treatment.|18 months||||Participants|||Count of Participants
2602270|NCT02144610|Primary|Ulcer Improvement|A table showing the number of subjects with complete healing of the target ulcer by treatment. Ulcer healing of the largest ulcer on the index limb was assessed clinically by the Principal Investigator by direct visual inspection at each study visit. If the largest ulcer on the index leg was considered completely healed, photographs of the healed ulcer area was captured. If an ulcer healed completely during the study period, the ulcer was re-evaluated 2 weeks later to confirm it has remained healed. Confirmation of complete ulcer healing was made by an outside physician unconnected with the study and nominated for this purpose.|18 months|The number of participants analyzed are those that have an ulcer on the index leg at the time of enrollment (n=11 in HGF plasmid group, n=13 in placebo group).|||Participants|||Count of Participants
2602271|NCT02144610|Primary|Change in Ischemic Rest Pain (in the Index Leg) From Baseline Using a 10 cm Visual Analog Scale (VAS) Scale|"The severity of rest pain (based on the average over previous 7 days) recorded using the 10 cm visual analog scale (VAS).~VAS is a 10-cm line (with score ranges 0 to 10), oriented horizontally; the left end of the line (0 mark) indicates no pain; the right end indicates pain as bad as it can be.~The subject is asked to mark a place on the line corresponding to the average pain intensity experienced in the last 7 days.~The distance along the scale is converted into a numeric reading by measuring the distance of the subjects mark in cm from the beginning of the scale (the 0 mark)."|18 months|The number analyzed in one or more rows differs from overall number analyzed due to early discontinuation.|||score on a scale||Standard Deviation|Mean
2602272|NCT02144610|Primary|Major Amputation or Revascularization (of the Index Leg), All-cause Death, and Incidence of Stroke and Myocardial Infarction (MI)|A frequency table for Day 0 to 6 months, Day 0 to 12 months and Day 0 to 18 months intervals by treatment group; the Fisher's Exact test was used for treatment comparison.|18 months||||Participants|||Count of Participants
2602273|NCT02144519|Secondary|Changes in Nutritional Quality of Snacks|We will assess quality of snacks served at the ASPs in terms of number of fruits and vegetables served per week. These analyses were performed at the ASP level with a sample size of 20 (10 per arm)|Spring of Year 1, Year 2, and Year 3|Direct observation of the number of days per week a fruit or vegetable was served|||Days/Week Fruit/Vegetables served|Afterschool Programs|Standard Deviation|Mean
2602274|NCT02144519|Primary|Change in Percentage of Children Meeting Physical Activity Policy|We will assess the number of children meeting the physical activity policy of 30 minutes or more of moderate-to-vigorous physical activity. The primary physical activity (PA) and sedentary behavior outcome was derived via accelerometry. All children attending an ASP on unannounced measurement days had an opportunity to wear the ActiGraph GT3X+. The accelerometers were distilled using 5-second epochs. When children arrived to a program, they were fitted with an accelerometer and the arrival time was recorded (monitor time on). Before a child departed from a program, research staff removed the belt and recorded the time of departure (monitor time off). Children wore the monitors for their entire attendance at the ASPs. Cutpoint thresholds associated with moderate and vigorous activity were used to distill the PA intensity levels and sedentary behavior. Children were considered to have a valid day of accelerometer data if their total wear time (time off minus time on) was ≥60 minutes.|Spring of Year 1, Year 2, and Year 3|Analysis based on the percentage of children (boys and girls, separately) achieving the 30 min MVPA standard|||Percent children achieving MVPA standard|||Number
2602275|NCT02144337|Primary|Feasibility: Number of Participants With Adverse Events|Number of participants experiencing and/or reporting adverse events.|Participants were followed from baseline to research completion||||number of participants|||Number
2602276|NCT02144337|Secondary|Change in Parental Hypoglycaemia Fear Using the Hypoglycaemia Fear Survey (HFS-Parent)||0 months (baseline) and 6 months (follow-up)|||||||
2602277|NCT02144337|Secondary|Change in Clinical Outcome Measures (Hba1c, Height, Weight)|Data collected as routine clinic procedure and will be used to assess changes in HbA1c and BMI from baseline to follow-up.|0 months (baseline) and 6 months (follow-up)|||||||
2602278|NCT02144337|Secondary|Change in Children's Level of Physical Activity (Measured Subjectively Via Self-report Questionnaire)||0 months (baseline) and 6 months (follow-up)|||||||
2602279|NCT02144337|Secondary|Change in Children's Self-efficacy Using CSAPPA Scale (Children's Self‐Perceptions of Adequacy in and Predilection for Physical Activity)||0 months (baseline) and 6 months (follow-up)|||||||
2602280|NCT02144337|Primary|Feasibility: Rate of Adherence to the Intervention|Attendance at physical activity sessions and completion of activity diary Intervention group only as the Control group were not exposed to any intervention.|Participants were monitored for the duration of the STAK programme (6 weeks)||||percentage of the intervention group|||Number
2602281|NCT02144337|Primary|Feasibility: Response Rate|Number of participants completing outcome measures at T3|Response rate at T3||||Number of participants|||Number
2602282|NCT02144337|Primary|Feasibility: Response Rate|Number of participants completing outcome measures at T2|Response rate at T2||||number of participants|||Number
2602283|NCT02144285|Secondary|Pharmacodynamics: Maximum Change From Baseline in Hemoglobin (Hb) Parameter Profile of LY3113593||Baseline, Day 85|All enrolled participants who received at least one dose of study drug and had baseline and post baseline Hb profile data.|||millimoles per liter of iron (mml/L-Fe)||Standard Deviation|Mean
2602284|NCT02144285|Secondary|Pharmacodynamics: Maximum Absolute Change From Baseline in TSat Parameter Profile of LY3113593||Baseline, Day 85|All enrolled participants who received at least one dose of study drug and had baseline and post baseline Tsat profile data.|||percentage of change||Standard Deviation|Mean
2602285|NCT02144285|Secondary|Pharmacodynamics: Maximum Change From Baseline in Iron Parameter Profile of LY3113593||Baseline, Day 85|All enrolled participants who received at least one dose of study drug and had baseline and post baseline iron profile data.|||micromoles per liter (μmol/L)||Standard Deviation|Mean
2602286|NCT02144285|Secondary|Pharmacokinetics: Absolute Bioavailability of LY3113593 SC Versus IV Based on AUC Ratios||Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85|All enrolled participants who received at least one dose of 150mg LY3113593 study drug.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2602287|NCT02144285|Secondary|Pharmacokinetics: Area Under the Concentration Curve to Infinity (AUC (0-∞)) of LY3113593||Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85|All enrolled participants who received at least one dose of LY3113593 study drug.|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2602288|NCT02144285|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY3113593||Day 1: pre-dose, 30 minutes, 2 hours, 4 hours, 12 hours; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, and 85|All enrolled participants who received at least one dose of LY3113593 study drug.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2602312|NCT02144233|Other Pre-specified|Headache-intensity|Headache intensity in recent months (If any) in a 0-10 numerical pain rating scale with 0=no pain and 10= worst possible pain.|Baseline 3- and 6-Months||||score on a scale||Inter-Quartile Range|Median
2602313|NCT02144233|Secondary|Maximum Unassisted Jaw Opening|Vertical jaw-opening (incisal level) measured using a ruler. Higher values represent a better outcome.|Baseline, 3- and 6-Months||||mm||Standard Deviation|Mean
2602289|NCT02144285|Primary|Number of Participants With One or More Serious Adverse Event (s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline through end of study (Day 85)|All enrolled participants who received at least one dose of study drug.|||Participants|||Count of Participants
2602290|NCT02144259|Other Pre-specified|Contraceptive Satisfaction|"Satisfaction will be measured in response to the question, How satisfied are you with your current birth control method? This question will be asked to the participant at the 6 month follow-up visit. Answer choices that participants could choose from range from Very Good to Very Poor. Good or Very Good responses will be analyzed as having been satisfied with the method."|1 year||||percentage of women satisfied w. method|||Number
2602291|NCT02144259|Secondary|Pregnancy Rate|The secondary outcome variable is pregnancy rate. Pregnancy testing will occur at 3, 6 and 12 months postpartum or at any time that a participant felt that she might be pregnant.|1 year||||number of pregnancies|||Number
2602292|NCT02144259|Primary|Weight|Weight will be measured at 6 months postpartum. Percent weight change will be compared amongst the groups|6 months from postpartum (baseline)||||percent weight lost||Standard Deviation|Mean
2602293|NCT02144233|Other Pre-specified|Protrusive Motion|Magnitude (mm) of protrusive jaw-movement (incisal level) and lateral shift (quantitative, mm; and/or qualitative, left/right), using kinesiography recordings. Higher values represent a better outcome.|Baseline, 6-Months|||||||
2602294|NCT02144233|Other Pre-specified|Patient's Perception of Reduced Movement|Subjective patient's perception of reduced jaw-opening; how many fingers can put between your incisors?. Higher values represent a better outcome.|Baseline, 6-Months|||||||
2602295|NCT02144233|Other Pre-specified|Maximum Comfortable (Without Pain) Jaw Opening|Vertical jaw-opening (incisal level) measured using a ruler.|Baseline, immediate after therapy, 3- and 6-Months|||||||
2602296|NCT02144233|Other Pre-specified|Occlusal Forces/Pressure|Dental or occlusal forces measured using fuji-film method.|Baseline; 6-Months|||||||
2602297|NCT02144233|Other Pre-specified|Periodontal Disease (if Indicated)|Radiographic defect, Probing depth, Clinical attachment level, Tooth mobility Tooth mobility|Baseline, 6-Months|||||||
2602298|NCT02144233|Other Pre-specified|Circulating Biomarkers|Blood levels of Circulating Biomarkers|Baseline, 6-Months|||||||
2602299|NCT02144233|Other Pre-specified|Temporomandibular Disorders Related Impairment|Mandibular Function Impairment Questionnaire (MFIQ)|Baseline, 6-Mo|||||||
2602300|NCT02144233|Other Pre-specified|Pain-dimensions|McGill Pain questionnaire|Baseline, 6-Months|||||||
2602301|NCT02144233|Other Pre-specified|Pain Interference on Daily Activity|"In the past 6 months, how much has facial pain interfered with your daily activities rated on a 0-10 scale where 0 is no interference and 10 is unable to carry on any activities? 0-10 VAS/NRS (0=No interference to 10=Unable to carry on any activities). N.B. Only one item was choose to simplify."|Baseline; 6-Months|Data from two occlusal adjustment and six placebo group participants were not available.|||units on a scale||Standard Deviation|Mean
2602302|NCT02144233|Other Pre-specified|Patient Impression (Improvement)|Patient impression outcome will be reported as Improved Vs. no change.|6-Months|Data from two participants in placebo group that underwent randomization were not available.|||Participants|||Count of Participants
2602303|NCT02144233|Other Pre-specified|Sociodemography|Level of education|Baseline||||Participants|||Count of Participants
2602304|NCT02144233|Other Pre-specified|Credibility (of Participants)|"Confidence of participants in the goodness of treatment.~These items were simplified here to the following single question:~How confident would you be that this treatment would be successful in eliminating your pain and/or limited mouth opening? 0-10 numerical rating scale, with 0=nothing to 10= totally."|Baseline, 6-Months|Data from one participant from each group was lost from baseline, and 2 from the Occlusal adjustment group and 5 from the placebo group at 6-months.|||units on a scale||Standard Deviation|Mean
2602305|NCT02144233|Other Pre-specified|Participant's Awareness With Trial Group Assignment|Physicians and patients are quizzed at the end of the study to determine whether or not they have guessed the therapy involved|Six months||||Participants|||Count of Participants
2602306|NCT02144233|Other Pre-specified|Jaw Asymmetry|Over 1 mm of interincisal midline deviation and inter-arches Angle Classification of the lateral sectors (canines and first molars); it will be assessed during maximal intercuspal position and during jaw retruded contact position|Baseline|||||||
2602307|NCT02144233|Other Pre-specified|Adverse Events|Unexpected Adverse Events (NIH, 2009).|After therapy, 1-Month, 3-Months, 6-Months||||Participants|||Count of Participants
2602308|NCT02144233|Other Pre-specified|Condylar Path Angles|Parasagittal plane condylar path tracings in relation to the Frankfort Horizontal Plane following the Gysi extraoral method.|Baseline||||degrees||Standard Deviation|Mean
2602309|NCT02144233|Other Pre-specified|Lateral Guidance Angles (LG)|The angle between the tangent of the LG tracings and the horizontal Frankfort line, starting from the midsagittal point up 2 mm: using a calibrated Model K7 diagnostic system. Both sides recordings of each patient were measured and considered individually. The mean of both sides of each patient was not used.|Baseline|Note that both sides of each participant was assessed. Recordings from one participant in each group are unavailable.|||degrees|LG|Standard Deviation|Mean
2602310|NCT02144233|Other Pre-specified|Handedness Preference|"Handedness preference assessed using Edinburg inventory:~Left Right~Writing~Drawing~Throwing~Scissors~Toothbrush~Knife (without fork)~Spoon~Broom (upper hand)~Striking Match (match)~Opening box (lid) I Which foot do you prefer to kick with? II Which eye do you use when using only one?"|Baseline||||Participants|||Count of Participants
2602311|NCT02144233|Other Pre-specified|Number of Participants With Neuropathic Pain|Neuropathic pain Questionnaire (DN4). Over 4 scores indicates neuropathic facial pain.|Baseline, 6-Months|Data from 1 placebo group participant at 6-months not available|||Participants|||Count of Participants
2602381|NCT02143310|Primary|Clinical Laboratory Parameters|High density lipoprotein (HDL) cholesterol, change from baseline (BL)|24 months||||mmol/L||95% Confidence Interval|Mean
2602314|NCT02144233|Secondary|Change in Global Severity Index Scores (Symptom Checklist-90-Revised (SCL-90-R))|Mean change in Global Severity Index scores from a self-administered Spanish validated questionaire SCL-90-R. Higher values represent a worse outcome. Range (0-4).|Baseline, 6-Months|Some self administered questionnaire was not adequately covered by the patient.|||score on a scale||Standard Deviation|Mean
2602315|NCT02144233|Secondary|Chewing Side|A consistent chewing side was considered if at lees 5 out of 7 almonds (or at lees 7 of 10 cycles of chewing gum), the participant report to use same side, and same side was used during kinesiography recordings of spontaneous chewing. Any other results lead to alternate chewing allocation.|Baseline and 6-months||||Participants|||Count of Participants
2602316|NCT02144233|Primary|Jaw-pain-Intensity (Affected Side)|Self-reported affected-side pain-intensity across the trial in a 0-10 visual analogue scale (VAS) (0=no pain, 10=worst possible pain). Higher values represent a worse outcome.|Baseline and 6-months||||units on a scale||Inter-Quartile Range|Median
2602317|NCT02144220|Secondary|Percentage of Patients Who Felt That the Recommendations Improved Their Health||6 months||||percentage of participants|||Number
2602318|NCT02144220|Secondary|Feasibility (Descriptive)|Percentage of physician visits where the physician was were satisfied or very satisfied with the virtual visit overall.|6 months||||percentage of visits|||Number
2602319|NCT02144220|Secondary|Acceptability|- The percent of patients participated who stated that they are interested in receiving ongoing care for their PD via telemedicine. (Goal >80%)|6 months||||percentage of participants|||Number
2602320|NCT02144220|Primary|Change in Quality of Life as Measured by the PDQ-39 Assessment Tool|The impact on Quality of life (QoL) as measured by the change in PDQ-39 score from baseline to 6 months. The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month. 5-point ordinal scoring system: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always. Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life.|Baseline and 6 months||||units on a scale||95% Confidence Interval|Number
2602321|NCT02144220|Primary|Feasibility|The percent of telemedicine visits completed as scheduled. (Goal >80%)|6 months||||percentage of visits|||Number
2602322|NCT02144155|Secondary|Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)||28 Weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2602323|NCT02144155|Secondary|Computerized Multiphasic Interactive Neurocognitive DualDisplay TM System (CMINDS®)||28 weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2602324|NCT02144155|Secondary|Clinical Global Impression-Global Improvement (CGI-I)|The CGI-I is a global assessment to evaluate the subject's improvement or worsening from baseline. Scores on the CGI-I scale range from 1 (very much improved) to 7 (very much worse).|28 Weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2602325|NCT02144155|Secondary|Clinical Global Impression-Severity|The CGI-S is used to evaluate changes in overall severity of illness. Scores range from 1 (not at all) to 7 (among the most extremely ill).|28 Weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2602326|NCT02144155|Secondary|Global Assessment of Functioning (GAF)|The GAF considers psychological, social, and occupational functioning on a hypothetical continuum of mental health illness. Scores on the GAF range from 1 (extremely severe) to 100 (superior functioning).|28 weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2602327|NCT02144155|Primary|Change in Total Score in the Positive and Negative Syndrome Scale (PANSS) From Baseline to 28 Weeks|The three subscales of the PANSS include the Positive scale (7 items), the Negative scale (7 items), and the General Psychopathology scale (16 items). The total PANSS score is the sum of all 30 items of which each item is scored on a 1-7 rating system (7 indicating the worst symptoms). The items on the PANSS focus on symptoms that are common in patients with psychotic disorders and include hallucinations, delusions and disorganization as well as mood disturbances.|baseline and 28 weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2602328|NCT02144077|Secondary|Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1)|"Overall cosmetic outcome 12 weeks after last PDT is calculated as difference between 12 weeks after PDT sum score and baseline sum score of all skin quality assessments. Each of the below skin quality characteristics are assessed on a 4-point scale from 0 (none) to 3 (severe) by the investigator at baseline and 12 weeks after last PDT:~Skin surface~Hyperpigmentation~Hypopigmentation~Mottled or irregular pigmentation~Degree of scarring~Atrophy~Cosmetic outcome categories are:~Very good: 12 weeks sum score improved by at least 2 points compared to baseline~Good: 12 weeks sum score improved by 1 point compared to baseline~Satisfactory: 12 weeks sum score identical to the one at baseline~Unsatisfactory: 12 weeks sum score worsened by 1 point compared to baseline~Impaired: 12 weeks sum score worsened by at least 2 points compared to baseline"|12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).|Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.|||Percentage of Patients||95% Confidence Interval|Number
2602329|NCT02144077|Secondary|Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline)|"Overall cosmetic outcome 12 weeks after last PDT is calculated as difference between 12 weeks after PDT sum score and baseline sum score of all skin quality assessments. Each of the below skin quality characteristics are assessed on a 4-point scale from 0 (none) to 3 (severe) by the investigator at baseline and 12 weeks after last PDT:~Skin surface~Hyperpigmentation~Hypopigmentation~Mottled or irregular pigmentation~Degree of scarring~Atrophy~Cosmetic outcome categories are:~Very good: 12 weeks sum score improved by at least 2 points compared to baseline~Good: 12 weeks sum score improved by 1 point compared to baseline~Satisfactory: 12 weeks sum score identical to the one at baseline~Unsatisfactory: 12 weeks sum score worsened by 1 point compared to baseline~Impaired: 12 weeks sum score worsened by at least 2 points compared to baseline"|12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).|Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.|||Percentage of Patients||95% Confidence Interval|Number
2602330|NCT02144077|Secondary|Patient Complete Response 12 Weeks After PDT-2|Patient complete response (complete clearance of all treated lesions) assessed 12 weeks after PDT-2 (first PDT cycle). The PP set is the primary analysis set for the analysis of the secondary endpoint.|12 weeks after PDT-2 (=PDT cycle 1; please note: in this study 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).|Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.|||Percentage of Patients||95% Confidence Interval|Number
2602331|NCT02144077|Secondary|Reduction of Lesion Area 12 Weeks After the Last PDT Compared to Baseline|"Reduction of total lesion area (summation of sizes of all treated lesions) per patient, assessed 12 weeks after the last PDT. The PP set is the primary analysis set for the analysis of the secondary endpoint.~Please note that the high SD for BF-200 ALA is due to a patient who had increased lesion area fom 63 mm² at baseline to 225 mm² 12 weeks after PDT. This lesion area included a lesion that was later confirmed to be benign skin condition (lentigo solaris)."|12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).|Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.|||Percentage of Change||Standard Deviation|Mean
2602332|NCT02144077|Secondary|Lesion Complete Response Assessed 12 Weeks After the Last PDT|Lesion complete response (completely cleared individual lesions) assessed 12 weeks after the last PDT. The indicated values give percentage of overall completely cleared individual lesions. The PP set is the primary analysis set for the analysis of the secondary endpoint.|12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).|Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.|||Percentage of Individual Lesions|individual lesions|95% Confidence Interval|Number
2602333|NCT02144077|Primary|Overall Patient Complete Response Rate Assessed 12 Weeks After the Last PDT|Overall patient complete response rate assessed 12 weeks after the last PDT. The indicated values give the percentage of overall complete responders. An overall complete responder is defined as a patient in whom all treated lesions were cleared. The PP set is the primary analysis set for the analyses of the primary endpoint.|12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).|Per-protocol (PP) analysis set: All patients of the FAS without any major protocol deviations.|||Percentage of Patients||95% Confidence Interval|Number
2602334|NCT02144012|Secondary|Patient-Reported Outcomes: Number of Participants Who Completed the FACT-Taxane Questionnaire|The FACT - Taxane is a self-reported instrument which measures the HRQOL of participants receiving taxane containing chemotherapy. The FACT-Taxane consists of 16 items and was designed to assess the impact of taxane treatment-related symptoms from the participant's perspective.|Days 1 and 8 of Cycles 1 and 2 and on the first day of each subsequent 21-day cycle thereafter as well as at study drug completion or discontinuation visit (up to 20 months)|The ITT population included all randomized participants grouped according to the treatment assigned at randomization.|||Participants|||Count of Participants
2602335|NCT02144012|Secondary|Patient-Reported Outcomes: Number of Participants Who Completed the Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Questionnaire|The FACT-B (version 4) is a self-reported instrument which measures health-related quality of life (HRQOL) of participants with breast cancer.The FACT-B includes the breast cancer sub-scale (BCS) and is comprised of nine items specific to assessing patients' HRQOL in breast cancer.|On the first Day of each 21-day Cycle (Day 1, 22, 43, etc.) and at study drug completion or discontinuation visit (up to 20 months)|The ITT population included all randomized participants grouped according to the treatment assigned at randomization.|||Participants|||Count of Participants
2602336|NCT02144012|Secondary|Immunogenicity: Percentage of Positive Anti-Therapeutic Antibody (ATA) Response to Trastuzumab Emtansine||Day 1, Cycle 1 (Day 1), Day 1, Cycle 4 (Day 64) and at study drug completion or discontinuation visit (up to 20 months)|The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Only participants with at least one post-dose sample available for ATA analysis were analyzed for this outcome measure.|||percentage of participants|||Number
2602337|NCT02144012|Secondary|Pharmacokinetics: Serum Concentrations of Study Medications|Pharmacokinetic (PK) parameters were to be determined in a subset of participants. PK samples from the first 100 Chinese participants were planned to be collected.|Day 1, Cycle 1 (Day 1), Day 1, Cycle 2 (Day 22), Day 1, Cycle 4 (Day 64) and at study drug completion or discontinuation visit (up to 20 months)|No PK analyses were performed as no participants were enrolled from China and no samples were collected.||||||
2602338|NCT02144012|Secondary|Duration of Response (DOR)|DOR was defined as the time from the date of initial confirmed PR or CR to the date of disease progression or death within the study. CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions. Disease progression was defined according to RECIST, v1.1 as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions.|At time of clinical data cut-off (up to 20 months)|The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Participants, for whom data were collected, are included in the analysis for this outcome measure.|||months||95% Confidence Interval|Median
2602339|NCT02144012|Secondary|Objective Response Rate (ORR)|ORR was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of RECIST v1.1. Tumor assessments were performed with computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest, abdomen, and pelvis. CR: disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate (OR) = CR + PR.|At time of clinical data cut-off (up to 20 months)|The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Participants, for whom data were collected, are included in the analysis for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2602340|NCT02144012|Secondary|OS Truncated at 2 Years|OS truncated at 2 years was defined as the time from the date of randomization to the date of death from any cause, with deaths occurring beyond 2 years after the participant's randomization date censored at 2 years.|At 24 months|Data for this outcome measure were not collected and are therefore not reported. The study was terminated before the time point for data collection of this outcome measure.||||||
2602382|NCT02143310|Primary|Lung Function Tests|Forced Vital Capacity (FVC)|24 months||||Liters||Standard Deviation|Mean
2602341|NCT02144012|Secondary|One-Year Survival Rate|One-year survival rate as determined by Kaplan-Meier estimates.|At 12 months|The ITT population included all randomized participants grouped according to the treatment assigned at randomization. Participants, for whom data were collected, are included in the analysis for this outcome measure.|||percentage of participants||95% Confidence Interval|Median
2602342|NCT02144012|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause.|At time of clinical data cut-off (up to 20 months)|The ITT population included all randomized participants grouped according to the treatment assigned at randomization.|||months||95% Confidence Interval|Median
2602343|NCT02144012|Primary|Safety: Percentage of Participants With Significant Decline in Left Ventricular Ejection Fraction (LVEF)|Significant decline in LVEF was defined as LVEF below 50% and decrease from baseline of 15% points or more. Echocardiogram or multiple-gated acquisition (MUGA) scan was used to assess LVEF.|At time of clinical data cut-off (up to 20 months)|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.|||percentage of participants|||Number
2602344|NCT02144012|Primary|Safety: Percentage of Participants With Adverse Events Leading to Dose Reduction||At time of clinical data cut-off (up to 20 months)|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.|||percentage of participants|||Number
2602345|NCT02144012|Primary|Safety: Percentage of Participants With Adverse Events Leading to Treatment Interruption||At time of clinical data cut-off (up to 20 months)|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.|||percentage of participants|||Number
2602346|NCT02144012|Primary|Percentage of Participants With Adverse Events Leading to Treatment Discontinuation||At time of clinical data cut-off (up to 20 months)|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.|||percentage of participants|||Number
2602347|NCT02144012|Primary|Safety: Percentage of Participants With Grade 3 and 4 AEs|Grade 3 and 4 AEs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. Grade 3 was defined as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living, including bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. Grade 4 was defined as life-threatening consequences; urgent intervention indicated.|At time of clinical data cut-off (up to 20 months)|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.|||percentage of participants|||Number
2602348|NCT02144012|Primary|Safety: Percentage of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|At time of clinical data cut-off (up to 20 months)|The safety analysis population consisted of all participants who received at least one dose of study drug. Safety analyses were based on the treatment that participants actually received.|||percentage of participants|||Number
2602349|NCT02144012|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeter (mm) or the appearance of one or more new lesions.|At time of clinical data cut-off (up to 20 months)|The intent-to-treat (ITT) population included all randomized participants grouped according to the treatment assigned at randomization.|||months||95% Confidence Interval|Median
2602350|NCT02143947|Secondary|Maximum First Ray Complex Plantarflexion During Stance|The first ray complex plantarflexion during the stance phase of walking with the subject wearing a sandal and their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization) was recorded 5 weeks post receiving their assigned orthotic. The stance phase of walking was divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the maximum first ray complex plantarflexion during each subphase determined.|Absolute values measured at 5 weeks|The number of participants used for the analysis was based upon the availability of complete data sets.|||Degrees||Standard Deviation|Mean
2602351|NCT02143947|Secondary|Maximum Forefoot Inversion During Stance|The forefoot inversion motion during the stance phase of walking with the subject wearing a sandal and their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization) was recorded 5 weeks post receiving their assigned orthotic. The stance phase of walking was divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the maximum forefoot inversion during each subphase determined.|Absolute values measured at 5 weeks|The number of participants used for the analysis was based upon the availability of complete data sets.|||Degrees||Standard Deviation|Mean
2602383|NCT02143310|Primary|Electrocardiogram (ECG): PR Interval|In electrocardiography, the PR interval is the period that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex. Variations in the PR interval can be associated with certain medical conditions.|24 months||||ms||Standard Deviation|Mean
2602384|NCT02143310|Primary|Blood Pressure|Sitting systolic blood pressure (mmHg)|24 months||||mmHg||Standard Deviation|Mean
2602385|NCT02143141|Secondary|Nausea/Vomiting|The nausea/vomiting assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no nausea/vomiting to 100 indicating the most severe nausea/vomiting.|24 hours||||units on a scale||Standard Deviation|Mean
2602352|NCT02143947|Secondary|Maximum Electromyographic Activity of Lower Leg Muscles|The maximum electromyographic activity of the lower leg muscles is with respect to the barefoot condition. The electromyographic activity of the lower extremity muscles were recorded during the stance phase of walking while barefoot and while wearing their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization). All electromyographic measurements were taken at the 5 week time point. The peak electromyographic activity during the stance phase of barefoot walking was determined. The electromyographic activity during the orthotic condition was amplitude normalized to the barefoot condition by dividing the electromyographic activity of the orthotic condition by the peak barefoot electromyographic activity and multiplying by 100. The stance phase of walking was then divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the peak amplitude normalized electromyographic activity of each subphase det|Absolute values measured at 5 weeks|The number of participants used for the analysis was based upon the availability of complete data sets.|||percentage of maximum electromyo actvity||Standard Deviation|Mean
2602353|NCT02143947|Primary|Maximum Rearfoot Eversion Motion During Stance|The rearfoot eversion motion during the stance phase of walking with the subject wearing a sandal and their assigned orthotic (Full Contact or Maximal Arch Subtalar Stabilization) was recorded 5 weeks post receiving their assigned orthotic. The stance phase of walking was divided into 4 subphases (Phase 1: 0 to 17%, Phase 2: 18 to 50%, Phase 3: 51 to 83%, and Phase 3: 84 to 100% of stance) and the maximum rearfoot eversion during each subphase determined.|Absolute values measured at 5 weeks|The number of participants used for the analysis was based upon the availability of complete data sets.|||Degrees||Standard Deviation|Mean
2602354|NCT02143843|Secondary|Change From Baseline in Mean Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (Time (T)=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Months 3, 6, 7 and 13. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal time-point, then averaged over 0, 2, and 8 hour to get the mean IOP. The change from baseline in mean IOP was calculated. The median value over the 13 month period is reported. A negative change from Baseline indicated an improvement. Baseline is defined as the IOP assessment done at the last visit (Month 6) of study FSV5-002 [NCT01915940].|Baseline (Day 1) to Month 13|Full Analysis Set (FAS) included all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed,|||mm Hg||Inter-Quartile Range|Median
2602355|NCT02143843|Primary|Percentage of Participants With Ocular and Non-ocular Adverse Events (AE) by Severity|An AE was defined as any untoward medical occurrence (eg, sign, symptom, disease, syndrome, intercurrent illness) that occurred in a study participant, regardless of the suspected cause during the study. An ocular AE is an AE that occurred in the eye and non-ocular is an AE that occurred not in the eye. The investigator assessed the worst severity of each AE as: Mild=aware of sign or symptom, but readily tolerated, Moderate=discomfort enough to cause interference with usual activity or Severe=incapacitating with inability to work or do usual activity.|13 months|Safety population included all randomized participants who had ocular inserts placed in their eyes.|||percentage of participants|||Number
2602356|NCT02143778|Secondary|Hepatic Venous Pressure Gradient (HVPG)>=12; Severe Portal Hypertension (SPH)|Hepatic Venous Pressure Gradient greater than 12 (SPH) is an indicator of bleeding varices. whereby the portal pressure leaving the liver is measured by using a balloon catheter before and after a wedge. The difference of the pressure between the wedge and the free is the hepatic venous pressure gradient. Methacetin breath test is hypothesized to also identify SPH and the agreement to the reference standard (HVPG) will be assessed in this study.|1 hour|Compensated cirrhotic Patients with Severe Portal Hypertension based on MBT compared to HVPG (reference standard)|||percentage of agreement||95% Confidence Interval|Mean
2602357|NCT02143778|Primary|CSPH (Clinically Significant Portal Hypertension)|Clinically significant portal hypertension is defined as Hepatic Venous Pressure Gradient (HVPG)>=10mmHg, whereby the portal pressure leaving the liver is measured by using a balloon catheter before and after a wedge. The difference of the pressure between the wedge and the free is the hepatic venous pressure gradient. Methacetin breath test is hypothesized to also identify CSPH and the agreement to the reference standard (HVPG) will be assessed in this study.|1 hour|Compensated cirrhotic patients with CSPH based on breath test compared to CSPH from HVPG (reference standard)|||percentage of agreement||95% Confidence Interval|Mean
2602358|NCT02143713|Secondary|Number of Days in Hospital During the Treatment Period|The Health Resource Use Questionnaire (HRUQ) was used to collect information on non-study-related health visits that participants had during the study, including physician visits, hospitalizations and types of procedures received.|6 months|Participants who received at least 1 dose of double-blind study drug in this extension study and who underwent hospitalization|||days||Full Range|Median
2602359|NCT02143713|Secondary|Number of Participants With Non-study Health Visits During the Treatment Period|The Health Resource Use Questionnaire (HRUQ) was used to collect information on non-study-related health visits that participants had during the study.|6 months|Participants who received at least 1 dose of double-blind study drug in this extension study|||Participants|||Count of Participants
2602360|NCT02143713|Secondary|Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household|"The HRPQ consists of 9 questions measuring the impact of endometriosis-associated pain and its treatment on work productivity and daily activities in the home.~Absenteeism: Number of hours of intended work lost due to illness or treatment. Presenteeism: Number of hours of work where output was impacted by illness or treatments.~Total hours lost is the sum of hours missed due to absenteeism plus presenteeism."|Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and Month 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point. Hours lost from workplace were only calculated for participants who were employed.|||hours||Standard Deviation|Mean
2602386|NCT02143141|Secondary|Itching|The itching assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no itching to 100 indicating the most severe itching.|24 hours||||units on a scale||Standard Deviation|Mean
2602361|NCT02143713|Secondary|Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension|"The EHP-30 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-30 consists of two parts: a core questionnaire containing 5 scales that are applicable to all women with endometriosis and a modular part containing 6 scales which do not necessarily apply to all women with endometriosis; only 1 modular questionnaire (sexual intercourse [5 items]) was used in this study.~The Sexual Intercourse dimension consists of 5 questions, each answered on the following scale: 0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Always, or Not Applicable (not scored). The dimension score ranges from 0 to 100, where 0 = best possible health status as measured by the questionnaire; 100 = worst possible health status. A negative change from baseline score indicates improvement in quality of life."|Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 3, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.|||units on a scale||Standard Deviation|Mean
2602362|NCT02143713|Secondary|Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension|"The EHP-30 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-30 consists of two parts: a core questionnaire containing 5 scales that are applicable to all women with endometriosis and includes pain, control and powerlessness, emotional well-being, social support, and self-image, and a modular part containing 6 scales which do not necessarily apply to all women with endometriosis.~Each question in the core questionnaire is scored on the following scale: 0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Always.~The pain dimension consists of 11 questions. The dimension score ranges from 0 to 100, where 0 = best possible health status as measured by the questionnaire; 100 = worst possible health status. A negative change from baseline score indicates improvement in quality of life."|Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 3, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.|||units on a scale||Standard Deviation|Mean
2602363|NCT02143713|Secondary|Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved|"The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:~Very Much Improved~Much Improved~Minimally Improved~Not Changed~Minimally Worse~Much Worse~Very Much Worse"|Months 1, 2, 3, 4, 5, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point.|||percentage of participants|||Number
2602364|NCT02143713|Secondary|Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS)|The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Participants were asked to assess their endometriosis pain over the past 24 hours at it's worst at approximately the same time every day in the e-Diary. Pain scores were averaged over the 35 days prior to each visit.|Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.|||percent change||Standard Deviation|Mean
2602365|NCT02143713|Secondary|Change From Baseline in Opioid Rescue Analgesic Use|Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, or codeine 30 mg + acetaminophen 300 mg, or codeine 30 mg, or tramadol 37.5 mg + acetaminophen 325 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. Opioid rescue analgesic use was calculated as the total number of opioid pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day.|Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.|||pills/day||Standard Deviation|Mean
2602366|NCT02143713|Secondary|Change From Baseline in NSAID Rescue Analgesic Use|Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, or codeine 30 mg + acetaminophen 300 mg, or codeine 30 mg, or tramadol 37.5 mg + acetaminophen 325 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. NSAID rescue analgesic use was calculated as the total number of NSAID pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day.|Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.|||pills/day||Standard Deviation|Mean
2602387|NCT02143141|Primary|Pain|Pain assessment is made using a Visual Analog Scale (VAS). VAS is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. Scale ranges from 0 indicating no pain to 100 indicating the most severe pain.|24 hours||||units on a scale||Standard Deviation|Mean
2602388|NCT02143102|Primary|Measurement Bias of Lipid-rich Necrotic Core Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.|Performance of measurements was assessed by estimating the bias (the difference between the measurement and histology)|Assessed on tissue samples collected within 30 days of non-invasive imaging||||mm2||95% Confidence Interval|Mean
2602367|NCT02143713|Secondary|Change From Baseline in Any Rescue Analgesic Use|Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, or codeine 30 mg + acetaminophen 300 mg, or codeine 30 mg, or tramadol 37.5 mg + acetaminophen 325 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. Any rescue analgesic use (NSAID and/or opioid) was calculated as the total number of pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day.|Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.|||pills/day||Standard Deviation|Mean
2602368|NCT02143713|Secondary|Percent Change From Baseline in Dyspareunia Based on Daily Assessment|"Participants assessed dyspareunia each day in an e-Diary according to the following response options:~0: None; No discomfort during sexual intercourse~1: Mild; Able to tolerate the discomfort during sexual intercourse~2: Moderate; Intercourse was interrupted due to pain~3: Severe; Avoided intercourse because of pain~Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.~Pain scores were averaged over the 35 days prior to each visit. Responses of Not Applicable were excluded."|Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study and with available baseline data and data at each time point; participants with responses of 'Not Applicable' on all reported days during baseline or for the entire time point were excluded from the analysis.|||percent change||Standard Deviation|Mean
2602369|NCT02143713|Secondary|Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment|"Participants assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options:~0: No discomfort~1: Mild discomfort but I was easily able to do the things I usually do~2: Moderate discomfort or pain that made it difficult to do some of the things I usually do~3: Severe pain that made it difficult to do the things I usually do.~Pain scores were averaged over the 35 days prior to each visit."|Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.|||percent change||Standard Deviation|Mean
2602370|NCT02143713|Secondary|Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment|"Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary according to the following response options:~0: No discomfort~1: Mild discomfort but I was easily able to do the things I usually do~2: Moderate discomfort or pain that made it difficult to do some of the things I usually do~3: Severe pain that made it difficult to do the things I usually do.~Pain scores were averaged over the 35 days prior to each visit."|Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.|||percent change||Standard Deviation|Mean
2602371|NCT02143713|Secondary|Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment|"Response was defined as a reduction of −0.29 or more from baseline in dyspareunia (pain during sexual intercourse) as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average rescue analgesic pill count and no additional analgesics).~Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed dyspareunia each day in an e-Diary. Dyspareunia was assessed according to the following:~0: None; No discomfort during sexual intercourse~1: Mild; Able to tolerate the discomfort during sexual intercourse~2: Moderate; Intercourse was interrupted due to pain~3: Severe; Avoided intercourse because of pain~Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.~Pain scores and analgesic use were averaged over the 35 days prior to each visit. Responses of Not Applicable were excluded."|Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6|"Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point; if a participant's mean score was not defined because all reports in that month were Not Applicable, then that mean score was treated as missing."|||percentage of participants|||Number
2602372|NCT02143713|Secondary|Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment|"Response was defined as a reduction of −0.43 or greater from baseline for non-menstrual pelvic pain as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average pill count of rescue analgesics and no additional analgesics). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-671.~Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options:~0: No discomfort~1: Mild discomfort but I was easily able to do the things I usually do~2: Moderate discomfort or pain that made it difficult to do some of the things I usually do~3: Severe pain that made it difficult to do the things I usually do.~Pain scores and analgesic use were averaged over the 35 days prior to each visit."|Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5|Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point|||percentage of participants|||Number
2602373|NCT02143713|Secondary|Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment|"Response was defined as a reduction of -0.85 or more from baseline in dysmenorrhea (pain during menstruation) as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average rescue analgesic pill count and no additional analgesic). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-671.~Participants recorded rescue analgesic use for endometriosis-associated pain daily and dysmenorrhea and its impact on daily activities each day of their period in an electronic diary (e-Diary). Dysmenorrhea was assessed according to the following:~0: No discomfort~1: Mild discomfort but I was easily able to do the things I usually do~2: Moderate discomfort or pain that made it difficult to do some of the things I usually do~3: Severe pain that made it difficult to do the things I usually do.~Analgesic use and pain scores were averaged over the 35 days prior to each visit."|Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5|Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point|||percentage of participants|||Number
2602374|NCT02143713|Primary|Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment|"Response was defined as a reduction of −0.43 or greater from baseline for non-menstrual pelvic pain as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average pill count of rescue analgesics and no additional analgesics). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-671.~Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options:~0: No discomfort~1: Mild discomfort but I was easily able to do the things I usually do~2: Moderate discomfort or pain that made it difficult to do some of the things I usually do~3: Severe pain that made it difficult to do the things I usually do.~Pain scores and analgesic use were averaged over the 35 days prior to each visit."|Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and Month 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline and month 6 data.|||percentage of participants|||Number
2602375|NCT02143713|Primary|Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment|"Response was defined as a reduction of -0.85 or more from baseline in dysmenorrhea (pain during menstruation) as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average rescue analgesic pill count and no additional analgesic). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-671.~Participants recorded rescue analgesic use for endometriosis-associated pain daily and dysmenorrhea and its impact on daily activities each day of their period in an electronic diary (e-Diary). Dysmenorrhea was assessed according to the following:~0: No discomfort~1: Mild discomfort but I was easily able to do the things I usually do~2: Moderate discomfort or pain that made it difficult to do some of the things I usually do~3: Severe pain that made it difficult to do the things I usually do.~Analgesic use and pain scores were averaged over the 35 days prior to each visit."|Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and Month 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline and month 6 data.|||percentage of participants|||Number
2602376|NCT02143583|Secondary|Average of the Total Score of the Validated Mini Rhinoconjunctivitis Quality-of-life Questionnaire© (Mini RQLQ) Obtained Weekly During the Birch Pollen Season|"The Mini-RQLQ will be used. This evaluation tool includes 14 questions assessing 5 domains (activity limitation, practical problems, nose symptoms, eye symptoms, and non-nose/eye symptoms).~For each question the answer is quoted from 0: no troubled to 6: extremely troubled; then the average of the score for the 14 questions is calculated resulting in a scale from 0 to 6, 0 being the best case and 6 the worst case"|between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3|Modified-ITT analysis set : patients having received at least 4 injections of AllerT or placebo in AN004T|||units on a scale||Standard Deviation|Mean
2602377|NCT02143583|Primary|Average of the Combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) Obtained Daily During the Birch Pollen Season|"The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2 The Rhinoconjunctivitis Symptom Score (RSS) comprises 6 different symptoms from the nose and eyes. The sum of the 6 symptom scores divided by 6 will be used as the RSS (scale of 0 to 3).~The daily Rhinoconjunctivitis Medication Score (RMS) will be determined by assigning daily scores as follows:~0 = no medication~= subject took topical antihistamine~= subject took oral antihistamine~= subject took oral corticosteroids"|from the first of 3 consecutive days with a regional pollen count > 10 grains/m3 to the earliest between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count ≥ 10 grains/m3|Modified-ITT analysis set : participants having received at least 4 injections of AllerT or placebo in AN004T|||units on a scale||Standard Deviation|Mean
2602378|NCT02143310|Secondary|Biomarkers of Effect|Change from BL in the level of white blood cells.|24 months||||G/L||95% Confidence Interval|Mean
2602379|NCT02143310|Secondary|Biomarkers of Exposure to Nicotine|The exposure to nicotine was measured by quantifying the change from BL in the amount of nicotine equivalents excreted in urine in 24-hours (AE24h).|24 months||||mg||95% Confidence Interval|Mean
2602380|NCT02143310|Secondary|Nicotine Withdrawal Symptoms|Nicotine withdrawal symptoms were measured using the revised Minnesota Nicotine Withdrawal Scale (MWS-R) questionnaire. Extended total scores were used, i.e. the sum of the scores of all 15 questions of the questionnaire. Symptoms (e.g. angry, irritable, frustrated, depressed, restless, insomnia) were rated from 0 (none) to 4 (severe). Extended total scores may range from 0 to a maximum of 60.|24 Months||||score on a scale||Standard Deviation|Mean
2602389|NCT02143102|Primary|Measurement Bias of Calcification Analyzed by vascuCAP™ Non-invasively Relative to Histopathology as Ground Truth.|Performance of measurements was assessed by estimating the bias (the difference between the measurement and histology)|Assessed on tissue samples collected within 30 days of non-invasive imaging||||mm2||95% Confidence Interval|Mean
2602390|NCT02143024|Primary|Depressive Symptoms|Patient Health Questionnaire (PHQ-9) scale; 0-27 scoring units; higher scores indicate more severe depressive symptoms.|baseline, 3 months, and 6 months||||units on a scale||Standard Deviation|Mean
2602391|NCT02142894|Primary|Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity|To evaluate the clinical sensitivity of the CST001 assay in patients who have clinical signs/symptoms strongly indicating TB disease and who are receiving or have to start treatment for active TB, and whom Mycobacterium tuberculosis (MTB) is confirmed by bacteriological culture. Patients included in the testing either had a positive acid-fast bacillus (AFB) smear of have MTB in a specimen detected by nucleic acid amplification (NAA) of MTB complex Polymerase Chain Reaction (PCR), and who have received treatment for no more than 14 days upon enrollment.|At time of enrollment||||Participants|||Count of Participants
2602392|NCT02142738|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants in the analysis population who experienced a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The ORR through the data cutoff date of 09 May 2016 is presented for each treatment group.|Through data cutoff data of 09 May 2016 (Up to approximately 1.6 years)|The ITT population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2602393|NCT02142738|Secondary|Overall Survival (OS) Rate at Month 6|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. In those instances where participants were confirmed to be alive on the visit cut-off date of 09 May 2016, survival was censored as of 09 May 2016. The OS rate at Month 6 was calculated.|Month 6|The ITT population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2602394|NCT02142738|Primary|Progression Free Survival (PFS) Rate at Month 6|PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent central radiologists' (BICR) review. Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. (Note: the appearance of one or more new lesions was also considered progression). Participants were evaluated every 9 weeks with radiographic imaging to assess their response to treatment. The PFS rate at Month 6 was calculated.|Month 6|The Intention-to-treat (ITT) population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2602395|NCT02142712|Other Pre-specified|CT or MRI of Head Without Contrast|MRI of head or CT head done as part of your follow up care at 3 months. This will give us the information about the effect of dextromethorphan effect on the final brain damage from stroke.|At 3 months from baseline|The data was not collected since the participants did not come back for follow-ups.||||||
2602396|NCT02142712|Primary|Barthel Index|"It is an ordinal scale used to measure performance in activities of daily living (ADL). Each performance item is rated on this scale with a given number of points assigned to each level or ranking. It uses ten variables describing ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. It yields a score of 0-20.~The ten variables addressed in the Barthel scale are:~presence or absence of fecal incontinence~presence or absence of urinary incontinence~help needed with grooming~help needed with toilet use~help needed with feeding~help needed with transfers (e.g. from chair to bed)~help needed with walking~help needed with dressing~help needed with climbing stairs~help needed with bathing"|At 3 months from baseline|The data was not collected since the participants did not come back for follow-ups.||||||
2602397|NCT02142712|Primary|Glasgow Coma Scale (GCS)|Glasgow Coma Scale (GCS) is assessed by physical neurological examination of the subject by a qualified neurologist. GSC is a common scoring system used to describe the level of consciousness in a person following a traumatic brain injury. The initial score correlates with the severity of brain injury and prognosis. It estimates Coma severity based on Eye (4), Verbal (5), and Motor (6) criteria with the following total score of between 3 (indicating deep unconsciousness) and 15 (indicating no issues).|Baseline|Data was collected only for the baseline visit, since the participants did not come back for follow-ups.|||Glasgow Coma Scale|||Number
2602398|NCT02142712|Primary|National Institutes of Health Stroke Severity (NIHSS) Scale|NIHSS is a tool used by healthcare providers to objectively quantify the degree of impairment caused by a stroke. It is composed of 11 items. Each item scores a specific ability between a score of 0-4. Usually, for each item, a score of 0 indicates normal function in that specific ability, while a higher score indicates some level of impairment. The individual scores from each item are added together to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.|Baseline|NIHSS data was only collected for the baseline visit, since the participants did not come back for follow-ups.|||NIHSS scale|||Number
2602412|NCT02142504|Secondary|Percentage of Participants With a Seroresponse in Serum Anti-norovirus GI.1 VLP (Pan-Ig ELISA)|Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-Like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).|Baseline and Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2602963|NCT02137512|Secondary|Time Spent >180 mg/dL - Main Phase, Day Only|Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase, day only (07:00 - 23:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602399|NCT02142712|Primary|Modified Rankin Score|"The modified Rankin Scale (m-RS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people after they have suffered a stroke.It is one of the most widely used clinical outcome measure for stroke clinical trials. The score is given according to following scale.~0- No symptoms at all~No significant disability despite symptoms; able to carry out all usual duties and activities~Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance~Moderate disability; requiring some help, but able to walk without assistance~Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance~Severe disability; bedridden, incontinent and requiring constant nursing care and attention~Dead"|8 days and 3 months from the baseline|The data was not collected since the participants did not come back for follow-ups.||||||
2602400|NCT02142504|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)|Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA binding assay.|Day 28|Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data available for this outcome measure.|||ratio||Standard Deviation|Geometric Mean
2602401|NCT02142504|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)|Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.|Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||ratio||Standard Deviation|Geometric Mean
2602402|NCT02142504|Secondary|Blocking Titers 50 (BT50) of Anti-Norovirus GII.4 VLP Antibody Titers (HBGA)|Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay.|Day 28|Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data available for this outcome measure.|||titer||Standard Deviation|Geometric Mean
2602403|NCT02142504|Secondary|Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)|Blocking titers 50 (BT50) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.|Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||titer||Standard Deviation|Geometric Mean
2602404|NCT02142504|Secondary|Percentage of Participants With a Seroresponse in Serum GII.4 VLP Antibody Titers (HBGA)|Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-Like particle (VLP) as measured by HBGA binding assay.|Baseline and Day 28|Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data for this outcome measure|||percentage of participants||95% Confidence Interval|Number
2602405|NCT02142504|Secondary|Percentage of Participants With a Seroresponse in Serum GI.1 VLP Antibody Titers (HBGA)|Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-Like particle (VLP) as measured by HBGA binding assay.|Baseline and Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2602406|NCT02142504|Secondary|Percentage of Participants With a Seroresponse in Both Serum Anti-norovirus GI.1 VLP and GII.4 VLP (HBGA)|Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by histoblood group antigen (HBGA) binding assay.|Baseline and Day 28|Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data available for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2602407|NCT02142504|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)|Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by Pan-Ig ELISA.|Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||ratio||Standard Deviation|Geometric Mean
2602408|NCT02142504|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)|Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by Pan-Ig ELISA.|Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||ratio||Standard Deviation|Geometric Mean
2602409|NCT02142504|Secondary|Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)|Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by Pan-Ig ELISA.|Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||titer||Standard Deviation|Geometric Mean
2602410|NCT02142504|Secondary|Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)|Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by Pan-Ig ELISA.|Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||titer||Standard Deviation|Geometric Mean
2602411|NCT02142504|Secondary|Percentage of Participants With a Seroresponse in Serum Anti-norovirus GII.4 VLP (Pan-Ig ELISA)|Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-like particles (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).|Baseline and Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2603261|NCT02134119|Secondary|Hematological Measures - Red Blood Cells|as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)||||M/uL||Standard Deviation|Mean
2602413|NCT02142504|Secondary|Percentage of Participants With a Seroresponse in Both Serum Anti-norovirus GI.1 VLP and GII.4 VLP (Pan-Ig ELISA)|Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).|Baseline and Day 28|Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2602414|NCT02142504|Secondary|Percentage of Participants With Unsolicited Adverse Events (AEs) After the Second Injection|Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.|Days 365 through 393|Participants from the Safety Analysis Set who received a second injection.|||percentage of participants|||Number
2602415|NCT02142504|Secondary|Percentage of Participants With Elevated Daily Oral Temperature (Fever) After the Second Injection|Fever is defined as greater than or equal to 38°C (100.4°F). Oral body temperature measurement was performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day was recorded on the Diary Card also provided by the site.|Days 365 through 371|Participants from the Safety Analysis Set who received a second injection.|||percentage of participants|||Number
2602416|NCT02142504|Secondary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the Second Injection|Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after the vaccination on Day 365.|Days 365 through 371|Participants from the Safety Analysis Set who received a second injection.|||percentage of participants|||Number
2602417|NCT02142504|Secondary|Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the Second Injection|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after the vaccination on Day 365.|Days 365 through 371|Participants from the Safety Analysis Set who received a second injection.|||percentage of participants|||Number
2602418|NCT02142504|Primary|Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study|Withdrawal due to an AE occurred if the participant experienced an AE that required early termination because continued participation imposed an unacceptable risk to the participant's health or the participant was unwilling to continue because of the AE.|Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)|Safety Analysis Set included all participants who received at least one dose of trial vaccination.|||percentage of participants|||Number
2602419|NCT02142504|Primary|Percentage of Participants With Adverse Events of Special Interest (AESI) After the Second Injection|AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESI included protocol specified Cardiac Disorders, Gastrointestinal Disorders, Immune System Disorders, Infections and Infestations, Musculoskeletal and Connective Tissue Diseases, Neuroinflammatory Disorders, Renal and Urinary Disorders, Skin Disorders, Thyroid Disorders, Vascular Disorders and Other Disorders.|From second injection (Day 365) to 6 months after second injection (Up to Day 545)|Participants from the Safety Analysis Set who received a second injection.|||percentage of participants|||Number
2602420|NCT02142504|Primary|Percentage of Participants With Adverse Events of Special Interest (AESI) After the First Injection|AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESI included protocol specified Cardiac Disorders, Gastrointestinal Disorders, Immune System Disorders, Infections and Infestations, Musculoskeletal and Connective Tissue Diseases, Neuroinflammatory Disorders, Renal and Urinary Disorders, Skin Disorders, Thyroid Disorders, Vascular Disorders and Other Disorders.|From first injection (Day 1) to second injection pre-dose (Up to Day 365)|Safety Analysis Set included all participants who received at least one dose of trial vaccination.|||percentage of participants|||Number
2602421|NCT02142504|Primary|Percentage of Participants With Serious Adverse Events (SAEs) After the Second Injection|A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|From second injection (Day 365) to 6 months after second injection (Up to Day 545)|Participants from the Safety Analysis Set who received a second injection.|||percentage of participants|||Number
2602422|NCT02142504|Primary|Percentage of Participants With Serious Adverse Events (SAEs) After the First Injection|A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|From first injection (Day 1) to second injection pre-dose (Up to Day 365)|Safety Analysis Set included all participants who received at least one dose of trial vaccination.|||percentage of participants|||Number
2602423|NCT02142504|Primary|Percentage of Participants With Unsolicited Adverse Events (AEs) After the First Injection|Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.|Days 1 through 28|Safety Analysis Set included all participants who received at least one dose of trial vaccination.|||percentage of participants|||Number
2602424|NCT02142504|Primary|Percentage of Participants With Elevated Daily Oral Temperature (Fever) After the First Injection|Fever is defined as greater than or equal to 38°C (100.4°F). Oral body temperature measurement was performed using the thermometer provided by the site for 7 days after each injection. The highest body temperature observed each day was recorded on the Diary Card also provided by the site.|Days 1 through 7|Safety Analysis Set included all participants who received at least one dose of trial vaccination.|||percentage of participants|||Number
2602425|NCT02142504|Primary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the First Injection|Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after the primary injection.|Days 1 through 7|Safety Analysis Set included all participants who received at least one dose of trial vaccination.|||percentage of participants|||Number
2602426|NCT02142504|Primary|Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the First Injection|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after the primary injection.|Days 1 through 7|Safety Analysis Set included all participants who received at least one dose of trial vaccination.|||percentage of participants|||Number
2602427|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Comfort|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
2602428|NCT02142361|Primary|Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye|Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||degrees|Participants|Standard Deviation|Mean
2602429|NCT02142361|Primary|Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye|Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||degrees|Participants|Standard Deviation|Mean
2602430|NCT02142361|Primary|Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye|Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
2602431|NCT02142361|Primary|Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye|Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
2602432|NCT02142361|Primary|Clinician's Assessment Post-Blink Movement-Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
2602433|NCT02142361|Primary|Clinician's Assessment Post-Blink Movement- Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
2602434|NCT02142361|Primary|Clinicians Assessment Corneal Coverage-Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no incomplete corneal coverage)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
2602435|NCT02142361|Primary|Clinician's Assessment Corneal Coverage-Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no, incomplete corneal coverage)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
2602436|NCT02142361|Primary|Clinician's Assessment Lens Centration- Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Lens centration recorded by degree and direction in the primary positions. (0-2, 0=centered/optimal, 1=decentered slightlty, 2=substantially decentered (>0.5mm)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
2602437|NCT02142361|Primary|Clinician's Assessment Lens Centration-Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Lens centration recorded by degree and direction in the primary position. (0-2, 0=centered/optimal, 1=decentered slightly, 2=substantially decentered (>0.5mm))|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
2602451|NCT02142361|Primary|Participant's Subjective Rating for Vision Stability During the Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2602438|NCT02142361|Primary|Clinician's Assessment Overall Fit Acceptance- Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
2602439|NCT02142361|Primary|Clinician's Assessment Overall Fit Acceptance- Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
2602440|NCT02142361|Primary|Clinician's Assessment Overall Lens Stability-Left Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
2602441|NCT02142361|Primary|Clinician's Assessment Overall Lens Stability-Right Eye|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
2602442|NCT02142361|Primary|Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity|Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||LogMAR||Standard Deviation|Mean
2602443|NCT02142361|Primary|Clinician's Objective Assessment Monocular High Contrast Distance Visual|Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value.|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||LogMAR||Standard Deviation|Mean
2602444|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Overall|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
2602445|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Lens Fit|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
2602446|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Vision|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
2602447|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Handling|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm.~Sum of percentage for the Study Lens Arm=101 as, Category title-  Somewhat dissatisfied- 1.7 was rounded to 2."|||percentage of eyes|Participants||Number
2602448|NCT02142361|Primary|Participant's Subjective Rating for Overall Satisfaction - Dryness|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)|Baseline and 1 week|"All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm."|||percentage of eyes|Participants||Number
2602449|NCT02142361|Primary|Participant's Subjective Rating for Lens Pair Preference|Participants subjective preference in relation to comfort, dryness, handling, vision, lens fit and overall of the patient after wearing the study and their habitual lenses.|1 week|"All 60 paticipants were analyzed for the habitual lenses. The results have been combined into a single arm Habitual Lens arm to create a single pair wise comparison to the, Study Lens arm. Vision category data for one participant was not collected."|||Percentage of eyes|Participants||Number
2602450|NCT02142361|Primary|Participant's Subjective Rating for Vision Stability at End of Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2602452|NCT02142361|Primary|Participant's Subjective Rating for Vision Stability at Insertion|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2602453|NCT02142361|Primary|Participant's Subjective Rating for Night Vision Quality|Surveyed for each lens pair. Habitual pair at baseline. Study pair dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2602454|NCT02142361|Primary|Participant's Subjective Rating for Vision Quality End of the Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week end of the day. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2602455|NCT02142361|Primary|Participant's Subjective Rating for Vision Quality During the Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2602456|NCT02142361|Primary|Participant's Subjective Rating for Vision Quality at Insertion|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week .Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2602457|NCT02142361|Primary|Participant's Subjective Rating for Overall Vision Satisfaction|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=completely dissatisfied, 10= very satisfied)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2602458|NCT02142361|Primary|Participant's Subjective Rating for Overall Lens Fit Stability|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very unstable / excessive movement, 10= very stable / good movement)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2602459|NCT02142361|Primary|Participant's Subjective Rating for Lens Handling - Insertion|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= very easy)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2602460|NCT02142361|Primary|Participant's Subjective Rating for Overall Dryness|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2602461|NCT02142361|Primary|Participant's Subjective Rating for Dryness Prior to Removal|Surveyed prior to removal of each lens pair. Habitual pair at baseline . Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2602462|NCT02142361|Primary|Participant's Subjective Rating for Dryness During the Day|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2602463|NCT02142361|Primary|Participant's Subjective Rating for Overall Lens Comfort|Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2602464|NCT02142361|Primary|Participant's Subjective Rating for Lens Comfort Prior to Removal|Surveyed prior to removal of each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2602465|NCT02142361|Primary|Participant's Subjective Rating for Lens Initial Comfort|Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)|Baseline and 1 week||||units on a scale||Standard Deviation|Mean
2602466|NCT02142283|Secondary|Neurological Deterioration From Baseline NIHSS Score|"Neurological deterioration from baseline NIHSS score through Day 5-7/discharge (whichever is earlier) post randomization. Neurological deterioration is defined as ≥ 4 point increase in the NIHSS score from the baseline score.~The calculated difference in NIHSS scores was assessed at baseline and Day 5-7/discharge (two time points).~The NIHSS is an assessment which objectively quantifies the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a total NIHSS score. The maximum possible score is 42, with the minimum score being a 0."|5-7 days|ITT|||Participants|||Count of Participants
2602467|NCT02142283|Secondary|Revascularization Rates|"Revascularization rates at 24 hours from randomization are based on the assessment of vessel patency utilizing CTA/MRA and processed by the CT-MR core laboratory. Revascularization at 24 hours was defined as the presence of partial or complete recanalization.~CTA/MRA images utilized ionizing radiation exposure."|24 hours|ITT|||Participants|||Count of Participants
2602468|NCT02142283|Secondary|All Cause Mortality||90 days|ITT|||Participants|||Count of Participants
2602469|NCT02142283|Secondary|Early Response|"The proportion of subjects with early response at Day 5-7/Discharge (whichever is earlier), defined as a National Institutes of Health Stroke Scale (NIHSS) drop of ≥10 from baseline or NIHSS score 0 or 1.~The NIHSS is an assessment which objectively quantifies the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a total NIHSS score. The maximum possible score is 42, with the minimum score being a 0."|5-7 Days||||Participants|||Count of Participants
2602721|NCT02139137|Secondary|Clinician Administered PTSD Scale Total Score - Responder Status|Number of Participants Who Responded According to Clinician Administered PTSD Scale Total Score|Week 4|Number of participants analyzed is based on the number of participants who completed the post-treatment CAPS interview.|||Participants|||Count of Participants
2602470|NCT02142283|Secondary|Good Functional Outcome|"Proportion of participants with functional independence~mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes neurological disability.~Functional Independence:~0 - no symptoms at all~- no significant disability despite symptoms; able to carry out all usual duties and activities~- slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance"|90 days|ITT|||Participants|||Count of Participants
2602471|NCT02142283|Primary|Stroke-related Mortality, Primary Safety Outcome||90 days|ITT|||Participants|||Count of Participants
2602472|NCT02142283|Primary|Functional Independence (mRS 0-2), Nested Co-Primary Efficacy Outcome|"Number of participants with functional independence~mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes neurological disability.~Functional Independence:~0 - no symptoms at all~- no significant disability despite symptoms; able to carry out all usual duties and activities~- slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance"|90 days|ITT|||Participants|||Count of Participants
2602473|NCT02142283|Primary|Weighted Modified Rankin Scale (mRS) Score, Lead Co-Primary Efficacy Outcome|"mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes neurological disability.~Functional Independence:~0 - no symptoms at all~- no significant disability despite symptoms; able to carry out all usual duties and activities~- slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance~- moderate disability; requiring some help, but able to walk without assistance~- moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance~- severe disability; bedridden, incontinent and requiring constant nursing care and attention~- dead"|90 days|ITT|||score on a scale||Standard Deviation|Mean
2602474|NCT02142153|Other Pre-specified|Pharmacokinetics|Blood samples (6 mL) for analysis of F901318 plasma concentration will be drawn pre-dose and at 1h, 2h, 3h and 4h and then 4.25, 4.5, 5.0, 5.5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96 and 120 hours following the start of the infusion. (20 samples).|Single dose|||||||
2602475|NCT02142153|Secondary|Number of Subjects With Significant Clinical Safety Labs and ECG Abnormalities|Number of subjects with significant Clinical safety labs and ECG abnormalities as judged by the investigator from screening until final study visit|Single dose||||participants|||Number
2602476|NCT02142153|Primary|Number of Subjects With Adverse Events|Adverse events will be collected from the time of screening until the final study visit|Single dose|Full analytical set|||participants|||Number
2602477|NCT02142049|Secondary|Duration of Response (DOR)|Part 2: DOR will be measured from the time by which the measurement criteria are met for CR or PR until the first date by which recurrent or progressive disease is objectively documented.|From initial response date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose.||||Months||Full Range|Median
2602478|NCT02142049|Secondary|Progression Free Survival (PFS) and Overall Survival (OS) as a Measure of Efficacy|Part 2: PFS will be measured as time from first study drug administration to disease progression or death from any cause. OS will be measured from the time of first study drug administration until the date of death using Kaplan-Meier methodology.|From initial dose date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose, up to 36 months at the most.||||Months||Full Range|Median
2602479|NCT02142049|Secondary|Number of Subjects With Adverse Events as a Measure of Safety and Tolerability|Part 2: The frequency (number and percentage) of treatment-emergent adverse events will be reported.|1 year after last subjects received the first dose||||Participants|||Count of Participants
2602480|NCT02142049|Secondary|Number of Participants With Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy|Part-1: Overall Response rate (ORR) will defined as the proportion of subjects who achieve either a CR or a PR according to the international Working Group Response Criteria for NHL as assessed by investigator.|1 year after last subjects received the first dose||||Participants|||Count of Participants
2602481|NCT02142049|Primary|Number of Participants With Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy-ORR|Part 2 - Overall Response rate will be defined as the proportion of subjects who achieve either a Complete Response or a Partial Response according to the international Working Group Response Criteria for NHL as assessed by investigator.|1 year after last subjects received the first dose||||Participants|||Count of Participants
2602482|NCT02142049|Primary|Number of Participants With Dose-Limiting Toxicities as a Measure of Safety and Tolerability|Part-1: To determine the maximum tolerated dose (MTD) of the combination of ibrutinib and lenalidomide with dose adjusted EPOCH-R|1 year after last subjects received the first dose||||Participants|||Count of Participants
2602483|NCT02141997|Secondary|Percentage of Participants Achieving CR Based on Clinical Disease Activity Index (CDAI) at Week 12|The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. CR is defined as a CDAI score ≤ 2.8 at Week 12. LOCF was used (only post-baseline values were carried forward).|Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value|||percentage of participants|||Number
2602484|NCT02141997|Secondary|Percentage of Participants Achieving LDA or CR Based on Clinical Disease Activity Index (CDAI) at Week 12|The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. LDA is defined as a CDAI score from 2.8 to ≤ 10 at Week 12. CR is defined as a CDAI score ≤ 2.8 at Week 12. LOCF was used (only post-baseline values were carried forward).|Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value|||percentage of participants|||Number
2602485|NCT02141997|Secondary|Percentage of Participants Achieving CR Based on DAS28 (hsCRP) at Week 12|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. CR is defined as a DAS28 (hsCRP) score < 2.6 at Week 12. LOCF was used (only post-baseline values were carried forward).|Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value|||percentage of participants|||Number
2602486|NCT02141997|Secondary|Percentage of Participants Achieving Low Disease Activity (LDA) or Clinical Remission (CR) Based on DAS28 (hsCRP) at Week 12|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. LDA is defined as a DAS28 (hsCRP) score from 2.6 to < 3.2 at Week 12. CR is defined as a DAS28 (hsCRP) score < 2.6 at Week 12. LOCF was used (only post-baseline values were carried forward).|Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value|||percentage of participants|||Number
2602487|NCT02141997|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12|Response defined as at least 70% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. LOCF was used (only post-baseline values were carried forward).|Baseline (Day 1) and Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value|||percentage of participants|||Number
2602488|NCT02141997|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 12|Response defined as at least 50% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hsCRP. LOCF was used (only post-baseline values were carried forward).|Baseline (Day 1) and Week 12|Participants in the FAS population with a baseline value and at least 1 post-baseline value|||percentage of participants|||Number
2602489|NCT02141997|Secondary|Change in Disease Activity Score 28 With High Sensitivity C-Reactive Protein (DAS28 [hsCRP])|The DAS28 (hsCRP) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hsCRP, and general health are included in the DAS28 (hsCRP) score. Scores range from 0 to 10: a score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. A negative change from baseline represents improvement. n=the number of participants with evaluable data at each time point. LOCF was used (only post-baseline values were carried forward).|Baseline, Weeks 2, 4, 6, 8, and 12|Subjects in the FAS with a baseline value and at least 1 post-baseline value|||units on a scale||95% Confidence Interval|Least Squares Mean
2602490|NCT02141997|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP). Last observation carried forward (LOCF) was used for missing data (only post-baseline values were carried forward).|Baseline (Day 1) and Week 12|Full analysis set (FAS) defined as all randomized participants with at least 1 dose of study drug.|||percentage of participants|||Number
2602491|NCT02141984|Secondary|Parent's Global Assessment for Effectiveness|Parent's global assessment for effectiveness was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.'|From the first administration (Day 1) to approximately 12 weeks (±4 weeks)|Effectiveness analysis set: All participants who have been administered Humira for not less than 12 (± 4) weeks or more and for whom effectiveness evaluation parameters have been recorded including active joint count as well as Physician global assessment and Parent's global assessment at baseline and 12 weeks.|||Participants|||Count of Participants
2602492|NCT02141984|Secondary|Physician's Global Assessment of the Disease|The Physician's global assessment of the disease assessment was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.'|From the first administration (Day 1) to approximately 12 weeks (±4 weeks)|Effectiveness analysis set: All participants who have been administered Humira for not less than 12 (± 4) weeks or more and for whom effectiveness evaluation parameters have been recorded including active joint count as well as Physician global assessment and Parent's global assessment at baseline and 12 weeks.|||participants|||Number
2602493|NCT02141984|Secondary|Changes in Active Joint Count From Baseline and 12 Weeks Post-Treatment|Active Joint Count will be assessed and collected by participating investigators in routine medical practice. Sixty-eight joints were assessed by physical examination. Active joints are defined as joints with positive results for tenderness, swelling, pain on passive motion, or limitation of passive motion. Higher scores represent higher disease activity.|From the first administration (Day 1) to approximately 12 weeks (±4 weeks)|Effectiveness analysis set: All participants who have been administered Humira for not less than 12 (± 4) weeks or more and for whom effectiveness evaluation parameters have been recorded including active joint count as well as Physician global assessment and Parent's global assessment at baseline and 12 weeks.|||active joint||Standard Deviation|Mean
2602516|NCT02141659|Primary|Part B: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities|Laboratory test abnormalities were graded using the CTCAE. The grades were: Grade 2- (moderate) minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL; Grade 3- (severe) medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care ADL. Data has been presented for any Grade 2 or higher event in the laboratory test abnormalities. Here aspartate aminotransferase (AST) (glutamic-oxaloacetic transaminase [GOT]) High, creatine kinase (CK) (creatine phosphokinase [CPK]) High, prothrombin time (PT)-international normalized ratio (INR) High.|From treatment initiation until 40 days after last dose of study drug (Day 712)|The safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2602494|NCT02141984|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either related, possible, probably not, not related, or unassessable. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.|Adverse Events (AEs) were collected from informed consent to within 70 days following the last scheduled administration of Humira (up to 22 weeks)|Safety analysis set: All participants who received at least one administration of Humira during the study (after informed consent or first administration of Humira) and for 70 days following the last scheduled administration of Humira.|||participants|||Number
2602495|NCT02141867|Secondary|Duration of Critical Care Stay||Upto 30 days||||Days||Inter-Quartile Range|Median
2602496|NCT02141867|Secondary|Admission to Critical Care After Surgery||Upto 30 days||||participants|||Number
2602497|NCT02141867|Secondary|Duration of Hospital Stay||Upto 30 days||||Days||Inter-Quartile Range|Median
2602498|NCT02141867|Primary|Mortality|In hospital mortality|Upto 30 days||||participants|||Number
2602499|NCT02141854|Secondary|Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 12 of the Treatment Period|Safety population|||Participants|||Count of Participants
2602500|NCT02141854|Secondary|Kaplan-Meier Estimates for Time to 15% and 12% Improvement From Baseline in FEV1 Postdose on Day 1|"The baseline forced expiratory volume in 1 second (FEV1) was the average of the 2 predose FEV1 measurements (30 and 10 minutes predose) on Day 1. If one of these was missing, the other measurement was used as baseline value. If both were missing, the baseline trough FEV1 was treated as missing.~Time to target improvement (15% or 12%) was defined as the time elapsed from the time of first dose to the first time the target improvement in FEV1 was achieved. If an exact target increase was not achieved at a measured timepoint, then the time was estimated by linear interpolation between the timepoint when target was reached and the timepoint immediately before. Patients who did not achieve the target improvement were censored at the time of last serial spirometry assessment.~Values of NA indicate the values could not be estimated which happened when the estimated probability of not achieving target is more than 50%."|Day 1 of the Treatment Period (predose and postdose)|Patients who did not achieve the target improvement were censored at the time of last serial spirometry assessment.|||hours||95% Confidence Interval|Median
2602501|NCT02141854|Secondary|Change From Baseline in the Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ(S)) Score at Endpoint for Patients >=18 Years Old|"The AQLQ(S) (September 2010 version; patients aged ≥18 years) was self administered by the patients at the investigational center at the randomization visit and at Week 12 or end of trial. The questionnaire is a tool to measure the impact of asthma on a patient's quality of life (physical, emotional, social, and occupational) with a recall period of 2 weeks. The AQLQ(S) was administered only to patients 18 years and older. The 32 individual questions in the AQLQ were equally weighted. The overall AQLQ score was the mean of the responses to each of the 32 questions, and ranged from 1 to 7. A score 7.0 indicated that the patient had no impairments due to asthma and a score of 1.0 indicated severe impairment.~Positive change from baseline scores indicate improved quality of life."|Day 1 (predose, baseline), end of trial (up to week 12)|Full analysis set of participants who contributed at least once to analysis and were >= 18 years old|||units on a scale||Standard Error|Least Squares Mean
2602502|NCT02141854|Secondary|Kaplan-Meier Estimate of Probability of Remaining in Study At Week 12|The analysis of probability of remaining in the study at Week 12 used the time to patient withdrawal for worsening asthma, defined as the number of days elapsed from the date of randomization to the date of withdrawal due to worsening asthma. Patients who were lost to follow-up, who had not withdrawn due to worsening asthma by week 12, or who had withdrawn due to reasons other than worsening asthma were right-censored at the date of last assessment.|up to Week 12 of the Treatment Period|Full analysis set|||probability||95% Confidence Interval|Number
2602503|NCT02141854|Secondary|Change From Baseline in the Weekly Average of the Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol Over the 12-Week Treatment Period|"Patients recorded the number of inhalations of rescue medication (albuterol/salbutamol HFA MDI) each AM and PM in the diary. The average number of daily inhalations over the 7 days before the randomization visit was the baseline value. The weekly average was based on the available data for the 7 days before each analysis week.~The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using a mixed model for repeated measures."|Days -6 to Day 1 (predose, baseline), up to week 12|Full analysis set|||puffs||Standard Error|Least Squares Mean
2602517|NCT02141659|Primary|Part B: Number of Participants Reporting One or More TEAE||From treatment initiation until 40 days after last dose of study drug (Day 712)|The safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2602518|NCT02141659|Primary|Part A: Number of Participants With Markedly Abnormal Values of Electrocardiogram (ECG) Parameters||From treatment initiation until 40 days after last dose of study drug (Day 68)|The safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2602519|NCT02141659|Primary|Part A: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters||From treatment initiation until 40 days after last dose of study drug (Day 68)|The safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2602504|NCT02141854|Secondary|Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over the 12-Week Treatment Period|"The total daily asthma symptom score is the average of the daytime and nighttime scores as recorded in the patient diary.~Daytime Symptom Score:~0=No symptoms~1=Symptoms for 1 short period~2=Symptoms for 2+ short periods~3=Symptoms for most of the day - did not affect normal daily activities~4=Symptoms for most of the day - did affect normal daily activities~5=Symptoms so severe that I could not go to work or perform normal daily activities~Nighttime Symptom Score (determined in the AM):~0=No symptoms~1=Symptoms causing me to wake once (or wake early)~2=Symptoms causing me to wake twice or more (including waking early)~3=Symptoms causing me to be awake for most of the night~4=Symptoms so severe that I did not sleep Baseline was the average of recorded scores over the 7 days before randomization. The change from baseline in the weekly average over weeks 1 to 12 was analyzed using an mixed model for repeated measures (MMRM)."|Days -6 to Day 1 (predose, baseline), to Week 12|Full analysis set|||units on a scale||Standard Error|Least Squares Mean
2602505|NCT02141854|Secondary|Change From Baseline in the Weekly Average of the Daily Morning Trough Peak Expiratory Flow (PEF) Over the 12 Week Treatment|"Morning PEF tests were performed before administration of study drug or rescue medications (data were excluded if the time of PEF measurement was more than 5 minutes after the dose time). The patient recorded the highest value of 3 measurements obtained in the patient diary.~The baseline PEF was the average value of recorded (nonmissing) morning assessments over the 7 days prior to randomization on Day 1. For efficacy analyses of weekly average morning PEF measurements, values were the averages based on available data for that week."|Days -6 to Day 1 (predose, baseline), Day 1 (postdose) daily until Week 12|Full analysis set|||liters/minute||Standard Error|Least Squares Mean
2602506|NCT02141854|Primary|Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12|Trough FEV1 is a morning spirometry taken predose and pre-rescue bronchodilator. The baseline for predose FEV1 was defined as the average of the 30-minute and 10-minute predose measurements obtained at the randomization visit (Day 1).|Day 1 (predose, baseline), Week 12|If the patient inadvertently administered asthma medication/study drug at home on the AM of the visit, or if the patient took rescue medication within 6 hours of testing, the visit was rescheduled.|||liters||Standard Error|Least Squares Mean
2602507|NCT02141854|Primary|Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours PostDose (FEV1 AUEC0-12) at Week 12|A subset of patients performed postdose serial spirometry. Data from these assessments were used to analyze the primary endpoint of baseline-adjusted FEV1 AUEC0-12h at week 12 using the trapezoidal rule based on actual time of measurement. It was standardized by dividing it by the number of hours between the start time of dose administration and the end time of the last nonmissing FEV1 measurement. The baseline FEV1 was the average of the 2 predose FEV1 measurements (30 and 10 minutes predose). If 1 of these was missing, the nonmissing value was used; if both were missing, baseline was treated as missing. Baseline-adjusted FEV1 was calculated as postdose FEV1 after subtracting the baseline FEV1 value.|Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hours|A subset of patients who performed postdose serial spirometry at the baseline visit and week 12.|||liters||Standard Error|Least Squares Mean
2602508|NCT02141659|Secondary|Part B: Serum Testosterone Concentrations for TAK-385||Up to Week 97 Day 1|The full analysis set included all participants who received at least 1 dose of study drug. The full analysis set where data at specified time points was available.|||ng/mL||Standard Deviation|Mean
2602509|NCT02141659|Secondary|Part B: Plasma Concentration of Unchanged TAK-385||Up to Week 49 Day 1|The PK evaluable population included participants who received at least 1 dose of study drug, without major protocol deviations, and met the minimum protocol prescription. The PK analysis population where data at specified time points was available.|||ng/mL||Standard Deviation|Mean
2602510|NCT02141659|Secondary|Part B: Percent Change From Baseline in PSA Levels on Week 13 Day 1 Last Observation Carried Forward (LOCF)||Baseline, and Week 13 Day 1 (LOCF; up to Week 13 Day 1)|The full analysis set included all participants who received at least 1 dose of study drug. The full analysis set where data at specified time points was available.|||percent change||Standard Deviation|Mean
2602511|NCT02141659|Secondary|Part A: Serum Testosterone Concentrations for TAK-385||Up to Day 35|The full analysis set included all participants who received at least 1 dose of study drug. The full analysis set where data at specified time points was available.|||ng/mL||Standard Deviation|Mean
2602512|NCT02141659|Secondary|Part A: AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to (Tau) Over the Dosing Interval for Unchanged TAK-385 on Day 1, 14 and 28||Days 1, 14 and 28 pre-dose and at multiple time points (up to 12 hours for Days 1 and 14; up to 72 hours for Day 28) post-dose|The PK evaluable population included participants who received at least 1 dose of study drug, without major protocol deviations, and met the minimum protocol prescription. The PK analysis population where data at specified time points was available.|||hour*nanogram per milliter (h*ng/mL)||Standard Deviation|Mean
2602513|NCT02141659|Secondary|Part A: Cmax: Maximum Observed Plasma Concentration for Unchanged TAK-385 on Day 1, 14 and 28||Days 1, 14 and 28 pre-dose and at multiple time points (up to 12 hours for Days 1 and 14; up to 72 hours for Day 28) post-dose|The pharmacokinetic (PK) evaluable population included participants who received at least 1 dose of study drug, without major protocol deviations, and met the minimum protocol prescription. The PK analysis population where data at specified time points was available.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2602514|NCT02141659|Primary|Part B: Number of Participants With Markedly Abnormal Values of ECG Parameters||From treatment initiation until 40 days after last dose of study drug (Day 712)|The safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2602515|NCT02141659|Primary|Part B: Number of Participants With Markedly Abnormal Values of Vital Signs Parameters|"Here BP is blood pressure."|From treatment initiation until 40 days after last dose of study drug (Day 712)|The safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2602722|NCT02139137|Primary|Change in Clinician Administered PTSD Scale; Re-experiencing|"Model estimations of the means and standard deviation of posttreatment score at the mean level of baseline severity reported below.~Scale range: 0-40, higher values indicate greater symptom severity"|Baseline, Week 4||||units on a scale||Standard Error|Mean
2602520|NCT02141659|Primary|Part A: Number of Participants With Grade 2 or Higher Laboratory Test Abnormalities|Laboratory test abnormalities were graded using the CTCAE. The grades were: Grade 2- (moderate) minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activity of daily living (ADL); Grade 3- (severe) medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care ADL. Data has been presented for any Grade 2 or higher event in the laboratory test abnormalities.|From treatment initiation until 40 days after last dose of study drug (Day 68)|The safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2602521|NCT02141659|Primary|Part A: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE)||From treatment initiation until 40 days after last dose of study drug (Day 68)|The safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2602522|NCT02141659|Primary|Part A: Number of Participants With Dose-limiting Toxicities (DLTs)|DLTs were defined as treatment-related adverse events (AEs) that occurred within the first 28 days of treatment as per common terminology criteria for adverse events (CTCAE) version 4.03: any grade 3 or higher toxicity; QT/Fridericia corrected QT (QTcF) greater than (>) 500 millisecond (msec) after treatment initiation; QT/QTcF interval prolongation >60 msec postdose.|From treatment initiation until Day 28|The DLT analysis set included all participants enrolled in cohort A that meeting the following; who had taken at least 80 percent (%) of the doses of TAK-385 (23 doses) during the DLT evaluation period and for whom the DLT evaluation period observations had been completed or who had experienced DLTs during the DLT evaluation period.|||Participants|||Count of Participants
2602523|NCT02141633|Secondary|Echocardiogram|to compare inhaled albuterol-induced changes in echocardiogram measuring mean pulmonary artery pressure (MPAP)in healthy current smokers and lifetime non-smokers as an index of endothelial function in the pulmonary circulation and to compare the results between smokers and non-smokers|MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers||||ΔMPAP (mmHg)||Standard Error|Mean
2602524|NCT02141633|Primary|Airway Blood Flow|compare inhaled albuterol-induced changes in airway blood flow (ΔQaw) in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway circulation and to compare the results between smokers and non-smokers|before and 15 minutes after albuterol inhalation||||ΔQaw (ul/min/ml)||Standard Error|Mean
2602525|NCT02141620|Secondary|Peak Temperature|Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||degrees Fahrenheit||Standard Error|Mean
2602526|NCT02141620|Secondary|Peak Heart Rate|Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||beats per minute||Standard Error|Mean
2602527|NCT02141620|Secondary|Peak Systolic Blood Pressure|Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||mm Hg||Standard Error|Mean
2602528|NCT02141620|Secondary|Peak Diastolic Blood Pressure|Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||mm Hg||Standard Error|Mean
2602529|NCT02141620|Secondary|"Peak Ratings of Talkative/Friendly on the Visual Analog Scale"|"Subjects rated their feelings of Talkative/Friendly on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602530|NCT02141620|Secondary|"Peak Ratings of Willing to Take Again on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Take Again on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602531|NCT02141620|Secondary|"Peak Ratings of Stimulated on the Visual Analog Scale"|"Subjects rated their feelings of Stimulated on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602532|NCT02141620|Secondary|"Peak Ratings of Sluggish/Fatigued/Lazy on the Visual Analog Scale"|"Subjects rated their feelings of Sluggish/Fatigued/Lazy on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602533|NCT02141620|Secondary|"Peak Ratings of Shaky/Jittery on the Visual Analog Scale"|"Subjects rated their feelings of Shaky/Jittery on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602534|NCT02141620|Secondary|"Peak Ratings of Rush on the Visual Analog Scale"|"Subjects rated their feelings of Rush on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602535|NCT02141620|Secondary|"Peak Ratings of Restless on the Visual Analog Scale"|"Subjects rated their feelings of Restless on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602536|NCT02141620|Secondary|"Peak Ratings of Performance Improved on the Visual Analog Scale"|"Subjects rated their feelings of Performance Improved on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602537|NCT02141620|Secondary|"Peak Ratings of Performance Impaired on the Visual Analog Scale"|"Subjects rated their feelings of Performance Impaired on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602538|NCT02141620|Secondary|"Peak Ratings of Willing to Pay For on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Pay For on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602539|NCT02141620|Secondary|"Peak Ratings of Nervous/Anxious on the Visual Analog Scale"|"Subjects rated their feelings of Nervous/Anxious on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602540|NCT02141620|Secondary|"Peak Ratings of Nauseous on the Visual Analog Scale"|"Subjects rated their feelings of Nauseous on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602541|NCT02141620|Secondary|"Peak Ratings of Like Drug on the Visual Analog Scale"|"Subjects rated their feelings of Like Drug on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602542|NCT02141620|Secondary|"Peak Ratings of Irregular/Racing Heartbeat on the Visual Analog Scale"|"Subjects rated their feelings of Irregular/Racing Heartbeat on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602543|NCT02141620|Secondary|"Peak Ratings of High on the Visual Analog Scale"|"Subjects rated their feelings of High on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602659|NCT02140411|Secondary|Number of Participants With Letters Gain / Loss at Week 52|Number of participants with letters correctly identified were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.|Baseline, Week 52|Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal|||Count of Participants|||Number
2602544|NCT02141620|Secondary|"Peak Ratings of Good Effects on the Visual Analog Scale"|"Subjects rated their feelings of Good Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602545|NCT02141620|Secondary|"Peak Ratings of Euphoric on the Visual Analog Scale"|"Subjects rated their feelings of Euphoric on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602546|NCT02141620|Secondary|"Peak Ratings of Bad Effects on the Visual Analog Scale"|"Subjects rated their feelings of Bad Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602547|NCT02141620|Secondary|"Peak Ratings of Any Effect on the Visual Analog Scale"|"Subjects rated their feelings of Any Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602548|NCT02141620|Secondary|"Peak Ratings of Active, Alert, Energetic on the Visual Analog Scale"|"Subjects rated their feelings of Active, Alert, Energetic on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602549|NCT02141620|Secondary|Peak Score on Stimulant Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Stimulant Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Stimulant Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602550|NCT02141620|Secondary|Peak Score on Sedative Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Sedative Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Sedative Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both n-acetylcysteine and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both n-acetylcysteine and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2602551|NCT02141620|Primary|Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative|The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects made 6 choices between available each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both buspirone and placebo maintenance.|One test per cocaine dose level per intervention for each participant over his/her approximate 2 week inpatient admission.||||Number of Cocaine Choices||Standard Deviation|Mean
2602552|NCT02141581|Other Pre-specified|Frequency of Vaccine-specific Antibody Secreting Cells on Day 5 and Day 7 After Vaccination||Baseline to Day 7|||||||
2602553|NCT02141581|Secondary|Number of Participants With Related Adverse Events|Number of participants with Related Adverse Events with a 0% Frequency Threshold|Baseline to Day 28||||Participants|||Count of Participants
2602554|NCT02141581|Primary|Number of Participants From Each Arm Who Received Influenza Vaccine||Baseline to Day 28||||Participants|||Count of Participants
2602555|NCT02141555|Secondary|Number of Participants Reporting 2 or 3 on a Scale of Medication Side Effects|"Assessment of medication side effects including: nausea, vomiting, headache, fever (over 100.4 F), dizziness, diarrhea, bad taste, dry mouth Did you experience any of these side effects? If so, how long did they last?~Patients asked on a scale of 0 to 3, where:~Side Effect scale:~0 = never~1= less than one day 2 = 1 to 2 days 3 = more than 2 days"|one week||||Participants|||Count of Participants
2602556|NCT02141555|Secondary|Number of Participants Who Answered 1 or 2 on a Scale of Satisfaction With the Procedure|"Written surveys patients will fill out at follow up visit assessing patient's satisfaction with the procedure.~How satisfied were you with your procedure?~The satisfaction scale used was:~1 =Very Satisfied, comfortable, likely to recommend 3= Neutral 5= Very unsatisfied/uncomfortable, unlike to recommend"|one week||||Participants|||Count of Participants
2602557|NCT02141555|Secondary|Number of Participants With Complete Abortion|Number of participants with complete abortion without surgical intervention defined as no evidence of a gestational sac on transvaginal ultrasound at the follow up visit.|one week||||Participants|||Count of Participants
2602558|NCT02141555|Primary|Patient Enrollment|The percentage of women who are offered enrollment and accept.|One year||||Participants|||Count of Participants
2602559|NCT02141516|Primary|Number Of Subjects With Unsolicited Adverse Events (AEs).|Safety was assessed as the number of subjects who reported unsolicited AEs collected from Day1 through Day 7 after any vaccination; serious adverse events (SAEs), AEs leading to withdrawal and medically attended AEs were collected throughout the study period (Day1-Day 91).|At Day1 through Day 7 after any vaccination and throughout the study period (Day 1 to Day 91)|Analysis was done on the Unsolicited Safety Set (all subjects in the exposed set with postvaccination unsolicited AE records).|||participants|||Number
2602560|NCT02141516|Secondary|Number of Subjects Reporting Solicited Local and Systemic AEs.|Reactogenicity was presented in terms of percentages of subjects reporting solicited local and systemic AEs and other indicators.|From Day 1 until Day 7 after any vaccination.|Analysis was done on Solicited Safety Set (all subjects in the exposed set with any solicited AE data).|||participants|||Number
2602561|NCT02141516|Primary|Percentage of Subjects With Four-fold Increases in ELISA Concentrations Against the Vaccine Antigen 287-953.|Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set|||Percentage of Subjects||95% Confidence Interval|Number
2602562|NCT02141516|Primary|ELISA GMRs of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.|Immune responses were measured as ELISA GMRs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set|||Ratios||95% Confidence Interval|Geometric Mean
2602563|NCT02141516|Primary|Geometric Mean Concentrations (GMCs) of Antibodies Against Vaccine Antigen 287-953 Following a 2-dose Vaccination Schedule.|Immune responses were measured as Enzyme-linked Immunosorbent Assay (ELISA) GMCs of antibodies against vaccine antigen 287-953 following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set|||IU/mL||95% Confidence Interval|Geometric Mean
2602564|NCT02141516|Primary|Percentages of Subjects With Four-fold Increases in hSBA Titers Against the Serogroup B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.|Antibody responses were assessed in terms of percentage of subjects achieving 4-fold increase in ELISA concentrations against vaccine antigen 287-953 on Day 91 over baseline (Day 1), following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set|||Percentage of Subjects||95% Confidence Interval|Number
2602565|NCT02141516|Primary|Geometric Mean hSBA Titers (GMTs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.|Immunogenicity was assessed in terms of GMTs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2602566|NCT02141516|Primary|Geometric Mean Ratios (GMRs) Against N. Meningitidis Serogroup B Strains Following a 2-dose Vaccination Schedule.|Immunogenicity was assessed in terms of GMRs against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set|||Ratios||95% Confidence Interval|Geometric Mean
2602567|NCT02141516|Primary|Percentages of Subjects With hSBA Titers ≥ 8 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.|Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 8 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+OMV NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine).|Analysis was done on Full Analysis Set|||Percentage of Subjects||95% Confidence Interval|Number
2602568|NCT02141516|Primary|Percentages of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Titers ≥ 5 for B Indicator Strains (H44/76, 5/99, and NZ98/254) and M10713 Strain.|Immunogenicity was assessed in terms of percentage of subjects with hSBA titers ≥ 5 against N. meningitidis serogroup B indicator strains (H44/76, 5/99, and NZ98/254) and M10713 strain following 2 doses of rMenB+Outer Membrane Vesicle (OMV) NZ, administered on Day 1 and Day 61.|Day 1 and Day 91 (one month after the second dose of the study vaccine)|Analysis was done on Full Analysis Set (all subjects in the enrolled set who: received a study vaccination and provided an evaluable serum sample at 1 month after the second dose of rMenB+OMV NZ, with assay result available for at least one of the serogroup B indicator strains or M10713 strain or ELISA).|||Percentage of Subjects||95% Confidence Interval|Number
2602569|NCT02141490|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and|Results are available for 39/43 subjects because 4 were screen failures.|||Participants|||Count of Participants
2602570|NCT02141490|Secondary|Percent Change in Signal Difference Within Metastatic Nodes in Prostate, Kidney, Bladder Cancer Patients at Ultrasonography|Patients will undergo ultrasound examination of imageable lymph nodes at pre-infusion, 24 hours and 48 hours. The signal changes at post-infusion ultrasound will be visually evaluated to determine if the uptake of ferumoxytol alters sonographic features.|pre-infusion, 24 hours and 48 hours|The analysis for this outcome measure was not done because most of the patients had deeply located lymph nodes and logistically ultrasonography analysis was not possible.||||||
2603262|NCT02134119|Secondary|Hematological Measures - Red Blood Cells|as measured by red blood cells (RBCs) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)||||M/uL||Standard Deviation|Mean
2602571|NCT02141490|Secondary|Percentage Change for Imaging (From Baseline to 48 Hours) Between Metastatic and Benign Nodes|Visible nodes were quantified with manually contoured regions of interest on axial T2*W MRI to obtain the mean signal intensity (SInode). The SI of the visible lymph node was normalized using the mean SI of the adjacent muscle tissue on the same slice (SImuscle). The following equation was used to obtain the normalized SI from the lymph node (SInormal): SInormal=SInode/SImuscle. The calculation formula was 100% * ((SInormal(48hrs)- SInormal(baseline))/ SInormal(baseline))). This image processing method was performed at baseline, 48-hours post-injection MRI studies to define the SI change differences between benign and malignant lymph nodes from baseline to 48 hours post-injection.|Baseline to 48 hours post injection|Results are available for 39/43 subjects because 4 were screen failures.|||Percent Change||95% Confidence Interval|Mean
2602572|NCT02141490|Primary|Percentage Change (From Baseline to 24 Hours) Between Metastatic and Benign Nodes|Visible nodes were quantified with manually contoured regions of interest on axial T2*W MRI to obtain the mean signal intensity (SInode). The SI of the visible lymph node was normalized using the mean SI of the adjacent muscle tissue on the same slice (SImuscle). The following equation was used to obtain the normalized SI from the lymph node (SInormal): SInormal=SInode/SImuscle. The calculation formula was 100% * ((SInormal(24hrs)- SInormal(baseline))/ SInormal(baseline)).This image processing method was performed at baseline, 24-hours post-injection MRI studies to define the SI change differences between benign and malignant lymph nodes from baseline to 24 hours post injection.|Baseline and 24 hours|Results are available for 39/43 subjects because 4 were screen failures.|||Percentage Change||95% Confidence Interval|Mean
2602573|NCT02141451|Secondary|Time to Progression|Time to relapse/progression in days|1 year|Only 3 participants experienced disease progression by 1 year on study|||days|||Number
2602574|NCT02141451|Secondary|Overall Survival|To evaluate 1 year overall survival|1 year||||Participants|||Count of Participants
2602575|NCT02141451|Secondary|Incidence of Serious Adverse Events|To determine incidence of serious adverse events|1 year||||Participants|||Count of Participants
2602576|NCT02141451|Primary|Number of Participants With Progression Free Survival at 6 Months|This primary end point will be estimated with Kaplan-Meier curves.|6 months||||Participants|||Count of Participants
2602577|NCT02141451|Primary|Number of Participants With Dose Limiting Toxicity Events|The Phase I design will continue until the MTD is declared or until the first dose is declared to be above MTD. Phase I dose limiting toxicity (DLT) is defined as Grade 3-5 non-hematologic, non-infectious toxicity including thromboembolic complications and select hematologic events including: grade 4 neutropenia lasting for ≥ 7 days, febrile neutropenia, grade 4 thrombocytopenia lasting ≥ 7 days despite dose delay or grade 3 thrombocytopenia associated with bleeding.|2 weeks||||Participants|||Count of Participants
2602578|NCT02141399|Primary|Incidence of Adverse Events (AEs)||Up to 56 weeks|The safety population included all subjects who received at least 1 dose of study drug.|||Participants|||Count of Participants
2602579|NCT02141360|Primary|mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software|To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including Volumetry, Kurtosis, Resting State [RS], functional magnetic resonance imaging [fMRI], and additional post-processing modules may be provided|Baseline to 3 months|Study was terminated and no subject outcome data were collected||||||
2602580|NCT02141295|Secondary|Cmax Accumulation Ratio (AR) of Vanucizumab|PK profile of vanucizumab was evaluated in terms of Cmax Ratio, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study.|Cycle 8|This endpoint was only reported for arms in which the participants received vanucizumab.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2602581|NCT02141295|Secondary|Volume of Distribution at Steady State (Vss) of Vanucizumab|PK profile of vanucizumab was evaluated in terms of Vss, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study.|Cycle 8|This endpoint was only reported for arms in which the participants received vanucizumab.|||ml||Geometric Coefficient of Variation|Geometric Mean
2602582|NCT02141295|Secondary|Plasma Clearance at Steady State (CLss) of Vanucizumab|PK profile of vanucizumab was evaluated in terms of CLss, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study.|Cycle 8|This endpoint was only reported for arms in which the participants received vanucizumab.|||ml/hr||Geometric Coefficient of Variation|Geometric Mean
2602583|NCT02141295|Secondary|Plasma Terminal Half-Life (t1/2) of Vanucizumab|PK profile of vanucizumab was evaluated in terms of t1/2, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study.|Cycle 8|This endpoint was only reported for arms in which the participants received vanucizumab.|||hr||Geometric Coefficient of Variation|Geometric Mean
2602584|NCT02141295|Secondary|Time to Reach Cmax (Tmax) of Vanucizumab|PK profile of vanucizumab was evaluated in terms of Tmax|Cycles 1 and 8 of parts 1 and 2|This endpoint was only reported for arms in which the participants received vanucizumab.|||hr||Full Range|Median
2602585|NCT02141295|Secondary|Minimum Observed Plasma Concentration (Clast) of Vanucizumab|PK profile of vanucizumab was evaluated in terms of Clast|Cycles 1 and 8 of parts 1 and 2|Data were collected and analyzed for the reported arms only.|||ug/ml||Geometric Coefficient of Variation|Geometric Mean
2602586|NCT02141295|Secondary|Maximum Observed Plasma Concentration (Cmax) of Vanucizumab|PK profile of vanucizumab was evaluated in terms of Cmax|Cycles 1 and 8 of parts 1 and 2|This endpoint was only reported for arms in which the participants received vanucizumab.|||ug/ml||Geometric Coefficient of Variation|Geometric Mean
2602587|NCT02141295|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) of Vanucizumab|PK profile of vanucizumab was evaluated in terms of AUC|Cycles 1 and 8 of parts 1 and 2|This endpoint was only reported for arms in which the participants received vanucizumab.|||hr*ug/ml||Geometric Coefficient of Variation|Geometric Mean
2602588|NCT02141295|Secondary|Number of Participants With Human Anti-human Antibodies (HAHAs) Against Vanucizumab|Safety is evaluated in terms of number of participants with Human Anti-human Antibodies (HAHAs) Against Vanucizumab.|End of study (EoS, within 28 to 42 days after last dose, latest at 29 months)|Endpoint includes only arms in which the participants received vanucizumab. n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.|||Participants|||Count of Participants
2602589|NCT02141295|Secondary|Percentage of Participants With Adverse Events (AEs)|Safety is evaluated in terms of percentage of participants with at least one serious adverse event and percentage of participants with at least one adverse event.|Up to approximately 29 months|n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.|||Percentage of Participants|||Number
2602590|NCT02141295|Secondary|Overall Survival (OS)|Efficacy of vanucizumab was evaluated in terms of OS as the time from randomization until death from any cause. 99999 = data not estimable due to the low number of deaths.|Baseline until death from any cause (maximum up to approximately 3.5 years)|This analysis was based on the ITT population, which consisted of all participants in the bevacizumab + mFOLFOX-6 and vanucizumab + mFOLFOX-6 arms. Participants in the safety-run in were not included.|||days||95% Confidence Interval|Median
2602591|NCT02141295|Secondary|Duration of Objective Response, as Assessed Using RECIST v. 1.1|Efficacy of vanucizumab was evaluated in terms of duration of objective response as assessed using RECIST v. 1.1. This was computed using the PFS definition with death on study (deaths that occurred outside the 30 days window from the last study treatment are excluded).|Baseline (within 28 days prior to Day 1), then every 8 weeks until PD, start of other anticancer therapy, withdrawal of consent, or death (up to approximately 29 months)|This analysis was based on the ITT population, which consisted of all participants in the bevacizumab + mFOLFOX-6 and vanucizumab + mFOLFOX-6 arms. Participants in the safety-run in were not included.|||days||95% Confidence Interval|Median
2602592|NCT02141295|Secondary|Percentage of Participants With Objective Response (ORR) as Assessed Using RECIST v. 1.1|Efficacy of vanucizumab was evaluated in terms of Percentage of Participants With ORR as Investigator-Assessed Using RECIST v. 1.1. Best Overall Confirmed Response.|Baseline (within 28 days prior to Day 1), then every 8 weeks until progressive disease (PD), start of other anticancer therapy, withdrawal of consent, or death (up to approximately 29 months)||||Percentage of Participants||95% Confidence Interval|Number
2602593|NCT02141295|Primary|Progression-free Survival (PFS), Time to Event|Efficacy of vanucizumab was evaluated in terms of PFS as Investigator-Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). PFS was defined as the time between randomization and the date of first documented disease progression or death from any cause on study, whichever occurred first. Death on study was defined as death from any cause within 30 days of the last study treatment.|Baseline, every 8 weeks, up to approximately 29 months|This analysis was based on the ITT population, which consisted of all participants who were randomized (Part II only) and received any amount of the study treatment (5 FU/folinic acid, oxaliplatin, bevacizumab, or vanucizumab) in the bevacizumab + mFOLFOX-6 and vanucizumab + mFOLFOX-6 arms. Participants in the safety-run in were not included.|||days||95% Confidence Interval|Median
2602594|NCT02141217|Secondary|Change From Baseline in Visual Analogue Scale Assessment of Swelling at Days 2, 5 and 7|Visual Analogue Scale (VAS) is used to measure the amount of swelling that the participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no swelling and 10 indicates worst possible swelling. Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7).|Baseline, Days 2, 5 and 7|ITT-E Population. Only those participants available indicated time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E population.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2602595|NCT02141217|Secondary|Change From Baseline in the Visual Analogue Scale Assessment of Pain Score at Days 2, 5 and 7|Visual Analogue Scale (VAS) is used to measure the amount of pain that the participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain. Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7).|Baseline, Days 2, 5 and 7|ITT-E Population. Only those participants available indicated time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E population.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2602596|NCT02141217|Secondary|Number of Participants (Par.) Achieving Clinical Success (CS) (Cure or Improvement [Imp] in Signs [s] and Symptoms [sx] [s/sx]) Without Considering Clinical (cl) Judgment (Jdg) of the Investigator (Inv) at Day 5|CS is defined as cure or imp in s/sx of odontogenic infections. Cure is defined as the complete resolution of s/sx of infection present at Baseline (BL) and imp is defined as resolution of fever (if present at BL), >70% reduction in swelling and pain and imp in other s/sx such that no additional antimicrobial (ant) therapy is required. In event of cure or imp with complete resolution of fever and >70% reduction in swelling and pain, but 'no change' or 'worsening from BL' in other s/sx (like increased leucocyte count/tooth mobility), the inv's opinion was sought on whether additional ant therapy was required. Par. that required no additional ant therapy were considered a 'success' while those requiring additional ant therapy were deemed a 'failure'. For a sensitivity analysis, all such par. with 'no change' or 'worsening from BL' in these other s/sx were considered as cl failures and termed 'Without Considering Cl Jdg of Inv', even though main s/sx are 'cured' or 'improved'. .|Day 5|ITT-E Population|||Participants|||Number
2602597|NCT02141217|Secondary|Number of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at Day 5|Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.|Day 5|ITT-E Population. Only the participants with Day 5 assessments were considered for analysis.|||Participants|||Number
2602660|NCT02140411|Secondary|Number of Participants Receiving Injections of Ranibizumab 0.5 mg Over a 48 Week Treatment Period.||Week 48|Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal|||Count of participants|||Number
2602598|NCT02141217|Primary|Percentage of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at the End of Treatment (Day 5 or Day 7)|Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.|Day 5 or Day 7 [End of treatment]|Intent-to-Treat (ITT) Population (randomized as per treatment allocation): all randomized participants who received at least one dose of study medication. If the post-Baseline assessment of clinical success response was missing then “Clinical Success” is considered as “No” i.e. the participant was treated as “Clinical Failure”.|||Percentage of participants|||Number
2602599|NCT02141217|Primary|Percentage of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at the End of Treatment (Day 5 or Day 7)|Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.|Day 5 or Day 7 [End of treatment]|Intent-To-Treat-Efficacy (ITT-E) Population: all participants in the ITT participants who had at least one post-Baseline assessment of clinical success response (clinical response based on assessment on odontogenic infection and VAS Score).|||Percentage of participants|||Number
2602600|NCT02141217|Primary|Percentage of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at the End of Treatment (Day 5 or Day 7)|Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain.|Day 5 or Day 7 [End of treatment]|Per-Protocol (PP) Population: all participants in the Intent-to-Treat (ITT) Population (defined as all randomized participants who received at least one dose of study medication) who were without major protocol violations and had end of treatment clinical response assessment available.|||Percentage of participants|||Number
2602601|NCT02140957|Secondary|Current Nighttime Bottle Use|Current nighttime bottle use.|2 years||||participants|||Number
2602602|NCT02140957|Secondary|Current Bottle Use|Current daytime bottle use.|2 years||||participants|||Number
2602603|NCT02140957|Primary|Change in Iron Depletion|Iron depletion (serum ferritin < 10 μg/L).|Baseline, 2 years||||percentage of participants|||Number
2602604|NCT02140788|Secondary|Changes in Total Scores on the 4 Positive Brief Psychiatric Rating Scale (BPRS) Items|The four positive items are: Suspiciousness, Unusual Thought Content, Hallucinations, Conceptual Disorganization.|baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.||||||
2602605|NCT02140788|Secondary|Changes in Mole Percentages of Omega-3 PUFAs in Fasting Serum and RBC Membranes||baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.||||||
2602606|NCT02140788|Secondary|Changes in C-reactive Protein and Sedimentation Rates||baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.||||||
2602607|NCT02140788|Secondary|Changes in Fasting Levels of Non-HDL Cholesterol and Triglycerides||baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.||||||
2602608|NCT02140788|Primary|Change in Weight||baseline, 2 weeks, 4 weeks|Patients were not randomized per protocol and the study was terminated. Data analysis was not performed.||||||
2602609|NCT02140775|Secondary|Behavioral Activation for Depression Scale (BADS)|"This 25 item scale total score is used to monitor change in Behavioral Activation (BA) protocols.~Score Range = 0 - 150 Higher scores suggest greater activation and less avoidance, as well as less social and work impairment."|BADS will be measured Follow-up (3-6 months after the end of counseling)|Not all participants completed the self-report measures at the Follow-up visit.|||units on a scale||Standard Deviation|Mean
2602610|NCT02140775|Secondary|Environmental Reward Observation Scale (EROS)|"This 10-item scale developed to assess changes in activity level and is based on the premise of response-contingent reinforcement.~Score Range = 10 - 40 Higher scores suggest higher environmental reward."|EROS will be measured at Follow-up (3-6 months after the end of counseling)|Not all participants completed the self-report measures at the Follow-up visit.|||units on a scale||Standard Deviation|Mean
2602619|NCT02140762|Secondary|Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.|"The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N.meningitidis serogroup B test strains, at 1 and 4 months after the 2-dose vaccination series.The 2-fold rise in titer is defined as follows:~a)for subjects with prevaccination hSBA titers <LLQ, a postvaccination hSBA ≥2 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 2 times of the prevaccination hSBA"|At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)|Analysis was performed on FAS immunogenicity- month 3 and month 6. The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Percentage of subjects||95% Confidence Interval|Number
2602611|NCT02140775|Primary|Goal Attainment Scale - Modified (GAS): Responder (Score of 3 - Goal Achieved) vs. Non-Responder (Score of 1 or 2 - Goal NOT Achieved)|"Goal Attainment Scale - Prior to the beginning of counseling, the patient met with a member of the clinical team to develop an outcome GAS scale specific to their personal return to work goal. A goal was carefully established to be obtainable within the framework of 3-6 months, and to have observable anchors that could be scored on 3 outcome levels. A score of 3 indicates that they achieved their predetermined work goal and they were considered a Responder to the counseling. A score 2 indicates that some of the specific steps were taken towards the goal, but that it was not fully achieved. A score of 1 indicates that few or no steps were taken. Participants who scored 1 or 2 on their GAS scale were considered to be Non-Responders.~The Primary outcome presented below includes the number of participants who achieved their work-related goal (a score on the GAS scale of 3) and are considered RESPONDERS to counseling."|GAS Goal Responder vs. Goal Non-Responder will be assessed at Follow Up (3-6 months after the end of counseling)||||Participants|||Count of Participants
2602612|NCT02140762|Secondary|Number of Subjects Reporting Unsolicited AEs.|Percentages of subjects reporting unsolicited AEs including serious adverse events (SAEs).|From day 1 to day 30 after any vaccination for any unsolicited AE. From day 1 to study termination (day 181) for all other categories.|Analysis was done on the unsolicited safety set, ie, all subjects in the exposed set with any unsolicited adverse event data and/or indicators of unsolicited adverse events. Analysis for AEs leading to withdrawal was done on All Enrolled Set population.|||Subjects|||Number
2602613|NCT02140762|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)|Reactogenicity was presented in terms of number of subjects reporting solicited local and systemic AEs and other indicators.|From day 1 (6 hours) until day 7 after any vaccination|Analysis was done on Solicited Safety Set: all subjects in the All Exposed Set who have provided any solicited adverse event data and/or other indicators or reactogenicity|||subjects|||Number
2602614|NCT02140762|Secondary|Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.|"The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a 4-fold rise in HT-hSBA titers against the N.meningitidis serogroups A,C,W and Y, at 1 and 4 months after the 2-dose vaccination series.~The 4-fold rise in titer is defined as follows:~a)for subjects with prevaccination hSBA titers <LLQ, a postvaccination hSBA ≥4 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 4 times of the prevaccination hSBA."|At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)|Analysis was performed on FAS immunogenicity- Month 3 and Month 6. The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Percentage of subjects||95% Confidence Interval|Number
2602615|NCT02140762|Secondary|Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A, C, W and Y at One and Four Months After the 2-dose Vaccination Series.|"The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a three-fold rise in HT-hSBA titers against the N.meningitidis serogroups A,C,W and Y at 1 and 4 months after the 2-dose vaccination series.~The 3-fold rise in titer is defined as follows:~a)for subjects with prevaccination hSBA titers <LLQ, a postvaccination hSBA ≥3 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 3 times of the prevaccination hSBA."|At Month 3 and Month 6 (one and four months after 2 doses of vaccination)|Analysis was performed on FAS immunogenicity-Month 3 and Month 6. The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Percentage of subjects||95% Confidence Interval|Number
2602616|NCT02140762|Secondary|Percentage of Subjects With 2-fold Rise in hSBA Titer Against N.Meningitidis Serogroups A,C,W and Y at One and Four Months After the 2-dose Vaccination Series.|"The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N.meningitidis serogroups A,C,W and Y, at 1 and 4 months after the 2-dose vaccination series.~The 2-fold rise in titer is defined as follows:~a)for subjects with prevaccination hSBA titers <LLQ, a postvaccination hSBA ≥2 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 2 times of the prevaccination hSBA."|At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)|Analysis was performed on FAS immunogenicity-Month 3 and Month 6. The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Percentage of subjects||95% Confidence Interval|Number
2602617|NCT02140762|Secondary|Percentage of Subjects With 4-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.|"The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a 4-fold rise in HT-hSBA titers against the N.meningitidis serogroup B test strains, at 1 and 4 months after the 2-dose vaccination series.~The 4-fold rise in titer is defined as follows:~a)for subjects with prevaccination hSBA titers <LLQ, a postvaccination hSBA ≥4 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 4 times of the prevaccination hSBA."|At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)|Analaysis was performed on FAS immunogenicity-Month 3 and Month 6. The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Percentage of subjects||95% Confidence Interval|Number
2602618|NCT02140762|Secondary|Percentage of Subjects With 3-fold Rise in hSBA Titer Against N.Meningitidis Serogroup B Strains at One and Four Months After the 2-dose Vaccination Series.|"The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a 3-fold rise in HT-hSBA titers against the N.meningitidis serogroup B test strains, at 1 and 4 months after the 2-dose vaccination series.The 3-fold rise in titer is defined as follows:~a)for subjects with prevaccination hSBA titers <LLQ, a postvaccination hSBA ≥3 LLQ; b) for subjects with a prevaccination hSBA titers ≥LLQ, an increase of at least 3 times of the prevaccination hSBA."|At Month 3 and Month 6 ( one and four months after 2 doses of vaccination)|Analysis was performed on FAS immunogenicity-month 3 and month 6. The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Percentage of subjects||95% Confidence Interval|Number
2602852|NCT02138097|Secondary|Treatment Discontinuation for United Healthcare Patients|Number of patients with a treatment gap of >=6 months (i.e., no dispensing of non-insulin hypoglycemic agents within 6 months after the end of days supplied)|up to 12 months|All subjects in United Healthcare cohort|||participants/1000 participant years|||Number
2602620|NCT02140762|Secondary|Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series|The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128, against serogroups A, C, W, Y, at one month after the 2-dose vaccination series.|One month after the second vaccination (month 3)|Analysis was done on the FAS immunogenicity (month 3). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Percentage of subjects||95% Confidence Interval|Number
2602621|NCT02140762|Secondary|Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at One Month After the 2-dose Vaccination Series|The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at one month after the 2-dose vaccination series, is reported.|One month after the second vaccination (month 3)|Analysis was done on the FAS immunogenicity (month 3). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Percentage of subjects||95% Confidence Interval|Number
2602622|NCT02140762|Secondary|Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series|The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroups A, C, W, Y at four months after the 2-dose vaccination series.|Four months after the second vaccination (month 6)|Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Percentage of subjects||95% Confidence Interval|Number
2602623|NCT02140762|Secondary|Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at Four Months After the 2-dose Vaccination Series.|The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at four months after the 2-dose vaccination series, is reported.|Four months after the second vaccination (month 6)|Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Percentage of subjects||95% Confidence Interval|Number
2602624|NCT02140762|Secondary|Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.|The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ LLQ against serogroups A, C, W, Y at four months after the 2-dose vaccination series.The LLQ cut off values for serogroups A,C,W and Y were 22.7,5.2,39.6 and 14.7 respectively.|Four months after the second vaccination (month 6)|Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Percentages of subjects||95% Confidence Interval|Number
2602625|NCT02140762|Secondary|Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Four Months After the 2-dose Vaccination Series.|The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ LLQ, at four months after the 2-dose vaccination series, is reported. The LLQ cut off values for strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6, 8.9, 8 and 8.2 respectively|Four months after the second vaccination (month 6)|Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||percentage of subjects||95% Confidence Interval|Number
2602626|NCT02140762|Secondary|Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y ≥ LLQ at Baseline and One Month After the 2-dose Vaccination Series|The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ against serogroups A, C, W, Y, at baseline(day 1) and one month after the 2-dose vaccination series.The LLQ cut off values for serogroups A,C,W and Y were 22.7,5.2,39.6 and 14.7 respectively.|At Baseline and One month after the second vaccination (month 3)|Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||percentage of subjects||95% Confidence Interval|Number
2602627|NCT02140762|Secondary|Percentages of Subjects With HT-hSBA Titers Against Serogroup B Test Strains ≥ Lower Limit of Quantitation (LLQ) at Baseline(Day 1) and One Month After the 2-dose Vaccination Series.|The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers against serogroup B test strains ≥ LLQ, at baseline(day 1) and one month after the 2-dose vaccination series, is reported. The LLQ cut off values for strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6, 8.9, 8 and 8.2 respectively.|At baseline(day 1) and One month after the second vaccination (month 3)|Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||percentage of subjects||95% Confidence Interval|Number
2602628|NCT02140762|Secondary|HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A, C, W, Y|The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs to serogroups A, C, W, and Y, at four months after the 2-dose vaccination series.|Four months after the second vaccination (month 6)|Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Titers||95% Confidence Interval|Geometric Mean
2602629|NCT02140762|Secondary|hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y|The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of hSBA GMTs to serogroups A, C, W, and Y, at one month after the 2-dose vaccination series.|One month after the second vaccination (month 3)|Analysis was done on FAS Immunogenicity (Month 3)|||Titers||95% Confidence Interval|Geometric Mean
2603428|NCT02132169|Secondary|Safety of AC 170 0.024% Compared to Its Vehicle|Safety measures (adverse events) of AC 170 0.024% compared to its vehicle were measured at Visit 1-4 and 5 (for subset of patients).|Up to 12 Weeks|Intent to Treat (ITT)|||adverse events|||Number
2602630|NCT02140762|Secondary|HT-hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains|The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs against serogroup B test strains, at four months after the 2-dose vaccination series.|Four months after the second vaccination (month 6)|Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Titers||95% Confidence Interval|Geometric Mean
2602631|NCT02140762|Secondary|hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroup B Test Strains|The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of hSBA GMTs against serogroup B test strains, at one month after the 2-dose vaccination series.|One month after the second vaccination (month 3)|Analysis was done on FAS Immunogenicity (Month 3). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Titers||95% Confidence Interval|Geometric Mean
2602632|NCT02140762|Secondary|Percentages of Subjects With Enc-hSBA Titer ≥ 1:4 and Enc-hSBA Titer ≥ 1:8 at Four Months After the 2-dose Vaccination Series|The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA ≥ 1:4 and enc-hSBA titer ≥ 1:8 against four N. meningitidis serogroup B test strains at four months after the 2-dose vaccination series is reported.|Four months after the second vaccination (month 6)|Analysis was done on the FAS immunogenicity (month 6). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Percentage of subjects||95% Confidence Interval|Number
2602633|NCT02140762|Secondary|Percentages of Subjects With Enc-hSBA Titer >= 1:4 and Enc-hSBA Titer >= 1:8 at One Month After the 2-dose Vaccination Series|The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA >= 1:4 and enc-hSBA titer >= 1:8 against four N. meningitidis serogroup B test strains at one month after the 2-dose vaccination series is reported.|One month after the second vaccination (month 3)|Analysis was done on FAS Immunogenicity (Month 3): all subjects in the All Enrolled Set who received a study vaccination, provided evaluable serum samples respectively at 1 month post-second vaccination (Visit Month 3) whose immunogenicity assay result is available for at least one N. meningitidis serogroup B test strain or serogroups A, C, W or Y.|||Percentage of Subjects||95% Confidence Interval|Number
2602634|NCT02140762|Secondary|Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject|The mean percentage of N. meningitidis serogroup B invasive disease strains killed by each subject, at 1:4 and 1:8 dilutions at four months after the 2-dose vaccination series is reported.|Baseline, four months after second vaccination (month 6)|Analysis was done on FAS effectiveness (month 6).|||Mean percentage of strains||Standard Deviation|Mean
2602635|NCT02140762|Secondary|Percentages of N. Meningitidis Serogroup B Invasive Disease Strains Killed at 1:4 and 1:8 Dilutions, for Each Subject|The mean percentage of N. meningitidis serogroup B invasive disease strains killed by each subject, at 1:4 and 1:8 dilutions at one month after the 2-dose vaccination series is reported.|Baseline, one month after second vaccination (month 3)|Analysis was done on FAS effectiveness (month 3)|||Mean percentages of strains||Standard Deviation|Mean
2602636|NCT02140762|Secondary|Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at Four Months After the Second Vaccination.|"The combined percentage of subjects without bactericidal activity at 1:8 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at four months after the second injection. The percentage of subjects without bactericidal activity at 1:8 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains.~Least Square (LS)-mean computed from the generalized linear model."|Four months after the second vaccination (month 6)|Analysis was done on FAS effectiveness (month 6).|||Percentage of subjects||Standard Deviation|Mean
2602637|NCT02140762|Secondary|Percentages of Subjects Without Bactericidal Activity at 1:8 Dilution Against Each US N. Meningitidis Serogroup B Strain at One Month After the Second Vaccination|"The combined percentage of subjects without bactericidal activity at 1:8 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:8 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains.~Least Square (LS)-mean computed from the generalized linear model."|One month after the second vaccination (month 3)|Analysis was done on FAS effectiveness ( month 3)|||Percentage of subjects||Standard Deviation|Mean
2602638|NCT02140762|Secondary|Percentages of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US N. Meningitidis Serogroup B Strain at 4 Months After the Second Vaccination.|"The combined percentage of subjects without bactericidal activity at 1:4 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at four months after the second injection. The percentage of subjects without bactericidal activity at 1:4 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains.~Least Square (LS)-mean computed from the generalized linear model."|Four months after the second vaccination (month 6)|Analysis was done on FAS effectiveness (month 6): All subjects in the All Enrolled Set who received a study vaccination and provided evaluable serum sample with enc-hSBA for at least one N. meningitidis serogroup B invasive disease strain at four months after the 2-dose series (Visit Month 6).|||Percentage of subjects||Standard Deviation|Mean
2602658|NCT02140411|Secondary|Change in Mean Visual Function Questionnaire (VFQ-25)|"Visual functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in visual functioning, while a negative change value indicates a worsening."|Baseline, week 48|Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal|||Score on a scale||Standard Deviation|Mean
2602639|NCT02140762|Primary|Percentage of Subjects Without Bactericidal Activity at 1:4 Dilution Against Each US Neisseria Meningitidis (N. Meningitidis) Serogroup B Strain at One Month After the Second Vaccination.|"The combined percentage of subjects without bactericidal activity at 1:4 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:4 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains.~Least Square (LS)-mean computed from the generalized linear model."|One month after the second vaccination (month 3)|Analysis was done on Full Analysis Set (FAS) effectiveness (month 3): all subjects in the All Enrolled Set who received a study vaccination and provided evaluable serum sample with enc-hSBA for at least one N. meningitidis serogroup B invasive disease strain at one month after the 2-dose series (Visit Month 3).|||Percentages of subjects||Standard Deviation|Mean
2602640|NCT02140645|Primary|Binary EMR Characteristic: Pancreatitis|"The missing EMR characteristic pancreatitis defined as participants with any note of prior pancreatitis.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic pancreatitis was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Percentage of participants|||Number
2602641|NCT02140645|Primary|Binary EMR Characteristic: Retinopathy|"The missing EMR characteristic retinopathy defined as participants with any note of diabetic retinopathy.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic retinopathy was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Percentage of participants|||Number
2602642|NCT02140645|Primary|Binary EMR Characteristic: Nephropathy|"The missing EMR characteristic nephropathy defined as participants with any note of diabetic nephropathy.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic nephropathy was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Upto 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Percentage of participants|||Number
2602643|NCT02140645|Primary|Binary EMR Characteristic: Neuropathy|"The missing EMR characteristic neuropathy defined as participants with any note of diabetic neuropathy.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic neuropathy was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Percentage of participants|||Number
2602644|NCT02140645|Primary|Missing EMR Characteristic: Diastolic BP|"The missing EMR characteristic diastolic BP defined as value in 6 months prior to and including index date.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic diastolic BP was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||mmHg||Standard Deviation|Mean
2602645|NCT02140645|Primary|Missing EMR Characteristic: Systolic BP (Blood Pressure)|"The missing EMR characteristic systolic BP defined as value in 6 months prior to and including index date.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic systolic BP was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||mmHg||Standard Deviation|Mean
2602646|NCT02140645|Primary|Missing EMR Characteristic: Total Cholesterol|"The missing EMR characteristic total cholesterol defined as value in 6 months prior to and including index date.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic total cholesterol was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||mg/dl||Standard Deviation|Mean
2602647|NCT02140645|Primary|Missing EMR Characteristic: eGFR (Glomerular Filtration Rate)|"The missing EMR characteristic eGFR defined as value in 6 months prior to and including index date.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic eGFR was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Upto 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||ml/min per 1.73 m^2||Standard Deviation|Mean
2602648|NCT02140645|Primary|Missing EMR Characteristic: HbA1c (Hemoglobin A1c (Glycosylated Hemoglobin))|"The missing EMR characteristic HbA1c defined as value in 6 months prior to and including index date.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic HbA1c was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Percentage||Standard Deviation|Mean
2602649|NCT02140645|Primary|Missing EMR Characteristic: BMI (Continuous)|"The missing EMR characteristic BMI is BMI value. Linear regression models were ran using a prioritized list of claims-based covariates as predictors and the value of select EMR-based clinical characteristics BMI as continuous outcomes.~The estimated value represented is actually prediction accuracy defined by R-squared."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Kg/m^2||Standard Deviation|Mean
2602650|NCT02140645|Primary|Missing EMR Characteristic: BMI (Body Mass Index)|"The missing EMR characteristic BMI defined as not obese, overweight, obese, severe obesity.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic BMI was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Percentage of participants|||Number
2602651|NCT02140645|Primary|Missing EMR Characteristic: Duration of Diabetes (Continuous)|"The missing EMR characteristic duration of diabetes defined as starting year/starting age of diabetes.~Linear regression models were ran using a prioritized list of claims-based covariates as predictors and the value of select EMR-based clinical characteristics duration of diabetes as continuous outcomes.~The estimated value represented is actually prediction accuracy defined by R-squared."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Months||Standard Deviation|Mean
2602652|NCT02140645|Primary|Missing EMR Characteristic: Duration of Diabetes|"The missing EMR characteristic duration of diabetes defined as >7, 5-6, 3-5, 1-3, <1 (in years) in duration.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic duration of diabetes was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Percentage of participants|||Number
2602653|NCT02140645|Primary|Missing EMR (Electronic Medical Record) Characteristic: Smoking|"The missing EMR characteristic smoking defined as current, unknown, versus past/never smoker.~The associations between claims-based covariates and missingness on EMR characteristics were investigated by estimating a logistic regression model (and multinomial logistic regression, depending on the number of categories for the EMR characteristic) for each EMR characteristic where an indicator for missing the EMR characteristic smoking was the dependent variable and all claims-based covariates were included as independent variables.~The estimated value represented is actually prediction accuracy defined by C-statistics."|Up to 20 months|All subjects in MarketScan cohort meeting inclusion/exclusion criteria. EMR-linked subset: From the study group we identified patients who have EMR data available.|||Percentage of participants|||Number
2602654|NCT02140593|Secondary|The Surgical Rating Score During Fascial Closure|After last suture of fascial closure surgical conditions are rated on a 5 point scale|Immediatly after fascial closure||||units on a scale||Full Range|Mean
2602655|NCT02140593|Primary|Surgical Rating Score|The final score for the surgical conditions of a patient defined as the average of all scores provided during the surgical procedure. (Rated on a 5 point subjective rating scale; 1: extremely poor, 2: poor, 3: acceptable, 4: good, 5: optimal)|After randomization every 30 minutes during the operation from first incision to last suture of fascial closure, up to 300 minutes||||units on a scale||Full Range|Median
2602656|NCT02140567|Primary|Specificity of the Syncope Prediction Algorithm|Number of tilt-negative participants identified as negative by the syncope prediction algorithm|Tilt Test with average duration of 1 hour|Number of participants with negative tilt-test|||Participants|||Count of Participants
2602657|NCT02140567|Primary|Sensitivity of the Syncope Prediction Algorithm|Number of tilt-positive participants predicted in the right way by the syncope prediction algorithm|Tilt Test with average duration of 1 hour|Number of participants with positive tilt-test|||Participants|||Count of Participants
2602780|NCT02138825|Primary|Mean Change in 6 Minute Walking Distance (6MWD) From Baseline to Week 26|The 6MWD test is designed to evaluate a patient's exercise capacity while performing an everyday activity.|Baseline to 26 weeks|Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication.|||Meter||Standard Deviation|Mean
2602661|NCT02140411|Secondary|Change Over Time of the Intraretinal Thickness in Optical Coherence Tomography (OCT)|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation, an increase in thickness as compared to baseline may indicate a progression of the underlying disease.|Baseline, week 48|Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal|||Microns||Standard Deviation|Mean
2602662|NCT02140411|Secondary|Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.|Baseline, Week 4, 8, 12, 24 and 36|Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal|||Letters||Standard Deviation|Mean
2602663|NCT02140411|Primary|Mean Change From Baseline in Best Correct Visual Acuity (BCVA)|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.|baseline, week 48|Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal.|||Letters||Standard Deviation|Mean
2602664|NCT02140372|Secondary|Platelet Adhesion: 2 Hours||2 hours||||percentage of adhered platelets||Inter-Quartile Range|Median
2602665|NCT02140372|Secondary|Platelet Adhesion: Baseline||Baseline||||percentage of adhered platelets||Inter-Quartile Range|Median
2602666|NCT02140372|Secondary|Light Transmission Aggregometry: 2 Hours|In response to adenosine epinephrine|2 hours||||percentage of max platelet aggregation||Inter-Quartile Range|Median
2602667|NCT02140372|Secondary|Light Transmission Aggregometry: Baseline|In response to adenosine epinephrine|baseline||||percentage of max platelet aggregation||Inter-Quartile Range|Median
2602668|NCT02140372|Secondary|Light Transmission Aggregometry: 2 Hours|In response to adenosine diphosphate|2 hours||||percentage of max platelet aggregation||Inter-Quartile Range|Median
2602669|NCT02140372|Primary|Monocyte Platelet Aggregate: 2 Hours||2 Hours||||percentage of monocyte-platelet aggregat||Inter-Quartile Range|Median
2602670|NCT02140372|Secondary|Light Transmission Aggregometry: Baseline|In response to adenosine diphosphate|Baseline||||percentage of max platelet aggregation||Inter-Quartile Range|Median
2602671|NCT02140372|Primary|Monocyte Platelet Aggregate: Baseline||Baseline||||percentage of monocyte-platelet aggregat||Inter-Quartile Range|Median
2602672|NCT02140164|Secondary|Number of Severe Adverse Events||Study Duration, up to 16 Months|All participants were included in the safety analysis.|||adverse events|||Number
2602673|NCT02140164|Secondary|Number of Non-ocular Adverse Events||Study Duration, up to 16 Months|All participants were included in the safety analysis.|||adverse events|||Number
2602674|NCT02140164|Secondary|Number of Ocular Adverse Events||Study Duration, up to 16 Months|All participants were included in the safety analysis.|||adverse events|||Number
2602675|NCT02140164|Secondary|Number of Study Eyes Achieving a 15-letter or More Worsening in Electronic Visual Acuity (EVA) at 12 Months as Compared to Baseline|Visual Acuity was measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method.|Baseline and 12 Months||||eyes|eyes||Number
2602676|NCT02140164|Secondary|Change in Visual Field as Measured by HVF 30-2 Visual Field Testing at 12 Months as Compared to the Average of Pre-treatment Values|Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the HVF 30-2 measurements at these three visits was used as the pre-treatment value.|Pre-treatment and 12 Months||||dB||Standard Deviation|Mean
2602677|NCT02140164|Secondary|Change in Visual Field as Measured by HVF 30-2 Visual Field Testing at 6 Months as Compared to the Average of Pre-treatment Values|Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the HVF 30-2 measurements at these three visits was used as the pre-treatment value.|Pre-treatment and 6 Months|Two participants had to switch to HVF 10-2; therefore they were not included in the analysis.|||dB||Standard Deviation|Mean
2602678|NCT02140164|Secondary|Change in Microperimetry at 12 Months as Compared to the Average of Pre-treatment Values|Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the microperimetry measurements at these three visits was used as the pre-treatment value.|Pre-treatment and 12 Months||||dB||Standard Deviation|Mean
2602679|NCT02140164|Secondary|Change in Microperimetry at 6 Months as Compared to the Average of Pre-treatment Values|Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the microperimetry measurements at these three visits was used as the pre-treatment value.|Pre-treatment and 6 Months||||decibels (dB)||Standard Deviation|Mean
2602680|NCT02140164|Secondary|Changes in Amplitude of Photopic and Scotopic Responses on Electroretinogram (ERG) Testing at 12 Months as Compared to the Average of Pre-treatment Values|This outcome measure will not be reported.|Pre-treatment and 12 Months|Participants had non-recordable ERGs; therefore, changes could not be measured.||||||
2602681|NCT02140164|Secondary|Changes in Amplitude of Photopic and Scotopic Responses on Electroretinogram (ERG) Testing at 6 Months as Compared to the Average of Pre-treatment Values|This outcome measure will not be reported.|Pre-Treatment and 6 Months|Participants had non-recordable ERGs; therefore, changes could not be measured.||||||
2602682|NCT02140164|Secondary|Change in Cystoid Macular Edema (CME) Based on Optical Coherence Tomography (OCT) Measurements in the Study Eye at 12 Months Compared to the Average of the Pre-treatment Values|Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the OCT measurements at these three visits was used as the pre-treatment value.|Pre-treatment and 12 Months||||microns||Standard Deviation|Mean
2602683|NCT02140164|Primary|Change in Cystoid Macular Edema (CME) Based on Optical Coherence Tomography (OCT) Measurements in the Study Eye at 6 Months Compared to the Average of the Pre-treatment Values.|Three visits (two pre-treatment and one baseline) were conducted prior to the receipt of investigational product (IP) and an average of the OCT measurements at these three visits was used as the pre-treatment value.|Pre-treatment and 6 Months|Participants receiving investigational product (IP) at the Month 6 visit were included in the primary efficacy analysis.|||microns||Standard Deviation|Mean
2602684|NCT02140060|Primary|Mean IOP at Week 6|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) was used for the analysis.|Week 6, 8 AM, 10 AM, 12 PM, 4 PM, and 8 PM|"This analysis population includes all subjects who were randomized, received study medication, and completed at least 1 scheduled on-therapy study visit, based upon a last on-therapy carried forward (LOCF) analysis. Here, n is the number of subjects with non-missing values at the specific time point for each arm, respectively."|||mmHg||Standard Error|Mean
2602685|NCT02139982|Primary|Changes in Cross-sectional Area of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)|The cross-sectional area(CSA, cm2) of Radial/ulnar Artery was assessed with B-mode imaging. Probe was kept perpendicular to the long axis of the artery to obtain the largest oval arterial section. The image at end diastole was chosen and measured with the cine loop.|baseline(t0), 30 min after specific nerve block(t1), 30 min after brachial plexus block(t2)||||cm^2||Standard Deviation|Mean
2602686|NCT02139982|Secondary|Changes in Skin Temperature From Baseline to 30min After Brachial Plexus Block(Phase 2)|Skin temperature was measured at the thenar. change= 30min after brachial plexus block minus baseline|Baseline,30 min after brachial plexus block||||℃||Standard Deviation|Mean
2602687|NCT02139982|Secondary|Success of Brachial Plexus Block ( Phase 2)|Success of Brachial Plexus Block(BPB) was defined as the absence of sensation to in all innervation areas of above four nerves (musculocutaneous, ulnar, radial, and median nerves) 30min. after the BPB and no pain during the surgery.|30 min after brachial plexus block||||participants|||Number
2602688|NCT02139982|Secondary|Changes in Skin Temperature From Baseline to 30 Min After Specific Nerve Block Followed by 30 Min After Brachial Plexus Block(Phase 1)|Skin temperature(Ts) was measured at four different points within the cutaneous innervation areas of the musculocutaneous(lateral skin of forearm), ulnar(hypothenar region), radial (thumb-index web) and median(thenar) Specific points were located with skin marker to provide consistency of measurement.|baseline, 30 min after specific nerve block, 30 min after brachial plexus block||||℃||Standard Deviation|Mean
2602689|NCT02139982|Primary|Changes in Hemodynamic Parameters of Brachial Artery From Baseline to 30min After Brachial Plexus Block(Phase 2)|"These parameters included peak systolic velocity (PSV, cm/s), end-diastolic velocity (EDV, cm/s), time average maximum velocity (TAMAX), resistance index (RI), and pulsatility index (PI),The cross-sectional area of the artery imaging.Blood flow (BF) = TAMAX× CSA×60s.~Relative ratio of hemodymanic parameter=30 min after brachial plexus block divide by baseline"|baseline, 30 min after brachial plexus block||||ratio||Inter-Quartile Range|Median
2602690|NCT02139982|Primary|Changes in Hemodynamic Parameters of Radial/Ulnar Artery From Baseline to 30min After Specific Nerve Block Followed by 30min After Brachial Plexus Block(Phase 1)|These parameters included peak systolic velocity (PSV, cm/s), end-diastolic velocity (EDV, cm/s), time average maximum velocity (TAMAX),and was measured by Pulsed-wave Doppler(PWD) ultrasound.|baseline(t0), 30 min after specific nerve block(t1), 30 min after brachial plexus block(t2)||||cm/s||Standard Deviation|Mean
2602691|NCT02139943|Primary|Percentage of Participants With Adverse Events||Up to 22 Weeks|Safety Analysis Set included all randomized participants who took at least 1 dose of double-blind study drug.|||percentage of participants|||Number
2602692|NCT02139943|Primary|Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight|Clinical response at Weeks 18 was assessed by the percentage of participants with Hemoglobin A1c (HbA1c) reduction greater than or equal to 0.4 % and had no increase in body weight.|Week 18|Modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of double-blind study drug. 'N (Number of Participants Analyzed)’ signifies participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2602693|NCT02139878|Secondary|Glucose|Plasma blood glucose concentrations|Up to 4 weeks||||mmol/L||Standard Error|Mean
2602694|NCT02139878|Primary|Blood Pressure|Systolic blood pressure|Up to 4 weeks||||mm Hg||Standard Error|Mean
2602695|NCT02139644|Secondary|Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 12 of the Treatment Period|Safety population|||Participants|||Count of Participants
2602714|NCT02139228|Primary|Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)|Immunogenicity was measured as geometric mean of Anti- PRP Concentrations, approximately 4 years after booster vaccination with either Hib-CRM197 or Hib-TT in children participating in previous V37_07E1 trial.|At Day 1 (4 years post booster dose administered in study V37_07E1)|Analysis was evaluated on the Per Protocol set (PPS)-All subjects in the All Enrolled Set with no reportable protocol deviations.|||Concentration in μg/mL||95% Confidence Interval|Geometric Mean
2602717|NCT02139176|Primary|Number of Women Who Came With Their Partners and Received Couple Counseling and Testing|Based on whether the female partner brings her male partner to the antenatal clinic for couple HIV counseling and testing (as recorded on study case report forms) as the primary measure of uptake. We will compare time to couple HIV counseling and testing between groups using the Kaplan Meier method and a log rank test.|three months||||Female participants receiving CHTC|||Number
2602696|NCT02139644|Secondary|Kaplan-Meier Estimates for Time to 15% and 12% Improvement From Baseline in FEV1 Postdose on Day 1|"A subset of approximately 300 patients who performed postdose serial spirometry is based on sample size calculation. Baseline FEV1 was the average of 2 FEV1 measurements (30 and 10 minutes predose) on Day 1. If one of these was missing, the other measurement was used as baseline value. If both were missing, baseline was treated as missing. Time to target improvement (15% or 12%) was defined as the time elapsed from the time of first dose to the first time the target improvement in FEV1 was achieved. If an exact target increase was not achieved at a measured timepoint, then the time was estimated by linear interpolation between the timepoint when target was reached and the timepoint immediately before. Patients who did not achieve the target improvement were censored at the time of last serial spirometry assessment.~Values of 9999 indicate the values could not be estimated which happened when the estimated probability of not achieving target is more than 50%."|Day 1 of the Treatment Period (predose and postdose)|Full analysis set: a subset of patients who performed postdose serial spirometry on Day 1|||hours||95% Confidence Interval|Median
2602697|NCT02139644|Secondary|Change From Baseline in the Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ(S)) Score at Endpoint for Patients >=18 Years Old|"The AQLQ(S) (September 2010 version; patients aged ≥18 years) was self-administered by the patients at the investigational center at the randomization visit and at Week 12 or end of trial. The questionnaire is a tool to measure the impact of asthma on a patient's quality of life (physical, emotional, social, and occupational) with a recall period of 2 weeks. The AQLQ(S) was administered only to patients 18 years and older. The 32 individual questions in the AQLQ were equally weighted. The overall AQLQ score was the mean of the responses to each of the 32 questions, and ranged from 1 to 7. A score of 7.0 indicated that the patient had no impairments due to asthma and a score of 1.0 indicated severe impairment.~Positive change from baseline scores indicate improved quality of life."|Day 1 (predose, baseline), end of trial (up to week 12)|FAS patients who contributed at least once to analysis and were >= 18 years old|||units on a scale||Standard Error|Least Squares Mean
2602698|NCT02139644|Secondary|Kaplan-Meier Estimate of Probability of Remaining in Study At Week 12|The analysis of probability of remaining in the study at Week 12 used the time to patient withdrawal for worsening asthma, defined as the number of days elapsed from the date of randomization to the date of withdrawal due to worsening asthma. Patients who were lost to follow-up, who had not withdrawn due to worsening asthma by week 12, or who had withdrawn due to reasons other than worsening asthma were right-censored at the date of last assessment.|up to Week 12 of the Treatment Period|FAS|||probability||95% Confidence Interval|Number
2602699|NCT02139644|Secondary|Change From Baseline in the Weekly Average of the Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol Over the 12-Week Treatment Period|Patients recorded the number of inhalations of rescue medication (albuterol/salbutamol HFA MDI) each AM and PM in the diary. The average number of daily inhalations over the 7 days before the randomization visit was the baseline value. The weekly average was based on the available data for the 7 days before each analysis week. The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using a mixed model for repeated measures.|Days -6 to Day 1 (predose, baseline), up to week 12|FAS of patients who contributed at least once to the analysis|||puffs||Standard Error|Least Squares Mean
2602700|NCT02139644|Secondary|Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over the 12-Week Treatment Period|"The total daily asthma symptom score is the average of the daytime and nighttime scores as recorded in the patient diary (range 0-9).~Daytime Symptom Score:~0=No symptoms~Symptoms for 1 short period~Symptoms for 2+ short periods~Symptoms for most of the day - did not affect normal daily activities~Symptoms for most of the day - did affect normal daily activities~Symptoms so severe that I could not go to work or perform normal daily activities~Nighttime Symptom Score (determined in the AM):~0=No symptoms~Symptoms causing me to wake once (or wake early)~Symptoms causing me to wake twice or more (including waking early)~Symptoms causing me to be awake for most of the night~Symptoms so severe that I did not sleep Baseline was the average of recorded scores over the 7 days before randomization. The change from baseline in the weekly average over weeks 1 to 12 was analyzed using an mixed model for repeated measures (MMRM)."|Days -6 to Day 1 (predose, baseline) to Week 12|Full analysis set of patients who contributed at least once to the analysis.|||units on a scale||Standard Error|Least Squares Mean
2602701|NCT02139644|Secondary|Change From Baseline in the Weekly Average of the Daily Morning Trough Peak Expiratory Flow (PEF) Over the 12 Week Treatment|Morning PEF tests were performed before administration of study drug or rescue medications (data were excluded if the time of PEF measurement was more than 5 minutes after the dose time). The patient recorded the highest value of 3 measurements obtained in the patient diary. The baseline PEF was the average value of recorded (nonmissing) morning assessments over the 7 days prior to randomization on Day 1. For efficacy analyses of weekly average morning PEF measurements, values were the averages based on available data for that week.|Days -6 to Day 1 (predose), Day 1 (postdose) daily until Week 12|Full analysis set of patients who contributed at least once to the analysis.|||liters/minute||Standard Error|Least Squares Mean
2602702|NCT02139644|Primary|Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12|"Trough FEV1 was a morning spirometry taken predose and pre-rescue bronchodilator. If the patient inadvertently administered asthma medication/study drug at home on the AM of the visit, or if the patient took rescue medication within 6 hours of testing, the visit was rescheduled.~The baseline for predose FEV1 was defined as the average of the 30-minute and 10-minute predose measurements obtained at the randomization visit (Day 1)."|Day 1 (predose, baseline), Week 12|Full analysis set|||liters||Standard Error|Least Squares Mean
2602715|NCT02139176|Secondary|Male Linkage to Care|It will be assessed whether newly diagnosed HIV-infected male partners are linked to care within one month of learning their HIV positive result with their partner. This will be assessed from abstraction of routine clinic records at Martin Preuss Center.|one month from male presentation to the clinic|These are only the HIV-infected men who participated in the study who were HIV-infected and not already engaged in care. That is why it is only a subset of the larger population.|||partners linked to care|||Number
2602716|NCT02139176|Secondary|Female First Option B+ Follow-up Visit|It will be assessed whether the female participants return for their first Option B+ visit (using the clinic's routine Option B+ records). The number retained will be compared.|three months||||participants|||Number
2602703|NCT02139644|Primary|Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours Postdose (FEV1 AUEC0-12h) at Week 12|"A subset of approximately 300 patients who performed postdose serial spirometry is based on sample size calculation. Data from these assessments were used to analyze the primary endpoint of baseline adjusted FEV1 AUEC0-12h at week 12 using the trapezoidal rule based on actual time of measurement. It was standardized by dividing it by the number of hours between the start time of dose administration and the end time of the last nonmissing FEV1 measurement.~The baseline FEV1 was the average of the 2 predose FEV1 measurements (30 and 10 minutes predose). If 1 of these was missing, the nonmissing value was used; if both were missing, baseline was treated as missing. Baseline-adjusted FEV1 was calculated as postdose FEV1 after subtracting the baseline FEV1 value."|Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hours|Full analysis set: a subset of patients who performed postdose serial spirometry at the baseline visit and week 12|||liters||Standard Error|Least Squares Mean
2602704|NCT02139592|Secondary|Overall Survival (OS)|OS is defined as the period from the start of therapy in standard medical care to the time when death (regardless of the cause of death) is confirmed. Reported data as OS was point estimates of 1 year survival rate for HL and ALCL participants.|Up to 30 months|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||Percentage of participants||95% Confidence Interval|Number
2602705|NCT02139592|Secondary|Percentage of Participants Who Achieve or Maintain Any Best Response|Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), complete response uncertain (CRu) (when no positron emission tomography [PET] data are available), and complete response (CR) after each cycle of treatment. Reported data are divided into 4 populations; Hodgkin's lymphoma (HL) participants with PET data, HL participants without PET data, anaplastic large cell lymphoma (ALCL) participants with PET data, and ALCL participants without PET data. PET is used in cancer diagnosis and treatment.|Up to Week 48 or until discontinuation of treatment|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percentage of participants||95% Confidence Interval|Number
2602706|NCT02139592|Primary|Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)||Up to Week 48 or until discontinuation of treatment|Safety Analysis Set; The safety analysis set was defined as all participants who had all of the required safety data defined on the protocol.|||Participants|||Count of Participants
2602707|NCT02139540|Secondary|Change in Quick Inventory of Depressive Symptomatology - Self Report - QIDS -SR|[Quick Inventory of Depressive Symptomatology - Self Report] An item-by-item severity scale of 0 to 3, with possible total scores ranging from 0 to 84. The items on the scale are added together for a total score. Higher scores mean worse outcome.|baseline and 24 hours||||score on a scale||95% Confidence Interval|Mean
2602708|NCT02139540|Primary|Change in Hamilton Depression Rating Scale HDRS-21|(21-point Hamilton Depression Rating Scale) Scoring is based on the first 17 items on the 21 point scale. Eight items are scored on a 5-point scale, ranging form 0=not present to 4= severe. Nine are scored from 0-2.|baseline and 24 hours||||score on a scale||95% Confidence Interval|Mean
2602709|NCT02139358|Secondary|Overall Survival (OS)|Median overall survival (in months) for all participants evaluable for response. The length of time from the start of treatment that participants are still alive.|Up to 36 months|All participants|||months||95% Confidence Interval|Median
2602710|NCT02139358|Secondary|Phase II: Progression Free Survival (PFS)|Median progression free survival (in months) for all participants evaluable for response. The time-to-event data will be summarized using Kaplan-Meir curve method for all patients who are evaluable for the ORR endpoint. Progressive disease (PD): At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the beginning of treatment or the appearance of one or more new lesions.|Up to 12 months|All participants|||months||95% Confidence Interval|Median
2602711|NCT02139358|Primary|Phase II: Objective Response Rate (ORR)|Objective Response Rate: Response according to Response Evaluation in Solid Tumors (RECIST) 1.1 for the combination of gemcitabine+trastuzumab+pertuzumab at the recommended phase II dose. Complete Response (CR): Disappearance of all evidence of tumor for at least two cycles of therapy. Tumor markers must be normal. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking a reference the baseline sum longest diameter. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the beginning of treatment or the appearance of one or more new lesions.|Up to 36 Months|All participants who have undergone 2 treatment cycles followed by a response scan and have documented best response data available.|||Participants|||Count of Participants
2602712|NCT02139358|Primary|Phase I: Recommended Phase II Dose (RP2D)|The RP2D dose in mg/m^2 of gemcitabine along with standard doses of pertuzumab (840 mg loading/420 mg maintenance) and Herceptin (8 mg/kg loading, 6 mg/kg maintenance). Safety data to be described using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 terminology. Any participant who receives any dose of the study treatment will be evaluated for the safety/toxicity endpoints in the trial.|6 Months|All participants enrolled during Phase 1|||dose in mg/m^2|||Number
2602713|NCT02139228|Secondary|Percentages of Subjects With Anti-PRP Concentrations ≥1.0 μg/mL and ≥0.15 μg/mL at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)|Immunogenicity was measured as the percentages of subjects with Anti-PRP Concentrations ≥1.0 μg/mL and ≥0.15 μg/mL approximately 4 years after booster vaccination with either Hib-CRM197 or Hib-TT in V37_07E1 trial.|At Day 1 (4 years post booster dose administered in study V37_07E1)|Analysis was evaluated on the Per Protocol set (PPS) (i.e. All subjects in the All Enrolled Set with no reportable protocol deviations).|||Percentage of subjects||95% Confidence Interval|Number
2620701|NCT01953328|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2602723|NCT02139124|Primary|Change From Baseline in Clinician-administered ADHD-5-Rating Scale Total Score|Participants were monitored for 4 weeks on treatment (final 2 weeks on stable dose). Clinicians rated subject behavior on the ADHD-5-Rating Scale each week. Primary outcome was based on the final week of treatment. The ADHD-5-RS is an 18-item questionnaire that measures the frequency of ADHD symptoms based on DSM-5 criteria. For each item, clinicians rate how often the behavior is displayed on a scale of 0 (Never or Rarely) to 3 (Very Often). Scores can range from 0 to 54, with lower scores indicating a lower frequency of ADHD symptoms.|4 weeks|The Full Analysis population consists of all randomized subjects who receive any amount of study medication and who have any ADHD-5-Rating Scale assessments.|||units on a scale||Standard Deviation|Mean
2602724|NCT02139046|Secondary|Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3||Month 3|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL.|||percentage of participants|||Number
2602725|NCT02139046|Secondary|Percentage of Participants With at Least One Gout Flare Requiring Treatment|"A participant was considered to have a gout flare if the following criteria were met:~Participant-reported acute particular pain typical of a gout attack that was deemed by participant and/or investigator to require treatment and was treated with colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids, Participant experienced at least 3 or more of: 1) Joint swelling, 2) Redness, 3) Tenderness, 4) Pain, Participant experienced at least one or more of: 1) Rapid onset of pain, 2) Decreased range of motion, 3) Joint warmth, 4) Other symptoms similar to a prior gout flare."|Baseline to Month 3|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
2602726|NCT02139046|Primary|Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3||Month 3|Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL.|||percentage of participants|||Number
2602727|NCT02139007|Secondary|Osteonecrosis of the Jaw|Patients self report diagnoses of osteonecrosis of the jaw 6 months post enrollment via follow-up survey .|Baseline to 6 months following enrollment||||Participants|||Count of Participants
2602728|NCT02139007|Secondary|Atypical Femoral Fracture|Patient reported fracture rate at 6 months after enrollment via follow-up survey|Baseline to 6 months following enrollment||||Participants|||Count of Participants
2602729|NCT02139007|Secondary|Clinical Fracture Rate|Patient reported fracture rate at 6 months following enrollment via survey.|Baseline to 6 months following enrollment||||Participants|||Count of Participants
2602730|NCT02139007|Primary|All Study Sites-Length of Time to 1st Participant Enrolled|Mean time from study initiation to 1st participant enrolled.|Length of time t for sites to recruit/enroll 1st participant|For sites enrolling at least one patient, the average (SD) time from contract execution to the first patient recruited.|||Months|Sites|Standard Deviation|Mean
2602731|NCT02139007|Primary|All Study Sites--Length of Time to Site IRB Approval|Mean time to gain site IRB approval|Length of time to site IRB approval||||Days|Sites|Standard Deviation|Mean
2602732|NCT02139007|Primary|All Study Sites--Length of Contracting Procedures|Mean time Between Clinical Site Recruitment and Contract Execution|Length of time Between Clinical Site Recruitment and Contract Execution|Nine sites from six states (AL, CO, NM, CT, CA, and PA) participated in this pilot study.|||Months|Sites|Standard Deviation|Mean
2602733|NCT02138916|Secondary|Immunogenicity of Benralizumab|Antidrug antibody (ADA) responses such as ADA prevalence, ADA incidence, ADA persistently positive counts, etc. were presented|Pre-treatment until end of follow-up, week 60 per protocol.|safety analysis set. For each parameter, the number of subjects at risk is to be analyzed.|||Participants|||Count of Participants
2602734|NCT02138916|Secondary|Serum Concentration of Benralizumab|PK serum samples were collected pre-dose at each visit.|Pre-first dose and pre-dose at end of treatment (week 56)|PK analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2602735|NCT02138916|Secondary|Duration of Study Treatment Administration|Duration of study treatment is calculated from first dose date to last dose date + 1 day.|From first dose date to last dose date, 48 weeks per protocol.|Safety analysis set|||Days||Standard Deviation|Mean
2602736|NCT02138916|Secondary|Number of Participants Had COPD-related Healthcare Encounter for Patient With Baseline EOS>=220/uL|Types of healthcare encounter: Hospitalisations (inc. intensive care and/or general care), Emergency department visits, Unscheduled outpatients visits, Home visits, Telephone calls, and ambulance transports.|Immediately following first IP up to week 56|Full analysis set, baseline EOS>=220/uL|||Participants|||Count of Participants
2602737|NCT02138916|Secondary|Annual COPD Exacerbation Rate Associated With ER or Hospitalization Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL|Annual COPD exacerbations rate that result in ER or hospitalization is calculated by number of exacerbations resulting ER or hospitalization divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model.|Immediately following first IP up to week 56|Full analysis set, baseline EOS>=220/uL|||Exacerbations per year||95% Confidence Interval|Least Squares Mean
2602738|NCT02138916|Secondary|Time to First COPD Exacerbation|Time to first COPD exacerbation is from the randomization date to the first occurrence of COPD exacerbation|Immediately following first IP up to week 56|Full analysis set, baseline EOS>=220/uL|||Days||95% Confidence Interval|Median
2602739|NCT02138916|Secondary|Number of Participants Having at Least 1 COPD Exacerbation for Patients With Baseline EOS>=220/uL|A COPD exacerbation is defined by symptomatic worsening COPD requiring systemic corticosteroids, antibiotics, or an inpatient hospitalization/death due to COPD.|Immediately following first IP up to week 56|Full analysis set, baseline EOS>=220/uL|||Participants|||Count of Participants
2602832|NCT02138136|Other Pre-specified|Median Monthly Score on a 4-point Pain Scale for Observed Abdominal Pain|Abdominal pain was rated on a scale from 1 (no pain) to 4 (very severe pain). A higher score means a worse outcome.|within 9 months|mITT with evaluable data at the given time point|||score on a scale||Full Range|Median
2621440|NCT01945944|Secondary|Dynamic Compliance|measured in ml/cm H20/kg using parameters on mechanical ventilator|during mechanical ventilation (typically 4 days - 2 weeks)||||mL/kg/cm-H20||Inter-Quartile Range|Median
2602740|NCT02138916|Secondary|Annual EXACT-PRO Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL|"The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while onsidering their experiences today. The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Annual EXACT-PRO exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model."|Immediately following first IP up to week 56|Full analysis set, baseline EOS>=220/uL|||Exacerbations per year||95% Confidence Interval|Least Squares Mean
2602741|NCT02138916|Secondary|Duration of EXACT-PRO for Patients With Baseline EOS>=220/uL|"The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while onsidering their experiences today. The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an event has occurred. Calculation of event duration after identification of the following five parameters: 1) onset; 2) three-day rolling average; 3) maximum observed value; 4) threshold for improvement; and 5) recovery. That is, duration of the exacerbation is the time elapse between onset and recovery of the event."|Immediately following first IP up to week 56|Full analysis set, baseline EOS>=220/uL|||Days||Standard Deviation|Mean
2602742|NCT02138916|Secondary|Severity of EXACT-PRO for Patients With Baseline EOS>=220/uL|"The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while onsidering their experiences today. The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Severity for the study is the highest score of EXACT-PRO."|Immediately following first IP up to week 56|Full analysis set, baseline EOS>=220/uL|||Score on a scale||Standard Deviation|Mean
2602743|NCT02138916|Secondary|Number of Participants by Number of COPD Exacerbations Based on EXACT-PRO for Patients With Baseline EOS>=220/uL|"The EXACT-PRO is a 14-item PRO instrument developed to assess the frequency, severity and duration of COPD exacerbations. Respondents are instructed to complete the electronic diary (eDiary) each evening just prior to bedtime and to answer the questions while onsidering their experiences today. The daily EXACT-PRO total score has a range of 0-100 with higher scores indicative of greater severity. Exacerbation event frequency is calculated by comparing the baseline with daily total scores. An increase in EXACT-PRO total score ≥9 for 3 days or ≥12 for 2 days indicate an exacerbation event has occurred."|Immediately following first IP up to week 56|Full analysis set, EOS>=220/uL|||Participants|||Count of Participants
2602744|NCT02138916|Secondary|Mean Change From Baseline in Proportion of Nights Awakenings Due to Respiratory Symptoms for Patients With Baseline EOS>=220/uL|Change from baseline to week 56 in proportion of nights awakenings due to respiratory symptoms.|First IP up to Week 56|Full analysis set, baseline EOS>=220/uL|||Proportion of nights||Standard Deviation|Mean
2602745|NCT02138916|Secondary|Mean Change From Baseline in Total Rescue Medication Use (Number of Puffs Per Day) for Patients With Baseline EOS>=220/uL|The number of rescue medication inhalations and nebulizer treatments taken are recorded by the patient in the eDiary twice daily. Total rescue medication use is the sum of daytime and night-time use.|First IP up to Week 56|Full analysis set, baseline EOS>=220/uL|||Puffs/day||Standard Deviation|Mean
2602746|NCT02138916|Secondary|Mean Change From Baseline in E-RS: COPD Total Score for Patients With Baseline EOS>=220/uL|The E-RS: COPD is an 11-item PRO developed to evaluate the severity of respiratory symptoms of COPD. Summation of E-RS: COPD item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity.|First IP up to Week 56|Full analysis set, baseline EOS>=220/uL|||Score on a scale||Standard Deviation|Mean
2602747|NCT02138916|Secondary|Mean Change From Baseline in CAT Total Score for Patients With Baseline EOS>=220/uL|CAT is an 8-item PRO developed to measure the impact of COPD on health status. The instrument uses semantic differential six-point response scales. A CAT total score is the sum of item responses. Score ranges from 0 to 40 with higher scores indicative of greater COPD impact on health status.|First IP up to Week 56|Full analysis set, baseline EOS>=220/uL|||Score on a scale||Standard Deviation|Mean
2602748|NCT02138916|Secondary|Mean Change From Baseline in SGRQ Total Score for Patients With Baseline EOS>=220/uL|SGRQ is from 50-item PRO instrument. The SGRQ total score is expressed as a percentage of overall impairment, in which 100% means the worst possible health status and 0 indicates the best possible health status.|First IP up to Week 56|Full analysis set, baseline EOS>=220/uL|||Percentage||Standard Deviation|Mean
2602749|NCT02138916|Secondary|Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline EOS>=220/uL|Pre-bronchodilator FEV1 (L) is collected at Weeks 0, 4, 8, 16, 24, 32, 40, 48, and 56. Baseline is the last non-missing value with quality (acceptable or borderline quality grade) prior to the first dose of study treatment.|First IP up to end of treatment Week 56|Full analysis set, baseline EOS>=220/uL|||Liter||Standard Deviation|Mean
2602750|NCT02138916|Secondary|Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS<220/uL|"A COPD exacerbation is defined by symptomatic worsening of COPD requiring:~Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or~Use of antibiotics; and/or~An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model."|From first IP to week 56|Full analysis set with baseline EOS<220/uL|||Exacerbations per year||95% Confidence Interval|Least Squares Mean
2622580|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 6||Week 6|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2602751|NCT02138916|Primary|Annual COPD Exacerbation Rate Over 56 Weeks Treatment Comparison for Patients With Baseline EOS>=220/uL|"A COPD exacerbation is defined by symptomatic worsening of COPD requiring:~Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or~Use of antibiotics; and/or~An inpatient hospitalization or death due to COPD Annual COPD exacerbation rate is the number of exacerbations per year. Its raw rate is calculated by number of exacerbations divided by the treatment period and then normalized to an annual rate, and is estimated by negative binomial model. Rate ratio between two treatment groups is also estimated through this model."|From first IP to week 56|Full analysis set with baseline EOS>=220/uL|||Exacerbations per year||95% Confidence Interval|Least Squares Mean
2602752|NCT02138890|Secondary|Role Emotional Measured With Short Form-36 (SF-36) Subscale Role Emotional Questionnaire at Day 1, 6 Months and 12 Months|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|12 Months|The 12 Month efficacy analyses were done on the mITT/PP analysis set.|||scores on a scale||Standard Deviation|Mean
2602753|NCT02138890|Secondary|Social Functioning Measured With Short Form-36 (SF-36) Subscale Social Functioning Questionnaire at Day 1, 6 Months and 12 Months|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|12 Months|The 12 Month efficacy analyses were done on the mITT/PP analysis set.|||scores on a scale||Standard Deviation|Mean
2602754|NCT02138890|Secondary|Vitality Measured With Short Form-36 (SF-36) Subscale Vitality Questionnaire at Day 1, 6 Months and 12 Months|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|12 Months|The 12 Month efficacy analyses were done on the mITT/PP analysis set.|||scores on a scale||Standard Deviation|Mean
2602755|NCT02138890|Secondary|General Health Measured With Short Form-36 (SF-36) Subscale General Health Questionnaire at Day 1, 6 Months and 12 Months|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|12 Months|The 12 Month efficacy analyses were done on the mITT/PP analysis set.|||scores on a scale||Standard Deviation|Mean
2602756|NCT02138890|Secondary|Bodily Pain Measured With Short Form-36 (SF-36) Subscale Bodily Pain Questionnaire at Day 1, 6 Months and 12 Months|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|12 Months|The 12 Month efficacy analyses were done on the mITT/PP analysis set.|||scores on a scale||Standard Deviation|Mean
2602757|NCT02138890|Secondary|Role Physical Measured With Short Form-36 (SF-36) Subscale Role Physical Questionnaire at Day 1, 6 Months and 12 Months|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|12 Months|The 12 Month efficacy analyses were done on the mITT/PP analysis set.|||scores on a scale||Standard Deviation|Mean
2602758|NCT02138890|Secondary|Mental Health Measured With Short Form-36 (SF-36) Subscale Mental Health Questionnaire at Day 1, 6 Months and 12 Months|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|12 Months|The 12 Month efficacy analyses were done on the mITT/PP analysis set.|||scores on a scale||Standard Deviation|Mean
2602759|NCT02138890|Secondary|Physical Functioning Measured With Short Form-36 (SF-36) Subscale Physical Functioning Questionnaire at Day 1, 6 Months and 12 Months|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. Eight subscales of the Short Form-36 questionnaire are used to derive Physical Component and Mental Component measures|12 Months|The 12 Month efficacy analyses were done on the mITT/PP analysis set.|||score on a scale||Standard Deviation|Mean
2602760|NCT02138890|Secondary|Quality of Life Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Quality of Life Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months|"The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions.~A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard."|12 months|The 12 Month efficacy analyses were done on the mITT/PP analysis set.|||score on a scale||Standard Deviation|Mean
2602761|NCT02138890|Secondary|Sports and Recreational (Sport/Rec) Activities Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Sport/Rec at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months|"The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions.~A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard."|12 months|The 12 Month efficacy analyses were done on the mITT/PP analysis set.|||scores on a scale||Standard Deviation|Mean
2602762|NCT02138890|Secondary|Function in Daily Living Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Function in Daily Living at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months|"The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions.~A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard."|12 months|The 12 Month efficacy analyses were done on the mITT/PP analysis set.|||scores on a scale||Standard Deviation|Mean
2602763|NCT02138890|Secondary|Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Symptoms at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months|"The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions.~A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard."|12 months|The 12 Month efficacy analyses were done on the mITT/PP analysis set.|||scores on a scale||Standard Deviation|Mean
2602764|NCT02138890|Secondary|Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months|"The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions.~A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard."|12 months|The 12 Month efficacy analyses were done on the mITT/PP analysis set.|||scores on a scale||Standard Deviation|Mean
2602765|NCT02138890|Secondary|Function on Daily Living Measured With WOMAC Subscale Questionnaire Physical Functioning at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months|"The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation.~The WOMAC Physical Functioning subscale consisted of seventeen questions scored from 0 to 4. The Physical Functioning has a range of 0 (no functional limitation) to 68 (maximal functional limitation)"|12 months|The 12 Month efficacy analyses were done on the mITT/PP analysis set.|||scores on a scale||Standard Deviation|Mean
2602766|NCT02138890|Secondary|Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months|"The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation.~The WOMAC Stiffness subscale consisted of two questions scored from 0 to 4. The Stiffness has a range of 0(no stiffness) to 8 (maximal stiffness)"|12 months|The 12 Month efficacy analyses were done on the mITT/PP analysis set.|||scores on a scale||Standard Deviation|Mean
2602767|NCT02138890|Secondary|Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months|The Visual Analogue Scale is a common tool for measuring general pain. A 100 mm line is marked from 0 to 10 in 10 mm increments. Knee pain severity is indicated by drawing a vertical mark at the point on the line that best represents the severity of pain. No pain is indicated by the 0 at the far left, and the worst possible pain is indicated by the 100 at the far right.|12 Months|The 12 Month efficacy analyses were done on the mITT/PP analysis set.|||scores on a scale||Standard Deviation|Mean
2602833|NCT02138136|Other Pre-specified|Median Monthly Score on a Stool Consistency Scale Associated With Observed SBMs|Stool consistency is rated on a 5-Point Stool Consistency Scale, where 1=normal and 5=very hard. Higher scores mean a worse outcome.|within 9 months|mITT with evaluable data at the given time point|||score on a scale||Full Range|Median
2602768|NCT02138890|Primary|Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months.|"The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation.~The WOMAC pain subscale consisted of five questions scored from 0 to 4. The pain has a range of 0 (no pain) to 20 (maximal pain)."|12 Months|This data describes mITT/PP analysis set|||scores on a scale||Standard Deviation|Mean
2602769|NCT02138890|Primary|Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6)|"The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation.~The WOMAC pain subscale consisted of five questions scored from 0 to 4. The pain has a range of 0 (no pain) to 20 (maximal pain)."|6 months|The safety/ITT population analysis population was utilized for this analysis.|||scores on a scale||Standard Deviation|Mean
2602770|NCT02138838|Secondary|Change in Serum Phosphorus From Baseline to the Mean Value During Weeks 17 to 20||Baseline and weeks 17 to 20|This analysis was conducted using the full analysis set using last value carried forward imputation. Participants with no post-baseline values available were excluded from the analysis.|||mg/dL||Standard Error|Least Squares Mean
2602771|NCT02138838|Secondary|Change in Corrected Serum Calcium From Baseline to the Mean Value During Weeks 17 to 20||Baseline and weeks 17 to 20|This analysis was conducted using the full analysis set using last value carried forward imputation. Participants with no post-baseline values available were excluded from the analysis.|||mg/dL||Standard Error|Least Squares Mean
2602772|NCT02138838|Secondary|Percent Change in iPTH From Baseline to the Mean Value During Weeks 17 to 20||Baseline and weeks 17 to 20|This analysis was conducted using the full analysis set using last value carried forward imputation. Participants with no post-baseline values available were excluded from the analysis.|||percent change||Standard Error|Least Squares Mean
2602773|NCT02138838|Secondary|Percentage of Participants Who Achieved a Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During Weeks 17 to 20||Efficacy assessment period, weeks 17 to 20|This analysis was conducted using the full analysis set. For participants with no iPTH values in the EAP, the mean of the last 2 available postbaseline values was used. If only 1 postbaseline value was available, this value was used. If no postbaseline value was available, the participant was considered a non-responder.|||percentage of participants|||Number
2602774|NCT02138838|Primary|Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline in Mean Plasma Intact Parathyroid Hormone During the Efficacy Assessment Period|"Intact parathyroid hormone (iPTH) levels were measured at weeks 17, 18, 19 and 20; the mean value from these measurements was calculated.~This endpoint was specified as the the primary endpoint in all countries except the United States (US). In the US this endpoint was specified as a secondary efficacy endpoint."|Baseline and the efficacy assessment period (EAP), weeks 17 to 20|The full analysis set (all randomized participants) was used for this analysis. For participants with no iPTH values in the EAP, the mean of the last 2 available postbaseline values was used. If only 1 postbaseline value was available, this value was used. If no postbaseline value was available, the participant was considered a non-responder.|||percentage of participants|||Number
2602775|NCT02138838|Primary|Percentage of Participants Who Achieved a ≥ 30% Reduction From Baseline In Mean Plasma iPTH During Weeks 11 to 15|"Intact parathyroid hormone (iPTH) levels were measured at weeks 11 and 15; the mean value from these 2 measurements was calculated.~This endpoint was the primary endpoint in the US only."|Baseline and weeks 11 to 15|The analysis was conducted using the full analysis set; participants who had no week 11 or 15 iPTH values were considered non-responders (non-responder imputation).|||percentage of participants|||Number
2602776|NCT02138825|Post-Hoc|Number of Serious Adverse Events During Safety Follow-up Phase|At the time of study termination, all participants entered safety follow-up phase regardless of whether they were in the main phase or in the LTE. Participants who had the End of Treatment visit prior to the implementation of the 120-day safety follow-up were followed-up for at least 30 days.|From start of safety follow-up phase until end of study|Safety analysis set: participants randomized and received at least one dose of study medication.|||Participants|||Number
2602777|NCT02138825|Post-Hoc|Number of Deaths Per Study Phase for Placebo Group|In the main study treatment phase participants received Placebo until 26 weeks. This phase was followed by a long-term extension (LTE) phase, during which participants were treated with Riociguat. At the time of study termination, all treated participants were taken off study drug and started the safety follow-up phase, regardless of whether they were in the main phase or in the LTE.|From start of treatment to end of study|Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication.|||Participants|||Number
2602778|NCT02138825|Post-Hoc|Number of Deaths Per Study Phase for Riociguat Group|In the main study treatment phase participants received Riociguat until 26 weeks. This phase was followed by a long-term extension (LTE) phase, during which participants continued with Riociguat treatment. At the time of study termination, all treated participants were taken off study drug and started the safety follow-up phase, regardless of whether they were in the main phase or in the LTE.|From start of treatment to end of study|Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication.|||Participants|||Number
2602779|NCT02138825|Secondary|Number of Participants With Clinical Worsening|"The combined endpoint time to clinical worsening, made up of the following components, defined by the first occurrence: all-cause mortality; need for hospitalization due to worsening cardiopulmonary (CP) status, attributable to progression of disease (including but not limited to increased shortness of breath or increased leg swelling); >15% decrease in the 6MWD test; worsening of WHO functional class."|From baseline to week 26|Intent to treat (ITT) analysis set: participants randomized and received at least one dose of study medication.|||Participants|||Number
2622581|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2602781|NCT02138786|Secondary|Duration of Progression Free Survival (PFS)|"Number of days calculated from date of start of study therapy to date of progression based on IWG criteria, or date of death if progression did not occur. Patients who dropped out prior to study end without evidence of disease progression were censored at the day they were last known to be alive. Patients without documented disease progression or recurrence were censored at the date of last disease assessment. Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.~."|Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.|Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.|||Days||95% Confidence Interval|Median
2602782|NCT02138786|Secondary|Percentage of Participants With Disease Control (Disease Control Rate)|Disease Control Rate (DCR) is defined as the percentage of patients who achieved CR, PR, or SD lasting for at least 8 weeks. CR was defined as disappearance of all evidence of disease. PR was defined as ≥ 50% regression of measurable disease and no new sites. SD was defined as failure to attain criteria for CR or PR, or to meet criteria for PD. Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.|Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.|Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.|||Percentage of participants||95% Confidence Interval|Number
2602783|NCT02138786|Primary|Number of Participants With Not Evaluable (NE) Response|Number of patients who could not be assessed quantitatively for disease response for any reason.|Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.|Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.|||Participants|||Count of Participants
2602784|NCT02138786|Primary|Number of Participants With Progressive Disease (PD)|Number of patients whose best overall response to study treatment was PD (any new lesion or increase by ≥ 50% of previously involved sites from nadir). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.|Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.|Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.|||Participants|||Count of Participants
2602785|NCT02138786|Primary|Number of Participants With Stable Disease (SD)|Number of patients whose best overall response to study treatment was SD (failure to attain criteria for CR or PR, or to meet criteria for PD). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.|Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.|Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.|||Participants|||Count of Participants
2602786|NCT02138786|Primary|Number of Participants With Partial Response (PR)|Number of patients whose best overall response to study treatment was PR (≥ 50% regression of measurable disease and no new sites). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.|Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.|Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.|||Participants|||Count of Participants
2602834|NCT02138136|Other Pre-specified|Median Monthly Score on a 5-point Straining Scale Associated With Observed SBMs|Straining during observed SBMs is rated on a 5-point scale where 1=no straining and 5=extreme straining. A higher value is worse.|within 9 months|mITT with evaluable data at the given time point|||score on a scale||Full Range|Median
2602835|NCT02138136|Primary|Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month|Spontaneous bowel movements are defined as bowel movements without the aid of drugs.|within 9 months|mITT with evaluable data at the given time point|||Weekly SBMs||Full Range|Median
2602787|NCT02138786|Primary|Number of Participants With Complete Response (CR)|Number of patients who achieved CR (complete disappearance of all detectable evidence of disease). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests.|Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.|Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.|||Participants|||Count of Participants
2602788|NCT02138786|Primary|Percentage of Participants With Overall Response (Overall Response Rate)|Overall Response Rate (ORR) is defined as the point estimate of the percentage of patients who have complete response (CR) or partial response (PR). Disease response was assessed using the International Working Group (IWG) Response Criteria for non-Hodgkin's lymphoma (Cheson 2007), including assessment of lymph node, spleen and liver lesions by PET (positron emission tomography) scan and assessment of bone marrow biopsies by morphologic, immunohistochemistry, and flow cytometry tests. CR was defined as disappearance of all evidence of disease, and PR was defined as ≥ 50% regression of measurable disease and no new sites.|Assessments were performed at Screening or Cycle 1/Day 1 prior to dosing and on Cycle 3/Day 1 and alternate cycles thereafter until disease progression, study drug intolerability had been reached, study withdrawal, or death.|Modified Intent to Treat (mITT) population, consisting of all patients who received at least one dose of selinexor and had at least one post-baseline efficacy evaluation. Patients without post-baseline efficacy follow-up information who discontinued the study due to toxicity, disease progression, or death were included in this population.|||Percentage of participants||95% Confidence Interval|Number
2602789|NCT02138747|Secondary|Number of Participants With Adverse Events|Safety was assessed by evaluation of treatment-emergent adverse events (TEAEs; frequency, severity, seriousness and relationship to study drug), AEs of special interest, vital signs (SBP, DBP, body temperature and pulse rate) and laboratory tests (liver function tests [LFTs]). Treatment-Emergent Adverse Event (TEAEs) were defined as any adverse event starting or worsening in the period from first dose of double-blind study drug until 15 days after last dose of double-blind study drug.|Baseline to EOT (Week 18) and follow up (Week 20)|Safety Analysis Set consisted of all participants who received at least 1 dose of double-blind study drug (SAF).|||Participants|||Number
2602790|NCT02138747|Secondary|Change From Baseline to End of Treatment (EOT) in Number of Micturitions Per 24 Hours||Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)|"Full Analysis Set (FAS) consisted of all randomized participants who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a post baseline visit.~Last observation carried forward imputation (LOCF) was utilized."|||Micturitions||Standard Error|Least Squares Mean
2602791|NCT02138747|Secondary|Change From Baseline to End of Treatment (EOT) in Mean Number of Incontinence Episodes Per 24 Hours||Baseline and EOT (Period 1-Week 8 and Period 2- Week 18)|Full Analysis Set Incontinence (FAS I) consisted of all participants in the FAS who had at least 1 incontinence episode in the baseline 3-day micturition diary and at least 1 postbaseline diary during period 1.Last observation carried forward imputation (LOCF) was utilized.|||Incontinence Episodes||Standard Error|Least Squares Mean
2602792|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Improvement in Day-to-Day Life Due to OAB Medication|Overall assessment of improvement in day-to-day life due to OAB medication was assessed on a scale from 1 to 5, with higher scores indicating greater improvement in day-to-day life due to current OAB medication.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.|||Units on a Scale||Standard Error|Mean
2602793|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Willingness to Continue OAB Medication|Overall assessment of willingness to continue OAB medication, was assessed on a scale from 1 to 5, with higher scores indicating greater desire to continue with current OAB medication.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.|||Units on a Scale||Standard Error|Mean
2602794|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Satisfaction With OAB Medication|Overall satisfaction with OAB medication was assessed on a scale of 1 to 5, with higher scores indicating greater satisfaction with current OAB medication.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.|||Units on a Scale||Standard Error|Mean
2602795|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Interruption of Day-to-Day Life Due to OAB|Overall assessment of interruption of day-to-day life due to OAB was assessed on a scale from 1 to 5, with higher scores indicating less interruption of day-to-day life due to OAB symptoms.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.|||Unit on a Scale||Standard Error|Mean
2602836|NCT02138110|Secondary|Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Spinal Cord Adhesion (Presence or Absence)|"Characteristics of spinal cord anatomy were assessed by a Board-certified neuroradiologist central reader including the presence or absence of spinal cord adhesion.~Screening MRI was used as the baseline value."|6 months post-implantation||||Participants|||Count of Participants
2622582|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2602796|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Overall Assessment of Participant's Fulfillment of OAB Medication Expectations|The final item score for overall assessment of patient's fulfillment of OAB medication expectations ranged from 1 to 5, with higher scores indicating better fulfillment of OAB medication expectations.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.|||Units on a Scale||Standard Error|Mean
2602797|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Satisfaction With OAB Control|Satisfaction with OAB control was scored from 0 to 100 with higher scores indicating greater satisfaction with OAB control.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.|||Units on a Scale||Standard Error|Mean
2602798|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: OAB Control|OAB control was scored from 0 to 100, with higher scores indicating better OAB control.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.|||Units on a Scale||Standard Error|Mean
2602799|NCT02138747|Secondary|Scale of the OAB-S Questionnaire at the End of Treatment Period: Impact on Daily Living With OAB.|Impact on daily living with the OAB was scored from 0 to 100, with higher scores indicating greater satisfaction with ability to perform daily activities.|Week 8 (End of Period 1) and Week 18 (End of Period 2)|Full Analysis Set (FAS) consisted of all randomized patients who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a post baseline visit. Last observation carried forward imputation (LOCF) was utilized.|||Units on a Scale||Standard Error|Mean
2602800|NCT02138747|Secondary|Participants Preference Based on a 5-Point Scale at the End of Period 2 in Participants Who Completed at Least 14 Days of Study Drug in Both Study Treatment Periods.|"Participants were asked to choose which treatment period they preferred and the degree of preference. Preference was assessed on a 5-point scale assessed at the end of period 2 (strong preference for period 1, mild preference for period 1, no preference, mild preference for period 2, strong preference for period 2). Participants who selected either a mild preference or strong preference were considered as having a preference for a specific study drug and participants who selected no preference were considered as having no preference for one study drug over the other study drug."|Week 18 (End of Period 2)|Full Analysis Set (FAS-PNP [Preference/No Preference]) consisted of all randomized participant who took at least 14 days of double-blind study drug in each treatment period and had filled out the patient preference form.|||Percentage of participants|||Number
2602801|NCT02138747|Primary|Participants Tolerability Assessed by the Medication Tolerability Scale of the Overactive Bladder-Satisfaction (OAB-S) Questionnaire at the End of Treatment (EOT)|The medication tolerability scale measured the level of bothersomeness related to the occurrence of a side effect that was known to be related to the approved OAB medication (i.e., constipation, dry mouth, drowsiness, headache, nausea and blurred vision). The OAB medication tolerability score was calculated as a sum of the responses and converted to a scale from 0 to 100, where higher score indicates better perceived OAB medication tolerability (less bother from side-effects).|Week 8 (End of Period 1) and Week 18 (End of Period 2)|The Full Analysis Set (FAS) comprised of all randomized participants who received at least 1 dose of double blind study drug and had filled out OAB-S tolerability scale at least once for a postbaseline visit. Last observation carried forward imputation (LOCF) was utilized.|||Units on a Scale||Standard Error|Least Squares Mean
2602802|NCT02138578|Secondary|Difference in Incidence of Treatment Related Pain Between SBRT and RFA Treatment Arms|All patients will be followed to assess the development of treatment related pain, and resultant usage of analgesics (drug classification and dosage) for treatment related pain. Incidence and severity of pain will be recorded for all patients, using the Common Terminology Criteria for Adverse Events (CTCAE), as will any resultant use of analgesics, and these will be compared between the two arms and analyzed in the non-randomized SBRT cohort.|Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment|Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured).||||||
2602803|NCT02138578|Secondary|Overall Survival Time||36 months post treatment|Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured).||||||
2602804|NCT02138578|Secondary|Metastasis Free Survival Time||36 months post treatment|Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured).||||||
2602805|NCT02138578|Secondary|Difference in Patient Time Away (Measured in Days) Between SBRT and RFA Treatment Arms|Patient time away from work/home secondary to treatment will be captured via patient questionnaire as a number of days and will be summarized descriptively by treatment group. Any differences between treatment groups will be tested by a two-sample t-test or nonparametric Mann-Whitney test.|Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment|Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured).||||||
2602964|NCT02137512|Secondary|Time Spent >180 mg/dL - Main Phase, Night Only|Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase, night only (23:00 to 07:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602806|NCT02138578|Secondary|Difference in Quality of Life (QOL) Scores Between SBRT and RFA Treatment Arms|QOL scores will be summarized descriptively by treatment at each time point using the Convalescence and Recovery Evaluation (CARE) and SF-12 quality of life assessments . Any differences between treatment groups will be tested in the context of a general linear model with terms for treatment, time, treatment time and possibly other patient level covariates that might explain QOL.|Pre-study, last day of treatment; 1, 3, 6, 12, 18, 24 and 36 months post treatment|Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured).||||||
2602807|NCT02138578|Primary|Cumulative Incidence of Grade 2 and Greater Toxicities|The number of patients reporting grade 2 and greater toxicities (for this trial the Common Terminology Criteria for Adverse Events or CTCAE was used).|up to 30 days after the last study treatment|Although no patients reported toxicity, the trial had poor accrual and patients were unable to be followed per protocol.|||Participants|||Count of Participants
2602808|NCT02138578|Primary|Proportion of Patients With Local Control of Disease|On imaging, local control will be defined as when the treated lesion shows no enhancement.|12 months|Due to changes in the planned scanning procedure during the trial, and feasibility for patients to undergo a diagnostic biopsy and baseline imaging and following imaging requiring contrast was deemed not possible, the trial close secondary to poor accrual and patients were unable to be followed per protocol (data points not captured).||||||
2602809|NCT02138461|Primary|Tolerability of Medications as Measured by the COMTOL Validated Instrument|Patients who are already taking the medications of interest will be enrolled from a general ophthalmology practice. Immediately after consenting to participate, they will complete a validated survey instrument called the Comparison of Ophthalmic Medication for Primary Outcome Measure Tolerability (COMTOL) questionnaire (Ophthalmology 1997; : 104:334-342). Because this study will not be a crossover trial design, and patients will only continue taking the medications they were prescribed in the course of their glaucoma therapy, the modified version will eliminate questions in the COMTOL related to subjective comparison of two medications and instead focus on tolerability of the single medication being taken by test subjects.|at the time of enrollment in the clinic, patients will immediately complete the questionnaire and exit the study||||percentage of patients|||Number
2602810|NCT02138253|Secondary|Ishak Modification of Knodell Histological Index - Portal Inflammation|"Portal inflammation~0 = None~1 = Mild, some or all portal areas~2 = Moderate, some or all portal areas~3 = Moderate/marked, all portal areas~4 = Marked, all portal areas"|24 months|Full analysis set|||Participants|||Count of Participants
2602811|NCT02138253|Secondary|Ishak Modification of Knodell Histological Index - Parenchymal Injury|"The Ishak modification of Knodell histological activity index will be determined by liver biopsy.~• parenchymal injury (focal lytic necrosis, apoptosis and focal inflammation)~0 = None~1 = One focus or less per 10× objective~2 = Two to four foci per 10× objective~3 = Five to ten foci per 10× objective~4 = More than ten foci per 10× objective"|24 months|Full analysis set|||Participants|||Count of Participants
2602812|NCT02138253|Secondary|Ishak Modification of Knodell Histological Index - Confluent Necrosis|"The Ishak modification of Knodell histological activity index will be determined by liver biopsy. The four items and their categorizations scores include:~• confluent necrosis~0 = None~1 = Focal confluent necrosis~2 = Zone 3 necrosis in some areas~3 = Zone 3 necrosis in most areas~4 = Zone 3 necrosis + occasional portal-central bridging~5 = Zone 3 necrosis + multiple portal-central bridging~6 = Panacinar or multiacinar necrosis"|24 months|Full analysis set|||Participants|||Count of Participants
2602813|NCT02138253|Secondary|Ishak Modification of Knodell Histological Activity Index - Interface Hepatitis|"The Ishak modification of Knodell histological activity index was determined by liver biopsy.~Interface hepatitis~0 = None~1 = Mild (local, few portal areas)~2 = Mild/moderate (focal, most portal areas)~3 = Moderate (continuous around <50% of tracts or septa)~4 = Severe (continuous around >50% of tracts or septa)"|24 months|Full analysis set|||Participants|||Count of Participants
2602814|NCT02138253|Secondary|flCK18/M65 Change From Baseline|Mechanistic biomarker of liver function|Baseline and 24 months|Full analysis set, the # of subject analyzed included subjects with an observed flCK18/M65 at 24 months.|||U/L||Standard Deviation|Mean
2602815|NCT02138253|Secondary|cCK18/M30 Change From Baseline|Mechanistic biomarker of liver function.|Baseline and 24 months|Full analysis set, the # of subject analyzed included subjects with an observed cCK18/M30 at 24 months.|||U/L||Standard Deviation|Mean
2602816|NCT02138253|Secondary|Caspase 3/7 Change From Baseline|Mechanistic biomarker of liver function|Baseline and 24 months|Full analysis set, the # of subject analyzed included subjects with an observed Caspase 3/7 at 24 months.|||Raw RLU||Standard Deviation|Mean
2602817|NCT02138253|Secondary|Aspartate Aminotransferase (AST) Change From Baseline|Liver function laboratory parameter|Baseline and 24 months|Full analysis set, the # of subject analyzed included subjects with an observed AST at 24 months.|||U/L||Standard Deviation|Mean
2602818|NCT02138253|Secondary|Alanine Aminotransferase (ALT) - Change From Baseline|Liver function laboratory parameter|Baseline and 24 months|Full analysis set, the # of subject analyzed included subjects with an observed ALT at 24 months.|||U/L||Standard Deviation|Mean
2602819|NCT02138253|Secondary|Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score|At least a one stage reduction from baseline in Ishak Fibrosis Stage. Score F0 No fibrosis F1 Fibrous expansion of some portal areas, with or without short fibrous septa F2 Fibrous expansion of most portal areas, with or without short fibrous septa F3 Fibrous expansion of most portal areas, with occasional portal to portal bridging F4 Fibrous expansion of portal areas, with marked bridging (portal to portal as well as portal to central) F5 Marked bridging (portal to portal and/or portal to central) with occasional nodules (incomplete cirrhosis) F6 Cirrhosis probable or definite|12 months|Full analysis set, the # of subject analyzed included subjects with an observed Ishak Fibrosis Score at 12 months.|||Participants|||Count of Participants
2602837|NCT02138110|Secondary|Number of Participants Stratified by Change From Baseline in Spinal Cord Anatomy - Cyst (Presence or Absence)|"Characteristics of spinal cord anatomy were assessed by a Board-certified neuroradiologist central reader including presence or absence of intraparenchymal cysts.~Screening MRI was used as the baseline value."|6 months post-implantation||||Participants|||Count of Participants
2602820|NCT02138253|Secondary|Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score (Observed Cases Only)|At least a one stage reduction from baseline in Ishak Fibrosis Stage. Score F0 No fibrosis F1 Fibrous expansion of some portal areas, with or without short fibrous septa F2 Fibrous expansion of most portal areas, with or without short fibrous septa F3 Fibrous expansion of most portal areas, with occasional portal to portal bridging F4 Fibrous expansion of portal areas, with marked bridging (portal to portal as well as portal to central) F5 Marked bridging (portal to portal and/or portal to central) with occasional nodules (incomplete cirrhosis) F6 Cirrhosis probable or definite|24 months|Full analysis set|||Participants|||Count of Participants
2602821|NCT02138253|Primary|Number of Participants With At Least a One Stage Reduction From Baseline in Ishak Fibrosis Score|"At least a one stage reduction from baseline in Ishak Fibrosis Stage. Score F0 No fibrosis F1 Fibrous expansion of some portal areas, with or without short fibrous septa F2 Fibrous expansion of most portal areas, with or without short fibrous septa F3 Fibrous expansion of most portal areas, with occasional portal to portal bridging F4 Fibrous expansion of portal areas, with marked bridging (portal to portal as well as portal to central) F5 Marked bridging (portal to portal and/or portal to central) with occasional nodules (incomplete cirrhosis) F6 Cirrhosis probable or definite~Since the primary analysis used multiple imputation methodology, the numerator and denominator varied across 20 imputations."|24 months|The Full Analysis Set (FAS) consisted of all randomized subjects who received at least 1 dose of study drug.|||participants|||Number
2602822|NCT02138240|Secondary|Median Weight at Follow up|Weight (kg) measured using standard methods|6 months||||kg||Inter-Quartile Range|Median
2602823|NCT02138240|Secondary|"Added Sugar Intake (Teaspoons/Day) Among Egos (Peer Educators) at Follow up"|Participants answered questions from the National Health Interview Survey (NHIS) 5-factor dietary screener, and relevant elements as recommended by NHIS were combined to estimate the daily added sugar intake (i.e.,soda, sugar-sweetened beverages, sweets and doughnuts). The American Heart Association recommends that all adults limit their added sugar intake to no more than 9 teaspoons per day.|6 months|Limited to Peer Educators|||teaspoons/day||Inter-Quartile Range|Median
2602824|NCT02138240|Secondary|"Added Sugar Intake (Teaspoons/Day) Among Alters (Sidekicks) at Follow up"|Participants answered questions from the National Health Interview Survey (NHIS) 5-factor dietary screener, and relevant elements as recommended by NHIS were combined to estimate the daily added sugar intake (i.e.,soda, sugar-sweetened beverages, sweets and doughnuts). The American Heart Association recommends that all adults limit their added sugar intake to no more than 9 teaspoons per day.|6 months|Limited to Sidekicks only|||teaspoons/day||Inter-Quartile Range|Median
2602825|NCT02138240|Primary|Added Sugar Intake (Teaspoons/Day) Among Total Sample at Follow up|Participants answered questions from the National Health Interview Survey (NHIS) 5-factor dietary screener, and relevant elements as recommended by NHIS were combined to estimate the daily added sugar intake (i.e.,soda, sugar-sweetened beverages, sweets and doughnuts). At 6 months, this measure ranged (min-max) from 9.1 to 56.0 teaspoons/day in this sample. The American Heart Association recommends that all adults limit their added sugar intake to no more than 9 teaspoons per day.|6 months||||teaspoons/day||Inter-Quartile Range|Median
2602826|NCT02138240|Primary|Participant's Likelihood to Recommend Program Assessed by 4-point Likert Scale|Survey question assesses willingness to recommend that a friend participate using a 4-point Likert scale (1 = Very likely; 2= Somewhat likely; 3 = Somewhat unlikely; 4 = Very unlikely). This is used to assess the program acceptability.|6 months||||Participants|||Count of Participants
2602827|NCT02138240|Primary|Participant Satisfaction as Assessed by 4-point Likert Scale|Survey question assesses participant satisfaction with the intervention using a 4-point Likert scale (1 = Very satisfied; 2= Somewhat satisfied; 3 = Somewhat dissatisfied; 4 = Very dissatisfied). This is used for the assessment of program acceptability.|6 months||||Participants|||Count of Participants
2602828|NCT02138240|Primary|Number of Sessions Attended|Number of sessions attended calculated from attendance sign-in sheets. This is used for the assessment of program feasibility.|3 months|Limited to Peer Educators who had the opportunity to attend the sessions.|||Number of sessions||Inter-Quartile Range|Median
2602829|NCT02138227|Secondary|Change in Request Staff's Comfort Answering Donation-related Questions During the Approach to Family Decision Makers|Requester staff self-report assessment utilizing a seven-point scale to rate his/her own comfort and satisfaction with the overall request process following each family contact. Due to the repeated measures design of the study and the high turnover rate among requesters, the number of participants in the post-intervention arms will not sum to those in the corresponding pre-intervention tenure level. The assessment was performed using a Likert scale ratin with a range of 1 to 7, with higher values representing better outcomes.|Baseline and continuously for 3 years post intervention||||units on a scale|Organ Donation Encounters|Standard Deviation|Mean
2602830|NCT02138227|Secondary|Change in Requesters' Aggregated Relational Communication Skills|Using a family interview, we will examine the family's experience with the donation process, specifically focusing on family self-report of comfort, satisfaction with the communication and decision-making process, content of the conversation, and measurement of the relational aspects of the communication. The instrument is based on a well-developed interview that was used in a seminal study of family experience and decision-making for organ donation in acute care hospital settings. Due to the repeated measures design of the study and the high turnover rate among requesters, the number of participants in the post-intervention arms will not sum to those in the corresponding pre-intervention tenure level. The aggregate scores of fourteen (14) 7-point scale items with an aggregate range of 14 to 98. Higher values represent a better outcome.|Baseline and continuously for 3 years post intervention||||units on a scale|Total organ donation approach encounters|Standard Deviation|Mean
2602831|NCT02138227|Primary|Change in Authorization Rates for Solid Organ Donation From Families of Donor-eligible Patients|OPO requesters completed a brief, web-based survey after every family approach, regardless of whether the family ultimately consented to donation. Rates of baseline and post-intervention consent to donation were compared. Due to the repeated measures design of the study and the high turnover rate among requesters, the number of participants in the post-intervention arms will not sum to those in the corresponding pre-intervention tenure level.|Baseline and continuously for 3 years post intervention||||Percentage of successful requests|Total organ donation approach encounters||Number
2622583|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 1||Week 1|Full Analysis Set|||percentage of participants|||Number
2602838|NCT02138110|Secondary|Change From Baseline in ISNCSCI Total Motor Score|"International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Total Motor Scores were assessed on a scale from 0 to 5 for each myotome tested on each side of the body (upper limb maximum score = 50 and lower limb maximum score = 50), with higher scores indicating better neurologic function.~The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit.~An improvement in motor score indicates an increase in motor score from baseline at 6-months A deterioration in motor score indicates an decrease in motor score from baseline at 6-months No change in motor score indicates no change in motor score from baseline at 6-months"|6 months post-implantation|Results from 15 of 16 patients are presented. This is because pre-implantation assessment was not testable for 1 of 16 patients.|||Participants|||Count of Participants
2602839|NCT02138110|Secondary|Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Light Touch Score|"International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sensory Light Touch Scores were assessed on a scale from 0 to 2 for each sensory point tested on each side of the body (maximum score = 112), with higher scores indicating better neurologic function.~The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit.~An improvement in light touch score indicates an increase in light touch score from baseline at 6-months A deterioration in light touch score indicates a decrease in light touch score from baseline at 6-months No change in light touch score indicates no change in light touch score from baseline at 6-months"|6 months post-implantation||||Participants|||Count of Participants
2602840|NCT02138110|Secondary|Number of Participants Stratified by Change From Baseline in ISNCSCI Sensory Pin Prick Score|"International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Sensory Pin Prick Scores were assessed on a scale from 0 to 2 for each sensory point tested on each side of the body (maximum score = 112), with higher scores indicating better neurologic function.~The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit.~An improvement in pin prick score indicates an increase in score from baseline at 6-months A deterioration in pin prick score indicates a decrease in score from baseline at 6-months No change in pin prick score indicates no change in score from baseline at 6-months"|6 months post-implantation||||Participants|||Count of Participants
2602841|NCT02138110|Secondary|Number of Participants Stratified by Change From Baseline in Neurological Level of Injury (NLI) at 6 Months|"The neurological level of injury (NLI) refers to the most caudal segment of the spinal cord with normal sensory and antigravity motor function on both sides of the body, provided that there is normal (intact) sensory and motor function rostrally.~A caudal change is an improvement in NLI whereas a rostral change is a deterioration in NLI.~The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit."|6 months post-implantation||||Participants|||Count of Participants
2602842|NCT02138110|Primary|Percentage of Patients With Improvement in AIS Grade of One or More Levels|"The ASIA (American Spinal Injury Association) Impairment Scale (AIS) classifies spinal cord injuries as follows:~A = Complete: no sensory or motor function is preserved in the sacral segments S4-S5~B = Sensory incomplete: sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5, AND no motor function is preserved more than three levels below the motor level on either side of the body~C = Motor incomplete: motor function is preserved below the neurological level, and more than half of key muscle functions below the single neurological level of injury have a muscle grade less than 3 (Grades 0-2)~D = Motor incomplete: at least half (half or more) of key muscle functions below the NLI have a muscle grade >3~E = Normal~The confirmatory ISNCSCI exam performed within 8 hours prior to surgery was used as the baseline visit."|6 months post-implantation|The Primary Endpoint Analysis Set includes all subjects who had a successful Neuro-Spinal Scaffold implant, no major data protocol deviations, and completed the 6-month Primary Endpoint Follow-up Visit.|||percentage of patients|||Number
2602843|NCT02138097|Secondary|Persistence at 12 Months for MarketScan Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 12 months. Grace period of 30 days will be allowed.|12 months|All patients in MarketScan cohort|||Percentage of participants|||Number
2602844|NCT02138097|Secondary|Persistence at 6 Months for MarketScan Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 6 months. Grace period of 30 days will be allowed.|6 months|All patients in MarketScan cohort|||Percentage of participants|||Number
2602845|NCT02138097|Secondary|Persistence at 3 Months for MarketScan Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 3 months. Grace period of 30 days will be allowed.|3 months|All patients in MarketScan cohort|||Percentage of participants|||Number
2602846|NCT02138097|Secondary|Persistence at 12 Months for United Healthcare Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 12 months. Grace period of 30 days will be allowed.|12 months|All patients in United Healthcare cohort|||Percentage of participants|||Number
2602847|NCT02138097|Secondary|Persistence at 6 Months for United Healthcare Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 6 months. Grace period of 30 days will be allowed.|6 months|All patients in United Healthcare cohort|||Percentage of participants|||Number
2602848|NCT02138097|Secondary|Persistence at 3 Months for United Healthcare Patients|Fraction of non-insulin hypoglycemic initiators with continued dispensing. Patients will be classified as persistent if they possess medication at 3 months. Grace period of 30 days will be allowed.|3 months|All patients in United Healthcare cohort|||Percentage of participants|||Number
2602849|NCT02138097|Secondary|Proportion of Days Covered for MarketScan Patients|Number of days supply dispensed divided by number of days followed|up to 12 months|All patients in MarketScan cohort|||days covered||Standard Deviation|Mean
2602850|NCT02138097|Secondary|Proportion of Days Covered for United Healthcare Patients|Number of days supply dispensed divided by number of days followed|up to 12 months|All patients in United Healthcare cohort|||days covered||Standard Deviation|Mean
2602851|NCT02138097|Secondary|Treatment Discontinuation for Marketscan Patients|Number of patients with a treatment gap of >=6 months (i.e., no dispensing of non-insulin hypoglycemic agents within 6 months after the end of days supplied)|up to 12 months|All subjects in Marketscan cohort|||participants/1000 participant years|||Number
2602853|NCT02138097|Primary|Subsequent Insulin Initiation for MarketScan Patients|Number of patients filling an insulin prescription subsequently to initiation of the original non-insulin agent without having filled one in the past 6 months|up to 12 months|All patients in MarketScan cohort|||participants/1000 participant years|||Number
2602854|NCT02138097|Primary|Subsequent Insulin Initiation for United Healthcare Patients|Number of patients filling an insulin prescription subsequently to initiation of the original non-insulin agent without having filled one in the past 6 months|up to 12 months|All patients in United Healthcare cohort|||participants/1000 participant years|||Number
2602855|NCT02138097|Primary|Treatment Augmentation for MarketScan Patients|Number of patients dispensing of a new non-insulin hypoglycemic agent while continuing to fill prescriptions for the initial therapy|up to 12 months|All patients in MarketScan cohort|||participants/1000 participant years|||Number
2602856|NCT02138097|Primary|Treatment Augmentation for United Healthcare Patients|Number of patients dispensing of a new non-insulin hypoglycemic agent while continuing to fill prescriptions for the initial therapy|up to 12 months|All patients in United Healthcare cohort|||participants/1000 participant years|||Number
2602857|NCT02138097|Primary|Treatment Switching for MarketScan Patients|Number of patients with dispensing of a new non-insulin hypoglycemic agent without subsequent to the end of days' supply of the original agent plus 30 days|up to 12 months|All subjects in MarketScan cohort|||participants/1000 participant years|||Number
2602858|NCT02138097|Primary|Treatment Switching for United Healthcare Patients|Number of patients with dispensing of a new non-insulin hypoglycemic agent without subsequent to the end of days' supply of the original agent plus 30 days|up to 12 months|All subjects in United Healthcare cohort|||participants/1000 participant years|||Number
2602859|NCT02138097|Primary|Proportion of Initiators for MarketScan Patients|Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent.|up to 12 months|All subjects in MarketScan cohort|||Percentage of participants|||Number
2602860|NCT02138097|Primary|Proportion of Initiators for United Healthcare Patients|Number of patients initiating each individual agent divided by the number of patients initiating any oral or non-insulin injected hypoglycemic agent.|up to 12 months|All subjects in the United Healthcare cohort|||Percentage of participants|||Number
2602861|NCT02138006|Secondary|Morbidity of Cardiovascular Complications|Morbidity of: coronary heart disease, stroke and renal failure|Up to 28 years||||participants|||Number
2602862|NCT02138006|Primary|Cardiovascular Mortality|All cause mortality and composite mortality from myocardial infarction, stroke and renal failure|Up to 28 years||||participants|||Number
2602863|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|12 Weeks after PDT #1|ITT|||participants|||Number
2602864|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|8 Weeks after PDT #1|ITT|||participants|||Number
2602865|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|4 Weeks after PDT #1|ITT|||participants|||Number
2602866|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|2 Weeks after PDT #1|ITT|||participants|||Number
2602867|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24-48 hours after PDT #1|ITT|||participants|||Number
2602868|NCT02137785|Other Pre-specified|Oozing/Vesiculation/Crusting|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline|ITT|||participants|||Number
2602965|NCT02137512|Secondary|Time Spent >180 mg/dL - Main Phase, Day and Night|Percentage of CGM Measured Glucose Values >180 mg/dl during study Main Phase|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602869|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|12 Weeks after PDT #1|ITT|||participants|||Number
2602870|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|8 Weeks after PDT #1|ITT|||participants|||Number
2602871|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|4 Weeks after PDT #1|ITT|||participants|||Number
2602872|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|2 Weeks after PDT #1|ITT|||participants|||Number
2602873|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24-48 hours after PDT #1|ITT|||participants|||Number
2602874|NCT02137785|Other Pre-specified|Scaling & Dryness|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline|ITT|||participants|||Number
2602875|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|12 Weeks after PDT #1|ITT|||participants|||Number
2602876|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|8 Weeks after PDT #1|ITT|||participants|||Number
2602877|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|4 Weeks after PDT #1|ITT|||participants|||Number
2602878|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|2 Weeks after PDT #1|ITT|||ITT|||Number
2602879|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|24-48 Hours after PDT #1|ITT|||participants|||Number
2602880|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 minutes after PDT #1|ITT|||participants|||Number
2602881|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|During PDT #1|ITT|||participants|||Number
2602882|NCT02137785|Other Pre-specified|Stinging/Burning|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline|ITT|||participants|||Number
2602883|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|12 Weeks after PDT #1|ITT|||participants|||Number
2602884|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|8 Weeks after PDT #1|ITT|||participants|||Number
2602885|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|4 Weeks after PDT #1|ITT|||participants|||Number
2602886|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|2 weeks after PDT #1|ITT|||participants|||Number
2602887|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24-48 hours after PDT #1|ITT|||participants|||Number
2602888|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 minutes after PDT #1|ITT|||participants|||Number
2602889|NCT02137785|Other Pre-specified|Edema|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline|ITT|||participants|||Number
2602890|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|12 Weeks after PDT #1|ITT|||participants|||Number
2602891|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|8 Weeks after PDT #1|ITT|||participants|||Number
2602892|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|4 Weeks after PDT #1|ITT|||participants|||Number
2602893|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|2 Weeks after PDT #1|ITT|||participants|||Number
2602894|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24-48 hours after PDT #1|ITT|||participants|||Number
2602895|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 minutes after PDT #1|ITT|||participants|||Number
2602896|NCT02137785|Other Pre-specified|Erythema|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline|ITT|||participants|||Number
2602897|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|12 Weeks after PDT #1|ITT|||participants|||Number
2602898|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|8 Weeks after PDT #1|ITT|||participants|||Number
2603892|NCT02127710|Secondary|Area Under Plasma Concentration Time Curve for AZD6094 After Single Dose|The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.|24 Hours||||h*ng/mL||Standard Deviation|Mean
2602899|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|4 Weeks after PDT #1|ITT|||participants|||Number
2602900|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|2 Weeks after PDT #1|ITT|||participants|||Number
2602901|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|24-48 hours after PDT #1|ITT|||participants|||Number
2602902|NCT02137785|Other Pre-specified|Hypopigmentation|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Baseline|ITT|||participants|||Number
2602903|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|12 Weeks after PDT #1|ITT|||participants|||Number
2602904|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|8 Weeks after PDT #1|ITT|||participants|||Number
2602905|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|4 Weeks after PDT #1|ITT|||participants|||Number
2602906|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|2 Weeks after PDT #1|ITT|||participants|||Number
2602907|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24-48 hours after PDT #1|ITT|||participants|||Number
2602908|NCT02137785|Other Pre-specified|Hyperpigmentation|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline|ITT|||participants|||Number
2602909|NCT02137785|Secondary|Subject Satisfaction Score|"Subject satisfaction score~= Excellent (very satisfied)~= Good (moderately satisfied)~= Fair (slightly satisfied)~= Poor (not satisfied at all)"|Week 12|ITT|||participants|||Number
2602910|NCT02137785|Secondary|Complete Clearance Rate|proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 8|ITT|||participants|||Number
2602911|NCT02137785|Secondary|AK Clearance Rate|{1 - [(number of AK lesions at follow-up)/(number of AK lesions at Baseline)]} x 100|Baseline and Week 8|ITT using observed data only|||percentage of baseline lesions cleared||Standard Deviation|Mean
2602912|NCT02137785|Secondary|AK Clearance Rate|{1 - [(number of AK lesions at follow-up)/(number of AK lesions at Baseline)]} x 100|Baseline and Week 12|ITT using observed data only|||percentage of baseline lesions cleared||Standard Deviation|Mean
2602913|NCT02137785|Primary|Complete Clearance Rate|proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 12|ITT|||participants|||Number
2602923|NCT02137772|Primary|Percentage of Participants With Clinically-significant CMV Infection up to Week 24 Post-transplant|Clinically-significant CMV infection was defined as either one of the following: 1) onset of CMV end-organ disease, or 2) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with clinically-significant CMV infection was assessed.|Up to Week 24 post-transplant|The Full Analysis Set (FAS) was all randomized participants who received ≥1 dose of study drug and had no detectable CMV DNA on Day 1 (randomization). Participants who prematurely discontinued or had a missing outcome through the 24-week visit window were considered treatment failure (i.e. Non-completers equal failure [NC=F] approach was used).|||Percentage of participants|||Number
2602914|NCT02137772|Other Pre-specified|Percentage of Participants Discontinued From Study Medication Due to an Adverse Event|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.|Up to Week 14 post-transplant|All randomized participants who received at least one dose of study medication|||Percentage of participants|||Number
2602915|NCT02137772|Other Pre-specified|Percentage of Participants With One or More Adverse Events up to Week 48 Post-transplant|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.|Up to Week 48 post-transplant|All randomized participants who received at least one dose of study medication|||Percentage of participants|||Number
2602916|NCT02137772|Secondary|Time to Initiation of Pre-emptive Therapy for CMV Viremia (Kaplan-Meier Estimate of Percentage of Participants With a Qualifying Event at Week 24 Post-transplant)|The need for anti-CMV pre-emptive therapy was based on documented CMV viremia and the clinical condition of the participant. The outcome was calculated from the day of transplantation to the start of anti-CMV pre-emptive therapy, and was analyzed by the Kaplan-Meier method. Participants were censored at the last assessment for participants who discontinued or did not initiate pre-emptive therapy.|Up to Week 24 post-transplant|All randomized participants who received at least one dose of study drug and had no detectable CMV viral DNA on the day treatment was initiated.|||Percentage of participants||95% Confidence Interval|Number
2602917|NCT02137772|Secondary|Percentage of Participants With Pre-emptive Therapy for CMV Viremia up to Week 24 Post-transplant|Initiation of anti-CMV pre-emptive therapy was based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with initiation of anti-CMV pre-emptive anti-CMV therapy was assessed.|Up to Week 24 post-transplant|The FAS was all randomized participants who received ≥1 dose of study drug and had no detectable CMV DNA on Day 1. Participants who prematurely discontinued or had a missing outcome through the 24-week visit window were considered treatment failure (i.e. NC=F approach was used).|||Percentage of participants|||Number
2602918|NCT02137772|Secondary|Percentage of Participants With Pre-emptive Therapy for CMV Viremia up to Week 14 Post-transplant|Initiation of anti-CMV pre-emptive therapy was based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with initiation of anti-CMV pre-emptive anti-CMV therapy was assessed.|Up to Week 14 post-transplant|The FAS was all randomized participants who received ≥1 dose of study drug and had no detectable CMV DNA on Day 1. Participants who prematurely discontinued or had a missing outcome through the 14-week visit window were considered treatment failure (i.e. NC=F approach was used).|||Percentage of participants|||Number
2602919|NCT02137772|Secondary|Percentage of Participants With CMV End-organ Disease up to Week 14 Post-transplant|CMV end-organ disease met per-protocol diagnostic criteria for CMV-pneumonia, gastrointestinal disease, hepatitis, central nervous system disease, retinitis, nephritis, cystitis, myocarditis, pancreatitis, or other disease categories. Only Clinical Adjudication Committee-confirmed CMV end-organ disease was included in this analysis. The percentage of participants with CMV end-organ disease was assessed.|Up to Week 14 post-transplant|The FAS was all randomized participants who received ≥1 dose of study drug and had no detectable CMV DNA on Day 1. A participant with a missing value up to Week 14 was excluded from the analysis (i.e., Data as observed [DAO] approach was used).|||Percentage of participants|||Number
2602920|NCT02137772|Secondary|Percentage of Participants With CMV End-organ Disease up to Week 24 Post-transplant|CMV end-organ disease met per-protocol diagnostic criteria for CMV-pneumonia, gastrointestinal disease, hepatitis, central nervous system disease, retinitis, nephritis, cystitis, myocarditis, pancreatitis, or other disease categories. Only Clinical Adjudication Committee-confirmed CMV end-organ disease was included in this analysis. The percentage of participants with CMV end-organ disease was assessed.|Up to Week 24 post-transplant|The FAS was all randomized participants who received ≥1 dose of study drug and had no detectable CMV DNA on Day 1. A participant with a missing value up to Week 24 was excluded from the analysis (i.e., Data as observed [DAO] approach was used).|||Percentage of participants|||Number
2602921|NCT02137772|Secondary|Percentage of Participants With Clinically-significant CMV Infection up to Week 14 Post-transplant|Clinically-significant CMV infection was defined as either one of the following: 1) onset of CMV end-organ disease, or 2) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant. The percentage of participants with clinically-significant CMV infection was assessed.|Up to Week 14 post-transplant|The FAS was all randomized participants who received ≥1 dose of study drug and had no detectable CMV DNA on Day 1. Participants who prematurely discontinued or had a missing outcome through the 14-week visit window were considered treatment failure (i.e. NC=F approach was used).|||Percentage of participants|||Number
2602922|NCT02137772|Secondary|Time to Onset of Clinically-significant CMV Infection (Kaplan-Meier Estimate of Percentage of Participants With a Qualifying Event at Week 24 Post-transplant)|Clinically-significant CMV infection was defined as either one of the following: 1) onset of CMV end-organ disease, or 2) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant. Time to onset of clinically-significant CMV infection was defined from the day of transplantation to the day the participant developed clinically-significant CMV infection, and was analyzed by the Kaplan-Meier method. Participants were censored at the last assessment for participants who discontinued or did not develop clinically-significant CMV infection.|Up to Week 24 post-transplant|All randomized participants who received at least one dose of study drug and had no detectable CMV viral DNA on the day treatment was initiated.|||Percentage of participants||95% Confidence Interval|Number
2602928|NCT02137512|Other Pre-specified|Episodes of Severe Hypoglycemia Events - Extension Phase|Episodes of severe hypoglycemia events during the 5-month extension phase defined as an event requiring assistance of another person due to altered consciousness to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the subject was impaired cognitively to the point that he/she was unable to treat him or herself, was unable to verbalize his or her needs, was incoherent, disoriented, and/or combative, or experienced seizure or coma. These episodes may be associated with sufficient neuroglycopenia to induce seizure or coma. If plasma glucose measurements are not available during such an event, neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.|5 months||||events|||Number
2602929|NCT02137512|Other Pre-specified|Time Spent >16.7 mmol/L (300 mg/dL) - Extension Phase|Percentage of CGM Measured Glucose Values >16.7 mmol/L (300 mg/dL) during study Extension Phase|3 months|One subject had missing CGM data at baseline and was not included in this analysis|||percentage of CGM values in range||Inter-Quartile Range|Median
2602930|NCT02137512|Other Pre-specified|Time Spent >13.9 mmol/L (250 mg/dL) - Extension Phase|Percentage of CGM Measured Glucose Values >13.9 mmol/L (250 mg/dL) during study Extension Phase|3 months|One subject had missing CGM data at baseline and was not included in this analysis|||percentage of CGM values in range||Inter-Quartile Range|Median
2602931|NCT02137512|Other Pre-specified|Time Spent >10.0 mmol/L (180 mg/dL) - Extension Phase|Percentage of CGM Measured Glucose Values >10.0 mmol/L (180 mg/dL) during study Extension Phase|3 months|One subject had missing CGM data at baseline and was not included in this analysis|||percentage of CGM values >10.0 mmol/L||Inter-Quartile Range|Median
2602932|NCT02137512|Other Pre-specified|Time in Range 3.9-10.0 mmol/L (70-180 mg/dL) - Extension Phase|Percentage of CGM Measured Glucose Values in range 3.9-10.0 mmol/L (70-180 mg/dL)|3 months|One subject had missing CGM data at baseline and was not included in this analysis|||percentage of CGM values in range||Inter-Quartile Range|Median
2602933|NCT02137512|Other Pre-specified|Time Spent <2.8 mmol/L (50 mg/dL) - Extension Phase|Percentage of CGM Measured Glucose Values <2.8 mmol/L (50 mg/dL) during study Extension Phase|3 months|One subject had missing CGM data at baseline and was not included in this analysis|||mmol/L||Inter-Quartile Range|Median
2602934|NCT02137512|Other Pre-specified|Time Spent <3.3 mmol/L (60 mg/dL) - Extension Phase|Percentage of CGM Measured Glucose Values <3.3 mmol/L (60 mg/dL) during study Extension Phase|3 months|One subject had missing CGM data at baseline and was not included in this analysis|||mmol/L||Inter-Quartile Range|Median
2602935|NCT02137512|Other Pre-specified|Time Spent <3.9 mmol/L (70 mg/dL) - Extension Phase|Percentage of CGM Measured Glucose Values <3.9 mmol/L (70 mg/dL) during study Extension Phase|3 months|One subject had missing CGM data at baseline and was not included in this analysis|||mmol/L||Inter-Quartile Range|Median
2602936|NCT02137512|Other Pre-specified|Change in HbA1c - Extension Phase|Comparison of HbA1c collected at baseline and at the end of the 5-month extension phase|5 months|One participant was excluded due to missing baseline CGM data|||percentage||Standard Deviation|Mean
2602937|NCT02137512|Other Pre-specified|Mean Sensor Glucose - Extension Phase|Mean CGM sensor glucose during Extension Phase|3 months|One subject had missing CGM data at baseline and was not included in this analysis|||mmol/L||Standard Deviation|Mean
2602938|NCT02137512|Secondary|Time Spent >300 mg/dL - Main Phase, Day Only|Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase, day only (07:00 - 23:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602939|NCT02137512|Secondary|Time Spent >300 mg/dL - Main Phase, Night Only|Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase, night only (23:00 to 07:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602940|NCT02137512|Secondary|Time Spent >300 mg/dL - Main Phase, Day and Night|Percentage of CGM Measured Glucose Values >300 mg/dl during study Main Phase|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602941|NCT02137512|Secondary|Time Spent >250 mg/dL - Main Phase, Day Only|Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase, day only (07:00 - 23:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602942|NCT02137512|Secondary|Time Spent >250 mg/dL - Main Phase, Night Only|Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase, night only (23:00 to 07:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602943|NCT02137512|Secondary|Time Spent >250 mg/dL - Main Phase, Day and Night|Percentage of CGM Measured Glucose Values >250 mg/dl during study Main Phase|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602944|NCT02137512|Secondary|AUC 180 mg/dL - Main Phase, Day Only|Area Under the Curve (AUC) 180 mg/dL - Main Phase, day only (07:00 - 23:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).|2 weeks|One participant was excluded due to missing baseline CGM data|||mg/dL||Inter-Quartile Range|Median
2602945|NCT02137512|Secondary|AUC 180 mg/dL - Main Phase, Night Only|Area Under the Curve (AUC) 180 mg/dL - Main Phase, night only (23:00 - 07:00). The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).|2 weeks|One participant was excluded due to missing baseline CGM data|||mg/dL||Inter-Quartile Range|Median
2602946|NCT02137512|Secondary|AUC 180 mg/dL - Main Phase, Day and Night|Area Under the Curve (AUC) 180 mg/dL - Main Phase, Day and Night. The hyperglycemic AUC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, the hyperglycemic AUC is 28 (mg/dl)*days for Patient A and 56 (mg/dl)*days for Patient B when using 180 as the threshold. But this is artificial because Patient B wore the sensor twice as long. So we similarly scale it relative to the number of readings to reflect a mean rather than a sum. So we say hyperglycemic AUC = 4 mg/dl for both patients. Note that time disappears from the units in the scaled version. It represents the mean value of max(glucose-180, 0).|2 weeks|One participant was excluded due to missing baseline CGM data|||mg/dL||Inter-Quartile Range|Median
2602947|NCT02137512|Secondary|ADRR - Main Phase, Day and Night|Average Daily Risk Range (ADRR) - Main Phase, Day and Night. ADRR is a metric that categorizes risk for hyper and hypoglycemic events. Low risk is scored 0-19, moderate risk is scored 20-40, and high risk is 40 and above.|2 weeks|One participant was excluded due to missing baseline CGM data|||range scores||Inter-Quartile Range|Median
2602948|NCT02137512|Secondary|HBGI - Main Phase, Day Only|High Blood Glucose Index (HBGI) - Main Phase, day only (07:00 - 23:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.|2 weeks|One participant was excluded due to missing baseline CGM data|||index scores||Inter-Quartile Range|Median
2602949|NCT02137512|Secondary|HBGI - Main Phase, Night Only|High Blood Glucose Index (HBGI) - Main Phase, night only (23:00 - 07:00). The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.|2 weeks|One participant was excluded due to missing baseline CGM data|||index scores||Inter-Quartile Range|Median
2602950|NCT02137512|Secondary|HBGI - Main Phase, Day and Night|High Blood Glucose Index (HBGI) - Main Phase, Day and Night. The HBGI metric is used to quantify the risk of hyperglycemia. A higher HBGI implies more mild hyperglycemic events or less severe hyperglycemic events.|2 weeks|One participant was excluded due to missing baseline CGM data|||index scores||Inter-Quartile Range|Median
2602951|NCT02137512|Secondary|AOC 70 mg/dL - Main Phase, Day Only|Area Over the Curve (AOC) 70 mg/dL - Main Phase, day only (07:00 - 23:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.|2 weeks|One participant was excluded due to missing baseline CGM data|||mg/dL||Inter-Quartile Range|Median
2602952|NCT02137512|Secondary|AOC 70 mg/dL - Main Phase, Night Only|Area Over the Curve (AOC) 70 mg/dL - Main Phase, night only (23:00 - 07:00). The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.|2 weeks|One participant was excluded due to missing baseline CGM data|||mg/dL||Inter-Quartile Range|Median
2602953|NCT02137512|Secondary|AOC 70 mg/dL - Main Phase, Day and Night|Area Over the Curve (AOC) 70 mg/dL - Main Phase, Day and Night. The hypoglycemia AOC is scaled to the number of CGM readings so the time factor cancels out. Technically, the units would be mg/dl, but this might seem unintuitive since it is incremental relative to a threshold. For example, a hypoglycemia AOC of 1 mg/dl can denote a glucose of 60 mg/dl for 10% of the time (10 mg/dl below threshold * 10% = 1 mg/dl) or 65 mg/dl for 20% of the time (5 mg/dl below threshold * 20% = 1 mg/dl). Note that it is based on relative (%) rather than absolute time so there is no time element in the resulting units.|2 weeks|One participant was excluded due to missing baseline CGM data|||mg/dL||Inter-Quartile Range|Median
2602954|NCT02137512|Secondary|LBGI - Main Phase, Day Only|Low Blood Glucose Index (LBGI) - Main Phase, day only (07:00 - 23:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.|2 weeks|One participant was excluded due to missing baseline CGM data|||index scores||Inter-Quartile Range|Median
2602955|NCT02137512|Secondary|LBGI - Main Phase, Night Only|Low Blood Glucose Index (LBGI) - Main Phase, night only (23:00 - 07:00). The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.|2 weeks|One participant was excluded due to missing baseline CGM data|||index scores||Inter-Quartile Range|Median
2602956|NCT02137512|Secondary|LBGI - Main Phase, Day and Night|Low Blood Glucose Index (LBGI) - Main Phase, Day and Night. The LGBI metric is used to quantify the risk of hypoglycemia. A higher LBGI implies more mild hypoglycemic events or less severe hypoglycemic events.|2 weeks|One participant was excluded due to missing baseline CGM data|||index scores||Inter-Quartile Range|Median
2602957|NCT02137512|Secondary|Time Spent <60 mg/dL - Main Phase, Day Only|Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase, day only (07:00 - 23:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602958|NCT02137512|Secondary|Time Spent <60 mg/dL - Main Phase, Night Only|Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase, night only (23:00 - 07:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602959|NCT02137512|Secondary|Time Spent <60 mg/dL - Main Phase, Day and Night|Percentage of CGM Measured Glucose Values <60 mg/dl during study Main Phase|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602960|NCT02137512|Secondary|Time Spent <50 mg/dL - Main Phase, Day Only|Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase, day only (07:00 - 23:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602961|NCT02137512|Secondary|Time Spent <50 mg/dL - Main Phase, Night Only|Percentage of CGM Measured Glucose Values <50 mg/dl during study Main Phase, night only (23:00 to 07:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602970|NCT02137512|Secondary|Glucose Coefficient of Variation - Main Phase, Night Only|CGM Glucose Coefficient of Variation (CV) during study Main Phase, night only (23:00 - 07:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage||Inter-Quartile Range|Median
2602971|NCT02137512|Secondary|Glucose Coefficient of Variation - Main Phase, Day and Night|CGM Glucose Coefficient of Variation (CV) during study Main Phase|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage||Inter-Quartile Range|Median
2602972|NCT02137512|Secondary|Mean Sensor Glucose - Main Phase, Day Only|Mean CGM sensor glucose during study Main Phase, day only (07:00 - 23:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||mg/dL||Standard Deviation|Mean
2602973|NCT02137512|Secondary|Mean Sensor Glucose - Main Phase, Night Only|Mean CGM sensor glucose during study Main Phase, night only (23:00 - 07:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||mg/dL||Standard Deviation|Mean
2602974|NCT02137512|Secondary|Mean Sensor Glucose - Main Phase, Day and Night|Mean CGM sensor glucose during study Main Phase|2 weeks|One participant was excluded due to missing baseline CGM data|||mg/dL||Standard Deviation|Mean
2602975|NCT02137512|Secondary|Time in Range 70-180 mg/dL - Main Phase, Day Only|Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, day only (07:00 - 23:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602976|NCT02137512|Secondary|Time in Range 70-180 mg/dL - Main Phase, Night Only|Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase, night only (23:00 - 07:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602977|NCT02137512|Secondary|Time in Range 70-180 mg/dL - Main Phase, Day and Night|Percentage of CGM Measured Glucose Values in range 70-180 mg/dl during study Main Phase|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602978|NCT02137512|Secondary|Time Spent <70 mg/dL - Main Phase, Day Only|Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase, day only (07:00 - 23:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602979|NCT02137512|Secondary|Time Spent <70 mg/dL - Main Phase, Day and Night|Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602980|NCT02137512|Primary|Time Spent <70 mg/dL - Main Phase, Night Only|Percentage of CGM Measured Glucose Values <70 mg/dl during study Main Phase, night only (23:00 to 07:00)|2 weeks|One participant was excluded due to missing baseline CGM data|||percentage of CGM values||Inter-Quartile Range|Median
2602981|NCT02137499|Secondary|Leg Volume|"Measured using ankle and calf circumference, and multiplying using inverted cone method"|6 weeks|Data not collected||||||
2602982|NCT02137499|Secondary|Improvement in Venous Symptoms|Clinical symptoms will be measured using questionnaires (AVVQ, VCSS)|6 weeks|Data not collected||||||
2602983|NCT02137499|Primary|Percentage Change of Haemodynamic Flow|Doppler ultrasound measurements of femoral venous blood flow. The volume flow rate in blood vessel can be calculated by multiplying the cross-sectional area of the blood vessel by the mean velocity of the blood within it.|baseline, 20 minutes||||% change||Inter-Quartile Range|Median
2602984|NCT02137486|Secondary|Procedure Time(Minutes) of Each Participants|as medical chart record.|periprocedure up to 12 months.|procedure time(minutes) of each participants|||minutes||Standard Deviation|Mean
2602985|NCT02137486|Secondary|Fluoroscopy Time(Minutes) of Each Participants|as medical chart record.|periprocedure up to 12 months.|fluoroscopy time(minutes) of each participants|||minutes||Standard Deviation|Mean
2602986|NCT02137486|Secondary|Percentage of Participants With Target Vessel Revascularization Rate|Percentage of Participants with target vessel revascularization rate, both arms|periprocedure up to 12 months.|Percentage of Participants with target vessel revascularization rate, both arms|||Participants|||Count of Participants
2602987|NCT02137486|Secondary|Percentage of Participants With Angiographic Success(%)|Percentage of Participants with angiographic success was defined as residual stenosis<50% under fluoroscopy at the end of procedure.|periprocedure up to 12 months.|lesions of participants; 100%x90/112; 100%x84/102.|||Participants|||Count of Participants
2602988|NCT02137486|Primary|Percentage of Participants With Cardiovascular Mortality(%)|Percentage of Participants with cardiovascular mortality was defined as death related to cardiovascular causes within 2 years.|periprocedure up to 12 months|100%x0/112; 100%x1/102|||Participants|||Count of Participants
2602989|NCT02137486|Primary|Percentage of Participants With Major Adverse Cardiac Events(MACE)|Percentage of Participants with major adverse cardiac events(MACE) was defined as rates of target lesion revascularization (TLR) and restenosis during first post-treatment year, and rates of acute, subacute, and late in-stent thrombosis, periprocedure MI(myocardial infarction).|periprocedure up to 12 months|100%x2/112; 100%x7/102|||percentage of participants||95% Confidence Interval|Number
2602990|NCT02137447|Secondary|Composite Secondary Outcomes of Non-infectious Abdominal Wound Complications, Damage to the Skin Caused by the Dressing, Need to End the Treatment Prior to Discharge or Prior to 5-7 Post-operative Days, and Need for Reapplication of the System.|"Secondary (composite) outcomes:~other non infectious abdominal wound complications,~damage to the skin caused by the dressing~need to end the treatment prior the discharge OR prior to 5 -7 post- operative days.~need for re-application of the system for any reason"|4 weeks||||Participants|||Count of Participants
2602991|NCT02137447|Primary|Number of Participants With Surgical Site Infections Within 1 Month (4 Weeks ) From Index Operation|Incidence of SSIs within 1 month (4 weeks) from the index operation. SSI is defined by the Centers for Disease Control and Prevention's National Healthcare Surveillance Network|30 days||||Participants|||Count of Participants
2602992|NCT02137382|Secondary|Percentage of Days With Formed/Normal Stools|The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/ number of days recorded in diary).|5 days|Per protocol|||percentage of days||Standard Deviation|Mean
2602993|NCT02137382|Secondary|Percentage of Days With no Abdominal Pain|The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100*(number of days with no abdominal pain/ number of days recorded in diary).|5 days|Per protocol|||percentage of days||Standard Deviation|Mean
2602994|NCT02137382|Secondary|Percentage of Days With no Flatulence|The percentage of days with no flatulence is calculated from the diary during the treatment period: 100*(number of days with no flatulence/number of days recorded in diary).|5 days|Per protocol|||percentage of days||Standard Deviation|Mean
2602995|NCT02137382|Secondary|Stool Frequency|Stool frequency is the average of the daily number of stools recorded during the treatment period|5 days|Per protocol|||number of stools per day||Standard Deviation|Mean
2602996|NCT02137382|Secondary|Total Fat Excretion|Total amount of fat excreted during the stool collection period in grams.|5 days|Per protocol|||Grams||Standard Deviation|Mean
2602997|NCT02137382|Secondary|Coefficient of Nitrogen Absorption (CNA).|CNA is calculated from nitrogen intake and nitrogen excretion, according to the formula: CNA (%) = 100 [nitrogen intake - nitrogen excretion] / nitrogen intake)|5 days|Per protocol|||percentage of nitrogen intake||Standard Deviation|Mean
2602998|NCT02137382|Primary|Coefficient of Fat Absorption (CFA)|CFA is calculated from fat intake and fat excretion, according to the formula: CFA (%) = 100 [fat intake - fat excretion] / fat intake|5 days|Per protocol|||percentage of fat intake||Standard Deviation|Mean
2602999|NCT02137226|Primary|The Proportion of Patients Meeting ACR20 Response Criteria at Week 24|ACR20 at Week 12 and Week 24 are standard outcome criteria that are widely accepted for regulatory purposes to demonstrate efficacy in treating the signs and symptoms of Rheumatoid arthritis (RA). The proportion of patients meeting the ACR20 response criteria was assessed at Week 12 and Week 24 to provide a robust comparison with US-licensed Humira® data. A patient had an ACR20 response if all of the following occurred: A ≥ 20 % improvement in the swollen joint count (66 joints), A ≥ 20 % improvement in the tender joint count (68 joints), A ≥ 20 % improvement in at least three of the following assessments: Patient's assessment of pain, Patient's global assessment of disease activity (equivalent to the General Health component of the Disease Activity Score ([DAS]), Physician's global assessment of disease activity, Patient's assessment of physical function, as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) Acute phase reactant (C-reactive protein [CRP]).|Week 24|Full Analysis Set. Patients who discontinued treatment prior to the time-point had their binary response imputed as non-responder, a method commonly known as non-responder imputation. For truly missing data at the component level, multiple imputation was used.|||Percentage of Patients|||Number
2603000|NCT02137226|Secondary|The Percentage of Patients With Investigator-assessed Drug-related Adverse Events (AEs) During the Treatment Phase|"The analysis of AEs was based on the concept of treatment-emergent AEs (TEAEs). Thus, all AEs with an onset after the first dose of trial drug up to a period of ten weeks after the last dose of trial drug were assigned to the current treatment for evaluation. Investigator-assessed drug related AEs were AEs with a relationship to drug ticked yes according to the Investigator. Overall results are presented from Day 1 up to Week 58 and are based on the initial randomization groups. The comparison therefore focuses on patients who received BI 695501 continuously versus patients who received Humira® continuously for the long term assessment of safety. One patient was initially treated with Humira and discontinued prior to Week 24. This patient was mistakenly re randomized to BI 695501 but not treated. For safety this was counted in Humira not re-randomized group (as treated), and for other analysis sets, this patient was counted in the Humira to BI 695501 group (as randomized)."|From the first drug administration until 10 weeks after the last drug administration, up to 58 weeks|The Safety Analysis Set contained all patients who received at least one dose of trial drug.|||Percentage of Patients|||Number
2603001|NCT02137226|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28) (Erythrocyte Sedimentation Rate [ESR]) at Week 12 and Week 24|"The DAS28 (ESR) score was derived using the following formulae:~DAS28 (ESR) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.014*(GH) + 0.7*ln(ESR)~Where:~TJC28 = 28 joint count for tenderness~SJC28 = 28 joint count for swelling~Ln (ESR) = natural logarithm of ESR~GH = General Health component of the DAS (patient's global assessment of disease activity). DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. Actual number of patient analysed (N) is mean number of subjects in the analysis set with DAS28(ESR) results computable across the multiply imputed data sets. It is 319.6, 317.1 for week 12 and 313.9, 315.1 for week 24 for BI 695501 and US-licensed Humira® respectively."|Baseline, Week 12 and Week 24|Full Analysis Set. Patients who discontinued treatment prior to the time-point had their binary response imputed as non-responder, a method commonly known as non-responder imputation. For truly missing data at the component level, multiple imputation was used.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2603002|NCT02137226|Primary|The Proportion of Patients Meeting the American College of Rheumatology 20% (ACR20) Response Criteria at Week 12|The proportion of patients meeting the ACR20 response criteria was assessed. A patient had an ACR20 response if all of the following occurred: A ≥ 20 % improvement in the swollen joint count (66 joints), A ≥ 20 % improvement in the tender joint count (68 joints), A ≥ 20 % improvement in at least three of the following assessments: Patient's assessment of pain, Patient's global assessment of disease activity (equivalent to the General Health component of the Disease Activity Score (DAS)), Physician's global assessment of disease activity, Patient's assessment of physical function, as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI) Acute phase reactant (C-reactive protein (CRP)).The Full Analysis Set contained all enrolled patients who were randomized to trial drug and who received at least one dose of trial drug and had all efficacy measures relevant for the co-primary efficacy endpoints measured at baseline and at least once post- baseline.|Week 12|Full Analysis Set. Patients who discontinued treatment prior to the time-point had their binary response imputed as non-responder, a method commonly known as non-responder imputation. For truly missing data at the component level, multiple imputation was used.|||Percentage of Patients|||Number
2603003|NCT02137096|Primary|Evaluate the Tumor Response|To evaluate the response rates for patients undergoing high dose conditioning using Etoposide, Carboplatin and Ifosfamide followed by autologous stem cell transplantation for the treatment of recurrent NPC in children, adolescents, and young adults.|12 months after completion of treatment|Due to only one subject being enrolled data analysis was completed||||||
2603004|NCT02136914|Secondary|Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms|The CGI-C consisted of a single question that assessed the investigator's global impression of the subject's change from Baseline in overall PD symptoms, including but not limited to LID. The CGI-C required that the investigator rate the extent to which the subject's PD had improved or worsened (from marked worsening to marked improvement). The CGI-C was assessed at Baseline and Weeks 2, 8, 12, 18, and 24.|Baseline to Week 12 and Week 24|MITT population|||Participants|||Count of Participants
2603005|NCT02136914|Secondary|Change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Score (Parts I, II, and III)|The MDS-UPDRS Parts I, II, and III examined non-motor experiences of daily living, motor experiences of daily living, and motor examination, respectively. Each Part contains items or questions that were each rated on a scale from 0 (normal) to 4 (severe). The Combined Parts I, II, and III (representing the sum of the individual scores from Parts I, II, and III) has a scale range of 0-236. Higher scores, whether for individual Parts or the sum of the combined Parts, indicate more severe PD.|Baseline (BL) to Week 12 (W12) and Week 24 (W24)|MITT population|||units on a scale||Standard Error|Least Squares Mean
2603006|NCT02136914|Secondary|Change in the Standardized PD Home Diary (ON Time Without Troublesome Dyskinesia, ON Time With Troublesome Dyskinesia, OFF Time)|A PD home diary was used to score 5 different conditions in 30-minute intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. The results were based on 2 consecutive 24-hour diaries taken prior to the day of randomization and prior to the Week 2, 8, 12, 18, and 24 visits.|Baseline (BL) to Week 12 (W12) and Week 24 (W24)|MITT population|||hours||Standard Error|Least Squares Mean
2603007|NCT02136914|Secondary|Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 24|The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 8, 12, 18, and 24.|Baseline to Week 24|MITT population|||units on a scale||Standard Error|Least Squares Mean
2603008|NCT02136914|Primary|Change From Baseline in the Unified Dyskinesia Rating Scale (UDysRS) Score at Week 12|The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 8, 12, 18, and 24.|Baseline to Week 12|MITT population|||units on a scale||Standard Error|Least Squares Mean
2603009|NCT02136810|Secondary|Preidentified Subgroup Analysis|The investigators will examine the correlation between blood pressure and heart rate in the subset of patients without hypertension diagnosis.|1 year|||||||
2603010|NCT02136810|Secondary|Patient Adherence|The possible association of medication adherence (Morisky scale) with home blood pressure monitor-status will be examined by the Mantel-Haenszel Chi-Square Test.|60 days|||||||
2603011|NCT02136810|Secondary|Patient Perspectives|The possible association of self-reported availability of primary care (5 point LIKERT scale) with home blood pressure monitor-status will be examined by the Mantel-Haenszel Chi-Square Test.|60 days|||||||
2603012|NCT02136810|Secondary|Preidentified Subgroups|The investigators will examine the correlation between blood pressure and heart rate in the subset of patients with hypertension diagnosis.|1 year|||||||
2603013|NCT02136810|Secondary|Patient Perspectives and Beliefs Regarding Blood Pressure Status as They Relate to Actual Home Blood Pressures.|In secondary analyses, the agreement between patients' self-reported blood pressure control (binary outcome) and home blood pressure monitor-determined blood pressure status (binary outcome) will we assessed via Cohen's kappa and raw indices of agreement.|Approximately 60 days|||||||
2603014|NCT02136810|Primary|Performance of Blood Pressure Referral Threshold|The positive predictive value of preadmission testing-measured blood pressure to predict mean home blood pressure >135/85mmHg will be calculated.|Subjects followed for approximately 1 year|Of the 200 participants, 188 returned Home BP Cuffs with valid BP data.|||ppv for home bp elevation||95% Confidence Interval|Number
2603015|NCT02136680|Secondary|Adherence|Self-reported adherence over the past month by an item from the Adult Aids Clinical Trials Group (AACTG) questionnaire.|Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1|Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1. There was 1 case for which adherence data was missing for the patient.|||Participants|||Count of Participants
2603016|NCT02136680|Secondary|Viral Load Suppressed|Patient is HIV viral load suppressed, as abstracted from patient electronic medical records.|Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1|Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1. There were 11 cases for which viral load information was missing from the patient medical records.|||Participants|||Count of Participants
2603017|NCT02136680|Primary|Health-Related Quality of Life in Palliative Care: Palliative Outcome Scale|The Palliative Outcome Scale (POS) is a 10-item multidimensional well-being tool well validated for use in palliative care settings that measures the 3-day period prevalence and intensity of pain, other physical symptoms, patient anxiety, family/friends anxiety, information sufficiency, sharing feelings with family/friends, feeling life is worthwhile, self-worth, wasted time, and personal affairs, i.e. the physical/social/spiritual/psychological problems in line with the World Health Organization (WHO) definition of palliative care. Eight of the 10 items use a five-point Likert-like scale, and the remaining two items use a three-point scale. Scores for respondents' ratings on all items can range from 0 (indicating no problem) to 4 (indicating a very severe or overwhelming problem). The overall profile score is the sum of the scores from each of the 10 questions and can therefore range from zero to 40. Higher scores are indicative of greater problems.|Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1|Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1|||[Units on a scale]||Standard Deviation|Mean
2603018|NCT02136680|Primary|Quality of Life: McGill Quality of Life Scale|The McGill Quality of Life Questionnaire (MQOL) is a measure of quality of life for persons with advanced/serious illness. The MQOL consists of 16-items plus a global quality of life item, each with a 2-day time frame and has demonstrated validity and other measurement properties for use with palliative care populations. There are four subscales (psychological symptoms, existential well-being, support, and physical symptoms) and a summary quality of life score that weights these domains equally. Items are scored zero (worst) to 10 (excellent).|Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1|Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1|||[Units on a scale]||Standard Deviation|Mean
2603472|NCT02131532|Secondary|SIS - Physical Strength|The physical strength subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
2603019|NCT02136680|Primary|Mental Health: Rosenberg Self-Esteem Scale|Rosenberg Self-Esteem Scale: The Rosenberg Self-Esteem Scale (RSES) is a 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. The scale is well validated and has been used in a wide variety of populations, including persons living with HIV/AIDS. All items are answered using a 4-point Likert scale format ranging from strongly agree to strongly disagree. Scores for individual items varied in range from 1 to 4, with higher scores indicative of greater self-esteem. Summary score is reflective of the mean score across all items.|Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1|Baseline, 1st Follow-up [FU1]: 4-5 mos post-initiation of baseline/intervention, 2nd Follow-up [FU2]: 4-5 mos post FU1|||[Units on a scale]||Standard Deviation|Mean
2603020|NCT02136498|Secondary|Number of Days of Varenicline Use|Number of days varenicline was used|5 mo follow-up||||Mean number of days||Standard Deviation|Mean
2603021|NCT02136498|Primary|Point Prevalence Abstinence|Self-report of no-smoking, even a puff during the last 7 days.|5 month follow-up|Intent to treat analyses with missing cases imputed as smokers.|||Percentage of people not smoking|||Number
2603022|NCT02136420|Primary|Percent Change in Manual Control Performance After Exposure to Hypogravity|"Note that this applies to arms 6-9 only.~Subjects sat on a chair on a moving platform on top of a centrifuge that created an artificial gravity environment. Subjects completed a manual control task in which their charge was randomly perturbed in roll tilt, and they used a joystick to attempt to keep themselves aligned with upright, while in the dark. They did this while experiencing centripetal acceleration equivalent to Earth gravity (1 Gz), and then hypogravity (0.5 Gz). We calculated their performance by calculating the standard deviation of chair position across time, with a smaller number indicating better performance. Then we calculated the percent change in their performance between 1 Gz and 0.5 Gz."|1 session||||percentage change||Standard Deviation|Mean
2603023|NCT02136420|Primary|Interaural Perceptual Motion Threshold|"This is a perceptual self-motion threshold that measures the precision of the vestibular system. It is analogous to an audiogram, but for motion. Subjects sat on a motorized platform which repeatedly provided them with small motions to the left or right. After each motion subjects report whether they perceived a motion to the left or right. Based on subject responses, a psychometric curve fit is performed that determines the threshold (the standard deviation of the underlying cumulative Gaussian). Interaural translation refers to translations in the horizontal plane to the subject's left or right.~This outcome measure applies only to arm 5 subjects."|2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication||||cm per sec||Standard Deviation|Geometric Mean
2603024|NCT02136420|Primary|Roll Perceptual Motion Threshold|"This is a perceptual self-motion threshold that measures the precision of the vestibular system. It is analogous to an audiogram, but for motion. Subjects sat on a motorized platform which repeatedly provided them with small motions to the left or right. After each motion subjects report whether they perceived a motion to the left or right. Based on subject responses, a psychometric curve fit is performed that determines the threshold (the standard deviation of the underlying cumulative Gaussian). Roll tilt means rotations about an axis that is Earth-horizontal.~This outcome measure applies only to arm 5 subjects."|2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication||||deg per sec||Standard Deviation|Geometric Mean
2603025|NCT02136420|Primary|Yaw Perceptual Motion Threshold|"This is a perceptual self-motion threshold that measures the precision of the vestibular system. It is analogous to an audiogram, but for motion. Subjects sat on a motorized platform which repeatedly provided them with small motions to the left or right. After each motion subjects report whether they perceived a motion to the left or right. Based on subject responses, a psychometric curve fit is performed that determines the threshold (the standard deviation of the underlying cumulative Gaussian). Yaw rotation means rotations about an axis that is perpendicular to gravity.~This outcome measure applies only to arm 5 subjects."|2 sessions separated by at least four days; measurements made 2 hrs after ingestion of medication||||deg per sec||Standard Deviation|Geometric Mean
2603026|NCT02136420|Primary|Percent Change in Roll Tilt Perception After Exposure to Hypogravity|"Note that this applies to arms 1-4 only.~Subjects sat on a chair on a moving platform on top of a centrifuge that created an artificial gravity environment. Subjects were repeatedly roll tilted to angles between 11 and 19 degrees, and then reported their perceived tilt angle using a subjective visual vertical task. They did this while experiencing centripetal acceleration equivalent to Earth gravity (1 Gz), and then hypogravity (0.5 Gz). We hypothesized that, after entering hypogravity, subjects would tend to underestimate their tilt angle. We calculated the percent change in their perception of tilt between 1 Gz and 0.5 Gz."|1 session||||percentage change||Full Range|Mean
2603027|NCT02136238|Primary|Physical Function Performance 10 Test Score|Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.|Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.||||units on a scale||Standard Deviation|Mean
2603028|NCT02136238|Primary|Sternal Displacement During Towel Folding Task|Distance sternum is displaced while folding a towel was measured in meters.|Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.||||meters||Standard Deviation|Mean
2603029|NCT02136134|Secondary|Overall Survival (OS)|Overall Survival was measured from the date of randomization to the date of the participant's death.|Up to the end of the study (approximately of 3 years)|The intent-to-treat (ITT) population included all randomized participants.|||months||95% Confidence Interval|Median
2603039|NCT02136004|Secondary|Time to Discharge Eligibility|Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject's access site is assessed to be hemodynamically stable, as determined by the investigator or his/her designee(s)|prior to hospital discharge, usually within 24 hours|All subjects enrolled|||hours||95% Confidence Interval|Mean
2603042|NCT02136004|Primary|Time to Hemostasis|Primary effectiveness endpoint - elapsed time between the Closer VSS delivery system removal and first observed and confirmed arterial hemostasis|procedural, usually within 15 minutes of enrollment|All subjects enrolled|||minutes||95% Confidence Interval|Mean
2603030|NCT02136134|Secondary|Percentage of Participants With Negative Minimal Residual Disease (MRD)|The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR). IMWG criteria for CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR plus normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.|Up to disease progression (approximately of 3 years)|The intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
2603031|NCT02136134|Secondary|Overall Response Rate (ORR)|The Overall response rate was defined as the percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) criteria, during the study or during follow up. IMWG criteria for PR: >=50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|Up to disease progression (approximately of 3 years)|The response-evaluable analysis set is defined as participants who have confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 administration of study treatment and had at least 1 post baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2603032|NCT02136134|Secondary|Percentage of Participants With a Very Good Partial Response (VGPR) or Better|Response rate of VGPR or better was defined as the percentage of participants who achieved VGPR and CR (including sCR) according to the IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.|Up to disease progression (approximately of 3 years)|The response evaluable analysis set is defined as participants who have a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit, received at least 1 administration of study treatment, and had at least 1 post baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2603033|NCT02136134|Secondary|Time to Disease Progression (TTP)|TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5 g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be >10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to Plasma Cell (PC) proliferative disorder.|From the date of randomization to the date of first documented evidence of progression or death due to PD whichever occurs first (approximately 3 years)|The intent-to-treat (ITT) population included all randomized participants.|||months||95% Confidence Interval|Median
2603034|NCT02136134|Primary|Progression-free Survival (PFS)|PFS was defined as duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD was defined as meeting any one of following criteria: Increase of greater than equal to (>=)25 percent (%) in level of serum M-protein from lowest response value and absolute increase must be >=0.5 gram per deciliter (g/dL); Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.|From the date of randomization to either progressive disease or death, whichever occurs first (approximately 3 years)|The intent-to-treat (ITT) population included all randomized participants.|||months||95% Confidence Interval|Median
2603035|NCT02136004|Secondary|Procedure Success|Secondary efficacy endpoint - attainment of final arterial hemostasis using any method and freedom from major access site closure-related complications through 30 days|through 30 days +/- 7 days|All subjects enrolled.|||Participants|||Count of Participants
2603036|NCT02136004|Secondary|Rate of Combined Minor Access Site Closure-related Complications|Secondary safety endpoint - rate of combined minor access site closure-related complications|through 30 +/- 7 days|All subjects enrolled|||complications|||Number
2603037|NCT02136004|Secondary|Device Success|Secondary efficacy endpoint - the ability to deploy the system, deliver the implant, and achieve arterial hemostasis with the Closer VSS alone or with post-hemostasis adjunctive compression|procedural, usually within 15 minutes of enrollment|All subjects enrolled|||Participants|||Count of Participants
2603038|NCT02136004|Secondary|Time to Hospital Discharge|Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject is actually physically discharged from the hospital ward|through hospital discharge, usually within 24 hours|All subjects enrolled|||hours||95% Confidence Interval|Mean
2603040|NCT02136004|Secondary|Time to Ambulation|Secondary efficacy endpoint - elapsed time between the Closer VSS delivery system removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site|prior to hospital discharge, usually within 24 hours|All subjects enrolled|||hours||95% Confidence Interval|Mean
2603043|NCT02135900|Primary|Mean Oxygen Saturation (M SO2)|Assessment of M SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Baseline and in 6-8 hours.|Subjects with documented sleep apnea syndrome on nocturnal polysomnography|||Percentage of oxygen saturation||95% Confidence Interval|Mean
2603044|NCT02135900|Primary|Lowest Oxygen Saturation (L SO2)|Assessment of L SO2 at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Baseline and in 6-8 hours.|Subjects with documented sleep apnea syndrome on nocturnal polysomnography|||Percentage of oxygen saturation||95% Confidence Interval|Mean
2603045|NCT02135900|Primary|Apnea Index (AI)|Assessment of Apnea Index (AI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Baseline and in 6-8 hours. The reported data are at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Subjects with documented sleep apnea syndrome on nocturnal polysomnography|||Number of apneas per hour sleep||95% Confidence Interval|Mean
2603046|NCT02135900|Primary|Apnea Hypopnea Index|Assessment of Apnea/Hypopnea Index (AHI) at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Baseline and in 6-8 hours. The reported data are at baseline ( without heliox) and after 6-8 hours of sleep with heliox.|Subjects with documented sleep apnea syndrome on nocturnal polysomnography|||Apneas or hypopneas per hour sleep||95% Confidence Interval|Mean
2603047|NCT02135861|Secondary|Assessment of Intra-subject Variability in Ktrans Between Session 1 and Session 2 of DCE-MRI|Coefficient of variation (percentage) of intra-subject variability in Ktrans between Session 1 and Session 2 for total lung has been presented.|Day 1 (Session 1) and Day 9 (Session 2)|The Evaluable Population|||Percentage|||Number
2603048|NCT02135861|Secondary|Assessment of Intra-subject Variability in Ve Between Session 1 and Session 2 of DCE-MRI|Coefficient of variation (percentage) of intra-subject variability in Ve between Session 1 and Session 2 for total lung has been presented.|Day 1 (Session 1) and Day 9 (Session 2)|The Evaluable Population|||Percentage|||Number
2603049|NCT02135861|Primary|Change in Exchange Rate (Ktrans) in ADHF Participants|Exchange rate (Ktrans) was measured by DCE-MRI. Three participants underwent 3 DCE-MRI scans. The data has been presented for individual participant in each session. The data presented below is only for total lung.|Up to Week 8|The Safety Population|||Liter/minute|||Number
2603050|NCT02135861|Primary|Change in Interstitial Volume (ve) in ADHF Participants|Interstitial volume (ve) was measured by DCE-MRI. Three participants underwent 3 DCE-MRI scans. The data has been presented for individual participant in each session. The data presented below is only for total lung.|Up to Week 8|The safety population will include all enrolled participants who have initiated at least one session of DCE-MRI or Lung Ultrasound Scan|||Liter|||Number
2603051|NCT02135861|Primary|Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise|Exchange rate (Ktrans) was measured by DCE-MRI. Ktrans for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal before and following exercise has been presented.|Day 11|The Evaluable Population|||Liter/minute||Standard Error|Least Squares Mean
2603052|NCT02135861|Primary|Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers Before and Following Exercise|Interstitial volume (ve) was measured by DCE-MRI. ve for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal before and following exercise has been presented.|Day 11|The Evaluable Population|||Liter||Standard Error|Least Squares Mean
2603053|NCT02135861|Primary|Exchange Rate (Ktrans) in Heart Failure Participants and Healthy Volunteers at Baseline|Exchange rate (Ktrans) was measured by DCE-MRI. Ktrans for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal has been presented. Session 1 values were considered as Baseline values.|Day 1|The Evaluable Population|||Liter/minute||Standard Error|Least Squares Mean
2603054|NCT02135861|Primary|Interstitial Volume (ve) in Heart Failure Participants and Healthy Volunteers at Baseline|Interstitial volume (ve) was measured by DCE-MRI. ve for total lung, left lung, right lung, left lung apical, left lung basal, right lung apical, right lung basal has been presented. Session 1 values were considered as Baseline values.|Day 1|The Evaluable Population will include participants in safety population who are 40 years and older .The safety Population includes all enrolled participants who have initiated Session 1 DCE-MRI scan|||Liter||Standard Error|Least Squares Mean
2603055|NCT02135848|Secondary|Relationship of Pharmacokinetic Parameters to the Pharmacodynamic Assessments Performed in This Study|A formal pharmacokinetic /pharmacodynamic analysis and pharmacokinetic /pharmacodynamic modelling for exposure relationships to endpoints was planned. The data for this outcome was not collected.|Visit 2 (Day 1): pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3 (Day 2)-post acute, Visit 4 (Day 16)-rescreen, Visit 5 (Day 23)-Baseline chronic and end of treatment (14 days after Visit 5) or early termination (between Visit 2 and 6)|The data for this outcome measure was not collected.||||||
2603056|NCT02135848|Secondary|Derived Plasma GSK1278863 Pharmacokinetic Parameter - Time to Maximum Plasma Concentration (T-max) and Last Time Point Where the Concentration is Above the Limit of Quantification (T-last)|Blood samples for pharmacokinetic analysis of GSK1278863 and selected metabolites were collected at the following time points: Visit 2-Baseline acute: pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3-post acute, Visit 4-rescreen, Visit 5-Baseline chronic and end of treatment or early termination. The actual date and time of each blood sample collection was recorded.|Visit 2 (Day 1): pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3 (Day 2)-post acute, Visit 4 (Day 16)-rescreen, Visit 5 (Day 23)-Baseline chronic and end of treatment (14 days after Visit 5) or early termination (between Visit 2 and 6)|Pharmacokinetic concentration population. Only those participants available at the specified time points were analyzed.|||Hour||Full Range|Median
2603057|NCT02135848|Secondary|Derived Plasma GSK1278863 Pharmacokinetic Parameter -Area Under the Curve (AUC [0-t])|Blood samples for pharmacokinetic analysis of GSK1278863 and selected metabolites were collected at the following time points: Visit 2-Baseline acute: pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3-post acute, Visit 4-rescreen, Visit 5-Baseline chronic and end of treatment or early termination. The actual date and time of each blood sample collection was recorded.|Visit 2 (Day 1): pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3 (Day 2)-post acute, Visit 4 (Day 16)-rescreen, Visit 5 (Day 23)-Baseline chronic and end of treatment (14 days after Visit 5) or early termination (between Visit 2 and 6)|Pharmacokinetic concentration Population. Only those participants available at the specified time points were analyzed.|||Nanogram x hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2603058|NCT02135848|Secondary|Derived Plasma GSK1278863 Pharmacokinetic Parameter- Maximum Plasma Concentration (Cmax) and Trough Concentration (Ctau)|Blood samples for pharmacokinetic analysis of GSK1278863 and selected metabolites were collected at the following time points: Visit 2-Baseline acute: pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3-post acute, Visit 4-rescreen, Visit 5-Baseline chronic and end of treatment or early termination. The actual date and time of each blood sample collection was recorded.|Visit 2 (Day 1): pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3 (Day 2)-post acute, Visit 4 (Day 16)-rescreen, Visit 5 (Day 23)-Baseline chronic and end of treatment (14 days after Visit 5) or early termination (between Visit 2 and 6)|Pharmacokinetic concentration population comprised of all participants from whom a pharmacokinetic sample had been obtained and analyzed. Only those participants available at the specified time points were analyzed.|||Nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2603059|NCT02135848|Secondary|Change From Baseline in Lipids (Total Cholesterol [TC], Triglycerides [TG], High Density Lipoprotein Cholesterol [HDLc] and Low Density Lipoprotein Cholesterol [LDLc])|Blood samples for analysis of fasting levels of lipid panel (TC, TG, HDLc and LDLc) was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.|||Millimoles/Liter (MMOL/L)||Standard Deviation|Mean
2603060|NCT02135848|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)|Blood samples for analysis of fasting levels of hsCRP, was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.|||Milligrams/Liter (mg/L)||Standard Deviation|Mean
2603061|NCT02135848|Secondary|Change From Baseline in Hematocrit|Blood samples for analysis of fasting levels of hematocrit was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.|||Fraction||Standard Deviation|Mean
2603062|NCT02135848|Secondary|Change From Baseline in Hemoglobin|Blood samples for analysis of fasting levels of hemoglobin was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.|||Grams per Liter||Standard Deviation|Mean
2603063|NCT02135848|Secondary|Change From Baseline in Erythropoietin Concentration|Blood samples for analysis of fasting levels of erythropoietin, was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Units per Liter||Standard Deviation|Mean
2603064|NCT02135848|Secondary|Change From Baseline in the Maximal Distance Covered During a Six-Minute Walk Test|The Six-Minute Walk Test was performed by the participant walking at a self-selected pace for 6 minutes through a pre-defined walking course. When the Six-Minute Walk Test and Bilateral Heel Raise Test were conducted at the same study visit, the participant was allowed to rest a minimum of one hour between these tests. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic Population. Only those participants available at the specified time points were analyzed.|||Feet||Standard Deviation|Mean
2603065|NCT02135848|Secondary|Change From Baseline in Total Exercise Time to Claudication-limited Maximal Muscle Performance|BHRT is a method to assess muscle performance in participants with claudication. Participants with PAD and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to the BHRT. Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg (the leg that met the inclusion symptomatic and hemodynamic criteria [ABI ≤ 0.90] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.|||seconds||Standard Deviation|Mean
2603066|NCT02135848|Secondary|Change From Baseline in Total Work Performed to Claudication-limited Maximal Muscle Performance|BHRT is a method to assess muscle performance in participants with claudication. Participants with PAD and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to the BHRT. Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg (the leg that met the inclusion symptomatic and hemodynamic criteria [ABI ≤ 0.90] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.|||kilogram-meters||Standard Deviation|Mean
2603091|NCT02135614|Secondary|Number of Hospitalization-Free Days Following Presatovir Administration||Up to Day 28|Evaluable Analysis Set: all randomized participants who received at least 1 dose of study medication, had an RSV viral load greater than lower limit of quantification (LLOQ) of the RT-qPCR assay in the Day 1 nasal-swab sample, and had a minimum of 3 quantifiable samples (including baseline) within a 5 day period.|||days||Inter-Quartile Range|Median
2623138|NCT01932970|Secondary|Percentage of Participants With Serum Corrected Calcium < 8.3 mg/dL During the 4-week Treatment Period||4 weeks|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2603067|NCT02135848|Secondary|Change From Baseline in Total Number of Contractions to Claudication-limited Maximal Muscle Performance|BHRT is a method to assess muscle performance in participants with claudication. Participants with PAD and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to the BHRT. Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg (the leg that met the inclusion symptomatic and hemodynamic criteria [ABI ≤ 0.90] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.|||Contractions||Standard Deviation|Mean
2603068|NCT02135848|Secondary|Change From Baseline in Total Exercise Time to Onset of Claudication|BHRT is a method to assess muscle performance in participants with claudication. Participants with PAD and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to the BHRT. Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg (the leg that met the inclusion symptomatic and hemodynamic criteria [ABI ≤ 0.90] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.|||Seconds||Standard Deviation|Mean
2603069|NCT02135848|Secondary|Change From Baseline in Total Work Performed to Onset of Claudication|BHRT is a method to assess muscle performance in participants with claudication. Participants with peripheral artery disease (PAD) and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to BHRT. Test familiarization consisted of the participant performing heel raises to onset of claudication. BHRT was conducted with an electrogoniometer instrumented on the index leg (leg that met the inclusion symptomatic and hemodynamic criteria [ABI ≤ 0.90] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until participant stopped due to intolerable claudication pain/fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population. Only those participants available at the specified time points were analyzed.|||kilogram-meters||Standard Deviation|Mean
2603070|NCT02135848|Secondary|Change From Baseline in Total Number of Contractions to Onset of Claudication|At Visit 1 (-21 to -10 days), the participant was introduced to the bilateral heel raise test (BHRT). Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg. Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. The index leg was defined as the leg that met the inclusion symptomatic and hemodynamic criteria (ankle brachial index [ABI] ≤ 0.90) with the lowest ABI considered if both legs were affected. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values.|Baseline (Day 1) to Day 39|Pharmacodynamic population comprised of all participants who provided pharmacodynamic data, i.e. bilateral heel-raise data or six-minute-walk-test data. Only those participants with data available at the indicated time points were analyzed.|||Contractions||Standard Deviation|Mean
2603071|NCT02135848|Primary|Number of Participants With Clinical Hematology Abnormalities of Potential Clinical Importance|Hematology parameters included platelet count, red blood cell (RBC) count, white blood cell WBC count (absolute), hemoglobin, hematocrit, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils and basophils. Number of participants with clinical hematology abnormalities of potential clinical importance are presented.|Up to 67 days|Safety Population.|||Participants|||Count of Participants
2603072|NCT02135848|Primary|Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance|Clinical chemistry analyte of potential clinical concern included albumin, calcium, creatinine, glucose, magnesium, phosphorus, potassium, sodium and bicarbonate. Number of participants with clinical chemistry abnormalities of potential clinical importance are presented.|Up to 67 days|Safety Population.|||Participants|||Count of Participants
2603073|NCT02135848|Primary|Number of Participants With Vital Signs of Potential Clinical Importance|Vital signs included heart rate, systolic and diastolic blood pressure and were performed with the participant in a supine position after the participant had rested for at least 5 minutes. Number of participants with vital signs of potential clinical importance are presented.|Up to 39 days|Safety Population.|||Participants|||Count of Participants
2603074|NCT02135848|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Twelve lead ECGs were recorded with the participant lying supine, having rested in this position for at least 5 minutes before each recording. Full 12 lead ECGs were recorded using an ECG device that automatically calculated the heart rate and measured PR, QRS, RR, QT and QT, QT corrected by Bazett's formula (QTcB) and QT corrected by Fridericia's formula (QTcF) intervals. Number of participants with abnormal (not clinically significant [NCS] and clinically significant [CS]) ECG findings are presented.|Up to 39 days|Safety Population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Count of Participants
2603105|NCT02135445|Secondary|Percentage of Participants Who Have Recovered to >280 ng/dL Testosterone||Day 1 Week 25 up to Day 1 Week 37|Safety population included all participants who received at least one dose of study medication.|||percentage of participants|||Number
2603075|NCT02135848|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to 67 days|Safety population which comprised of all participants who received at least one dose of study medication.|||Participants|||Count of Participants
2603076|NCT02135692|Secondary|Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Hematology Parameters at Any Time Post-Baseline|"Blood samples were collected to assess hematology laboratory parameters. Number of participants with Potential Clinical Importance values for change from Baseline relative to the reference range at any time post-Baseline are presented. Any time post Baseline = all visits (including scheduled and unscheduled) post-Baseline. Participants are counted in the category that their value changes to (low, normal or high), unless there was no change in their category. If lab value category was unchanged, participants were recorded in the To Normal or No Change category."|Baseline (Week 0) to Week 172|AT Population|||Participants|||Count of Participants
2603077|NCT02135692|Secondary|Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline|"Blood samples were collected to assess clinical chemistry laboratory parameters. Number of participants with Potential Clinical Importance values for change from Baseline relative to the reference range at any time post-Baseline are presented. Any time post Baseline = all visits (including scheduled and unscheduled) post-Baseline. Participants are counted in the category that their value changes to (low, normal or high), unless there was no change in their category. If lab value category was unchanged, participants were recorded in the To Normal or No Change category. Alanine Aminotransferase=ALT. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)."|Baseline (Week 0) to Week 172|AT Population|||Participants|||Count of Participants
2603078|NCT02135692|Secondary|Number of Participants With Positive Anti-mepolizumab Binding Antibodies (ADA) and Neutralizing Antibodies (NAb)|Blood samples were collected for the determination of ADA just prior to administration of mepolizumab. Samples that tested positive for anti-mepolizumab antibodies were further tested for the presence of NAb. The highest value post-Baseline visit are based on each participant's highest post-Baseline titer. NAb assay result was only presented for participants with positive ADA assay. Highest value post-Baseline would be positive for a participant who had both negative and positive post-Baseline results. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0) to Week 172|AT Population|||Participants|||Count of Participants
2603079|NCT02135692|Secondary|Change From Baseline in Pulse Rate|Vital sign measurements including pulse rate was done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value.|Baseline (Week 0) to Week 168|AT Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Beats per minute||Standard Deviation|Mean
2603080|NCT02135692|Secondary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure|Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value.|Baseline (Week 0) to Week 168|AT Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Millimeter of mercury||Standard Deviation|Mean
2603081|NCT02135692|Secondary|Number of Participants With Maximum Change From Baseline in QTcB and QTcF Interval for ECG Assessed at Any Time Post Baseline|Twelve-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Participants with maximum change from Baseline were summarised at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial.|Baseline (Week 0) to Week 172|AT Population|||Participants|||Count of Participants
2603082|NCT02135692|Secondary|Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for 12-lead Electrocardiogram (ECG)|Twelve-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)..|Baseline (Week 0) to Week 172|AT Population|||Milliseconds||Standard Deviation|Mean
2603106|NCT02135445|Secondary|Percentage of Participants Who Have Recovered to Baseline Value of Testosterone||Up to Day 1 Week 37|Safety population included all participants who received at least one dose of study medication.|||percentage of participants|||Number
2603083|NCT02135692|Secondary|Number of Participants With AEs Including Both Systemic (Allergic and Non-allergic) and Local Site Reactions|AEs were collected from the Baseline visit until the follow-up visit (Week 172). Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab. Number of participants with AEs including both systemic (i.e. allergic/immunoglobulin (Ig)E-mediated and non-allergic) and local site reactions have been presented.|Baseline (Week 0) to Week 172|AT Population|||Participants|||Count of Participants
2603084|NCT02135692|Secondary|Number of Participants Hospitalized Due to Adverse Events Including Asthma Exacerbations|AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Number of participants requiring hospitalization due to an on-treatment serious adverse event including asthma exacerbations are presented. On-treatment SAEs are the events occurring on/after the first dose of mepolizumab date and before/on last dose of mepolizumab + 28 days.|Baseline (Week 0) to Week 172|AT Population|||Participants|||Count of Participants
2603085|NCT02135692|Secondary|Number of Participants Withdrawn From the Study Due to Lack of Efficacy and Adverse Events|AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Number of participants withdrawn due to lack of efficacy and adverse events from the study have been presented.|Baseline (Week 0) to Week 172|AT Population|||Participants|||Count of Participants
2603086|NCT02135692|Secondary|Mean Change From Baseline in On-treatment Clinic Pre-bronchodilator FEV1|FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at Baseline and Weeks 24, 48, 72, 96, 120, 144 and 168. Spirometry was performed within 1 hour of the Baseline assessment. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Data between first dose date and earliest of Withdrawal date/last dose + 28 days considered on-treatment.|Baseline (Week 0) to Week 168|AT Population|||Milliliter||Standard Deviation|Mean
2603087|NCT02135692|Secondary|Mean Change From Baseline in Asthma Control Questionnaire (ACQ)-5 On-treatment Score|The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma control. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze). The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 5 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value.|Baseline (Week 0) to Week 168|AT Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2603088|NCT02135692|Primary|Number of Participants With Any On-treatment Adverse Event (AE) or On-treatment Serious AE (SAE)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose+28 days.|Baseline (Week 0) to Week 172|AT Population|||Participants|||Count of Participants
2603089|NCT02135692|Primary|Annualized Rate of On-treatment Exacerbations Per Year|Exacerbations are defined as the worsening of asthma which requires use of systemic corticosteroids intravenous (IV) or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit. On-Treatment data between first dose date and earliest of Withdrawal date/last dose + 28 days was considered for analysis. Analysis of the number of exacerbations was performed using a negative binomial generalized linear model.|Baseline (Week 0) to Week 172|As Treated (AT) Population. AT Population included all participants who received at least one dose of mepolizumab within study 201312.|||Exacerbations per year||95% Confidence Interval|Mean
2603090|NCT02135614|Secondary|Rate of Unplanned Medical Encounters|The adjusted rate of unplanned medical encounters (clinic visits, emergency room visits, urgent care visits, and rehospitalizations) related to a respiratory illness after initial hospital discharge through Day 28 will be assessed. Event rate was calculated as the total number of unplanned medical encounters divided by the total number of participants. The mean values presented were adjusted for stratification factor.|Up to Day 28|Evaluable Analysis Set: all randomized participants who received at least 1 dose of study medication, had an RSV viral load greater than lower limit of quantification (LLOQ) of the RT-qPCR assay in the Day 1 nasal-swab sample, and had a minimum of 3 quantifiable samples (including baseline) within a 5 day period.|||encounters per participant||95% Confidence Interval|Number
2603092|NCT02135614|Secondary|Time-weighted Average Change in the Flu-PRO Score From Baseline to Day 5|The Flu-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza. Flu-PRO Score was calculated as the mean of 38 individual scores. Individual scores ranged from 0 (no symptoms) to 4 (worst symptoms). The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.|Baseline to Day 5|Participants in the Evaluable Analysis Set with available data were analyzed.|||units on a scale||Standard Error|Mean
2603093|NCT02135614|Primary|Time-Weighted Average Change in Respiratory Syncytial Viral (RSV) Load From Baseline to Day 5|The time-weighted average change, often referred to as the DAVG, provides the average viral burden change from baseline. The mean values presented were calculated using the ANCOVA model and are adjusted for baseline value and stratification factor.|Baseline to Day 5|Evaluable Analysis Set: all randomized participants who received at least 1 dose of study medication, had an RSV viral load greater than lower limit of quantification (LLOQ) of the RT-qPCR assay in the Day 1 nasal-swab sample, and had a minimum of 3 quantifiable samples (including baseline) within a 5 day period.|||log10 copies/mL||Standard Error|Mean
2603094|NCT02135445|Secondary|Change From Baseline in 25-item Prostate Cancer-specific Questionnaire Supplement (EORTC QLQ-PR25) Score|EORTC QLQ-PR25 : EORTC module designed to supplement the QLQ-C30 for any application in prostate cancer. It Consist of 25 questions distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Questions used 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).|Baseline and last post-baseline value up to Week 37|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.|||units on scale||Standard Error|Least Squares Mean
2603095|NCT02135445|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Score|EORTC QLQ-C30 included 30 questions comprising 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea/vomiting), single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) and a global health and QOL scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'Very poor' to 7 'Excellent'). All domain scores were calculated as an average of item scores and transformed to 0-100 score range where a high score from 0-100 indicates: A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.|Baseline and last post-baseline value up to Week 37|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.|||units on scale||Standard Error|Least Squares Mean
2603096|NCT02135445|Secondary|Percent Change From Baseline in Aging Male's Symptoms (AMS) Total Scale Score|AMS scale is a self-administered questionnaire used to 1) assess symptoms of aging (independent from those that are disease related) between groups of males under different conditions; 2) evaluate the severity of symptoms over time; and 3) measure changes before and after androgen therapy. Each question was answered between none (1) to extremely severe (5) for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total score is sum of all the item scores and range from 17 (minimum) to 85 (maximum), where high score indicated high level of symptoms.|Day 1 of Weeks 5, 13, 25, 29, 33 and 37|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.|||percent change||Standard Deviation|Mean
2603097|NCT02135445|Secondary|Serum Sex Hormone-Binding Globulin (SHBG) Level||Baseline, Day 1 of Week 2, 5, 13, 25 and 29|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.|||nmol/L||Standard Deviation|Mean
2603098|NCT02135445|Secondary|Serum Follicle-Stimulating Hormone (FSH) Level||Baseline, Day 1 of Week 2, 5, 13, 25 and 29|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.|||International units per liter (IU/L)||Standard Deviation|Mean
2603099|NCT02135445|Secondary|Serum Luteinizing Hormone (LH) Level||Baseline, Day 1 of Weeks 2, 3, 5, 9, 13, 17, 21, 25, 29, and 37|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.|||milli-international units per milliliter||Standard Deviation|Mean
2603100|NCT02135445|Secondary|Plasma Concentrations of TAK-385||Day 1 Week 1, 2, 3, 5, 9, 13, 17, 25, 33, 37: Pre-dose; Day 1 Week 5, 13: 2 hrs Post-dose; Day 4 Week 1: Pre-dose|Safety population where TAK-385 assessments were available. Safety population included all participants who received at least one dose of study medication.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2603101|NCT02135445|Secondary|Serum PSA Concentration||Day 1 of Week 13, 25, 29, 33 and 37|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.|||mcg/L||Standard Deviation|Mean
2603102|NCT02135445|Secondary|PSA Nadir||Baseline up to Day 1 Week 25|Safety population included all participants who received at least one dose of study medication.|||microgram per liter (mcg/L)||Standard Deviation|Mean
2603103|NCT02135445|Secondary|Percent Change From Baseline in Serum PSA Concentration||Baseline, Day 1 of Week 2, 3 , 5, 9, 13, 17, 21, 25, 29, 33 and 37|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.|||percent change||Standard Deviation|Mean
2603104|NCT02135445|Secondary|Number of Participants With PSA Response of >=50% and >=90% Reduction|Prostate-specific Antigen (PSA) response was defined as 50% and 90% reduction from baseline in serum PSA levels.|Day 1 Week 13|Safety population included all participants who received at least one dose of study medication.|||participants|||Number
2603107|NCT02135445|Secondary|Estimated Time to Testosterone Recovery (TTR)|TTR is defined as the time from 1 day after the last dose of TAK-385 or 4 weeks plus 1 day after the last dose of degarelix to testosterone recovery. Testosterone recovery is defined as back to baseline or >280 ng/dL whichever occurs first. TTR was determined during 12 weeks after the discontinuation of androgen deprivation therapy (ADT).|Up to Day 1 Week 37|Safety population included all participants who received at least one dose of study medication.|||days||95% Confidence Interval|Median
2603108|NCT02135445|Secondary|Time to Achieve Profound Castration|Time to profound castration is defined as days from first dose to first testosterone measurement that is <20 ng/dL.|Baseline up to Week 37|Safety population included all participants who received at least one dose of study medication.|||days||95% Confidence Interval|Median
2603109|NCT02135445|Secondary|Time to Achieve Effective Castration|Time to effective castration is defined as days from first dose to first testosterone measurement that is <50 ng/dL.|Baseline up to Week 37|Safety population included all participants who received at least one dose of study medication.|||days||95% Confidence Interval|Median
2603110|NCT02135445|Secondary|Average Percent Change in Prostate Size|Percent change in prostate size was assessed at a follow up visit between Day 1 Week 9 to Day 1 Week 13.|Baseline, Day 1 Week 9 to Day 1 Week 13|Safety population where baseline and post-baseline assessments were available. Safety population included all participants who received at least one dose of study medication.|||percent change||Standard Deviation|Mean
2603111|NCT02135445|Secondary|Number of Participants Reporting One or More TEAEs and Serious Adverse Events (SAEs)||Baseline up to Week 29|Safety population included all participants who received at least one dose of study medication.|||participants|||Number
2603112|NCT02135445|Secondary|Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Urinalysis||Baseline up to Week 29|Safety population included all participants who received at least one dose of study medication.|||participants|||Number
2603113|NCT02135445|Secondary|Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings||Baseline up to Week 29|Safety population included all participants who received at least one dose of study medication.|||participants|||Number
2603114|NCT02135445|Secondary|Number of Participants With TEAEs Related to Physical Findings||Baseline up to Week 29|Safety population included all participants who received at least one dose of study medication.|||participants|||Number
2603115|NCT02135445|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs||Baseline up to Week 29|Safety population included all participants who received at least one dose of study medication.|||participants|||Number
2603116|NCT02135445|Primary|Percentage of Participants With Effective Castration Rate Over 25 Weeks|Castration rate is defined as the observed percentage of participants who have testosterone concentrations less than (<) 50 nanogram per deciliter (ng/dL) (1.73 nanomole per liter [nmol/L]) at all scheduled visits.|Day 1 Week 5 up to Day 1 Week 25|Safety population included all participants who received at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2603117|NCT02135432|Other Pre-specified|Pharmacokinetics as Described by AUC12 of Subjects Receiving Ivacaftor||baseline to 2 weeks|||||||
2603118|NCT02135432|Secondary|Change in COPD as Measured by Change in Percentage of FEV1 as Measured in Each Group|Spirometry will be analyzed by ATS criteria, and the best of three reproducible efforts will be used to calculate FEV1 in comparison to Hankinson standards. The primary analysis will be the change in FEV1% from day 0 to day 14 within subject, and will be tested against the null hypothesis that no change occurs using a paired t-test unless the distributions are notably skewed, in which case the non-parametric Wilcoxon signed-rank test will be implemented due to small sample size.|baseline to 2 weeks||||percentage of FEV1||Standard Deviation|Mean
2603119|NCT02135432|Secondary|Number of Adverse Events Experienced by the Ivacaftor Subjects and Placebo Subjects.|Number of adverse events per subject in each the Ivacaftor subjects and placebo subjects|baseline to 2 weeks||||adverse events|||Number
2603120|NCT02135432|Secondary|Change in COPD as Measured by Nasal Potential Difference|Evaluate the efficacy of ivacaftor treatment in patients with COPD including measures of CFTR activity and clinical outcome as measured by change in nasal potential difference measurement in each group. These data will be used to test the null hypothesis of no change in nasal potential difference (ΔLow Chloride plus isoproterenol) using a paired t-test unless the distributions are notably skewed, in which case the non-parametric Wilcoxon signed-rank test will be implemented due to small sample size.|baseline to 2 weeks||||millivolts||Standard Deviation|Mean
2603121|NCT02135432|Primary|Change in COPD as Measured by the Sweat Analysis in Each Group|sweat analysis is measured by performing a sweat test in each participant. The primary analysis will compare the within group change in sweat chloride before (day 1) and after (day 14) ivacaftor or placebo administration and will be used to test the null hypothesis of no change in sweat chloride using a paired t-test unless the distributions are notably skewed, in which case the non-parametric Wilcoxon signed-rank test will be implemented due to small sample size.|baseline to 2 weeks|8 patients were analyzed in the ivacaftor Arm because 8 patients were randomized to study drug and only 4 patients were randomized in the placebo arm because 4 patients received placebl|||mmol/L||Standard Deviation|Mean
2603122|NCT02135146|Secondary|Death|Death|Assessed up to 30 days Post-op|Missing participants lost to follow-up.|||Participants|||Count of Participants
2603123|NCT02135146|Secondary|Development of Morbidity|Development of Morbidity, including: acute lung injury, Acute Respiratory Distress, Deep Vein Thrombus, infection, delirium|Up to 7 days||||Participants|||Count of Participants
2603124|NCT02135146|Secondary|Removal of Chest Tubes|Time to removal of Chest Tubes|Post-op up to 48 hours||||minutes||Standard Deviation|Mean
2603125|NCT02135146|Secondary|Length of Surgical Intensive Unit Stay/Hospital Stay|Length of Surgical Intensive Unit Stay/Hospital Stay|Up to 7 days||||days||Standard Deviation|Mean
2603126|NCT02135146|Primary|Development of Pulmonary Edema|The number of participants diagnosed with mild to severe pulmonary edema at any time up to 72 hours after surgery is reported.|Post-op up to 72 hours||||Participants|||Count of Participants
2603198|NCT02134925|Other Pre-specified|Anti‐MUC1 Antibody Titer by ELISA|Comparisons between MUC1 and placebo will be performed using a two‐sample t‐test or Wilcoxon rank sum test, as appropriate. All categorical variables will be analyzed using chi‐square tests or Fisher's exact test.|At approximately week 156|||||||
2603127|NCT02135146|Primary|Development of Renal Injury|"Acute renal injury as defined by the American Kidney Injury Network (AKIN) criteria in the first 72 hours postoperatively (serum creatinine levels). The AKIN scale will be used to assess the presence and severity of acute kidney injury (AKI). The AKIN is a classification/staging system of acute kidney injury developed by the Acute Kidney Injury Network which uses changes in serum creatinine (SCr) and urine output to assess AKI. Stages of acute kidney injury are defined as 1, 2, or 3, with 3 indicating the most severe AKI.~(1) Increase ≥ 0.3 mg per dL (26.52 μmol per L) or ≥ 1.5- to twofold from baseline. (2) Increase > two- to threefold from baseline. (3) Increase > threefold from baseline or ≥ 4.0 mg per dL (353.60 μmol per L) with an acute rise of at least 0.5 mg per dL (44.20 μmol per L)."|Post-op up to 72 hours||||mg/dL||Standard Deviation|Mean
2603128|NCT02135107|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|Safety was assessed by monitoring and recording all adverse events (AEs) and SAEs, regular monitoring of hematology, clinical chemistry, urine values, and regular measurement of vital signs. All AEs were graded on a 3-point scale; 1) mild was defined as discomfort that did not interfere with normal daily activities, 2) moderate was defined as discomfort that interfered with normal activities, and 3) severe was defined as discomfort that interfered with the ability to work or normal daily activities were impossible. SAEs were medical events that led to death, were life-threatening, required hospitalization or prolongation of hospitalization, caused persistent disability, or resulted in a congenital abnormality. TEAEs were AEs with an onset date on or after the first dose of study drug and up to 30 days after receiving the last dose of study drug. Treatment-related AEs were medical events that were considered by the investigator to be possibly or probably related to rabeprazole.|From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days)|Safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Period and had at least one post-dose safety assessment.|||Participants|||Count of Participants
2603129|NCT02135107|Secondary|Frequency of Sleep Disorders During the Maintenance Therapy Period|Sleep disorders were defined as the condition of lack of dead sleep and arousal during sleep arising from heartburn or acid reflux. Evaluation of sleep disorders arising from heartburn or acid reflux included recording if sleep-inducing drugs were being taken before enrollment; their type, method of use, and dosage. It was requested that no changes in sleep-inducing drug be made after enrollment. Sleep disorders were rated from 0-day (no) to 7-day (always). Heartburn was evaluated prior to 7 days of each visit.|From Week 4 up to Week 52|Central assessment FAS|||Percentage of participants|||Number
2603130|NCT02135107|Secondary|Percentage of Participants With Sleep Disorders During the Maintenance Therapy Period|"Sleep disorders were defined as the condition of lack of dead sleep and arousal during sleep arising from heartburn or acid reflux. Sleep disorders during each of the 7-day periods immediately before visiting the hospital were assessed. Evaluation of sleep disorders arising from heartburn or acid reflux included recording if sleep-inducing drugs were being taken before enrollment; their type, method of use, and dosage. It was requested that no changes in sleep-inducing drug be made after enrollment. Sleep disorders were rated from 0-day (no) to 7-day (always). The incidence of sleep disorder was tabulated by an analysis classifying the stages into two groups: No (0 days with sleep disorder) and Yes (1 or more days with sleep disorder). Heartburn was evaluated prior to 7 days of each visit."|From Week 4 up to Week 52|Central assessment FAS. Participants who did not have sleep disorder due to nighttime heartburn or swallowing at the time of maintenance of the Maintenance Therapy Period, participants whose visit data was not missing.|||Percentage of participants|||Number
2603131|NCT02135107|Secondary|Severity of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period|"A comparison of the rabeprazole (10 mg once daily group) and the rabeprazole (10 mg twice daily group) was performed for participants who did not exhibit daytime or nighttime heartburn at Week 0 of the Maintenance Therapy Period. The presence or absence of heartburn was assessed by the investigators during medical interviews. The heartburn incidence during each of the 7-day periods immediately before visiting the hospital was assessed on a scale of five stages based on the number of days with symptoms: 0 (no symptoms), 1 to 2 (occasional symptoms), 3 to 4 (sometimes had symptoms), 5 to 6 (often had symptoms), and 7 (always had symptoms). The incidence was tabulated by an analysis classifying the states into two groups: no symptom group (0 days with symptoms) and with symptoms group (1 day or more with symptoms). The severity of heartburn was as below: Mild (feel heartburn but tolerable), Moderate (feel heartburn and hard), and Severe (feel heartburn and terrible)."|From Week 4 up to Week 52|Central assessment FAS - LOCF|||Percentage of participants|||Number
2603132|NCT02135107|Secondary|Frequency of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period|A comparison of rabeprazole 10 mg once daily group and the rabeprazole 10 mg twice daily group shall be performed for participants who did not exhibit daytime or nighttime heartburn at 0 weeks of the maintenance therapy period. Daytime and nighttime heartburn, and nighttime sleep disorders shall likewise be compared. For the participants who had recurrence, values at the final evaluation were imputed using a last observation carried forward (LOCF) method.|From Week 4 up to Week 52|Central assessment FAS|||Percentage of participants|||Number
2603133|NCT02135107|Secondary|Percentage of Participants With Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period|A comparison of the rabeprazole 10 mg once daily group and the rabeprazole 10 mg twice daily group was performed for participants who did not exhibit daytime or nighttime heartburn at Week 0 of the Maintenance Therapy Period. Heartburn is a burning sensation in the stomach or lower chest; it is worsened by bending or pressure on the abdomen. Heartburn frequency was rated from 0-day (no) to 7-day (always) and severity was graded on a 3-point scale (mild, moderate, severe). Heartburn was evaluated in the daytime (from wake-up time to time for bed) and nighttime (from time for bed to wake-up time).|From Week 4 up to Week 52|Central assessment FAS - LOCF. Analysis was carried out on participants who were determined to be free of symptoms at maintenance therapy entry.|||Percentage of participants|||Number
2603134|NCT02135107|Secondary|Cumulative Non-recurrence Rate at Week 52|Non-recurrence rate at Week 52 was estimated using the Kaplan-Meier method.|Week 52|Central assessment FAS|||Percentage of non-recurrence||95% Confidence Interval|Number
2603199|NCT02134925|Secondary|Number of Patients With at Least a 2‐Fold Increase in the IgG Ratio|The frequency and percentage of patients with at least a 2‐fold increase in the IgG Ratio will be calculated and compared between the MUC1 vaccine and placebo. The Fisher's exact test will be used.|At 12 weeks||||Participants|||Count of Participants
2603135|NCT02135107|Secondary|Rate of Non-recurrence at Weeks 12 and 24|The non-recurrence rate (up to 52 weeks) was determined by the endoscopy central review panel who were blinded to the investigator's assessment, based on the modified Los Angeles Classification using endoscopy photos were submitted by each of the institutions. Participants showing Grade A or above based on the modified Los Angeles Classification were included as a recurrence. The 95% CI was calculated by normal approximation.|Weeks 12 and 24|Central assessment FAS. Data analysis excluded participants with missing data.|||Percentage of participants||95% Confidence Interval|Number
2603136|NCT02135107|Primary|Rate of Non-recurrence at Week 52|The non-recurrence rate (at 52 weeks) was determined by the endoscopy central review panel who were blinded to the investigator's assessment, based on the modified Los Angeles Classification using endoscopy photos were submitted by each of the institutions. Participants showing Grade A or above based on the modified Los Angeles Classification were included as a recurrence.|Week 52|Central assessment Full Analysis Set (FAS) was defined as all randomized participants who received at least one dose of the study drug, and from whom the results of at least one endoscopic assessment was available. Data analysis excluded participants with missing data.|||Percentage of participants||95% Confidence Interval|Number
2603137|NCT02135094|Secondary|Comparison of Pain Level Using Global Rating of Change (GROC) Scale.|"Participants were asked to report how their body feels overall compared to the day before, on days when the ultrasound device (or placebo) were applied. The score was reported after the 4-hour treatment completion and rated on a 15-point global rating of change scale, with -7 being a very great deal worse than the day before, 0 being no change from the day before, and +7 being a very great deal better than the day before. The weekly average GROC and average GROC for the entire study (Overall) were assessed."|Week 1, Week 2, Week 3, Week 4, Overall||||units on a scale||Standard Deviation|Mean
2603138|NCT02135094|Secondary|Change in Pain Rated on Numeric Rating Scale (NRS) From Pre-treatment to 30 Minutes Into Treatment, 2 Hours Into Treatment, and Post-treatment (4 Hours Into Treatment)|The numeric rating scale (NRS) was used to assess pain before treatment, 30 minutes into treatment, 2 hours into treatment, and post-treatment. NRS range was from 0-10 with 0 being in no pain and 10 the worst pain possible. Change in pain was calculated by subtracting intra-treatment and post-treatment average scores from pre-treatment average score.|Day 1 through Week 4||||units on a scale||95% Confidence Interval|Mean
2603139|NCT02135094|Secondary|Pain on the Numeric Rating Scale Assessed Before, During, and After Treatment.|Participants recorded pain rated on the numeric rating scale (NRS) at 4 time points: before treatment, 30 minutes into treatment, 2 hours into treatment, and directly after treatment. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible. The average time point scores across the study is used to assess pain during treatment.|Day 1 through Week 4||||units on a scale||Standard Deviation|Mean
2603140|NCT02135094|Primary|Pain on the Numeric Rating Scale (NRS) Change From Day 1 Pre-treatment.|The Day 1 pre-treatment score was used to find the change in pain each week, rated on the numeric rating scale (NRS). NRS was rated from 0-10 with 0 being in no pain and 10 the worst pain possible. Weekly averaged post-treatment scores were subtracted from Day 1 pre-treatment score.|Day 1 through Week 1, Week 2, Week 3, and Week 4||||units on a scale||95% Confidence Interval|Mean
2603141|NCT02135094|Primary|Pain on the Numeric Rating Scale (NRS)|Patients applied the ultrasound device when trapezius muscle pain exceeds a score of 3 or higher by numeric rating scale (NRS). NRS range was 0-10 with 0 being no pain and 10 the worst pain possible. Device maybe be worn safely for 4 h per day for 7 days a week. Participants recorded NRS score daily (pre-treatment) and on days when the device was applied participants recorded pain 30 minutes into treatment, 2 hours into treatment and post-treatment (after 4 hours). The post-treatment score is used to find the week average and standard deviation.|Week 1, Week 2, Week 3, Week 4||||units on a scale||Standard Deviation|Mean
2603142|NCT02135029|Secondary|Percentage of Participants Discontinued Due to Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations||Baseline (Day 1) up to Week 30|Safety analysis set included all participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
2603143|NCT02135029|Secondary|Anti-drug Antibody (ADA) and Neutralizing Anti-body (nAb) Titer Level in Participants Who Tested Positive for ADA and nAb Respectively|Titer levels of participants who tested positive for ADA and nAb are reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint.|Week 4, 12, 24 and 30 (Follow-up)|Safety analysis set: all participants who received at least 1 dose of study treatment. Here, 'N' signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time point for the arm. Participants who received PF-04950615 150 mg were evaluable for this outcome measure.|||titer||Standard Deviation|Mean
2603144|NCT02135029|Secondary|Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (nAb)|Participants with at least one positive ADA titer greater than or equal to (>=) 6.23 or positive nAb titer >=4.32 were reported. Titers are expressed as log2 reciprocal dilution at assay cutpoint.|Baseline up to Week 30|Safety analysis set included all participants who received at least 1 dose of study treatment. Here, 'N' signifies those participants who were evaluable for this outcome measure. Participants who received PF-04950615 150 mg were evaluable for this outcome measure.|||participants|||Number
2603145|NCT02135029|Secondary|Number of Participants With Adverse Events Related to Type 1 and 3 Hypersensitivity Reactions, Injection Site Reactions, Myalgia, Myopathy, Creatinine Kinase (CK) and Liver Function Tests (LFT) Elevations||Baseline (Day 1) up to Week 30|Safety analysis set included all participants who received at least 1 dose of study treatment.|||participants|||Number
2603146|NCT02135029|Secondary|Plasma PF-04950615 Concentrations at Weeks 12 and 24|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.4 micrograms per milliliter [mcg/mL]) to zero. Participants who received PF-04950615 150 mg were evaluable for this outcome measure.|Week 12 and 24|Safety analysis set included all participants who received at least 1 dose of study treatment. Here, 'N' signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time point for the arm.|||mcg/mL||Standard Deviation|Mean
2603147|NCT02135029|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24||Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants|||Number
2603148|NCT02135029|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Weeks 12 and 24||Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percentage of participants|||Number
2603149|NCT02135029|Secondary|Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB)/Apolipoprotein A-I (ApoA-I) Ratio at Weeks 12 And 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||ratio||Standard Deviation|Mean
2603150|NCT02135029|Secondary|Absolute Change From Baseline in Fasting Total Cholesterol (TC)/ High Density Lipoprotein Cholesterol (HDL-C) Ratio at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||ratio||Standard Deviation|Mean
2603151|NCT02135029|Secondary|Absolute Change From Baseline in Lipoprotein (A) (Lp[A]) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2603152|NCT02135029|Secondary|Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2603153|NCT02135029|Secondary|Absolute Change From Baseline in Fasting Triglycerides (TG) at Week 12||Baseline, Week 12|Due to changes in planned analyses the data was not collected for this outcome measure.||||||
2603154|NCT02135029|Secondary|Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified timepoint for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2603155|NCT02135029|Secondary|Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2603156|NCT02135029|Secondary|Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2603157|NCT02135029|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2603158|NCT02135029|Secondary|Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
2603159|NCT02135029|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
2603160|NCT02135029|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
2603161|NCT02135029|Secondary|Percent Change From Baseline in Fasting Triglycerides (TG) at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
2603162|NCT02135029|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24||Baseline, Week 24|FAS included all participants who were randomized. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||percent change||Standard Deviation|Mean
2603163|NCT02135029|Secondary|Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
2603164|NCT02135029|Secondary|Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
2603165|NCT02135029|Secondary|Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
2603166|NCT02135029|Secondary|Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
2603167|NCT02135029|Secondary|Percent Change From Baseline in Fasting Total Cholesterol (TC) at Weeks 12 and 24||Baseline, Week 12, 24|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
2603168|NCT02135029|Primary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||percent (%) change||Standard Deviation|Mean
2603169|NCT02135016|Secondary|The Block Level of Epidural Anesthesia|The block level 20mins after epidural anesthesia and it is verified by the loss of sensation to alcohol swab before target controlled infusion of propofol.It is the number of block segments.The block level varies from 0 to 10(0, no block level; 1 to 5, narrow block level;6 to 10, wide block level).|20 mins after epidural anesthesia||||units on a scale||Standard Deviation|Mean
2603170|NCT02135016|Secondary|The Heart Rate|The heart rate of each patient will be recorded at three different four points, as follows, baseline(the awake phase before epidural anesthesia), 10mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia).|The participants will be followed for the duration of anesthesia induction, an expected average of half an hour||||beats per minute||Standard Deviation|Mean
2603171|NCT02135016|Secondary|The Mean Blood Pressure|The mean arterial pressure of each patient will be recorded at four different time points, as follows, baseline(the awake phase before epidural anesthesia), 10 mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia).|The participants will be followed for the duration of anesthesia induction, an expected average of half an hour||||mmHg||Standard Deviation|Mean
2603172|NCT02135016|Secondary|The Bispectral Index|The bispectral index (BIS) of each patient will be recorded at four different time points,as follows, baseline(the awake phase before epidural anesthesia),10 mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia). BIS values varies from 0 to 100(0, no cerebral activity; 40 to 60, general anesthesia; 60 to 85, sedated; 85 to 100, awake).|The participants will be followed for the duration of anesthesia induction, an expected average of half an hour||||units on a scale||Standard Deviation|Mean
2603173|NCT02135016|Primary|The Effect-site Concentration of Propofol|The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.|The participants will be followed for the duration of anesthesia induction, an expected average of half an hour||||µg/ml||Standard Deviation|Mean
2603174|NCT02134977|Secondary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The event was occurred in breast cancer female.|Baseline up to Week 48|Safety analysis set was defined as participants who received at least one dose of study medication.|||participants|||Number
2603175|NCT02134977|Secondary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to Week 48|Safety analysis set was defined as participants who received at least one dose of study medication.|||participants|||Number
2603176|NCT02134977|Secondary|Percentage of Participants With Positive Change in Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Was the change in agents good? and the options of the answers were very good, somewhat good, whether or not the change in agents was good cannot be determined, somewhat bad, very bad."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||percentage of participants|||Number
2603177|NCT02134977|Secondary|Percentage of Participants With Change in Pain at the Time of Injection Due to the Change in Medicinal Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Was there a change in pain at the time of injection due to the change in agents? and the options of the answers were significantly relieved, slightly relieved, whether or not the pain worsened or was relieved cannot be determined, worsened slightly, and worsened significantly."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||percentage of participants|||Number
2603178|NCT02134977|Secondary|Percentage of Participants With Change in Adverse Drug Reactions Due to the Change in Medicinal Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Was there a change in adverse drug reactions (e.g., menopausal-like symptoms such as hot flushes, injection-site abnormalities) due to the change in agents? and the options of the answers were events became much less severe, events became less severe, whether or not the events became severe cannot be determined, events became slightly more severe, and events became very severe."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||percentage of participants|||Number
2603179|NCT02134977|Secondary|Percentage of Participants Who Worried About the Effect of the Medicinal Agent|"The question was with regard to the assessment of convenience associated with the changes in agents, The change in agents reduced the frequency of injections by one third; for this reason, did you worry about the effect? and the options of the answers were not at all worried, not too worried, no thought either way, somewhat worried, and very worried."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||percentage of participants|||Number
2603250|NCT02134119|Secondary|Hematological Measures - Hemoglobin|as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)||||g/dL||Standard Deviation|Mean
2603251|NCT02134119|Secondary|Hematological Measures - Hematocrit|as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days||||percent of red blood cells in blood||Standard Deviation|Mean
2603180|NCT02134977|Secondary|Percentage of Participants With Relief From Financial Burden Due to the Change in Medicinal Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Did you feel relief from financial burden (example, 3 months' drug costs and transportation fee) due to the change in agents? and the answers were categorized as felt extreme relief, felt slight relief, no feeling either way, felt little relief, felt no relief. The sum of all the categories is not 100% because of rounding error."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||percentage of participants|||Number
2603181|NCT02134977|Secondary|Percentage of Participants Who Felt Relief From Physical and Emotional Burden|"The question was with regard to the assessment of convenience associated with the changes in agents, The change in agents reduced the frequency of injections by one third; for this reason, did you feel relief from physical and emotional burden? and the answers were categorized as felt extreme relief, felt slight relief, no feeling either way, felt little relief, felt no relief."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||percentage of participants|||Number
2603182|NCT02134977|Secondary|Percentage of Participants With Reduction in Frequency of Medical Visits Due to Change in Medicinal Agents|"The question was with regard to the assessment of convenience associated with the changes in agents, Did the change in agents reduce the frequency of your medical visits? and the answers were categorized as very much reduced, somewhat reduced, unchanged. Change in medicinal agents means participants with a historical diagnosis of premenopausal breast cancer who switched to leuprorelin acetate sustained-release 11.25 mg injection kit from a 4-week adjuvant therapy with a LH-RHa 1 month depot preparation as part of daily medical practice."|Week 48|Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||percentage of participants|||Number
2603183|NCT02134977|Primary|Score of QOL-ACD-B Items 19, 20 and 21 at Week 48|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). For questionnaire item 19 (Did you feel inferior to your child when you interact with him/her? [due to the impact of illness and treatment]), item 20 (Did you worry about child rearing? [due to the impact of illness and treatment]), and item 21 (Do you worry about pregnancy or delivery? [due to the impact of illness and treatment]), the calculation was based on the score of each item. Each item was scored on a 5-point scale, where 1 was the worst response and 5 was the best.|Week 48|Efficacy assessment population where Week 48 assessment for each item were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||units on a scale||Standard Deviation|Mean
2603184|NCT02134977|Primary|Score of QOL-ACD-B Items 19, 20 and 21 at Week 12|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). For questionnaire item 19 (Did you feel inferior to your child when you interact with him/her? [due to the impact of illness and treatment]), item 20 (Did you worry about child rearing? [due to the impact of illness and treatment]), and item 21 (Do you worry about pregnancy or delivery? [due to the impact of illness and treatment]), the calculation was based on the score of each item. Each item was scored on a 5-point scale, where 1 was the worst response and 5 was the best.|Week 12|Efficacy assessment population where Week 12 assessment for each item were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||units on a scale||Standard Deviation|Mean
2603185|NCT02134977|Primary|Score of QOL-ACD-B Items 19, 20 and 21 at Baseline|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). For questionnaire item 19 (Did you feel inferior to your child when you interact with him/her? [due to the impact of illness and treatment]), item 20 (Did you worry about child rearing? [due to the impact of illness and treatment]), and item 21 (Do you worry about pregnancy or delivery? [due to the impact of illness and treatment]), the calculation was based on the score of each item. Each item was scored on a 5-point scale, where 1 was the worst response and 5 was the best.|Baseline|Efficacy assessment population where baseline assessment for each item were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||units on a scale||Standard Deviation|Mean
2603186|NCT02134977|Primary|Score of QOL-ACD-B at Week 48|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Total score for QOL-ACD-B is calculated as a sum of 18 items, score range: 18 to 90 where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.|Week 48|Efficacy assessment population where Week 48 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||units on a scale||Standard Deviation|Mean
2603187|NCT02134977|Primary|Score of QOL-ACD-B at Week 12|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Total score for QOL-ACD-B is calculated as a sum of 18 items, score range: 18 to 90 where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.|Week 12|Efficacy assessment population where Week 12 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||units on a scale||Standard Deviation|Mean
2603252|NCT02134119|Secondary|Hematological Measures -Hematocrit|as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)||||percent of red blood cells in blood||Standard Deviation|Mean
2603188|NCT02134977|Primary|QOL-ACD Breast (QOL-ACD-B) Score at Baseline|QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Total score was calculated over score range 0-100 for item 1 to 18 as ((a sum of 18 items)/18-1)*25). Score for physical condition and pain was calculated over score range 0-100 for item 1 to 6 as ((a sum of 6 items)/6-1)*25)). Score for health-care and illness satisfaction was calculated over score range 0-100 for item 7 to 10 as ((a sum of 4 items)/4-1)*25)), where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.|Baseline|Efficacy assessment population where baseline assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||units on a scale||Standard Deviation|Mean
2603189|NCT02134977|Primary|QOL-ACD Total and Subscale Score at Week 48|QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale: 5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.|Week 48|Efficacy assessment population where Week 48 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||units on a scale||Standard Deviation|Mean
2603190|NCT02134977|Primary|QOL-ACD Total and Subscale Score at Week 12|QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale:5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.|Week 12|Efficacy assessment population where Week 12 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||units on a scale||Standard Deviation|Mean
2603191|NCT02134977|Primary|Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD) Total and Subscale Score at Baseline|QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale: 5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all [worst response] to 5: very much [best response]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.|Baseline|Efficacy assessment population where baseline assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.|||units on a scale||Standard Deviation|Mean
2603192|NCT02134951|Other Pre-specified|Pharmacological Blood-oxygen-level Dependent (pharmacoBOLD) Response|Compare changes inpharmacoBOLD in response to infusion of ketamine vs. placebo, as measured by resting state functional magnetic resonance imaging. Calculated by post-pre changes, with higher values indicating higher response|Day 14||||BOLD signal units||Standard Error|Mean
2603193|NCT02134951|Primary|Glutamate + Glutamine (Glx) Response|Compare changes in Glx response to infusion of ketamine vs placebo, as measured by proton magnetic resonance spectroscopy (¹H MRS). Calculated by post-pre changes in the Glx over creatinine ratios, with higher values indicating higher Glx/creatinine ratios.|Day 1|Glx response in 1st 15 minutes post ketamine|||Glx over creatinine ratio||Standard Error|Mean
2603194|NCT02134925|Other Pre-specified|Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0.||Up to 3 years|||||||
2603195|NCT02134925|Other Pre-specified|Establishment of a Biospecimen Repository Archive Including Live Cells, Plasma, and Germline DNA for Future Immunologic and Other Assays||Up to 3 years|||||||
2603196|NCT02134925|Other Pre-specified|Change in MUC1 Expression|Descriptive statistics and simple scatter plots will be generated to review the continuous biomarker data. In addition, for continuous biomarker values, the actual and percent change in the level of each of the biomarkers from baseline to post‐baseline time points will be explored within each arm using Wilcoxon signed rank tests, and paired sample t‐tests.|Baseline to up to 3 years|||||||
2603197|NCT02134925|Other Pre-specified|Change in Levels of Circulating MDSC in Peripheral Blood Mononuclear Cells by Flow Cytometry|MDSC levels will be correlated with anti‐MUC1 antibody levels and adenoma recurrence. Descriptive statistics and simple scatter plots will be generated to review the continuous biomarker data. In addition, for continuous biomarker values, the actual and percent change in the level of each of the biomarkers from baseline to post‐baseline time points will be explored within each arm using Wilcoxon signed rank tests, and paired sample t‐tests.|Baseline to up to 3 years|||||||
2603200|NCT02134925|Secondary|Participant-reported Injection Site Reactions - Pain at the Injection Site Without Touching, and Tenderness (Pain at the Injection Site With Touch)|Participant-reported injection site reaction information is collected by the use of a participant-completed Vaccine Report Card. Participant-reported injection site reactions will be compared between study arms and are summarized below for pain at the injection site without touching, and tenderness (pain at the injection site with touch).|Up to 55 weeks|Participants who completed Vaccine Report Card are included in this analysis.|||Participants|||Count of Participants
2603201|NCT02134925|Secondary|Participant-reported Injection Site Reactions - Redness at the Injection Site, Swelling/Induration, Itching at Site, and Skin Warmth at Site|Participant-reported injection site reaction information is collected by the use of a participant-completed Vaccine Report Card. Participant-reported injection site reactions will be compared between study arms and are summarized below for redness at the injection site, swelling/induration, itching at site, and skin warmth at site.|Up to 55 weeks|Participants who completed the Vaccine Report Card are included in this analysis.|||Participants|||Count of Participants
2603202|NCT02134925|Secondary|Booster Response|The key secondary endpoint for Part 2 will assess the booster response at week 55 vs. week 52 for the vaccine as compared to placebo. The IgG ratios are summarized according to the following categories : <1, 1-<1.5, 1.5-<2, and >=2 (1-year response rate).|At week 55|Participants with IgG levels at week 52 and 55 are included in this analysis|||Participants|||Count of Participants
2603203|NCT02134925|Secondary|Adenoma Recurrence Rate|The secondary endpoint for Part 3 will evaluate the adenoma recurrence rate from surveillance exams. The rate is defined as the percentage of participants with adenoma recurrence.|At least one year and up to 3 years|Participants who completed the surveillance exams were included in this analysis.|||percentage of participants|||Number
2603204|NCT02134925|Primary|Change in Anti-MUC1 Immunoglobulin G (IgG) Levels as Determined by Enzyme-linked Immunosorbent Assay (ELISA)|The ratio of the week 12 to week 0 IgG levels will be calculated and compared between the MUC1 vaccine and placebo. The Wilcoxon Rank‐Sum test will be used. For all measurements of response (i.e. the primary endpoint), the 95% confidence intervals will also be provided.|Week 0 to week 12||||IgG ratio||Full Range|Median
2603205|NCT02134912|Secondary|Overall Survival|Differences in OS by treatment arm will be evaluated using a 1-sided log-rank test with significant level of 10%.|Up to 3 years|The one patient that enrolled immediately withdrew consent [enrolled the day before the study closed]. No manuscript will be forthcoming.||||||
2603206|NCT02134912|Secondary|Patterns of Failure|Defined as CNS-only, extra-CNS, and both CNS and extra-CNS progression between the treatment arms. Evaluated within each treatment arm using cumulative incidence curves.|Up to 3 years|The one patient that enrolled immediately withdrew consent [enrolled the day before the study closed]. No manuscript will be forthcoming.||||||
2603207|NCT02134912|Secondary|Response Rates (Confirmed and Unconfirmed) of Crizotinib With Pemetrexed Disodium|Comparisons of response rates will be done using a chi-square test of independence using 10% as the significance threshold. Within each treatment arm, response rates can be estimated to within 13% (with 95% confidence).|Up to 3 years|The one patient that enrolled immediately withdrew consent [enrolled the day before the study closed]. No manuscript will be forthcoming.||||||
2603208|NCT02134912|Secondary|Response Rate (Confirmed and Unconfirmed) With Pemetrexed Disodium Monotherapy|Comparisons of response rates will be done using a chi-square test of independence using 10% as the significance threshold. Within each treatment arm, response rates can be estimated to within 13% (with 95% confidence).|Up to 3 years|The one patient that enrolled immediately withdrew consent [enrolled the day before the study closed]. No manuscript will be forthcoming.||||||
2603209|NCT02134912|Secondary|Incidence of Adverse Events of Crizotinib in Combination With Pemetrexed Disodium, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Comparisons of toxicities rates will be done using a Fisher's exact or chi-squared test of independence, when appropriate using 10% as the significance threshold. Within each treatment arm, any toxicity with at least 5% prevalence has at least a 95% chance of being observed.|Up to 3 years|The one patient that enrolled immediately withdrew consent [enrolled the day before the study closed]. No manuscript will be forthcoming.||||||
2603210|NCT02134912|Primary|PFS Between Patients Randomized to Receive Pemetrexed Disodium Monotherapy Versus Crizotinib and Pemetrexed Disodium Combination Therapy|A stratified log-rank test at the 0.10 level will be used to test the primary hypothesis comparing the two treatment arms.|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years|The one patient that enrolled immediately withdrew consent [enrolled the day before the study closed]. No manuscript will be forthcoming.||||||
2603211|NCT02134717|Secondary|Chemokine Receptor 5 (CCR5) Expression Among These Immune Effector Cells|CCR5 expression among these immune effector cells before and after CCR5 inhibition.|6 weeks|Study was terminated before data were collected for this outcome measure.||||||
2603212|NCT02134717|Secondary|Mononuclear Cell (MNC) Activation and T-cell Differentiation|MNC activation and T-cell differentiation before and after CCR5 inhibition.|6 weeks|Study was terminated before data were collected for this outcome measure.||||||
2603213|NCT02134717|Primary|Total Cell Count and Differentials in Blood and Bronchoalveolar Lavage Fluid Pre- and Post Maraviroc|General indicators of inflammation following chemokine receptor 5 (CCR5) inhibition in blood and bronchoalveolar lavage|6 weeks|Data could not be analyzed||||||
2603214|NCT02134587|Secondary|Quality of ADE Reports|Skills evaluation will be carried out according to the perception of the voluntary regarding the relevance´s degree of the information to be filled in ADE form. Therefore, in the first (prior to educational intervention) and fourth (post-educational intervention period) meetings, subjects will be asked to highlight the fields of ADE form, according to unnecessary, necessary or essential information to be reported. Minimal and desirable criteria to be filled in ADE form preconized by Pan-American Health Organization will be considered gold-standard answers. Scores from zero to ten will be assigned, according to gold-standard answers. Data will be compared, in order to estimate the impact of educational intervention on skills to fill ADE form.|Two days|The subjects were assessed regarding pharmacovigilance´s skills prior to educational interventions and after as well, in order to evaluate the effectiveness of the study in contribute on the improvement of the quality of information inserted on the form.|||percent of correctly filled forms||Full Range|Median
2603215|NCT02134587|Secondary|Knowledge (Awareness) Regarding Pharmacovigilance|Knowledge assessment will be performed by content analysis of answers obtained from questionnaire, being assigned scores from zero to ten. Definitions related to pharmacovigilance of World Health Organization will be considered gold-standard answers. Scores below five will be classified as unsatisfactory, among five and 7.5 were considered regular and above 7.6 satisfactory on the knowledge acquisition.The questionnaire will be applied in the first (prior to educational intervention) and fourth (post-educational intervention period) meetings. Data will be compared, in order to assess the impact of educational intervention on knowledge of health professionals.|Two days|The subjects were assessed regarding pharmacovigilance´s knowledge prior to educational interventions and after as well, in order to evaluate the effectiveness of the study in aware health professionals to report adverse drug events.|||percentage of right answers||Full Range|Median
2603216|NCT02134587|Primary|Absolute Number of ADE Reporting (Change Behavior of Health Professionals)|Investigators are going to verify the numbers of adverse drug events reported by health professionals which was made 12 months before educational intervention. A follow up across 12 months post-educational intervention also will be performed, in order to identify the number of adverse drug events reported by health professionals. Prevalence of ADE in both periods will be estimated and compared, in order to asses the impact of the intervention on change behavior of health professionals.|12 months|Before educational intervention, health professionals reported only three adverse drug events, related to therapeutic failure. However, after the study, the number of reports rise 70-fold, since subjects reported 165 medication errors, 26 adverse drug reactions, 18 quality deviations, 5 therapeutic failure and one off-label use.|||absolute number of adverse drug events|||Number
2603217|NCT02134522|Secondary|Changes in Two Hour Glucose|2 hour glucose measured by an oral glucose tolerance test done at baseline and 12 weeks. Data are presented as mg/dl.|baseline and 12 weeks||||mg/dl|||Number
2603218|NCT02134522|Primary|Changes in Hepatic Fat Content|Abdominal MRI to measure percent liver fat done at baseline and 12 weeks.|baseline and 12 weeks|Presented is the change from baseline to 12 weeks in a single patient.|||percentage of hepatic liver fat|||Number
2603219|NCT02134314|Other Pre-specified|Graft Survival|Number of Participants with Graft Survival at 90 Days Post-Transplant|Day 90 Post-transplant||||Participants|||Count of Participants
2603220|NCT02134314|Other Pre-specified|Rate of Acute Cellular Rejection (ACR)|Number of acute cellular and antibody mediated rejection episodes by day 90.|Up to 90 days post-transplant||||episodes|||Number
2603221|NCT02134314|Other Pre-specified|Patient Survival|Patient survival at 90 days post-transplantation|Up to 90 days post-transplant||||Participants|||Count of Participants
2603222|NCT02134314|Other Pre-specified|Overall Incidence of Serious Adverse Events|Overall incidence of serious adverse events in the C1INH and placebo groups, number of events.|Up to 9 months post-transplant||||events|||Number
2603223|NCT02134314|Secondary|Number of Patients With Delayed Graft Function (DGF) (Categorized by DGF Scale)|"DGF Scale:~Grade 1 - immediate urine production and no need for dialysis with creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation >70%~Grade 2 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation of >70% with need for dialysis~Grade 3 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation <70% with no need for dialysis~Grade 4 - creatinine reduction ratio (CRR) between time 0 of transplantation and day 7 post-transplantation of <70% with need for dialysis."|First 7 days post-transplant||||Participants|||Count of Participants
2603224|NCT02134314|Secondary|Mean Number of Patients on Dialysis|Mean number of patients on dialysis at 15 to 30 days post-transplant|15 to 30 days post-transplantation||||Participants|||Count of Participants
2603225|NCT02134314|Secondary|24h Urine Output|24 hour urine output post-transplantation measured in milliliters|24 hours post-transplant||||milliliters||Standard Deviation|Mean
2603226|NCT02134314|Secondary|Creatinine Clearance|Creatinine clearance calculated based on serum creatinine, milliliters per minute.|Up to 90 days post-transplant||||ml/minute||Standard Deviation|Mean
2603227|NCT02134314|Secondary|Serum Creatinine|Mean serum creatinine on day 90 in mg/dL|Up to 90 days post-transplant||||mg/dL||Standard Deviation|Mean
2603228|NCT02134314|Primary|Number of Dialysis Sessions Per Patient in the First 7 Days Post Transplant.|Mean quantity of dialysis sessions per patient in the first 7 days post transplant.|First 7 days post-transplant||||dialysis sessions||Standard Deviation|Mean
2603229|NCT02134314|Primary|Number of Patients With Serum Creatinine Reduction Ratio of < 30% From 24 to 48 Hours Post-transplant.|Number of patients in the C1INH and placebo groups with serum creatinine reduction of < 30% from 24 to 48 hours post-transplant.|First 7 days post-transplant||||Participants|||Count of Participants
2603230|NCT02134314|Primary|Number of Patients Enrolled Who Require at Least One Session of Dialysis in the First 7 Days Post Transplant.|The proportion of patients enrolled who require at least one session of dialysis in the first 7 days post transplant (excluding those who are dialyzed for hyperkalemia).|First 7 days post-transplant||||Participants|||Count of Participants
2603231|NCT02134314|Primary|Number of Patients Enrolled With Serum Creatinine >3mg/dL on Postoperative Day 5.|Number of participants in the C1INH and placebo groups with serum creatinine >3mg/dL on postoperative day 5|First 7 days post-transplant||||Participants|||Count of Participants
2603232|NCT02134210|Secondary|The Proportion of Subjects With a Durability of Response at Week 48|The proportion of subjects with a durability of response during Part 2. Durability of response was defined as the maintenance of the PASI-50 or greater at Weeks 24, 36, and 48 when compared to baseline (Week 0).|Weeks 24, 36, and 48 when compared to baseline (Week 0).||||percentage of participants|||Number
2603233|NCT02134210|Secondary|Change in Highly Sensitive C-reactive Protein (Hs-CRP; mg/L)|"Change in highly sensitive C-reactive protein (hs-CRP; mg/L) from baseline to Weeks 12, 24, and 48 for subjects with PsA (Psoriatic arthritis) only.~Highly sensitive C-reactive protein For subjects with PsA, change in hs-CRP from baseline to Weeks 12, 24, and 48 was assessed."|Weeks 12, 24, and 48|The population from part 2(weeks 13-48) did not include the full analysis population from part 1.|||mg/L||Standard Deviation|Mean
2603253|NCT02134119|Secondary|Hematological Measures - Hematocrit|as measured by hematocrit (Hct) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|0 days (baseline)||||percent of red blood cells in blood||Standard Deviation|Mean
2603234|NCT02134210|Secondary|Change in Health Assessment Questionnaire-Disability Index (HAQ-DI)|"HAQ-DI - Scales for each question range from 0-3 (0=without any difficulty; 1=with some difficulty; 2=with much difficulty; 3=Unable to do). The total for each category is determined by the highest score (greatest difficulty) for that category. The score for the disability index is the mean of the eight category scores. If more than 2 of the categories or 25% are missing, the scale won't be scored. If fewer than 2 or the categories are missing, the sum of the categories was divided by the number of answered categories."|Weeks 12, 24, and 48|Part 2 of the study(weeks-13-48) did not include the full analysis population from part 1.|||units on a scale||Standard Deviation|Mean
2603235|NCT02134210|Secondary|Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)|"Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D) from baseline to Weeks 12, 24, and 48~The EQ-5D was performed at randomization (Week 0/Day 0), and Weeks 12, 24, and 48. The EQ-5D is a generic (non-disease specific), preference-based health-related quality of life measure based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions)."|Weeks 12, 24, and 48|Part 2 (weeks 13-48) of the study did not include the full analysis population from part 1|||units on a scale||Standard Deviation|Mean
2603236|NCT02134210|Secondary|Change in DLQI (Dermatology Life Quality Index)|"Change in DLQI (Dermatology Life Quality Index) from baseline to Weeks 12, 24, and 48~The DLQI is a 10-question validated questionnaire that was performed at screening, randomization (Week 0/Day 0), and Weeks 12, 24, and 48. It was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life was impaired."|Weeks 12, 24, and 48|Part 2 (weeks 13-48) of the study did not include the full analysis population from part 1|||score on a scale||Standard Deviation|Mean
2603237|NCT02134210|Secondary|Change in Subject's Global Assessment (SGA) of PsO|Change in Subject's Global Assessment (SGA) of PsO from baseline to Weeks 4, 8, 12, 24, 36, and 48. The SGA of PsO was assessed using VAS (visual analog scale in the unit of millimeters) , ranging from 0 (good) to 100 (severe). The SGA was assessed at randomization (Week 0/Day 0) and Weeks 4, 8, 12, 24, 36, and 48, as well as at the Follow-up Visit, if applicable. The change in SGA is the value at baseline minus sum of values at weeks 4, 8, 12, 24, 36, and 48. Since the change in SGA is measured from baseline, a negative value indicates a decrease in overall SGA and better overall assessment of PsO.|Weeks 4, 8, 12, 24, 36, and 48|Part 2 of the study(weeks 13-48) did not include the full analysis population from part 1 of the study.|||units on a scale||Standard Deviation|Mean
2603238|NCT02134210|Secondary|The Proportion of Subjects With a Change in a PSGA (Physician's Static Global Assessment) Score = 0 to 1|"The proportion of subjects with a change in a PSGA (Physician's Static Global Assessment) score = 0 to 1, demonstrating clear or almost clear skin at Weeks 4, 8, 12, 24, 36, and 48;~Minimum: 0 Maximum: 1 Subjects with a clear(0) or almost clear(1) evaluation were considered PSGA responders."|Weeks 4, 8, 12, 24, 36, and 48||||percentage of participants|||Number
2603239|NCT02134210|Secondary|Change in PSGA (Physician's Static Global Assessment) of Disease Activity on a Scale of 0 to 5|"Change in PSGA (Physician's Static Global Assessment) of disease activity on a scale of 0 to 5 from baseline to Weeks 4, 8, 12, 24, 36, and 48.~Minimum Value: 0 Maximum Value: 5~The PSGA of PsO (Psoriasis) was assessed on a scale of 0 to 5, with 0 indicating no PsO (clear of disease),1 (almost clear), and 2 or higher scores indicating more severe disease. Subjects with a clear (0) or almost clear (1) evaluation were considered PSGA responders."|4, 8, 12, 24, 36, and 48||||score on a scale||Standard Deviation|Mean
2603240|NCT02134210|Secondary|Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)|The proportion of subjects who achieved a 50% improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% improvement in PASI (PASI-90) response rates from baseline at Weeks 4, 8, 12, 24, 36, and 48|Weeks 4, 8, 12, 24, 36, and 48||||participants|||Number
2603241|NCT02134210|Secondary|Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index)|The proportion of subjects who achieved PASI-75 (75% Improvement in Psoriasis Area and Severity Index) from baseline at Weeks 4, 8, 12, 24, 36, and 48.|Weeks 4, 8, 12, 24, 36, and 48||||Participants|||Count of Participants
2603242|NCT02134210|Secondary|Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline|Mean percent change in PASI from baseline at Weeks 4, 8, 12, 24, 36, and 48|Weeks 4, 8, 12, 24, 36, and 48|Part 2 of the study took place from week 13-48 and not all subjects that started the study were included in analysis|||percentage of change||Standard Deviation|Mean
2603243|NCT02134210|Primary|Mean Percent Change in PASI (Psoriasis Area and Severity Index) at 12 Weeks|Mean percent changed in PASI from baseline (last non-missing value prior to first dose) at Week 12. This was the primary endpoint supporting the Marketing Authorization Application in the EU.|12 Weeks||||percentage of change||Standard Deviation|Mean
2603244|NCT02134210|Primary|Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12|"The Psoriasis Area and Severity Index (PASI) is well established in the medical literature and is internationally the most widely used instrument to assess the severity of Psoriasis.~Proportion of subjects achieving PASI-75 from baseline at Week 12. This was the primary endpoint supporting a Biologics Licensing Application in the US."|12-weeks||||participants|||Number
2603245|NCT02134184|Other Pre-specified|To Compare the T- and B-cell Response to Licensed IM TIV in Elderly Individuals Dependent on the Presence and Duration of CMV Infection by Analyses of Vaccine-induced Plasmablasts, Antibodies and Antigen-specific T Cells||Day 0 to Day 28|||||||
2603246|NCT02134184|Secondary|Number of Participants With Related Adverse Events||Day 0 to Day 28||||Participants|||Count of Participants
2603247|NCT02134184|Primary|Number of Participants From Each Arm Who Received Influenza Vaccine||Day 0 to Day 28||||Participants|||Count of Participants
2603248|NCT02134119|Secondary|Hematological Measures - Hemoglobin|as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|35 days||||g/dL||Standard Deviation|Mean
2603249|NCT02134119|Secondary|Hematological Measures - Hemoglobin|as measured by hemoglobin (Hb) at day 0 (baseline), day 14 (mid-intervention) and day 35 (post-intervention)|14 days (mid-intervention)||||g/dL||Standard Deviation|Mean
2603263|NCT02134119|Primary|VO2 Max|A maximal graded exercise test on a treadmill (TrackMaster, TMX 425, Newton, KS) was used to determine VO2max using the modified Balke protocol. During the treadmill test, expired O2 and CO2 were continually measured using an open circuit metabolic measurement system (MedGraphics Ultima, CardioO2, St. Paul, MN). Participants performed a 5-minute warm-up on a treadmill at 0% grade. After the warm-up, the treadmill speed was then increased until participants were at 75% of their age-predicted maximal heart rate. Once this steady-state HR was achieved, the speed was kept constant while the grade increased by 2.5% every two minutes until volitional exhaustion. Criteria for ensuring that participants achieved VO2max in this study were achieving at least two of the following objective criteria: obtaining at least 90% of age-predicted max HR, a respiratory exchange ratio above 1.05, and/or a plateau in the VO2 response to exercise.|35-days||||ml/kg/min||Standard Deviation|Mean
2603264|NCT02134119|Primary|VO2 Max|A maximal graded exercise test on a treadmill (TrackMaster, TMX 425, Newton, KS) was used to determine VO2max using the modified Balke protocol. During the treadmill test, expired O2 and CO2 were continually measured using an open circuit metabolic measurement system (MedGraphics Ultima, CardioO2, St. Paul, MN). Participants performed a 5-minute warm-up on a treadmill at 0% grade. After the warm-up, the treadmill speed was then increased until participants were at 75% of their age-predicted maximal heart rate. Once this steady-state HR was achieved, the speed was kept constant while the grade increased by 2.5% every two minutes until volitional exhaustion. Criteria for ensuring that participants achieved VO2max in this study were achieving at least two of the following objective criteria: obtaining at least 90% of age-predicted max HR, a respiratory exchange ratio above 1.05, and/or a plateau in the VO2 response to exercise.|0-days (baseline)||||ml/kg/min||Standard Deviation|Mean
2603265|NCT02134015|Secondary|Part A: Objective Response Rate (ORR) in HRG Low Participants|"Key secondary efficacy endpoint: Objective response is defined as percentage of participants achieving complete response or partial response~Denominator for percentages is the number of subjects with measurable disease in the full analysis set. The best overall response is the best response (in the order of CR, PR, SD, and PD) among all overall responses recorded from the start of treatment until the subject withdraws from the study. If there is no post-baseline tumor assessment or all post-baseline tumor assessments with overall response being Inevaluable captured in the CRF, the best overall response is classified as Inevaluable."|by trial termination (at 20 months)|Evaluable participants in the full analysis set|||Participants|||Count of Participants
2603266|NCT02134015|Secondary|Part A: Objective Response Rate (ORR) in HRG High Participants|"Key secondary efficacy endpoint: Objective response is defined as percentage of participants achieving complete response (CR) or partial response (PR)~Denominator for percentages is the number of subjects with measurable disease in the full analysis set. The best overall response is the best response [in the order of CR, PR, stable disease (SD), and progressive disease (PD)] among all overall responses recorded from the start of treatment until the subject withdraws from the study. If there is no post-baseline tumor assessment or all post-baseline tumor assessments with overall response being Inevaluable captured in the CRF, the best overall response is classified as Inevaluable."|by trial termination (at 20 months)|Evaluable participants in the full analysis set|||Participants|||Count of Participants
2603267|NCT02134015|Secondary|Part B: Key Secondary Efficacy Endpoint: PFS, TTD|PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (TTD, as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause.|4 years|No participants were analyzed for Part B endpoints because the trial was terminated at the end of Part A.||||||
2603268|NCT02134015|Secondary|Part A: Key Secondary Efficacy Endpoint: Overall Survival in HRG Low Participants|Key secondary efficacy endpoint: Percentage of participants who survived for the length of the trial|by trial termination (at 20 months)||||Participants|||Count of Participants
2603269|NCT02134015|Secondary|Part A: Overall Survival in HRG High Participants|Key secondary efficacy endpoint: Percentage of participants who survived for the length of the trial|by trial termination (at 20 months)||||Participants|||Count of Participants
2603270|NCT02134015|Primary|Part B: Overall Survival|Percentage of participants still alive at the end of Part B|4 years|No participants were analyzed for Part B endpoints because the trial was terminated at the end of Part A.||||||
2603271|NCT02134015|Primary|Part A: Progression Free Survival (PFS) in Heregulin-low Participants|"PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause.~Kaplan-Meier Estimate. Confidence interval (CI) for median was computed using the Brookmeyer-Crowley method. 80% confidence interval is included in the data table."|by trial termination (at 20 months)||||months||80% Confidence Interval|Number
2603272|NCT02134015|Primary|Part A: Progression Free Survival (PFS) in Heregulin-high Participants|"PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause.~Kaplan-Meier Estimate. Confidence interval (CI) for median was computed using the Brookmeyer-Crowley method. 80% confidence interval is included in the data table."|by trial termination (at 20 months)||||months||80% Confidence Interval|Number
2603273|NCT02133781|Other Pre-specified|To Investigate the Effects of Age and Vaccine Type on B-cell Responses to Influenza Vaccine||Day 0 to 28|||||||
2603274|NCT02133781|Secondary|Number of Participants With Related Adverse Events||Day 0 to 28 post-immunization||||Participants|||Count of Participants
2603275|NCT02133781|Primary|Number of Participants From Each Arm Who Received Influenza Vaccine||Day 0 to 28||||Participants|||Count of Participants
2603276|NCT02133742|Secondary|Change From Baseline in Vascular Endothelial Growth Factor A (VEGF-A), Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) and Interleukin 8 (IL-8) in Serum at Cycle 43 Day 21||Baseline, Cycle 2 Day 1: Predose and end of treatment or withdrawal (up to Cycle 43)|||||||
2603277|NCT02133742|Secondary|Number of Participants With Vascular Endothelial Growth Factor A (VEGF-A) Tumor Proportion Score||Baseline up to Cycle 43 (up to 1083 days)|||||||
2603322|NCT02133066|Secondary|Percentage of Overall Success of Lumbar Punctures in the Ultrasound-assisted Group Versus the Non-ultrasound-assisted Group|Overall success of lumbar punctures (within 3 attempts) in the non-ultrasound-assisted group compared to the ultrasound-assisted group|30 minutes||||percentage success||95% Confidence Interval|Number
2603278|NCT02133742|Secondary|Number of Participants With Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score|PD-L1- tumor proportion score was defined as the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. Participants with positive or negative scores were reported. PD-L1 negative: if tumor proportion score was less than 1%; PD-L1 positive: if the tumor proportion score greater than or equal to 1%.|Baseline up to Cycle 43 (up to 1083 days)|"Tumor biomarker analysis set included all treated participants who had at least one screening biomarker assessment, and had received at least one dose of any study drug. Here, N signifies number of participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2603279|NCT02133742|Secondary|Number of Participants With Positive Anti-Drug Antibodies (ADA) of Pembrolizumab (MK-3475)||Day 1 of Cycle 1, 3, 5, 11 and every 12 weeks afterwards up to maximum of 43 weeks (up to 1083 days)|||||||
2603280|NCT02133742|Secondary|Apparent Volume of Distribution (Vz/F) of Axitinib and Pembrolizumab (MK-3475)||Pre dose, 1, 2, 3, 4, 6, 8 hours post dose|||||||
2603281|NCT02133742|Secondary|Apparent Oral Clearance (CL/F) of Axitinib and Pembrolizumab (MK-3475)||Pre dose, 1, 2, 3, 4, 6, 8 hours post dose|||||||
2603282|NCT02133742|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC 0-12) of Axitinib and Pembrolizumab (MK-3475)||Pre dose, 1, 2, 3, 4, 6, 8 hours post dose|||||||
2603283|NCT02133742|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib and Pembrolizumab (MK-3475)||Pre dose, 1, 2, 3, 4, 6, 8 hours post dose|||||||
2603284|NCT02133742|Secondary|Maximum Observed Plasma Concentration (Cmax) of Axitinib and Pembrolizumab (MK-3475)||Pre dose, 1, 2, 3, 4, 6, 8 hours post dose|||||||
2603285|NCT02133742|Secondary|Overall Survival (OS)|OS was defined as the time from the first dose of study drug to the date of death due to any cause. For participants still alive at the time of analysis, the OS time was censored on the last date the participants were known to be alive.|Baseline until disease progression or death due to any cause, up to a maximum of 1083 days|Response evaluable analysis set included all participants who received study treatment with an adequate baseline tumor assessment (using standard RECIST version 1.1 criteria).|||months||95% Confidence Interval|Median
2603286|NCT02133742|Secondary|Progression-Free Survival (PFS)|PFS: time from date of first dose of study drug to the date of first documented PD or death on study due to any cause. PD as per RECIST v1.1 defined as at least a 20% increase in sum of longest dimensions of target lesions, reference to smallest sum of longest dimensions recorded since treatment started, or appearance of 1 or more new lesions or increase of at least 5 mm in addition to relative increase of 20%. Participants lacking an evaluation of tumor response after date of first study drug dose had event time censored on date of first dose unless death occurred prior to 18 weeks. If participants had at least 1 on-study assessment, PFS data was censored on date of last evaluable tumor disease assessment documenting absence of PD for participants who were alive and progression free at the time of analysis or had documentation of PD or had death after >=2 consecutive missed tumor assessments or were given anti-tumor treatment other than study drug prior to documented PD or death.|Baseline until disease progression or death due to any cause, up to a maximum of 1083 days|Response evaluable analysis set included all participants who received study treatment with an adequate baseline tumor assessment (using standard RECIST version 1.1 criteria).|||months||95% Confidence Interval|Median
2603287|NCT02133742|Secondary|Time to Response (TTR)|TTR was defined as the time from first dose of study treatment to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed.|Baseline until disease progression or death due to any cause, up to a maximum of 1083 days|"Response evaluable analysis set included all participants who received study treatment with an adequate baseline tumor assessment (using standard RECIST version 1.1 criteria). Here, N signifies number of participants who were evaluable for this outcome measure."|||months||Full Range|Median
2603288|NCT02133742|Secondary|Duration of Response (DR)|DR:date of first documentation of objective tumour response(OR) confirmed to date of first documentation of PD/death due to any cause,whichever occurred first.PD per RECIST 1.1:>=20%increase in sum of longest dimensions(LD) of target lesions,reference to smallest sum of LD recorded since treatment started/appearance of 1 or more new lesions/increase of at least 5mm addition to relative increase of 20%.DR calculated only for participants with confirmed OR.Participants lacking evaluation of tumour response after date of first study drug dose was censored on date of first dose unless death occurred prior to 18 weeks.If participants had at least 1 on-study assessment,PFS was censored on date of last evaluable tumour disease assessment documenting absence of PD for participants who were alive and progression free at time of analysis/had documentation of PD/death after>=2 consecutive missed tumour assessments/given anti-tumour treatment other than study drug prior to documented PD/death.|Baseline until disease progression or death due to any cause, up to a maximum of 1083 days|"Response evaluable analysis set included all participants who received study treatment with an adequate baseline tumor assessment (using standard RECIST version 1.1 criteria). Here, N signifies number of participants who were evaluable for this outcome measure."|||months||95% Confidence Interval|Median
2603289|NCT02133742|Secondary|Objective Response Rate|Objective response rate was defined as percentage of participants with confirmed complete response (CR) or confirmed partial response (PR), as assessed by response evaluation criteria in solid tumors (RECIST) version 1.1. Confirmed responses were those that persist on repeated imaging for at least 4 weeks after initial documentation of response. CR was defined as disappearance of all target lesions and the reduction in short axis of any pathological lymph nodes to <10 mm. PR was defined as a 30% or more decrease in the sum of longest dimensions of the target lesions, taking as reference the baseline sum of longest dimensions.|Baseline until disease progression or death due to any cause, up to a maximum of 1083 days|Response evaluable analysis set included all participants who received study treatment with an adequate baseline tumor assessment (using standard RECIST version 1.1 criteria).|||percentage of participants||95% Confidence Interval|Number
2603323|NCT02133066|Primary|Percentage of Successful First Attempt Lumbar Punctures in the Ultrasound-assisted Group as Compared to the Non-ultrasound Assisted Group|First attempt success in ultrasound-assisted group compared to first attempt success in non-ultrasound assisted group|30 minutes||||percent success||95% Confidence Interval|Number
2603473|NCT02131532|Secondary|Stroke Impact Scale (SIS) - General Rating of Recovery|The general rating scale on the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes of recovery.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
2603290|NCT02133742|Secondary|Number of Participants With Eastern Cooperative Oncology Group [ECOG] Performance Status Score|ECOG performance status was used to assess how disease affect the daily living abilities of a participant. It was measured on a scale ranging from 0 to 4, where 0=fully active (able to carry on all pre-disease activities without restriction); 1=restricted in physically strenuous activity but ambulatory (able to carry out light/sedentary work); 2=ambulatory and capable of all self-care but unable to carry out any work activities (for more than 50% of waking hours); 3=capable of limited self-care, confined to bed or chair (for >50% of waking hours); 4=completely disabled, not capable of any self-care, totally confined to bed or chair. Higher scores signified =more functional impairment of a participant.|Baseline up to Cycle 43 (up to 1083 days)|Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or pembrolizumab.|||Participants|||Count of Participants
2603291|NCT02133742|Secondary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included blood pressure, pulse rate and weight. Change from baseline values were considered to be clinically significant based on investigator's judgement.|Baseline up to end of treatment (maximum of 1083 days)|Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or pembrolizumab.|||Participants|||Count of Participants
2603292|NCT02133742|Secondary|Number of Participants With Laboratory Test Abnormalities: Urinalysis|Urinalysis parameter included urine protein, urine blood/hemoglobin and urine glucose. Test abnormalities was defined as deviation from normal range. Normal range of 24-hour urine protein test: less than 150 mg of protein per day, urine glucose: 0 to 0.8 mmol/L (millimoles per liter), urine protein: 0 to 20 mg/dL (milligrams per deciliter). Urine blood/hemoglobin abnormality was defined as presence and absence of blood/hemoglobin in urine of participants.|Baseline up to end of treatment (maximum of 1083 days)|Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or pembrolizumab.|||Participants|||Count of Participants
2603293|NCT02133742|Secondary|Number of Participants With Laboratory Test Abnormalities of Grade 3 or Higher Severity Based on NCI CTCAE Version 4.03: Biochemistry and Hematology|Laboratory parameters included hematological and biochemistry parameters. Biochemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin (total), creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia. Hematology parameters included anemia, haemoglobin increased, lymphocyte count increased, lymphopenia, neutrophils (absolute), platelets and white blood cells. Test abnormalities were graded by NCI CTCAE version 4.03 as Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Only categories with at least 1 participant with abnormality are reported in this outcome measure.|Baseline up to end of treatment (maximum of 1083 days)|Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or pembrolizumab.|||Participants|||Count of Participants
2603294|NCT02133742|Secondary|Number of Participants With Adverse Events (AEs) According to Severity of Grade 3 or Higher Severity Based on NCI CTCAE Version 4.03|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were graded according to the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and coded using the Medical Dictionary for Regulatory Activities (MedDRA) as Grade 3: Severe, Grade 4: Life threatening, Grade 5: Death related to AE. Participants were counted once according to the maximum grade observed.|Baseline, up to 28 days after last dose of study drug (up to 1111 days)|Safety analysis set included all enrolled participants who received at least one dose of axitinib or pembrolizumab.|||Participants|||Count of Participants
2603295|NCT02133742|Secondary|Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline, up to 28 days after last dose of study drug (up to 1111 days)|Safety analysis set included all enrolled participants who received at least one dose of axitinib or pembrolizumab.|||Participants|||Count of Participants
2603296|NCT02133742|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline, up to 28 days after last dose of study drug (up to 1111 days)|Safety analysis set included all enrolled participants who received at least one dose of axitinib or pembrolizumab.|||Participants|||Count of Participants
2603359|NCT02132936|Secondary|Subjects With PASI 75 at Week 4 for LEO 90100 and at Week 8 for Calcipotriol BDP Gel.|Subjects with PASI 75 (a 75% reduction in the modified Psoriasis Area and Severity Index) at Week 4 for LEO 90100 and at Week 8 for calcipotriol BDP gel.|Week 4 for LEO 90100; Week 8 for calcipotriol BDP gel||||percentage of subjects|||Number
2603361|NCT02132910|Other Pre-specified|Symptom Burden|Symptom burden was assessed using the PROMIS-29 Sleep Disturbance, Pain Interference, Anxiety, Depression, and Fatigue subscales (0-100) Subscales are averaged into a composite score.The Composite scale ranges from 0 to 100, with higher scores indicating higher symptom burden.|Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up||||units on a scale||Standard Deviation|Mean
2603297|NCT02133742|Primary|Number of Participants With Dose-Limiting Toxicities (DLT): Dose Finding Phase|DLT was defined as any of the following adverse events (AEs) occurring in the first two cycles of treatment which were attributable to one or both the study drugs: 1) Grade 4 neutropenia, 2) Febrile neutropenia lasting greater than (>) 1 hour, 3) Grade greater than or equal to (>=) 3 neutropenia with infection, 4) Grade >=3 thrombocytopenia with bleeding, 4) Grade 4 thrombocytopenia, 5) Any grade >=3 non-hematologic: non-laboratory toxicities despite maximum supportive therapy or hypertension despite maximal medical therapy, 6) Grade >=3 non-hematologic toxicities resulted in hospitalisation or medical intervention 7) Inability to complete at least 75 percent (%) of axitinib dosing or 2 infusions of pembrolizumab within the DLT observation period (up to 42 days) due to treatment related toxicity. Severity of AEs was graded according to NCI (National Cancer Institute) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.|Cycle 1 Day 1 to Cycle 2 Day 21 (up to 42 days)|Per protocol analysis set included all enrolled eligible participants who received at least 1 dose of axitinib or pembrolizumab and experienced DLT during first 2 cycles, or complete the observation period for first 2 cycles of treatment. Here, number of participant analyzed (N) = number of participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2603298|NCT02133664|Primary|Controlled Oral Word Association Test (COWAT)|The COWAT is a letter fluency test. Participants are asked to generate as many words as possible beginning with a particular letter of the alphabet during one minute. Alternate versions using 3 letters are used for each examination. The change in total number of words produced for the 3 letters from baseline to 12 weeks will be the outcome.|baseline to 12 weeks|Only participant who completed COWAT at both baseline and 12 weeks were analyzed|||words||Standard Deviation|Mean
2603299|NCT02133664|Primary|California Verbal Learning Test-II (CVLT-II)|"CVLT-II is a measure of verbal learning/memory. It is comprised of lists containing 16 words, each of which fit into one of four categories of shopping list items. Five trials are administered followed by presentation of a different list. Free and cued recall of the original list is assessed. The change in long delay free recall from baseline to 12 weeks will be the measurement used for outcome."|baseline to 12 weeks|Only participants who completed CVLT-II at baseline and 12 weeks were analyzed|||correct responses||Standard Deviation|Mean
2603300|NCT02133664|Primary|Stroop Color-Word Test|"The Stroop test assess attention and executive function.The task consists of 3 tasks with only red, green, and blue colors used. The first task asks the subject to name the colors of spots on cards. If a subject can perform this task the second task is performed in which a subject must read the names of colors listed on cards (which are printed in congruent colors). In the third task, the subject is shown a series of words naming colors but the words and colors are mismatched; so the word yellow may be red, the word blue may be green and so forth. The subject is instructed to ignore the word and name the color. The subject will have the tendency to read the word rather than name the color, the so-called Stroop effect. This third part of the test is referred to as the interference condition and is the critical measurement. The change in time it takes to complete the interference from baseline to 12 weeks is the outcome measure."|baseline to 12 weeks|Analysis occurs only for participants who completed Stroop at both baseline and 12 weeks|||seconds||Standard Deviation|Mean
2603301|NCT02133664|Primary|Paced Auditory Serial Addition Task (PASAT)|The PASAT is a measure of working memory and sustained attention frequently used in multiple sclerosis treatment outcome studies. The examinee is presented with a series of numbers at 2 second intervals on an audiotape and responds by always adding the last two numbers on the tape before the next number is presented. The change in total number of correct responses from baseline to 12 weeks is the measurement for the outcome.|Baseline to 12 weeks|Only participants who completed PASAT at both baseline and 12 weeks were analyzed.|||correct responses||Standard Deviation|Mean
2603302|NCT02133534|Primary|Improved Counts of Endothelial Progenitor Cells|Improvement of endothelial cell (EC) dysfunction will be assessed by improved counts of endothelial progenitor cells.|baseline, 30 days|Early termination because of insufficient accrual. With only one study participant, data could not be analyzed.||||||
2603303|NCT02133508|Secondary|Percentage of Participants With Adverse Events (AEs)|An AE is an unfavorable and unintended sign, symptom, or disease temporally associated with a clinical study, regardless of causality.|Up to 8 months|All eligible participants|||percentage of participants|||Number
2603304|NCT02133508|Secondary|Overall Survival|Overall survival was defined as the time from the beginning of therapy with erlotinib to death from any cause.|Up to 8 months|All eligible participants|||months||95% Confidence Interval|Median
2603305|NCT02133508|Secondary|Progression-free Survival (PFS) According to RECIST v1.1|PFS was defined as the time from the beginning of therapy with erlotinib to the first occurrence of disease progression, as determined by the investigator using RECIST v1.1 criteria, or death from any cause. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Up to 8 months|All eligible participants|||days||95% Confidence Interval|Median
2603306|NCT02133508|Primary|Duration of SD or Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|The duration of SD or objective response (CR+PR) was defined as the time from first occurrence of SD or objective response to the time of PD, or death for any cause. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 mm in short axis. PR was defined as at least 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Up to 8 months|All eligible participants|||percentage of participants|||Number
2603362|NCT02132910|Other Pre-specified|Physical Functioning|Physical functioning was assessed using the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Physical Functioning subscale (0-100) Total scores are transformed to standardized t scores (mean=50; SD=10). Higher scores indicate higher physical functioning.|Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up||||units on a scale||Standard Deviation|Mean
2603307|NCT02133508|Primary|Percentage of Participants With Stable Disease (SD) or Objective Response (Complete and Partial Response [CR + PR] According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Objective response was defined as having a CR or PR. CR was defined as disappearance of all target and non-target lesions and no new lesions, and all pathological lymph nodes must have decreased to <10 millimeters (mm) in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and an absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Up to 8 months|All eligible participants|||percentage of participants|||Number
2603308|NCT02133352|Secondary|Change in BNP Cardiac Biomarker|"Assess the change from baseline in BNP cardiac biomarkers after 180 days of twice daily ranolazine.~Cardiac biomarkers may be completed at optional follow up visit for patients continuing on ranolazine following completion of the 180 day treatment period."|180 days||||pg/mL||Standard Deviation|Mean
2603309|NCT02133352|Secondary|Change in Echocardiogram Parameters (LVEF)|"To assess the changes from baseline in echocardiographic parameters (left ventricular geometry and function, LVEF, evidence of diastolic dysfunction, SPAP, right ventricular geometry and function, degree of tricuspid regurgitation) after 180 days of twice daily ranolazine.~An additional echo may be completed at optional follow up visit for patients continuing on ranolazine following completion of the 180 day treatment period."|180 days||||LVEF %||Standard Deviation|Mean
2603310|NCT02133352|Secondary|Change in Cardiac Size and Function|"Assess changes from baseline in measurements of cardiac size and function obtained by MRI after 180 days of twice daily ranolazine.~An additional MRI may be completed at optional follow up visit for patients continuing on ranolazine following completion of the 180 day treatment period."|180 days||||% ejection fraction||Standard Deviation|Mean
2603311|NCT02133352|Secondary|6 Minute Walk Test (6MWT)|Assess the change from baseline in 6 minute walk test (6MWT) after 180 days of twice daily ranolazine Optional follow up for some patients also includes 6MWT.|180 days||||meters||Standard Deviation|Mean
2603312|NCT02133352|Secondary|Percent Change in Other Hemodynamic Parameters|"Assess % change in other hemodynamic parameters, by RHC, from baseline afeter 180 days of ranolazine.~Right atrial pressure (RAP) Systolic pulmonary artery pressure (SPAP) Diastolic pulmonary artery pressure (DPAP) Cardiac output (CO) Cardiac index (CI)"|180 days||||percent change||Standard Deviation|Mean
2603313|NCT02133352|Primary|Percent Change in mPAP, PAOP and Pulmonary Vascular Resistance (PVR)|"Assess the percent change in mPAP, PAOP and pulmonary vascular resistance (PVR) by RHC.~Additional RHC completed at optional follow up for patients remaining on ranolazine upon completion of 180 day period."|180 days|We hypothesize that patients with pulmonary hypertension associated with diastolic left ventricular dysfunction treated with Ranolazine (initiated at 500 mg twice daily and increased to 1000mg twice daily) would have improved hemodynamic parameters, functional capacity and exercise tolerance compared to baseline.|||percentage change||Standard Deviation|Mean
2603314|NCT02133235|Primary|Time Required for Proper Placement of the Endobronchial Blocker||10-15 minutes||||seconds||Standard Deviation|Mean
2603315|NCT02133235|Primary|Surgical Grading for Lung Isolation|A: Optimal; B: Lung distension; C: Poor endobronchial blocker placement|10-15 minutes||||participants|||Number
2603316|NCT02133131|Secondary|Percentage of Participants Achieving SVR 4 Weeks After Completing All Study Therapy (SVR4)|The percentage of participants achieving SVR4, defined as HCV ribonucleic acid (RNA) <15 IU/mL 4 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.|Up to 16 weeks|Analysis of SVR4 is ongoing and results will be indicated in a future report.||||||
2603317|NCT02133131|Primary|Number of Participants Discontinuing Study Therapy Due to an AE|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 12|The APaT population consists of all participants who received ≥1 dose of study drug.|||Number of participants|||Number
2603318|NCT02133131|Primary|Number of Participants Experiencing at Least 1 Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 14|The All Participants as Treated (APaT) population consists of all participants who received ≥1 dose of study drug.|||Number of participants|||Number
2603319|NCT02133131|Primary|Percentage of Participants With Sustained Viral Response (SVR) 12 Weeks After Completing All Study Therapy (SVR12)|The percentage of participants achieving SVR12, defined as HCV ribonucleic acid (RNA) <15 IU/mL 12 weeks after completing all study therapy, was determined for each arm. Plasma levels of HCV RNA were measured using the Roche COBAS© AmpliPrep/COBAS© TaqMan© HCV Test v. 2.0.|Up to 24 weeks|The Per Protocol (PP) population includes all randomized and treated participants who did not have protocol deviations that may substantially affect the results of the primary and secondary endpoints.|||Percentage of participants||95% Confidence Interval|Number
2603320|NCT02133066|Secondary|Length of Antibiotic Use in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients|If a lumbar puncture is not successful, this may lead to unnecessary (prophylactic) antibiotic use until a lumbar puncture can be completed (with interventional radiology or other resources) to rule out meningitis. According to our hypothesis, we believe that ultrasound assistance will increase the proportion of successful lumbar punctures, and therefore, decrease the length of unnecessary antibiotics.|Participants will be followed until discontinuation of antibiotics, an expected average of 2 days||||hours||95% Confidence Interval|Median
2603321|NCT02133066|Secondary|Length of Hospitalization in Ultrasound-assisted Lumbar Puncture Patients Versus Non-ultrasound-assisted Patients|If a lumbar puncture is not successful, this may lead to a longer hospitalization than necessary until a lumbar puncture can be completed (with interventional radiology or other resources). According to our hypothesis, we believe that ultrasound assistance will increase the proportion of successful lumbar punctures, and therefore, decrease the length of unnecessary hospitalization.|Participants will be followed for the duration of the hospital stay, an expected average of 2 days||||hours||95% Confidence Interval|Median
2603324|NCT02133001|Secondary|Change From Baseline to Double-blind Phase-Endpoint (Day 25) in Beck Hopelessness Scale Total Score (Double-blind Phase)|"BHS is paper-based self-reported measure to assess one's level of negative expectations or pessimism regarding future. Consists of 20 true-false items that examine the respondent's attitude over past week by either endorsing a pessimistic statement or denying an optimistic statement; 9 are keyed false and 11 are keyed true. Items fall within 3 domains: feelings about future; loss of motivation; future expectations. each response is assigned a score of 0 or 1. Total BHS score is sum of item responses, with range from 0 to 20, with a higher score representing higher level of hopelessness. Total scores that range from 0 to 3 are (normal range), scores 4 to 8 (mild hopelessness, scores 9 to 14 (moderate hopelessness), scores <14 (severe hopelessness). Negative change in score indicates improvement. The LOCF approach was used for missing visit data in the ITT LOCF efficacy analyses. The last post baseline observation was carried forward as the End Point for the double-blind phase."|Baseline (Day 1-predose) to Double-blind Phase-Endpoint (Day 25)|ITT analysis set: all randomized participants who received at least 1 dose of study medication during the double-blind phase and have both the baseline and the Day 1-4 hour post dose evaluation for the MADRS total score. Here 'N' signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2603325|NCT02133001|Secondary|Change From Baseline to Day 1: 4-Hours Postdose in Beck Hopelessness Scale (BHS) Total Score (Double-blind Phase)|BHS is paper-based self-reported measure to assess one's level of negative expectations or pessimism regarding future. Consists of 20 true-false items that examine the respondent's attitude over past week by either endorsing a pessimistic statement or denying an optimistic statement; 9 are keyed false and 11 are keyed true. Items fall within 3 domains: feelings about future; loss of motivation; future expectations. each response is assigned a score of 0 or 1. Total BHS score is sum of item responses, with range from 0 to 20, with a higher score representing higher level of hopelessness. Total scores that range from 0 to 3 are (normal range), scores 4 to 8 (mild hopelessness, scores 9 to 14 (moderate hopelessness), scores <14 (severe hopelessness). Negative change in score indicates improvement. The LOCF approach was used for missing visit data in the ITT LOCF efficacy analyses.|Baseline (Day 1-predose) to Day 1: 4-hours Postdose|ITT analysis set: all randomized participants who received at least 1 dose of study medication during the double-blind phase and have both the baseline and the Day 1, 4-hour post dose evaluation for the MADRS total score. Here 'N' signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2603326|NCT02133001|Secondary|Change From Baseline to Follow-up Phase-Endpoint (Day 81) in Beck Scale for Suicidal Ideation Total Score (Follow-up Phase)|"BSS is 21-item self-reported instrument to detect and measure severity of suicidal ideation. BSS measures broad spectrum of attitudes and behaviors associated with risk of suicide. Items in scale assess respondent's suicidal plans, deterrents to suicide, level of openness to revealing suicidal thoughts. First 19 items of scale measure gradations of severity of suicidal wishes, attitude, plans.Statements reflect increasing gradations of this severity,are scored from 0 to 2. Final two items ask about number of suicide attempts, seriousness of intention to die associated with last attempt,they are not used in calculating BSS total score. Total BSS score represents severity of suicide ideation, calculated by summing ratings of first 19 items;total score ranges from 0 to 38, with higher score representing greater suicide ideation. LOCF approach used for missing visit data in ITT LOCF efficacy analyses, last post baseline observation was carried forward as the End Point follow up phase."|Baseline (Day 1-predose) to Follow-up Phase-Endpoint (Day 81)|The ITT (Follow Up phase) analysis set was defined as all participants who had at least one measurement of MADRS total score during the follow up phase. Here 'N' signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2603327|NCT02133001|Secondary|Change From Baseline to Double-blind Phase-Endpoint (Day 25) in Beck Scale for Suicidal Ideation Total Score (Double-blind Phase)|"BSS is 21-item self-reported instrument to detect and measure severity of suicidal ideation.BSS measures broad spectrum of attitudes and behaviors associated with risk of suicide. Items in scale assess respondent's suicidal plans, deterrents to suicide, level of openness to revealing suicidal thoughts. First 19 items of scale measure gradations of severity of suicidal wishes, attitude, plans.Statements reflect increasing gradations of this severity,are scored from 0 to 2. Final two items ask about number of suicide attempts, seriousness of intention to die associated with last attempt,they are not used in calculating BSS total score. Total BSS score represents severity of suicide ideation, calculated by summing ratings of first 19 items;total score ranges from 0 to 38, with higher score representing greater suicide ideation. LOCF approach used for missing visit data in ITT LOCF efficacy analyses. Last post baseline observation was carried forward as End Point for double-blind phase."|Baseline (Day 1-predose) to Double-blind Phase-endpoint (Day 25)|ITT analysis set: all randomized participants who received at least 1 dose of study medication during the double-blind phase and have both the baseline and the Day 1, 4-hour post dose evaluation for the MADRS total score. Here 'N' signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2603328|NCT02133001|Secondary|Change From Baseline to Day 2 in Beck Scale for Suicidal Ideation (BSS) Total Score (Double-blind Phase)|BSS is 21-item self-reported instrument to detect and measure severity of suicidal ideation. BSS measures broad spectrum of attitudes and behaviors associated with risk of suicide. Items in scale assess respondent's suicidal plans, deterrents to suicide,level of openness to revealing suicidal thoughts. First 19 items of scale measure gradations of severity of suicidal wishes, attitude, plans.Statements reflect increasing gradations of this severity,are scored from 0 to 2. Final two items ask about number of suicide attempts, seriousness of intention to die associated with last attempt,they are not used in calculating BSS total score. Total BSS score represents severity of suicide ideation, calculated by summing ratings of first 19 items;total score ranges from 0 to 38, with higher score representing greater suicide ideation. LOCF approach used for missing visit data in ITT LOCF efficacy analyses.|Baseline (Day 1-predose) to Day 2|ITT analysis set: all randomized participants who received at least 1 dose of study medication during the double-blind phase and have both the baseline and the Day 1, 4-hour post dose evaluation for the MADRS total score. Here 'N' signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2603453|NCT02131662|Secondary|Change in Volume of Menstrual Blood Loss Per 28 Days From Baseline During Treatment by Reference Period (Assessed by Alkaline Hematin Method)|"In the below table, N signifies subjects who were evaluable for the specific parameter at that timepoint for each arm, respectively."|From baseline to end of follow-up||||mL||Standard Deviation|Mean
2603329|NCT02133001|Secondary|Change From Baseline to Day 1: 4-Hours Postdose in Beck Scale for Suicidal Ideation (BSS) Total Score (Double-blind Phase)|BSS is 21-item self-reported instrument to detect and measure severity of suicidal ideation. BSS measures broad spectrum of attitudes and behaviors associated with risk of suicide. Items in scale assess respondent's suicidal plans, deterrents to suicide, level of openness to revealing suicidal thoughts. First 19 items of scale measure gradations of severity of suicidal wishes,attitude, plans.Statements reflect increasing gradations of this severity,are scored from 0 to 2. Final two items ask about number of suicide attempts, seriousness of intention to die associated with last attempt,they are not used in calculating BSS total score. Total BSS score represents severity of suicide ideation, calculated by summing ratings of first 19 items;total score ranges from 0 to 38, with higher score representing greater suicide ideation. LOCF approach used for missing visit data in ITT LOCF efficacy analyses.|Baseline (Day 1-predose) to Day 1: 4-hours postdose|ITT analysis set: all randomized participants who received at least 1 dose of study medication during the double-blind phase and have both the baseline and the Day 1-4 hour post dose evaluation for the MADRS total score. Here 'N' signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2603330|NCT02133001|Secondary|Change From Baseline to Follow-up Phase-Endpoint (Day 81) in Suicide Ideation and Behavior Assessment Tool Patient-Reported Global Assessment of Suicide Risk (Module 6) Score (Follow-up Phase)|"SIBAT was specifically developed to measure rapid change in suicidality, based on concerns that existing scales such as BSS are not designed to discriminate differences associated with rapid change. Patient-rated section includes following modules: Module 1 (M-1)(demographic information,suicide history), M-2(current suicidal thinking),M-3 (protective factors), M-4 (suicide behavior),M-5(suicide risk),M-6(suicide-implicit association test).Patient-reported global assessment of suicide risk summarizes patient's judgment of suicide risk (Module 6). Scores: 0(None), 1(Very weak), 2(Weak), 3(Moderately weak), 4(Mild), 5(Moderate), 6 (Moderately strong), 7(Strong), 8(Extremely strong), 9(Extremely strong,constant). Negative change in score indicates improvement. LOCF approach used for missing visit data in ITT LOCF efficacy analyses, last post baseline observation was carried forward as the End Point follow up phase."|Baseline (Day 1-predose) to Follow-up Phase Endpoint (Day 81)|The ITT (Follow Up phase) analysis set was defined as all participants who had at least one measurement of MADRS total score during the follow up phase.|||Units on a scale||Full Range|Median
2603331|NCT02133001|Secondary|Change From Baseline to Double Blind Phase-Endpoint (Day 25) in Suicide Ideation and Behavior Assessment Tool Patient-Reported Global Assessment of Suicide Risk (Module 6) Score (Double-blind Phase)|"SIBAT was specifically developed to measure rapid change in suicidality, based on concerns that existing scales such as BSS are not designed to discriminate differences associated with rapid change. Patient-rated section includes following modules: Module 1 (M-1)(demographic information,suicide history), M-2(current suicidal thinking),M-3 (protective factors), M-4 (suicide behavior),M-5(suicide risk),M-6(suicide-implicit association test).Patient-reported global assessment of suicide risk summarizes patient's judgment of suicide risk (Module 6). Scores: 0(None), 1(Very weak), 2(Weak), 3(Moderately weak), 4(Mild), 5(Moderate), 6 (Moderately strong), 7(Strong), 8(Extremely strong), 9(Extremely strong,constant). Negative change in score indicates improvement. LOCF approach used for missing visit data in the ITT LOCF efficacy analyses. Last post baseline observation was carried forward as End Point for double-blind phase."|Baseline (Day 1-predose) to Double-blind Phase-Endpoint (Day 25)|Intent-To-Treat Analysis (ITT) analysis set defined as all randomized participants who received at least 1 dose of study medication during the double-blind phase and had both the baseline and the Day 1-4 hour post dose evaluation for the MADRS total score.|||Units on a scale||Full Range|Mean
2603332|NCT02133001|Secondary|Change From Baseline to Day 2 in Suicide Ideation and Behavior Assessment Tool Patient-Reported Global Assessment of Suicide Risk (Module 6) Score (Double-blind Phase)|SIBAT was specifically developed to measure rapid change in suicidality, based on concerns that existing scales such as BSS are not designed to discriminate differences associated with rapid change. Patient-rated section includes following modules: Module 1 (M-1)(demographic information,suicide history), M-2(current suicidal thinking),M-3 (protective factors), M-4 (suicide behavior),M-5(suicide risk),M-6(suicide-implicit association test).Patient-reported global assessment of suicide risk summarizes patient's judgment of suicide risk (Module 6). Scores: 0(None), 1(Very weak), 2(Weak), 3(Moderately weak), 4(Mild), 5(Moderate), 6 (Moderately strong), 7(Strong), 8(Extremely strong), 9(Extremely strong,constant). Negative change in score indicates improvement. LOCF approach used for missing visit data in the ITT LOCF efficacy analyses.|Baseline (Day 1-predose) to Day 2|Intent-To-Treat Analysis (ITT) analysis set defined as all randomized participants who received at least 1 dose of study medication during the double-blind phase and have both the baseline and the Day 1-4 hour post dose evaluation for the MADRS total score.|||Units on a scale||Full Range|Median
2603333|NCT02133001|Secondary|Change From Baseline to Day 1: 4- Hours Postdose in SIBAT-Patient-Reported Global Assessment of Suicide Risk (Module 6) Score (Double-blind Phase)|SIBAT was specifically developed to measure rapid change in suicidality, based on concerns that existing scales such as Beck Scale for Suicidal Ideation (BSS) are not designed to discriminate differences associated with rapid change. Patient-rated section includes following modules: Module 1 (M-1)(demographic information,suicide history), M-2(current suicidal thinking),M-3 (protective factors), M-4 (suicide behavior),M-5(suicide risk),M-6(suicide-implicit association test).Patient-reported global assessment of suicide risk summarizes patient's judgment of suicide risk (Module 6). Scores: 0(None), 1(Very weak), 2(Weak), 3(Moderately weak), 4(Mild), 5(Moderate), 6 (Moderately strong), 7(Strong), 8(Extremely strong), 9(Extremely strong,constant). Negative change in score indicates improvement. LOCF approach used for missing visit data in the ITT LOCF efficacy analyses.|Baseline (Day 1-predose) to Day 1: 4-hours postdose|Intent-To-Treat Analysis (ITT) analysis set defined as all randomized participants who received at least 1 dose of study medication during the double-blind phase and had both the baseline and the Day 1-4 hour post dose evaluation for the MADRS total score.|||Units on scale||Full Range|Median
2603363|NCT02132910|Secondary|Disability|"The Roland Morris Disability Questionnaire is reliable at measuring level of disability and is sensitive to change over time for groups of patients with lower back pain.~Scale: 0-24 (24 total statements)~-Greater levels of disability are reflected by higher numbers on a 24-point scale See link for complete statements: https://www.worksafe.qld.gov.au/__data/assets/pdf_file/0009/76851/roland-morris-low-back-pain-and-disability-questionnaire-rmq1.pdf"|Baseline, Midtreatment, Posttreatment, 3 month follow up, 6 month follow up||||units on a scale||Standard Deviation|Mean
2603334|NCT02133001|Secondary|Change From Baseline to Follow-up Phase-Endpoint (Day 81) in Suicide Ideation and Behavior Assessment Tool (SIBAT)-Clinical Global Judgment of Suicide Risk Score (Follow-up Phase)|"SIBAT CGJ-SR: Module 8 operates like numerous other CGI severity scales used in other psychiatric studies. Changes in CGJ-SR designed to categorize clinically meaningful changes in clinician rated suicide risk from 'not at all suicidal' to 'participant is at imminent risk of suicide and immediate need for strong intervention (hospitalization with 24 hour 1:1 observation).' Patient scores for clinician-rated suicide risk: 0 (not suicidal); 1(occasional suicidal ideas, no intervention required);2(some clear suicidal ideas present),3(suicidal risk requires scheduled outpatient follow-up,no immediate intervention),4(suicidal risk requires immediate intervention, no hospitalization). 5( suicidal risk requires immediate hospitalization, no suicide precautions),6 (suicide risk requires hospitalization with suicide precautions). LOCF approach used for missing visit data in ITT LOCF efficacy analyses. Last post baseline observation was carried forward as End Point for follow up phase."|Baseline (Day 1-predose) to Follow-up Phase-Endpoint (Day 81)|The ITT (Follow Up phase) analysis set was defined as all participants who had at least one measurement of MADRS total score during the follow up phase.|||Units on a scale||Full Range|Median
2603335|NCT02133001|Secondary|Change From Baseline to Double-blind Phase-Endpoint (Day 25) Suicide Ideation and Behavior Assessment Tool (SIBAT)-Clinical Global Judgment of Suicide Risk (SIBAT CGJ-SR) Module 8 (Double-blind Phase)|"SIBAT CGJ-SR: Module 8 operates like numerous other CGI severity scales used in other psychiatric studies. Changes in CGJ-SR designed to categorize clinically meaningful changes in clinician rated suicide risk from 'not at all suicidal' to 'participant is at imminent risk of suicide and immediate need for strong intervention (hospitalization with 24 hour 1:1 observation).' Patient scores for clinician-rated suicide risk: 0 (not suicidal); 1(occasional suicidal ideas, no intervention required);2(some clear suicidal ideas present),3(suicidal risk requires scheduled outpatient follow-up,no immediate intervention),4(suicidal risk requires immediate intervention, no hospitalization). 5( suicidal risk requires immediate hospitalization, no suicide precautions),6 (suicide risk requires hospitalization with suicide precautions). LOCF approach used for missing visit data in ITT LOCF efficacy analyses. Last post baseline observation was carried forward as End Point for the double-blind phase."|Baseline (Day 1-predose) to Double-blind Phase-Endpoint (Day 25)|Intent-To-Treat Analysis (ITT) analysis set defined as all randomized participants who received at least 1 dose of study medication during the double-blind phase and had both the baseline and the Day 1-4 hour post dose evaluation for the MADRS total score.|||Units on a scale||Full Range|Median
2603336|NCT02133001|Secondary|Change From Baseline to Day 2 in Suicide Ideation and Behavior Assessment Tool (SIBAT)-Clinical Global Judgment of Suicide Risk (SIBAT CGJ-SR) Module 8 Score (Double-blind Phase)|SIBAT CGJ-SR: Module 8 operates like numerous other CGI severity scales used in other psychiatric studies. Changes in CGJ-SR designed to categorize clinically meaningful changes in clinician rated suicide risk from 'not at all suicidal' to 'participant is at imminent risk of suicide and immediate need for strong intervention (hospitalization with 24 hour 1:1 observation).' Patient scores for clinician-rated suicide risk: 0 (not suicidal); 1(occasional suicidal ideas, no intervention required);2(some clear suicidal ideas present),3(suicidal risk requires scheduled outpatient follow-up,no immediate intervention),4(suicidal risk requires immediate intervention, no hospitalization). 5( suicidal risk requires immediate hospitalization, no suicide precautions),6 (suicide risk requires hospitalization with suicide precautions). LOCF approach used for missing visit data in ITT LOCF efficacy analyses.|Baseline (Day 1-predose) to Day 2|ITT analysis set: all randomized participants who received at least 1 dose of study medication during the double-blind phase and had both the baseline and the Day 1-4 hour post dose evaluation for the MADRS total score.|||Units on a scale||Full Range|Median
2603337|NCT02133001|Secondary|Change From Baseline to Day 1: 4-hours Post-dose in Suicide Ideation and Behavior Assessment Tool (SIBAT)-Clinical Global Judgment of Suicide Risk (CGJ-SR) Module 8 Score (Double-blind Phase)|SIBAT CGJ-SR: Module 8 operates numerous clinical global impression (CGI) severity scales used in other psychiatric studies. Changes in CGJ-SR designed to categorize clinically meaningful changes in clinician rated suicide risk from 'not at all suicidal' to 'participant is at imminent risk of suicide and immediate need for strong intervention (hospitalization with 24 hour 1:1 observation).' Patient scores for clinician-rated suicide risk: 0 (not suicidal); 1(occasional suicidal ideas, no intervention required);2(some clear suicidal ideas present),3(suicidal risk requires scheduled outpatient follow-up,no immediate intervention),4(suicidal risk requires immediate intervention, no hospitalization). 5( suicidal risk requires immediate hospitalization, no suicide precautions),6 (suicide risk requires hospitalization with suicide precautions). LOCF approach used for missing visit data in ITT LOCF efficacy analyses.|Baseline (Day 1-predose) to Day 1: 4-hours Postdose|ITT analysis set: all randomized participants who received at least 1 dose of study medication during the double-blind phase and had both the baseline and the Day 1-4 hour post dose evaluation for the MADRS total score. Here N (overall number of participants analyzed)signifies number of participants who were evaluable for this endpoint.|||Units on a scale||Full Range|Median
2603338|NCT02133001|Secondary|Percentage of Participants With Response Based on MADRS Total Score at Follow up Phase Endpoint|Percentage of participants with response (greater than or equal to (>=) 50% improvement from baseline in MADRS total score) during the follow up was assessed. The MADRS consists of 10 items that cover all of the core depressive symptoms (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts). Each item is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptom). A total score (0 to 60) is calculated by adding the scores of all 10 items. For each item as well as the total score, a higher score represents a more severe condition.|Follow up phase-endpoint (Day 81)|The ITT (Follow Up phase) analysis set was defined as all participants who had at least one measurement of MADRS total score during the follow up phase.|||Percentage of participants|||Number
2603360|NCT02132936|Primary|Treatment Success According to the PGA|"To compare the efficacy of treatment of LEO 90100 at Week 4 to that of calcipotriol BDP gel at Week 8 in subjects with psoriasis vulgaris.~Five-point assessment (clear, almost clear, mild, moderate, and severe) was made for the severity of psoriasis vulgaris on the trunk and limbs at all on-treatment visits using Physician's Global Assessment of Disease Severity (PGA).~'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline."|4 Weeks for LEO 90100 and 8 weeks for calcipotriol BDP gel||||percentage of subjects|||Number
2603339|NCT02133001|Secondary|Percentage of Participants With Response Based on MADRS Total Score During the Double-Blind Phase|Percentage of participants with response (greater than or equal to (>=) 50% improvement from baseline in MADRS total score) during the double- blind phase was assessed. The MADRS consists of 10 items that cover all of the core depressive symptoms (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts). Each item is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptom). A total score (0 to 60) is calculated by adding the scores of all 10 items. For each item as well as the total score, a higher score represents a more severe condition.|Day 1 (4 hours postdose), Day 2 (double blind phase), Double blind phase -Endpoint (Day 25)|ITT analysis set defined as all randomized participants who received at least 1 dose of study medication during the double-blind phase and had both the baseline and the Day 1-4-hour post dose evaluation for the MADRS total score.|||Percentage of participants|||Number
2603340|NCT02133001|Secondary|Change From Baseline to Double-blind Phase-End Point (Day 25) in MADRS Total Score (Double-blind Phase)|"The MADRS consists of 10 items that cover all of the core depressive symptoms (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts). Each item is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptom). A total score (0 to 60) is calculated by adding the scores of all 10 items. For each item as well as the total score, a higher score represents a more severe condition. The LOCF approach was used for missing visit data in the ITT LOCF efficacy analyses. The last post baseline observation was carried forward as the End Point for the double-blind phase."|Baseline (Day 1-predose) to Double-blind Phase-End Point (Day 25)|Intent-To-Treat Analysis (ITT) analysis set defined as all randomized participants who received at least 1 dose of study medication during the double-blind phase and had both the baseline and the Day 1-4 hour post dose evaluation for the MADRS total score|||units on a scale||Standard Deviation|Mean
2603341|NCT02133001|Secondary|Change From Baseline to Day 2 in MADRS Total Score (Double-blind Phase)|The MADRS consists of 10 items that cover all of the core depressive symptoms (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts). Each item is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptom). A total score (0 to 60) is calculated by adding the scores of all 10 items. For each item as well as the total score, a higher score represents a more severe condition. The LOCF approach was used for missing visit data in the ITT LOCF efficacy analyses.|Baseline (Day 1-predose) to Day 2|Intent-To-Treat Analysis (ITT) analysis set defined as all randomized participants who received at least 1 dose of study medication during the double-blind phase and had both the baseline and the Day 1-4 hour post dose evaluation for the MADRS total score.|||Units on a scale||Standard Deviation|Mean
2603342|NCT02133001|Secondary|Percentage of Participants With Sustained Response Based on MADRS Total Score (Double-blind Phase)|Sustained response is defined as a reduction from baseline in MADRS total score of greater than or equal to 50 percent, with onset on Day 1 that is maintained through the end of the double-blind phase (Day 25). The MADRS consists of 10 items that cover all of the core depressive symptoms (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts). Each item is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptom). A total score (0 to 60) is calculated by adding the scores of all 10 items. For each item as well as the total score, a higher score represents a more severe condition. The LOCF approach was used for missing visit data in the ITT LOCF efficacy analyses.|Day 1 to Day 25|ITT analysis set defined as all randomized participants who received at least 1 dose of study medication during the double-blind phase and had both the baseline and the Day 1-4 hour post dose evaluation for the MADRS total score.|||Percentage of participants|||Number
2603343|NCT02133001|Primary|Change From Baseline to Day 1: 4-Hour Post-dose in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Double-blind Phase)|The MADRS consists of 10 items that cover all of the core depressive symptoms (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts). Each item is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptom). A total score (0 to 60) is calculated by adding the scores of all 10 items. For each item as well as the total score, a higher score represents a more severe condition. The last observation carried forward (LOCF) approach was used for missing visit data in the ITT LOCF efficacy analyses.|Baseline (Day 1-Predose) to Day 1: 4-hours post-dose|Intent-To-Treat Analysis (ITT) analysis set defined as all randomized participants who received at least 1 dose of study medication during the double-blind phase and had both the baseline and the Day 1-4 hour post dose evaluation for the MADRS total score.|||Units on a scale||Standard Deviation|Mean
2603344|NCT02132949|Secondary|Overall Survival (OS)|OS was defined as the time from enrollment to death from any cause.|Baseline up to death (approximately 6.5 years)|Because the study is ongoing, results of this end point are anticipated by December 2020.||||||
2603345|NCT02132949|Secondary|Invasive Disease Free Survival (iDFS) Determined by the Investigator According to RECIST v1.1|iDFS is defined as the time from the first date of no disease (the date of surgery) to the first documentation of progressive invasive disease, relapse, or death. PD: at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions.|Baseline until disease progression or death due to any cause up to approximately 6.5 years (assessed on Day 1 of Cycles 1-8 [cycle length=2-3 weeks] and every 3 months thereafter until study completion or early termination)|Because the study is ongoing, results of this end point are anticipated by December 2020.||||||
2603346|NCT02132949|Secondary|Event-Free Survival Determined by the Investigator According to RECIST v1.1|EFS is defined as the time from enrollment to the first occurrence of progressive disease, relapse, or death from any cause. PD: at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions.|Baseline until disease progression or death due to any cause up to approximately 6.5 years (assessed on Day 1 of Cycles 1-8 [cycle length=2-3 weeks] and every 3 months thereafter until study completion or early termination)|Because the study is ongoing, results of this end point are anticipated by December 2020.||||||
2603347|NCT02132949|Secondary|Percentage of Participants With Clinical Response as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 During the Neoadjuvant Treatment Period|Clinical response was classified as either complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD). CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD: neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. PD: at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. 95% CIs are calculated with the use of the Clopper-Pearson method.|Baseline until disease progression or death due to any cause up to 24 weeks (assessed on Day 1 of Cycles 1-8 [cycle length=2-3 weeks])|ITT population|||percentage of participants||95% Confidence Interval|Number
2603348|NCT02132949|Secondary|Percentage of Participants With Total Pathological Complete Response (tpCR) Evaluated at the Time of Surgery Based on Local Pathologist's Assessment After Surgery|tpCR is defined as the absence of any residual invasive cancer in the breast and the absence of any metastatic cells in the regional lymph nodes.|24 weeks after neoadjuvant therapy (Post 8 cycles of neo-adjuvant therapy [cycle length=2¬3 weeks])|ITT population|||percentage of participants||95% Confidence Interval|Number
2603349|NCT02132949|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Pertuzumab||Screening then prior to pertuzumab infusion (Hour 0) in Cycles 5, 14, 18 thereafter anytime between Cycle 8 Day 21 and surgery, up to treatment completion visit (cycle length=2-3 weeks; up to approximately 6.5 years)|"ITT population. Here, number of participants analyzed include those who were evaluable for the outcome."|||percentage of participants|||Number
2603350|NCT02132949|Secondary|Percentage of Participants With Drop in LVEF of at Least 10 Points From Baseline and to Below 50% at End of Study|A confirmed event was defined as at least two consecutive readings of declines in LVEF. 95% CIs will be calculated with the use of the Clopper-Pearson method.|Baseline up to approximately 6.5 years|Because the study is ongoing, results of this end point are anticipated by December 2020.||||||
2603351|NCT02132949|Secondary|Percentage of Participants With NYHA Class III and IV Heart Failure at the End of Study|LVSD is defined as heart failure. NYHA classifies participants' heart failure condition based on the participant's symptoms. Class III: marked limitation of the physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. 95% CIs will be calculated with the use of the Clopper-Pearson method.|Baseline up to approximately 6.5 years|Because the study is ongoing, results of this end point are anticipated by December 2020.||||||
2603352|NCT02132949|Secondary|Percentage of Participants With Drop in LVEF of at Least 10 Points From Baseline and to Below 50% During the Adjuvant Treatment Period at Primary Completion Date (03 March 2016)|A confirmed event was defined as at least two consecutive readings of declines in LVEF. 95% CIs was calculated with the use of the Clopper-Pearson method.|Cycle 9 to Cycle 21 (cycle length=3 weeks; up to approximately 8 months) up to clinical cut-off date, 03 March 2016 (Month 20)|Safety analysis population who have started adjuvant treatment and were analyzable at the clinical cut-off date (03 March 2016).|||percentage of participants||95% Confidence Interval|Number
2603353|NCT02132949|Secondary|Percentage of Participants With NYHA Class III and IV Heart Failure During the Adjuvant Treatment Period at Primary Completion Date (03 March 2016)|LVSD is defined as heart failure. NYHA classifies participants' heart failure condition based on the participant's symptoms. Class III: marked limitation of the physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. 95% CIs was calculated with the use of the Clopper-Pearson method.|Cycle 9 to Cycle 21 (cycle length=3 weeks; up to approximately 8 months) up to clinical cut-off date, 03 March 2016 (Month 20)|Safety analysis population who have started adjuvant treatment and were analyzable at the clinical cut-off date (03 March 2016).|||percentage of participants||95% Confidence Interval|Number
2603354|NCT02132949|Primary|Percentage of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) of at Least 10 Percentage Points From Baseline and to Below 50% During the Neoadjuvant Treatment Period|A confirmed event was defined as at least two consecutive readings of declines in LVEF. 95% CIs are calculated with the use of the Clopper-Pearson method.|Baseline to 24 weeks|Safety analysis population|||percentage of participants||95% Confidence Interval|Number
2603355|NCT02132949|Primary|Percentage of Participants With New York Heart Association (NYHA) Class III and IV Heart Failure During the Neoadjuvant Treatment Period|Symptomatic left ventricular systolic dysfunction (LVSD) is defined as heart failure. NYHA classifies participants' heart failure condition based on the participant's symptoms. Class III: marked limitation of the physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. 95 percent (%) confidence intervals (CIs) are calculated with the use of the Clopper-Pearson method.|Baseline to 24 weeks|Safety analysis population included all participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
2603356|NCT02132936|Secondary|Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel).|Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).|Baseline to Week 4; Baseline to Week 8||||units on a scale||95% Confidence Interval|Mean
2603357|NCT02132936|Secondary|Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group).|Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale (VAS) - range from 0 (no itch at all) to 100 mm (worst itch one could imagine).|Baseline to Week 4||||units on a scale||95% Confidence Interval|Mean
2603358|NCT02132936|Secondary|Time to 'Treatment Success' According to PGA.|"Time to treatment success was calculated as the number of weeks from baseline to the visit where the subject first achieved treatment success.~'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline."|From Baseline to Week 12||||weeks||Inter-Quartile Range|Median
2603364|NCT02132910|Primary|Pain Scores|"Participants will choose a pain score using the Defense and Veteran's Pain Rating Scale 2.0~Rate the severity of your CURRENT pain:~0 - No Pain~- Hardly notice pain~- Notice pain, does not interfere with activities~- Sometimes distracts me~- Distracts me, can do usual activities~- Interrupts some activities~- Hard to ignore, avoid usual activities~- Focus of attention, prevents doing daily activities~- Awful, hard to do anything~- Can't bear pain, unable to do anything~- As bad as it could be, nothing else matters~Higher values represent worse outcomes"|Baseline, Midtreatment, Posttreatment, 3 month follow-up, 6 month follow-up||||units on a scale||Standard Deviation|Mean
2603365|NCT02132884|Other Pre-specified|Progression Free Survival (Arm A)|The progression free survival of those patients in Arm A who undergo molecular testing (by any method) at the discretion of the treating physician will be estimated.|Time from start of second line treatment to time of progression or death, whichever occurs first, assessed up to 2 year|||||||
2603366|NCT02132884|Other Pre-specified|Response Rate Defined by RECIST 1.1 (Arm A)|The response rate of those patients in Arm A who undergo molecular testing (by any method) at the discretion of the treating physician will be estimated.|Up to 2 years|||||||
2603367|NCT02132884|Other Pre-specified|Incidence of Non-protocol Testing (Arm A)|The incidence of non-protocol testing of those patients in Arm A who undergo molecular testing (by any method) at the discretion of the treating physician will be estimated.|Up to 2 years|||||||
2603368|NCT02132884|Other Pre-specified|Concordance of Variants (Arm B)|The concordance of variants identified when sequencing will be performed on samples from the same patient collected at baseline and follow-up time points will also be measured.|Up to 2 years|||||||
2603369|NCT02132884|Secondary|Proportion of Arm B Patients Whose Second Line Therapy is Changed as a Result of Physician Access to CancerCode-50 Results|To assess the effect of sequencing on clinical practice and decision making the proportion of Arm B patients whose second line therapy is changed as a result of physician access to CancerCode-50 results will be computed. This comparison will be based on information provided by the treating physician before being exposed to the sequencing results, and information obtained from a from post-treatment chart review.|Up to 2 years|There was only one patient enrolled and the study was closed before the patient started treatment.||||||
2603370|NCT02132884|Secondary|Response Rate Defined by RECIST 1.1|The response rate (with 95% two-sided confidence intervals) will be computed separately by arm. One-sided chi-square or Fisher's exact tests (alpha = .1) will be used to evaluate differences in response rates between arms.|Up to 2 years|There was only one patient enrolled and the study was closed before the patient started treatment.||||||
2603371|NCT02132884|Primary|Progression Free Survival|"A chi-square test (one-sided; alpha = .1) will be used to assess the efficacy of treating patients with targeted agents based in the Cancer-Code-50 in the second line setting. For each patient success will be defined as being progression free for at least 3 months following initiation of second line therapy. Progression free survival times will be characterized separately by arm using the method of Kaplan and Meier."|Time from start of second line treatment to time of progression or death, whichever occurs first, assessed at 3 months|There was only one patient enrolled and the study was closed before the patient started treatment.||||||
2603372|NCT02132832|Primary|Stress as Assessed by the Visual Analogue Stress Scale-Current (VASS-C)|"With the Visual Analogue Stress Scale - Current (VASS-C), current stress level is ranked on a 0 - 10 visual analog scale, with 0 as no stress and 10 as extreme stress, cued by the question Please rate your current stress level."|week 3||||units on a scale||Standard Deviation|Mean
2603373|NCT02132832|Primary|Stress as Assessed by the Visual Analogue Stress Scale-Current (VASS-C)|"With the Visual Analogue Stress Scale - Current (VASS-C), current stress level is ranked on a 0 - 10 visual analog scale, with 0 as no stress and 10 as extreme stress, cued by the question Please rate your current stress level."|week 2||||units on a scale||Standard Deviation|Mean
2603374|NCT02132832|Primary|Stress as Assessed by the Visual Analogue Stress Scale-Current (VASS-C)|"With the Visual Analogue Stress Scale - Current (VASS-C), current stress level is ranked on a 0 - 10 visual analog scale, with 0 as no stress and 10 as extreme stress, cued by the question Please rate your current stress level."|week 1||||units on a scale||Standard Deviation|Mean
2603375|NCT02132832|Primary|Anxiety as Assessed by the Zung Self-Rated Anxiety Scale|"The Zung Self-Rated Anxiety Scale is a widely-used 20 item scale that is scored on a Likert-type scale of 1-4, with 15 questions concerning increasing anxiety levels and five questions concerning decreasing anxiety levels. The scale focuses on the most common general anxiety symptoms and means of coping with stressors that produce anxiety. The range of scores is 20-80:~20-44 Normal Range~45-59 Mild to Moderate Anxiety Levels~60-74 Marked to Severe Anxiety Levels~75-80 Extreme Anxiety Levels"|week 3||||units on a scale||Standard Deviation|Mean
2603376|NCT02132832|Primary|Anxiety as Assessed by the Zung Self-Rated Anxiety Scale|"The Zung Self-Rated Anxiety Scale is a widely-used 20 item scale that is scored on a Likert-type scale of 1-4, with 15 questions concerning increasing anxiety levels and five questions concerning decreasing anxiety levels. The scale focuses on the most common general anxiety symptoms and means of coping with stressors that produce anxiety. The range of scores is 20-80:~20-44 Normal Range~45-59 Mild to Moderate Anxiety Levels~60-74 Marked to Severe Anxiety Levels~75-80 Extreme Anxiety Levels"|week 2||||units on a scale||Standard Deviation|Mean
2603377|NCT02132832|Primary|Anxiety as Assessed by the Zung Self-Rated Anxiety Scale|"The Zung Self-Rated Anxiety Scale is a widely-used 20 item scale that is scored on a Likert-type scale of 1-4, with 15 questions concerning increasing anxiety levels and five questions concerning decreasing anxiety levels. The scale focuses on the most common general anxiety symptoms and means of coping with stressors that produce anxiety. The range of scores is 20-80:~20-44 Normal Range~45-59 Mild to Moderate Anxiety Levels~60-74 Marked to Severe Anxiety Levels~75-80 Extreme Anxiety Levels"|week 1||||units on a scale||Standard Deviation|Mean
2603378|NCT02132832|Primary|Stress as Assessed by the Perceived Stress Scale|The Perceived Stress Scale is a 10 item scale that was developed to measure the degree to which individuals appraise their life as stressful and has been widely used in health studies. The scale has a 5-point Likert response format. The total score is calculated by summing responses. The questions are general in nature and relatively content free with regard to specific population groups. The range of scores is 0-40, with 40 indicating the most stress.|week 3||||units on a scale||Standard Deviation|Mean
2623568|NCT01929460|Secondary|Mean Cyst Fluid Carcinoembryonic Antigen (CEA)|Mean cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions|six weeks||||ng/mL||Full Range|Mean
2603379|NCT02132832|Primary|Stress as Assessed by the Perceived Stress Scale|The Perceived Stress Scale is a 10 item scale that was developed to measure the degree to which individuals appraise their life as stressful and has been widely used in health studies. The scale has a 5-point Likert response format. The total score is calculated by summing responses. The questions are general in nature and relatively content free with regard to specific population groups. The range of scores is 0-40, with 40 indicating the most stress.|week 2||||units on a scale||Standard Deviation|Mean
2603380|NCT02132832|Primary|Stress as Assessed by the Perceived Stress Scale|The Perceived Stress Scale is a 10 item scale that was developed to measure the degree to which individuals appraise their life as stressful and has been widely used in health studies. The scale has a 5-point Likert response format. The total score is calculated by summing responses. The questions are general in nature and relatively content free with regard to specific population groups. The range of scores is 0-40, with 40 indicating the most stress.|week 1||||units on a scale||Standard Deviation|Mean
2603381|NCT02132832|Primary|Attentional Bias to Marijuana Specific Stimuli Measured Via Analysis of Eye Movements|Eye movements are analyzed using a MiraMetrix S2 Eyetracker. This outcome measure reports a ratio: [(number of anti-saccade errors with marijuana-related images) divided by (total number of anti-saccade errors with marijuana-related images or neutral images)]. Anti-saccade errors are when the subject fails to inhibit fixation onto the image.|week 3||||ratio of errors (see OM description)||Standard Deviation|Mean
2603382|NCT02132832|Primary|Attentional Bias to Marijuana Specific Stimuli Measured Via Analysis of Eye Movements|Eye movements are analyzed using a MiraMetrix S2 Eyetracker. This outcome measure reports a ratio: [(number of anti-saccade errors with marijuana-related images) divided by (total number of anti-saccade errors with marijuana-related images or neutral images)]. Anti-saccade errors are when the subject fails to inhibit fixation onto the image.|week 2||||ratio of errors (see OM description)||Standard Deviation|Mean
2603383|NCT02132832|Primary|Attentional Bias to Marijuana Specific Stimuli Measured Via Analysis of Eye Movements|Eye movements are analyzed using a MiraMetrix S2 Eyetracker. This outcome measure reports a ratio: [(number of anti-saccade errors with marijuana-related images) divided by (total number of anti-saccade errors with marijuana-related images or neutral images)]. Anti-saccade errors are when the subject fails to inhibit fixation onto the image.|week 1||||ratio of errors (see OM description)||Standard Deviation|Mean
2603384|NCT02132767|Secondary|Cost (Hospital)|Compare cost of index hospitalization and cost of rehospitalizations (including ED visits) between groups|Within 60 days of randomization|||||||
2603385|NCT02132767|Secondary|AF- or Treatment-related Events||Within 60 days of randomization|||||||
2603386|NCT02132767|Secondary|Outpatient Interventions|Compare frequency of outpatient visits between groups for any cause and AF-related causes|Within 60 days of randomization||||hospital stays < 24 hours|||Number
2603387|NCT02132767|Secondary|Length of Stay (Rehospitalization, Including ED Visits)|Compare length of stay between groups for any cause and AF-related hospitalizations, including ED visits|Within 60 days of randomization||||days||Inter-Quartile Range|Median
2603388|NCT02132767|Secondary|Length of Stay (Index Hospitalization)|Overall length of stay for the index hospitalization|Within 60 days post surgery||||days||Inter-Quartile Range|Median
2603389|NCT02132767|Secondary|Heart Rhythm Comparison|Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at 60 days after randomization|60 days after randomization||||participants|||Number
2603390|NCT02132767|Secondary|Heart Rhythm Comparison|Compare heart rhythm (patients in sustained, stable non-AF rhythm) between treatment arms at 30 days after randomization|30 days after randomization||||participants|||Number
2603391|NCT02132767|Secondary|Heart Rhythm Comparison|Compare heart rhythm (number of patients in sustained, stable non-AF rhythm) between treatment arms at hospital discharge|Hospital discharge||||participants|||Number
2603392|NCT02132767|Secondary|Time to Conversion to Sustained, Stable Non-AF Rhythm||Up to index hospital discharge or 7 days post surgery, whichever came first|All randomized patients (intent to treat)|||days||Inter-Quartile Range|Median
2603393|NCT02132767|Primary|Total Number of Days in Hospital|The total number of days in hospital for any hospitalization that occurs within 60 days of randomization to AF treatment strategy.|Within 60 days of randomization|All randomized patients (intent to treat)|||days||Inter-Quartile Range|Median
2603394|NCT02132637|Secondary|Beta Cell Function|Beta cell function assessed by the change between pre meal tolerance test and 30 minutes post meal tolerance test in C-peptide corrected insulin/Glucose (ΔC-peptide corrected insulin/ΔGlucose). LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor.|0-30 minutes during the meal tolerance test on the day following the standard dose|All randomized participants who received at least one dose of study drug and had evaluable ΔC-peptide data were included in the analysis.|||mmol/L||Standard Error|Least Squares Mean
2603395|NCT02132637|Secondary|Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC) Excursion|Glucose AUC excursion within 3 hours after each meal assessed by the AUC of adjusted glucose (= observed glucose - preprandial glucose) from preprandial to 3 hours postprandial. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor.|Preprandial to 3 Hours Postprandial during the day following the standard dose|All randomized participants who received at least one dose of study drug and had evaluable glucose data were included in the analysis.|||mg/dL*h||Standard Error|Least Squares Mean
2603396|NCT02132637|Secondary|Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC)|Glucose AUC within 3 hours after each meal assessed by the AUC of glucose from preprandial to 3 hours postprandial. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor.|Preprandial to 3 Hours Postprandial during the day following the standard dose|All randomized participants who received at least one dose of study drug and had evaluable glucose data were included in the analysis.|||mg/dL*h||Standard Error|Least Squares Mean
2603471|NCT02131532|Secondary|SIS - Memory and Thinking|The memory and thinking subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
2603397|NCT02132637|Secondary|Fasting Blood Glucose|Fasting blood glucose (FBG) was measured by self-monitored blood glucose. LS means were calculated by MMRM analysis with fixed effects of treatment, dosing day, sequence, period, interaction of treatment and dosing day, baseline basal insulin dose stratification factor, and baseline FBG.|Day 1, Day 2, and Day 3 Following Double Dose|All randomized participants who received the double dose of study drug and had evaluable fasting blood glucose data were included in the analysis.|||mg/dL||Standard Error|Least Squares Mean
2603398|NCT02132637|Secondary|Duration of Glucose ≤70 mg/dL|The duration in minutes of each hypoglycemia episode with glucose ≤70 mg/dL (3.9 mmol/L) was calculated from start time to end time. The duration for a participant was the sum of the durations over the multiple hypoglycemia episodes. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor.|Predose to 84 Hours Post Double Dose|All randomized participants who received the double dose of study drug and had evaluable hypoglycemia data were included in the analysis.|||Minutes per participant||Standard Error|Least Squares Mean
2603399|NCT02132637|Secondary|Time to the Nadir Glucose|Nadir glucose was defined as the lowest blood glucose for a participant with blood glucose ≤70 mg/dL (3.9 mmol/L). The average time was calculated by dividing the sum of time from double dose to the nadir glucose for participants with blood glucose ≤70 mg/dL (3.9 mmol/L) by the number of participants with blood glucose ≤70 mg/dL (3.9 mmol/L) during the first 84 hours after the double dose.|Predose to 84 Hours Post Double Dose|All randomized participants who received the double dose of study drug and had blood glucose ≤70 mg/dL (3.9 mmol/L) during the first 84 hours after the double dose were included in the analysis.|||hours||Standard Deviation|Mean
2603400|NCT02132637|Secondary|Nadir Glucose|Nadir glucose was defined as the lowest blood glucose for a participant with blood glucose ≤70 mg/dL (3.9 mmol/L). Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor.|Predose to 84 Hours Post Double Dose|All randomized participants who received the double dose of study drug and had blood glucose ≤70 mg/dL (3.9 mmol/L) during the first 84 hours after the double dose were included in the analysis.|||mg/dL||Standard Error|Least Squares Mean
2603401|NCT02132637|Secondary|Percentage of Participants With Hypoglycemia|The percentage was calculated by dividing the number of participants with hypoglycemia events defined as blood glucose ≤70 mg/dL (3.9 mmol/L) by the total number of participants analyzed, multiplied by 100.|Predose to 12 Hours Post Double Dose and 84 Hours Post Double Dose|All randomized participants who received the double dose of study drug and had evaluable hypoglycemia data were included in the analysis.|||percentage of participants|||Number
2603402|NCT02132637|Secondary|Percentage of Participants With Clinically Significant Hypoglycemia 12 Hours Post Double Dose|The percentage was calculated by dividing the number of participants with clinically significant hypoglycemia events defined as blood glucose <54 mg/dL (3.0 mmol/L) or symptoms of severe hypoglycemia by the total number of participants analyzed, multiplied by 100.|Predose to 12 Hours Post Double Dose|All randomized participants who received the double dose of study drug and had evaluable hypoglycemia data were included in the analysis.|||percentage of participants|||Number
2603403|NCT02132637|Primary|Percentage of Participants With Clinically Significant Hypoglycemia|The percentage was calculated by dividing the number of participants with clinically significant hypoglycemia events defined as blood glucose <54 milligrams per deciliter (mg/dL) (3.0 millimole per liter [mmol/L]) or symptoms of severe hypoglycemia by the total number of participants analyzed, multiplied by 100.|Predose to 84 Hours Post Double Dose|All randomized participants who received the double dose of study drug and had evaluable hypoglycemia data were included in the analysis.|||percentage of participants|||Number
2603404|NCT02132611|Secondary|Procedural Success|Procedural success was defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE in de novo, severely calcified coronary lesions.|Participants were followed from baseline procedure through the duration of hospital stay, an average of 50.4 hours||||percentage of procedures||95% Confidence Interval|Number
2603405|NCT02132611|Primary|Major Adverse Cardiac Event (MACE)|"A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 30 days.~30-Day MACE is composed of:~Cardiac death~Myocardial Infarction (MI) - defined as a Creatine Kinase Myocardial-Band Isoenzyme (CK-MB) level greater than three (3) times the Upper Limit of Lab Normal (ULN) value with or without new pathologic Q wave~Target Vessel Revascularization (TVR) - defined as a revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure"|30 Days||||Percent Probability of Freedom from MACE||95% Confidence Interval|Number
2603406|NCT02132572|Primary|Percentage of Subjects With First Reoperation Following Use of a BIOCELL™ Textured 410 Implant|Data were retrospectively collected on the percentage of subjects who had a first reoperation following previous breast augmentation with a BIOCELL™ Textured 410 Implant.|3 to 10 years|Per Protocol: Subjects who underwent a primary breast augmentation with BIOCELL™ textured 410 cohesive breast implants 3 to 10 years prior to data collection|||Percentage of Subjects|||Number
2603407|NCT02132533|Secondary|Preterm Birth||Within 7 days of randomization||||Participants|||Count of Participants
2603408|NCT02132533|Secondary|At Least 2 Doses of Betamethasone Administered||Prior to delivery||||Participants|||Count of Participants
2603409|NCT02132533|Secondary|Preterm Birth||Within 48 hours of randomization||||Participants|||Count of Participants
2603410|NCT02132533|Primary|Preterm Birth||Less than 37 weeks of gestation||||Participants|||Count of Participants
2603411|NCT02132520|Other Pre-specified|Changes in the Resting Motor Threshold|The resting motor threshold is a measure of cortical excitability, and will be recorded for both the stroke and non-stroke hemispheres.|Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)|||||||
2603412|NCT02132520|Other Pre-specified|Subject Report of Symptoms|The subject report of symptoms assesses whether subject experience any adverse effects as a result of participation in the study.|within 12 weeks of participation|||||||
2603427|NCT02132195|Primary|Number of Participants Experienced a Relapse of Nephrotic Syndrome|Number of participants experienced a relapse of nephrotic syndrome during the initial 6 months of the study.|6 months|The primary outcome measure was accessed during the initial 6 months based on initial assignment, rescue therapy group was not part of the analysis.|||Participants|||Count of Participants
2603413|NCT02132520|Secondary|Changes in Inter-hemispheric Inhibition|Inter-hemispheric Inhibition was evaluated using paired-pulse TMS both for the stroke hemisphere to non-stroke hemisphere direction as well as for the non-stroke hemisphere to the stroke hemisphere direction. IHI was measured by applying TMS to identified left and right motor hotspots at 1 mV threshold intensity, or 130% of the RMT if 1 mV threshold could not be identified, with single unilateral pulses and paired bilateral pulses. IHI was quantified by comparing the paired-pulse peak-to-peak motor evoked potential amplitudes to the corresponding single pulse MEP amplitudes for each direction of stimulation (ipsi- to contra-lesional and contra- to ipsi-lesional).|Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)||||PP/SP ratio||Full Range|Mean
2603414|NCT02132520|Secondary|Changes in Paretic Hand Motor Function as Measured by the Finger Tracking Test|The finger tracking test evaluates the subject's ability to track an oscillating wave with either their paretic or non-paretic finger. Subjects wore custom electro-goniometer braces on each hand, each of which included a potentiometer signaling extension and flexion of the index finger metacarpophalangeal joint. Subjects were presented with target stimuli with a random sinusoidal waveform and were instructed to move the corresponding index finger to match the target trace as the cursor moved across the screen with constant velocity. Performance was quantified by an accuracy index, calculated using the ratio of the error to the standard deviation of the target, normalized to the range of motion for each subject.|Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)||||Accuracy index||Full Range|Mean
2603415|NCT02132520|Secondary|Changes in Hand Motor Function as Measured by the Box and Block Test|Performance on the box and block test with the paretic hand, quantified as the number of 2.5 cm^3 cubes grasped, lifted, and released to transfer between compartments correctly within 60 seconds.|Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)||||Number of blocks||Full Range|Mean
2603416|NCT02132520|Primary|Changes in Cortical Excitability and Cortical Activation Patterns as Measured by MRI and Functional MRI|The MRI and functional MRI will evaluate the extent to which cortical areas are recruited both during rest and during movement related tasks. This is quantified by a laterality index, calculated as the ratio of activations of ipsi- and contra-lesional precentral gyri during a paretic hand tracking task. A LI of -1 corresponds to entirely contralesional activation, while a value of +1 corresponds to entirely ipsilesional activation.|Baseline, Post-Test 1 (3 weeks), Post-Test 2 (6 weeks)|The laterality index was not calculated for one subject in post-test 2 as no activation overlapped with the ipsilesional or contralesional precentral gyrus.|||Laterality index||Full Range|Mean
2603417|NCT02132468|Secondary|Number of Participants With Partial Response (PR), Progressive Disease (PD), or Stable Disease (SD) Based on RECIST 1.1|The objective response rate (complete response, partial response, progressive disease, or stable disease) was determined by the investigator assessment of the participant's CT or MRI using Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) for target lesions. Partial Response (PR) is when there is at least 30% decrease in sum of the longest diameter of the target lesions. Progressive Disease (PD) is when there is at least 20% increase in the sum of the longest diameter of the target lesions, as well as an absolute increase of at least 5 mm (including appearance of new lesions). Stable Disease (SD) is when there neither a PR nor PD is noted.|Baseline and 4 months|Modified Intent-to-Treat|||Participants|||Count of Participants
2603418|NCT02132468|Primary|Number of Participants With Improved, Stable, or Worsened Change In Serotonin Biomarker Levels From Baseline|The mean change from baseline in serotonin biomarker level is considered improved if a 25% reduction occurs and worsened if the mean change from baseline is increased by 25%.|Baseline and 4 months|Participants who had serotonin biomaker samples taken at baseline and at 4 months.|||Participants|||Count of Participants
2603419|NCT02132468|Primary|Number of Participants With Improved, Stable, or Worsened Change In 5-hydroxyindoleacetic Acid (5-HIAA) Biomarker Levels From Baseline|The mean change from baseline in 5-hydroxyindoleacetic acid (5-HIAA) biomarker level is considered improved if a 25% reduction occurs and worsened if the mean change from baseline is increased by 25%.|Baseline and 4 months|Participants who had 5-hydroxyindoleacetic acid (5-HIAA) biomaker sample taken at baseline and at 4 months.|||Participants|||Count of Participants
2603420|NCT02132468|Primary|Number of Participants With Improved, Stable, or Worsened Change In Chromogranin A (CgA) Biomarker Levels From Baseline|The mean change from baseline in chromogranin A (CgA) biomarker level is considered improved if a 25% reduction occurs and worsened if the mean change from baseline is increased by 25%.|Baseline and 4 months|Safety Population|||Participants|||Count of Participants
2603421|NCT02132247|Secondary|Plasma Concentration of Diclofenac||Day 2 and either Day 4, 7 or 14, depending upon pain resolution|One participant missed a blood draw.|||ng/mL||Standard Deviation|Mean
2603422|NCT02132247|Secondary|Patient Assessment of Pain on a 6-point Scale|"Wong-Baker FACES Scale 6-point scale:~No Hurt - 0; Hurts Little Bit - 1; Hurts Little More - 2; Hurts Even More - 3; Hurts Whole Lot - 4; Hurts Worst - 5."|Up to 2 weeks, depending upon pain resolution||||units on a scale||Standard Deviation|Mean
2603423|NCT02132247|Secondary|Investigator Assessment of the Global Response to Therapy on a 5-point Scale|5-point scale: No clinical improvement in pain intensity and/or functional performance - 1; Slight clinical improvement in pain intensity and/or functional performance - 2; Moderate clinical improvement in pain intensity and/or functional performance - 3; Marked clinical improvement in pain intensity and/or functional performance - 4; Restoration of normal functional performance in the absence of any pain - 5.|Up to 2 weeks, depending upon pain resolution||||Participants|||Count of Participants
2603424|NCT02132247|Primary|Dermatologic Assessment at the Patch Application Site|None - 0; Faint redness - 1; Moderate redness - 2; Intense redness - 3; Redness with edema or papules - 4; Redness with weeping vesicles, blisters or bullae - 5; Redness with extension of effect beyond margin of contact site - 6.|Up to 2 weeks, depending upon pain resolution||||Units on a scale||Standard Deviation|Mean
2603425|NCT02132195|Secondary|Number of Adverse Events|Adverse events will be collected (SAEs and AEs)|12 months|15 pts randomized to receive ACTH, and 16 pts randomized to No-treatment. 13 patients in No-treatment arm elected to receive ACTH as rescue therapy.|||number of events|||Number
2603426|NCT02132195|Secondary|Number of Participants Experiencing Relapses After Dose Reduction of ACTH|The dose of ACTH will be reduced by 50% after 6 months and the rate of relapse during this period will be evaluated.|6 to 12 months|Three participants who completed 6 months of ACTH Full Dose therapy and then 6 months of Reduced Dose ACTH - inclusive of one subject initially randomized to ACTH and two subjects who received ACTH as rescue treatment|||Participants|||Count of Participants
2603429|NCT02132169|Primary|Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22)|Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2603430|NCT02132169|Primary|Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8)|Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2603431|NCT02132169|Primary|Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1)|Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2603432|NCT02132117|Secondary|Percentage of Participants With at Least a 1-Grade Improvement (Decrease) From Baseline on SSA at Hour 1 on Day 1|The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement.|Baseline, Day 1 (Hour 1)|ITT Population included all randomized participants.|||percentage of participants|||Number
2603433|NCT02132117|Secondary|Change From Baseline on the Symptom Assessment for Rosacea Facial Redness (SA-RFR) Item # 4 at Hours 3, 6, 9 and 12 on Day 29|"Participants assessed the burning sensation associated with rosacea facial redness by answering Item #4 of the SA-RFR: Right now, how much does your face burn because of your facial redness? using a 5-point scale where 0=less severe to 4=severe. A negative change from Baseline indicates improvement."|Baseline, Day 29 (Hours 3, 6, 9 and 12)|Participants from the ITT Population, all randomized participants, with data available for analysis at the given time-point. Only participants who had a SA-RFR score of 1-4 at Baseline are included in the Analysis.|||score on a scale||Standard Deviation|Mean
2603434|NCT02132117|Secondary|Percentage of Participants Satisfied or Very Satisfied on Item #9 of Satisfaction Assessment for Rosacea Facial Redness (SAT-RFR) at Hours 3, 6, 9 and 12 on Day 29|"Participants assessed their treatment satisfaction by answering Item #9 of the SAT-RFR: Right now, how satisfied are you with the effect your study medication had on your facial redness? using a 5-point scale where 0= very dissatisfied, 1=dissatisfied, 2=neither satisfied or dissatisfied, 3=satisfied, or 4=very satisfied. The percentage of participants who answered Satisfied or Very Satisfied is reported."|Day 29 (Hours 3, 6, 9 and 12)|Participants from the ITT Population, all randomized participants with data available for analysis.|||percentage of participants|||Number
2603435|NCT02132117|Secondary|Percent Change From Baseline on Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA) at Hours 3, 6, 9 and 12 on Day 29|DIA of photographs was used to assess rosacea facial redness and was defined as percentage of facial area occupied by redness. A higher value in the percentage of facial area occupied by facial redness indicated more redness. A negative/ lower number percent change from Baseline indicates improvement.|Baseline, Day 29 (Hours 3, 6, 9 and 12)|ITT Population included all randomized participants.|||percent change in area of redness||Full Range|Median
2603436|NCT02132117|Secondary|Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on SSA at Hours 3, 6, 9 and 12 on Day 29|The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on SSA from Baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) post-dose on Day 29.|Baseline, Day 29 (Hours 3, 6, 9 and 12)|ITT Population included all randomized participants.|||percentage of participants|||Number
2603437|NCT02132117|Primary|Percentage of Participants With at Least a 2-Grade Improvement (Decrease) From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment for Rosacea Facial Redness (SSA) 5-point Scales|The investigator assessed the participant's overall severity of erythema in the treatment area by using the 5-point CEA scale with photonumeric guide where: 0=clear skin with no signs of erythema (best) to 4=severe erythema; fiery redness (worst). A decrease in the score indicates improvement. The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on both CEA and SSA from Baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) post-dose on Day 29. Baseline was defined as the measurement at pre-dose on Day 1.|Baseline, Day 29 (Hours 3, 6, 9 and 12)|Intent-to-treat (ITT) Population included all randomized participants.|||percentage of participants|||Number
2603438|NCT02131766|Secondary|Morning Glucose Levels|Assess the distribution of wake-up glucose levels at 07:00 achieved by USS Virginia Closed Loop vs. to sensor-augmented pump therapy alone;|40 hours|Cross-over trial with a total of 40 participants|||mg/dL||Standard Deviation|Mean
2603439|NCT02131766|Secondary|Decreased Overnight Hypoglycemia|Assess the effect of USS Virginia Closed Loop System to decrease hypoglycemia overnight compared to sensor-augmented pump therapy alone|40 hours|Cross-over trial with a total of 40 participants|||percentage of time overnight||Standard Deviation|Mean
2603440|NCT02131766|Secondary|Overnight Target Range|Assess time spent within target range of 80-140 mg/dl overnight with USS Virginia Closed Loop compared to sensor-augmented pump therapy alone|40 hours|Cross-over trial for a total of 40 participants|||percentage of time overnight||Standard Deviation|Mean
2603441|NCT02131766|Primary|USS Virginia Time Within Target|Assess the effect size of USS Virginia in increasing time within target (70-180 mg/dL) over a 24-hour period with closed-loop control overnight (23:00 to 07:00) as compared to sensor-augmented pump alone.|40 hours|Cross-over trial with same subjects participating in both arms for a total of 40 subjects.|||percentage of time spent in range||Standard Deviation|Mean
2623569|NCT01929460|Secondary|Procedure-related Complications|Number of patients with procedure-related complications|six weeks after procedure||||participants|||Number
2603442|NCT02131662|Other Pre-specified|Estimated Dose-response Curve Based on Amenorrhea - δ|The primary objective was to estimate the dose-response curve based on the primary endpoint: subjects with amenorrhea. The number of subjects with amenorrhea was assumed to be binomial distributed. A 4 parameters logistic model was used to fit the observed data for characterizing the dose-response curve: E0, Emax, ED50 and δ. The model is defined as p(d)=E0 + Emax/{1+ e^[{ED50-d)/δ]}. δ is hill slope parameter which measures sensitivity of the response to the dose range of the drug, determining the steepness of the dose-response curve.|After end of the initial bleeding episode until the end of treatment||||Slope|||Number
2603443|NCT02131662|Other Pre-specified|Estimated Dose-response Curve Based on Amenorrhea - ED50|The primary objective was to estimate the dose-response curve based on the primary endpoint: subjects with amenorrhea. The number of subjects with amenorrhea was assumed to be binomial distributed. A 4 parameters logistic model was used to fit the observed data for characterizing the dose-response curve: E0, Emax, ED50 and δ. The model is defined as p(d)=E0 + Emax/{1+ e^[{ED50-d)/δ]}. ED50 is the dose at which 50% of Emax were achieved.|After end of the initial bleeding episode until the end of treatment||||mg|||Number
2603444|NCT02131662|Other Pre-specified|Estimated Dose-response Curve Based on Amenorrhea - E0 and Emax|The primary objective was to estimate the dose-response curve based on the primary endpoint: subjects with amenorrhea. The number of subjects with amenorrhea was assumed to be binomial distributed. A 4 parameters logistic model was used to fit the observed data for characterizing the dose-response curve: E0, Emax, ED50 and δ. The model is defined as p(d)=E0 + Emax/{1+ e^[{ED50-d)/δ]}. E0 is the amenorrhea rate for placebo; Emax is the maximum effect attributable to the drug (compared with the basal effect with dose at d=0 [placebo group], the maximum increase of drug effect).|After end of the initial bleeding episode until the end of treatment||||Percentage|||Number
2603445|NCT02131662|Other Pre-specified|Percentage of Subjects With HMB Response During the Last 28 Days of Treatment||Last 28 Days of Treatment||||Percentage of subjects|||Number
2603446|NCT02131662|Other Pre-specified|Percentage of Subjects With Amenorrhea (Defined as MBL < 2 mL) During the Last 28 Days of Treatment||Last 28 Days of Treatment||||Percentage of subjects|||Number
2603447|NCT02131662|Other Pre-specified|Assessment of MP to Identify Subjects With Heavy Menstrual Bleeding (HMB)|The ability of the MP to identify subjects with HMB (defined as > 80 mL of blood loss during bleeding episode) per 28 days against the the current gold standard (i.e. AH method) was assessed. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of MP method for detecting heavy menstrual bleeding were calculated against AH method. Sensitivity = true positive/(true positive + false negative)*100; Specificity = true negative/(true negative + false positive)*100; PPV = true positive/(true positive + false positive)*100; NPV = true negative/(true negative + false negative)*100. MP version 2014 was originally defined based on studies in healthy subjects. And MP version 2016 was developed for study population of women with heavy bleeding.|At baseline|An analysis set for the assessment of the interchangeability of the MP and the AH method to judge MBL included all screened subjects (except subjects in Japan) with any sanitary product data for which there is any matching pair of MP score and AH value available. A total of 399 subjects were included in this analysis set.|||Percentage|||Number
2603448|NCT02131662|Other Pre-specified|Exposure-response Analysis of Vilaprisan - Predicted Percentage of Subjects Below 90% of the Maximum Probability of Induced Amenorrhea|The final exposure-response model was used to simulate the percentage of subjects below 90% of the maximum probability of induced amenorrhea (that is, all days with bleeding intensity 1 = none) for the selected doses 1, 2 and 3 mg (see table below).|From start of the study treatment to Day 84 (treatment period)||||Percentage of subjects|||Number
2603449|NCT02131662|Other Pre-specified|Steady-state Exposure Achieving Half-maximal Effect (EAUC50) of Induced Amenorrhea During Treatment Period of Vilaprisan|Area-under-the-curve (AUC) of vilaprisan between 0 and 24 hours post-dose at steady-state achieving 50% of maximum effect of vilaprisan on induced amenorrhea during treatment period. Induced amenorrhea was defined as number of subjects with induced-amenorrhea (that is, all days with bleeding intensity 1 = none) , i.e. no bleeding or spotting allowed after initial bleeding episode until end of treatment. The nature of this exposure response analysis was the development of a model valid for the exposure response relationship over the entire range of available exposures (i.e. across all dose groups). Therefore, observations (exposure - induced amenorrhea) of all subjects need to be combined.|From start of the study treatment to Day 84 (treatment period)|The exposure response analysis includes all verum treated subjects with valid PK concentration data and valid PD data and all placebo treated subjects with valid PD data (placebo: 50, 0.5 mg 50, 1.0 mg 56, 2.0 mg: 56, 4.0 mg: 55, in total 267).|||mcg*h/L||95% Confidence Interval|Number
2603450|NCT02131662|Other Pre-specified|Exposure-response Analysis of Vilaprisan - Percentage of Subjects Achieving Maximum Effect (Emax) of Induced Amenorrhea|Maximum effect of vilaprisan on induced amenorrhea during treatment period. Induced amenorrhea was defined as number of subjects with amenorrhea (that is, all days with bleeding intensity 1 = none) , i.e. no bleeding or spotting allowed after initial bleeding episode until end of treatment. The nature of this exposure response analysis was the development of a model valid for the exposure response relationship over the entire range of available exposures (i.e. across all dose groups). Therefore, observations (exposure - induced amenorrhea) of all subjects need to be combined.|From start of the study treatment to Day 84 (treatment period)|The exposure response analysis includes all verum treated subjects with valid PK concentration data and valid PD data and all placebo treated subjects with valid PD data (placebo: 50, 0.5 mg 50, 1.0 mg 56, 2.0 mg: 56, 4.0 mg: 55, in total 267).|||Percentage of subjects||95% Confidence Interval|Number
2603451|NCT02131662|Secondary|Change in Volume of Largest Fibroid Compared to Baseline Measured by MRI|Pelvic Magnetic resonance imagings (MRI), without contrast agents, were performed for volume measurements of the uterus and fibroids preferably using 1.5 Tesla scanners or higher. Images were sent to the imaging core laboratory for evaluation. Volume measurements of the uterus and fibroids were performed centrally by independent radiologist(s).|From baseline to end of follow-up period||||mL||Full Range|Median
2603452|NCT02131662|Secondary|Time to Onset of Controlled Bleeding|Onset of controlled bleeding was defined by the first day, for which the MBL (assessed by MP, Version 2014) for all subsequent 28-day periods up to the end of the treatment period was less than 80 mL. Kaplan-Meier estimated time to onset of controlled bleeding (days) was reported.|During treatment period||||Days||Inter-Quartile Range|Median
2623570|NCT01929460|Secondary|Adverse Drug Reactions|Number of participants with adverse drug reactions|six weeks||||participants|||Number
2603454|NCT02131662|Primary|Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment|Amenorrhea was defined as no scheduled or unscheduled bleeding/spotting after the end of the initial bleeding episode until end of treatment. Dose-response curve was estimated based on the primary endpoint. The 4 parameters characterizing the dose-response curve were reported in other pre-specified endpoints below.|After end of the initial bleeding episode until the end of treatment, up to 12 weeks||||Percentage of subjects|||Number
2603455|NCT02131636|Secondary|Percentage of Patients With at Least a 1-Grade Decrease From Baseline on the SSA 5-point Scale|The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 1 grade decrease (improvement) on the SSA from baseline at Day 1 hour 1. Baseline was defined as the measurement at predose on Day 1.|Baseline, Day 1 (Hour 1)|Intent-to-Treat: all randomized patients|||Percentage of Pateints|||Number
2603456|NCT02131636|Secondary|Change From Baseline on the SA-RFR Questionnaire Item #4|The SA-RFR questionnaire item 4 is completed by patients assessing how much their face burned due to facial redness on a 5 point scale (range 0=does not burn at all and 4=burns a lot). Patients were evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. A lower score change from baseline (negative number) indicates a decrease in facial redness (improvement), and a higher score change from baseline (positive number) indicates an increase in facial burning (worsening).|Baseline, Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
2603457|NCT02131636|Secondary|Percentage of Patients Reporting Treatment Satisfaction on the Satisfaction Assessment for Rosacea Facial Redness (SA-RFR) Questionnaire Item 9|"The SA-RFR questionnaire item 9 is completed by patients assessing treatment satisfaction on facial redness. Patients reporting treatment satisfaction as very satisfied or satisfied are noted. The percentage of patients was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29."|Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
2603458|NCT02131636|Secondary|Percent Change From Baseline in Rosacea Facial Redness as Measured by Digital Imaging Analysis (DIA)|Rosacea facial redness in the treatment area was measured by DIA. The percent change was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on Day 29. Baseline was defined as the measurement at predose on Day 1. A negative number change from baseline indicates a decrease in facial redness (improvement), and a positive number change from baseline indicates an increase in facial redness (worsening).|Baseline, Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients with data at the time point|||Percent Change||Standard Deviation|Mean
2603459|NCT02131636|Secondary|Percentage of Patients With at Least a 2-Grade Decrease From Baseline on the SSA 5-point Scale|The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.|Baseline, Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
2603460|NCT02131636|Primary|Percentage of Patients With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) 5-point Scales|The investigator assessed the patient's overall severity of erythema in the treatment area on the 5 point CEA scale (ranging from 0=clear skin with no signs of erythema to 4=severe erythema/fiery redness). The patient assessed the overall severity of rosacea facial redness in the treatment area on the 5 point SSA scale (ranging from 0=no signs of unwanted redness to 4=severe redness). The percentage of patients with at least a 2 grade decrease (improvement) on both CEA and SSA from baseline was evaluated over the 12-hour evaluation period (hours 3, 6, 9, and 12) postdose on day 29. Baseline was defined as the measurement at predose on Day 1.|Baseline, Day 29 (Hours 3, 6, 9, and 12)|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
2603461|NCT02131532|Primary|Feasibility of Follow-up Assessment at Three Months After the End of Treatment|Numbers of participants who completed and returned the questionnaires on time (as required) and of those who delayed the completion.|3 months after the end of treatment||||participants|||Number
2603462|NCT02131532|Primary|Feasibility of Telephone-delivered Booster Sessions|Numbers of participants who attended the booster session as planned and those who rearranged the session|3 months after the end of treatment||||participants|||Number
2603463|NCT02131532|Primary|Attendance of Treatment Sessions|Number of participants who completed all treatment sessions.|3 months after the end of treatment||||participants|||Number
2603464|NCT02131532|Primary|Feasibility of Recruitment Process|The numbers of stroke patients involved at each stage of recruitment were reported under this outcome.|3 months after the end of treatment||||participants|||Number
2603465|NCT02131532|Secondary|SIS - Social Activity|The social activity subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
2603466|NCT02131532|Secondary|SIS - Hand Function|The hand function subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
2603467|NCT02131532|Secondary|SIS - Mobility|The mobility subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
2603468|NCT02131532|Secondary|SIS - Daily Activities|The daily activities subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
2603469|NCT02131532|Secondary|SIS - Communication|The communication subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
2603470|NCT02131532|Secondary|SIS - Emotion|The emotion subscale of the Stroke Impact Scale 3.0, of which the score ranges from 0 to 100, with higher scores indicating better outcomes.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
2603474|NCT02131532|Secondary|Nottingham Extended Activities of Daily Living (NEADL)|The total NEADL score ranges from 0 to 22, with higher scores indicating better outcomes of independence.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
2603475|NCT02131532|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The total PHQ-9 score ranges from 0 to 27, with higher scores indicating worse outcomes of depressive symptoms.|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
2603476|NCT02131532|Secondary|Fatigue Assessment Scale (FAS)|"This is the primary clinical outcome for this intervention (but clinical outcomes are all secondary outcomes for this pilot feasibility study).~The total FAS score ranges from 10 to 50, with higher scores indicating worse outcomes of fatigue severity."|3 months after the end of treatment||||units on a scale||Standard Deviation|Mean
2603477|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Methafilcon A|Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #3. LogMAR Visual Acuity (VA) to nearest letter)|1 hour post settling||||LogMAR||Standard Deviation|Mean
2603478|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Ocufilcon D|Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #2. LogMAR Visual Acuity (VA) to nearest letter)|1 hour post settling||||LogMAR||Standard Deviation|Mean
2603479|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Omafilcon A|Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs Pair #1. LogMAR Visual Acuity (VA) to nearest letter)|1 hour post settling||||LogMAR||Standard Deviation|Mean
2603480|NCT02131402|Primary|Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A|Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0= no sensation of stinging/burning,100= extreme stinging).|1 hour post settling||||units on a scale||Standard Deviation|Mean
2603481|NCT02131402|Primary|Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D|Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100,0= no sensation of stinging/burning, 100= extreme stinging).|1 hour post settling||||units on a scale||Standard Deviation|Mean
2603482|NCT02131402|Primary|Participants Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A|Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging).|1 hour post settling||||units on a scale||Standard Deviation|Mean
2603483|NCT02131402|Primary|Participant Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A|Surveyed after insertion of each lens for Pair #3. Rated by questionnaires (0-100,0=no sensation of stinging/burning, 100=extreme stinging).|Baseline||||units on a scale||Standard Deviation|Mean
2603484|NCT02131402|Primary|Participant Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D|Surveyed after insertion of each lens Pair #2 at baseline. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging)|Baseline||||units on a scale||Standard Deviation|Mean
2603485|NCT02131402|Primary|Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A|Surveyed after insertion of each lens for Pair #1 at baseline visit. Rated by questionnaires (0-100, 0=no sensation of stinging/burning, 100= extreme stinging).|Baseline||||units on a scale||Standard Deviation|Mean
2603486|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A|Assessed after 1 hour post settling for Pair #3, (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)|1 hour post settling||||percentage of eyes|Eyes||Number
2603487|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D|Assessed after 1 hour post settling for Pair #2. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)|1 hour post settling||||percentage of eyes|Eyes||Number
2603488|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A|Assessed after 1 hour post settling of lens wear for Pair #1. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable).|1 hour post settling||||percentage of eyes|Eyes||Number
2603489|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Methafilcon A|Assessed after 1 hour post settling for Pair #3. (Scale 0%-100%, 0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support)|1 hour post settling||||units on a scale||Standard Deviation|Mean
2603490|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Ocufilcon D|Assessed after 1 hour post settling for Pair #2, (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support).|1 hour post settling||||units on a scale||Standard Deviation|Mean
2603491|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Omafilcon A|Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp. (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support).|1 hour post settling||||units on a scale||Standard Deviation|Mean
2603492|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Methafilcon A|Assessed after 1 hour post settling for Pair #3. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|1 hour post settling||||units on a scale||Standard Deviation|Mean
2603493|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Ocufilcon D|Assessed after 1 hour post settling for Pair #2. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|1 hour post settling||||units on a scale||Standard Deviation|Mean
2603494|NCT02131402|Primary|Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Omafilcon A|Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|1 hour post settling||||units on a scale||Standard Deviation|Mean
2603495|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A|Surveyed after 1 hour post settling for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).|1 hour post settling||||percentage of subjects|||Number
2603496|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D|Surveyed after 1 hour post settling for Pair #2. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).|1 hour post settling||||percentage of subjects|||Number
2603497|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A|Surveyed after 1 hour post settling (1 hour) of lens wear for Pair #1. Rated by subjects preference for test lens or control lens (Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).|1 hour post settling||||percentage of subjects|||Number
2603498|NCT02131402|Primary|Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A|Surveyed after insertion of each lens for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).|Baseline||||percentage of eyes|||Number
2603499|NCT02131402|Primary|Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D|Surveyed at insertion of each lens Pair #2 by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).|Baseline||||percentage of subjects|||Number
2603500|NCT02131402|Primary|Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A|Surveyed after insertion of each lens Pair #1 at (Baseline visit). Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).|Baseline||||percentage of subjects|||Number
2603501|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A|Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0=Can't be worn and causes pain 100= can't feel).|1 hours post settling||||units on a scale||Standard Deviation|Mean
2603502|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D|Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100 0=Can't be worn and causes pain, 100= can't feel).|1 hour post settling||||units on a scale||Standard Deviation|Mean
2603503|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A|Surveyed after 1 hour post settling for Pair #1. Rated by questionnaires (0-100, 0= Can't be worn and causes pain, 100= can't feel).|1 hour post settling||||units on a scale||Standard Deviation|Mean
2603504|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A|Surveyed after insertion Pair #3 (baseline). Rated by questionnaires (0-100, 0-Can't be worn, 100= can't feel).|Baseline||||units on a scale||Standard Deviation|Mean
2603505|NCT02131402|Primary|Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A|Surveyed after insertion of each lens at baseline visit for Pair #1. Rated by questionnaires (0-100, 0-Can't be worn and causes pain,100= can't feel).|Baseline||||units on a scale||Standard Deviation|Mean
2603506|NCT02131402|Primary|Participants Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D|Surveyed after insertion of each lens Pair #2 (at insertion). Rated by Questionnaire (0-100,0=Can't be worn and causes pain, 100=can't feel).|Baseline||||units on a scale||Standard Deviation|Mean
2603507|NCT02131402|Primary|Participant's Subjective Rating for Lens Handling - Enfilcon A / Methafilcon A|Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3. Rated by questionnaires (0-100 0=Very difficult, 100= very easy).|1 hour post settling||||units on a scale||Standard Deviation|Mean
2603508|NCT02131402|Primary|Participant's Subjective Rating for Lens Handling - Enfilcon A / Ocufilcon D|Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2 (1 hour). Rated by questionnaires (0=Very difficult 0-100, 100= very easy).|1 hour post settling||||units on a scale||Standard Deviation|Mean
2603509|NCT02131402|Primary|Participant's Subjective Rating for Lens Handling - Enfilcon A / Omafilcon A|Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1 (1 hour). Rated by questionnaires (0= Very difficult 0-100, 100= very easy).|1 hour post settling||||units on a scale||Standard Deviation|Mean
2603510|NCT02131324|Primary|The Percentage of Subjects With HPA Axis Suppression.|HPA axis suppression as measured by serum cortisol levels post cosyntropin test (ACTH test)|Day 15|All summaries and analyses were performed on the safety population. All subjects who received at least one confirmed dose of study product and provided any post-baseline safety information were included in the safety population. No imputation was made for missing safety data.|||percentage of participants|||Number
2603511|NCT02131311|Secondary|Percentage of Responders for Pad Weight Gain or SUI Episodes||from the 14-day baseline period to the first 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"|||percentage of subjects|||Number
2603512|NCT02131311|Secondary|Change in Pad Weight Gain|change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the first 7 days of a 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"|||grams/usage period||Inter-Quartile Range|Median
2603513|NCT02131311|Secondary|Change in Stress Urinary Incontinence Episodes|change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the first 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"|||number of episodes/usage period||Inter-Quartile Range|Median
2603720|NCT02130024|Secondary|Mean Number of Intravitreal Injections From Baseline to Month 12 and to Month 24|The number of intravitreal injections was calculated. One eye (study eye) contributed to the analysis.|Baseline, Month 12, Month 24|FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.|||injections||Standard Deviation|Mean
2603514|NCT02131311|Secondary|Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)|The IIQ-7 is based on 7 questions referring to areas which may have been influenced or changed by accidental urine loss and/or prolapse. These questions are assigned a value of, 0 = 'Not at all,' 1= 'Slightly,' 2 = 'Moderately,' or 3 'Greatly.' The IIQ-7 is scored by taking the average score of items and then multiplying the average by 33 1/3 to put scores on a scale from 0 to 100. A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction in scores from baseline reflects improved quality of life.|baseline and end-of-treatment|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data at end of treatment"|||units on a scale||Inter-Quartile Range|Median
2603515|NCT02131311|Secondary|Change in Pad Weight Gain|change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"|||grams/usage period||Inter-Quartile Range|Median
2603516|NCT02131311|Secondary|Change in Stress Urinary Incontinence Episodes|change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"|||episodes/usage period||Inter-Quartile Range|Median
2603517|NCT02131311|Primary|Percentage of Responders for Pad Weight Gain or SUI Episodes||from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"|||percentage of subjects|||Number
2603518|NCT02131272|Secondary|Incidence of Adverse Events (AEs)|The total number of treatment emergent adverse events (the onset of the adverse event is on or after the first day of trial product administration, and no later than 7 days after the last day of trial product administration) reported during the 26 weeks of treatment.|weeks 0 - 26|Safety analysis set included all subjects receiving at least one dose of randomised treatment.|||Number of events|||Number
2603519|NCT02131272|Secondary|Total Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes|Total number of treatment emergent severe (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose confirmed symptomatic hypoglycaemic episodes (plasma glucose value <3.1 mmol/L [56 mg/dL] with symptoms consistent with hypoglycaemia) experienced by the subjects during the trial.|Weeks 0 - 26|Safety analysis set included all subjects receiving at least one dose of randomised treatment.|||Number of episodes|||Number
2603520|NCT02131272|Secondary|Total Number of Treatment Emergent Nocturnal (23:00-06:59) Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes|The total number of blood glucose confirmed symptomatic nocturnal (time of onset between 23:00 and 06.59 both inclusive) severe (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or blood glucose confirmed symptomatic hypoglycaemic episodes (plasma glucose value <3.1 mmol/L [56 mg/dL] with symptoms consistent with hypoglycaemia) experienced by the subjects during the trial.|Weeks 0 - 26|Safety analysis set included all subjects receiving at least one dose of randomised treatment.|||Number of episodes|||Number
2603521|NCT02131272|Secondary|Proportion of Subjects Achieving HbA1c Below 7.5%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment|Proportion of subjects achieving HbA1c below 7.5% is presented as percentage of subjects achieving HbA1c <7.5%, who have not experienced any treatment emergent severe hypoglycaemic episodes (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) within the last 14 weeks of treatment.|At week 26|Full analysis set included all the randomised subjects. Only subjects who have been exposed for a minimum of 14 weeks contributed to the analysis (20 subjects in the Insulin detemir + metformin + diet/exercise arm and 21 subjects in the Insulin NPH + metformin + diet/exercise arm).|||Percentage of subjects|||Number
2603522|NCT02131272|Secondary|Proportion of Subjects Achieving HbA1c Below 7.0%, Who Have Not Experienced Any Treatment Emergent Severe Hypoglycaemic Episodes Within the Last 14 Weeks of Treatment.|Proportion of subjects achieving HbA1c <7.0% is presented as percentage of subjects achieving HbA1c <7.0%, who have not experienced any treatment emergent severe hypoglycaemic episodes (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) within the last 14 weeks of treatment.|At week 26|Full analysis set included all the randomised subjects. Only subjects who have been exposed for a minimum of 14 weeks contributed to the analysis (20 subjects in the Insulin detemir + metformin + diet/exercise arm and 21 subjects in the Insulin NPH + metformin + diet/exercise arm).|||Percentage of subjects|||Number
2603523|NCT02131272|Secondary|Change in Body Weight Standard Deviation Score (SDS)|Change in body weight standard deviation score (SDS) from baseline to week 26. In order to reduce the variability in body weight measurements, SDS were calculated. SDS for weight was derived by comparing the actual measurements with standard growth charts for the United States. Standard values provided by the standard growth charts according to the subject's sex and age at the time of the measurement were used to calculate the SDS.|week 0, week 26|Full analysis set included all the randomised subjects.|||standard deviation score||Standard Deviation|Mean
2603524|NCT02131272|Primary|Change in HbA1c (Glycosylated Haemoglobin)|Estimated mean change in HbA1c (glycosylated haemoglobin) from baseline to week 26.|week 0, week 26|Full analysis set included all the randomised subjects.|||Percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
2603562|NCT02131064|Secondary|Maximum Observed Serum Concentration (Cmax) of Trastuzumab|Only participants who received trastuzumab were to be analyzed for this outcome.|15-30 minutes (min) post-study treatment infusion (infusion duration = 90 min) on Day 1 of Cycle 1 and 6 (each cycle = 21 days) in neoadjuvant and adjuvant period|The pharmacokinetic population comprised all patients who received at least one treatment dose of trastuzumab emtansine (for patients in the T-DM1 + P arm) or trastuzumab (for patients in the TCH + P arm), and had at least one post-treatment serum or plasma sample.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
2603750|NCT02129608|Primary|Change in Weight|The change in weight from baseline to 3 months|3 months||||kg||Standard Deviation|Mean
2603525|NCT02131259|Secondary|Objective Overall Response Based on Physician's Assessment [According to RECIST Version 1.1]|"Objective overall response based on investigator's assessment (according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for target lesions and assessed by MRI: complete response (CR) is the disappearance of all target lesions, a partial response (PR) is defined as at least a 30% decrease in the sum of the target lesion and stable disease (SD) is defined as fitting the criteria neither for progressive disease (PD) nor a PR. The population included the Tyrosine Kinase Inhibitor [TKI]-naïve patients and the TKI pre-treated patients.~Overall response was calculated with 95% Clopper-Pearson confidence interval.~OR = (CR+PR)/(CR+PR+SD+PD+Unknown)*100."|52 weeks.|Efficacy Set: This analysis set was a subset of the safety set, which included all patients in the safety set except those who had no available tumour assessment and/or who did not suffer from Epidermal Growth Factor Receptor (EGFR) mutation-positive inoperable or recurrent Non-Small Cell Lung Cancer (NSCLC).|||Percentage of participants||95% Confidence Interval|Number
2603526|NCT02131259|Primary|Incidence of Adverse Drug Reactions (ADRs)|"This outcome measure presents incidence of adverse drug reactions (ADRs). An ADR was defined as an AE if either the investigator or the sponsor (or both) assessed the causal relationship to GIOTRIF® Tablets either as Yes, Probably yes or Can't be denied.~The number of patients with Adverse Drug Reactions (ADRs): Malignant progression reported as ADRs were included."|From first drug administration until 28 days after the last drug administration, up to 52 weeks.|Safety Set: This analysis set included all patients who had received treatment of GIOTRIF® tablets except those who were found not following registration rules, invalid contract or previous treatment experience with GIOTRIF® tablets.|||Percentage of Participants|||Number
2603527|NCT02131233|Secondary|Percentage of Participants Who Discontinued From Drug Therapy Due to an AE up to Week 96|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE|Up to Week 96|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2603528|NCT02131233|Secondary|Percentage of Participants Who Discontinued From Drug Therapy Due to an AE at Week 48|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE|Up to Week 48|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2603529|NCT02131233|Secondary|Percentage of Participants With a Serious and Drug-Related AE After 96 Weeks of Treatment|A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. An investigator who is a qualified physician evaluated whether or not a SAE is drug-related.|Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2603530|NCT02131233|Secondary|Percentage of Participants With a Serious and Drug-Related AE at Week 48|A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event. An investigator who is a qualified physician evaluated whether or not a SAE is drug-related.|Up to Week 48|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2603531|NCT02131233|Secondary|Percentage of Participants With a SAE After 96 Weeks of Treatment|A SAE is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.|Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2603532|NCT02131233|Secondary|Percentage of Participants With a Serious Adverse Event (SAE) at Week 48|A serious adverse event (SAE) is any AE occurring at any dose or during any use of Sponsor's product that does the following: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.|Up to Week 48|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2603533|NCT02131233|Secondary|Percentage of Participants With a Drug-Related AE After 96 Weeks of Treatment|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. An investigator who is a qualified physician evaluated whether or not an AE was drug-related.|Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2603534|NCT02131233|Secondary|Percentage of Participants With a Drug-Related AE at Week 48|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. An investigator who is a qualified physician evaluated whether or not an AE was drug-related.|Up to Week 48|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2603535|NCT02131233|Secondary|Percentage of Participants With an AE After 96 Weeks of Treatment|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to Week 98 (96 weeks of treatment + 2 weeks of follow up)|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2603536|NCT02131233|Secondary|Percentage of Participants With an Adverse Event (AE) at Week 48|An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to Week 48|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2603537|NCT02131233|Secondary|Change From Baseline in CD4 Cell Count at Week 96|CD4 cells were counted from blood collected at baseline and week 96, and the change from baseline determined from week 96 minus baseline values.|Baseline and Week 96|All randomized participants who received at least one dose of study treatment and have baseline data. The Observed Failure (OF) approach to handling missing values assumed baseline-carry-forward for all failures, and excluded other missing values.|||cells/mm^3||95% Confidence Interval|Mean
2603538|NCT02131233|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 48|CD4 cells were counted from blood collected at baseline and week 48, and the change from baseline determined from week 48 minus baseline values.|Baseline and Week 48|All randomized participants who received at least one dose of study treatment and have baseline data. The Observed Failure (OF) approach to handling missing values assumed baseline-carry-forward for all failures, and excluded other missing values.|||cells/mm^3||95% Confidence Interval|Mean
2603539|NCT02131233|Secondary|Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 96|"From blood samples collected at week 96, HIV-1 RNA levels were determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL. The NC=F approach as defined by FDA snapshot approach was used as the primary approach to analysis where all missing data were treated as failures regardless of the reason."|Week 96|All randomized participants who received at least one dose of study treatment|||Percentage of participants|||Number
2603540|NCT02131233|Primary|Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 48|"From blood samples collected at week 48, HIV-1 RNA levels were determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL. The NC=F approach as defined by FDA snapshot approach was used as the primary approach to analysis where all missing data were treated as failures regardless of the reason."|Week 48|All randomized participants who received at least one dose of study treatment|||Percentage of participants||95% Confidence Interval|Number
2603541|NCT02131155|Secondary|Health Related Quality of Life (HRQOL)|"The main analysis of HRQOL questionnaires was to focus on the change in score from baseline in the following scales measured on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 and EORTC QLQ-H&N35:~Global Health Status/ Quality of Life (QOL) Scale~Pain Scale~Swallowing Scale"|up to 4 years|Randomised Set; This study was early terminated and data was available for less than 2/3rds of participants hence per internal Boehringer Ingelheim rules the analysis was not performed as planned in protocol.||||||
2603542|NCT02131155|Secondary|Overall Survival (OS)|"OS was defined as time from the date of randomisation until death.~For patients with known date of death (regardless of the cause of death):~OS [days] = date of death - date of randomisation +1~For patients known to be alive by the end of trial:~OS (censored) [days] = the last date when the patient was known to be alive - date of randomisation +1 OS was to be analysed similarly to DFS."|up to 4 years|Randomised Set; This study was early terminated and data was available for less than 2/3rds of participants hence per internal Boehringer Ingelheim rules the analysis was not performed as planned in protocol.||||||
2603543|NCT02131155|Secondary|Disease Free Survival (DFS) Rate at 2 Years|Disease Free Survival (DFS) rate at 2 years is presented|up to 2 years|Randomised Set; This study was early terminated and data was available for less than 2/3rds of participants hence per internal Boehringer Ingelheim rules the analysis was not performed as planned in protocol.||||||
2603587|NCT02130765|Primary|Number of Subjects Who Experienced a Select Serious Adverse Event|Primary Safety Endpoint: Number of subjects who experience a select serious adverse events within the 30 day follow up. Those events are anticipated, associated with catheter ablation, and are cardiovascular, pulmonary, or peripheral vascular in nature, as listed in the Primary Safety Events List.|30 days|4 subjects randomized to treatment arm but did not receive ablation (not treated) and therefore excluded from analysis.|||Participants|||Count of Participants
2603544|NCT02131155|Primary|Disease Free Survival (DFS)|"DFS, defined as the number of days from the date of randomisation to the date of tumour recurrence/ Second Primary Tumours (SPT) or death from any cause, whichever occurred first.~For patients with known date of tumour recurrence/SPT (or death), the event date was the date of tumour recurrence/SPT or the date of death, whichever came first, i.e.~DFS [day] = minimum (date of tumour recurrence/SPT, date of death) - date of randomisation +1.~For patients known to be alive and without tumour recurrence/SPT by the end of trial or follow-up visit, they were censored at the date of last imaging when the patient was known to be disease-free and alive:~DFS (censored) [days] = date of last imaging when the patient was known to be diseasefree and alive - date of randomisation + 1. The Kaplan-Meier (KM) method was to be used to estimate the median DFS for each treatment group. 95% confidence interval (CI) was to be constructed using the Greenwood variance estimate."|up to 4 years|Randomised Set; This study was early terminated and data was available for less than 2/3rds of participants hence per internal Boehringer Ingelheim rules the analysis was not performed as planned in protocol.||||||
2603545|NCT02131129|Secondary|Negative Symptoms|"rTMS effectiveness in reducing negative symptoms as measured by the negative symptom assessment scale (NSA-16). The NSA-16 is used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale rates subjects on 16 anchors, is a semi-structured, clinical interview, and each item is rated from 1 to 6. The total score is the sum of the 16 specific items and ranges from 16 to 96; a higher score indicates greater severity of illness. In addition, there is a global rating that represents the overall assessment of a subject's negative symptoms. The rating should not be an average of any particular behavior, but a gestalt of everything observed in the interview."|Assessed at Baseline (day 0), Midpoint (day 8), and Endpoint (day 15)||||NSA-16 Scores||Standard Deviation|Mean
2603546|NCT02131129|Secondary|Symptoms|rTMS effectiveness in general symptomatology assessed by the Positive and Negative Syndrome Scale (PANSS). The PANSS is a semi-structured interview, containing 30 items that assess symptoms of psychotic disorders including positive, negative, and general psychopathology symptoms. Positive symptoms are rated on 7 items, negative symptoms are rated on 7 items, and general psychopathology on 16 items. Scores for each item range from 1=absent to 7=extreme. Positive, negative, and general psychopathology symptoms can each respectively render total scores. Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psychopathology scores ranging from 16-112. When all items are summed together a total score is generated. Total scores for all items range from 30-210, a lower score reflecting fewer symptoms.|For within-group comparisons, scores at V13 (day 15) and V14 (follow-up two weeks after V13) were compared to baseline||||Change Scores Relative to Baseline||Standard Error|Least Squares Mean
2603547|NCT02131129|Secondary|Cognitive Performance|rTMS effectiveness in improving cognitive performance as measured by the Brief Assessment of Cognition in Schizophrenia (BACS) composite score. The BACS is a battery specifically designed to measure treatment-related changes in cognition by utilizing 6 tasks, and has alternate forms, thus minimizing practice effects. Each task generates a raw score (with a higher score indicating better performance): verbal memory 0-75; digit sequencing 0-28; token motor task 0-100; semantic&letter fluency 0-148; symbol coding 0-110; and tower of London 0-22. The raw scores are used to generate a composite score that is calculated by summing t-scores derived by comparisons with a normative sample of 404 healthy controls. The six brief assessments' t-scores, are summed, and averaged to provide a composite t-score. The composite score min and max are between -43 and 100. A higher score indicating better cognitive performance.|14 days||||BACS Sub-scale Scores||Standard Error|Least Squares Mean
2603548|NCT02131129|Secondary|Cognitive Performance|rTMS effectiveness in improving cognitive performance was assessed by the Trail Making Test-Part B change score and performance on the Trail Making Test-Part B. The Trail Making Test-Part B is a measure of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive targets on a sheet of paper. In Part B version the subject alternates between numbers and letters (1, A, 2, B, etc.) The goal of the test is for the subject is to finish part B as quickly as possible, the time taken to complete the test is used as the primary performance metric.|14 days||||seconds||Standard Error|Least Squares Mean
2603549|NCT02131129|Primary|Cortical Activation|effects of rTMS on cortical activation using fMRI during working memory and episodic memory tasks|Change from Baseline (day 1) to Visit 13 (day 15)||||Bold signal change||Standard Deviation|Mean
2603550|NCT02131129|Primary|Cognitive Performance|rTMS effectiveness in improving cognitive performance as measured by the Brief Assessment of Cognition in Schizophrenia (BACS) composite score. The BACS is a battery specifically designed to measure treatment-related changes in cognition, and has alternate forms, thus minimizing practice effects. The battery includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed, and generates a composite score that is calculated by summing t-scores derived by comparisons with a normative sample of 404 healthy controls. The six brief assessments' t-scores, are summed, and averaged to provide a composite t-score. The composite score min and max are between -43 and 100. A higher score indicating better cognitive performance. The composite score is reported as a change score relative to baseline for both.|For within-group comparisons, scores at V13 (day 15) and V14 (follow-up two weeks after V13) were compared to baseline||||BACS Composite Score||Standard Error|Least Squares Mean
2603551|NCT02131064|Secondary|Percentage of Participants With a Clinically Meaningful Increase in Symptom Subscales|Participants rated their symptoms on EORTC QLQ C-30 and mQLQ-BR23, with total scores ranging from 0 (worst) to 100 (best); where higher score indicates greater degree of symptoms. Clinically meaningful increase in symptoms was defined as an increase in score (deterioration) of 11 points in nausea and vomiting, pain, dyspnea; increase of 9 points in insomnia; increase of 14 points in appetite loss; increase of 15 points in diarrhea, constipation; increase of 10 points in fatigue, systemic therapy side effects, hair loss.|From Baseline (Day 1 Cycle 1) to Cycle 6 (each cycle = 21 days) in neoadjuvant period|The Intent-to-treat (ITT) Population comprised all randomized participants, whether or not they received any study treatment or completed a full course of study treatment. Participants were analyzed according to their randomized treatment. As per protocol, the analysis for this outcome measure was focused on the neoadjuvant period only.|||Percentage of Participants|||Number
2603588|NCT02130765|Primary|Number of Subjects Who Experienced an ICD Shock Event.|Primary Effectiveness endpoint: Number reported is number of subjects who experienced an ICD shock event (including both appropriate and inappropriate) through 12 month follow up|12 months||||Participants|||Count of Participants
2603552|NCT02131064|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to TDM-1|Participants were considered post-baseline ATA positive if they had ATAs post-baseline that were either treatment-induced or treatment-enhanced. Participants had treatment-induced ATAs if they had a negative or missing ATA result at baseline, and at least one positive ATA result post-baseline. Participants had treatment-enhanced ATAs if they had a positive ATA result at baseline, and at least one positive ATA result post-baseline that was greater than or equal to (>/=) 0.60 titer units higher than the result at baseline.|Baseline (b) (Pre-TDM1 [0 hr] infusion [infusion duration = 90 min] on Day 1 of Cycle 1); post-baseline (pb) (Pre-TDM1 infusion [0 hr] on Day 1 of Cycle 6) (each cycle = 21 days) in neoadjuvant and adjuvant period|The participants included in this analysis were the participants who received at least one dose of trastuzumab emtansine and had at least one reported serum or plasma results.|||Percentage of Participants|||Number
2603553|NCT02131064|Secondary|Percentage of Participants With a Clinically Meaningful Deterioration in Function Subscales|Participants rated their function on EORTC QLQ C-30, with total score and single-item (physical, cognitive and role functioning) scores ranging from 0 (worst) to 100 (best); where higher score indicates better functioning. Clinically meaningful deterioration was defined as a decrease in score of 10 points in physical function; decrease of 7 points in cognitive function and decrease of 14 points in role function.|From Baseline (Day 1 Cycle 1) to Cycle 6 (each cycle = 21 days) in neoadjuvant period|The Intent-to-treat (ITT) Population comprised all randomized participants, whether or not they received any study treatment or completed a full course of study treatment. Participants were analyzed according to their randomized treatment. As per protocol, the analysis for this outcome measure was focused on the neoadjuvant period only.|||Percentage of Participants|||Number
2603554|NCT02131064|Secondary|Percentage of Participants With Selected Adverse Events (AEs)|Selected AEs included hepatotoxicity, pulmonary toxicity, cardiac dysfunction, neutropenia, thrombocytopenia, peripheral neuropathy, hemorrhage, infusion related reaction (IRR)/hypersensitivity, IRR/Hypersensitivity symptoms, rash, diarrhea and mucositis. An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.|Baseline to end of study (approximately 47 months)|The Safety Population comprised all patients who received at least one full or partial dose of any study treatment. Patients were analyzed according to the treatment they actually received.|||Percentage of Participants|||Number
2603555|NCT02131064|Secondary|Percentage of Participants by Response for Hair Loss Single Item|"Participants answered the Question Have you lost any hair?, from the mQLQ-BR23, on a 5-point scale (1 'Not at all', 2 'A little', 3 'Somewhat', 4 'Quite a bit', 5 'Very much'). Percentage of participants by each response was reported."|Baseline,Cycle(C) 3, C5 of neoadjuvant period (each C=21 days); pre-surgery visit (within 6weeks after neoadjuvant therapy; up to approx 6months), C4 & 8 of Adjuvant Period (each C=21 days), End of Treatment, Follow up 2 & 4(approx 47 months)|ITT population of patients with both a baseline assessment and at least one post-treatment assessment in the respective single question are included in the analysis.|||Percentage of Participants|||Number
2603556|NCT02131064|Secondary|Percentage of Participants With ATA to Trastuzumab||Baseline (Pre-trastuzumab [0 hr] infusion [infusion duration = 90 min] on Day 1 of Cycle 1); post-baseline (Pre-trastuzumab infusion [0 hr] on Day 1 of Cycle 6) (each cycle = 21 days) in neoadjuvant and adjuvant period|The participants included in this analysis were the participants who received at least one dose of trastuzumab and had at least one reported serum or plasma results.|||Percentage of participants|||Number
2603557|NCT02131064|Secondary|Serum Levels of Plasma DM1-Containing Catabolites Concentrations (in ng/mL) (Nonreducible Thioether Linker [MCC]-DM1 and Lysine [Lys]-MCC-DM1)||15-30 min post-study treatment infusion (Cmax) on Day 1 of Cycle 1 and 6 in neoadjuvant and adjuvant period|The pharmacokinetic population comprised all patients who received at least one treatment dose of trastuzumab emtansine (for patients in the T-DM1 + P arm) or trastuzumab (for patients in the TCH + P arm), and had at least one post-treatment serum or plasma sample.|||ng/mL||Standard Deviation|Mean
2603558|NCT02131064|Secondary|Plasma N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1) Concentrations|DM1 is the metabolite of trastuzumab emtansine. Only participants who received trastuzumab emtansine were to be analyzed for this outcome.|15-30 min post-study treatment infusion (Cmax) on Day 1 of Cycle 1 and 6 in neoadjuvant and adjuvant period|The pharmacokinetic population comprised all patients who received at least one treatment dose of trastuzumab emtansine (for patients in the T-DM1 + P arm) or trastuzumab (for patients in the TCH + P arm), and had at least one post-treatment serum or plasma sample.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2603559|NCT02131064|Secondary|Cmin of Trastuzumab Emtansine and Total Trastuzumab|Only participants who received trastuzumab emtansine were to be analyzed for this outcome.|Pre-study treatment infusion (0 hr) (infusion duration = 90 min) on Day 1 of Cycle 6 (cycle length = 21 days) in neoadjuvant and adjuvant period|The pharmacokinetic population comprised all patients who received at least one treatment dose of trastuzumab emtansine (for patients in the T-DM1 + P arm) or trastuzumab (for patients in the TCH + P arm), and had at least one post-treatment serum or plasma sample.|||mcg/mL||Standard Deviation|Mean
2603560|NCT02131064|Secondary|Minimum Observed Serum Concentration (Cmin) of Trastuzumab|Only participants who received trastuzumab were to be analyzed for this outcome.|Pre-study treatment infusion (0 hours [hr]) (infusion duration = 90 min) on Day 1 of Cycle 6 (cycle length = 21 days) in neoadjuvant and adjuvant period|The pharmacokinetic population comprised all patients who received at least one treatment dose of trastuzumab emtansine (for patients in the T-DM1 + P arm) or trastuzumab (for patients in the TCH + P arm), and had at least one post-treatment serum or plasma sample.|||mcg/mL||Standard Deviation|Mean
2603561|NCT02131064|Secondary|Cmax of Trastuzumab Emtansine and Total Trastuzumab|Only participants who received trastuzumab emtansine were to be analyzed for this outcome.|15-30 min post-study treatment infusion (infusion duration = 90 min) on Day 1 of Cycle 1 and 6 (each cycle = 21 days) in neoadjuvant and adjuvant period.|The pharmacokinetic population comprised all patients who received at least one treatment dose of trastuzumab emtansine (for patients in the T-DM1 + P arm) or trastuzumab (for patients in the TCH + P arm), and had at least one post-treatment serum or plasma sample.|||mcg/mL||Standard Deviation|Mean
2603751|NCT02129608|Primary|Change in Waist Circumference|The change in waist circumference from baseline to 3 months|3 months||||cm||Standard Deviation|Mean
2603563|NCT02131064|Secondary|Time to Clinically Meaningful Deterioration in Function Subscale|Participants rated their function on EORTC QLQ C-30, with total scores ranging from 0 (worst) to 100 (best); where higher score indicates better functioning. Time to deterioration was defined as the time from baseline to first 10-point (or greater) decrease as measured by physical function; to first 14-point (or greater) decrease as measured by role function, to first 7-point (or greater) decrease as measured by cognitive function. Median time to deterioration was estimated with Kaplan-Meier method. The 95% CI for the median was computed using the method of Brookmeyer and Crowley.|From Baseline (Day 1 Cycle 1) to Cycle 6 (each cycle = 21 days) in neoadjuvant period|Patients of the ITT population with a baseline assessment and at least one post-treatment assessment was included in this analysis.|||months||95% Confidence Interval|Median
2603564|NCT02131064|Secondary|Time to Clinically Meaningful Deterioration in GHS/QoL Score|Participants rated their quality of life (global health status) on EORTC QLQ C-30, with total scores ranging from 0 (worst) to 100 (best); where higher score indicates better quality of life. Time to deterioration was defined as the time from baseline to first 10-point (or greater) decrease as measured by GHS/QoL. All valid GHS/QoL questionnaires of the neoadjuvant phase including surgery were used. Participants without deterioration were censored at the time of completing the last GHS/QoL plus 1 day. Median time to deterioration was estimated with Kaplan-Meier method. The 95% confidence interval (CI) for the median was computed using the method of Brookmeyer and Crowley.|From Baseline (Day 1 Cycle 1) to Cycle 6 (each cycle = 21 days) in neoadjuvant period|The Intent-to-treat (ITT) Population comprised all randomized participants, whether or not they received any study treatment or completed a full course of study treatment. Participants were analyzed according to their randomized treatment. As per protocol, the analysis for this outcome measure was focused on the neoadjuvant period only.|||months||95% Confidence Interval|Median
2603565|NCT02131064|Secondary|Percentage of Participants With a Clinically Meaningful Deterioration in Global Health Status (GHS)/Quality of Life (QoL) Score|Participants rated their quality of life (global health status) on European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ- C30), with total scores ranging from 0 (worst) to 100 (best); where higher score indicates better quality of life. Clinically meaningful deterioration in GHS/QoL was defined as a decrease in score of 10 points in GHS/QoL.|From Baseline (Day 1 Cycle 1) to Cycle 6 (each cycle = 21 days) in neoadjuvant period|The Intent-to-treat (ITT) Population comprised all randomized participants, whether or not they received any study treatment or completed a full course of study treatment. Participants were analyzed according to their randomized treatment. As per protocol, the analysis for this outcome measure was focused on the neoadjuvant period only.|||Percentage of Participants|||Number
2603566|NCT02131064|Secondary|Percentage of Participants by Response for Skin Problem Single Items|"Participants answered the Question 1 Did itching skin bother you? and Question 2 Have you had skin problems?, from the mQLQ-BR23, on a 5-point scale (1 'Not at all', 2 'A little', 3 'Somewhat', 4 'Quite a bit', 5 'Very much'). Percentage of participants by each response was reported."|Baseline,Cycle(C) 3,C5 of neoadjuvant period (each C=21 days); pre-surgery visit (within 6weeks after neoadjuvant therapy; up to approx 6months), C4 & 8 of Adjuvant Period (each C=21 days), End of Treatment, Follow up 2 & 4 (approx 47 months)|ITT population of patients with both a baseline assessment and at least one post-treatment assessment in the respective single question are included in the analysis.|||Percentage of Participants|||Number
2603567|NCT02131064|Secondary|Percentage of Participants by Response for Neuropathy Single Item|"Participants answered the question Did you have tingling hands/feet?, from the Modified Quality of Life Questionnaire Breast Cancer 23 (mQLQ-BR23), on a 5-point scale (1 'Not at all', 2 'A little', 3 'Somewhat', 4 'Quite a bit', 5 'Very much'). Percentage of participants by each response was reported."|Baseline,Cycle(C) 3,C5 of neoadjuvant period (each C=21 days); pre-surgery visit (within 6weeks after neoadjuvant therapy; up to approx 6months), C4 & 8 of Adjuvant Period (each C=21 days), End of Treatment, Follow up 2 & 4 (approx 47 months)|ITT population of patients with both a baseline assessment and at least one post-treatment assessment in the respective single question are included in the analysis.|||Percentage of Participants|||Number
2603568|NCT02131064|Secondary|Invasive Disease-free Survival (IDFS)|IDFS is defined only for participants who undergo surgery. IDFS is defined as the time from surgery to the first documented occurrence of an IDFS event, defined as: Ipsilateral invasive breast tumor recurrence; Ipsilateral local−regional invasive breast cancer recurrence; Distant recurrence; Contralateral invasive breast cancer; and death from any cause. 3 years of IDFS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after treatment.|From surgery to the first documented occurrence of IDFC event (up to approximately 47 months)|The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment.|||Probability||95% Confidence Interval|Number
2603569|NCT02131064|Secondary|Event-Free Survival|Event-free survival (EFS) is defined as the time from randomization to disease progression or disease recurrence (local, regional, distant, or contralateral, invasive or non-invasive), or death from any cause. 3 years EFS rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after treatment.|From randomization up to disease progression or recurrence or death (up to approximately 47 months)|The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment.|||Probability||95% Confidence Interval|Number
2603570|NCT02131064|Secondary|Percentage of Participants Who Received Breast-Conserving Surgery (BCS)|BCS rate was defined as the percentage of participants who achieve BCS out of the ITT population of participants without inflammatory breast cancer.|Surgery performed after completion of neoadjuvant therapy (approximately 6 months after neoadjuvant period)||||Percentage of Participants||95% Confidence Interval|Number
2603646|NCT02130557|Other Pre-specified|Number of Participants With Vital Signs Abnormalities|Criteria for vital signs abnormalities: systolic blood pressure (SBP) <80 millimeter of mercury (mmHg), >210 mmHg; diastolic blood pressure (DBP) <40 mmHg, >130 mmHg; heart rate <40 beats per minute (bpm), >150 bpm; temperature <32 degree celsius, >40 degree celsius.|Baseline up to 752 days|Safety Population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received.|||Participants|||Count of Participants
2603571|NCT02131064|Secondary|Overall Survival|Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. 3 years OS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after treatment.|From randomization until death (up to approximately 47 months)|The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment.|||Probability||95% Confidence Interval|Number
2603572|NCT02131064|Primary|Percentage of Participants With Total Pathological Complete Response (tpCR) Assessed Based on Tumor Samples|tpCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes ( that is [i.e.], ypT0/is, ypN0 in the American Joint Committee on Cancer [AJCC] staging system, 7th edition). Percentage of participants with tpCR was reported.|Pre-surgery (within 6 weeks after neoadjuvant therapy; up to approximately 6 months)|The Intent-to-treat (ITT) Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment.|||Percentage of Participants||95% Confidence Interval|Number
2603573|NCT02130999|Other Pre-specified|Number of Participants That Reported Suicidal Ideation, Suicidal Behavior, or Suicide Attempts.|Number of Participants that reported suicidal ideation, suicidal behavior, or suicide attempts per treatment arm and overall.|Baseline to End of Study Day 5 (± 2 days).||||participants|||Number
2603574|NCT02130999|Secondary|Number of Participants With Adverse Events|Number of participants with treatment-emergent adverse event per treatment arm and overall.|From Baseline to End of Study; Day 5 (± 2 days).||||participants|||Number
2603575|NCT02130999|Secondary|Metabolite-to-parent AUC(Inf) Ratios After Oral Administration of a Single 20 mg Dose and IV Administration of a Single 2 mg Dose of Tasimelteon|Comparison of the metabolite-to-parent AUC(inf) ratios for the oral and IV routes.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose||||metabolite to parent AUC (inf) ratios||Standard Deviation|Mean
2603576|NCT02130999|Secondary|AUC(Inf) of Tasimelteon's Metabolites After a Single Oral and I.V. Dose|The mean +/- SD for the AUC(inf) of tasimelteon's metabolites after a single 20 mg oral dose of tasimelteon and after a single 2 mg I.V. administration of tasimelteon|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose|Only 11 subjects could be analyzed for M11.|||h*ng/mL||Standard Deviation|Mean
2603577|NCT02130999|Secondary|Cmax of Tasimelteon's Metabolites After an Oral and I.V. Dose of Tasimelteon|The mean +/- SD for the Cmax of tasimelteon's metabolites after a single 20 mg oral dose of tasimelteon and after a single 2 mg I.V. administration of tasimelteon|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose||||ng/mL||Standard Deviation|Mean
2603578|NCT02130999|Secondary|Total Clearance of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration.|CL of tasimelteon will be compared when given orally or administered as an I.V.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose||||(mL/min)||Standard Deviation|Mean
2603579|NCT02130999|Secondary|T1/2 of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration.|T1/2 of tasimelteon will be compared when given orally or administered as an I.V.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours pos-dose||||hour||Standard Deviation|Mean
2603580|NCT02130999|Secondary|AUC (Inf) of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration.|AUC (inf) of Tasimelteon will be compared when given orally or administered as an I.V.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose||||(h*ng/mL)||Standard Deviation|Mean
2603581|NCT02130999|Secondary|Cmax of Tasimelteon After a Single 20 mg Oral Dose and After a Single 2 mg I.V. Administration.|Cmax of tasimelteon will be compared when given orally or administered as an I.V.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose||||ng/mL||Standard Deviation|Mean
2603582|NCT02130999|Primary|Absolute Bioavailability After a Single Oral Dose of Hetlioz™(Tasimelteon) 20mg|The absolute bioavailability (F) of tasimelteon will be estimated from the dose-corrected AUC(inf) after oral and I.V. administration using an analysis of variance (ANOVA) model with treatment, period, sequence, and subject within sequence as the classification variables, using natural log-transformed data. The geometric mean ratio (GMR), oral-to-I.V., and its associated 90% confidence interval (CI) will be used as the estimate of F and its variability.|pre-dose, -0.125, 0, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose||||Geometric Mean Ratio (%)||90% Confidence Interval|Geometric Mean
2603583|NCT02130986|Secondary|Antibiotic Prescription in Emergency Department(ED)|Antibiotic prescription in the ED includes post-randomization receipt of antibiotics in ED and provision of an antibiotic prescription for patients at the time of discharge from the ED.|While in the ED or before ED discharge (majority patients < 1 day)||||Participants|||Count of Participants
2603584|NCT02130986|Primary|Number of Participants With Any Adverse Outcome|"Primary Safety Outcome - Combined endpoint of adverse outcomes (death, endotracheal intubation, vasopressors, renal failure, lung abscess/empyema, pneumonia in non-CAP patient, and hospital readmissions) that could be attributable to withholding antibiotics in lower respiratory tract infection (LRTI).~Number is based on the number of participants that experienced any adverse outcome."|30 days||||Participants|||Count of Participants
2603585|NCT02130986|Primary|Total Antibiotic Exposure Days|Total antibiotic exposure, defined as the total number of antibiotic-days by Day 30.|30 days|Mixed modeling was used to impute missing data for the intention-to-treat analysis for the primary outcome since not all patients could be reached for the 30 day interview (which collected 30 day antibiotic use).|||days||Standard Deviation|Mean
2603586|NCT02130765|Secondary|Number of Subjects That Had a Cardiovascular (CV) Hospitalizations or CV-related ER Visit|Number of subjects that had a CV hospitalization or CV-related ER visit through 12 month follow up.|12 months||||Participants|||Count of Participants
2603893|NCT02127710|Secondary|Apparent Volume of Distribution of AZD6094 Following Single Dose|The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.|24 Hours||||Liters||Standard Deviation|Mean
2603589|NCT02130635|Secondary|Part B: Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Screening and Follow-up|FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the maximum amount of air that can be forcibly blown out after a maximum inspiration. FEV1 and FVC measurements were repeated until three technically acceptable measurements (within 150 milliliters of each other) had been made. Only the best of three measurements were recorded.|Screening (up to 30 days prior to Day 1) and Follow-up (approximately Day 19)|Safety Population|||Liters||95% Confidence Interval|Mean
2603590|NCT02130635|Secondary|Part B: Number of Participants With Normal and Abnormal (Clinically Significant or Not Clinically Significant) Findings in 12-lead Electrocardiogram (ECG) at Any Visit Post-Baseline|Baseline was the Day 1 (pre-dose) measurement. Single 12-lead ECGs were obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and corrected QT intervals. Day 7 assessments could be conducted on Day 7 or Day 8.|Day 1, Day 7, and Day 14|Safety Population|||Participants|||Number
2603591|NCT02130635|Secondary|Part B: Number of Participants Meeting Criteria of Potential Clinical Importance for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Heart Rate (HR) at Any Visit Post-Baseline|Baseline was the Day 1 pre-dose measurement. Vital signs (SBP, DBP, and HR) were measured at Day 1 (30 minutes [min] and 6 h post-dose), Day 7 (pre-dose), and Day 14 (24 h post-dose). All measurements were obtained in supine position, after a 5-minute rest. Day 7 assessments could be conducted on Day 7 or Day 8.|Day 1, Day 7, and Day 14|Safety Population|||Participants|||Number
2603592|NCT02130635|Secondary|Part B: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
2603593|NCT02130635|Secondary|Part B: Change From Baseline in Creatinine, Bilirubin, and Total Bilirubin at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||Micromoles/Liter (micromol/L)||Standard Deviation|Mean
2603594|NCT02130635|Secondary|Part B: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||International Units per Liter (IU/L)||Standard Deviation|Mean
2603595|NCT02130635|Secondary|Part B: Change From Baseline in Albumin and Total Protein at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||g/L||Standard Deviation|Mean
2603596|NCT02130635|Secondary|Part B: Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. MCV is one of the RBC indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||fL||Standard Deviation|Mean
2603597|NCT02130635|Secondary|Part B: Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. MCH is one of the red blood cell indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||pg||Standard Deviation|Mean
2603598|NCT02130635|Secondary|Part B: Change From Baseline in Hematocrit at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||Ratio||Standard Deviation|Mean
2603599|NCT02130635|Secondary|Part B: Change From Baseline in Counts of RBCs and Reticulocytes at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||10^12 cells/Liter (TI/L)||Standard Deviation|Mean
2603600|NCT02130635|Secondary|Part B: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. MCHC is one of the red blood cell (RBC) indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||g/L||Standard Deviation|Mean
2603601|NCT02130635|Secondary|Part B: Change From Baseline in Counts of Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, White Blood Cells (WBC), Total Neutrophils (Total ANC) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
2603894|NCT02127710|Secondary|Time to Peak Plasma Concentration of AZD6094 After Single Dose|The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.|24 Hours||||Hours||Full Range|Median
2603602|NCT02130635|Secondary|Part B: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5. AEs were classified as potentially drug-related, based on the investigator's judgment. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the start of study treatment until follow-up (assessed for approximately 19 days)|Safety Population|||Participants|||Number
2603603|NCT02130635|Secondary|Part B: Number of Times Rescue Medication Was Used by Participants Daily, During the Treatment Period|Rescue medication was identified from concomitant medication records and the patient diaries which were provided to the participants to record data throughout the treatment period. Only participants who used rescue medication were analyzed. The value NA indicates that the standard deviation could not be calculated as only one participant was analyzed.|Day 1 to Day 15|Safety Population|||Number of times||Standard Deviation|Mean
2603604|NCT02130635|Secondary|Part B: Trough Concentration (Ctau) of GSK2269577 on Day 7 and Day 15|Blood samples were collected to determine the (trough) plasma concentration of GSK2269577 on Day 7 (pre-dose) and Day 15 (24 hours after dosing on Day 14). Day 7 assessments could be done either on Day 7 or on Day 8.|Day 7 and Day 15|PK Population|||pg/mL||95% Confidence Interval|Geometric Mean
2603605|NCT02130635|Secondary|Part A: Trough Concentration (Ctau) of GSK2269577 on Day 7 and Day 15|Blood samples were collected to determine the (trough) plasma concentration of GSK2269577 on Day 7 (pre-dose) and Day 15 (24 hours after dosing on Day 14). Day 7 assessments could be done either on Day 7 or on Day 8.|Day 7 and Day 15|PK Population|||pg/mL||95% Confidence Interval|Geometric Mean
2603606|NCT02130635|Secondary|Part B: Maximum Observed Plasma Concentration (Cmax) of GSK2269577 on Day 7|Blood samples were collected to determine the plasma concentrations of GSK2269577 immediately after dosing on Day 7. Concentration values were log-transformed. Day 7 sampling could be done on Day 7 or Day 8.|Day 7 immediately after dosing|PK Population|||pg/mL||95% Confidence Interval|Geometric Mean
2603607|NCT02130635|Secondary|Part A: Maximum Observed Plasma Concentration (Cmax) of GSK2269577 on Day 7|Blood samples were collected to determine the plasma concentrations of GSK2269577 immediately after dosing on Day 7. Day 7 sampling could be done on Day 7 or Day 8.|Day 7 immediately after dosing|PK Population|||pg/mL||95% Confidence Interval|Geometric Mean
2603608|NCT02130635|Secondary|Part B: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose|A 2 mL blood sample for pharmacokinetic (PK) analysis was collected at each of the indicated time point. Concentration measurements were log-transformed. Only those participants who were available at the indicated time points were analyzed (represented by n=X,X in the category titles). A value of NA indicates that the geometric mean or 95% confidence interval is not available.|Pre-dose, and 5 min, 30 min, 1 h, 2 h, 4 h, and 6 h post-dose on Day 1|PK Population|||pg/mL||95% Confidence Interval|Geometric Mean
2603609|NCT02130635|Secondary|Part A: Day 1 Plasma Concentration of GSK2269577 up to 6 Hours Post Dose|A 2 mL blood sample for pharmacokinetic (PK) analysis was collected at each of the indicated time point. Only those participants who were available at the indicated time points were analyzed (represented by n=X in the category titles). A value of NA indicates that the geometric mean or 95% confidence interval is not available.|Day 1 (Pre-dose, 5 min, 30 min, 1, 2, 4 & 6 hours post-dose)|PK Population: participants in the Safety Population for whom a PK sample was obtained and analyzed.|||pg/mL||95% Confidence Interval|Geometric Mean
2603610|NCT02130635|Primary|Part B: Adjusted Median Response of Cytokine (Interleukin 6 [IL6], Interleukin 8 [IL8], Tumor Necrosis Factor Alpha [TNFalpha]) Concentrations in Induced Sputum, on Day 7 and Day 14|This outcome measure was used to estimate the inhibition levels of various doses of GSK2269557 by analyzing inflammatory cytokines IL6, IL8, and TNF alpha using Bayesian methods of statistical analysis, using non-informative prior distributions for all modeling parameters. Posterior medians (adjusted median response) and 95% credible intervals are reported here as medians and 95% confidence intervals respectively. 95% credible interval is reported as 2-sided 95% confidence in the statistical analyses. Day 7 assessments could be conducted on Day 7 or Day 8.|Day 7 (pre-dose) and Day 14 (24 h post-dose)|Safety Population|||Picograms/milliliter (pg/mL)||95% Confidence Interval|Median
2603611|NCT02130635|Primary|Part A: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points|Baseline is Day 1 pre-dose. FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the maximum amount of air that can be forcibly blown out after a maximum inspiration. FEV1 and FVC measurements were repeated until three technically acceptable measurements (within 150 milliliters of each other) had been made. Only the best of three measurements were recorded. Baseline was the maximum of the planned pre-dose measurements on Day 1. Change from Baseline at any post-dose time point was calculated as the post-dose value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 1 (1 h post-dose), Day 7 (pre-dose and 1 h post-dose), and Day 14 (24 h post-dose)|Safety Population|||Liters||95% Confidence Interval|Mean
2603612|NCT02130635|Primary|Part A: Number of Participants With Normal and Abnormal (Clinically Significant or Not Clinically Significant) Findings in 12-lead Electrocardiogram (ECG) at Any Visit Post-Baseline|Baseline was the Day 1 (pre-dose) measurement. Single 12-lead ECGs were obtained using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, and corrected QT intervals. Clinical significance was judged by the investigator. Day 7 assessments could be conducted on Day 7 or Day 8.|Day 1, Day 7, and Day 14|Safety Population|||Participants|||Number
2603752|NCT02129556|Secondary|Overall Survival (OS) at 12 Months|OS is defined as the time from the first dose of trial treatment to death from any cause. For patients who are lost to follow-up or who have no documentation of death at the time of final analysis, follow-up is censored at the date of last assessment of vital status. OS at 12 months by Kaplan-Meier estimates.|Time from start of trial treatment to death from any cause, assessed up to 30 months||||proportion of participants||90% Confidence Interval|Number
2603613|NCT02130635|Primary|Part A: Number of Participants Meeting Criteria of Potential Clinical Importance for Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Heart Rate (HR) at Any Visit Post-Baseline|Baseline was the Day 1 pre-dose measurement. Vital signs (SBP, DBP, and HR) were measured at Day 1 (30 minutes [min] and 6 h post-dose), Day 7 (pre-dose), and Day 14 (24 h post-dose). Potential clinical concern range for SBP was <85 millimeters of mercury (mmHg) (low) and >160 mmHg (high), for DBP <45 mmHg (low) and >100 mmHg (high) and for HR <40 bpm and >110 bpm. All measurements were obtained in supine position, after a 5-minute rest. Day 7 assessments could be conducted on Day 7 or Day 8.|Day 1, Day 7, and Day 14|Safety Population|||Participants|||Number
2603614|NCT02130635|Primary|Part A: Change From Baseline in Calcium, Potassium, Sodium, Glucose, and Blood Urea Nitrogen (BUN) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||Millimoles per Liter (mmol/L)||Standard Deviation|Mean
2603615|NCT02130635|Primary|Part A: Change From Baseline in Creatinine, Bilirubin, and Total Bilirubin at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||Micromoles/Liter (micromol/L)||Standard Deviation|Mean
2603616|NCT02130635|Primary|Part A: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||International Units per Liter (IU/L)||Standard Deviation|Mean
2603617|NCT02130635|Primary|Part A: Change From Baseline in Albumin and Total Protein at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||g/L||Standard Deviation|Mean
2603618|NCT02130635|Primary|Part A: Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. MCV is one of the RBC indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||Femtoliters (fL)||Standard Deviation|Mean
2603619|NCT02130635|Primary|Part A: Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. MCH is one of the red blood cell indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||Picograms (pg)||Standard Deviation|Mean
2603620|NCT02130635|Primary|Part A: Change From Baseline in Counts of RBCs and Reticulocytes at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||10^12 cells/Liter (TI/L)||Standard Deviation|Mean
2603621|NCT02130635|Primary|Part A: Change From Baseline in Hematocrit at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||Ratio||Standard Deviation|Mean
2603622|NCT02130635|Primary|Part A: Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. MCHC is one of the red blood cell (RBC) indices. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 h post-dose)|Safety Population|||Grams/Liter (g/L)||Standard Deviation|Mean
2603623|NCT02130635|Primary|Part A: Change From Baseline in Counts of White Blood Cells (WBC), Total Neutrophils (Total Absolute Neutrophil Count [ANC]), Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets at the Indicated Time Points|Blood samples were collected for measurement for the indicated tests. Baseline is Day 1 pre-dose. Change from Baseline at any post-dose visit was calculated as the post-dose visit value minus the Baseline value. Day 7 assessments could be conducted on Day 7 or Day 8.|Baseline (Day 1 [pre-dose]), Day 7 (pre-dose), and Day 14 (24 hours [h] post-dose)|Safety Population|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
2603654|NCT02130557|Secondary|Percentage of Participants With Complete Cytogenetic Response (CCyR) by Month 12|Complete Cytogenetic Response (CCyR) was based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow (BM) aspirate. CCyR was achieved when there was 0 % Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or MMR if no BM was available.|up to Month 12|mITT population included all randomized participants with Philadephia chromosome positive CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies >0 with study drug assignment designated according to initial randomization.|||percentage of participants||95% Confidence Interval|Number
2603895|NCT02127710|Secondary|Peak Plasma Concentration of AZD6094 Following Single Dose|The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.|24 Hours||||ng/mL||Standard Deviation|Mean
2603624|NCT02130635|Primary|Part A: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5. AEs were classified as potentially drug-related, based on the investigator's judgment. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the start of study treatment until follow-up (assessed for approximately 19 days)|Safety Population: all participants who received at least one dose of study treatment.|||Participants|||Number
2603625|NCT02130622|Secondary|The Impact on Work Activity as Measured by the Work Productivity and Activity Impairment Questionnaire. (WPAI).||4 weeks|Insufficient recruitment resulting in insufficient data to analyze||||||
2603626|NCT02130622|Secondary|Use of Rescue Medication|"Frequency of use of the rescue medication meclizine"|4 weeks|Data not collected||||||
2603627|NCT02130622|Secondary|Occurrence of Adverse Events||4 weeks|Insufficient recruitment resulting in insufficient data to analyze||||||
2603628|NCT02130622|Primary|Change in Patient-reported Symptoms as Measured by the Gastroparesis Cardinal Symptom Index Score (GCSI, 14) From Week 0 to Week 4.||4 weeks|Insufficient recruitment resulting in insufficient data to analyze||||||
2603629|NCT02130583|Other Pre-specified|Hopelessness Scale for Children|The Hopelessness Scale for Children is a 17 item self-report scale with statements (e.g., I want to grow up because I think things will be better) that are rated as either True or False. Some statements are reverse coded. Higher scores indicate higher hopelessness, with a maximum score of 17 and a minimum score of 0.|Baseline, 1 month Post-Treatment, 4 month Follow-Up|Some participants were lost to follow up.|||units on a scale||Standard Deviation|Mean
2603630|NCT02130583|Secondary|Columbia Impairment Scale Parent Version|The Columbia Impairment Scale (parent version) is a 13-item scale in which parents are asked to respond about their child's impairment in a variety of domains on a scale of 0 (no problem at all) to 4 (very bad problem). Scores are summed such that higher scored indicate higher functional impairment, with a maximum score of 52 and a minimum score of 0.|Base, 1 month Post-Treatment, 4 month Follow-Up|Some participants' parents did not participate (e.g. if teen was = 18 y/o); Also, some parents were lost to follow-up.|||units on a scale||Standard Deviation|Mean
2603631|NCT02130583|Secondary|Beck Depression Inventory|"The Beck Depression Inventory is a 21 item self-report form of depression but can be and has been administered to the parent to respond about their child. This questionnaire consists of 21 groups of statements. For example, for Sadness, respondents are asked to select between 0 (My child does not feel sad.), 1 (My child feels sad much of the time), 2 (My child is sad all the time), and 3 (My child is so sad or unhappy that he/she can't stand it.). Higher scores indicate higher depression with a maximum score of 63 and a minimum score of 0."|Baseline, 1 month Post-Treatment, 4 month Follow-Up|Some participants' parents did not participate (e.g. if teen was = 18 y/o); Also, some parents were lost to follow-up.|||units on a scale||Standard Deviation|Mean
2603632|NCT02130583|Secondary|Suicide Ideation Questionnaire (SIQ)|"The Suicidal Ideation Questionnaire is a 30 item self-report measure that was administered to the adolescent to ascertain the frequency of thoughts of death and suicide. Respondents are asked how often they have had these thoughts (e.g., I thought about killing myself) in the past month ranging from almost every day = 1 to I never had this thought =7. Scores are then reversed and transformed such that higher scores indicate higher suicidal ideation, with a range of 180 (highest suicidal ideation) to 0 (no suicidal ideation)."|Baseline, 1 month Post-Treatment, 4 month Follow-Up|Some participants were lost to follow up.|||units on a scale||Standard Deviation|Mean
2603633|NCT02130583|Primary|Suicide Events|Number of participants who have attempted suicide or have had emergency intervention to intercede a suicide attempt.|1 month, 6 month|Some participants were lost to follow-up|||Participants|||Count of Participants
2603634|NCT02130583|Primary|Modified Differential Emotions Scale (Positive Emotions Sub-scale)|"The Modified Differential Emotions Scale is a self-report measure comprised of ratings for positive and negative affect. For example, participants are asked to rate the extent to which they feel Content, serene, peaceful right now on a likert scale ranging from 1 (not at all) to 5 (extremely). The scores reported are averages for the positive emotions, and thus can be interpreted as ranging from 1 (not at all) to 5 (extremely). We expected an increase in positive affect ratings following the intervention."|Base, 1 month Post-Treatment, 4 month Follow-Up|Some participants were lost to follow-up.|||units on a scale||Standard Deviation|Mean
2603635|NCT02130583|Primary|Dot Probe Task|Dot probe tasks are administered to assess for attentional biases. The task is a computer task in which participants are presented with stimuli (e.g., words) of different valences (positive/negative/neutral) at the same time (e.g., smiling face and a neutral face), followed by a probe (*) on one side. Participants are asked to hit a key that corresponds to the correct side in which the probe appeared. The reaction time of their response is indicative of their attention to the valenced image/word. Trials are counterbalanced so that valences appear equally on each side. Faster reaction time (less milliseconds) to positive images/words indicates an attentional bias for positive stimuli. The scores reported here represent bias scores. Positive scores indicate a bias to positive stimuli, negative scores indicate a bias towards neutral stimuli.|Baseline, 1 month Post Treatment, 4 month Follow-Up|Numbers may differ due to participant attrition and invalid profiles.|||milliseconds||Standard Deviation|Mean
2603636|NCT02130570|Secondary|Post-Discharge Health Care Utilization|We will measure emergency department visits and hospital readmissions within 30 days of discharge using a combination of administrative data for all Partners hospitals plus patient report for all utilization outside the Partners system.|30 days after discharge|Post Discharge ED visits within 30 days of discharge were not able to be obtained from the second site MGH. Post discharge readmissions were obtained, however, without the ED visit data from MGH we are unable to create a count for Post-Discharge Health Care Utilization (ED plus readmissions).||||||
2603637|NCT02130570|Secondary|Proportion of Participants With Positive Responses Regarding Patient Engagement and Opinions of the Discharge Process|"During the 30 day post-discharge follow-up phone call we asked patients about their participation in, understanding of, and ability to carry out the post-discharge plan. These questions include questions from the Interpersonal Processes of Care survey and several additional questions from the HOMERUN study of readmitted patients.~In the table below, we have abbreviated each survey question since the number of characters is limited in this field in the table. We have pasted below the full survey question.~When you were getting ready to leave the hospital one month ago, how often did your care team use medical terminology that you did not understand?~How often did you feel confused about what was going on with your medical care because they did not explain things well?~How often did they give you enough time to say what you thought was important regarding your medical care?~How often did they listen carefully to what you had to say?~How often did you feel p"|30 days after discharge|1679 participants were enrolled in the study, however, 22 patients were lost to follow-up and therefore not included in the analysis (e.g., patient withdrew consent, patient died during index admission). Not all patients answered the 30-day patient survey.|||proportion of participants|||Number
2603638|NCT02130570|Secondary|Change in Functional Status on the Modified Medical Outcomes Survey Short Form-12 (SF-12v2) From One Month Prior to Admission to 30 Days After Discharge.|"During the inpatient enrollment period, patients will complete a modified Medical Outcomes Survey Short Form-12 (SF-12v2). The SF-12v2 measures a patient's functional status and health-related quality of life one month prior to admission. 30 days after discharge, SF12 questions will be repeated so that functional status and health-related quality of life can be compared to prior to admission.~This measure is a 12-item measure. Each item 5 possible responses with a value from 1 to 5 (with higher scores indicating worse outcomes). A summary score is computed by summing the score on each item. Therefore, the range of summary scores for the SF-12v2 is a minimum of 12 and a maximum of 60."|One month prior to admission to 30 days after discharge.|1679 participants were enrolled in the study, however, 22 patients were lost to follow-up and therefore not included in the analysis (e.g., patient withdrew consent, patient died during index admission).|||units on a scale||Standard Deviation|Mean
2603639|NCT02130570|Secondary|Number of Patients With a Nonelective Readmission Within 30 Days of the Index Discharge Date|Nonelective readmission within 30 days of the index discharge date|30 days after discharge|1679 participants were enrolled in the study, however, 22 patients were lost to follow-up and therefore not included in the analysis (e.g., patient withdrew consent, patient died during index admission).|||participants|||Number
2603640|NCT02130570|Secondary|Proportion of Participants With New or Worsening Signs/Symptoms Within 30 Days of Discharge|New or worsening signs or symptoms, i.e. unpleasant symptoms, loss of function, abnormal lab results, and/or additional medical care within 30 days after discharge.|30 days after discharge|1679 participants were enrolled in the study, however, 22 patients were lost to follow-up and therefore not included in the analysis (e.g., patient withdrew consent, patient died during index admission).|||proportion of participants||95% Confidence Interval|Number
2603641|NCT02130570|Primary|Proportion of Participants With an Adverse Event Within 30 Days After Index Discharge Date|Proportion of Participants With an Adverse Event Within 30 Days after Index Discharge Date|30 days after discharge|1679 participants were enrolled in the study, however, 22 patients were lost to follow-up and therefore not included in the analysis (e.g., patient withdrew consent, patient died during index admission).|||proportion of participants||95% Confidence Interval|Number
2603642|NCT02130557|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events By National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on NCI CTCAE version 4.03. Grade 1 =mild; Grade 2 =moderate; Grade 3 =severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4 =life-threatening or disabling, urgent intervention indicated; Grade 5 =death. Treatment-emergent events were events between first dose of study drug and up to 752 days that were absent before treatment that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 adverse event, only the maximum CTCAE was reported.|Baseline up to 752 days|Safety Population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received.|||Participants|||Count of Participants
2603643|NCT02130557|Other Pre-specified|Number of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 752 days|Safety Population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received.|||Participants|||Count of Participants
2603644|NCT02130557|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern|Criteria for ECG abnormalities : heart rate: increase of >15 bpm from baseline value and >=120 bpm, decrease of >15 bpm from baseline value and <=45 bpm; PR interval: change of >=20 msec from baseline value and >=220 milliseconds (msec); QRS interval >=120 msec; QTcB interval >500 msec, increase of >60 msec from baseline; QT interval using Fridericia's correction (QTcF) >500 msec, increase of >60 msec from baseline, <=450 msec (Men) or <=470 msec (Women), >450 msec (Men) or >470 msec (Women).|Baseline up to 752 days|Safety Population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received.|||Participants|||Count of Participants
2603645|NCT02130557|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) Version 4.03|Laboratory parameters included hematological (haemoglobin, lymphocytes (absolute), neutrophils (absolute), platelets and leukocytes) and biochemistry (albumin, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, amylase, bilirubin, creatinine kinase, calcium, creatinine, glucose, potassium, lipase, magnesium, phosphate, sodium, urate) parameters. Abnormalities in laboratory tests were graded by NCI CTCAE version 4.03 as Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.|Baseline up to 752 days|Safety Population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received.|||Participants|||Count of Participants
2603647|NCT02130557|Other Pre-specified|Summary of Trough Plasma Concentration by Presence of Grade 3 or Higher Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death. Trough plasma concentration of participants who had grade 3 or higher AE are presented in this outcome measure. Data of plasma concentration is reported separatley for each preferred term of AE.|Day 28, 56, 84|"PK population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here,N signifies number of participants evaluable for this outcome measure and n signifies participants evaluable at specified time points only."|||ng/mL||Standard Deviation|Mean
2603648|NCT02130557|Other Pre-specified|Summary of Trough Plasma Concentration by Presence of Grade 1 or Higher Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death. Trough plasma concentration of participants who had grade 1 or higher AE are presented in this outcome measure. Data of plasma concentration is reported separately for each preferred term of AE.|Day 28, 56, 84|"PK population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here,N signifies number of participants evaluable for this outcome measure and n signifies participants evaluable at specified time points only."|||ng/mL||Standard Deviation|Mean
2603649|NCT02130557|Other Pre-specified|Summary of Trough Plasma Concentration by Major Molecular Response (MMR)|MMR was defined as a ratio of Bcr-Abl/Abl <=0.1% on the international scale (>=3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts) by quantitative RT-qPCR. Trough plasma concentration of participants who had MMR are presented in this outcome measure.|Day 28, 56, 84|"PK population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here,N signifies number of participants evaluable for this outcome measure and n signifies participants evaluable at specified time points only."|||ng/mL||Standard Deviation|Mean
2603650|NCT02130557|Other Pre-specified|Summary of Trough Plasma Concentration by Complete Cytogenetic Response (CCyR)|CCyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a BM aspirate. CCyR was achieved when there was 0 % Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or MMR if no BM was available. Trough plasma concentration of participants who had CCyR are presented in this outcome measure.|Day 28, 56, 84|"Pharmacokinetic (PK) population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here,N signifies number of participants evaluable for this outcome measure and n signifies participants evaluable at specified time points only."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2603651|NCT02130557|Secondary|Percentage of Participants Alive at Month 12|OS was defined as the time (in months) from randomization to the occurrence of death due to any cause or censoring. Kaplan-meier analysis was used for determination of OS. The comparative analysis between the two arms for this member of the long-term secondary family will be done at the end of the study. Percentage of participants who were alive were estimated in this outcome measure.|Month 12|mITT population included all randomized participants with Philadephia chromosome positive CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies >0 with study drug assignment designated according to initial randomization.|||percentage of participants||95% Confidence Interval|Number
2603652|NCT02130557|Secondary|Cumulative Incidence of Event Free Survival (EFS) Events at Month 12|EFS was defined as the time from randomization to death due to any cause, transformation to AP or BP at any time, confirmed loss of complete hematologic response (CHR), confirmed loss of CCyR or censoring. Loss of CHR was defined as a hematologic assessment of non-CHR [chronic phase, AP, or BP] confirmed by 2 assessments at least 4 weeks apart). Loss of CCyR was defined as at least 1 Ph+ metaphase from analysis of <100 metaphases confirmed by a follow up cytogenetic analysis after 1 month. Cumulative incidence of EFS event at month 12 was adjusted for competing risk of treatment discontinuation without the event. The comparative analysis between the two arms for this member of the long-term secondary family will be done at the end of the study.|Month 12|mITT population included all randomized participants with Philadephia chromosome positive CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies >0 with study drug assignment designated according to initial randomization.|||percentage of participants||95% Confidence Interval|Number
2603653|NCT02130557|Secondary|Duration of Complete Cytogenetic Response (CCyR)|It was defined as the time from the first date of CCyR until the date of the confirmed loss of CCyR or censoring. Confirmed Loss of CCyR was the presence of at least one Ph+ metaphase confirmed by a second assessment at least 28 days later. Treatment discontinuation due to progressive disease (PD) or death due to PD within 28 days of last dose were considered confirmed loss of CCyR. PD was defined as disease progression to accelerated phase or blast phase CML. Kaplan meier analysis was used for the determination of duration of CCyR. Duration of response will be analyzed for responders only therefore duration of response will be excluded from the long-term family of secondary outcome measures.|From the date of first CCyR until the date of confirmed loss of CCyR or censoring (up to 752 days)|mITT population included all randomized participants with Philadephia chromosome positive CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies >0 with study drug assignment designated according to initial randomization. N=number of participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Median
2603668|NCT02130258|Primary|Pre-epidural Warm Sensation Quantitative Sensory Testing (QST) Results|QST tests for changes in spinal nerves. A small metal plate, called a thermode, is placed on the subject's arm. During the warm sensation test, the plate slowly increases in temperature.The subject will stop the test as soon as the plate feels warm. This temperature is recorded and can range from 32-53 degrees Celsius. The same test is repeated on the subject's leg that has radicular pain. The difference in temperatures from the test on the subject's arm and leg were analyzed.|Baseline measurement before the epidural injection||||Degrees Celsius||Standard Deviation|Mean
2603655|NCT02130557|Secondary|Duration of Major Molecular Response (MMR)|It was defined as the time from the first date of MMR until the date of the confirmed loss of MMR or censoring. Confirmed Loss of MMR was Bcr-Abl/Abl IS ratio >0.1% in association with a >=5-fold increase in Bcr-Abl/Abl IS ratio from the lowest value achieved up to that time-point confirmed by a second assessment at least 28 days later. Treatment discontinuation due to progressive disease (PD) or death due to PD within 28 days of last dose were considered confirmed loss of MMR. PD was defined as disease progression to accelerated phase or blast phase CML. Kaplan-meier analysis was used for determation of duration of MMR. Duration of response will be analyzed for responders only therefore duration of response will be excluded from the long-term family of secondary outcome measures.|From the date of first MMR until the date of confirmed loss of MMR or censoring (up to 752 days)|mITT population included all randomized participants with Philadephia chromosome positive CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies >0 with study drug assignment designated according to initial randomization. N(overall number of participants analyzed)=number of participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Median
2603656|NCT02130557|Secondary|Major Molecular Response (MMR) by Month 18|"MMR was defined as a ratio of Bcr-Abl/Abl <=0.1% on the international scale (>=3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts [>=3000 Abl required]) by quantitative RT-qPCR.~It will be tested at the 1-sided significance level of 0.0125."|up to Month 18|The data for this outcome measure was immature as not all participants still on-treatment but without achieving MMR had reached the Month 18 visit at the time of data cut-off.||||||
2603657|NCT02130557|Primary|Percentage of Participants With Major Molecular Response (MMR) at Month 12|MMR was defined as a ratio of breakpoint cluster region to abelson (Bcr-Abl/Abl) less than or equal to (<=) 0.1 percent (%) on the international scale (IS) (greater than or equal to [>=] 3 log reduction from standardized baseline in ratio of Bcr-Abl to Abl transcripts [>=3000 Abl required]) by quantitative reverse transcriptase polymerase chain reaction (RT-qPCR).|Month 12|Modified intent-to-treat (mITT) population included all randomized participants with Philadephia chromosome positive CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies greater than (>) 0 with study drug assignment designated according to initial randomization.|||percentage of participants||95% Confidence Interval|Number
2603658|NCT02130284|Other Pre-specified|Device Metric/Performance - All Device Deficiencies||From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures||||device performance issues|||Number
2603659|NCT02130284|Other Pre-specified|Sensor Performance: Accuracy|MARD (Mean Absolute Relative Difference) between sensor glucose value and YSI. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100).|From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures|Total of 71 subjects completed the study. However, two subjects who withdrew also had YSI and Sensor glucose values. Therefore, total of 73 subjects contributed to sensor accuracy analysis|||percentage||Standard Deviation|Mean
2603660|NCT02130284|Other Pre-specified|PLGM Performance - Hypoglycemia Event Rate at Threshold of YSI <= 65 mg/dL.|Hypoglycemic event rate among 71 subjects who underwent the PLGM experiment. Hypoglycemic events are defined based on: occurrence of 2 or more continuous YSI <= 65 mg/dL during in-clinic procedures.|From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures|Two subjects were excluded from analysis because the site staff did not set the pump up correctly prior to YSI and the PLGM feature was never set to activate.|||percentage of total subjects|||Number
2603661|NCT02130284|Primary|Rescue Events During In-clinic Procedues||From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures||||Participants|||Count of Participants
2603662|NCT02130284|Primary|Diabetic Ketoacidosis|Evaluation of DKA during in-clinic procedures|From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures||||Participants|||Count of Participants
2603663|NCT02130284|Primary|Severe Hypoglycemia|Evaluation of incidence of severe hypoglycemia during in-clinic procedures|From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures||||Participants|||Count of Participants
2603664|NCT02130284|Primary|Unanticipated Device Effect (UADE)|Evaluation of incidence of UADE during in-clinic procedures|From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures||||Participants|||Count of Participants
2603665|NCT02130284|Primary|Serious Adverse Events (SAE)|Evaluation of incidence of SAE during in-clinic procedures|From start of in clinic procedures until the end of the study, which may occur up to 48 hours after the start of in-clinic procedures||||Participants|||Count of Participants
2603666|NCT02130258|Primary|Post-epidural Cold Pain Threshold QST Results|The thermode is placed on the subject's arm. During the cold pain threshold test, the plate slowly decreases in temperature.The subject will stop the test when the plate is at their minimal tolerable temperature. This temperature is recorded and can range from 32-0 degrees Celsius. The same test is repeated on the subject's leg that has radicular pain. The difference in temperatures from the test on the subject's arm and leg were analyzed.|4 weeks after the epidural injection||||Degrees Celsius||Standard Deviation|Mean
2603667|NCT02130258|Primary|Post-epidural Continued Pain Modulation (CPM)|CPM is a type of QST where the thermode is placed on the subject's non painful arm. Heat stimulation (47 degrees C, 4 seconds) was delivered to the thermode 4 times and the subject rated the pain felt by the heat stimulation on a visual analog scale (VAS) of 0-10. During the second heat stimulation, the subject immersed their hand (opposite from the arm with the thermode) in 12 degree C water and then rated the pain felt by the heat on a VAS of 0-10 (10 is the worst pain a subject can imagine, 0 is no pain). The final 2 heat stimuli were delivered (without using the hand submerged in water). This same test was repeated with the thermode on the subject's leg with radicular pain. The subject placed their hand contralateral to the painful leg in the cold water during the second heat stimulation. The VAS scores from each heat stimulation were averaged for the non-painful arm and the painful leg. The difference in averages between the arm and leg were then analyzed.|4 weeks after the epidural injection||||units on a scale||Standard Deviation|Mean
2603669|NCT02130193|Secondary|Number of Participants With Patient Global Impression of Change (PGIC)Score in Part B|Participants completed a PGIC questions at Week 4, 8, 16, 24, 40 and 52. Response options were on a 7 point Likert scale ranging from much better to much worse. PGIC was re-coded from a categorical to numerical value prior to analysis as: much worse = -3, worse = -2, slightly worse = -1, no change = 0, slightly better = 1, better = 2, much better = 3.A categorical summary of PGIC is presented by treatment and visit.Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Participants|||Number
2603670|NCT02130193|Secondary|Number of Participants With Patient Global Rating of Severity (PGRS) Score in Part B|PGRS is a single global question and was asked to participants to rate their COPD severity on a four point scale ranging from 1-4 (1=mild, 2=moderate, 3=severe, 4=very severe). Participants completed PGRS at Week 0, 4, 8, 16, 24, 40 and 52. Baseline was considered as score on Day 1. A categorical summary of PGRS is presented by treatment and visit.Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Participants|||Number
2603671|NCT02130193|Secondary|Number of Participants With Physician's Global Assessment (PGA) Readings in Part B|The PGA is a single item clinician reported outcome measure assessing the overall severity of COPD. Physicians rated disease severity on a four point scale ranging from 1-4 (1=mild, 2=moderate, 3=severe, 4=very severe) at Week 0, 4, 8, 16, 24, 40 and 52. Baseline was considered as score on Day 1. A categorical summary of PGA is presented by treatment and visit.Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Participants|||Number
2603672|NCT02130193|Secondary|Change From Baseline for COPD Assessment Test (CAT) at the Indicated Time Points in Part B|The CAT is a validated, 8 item questionnaire which has been developed designed to measure overall COPD-related health status for the initial assessment and longitudinal follow up of par. with COPD. Participants completed each question by rating their experience on a 6 point scale ranging from 0 (no impairment) to 5 (maximum impairment) with a total scoring range of 0 - 40. CAT was assessed at Baseline (Day 1), Day 28, Day 112, Day 168, Day 280 and Day 364 where Baseline was considered as score on Day 1. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Score on a scale||Standard Deviation|Mean
2603673|NCT02130193|Secondary|Monthly Weighted Means of EXACT-RS Domain Scores in Part B|EXACT-RS is a tool which consists of 11 items from the 14 item EXACT-PRO instrument, intended to capture information related to the respiratory symptoms of COPD. EXACT-RS domains included breathlessness, cough and chest symptoms. The EXACT-RS has a scoring range of 0-40, higher scores indicate more severe symptoms. A par. had at least 10 days of diary data in any month to contribute a non-missing weighted mean AUC of daily values; otherwise the weighted mean for that month were considered missing. A mixed effects model in a Bayesian framework with repeated measures were performed. The posterior mean and corresponding 95 percent credible interval were calculated. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Score on a scale||Standard Deviation|Mean
2603674|NCT02130193|Secondary|Assessment of Severity of EXACT-PRO Events in Part B|EXACT-PRO tool was used to measure severity of COPD exacerbations in participants. Severity was indicated by the maximum EXACT-PRO total score during the course of event (from day of onset to day of recovery).|Up to Day 392 in Part B|ITT Population|||Score on a scale||Standard Deviation|Mean
2603675|NCT02130193|Secondary|Assessment of Duration of EXACT-PRO Events in Part B|Duration is the length of time in days from onset to recovery. It was calculated as the difference in days between day of onset and day of recovery. Onset of event was identified as either an increase in EXACT-PRO score of >=12 points above the par. current mean Baseline for 2 consecutive days, with Day 1 of the 2 days serving as Day 1 onset of the event, or an increase of >=9 points above the par. current mean Baseline for 3 consecutive days, with Day 1 of the 3 days serving as Day 1 onset of the event. Duration was 3-day rolling average was used, which was initiated on Day 1 of onset and ended on Day 1 of Recovery. Recovery was defined as the first day in which par. experienced a persistent, sustained improvement in their condition i.e. decrease in the rolling average EXACT-PRO total score >=9 point from the maximum observed value (highest rolling average EXACT-PRO total score observed the first 14 days of the event) during the first 14 days of an event that is sustained for 7 days.|Up to Day 392 in Part B|ITT Population|||Days||Standard Deviation|Mean
2603676|NCT02130193|Secondary|Time to First EXACT-PRO Event in Part B|The hazard ratio for the DNX versus placebo comparison, along with 95% credible interval and posterior probability was derived and a Bayesian Cox proportional hazards model was used for statistical analysis. The analysis was performed on ITT Population. One participant was excluded from analysis.|Up to Day 392 in Part B|ITT Population|||Days||Standard Deviation|Mean
2603677|NCT02130193|Secondary|Time to First HCRU COPD Exacerbation in Part B|HCRU COPD exacerbations are defined as moderate or severe exacerbations based on requirement of new prescription antibiotics or oral corticosteroids, hospitalization or emergency room visits for management of COPD exacerbation. The time to the first on-treatment HRCU exacerbation were summarized by treatment group. It was analyzed using a Bayesian Cox proportional hazards model. The hazard ratio for the danirixin vs. placebo comparison, along with 95 percent credible interval, was derived, with terms for treatment group, smoking status and country. Posterior probabilities of the ratio of the percentage of par. with an HCRU exacerbation, adjusted for time to first exacerbation, in the danirixin group relative to the placebo group were calculated. 1 par. was excluded from analysis.|Up to Day 392 in Part B|ITT Population|||Days||Standard Deviation|Mean
2603687|NCT02130193|Primary|Maximum Observed Plasma Concentration (Cmax) of Danirixin in Part A|Cmax of danirixin was derived from the Pharmacokinetics (PK) samples collected at pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 14 in Part A. PK analysis of danirixin was conducted by non-compartmental methods. PK Concenteration Population comprised of par. in the ITT Population and who had provided at least one on-treatment blood sample for determination of danirixin concentration.|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 14 in Part A|PK Population|||Nanogram per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
2603678|NCT02130193|Secondary|Monthly Weighted Means of Exacerbations of EXACT-PRO Total Score in Part B|EXACT-PRO is a 14 item patient reported outcome instrument designed to capture information on the occurrence, frequency, severity, and duration of COPD exacerbations. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. A par. had at least 10 days of diary data in any month to contribute a non-missing weighted mean AUC of daily values; otherwise the weighted mean for that month were considered missing. A mixed effects model in a Bayesian framework with repeated measures were performed on the EXACT-PRO monthly weighted mean AUC data. The posterior mean and corresponding 95 percent credible interval were calculated. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Score on a scale||Standard Deviation|Mean
2603679|NCT02130193|Secondary|Number of EXACT-PRO Exacerbations Per Year in Part B|EXACT-PRO is a 14 item patient reported outcome instrument designed to capture information on the occurrence, frequency, severity, and duration of COPD exacerbations. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. For par. with less than 364 days on-treatment, the annual exacerbation rate was imputed as the number of recorded on-treatment exacerbations, divided by the number of 4-week treatment period intervals for which the par. was in the study, multiplied by 13. For par. with 364 or more days on-treatment, the annual exacerbation rate was calculated as the number of recorded exacerbations between study days 1 and 364. Statistical analysis was done using a Bayesian Cox model, assuming a negative binomial distribution for the underlying exacerbation rate. The exacerbation rates and the ratio (danirixin/placebo), were estimated and 95 percent credible intervals were produced using non-informative priors. 1 par. was excluded from analysis.|Up to Day 392 in Part B|ITT Population|||Exacerbations per year||Standard Deviation|Mean
2603680|NCT02130193|Secondary|AUC(0-12) of Danirixin in Part B|AUC (0-12) of danirixin was derived from the PK samples collected at pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 364; and at pre-dose and 2 hours on Day 28, 56 and 168 in Part B. PK analysis of danirixin was conducted by non-compartmental methods. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 364; and at pre-dose and 2 hours on Day 28, 56 and 168 in Part B|PK Population|||Hour*ng/mL||95% Confidence Interval|Geometric Mean
2603681|NCT02130193|Secondary|Tmax of Danirixin in Part B|Tmax of danirixin was derived from the PK samples collected at pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 364; and at pre-dose and 2 hours on Day 28, 56 and 168 in Part B. PK analysis of danirixin was conducted by non-compartmental methods. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 364; and at pre-dose and 2 hours on Day 28, 56 and 168 in Part B|PK Population|||Hour||Full Range|Median
2603682|NCT02130193|Secondary|Cmax of Danirixin in Part B|Cmax of danirixin was derived from the PK samples collected at pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 364; and at pre-dose and 2 hours on Day 28, 56 and 168 in Part B. PK analysis of danirixin was conducted by non-compartmental methods. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 364; and at pre-dose and 2 hours on Day 28, 56 and 168 in Part B|PK Population|||ng/mL||95% Confidence Interval|Geometric Mean
2603683|NCT02130193|Primary|Monthly Weighted Means of Exacerbations of Chronic Pulmonary Disease Tool-respiratory Symptoms (EXACT-RS) Total Score in Part B|EXACT-RS is a tool which consists of 11 items from the 14 item EXACT- patient reported outcomes (EXACT-PRO) instrument, intended to capture information related to the respiratory symptoms of COPD, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness. The EXACT-RS has a scoring range of 0-40, higher scores indicate more severe symptoms. A par. had at least 10 days of diary data in any month to contribute a non-missing weighted mean AUC of daily values; otherwise the weighted mean for that month were considered missing. A mixed effects model in a Bayesian framework with repeated measures were performed on the EXACT-RS monthly weighted mean AUC data. The posterior mean and corresponding 95 percent credible interval were calculated. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Score on a scale||Standard Deviation|Mean
2603684|NCT02130193|Primary|Number of Health Care Resource Utilization (HCRU) Defined COPD Exacerbations Per Year in Part B|HCRU COPD exacerbations are defined as moderate or severe exacerbations based on requirement of new prescription antibiotics or oral corticosteroids, hospitalization or emergency room visits for management of COPD exacerbation. For par. with less than 364 days on-treatment, the annual exacerbation rate was imputed as the number of recorded on-treatment exacerbations, divided by the number of 4-week treatment period intervals for which the par. was in the study, multiplied by 13. For par. with 364 or more days on-treatment, the annual exacerbation rate was calculated as the number of recorded exacerbations between study days 1 and 364. Statistical analysis was done using a Bayesian Cox model, assuming a negative binomial distribution for the underlying exacerbation rate. The exacerbation rates along with the ratio (danirixin/placebo), were estimated and corresponding 95 percent credible intervals were produced using non-informative priors. 1 par. was excluded from the analysis.|Up to Day 392 in Part B|ITT Population|||Exacerbations per year||Standard Deviation|Mean
2603685|NCT02130193|Primary|Area Under the Blood Concentration-time Curve (AUC) Over Dosing Interval (AUC[0-12]) of Danirixin in Part A|AUC (0-12) of danirixin was derived from the PK samples collected at pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 14 in Part A. PK analysis of danirixin was conducted by non-compartmental methods. A Bayesian random effects model was performed adjusting for the trial as a random effect. A non-informative normal prior distribution was used. Point estimates and corresponding 90 percent credible intervals were constructed.|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 14 in Part A|PK Population|||Hour*ng/mL||95% Confidence Interval|Geometric Mean
2603686|NCT02130193|Primary|Time of Occurrence of Cmax (Tmax) of Danirixin in Part A|Tmax of danirixin was derived from the PK samples collected at pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 14 in Part A. PK analysis of danirixin was conducted by non-compartmental methods.|Pre-dose and at 0.5, 1, 2, 4, 6, 8, 10 and 12 hour post-dose on Day 1 and Day 14 in Part A|PK Population|||Hour||Full Range|Median
2603688|NCT02130193|Primary|Change From Baseline in FEV1 and FVC at the Indicated Time Points in Part B|FEV1 and FVC were performed at Screening and on Day 1, 28, 56, 112, 168, 280, 364 and at Follow-up (Day 378 to 392) in Part B. FEV1 and FVC assessments at each time point (post-bronchodilator) were taken in triplicate. The maximum of the triplicate assessments were used. Baseline was considered as the measurement obtained at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Statistical analysis was performed using a repeated measures mixed effects model in a Bayesian framework. The estimate of the treatment difference and corresponding 95 percent credible interval was constructed for the difference between danirixin and placebo for each visit. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Liter||Standard Deviation|Mean
2603689|NCT02130193|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points in Part A|FEV1 measures how much air a person can exhale during a forced breath in 1 second. FVC is the total amount of air exhaled during the FEV test. FEV1 and FVC were performed at Screening and on Day 1, 14 and at Follow-up visit (Day 21 to 28). FEV1 and FVC assessments at each time point (post-bronchodilator) were taken in triplicate. The maximum of the triplicate assessments were used. Baseline was considered as the measurement obtained at Day 1 pre-dose. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Up to Day 28 in Part A|ITT Population|||Liter||Standard Deviation|Mean
2603690|NCT02130193|Primary|Change From Baseline in Urine Specific Gravity of Urine in Part B|Urinalysis including urine specific gravity was done at Screening and on Day 28, 168 and 364 in Part B. Baseline was considered as the measurement obtained at Screening (Day -1). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Up to Day 392 in Part B|ITT Population|||urine specific gravity||Standard Deviation|Mean
2603691|NCT02130193|Primary|Change From Baseline in Urine Specific Gravity of Urine in Part A|Urinalysis including urine specific gravity was done at Screening and Day 14 in Part A. Baseline was considered as the measurement obtained at Screening (Day -1). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Up to Day 28 in Part A|ITT Population|||urine specific gravity||Standard Deviation|Mean
2603692|NCT02130193|Primary|Change From Baseline in Urine pH in Part B|Urinalysis including urine pH was done at Screening and on Day 28, 168 and 364 in Part B. Baseline was considered as the measurement obtained at Screening (Day -1). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||pH||Standard Deviation|Mean
2603693|NCT02130193|Primary|Change From Baseline in Urine Power of Hydrogen (pH) at Day 14 in Part A|Urinalysis including urine pH was done at Screening and Day 14 in Part A. Baseline was considered as the measurement obtained at Screening (Day -1). The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.|Up to Day 28 in Part A|ITT Population|||pH||Standard Deviation|Mean
2603694|NCT02130193|Primary|Number of Participants With Urinalysis Dipstick Results in Part B|Test strip urinalysis was done for glucose, ketones, occult blood and protein at Screening and on Day 28, 168, 224 and 364 in Part B. Results were presented as negative, trace, 1+, 2+ and 3+ for glucose, ketones, occult blood and protein. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Participants|||Number
2603695|NCT02130193|Primary|Number of Participants With Urinalysis Dipstick Results in Part A|Test strip urinalysis was done for glucose, ketones, occult blood and protein at Screening and Day 14 in Part A. Results were presented as negative, trace, 1+, 2+ and 3+ for glucose, ketones, occult blood and protein. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 28 in Part A|ITT Population|||Participants|||Number
2603696|NCT02130193|Primary|Number of Participants With Clinical Chemistry Values of Potential Clinical Importance in Part B|Blood samples were collected at Screening and on Day 28, 168 and 364 in Part B to evaluate clinical chemistry parameters which included ALT, albumin, ALP, AST, total bilirubin, calcium, bicarbonate, chloride, creatinine, direct bilirubin, GGT, glucose, potassium, total protein, sodium, BUN and uric acid. Clinical chemistry values of potential clinical importance were presented as 'High' or 'Low' values based on the reference laboratory standards. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Participants|||Number
2603697|NCT02130193|Primary|Number of Participants With Clinical Chemistry Values of Potential Clinical Importance in Part A|Blood samples were collected at Screening and Day 14 in Part A to evaluate clinical chemistry parameters which included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), total bilirubin, calcium, bicarbonate, chloride, creatinine, direct bilirubin, gamma glutamyl transferase (GGT), glucose, potassium, total protein, sodium, blood urea nitrogen (BUN) and uric acid. Additional liver monitoring chemistry (ALT, AST, ALP and total and direct bilirubin) was done on Day 1 pre-dose. Clinical chemistry values of potential clinical importance were presented as 'High' or 'Low' values based on the reference laboratory standards.|Up to Day 28 in Part A|ITT Population|||Participants|||Number
2603698|NCT02130193|Primary|Number of Participants With Hematology Values of Potential Clinical Importance in Part B|Blood samples were collected at Screening and on Day 28, 168, and 364 in Part B to evaluate hematology parameters which included hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, MCHC, MCH, MCV, RBC count, WBC count, platelet count and reticulocyte count. Hematology values of potential clinical importance were presented as 'High' or 'Low' values based on the reference laboratory standards. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Participants|||Number
2603754|NCT02129556|Secondary|Disease Control Rate (DCR)|The proportion of patients with best confirmed RECIST response of CR, PR, or duration of SD of at least 24 weeks (measured from first dose of trial treatment).|From the start of trial treatment until confirmed CR, PR, or SD lasting for 24 weeks or longer||||proportion of participants||90% Confidence Interval|Number
2603699|NCT02130193|Primary|Number of Participants With Hematology Values of Potential Clinical Importance in Part A|Blood samples were collected at Screening and Day 14 in Part A to evaluate hematology parameters which included hemoglobin, hematocrit, basophils, eosinophils, lymphocytes, monocytes, neutrophils, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), red blood cell (RBC) count, white blood cell (WBC) count, platelet count and reticulocyte count. Hematology values of potential clinical importance were presented as 'High' or 'Low' values based on the reference laboratory standards.|Up to Day 28 in Part A|ITT Population|||Participants|||Number
2603700|NCT02130193|Primary|Number of Participants With Abnormal 12-lead ECG in Part B|12-lead ECG was taken on Day 1 pre-dose and on Day 28, 168 and at Follow-up (Day 378 to 392) in Part B using an ECG machine. Participants with abnormal-NCS and abnormal-CS findings were sumarized. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Participants|||Number
2603701|NCT02130193|Primary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) in Part A|12-lead ECG was taken on Day 1 pre-dose and on Follow-up visit (Day 21 to 28) in Part A using an ECG machine. Triplicate reading were taken on Day 1 pre-dose. Participants with abnormal-clinically not significant (NCS) and abnormal-clinically significant (CS) findings were sumarized.|Up to Day 28 in Part A|ITT Population|||Participants|||Number
2603702|NCT02130193|Primary|Number of Participants With Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Pulse Rate and Respiratory Rate Abnormalities of Potential Clinical Importance in Part B|Vital signs including SBP, DBP, pulse rate and respiratory rate were taken on Day 1 pre-dose and on Day 28, 56, 112, 168, 280, 364 and at Follow-up (Day 378 to 392) in Part B. Measurements were obtained in a semi-supine/ supine position after 5 minutes rest. The mean of replicate assessments at any given time point was used as the value for that time point. SBP <90 or >160 mmHg, DBP <40 or >110 mmHg, pulse rate <35 or >120 bpm and respiratory rate <8 or >30 breaths per minute were considered as values of potential clinical importance and were presented as 'High' or 'Low' values. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|Up to Day 392 in Part B|ITT Population|||Participants|||Number
2603703|NCT02130193|Primary|Number of Participants With Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Pulse Rate, Respiratory Rate and Body Temperature Abnormalities of Potential Clinical Importance in Part A|Vital signs including SBP, DBP, pulse rate, respiratory rate and body temperature were taken on Day 1 pre-dose and on Day 14 and at Follow-up (Day 21 to 28) in Part A. Measurements were obtained in a semi-supine/ supine position after 5 minutes rest. The mean of replicate assessments at any given time point was used as the value for that time point. SBP <90 or >160 millimeter of mercury (mmHg); DBP <40 or >110 mmHg, pulse rate <35 or >120 beats per minute (bpm) and respiratory rate <8 or >30 breaths per minute were considered as values of potential clinical importance and were presented as 'High' or 'Low' values. Intent-to-Treat (ITT) Population comprised of all randomized par. who received at least one dose of study medication.|Up to Day 28 in Part A|ITT Population|||Participants|||Number
2603704|NCT02130193|Primary|Number of Participants With Any AE and SAE in Part B|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention, events associated with liver injury and impaired liver function were categorized as SAE. Participants with AE or SAE occurrences >= 5 percent were summarized.|Up to Day 392 in Part B|All Subjects Population|||Participants|||Number
2603705|NCT02130193|Primary|Number of Participants With Any Adverse Event (AE) and, Serious Adverse Event (SAE) in Part A|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention, events associated with liver injury and impaired liver function were categorized as SAE. Participants with any AE or SAE were summarized. Participants with AE or SAE occurrences >= 5 percent were summarized. All Subjects Population comprised of all participants who were screened and for whom a record existed on the study database.|Up to Day 28 in Part A|All Subjects Population|||Participants|||Number
2603706|NCT02130063|Secondary|Change in Transferrin Saturation (TSAT)||From baseline to week 1, 2, 4, and 5||||percent||Standard Deviation|Mean
2603707|NCT02130063|Secondary|Change in Serum (s)-Ferritin Concentration||From baseline to week 1, 2, 4, and 5|FAS (N = 491): The FAS consisted of all subjects who were randomised, received at least one dose of the trial drug, and had at least one post-baseline Hb assessment.|||ng/mL||Standard Deviation|Mean
2603708|NCT02130063|Secondary|Change in Hb Concentration||From baseline to week 2, 4 and 5|FAS (N = 491): The FAS consisted of all subjects who were randomised, received at least one dose of the trial drug, and had at least one post-baseline Hb assessment.|||g/dL||Standard Deviation|Mean
2603709|NCT02130063|Primary|Number of Subjects With an Haemoglobin (Hb) Increase of ≥ 2 g/dL From Baseline at Any Time From Week 1 to Week 5|"The primary efficacy endpoint of the trial was the count of subjects with an Hb increase of ≥ 2 g/dL from baseline at any time from week 1 to week 5. 'Any time' implied that if the endpoint was met at a time-point prior to or at week 5, the effect (increase of ≥ 2 g/dL) did not have to be maintained throughout the trial in order for a subject to be a responder.~Number of responders (i.e. a subject with increase in Hb ≥ 2 g/dL from baseline at any time from week 1 to week 5) and percentages according to number of subjects in the analysis set were summarised."|From baseline to week 5|Full analysis set (FAS) (N = 491): The FAS consisted of all subjects who were randomised, received at least one dose of the trial drug, and had at least one post-baseline Hb assessment.|||participants|||Number
2603710|NCT02130024|Secondary|Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Flare|Anterior chamber flare was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. The presence of flare (increased protein levels) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. Proportion of patients is reported as a percentage. One eye (study eye) contributed to the analysis.|Baseline, Week 9|Safety Set. All patients who received at least one application of study treatment and had at least one post-baseline safety assessment, as treated. Descriptive statistics only.|||percentage of patients|||Number
2603711|NCT02130024|Secondary|Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Cells|Anterior cell grade was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. One eye (study eye) contributed to the analysis.|Baseline, Week 9|Safety Set. All patients who received at least one application of study treatment and had at least one post-baseline safety assessment, as treated. Descriptive statistics only.|||percentage of patients|||Number
2603712|NCT02130024|Secondary|Percentage of Patients With Change in Retinal Nerve Fibre Thickness From Baseline to Month 12 and Month 24|Retinal nerve fibre thickness was assessed using Optical Coherence Tomography (OCT) and measured in micrometers. A negative change in value (i.e. thinner nerve fibre) indicates nerve damage. One eye (study eye) contributed to the analysis.|Baseline, Month 12, Month 24|Safety Set. All patients who received at least one application of study treatment and had at least one post-baseline safety assessment, as treated. Descriptive statistics only.|||percentage of patients|||Number
2603713|NCT02130024|Secondary|Mean Change in Vascular Endothelial Growth Factor (VEGF) Plasma Concentration From Baseline to 7 Days After the Second and 7 Days After the Third Mandated Intravitreal Injection of Treatment|Blood for VEGF plasma concentration analysis was collected at Baseline and again at 7 days after the injection at Week 4 and 7 days after the injection at Week 8.|Baseline, Week 5, Week 9|FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
2603714|NCT02130024|Secondary|Mean Number of Times a Patient Needed to Return to Monthly Intravitreal Injections Over 24 Months|The number of times the patient returned to a monthly injection interval (from an extended interval) at least once during the 24-month study was calculated. One eye (study eye) contributed to the analysis.|Month 24|FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data. Descriptive statistics only.|||occurrences||Standard Deviation|Mean
2603715|NCT02130024|Secondary|Percentage of Patients Showing Less Than and Equal to 15 Letters Loss for BCVA From Baseline to Month 12 and to Month 24|Visual acuity was assessed with spectacles or other visual corrective devices in place using logMAR charts and recorded in number of letters correctly identified. A gain in letters correctly identified indicates an improvement in visual acuity, while a loss indicates a worsening. One eye (study eye) contributed to the analysis.|Baseline, Month 12, Month 24|FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.|||percentage of patients|||Number
2603716|NCT02130024|Secondary|Percentage of Patients Showing Greater Than and Equal to 15 Letters Gain for BCVA From Baseline to Month 12 and to Month 24|Visual acuity was assessed with spectacles or other visual corrective devices in place using logMAR charts and recorded in number of letters correctly identified. A gain in letters correctly identified indicates an improvement in visual acuity, while a loss indicates a worsening. One eye (study eye) contributed to the analysis.|Baseline, Month 12, Month 24|FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.|||percentage of patients|||Number
2603717|NCT02130024|Secondary|Percentage of Patients Showing no Intraretinal Fluid (IRF)/Subretinal Fluid (SRF)|Intraretinal fluid and subretinal fluid was assessed using Optical Coherence Tomography (OCT) and recorded as Present/Absent. One eye (study eye) contributed to the analysis.|Month 2, Month 12, Month 24|FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.|||percentage of patients|||Number
2603718|NCT02130024|Secondary|Mean Change in Central Subfield Foveal Thickness (CSFT) From Baseline to Month 12 and to Month 24|CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Optical Coherence Tomography (OCT) and measured in micrometers. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis|Baseline, Month 12, Month 24|FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.|||micrometers||Standard Deviation|Mean
2603719|NCT02130024|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 and to Month 24|Visual acuity was assessed with spectacles or other visual corrective devices in place using logMAR charts and recorded in number of letters correctly identified. BCVA change was defined as a change in letters correctly identified from the baseline assessment. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis|Baseline, Month 12, Month 24|FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.|||letters||Standard Deviation|Mean
2604290|NCT02121795|Secondary|Percentage Change From Baseline in Hip BMD at Week 96|Hip BMD was assessed by DXA scan.|Baseline; Week 96|Participants in the Hip DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2603721|NCT02130024|Secondary|Percentage of Patients With Newly Developed Geographic Atrophy During the Overall 24 Months of the Study|"Multimodal images of the eye were obtained by trained study site personnel and forwarded to an independent Central Reading Center. A patient was considered to have developed new GA if they did not have any GA at the start of the study period and were subsequently diagnosed with GA during the study period (diagnosis of GA change from No to Yes). The analysis of new GA development was restricted to only those subjects without GA reported at baseline. One eye (study eye) contributed to the analysis."|Baseline, Month 12, Month 24|FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.|||percentage of patients|||Number
2603722|NCT02130024|Secondary|Mean Change in Square-root Area of Geographic Atrophy From Baseline to Month 12|Multimodal images of the eye were obtained by trained study site personnel and forwarded to an independent Central Reading Center, where the area of GA was measured. Area was treated as zero if GA was reported as absent (Overall determination of GA presence). Mean change from baseline in GA area was reported in square root-transformed data (mm). One eye (study eye) contributed to the analysis.|Baseline, Month 12|FAS. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.|||mm||Standard Deviation|Mean
2603723|NCT02130024|Primary|Mean Change in Square-root Area of Geographic Atrophy (GA) From Baseline to Month 24|Multimodal images of the eye were obtained by trained study site personnel and forwarded to an independent Central Reading Center, where the area of GA was measured. Area was treated as zero if GA was reported as absent (Overall determination of GA presence). Mean change from baseline in GA area was reported in square root-transformed data (mm). One eye (study eye) contributed to the analysis.|Baseline, Month 24|All randomized patients with at least one post-baseline efficacy value for the primary endpoint (FAS). Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization, with no imputation for missing data.|||mm||Standard Deviation|Mean
2603724|NCT02129777|Secondary|Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score at Weeks 2, 4, 6, 10, and 12|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lunula, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||units on a scale||Standard Error|Least Squares Mean
2603725|NCT02129777|Secondary|Change From Baseline in EQ-5D-VAS Score at Week 12|"EQ-5D-VAS is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (Worst imaginable health state) to 100 mm (Best imaginable health state); higher scores indicate a better health state."|Baseline, Week 12|FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||millimeter (mm)||Standard Error|Least Squares Mean
2603726|NCT02129777|Secondary|Change From Baseline in EuroQoL Health Questionnaire (EQ-5D)- Index Score at Week 12|EQ-5D-Index score is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The score ranges from -0.594 to 1.000. The higher score indicates a better health state perceived by the participant.|Baseline, Week 12|FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||units on a scale||Standard Error|Least Squares Mean
2603727|NCT02129777|Secondary|Change From Baseline in Short Form 36 Health Survey (SF-36) at Week 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).|Baseline, Week 12|FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||units on a scale||Standard Error|Least Squares Mean
2603728|NCT02129777|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 12|"The DLQI is a 10-point rating scale for determining the impact of dermatological conditions on the participant's quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Maximum total score is 30, where 0-1 represents No effect at all on participant's life and 21-30 Extremely large effect on participant's life - higher scores indicating poorer quality of life."|Baseline, Week 12|FAS where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||units on a scale||Standard Error|Least Squares Mean
2603729|NCT02129777|Secondary|Change From Baseline in Duration of Morning Stiffness at Weeks 2, 4, 6, 10, and 12|Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Duration of stiffness was elicited in response to a standard question included in the portable device.|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||minutes||Standard Error|Least Squares Mean
2603755|NCT02129556|Secondary|Time to Progression (TTP)|Time to progression (TTP) defined as the interval between the dates of the start of trial treatment and first documentation of progressive disease. In the absence of documented progressive disease, follow-up will be censored at date of last disease assessment|From the first trial treatment until first documentation of progressive disease up to 24 weeks after stop of treatment (=30 months)||||months||90% Confidence Interval|Median
2603730|NCT02129777|Secondary|Change From Baseline in VAS Morning Stiffness Score at Weeks 2, 4, 6, 10, and 12|"Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Participants were asked to indicate their level of morning stiffness by marking a horizontal line with No stiffness at the left extreme and Very severe stiffness at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of stiffness experienced by the participant since waking on that particular day."|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||units on a scale||Standard Error|Least Squares Mean
2603731|NCT02129777|Secondary|Change From Baseline in VAS Joint Pain Score at Weeks 2, 4, 6, 10, and 12|"Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Participants were asked to indicate their severity of joint pain by marking a horizontal line with No pain at the left extreme and Worst pain imaginable at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of pain experienced during the previous 24 hours."|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||units on a scale||Standard Error|Least Squares Mean
2603732|NCT02129777|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Itching Score at Weeks 2, 4, 6, 10, and 12|"Assessments were performed using a portable electronic device, which was kept and used by the participant throughout the duration of the study. Participants were asked to indicate their level of itching by marking a horizontal line with No itch at the left extreme and Worst itch imaginable at the right extreme (scale ranging from 0 - 10, but not shown on the line). Each assessment was intended to capture the severity of itching experienced during the previous 24 hours."|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||units on a scale||Standard Error|Least Squares Mean
2603733|NCT02129777|Secondary|Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 6, 10, and 12|Assessment of BSA with psoriasis was performed by means of the palm method, where the palm of the participant's hand represented 1% of BSA. The affected areas were then calculated by their size compared to the participant's palm.|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||percentage of total body surface area||Standard Error|Least Squares Mean
2603734|NCT02129777|Secondary|Change From Baseline in sPGA Score at Weeks 2, 4, 6, 10, and 12|sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe).|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||units on a scale||Standard Error|Least Squares Mean
2603735|NCT02129777|Secondary|Percentage of Participants Achieving a sPGA Response of Clear (0) or Almost Clear (1) at Weeks 2, 4, 6, 10 and 12|sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe). 'Clear' and 'Almost clear' included all participants who had scored a 0 or 1.|Weeks 2, 4, 6, 10 and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||percentage of participants|||Number
2603736|NCT02129777|Secondary|Percentage of Participants Achieving Greater Than or Equal to (>=) 2 Point Improvement From Baseline in Static Physicians Global Assessment (sPGA) Score at Weeks 2, 4, 6, 10 and 12|sPGA for psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, plaque elevation and skin scaling across all psoriatic lesions. sPGA of psoriasis scale ranges from 0 (clear) to 5 (very severe). Participants who had >=2 point improvement are reported.|Weeks 2, 4, 6, 10 and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||percentage of participants|||Number
2603737|NCT02129777|Secondary|Percentage of Participants Achieving 90 Percent Reduction From Baseline PASI Score (PASI90 Response) at Weeks 2, 4, 6, 10 and 12|PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90-100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 90% reduction in PASI score relative to baseline PASI Score are reported.|Weeks 2, 4, 6, 10 and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||percentage of participants|||Number
2603753|NCT02129556|Secondary|Progression-Free Survival (PFS)|The interval between the dates of the first dose of trial treatment until first documentation of disease progression or death, whichever occurs first. Patients with new non-breast cancer malignancy must continue to be followed for progression of the original breast cancer. For patients without progression, follow-up is censored at the date of last disease assessment without progression, unless death occurs within 12 weeks following the date last known progression-free, in which case the death will be counted as a PFS event.|From the date of first treatment dose until documented disease progression or death from any cause. whichever occur first, assessed up to 30 months||||months||90% Confidence Interval|Median
2603738|NCT02129777|Secondary|Percentage of Participants Achieving 50 Percent Reduction From Baseline PASI Score (PASI50 Response) at Weeks 2, 4, 6, 10 and 12|PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90-100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 50% reduction in PASI score relative to baseline PASI Score are reported.|Weeks 2, 4, 6, 10 and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||percentage of participants|||Number
2603739|NCT02129777|Secondary|Change From Baseline in PASI Score at Weeks 2, 4, 6, 10, and 12|PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90-100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease.|Baseline, Weeks 2, 4, 6, 10, and 12|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||units on a scale||Standard Error|Least Squares Mean
2603740|NCT02129777|Secondary|Percentage of Participants Achieving 75 Percent Reduction From Baseline PASI Score (PASI75 Response) at Weeks 2, 4, 6, and 10|PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90-100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 75% reduction in PASI score relative to baseline PASI Score are reported.|Weeks 2, 4, 6 and 10|FAS where baseline and specified post-baseline assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||percentage of participants|||Number
2603741|NCT02129777|Primary|Percentage of Participants Achieving 75 Percent Reduction From Baseline Psoriasis Area and Severity Index (PASI) Score (PASI75 Response) at Week 12|PASI is an assessment of psoriasis lesion severity and affected body area combined into single score. The body was divided into 4 sections: head (h), trunk (t), upper (u) and lower (l) extremities. For each section, percent body surface area (A) involved was estimated: 0= No involvement to 6= 90-100 percent (%). Severity was estimated by clinical signs: erythema (E), induration (I), and desquamation (D); scale: 0= no symptoms to 4= very marked. Final PASI = 0.1(Eh + Ih + Dh)Ah + 0.3(Et + It + Dt)At + 0.2(Eu + Iu + Du)Au + 0.4(El + Il + Dl)Al where head: 0.1, upper extremities (arms): 0.2, trunk: 0.3, lower extremities (legs): 0.4 (corresponding to approximately 10%, 20%, 30%, and 40% of body surface area, respectively); total possible score range: 0= no disease to 72= maximal disease. Participants showing at least 75% reduction in PASI score relative to baseline PASI Score are reported.|Week 12|Full analysis set (FAS) where baseline and Week 12 assessment were available. FAS included all randomized and treated participants who had at least one valid post-baseline assessment of PASI in the double-blind period.|||percentage of participants|||Number
2603742|NCT02129725|Primary|Insulin-stimulated AKT Phosphorylation|"measured using Western blot for pAkt and for total Akt from muscle biopsies obtained at the end of the baseline hyperinsulinemic clamp and the three-month hyperglycemic clamp.~The ratio of pAkt to Akt expression was calculated at each time point and the change in ratio from 0 to 3 months is presented."|3 months||||change in ratio||Standard Deviation|Mean
2603743|NCT02129660|Secondary|Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 6||Baseline - Week 6|Participant|||Participants|||Count of Participants
2603744|NCT02129660|Secondary|Percentage of Subjects Who Had at Least 50% Reduction in Gravimetrically Measured Sweat Production From Baseline at Week 4||Baseline - Week 4|Participant|||Participants|||Count of Participants
2603745|NCT02129660|Primary|Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6||Baseline - Week 6|Participant|||mg/5 min||Standard Deviation|Mean
2603746|NCT02129660|Primary|Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4|Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject's axilla with the arm down by the subject's side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min.|Baseline - Week 4|Participant|||mg/5 min||Standard Deviation|Mean
2603747|NCT02129660|Primary|Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6||Baseline - Week 6|Participant|||Participants|||Count of Participants
2603748|NCT02129660|Primary|Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4||Baseline - Week 4|Participant|||Participants|||Count of Participants
2603749|NCT02129660|Primary|Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4|"HDSS is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects' condition based on how it affects daily activities.~1 (Best), 2, 3, 4 (Worst)"|Baseline - Week 4/ET|Participant|||Participants|||Count of Participants
2603756|NCT02129556|Secondary|Duration of Response (DoR)|Duration of response (DoR) is defined among patients with objective response (confirmed CR or PR as best overall response) as the interval between dates of first documentation of objective response and first documentation of progressive disease. In the absence of documented progressive disease, follow-up will be censored at date of last disease assessment.|From date of first documentation of objective response until first documentation of progressive disease, up to 24 weeks after stop of treatment (=30 months)|Patients who achieved objective response|||months||90% Confidence Interval|Median
2603757|NCT02129556|Primary|Objective Response Rate (ORR)|Confirmed CR or PR as best overall response. At the time of each restaging, patients will be classified as achieving complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or non-evaluable for response according to RECIST (Version 1.1) criteria.|Clinical and radiological tumor assessment will be performed by CT scan or MRI at baseline, at weeks 12, 18 and 24, then every 12 weeks until progression, or 24 weeks after stop of treatment if before progression.||||proportion of participants||90% Confidence Interval|Number
2603758|NCT02129556|Primary|Dose-Limiting Toxicity (DLT) of MK-3475 in Combination With Trastuzumab|"Determination of dose-limiting toxicity (DLT) which is defined as an adverse event or abnormal laboratory value assessed as suspected to be trial treatment related (possible, probable or definite) and unrelated to disease or disease progression. Toxicities and lab values will be graded according to the NCI CTCAE (v4.0).~Any grade-3 or greater non-hematological adverse event lasting at least one week;~Any grade-4 hematological toxicity; or,~Any adverse event resulting in a delay starting cycle 2 of more than 14 days."|Within the first 21 days|Patients enrolled during phase Ib portion, a patient receiving one or more doses of MK-3475 and trastuzumab is considered evaluable.|||Participants|||Count of Participants
2603759|NCT02129478|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|All early discontinuation of olanzapine or dose reduction cases will be reported.|Every day for 30 days after the last dose of the study drug||||Participants|||Count of Participants
2603760|NCT02129478|Secondary|Proportion of Patients With Complete CINV Control|The proportion of children achieving complete CINV control (no nausea, vomiting, or retching and no use of breakthrough antiemetic agents) during the acute (24 hours after the last dose of chemotherapy is administered) and delayed phases (the 7 days following the acute phase) will be described. The duration of assessment will depend on the number of days each individual patient receives chemotherapy. Nausea will be assessed using the Pediatric Nausea Assessment Tool (PeNAT).|During the acute (24 hours) and delayed (7 days after acute phase) phases, up to 2 weeks||||Participants|||Count of Participants
2603761|NCT02129478|Primary|Patient Outcomes|Our primary study outcome evaluated the feasibility of a future trial of olanzapine that would evaluate the contribution of olanzapine to chemotherapy-induced nausea and vomiting (CINV) control in pediatric oncology patients. A future trial was considered feasible if the following patient outcomes were met: mean time to enroll 15 patients was 12 months or less per site, 12 or more patients took at least half of the planned olanzapine doses, and 3 or less patients experienced significant sedation or dizziness despite dose reduction.|1 year||||Participants|||Count of Participants
2603762|NCT02129205|Secondary|Progression Free Survival and Overall Survival (Part 2)|Progression Free Survival was defined as the time from Cycle 1 Day 1 (C1D1) to first documentation of disease progression or to death due to any cause, whichever occurs first. Overall survival was defined as the time from initial dose until death from any cause, and is measured in the intent to treat population.|3 years|The study was prematurely terminated prior to the start of dose expansion phase (Part 2).||||||
2603763|NCT02129205|Secondary|Number of Participants With the Presence of Anti-PF-06650808 Antibodies (Part 1 and Part 2)|Assays to assess for anti drug (anti PF-06650808) antibodies (ADA) were performed. Positive ADA: titer>=1.88.|3 years|The analysis population included all participants who received at least 1 dose of study medication and had at least 1 post-dose ADA measurements. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).|||Participants|||Count of Participants
2603764|NCT02129205|Secondary|Terminal Elimination Half-Life (t1/2) (Part 1 and Part 2)|Terminal elimination half-life was defined as the time measured for the serum concentration to decrease by one half, and calculated as loge(2)/kel.|Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4|The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).|||hr||Standard Deviation|Mean
2603765|NCT02129205|Secondary|Volume of Distribution at Steady State (Vss) (Part 1 and Part 2)|Vss was calculated as dose/(AUCinf × kel), where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Vss was only for PF-06650808 (ADC) and Cycle 1.|Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1|The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).|||L||Geometric Coefficient of Variation|Geometric Mean
2603766|NCT02129205|Secondary|Clearance (CL) (Part 1 and Part 2)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL was calculated as dose/AUCinf, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time. CL was only for PF-06650808 (ADC) and Cycle 1.|Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1|The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2603767|NCT02129205|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) (Part 1 and Part 2)|Tau refers to the dosing interval, and it equals to 504 hours (3 weeks) of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were determined using linear/log trapezoidal method.|Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4|The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2603768|NCT02129205|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) (Part 1 and Part 2)|Tmax of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were observed directly from data as time of first occurrence.|Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4|The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).|||hr||Full Range|Median
2603769|NCT02129205|Secondary|Maximum Observed Serum Concentration (Cmax) (Part 1 and Part 2)|Maximum observed serum concentration (Cmax) of ADC (PF-06650808), total antibody (PF-06460005) and unconjugated payload (PF-06380101) were observed directly from data. PF-06650808 is comprised of an antibody (PF-06460005) and a cytotoxic agent (PF-06380101).|Pre-dose, 1, 4 and 24 hours post-dose, Days 4, 8 and 15 in Cycle 1 and Cycle 4|The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2603770|NCT02129205|Secondary|Number of Participants With Vital Signs Meeting Categorical Summarization Criteria (Part 1 and Part 2)|Vital Signs tests included systolic and diastolic blood pressure (BP) and pulse rate of seated supine and standing . Vital signs categorical summarization criteria were 1), supine and standing BP: systolic (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from baseline, diastolic <50 mm Hg; 2), supine and standing pulse rate <40 or greater than (>) 120 beats per minute (bpm).|3 years|The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).|||Participants|||Count of Participants
2603771|NCT02129205|Secondary|Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Urinalysis) (Part 1 and Part 2)|Urinalysis included urine protein. Microscopic analyses were performed if dipstick was abnormal. The participants who experienced laboratory test abnormalities were determined by investigators.|3 years|The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).|||Participants|||Count of Participants
2603772|NCT02129205|Secondary|Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Chemistries) (Part 1 and Part 2)|Chemistry evaluation included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, sodium, potassium, magnesium, chloride, calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose (non-fasted), albumin, phosphorus, bicarbonate or carbon dioxide, total protein and lactate dehydrogenase. The participants who experienced laboratory test abnormalities were determined by investigators.|3 years|The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).|||Participants|||Count of Participants
2603773|NCT02129205|Secondary|Number of Participants With Laboratory Abnormalities Without Regard to Baseline (Hematology) (Part 1 and Part 2)|Hematology evaluation included hemoglobin, platelets, white blood cell, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils and absolute basophils. The participants who experienced laboratory test abnormalities were determined by investigators.|3 years|The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).|||Participants|||Count of Participants
2603774|NCT02129205|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Part 1 and Part 2)|AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.|3 years|The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).|||Participants|||Count of Participants
2603775|NCT02129205|Primary|Percentage of Participants With Objective Response (Part 1 and Part 2)|Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A participant achieved complete response (CR) if both target and non-target lesions achieved CR, no new lesions; achieved partial response (PR) if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits. The overall objective response was defined as confirmed CR and PR.|Day 1 and every 6 weeks until disease progression, unacceptable toxicity, or up to 3 years|The analysis population included all participants who received at least 1 dose of study medication and had both baseline and at least 1 post-baseline tumor assessments. The study was prematurely terminated prior to the start of dose expansion phase (Part 2).|||Percentage of participants||95% Confidence Interval|Number
2603814|NCT02128763|Secondary|Change in Tear Film Break up Time, in Seconds|Average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. Possible range of scores is 0->20. Low values indicate greater severity. A positive change score = improvement.|12 months|Measure is eyes, not people.|||seconds|eyes|Standard Deviation|Mean
2603776|NCT02129205|Primary|Number of Participants With Dose-limiting Toxicities (DLT) (Part 1)|Severity of AEs (adverse events ) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs which were not considered related to disease progression occurring in the first cycle of treatment (21 days) were classified as DLTs: 1) Hematologic: Grade 4 neutropenia lasting >7 days; Febrile neutropenia; Grade>=3 neutropenia with infection; Any grade thrombocytopenia associated with clinically significant or life threatening bleeding; Grade 4 thrombocytopenia >=72 hours or platelets<=10,000/mm3 regardless of duration. 2) Non hematologic: Grade>=3 toxicities except those that had not been maximally treated; Delayed by more than 2 weeks in receiving the next scheduled cycle due to persisting toxicities not attributable to disease progression. 3) clinically important or persistent toxicities may have been considered a DLT following review by the Sponsor and the investigators.|Day 1 up to Day 21|The safety analysis set was used, which included all enrolled participants who received at least one dose of study medication.|||Participants|||Count of Participants
2603777|NCT02129192|Secondary|Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity After Single Administration of T80/A5/H12.5 mg FDC Tablet|Area under the concentration-time curve (AUC 0-infinity) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to extrapolated infinity after single administration of T80/A5/H12.5 mg FDC tablet|3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only|FEAS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2603778|NCT02129192|Secondary|Area Under the Concentration-time Curve (AUC 0-infinity) of the Analytes in Plasma Over the Time Interval From 0 to Extrapolated Infinity|Area under the concentration-time curve (AUC 0-infinity) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to extrapolated infinity|3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2603779|NCT02129192|Primary|Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration After Single Administration of T80/A5/H12.5 mg FDC Tablet|Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration after single administration of T80/A5/H12.5 mg FDC tablet|3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only|FEAS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2603780|NCT02129192|Primary|Area Under the Concentration-time Curve (AUC 0-tz) of the Analytes in Plasma Over the Time Interval From 0 to the Last Quantifiable Plasma Concentration|Area under the concentration-time curve (AUC 0-tz) of telmisartan, amlodipine and HCTZ in plasma over the time interval from 0 to the last quantifiable plasma concentration|3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2603781|NCT02129192|Primary|Maximum Measured Concentration (Cmax) of the Analytes in Plasma After Single Administration of T80/A5/H12.5 mg FDC Tablet|Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma after single oral administration of T80/A5/H12.5 mg FDC tablet|3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only|Food effect analysis set (FEAS) which included healthy subjects of treatment sequence TRRTT in the TS who were judged appropriate to continue to period 5 by the investigator, had evaluable PK variables for both feeding conditions and did not have an important protocol violation relevant to relative bioavailability evaluation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2603782|NCT02129192|Primary|Maximum Measured Concentration (Cmax) of the Analytes in Plasma|Maximum measured concentration (Cmax) of telmisartan, amlodipine and HCTZ in plasma|3 hours (h) pre drug admin and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug admin, in addition 15min, 30min, 45min, 1h 30min, 2h 30min for telmisartan and HCTZ only, 72h for telmisartan and amlodipine only and 96h, 120h, 144h for amlodipine only|Pharmacokinetic set (PKS) which included all healthy subjects in the TS who had evaluable PK variables for both treatments (i.e. had data of at least one analyte for both test and reference products) in periods 1, 2, 3 and 4. Subjects who had an important protocol violation relevant to PK evaluation were to be excluded from the PKS.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2603783|NCT02129062|Primary|Overall Survival Time|The time measurement from beginning treatment to recurrent or progressive disease is objectively documented. Overall survival time will be estimated using the Kaplan-Meier method. The two-sided log-rank test will be used to assess the differences of time to events between groups such as age groups, or Philadelphia chromosome-positive versus Philadelphia chromosome-negative B-ALL. Progressive disease is defined as a doubling of the peripheral blasts and an absolute increase of > 5 x 10^9/L.|Up to thirty days after after completion of study treatment anticipated to be 12 weeks for total of 16 weeks|Study terminated early due to slow enrollment, insufficient data . One participant was not evaluable due to early death, other two participants were removed from the study within 30 days of study start due to disease progression prior to scheduled treatment evaluations.||||||
2603797|NCT02128919|Other Pre-specified|Change From Baseline in Psychiatric Symptoms|The Positive and Negative Syndrome Scale (PANSS) was used to measure psychiatric symptoms. Item scores ranged from 1 (Absent) to 6 (Severe) for symptoms on the Positive Scale (total subscale range: 7-42), the Negative Scale (total subscale range: 7-42), and the General Psychopathology Scale (total subscale range:16-96). All three subscales were summed for the PANSS total score (total scale range: 30-180). Scores closer to 30 after baseline represented better outcomes. Here we report difference scores from post-treatment and baseline with negative difference scores representing better outcomes.|Baseline and after 5 tDCS sessions||||Units on a scale||Standard Deviation|Least Squares Mean
2603784|NCT02129062|Primary|Objective Response Rate (ORR)|ORR is defined as the proportion of participants with complete or partial response. Response definitions of Complete Response (CR): disappearance of leukemia as indicated by <5% marrow blasts & absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) >1000/μL & platelets >100,000/μL. C1 extramedullary disease status required. CR with incomplete count recovery (CRi): CR except with ANC <1000/μL and/or platelets <100,000/μL. Partial response (PR): improved or no worsening of ALL as indicated by no peripheral blood blasts, neutrophils >1000/μL, platelets >100,000μL, and either or both of the following: >50% decrease in marrow blast percentage, compared to pretreatment value, & marrow blast percentage ≥ 5% and ≤ 25%. C2 extramedullary disease status. Treatment failures are defined as participants who fail to achieve CR, CRi or PR.|3 months after treatment|One of three participants was not evaluable for response.|||percentage of participants|||Number
2603785|NCT02128997|Secondary|Postpartum Length of Stay||Until hospital discharge and then for 4 weeks follow up||||days||Inter-Quartile Range|Median
2603786|NCT02128997|Secondary|Tingling Pain Scores|On postoperative day 2, all patients were administered a pain scale: Rank tingling pain (0-10), 10 being worst possible tingling pain|Postpartum day 2||||Unit on a scale||Inter-Quartile Range|Median
2603787|NCT02128997|Secondary|Pain Scores|On postoperative day 2, all patients were administered a pain scale: Rank sharp pain (0-10), 10 being worst possible sharp pain.|Postpartum day 2||||Unit on a scale||Inter-Quartile Range|Median
2603788|NCT02128997|Primary|Number of Participants With Wound Complications|The primary outcome variable was a composite of wound morbidity at 4 weeks postpartum including SSI and/or wound opening|Four weeks after cesarean section||||Participants|||Count of Participants
2603789|NCT02128932|Secondary|Subjects Who Achieve HbA1c ≤6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE)|Subjects who achieve HbA1c ≤6.5% (48 mmol/mol), American Association of Clinical Endocrinologists (AACE) after 30 weeks of treatment|After 30 weeks treatment|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.|||Count of participants|||Number
2603790|NCT02128932|Secondary|Change in Patient Reported Outcome Questionnaires. (PROs), Diabetes Treatment Satisfaction Questionnaire (DTSQs)|The Diabetes Treatment Satisfaction Questionnaire (DTSQs) questionnaire was to be used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measured the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction. The values displayed are the estimated mean change from baseline to week 30.|Week 0, week 30|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.|||Score on a scale||Standard Error|Least Squares Mean
2603791|NCT02128932|Secondary|Change in Patient Reported Outcome (PRO) Questionnaire, Questionnaire SF-36v2™|The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL. PRO questionnaire (SF-36v2™) measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population. The (SF-36v2™) values displayed are the estimated mean change from baseline to week 30.|Week 0, week 30|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.|||T-scores||Standard Error|Least Squares Mean
2603792|NCT02128932|Secondary|Change in Systolic Blood Pressure.|Change in systolic blood pressure from baseline to week 30.|Week 0, week 30|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.|||mmHg||Standard Error|Least Squares Mean
2603793|NCT02128932|Secondary|Change in Diastolic Blood Pressure.|Change in diastolic blood pressure from baseline to week 30.|Week 0, week 30|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.|||mmHg||Standard Error|Least Squares Mean
2603794|NCT02128932|Secondary|Change in Fasting Plasma Glucose From Baseline|Change in fasting plasma glucose from baseline to week 30.|Week 0, week 30|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.|||mg/dL||Standard Error|Least Squares Mean
2603795|NCT02128932|Secondary|Change in Body Weight From Baseline|Change in body weight from baseline to week 30.|Week 0, week 30|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.|||Kg||Standard Error|Least Squares Mean
2603796|NCT02128932|Primary|Change in HbA1c From Baseline|Change in HbA1c from baseline to week 30.|Week 0, week 30|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomized semaglutide (s.c.) or insulin glargine. Subjects in the FAS contributed to the evaluation based on the treatment assigned at randomisation.|||percentage||Standard Error|Least Squares Mean
2603813|NCT02128763|Secondary|Change in Corneal Fluorescein Staining Score|Average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that quality that qualified for the study. Possible range of scores is 0-15; higher scores indicate more severity. A negative change indicates improvement.|12 months|Average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that quality that qualified for the study|||units on a scale|eyes|Standard Deviation|Mean
2603798|NCT02128919|Secondary|Change From Baseline in Cognitive Performance|The MATRICS Consensus Cognitive Battery (MCCB) was used to measure cognitive performance. Seven Domain scores and a Composite score are calculated by the proprietary MCCB Computer Scoring Program from raw scores on 10 individually administered subtests. We used the revised MCCB program (beta version) which allows for calculation of Domain and Composite scores with missing data. The Domain T-scores are percentile-ranked and range from <20 (<0.1 percentile) to >80 (>99.9 percentile). The Composite scores are also percentile-ranked and range from <213 (T<20, <0.1 percentile) to >487 (T>80, >99.9 percentile). Higher scores after baseline represent better outcomes. Here we report difference scores from post-treatment and baseline with positive difference scores representing better outcomes.|Baseline and 1-3 days (mean 1.8 [SD 1.4] days after 5 tDCS sessions( mean 8.7 days after baseline)||||MATRICS domain difference scores||Standard Deviation|Least Squares Mean
2603799|NCT02128919|Primary|Change From Baseline in Cigarette Craving|"The Brief Questionnaire on Smoking Urges (QSU-Brief) was used to measure cigarette cravings. Scores ranged from a minimum of 1 (Strongly Disagree) to a maximum of 7 (Strongly Agree) and were determined by self-reported responses to 10 statements about having cravings for smoking. Scores closer to 1 after treatment would indicate a better outcome. Responses to each of the 10 items in the scale were summed for one total score. With 10 items on this scale with a range of scores from 1 to 7, on each occasion of rating the minimum score would be 7 and the maximum score would be 70."|Baseline and after 5 tDCs sessions (mean time 8.7[SD 2.7] days after basleine)|Findings are based on31 subjects (15 active tDCS and 16 sham tDCS) who completed this QSU-Brief questionnaire in at baseline and after 5 tDCS sessions.. Complete sample who entered study and were randomized were 33 subjects 24 male and 9 female, but all subjects did not complete QSU brief rating scale..|||Units on QSU-Brief Scale||Standard Error|Least Squares Mean
2603800|NCT02128867|Other Pre-specified|Sa02|SaO2 will be measured during 15 minutes of treatment time|15 minutes|||||||
2603801|NCT02128867|Other Pre-specified|Heartrate|heartrate will be measured during 15 min of treatment time|15 minutes|||||||
2603802|NCT02128867|Secondary|Duration of Reflux Episodes|duration of reflux episodes will be measured during 15 min of treatment time|15 minutes|||||||
2603803|NCT02128867|Primary|Number of Refluxes|number of refluxes will be counted over a period of 15 minutes ( treatment time )|15 minutes||||number of refluxes||Standard Deviation|Mean
2603804|NCT02128763|Other Pre-specified|Change in Ocular Surface Cell HLA-DR Expression|Change is the average of values from 6 and 12 months minus average of the eligibility confirmation visits.|12 months||2021-01-31|01/2021||||
2603805|NCT02128763|Other Pre-specified|Change in Tear Cytokine Level|Change in levels of tear cytokines (inflammation). Change is the average of values from 6 and 12 months minus average of the eligibility confirmation visits.|12 months||2021-01-31|01/2021||||
2603806|NCT02128763|Other Pre-specified|Change in Tear Osmolarity|Tear osmolarity measures the salt content of the tears. Higher the osmolarity indicate more severe dry eye. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. A lower change score indicates improvement.|12 months|Each eye is measured separately. Total are number of eyes assessed, not subjects.Tear Osmolarity was only performed at the 18 clinical centers that owned a Tearlab osmolarity machine; therefore the number of participants analyzed for this measure is less than the overall number of study participants.|||mOsms/L|eyes|Standard Deviation|Mean
2603807|NCT02128763|Other Pre-specified|Change in Redness by Keratography|Change in ocular redness as measured using the keratograph machine. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits. Title of the Scale used to measure outcome: Oculus Keratograph 5M R-scan, Scale Ranges: 0.0-4.0. A lower number indicates a better outcome (less redness).|12 months|Each eye measured separately. Total are number of eyes assessed, not subjects. Change in redness measured by keratography was only performed at the 13 clinical centers that owned an Oculus Keratograph machine; therefore, the number of participants analyzed for this measure is less than the overall number of study participants.|||score on a scale|eyes|Standard Deviation|Mean
2603808|NCT02128763|Other Pre-specified|Change in Tear Meniscus Height( TMH) by Keratography|The purpose of the tear film is to reduce evaporation of natural tears. Assessment of the tear film meniscus is a quantitative measurement of tear film quantity. In this measure, TMH is measured using the keratograph machine. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits.|12 months|Each eye measured separately. Total are number of eyes assessed, not subjects. Tear Meniscus Height by Keratography was only measured at the 13 clinical centers that owned an Oculus Keratograph machine; therefore, the number of participants analyzed for this measure is less than the overall number of study participants.|||mm|eyes|Standard Deviation|Mean
2603809|NCT02128763|Other Pre-specified|Change in Tear Break up Time by Keratography|Tear breakup time (TBUT) is used to assess for evaporative dry eye disease. In this measure, TBUT is measured using the keratograph machine. TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film. Change is the average of values from 6 and 12 months minus average of values from screening and eligibility confirmation visits.|12 months|Each eye is measured separately. Total are number of eyes assessed, not subjects. Tear Break up Time by Keratography was only measured at the 13 clinical centers that owned an Oculus Keratograph machine; therefore the number of participants analyzed for this measure is less than the overall number of study participants.|||seconds|eyes|Standard Deviation|Mean
2603810|NCT02128763|Other Pre-specified|Change in Intraocular Pressure (IOP)- mm Hg|Eye pressure is measured in millimeters of mercury (mm Hg). Normal eye pressure ranges from 12-22 mm Hg, and eye pressure of greater than 22 mm Hg is considered higher than normal. Included as a safety measure.|12 months|Each eye measured separately|||mmHg|eyes|Standard Deviation|Mean
2603811|NCT02128763|Secondary|Change in Use of Artificial Tears and Other Treatments for Dry Eye Disease|Subjects with change in number of treatments used for dry eye disease, n.,(%)|12 months|Data are missing for 5 subjects in the omega -3 group and 6 subjects in the placebo group|||Participants|||Count of Participants
2603812|NCT02128763|Secondary|Change in Visual Acuity|Visual acuity scores of 0-100 correspond to Snellen visual acuity levels of worse than 20/800 to 20/10, respectively. Higher change score = improved visual acuity.|12 months|Each eye measured separately. Total are numbers of eyes assessed, not subjects.|||score on a scale|eyes|Standard Deviation|Mean
2603815|NCT02128763|Secondary|Change in Schirmer's Test mm|The Schirmer's test measures the production of tears by an eye as measured by mm of wetting of a strip of paper attached to the lower lid for 5 minutes. Scores range from 0 to 30 or more mm. Lower scores indicate more severe dry eye. Change is the average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that qualified for the study.|12 months|among eligible eyes|||mm|eyes|Standard Deviation|Mean
2603816|NCT02128763|Secondary|Change in Conjunctival Staining Score|Average change from 6 and 12 months minus average of values from screening and eligibility confirmation visits among eyes that qualified for the study. Scores range between 0-6, with higher scores indicate more severity. A negative change indicates improvement.|12 months|Among eyes that qualified for the study.|||units on a scale|eyes|Standard Deviation|Mean
2603817|NCT02128763|Secondary|Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of Oleic Acid|Change in Oleic Acid (from olive oil) levels in red blood cells - percentage points. Change is the average score at 6 and 12 months minus the average score at eligibility confirmation visit. (Blood was not drawn at the screening visit.) Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group because blood was not drawn.|12 months|Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group|||percentage of oleic acid in blood cells||Standard Deviation|Mean
2603818|NCT02128763|Secondary|Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of DHA|Change in DHA levels in red blood cells - percentage points. Change is the average score at 6 and 12 months minus the average score at eligibility confirmation visit (blood was not drawn at the screening visit. If compliant, higher DHA levels in red blood cells in the Omega 3 group is expected and no change is expected in the placebo group. Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group.|12 months|Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group.|||percentage of fatty acids in blood cells||Standard Deviation|Mean
2603819|NCT02128763|Secondary|Compliance With the Study Treatment Protocol as Measured by Change in Blood Levels of EPA|Change in EPA levels in red blood cells - percentage points. Change is the average level at 6 and 12 months minus the level at the eligibility confirmation visit. (Blood was not drawn at the screening visit.) If subjects are compliant, higher EPA levels in red blood cells in the Omega 3 group are expected and no change is expected in the placebo group. Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group because blood was not drawn at the visit.|12 months|Data are missing for 20 subjects in the Omega 3 group and 15 subjects in the placebo group.|||percentage of fatty acids in blood cells||Standard Deviation|Mean
2603820|NCT02128763|Secondary|Change From Baseline in SF-36 Mental Health Subscale|Medical Outcomes Study 26--Item Short Form Health Survey (SF-36) Mental Health Subscale. Mental Health subscale range is 0-100 with higher scores indicating better self reported mental health. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A positive change score = improvement.|12 months||||score on a scale||Standard Deviation|Mean
2603821|NCT02128763|Secondary|Change From Baseline in SF-36 Physical Health Subscale|Medical Outcomes Study 36--Item Short Form Health Survey (SF-36) Physical Health Subscale. Subscale range is 0-100, with higher scores indicating better self reported physical health-related quality of life. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A positive change score = improvement.|12 months||||score on a scale||Standard Deviation|Mean
2603822|NCT02128763|Secondary|Change in Brief Ocular Discomfort Index (BODI) Pain Interference Subscale|Brief Ocular Discomfort Index (BODI) Pain Interference subscale scores range from 0 to 100, with higher scores indicating greater discomfort. Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. A negative change score = improvement.|12 months||||score on a scale||Standard Deviation|Mean
2603823|NCT02128763|Secondary|Greater Than or Equal to 10 Point Decrease in Ocular Surface Disease Index (OSDI) (at Least 10 Point Improvement in Symptoms)|Number of participants with at least a 10 point decrease from baseline in Ocular Surface Disease Index (OSDI). Change is the average score at 6 and 12 months minus the average score at the screening and eligibility confirmation visits. OSDI scores range from 0 to 100, with a score of 0 indicating no ocular discomfort and higher scores indicating greater symptom severity. A negative change score = improvement.|12 months||||Participants|||Count of Participants
2603824|NCT02128763|Primary|Mean of Change From Baseline in Ocular Surface Disease Index (OSDI) Score at 6 and 12 Months|Average of Ocular Surface Disease Index (OSDI) scores from 6 and 12 months minus average of values from screening and eligibility confirmation visits. OSDI scores range from 0 to 100, with a score of 0 indicating no ocular discomfort and higher scores indicating greater symptom severity. The minimal clinically meaningful change in score is 10 points.|12 months||||units on a scale||Standard Deviation|Mean
2603825|NCT02128724|Other Pre-specified|Measure Tumour PRAS40 Levels|Exploratory studies will aim to correlate response to BKM120 with activation of specific molecular pathways present in the archived, diagnostic, tumour biopsy sample.|Archival sample taken before trial entry|Where possible, tissue was obtained from the trial participants' clinical diagnostic samples.|||Participants|||Count of Participants
2603826|NCT02128724|Other Pre-specified|Measure Tumour PTEN (Phosphatase and Tensin Homolog Gene) Levels|Exploratory studies aimed to correlate response to buparlisib with activation of specific molecular pathways present in the archived, diagnostic, tumour biopsy sample.|Archival sample taken before trial entry|Where possible, tissue was obtained from trial participants' diagnostic samples.|||Participants|||Count of Participants
2603827|NCT02128724|Other Pre-specified|Determine Phosphorylation Status of Akt in Peripheral Blood Mononuclear Cells (PBMCs)|"The levels of phospho-Akt expression in normal tissues may reflect the efficacy of BKM120. Changes in phospho-Akt expression will be monitored during the trial using PBMCs taken during the trial.~Reductions in phospho-Akt expression of PBMC's following BKM120 treatment were to be correlated with changes observed with the functional imaging investigations; however it was not possible to draw any meaningful conclusions due to huge inter- and intra- participant variability seen on staining (no scoring was performed)."|Baseline, days 8, 14, 28 and 56|No scoring was performed, as on staining it was determined that the inter- and intra- participant variability seen would prevent any meaningful conclusions from being drawn.||||||
2603828|NCT02128724|Secondary|Percentage Change in Mean Transit Time as Detected by Perfusion CT at Days -1 and 8|Perfusion CT is a technique used to study the vasculature within tumours and other tissues. It is non-invasive and readily incorporated into existing CT protocols using conventional contrast agents. A perfusion CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour physiology (blood flow) due to buparlisib treatment, and the % change between the 2 scans was calculated.|Days -1 and 8|The tumour perfusion analysis involved all patients who had a pair of interpretable pCT scans.|||% change in seconds||Inter-Quartile Range|Median
2603829|NCT02128724|Secondary|Mean Transit Time as Detected by Perfusion CT at Days -1 and 8|Perfusion CT is a technique used to study the vasculature within tumours and other tissues. It is non-invasive and readily incorporated into existing CT protocols using conventional contrast agents. A perfusion CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour physiology (blood flow) due to buparlisib treatment.|Days -1 and 8|The tumour perfusion analysis involved all patients who had a pair of interpretable pCT scans.|||seconds||Inter-Quartile Range|Median
2603830|NCT02128724|Secondary|Blood Volume at Day -1 and Day 8 as Detected by Perfusion CT|Perfusion CT is a technique used to study the vasculature within tumours and other tissues. It is non-invasive and readily incorporated into existing CT protocols using conventional contrast agents. A perfusion CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour physiology due to buparlisib treatment|Days -1 and 8|The tumour perfusion analysis involved all patients who had a pair of interpretable pCT scans.|||mL/100g||Inter-Quartile Range|Median
2603831|NCT02128724|Secondary|Percentage Changes in Blood Volume Between Day -1 and Day 8 as Detected by Perfusion CT|Perfusion CT is a technique used to study the vasculature within tumours and other tissues. It is non-invasive and readily incorporated into existing CT protocols using conventional contrast agents. A perfusion CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour physiology due to buparlisib treatment, and the % change between the 2 scans calculated.|Days -1 and 8|The tumour perfusion analysis involved all patients who had a pair of interpretable pCT scans.|||% change in mL/100g||Inter-Quartile Range|Median
2603832|NCT02128724|Secondary|Tumour-to-blood Volume Ratio Percentage Changes Between Day -1 and Day 8 in 18F-Misonidazole Uptake as Detected by PET-CT Scans, to Investigate if Buparlisib Alters Hypoxia|"18F-Miso is a radiotracer that selectively accumulates in hypoxic tissues. 18F-Miso PET-CT scans are able to non-invasively image tumour hypoxia. A 18F-Miso PET-CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour hypoxia due to buparlisib treatment. The percentage change between the TBR volume for the 1st and 2nd scans was calculated.~TBR volume is measured by summing the number of tumour/node/metastases voxels with a value greater than or equal to 1.4.~Hypoxia was measured using TBRmean and TBRvolume (tumour-to-blood ratio mean, tumour-to-blood ratio volume)."|Days -1 and 8|The tumour hypoxia analysis involved all patients who had a pair of interpretable PET scans.|||% change in tumour to blood volume ratio||Inter-Quartile Range|Median
2603833|NCT02128724|Secondary|Tumour-to-blood Mean Ratio in 18F-Misonidazole Uptake as Detected by PET-CT Scans, to Investigate if Buparlisib Alters Hypoxia|"18F-Miso is a radiotracer that selectively accumulates in hypoxic tissues. 18F-Miso PET-CT scans are able to non-invasively image tumour hypoxia. A 18F-Miso PET-CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour hypoxia due to buparlisib treatment.~Hypoxia was measured using TBRmean and TBRvolume (tumour-to-blood ratio mean, tumour-to-blood ratio volume).~TBR mean is measured by dividing all tumour/node/metastases voxels by the mean value of the descending aorta activity concentration."|Days -1 and 8|The tumour hypoxia analysis involved all patients who had a pair of interpretable PET scans.|||Tumour to blood mean ratio||Inter-Quartile Range|Median
2603834|NCT02128724|Secondary|Percentage Change in Blood Flow as Detected by Perfusion CT at Days -1 and 8|Perfusion CT is a technique used to study the vasculature within tumours and other tissues. It is non-invasive and readily incorporated into existing CT protocols using conventional contrast agents. A perfusion CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour physiology (blood flow) due to buparlisib treatment, and the percentage change between both scans calculated.|Days -1 and 8|The tumour perfusion analysis involved all patients who had a pair of interpretable pCT scans.|||% change in mL/100g/min||Inter-Quartile Range|Median
2603835|NCT02128724|Secondary|Changes in Blood Flow as Detected by Perfusion CT: Response|Perfusion CT is a technique used to study the vasculature within tumours and other tissues. It is non-invasive and readily incorporated into existing CT protocols using conventional contrast agents. A perfusion CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour physiology due to buparlisib treatment. For tumour perfusion, a patient is classified as 'responder' if blood flow (BF) and/or blood volume (BV) is increased and/or mean transit time (MTT) is reduced from baseline measurements by more than 25%.|Days -1 and 8|The tumour perfusion analysis involved all patients who had a pair of interpretable pCT scans.|||Participants|||Count of Participants
2603836|NCT02128724|Secondary|Tumour-to-blood Volume Ratio in 18F-Misonidazole Uptake as Detected by Day -1 and Day 8 PET-CT Scans, to Investigate if Buparlisib Alters Hypoxia|"18F-Miso is a radiotracer that selectively accumulates in hypoxic tissues. 18F-Miso PET-CT scans are able to non-invasively image tumour hypoxia. A 18F-Miso PET-CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment.~Tumour to blood volume ratio (TBR volume) is measured by summing the number of tumour/node/metastases voxels with a value greater than or equal to 1.4."|Days -1 and 8|The tumour hypoxia analysis involved all patients who had a pair of interpretable PET scans.|||Tumour to blood volume ratio||Inter-Quartile Range|Median
2603837|NCT02128724|Secondary|Blood Flow at Days -1 and 8 as Detected by Perfusion CT|Perfusion CT is a technique used to study the vasculature within tumours and other tissues. It is non-invasive and readily incorporated into existing CT protocols using conventional contrast agents. A perfusion CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour physiology due to buparlisib treatment.|Days -1 and 8|The tumour perfusion analysis involved all patients who had a pair of interpretable pCT scans.|||mL/100g/min||Inter-Quartile Range|Median
2603838|NCT02128724|Secondary|Changes in 18F-Misonidazole Uptake as Detected by PET-CT Scans: Response|18F-Miso is a radiotracer that selectively accumulates in hypoxic tissues. 18F-Miso PET-CT scans are able to non-invasively image tumour hypoxia. A 18F-Miso PET-CT scan was conducted prior to commencing buparlisib and repeated prior to commencing radiotherapy treatment to identify changes in tumour hypoxia due to buparlisib treatment. For tumour hypoxia, a patient is classified as a 'responder' if there is evidence of a 10% or greater reduction in retained F-Misonidazole. Hypoxia was measured using TBRmean or TBRvolume (tumour-to-blood ratio).|Days -1 and 8|The tumour hypoxia analysis involved all patients who had a pair of interpretable 18F-Miso PET scans.|||Participants|||Count of Participants
2603839|NCT02128724|Primary|Safety and Tolerability Analysis: Patients With Buparlisib Related Adverse Events|Adverse events (AEs) and Serious Adverse Events (SAEs) were also analysed for frequency. For further details, please consult the AEs/SAEs section.|8 weeks (10 weeks cohort 4 - this cohort was not opened)|The safety and tolerability post-treatment analysis was based on all patients who received at least one MTD dose of buparlisib (n = 21).|||Participants|||Count of Participants
2603840|NCT02128724|Primary|Dose Escalation Analysis: Number of DLTs Observed in Evaluable Patients|"The maximum tolerated dose (MTD) was defined as the highest dose at which no more than 1 of 6 evaluable patients or 0 of 3 evaluable patients experience a dose limiting toxicity (DLT). The study was carried out using a 3+3 dose escalation design.~DLTs were defined per NCI CTCAE v 4.0. The following were considered DLT if they occur at any point whilst the patient is on study: 1) Any ≥ grade 3 non-haematological toxicity (excluding nausea, vomiting or diarrhoea) that requires hospital admission or which does not resolve to ≤ grade 2 within 7 consecutive days of optimal treatment. 2) Any ≥ grade 3 nausea, vomiting or diarrhoea will be considered DLT only if any of them persist for >48 hours despite maximum supportive care. 3) ≥ Grade 3 pneumonitis 4) Any ≥ Grade 4 haematological toxicity. 5) Mood deterioration from baseline. DLT will be any grade ≥3 mood change if BL score of 2. DLT will be any grade ≥2 mood change if baseline score of ≤ 1."|8 weeks (10 weeks cohort 4 - this cohort was not opened)|The Primary Dose Escalation analysis (the declaration of MTD) included all patients completing 14 days of buparlisib treatment and 56 days of evaluation or patients who withdrew early after experiencing DLT.|||Participants|||Count of Participants
2603841|NCT02128542|Secondary|Number of Participants With Nonstructural Protein 5B (NS5B) Nucleoside Inhibitor (NI) Resistance-Associated Variants (RAVs) and RBV RAVs at Pretreatment and Posttreatment|Deep sequencing of the HCV NS5B gene was attempted for all participants who had virologic failure at pretreatment and posttreatment time points if the level of HCV RNA in the plasma sample was ≥ 1000 IU/L.|Pretreatment and Posttreatment Week 12|Participants who relapsed and qualified for sequencing analysis were analyzed.|||participants|||Number
2603842|NCT02128542|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period after having achieved HCV RNA < LLOQ at end of treatment.|Up to Posttreatment Week 12|"Participants in the Full Analysis Set with available data were analyzed~."|||Percentage of participants|||Number
2603843|NCT02128542|Secondary|Percentage of Participants Experiencing Viral Breakthrough|"Viral breakthrough was defined as either:~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment~HCV RNA ≥ LLOQ at the last available on-treatment measurement with no subsequent follow-up values"|Up to Posttreatment Weak 12|Full Analysis Set|||Percentage of participants|||Number
2603844|NCT02128542|Secondary|Percentage of Participants With Sustained Virologic Response at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug.|Posttreatment Week 4|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2603845|NCT02128542|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who received at least 1 dose of study drug|||Percentage of participants|||Number
2603846|NCT02128542|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug|||Percentage of participants||95% Confidence Interval|Number
2603847|NCT02128490|Secondary|Percentage of Participants With Serum Urate <6.0 mg/dL at Month 3||Month 3|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL.|||percentage of participants|||Number
2603848|NCT02128490|Secondary|Percentage of Participants With at Least One Gout Flare Requiring Treatment|"A participant was considered to have a gout flare if the following criteria were met:~Participant-reported acute particular pain typical of a gout attack that was deemed by participant and/or investigator to require treatment and was treated with colchicine, nonsteroidal anti-inflammatory drugs (NSAIDs) or steroids, Participant experienced at least 3 or more of: 1) Joint swelling, 2) Redness, 3) Tenderness, 4) Pain, Participant experienced at least one or more of: 1) Rapid onset of pain, 2) Decreased range of motion, 3) Joint warmth, 4) Other symptoms similar to a prior gout flare."|Baseline to Month 3|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.|||percentage of participants|||Number
2603849|NCT02128490|Primary|Percentage of Participants With Serum Urate <5.0 mg/dL at Month 3||Month 3|Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of double-blind study medication. Participants who discontinued double-blind study drug prior to the Month 3 visit were considered treatment failures, i.e. to have serum urate ≥ 5.0 mg/dL.|||percentage of participants|||Number
2603850|NCT02128269|Primary|Safety and Tolerability of Intravenous (IV) ALXN1007 as Measured by Percentage of Patients Reporting Adverse Events||Treatment Period (24 weeks)||||Participants|||Count of Participants
2603851|NCT02128217|Secondary|Concentration of Tenofovir (TFV) in Plasma|Concentration of tenofovir (TFV) in plasma among participants who took TFV for treatment of HIV infection.|Baseline (before HCV study treatment), EOT (end of trial dosing), 12 weeks after end of HCV study treatment. The duration of HCV study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.|Participants who started first dose of study treatment and also took tenofovir (TFV) for treatment of HIV infection.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2603852|NCT02128217|Secondary|Concentration of Tenofovir Diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cells (PBMCs)|Concentration of tenofovir diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs). This outcome is measured in Cohort 1 only.|Baseline (before SOF + RBV dosing), EOT (end of study treatment), 12 weeks after end of HCV study treatment.|Participants in Cohort 1 who successfully enrolled and received first dose of SOF + weight-based RBV and who were also taking tenofovir disoproxil fumarate (TDF) for treatment of HIV infection.|||fmol/10^6 cells||Geometric Coefficient of Variation|Geometric Mean
2603853|NCT02128217|Secondary|Cellular Concentration of Tenofovir Diphosphate (TFV-DP)|Cellular concentration of tenofovir diphosphate (TFV-DP) from dried blood spot samples.|Baseline (before HCV study treatment), EOT (end of trial dosing), 12 weeks after end of HCV study treatment. The duration of HCV study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.|Participants who started first dose of study treatment and also took tenofovir disoporxil fumarate (TDF) for treatment of HIV infection.|||fmol/punch||Geometric Coefficient of Variation|Geometric Mean
2603854|NCT02128217|Secondary|Ribavirin Concentration in Plasma|Ribavirin concentration in plasma. This outcome was evaluated in Cohort 1 only.|4, 8, and 12 weeks after starting study treatment.|Participants in Cohort 1 who successfully enrolled and received first dose of SOF + weight-based RBV.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2603855|NCT02128217|Secondary|Adherence as Measured by LDV/SOF Pill Count|The count and percentage of participants who had a pill count consistent with 100% of LDV/SOF doses taken.. This outcome measure was evaluated in Cohort 2 only.|8 weeks after starting study treatment.|Participants in Cohort 2 who successfully enrolled and received first dose of LDV/SOF.|||Participants|||Count of Participants
2603856|NCT02128217|Secondary|Self-reported Adherence to LDV/SOF|Count and percentage of participants who reported having taken all doses of LDV/SOF. This outcome measure was evaluated in Cohort 2 only.|1, 2, 4, and 8 weeks after starting study treatment.|Participants in Cohort 2 who successfully enrolled and received first dose of LDV/SOF.|||Participants|||Count of Participants
2603857|NCT02128217|Secondary|Adherence as Measured by RBV Pill Count|The count and percentage of participants who had a pill count consistent with 100% of RBV doses taken. This outcome measure was evaluated in Cohort 1 only.|12 weeks after starting study treatment.|Participants in Cohort 1 who successfully enrolled and received first dose of SOF + weight-based RBV.|||Participants|||Count of Participants
2603858|NCT02128217|Secondary|Self-reported Adherence to RBV|Count and percentage of participants who reported having taken all doses of RBV. This outcome measure was evaluated in Cohort 1 only.|1, 2, 4, 8 and 12 weeks after starting study treatment.|Participants in Cohort 1 who successfully enrolled and received first dose of SOF+weight-based RBV.|||Participants|||Count of Participants
2603859|NCT02128217|Secondary|Adherence as Measured by SOF Pill Count|The count and percentage of participants who had a pill count consistent with 100% of SOF doses taken. This outcome measure was evaluated in Cohort 1 only.|12 weeks after starting study treatment.|Participants in Cohort 1 who successfully enrolled and received first dose of SOF+weight-based RBV.|||Participants|||Count of Participants
2603860|NCT02128217|Secondary|Self-reported Adherence to SOF|Count and percentage of participants who reported having taken all doses of SOF. This outcome measure was evaluated in Cohort 1 only.|1, 2, 4, 8 and 12 weeks after starting study treatment.|Participants in Cohort 1 who successfully enrolled and received first dose of SOF+weight-based RBV.|||Participants|||Count of Participants
2603861|NCT02128217|Secondary|Change in CD4+ Cell Count|The change in CD4+ cell count from baseline to 12 weeks after the end of study treatment.|Baseline to 12 weeks after end of study treatment. Duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.|Participants who successfully enrolled and recieved first dose of treatment.|||cells/mm^3||Standard Deviation|Mean
2603862|NCT02128217|Secondary|Count of Participants With HIV-1 RNA <50 Copies/mL|Because all except one participant had HIV-1 RNA < 50 copies/mL, participants were categorized according to whether or not their HIV-1 RNA was <5 copies/mL at each follow-up evaluation.|4 and 12 weeks after start of study treatment for Cohort 1. 4 and 8 weeks after start of study treatment for the 8-week regimen used in Cohort 2)|Participants who enrolled successfully, received HIV ARV regimen at entry and started first dose of treatment|||Participants|||Count of Participants
2603863|NCT02128217|Secondary|Count and Percentage of Participants With an Adverse Event by Type.|The adverse events considered were Grade 2 or higher adverse events (primary diagnosis, primary sign and symptom, or a primary lab), SAE according to ICH criteria, or treatment-limiting adverse events. Participants may experience more than one type of adverse event.|Any time from start of treatment to 28 days after date of last dose of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.|Participants who successfully enrolled and received first dose of treatment.|||Participants|||Count of Participants
2603864|NCT02128217|Secondary|Percentage of HCV Virologic Failure Participants That Developed SOF- or LDV-Associated Resistance Mutations|Percentage of participants who developed SOF- or LDV-associated resistance mutation found within HCV Virologic Failure participants. HCV virologic failure was defined as HCV RNA undetectable at end-of-treatment but HCV RNA quantifiable during follow-up with subsequent confirmation as quantifiable.|At time of HCV virologic failure; any time from start of study treatment to 24 weeks after end of study treatment. Duration of study treatment for Cohort 1 and 2 were 12 and 8 weeks, respectively.|Participants who observed an HCV virologic failure after successfully enrolling for first dose of treatment.|||Percentage of participants|||Number
2603865|NCT02128217|Secondary|Number of Participants Who Had HCV Virologic Relapse|HCV virologic relapse was defined as HCV RNA undetectable at end-of-treatment but HCV RNA quantifiable during follow-up with subsequent confirmation as quantifiable.|From end of study treatment through to 24 weeks after end of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.|Participants who successfully enrolled and started first dose of treatment.|||Participants|||Count of Participants
2603890|NCT02127710|Secondary|Apparent Total Clearance of AZD6094 From Plasma After Single Dose|The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.|24 Hours||||L/hour||Standard Deviation|Mean
2603891|NCT02127710|Secondary|Area Under Plasma Concentration Time Curve for AZD6094 After Single Dose (Time Zero to Last Measurement)|The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.|24 Hours||||h*ng/mL||Standard Deviation|Mean
2603866|NCT02128217|Secondary|Percentage of Participants With HCV RNA Undetectable After End of Study Treatment|"HCV RNA undetectable is defined as an HCV RNA measurement <LLOQ, TND. If there was no measurement at a scheduled time, then the participant was considered as having detectable HCV RNA at that time, unless both the preceding and succeeding measurements were undetectable. This outcome measure was referred to as SVR2, SVR4, SVR8 and SVR24 where SVR means sustained virologic response.~A two-sided 90% confidence interval was calculated for the percentage using the Blyth-Still-Casella method."|2, 4, 8 and 24 weeks after last dose of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.|"Participants who successfully enrolled and started first dose of treatment.~Note that one participant in Cohort 2 was lost to follow-up prior to week 24 and is imputed as not having SVR24 at week 24. This participant, however, had HCV RNA < LLOQ, TND at all moments from week 4 of study treatment."|||Percentage of participants||90% Confidence Interval|Number
2603867|NCT02128217|Secondary|Percentage of Participants With HCV RNA Undetectable During Study Treatment|"HCV RNA undetectable was defined as an HCV RNA measurement <LLOQ, TND. If there was no measurement at a scheduled time, then the participant was considered as having detectable HCV RNA at that time, unless both the preceding and succeeding measurements were undetectable.~A two-sided 90% confidence interval was calculated for each proportion using the Blyth-Still-Casella method."|1, 2, 4, 8 and, for the 12-week regimen, 12 weeks after starting study treatment.|Participants who successfully enrolled and started first dose of treatment.|||Percentage of participants||90% Confidence Interval|Number
2603868|NCT02128217|Primary|Percentage of Participants With an Occurrence of a Grade ≥ 2 Adverse Event, Serious AE According to ICH Criteria, or Treatment-limiting AE.|"Any adverse event occurring after initiation of study treatment through to 28 days after the date of last dose of study treatment was included (except that an event that was ongoing at the same grade from before start of study treatment was excluded). Adverse events consisted of Grade ≥ 2 primary diagnosis, primary sign/symptoms, and primary laboratory abnormality. It also included any serious adverse event according to ICH criteria and any treatment-limiting AE (ie, an AE reported as the reason for permanent discontinuation of study treatment).~A two-sided 90% confidence interval was calculated for the percentage using the Blyth-Still-Casella method."|From initiation of study treatment to 28 days after last dose of study treatment. The duration for study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.|Participants who enrolled and started first dose of study treatment.|||Percentage of participants||90% Confidence Interval|Number
2603869|NCT02128217|Primary|Percentage of Participants With Sustained Virologic Response 12 (SVR12)|"SVR12 was defined as HCV RNA undetectable less than the lower limit of quantification, Target Not Detected (<LLOQ TND) of the assay at 12 weeks after date of last dose of study treatment.~For both Cohort 1 and Cohort 2, the 12 week measurement used for determining SVR12 was the measurement obtained closest to 84 days (i.e. 12*7 days), within the window 79 to 112 days inclusive. If a participant did not have an HCV RNA measurement within this window, then the participant was considered as having detectable HCV RNA at 12 weeks unless the preceding and subsequent HCV RNA measurements were both undetectable (<LLOQ TND).~A two-sided 90% confidence interval was calculated for this percentage using the Blyth-Still-Casella method."|At 12 weeks after date of last dose of study treatment. The duration of study treatment for Cohort 1 and Cohort 2 were 12 and 8 weeks, respectively.|Participants who enrolled and started at least one dose of study treatment|||Percentage of participants||90% Confidence Interval|Number
2603870|NCT02128074|Primary|Change in Hemoglobin From Baseline to the End of 8-week Treatment Period||8 weeks||||g/dL||Standard Deviation|Mean
2603871|NCT02127970|Other Pre-specified|Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response|"The SSTI-C Questionnaire is an 11-item self-reported questionnaire that measures subjective experiences of the participant. One of the items assessed was overall satisfaction with treatment. Participants answered the question: Overall, how satisfied were you with your antibiotic treatment? using one of the following responses: Extremely satisfied, Moderately satisfied, Not at all satisfied, Slightly satisfied and Very satisfied. The percentage of participants in each category is reported."|EOT (Day 14-15)|ITT Population included all randomized participants regardless of whether or not they received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of participants|||Number
2603872|NCT02127970|Other Pre-specified|Percentage of Participants by Resource Utilization Categories|Resource Utilization Categories included: Any additional visits (including urgent care), Any additional procedures, Any additional tests, Any home visits or nursing care and Any ER Visits. The percentage of participants in each category is reported.|Final Visit (Day 28 +/- 2 days)|ITT Population included all randomized participants regardless of whether or not they received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of participants|||Number
2603873|NCT02127970|Other Pre-specified|Change From Baseline in Participant's Assessment of Pain|"Using the Brief Pain Inventory Scale, participants rated their pain right now on a scale where: 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement."|Baseline (Day 0) to Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 + /- 2 days)|ITT Population included all randomized participants regardless of whether or not they received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||Scores on a scale||Standard Deviation|Mean
2603874|NCT02127970|Other Pre-specified|Percentage of Participants With Complete Resolution of Local Signs of Infection|Resolution of Local Signs of Infection that include absence of purulence/drainage, erythema, heat/localized warmth, pain/tenderness to palpation, fluctuance, and swelling/induration.|Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 +/- 2 days)|ITT Population included all randomized participants regardless of whether or not they received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of participants|||Number
2603875|NCT02127970|Other Pre-specified|Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline|A successful outcome was based on resolution or improvement of all signs and symptoms of the infection to such an extent that no further antibacterial treatment was given.|Day 3-4 and EOT (Day 14-15)|Microbiological Intent-to-treat (MicroITT) Population included all ITT participants who had at least 1 Gram-positive bacterial pathogen isolated at Baseline. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of participants|||Number
2603876|NCT02127970|Other Pre-specified|Percentage of Participants by Investigator Assessment of Clinical Outcome|A successful outcome was based on resolution or improvement of all signs and symptoms of the infection to such an extent that no further antibacterial treatment was given. An unsuccessful outcome was the opposite of successful. An Indeterminate outcome was defined as any of the data needed to determine a successful or unsuccessful outcome were missing.|Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 +/- 2 days)|ITT Population included all randomized participants regardless of whether or not they received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.|||percentage of participants|||Number
2603877|NCT02127970|Other Pre-specified|Percentage of Participants by Clinical Status Based on Localized Fluctuance and Heat/Warmth at End of Treatment (EOT)|Clinical Success was defined as localized fluctuance and heat/warmth that if present at Baseline must be improved and no worse than mild. Clinical Failure was defined as the opposite to success. Clinical status was Indeterminate if any of the data needed to determine clinical success or clinical failure were missing.|EOT (Day 14-15)|ITT Population included all randomized participants regardless of whether or not they received study drug.|||percentage of participants|||Number
2603878|NCT02127970|Secondary|Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV)|Clinical Success is defined as follows: For evaluation at EOT visit, lesion area must be decreased by ≥80% from baseline and at FV lesion area must be decreased by ≥90% from baseline; Temperature is ≤37.6°C; Local signs of tenderness to palpation and swelling/induration are no worse than mild; For evaluation at EOT visit, local signs of fluctuance and localized heat/warmth must be improved from baseline and no worse than mild, and at FV local signs of fluctuance and localized heat/warmth must be absent; for participants with a wound infection the severity of purulent drainage is improved and no worse than mild relative to baseline. Clinical Failure is defined as the opposite to success or if the participant died during the study period up to visit or received study therapy for ABSSSI beyond the protocol treatment period. Clinical status is Indeterminate if any of the data needed to determine clinical success or clinical failure were missing.|End of Treatment (Day 14-15 after the initiation of study drug) and Final Visit (28 ±2 days after the initiation of study drug)|ITT Population included all randomized participants regardless of whether or not they received study drug.|||percentage of participants|||Number
2603879|NCT02127970|Primary|Percentage of Participants Who Were Clinical Responders 48-72 Hours After the Initiation of Study Drug|Clinical responder was defined as a participant who was alive and had received no rescue therapy for acute bacterial skin and skin structure infection (ABSSSI) prior to the 48-72 hour infection site assessment (if an antibiotic has been given for another reason, the participant will not be considered a non-responder for this reason); and examination of the participant's ABSSSI lesion demonstrates a decrease of ≥ 20% in lesion area (calculated as the longest length multiplied by the longest perpendicular width) relative to the baseline measurement.|Up to 48-72 hours after the initiation of study drug|ITT Population included all randomized participants regardless of whether or not they received study drug.|||percentage of participants|||Number
2603880|NCT02127931|Primary|Correlation of Groundskeeper Incorrect With CPT Commission Errors|"Groundskeeper is a game, there are four cubes and a base device, three of the cubes display a background of a grassy field, with occasional stimuli that pop up. The fourth cube displays a mallet. When a gopher is displayed on one of the cubes, the user must hit the gopher with the mallet. Groundskeeper incorrect counts of the number of incorrect responses when a target stimulus is presented. Continuous performance task (CPT), participants are asked to press the spacebar each time a letter appears in the middle of the screen, except when the letter is X. If the letter is an X, the participant should do nothing. Commission errors were when participant pressed the spacebar when an X appeared. Company no longer exists, and no longer has access to data collected. Only information from draft publication available."|45 minutes||||Correlation|||Number
2603881|NCT02127931|Primary|Correlation of CPT Commission Errors With ADHD-I and ADHD-C|"Continuous performance task (CPT), participants are asked to press the space bar when they are presented with any letter except the letter X. The participant must refrain from clicking if they see the letter X presented."|14 minutes||||Correlation|||Number
2603882|NCT02127931|Primary|Number of Participants That Tested High (6 or More Symptoms) for ADHD by Type Determined by Adult ADHD DSM IV-TR Checklist|Adult ADHD DSM IV-TR Checklist for determining ADHD subtypes: inattentive ADHD (ADHD-I), Hyperactive/impulsive ADHD (ADHD-H/I) and Combined ADHD (ADHD-C). Company no longer exitsts, and no longer has access to data collected. Only information from draft publication available|10 minutes||||Participants|||Count of Participants
2603883|NCT02127892|Other Pre-specified|Overall Survival|Overalls survival of patient at 1 year post transplant|1 year||||Participants|||Count of Participants
2603884|NCT02127892|Other Pre-specified|Number of Participants With Graft Versus Host Disease (GVHD) - Grade III or IV|GVHD disease surveillance done by clinical evaluation, to include history, physical examination, specifically for rash, jaundice, liver dysfunction, nausea and vomiting, diarrhea and failure to thrive.|1 year||||Participants|||Count of Participants
2603885|NCT02127892|Other Pre-specified|Number of Participants With Veno-occlusive Disease (VOD) - Moderate and Severe|Evaluation of veno-occlusive disease determined by the presence of the following features; fluid retention, weight gain, leaky capillary syndrome, painful liver enlargement, refractoriness to platelet tranfusion and hyperbilirubinemia|100 days||||Participants|||Count of Participants
2603886|NCT02127892|Secondary|Number of Participants With Donor-derived CD3+ T Lymphocytes >/= 100/mm3|Absolute number of donor-derived CD3+ T lymphocytes >/= 100/mm3 in participating subjects.|1 year||||Participants|||Count of Participants
2603887|NCT02127892|Primary|Number of Participants With Engraftment|Engraftment is defined as recovery of blood counts (neutrophil and platelet engraftment) with cells of donor origin, documented by either bone marrow or peripheral blood chimerism assays after hematopoietic stem cell transplant.|100 day||||Participants|||Count of Participants
2603888|NCT02127710|Secondary|Elimination Half-Life of AZD6094 After Single Dose|The number of patients analysed represent the number of patients with evaluable PK parameters for this endpoint.|24 Hours||||Hours||Standard Deviation|Mean
2603889|NCT02127710|Secondary|Mean Residence Time of AZD6094 After Single Dose|The number of patients analysed represent the number of evaluable PK parameters for this endpoint.|24 Hours||||Hours||Standard Deviation|Mean
2603896|NCT02127710|Secondary|Duration of Response|Duration of Response is the time from the first documentation of confirmed complete response/partial response until the date of progression, or death in the absence of progression. There were 8 responders: one of whom subsequently progressed or died and seven of whom were still classified as responders at the time of data cut-off and were therefore censored. It was not possible to determine a median or 75th percentile.|Up to 12 months||||Weeks||Inter-Quartile Range|Median
2603897|NCT02127710|Secondary|Change From Baseline in Target Lesion Tumour Size at 12 Weeks in Safety Analysis Set.|12 week summary for patients in the Safety analysis set by MET Status. The number of patients analysed represent the number of evaluable patients at the 12 week timepoint.|12 Weeks (at 12 week timepoint)||||Percent change||Standard Deviation|Mean
2603898|NCT02127710|Secondary|Change From Baseline in Target Lesion Tumour Size at 12 Weeks in Efficacy Analysis Set|12 week summary for patients in the Efficacy analysis set, by MET status. The numbers of patients analysed represent the numbers evaluable at the 12 week timepoint.|12 Weeks (at 12 weeks timepoint)||||Percent change||Standard Deviation|Mean
2603899|NCT02127710|Secondary|Overall Survival Stratified by c-MET Status in the Safety Analysis Set||Up to 12 months||||Weeks||95% Confidence Interval|Median
2603900|NCT02127710|Secondary|Progression Free Survival Stratified by c-MET Status in the Safety Analysis Set||Up to 12 months||||Weeks||95% Confidence Interval|Median
2603901|NCT02127710|Secondary|Overall Survival Stratified by c-MET Status in the Efficacy Analysis Set||Up to 12 months||||Weeks||95% Confidence Interval|Median
2603902|NCT02127710|Secondary|Progression Free Survival Stratified by c-MET Status in the Efficacy Analysis Set||Up to 12 months||||Weeks||95% Confidence Interval|Median
2603903|NCT02127710|Primary|Objective Response Rate (RECIST Version 1.1) Stratified by c-MET Status in Safety Analysis Set|The primary outcome measure was ORR, defined as the proportion of patients with either a confirmed complete response/partial response by investigator assessment according to RECIST v1.1.|12 Months|ORR was assessed on the safety analysis set, consisting of all patients who received at least one dose of the study drug (n = 109).|||Participants|||Count of Participants
2603904|NCT02127710|Primary|Objective Response Rate (RECIST Version 1.1) Stratified by c-MET Status in Efficacy Analysis Set|The primary outcome measure was ORR, defined as the proportion of patients with either a complete response or a partial response by investigator assessment according to RECIST v1.1.|12 Months|ORR was assessed on the efficacy analysis set, consisting of all patients with measurable disease, PRCC confirmed by a central laboratory and received at least 1 dose of AZD6094 (n = 84).|||Participants|||Count of Participants
2603905|NCT02127710|Primary|Objective Response Rate (RECIST Version 1.1)|The primary outcome measure was Objective Response Rate (ORR), defined as the proportion of patients with either a complete response or a partial response by investigator assessment according to Response Evaluation Criteria for Solid Tumours (RECIST) v1.1.|Up to 12 months|ORR was assessed on the efficacy analysis set, consisting of all patients with measurable disease, PRCC confirmed by a central laboratory and have received at least 1 dose of AZD6094 (n = 84).|||Participants|||Count of Participants
2603906|NCT02127632|Secondary|Throat Pain According to Visual Analogue Scale|Patients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, 1 hr and 24 hr after the end of surgery according to Visual Analogue Scale. (range min. 0, max.10; >4 analgesia planned)|postoperative 1st and 24th hours||||point||Standard Deviation|Mean
2603907|NCT02127632|Secondary|Evaluation of Gastric Distention|To provide the adequate gastric distention of either the LM-Supreme or the tracheal tube, as assigned. Gastric distension was evaluated by a surgeon blind to the airway device used between 0-10 (0=empty stomach, 10=distension obstructing the surgical field)|Baseline||||units on a scale||Standard Deviation|Mean
2603908|NCT02127632|Primary|Mean Airway Pressures|"The measure is the mean airway pressure (cmH2O):~T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device"|At first and last 10 minutes of pneumoperitoneum||||cmH20||Full Range|Mean
2603909|NCT02127567|Secondary|Average Score for Completeness of Reporting of Essential Elements|Completeness of reporting scores calculated based on essential elements to report, on a scale from 0 to 10, 0 being the lowest and10 the highest|one time four hour writing session||||units on a scale|Participants|Standard Deviation|Mean
2603910|NCT02127567|Secondary|The Score for Completeness of Reporting for Trial Design|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session||||units on a scale|Participants|Standard Deviation|Mean
2603911|NCT02127567|Secondary|The Score for Completeness of Reporting for Outcomes|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session||||units on a scale|Participants|Standard Deviation|Mean
2603912|NCT02127567|Secondary|The Score for Completeness of Reporting for Interventions|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session||||units on a scale|Participants|Standard Deviation|Mean
2603913|NCT02127567|Secondary|The Score for Completeness of Reporting for Participants|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session||||units on a scale|Participants|Standard Deviation|Mean
2603914|NCT02127567|Secondary|The Score for Completeness of Reporting for Blinding|on a scale from 0 to 10, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session||||units on a scale|Participants|Standard Deviation|Mean
2603915|NCT02127567|Secondary|The Score for Completeness of Reporting for Randomization|The score for completeness of reporting (0-10) for the manuscript section randomization, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session||||units on a scale|Participants|Standard Deviation|Mean
2603916|NCT02127567|Primary|The Primary Outcome Will be the Average Score for Completeness of Reporting on a Scale of 0-10.|Completeness of reporting will be determined according to a grading rubric individualized to each study protocol, 0 being the lowest and 10 the highest|one time measure after a four-hour writing session||||units on a scale|Participants|Standard Deviation|Mean
2604473|NCT02120300|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2603917|NCT02127372|Primary|Phase II - Radiographic Response|"The percentage of patients with a complete or partial response.~Responses for the Phase II portion of the trial will be by Response Evaluation Criteria In Solid Tumors (RECIST) criteria as follows:~Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD."|After Cycle 6, approximately 18 weeks.||||percentage of participants||95% Confidence Interval|Number
2603918|NCT02127372|Secondary|Change in Gd-MRI Measurement|The change in Gd-MRI perfusion/permeability measurement between pre and post 7-day of STI571 treatment.|Day 7|Because the study was terminated prior to completion, correlative studies were not run.||||||
2603919|NCT02127372|Secondary|Phase 2: 1 Year Survival|Phase II: Percentage of patients alive 1 year from the start of protocol treatment.|1 year||||percentage of participants||95% Confidence Interval|Number
2603920|NCT02127372|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of Docetaxel and Cisplatin|To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.|After cycle 1, day 22|One patient only received the lead-in dose of STI571 prior to withdrawing from the study without a DLT. This subject is not included in the DLT determination.|||mg/m2|||Number
2603921|NCT02127372|Primary|Phase 1 - Maximum Tolerated Dose (MTD) of STI571|To determine the maximum tolerated dose (MTD) of STI571, docetaxel, and cisplatin, when administered in combination for the treatment of patients with chemo-naïve recurrent and metastatic (stage IV) NSCLC.|After cycle 1, day 22|One patient only received the lead-in dose of STI571 prior to withdrawing from the study without a DLT. This subject is not included in the DLT determination.|||mg|||Number
2603922|NCT02127307|Primary|Relationship Between the Occurrence of Death and 123I-mIBG Uptake on Planar Scintigraphy With Heart to Mediastinum (H/M) Ratio of <1.60 vs H/M ≥1.60|H/M ratio for 123I-mIBG uptake at 3 hours 50 minutes post administration was calculated by dividing the counts/pixel in the total myocardium region of interest (ROI) by the counts/pixel in the 7x7 pixel mediastinal ROI. H/M ratios were categorized as 'Low' and 'High' based on being <1.6 or ≥1.6 respectively. The efficacy of 123I-mIBG was based on the prognostic value of the imaging data, as reflected by the H/M ratio, for identifying HF participants at lower risk of death during 60 months of follow-up.|From the date of administration of 123I-mIBG in studies MBG-311 or MBG-312 up to 60 months|Efficacy population was 961 participants who received investigational medicinal product (IMP) and had a diagnostic 3 hour 50 minute planar image in MBG311 or MBG312. Here, 'n' signifies number of participants with available data for specified category.|||number of death or other adverse events|||Number
2603923|NCT02127281|Secondary|Knee Extension|Median knee extension (degrees) at 4 weeks postoperatively|4 weeks postoperative||||degrees||Inter-Quartile Range|Median
2603924|NCT02127281|Secondary|Hip Range of Motion|Median hip range of motion (extension, in degrees) at 4 weeks postoperatively|4 weeks postoperative||||degrees||Inter-Quartile Range|Median
2603925|NCT02127281|Secondary|VR-12 Questionnaire|Mean VR-12 scores, presented as 2 composite scores physical component summary (PCS) and mental component summary (MCS). Physical Component Score (PCS): Provides greater emphasis on questions about general health, physical functioning and role playing and bodily pain. Mental Component Score (MCS): Provides greater emphasis on questions about role-emotional, vitality/mental health and social functioning. PCS and MCS summary scores are standardized using a z-score transformation and normed to a U.S. population (based on a 1990 norm) of a score of 50 and a standard deviation of 10. Higher MCS and PCS scores reflect better overall physical and mental health, respectively.|90 days postoperatively||||z-score||Standard Deviation|Mean
2603926|NCT02127281|Secondary|Hip Range of Motion (Flexion)|Mean hip range of motion (flexion, in degrees) at 4 weeks postoperatively|4 weeks postoperative||||degrees||Standard Deviation|Mean
2603927|NCT02127281|Secondary|Timed-up-and-go Test|Median Timed-up-and-go test (seconds)|4 weeks postoperatively||||seconds||Inter-Quartile Range|Median
2603928|NCT02127281|Secondary|HOOS and KOOS Scores at 90 Days Postoperatively|Mean Hip Osteoarthritis Outcome Score (HOOS), Knee Osteoarthritis Outcomes Score (KOOS) at 90 days postoperatively. Presented as subscores, including activities of daily living (ADL), pain, quality of life (QOL), symptoms, sports and recreation. All subscores range from 0-100, with 0 being the worst score and 100 being the best possible score.|90 days postoperative|The number analyzed is different from the overall number because there are separate questionnaires for Hip and Knee, and there were Hips and Knees in both the Prevena and Control groups|||units on a scale||Inter-Quartile Range|Median
2603929|NCT02127281|Secondary|HOOS and KOOS Scores at 90 Days Postoperatively|Mean Hip Osteoarthritis Outcome Score (HOOS), Knee Osteoarthritis Outcomes Score (KOOS) at 90 days postoperatively. Presented as subscores, including activities of daily living (ADL), pain, quality of life (QOL), symptoms, sports and recreation. All subscores range from 0-100, with 0 being the worst score and 100 being the best possible score.|90 days postoperative|The number analyzed is different from the overall number because there are separate questionnaires for Hip and Knee, and there were Hips and Knees in both the Prevena and Control groups|||units on a scale||Standard Deviation|Mean
2603930|NCT02127281|Secondary|Knee Flexion|Mean knee flexion (degrees) at 4 weeks postoperatively|4 weeks postoperative||||degrees||Standard Deviation|Mean
2603931|NCT02127281|Primary|Readmission Rates|Number of patients who had hospital readmission(s) related to the revision surgery that occurred within 90 days of revision|Within 90 days after surgery|"80 patients allocated to the prevena arm, and 79 patients were analyzed: 1 patient lost to follow-up; also, 1 patient had the prevena removed early but included as an intent to treat.~80 patients allocated to control arm, with 80 patients analyzed. 6 patients did not receive the allocated treatment but were included for intent to treat"|||Participants|||Count of Participants
2603932|NCT02127281|Primary|Re-operation Rates|Number of patients who required re-operations that were related to the revision arthroplasty and occurred within 90 days of the revision|Within 90 days after surgery|"80 patients allocated to the prevena arm, and 79 patients were analyzed: 1 patient lost to follow-up; also, 1 patient had the prevena removed early but included as an intent to treat.~80 patients allocated to control arm, with 80 patients analyzed. 6 patients did not receive the allocated treatment but were included for intent to treat"|||Participants|||Count of Participants
2604474|NCT02120300|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set|||percentage of participants|||Number
2603933|NCT02127281|Primary|Number of Patients With Wound Complications|Any wound complications including but not limited to drainage, blisters, cellulitis, superficial infection, and deep infection.|Within 90 days after surgery|"80 patients allocated to the prevena arm, and 79 patients were analyzed: 1 patient lost to follow-up; also, 1 patient had the prevena removed early but included as an intent to treat.~80 patients allocated to control arm, with 80 patients analyzed. 6 patients did not receive the allocated treatment but were included for intent to treat"|||participants|||Number
2603934|NCT02126969|Secondary|3-year Overall Survival|. I|Anticipated completion date July 2022||2021-03-31|03/2021||||
2603935|NCT02126969|Secondary|Quality of Life (QOL) of Patients Receiving Low Dose Fractionated Radiation Therapy With Chemotherapy.||Up to 50 days||2020-01-31|01/2020||||
2603936|NCT02126969|Secondary|Overall Response Rate|To assess overall response rate of patients to 2 cycles of induction Docetaxel and Carboplatin with or without LDFRT. Response assessment was Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, and Progressive Disease (PD): > 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). (Note: the appearance of one or more new lesions is also considered progression).|Up to 50 days||||Participants|||Count of Participants
2603937|NCT02126969|Primary|Primary Site Complete Response Rate|Primary site is defined as the original, or first site that the cancer developed in the body. In this study, primary sites within the head and neck included squamous cancers of the larynx, oral cavity, oropharynx, hypopharynx.Complete response rate in patients treated with 2 cycles of induction Docetaxel and Carboplatin with low dose fractionated radiation therapy (LDFRT) will be compared to those treated with chemotherapy alone. CRR was determined Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Where possible, surgeon also evaluated primary site and provided response assessment.|Up to 50 days||||Participants|||Count of Participants
2603938|NCT02126839|Secondary|Summary of Participants With Adverse Events|"Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator as mild (no limitation of usual activities), moderate, or severe (inability to carry out usual activities).~Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes."|6 Months|Safety Analysis set includes all participants who receive at least 1 dose of study drug. In this population, treatment is assigned based upon the treatment participants actually receive, regardless of the treatment to which they were randomized.|||participants|||Number
2603939|NCT02126839|Secondary|Baseline Adjusted Peak Expiratory Flow (PEF) Area Under The Concentration Time Curve Up From Time Zero up to 6 Hours (AUC0-6) Over 3 Weeks|Serial PEF measurements were obtained via spirometry. PEF measures for purpose of serial PEF assessment (pre and postdose) were collected from the spirometer assessed PEF, utilizing the values from the efforts selected based on the highest of 3 acceptable FEV1 maneuvers.|30 ±5 and 5 ±2 minutes prior to dosing, and at 5 ±2, 15 ±5, 30 ±5, 45 ±5, 60 ±10, 120 ±10, 240 ±10, and 360 ±10 minutes after completion of dosing on Days 1 and 22|Full analysis set|||Liters/min*hour||Standard Error|Least Squares Mean
2603940|NCT02126839|Primary|Baseline Adjusted Percent Predicted Forced Expiratory Volume In 1 Second (FEV1) Area Under The Concentration Time Curve Up From Time Zero up to 6 Hours (AUC0-6) Over 3 Weeks|Following measurement of the baseline FEV1 and dose administration on Days 1 and 22, FEV1 values (highest of 3 acceptable maneuvers) will be obtained at 5 (±2), 15 (±5), 30 (±5), 45 (±5), 60 (±10), 120 (±10), 240 (±10), and 360 (±10) minutes after the completion of dosing. Predicted FEV1 values were computed and adjusted for age, height, and gender according to Eigen et al (Eigen et al 2001) for participants 4 to 5 years of age and to Quanjer et al (Quanjer et al 1995) for participants aged 6 to 11 years using ATS criteria (American Thoracic Society/European Respiratory Society Statement 2007).|30 ±5 and 5 ±2 minutes prior to dosing, and at 5 ±2, 15 ±5, 30 ±5, 45 ±5, 60 ±10, 120 ±10, 240 ±10, and 360 ±10 minutes after completion of dosing on Days 1 and 22|The full analysis set (FAS) includes all participants in the ITT population who receive at least 1 dose of study medication and have at least 1 postbaseline assessment of the primary endpoint.|||% predicted FEV1/hour||Standard Error|Least Squares Mean
2603941|NCT02126826|Secondary|Area Under the Concentration-time Curve at Steady-state (AUCτ,ss)|Area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval τ (AUCτ,ss).|5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12|PKS|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2603942|NCT02126826|Secondary|Time From Last Dosing to Maximum Measured Concentration at Steady-state (Tmax,ss)|Time from last dosing to maximum concentration of the analyte in plasma at steady-state (Tmax,ss).|5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12|PKS|||hours||Full Range|Median
2603943|NCT02126826|Secondary|Maximum Measured Concentration at Steady-state (Cmax,ss)|Maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval τ (Cmax,ss).|5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12|PKS|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2604122|NCT02123745|Secondary|Yellow Notification Sensitivity to Infiltrated Tissues|The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a yellow notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.|After each participant has been infiltrated, an expected average of 1 hour||||percentage of infiltrations|Participants|95% Confidence Interval|Number
2603944|NCT02126826|Secondary|Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 12h (AUC0-12)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 12 hours (h) (AUC0-12).|1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h and 12h after first drug admin|PKS|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2603945|NCT02126826|Secondary|Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 24h (AUC0-24)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24 hours (h) (AUC0-24).|1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin|PKS|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2603946|NCT02126826|Secondary|Time From Dosing to Maximum Measured Concentration (Tmax)|Time from dosing to maximum measured concentration of the analyte in plasma (Tmax)|1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin.|PKS|||hours||Full Range|Median
2603947|NCT02126826|Secondary|Maximum Measured Concentration (Cmax)|Maximum measured concentration of the analyte in plasma (Cmax)|1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin|Pharmacokinetic set (PKS) which included all patients and healthy subjects in the TS who provided at least 1 PK endpoint value without relevant protocol deviations with respect to the evaluation of PK endpoints.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2603948|NCT02126826|Primary|Percentage of Subjects With Drug Related Adverse Events|Percentage of subjects with drug related adverse events (AEs)|From first drug administration until 3 days after last drug administration, 15 days|Treated set (TS)|||Percentage of participants|||Number
2603949|NCT02126748|Secondary|Oxygen Saturation (SaO2)|oxygen saturation (SaO2) measured by pulse -oximetry|before, after and 1h after treatment|||||||
2603950|NCT02126748|Secondary|Heartrate||before, after and 1h after intervention|||||||
2603951|NCT02126748|Secondary|Wang Score||before treatment, immediately after treatment and 1h after treatment|||||||
2603952|NCT02126748|Primary|Length of Hospital Stay|Previously publised data ( Luo et al. 2011) showed that the average hospital stay for infants with acute viral bronchiolitis, inhaling 4 ml NaCl3%, three times /day is 6 days ( SD 1,2)|6 days||||days||Standard Deviation|Mean
2603953|NCT02126670|Secondary|Irritation Score|Percentage of participants with moderate or severe overall irritation at end of treatment.|up to Day 57|Overall irritation|||percentage of participants|||Number
2603954|NCT02126670|Primary|Treatment Success at End of Study Visit|Treatment success at end of study visit defined as % of participants with 100% clearance of AK lesions|up to Day 57|Per protocol|||percentage of participants||95% Confidence Interval|Number
2603955|NCT02126319|Primary|Pca Related Intrusive Ideation|Intrusive ideation related to prostate cancer risk was assessed using the Impact of Events Scale (IES) (Horowitz et al., 1979). The full scale consists of two subscales, intrusive ideation and avoidant ideation but only the intrusive ideation subscale was used in the present study. The instrument has been used extensively in the cancer literature (Schwartz et al., 2002). Cronbach's alpha for the intrusion subscale in the present study was 0.82. Values range from zero to 35, with higher values indicating higher level of intrusive ideation. Because of high skewness, a median split was used to create a high intrusive ideation group and a low intrusive ideation group.|Six months||||units on a scale||Standard Deviation|Mean
2603956|NCT02126319|Primary|Negative Expectations Regarding Pca Risk|"Negative expectations related to Pca risk screening comprised five items and assessed the costs and risks of screening, in terms of time and effort, fears of discrimination, insurance and employment, and financial concerns on a five-point scale (e.g., Screening may have a negative impact on my health insurance). Questionnaire items were author-constructed, based on our prior work and cognitive-affective theory (Miller et al., 1996). Reported means are based on a scale from one to five (average of five items). Cronbach's alpha for the scale was 0.80. A higher score indicates more negative expectations."|Six months||||units on a scale||Standard Deviation|Mean
2603957|NCT02126319|Primary|Pca-related Positive Expectations|"Positive expectations regarding the effects of screening were assessed using two items on a five-point scale (Regular screening will ensure that I stay healthy and Regular screening will prolong my life). Questionnaire items were author-constructed, based on our prior work and cognitive-affective theory (Miller et al., 1996). Reported means are based on a scale from one to five (average of the two items). Cronbach's alpha for the scale was 0.76. Higher score indicates more positive expectations."|six months||||units on a scale||Standard Deviation|Mean
2603958|NCT02126319|Primary|Pca Perceived Risk|"Perceived risk of Pca was assessed using four items where participants were asked to estimate their prostate cancer risk in general (e.g., Do you feel as though you are the kind of person who is likely to develop prostate cancer?) or comparing themselves to other men at risk for Pca (e.g., Given your ethnicity, what are your chance of getting prostate cancer?) on a five-point scale (Lerman et al., 1996). Reported means are based on a scale from one to five (based on the average of the four items). Cronbach's alpha for the scale was 0.83. A higher score indicates higher Pca perceived risk."|six months||||units on a scale||Standard Deviation|Mean
2603959|NCT02126319|Primary|Pca Risk-related Knowledge|"Knowledge about Pca risk was measured using an eight item scale prepared for this study. It consisted of true/false items [e.g., An abnormal digital rectal examination (DRE) and/or prostate-specific antigen (PSA) could be the result of conditions other than prostate cancer]. Correct responses received a value of one, whereas false responses received a zero. Values ranged between zero and eight. Higher score means better knowledge of risk and issues."|six months||||units on a scale||Standard Deviation|Mean
2603986|NCT02125734|Secondary|Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions.|The investigator preference for future treatment suggestion after experiencing both treatments was assessed at the end of treatment period 2 with the Investigator Preference Questionnaire|8 weeks|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. One patient with missing data for this analysis.|||Participants|||Number
2603960|NCT02126319|Primary|Pca Related Intrusive Ideation|Intrusive ideation related to prostate cancer risk was assessed using the Impact of Events Scale (IES) (Horowitz et al., 1979). The full scale consists of two subscales, intrusive ideation and avoidant ideation. In this study only the intrusive ideation subscale was used. The instrument has been used extensively in the cancer literature (Schwartz et al., 2002). Values range from 0 to 35, with higher values indicating a higher level of intrusive ideation. Cronbach's alpha for the intrusion subscale in the present study was 0.82. Because of high skewness, a median split was used to create a high intrusive ideation group and a low intrusive ideation group.|three weeks||||units on a scale||Standard Deviation|Mean
2603961|NCT02126319|Primary|Negative Expectations Regarding Pca Risk|"Negative expectations related to Pca screening comprised five items and assessed the costs and risks of screening, in terms of time and effort, fears of discrimination, insurance and employment, and financial concerns on a five-point scale (e.g., Screening may have a negative impact on my health insurance). Questionnaire items were author-constructed, based on our prior work and cognitive-affective theory (Miller et al., 1996). Reported means are based on a scale from one to five (average of five items). Cronbach's alpha for the scale was 0.80. A higher score indicates more negative expectations."|three weeks||||units on a scale||Standard Deviation|Mean
2603962|NCT02126319|Primary|Pca-related Positive Expectations|"Positive expectations regarding the effects of screening were assessed using two items on a five-point scale (Regular screening will ensure that I stay healthy and Regular screening will prolong my life). Questionnaire items were author-constructed, based on our prior work and cognitive-affective theory (Miller et al., 1996). Reported means are based on a scale from one to five (average of the two items). Cronbach's alpha for the scale was 0.76. Higher score indicates more positive expectations."|three weeks||||units on a scale||Standard Deviation|Mean
2603963|NCT02126319|Primary|Pca Perceived Risk|"Perceived risk of Pca was assessed using four items where participants were asked to estimate their prostate cancer risk in general (e.g., Do you feel as though you are the kind of person who is likely to develop prostate cancer?) or comparing themselves to other men at risk for Pca (e.g., Given your ethnicity, what are your chance of getting prostate cancer?) on a five-point scale (Lerman et al., 1996). Reported means are based on a scale from one to five (based on the average of the four items). Cronbach's alpha for the scale was 0.83. A higher score indicates higher Pca perceived risk."|three weeks||||units on a scale||Standard Deviation|Mean
2603964|NCT02126319|Primary|Pca Risk-related Knowledge|"Knowledge about Pca risk was measured using an eight item scale prepared for this study. It consisted of true/false items [e.g., An abnormal digital rectal examination (DRE) and/or prostate-specific antigen (PSA) could be the result of conditions other than prostate cancer]. Correct responses received a value of one, whereas false responses received a zero. Values ranged between zero and eight. Higher score means better knowledge of risk and issues."|three weeks||||units on a scale||Standard Deviation|Mean
2603965|NCT02126306|Primary|Number of Participants With a Decrease of 2 Points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) Analysis is Per Protocol|"Number of Participants who had a decrease of 2 points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) from baseline at 40 weeks per protocol analysis. The score is performed on the liver biopsy before and after treatment. The total score is used with a range from 4-16. A decrease in the total score by 2 points or more is considered an improvement, while an increase in the total score by 2 points or more is considered deterioration. No use of subscales for the data analysis was made.~Allparticipants in both arms who showed a decrease of 2 points or more in the Non-Alcoholic Fatty Liver Disease Activity Score are conisdered as responders. Only values quantifying data that were actually measured and analyzed are included."|Total score from baseline compared with week 40.||||participants|||Number
2603966|NCT02125877|Secondary|Dererasirox Plasma Concentration|Blood samples were collected to assess deferasirox concentration. Dose-adjusted calculations are presented: (concentration/actual dose)*20 for participants on DFX-DT and (concentration/actual dose)*14 for participants on DFX-FCT.|Week 3, day 1, pre-dose (0 hour (h)) and 2 h post-dose; week 13, day 1, pre-dose (0 hour (h)) and 2 h post-dose; and week 21, day 1, pre-dose (0 hour (h)) and 2 h post-dose|The Pharmacokinetic analysis set for all participants was considered for this analysis, but only participants with non-missing values were included in the analysis.|||umol/L||Standard Deviation|Mean
2603967|NCT02125877|Secondary|Time to Reach the Maximum Plasma Concentration After Drug Administration (Tmax)|Blood samples were collected to assess Tmax.|week 1, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose; week 3, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose|The Pharmacokinetic subset A analysis set was considered for the analysis, but only participants with non-missing values were analyzed|||hour||Full Range|Median
2603968|NCT02125877|Secondary|Observed Maximum Plasma Concentration Following Drug Administration (Cmax)|Blood samples were collected to assess Cmax.|week 1, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose; week 3, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose|The Pharmacokinetic subset A analysis set was considered for the analysis, but only participants with non-missing values were analyzed|||umol/L||Standard Deviation|Mean
2603969|NCT02125877|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)|Blood samples were collected to assess AUClast.|week 1, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose; week 3, day 1: pre-dose (0 hour) and 1, 2, 3, 4, 8 and 24 hours post dose|The Pharmacokinetic subset A analysis set was considered for the analysis, but only participants with non-missing values were analyzed.|||umol/L*h||Standard Deviation|Mean
2603970|NCT02125877|Secondary|Weekly Dose Violation Rate|The dose violation is defined as a dose either missed completely or not taken in accordance with the timing instruction (no later than 12:00 pm. The rate was calculated as [number of dose violations/drug exposure (days)] x 100.|weeks 1, 4, 8, 12, 16, 20, 24|The safety set, which included all participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at the given week were included in the analysis for that week.|||percent dose violation||Standard Deviation|Mean
2603971|NCT02125877|Secondary|Number of Participants With Weekly Average Compliance of Medication Consumption|A compliance questionnaire assessed whether the medication was taken. Weekly average compliance was calculated when there were at least four non-missing daily responses.|Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24|The safety set, which included all participants who received at least one dose of study drug, was analyzed.|||Participants|||Number
2603972|NCT02125877|Secondary|Weekly Average of Daily Scores of the Gastrointestinal (GI) Symptom Diary|The GI symptom diary consisted of 6 items, five which were scored using a 0 - 10 rating scale with item appropriate anchors to rate the symptom, for example, Pain in your belly: 0 = no pain and 10 = worst pain. The GI diary summary score was created using the 10 point response scale for the 5 items. The GI symptom daily diary had a minimum score of 0 and a maximum score of 50. The weekly average score for the 7 days was calculated for each individual item and the GI summary score was created from these weekly averages. Higher scores indicated worse symptoms. A meaningful difference between two treatment arms was determined to be 0.3 point.|weeks -1, 4, 8, 12, 16, 20, 24|The safety set, which included all participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at the given week were included in the analysis for that week.|||score on a scale||Standard Deviation|Mean
2603973|NCT02125877|Secondary|Palatability Questionnaire Score|"The palatability questionnaire consisted of 4 items. The first item measured the taste and aftertaste of the medication and were scored a on a 5-point response scale. The second item offered an additional response option of no aftertaste. The last 2 items referred to whether the medication was taken, i.e. swallowed or vomited, and how the participant perceived the amount of medication to be taken. The palatability summary score was calculated using a scoring matrix from items 1, 3 and 4 scores and the score ranges from 0 - 11. Higher scores indicated the best palatability. A meaningful difference between two treatment arms was determined to be 1 point."|weeks 2, 3, 13 and 24 (end of treatment or within 7 days of last dose)|The safety set, which included all participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at the given week were included in the analysis for that week.|||score on a scale||Standard Deviation|Mean
2603974|NCT02125877|Secondary|Mean Domain Scores of the Modified Satisfaction With Iron Chelation Therapy (Modified SICT)|The modified SICT consisted of 13 items that represent 3 domains: adherence, satisfaction and concerns. The adherence domain consisted of 7 items, 6 which were measured using a 5-point response scale and was calculated by summing the 6 items. The score range from 6 to 30 and higher scores indicated worse adherence. The satisfaction domain consisted of 3 items, 2 which were measured using a 5-point response scale and was calculated by summing the 2 items. The score range from 2 to 10 and higher scores indicated worse satisfaction. The concerns domain consisted of 3 items to address any concerns or worries with his/her medication. All 3 items were measured on a 5-point response scale and were calculated by summing the 3 items. The score range from 3 to 15 and higher scores indicated fewer concerns. For all three domains, the meaningful difference between two treatment arms was determined to be 1 point.|weeks 2, 3, 13 and 24 (end of treatment or within 7 days of last dose)|The safety set, which included all participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at the given week were included in the analysis for that week.|||score on a scale||Standard Deviation|Mean
2603975|NCT02125877|Secondary|Frequency of Selected Gastro-intestinal (GI) Adverse Events|The percentage of participants with any GI adverse event, diarrhea, constipation, nausea, vomiting, abdominal pain was assessed.|28 weeks|The safety set, which included all participants who received at least one dose of study drug, was analyzed.|||Percentage of participants|||Number
2603976|NCT02125877|Primary|Overall Safety as Measured by Changes in Laboratory Values From Baseline|The percentage of participants with post-baseline laboratory values meeting specified criteria for notable/extended range was assessed. The following laboratory parameters were measured: platelet count, absolute neutrophils, serum creatinine , creatinine clearance, urinary protein/urinary creatinine ratio, alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Note that within data categories, creat = creatinine, cons = consecutive, ULN = upper limit of normal and urin = urinary.|baseline (BL), 30 weeks|The safety set, which included all participants who received at least one dose of study drug, was analyzed.|||Percentage of participants|||Number
2603977|NCT02125877|Primary|Overall Safety as Measured by Frequency of Adverse Events|The percentage of participants with adverse events, serious adverse events and deaths was assessed.|28 weeks|The safety set, which included all participants who received at least one dose of study drug, was analyzed.|||Percentage of participants|||Number
2603978|NCT02125838|Primary|Asses to Mean Pressure|mean pressures within the times below (cmH20) T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device|during procedure||||cmH20||Standard Deviation|Mean
2603979|NCT02125838|Primary|Asses to Peak Pressure|peak pressure (cmH20) at certain time intervals T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device|intraoperative period||||cmH20||Standard Deviation|Mean
2603980|NCT02125838|Secondary|Incidence of Post-operative Sore Throat|Patients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, independent of swallowing, 1 hr and 24 hr after the end of surgery.|Baseline|||||||
2603981|NCT02125838|Secondary|Haemodynamic Response to Insertion of Airway Device|Systolic blood pressure and heart rate at two minutes after LM-S placement, before insufflation, 10 minutes after insufflation and trendelenburg position, before desufflation and before LM-S removal .|Baseline|||||||
2603982|NCT02125838|Secondary|Ease of Orogastric Tube Placement Classification|Ease of placement was classified by the person who inserted the orogastric tube as very easy, easy, difficult or very difficult.|Baseline|Ease of placement was classified by the person who inserted the orogastric tube as very easy, easy, difficult or very difficult.|||participants|||Number
2603983|NCT02125838|Secondary|Evaluation of Gastric Distention|To provide the adequate gastric distention of either the LM-Supreme or the tracheal tube, as assigned. Gastric distension was evaluated by a surgeon blind to the airway device used between 0-10 (0=empty stomach, 10=distension obstructing the surgical field)|Baseline||||units on a scale||Standard Deviation|Mean
2603984|NCT02125838|Secondary|Quality of View According to Surgeon by Rate Scale|"Quality of surgical view will be assessed with points from 1 to 4 by the surgeon blind to the airway device by Rate Scale.~Grade of quality of view were evaluated between 1-4 points (1-poor to 4-excellent)"|intraoperative period||||percentage of participants|||Number
2603985|NCT02125838|Primary|Asses to Ventilation Parameters|tidal volume (ml) at certain time intervals T1= 2 minutes after airway device insertion T2= 10 minutes after insufflation T3= Before desufflation T4= Before removal of airway device|intraoperative period||||ml||Standard Deviation|Mean
2603987|NCT02125734|Secondary|Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire.|Patient preference after experiencing both treatments. The patient's preference questionnaire was a two-choice question (preference for QVA149 OR Tiotropium.|8 weeks|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Three patients were missing data for the patient preference analysis.|||Participants|||Number
2603988|NCT02125734|Primary|Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation|Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.|week 4|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period|||Liters||95% Confidence Interval|Least Squares Mean
2603989|NCT02125604|Primary|Duration of Gastrointestinal-Related Events in Participants Who Utilize Symptomatic Therapy During the 12-Week Treatment Period, MAGISS|Percentage of days with GI events as reported on MAGISS was calculated for each participant and each analysis period using the following formula: 100 x (# of days with [GI] events / # of days tolerability scale completed). The ST categories were provided by Biogen Medical team as follows: ST1=anti-acid production; ST2=anti-bloating/anti-constipation agent; ST3=multitarget/ herbal agents; ST4=anti-diarrheal (anti-peristaltic); ST5=analgesic (NSAID); ST6=anti-emetic (central); ST7=anti-emetic (pro-kinetic); ST8=antacid; ST9=other; ST10=laxative (pro-kinetic). Overall GI events were reported in the second day after the dose. Relative day for Overall GI events = assessment date-first dose date.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.|||percentage of days||Standard Deviation|Mean
2603990|NCT02125604|Secondary|Percentage of Participants Who Discontinued Dimethyl Fumarate Due To Gastrointestinal-Related Treatment-Emergent Adverse Events||Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate.|||percentage of participants|||Number
2603991|NCT02125604|Secondary|Percentage of Participants Who Required Dimethyl Fumarate Dose Reduction In Response To Gastrointestinal-Related Events|Dose reductions are defined as participants who take any dimethyl fumarate 120 mg or 0 mg since initiation of dimethyl fumarate 240 mg.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate.|||percentage of participants|||Number
2603992|NCT02125604|Secondary|Duration of Use of Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category|Symptomatic therapies were classified into 10 categories: anti-acid production (eg, pantoprazole, omeprazole, esomeprazole, ranitidine); anti-bloating/anti-constipation agents (eg, hyoscine butylbromide, sodium picosulfate, Agiolax, dimeticone, lactulose, Movicol, simethicone); multitarget/herbal agents (eg, Iberogast, Gaviscon, amaratropfen, Wikalin, Gaviscon & Iberogast, Iberogast & Wikalin); anti-diarrheal (anti-peristaltic; loperamide, racecadotril); analgesic (NSAID; ibuprofen, paracetamol, metamizole); anti-emetic (central; dimenhydrinate, domperidone); anti-emetic (pro-kinetic; metoclopramide); anti-acid (calcium carbonate, magaldrate, sodium hydrogen carbonate, sodium hydroxide/aluminium oxide, Talcid); other (Saccharomyces boulardii, carbon tablet, Lactobacillus acidophilus); laxative (pro-kinetic; bisacodyl). If a participant had multiple different therapies on the same day, the days on symptomatic therapy was calculated as 1 day in 'All therapies'.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.|||days||Standard Deviation|Mean
2603993|NCT02125604|Secondary|Number of Participants Who Used Symptomatic Therapies for Gastrointestinal-Related Events During the 12-Week Treatment Period, by Category|Symptomatic therapies were classified into 10 main categories: anti-acid production (eg, pantoprazole, omeprazole, esomeprazole, ranitidine); anti-bloating/anti-constipation agents (eg, hyoscine butylbromide, sodium picosulfate, Agiolax, dimeticone, lactulose, Movicol, simethicone); multitarget/herbal agents (includes Iberogast, Gaviscon, amaratropfen, Wikalin, Gaviscon & Iberogast, Iberogast & Wikalin); anti-diarrheal (anti-peristaltic; loperamide, racecadotril); analgesic (non-steroidal anti-inflammatory drug [NSAID]; ibuprofen, paracetamol, metamizole); anti-emetic (central; dimenhydrinate, domperidone); anti-emetic (pro-kinetic; metoclopramide); anti-acid (calcium carbonate, magaldrate, sodium hydrogen carbonate, sodium hydroxide/aluminium oxide, Talcid); other (Saccharomyces boulardii, carbon tablet, Lactobacillus acidophilus); laxative (pro-kinetic; bisacodyl). Participants may have taken > 1 symptomatic therapy but were counted only once for the 'All therapies' summary.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy.|||participants|||Number
2603994|NCT02125604|Secondary|Percentage of Participants Who First Took Symptomatic Therapy for Gastrointestinal-Related Events at Weeks 4, 8, and 12|The cumulative percentage of dimethyl fumarate-treated participants with relapsing-remitting multiple sclerosis who required symptomatic therapy up to Week 4, Week 8, and Week 12 were estimated using the Kaplan-Meier method.|Week 4, Week 8, Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy.|||percentage of participants|||Number
2603995|NCT02125604|Primary|Duration of Gastrointestinal-Related Events in Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS|The percentage of days with GI events as reported on MOGISS was calculated for each participant and each analysis period using the following formula: 100 x (# of days with [GI] events / # of days tolerability scale completed). The symptomatic therapy (ST) categories were provided by Biogen Medical team as follows: ST1=anti-acid production; ST2=anti-bloating/anti-constipation agent; ST3=multitarget/ herbal agents; ST4=anti-diarrheal (anti-peristaltic); ST5=analgesic (NSAID); ST6=anti-emetic (central); ST7=anti-emetic (pro-kinetic); ST8=antacid; ST9=other; ST10=laxative (pro-kinetic). Overall GI events were reported in the second day after the dose. Relative day for Overall GI events = assessment date-first dose date.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.|||percentage of days||Standard Deviation|Mean
2604013|NCT02125292|Secondary|Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Results|Subjects underwent a standard 12-lead ECG 6 hours post-dose. The investigator assessed if the ECG tracing was normal or abnormal; if abnormal, the investigator made a determination of whether or not the abnormality was clinically significant.|1 day|Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||participants|||Number
2603996|NCT02125604|Primary|Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MAGISS|The MAGISS is a questionnaire about the overall events related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) following drug administration (acute symptoms). MAGISS is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. The worst overall severity score for gastrointestinal-related events was calculated for each participant for the overall treatment period of 12 weeks, and for each 4-week period therein.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.|||units on a scale||Standard Deviation|Mean
2603997|NCT02125604|Primary|Worst Severity Of Gastrointestinal-Related Events In Participants Who Utilized Symptomatic Therapy During the 12-Week Treatment Period, MOGISS|The MOGISS is a questionnaire about overall events related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. MOGISS is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. The worst overall severity score for gastrointestinal-related events was calculated for each participant for the overall treatment period of 12 weeks, and for each 4-week period therein.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate and used symptomatic therapy; n=participants with an evaluable assessment during given time period.|||units on a scale||Standard Deviation|Mean
2603998|NCT02125604|Primary|Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Acute Gastrointestinal Symptom Scale (MAGISS)|The MAGISS is a questionnaire in which participants reported overall acute gastrointestinal-related events, (especially symptoms of nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) for each 10 hours after the AM and PM doses of study drug. Participants who rated the intensity of gastrointestinal-related events reported on MAGISS, included the duration of the gastrointestinal-related events and each symptomatic therapy used in the eDiary are presented.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate; n=participants with an assessment during given time period.|||Participants|||Number
2603999|NCT02125604|Primary|Number of Participants Who Utilized Symptomatic Therapy With Gastrointestinal-Related Events During the 12-Week Treatment Period: Modified Overall Gastrointestinal Symptom Scale (MOGISS)|The MOGISS is a questionnaire about the severity of overall gastrointestinal-related events, including specifically symptoms of nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence for 24 hours before the AM dose. Participants who rated the intensity of symptoms reported on the MOGISS and included each symptomatic therapy used in the eDiary are presented.|Up to Week 12|Safety Population: all participants who received at least 1 dose of dimethyl fumarate; n=participants with an assessment during given time period.|||Participants|||Number
2604000|NCT02125461|Secondary|Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab|ADA positive post-baseline only was also referred to as treatment-induced ADA positive. Treatment-boosted ADA was defined as baseline positive ADA titer that was boosted by ≥4-fold following drug administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. Confirmed ADA positive samples were subsequently tested in a neutralizing antibody assay.|Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48. Analysis performed at 22 Mar 2018 DCO.|ADA evaluable population included patients who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA results.|||Participants|||Count of Participants
2604001|NCT02125461|Secondary|Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations|To evaluate PK, blood samples were collected pre-dose and post-dose and trough and peak serum concentrations of durvalumab, respectively, were determined. Pre-dose samples were taken within 60 minutes before infusion and post-dose samples were taken within 10 minutes after the end of infusion.|Samples were collected pre-dose on Day 1 (Week 0), Week 8, Week 24 and Week 48, and post-dose on Day 1 (Week 0) and Week 24. Analysis performed at 22 Mar 2018 DCO.|PK analysis set included all patients who received at least 1 dose of durvalumab per the protocol, for whom any post-dose data were available, and who did not violate or deviate from the protocol in ways that would significantly affect the PK analyses.|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2604002|NCT02125461|Secondary|Time to Deterioration of Primary Patient-Reported Outcome (PRO) Symptoms, Assessed Using European Organization for Research and Treatment of Cancer QoL Lung Cancer Module (EORTC QLQ-LC13)|The EORTC QLQ-LC13 is a lung cancer specific module from the EORTC comprising 13 questions to assess lung cancer symptoms (cough, hemoptysis, dyspnea, chest pain, arm/shoulder pain, and other pain), treatment related side-effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores from 0 to 100 were derived for each symptom item with higher scores representing greater symptom severity. Time to symptom deterioration was defined as time from randomization until the date of first clinically meaningful symptom deterioration (an increase in the score from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful symptom deterioration. Results are presented for time to deterioration in the following PRO endpoints identified as primary for EORTC QLQ-LC13: dyspnea, cough, hemoptysis and chest pain. Time to deterioration was calculated using the Kaplan-Meier technique.|At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.|FAS included all randomized patients, analyzed on an ITT basis. Only patients with baseline scores ≤ 90 were included in the analysis.|||Months||95% Confidence Interval|Median
2604036|NCT02125279|Primary|Change From Screening in Urine Calcium/Creatinine Ratio at Week 30 (Follow-up)|Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 30 were reported.|Screening, Week 30 (Follow-up)|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Ratio||Standard Deviation|Mean
2604003|NCT02125461|Secondary|Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL), Assessed Using European Organization for Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30)|"Global health status/HRQoL was assessed using the EORTC QLQ-C30 global QoL scale which includes 2 items from the QLQ-C30: How would you rate your overall health during the past week? (Item 29) and How would you rate your overall QoL during the past week? (Item 30). Scores from 0 to 100 were derived for each item with higher scores indicating a better health status. Time to deterioration for global health status/HRQoL was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in global health status/HRQoL from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful deterioration. Time to deterioration was calculated using the Kaplan-Meier technique."|At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.|FAS included all randomized patients, analyzed on an ITT basis. Only patients with baseline scores ≥ 10 were included in the analysis.|||Months||95% Confidence Interval|Median
2604004|NCT02125461|Secondary|Time to Second Progression or Death (PFS2)|PFS2 was defined as the time from randomization to the time of the second progression or death. The date of second progression was recorded by the investigator and defined according to local standard clinical practice, and could have involved any of the following: objective radiological, symptomatic progression, or death. RECIST assessments were not collected for assessment of PFS2. PFS2 was calculated using the Kaplan-Meier technique.|Following confirmed progression, patients were assessed every ~12 weeks until second disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.|FAS included all randomized patients, analyzed on an ITT basis.|||Months||95% Confidence Interval|Median
2604005|NCT02125461|Secondary|Percentage of Patients Alive at 24 Months (OS24)|OS24 was defined as the percentage of patients who were alive at 24 months after randomization per the Kaplan-Meier estimate of OS at 24 months.|From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.|FAS included all randomized patients, analyzed on an ITT basis.|||Percentage of participants||95% Confidence Interval|Number
2604006|NCT02125461|Secondary|Time to Death or Distant Metastasis (TTDM) Based on BICR Assessments According to RECIST 1.1|TTDM was defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis was defined as any new lesion that was outside of the radiation field according to RECIST 1.1 or proven by biopsy. TTDM was calculated using the Kaplan-Meier technique.|Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.|FAS included all randomized patients, analyzed on an ITT basis.|||Months||95% Confidence Interval|Median
2604007|NCT02125461|Secondary|Proportion of Patients Alive and Progression Free at 18 Months From (APF18) Based on BICR Assessments According to RECIST 1.1|APF18 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 18 months after randomization per the Kaplan-Meier estimate of PFS at 18 months.|Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.|FAS included all randomized patients, analyzed on an ITT basis.|||Percentage of participants||95% Confidence Interval|Number
2604008|NCT02125461|Secondary|Proportion of Patients Alive and Progression Free at 12 Months From (APF12) Based on BICR Assessments According to RECIST 1.1|APF12 was defined as the percentage of patients who were alive and progression free per RECIST 1.1 at 12 months after randomization per Kaplan-Meier estimate of PFS at 12 months.|Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.|FAS included all randomized patients, analyzed on an ITT basis.|||Percentage of participants||95% Confidence Interval|Number
2604009|NCT02125461|Secondary|Duration of Response (DoR) Based on BICR Assessments According to RECIST 1.1|DoR was defined as the time from date for first documented response of CR or PR until the first documented response of progression per RECIST 1.1 or death in the absence of progression. DoR was calculated using the Kaplan-Meier technique.|Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.|FAS included all randomized patients, analyzed on an ITT basis. Only patients with an objective response were included in the analysis.|||Months||95% Confidence Interval|Median
2604010|NCT02125461|Secondary|Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1|ORR was defined as the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.|Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.|FAS (which included all randomized patients) with measureable disease at baseline, analyzed on an ITT basis.|||Percentage of participants||95% Confidence Interval|Number
2604011|NCT02125461|Primary|Overall Survival|OS was defined as the time from the date of randomization until death due to any cause. OS was calculated using the Kaplan-Meier technique.|From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.|FAS included all randomized patients, analyzed on an ITT basis.|||Months||95% Confidence Interval|Median
2604012|NCT02125461|Primary|Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)|PFS was defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression). Progression was defined using RECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS was calculated using the Kaplan-Meier technique.|Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.|FAS included all randomized patients, analyzed on an intent-to-treat (ITT) basis.|||Months||95% Confidence Interval|Median
2604014|NCT02125292|Secondary|Number of Participants With Potentially Clinically Important Vital Signs|Vital sign assessments included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and body temperature measurements, all measured 6 hours post-dose. Study personnel used both absolute values and change from baseline values to determine if the vital sign was potentially clinically important. Criteria for the potential clinical importance of both absolute and change from baseline values were pre-specified. A participant's vital sign had to meet both the absolute and change from baseline criteria to be considered as potentially clinically important.|1 day|Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||participants|||Number
2604015|NCT02125292|Secondary|Number of Participants With Potentially Clinically Important Laboratory Results|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters, all measured 6 hours post-dose. All clinical laboratory assays were performed according to the laboratory's normal procedures. Reference ranges were supplied by the laboratory and were used to assess the clinical laboratory data for clinical significance and out-of-range pathological changes. The investigator assessed out-of-range clinical laboratory values for clinical significance and indicated whether or not the values were clinically significant.|1 day|Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||participants|||Number
2604016|NCT02125292|Secondary|Number of Participants Who Experienced an Adverse Event|Participants were monitored for treatment-emergent adverse events through the follow-up assessment, which occurred 2 days +/- 1 day post-dose.|4 days|Safety Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||participants|||Number
2604017|NCT02125292|Primary|Number of Participants Willing to Take Mesalamine Via Treatment Method on a Regular Basis|"The participants were asked to answer Yes or No to the following question: Would you be willing to take medicine this way on a regular basis if necessary? The number of participants who answered Yes is reported."|Immediately post-dose|Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.|||participants|||Number
2604018|NCT02125292|Primary|Number of Participants With Positive Responses to Palatability Assessment of The Aftertaste of Mesalamine|"An aftertaste assessment was completed 5 minutes after administration of investigational product to assess the subject's rating of aftertaste and means of administration. The assessment consisted of a 5-point rating scale. The participants were asked to choose one of the following responses to the statement The aftertaste (if present) was acceptable: strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported."|5 minutes post-dose|Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.|||participants|||Number
2604019|NCT02125292|Primary|Number of Participants Who Detected an Aftertaste of Mesalamine|"An aftertaste assessment was completed 5 minutes after administration of investigational product to assess whether the participants detected an aftertaste. The participants answered Yes or No to the following question: Was there an aftertaste? The number of participants who answered Yes is reported."|5 minutes post-dose|Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.|||participants|||Number
2604020|NCT02125292|Primary|Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine|"A taste assessment was completed immediately after investigational product was administered to assess the subject's taste/liking of the formulation. The assessment consisted of a 5-point rating scale. Participants were asked to choose one of the following responses to the statement The taste was acceptable: strongly agree, agree, neutral, disagree, or strongly disagree. The number of participants who chose either of the top two responses (strongly agree, agree) is reported."|Immediately post-dose|Pharmacodynamic Set: all participants who took at least 1 dose of investigational product and had at least 1 post-dose taste assessment.|||participants|||Number
2604021|NCT02125279|Secondary|Change From Baseline in Percent (%) Body Surface Area (BSA) at Each Visit|Percent BSA was calculated by modified rules of nines (pediatric participants). Estimate were made from the following for a child up to the age of one year: head and neck total for front and back - 18%; thorax and abdomen-front -18%; thorax and abdomen-back - 18%; each upper limb total for front and back - 9%; each lower limb total for front and back - 14%. For over the age of one year, the relative percentage of BSA changes as follows: the head decreases by 1% per year and the lower limbs increase by 0.5% per year. By the age of ten years, the relative proportions assume the values for adult BSA as follows: perineum becomes 1%; each lower limb becomes a total of 18% front and back; head and neck become 9% total for front and back.|Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable this outcome measure and 'n' (number of participants analyzed) signifies number of participants evaluable for each time point.|||Percent BSA||Standard Deviation|Mean
2604022|NCT02125279|Secondary|Change From Baseline in Pruritus Score at Each Visit|Pruritus was scored on a 0 to 4 point scale. Where, 0 = none (no-itching); 1 = mild (slight itching, not really bothersome); 2 = moderate (definite itching that is somewhat bothersome without loss of sleep); 3 = severe (intense itching that has caused pronounced discomfort, night rest interrupted); 4 = very severe (very severe itching that has caused pronounced discomfort during the night and daily activities). Positive change from baseline indicate worsening of indication.|Baseline, Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable this outcome measure and 'n' (number of participants analyzed) signifies number of participants evaluable for each time point.|||Units on a scale||Standard Deviation|Mean
2604037|NCT02125279|Primary|Change From Screening in Urine Calcium/Creatinine Ratio at Week 26|Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 26 were reported.|Screening, Week 26|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Ratio||Standard Deviation|Mean
2604023|NCT02125279|Secondary|Number of Participants With Investigator's Global Assessment of Disease Severity (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Each Visit|The IGA is a 0 to 4 point scale. Where, 0 = clear (no signs of psoriasis except for residual hypopigmentation/hyperpigmentation); 1 = almost clear (just perceptible erythema, no induration, and no scaling); 2 = mild (mild erythema, no induration, and mild or no scaling); 3 = moderate (moderate erythema, mild induration, and mild or no scaling); 4 = severe (severe erythema, moderate to severe induration, and scaling of any degree).|Weeks 4, 8, 12, 20, 26 and 30 (Follow-up)|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable this outcome measure and 'n' (number of participants analyzed) signifies number of participants evaluable for each time point.|||Participants|||Count of Participants
2604024|NCT02125279|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as an AE with an onset date on or after the first application of the study drug.|Up to Week 30|Safety population included as all the participants who have applied the study drug at least once.|||Participants|||Count of Participants
2604025|NCT02125279|Primary|Change From Screening in Serum Parathyroid Hormone Levels at Week 30 (Follow-up)|Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 30 were reported.|Screening, Week 30 (Follow-up)|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||pmol/L||Standard Deviation|Mean
2604026|NCT02125279|Primary|Change From Screening in Serum Parathyroid Hormone Levels at Week 26|Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 26 were reported.|Screening, Week 26|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||pmol/L||Standard Deviation|Mean
2604027|NCT02125279|Primary|Change From Screening in Serum Parathyroid Hormone Levels at Week 20|Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 20 were reported.|Screening, Week 20|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||pmol/L||Standard Deviation|Mean
2604028|NCT02125279|Primary|Change From Screening in Serum Parathyroid Hormone Levels at Week 12|Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 12 were reported.|Screening, Week 12|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||pmol/L||Standard Deviation|Mean
2604029|NCT02125279|Primary|Change From Screening in Serum Parathyroid Hormone Levels at Week 8|Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 8 were reported.|Screening, Week 8|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||pmol/L||Standard Deviation|Mean
2604030|NCT02125279|Primary|Change From Screening in Serum Parathyroid Hormone (PTH) Levels at Week 4|Change from screening (the last test prior to the first study medication application) in serum PTH levels at week 4 were reported.|Screening, Week 4|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Picomole per liter (pmol/L)||Standard Deviation|Mean
2604031|NCT02125279|Primary|Change From Screening in Serum Phosphate Levels at Week 30 (Follow-up)|Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 30 were reported.|Screening, Week 30 (Follow-up)|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||mmol/L||Standard Deviation|Mean
2604032|NCT02125279|Primary|Change From Screening in Serum Phosphate Levels at Week 26|Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 26 were reported.|Screening, Week 26|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||mmol/L||Standard Deviation|Mean
2604033|NCT02125279|Primary|Change From Screening in Serum Phosphate Levels at Week 20|Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 20 were reported.|Screening, Week 20|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||mmol/L||Standard Deviation|Mean
2604034|NCT02125279|Primary|Change From Screening in Serum Phosphate Levels at Week 12|Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 12 were reported.|Screening, Week 12|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||mmol/L||Standard Deviation|Mean
2604035|NCT02125279|Primary|Change From Screening in Serum Phosphate Levels at Week 4|Change from screening (the last test prior to the first study medication application) in serum phosphate levels at week 4 were reported.|Screening, Week 4|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||mmol/L||Standard Deviation|Mean
2604038|NCT02125279|Primary|Change From Screening in Urine Calcium/Creatinine Ratio at Week 12|Change from screening (the last test prior to the first study medication application) in urine calcium/creatinine ratio at week 12 were reported.|Screening, Week 12|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Ratio||Standard Deviation|Mean
2604039|NCT02125279|Primary|Change From Screening in Serum Albumin Levels at Week 30 (Follow-up)|Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 30 were reported.|Screening, Week 30 (Follow-up)|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||g/L||Standard Deviation|Mean
2604040|NCT02125279|Primary|Change From Screening in Serum Albumin Levels at Week 26|Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 26 were reported.|Screening, Week 26|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||g/L||Standard Deviation|Mean
2604041|NCT02125279|Primary|Change From Screening in Serum Albumin Levels at Week 20|Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 20 were reported.|Screening, Week 20|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||g/L||Standard Deviation|Mean
2604042|NCT02125279|Primary|Change From Screening in Serum Albumin Levels at Week 12|Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 12 were reported.|Screening, Week 12|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||g/L||Standard Deviation|Mean
2604043|NCT02125279|Primary|Change From Screening in Serum Albumin Levels at Week 8|Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 8 were reported.|Screening, Week 8|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||g/L||Standard Deviation|Mean
2604044|NCT02125279|Primary|Change From Screening in Serum Albumin Levels at Week 4|Change from screening (the last test prior to the first study medication application) in serum albumin levels at week 4 were reported.|Screening, Week 4|Safety population included as all the participants who have applied the study drug at least once. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||gram per liter (g/L)||Standard Deviation|Mean
2604045|NCT02124889|Primary|Adherence to Multivitamin|Percent of anticipated number of doses the patient has taken, as recorded by a Medication Event Monitoring System (MEMS) cap.|50 days||||percentage of doses taken||Standard Error|Mean
2604046|NCT02124863|Primary|Number of Refluxes|Every two hours after feeding, the number of refluxes during 20 minutes are measured. The mean number of refluxes during these periods were calculated and compared to the number of refluxes during 20 minutes of IPV|during 20 minutes of IPV compared to mean number of refluxes during 20 minutes.|All patients receiving IPV were their own controls|||number of refluxes||Standard Deviation|Mean
2604047|NCT02124811|Secondary|Global Assessment of Functioning (GAF) Score|Social, occupational, and psychological functioning was to be assessed using the Global Assessment of Functioning (GAF) in the initial study protocol.|Baseline, Week 12|A protocol amendment removed the GAF outcome measure as this information was determined to be non-essential. To reduce participant burden, data were not collected for this outcome measure.||||||
2604048|NCT02124811|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Score|Perceived quality of life and general well being was assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). The Q-LES-Q-SF is a 16-item questionnaire asking participants to rate how satisfied they have been with heath related qualities on a 5-point scale where 1 = very poor and 5 = very good. Raw scores of the Q-LES-Q-SF range from 14 to 70 and higher scores indicate higher life enjoyment and satisfaction.|Baseline, Week 12|Participants who completed the study are included in this analysis|||units on a scale||Standard Deviation|Mean
2604049|NCT02124811|Primary|General Psychopathology Score of the Positive and Negative Syndrome Scale (PANSS)|General symptoms of schizophrenia/schizoaffective disorder were measured using the general psychopathology subscale of the Positive and Negative Syndrome Scale (PANSS). The PANSS is scored by the clinician-researcher after an interview with the patient and it is the most commonly used measure for assessing the symptoms of schizophrenia. Sixteen items measure general psychopathology symptoms of somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Items are scored on a scale of 1 to 7 where 1 means the symptom is absent and 7 means the symptom is extreme. Total scores for this subscale can range from 16 to 112 where higher scores indicate more severe symptoms. A reduction in the score indicates an improvement in symptom severity.|Baseline, Week 12||||units on a scale||Standard Deviation|Mean
2604060|NCT02124564|Secondary|Percentage of Participants in the Monotherapy Period Without Discontinuation Due to Adverse Events (AE) or Lack of Efficacy (LOE)|For Time to discontinuation (event), Retention rate and 95% CI was calculated using the Kaplan-Meier method. Retention rate is indicated in Percent and 95% confidence intervals (CI) with respect to the Time to discontinuation.|From the beginning of the Monotherapy Period to the end of the Follow-Up Period (up to 3.1 years until the time of approval granted)|The Full Analysis Set (FAS) consisted of subjects in the Safety Set (SS) who had at least 1 seizure diary assessment. Subjects who discontinued before Monotherapy Period were not included in this Analysis.|||Percentage of participant||95% Confidence Interval|Median
2604935|NCT02115386|Secondary|Time to and Duration of CCyR and MMR After Switch From Imatinib to Nilotinib at 24 Months|to evaluate time to achievement and duration of CCyR and MMR after switching from imatinib to nilotinib|at 24 Months|No data collected for this Outcome Measure, as no participants reached month 24||||||
2604050|NCT02124811|Primary|Brief Assessment of Cognition in Schizophrenia (BACS) Score|The Brief Assessment of Cognition in Schizophrenia (BACS) is an instrument that assesses the aspects of cognition found to be most impaired and most strongly correlated with outcomes in patients with schizophrenia (verbal memory, working memory, motor speed, verbal fluency, attention and processing speed, and executive function). BACS takes less than 35 minutes to complete and was administered on an electronic tablet for this study. The composite score is a T-score that averages the standardized scale scores of each of the six tests. The composite T-score has a mean of 50 and a standard deviation of 10. Scores below 50 indicate lower than average cognition while scores above 50 indicate higher than average cognition. A prior study found that the BACS mean composite score for schizophrenia patients was 25.96 while healthy controls had a mean score of 47.00.|Baseline, Week 12|This analysis includes participants who completed the study and who completed the BACS. One participant in the high CRP did not complete this test at either time point.|||units on a scale||Standard Deviation|Mean
2604051|NCT02124811|Primary|Negative Subscale Score of the Positive and Negative Syndrome Scale (PANSS)|Negative symptoms (representing a loss of normal functions) of schizophrenia/schizoaffective disorder were measured with the negative subscale of the Positive and Negative Syndrome Scale (PANSS). The PANSS is scored by the clinician-researcher after an interview with the patient and it is the most commonly used measure for assessing the symptoms of schizophrenia. Seven items measure the negative symptoms of blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity & flow of conversation, and stereotyped thinking. The items are scored on a scale of 1 to 7 where 1 means the symptom is absent and 7 means the symptom is extreme. The total summed score for the negative subscale ranges between 7 and 49 where higher scores indicate more severe symptoms. A reduction in the score indicates an improvement in symptom severity.|Baseline, Week 12|Participants who completed the study are included in this analysis.|||units on a scale||Standard Deviation|Mean
2604052|NCT02124811|Primary|Positive Subscale Score of the Positive and Negative Syndrome Scale (PANSS)|Positive symptoms (representing unusual thought content) of schizophrenia/schizoaffective disorder were measured with the positive subscale of the Positive and Negative Syndrome Scale (PANSS). The PANSS is scored by the clinician-researcher after an interview with the patient and it is the most commonly used measure for assessing the symptoms of schizophrenia. Seven items measure the positive symptoms of delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The items are scored on a scale of 1 to 7 where 1 means the symptom is absent and 7 means the symptom is extreme. The total summed score for the positive subscale ranges between 7 and 49 where higher scores indicate more severe symptoms. A reduction in the score indicates an improvement in symptom severity.|Baseline, Week 12|Participants who completed the study are included in this analysis.|||units on a scale||Standard Deviation|Mean
2604053|NCT02124798|Secondary|Number of Participants Who Reported They Were Successfully Able to Self-administer Their Doses Outside the Clinic Setting in Weeks 3, 5, 6, and 7 (Outside Clinic)|Assessment was performed for suitability of the auto injector for self-administration of belimumab by participant with SLE outside the clinic setting. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections outside of the clinic without assistance were included.|Weeks 3, 5, 6, and 7 (Outside clinic)|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Number
2604054|NCT02124798|Secondary|Number of Participants Successfully Able to Self-administer Their Observed Doses in Weeks 4 and 8 (Inside Clinic)|The main objective was to assess the suitability of the auto injector for self-administration of belimumab by participants with SLE. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections inside and outside of the clinic without assistance were included.|Weeks 4 and 8 (Inside clinic)|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Number
2604055|NCT02124798|Primary|Number of Participants Successfully Able to Self-administer Their Observed First and Second Doses in Weeks 1 and 2 (Inside Clinic)|The primary objective was to assess the suitability of the auto injector for self-administration of belimumab. An overall assessment of usability and reliability for the device was determined by assessing the rate of successfully complete self-administered injections relative to attempted ones. The assessment for the parameter, drug successfully injected was elicited by a Yes/No response. The participants who were able to administer injections inside and outside of the clinic without assistance were included.|Weeks 1 and 2 (Inside clinic)|The intention-to-treat (ITT) population was defined as all participants who were enrolled and treated with at least 1 dose of belimumab. Only those participants with data available at the indicated time points were analyzed.|||Participants|||Number
2604056|NCT02124603|Secondary|Eradication Rate|Number of participants having positive culture at the screening visit with bacterial eradication before surgery|Day of surgery|Number of participants with positive culture at the screening visit|||partecipants|||Number
2604057|NCT02124603|Secondary|Antibiotic Susceptibility|Isolated bacteria were tested for their in vitro susceptibility to commercially available ophthalmic antibiotics by the disk diffusion test and categorized as susceptible, intermediate or resistant.|At least 14 days before surgery|Percentage of isolates susceptibility to antibiotics|||percentage of susceptible isolates|Participants||Number
2604058|NCT02124603|Primary|Positive Culture in Subjects Scheduled for Cataract Surgery|Number of participants with positive culture at the screening visit|At least 14 days before surgery|Number of participants with positive culture|||subjects|||Number
2604059|NCT02124564|Secondary|Plasma Concentrations of Lacosamide Versus Time Postdose|Dose-normalized lacosamide Plasma Concentration (µg/mL) by Visit and Dose during the Evaluation Period.|From Titration Period up to Week 94|Two Subjects withdrew during the AED Withdrawal Period (prior to the Evaluation Period).|||µg/mL||Standard Deviation|Mean
2604119|NCT02123745|Secondary|Significant Skin Irritation or Disruption to Skin Integrity|The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study.|After each participant has been infiltrated, an expected average of 1 hour||||participants|||Number
2604061|NCT02124564|Secondary|Number of Subjects Remaining Seizure Free for 12 Consecutive Months During the Monotherapy Period|"Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the Treatment Period.~A subject was considered seizure free, if no seizure occurred during the 12 consecutive months in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:~A documented seizure during 6 consecutive months of the Evaluation Analysis Period~Subject discontinued the study prematurely during the Evaluation Analysis Period~Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period.~Subjects who discontinued before the end date of 6 consecutive months were included in this analysis."|From the beginning of the Monotherapy Period to the end of the Follow-Up Period (up to 3.1 years until the time of approval granted)|The Full Analysis Set (FAS) consisted of subjects in the SS who had at least 1 seizure diary assessment. Subjects who discontinued before the end date of 12 consecutive months were included in this Analysis.|||Participants|||Count of Participants
2604062|NCT02124564|Secondary|Number of Subjects Remaining Seizure Free for 6 Consecutive Months During the Monotherapy Period|"Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the Treatment Period.~A subject was considered seizure free, if no seizure occurred during the 6 consecutive months in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:~A documented seizure during 6 consecutive months of the Evaluation Analysis Period~Subject discontinued the study prematurely during the Evaluation Analysis Period~Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period"|From the beginning of the Monotherapy Period to the end of the Follow-Up Period (up to 3.1 years until the time of approval granted)|The Full Analysis Set (FAS) consisted of subjects in the Safety Set (SS) who had at least 1 seizure diary assessment. Subjects who discontinued before the end date of 6 consecutive months were included in this analysis.|||Participants|||Count of Participants
2604063|NCT02124564|Primary|Number of Subjects With at Least One Incidence of Serious Adverse Events (SAEs) During the Study|"A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:~Results in death~Is life-threatening~Requires in patient hospitalization or prolongation of existing hospitalization~Is a congenital anomaly or birth defect~Is as infection that requires treatment parenteral antibiotics~Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above"|From the Titration Period (investigational product is taken) to the End of Study Visit (up to 3.5 years)||||Participants|||Count of Participants
2604064|NCT02124564|Primary|Number of Subjects Who Withdraw Due to Adverse Events (AEs) During the Study|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From the Titration Period (investigational product is taken) to the End of Study Visit (up to 3.5 years)||||Participants|||Count of Participants
2604065|NCT02124564|Primary|Number of Subjects With at Least One Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Study|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|From the Titration Period (investigational product is taken) to the End of Study Visit (up to 3.5 years)||||Participants|||Count of Participants
2604066|NCT02124512|Other Pre-specified|Improved Insulin Sensitivity|We hypothesize that a change in the microbial flora with rifaximin will alter plasma LPS, adipose tissue inflammation, and insulin sensitivity. Therefore, we will examine, before and after rifaximin/placebo treatment: 1. LPS associated with lipoproteins, 2. insulin sensitivity and hepatic glucose production, 3. plasma inflammatory markers (TNFα, IL-6, MCP-1, adiponectin), 4. adipose inflammatory markers (CD68, MCP1, TNFα, PAI1, IL12, IL10, TLR4 and others).|Up to 12 weeks|||||||
2604067|NCT02124512|Secondary|Tissue Inflammation|Subjects will undergo a baseline fat biopsy (pre-treatment). They will then be treated with rifaximin for 12 weeks and biopsies will be repeated to determine if disruption of the microbiota reduces tissue inflammation. Data are reported as normalized mRNA expression levels (arbitrary units) of TNFalpha.|Pre-Treatment (baseline) and Post-Treatment (12 weeks after baseline).||||arbitrary units||Standard Error|Mean
2604068|NCT02124512|Primary|Circulating LPS|Plasma lipopolysaccharide (LPS) will be measured both in the fasting state and after a lipid-rich meal in obese subjects (Pre-Treatment: 0, 4 and 8 hr timepoints). The subjects will then be treated with the antibiotic rifaximin for 12 weeks to substantially reduce gut bacteria. LPS measurements at fasting and after a lipid-rich meal will be repeated (Post-Treatment: 0, 4 and 8 hr timepoints). The lipid tolerance tests before and after treatment with rifaximin will be assessed to determine whether there is a reduction in post-prandial LPS. LPS measurements were obtained using a modified LAL Assay.|0, 4 and 8 hours at Baseline, and 0, 4 and 8 hours after 12 weeks of treatment||||EU/mL||Standard Error|Mean
2604069|NCT02124460|Post-Hoc|Parent Very Satisfied With Information he/She Received About Resources in the Community|This is a feasibility and acceptability measure from the study.|1 year|The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses. Additionally, only those who responded Yes to the previous question asking if they received community resources were included in this analysis.|||Participants|||Count of Participants
2604070|NCT02124460|Post-Hoc|Received Text Messages or Emails From Connect 4 Health|This is a feasibility and acceptability measure from the study.|1 year|The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses.|||Participants|||Count of Participants
2604071|NCT02124460|Post-Hoc|Received Information From Connect 4 Health About Resources in the Community|This is a feasibility and acceptability measure from the study.|1 year|The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses.|||Participants|||Count of Participants
2604072|NCT02124460|Post-Hoc|Parent Very Satisfied With Content of Connect 4 Health Text Messages or Emails.|This is a feasibility and acceptability measure from the study.|1 year|The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses. Additionally, only those who responded Yes to the previous question asking if they received text messages were included in this analysis.|||Participants|||Count of Participants
2604073|NCT02124460|Post-Hoc|Increased Satisfaction With Care at Harvard Vanguard Medical Associates (HVMA)|This is a feasibility and acceptability measure from the study.|1 year|The number of participant analyzed was based only on those who completed the follow-up survey (as the questions were not asked at baseline) and excluded those with missing responses.|||Participants|||Count of Participants
2604074|NCT02124460|Secondary|Change in Consumption of Sugar-sweetened Beverages and Juice|Number of time child consumed juice (e.g., orange juice, apple juice, or grape juice), fruit-flavored drinks (e.g., Kool-Aid, sports drinks, Goya juice, etc.), regular soda, soft drinks, or Malta yesterday.|baseline and 1 year||||times/day||95% Confidence Interval|Mean
2604075|NCT02124460|Secondary|Change in Fruit and Vegetable Consumption|Number of times the child consumed of vegetables and fruits yesterday|baseline and 1 year||||times/day||95% Confidence Interval|Mean
2604076|NCT02124460|Secondary|Change in Physical Activity|In the past week, how many days the child was physically active for a total of at least 60 minutes per day.|baseline and 1 year||||days/week||95% Confidence Interval|Mean
2604077|NCT02124460|Secondary|Change in Sleep|Average hours/day spent sleeping|baseline and 1 year||||hours/day||95% Confidence Interval|Mean
2604078|NCT02124460|Secondary|Change in Screen Time|Average hours/day spent watching television, videos, or playing games displayed on media such as television, desktop computers, laptops, portable DVD players, iPads or smartphones.|baseline and one year||||hours/day||95% Confidence Interval|Mean
2604079|NCT02124460|Primary|Change in Parent Resource Empowerment|The five items in the scale assessed parents' perceived knowledge of resources, ability to access resources, comfort with accessing resources, knowledge of how to find resources, and ability to acquire resources related to child weight management. For each question, parents responded strongly disagree, disagree, agree, or strongly agree, which were worth 1 to 4 points, respectively. Items were averaged to create a summary parental resource empowerment score (range= 1-4), where a higher score indicated greater perceived knowledge and ability to access resources related to weight management. Cronbach's α for this score was 0.87.|Baseline to one-year follow-up||||units on a scale||95% Confidence Interval|Mean
2604080|NCT02124460|Primary|Change in Quality of Life|The PedsQL is an extensively validated, widely used, 23-item measure of health-related quality of life in children with chronic conditions such as obesity. Parents will be asked to complete 4 subscales: physical health, school, social, and emotional functioning which exists for parental report of children as young as 2 years of age. Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better HRQOL. Scale Scores are computed as the sum of the items divided by the number of items answered (this accounts for missing data). If more than 50% of the items in the scale are missing, the Scale Score is not computed.|baseline and one year||||units on a scale||95% Confidence Interval|Mean
2604081|NCT02124460|Primary|Change in BMI z Score|Height and weight will be measured by the medical assistants at each site using standard protocols. BMI measures will be obtained from the electronic health record (EHR) as provided through usual care. BMI measures will be converted to z-scores using CDC age and sex-specific normative data for children between 2 and 20 years old. This will allow the research team to combine data across children of different ages.|baseline and one year||||BMI z score units||95% Confidence Interval|Mean
2604082|NCT02124304|Secondary|Perceived Exertion|Thera-Band(R) RISE (Resistance Intensity Scale for Exercise) Scale to measure amount of perceived exertion during resistance band exercises. Participants were asked to rate the intensity of an exercise on a scale from 0 to 10, 0 being no resistance and 10 being the maximum resistance.|12 exercises during one 1 hour session||||units on a scale, ranging from 0 to 10||Full Range|Mean
2604083|NCT02124304|Primary|Percent of Peak Activation (%PA)|8 muscles during 12 exercises were analyzed in 30 subjects, totaling 2880 data points. At the beginning of the study, peak activation (PA) was assessed for each muscle during full flexion-extension, used as a reference exercise. For each subject, the EMG signals of the muscles during the 12 exercises were smoothed, rectified and analyzed using a root-mean-square algorithm and the greatest activation of each muscle was used. After the PA for each muscle was determined, it was compared to the PA of the reference exercise for the respective muscle group, and expressed as a percent of the peak activation (%PA). In some cases the %PA is greater than 100%. This is possible as the PA was assessed during a full flexion-extension movement. During an exercise some muscles generated greater PA and therefore when the calculations were performed the %PA was greater than 100%. Due to the extensive amount of data, we have provided the Left Cervical Paraspinals %PA results for each exercise.|One 1 hour session||||Percentage of Peak Activation (%PA)||Full Range|Mean
2604084|NCT02124265|Primary|Number of Participants With a 20% Decrease in Required IV Fluid.|"Number of participants whose IV fluids were reduced to less than or equal to 80% of the Parkland Goal IV resuscitation formula within the first 24 hours of initial burn injury.~To test the efficacy and safety of Oral RehydrationTherapy in resuscitation of burn patients"|24 hours post-burn|All participants who received the treatment (Ceralyte 90)|||participants|||Number
2604085|NCT02124161|Secondary|Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1|"Fold rise 1 month after Vaccination 1 to before Vaccination 1 was calculated for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). GMFRs were calculated using all participants with available data from both the specified blood draws. CI for the GMFRs were back transformations of a CI based on the Student t distribution for mean fold rise. Here, number of participants analyzed signifies participants with valid and determinate assay results for specified strain at both the specified blood draws."|Immediately before Vaccination 1, 1 month after Vaccination 1|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.|||fold rise||95% Confidence Interval|Geometric Mean
2604086|NCT02124161|Secondary|Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers|"Percentage of participants achieving seroconversion in HAI titers was defined as the percentage of participants with either before Vaccination 1 (pre-vaccination 1) HAI titer less than <1:10 and after Vaccination 1 (post-vaccination 1) HAI titer >=1:40 or before Vaccination 1 (pre-vaccination 1) HAI titer >=1:10 and a minimum 4-fold rise in after Vaccination 1 (post-vaccination 1) HAI antibody titer with respect to before Vaccination 1 (pre-vaccination) titer for influenza virus strains. Here, number of participants analyzed signifies the participants who were evaluable at this timepoint."|Immediately before Vaccination 1, 1 month after Vaccination 1|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2604087|NCT02124161|Secondary|Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 2 to before Vaccination 2 (1 month after Vaccination 1) were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 2 and 1 month after Vaccination 2 blood draws. Here, number of participants analyzed signifies total participants who were evaluable at this timepoint and n signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 2 were analyzed."|Immediately before Vaccination 2, 1 month after Vaccination 2|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.|||fold rise||95% Confidence Interval|Geometric Mean
2604088|NCT02124161|Secondary|Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1|"GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 1 to before Vaccination 1 were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 1 and 1 month after Vaccination 1 blood draws. Here, n signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 1 were analyzed."|Immediately before Vaccination 1, 1 month after Vaccination 1|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.|||fold rise||95% Confidence Interval|Geometric Mean
2604089|NCT02124161|Secondary|Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)|"Percentage of participants achieving predefined OPA antibody titer >= LLOQ for each of the 13 pneumococcal serotypes (LLOQs for each serotype OPA were set as- serotype 1: 18; serotype 3: 12; serotype 4: 21; serotype 5: 29; serotype 6A: 37; serotype 6B: 43; serotype 7F: 210; serotype 9V: 345; serotype 14: 35; serotype 18C: 31; serotype 19A: 18; serotype 19F: 48; and serotype 23F: 13) determined in blood samples of all participants were calculated. Exact, 2-sided 95% CIs based on the observed percentage of participants were determined by using Clopper and Pearson method. OPA titers were calculated using all participants with available data from 1 month after 13vPnC vaccination blood draw. Here, number of participants analyzed signifies the participants who were evaluable at this timepoint and n signifies participants with valid and determinate assay results to the specified serotype."|1 Month After Vaccination 1 for 13vPnC+QIV/Placebo, 1 month after Vaccination 2 for Placebo+QIV/13vPnC|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2604090|NCT02124161|Primary|Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Within 168 to 196 days after Vaccination 2|Safety population included all participants who received at least 1 dose of vaccination.|||percentage of participants|||Number
2604091|NCT02124161|Primary|Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Baseline (Vaccination 1) up to 28 to 42 Days after Vaccination 2|"Safety population included all participants who received at least 1 dose of vaccination. Here, number of participants analyzed signifies participants who were evaluable at this timepoint."|||percentage of participants|||Number
2604120|NCT02123745|Secondary|Infiltrated Volume When Yellow Notification Issued|The amount of infiltrated isotonic saline solution when the yellow notification was issued by the ivWatch Model 400 device.|After each participant has been infiltrated, an expected average of 1 hour||||mL|Participants|Standard Deviation|Mean
2604092|NCT02124161|Primary|Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Within 28 to 42 days after Vaccination 2|"Safety population included all participants who received at least 1 dose of vaccination. Here, number of participants analyzed signifies participants who were evaluable at this timepoint."|||percentage of participants|||Number
2604093|NCT02124161|Primary|Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Within 28 to 42 days after Vaccination 1|Safety population included all participants who received at least 1 dose of vaccination.|||percentage of participants|||Number
2604094|NCT02124161|Primary|Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)|"HAI GMTs were computed for assay titers collected 1 month after Vaccination 1 by vaccine sequence for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). CIs were back-transformations of a CI based on the Student t distribution for the mean logarithm of the titers. HAI GMTs were calculated using all participants with available data for the specified blood draw. Here, number of participants analyzed signifies participants with a determinate HAI titer to the given strain."|1 month after Vaccination 1|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
2604095|NCT02124161|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes|"Serotype-specific OPA GMTs for each of the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were logarithmically transformed for analysis. Confidence intervals (CIs) for GMT were back-transformed based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here, number of participants analyzed signifies the participants who were evaluable at this timepoint and n signifies participants with a determinate OPA titer to the given serotype."|1 month after Vaccination 1 for 13vPnC+QIV/Placebo, 1 Month After Vaccination 2 for Placebo+QIV/13vPnC|Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
2604096|NCT02124122|Primary|Mean Daily Temperature|Mean of body temperatures recorded on study days listed, averaged across all participants at all time points|Study days 1-5, 8,12, 15, 18, 28, and 36||||Degrees Celsius||Standard Deviation|Mean
2604097|NCT02124122|Primary|Number of Participants With Positive Blood Culture for L Reuteri||Participants are followed an average of 36 days||||Participants|||Count of Participants
2604098|NCT02124083|Primary|Number of Participants With Tolerabilty of 400 mg Vorinostat in Niemann-Pick Disease, Type C1|The number of Niemann-Pick Disease, type C1 patients completing 3 month 400 mg phase|3 months|All participants completing 200 mg phase and starting 400 mg phase|||Participants|||Number
2604099|NCT02124083|Primary|Number of Participants With Tolerabilty of 200 mg Vorinostat in Niemann-Pick Disease, Type C1|The number of Niemann-Pick Disease, type C1 patients completing 3 month 200 mg phase|3 months|All participants who started study|||Participants|||Number
2604100|NCT02124083|Secondary|Biochemical Efficacy as Measured by Serum LGALS3|Serum concentration of LGALS3 (galectin-3). Galectin-3 is a carbohydrate-binding lectin whose expression is associated with inflammatory cells including macrophages, neutrophils, and mast cells. LGALS3 normal range = 1.4-5.3 ng/ml.|Baseline|All participants who started study|||ng/mL||Standard Deviation|Mean
2604101|NCT02124083|Secondary|Biochemical Efficacy as Measured by Serum LGALS3|Serum concentration of LGALS3 (galectin-3). Galectin-3 is a carbohydrate-binding lectin whose expression is associated with inflammatory cells including macrophages, neutrophils, and mast cells. LGALS3 normal range = 1.4-5.3 ng/ml.|6 months|All participants completing both 200 and 400 mg phases|||ng/mL||Standard Deviation|Mean
2604102|NCT02124083|Secondary|Biochemical Efficacy as Measured by Serum Cathepsin D|Serum concentration of Cathepsin D. Cathepsin D is an aspartyl protease involved in protein catabolism and tissue remodeling. Cathepsin D normal range = 220-515 ng/ml.|Baseline|All participants who started study|||ng/mL||Standard Deviation|Mean
2604103|NCT02124083|Secondary|Biochemical Efficacy as Measured by Serum Cathepsin D|Serum concentration of Cathepsin D. Cathepsin D is an aspartyl protease involved in protein catabolism and tissue remodeling. Cathepsin D normal range = 220-515 ng/ml.|6 months|All participants completing both 200 and 400 mg phases|||ng/mL||Standard Deviation|Mean
2604104|NCT02124044|Primary|The Percentage of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs|The primary outcome was the percentage of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than 43 IU/mL - the lower limit of quantification.|12 weeks after stop of treatment|Subjects who received treatment drugs per arm as listed in the Outcome Measure Description|||Percentage of subjects|||Number
2604105|NCT02124018|Secondary|Total Mortality|All-cause mortality|From completion of risk stratification to study completion or outcome occurrence (mean 32 months)||||Participants|||Count of Participants
2604121|NCT02123745|Secondary|Infiltrated Volume When Red Notification Issued|The amount of infiltrated isotonic saline solution when the red notification was issued by the ivWatch Model 400 device.|After each participant has been infiltrated, an expected average of 1 hour||||mL|Participants|Standard Deviation|Mean
2604106|NCT02124018|Primary|Number of Participants With Major Arrhythmic Events (MAEs) - Present When One of the Following Occurred: Sudden Cardiac Death, Sustained Ventricular Tachycardia, or Implantable Cardioverter - Defibrillator (ICD) Activation|The number of patients from each risk level group meeting the primary endpoint will be used to assess diagnostic accuracy (positive/negative predictive value, sensitivity and specificity) of the proposed two-stage, PVS-inclusive, risk stratification approach for the allocation of an ICD|From stratification completion (i.e. allocation to one of three risk level groups) until either occurrence of primary endpoint or study completion (mean 32months) - study stopped early due to emergence of clearly defined high risk subgroup||||participants|||Number
2604107|NCT02123966|Secondary|Change Pre-to-post Treatment in Oral Health Impact Profile Assessment|Oral health related quality of life will be assessed before and after topical sirolimus therapy using the 14-item Oral Health Impact Profile instrument that measures subject's perceptions of the impact of oral conditions on their well-being.|Pre treatment and after the 28 day (4 weeks) cycle of treatment|Data was not accessible and therefore the analysis was not conducted.||||||
2604108|NCT02123966|Primary|Percentage of Participants With a Subjective Sensitivity Score Response|"The sensitivity score is one question on a self-reported assessment tool from the NIH consensus documents. The question asks: Your mouth sensitivity at its WORST with a score 0-10, 10 being the worst. Response was defined as a 3 point reduction in sensitivity score from pre-to-post treatment."|Pre treatment and after the 28 day (4 weeks) cycle of treatment|The analysis population is comprised of all treated participants.|||percentage of participants||90% Confidence Interval|Number
2604109|NCT02123849|Secondary|Change in Buccal Cells Via Karyometric Analysis||Baseline to up to one week post-intervention|Data were not collected||||||
2604110|NCT02123849|Secondary|Whole-genome Gene Expression - Number of Canonical Pathways Differentially Expressed|Gene set enrichment analysis was performed on the MSigDB canonical pathways with the intent to discover differentially expressed genes after aspirin intervention.|Baseline to 12 weeks|The number of participants analyzed is different from the numbers provided in the Participant Flow Module because gene expression analysis was restricted to samples that met quality metrics.|||canonical pathway|||Number
2604111|NCT02123849|Secondary|Persistence of the Change in the Smoking-related Gene Expression Signature Score in the Nasal Epithelium One Week Off Agent Intervention|Change in nasal smoking-related gene expression signature score from baseline to 1 week post-intervention was compared between the two study arms. Prior research showed that a higher score was observed in never smokers compared to current smokers. An increased score implicated a more favorable intervention effect. There is no minimum or maximum score.|Baseline to 1 week post-intervention|The number of participants analyzed is different from the numbers provided in the Participant Flow Module because gene expression analysis was restricted to samples that met quality metrics.|||gene expression signature score||Standard Deviation|Mean
2604112|NCT02123849|Secondary|Persistence of the Change in the Lung Cancer-related Gene Expression Signature Score in the Nasal Epithelium One Week Off Agent Intervention|Change in the lung cancer-related gene expression signature score from baseline to one week off agent intervention was compared between the two study arms. Prior research showed that higher scores were observed in lung cancer cases than healthy controls. A decreased score implicated a favorable intervention effect. There is no minimum or maximum score.|Baseline to 1 week post-intervention|The number of participants analyzed is different from the numbers provided in the Participant Flow Module because gene expression analysis was restricted to samples that met quality metrics.|||gene expression signature score||Standard Deviation|Mean
2604113|NCT02123849|Secondary|Changes in Lung Cancer-related Gene Expression Signature Score in the Nasal Epithelium|Change in lung cancer-related gene expression signature score derived from prior research was compared between the two study arms. Prior research showed that the score was higher in lung cancer cases than healthy controls. A decreased score implicated a more favorable intervention effect. There is no minimum or maximum score.|Baseline to 12 weeks (End-of-Intervention)|The number of participants analyzed is different from the numbers provided in the Participant Flow Module because gene expression analysis was restricted to samples that met quality metrics.|||gene expression signature score||Standard Deviation|Mean
2604114|NCT02123849|Secondary|Gender Effect on Smoking-related Gene Expression Signature Score|Change in nasal smoking-related gene expression signature score was compared between male and female participants. The gender comparison was not stratified by arm because of the small sample size. Prior research showed that a higher score was observed in never smokers compared to current smokers. An increased score implicated a more favorable intervention effect. There is no minimum or maximum score.|Baseline to 12 weeks (End-of-Intervention)|The number of participants analyzed is different from the numbers provided in the Participant Flow Module because gene expression analysis was restricted to samples that met quality metrics.|||gene expression signature score||Standard Deviation|Mean
2604115|NCT02123849|Secondary|Number of Participants Experiencing Possibly/Probably/Definitely-related Adverse Events||Up to 2 weeks post-treatment||||Participants|||Count of Participants
2604116|NCT02123849|Secondary|Changes in Urine Prostaglandin E2 Metabolite (PGE-M) Levels|Urinary PGE-M was used as a biomarker of cyclooxygenase (COX) mediated arachidonic acid metabolism. Decreased PGE-M implicated inhibition of COX mediated pathway.|Baseline to 12 weeks (End-of-Intervention)||||ng/mg creatinine||Standard Deviation|Mean
2604117|NCT02123849|Secondary|Changes in Urine Leukotriene E4 (LTE(4)) Levels|Urinary LTE(4) was used as a biomarker 5-lipoxygenase (5-LOX) mediated arachidonic acid metabolism. Decreased LTE4 implicated inhibition of the 5-LOX mediated pathway.|Baseline to 12 weeks (End-of-Intervention)||||pg/mg creatinine||Standard Deviation|Mean
2604118|NCT02123849|Primary|Changes in Smoking-related Gene Expression Signature Score in Nasal Epithelium|Change in nasal smoking-related gene expression signature score derived from prior research was compared between the two study arms. Prior research showed that a higher score was observed in never smokers compared to current smokers. An increased score implicated a more favorable intervention effect. There is no minimum or maximum score.|Baseline to 12 weeks (End-of-Intervention)|The number of participants analyzed is different from the numbers provided in the Participant Flow Module because gene expression analysis was restricted to samples that met quality metrics.|||gene expression signature score||Standard Deviation|Mean
2605440|NCT02109445|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-03084014, Nab-P and GEM in Phase 2||Cycle 1 Day 1 till end of last cycle|As Phase 2 was not performed, no participants were analyzed for this outcome measure.||||||
2604123|NCT02123745|Primary|Red Notification Sensitivity to Infiltrated Tissues|The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.|After each participant has been infiltrated, an expected average of 1 hour||||percentage of infiltrations|Participants|95% Confidence Interval|Number
2604124|NCT02123576|Secondary|Overall Survival|This will be the combination of transplant free survival and those patients who received liver transplant|up to 1 year||||days||Full Range|Mean
2604125|NCT02123576|Secondary|Transplant Free Survival||day 30 and 180||||days||Full Range|Mean
2604126|NCT02123576|Secondary|Number of Participants With Combined Outcome of Treatment Success and Partial Response|We define as serum creatinine level decreased by >50% from baseline but not to <1.5 mg/dL, without dialysis or HRS recurrence|14 days||||Participants|||Count of Participants
2604127|NCT02123576|Secondary|Incidence of Treatment Failure|Defined as creatinine level above baseline value after day 7, dialysis or death|up to day 14||||Participants|||Count of Participants
2604128|NCT02123576|Secondary|Change in Serum Creatinine From Baseline||baseline and 14 days||||g/dL||Full Range|Mean
2604129|NCT02123576|Primary|Number of Participants With Treatment Success|We define this as a decrease in serum creatinine level to <1.5 mg/dL without dialysis or death|14 days||||Participants|||Count of Participants
2604130|NCT02123511|Secondary|Adverse Event, as Measured by the Number of Patients With a Maximum Grade of Any Adverse Event|The maximum grade for each type of toxicity will be recorded for each patient. The overall adverse event rates (percentages) for adverse events are reported below.|Up to 90 days after completion of radiation therapy||||Participants|||Count of Participants
2604131|NCT02123511|Secondary|EORTC Quality of Life Questionnaire (QLQ) H&N Sticky Saliva AUC|Average Area Under the Curve per assessment (aAUCpa) of QLQ H&N35 subscales including pain, swallowing, teeth, opening mouth, dry mouth, sticky saliva, senses problems, coughing, speech problems, felt ill, trouble with social contact, trouble with social eating, less sexuality, pain killers, nutritional supplements, feeding tube, weight loss, & weight gain. The QLQ H&N35 scoring algorithm was used for sticky saliva (question 42) on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient & subscale, the subscale values at treatment-initiation & assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale.|Up to 90 days after completion of radiation therapy|Patients who completed the QLQ H&N Sticky Saliva at all specified time points are included in this analysis.|||score on a scale||Standard Deviation|Mean
2604132|NCT02123511|Secondary|EORTC Quality of Life Questionnaire (QLQ) Swallowing|Average Area Under the Curve per assessment (aAUCpa) of QLQ H&N35 subscales including pain, swallowing, teeth, opening mouth, dry mouth, sticky saliva, senses problems, coughing, speech problems, felt ill, trouble with social contact, trouble with social eating, less sexuality, pain killers, nutritional supplements, feeding tube, weight loss, & weight gain. The QLQ H&N35 scoring algorithm was used for swallowing (questions 35-38) on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient & subscale, the subscale values at treatment-initiation & assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale.|Up to 90 days after completion of radiation therapy|Patients who completed the QLQ H&N Swallowing at all specified time points are included in this analysis.|||score on a scale||Standard Deviation|Mean
2604133|NCT02123511|Secondary|EORTC Quality of Life Questionnaire (QLQ) H&N Pain AUC|Average Area Under the Curve per assessment (aAUCpa) of QLQ H&N35 subscales including pain, swallowing, teeth, opening mouth, dry mouth, sticky saliva, senses problems, coughing, speech problems, felt ill, trouble with social contact, trouble with social eating, less sexuality, pain killers, nutritional supplements, feeding tube, weight loss, and weight gain. The QLQ H&N35 scoring algorithm was used for pain (questions 31-34) on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale.|Up to 90 days after completion of radiation therapy|Patients who completed the QLQ H&N Pain at all specified time points are included in this analysis.|||score on a scale||Standard Deviation|Mean
2604134|NCT02123511|Secondary|GRIX Xerostiomia Total Score AUC|GRIX Xerostiomia Total Score AUC. The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance).|Up to 90 days after completion of radiation therapy|Patients who completed the GRIX Xerostomia Total Score at all specified time points are included in this analysis.|||score on a scale||Standard Deviation|Mean
2604144|NCT02123459|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2605276|NCT02111252|Secondary|GMT of Single Radial Hemolysis (SRH) Antibody Titer|GMT of single radial hemolysis (SRH) antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.|Day 22|The full analysis set was used.|||mm^2||95% Confidence Interval|Geometric Mean
2604135|NCT02123511|Secondary|GRIX Xerostomia Nighttime AUC|GRIX Xerostomia Nighttime AUC. The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance).|Up to 90 days after completion of radiation therapy|Patients who completed the GRIX Xerostomia Nighttime at all specified time points are included in this analysis.|||score on a scale||Standard Deviation|Mean
2604136|NCT02123511|Secondary|GRIX Xerostomia Daytime AUC|GRIX Xerostomia Daytime AUC. The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance).|Up to 90 days after completion of radiation therapy|Patients who completed the GRIX Xerostomia Daytime at all specified time points are included in this analysis.|||score on a scale||Standard Deviation|Mean
2604137|NCT02123511|Secondary|Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Nighttime Area Under the Curve (AUC).|Groningen Radiotherapy-Induced Xerostomia (GRIX) sticky saliva Nighttime Area under the curve (AUC).The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance).|Up to 90 days after completion of radiation therapy|evaluable for Primary Endpoint we included in this analysis.|||score on a scale||Standard Deviation|Mean
2604138|NCT02123511|Secondary|Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Daytime Area Under the Curve (AUC)|Groningen Radiotherapy-Induced Xerostomia (GRIX) sticky saliva Daytime Area under the curve (AUC).The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance).|Up to 90 days after completion of radiation therapy|evaluable for Primary Endpoint we included in this analysis.|||score on a scale||Standard Deviation|Mean
2604139|NCT02123511|Primary|Groningen Radiotherapy-Induced Xerostomia (GRIX) Sticky Saliva Total Score Area Under the Curve (AUC)|Groningen Radiotherapy-Induced Xerostomia (GRIX) sticky saliva total score Area under the curve (AUC).The GRIX questionnaire is a 14-item questionnaire with four subscales on 0-100 scales with higher scores representing worse symptoms. The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the end of radiotherapy. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to the end of their radiotherapy are averaged to yield the aAUCpa per patient per subscale. AUC will be calculated for each patient from baseline to two weeks following radiotherapy. The AUC values will be compared between the two arms using t-test (equal variance).|Up to 2 weeks following radiotherapy|evaluable for Primary Endpoint (AUC for GRIX Sticky Saliva Total Score)|||score on a scale||Standard Deviation|Mean
2604140|NCT02123472|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||Microgram per milliliter(μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2604141|NCT02123472|Secondary|Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||Hours||Standard Deviation|Median
2604142|NCT02123472|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||hour*microgram per milliliter (h*µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2604143|NCT02123459|Secondary|Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||Hours||Standard Deviation|Median
2605576|NCT02108171|Other Pre-specified|Time to Consciousness of Patients Receiving Intranasal Dexmedetomidine|Time to consciousness of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and consciousness.|1 day||||minutes|||Number
2604145|NCT02123459|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||Hours*microgram per milliliter(h*μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2604146|NCT02123446|Secondary|Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable PK data.|||hours||Standard Deviation|Median
2604147|NCT02123446|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||Microgram per milliliter(µg/ml)||Geometric Coefficient of Variation|Geometric Mean
2604148|NCT02123446|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve of Cephalexin From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||Hour*microgram per milliliter(h*µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2604149|NCT02123329|Secondary|Health Related Quality of Life|Mean change in health related quality of life score from baseline to 6 months for quitters vs. non quitters|6 month|Unfortunately patients didnt return at 6 months to fill the QOL questionnaire this is why we dont have data to report on this measure||||||
2604150|NCT02123329|Primary|Objective Smoking Abstinence|Smoking abstinence as objectively verified by the CO exhaled test at 12 months|12 months||||Participants|||Count of Participants
2604151|NCT02123329|Primary|Self-reported Continuous Abstinence|Defined as having smoked no cigarettes since quit day at 12 months|12 months||||participants|||Number
2604152|NCT02123329|Primary|Self-reported 30-day Point Prevalence Abstinence|Defined as having smoked no cigarettes in the last 30 days|12 months||||Participants|||Count of Participants
2604153|NCT02123329|Primary|Self-reported 7-day Point Prevalence Abstinence|Defined as having smoked no cigarettes for the previous 7 days|12 months||||Participants|||Count of Participants
2604154|NCT02123329|Primary|Self-reported Continuous Abstinence|Defined as having smoked no cigarettes since quit day|6 months||||Participants|||Count of Participants
2604155|NCT02123329|Primary|Self-reported 30-day Point Prevalence Abstinence|Defined as having smoked no cigarettes in the last 30 days|6 months||||Participants|||Count of Participants
2604156|NCT02123329|Primary|Self-reported 7-day Point Prevalence Abstinence|Defined as having smoked no cigarettes for the previous 7 days|6 months||||Participants|||Count of Participants
2604157|NCT02123329|Primary|Self-reported Continuous Abstinence at 3 Months|Self-reported continuous abstinence defined as having smoked no cigarettes since quit day|3 months||||Participants|||Count of Participants
2604158|NCT02123329|Primary|Self-reported 30 Day Smoking Abstinence|Self-reported 30-day point prevalence abstinence defined as having smoked no cigarettes in the last 30 days|3 months||||Participants|||Count of Participants
2604159|NCT02123329|Primary|Self-reported 7-day Point Prevalence Abstinence|Self-reported 7-day point prevalence abstinence, defined as having smoked no cigarettes for the previous 7 days|3 months||||Participants|||Count of Participants
2604160|NCT02123251|Secondary|Change From Baseline to End of Intervention (December 2015) in Physical Component Summary Measure of the Short Form (SF-36v2) Health Survey|The SF-36v2 is validated, self reported short-form health survey used to assess changes over time in the well-being of participants. It consists of 2 component summary measures that further summarize 8 health domain scales. The Physical Component Summary (PCS) measure is derived from domain scales of Physical Functioning (10 items), Role-Physical (4 items), Bodily Pain (2 items), and General Health (5 items). Scores of component summary measures and health domain scales range from 0 to 100 with higher scores indicating better outcomes. Norm-based scoring was used so that scores for each health domain scale and component summary measure have a mean of 50 and standard deviation of 10 based on the 2009 U.S. general population. The SF-36v2 was used to assess participants' health and wellbeing at baseline, mid, and endpoint of intervention. Change = (Midpoint Score - Baseline Score)|Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment|Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model; this provides unbiased results when the type of missing data is random. Not all participants submitted surveys at each data point.|||units on a scale||95% Confidence Interval|Least Squares Mean
2604161|NCT02123251|Secondary|Change From Baseline to End of Intervention (December 2015) in General Diet Subscale of The Summary of Diabetes Self-Care Activities (SDSCA) Measure|SDSCA is a validated, self-reported measure assessing the average # of days the recommended diabetes self-care activities are performed over the past 7 days in the areas of general diet, specific diet, exercise, blood-glucose testing, and foot care at baseline, mid, and end of intervention. Possible scores range from 0 to 7 days. Change = (End of Intervention Score - Baseline Score)|Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment|Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model; this provides unbiased results when missing data is random. Not all participants submitted surveys at each data point.|||units on a scale||95% Confidence Interval|Least Squares Mean
2604162|NCT02123251|Secondary|Changes in Health Utilization Cost Before and During Intervention - Amount Paid by Service Providers|Changes of total cost expenditures including emergency room use and hospitalizations in the intervention and control groups before and during intervention.|Before intervention (3 years prior to baseline) and during intervention (2 years from baseline to end of intervention)||||dollars/day||Standard Error|Mean
2604714|NCT02117687|Secondary|Study Product Use|The number of times the study product is administered per day is recorded.|Day 8, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Number of Times/Day||Standard Deviation|Mean
2604163|NCT02123251|Primary|Changes in HDL From Baseline to the End of Intervention (December 2015)|Changes in HDL from baseline to end of study. Change = (End of Intervention score - Baseline score)|Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment|Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.|||mg/dL||95% Confidence Interval|Least Squares Mean
2604164|NCT02123251|Primary|Changes in LDL From Baseline to the End of Intervention (December 2015)|Changes in LDL from baseline to end of study. Change = (End of Intervention score - Baseline score)|Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment|Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.|||mg/dL||95% Confidence Interval|Least Squares Mean
2604165|NCT02123251|Primary|Changes in Triglycerides From Baseline to the End of Intervention (December 2015)|Changes in triglycerides from baseline to end of study. Change = (End of Intervention score - Baseline score)|Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment|Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.|||mg/dL||95% Confidence Interval|Least Squares Mean
2604166|NCT02123251|Primary|Changes in Total Cholesterol From Baseline to the End of Intervention (December 2015)|Changes in total cholesterol from baseline to end of study. Change = (End of Intervention score - Baseline score)|Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment|Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.|||mg/dL||95% Confidence Interval|Least Squares Mean
2604167|NCT02123251|Primary|Changes in Diastolic Blood Pressure From Baseline to the End of Intervention (December 2015)|Changes in diastolic blood pressure from baseline to end of study. Change = (End of Intervention score - Baseline score)|Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment|Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.|||mmHg||95% Confidence Interval|Least Squares Mean
2604168|NCT02123251|Primary|Changes in Systolic Blood Pressure From Baseline to the End of Intervention (December 2015)|Changes in systolic blood pressure from baseline to end of study. Change = (End of Intervention score - Baseline score)|Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment|Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.|||mmHg||95% Confidence Interval|Least Squares Mean
2604169|NCT02123251|Primary|Changes in HbA1c From Baseline to the End of Intervention (December 2015)|Changes in Hemoglobin A1c from baseline to end of study. Change = (End of Intervention score - Baseline score)|Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment|Repeated measurements for each subject were used. The analysis was per protocol with all available observations for each subject included to estimate parameters in the mixed effects model. The mixed effects model approach can provide unbiased results when the type of missing data is missing at random, which is common for longitudinal studies.|||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
2604170|NCT02123134|Primary|Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG)|The SMSLG is an integration of three features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds). Each grade (1=none, 2=mild, 3=moderate and 4=severe) defines the maximal allowed limit for skin wrinkling, adherence to underlying structures and redundancy.|Baseline and up to Week 32 (12 weeks after last treatment)|ITT population included all randomized participants, whether or not they received the assigned study drug.|||scores on a scale||Standard Deviation|Mean
2604171|NCT02123134|Primary|Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)|The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).|Baseline and up to Week 32 (12 weeks after last treatment)|ITT population included all randomized participants, whether or not they received the assigned study drug.|||percentage of participants||95% Confidence Interval|Number
2604172|NCT02123134|Primary|Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS)|The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).|Baseline and up to Week 32 (12 weeks after last treatment)|ITT population included all randomized participants, whether or not they received the assigned study drug.|||percentage of participants||95% Confidence Interval|Number
2604173|NCT02123134|Primary|Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)|The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).|Baseline and up to Week 32 (12 weeks after last treatment)|ITT population included all randomized participants, whether or not they received the assigned study drug.|||percentage of participants||95% Confidence Interval|Number
2625609|NCT01910389|Secondary|Heart Failure Hospitalization||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.||||||
2604174|NCT02123134|Primary|Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)|The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).|Baseline and up to Week 32 (12 weeks after last treatment)|ITT population included all randomized participants, whether or not they received the assigned study drug.|||percentage of participants||95% Confidence Interval|Number
2604175|NCT02123134|Primary|Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments|"The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).~The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst)."|Baseline and up to Week 32 (12 weeks after last treatment)|ITT population included all randomized participants, whether or not they received the assigned study drug.|||percentage of participants||95% Confidence Interval|Number
2604176|NCT02123134|Primary|Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments|"The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).~The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst)."|Baseline and up to Week 32 (12 weeks after last treatment)|Intent-to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug.|||percentage of participants||95% Confidence Interval|Number
2604177|NCT02123017|Secondary|Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant|Tolerability assessed by a patient questionnaire. Overall tolerability as given by Visual Analog Scale (VAS): 100 represents maximally tolerable; 0 represents minimally tolerable|1 day post last consumption||||units on a VAS scale||Standard Deviation|Mean
2604178|NCT02123017|Secondary|Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity|Safety determined by the severity of treatment emergent adverse events.|1 day post last consumption||||Percentage of subjects|||Number
2604179|NCT02123017|Secondary|Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence|Safety determined by the incidence of treatment emergent adverse events.|1 day post last consumption||||% of patients with adverse events|||Number
2604180|NCT02123017|Primary|Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy.|Efficacy assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Preparation Scale (BBPS). 9 is the maximum score, representing an fully cleansed colon; 0 is the minimal score, representing a colon with no cleaning.|10-14 hours post last consumption||||units on a scale||Standard Deviation|Mean
2604181|NCT02122952|Other Pre-specified|Number of Participants With Assessed Improvement in Motor Function|Improvement in motor function was determined by achievement of developmental milestones, specifically achievement of ability to sit unassisted for at least 30 seconds, determined by physical therapist and confirmed by an independent central video reviewer. Achievement of functional independent sitting was defined as the ability to maintain a sitting position independently for at least 30 seconds as confirmed per video evaluation by an expert central reviewer based on videos taken either at scheduled visits or provided by the parent/legal guardian.|24 months post-dose|full analysis set- all treated patients|||Participants|||Count of Participants
2604182|NCT02122952|Secondary|Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND)|CHOP-INTEND scores at baseline and 24 months post-dose. Scores = 0-64, where 64 is the maximum possible score. A higher score is indicative of higher/better motor function.|Baseline and 24 months post-dose|Includes all treated participants with non-missing data. For a major, systemic, and externally imposed limitation of movement that prevented accurate assessment of multiple items, the total score was regarded as missing. Also, CHOP-INTEND assessments were discontinued once participants achieved higher functioning status (2 consecutive scores ≥62).|||score on a scale||Standard Deviation|Mean
2604183|NCT02122952|Secondary|Number of Participants Who Experienced (a) Requirement of ≥16-hour Respiratory Assistance Per Day Continuously for ≥2 Weeks in the Absence of an Acute Reversible Illness, Excluding Perioperative Ventilation, or (b) Death|Respiratory assistance included non-invasive ventilatory support.|24 months post-dose||||Participants|||Count of Participants
2604184|NCT02122952|Primary|Number of Participants That Experienced One Grade III or Higher Unanticipated, Treatment-related Toxicity That Presents With Clinical Symptoms and Requires Medical Treatment||2 years||||Participants|||Count of Participants
2604185|NCT02122887|Secondary|Changes in Empathy as a Function of Perspective Taking|"Perspective-taking (PT), addressed the degree to which adolescents thought justice was solely on their side compared to the ability to see some justice on both sides. Participants received binary score for PT and were divided to high vs low PT groups accordingly.~We compared participants' behavioral empathy levels. Interactions were coded with the Coding Interactive Behavior (CIB) manual (Feldman, 1998), adolescent version. This version of the CIB is composed of 32 codes rated on a scale of 1 to 5, as higher score means a better outcome. Behavioral Empathy is the average of the following CIB codes: expressing empathy, acknowledging other's communication, elaborating other's topics and ideas, maintaining positive affect, maintaining visual, and give-and-receive reciprocity"|trail 2- 3 months after trail 1|All participants|||units on a scale||Standard Deviation|Mean
2604196|NCT02122796|Secondary|Change in Pain Post Intervention|Change in pain on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no pain and 10 equals most severe pain. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Pain Day 1 - Pre-Pain Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.|Participants will be followed on post operations day 1 and 2 of their hospital stay||||units on a scale||Standard Deviation|Mean
2604186|NCT02122887|Secondary|Changes in Tension as a Function of Perspective-taking and Group|"Perspective-taking (PT), addressed the degree to which adolescents thought justice was solely on their side compared to the ability to see some justice on both sides. Participants received binary score for PT and were divided to high vs low PT groups accordingly.~We compared participants' tension levels, according to level of PT and group (intervention or control). Interactions were coded with the Coding Interactive Behavior (CIB) manual (Feldman, 1998), adolescent version. This version of the CIB is composed of 32 codes rated on a scale of 1 to 5, as higher score means a better outcome. Dyadic Tension is the averaged codes; displaying a tense, anxious, and uneasy behavior, fear, and constriction of communicative output and social behavior."|trail 2- 3 months after trail1|All participants|||units on a scale||Standard Deviation|Mean
2604187|NCT02122887|Secondary|Changes in PT (Perspective-taking) After Intervention|Participants were interviewed individually on their attitudes towards the Israeli-Palestinian conflict. Perspective-taking (PT), addressed the degree to which adolescents thought justice was solely on their side and the other side is totally wrong, aggressive, and vicious compared to the ability to see some justice on both sides. Participants received binary score for PT.|trail 2- 3 months after trail 1|All participants|||Participants|||Count of Participants
2604188|NCT02122887|Secondary|Hormonal Assays-Oxytocin|Three saliva samples were collected using Salivettes® at baseline, following interaction, and ten minutes after end and averaged. All samples were then stored at −20°C. Salivette were treated as following: centrifuged twice, at 4°C at 1500 x g for 30 minutes, aliquoted and lyophilized over few days- to concentrate by 4 times. The dry samples were reconstructed in the assay buffer immediately before analysis using an oxytocin enzyme immunoassay commercial kit (ENZO, NY). The assay preformed according the kit's instruction. The concentration of oxytocin was calculated using MatLab-7|trail 2- 3 months after trail1|Some participants didn't have a measure due to insufficient saliva|||picogram/ml||Standard Deviation|Mean
2604189|NCT02122887|Secondary|Behavioral Assessment of Dialogue|"interactions were coded with the Coding Interactive Behavior (CIB) manual (Feldman, 1998), adolescent version. This version of the CIB is composed of 32 codes rated on a scale of 1 to 5, as higher score mean a better outcome. The Two following constructs were used: A personal measure of Behavioral Empathy - an average of the following CIB codes: expressing empathy, acknowledging other's communication, elaborating other's topics and ideas, maintaining positive affect, maintaining visual, and give-and-receive reciprocity and Dyadic Tension - averaged codes; displaying a tense, anxious, and uneasy behavior, fear, and constriction of communicative output and social behavior."|trail 2- 3 months after trail 1|Control group had few missing values due to problems in the interaction videos that didn't allow data analysis|||units on a scale||Standard Deviation|Mean
2604190|NCT02122887|Primary|PT (Perspective-taking)|Participants were interviewed individually on their attitudes towards the Israeli-Palestinian conflict. Perspective-taking (PT), addressed the degree to which adolescents thought justice was solely on their side and the other side is totally wrong, aggressive, and vicious compared to the ability to see some justice on both sides. Participants received binary score for PT, as 1 is some ability to see justice on the other side, and 0 is seeing justice only in own side.|trail 1-baseline|All participants|||Participants|||Count of Participants
2604191|NCT02122887|Primary|Hormonal Assays- Oxytocin|Three saliva samples were collected using Salivettes® at baseline, following interaction, and ten minutes after end and averaged. All samples were then stored at −20°C. Salivette were treated as following: centrifuged twice, at 4°C at 1500 x g for 30 minutes, aliquoted and lyophilized over few days- to concentrate by 4 times. The dry samples were reconstructed in the assay buffer immediately before analysis using an oxytocin enzyme immunoassay commercial kit (ENZO, NY). The assay preformed according the kit's instruction. The concentration of oxytocin was calculated using MatLab-7|trail 1- baseline|Some participants didn't have a measure due to insufficient saliva|||picogram/ml||Standard Deviation|Mean
2604192|NCT02122887|Primary|Behavioral Assessment of Dialogue|"Interactions were coded with the Coding Interactive Behavior (CIB) manual (Feldman, 1998), adolescent version. This version of the CIB is composed of 32 codes rated on a scale of 1 to 5, as higher score mean a better outcome. The Two following constructs were used: A personal measure of Behavioral Empathy - an average of the following CIB codes: expressing empathy, acknowledging other's communication, elaborating other's topics and ideas, maintaining positive affect, maintaining visual, and give-and-receive reciprocity and Dyadic Tension - averaged codes; displaying a tense, anxious, and uneasy behavior, fear, and constriction of communicative output and social behavior."|trail 1-baseline|All participants|||units on a scale||Standard Deviation|Mean
2604193|NCT02122796|Secondary|Change in Ability to Cope Post Intervention|Change in ability to cope on a single question 11-point Numeric Rating Scale (NRS) where 0 equals absence of an ability to cope and 10 equals complete ability to cope. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Coping Day 1 - Pre-Coping Day 1). . A higher score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.|Participants will be followed on post operations day 1 and 2 of their hospital stay||||units on a scale||Standard Deviation|Mean
2604194|NCT02122796|Secondary|Change in Nausea Post Intervention|Change in nausea on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no nausea and 10 equals most severe nausea. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Nausea Day 1 - Pre-Nausea Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.|Participants will be followed on post operations day 1 and 2 of their hospital stay||||units on a scale||Standard Deviation|Mean
2604195|NCT02122796|Secondary|Change in Anxiety Post Intervention|Change in anxiety on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no anxiety and 10 equals most severe anxiety. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Anxiety Day 1 - Pre-Anxiety Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2.|Participants will be followed on post operations day 1 and 2 of their hospital stay||||units on a scale||Standard Deviation|Mean
2604245|NCT02122146|Secondary|Maximum Observed Plasma Concentration (Cmax) for Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]|Cmax of unconjugated payload PF-06380101 was observed directly from data|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
2604197|NCT02122796|Primary|Number of Patients Eligible Compared to the Number Approached and Enrolled|Feasibility will be measured by the number of patients eligible for enrollment, the number approached, the number consented, and the final sample with completed data. The study population will be described in terms of demographics and background characteristics collected on the enrollment questionnaire.|One year|A total of 252 women were scheduled to receive a unilateral or bilateral mastectomy during the study period. Of those, 61 were eligible for study participation, and there were 30 women who provided consent and were randomized.|||Participants|||Count of Participants
2604198|NCT02122770|Secondary|Part B: Duration of Response|The duration of response was defined in participants with disease response (CR or PR) as the time between the first documentation of response and progressive disease (PD). Responders without PD will be censored at the last clinical assessment of response. CR was defined as complete disappearance of all target lesions. All pathological lymph nodes, both target and non-target, must decrease to normal (short axis <10 mm). PR was defined as at least 30% decrease under baseline of the sum of diameters of all target lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Time from the date of first documentation of a response and PD (approximately up Cycle 29)|The response-evaluable population included all participants who received at least 1 dose of study drug in Part B, had measurable disease as entry criteria for Part B, and had at least 1 postbaseline disease assessment. The response-evaluable population where data at specified time points were available.|||months||Standard Deviation|Mean
2604199|NCT02122770|Secondary|Part B: Percentage of Participants With Objective Response|Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as complete disappearance of all target lesions. All pathological lymph nodes, both target and non-target, must decrease to normal (short axis less than [<]10 millimeter [mm]). PR was defined as at least 30% decrease under baseline of the sum of diameters of all target lesions.|Baseline up to symptomatic deterioration, progressive disease (PD), treatment discontinuation, or until the study is stopped (approximately Cycle 29)|The response-evaluable population included all participants who received at least 1 dose of study drug in Part B, had measurable disease as entry criteria for Part B, and had at least 1 postbaseline disease assessment. The response-evaluable population where data at specified time points were available.|||percentage of participants||95% Confidence Interval|Number
2604200|NCT02122770|Secondary|Number of Participants With Clinically Significant Change From Baseline in Body Weight Measurements||Part A: Baseline up to Day 40; Part B: Baseline up to approximately Cycle 29|The safety population for Part A included all enrolled participants who received at least 1 dose of MLN4924 during Part A and safety population for Part B included all participants who continued to Part B and received at least 1 dose of study drugs during Part B.|||participants|||Number
2604201|NCT02122770|Secondary|Number of Participants With TEAEs Related to Clinically Significant Vital Sign Findings||Part A: Baseline up to Day 40; Part B: Baseline up to approximately Cycle 29 Day 35|The safety population for Part A included all enrolled participants who received at least 1 dose of MLN4924 during Part A and safety population for Part B included all participants who continued to Part B and received at least 1 dose of study drugs during Part B.|||Participants|||Count of Participants
2604202|NCT02122770|Secondary|Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings||Part A: Baseline up to Day 40; Part B: Baseline up to approximately Cycle 29 Day 35|The safety population for Part A included all enrolled participants who received at least 1 dose of MLN4924 during Part A and safety population for Part B included all participants who continued to Part B and received at least 1 dose of study drugs during Part B.|||Participants|||Count of Participants
2604203|NCT02122770|Secondary|Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)||Baseline up to 30 days after the last dose of study drug (Day 40 for Part A; approximately Cycle 29 for Part B)|The safety population for Part A included all enrolled participants who received at least 1 dose of MLN4924 during Part A and safety population for Part B included all participants who continued to Part B and received at least 1 dose of study drugs during Part B.|||Participants|||Count of Participants
2604204|NCT02122770|Secondary|Part A: Blood to Plasma (B/P) Concentration Ratio for MLN4924||Day 1 up to 24 hours post infusion|PK population:enrolled participants who received all protocol-specified dose regimens within each period in Part A,did not receive any excluded medications throughout completion of PK sampling, had sufficient MLN4924 plasma concentration-time data to estimate PK parameters. PK analysis population where data at specified time points were available.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2604205|NCT02122770|Secondary|Part A: Terminal Phase Elimination Half-life (T1/2) for MLN4924||Days 1 and 8: predose and at multiple time-points (up to 72 hours) postdose for Part A|PK population:enrolled participants who received all protocol-specified dose regimens within each period in Part A,did not receive any excluded medications throughout completion of PK sampling, had sufficient MLN4924 plasma concentration-time data to estimate PK parameters. PK analysis population where data at specified time points were available.|||hour||Geometric Coefficient of Variation|Geometric Mean
2604206|NCT02122770|Secondary|Part A: Volume of Distribution (Vz) for MLN4924||Days 1 and 8: predose and at multiple time-points (up to 72 hours) postdose for Part A|PK population:enrolled participants who received all protocol-specified dose regimens within each period in Part A,did not receive any excluded medications throughout completion of PK sampling, had sufficient MLN4924 plasma concentration-time data to estimate PK parameters. PK analysis population where data at specified time points were available.|||Liter (L)||Geometric Coefficient of Variation|Geometric Mean
2604207|NCT02122770|Secondary|Part A Tmax: Time to Reach the Cmax for MLN4924||Days 1 and 8: predose and at multiple time-points (up to 72 hours) postdose for Part A|PK population:enrolled participants who received all protocol-specified dose regimens within each period in Part A,did not receive any excluded medications throughout completion of PK sampling, had sufficient MLN4924 plasma concentration-time data to estimate PK parameters. PK analysis population where data at specified time points were available.|||hour||Full Range|Median
2604257|NCT02121912|Secondary|Sleep Technicians Recommendation to Use Mask|Sleep Technicians reported on whether they would recommend the mask to other professionals. Ratings were out of 1-10 and a higher score indicates a higher likelihood of recommending the mask.|1 night in the lab||||units on a scale||Standard Deviation|Mean
2604208|NCT02122770|Secondary|Part A: Plasma Clearance (CLp) for MLN4924||Days 1 and 8: predose and at multiple time-points (up to 72 hours) postdose for Part A|PK population:enrolled participants who received all protocol-specified dose regimens within each period in Part A,did not receive any excluded medications throughout completion of PK sampling, had sufficient MLN4924 plasma concentration-time data to estimate PK parameters. PK analysis population where data at specified time points were available.|||liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2604209|NCT02122770|Primary|Part A AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MLN4924 and MLN4924 + Itraconazole||Day 1 (MLN4924) and Day 8 (MLN4924 + Itraconazole): pre-dose and at multiple time points (up to 72 hours) post-dose|PK population:enrolled participants who received all protocol-specified dose regimens within each period in Part A,did not receive any excluded medications throughout completion of PK sampling, had sufficient MLN4924 plasma concentration-time data to estimate PK parameters. PK analysis population where data at specified time points were available.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2604210|NCT02122770|Primary|Part A AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MLN4924 and MLN4924 + Itraconazole||Day 1 (MLN4924) and Day 8 (MLN4924 + Itraconazole): pre-dose and at multiple time points (up to 72 hours) post-dose|PK population:enrolled participants who received all protocol-specified dose regimens within each period in Part A,did not receive any excluded medications throughout completion of PK sampling, had sufficient MLN4924 plasma concentration-time data to estimate PK parameters. PK analysis population where data at specified time points were available.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2604211|NCT02122770|Primary|Part A Cmax: Maximum Observed Plasma Concentration for MLN4924 and MLN4924 + Itraconazole||Day 1 (MLN4924) and Day 8 (MLN4924 + Itraconazole): pre-dose and at multiple time points (up to 72 hours) post-dose|The PK evaluable population included all enrolled participants who received all protocol-specified dose regimens within each period during Part A, did not received any excluded medications throughout the completion of PK sampling, and had sufficient MLN4924 plasma concentration-time data to estimate PK parameters.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2604212|NCT02122770|Primary|Part A AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MLN4924 and MLN4924 + Fluconazole||Day 1 (MLN4924) and Day 8 (MLN4924 + Fluconazole): pre-dose and at multiple time points (up to 72 hours) post-dose|The PK evaluable population included all enrolled participants who received all protocol-specified dose regimens within each period during Part A, did not received any excluded medications throughout the completion of PK sampling, and had sufficient MLN4924 plasma concentration-time data to estimate PK parameters.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2604213|NCT02122770|Primary|Part A AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MLN4924 and MLN4924 + Fluconazole||Day 1 (MLN4924) and Day 8 (MLN4924 + Fluconazole): pre-dose and at multiple time points (up to 72 hours) post-dose|The PK evaluable population included all enrolled participants who received all protocol-specified dose regimens within each period during Part A, did not received any excluded medications throughout the completion of PK sampling, and had sufficient MLN4924 plasma concentration-time data to estimate PK parameters.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2604214|NCT02122770|Primary|Part A Cmax: Maximum Observed Plasma Concentration for MLN4924 and MLN4924 + Fluconazole||Day 1 (MLN4924) and Day 8 (MLN4924 + Fluconazole): pre-dose and at multiple time points (up to 72 hours) post-dose|The pharmacokinetic (PK) evaluable population included all enrolled participants who received all protocol-specified dose regimens within each period during Part A, did not received any excluded medications throughout the completion of PK sampling, and had sufficient MLN4924 plasma concentration-time data to estimate PK parameters.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2604215|NCT02122549|Primary|Percentage of Time Rhythm Monitoring by the HWD1000 is Compromised Due to ECG Noise.|The amount of time that the HWD1000 is unable to monitor the subject's rhythm status is the primary safety measure. The specific goals are that average monitoring will be inhibited by noise no greater than 2% of the time worn (at least 24 hours) and monitoring using single lead analysis will be no greater than 5% of the time worn (at least 24 hours).|24 hours or longer|Subjects who wore the HWD 1000 for a minimum of 24 hours.|||percentage of time worn||Standard Deviation|Mean
2604216|NCT02122471|Secondary|Change From Baseline in Average Weekly Straining Score Over the 12-week Treatment Period, Mean Replacement Approach|The change from baseline in the straining score over the 12-week Treatment Period was analyzed. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly average straining score was derived from the straining scores reported during the Treatment Period in the Daily Symptom Diary. The severity of straining during bowel movements was assessed on a 5-point Likert scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.|Baseline and 12 weeks|A total of 1288 patients included in ITT-E population for secondary outcome which consisted of the randomized subjects (1410) excluding 95 duplicate subjects as described in the Participate Flow and 27 subjects eliminated from two OAI sites.|||score on a scale||Standard Deviation|Mean
2604217|NCT02122471|Secondary|Change From Baseline in Average Weekly SBM Stool Consistency Over the 12-week Treatment Period, Mean Replacement Approach|"The change from baseline in the stool consistency score (i.e. BSFS) over the 12-week Treatment Period was analyzed. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly mean BSFS score per patient was derived from the BSFS entries reported during the Treatment Period in the Daily Symptom Diary.~The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale [BSFS] from 1 to 7.~= separate hard lumps like nuts (difficult to pass)~= sausage shaped but lumpy~= like a sausage but with cracks on its surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges (passed easily)~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces (entirely liquid)"|Baseline and 12 weeks|A total of 1288 patients included in ITT-E population for secondary outcome which consisted of the randomized subjects (1410) excluding 95 duplicate subjects as described in the Participate Flow and 27 subjects eliminated from two OAI sites.|||score on a scale||Standard Deviation|Mean
2604218|NCT02122471|Secondary|Change From Baseline in SBMs (SBMs/Week) Over the 12-week Treatment Period, Mean Replacement Approach|The change from baseline in the number of Spontaneous Bowel Movement (SBM) over the 12-week Treatment Period was analyzed. Baseline was the mean number of SBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly SBM totals were derived from the daily diary entries reported during the Treatment Period.|Baseline and 12 weeks|A total of 1288 patients included in ITT-E population for secondary outcome which consisted of the randomized subjects (1410) excluding 95 duplicate subjects as described in the Participate Flow and 27 subjects eliminated from two OAI sites.|||SBMs per week||Standard Deviation|Mean
2604219|NCT02122471|Secondary|Change From Baseline in CSBMs (CSBMs/Week) Over the 12-week Treatment Period , Mean Replacement Approach|The change from baseline in the number of Complete Spontaneous Bowel Movements (CSBMs) over the 12-week Treatment Period was analyzed. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. A CSBM was a bowel movement that occurred in the absence of laxative use within 24 hours and was associated with the feeling of complete evacuation.|Baseline and 12 weeks|A total of 1288 patients included in ITT-E population for secondary outcome which consisted of the randomized subjects (1410) excluding 95 duplicate subjects as described in the Participate Flow and 27 subjects eliminated from two OAI sites.|||CSBMs per week||Standard Error|Least Squares Mean
2604220|NCT02122471|Primary|Number of Durable Overall CSBM Responders, Mean Replacement Approach|The primary efficacy endpoint was measured by the number of durable overall CSBM responders over the 12-week Treatment Period. A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks. A CSBM weekly responder was defined as a patient who has ≥ 3 Complete Spontaneous Bowel Movements (CSBMs) per week and an increase from baseline of ≥1 CSBM for that week. A CSBM was a bowel movement that occurred in the absence of laxative use within 24 hours and was associated with the feeling of complete evacuation.|12-Week Treatment Period|"The modified ITT population (1310 subjects) for primary outcome was ITT population minus 27 subjects eliminated from two OAI sites. The ITT population (1337) as described in the Participate Flow consisted of the randomized subjects (1410) excluding 73 non-index subjects. Index subjects were duplicate subjects appeared once in the ITT population."|||Participants|||Count of Participants
2604221|NCT02122445|Secondary|Perceived Exertion|The amount of perceived exertion was reported for each of the 4 exercises (ClamsR, Sidelying, StandingAB, ForwardBend) at 3 time points (Baseline[T1], Immediate post[T2], 24hrs[T3]), by 20 subjects, totaling 240 data points. This was measured using the TheraBand(R) Resistance Intensity Scale for Exercise (RISE Scale). Participants were asked to rate their perceived exertion on a scale of 0 to 10, 0 being no resistance and 10 being maximum resistance. The results of the 20 subjects were averaged for each exercise at each time point.|Perceived Exertion||||units on a scale, from 0 to 10||Full Range|Mean
2604222|NCT02122445|Primary|Percent of Maximal Voluntary Isometric Contraction (%MVIC)|3 muscles during 4 exercises (ClamsR, Sidelying, StandingAB, ForwardBend) at 3 time points (Baseline[T1], Immediate post[T2], 24hrs[T3]), were analyzed in 20 subjects, totaling 720 data points. Maximal voluntary isometric contraction(MVIC) was assessed using the standard manual muscle testing positions. For each subject, the EMG signals of the muscles during the exercises were smoothed, rectified and analyzed using a root-mean-square algorithm and the greatest activation of each muscle was used. After the peak activation(PA) for each muscle was determined, it was compared to the MVIC of the reference exercise for the respective muscle group, and expressed as a percent of MVIC (%MVIC). In some cases the %MVIC is greater than 100% because the MVIC was assessed during a manual muscle test position. During an exercise some muscles generated greater PA and therefore when calculated the %MVIC was greater than 100%. Due to the amount of data, we have provided the Gmax %MVIC results.|% Maximal Voluntary Isometric Contracion (%MVIC)||||% of Max Voluntary Isometric Contraction||Full Range|Mean
2604223|NCT02122406|Primary|Hospital Anxiety and Depression Scale (HADS)|Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.|1 day of enrollement||||participants|||Number
2604224|NCT02122341|Other Pre-specified|Duration of Lithotripsy Procedure|Duration of Lithotripsy Procedure|during surgery||||minutes||Full Range|Mean
2604225|NCT02122341|Other Pre-specified|Time for BackStop Injection|Time required to deliver BackStop beginning with insertion of BackStop catheter and ending with its removal subsequent to the delivery of BackStop|Minutes during Surgery|The control group did not receive BackStop injection|||minutes||Full Range|Mean
2604226|NCT02122341|Other Pre-specified|Need for Secondary Procedures|Need for secondary procedures of patients who had stone migration|Up to 3 months||||Participants|||Count of Participants
2604227|NCT02122341|Secondary|Stone-free Rate|Presence or absence of residual stone fragments at 2 month follow up after lithotripsy|2 months|Number of patients analyzed is inconsistent with numbers provided in participant flow module due to patients lost to follow up|||Participants|||Count of Participants
2604228|NCT02122341|Primary|Rate of Prevention of Retrograde Stone or Stone Fragment Migration|Prevention of retrograde stone migration (Yes/No)|At the time of surgery||||Participants|||Count of Participants
2604229|NCT02122146|Secondary|Accumulation Ratio (Rac) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]|Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
2604230|NCT02122146|Secondary|Accumulation Ratio (Rac) of Total Antibody (PF-06479118) [Part 1 ,2 & 3]|Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
2604231|NCT02122146|Secondary|Accumulation Ratio (Rac) of PF-06664178 [Part 1 ,2 & 3]|Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
2604232|NCT02122146|Secondary|Trop-2 Expression Levels on Archived Tissue [Part 2 & 3]|Number of participents meeting the following criterion for Trop-2 expression assessment : low expression, medium expression and high expression|Day 1|No participant was analyzed due to study termination||||||
2604233|NCT02122146|Secondary|Terminal Elimination Half-Life (t1/2) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
2604234|NCT02122146|Secondary|Terminal Elimination Half-Life (t1/2) of Total Antibody (PF-06479118)[Part 1 ,2 & 3]|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
2604235|NCT02122146|Secondary|Terminal Elimination Half-Life (t1/2) of PF-06664178 [Part 1 ,2 & 3]|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
2604236|NCT02122146|Secondary|Volume of Distribution (Vss) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
2604237|NCT02122146|Secondary|Volume of Distribution (Vss) of Total Antibody (PF-06479118) [Part 1 ,2 & 3]|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
2604238|NCT02122146|Secondary|Volume of Distribution (Vss) of PF-06664178 [Part 1 ,2 & 3]|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
2604239|NCT02122146|Secondary|Systemic Clearance (CL) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3]|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
2604240|NCT02122146|Secondary|Systemic Clearance (CL) of Total Antibody (PF-06479118) [Part 1 ,2 & 3]|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
2604241|NCT02122146|Secondary|Systemic Clearance (CL) of PF-06664178 [Part 1 ,2 & 3]|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
2604242|NCT02122146|Secondary|Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Unconjugated Payload(PF-06380101) [Part 1 ,2 & 3]|AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
2604243|NCT02122146|Secondary|Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Total Antibody(PF-06479118) [Part 1 ,2 & 3]|AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval.|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
2604244|NCT02122146|Secondary|Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of PF-06664178 [Part 1 ,2 & 3]|AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
2604246|NCT02122146|Secondary|Maximum Observed Plasma Concentration (Cmax) for Total Antibody (PF-06479118) [Part 1 ,2 & 3]|Cmax of total antibody PF-06479118 was observed directly from data|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
2604247|NCT02122146|Secondary|Maximum Observed Plasma Concentration (Cmax) for PF-06664178 [Part 1 ,2 & 3]|Cmax of PF-06664178 was observed directly from data|0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment|Data were not collected during Part 1, and no participant was analyzed in Part 2 and 3 due to study termination||||||
2604248|NCT02122146|Secondary|Overall Number of Participants With Objective Tumor Response [Part 2 & 3]|Objective tumor response, as assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 by calculating the Overall Response Rate (ORR), and Prolonged Stable Disease (SD).No Progression Free Survival (PFS) was completed. The criterion is as follow: Objective Progression(PD), Stable (SD), symptomatic deterioration(Sym), and Indeterminate (In)|Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months|No participant was analyzed due to study termination||||||
2604249|NCT02122146|Secondary|Overall Number of Participants With Objective Tumor Response[Part 1]|Objective tumor response, was assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 by calculating the Overall Response Rate, and Prolonged Stable Disease. The criterion is defined as: Objective Progression(PD):20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5mm; Stable (SD): All target lesions must be assessed. Stable can follow PR only in the rare case that the sum increases by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds; symptomatic deterioration(Sym):Participants with a global deterioration of health status requiring discontinuation of treatment without objective evidence of disease progression at that time; Indeterminate (In):Progression has not been determined and one, or more non-target sites were not assessed, or assessment methods were inconsistent with those used at baseline.|Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months|Of all enrolled 31 patients who were treated, 1 participant from the 0.60mg/kg cohort and 1 participant from the 4.20mg/kg cohort did not have post-dose tumor evaluations for they were discontinued form study prior to having disease assessment .|||participants|||Number
2604250|NCT02122146|Secondary|Overall Incidence of Anti-PF-06664178-Antibodies [Part 2 & 3]|Number of participants with the presence of anti-PF-06664178 antibodies|Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment|No participant was analyzed due to study termination||||||
2604251|NCT02122146|Secondary|Overall Incidence of Anti-PF-06664178-Antibodies[Part 1]|Number of participants with the presence of anti-PF-06664178 antibodies|Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment|All enrolled participants who started treatment|||participants|||Number
2604252|NCT02122146|Secondary|Number of Participants With Laboratory Abnormalities[Part 1]|Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test.|Screening; on Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued)|All enrolled participants who started treatment.|||participants|||Number
2604253|NCT02122146|Secondary|Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs ) [Part 1]|An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug.|From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(At least 28 days and no more than 35 days after discontinuation of treatment)|All enrolled participants who started treatment|||participants|||Number
2604254|NCT02122146|Primary|Number of Participants With Laboratory Abnormalities [Part 2 & 3]|Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test.|On Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued)|No participant was analyzed due to study termination||||||
2604255|NCT02122146|Primary|Number of Patients With All-Causality Treatment-Emergent Adverse Events(TEAEs) [Part 2 & 3]|An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug.|Day 1 up to Day 21|No participant was analyzed due to study termination||||||
2604256|NCT02122146|Primary|First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)|Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.|Day 1 up to Day 21|All enrolled participants who started treatment. One of participants that experienced DLTs in PF-06664178 4.80mg/kg group was a late DLT that occurred at the beginning of Cycle 2 and was classified as a late DLT.|||participants|||Number
2604258|NCT02121912|Secondary|Mask Leak|The Sleep Technologist will record mask leak every 10minutes, over an 8 hour period during the sleep study.|Every 10min, for up to 8 hours||||liters/minute||Standard Error|Mean
2604259|NCT02121912|Primary|Subjective Questionnaire of Mask Experience|Sleep technicians reported on their experience using the mask after 1 night in the lab on a scale from 1 to 10 with a higher score indicating a better experience|1 night in the lab|While not all participants completed the full study, participants who provided acceptable data were used in the analysis. The number of participants analyzed may be different from the number who completed. Due to the nature of this study, participant completion did not have a direct effect on this outcome measure.|||units on a scale||Standard Deviation|Mean
2604260|NCT02121860|Primary|Cmax|Maximum concentration (Cmax)|48 Hours||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2604261|NCT02121860|Secondary|Levels of Caspase 3/7 RLU|Concentration of Caspase 3/7 Relative Light Units|predose, 0.5, 1,2,3,4,5,8,12,24, and 48 hours post dose||||RLU||Inter-Quartile Range|Median
2604262|NCT02121860|Secondary|Levels of cCK18/M30|Caspase-cleaved cytokeratin levels (cCK18M30)|predose, 0.5, 1,2,3,4,5,8,12,24, and 48 hours post dose||||U/L||Inter-Quartile Range|Median
2604263|NCT02121860|Primary|AUC|Area under the plasma concentration curve (AUC) to 12 hours post-dose (AUC0-12); AUC to the last observed plasma concentration (AUClast);|48 Hours|The analyzed sample size was 36 subjects: 12 subjects with mild, and 8 subjects each with moderate and severe hepatic impairment, and with normal hepatic function.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2604264|NCT02121847|Secondary|Change From Baseline in Conjunctival Redness in the Worse Eye|Conjunctival redness is scored in the worse eye on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Scores on a Scale||Standard Deviation|Mean
2604265|NCT02121847|Secondary|Change From Baseline in the Interblink Interval in the Worse Eye|The interblink interval measures the time (seconds) between blinks in the worse eye. A positive number change from baseline indicates a worsening (more frequent blinks) and a negative number change from baseline (less frequent blinks) indicates an improvement.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Seconds||Standard Deviation|Mean
2604266|NCT02121847|Secondary|Change From Baseline in Tear Film Break-up Time in the Worse Eye|TFBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement and a negative number change from baseline indicates a worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Seconds||Standard Deviation|Mean
2604267|NCT02121847|Secondary|Change From Baseline in Ocular Discomfort on a 4-point Scale|Ocular discomfort is assessed on a 4-point scale where 0=no discomfort and 3=most discomfort. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.|Baseline, Month 6||||Scores on a Scale||Standard Deviation|Mean
2604268|NCT02121847|Secondary|Change From Baseline in OSDI|The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Scores on a Scale||Standard Deviation|Mean
2604269|NCT02121847|Primary|Change From Baseline in Font Size|The minimum font (letter) size read correctly is assessed. Smaller font size indicates better ability. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Size||Standard Deviation|Mean
2604270|NCT02121847|Primary|Change From Baseline in Words Read Incorrectly|The numbers of words read incorrectly are counted in 2 minutes. A positive change from baseline indicates a worsening, and a negative change from baseline indicates an improvement.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Words||Standard Deviation|Mean
2604271|NCT02121847|Primary|Change From Baseline in Reading Rate|Reading speed is assessed as the number of words read correctly in 2 minutes.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Words/Minute||Standard Deviation|Mean
2604272|NCT02121847|Primary|Change From Baseline in Watching TV on the OSDI|The OSDI consists of 12 questions measuring the presence of ocular symptoms. The watching TV question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The watching TV score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure|||Scores on a Scale||Standard Deviation|Mean
2604273|NCT02121847|Primary|Change From Baseline in Working With a Computer or Bank Machine on the OSDI|The OSDI consists of 12 questions measuring the presence of ocular symptoms. The working with a computer or bank machine question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The working with a computer or bank machine score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure|||Scores on a Scale||Standard Deviation|Mean
2604274|NCT02121847|Primary|Change From Baseline in Driving at Night on the OSDI|The OSDI consists of 12 questions measuring the presence of ocular symptoms. The driving at night question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The driving at night score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug and who have data for this outcome measure|||Scores on a Scale||Standard Deviation|Mean
2604275|NCT02121847|Primary|Change From Baseline in Reading on the Ocular Surface Disease Index (OSDI)|The OSDI consists of 12 questions measuring the presence of ocular symptoms. The reading question is assessed using a 5-point scale (0=none of the time; 4=all of the time). The reading score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI reading scores are associated with greater severity. A negative number change from baseline indicates improvement and a positive number change from baseline indicates worsening.|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Scores on a Scale||Standard Deviation|Mean
2604276|NCT02121847|Primary|Change From Baseline in Total Conjunctival Staining Score With Lissamine Green in the Worse Eye|Total conjunctival staining with lissamine is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Scores on a Scale||Standard Deviation|Mean
2604277|NCT02121847|Primary|Change From Baseline in Total Corneal Staining Score With Lissamine Green in the Worse Eye|Total corneal staining with lissamine green is measured in the worse eye utilizing the Ora CalibraTM Corneal Lissamine Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Scores on a Scale||Standard Deviation|Mean
2604278|NCT02121847|Primary|Change From Baseline in Total Conjunctival Staining Score With Fluorescein in the Worse Eye|Total conjunctival staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Conjunctiva Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 2 regions of the conjunctiva, resulting in a maximum possible score of 8 (severe staining score of 4 in both regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Scores on a Scale||Standard Deviation|Mean
2604279|NCT02121847|Primary|Change From Baseline in Total Corneal Staining Score With Fluorescein in the Worse Eye|Total corneal staining with fluorescein is measured in the worse eye utilizing the Ora CalibraTM Corneal Flourescein Staining Scale (0 to 4 scale where 0=no staining and 4= severe staining). The sum of the total includes 3 regions of the cornea, resulting in a maximum possible score of 12 (severe staining score of 4 in all three regions). A negative change from baseline represents a decrease in staining (improvement). A positive change from baseline represents an increase in staining (worsening).|Baseline, Month 6|Intent-to-Treat: all enrolled patients who received at least one dose of the study drug|||Scores on a Scale||Standard Deviation|Mean
2604280|NCT02121834|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Multiple Doses of LY3050258||Baseline through 4 weeks: Day 1 at 4,8,12, 18, and 24 hours (hrs); Day 7 at Pre-dose, 4,8,and 12 hrs; Day 14 at Pre-dose; Days 26 and 27 at Pre-dose; Day 28 at Pre-dose, 4, 8,12,18, and 24 hrs|All participants who received at least one dose of study drug and had measurable Cmax PK concentrations after dosing.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2604281|NCT02121834|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve During One Dosing Interval at Steady State (AUC τ,ss) of Multiple Doses of LY3050258||Baseline through 4 weeks: Day 1 at 4,8,12, 18, and 24 hours (hrs); Day 7 at Pre-dose, 4,8,and 12 hrs; Day 14 at Pre-dose; Days 26 and 27 at Pre-dose; Day 28 at Pre-dose, 4, 8,12,18, and 24 hrs|All participants who received at least one dose of study drug and had measurable AUC PK concentrations after dosing.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2604282|NCT02121834|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|Clinically significant events were defined as serious and other nonserious adverse events (AE) related to study drug. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline to Study Completion (Up to 14 Weeks)|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2604283|NCT02121808|Other Pre-specified|Vital Signs|Change in vital signs before and after the pre-oxygenation phase in the 6 combinations after a 5 minutes pre-oxygenation period in the 6 combinations previously described.|At the end of a 5 minutes pre-oxygenation period|||||||
2604284|NCT02121808|Secondary|Patient's Comfort|Evaluation of the patient's comfort at the end of each intervention on an analog visual scale after a 5 minutes pre-oxygenation period in the 6 combinations previously described.|At the end of a 5 minutes pre-oxygenation period|||||||
2604285|NCT02121808|Secondary|Respiratory Mechanics|Change in respiratory mechanics (compliance, resistance, tidal volume, positive end-expiratory pressure, maximal inspiratory pressure) evaluated at the end of a 5 minutes pre-oxygenation period in the 6 combinations previously described.|At the end of a 5 minutes pre-oxygenation period|||||||
2604286|NCT02121808|Secondary|Diaphragmatic Amplitude.|Evaluation of changes in diaphragmatic amplitude and movement determined by fluoroscopy imaging after a 5 minutes pre-oxygenation period in the 6 combinations previously described.|After a 5 minutes pre-oxygenation period|||||||
2604287|NCT02121808|Primary|Functional Residual Capacity|Change of functional residual capacity (FRC), in obese patient, as a result of different pre-oxygenation positions; 1- supine, 2-beach-chair, 3- reverse Trendelenburg, in two different ventilation modes : 1- spontaneous ventilation at tidal volume, 2- non-invasive positive pressure ventilation with inspiratory assistance.|After a 5 minutes pre-oxygenation period||||ml||Standard Deviation|Mean
2604288|NCT02121795|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with on-treatment data were analyzed.|||cells/μL||Standard Deviation|Mean
2604289|NCT02121795|Secondary|Percentage Change From Baseline in Spine BMD at Week 96|Spine BMD was assessed by DXA scan.|Baseline; Week 96|Participants in the Spine DXA Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2604291|NCT02121795|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 as Defined by the FDA Snapshot Analysis|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2604292|NCT02121795|Secondary|Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the FDA Snapshot Analysis|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2604293|NCT02121795|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with on-treatment data were analyzed.|||cells/μL||Standard Deviation|Mean
2604294|NCT02121795|Secondary|Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2604295|NCT02121795|Secondary|Percentage Change From Baseline in Spine BMD at Week 48|Spine BMD was assessed by DXA scan.|Baseline; Week 48|Participants in the Spine DXA Analysis Set (participants who were randomized and received at least one dose of study drug and had nonmissing baseline spine BMD data) with available data were analyzed.|||percentage change||Standard Deviation|Mean
2604296|NCT02121795|Secondary|Percentage Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline; Week 48|Participants in the Hip DXA Analysis Set (participants who were randomized and received at least one dose of study drug and had nonmissing baseline hip BMD data) with available data were analyzed.|||percentage change||Standard Deviation|Mean
2604297|NCT02121795|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Analysis|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|The Full Analysis Set included all participants who were randomized into the study and received at least one dose of study drug.|||percentage of participants|||Number
2604298|NCT02121756|Secondary|Changes in Brachial Artery Flow-mediated Dilation (FMD)|To compare % change at tmax in brachial artery flow-mediated dilation (FMD) after 12 weeks of dipyridamole treatment to placebo|Baseline to week 12|Per protocol, participants randomized to placebo were crossed over to DP after week 12.|||percentage change at tmax||Standard Deviation|Mean
2604299|NCT02121756|Secondary|Coagulation Biomarkers: Change in the Levels of D-dimer|To compare changes in the levels of D-dimer after 12 weeks of dipyridamole treatment to placebo|Baseline to week 12|Per protocol, participants randomized to placebo were crossed over to Dipyridamole after week 12.|||mcg/ml||Inter-Quartile Range|Median
2604300|NCT02121756|Secondary|Systemic Inflammatory Biomarkers: Change in the Levels of hsCRP|To compare changes in the levels of hsCRP after 12 weeks of dipyridamole treatment to placebo|Baseline to week 12|Per protocol, participants randomized to placebo were crossed over to Dipyridamole after week 12.|||ng/dl||Inter-Quartile Range|Median
2604301|NCT02121756|Secondary|Systemic Inflammatory Biomarkers: Change in the Levels of TNFα|To compare changes in the levels of TNFα after 12 weeks of dipyridamole treatment to placebo|Baseline to week 12|Per protocol, participants randomized to placebo were crossed over to Dipyridamole after week 12.|||pg/ml||Inter-Quartile Range|Median
2604302|NCT02121756|Secondary|Systemic Inflammatory Biomarkers: Change in the Levels of sTNFαR|To compare changes in the levels of sTNFαR after 12 weeks of dipyridamole treatment to placebo|Baseline to week 12|Per protocol, participants randomized to placebo were crossed over to Dipyridamole after week 12.|||pg/ml||Inter-Quartile Range|Median
2604303|NCT02121756|Secondary|Cellular Immune Activation: Change in the Proportion of Cycling CD8+ T Cells|To assess whether Dipyridamole reduces the proportion of cycling CD8+ T cells as measured by Ki-67 expression at baseline and after treatment with Dipyridamole.|Baseline to week 12|Per protocol, participants randomized to placebo were crossed over to Dipyridamole after week 12.|||proportion of cycling CD8+ T Cells||Inter-Quartile Range|Median
2604304|NCT02121756|Secondary|Immune System Activation Assessed by the Proportion of CD4+ T Cells Co-expressing CD69 and CD25 After 12 Weeks of Dipyridamole Treatment to Placebo|To compare changes in the level of T cell immune activation as measured by the proportion of CD4+ T cells co-expressing CD69 and CD25 after 12 weeks of Dipyridamole treatment to placebo.|Baseline to week 12|Per protocol, participants randomized to placebo were crossed over to Dipyridamole after week 12.|||proportion of CD4+ T cells||Inter-Quartile Range|Median
2604305|NCT02121756|Secondary|Immune System Activation as Measured by the Proportion of CD8+ T Cells Co-expressing HLA-DR and CD38 After 12 Weeks of Dipyridamole Treatment Compared to Placebo|To compare changes in the level of T cell immune activation as measured by the proportion of CD8+ T cells co-expressing HLA-DR and CD38 after 12 weeks of Dipyridamole treatment to placebo.|Baseline to week 12|Per protocol, participants randomized to placebo were crossed over to Dipyridamole after week 12.|||proportion of CD8+ T cells||Inter-Quartile Range|Median
2604306|NCT02121756|Secondary|Immune System Activation as Measured by the Proportion of CD4+ T Cells Co-expressing HLA-DR and CD38 After 12 Weeks of Dipyridamole Treatment Compared to Placebo|To compare changes in the level of T cell immune activation as measured by the proportion of CD4+ T cells co-expressing HLA-DR and CD38 after 12 weeks of DP treatment to placebo.|Baseline to week 12|Per protocol, participants randomized to placebo were crossed over to DP after week 12.|||proportion of CD4+ T cells||Inter-Quartile Range|Median
2605207|NCT02112045|Secondary|Progression-free Survival as Measured by Number of Participants Without Disease Progression at Last Follow-up|PFS is defined as the duration from time of transplant Day 0 to time of first progression/clinical relapse, death, or the date the patient was last known to be in remission|Up to 2 years||||Participants|||Count of Participants
2604307|NCT02121756|Secondary|Immune System Activation Assessed as the Change in the Proportion of Cycling CD4+ T Cells as Measured by Ki-67 Expression at Baseline and After Treatment With Dipyridamole|To assess whether Dipyridamole reduces the proportion of cycling CD4+ T cells as measured by Ki-67 expression at baseline and after treatment with Dipyridamole.|Baseline to week 12|Per protocol, participants randomized to placebo were crossed over to DP after week 12.|||proportion of cycling CD4+ T Cells||Inter-Quartile Range|Median
2604308|NCT02121756|Secondary|Safety and Tolerability of Dipyridamole Assessed as the Number of Participants With Grade 2 or Higher Adverse Events or Treatment Discontinuations|Grade 2 or higher adverse events and treatment discontinuations|First 12 weeks of dipyridamole treatment|All enrolled participants|||Participants|||Count of Participants
2604309|NCT02121756|Secondary|Immune System Activation as Measured by the Proportion of CD8+ T Cells Co-expressing CD69 and CD25 After 12 Weeks of Dipyridamole Treatment Compared to Placebo|To compare changes in the level of T cell immune activation as measured by the proportion of CD8+ T cells co-expressing CD69 and CD25 after 12 weeks of Dipyridamole treatment to placebo.|Baseline to week 12|Per protocol, participants randomized to placebo were crossed over to DP after week 12.|||proportion of CD8+ T cells||Inter-Quartile Range|Median
2604310|NCT02121756|Primary|Systemic Inflammation Assessed as Change in IL-6 Plasma Levels From Baseline to Week 12|Change in Plasma levels of IL-6 from baseline to week 12|baseline to week 12|35 participants were included in the as-treated (AT) analysis (17 Dipyridamole, 18 placebo); 4 Dipyridamole (1 adverse event 1 protocol deviation, 2 investigator discretion) and 1 placebo (change in antiretroviral therapy) participants were excluded from the primary AT analysis.|||pg/ml||Inter-Quartile Range|Median
2604311|NCT02121756|Primary|Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD163 From Baseline to Week 12|Change in Plasma levels of sCD163 from baseline to week 12|baseline to week 12|35 participants were included in the as-treated (AT) analysis (17 Dipyridamole, 18 placebo); 4 Dipyridamole (1 adverse event 1 protocol deviation, 2 investigator discretion) and 1 placebo (change in antiretroviral therapy) participants were excluded from the primary AT analysis.|||ng/ml||Inter-Quartile Range|Median
2604312|NCT02121756|Primary|Monocyte and Macrophage Activation Assessed as Change in Plasma Levels of sCD14 From Baseline to Week 12|Change in plasma levels of sCD14 from baseline to week 12|Baseline to week 12|35 participants were included in the as-treated (AT) analysis (17 Dipyridamole, 18 placebo); 4 Dipyridamole (1 adverse event 1 protocol deviation, 2 investigator discretion) and 1 placebo (change in antiretroviral therapy) participants were excluded from the primary AT analysis.|||pg/ml||Inter-Quartile Range|Median
2604313|NCT02121535|Secondary|AUC0-∞ for Hydrochlorothiazide|AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)|3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2604314|NCT02121535|Primary|AUC0-tz for Hydrochlorothiazide|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)|3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2604315|NCT02121535|Primary|Cmax for Hydrochlorothiazide|Cmax (maximum measured concentration of the analyte in plasma)|3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h after drug administration|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2604316|NCT02121535|Primary|Cmax for Amlodipine|Cmax (maximum measured concentration of the analyte in plasma)|3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2604317|NCT02121535|Primary|AUC0-tz for Amlodipine|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)|3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2604318|NCT02121535|Secondary|AUC0-∞ for Amlodipine|AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)|3hours(h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h, 96h, 120h, 144h after drug administration|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2604319|NCT02121535|Secondary|AUC0-∞ for Telmisartan|AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)|3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2604320|NCT02121535|Primary|Cmax for Telmisartan|Cmax (maximum measured concentration of the analyte in plasma)|3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration|PKS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2604321|NCT02121535|Primary|Area Under the Concentration-time Curve of the Telmisartan in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)|3hours(h) before drug administration and 15minutes (m), 30m, 45m, 1h, 1h30m, 2h, 2h30m, 3h, 4h, 6h, 8h, 12h, 24h, 32h, 48h, 72h after drug administration|"Pharmacokinetic set (PKS):~included all subjects in the TS who had evaluable pharmacokinetic (PK) variables for both test drug and reference drugs. Subjects who had an important protocol violation (PV) for relevant PK evaluation were excluded from the PKS."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2604322|NCT02121522|Secondary|Change From Baseline in Neovascular Leakage Area as Assessed by FA on Day 29|Change from baseline in neovascular leakage area as assessed by Fluorescein angiography (FA) on day 29. Baseline is defined as the last value collected before the first trial drug intake. Data collected after start of wet age-related macular degeneration (wAMD) therapy are set to missing.|Baseline and day 29|Treated set (OC). Observed Case (OC): This method analysed only available data that were observed while patients were on treatment, ie., missing data were not imputed.|||mm²||Standard Deviation|Mean
2604323|NCT02121522|Primary|Change From Baseline in CRT as Measured by SD-OCT on Day 29|Change from baseline in central 1-mm retinal thickness (CRT) as measured by spectral domain optical coherence tomography (SD-OCT) on day 29.|Baseline (day 1) and day 29|Treated set (WOCF). Missing values are imputed by the worst observation carried forward (WOCF) measurement (including baseline).|||μm||Standard Deviation|Mean
2604324|NCT02121509|Secondary|AUC0-inf of Metformin in Plasma|"AUC0−inf(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Metformin.~The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2604325|NCT02121509|Secondary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)|"AUC0−inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Linagliptin.~The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2604326|NCT02121509|Primary|Cmax of Metformin in Plasma|Cmax (maximum measured concentration of the Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2604327|NCT02121509|Primary|Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|AUC 0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2604328|NCT02121509|Primary|Maximum Measured Concentration of Linagliptin in Plasma (Cmax)|Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1500 fast and PKS 1500 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2604329|NCT02121509|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)|AUC 0-72 (area under the concentration-time curve of the Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS1500 Fast and PKS1500 Fed, included all treated subjects in Part 1 and Part 2, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2604330|NCT02121483|Secondary|Change From Baseline in 8-point Plasma Glucose Profile Over 24 h After Study Drug Intake|"Change from baseline in 8-point plasma glucose profile over 24h after study drug intake (as defined by change from baseline in Mean Daily Glucose (MDG) calculated at Day 1).~For the changes from baseline in MDG on Day 1, adjusted means per treatment group were to be calculated based on an ANCOVA including 'treatment' as fixed effect and 'MDG at baseline' as continuous covariate.~Means presented are the adjusted means."|baseline and 24 hours|Treated Set (TS) including patients with plasma glucose profile data on both visits|||mg/dL||Standard Error|Mean
2604331|NCT02121483|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 24 h After Study Drug Intake|"Change from baseline in Fasting Plasma Glucose (FPG) at 24h after study drug intake.~For the change from baseline in FPG at 24 h postdose (in the morning of Day 2), adjusted means per treatment group were to be calculated based on an ANCOVA including 'treatment' as a fixed effect and 'FPG at baseline' as continuous covariate.~Means presented are the adjusted means."|baseline and 24 hours|Treated Set (TS) including patients with FPG data on both visits|||mg/dL||Standard Error|Mean
2604332|NCT02121483|Secondary|Change From Baseline in Urinary Glucose Excretion (UGE) Over 24 h After Study Drug Intake|"Change from baseline in Urinary Glucose Excretion (UGE) over 24 h after study drug intake.~For the changes from baseline in UGE on Day 1 (0 to 24 h postdose) , adjusted means per treatment group were to be calculated based on an ANCOVA including 'treatment' as a fixed effect and 'UGE at baseline' and 'FPG at baseline' as continuous covariates. Means presented are the adjusted means."|baseline and 24 hours|Treated Set (TS) including patients with UGE data on both visits|||g/24h||Standard Error|Mean
2604333|NCT02121483|Primary|t1/2|Terminal half-life in plasma (t1/2).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.|||hours||Geometric Coefficient of Variation|Geometric Mean
2604334|NCT02121483|Primary|Tmax|Maximum measured concentration in plasma (tmax).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.|||hours||Full Range|Median
2604335|NCT02121483|Primary|Cmax|Maximum measured concentration in plasma (Cmax).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2604336|NCT02121483|Primary|AUC0-tz|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2604337|NCT02121483|Primary|AUC0-inf|Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).|Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.|Pharmacokinetic Set (PKS): The PKS included all treated patients who provided at least 1 primary or secondary pharmacokinetic parameter for statistical assessment.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2604338|NCT02121418|Secondary|Response Rate|Rate of Complete Response or Complete Response with Incomplete Count Recovery|Up to 2 years||||participants|||Number
2604339|NCT02121418|Primary|Overall Survival of Patients Over Age 60 With Newly Diagnosed AML/High Risk MDS|Compared to historical data of a completed Southwestern Oncology Group (SWOG) trial of azacitidine and gemtuzumab ozogamicin.|At 6 months||||participants|||Number
2604340|NCT02121210|Secondary|Serum Sarilumab Concentration|Trough Concentration (Ctrough).|Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, 24 and 30|Analysis was performed on pharmacokinetic (PK) population consisted of all randomized population actually received at least one or partial dose of IMP, with at least one post-dose, non-missing serum sarilumab concentration. Number of participants analyzed=participants with serum sarilumab concentration assessment at specified time-points.|||ng/mL||Standard Deviation|Mean
2604341|NCT02121210|Primary|Percentage of Participants With Incidence of Antidrug Antibodies (ADA)|ADA to sarilumab and anti-sarilumab neutralizing antibodies in serum samples were determined using a validated electrochemiluminescence immunoassay method. Percentage of participants with positive ADA during treatment emergent adverse event (TEAE) period (time from first dose of investigational medicinal product [IMP] to last dose of IMP + 60 days) was determined. Persistent ADA Response: treatment-emergent ADA detected at 2 or more consecutive sampling time points during the TEAE period, where the first and last ADA positive samples were separated by a period of at least 16 weeks or if the last measured sample was positive. ADA samples were collected prior to IMP administration at Week 0 (baseline), Week 2, 4, 12, 24 and 30.|From Baseline to Week 30 [End of study (EOS)]|Analysis was performed on immunogenicity population included all randomized participants who received at least one dose of sarilumab with at least one post-dose, evaluable ADA sample.|||Percentage of participants|||Number
2604342|NCT02121067|Secondary|Number of Participants With Expulsion (Complete or Partial) of LNG-IUS at Six-months.|Expulsion will be defined as any of the following (1) patient report that the LNG-IUS came out, (2) ultrasound evaluation that demonstrates the LNG-IUS is not intrauterine (3) ultrasound or clinical evaluation that demonstrates the majority of the LNG-IUS is located in the cervix.|6 months postpartum|Of the 50 participants who enrolled and had an LNG-IUS placed at 2 weeks postpartum, only 43 were available at 6 months postpartum to provide data for expulsion.|||Participants|||Count of Participants
2604343|NCT02121067|Primary|Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion in the 2 Week (Day 14-20) Postpartum Period.|Was the LNG-IUS successfully placed in the study period, as determined by whether the participant had an LNG-IUS placed on the day of insertion?|Day 14-20 postpartum||||Participants|||Count of Participants
2604344|NCT02121067|Primary|Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum.|"A dichotomous, yes/no answer to the following question Would you recommend Mirena placement at two-weeks postpartum to a friend?"|6 months postpartum|Of the 50 participants who enrolled, only 43 were available at 6 months postpartum to provide data for the first primary outcome.|||Participants|||Count of Participants
2604345|NCT02121041|Primary|24 Hour Blood Pressure Average at the End of 4 Month Participation.||Participants will be on study average of 4 months.||||mm Hg||Standard Deviation|Mean
2604346|NCT02120950|Other Pre-specified|Percentage of Subjects for Whom Rescue Therapy is Indicated Over the Course Till Week 52|Evaluations for qualification for rescue were conducted at each visit from Week 12 to Week 52. Intensified aflibercept treatment plus active or sham PDT treatments were given at any of these visits if treatment criteria were met. Qualification for rescue was based upon insufficient gain of BCVA, leakage, and presence of active polyps.|Baseline to Week 52|FAS with evaluable subjects for this outcome measure.|||Percentage of subjects|||Number
2604347|NCT02120950|Other Pre-specified|Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 52|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.|Baseline to Week 52|FAS with evaluable subjects for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2604348|NCT02120950|Other Pre-specified|Change of Central Subfield Thickness (CST) on Optical Coherence Tomography (OCT) From Baseline to Week 52|Retinal and lesion characteristics, such as central retinal thickness (CRT), were evaluated by OCT in both eyes at every study visit. CRT was measured using optical coherence tomography to determine the average thickness of the retina in a circle with 1 millimeter of diameter centered on the fovea. This value is reported by some OCT devices as central subfield thickness (CST).|Baseline to Week 52|FAS with evaluable subjects for this outcome measure.|||Millimeter||Standard Deviation|Mean
2604349|NCT02120950|Other Pre-specified|Change of Leakage Area in Fluorescein Angiography (FA) in the Study Eye at Week 52|Leakage is the release of fluorescein dye from diseased retinal vessels. Leakage area is defined as the area showing presence of fluorescein dye in the late stages of fluorescein angiography.|Baseline to Week 52|FAS with evaluable subjects for this outcome measure.|||Square millimeter||Standard Deviation|Mean
2604350|NCT02120950|Other Pre-specified|Percentage of Subjects With Complete Polyp Regression at Week 52|Complete polyp regression was defined as absent or indeterminate visual polyps on Indocyanine green angiography (ICGA) in the study eye.|Baseline to Week 52|FAS with evaluable subjects for this outcome measure.|||Percetage of subjects|||Number
2604351|NCT02120950|Other Pre-specified|Percentage of Subjects Who Lost ≥5, 10, or 15 Letters at Week 52|Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.|Baseline to Week 52|FAS|||Percentage of subjects|||Number
2604352|NCT02120950|Other Pre-specified|Percentage of Subjects Who Gained ≥5, 10, or 15 Letters at Week 52|Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.|Baseline to Week 52|FAS|||Percentage of subjects|||Number
2604353|NCT02120950|Other Pre-specified|Change of Visual Acuity (Letters) From Baseline Over Time (Week) in the Study Eye|Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.|Baseline to Week 52|FAS|||Letters||Standard Deviation|Mean
2604354|NCT02120950|Other Pre-specified|Time to First Administration of PDT in the Study Eye Before Week 52||Baseline to Week 52|FAS|||Days||Full Range|Mean
2604355|NCT02120950|Other Pre-specified|Number of Aflibercept Treatments in the Study Eye (After Randomization) Before Week 52||Baseline to Week 52|FAS with evaluable subjects for this outcome measure.|||Aflibercept injections||Standard Deviation|Mean
2604356|NCT02120950|Other Pre-specified|Number of PDT Treatments in the Study Eye Before Week 52||Baseline to Week 52|FAS|||PDT administrations||Standard Deviation|Mean
2604357|NCT02120950|Other Pre-specified|Percentage of Subjects Who Never Need Rescue Therapy in the First Year|Evaluations for qualification for rescue were conducted at each visit from Week 12 to Week 52. Intensified aflibercept treatment plus active or sham PDT treatments were given at any of these visits if treatment criteria were met. Qualification for rescue was based upon insufficient gain of BCVA, leakage, and presence of active polyps.|Baseline to Week 52|FAS|||Percentage of subjects|||Number
2604358|NCT02120950|Secondary|Percentage of Subjects Who Avoided at Least 15 Letters Loss in ETDRS at Week 52|Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.|At Week 52|FAS|||Percentage of subjects|||Number
2604359|NCT02120950|Primary|Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores From Baseline to Week 52 - Last Observation Carried Forward (LOCF)|Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.|From Baseline to Week 52|Full Analysis Set (FAS) included all randomized subjects|||Letters correctly read||Standard Deviation|Mean
2604360|NCT02120898|Other Pre-specified|Percentage of Drug Compliance|The overall drug compliance (%) = (Observed Consumption / Expected Consumption) * 100%.|Baseline (Day 1) up to Week 6|ITT population included all randomized participants who applied at least 1 dose of study drug, and returned for at least 1 post-baseline evaluation. Here 'Overall number of participants analyzed = participants evaluable for this outcome measure.|||percentage of drug compliance||Standard Deviation|Mean
2604361|NCT02120898|Secondary|Number of Participants With Local Skin Reactions|Local skin reactions included erythema, flaking/scaling/dryness, scabbing/crusting, pruritus, erosion/ulceration, pain, edema, and weeping/exudate. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline (Day 1) up to Week 14|Safety population included all randomized participants who received study drug.|||Participants|||Count of Participants
2604362|NCT02120898|Secondary|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Mild AEs: awareness of sign or symptom, but easily tolerated. Moderate AEs: discomfort sufficient to cause interference with normal activities. Severe AEs: inability to carry out usual activities. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline (Day 1) up to Week 14|Safety population included all randomized participants who received study drug.|||Participants|||Count of Participants
2604363|NCT02120898|Primary|Complete Clearance Rate - Percentage of Participants With Treatment Success: ITT Population|Complete clearance rate (treatment success) was defined as the percentage of participants in each treatment group with a count of zero AK lesions in the treatment area at Week 14. All AKs (baseline and new lesions) independent of size within the treatment area were included in the efficacy lesion count. The AK clearance rate for a participant was calculated as follows: {1 - [ (number of AK lesions at Week 14) / (number of AK lesions at Baseline)]} * 100.|Week 14|ITT population included all randomized participants who applied at least 1 dose of study drug, and returned for at least 1 post-baseline evaluation.|||percentage of participants|||Number
2604364|NCT02120898|Primary|Complete Clearance Rate - Percentage of Participants With Treatment Success: Per-Protocol (PP) Population|Complete clearance rate (treatment success) was defined as the percentage of participants in each treatment group with a count of zero actinic keratosis (AK) lesions in the treatment area at Week 14. All AKs (baseline and new lesions) independent of size within the treatment area were included in the efficacy lesion count. The AK clearance rate for a participant was calculated as follows: {1 - [ (number of AK lesions at Week 14) / (number of AK lesions at Baseline)]} * 100.|Week 14|PP population, a subset of intent-to-treat (ITT) population (all randomized participants who applied at least 1 dose of study drug, and returned for at least 1 post-baseline evaluation) included participants who met all entry criteria, complaint with study drug and completed Week 14 evaluation with no protocol violation.|||percentage of participants|||Number
2604365|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 - I Would Recommend This Product to Another Parent.|Questions were answered immediately post-treatment by participant's caregiver. Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604366|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604367|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604368|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604369|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604370|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604371|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604372|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2605028|NCT02114684|Secondary|Proportion of Patients With Any Grade 3 or 4 Adverse Reactions in the Two Study Arms|To compare the proportion of patients with any Grade 3 or 4 adverse reactions in the two study arms. Outcome measured in terms of number of participants with at least one grade 3 or 4 events, and not in number of events.|Up to 2 years||||Participants|||Count of Participants
2604373|NCT02120833|Secondary|Caregiver Questionnaire on Day 14 - Overall, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|14 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604374|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604375|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604376|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604377|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604378|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604379|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604380|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604381|NCT02120833|Secondary|Caregiver Questionnaire on Day 7 - Overall, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|7 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604382|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604383|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604384|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604385|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604386|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604387|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604388|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604389|NCT02120833|Secondary|Caregiver Questionnaire on Day 3 - Overall, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|3 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604390|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604391|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604392|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604393|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604394|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604395|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604396|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604397|NCT02120833|Secondary|Caregiver Questionnaire on Day 2 - Overall, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|2 Days|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604398|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604399|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604400|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604401|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604402|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604403|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604404|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604405|NCT02120833|Secondary|Caregiver Questionnaire on Day 1 - Overall, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|1 Day|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604406|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft and Smooth Instantly|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604407|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604408|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604409|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604410|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604475|NCT02120300|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants enrolled into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2604411|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft and Smooth Instantly|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604412|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604413|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Feels Soft|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604414|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Healthy|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604415|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Post-treatment - Overall, my Baby's Skin Looks Smooth|Questions were answered immediately post-treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|0 Days - Post-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604416|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Smooth|Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604417|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Feels Soft|Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604418|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Healthy|Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604419|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - In the Areas Affected by Eczema, my Baby's Skin Looks Smooth|Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604420|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Smooth|Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604421|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Feels Soft|Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604422|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Healthy|Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604499|NCT02120157|Secondary|Primary and Secondary Graft Failure|Number of participants with primary and secondary graft failure.|2 Years||2021-12-31|12/2021||||
2605029|NCT02114684|Secondary|Time to Culture-conversion of the Moxifloxacin Regimen and the Ethambutol Regimen|To determine the time to culture-conversion of the moxifloxacin regimen and the ethambutol regimen.|Up to 2 years||||weeks||Inter-Quartile Range|Median
2604423|NCT02120833|Secondary|Caregiver Questionnaire on Day 0 Pre-treatment - Overall, my Baby's Skin Looks Smooth|Questions were answered before treatment by participant's caregiver. Questions included overall look (smooth, healthy) and feel (soft, smooth) of participant's skin, and affected area's look (smooth, healthy) and feel (soft, smooth). Caregiver answered based on a 6 point system from 'I don't have an opinion' to 'strongly disagree.'|0 Days - Pre-Treatment|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||participants|||Number
2604424|NCT02120833|Secondary|Corneometer Measurement on Day 14 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 14, corneometer readings ranged from 5.7 to 73.1.|Baseline to Day 14|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||arbitrary units||Standard Deviation|Mean
2604425|NCT02120833|Secondary|Corneometer Measurement on Day 7 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 7, corneometer readings ranged from 6.8 to 65.0.|Baseline to Day 7|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||arbitrary units||Standard Deviation|Mean
2604426|NCT02120833|Secondary|Corneometer Measurement on Day 3 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 3, corneometer readings ranged from 8.0 to 65.3.|Baseline to Day 3|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||arbitrary units||Standard Deviation|Mean
2604427|NCT02120833|Secondary|Corneometer Measurement on Day 2 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 2, corneometer readings ranged from 8.5 to 74.0.|Baseline to Day 2|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||arbitrary units||Standard Deviation|Mean
2604428|NCT02120833|Secondary|Corneometer Measurement on Day 1 - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. On Day 1, corneometer readings ranged from 5.5 to 84.0.|Baseline to Day 1|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||arbitrary units||Standard Deviation|Mean
2604429|NCT02120833|Secondary|Corneometer Measurement on Day 0 - Post-Treatment - Change From Baseline|Corneometer is a non-invasive instrument that measures hydration on the skin surface. During assessment, the corneometer was placed at a site adjacent to eczema-affected skin areas. Corneometer readings are directly related to the skin's electrical capacitance and increase as the skin becomes more hydrated. Pre-treatment readings ranged from 2.0 to 68.0. Post-treatment on Day 0, corneometer readings ranged from 10.3 to 86.3.|Baseline to Post -Treatment on Day 0|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||arbitrary units||Standard Deviation|Mean
2604430|NCT02120833|Secondary|Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 14 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 14|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2604431|NCT02120833|Secondary|Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 7 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 7|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2604432|NCT02120833|Secondary|Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 2 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 2|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2604433|NCT02120833|Secondary|Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 1 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 1|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2605208|NCT02112045|Secondary|Overall Survival as Measured by Number of Participants Alive at Last Follow-up|OS is defined as the duration from the time of transplant Day 0 to death or last follow-up.|Up to 2 years||||Participants|||Count of Participants
2604434|NCT02120833|Secondary|Eczema Area and Severity Index (EASI) on Day 14 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 14|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2604435|NCT02120833|Secondary|Eczema Area and Severity Index (EASI) on Day 7 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 7|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2604436|NCT02120833|Secondary|Eczema Area and Severity Index (EASI) on Day 2 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 2|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2604437|NCT02120833|Secondary|Eczema Area and Severity Index (EASI) on Day 1 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 1|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2604438|NCT02120833|Primary|Investigator's Global Atopic Dermatitis Assessment (IGADA) on Day 3 - Change From Baseline|The signs and symptoms of eczema are measured using the Investigator's Global Atopic Dermatitis Assessment (IGADA). An assessment of atopic dermatitis based on a 4 point scale, ranging from 0 (none) and 3 (severe), is used to describe signs and symptoms in 4 designated body regions. Based on the presence or absence of the total number of signs and symptoms, the final rating is categorized as clear, almost clear, mild, moderate, severe, or very severe.|Baseline to Day 3|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2604439|NCT02120833|Primary|Eczema Area and Severity Index (EASI) on Day 3 - Change From Baseline|The surface and severity of eczema is measured using the Eczema Area and Severity Index (EASI). A regional body surface area tabulation based on severity ranging from 0 (none) to 3 (severe), and severity of signs of disease, then multiplied by body area with final calculation ranging from 0-72.|Baseline to Day 3|Analysis was based on Intent-to-Treat subjects, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2604440|NCT02120794|Secondary|Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups|Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c > 9%. Among the 132 subjects with both baseline and end of study A1c, 32 had A1c > 9%|Baseline and 1 year after screening||||percentage||Standard Deviation|Mean
2604441|NCT02120794|Secondary|Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups|Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c 7% to 9%. Among the 132 subjects with both baseline and end of study A1c, 97 had A1c 7% to 9%|Baseline and 1 year after screening||||percentage||Standard Deviation|Mean
2604442|NCT02120794|Secondary|Mean Change in A1C From Baseline to 1 Year, Stratified by Different A1c Subgroups|Mean change in A1C from baseline to 1 year, stratified by different A1c subgroups: A1c below 7%. Among the 132 subjects with both baseline and end of study A1c, 3 had A1c below 7%|Baseline and 1 year after screening||||percentage||Standard Deviation|Mean
2604443|NCT02120794|Primary|Overall Mean Change in A1C|The overall mean change in A1C from baseline to 1 year will be estimated and compared by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided). Among the 136 subjects who completed the study, 132 had both baseline and end of study A1c. Therefore, primary endpoint was based on 132 subjects.|Baseline and 1 year after screening||||percentage||95% Confidence Interval|Mean
2604444|NCT02120716|Secondary|Percentage of Participants Endorsing Alcohol/Drug Use at Baseline and 4-Month Follow-Up|The Timeline Followback approach was used to collect self-reported data regarding alcohol and/or drug use over a 4-month time period.|Baseline and 4-Month Follow-Up|The clustering within subject was accounted for using a generalized estimating equations (GEE) approach.|||percentage of participants|||Number
2604445|NCT02120716|Secondary|Percentage of Participants With Reduced HIV/STI Risk Behavior (Condomless Sex) From Baseline to Follow-Up.|Participants completed the Timeline Followback interview and self-reported their daily sex risk behavior including condomless sex|4 month follow up||||percentage of participants|||Number
2604446|NCT02120716|Primary|CIAS (Computerized Intervention Authoring Software) Satisfaction Measure Scores to Assess the Feasibility and Acceptability of the Computer and HCEM Software|"CIAS Satisfaction Measure (adapted from Ondersma et al., 2005). Self-report instrument assessing the extent to which participants found the software acceptable. Mean ratings on items including Likeability and Ease of use; scores range from 1 (low) to 5 (high) in satisfaction.~HCEM Satisfaction Measure. Self-report instrument assessing the extent to which participants found specific components of the HCEM intervention acceptable (e.g., videos, resources, information); scores range from 1 (low) to 7 (high) in satisfaction."|4 month follow up|Participants in the HCEM (intervention) condition reported on their satisfaction with the computer software and specific HCEM intervention components.|||units on a scale||Full Range|Mean
2604447|NCT02120664|Secondary|Variability of PET Images in Young Healthy Control Subjects.|Coefficient of variation for 11C-PiB and florbetapir (18F) SUVr. A cortical average to cerebellum SUVr was used for this outcome measure.|up to 70 minutes post injection|Young healthy controls enrolled in the study|||SUVr||Standard Deviation|Mean
2604578|NCT02119260|Secondary|Time to Occurrence of Cmax (Tmax) Following Single and Repeat Doses of GSK2798745 in Healthy Participants|Blood samples for PK analysis were obtained at Day 1 of each treatment period and Day 14 of Cohort 3 for analysis of tmax. Log untransformed values for tmax has been presented.|Day 1 (Cohort 1,2,3) and Day 14 (Cohort 3)|Pharmacokinetic Population|||hours||Full Range|Median
2604448|NCT02120664|Secondary|Correlation of Florbetapir (18F) Centiloid and 11C-PiB Centiloid|Correlation coefficient between 11C-PiB and florbetapir (18F) SUVr as converted to centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer's disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure.|up to 70 minutes post injection|All participants receiving both a florbetapir and a PiB scan per protocol. One subject in the possible AD group did not complete the florbetapir scan due to excessive movement. One subject in the at risk elderly group elected to leave the study before the second PET scan.|||centiloid||Standard Deviation|Mean
2604449|NCT02120664|Primary|Florbetapir SUVr Conversion to Centiloid Units|Conversion of florbetapir (18F) positron emission tomography (PET) standard uptake value ratio (SUVr) to Centiloid units. The Centiloid is anchored at values of 0 and 100 corresponding to the median Pittsburgh Compound B (11C-PiB) SUVr value for a representative group of young (<45) cognitively and medically healthy control subjects (YHC) and the median SUVr value for a representative group of 11C-PiB positive patients diagnosed with Alzheimer's disease, respectively. A cortical average to cerebellum SUVr was used for this outcome measure.|up to 70 minutes post injection|All participants receiving both a florbetapir and a PiB scan per protocol. One subject in the possible AD group did not complete a florbetapir scan due to excessive movement. One subject in the at risk elderly group elected to leave the study before the second PET scan.|||centiloid||Standard Deviation|Mean
2604450|NCT02120625|Secondary|Number of Participants With Serious and Non-Serious Adverse Events||Up to 6 weeks||||Participants|||Count of Participants
2604451|NCT02120625|Primary|EMG Evidence of Lesion of the Targeted Medial Branches|EMG evidence of lesion of the targeted medial branches (Percentage of positive lesions)|3-6 weeks post radiofrequency ablation||||percentage of lesions|Lesions|95% Confidence Interval|Number
2604452|NCT02120625|Primary|Volume of Lesions Were Recorded by the Reading Radiologists|Volume of lesions were recorded by the reading radiologists, including proximity to medial branches|7 days||||cubic millimeters||95% Confidence Interval|Mean
2604453|NCT02120625|Primary|Percentage of Patients With Magnetic Resonance Imaging (MRI) Evidence of Tissue Ablation/Edema at Targeted Lumbar Medial Branches|Documentation of Magnetic Resonance Imaging (MRI) evidence of tissue ablation/edema at targeted lumbar medial branches as they course around the superior articular process and transverse process juncture of the vertebrae|7 days|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production. EMG of lumbar multifidi for medial branch lesion documentation was carried out and percent of successful lesions recorded and analyzed.|||percentage of participants|||Number
2604454|NCT02120456|Secondary|Part 2: Participants With Partial Clearance of AKs (LOCF)|Partial clearance was defined as at least 75% reduction from baseline in AK count.|From baseline to Week 8||||Participants|||Count of Participants
2604455|NCT02120456|Secondary|Part 2: Participants With Complete Clearance of AKs (Last Observation Carried Forward [LOCF])|Complete clearance was defined as a 100% reduction from baseline in AK count.|From baseline to Week 8||||Participants|||Count of Participants
2604456|NCT02120456|Primary|Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Count|Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) identified in the treatment area.|From baseline to Week 8||||percentage of reduction||95% Confidence Interval|Mean
2604457|NCT02120456|Primary|Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)|"The number participants experiencing a DLT was used to identify the maximum tolerated dose(MTD) levels of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level at which less than 4 out of 12 participants experienced a DLT.~A DLT was defined as one or more of the following three LSRs:~Crusting Grade 4~Erosion/Ulceration Grade 4~Vesiculation/Pustulation Grade 4~or two or more of the following five LSRs:~Crusting Grade 3~Swelling Grade 4~Erosion/Ulceration Grade 3~Vesiculation/Pustulation Grade 3~or other clinically relevant signs or symptoms observed, which the Investigator judged to be counted as a DLT.~The LSRs consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category was given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity."|From Day 1 up to and including Day 8||||Participants|||Count of Participants
2604458|NCT02120443|Secondary|Significant Skin Irritation or Disruption to Skin Integrity|The number of IV sites with significant skin irritation or disruption to skin integrity assessed at the end of the study. The Clopper-Pearson method was used for estimating the binomial proportion confidence interval.|24 hours|Three participants were excluded for significant protocol deviations.|||IV sites||95% Confidence Interval|Number
2604459|NCT02120443|Secondary|Normal Tissue Yellow Notification Rate|The ivWatch Model 400 issues yellow notifications to communicate the need for a clinician to check an IV site. A yellow notification suggests an increased likelihood that an IV infiltration may be occurring, although at a lower likelihood relative to a red notification. This measure describes the average number of yellow notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the yellow notification rate was calculated using the Clopper-Pearson method.|24 hours|Three participants were excluded due to significant protocol deviations.|||yellow notifications per day||95% Confidence Interval|Mean
2604460|NCT02120443|Primary|Normal Tissue Red Notification Rate|The ivWatch Model 400 issues red notifications to communicate the need for a clinician to check an IV site. A red notification suggests an increased likelihood that an IV infiltration may be occurring, with a greater likelihood relative to a yellow notification. This measure describes the average number of red notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the red notification rate was calculated using the Clopper-Pearson method.|24 hours|Three subjects were excluded from analysis due to significant protocol deviations.|||red notifications per day||95% Confidence Interval|Mean
2605175|NCT02112877|Other Pre-specified|Number of Participants With Lesion Success|Lesion success is defined as achievement of ≤50% residual diameter stenosis of the target lesion using any percutaneous method (including the use of non-study devices).|During Procedure|For the pivotal cohort, four subjects did not have the post-procedural veogram available for assessment.|||Participants|||Count of Participants
2604461|NCT02120417|Primary|Percentage of Participants Achieving Overall Survival|Overall survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.|Randomization until death due to any cause at month 3, 6, 9, 12 and 15 or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.|||percentage of participants||95% Confidence Interval|Number
2604462|NCT02120417|Secondary|Percentage of Participants Achieving Clinical Benefit Rate|Clinical benefit rate was defined as a complete response, partial response, or stable disease, determined by investigator assessment of objective radiographic disease assessments per RECIST (v1.1) that lasted for ≥ 6 months. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Randomization through end of study up to 19 months or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.|||percentage of participants|||Number
2604463|NCT02120417|Secondary|Duration of Response (DOR)|The DOR was defined as the difference (in number of months) between the end of response and the start of response for participants who had at least 1 response measurement. The start of a response was the first visit where the participant achieved a partial response or better based on RECIST (v1.1) criteria. The end of response was the earlier of death or progressive disease based on RECIST (v1.1) criteria. The date of progressive disease was the date on which progression was first recorded. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Randomization through end of study up to 19 months or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.|||months||80% Confidence Interval|Median
2604464|NCT02120417|Secondary|Percentage of Participants Achieving Objective Response Rate|Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Randomization through end of study up to 19 months or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.|||percentage of participants|||Number
2604465|NCT02120417|Secondary|Progression-free Survival (PFS)|Progression-free survival was defined as the time from the randomization date to the earliest date of disease progression, as measured by investigator assessment of objective radiographic disease assessments per RECIST (v1.1), or death from any cause if earlier. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method.|Randomization to disease progression, or death due to any cause if sooner up to 19 months or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.|||months||95% Confidence Interval|Median
2604466|NCT02120417|Primary|Median Survival|Survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.|Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.|||months||95% Confidence Interval|Median
2604467|NCT02120417|Primary|Overall Survival (OS)|Overall survival is reported here by the number of days from randomization to death until the data cutoff for the final analysis. The hazard ratio (80% CI) for ruxolitinib versus placebo was estimated using a Cox regression model stratified by hormone-receptor status.|Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.|The Intent-to-Treat (ITT) population consisted of all participants randomized to the study.|||Participants|||Count of Participants
2604468|NCT02120300|Secondary|Change From Baseline in Serum Creatinine at the End of Treatment and at Posttreatment Week 12 (HIV-1/HCV Co-infected Participants Only)||Baseline; Weeks 12, 24, and Posttreatment Week 12|Participants coinfected with HIV-1 and HCV in the Safety Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
2604469|NCT02120300|Secondary|Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL at Weeks 4, 8, 12, 16, 20, and 24 (HIV-1/HCV Co-infected Participants Only)||Weeks 4, 8, 12, 16, 20, and 24|Only the participants coinfected with HIV-1 and HCV in the Safety Analysis Set with available data were analyzed.|||percentage of participants|||Number
2604470|NCT02120300|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2604471|NCT02120300|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, 12, 16, 20, and 24||Baseline; Weeks 1, 2, 4, 8, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2604472|NCT02120300|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24||Weeks 1, 2, 4, 8, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2625610|NCT01910389|Secondary|Cardiovascular Mortality||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.||||||
2604476|NCT02120287|Secondary|Functional Assessment of Cancer Therapy-Brain Specific Symptom Index (FACT-BrSI)|"The FACT-BrSI subscale, brain tumor specific version (2007), is a 15-item, patient completed, questionnaire.This brain subscale is used along with the core (general) questionnaire (FACT-G) that includes 27 items. Patients rate all items using a five-point Likert scale ranging from 0 not at all to 4 very much. Overall, higher ratings suggest higher quality of life (QOL). The FACT BrSI has a range of 0-60, where a higher score indicates less symptomatology."|At 8 weeks|Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).|||score on a scale||95% Confidence Interval|Mean
2604477|NCT02120287|Secondary|Functional Assessment of Cancer Therapy-Brain Specific Symptom Index (FACT-BrSI)|"The FACT-BrSI subscale, brain tumor specific version (2007), is a 15-item, patient completed, questionnaire.This brain subscale is used along with the core (general) questionnaire (FACT-G) that includes 27 items. Patients rate all items using a five-point Likert scale ranging from 0 not at all to 4 very much. Overall, higher ratings suggest higher quality of life (QOL). The FACT BrSI has a range of 0-60, where a higher score indicates less symptomatology."|At baseline (Week 0) prior to treatment administration|Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).|||score on a scale||95% Confidence Interval|Mean
2604478|NCT02120287|Secondary|Functional Assessment of Cancer Therapy-General - General (FACT-G)|The FACT-G is a patient rated, 27-item compilation of general questions divided into 4 primary Quality of Life (QOL) sub-scales: physical well-being (PWB; 7-items, score range 0-28), social/family well-being (SWB; 7-items, score range 0-28), emotional well-being (EWB; 6-items, score range 0-24), and functional well-being (FWB; 7-items, score range 0-28). This tool represents the generic core questionnaire that are utilized in combination with cancer site-specific questionnaires, (FBrain, in this study) Overall score and four subscale scores with ranges and distributions that are sample-specific can be calculated.FACT-G is scored by summing the individual scale scores; higher scores indicate better quality of life. FACT-G uses 5-point rating scale ranging from (0) = Not at all; (1) = A little bit; (2) = Somewhat; (3) = Quite a bit; to (4) = Very much.The FACT-G total score is the sum of the four subscale scores (if least 80% completed) and has a possible range of 0-108 points.|At 8 weeks|Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).|||score on a scale||95% Confidence Interval|Mean
2604479|NCT02120287|Secondary|Functional Assessment of Cancer - General (FACT-G)|The FACT-G is a patient rated, 27-item compilation of general questions divided into 4 primary Quality of Life (QOL) sub-scales: physical well-being (PWB; 7-items, score range 0-28), social/family well-being (SWB; 7-items, score range 0-28), emotional well-being (EWB; 6-items, score range 0-24), and functional well-being (FWB; 7-items, score range 0-28). This tool represents the generic core questionnaire that are utilized in combination with cancer site-specific questionnaires, (FBrain, in this study) Overall score and four subscale scores with ranges and distributions that are sample-specific can be calculated.FACT-G is scored by summing the individual scale scores; higher scores indicate better quality of life. FACT-G uses 5-point rating scale ranging from (0) = Not at all; (1) = A little bit; (2) = Somewhat; (3) = Quite a bit; to (4) = Very much.The FACT-G total score is the sum of the four subscale scores (if least 80% completed) and has a possible range of 0-108 points.|At baseline (Week 0) prior to treatment administration|Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg). (NOTE: One participant did not complete the EWB section of the questionnaire. One participant did not complete the FWB section of the questionnaire.)|||score on a scale||95% Confidence Interval|Mean
2604480|NCT02120287|Secondary|Center for Epidemiological Studies Depression Scale (CES-D)|An assessment comprised of 20 statements for which the participant is asked to indicate how often they have felt a certain way during the past week. SCORING: zero for answers of Rarely or none of the time (less than 1 day), 1 for answers of Some or a little of the time (1-2 days), 2 for answers of Occasionally or a moderate amount of time (3-4 days) the third column, 3 for answers of Most or all of the time (5-7 days). The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more depression symptomatology.|At 8 weeks|Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).|||score on a scale||95% Confidence Interval|Median
2604481|NCT02120287|Secondary|Center for Epidemiological Studies Depression Scale (CES-D)|An assessment comprised of 20 statements for which the participant is asked to indicate how often they have felt a certain way during the past week. SCORING: zero for answers of Rarely or none of the time (less than 1 day), 1 for answers of Some or a little of the time (1-2 days), 2 for answers of Occasionally or a moderate amount of time (3-4 days) the third column, 3 for answers of Most or all of the time (5-7 days). The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more depression symptomatology.|At baseline (Week 0) prior to treatment administration|Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).|||score on a scale||95% Confidence Interval|Median
2604482|NCT02120287|Secondary|Barthel's Index of Activities of Daily Living Assessment|The Barthel Index consists items assessing the ability to achieve certain activities without assistance. It evaluates the ability of feeding, moving from wheelchair to bed and returning, doing personal toilet, getting on and off toilet,bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. Scoring ranged from 0 (completely dependent) to 20 (completely independent) for this assessment. A maximal score of 20 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.|At 8 weeks|Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).|||score on a scale||95% Confidence Interval|Mean
2604579|NCT02119260|Secondary|Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of GSK2798745 in Healthy Participants|Blood samples for PK analysis were obtained at Day 1 and Day 14 of each treatment period for analysis of Cmax. Log transformed values for Cmax has been presented.|Day 1 (Cohort 1,2,3) and Day 14 (Cohort 3)|Pharmacokinetic Population|||ng/mL||Standard Deviation|Mean
2604483|NCT02120287|Secondary|Barthel's Index of Activities of Daily Living Assessment|The Barthel Index consists items assessing the ability to achieve certain activities without assistance. It evaluates the ability of feeding, moving from wheelchair to bed and returning, doing personal toilet, getting on and off toilet,bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. Scoring ranged from 0 (completely dependent) to 20 (completely independent) for this assessment. A maximal score of 20 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.|At baseline (Week 0) prior to treatment administration|Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).|||score on a scale||95% Confidence Interval|Mean
2604484|NCT02120287|Secondary|Karnofsky Performance Status|The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. Score range from 0 to 100; the lower the Karnofsky score, the worse the survival for most serious illnesses. A score of 100 would indicate 'Normal no complaints; no evidence of disease.' A score of 50 indicates 'Requires considerable assistance and frequent medical care.' A score of 0-10 would indicate 'Moribund; fatal processes progressing rapidly' and 'Death'.|At baseline (Week 0) prior to treatment administration|Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).|||participants|||Number
2604485|NCT02120287|Secondary|Potential Value of Magnetic Resonance Spectroscopy (MRS)|"Improvement of border zone target selection and detection of therapeutic response of the derived treatment volumes between MRI and MRI+MRS (Magnetic Resonance Spectroscopy).~This is presented as the number of patients for whom the derived treatment was changed as a result of the utilization of MRS."|Prior to radiosurgery|Participants who received MRS (Magnetic Resonance Spectroscopy) scans prior to radiosurgery.|||number of participants|||Number
2604486|NCT02120287|Secondary|Tumor Response|Proportion of patients with a best response of CR, PR, SD, PD: number of patients with CR, PR, SD or PD / total number of patients evaluable for response to treatment of border zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab.|Up to 2 years|Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).|||Proportion of participants||95% Confidence Interval|Number
2604487|NCT02120287|Secondary|CNS Toxicity|The number of patients experiencing a CNS toxicity type occurring within 3 months of gamma knife surgery, as measured by RTOG/EORTC Acute Radiation Morbidity Scoring and the NCI CTCAE v4.0 for late toxicity.|Six months after SRS|Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).|||number of participants|||Number
2604488|NCT02120287|Secondary|6-month Overall Survival|The proportion of patients who remained alive as of 6 months from the date of radiosurgery. Proportion of patients for OS = number of patients alive at 6 months post radiosurgery / total number of patients.|At 6 months|Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).|||proportion of participants||95% Confidence Interval|Number
2604489|NCT02120287|Secondary|6-month Progression-free Survival|The proportion of patients who did not experience disease progression per RANO as of 6 months from the date of radiosurgery. RANO (Response Assessment in Neuro-Oncology) Response Criteria for Progression using imaging features: 25% or more increase in enhancing lesions despite stable or increasing steroid dose increase (significant) in non-enhancing FLAIR/T2W lesions, not attributable to other non-tumor causes any new lesions clinical features clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease). Proportion of patients for PFS = number of patients without disease at 6 months post radiosurgery / total number of patients.|At 6 months|Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).|||proportion of participants||95% Confidence Interval|Number
2604490|NCT02120287|Primary|Overall Survival (OS)|The number of months that a patient remains alive from the day first gamma knife surgery until the date of death or end of data collection for survival.|Up to 2 years|Patients with recurrent or Progressive Glioblastoma Multiforme who underwent treatment of border Zone Stereotactic Radiosurgery (BZ-SRS) with bevacizumab (10 mg/kg).|||months||95% Confidence Interval|Median
2604491|NCT02120261|Secondary|Duration of Pain Relief|If the patient experienced pain relief with the trigger point injection and the pain came back later, the number of days after the injection at which the pain had returned was recorded.|16 days||||days||Full Range|Median
2604492|NCT02120261|Primary|Pain Intensity|The level of pain intensity is quantified using a standard 0-10 Numerical Rating Scale with 10 being the most severe pain intensity and 0 the absence of pain.|2 weeks|Pain intensity was not measured in 6 subjects in the TPI with Normal Saline arm and 4 subjects in the TPI with Lidocaine & Triamcinolone Acetonide arm.|||units on a scale||Standard Deviation|Mean
2604493|NCT02120261|Primary|Pain Intensity|The level of pain intensity is quantified using a standard 0-10 Numerical Rating Scale with 10 being the most severe pain intensity and 0 the absence of pain.|at discharge (a few minutes after receiving intervention)||||units on a scale||Standard Deviation|Mean
2604494|NCT02120261|Primary|Pain Intensity|The level of pain intensity is quantified using a standard 0-10 Numerical Rating Scale with 10 being the most severe pain intensity and 0 the absence of pain.|baseline||||units on a scale||Standard Deviation|Mean
2604495|NCT02120157|Secondary|Immune Reconstitution|Characterize immune reconstitution post myeloablative haploidentical BMT with Post transplantation cyclophosphamide (PT/Cy).|Two Years|||||||
2604496|NCT02120157|Secondary|Hematologic and Non-hematologic Toxicities|Assess hematologic and non-hematologic toxicities of myeloablative haploidentical BMT.|Two Years|||||||
2604497|NCT02120157|Secondary|Survival|Estimate overall survival (OS), progression-free survival (PFS), disease-free survival (DFS), event-free survival, and relapse-free GVHD-free survival (GRFS) in patients receiving myeloablative, HLA-mismatched BMT for patients with high risk hematologic malignancies at 1 year and 2 years.|up to 2 years|||||||
2604498|NCT02120157|Secondary|Steroid and Non-steroid Immunosuppressants|Characterize the duration of use, number, and type of steroid and non-steroid immunosuppressants used to treat GVHD.|Two Years||2021-12-31|12/2021||||
2604500|NCT02120157|Secondary|Acute Graft Versus Host Disease (GVHD) Grades 2-4 and Grades 3-4|Number of participants with acute GVHD grades 2-4 and grades 3-4. Acute GVHD Grade 0= no skin, liver or gut involvement; Grade I= Stage 1-2 skin involvement, no liver or gut involvement; Grade II= Stage 3 skin, and/or Stage 1 liver, and/or Stage 1 gut involvement; Grade III= Stage 3 or no skin involvement, Stage 2-3 liver or Stage 2-4 gut involvement; Grade IV= Stage 4 skin or Stage 4 liver involvement. Skin involvement is staged as follows: 1= rash <25% body surface area (BSA), 2= rash 25-50% BSA, 3= rash >50% BSA, 4= generalized erythroderma with bullae. Gastrointestinal (gut) involvement is staged as follows: 1= diarrhea 500-1000 mL/day or 280-555 mL/m^2, or persistent nausea; 2= diarrhea 1000-1499 mL/day or 556-833 mL/m^2; 3= diarrhea >1500 mL/day or >833 mL/m^2; 4= large volume of diarrhea and severe abdominal pain with/without ileus. Liver involvement is staged as follows: 1= bilirubin 2-3mg/dL, 2= bilirubin 3-6mg/dL, 3= 6-15mg/dL, bilirubin >15 mg/dL|2 Years||2021-12-31|12/2021||||
2604501|NCT02120157|Secondary|Number of Participants With Donor Cell Engraftment|Number of Participants with Donor Cell Engraftment at Day 60 following myeloablative, HLA-mismatched BMT.|Day 60||||Participants|||Count of Participants
2604502|NCT02120157|Primary|Incidence of Mortality|Number of patients with non-relapse mortality at 180 days following myeloablative, HLA-mismatched bone marrow transplant (BMT) for patients with high risk hematologic malignancies|Day 180||||Participants|||Count of Participants
2604503|NCT02120027|Secondary|Sustained Analysis of Response for Abdominal Pain AND Stool Consistency Over First 24-week Double-blind Treatment Period|Weekly response for abdominal pain intensity AND stool consistency over the first 24 weeks of treatment in at least 50% of the weeks of treatment (12 out of 24 weeks) with at least 2 weeks of response in the last 4 weeks of treatment (week 21 to 24). The patient will be considered a weekly responder as defined for the primary endpoint.|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.|||Participants|||Count of Participants
2604504|NCT02120027|Secondary|Weekly Response for Relief of Overall IBS Signs and Symptoms Over the First 24 Weeks of Treatment in at Least 50% of the Weeks (12 Out of 24)|"The patient was considered a weekly responder if she has an IBS degree-of-relief equal to completely relieved/improved or considerably relieved/improved.~Weekly e-diary assessment of IBS degree-of-relief of overall on signs or symptoms over the last 7 days was collected using a balanced 7-point Likert scale with 1= Completely relieved/improved, 2= Considerably relieved/improved, 3=Somewhat relieved/improved, 4= Unchanged, 5= Somewhat worse, 6=Considerably worse, 7= As bad as I can imagine."|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.|||Participants|||Count of Participants
2604505|NCT02120027|Secondary|Weekly Response for Stool Consistency Over the First 24 Weeks of Treatment in at Least 50% of the Weeks of Treatment (12 Out of 24 Weeks).|"The patient was considered a weekly stool consistency responder if she met the following criterion:~Decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline."|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.|||Participants|||Count of Participants
2604506|NCT02120027|Secondary|Weekly Response for Abdominal Pain Intensity Over the First 24 Weeks of Treatment in at Least 50% of the Weeks of Treatment (12 Out of 24 Weeks).|"The patient will be considered a weekly abdominal pain responder if she meets the following criterion:~Decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline."|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.|||Participants|||Count of Participants
2604507|NCT02120027|Primary|Weekly Response for Abdominal Pain Intensity AND Stool Consistency Over the First 24 Weeks of Treatment in at Least 50% of the Weeks of Treatment (12 Out of 24 Weeks).|"The patient will be considered a weekly responder if she meets both of the following criteria in the same week:~Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline (patients reported their worst abdominal pain on a 0 to 10 NRS scale, where 0 corresponds to no pain and 10 corresponds to worst possible pain);~Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline (patients reported their stool consistency response using the Bristol Stool Chart score based on a 1 to 7 NRS scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea)."|24 weeks|Modified ITT (mITT) Population: all patients included in the ITT population excluding patients from site 00179 (N=48), where a potential serious breach of Good Clinical Practice was reported, and site 00186 (N=34), where disqualification proceedings against the Investigator were initiated by the US Food and Drug Administration.|||Participants|||Count of Participants
2604508|NCT02120001|Secondary|Microbiological Colonization of Distal Airways|Investigators will collect data about distal airways samples performed for clinical reasons during the study period and, in addition, investigators will collect a specimen from the distal airways immediately before extubation.|At extubation (An expected average of 7 days)||||Log colony form unit (CFU)/ mL||Standard Deviation|Mean
2604509|NCT02120001|Primary|Endotracheal Tube Colonization|Discarded ETTs will be collected after extubation and sent for quantitative and qualitative microbiological analysis after silver ion inactivation. Qualitative analysis was based on confocal microscopy, we described visually the distribution of microbial colonization. However, we did not report numerical value because the confounding factors (i.e., number and length of devices).|At extubation (an expected average of 7 days)||||Log colony form unit (CFU)/ mL||Standard Deviation|Mean
2605277|NCT02111252|Secondary|Geometric Mean Titer (GMT) of HI Antibody Titer|Geometric mean titer (GMT) of HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination|Day 22|The full analysis set was used.|||titer||95% Confidence Interval|Geometric Mean
2604510|NCT02119936|Secondary|Change in Warwick Edinburgh Mental Well Being Scale From Baseline to In-patient Follow up (5-7 Days).|The Warwick Edinburgh Mental Well Being Scale is a 14 item self-report measure assessing subjective well-being (1-5 scale). Higher values represent more positive mental well being. The summary measure is a sum of the 14 questions (not a mean). Summary values therefore range from 14-70.|Baseline to in-patient follow-up (5 to 7 days in between)|All participants were discharged from the antepartum unit prior to 5-7 days in-patient so these study data were not collected.||||||
2604511|NCT02119936|Secondary|Change in Linear Analog Self-Assessment (LASA) From Baseline to In-patient Follow up (5-7 Days).|The Linear Analog Self-Assessment (LASA) form measures patient quality-of-life. Scores range from 6-30 with higher scores indicative of greater well-being.|Baseline to in-patient follow-up (5 to 7 days in between)|All participants were discharged from antepartum unit prior to 5-7 days in-patient so these study data were not collected.||||||
2604512|NCT02119936|Secondary|Correlation of HRVB Feedback With Varying Levels of Clinical Depression and Anxiety|The investigators will stratify our population based on the depression screen used at the baseline visit. These groups will include those with severe, moderate, or lack of depression. The investigators will then compare these groups to the finds from the surveys on maternal mood and the difference noticed among the groups due to the HRVB tools.|Baseline to in-patient follow-up (5 to 7 days in between)|All participants were discharged from the antepartum unit prior to 5-7 days in-patient so these data were not collected.||||||
2604513|NCT02119936|Secondary|Association Between HRVB and High-Frequency Heart Rate Variability (HF-HRV)|The investigators will measure HF-HRV in 1-minute segments during HRVB, and will test whether coherence score, as recorded by the HRVB device, correlates with HF-HRV.|Baseline to in-patient follow-up (5 to 7 days in between)|HF-HRV data was not collected||||||
2604514|NCT02119936|Secondary|Change in State-Trait Anxiety Inventory From Baseline to In-patient Follow up (5-7 Days).|State-trait anxiety scores range from 40-80 with higher scores indicative of greater anxiety|Baseline to in-patient follow-up (5 to 7 days in between)|No in-patient follow up was completed due to patients moving off antepartum unit prior to meeting the 5-7 day in-patient criteria||||||
2604515|NCT02119936|Primary|Feasibility of Using HRVB Among Hospitalized Pregnant Women|The investigators will report rates of enrollment among women approached to join the study, rates of longitudinal data collection, and loss to follow-up.|Baseline, in-patient follow-up (5 to 7 days after baseline), and follow-up phone call (6 to 8 weeks post in-patient follow-up)||||Participants|||Count of Participants
2604516|NCT02119871|Secondary|Duration of the De-airing Procedure|Duration of the de-airing procedure counted in minutes.|Duration in minutes fråm removal of the aortic cross clamp to finished de-airing, an average of 10-15 minutes.|Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.|||minutes||Inter-Quartile Range|Median
2604517|NCT02119871|Primary|Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.|The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and the aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows: Grade 0: no residual air emboli, Grade I: air emboli observed in one of three anatomic areas, Grade II: air emboli observed simultaneously in two of three anatomic areas, Grade III: air emboli observed simultaneously in all three anatomic areas.|7-10 minutes after finished de-airing|Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.|||Participants|||Count of Participants
2604518|NCT02119871|Primary|Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.|The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and the aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows: Grade 0: no residual air emboli, Grade I: air emboli observed in one of three anatomic areas, Grade II: air emboli observed simultaneously in two of three anatomic areas, Grade III: air emboli observed simultaneously in all three anatomic areas.|3-6 minutes after finished de-airing|Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.|||Participants|||Count of Participants
2604519|NCT02119871|Primary|Number of Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.|The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and the aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows: Grade 0: no residual air emboli, Grade I: air emboli observed in one of three anatomic areas, Grade II: air emboli observed simultaneously in two of three anatomic areas, Grade III: air emboli observed simultaneously in all three anatomic areas.|0-3 minutes after finished de-airing|Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.|||Participants|||Count of Participants
2604520|NCT02119871|Primary|Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery|Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and the left middle cerebral artery will be reported.|Period of ten minutes after finished de-airing|Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.|||gaseous cerebral microemboli||Inter-Quartile Range|Median
2604521|NCT02119871|Primary|Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery|Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and the left middle cerebral artery will be reported.|Time from cardiac ejection to finished de-airing, an average on 5-10 minutes|Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent.|||gaseous cerebral microemboli||Inter-Quartile Range|Median
2605333|NCT02110706|Primary|Safety:Percentage of Study Participants With Treatment-related Adverse Experiences|Evaluate treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|52 weeks|Intention to treat participants|||Participants|||Count of Participants
2604522|NCT02119871|Primary|Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery|Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and the left middle cerebral artery will be reported.|Time from the release of the aortic crossclamp to cardiac ejection, an average of 5-10 minutes|Groups were statistically compared to a historical control group of 10 patients with bilateral open pleurae and left ventricular apical vent (LVAV) in order to evaluate:1. the impact on de-airing of unilateral open pleura compared to bilateral open pleurae, and 2. the impact on de-airing of a right superior pulmonary vein vent compared to LVAV.|||gaseous cerebral microemboli||Inter-Quartile Range|Median
2604523|NCT02119676|Secondary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)|TEAEs were defined as any adverse event (AE) during the study that began or worsened on or after the date of first dose of investigational product.|Baseline through approximately 30 days post treatment discontinuation;up to 16 months or data cut-off 27JAN 2016 for Substudy 1 and up to the data cut-off of 11FEB2016 for Substudy 2.|Safety Population consists of all enrolled participants that received at least one dose of study drug.|||percentage of participants|||Number
2604524|NCT02119676|Secondary|Percentage of Participants Achieving Disease Control|Disease control as measured by the percentage of participants whose best response was complete response (CR), partial response (PR), or stable disease (SD) per RECIST v.1.1.|Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016.|Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.|||percentage of participants||95% Confidence Interval|Number
2604525|NCT02119676|Secondary|Duration of Response|Duration of response is defined as the time from response (CR/PR) until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause.|Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016.|No data displayed because outcome measure has not been analyzed. Duration of response analyses was not done since there were no responders in Substudy 1 and very few responders in Substudy 2 at data cutoff (27JAN2016 for Substudy 1 and 11Feb2016 for Substudy 2). Duration of response analysis was not done in both substudies.||||||
2604526|NCT02119676|Secondary|Overall Response Rate (ORR)|Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target and non-target lesions without new lesion; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions, non-target lesion not progressed, and no new lesion; Progressive Disease=20% increase in sum of longest diameter of target lesions, or non-target lesion progression, or identification of new lesion; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants randomized.|Baseline through end of study; up to 16 months or data cut-off 11 FEB 2016.|Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.|||percentage of responders||95% Confidence Interval|Number
2604527|NCT02119676|Secondary|Progression Free Survival (PFS)|Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the Longest Diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.|Baseline through disease progression, or death due to any cause if sooner; up to 16 months or data cut-off 11 FEB 2016.|Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.|||months||95% Confidence Interval|Median
2604528|NCT02119676|Primary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death due to any cause. Participants without death observed at the time of the analysis will be censored at last date known to be alive. The median overall survival time was estimated using the Kaplan-Meier method. Overall survival was compared between treatment groups using log-rank test.|Baseline until death due to any cause; up to 16 months or data cut-off 11 FEB 2016.|Intent-to-treat (ITT) population included all subjects randomized in Substudy 1 and Substudy 2 of the study.|||months||95% Confidence Interval|Median
2604529|NCT02119663|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug (ruxolitinib or placebo). A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).|Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.|The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).|||Participants|||Count of Participants
2604530|NCT02119663|Secondary|Duration of Response|Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) until the first date Progressive Disease (PD) was objectively documented or until the date of death. Per RECIST for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||days||95% Confidence Interval|Median
2604580|NCT02119260|Secondary|Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC[0-inf]) Following Single and Repeat Doses of GSK2798745 in Healthy Subjects|Blood samples for Pharmacokinetic (PK) analysis were obtained at Day 1 of each treatment period for analysis of AUC[0-inf]. Log untransformed values for AUC[0-inf] has been presented. The 'PK Population' includes 'All Subjects' population for whom a pharmacokinetic sample was obtained and analyzed.|Day 1|Pharmacokinetic Population|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
2604531|NCT02119663|Secondary|Objective Response Rate (ORR)|Objective response rate determined by radiographic disease assessments per Response Evaluation Criteria in Solid Tumours RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by RECIST at any post baseline visit. Per RECIST for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||percentage of participants|||Number
2604532|NCT02119663|Secondary|Percentage of Participants Achieving Progression Free Survival (PFS)|PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.|Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||percentage of participants||95% Confidence Interval|Median
2604533|NCT02119663|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.|Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||days||95% Confidence Interval|Median
2604534|NCT02119663|Primary|Overall Survival (OS)|Overall survival is reported here based on the number of deaths from randomization until the data cut-off.|Randomization until death due to any cause up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||Participants|||Count of Participants
2604535|NCT02119650|Secondary|Participants With Treatment-emergent Adverse Events (TEAEs)|A treatment-emergent AE was defined as an event occurring (or worsening of any pre-existing) after exposure to at least 1 dose of study drug. A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).|Baseline through approximately 30 days post treatment discontinuation; up to 16 months or to the data cutoff 11FEB2016.|The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug.|||Participants|||Count of Participants
2604536|NCT02119650|Secondary|Duration of Response|For objective responders, the duration of response is defined as the difference of the end of response and the start of response. The start of a response was the first visit where the subject achieves PR or better based on RECIST v1.1 criteria. The end of response was the first visit after PD based on RECIST v1.1 criteria.|From the start of response to the end of response; up to 16 months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of participants that were randomized in the study.|||weeks||80% Confidence Interval|Median
2604537|NCT02119650|Secondary|Objective Response Rate (ORR)|Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Baseline through end of study; up to 16 months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of participants that were randomized in the study.|||Participants|||Count of Participants
2604538|NCT02119650|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum Longest Diameter (LD) recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions or increase in disease burden for subjects with only nonmeasurable disease.|Randomization to disease progression, or death due to any cause if sooner; up to 16 months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of participants that were randomized in the study.|||Months||95% Confidence Interval|Median
2604539|NCT02119650|Primary|Overall Survival (OS)|Overall survival is defined as the time from randomization to death due to any cause. Participants without death observed at the time of the analysis were censored at last date known to be alive. The median overall survival time was estimated using the Kaplan-Meier method. Overall survival was compared between treatment groups using log-rank test.|Randomization until death due to any cause; up to 16 months or data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of participants that were randomized in the study.|||months||80% Confidence Interval|Median
2604540|NCT02119455|Secondary|Oral Health Quality of Life|To assess the impact of the vibration appliance on the overall oral health quality of life of the subject, subjects will be given an Oral Health Impact Profile (OHIP-14) questionnaire. The OHIP-14 consists of 14 question areas divided into specific dimensions including functional limitation, physical pain, psychological discomfort, physical disability, psychological and social disability and overall life handicap from orthodontic treatment with or without the vibration appliance. For the OHIP questionnaire, responses are coded 0 (never or not applicable), 1 (hardly ever), 2 (occasionally), 3 (fairly often) or 4 (very often). As a general rule, the greater the OHIP score, the more of an impact a particular intervention had on the patient's overall quality of life. The scores for the overall OHIP-14 range from 0-56, with values closer to 0 indicating minimal impact on quality of life and values closer to 56 indicating great impact on quality of life.|Up to Week 17|All subjects (40 total).|||Units on OHIP-14 Scale||Standard Deviation|Mean
2604541|NCT02119455|Secondary|Orthodontic Pain Assessment|"Subjects will be given a pain diary on the baseline (T0), visits T1 & T2 to record the level of orthodontic pain each evening for the first 7 days after each study visit. The degree of pain was assessed using a metric Visual Analog Scale. The patient was given a scale that was a 100 mm in length. At 0 mm on the scale line, the pain level would be 0 indicating no pain. At the higher end of the line scale (the 100 mm mark), the pain level was considered the most severe. Data presented here indicates the mean VAS scores in mm for the 1st week following each study visit. The average values indicate the measure along the scale."|Up to Week 17|All subjects (40 total).|||mm||Standard Deviation|Mean
2604542|NCT02119455|Secondary|Tooth Mobility|The degree of tooth mobility will be used using a Periotest device (Siemens, Bensheim, Germany) on the central incisors, canines and 2nd premolars in both mandibular quadrants as previously described by Liou et al. The archwire will be removed and the Periotest measurements will be taken in triplicate, with means recorded. The Periotest's scale ranges from -8 to +50. The lower the Periotest value, the higher is the stability / damping effect of the test object (tooth or implant). -8 to 0 indicates high stability with minimal movement, +1-+9 indicates some degree of mobility (moderate) and +10 to +50 indicates severe mobility.|Up to Week 17|All subjects (40 total).|||PTV||Standard Deviation|Mean
2604543|NCT02119455|Primary|Alignment of Mandibular Anterior Teeth|At each study visit, alginate impressions will be taken on each subject. These models will be analyzed by 2 examiners to calculate the alignment based on Little's Irregularity Index. Measure Description: Little's Irregularity index measures the interproximal contact displacement in mm between the anterior teeth segment from the mesial of the canine on one side to the mesial aspect of the contralateral canine.|Up to Week 17|All subjects (40 total)|||mm||Standard Deviation|Mean
2604544|NCT02119455|Primary|Changes in the Expression of Salivary Biomarkers of Bone Remodeling|Saliva will be collected as T0 (Baseline), T1 (5-6 weeks), T2 (10-12 weeks), T3 (15-17 weeks). Saliva will be analysed for a variety of biomarkers with protein quantified by ELISA assay at each time point for each subject.|Up to Week 17 of alignment (From T0 to T3)|Vibration and Control subjects-- all subjects in the study averaged across all time points per group.|||pg/mL||Standard Deviation|Mean
2604545|NCT02119442|Primary|Number of Participants Who Developed Infective Endocarditis|The investigator will be assessing the efficacy of transcatheter heart valve (THV) by evaluating survival and development of infective endocarditis as an adverse event.|8 years||||participants|||Number
2604546|NCT02119325|Secondary|Tmax for Insulin in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||minutes||Standard Deviation|Mean
2604547|NCT02119325|Secondary|AUC for Insulin in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||µIU*min/mL||Standard Deviation|Mean
2604548|NCT02119325|Secondary|Cmax for Insulin in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||µIU/mL||Standard Deviation|Mean
2604549|NCT02119325|Secondary|Tmax for Insulin in IFG Status Participants|To evaluate the effect of fibre rich health food drink on Tmax for insulin in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||minutes||Standard Deviation|Mean
2604550|NCT02119325|Secondary|AUC for Insulin in IFG Status Participants|To evaluate the effect of fibre rich health food drink on AUC for insulin in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||µIU*min/mL||Standard Deviation|Mean
2604618|NCT02118961|Secondary|Geometric Mean Titer Ratios of Anti-PT and Anti-FHA Antibodies|Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers|pre vaccination and 28-42 days after vaccination|The Outcome Measure was only pre-specified for the BK1301 Arm/Group.|||titer ratio||95% Confidence Interval|Geometric Mean
2604551|NCT02119325|Secondary|Cmax for Insulin in IFG Status Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for insulin in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||µIU/mL||Standard Deviation|Mean
2604552|NCT02119325|Secondary|Tmax for RLP Cholesterol in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on Tmax of RLP Cholesterol in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||minutes||Standard Deviation|Mean
2604553|NCT02119325|Secondary|AUC for RLP Cholesterol in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mmole*min/L||Standard Deviation|Mean
2604554|NCT02119325|Secondary|Cmax for RLP Cholesterol in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on post prandial RLP Cholesterol peak (Cmax) in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mmole/L||Standard Deviation|Mean
2604555|NCT02119325|Secondary|Tmax for RLP Cholesterol in IFG Status Participants|To evaluate the effect of fibre rich health food drink on Tmax for RLP Cholesterol in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||minutes||Standard Deviation|Mean
2604556|NCT02119325|Secondary|AUC for RLP Cholesterol in IFG Status Participants|To evaluate the effect of fibre rich health food drink on AUC for RLP Cholesterol in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mmole*min/L||Standard Deviation|Mean
2604557|NCT02119325|Secondary|Cmax for RLP Cholesterol in IFG Status Participants|To evaluate the effect of fibre rich health food drink on post prandial Remnant Lipoprotein Cholesterol (RLP Cholesterol) peak (Cmax) in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mmole/L||Standard Deviation|Mean
2604558|NCT02119325|Secondary|Tmax for Triglycerides in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on Tmax of triglycerides in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||minutes||Standard Deviation|Mean
2604559|NCT02119325|Secondary|AUC for Triglycerides in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for triglycerides in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mg*min/dL||Standard Deviation|Mean
2604560|NCT02119325|Secondary|Cmax for Triglyceride in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mg/dL||Standard Deviation|Mean
2604561|NCT02119325|Secondary|Tmax for Glucose in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on the time when maximum post prandial concentration is reached (Tmax) of blood glucose in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||minutes||Standard Deviation|Mean
2604619|NCT02118961|Secondary|Geometric Mean Titer Ratios of Anti-D and Anti-T Antibodies|Ratios were calculated as 28-42 days after vaccination titers over pre vaccination titers|pre vaccination and 28-42 days after vaccination||||titer ratio||95% Confidence Interval|Geometric Mean
2604562|NCT02119325|Secondary|AUC for Glucose in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on area under the curve (AUC) for glucose in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mg*min/dL||Standard Deviation|Mean
2604563|NCT02119325|Secondary|Cmax for Glucose in Overweight Healthy Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mg/dL||Standard Deviation|Mean
2604564|NCT02119325|Primary|Cmax for Triglyceride in IFG Status Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for triglyceride in healthy overweight adults with IFG|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mg/dL||Standard Deviation|Mean
2604565|NCT02119325|Primary|Cmax for Glucose in IFG Status Participants|To evaluate the effect of fibre rich health food drink on post prandial peak (Cmax) for glucose in healthy overweight adults with impaired fasting glucose (IFG)|Blood samples will be taken at -35, 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 & 240 minutes|The per protocol (PP) population was the primary population used for analysis. The PP population included all subjects that fulfil the study entry criteria, receive at least one of the study treatments, have enough plasma samples to estimate the efficacy parameters and are without a major protocol deviation.|||mg/dL||Standard Deviation|Mean
2604566|NCT02119299|Secondary|Device Compliance|Device compliance is calculated as 100*(# Device Uses Since Visit 5)/(# eating episodes since Visit 5).|Week 16||||% of eating episodes with device use||Standard Deviation|Mean
2604567|NCT02119299|Secondary|Percentage Total Body Loss and Treatment Compliance Correlation|The measured relationship between SMART device usage and total weight loss.|16 weeks|Per Protocol Population|||Pearson correlation|||Number
2604568|NCT02119299|Secondary|Proportion of Subjects Achieving ≥12% EWL||16 weeks|Per Protocol Population|||Participants|||Count of Participants
2604569|NCT02119299|Secondary|Proportion of Subjects Achieving ≥4% Weight Loss||16 weeks|Per Protocol Population|||Participants|||Count of Participants
2604570|NCT02119299|Secondary|Mean Absolute Weight Loss (kg)||16 weeks|Per Protocol Population|||Body weight (kg)||Standard Deviation|Mean
2604571|NCT02119299|Secondary|Mean Percentage Excess Weight Loss (EWL)||16 weeks|Per Protocol Population|||percentage of excess weight loss||Standard Deviation|Mean
2604572|NCT02119299|Primary|Mean %Total Body Weight Loss (TBL) at 16 Weeks Compared to Week 0||16 weeks|Per Protocol population|||% TBL||Standard Deviation|Mean
2604573|NCT02119299|Primary|Proportion of Subjects Achieving ≥5% Weight Loss at 16 Weeks Compared to Week 0||16 weeks|Per Protocol Population|||Participants|||Count of Participants
2604574|NCT02119286|Secondary|Change From Baseline in Weighted Mean (WM), 0-6 Hour FEV1 Obtained Post-dose at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The 0-6 hour weighted mean was derived by calculating the area under the FEV1/time curve over the nominal time points of 0 hour (trough value), 15 and 30 min, 1, 3 and 6 hours, using the trapezoidal rule, and then dividing by the actual time between dosing and the 6 hour assessment. Analysis was performed using MMRM with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, Day, and Day by Baseline and Day by treatment interactions. Baseline FEV1 is the mean of the two assessments made at 30 and 5 min pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value.|Day 84|ITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the ITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
2604575|NCT02119286|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84. Analysis was performed using a mixed model repeated measures (MMRM) with covariates of treatment, Baseline FEV1, smoking status, Day, treatment, Day by baseline interaction and Day by treatment interaction, Day being nominal. Baseline FEV1 is the mean of the two assessments made at 30 and 5 minutes (min) pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value.|Day 85|ITT Population: all pars. randomized to treatment who received ≥ 1 dose of randomized study medication in the Treatment Period. Number of pars. presented represent those with data available at given time point; however, all pars. in the ITT population without missing covariate information, with ≥ 1 post BL measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
2604576|NCT02119260|Secondary|Area Under the Concentration-time Curve From Pre-dose to 24 Hours Post-dose (AUC [0-24]) Following Single and Repeat Doses of GSK2798745 in Stable Heart Failure Participants|Blood samples for PK analysis were obtained at Day 1 and Day 7 of each treatment period for analysis of AUC (0-24). Log untransformed values for Cmax has been presented.|Day 1 and Day 7|Pharmacokinetic Population|||hour*ng/mL||Standard Deviation|Mean
2604577|NCT02119260|Secondary|Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of GSK2798745 in Stable Heart Failure Participants|Blood samples for PK analysis were obtained at Day 1 and Day 7 of each treatment period for analysis of Cmax. Log untransformed values for Cmax has been presented.|Day 1 and Day 7|Pharmacokinetic Population|||ng/mL||Standard Deviation|Mean
2604581|NCT02119260|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Stable Heart Failure Participants|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect, any other situation according to medical or scientific judgment, or is associated with liver injury and impaired liver function will be categorized as SAE.|Up to 17 weeks|All Subjects Population|||Participants|||Number
2604582|NCT02119260|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) in Healthy Participants|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect, any other situation according to medical or scientific judgment, or is associated with liver injury and impaired liver function will be categorized as SAE.|Up to 17 weeks|All Subjects Population|||Participants|||Number
2604583|NCT02119260|Primary|Number of Participants With Abnormal Routine Urinalysis in Stable Heart Failure Participants|Urine samples were collected to analyze specific gravity, determining potential of hydrogen (pH), glucose, protein, blood, and ketones by dipstick method, and microscopic examination (if blood or protein is abnormal). The number of participants with abnormal urinalysis data have been presented.|Up to 17 weeks|All Subjects Population|||Participants|||Number
2604584|NCT02119260|Primary|Number of Participants With Abnormal Routine Urinalysis in Healthy Participants|Urine samples were collected to analyze specific gravity, determining potential of hydrogen (pH), glucose, protein, blood, and ketones by dipstick method, and microscopic examination (if blood or protein is abnormal). The number of participants with abnormal urinalysis data have been presented.|Up to 17 weeks|All Subjects Population|||Participants|||Number
2604585|NCT02119260|Primary|Number of Participants With Hematology Parameter Laboratory Values of Potential Clinical Concern in Stable Heart Failure Participants|Blood samples were collected from participants to evaluate hematology parameters of potential clinical concern. Hematology parameters included platelet count, red blood cells count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, neutrophils, white blood cells count, lymphocytes, reticulocyte count, monocytes, hemoglobin, eosinophil, hematocrit, and basophiles. The number of participants with hematology values of potential clinical concern have been presented.|Up to 17 weeks|All Subjects Population|||Participants|||Number
2604586|NCT02119260|Primary|Number of Participants With Hematology Parameter Laboratory Values of Potential Clinical Concern in Healthy Participants|Blood samples were collected from participants to evaluate hematology parameters of potential clinical concern. Hematology parameters included platelet count, red blood cells count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, neutrophils, white blood cells count, lymphocytes, reticulocyte count, monocytes, hemoglobin, eosinophil, hematocrit, and basophiles. The number of participants with hematology values of potential clinical concern have been presented.|Up to 17 weeks|All subjects population|||Participants|||Number
2604587|NCT02119260|Primary|Number of Participants With Clinical Chemistry Laboratory Values of Potential Clinical Concern in Stable Heart Failure Participants|Blood samples were collected from participants to evaluate clinical parameters of potential clinical concern. Clinical parameters included blood urea nitrogen, potassium, total and direct bilirubin, creatinine chloride, alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase, alkaline phosphatase, uric acid, glucose, fasting troponin, albumin, sodium calcium total protein, and creatine phosphokinase. The number of participants with clinical chemistry values of potential clinical concern have been presented.|Up to 17 weeks|All Subjects Population|||Participants|||Number
2604588|NCT02119260|Primary|Number of Participants With Clinical Chemistry Laboratory Values of Potential Clinical Concern in Healthy Participants|Blood samples were collected from participants to evaluate clinical parameters of potential clinical concern. Clinical parameters included blood urea nitrogen, potassium, total and direct bilirubin, creatinine chloride, alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase, alkaline phosphatase, uric acid, glucose, fasting troponin, albumin, sodium calcium total protein, and creatine phosphokinase. The number of participants with clinical chemistry values of potential clinical concern have been presented.|Up to 17 weeks|All Subjects Population|||Participants|||Number
2604589|NCT02119260|Primary|Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern in Stable Heart Failure Participants|ECGs will be obtained in the semi-supine position after at least 5 minutes. The potential clinical concern range for ECG parameters are: QRS interval: >200 milliseconds (msec); time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Bazett's formula (QTcB):>500msec; time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTcF interval): >500 msec; PR interval:>300msec. The number of participants with ECG values of potential clinical concern have been presented.|Up to 17 weeks|All Subjects Population|||Participants|||Number
2604590|NCT02119260|Primary|Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern in Healthy Participants|ECGs will be obtained in the semi-supine position after at least 5 minutes. The potential clinical concern range for ECG parameters are: QRS interval: >200 milliseconds (msec); time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Bazett's formula (QTcB):>500msec; time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTcF interval): >500 msec; PR interval:>300msec. The number of participants with ECG values of potential clinical concern have been presented.|Up to 17 weeks|All Subjects Population|||Participants|||Number
2604620|NCT02118961|Secondary|Geometric Mean Titers (GMTs) of Anti-PT and Anti-FHA Antibodies||28-42 days after vaccination|The Outcome Measure was only pre-specified for the BK1301 Arm/Group.|||EU/mL||95% Confidence Interval|Geometric Mean
2604621|NCT02118961|Secondary|Geometric Mean Titers (GMTs) of Anti-D and Anti-T Antibodies||28-42 days after vaccination||||IU/mL||95% Confidence Interval|Geometric Mean
2604591|NCT02119260|Primary|Number of Participants With Vital Sign Values of Potential Clinical Concern in Stable Heart Failure Participants|Vital signs included seated supine systolic blood pressure (SBP) and diastolic blood pressure (DBP), heart rate (HR), and respiratory rate (RR). Vital signs criteria of potential clinical concern were SBP: <100 and >170 millimeters of mercury (mmHg); DBP: <50 and >110 mmHg and HR: <50 and >120 beats per minute (bpm). Only those parameters for which at least one value of potential clinical concern was reported are summarized. All Subjects Population includes any participant enrolled into the study who received at least one dose of study medication within a cohort|Up to 17 weeks|All Subjects Population|||Participants|||Number
2604592|NCT02119260|Primary|Number of Participants With Vital Sign Values of Potential Clinical Concern in Healthy Participants|Vital signs included seated supine systolic blood pressure (SBP) and diastolic blood pressure (DBP), heart rate (HR), and respiratory rate (RR). Vital signs criteria of potential clinical concern were SBP: <100 and >170 millimeters of mercury (mmHg); DBP: <50 and >110 mmHg and HR: <50 and >120 beats per minute (bpm). Only those parameters for which at least one value of potential clinical concern was reported are summarized. All Subjects Population includes any participant enrolled into the study who received at least one dose of study medication within a cohort|Up to 17 Weeks|All Subjects Population|||Participants|||Number
2604593|NCT02119156|Secondary|Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Decreased by 25 Percent From Day 0 of This Study|All corticosteroids are converted to a prednisone equivalent average daily dose (mg/day). The average daily dose at Day 0 was used to assess the relative change in daily dose on a given day. The average daily dose at Day 0 was calculated as sum of the daily dose across all days from the Screening visit date up to and including Day 0 visit date divided by the number of days in the time period. Data reported are the median number of days on which the specified criteria was met for Day 0 to Week 24, Week 24 to Week 52, Day 0 to Week 52. For treatment holiday group, Day 0 to Week 24 corresponds to holiday phase, Week 24 to Week 52 corresponds to treatment Re-start phase.|Day 0 to Week 24; Week 24 to Week 52; Day 0 to Week 52|ITT Population. Only those participants who met specified criteria (<=7.5 mg/day and/or decreased by 25%) within specified time period were analyzed (represented by n= X in the category titles).|||Days||Full Range|Median
2604594|NCT02119156|Secondary|Number of Days of Daily Prednisone Dose >=7.5 mg/Day and/or Increased by 25 Percent From Day 0 of This Study|All corticosteroids are converted to a prednisone equivalent average daily dose (mg/day). The average daily dose at Day 0 was used to assess the relative change in daily dose on a given day. The average daily dose at Day 0 was calculated as sum of the daily dose across all days from the Screening visit date up to and including Day 0 visit date divided by the number of days in the time period. Data reported are the median number of days on which the specified criteria was met for Day 0 to Week 24, Week 24 to Week 52, Day 0 to Week 52. For treatment holiday group, Day 0 to Week 24 corresponds to holiday phase, Week 24 to Week 52 corresponds to treatment Re-start phase.|Day 0 to Week 24; Week 24 to Week 52; Day 0 to Week 52|ITT Population. Only those participants who met specified criteria (>=7.5 mg/day and/or increased by 25%) within specified time period were analyzed (represented by n= X in the category titles).|||Days||Full Range|Median
2604595|NCT02119156|Secondary|SELENA SLEDAI Scores Change From Baseline|SELENA SLEDAI assessments consist of 24 individual weighted items in which signs and symptoms, laboratory tests, and physician's assessment for each of 9 organ systems are given a weighted score and summed if present (marked 'Yes') at the time of the visit or in the preceding 10 days. The maximum theoretical score is 105 (all 24 descriptors present simultaneously) with 0 indicating inactive disease (marked 'No'). Data are reported at the specified time-points from Day 0 (of present study) up to Week 52. Baseline is defined as the Day 0 from parent studies. Change from Baseline is equal to (Value at specified visit minus Baseline value).|Baseline (Day 0 from parent studies); Day 0 and 4, 8, 12, 16, 20, 24, 28, 32,36, 40, 44, 48 and 52 weeks|ITT Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2604596|NCT02119156|Secondary|Percentage Change From 24 Week in B Cell Subsets: Treatment Holiday Group (Re-start Phase)|Blood samples were collected at indicated time-points for analysis of Activated B cells subsets like Activated CD19+CD20+CD69+, CD20+, Memory CD19+CD20+CD27+, Naive CD19+CD20+CD27-, Plasma CD19+CD20-CD138+, Plasmacytoid CD19+CD20+CD138+, and SLE Subset CD19+CD38b+CD27b+Lymph. Percentage change from Week 24 of present study was calculated as 100*(value at specified visit - Week 24 value) divided by week 24 value. The data below is only reported for the Treatment Holiday Group (Re-start phase). Participants in this group restarted belimumab therapy one day after Week 24, hence the Baseline for this outcome measure was Week 24 visit. No other groups were measured for this outcome.|Week 24, 32, 40 and 52 weeks|ITT Population. Participants in this group restarted belimumab therapy one day after Week 24, hence the Baseline for this outcome measure was Week 24 visit. The data below is only reported for the Treatment Holiday Group and no other groups were measured.|||Percent change||Inter-Quartile Range|Median
2604597|NCT02119156|Secondary|Percentage Change From Baseline in B Cell Subsets|Blood samples were collected at indicated time-points for analysis of Activated B cells subsets like Activated CD19+CD20+CD69+, cluster of differentiation 20+ (CD20+), Memory CD19+CD20+CD27+, Naive CD19+CD20+CD27-, Plasma CD19+CD20-CD138+, Plasmacytoid CD19+CD20+CD138+, and SLE Subset CD19+CD38b+CD27b+Lymph. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100* (Value at specified visit minus Baseline value) divided by Baseline value.|Baseline (Day 0 from parent studies); Day 0 and 8, 16, 24, 32, 40 and 52 weeks|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent change||Inter-Quartile Range|Median
2604598|NCT02119156|Secondary|Percentage Change From Baseline in Complement Levels|Blood samples were collected at indicated time-points for analysis of complement levels like complement 3 (C3) and complement 4 (C4). Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100* (Value at specified visit minus Baseline value) divided by Baseline value.|Baseline (Day 0 from parent studies); Day 0 and 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 weeks|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent change||Inter-Quartile Range|Median
2604622|NCT02118961|Secondary|Percentage of Participants With Anti-PT and Anti-FHA Antibody Titers Above Protocol Defined Cut-off Values|Protocol defined cut-off values were 10 EU/mL.|28-42 days after vaccination|The Outcome Measure was only pre-specified for the BK1301 Arm/Group.|||percentage of Participants||95% Confidence Interval|Number
2604599|NCT02119156|Secondary|Percentage Change From Baseline in Autoantibody: Antinuclear Antibody (ANA)|Blood samples were collected at indicated time-points for analysis of autoantibodies like ANA. Only participants who had an ANA value measured in INDEX at the parent studies Baseline were included in this analysis. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100* (Value at specified visit minus Baseline value) divided by Baseline value.|Baseline (Day 0 from parent studies); Day 0 and 24 and 52 weeks|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent change||Inter-Quartile Range|Median
2604600|NCT02119156|Secondary|Percentage Change From Baseline in Autoantibody:Anti-double Stranded Deoxyribonucleic Acid (dsDNA)|Blood samples were collected at indicated time-points for analysis of autoantibodies like dsDNA. Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100* (Value at specified visit minus Baseline value) divided by Baseline value.|Baseline (Day 0 from parent studies); Day 0 and 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 weeks|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent change||Inter-Quartile Range|Median
2604601|NCT02119156|Secondary|Percentage Change From Baseline in Immunoglobulin|Serum samples were collected at indicated time-points for analysis of immunoglobulins: Immunoglobulin G (IgG), Immunoglobulin A (IgA), and Immunoglobulin M (IgM). Baseline is defined as the Day 0 visit from parent studies. Percentage change from Baseline is equal to 100* (value at specified visit minus Baseline value) divided by Baseline value.|Baseline (Day 0 from parent studies); Day 0 and 8, 16, 24, 32, 40, 48 and 52 weeks|ITT Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent change||Inter-Quartile Range|Median
2604602|NCT02119156|Secondary|Number of Participants With Confirmed True Positive Belimumab Anti-drug Antibodies (ADA)|Immunogenicity assay results were categorized as negative or positive. A persistent positive result was defined as a positive post-Day 0 visit immunogenic response that occurred for at least 2 consecutive assessments or a single result at the final assessment. A transient positive result was defined as a single post-Day 0 visit positive immunogenic response that did not occur at the final assessment. Any time post-Day 0 visit data are reported (or post-Week 24 for Treatment Holiday - Restart phase). Day 0 visit date is defined as Day 0 from present study.|Up to 52 weeks|ITT Population.|||Participants|||Count of Participants
2604603|NCT02119156|Secondary|Number of Participants With Evidence of Rebound|Rebound is defined as SELENA SLEDAI score during the first 24 weeks that exceeds the Baseline SELENA SLEDAI score in the participant's respective original parent study. Baseline is defined as the Day 0 visit from the parent study. SELENA SLEDAI assessments consist of 24 individual weighted items in which signs and symptoms, laboratory tests, and physician's assessment for each of 9 organ systems are given a weighted score and summed if present (marked 'Yes') at the time of the visit or in the preceding 10 days. The maximum theoretical score is 105 (all 24 descriptors present simultaneously) with 0 indicating inactive disease (marked 'No'). Any time during the first 24 weeks of this study has been reported.|Up to 24 weeks|ITT Population.|||Participants|||Count of Participants
2604604|NCT02119156|Secondary|Median Time to First Severe SFI Flare|"The SLE Flare Index categorizes SLE flare as mild or moderate or severe based on a positive assessment for at least 1 of 5 variables as follows: Change in SELENA SLEDAI score from the most recent assessment to current; Change in signs or symptoms of disease activity; Change in prednisone dosage; Use of new medications for disease activity or hospitalization; Change in Physician's Global Assessment (PGA) score; Hospitalization for SLE activity is an additional category included only for a severe flare. Time to first severe flare is defined as (event date-Day 0 visit date) + 1 for Long-term discontinuation, treatment control groups and holiday phase group. For holiday phase group data censored at last flare assessment by treatment re-start date. Time to first severe flare is defined as (event date-treatment re-start date) + 1 for Re-start treatment holiday group. Median time to first severe SFI flare is reported; estimated using the product-limit method."|Up to 52 weeks|ITT Population.|||Days||Inter-Quartile Range|Median
2604605|NCT02119156|Secondary|Rate of SLE Index Flare Per Subject Year|Rate per subject year of SFI flare was calculated as total number of flares divided by total subject years in interval. The total subject years for each participant was calculated as (Week 52/ Exit visit date minus Day 0 visit date + 1) for Long-term discontinuation and treatment control groups. For treatment holiday phase group the subject-years for each participant was calculated as (Week 24/Treatment Re-start/Exit visit date minus Day 0 Visit date + 1)/365.25. For re-start treatment holiday phase group the subject-years for each participant was calculated as (Week 52/Exit visit date minus Week 24/Treatment Re-start date + 1)/365.25. Day 0 visit date is defined as Day 0 from present study.|Up to 52 weeks|ITT Population|||Flares per Subject-year|||Number
2604606|NCT02119156|Primary|Median Time to First SLE Flare Index (SFI)|SFI Flare was defined as a mild/moderate or severe flare according to the modified Safety of Estrogen in Lupus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) SLE Flare Index (modified excluded severe flares from the SELENA SLEDAI flare assessment that were triggered only by an increase in SELENA SLEDAI score to >12).Time to first SFI flare is defined as the number of days from Day 0 visit date to the date the participant has a flare (event date - Day 0 visit date + 1) in the 52 Week/Holiday phase; (event date - treatment re-start date + 1) in the Re-start Holiday phase. Day 0 visit date is defined as Day 0 from present study. Median time to first SFI flare is reported; estimated using the product-limit method.|Up to 52 weeks|Intent-to-Treat (ITT) Population comprised of all participants who enrolled in the study, excluding screen failures.|||Days||Inter-Quartile Range|Median
2604607|NCT02119104|Primary|Number of Participants With Adverse Reactions|An adverse reaction (vaccine-related adverse event) was any untoward medical occurrence which was considered to be related to Prevenar 13 in a participant who received Prevenar 13.|The entire observation period was from Day 1 of the 1st vaccination through Day 28 of the 4th vaccination.|The safety analysis population comprised of participants who had received Prevenar 13 at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||Participants|||Number
2604623|NCT02118961|Secondary|Percentage of Participants With Anti-D and Anti-T Antibody Titers Above Protocol Defined Cut-off Values|Protocol defined cut-off values were 0.1 IU/mL for anti-D and 0.01 IU/mL for anti-T.|28-42 days after vaccination||||percentage of Participants||95% Confidence Interval|Number
2604608|NCT02119026|Secondary|Tumour Assessments (Based on RECIST Criteria) in 2nd-line|Best response in second line was based on the tumor assessments (based on RECIST criteria) for target lesions and assessed by CT scans, MRI scans, X-ray, bone scan and clinical examination: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (sum LD) of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the LD of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline, every 8-9 weeks, 28d Safety follow-up||||participants|||Number
2604609|NCT02119026|Secondary|Tumour Assessments (Based on RECIST Criteria) in 1st-line|Best response in first line was based on the tumor assessments (based on RECIST criteria) for target lesions and assessed by CT scans, MRI scans, X-ray, bone scan and clinical examination: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter (sum LD) of target lesions; Progressive Disease (PD), >= 20% increase in the sum of the LD of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline, every 8-9 weeks, 28d Safety follow-up||||participants|||Number
2604610|NCT02119026|Secondary|Overall Survival of XELIRI Plus Bevacizumab and XELOX Plus Bevacizumab|Overall survival was measured as the time from the randomization date to the date of death. Patients without death date were censored at the date of the last tumor assessment (exception: availability of validated information about a later exitus date or a prolonged survival - in such a case the date of the follow-up assessment was either defined as the exitus date or replaced the last tumor assessment date) or the date of refusal.|date of death or date of last tumor assessment (28d safety f-u) in patients without death|ITT-Population|||days||95% Confidence Interval|Median
2604611|NCT02119026|Secondary|Duration of Response|"Duration of overall response was measured from the time that measurement criteria are met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the onset of progression. Patients without progression at the last tumor assessment date during their study participation were censored at this last tumor assessment date (exception: availability of validated information about a later onset of progression or a longer progression free interval - in such a case the date of the follow-up assessment was either defined as the onset of progression or replaced the last tumor assessment date).~Missing onset of progression data because of refusal or because of death was replaced.~If several response evaluations for a patient showed progressive disease (PD), the time to PD was assessed by using the first of these measurements."|at the day of documented complete or partial response or at 28 days safety follow-up in cases without PD||||days||95% Confidence Interval|Median
2604612|NCT02119026|Secondary|Time to Response|Time to overall response was measured from the time of randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first). Patients without response were censored at the date of the last tumor assessment, the date of death or the date of refusal.|at the day of documented complete or partial response or at 28 days safety follow-up in cases without PD|ITT-Population|||days||95% Confidence Interval|Median
2604613|NCT02119026|Secondary|Overall Response Rate (Number of Participants With Response)|The rate of overall response was measured as the response rate from randomization until the day of documented complete response (CR) or partial response (PR) (whichever status is recorded first).|at the day of documented complete or partial response or at 28 days safety follow-up in cases without PD|ITT-Population|||Participants|||Count of Participants
2604614|NCT02119026|Secondary|Second Line PFS|"The second line PFS was defined as the progression free survival interval during second line treatment. Patients without progression at the last tumor assessment date during their study participation were censored at this last tumor assessment date (exception: availability of validated information about a later onset of progression or a longer progression free interval - in such a case the date of the follow-up assessment was either defined as the onset of progression or replaced the last tumor assessment date). Missing onset of progression data because of refusal or because of death was replaced.~If several response evaluations for a patient showed progressive disease (PD), the time to PD was assessed by using the first of these measurements."|at progression of disease (PD) in second line therapy or at 28 days safety follow-up in cases without PD|ITT-Population after cross-over|||days||95% Confidence Interval|Median
2604615|NCT02119026|Secondary|First Line Progression Free Survival (PFS)|The first line PFS was defined as the progression free survival interval during first line treatment. Patients without progression at the last tumor assessment date during their study participation were censored at this last tumor assessment date (exception: availability of validated information about a later onset of progression or a longer progression free interval - in such a case the date of the follow-up assessment was either defined as the onset of progression or replaced the last tumor assessment date). Missing onset of progression data because of refusal or because of death was replaced. If several response evaluations for a patient showed progressive disease (PD), the time to PD was assessed by using the first of these measurements.|at progression of disease (PD) in first line therapy or at 28 days safety follow-up in cases without PD|ITT-Population|||days||95% Confidence Interval|Median
2604616|NCT02119026|Primary|Efficacy Duration of Disease Control by Tumor Assessment (CT/MRI/Clinical Examination)|The primary variable was duration of disease control (DDC) and was defined as the sum of progression free survival intervals during first line and second line treatment (= time from the beginning of first line treatment until onset of progression during second line treatment). Patients without progression at the last tumor assessment date during their study participation were censored at this last tumor assessment date (exception: availability of validated information about a later onset of progression or a longer progression free interval - in such a case the date of the follow-up assessment was either defined as the onset of progression or replaced the last tumor assessment date).|screening, every 8 to 9 weeks until progression, at end of treatment (other than progression), every 3 months until progression, death or up to 24 months (whatever comes first)|ITT-Population|||days||95% Confidence Interval|Median
2604617|NCT02118961|Secondary|Percentage of Participants With Adverse Events||28-42 days following vaccination||||percentage of participants|||Number
2605577|NCT02108171|Other Pre-specified|Time to Consciousness of Patients Receiving Intranasal Placebo|Time to consciousness of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and consciousness.|1 day||||minutes|||Number
2604624|NCT02118961|Primary|Percentage of Participants With Booster Responses for Anti-pertussis Toxoid (Anti-PT) and Anti-Filamentous Hemagglutinin (Anti-FHA) Antibodies|Booster response was defined as post titer ≥ 20 EU/mL and post/pre titer ≥ 4 increase in a subject with pre titer < 20 EU/mL, or post/pre titer ≥ 2 increase in a subject with pre titer ≥ 20 EU/mL.|pre-vaccination and 28-42 days after vaccination|The Outcome Measure was only pre-specified for the BK1301 Arm/Group.|||percentage of Participants||95% Confidence Interval|Number
2604625|NCT02118961|Primary|Percentage of Participants With Booster Responses for Anti-diphtheria Toxoid (Anti-D) and Anti-tetanus Toxoid (Anti-T) Antibodies|Booster response was defined as post titer ≥ 0.4 IU/mL and post/pre titer ≥ 4 increase.|pre-vaccination and 28-42 days after vaccination||||percentage of Participants||95% Confidence Interval|Number
2604626|NCT02118896|Post-Hoc|Efficacy Failure|Efficacy failure was defined as BCAR, graft loss, death, or an unknown outcome at the end of the study period. Start, event and censor times for the Kaplan-Meier analyses of efficacy failure were (Event time: onset of first episode of BCAR, graft loss, or death after study start, Censor Time: day of withdrawal (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study). No Kaplan-Meier estimates for PMR-EC-1210 due to the short subject participation period and the low number of subjects|Up to 5.75 years ((69 months (phase II) and 33 months (phase III)).|The study analysis population for this endpoint consisted of participants with efficacy failure.|||participants with efficacy failure|||Number
2604627|NCT02118896|Secondary|Number of Participants With Adverse Events|An AE was defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have a causal relationship with treatment. An AE was, therefore, any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use the study drug, whether or not related to the study drug. Causally-related is defined as a highly probably, probably, possible, not assessable or missing relationship as assessed by the investigator. An SAE was any untoward medical occurrence that at any dose: Resulted in death, was life threatening: did not refer to event which hypothetically might have caused death if more severe); resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect; required inpatient hospitalization/led to prolongation of hospitalization (treatment/observation/examination caused by AE was considered serious); other medically important events.|From first dose to duration of participation in the study (up to 6 years and 28 days after EOS).|FAS population.|||participants with adverse events|||Number
2604628|NCT02118896|Secondary|Time to First BCAR Episode|The time to first acute rejection episode was defined as the number of days from day 1 (defined as the day of study enrollment) to the first clinical, laboratory or histological signs that were considered to be related to the first acute rejection episode.|Up to 1344 days (3.75 years).|The study analysis population for this endpoint consisted of subjects with biopsy confimed acute rejection.|||days||Standard Deviation|Mean
2604629|NCT02118896|Secondary|Biopsy-confirmed Acute Rejection (BCAR) Episodes|"FAS population. Evaluation of biopsy specimens performed by local histopathologist following Histological Grading of Biopsies for Rejection using grading relevant to type of organ allograft. Spontaneously resolving AR defined as episode not treated with new/increased corticosteroid medication, antibodies/any other medication and resolved irrespective of any MR4/MMF/azathioprine dose changes; corticosteroid sensitive AR was an episode which was treated with new/increased corticosteroid medication only and resolved, irrespective of any MR4, MMF or azathioprine dose changes; corticosteroid resistant AR was an episode which did not resolve following treatment with corticosteroids, if it was not treated with corticosteroids first but only with antibodies, it was included in this category; corticosteroid resistant AR episodes were further classified into episodes which resolved with further treatment and those which did not respond to further treatment/were ongoing at EOS/withdrawal."|Up to 6 years.|FAS population.|||participants with with BCAR episodes|||Number
2604630|NCT02118896|Primary|Graft Survival|Graft survival was analyzed using Kaplan-Meier Method procedures at 66 months (phase II) and 30 months (phase III). The two-sided 95% confidence intervals for the estimated rates of patients free from graft loss at EOS was calculated using Greenwood's formula. Graft loss was defined as re-transplantation or death. For kidney transplantation graft loss was also defined as nephrectomy or return to long-term dialysis. The date of graft loss is the earliest date of either of these events. Start, event and censor times for the Kaplan-Meier analyses of graft survival were (Event time: day of death, Censor Time: day of last follow-up (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study) .|Up to 5.5 years ((66 months (phase II) and 30 months (phase III)).|Study analysis population for this primary endpoint consisted of the FAS.|||survival probability||95% Confidence Interval|Number
2604631|NCT02118896|Primary|Participant Survival|Participant survival was analyzed using Kaplan-Meier (KM) method procedures at 66 months (phase 2) and 24 months (phase III). The two-sided 95% confidence intervals (CI) for the estimated rates of patients alive at end of study (EOS) was calculated using Greenwood's formula. Start, event and censor times for the Kaplan-Meier analyses of participant survival were (Event time: day of death, Censor Time: day of last follow-up (for participants prematurely withdrawn from the study), and day of last visit (for participants completing the study) .|Up to 5.5 years (66 months (phase II) and 24 months (phase III)).|The population for analysis was the Full Analysis Set (FAS) which included all subjects who received at least one dose of study drug, MR4, while participating in one of the phase II Pharmacokinetics (PK) or phase III studies and at least one dose of MR4 during this study.|||survival probability||95% Confidence Interval|Number
2604632|NCT02118831|Secondary|Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment)|Minimum serum levels of free vascular endothelial growth factor will be measured at baseline and at 4 months following treatment (one month after last treatment).|baseline and month 4||||pg/mL||95% Confidence Interval|Mean
2604633|NCT02118831|Primary|Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses|Maximum serum levels of ranibizumab, bevacizumab or aflibercept will be measured after the first and third injections, up to 28 days following each treatment.|Up to 4 months||||nM||Standard Deviation|Mean
2604824|NCT02116660|Secondary|Percentage of Participants With Suppressed Viremia (<50 Copies/mL HIV-1 RNA) at Week 96|Plasma was to be collected at Week 96 in order to quantify HIV-1 RNA. and identify the percentage of participants with <50 copies/mL HIV-1 RNA.|Week 96|Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed.||||||
2604634|NCT02118792|Primary|Percentage of Participants With Local Tolerability Symptoms at Day 36|Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale which ranges from 0 to 3, where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicate high severity of symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.|Day 36|"Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, N signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2604635|NCT02118792|Primary|Percentage of Participants With Local Tolerability Symptoms at Day 29|Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale which ranges from 0 to 3, where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicate high severity of symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.|Day 29|"Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, N signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2604636|NCT02118792|Primary|Percentage of Participants With Local Tolerability Symptoms at Day 22|Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale which ranges from 0 to 3, where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicate high severity of symptoms. In this outcome, percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.|Day 22|"Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, number of participants analyzed N signifies those participants who were analyzed in this outcome measure."|||percentage of participants|||Number
2604637|NCT02118792|Primary|Percentage of Participants With Local Tolerability Symptoms at Day 15|Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale ranging from 0 to 3, where 0= none (no stinging/burning), 1= mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicated more severe symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.|Day 15|"Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, N signifies those participants who were analyzed in this outcome measure."|||percentage of participants|||Number
2604638|NCT02118792|Primary|Percentage of Participants With Local Tolerability Symptoms at Day 8|Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale ranging from 0 to 3, where 0= none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicated more severe symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.|Day 8|"Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, N signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2604639|NCT02118792|Other Pre-specified|Change From Baseline in Dermatitis Family Impact Questionnaire (DFI) Score at Day 29|The DFI was a 10-item disease questionnaire that measures the impact of having a child with AD on family quality of life. It was completed by parent/legal guardian of the child (affected by AD), based on recall over the past week. Each question was scored on a 4-point scale ranging from 0 (good) to 3 (worst), where higher scores indicated worst quality of life of family. The DFI total score was the sum of individual scores of the 10 questions and ranges from 0 (good) to 30 (worst), where higher DFI scores indicated worst quality of life of family.|Baseline (Day 1), Day 29|ITT population included all participants who were randomized and received study drug. Here, ''N'' signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2604640|NCT02118792|Other Pre-specified|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Day 29|The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.|Baseline (Day 1), Day 29|ITT population included all participants who were randomized and received study drug. Here, ''N'' signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2604658|NCT02118766|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 29|Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, respiratory rate and body temperature. Vital sign measurements were performed with the participant in the seated or supine position. Clinical significance of change from baseline value was determined by investigator.|Baseline, Day 29|Safety population included all randomized participants who received at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.|||participants|||Number
2604641|NCT02118792|Other Pre-specified|Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Day 29|The CDLQI was a 10-item questionnaire that measures the impact of skin disease on children's (aged 2-15 years) quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the children's life; 2-6 = small effect on the children's life; 7-12 = moderate effect on the children's life; 13-18 = very large effect on the children's life; 19-30 = extremely large effect on the children's life. Higher scores indicate more impact on quality of life of children.|Baseline (Day 1), Day 29|ITT population included all participants who were randomized and received study drug. Here, Number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2604642|NCT02118792|Other Pre-specified|Time to Improvement in Pruritus|Time to improvement in pruritus was defined as the time interval between the administration of first dose of study drug till the first documentation of improvement in pruritus. Improvement in pruritus was defined as achieving none (0) or mild (1) score with at least a 1- grade improvement from baseline. Severity of pruritus was assessed on 4-point numeric scale ranges from 0 to 3, where 0= none (no itching), 1= mild (occasional, slight itching/scratching), 2= moderate (constant or intermittent itching/scratching which is not disturbing sleep) and 3= severe (bothersome itching/scratching which is disturbing sleep). Higher scores indicated more severe condition. It was analyzed using Kaplan-Meier method.|Baseline (Day 1) up to Day 29|"ITT population included all participants who were randomized and received study drug. Here, N'' signifies those participants who were evaluable for this outcome measure."|||days||95% Confidence Interval|Median
2604643|NCT02118792|Secondary|Change From Baseline in Signs of Atopic Dermatitis at Day 29|Signs of AD included erythema, induration/papulation, exudation, excoriation and lichenification. Each sign was assessed on a 4- point scale ranges from 0 to 3, where 0= none, 1= mild, 2= moderate to 3= severe. Higher score indicates severe signs and symptoms of AD.|Baseline, Day 29|ITT population included all participants who were randomized and received study drug. Here, 'n' signifies those participants who were evaluable at specific time point for each arm.|||units on a scale||Standard Deviation|Mean
2604644|NCT02118792|Secondary|Time to Achieve Treatment Success Based on Investigator's Static Global Assessment (ISGA)|Time to achieve treatment success based on ISGA was defined as the time interval between the administrations of first dose of study drug until first documentation of success in ISGA. Success in ISGA was defined as an ISGA score of clear (0) or almost clear (1) with at least 2-grade improvement from baseline. It was analyzed using Kaplan-Meier method.|Baseline up to Day 29|ITT population included all participants who were randomized and received study drug.|||days||95% Confidence Interval|Median
2604645|NCT02118792|Secondary|Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Day 29|ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Percentage of participants with an ISGA score of 0 or 1 were reported.|Day 29|ITT population included all participants who were randomized and received study drug.|||percentage of participants|||Number
2604646|NCT02118792|Primary|Percentage of Participants With Local Tolerability Symptoms at Baseline|Local tolerability symptoms (burning/stinging) were assessed in participants at sites of study drug application. Symptoms were assessed on 4-point scale ranging from 0 to 3, where 0 = none (no stinging/burning), 1 = mild (slight warm, tingling sensation); 2= moderate (definite warm; tingling/stinging sensation that is somewhat bothersome and severe); 3= severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores indicated more severe symptoms. Percentage of participants with each level of local tolerability (none, mild, moderate, severe) symptoms were reported.|Baseline (Day 1)|Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2604647|NCT02118792|Primary|Number of Participants With Clinically Significant Laboratory Values|Laboratory values included: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Bilirubin, Blood Urea Nitrogen, Glucose, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets, Basophils, Eosinophils, Erythrocytes, Potassium, Protein, Sodium. Clinically significant laboratory abnormalities were defined as abnormal laboratory test values that have clinical manifestations or require medical intervention, as per investigator's discretion.|Baseline up to Day 36|Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.|||participants|||Number
2604648|NCT02118792|Primary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Day 36|Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, pulse, respiratory rate and body temperature. Vital sign measurements were performed with the participant in the seated or supine position and after the participant had been calmly sitting or lying face up for a minimum of 5 minutes. Clinical significance of change from baseline value was determined by investigator.|Baseline (Day 1), Day 36|Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.|||participants|||Number
2604649|NCT02118792|Primary|Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings at Day 8|ECG parameters that were analyzed: PR interval, QRS interval, QT interval and corrected QT interval based on Fridericia's formula (QTcF). Clinical significance of change from baseline in ECG findings was determined by investigator.|Baseline, Day 8|Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.|||participants|||Number
2604650|NCT02118792|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study, that were absent before treatment or that worsened relative to pre-treatment state.|AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36|Safety population included all randomized participants who had at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.|||participants|||Number
2604651|NCT02118792|Primary|Percentage of Participants Who Achieved Success in Investigator's Static Global Assessment (ISGA) Score at Day 29|ISGA assessed the severity of AD (except scalp) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual hypo/hyper pigmentation, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Treatment success was defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement from baseline.|Day 29|ITT population included all participants who were randomized and received study drug.|||percentage of participants|||Number
2604652|NCT02118766|Other Pre-specified|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Day 29|The DLQI was a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.|Baseline, Day 29|Intent to treat population included all participants who were randomized and dispensed study drug. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2604653|NCT02118766|Other Pre-specified|Time to Improvement in Pruritus|Time to improvement in pruritus was defined as the time interval between the administration of first dose of study drug till the first documentation of improvement in pruritus. Improvement in pruritus was defined as achieving none (0) or mild (1) score with at least a 1- grade improvement from baseline. Severity of pruritus was assessed on 4-point numeric scale ranges from 0 to 3, where 0= none (no itching), 1= mild (occasional, slight itching/scratching), 2= moderate (constant or intermittent itching/scratching which is not disturbing sleep) and 3= severe (bothersome itching/scratching which is disturbing sleep). Higher scores indicated more severe condition. It was analyzed using Kaplan-Meier method.|Baseline up to Day 29|Intent to treat population included all participants who were randomized and dispensed study drug. Here, 'N' signifies those participants who were evaluable for this measure.|||days||95% Confidence Interval|Median
2604654|NCT02118766|Secondary|Change From Baseline in Signs of Atopic Dermatitis (AD) at Day 29|Signs of AD included erythema, induration/papulation, exudation, excoriation and lichenification. Each sign was assessed on a 4- point scale ranges from 0 to 3, where 0= none, 1= mild, 2= moderate to 3= severe. Higher score indicates severe signs and symptoms of AD.|Baseline, Day 29|Intent to treat population included all participants who were randomized and dispensed study drug. Here, Number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2604655|NCT02118766|Secondary|Time to Achieve Treatment Success Based on Investigator's Static Global Assessment (ISGA)|Time to achieve treatment success based on ISGA was defined as the time interval between the administrations of first dose of study drug until first documentation of success in ISGA. Success in ISGA was defined as an ISGA score of clear (0) or almost clear (1) with at least 2-grade improvement from baseline. It was analyzed using Kaplan-Meier method.|Baseline (Day 1) up to Day 29|Intent to treat population included all randomized participants who received the study drug.|||days||95% Confidence Interval|Median
2604656|NCT02118766|Secondary|Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Day 29|ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Percentage of participants with an ISGA score of 0 or 1 were reported.|Day 29|Intent to treat population included all randomized participants who received the study drug.|||percentage of participants|||Number
2604657|NCT02118766|Primary|Number of Participants With Clinically Significant Change From Baseline in Laboratory Values at Day 29|Laboratory values included: Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Albumin, Blood Urea Nitrogen, Creatinine, Hematocrit, Hemoglobin, Lymphocytes, Monocytes, Neutrophils, Platelets, Basophils, Eosinophils, Red blood cell count, White blood cell count, Total bilirubin and Glucose (nonfasting), Potassium, Total Protein, and Sodium. Clinical significance of change from baseline value was determined by investigator.|Baseline, Day 29|Safety population included all randomized participants who received at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.|||participants|||Number
2605675|NCT02107339|Secondary|Pain Scores 2 Hours After PACU Arrival|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores at 120 minutes after PACU admission||||units on a scale||Inter-Quartile Range|Median
2604659|NCT02118766|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to end of study that were absent before treatment or that worsened relative to pre-treatment state.|AEs: Baseline (Day 1) up to Day 29, SAEs: Baseline (Day 1) up to Day 36|Safety population included all randomized participants who received at least 1 confirmed dose of study drug, and had at least 1 post-baseline assessment.|||participants|||Number
2604660|NCT02118766|Primary|Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Day 29|ISGA assessed the severity of AD (except scalp and venous access area) on a 5-point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of AD. Grades for classification of severity: 0= clear (minor residual hypo/hyper pigmentation, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Treatment success was defined as an ISGA score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement from baseline.|Day 29|Intent to treat population included all randomized participants who received the study drug.|||percentage of participants|||Number
2604661|NCT02118714|Secondary|Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Inhibin B|Serum hormones levels will be tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum Inhibin B.|From Week 0 up to Treatment Period Week 26 and Observation Period Week 52|All participants in the Safety Analysis Set (defined as enrolled participants who receive >= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.|||picogram per milliliter (pg/mL)||Standard Deviation|Mean
2604662|NCT02118714|Secondary|Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in in Follicle Stimulating Hormone (FSH)|Serum hormones levels will be tested during the Treatment and Observational Periods. A positive change from baseline indicated an increase in serum follicle stimulating hormone.|From Week 0 to Treatment Week 26 and Observation Week 52|All participants in the Safety Analysis Set (defined as enrolled participants who receive >= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.|||International Units/Liter (IU/L)||Standard Deviation|Mean
2604663|NCT02118714|Secondary|Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Lutenizing Hormone (LH)|Serum hormones levels will be tested during the Treatment and Observational Periods. A positive change from baseline indicated an increase in serum lutenizing hormone.|From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52|All participants in the Safety Analysis Set (defined as enrolled participants who receive >= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.|||International Units/Liter (IU/L)||Standard Deviation|Mean
2604664|NCT02118714|Secondary|Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Estradiol|Serum hormones levels were tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum estradiol.|From Week 0 up to Treatment Period Week 26 and Observation Period Week 52|All participants in the Safety Analysis Set (defined as enrolled participants who receive >= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.|||Picomoles Per Litre (pmol/L)||Standard Deviation|Mean
2604665|NCT02118714|Secondary|Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Serum Testosterone|Serum hormones levels will be tested during the Treatment and Observational Periods. A negative change from baseline indicated a decrease in serum testosterone.|From Week 0 up to Treatment Period Week 26 and Observation Period Week 52|All participants in the Safety Analysis Set (defined as enrolled participants who receive >= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.|||nanomole/liter (nmol/L)||Standard Deviation|Mean
2604666|NCT02118714|Secondary|Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Semen Volume|Duplicate semen samples will be collected during the Treatment and Observation Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a decrease in semen volume.|From Week 0 to up to Treatment Period Week 26 and Observation Period Week 52|All participants in the Safety Analysis Set (defined as enrolled participants who receive >= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.|||milliliter (mL)||Standard Deviation|Mean
2604667|NCT02118714|Secondary|Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Morphology|Duplicate semen samples will be collected during the Treatment and Observational Periods. The percentage of sperm with normal versus abnormal morphology will be determined via microscopic analysis. A positive change from baseline indicates an improved sperm morphology.|From Week 0 up to Treatment Period Week 26 and Observation Period Week 52|All participants in the Safety Analysis Set (defined as enrolled participants who receive >= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.|||percentage of normal||Standard Deviation|Mean
2604668|NCT02118714|Secondary|Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Motility|Duplicate semen samples will be collected during the Treatment and Observation Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a lower sperm motility (worsening).|From Week 0 up to Treatment Period Week 26 and Observation Observation Week 52|All participants in the Safety Analysis Set (defined as enrolled participants who receive >= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.|||percent motility||Standard Deviation|Mean
2604683|NCT02118597|Secondary|Percentage of Participants With Virological Response|Virological response is defined as HCV RNA <15 IU/mL.|Weeks 4, 8, 12, and 24|Intent to treat (ITT) population included all enrolled participants. Here, 'n' indicated number of participants with virological response data at evaluated time points.|||percentage of participants|||Number
2604669|NCT02118714|Secondary|Change From Baseline up to Treatment Period Week 26 and Observation Period Week 52 in Sperm Concentration|Duplicate semen samples will be collected during the Treatment and Observational Periods. The average of the 2 samples were used as the value for that scheduled collection period. A negative change from baseline indicated a decrease in sperm concentration.|From Week 0 up to Treatment Period Week 26 and Observation Period Week 52|All participants in the Safety Analysis Set (defined as enrolled participants who receive >= 1 dose of Atrasentan) with evaluable data at both baseline and the given time point.|||sperm * million per milliliter(X10^6/mL)||Standard Deviation|Mean
2604670|NCT02118714|Secondary|Percentage of Participants Who Entered the Observation Period and Did Not Return to Within 15% of Baseline Sperm Concentration or Above During the 52-Week Observational Period|The percentage of participants who entered the Observational Period and did not return to within 15% of Baseline sperm concentration or above during the 52-week Observational Period. Duplicate semen samples were to be collected during the Observational Period. Sperm concentration was calculated as measure of the number sperm per milliliter of semen. Duplicate semen samples were collected. The average of the 2 samples were used as the value for that scheduled collection period.|Up to 52 weeks after the Treatment Period|Evaluable Set|||percentage of participants|||Number
2604671|NCT02118714|Primary|Percentage of Subjects With a Sperm Concentration < 15 Million Per mL by Treatment Week 26|Percentage of Subjects with a Sperm Concentration < 15 million per mL by Treatment Week 26. Sperm concentration was calculated as measure of the number sperm per milliliter of semen. Duplicate semen samples were collected. The average of the 2 samples were used as the value for that scheduled collection period.|Up to 26 weeks|Evaluable Set: Subjects who met 1 of the following: Study drug compliance ≥ 70%, completed Treatment Period, all planned sperm samples collected; or 2) at least 1 dose study drug, a sperm concentration value that was <15 million/mL observed by the end of the Treatment Period or had a ≥50% reduction from Baseline at the end of the Treatment Period.|||percentage of participants|||Number
2604672|NCT02118610|Secondary|Improvement in Cognitive Function|Neuropsychological testing will be done at baseline and endpoint using the MATRICS battery. A composite score as well as individual scores will be will be the outcome. This assessment total minimum score of -10 and maximum score of 80. The higher the score the better the outcome.|Baseline and 4 weeks (endpoint)||||score on a scale||Standard Deviation|Mean
2604673|NCT02118610|Primary|Positive and Negative Symptom Improvement|"Measured by the Brief Psychiatric Rating Scale, positive symptom subfactor, Scale for the Assessment of Negative Symptoms (SANS) and Brief Negative Symptom Scale (BNSS).~The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from 1=Not Present to 7=Very Severe. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating."|Baseline and 4 weeks (endpoint)||||score on a scale||Standard Deviation|Mean
2604674|NCT02118597|Secondary|Percentage of Participants With Positive Predictive Value of Previous Virological Response (Null-response, Partial Response, or Relapse)|Previous virological response was sub-categorized into the following categories: null-response, partial response, or relapse. Predictive value of these sub-categories for SVR rate were to be assessed.|Up to 72 weeks|Predictive values of previous virological response could not be analyzed as the SVR24 rate was based on one participant.||||||
2604675|NCT02118597|Secondary|Predictive Value of HCV Disease Characteristics|HCV disease characteristics evaluated were HCV genotype (subtype), including HCV 1(a) and HCV 1(b). Predictive value of these disease characteristics for SVR rate were to be assessed.|Screening (before Week 1)|Predictive values of HCV disease characteristics could not be analyzed as the SVR24 rate was based on one participant.||||||
2604676|NCT02118597|Secondary|Percentage of Participants With Positive Predictive Value of Liver Fibrosis|The following sub-categories of liver fibrosis were determined in this study: 1) no cirrhosis, 2) bridging fibrosis and 3) cirrhosis. Predictive value of these sub-categories of liver fibrosis for SVR rate was to be assessed.|Screening (before Week 1)|Predictive values of sub-categories of liver fibrosis could not be analyzed as the SVR24 rate was based on one participant.||||||
2604677|NCT02118597|Secondary|Percentage of Participants With Positive Predictive Value of Participant Demographics for SVR Rate|Demographic characteristics recorded were age and gender. Predictive value of these characteristics for SVR rate was to be assessed.|Screening (before Week 1)|Predictive values of participant demographics could not be analyzed as the SVR24 rate was based on one participant.||||||
2604678|NCT02118597|Secondary|Number of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to 72 weeks|ITT population included all enrolled participants.|||participants|||Number
2604679|NCT02118597|Secondary|Number of Participants With Treatment Discontinuation|Treatment discontinuation is reported by sub-categories of reasons for treatment discontinuation. Futility rule is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24.|Up to Week 48|ITT population included all enrolled participants.|||participants|||Number
2604680|NCT02118597|Secondary|Number of Participants With Treatment Discontinuation Due to Futility|Treatment discontinuation due to futility is defined as HCV RNA drop <3 log10 at Week 8, HCV RNA >/=100 IU/mL at Week 12, or HCV RNA >/=15 IU/mL at Week 24.|Up to Week 48|ITT population included all enrolled participants.|||participants|||Number
2604681|NCT02118597|Secondary|Number of Participants With Virological Relapse|Virological response is defined as HCV RNA >/=15 IU/mL during the treatment free follow-up period in participants with virological response at the end of treatment.|Week 49 up to Week 72|ITT population included all enrolled participants.|||participants|||Number
2604682|NCT02118597|Secondary|Number of Participants With Virological Breakthrough|Virological breakthrough is defined as either HCV RNA >=15 IU/mL in participants with prior virological response or as an increase in HCV RNA >/=1 log10 above nadir.|Up to Week 48|ITT population included all enrolled participants.|||participants|||Number
2625782|NCT01908972|Secondary|Number of Participants With Growth Retardation Within 16 Weeks|Number of Participants with Growth Retardation within 16 weeks..|up to 16weeks||||Participants|||Count of Participants
2604684|NCT02118597|Primary|Sustained Virological Response 24 (SVR24) Rate|The SVR 24 rate is defined as percentage of participants with Hepatitis C virus (HCV) Ribonucleic Acid (RNA) less than 15 international unit/milliliter (IU/mL) after the 24-weeks follow-up.|24 weeks after end of treatment (EOT) at Week 72|Due to the early termination of the study follow-up of the vast majority of the participants was not possible and data were not collected. Therefore, results for this outcome measure are based on one participant.|||percentage of participants|||Number
2604685|NCT02118441|Secondary|Complication Rate (Hematoma)|A hematoma was defined a collection of blood or formation of a bruise surrounding the site of radial artery catheterization|up to 5 minutes||||percentage of participants|||Number
2604686|NCT02118441|Secondary|Number of Re-directions|A re-direct was defined as the needle being purposefully withdrawn at least 5 mm and re-directed (but not removed from the skin entirely).|up to 5 minutes||||number of re-directs||Inter-Quartile Range|Median
2604687|NCT02118441|Secondary|Number of Attempts|An attempt was defined as a new purposeful penetration of the skin with the needle (i.e., following complete withdrawal of the needle from the skin).|up to 5 minutes||||number of attempts||Inter-Quartile Range|Median
2604688|NCT02118441|Primary|Time to Successful Radial Arterial Catheterization|The time to successful radial arterial catheterization was defined as time zero to time of placement. Time zero for the DP group began when the anesthesiologist's fingers were placed on the patient with the purpose of palpating the artery. Time zero for the US group began when the US transducer was first placed on the patient's skin for the purpose of identifying the radial artery. Time to placement was defined as the interval from time zero until the time at which an arterial tracing was viewed on the monitor.|up to 5 minutes||||seconds||Inter-Quartile Range|Median
2604689|NCT02118428|Secondary|Coagulation Parameter in Patients - International Normalized Ratio (INR)|INR measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.|Days 0, 1, 2, 3|Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion|||ratio||Standard Deviation|Mean
2604690|NCT02118428|Secondary|Coagulation Parameter in Patients - Activated Partial Thromboplastin Time|Activated partial thromboplastin time measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.|Days 0, 1, 2, 3|Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion|||seconds||Standard Deviation|Mean
2604691|NCT02118428|Secondary|Coagulation Parameter in Patients - Prothrombin Time|Prothrombin time measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.|Days 0, 1, 2, 3|Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion|||seconds||Standard Deviation|Mean
2604692|NCT02118428|Secondary|Biochemistry Parameter in Patients - Potassium|Potassium measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.|Days 0, 1, 2, 3|Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion|||mmol/L||Standard Deviation|Mean
2604693|NCT02118428|Secondary|Hematology Parameter in Patients - White Blood Cell (WBC) Count|WBC count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.|Days 0, 1, 2, 3, 7, 28|Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion|||Cells x 10e9/L||Standard Deviation|Mean
2604694|NCT02118428|Secondary|Hematology Parameter in Patients - Red Blood Cell (RBC) Count|RBC count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.|Days 0, 1, 2, 3, 7, 28|Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion|||Cells x 10e12/L||Standard Deviation|Mean
2604695|NCT02118428|Secondary|Hematology Parameter in Patients - Platelet Count|Platelet count in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.|Days 0, 1, 2, 3, 7, 28|Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion|||Cells x 10e9/L||Standard Deviation|Mean
2604696|NCT02118428|Secondary|Hematology Parameter in Patients - Total Hemoglobin|Total hemoglobin measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.|Days 0, 1, 2, 3, 7, 28|Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion|||g/dL||Standard Deviation|Mean
2604697|NCT02118428|Secondary|Hematology Parameter in Patients - Hematocrit|Hematocrit measure in study participants. Study participants may have received 1 or 2 blood product transfusions over 3 days while on study. These measurements were taken relative to the first transfusion only, for consistency.|Days 0, 1, 2, 3, 7, 28|Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion|||percentage||Standard Deviation|Mean
2604698|NCT02118428|Secondary|Biochemistry Parameter in Fresh Whole Blood Products - Potassium|Potassium measurement in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject.|Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)|Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion|||mmol/L||Standard Deviation|Mean
2604699|NCT02118428|Secondary|Hematology Parameter in Fresh Whole Blood Products - White Blood Cell (WBC) Count|WBC count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject.|Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)|Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion|||Cells x 10e9/L||Standard Deviation|Mean
2605578|NCT02108171|Other Pre-specified|Time to Spontaneous Breathing of Patients Receiving Intranasal Dexmedetomidine|Time to spontaneous breathing of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and adequate ventilation|1 day||||minutes|||Number
2604700|NCT02118428|Secondary|Hematology Parameter in Fresh Whole Blood Products - Platelet Count|Platelet count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject.|Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)|Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion|||Cells x 10e9/L||Standard Deviation|Mean
2604701|NCT02118428|Secondary|Hematology Parameter in Fresh Whole Blood Products - Red Blood Cell (RBC) Count|RBC count in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject.|Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)|Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion|||Cells x 10e12/L||Standard Deviation|Mean
2604702|NCT02118428|Secondary|Hematology Parameter in Fresh Whole Blood Products - Total Hemoglobin|Total hemoglobin measurement in Fresh Whole Blood products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject.|Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)|Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion|||g/dL||Standard Deviation|Mean
2604703|NCT02118428|Secondary|Hematology Parameter in Fresh Whole Blood (FWB) Products - Hematocrit|Hematocrit measurement in FWB products. Blood products were collected independently from study enrollment and stored for maximum of 7 days before assignment/transfusion to a study subject.|Post-blood product collection (Day -7 to Day 0 per transfusion), prior to transfusion (Day 0 per transfusion)|Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion|||percentage||Standard Deviation|Mean
2604704|NCT02118428|Secondary|Bacterial Contamination of Fresh Whole Blood (FWB) Products|"Bacterial culture on blood products - products were collected within 7 days before transfusion to the study subject.~Control products were only sampled post-collection, so no results for post-Mirasol treatment.~All samples in Mirasol group that were positive post-collection became negative post-Mirasol treatment.~All samples in Mirasol group that were positive post-Mirasol treatment were negative post-collection. These samples were likely contaminated in the clinical laboratory after Mirasol treatment during sampling for culture."|immediately post-blood product collection & within 7 days before transfusion, post-Mirasol treatment (within 24 hours post-blood product collection) & within 7 days before transfusion|Intent-to-treat = All randomized subjects who underwent at least 1 study transfusion|||percentage of blood product samples||95% Confidence Interval|Number
2604705|NCT02118428|Primary|Percentage of Participants With Incidence of Transfusion-transmitted Malaria|Percentage of Participants who contracted transfusion-transmitted malaria (TTM)|Up to 28 (+4) days after the initial whole blood transfusion (measured within 24 hours prior to each transfusion and at 24 (± 4) hours, 2 days, 3 days, 7 (+1) days, and 28 (+4) days after the initial whole blood transfusion)|Evaluable population = randomized subjects who received up to 2 whole blood transfusions and no non-study blood products, who did not receive any anti-malarial treatment, who had no significant protocol deviations and who additionally were non parasitemic pre-transfusion and received at least one parasitemic fresh whole blood product|||Percentage of participants|||Number
2604706|NCT02117999|Secondary|Central Retinal Thickness|Central retinal thickness (1 mm ETDRS map) will be measured before and after CXL procedures|Changes from baseline at 12 months.|1 mm central retinal thickness assessed by SD-OCT|||micrometers||Standard Deviation|Mean
2604707|NCT02117999|Secondary|Contrast Sensitivity|Contrast sensitivity tested using Pelli-Robson chart|Changes from baseline at 12 months.|Contrast-sensitivity function assessed by Pelli-Robson charts|||log||Standard Deviation|Mean
2604708|NCT02117999|Secondary|Visual Acuity|Visual acuity tested using ETDRS|Changes from baseline at 12 months.|Corrected distance visual acuity|||LogMAR||Standard Deviation|Mean
2604709|NCT02117999|Secondary|Optical Aberrations|Optical aberrations of the eye will be measured using dynamic skyascopy. Corneal wavefront aberration will be measured using Placido disk topographer and Scheimpflug tomographer.|Changes from baseline at 12 months.|Corneal high-order aberrations|||micrometers||Standard Deviation|Mean
2604710|NCT02117999|Primary|Corneal Endothelial Cell Density|Endothelial cell density (ECD) will be evaluated using specular microscopy|Changes from baseline in ECD at 12 months|Analysis of changes from baseline in each group was made using the paired Student t-test. Treatment effects were assessed using repeated measures ANOVA between groups and time (3 days, 7 days, 1-, 3-, 6- and 12-months). The outcome measures over time were corrected for baseline values.|||cells/mm2||Standard Deviation|Mean
2604711|NCT02117999|Primary|K-max|Measuring maximum keratometry (K-max), measured in diopters (D), derived from computerized videokeratography.|Changes from baseline in Kmax at 12 months|Analysis of changes from baseline in each group was made using the paired Student t-test. Treatment effects were assessed using repeated measures ANOVA between groups and time (3 days, 7 days, 1-, 3-, 6- and 12-months). The outcome measures over time were corrected for baseline values.|||Diopters (D)||Standard Deviation|Mean
2604712|NCT02117934|Primary|Percentage of Subjects With Type 2 Diabetes Mellitus Who Have a Seroprotective Immune Response|Percentage of subjects with type 2 diabetes mellitus who have a seroprotective immune response (anti-HBs ≥ 10 milli-international unit (mIU)/mL) who receive HEPLISAV compared with subjects who receive Engerix-B|Week 28|Per-Protocol Diabetes Population:Randomized subjects with type 2 diabetes mellitus (clinical diagnosis of T2DM taking at least oral or non-insulin injectable hypoglycemic agent and/or insulin) who received all study injections, had no major protocol deviations, and had anti-HBs levels obtained within the study visit window at Week 28.|||Percentage of participants||95% Confidence Interval|Number
2604713|NCT02117934|Primary|Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest|The percentage of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations. Immune-mediated AESIs are AEs that were confirmed to be autoimmune in etiology.|Week 56|Safety Population: All participants who received at least 1 study injection and who had any post-baseline safety data|||percentage of participants|||Number
2604715|NCT02117687|Secondary|Conjunctival Hyperaemia in the Study Eye|Macroscopic conjunctival hyperemia (eye redness) is graded in the study eye on a 5-point scale (none, trace, mild, moderate, severe).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Subjects|||Number
2604716|NCT02117687|Secondary|Change From Baseline in Conjunctival Staining in the Study Eye|The conjunctiva is the clear membrane covering the white surface of the eye. Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining) in the temporal and nasal locations. A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Scores on a Scale||Standard Deviation|Mean
2604717|NCT02117687|Secondary|Change From Baseline in Corneal Staining in the Study Eye|The cornea is the transparent front part of the eye which covers the iris and pupil. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). A negative number change from baseline represents a decrease in corneal staining (improvement) and a positive number change from baseline represents an increase in corneal staining (worsening).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Scores on a Scale||Standard Deviation|Mean
2604718|NCT02117687|Secondary|Work Productivity and Activity Impairment Questionnaire Score|The Work Productivity and Activity questionnaire assesses the effect of dry eye on the ability of subjects to work and perform regular activities on a scale from 0 to 10 during the past 7 days (0=dry eye had no effect on my work/daily activities to 10=dry eye completely prevented me from working/doing my daily activities). Since not all subjects were in full time employment during the study, not all items of the questionnaire were applicable to all subjects at each visit. Outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, who did not adhere to a pre-defined list of protocol violation criteria, and who had data for this data point|||Scores on a Scale||Standard Deviation|Mean
2604719|NCT02117687|Secondary|Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye|TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement) and a negative number change from baseline indicates a decrease in TBUT (worsening).|Baseline, Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Seconds||Standard Deviation|Mean
2604720|NCT02117687|Secondary|Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale|Investigators assess global treatment efficacy on a 4-point scale (very satisfactory, satisfactory, poor, very poor).|Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Subjects|||Number
2604721|NCT02117687|Secondary|Subject Assessment of Treatment Acceptability on a 5-Point Scale|Subjects assess treatment acceptability (likability and comfort) on a 5-point scale (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree).|Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Subjects|||Number
2604722|NCT02117687|Secondary|Subject Global Assessment of Treatment Efficacy on a 5-Point Scale|Subjects assess global treatment efficacy compared to baseline on a 5-point scale (much worse, worse, about the same, improved, much improved).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Subjects|||Number
2604723|NCT02117687|Secondary|Subject Assessment of Dry Eye Symptoms on a 5-Point Scale|Subjects assess dry eye symptoms on a 5-point scale (none, mild, moderate, severe, very severe).|Baseline, Day 35, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Subjects|||Number
2604724|NCT02117687|Secondary|Change From Baseline in the Schirmer Test in the Study Eye|The Schirmer's Test measures the rate of secretion of tears produced by the study eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).|Baseline, Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Millimeters (mm)/5 Minutes||Standard Deviation|Mean
2604725|NCT02117687|Secondary|Change From Baseline in Ocular Surface Disease Index© (OSDI) Score|The OSDI is a 12-question survey for patients to document their dry eye disease symptoms on a 5-point scale (0=none of the time and 4=all of the time). Higher scores represent greater disability. Scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement and a positive number change from baseline represents a worsening.|Baseline, Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Scores on a Scale||Standard Deviation|Mean
2605337|NCT02110693|Secondary|Cigarette Smoking Risk|Measured by the Fagerstrom Test for Nicotine Dependence. The range of scores on the Fagerstrom Test if from 0 (no risk) to 10 (highest risk). High risk is considered a score of 6 or greater.|baseline|Adult Primary Care patients|||Spearman Correlation||95% Confidence Interval|Number
2604726|NCT02117687|Secondary|Change From Baseline in Global Ocular Staining Score in the Study Eye|Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.|Baseline, Month 3|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Scores on a Scale||Standard Deviation|Mean
2604727|NCT02117687|Primary|Change From Baseline in Global Ocular Staining Score in the Study Eye|Global ocular staining of the study eye was graded from 0 to 15 and was the sum of corneal fluorescein staining severity, nasal conjunctiva lissamine green staining severity, and temporal conjunctiva lissamine green staining severity. Staining of the cornea followed ocular administration of fluorescein dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Staining of the conjunctiva followed ocular administration of lissamine green dye and was graded on a 6-point scale (0=no staining to 5=diffuse staining). Conjunctival staining was evaluated in two zones, nasal and temporal.|Baseline, Day 35|Per Protocol: all randomized subjects who received at least one dose of the study product, had at least one follow-up visit, and who did not adhere to a pre-defined list of protocol violation criteria|||Scores on a Scale||Standard Deviation|Mean
2604728|NCT02117648|Primary|PK: Maximum Concentration (Cmax) of Abemaciclib||Period 1: Predose; 1, 2, 4, 6, 8, 10, 24, 48, 72, 96,120,144,168hr, Period 2: 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240hr Post dose|All participants who received at least 1 dose of study drug and had evaluable cmax data.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2604729|NCT02117648|Primary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of Abemaciclib||Period 1: Predose; 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168hr, Period 2: 1, 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240hr Post dose|All participants who received at least 1 dose of study drug and had evaluable AUC(0-∞) data.|||nanogram*hour/milliliter(mL) ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2604730|NCT02117570|Primary|Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (65- to 85-Year Age Cohort)|An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect; is life-threatening; or requires or prolongs inpatient hospitalization.|AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)|All randomized participants aged 65 to 85 who received at least 1 dose of study vaccine|||Percentage of participants||95% Confidence Interval|Number
2604731|NCT02117570|Primary|Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 3 vaccination to within 14 days after Dose 3|All randomized participants aged 65 to 85 years who received all 3 doses of study vaccine|||Percentage of participants||95% Confidence Interval|Number
2604732|NCT02117570|Primary|Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 2 vaccination to within 14 days after Dose 2|All randomized participants aged 65 to 85 years who received at least 2 doses of study vaccine|||Percentage of participants||95% Confidence Interval|Number
2604733|NCT02117570|Primary|Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 1 vaccination to within 7 days of Dose 1|All randomized participants aged 65 to 85 years who received at least 1 dose of study vaccine|||Percentage of participants||95% Confidence Interval|Number
2604734|NCT02117570|Primary|Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 3 vaccination to 14 days after Dose 3|All randomized participants aged 65 to 85 years who received all 3 doses of study vaccine|||Percentage of participants||95% Confidence Interval|Number
2604735|NCT02117570|Primary|Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 2 vaccination to 14 days after Dose 2|All randomized participants aged 65 to 85 years who received at least 2 doses of study vaccine|||Percentage of participants||95% Confidence Interval|Number
2604736|NCT02117570|Primary|Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 1 vaccination to within 7 days of Dose 1|All randomized participants aged 65 to 85 years who received at least 1 dose of study vaccine.|||Percentage of participants||95% Confidence Interval|Number
2604737|NCT02117570|Primary|Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (50- to 64-Year Age Cohort)|An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect; is life-threatening; or requires or prolongs inpatient hospitalization.|AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)|All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine|||Participants||95% Confidence Interval|Number
2604738|NCT02117570|Primary|Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 3 vaccination to within 14 days after Dose 3|All randomized participants aged 50 to 64 years who received all 3 doses of study vaccine|||Percentage of participants||95% Confidence Interval|Number
2604739|NCT02117570|Primary|Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 2 vaccination to within 14 days after Dose 2|All randomized participants aged 50 to 64 years who received at least 2 doses of study vaccine|||Percentage of participants||95% Confidence Interval|Number
2604740|NCT02117570|Primary|Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort)|Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= >40.0°C (>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= >2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.|From Day of Dose 1 vaccination to within 7 days of Dose 1|All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine|||Percentage of participants||95% Confidence Interval|Number
2604762|NCT02117414|Primary|Ventricular Sensing Amplitude (R-wave)|Number of successful patients who do not experience a decrease in ventricular sensing amplitude of >50% from the pre-MRI/waiting period to the one month post-MRI/waiting period, or a one month post-MRI/waiting value <3mV accompanied by a decrease of >25% from the pre-MRI/waiting period to the one month post-MRI/waiting period.|Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit|Only subjects with measured ventricular sensing amplitude values both pre-MRI/waiting period and post-MRI/waiting period were used in the analysis.|||Successful participants|||Number
2604741|NCT02117570|Primary|Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 3 vaccination to within 14 days after Dose 3|All randomized participants aged 50 to 64 years who received all 3 doses of study vaccine.|||Percentage of participants||95% Confidence Interval|Number
2604742|NCT02117570|Primary|Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 2 vaccination to within 14 days after Dose 2|All randomized participants aged 50 to 64 years who received at least 2 doses of study vaccine|||Percentage of participants||95% Confidence Interval|Number
2604743|NCT02117570|Primary|Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort)|Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= >5.0 to 10.0 cm; severe= >10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.|From Day of Dose 1 vaccination to within 7 days after Dose 1|All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine|||Percentage of participants||95% Confidence Interval|Number
2604744|NCT02117544|Secondary|Low Contrast Visual Acuity (LCVA) Distance Monocular|Visual Acuity (clarity or sharpness of vision) was measured at low contrast level. LCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.|Day 1, 10 minutes after lens insertion, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).|||logMAR|Participants|Standard Error|Least Squares Mean
2604745|NCT02117544|Secondary|HCVA Intermediate Monocular|Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 1 meter using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.|Day 1, 10 minutes after lens insertion, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).|||logMAR|Participants|Standard Error|Least Squares Mean
2604746|NCT02117544|Secondary|HCVA Distance Monocular|Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 6 meters using an ETDRS chart and measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.|Day 1, 10 minutes after lens insertion, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).|||logMAR|Participants|Standard Error|Least Squares Mean
2604747|NCT02117544|Primary|High Contrast Visual Acuity (HCVA) Near Monocular|Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.|Day 1, 10 minutes after lens insertion, each product|This analysis population includes all randomized subjects excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan (DEP).|||logMAR|Participants|Standard Error|Least Squares Mean
2604748|NCT02117479|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|A treatment-emergent AE was defined as an event occurring after exposure to at least 1 dose of study drug (ruxolitinib or placebo). A treatment-related AE was defined as an event with a definite, probable, or possible causality to study medication. A serious AE is an event resulting in death, hospitalization, persistent or significant disability/incapacity, or is life threatening, a congenital anomaly/birth defect or requires medical or surgical intervention to prevent 1 of the outcomes above. The intensity of an AE was graded according to the National Cancer Institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03: Grade 1 (Mild); Grade 2 (Moderate); Grade 3 (Severe); Grade 4 (life-threatening).|Baseline through approximately 30 days post treatment discontinuation; up to 6-months or to the data cutoff 11FEB2016.|The safety evaluable population consisted of all participants exposed to at least 1 dose of study drug (ruxolitinib or placebo).|||Participants|||Count of Participants
2604749|NCT02117479|Secondary|Duration of Response|Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) until the first date Progressive Disease (PD) was objectively documented or until the date of death.|Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||days||95% Confidence Interval|Median
2604763|NCT02117414|Primary|Ventricular Pacing Capture Threshold (VPCT)|Number of successful patients, where success is defined as not increasing VPCT by more than 0.5V from pre-MRI/waiting to one month post.|Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the MRI/waiting period visit, and all the subjects must have valid VPCT measurements pre-MRI/waiting period and post-MRI/waiting period.|||Successful participants|||Number
2604750|NCT02117479|Secondary|Objective Response Rate (ORR)|Objective response rate determined by radiographic disease assessments per RECIST (v1.1), by investigator assessment and was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) at any post baseline visit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) : Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions with no worsening of non-target lesions and no new lesions; Overall Response (OR) = CR + PR.|Baseline through end of study; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||percentage of participants|||Number
2604751|NCT02117479|Secondary|Percentage of Participants Achieving Progression Free Survival (PFS)|PFS is defined as the time from randomization until the earliest date of disease progression determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause if sooner. Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.|Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||percentage of participants||95% Confidence Interval|Median
2604752|NCT02117479|Secondary|Progression-free Survival (PFS)|Progressive Disease (PD) is defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, unequivocal progression of non-target lesions, or the appearance of new lesions.|Randomization to disease progression, or death due to any cause if sooner; up to 6-months or to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||days||95% Confidence Interval|Median
2604753|NCT02117479|Primary|Overall Survival (OS)|Overall survival is reported here based on the number of deaths from randomization up to 6-months or to the data cutoff 11FEB2016.|Randomization until death due to any cause; up to the data cutoff 11FEB2016.|The intent-to-treat (ITT) population consisted of all participants randomized to the study.|||Participants|||Count of Participants
2604754|NCT02117427|Primary|Percent (%) of Hb Measurements After Implantation Within 9-12 g/dL|Due to the small sample size and the dispersion of total EPO secretion, the efficacy analyses were performed on all of the patients as a single cohort of intended dose between 25 and 45 U/Kg/d.|52 weeks|Due to the small sample size and the dispersion of total EPO secretion, the efficacy analyses were performed on all of the patients as a single cohort of intended dose between 25 and 45 U/Kg/d. One subject enrolled was discontinued prior to study procedures and became no longer eligible.|||percent||Full Range|Mean
2604755|NCT02117427|Primary|Percent (%) of Hb Measurements After Implantation Within 9-11 g/dL||52 weeks|Due to the small sample size and the dispersion of total EPO secretion, the efficacy analyses were performed on all of the patients as a single cohort of intended dose between 25 and 45 U/Kg/d. One subject enrolled was discontinued prior to study procedures and became no longer eligible.|||percent||Full Range|Mean
2604756|NCT02117427|Primary|Total EPO Secretion||up to 52 weeks|Due to the small sample size and the dispersion of total EPO secretion, the efficacy analyses were performed on all of the patients as a single cohort of intended dose between 25 and 45 U/Kg/d. One subject enrolled was discontinued prior to study procedures and became no longer eligible.|||U/Kg/d||Full Range|Mean
2604757|NCT02117414|Secondary|Atrial Sensing Amplitude|Number of successful patients, where success is defined as not decreasing atrial sensing amplitude by more than 50% from pre-MRI/waiting to one month post.|MRI/waiting visit to 1-month post-MRI/Waiting visit|Only subjects with measured atrial sensing amplitude values at both the pre-MRI/waiting period and post-MRI/waiting period were used in the analysis.|||Successful participants|||Number
2604758|NCT02117414|Secondary|Atrial Pacing Capture Threshold (APCT)|Number of successful patients, where success is defined as not increasing APCT by more than 0.5V from pre-MRI/waiting to one month post.|Pre-MRI/Waiting Period visit to 1-month post-MRI/Waiting Period visit|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the MRI/waiting period visit, and all the subjects must have valid APCT measurements pre-MRI/waiting period and post-MRI/waiting period.|||Successful participants|||Number
2604759|NCT02117414|Secondary|Superior Vena Cava (SVC) Defibrillation Impedance|Number of subjects whose SVC defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms|1-month post-MRI/Waiting Period visit|Only randomized subjects with measured SVC defibrillation impedance one month post-MRI/waiting period were used in the analysis. The percentages of subjects with an SVC defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit were calculated.|||Successful participants|||Number
2604760|NCT02117414|Secondary|RV Defibrillation Impedance|Number of subjects whose RV defibrillation impedance at the one-month post-MRI/waiting period visit is between 20 and 100 ohms|1-month post-MRI/Waiting Period visit|Only randomized subjects with measured RV defibrillation impedance one month post-MRI/waiting period were used in the analysis. The percentages of subjects with an RV defibrillation impedance between 20 and 100 ohms at the one month post-MRI/waiting period visit were calculated.|||Successful participants|||Number
2604761|NCT02117414|Secondary|System-related Complications|Number of subjects free of a system-related complication. The system includes the ICD and lead(s) attached to it.|Implant to 4 months post-implant|All subjects who are successfully implanted with the Evera MRI Study System or have an implant attempt will be included in the analysis.|||Successful participants|||Number
2604764|NCT02117414|Primary|MRI-related Events|Number of patients free of MRI-related events. Events include MRI-related complications, sustained tachyarrhythmia, and MRI-related loss of pacing ability.|MRI procedure to 1-month post-MRI|A total of 156 subjects underwent an MRI scan at the MRI/waiting period visit; of them 147 were followed through the one month post-MRI visit or later and are included in the analysis.|||Participants free of MRI-related events|||Number
2604765|NCT02117349|Secondary|Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs)|Clinically significant changes in safety measures are recorded as adverse events. Participants with TEAEs that are deemed by the principal investigator or the independent data monitoring committee as possibly or definitely treatment-related (including device-related) are included in the count for this secondary outcome measure.|within 97 days|Safety Population|||Participants|||Count of Participants
2604766|NCT02117349|Secondary|Number of Participants Who Reached Hemostasis at the TBS Within 5 Minutes|Count of Participants who Reached Hemostasis at the TBS within 5 minutes of the first study drug application|within 5 minutes|mITT|||Participants|||Count of Participants
2604767|NCT02117349|Primary|Number of Participants Who Reached Hemostasis at the Target Bleeding Site (TBS) Within 4 Minutes|Count of Participants who Reached Hemostasis at the TBS within 4 minutes of the first study drug application|within 4 minutes|modified Intent to Treat (mITT)|||Participants|||Count of Participants
2604768|NCT02117310|Primary|Number of Participants for Which Angiograghy is Used to Visualize Nasoseptal Mucosa Better Than What is Done Standard of Care in This Surgery.|The researcher will administer ICG, which is already widely used during open neurosurgical procedures, to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case. This study will determine feasibility of other larger clinical trials using this method.|During surgery||||Participants|||Count of Participants
2604769|NCT02117193|Secondary|Breath Alcohol||6 months|||||||
2604770|NCT02117193|Secondary|Profile of Mood States||6 months|||||||
2604771|NCT02117193|Secondary|Hydration Status|Urine Specific Gravity|After each sequence, up to 8 hours||||g/ml||Standard Deviation|Mean
2604772|NCT02117193|Primary|Biochemical Responses|Glucose after each situation in the morning|After each sequence, up to 8 hours||||mg/dl||Standard Deviation|Mean
2604773|NCT02117193|Primary|Neuromuscular Performance|knee extensor isometric torque|After each sequence, up to 8 hours||||Nm||Standard Deviation|Mean
2604774|NCT02117193|Primary|Aerobic Performance|Aerobic performance will be determined through the subject's heart rate|After each sequence, up to 8 hours||||bpm||Standard Deviation|Mean
2604775|NCT02117050|Secondary|Annualized Relapse Rate (ARR)|"A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Episodes indicated by neurologist as relapse in the subjects chart were to be recorded."|Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.||||||
2604776|NCT02117050|Secondary|Change From Baseline in Number of Combined Unique Active (CUA) Lesions, New Time or Enlarging Constant 2 (T2) Lesions, and New Gadolinium Enhanced (Gd+) Time Constant 1 (T1) Lesions at Week 24||Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.||||||
2604777|NCT02117050|Secondary|Change From Baseline in Work Productivity and Activity Impairment- General Health (WPAI-GH) Questionnaire Score at Week 24|WPAI-GH questionnaire is a subject reported quantitative assessment of general health conditions on productivity. The Total WPAI-GH score assessment was to be done on an 11-point scale ranging 0 to 10, with 0 indicating that health problems had no effect on work and 10 indicating that health problems completely prevented from working.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.||||||
2604778|NCT02117050|Secondary|Change From Baseline in TSQM (Version II) - Global Satisfaction, Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 12|The TSQM (Version II) is a validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Effectiveness, side effects, convenience and global satisfaction sub-scales of TSQM were to be used to measure overall satisfaction with medication. Subject were to respond about their satisfaction or dissatisfaction with medication they are taking in terms of effectiveness, side effects, convenience and global satisfaction, each sub-scale ranging on a scale of 0 to 100, where higher scores indicated greater satisfaction.|Baseline, Week 12|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.||||||
2604779|NCT02117050|Secondary|Change From Baseline in TSQM (Version II) - Medication Effectiveness, Side Effects, and Convenience Subscale Scores at Week 24|The TSQM (Version II) is a validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Effectiveness, side effects and convenience sub-scales of TSQM were to be used to measure overall satisfaction with medication. Subject were to respond about their satisfaction or dissatisfaction with medication they are taking in terms of effectiveness, side effects and convenience, each sub-scale ranging on a scale of 0 to 100, where higher scores indicated greater satisfaction.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.||||||
2604780|NCT02117050|Secondary|Change From Baseline in TSQM (Version II) - Total Score at Week 12 and Week 24|The TSQM (Version II) is an 11-item validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Total TSQM score was the average of individual sub-scale scores (effectiveness, side effects, convenience and global satisfaction) and ranged from 0 to 100, where higher scores indicated greater satisfaction.|Baseline, Week 12 and Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.||||||
2604781|NCT02117050|Secondary|Change From Baseline in Multiple Sclerosis Quality of Life-54 (MSQoL-54) Score at Week 24|The MSQOL-54 is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument. MSQoL-54 is a 54 item questionnaire which covers 12 sub-scales along with two summary scores, and two additional single-item measures. The 12 sub-scales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The 2 summary scores are the physical health composite summary and the mental health composite summary. The 2 additional single item measures are satisfaction with sexual function and change in health. Each of the 12 sub-scale scores, the 2 summary scores and 2 single item measures were to be converted into an overall Total Score ranging from 0-100, where higher scores indicated better health status.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.||||||
2604782|NCT02117050|Secondary|Change From Baseline in Patient-Determined Disease Steps Questionnaire (PDDS) Score at Week 24|PDDS questionnaire was to be used to assess the walking ability of subjects. Subjects were to describe their walking ability on scale ranging from 0 to 8, where 0 indicated normal walking and 8 indicated subject's condition as bedridden. Lesser score indicated better walking ability.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for secondary endpoint was not collected.||||||
2604783|NCT02117050|Primary|Change From Baseline in Treatment Satisfaction Score Determined by the Global Satisfaction Sub-scale of the Treatment Satisfaction Questionnaire for Medication (TSQM [Version II]) at Week 24|The TSQM (Version II) is a validated tool that measures patient satisfaction with medical treatments using a 100-point scale. Global satisfaction sub-scale of TSQM was to be used to measure overall satisfaction with medication using a 100-point scale. Subject were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging from 0 to 100, where higher scores indicated greater satisfaction.|Baseline, Week 24|The study enrolled only 1 subject who did not receive any dose. Thus, the data for primary endpoint was not collected.||||||
2604784|NCT02117024|Secondary|Immune Response|Characterize the peripheral blood immunologic response via intracellular cytokine staining (ICS) by flow cytometry and/or enzyme-linked immunosorbent spot (ELISPOT) on cluster of differentiation 8 positive (CD8+) cells following vaccination|Up to 3 years|Data were not collected for Outcome Measure 10 due to study termination (50% enrollment) by the Sponsor on 01 September 2015 due to changing treatment landscape (PD-1 approvals), and a subsequent change in development focus to Immuno-Oncology (IO) combinations. See NCT02439450.||||||
2604785|NCT02117024|Secondary|Survival at 12 Months|Evaluate the proportion of patients who are alive at 12 months following randomization|12 months||||Participants|||Count of Participants
2604786|NCT02117024|Secondary|Survival at 6 Months|Evaluate the proportion of patients who are alive at 6 months following randomization|6 months||||Participants|||Count of Participants
2604787|NCT02117024|Secondary|Time to Progression (TTP)|Evaluate immune-related TTP (irTTP) and also TTP (Time to Progression) by RECIST|Up to 3 years|Time to immune-related progression was calculated from the randomization date up to the date of the first ‘Progressive Disease’ response (Immune-Related Response Criteria) Time to progression was calculated from the randomization date up to the date of the first 'Progressive Disease' response (RECIST Response Criteria).|||Days||95% Confidence Interval|Median
2604788|NCT02117024|Secondary|Progression-Free Survival (PFS)|Evaluate immune-related PFS (irPFS) and PFS by RECIST (Response Evaluation Criteria for Solid Tumors)|Up to 3 years|Calculated from randomization date to earliest date of first 'Progressive Disease' response (Immune-Related / RECIST Response Criteria) or date of death, and censored on the date of the last available post-baseline tumor assessment.|||Days||95% Confidence Interval|Median
2604789|NCT02117024|Secondary|Overall Response Rate (ORR)|Evaluate immune-related ORR (irORR) and also ORR by RECIST (complete response and partial response)|Up to 3 years|Data were not collected for Outcome Measure 5 due to study termination (50% enrollment) by the Sponsor on 01 September 2015 due to changing treatment landscape (PD-1 approvals), and a subsequent change in development focus to Immuno-Oncology (IO) combinations. See NCT02439450.||||||
2604790|NCT02117024|Secondary|6-Month Disease Control Rate (6mDCR)|Evaluate 6-month immune-related DCR (6m-irDCR) and also 6mDCR by RECIST (complete response, partial response, and stable disease at 6 months following randomization)|6 months|Data were not collected for Outcome Measure 4 due to study termination (50% enrollment) by the Sponsor on 01 September 2015 due to changing treatment landscape (PD-1 approvals), and a subsequent change in development focus to Immuno-Oncology (IO) combinations. See NCT02439450.||||||
2604791|NCT02117024|Secondary|Disease Control Rate (DCR)|Evaluate overall immune-related DCR (irDCR) and also DCR by Response Evaluation Criteria in Solid Tumors (RECIST) (complete response, partial response, and stable disease)|Up to 3 years|Data were not collected for Outcome Measure 3 due to study termination (50% enrollment) by the Sponsor on 01 September 2015 due to changing treatment landscape (PD-1 approvals), and a subsequent change in development focus to Immuno-Oncology (IO) combinations. See NCT02439450.||||||
2604792|NCT02117024|Secondary|Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)|Evaluate the safety of the combination of viagenpumatucel-L and low-dose cyclophosphamide by frequency of Treatment-Emergent Adverse Events|Up to 3 years|Safety was defined as the number of adverse events (AE)/serious adverse events (SAE) in patients receiving viagenpumatucel-L and low-dose Cyclophosphamide (CY).|||Participants|||Count of Participants
2604793|NCT02117024|Primary|Overall Survival (OS)|"Overall survival (OS) calculated as the duration of survival from the date of randomization to the date of death from any cause, or was censored on the date the patient was last known to be alive.~Survival time was calculated from the randomization date up to the date of death,or censored on the date that the patient was last known to be alive (last available visit date) utilizing Kaplan-Meier Estimate of Overall Survival Ending Events"|Up to 3 years||||Days||95% Confidence Interval|Median
2604794|NCT02116972|Other Pre-specified|Time to Onset of Pain Relief|Time to onset of pain relief in days is defined as the time from administration of study treatment to the first pain assessment showing >30% improvement from the weekly average daily pain score at baseline.|Baseline up to 24 Weeks after administration of study treatment|Time to onset of pain relief for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported.|||days||95% Confidence Interval|Median
2604795|NCT02116972|Other Pre-specified|Proportion of Patients Experiencing a >20%, 30% and 50% Decrease in Pain From Baseline in Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores at Week 12|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|12 weeks|||||||
2604807|NCT02116803|Primary|Number of Participants With Adverse Events of Grades 3 and 4 Severity|Participants with grades 3 and 4 severity adverse events were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, unless otherwise specified. AEs are provided by System Organ Class (SOC). A patient with multiple adverse events within a primary system organ class was counted only once in the total row.|Until the last patient discontinued dovitinib up to 30 months|Safety set: the Safety set included all patients who received at least one dose of study medication. Safety set was identical to Full Analysis Set for this study.|||Participants|||Count of Participants
2604796|NCT02116972|Other Pre-specified|Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in PGIC|The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.|Baseline and Weeks 4, 8, 16, 20, and 24 (Week 12 data reported in secondary outcome measure)|Change from baseline to each of Weeks 4, 8, 16, 20, and 24 in PGIC for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported.|||units on a scale||Standard Error|Least Squares Mean
2604797|NCT02116972|Other Pre-specified|Change From Baseline to Each of Weeks 4, 8, 12, 16, 20, and 24 in WOMAC-A Pain|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Change from baseline to each of Weeks 4, 8, 12, 16, 20, and 24 in WOMAC-A pain for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported.|||units on a scale||Standard Error|Least Squares Mean
2604798|NCT02116972|Other Pre-specified|Change From Baseline to Each of Weeks 4, 8, 16, 20, and 24 in WOMAC-C-function|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|Baseline and Weeks 4, 8, 16, 20 and 24 (Week 12 data is represented in the secondary outcome measure)|Change from baseline to each of Weeks 4, 8, 16, 20, and 24 in WOMAC-C-function for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported|||units on a scale||Standard Error|Least Squares Mean
2604799|NCT02116972|Other Pre-specified|Change From Baseline to Each Week in Weekly Mean of the ADP Intensity Scores|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine.Weeks 12, 16, 20, and 24 are specified as the primary and secondary endpoints for the 32 mg group and the placebo group"|Baseline and Up to Week 24|Randomized patients who received study drug.|||units on a scale||Standard Error|Least Squares Mean
2604800|NCT02116972|Other Pre-specified|Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC)|The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.|Baseline and Week 12||||units on a scale||Standard Error|Least Squares Mean
2604801|NCT02116972|Other Pre-specified|Change From Baseline to Week 12 for WOMAC C (Function Subscale)|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5- point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|Baseline and Week 12||||units on a scale||Standard Error|Least Squares Mean
2604802|NCT02116972|Other Pre-specified|Percent of Responders According to Outcomes Measures in OMERACT-OARSI Strict Criteria|Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. (OMERACT-OARSI) Responders are defined as participants with high improvement in pain or function.|Weeks 4, 8 and 12|Percent of responders according to Outcomes Measures in OMERACT-OARSI strict criteria for patients assigned to FX006 16 mg arm was not a pre-specified Secondary Outcome and therefore not reported.|||Participants|||Count of Participants
2604803|NCT02116972|Secondary|Change From Baseline to Week 16 and Then Week 20 and Then Week 24 in the Weekly Mean of the Average Daily (24-hour) Pain Intensity Scores|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|Baseline and Weeks 16, 20 and 24|Randomized patients who received study drug.|||units on a scale||Standard Error|Least Squares Mean
2604804|NCT02116972|Secondary|Change From Baseline to Week 12 for Patient Global Impression of Change (PGIC)|The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.|Baseline and Week 12||||units on a scale||Standard Error|Least Squares Mean
2604805|NCT02116972|Secondary|Change From Baseline to Week 12 for WOMAC C (Function Subscale)|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|Baseline and Week 12||||units on a scale||Standard Error|Least Squares Mean
2604806|NCT02116972|Primary|Change From Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hr) Pain Intensity Scores for 32 mg FX006 Versus Placebo|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no painand 10 indicates pain as bad as you can imagine."|Baseline and Week 12|Randomized patients who received study drug assigned to the FX006 32 mg arm and the placebo arm|||units on a scale||Standard Error|Least Squares Mean
2605411|NCT02109640|Primary|Prevalence of Postoperative Gut Dysfunction|The proportion of participants with gut dysfunction, defined as the presence of any of the following sufficient to delay discharge on the 3rd postoperative day: nausea, vomiting, intolerance of oral intake or constipation.|Day 3 post-op||||Participants|||Count of Participants
2604808|NCT02116660|Secondary|Change From Baseline in eGFR at Week 96|Glomerular Filtration Rate (eGFR) was estimated from the Modification of Diet in Renal Disease (MDRD)-6 equation. The MDRD-6 equation = 198 × [serum creatinine(mg/dL)]^−0.858 × [age]−0.167 × [0.822 if patient is female] × [1.178 if patient is black] × [serum urea nitrogen concentration (mg/dL)]^−0.293 × [urine urea nitrogen excretion (g/d)]^0.249.|Baseline and Week 96|Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed.||||||
2604809|NCT02116660|Secondary|Percentage of Participants Experiencing a Decline of Renal Function|Decline in renal function was to be assessed by evaluating MDRD-6, creatinine clearance and serum phosphate.|Up to Week 96|Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed.||||||
2604810|NCT02116660|Secondary|Change From Baseline in the VACS Index|The Veterans Aging Cohort Risk Index (VACS Index) combines various clinical biomarkers into a cumulative index weighted according to the risk of all-cause mortality.|Baseline and week 96|Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed.||||||
2604811|NCT02116660|Secondary|Change From Baseline in Bone Disease Risk Assessment|Bone disease risk assessment was to be based on a Fracture Risk Assessment Tool (FRAX®) score in participants > 40 years old, and the change from baseline determined.|Baseline and week 96|Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed.||||||
2604812|NCT02116660|Secondary|Percentage of Participants With Adherence to Study Therapy|An Adherence Questionnaire was to be given in order to determine the percentage of participants who adhered to study therapy.|Up to Week 96|Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed.||||||
2604813|NCT02116660|Secondary|Percentage of Participants With Genotypic Resistance at Virologic Failure.|Genotypic resistance measures the presence of particular HIV-1 mutations that give rise to drug resistance. Virological failure is defined as 2 consecutive plasma HIV-1 RNA >200 copies/mL at least two weeks apart while on previous or current ARV therapy.|Up to Week 96|Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed.||||||
2604814|NCT02116660|Secondary|Trough Concentration (Ctrough) for Raltegravir and Nevirapine|Blood samples were to be collected in Weeks 12 and 48 in order to use the trapezoidal method to determine the Ctrough, the lowest concentration reached by the drug before the next dose is administered, of Raltegravir and Nevirapine.|Weeks 12 and 48: at the end of dosing interval at 12 h|Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed.||||||
2604815|NCT02116660|Secondary|Area Under the Concentration Time Curve From Time 0 the Last Measurement Time t (AUC0-t) for Raltegravir and Nevirapine|Blood samples were to be collected in Week 12 in order to use the trapezoidal method to determine the AUC0-t of Raltegravir and Nevirapine|Week 12: Fasted state (0 h) and 1, 2, 3, 6 and 12 h post-dose|Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed.||||||
2604816|NCT02116660|Secondary|Percentage of Participants Having Changes From Baseline in Metabolic Bone Markers|Changes from baseline in metabolic bone markers, serum Bone Specific Alkaline Phosphatase (s-BSAP) and C-telopeptides of type 1 Collagen (s-CTx), were to be determined, in order to classify the percentage of participants with changes.|Baseline and up to Week 96|Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed.||||||
2604817|NCT02116660|Secondary|Percentage of Participants With Altered Values of Tubular Kidney Injury Markers.|Values of tubular kidney injury markers. were to be determined, in order to identify the percentage of participants classified with altered values.|Up to Week 96|Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed.||||||
2604818|NCT02116660|Secondary|Percentage of Participants With Altered Liver Enzymes and Lipid Profile|Values of liver enzymes and lipids were to be determined from laboratory tests, in order to identify the percentage of participants classified with altered values.|Up to Week 96|Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed.||||||
2604819|NCT02116660|Secondary|Change From Baseline in Absolute CD4+ T-lymphocyte Count|Cluster of Differentiation 4 + (CD4+) T-lymphocyte cell counts were to be determined at baseline and Week 96, in order to determine the change from baseline.|Baseline and Week 96|Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed.||||||
2604820|NCT02116660|Secondary|Percentage of Participants With Mutations Associated With Resistance to NRTIs, NNRTIs, INI, at Virological Failure.|Participants were to be identified with mutations associated with Nucleoside/ Nucleotide Reverse Transcriptase Inhibitors (NRTIs), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTIs), and Integrase Inhibitor (INI). Virological failure is defined as 2 consecutive plasma HIV-1 RNA >200 copies/mL at least two weeks apart while on previous or current ARV therapy.|Up to Week 96|Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed.||||||
2604821|NCT02116660|Secondary|Change From Baseline of HIV-RNA Absolute Values|Plasma was to be collected at baseline and Week 96 in order to determine the change from baseline in HIV-1 RNA.|Baseline and Week 96|Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed.||||||
2604822|NCT02116660|Secondary|Percentage of Participants With Virologic Failure (HIV-1 RNA > 50 Copies/mL)|Plasma was to be collected up to Week 96 in order to quantify HIV-1 RNA, and identify the percentage of participants with >50 copies/mL HIV-1 RNA.|Up to Week 96|Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed.||||||
2604823|NCT02116660|Secondary|Percentage of Participants With Decline in Renal Function at Week 48|Decline in renal function was to be assessed by evaluating MDRD-6, creatinine clearance and serum phosphate.|Week 48|Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed.||||||
2604825|NCT02116660|Secondary|Percentage of Participants With Suppressed Viremia (<50 Copies/mL HIV-1 Ribonucleic Acid [RNA]) at Week 48|Plasma was to be collected at Week 48 in order to quantify HIV-1 RNA. and identify the percentage of participants with <50 copies/mL HIV-1 RNA.|Week 48|Due to poor enrollment the study was terminated early; therefore data for secondary outcome measures were not collected, and were not analyzed.||||||
2604826|NCT02116660|Primary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)|Glomerular Filtration Rate (eGFR) was estimated from the Modification of Diet in Renal Disease (MDRD)-6 equation. The MDRD-6 equation = 198 × [serum creatinine(mg/dL)]^−0.858 × [age]−0.167 × [0.822 if patient is female] × [1.178 if patient is black] × [serum urea nitrogen concentration (mg/dL)]^−0.293 × [urine urea nitrogen excretion (g/d)]^0.249.|Baseline and Week 48|All randomized participants who received at least one dose of study medications and who had both a baseline assessment, and at least one post-baseline assessment.|||mL/min||Standard Deviation|Mean
2604827|NCT02116621|Other Pre-specified|Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 52 Weeks|Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604828|NCT02116621|Other Pre-specified|Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 52 Weeks|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604829|NCT02116621|Other Pre-specified|Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 52 Weeks|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604830|NCT02116621|Other Pre-specified|Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 52 Weeks|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 52 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604831|NCT02116621|Other Pre-specified|Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 52 Weeks|Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 52 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604832|NCT02116621|Other Pre-specified|Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks|Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 52 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604833|NCT02116621|Other Pre-specified|Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 52 Weeks|Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 52 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604834|NCT02116621|Other Pre-specified|Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 52 Weeks|Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 52 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2626154|NCT01903863|Secondary|Antithrombin Levels|Compared antithrombin levels in neonates in control versus treatment group|ECMO course (median 198 hours)||||percentage of antithrombin||Inter-Quartile Range|Median
2604835|NCT02116621|Other Pre-specified|Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 52 Weeks|Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 52 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604836|NCT02116621|Other Pre-specified|Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks|Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 52 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604837|NCT02116621|Other Pre-specified|Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 52 Weeks|Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline and 52 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.|Baseline, 52 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604838|NCT02116621|Other Pre-specified|Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 13 Weeks|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604839|NCT02116621|Other Pre-specified|Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 13 Weeks|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604840|NCT02116621|Other Pre-specified|Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 13 Weeks|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 13 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604841|NCT02116621|Other Pre-specified|Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 13 Weeks|Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 13 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604842|NCT02116621|Other Pre-specified|Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks|Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604843|NCT02116621|Other Pre-specified|Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 13 Weeks|Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 13 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2605246|NCT02111746|Primary|Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)|"The Brief Pain Inventory (BPI) ranges from 0 (no pain) to 10 (worst pain you can imagine)."|postoperative day 1|Intention-to-treat analysis. Data for this measure was collected for only 142 in the Exparel arm and 140 in the Regular Bupivacaine group.|||units on a scale||Standard Deviation|Mean
2604844|NCT02116621|Other Pre-specified|Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 13 Weeks|Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604845|NCT02116621|Other Pre-specified|Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 13 Weeks|Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 13 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604846|NCT02116621|Other Pre-specified|Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks|Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 13 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604847|NCT02116621|Other Pre-specified|Change From Baseline in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 13 Weeks|Pain-related interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item short form at baseline and 13 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.|Baseline, 13 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604848|NCT02116621|Other Pre-specified|Change From Baseline in Participatory Decision-making on the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Surveys at 26 Weeks|Four questions from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey assessed patient-provider discussions on starting/stopping medications and comprise medication related shared decision making. Scores were computed only for patients who reported discussing medications with their clinician in the past 12 months. Medication related shared decision making scores range from 0-100. Higher scores indicate more shared decision making.|26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604849|NCT02116621|Other Pre-specified|Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Medication at 26 Weeks|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604850|NCT02116621|Other Pre-specified|Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Medical Care at 26 Weeks|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604851|NCT02116621|Other Pre-specified|Change From Baseline on the Pain Treatment Satisfaction Scale (PTSS) - Satisfaction With Pain Information at 26 Weeks|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline and 26 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604852|NCT02116621|Other Pre-specified|Change From Baseline in Patient-provider Relationship on the Trust in Physician Scale at 26 Weeks|Patient trust in physician measured with 11-item Trust in Physician Scale at baseline and 26 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604853|NCT02116621|Other Pre-specified|Change From Baseline in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks|Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604854|NCT02116621|Other Pre-specified|Change From Baseline in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire at 26 Weeks|Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline and 26 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604855|NCT02116621|Other Pre-specified|Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale at 26 Weeks|Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604856|NCT02116621|Other Pre-specified|Change From Baseline on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale at 26 Weeks|Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline and 26 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604857|NCT02116621|Other Pre-specified|Change From Baseline in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks|Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline and 26 weeks, which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.|Baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604858|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Medication|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales. Satisfaction with current pain medication is a subscale that includes 8 questions assessing current pain medications. Satisfaction with pain medication scores range from 0-100. Higher scores indicate greater patient satisfaction with current pain medications. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain medications and negative numbers indicating declines in satisfaction with pain medications.|Baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
2604859|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Medical Care|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, 52 weeks, creating three subscales. Satisfaction with medical care is a subscale that includes 5 questions assessing medical care for pain. Satisfaction with medical care scores range from 0 - 100. Higher scores indicate greater patient satisfaction with medical care. Data table measures show change over time with positive numbers indicating increases in satisfaction with medical care and negative numbers indicating declines in patient satisfaction.|Baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
2604860|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Pain Treatment Satisfaction Scale (PTSS) -Satisfaction With Pain Information|The Pain Treatment Satisfaction Scale consists of 18 items assessing patient satisfaction at baseline, 13 weeks, 26 weeks, and 52 weeks, creating three subscales. Satisfaction with pain information is a subscale that includes 5 questions assessing information about pain and its treatment. Satisfaction with pain information range from 0-100. Higher scores indicate greater patient satisfaction with information received about pain and treatment for pain. Data table measures show change over time with positive numbers indicating increases in satisfaction with pain information and negative numbers indicating declines in patient satisfaction.|Baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
2604861|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up in Patient-provider Relationship on the Trust in Physician Scale|Patient trust in physician measured with 11-item Trust in Physician Scale at baseline, 13 weeks, 26 weeks, and 52 weeks to assess the quality of the patient-clinician relationship. Trust in physician scores range from 0 - 100. Higher scores indicate greater patient trust in the clinician providing pain treatment. Data table measures show change over time with positive numbers indicating increases in trust and negative numbers indicating declines in trust.|baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
2604862|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Underuse) on the Pain Medication in Primary Care Patient Questionnaire|Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks. Two questions comprised a subscale assessing underuse of medications. Underuse scores range from 0-100. Higher scores indicate greater adherence and less underuse of medication. Data table measures show change over time with positive numbers indicating greater adherence (less underuse of medications) and negative numbers indicating less adherence.|baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
2604863|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up in Analgesic Adherence (Overuse) on the Pain Medication in Primary Care Patient Questionnaire|Four questions from the Pain Medication in Primary Care Patient Questionnaire measured adherence to medications at baseline, 13 weeks, 26 weeks, 52 weeks. Two questions comprised a subscale assessing overuse of medications. Overuse scores range from 0 - 100. Higher scores indicate greater adherence and less overuse of medications. Data table measures show change over time with positive numbers indicating greater adherence (less overuse of medications) and negative numbers indicating less adherence.|Baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
2604864|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) PHYSICAL Global Health Scale|Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, 52 weeks, representing physical and mental health components. Global physical health measures overall physical health, physical function, pain and fatigue. The final physical health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Physical global health scores range from 0 - 100, and higher scores indicate better physical health. Data table measures show change over time with positive numbers indicating improvement in global physical health and negative numbers indicating declines in global physical health.|baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
2604865|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up on the Patient-Reported Outcomes Measurement Information System (PROMIS) MENTAL Global Health Scale|Global health measured with 10 item Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health scale at baseline, 13 weeks, 26 weeks, and 52 weeks, representing physical and mental health components. Global mental health measures mental health, quality of life, satisfaction with social activities and emotional problems. The final mental health score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Global mental health scores range from 0 - 100, and higher scores indicate better mental health. Data table measures show change over time with positive numbers indicating improvement in global mental health and negative numbers indicating declines in global mental health.|baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
2604866|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain Intensity on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale|Pain intensity measured with Patient-Reported Outcomes Measurement Information System (PROMIS) 3a short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported estimate of how much a person hurts. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain intensity scores range from 0 - 100. For pain intensity, higher scores indicate greater pain intensity. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain intensity.|baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
2604875|NCT02116530|Secondary|Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire|Patients were asked to record daily levels of undesired sedation and appetite increase using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).|Baseline and day 2 to 6 days after chemotherapy|All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had toxicities data at each time point.|||units on a scale||Standard Deviation|Mean
2604936|NCT02115386|Secondary|Number of Participants With a Major Molecular Response|MMR was defined as a ≥ 3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤ 0.1 % BCR-ABL/ABL % by international scale as measured by RQ-PCR, confirmed by duplicate analysis of the same sample. Molecular response was described for all time points except screening where response was estimated.|Months 1, 3, 6, early termination||||participants|||Number
2604867|NCT02116621|Secondary|Longitudinal Change From Baseline up to 52 Weeks Follow-up in Pain-related Interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale|Pain-related Interference measured with Patient-Reported Outcomes Measurement Information System (PROMIS) scale 8-item short form at baseline, 13 weeks, 26 weeks, and 52 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.|baseline, 13 weeks, 26 weeks, 52 weeks|Longitudinal analysis at baseline, 13, 26 and 52 weeks; numbers reported are adjusted means from a mixed effect Gaussian model using time, treatment and time*treatment interaction as fixed effects and clinician and patient as random effects.|||units on a scale||95% Confidence Interval|Least Squares Mean
2604868|NCT02116621|Primary|Change From Baseline in Pain-related Interference on the Patient Reported Outcomes Measurement Information System (PROMIS) Scale at 26 Weeks|Pain interference measured with Patient Reported Outcomes Measurement Information System (PROMIS) Scale 8-item short form at baseline and 26 weeks which measures self-reported consequences of pain on relevant aspects of one's life. The final score is represented by the T-score, a standardized score with a mean of 50 and a standard deviation of 10. Pain interference scores range from 0 - 100. For pain interference, higher scores indicate greater pain interference. Data table measures show change over time with negative numbers indicating improvement (decreases) and positive numbers indicating increases in pain interference.|baseline, 26 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2604869|NCT02116582|Secondary|Number of Participants With Adverse Events (AEs)|A treatment-emergent adverse event (TEAE) was defined as an adverse event occurring or worsening between the start of study treatment date and the latest date of 30 days after the last dose date or the 30-day follow-up visit date, and not later than the data cut-off date or the date of death. AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) guidelines (V4.03).|From the first dose of study drug administration up to data cut-off date for end-of-study completion (29 Sep 2017); the median duration of treatment was 5.7 months.|The analysis population consisted of the SAF.|||Participants|||Number
2604870|NCT02116582|Secondary|Time to PSA Progression|The time to PSA progression was calculated as the time interval from the date of first dose to the date of first observation of PSA progression. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 μg/L (i.e., 2 ng/mL or more) above the nadir or above the baseline value for patients who did not have a decline in PSA postbaseline values, and which was confirmed by a second consecutive value obtained at least 3 or more weeks later (i.e., a confirmed rising trend) (PCWG2 criteria). The 50th percentile of KM estimates was used as the estimate of the time to PSA progression median. A 2-sided 95% CI was provided for this estimate using the BC method.|From the first dose of study drug administration up to the data cut-off date of 08 May 2016; the median duration of treatment was 5.7 months.|The analysis population consisted of the SAF.|||Months||95% Confidence Interval|Median
2604871|NCT02116582|Secondary|Percentage of Participants With a Prostate-specific Antigen (PSA) Response|PSA response was defined as at least a 50% decrease from baseline in PSA, and was a binary variable for achieving this criteria (or not) based on the lowest PSA value observed postbaseline. Participants with no postbaseline PSA value were regarded as non-responders. 95% CI for PSA response rate was computed using the Clopper-Pearson method based on the exact binomial distribution.|From the first dose of study drug administration up to the data cut-off date for end-of-study completion 29 Sep 2017; the median duration of treatment was 5.7 months.|The analysis population consisted of the SAF.|||Percentage of participants||95% Confidence Interval|Number
2604872|NCT02116582|Secondary|Overall Survival (OS)|OS was defined as the time from first dose to death from any cause. All events of death were included. If patients discontinued study drug before the analysis data cut-off point, only OS status was assessed every 12 weeks until the data cut-off point date or until death, whichever occurred first. For patients who were alive at the time of the analysis data cut-off point, the OS time was censored on the last date the patient was known to be alive. Death from any cause was included, regardless of whether the event occurred while the patient was still taking study drug or after the patient discontinued study drug. OS median was estimated using the KM method. A 2-sided 95% CI was provided for this estimate using the BC method.|From the first dose of study drug administration up to the data cut-off date of 08 May 2016; up to 2 years.|The analysis population consisted of the SAF.|||Months||95% Confidence Interval|Median
2604873|NCT02116582|Primary|Radiographic Progression-free Survival (rPFS)|Radiographic PFS, was defined as the time from first dose to the first objective evidence of radiographic disease progression or death from any cause, whichever occurred first. For patients with no documented progression event, it was censored on the date of the last disease assessment performed prior to the analysis data cut-off point. Radiographic progression (RP) for soft tissue disease was defined by Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria. RP for bone disease was determined according to the consensus guidelines of a modification of the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) guidelines. The 50th percentile of Kaplan-Meier (KM) estimates was used as the estimate of the rPFS median. A 2-sided 95% Confidence Interval (CI) was provided for this estimate using the Brookmeyer & Crowley (BC) method.|From the first dose of study drug administration up to treatment discontinuation or the data cut-off date of 08 May 2016, whichever occurred first; the median duration of treatment was 5.7 months.|The analysis population consisted of the safety analysis set (SAF) which consisted of all participants who took at least 1 dose of study drug.|||Months||95% Confidence Interval|Median
2604874|NCT02116530|Secondary|Frequency of Rescue Medication|Patients were asked to record daily number of extra nausea/vomiting pills taken because they developed nausea/vomiting in the following categories: None, One, Two, More than two in Nausea and Vomiting Daily Diary Questionnaire.|Day 2 to Day 6 after chemotherapy|All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had rescue medication data at each time point.|||Participants|||Count of Participants
2604933|NCT02115386|Secondary|Lisiting by Participant of EORTC-QLQ-C30 for Quality of Life|EORTC-QLQ-C30 was administered to evaluate quality of life changes after switching to nilotinib. Scores ranged from 1 (very poor) to 6 (excellent)|Screening, months 1, 3, 6, after switch to nilotinib||||score|||Number
2604876|NCT02116530|Secondary|Proportion of Patients With Complete Response|Complete response was defined as no emetic episodes and no use of rescue medication during the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods as measured by the Nausea and Vomiting Daily Diary/Questionnaire.|0 to 120 hours after chemotherapy|All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had data on emetic and use of rescue medication questions.|||percentage of participants|||Number
2604877|NCT02116530|Secondary|Median Nausea Scores|Nausea scores was measured using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).|Baseline and Day 2 to Day 6 after chemotherapy|All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had Nausea data at each time point.|||units on a scale||Full Range|Median
2604878|NCT02116530|Primary|Proportion of Patients With no Nausea|No nausea was defined as a response of 0 in the nausea item of Nausea and Vomiting Daily Diary/Questionnaire in the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods after chemotherapy.|0 to 120 hours after chemotherapy|All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had Nausea data.|||percentage of participants|||Number
2604879|NCT02116361|Secondary|Change From Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)|The HAM-D17 is assessed by the clinician based on subject interview. The total scores range from 0 to 53. A higher total score indicates more severe depression. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.|24 Weeks|Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point|||Scores on a Scale||Standard Error|Least Squares Mean
2604880|NCT02116361|Secondary|Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17)|The HAM-D17 is assessed by the clinician based on subject interview. The total scores range from 0 to 53. A higher total score indicates more severe depression. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.|Baseline|Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point|||Scores on a Scale||Standard Deviation|Mean
2604881|NCT02116361|Secondary|Change From Baseline Values in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score|The CGI-S is a 7-point scale assessed by the clinician to rate the severity of the subject's symptoms. Scores range from 1 to 7, from normal (1, not at all ill) to among the most extremely ill patients (7). A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.|24 Weeks|Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point|||Scores on a Scale||Standard Error|Least Squares Mean
2604882|NCT02116361|Secondary|Baseline Values for the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score|The CGI-S is a 7-point scale assessed by the clinician to rate the severity of the subject's symptoms. Scores range from 1 to 7, from normal (1, not at all ill) to among the most extremely ill patients (7). A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.|Baseline|Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point|||Scores on a Scale||Standard Deviation|Mean
2604883|NCT02116361|Primary|Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.|Week 6|Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point|||Scores on a Scale||Standard Error|Least Squares Mean
2604884|NCT02116361|Primary|Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening.|Baseline|Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point|||Scores on a Scale||Standard Deviation|Mean
2604885|NCT02116322|Secondary|Diagnostic Yield of the FNA Using Corkscrew Technique|Diagnostic yield was defined as the proportion of masses in which the amount of FNA-obtained cellular material was enough for the histopathologist to make the pathological diagnosis.|30 days||||percentage of masses|||Number
2604886|NCT02116322|Primary|Number of Participants With Adverse Events as a Measure of Safety||30 days||||participants|||Number
2604887|NCT02116309|Secondary|Number of Patients Who Developed Severe Post-ERCP Pancreatitis|Severity of PEP defined using the consensus grading as Mild PEP that results in hospitalization (or prolongation of existing hospitalization) for ≤3 days. Moderate PEP will be defined as PEP that results in hospitalization (or prolongation of existing hospitalization) for 4-10 days. Severe PEP will be defined as PEP that results in hospitalization (or prolongation of existing hospitalization) for > 10 days, or leads to the development of pancreatic necrosis or pseudocyst, or requires additional endoscopic, percutaneous, or surgical intervention.|up to 30 days after ERCP||||Participants|||Count of Participants
2604888|NCT02116309|Primary|Number of Patients Who Developed Post-ERCP Pancreatitis|The primary outcome variable of interest is the incidence of post ERCP pancreatitis (PEP) as defined by the consensus guidelines as 1) New or increased abdominal pain that is clinically consistent with a syndrome of acute pancreatitis and 2) amylase or lipase ≥ 3x the upper limit of normal 24 hours after the procedure and 3) Hospitalization or prolongation of existing hospitalization for at least 2 days.|24 hours after ERCP||||Participants|||Count of Participants
2604889|NCT02115984|Primary|The Quantity of Leukocytes and Neutrophils in the Blood of Patients||Baseline, Day 21 after 2nd chemotherapy (Day 42 post-baseline), Day 21 after 3rd chemotherapy (Day 63 post-baseline)||||10^9 cells/L||Inter-Quartile Range|Median
2604937|NCT02115386|Secondary|Number of Participants With Complete Cytogenetic Response (CCyR)|Cytogenetic response will be assessed as the percentage of Ph+ metaphases in the bone marrow and is defined as the following: Complete (CCyR) - 0% Ph+ metaphases.|at months 6,12 and 24 after switching from imatinib to nilotinib||||participants|||Number
2604890|NCT02115828|Secondary|The Effect of Vismodegib on PSA Responses|The effect of vismodegib on PSA responses will be assessed as the number of patients with participants with ≥50% PSA reductions at any time point during study|Up to 1 Year|Seven patients were evaluable for PSA response. One participant had no measurable PSA production at enrollment, and PSA remained <0.01 throughout the study. A second patient had disease progression prior to the first on-study PSA evaluation.|||participants|||Number
2604891|NCT02115828|Secondary|AKT1 Expression in Tumor Biopsies|The tumor biopsies were evaluated for changes to Hh-regulated transcript, AKT1, between pre-treatment and post-treatment|Up to 1 Year|One patient did not receive a post-treatment biopsy, and another patient had insufficient tissue for evaluation from the repeat biopsy|||expression fold change||Full Range|Median
2604892|NCT02115828|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined by the Prostate Cancer Working Group 2 (PCWG2) criteria using RECIST 1.1 criteria for each patient. PFS is defined as the time of first dose (a) until prostate specific antigen (PSA) progression (by 25% increase in PSA from nadir) or death and (b) until any evidence of progression (by 25% increase in PSA from nadir, a new lesion on bone or CT scan, or physical examination) or death. PFS will be assigned to the earliest observed time.|Up to 1 Year||||months||95% Confidence Interval|Median
2604893|NCT02115828|Secondary|GLI1 Expression|Suppression by vismodegib in tumor tissue of Hh-regulated transcripts and proteins was defined as the change from baseline in expression levels of GLI1 in situ tissue expression by mRNA in situ hybridization.|Up to 1 Year|One patient did not receive a post-treatment biopsy, and another patient had insufficient tissue for evaluation from the repeat biopsy|||expression fold change||Full Range|Median
2604894|NCT02115828|Primary|The Proportion of mCRPC Patients Treated With Vismodegib Who Achieve a Pharmacodynamic (PD) Response in Tumor Biopsies|The primary endpoint is the proportion of mCRPC patients treated with vismodegib who achieve a pharmacodynamic (PD) response in tumor biopsies, defined as both a decrease in GLI1 mRNA greater than 1.2 times the standard deviation (SD) of the baseline values and a ≥50% (≥2-fold) reduction in GLI1 messenger ribonucleic acid (mRNA) expression in metastatic tumor biopsies after 4 weeks of treatment when comparing post-treatment biopsy to pre-treatment biopsy in the same patient.|Up to 1 year|The design had 90% power to detect a true 65% PD response rate across patients, with a false-positive rate of 3.3% under the null hypothesis that vismodegib has no effect in downregulating Gli1 expression.|||Participants|||Count of Participants
2604895|NCT02115815|Secondary|Percentage of Participants Who Experience a Post-dose 3-fold Cell-mediated Immune Response to RSV F on Day 8|Seroresponse defined as a greater than or equal to (>=) 3-fold rise from baseline|Day 8|Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result.|||percentage of participants||95% Confidence Interval|Number
2604896|NCT02115815|Secondary|Post-dose Geometric Mean Fold Rises (GMFRs) of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT)|The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides.|Day 8 and 29|"Immunogenicity population included participants in ATP who had no protocol deviation judged to have potential to interfere with generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, N and 'n' is number of participants analysed for this outcome measure and at given time points, respectively."|||fold rise||95% Confidence Interval|Geometric Mean
2604897|NCT02115815|Secondary|Post-dose Geometric Mean Counts (GMCs) From Baseline of T Cell Response Against Respiratory Syncytial Virus (RSV) by RSV F Enzyme-Linked Immunospot (ELISPOT)|The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides.|Baseline (Day 1), Day 8 and 29|"Immunogenicity population included participants in ATP who had no protocol deviation judged to have potential to interfere with generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, N and 'n' is number of participants analysed for this outcome measure and at given time points, respectively."|||spot forming counts per 10^6 PBMCs||95% Confidence Interval|Geometric Mean
2604898|NCT02115815|Secondary|Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay|Seroresponse defined as a greater than or equal to (>=) 4-fold rise from baseline.|Day 29|Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result.|||percentage of participants||95% Confidence Interval|Number
2604899|NCT02115815|Secondary|Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay|Anti F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform.|Day 29, 61, 91, 181, 271 and 361|"Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, n is number of participants analysed for this outcome measure at give time points."|||fold rise||95% Confidence Interval|Geometric Mean
2604900|NCT02115815|Secondary|Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by Anti-Fusion Protein (F) Immunoglobulin G (IgG) Assay|Anti F IgG antibodies were determined by a multiplex IgG assay developed on the Meso Scale discovery platform.|Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361|"Immunogenicity population included participants in ATP who had no protocol deviation judged to have potential to interfere with generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, n is number of participants analysed for this outcome measure at give time points."|||titer||95% Confidence Interval|Geometric Mean
2604901|NCT02115815|Secondary|Percentage of Participants Who Experience a Post-dose Seroresponse to Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay|Seroresponse defined as a greater than or equal to (>=) 4-fold rise from baseline.|Day 29|Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result.|||percentage of participants||95% Confidence Interval|Number
2604902|NCT02115815|Secondary|Post-dose Geometric Mean Fold Rises (GMFRs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay|RSV neutralizing antibody titers were measured using green fluorescent protein tagged RSV A 2.|Day 29, 61, 91, 181, 271 and 361|"Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, n is number of participants analysed for this outcome measure at give time points."|||fold rise||95% Confidence Interval|Geometric Mean
2604903|NCT02115815|Secondary|Post-dose Geometric Mean Titers (GMTs) From Baseline of Serum Antibodies Against Respiratory Syncytial Virus (RSV) by RSV A Microneutralization Assay|RSV neutralizing antibody titers were measured using green fluorescent protein tagged RSV A 2|Baseline (Day 1), Day 29, 61, 91, 181, 271 and 361|"Immunogenicity population included participants in the As-treated population who had no protocol deviation judged to have the potential to interfere with the generation or interpretation of an immune response, and had baseline and/or any post-baseline result. Here, n is number of participants analysed for this outcome measure at give time points."|||titer||95% Confidence Interval|Geometric Mean
2604904|NCT02115815|Primary|Number of Participants With Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs) and Treatment-Emergent New Onset Chronic Disease (NOCDs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study product and Day 361 that were absent before treatment or that worsened relative to pretreatment state. An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving investigational product and was assessed by investigator as medically significant.|From Day 1 to Day 361|As-treated Population (ATP) included participants who received any study investigational product.|||participants|||Number
2604905|NCT02115815|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study product and Day 361 that were absent before treatment or that worsened relative to pretreatment state.|From Day 1 to Day 28|As-treated Population (ATP) included participants who received any study investigational product.|||participants|||Number
2604906|NCT02115815|Primary|Number of Participants With Solicited Symptoms|Solicited symptoms: tenderness or soreness at site of injection, pain at site of injection, fatigue or tiredness, headache, generalized muscle aches, swelling at the site of injection, redness at the site of injection, fever greater than or equal to (>=) 100.4 degrees F by any route from Day 1 to Day 7.|Day 1 to Day 7|As-treated Population (ATP) included participants who received any study investigational product.|||participants|||Number
2604907|NCT02115750|Secondary|Summary of Change in Physician's Global Assessment- Visual Assessment Scale (PGA-VAS) by Study Visit|"The score range for PGA-VAS is 0-100 millimeters. The patient's assessment of disease activity - with the lowest score on the left side representing none to the highest score on the right side representing extremely active."|Weeks 4,8,12,18,24,28,36,48|The full analysis population differs between part one (weeks 0 to 24) and part two (weeks 25 to 48) because part two does not include the full population that began the study.|||Units on a Scale||Standard Deviation|Mean
2604908|NCT02115750|Secondary|Summary of Change in Subject's Pain Assessment - Visual Analog Scale (SPA-VAS) by Study Visit|The score range for the SPA-VAS is 0-100 millimeters. One total score was reported for each assessment, no subscales exist. A lower score on the left side represents a better outcome (less pain) and the higher score is on the right side representing a worse outcome (more pain).|Weeks 4,8,12,18,24,28,36,48|The full analysis population differs between part one (weeks 0 to 24) and part two (weeks 25 to 48) because part two does not include the full population that began the study.|||Units on a scale||Standard Deviation|Mean
2604909|NCT02115750|Secondary|Summary of Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Study Visit|"HAQ-DI - Scales for each question range from 0-3 (0=without any difficulty; 1=with some difficulty; 2=with much difficulty; 3=Unable to do). The total for each category is determined by the highest score (greatest difficulty) for that category. The score for the disability index is the mean of the eight category scores. If more than 2 of the categories or 25% are missing, the scale won't be scored. If fewer than 2 or the categories are missing, the sum of the categories was divided by the number of answered categories."|Weeks 4,8,12,18,24,28,36,48|The full analysis population differs between part one (weeks 0 to 24) and part two (weeks 25 to 48) because part two does not include the full population that began the study.|||Units on a Scale||Standard Deviation|Mean
2604910|NCT02115750|Secondary|Summary of Change in Swollen Joint Count (SJC) by Study Visit|The 66/68 Joint Count evaluates 66 joints for swelling. The temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), distal interphalangeal (DIP), hip, knee, ankle, tarsus, metatarsophalangeal (MTP), and interphalangeal of the feet are included in this joint count.|Weeks 4,8,12,18,24,28,36,48|The full analysis population differs between part one (weeks 0 to 24) and part two (weeks 25 to 48) because part two does not include the full population that began the study.|||Joints||Standard Deviation|Mean
2604934|NCT02115386|Secondary|Time to First Improvement of Persistant Chronic Low-grade Non-hematologic AEs at 24 Months After Switch From Imatinib to Nilotinib|Evaluate time to first improvement of low-grade non-hematologic adverse events, experienced by patients treated with imatinib and persistent despite of best supportive measures after switching to nilotinib therapy. Optimal improvement is defined as AE grade decreasing to 0.|first improvement of AEs after switch to 24 Months|No data collected for this assessment, as no participants reached month 24||||||
2604911|NCT02115750|Secondary|Summary of Change in Tender Joint Count (TJC) by Study Visit|The average percent improvement from baseline in individual ACR response criteria: TJC (Tender joint count) the 66/68 Joint Count evaluates 68 joints for tenderness and pain with movement. The temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), distal interphalangeal (DIP), hip, knee, ankle, tarsus, metatarsophalangeal (MTP), and interphalangeal of the feet are included in this joint count. Hip joints can be evaluated for tenderness.|Weeks 4,8,12,18,24,28,36,48|The full analysis population differs between part one (weeks 0 to 24) and part two (weeks 25 to 48) because part two does not include the full population that began the study.|||Joints||Standard Deviation|Mean
2604912|NCT02115750|Secondary|ACR20 - (20% Improvement According to American College of Rheumatology Criteria) at Weeks 4, 8, 12, and 18|"Subjects were considered an ACR20 responder if, when compared to baseline (last non-missing value prior to first dose), they achieved a 20% decrease in SJC, 20% decrease in TJC, and 20% improvement in 3 of the following 5 measures:~High sensitivity C-reactive protein (hs-CRP);~Health Assessment Questionnaire-Disability Index (HAQ-DI);~Subject's global assessment of pain (ie, subject's pain assessment [SPA]-visual analog scale [VAS]);~Subject's global assessment of disease activity (SGA-VAS); and~Physician's global assessment of disease activity (PGA-VAS).~In these calculations, the percent change from baseline to endpoint was used to determine ACR20. For percentage change calculations, results were rounded to 5 decimal places prior to comparing to the threshold of 20%.For SJCs and TJCs, the assessment of efficacy was based on mean change from baseline (last non-missing value prior to first dose evaluation)."|Weeks 4, 8, 12 and 18||||percentage of participants|||Number
2604913|NCT02115750|Primary|ACR-20 - 20% Improvement According to American College of Rheumatology Criteria|The primary efficacy endpoint in Part 1 was the percentage of subjects who achieved ACR20 (20% improvement according to American College of Rheumatology criteria) at week 24 compared to baseline (last non-missing value prior to first dose). Subjects were considered an ACR20 responder if when compared to baseline (last non-missing value prior to first dose), they achieved a 20% decrease in SJC (Swollen joint count), 20% decrease in TJC (Tender joint count), and 20% improvement in 3 of the following 5 measures: high sensitivity C reactive protein(hs-CRP), Health Assessment Questionnaire Disability Index(HAQ-DI), subjects global assessment of pain(SPA, VAS), subject's global assessment of disease activity(SGA-VAS), physician's global assessment of disease activity(PGA-VAS)|24-weeks||||Participants|||Count of Participants
2604914|NCT02115646|Secondary|POSAS|The Patient and Observer Scar Assessment Scale (POSAS) is a validated scale that measures both the patient assessment and the observer assessment on the quality (height, color, stiffness, thickness, symptoms, relief, surface area) of the scar. Scores range from 0-60, with 60 being the worst quality of scar.|Baseline and 15 months|All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.|||units on a scale||Standard Error|Mean
2604915|NCT02115646|Secondary|Quality of Life|The 36-Item Short Form Survey (SF-36) is a validated quality of life measurement tool. It measures 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. It is scored on a 0-100 scale, with 100 being the least bothersome to quality of life.|Baseline and 15 months|All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.|||units on a scale||Standard Deviation|Mean
2604916|NCT02115646|Primary|Scar Thickness|This is an ultrasound measurement using the Dermascan Cyberderm to measure the thickness of the scar at baseline in millimeters.|Baseline and 15 months|All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.|||mm||Standard Deviation|Mean
2604917|NCT02115646|Primary|Scar Elasticity, Baseline vs 15-months|This is the measure of the elasticity of the scar using a Torque-meter. It is measured on a 0-1 unit scale, with 0 being normal skin elasticity and 1 being completely inelastic.|Baseline and 15 months|All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.|||units on a scale||Standard Deviation|Mean
2604918|NCT02115646|Primary|Scar Pigmentation, Baseline vs 15-months|Using the colorimeter, will measure change in pigmentation of the scar at the conclusion of the study. This tool measures the pigment in a scar, with a possible range of 0-100, with 100 being the darkest hyperpigmentation, and 0 being no hyperpigmentation.|Baseline and 15 months|All subjects who completed the study (1 baseline visit, 3 fractionated CO2 laser treatments, 1 exit visit) were evaluated.|||units on a scale||Standard Deviation|Mean
2604919|NCT02115633|Secondary|Activities-Specific Balance Confidence Scale (ABC)|Powell and Myers (1995) developed the Activities-specific Balance Confidence (ABC) Scale to detect levels of balance confidence in elderly persons. The ABC scale is a one-page questionnaire that asks questions about balance confidence when performing 16 different tasks. The items are rated on a scale of 0 to 100; a score of 0 indicates no confidence and a score of 100 indicates complete confidence when performing the task. The overall score is calculated by adding the individual items then dividing by the total number of items (16). The higher the score, the greater the person's balance confidence; thus, higher scores indicate that subjects are more confident of their balance. The ABC Scale was assessed only at baseline to document the level of balance confidence the subjects had before beginning the study intervention.|Measure was administered only at baseline during one test session <3 hours.||||score on a scale of 0-100||Standard Deviation|Mean
2604920|NCT02115633|Secondary|10-Meter (10M) Walk Test (Measure of Gait Speed)--Number of Participants With Improvement to Normal Gait Speed|The 10m-walk is routinely done in rehabilitation and has excellent reliability in chronic stroke patients. In addition, gait speed has been found to be an important predictor of survival in older adults (Hardy, Perera et al. 2006), further emphasizing its importance as a clinical outcomes measure. Gait speed (10-meter walk, timing only the middle 6 meters to allow for acceleration and deceleration) was assessed by instructing subjects to walk at their normal speed. A difference of 0.10m/sec is defined as the Minimally Clinical Important Difference (MCID) (Perera, Mody et al. 2006). Lower scores (# of seconds) on this measure indicate a better outcome. To be included in the count of participants, subjects' times on the 10M Walk Test needed to improve by more than 0.10m/sec, the MCID.|During one test session < 3 hours||||Participants|||Count of Participants
2604921|NCT02115633|Secondary|Four-Stage Balance Test >30s|The 4-Stage Balance Test is part of the STEADI protocol recommended by the Centers for Disease Control and Prevention (CDC) to assess fall-risk in elderly individuals. It includes four gradually more challenging postures the subject performs; 1) Stand with feet side by side; 2) Stand with feet in semi-tandem stance; 3) Stand with feet in tandem stance; 4) Stand on one leg. Subjects pass if they can hold the stance for 10 seconds and then move on to the next stance. A fail during tasks 1, 2, or 3 indicates a high risk of falling, i.e., a total performance time of less than 30 seconds.|The assessment requires holding each stance for 10 seconds for a total of 40 seconds to pass.||||number of seconds stances held||Standard Deviation|Mean
2604922|NCT02115633|Primary|Functional Gait Assessment (FGA)|The Functional Gait Assessment (FGA) is a reliable and valid measure of gait function related to postural stability and has been shown to be effective in classifying fall risk in older adults and predicting unexplained falls in community-dwelling older adults (Wrisley, Marchetti et al. 2004; Wrisley and Kumar 2010). It has also been validated in stroke survivors (Lin, Hsu et al. 2010) and patients with Parkinson's disease (Leddy, Crowner et al. 2011) and has less flooring and ceiling effect than the Dynamic Gait Index (Lin, Hsu et al. 2010). The FGA includes a 10-item scale; each item is scored from 0 to 3 (3=normal, 2=mild impairment, 1=moderate impairment, 0=severe impairment). The maximum score is 30; minimum score, 0. Higher scores represent a better outcome. To be included in the count of participants, subjects' FGA scores needed to improve more than 4 points, which is the Minimally Clinically Important Difference (MCID) (Beninato et al. 2014).|During one test session < 3 hours||||Participants|||Count of Participants
2604923|NCT02115607|Secondary|SHI Depiction of Breast Cancer Angiogenesis for Partial Responders|To compare the 3D SHI depiction of breast cancer angiogenesis in humans to CD31, an immunohistochemical predictor of angiogenesis.|After surgery; on average 6 months|Data presented below is for those who achieved Partial Response (PR)|||dB||Standard Deviation|Mean
2604924|NCT02115607|Secondary|Subharmonic Imaging (SHI) Depiction of Breast Cancer Angiogenesis for Complete Responders|To compare the 3D Subharmonic imaging (SHI) depiction of breast cancer angiogenesis in humans to CD31, an immunohistochemical predictor of angiogenesis.|From baseline to after surgery|six participants were not counted in the data analysis. 2 due to technical issues, 2 withdrew due to worsening of underlying disease, and 2 stopped their nedoadjuvant chemotherapy treatment unexpectedly. Data presented below is for those who achieved Complete Response (CR)|||dB||Standard Deviation|Mean
2604925|NCT02115607|Primary|Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Partial Responders|To evaluate the ability of SHAPE, used with Definity, to track changes in interstititial fluid (IFP) by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% 30% of the neoadjuvant chemotherapy treatment delivered and after completion of the neoadjuvant chemotherapy treatment and comparing results to MRI and pathology.|from baseline to completion of neoadjuvant chemotherapy|six participants were not counted in the data analysis. 2 due to technical issues, 2 withdrew due to worsening of underlying disease, and 2 stopped their nedoadjuvant chemotherapy treatment unexpectedly. Data presented below is for those who achieved Partial Response (PR)|||dB||Standard Deviation|Mean
2604926|NCT02115607|Primary|Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Complete Responders|To evaluate the ability of SHAPE, used with Definity, to track changes in interstitial fluid pressure (IFP) by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% and 30% of the neoadjuvant chemotherapy treatment delivered and comparing results to MRI and pathology.|from baseline to completion of neoadjuvant chemotherapy, average of 6 months|six participants were not counted in the data analysis. 2 due to technical issues, 2 withdrew due to worsening of underlying disease, and 2 stopped their nedoadjuvant chemotherapy treatment unexpectedly. Data presented below is for those who achieved Complete Response (CR)|||dB||Standard Deviation|Mean
2604927|NCT02115581|Primary|Improvement in Left Ventricular Filling Abnormality|Doppler-derived transmitral blood flow and pulmonary venous blood flow data were used for grading of the severity of diastolic filling abnormality in patients before and after the intervention. Diastolic filling abnormality was categorized as: 1- normal 2- abnormal relaxation 3- pseudonormal 4- restricted pattern based on echo data. The proportion of patients who showed improvement in the diastolic function grading was compared between the study groups.|6 months||||Percentage|||Number
2604928|NCT02115581|Primary|Improvement in Left Ventricular Ejection Fraction|Ejection Fraction of left ventricle (percentage of blood pumped out of left ventricle with each heart beat) calculated by echocardiography|6 months||||Percentage||Standard Deviation|Mean
2604929|NCT02115581|Secondary|Adverse Events|Number of patients with evidence of adverse reaction to coenzyme Q10 including nausea, vomiting, changes in blood pressure, neurological signs or any abnormal behavior like disquiet in young children.|6 months||||Participants|||Number
2604930|NCT02115542|Secondary|Progression Free Survival (PFS)|"PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.~Progression - One or more of the following must occur: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site."|Post 6 months follow-up, up to 13 months from on treatment per participant||||months||95% Confidence Interval|Median
2604931|NCT02115542|Secondary|Disease Control Response (DCR)|DCR defined as Complete Response (CR) + Partial Response (PR)+ Stable Disease (SD). CR: Complete disappearance of all target and non-target lesions (with the exception of lymph nodes mentioned below); No new lesions. PR: Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions; No unequivocal progression of nonmeasurable disease; No new lesions. SD: Does not qualify for CR, PR, Progression or Symptomatic Deterioration.|Post 6 months follow-up, up to 13 months from on treatment per participant|Patients that were evaluable for efficacy|||percentage of patients|||Number
2604932|NCT02115542|Primary|Overall Survival (OS) at 6 Months|OS will be defined as the time from starting on trial to date of death due to any cause. The final analysis will be conducted after the follow-time of the last patient exceeds 6 months.|at 6 month follow-up|Patients that were evaluable for efficacy|||months||95% Confidence Interval|Median
2604938|NCT02115386|Secondary|Number of Participants With Improvement of Grades of Persistent Non-hematological Adverse Event (AE) for Grade 1 and 2 at 3 Months|Improvement was defined as decreasing of grade of non-hematological toxicity from 2 to <2 or from 1 to <1. In case of multiple low-grade non-hematological toxicities improvement was defined as an improvement of at least one non-hematological AE and no worsening of any other persistent non-hematological AEs.|at 3 month after switching from imatinib to nilotinib||||participants|||Number
2604939|NCT02115386|Primary|Number of Participants With Improvement of Grades of Persistent Non-hematological Adverse Event (AE) for Grade 1 and 2 at 6 Months|Improvement was defined as decreasing of grade of non-hematological toxicity from 2 to <2 or from 1 to <1. In case of multiple low-grade non-hematological toxicities improvement was defined as an improvement of at least one non-hematological AE and no worsening of any other persistent non-hematological AEs.|at 6 month after switching from imatinib to nilotinib||||participants|||Number
2604940|NCT02115373|Secondary|Phase 1b: Accumulation Ratio of AUC (Racc (AUC)|Accumulation ratio for AUC was calculated as AUC, after dosing on Day 15 divided by AUC, after dosing on day 1 of cycle 1.|Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours post-dose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|PK population included all participants who have received Tepotinib (MSC2156119J) and who had at least one blood sample drawn that provided drug concentration data for PK evaluation. Here, Overall number of participants analyzed signified participants who were evaluable for this outcome measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2604941|NCT02115373|Secondary|Phase 1b: Accumulation Ratio of Cmax (Racc (Cmax))|Accumulation ratio for Cmax was calculated as Cmax, after dosing on Day 15 divided by Cmax, after dosing on day 1 of cycle 1.|Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours post-dose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|PK population included all participants who have received Tepotinib (MSC2156119J) and who had at least one blood sample drawn that provided drug concentration data for PK evaluation. Here, Overall number of participants analyzed signified participants who were evaluable for this outcome measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2604942|NCT02115373|Secondary|Phase 1b: Percentage Peak-Trough Fluctuation (PTF) Post First Dose of Tepotinib|The peak trough fluctuation within complete dosing interval at steady state, calculated as PTF (%) = ([Cmax - Cmin]/Cav ) multiplied by 100|Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours post-dose; Day 15 of Cycle 1 (each Cycle is 21 days)|PK population included all participants who have received Tepotinib (MSC2156119J) and who had at least one blood sample drawn that provided drug concentration data for PK evaluation. Here, Overall number of participants analyzed signified participants who were evaluable for this outcome measure.|||percentage fluctuation||Geometric Coefficient of Variation|Geometric Mean
2604943|NCT02115373|Secondary|Phase 1b: Time Prior to the First Quantifiable (Non-zero) Concentration (Tlag) of Tepotinib||Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours post-dose; Day 1 Cycle 1 (each Cycle is 21 days)|PK population included all participants who have received Tepotinib (MSC2156119J) and who had at least one blood sample drawn that provided drug concentration data for PK evaluation.|||hours||Full Range|Median
2604944|NCT02115373|Secondary|Phase 1b: Apparent Terminal Half-life (t1/2) of Tepotinib||Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours post-dose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|PK population included all participants who have received Tepotinib (MSC2156119J) and who had at least one blood sample drawn that provided drug concentration data for PK evaluation.|||hours||Full Range|Median
2604945|NCT02115373|Secondary|Phase 1b: Apparent Terminal Elimination Rate Constant (λz) of Tepotinib||Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours post-dose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|PK population included all participants who have received Tepotinib (MSC2156119J) and who had at least one blood sample drawn that provided drug concentration data for PK evaluation.|||1 per hour||Geometric Coefficient of Variation|Geometric Mean
2604946|NCT02115373|Secondary|Phase 1b: Apparent Volume of Distribution During the Steady State (Vss/f) of Tepotinib||Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours post-dose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|PK population included all participants who have received Tepotinib (MSC2156119J) and who had at least one blood sample drawn that provided drug concentration data for PK evaluation.|||liter||Geometric Coefficient of Variation|Geometric Mean
2604947|NCT02115373|Secondary|Phase 1b: Apparent Volume of Distribution During the Terminal Phase (Vz/f) of Tepotinib||Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours post-dose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|PK population included all participants who have received Tepotinib (MSC2156119J) and who had at least one blood sample drawn that provided drug concentration data for PK evaluation.|||liter||Geometric Coefficient of Variation|Geometric Mean
2604948|NCT02115373|Secondary|Phase 1b: Apparent Total Body Clearance From Plasma (CL/f) of Tepotinib||Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours post-dose; Day 15 of Cycle 1 (each Cycle is 21 days)|PK population included all participants who have received Tepotinib (MSC2156119J) and who had at least one blood sample drawn that provided drug concentration data for PK evaluation. Here, Overall number of participants analyzed signified participants who were evaluable for this outcome measure.|||Liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2604949|NCT02115373|Secondary|Phase 1b: Average Plasma Concentration at Steady State (Cav) of Tepotinib||Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours post-dose; Day 15 of Cycle 1 (each Cycle is 21 days)|PK population included all participants who have received Tepotinib (MSC2156119J) and who had at least one blood sample drawn that provided drug concentration data for PK evaluation. Here, Overall number of participants analyzed signified participants who were evaluable for this outcome measure.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2604950|NCT02115373|Secondary|Phase 1b: Time to Reach Maximum Plasma Concentration (Tmax) of Tepotinib||Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours post-dose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|PK population included all participants who have received Tepotinib (MSC2156119J) and who had at least one blood sample drawn that provided drug concentration data for PK evaluation. Here, number analyzed signified participants evaluable at specified timepoint.|||hours||Full Range|Median
2605247|NCT02111746|Primary|Postoperative Pain as Assessed by a Five-point Satisfaction Scale|The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).|postoperative day 3|Intention-to-treat analysis. Data for this measure was collected for only 148 in the Exparel arm and 148 in the Regular Bupivacaine group.|||units on a scale||Standard Deviation|Mean
2604951|NCT02115373|Secondary|Phase 1b: Minimum Observed Plasma Concentration (Cmin) of Tepotinib||Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours post-dose; Day 15 of Cycle 1 (each Cycle is 21 days)|PK population included all participants who have received Tepotinib (MSC2156119J) and who had at least one blood sample drawn that provided drug concentration data for PK evaluation. Here, Overall number of participants analyzed signified participants who were evaluable for this outcome measure.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2604952|NCT02115373|Secondary|Phase 1b: Dose Normalized Maximum Observed Plasma Concentration (Cmax) of Tepotinib|Dose normalized was calculated as maximum observed plasma concentration obtained directly from the concentration versus time curve divided by dose.|Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours post-dose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|PK population included all participants who have received Tepotinib (MSC2156119J) and who had at least one blood sample drawn that provided drug concentration data for PK evaluation. Here, number analyzed signified participants evaluable at specified timepoint.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2604953|NCT02115373|Secondary|Phase 1b: Maximum Observed Plasma Concentration (Cmax) of Tepotinib|Cmax is the maximum observed plasma concentration obtained directly from the concentration versus time curve.|Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours post-dose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|PK population included all participants who have received Tepotinib (MSC2156119J) and who had at least one blood sample drawn that provided drug concentration data for PK evaluation. Here, number analyzed signified participants evaluable at specified timepoint.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2604954|NCT02115373|Secondary|Phase 1b: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tepotinib||Pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10 and 24 hours Post-dose on Day 1 and Day 15 of Treatment Cycle 1 (each cycle was 21 days)|Pharmacokinetic (PK) population included all participants who have received Tepotinib (MSC2156119J) and who had at least one blood sample drawn that provided drug concentration data for PK evaluation.|||nanogram hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2604955|NCT02115373|Secondary|Phase 1b: Dose Normalized Area Under the Plasma Concentration-Time Curve From Zero to Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Tepotinib|Dose normalized was calculated as area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration is at or above the lower limit of quantification (LLQ) divided by the dose.|Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours post-dose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|PK population included all participants who have received Tepotinib (MSC2156119J) and who had at least one blood sample drawn that provided drug concentration data for PK evaluation. Here, number analyzed signified participants evaluable at specified timepoint.|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2604956|NCT02115373|Secondary|Phase 1b: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Tepotinib||Pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10 and 24 hours Post-dose on Day 1 and Day 15 of Treatment Cycle 1 (each cycle was 21 days)|Pharmacokinetic (PK) population included all participants who have received Tepotinib (MSC2156119J) and who had at least one blood sample drawn that provided drug concentration data for PK evaluation. Here, number analyzed signified participants evaluable at specified timepoint.|||nanogram hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2604957|NCT02115373|Secondary|Phase 1b and Phase 2: Percentage of Participants With Biological Response|Percentage of participants with biological response was measured by serum Alpha-Fetoprotein (AFP), defined as a greater than 20% decrease in AFP level by Cycle 3 (each cycle is of 21 days) compared with baseline.|Baseline up to Cycle 3 (each cycle is 21 days)|ITT analysis set included all participants who had been administered at least one dose of Tepotinib (MSC2156119J). Here, “Overall number of participants analyzed” signified the participants with baseline and post baseline AFP assessments.|||percentage of participants||90% Confidence Interval|Number
2604958|NCT02115373|Secondary|Phase 1b and Phase 2: Percentage of Participants With Disease Control|Disease control was defined as CR, PR, or SD as the best overall response according to RECIST Version 1.1. Complete Response (CR) defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters, or Stable Disease (SD) defined as any cases that do not qualify for either partial response or progressive disease (an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started)12 weeks after start of treatment or later. Percentage of Participants With Disease Control were reported.|From date of randomization up to first occurrence of PD, assessed maximum up to 1369 days|ITT analysis set included all participants who had been administered at least one dose of Tepotinib (MSC2156119J).|||percentage of participants||90% Confidence Interval|Number
2604959|NCT02115373|Secondary|Phase 1b and Phase 2: Percentage of Participants With Best Overall Tumor Assessment of CR or PR According to RECIST v1.1|Percentage of participants with best overall tumor assessment of (CR or PR) according to RECIST Version 1.1 was reported. CR defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. PD was defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started.|From date of randomization up to first occurrence of PD, assessed maximum up to 1369 days|ITT analysis set included all participants who had been administered at least one dose of Tepotinib (MSC2156119J).|||percentage of Participants||90% Confidence Interval|Number
2605025|NCT02114697|Primary|Plaque Volume of Carotid Arteries|Plaque volume of carotid arteries were measured by MRI as a surrogate for progression of cardiovascular disease. Plaque volume varies with observed ranges from other studies ranging from 23.9 to 604.1mm^3. Plaque volume tends to increase with age. Increased plaque volume has an increased risk of vascular events.|Baseline, 18 months, 36 months|This analysis includes all participants who completed the MRI at each time point. Most participants did not return for the follow up MRI measurements.|||Cubic millimeter (mm^3)||Standard Deviation|Mean
2604960|NCT02115373|Secondary|Phase 1b and Phase 2: Overall Survival (OS) Time|The OS time was defined as the time from randomization to the date of death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. The descriptive data represents number of participants who had an event of death.|From date of randomization up to the date of death, assessed maximum up to 1369 days|ITT analysis set included all participants who had been administered at least one dose of Tepotinib (MSC2156119J).|||Participants|||Count of Participants
2604961|NCT02115373|Secondary|Phase 2: Time-to-symptomatic Progression (TTSP)|Time-to-symptomatic progression was defined as time (in months) from first study drug administration to the date of deterioration of symptoms assessed by Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index 8 (FHSI-8) (defined as at least a 4-point increase, i.e., higher score, compared with baseline value), or deterioration to Eastern Cooperative Oncology Group (ECOG) performance score 4, or death. FHSI-8 assesses hepatobiliary cancer symptoms with total score ranges from 0 to 32 (0 = the best quality of life; 32 = the worst quality of life with severe symptoms). ECOG assess participant's performance status on a scale of 0 to 5, where 0=fully active and 5=dead.|From date of randomization up to 1369 days|ITT analysis set included all participants who had been administered at least one dose of Tepotinib (MSC2156119J). Here, Overall number of participants analyzed signified those participants who had symptomatic progression. As per planned analysis, data for this outcome was analyzed for Phase 2 only.|||months||Full Range|Median
2604962|NCT02115373|Secondary|Phase 1b and Phase 2: Progression-free Survival (PFS) Time According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for Hepatocellular Carcinoma (HCC)|PFS time was defined as the time from date of randomization until date of the first observation of progressive disease (PD) or death due to any cause within 12 weeks of the last tumor assessment in the absence of documented PD, whichever occurs first. PFS was assessed as per mRECIST for HCC as adjudicated by independent endpoint review committee (IERC). PD was defined as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started. The descriptive data represents number of participants with death or progressive disease.|From randomization up to first observation of PD or death, assessed maximum up to 1369 days|ITT analysis set included all participants who had been administered at least one dose of Tepotinib (MSC2156119J).|||Participants|||Count of Participants
2604963|NCT02115373|Secondary|Phase 1b and Phase 2: Progression-free Survival (PFS) Time According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|PFS time was defined as the time from date of randomization until date of the first observation of progressive disease (PD) or death due to any cause within 12 weeks of the last tumor assessment in the absence of documented PD, whichever occurs first. PFS was assessed as per RECIST v1.1 as adjudicated by independent endpoint review committee (IERC). PD was defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started. The descriptive data represents number of participants with death or progressive disease.|From randomization up to first observation of PD or death, assessed maximum up to 1369 days|ITT analysis set included all participants who had been administered at least one dose of Tepotinib (MSC2156119J).|||Participants|||Count of Participants
2604964|NCT02115373|Secondary|Phase 1b and Phase 2: Time to Progression According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|TTP was the time (in months) from the date of first study drug administration to the date of radiological confirmation of PD performed according to RECIST Version 1.1. PD was defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started. The descriptive data represents the number of participants with progression.|Time from first study drug administration to the date of first occurrence of radiological progressive disease (PD), assessed up to 12 months after last participant's first dose (assessed maximum up to 1369 days)|ITT set included all participants who had been administered at least one dose of Tepotinib (MSC2156119J).|||Participants|||Count of Participants
2604965|NCT02115373|Primary|Phase 2: Number of Participants Who Were Progression-free at 12 Weeks (PFS Status) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|PFS status was evaluated by the number of participants who were progression-free at 12 weeks according to RECIST Version 1.1. Participants were considered to be progression-free if the participant had a tumor assessment of Complete Response (CR) defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeter (mm). Partial response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters, or Stable Disease (SD) defined as any cases that do not qualify for either partial response or progressive disease (an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started)12 weeks after start of treatment or later.|At 12 weeks post first-dose in Phase 2|Intent to Treat (ITT) set included all participants who had been administered at least one dose of Tepotinib (MSC2156119J). The outcome measure was planned to be analyzed for Phase 2 only.|||Participants|||Count of Participants
2604966|NCT02115373|Primary|Phase 1b: Number of Participants Experiencing Dose Limiting Toxicity (DLT) According to National Cancer Institute Common Toxicity Criteria (NCI-CTCAE) for Adverse Events (AEs) Version 4.0|DLT: defined using NCI-CTCAE for AEs Version 4.0, as any of following toxicities: Grade 4 neutropenia for more than 7 days; greater than or equal to (>=) Grade 3 febrile neutropenia for more than 1 day; Grade 4 or Grade 3 thrombocytopenia with nontraumatic bleeding; >=Grade 3 uncontrolled nausea/vomiting and/or diarrhoea despite adequate treatment for more than 3 days; >=Grade 3 any non-hematological AE. (DLT defined specifically for following cases: >=Grade 3 liver AE requiring recovery period of more than 7 days or to Grade 1 or less or Grade 2 with liver metastases ; >=Grade 3 lipase and/or amylase elevation with confirmation of pancreatitis. An isolated lipase and/or amylase elevation of >=Grade 3 without clinical/radiological evidence of pancreatitis was not classified as DLT); and AEs assessed by investigators to be exclusively related to the participant's underlying disease or medical condition/concomitant treatment are not considered as DLTs.|Day 1 to Day 21 of Cycle 1 (each cycle was 21 days)|DLT analysis set included all participants who completed Cycle 1 and who received 80 percent (%) or more of the planned cumulative dose of Tepotinib (MSC2156119J) in Cycle 1, and participants who experienced a DLT during Cycle 1.|||Participants|||Count of Participants
2604967|NCT02115347|Secondary|Number of Participants Who Experienced an Adverse Event|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 19 days|The analysis population was defined as all treated participants. Based on a statistical evaluation of the PK data from participants with moderate hepatic impairment and matched healthy volunteers, Part 2 of the study was not conducted and participants with mild hepatic impairment were not enrolled.|||Participants|||Number
2604968|NCT02115347|Secondary|Cmax for Fraction of Ertugliflozin Unbound in Plasma (Cmax,u)|Maximum plasma concentration for unbound drug (ertugliflozin only).|Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours|The analysis population was all treated participants who had at least 1 measurement of the Cmax,u parameter. Based on a statistical evaluation of the PK data from participants with moderate hepatic impairment and matched healthy volunteers, Part 2 of the study was not conducted and participants with mild hepatic impairment were not enrolled.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2604969|NCT02115347|Secondary|Maximum Plasma Concentration (Cmax) of Ertugliflozin|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.|Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours|The analysis population was all treated participants who had at least 1 measurement of the Cmax parameter. Based on a statistical evaluation of the PK data from participants with moderate hepatic impairment and matched healthy volunteers, Part 2 of the study was not conducted and participants with mild hepatic impairment were not enrolled.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2604970|NCT02115347|Secondary|AUCinf for Fraction of Ertugliflozin Unbound in Plasma (AUCinf,u)|Area under the plasma concentration-time profile from time zero extrapolated to infinite time for unbound drug (ertugliflozin only) (AUCinf, u).|Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours|The analysis population was all treated participants who had at least 1 measurement of the AUCinf,u parameter. Based on a statistical evaluation of the PK data from participants with moderate hepatic impairment and matched healthy volunteers, Part 2 of the study was not conducted and participants with mild hepatic impairment were not enrolled.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2604971|NCT02115347|Secondary|AUClast for Fraction of Ertugliflozin Unbound in Plasma (AUClast,u)|Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (Clast) for unbound drug (ertugliflozin only).|Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours|The analysis population was all treated participants who had at least 1 measurement of the AUClast,u parameter. Based on a statistical evaluation of the PK data from participants with moderate hepatic impairment and matched healthy volunteers, Part 2 of the study was not conducted and participants with mild hepatic impairment were not enrolled.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2604972|NCT02115347|Primary|AUC From Hour 0 to Infinity (AUCinf) for Ertugliflozin|Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf).|Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours|The analysis population was all treated participants who had at least 1 measurement of the AUCinf parameter. Based on a statistical evaluation of the PK data from participants with moderate hepatic impairment and matched healthy volunteers, Part 2 of the study was not conducted and participants with mild hepatic impairment were not enrolled.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2604973|NCT02115347|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUClast) for Ertugliflozin|Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration (AUClast).|Hour 0 (predose), and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours|The analysis population was all treated participants who had at least 1 measurement of the AUClast parameter. Based on a statistical evaluation of the PK data from participants with moderate hepatic impairment and matched healthy volunteers, Part 2 of the study was not conducted and participants with mild hepatic impairment were not enrolled.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2604974|NCT02115321|Secondary|Percentage of Participants Achieving Sustained Viral Response 24 Weeks After Completing Study Therapy (SVR24)|SVR24 was defined as HCV RNA levels <LLoQ 24 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Week 36|The FAS consists of all randomized participants who received at least one dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
2604975|NCT02115321|Secondary|Percentage of Participants Achieving Sustained Viral Response 4 Weeks After Completing Study Therapy (SVR4)|SVR4 was defined as HCV RNA levels <LLoQ 4 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Week 16|The FAS consists of all randomized participants who received at least one dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
2604976|NCT02115321|Secondary|Percentage of Participants With HCV RNA <LLoQ at Weeks 2, 4, and 12|HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Weeks 2, 4, and 12|Per protocol, this measure was to be determined in Arm 4 (Part C); however, enrollment was halted after Part A and thus no data are available.||||||
2604977|NCT02115321|Secondary|Percentage of Participants With HCV RNA Undetectable at Weeks 2, 4, and 12|HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Week 2, 4, and 12|Per protocol, this measure was to be determined in Arm 4 (Part C); however, enrollment was halted after Part A and thus no data are available.||||||
2605026|NCT02114684|Secondary|Proportion of Patients With Unfavourable Outcomes or Tuberculosis Recurrence in the Moxifloxacin and Control Arm.|A patient was defined as having an unfavourable outcome if he/she was not cured at the end of treatment or did not successfully complete treatment. Recurrence after completion of treatment was defined as two positive cultures within a period of four months without an intervening negative culture.|up to 2 years||||Participants|||Count of Participants
2604978|NCT02115321|Secondary|Mean Change From Baseline in Model for End-Stage Liver Disease (MELD) Scores in CP-B Participants|The MELD score provides an objective and granular assessment of liver improvement as a continuous variable. The calculation of MELD score is based on three biochemical variables (serum bilirubin, creatinine and international normalized ratio [INR] of prothrombin time). The MELD equation is as follows: 9.57 x ln(creatinine mg/dL) +3.78 x ln(bilirubin mg/dL) +11.2 x ln (INR) + 6.43. Scores are multiplied by 10 and rounded to the nearest whole number and range from 6 (less ill) to 40 (gravely ill). MELD scores were determined at Baseline (Day 1) and again at Week 12, Follow-up (FU) Week 12 (Week 24), and FU Week 24 (Week 36). Change from baseline in MELD score = Post-baseline MELD score - baseline MELD score.|Baseline and Weeks 12, 24, and 36|All CP-B participants in the FAS (all randomized participants who received at least one dose of study medication) with available data.|||Units on a scale||Standard Deviation|Mean
2604979|NCT02115321|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 12 weeks|The APaT population consisted of all randomized participants who received at least one dose of study medication.|||Number of participants|||Number
2604980|NCT02115321|Primary|Number of Participants Experiencing an Adverse Event (AE) During Treatment and First 14 Follow-up Days|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 weeks|The All Participants as Treated (APaT) population consisted of all randomized participants who received at least one dose of study medication.|||Number of participants|||Number
2604981|NCT02115321|Primary|Percentage of Participants Achieving Sustained Viral Response 12 Weeks After Completing Study Therapy (SVR12)|SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels below the lower limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.|Week 24|The Full Analysis Set (FAS) consists of all randomized participants who received at least one dose of study medication.|||Percentage of participants||95% Confidence Interval|Number
2604982|NCT02115308|Secondary|Late Gadolinium Enhancement and CIRCUMFERENTIAL Myocardial Strain|The Effects of the presence of LGE on CIRCUMFERENTIAL myocardial Strain|Day 1|LGE as determined by CMR imaging using the AHA 16 segment model.|||strain (unitless)|Myocardial Segments|Standard Deviation|Mean
2604983|NCT02115308|Secondary|Adverse Events|Adverse events were monitored and recorded on a specific Adverse Event (AE) log.|Day 1|Count of Adverse Events not clinically expect and reportable to IRB.|||Participants|||Count of Participants
2604984|NCT02115308|Secondary|Late Gadolinium Enhancement (LGE) and RADIAL Myocardial Strain|"For each subject, the 16-segments were visually assessed along the short-axis plane for the presence of LGE. These images were collected post regadenoson stress recovery using an inversion-recovery prepared, fast gradient echo sequence and a delay of at least 8 minutes after administration of a single dose of gadobenate dimeglumine.~The presence of LGE within a segment is a separate classification of segment type. The segment classifications in the other outcomes are determined from the prior positron-emission-tomography (PET) examination where the LGE determination is based solely on cardiac magnetic resonance (CMR) imaging collected data.~The measurement was performed to determine if the presence of LGE within a particular segment affect the resulting strain?"|Day 1|LGE imaging by CMR was acquired only in subjects meeting GFR restrictions.|||strain (unitless)|Myocardial Segments|Standard Deviation|Mean
2604985|NCT02115308|Primary|CIRCUMFERENTIAL STRAIN|"A measurement of the relative displacement of myocardial points directed along the circumference of the ventricular wall at a given radial distance from the left ventricular (LV) cavity center (e.g. midline). A normal circumferential strain is indicated by a negative decimal value and can be understood as the percentage shortening along the ventricular wall with a greater negative value indicating greater ventricular shortening along the circumference. A positive change in strain would therefore be interpreted as a decrease in circumferential shortening.~Because strain is a measurement in change in length (distance) divided by an original length (distance) it is considered unitless."|Day 1|Myocardial segments from the population groups according to the AHA 16-segment model and classified according to PET perfusion and wall motion scores.|||strain (unitless)|myocardial segments|Standard Deviation|Mean
2604986|NCT02115308|Primary|RADIAL STRAIN|"A measurement of the relative displacement between myocardial points between end-diastole and end-systole along a common ray extending from the center of the left ventricular (LV) cavity (analogous to myocardial thickening). A normal radial strain is indicated by a positive decimal value and can be understood as the percentage change in wall thickness of a myocardial segment. A POSITIVE change in radial strain indicates an increase in wall thickening.~Because strain is a measurement in change in length (distance) divided by an original length (distance) it is considered unitless."|Day 1|Myocardial segments classified according to subject groups and myocardial perfusion and wall motion scores on prior positron-emission-tomography (PET).|||unitless (strain)|myocardial segments|Standard Deviation|Mean
2604987|NCT02115269|Secondary|Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack|Defined as good and very good by Likert-type scale (e.g. very poor, poor, no opinion, good, very good)|baseline|Patients who took trip tans in the past (data are from Safety set which included all enrolled patients who have taken at least one dose of IndoProCaf).|||percentage of participants|||Number
2604988|NCT02115269|Secondary|Percentage of Patients With Significant Pain Reduction in Case of Headache Relapse|significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest|up to 48 hours|Patients who had headache relapse. Headache relapse was defined as a worsening of headache attack after 24 hours of the initial dosing and pain-free at 2h but no later than 48 hours of initial IndoProCaf dosing.|||percentage of participants|||Number
2604989|NCT02115269|Secondary|Percentage of Patients With Significant Pain Reduction in Case of First Dose no Response|significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest|up to 2 hours|Patients who took second IndoProCaf dose at 2 hours post-dose|||percentage of participants|||Number
2604990|NCT02115269|Secondary|Time to Significant Pain Reduction|Time to significant pain reduction at 1, 2, 4, 6 and 24 hours post-dose period are summarized with number of patients in each category; significant pain reduction is defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest|up to 24 hours post-dose|Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient’s diary. This population was used for the effectiveness endpoints reporting.|||participants|||Number
2604991|NCT02115269|Primary|Percentage of Patients Who Are Satisfied With IndoProCaf Treatment|Patients are asked to evaluate their satisfaction with headache pain reduction after treatment by selecting the options: =very poor, =poor, =no opinion, =good, =very good. The satisfied patients are defined as those with =good and = very good answers.|up to 24 hours post dose|Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient’s diary. This population was used for the effectiveness endpoints reporting.|||percentage of participants|||Number
2604992|NCT02115269|Primary|Percentage of Patients With Significant Pain Reduction|significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest|up to 2 hours|Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient’s diary. This population was used for the effectiveness endpoints reporting.|||percentage of participants|||Number
2604993|NCT02115256|Secondary|Tachycardia|Number of participants that had tachycardia|average of 1 hour||||Participants|||Count of Participants
2604994|NCT02115256|Secondary|Need for Cesarean Delivery|Number of participants that needed a cesarean delivery|average of 1 hour||||Participants|||Count of Participants
2604995|NCT02115256|Secondary|Hypotension|Number of participants with hypotension|average of 1 hour||||Participants|||Count of Participants
2604996|NCT02115256|Primary|Successful Version of the Fetus Into the Vertex Position|Number of participants that had successful version of the fetus into the vertex position.|average of 1 hour||||Participants|||Count of Participants
2604997|NCT02115113|Secondary|Change From Baseline (Randomization) in Serum Creatinine at 12 Months Post-transplant|Blood samples were collected to assess serum creatinine.|baseline, 12 months post-transplant|The safety population, which included all randomized participants who received at least one dose of study medication post-randomization, was considered for the analysis.|||mg/dL||Standard Error|Least Squares Mean
2604998|NCT02115113|Secondary|Percentage of Participants With Treated Biopsy Proven Acute Rejection (tBPAR) Acute Rejection (AR), Graft Loss (GL) or Death (D)|Participants were assessed for tBPAR, AR, GL or death. For all suspected rejection episodes, regardless of initiation of anti-rejection treatment, a liver biopsy was to be performed preferably within 24 hours, latest within 48 hours whenever clinically possible. A treated biopsy proven acute rejection was considered an episode of acute rejection when demonstrated by local pathology reading with a rejection activity index of at least 3 or greater of acute rejection index and when treated with anti-rejection therapy. The allograft was considered lost on the day the subject was re-transplanted or died due to liver failure.|At 12 and 18 months post-transplant|The safety population, which included all randomized participants who received at least one dose of study medication post-randomization, was considered for the analysis.|||Participants|||Count of Participants
2604999|NCT02115113|Primary|Renal Function Assessed by Estimated Glomerular Filtartion Rate (eGFR)|"Renal function was assessed by eGFR using the MDRD-4 formula at 12 months after transplant:~eGFR = 186.3 * (serum creatinine)-1.154 * age-0.203 * (0.742 for women) * (1.21 if African American) where serum creatinine was in mg/dL and age in years."|At 12 months post-transplant|The safety population, which included all randomized participants who received at least one dose of study medication post-randomization, was considered for the analysis. eGFR values missing at 12 months post transplantation were imputed using the Last Observation carried Forward (LOCF) approach.|||mL/min/1.73m^2||Standard Error|Least Squares Mean
2605000|NCT02115048|Secondary|Number of Participants With Adverse Events|"Participants who experienced at least one Treatment Emergent Adverse Event (TEAE) are presented. Participants with at least one serious TEAE, those who had at least one TEAE related to letrozole or afatinib (serious/non-serious), including participants who experienced a grade 3/4 TEAE, or who discontinued/died as a result of their TEAE are listed by treatment arm. Adverse events were tabulated by system organ class, preferred term and toxicity grade by treatment arm. For subjects in which treatment was discontinued for reasons different than progression of disease, the assessment was conducted every 12 weeks following treatment, and up to documentation of disease progression.~** Enrollment was closed prematurely due to low recruitment (only 44 participants enrolled) compared to what was initially planned (150 participants), therefore no statistical evaluations were completed. Adverse event data collected are described per arm but no statistical comparison was made."|Under treatment: every 4 wks up to 9 months (average) for subjects in Arm A or up to 14 months (average) for subjects in Arm B. After documentation of disease progression up to the end of the study: every 6 months up to 42 months|Participants who experienced at least one Treatment Emergent Adverse Event (TEAE) are listed. Participants with at least one serious TEAE, those who had at least one TEAE related to letrozole or afatinib (serious/non-serious), including participants who experienced a grade 3/4 TEAE, or who discontinued/died as a result of their TEAE are presented.|||Participants|||Count of Participants
2605027|NCT02114684|Secondary|Number of Participants With Adverse Events and 8-week Culture Conversion Rates Among HIV-infected Patients vs. HIV-uninfected Patients|To compare adverse events and 8-week culture conversion rates among HIV-infected patients vs. HIV-uninfected patients. The proportion of participants with at least one grade 3 or 4 adverse event was measured.|up to 2 years for adverse events and 8 weeks for culture conversion rates|9 participants had missing data at 8 weeks: 4 missed visits, 3 terminated before week 8, and 2 had MOTT cultured|||Participants|||Count of Participants
2605001|NCT02115048|Secondary|Time to Tumor Progression (TTP)|As per Response Evaluation Criteria In Solid Tumors (RECIST). Time to progression (TTP) is defined as the time interval from date of randomization to date of the first documented objective tumor progression.|Tumor assessments: every 12 weeks up to 9 months (average) for subjects in Arm A or up to 14 months (average) for subjects in Arm B.|The timeframe specifies when tumor assessments were performed. Enrollment was closed prematurely due to low recruitment (only 44 participants enrolled) compared to what was initially planned (150 participants), therefore data for TTP was not produced due to the small number of patients (evaluation would not produce meaningful data).||||||
2605002|NCT02115048|Secondary|Objective Response Rate (ORR)|"Objective response rate (ORR) is defined as the proportion of randomized subjects achieving a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST). As per RECIST (version 1.1):~CR is defined as disappearance of all target and non target lesions - lymph node (LN) <10mm.~PR is defined as at least a 30% decrease in the Sum of Diameters, taking as reference the Baseline Sum of Diameters"|Tumor assessment: every 12 weeks up to 9 months (average) for subjects in Arm A or up to 14 months (average) for subjects in Arm B.|The timeframe specifies when tumor assessments were performed. Enrollment was closed prematurely due to low recruitment (only 44 participants enrolled) compared to what was initially planned (150 participants), therefore no statistical evaluations were completed (including ORR).|||Participants|||Count of Participants
2605003|NCT02115048|Secondary|Overall Survival (OS)|"Overall Survival is defined as the time from randomization until death to any cause.~For subjects in which treatment is discontinued for reasons different than Progression Disease: after treatment and up to documentation of disease progression: Overall Survival is assessed every 12 weeks"|Under treatment: every 4 wks up to 9 months (average) for subject in the Arm A or up to 14 months (average) for subjects in Arm B. After documentation of disease progression up to the end of the study: every 6 months up to 42 months|The timeframe specifies when tumor assessments were performed. Enrollment was closed prematurely due to low recruitment (only 44 participants enrolled) compared to what was initially planned (150 participants), therefore no statistical evaluations were completed (including OS).|||Participants|||Count of Participants
2605004|NCT02115048|Primary|Progression Free Survival (PFS)|"Progression Free Survival (PFS) is defined as the time from randomization until date of progression (assessed by Response Evaluation Criteria in Solid Tumors - RECIST) or death due to any cause, whichever occurs first. For evaluation of PFS, the randomization date for each patient was the start date. If the status at the last assessment date was Non-complete response/ Non-progressive disease or Complete response, then the patient was considered censored. If the status at the last assessment for any tumor was Progressive disease, then the patient was considered as having an event.~Progressive disease is defined using RECIST v1 .1 as a ≥ 20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest diameter recorded or the appearance of one or more target or non-target new lesions and/or unequivocal progression of existing non-target lesions."|Tumor assessments were every 12 weeks up to 9 months (average) for subjects in Arm A or up to 14 months (average) for subjects in Arm B.|The timeframe specifies when tumor assessments were performed. Enrollment was closed prematurely due to low recruitment (only 44 participants enrolled) compared to what was initially planned (150 participants), therefore no statistical evaluations were completed (including PFS).|||Participants|||Count of Participants
2605005|NCT02114931|Secondary|Change From Parent Study Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)|"The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP) level~Patient's global assessment of disease activity assessed on a score from 0 to 100 transformed from the result measured on a horizontal scale from 0 (no RA activity at all) to 10 (worst RA activity imaginable).~The DAS28-CRP score ranges from approximately zero to ten. Higher DAS28-CRP scores indicate higher disease activity."|Parent study baseline, extension study baseline and weeks 4, 24, 48 and 70|Full analysis set with available data at each time point|||units on a scale||Standard Deviation|Mean
2605006|NCT02114931|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response|"A participant was a responder if the following 3 criteria for improvement from Baseline of the parent study were met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-Reactive Protein level."|Parent study baseline, extension study baseline and weeks 4, 24, 48, and 70|The full analysis set (all participants enrolled in the extension study) with available data at each time point|||percentage of participants|||Number
2605007|NCT02114931|Primary|Percentage of Participants Who Developed Antibodies to ABP 501|"Two validated assays were used to detect the presence of anti-drug antibodies. All samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies against ABP 501 (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.~Preexisting antibody positive indicates participants with a positive result at baseline of the extension study. Developing antibody positive indicates participants with a negative or no result at baseline of the extension study who were positive at any time point post-baseline during the extension study."|Up to week 72|The anti-drug antibody analysis set includes participants who received at least 1 dose of ABP 501 in the extension study and who had at least 1 evaluable antibody test assay against ABP 501 in the extension study.|||percentage of participants|||Number
2605008|NCT02114931|Primary|Number of Participants With Grade ≥ 3 Hematology and Chemistry Laboratory Results|"Laboratory results were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale:~1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal."|From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks|Safety analysis set|||participants|||Number
2605009|NCT02114931|Primary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale:~1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal. A treatment-related AE is defined as an event where the answer to the question is there a reasonable possibility that the event may have been caused by the Investigational Medicinal Product was yes.~A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria:~fatal~life threatening (places the subject at immediate risk of death)~requires inpatient hospitalization or prolongation of existing hospitalization~results in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event."|From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks|The safety analysis set included all participants enrolled and treated with at least 1 dose of ABP 501 in the extension study.|||participants|||Number
2605010|NCT02114892|Primary|Diastolic Blood Pressure at Week 12|The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||mmHg||Standard Deviation|Mean
2605011|NCT02114892|Primary|Waist Circumference at Week 12|Waist circumference was evaluated at baseline and at week 12 with a flexible tape and the entered values reflect the waist circumference measure at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||cm||Standard Deviation|Mean
2605012|NCT02114892|Secondary|Uric Acid at Week 12.|The uric acid levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the uric acid levels at week 12|Week 12.|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||µmol/l||Standard Deviation|Mean
2605013|NCT02114892|Secondary|Creatinine at Week 12.|The creatinine levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the creatinine levels at week 12|Baseline. Week 12.|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||µmol/l||Standard Deviation|Mean
2605014|NCT02114892|Secondary|Low Density Lipoproteins (c-LDL) at Week 12|The c-LDL levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||mg/dL||Standard Deviation|Mean
2605015|NCT02114892|Secondary|Total Cholesterol at Week 12|The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||mg/dL||Standard Deviation|Mean
2605016|NCT02114892|Secondary|Body Mass Index at Week 12|The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||kg/m2||Standard Deviation|Mean
2605017|NCT02114892|Secondary|Weight at Week 12.|The weight was measured at baseline, week 4, week 8 and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||kg||Standard Deviation|Mean
2605018|NCT02114892|Primary|Total Insulin Sensitivity at Week 12.|The insulin sensitivity was calculated at baseline and week 12 with Matsuda index and the entered values reflect the insulin sensitivity at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||unitless||Standard Deviation|Mean
2605019|NCT02114892|Primary|Total Insulin Secretion at Week 12.|The total insulin secretion was calculated at baseline and week 12 with insulinogenic index and the entered values reflect the total insulin secretion at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||unitless||Standard Deviation|Mean
2605020|NCT02114892|Primary|First Phase of Insulin Secretion at Week 12.|The first phase of insulin secretion was calculated at baseline and week 12 with Stumvoll index and the entered values reflect the first phase of insulin secretion at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||unitless||Standard Deviation|Mean
2605021|NCT02114892|Primary|Systolic Blood Pressure at Week 12.|The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||mmHg||Standard Deviation|Mean
2605022|NCT02114892|Primary|Fasting Glucose Levels at Week 12.|The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||mmol/L||Standard Deviation|Mean
2605023|NCT02114892|Primary|High Density Lipoprotein (c-HDL) Levels at Week 12.|The c-HDL levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||mg/dL||Standard Deviation|Mean
2605024|NCT02114892|Primary|Triglycerides Levels at Week 12|The triglycerides were evaluated at baseline and week 12 with enzymatic-colorimetric techniques and the entered values reflect the triglycerides level at week 12|Week 12|All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)|||mg/dL||Standard Deviation|Mean
2605423|NCT02109484|Primary|Number of Participants With Vaccine Induced Reactions|Maximum severity of all local reactions or systemic reactogenicity after any vaccination|7 days following each dose||||Participants|||Count of Participants
2605030|NCT02114684|Primary|Sputum Culture Conversion Rates at Week 8 and Month 6 Post Tuberculosis Treatment Initiation|The proportion of patients with negative sputum cultures at the end of the intensive phase (8 weeks) and the proportion of patients with negative sputum cultures at 6 months were compared between the two study arms. All participants with sputum culture results at week 8 and month 6 were included in the analysis.|24 weeks|Nine participants had missing data at week 8: 4 missed visits, 3 terminated before week 8 and 2 had MOTT cultured. Fourteen had missing data at month 6: 7 were terminated before month 6 and 7 missed their visits.|||Participants|||Count of Participants
2605031|NCT02114515|Secondary|Outpatient Healthcare Visit|EHR-reported|14 days post discharge|Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.|||Participants|||Count of Participants
2605032|NCT02114515|Secondary|Outpatient Healthcare Visit|Self-reported|14 days post discharge|Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.|||Participants|||Count of Participants
2605033|NCT02114515|Secondary|ED Visit, Re-hospitalization, or Death|Confirmed by EHR review|60 days post discharge|Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.|||Participants|||Count of Participants
2605034|NCT02114515|Secondary|ED Visit, Re-hospitalization, or Death|Confirmed by EHR review|30 days post discharge|Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.|||Participants|||Count of Participants
2605035|NCT02114515|Secondary|Re-hospitalization or Death|Confirmed by EHR review|60 days post discharge||||Participants|||Count of Participants
2605036|NCT02114515|Secondary|Re-hospitalization or Death|Confirmed by EHR review|30 days post discharge|Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.|||Participants|||Count of Participants
2605037|NCT02114515|Secondary|Death|Caregiver-reported and confirmed by EHR review|60 days post discharge|Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.|||Participants|||Count of Participants
2605038|NCT02114515|Secondary|Death|Caregiver-reported and confirmed by EHR review|30 days post discharge|Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.|||Participants|||Count of Participants
2605039|NCT02114515|Secondary|PROMIS Global Health, Mental (v1.1, SF)|"Change in T-score from baseline to 60 days post discharge (60 days minus baseline).~A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement."|60 days post discharge|Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.|||T-score||Standard Error|Mean
2605040|NCT02114515|Secondary|PROMIS Global Health, Physical (v1.1, SF)|"Change in T-score from baseline to 60 days post discharge (60 days minus baseline).~A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement."|60 days post discharge|Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.|||T-score||Standard Error|Mean
2605041|NCT02114515|Secondary|PROMIS Instrumental Support (v2.0, SF4a)|"Change in T-score from baseline to 60 days post discharge (60 days minus baseline).~A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement."|60 days post discharge|Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.|||T-score||Standard Error|Mean
2605042|NCT02114515|Secondary|PROMIS Emotional Support (v2.0, SF4a)|"Change in T-score from baseline to 60 days post discharge (60 days minus baseline).~A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement."|60 days post discharge|Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.|||T-score||Standard Error|Mean
2605043|NCT02114515|Secondary|PROMIS Informational Support (v2.0, SF4a)|"Change in T-score from baseline to 60 days post discharge (60 days minus baseline).~A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement."|60 days post discharge|Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.|||T-score||Standard Error|Mean
2605044|NCT02114515|Secondary|PROMIS Emotional Distress-Anxiety (v1.0, SF4a)|"Change in T-score from baseline to 60 days post discharge (60 days minus baseline).~A change in t-score <0 indicates improvement. A change equal to 0 indicates no change. A change >0 indicates worsening."|60 days post discharge|Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.|||T-score||Standard Error|Mean
2605045|NCT02114515|Secondary|PROMIS Global Health, Mental (v1.1, SF)|"Change in T-score from baseline to 30 days post discharge (30 days minus baseline).~A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement."|30 days post discharge|Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.|||T-score||Standard Error|Mean
2605046|NCT02114515|Secondary|PROMIS Global Health, Physical (v1.1, SF)|"Change in T-score from baseline to 30 days post discharge (30 days minus baseline).~A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement."|30 days post discharge|Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.|||T-score||Standard Error|Mean
2605047|NCT02114515|Secondary|PROMIS Instrumental Support (v2.0, SF4a)|"Change in T-score from baseline to 30 days post discharge (30 days minus baseline).~A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement."|30 days post discharge|Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.|||T-score||Standard Error|Mean
2605048|NCT02114515|Secondary|PROMIS Emotional Support (v2.0, SF4a)|"Change in T-score from baseline to 30 days post discharge (30 days minus baseline).~A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement."|30 days post discharge|Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.|||T-score||Standard Error|Mean
2605049|NCT02114515|Primary|PROMIS Informational Support (v2.0, SF4a)|"Change in T-score from baseline to 30 days post discharge (30 days minus baseline).~A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement."|30 days post discharge|Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.|||T-score||Standard Error|Mean
2605050|NCT02114515|Primary|PROMIS Emotional Distress-Anxiety (v1.0, SF4a)|"Change in T-score from baseline to 30 days post discharge (30 days minus baseline).~A change in t-score <0 indicates improvement. A change equal to 0 indicates no change. A change >0 indicates worsening."|30 days post discharge|Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.|||T-score||Standard Error|Mean
2605051|NCT02114385|Secondary|Percentage of Participants With One or More Serious Adverse Events|The percentage of participants with one or more serious adverse events was assessed.|Up to 15 days after any vaccination|All participants who received at least one study vaccination and had safety follow-up data|||Percentage of participants|||Number
2605052|NCT02114385|Secondary|Percentage of Participants With One or More Systemic Adverse Events|The percentage of participants with one or more systemic adverse events was assessed.|Up to 15 days after any vaccination|All participants who received at least one study vaccination and had safety follow-up data|||Percentage of participants|||Number
2605053|NCT02114385|Secondary|Percentage of Participants With Maximum Temperature ≥37.8 °C|The percentage of participants with a maximum temperature ≥37.8 °C was assessed.|Up to 5 days after any vaccination|All participants who received at least one study vaccination and had safety follow-up data|||Percentage of participants|||Number
2605054|NCT02114385|Secondary|Percentage of Participants With One or More Injection-site Adverse Reactions|The percentage of participants with one or more injection-site adverse reactions (solicited or unsolicited) was assessed.|Up to 5 days after any vaccination|All participants who received at least one study vaccination and had safety follow-up data|||Percentage of participants|||Number
2605055|NCT02114385|Secondary|Percentage of Participants With Study Discontinuation Due to an Adverse Event|The percentage of participants discontinued from the study due to an adverse event was assessed.|Up to Month 7|All participants who received at least one study vaccination and had safety follow-up data|||Percentage of participants|||Number
2605056|NCT02114385|Secondary|Percentage of Participants With One or More Adverse Events|The percentage of participants with one or more adverse events was assessed.|Up to 15 days after any vaccination|All participants who received at least one study vaccination and had safety follow-up data|||Percentage of participants|||Number
2605057|NCT02114385|Secondary|Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58|Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Type 33: ≥8; HPV Type 45: ≥8; HPV Type 52: ≥8; HPV Type 58: ≥8.|4 weeks postdose 3 (Month 7)|All randomized participants. The number contributing to each data point is participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology for the HPV type within acceptable day ranges, were seronegative at Day 1, and had no protocol violations that interfered with evaluation of immune response.|||Percentage of participants||95% Confidence Interval|Number
2605058|NCT02114385|Secondary|GMTs to HPV Types 31/33/45/52/58|Serum antibodies to HPV types 31, 33, 45, 52, and 58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL.|4 weeks postdose 3 (Month 7)|All randomized participants. The number contributing to each data point is participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology for the HPV type within acceptable day ranges, were seronegative at Day 1, and had no protocol violations that interfered with evaluation of immune response|||milli Merck U/mL||95% Confidence Interval|Geometric Mean
2605059|NCT02114385|Primary|Geometric Mean Titers (GMTs) to HPV Types 6/11/16/18|Serum antibodies to HPV types 6, 11, 16, and 18 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL.|4 weeks postdose 3 (Month 7)|All randomized participants. The number contributing to each data point is participants who received all 3 vaccinations within acceptable day ranges, had Month 7 serology for the HPV type within acceptable day ranges, were seronegative at Day 1, and had no protocol violations that interfered with evaluation of immune response.|||milli Merck U/mL||95% Confidence Interval|Geometric Mean
2605060|NCT02114307|Secondary|Clinical Symptoms|Change in clinical symptoms as assessed by the Venous Clinical Severity Score (VCSS) from 0 to 6 weeks, lower score means improvement. Maximum score on VCSS is 30. Minimum score is 0.|0 and 6 weeks||||Percentage change in VCSS score||Standard Deviation|Mean
2605061|NCT02114307|Secondary|Changes in Limb Swelling, Volume|"Lower limb oedema measured before and after using the device at 0 and 6 weeks using a perimeter.~Limb volume was measured using an optoelectronic limb volumeter. Patients using compression stockings were advised to remove stockings 2 h prior to their appointment. Measurements were taken with the patient seated and the affected leg in a horizontal position. Five readings were taken before and after device usage at Week 0 and Week 6"|0 and 6 weeks||||ml||Standard Deviation|Mean
2605062|NCT02114307|Primary|Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV|Femoral vein haemodynamics is measured using ultrasound scan - Time Averaged Mean Velocity|0 and 6 weeks||||percentage change||Standard Deviation|Mean
2605063|NCT02114268|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA)|Participants were tested for anti-drug antibody to MEDI8897 prior to enrollment, predose and postdose.|Predose and Day 15, 31, 91, 181, 271 and 361|The As-treated Population included participants who receive any study investigational product.|||participants|||Number
2605064|NCT02114268|Secondary|Volume of Distribution (Vz) for MEDI8897|The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a study drug. Apparent volume of distribution (Vz/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.|||milliliter (ml)||Standard Deviation|Mean
2605065|NCT02114268|Secondary|Systemic Clearance (CL) for MEDI8897|Systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after the dose was estimated by dividing the total administered dose by the Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]). Apparent clearance (CL/F) for the IM dose groups. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.|||ml per day||Standard Deviation|Mean
2605066|NCT02114268|Secondary|Terminal Phase Elimination Half Life (t1/2) for MEDI8897|The terminal elimination half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). Here 'n' signifies participants evaluable for specified categories, for each arm, respectively. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.|||Day||Standard Deviation|Mean
2605067|NCT02114268|Secondary|Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) for MEDI8897|The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.|||Day*microgram per milliliter||Standard Deviation|Mean
2605068|NCT02114268|Secondary|Maximum Observed Serum Concentration (Cmax) for MEDI8897|The Cmax is the maximum observed serum concentration of MEDI8897. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.|||microgram per milliliter (mcg/ml)||Standard Deviation|Mean
2605069|NCT02114268|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI8897|The Tmax is defined as actual sampling time to reach maximum observed MEDI8897 concentration. The reported Standard Deviation values are actually Relative Standard Deviation (RSD) values (that is, Coefficient of Variation).|Predose, End of Dosing (IV Arms), 8 Hour Postdose, Day 2, 4, 6, 8, 15, 22, 31, 61, 91, 121, 151, 181, 271 and 361|Pharmacokinetic parameter analysis population included all randomized population treated with MEDI8897. Number of participants analyzed signifies those participants who were evaluable for the measure.|||Day||Standard Deviation|Mean
2605070|NCT02114268|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) is defined as events present at baseline that worsened in intensity after administration of investigational products or events absent at baseline that emerged after administration of study drug, for the period extending to 391 (Day 361 ± 30 days) days after the last dose of study drug.|From start of study drug administration up to Day 391 (Day 361 +/- 30 days)|The As-treated population included participants who receive any study investigational product.|||participants|||Number
2605071|NCT02114216|Secondary|PAR2 and IL-8 Expression of Esophageal Mucosa|The primers used in real-time qPCR were designed using PrimerExpress Software V2.0 (Applied Biosystems, Foster City, CA, USA) based on sequence information from the National Center for Biotechnology Information database. Real-time qPCR was performed in triplicate by using a StepOnePlus Real-time PCR (Applied Biosystems) with SYBR Premix Ex TaqTM (Takara Bio, Shiga, Japan) according to manufacturers' instructions and protocols. Thermal cycling was performed as follows: initial denaturation at 95 °C for 10s followed by 40 cycles of 95 °C for 5 s and 60 °C for 33s. Homo b-actin was used as a reference; i.e. each sample was normalized on the basis of its b-actin content. The relative change in all target genes expression was determined by the fold-change analysis.|up to 24weeks||||Fold change||Standard Error|Mean
2605072|NCT02114216|Primary|TRPV1, GDNF, and NGF mRNA Expression of Esophageal Mucosa|The primers used in real-time qPCR were designed using PrimerExpress Software V2.0 (Applied Biosystems, Foster City, CA, USA) based on sequence information from the National Center for Biotechnology Information database. Real-time qPCR was performed in triplicate by using a StepOnePlus Real-time PCR (Applied Biosystems) with SYBR Premix Ex TaqTM (Takara Bio, Shiga, Japan) according to manufacturers' instructions and protocols. Thermal cycling was performed as follows: initial denaturation at 95 °C for 10s followed by 40 cycles of 95 °C for 5 s and 60 °C for 33s. Homo b-actin was used as a reference; i.e. each sample was normalized on the basis of its b-actin content. The relative change in all target genes expression was determined by the fold-change analysis.|up to 24weeks||||Fold change||Standard Error|Mean
2605073|NCT02114203|Secondary|Time for Maximum Observed Plasma Concentration (Tmax) of PF-04447943||Prior to 0 hour, and 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 1|The full analysis set (FAS) was used for all PK analyses, and it included all participants randomized to treatment who had taken at least 1 dose of study medication. Data for this outcome measure were not planned to be analyzed for the placebo arm.|||hours||Full Range|Median
2605074|NCT02114203|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-04447943||Prior to 0 hour, and 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 1|The full analysis set (FAS) was used for all PK analyses, and it included all participants randomized to treatment who had taken at least 1 dose of study medication. Data for this outcome measure were not planned to be analyzed for the placebo arm.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2605075|NCT02114203|Secondary|Area Under the Curve From Time Zero to 12 Hours Post Dose (AUC(0-12h)) of PF-04447943|AUC(0-12h) referred to area under the plasma concentration-time curve from 0 to 12 hours post dose.|Prior to 0 hour, and 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 1|The full analysis set (FAS) was used for all PK analyses, and it included all participants randomized to treatment who had taken at least 1 dose of study medication. Data for this outcome measure were not planned to be analyzed for the placebo arm.|||nanogram*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
2605076|NCT02114203|Primary|Number of Participants With Laboratory Test Abnormalities|The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute total neutrophils, eosinophils, monocytes, basophils, and lymphocytes), chemistry (blood urea nitrogen/urea, serum creatinine, fasting glucose, calcium, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, and high sensitivity C-reactive protein), urinalysis (pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, and microscopy), and other tests (follicle stimulating hormone and serum human chorionic gonadotropin, urine drug screening). Abnormality was determined by the investigator.|Baseline up to 30 days post last dose on Day 29|The safety analysis population was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
2605077|NCT02114203|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to follow-up visit (30 days post last dose on Day 29) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs.|Day 1 to 30 days post last dose on Day 29|The safety analysis population was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
2605078|NCT02114203|Primary|Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Symptoms of Sickle Cell Disease|The following symptoms were assessed: anemia; fatigue; chronic pain; acute pain; infections; fever; swelling hands; swelling feet; abdominal swelling; pale skin; pale nail beds; yellow tint to skin; whites of eyes turned yellow; stroke. Number of participants with changes from baseline deemed potentially clinically important by the investigator is presented.|Baseline up to 30 days post last dose on Day 29|The safety analysis population was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
2605079|NCT02114203|Primary|Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings|Maximum absolute values and increases from baseline were summarized for PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization), QRS complex (time from Q wave to the end of S wave, corresponding to ventricle depolarization), and QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula). Number of participants with ECG findings meeting the following criteria is presented: (1) PR interval >=300 msec; (2) QRS complex >=200 msec; (3) QTcF interval: 450 to <480 msec; (4) QTcF interval: 480 to <500 msec; (5) QTcF interval >=500 msec; (6) PR interval percent increase from baseline >=25/50 percent; (7) QRS complex percent increase from baseline >=25/50 percent; (8) QTcF interval increase from baseline: 30 to <60 msec; (9) QTcF interval increase from baseline >=60 msec.|Baseline up to 30 days post last dose on Day 29|The safety analysis population was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
2605080|NCT02114203|Primary|Number of Participants With Potentially Clinically Important (PCI) Change in Physical Examination Findings|Physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Clinical importance of physical examination changes was determined by the investigator.|Baseline up to 30 days post last dose on Day 29|The safety analysis population was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
2605081|NCT02114203|Primary|Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Neurologic Function|Clinical assessment of neurologic functions included cranial nerve function, coordination, deep tendon reflexes, muscle strength, and reflexes (left and right ankles). Clinical importance of neurologic function changes was determined by the investigator.|Baseline up to Day 29|The safety analysis population was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
2605082|NCT02114203|Primary|Number of Participants With Potentially Clinically Important (PCI) Change From Baseline in Vital Signs|Number of participants with changes from baseline in vital signs meeting the following criteria is presented: (1) maximum increase from baseline in supine systolic blood pressure (SBP) >=30 millimeters of mercury (mmHg); (2) maximum increase from baseline in supine diastolic blood pressure (DBP) >=20 mmHg; (3) maximum decrease from baseline in supine SBP >=30 mmHg; and (4) maximum decrease from baseline in supine DBP >=20 mmHg.|Baseline up to 30 days post last dose on Day 29|The safety analysis population was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
2605092|NCT02114177|Primary|Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)|Participants considered to have achieved SVR12, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the actual end of study drug treatment.|12 weeks after the end of treatment (EOT) (Week 20 or Week 24)|Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2605424|NCT02109458|Secondary|Positive Diagnostic Yield of Bronchoscopic Biopsy of ETTNA + EBUS + NB|Positive diagnostic yield of bronchoscopic biopsy of ETTNA + EBUS + NB was defined by participants having benign or malignant pathology.|Approximately 1 week upon receipt of pathology report||||participants|||Number
2605083|NCT02114177|Secondary|Change From Baseline in EuroQol 5 Dimension (EQ-5D) Visual Analogue Scale|"The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a thermometer visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening."|Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||units on a scale||Standard Error|Mean
2605084|NCT02114177|Secondary|Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) Scores|The CES-D scale assesses how often during the past week participants experienced 20 symptoms commonly associated with major depression. CES-D scores range from 0 (no symptoms) to 60 (all 20 symptoms most or all of the time during the past 5-7 days). The CES-D scores between 16 and 23 points indicate mild to moderate depressive illness while CES-D scores greater than or equal to 23 indicate probable major depressive illness.|Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||units on a scale||Standard Error|Mean
2605085|NCT02114177|Secondary|Change From Baseline in Fatigue Severity Scale (FSS) Score up to Follow-up Week 24|The FSS was a self-administered questionnaire with 9 items developed to assess disabling fatigue that has been used extensively in studies of chronic HCV infection. Item responses were measured on a 7point Likert scale ranging from strongly disagree (1 point) to strongly agree (7 points). The 9 items were averaged to produce a total score; a lower total score indicates less severe fatigue. FSS scores have a range from 1 to 7 where higher scores indicate more severe fatigue.|Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||units on a scale||Standard Error|Mean
2605086|NCT02114177|Secondary|Change From Baseline in Hepatitis C Symptom and Impact Questionnaire 4 (HCV-SIQv4) Overall Body System Score (OBSS)|HCVSIQv4 OBSS was a self-administered questionnaire that contained 33 items: 29 questions developed to assess severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. A symptom severity score (the mean of responses to the 29 symptom items); each symptom score was transformed to have a range from 0 to 100 (most severe). Higher HCV SIQv4 scores indicates worse symptom severity, more time missed from work/school, and more impairment in daily activities, respectively.|Baseline (Day 1), Week 4, Week 8, Week 12, Follow-up Week 4, Follow-up Week 12 and Follow-up Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||units on a scale||Standard Error|Mean
2605087|NCT02114177|Secondary|Percentage of Participants With Viral Relapse|Percentage of participants who did not achieve sustained virologic response 12, have less than 25 IU/mL undetectable plasma HCV RNA at end of treatment, and greater than or equal to 25 IU/mL plasma HCV RNA during the follow-up phase.|Up to Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Percentage of participants|||Number
2605088|NCT02114177|Secondary|Percentage of Participants With Viral Breakthrough|Percentage of participants with greater than 1 log10 IU/mL increase in plasma Hepatitis C virus ribonucleic acid level from the lowest level reached (ie, lowest value measured in between baseline and current value), or a confirmed plasma HCV RNA level of greater than 100 IU/mL in participants whose plasma HCV RNA had previously been less than 25 IU/mL.|Up to Week 24|The ITT population included all the randomized participants who took at least 1 dose of study drug.|||Percentage of participants|||Number
2605089|NCT02114177|Secondary|Percentage of Participants Achieving a On-treatment Virologic Response|Ontreatment virologic response was determined by HCV RNA results satisfying a specified threshold. <LLOQ undetectable was considered as threshold at any time point. The LLOQ value is 25 IU/mL. EOT=End of Treatment.|Day 14, Day 28, End of treatment (Week 8 or Week 12)|The ITT population included all the randomized participants who took at least 1 dose of study drug. Here, ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Percentage of participants|||Number
2605090|NCT02114177|Secondary|Percentage of Participants Achieving a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)|Participants considered to have achieved SVR24, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 24 weeks after the Actual end of study drug treatment.|24 weeks after the end of treatment (EOT) (Week 32 or Week 36)|Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2605091|NCT02114177|Secondary|Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)|Participants considered to have achieved SVR4, if the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) detectable or undetectable at 4 weeks after the actual end of study drug treatment.|4 weeks after the end of treatment (EOT) (Week 12 or Week 16)|Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
2605093|NCT02114151|Secondary|Number of Participants Not Achieving SVR Showing Emerging Mutation at Time of Failure in HCV NS3/4A Sequence and NS5B up to Follow-up Week 24|Sequencing of the HCV nonstructural protein 3/4A (NS3/4A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. Sequencing data is available for 16 participants.|Baseline, Day 3, Week 1, 2, 3, 4, 8, 12, Follow-up Week 4, 12 and 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Participants|||Number
2605094|NCT02114151|Secondary|Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D) up to Follow-up Week 24|"The EQ-5D questionnaire was a brief, generic health-related quality of life (HRQOL) assessment that could also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assessed HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a thermometer visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health)."|Baseline, Follow-up Week 12 and 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a Scale||Standard Error|Mean
2605095|NCT02114151|Secondary|Percentage of Participants With Depression by Using Center for Epidemiologic Studies Depression Scale (CES-D)|The CES-D Scale assessed how often during the past week participants experienced 20 symptoms commonly associated with major depression. The CES-D scores range from 0 (no symptoms) to 60 (all 20 symptoms most or all of the time during the past 5 to 7 days). The CES-D scores between 16 and 23 points indicate mild to moderate depressive illness while CES-D scores >=23 indicate probable major depressive illness.|Baseline, Week 12, Follow-up Week 12 and 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Percentage of Participants|||Number
2605096|NCT02114151|Secondary|Change From Baseline in Fatigue Severity Score (FSS) up to Follow-up Week 24|The FSS was a self-administered questionnaire with 9 items developed to assess disabling fatigue that has been used extensively in studies of chronic HCV infection. Item responses were measured on a 7-point Likert scale ranging from strongly disagree (1 point) to strongly agree (7 points). The 9 items were averaged to produce a total score; a lower total score indicates less severe fatigue. FSS scores have a range from 1 to 7 where higher scores indicate more severe fatigue.|Baseline, Week 12, Follow-up Week 12 and 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a Scale||Standard Error|Mean
2605097|NCT02114151|Secondary|Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Overall Body System Score (OBSS) up to Follow-up Week 12|The HCV-SIQv4 OBSS was a self-administered questionnaire that contained 33 items: 29 questions developed to assess severity or frequency of symptoms associated with HCV or its treatment, 3 questions regarding the impact of symptoms on work/school attendance, and 1 question regarding the impact of symptoms on daily activities. A symptom severity score (the mean of responses to the 29 symptom items); each symptom score was transformed to have a range from 0 to 100 (most severe). Higher HCV SIQv4 scores indicates worse symptom severity, more time missed from work/school, and more impairment in daily activities, respectively.|Baseline, Week 4, Week 12 and Follow-Up Week 12|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure and ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Units on a Scale||Standard Error|Mean
2605098|NCT02114151|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as participants who did not achieve SVR12 and had HCV RNA < LLOQ (25 IU/mL) undetectable at EOT and had HCV RNA >= LLOQ (25 IU/mL) during the follow-up period.|During the Follow-up (Week 24)|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2605099|NCT02114151|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as confirmed greater than (>) 1 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA < LLOQ (25 IU/mL).|Up to End of Treatment (Week 12)|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.|||Percentage of Participants|||Number
2605100|NCT02114151|Secondary|Percentage of Participants With On-treatment Failure|On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment.|Week 12|Intent-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.|||Percentage of Participants|||Number
2605101|NCT02114151|Secondary|Percentage of Participants With On-treatment Virologic Response|On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. <LLOQ undetectable was considered as threshold at any time point. The LLOQ value is 25 IU/mL. EOT=End of Treatment.|Week 2, 4 and End of Treatment (Week 12)|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Percentage of Participants|||Number
2605116|NCT02113956|Secondary|Number of Unprotected Sex Acts Among Sexually Experienced at 3-months Post-intervention|The relative difference of unprotected anal and/or vaginal sex acts in the intervention versus control group at 3-months post-intervention among youth who have ever had sex at baseline|3-months post-intervention|Youth who had ever had sex at baseline|||unprotected sex acts||Standard Deviation|Mean
2605102|NCT02114151|Secondary|Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 24 weeks after the actual end of treatment.|Week 36|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.|||Percentage of Participants||95% Confidence Interval|Number
2605103|NCT02114151|Secondary|Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the actual end of treatment.|Week 16|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.|||Percentage of Participants||95% Confidence Interval|Number
2605104|NCT02114151|Primary|Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the actual end of treatment.|Week 24|Intent-to-treat (ITT) population included all enrolled participants who took at least 1 dose of investigational medication.|||Percentage of Participants||95% Confidence Interval|Number
2605105|NCT02113956|Secondary|Percent of Sexually Experienced Boys Reporting Being Tested for HIV Since Program Start at 5 Weeks Post-enrollment|The relative difference of HIV testing since the beginning of the program in the intervention versus control group at intervention end (5 weeks post enrollment) among those who ever had vaginal or anal sex with a penis at baseline|Intervention end (5 weeks post enrollment)|Among the 144 youth who had ever had sex at baseline and completed the 5 week intervention end survey.|||Participants|||Count of Participants
2605106|NCT02113956|Secondary|Percent of Boys Reporting Abstinence Among Sexually Inexperienced at 5 Weeks Post-enrollment|At 5 weeks post-enrollment, participants were asked whether or not they had had vaginal and anal sex since the beginning of the program. Those who said no to both were coded as abstinent. The relative difference of abstinence (neither engaging in anal nor vaginal sex) was examined among youth who have never had sex at baseline in the intervention versus control groups.|Intervention end (5 weeks post enrollment)|Among the 145 youth who had never had sex at baseline and completed the 5 week intervention end survey.|||Participants|||Count of Participants
2605107|NCT02113956|Secondary|Percent of Boys Reporting Abstinence Among Sexually Experienced at 5 Weeks Post-enrollment|At 5 weeks post-enrollment, participants were asked whether or not they had had vaginal and anal sex since the beginning of the program. Those who said no to both were coded as abstinent. The relative difference of abstinence (neither engaging in anal nor vaginal sex) was examined among youth who have ever had sex at baseline in the intervention versus control groups.|Intervention end (5-weeks post enrollment)|Among the 144 youth who had ever had sex at baseline and completed the 5 week intervention end survey.|||Participants|||Count of Participants
2605108|NCT02113956|Secondary|Number of Unprotected Sex Acts Among Sexually Inexperienced Boys at 5 Weeks Post-enrollment|The relative difference of unprotected anal and/or vaginal sex acts in the intervention versus control group at at intervention end (5 weeks post enrollment) among youth who have never had sex at baseline|Intervention end (5-weeks post enrollment)|Among the 145 youth who had never had sex at baseline and completed the 5 week intervention end survey.|||unprotected sex acts||Standard Deviation|Mean
2605109|NCT02113956|Secondary|Number of Unprotected Sex Acts Among Sexually Experienced Boys at 5 Weeks Post-enrollment|The relative difference of unprotected anal and/or vaginal sex acts in the intervention versus control group intervention end (5 weeks post enrollment) among youth who have ever had sex at baseline|Intervention end (5-weeks post enrollment)|Among the 144 youth who had ever had sex at baseline and completed the 5 week intervention end survey.|||unprotected sex acts||Standard Deviation|Mean
2605110|NCT02113956|Secondary|Percent of Boys Reporting Abstinence at 5 Weeks Post-enrollment|The relative difference of abstinence (neither engaging in anal nor vaginal sex) in the intervention versus control group at intervention end (5 weeks post enrollment).|Intervention-end (5 weeks post-randomization)||||Participants|||Count of Participants
2605111|NCT02113956|Secondary|Number of Condomless Sex Acts at 5 Weeks Post-enrollment|Relative difference of unprotected sex acts at intervention end (5 weeks post enrollment) for those in the intervention versus control groups|Intervention end (5-weeks post enrollment)||||unprotected sex acts||Standard Deviation|Mean
2605112|NCT02113956|Secondary|Percent of Sexually Active Boys Reporting an HIV Test in the Past 3 Months at 3-months Post-intervention|The relative difference of HIV testing over the past 3 months in the intervention versus control group at 3-months post-intervention among those who had ever vaginal or anal sex with a penis at baseline|3-months post-intervention|Youth who have ever had vaginal or anal sex with a penis at baseline|||Participants|||Count of Participants
2605113|NCT02113956|Secondary|Percent of Boys Reporting Abstinence Among Sexually Inexperienced at 3-months Post-intervention|At 3 months post intervention participants were asked whether or not they had had vaginal and anal sex in the past 90 days. Those who said no to both were coded as abstinent. The relative difference of abstinence (neither engaging in anal nor vaginal sex) was examined among youth who have never had sex at baseline in the intervention versus control groups.|3-months post-intervention|Youth who had never had sex at baseline|||Participants|||Count of Participants
2605114|NCT02113956|Secondary|Percent of Boys Reporting Abstinence Among Sexually Experienced at 3-months Post-intervention|At 3 months post intervention participants were asked whether or not they had had vaginal and anal sex in the past 90 days. Those who said no to both were coded as abstinent. The relative difference of abstinence (neither engaging in anal nor vaginal sex) was examined among youth who have ever had sex at baseline in the intervention versus control groups.|3-months post-intervention|Youth who had ever had sex at baseline|||Participants|||Count of Participants
2605115|NCT02113956|Secondary|Number of Unprotected Sex Acts Among Sexually Inexperienced at 3-months Post-intervention|The relative difference of unprotected anal and/or vaginal sex acts in the intervention versus control group at 3-months post-intervention among youth who have never had sex at baseline|3-months post-intervention|Youth who had never had sex at baseline|||unprotected sex acts||Standard Deviation|Mean
2605676|NCT02107339|Secondary|Pain Scores 1 Hour After PACU Arrival|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores at 60 minutes after PACU admission||||units on a scale||Inter-Quartile Range|Median
2605117|NCT02113956|Primary|Percent of Boys Reporting Abstinence at 3-months Post-intervention|At 3 months post intervention participants were asked whether or not they had had vaginal and anal sex in the past 90 days. Those who said no to both were coded as abstinent. The relative difference of abstinence (neither engaging in anal nor vaginal sex) was examined in the intervention versus control group.|3-months post-intervention||||Participants|||Count of Participants
2605118|NCT02113956|Primary|The Number of Condomless Sex Acts at 3-months Post-intervention|The relative difference of unprotected anal and/or vaginal sex acts in the intervention versus control group at 3-months post-intervention. The count was truncated at 10 or higher to correct for over-dispersion.|3-months post-intervention||||number of unprotected sex acts||Standard Deviation|Mean
2605119|NCT02113579|Secondary|Global Subjective VAS Score at Week 4|"At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows:Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that elicit your dentinal hypersensitivity pain/discomfort since you have been using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|4 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.|||units on a scale (mm)||Standard Error|Least Squares Mean
2605120|NCT02113579|Secondary|Global Subjective VAS Score at Week 2|"At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows:Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that elicit your dentinal hypersensitivity pain/discomfort since you have been using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.|||units on a scale (mm)||Standard Error|Least Squares Mean
2605121|NCT02113579|Secondary|Mean Tactile Sensitivity VAS Score at Week 4|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.|||units on a scale (mm)||Standard Error|Least Squares Mean
2605122|NCT02113579|Secondary|Mean Tactile Sensitivity VAS Score at Week 2|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.|||units on a scale (mm)||Standard Error|Least Squares Mean
2605123|NCT02113579|Secondary|Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 2 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score.|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.|||percentage of participants|||Number
2605124|NCT02113579|Secondary|Mean Tactile Sensitivity Score at Week 2|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.|||grams||Standard Error|Least Squares Mean
2605125|NCT02113579|Secondary|Mean Cold Air Stimulus VAS Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.|||units on a scale (mm)||Standard Error|Least Squares Mean
2605126|NCT02113579|Secondary|Mean Tactile Sensitivity Score at Week 4|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.|4 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.|||grams||Standard Error|Least Squares Mean
2605579|NCT02108171|Other Pre-specified|Time to Spontaneous Breathing of Patients Receiving Intranasal Placebo|Time to spontaneous breathing of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and adequate ventilation|1 day||||minutes|||Number
2605127|NCT02113579|Secondary|Mean Cold Air Stimulus VAS Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 Weeks|Analysis was based on the Full Analysis Set, which included all randomized subjects.|||units on a scale (mm)||Standard Error|Least Squares Mean
2605128|NCT02113579|Primary|Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 4 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score.|4 Weeks|Analysis was based on Full Analysis Set, which included all randomized subjects.|||percentage of participants|||Number
2605129|NCT02113449|Primary|Provide a Score From 1-7 to Some Statements, Depending on How Much You Think Each Statement Applies or Does Not Apply to the Spray Product That You Used|A score of 1 indicates that the statement does not apply at all to the product that you used. A score of 7 indicates that it applies completely to it. You can use any score from 1 to 7 to indicate how much or how little you think the statement applies to this product|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
2605130|NCT02113449|Primary|How Often do You Think This Spray Product Would Last for You Personally?|There was one questionnaire used in this study which is divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
2605131|NCT02113449|Primary|Which One Statement Best Describes How Often, if Ever, You Think You Would Buy the Spray Product in the Future?|There was one questionnaire used in this study which is divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
2605132|NCT02113449|Primary|How Many Packages Would You Buy?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience.This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
2605133|NCT02113449|Primary|If the Product You Just Tried (After At-home Use) Was Available for the Following Price: $12.99 for 40 Doses, How Likely Would You be to Buy it?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
2605134|NCT02113449|Primary|Divide 11 Points Between Two Products (CO2 Nasal Spray and Brand Selected at Q1)?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option. It was done to compare the spray with the product selected by the participant in Q1. There were 11 points between the two products that participants could divide anyways thet wanted (11-0, 10-1, 9-2, 8-3, 7-4 or 6-5 etc). The more the participant liked a product compared to other, the higher the number of points were to be given to that product.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
2605135|NCT02113449|Primary|Which of the Following Statements Best Describes the Extent to Which the Spray Reached Your Expectations?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after at-home use of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
2605136|NCT02113449|Primary|Would You be Interested in Taking the Spray Product Home and Using it Over the Next Week?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first dose of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
2605137|NCT02113449|Primary|If the Product You Just Tried (After First Dose) Was Available for the Following Price: $12.99 for 40 Doses, How Likely Would You be to Buy it?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first dose of the product. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
2605138|NCT02113449|Primary|Which of the Statements Best Describes the Extent to Which the Spray Reached Your Expectations?|There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked after the first use. Participants could select only one option.|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that did not perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
2605139|NCT02113449|Primary|Which One Product That Relieves Nasal Congestion do You Buy Most Often?|"There was one questionnaire used in this study which was divided into 3 parts: screening survey, after product trial questions, and at home usage experience. This question was asked as part of screening survey prior to concept viewing. If the participant answered I do not purchase any product to relieve congestion the participant was excluded. Participants could select only one option available."|7 days|The per protocol (PP) population was the primary population for analysis. Of the 143 participants who completed this study, 10 participants had device failure (device that didnot perform well), and therefore 133 participants were included in PP population.|||Participants|||Number
2605140|NCT02113436|Secondary|Mean Change From Baseline in Total Asthma Symptom Score (Daytime Plus Night Time) at the End of the Treatment Period 2 (TP2)|The participant's parent or legally acceptable representative recorded asthma symptoms experienced by the participant in a patient diary twice daily (daytime and night time) in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP2 (Week 24). Scores ranged from 0 (none) to 3 (severe) and maximum score is 6 per day. Change from Baseline in the asthma symptom scores at daytime plus night time at the end of TP2 was analyzed. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 [Randomization]).The end of the TP2 value is a mean value of the last 7 consecutive days during the TP2 (excluding the last day of the TP2). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who received at least one dose of open-label medication in the TP2 were analyzed.|Baseline and Week 24|ITT Population|||Scores on a scale||Standard Deviation|Mean
2605141|NCT02113436|Secondary|Mean Change From Baseline in Use of Rescue Medication (Percentage of Days With Rescue-free 24-hour Period) at the End of Treatment Period 1 (TP1)|The number of inhalations of rescue salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participant's parent or legally acceptable representative twice daily in a patient diary. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 8-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the patient diary prior to the randomization of the participant. Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.|Baseline and Week 8|ITT Population|||Percentage of days||Standard Error|Least Squares Mean
2605142|NCT02113436|Secondary|Mean Change From Baseline in Use of Rescue Medication (Number of Occasions Used During a 24-hour Period) in Treatment Period 1 (TP1)|The number of inhalations of rescue salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participant's parent or legally acceptable representative twice daily in a patient diary from Baseline (Week -1) until Week 8. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 8 weeks in TP1 were assessed. The Baseline value was derived from the last 7 days of the patient diary prior to the randomization of the participant. Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.|Baseline and Week 8|ITT Population|||Occasions per 24 hours||Standard Error|Least Squares Mean
2605143|NCT02113436|Secondary|Mean Change From Baseline in Japanese Pediatric Asthma Control Program (JPAC) Score at the End of Treatment Period 1 (TP1)|Severity and control statuses based on Japanese pediatric guideline for the treatment and management of asthma (JPGL) can be assessed according to JPAC. Theoretically range of JPAC score was 0 (poor control) to 18 (complete control) point. JPAC questionnaire was recorded at Baseline (Week -2) and Week 8 by the participant's parent or legally acceptable representative who knew the participant's asthma for the last month. Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 were analyzed.|Baseline and Week 8|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2605144|NCT02113436|Secondary|Number of Participants With at Least One Asthma Exacerbation in Treatment Period 1 (TP1)|The definition of exacerbations was amended during the study. <Original> An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (oral, parenteral, or depot) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. <Amendment> An asthma exacerbation is defined as deterioration of asthma requiring the use of prednisone or hydrocortisone equivalent systemic corticosteroids for at least 3 days, or requiring the use of dexamethasone or betametasone equivalent systemic corticosteroids (oral, intravenous or intramuscular), or requiring the use of systemic depot corticosteroids once, or an in-patient hospitalization that required treatment for respiratory symptom with wheezing, or emergency department visit due to asthma that required intravenous systemic corticosteroids.|Up to 8 weeks|ITT Population|||Participants|||Number
2605677|NCT02107339|Secondary|Pain Scores Postanesthesia Care Unit (PACU) Arrival|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|First 5 minutes after PACU arrival||||units on a scale||Inter-Quartile Range|Median
2605145|NCT02113436|Secondary|Mean Change From Baseline in Daytime Asthma Symptoms Score at the End of Treatment Period 1 (TP1)|The participant's parent or legally acceptable representative recorded asthma symptoms experienced by the participant during the day in a patient diary in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP1 (Week 8). Scores ranged from 0 to 3(0: one, 1: mild, 2: moderate, 3: severe) and maximum score is 3 per day. Change from Baseline in the asthma symptom scores at day time at the end of TP1 was analyzed. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 [Randomization]). The end of the TP1 value is a mean value of the last 7 consecutive days during the TP1 (excluding the last day of the TP1). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.|Baseline and Week 8|ITT Population.|||Scores on a scale||Standard Error|Least Squares Mean
2605146|NCT02113436|Secondary|Mean Change From Baseline in Night-time Asthma Symptoms Score at the End of Treatment Period 1 (TP1)|The participant's parent or legally acceptable representative recorded asthma symptoms experienced by the participant during the night in a patient diary in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP1 (Week 8). Scores ranged from 0 to 3(0: one, 1: mild, 2: moderate, 3: severe) and maximum score is 3 per day. Change from Baseline in the asthma symptom scores at night time at the end of TP1 was analyzed. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 [Randomization]). The end of the TP1 value is a mean value of the last 7 consecutive days during the TP1 (excluding the last day of the TP1). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.|Baseline and Week 8|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2605147|NCT02113436|Primary|Mean Change From Baseline in Total Asthma Symptom Score (Daytime Plus Night Time) at the End of the Treatment Period 1 (TP1)|The participant's parent or legally acceptable representative made entries asthma symptom experienced by the participant in a patient diary twice daily (day time and night time) in the form of scores on a 4-point rating scale from Baseline (Week -1) until end of TP1 (Week 8). Scores ranged from 0 to 3(0: one, 1: mild, 2: moderate, 3: severe) and maximum score is 6 per day. The Baseline value is a mean value of the last 7 consecutive days during the run-in period (excluding the day of Visit 2 [Randomization]). The end of the TP1 value is a mean value of the last 7 consecutive days during the TP1 (excluding the last day of the TP1). Change from Baseline is the difference between the value of the endpoint at the time point of interest and the Baseline value. Participants who completed TP1 and completed their diary were analyzed.|Baseline and Week 8|ITT Population: all randomized par. who received at least one dose of study medication.|||Scores on a scale||Standard Error|Least Squares Mean
2605148|NCT02113410|Secondary|Life Satisfaction Index-Short Form (LSITA-SF)|The Life Satisfaction Index-Short Form was administered to measure general life satisfaction in participants. The 12-item index offers a 6-point scale for each item (1 = strongly agree to 6 = strongly disagree; for Items 2, 4, 5, and 6, the responses are reversed. It ranges 12 (minimum)-72 (maximum); higher scores indicate higher level of life satisfaction. Reliability of this instrument when used with 654 older adults produced a Cronbach's alpha of .95, with a goodness of fit of > .90. It has a correlated reliability of .90 with the long form.|6 months|Community-dwelling Older adults (age 65 years or older) who are diagnosed with osteoarthritis.|||score on a scale||Standard Deviation|Mean
2605149|NCT02113410|Secondary|PROMIS Ability to Participate in Social Activities|The PROMIS Ability to Participate in Social Activities-V 2.0- SF-8a was administered to measure the perceived ability to perform usual social roles and activities. Items are worded negatively in terms of perceived limitations (5 = Never to 1 = Always), but responses are reverse-coded .Scores can range from 8 to 40; higher scores indicate lower ability to participate in social roles.|6 months|Community-dwelling Older adults (age 65 years or older) who are diagnosed with osteoarthritis.|||score on the scale||Standard Deviation|Mean
2605150|NCT02113410|Secondary|PROMIS Fatigue Scale|The PROMIS Fatigue scale was administered to evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that decreases ability to execute daily activities and to function normally in family or social roles.It ranges 8-40 and higher scores indicate higher level of fatigue.|6 months|Community-dwelling Older adults (age 65 years or older) who are diagnosed with osteoarthritis.|||score on the scale||Standard Deviation|Mean
2605151|NCT02113410|Secondary|PROMIS Emotional Distress-Depression (Short Form)|The PROMIS Emotional Distress and Depression-V 1.0-Short Form-8a was administered o measure depressive symptoms. The tool has a 5-point scale for each item (1 = Never to 5 = Always); scores can range from 8 to 40. Higher scores indicate higher levels of depression and emotional distress.|6 months|Community-dwelling Older adults (age 65 years or older) who are diagnosed with osteoarthritis.|||scores on a scale||Standard Deviation|Mean
2605152|NCT02113410|Secondary|6-Minute Walk Test|The 6-Minute Walk Test was administered to measure changes in exercise tolerance in participants. The tool measured the distance(yards) a participant walked in 6 minutes on a hard and flat surface. Less distances (yards) covered in 6 minutes indicate lower function.|6 months|Community-dwelling Older adults (age 65 years or older) who are diagnosed with osteoarthritis.|||yards||Standard Deviation|Mean
2605153|NCT02113410|Secondary|Berg Balance Scale|The Berg Balance Scale was administered to measure changes in balance function. The performance-based Berg Balance Scale contains 14 items applying a 5-point scale for each item (0 = lowest level of function to 4 = highest level of function); scores range from 0 to 56. Higher scores indicate higher fall risk. The Berg Balance Scale is the gold standard assessment of balance, obtaining good to excellent intra-rater reliability (ICC = 0.68-0.99) and interrater reliability (ICC = 0.88-0.98) and good internal validity.|6 months|Community-dwelling Older adults (age 65 years or older) who are diagnosed with osteoarthritis.|||scores on a scale||Standard Deviation|Mean
2605154|NCT02113410|Secondary|Gait Speed Test|The Gait Speed Test was used to measure physical function. Gait speed measurement is considered highly reliable in older adults without known impairments that should affect gait. For measuring gait speed, the unit of measurement is the second. Intrarater reliability (N = 19-24) and test-retest reliability (N = 19-41) have been reported as high (ICC = .90-.96, r = 89-100). The Pearson correlation coefficient is r = .93 and ICC = .78 for test-retest reliability for gait speed in older adults.|6 months|Community-dwelling Older adults (age 65 years or older) who are diagnosed with osteoarthritis.|||time (second)||Standard Deviation|Mean
2605155|NCT02113410|Secondary|PROMIS Physical Function|The PROMIS Physical Function Short Form-V 1.0-12a was administered to measure physical function. The domain of physical function assesses self-reported ability rather than actual performance of physical activities. Scores can range from 7 (minimum) to 60 (maximum). The higher scores represent better physical function.This includes functioning of upper extremities (dexterity), lower extremities (mobility), and central regions (neck back), as well as instrumental activities of daily living. Each question has five response options, ranging in value from 1 (unable to do) to 5 (able to do without any difficulty).|6 months|Community-dwelling Older adults (age 65 years or older) who are diagnosed with osteoarthritis.|||score on a scale||Standard Deviation|Mean
2605156|NCT02113410|Primary|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)|The Western Ontario and McMaster Universities Osteoarthritis Index was administered to measure self-reported. The tool, recommended for osteoarthritis clinical trials, is a self-administered scale with 24 questions using a Likert-type scale. The Western Ontario and McMaster Universities Osteoarthritis Index was administered to measure self-reported OA symptoms (pain, stiffness, functional ability). The tool is a self-administered scale with 24 items (pain [5 items], stiffness [2 items], physical function [17 items]). A score range for each subscale for each scale (minimum-maximum) is Pain 0-20, stiffness 0-8, physical function 0-68. Higher scores indicate worse pain, stiffness, and functional limitations. For this study, we used a subscale of pain (5 items), stiffness (2 items), physical function (17 items). A total score of all subscales can range from 0 (minimum) to 96 (maximum). The WOMAC demonstrated a Cronbach's alpha of .95 for persons with OA.|6 months|Community-dwelling Older adults (age 65 years or older) who are diagnosed with osteoarthritis.|||score on a scale||Standard Deviation|Mean
2605157|NCT02113410|Primary|PROMIS Pain Interference|The 8-item PROMIS Pain Inference-Short Form- V. 1.0-8a was administered to measure self-reported consequences of pain on various aspects of the participant's life.Scores can range from 8 (minimum) to 40 (maximum) and higher scores indicate more interference with daily activities. This tool is normed on the U.S. general population, with an average score of 50 and a standard deviation of 10, to report interference within the previous 7 days on 5-point response scale ranging from not at all to very much. This self-report measure was developed by the NIH. NIH has rigorously tested the construct validity and reliability of all of the PROMIS tools and all have been shown to be internally consistent, reliable (reliability = .96 to .99, for PROMIS-PI SF) and valid (construct validity). A higher score represent a severe pain level.|6 months|Community-dwelling Older adults (age 65 years or older) who are diagnosed with osteoarthritis.|||score on a scale||Standard Deviation|Mean
2605158|NCT02113189|Other Pre-specified|Change in Daily Activity as Measured by Steps Per Day|Participants will be asked to wear a pedometer for 7 days at designated times in study. Total steps per day will be recorded.|Total steps per day will be measured at the start of the study and a week prior to testing at 6 months, and 12 months|This was a self-reported data set. Patients had logs to record daily steps from pedometers for each week. Data was not reported accurately from all participants, thus data set is incomplete. Analysis cannot be completed.||||||
2605159|NCT02113189|Secondary|Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System|Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze temporal and spatial parameters.|Testing will be done at initial testing and 12 months||||cm/sec||Full Range|Mean
2605160|NCT02113189|Primary|Change in Distance Walked on 6-Minute Walk Test (6MWT)|Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary.|6MWT will be done at initial testing and 12 months||||feet||Full Range|Mean
2605161|NCT02113124|Primary|Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating|5 ml of blood will be acquired following a 8-hour fasting period to determine baseline concentrations of amino acids. A meal will then be provided and another blood sample will be acquired 90 minutes after completing the meal to examine the change in amino acid concentration. These samples will be used to determine the levels of each essential amino acid present.|Samples collected on day 1 following 8 hour fasting period and again 90 minutes after eating a predetermined meal||||µM||Standard Error|Mean
2605162|NCT02113007|Secondary|Number of Participants With Serious and Non-serious Adverse Events as a Measure of Safety.|Patients in the safety lead-in part of the study were monitored for up to 2 treatment cycles (4 weeks) to assure there were no unexpected or prohibitive toxicities. A non-serious adverse event is any untoward medical occurrence. A serious adverse event (SAE) is an event that meets one or more of the following: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; requires intervention to prevent permanent impairment or damage. Specific AE and SAE terms are provided in the Adverse event module.|up to 4 weeks||||participants|||Number
2605163|NCT02113007|Secondary|Progression Free Survival (PFS)|Six and twelve-month CNS progression-free survival rate.|6 and 12 months|The study closed early due to slow accrual; outcome measure not reached.||||||
2605164|NCT02113007|Primary|Overall Response Rate|Patients will be assessed for response by MRI of brain and/or spine after 4 cycles (8 weeks) of treatment according to Response Criteria for Primary CNS Lymphoma. Patients with stable disease or better (CR or PR) will continue treatment for 12 cycles (24 weeks). Complete Response (CR)=no contrast enhancement, normal eye exam. Partial Response (PR)=50 percent decrease in tumor enhancement, minor retinal pigment epithelium abnormality in eye exam. Stable disease (SD)= a change in lesion size that is neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for progressive disease.|approximately 32 weeks|The study closed early due to slow accrual. This outcome measure was not reached.||||||
2605173|NCT02112877|Other Pre-specified|Number of Participants With Late Technical Success|Late technical success (through 12 months) is the absence of device movement >10mm related to anatomical landmarks or any migration leading to symptoms or requiring therapy; absence of stent occlusion by thrombosis or restenosis, defined as reduction in treated segment lumen more than 50% from the post-procedure vessel lumen diameter as measured by post-procedural venogram or DUS and maintenance of structural integrity, defined as the absence of pinching (focal compression), kinking (stent doubling or bending upon itself) that results in >50% diameter reduction of the stent, recoil (poor radial resistive force) or absence of fractures .|12 months post-intervention|For the feasibility cohort, month 12 outcomes were available for 22 subjects. For the pivotal cohort, only 127 subjects had a 12-month venogram and/or stent fracture assessment.|||Participants|||Count of Participants
2605165|NCT02112994|Secondary|Shift In Child-Pugh Status From Baseline To Week 144|In order to evaluate the effects of sebelipase alfa on liver function, the number of participants with a shift in Child-Pugh status from Baseline to Week 144 is reported. The status is based on the Child-Pugh score, which is used in clinical practice to assess prognosis in individuals with chronic liver disease. Laboratory data were used in derivation of the score by summing individual scores (scored 1-3, with 3 indicating most severe) from clinical laboratory test results and physical examinations, including total serum bilirubin, serum albumin, prothrombin time, ascites, and hepatic encephalopathy. The total score was used to determine the Child-Pugh status, reported as Class A (score of 5 or 6), Class B (score of 7 to 9), or Class C (score of 10 to 15). Higher scores and higher categories represented a worse outcome. Data reported as 1 of 2 types of shifts in class: No Change from Baseline; Decline from Baseline.|Baseline, Week 144|Full Analysis Set: All participants who received at least 1 infusion of sebelipase alfa. The full analysis set was used for analysis of safety and efficacy.|||Participants|||Count of Participants
2605166|NCT02112994|Secondary|Percent Change In Body Mass Index (BMI)-For-Age Percentile From Baseline To Week 144 In Pediatric Participants|To evaluate the effects of sebelipase alfa on growth parameters in pediatric participants (≤18 years old) presenting with evidence of growth delay, the percent change in the anthropometric parameter of BMI-for-age percentile from Baseline to Week 144 is reported. Anthropometric parameters were plotted on standard growth curves. When possible, historical data on growth parameters was also incorporated into the analyses. Percentiles and Z-scores for BMI-for-age were determined using standard growth charts appropriate to a participant's age on the date of the assessment: the World Health Organization standard growth chart for participants ≤2 years of age and the Centers for Disease Control standard growth chart for participants >2 years of age.|Baseline, Week 144|Full Analysis Set: All pediatric participants who received at least 1 infusion of sebelipase alfa. The full analysis set was used for analysis of safety and efficacy.|||Percent Change||Standard Deviation|Mean
2605167|NCT02112994|Secondary|Participants Testing Positive For Anti-drug Antibodies (ADAs)|The impact of ADAs on the safety and immunogenicity of sebelipase alfa was evaluated by testing for ADAs in participants who received sebelipase alfa in this open-label study. Blood samples for assessment were collected prior to study infusions at Week 2, Week 4, Week 8, Week 12, and every 12 weeks thereafter. Participants testing positive for ADAs were also tested for the presence of neutralizing antibodies that inhibited sebelipase alfa enzyme activity and/or cellular uptake. Any participant experiencing a moderate or severe infusion-associated reaction (IAR) was to have an additional assessment of ADAs at the next study visit (prior to study drug infusion); these participants were to also have serum samples collected at 1 to 2 hours after IAR onset and at the next study visit (prior to study drug infusion) for analysis of serum tryptase. The count of participants who became ADA positive and who tested positive for neutralizing antibodies are presented.|Week 144|Full Analysis Set: All participants who received at least 1 infusion of sebelipase alfa. The full analysis set was used for analysis of safety and efficacy.|||Participants|||Count of Participants
2605168|NCT02112994|Secondary|Percent Change In Serum Lipids From Baseline To Week 144|The effect of sebelipase alfa on lipid metabolism was evaluated by measuring the change from baseline to Week 144 in 4 serum lipids: low-density lipoprotein cholesterol (LDL-C); high-density lipoprotein cholesterol (HDL-C); non-HDL-C; triglycerides. Blood samples for these clinical laboratory tests were collected at scheduled time points and analyzed by a central laboratory.|Baseline, Week 144|Full Analysis Set: All participants who received at least 1 infusion of sebelipase alfa. The full analysis set was used for analysis of safety and efficacy.|||Percent Change||Full Range|Median
2605169|NCT02112994|Primary|Participants Experiencing Severe Treatment-emergent Adverse Events (TEAEs)|The number of participants experiencing severe TEAEs is presented for participants who received sebelipase alfa in this open-label study. Adverse events (AEs) information was obtained at each scheduled contact with the participant (or participant's parent or legal guardian). An AE was defined as any untoward medical occurrence that did not require a causal relationship with study drug administration. An AE could have been any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. Pre-existing conditions that worsened in severity during the study were reported as AEs. A summary of all serious and other non-serious AEs regardless of causality is located in the Reported AE module. Severity assessed using Clinical Data Interchange Standards Consortium Study Data Tabulation Model standard terminology v3.1.1. Data presented only according to age group, not dose of study drug received.|Screening, Week 144|Full Analysis Set: All participants who received at least 1 infusion of sebelipase alfa. The full analysis set was used for analysis of safety and efficacy.|||Participants|||Count of Participants
2605170|NCT02112877|Other Pre-specified|Number of Participants With Estimated Secondary Patency|"Secondary patency is defined as freedom from permanent loss of patency determined through last follow-up (irrespective of the number of interventions)."|60 months post-intervention||2022-03-31|03/2022||||
2605171|NCT02112877|Other Pre-specified|Number of Participants With Estimated Primary-Assisted Patency|Primary-assisted patency is defined as freedom from occlusion regardless of whether an intervention (subsequent to the index procedure) was performed.|12 months post-intervention|For the feasibility cohort, only 21 subjects had known outcomes. For the pivotal cohort, only 126 subjects had known outcomes.|||Participants|||Count of Participants
2605172|NCT02112877|Other Pre-specified|Change in the Quality of Life (Chronic Venous Insufficiency Questionnaire)(CIVIQ2))|The overall change in CIVIQ2 scores for the study patients, calculated using the mean scores at baseline and 12-months. This instrument is scored from 20 to 100 points with lower scores indicating a lesser impact on health.|Baseline and 12 months post-intervention|For the feasibility cohort, three subjects did not have Month 12 CIVIQ-2 results. For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues. Also, 11 subjects did not have a Month 12 visit and 2 subjects did not complete the CIVIQ forms.|||units on a scale||95% Confidence Interval|Mean
2605174|NCT02112877|Other Pre-specified|Number of Participants With Procedural Success|Procedural success is defined as procedural technical success without the occurrence of a major adverse event (MAE) between the index procedure and discharge.|From the time of the Index Procedure post procedural venogram through the time of Index Procedure Discharge or 3 days Post-Procedure (whichever comes first)|For the pivotal cohort, four subjects did not have the post-procedural venogram available for assessment.|||Participants|||Count of Participants
2605678|NCT02107339|Secondary|Hydromorphone Use Third 24 Hours||48-72 hours after surgery||||milligrams||Inter-Quartile Range|Median
2605176|NCT02112877|Other Pre-specified|Number of Participants With Procedural Technical Success|Procedural technical success is achievement of a final residual target vessel diameter stenosis of ≤50% as measured on the post procedural venogram, without skipped lesion regions, with placement of the study device alone with or without post-stenting balloon dilation as needed.|During Procedure|For the pivotal cohort, four subjects did not have the post-procedural venogram available for assessment. Additionally, there were two subjects that failed the endpoint due to two investigators using non-study stents.|||Participants|||Count of Participants
2605177|NCT02112877|Secondary|Number of Participants With Improvement in Venous Clinical Severity Score (VCSS)|The secondary effectiveness endpoint for this study will be a binary response variable based on an improvement in Venous Clinical Severity Score (VCSS) by at least 50% at 12 months post-intervention. VCSS measures 10 clinical attributes of venous disease (Pain, Varicose Veins, Venous Edema, Skin Pigmentation, Inflammation, Induration, No. Active Ulcers, Active Ulcer Size, Ulcer Duration and Compression Therapy) on a scale of 0 - 3 (Absent 0, Mild 1, Moderate 2, and Severe 3).|12 months post-intervention|For the feasibility cohort, 7 subjects did not have VCSS results at both month 12 and baseline. For the pivotal cohort, results for 24 subjects from a single US center are not included due to data integrity issues and 14 subjects did not have VCSS results at both month 12 and Baseline.|||Participants|||Count of Participants
2605178|NCT02112877|Primary|Percentage of Participants That Demonstrated Primary Patency|The primary effectiveness endpoint is the primary patency rate at 12 months post-intervention, defined as freedom from occlusion by thrombosis, freedom from surgical or endovascular intervention on target vessel which are found to have re-stenosis or stent occlusion to maintain patency, and freedom from in-stent stenosis more than 50% by venogram.|12 months post-intervention|For the feasibility cohort, month 12 outcomes were available for 22 subjects. For the pivotal cohort, month 12 outcomes were available for 125 subjects. Those without venography performed at 12 months had their result assigned by random selection from subjects with a venogram result who had the same anatomy and the same DUS outcome (if available).|||Percentage of Participants|||Number
2605179|NCT02112877|Primary|Number of Participants With Major Adverse Events (MAE)|The primary safety endpoint for this study will be a composite endpoint of any major adverse event (MAE) within 30 days, as adjudicated by a Clinical Events Committee.|30 days|For the pivotal cohort, one subject never returned for follow-up after discharge.|||Participants|||Count of Participants
2605180|NCT02112838|Secondary|Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 24 Weeks (Visit 9).|Shift in haematuria (dipstick test) from Baseline (Visit 2) at 24 weeks (Visit 9).|Baseline to Week 24||||subjects|||Number
2605181|NCT02112838|Secondary|Shift in Haematuria (Dipstick Test) From Baseline (Visit 2) at 12 Weeks (Visit 7).|Shift in haematuria (dipstick test) from Baseline (Visit 2) at 12 weeks (Visit 7).|Baseline to Week 12||||subjects|||Number
2605182|NCT02112838|Secondary|Percentage of Subjects With sPCR <50 mg/mmol (500 mg/g) at 12 Weeks (Visit 7).|Percentage of subjects with sPCR <50 mg/mmol (500 mg/g) at 12 weeks (Visit 7).|Baseline to Week 12||||percentage of subjects|||Number
2605183|NCT02112838|Secondary|Mean Change From Baseline (Visit 2) of Proteinuria at 12 Weeks (Visit 7).|Mean change from Baseline (Visit 2) of proteinuria at 12 weeks (Visit 7).|Baseline to Week 12||||mg/g||Standard Error|Least Squares Mean
2605184|NCT02112838|Secondary|Mean Change From Baseline (Visit 2) of eGFR at 24 Weeks (Visit 9).|Mean change from Baseline (Visit 2) of eGFR at 24 weeks (Visit 9).|Baseline to Week 24||||eGFR (mL/min/1.73 m2)||Standard Error|Least Squares Mean
2605185|NCT02112838|Secondary|Mean Change From Baseline (Visit 2) of eGFR at 12 Weeks (Visit 7).|Mean change from Baseline (Visit 2) of eGFR at 12 weeks (Visit 7).|Baseline to Week 12|Analysis population includes only subjects who completed visits through Week 12.|||eGFR (mL/min/1.73 m2)||Standard Error|Least Squares Mean
2605186|NCT02112838|Secondary|Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Cellular/Fibrocellular Crescent Score on Renal Biopsies.|Mean change from pre-treatment to post-treatment in cellular/fibrocellular crescent score on renal biopsies. Biopsy specimens with a minimum of 8 glomeruli, mesangial hypercellularity (M), segmental sclerosis (S), and interstitial fibrosis/tubular atrophy (T) lesions are scored using the Oxford Classification of IgA nepthropathy (IgAN) system for assessing histologic findings in IgAN.|Baseline to Week 24|Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected.|||Percentage of glomeruli|renal biopsy samples|Standard Error|Least Squares Mean
2605187|NCT02112838|Secondary|Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Tubulointerstitial Scarring (T) on Renal Biopsies.|"Mean change from pre-treatment to post-treatment in mesangial hypercellularity on renal biopsies. Using the Oxford Classification of IgA Nepthropathy (IgAN), biopsy specimens with a minimum of 8 glomeruli, mesangial hypercellularity (M), endocapillary hypercellularity (E), segmental sclerosis (S), and interstitial fibrosis/tubular atrophy (T) lesions are scored for assessing histologic findings in IgAN.~T= Percentage of cortical area involved by the tubular atrophy or interstitial fibrosis, whichever is greater. A decrease in score equates to improvement from IgAN disease."|Baseline to Week 24|Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected.|||Percentage of glomeruli|renal biopsy samples|Standard Error|Least Squares Mean
2605188|NCT02112838|Secondary|Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Global Glomerulosclerosis Score on Renal Biopsies.|"Mean change from pre-treatment to post-treatment in mesangial hypercellularity on renal biopsies. Using the Oxford Classification of IgA Nepthropathy (IgAN), biopsy specimens with a minimum of 8 glomeruli, mesangial hypercellularity (M), endocapillary hypercellularity (E), segmental sclerosis (S), and interstitial fibrosis/tubular atrophy (T) lesions are scored for assessing histologic findings in IgAN.~Percentage of any amount of the tuft involved in sclerosis, but not involving the whole tuft or the presence of an adhesion in each glomeruli. A decrease in score equates to improvement from IgAN disease."|Baseline to Week 24|Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected.|||Percentage of glomeruli|renal biopsy samples|Standard Error|Least Squares Mean
2605206|NCT02112045|Secondary|Number of Participants With Neutrophil Engraftment|Neutrophil engraftment is defined as ANC ≥ 0.5 × 10^9/L × 3 consecutive daily assessments. The first of 3 consecutive days for which ANC ≥ 0.5 × 109/L will be recorded as the date of neutrophil engraftment. Time to neutrophil engraftment will be calculated as the time from the date of the ASCT to the date of neutrophil engraftment.|Up to Day 30||||Participants|||Count of Participants
2605189|NCT02112838|Secondary|Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Segmental Sclerosis/Adhesion (S) on Renal Biopsies.|"Mean change from pre-treatment to post-treatment in mesangial hypercellularity on renal biopsies. Using the Oxford Classification of IgA Nepthropathy (IgAN), biopsy specimens with a minimum of 8 glomeruli, mesangial hypercellularity (M), endocapillary hypercellularity (E), segmental sclerosis (S), and interstitial fibrosis/tubular atrophy (T) lesions are scored for assessing histologic findings in IgAN.~S = Percentage of any amount of the tuft involved in sclerosis, but not involving the whole tuft or the presence of an adhesion in each glomeruli. A decrease in score equates to improvement from IgAN disease."|Baseline to Week 24|Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected.|||Percentage of glomeruli|renal biopsy samples|Standard Error|Least Squares Mean
2605190|NCT02112838|Secondary|Mean Change From Pre-treatment to Post-treatment in Percentage of Glomeruli With Endocapillary Hypercellularity (E) on Renal Biopsies.|"Mean change from pre-treatment to post-treatment in mesangial hypercellularity on renal biopsies. Using the Oxford Classification of IgA Nepthropathy (IgAN), biopsy specimens with a minimum of 8 glomeruli, mesangial hypercellularity (M), endocapillary hypercellularity (E), segmental sclerosis (S), and interstitial fibrosis/tubular atrophy (T) lesions are scored for assessing histologic findings in IgAN.~E = Percentage of glomeruli eypercellularity due to increased number of cells within glomerular capillary lumina causing narrowing of the lumina. A decrease in score equates to improvement from IgAN disease."|Baseline to Week 24|Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected.|||Percentage of glomeruli|renal biopsy samples|Standard Error|Least Squares Mean
2605191|NCT02112838|Secondary|Percentage of Subjects With ≥ 30% Reduction in Proteinuria From Baseline (Visit 2) at 24 Weeks (Visit 9).|Percentage of subjects with ≥ 30% reduction in proteinuria from Baseline (Visit 2) at 24 weeks (Visit 9).|Baseline to Week 24||||Participants|||Count of Participants
2605192|NCT02112838|Secondary|Percentage of Subjects With ≥50% Reduction in sPCR From Baseline (Visit 2) at Week 24 (Visit 9).|Percentage of subjects with ≥50% reduction in sPCR from Baseline (Visit 2) at Week 24 (Visit 9)|Baseline to Week 24||||Participants|||Count of Participants
2605193|NCT02112838|Secondary|Mean Change From Pre-treatment to Post-treatment in Mesangial Hypercellularity (M) on Renal Biopsies.|"Mean change from pre-treatment to post-treatment in mesangial hypercellularity on renal biopsies. Using the Oxford Classification of IgA Nepthropathy (IgAN), biopsy specimens with a minimum of 8 glomeruli, mesangial hypercellularity (M), endocapillary hypercellularity (E), segmental sclerosis (S), and interstitial fibrosis/tubular atrophy (T) lesions are scored for assessing histologic findings in IgAN.~M = the mean score based on Oxford Classification system score is based on total count of mesangial cells for all glomeruli (count of <4=0 score, 4 to 5=1, 6 to 7=2, ≥8=3). A decrease in score equates to improvement from IgAN disease."|Baseline to Week 24|Analysis population includes only subjects with both pre-treatment and post-treatment biopsies collected.|||mesangial hypercellularity score|renal biopsy samples|Standard Error|Least Squares Mean
2605194|NCT02112838|Primary|Mean Change of Proteinuria as Measured by Spot Urine Protein/Creatinine Ratio (sPCR) at Week 24|Mean change from Baseline (Visit 2) of proteinuria as measured by the spot Protein-Creatinine Ratio (sPCR) at 24 weeks (Visit 9) for the ITT Population|Baseline to 24 weeks||||mg/g||Standard Error|Least Squares Mean
2605195|NCT02112448|Secondary|Length of Stay|Length of stay will be recorded for each subject.|From date of randomization until the date of first documented progression or date of death from any cause or discharge, whichever came first, assessed up to 100 months||||days||Standard Deviation|Mean
2605196|NCT02112448|Primary|Total Morphine Dosage|Total dose of morphine used will be recorded for each patient.|24 hours||||mg/kg||Standard Deviation|Mean
2605197|NCT02112370|Secondary|Pain Killer Dose|Change in pain killer usage with time|0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation||||vials (15mg ketorolac per vial)||Standard Deviation|Mean
2605198|NCT02112370|Secondary|NRS Change|"Change in NRS score a with time The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location.~Range: 0(minimal pain, better outcome) ~ 10(maximum pain, worse outcome)"|0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operation||||scores on a scale||Standard Deviation|Mean
2605199|NCT02112370|Secondary|Operation Time|The amount of time taken from start to the end of surgery|participants were followed for the duration of the operation, an average of approximately 2.5 hours||||minutes||Standard Deviation|Mean
2605200|NCT02112370|Secondary|Blood Loss Amount|The blood loss amount is estimated at the end of surgery.|participants were followed for the duration of the operation, an average of approximately 2.5 hours||||ml||Standard Deviation|Mean
2605201|NCT02112370|Secondary|Maximum of Measured Heart Rates|The maximal heart rate is monitored during surgery.|participants were followed for the duration of the operation, an average of approximately 2.5 hours||||beats per minute||Standard Deviation|Mean
2605202|NCT02112370|Secondary|Maximum of Measured Diastolic Blood Pressures|The maximal diastolic blood pressure is monitored during surgery.|participants were followed for the duration of the operation, an average of approximately 2.5 hours||||mmHg||Standard Deviation|Mean
2605203|NCT02112370|Secondary|Maximum of Measured Systolic Blood Pressures|The maximal systolic blood pressure is monitored during surgery.|participants were followed for the duration of the operation, an average of approximately 2.5 hours||||mmHg||Standard Deviation|Mean
2605204|NCT02112370|Primary|NRS Pain Scores for the First 12 Hours|"The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location.~Range: 0(minimal pain, better outcome) ~ 10(maximum pain, worse outcome)~Unlike the general NRS pain score as reported in the post-operative 48 hour result which deals with post-operative discomfort in general, this outcome measures the pain score of the specific location in which flap dissection had taken place."|Postoperative 12 hours||||points||Standard Deviation|Mean
2605205|NCT02112045|Secondary|Number of Participants With Platelet Engraftment|Platelet engraftment is defined as an untransfused platelet measurement >20,000/mm3 × 3 consecutive daily assessments. The first of 3 consecutive days for which the untransfused platelet measurement is >20,000/mm3 will be recorded as the date of platelet engraftment. Time to platelet engraftment will be calculated as the time from receiving the date of ASCT to the date of platelet engraftment. Untransfused is defined as no transfusions within 7 days.|Up to Day 100|1 participant in control arm did not have a decrease in platelets and is not evaluable for this outcome measure.|||Participants|||Count of Participants
2605209|NCT02112045|Secondary|Number of Participants With Overall Response|"Overall response rate=CR+sCR+VGPR+PR~Complete response (CR), disappearance of monoclonal protein from the blood & urine and <5% plasma cells in bone marrow &disappearance of soft tissue plasmacytomas~Stringent complete response (sCR), CR & normal free light chain ratio & absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence~Very good partial response (VGPR), serum and urine monoclonal protein detectable by immunofixation but not on electrophoresis OR > 90% reduction in serum monoclonal protein with urine monoclonal protein < 100 mg per 24 hours and if present, > 50% reduction in the size of soft tissue plasmacytomas~Partial response (PR), > 50% reduction in the level of the serum monoclonal protein & reduction in urine monoclonal protein & > 50% reduction in the size of soft tissue plasmacytomas & if serum and urine monoclonal protein are unmeasurable and serum free light chain is unmeasurable, a > 50% reduction in plasma cells is required"|Up to 2 years||||Participants|||Count of Participants
2605210|NCT02112045|Secondary|Number of Participants With Adverse Events|-Assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|Up through Day 30||||Participants|||Count of Participants
2605211|NCT02112045|Primary|Number of Participants With Complete Response or Stringent Complete Response|"Complete response (CR) requires all of the following:~Disappearance of monoclonal protein by both protein electrophoresis and immunofixation studies from the blood and urine~<5% plasma cells in the bone marrow~Disappearance of soft tissue plasmacytomas~Stringent complete response (sCR) requires all of the following:~CR as defined above~Normal free light chain ratio~Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence"|Day +100||||Participants|||Count of Participants
2605212|NCT02111993|Secondary|Defibrillation Testing (DFT) Versus Upper Limit of Vulnerability (ULV) (Non-induced)|The DFT group was compared to the ULV subgroup that did not require ventricular fibrillation (VF) induction. Cardiac troponin (cTNT) levels were analyzed.|20 hours (hr)||||ng/mL||Standard Deviation|Mean
2605213|NCT02111993|Secondary|Defibrillation Testings (DFT) vs. Upper Limit of Vulnerability (ULV) (VF Induced)|the DFT group cardiac troponin (cTNT) values were compared to the subjects within the ULV group that required VF induction.|20 hours (hr)||||ng/mL||Standard Deviation|Mean
2605214|NCT02111993|Primary|Myocardial Damage|Myocardial damage will be evaluated by cardiac troponin (cTNT) lab collection before and then after ULV or DFT testing at 4 hours, 8 hours, and 20 hours.|20 hours (hr)||||ng/mL||Standard Deviation|Mean
2605215|NCT02111980|Primary|Capture Threshold Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure|Via device interrogation, capture threshold changes (the minimum amount of electricity that the box has to emit to pace the heart) were measured prior to and post RF Scanning with sponge. Multiple post-scan measurements were not taken for any participants presented here.|Baseline and 15 minutes|Because not all devices are equipped with RA, RV, and LV leads, note the population values in the below table for each group: right atrium (RA) thresholds, right ventricle (RV) thresholds, and left ventricle (LV) thresholds. The PTE participants were not included in this analysis because temporary devices do not have capabilities for interrogation.|||V||Standard Deviation|Median
2605216|NCT02111980|Primary|Changes in P & R Wave Measurements in Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure|The P and R waves were measured via device interrogation prior to and post RF scanning with sponge. Multiple post-scan measurements were not made for any of the participants represented here.|Baseline and 15 minutes|32 of the 40 participants were evaluated in this study for P and R measurements. 8 patients' devices either didn't have the P or R measured or they was unable to be measured. The PTE temporary pacing participants were not included in this analysis because temporary devices do not have capabilities for interrogation.|||mV||Standard Deviation|Median
2605217|NCT02111980|Primary|Shock Impedance Changes With Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure|The shock impedance changes were measured (right ventricle (RV) coil and superior vena cava (SVC) coil) prior to and post RF scanning with sponge. This was measured by performing a device interrogation in the electrophysiology (EP) lab. Multiple post-scan measurements were not taken for any of the patients presented here.|Baseline and 15 minutes|SVC and RV Coils are specific to ICDs, and therefore, PPMs and Temporary Pacemakers were not included in this analysis.|||ohms||Standard Deviation|Mean
2605218|NCT02111980|Primary|Pacing Impedance Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure|The impedance values of right ventricle (RV), right atrium (RA), and left ventricle (LV) leads was measured prior to RF scanning with sponge and post RF scanning with sponge. Multiple post-scan assessments were not made for any patient represented here.|Baseline and 15 minutes|40 subjects were analyzed. Note that not all had both RA, RV, and LV leads. Therefore, the number of leads (and therefore their impedance values reported below) does not match for each group. The PTE temporary pacing participants were not included in this analysis because temporary devices do not have capabilities for interrogation.|||ohms||Standard Deviation|Median
2605219|NCT02111980|Primary|Battery Capacity Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure|Of the patients enrolled, battery capacity changes were measured prior to and post RF scanning with sponge. Multiple post-scan assessments were not made for any of the patients presented here.|Baseline and 15 minutes|Of all participants, only 24 were analyzed in this outcome, as their devices reported battery life in millivolts (while other devices reported battery life in % or years). The PTE temporary pacing participants weren't included in this analysis because temporary devices do not have capabilities for interrogation.|||mV||Standard Deviation|Median
2605220|NCT02111980|Primary|Atrio-ventricular (AV) Delay Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure|The atrio-ventricular delay was measured prior to scanning with sponge and post RF scanning with sponge. Please note that multiple post-scan assessments were not made for any of the patients presented here.|Baseline and 15 minutes|31 patients were evaluated of the 40 in this analysis of the AV Delay 9 paced AV Delays were either not measured or unable to be measured during this study. The PTE participants were not included in this analysis because temporary devices do not have capabilities for interrogation (ie: recording AV Delay Changes).|||ms||Standard Deviation|Median
2605248|NCT02111746|Primary|Postoperative Pain as Assessed by a Five-point Satisfaction Scale|The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).|postoperative day 2|Intention-to-treat analysis. Data for this measure was collected for only 155 in the Exparel arm and 155 in the Regular Bupivacaine group.|||units on a scale||Standard Deviation|Mean
2605221|NCT02111980|Primary|Max Tracking Rate Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure|The max tracking rate on the CIEDs was measured prior to scanning with the sponge and post scanning with sponge. The max tracking rate is the maximum atrial rate at which a pacemaker will deliver a ventricular pacing stimulus following each sensed atrial beat. Below, the median and standard deviation are presented. Please note that multiple post-scan assessments were not made for any patient.|Baseline and 15 minutes|34 of 40 participants' Max Tracking Rate was measured. 6 MTRs were not measured or unable to be measured during testing. The PTE temporary pacing participants were not included in this analysis because temporary devices do not have capabilities for interrogation (ie: recording max tracking rate changes).|||bpm||Standard Deviation|Median
2605222|NCT02111980|Primary|Base Rate Measurement Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned w/ RF Assure|The base rate on patients' devices was measured before scanning with sponge and after RF scanning with sponge. The median was determined and is presented below with standard deviation for both times. Multiple post-scan assessments were not made.|Baseline and 15 minutes|The PTE temporary pacing participants were not included in this analysis because temporary devices do not have capabilities for interrogation (ie: recording base rate measurement changes).|||bpm||Standard Deviation|Median
2605223|NCT02111980|Primary|Pacing Polarity Changes With Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure|The patient's pacing polarity was measured prior to scanning with sponge and after scanning with sponge via device interrogation. The following pacing polarity measurements were evaluated: right atrium/right ventricle (RA/RV) bipolar polarity, left ventricle (LV) bipolar polarity, and left ventricle (LV) unipolar polarity. Note that not all study patients had LV leads implanted. Multiple post-scan assessments were not made.|Baseline and 15 minutes|The PTE participants were not included in this analysis because temporary devices do not have capabilities for interrogation (ie: recording pacing polarity changes).|||participants|||Number
2605224|NCT02111980|Primary|Pacing Mode Changes Between Permanent Pacemakers (PPMs)/Implantable Cardiac Defibrillators (ICDs) Scanned With RF Assure|The Pacing Mode on the CIED was measured prior to RF scanning (with sponge) and after the scanning (after sponge removal) in order to evaluate if any significant changes in the pacing mode setting resulted. The following CIED modes were evaluated: DDD (dual chamber pacing, sensing, triggered and inhibited mode), VVI (ventricular pacing, sensing, and inhibited mode), DDI (dual pacing, sensing, and inhibited mode), AAI (atrial pacing, sensing, and inhibited mode). The number of patients' device mode switched between these settings was tabulated and is shown in the below table. Multiple post-scan assessments were not made.|Baseline and 15 minutes|The PTE participants were not included in this analysis because temporary devices do not have capabilities for interrogation (ie: recording pacing mode changes).|||participants|||Number
2605225|NCT02111863|Secondary|Overall Survival (OS) of Patients Receiving a Lymphocyte Depleting Preparative Regimen|OS is defined as the time between the first day of treatment to the day of death or date last known alive.|up to 3 years||||months||Full Range|Median
2605226|NCT02111863|Primary|Objective Response Rate of Patients With Metastatic Melanoma|Objective response is defined as complete response + partial response and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|approximately 2 years||||percentage of participants|||Number
2605227|NCT02111863|Primary|Count of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|2 years and 59 days||||Participants|||Count of Participants
2605228|NCT02111811|Secondary|The Outcome is the Return on Investment (ROI) Obtained From Implementing the V-WHI Experimental Intervention.|"This variable is defined as: [marginal benefit on patient work productivity attributable to the V-WHI intervention] - [marginal cost of supplementing IC with V-WHI) / [marginal cost of supplementing IC with V-WHI]. The comparison assessed the monetized value of the difference in pre to post treatment changes in at-work productivity loss (presenteeism) + the monetized value of the difference in the changes in productivity loss due to work absences. Because both productivity loss components were measured at baseline and two follow-ups, the changes between time points (baseline to month 4 and month 4 to month 8/9) were first averaged before computing their difference.~The marginal costs attributable to V-WHI included the full costs of the providing the counseling treatment and supervision of the counselors."|9 months post randomization|The marginal costs attributable to V-WHI included the full costs of the providing the counseling treatment and supervision of the counselors. The ROI analysis did not evaluate costs other than the V-WHI costs, including standard care provided to both the IC only group and the IC+V-WHI group.|||marginal benefit in ($)|||Number
2605229|NCT02111811|Secondary|Sustained Improvement in Work Productivity|The outcome measure is the mean difference of the changes from baseline until about 9 months post randomization. The mean differences are then compared. The WLQ scale range=0-25 with higher scores indicating greater difficulty.|9 months post randomization|There were more subjects available at 9 months than at the end of the trial (4 months) as we attempted to contact all patients who had not withdrawn. We were able to reach a few at 9 months who were not available at 4.|||score on a scale||95% Confidence Interval|Mean
2605230|NCT02111811|Primary|Improvement in Work Related Disability Post Intervention|The outcome measure is the mean difference of the changes from baseline to time 1. The mean differences are then compared. The WLQ scale range=0-25 with higher scores indicating greater difficulty.|4 months post randomization||||units on a scale||95% Confidence Interval|Mean
2605231|NCT02111785|Other Pre-specified|Rate of Radiographic Resolution of Chronic Subdural Hematoma|The data were not collected.|6 months after diagnosis|||||||
2605232|NCT02111785|Secondary|Participants With a Markwalder Grading Score of 0|"Markwalder Grading Score (MGS)~The MGS is assessed as follows:~Grade 0 - Patient neurologically normal Grade 1 - Patient alert and oriented; mild symptoms, such as headache; absent or mild symptoms or neurologic deficit, such as reflex asymmetry Grade 2 - Patient drowsy or disoriented with variable neurological deficit, such as hemiparesis Grade 3 - Patient stuporous but responding appropriately to noxious stimuli; several focal signs, such as hemiparesis Grade 4 - Patient comatose with absent motor response to painful stimuli; decerebrate or decorticate posturing.~Higher scores mean a worse outcome."|6 months after hospital discharge||||Participants|||Count of Participants
2605233|NCT02111785|Secondary|Participants With a Glasgow Coma Scale Score of 15 at 6 Month Follow-up|Glasgow Coma Scale (GCS) The GCS is evaluated on a scale from 3 to 15, with higher scores indicating better outcome.|6 months after hospital discharge||||Participants|||Count of Participants
2605234|NCT02111785|Secondary|Participants With Modified Rankin Score 0, 1 or 2 at 6 Months|"The Modified Rankin Scale (mRS)~The mRS is evaluated as follows:~0 - No symptoms~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead.~Higher scores on the mRS scale mean a worse outcome."|6 months after hospital discharge||||Participants|||Count of Participants
2605235|NCT02111785|Secondary|Rate of Treatment Failure|This measure includes rate of repeat surgery in the burr hole group and rate of progression to surgery in the dexamethasone group|6 months after diagnosis|Reflects population analyzed for treatment failure. The one patient in the dexamethasone randomized group who died was not analyzed for this secondary outcome.|||Participants|||Count of Participants
2605236|NCT02111785|Primary|Number of Participants With a Modified Rankin Score of 0, 1 or 2|"The Modified Rankin Scale (mRS)~The mRS is evaluated as follows:~0 - No symptoms~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead.~Higher scores on the mRS scale mean a worse outcome."|6 months after diagnosis|Number of Participants with a modified Rankin Score of 0, 1 or 2.|||Participants|||Count of Participants
2605237|NCT02111772|Secondary|Airway Symptom Scores Experienced by Subjects During the 1st 4 Days of the Infection Evaluated Without Cough.|Symptom scores, including wheeze, shortness of breath, and chest discomfort were recorded by subjects twice daily. Each symptom was scored on a scale of 1-3. Therefore, the total maximum (worst) score for a day would be 18. The scores recorded daily could range from 0 to 18.|4 days|One asthmatic subject completed the study, but was dropped according to protocol because that subject acquired a cold after enrollment, but before rhinovirus inoculation. One subject without asthma was dropped according to protocol, because they did not develop a cold after inoculation with rhinovirus.|||units on a scale||95% Confidence Interval|Mean
2605238|NCT02111772|Primary|Airway Symptom Scores Experienced by Subjects During the 1st 4 Days of the Infection|The primary endpoint will be based on the comparison of cumulative lower respiratory tract symptom scores (CLRTS) in the asthmatic subjects compared to the non-asthmatic subjects over the first 4 days of acute infection. The symptoms evaluated daily included wheeze, chest tightness, shortness of breath, and cough. Symptom scores, including wheeze, shortness of breath, and chest discomfort were recorded by subjects twice daily. Each symptom was scored on a scale of 1-3. Therefore, the total maximum (worst) score for a day would be 24. The scores recorded daily could range from 0 to 24.|4 days|One asthmatic subject completed the study, but was dropped according to protocol because that subject acquired a cold after enrollment, but before rhinovirus inoculation. One subject without asthma was dropped according to protocol, because they did not develop a cold after inoculation with rhinovirus.|||units on a scale||95% Confidence Interval|Mean
2605239|NCT02111746|Secondary|Hospital Cost for Patient Care During Hospitalization|Hospital cost for patient care during hospitalization will be estimated from hospital charges and financial records.|duration of hospital stay, an expected average of 4 weeks|||||||
2605240|NCT02111746|Secondary|Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours||72 hours after surgery|||||||
2605241|NCT02111746|Secondary|Change From Baseline in Quality of Life|The impact of pain on patient's quality of life will be assessed through a brief pain inventory (BPI). In addition, the 5-point scale analgesia satisfaction survey will be used along with the BPI to assess patient satisfaction and quality of life.|Will be assessed preoperatively, on the first post-op day (POD 1), on POD2, and POD 3|||||||
2605242|NCT02111746|Secondary|Mean Length of Hospital Stay|Indirect outcome measure to assess the adequacy of postoperative pain control as an indicator of improvement in healing period, patient participation in physical therapy and faster patient mobilization, and overall health care cost|Participants will be followed for the duration of hospital stay, an expected average of 4 weeks|||||||
2605243|NCT02111746|Secondary|Overall Opioid Use|The total amount in mg of opioid medication consumed through 12, 24, 36, 48, 60, and 72 hours after surgery will be assessed.|Over the first 72 hours after surgery|||||||
2605244|NCT02111746|Primary|Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)|"The Brief Pain Inventory (BPI) ranges from 0 (no pain) to 10 (worst pain you can imagine)."|postoperative day 3|Intention-to-treat analysis. Data for this measure was collected for only 150 in the Exparel arm and 135 in the Regular Bupivacaine group.|||units on a scale||Standard Deviation|Mean
2605245|NCT02111746|Primary|Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)|"The Brief Pain Inventory (BPI) ranges from 0 (no pain) to 10 (worst pain you can imagine)."|postoperative day 2|Intention-to-treat analysis. Data for this measure was collected for only 151 in the Exparel arm and 149 in the Regular Bupivacaine group.|||units on a scale||Standard Deviation|Mean
2605274|NCT02111252|Secondary|Seroconversion Rate of SRH Antibody Titer|Seroconversion rate as measured by SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.|Day 22||||percentage of participants||95% Confidence Interval|Number
2605249|NCT02111746|Primary|Postoperative Pain as Assessed by a Five-point Satisfaction Scale|The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).|postoperative day 1|Intention-to-treat analysis. Data for this measure was collected for only 144 in the Exparel arm and 146 in the Regular Bupivacaine group.|||units on a scale||Standard Deviation|Mean
2605250|NCT02111746|Primary|Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)|"The Numeric Pain Scale (NPS) ranges from 0 (no pain) to 10 (worst possible pain)."|postoperative day 3|Intention-to-treat analysis. Data for this measure was collected for only 159 in the Exparel arm and 151 in the Regular Bupivacaine group.|||units on a scale||Standard Deviation|Mean
2605251|NCT02111746|Primary|Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)|"The Numeric Pain Scale (NPS) ranges from 0 (no pain) to 10 (worst possible pain)."|postoperative day 2|Intention-to-treat analysis. Data for this measure was collected for only 160 in the Exparel arm and 159 in the Regular Bupivacaine group.|||units on a scale||Standard Deviation|Mean
2605252|NCT02111746|Primary|Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)|"The Numeric Pain Scale (NPS) ranges from 0 (no pain) to 10 (worst possible pain)."|postoperative day 1|Intention-to-treat analysis. Data for this measure was collected for only 153 in the Exparel arm and 152 in the Regular Bupivacaine group.|||units on a scale||Standard Deviation|Mean
2605253|NCT02111603|Secondary|Concordance Correlation Coefficients of the Relative Composition of Stool Total and the Main Individual Bile Acids (BA)|"Stool 48 hour collections (for BAs) were collected during baseline before treatment, and then during days 9-10 of the 10 days of colesevelam dosing for fecal BAs. Relative composition of the main individual bile acids (cholic acid (CA), chenodeoxycholic acid (CDCA), deoxycholic acid (DCA), lithocholic acid (LCA) and ursodeoxycholic acid (UDCA)) in 48 hour stool collection after colesevelam treatment were compared to baseline values.~The concordance correlation coefficient (rc) measures agreement between two variables. The concordance correlation satisfies -1 ≤ rc ≤ +1. A value of rc = +1 corresponds to perfect agreement. A value of rc = -1 corresponds to perfect negative agreement, and a value of rc = 0 corresponds to no agreement."|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.|||concordance correlation coefficient||Standard Error|Mean
2605254|NCT02111603|Secondary|Change in Stool Frequency (Number of Stools Per Week)|Change in stool frequency from baseline in response to treatment with colesevelam.|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.|||Number of stools per week||Standard Error|Mean
2605255|NCT02111603|Secondary|Change in Stool Consistency|"The subjects rated their stool consistency using the Bristol Stool Form Scale. The Bristol Stool Form Scale is a medical aid designed to classify the form of human feces into seven categories or types. Types 1 and 2 indicate constipation with 3 and 4 being the ideal stools especially the latter, as they are the easiest to defecate, and 5-7 tending towards diarrhea."|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.|||units on a scale||Standard Error|Mean
2605256|NCT02111603|Secondary|Change in Fecal Fat Excretion|Change in fecal fat excretion from baseline in response to treatment with colesevelam|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.|||g/day||Standard Error|Mean
2605257|NCT02111603|Secondary|Change in Fasting Serum C4|Change in fasting serum C4 from baseline in response to treatment with colesevelam.|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.|||ng/mL||Standard Error|Mean
2605258|NCT02111603|Primary|Change in Total 48 Hour Fecal Bile Acids (BA) From Baseline in Response to Treatment With Colesevelam|Stool 48 hour collections (for BAs) were collected during baseline before treatment, and then during days 9-10 of the 10 days of colesevelam dosing for fecal BAs. Total fecal BA were measured using HPLC/tandem mass spectrometry.|baseline, 10 days|13 subjects were accrued. One subject withdrew from the study after the pre-drug activities, but before the treatment activities. Only the 12 participants with complete data at both baseline and after 10 days of treatment are included in the Outcome Measure.|||uM||Standard Error|Mean
2605259|NCT02111564|Secondary|Event Rate Based on Time From Randomization to First Occurrence of All-Cause Mortality (ACM) Adjudicated by CEC|Event rate based on time from randomization to first occurrence of ACM (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.|Up to Day 45|ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.|||Events per 100 participants in 45 days|||Number
2605260|NCT02111564|Secondary|Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE, Myocardial Infarction (MI), Non-Hemorrhagic Stroke, and Cardiovascular (CV) Death Adjudicated by CEC|Event rate based on time from randomization to the first occurrence of a composite of symptomatic VTE (lower extremity DVT and non-fatal PE), MI, non-hemorrhagic stroke, and CV death (death due to a known CV cause and death in which a CV cause cannot be ruled out; by this definition, a VTE-related death was considered a CV death) as adjudicated by CEC was reported. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.|Up to Day 45|ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.|||Events per 100 participants in 45 days|||Number
2605275|NCT02111252|Secondary|Seroprotection Rate of SRH Antibody Titer|Seroprotection rate is measured by SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.|Day 22|The full analysis set was used.|||percentage of participants||95% Confidence Interval|Number
2605261|NCT02111564|Secondary|Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE and All-Cause Mortality (ACM) Adjudicated by CEC|Event rate based on time from randomization to the first occurrence of a composite of symptomatic VTE and ACM (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.|Up to Day 45|ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.|||Events per 100 participants in 45 days|||Number
2605262|NCT02111564|Secondary|Event Rate Based on Time From Randomization to the First Occurrence of a Symptomatic Venous Thromboembolism Event (VTE) Adjudicated by CEC|Event rate based on time from randomization to the first occurrence of a symptomatic VTE (adjudicated by CEC) was assessed. Symptomatic VTE included lower extremity DVT and non-fatal PE. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.|Up to Day 45|ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.|||Events per 100 participants in 45 days|||Number
2605263|NCT02111564|Secondary|Event Rate Based on Time From Randomization to First Occurrence of VTE-Related Death Adjudicated by CEC|Event rate based on time from randomization to first occurrence of VTE-related death (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.|Up to Day 45|ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.|||Events per 100 participants in 45 days|||Number
2605264|NCT02111564|Primary|Event Rate Based on Time From Randomization to the First Occurrence of Major Bleeding Adjudicated by CEC|A major bleeding event was defined using validated International Society on Thrombosis and Haemostasis (ISTH) bleeding criteria. A major bleeding event was defined as overt bleeding that was associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or a critical site defined as intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or a fatal outcome. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or last dose + 2 days.|From randomization to 2 days after the last dose (Day 45)|The Safety analysis set included all enrolled participants in the ITT analysis set who received at least 1 dose of study drug.|||Events per 100 participants in 45 days|||Number
2605265|NCT02111564|Primary|Time From Randomization to First Occurrence of Composite of All Symptomatic Venous Thromboembolism (VTE) and VTE Related Death Adjudicated by Clinical Event Committee (CEC)|Symptomatic VTE included lower extremity deep vein thrombosis (DVT) and non-fatal pulmonary embolism (PE). Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.|Up to Day 45|Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.|||Events per 100 participants in 45 days|||Number
2605266|NCT02111447|Secondary|Incidence of Airway Complications|All airway reflex responses including airway obstruction breath holding, coughing, laryngospasm, desaturation <92% for >15 s regardless of the cause, bronchospasm, secretions and hiccups|WIthin 2 hours of emergence from anesthesia|none recruited to that group|||Participants|||Count of Participants
2605267|NCT02111447|Primary|Incidence of Delirium on Emergence|Delirium on emergence will be assessed using the PAED scale by a blinded observer in the post anesthesia period. A score >12 constitutes a diagnosis of delirium in children. The post anesthesia period is usually <2 hours after anesthesia.|WIthin 2 hours of emergence from anesthesia|none recruited that that group|||Participants|||Count of Participants
2605268|NCT02111369|Primary|Change in Acoustic Spectrograms|"Objective Voice Assessment~• Using the Computerized Speech Laboratory speech and voice analysis system (KayPENTAX, Montvale, NJ)"|baseline, 2 weeks, 6 weeks|Data were not collected as investigators found the Voice Related Quality of Life (VRQOL) scale to be a better measure.||||||
2605269|NCT02111369|Primary|Change in Global Voice Rating|"Patient-Reported Measure~• 0-7 ranking"|Baseline, 2 weeks, 6 weeks|Data were not collected as investigators found the Voice Related Quality of Life (VRQOL) scale to be a better measure.||||||
2605270|NCT02111369|Primary|Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score|"The CAPE-V is a clinically validated perceptual voice assessment tool that is used to describe the severity of auditory-perceptual attributes of a voice problem, in a way that can be communicated among clinicians. Participant's speech is recorded and evaluated by trained listeners. Listeners indicate overall tremor severity by making a tick mark on a 1 to 100 mm visual analog scale. Total scores range from 0 to 100 where 0 is the best score and 100 is the worst score."|Baseline, 2 weeks, 6 weeks|Participants who completed all three study visits (Baseline Visit 1, Visit 2, and Visit 3).|||units on a scale||Standard Deviation|Mean
2605271|NCT02111369|Primary|Change in Voice-Related Quality Of Life (VRQOL) Questionnaire Score|"The VRQOL is a ten question self-reported measure that asks patients to rate responses from 1-5 (1=none, not a problem, 2=a small amount, 3=a moderate (medium) amount, 4=a lot, 5=problem is as bad as it can be). Total scores range from 0 to 100. A higher score indicates more problems interfering with day to day activities."|Baseline, 2 weeks, 6 weeks|Participants who completed all three study visits (Baseline Visit 1, Visit 2, and Visit 3).|||units on a scale||Standard Deviation|Mean
2605272|NCT02111369|Primary|Change in Quality of Life in Essential Tremor (QUEST) Questionnaire Score|The QUEST questionnaire is a 30 item self-reported essential tremor-specific quality of life scale that asks participants to rate responses (never/no, rarely, sometimes, frequently, always/yes, or not applicable). Total scores range between 0 to 100 where 0 is the best score and 100 is the worst score. A higher score indicates a lower quality of life.|Baseline, 2 weeks, 6 weeks|Participants who completed all three study visits (Baseline Visit 1, Visit 2, and Visit 3).|||units on a scale||Standard Deviation|Mean
2605273|NCT02111252|Secondary|Geometric Mean Fold Increase in SRH Antibody Titer|Geometric mean fold increase in SRH antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared to baseline.|Day 22||||Fold Change||95% Confidence Interval|Geometric Mean
2605278|NCT02111252|Secondary|Change From Baseline in Safety Electrocardiogram (ECG) Parameters|The ECG data will be analyzed into 3 categories, `normal`, `abnormal but not clinically significant` and `abnormal clinically significant`. Using these variables, shift tables (before and after vaccination) will be created by individual participant. . The definitions for the acronyms are as follows: Within Normal Limits (WNL), Not Clinically Significant (NCS), and Clinically Significant (CS).|Day 1 and Day 22||||participants|||Number
2605279|NCT02111252|Secondary|Change From Baseline in Blood Pressure|For continuous variables, summary statistics of measured values and respective changes from baseline will be calculated at each evaluation time point. In addition, figures illustrating individual changes will be created. For discrete variables, shift tables (before and after vaccination) will be created.|Day 1 (Baseline), Day 8, Day 22||||mmHg||Standard Deviation|Mean
2605280|NCT02111252|Primary|Geometric Mean Fold Increase in HI Antibody Titer|Geometric mean fold increase in HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared to baseline.|Day 22|The full analysis set was used.|||Fold Change||95% Confidence Interval|Geometric Mean
2605281|NCT02111252|Primary|Seroconversion Rate of HI AntibodyTiter|Seroconversion rate is measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion Rate was defined as the perccentage of participants with a baseline HI antibody titer of ≥ 10 achieving a minimal 4-fold increase, or baseline HI antibody titer of < 10 achieving an HI antibody titer of ≥ 40 for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 22||||Percentage of participants||95% Confidence Interval|Number
2605282|NCT02111252|Primary|Percentage of Participants With Seroprotection Rate of Hemagglutination Inhibition [HI] Antibody Titer|Seroprotection rate is measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroprotection Rate was defined as the percentage of participants with HI antibody titer ≥ 40 for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).|Day 22|The full analysis set was used.|||Percentage of participants||95% Confidence Interval|Number
2605283|NCT02111252|Primary|Number of Participants With Solicited Injection Site and Systemic Adverse Events|Number of participants with injection site and systemic adverse events will be tabulated in its own, and by severity and day of onset. Described if solicited adverse event term is different from the PT.|For 22 days|The safety analysis set, comprised the volunteers who received a single dose of 0.5 mL TAK-850, was used.|||participants|||Number
2605284|NCT02111213|Secondary|Change in Moderate to Vigorous Physical Activity From Baseline to 12 Months|moderate to vigorous intensity physical activity as measured by self-report questionnaire|baseline, 12 months|||||||
2605285|NCT02111213|Secondary|Change in Sedentary Behavior From Baseline to 12 Months|Self-reported time spent in the following activities: watching television, computer use, reading, socializing, transport and hobbies, and a summary measure (total sedentary time).|baseline, 12 months||2020-03-31|03/2020||||
2605286|NCT02111213|Primary|Change in Total Weekly Walking Minutes From Baseline to 12 Months|Total weekly walking minutes as measured by self-report (CHAMPS Physical Activity Questionnaire)|baseline, 12 months|12-month Change in total minutes per week Per protocol|||minutes per week||Standard Error|Mean
2605287|NCT02111200|Primary|Total Nitrogen as a Conjugate of the Drug|The objective of this protocol is to directly compare the efficacy of benzoate, phenylbutyrate and a combination of the two, to conjugate nitrogenous compounds in healthy volunteers. The nitrogenous compound of interest in each arm would be based on the medication used. This would be hippuric acid in the benzoate arm, phenylacetylglutamine in the phenylbutyrate arm, and hippuric acid AND phenylacetylglutamine in the MIX arm.|4 days per arm||||mmol/24 hours||Standard Deviation|Mean
2605288|NCT02111200|Primary|Urinary PAGN Excretion|The objective of this protocol is to directly compare the efficacy of benzoate, phenylbutyrate and a combination of the two, to conjugate nitrogenous compounds in healthy volunteers. The nitrogenous compound of interest in each arm would be based on the medication used. This would be hippuric acid in the benzoate arm, phenylacetylglutamine in the phenylbutyrate arm, and hippuric acid AND phenylacetylglutamine in the MIX arm. The mean phenylacetylglutamine levels in the benzoate arm would thus be 0.|4 days per arm||||mmol/24 hours||Standard Deviation|Mean
2605289|NCT02111200|Primary|Urinary Hippuric Acid|The objective of this protocol is to directly compare the efficacy of benzoate, phenylbutyrate and a combination of the two, to conjugate nitrogenous compounds in healthy volunteers. The nitrogenous compound of interest in each arm would be based on the medication used. This would be hippuric acid in the benzoate arm, phenylacetylglutamine in the phenylbutyrate arm, and hippuric acid AND phenylacetylglutamine in the MIX arm. The mean hippuric acid levels in the phenylbutyrate arm would thus be 0.|4 days per arm||||mmol/24 hours||Standard Deviation|Mean
2605290|NCT02111187|Secondary|Number of Participants With Adverse Events in Each Group (LDE225 and Observation)|Safety and tolerability, including any drug-related toxicities of Sonidegib, were reported via CTCAE version 4.0.|Up to 3 years||||Participants|||Count of Participants
2605291|NCT02111187|Secondary|Effect of LDE225 on PSA Recurrence Following Prostatectomy|To evaluate whether presurgical treatment with LDE225 diminishes the risk of PSA recurrence following prostatectomy.|Up to 3 years||||ng/ml||Full Range|Median
2605292|NCT02111187|Secondary|Percentage of Participants With a Pathological Effect of Presurgical Treatment With LDE225|To determine whether presurgical treatment with LDE225 can exert a pathological effect on high-risk tumors (i.e. increase apoptosis, decrease proliferation).|Up to 3 years||||Participants|||Count of Participants
2605293|NCT02111187|Primary|Change From Baseline in Tissue Gli1 Expression Levels Using qRT-PCR Analysis in Each Group (LDE225 and Observation)|This was defined as the number of patients who achieved at least a two-fold reduction in GLI1 expression in post-treatment vs. pre-treatment tumor tissues.|Up to 3 Years||||Participants|||Count of Participants
2605294|NCT02111174|Secondary|Number of Patients Who Stopped Using Neuroleptics at 28 Days|This will be assessed by concomitant medication review by a study team member during the 10 days of treatment. Follow-up was assessed as participant self-report over the last 10 days; all opiates were further tabulated using a morphine oral dose equivalents table to allow better comparison between patients and arms.|28 days post-intervention|Data was analyzed from 17/18 participants in Arm 1 since one was deemed ineligible in retrospect.|||Participants|||Count of Participants
2605679|NCT02107339|Secondary|Hydromorphone Use Second 24 Hours||24-48 hours after surgery||||milligrams||Inter-Quartile Range|Median
2605295|NCT02111174|Secondary|Number of Patients Who Stopped Using Opioids at 28 Days|This will be assessed by concomitant medication review by a study team member during the 10 days of treatment. Follow-up was assessed as participant self-report over the last 10 days; all opiates were further tabulated using a morphine oral dose equivalents table to allow better comparison between patients and arms.|28 days post-intervention|Data was analyzed from 17/18 participants in Arm 1 since one was deemed ineligible in retrospect.|||Participants|||Count of Participants
2605296|NCT02111174|Secondary|Changes in Patient Reported Motor Outcomes at 3 Months|This will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For motor there are 8 questions with a total score range from 0-24 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.|Change from baseline to 3 months||||units on a scale||Standard Deviation|Mean
2605297|NCT02111174|Secondary|Changes in Patient Reported Motor Outcomes at 2 Months|This will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For motor there are 8 questions with a total score range from 0-24 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.|Change from baseline to 2 months||||units on a scale||Standard Deviation|Mean
2605298|NCT02111174|Secondary|Changes in Patient Reported Motor Outcomes at 28 Days|This will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For motor there are 8 questions with a total score range from 0-24 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.|Change from baseline to 28 days|Data was analyzed from 17/18 participants in Arm 1 since one was deemed ineligible in retrospect.|||units on a scale||Standard Deviation|Mean
2605299|NCT02111174|Secondary|Changes in Patient Reported Sensory Outcomes at 3 Months|This was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For sensory there are 9 questions with a total score range from 0-27 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.|Change from baseline to 3 months||||units on a scale||Standard Deviation|Mean
2605300|NCT02111174|Secondary|Changes in Patient Reported Sensory Outcomes at 2 Months|This was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For sensory there are 9 questions with a total score range from 0-27 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.|Change from baseline to 2 months||||units on a scale||Standard Deviation|Mean
2605301|NCT02111174|Secondary|Changes in Patient Reported Sensory Outcomes at 28 Days|This was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CIPN20, a CIPN-specific questionnaire which includes two scales assessing sensory and motor symptoms and functioning with each question measured on a 0-3 scale. For sensory there are 9 questions with a total score range from 0-27 with higher scores indicating more bothersome symptoms. A negative change in score indicates improvement in symptoms.|Change from baseline to 28 days|Data was analyzed from 17/18 participants in Arm 1 since one was deemed ineligible in retrospect.|||units on a scale||Standard Deviation|Mean
2605302|NCT02111174|Secondary|Change in Pain at 3 Months as Measured by the Modified Brief Pain Index|To determine the change in pain from day 0 to 3 months (as measured by the Modified Brief Pain Index (BPI), question #3) with scrambler therapy in patients with chemotherapy induced peripheral neuropathy and pain (CIPN). The BPI short form is a pain assessment tool used with cancer patients to measure both severity of pain and interference caused by pain on 0-10 scales with higher scores indicating more pain. A negative score for the change in pain indicates improvement.|Change from baseline to 3 months||||units on a scale||Standard Deviation|Mean
2605303|NCT02111174|Secondary|Change in Pain at 2 Months as Measured by the Modified Brief Pain Index|To determine the change in pain from day 0 to 2 months (as measured by the Modified Brief Pain Index (BPI), question #3) with scrambler therapy in patients with chemotherapy induced peripheral neuropathy and pain (CIPN). The BPI short form is a pain assessment tool used with cancer patients to measure both severity of pain and interference caused by pain on 0-10 scales with higher scores indicating more pain. A negative score for the change in pain indicates improvement.|Change from baseline to 2 months||||units on a scale||Standard Deviation|Mean
2605304|NCT02111174|Primary|Change in Pain as Measured by the Modified Brief Pain Index at 28 Days|To determine the change in pain from day 0 to day 28 (as measured by the Modified Brief Pain Index (BPI), question #3) with scrambler therapy in patients with chemotherapy induced peripheral neuropathy and pain (CIPN). The BPI short form is a pain assessment tool used with cancer patients to measure both severity of pain and interference caused by pain on 0-10 scales with higher scores indicating more pain. A negative score for the change in pain indicates improvement.|Change from baseline to 28 days|Data was analyzed from 17/18 participants in Arm 1 since one was deemed ineligible in retrospect.|||units on a scale||Standard Deviation|Mean
2605305|NCT02111096|Secondary|Number of Participants With Hypoglycemic Events|Documented symptomatic hypoglycemia, an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <=70 mg/dL (<=39 mmol/L), is presented. The number of subjects with an event are subjects who had at least one episode of documented symptomatic hypoglycemia during the time period.|Baseline through 6 months|All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point, excluding data collected after study drug and/or starting rescue therapy.|||Participants|||Count of Participants
2605334|NCT02110706|Primary|Steroid Sparing Effect|Percent of subjects that achieve a ≥ 75% reduction in mean daily prednisone dose in the 4 weeks prior to week 52 and have clinical improvement or no significant worsening of symptoms (≤ 2 point increase in MGC score) as compared to 4-week period prior to randomization and initiation of treatment.|4 weeks prior baseline and 4 weeks prior to week 52|Intention to treat participants|||Participants|||Count of Participants
2605306|NCT02111096|Secondary|Rate of Hypoglycemic Events Adjusted Per 30 Days|Documented symptomatic hypoglycemia, an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <=70 mg/dL (<=39 mmol/L),is presented. Rate: (30 days) is calculated as: (number of episodes during the time period divided by the number of days during the time period) multiplied by 30.|Baseline through 6 months|All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point, excluding data collected after stopping study drug and/or starting rescue therapy.|||number of episodes per day|||Number
2605307|NCT02111096|Secondary|Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021||Day 1 Month 1, 3, 6, 9, predose, 1 hour postdose,|All participants who received at least 1 dose of study drug and had evaluable PK data.|||Liters (L)||95% Confidence Interval|Number
2605308|NCT02111096|Secondary|Population Pharmacokinetics: Apparent Clearance of LY2409021|Reported as a Population Estimate with % Standard Errors of Estimation (SEE), 5th-95th confidence interval.|Day 1 Month 1, 3, 6, 9, predose, 1 hour postdose,|All randomized participants who received at least 1 dose of study drug and had evaluable PK data.|||Liters per hour (L/h)||95% Confidence Interval|Number
2605309|NCT02111096|Secondary|Change From Baseline to 6 Months in 7-Point Self-Monitoring of Blood Glucose (SMBG)|7-point profile consists of pre-meal and 2-hour postprandial SMBG measurements for the morning, midday, and evening meals in 1 day and at 3 AM (nocturnal blood glucose measurement). Pre-meal measurements were taken before the subject began eating the meal. Participants recorded their glucose measurements in their study diaries.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point, excluding data collected after stopping study drug and/or starting rescue therapy.|||mg/dL||Standard Deviation|Mean
2605310|NCT02111096|Secondary|Change From Baseline to 6 Months in Pulse Rate|Seated pulse rate was measured in triplicate throughout the study. At each visit, all available pulse measurements for a subject were averaged to provide the pulse for that visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point.|||beats per minutes (bpm)||95% Confidence Interval|Least Squares Mean
2605311|NCT02111096|Secondary|Change From Baseline to 6 Months in Blood Pressure|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured in triplicate throughout the study. At each visit, all available blood pressure measurements for a subject were averaged to provide the blood pressure for that visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point.|||millimeters of mercury (mm/Hg)||95% Confidence Interval|Least Squares Mean
2605312|NCT02111096|Secondary|Change From Baseline to 6 Months in Fasting Plasma Glucose|Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug,have data at baseline and at least 1 post-baseline time point, excluding data collected after stopping study drug and/or starting rescue therapy.|||milligram per decililiter (mg/dL)||95% Confidence Interval|Least Squares Mean
2605313|NCT02111096|Secondary|Change From Baseline to 6 Months in Hemoglobin A1c (HbA1c)|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, visit, baseline score, and treatment-by-visit.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point, excluding data collected after stopping study drug and/or starting rescue therapy.|||percent of HbA1c||95% Confidence Interval|Least Squares Mean
2605314|NCT02111096|Secondary|Change From Baseline to 6 Months in Body Weight|Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point.|||kilograms (kg)||90% Confidence Interval|Least Squares Mean
2605315|NCT02111096|Secondary|Change From Baseline to 6 Months in Fasting Blood Glucagon|Glucagon values assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug, have data at baseline and at least 1 post-baseline time point.|||picomol per liter (pmol/L)||95% Confidence Interval|Least Squares Mean
2605316|NCT02111096|Secondary|Change From Baseline to 6 Months in Fasting Lipids Levels|Lipid values (cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides) assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.|Baseline, 6 months|All randomized participants who received at least 1 dose of randomized study drug, have data at baseline and at least 1 post-baseline time point.|||millimol per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2605317|NCT02111096|Secondary|Number of Participants With Hepatobiliary Adverse Events of Special Interest (AESI)|Number of participants with ALT or AST greater than 3 times the upper limit of normal at a post-baseline visit. A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2605335|NCT02110693|Secondary|Cannabis Positive Oral Fluid Test|Positive Oral Fluid Cannabis testing.|baseline|Adult Primary Care Patients with oral fluid test results|||Spearman Correlation|||Number
2605336|NCT02110693|Secondary|Smokeless Tobacco Questionnaire|Any yes response to smokeless tobacco use reported on the smokeless tobacco questionnaire is considered high risk.|baseline|Adult Primary Care patients|||Spearman Correlation||95% Confidence Interval|Number
2605318|NCT02111096|Secondary|Change From Baseline to 6 Months in Alanine Aminotransferase Levels|Alanine aminotransferase (ALT) assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug, baseline data and at least 1 post-baseline time point.|||microgram per Liter (µ/L)||95% Confidence Interval|Least Squares Mean
2605319|NCT02111096|Primary|Change From Baseline to 6 Months in Hepatic Fat Fraction|The hepatic fat fraction (HFF) was calculated by a core imaging laboratory from noncontrast magnetic resonance imaging (MRI) of the liver. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.|Baseline, 6 months|All randomized participants who received at least 1 dose of study drug, have usable MRI HFF data at baseline and at least 1 post-baseline time point, excluding any data collected after stopping study drug.|||percentage||95% Confidence Interval|Least Squares Mean
2605320|NCT02111083|Primary|Pharmacokinetic Parameter: Area Under the Curve(AUC)||Zero to infinity [AUC(0-∞)]|All participants who had at least one study treatment and had evaluable PK data.|||picomole*hour/liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2605321|NCT02111083|Secondary|Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax)||Day 1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable PD data.|||hours||Geometric Coefficient of Variation|Geometric Mean
2605322|NCT02111083|Secondary|Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax)|The maximum observed glucose infusion rate during the euglycemic clamp procedure.|Day 1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable PD data.|||milligrams per minute (mg/min)||Geometric Coefficient of Variation|Geometric Mean
2605323|NCT02111083|Secondary|Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot)|The total amount of glucose infused during the euglycemic clamp procedure.|Day1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable pharmacodynamic(PD) data.|||grams (g)||Geometric Coefficient of Variation|Geometric Mean
2605324|NCT02111083|Secondary|Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax)||Day 1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable PK data.|||hours||Full Range|Median
2605325|NCT02111083|Primary|Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax)||Day 1, predose through 8 hours post dose in each period|All participants who had at least one study treatment and had evaluable PK data.|||picomole/liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
2605326|NCT02111083|Primary|Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast)||Day 1, predose through 8 hours post dose in each period.|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||picomole*hour/liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2605327|NCT02110901|Other Pre-specified|Number of Participants With Unassisted AVF Use for Hemodialysis|Unassisted AVF use for hemodialysis is defined as continuous use of the AVF for hemodialysis without prior primary unassisted patency loss. Use of the AVF for hemodialysis is defined as the ability of the study AVF to be successfully cannulated and used for hemodialysis for a minimum of 90 days or at least 30 days prior to a patient's last visit, if hemodialysis was not initiated at least 90 days prior to the last visit. Non-use of the AVF for hemodialysis is defined as an abandoned fistula prior to use; or if hemodialysis is recorded on 2 consecutive visits and there is no cannulation date or duration of use is less than 90 days. The patients who are not categorized as having use or non-use of the AVF by the rules described above have insufficient data to determine use for hemodialysis and will be categorized as having indeterminate use.|Assessed at 12 months|Patients with unassisted use or non-use of their AVF for hemodialysis. Patients with indeterminate use of their AVF were excluded.|||Participants|||Count of Participants
2605328|NCT02110901|Other Pre-specified|Number of Participants With Unassisted AVF Maturation by Ultrasound|AVF maturation is defined as average cephalic vein lumen diameter >= 4 mm and an outflow vein volume blood flow >= 500 mL/min by ultrasound without prior primary unassisted patency loss.|Assessed 3 months after AVF creation|Full analysis set includes any patient who was randomized|||Participants|||Count of Participants
2605329|NCT02110901|Primary|Kaplan-Meier Estimate of Secondary AVF Patency|Kaplan-Meier Estimate of median time from AVF creation until AVF abandonment (secondary patency)|Median time from AVF creation until AVF abandonment (secondary patency), assessed up to 1 year|Full analysis set included all patients who were randomized|||days||95% Confidence Interval|Median
2605330|NCT02110901|Primary|Time to AVF Primary Unassisted Patency|Primary unassisted patency defined as the time from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency.|Days from AVF creation until the first occurrence of either access thrombosis or procedure to restore or maintain patency, assessed up to 1 year|Full analysis set includes any patient who was randomized.|||Days||95% Confidence Interval|Median
2605331|NCT02110706|Secondary|Change in Quantitative Myasthenia Gravis(QMG) Scores From Baseline to Week 52|Evaluate whether there is a trend towards clinical benefit at end of 52 week treatment period, as measured by the mean change in the QMG score - a specific clinical outcome scale used as endpoint in prior MG clinical trials. The Quantitative Myasthenia Gravis Score (QMG) is a commonly used objective outcome measure in myasthenia gravis (MG) comprising 13 items, each with a possible score from 0 to 3, and a maximum possible of 39 points, where a higher score indicates more severe disease.|baseline and 52 weeks|Intention to treat participants|||score on a scale||Standard Deviation|Mean
2605332|NCT02110706|Secondary|Change in Myasthenia Gravis Composite (MGC) Scores From Baseline to Week 52|Evaluate whether there is a trend towards clinical benefit at end of 52 week treatment period, as measured by mean change in the MGC score, an MG-specific clinical outcomes scale used as endpoint in prior MG clinical trials. The Myasthenia Gravis Composite (MGC) scale consists of test items from the MG-ADL (Myasthenia Gravis Activities of Daily Living) scale and the QMG (Quantitative Myasthenia Gravis Scale) that measure symptoms and signs of MG, with weighted response options. The minimum score is 0, and the maximum score is 50. Higher scores correlate with clinical worsening of the disease.|baseline and 52 weeks|Intention to treat participants|||score on a scale||Standard Deviation|Mean
2605338|NCT02110693|Secondary|Risky Alcohol Use|Measured by the Alcohol Use Disorders Identification Test - Consumption Items. High risk on the AUDIT-C is 10 or higher. The higher the score on the AUDIT-C the greater the alcohol problem.The range of scores on the AUDIT-C is from 0 (no problem) to 12 (maximum problem).|Baseline|Adult Primary Care Patients|||Spearman Correlation||95% Confidence Interval|Number
2605339|NCT02110693|Secondary|Unhealthy Cannabis Use|The Time Line Follow Back Interview measures participant's self-reported number of days of cannabis use in the 30 days prior to the interview. Unhealthy cannabis use is considered 1 or more days of cannabis use in the past 30 days.The reported data represent the correlation between the TAPS Tool Cannabis Score and the Number of Days of cannabis use|Baseline||||Spearman Correlation||95% Confidence Interval|Number
2605340|NCT02110693|Secondary|High Risk Tobacco Use Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)|The ASSIST assess lifetime and past 3 month substance use. A score on the Tobacco Scale from 0-3 is low risk, 4-26 is medium risk, and 27 or greater is high risk.The scales range is from 0 (no problem) to 31 (most severe problem).|Baseline|Adult primary care patients|||Sensitivity||95% Confidence Interval|Number
2605341|NCT02110693|Primary|Diagnostic and Statistical Manual DSM-5 Diagnosis of Tobacco Use Disorder Measured by the Modified World Mental Health Composite International Diagnostic Interview|The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria|Baseline|adult primary care patients|||Sensivity||95% Confidence Interval|Number
2605342|NCT02110693|Primary|Diagnostic and Statistical Manual DSM-5 Diagnosis of Heroin Use Disorder Measured by the The Modified World Mental Health Composite International Diagnostic Interview|The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria|Baseline|Adult primary care patients|||Sensitivity||95% Confidence Interval|Number
2605343|NCT02110693|Primary|Diagnostic and Statistical Manual-5 (DSM-5) Cocaine and Amphetamine (Stimulant) Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview|The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria|Baseline|Adult primary care patients|||Sensitivity||95% Confidence Interval|Number
2605344|NCT02110693|Primary|Diagnostic and Statistical Manual-5 (DSM-5) Cannabis Use Disorder Diagnosis Measured With Modified World Mental Health Composite International Diagnostic Interview|The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria|Baseline|Adult primary care population|||Sensitivity||95% Confidence Interval|Number
2605345|NCT02110693|Primary|Diagnostic and Statistical Manual-5 (DSM-5) Alcohol Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview|The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria|Baseline|Adult primary care patients|||Sensitivity||95% Confidence Interval|Number
2605346|NCT02110485|Secondary|PedsQL Pediatric Quality of Life Inventory and PedsQL Family Impact Module Scales|"The PedsQL Pediatric Quality of Life Inventory is a 23 item survey with response options offered on a 5 point scale; 0= never been a problem; 1=almost never a problem; 2=sometimes a problem; 3=often a problem; 4=almost always a problem. A total score is summed for each of the 4 dimensions as well as an overall score for the entire measure.~The PedsQL Family Impact Module Scales include subscales: physical functioning; emotional functioning; social functioning; cognitive functioning; communication; worry; family functioning; daily activities; and family relationships. The options for this 5-point scale range from 0= never a problem to 4=always a problem). Items are reverse-scored and high scores indicate better family functioning. A total summed score is utilized. Each subscale can be summed individually and divided by the number of items in that.~Total scores for this measure range from 0-92"|30 day follow-up||||units on a scale||Inter-Quartile Range|Median
2605347|NCT02110485|Secondary|Number of Participants Readmitted|Readmissions rates to any hospital within 1 year wil be assessed|1 year||||Participants|||Count of Participants
2605348|NCT02110485|Secondary|Patient Activation Measure (PAM)|"Parent activation will be assessed with the Patient Activation Measure® (Parent-PAM®) using a version of healthy child parent PAM® adapted with permission. This 13 item scale and was derived from the short form version of the Patient Activation Measure®. The Parent-PAM® is used to assess the parent's activation in the management of their child's health.~The 13 items have response options ranging from 1=strongly disagree to 4 strongly agree with an option to respond as not applicable. A total PAM score is calculated by summing all items and dividing by the number of items answered and multiplied by 13; total scores can range from 13-52. This score is transformed to a scale ranging from 0-100 with higher PAM scores indicating higher patient activation."|1 hour||||units on a scale||Inter-Quartile Range|Median
2605349|NCT02110485|Primary|Disability Days|Disability days will be assessed at 1 year follow-up. Disability days is a composite of inpatient hospital days, emergency department visits, primary care physician visits and all days with limited activities referable to their appendicitis.|1 year folow-up||||Days||Inter-Quartile Range|Median
2605350|NCT02110485|Primary|PedsQL 3.0 Healthcare Satisfaction Generic Module (Parent Report)|"Healthcare satisfaction will be measured at the time of discharge (average 1-2 days) using the PedsQL 3.0 Healthcare Satisfaction Generic Module- Parent Report. This survey measures the parent's satisfaction with the care their child received and measures six dimensions (information, inclusion of family, communication, technical skills, emotional needs, and overall satisfaction) using 24 items. Parents chose a score from 0-4; 0=never happy; 1=sometimes happy; 2=often happy; 3=almost always happy; 4=always happy, followed by the ability to respond not applicable~Subscale scores are not reported~If not applicable is chosen, the item is not scored nor included n the final sum. Scoring is based on a total sum for all items as well as a subscale sum for each of the 6 dimensions. Higher scores are better. Total scores range from 0-96"|1 day from enrollment||||units on a scale||Inter-Quartile Range|Median
2605425|NCT02109458|Secondary|Positive Diagnostic Yield of Bronchoscopic Biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) Alone|Positive diagnostic yield of bronchoscopic biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) alone was defined by participants having benign or malignant pathology.|Approximately 1 week upon receipt of pathology report||||participants|||Number
2605351|NCT02110485|Primary|Decision Self-Efficacy Scale|"Decision Self-Efficacy will be measured using the Decision Self-Efficacy Scale which measures the participant's confidence in their ability to make decisions and consists of 11 questions regarding different aspects of decision making. This will be measured 1 hour after treatment decision has been made. The scale is a 5 point scale ranging from 0-not at all confident to 4-very confident. Higher scores are better.~Scoring includes summing all items, dividing by 11; and multiplying by 25. A score of 0 means extremely low self efficacy and a score of 100 means extremely high self efficacy"|1 hour following decision||||units on a scale||Inter-Quartile Range|Median
2605352|NCT02110381|Secondary|Adherence to Dual Modality Exercise (Device Guided Breathing + Isometric Hand Grip)|Subjects recorded sessions on a log; they were expected to complete 5 days/week for 8 weeks of single modality exercise for a minimum of 40 reported sessions. Results are reported as number of subjects reporting a minimum of 40 sessions.|8 weeks||||Participants|||Count of Participants
2605353|NCT02110381|Secondary|Adherence to Single Modality Exercise (Device Guided Breathing or Isometric Hand Grip)|Subjects recorded sessions on a log; they were expected to complete 5 days/week for 8 weeks of single modality exercise for a minimum of 40 reported sessions. Results are reported as number of subjects reporting a minimum of 40 sessions.|8 weeks||||Participants|||Count of Participants
2605354|NCT02110381|Primary|Change in Blood Pressure|Blood pressure was measured using an automated cuff with subject in a seated position for at least 5 minutes. Six measurements were recorded at 1-minute intervals. The mean was used in analysis.|8 weeks and 16 weeks|9 subjects in each group were analyzed. These subjects represent the individuals who passed started the intervention phase of the study.|||mmHg (millimeters of mercury)||Standard Deviation|Mean
2605355|NCT02110277|Secondary|Pathologic Diagnosis and in Vivo Imaging|To characterize the tissue images with pathologic diagnosis and to refine the system based on the characteristic features of in vivo imaging.|5 years|0 participants analyzed since study was terminated prematurely.||||||
2605356|NCT02110277|Primary|To Measure Photoacoustic Imaging (PAI)/Ultrasound Signature From Ovaries Prior to Surgery Using the Ratio of Deoxy/Oxy Hb|To develop a method of analyzing PAI ovarian tissue images measuring oxy and deoxy hemoglobin as well as the ratio of deoxy/oxy Hb to recognize the presence of ovarian abnormalities and compare changes seen with ultrasound to changes seen with PAI.|5 years|Study prematurely terminated and no results analyzed.||||||
2605357|NCT02110264|Secondary|Opioid Use Disorder|Number of participants meeting DSM-5 OUD (opioid use disorder) criteria via modified CIDI-2 Substance Abuse Module|6 months||||Participants|||Count of Participants
2605358|NCT02110264|Primary|Opioid Use|The primary objective is to compare outcomes of the three intervention groups, based on self-reports at 6-months post-intervention.|6 months||||Participants|||Count of Participants
2605359|NCT02110238|Primary|WOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) 0-100mm Pain subscale score Change from Baseline (CFB). Over weeks 3, 6, and 12 least square mean difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (0mm:None - 100mm:Extreme) pain subscale score Change from Baseline (CFB). A single estimate of least squares mean was calculated using data from baseline, weeks 3, 6, and 12.|Change from Baseline (CFB) over Weeks 3, 6, and 12|Per Protocol: All subjects with at least 1 post baseline primary outcome measure and no important protocol deviations.|||millimeter||95% Confidence Interval|Least Squares Mean
2605360|NCT02110225|Secondary|Electrorethinogram (ERG)|A full field and 30 Hz flicker ERG was performed according to international standards. Patients were treated with anesthetic and dilating drops prior to the ERG procedure.|Day 0, Weeks 12, 24, 36 and 48|Intent to treat (ITT) population: all randomized patients. The ITT population was used for the exploratory analyses of ocular parameters.|||Participants|||Count of Participants
2605361|NCT02110225|Secondary|Binocular Estermann Visual Field|Binocular visual field with Estermann grid testing a stimulus array of 120 points spread over an area extending approximately ±75° horizontally, 35° superiorly and 55° inferiorly while the patient looked steadily at the fixation target.|Day 0, Weeks 12, 24, 36 and 48|Intent to treat (ITT) population: all randomized patients. The ITT population was used for the exploratory analyses of ocular parameters.|||Participants|||Count of Participants
2605362|NCT02110225|Secondary|Microperimetry|MP1 microperimetry was analyzed to provide a more accurate measurement of retinal sensitivity in the central visual field, even in patients with unstable or extrafoveal fixation.|Day 0, Weeks 12, 24, 36 and 48|Intent to treat (ITT) population: all randomized patients. The ITT population was used for the exploratory analyses of ocular parameters.|||Participants|||Count of Participants
2605363|NCT02110225|Secondary|Ocular Coherence Tomography (OCT)|Ocular coherence tomography was performed to evaluate the cross-sectional anatomy of the macula and to document areas of retinal atrophy.|Day 0, Weeks 12, 24, 36 and 48|Intent to treat (ITT) population: all randomized patients. The ITT population was used for the exploratory analyses of ocular parameters.|||Participants|||Count of Participants
2605364|NCT02110225|Secondary|Fundus Imaging|A recordable fundus image (photo or other electronic format) showing the central 30 degrees was captured through a dilated pupil to document the appearance of the posterior pole.|Day 0, Weeks 24 and 48|Intent to treat (ITT) population: all randomized patients. The ITT population was used for the exploratory analyses of ocular parameters.|||Participants|||Count of Participants
2605365|NCT02110225|Secondary|Change in Goldmann Visual Field|The Goldmann field exam was performed to assess kinetic perimetry on all enrolled patients.|Weeks 12, 24, 36 and 48|Intent to treat (ITT) population: all randomized patients. The ITT population was used for the exploratory analyses of ocular parameters.|||degrees||Standard Deviation|Mean
2605366|NCT02110225|Secondary|Change From Baseline in Humphrey Visual Field 24-2|"The Humphrey Visual Field (HVF) analyzer is a tool for measuring the human visual field by providing information regarding the location of any disease processes or lesion(s) throughout the visual pathway.~In particular, Humphrey Visual Field 24-2 was used to assess static perimetry by measuring 24 degrees temporally and 30 degrees nasally and tests 54 points.~The Analyser projects a series of white light stimuli of varying intensities (brightness), throughout a uniformly illuminated bowl. The higher is the number of stimuli perceived by the patient, the better is the retina's ability to detect a stimulus at specific points within the visual field."|Weeks 12, 24, 36 and 48|Intent to treat (ITT) population: all randomized patients. The ITT population was used for the exploratory analyses of ocular parameters.|||dB||Standard Deviation|Mean
2605367|NCT02110225|Secondary|Change From Baseline in Contrast Sensitivity|Contrast sensitivity was assessed using a Mars chart and is expressed as a log contrast sensitivity (log CS) score given by the log CS value at the lowest contrast numeral just prior to two incorrectly identified numerals, minus a scoring correction. The higher is the number of characters properly read by the patient, the higher is the contrast sensitivity.|Weeks 12, 24, 36 and 48|Intent to treat (ITT) population: all randomized patients. The ITT population was used for the exploratory analyses of ocular parameters.|||score||Standard Deviation|Mean
2605368|NCT02110225|Primary|Presence of Anti-NGF Antibodies|Anti-NGF antibodies tests were performed at screening and at the end of treatment|At Day 0 and at week 24|Safety population: all patients who received at least one dose of study medication. The safety population was used to analyze all safety endpoints (primary objective).|||Participants|||Count of Participants
2605369|NCT02110225|Primary|Change in Ocular Tolerability - Dilated Fundus Ophthalmoscopy|Dilated fundus ophthalmoscopy was assessed for each eye evaluating the retina, macula, choroid and optic nerve head.|Day 0, Weeks 12, 24 and 48|Safety population: all patients who received at least one dose of study medication.|||Participants|||Count of Participants
2605370|NCT02110225|Primary|External Ocular Examination|External ocular examinations were done to assess, for each eye and at each visit, the motility of extraocular muscles, appearance and function of the eyelids.|Day 0, Weeks 1, 2, 6, 12, 24|Safety population: all patients who received at least one dose of study medication. The safety population was used to analyze all safety endpoints (primary objective).|||Participants|||Count of Participants
2605371|NCT02110225|Primary|Number of Participants With Normal or Abnormal Findings by Slit Lamp Examination|Slit Lamp Examination (SLE) (Biomicroscopy) was performed before the instillation of any dilating or anesthetic eye drops or fluorescein agents. SLE was executed to assess eyelids, lashes, conjunctiva, cornea, lens, iris and anterior chamber.|Day 0; Weeks 1, 2, 6, 12, 24, 36 and 48|s|||Participants|||Count of Participants
2605372|NCT02110225|Primary|Change in Intraocular Pressure (IOP)|Intraocular Pressure was measured using either Goldmann applanation tonometry or a handheld applanation tonometer (e.g. Tonopen) after the instillation of a topical anesthetic.IOP was assessed for each eye at day 0 and at week 2, 12 and 24|Weeks 2,12 and 24|Safety population: patients who received at least one dose of study medication. The safety population was used to analyze all safety endpoints (primary objective).|||mmHg||Standard Deviation|Mean
2605373|NCT02110225|Primary|Change in Best Corrected Distance Visual Acuity (BCDVA) (ETDRS Chart)|Best-Corrected Distance Visual Acuity (BCDVA) was assessed for each eye at each visit using an ETDRS visual acuity chart at 4 meters.|Weeks 1, 2, 6, 12, 24, 36, 48|Safety population: patients who received at least one dose of study medication. The safety population was used to analyze all safety endpoints (primary objective).|||Letters read correctly||Standard Deviation|Mean
2605374|NCT02110225|Primary|Change in Ocular Tolerability - VAS|"A global ocular discomfort score was determined using a 100 mm Visual Analogue Scale (VAS) on which 0 means no symptoms and 100 means the worst possible discomfort.~Specific ocular symptoms to be assessed with the VAS included: foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, photophobia.~For ocular tolerability analysis, mixed models for repeated measures were applied using various ocular tolerability parameters as response variable, treatment, visit and treatment by visit interaction as fixed effects, and baseline value as covariate."|Weeks 1, 2, 6, 12, 24|Safety population: patients who received at least one dose of study medication. The safety population was used to analyze all safety endpoints (primary objective).|||units on a scale||Standard Deviation|Mean
2605375|NCT02110225|Primary|Number of Participants With Serious and Non-Serious Adverse Events|Twenty-seven patients of the Safety population experienced at least one treatment-emergent adverse event, 11 patients in the rhNGF 60 μg/ml arm, 13 patients in the rhNGF 180 μg/ml arm and 3 patients in the vehicle arm.|up to 48 weeks|Safety population: all patients who received at least one dose of study medication. The safety population was used to analyze all safety endpoints (primary objective).|||Participants|||Count of Participants
2605376|NCT02110147|Secondary|Patients With Levels of Uridine in the Plasma Consistent With Expected Therapeutic Benefit|HOA is principally a chronic uridine deficiency disorder. The purpose of uridine triacetate administration is to provide an exogenous source of uridine. Therefore, plasma uridine levels were assessed at various time points (prior to dosing, 30 min, 1 hour, 2 hours, 4 hours, 6 hours and 8 hours) following uridine triacetate dosing to ensure levels of uridine consistent with previously observed symptomatic improvement from administration of uridine were achieved. The table below shows the number of participants with uridine levels consistent with or exceeding previously observed symptomatic improvements.|Days 1 and 28||||Participants|||Count of Participants
2605377|NCT02110147|Secondary|Patients With Stable or Improved Orotic Acid and Orotidine Levels|Significantly elevated urine orotic acid levels are characteristic of patients with HOA. Therefore, urinary orotic acid and orotidine levels were assessed in patients at baseline (on uridine or uridine naïve) and on Day 28 and Day 42 following the switch to uridine triacetate. The table below shows the number of participants with stable or improved orotic acid and orotidine levels at Day 28 and Day 42 compared to baseline.|Days 28 and 42||||Participants|||Count of Participants
2605378|NCT02110147|Primary|Patients With Stable Predetermined Principal Hematologic Parameters|Hereditary orotic aciduria patients will be taking uridine triacetate as replacement therapy for uridine. The primary outcome measure will be based on predetermined principal hematologic parameter(s) based on the patient's response(s) to oral uridine when dosing is switched from oral uridine to oral uridine triacetate. The primary outcome measure in patients not previously receiving uridine replacement therapy will be improvement in the patient's principal affected hematologic parameter(s) on Days 28 and 42 compared to baseline (Day 0) of the Main Study.|Days 28 and 42||||Participants|||Count of Participants
2605379|NCT02109939|Other Pre-specified|Generalized Anxiety Disorder 7-item (GAD-7) Scale|The mean change in Generalized Anxiety Disorder 7-item (GAD-7) scale from baseline to week 12|baseline to week 12|||||||
2605380|NCT02109939|Other Pre-specified|Generalized Anxiety Disorder 7-item (GAD-7) Scale|The mean change in Generalized Anxiety Disorder 7-item (GAD-7) scale from baseline to week 8|baseline to week 8|||||||
2605381|NCT02109939|Other Pre-specified|Generalized Anxiety Disorder 7-item (GAD-7) Scale|The mean change in Generalized Anxiety Disorder 7-item (GAD-7) scale from week 12 to week 24|week 12 to week 24|||||||
2605680|NCT02107339|Primary|Hydromorphone Use at 24 Hours||Use of hydromorphone at 24 hours||||milligrams||Inter-Quartile Range|Median
2605382|NCT02109939|Secondary|Percentage of Remitters at Week 24 Defined as HAM-D17 ≤7 in the GeneSight Psychotropic Tested Treatment Group|"Adjusted percentage of remitters at Week 8 defined as a score ≤7 in the 17-item Hamilton Depression Rating Scale (HAM-D17) in each treatment group. Scores range from 0 to 50, and lower scores are better outcomes.~*Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding may have occurred prior to week 12 assessments, all data collected at week 12 were considered unblinded and are not reported."|Baseline to week 24 visit info|Per Protocol|||percentage of subjects|||Number
2605383|NCT02109939|Secondary|Percentage of Responders at Week 24 for HAM-D17 in the GeneSight Psychotropic Tested Treatment Group|Adjusted percentage of responders at Week 24 in the GeneSight Psychotropic Tested treatment group on the 17-item Hamilton Depression Rating Scale (HAM-D17). A responder is defined as a participant with at least a 50% decrease from baseline in total scale score. Scores range from 0 to 50, and lower scores are better outcomes.|Baseline to week 24 visit info|Per Protocol|||percentage of subjects|||Number
2605384|NCT02109939|Secondary|Time to Response/Remission of Depressive Symptoms Over 12 Weeks;|*Comment*: Time to response/remission is not an outcome measure that can accurately be reported from the way the data was collected. As specified in the updated SAP before the blind was broken, this was not analyzed and reported. Additionally, for patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding may have occurred prior to week 12 assessments, data collected at week 12 were considered unblinded and are not reported.|week 4, 8, and 12 visit info|||||||
2605385|NCT02109939|Secondary|Percentage of Remitters at Week 8 Defined as PHQ-9 <5 in Each Treatment Group|Adjusted percentage of remitters at Week 8 in each treatment group on the 9-item Patient Health Questionnaire (PHQ-9). A remitter is defined as a participant with score <5 on the PHQ-9. Scores range from 0 to 27 with lower scores being better outcomes.|week 8 visit info|Intent-to-treat|||percentage of subjects|||Number
2605386|NCT02109939|Secondary|Percentage of Remitters at Week 8 Defined as QIDS-C16 ≤ 5 in Each Treatment Group|Adjusted percentage of remitters at Week 8 in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) in each treatment group. A remitter is defined as a subject with a score ≤ 5. Scores range from 0 to 27 with lower scores being better outcomes.|week 8 visit info|Intent-to-treat|||percentage of subjects|||Number
2605387|NCT02109939|Secondary|Percentage of Responders at Week 12 for CGI-EI|*Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.|Week 12 visit info|||||||
2605388|NCT02109939|Secondary|Percentage of Responders at Week 12 for CGI-I|*Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.|Week 12 visit info|||||||
2605389|NCT02109939|Secondary|Percentage of Responders at Week 12 for CGI-S|*Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.|Week 12 visit info|||||||
2605390|NCT02109939|Secondary|Percentage of Responders at Week 12 for PHQ-9|*Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.|Week 12 visit info|||||||
2605391|NCT02109939|Secondary|Percentage of Responders at Week 12 for QIDS-C16|*Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.|Week 12 visit info|||||||
2605392|NCT02109939|Secondary|Percentage of Remitters at Week 12 Defined as CGI-S ≤1|*Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.|week 12 visit info|||||||
2605393|NCT02109939|Secondary|Percentage of Remitters at Week 12 Defined as PHQ-9 <5|*Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.|week 12 visit info|||||||
2605394|NCT02109939|Secondary|Percentage of Remitters at Week 12 Defined as QIDS-C16 ≤5|*Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.|week 12 visit info|||||||
2605395|NCT02109939|Secondary|Percentage of Responders at Week 8 for PHQ-9|Adjusted percentage of responders at Week 8 in each treatment group on the 9-item Patient Health Questionnaire (PHQ-9). A responder is defined as a participant with at least 50% decrease from baseline in total scale score. Scores range from 0 to 27 with lower scores being better outcomes.|Week 8 visit info|Intent-to-treat|||percentage of subjects|||Number
2605396|NCT02109939|Secondary|Percentage of Responders at Week 8 for QIDS-C16|Adjusted percentage of responders at Week 8 in each treatment group on the 16-item Quick Inventory of Depression Symptomology (QIDS-C16). A responder is defined as a participant with at least 50% decrease from baseline in total scale score. Scores range from 0 to 27 with lower scores being better outcomes.|Week 8 visit info|Intent-to-treat|||percentage of subjects|||Number
2605426|NCT02109458|Primary|Incidence of Pneumothorax|Presence of pneumothorax assessed in participants with successful completion of biopsy.|Immediately after procedure||||participants|||Number
2605427|NCT02109458|Primary|Feasibility|Feasibility assessed by number of participants with successful completion of biopsy (i.e. a biopsy was able to be obtained to collect a tissue sample)|Immediately following procedure||||participants|||Number
2605397|NCT02109939|Secondary|Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 24 Weeks|Evaluate the impact of GeneSight Psychotropic on response to psychotropic treatment as judged by the mean percent change in the 17-item Hamilton Depression (HAM-D17) score from baseline to end of Week 24 of the study. Scores range from 0 to 50, and lower scores are better outcomes. Percent change is defined as (week 24 score -baseline score) / (baseline score) x 100.|Baseline to week 24 visits|Per Protocol - Due to unblinding before week 12 there was no longer a treatment as usual and guided treatment arm and it was pre-specified in the Protocol to include only the GeneSight Psychotropic Tested Arm/Group for this Outcome Measure|||percentage of change||Standard Error|Mean
2605398|NCT02109939|Secondary|Time to Response/Remission of Depressive Symptoms Over 8 Weeks;|*Comment*: Time to response/remission is not an outcome measure that can accurately be reported from the way the data was collected. As specified in the updated SAP before the blind was broken, this was not analyzed or reported.|week 4 and 8 visit info|||||||
2605399|NCT02109939|Secondary|Percentage of Remitters at Week 8 Defined as HAM-D17 ≤7 Each Treatment Group;|Adjusted percentage of remitters at Week 8 defined as a score ≤7 in the 17-item Hamilton Depression Rating Scale (HAM-D17) in each treatment group. Scores range from 0 to 50, and lower scores are better outcomes.|week 8 visit info|Per Protocol|||percentage of subjects|||Number
2605400|NCT02109939|Secondary|Percentage of Remitters at Week 12 Defined as HAM-D17 ≤7|*Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.|week 12 visit info|||||||
2605401|NCT02109939|Secondary|Percentage of Responders at Week 12 for HAM-D17|*Comment*: For patients in TAU, clinicians were blinded to the pharmacogenomic test result until after completion of the week 8 visit. Because unblinding might have occurred for some patients prior to week 12 assessments, data collected at week 12 were no longer considered blinded and are not analyzed or reported.|Week 12 visit info|||||||
2605402|NCT02109939|Secondary|Percentage of Responders at Week 8 for HAM-D17|Adjusted percentage of responders at Week 8 in each treatment group on the 17-item Hamilton Depression Rating Scale (HAM-D17). A responder is defined as a participant with at least a 50% decrease from baseline in total scale score. Scores range from 0 to 50, and lower scores are better outcomes.|Week 8 visit info|Per Protocol|||percentage of subjects|||Number
2605403|NCT02109939|Secondary|Percent Change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) Score From Baseline to 8 Weeks|Mean percent change in the 16-item Quick Inventory of Depression Symptomology (QIDS-C16) score from baseline to end of Week 8 of the study. Scores range from 0 to 27 with lower scores being better outcomes. Percent change is defined as (week 8 score - baseline score) / (baseline score) x 100.|from baseline to end of Week 8|Intent-to-Treat|||percentage of change||Standard Error|Least Squares Mean
2605404|NCT02109939|Primary|Percent Change in the 17-item Hamilton Depression (HAM-D17) Score From Baseline to 8 Weeks|Evaluate the impact of GeneSight Psychotropic on response to psychotropic treatment as judged by the mean percent change in the 17-item Hamilton Depression (HAM-D17) score from baseline to end of Week 8 of the study. Scores range from 0 to 50, and lower scores are better outcomes. Percent change is defined as (week 8 score -baseline score) / (baseline score) x 100.|from baseline to end of Week 8|Per-Protocol|||percentage of change||Standard Error|Least Squares Mean
2605405|NCT02109809|Secondary|Immunomodulatory/Immuno-suppressive Effects|T, natural killer (NK)T, regulatory T cell (Treg), B, NK, dendritic cell (DC) cell subsets, cell activation status and functional potential through cytokine and chemokine expression will be identified. Descriptive statistics (with 95% confidence intervals) will be calculated at each assessment time point.|Up to 1 year|Only 1 participant on study treatment and there are concerns of patient privacy.||||||
2605406|NCT02109809|Primary|Failure Free Survival (FFS) as Assessed by Scoring for Chronic GvHD - Specific Core Measures|Estimated along with 95% confidence intervals (CI). Descriptive statistics will be calculated and presented for GvHD summary scores by dose level and visit.|Time from baseline to date of last follow-up or failure event, assessed at day 180|Only 1 participant on study treatment and there are concerns of patient privacy.||||||
2605407|NCT02109809|Primary|Incidence of Adverse Events, Scored as Per Common Toxicity Criteria Version 4.0|Toxicities (grade 2 and higher) will be reported as number of occurrences.|At day 180|Only 1 participant on study treatment and there are concerns of patient privacy.||||||
2605408|NCT02109731|Primary|Delta of Apnea Hypopnea Index (AHI) as Measured by Polysomnography (PSG)|The pre-study AHI (before the NAP treatment was applied) was measured and quantified and compared to the post study AHI (after three months of NAP treatment) and the difference between pre and post therapy is reported. The AHI is an hourly rate of breathing disturbance (apneas and hypopneas per hour) that is calculated while subjects are evaluated during an overnight sleep study, with polysomnography applied (PSG). For example, while a subject is spending the night in the PSG laboratory sleeping, his/her breathing is evaluated for evidence of apneas and hypopneas during various stages of sleep. Sleep is measured with electroencephalography. And breathing is measure with respiratory excursions via chest/abdominal plethysmography recordings and airflow from the nose/mouth.|three months|subjects with a diagnosis of OSA|||events per hour||Standard Deviation|Mean
2605409|NCT02109640|Secondary|Pain Scores|"Overall Benefit of Analgesia Score (OBAS): Score range 0-28 with low score=high benefit. Summed from subscales of 0-4 for the following questions:~Please rate your current pain at rest on a scale between 0⁄4 minimal pain and 4⁄4 maximum imaginable pain~Please grade any distress and bother from vomiting in the past 24 h (0⁄4 not at all to 4⁄4 very much)~Please grade any distress and bother from itching in the past 24 h (0⁄4 not at all to 4⁄4 very much)~Please grade any distress and bother from sweating in the past 24 h (0⁄4 not at all to 4⁄4 very much)~Please grade any distress and bother from freezing in the past 24 h (0⁄4 not at all to 4⁄4 very much)~Please grade any distress and bother from dizziness in the past 24 h (0⁄4 not at all to 4⁄4 very much)~How satisfied are you with your pain treatment during the past 24 h (0⁄4 not at all to 4⁄4 very much) Lehmann N. British Journal of Anaesthesia 105 (4): 511-18 (2010)"|Postoperative day 3||||units on a scale||Full Range|Median
2605410|NCT02109640|Secondary|Total Opioid Analgesia Consumption|Total dose of systemic and oral Oxycodone or Targinact taken in hospital or at home until discontinued by the participant|Total postoperative period of analgesic consumption, an average of 1 week||||milligram morphine equivalents||Standard Deviation|Mean
2605412|NCT02109562|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAE)|"An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date. AEs are determined by the Investigator to be related or not related to the study drug.~A serious AE (SAE) is defined by federal regulation as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Although a subject may have had 2 or more adverse experiences the subject is counted only once in a category. The same subject may appear in different categories."|Day 1 to Week 8|Safety population|||Participants|||Count of Participants
2605413|NCT02109562|Secondary|Mixed Model for Repeated Measures (MMRM) Analysis of Change From Baseline to End of Treatment in Clinical Global Impression - Severity Scale (CGI-S)|"The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Negative change from baseline scores indicate improvement in the severity of illness.~Estimates (least square means and standard errors), 2-sided confidence intervals, and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix."|Day 1 prior to treatment (Baseline), Days 15, 29, 43 and 57 or early discontinuation|Intent to treat population (ITT)|||units on a scale||Standard Error|Least Squares Mean
2605414|NCT02109562|Primary|Mixed Model for Repeated Measures (MMRM) Analysis of Change From Baseline to End of Treatment in the Positive and Negative Syndrome Scale (PANSS) Total Score|"The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor judgement, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 PANSS items and ranges from 30 to 210, with 30 indicating absence of symptoms of schizophrenia and 210 indicating extreme ratings of all 30 symptoms. Negative change from baseline scores indicate improvements in symptoms.~Estimates (least square means and standard errors), 2-sided confidence intervals, and -1-sided P values are based on a repeated-measures linear regression model of the change from baseline score, with fixed effects for visit as a categorical variable, baseline score, treatment and treatment by visit interaction, assuming an unstructured covariance matrix."|Day 1 prior to treatment (Baseline), Days 15, 29, 43 and 57 or early discontinuation|Intent to treat (ITT) population|||units on a scale||Standard Error|Least Squares Mean
2605415|NCT02109497|Secondary|Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Event||Up to 19 days after first dose of caffeine|Safety population|||participants|||Number
2605416|NCT02109497|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) of Caffeine After a Dose of PBT2 250mg|PK Per Protocol Population, as defined as all participants who received scheduled doses of both caffeine and PBT2 and had sufficient samples collected to determine PK parameters from plasma concentrations of caffeine on Day 1 and Day 12.|prior to dose on Day 1 and 12 and then 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48 hours post each dose.||||ng*hr/mL||Standard Deviation|Mean
2605417|NCT02109484|Secondary|Rotavirus Shedding After Administration of Rotarix in Infants Receiving 3 Doses of Vaccine or Placebo.|Percent of infants who shed rotavirus at any timepoint after receiving 3 doses of study vaccine and one dose of Rotarix. Infants received Rotarix vaccination beginning on Day 84. Stool specimens were collected from these infants on the 5th, 7th and 9th day following first administration of Rotarix. This test was performed as a novel functional assessment of the ability to suppress local gut multiplication of the vaccine strain contained in Rotarix.|Rotarix vaccination on Day 84 to day 91||||Participants|||Count of Participants
2605418|NCT02109484|Primary|Number/Percentage of Infants With Neutralizing Antibody Response to WA Strain (G1[P8])|Seroresponse is defined as 4 fold rise in Geometric Mean Titer (GMT) between pre-(baseline) and post vaccination (4 weeks after third injection).An unadjusted serioresponse was defined as an increase of 4 times or more in titers between baseline and 4 weeks after the 3rd injection. Adjusted IgG and neutralizing antibody post injection titres accounted for the decay in maternal antibodies using the half-life calculated from participants in the placebo group with detectable baseline titers higher than those at the post injection visit.|Baseline to Day 84|Enrolled infants who received placebo, 10 mcg, 30 mcg or 60 mcg V2-VP8.|||Participants|||Count of Participants
2605419|NCT02109484|Primary|Number/Percentage of Infants With Anti-P2-VP8 IgG to P[8] Seroresponses|Seroresponse is defined as 4 fold rise in Geometric Mean Titer (GMT) between pre-(baseline) and post vaccination (4 weeks after third injection).An unadjusted serioresponse was defined as an increase of 4 times or more in titers between baseline and 4 weeks after the 3rd injection. Adjusted IgG and neutralizing antibody post injection titres accounted for the decay in maternal antibodies using the half-life calculated from participants in the placebo group with detectable baseline titers higher than those at the post injection visit.|Baseline to day 84||||Participants|||Count of Participants
2605420|NCT02109484|Primary|Number/Percentage of Infant Participants With Anti-P2-VP8 IgA to P[8] Seroresponse.|Seroresponse is defined as 4 fold rise in Geometric Mean Titer (GMT) between pre-(baseline) and post vaccination (4 weeks after third vaccination). Confidence intervals are displayed as percentages.|Baseline to day 84|Enrolled infants who received 3 vaccinations and with pre and post-vaccination immunologic parameters measured|||Participants|||Count of Participants
2605421|NCT02109484|Primary|Number of Participants Reporting Any Non-Serious Adverse Event|all adverse events will be recorded over the duration of the 6 month follow up period.|6 mo following first vaccination||||Participants|||Count of Participants
2605422|NCT02109484|Primary|Number of Participants With Serious Adverse Events|Number of participants experiencing a Serious Adverse Event within 28 days of a vaccination and at any time during the study|within 28 days of a study dose and at any time|All subjects that received at least one dose of P2-VP8 vaccine or placebo|||Participants|||Count of Participants
2605708|NCT02107014|Primary|Change in PDGF-BB From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2605428|NCT02109445|Secondary|European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-C30) - Phase 2|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.|Baseline till end of treatment|As Phase 2 was not performed due to early termination, there were no participants to analyse for this outcome measure.||||||
2605429|NCT02109445|Secondary|Change From Baseline in European Quality of Life Questionnaire (EQ-5D) - Phase 2|EQ-5D: 6-item participant rated questionnaire to assess health-related quality of life in terms of a single utility score. There were 2 components: a Health State Profile and a Visual Analog Scale. Published weights are available that allow for the creation of a single summary score. Overall scores range from 0-1, with low scores representing a higher level of dysfunction.|Baseline till end of treatment|As Phase 2 was not performed due to early termination, there were no participants to analyse for this outcome measure.||||||
2605430|NCT02109445|Secondary|Brief Pain Inventory-Short Form (BPI-sf) Score - Phase 2|BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference.|Day 1 of Cycle 1 and subsequent cycles; end of treatment|As Phase 2 was not performed due to early termination, there were no participants to analyse for this outcome measure.||||||
2605431|NCT02109445|Secondary|Progression-free Survival (PFS) in Phase 2|PFS was defined as the time from the date of first dose to the date of the first documentation of objective tumor progression or death on study due to any cause, whichever occurred first. PFS (in months) was calculated as (first event date - date of randomization +1) divided by 30.4.|From start of study treatment, collected every 3 months until death (up to 5 years)|All randomized participants in Phase 2 were to be analyzed for PFS. However, since Phase 2 was not carried out due to early termination, no subjects were analyzed for PFS.||||||
2605432|NCT02109445|Secondary|1-year and 2-year OS in Phase 2|Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.|From start of study treatment, collected every 3 months until death (up to 5 years)|All randomized participants in Phase 2 were to be analyzed for OS. However, since Phase 2 was not carried out due to early termination, no subjects were analyzed for OS.||||||
2605433|NCT02109445|Secondary|Duration of Response (DR) for Phases 1 and 2|Duration of response (DR) defined as the difference in days between the first date criteria for progression occurred or the participant died due to any cause and the first date that criteria for a PR or CR were met. DR calculated as (months) = (progression/death date - first date of OR + 1) divided by 30.4. CR: disappearance of all target lesions. PR: at least 30% decrease in the sum of diameters of target lesions.|Baseline, every 8 weeks until disease progression or unacceptable toxicity (up to 5 years)|No participants were analyzed for this outcome measure as there were no participants with OR in Phase 1 and Phase 2 was not done.||||||
2605434|NCT02109445|Secondary|Number of Participants With Objective Response (OR) in Phase 2|"Number of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST).~CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 mm). No new lesions. PR was defined as more than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions."|Screening till 28-35 days post last administration of study drug|No participants were analyzed for this outcome measure as Phase 2 was not done.||||||
2605435|NCT02109445|Secondary|Number of Participants With Objective Response (OR) in Phase 1|"Number of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST).~CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 mm). No new lesions. PR was defined as more than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions."|Screening till 28-35 days post last administration of study drug|All enrolled participants in Phase 1 who were eligible for enrollment, received study treatment, had measurable disease and adequate baseline assessments, and had at least 1 on-study tumor assessment, were considered evaluable for response. Only 1 participant was evaluable for OR in Phase 1.|||participants|||Number
2605436|NCT02109445|Secondary|Plasma Decay Half-life (t1/2) for PF-03084014, Nab-P and GEM in Phase 2||Cycle 1 Day 1 till end of last cycle|As Phase 2 was not performed, no participants were analyzed for this outcome measure.||||||
2605437|NCT02109445|Secondary|Plasma Decay Half-life (t1/2) for Nab-P and GEM in Phase 1||Cycle 1 (Days 1 and 15 for gemcitabine; Days 1-3 and 15-17 for nab-paclitaxel)|All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.|||hours||Standard Deviation|Mean
2605438|NCT02109445|Secondary|Volume of Distribution at Steady State (Vss) for PF-03084014, Nab-P and GEM in Phase 2||Cycle 1 Day 1 till end of last cycle|As Phase 2 was not performed, no participants were analyzed for this outcome measure.||||||
2605439|NCT02109445|Secondary|Volume of Distribution at Steady State (Vss) for Nab-P and GEM in Phase 1||Cycle 1 (Days 1 and 15 for gemcitabine; Days 1-3 and 15-17 for nab-paclitaxel)|All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.|||liters||Geometric Coefficient of Variation|Geometric Mean
2605441|NCT02109445|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-03084014, Nab-P and GEM in Phase 1||PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15.|All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.|||hours||Full Range|Median
2605442|NCT02109445|Secondary|Systemic Clearance (CL) of PF-03084014, Nab-P and GEM in Phase 2||Cycle 1 Day 1 till end of last cycle|As Phase 2 was not performed, no participants were analyzed for this outcome measure.||||||
2605443|NCT02109445|Secondary|Systemic Clearance (CL) of Gemcitabine in Phase 1||Cycle 1 Days 1 and 15|All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.|||liter (L)/minute (min)||Geometric Coefficient of Variation|Geometric Mean
2605444|NCT02109445|Secondary|Systemic Clearance (CL) of Nab-paclitaxel in Phase 1||Cycle 1 Days 1-3, and 15-17|All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.|||liter (L)/hour (hr)||Geometric Coefficient of Variation|Geometric Mean
2605445|NCT02109445|Secondary|Maximum Observed Plasma Concentration (Cmax) for PF-03084014, Nab-P and GEM in Phase 2||Cycle 1 Day 1 till end of last cycle|As Phase 2 was not performed, no participants were analyzed for this outcome measure.||||||
2605446|NCT02109445|Secondary|Maximum Observed Plasma Concentration (Cmax) for PF-03084014, Nab-P and GEM in Phase 1||PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15.|All treated participants who had at least 1 of the PK parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2605447|NCT02109445|Secondary|Area Under the Concentration-time Curve (AUC) for PF-03084014, Nab-P and Gemcitabine in Phase 2|AUC included AUC from time 0 extrapolated to infinite time (AUCinf), AUC from time 0 to end of dosing interval (AUCtau), and AUC from time 0 to last measured concentration (AUClast).|Cycle 1 Day 1 till end of last cycle|As Phase 2 was not performed, no participants were analyzed for this outcome measure.||||||
2605448|NCT02109445|Secondary|Area Under the Concentration-time Curve (AUC) for PF-03084014, Nab-P and Gemcitabine in Phase 1|AUC included AUC from time 0 extrapolated to infinite time (AUCinf), AUC from time 0 to end of dosing interval (AUCtau, tau=12 hours), and AUC from time 0 to last measured concentration (AUClast).|PF-03084014: Cycle 1 Days 3, 15, 22; Day 1 of subsequent cycles; and end of treatment. nab-P: Cycle 1 Days 1-3 and 15-17. Gemcitabine: Cycle 1 Days 1 and 15.|All treated participants who had at least 1 of the pharmacokinetic (PK) parameters of interest of any of the study drugs. n=number of evaluable participants for that parameter at the specified time point.|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2605449|NCT02109445|Secondary|Number of Participants With Worsening QTc Results in Phase 2|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) were corrected for heart rate (QTc) using Fridericia (QTcF) and Bazett (QTcB) formulas. Any change from baseline in QTc was considered as worsening in ECG and was classified accordingly to the Common Terminology Criteria (CTC) grade. Grading was as follows: prolonged QTc of 450 to 480 milliseconds (msec)=Grade 1, 481 to 500 msec=Grade 2, more than or equal to (>=) 501 msec on at least 2 seperate ECGs=Grade 3, >=501 or more than (>) 60 msec change from baseline and Torsade de pointes or polymorphic ventricular tachycardia or signs of serious arrhythmia=Grade 4.|Screening, Cycle 1 Days 1 and 22, Cycles 2 and 3 Day 1, end of treatment|Due to early termination, Phase 2 was not performed and thus no participants were analyzed for this outcome measure.||||||
2605450|NCT02109445|Secondary|Number of Participants With Worsening QTc Results in Phase 1|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) were corrected for heart rate (QTc) using Fridericia (QTcF) and Bazett (QTcB) formulas. Any change from baseline in QTc was considered as worsening in ECG and was classified accordingly to the Common Terminology Criteria (CTC) grade. Grading was as follows: prolonged QTc of 450 to 480 milliseconds (msec)=Grade 1, 481 to 500 msec=Grade 2, more than or equal to (>=) 501 msec on at least 2 seperate ECGs=Grade 3, >=501 or more than (>) 60 msec change from baseline and Torsade de pointes or polymorphic ventricular tachycardia or signs of serious arrhythmia=Grade 4.|Screening, Cycle 1 Days 3 and 22, Cycles 2 and 3 Day 1, end of treatment|All enrolled participants in Phase 1 who had at least 1 ECG assessment after receiving PF-03084014.|||participants|||Number
2605451|NCT02109445|Secondary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs at Phases 1 and 2|Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, heart rate, weight and body surface area.|Baseline up to 28-35 days after treatment discontinuation|All enrolled participants in Phase 1, or all randomized participants in Phase 2, who received at least 1 dose of study medication. Due to early termination of the study, vital sign evaluations were not performed.||||||
2605452|NCT02109445|Secondary|Number of Participants With Laboratory Abnormalities in Phase 2|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (urea, creatinine, glucose, calcium, sodium, potassium, chloride, magnesium, phosphate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid); urinalysis (protein, blood, microscopy[if urine tested positive for blood or protein]).|Screening; Days 1, 8, 15 of each cycle; up to 28-35 days post last administration of study drug|Due to early termination, Phase 2 was not performed and thus no participants were included in this analysis.||||||
2605467|NCT02109107|Secondary|Subject Satisfaction With Study Outcome Rating|"At the end of the study procedure administration phase, the subject was asked to indicate how satisfied or dissatisfied they were with any change noticed in the appearance of the thighs, hips, waist and upper abdomen area after having received the procedures with the EZ6?, using the following five-point scale: Very Satisfied; Somewhat Satisfied; Neither Satisfied nor Dissatisfied; Not Very Satisfied; Not at All Satisfied"|6 weeks||||participants|||Number
2605453|NCT02109445|Secondary|Number of Participants With Laboratory Abnormalities in Phase 1|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (urea, creatinine, glucose, calcium, sodium, potassium, chloride, magnesium, phosphate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid); urinalysis (protein, blood, microscopy[if urine tested positive for blood or protein]).|Screening; Cycle 1 Days 1, 8, 15, 22; up to 28-35 days post last administration of study drug|All participants who received any study treatment.|||participants|||Number
2605454|NCT02109445|Secondary|Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 2|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. Severity was graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Grade 1=mild, Grade 2=moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=life-threatening.|Baseline up to 28-35 days post last administration of study drug|No participants were analyzed since Phase 2 was not performed.||||||
2605455|NCT02109445|Secondary|Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment in Phase 1|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. Severity was graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Grade 1=mild, Grade 2=moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=life-threatening.|Baseline up to 28-35 days post last administration of study drug|All enrolled participants in Phase 1 who received at least 1 dose of study medication.|||participants|||Number
2605456|NCT02109445|Primary|Overall Survival (OS) in Phase 2|Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.|From start of study treatment, collected every 3 months until death (up to 5 years)|All randomized participants in Phase 2 were to be analyzed for OS. However, since Phase 2 was not carried out due to early termination, no subjects were analyzed for OS.||||||
2605457|NCT02109445|Primary|Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1|DLT was defined as any of the following events occurring during the first cycle of treatment and considered at least possibly-related to study medication: any Grade 3 or 4 clinically-relevant non-hematologic and/or hematologic toxicity, delay of more than 2 weeks in receiving the next scheduled cycle due to persisting treatment-related toxicities.|Cycle 1 (28 days)|All enrolled participants who received study treatment and who either experienced DLT during the first cycle, or completed the 1-cycle observation period, were considered evaluable for DLT. Only 2 of the 3 participants were evaluable for DLTs.|||participants|||Number
2605458|NCT02109432|Primary|Weight Change (kg)|KG weight change from Baseline to 6 weeks|Baseline to 6 weeks||||kg||Standard Deviation|Mean
2605459|NCT02109419|Primary|Reliability and Validity of HHT's Computerized Assessments as Assessed by Correlation Analysis.|Assess the reliability, validity and internal consistency of the HHT-D (Helping Hands Depression Test; min and max score is 0 and 30, respectively; higher scores reflect higher depression) and the HHT-G (Helping Hands global cognitive function screener; min and max scores are 0 and 30, respectively; higher scores reflect better cognition). In addition to assessing reliability, the HHT scales' validity was examined by correlating scores on the HHT scales with existing and already validated pen-and-paper assessments, which included the Mini-Mental State Exam (MMSE; min and max scores are 0 and 30, higher scores reflect better cognitive functioning), and the Geriatric Depression Scale (GDS; min and max scores are 0 and 15, respectively; higher scores reflect higher depression).|Visit completed over 16 day period|Males and females between the ages of 60 and 85 years, inclusive, with MMSE scores of 10-30, inclusive.|||Units on a scale||Standard Deviation|Mean
2605460|NCT02109172|Primary|Weighted Mean (0-24hr) Change From Baseline FEV1 (Forced Expiratory Volume in 1 Second)|Weighted mean (0-24hr) Change from baseline FEV1 (forced expiratory volume in 1 second). Measurement is change from baseline.|Following the Day 7 AM dose -12 hours post-dose and 24 hours post-dose||||mL||Standard Error|Least Squares Mean
2605461|NCT02109159|Secondary|Number of Access to the Video Generated as a Result of Video Sharing by Each Participant|The distribution of the numbers of access to the video that each participant generated will be compared using the data collected with the computer programme to track access to the videos.|After 14 days of sending the online videos||||Number of views||95% Confidence Interval|Mean
2605462|NCT02109159|Primary|Number of Participants Who Forwarded the Video|A computer programme to track the access to the videos has been made. The number of people who forwarded the video will be analysed based on the data collected with this programme.|After 14 days of sending the online videos||||participants|||Number
2605463|NCT02109133|Other Pre-specified|Incidence of Residual Neuromuscular Blockade||During 24hours after operation||||participants|||Number
2605464|NCT02109133|Other Pre-specified|Post-operative Nausea||During 24hours after operation||||events|||Number
2605465|NCT02109133|Secondary|Overall Surgical Condition|overall surgical conditions using the 5-point rating scale as previously described: Grade 5 (optimal), optimal surgical conditions; grade 4 (good), nonoptimal conditions, but an intervention is not required; grade 3 (acceptable), wide surgical view, but an intervention can improve surgical conditions, grade 2 (poor), inadequate conditions, there is a visible view, but an intervention is necessary to ensure acceptable surgical conditions; grade 1 (extremely poor), inability to perform surgery; therefore, intervention is necessary.|At the end of the Steep trendelenburg position, an average of 1 hour||||units on a scale||Inter-Quartile Range|Median
2605466|NCT02109133|Primary|Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade|maximum intraocular pressure during RALRP under deep neuromuscular blockade after being positioned in the steep Trendelenburg position with CO2 pneumoperitoneum under deep neuromuscular blockade|Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position||||mmHg||Standard Deviation|Mean
2605709|NCT02107014|Primary|Change in ENA-78 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2605468|NCT02109107|Secondary|Change in Body Mass Index (BMI)|Body mass index (BMI) was measured in kilograms per meter squared (kg/m2) at each evaluation point. The change in BMI measured at 6 weeks post-procedure administration relative to baseline was calculated. An increase in BMI indicated that BMI increased across the study evaluation period which is negative for study success, while a decrease in BMI indicated that BMI decreased across the study evaluation period which is positive for study success.|Baseline and 6 weeks||||kg/m2||Standard Deviation|Mean
2605469|NCT02109107|Secondary|Change in Body Weight|Body weight was measured in pounds at each evaluation point. The change in body weight measured in pounds at 6 weeks post-procedure administration relative to baseline was calculated. An increase in body weight indicated that weight was gained across the study evaluation period while a decrease in body weight indicated that weight was lost across the study evaluation period.|Baseline and 6 weeks||||pounds||Standard Deviation|Mean
2605470|NCT02109107|Primary|Change in Combined Circumference Measurements|"Combined circumference measurement is calculated as the sum of the measurements for the individual body areas of the right and left thighs, hips, waist and upper abdomen. Change in combined circumference measurements is calculated as the difference in measurements from baseline to after completion of the 6-week procedure administration period. A negative (-) change indicates a reduction in combined circumference measurement across the evaluation period and is positive for study success. A positive (+) change indicates an increase in combined circumference measurements across the evaluation period and is negative for study success.~A mean change for the study subject group of -3.0 inches or more in combined circumference measurements will be considered a clinically meaningful and statistically significant positive change indicative of study success."|Baseline and 6 weeks||||inches||Standard Deviation|Mean
2605471|NCT02109042|Primary|PK: Area Under the Concentration Curve of Blosozumab|The mean area under the concentration of Blosozumab versus time curve during 1 dosing interval was reported.|Predose and daily up through 7 days postdose|Participants who received at least 1 SC Blosozumab injection and had evaluable PK concentration data.|||picomoles times hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
2605472|NCT02109042|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab|The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported.|Predose and daily up through 7 days postdose|Participants who received at least 1 SC Blosozumab injection and had evaluable PK concentration data.|||picomoles per milliliter||Geometric Coefficient of Variation|Geometric Mean
2605473|NCT02109029|Primary|Part B: Pharmacokinetics: ISF-to-Serum Concentrations|Absolute concentration of ISF of insulin peglispro and human insulin.|16, 20, 24, and 28 hours postdose|All participants who received at least 1 dose of study drug in Part B and had evaluable pharmacokinetic data.|||picomol per liter (pmol/L)|||Number
2605474|NCT02109029|Primary|Part B: Pharmacokinetics: Steady-State Concentrations in Adipose Tissue Interstitial Fluid (ISF)||16, 20, 24, and 28 hours postdose|All participants who received at least 1 dose of study drug in Part B and had evaluable pharmacokinetic data.|||picomol per liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
2605475|NCT02108977|Primary|Cost Analysis|Labor (including training) and non-labor (e.g., equipment cost) inputs required to provide counseling via telephone versus videoconferencing. Patient travels costs will be included via self-report.|Cost analysis will be conducted in months 10-12 of grant period (projected January 1-March 31, 2015)|Travel distance data not applicable to the Teleconferencing group.|||Loss of Productivity Cost in US Dollars||Inter-Quartile Range|Median
2605476|NCT02108977|Primary|Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by GENETIC COUNSELORS|Five counselors agreed to be interviewed. We asked them to discuss specific aspects of each modality including the ease of use, navigation, and adaptability of each modality, conveying and comprehending genetic and numeric information, and perceived advantages and disadvantages of each modality.|Within 4 weeks after study data collection was completed|A subsample of counselors in each modality was interviewed to qualitatively assess the satisfaction with the counseling they provided, and the benefits and limitations of the modality, whether it was by phone or video.|||Participants|||Count of Participants
2605477|NCT02108977|Primary|Qualitative Assessment of Genetic Counseling Experience, Barriers and Facilitators by PATIENTS|We asked the subjects to discuss specific aspects of each modality including the ease of use, navigation, and adaptability of each modality, conveying and comprehending genetic and numeric information, and perceived advantages and disadvantages of each modality.|Within six weeks of receiving genetic counseling|A subsample of patients in each modality was interviewed to qualitatively assess the satisfaction with the counseling they received, and the benefits and limitations of the modality, whether it was by phone or video.|||participants|||Number
2605478|NCT02108977|Primary|Satisfaction With Genetic Counseling Session Using the Genetic Counseling Satisfaction Scale|6-question Genetic Counseling Satisfaction Scale using 5-point Likert scale responses Strongly Disagree (1) to Strongly Agree (5)|Within two weeks of receiving genetic counseling||||points on a scale of 30 (most satisfied)||Standard Deviation|Mean
2605479|NCT02108977|Primary|Assessment of Knowledge Retention of Genetic Counseling Information Via 8-Question Pre- and Post-Counseling Assessment|Subjects will be asked 8 True/False genetics-related questions before and after counseling to assess improvement and retention of genetic counseling knowledge and information|Pre- and post- (within 2 weeks) genetic counseling||||Number of correct answers (out of 8)||Standard Deviation|Mean
2605490|NCT02108951|Primary|Duration of Prior TKI Therapy for Patients Based on MR4.5 Achievement Status Within 24 Months|"Breakpoint cluster region - Abelson murine leukemia (BCR-ABL) levels are measured in patients by real-time quantitative polymerase chain reaction (RQ-PCR) testing of peripheral blood by the 24 months following the commencement of nilotinib therapy.~Deep molecular response (MR4.5) rate was defined as the percentage of patients who have achieved a 4.5-log reduction (MR4.5) in BCR-ABL levels during the 24 months following the commencement of nilotinib therapy. MR4.5 corresponds to a BCR-ABL ratio 0.0032% IS using RQ-PCR. If a post-baseline value for BCR-ABL is < 0.1 X the baseline value, the patient were classified as achieving a 1 log reduction in BCR-ABL."|Baseline, 96 weeks (24 months)|The full analysis set (FAS) consists of all patients enrolled into the study.|||months||Standard Deviation|Mean
2605581|NCT02108171|Other Pre-specified|Satisfaction Scores of Patients Receiving Intranasal Dexmedetomidine|Satisfaction scores of patients receiving intranasal dexmedetomidine. Satisfaction used a 3-point satisfaction score(1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable).|1 day||||units on a scale|||Number
2605480|NCT02108951|Secondary|Mean M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML)|"Quality of life was assessed using the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) self-administered questionnaire for adult CML patients. The questionnaire consisted of 13 core questions in part I measuring the severity of symptoms, 6 questions in part 2 assessing the interference of symptoms on daily living. The CML component of the MDASI provided an additional 7 CML-specific symptom items: diarrhea, swelling, rash/skin change, muscle soreness/cramping, bruising/bleeding easily, malaise, and headache. In part I (13 questions) and the CML component (7 questions) each question was scored from 0 to 10 where 0 indicates a symptom is not present and 10 indicate the symptom is as bad as you can imagine. For part 1 the total score can therefore range from 0 to 130 and for CML 0 to 70. Part 2 is also recorded on a 0 to 10 scale, but 0 now indicates that the symptom did not interfere and 10 interfered completely. The total score can range from 0 to 60."|Baseline, week 12, 24, 48, 96|The full analysis set (FAS) consists of all patients enrolled into the study. 'n' in the categories represents the number of patients with evaluable data for MDASI part 1/MDASI part 2/CML component at different time points. Week 96 includes end of study results for patients that did not complete the study.|||units on a scale||Standard Deviation|Mean
2605481|NCT02108951|Secondary|Number of Patients With Events Reported at Baseline That Have Shown an Improvement in Non-hematological AE Severity Compared to Week 12 Visit|The total number of patients that have showed improvement with respect to CTCAE grades at the time of the 12-week visit are reported. Improved is defined as prior to, or at the time of the 12-week visit, the AE has completely resolved.|Baseline, week 12 (month 3)|The Safety Set (SS) consisted of all patients in the FAS who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.|||Participants|||Count of Participants
2605482|NCT02108951|Secondary|Time to Event Free Survival (EFS)|"EFS was defined as the time from date of baseline visit to the first occurrence of any of the following: Disease progression, treatment failure or death from any cause, whichever was earlier. Patients who did not have an event of interest were censored at earliest of the following:~the date of the 24-month visit;~the date of loss to follow-up;~the date of withdrawal from the study for any reason other than lack of efficacy/progressive disease, tolerance to reduced dose or death"|96 weeks (24 months)|There were no patients in the study who were recorded as experiencing treatment failure.||||||
2605483|NCT02108951|Secondary|Time to Progression-free Survival (PFS)|"PFS was defined as the time from the date of baseline visit to the date of earliest progression-defining event: namely progression (or withdrawal due to progression to blast crisis (BC) or accelerated phase (AP) disease), or death from any cause.~Patients who did not progress were censored at earliest of the following:~the date of the 24-month visit;~the date of loss to follow-up;~the date of discontinuation of study treatment for any reason other than progression to BC, or AP disease, or death"|96 weeks (24 months)|The FAS consists of all patients enrolled into the study. There were no withdrawals due to progression to BC or AP disease, and there were no recorded deaths during the study.||||||
2605484|NCT02108951|Secondary|Kaplan-Meier Estimates of Time to Deep Molecular Response (MR4.5)|"Breakpoint cluster region - Abelson murine leukemia (BCR-ABL) levels is measured in patients by real-time quantitative polymerase chain reaction (RQ-PCR) testing of peripheral blood by the 24 months following the commencement of nilotinib therapy. MR4.5 corresponds to a~BCR-ABL ratio 0.0032% IS using RQ-PCR. The derivation of time to molecular response for patients in the study was measured from the date of first nilotinib use, defined as follows:~Days to MR4.5 = date of assessment where BCR-ABL ratio is 0.0032% IS - date of baseline + 1."|96 weeks (24 months)|The full analysis set (FAS) consists of all patients enrolled into the study. N represents all patients in FAS who achieved MR4.5.|||days||95% Confidence Interval|Median
2605485|NCT02108951|Secondary|Kinetics of Molecular Response: Percentage of Patients With MR4.5 Based on BCR-ABL Over Time After the Switch to Nilotinib|MR4.5 corresponds to a BCR-ABL ratio 0.0032% international scale (IS) using Real-time quantitative polymerase chain reaction (RQ-PCR).|Baseline, week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96|Full analysis set. n = number of patients with evaluable data at the defined time point|||percentage of patients|||Number
2605486|NCT02108951|Secondary|Kinetics of Molecular Response: Percentage of Patients With MR4.0 Based on BCR-ABL Over Time After the Switch to Nilotinib|MR4.0 corresponds to a BCR-ABL ratio 0.01% international scale (IS) using Real-time quantitative polymerase chain reaction (RQ-PCR).|Baseline, week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96|Full analysis set|||percentage of patients|||Number
2605487|NCT02108951|Secondary|Kinetics of Molecular Response: Percentage of Patients With MMR Based on BCR-ABL Over Time After the Switch to Nilotinib|MMR corresponds to a BCR-ABL ratio 0.1% international scale (IS) using Real-time quantitative polymerase chain reaction (RQ-PCR).|Baseline, week 4, 8, 12, 24, 36, 48, 60, 72 and 96|Full analysis set. n = number of patients with evaluable data at the defined time point|||percentage of patients|||Number
2605488|NCT02108951|Secondary|Kinetics of Molecular Response: Percentage of Patients With no Response Based on BCR-ABL Over Time After the Switch to Nilotinib|No response corresponds to a BCR-ABL ratio < 0.1% international scale (IS) using Real-time quantitative polymerase chain reaction (RQ-PCR).|Baseline, week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96|Full analysis set. n = number of patients with evaluable data at the defined time point|||percentage of patients|||Number
2605489|NCT02108951|Primary|Number of Patients With MR4.5 Response by Baseline BCR-ABL Response Level Within 24 Months|"Deep Molecular Response (MR4.5) rate is defined as the percentage of patients who have achieved a 4.5 -log reduction in Breakpoint cluster region - Abelson murine leukemia (BCR-ABL) levels. BCR-ABL levels are measured in patients by real-time quantitative polymerase chain reaction (RQ-PCR) testing of peripheral blood by the 24 months following the commencement of nilotinib therapy.~MR4.5 corresponds to a BCR-ABL ratio 0.0032% international scale (IS) using RQ-PCR. If a post-baseline value for BCR-ABL is < 0.1 X the baseline value, the patient were classified as achieving a 1 log reduction in BCR-ABL."|Baseline, 96 weeks (24 months)|The full analysis set (FAS) consists of all patients enrolled into the study. 'n' in categories indicates patients achieved or did not achieve MR4.5 during 24 months|||Participants|||Count of Participants
2605505|NCT02108652|Secondary|Minimum Serum Concentration (Cmin) of Atezolizumab||Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (Cycle length = 21 days)|Cohort 2 PK evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. “n” = participants who were evaluable at specified timepoint.|||mcg/mL||Standard Deviation|Mean
2605491|NCT02108951|Primary|Major Molecular Response (MMR) Rate: Percentage of Patients Who Have Achieved a 3 Log Reduction in BCR-ABL Levels Within 12 Months and 24 Months|Major Molecular Response (MMR) rate is defined as the percentage of patients who have achieved a 3 log reduction in BCR-ABL levels at 12 months and at 24 months following the commencement of nilotinib therapy. Breakpoint cluster region - Abelson murine leukemia (BCR-ABL) levels are measured in patients by real-time quantitative polymerase chain reaction (RQ-PCR) testing of peripheral blood at the 12 and 24 months following the commencement of nilotinib therapy. MMR corresponds to a BCR-ABL ratio 0.1% international scale (IS) using RQ-PCR. If a post-baseline value for BCR-ABL is < 0.1 * the baseline Value, the patient will be classified as achieving a 1 log drop.|Baseline, 48 weeks (12 months), 96 weeks (24 months)|The full analysis set (FAS) consists of all patients enrolled into the study.Analysis of MMR was undertaken on the subgroup of the FAS that was not at MMR at baseline.|||Percentage of participants||95% Confidence Interval|Number
2605492|NCT02108951|Primary|Molecular Response (MR4.0) Rate: Percentage of Patients Who Have Achieved a 4.0-log Reduction in BCR-ABL Level Within 12 Months and 24 Months|"Molecular Response (MR4.0) rate is defined as the percentage of patients who have achieved a 4-log reduction in BCR-ABL levels at 12 months and 24 months following the commencement of nilotinib therapy. Breakpoint cluster region - Abelson murine leukemia (BCR-ABL) levels are measured in patients by real-time quantitative polymerase chain reaction (RQ-PCR) testing of peripheral blood by the 24 months following the commencement of nilotinib therapy.~MR4.0 corresponds to a BCR-ABL ratio 0.01% international scale (IS) using RQ-PCR. If a post-baseline value for BCR-ABL is < 0.1 X the baseline value, the patients were classified as achieving a 1 log reduction in BCR-ABL."|Baseline, 48 weeks (12 months), 96 weeks (24 months)|The full analysis set (FAS) consists of all patients enrolled into the study. Analysis of MR4.0 was undertaken on the subgroup of the FAS that was not at MR4.0 at baseline.|||Percentage of participants||95% Confidence Interval|Number
2605493|NCT02108951|Primary|Deep Molecular Response (MR4.5) Rate: Percentage of Patients Who Have Achieved a 4.5-log Reduction in BCR-ABL Level Within 24 Month|"Deep Molecular Response (MR4.5) rate is defined as the percentage of patients who have achieved a 4.5 -log reduction in Breakpoint cluster region - Abelson murine leukemia (BCR-ABL) levels. BCR-ABL levels are measured in patients by real-time quantitative polymerase chain reaction (RQ-PCR) testing of peripheral blood by the 24 months following the commencement of nilotinib therapy.~MR4.5 corresponds to a BCR-ABL ratio 0.0032% international scale (IS) using RQ-PCR. If a post-baseline value for BCR-ABL is < 0.1 X the baseline value, the patient were classified as achieving a 1 log reduction in BCR-ABL."|Baseline, 96 weeks (24 months)|The full analysis set (FAS) consists of all patients enrolled into the study.|||Percentage of participants||95% Confidence Interval|Number
2605494|NCT02108912|Other Pre-specified|Temporal Spatial Gait Analysis|Testing will be completed using a 14'x4', 16-level pressure sensing Zeno Walkway. This system utilizes a computerized gait system for data collection. Gait parameters that will be collected include center of pressure, center of mass, step/stride length, velocity, toe in/out, cadence, and left/right lower extremity ratios. Participants will be asked to walk at self-selected and safe fast walking paces for repeated straight direction walking trials to collect an average of 100 feet of straight distance. This testing will be done at T1, T2, T3 and T4. This test takes 15 minutes to complete.|At enrollment, week 9, week 17 and week 25.|||||||
2605495|NCT02108912|Primary|Change in 6-Minute Walk Test Distance|Each subject will be asked to complete a 6-Minute Walk test. They will be advised to walk at a pace they think they can maintain for the entire time. Resting is permitted provided they are not required to sit. Participants will not be given any verbal encouragement during the test. A stop watch will be used to time the test and the distance will be measured with a calibrated measuring wheel along a 150 foot corridor. Heart rate will be monitored during the test by means of a Polar chest strap and values will be recorded at each minute of the test. Perceived rate of exertion using the Borg scale of 6-20 will be recorded at rest and each minute of the test.34 Blood pressure using an automated arm cuff will be recorded before and after the test.|At enrollment and week 25.|The Borg and blood pressure measures were used to monitor the response of the participants to the activity. If the blood pressure rose too high, for example, testing was terminated. Likewise, if the Borg rating was too high, participants were allowed to rest and vital signs were assessed again.|||feet||Full Range|Mean
2605496|NCT02108912|Primary|Maximum Exercise Tolerance Testing|Exercise tests will be performed with a treadmill with a static/dynamic body weight system. Measurements will be conducted with open circuit spirometry. Heart rate will be continuously monitored by electrocardiogram. Blood pressure will be monitored every 2 minutes. Participants will be allowed a 3-minute warm-up. Following the warm-up, participants will be allowed up to 10 minutes to rest or until they recovery to baseline heart rate, respiration rate and blood pressure.|Change in exercise tolerance from enrollment to 9 weeks later and 25 weeks later|The data was corrupted and unable to be analyzed.||||||
2605497|NCT02108691|Secondary|Changes in LDLc/HDLc|LDLc/HDLc was measured in study visit 1(0week) and visit 3(8 week).|8 weeks||||ratio||Standard Deviation|Mean
2605498|NCT02108691|Secondary|Changes in Non-HDLc|Non-HDLc was measured in study visit 1(0week) and visit 3(8 week).|8 weeks||||mg/dl||Standard Deviation|Mean
2605499|NCT02108691|Secondary|Changes in LDLc|LDLc was measured in study visit 1(0week) and visit 3(8 week).|8 weeks||||mg/dl||Standard Deviation|Mean
2605500|NCT02108691|Secondary|Changes in BMI(Body Mass Index)|BMI(body mass index) was measured in study visit 1(0week) and visit 3(8 week).|8 weeks||||kg/m^2||Standard Deviation|Mean
2605501|NCT02108691|Secondary|Changes in Weight|Weight was measured in study visit 1(0 week)and visit 3(8 week).|8 weeks||||kg||Standard Deviation|Mean
2605502|NCT02108691|Secondary|Changes in Percent Body Fat|Percent Body Fat was measured in study visit 1(0 week) and visit 3(8 week).|8 weeks||||percentage||Standard Deviation|Mean
2605503|NCT02108691|Primary|Changes in Body Fat Mass|Body Fat Mass was measured in study visit 1(0 week) and visit 3(8 week).|8 weeks||||g||Standard Deviation|Mean
2605504|NCT02108652|Secondary|Percentage of Participants Positive for Anti-therapeutic Antibodies (ATA) to Atezolizumab||Day 1 of all cycles (Cycle length = 21 days) and at treatment discontinuation (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 Safety Evaluable Population. Here, number of participants analyzed = participants for whom ATA samples were available.|||percentage of participants|||Number
2605527|NCT02108223|Secondary|Implantation Rates|Implantation rate is the percentage of embryos which successfully undergo implantation|up to 9 months||||percentage of embryo implantation|||Number
2605506|NCT02108652|Secondary|Maximum Serum Concentration (Cmax) of Atezolizumab||Pre-dose (0 hours) and 30 minutes post-dose on Day 1 of Cycle 1 (Cycle length = 21 days)|Cohort 2 pharmacokinetic (PK) evaluable population was defined as participants who received any dose of atezolizumab treatment and had PK data at timepoints that were sufficient to determine PK parameters. Here, number of participants analyzed = participants who were evaluable for this outcome.|||microgram(s)/milliliter (mcg/mL)||Standard Deviation|Mean
2605507|NCT02108652|Secondary|Percentage of Participants Alive at 1-year||1-year|Cohort 2 ITT Population|||percentage of participants||95% Confidence Interval|Number
2605508|NCT02108652|Secondary|Overall Survival (OS)|OS was defined as the time from start of treatment to the time of death from any cause on study.|Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population|||months||95% Confidence Interval|Median
2605509|NCT02108652|Secondary|Percentage of Participants Who Died|The percentage of participants who died from any cause was reported.|Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population|||percentage of participants|||Number
2605510|NCT02108652|Secondary|Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 objective response-evaluable population.|||percentage of participants||95% Confidence Interval|Number
2605511|NCT02108652|Secondary|PFS as Assessed by the Investigator According to Modified RECIST|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to modified RECIST. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population|||months||95% Confidence Interval|Median
2605512|NCT02108652|Secondary|Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to Modified RECIST|Tumor response was assessed by the investigator according to modified RECIST. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population|||percentage of participants|||Number
2605513|NCT02108652|Secondary|PFS as Assessed by the Investigator According to RECIST v1.1|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population|||months||95% Confidence Interval|Median
2605514|NCT02108652|Secondary|Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population|||percentage of participants|||Number
2605515|NCT02108652|Secondary|Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population|||months||95% Confidence Interval|Median
2605516|NCT02108652|Secondary|Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1|Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 ITT population|||percentage of participants|||Number
2605528|NCT02108223|Secondary|Fertilization Rate|fertilization rate used to measure how many oocytes become fertilized by sperm cells|up to 9 month||||percentage of fertilized oocytes|||Number
2605517|NCT02108652|Secondary|DOR as Assessed by the Investigator According to Modified RECIST|DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to modified RECIST. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||months||Full Range|Median
2605518|NCT02108652|Secondary|DOR as Assessed by the Investigator According to RECIST v1.1|DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||months||Full Range|Median
2605519|NCT02108652|Secondary|Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1|DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||months||Full Range|Median
2605520|NCT02108652|Primary|Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According Modified RECIST|Tumor response was assessed by the investigator according to modified RECIST. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 objective response-evaluable population.|||percentage of participants||95% Confidence Interval|Number
2605521|NCT02108652|Primary|Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% confidence interval (CI) was calculated using the Clopper-Pearson method.|Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 24.48 months)|Cohort 2 objective response-evaluable population included Intent-to-treat (ITT) participants who had measurable disease per RECIST v1.1 at baseline. Cohort 2 ITT population included all participants from Cohort 2 who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
2605522|NCT02108457|Primary|Number of Participants With Adverse Events||up to 5 weeks||||Participants|||Count of Participants
2605523|NCT02108288|Secondary|Tmax of Latanoprost Acid||Day 1 and Day 7||||min||Full Range|Median
2605524|NCT02108288|Secondary|Tmax of Carteolol||Day 1 and Day 7||||h||Full Range|Median
2605525|NCT02108288|Primary|Cmax of Latanoprost Acid||Day 1 and Day 7||||pg/mL||Standard Deviation|Mean
2605526|NCT02108288|Primary|Cmax of Carteolol||Day 1 and Day 7||||ng/mL||Standard Deviation|Mean
2605531|NCT02108223|Primary|Pregnancy Rate|percentage of participants with a pregnancy (a b-HCG determination was obtained and considered positive if the value was greater than 10 mIU/ml)|Up to 9 month|In Group 1, transfer procedure could not be performed one patient. In Group 2, the cycle was cancelled in two patients. Oocyte could not be obtained in one patient during OPU. In other 2 patients, transfer couldn’t be done. In Group 3 transfer procedure could not be performed in one patient. The pregnancy rates per embryo transfer were calculated.|||percentage of pregnant participants|||Number
2605532|NCT02108171|Secondary|Perioperative Hypertonsion Episodes|Hypertension was defined as systolic blood pressure (SBP) increased 130% of the pre-operative value for more than 1 min.|1 day||||participant|||Number
2605533|NCT02108171|Secondary|Perioperative Hypotension Episodes|Hypotension was defined as systolic blood pressure (SBP) decreased more than 30% of the pre-operative value for more than 1 min.|1 day||||participant|||Number
2605534|NCT02108171|Secondary|Perioperative Tachycardia Episodes|Tachycardia was defined as heart rate (HR) >100 bpm for more than 10 s.|1 day||||participant|||Number
2605535|NCT02108171|Secondary|Perioperative Bradycardia Episodes|Bradycardia was defined as heart rate (HR) <45 bpm for more than 10 s.|1 day||||participant|||Number
2605536|NCT02108171|Secondary|Number of Participants With Satisfaction Score <2|"Patient satisfaction scores using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) were collected when patients were discharged from the post-anesthesia care unit (PACU).~Satisfaction score <2 was considered to be better for the patient"|1 day||||participant|||Number
2605537|NCT02108171|Secondary|Systolic Blood Pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine|Systolic blood pressure（SBP）of Patients Receiving Intranasal Placebo or Dexmedetomidine.|1 day||||mmHg||Standard Deviation|Mean
2605538|NCT02108171|Secondary|Anxiety Score of Patients Receiving Intranasal Placebo or Dexmedetomidine|"4-point anxiety score:~= combative~= anxious~= calm~= amiable. Anxiety score >2 was considered to be better for the preoperative patients."|1 day||||units on a scale||Inter-Quartile Range|Median
2605539|NCT02108171|Other Pre-specified|Visual Analogue Scale (VAS) in the Dexmedetomidine (DEX) Group|An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.|1 day||||units on a scale|||Number
2605540|NCT02108171|Other Pre-specified|Visual Analogue Scale (VAS) in the Placebo Group|An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.|1 day||||units on a scale|||Number
2605541|NCT02108171|Other Pre-specified|Patients With Intra-operative Awareness in Two Groups|Patients With intra-operative awareness in Two Groups. patients receiving intranasal placebo or dexmedetomidine|1 day||||participants|||Number
2605542|NCT02108171|Other Pre-specified|Patients With Postoperative Shivering in Two Groups|Patients With postoperative shivering in Two Groups. the occurrence of postoperative shivering|1 day||||participants|||Number
2605543|NCT02108171|Other Pre-specified|Patients With Postoperative Vomiting in Two Groups|Patients With postoperative vomiting in Two Groups. Nausea or vomiting was treated with 4 mg of intravenous ondansetron.|1 day||||participants|||Number
2605544|NCT02108171|Other Pre-specified|Patients With Postoperative Nausea in Two Groups|Patients With postoperative nausea in Two Groups. Nausea or vomiting was treated with 4 mg of intravenous ondansetron.|1 day||||participants|||Number
2605545|NCT02108171|Other Pre-specified|Number of Participants With VAS >50|Patients with postoperative analgesia in two groups. analgesic requests within 2 h after extubation were recorded. An investigator who was blinded from the grouping asked the patients to mark their pain level on a 0-100 visual analogue scale (VAS). A VAS higher than 50 was considered a worse outcome and need to be treated with intravenous 40 mg of parecoxib.|1 day||||Number of Participants with VAS >50|||Number
2605546|NCT02108171|Other Pre-specified|HR in the Dexmedetomidine Group at Pre-induction|HR in the dexmedetomidine group at pre-induction. HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room|1 day||||bpm|||Number
2605547|NCT02108171|Other Pre-specified|HR in the Placebo Group at Pre-induction|HR in the placebo group at pre-induction. HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room|1 day||||bpm|||Number
2605548|NCT02108171|Other Pre-specified|HR in the Dexmedetomidine Group Before Intranasal Drugs|HR in the dexmedetomidine group Before Intranasal Drugs . HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room|1 day||||bpm|||Number
2605549|NCT02108171|Other Pre-specified|HR in the Placebo Group Before Intranasal Drugs|HR in the placebo group Before Intranasal Drugs HR was monitored by fiber-optic pulse oximetry during patient transfer from the ward to the operating room|1 day||||bpm|||Number
2605550|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Extubation|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at extubation.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
2605551|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Extubation|"Predicted effect-site concentrations of remifentanil after intranasal placebo at extubation.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
2605582|NCT02108171|Other Pre-specified|Satisfaction Scores of Patients Receiving Intranasal Placebo|Satisfaction scores of patients receiving intranasal placebo. satisfaction was assessed using a 3-point satisfaction score(1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable).|1 day||||units on a scale|||Number
2605552|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Emergence|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at emergence.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
2605553|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Emergence|"Predicted effect-site concentrations of remifentanil after intranasal placebo at emergence.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
2605554|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Return of Spontaneous Breathing|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at return of spontaneous breathing.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
2605555|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Return of Spontaneous Breathing|"Predicted effect-site concentrations of remifentanil after intranasal placebo at return of spontaneous breathing.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
2605556|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine on Removal of Operative Laryngoscope|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine on removal of operative laryngoscope.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
2605557|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo on Removal of Operative Laryngoscope|"Predicted effect-site concentrations of remifentanil after intranasal placebo on removal of operative laryngoscope.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
2605558|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine Before Inserting Operative Laryngoscope|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine before inserting operative laryngoscope.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
2605559|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo Before Inserting Operative Laryngoscope|"Predicted effect-site concentrations of remifentanil after intranasal placebo before inserting operative laryngoscope.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
2605560|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Dexmedetomidine at Tracheal Intubation|"Predicted effect-site concentrations of remifentanil after intranasal dexmedetomidine at tracheal intubation.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
2605561|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Remifentanil After Intranasal Placebo at Tracheal Intubation|"Predicted effect-site concentrations of remifentanil after intranasal placebo at tracheal intubation.~Remifentanil was infused to achieve a TCI plasma concentration of 3.0 ng∙ml-1 using the Minto pharmacokinetic model 24 and then adjusted to maintain the systolic blood pressure (SBP) at 25% of the pre-operative value and the HR at less than 90 bpm. To maintain a neuromuscular blockade, 0.15 mg∙kg-1 increments of rocuronium were infused upon observation of the first twitch in a train-of-four response with the nerve stimulator"|1 day||||ng/ml|||Number
2605580|NCT02108171|Secondary|Number of Participants With Anxiety Score >2|"satisfaction using a 3-point satisfaction score (1 = highly satisfactory, 2 = acceptable, and 3 = unacceptable) anxiety levels using a 4-point anxiety score (1 = combative, 2 = anxious, 3 = calm, and 4 = amiable) were collected before intranasal drugs and at pre-induction.~Anxiety score >2 was considered to be better for the patient."|1 day||||participant|||Number
2605562|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Extubation|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at extubation.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
2605563|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Extubation|"Predicted effect-site concentrations of propofol after intranasal placebo at extubation.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
2605564|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Emergence|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at emergence.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
2605565|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Emergence|"Predicted effect-site concentrations of propofol after intranasal placebo at emergence.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
2605566|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Return of Spontaneous Breathing|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at return of spontaneous breathing.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
2605567|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Return of Spontaneous Breathing|"Predicted effect-site concentrations of propofol after intranasal placebo at return of spontaneous breathing.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||ug/ml|||Number
2605568|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine on Removal of Operative Laryngoscope|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine on removal of operative laryngoscope.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
2605569|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo on Removal of Operative Laryngoscope|"Predicted effect-site concentrations of propofol after intranasal placebo on removal of operative laryngoscope.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
2605570|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine Before Inserting Operative Laryngoscope|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine before inserting operative laryngoscope.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
2605571|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo Before Inserting Operative Laryngoscope|"Predicted effect-site concentrations of propofol after intranasal placebo before inserting operative laryngoscope.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
2605572|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Dexmedetomidine at Tracheal Intubation|"Predicted effect-site concentrations of propofol after intranasal dexmedetomidine at tracheal intubation.~Propofol was infused intraoperatively to a TCI plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
2605573|NCT02108171|Other Pre-specified|Predicted Effect-site Concentrations of Propofol After Intranasal Placebo at Tracheal Intubation|"Predicted effect-site concentrations of propofol after intranasal placebo at tracheal intubation.~Propofol was infused intraoperatively to a target-controlled infusion (TCI) plasma concentration of 2.5μg∙ml-1 using DiprifusorTM software. The infusion rate was adjusted via plasma concentration increments of 0.5 μg∙ml-1 at 2-min intervals to maintain the Narcotrend index between 'D0' and 'E1' until the end of surgery."|1 day||||µg/ml|||Number
2605574|NCT02108171|Other Pre-specified|Time to Extubation of Patients Receiving Intranasal Dexmedetomidine|Time to extubation of patients receiving intranasal dexmedetomidine. The time elapsed between stopping anesthetic infusions and extubation|1 day||||minutes|||Number
2605575|NCT02108171|Other Pre-specified|Time to Extubation of Patients Receiving Intranasal Placebo|Time to extubation of patients receiving intranasal placebo. The time elapsed between stopping anesthetic infusions and extubation|1 day||||minutes|||Number
2605583|NCT02108171|Other Pre-specified|Anxiety Score of Patients Receiving Intranasal Dexmedetomidine at Pre-induction|"Anxiety score of Patients Receiving Intranasal dexmedetomidine at Pre-induction.~The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)"|1 day||||units on a scale|||Number
2605584|NCT02108171|Other Pre-specified|Anxiety Score of Patients Receiving Intranasal Placebo at Pre-induction|Anxiety score of Patients Receiving Intranasal Placebo at Pre-induction. The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)|1 day||||units on a scale|||Number
2605585|NCT02108171|Other Pre-specified|Anxiety Score of Patients Receiving Intranasal Dexmedetomidine Before Intranasal Drugs|"Anxiety score of Patients Receiving Intranasal dexmedetomidine Before Intranasal Drugs.~The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)"|1 day||||units on a scale|||Number
2605586|NCT02108171|Other Pre-specified|Anxiety Score of Patients Receiving Intranasal Placebo Before Intranasal Drugs|Anxiety score of Patients Receiving Intranasal Placebo Before Intranasal Drugs. The patients were taught to rate their anxiety levels using a 4-point anxiety score (1 = combative, 2 =anxious, 3 = calm, and 4 = amiable)|1 day||||units on a scale|||Number
2605587|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine After Extubation|"Modified OAA/S score of patients receiving intranasal dexmedetomidine after extubation.~Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score):~6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day||||units on a scale|||Number
2605588|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Placebo After Extubation|"Modified OAA/S score of patients receiving intranasal placebo After extubation. Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day||||units on a scale|||Number
2605589|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine at Pre-induction|"Modified OAA/S score of patients receiving intranasal dexmedetomidine at Pre-induction.~Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score):~6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day||||units on a scale|||Number
2605590|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Placebo at Pre-induction|"Modified OAA/S score of patients receiving intranasal placebo at Pre-induction.~Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score):~6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day||||units on a scale|||Number
2605591|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Dexmedetomidine Before Intranasal Drugs|"Modified OAA/S score of patients receiving intranasal dexmedetomidine Before intranasal drugs Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day||||units on a scale|||Number
2605592|NCT02108171|Other Pre-specified|Modified OAA/S Score of Patients Receiving Intranasal Placebo Before Intranasal Drugs|"Modified OAA/S score of patients receiving intranasal placebo Before intranasal drugs Modified Observer's Assessment of Alertness/Sedation Scale (Modified OAA/S score) 6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus"|1 day||||units on a scale|||Number
2605593|NCT02108171|Other Pre-specified|Duration of Surgery of Patients Receiving Intranasal Dexmedetomidine|Duration of surgery of patients receiving intranasal dexmedetomidine. Duration from surgery beginning to anesthesia ending|1 day||||minutes|||Number
2605594|NCT02108171|Other Pre-specified|Duration of Surgery of Patients Receiving Intranasal Placebo|Duration of surgery of patients receiving intranasal placebo Duration from surgery beginning to anesthesia ending|1 day||||minutes|||Number
2605595|NCT02108171|Other Pre-specified|Duration of Anesthesia of Patients Receiving Intranasal Dexmedetomidine|Duration of anesthesia of patients receiving intranasal dexmedetomidine Duration from anesthesia intubation to anesthesia ending|1 day||||minutes|||Number
2605596|NCT02108171|Other Pre-specified|Duration of Anesthesia of Patients Receiving Intranasal Placebo|Duration of anesthesia of patients receiving intranasal placebo Duration from anesthesia intubation to anesthesia ending|1 day||||minutes|||Number
2605597|NCT02108171|Other Pre-specified|Duration From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal Dexmedetomidine|Duration of minutes From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal dexmedetomidine surgical data of Patients Receiving Intranasal dexmedetomidine.|1 day||||minutes|||Number
2605598|NCT02108171|Other Pre-specified|Duration From Intranasal Drug Administration to Anesthesia Intubation of Patients Receiving Intranasal Placebo|Duration from intranasal drug administration to anesthesia intubation of Patients Receiving Intranasal Placebo surgical data of patients receiving intranasal placebo|1 day||||minutes|||Number
2605599|NCT02108171|Other Pre-specified|Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal Dexmedetomidine|Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal dexmedetomidine surgical data of patients receiving intranasal dexmedetomidine|1 day||||minutes|||Number
2605600|NCT02108171|Other Pre-specified|Duration From Intranasal Drug Administration to Arrival at Operating Room of Patients Receiving Intranasal Placebo|Duration from intranasal drug administration to arrival at operating room of patients receiving intranasal placebo surgical data of patients receiving intranasal placebo|1 day||||minutes|||Number
2605601|NCT02108171|Other Pre-specified|Baseline Characteristics (ASA Status) of Patients Receiving Intranasal Placebo or Dexmedetomidine|"American Society of Anesthesiologists (ASA) status of patients receiving intranasal placebo or dexmedetomidine.~ASA I: No organic, physiologic, biochemical or psychiatric disturbance ASA II: A patient with mild systemic disease that results in no functional limitation.~ASA III: A patient with severe systemic disease that results in functional impairment.~ASA IV: Severe systemic disease that is a constant threat to life. ASA V: Moribund condition in a patient who is not expected to survive with or without the operation.~ASA VI: Declared brain death patient whose organs are being harvested for transplantation."|1 day||||participant|||Number
2605602|NCT02108171|Other Pre-specified|Baseline Characteristics (Sex)of Patients Receiving Intranasal Placebo or Dexmedetomidine|Baseline characteristics (sex)of patients receiving intranasal placebo or dexmedetomidine The sex of 81 adult patients receiving intranasal placebo or dexmedetomidine|1 day||||participants|||Number
2605603|NCT02108171|Other Pre-specified|Baseline Characteristic Data (Height) of Patients Receiving Intranasal Dexmedetomidine|Baseline characteristic data of patients receiving intranasal dexmedetomidine The heights of 40 adult patients receiving intranasal placebo|1 day||||cm|||Number
2605604|NCT02108171|Other Pre-specified|Baseline Characteristic Data (Height) of Patients Receiving Intranasal Placebo|Baseline characteristic data of patients receiving intranasal placebo The heights of 41 adult patients receiving intranasal placebo|1 day||||cm|||Number
2605605|NCT02108171|Other Pre-specified|Baseline Characteristic Data (Weight) of Patients Receiving Intranasal Dexmedetomidine|Baseline characteristic data of patients receiving intranasal dexmedetomidine The weights of 40 adult patients receiving intranasal dexmedetomidine|1 day||||kg|||Number
2605606|NCT02108171|Other Pre-specified|Baseline Characteristic Data (Weight) of Patients Receiving Intranasal Placebo|Baseline characteristic data of patients receiving intranasal placebo The weights of 41 adult patients receiving intranasal placebo|1 day||||kg|||Number
2605607|NCT02108171|Secondary|Heart Rate (HR) of Patients Receiving Intranasal Placebo or Dexmedetomidine|Heart rate (HR) of patients receiving intranasal placebo or dexmedetomidine. HR was monitored in the study.|1 day||||bpm||Standard Deviation|Mean
2605608|NCT02108171|Secondary|Modified OAA/S Scores of Patients Receiving Intranasal Placebo or Dexmedetomidine|"Modified Observer's Assessment of Alertness/Sedation scale (OAA/S) scores and 4 point anxiety score of patients receiving intranasal placebo or dexmedetomidine.~Modified Observer's Assessment of Alertness/Sedation Scale:~6 Appears alert and awake, responds readily to name spoken in normal tone 5 Appears asleep but responds readily to name spoken in normal tone 4 Lethargic response to name spoken in normal tone 3 Responds only after name is called loudly or repeatedly 2 Responds only after mild prodding or shaking~1 Does not respond to mild prodding or shaking 0 Does not respond to noxious stimulus."|1 days||||units on a scale||Inter-Quartile Range|Median
2605609|NCT02108171|Primary|Extubation Time After Intranasal Dexmedetomidine Premedication|The times from stopping anesthetic infusions to adequate ventilation, consciousness and extubation after intranasal dexmedetomidine or placebo administration|1 days||||min||Standard Deviation|Mean
2605610|NCT02107898|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.|||Percent change||Standard Error|Least Squares Mean
2605611|NCT02107898|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||Percent change||Standard Error|Least Squares Mean
2605612|NCT02107898|Secondary|Percent Change From Baseline in Apo A1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo A1 ITT population.|||percent change||Standard Error|Least Squares Mean
2605613|NCT02107898|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2605614|NCT02107898|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2605615|NCT02107898|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2605616|NCT02107898|Secondary|Percent Change From Baseline in Apo A1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population).|||percent change||Standard Error|Least Squares Mean
2605659|NCT02107482|Secondary|The Percentage of Change in Target Lesion Score||12 weeks||||percentage of change in TLS||Standard Deviation|Mean
2605617|NCT02107898|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2605618|NCT02107898|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2605619|NCT02107898|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment were included in the imputation model.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2605620|NCT02107898|Secondary|Percentage of Participants Reaching Calculated LDL-C Goal at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|Up to Week 24|mITT population.|||percentage of participants|||Number
2605621|NCT02107898|Secondary|Percentage of Participants Reaching Calculated LDL-C Goal at Week 24 - ITT Analysis|"Calculated LDL-C goal was defined as:~<100 mg/dL (2.59 mmol/L) for heFH or non-FH participants who had a history of documented congestive heart disease (CHD), or~<120 mg/dL (3.10 mmol/L) for non-FH participants who had a history of documented diseases (ischemic stroke, peripheral artery disease, chronic kidney disease or diabetes) or other risk factors as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.~Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in imputation model."|Up to Week 24|ITT population.|||percentage of participants|||Number
2605622|NCT02107898|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
2605623|NCT02107898|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2605624|NCT02107898|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
2605625|NCT02107898|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).|||percent change||Standard Error|Least Squares Mean
2605626|NCT02107898|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).|||percent change||Standard Error|Least Squares Mean
2605627|NCT02107898|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2605628|NCT02107898|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|Participants of the mITT population with one baseline and at least one post-baseline Apo-B value on-treatment (Apo B mITT population).|||percent change||Standard Error|Least Squares Mean
2605629|NCT02107898|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).|||percent change||Standard Error|Least Squares Mean
2605630|NCT02107898|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.|||percent change||Standard Error|Least Squares Mean
2605631|NCT02107898|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
2605660|NCT02107482|Primary|The Percentage of Lesions With a Clear or Almost Clear Rating (Target Lesion Score of 3 or Less) on Target Lesion Scoring at Week 12||12 weeks||||percentage of lesions changed|||Number
2605632|NCT02107898|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2605633|NCT02107898|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis)|Adjusted least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2605634|NCT02107859|Other Pre-specified|Change From Baseline in Percent Predicted Forced Expiratory Flow Between 25% and 75% of Expiration (FEF25-75) at the End of Treatment (Week 192), as Assessed by Spirometry|FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity.|Baseline, Week 192|Due to change in planned analysis FEV25-75 was not calculated and summarized.||||||
2605635|NCT02107859|Other Pre-specified|Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at the End of Treatment (Week 192), as Assessed by Spirometry|FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Change from baseline in percent predicted FVC at the end of treatment was reported.|Baseline, Week 192|ITT population included all participants who had at least 1 post-baseline efficacy assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. 'Number analyzed' signifies participants evaluable at specified timepoint.|||percentage of predicted FVC||Standard Deviation|Mean
2605636|NCT02107859|Secondary|Change From Baseline in Vital Signs at Final Visit (Week 196)|Vital Signs included systolic blood pressure (SBP) and diastolic blood pressure (DBP).|Baseline, Week 196|As-treated population included all participants who received at least 1 dose of ataluren. Here, 'Number analyzed' signifies participants evaluable for specified categories.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2605637|NCT02107859|Secondary|Change From Baseline in Heart Rate at Final Visit (Week 196), as Assessed by 12-Lead ECG|Heart rate was measured using 12-lead ECG.|Baseline, Week 196|As-treated population included all participants who received at least 1 dose of ataluren. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. 'Number analyzed' signifies participants evaluable for specified categories.|||beats/minute||Standard Deviation|Mean
2605638|NCT02107859|Secondary|Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters at Final Visit (Week 196)|ECG parameters included RR duration, PR duration, QRS duration, QT duration, QTCB (Bazett's correction formula) duration, QTCF (Fridericia's correction formula) duration.|Baseline, Week 196|As-treated population included all participants who received at least 1 dose of ataluren. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. 'Number analyzed' signifies participants evaluable for specified categories.|||miiliseconds||Standard Deviation|Mean
2605639|NCT02107859|Secondary|Percentage of Participants With Pulmonary Exacerbation, As Assessed by Classic Fuchs' Criteria|The Classic Fuchs' criteria defined exacerbation as the presence of at least 4 of the following 12 Fuchs' signs and symptoms requiring treatment with parenteral antibiotics: change in sputum; new or increased hemoptysis; increased cough; increased dyspnea; fatigue; temperature >38°C; anorexia; sinus pain; change in sinus discharge; change in physical examination of the chest; decrease in pulmonary function by 10 percent or more from a previously recorded value; or radiographic changes indicative of pulmonary function.|Baseline up to Week 192|ITT population included all participants who had at least 1 post-baseline efficacy assessment.|||percentage of participants|||Number
2605640|NCT02107859|Secondary|Percentage of Participants With Pulmonary Exacerbation, As Assessed by Expanded Fuchs' Criteria|The expanded Fuchs' criteria defined exacerbation as the presence of at least 4 of the following 12 Fuchs' signs and symptoms requiring any form of antibiotic treatment (inhaled, oral, or intravenous): change in sputum; new or increased hemoptysis; increased cough; increased dyspnea; fatigue; temperature >38°C; anorexia; sinus pain; change in sinus discharge; change in physical examination of the chest; decrease in pulmonary function by 10 percent or more from a previously recorded value; or radiographic changes indicative of pulmonary function.|Baseline up to Week 192|ITT population included all participants who had at least 1 post-baseline efficacy assessment.|||percentage of participants|||Number
2605641|NCT02107859|Secondary|Percentage of Participants With Pulmonary Exacerbation, As Assessed by Modified Fuchs Criteria|The modified Fuchs' criteria defined exacerbation as the presence of at least 4 of the following 12 Fuchs' signs and symptoms without the requirement for treatment with antibiotics: change in sputum; new or increased hemoptysis; increased cough; increased dyspnea; fatigue; temperature greater than (>) 38 degrees celsius (°C); anorexia; sinus pain; change in sinus discharge; change in physical examination of the chest; decrease in pulmonary function by 10 percent or more from a previously recorded value; or radiographic changes indicative of pulmonary function.|Baseline up to Week 192|ITT population included all participants who had at least 1 post-baseline efficacy assessment.|||percentage of participants|||Number
2605642|NCT02107859|Secondary|Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at the End of Treatment (Week 192), as Assessed by Spirometry|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Percent of predicted FEV1 = (observed value)/(predicted value) * 100%. Change from baseline in percent predicted FEV1 at the end of treatment was reported.|Baseline, Week 192|ITT population included all participants who had at least 1 post-baseline efficacy assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure. 'Number analyzed' signifies participants evaluable at specified timepoint.|||percentage of predicted FEV1||Standard Deviation|Mean
2605672|NCT02107339|Secondary|Pain Scores Postoperative Day 3|11-point verbal rating scale (0=no pain, 10=worst pain imaginable)|Pain scores 72 hours after PACU admission||||units on a scale||Inter-Quartile Range|Median
2605710|NCT02107014|Primary|Change in VCAM-1 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2605643|NCT02107859|Primary|Number of Participants With Clinically Significant Laboratory Abnormalities|Laboratory parameters tests included hematology, biochemistry assay (hepatic, renal, and serum electrolyte values), adrenal assays, and urinalysis. Clinical significance was defined as per investigator's judgement.|Baseline (Day 1) up to end of study (Week 196)|As-treated population included all participants who received at least 1 dose of ataluren.|||Participants|||Count of Participants
2605644|NCT02107859|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of an AE was classified as: mild (does not interfere with usual function), moderate (interferes to some extent with usual function), severe (interferes significantly with usual function), life threatening (results in potential threat to life), and fatal AEs. Drug-related AEs: AEs with a possible or probable relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention. TEAE: AE that occurred or worsened from first dose of study drug to 4 weeks after last dose of study drug. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline (Day 1) up to end of study (Week 196)|As-treated population included all participants who received at least 1 dose of ataluren.|||Participants|||Count of Participants
2605645|NCT02107703|Secondary|Change From Baseline to Short Term Follow up in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire|EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms and arm symptoms. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment*Visit and baseline.|Baseline, Short Term Follow Up (Up To 31 Months)|All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-BR23 data at short term follow up for each BR23 items.|||Units on a scale||Standard Error|Least Squares Mean
2605646|NCT02107703|Secondary|Change From Baseline to Short Term Follow up in Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)|EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, scores range from 0 to 110 with higher scores representing a better level of functioning. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment*Visit and baseline.|Baseline, Short Term Follow Up (Up To 31 Months)|All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 data at short term follow up for each EORTC QLQ-C30 items.|||units on a scale||Standard Error|Least Squares Mean
2605647|NCT02107703|Secondary|Change From Baseline in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L)|European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The EQ-5D-5L is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. A higher score indicates better health state. LS Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.|Baseline, End of Study (Up To 31 Months)|All randomized participants who received at least one dose of study drug with baseline and post-baseline EQ-5D 5L data.|||mm||Standard Error|Least Squares Mean
2605648|NCT02107703|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Abemaciclib, Its Metabolites M2 and M20|Area Under the Plasma Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20.|Cycle 1 Day 1 2-4 hours (h) post dose, Cycle 1 Day 15 4 and 7h post dose, Cycle 2 Day 1 pre dose and 3h post dose, Cycle 3 Day1 pre dose|All randomized participants who received at least one dose of 150 mg study drug (Abemaciclib) with evaluable Abemaciclib, M2 and M20 PK data.|||Nanograms*hour/milliliters (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2605649|NCT02107703|Secondary|Change From Baseline in Pain and Symptom Burden Assessment Using the Modified Brief Pain Inventory-Short Form (mBPI-sf)|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. Least square (LS) Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.|Baseline, End of Study (Up To 31 Months)|All randomized participants who received at least one dose of study drug with a baseline and at least 1 post-baseline result.|||score on a scale||Standard Error|Least Squares Mean
2605650|NCT02107703|Secondary|Percentage of Participants With CR, PR or SD With a Duration of At Least 6 Months (Clinical Benefit Rate [CBR])|Clinical benefit rate defined as percentage of participants with best overall response of CR, PR, or SD with a duration of at least 6 months.CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants=(participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) *100.PD was at least a 20% increase in sum of the diameters of target lesions,with reference being the smallest sum on study and an absolute increase of at least 5 mm or unequivocal progression of non-target lesions,or 1 or more new lesions.|From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)|All randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2605651|NCT02107703|Secondary|Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])|Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.|From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)|All randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2605652|NCT02107703|Secondary|Duration of Response (DOR)|DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.|From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 31 Months)|All randomized participants with response.|||Months||95% Confidence Interval|Median
2605653|NCT02107703|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])|ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.|From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)|All randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2605654|NCT02107703|Secondary|Overall Survival (OS)|OS defined as the time from the date of randomization to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.|From Date of Randomization until Death Due to Any Cause (Up To 80 Months)|All randomized participants. Censored participants: Abemaciclib=361.|||Months||95% Confidence Interval|Median
2605655|NCT02107703|Primary|Progression-Free Survival (PFS)|PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.|From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months)|All randomized participants. Censored participants: Abemaciclib=224.|||Months||95% Confidence Interval|Median
2605656|NCT02107599|Secondary|Change in Scan Interpretation Reliability After Application of Quantitation Software|"Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values >0 indicate an improvement in scan interpretation accuracy and values <0 indicate a decline in scan interpretation accuracy after application of quantitation software.~NRI = [P(up,event)-P(down,event)]-[P(up,nonevent)-P(down,nonevent)] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative~Only the 46 scans with autopsy from A16 are used for this outcome measure."|Scan acquired 50-60 minutes post injection||||Fleiss Kappa||95% Confidence Interval|Number
2605657|NCT02107599|Primary|Change in Reader Accuracy After Application of Quantitation Software|"Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values >0 indicate an improvement in scan interpretation accuracy and values <0 indicate a decline in scan interpretation accuracy after application of quantitation software.~NRI = [P(up,event)-P(down,event)]-[P(up,nonevent)-P(down,nonevent)] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative~Only the 46 scans with autopsy from A16 are used for this outcome measure."|Scan acquired 50-60 minutes post injection||||Net Reclassification Index|||Number
2605658|NCT02107482|Secondary|Changes in Target Lesion Pruritus Visual Analog Scale (VAS) at Week 12||12 weeks||||Percent Change in Target Lesion Pruritus||Standard Deviation|Mean
2605661|NCT02107443|Secondary|Geriatric Assessment (GA) Summary and GA Targeted-recommendations Provided to Patients, Caregivers and Oncology Physicians Prior to Their Treatment Influences Caregiver Satisfaction With Communication About Age-related Issues.|"We will compare the effect of the intervention on caregiver satisfaction (the modified health care climate questionnaire-age for the caregiver). Will apply linear mixed model methodology. The total caregiver-HCCQ scores will be the response, and the arm will be the fixed effect. Estimation will be performed using Restricted Maximum Likelihood, and the null hypothesis of zero mean difference between arms will be tested using the Kenward-Roger small sample procedure. A 95% credible (confidence) interval will also be obtained from the posterior distribution. The specific practice site differences will be assessed graphically using Best Linear Unbiased Predictors (BLUP) of the mean response for each site."|At 4-6 weeks, 3 months and 6 months following the intervention||2019-10-31|10/2019||||
2605662|NCT02107443|Secondary|Geriatric Assessment (GA) Summary and GA Targeted-recommendations Provided to Patients, Caregivers and Oncology Physicians Prior to Their Treatment Influences Quality of Life of Older Patients Receiving Treatment and Their Caregivers.|Patient HRQoL will be assessed with the Functional Assessment Cancer therapy (FACT-G) and Caregiver HRQoL (burden) will be assessed with the Caregiver Reactions Assessment (CRA). We will include geriatric assessment impairment (at baseline and follow up) to evaluate if these influence patient-reported HRQoL differently in the intervention versus the usual care group. We will also compare whether the uptake of the geriatric assessment recommendations influences patient reported HRQoL and caregiver burden. Data from the intervention arm will be fit to a linear mixed model with the FACT-G or CRA as the outcome, number and percent (number implemented/number recommended) of interventions as the fixed effect, and National Cancer Institute Community Oncology Research Program (NCORP) site as a random effect independent of residual error. Analyses will be adjusted for treatment status.|At 4-6 weeks, 3 months and 6 months following the intervention||2019-10-31|10/2019||||
2605663|NCT02107443|Primary|Patient Satisfaction With Communication About Age-related Concerns: Measured by Health Care Climate Questionnaire (HCCQ). [NCI Specified]|"Will apply linear mixed model methodology. The total HCCQ scores will be the response, and the arm will be the fixed effect. HCCQ contains 7 questions, scale: 0-28. The higher the score the more satisfied the patients is with communication with their oncologists about age related concerns. Estimation will be performed using Restricted Maximum Likelihood, and the null hypothesis of zero mean difference between arms will be tested using the Kenward-Roger small sample procedure. 95% credible (confidence) interval will also be obtained from the posterior distribution. The specific practice site differences will be assessed graphically using Best Linear Unbiased Predictors (BLUP) of the mean response for each site."|Within 1-7 days of the baseline audio-recorded clinic consultation|"All baseline patients who were evaluable for this primary aim were included in this analysis.~Arm I patients excluded (2 patients withdrew, 19 patients with no HCCQ).~Arm II patients excluded (3 patients withdrew, 9 no HCCQ)."|||HCCQ total score||95% Confidence Interval|Least Squares Mean
2605664|NCT02107443|Primary|Direct Communication About Age-related Concerns: Number of Discussions Related to the Geriatric Assessment That Occur in the Clinic Visit Between the Patient, Oncology Physician, and Caregiver. [Patient-Centered Outcomes Research Institute Specified]|"A geriatric assessment (GA), a validated set of patient-centered outcomes, has been shown to identify concerns (e.g., function, cognition) important to older persons with cancer and their caregivers. The geriatric assessment was used to define which age related topics discussed between patients and providers would be coded. Will apply linear mixed model methodology. The total number of conversations will be the response, and the arm will be the fixed effect. Estimation will be performed using Restricted Maximum Likelihood, and the null hypothesis of zero mean difference between arms will be tested using the Kenward-Roger small sample procedure. A 95% credible (confidence) interval will be obtained from the posterior distribution. The specific practice site differences will be assessed graphically using the Best Linear Unbiased Predictors (BLUP) of the mean response for each site."|Baseline|"All baseline patients who were evaluable for this primary aim were included in this analysis.~Arm I patients excluded because 2 withdrew, 1 expired, 4 no audio captured and 2 primary aim protocol violations.~Arm II patients excluded (3 withdrew, 1 no audio captured)."|||Number of Conversations||95% Confidence Interval|Least Squares Mean
2605665|NCT02107339|Secondary|Chronic Persistent Surgical Pain-Weekly Frequency of Pain|0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant|12 months after surgery|A home postal survey was sent to participants in the clinical trial 12 months after surgery. 39 patients in the methadone group and 40 patients in the hydromorphone group returned the surveys|||score on a scale||Inter-Quartile Range|Median
2605666|NCT02107339|Secondary|Chronic Persistent Surgical Pain-Weekly Frequency of Pain|0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant|6 months after surgery|A home postal survey was sent to participants in the clinical trial 6 months after surgery. 24 patients in the methadone group and 32 patients in the hydromorphone group returned the surveys|||score on a scale||Inter-Quartile Range|Median
2605667|NCT02107339|Secondary|Chronic Persistent Surgical Pain-weekly Frequency of Pain|0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant|3 months after surgery|A home postal survey was sent to participants in the clinical trial 3 months after surgery. 38 patients in the methadone group and 27 patients in the hydromorphone group returned the surveys.|||score on a scale||Inter-Quartile Range|Median
2605668|NCT02107339|Secondary|Chronic Persistent Surgical Pain-Weekly Frequency of Pain|0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant|One month after surgery|A home postal survey was sent to participants in the clinical trial 1 month after surgery. 41 patients in the methadone group and 34 patients in the hydromorphone group returned the surveys|||score on a scale||Inter-Quartile Range|Median
2605669|NCT02107339|Secondary|Patient Satisfaction Scores|Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best))|Postoperative day 3||||units on a scale||Inter-Quartile Range|Median
2605670|NCT02107339|Secondary|Patient Satisfaction Scores|Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best))|postoperative day 2||||units on a scale||Inter-Quartile Range|Median
2605671|NCT02107339|Secondary|Patient Satisfaction Scores|Patient satisfaction with overall pain management will be determined using a 101-point verbal rating scale (0=highly dissatisfied (worst), 100=highly satisfied (best))|Postopertive day 1||||units on a scale||Inter-Quartile Range|Median
2605681|NCT02107313|Secondary|Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Events||Up to 15 days after the first dose of PBT2|Safety Population, as defined as all participants who received at least one dose of study drug|||participants|||Number
2605682|NCT02107313|Primary|Area Under the Concentration-Time Curve (AUC 0-t)||prior to the initial doses on day 1 and 8 and then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8,10,12,16, 24, 30, 36, 48 hours post each dose|PK Population, as defined as all participants who received at least one dose of PBT2 and had sufficient samples collected to determine PK parameters.|||h*ng/mL||Standard Deviation|Mean
2605683|NCT02107300|Secondary|Mean Rate of Dry Mouth as Assessed by Xerostomia Questionnaire|To assess whether the daily use of NeutraSal will prevent or reduce dry mouth perception in OSAS patients undergoing CPAP therapy. Dry Mouth perception will be measured by an Xerostomia Questionnaire which rates mouth dryness. The scale is rated from 1-10 (1 being dry as a desert and 10 is normal)|Baseline through 12 weeks||||score on a scale||Standard Deviation|Mean
2605684|NCT02107300|Primary|Change in Percentage of Time With CPAP (Continuous Positive Airway Pressure) Usage|To observe the impact of NeutraSal on OSAS (obstructive sleep apnoea syndrome) patients compliance to CPAP (Continuous Positive Airway Pressure) therapy compared to placebo. CPAP usage is determined by % of nights CPAP use was greater than 4 hours.|Baseline and 12 weeks||||percentage of time||Standard Deviation|Mean
2605685|NCT02107274|Secondary|Spirometric Values: Forced Vital Capacity (FVC)|Pulmonary function testing using a spirometer will be carried out at visits 3, 6 and 8 inclusive. All testing should be done in the sitting position, except for obese patients, who commonly obtain deeper inspiration when tested in the standing position. Subjects should avoid the following prior to lung function testing: Smoking within 1 hour of testing Consuming alcohol within 4 hours of testing Performing vigorous exercise within 30 minutes of testing Wearing restrictive clothing around the chest or abdomen Eating a large meal within 2 hours of testing The following medications must be withheld prior to testing, with the minimum time from last dose indicated- short acting beta agonists (6 hours), long acting beta agonists (12 hours), ipratropium bromide (12 hours), antihistamines (12 hours), Iong acting bronchodilator combinations (12 hours)|Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)||||Litres||Standard Deviation|Mean
2605686|NCT02107274|Secondary|Spirometry Value; Forced Expiratory Volume at 1 Second (FEV1)|Pulmonary function testing using a spirometer will be carried out at visits 3, 6 and 8 inclusive. All testing should be done in the sitting position, except for obese patients, who commonly obtain deeper inspiration when tested in the standing position. Subjects should avoid the following prior to lung function testing: Smoking within 1 hour of testing Consuming alcohol within 4 hours of testing Performing vigorous exercise within 30 minutes of testing Wearing restrictive clothing around the chest or abdomen Eating a large meal within 2 hours of testing The following medications must be withheld prior to testing, with the minimum time from last dose indicated- short acting beta agonists (6 hours), long acting beta agonists (12 hours), ipratropium bromide (12 hours), antihistamines (12 hours), long acting bronchodilator combinations (12 hours)|Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)||||Litres||Standard Deviation|Mean
2605687|NCT02107274|Secondary|Health Status: St George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire is to be administered at visits 3, 6 and 8 inclusive. It should be administered in a quiet room where the participant can answer the questions without interruption, prior to any other protocol related procedures|Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)||||Units||Standard Deviation|Mean
2605688|NCT02107274|Primary|24 Hour Sputum Volume|Each participant must be instructed and enabled to collect 24 hour sputum volumes over the 24 hours prior to visits 3, 6 and 8, inclusive. As this is the primary endpoint of the study, it is critical that 24 hour sputum volumes are measured and recorded accurately, observing the following protocol: The subject should be given a sterile jar to collect the sputum, which has been weighed previously for convenience. Each jar will be labelled with subject name, start and finish time/date The collection should commence on rising in the morning and complete 24 hours later. Ensure that the sputum sample has minimal saliva in the collection Instruct subject to collect all sputum produced spontaneously or after coughing over a single daytime 24 hour period. The sample should come from the lungs and should not be salivary. Encourage subject not to swallow sputum, but to collect. Each 24 hour collection period should be as similar as possible in terms of physiotherapy and exercise regimens|Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)|A total of 90 subjects were recruited. Among them, 78 subjects fulfilled the inclusion criteria and were randomized. Only 68 subjects completed the study and were subjected for analysis. We targeted to recruit 80 subjects and a dropout rate of 20% was anticipated as stated in the protocol.|||gram||Standard Deviation|Mean
2605689|NCT02107196|Secondary|Evaluation of Rebound Effects|"Comparison between average abdominal pain intensity (worst abdominal pain on a 0 to 10 NRS scale, where 0 corresponds to no pain and 10 corresponds to worst possible pain) and average stool consistency score (the patients reported Bristol Stool Chart score based on a 1 to 7 NRS scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea) during the 4-week RW presented as change to baseline.~The analysis only included the patients randomised to ibodutant in the 12-week treatment period and re-randomised to placebo for the 4-week RW period. Baseline was considered as the average abdominal pain intensity/stool consistency in the 2-week Run-in period."|4 weeks|modified RW population: only patients randomised to ibodutant in the 12-week treatment period and re-randomized to placebo for the 4-week RW period (excluding patients from one site, where a potential serious breach of GCP was reported, and another site, where disqualification proceedings against the Investigator were confirmed by FDA).|||units on a scale||Standard Deviation|Mean
2605690|NCT02107196|Secondary|Weekly Response for Relief of Overall IBS Signs and Symptoms Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).|"The patient will be considered a weekly responder if she has an IBS degree-of-relief equal to completely relieved/improved or considerably relieved/improved."|12 weeks|The secondary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA.|||percentage of responders|||Number
2605711|NCT02107014|Primary|Change in ICAM-1 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2605691|NCT02107196|Secondary|Weekly Response for Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).|"The patient will be considered a weekly stool consistency responder if she meets the following criterion:~Decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline. The patients reported Bristol Stool Chart score based on a 1 to 7 scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea."|12 weeks|The secondary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA.|||percentage of responders|||Number
2605692|NCT02107196|Secondary|Weekly Response for Abdominal Pain Intensity Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).|"The patient will be considered a weekly abdominal pain responder if she meets the following criterion:~Decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline."|12 weeks|The secondary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA.|||percentage of responders|||Number
2605693|NCT02107196|Primary|Weekly Response for Abdominal Pain Intensity AND Stool Consistency Over 12 Weeks of Treatment in at Least 50% of the Weeks of Treatment (6 Out of 12 Weeks).|"The patient will be considered a weekly responder if she meets both of the following criteria in the same week:~Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline;~Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline. The patients reported Bristol Stoll Chart score based on a 1 to 7 scale where 1 corresponds to hard stool and 7 corresponds to watery diarrhoea."|12 weeks|The primary efficacy analysis was performed on the modified ITT population (n=437): all patients included in the ITT population excluding patients from one site, where a potential serious breach of GCP was reported, and from another site, where disqualification proceedings against the Investigator were confirmed by the FDA.|||Percentage of Responders|||Number
2605694|NCT02107131|Secondary|Change in Contrast Sensitivity|To measure the mean change in contrast sensitivity scores on Pelli-Robson charts from baseline. Scale in assessing the log of the contract sensitivity score (CS score) is from 0-2.25, with 0 being no letters read on the contrast sensitivity chart, and 2.25 being all letters read on the contrast sensitivity chart. Total CS score = [(total # letters correct - 3) x 0.05].|12 months||||Units on a scale||Standard Deviation|Mean
2605695|NCT02107131|Secondary|Change in Visual Acuity|To determine the mean change in best-corrected visual acuity on ETDRS visual acuity chart at a starting distance of 4 meters from baseline. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning.|Month 12||||Letters||Standard Deviation|Mean
2605696|NCT02107131|Secondary|Change in Activity Productivity|To evaluate the mean change in activity impairment from baseline to 12 months using and activity impairment questionnaire. Scale is from 0-10 with 0 being lowest (no effect on my daily activities) and 10 being highest (completely prevented me from doing my daily activities).|Month 12||||Units on a scale||Standard Deviation|Mean
2605697|NCT02107131|Primary|A Change Between Two Time Points is Reported for Maximum Reading Speed|A change between two time points (Baseline and 12 months) is reported for Maximum Reading Speed.|Month 12|MNREAD words per minute|||words per minute||Standard Deviation|Mean
2605698|NCT02107092|Secondary|Proportion of Subjects With Average Serum Potassium Values ≤ 5.5 mmol/L|The proportions of subjects with average S-K values ≤ 5.5 mmol/L during Extended Dosing Study Days 8 to 337, inclusive|11 months|Entered Extended Dosing Phase, received study drug and had post baseline S-K values during the Extended Dosing Phase. The analysis population includes 121 subjects, where there is one subject who only had end-of-study post-baseline measurement and therefore was not presented in the participants analyzed.|||Proportion of Participants||95% Confidence Interval|Number
2605699|NCT02107092|Primary|Proportion of Subjects With Average Serum Potassium Values ≤ 5.1 mmol/L|The proportions of subjects with average serum potassium (S-K) values ≤ 5.1 mmol/L during Extended Dosing Study Days 8 to 337, inclusive|11 months|Entered Extended Dosing Phase, received study drug and had post baseline S-K values during the Extended Dosing Phase. The analysis population includes 121 subjects, where there is one subject who only had end-of-study post-baseline measurement and therefore was not presented in the participants analyzed.|||Proportion of Participants||95% Confidence Interval|Number
2605700|NCT02107014|Primary|Change in Overall Fibromyalgia Symptoms From Baseline.|"Visual analog scale (0-100) anchored at no symptoms at 0 and worst possible symptoms at 100. Improvement in overall fibromyalgia symptoms would be indicated by a decrease in the score."|Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||units on a scale||Standard Error|Mean
2605701|NCT02107014|Primary|Change in Pain From Baseline.|"Visual analog scale (0-100) anchored at no pain at 0 and worst possible pain at 100. Improvement in pain would be indicated by a decrease in the score."|Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||units on a scale||Standard Error|Mean
2605702|NCT02107014|Primary|Change in IL-22 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2605703|NCT02107014|Primary|Change in FaSL From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2605704|NCT02107014|Primary|Change in GROa From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2605705|NCT02107014|Primary|Change in Resistin From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2605706|NCT02107014|Primary|Change in Leptin From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2605707|NCT02107014|Primary|Change in PAI-1 From Baseline.||Baseline period (2 weeks) through end of drug phase (8 weeks) [10 weeks total].||||pg/mL||95% Confidence Interval|Median
2605765|NCT02106975|Secondary|Renal Function|Renal function as measured by Creatinine. Scores range from less than 1.2 to greater than 5.0 with higher scores indicating worse outcomes|Up to hour 168|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||Mg/dL||Full Range|Median
2605766|NCT02106975|Secondary|State of Consciousness|State of consciousness as measure by Glasgow Coma Scale which gives a score based on eye, verbal, and motor responses. Scores range from 3 to 15 with lower scores indicating worse outcome|Up to hour 168|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||units on a scale||Full Range|Median
2605767|NCT02106975|Secondary|Cardiovascular Function|Cardiovascular function as measured by Mean arterial pressure. Scores less than 70 mmHg indicate worse outcomes.|Up to hour 168|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||mmHg||Standard Deviation|Mean
2605768|NCT02106975|Secondary|Liver Function|Liver function as measured by Total Bilirubin. Normal levels range from 0.2 - 1.2. Levels greater than 1.2 indicate worse outcomes|Up to hour 168|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||Mg/dL||Full Range|Median
2605769|NCT02106975|Secondary|Coagulation|Coagulation as measured by Platelets per unit of blood. Scores range from less than 20 to more than 150. Lower scores indicate worse outcomes|Up to hour 168|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||Platelets/uL of Blood||Standard Deviation|Mean
2605770|NCT02106975|Secondary|Oxygenation Score: Saturation|Oxygenation as measure by the ratio of arterial oxygen saturation to fraction of inspired oxygen SpO2/FiO2|Up to hour 168|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||Ratio||Standard Deviation|Mean
2605771|NCT02106975|Secondary|Oxygenation Score: Pressure|Oxygenation as measure by the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2). Scores range from 100 to 300 with lower values indicating more worse outcomes|Up to hour 168|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||mm Mercury||Standard Deviation|Mean
2605772|NCT02106975|Secondary|Tissue Factor Pathway Inhibitor at Study Hour 0, 48, 96, 168||Up to hour 168|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||ng/ml||Standard Deviation|Mean
2605773|NCT02106975|Secondary|Receptor for Advanced Glycation Endpoints at Study Hour 0, 48, 96, 168||Up to hour 168|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||ng/ml||Standard Deviation|Mean
2605774|NCT02106975|Secondary|Procalcitonin at Study Hour 0, 48, 96, 168||Up to hour 168|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||ng/ml||Standard Deviation|Mean
2605775|NCT02106975|Secondary|Hospital-free Days at Day 60||Up to Day 60|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||days||Standard Deviation|Mean
2605776|NCT02106975|Secondary|All Cause Mortality to Day 28||Up to Day 28|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||percentage of participants|||Number
2605777|NCT02106975|Secondary|ICU-free Days at Day 28||Up to Day 28|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||days||Standard Deviation|Mean
2605778|NCT02106975|Secondary|Ventilator Free Days to Day 28||Up to Day 28|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||days||Standard Deviation|Mean
2605779|NCT02106975|Secondary|Ascorbate Level at Hour 0, 48, 96, 168||Up to hour 168|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||µM||Standard Deviation|Mean
2605780|NCT02106975|Secondary|mSOFA Scores at Hours 0, 48, 96|mSOFA is a single score based on patient status of five different biological systems: respiratory, cardiovascular, coagulation, renal, and neurological. Scores range from 0 to 20 with higher scores indicated worse status.|Up to hour 96|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||units on a scale||Inter-Quartile Range|Median
2605781|NCT02106975|Secondary|VE-40 (Vent RR x TV/Weight) x (PaCO2/40) at Study Hour 0, 48, 96, 168 if Still Intubated, in Ascorbate Infused Patient Compared to Placebo|Estimate of Shunt|Up to hour 168|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||mmMercury||Standard Deviation|Mean
2605782|NCT02106975|Secondary|Oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) at Study Hour 0, 48, 96, 168 if Still Intubated in Ascorbate Infused Patient Compared to Placebo.||Up to hour 168|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||Index||Standard Deviation|Mean
2605783|NCT02106975|Primary|Thrombomodulin Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo||Up to 168 hours||||ng/ml||Standard Deviation|Mean
2605784|NCT02106975|Primary|C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo||up to 168 hours|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||µg/ml||Standard Deviation|Mean
2605785|NCT02106975|Primary|Modified Change in Sequential Organ Failure Assessment (mSOFA) Score|mSOFA is a single score based on patient status of five different biological systems: respiratory, cardiovascular, coagulation, renal, and neurological. Scores range from 0 to 20 with higher scores indicated worse status.|96 hours|3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient|||score on a scale||Standard Deviation|Mean
2605786|NCT02106962|Secondary|Local Infection|After using Tranexamic Acid and Bacitracin, local infection rate measured at the end of study|2 months|no local infection in any particioant|||participants||Full Range|Mean
2605787|NCT02106962|Primary|Clotting TIme|After completing dialysis, the clotting time of the arteriovenous fistula of each participant was measured, using either Tranexamic Acid 5% or Tranexamic Acid 25% and compared to the regular clotting time of the AV Fistula without using the Tranexamic Acid|13 minutes||||minutes||Full Range|Mean
2605788|NCT02106923|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Metformin|Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2605789|NCT02106923|Primary|Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Metformin|Maximum measured concentration of metformin in plasma|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2605790|NCT02106923|Primary|Cmax (Maximum Measured Concentration of the Analyte in Plasma, for Empagliflozin|Maximum measured concentration of empagliflozin in plasma (Cmax).|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2605791|NCT02106923|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity), for Empagliflozin|Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity).|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2605792|NCT02106923|Primary|AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point) for Metformin|Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2605793|NCT02106923|Primary|AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point), for Empagliflozin|Area under the concentration-time curve of empagliflozin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic (PK) set (PKS) which included all subjects of the treated set who provided at least one observation for at least one primary PK endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2605794|NCT02106884|Secondary|Laboratory Safety Assessment|Severe laboratory abnormalities (hematology and biochemistry grade 3 and higher). Worst grade per patient. All patients treated (Safety set).|Measured during treatment, from signature of informed consent to end of treatment, plus 30 days mandatory safety follow-up period. Duration of treatment was variable for each patient.|All pts treated (safety set). Analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses in treatment switchers will be published in a peer reviewed journal.|||Participants|||Count of Participants
2605795|NCT02106884|Secondary|Overall Survival|Overall survival was considered from start of treatment to death. All patients (ITT)|Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).|ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.|||Months||95% Confidence Interval|Median
2605796|NCT02106884|Secondary|Progression Free Survival|Progression free survival time was considered from start of treatment until the first observation of disease progression or death from any cause, whichever occurred first. All patients (ITT).|Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).|ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.|||Months||95% Confidence Interval|Median
2605817|NCT02106494|Secondary|Overall Complete Response Rate|To determine the effect of APF530 on complete response rates in the overall phase (0 to 120 hours) of CINV.|0 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.|||percentage of participants|||Number
2605797|NCT02106884|Secondary|Disease Control|Tumour response was assessed locally based on radiological assessments (CT/MRI) of target and nontarget lesions and considering the occurrence of new lesions, as per RECIST criteria. Tumour response was defined at each evaluation as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD). Best response during treatment was selected for each patient. Overall response is defined as the best tumor response on treatment for each patient. Disease control is defined as a best response on treatment of either CR, PR or SD (CR + PR + SD). Some patients were not evaluable for response (no scans available). Overall response rates were calculated based on the ITT set.|Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).|ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.|||Participants|||Count of Participants
2605798|NCT02106884|Secondary|Duration of Response (in Responders)|Duration of response was calculated from the date of first documented response to the date of progression (including SD after PR) or date of start of new treatment in not progressed, when available. In 2 patients with CR, periods of PR are included. For those not documented as progressed before death, an unknown duration was kept and considered missing data.|Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).|ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.|||Months||95% Confidence Interval|Median
2605799|NCT02106884|Secondary|Overall Response|Tumour response was assessed locally based on radiological assessments (CT/MRI) of target and nontarget lesions and considering the occurrence of new lesions, as per RECIST criteria. Tumour response was defined at each evaluation as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD). Best response during treatment was selected for each patient. Overall response (OR) is defined as the best tumor response on treatment for each patient. Responders were considered CR + PR. Some patients were not evaluable for response (no scans available). Overall response rates (ORR) were calculated based on the ITT set.|Measured during treatment and FU, from signature of informed consent to progression (variable for each patient), for a max of 3 years from database lock (when applicable).|ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.|||Participants|||Count of Participants
2605800|NCT02106884|Primary|QOL Global Health Status Deterioration-free Median Survival|The deterioration-free survival is defined as the Kaplan-Meier estimate of median survival time to definitive deterioration of the QOL score or death. See primary outcome 1 for scale description. The definitive deterioration of the QOL score is a decrease of at least 10 points (minimal clinical important difference) as compared to the baseline score, with no further improvement of more than 10 points as compared to the score qualifying the deterioration or with no data after the deterioration was observed. Death was also considered as an event if the patient did not experience deterioration before death. Patients without event were censored at the time of last follow-up.|From date of randomisation to end of follow up (max 3 years after database lock when applicable).|ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.|||Months||95% Confidence Interval|Median
2605801|NCT02106884|Primary|Deterioration-free Survival Rate of the QOL Global Health Status at 3, 6 and 12 Months (Mos)|"The QOL global health status (GHS) is a functional parameter derived from the EORTC QLQ - C30 questionnaire, based on questions 29 How would you rate your overall health during the past week? and 30 How would you rate your overall quality of life during the past week?. Transformed scores range from 0 to 100% with higher scores representing better outcomes. The deterioration free survival rate at 3 mos is defined as the Kaplan-Meier estimate of the probability of being alive and free of deterioration of the QOL score at 3 mos. The definitive deterioration of the QOL score is a decrease of at least 10 points (minimal clinical important difference) as compared to baseline, with no further improvement of more than 10 points as compared to the score qualifying the deterioration or with no data after deterioration. Death was also considered as an event if the patient did not experience deterioration before death. Patients without event were censored at the time of last follow-up."|From date of randomisation to 3, 6 and 12 months respectively|ITT analysis based on the treatment groups randomized at baseline. Pts in Arm B were allowed to switch to the combination treatment after the initial progression but were considered solely in Arm B for this ITT analysis, as per protocol. Subset analyses of combination data in treatment switchers will be published in a peer reviewed journal.|||percentage of participants|||Number
2605802|NCT02106832|Primary|Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo|Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.|||Days||95.1% Confidence Interval|Median
2605803|NCT02106832|Secondary|Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)|FEV1 was defined as the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS).|Baseline and end of treatment (Week 44/46)|FAS with participants evaluable for this outcome measure.|||Liter||Standard Deviation|Mean
2605897|NCT02106325|Secondary|Beck Scale for Suicidal Ideation (BSSI)|"BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63.~0-13 Indicates minimal depression 14-19 Indicates mild depression 20-28 Indicates Moderate depression 29-63 Indicates Severe depression"|40 minutes post-infusion||||units on a scale||Standard Error|Mean
2605804|NCT02106832|Secondary|Mean Change From Baseline in Patient Reported Outcome Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score at End of Treatment (Week 44/46)|The QoL-B was a disease-specific questionnaire developed for non-Cystic fibrosis Bronchiectasis. It covers 8 dimensions: physical functioning, role functioning, emotional functioning, social functioning, vitality, treatment burden, health perceptions, and respiratory symptoms. Each dimension was scored separately on a scale of 0 to 100, and higher scores represent better outcomes. For this outcome measure, the respiratory symptoms domain score was reported.|Baseline and end of treatment (Week 44/46)|FAS with participants evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
2605805|NCT02106832|Secondary|Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)|New pathogens were any of the pre-specified organisms not cultured before start of study medication. There was no imputation for participants who discontinued the study prematurely.|End of treatment (Week 44/46)|Full analysis set (FAS) included participants who were randomized.|||Percentage of participants|||Number
2605806|NCT02106832|Secondary|Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)|The SGRQ was a validated, disease-specific instrument that measures health-related quality of life (HRQoL) in adults with chronic obstructive pulmonary disease (COPD) and asthma and was later validated for use in bronchiectasis. The SGRQ covers 3 dimensions: symptoms, activity and impact on daily life. To determine the outcome, a score ranging from 1 to 100 was calculated for each individual domain and for the total score, and smaller scores indicate better health status. For this outcome measure, the symptoms component score was reported.|Baseline and end of treatment (Week 44/46)|FAS with participants evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
2605807|NCT02106832|Secondary|Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)|Pathogen eradication was defined as a negative culture result for all pre-specified pathogens at end of treatment (week 44 or 46 depending on treatment regimen) that were present in the participant at baseline. There was no imputation for participants who discontinued the study prematurely.|End of treatment (Week 44/46)|Full analysis set (FAS) included participants who were randomized.|||Percentage of participants|||Number
2605808|NCT02106832|Secondary|Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks|For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and worsening of at least one sign/symptom over 48 weeks.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.|||Participants|||Count of Participants
2605809|NCT02106832|Secondary|Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks|For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms over 48 weeks.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.|||Participants|||Count of Participants
2605810|NCT02106832|Primary|Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo|Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.|||Days||99.9% Confidence Interval|Median
2605811|NCT02106728|Secondary|Change in Caregiver Functioning|EDSIS measures impact of ED.Subscales:Nutrition:0-32;Guilt:0-20;Dysregulated Behaviour:0-28;Social Isolation:0-16;Total: 0-96.Higher scores mean more negative appraisals of caregiving.Scores are summed.2)FQ measures criticism in families. Subscales:Critical Comments: 10-40;Emotional over-involvement: 10-40;Total:20-80.Higher scores mean higher perceived criticism.Scores are summed.3)SPS measures perceived social support. Attachment:4-16;Social Integration:4-16;Reassurance of Worth:4-16;Reliable Alliance Guidance:4-16;Opportunity for Nurturance:4-16;Total:24-96.Higher scores indicate higher social support.Scores are summed.4)Devaluation of consumers and consumer families measures perceived discrimination and stigma. Two subscales are:devaluation of consumers(8-32);devaluation of consumer's families (7-28).Higher scores indicate higher levels of perceived discrimination and stigma. Subscales are summed separately.5)BDI, scored from 0-63:higher scores indicate higher levels of depression|Baseline, end of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy), three months post-treatment||||units on a scale||Standard Deviation|Mean
2605812|NCT02106728|Primary|Change in Weight|Change in weight is measured to gauge if there has been a loss, gain, or maintenance.|Baseline, End of treatment(8 weeks for multi-family therapy/average 10 weeks for supportive family therapy)||||pounds||Standard Deviation|Mean
2605813|NCT02106728|Primary|Dropout|3 months post enrollment in the study, participant's program completion is measures (completed, withdrawn, dropped out)|3 months post enrollment||||participants|||Number
2605814|NCT02106494|Secondary|Rate of No Emetic Episodes|To determine the effect of APF530 on the rate of no emetic episodes (vomiting or retching) in the overall phase (0 to 120 hours) of CINV.|0 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.|||percentage of participants|||Number
2605815|NCT02106494|Secondary|Overall Complete Control Rate|To determine the effect of APF530 on complete control rates defined as no more than mild nausea, no emetic episodes [vomiting or retching], and no use of rescue medications in the overall phase (0 to 120 hours) of CINV.|0 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.|||percentage of participants|||Number
2605816|NCT02106494|Secondary|Delayed Complete Control (CC) Rate|To determine the effect of APF530 on complete control rates defined as no more than mild nausea, no emetic episodes [vomiting or retching], and no use of rescue medications in the delayed phase (24 to 120 hours) of CINV.|24 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.|||percentage of participants|||Number
2606176|NCT02103218|Primary|Any Sex no Condom, Past 3 Months|Any sex no condom, past 3 months|12 months|Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.|||logistic GEE predicted probability as %||Standard Error|Least Squares Mean
2605818|NCT02106494|Primary|Delayed Phase Complete Response (CR) Rate|Percentage of Participants with no emesis and no rescue medication in patients receiving HEC in the delayed phase (24 to 120 hours) of CINV.|24 - 120 Hours|Modified Intent to Treat (mITT) - all subjects in the randomized population who receive study drug and a HEC regimen and have post-baseline efficacy data.|||percentage of participants|||Number
2605819|NCT02106455|Secondary|Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period|"Treatment compliance of this outcome measure refers to the percentage of participants who correctly follow medication. The reported data are percentage of participants in the classification including 4 specific degrees of treatment compliance; 90 % or more; 67 % or more and <90 %; 25 % or more and <67 %; less than 25 % or unknown."|Up to 48 weeks|Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.|||Percentage of participants|||Number
2605820|NCT02106455|Secondary|Percentage of Changes From Baseline in Serum Bone Alkaline Phosphatase (Serum BAP) Level at Final Assessment Point|Percentage of changes from baseline in serum BAP level at final assessment point (up to 48 weeks) was reported. Serum BAP is one of bone metabolism markers.|Baseline and final assessment point (Up to 48 weeks)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percentage of change||Standard Deviation|Mean
2605821|NCT02106455|Secondary|Percentage of Changes From Baseline in Urinary Deoxypyridinoline (Urinary DPD) Level at Final Assessment Point|Percentage of changes from baseline in urinary DPD level at final assessment point (up to 48 weeks) was reported. Urinary DPD is one of bone metabolism markers.|Baseline and final assessment point (Up to 48 weeks)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percentage of change||Standard Deviation|Mean
2605822|NCT02106455|Secondary|Percentage of Changes From Baseline in Urinary Type 1 Collagen Cross-Linked N-telopeptide (Urinary NTX) Level at Final Assessment Point|Percentage of changes from baseline in urinary NTX level at final assessment point (up to 48 weeks) was reported. Urinary NTX is one of bone metabolism markers.|Baseline and final assessment point (Up to 48 weeks)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percentage of change||Standard Deviation|Mean
2605823|NCT02106455|Secondary|Number of Participants Stratified by Assessment of Image Findings of Other Abnormalities at Final Assessment Point Compared With Baseline|"Other Abnormalities refer to bone abnormal findings excluding bone morphogenic abnormalities and trabecular bone structural abnormalities (see Outcome Measure 5 and 6). Investigator marked assessment of image findings of other abnormalities at final assessment point compared with baseline as follows; improved, unchanged, worsened. The reported data were the number of participants stratified by assessment of image findings at final assessment point."|Baseline and final assessment point (Up to 48 weeks)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Participants|||Count of Participants
2605824|NCT02106455|Secondary|Number of Participants Stratified by Assessment of Image Findings of Trabecular Bone Structural Abnormalities at Final Assessment Point Compared With Baseline|"Investigator marked assessment of image findings of trabecular bone structural abnormalities at final assessment point compared with baseline as follows; improved, unchanged, worsened. The reported data were the number of participants stratified by assessment of image findings at final assessment point."|Baseline and final assessment point (Up to 48 weeks)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Participants|||Count of Participants
2605825|NCT02106455|Secondary|Number of Participants Stratified by Assessment of Image Findings of Bone Morphogenic Abnormalities at Final Assessment Point Compared With Baseline|"Investigator marked assessment of image findings of bone morphogenic abnormalities at final assessment point compared with baseline as follows; improved, unchanged, worsened. The reported data were the number of participants stratified by assessment of image findings at final assessment point."|Baseline and final assessment point (Up to 48 weeks)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Participants|||Count of Participants
2605826|NCT02106455|Secondary|Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point|"Investigators marked severity of pain with a 4-point scale ranging from None to Very Severe (None, Mild, Severe, Very Severe) at baseline and the final assessment point. This scale was specified on the protocol of this observational study. The reported data were number of participants stratified by comparison of pain severity between baseline and final assessment point described as None (at baseline) to Severe (at final assessment point)."|Baseline and final assessment point (Up to 48 weeks)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Participants|||Count of Participants
2605827|NCT02106455|Secondary|Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point|Percentage of changes from baseline in serum ALP level at final assessment point (up to 48 weeks) was reported.|Baseline and final assessment point (Up to 48 weeks)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percentage of change||Standard Deviation|Mean
2605828|NCT02106455|Secondary|Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point|Percentage of changes from baseline in excess serum ALP level at final assessment point (up to 48 weeks) was reported.|Baseline and final assessment point (Up to 48 weeks)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percentage of change||Standard Deviation|Mean
2605829|NCT02106455|Primary|Percentage of Participants Who Had One or More Adverse Drug Reactions|Adverse drug reaction refers to adverse events related to administered drug.|Up to 48 weeks|Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.|||Percentage of Participants|||Number
2605830|NCT02106442|Secondary|Number of Participants Who Had One or More Adverse Drug Reactions|Adverse drug reaction refers to adverse events related to the administered drug.|Up to Month 36|Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.|||Participants|||Count of Participants
2605831|NCT02106442|Secondary|Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36)||Final assessment (up to Month 36)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2605832|NCT02106442|Secondary|Change From Baseline in Height at Final Assessment (up to Month 36)||Baseline and final assessment (up to Month 36)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.|||Centimeter||Standard Deviation|Mean
2605833|NCT02106442|Secondary|Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)||Baseline and final assessment (up to Month 36)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.|||Percent Change||Standard Deviation|Mean
2605834|NCT02106442|Secondary|Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36)||Baseline and final assessment (up to Month 36)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.|||Percent Change||Standard Deviation|Mean
2605835|NCT02106442|Secondary|Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36)||Baseline and final assessment (up to Month 36)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.|||Percent Change||Standard Deviation|Mean
2605836|NCT02106442|Secondary|Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36)||Baseline and final assessment (up to Month 36)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.|||Percent Change||Standard Deviation|Mean
2605837|NCT02106442|Secondary|Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)||Baseline and final assessment (up to Month 36)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.|||Percent Change||Standard Deviation|Mean
2605838|NCT02106442|Secondary|Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36)|BMD was measured by dual-energy X-ray absorptiometry.|Baseline and final assessment (up to Month 36)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.|||Percent Change||Standard Deviation|Mean
2605839|NCT02106442|Secondary|Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36)|BMD was measured by dual-energy X-ray absorptiometry.|Baseline and final assessment (up to Month 36)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.|||Percent Change||Standard Deviation|Mean
2605840|NCT02106442|Secondary|Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36)|BMD was measured by dual-energy X-ray absorptiometry.|Baseline and final assessment (up to Month 36)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.|||Percent Change||Standard Deviation|Mean
2605841|NCT02106442|Secondary|Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36)|BMD was measured by dual-energy X-ray absorptiometry.|Baseline and final assessment (up to Month 36)|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.|||Percent Change||Standard Deviation|Mean
2606284|NCT02101515|Other Pre-specified|Chorioamnionitis|Clinical diagnosis of Chorioamnionitis of the mother|"at time of delivery, 4 hours second stage for Extended 3 hours second stage for Usual"||||Participants|||Count of Participants
2605842|NCT02106442|Secondary|Cumulative Percentage of Participants With Femur Fractures|The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.|From baseline up to Month 36|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable at each time point.|||Percentage of Participants||95% Confidence Interval|Number
2605843|NCT02106442|Secondary|Cumulative Percentage of Participants With Non-Vertebral Body Fractures|The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.|From baseline up to Month 36|Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable at each time point.|||Percentage of Participants||95% Confidence Interval|Number
2605844|NCT02106442|Primary|Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures|The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.|From baseline up to Month 36|Vertebral fractures assessment population; The vertebral fractures assessment population was defined as participants who completed the survey and had evaluable vertebral fractures data at baseline and post-baseline time points. Number analyzed is the number of participants who were evaluable at each time point.|||Percentage of Participants||95% Confidence Interval|Number
2605845|NCT02106403|Secondary|Overall Sensory Liking of Study Products|Overall sensory liking of the study products was assessed immediately, 3min, 5 min and 15 min after products application. The assessment was done on a 9 point categorical scale where 1= Dislike it extremely, 2= Dislike it very much, 3= Dislike it moderately, 4= Dislike it slightly, 5= Neither like it nor dislike it, 6= Like it slightly, 7= Like it moderately, 8= Like it very much, 9= Like it extremely.|Immediatey, 3 min, 5 min and 15 min after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population|||Score on a scale||Standard Error|Least Squares Mean
2605846|NCT02106403|Primary|Participant-perceived Cooling Sensation at 15 Min|The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 15 min post study product application.|At 15 min after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population|||Score on a scale||Standard Error|Least Squares Mean
2605847|NCT02106403|Primary|Participant-perceived Cooling Sensation at 5 Min|The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 5 min post study product application.|At 5 min after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population|||Score on a scale||Standard Error|Least Squares Mean
2605848|NCT02106403|Primary|Participant-perceived Cooling Sensation at 3 Min|The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 3 min post study product application.|At 3 min after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population|||Score on a scale||Standard Error|Least Squares Mean
2605849|NCT02106403|Primary|Participant-perceived Cooling Sensation Immediately Post Product Application|The cooling sensation was assessed immediately after the study product application on 100 millimeter (mm) Visual Analogue Scale (VAS) (0-100 mm, where 0= no cooling and 100= extreme cooling).|Immediately after product application|Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population|||Score on a scale||Standard Error|Least Squares Mean
2605850|NCT02106390|Secondary|Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs)|A serious adverse event is any untoward medical occurrence that at any dose results in death/ is life threatening/requires prolonged hospitalization/Persistent or significant disability/incapacity/congenital anomaly/or birth defect.|Throughout the whole study period (from Day 1 upto Day 331)|Analysis was performed on the Unsolicited Safety Set. The Unsolicited safety set included all subjects who provided informed consent & demographic and/or baseline screening assessments, regardless of the subject’s randomization and treatment status in the trial and received a subject ID and provided post-vaccination unsolicited adverse event record|||Participants|||Count of Participants
2605851|NCT02106390|Secondary|Number of Subjects With Unsolicited Adverse Events|An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment.|From Day 1 to Day 7 after each vaccination (Days 1, 61, 121 and 301)|Analysis was performed on the Unsolicited Safety Set. The Unsolicited safety set included all subjects who provided informed consent & demographic and/or baseline screening assessments, regardless of the subject’s randomization and treatment status in the trial and received a subject ID and provided post-vaccination unsolicited adverse event record|||Participants|||Count of Participants
2605957|NCT02105701|Primary|Number of Participants Experiencing Adverse Events (AE)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 18 weeks|The All Participants as Treated (APaT) population consists of all participants who received at least one dose of study treatment.|||Number of participants|||Number
2605852|NCT02106390|Secondary|Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)|Number of subjects with solicited local and systemic AEs during the 7 days (including the day of vaccination) after any vaccination|From Day 1 (6 hours) to Day 7 after each vaccination (Days 1, 61, 121 and 301)|Analysis was performed on the Solicited Safety Set. The solicited safety set included all subjects who provide informed consent & provide demographic and/or baseline screening assessments, regardless of the subject’s randomization and treatment status in the trial and received a subject ID and provided post vaccination solicited adverse events data|||Participants|||Count of Participants
2605853|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y|"Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y at one month after the fourth vaccination (Day 331).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups."|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331)|||Percentage of subjects||95% Confidence Interval|Number
2605854|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y|Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.|At Day 301 (before the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample before the fourth vaccination (Day 301).|||Percentage of subjects||95% Confidence Interval|Number
2605855|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y|"Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y at one month after the third vaccination (Day 151).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups."|At Day 151 (one month before the third vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the third vaccination (Day 151)|||Percentage of subjects||95% Confidence Interval|Number
2605856|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y|"Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 and Y at baseline (Day 1).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups."|At Day 1|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (Day 1)|||Percentage of subjects||95% Confidence Interval|Number
2605857|NCT02106390|Secondary|Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y|"Percentages of subjects with four-fold increases in hSBA against each of the N. meningitidis serogroups A,C,W & Y at one month after the fourth vaccination (Day 331) over pre-fourth vaccination(Day 301).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.~For serogroups A, C, W and Y, 4-fold increase in titers was defined as post 4th vaccination titer ≥16 (if pre 4th vaccination titer was <4) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥4)."|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination (Day 331)|||Percentage of subjects||95% Confidence Interval|Number
2605858|NCT02106390|Secondary|Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains|"Percentage of subjects with four-fold increase in hSBA titers against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331) over pre-fourth vaccination (Day 301).~This outcome measure applies to only groups rMenB+ACWY and rMenB as the serogroup B indicator strains were assessed only for these two groups.~For serogroup B strains, 4-fold increase in titers was defined as post 4th vaccination titer ≥8 (if pre 4th vaccination titer was <2) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥2)."|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331) and before the fourth vaccination (Day 301).|||Percentage of subjects||95% Confidence Interval|Number
2605859|NCT02106390|Secondary|Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y|Geometric Mean Ratios(GMRs) of GMTs against each of the serogroups A,C,W-135 & Y were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination (Day 301).|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331) and before the fourth vaccination( Day 301).|||Ratio||95% Confidence Interval|Geometric Mean
2605860|NCT02106390|Secondary|Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains|Geometric Mean Ratios(GMRs) of GMTs against each of the serogroup B indicator strains- H44/76, 5/99, N98/254 & M10713 were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination(Day 301).|At Day 331 (one month after fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331) and before the fourth vaccination( Day 301).|||Ratio||95% Confidence Interval|Geometric Mean
2605958|NCT02105701|Primary|Percentage of Participants Achieving Undetectable HCV RNA 12 Weeks After Completing Study Therapy (SVR12)|HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|12 weeks after the end of all study treatment (up to 28 weeks)|The Full Analysis Set (FAS) population consists of all randomized subjects who receive at least one dose of study treatment.|||Percentage of participants||95% Confidence Interval|Number
2606285|NCT02101515|Other Pre-specified|Neonatal Intensive Care Unit Admission (Neonates)|One neonate was analyzed per mother|Birth until neonatal discharge||||Participants|||Count of Participants
2605861|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y|Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination (Day 331)|||Percentage of subjects||95% Confidence Interval|Number
2605862|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y|"Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the fourth vaccination (Day 301).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups."|At Day 301 (before the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample before the fourth vaccination (Day 301).|||Percentage of subjects||95% Confidence Interval|Number
2605863|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y|Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups.|At Day 151 (one month after the third vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the third vaccination (Day 151)|||Percentage of subjects||95% Confidence Interval|Number
2605864|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y|"Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the first vaccination (Day 1).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups."|At Day 1|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (Day 1)|||Percentage of subjects||95% Confidence Interval|Number
2605865|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains|"Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups."|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331)|||Percentage of subjects||95% Confidence Interval|Number
2605866|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains|"Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains before the fourth vaccination (Day 301).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups."|At Day 301 (before the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample before the fourth vaccination(Day 301).|||Percentage of subjects||95% Confidence Interval|Number
2605867|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains|"Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains at one month after third vaccination (Day 151).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups."|At Day 151 (one month after the third vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the third vaccination (Day 151)|||Percentage of subjects||95% Confidence Interval|Number
2605868|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains|"Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains at baseline (Day 1).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups."|At Day 1|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at baseline (day 1)|||Percentage of subjects||95% Confidence Interval|Number
2605869|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains.|"Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 one month after the fourth vaccination (Day 331).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups."|At Day 331 (One month after the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331)|||Percentage of subjects||95% Confidence Interval|Number
2605870|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains.|"Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the fourth vaccination (Day 301).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups."|At Day 301 (before the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample before the fourth vaccination(Day 301).|||Percentage of subjects||95% Confidence Interval|Number
2606008|NCT02105324|Secondary|Percentage of Time Participants Were Not Under Bionic Pancreas Control During the Bionic Pancreas Period|Percentage of time that the Bionic pancreas was not functioning properly due to loss of wireless connectivity.|5 days|All randomized participants who completed both periods of the study. Reported for the Bionic Pancreas period only.|||percentage of time||Standard Deviation|Mean
2605871|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains|"Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 one month after the third vaccination (Day 151).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups."|At Day 151 (one month after the third vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the third vaccination (Day 151).|||Percentage of subjects||95% Confidence Interval|Number
2605872|NCT02106390|Secondary|Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains|"Percentage of subjects with hSBA titers≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the first vaccination (Day 1).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups."|At Day 1|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline(Day 1)|||Percentage of subjects||95% Confidence Interval|Number
2605873|NCT02106390|Secondary|hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.|"hSBA GMTs against each of the N.meningitidis serogroups A, C, W-135, Y at one month after the fourth vaccination (Day 331).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups."|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination (Day 331).|||Titers||95% Confidence Interval|Geometric Mean
2605874|NCT02106390|Secondary|hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.|"hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y before the fourth vaccination (Day 301).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups."|At Day 301 (before the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample before the fourth vaccination(Day 301)|||Titers||95% Confidence Interval|Geometric Mean
2605875|NCT02106390|Secondary|hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y|"hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at one month after the third vaccination (Day 151).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups."|At Day 151 (one month after the third vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the third vaccination (Day 151).|||Titers||95% Confidence Interval|Geometric Mean
2605876|NCT02106390|Secondary|hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y.|"hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at baseline (Day 1).~This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups."|At Day 1|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (Day 1)|||Titers||95% Confidence Interval|Geometric Mean
2605877|NCT02106390|Secondary|hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.|"hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups."|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination( Day 331).|||Titers||95% Confidence Interval|Geometric Mean
2605878|NCT02106390|Secondary|hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.|"hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the fourth vaccination (Day 301).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups."|At Day 301 (before the fourth vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample before the fourth vaccination( Day 301).|||Titers||95% Confidence Interval|Geometric Mean
2605879|NCT02106390|Secondary|hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.|"hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the third vaccination (Day 151).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups."|At Day 151 (one month after the third vaccination)|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the third vaccination (Day 151)|||Titers||95% Confidence Interval|Geometric Mean
2605880|NCT02106390|Secondary|hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains.|"hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at baseline (Day 1).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups."|At Day 1|Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (day 1).|||Titers||95% Confidence Interval|Geometric Mean
2605881|NCT02106390|Primary|hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y|"hSBA titers against N. meningitidis serogroups A, C, W-135 and Y after receiving four doses of either rMenB+OMV NZ / MenACWY concomitantly administered versus corresponding response in subjects who received MenACWY administered alone were presented in terms of vaccine group specific GMTs.~This outcome measure applies to only rMenB+ACWY and MenACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups."|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Per Protocol set (PPS). The PPS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination and were not excluded due to reasons defined prior to analysis.|||Titers||95% Confidence Interval|Geometric Mean
2605882|NCT02106390|Primary|Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains|"Human serum bactericidal activity (hSBA) titers against each of the serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 after receiving 4 doses of rMenB+OMV NZ / MenACWY vaccines, concomitantly administered, versus corresponding response in subjects who received rMenB+OMV NZ administered alone, were presented in terms of vaccine group specific geometric mean titers (GMTs).~This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups."|At Day 331 (one month after the fourth vaccination)|Analysis was performed on the Per Protocol set (PPS). The PPS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination and were not excluded due to reasons defined prior to analysis.|||Titers||95% Confidence Interval|Geometric Mean
2605883|NCT02106351|Other Pre-specified|Mean Change From Baseline to TC 1, Week 16 in the Paediatric Quality of Life (PedsQL) Scores|Parents/guardians completed questionnaires on their child's quality of life. The PedsQL parent inventory measured healthcare concepts for children/adolescents aged 2-18 years. The Generic Core Scales include physical, emotional, social and school aspects. The CP module was also completed. Scores were transformed on a scale from 0 to 100 with higher scores indicating a better quality of life. Mean changes from baseline to TC 1, Week 16 are presented for the General Core Scale and for the CP module. A positive change from baseline indicates an improvement in quality of life.|Baseline (TC 1, Day 1) and TC 1, Week 16.|The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects who were assessed at each timepoint are presented.|||score on a scale||Standard Deviation|Mean
2605884|NCT02106351|Other Pre-specified|Mean GAS Total Score at TC 1, Week 16|The GAS is a functional 5-point scale used to measure progress towards individual therapy goals. At start of each TC, 1 to 3 individual goals were defined for each subject by investigator and child's parents/guardians/caregivers prior to treatment. Outcome to reach each goal was rated on a 5-point scale ranging from -2 to +2 (-2: much less than expected outcome, -1: somewhat less than expected outcome, 0: expected outcome, +1: somewhat more than expected outcome, +2: much more than expected outcome). Higher score indicates a better outcome. A GAS T-score was calculated as: 50+(10∑_(i=1)^n wi xi)/√(0.7∑_(i=1)^n wi^2 +0.3(∑_(i=1)^n wi)^2) where, xi = rating of ith goal post-baseline; wi = weight of ith goal, calculated as importance * difficulty as defined at baseline; n = number of goals assessed at baseline and post-baseline. A GAS T-score of 50 indicates goals achieved as expected. Scores below 50 reflect under attainment of goals and scores above 50 reflect over attainment of goals.|Baseline (TC 1, Day 1) and TC 1, Week 16.|The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with available data at the timepoint analysed are presented.|||T-score||Standard Deviation|Mean
2605885|NCT02106351|Other Pre-specified|Mean PGA Score at TC 1 Week 16|The PGA of treatment response was assessed by asking the investigator the following question: 'How would you rate the response to treatment in the subject's upper limb since the start of the study?'. Answers were on a 9-point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved). The mean scores for each treatment group at TC 1 Week 16 are presented.|Baseline (TC 1, Day 1) and TC 1, Week 16.|The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with available data at the timepoint analysed are presented.|||score on a scale||Standard Deviation|Mean
2605886|NCT02106351|Other Pre-specified|Mean Change From Baseline to TC 1 Weeks 6 and 16 in MAS Score in the Finger Flexors of the Study Limb|The MAS was used to assess muscle tone in the upper limb PTMG and consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM) when the affected part is moved in flexion or extension, 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension). The original score '+1' was given a derived numeric score of '2' and the higher numeric scores were incremented by 1 so that the MAS score range was from 0 to 5 with higher scores indicating greater muscle tone. A negative change from baseline indicates a decrease in muscle tone. Data is presented for subjects injected in the finger flexors.|Baseline (TC 1, Day 1) and TC 1, Weeks 6 and 16.|The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with data available at each timepoint and who were injected in the finger flexors are presented.|||score on a scale||Standard Deviation|Mean
2605887|NCT02106351|Other Pre-specified|Mean Change From Baseline to TC 1 Weeks 6 and 16 in MAS Score in the Wrist Flexors of the Study Limb|The MAS was used to assess muscle tone in the upper limb PTMG and consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM) when the affected part is moved in flexion or extension, 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension). The original score '+1' was given a derived numeric score of '2' and the higher numeric scores were incremented by 1 so that the MAS score range was from 0 to 5 with higher scores indicating greater muscle tone. A negative change from baseline indicates a decrease in muscle tone. Data is presented for subjects injected in the wrist flexors.|Baseline (TC 1, Day 1) and TC 1, Weeks 6 and 16.|The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with data available at each timepoint and who were injected in the wrist flexors are presented.|||score on a scale||Standard Deviation|Mean
2606009|NCT02105324|Secondary|Number of Severe Hypoglycemic Events|A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person.|Day 1, Days 1-5 and Days 2-5|All randomized participants who completed both periods of the study.|||severe hypoglycemic events|||Number
2605888|NCT02106351|Other Pre-specified|Mean Change From Baseline to TC 1 Weeks 6 and 16 in MAS Score in the Elbow Flexors of the Study Limb|The MAS was used to assess muscle tone in the upper limb PTMG and consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM) when the affected part is moved in flexion or extension, 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension). The original score '+1' was given a derived numeric score of '2' and the higher numeric scores were incremented by 1 so that the MAS score range was from 0 to 5 with higher scores indicating greater muscle tone. A negative change from baseline indicates a decrease in muscle tone. Data is presented for subjects injected in the elbow flexors.|Baseline (TC 1, Day 1) and TC 1, Weeks 6 and 16.|The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with data available at each timepoint and who were injected in the elbow flexors are presented.|||score on a scale||Standard Deviation|Mean
2605889|NCT02106351|Other Pre-specified|Mean Change From Baseline to TC 1 Week 16 in MAS Score in the TC 1 PTMG|The MAS was used to assess muscle tone in the upper limb PTMG and consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM) when the affected part is moved in flexion or extension, 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension). The original score '+1' was given a derived numeric score of '2' and the higher numeric scores were incremented by 1 so that the MAS score range was from 0 to 5 with higher scores indicating greater muscle tone. A negative change from baseline indicates a decrease in muscle tone.|Baseline (TC 1, Day 1) and TC 1, Week 16.|The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with data available at the timepoint analysed are presented.|||score on a scale||Standard Deviation|Mean
2605890|NCT02106351|Secondary|Mean Goal Attainment Scale (GAS) Total Score at TC 1, Week 6|The GAS is a functional 5-point scale used to measure progress towards individual therapy goals. At start of each TC, 1 to 3 individual goals were defined for each subject by investigator and child's parents/guardians/caregivers prior to treatment. Outcome to reach each goal was rated on a 5-point scale ranging from -2 to +2 (-2: much less than expected outcome, -1: somewhat less than expected outcome, 0: expected outcome, +1: somewhat more than expected outcome, +2: much more than expected outcome). Higher score indicates a better outcome. A GAS T-score was calculated as: 50+(10∑_(i=1)^n wi xi)/√(0.7∑_(i=1)^n wi^2 +0.3(∑_(i=1)^n wi)^2) where, xi = rating of ith goal post-baseline; wi = weight of ith goal, calculated as importance * difficulty as defined at baseline; n = number of goals assessed at baseline and post-baseline. A GAS T-score of 50 indicates goals achieved as expected. Scores below 50 reflect under attainment of goals and scores above 50 reflect over attainment of goals.|TC 1, Week 6.|The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with data available are presented.|||T-score||Standard Deviation|Mean
2605891|NCT02106351|Secondary|Mean Physician's Global Assessment (PGA) Score at TC 1, Week 6|The PGA of treatment response was assessed by asking the investigator the following question: 'How would you rate the response to treatment in the subject's upper limb since the start of the study?'. Answers were on a 9-point rating scale (-4: markedly worse, -3: much worse, -2: worse, -1: slightly worse, 0: no change, +1: slightly improved, +2: improved, +3: much improved and +4: markedly improved). The mean scores for each treatment group at TC 1, Week 6 are presented.|TC 1, Week 6.|The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6. Subjects with data available are presented.|||score on a scale||Standard Deviation|Mean
2605892|NCT02106351|Primary|Mean Change From Baseline to TC 1, Week 6 in MAS Score in the TC 1 PTMG|The MAS was used to assess muscle tone in the upper limb PTMG and consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the ROM) when the affected part is moved in flexion or extension, 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension). The original score '+1' was given a derived numeric score of '2' and the higher numeric scores were incremented by 1 so that the MAS score range was from 0 to 5 with higher scores indicating greater muscle tone. A negative change from baseline indicates a decrease in muscle tone.|Baseline (TC 1, Day 1) and TC 1, Week 6.|The mITT population consisted of all randomised subjects who received at least 1 injection of the study treatment and had a MAS score in the PTMG assessed at both baseline (TC 1, Day 1) and at TC 1, Week 6.|||score on a scale||Standard Deviation|Mean
2605893|NCT02106325|Secondary|Inpatient Treatment Alliance Scale (ITAS)|The I-TAS is a 10-item, Likert-style rating scale designed to assess a patient's composite treatment alliance as it develops across multi-disciplinary treatment components. The I-TAS was intended to measure the primary alliance factors identified by Hatcher and Barends (1996) of bond, goals and collaboration. Each question is scored on a scale of 0 (Completely False) to 6 (Completely True). Total scores on the ITAS range from 0 to 60, with higher scores representing greater alliance with the treatment team (better outcome). The reported score is an average of each participant's total score on the ITAS.|7 days post-infusion||||Scored units on ITAS Scale||Standard Error|Mean
2605894|NCT02106325|Secondary|Outpatient Follow-up Compliance|Scoring System: 0= not compliant, 1=compliant|1 Day||||units on follow up compliance scale||Standard Error|Mean
2605895|NCT02106325|Secondary|Length of Inpatient Stay||2 Weeks Post-infusion||||Days||Standard Error|Mean
2605896|NCT02106325|Secondary|Montgomery-Åsberg Depression Rating Scale Suicide Ideation Item (MADRS-SI)|"40 Minutes Post Infusion, The MADRS-S instrument has nine questions, with an overall score ranging from 0 to 54 points.~0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression."|40 minutes post-infusion||||units on a scale||Standard Error|Mean
2605898|NCT02106325|Secondary|Change in Treatment Alliance Score|The I-TAS is a 10-item, Likert-style rating scale designed to assess a patient's composite treatment alliance as it develops across multi-disciplinary treatment components. The I-TAS was intended to measure the primary alliance factors identified by Hatcher and Barends (1996) of bond, goals and collaboration. Each question is scored on a scale of 0 (Completely False) to 6 (Completely True). Total scores on the ITAS range from 0 to 60, with higher scores representing greater alliance with the treatment team (better outcome). The reported score is an average of each participant's total score on the ITAS.|Baseline and 16 weeks||||Scored units on a scale||Standard Error|Mean
2605899|NCT02106325|Primary|Hamilton Depression Scale (Ham-D)|"Although the HAM-D form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.~Sum the scores from the first 17 items 0-7= Normal 8-13= Mild Depression 14-18= Moderate Depression 19-22= Severe Depression >23= Very Severe Depression"|4-6 hours post-infusion||||Scored units on a scale||Standard Error|Mean
2605900|NCT02106325|Primary|Beck Depression Inventory-II (BDI-II)|"BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63.~0-13 Indicates minimal depression 14-19 Indicates mild depression 20-28 Indicates Moderate depression 29-63 Indicates Severe depression"|120 min post-infusion||||Scored units on a scale||Standard Error|Mean
2605901|NCT02106325|Primary|Evaluate the Effects of Ketamine on Depressive Symptomatology by Measuring Change in Score on the Montgomery-Asberg Depressive Rating Scale|"40 Minutes Post Infusion, The MADRS-S instrument has nine questions, with an overall score ranging from 0 to 54 points.~0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression."|Baseline and 16 weeks||||units on a scale||Standard Error|Mean
2605902|NCT02106156|Secondary|Percentage of Participants With the Most Frequent Concomitant Medications|Most frequent concomitant medications were defined as those, which were observed in >1 % of participants.|At Baseline (Day 1)|Only main analysis set had evaluable data for this outcome measure.|||percentage of participants|||Number
2605903|NCT02106156|Secondary|Duration of Peginterferon Alfa-2a Therapy|Treatment duration was evaluated for participants for whom dates of treatment start and end of therapy were documented.|Up to Week 72|Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.|||weeks||Full Range|Median
2605904|NCT02106156|Secondary|Percentage Cumulative Dose of Ribavirin Received|Data for the accumulation of the cumulative dose of ribavirin were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.|Up to Week 96|Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.|||percentage of cumulated dose||Full Range|Median
2605905|NCT02106156|Secondary|Percentage Cumulative Dose of Peginterferon Alfa-2a Received|Data for the accumulation of the cumulative dose of peginterferon alfa-2a were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.|Up to Week 96|Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.|||percentage of cumulated dose||Full Range|Median
2605906|NCT02106156|Primary|Percentage of Participants With Serious Adverse Drug Reactions (SADR)||Up to Week 96|Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.|||percentage of participants|||Number
2605907|NCT02106156|Primary|Percentage of Participants With Sustained Virologic Response (SVR)|SVR is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at least 12 weeks after the end of treatment at follow up. Follow-up visit occurred at 12 to 24 weeks following discontinuation of treatment.|Up to Week 96|Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.|||percentage of participants|||Number
2605908|NCT02106156|Primary|Percentage of Participants With End of Treatment (EOT) Response|EOT Response is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at the end of treatment.|Up to Week 72|Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.|||percentage of participants|||Number
2605909|NCT02106156|Primary|Percentage of Participants With Early Virologic Response (EVR)|EVR is defined as HCV-PCR assay result qualitatively negative and/or decline of viral load of ≥2 log levels and/or viral load ≤50 IU/ml at Week 12.|At Week 12|Only treated participants were analyzed for this Outcome Measure. In each analysis set only those participants were included for whom a valid HCV PCR result was available or who discontinued from treatment before Week 12.|||percentage of participants|||Number
2605910|NCT02106156|Primary|Percentage of Participants With Rapid Virologic Response (RVR)|RVR is defined as Hepatitis C-Virus (HCV) Polymerase Chain Reaction (PCR) assay result qualitatively negative and/or viral load ≤50 International Units/milliliter (IU/ml) at Week 4.|At Week 4|Only treated participants were analyzed for this Outcome Measure. In each analysis set only those participants were included for whom a valid HCV PCR result was available or who discontinued from treatment before Week 4.|||percentage of participants|||Number
2605922|NCT02105987|Secondary|Change From Baseline in GFR From Creatinine Adjusted Using MDRD Enzymatic Equation at Week 24|Renal markers included GFR from creatinine adjusted using modification of diet in renal disease (MDRD) enzymatic equation and summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||mL/second/1.73 meter square||95% Confidence Interval|Least Squares Mean
2605911|NCT02105987|Secondary|Number of Participants With Incidence of Genotypic and Phenotypic Resistance Meeting Confirmed Virologic Withdrawal Criteria Over 24 Weeks|"Genotypic and phenotypic testing was conducted for participants who met the confirmed virologic withdrawal criteria, i.e., confirmed HIV-1 RNA >=400 c/mL any time after Day 1. The sample from the suspected virologic withdrawal criterion visit was tested for HIV-1 PRO and RT genotype and phenotype and HIV-1 integrase genotype and phenotype (i.e., the first of the two consecutive results >=400 c/mL). At the time of the data cut-off for this Week 24 analysis, no participants met the confirmed virologic withdrawal criteria over 24 weeks; therefore, the virologic analyses were not assessed."|Baseline and up to 24 weeks|Viral Genotypic and Phenotypic Populations: Comprised of all participants in the ITT-E Population with available on-treatment genotypic and phenotypic resistance data, respectively, at the time confirmed virologic withdrawal criterion was met.||||||
2605912|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, Glucose at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||Percent||95% Confidence Interval|Geometric Mean
2605913|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, Soluble CD163 at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||Percent||95% Confidence Interval|Geometric Mean
2605914|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, Insulin at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||Percent||95% Confidence Interval|Geometric Mean
2605915|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, Homostat Model Assess of Insulin Resistance at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or african american, other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||Percent||95% Confidence Interval|Geometric Mean
2605916|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, D-Dimer at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or African American, Other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||Percent||95% Confidence Interval|Geometric Mean
2605917|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analyte, C-reactive Protein at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or African American, Other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||Percent||95% Confidence Interval|Geometric Mean
2605918|NCT02105987|Secondary|Percent Change From Baseline in Cardiovascular Marker Analytes at Week 24|Cardiovascular biomarkers were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, sex, race (white, black or African American, Other), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Percent||95% Confidence Interval|Geometric Mean
2605919|NCT02105987|Secondary|Percent Change From Baseline in Bone Marker Analytes at Week 24|Outcome Measure Description: Bone biomarkers analytes include bone specific alkaline phosphatase, osteocalcin, procollagen 1 n-terminal propeptide, type I collagen c-telopeptides and were analyzed based on log transformed data. Estimates were from an ANCOVA model adjusting for ART third agent class, interaction of treatment and original ART third agent class, age, sex (male or female), body mass index (BMI) (<25 kilogram per meter [kg/m] or >=25 kg/m), smoking status (never smoked or former smoker or current smoker), Baseline vitamin D (no vitamin D use at Baseline or vitamin D use at Baseline), and Baseline biomarker level.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Percent||95% Confidence Interval|Geometric Mean
2605920|NCT02105987|Secondary|Change From Baseline in Urine Albumin/Creatinine Ratio at Week 24|Renal markers included urine albumin/creatinine ratioand summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||Gram per mole (G/mol) creatinine||95% Confidence Interval|Least Squares Mean
2605921|NCT02105987|Secondary|Change From Baseline in Urea at Week 24|Renal markers included urea and summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||Millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2605923|NCT02105987|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) From Creatinine Adjusted Using CKD-EPI Equation at Week 24|Renal markers included GFR from creatinine adjusted using chronic kidney disease epidemiology collaboration (CKD-EPI) equation and summarized based on an OC data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||mL/second||95% Confidence Interval|Least Squares Mean
2605924|NCT02105987|Secondary|Change From Baseline in Creatinine at Week 24|Renal markers included creatinine and summarized based on an observed case (OC) data set at Week 24. Adjusted mean is the estimated mean change from Baseline in each biomarker at Week 24 in each arm calculated from an ANCOVA analysis of covariance model including the following covariates: treatment, original ART third agent class, interaction of treatment and original ART third agent class, and Baseline biomarker level. Differences are calculated as ABC/DTG/3TC - Current ART regimen.|Baseline and Week 24|Safety Population. Only participants with a non-missing value at Week 24 are included.|||Micromoles per liter (umol/L)||95% Confidence Interval|Least Squares Mean
2605925|NCT02105987|Secondary|Change From Baseline in Treatment Satisfaction at Week 4 and Week 24|The HIV treatment satisfaction questionnaire (TSQ) is a 10 item self-reported scale. Individual item scores range from 6 (very satisfied) to 0 (very dissatisfied). The treatment satisfaction total score (range 0-60) is the sum of all the 10 individual items. The general satisfaction/Clinical subscale (range 0-30) is the sum of the 5 clinical items and the lifestyle/ease subscale (range 0-30) is the sum of the remaining 5 lifestyle items. Last observation carried forward (LOCF) were used for the analysis. If a participant had a missing value at Week 24, his previous non-missing available value while on the same treatment was carried forward (ie the Week 4 or withdrawal value is used in the Week 24 summary for participants in the ABC/DTG3TC with missing Week 24 value). Data were analyzed using an ANCOVA model with factors including treatment, Baseline score and stratification factor. Treatment group difference (ABC/DTG/3TC-cART) estimate and 95% CI were presented.|Baseline, Week 4 and Week 24|ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Units on a scale||Standard Error|Mean
2605926|NCT02105987|Secondary|Change From Baseline in Fasting Lipids (Total Cholesterol/HDL Cholesterol Ratio) at Week 24|Change from Baseline for fasting lipid parameter total cholesterol/HDL cholesterol ratio. Adjusted mean is the estimated mean change from Baseline at Week 24 in each arm calculated from an analysis of covariance (ANCOVA) model which includes the following covariates: treatment, original ART third agent class, interaction of treatment and original ART 3rd agent, use of lipid modifying agent and Baseline lipid level. Difference is calculated as ABC/DTG/3TC - Current ART regimen. For fasting lipid assessments, an overnight fast is preferred; however, a minimum of a 6-hour fast was acceptable for participants with afternoon appointments.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points.|||Ratio||95% Confidence Interval|Least Squares Mean
2605927|NCT02105987|Secondary|Change From Baseline in Fasting Lipids (Cholesterol, LDL Cholesterol, HDL Cholesterol, and Triglycerides) at Week 24|Change from Baseline for each fasting lipid parameters included cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides. Adjusted mean is the estimated mean change from Baseline in each parameter at Week 24 in each arm calculated from an analysis of covariance (ANCOVA) model which includes the following covariates: treatment, original ART third agent class, interaction of treatment and original ART 3rd agent, use of lipid modifying agent and Baseline lipid level. Difference is calculated as ABC/DTG/3TC - Current ART regimen. For fasting lipid assessments, an overnight fast is preferred; however, a minimum of a 6-hour fast was acceptable for participants with afternoon appointments.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2605928|NCT02105987|Secondary|Number of Participants With AEs Leading to Withdrawal Over 24 Weeks|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, based on medical or scientific judgment and all events of possible drug-induced liver injury with hyperbilirubinemia.|Baseline and up to 24 weeks|Safety Population|||Participants|||Number
2605929|NCT02105987|Secondary|Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to 24 Weeks|The number of participants with maximum post-Baseline emergent hematology toxicities for each grade were summarized by parameter. A toxicity is considered emergent if it develops or increases in intensity from Baseline. For participants who were originally randomized to current ART regimen on Day 1 and then switched to ABC/DTG/3TC on Week 24, Baseline is defined as the last non-missing value from the early switch phase and maximum post-Baseline emergent during the late switch phase was determined relative to this Baseline. The DAIDS table for grading the severity of adult and pediatric AEs was utilized for AE reporting. The DAIDS defined the severity grade as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening) for each parameter.|Baseline and up to 24 weeks|Safety Population|||Participants|||Number
2605930|NCT02105987|Secondary|Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to 24 Weeks|The number of participants with maximum post-Baseline emergent chemistry toxicities for each grade were summarized by parameter. A toxicity is considered emergent if it develops or increases in intensity from Baseline. For participants who were originally randomized to current ART regimen on Day 1 and then switched to ABC/DTG/3TC on Week 24, Baseline is defined as the last non-missing value from the early switch phase and maximum post-Baseline emergent during the late switch phase was determined relative to this Baseline. The DAIDS table for grading the severity of adult and pediatric AEs was utilized for AE reporting. The DAIDS defined the severity grade as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening) for each parameter.|Baseline and up to 24 weeks|Safety Population|||Participants|||Number
2605931|NCT02105987|Secondary|Number of Participants With Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 24 Weeks|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, based on medical or scientific judgment and all events of possible drug-induced liver injury with hyperbilirubinemia. The DAIDS table for grading the severity of adult and pediatric AEs was utilized for AE reporting. The DAIDS estimates the severity grade as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life threatening) for each parameter.|Baseline and up to 24 weeks|Safety Population: all participants who received at least one dose of study drug.|||Participants|||Number
2605932|NCT02105987|Secondary|Number of Participants in the Virologic Non-response Category From the Snapshot Analysis at Week 24|Virologic non-responders were defined as the participants with a viral load >=50 c/mL in the Week 24 analysis window. Virologic non-response includes participants who had HIV-1 RNA >=50 c/mL, who discontinued for lack of efficacy, who discontinued for other reasons while not suppressed, data in window but not <50 c/mL, and who changed ART regimen at Week 24. Difference is calculated as the proportion on ABC/DTG/3TC - proportion on current ART regimen.|Week 24|ITT-E Population|||Participants|||Number
2605933|NCT02105987|Secondary|Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Week 24|Change from Baseline in CD4+ cell counts were assessed at Baseline, Weeks 4, 8, 16 and 24. No imputation for missing data or premature discontinuation was performed and the observed values were used. Baseline value is defined as the last pre-treatment value observed. Change from Baseline was calculated as the observed value minus the Baseline value. The Week 24 data were summarized.|Baseline and Week 24|ITT-E Population. Only participants with non-missing CD4 data at Week 24 are included.|||Cells per cubic millimeter (cells/mm^3)||Inter-Quartile Range|Median
2605934|NCT02105987|Primary|Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies Per Milliliter (c/mL) at Week 24 Using the Snapshot Algorithm|"The Food and Drug Administration (FDA) snapshot (Missing, Switch or Discontinuation = Failure) algorithm is intended to be primarily a virologic assessment of the endpoint, and as such follows a virology first hierarchy. Virologic Success (e.g., <50 c/mL) or virologic failure within an analysis window is typically determined by the last available HIV-1 RNA measurement in that window and in the treatment phase of interest (e.g., Week 24 snapshot outcomes of the early switch phase will not use HIV-1 RNA data from the late switch phase, even if such data is within the Week 24 analysis window). A virologic failure occurs when a participant changes to their ART regimen (e.g., addition of other ARTs to the study-specified regimens, or switches in components of the current ART regimen)."|Week 24|Intent-to-Treat Exposed (ITT-E) Population: all participants randomized to ABC/DTG/3TC and receive at least one dose of study drug or randomized to remain on current ART regimen and continue in the study past Day 1.|||Participants|||Number
2605935|NCT02105974|Secondary|Time to First On-treatment Occurrence of Moderate or Severe COPD Exacerbation|Time to first on-treatment exacerbation was analysed using a Cox proportional hazards model with terms for treatment, reversibility status and percent predicted FEV1 at screening. Exacerbation of COPD is defined by a worsening of symptoms requiring additional treatment. Moderate COPD exacerbation is worsening symptoms of COPD that require treatment with antibiotics and/or systemic corticosteroids. Severe COPD exacerbation is worsening symptoms of COPD that require treatment with in-patient hospitalization. The number of participants with On-Treatment moderate or severe COPD exacerbations are presented.|From the start of double blind study medication until visit 7 (week 12)/Early withdrawal|ITT Population|||Participants|||Number
2605936|NCT02105974|Secondary|Percentage of Rescue-free 24-hour Periods Over the Entire 12-week Treatment Period|Participants were given daily record cards for daily completion from BL (Week -1) through Week 12 (Visit 7) each morning and prior prior to taking study medication (i.e., single-blind and double-blind study medication), supplemental medication (albuterol [salbutamol] if received). Participants recorded number of occasions supplemental albuterol/salbutamol (MDI and/or nebules) or oxitropium bromide (applicable sites in Japan) used over the previous 24 hours and any medical problems that they had experienced and any medication used to treat these medical problems over the previous 24 hours. Rescue-free 24-hour periods are defined as the 24-hour periods in which the rescue medication (albuterol [salbutamol]) was not used. The percentage of 24-hour periods are summarized for the entire treatment period (12 weeks). Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, reversibility status (stratum), baseline (week -1) and region.|BL (Week -1), Week 1 to Week 12|ITT Population, all randomized participants who received at least one dose of study medication. Only those participants with at least 1 on treatment rescue medication measurement during the treatment period and without missing covariate information were analyzed.|||Percentage of rescue-free periods||Standard Error|Least Squares Mean
2605937|NCT02105974|Primary|Mean Change From Baseline (BL) in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1, on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 14, 28, 56 and 84. BL was defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, reversibility status (stratum), BL, region, day, day by BL and day by treatment interactions.|Baseline to Day 84|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis|||Liter||Standard Error|Least Squares Mean
2605956|NCT02105701|Primary|Number of Participants Discontinuing Study Treatment Due to an AE|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 16 weeks|The All Participants as Treated (APaT) population consists of all participants who received at least one dose of study treatment.|||Number of participants|||Number
2605938|NCT02105961|Secondary|Change From Baseline in Mean COPD Assessment Test (CAT) Score|The CAT is an 8-item questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Each question is assessed on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment) with the CAT score ranging from 0-40. Higher scores indicate greater disease impact with reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product. Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Mean change from Baseline in CAT score at Week 52 has been presented.|Baseline and Week 52|mITT Population. Participants analyzed represents those with a Baseline and at least one post-Baseline assessment, and with no missing covariates.|||Score on CAT scale||Standard Error|Least Squares Mean
2605939|NCT02105961|Secondary|Change From Baseline in Mean Total St. George's Respiratory Questionnaire (SGRQ) Score|The SGRQ for COPD is a 40-item questionnaire derived from the original SGRQ , designed to measure health impairment by addressing the frequency of respiratory symptoms and current state of the participant. SGRQ Total Scores range from 0 to 100 with higher scores indicating worse health-related quality of life and reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product.Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Mean change from Baseline in SGRQ score at Week 52 has been presented.|Baseline and Week 52|mITT Population. Participants analyzed represents those with a Baseline and at least one post-Baseline assessment, and with no missing covariates.|||Score on SGRQ scale||Standard Error|Least Squares Mean
2605940|NCT02105961|Secondary|Rate of COPD Exacerbations Requiring Emergency Department (ED) Visits and/or Hospitalizations (Hosp)|COPD exacerbations requiring an ED visit and/or hosp occurring from the start of IP up to the Week 52 visit, including exacerbations reported after early discontinuation from IP by participants who remained in the study, were included in the analysis. This analysis was performed on the mITT population.|From randomization to Week 52|mITT Population|||Exacerbations requiring ED/hosp per year||95% Confidence Interval|Least Squares Mean
2605941|NCT02105961|Secondary|Time to First Moderate/Severe Exacerbation|Kaplan Meier estimates of the probability of a moderate or severe exacerbation are expressed as the percentage of participants with an exacerbation over time (by Week 8, 16, 24, 32, 40, 48, 52). Analysis of time to first moderate/severe exacerbation was performed on the mITT population and included exacerbations reported on-treatment and those reported after early discontinuation from IP by participants who remained in the study.|From randomization to Week 52|mITT Population|||Percentage of participants||95% Confidence Interval|Number
2605942|NCT02105961|Primary|Rate of Moderate or Severe Exacerbations|Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (>=24 hours) or result in death. Moderate and severe exacerbations occurring from the start of investigational product (IP) up to the Week 52 visit, including exacerbations reported after early discontinuation from IP by participants who remained in the study, were included in the analysis. The analysis was performed on the modified intent-to-treat (mITT) Population (all randomized participants who received at least one dose of study treatment).|From randomization to Week 52|mITT Population|||Moderate/severe exacerbations per year||95% Confidence Interval|Least Squares Mean
2605943|NCT02105948|Secondary|Change From Baseline in Mean CAT Score in the mITT Population|The CAT is an 8-item questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Each question is assessed on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment) with the CAT score ranging from 0-40. Higher scores indicate greater disease impact with reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product. Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Participants with a Baseline and at least one post-Baseline assessment were included in the analysis. Mean change from Baseline in CAT score at Week 52 has been presented. The strata were combined as pre-specified in the protocol and reporting and analysis plan (RAP).|Baseline and Week 52|mITT Population. Participants analyzed represents those with a Baseline and at least one post-Baseline assessment, and with no missing covariates.|||Score on CAT scale||Standard Error|Least Squares Mean
2605944|NCT02105948|Secondary|Change From Baseline in Mean Total SGRQ Score in the mITT Population|The SGRQ for COPD is a 40-item questionnaire derived from the original SGRQ, designed to measure health impairment by addressing the frequency of respiratory symptoms and current state of the participant. SGRQ Total Scores ranges from 0 to 100 with higher scores indicating worse health-related quality of life and reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product. Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Mean change from Baseline in SGRQ score at Week 52 has been presented. The strata were combined as pre-specified in the protocol and reporting and analysis plan (RAP).|Baseline and Week 52|mITT Population. Participants analyzed represents those with a Baseline and at least one post-Baseline assessment, and with no missing covariates.|||Score on SGRQ scale||Standard Error|Least Squares Mean
2605945|NCT02105948|Secondary|Rate of COPD Exacerbations Requiring ED Visit and/or Hosp in the mITT Population|COPD exacerbations requiring ED visit and/or hosp occurring from the start of IP up to the Week 52 visit, including exacerbations reported after early discontinuation from IP by participants who remained in the study, were included in the analysis. The analysis was performed on mITT Population. The strata were combined as pre-specified in the protocol and reporting and analysis plan (RAP).|From randomization to Week 52|mITT Population|||Exacerbations requiring ED/hosp per year||95% Confidence Interval|Least Squares Mean
2605946|NCT02105948|Secondary|Time to First Moderate/Severe Exacerbation in the mITT Population|Kaplan Meier estimates of the probability of a moderate/severe exacerbation are expressed as the percentage of participants with an exacerbation over time (by Week 8, 16, 24, 32, 40, 48, 52). The analysis was performed on the mITT population and included exacerbations reported on-treatment and those reported after early discontinuation from IP by participants who remained in the study. The strata were combined as pre-specified in the protocol and reporting and analysis plan (RAP).|From randomization to Week 52|mITT Population|||Percentage of participants||95% Confidence Interval|Number
2606286|NCT02101515|Other Pre-specified|Number of Participants With Shoulder Dystocia||"at time of delivery, 4 hours second stage for Extended 3 hours second stage for Usual"||||Participants|||Count of Participants
2605947|NCT02105948|Secondary|Change From Baseline in Mean COPD Assessment Test (CAT) Score in Participants in the High Stratum|The CAT is an 8-item questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Each question is assessed on a 6-point scale ranging from 0 (no impairment) to 5 (maximum impairment) with the CAT score ranging from 0-40. Higher scores indicate greater disease impact with reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product. Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Mean change from Baseline in CAT score at Week 52 has been presented.|Baseline and Week 52|mITT-H Population. Participants analyzed represents those with a Baseline and at least one post-Baseline assessment, and with no missing covariates.|||Score on CAT scale||Standard Error|Least Squares Mean
2605948|NCT02105948|Secondary|Change From Baseline in Mean Total St. George's Respiratory Questionnaire (SGRQ) Score in Participants in the High Stratum|The SGRQ for COPD is a 40-item questionnaire derived from the original SGRQ, designed to measure health impairment by addressing the frequency of respiratory symptoms and current state of the participant. SGRQ Total Scores ranges from 0 to 100 with higher scores indicating worse health-related quality of life and reductions indicating improvement. The Baseline value will be the last measurement collected prior to the first dose of investigational product. Change from Baseline is calculated as the post-dose visit value minus the Baseline value. Mean change from Baseline in SGRQ score at Week 52 has been presented.|Baseline and Week 52|mITT-H Population. Participants analyzed represents those with a Baseline and at least one post-Baseline assessment, and with no missing covariates.|||Score on SGRQ scale||Standard Error|Least Squares Mean
2605949|NCT02105948|Secondary|Rate of COPD Exacerbations Requiring an Emergency Department (ED) Visit and/or Hospitalization (Hosp.) in Participants in the High Stratum|COPD exacerbations requiring an ED visit and/or hosp. occurring from the start of IP up to the Week 52 visit, including exacerbations reported after early discontinuation from IP by participants who remained in the study, were included in the analysis. The analysis was performed on mITT-H Population.|From randomization to Week 52|mITT-H Population|||Exacerbations requiring ED/hosp per year||95% Confidence Interval|Least Squares Mean
2605950|NCT02105948|Secondary|Time to First Moderate/Severe Exacerbation in Participants in the High Stratum|Kaplan Meier estimates of the probability of a moderate or severe exacerbation are expressed as the percentage of participants with an exacerbation over time (by Week 8, 16, 24, 32, 40, 48, 52). Analysis was performed on the mITT-H Population and included exacerbations reported on-treatment and those reported after early discontinuation from IP by participants who remained in the study.|From randomization to Week 52|mITT-H Population|||Percentage of participants||95% Confidence Interval|Number
2605951|NCT02105948|Primary|Rate of Moderate or Severe Exacerbations in the mITT Population|Moderate and severe exacerbations occurring from the start of IP up to the Week 52 visit, including exacerbations reported after early discontinuation from IP by participants who remained in the study, were included in the analysis. The analysis was performed on the mITT Population which comprised of all randomized participants who received at least one dose of trial medication. The strata were combined as pre-specified in the protocol and reporting and analysis plan (RAP).|From randomization to Week 52|mITT Population|||Moderate/severe exacerbations per year||95% Confidence Interval|Least Squares Mean
2605952|NCT02105948|Primary|Rate of Moderate or Severe Exacerbations in Participants in the High Stratum|Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization ( >= 24 hours) or result in death. Moderate and severe exacerbations occurring from the start of investigational product (IP) up to the Week 52 visit, including exacerbations reported after early discontinuation from investigational product by subjects who remained in the study, were included in the analysis. The analysis was performed on the mITT high stratum (mITT-H) Population which comprised of participants in the mITT Population (all randomized participants who received at least one dose of study treatment) with blood eosinophil counts >=150 cells/µL at Screening or >=300 cells/ µL in the 12 months prior.|From randomization to Week 52|mITT-H Population|||Moderate/severe exacerbations per year||95% Confidence Interval|Least Squares Mean
2605953|NCT02105740|Secondary|Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS)|Comparison was made through the scores in the Hospital Anxiety and Depression Scale (HADS) to measure the effect of hypnosis in anxiety and depression among the 12 patients of the hypnosis group comparing to the 11 patients of the control group. The scale has 14 items, seven of which are directed to the evaluation of anxiety (HADS-A) and seven to depression (HADS-D). Each item can be scored from zero to three, establishing a score range of 0 to 21 points for each subscale. The better outcome occurs when the mean is lower or equal to 9 for each subscale. The subscales are independent for each result of depression and anxiety.|The study was done with each patient in the first three consecutive weeks after randomization|Were allocated 24 cancer patients, aged between 40-70 years, of both genders, with depression and anxiety score ≥ 9 in Hospital Anxiety and Depression Scale (HADS). One patient of the control group left the research.|||units on a scale||Standard Deviation|Mean
2605954|NCT02105740|Primary|Change of Pain Score in the Visual Analogue Scale|Comparison was made through the scores in the Visual Analogue Scale (VAS) to measure the effect of hypnosis in pain among the 12 patients of the hypnosis group comparing to the 11 patients of the control group. The scale ranged from 0 to 10 points, without subscales. The better outcome occurs when the mean of the second or the third week decrease 3 points comparing with the first week, or when the mean of the third week decrease 3 points comparing with the second week.|The study was done with each patient in the first three consecutive weeks after randomization|24 cancer patients were allocated. They were aged between 40-70 years, of both genders, with pain scores ≥ 3 measured by Visual Analogue Scale (VAS). One patient of the control group left the research.|||units on a scale||Standard Deviation|Mean
2605955|NCT02105701|Secondary|Percentage of Participants Achieving Undetectable HCV RNA 24 Weeks After the End of All Treatment (SVR24)|HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|24 weeks after the end of all study treatment (up to 40 weeks)|The Full Analysis Set (FAS) population consists of all randomized subjects who receive at least one dose of study treatment.|||Percentage of participants||95% Confidence Interval|Number
2606652|NCT02097472|Secondary|Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA)|Measured using ELISA|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
2605959|NCT02105688|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which has an LLOQ of 15 IU/mL. SVR24 was defined as HCV RNA <LLOQ at 24 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals for the SVR24 rate. The secondary efficacy analysis for Part A evaluated the percentage of participants in the immediate treatment arm (ITA) who achieved SVR24. SVR24 was also calculated for the Deferred Treatment Arm.|24 weeks after end of all therapy (Study Week 36 for Immediate Treatment Arm and Study Week 52 for Deferred Treatment Arm)|Modified FAS (mFAS): All randomized participants receiving ≥1 dose of active study treatment and excluding participants for study discontinuation for reasons unrelated to treatment regimen, response to HCV treatment, or BL genotype (GT)2, GT3, or GT5. The secondary efficacy analysis was evaluated within participants of the Immediate Treatment Arm.|||Percentage of Participants||95% Confidence Interval|Number
2605960|NCT02105688|Primary|Percentage of Participants Discontinued From Study Therapy Due to AEs During the DB Treatment Period|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. For this outcome measure, the primary safety analysis compared the percentage of participants discontinuing study therapy due to an AE in the Immediate Treatment Arm during the double-blinded active treatment period to that of the Deferred Treatment Arm during the double-blinded placebo treatment period.|DB Treatment period (up to Study Week 12)|All randomized participants who received at least one dose of study treatment during the Part A DB period.|||Percentage of Participants|||Number
2605961|NCT02105688|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Double-Blind (DB) Treatment Period and First 14 Follow-up Days|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. For this outcome measure, the primary safety analysis compared the percentage of participants experiencing an AE in the Immediate Treatment Arm during the double-blinded active treatment period to that of the Deferred Treatment Arm during the double-blinded placebo treatment period.|DB Treatment period plus first 14 follow-up days (up to Study Week 14)|All randomized participants who received at least one dose of study treatment during the Part A DB period.|||Percentage of Participants|||Number
2605962|NCT02105688|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a lower limit of quantification of 15 IU/mL. SVR12 was defined as HCV RNA below the lower limit of detection (<LLOQ) at 12 weeks after the end of all study therapy for baseline infection, or HCV RNA≥ LLOQ demonstrated to be due to reinfection (after clearance of baseline infection). The Clopper-Pearson method was used to construct 95% confidence intervals for the SVR12 rate. The primary efficacy analysis for Part A was the percentage of participants in the immediate treatment arm (ITA) who achieved SVR12. SVR12 was also calculated for the Deferred Treatment Arm.|12 weeks after end of all therapy (Study Week 24 for Immediate Treatment Arm and Study Week 40 for Deferred Treatment Arm)|Modified FAS (mFAS): All randomized participants receiving ≥1 dose of active study treatment and excluding participants for study discontinuation for reasons unrelated to treatment regimen, response to HCV treatment, or BL genotype (GT)2, GT3, or GT5. The primary efficacy hypothesis was evaluated within participants of the Immediate Treatment Arm.|||Percentage of Participants||95% Confidence Interval|Number
2605963|NCT02105662|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR24 was defined as undetectable (<9.3 IU/mL) HCV RNA at 24 weeks after the end of all study therapy.|24 weeks after end of all therapy (Study Week 36)|FAS; all allocated participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
2605964|NCT02105662|Primary|Percentage of Participants Discontinuing Study Therapy Due to AEs During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Treatment Period (up to 12 weeks)|APaT Population; all participants who received at least one dose of study treatment.|||percentage of participants|||Number
2605974|NCT02105558|Secondary|Neonatal Outcome as Assessed by (APGAR) Score|Apgar score is a method to quickly summarize the health of newborn children. The Apgar scale is determined by evaluating the newborn baby on five simple criteria [Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration]. Each crtieria is rated on a scale from 0 to 2, then summing up the five values thus obtained. The resulting Apgar total score ranges from zero to 10. Scores of 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.|5 minutes after birth||||units on a scale||Standard Deviation|Mean
2606899|NCT02096003|Secondary|Symptom Scale for Two Specific Side Effects of Nausea and Pruritus|Symptom scale for nausea and pruritus. Full scale from 1-5, with higher score indicating more symptoms.|up to 24 hours||||score on a scale||Full Range|Mean
2605965|NCT02105662|Primary|Percentage of Participants Experiencing Adverse Events (AEs) During the Treatment Period and First 14 Follow-up Days|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Treatment Period plus first 14 follow-up days (up to 14 weeks)|All Participants as Treated (APaT) Population; all participants who received at least one dose of study treatment.|||percentage of participants|||Number
2605966|NCT02105662|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 (High Pure System). The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 15 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR12 was defined as undetectable (<9.3 IU/mL) HCV RNA at 12 weeks after the end of all study therapy.|12 weeks after end of all therapy (Study Week 24)|Full Analysis Set (FAS); all allocated participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
2605967|NCT02105636|Other Pre-specified|Number of Participants With Death, Study Drug-Related Death, Serious Adverse Events (SAEs), and Study Drug-Related SAEs in All Treated Participants at Primary Endpoint|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Date of first dose of study drug to 30 days post last dose of study drug, approximately 18 months|All Treated Participants: All randomized participants who received at least one dose of study drug|||participants|||Number
2605968|NCT02105636|Secondary|Objective Response Rate (ORR)|ORR was defined as the proportion of randomized participants who achieved a best response of complete response (CR) or partial response (PR) using the RECIST1.1 criteria as per investigator assessment. Best overall response (BOR) was defined as the best response designation, recorded between the date of randomization and the date of progression, as assessed by the investigator per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. For participants without evidence of RECIST 1.1 progression or subsequent anticancer therapy, all available response assessments will contribute to the BOR assessment. For participants who continue treatment beyond progression, the BOR was determined based on response assessments up to the time of initial RECIST 1.1 progression.|Randomization to disease progression or study drug is discontinued, whichever occurs first; Approximately 5 years||2019-09-30|09/2019||||
2605969|NCT02105636|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator (as per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria), or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants without any on study tumor assessments and did not die were censored on their date of randomization. Participants who received subsequent systemic anti-cancer therapy prior to documented progression were censored at the date of the last tumor assessment prior to the initiation of the new therapy.|Randomization to disease progression or death, whichever occurs first; Approximately 5 years||2019-09-30|09/2019||||
2605970|NCT02105636|Primary|Overall Survival (OS) Rate in All Randomized Participants at Primary Endpoint|The overall survival rate is the probability that a participant will be alive at 3, 6, 9, and 12 months following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.|Randomization to 3, 6, 9, and 12 months|All randomized participants|||percent probability of OS||95% Confidence Interval|Number
2605971|NCT02105636|Primary|Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint|Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) occurred at 218 deaths.|From date of randomization to date of death, approximately 18 months|All randomized participants.|||months||95% Confidence Interval|Median
2605972|NCT02105558|Secondary|Time From Second Stage of Labor to Delivery|The second stage of delivery begins after the cervix has dilated to 10 centimeters (cm).|from the second stage of labor to delivery (about 6 to 174 minutes)|Because 2 in the epidural arm and 6 in the CSE arm never dilated to 10cms and were c-sectioned, it was not possible to obtain this value for these 8 participants. For 1 in the epidural arm and 1 in the CSE arm, delivery time was not recorded and so the time from the second stage of labor to delivery could not be determined for these 2 participants.|||minutes||Standard Deviation|Mean
2605973|NCT02105558|Secondary|Time From Regional Anesthesia to Delivery||from regional anesthesia to delivery (about 86 - 1205 minutes)|For 2 participants in the CSE group, delivery time was not recorded and so the time from regional anesthesia to delivery could not be determined.|||minutes||Standard Deviation|Mean
2605988|NCT02105467|Primary|Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12)|Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR12 was defined as HCV RNA <Lower Limit of Quantification (<15 IU/mL) 12 weeks after the end of all study therapy.|Week 24 (12 weeks after the end of treatment)|The Full Analysis Set included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the Immediate Treatment group.|||Percentage of participants||95% Confidence Interval|Number
2605975|NCT02105558|Secondary|Neonatal Outcome as Assessed by (APGAR) Score|Apgar score is a method to quickly summarize the health of newborn children. The Apgar scale is determined by evaluating the newborn baby on five simple criteria [Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration]. Each crtieria is rated on a scale from 0 to 2, then summing up the five values thus obtained. The resulting Apgar total score ranges from zero to 10. Scores of 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.|1 minute after birth||||units on a scale||Standard Deviation|Mean
2605976|NCT02105558|Secondary|Maternal Satisfaction as Assessed by a Visual Analogue Scale (VAS)|Maternal Satisfaction was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of satisfaction.|24 hours after regional anesthesia|Data for 3 participants in the epidural arm and 8 participants in the CSE arm were not recorded.|||units on a scale||Standard Deviation|Mean
2605977|NCT02105558|Secondary|Childbirth Experience as Assessed by a Visual Analogue Scale (VAS)|Childbirth experience was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a better childbirth experience.|24 hours after regional anesthesia|Data for 3 participants in the epidural arm and 8 participants in the CSE arm were not recorded.|||units on a scale||Standard Deviation|Mean
2605978|NCT02105558|Secondary|Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)|Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.|24 hours after regional anesthesia|Data for 3 participants in the epidural arm and 8 participants in the CSE arm were not recorded.|||units on a scale||Standard Deviation|Mean
2605979|NCT02105558|Secondary|Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)|Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.|60 minutes after regional anesthesia|Data for 1 participant in the epidural arm were not recorded.|||units on a scale||Standard Deviation|Mean
2605980|NCT02105558|Secondary|Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)|Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.|30 minutes after regional anesthesia||||units on a scale||Standard Deviation|Mean
2605981|NCT02105558|Secondary|Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)|Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.|15 minutes after regional anesthesia||||units on a scale||Standard Deviation|Mean
2605982|NCT02105558|Secondary|Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)|Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.|baseline||||units on a scale||Standard Deviation|Mean
2605983|NCT02105558|Primary|Number of Participants With Vaginal Birth After Cesarean (VBAC)||at the time of delivery||||Participants|||Count of Participants
2605984|NCT02105467|Secondary|Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks After the End of Treatment (SVR24)|Hepatitis C Virus RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR24 was defined as HCV RNA <Lower Limit of Quantitation (<15 IU/mL) 24 weeks after the end of all study therapy.|Week 36 (24 weeks after the end of treatment)|The Full Analysis Set included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the Immediate Treatment group.|||Percentage of participants||95% Confidence Interval|Number
2605985|NCT02105467|Other Pre-specified|Percentage of Participants Achieving Sustained Virologic Response at 4 Weeks After the End of Treatment (SVR4)|Hepatitis C Virus RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay. SVR4 was defined as HCV RNA <Lower Limit of Quantitation (<15 IU/mL) 4 weeks after the end of all study therapy.|Week 16 (4 weeks after the end of treatment)|The Full Analysis Set included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the Immediate Treatment group.|||Percentage of participants||95% Confidence Interval|Number
2605986|NCT02105467|Primary|Percentage of Participants Discontinued From Study Treatment Because of an Adverse Event|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.|Up to Week 12 (end of Blinded Treatment)|The All Subjects as Treated population included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the blinded treatment period.|||Percentage of participants|||Number
2605987|NCT02105467|Primary|Percentage of Participants Experiencing at Least One Adverse Event|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.|Up to Week 14 (14 days after the Blinded Treatment was completed)|The All Subjects as Treated population included randomized participants who received at least one dose of study treatment. This outcome measure applied only to the blinded treatment period.|||Percentage of participants|||Number
2606007|NCT02105324|Secondary|Percentage of Time Without CGM Monitoring Data|Percentage of time without CGM monitoring data is the time when the participant's CGM device lost its CGM signal.|5 days|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
2605989|NCT02105454|Secondary|Percentage of Participants Achieving SVR12 by Prior Direct-acting Antiviral (DAA) Therapy|SVR12 is defined as participants having HCV RNA level lower than the LLoQ (<15 IU/mL in plasma), either target detected and unquantifiable or undetectable 12 weeks after the end of all study therapy. Prior DAA therapy regimen included boceprevir, telaprevir, simeprevir, or sofosbuvir taken concomitantly with peginterferon and ribavirin. Below categories specify with our without resistance-associated variants (RAVs) of the hepatitis C virus.|Up to 24 weeks|Per protocol population excludes participants due to important deviations from the protocol that may substantially affect the results of the primary and key secondary efficacy endpoints.|||Percentage of participants||95% Confidence Interval|Number
2605990|NCT02105454|Primary|Percentage of Participants Discontinuing Study Drug Due to an Adverse Event|Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 12 weeks|All participants as treated population defined as all participants who received at least one dose of study medication.|||Percentage of participants|||Number
2605991|NCT02105454|Primary|Percentage of Participants Experiencing Adverse Events|Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 40 weeks (from Day 1 [post-dose] through 24 [-12/+4] weeks following last dose of study drug)|All participants as treated population defined as all participants who received at least one dose of study medication.|||Percentage of participants|||Number
2605992|NCT02105454|Primary|Percentage of Participants Achieving Sustained Virologic Response (SVR) at 12 Weeks After the End of All Study Therapy (SVR12)|SVR12 is defined as participants having hepatitis C virus ribonucleic acid (HCV RNA) level lower than the limit of quantification (LLoQ, <15 IU/mL in plasma), either target detected and unquantifiable or undetectable 12 weeks after the end of all study therapy.|Up to 24 weeks|Per protocol population excludes participants due to important deviations from the protocol that may substantially affect the results of the primary and key secondary efficacy endpoints.|||Percentage of participants||95% Confidence Interval|Number
2605993|NCT02105415|Secondary|Number of Participants Experiencing Delirium Using Confusion Assessment Method in ICU|Comparison of number of participants who were positive for delirium using CAM-ICU between groups|up to 24 hours post study drug administration|The analysis of new onset delirium was restricted to subjects (54 etomidate, 62 KPA) who did not experience delirium pre-study drug.|||Participants|||Count of Participants
2605994|NCT02105415|Secondary|Intensive Care Unit Free Days|comparison of intensive care unit free days between the two groups|hospital discharge or day 28, whichever comes first||||days||Inter-Quartile Range|Median
2605995|NCT02105415|Secondary|Blood Product Transfusions|blood product transfusions [Red Blood Cells vs. non-Red Blood Cells] between the two groups|hospital discharge or day 28, whichever comes first||||Participants|||Count of Participants
2605996|NCT02105415|Secondary|Mechanical Ventilation Free Days|comparison of mechanical ventilation free days between the two groups|hospital discharge or day 28, whichever comes first||||days||Inter-Quartile Range|Median
2605997|NCT02105415|Secondary|Number of Participants With Adrenal Insufficiency|Incidence of adrenal insufficiency between ketamine/propofol admixture and etomidate. Adrenal insuffiency was evaluated with co-syntropin stimulation test.|up to 24 hours post study drug administration|A secondary outcome included adrenal testing in a subset of patients. Thus, cortisol levels were available for 29 subjects at 3 and 5 hours and 30 subjects at 23 and 25 hours.|||Participants|||Count of Participants
2605998|NCT02105415|Secondary|Vasopressor Use|The use of vasoactive medications to restore the blood pressure post-administration in the ketamine/propofol combination as compared to the etomidate group.|up to 24 hours post study drug administration|Data are presented for patients who had vasopressor data within the time frame|||Participants|||Count of Participants
2605999|NCT02105415|Secondary|Mortality|In-hospital/28 day mortality among patients in ketamine/propofol combination compared to in-hospital/28-day mortality in etomidate.|Hospital Discharge or Day 28, whichever comes first||||Participants|||Count of Participants
2606000|NCT02105415|Primary|Mean Arterial Pressure|Mean arterial pressure for the ketamine/propofol group at a 1:1 dose ratio compared to the etomidate group within the first 15 minutes post-administration in patients in need of urgent and/or emergent endotracheal intubation, as defined by any intubation within the intensive care unit excluding intubations for elective procedural events and codes.|baseline and every 5 minutes up to 15 minutes minutes post study drug administration|Data are presented for patients who had blood pressure measurements at baseline (within 15 minutes prior to study drug administration).|||mm Hg||Standard Deviation|Mean
2606001|NCT02105324|Secondary|Percentage of Participants Using Pramlintide During the Usual Care Period|The percentage of participants who used pramlintide to manage their diabetes during the Usual Care period.|5 days|All participants who completed both periods of the study. Results are reported for the Usual Care period only.|||percentage of participants|||Number
2606002|NCT02105324|Secondary|Percentage of Participants Using a Glucagon-Like Peptide-1 (GLP-1) Agonist During the Usual Care Period|The percentage of participants who used a GLP-1 agonist to manage their diabetes during the Usual Care period.|5 days|All participants who completed both periods of the study. Results are reported for the Usual Care period only.|||percentage of participants|||Number
2606003|NCT02105324|Secondary|Number of Unscheduled CGM Sensor Changes|The number of time a CGM sensor was replaced due to falling out or failing to report a glucose value.|5 days|All randomized participants who completed both periods of the study.|||CGM sensor changes|||Number
2606004|NCT02105324|Secondary|List of Technical Faults Associated With the Bionic Pancreas Including Cause and Resolution||5 days|Data was not collected and analyzed to this level of detail.||||||
2606005|NCT02105324|Secondary|Reliability Index|Reliability index was calculated as the percentage of time values were actually recorded by CGM.|Day 1, Days 1-5, and Days 2-5 in each period|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
2606006|NCT02105324|Secondary|Change From Baseline in Body Weight|The change in body weight collected at Day 5 of each period relative to Baseline. A negative change from Baseline indicates a reduction in body weight and a positive change from Baseline indicates an increase in body weight.|5 days|All randomized participants who completed both periods of the study.|||kg||Standard Deviation|Mean
2606010|NCT02105324|Secondary|Mean Nausea Index Score Using a Visual Analogue Scale (VAS)|Participants rated their nausea using a 0 to 10 centimeter (cm) VAS where 0=least severe nausea to 10=most severe nausea. The average nausea index scores from Day 1 to Day 5 were calculated|Day 1, Days 1-5, and Days 2-5 in each period|All randomized participants who completed both periods of the study.|||cm||Standard Deviation|Mean
2606011|NCT02105324|Secondary|Number of Bionic Pancreas Local Infusion Site Reactions|Local infusion site reactions are defined as pain at the infusion site of the Bionic Pancreas. Itching and redness may have also been present.|Day 1, Days 1-5 and Days 2-5|All randomized participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.|||infusion site reactions|||Number
2606012|NCT02105324|Secondary|Number of Unscheduled Infusion Set Changes|Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.|Days 2-5|All randomized participants who completed both periods of the study.|||unscheduled infusion set changes|||Number
2606013|NCT02105324|Secondary|Number of Unscheduled Infusion Set Changes|Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.|Days 1-5|All randomized participants who completed both periods of the study.|||unscheduled infusion set changes|||Number
2606014|NCT02105324|Secondary|Number of Unscheduled Infusion Set Changes|Infusion sets for administering insulin and glucagon were placed under the skin the in the abdomen, buttocks, arms, or legs. Infusion set changes due to pain, infusion set falling out or infusion set failure are reported. Camp policy was to suspect failure of the infusion set whenever ketonemia occurred, so failures may not have actually been set failures, but rather failure to deliver enough insulin.|Day 1|All randomized participants who completed both periods of the study.|||unscheduled infusion set changes|||Number
2606015|NCT02105324|Secondary|Carbohydrate Intake|Carbohydrate intake included meals, snacks and unscheduled carbohydrates administered when a participant's blood glucose was <80 mg/dl (or for symptoms at any glucose level). Carbohydrate intake per day was averaged and is reported in grams (g) per kilogram (kg) per day (g/kg/day).|Day 1, Days 1-5 and Days 2-5|All randomized participants who completed both periods of the study.|||g/kg/day||Standard Deviation|Mean
2606016|NCT02105324|Secondary|Daily Bolus Insulin Dose in the Bionic Pancreas Period|The first time the bionic pancreas was used in each participant, a partial meal-priming bolus based on the participant's body mass (0.05 units/kg) was delivered. After the first use, the size of the meal-priming bolus was adapted by the bionic pancreas to 75% of the 4-hour prandial insulin used for that meal type and size. Daily bolus insulin dose is reported in units per kilogram (kg) per day (U/kg).|Day 1 through Day 5|All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.|||U/kg/day||Standard Deviation|Mean
2606017|NCT02105324|Secondary|Daily Basal Insulin Dose in the Bionic Pancreas Period|The bionic pancreas automatically adapted insulin dosing to each individual's needs. When CGM data were not available (because of sensor failure or during the warm-up time after sensor replacement), the bionic pancreas automatically delivered a dose of basal insulin based on the mean basal dosing it had calculated at that time on previous days. Daily basal insulin dose is reported in units per kilogram (kg) per day (U/kg).|Day 1 through Day 5|All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.|||U/kg/day||Standard Deviation|Mean
2606018|NCT02105324|Secondary|Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm|Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day).|Day 1, Days 1-5, and Days 2-5 of each period|All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.|||µg/kg/day||Standard Deviation|Mean
2606019|NCT02105324|Secondary|Insulin Total Daily Dose|Insulin total daily dose is reported in units per kilogram per day (U/kg/day).|11 days|All randomized participants who completed both periods of the study.|||U/kg/day||Standard Deviation|Mean
2606020|NCT02105324|Secondary|Grams of Carbohydrate Taken for Hypoglycemia When Plasma Glucose <70 mg/dL|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L. These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L. A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15-20 min was less than 3.9 mmol/L.|Day 1, Days 1-5, and Days 2-5 of each period|All randomized participants who completed both periods of the study.|||grams of carbohydrate||Full Range|Median
2606021|NCT02105324|Secondary|Number of Carbohydrate Interventions for Hypoglycemia When Plasma Glucose <70 mg/dL|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). Participants were given 15 grams (g) of simple carbohydrates if their plasma glucose concentration dropped below 4.4 mmol/L. These simple carbohydrates were counted as interventions for study outcomes if the plasma glucose concentration was less than 3.9 mmol/L. A second intervention of 15 g of carbohydrate was given if a repeat measurement in 15-20 min was less than 3.9 mmol/L. The total number of carbohydrate interventions are reported.|Day 1, Days 1-5, and Days 2-5 of each period|All randomized participants who completed both periods of the study.|||carbohydrate interventions||Full Range|Median
2606022|NCT02105324|Secondary|Percentage of Days That CGM Data Was Used by Participants as Part of Their Usual Care|The percentage of days during the Usual Care period that participants used CGM data as part of their diabetes management.|Day 1, Days 1-5, and Days 2-5 of the Usual Care Period|All randomized participants who completed both periods of the study.|||percentage of days|||Number
2606023|NCT02105324|Secondary|Number of Plasma Glucose Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)|A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL.|Days 1-5||||times below threshold||Standard Deviation|Mean
2606024|NCT02105324|Secondary|Percentage of Participants With Mean Plasma Glucose <183 mg/dL|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%.|Day 1, Days 1 to 5, and Days 2 to 5 of each period|All randomized participants who completed both periods of the study.|||percentage of participants|||Number
2606025|NCT02105324|Secondary|Percentage of Participants With Mean Plasma Glucose <169 mg/dL|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%.|Day 1, Days 1 to 5, and Days 2 to 5 of each period|All randomized participants who completed both periods of the study.|||percentage of participants|||Number
2606026|NCT02105324|Secondary|Percentage of Participants With Mean Plasma Glucose <154 mg/dL|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.0%.|Day 1, Days 1 to 5, and Days 2 to 5 of each period|All randomized participants who completed both periods of the study.|||percentage of participants|||Number
2606027|NCT02105324|Secondary|Percentage of Time With Plasma Glucose Values by Ranges on Days 2 to 5|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: < 70 mg/dl (3.9 mmol/L), < 60 mg/dL (3.3 mmol/L), < 50 mg/dl (2.8 mmol/L).|Days 2 to 5 of each period|All randomized participants who completed both periods of the study.|||percentage of values||Standard Deviation|Mean
2606028|NCT02105324|Secondary|Percentage of Time With Plasma Glucose Values by Ranges on Days 1 to 5|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: < 70 mg/dL (3.9 mmol/L), < 60 mg/dL (3.3 mmol/L), < 50 mg/dL (2.8 mmol/L).|Days 1 to 5 of each period|All randomized participants who completed both periods of the study.|||percentage of values||Standard Deviation|Mean
2606029|NCT02105324|Secondary|Percentage of Time With Plasma Glucose Values by Ranges on Day 1|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The percentage of time that the plasma glucose concentration was less than the following ranges were calculated: < 70 mg/dl (3.9 mmol/L), < 60 mg/dL (3.3 mmol/L), < 50 mg/dl (2.8 mmol/L).|Day 1 of each period|All randomized participants who completed both periods of the study.|||percentage of values||Standard Deviation|Mean
2606030|NCT02105324|Secondary|Mean Plasma Glucose Values|Fingerstick plasma glucose measurements were obtained before meals, at bedtime, at midnight, and at about 3:45 AM (six scheduled measurements). The plasma glucose readings were averaged. The plasma glucose results on Day 1, Days 1 to 5 and Days 2 to 5 were averaged.|Day 1, Days 1 to 5, and Days 2 to 5 of each period|All randomized participants who completed both periods of the study.|||mg/dL||Standard Deviation|Mean
2606031|NCT02105324|Secondary|Number of CGMG Reported Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)|A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL.|Days 1-5||||times below threshold||Standard Deviation|Mean
2606032|NCT02105324|Secondary|Percentage of Participants With Mean CGMG Glucose <183 mg/dL|Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 183 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 8.0%.|Day 1, Days 1-5, and Days 2-5 of each period|All randomized participants who completed both periods of the study.|||percentage of participants|||Number
2606033|NCT02105324|Secondary|Percentage of Participants With Mean CGMG Glucose <169 mg/dL|Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 169 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.5%.|Day 1, Days 1-5, and Days 2-5 of each period|All randomized participants who completed both periods of the study.|||percentage of participants|||Number
2606034|NCT02105324|Secondary|Percentage of Participants With Mean CGMG Glucose <154 mg/dL|Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Hemoglobin A1C of 7.0%.|Day 1, Days 1-5, and Days 2-5 of each period|All randomized participants who completed both periods of the study.|||percentage of participants|||Number
2606035|NCT02105324|Secondary|Percentage of Time With CGMG Concentration by Ranges During Days 2 to 5|Glucose readings were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dl (2.8 mmol/L), < 70 mg/dl (3.9 mmol/L), 70-180 mg/dl (3.9 to 10.0 mmol/L), > 180 mg/dL (10.0 mmol/L).|Days 2 to 5 of each period|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
2606036|NCT02105324|Secondary|Percentage of Time With CGMG Concentration by Ranges During Days 1 to 5|Glucose readings were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dl (2.8 mmol/L), < 70 mg/dl (3.9 mmol/L), 70-180 mg/dl (3.9 to 10.0 mmol/L), > 180 mg/dL (10.0 mmol/L).|Days 1 to 5 of each period|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
2606037|NCT02105324|Secondary|Percentage of Time With CGMG Concentration by Ranges During Day 1|Glucose readings were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than the following ranges were calculated: < 50 mg/dL(2.8 mmol/L), < 70 mg/dL (3.9 mmol/L), 70-180 mg/dL (3.9 to 10.0 mmol/L), > 180 mg/dL (10.0 mmol/L).|Day 1 of each period|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
2606038|NCT02105324|Secondary|Mean CGMG Values|Glucose reading were taken every 5 minutes by the CGM. The glucose results for each time frame were averaged.|Day 1 and Days 1-5 in each period|All randomized participants who completed both periods of the study.|||mg/dL||Standard Deviation|Mean
2606653|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein|Measured using MSD|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
2606039|NCT02105324|Primary|Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 5|Glucose reading were taken every 5 minutes by the CGM. The percentage of time that the glucose concentration was less than 60 mg/dL [3.3 millimoles/liter (mmol/L)] during Days 2 through 5 was calculated.|Days 2 to 5 of each period|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
2606040|NCT02105324|Primary|Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 5|Glucose reading were taken every 5 minutes by the CGM. The CGM glucose results during Days 2 through 5 were averaged.|Days 2 to 5 of each period|All randomized participants who completed both periods of the study.|||milligrams/deciliter (mg/dL)||Standard Deviation|Mean
2606041|NCT02105285|Secondary|Change From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration|"Comparison of each group in change from baseline in intraocular pressure at Week 8 at 8 hours after IMP administration.~Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Baseline, Week 8 at 8 hours after IMP administration||||mmHg||95% Confidence Interval|Mean
2606042|NCT02105285|Secondary|Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration|"Comparison of each group in change from baseline in intraocular pressure at Week 8 at 2 hours after IMP administration.~Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Baseline, Week 8 at 2 hours after IMP administration||||mmHg||95% Confidence Interval|Mean
2606043|NCT02105285|Secondary|Intraocular Pressure at Week 8 at 8 Hours After IMP Administration|"Comparison of each group in intraocular pressure at Week 8 at 8 hours after IMP administration.~Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 at 8 hours after IMP administration||||mmHg||Standard Error|Mean
2606044|NCT02105285|Secondary|Intraocular Pressure at Week 8 at 2 Hours After IMP Administration|"Comparison of each group in intraocular pressure at Week 8 at 2 hours after IMP administration.~Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 at 2 hours after IMP administration||||mmHg||Standard Error|Mean
2606045|NCT02105285|Secondary|Intraocular Pressure at Week 8 Predose|"Comparison of each group in intraocular pressure at Week 8 Predose. Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 Predose||||mmHg||Standard Error|Mean
2606046|NCT02105285|Primary|Decrease From Baseline in Intraocular Pressure at Week 8 Predose|"Comparison of each group in change from baseline in intraocular pressure. Arm of a treatment group coming together with latanoprost / carteolol is a reference group． As for Primary Outcome and Secondary Outcome analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group."|Baseline, Week 8 Predose||||mmHg||95% Confidence Interval|Mean
2606047|NCT02105272|Secondary|Decrease From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration|"Comparison of each group in change from baseline in intraocular pressure at 8 at 8 hours after IMP administration.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Baseline, Week 8 at 8 hours after IMP administration||||mmHg||95% Confidence Interval|Mean
2606064|NCT02105012|Primary|Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) at the End of the Treatment Period|Change from baseline in morning pre-dose trough Forced Expiratory Volume in 1 second (FEV1) at the end of the Treatment Period.|Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)|Modified Intent to Treat Population (MITT)|||Liters||95% Confidence Interval|Least Squares Mean
2606048|NCT02105272|Secondary|Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration|"Comparison of each group in change from baseline in intraocular pressure at Week 8 at 2 hours after IMP administration.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Baseline, Week 8 at 2 hours after IMP administration||||mmHg||95% Confidence Interval|Mean
2606049|NCT02105272|Secondary|Intraocular Pressure at Week 8 at 8 Hours After IMP Administration|"Comparison of each group in intraocular pressure at Week 8 at 8hours after IMP administration.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 at 8 hours after IMP administration||||mmHg||Standard Error|Mean
2606050|NCT02105272|Secondary|Intraocular Pressure at Week 8 at 2 Hours After IMP Administration|"Comparison of each group in intraocular pressure at Week 8 at 2 hours after IMP administration.~The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome."|Week 8 at 2 hours after IMP administration||||mmHg||Standard Error|Mean
2606051|NCT02105272|Secondary|Intraocular Pressure at Week 8 Predose|Comparison of each group in intraocular pressure at Week 8 Predose. The number of subjects showed in the Participant Flow comes from all the subjects administered IMP. For efficacy analysis, on the other hand, several subjects were excluded from the analysis according to the statistical analysis plan. For example, subjects without IOP after administration were excluded. In addition, IOP measurement at 8 hours was not mandatory. That is why there are differences between the number in the Participant Flow and Outcome.|Week 8 Predose||||mmHg||Standard Error|Mean
2606052|NCT02105272|Primary|Decrease From Baseline in Intraocular Pressure||Baseline, week 8 predose||||mmHg||95% Confidence Interval|Mean
2606053|NCT02105246|Other Pre-specified|Change in Distance Completed on 6-minute Walk Test|Baseline to 6-month change in 6-minute walk test distance (feet) among patients who participated in home-based vs. center-based cardiac rehab.|6 months|This analysis compares 6-month change in 6-minute walk test distance (feet) among patients who participated in home-based cardiac rehab vs. patients who participated in center-based cardiac rehab.|||feet||Inter-Quartile Range|Median
2606054|NCT02105246|Other Pre-specified|Change in Distance Completed on 6-minute Walk Test|Baseline to 3-month change in 6-minute walk test distance (feet) among subjects who participated in home-based vs. center-based cardiac rehab.|3 months|This analysis compared 3-month change in 6-minute walk test distance among subjects who participated in home-based vs. center-based cardiac rehab. Data from participants who completed the 3 month follow up visit are presented.|||feet||Inter-Quartile Range|Median
2606055|NCT02105246|Primary|Participation in Cardiac Rehabilitation|Number of eligible patients who participated in at least one cardiac rehabilitation exercise session.|12 Months||||Participants|||Count of Participants
2606056|NCT02105116|Secondary|Progression Free Survival Probability for CR|Calculated using Kaplan-Meier estimation method. Corresponding 95% confidence interval will be provided. Of the 6 patients enrolled, all were ineligible to enter the experimental treatment phase of the study for failure to reach complete remission. Hence no outcomes are available.|At 2 years|||||||
2606057|NCT02105116|Primary|Response Rate, Determined by Duration of Complete Remission|Patients will be scored as being in continuous remission at 2 years or having relapsed sooner. Of the 6 patients enrolled, all were ineligible to enter the treatment phase of the study for failure to reach complete remission for allogenic treatment.|Up to 2 years|||||||
2606058|NCT02105116|Primary|Response Rate, Determined by Allogeneic Cell Therapy-related Mortality|Patients' response rate will be determined by allogeneic cell therapy-related mortality. Of the 6 patients enrolled, all were ineligible to enter the experimental treatment phase of the study for failure to reach complete remission. Hence no outcomes are available.|Up to 2 years|||||||
2606059|NCT02105116|Primary|Adverse Events Related to Experimental Therapy|"Patients will be observed for incidence of adverse events related to experimental therapy, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.~Of the 6 patients enrolled, all were ineligible to enter the experimental treatment phase of the study because of failure to reach complete remission. None of the enrolled patients received experimental therapy (allogeneic donor lymphocyte therapy). The one death occurred while receiving standard therapy prior to eligibility for experimental allogeneic therapy. The remained of patients were ineligible for experimental therapy because they did not obtain a complete remission after standard induction chemotherapy."|Up to 2 years|||||||
2606060|NCT02105012|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score|The ACQ-5 measures 5 symptoms (woken at night by symptoms, wake in the morning with symptoms, limitation of daily activities, shortness of breath, and wheeze). The scale is 0-6, where 0=minimum and 6=maximum|Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)|MITT|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2606061|NCT02105012|Secondary|Change From Baseline in Mean Number of Puffs of Rescue Ventolin HFA|Change from baseline in mean number of puffs of rescue Ventolin HFA|Baseline to Last 7 Days of Treatment|MITT|||Puffs/Day||95% Confidence Interval|Least Squares Mean
2606062|NCT02105012|Secondary|Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)|Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)|Baseline to Last 7 Days of Treatment Period|MITT|||Liters/min||95% Confidence Interval|Least Squares Mean
2606063|NCT02105012|Secondary|Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)|Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)|Baseline to Last 7 Days of Treatment Period|MITT|||Liters/min||95% Confidence Interval|Least Squares Mean
2606065|NCT02104947|Secondary|Reversal of Anticoagulation as Measured by Diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) After the First Vial of Idarucizumab and Before the Start of Second Vial|"Reversal of anticoagulation as measured by diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) after the first vial of idarucizumab and before the start of second vial.~Reversal is defined for patients with at least one post−dose coagulation test results and pre−dose result higher than 100% ULN (evaluable patients). Reversal is calculated as 100*(pre−dose value minus post dose value)/(pre−dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100."|after the first vial of idarucizumab and before the start of second vial on Day1|Treated Set|||percentage||95% Confidence Interval|Median
2606066|NCT02104947|Secondary|Cmin,1 of Unbound Sum (Free) Dabigatran|Cmin,1 (Minimum concentrations at any time point since the end of first vial of idarucizumab up to 4 hours after the completion of second vial) of unbound sum (free) dabigatran, provided that two vials given not more than 15 min apart in group A and B.|Since the end of first vial of idarucizumab up to 4 hours after the completion of second vial|The Pharmacokinetic Set (PKS): This analysis set was used for all PK analyses and was defined as all patients in the Treated Set who provided at least one PK data point.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2606067|NCT02104947|Secondary|Time to Cessation of Bleeding (for Group A Only)|Time to cessation of bleeding (for Group A only) since first infusion up to 24 hours after the completion of second infusion; bleeding status was to be categorized before and at several time points after treatment.|from the first infusion up to 24 hours after the last infusion on Day 1|Treated set with patients who stopped bleeding within 24 hours|||hours||95% Confidence Interval|Median
2606068|NCT02104947|Secondary|Occurrence of Major/Life-threatening/Fatal Bleeding (for Group B Only) Intraoperatively|Occurrence of major/life-threatening/fatal bleeding (for group B only) intraoperatively and up to 24 hours post-surgery were classified according to major or life-threatening bleeding (ISTH [International Society for Thrombosis and Hemostasis] definition). 95% Confidence Interval (CI) is from Clopper-Pearson method.|within 24 hours of surgery|Treated Set|||percentage of participants||95% Confidence Interval|Number
2606069|NCT02104947|Secondary|Duration of Reversal|Duration of reversal, defined as the time period a patient remained completely reversed based on dTT or ECT, up to 24 hours or re-starting the treatment of dabigatran.|from the first infusion up to 24 hours after the last infusion on Day 1|Treated Set|||hours||Standard Deviation|Mean
2606070|NCT02104947|Secondary|Reversal of aPTT and TT From Central Laboratory|"Reversal of anticoagulation as measured by Activated Partial Thromboplastin Time (aPTT) and Thrombin time (TT), at any time point since the end of first infusion up to 4 hours after the completion of the last infusion. Reversal is defined for patients with at least one post−dose coagulation test results and pre−dose result higher than 100% ULN (evaluable patients).~Reversal is calculated as 100* (pre−dose value minus post dose value)/(pre−dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100."|from the end of the first infusion up to 4 hours after the last infusion on Day 1|Treated Set|||percentage||95% Confidence Interval|Median
2606071|NCT02104947|Primary|Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of dTT or ECT|"Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time (dTT) or ecarin clotting time (ECT), at any time point from the end of the first infusion up to 4 hours after the last infusion.~Reversal is defined for patients with at least one post−dose coagulation test results and pre−dose result higher than 100% ULN (evaluable patients).~Reversal is calculated as 100* (pre−dose value minus post dose value)/(pre−dose value minus 100% x ULN); if calculated reversal is > 100, it was set to 100."|from the end of the first infusion up to 4 hours after the last infusion on Day 1|Treated Set|||percentage||95% Confidence Interval|Median
2606072|NCT02104895|Secondary|Excellent Cosmesis|Physician-rated cosmesis, Cosmetic outcome was scored on the four-category Harvard Breast Cosmesis Scale. An excellent cosmetic result score was assigned when the treated breast looked like the contralateral one; a good cosmetic score was assigned for minimal but identifiable radiation effects of the treated breast; a fair score was used if significant radiation effects were readily observable; a poor score was used for severe sequelae due to radiation effects|5 years||||percentage of participants|||Number
2606073|NCT02104895|Secondary|Acute Skin Toxicity|"Acute skin toxicity ≥ grade 2, here we report the percentage of participants in each arm who experienced Acute skin toxicity ≥ grade 2"|5 years||||percentage of participants|||Number
2606074|NCT02104895|Primary|Ipsilateral Breast Tumor Recurrence|"We defined local relapse (true recurrence) as the reappearance of the breast cancer in the index quadrant and ipsilateral breast tumours as any new breast cancer diagnosed in other quadrants of the same breast. The sum of local relapses and new ipsilateral breast tumours was defined as the ipsilateral breast tumour recurrence (IBTR). Locoregional tumour recurrence also included any recurrence in the ipsilateral axillary, supraclavicular, or internal mammary chain nodal regions.here we report the percentage of participants in each arm who experienced Ipsilateral Breast Tumor Recurrence"|5-year||||percentage of participants|||Number
2606075|NCT02104830|Secondary|Duration From ANC Nadir to ANC < 2.0 x 10^9/L||1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.|||days||Standard Deviation|Mean
2606076|NCT02104830|Secondary|Neutropenia Duration, Any Grade||1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.|||days||Standard Deviation|Mean
2606077|NCT02104830|Secondary|Low Level (Nadir) ANC x 10^9/L||1st cycle (week 3), 2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.|||cells x 10^9/L||Standard Deviation|Mean
2606078|NCT02104830|Secondary|The Incidence of Severe Neutropenia (Grade 3-4)||16 weeks|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.|||participants|||Number
2606079|NCT02104830|Secondary|The Duration of Grade 4 Neutropenia From the 2nd (Week 6) to 4th Cycle (Week 12);||2nd cycle (week 6), 3rd cycle (week 9), 4th cycle (week 12)|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.|||days||Standard Deviation|Mean
2606080|NCT02104830|Primary|Duration of Neutropenia CTCAE Grade 4|The primary endpoint, which will allow to compare the efficacy of the single dose of Extimia® versus nonpegylated daily filgrastim is the number of breast cancer patients developing CTCAE grade 3/4 neutropenia after the first AT chemotherapy cycle (doxorubicin+docetaxel).|3 weeks|The efficacy analysis included only those patients who received at least one dose of study drug, and who were participated in the study for 2 weeks or more.|||days||Standard Deviation|Mean
2606081|NCT02104804|Secondary|Analysis of Change in Mean Total Daily Dose of Insulin From Baseline to Week 24||Baseline to 24 weeks|232 and 230 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.|||IU||95% Confidence Interval|Least Squares Mean
2606082|NCT02104804|Secondary|The Analysis of Change in Fasting Plasma Glucose From Baseline to Week 24 (This Was the Average of Weeks 20 and 24)||Baseline to Average of Weeks 20 and 24|232 and 229 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 229 for this outcome measure respectively.|||mg/dL||95% Confidence Interval|Least Squares Mean
2606083|NCT02104804|Secondary|Percentage of Patients Achieving a Therapeutic Glycaemic Response of HbA1c <7%||At Week 24|229 and 227 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.|||% of participants|||Number
2606084|NCT02104804|Secondary|Analysis of Change in 120-minute PPG From Baseline to Week 24 During a Meal Tolerance Test||Baseline to 24 weeks|215 and 211 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.|||mg/dL||95% Confidence Interval|Least Squares Mean
2606085|NCT02104804|Secondary|Change in Postprandial Glucose AUC From Baseline to Week 24 During a Meal Tolerance Test||Baseline to 24 weeks|213 and 206 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.|||mg*min/dL||95% Confidence Interval|Least Squares Mean
2606086|NCT02104804|Primary|Change in HbA1c From Baseline to Week 24||Baseline to 24 weeks|229 and 227 indicate the number of participants with non-missing baseline and Week 24 values in the Full Analysis Set of 232 and 230 respectively.|||Percentage change||95% Confidence Interval|Least Squares Mean
2606087|NCT02104765|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve, Zero to Infinity ( AUC[0-∞])|AUC was evaluated to delineate dose proportionality for the dose cohorts using a power model for geometric means and coefficient of variation. Statistical analysis was not prespecified.|Day 1: Predose, 8 hr and 24 hour postdose|All participants who received at least 1 dose of study drug and had evaluable PK data.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2606088|NCT02104765|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2951742|Cmax was evaluated to delineate dose proportionality for the dose cohorts using a power model for geometric means and coefficient of variation. Statistical analysis was not prespecified.|Day 1: Predose, 8 hr and 24 hour postdose|All participants who received at least 1 dose of study drug and had evaluable PK data.|||nanogram/millliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2606089|NCT02104765|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section|Baseline through Day 197|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2606090|NCT02104752|Secondary|The Clinical Assessment Interview for Negative Symptoms (CAINS)|"The Clinical Assessment Interview for Negative Symptoms (CAINS) will be used to assess negative symptoms. This scale is comprised of 9 items that rate motivation and pleasure symptoms and 4 items that rate expression symptoms.~We are reporting the motivation subscale. The total score can range from 0-36 (summed over the 9 items), with lower scores being better (i.e., less symptomatology)."|Baseline, Week 4, Week 8||||Score on a Scale||Standard Deviation|Mean
2606091|NCT02104752|Secondary|Brief Psychiatric Rating Scale (BPRS)|The Brief Psychiatric Rating Scale (BPRS) will be the primary measure for assessing positive symptoms. We will be using the UCLA expanded 24-item version of the scale. The total score ranges from 24-168, with lower scores being better (i.e., less symptomatology).|Baseline, Week 4, Week 8||||Score on a Scale||Standard Deviation|Mean
2606092|NCT02104752|Secondary|Brain Derived Neurotrophic Factor (BDNF)|Serum will be collected at baseline, 4 weeks, and 8 weeks. BDNF concentrations will be quantified by enzyme-linked immunosorbent assay.|Baseline, Week 4, Week 8|Participant dropped at the 8 week follow-up|||pg/mL||Standard Deviation|Mean
2606093|NCT02104752|Secondary|Electroencephalogram (EEG) Mismatch Negativity Paradigm (MMN)|A passive attention auditory oddball paradigm will be used to assess MMN. For MMN, difference waves generated by subtracting the standard from deviant event related potentials (ERP) will be analyzed. The specific electrodes used to examine each component will be chosen based on maximal activity seen by inspection of the topographical maps. More negative values indicate a larger (i.e., better) MMN response.|Baseline, Week 4, Week 8||||microVolts||Standard Deviation|Mean
2606094|NCT02104752|Primary|Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)|This battery was developed as part of the National Institute of Mental Health (NIMH) sponsored Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Initiative to assess cognition in clinical trials of cognition enhancing drugs. The MCCB comprises 10 tests that assess 7 cognitive domains (speed of processing, verbal memory, visual memory, working memory, reasoning and problem solving, attention/vigilance, and social cognition). The MCCB takes approximately 65 minutes to administer and provides age and gender-corrected normed T-scores, including a global composite score and cognitive domain scores. The range of T-scores is between 0 to 100 with a mean of 50. Higher scores indicate better overall cognitive functioning.|Baseline, Week 4, Week 8||||Score on a Scale||Standard Deviation|Mean
2606095|NCT02104739|Secondary|Peak Forearm Blood Flow|Peak forearm blood flow via strain gauge venous occlusion plethysmography|6 hours after meal|Though 16 completed the exenatide, saxagliptin, and placebo arms, data is only reported for 15 because the study team was unsuccessful in collecting data for the first study patient. Data for the exenatide extended-release (ER) arm was only collected at baseline and 3 hours.|||mL per minute per 100mL of tissue||Standard Error|Mean
2606900|NCT02096003|Secondary|Patient Satisfaction Score|Patient satisfaction score - total scale of 1-5, with higher score indicating more satisfaction|at 24 hours||||score on a scale||Full Range|Mean
2606096|NCT02104739|Secondary|Peak Forearm Blood Flow|Peak forearm blood flow via strain gauge venous occlusion plethysmography|3 hours after meal|Though 16 completed the exenatide, saxagliptin, and placebo arms, data is only reported for 15 because the study team was unsuccessful in collecting data for the first study patient. Data for the exenatide extended-release (ER) arm was only collected at baseline and 3 hours.|||mL per minute per 100mL of tissue||Standard Error|Mean
2606097|NCT02104739|Secondary|Peak Forearm Blood Flow|Peak forearm blood flow via strain gauge venous occlusion plethysmography|baseline|Though 16 completed the exenatide, saxagliptin, and placebo arms, data is only reported for 15 because the study team was unsuccessful in collecting data for the first study patient. Data for the exenatide extended-release (ER) arm was only collected at baseline and 3 hours.|||mL per minute per 100mL of tissue||Standard Error|Mean
2606098|NCT02104739|Secondary|Free Fatty Acids|Free Fatty Acids|6 hours after meal|Data for the exenatide extended-release (ER) arm was only collected at baseline and 2 hours.|||millimoles per liter||Standard Error|Mean
2606099|NCT02104739|Secondary|Free Fatty Acids|Free Fatty Acids|4 hours after meal|Data for the exenatide extended-release (ER) arm was only collected at baseline and 2 hours.|||millimoles per liter||Standard Error|Mean
2606100|NCT02104739|Secondary|Free Fatty Acids|Free Fatty Acids|2 hours after meal|Data for the exenatide extended-release (ER) arm was only collected at baseline and 2 hours.|||millimoles per liter||Standard Error|Mean
2606101|NCT02104739|Secondary|Free Fatty Acids|Free Fatty Acids|baseline|Data for the exenatide extended-release (ER) arm was only collected at baseline and 2 hours.|||millimoles per liter||Standard Error|Mean
2606102|NCT02104739|Secondary|Triglycerides|triglycerides|6 hours after ingestion of meal|Data for the exenatide extended-release (ER) arm was only collected at baseline and 2 hours.|||milligrams per deciliter||Standard Error|Mean
2606103|NCT02104739|Secondary|Triglycerides|triglycerides|4 hours after ingestion of meal|Data for the exenatide extended-release (ER) arm was only collected at baseline and 2 hours.|||milligrams per deciliter||Standard Error|Mean
2606104|NCT02104739|Secondary|Triglycerides|triglycerides|2 hours after ingestion of meal|Data for the exenatide extended-release (ER) arm was only collected at baseline and 2 hours.|||milligrams per deciliter||Standard Error|Mean
2606105|NCT02104739|Secondary|Triglycerides|triglycerides|baseline|Data for the exenatide extended-release (ER) arm was only collected at baseline and 2 hours.|||milligrams per deciliter||Standard Error|Mean
2606106|NCT02104739|Primary|Monocyte NfkB Levels as Detected by Western Blotting|Monocyte NfkB p65 arbitrary units are quantified by densitometric analysis of the Western blots.|2 hours after ingestion of meal||||NfkB p65 arbitrary units||Standard Error|Mean
2606107|NCT02104739|Primary|Monocyte NfkB Levels as Detected by Western Blotting|Monocyte NfkB p65 arbitrary units are quantified by densitometric analysis of the Western blots.|baseline||||NfkB p65 arbitrary units||Standard Error|Mean
2606108|NCT02104583|Secondary|Time From First Dose of Study Drug to the First Occurrence of CV Hospitalization, Emergency Room (ER) Visit, or CV Death|CV hospitalizations, CV ER visits, and CV deaths were determined through the adjudication by the CEC. The events that were adjudicated as undetermined were considered cardiovascular related. For each participant, the time from the first dose of study drug to the first CV hospitalization or CV ER visit through the last day on study or, in absence of CV hospitalizations or CV ER visits, to a CV death were derived as (first event date - first dose date + 1). The participants without CV hospitalizations, CV ER visits, or CV death were censored at the last day on study. As planned, data was reported only for Cohort 2 and combined Cohorts 1 and 2. Time to first occurrence of CV hospitalization, ER visit, or CV death was analyzed using KM estimates.|From first dose of study drug up to 22 months|Participants in the Full Analysis Set with available data were analyzed.|||days||95% Confidence Interval|Median
2606109|NCT02104583|Secondary|Time From First Dose of Study Drug to the First Occurrence of Appropriate ICD Interventions (ATP or Shock) or Cardiovascular (CV) Death|CV deaths were determined through the adjudication by an external independent clinical event committee (CEC). The deaths that were adjudicated as undetermined were considered cardiovascular related. For each participant, the time from the first dose of study drug to the beginning of the earliest appropriate ICD intervention through the last day on study or, in absence of appropriate ICD interventions, to a CV death was derived as (first event date - first dose date + 1). The participants without appropriate ICD interventions or CV death were censored at the last day on study. As planned, data was reported only for Cohort 2 and combined Cohorts 1 and 2. Time to first occurrence of an appropriate ICD interventions or CV death was analyzed using Kaplan-Meier (KM) estimates.|From first dose of study drug up to 22 months|Participants in the Full Analysis Set with available data were analyzed.|||days||95% Confidence Interval|Median
2606110|NCT02104583|Secondary|Change in Left Ventricular Systolic and Diastolic Function as Assessed by Left Ventricular Ejection Fraction (LVEF)|LVEF is a measure of how much blood is pumped out of the left ventricle of the heart. Change from baseline was calculated as the value at Week 12 or 24 minus the value at Baseline.|Baseline to Week 12; Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of blood||Standard Deviation|Mean
2606111|NCT02104583|Secondary|Overall Occurrence (Total Number) of Inappropriate ICD Interventions Through Week 24 and End of Study||Randomization up to Week 24; Randomization up to end of study (up to 22 months)|Participants in the Full Analysis Set-ICD with available data were analyzed.|||events||Standard Deviation|Mean
2606112|NCT02104583|Secondary|Overall Occurrence (Total Number) of Electrical Storm Through Week 24 and End of Study|An electrical storm was defined as ≥ 3 separate episodes of ventricular arrhythmia within a 24-hour period terminated by ICD.|Randomization up to Week 24; Randomization up to end of study (up to 22 months)|Participants in the Full Analysis Set-ICD with available data were analyzed.|||events||Standard Deviation|Mean
2606113|NCT02104583|Secondary|Overall Occurrence (Total Number) of Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) (Treated or Untreated) Through Week 24 and End of Study||Randomization up to Week 24; Randomization up to end of study (up to 22 months)|Participants in the Full Analysis Set-ICD with available data were analyzed.|||events||Standard Deviation|Mean
2606138|NCT02104167|Primary|Percentage of Participants With Fusion|Rate of fusion using A/P, lateral, and flexion/extension radiographs at each time point; defined by the presence of bridging bone with less than 2° segmental motion in flexion/extension and less than 3mm of A/P translation.|12 months or more after device implantation; mean follow up 20.7 months||||Percentage of Participants|||Number
2606114|NCT02104583|Secondary|Change From Baseline in Nonsustained Ventricular Tachycardia (nsVT) Count as Assessed by Continuous cECG Monitoring|The count of nsVTs per 48 hours was obtained from cECG readings at Baseline and Week 12. Change in nsVT from baseline was measured in units of number of episodes/48 hours. Change from baseline was calculated as the value at Week 12 minus the value at Baseline.|Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||episodes/48 hours||Standard Deviation|Mean
2606115|NCT02104583|Secondary|Change From Baseline in Premature Ventricular Complex (PVC) Count as Assessed by Continuous Electrocardiogram (cECG) Monitoring|PVC count per 48 hours was obtained from cECG readings at Baseline and Week 12. Change in PVC from baseline was measured in units of number of episodes/48 hours. Change from baseline was calculated as the value at Week 12 minus the value at Baseline.|Baseline to Week 12|Participants in the Full Analysis Set (all participants who were randomized into the study and received at least 1 dose of study medication) with available data were analyzed.|||episodes/48 hours||Standard Deviation|Mean
2606116|NCT02104583|Secondary|Overall Occurrence (Total Number) of Appropriate ICD Interventions (ATP or Shock) Through End of Study||Randomization up to 22 months|Participants in the Full Analysis Set-ICD with available data were analyzed.|||events||Standard Deviation|Mean
2606117|NCT02104583|Primary|Overall Occurrence (Total Number) of Appropriate Implantable Cardioverter-Defibrillator Device (ICD) Interventions (Anti-Tachycardia Pacing or Shock) Through Week 24||Randomization up to 24 weeks|Participants in the Full Analysis Set-ICD [all participants who were randomized into the study and received at least 1 dose of study medication, restricted to participants who had at least 1 postbaseline ICD/cardiac resynchronization therapy-defibrillator (CRT-D) interrogation] with available data were analyzed.|||events||Standard Deviation|Mean
2606118|NCT02104505|Secondary|Mucociliary Clearance as Affected by Gamma Tocopherol|On day 11 of treatment (approximately 6 hours after the daily dose) with placebo or gamma tocopherol, a whole lung region of interest (ROI) bordering the right lung was used to estimate (by computer analysis) whole lung retention of inhaled radiolabeled particles. This was performed by measuring the labeled particle counts over a 2 hour period and determining the fraction of initial particle counts remaining. From this data, we determined the percentage of labeled particles cleared from the lung during the 2 hour observation period.|after 11 days of gamma tocopherol or placebo treatment|Due to the crossover study design, only participants who completed both arms of the study were included in the analysis.|||% of labeled particles cleared from lung||Standard Deviation|Mean
2606119|NCT02104505|Secondary|Mucociliary Clearance (MCC) Associated With CCRE Challenge as Affected by Gamma Tocopherol|On day 14 of treatment (approximately 6 hours after the final dose) with placebo or gamma tocopherol, a whole lung region of interest (ROI) bordering the right lung was used to estimate (by computer analysis) whole lung retention of inhaled radiolabeled particles. This was performed by measuring the labeled particle counts over a 2 hour period and determining the fraction of initial particle counts remaining. From this data, we determined the percentage of labeled particles cleared from the lung during the 2 hour observation period.|after 14 days of gamma tocopherol or placebo treatment|Due to the crossover design of the study, only participants who completed both arms of the study were included in the analysis.|||% of labeled particles cleared from lung||Standard Deviation|Mean
2606120|NCT02104505|Secondary|Chronic Eosinophilic Airway Inflammation as Affected by Gamma Tocopherol|The sputum eosinophils were measured at baseline (immediately prior to dosing) and again after 14 days of treatment (approximately 8 hours after the final dose) with placebo or gamma tocopherol. The outcome is to compare sputum eosinophils per mg before and after gamma tocopherol treatment.|after 14 days of gamma tocopherol or placebo treatment|Since this study employs a crossover design, only participants who completed both arms of the study were included in the final analysis.|||eosinophils per mg sputum||Standard Deviation|Mean
2606121|NCT02104505|Primary|Comparison of Change in Sputum Percent Neutrophils (PMN)s Following Inhaled Clinical Center Reference Endotoxin (CCRE) Challenge as Affected by Gamma Tocopherol|In asthmatic individuals, exposure to CCRE is expected to increase PMNs in the sputum. The sputum PMNs were measured at baseline (immediately prior to dosing) and again on day 14 of treatment (approximately 8 hours after the final dose) with placebo or gamma tocopherol. The outcome is to compare the change in PMNs from baseline to post treatment after exposure to CCRE|after 14 days of gamma tocopherol or placebo treatment|Since this study employed a crossover design, only participants who completed both arms of the study were included in the analysis.|||change in percentage of PMNs in sputum||Standard Deviation|Mean
2606122|NCT02104427|Secondary|the Pharmacodynamics (PD) Following Treatment With TG-0054 When Combined With G-CSF|determine circulating CD34+ cell counts in peripheral blood|Day 5 (1st leukapheresis session) to Day 6 (2nd leukapheresis session)|There were 5 patients who achived target number of CD34+ cells (>=5.0*10^6 cells/kg) within two leukapheresis sessions and therefore didn't undergo addtional sessions. Among 7 patients who undergone 6 sessions, there were 1 patient didn't collect blood sample at 4h, 6h post-infusion and post-leukapheresis, and 1 patient 6h post-infusion not done.|||cells/µL||Full Range|Median
2606123|NCT02104427|Secondary|Proportion of Patients Who Mobilized the Targeted Total Number of CD34+ Cells (≥6.0 x 10^6 Cells/kg) Within 5 Leukapheresis Sessions|The secondary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells ≥6.0 x 10^6 cells/kg was collected within 5 leukapheresis sessions. Each patient's CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) 5 leukapheresis sessions.|Day 5 to Day 9|There were total 9 MM patients and 3 NHL or HD patients . A MM patient was treated with Revlimid, Following 2 leukapheresis sessions, a cumulative total of 0.18 x 10^6 cells/kg were collected. PI and Medical Monitor didn't feel that further leukapheresis sessions would achieve more cells, so the patient didn't have additional sessions.|||Proportion of patients||95% Confidence Interval|Number
2606139|NCT02104141|Secondary|Mean Oswestry Disability Index|The Oswestry Disability Index (ODI) is and index to quantify disability for low back pain. There are 50 possible points which are multiplied by 2 to arrive at a percentage score. Zero is equated with no disability and 100 is the maximum disability possible|12 months after device implantation||||score on a scale||Standard Deviation|Mean
2606198|NCT02103114|Secondary|Difference in the Median of the D Dimer of the Control and ATIII Groups at T1, T5, T6 and T7|Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the median of the D dimer of the control and ATIII groups at T1 (Baseline), T5 (Arrival in Intensive Care Unit), T6 (Post-Operative Day 2) and T7 (Post-Operative Day 4).|T1, T5, T6 and T7||||mcg/ml||Inter-Quartile Range|Median
2606124|NCT02104427|Secondary|Proportion of Patients From Whom a Total Number of CD34+ Cells ≥2.5 x 10^6 Cells/kg Was Collected Within the First 4 Leukapheresis Sessions|The secondary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells ≥2.5 x 10^6 cells/kg was collected within the first 4 leukapheresis sessions. Each patient's CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) the first 4 leukapheresis sessions.|Day 5 to Day 8|There were total 9 MM patients and 3 NHL or HD patients . A MM patient was treated with Revlimid, Following 2 leukapheresis sessions, a cumulative total of 0.18 x 10^6 cells/kg were collected. PI and Medical Monitor didn't feel that further leukapheresis sessions would achieve more cells, so the patient didn't have additional sessions.|||Proportion of patients||95% Confidence Interval|Number
2606125|NCT02104427|Primary|Proportion of Patients From Whom a Total Number of CD34+ Cells ≥5.0 x 10^6 Cells/kg Was Collected Within the First 4 Leukapheresis Sessions|The primary efficacy endpoint was the proportion of patients from whom a total number of CD34+ cells ≥5.0 x 10^6 cells/kg was collected within the first 4 leukapheresis sessions. For the primary efficacy endpoint, each patient's CD34+ cell number was calculated as the sum of CD34+ cell numbers collected from (up to) the first 4 leukapheresis sessions.|Day 5 to Day 8|There were total 9 MM patients and 3 NHL or HD patients . A MM patient was treated with Revlimid, Following 2 leukapheresis sessions, a cumulative total of 0.18 x 10^6 cells/kg were collected. PI and Medical Monitor didn't feel that further leukapheresis sessions would achieve more cells, so the patient didn't have additional sessions.|||Proportion of participants||95% Confidence Interval|Number
2606126|NCT02104414|Secondary|Number of Participants With Urinary Retention||up to 4 days||||Participants|||Count of Participants
2606127|NCT02104414|Secondary|Number of Participants With Pain During Bowel Movements|Number of participants with pain during postoperative bowel movements|Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 days||||Participants|||Count of Participants
2606128|NCT02104414|Secondary|Number of Participants With Postoperative Nausea and Vomiting|Number of participants with postoperative nausea and vomiting episodes|up to 4 days||||Participants|||Count of Participants
2606129|NCT02104414|Secondary|Postoperative Opioid Consumption - Hydromorphone I.V||1 hour and 2 hours post op||||mg||Standard Deviation|Mean
2606130|NCT02104414|Secondary|Number of Oxycodone Tablets Taken|Number of postoperative opioid consumption - oxycodone tablets (5mg each)|up to 4 days||||tablets||Standard Deviation|Mean
2606131|NCT02104414|Primary|Post Operative Pain Control|The primary objective is to evaluate analgesia following local infiltration of 30 mL Exparel or the same volume of 0.25% bupivacaine HCl with epinephrine or normal saline. The intensity of pain will be measured using a numerical rating scale (NRS-11) in which 0 represents no pain, and 10 represents extreme pain.|up to 4 days||||score on a scale||Full Range|Mean
2606132|NCT02104219|Other Pre-specified|Rickets Severity Sale - RSS|The RSS is a 10-point scale, developed for nutritional rickets, that evaluates the degree of metaphyseal cupping and fraying and the proportion of growth plate affected (10 points = severe cupping/fraying, 0 points = absence of cupping/fraying).|Any available data during the period of patients' aged 5 to 15 years, inclusive. Baseline is the earliest available assessment value during the period.|All patients who met all of the inclusion and none of the exclusion criteria were defined as the enrolled population, which was also the analysis population.|||units on a scale||Inter-Quartile Range|Median
2606133|NCT02104219|Secondary|Change in Weight Z-score From Baseline to Last Assessment|Weight measurements were assigned a Z-score which was calculated using the Centers for Disease Control and Prevention (CDC) 2000 growth charts and methodology. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome.|Any available growth data during the period of patients' aged 5 to 15 years, inclusive. Baseline is the earliest available assessment while Post baselines are time points after Baseline during the defined age period.|All patients who met all of the inclusion and none of the exclusion criteria were defined as the enrolled population, which was also the analysis population.|||Z-score||Inter-Quartile Range|Median
2606134|NCT02104219|Secondary|Change in Height Z-score From Baseline to Last Assessment|Height measurements were assigned to Z-scores which were calculated using the Centers for Disease Control and Prevention (CDC) 2000 growth charts and methodology. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome.|Any available growth data during the period of patients' aged 5 to 15 years, inclusive. Baseline is the earliest available assessment while post baselines are time points after Baseline during the defined age period.||||Z-score||Inter-Quartile Range|Median
2606135|NCT02104219|Primary|Radiographic Global Impression of Change - RGI-C|The RGI-C scale is a 7-point ordinal scale that is used to evaluate musculoskeletal characteristics of HPP (eg, metaphyseal fraying, demineralization of distal metaphyses). The scores range from -3 (severe worsening) to +3 (complete or near-complete healing).|Between Baseline (earliest available, complete, and readable x-ray set) and all available, readable post-Baseline x-ray sets during the period of patients' aged 5 to 15 years, inclusive.|Patients diagnosed with juvenile-onset HPP.|||units on a scale||Inter-Quartile Range|Median
2606136|NCT02104180|Primary|Pain Intensity at Removal of the Primary Dressing, Evaluated by the Subject Just After Removal|"Pain intensity experienced by subjects associated to removal of each study primary dressings during the care, assessed at of the Cross-over Period on a visual analogue scale (VAS). The VAS was provided as a 100 mm, non-graduated horizontal line, with extremities indicating  no pain  (0) and  extreme pain  (100). The subject responded by drawing a vertical line to assess the pain intensity he/she experienced at the time of removal of the primary wound dressing."|at the time of dressing removal on Day 2 (Visit 2) and Day 4 (Visit 3)|Per protocol|||units on a scale: 0-100 mm||Standard Deviation|Mean
2606137|NCT02104167|Secondary|Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain|NDI is a standard instrument for measuring self-rated disability due to neck pain. It is scored from 0-50, with results multiplied by 2 to arrive at a percentage. Lowest scores represent no disability, high scores represent worse disability. A VAS is a measurement instrument for pain that measures the degree across a continuum or straight line. The endpoints define extreme limits, from 0-10, with 0 representing no pain and 10 severe pain.|12 months (Last available visit) post surgery|Operated Subjects|||Units on a Scale||Full Range|Mean
2606140|NCT02104141|Primary|Number of Participants With Fusion|Fusion was assessed utilizing both AP and flexion/extension radiographs. Fusion was noted when all three of the criteria were present: 1) presence of bridging bone as identified by radiography, 2)Less than 5 degrees of segmental motion on flexion/extension radiographs, and 3) Less than 3 mm of A/P translation on flexion/extension radiographs|12 months after device implantation||||Participants|||Count of Participants
2606141|NCT02103855|Secondary|Pancreas Transplant Function as Measured by Fasting Serum Glucose Level.|Fasting Serum Glucose level measured at 1 year after conversion from Tacrolimus to Belatacept.|1 Year|4 subjects who completed 1 year of Belatacept.|||mg/dl||Standard Deviation|Mean
2606142|NCT02103855|Secondary|Change From Baseline Serum Hemoglobin A1c|Pancreas Transplant Function was measured by assessing change in Pre HbA1c to Post HbA1c at1 year after conversion.|Baseline and 1 year||||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2606143|NCT02103855|Secondary|Number of Participants With Pancreas Transplant Rejection|Pancreas Rejection as measured by serum amylase, serum lipase.|1 year||||Participants|||Count of Participants
2606144|NCT02103855|Primary|Serum Creatinine at Year 1|Serum Creatinine measured at 1 year after conversion from Tacrolimus to Belatacept.|1 year|4 subjects who completed 1 year of Belatacept were analyzed.|||mg/dl||Standard Deviation|Mean
2606145|NCT02103855|Primary|Change From Baseline in Serum Estimated Glomerular Filtration Rate (eGFR)|Change in serum eGFR from baseline to 1 year following conversion from tacrolimus to belatacept|Baseline and 1 year||||ml/min/1.73m2||Standard Deviation|Mean
2606146|NCT02103608|Primary|1. Comparison of Hair Counts Before Treatments to 4 and 12 Weeks Follow up Visits.|Hair count is going to be preformed and base line and compare with the count at 4 weeks and 12 weeks. % of hair reducation is going to be calculated.|4 weeks and 12 weeks post treatment|Individuals who could benefit from hair reduction|||percentage of hair reduction||Standard Deviation|Mean
2606147|NCT02103439|Secondary|Biochemical Response|Proportion of patients in each group with alanine aminotransferase level ≤ upper normal limit after 12 weeks of therapy|12 weeks||||percentage of patients|||Number
2606148|NCT02103439|Primary|Early Virological Response in Patients With Different Hepatitis C Virus Genotypes|Proportion of randomized patients with different Hepatitis C Virus (HCV) genotypes achieving early virologic response - negative polymerase chain reaction result for HCV ribonucleic acid (< 15 IU/ml) or ≥ 2log10 decrease of viral load after 12 weeks of study treatment|12 weeks||||percentage of patients|||Number
2606149|NCT02103439|Secondary|Viral Breakthrough|Proportion of patients in each groups with level of Hepatitis C Virus ribonucleic acid > 15 IU/ml after Hepatitis C Virus ribonucleic acid was not present or Hepatitis C Virus ribonucleic acid was increased by more than 1log10 from baseline at 4 or 12 weeks of treatment|screening data and at 4 or 12 weeks of treatment.||||percentage of patients|||Number
2606150|NCT02103439|Secondary|Rapid Virological Response in Patients With Different Hepatitis C Virus Genotypes|Proportion of randomized patients with different Hepatitis C Virus (HCV) genotypes achieving rapid virological response - negative polymerase chain reaction result for HCV ribonucleic acid (< 15 IU/ml) after 4 weeks of treatment|4 weeks||||percentage of patients|||Number
2606151|NCT02103439|Secondary|Rapid Virological Response|Proportion of randomized patients achieving rapid virologic response - negative polymerase chain reaction result for Hepatitis C Virus ribonucleic acid (< 15 IU/ml) after 4 weeks of treatment|4 weeks||||percentage of patients|||Number
2606152|NCT02103439|Primary|Early Virological Response|Proportion of randomized patients achieving early virologic response - negative polymerase chain reaction result for Hepatitis C Virus ribonucleic acid (< 15 IU/ml) or ≥ 2log10 decrease of viral load after 12 weeks of study treatment|12 weeks||||percentage of patients|||Number
2606153|NCT02103309|Secondary|Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports)|"The participant rated the lens wearing conditions and visual performance of the contact lenses during ball sports on a 10-point scale, where 10=Agree and 1=Disagree. Overall Vision was rated with 10=Excellent and 1=Poor. Both eyes contributed to the mean."|After 1 week of wear|This analysis population includes all enrolled participants minus missing data.|||units on a scale||Standard Deviation|Mean
2606154|NCT02103309|Secondary|Average Subjective Ratings Score (Lens Handling and Overall Vision)|The participant rated the handling and overall vision of the contact lenses on a 10-point scale, where 10=Excellent and 1=Poor. Both eyes contributed to the mean.|After 1 week of wear|This analysis population includes all enrolled participants minus missing data.|||units on a scale||Standard Deviation|Mean
2606155|NCT02103309|Secondary|Mean Investigator-Rated Lens Fit|Lens fit was assessed by the investigator and rated on a 5-point scale with -2=Unacceptable tight fit, -1=Acceptable tight fit, 0=Optimal, 1=Acceptable loose fit, and 2=Uacceptable loose fit. Both eyes contributed to the mean.|After 1 week of wear|This analysis population includes all enrolled participants minus missing data.|||units on a scale||Standard Deviation|Mean
2606156|NCT02103309|Primary|Mean Investigator-Rated Lens Centration|Lens centration was assessed by the investigator using slit-lamp microscopy and rated on a 5-point scale, where 0=Optimal and 4=Severe decentration. Both eyes contributed to the mean.|After 1 week of wear|This analysis population includes all enrolled participants minus missing data.|||units on a scale||Standard Deviation|Mean
2606157|NCT02103270|Secondary|Passing the DBPCFC to Peanut at Week 130|Secondary endpoint: Passing the DBPCFC to peanut at 130 weeks|Week 130||||participants|||Number
2606158|NCT02103270|Primary|Passing the Week 117 DBPCFC to Peanut|Number of Participants with No Clinical Reactivity to Peanuts|Week 117 - Number of participants with no clinical reactivity to peanuts||||participants|||Number
2606159|NCT02103218|Other Pre-specified|Communication About Sex Self-Efficacy Scale|Communication about Sex Self-Efficacy Scale. The theoretical minimum and maximum scores are min=12 and max=60. Higher scores indicate greater self-efficacy (better outcome).|12 months|Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=48 mothers for Risky sex prevention and n=54 mothers for Health behaviors.|||score on a scale||Standard Error|Least Squares Mean
2606175|NCT02103218|Primary|Sex With Multiple Partners, Ever|Sex with multiple partners, ever|12 months|Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.|||logistic GEE predicted probability as %||Standard Error|Least Squares Mean
2606160|NCT02103218|Other Pre-specified|Maternal Monitoring Scale (Mother)|Maternal Monitoring Scale (Mother). The theoretical minimum and maximum values are min=8 and max=40. A higher value indicates greater maternal monitoring which is a better outcome.|12 months|Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=48 mothers for Risky sex prevention and n=54 mothers for Health behaviors.|||score on a scale||Standard Error|Least Squares Mean
2606161|NCT02103218|Other Pre-specified|Mother Adolescent Communication: Open Family Communication (Mother)|Mother Adolescent Communication: Open Family Communication (Mother). The theoretical minimum and maximum values are min=10 and max=50. A higher value indicates greater mother-adolescent open family communication which is a better outcome.|12 months|Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=48 mothers for Risky sex prevention and n=54 mothers for Health behaviors.|||score on a scale||Standard Error|Least Squares Mean
2606162|NCT02103218|Secondary|Sexual Assertiveness: Prevent|Sexual Assertiveness Prevent subscale. The theoretical minimum and maximum scores are min=6 and max=30. Higher scores indicate greater assertiveness in taking measures to prevent pregnancy (better outcome).|12 months|Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.|||score on a scale||Standard Error|Least Squares Mean
2606163|NCT02103218|Secondary|Sexual Assertiveness: Refusal|Sexual Assertiveness Refusal subscale. The theoretical minimum and maximum scores are min=6 and max=30. Higher scores indicate greater assertiveness in refusing sexual activity (better outcome).|12 months|Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.|||score on a scale||Standard Error|Least Squares Mean
2606164|NCT02103218|Secondary|Empowerment: Personal|Empowerment Scale: Personal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater personal empowerment.|12 months|Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.|||score on a scale||Standard Error|Least Squares Mean
2606165|NCT02103218|Secondary|Empowerment: Relationship|Empowerment Scale: Interpersonal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater influence over a partner.|12 months|Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.|||score on a scale||Standard Error|Least Squares Mean
2606166|NCT02103218|Secondary|Empowerment: Interpersonal|Empowerment Scale: Interpersonal. The theoretical minimum and maximum values are min=4 and max=20. A higher value indicates greater personal influence on relationship decisions.|12 months|Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.|||score on a scale||Standard Error|Least Squares Mean
2606167|NCT02103218|Secondary|Racial Pride|Racial Pride Scale. The theoretical minimum and maximum values are min=7 and max=28. A higher value indicates stronger feelings of racial pride which is a better outcome.|12 months|Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.|||score on a scale||Standard Error|Least Squares Mean
2606168|NCT02103218|Secondary|Rosenberg Self-Esteem|Rosenberg Self-Esteem Scale. The theoretical minimum and maximum values are min=10 and max=40. A higher value indicates higher self-esteem which is a better outcome.|12 months|Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.|||score on a scale||Standard Error|Least Squares Mean
2606169|NCT02103218|Secondary|Maternal Monitoring Scale (Girl)|Maternal Monitoring Scale (Girl). The theoretical minimum and maximum values are min=8 and max=40. A higher value indicates greater maternal monitoring which is a better outcome.|12 months|Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.|||score on a scale||Standard Error|Least Squares Mean
2606170|NCT02103218|Secondary|Mother-Adolescent Communication: Open Family Communication (Girl)|Mother-Adolescent Communication: Open Family Communication (Girl). The theoretical minimum and maximum values are min=10 and max=50. A higher value indicates greater mother-adolescent open family communication which is a better outcome.|12 months|Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.|||score on a scale||Standard Error|Least Squares Mean
2606171|NCT02103218|Secondary|Mother-Teen Sexual Risk Communication|Mother-Teen Sexual Risk Communication. The theoretical minimum and maximum are min=8 to max=40. Higher scores indicate greater mother-teen communication about sexual risk which is a better outcome.|12 months|Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.|||score on a scale||Standard Error|Least Squares Mean
2606172|NCT02103218|Secondary|Maternal Bond Scale|Maternal Bond Scale. The theoretical minimum and maximum are min=8 to max=40. Higher scores indicate stronger maternal bonds which is a better outcome.|12 months|Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.|||score on a scale||Standard Error|Least Squares Mean
2606173|NCT02103218|Secondary|HIV Knowledge|HIV-Knowledge Questionnaire for Adolescent Girls. The theoretical minimum and maximum values are min=0 and max=18. Higher scores indicate higher HIV knowledge which is a better outcome.|12 month|Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.|||score on a scale||Standard Error|Least Squares Mean
2606174|NCT02103218|Primary|Drugs/Alcohol Use During Sex, Past 3 Months|Drugs/Alcohol use during sex, past 3 months|12 months|Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.|||logistic GEE predicted probability as %||Standard Error|Least Squares Mean
2606654|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein|Measured using MSD|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
2606177|NCT02103218|Primary|Adolescent Sexual Activity Index|Adolescent Sexual Activity Index (Female). The theoretical minimum and maximum values are min=0 and max=10 (Hansen, Paskett, & Carter, 1999). A higher index value indicates more activity (worse outcome).|12 months|Analyses were performed after multiple imputation for missing data. Number at 12 months before imputation were n=46 for Risky sex prevention and n=51 for Health behaviors.|||score on a scale||Standard Error|Least Squares Mean
2606178|NCT02103114|Secondary|Length of Time to Delayed Sternal Closure Measured in Days|Study the safety profile of dosing the ATIII by monitoring the length of time to delayed sternal closure measured in days|Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4)||||days||Standard Deviation|Mean
2606179|NCT02103114|Secondary|Incidence (Number) of Newly Diagnosed Intracranial Hemorrhage|Study the safety profile of dosing the ATIII by monitoring the incidence (number) of newly diagnosed intracranial hemorrhage|Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4)||||participants|||Number
2606180|NCT02103114|Secondary|Incidence of New Onset Renal Failure, Defined by Stage 3 of the AKIN Criteria|"Study the safety profile of dosing the ATIII by monitoring the incidence of new onset renal failure, defined by stage 3 of the Acute Kidney Injury Network (AKIN) criteria.~Serum creatinine increase ≥26.5 μmol/l (≥0.3 mg/dl) or increase to 1.5-2.0-fold from baseline, urine output <0.5 ml/kg/h for 6 hours~Serum creatinine increase >2.0-3.0-fold from baseline, urine output <0.5 ml/kg/h for 12 hours~Serum creatinine increase >3.0-fold from baseline or serum creatinine ≥354 μmol/l (≥4.0 mg/dl) with an acute increase of at least 44 μmol/l (0.5 mg/dl) or need for Renal replacement therapy (RRT), urine output <0.3 ml/kg/h for 24 h or anuria for 12 hours or need for RRT"|Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4)||||count of participants|||Number
2606181|NCT02103114|Secondary|Incidence (Number) of Thrombotic Events Documented|Study the safety profile of dosing the ATIII by monitoring the incidence (number) of thrombotic events documented.|Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4)||||events|||Number
2606182|NCT02103114|Secondary|Incidence of Mediastinal Exploration Within 24 Hours Postoperatively|Study the safety profile of dosing the ATIII by monitoring the incidence of mediastinal exploration within 24 hours postoperatively|Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4)||||count of participants|||Number
2606183|NCT02103114|Secondary|Incidence of Extracorporeal Membrane Oxygenation (ECMO) Support Within 24 Hours Postoperatively|Study the safety profile of dosing the ATIII by monitoring the incidence of extracorporeal membrane oxygenation (ECMO) support within 24 hours postoperatively.|Baseline (intraoperatively) (Time 1) to Time 7 (Post OP Day 4)||||number|||Number
2606184|NCT02103114|Secondary|Length of Post Operative Ventilation in Days|Length of post operative ventilation in days|ICU arrival (Time 5) to Time 7 (Post-Operative Day 4)||||days||Standard Deviation|Mean
2606185|NCT02103114|Secondary|Total Dose of Recombinant Factor 7a (VIIa) Used Intraoperatively|Total Dose of rescue recombinant factor 7a (VIIa) used intraoperatively|Intraoperatively||||mcg||Standard Deviation|Mean
2606186|NCT02103114|Secondary|Number of Total Blood Product Units Transfused 24-hours Post-operatively by Group|Number of total blood product units (including packed Fresh frozen plasma units, Platelet Units, cryo-precipitate units, and Red Blood Cell units) transfused 24 hours post-operatively for each group (not total units transfused for each subject)|24 Hours Post-Operatively||||Units|||Number
2606187|NCT02103114|Secondary|Number of Total Blood Product Units Transfused by Type 24-hours Post-operatively by Group|Number of packed Fresh frozen plasma units, Platelet Units, cryo-precipitate units, and Red Blood Cell units transfused 24 hours post-operatively for each group (not total units transfused for each subject)|24 Hours Post-Operatively|Unable to be calculated accurately as blood products given in CPB prime were only designated in Units administered and not mls (no record of how many mls present in each unit). Therefore unable to back calculate total mls given from start of surgery to 24 hours postop|||Units|||Number
2606188|NCT02103114|Secondary|Chest Tube Output (Protamine Time Plus 24 Hours) in Milliliters|Chest Tube output (protamine time plus 24 hours) in milliliters|protamine time plus 24 hours||||milliters||Inter-Quartile Range|Median
2606189|NCT02103114|Secondary|Volume of Postoperative Blood Loss|Volume of postoperative blood loss from 10min post protamine administration to 24 hour post protamine administration- (ml/kg)|From 10min post protamine administration to 24 hour post protamine administration||||ml/kg||Standard Deviation|Mean
2606190|NCT02103114|Secondary|Incidence of Recombinant Factor 7a (VIIa) Use Intraoperatively|Incidence of Recombinant Factor 7a (VIIa) Use Intraoperatively|Baseline (Intraoperatively)||||count of participants|||Number
2606191|NCT02103114|Secondary|Total Volume of Fresh Frozen Plasma Given Prior to CPB|Total volume of Fresh Frozen Plasma given prior to CPB, including the pump prime (ml/kg)|Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4)||||ml/kg||Standard Deviation|Mean
2606192|NCT02103114|Secondary|Time From Protamine Administration to Skin Dressing|Time from protamine administration to skin dressing|Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4)||||minutes||Inter-Quartile Range|Median
2606193|NCT02103114|Secondary|Total Volume of Blood Products While on CPB|Total volume of blood products exposed intraoperatively including the pump prime (ml/kg)|Baseline (intraoperatively) (Time 1) to before termination of bypass (Time 4)||||mls||Standard Deviation|Mean
2606194|NCT02103114|Secondary|Protamine Dose Determined by Hemostasis Management System Machine (mg/kg)|Protamine dose determined by Hemostasis Management system machine (mg/kg)|T1 (Baseline) to T5 (Arrival in ICU)||||mg/kg||Inter-Quartile Range|Median
2606195|NCT02103114|Secondary|Total Dose of Heparin While on Cardiopulmonary Bypass|Total dose of Heparin while on Cardiopulmonary Bypass|T1 (Baseline) to T5 (Arrival in ICU)||||units||Inter-Quartile Range|Median
2606196|NCT02103114|Secondary|Evidence of Decreased Inflammation Represented by a Decrease in Inflammatory Markers in the ATIII Group|Evidence of decreased inflammation represented by a decrease in inflammatory markers in the ATIII group.|Baseline (T1) to Post-Operative Day 4 (T7)|Laboratory testing not performed.||||||
2606197|NCT02103114|Secondary|Residual Heparin at the ICU Arrival Time Point Represented by a Decreased Anti Factor Xa Level.|Evidence of a decreased amount of residual heparin at the Intensive Care Unit arrival time point (T5) represented by a decreased anti factor Xa level.|T5 (Intensive Care Unit Arrival)|In both arms, heparin level was undetectable as Anti factor Xa level was less than or equal to 0.1 IU/ml in all subjects.|||International Units/milliter||Standard Deviation|Mean
2606199|NCT02103114|Secondary|Difference in the Median of the ATIII (Functional Assay) of the Control and ATIII Groups at T4|Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the median of the ATIII (functional assay) of the control and ATIII groups at T4 (just prior to coming off of CPB). Data reported as % Functional Activity, which is calculated as the ability of Antithrombin (AT) to suppress FIIa or FXa in the presence of heparin compared to normograms, and expressed as a percentage.|T4 (just prior to coming off of CPB)||||% Functional Activity||Inter-Quartile Range|Median
2606200|NCT02103114|Secondary|Difference in the Mean the ATIII (Functional Assay) of the Control and ATIII Groups at T1, T2, T3, T5, T6 and T7|Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the mean of the ATIII (functional assay) of the control and ATIII groups at T1, T2, T3, T5, T6 and T7 (Baseline, 30 min after study drug, 30 min on CPB, Arrival in ICU, POD 2, and POD 4). Data reported as % Functional Activity, which is calculated as the ability of Antithrombin (AT) to suppress FIIa or FXa in the presence of heparin compared to normograms, and expressed as a percentage.|T1, T2, T3, T5, T6 and T7||||% Functional Activity||Standard Deviation|Mean
2606201|NCT02103114|Secondary|Difference in the Mean and SD of the Calibrated Automated Thrombography (CAT) Measurements of the Control and ATIII Groups at Times 5-Time 7 (ICU Arrival to Post Operative Day 4)|Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the mean and SD of the Calibrated Automated Thrombography (CAT) measurements of the control and ATIII groups at times 5-Time 7 (ICU arrival to Post Operative Day 4)|ICU arrival (Time 5) to Time 7 (Post-operative Day 4)|The laboratory was unable to perform this blood assay due to technical difficulties and no results were generated.||||||
2606202|NCT02103114|Primary|Difference in the Mean and Standard Deviation (SD) of the Calibrated Automated Thrombography (CAT) Measurements of the Control and ATIII Groups at Time 5 (on Arrival in ICU)|Evidence of decreased activation of the coagulation and fibrinolytic systems represented by a difference in the mean and Standard Deviation (SD) of the Calibrated Automated Thrombography (CAT) measurements of the control and ATIII groups at Time 5 (on arrival in ICU).|Time 5 (on arrival in ICU)|The laboratory was unable to perform this blood assay due to technical issues and no results were generated.||||||
2606203|NCT02103062|Other Pre-specified|Kaplan Meier Estimate of PFS by Investigator Assessment|PFS was measured as time from the date of first dose to the date of disease progression according to RECIST 1.1 or death from any cause, whichever was earlier.|Up to 241 days|Intent-to-treat Population defined as participants who received treatment and met all eligibility criteria|||weeks||95% Confidence Interval|Median
2606204|NCT02103062|Secondary|Number of Participants With Adverse Events|A treatment emergent adverse events (TEAE) was defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. A TESAE is defined as any serious adverse event (SAE) occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug. Safety and Severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0; Severity of AEs were graded (including second primary malignancies) as Grade 1- Mild; Grade 2- Moderate; Grade 3- Severe; Grade 4- Lifethreatening; Grade 5-Fatal;|Time of the first dose of study treatment to 28 days after the last dose of study drug; maximum treatment duration was 24 weeks|Safety population includes all participants who received at least one dose of study treatment|||participants|||Number
2606205|NCT02103062|Secondary|Duration of Response (DOR)|Duration of response was defined as the time from the first tumor assessment when the confirmed CR/PR response criterion was met to the date of disease progression based on investigational assessment following RECIST 1.1.|Up to 241 days|The data from the primary efficacy endpoint met the stopping criteria defined by the Simon 2-stage design, which did not support further assessment of nab-paclitaxel as a monotherapy in the analysis of this group of participants. Duration of response was not analyzed as there were no responders observed in the study.||||||
2606206|NCT02103062|Secondary|Overall Response Rate (ORR)|ORR was defined as the combined incidence of Complete Response (CR) and Partial Response (PR), confirmed no less than 4 weeks after the criteria for response were first met based on RECIST 1.1. Tumor responses were assessed every 2 cycles using RECIST 1.1 and defined as: • Complete response-disappearance of all target lesions • Partial response- At least a 30% decrease in the sum of diameters of target lesions from baseline • Stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for Progressive disease (PD) • Progressive Disease- At least a 20% increase in the sum of diameters of target lesions from nadir.|Up to 241 days|ITT population defined as participants who received treatment and met all eligibility criteria.|||percentage of participants||95% Confidence Interval|Number
2606207|NCT02103062|Secondary|Overall Survival|Overall Survival was the time from the first dose of study drug to patient death from any cause.|Up to 241 days|The data from the primary efficacy endpoint met the stopping criteria defined by the Simon 2-stage design, which did not support further assessment of nab-paclitaxel as a monotherapy in the analysis of this group of participants. The study was stopped early and the analysis of overall survival was not performed.||||||
2606208|NCT02103062|Secondary|Percentage of Participants With Stable Disease for ≥ 8 Weeks, or Complete or Partial Response According to RECIST Version 1.1; Disease Control Rate (DCR)|DCR was defined as the combined incidence of stable disease confirmed CR or PR and stable disease (SD) measured at the Week 8 assessment or later.|At week 8 and later; up to day 241|ITT Population defined as participants who received treatment and met all eligibility criteria|||Percentage of participants||95% Confidence Interval|Number
2606209|NCT02103062|Primary|Progression Free Survival (PFS) Rate as Measured at Week 8|PFS rate was measured by Investigator Assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 from the start of study treatment to disease progression or death from any cause, whichever occurred first.|At week 8 assessment period; up to 56 days|Per the Simon 2-stage design, only 30 participants from Stage 1 (the first 15 participants in the Intent to Treat (ITT) population from each cohort) were included. The ITT population was defined as those who received treatment and met all eligibility criteria; four ineligible participants were excluded based on the protocol deviations/violations|||percentage of participants||95% Confidence Interval|Number
2606655|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein|Measured using MSD|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
2606210|NCT02102932|Secondary|AUC(0-tz) of Metformin|Area under the concentration-time curve of the metformin in plasma over the time interval from 0 up to the last quantifiable data point|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):~The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."|||ng* h/mL||Geometric Coefficient of Variation|Geometric Mean
2606211|NCT02102932|Secondary|AUC(0-tz) of Empagliflozin|Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 up to the last quantifiable data point|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):~The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."|||nmol * h/L||Geometric Coefficient of Variation|Geometric Mean
2606212|NCT02102932|Primary|Cmax for Metformin|Maximum measured concentration of the metformin in plasma|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):~The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2606213|NCT02102932|Primary|Cmax for Empagliflozin|Maximum measured concentration of the empagliflozin in plasma|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):~The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2606214|NCT02102932|Primary|AUC(0-∞) for Metformin|Area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):~The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."|||ng * h/mL||Geometric Coefficient of Variation|Geometric Mean
2606215|NCT02102932|Primary|AUC(0-∞) for Empagliflozin|Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 extrapolated to infinity|1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|"Pharmacokinetic set (PKS):~The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK."|||nmol * h/L||Geometric Coefficient of Variation|Geometric Mean
2606216|NCT02102724|Primary|Change in Markers of Immune Senescence Between Baseline Values and Values After 12 Weeks of Supplementation|Markers of immune senescence will include change in the expression of the senescence markers CD28 and CD57 on the surface of peripheral CD4+ and CD8+ T lymphocytes. We will measure the percentage of CD4+ and CD8+ T lymphocytes that are CD28-/CD57- or CD28-/CD57+. We will subtract the percentage obtained at Week 12 from the baseline percentage to calculate the change scores.|End of 12-Week Supplementation Period|Wilcoxon rank sum tests for intergroup change scores|||percentage of cells||95% Confidence Interval|Mean
2606217|NCT02102490|Secondary|Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score|EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.|Cycle 6 Day 1|All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 data.|||Participants|||Count of Participants
2606218|NCT02102490|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and Metabolites M2 and M20|Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20|Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose|All enrolled participants who received at least one dose of study drug (Abemaciclib) with evaluable Abemaciclib, M2 and M20 pharmacokinetic (PK) data.|||Nanograms*hour/milliliters (ng*h/mL)]||Geometric Coefficient of Variation|Geometric Mean
2606219|NCT02102490|Secondary|Number of Participants With Categorical Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) - Worst Pain Score|A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).|Cycle 6 Day 1|All randomized participants with a baseline and at least 1 post-baseline mBPI-sf data.|||Participants|||Count of Participants
2606238|NCT02102399|Primary|Change in Jitter|"Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds.~Normal values must be < 0.6%."|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)|||percentage of jitter||Standard Deviation|Mean
2606239|NCT02102399|Primary|Change in Fundamental Frequency|The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)|||Hertz (Hz)||Standard Deviation|Mean
2606220|NCT02102490|Secondary|Percentage of Participants With Tumor Response of Stable Disease (SD) for at Least 6 Months, Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate)|Clinical benefit rate defined as percentage of patients with best overall response of CR, PR, or SD with a duration of at least 6 months. CR, PR, or SD were defined using RECIST, v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) *100.|From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)|All enrolled participants who received at least one dose of the study drug.|||Percentage of participants||95% Confidence Interval|Number
2606221|NCT02102490|Secondary|Percentage of Participants With CR, PR or SD (Disease Control Rate [DCR])|Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.|From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)|All enrolled participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2606222|NCT02102490|Secondary|Progression Free Survival (PFS)|PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.|From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months)|All enrolled participants who received at least one dose of study drug. Censored participants: Abemaciclib=35.|||Months||95% Confidence Interval|Median
2606223|NCT02102490|Secondary|Duration of Response (DOR)|DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.|From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months)|All enrolled participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2606224|NCT02102490|Secondary|Overall Survival (OS)|OS defined as the time from first dose date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.|From Date of First Dose until Death Due to Any Cause (Up To 27 Months)|All enrolled participants who received at least one dose of study drug. Censored participants: Abemaciclib=70.|||Months||95% Confidence Interval|Median
2606225|NCT02102490|Primary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])|ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.|From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)|All enrolled participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2606226|NCT02102464|Other Pre-specified|Mean Change in Comfortable Contact Lens Wear Time From Baseline at 1 Month|Subjects reported how long they wore their contact lenses per day (total contact lens wear time) and how long the contact lenses were comfortable (comfortable contact lens wear time). The mean change in comfortable contact lens wear time from Baseline was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving cossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month.|1 Month|Intent to Treat (all randomized subjects)|||hours per day|Eyes|95% Confidence Interval|Mean
2606227|NCT02102464|Other Pre-specified|Mean Change in Dry Eye Questionnaire From Baseline at 1 Month|The mean change in dry eye symptoms from Baseline based on the SPEED questionnaire score was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving cossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month. Dry eye symptoms evaluated were dryness, grittiness or scratchiness; soreness or irritation; burning or watering; and eye fatigue. Symptom frequency and severity were assessed. The SPEED score is the sum of frequency and severity scores with a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms.|1 Month|Intent to Treat (All randomized subjects)|||units on a scale|Eyes|95% Confidence Interval|Mean
2606228|NCT02102464|Other Pre-specified|Mean Change in Meibomian Gland Score From Baseline at 1 Month|The mean change in meibomian gland score from Baseline was also evaluated at 1 Month post-LipiFlow treatment for the LipiFlow and Crossover LipiFlow Groups. The LipiFlow Group was assessed at the 1-Month visit. The Crossover LipiFlow Group was assessed at the 4-Month visit (one month after receiving crossover LipiFlow treatment). There was no planned statistical analysis comparison between the LipiFlow and Crossover LipiFlow groups at 1 Month. To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction.|1 Month|Intent to Treat (All randomized subjects)|||units on a scale|Eyes|95% Confidence Interval|Mean
2606229|NCT02102464|Other Pre-specified|Mean Change in Comfortable Contact Lens Wear Time From Baseline at 3 Months|Subjects reported how long they wore their contact lenses per day (total contact lens wear time) and how long the contact lenses were comfortable (comfortable contact lens wear time). A pre-specified exploratory analysis was to compare the mean change in comfortable contact lens wear time between Baseline and 3 Months for the LipiFlow group vs. untreated control.|3 Months|Intent to Treat (ITT) of all randomized subjects|||hours per day||95% Confidence Interval|Mean
2606230|NCT02102464|Secondary|Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months|The Secondary Endpoint was intended to assess for reduction in dry eye symptoms in symptomatic contact lens after LipiFlow treatment in comparison to an untreated control using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. The Secondary Endpoint was defined as the mean change in SPEED score in the LipiFlow Treatment group compared to Untreated Control group from Baseline to 3 Months. Dry eye symptoms evaluated were dryness, grittiness or scratchiness; soreness or irritation; burning or watering; and eye fatigue. Symptom frequency and severity were assessed. The SPEED score is the sum of frequency and severity scores with a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms.|3 Months|Intent to Treat (ITT) Population of all randomized subjects.|||units on a scale||95% Confidence Interval|Mean
2606231|NCT02102464|Primary|Mean Change in Meibomian Gland Score From Baseline at 3 Months|The Primary Endpoint was intended to assess for improvement in meibomian gland function in symptomatic contact lens wearers after LipiFlow treatment in comparison to an untreated control.The Primary Endpoint was defined as the mean change in meibomian gland score in the LipiFlow Treatment group compared to Untreated Control group from Baseline to 3 Months. To determine the meibomian gland score, secretion characteristics of 15 meibomian glands along the lower eyelid were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/ toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range between 0 and 45. A higher score reflects less meibomian gland dysfunction.|3 Months|Intent to Treat (ITT) Population of all randomized subjects.|||units on a scale|Eyes|95% Confidence Interval|Mean
2606232|NCT02102399|Secondary|Post-treatment Questionnaire (Compliance With Intervention)|"The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their degree of compliance on a 3-point Likert scale (not at all/somewhat; moderate; a lot). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories (moderate/a lot and not at all/somewhat). It was considered compliance the answers moderate and a lot in comparison of not at all/somewhat, considered as no compliance. The results were presented in frequency/percentage of subjects in each intervention."|After 6 weeks of intervention|Between-group analysis|||percentage of subjects|||Number
2606233|NCT02102399|Secondary|Post-treatment Questionnaire (Easier to Talk)|"The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their extent of improvement on a 3-point Likert scale (not at all/somewhat; moderate; a lot). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories (moderate/a lot and not at all/somewhat). The results were presented in frequency/percentage of subjects that answered moderate/a lot in each intervention."|After 6 weeks of intervention|Between-group analysis|||percentage of subjects|||Number
2606234|NCT02102399|Secondary|Post-treatment Questionnaire (Voice Clearer)|"The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their extent of improvement on a 3-point Likert scale (not at all/somewhat; moderate; a lot). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories (moderate/a lot and not at all/somewhat). The results were presented in frequency/percentage of subjects that answered moderate/a lot in each intervention."|After 6 weeks of intervention|Between-group analysis|||percentage of subjects|||Number
2606235|NCT02102399|Primary|Change in GNE|"Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations.~Normal levels > 0.5 dB"|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)|||Decibel (dB)||Standard Deviation|Mean
2606236|NCT02102399|Primary|Change in Noise|Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels < 2.5 dB|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)|||Decibel (dB)||Standard Deviation|Mean
2606237|NCT02102399|Primary|Change in Shimmer|Shimmer measures the amplitude perturbations, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds. Normal values < 6.5%|Baseline, 6 weeks||||percentage of shimmer||Standard Deviation|Mean
2606901|NCT02096003|Secondary|Pain Score|Assess pain scores on a scale of 1-5, with higher score indicating more pain.|at 24 hours||||score on a scale||Full Range|Mean
2606240|NCT02102399|Primary|Change in Voice Handicap Index (VHI-10)|The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values > 11.|Baseline, 6 weeks|Between-group analysis (mean difference posttest minus pretest)|||units on a scale||Standard Deviation|Mean
2606241|NCT02102399|Primary|Acoustic Analysis (GNE) 2|"Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations.~Normal levels > 0.5 dB"|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||Decibel (dB)||Standard Deviation|Mean
2606242|NCT02102399|Primary|Acoustic Analysis (Noise) 2|Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels < 2.5 dB|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||Decibel (dB)||Standard Deviation|Mean
2606243|NCT02102399|Primary|Acoustic Analysis (Shimmer) 2|"The shimmer measures the amplitude's disturbance, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds.~Normal values < 6.5%."|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||percentage of shimmer||Standard Deviation|Mean
2606244|NCT02102399|Primary|Acoustic Analysis (Jitter) 2|"Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds.~Normal values must be < 0.6%."|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||percentage of jitter||Standard Deviation|Mean
2606245|NCT02102399|Primary|Acoustic Analysis (Fundamental Frequency) 2|The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||Hertz (Hz)||Standard Deviation|Mean
2606246|NCT02102399|Primary|Voice Handicap Index (VHI-10) 2|The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values > 11.|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||units on a scale||Standard Deviation|Mean
2606247|NCT02102399|Primary|Acoustic Analysis (GNE)|"Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations.~Normal levels > 0.5 dB"|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||Decibel (dB)||Standard Deviation|Mean
2606248|NCT02102399|Primary|Acoustic Analysis (Noise)|Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels < 2.5 dB|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||Decibel (dB)||Standard Deviation|Mean
2606249|NCT02102399|Primary|Acoustic Analysis (Shimmer)|"The shimmer measures the amplitude's disturbance, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds.~Normal values < 6.5%."|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||percentage of shimmer||Standard Deviation|Mean
2606250|NCT02102399|Primary|Acoustic Analysis (Jitter)|"Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds.~Normal values must be < 0.6%."|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||percentage of jitter||Standard Deviation|Mean
2606251|NCT02102399|Secondary|Post-treatment Questionnaire (Voice Symptoms Improvement)|"The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their extent of improvement on a 3-point Likert scale (not at all/somewhat; moderate; a lot). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories (moderate/a lot and not at all/somewhat). The results were presented in frequency/percentage of subjects that answered moderate/a lot in each intervention."|After 6 weeks of intervention|Between-group analysis|||percentage of participants|||Number
2606252|NCT02102399|Primary|Acoustic Analysis (Fundamental Frequency)|The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||Hertz (Hz)||Standard Deviation|Mean
2606304|NCT02101281|Secondary|Change From Baseline in Tear Film Osmolarity|Values of tear film osmolarity and their changes from baseline (screening visit) are summarised by eye (study eye and non study eye) and evaluation visit and stratified by severity level. Only study eye's results are reported hereunder.|Changes from baseline up to day 56±4|FAS: all enrolled patients, who received at least one dose of the IMP. This analysis set was used for the efficacy analysis.|||mOsm/L||Standard Deviation|Mean
2606253|NCT02102399|Primary|Voice Handicap Index (VHI-10)|The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values > 11.|Baseline, 6 weeks|Within-group analysis (pretest vs. posttest)|||units on a scale||Standard Deviation|Mean
2606254|NCT02102230|Primary|Change in Objective Sleep Quality Over Time|Objective sleep quality will be measured via actigraphy|2-weeks post-quit, 4-weeks post-quit, 6-months post-quit||||Participants|||Count of Participants
2606255|NCT02102230|Primary|Change in Self-reported Sleep Quality Over Time|Self-reported sleep quality will be measured using the Consensus Sleep Diary|2-weeks post-quit, 4-weeks post-quit, 6-months post-quit||||Participants|||Count of Participants
2606256|NCT02102230|Primary|Point Prevalence Abstinence Over the Three Post-quit Attempt Assessments|point prevalence abstinence will be assessed using the Timeline Follow-back measure for cannabis count of number abstinent|2-weeks post-quit, 4 weeks post-quit, 6-months post-quit|All participants were considered analyzed by the intent to treat principle, but less than the overall number analyzed contributed data in all three arms. One Placebo participant missing at week 2 rejoined at week 4 and week 6.|||Participants|||Count of Participants
2606257|NCT02102230|Primary|Change in Cannabis Use Frequency Over Time|Measures will include the Timeline Followback for cannabis. All of these measures are standard 7-day point prevalence estimates. In other words, the baseline measure is the number of uses in the 7 days prior to the baseline assessment day. The 6-weeks post-baseline is the number of uses in the 7 days prior to the 6-weeks post-baseline day, and so on.|baseline, 6-weeks post-baseline, 2-weeks post-quit, 4 weeks post-quit, 6-months post-quit|Veteran Cannabis Users|||mean uses per period||Standard Deviation|Mean
2606258|NCT02102204|Secondary|Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies|The number of participants who were binding antibody positive post-baseline with a negative or no result at baseline (where baseline for participants previously treated with etelcalcetide is Day 1 of the first study in which they were exposed to etelcalcetide and for participants previously treated with cinacalcet is the ending time point for study 20120360).|Baseline and every 6 months (up to 24 months)|Participants who received at least 1 dose of etelcalcetide in the current study with a post-baseline antibody result during this study|||participants|||Number
2606259|NCT02102204|Secondary|Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters|The Common Terminology Criteria for Adverse Events (CTCAE) grades for laboratory parameter values were defined based on the upper/lower limit of normal from the local laboratories contracted by the study centers.|Baseline to end of treatment; median duration of treatment was 563 days.|Participants who received at least 1 dose of etelcalcetide in the current study (20130213).|||participants|||Number
2606260|NCT02102204|Secondary|Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL|"The percentage of participants with serum corrected calcium (cCa) reported for cumulative time intervals from day 1 through months 6, 12, and 18, using the participant's lowest recorded corrected calcium value during the time interval.~If serum albumin was less than 4.0 g/dL, serum calcium was corrected according to the following formula:~cCa (mg/dL) = total calcium (mg/dL) + (4 - albumin [g/dL])*0.8. If serum albumin was > 4.0 g/dL no correction was made."|From day 1 to months 6, 12, and 18|Participants who received at least 1 dose of etelcalcetide in the current study (20130213) with available data at the beginning of the time interval.|||percentage of participants||95% Confidence Interval|Number
2606261|NCT02102204|Secondary|Percentage of Participants With Serum Phosphorus ≤ the ULN|Percentage of participants with serum phosphorus less than or equal to the upper limit of normal for the assay used.|Months 6, 12, and 18|Participants who received at least 1 dose of etelcalcetide in the current study (20130213) with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
2606262|NCT02102204|Secondary|Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal|The percentage of participants who maintained plasma parathyroid hormone (PTH) levels within the Kidney Disease Improving Global Outcomes (KDIGO) recommended range of not less than 2x the upper limit of normal (ULN) and not greater than 9x the ULN at months 6, 12, and 18, with the ULN based on the reference range of the assay used at the individual clinical site.|Months 6, 12, and 18|Participants who received at least 1 dose of etelcalcetide in the current study (20130213) with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
2606263|NCT02102204|Primary|Number of Participants With Adverse Events|"A serious adverse event is an AE that met at least 1 of the following criteria:~fatal~life threatening~required in-patient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event.~The relationship of each AE to study treatment was assessed by the investigator.~The following AE grading scale was used:~Mild: Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required Moderate: Mild to moderate limitation in activity-some assistance may be needed; no or minimal medical intervention/therapy required Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalization possible Life-threatening: Extreme limitation in activity, significant assistance required, significant medical intervention/therapy required, hospitalization probable."|From the date of first dose of etelcalcetide (in the current study) and up to 30 days after the last dose; median duration of treatment was 563 days.|Participants who received at least 1 dose of etelcalcetide in the current study (20130213).|||participants|||Number
2606277|NCT02101918|Primary|Objective Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1|90% exact confidence interval was constructed for the overall group. Per Response EvaluationCriteria In SolidTumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR,|Through study completion an average of 19 months|Eligible patients with baseline perfusion CT imaging. One patient from moffitt was a screen fail however 21 patients were evaluable for response and toxicity.|||percentage of participants||90% Confidence Interval|Number
2606264|NCT02102100|Primary|Drug Effects Questionnaire (DEQ)- 'Good Drug Effects'|"The Drug Effects Questionnaire (DEQ) is used in studies of acute subjective response (SR) to a variety of substances. The DEQ consists of 11 questions: cooling effect, dislike the sensation, any sensations, feel a drug effect, high, feel stimulated, feel a head rush, like drug effect, dislike any effects, craving a cigarette, and like more of the drug. To calculate the DEQ- 'Good Drug Effects', peak values from post-infusion time points were calculated for the change in the intensity of positive subjective effects as measured with 2 DEQ questions - DEQ question #6 'like drug effect' and DEQ question #11 'would like more of the drug'. Each question was measured on a scale with a minimum score of 0 and a maximum score of 100.The peak values for like and  I want more were averaged to obtain a summary score to represent the feel 'Good Drug Effects' composite factor. DEQ measures were skewed and square root transformations were used. Higher scores indicate more positive effects."|up to 55 minutes post-infusion||||scores on a scale||Standard Error|Least Squares Mean
2606265|NCT02101983|Secondary|Mean Cost Savings||3 months|Data was not collected from the participants for this outcome measure.||||||
2606266|NCT02101983|Secondary|Number of Participants Who Successfully Completed the of Quality of Life Form|Subjects receiving outpatient high dose cytarabine or inpatient high dose cytarabine will complete the European Organization for Research and Treatment of Cancer Quality of Life tool on the last day of each cycle of chemotherapy. It encompasses 5 functional scales, 3 symptom scales and a global health measure. Scores range from 0-100 with higher scores associated with improved quality of life.|3 months|Subjects must have an unequivocal diagnosis of AML in a documented complete remission, age >/= 55 years with a good performance status and adequate renal and hepatic function. Subjects who decline participation as an outpatient will be approached to participate in the quality of life comparison group.|||Participants|||Count of Participants
2606267|NCT02101983|Primary|Number of Participants With Grades 3 to 5 Non-hematologic Toxicity.|To determine the incidence of number of grades 3 to 5 non-hematologic toxicity of high-dose cytarabine for AML consolidation administered in an outpatient setting.|3 months|Subjects with a documented unequivocal diagnosis of AML in complete remission, age >/= 55 years, with good performance status and adequate renal and hepatic function. Subjects who are eligible for standard of care inpatient HiDAC consolidation will be approached to participate in the Quality of Life comparison group.|||Participants|||Count of Participants
2606268|NCT02101918|Other Pre-specified|Tumor Perfusion Parameters at Time of Progression||Up to 1 year|No patients underwent perfusion CT at time of progression, no analysis could not be performed.||||||
2606269|NCT02101918|Other Pre-specified|Change in Participants Parameters|The effect of ziv-aflibercept therapy on post-treatment BF, BV, mean transit time, and PS will be determined. Descriptive statistics of pre and post treatment values will be given. Distribution of pre and post treatment values will be graphed. Treatment induced change in values will be compared using paired-t test. Non-parametric test will be used if appropriate.|Baseline to 4 weeks after treatment|Response rate was too low to power a valid analysis.||||||
2606270|NCT02101918|Other Pre-specified|Post-treatment Change in BV|Continuous parameters in relative change in pCT parameters will be plotted against best relative change in sum of tumor diameters from RECIST 1.1 tumor measurements. Pearson correlation will be used to test statistical significance. Non-parametric test will be used if appropriate.|Baseline to 4 weeks after treatment|Response rate was too low to power a valid analysis.||||||
2606271|NCT02101918|Other Pre-specified|Post-treatment Change in BF|Continuous parameters in relative change in pCT parameters will be plotted against best relative change in sum of tumor diameters from RECIST 1.1 tumor measurements. Pearson correlation will be used to test statistical significance. Non-parametric test will be used if appropriate.|Baseline to 4 weeks after treatment|Response rate was too low to power a valid analysis.||||||
2606272|NCT02101918|Other Pre-specified|Post-treatment Tumor Blood Flow (BF)|Median will be used as cut point for correlation of post-treatment tumor BF (absolute measurement) with response. Response rates will be compared using chi-square test or Fisher's exact test whenever appropriate. Response rates will be compared using chi-square test or Fisher's exact test whenever appropriate.|4 weeks after treatment|Response rate was too low to power a valid analysis.||||||
2606273|NCT02101918|Other Pre-specified|Change in BV|Median will be used as cut point for correlation of post-treatment changes in BV expressed as relative change from baseline with response. Response rates will be compared using chi-square test or Fisher's exact test whenever appropriate. Response profiles will be compared using non-parametric test (Wilcoxon rank sum test).|Baseline to 4 weeks after treatment|Due to the low response rate, data for blood volume were not collected||||||
2606274|NCT02101918|Secondary|Baseline Permeability Surface (PS)|The relationship between response rate and baseline PS will be evaluated. In addition to hypothesis testing using externally generated cut-points, refinement of optimal cut points in baseline PS separating responders and non-responders will be performed. ROC curves will be generated. Response rates of pCT subgroups defined by these cut-points will be compared using chi-square test. Response profiles of pCT subgroups defined by these cut-points will be compared using non-parametric test (Wilcoxon rank sum test).|Baseline|Due to low response rate data were not collected||||||
2606275|NCT02101918|Secondary|Baseline Blood Volume (BV)|The relationship between response rate and baseline BV will be evaluated. In addition to hypothesis testing using externally generated cut-points, refinement of optimal cut points in baseline BV separating responders and non-responders will be performed. Receiver operating characteristic (ROC) curves will be generated. Response rates of perfusion computed tomography (pCT) subgroups defined by these cut-points will be compared using chi-square test. Response profiles of pCT subgroups defined by these cut-points will be compared using non-parametric test (Wilcoxon rank sum test).|Baseline|Due to low response rate data were not collected||||||
2606276|NCT02101918|Secondary|Progression Free Survival (PFS)|Calculated for all eligible participants using the Kaplan Meier method and reported with confidence interval.|Through study completion an average of 19 months||||months||95% Confidence Interval|Median
2606278|NCT02101515|Other Pre-specified|Continuous Positive Airway Pressure or Greater (Neonate) Such as Intubation, Mechanical Ventilation, Nasal Intermittent Positive Pressure Ventilation, High-frequency Oscillatory Ventilation|Number of neonates who required continuous positive airway pressure or greater.|Until neonatal discharge, usually < 5 days||||Participants|||Count of Participants
2606279|NCT02101515|Other Pre-specified|Neonatal Mortality (Neonate)|one neonate was analyzed per mother|early neonatal mortality (within 7 days of birth).||||Participants|||Count of Participants
2606287|NCT02101515|Other Pre-specified|3rd/4th Degree Laceration|"3rd or 4th degree laceration or cervical laceration diagnosed at delivery~Third degree lacerations extend through the fascia and musculature of the perineal body and involve some or all of the fibers of the external anal sphincter (EAS) and/or the internal anal sphincter.~Third degree lacerations are subclassified as follows:~3a: <50 percent of EAS thickness is torn~3b: >50 percent of EAS thickness is torn~3c: IAS is torn (in addition to complete rupture of the EAS)~Fourth degree lacerations involve the perineal structures, EAS, IAS, and the rectal mucosa."|"at time of delivery, 4 hours second stage for Extended 3 hours second stage for Usual"||||Participants|||Count of Participants
2606288|NCT02101515|Other Pre-specified|Transfusion|Any transfusion of packed red blood cells to the mother or any other blood products given.|at time of delivery until maternal discharge, usually < 5 days||||participants|||Number
2606289|NCT02101515|Other Pre-specified|Endometritis|Clinical diagnosis of postpartum endometritis of the mother|at time of delivery until maternal discharge, usually < 5 days||||Participants|||Count of Participants
2606290|NCT02101515|Other Pre-specified|Spontaneous Vaginal Delivery||"at time of delivery, 4 hours second stage for Extended 3 hours second stage for Usual"||||Participants|||Count of Participants
2606291|NCT02101515|Other Pre-specified|Operative Vaginal Delivery||"at time of delivery, 4 hours second stage for Extended 3 hours second stage for Usual"||||Participants|||Count of Participants
2606292|NCT02101515|Secondary|Postpartum Hemorrhage|Number of participants who experienced a postpartum hemorrhage|"at time of delivery, 4 hours second stage for Extended 3 hours second stage for Usual"||||Participants|||Count of Participants
2606293|NCT02101515|Secondary|Number of Newborns With Umbilical Artery pH < 7.10|Umbilical artery pH is a marker for adverse neurological outcomes. Umbilical artery pH <7.10 has been proposed as a threshold for identifying fetuses who might develop pathologic fetal acidosis and fetal injury.|"at time of delivery, 4 hours second stage for Extended 3 hours second stage for Usual"||||Participants|||Count of Participants
2606294|NCT02101515|Primary|Number of Patients Delivered by Cesarean|Number of patients delivered by cesarean delivery for the extended labor group|"At time of delivery, up to 4 hours of the second stage for Extended group and 3 hours for Usual group"||||Participants|||Count of Participants
2606295|NCT02101437|Primary|miRNA|"miRNA-365-3p measure by Roche miRNA kits; PRP(platelet riched plasma) isolated miRNA by isolation Kit, then havest in cDNA synthesis Kit; then perform RT PCR.~."|7 days|"check miRNA expression: Normalized expression level=2 -Ct, which means the more amount of miRNA, the less Ct.~Negative valure indicated expression<1, and calculated after log2; the final was fold change expression of miRNA-365-3p compared to the control sample."|||fold of change||Full Range|Mean
2606296|NCT02101411|Primary|Numbers of Participants With MACE(Major Adverse Cardiac Event) of Study Subjects|MACE(major adverse cardiac event) include: death, myocardial infarction, revascularization.|24 months||||numbers of participants with MACE|||Number
2606297|NCT02101359|Primary|The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment.||Day 0|Modified ITT (mITT) Set: All randomised patients for whom there was evidence they used the study medication, and who satisfied the non-inclusion criterion concerning unauthorized previous and concomitant medications. Patients were assigned to the treatment group as treated.|||percentage of responders|||Number
2606298|NCT02101294|Secondary|Measurement of Increase in Wrist Swelling Following FingerRelief Typing|Before and after the typing session, the subject's wrist was measured. The mean change score of all participants is reported here.|Pre and Post||||centimeters||Standard Deviation|Mean
2606299|NCT02101294|Primary|Length of Time Typing FingerRelief Prior to Experiencing Symptoms of CTS|Subjects were instructed to type until they experienced a change in symptoms, the length of time that the subjected typed until experiencing symptoms was recorded as this outcome measure, averaged across the two typing sessions that were FingerRelief.|Participants will be assessed at each study of 4 sessions, two typing with the traditional QWERTY keyboard and two typing with the experimental device, each typing session will be separated by approximately one week to allow CTS symptoms to subside||||minutes||Standard Deviation|Mean
2606300|NCT02101294|Secondary|Measurement of Wrist Swelling Following Cessation of QWERTY Typing|Before and after typing, the subject's wrists were measured with a tape measure. The change score is reported here.|Participants will be assessed at each study of 4 sessions, two typing with the traditional QWERTY keyboard and two typing with the experimental device, each typing session will be separated by approximately one week to allow CTS symptoms to subside||||centimeters||Standard Deviation|Mean
2606301|NCT02101294|Primary|Length of Time Typing QWERTY Prior to Experiencing Symptoms of CTS (Carpal Tunnel Syndrome)|Subjects were instructed to type until they experienced a change in symptoms, the length of time that the subjected typed until experiencing symptoms was recorded as this outcome measure. Length of time typing at each QWERTY session was averaged across the two sessions to determine Length of time typing QWERTY.|Participants will be assessed at each study of 4 sessions, two typing with the traditional QWERTY keyboard and two typing with the experimental device, each typing session will be separated by approximately one week to allow CTS symptoms to subside||||minutes||Standard Deviation|Mean
2606302|NCT02101281|Secondary|Mean Frequency of Artificial Tears Use|During the treatment with rhNGF at both doses (from day 1 to day 29), and in the follow-up period (from day 29 to day 56) the mean frequency of daily use of artificial tears was measured.|Day 1-Day 8, Day 9-Day 29, Day 30-Day 56 intervals|FAS: all enrolled patients, who received at least one dose of the IMP. This analysis set was used for the efficacy analysis.|||uses per day||Standard Deviation|Mean
2606303|NCT02101281|Secondary|Change From Baseline in Conjunctival Impression Cytology for Goblet Cells' Count|"Four conjunctival impression cytology samples (temporal, nasal, inferior and superior bulbar conjunctiva) for conjunctival goblet cell counts were performed in the worse eye (study eye).~Conjunctival epithelium samples are obtained following the instillation of a preservative-free anaesthetic eye drop by slightly pressing on the bulbar conjunctiva a 0.1 μm cellulose acetate filter. When the disc is removed the apical layers of conjunctival epithelium remain impressed on it.~Cells on the filter are fixed and stained. The final results will be expressed as mean ± SD of 3 consecutive optic fields for each sample.~A higher number of goblet cells indicates a healthier eye."|Baseline, Day 1, Day 8, Day 29 and Day 56|FAS: all enrolled patients, who received at least one dose of the IMP. This analysis set was used for the efficacy analysis.|||cell counts||Standard Deviation|Mean
2606305|NCT02101281|Secondary|Number of Participants With a Change in Fundus Ophthalmoscopy|"This test allows seeing inside the fundus of the eye and other structures using an ophthalmoscope. The fundus examination included assessments of vitreous, macula, retina and optic nerve head for both eyes. Only the results concerning the study eye are reported hereunder.~These structures will be assessed according to the criteria outlined below.~Vitreous The examiner will judge the appearance of the vitreous in the visual axis. Normal: Absence of any opacity Abnormal: Presence of opacity~Macula, (Peripheral) Retina and Optic Nerve Head The examiner will provide a separate assessment of the macular, choroid and peripheral retina Normal: Absence of any structural or vascular change, inflammation, oedema or haemorrhage.~Abnormal: Evidence of any ongoing or previous structural/vascular change, inflammation, oedema or haemorrhage."|Baseline, Day 1, Day 8, Day 29 and Day 56|FAS: all enrolled patients, who received at least one dose of the IMP. This analysis set was used for the efficacy analysis.|||Participants|||Number
2606306|NCT02101281|Secondary|Change From Baseline in Visual Acuity (BCDVA)|"Values of Best-Corrected Distance Visual Acuity (BCDVA) scores were measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) score. The ETDRS charts use letters, or a geometric progression in letter size from line to line, under standardized lighting conditions. The patient starts at the top of the chart, or on the last row where he or she can read all of the letters, and reads down the chart until he or she reaches a row where a minimum of three letters on a line cannot be read. The patient is scored by how many letters could be correctly identified. Therefore, the higher the number of letters the higher the visual acuity.~Changes in the ETDRS score from baseline (screening visit) are summarised by eye (study eye and non study eye) and evaluation visit, and stratified by severity level.~Only study eye's results are reported hereunder."|Baseline, Day 1, Day 8, Day 29 and Day 56|FAS: all enrolled patients, who received at least one dose of the IMP. This analysis set was used for the efficacy analysis.|||letters||Standard Deviation|Mean
2606307|NCT02101281|Secondary|Change From Baseline in Ocular Surface Disease Index (OSDI)|"The OSDI is based on a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The 12 items of the OSDI questionnaire are graded on a 0-4 scale as follows:~Grade 0 = none Grade 1 = some Grade 2 = half Grade 3 = most Grade 4 = all~The total OSDI score was then calculated on the basis of the following formula:~OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4].~Thus, the OSDI total score scales from 0 to 100, with higher scores representing greater disability."|Baseline, Day 1, Day 8, Day 29 and Day 56|FAS: all enrolled patients, who received at least one dose of the IMP. This analysis set was used for the efficacy analysis.|||score on a scale||Standard Deviation|Mean
2606308|NCT02101281|Secondary|Change From Baseline in Intraocular Pressure (IOP)|IOP was performed using either Goldmann applanation tonometry or a handheld applanation tonometer (e.g. Tonopen) after the instillation of a topical anaesthetic. IOP was measured in both eyes after completion of all other slit lamp examinations to avoid potential interference with the other evaluations. Only study eye's results are reported hereunder.|Baseline, Day 1, Day 8, Day 29 and Day 56|FAS: all enrolled patients, who received at least one dose of the IMP. This analysis set was used for the efficacy analysis.|||mmHg||Standard Deviation|Mean
2606309|NCT02101281|Secondary|Change From Baseline in Corneal Sensitivity to Contact (Cochet-Bonnet Aesthesiometry)|"Corneal sensitivity was measured in cm through the Luneau-Cochet-Bonnet aesthesiometer. This contains a thin, retractable, nylon monofilament that extends up to 6 cm in length. Variable pressure can be applied to the cornea by adjusting the monofilament length. The monofilament length ranges from 6 to 0.5 cm. As the monofilament length is decreased the pressure increases from 11 mm/g to 200 mm/g. The filament is retracted incrementally in 0.5 cm until the patient gives a positive reaction indicating that the contact of the monofilament on the cornea has been sensed. The shorter filament lengths indicate decreased corneal sensation. The length of the filament (in cm) at which the patient sensed the contact with the cornea is recorded.~Only study eye's results are reported hereunder."|Baseline, Day 1, Day 8, Day 29 and Day 56|FAS: all enrolled patients, who received at least one dose of the IMP. This analysis set was used for the efficacy analysis.|||cm||Standard Deviation|Mean
2606310|NCT02101281|Secondary|Change From Baseline in Corneal Fluorescein Staining|"Fluorescein staining of the cornea is a methodology to visualize corneal epithelial defects under slit lamp microscopy in patients with suspicious or known Dry Eye Disease (DED). Fluorescein dyed - impregnated paper strips were used. Before placing the strip in the lower fornix of the eye, a drop of sterile saline was added to the strip.~The cornea was divided into five sectors (central, superior, inferior, nasal and temporal), each of which was scored on a scale of 0-3, with a maximal global score of 15.~For a better reading under the slit lamp, no intense illumination beam was used, since it could reduce the contrast and lead to an underestimation of grading.~The lower the score the lower the corneal damage."|Baseline, Day 1, Day 8, Day 29 and Day 56|FAS: all enrolled patients, who received at least one dose of the IMP. This analysis set was used for the efficacy analysis.|||units on a scale||Standard Deviation|Mean
2606311|NCT02101281|Secondary|Change From Baseline in Tear Film Break-Up Time (TFBUT)|"TFBUT was measured by determining the time to tear break-up. The TFBUT was performed after instillation of 5 μl of 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. With the aid of a slit lamp at 10X magnification using cobalt blue illumination, the examiner will monitor the integrity of the tear film, noting the time it takes to form lacunae (clear spaces in the tear film) from the time that the eye is opened after the last blink. The longer the time the better the integrity of the tear film.~Only Study eye's results are reported hereunder."|Baseline, Day 1, Day 8, Day 29 and Day 56|FAS: all enrolled patients, who received at least one dose of the IMP. This analysis set was used for the efficacy analysis|||seconds||Standard Deviation|Mean
2606312|NCT02101281|Secondary|Change From Baseline in Tear Wetting Distance as Determined by Schirmer Tear Test II - Study Eye|The Schirmer test type II (with anaesthesia) was performed to measure aqueous tear secretion following the instillation of a preservative-free anaesthetic eye drop (Oxybuprocaine Chlorhydrate 0.4%). The rounded tip of a standardized paper strip is inserted into the lower fornix of the eye, and the wetted length extending out from the lower lid is recorded after 5 min of eye closure. Both eyes could be tested at the same time. Changes from baseline in values of Schirmer's test type I are summarised by eye and evaluation visit and stratified by severity level. The longer the wetted length the healthier the status of the eye. Only study eye's results are reported hereunder.|Baseline, Day 1, Day 8, Day 29 and Day 56|FAS: all enrolled patients, who received at least one dose of the IMP. This analysis set was used for the efficacy analysis.|||millimeters||Standard Deviation|Mean
2606313|NCT02101281|Secondary|Change From Baseline in Slit Lamp Examination|"SLE grading of the eyelids, lashes, conjunctiva, cornea, lens, iris and anterior chamber was done according to the following scales:~Eyelid - Meibomian glands (evaluation of the central ten Meibomian gland openings in the mid-portion of the upper eyelid):~0, 1, 2, 3 = None, Mild, Moderate, Severe gland plugging Eyelid - Erythema 0, 1, 2, 3,4 = None, Mild, Moderate, Severe, Very severe redness of lid margin and/or skin Eyelid - Oedema 0, 1, 2, 3,4 = None, Mild, Moderate, Severe, Very severe oedema Lashes 0 = Normal~1 = Abnormal Conjunctiva - Erythema 0, 1, 2, 3, 4 = None, Mild, Moderate, Severe erythema Conjunctiva - Oedema 0, 1, 2, 3, 4 = None, Mild, Moderate, Severe, Very severe swelling Lens 0, 1, 2, 3 = No, Mild, Moderate, Severe opacification N/A = Patient with artificial lens Iris 0 = Normal~1 = Abnormal. Anterior Chamber Inflammation 0, 1, 2, 3, = No, Mild, Moderate, Severe, Very severe Tyndall effect~Only the study eye's results are reported hereunder."|Baseline, Day 1, Day 8, Da 29 and Day 56|FAS: all enrolled patients, who received at least one dose of the IMP. This analysis set was used for the efficacy analysis|||units on a scale||Standard Deviation|Mean
2606314|NCT02101281|Secondary|Change From Baseline in Ocular Tolerability (Visual Analogue Scale, VAS)|"A ocular tolerability score was determined using a 100 mm VAS on which 0 meant No symptoms and 100 meant the Worst possible discomfort. The patients subjectively evaluated their ocular symptoms (foreign body sensation, burning or stinging, itching, pain, sticky feeling, blurred vision and photophobia) using the VAS giving the value they were feeling from none to an extreme value.~The ocular symptoms were evaluated by the patients through the scale. Only the study eye's results are reported hereunder."|Baseline, Day 1, Day 8, Day 29 and Day 56|FAS: all enrolled patients, who received at least one dose of the IMP. This analysis set was used for the efficacy analysis|||Units on a scale||Standard Deviation|Mean
2606315|NCT02101281|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs),|The treatment-emergent adverse events were recorded throughout the whole study.|Throughout the study up to day 56|Safety set: all patients who received at least one dose of the IMP. This analysis set was used for the safety analysis|||Participants|||Count of Participants
2606316|NCT02101281|Primary|Change From Baseline in Tear Wetting Distance as Determined by Schirmer Tear Test I - Study Eye|The Schirmer test type I (without anaesthesia) was performed to measure aqueous tear secretion prior to the instillation of any dilating or anaesthetic eye drops. The rounded tip of a standardized paper strip is inserted into the lower fornix of the eye, and the wetted length extending out from the lower lid is recorded after 5 min of eye closure. Both eyes could be tested at the same time. Changes from baseline in values of Schirmer's test type I are summarised by eye and evaluation visit, and stratified by severity level. The longer the wetted length the healthier the status of the eye. Only study eye's results are reported hereunder.|Baseline, Day 1, Day 8, Day 29 and Day 56|FAS subjects:|||millimeters||Standard Deviation|Mean
2606317|NCT02101281|Primary|Change From Baseline in Ocular Surface Vital Staining (National Eye Institute [NEI] Scale)|"The cornea is divided into five sectors (central, superior, inferior, nasal and temporal), each of which is scored on a scale of 0-3, with a maximal score of 15. Both nasally and temporally, the conjunctiva is divided into a superior paralimbal area, an inferior paralimbal area and a peripheral area with a grading scale of 0-3 and with a maximal score of 9 for the nasal and temporal conjunctiva.~Staining was derived as the sum of scores in the various sectors. The higher the total score the more compromised is the ocular surface."|Baseline, Day 1, Day 8, Day 29 and Day 56|FAS subjects: all enrolled patients, who received at least one dose of the IMP. This analysis set was used for the efficacy analysis|||units on a scale||Standard Deviation|Mean
2606318|NCT02101281|Primary|Change From Baseline in Severity of Dry Eye Symptoms (SANDE)|The SANDE is a short questionnaire to evaluate the severity of ocular dryness and/or irritation symptoms. For the assessment, the patients mark on the 100 mm VAS line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left-hand end of the line to the point that the patient marks. The SANDE scores (0-100) will be then evaluated for severity. The higher the score, the worse the outcome.|Baseline, Day 1, Day 8, Day 29 and Day 56|FAS subjects: all enrolled patients, who received at least one dose of the IMP. This analysis set was used for the efficacy analysis|||units on a scale||Standard Deviation|Mean
2606319|NCT02101281|Primary|Change From Baseline in Frequency of Dry Eye Symptoms (SANDE)|The SANDE is a short questionnaire to evaluate the frequency of ocular dryness and/or irritation symptoms. For the assessment, the patients mark on a 100 mm Visual Analogue Scale (VAS) line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The SANDE scores (0-100) will be then evaluated for frequency per day.|Baseline, Day 1, Day 8, Day 29 and Day 56|FAS subjects: all enrolled patients, who received at least one dose of the IMP. This analysis set was used for the efficacy analysis|||Frequency of symptoms per day||Standard Deviation|Mean
2606320|NCT02101190|Primary|Area Under the Curve (AUC0-t)|BIA 9-1067 AUC0-t following a single dose of 50mg BIA 9-1067|pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-dose||||ng.hr/mL||Standard Deviation|Mean
2606321|NCT02101190|Primary|Tmax - Time to Reach Cmax|BIA 9-1067 Tmax following a single dose of 50mg BIA 9-1067|pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-dose||||hours||Full Range|Median
2606322|NCT02101190|Primary|Cmax - Maximum Plasma Concentration of BIA 9-1067|BIA 9-1067 Cmax following a single dose of 50mg BIA 9-1067|pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-dose||||ng/mL||Standard Deviation|Mean
2606323|NCT02101112|Secondary|Relative Bioavailability (Frel) of Apixaban|Frel is calculated using the treatment ratio of AUC(INF) where the denominator is the AUC(INF) of the reference therapy, 10mg of Apixaban (whole tablet).|Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban|||ratio||Geometric Coefficient of Variation|Geometric Mean
2606324|NCT02101112|Secondary|Terminal Plasma Half-life (T-HALF) of Apixaban|Terminal plasma half-life (T-HALF) was derived from plasma concentration versus time data. T-HALF was the time required for one half of the total amount of administered drug to be eliminated from the body.|Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban|||hours||Standard Deviation|Mean
2606325|NCT02101112|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban|Time of maximum observed plasma concentration (Tmax) measured in hours (h)|Days 1, 5 and 9 pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12 24, 36, 48, 60 and 72 hrs post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban|||hours||Full Range|Median
2606326|NCT02101112|Secondary|Number of Participants With Serious Adverse Events, Death, or Discontinuation Due to Adverse Events by Study Completion|Adverse Event (AE) = any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious Adverse Event (SAE)= a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Randomization to May 2014; approximately 6 weeks|All randomized and treated participants|||participants|||Number
2606327|NCT02101112|Primary|Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Concentration [AUC (0-T)] is measured as nanograms multiplied by hours per milliliter (ng*h/mL)|Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban|||ng*h/mL||90% Confidence Interval|Geometric Mean
2606328|NCT02101112|Primary|Adjusted Geometric Mean of Area Under the Plasma Concentration-time Curve (AUC) From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban|Area Under the Plasma Concentration-time Curve (AUC) From Time of Zero Extrapolated to Infinite Time (INF) [AUC (INF)] is measured as nanograms multiplied by hours per milliliter (ng*h/mL)|Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, and 72 hours post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban|||ng*h/mL||90% Confidence Interval|Geometric Mean
2606329|NCT02101112|Primary|Adjusted Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Apixaban|Maximum observed plasma concentration (Cmax) measured in nanograms per milliliter (ng/mL)|Days 1, 5, and 9 predose and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 and 72 hours post dose|All evaluable pharmacokinetic (PK) participants who were treated with apixaban|||ng/mL||90% Confidence Interval|Geometric Mean
2606330|NCT02101021|Secondary|Randomized Treatment Phase: Overall Response Rate|The ORR was defined as the proportion of subjects who achieved a best overall response (BOR) during MMB therapy of complete response (CR) or partial response (PR)|Baseline up to the Last Tumor Assessment Date, up to 3 years|The study was discontinued before initiation of the randomized treatment phase.||||||
2606331|NCT02101021|Secondary|Randomized Treatment Phase: Progression-Free Survival (PFS)|Progression-free survival was defined as the time interval from the first dose of MMB to the earlier of the first documentation of definitive disease progression or death from any cause|Baseline up to the Date of Event or Censoring, up to 3 years|The study was discontinued before initiation of the randomized treatment phase.||||||
2606332|NCT02101021|Secondary|Lead-In Phase: Overall Response Rate (ORR)|The ORR was defined as the proportion of participants who achieved a best overall response (BOR) during MMB therapy of complete response (CR) or partial response (PR) as assessed by RECIST v1.1.|Baseline up to the Last Tumor Assessment Date, up to 3 years|All Enrolled Analysis Set|||Participants|||Count of Participants
2606333|NCT02101021|Secondary|Lead-In Phase: Progression-Free Survival (PFS)|Progression-free survival was defined as the time interval from the first dose of MMB to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression is progression based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria v1.1. Data from survival, non-progressing participants will be censored at the earliest of the time of initiation of anti-tumor therapy other than the study treatment or the last time that lack of definitive disease progression was objectively documented while on study.|Baseline up to the Date of Event or Censoring, up to 3 years|All Enrolled Analysis Set|||Months||Inter-Quartile Range|Median
2606334|NCT02101021|Secondary|Lead-In Phase: Overall Survival (OS)|Overall survival was defined as the time interval from first dose date of MMB to death from any cause|Baseline up to the Date of Death or Censoring, up to 3 years|All Enrolled Analysis Set|||Months||Inter-Quartile Range|Median
2606335|NCT02101021|Primary|Randomized Treatment Phase: Overall Survival (OS)|Overall survival was defined as the time interval from first dose date of MMB to death from any cause|Baseline up to the Date of Death or Censoring, up to 3 years|The study was discontinued before initiation of the randomized treatment phase.||||||
2606336|NCT02101021|Primary|Lead-In Phase: Percentage of Participants Experiencing Treatment-Emergent Dose Limiting Toxicity (DLT) Adverse Events|"Dose limiting toxicities were based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Dose limiting toxicities referred to toxicities experienced during the first 28 days (Cycle 1) of treatment that were judged to be clinically significant and related to study treatment.~No statistical analysis was planned or performed for this endpoint."|Up to 28 Days|DLT-Evaluable Analysis Set: participants in the Safety Analysis Set who completed all treatment and safety procedures through Day 28, inclusive, or experienced a DLT prior to Day 29. Participants in the DLT-Evaluable Analysis Set with available data were analyzed.|||percentage of participants|||Number
2606337|NCT02101008|Secondary|Progression Free Survival||Every 56 days - for up to two years||||days||Standard Deviation|Mean
2606338|NCT02101008|Primary|Overall Response Rate to Treatment of Melanoma With Disulfiram and Chelated Zinc|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scanning of the chest, abdomen and pelvis, or PET/CT scanning.: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Response to treatment will be measured by RECIST evaluation at disease assessment time-points from date of randomization until the date of first documented progression or death from any cause whichever came first (up to five years).||||participants|||Number
2606339|NCT02100969|Secondary|Tolerabililty|Tolerability is assessed as the number of subjects who completed the study and/or did not withdraw due to worsening.|12 weeks from start of SCIg||||Participants|||Count of Participants
2606656|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein|Measured using MSD|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
2606340|NCT02100969|Secondary|Immunoglobulin G (IgG) Antibody Levels|Measure IgG level (mg/dL) between intravenous and subcutaneous study phases. Normal range equals 762-1488 mg/dL.|"Change from Week -10 to Week 0 versus Week 1 to Week 12"|Note: Change in IgG from Week -10 to Week 0 can be assessed for 20 participants. Change in IgG from Week 1 to Week 12 can be assessed for 19 participants.|||mg/dL||Inter-Quartile Range|Median
2606341|NCT02100969|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) - Satisfaction Score|Treatment Satisfaction Questionnaire for Medication (TSQM) - Satisfaction Score measured on a scale of 0 to 100. 0 indicates no treatment satisfaction and 100 indicates highest treatment satisfaction.|Change from Baseline to Week 12|This secondary outcome was recorded for 18 patients. Analysis is done as per the protocol.|||score on a scale||Inter-Quartile Range|Median
2606342|NCT02100969|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) - Effectiveness Score|Treatment Satisfaction Questionnaire for Medication (TSQM) - Effectiveness Score measured on a scale of 0 to 100. 0 indicates no treatment effectiveness satisfaction and 100 indicates highest treatment effectiveness satisfaction.|Change from Baseline to Week 12|This secondary outcome was recorded for 20 patients. Analysis is done as per the protocol.|||score on a scale||Inter-Quartile Range|Median
2606343|NCT02100969|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM) - Convenience Score|Treatment Satisfaction Questionnaire for Medication (TSQM) - Convenience Score measured on a scale of 0 to 100. 0 indicates no treatment convenience satisfaction and 100 indicates highest treatment convenience satisfaction.|Change from Baseline to Week 12|This secondary outcome was recorded for 18 patients. Analysis is done as per the protocol.|||score on a scale||Inter-Quartile Range|Median
2606344|NCT02100969|Secondary|Myasthenia Gravis Composite (MGC) Score|The MGC takes scores from the MG-ADL, the QMG, and combines them will manual muscle testing scores to create the MGC. The scale of this score ranges from 0 - 50 with higher scores meaning a worse outcome or more sever symptoms.|Change from Baseline to Week 12|Here we consider the 21 participants on whom the MG-Composite scores are available for analysis.|||score on a scale||Inter-Quartile Range|Median
2606345|NCT02100969|Secondary|Myasthenia Gravis Quality of Life (MG QOL-15) Scores|MG Quality of Life (QOL)-15: Composite measure of scores from measurement scales. The MG QOL-15 is a questionnaire answered by the patient that asked about different symptoms of MG. The questionnaire consists of 15 questions that are graded on a scale of 0 - 4. The total score has a range of 0 - 60 with a higher score meaning more severe symptoms or a worse outcome.|Change from Baseline to Week 12|Here we consider the 22 participants on whom the MG-ADL scores at either baseline or Week 12 are available for analysis.|||score on a scale||Inter-Quartile Range|Median
2606346|NCT02100969|Secondary|Myasthenia Gravis-specific Activities of Daily Living Scale (MG-ADL) Scores|Myasthenia Gravis-specific Activities of Daily Living scale (MG-ADL): Composite measure of scores from measurement scales. The MG-ADL has a scale of 0 - 24 with 0 being the lowest (no symptoms) and 24 being the highest (most severe symptoms. The MG-ADL is a staff-administered, patient-reported questionnaire that measures 8 commons symptoms of myasthenia gravis and grades them on a scale of 0 - 3.|Change from Baseline to Week 12|Here we consider the 22 participants on whom the MG-ADL scores at either baseline or Week 12 are available for analysis.|||score on a scale||Inter-Quartile Range|Median
2606347|NCT02100969|Primary|Proportion of Patients Whose Quantitative Myasthenia Gravis Scores Are Increased by no More Than 3 Points at the End of the SCIg Treatment Phase|"The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The scale is from 0 - 3 for each item, with 0 meaning normal and 3 is severe. Total score can range from 0 to 39.~Change in MG severity will be measured using the Quantitative Myasthenia Gravis (QMG) Score for Disease severity. The QMG is a validated clinical composite scale. As mentioned in the protocol, our hypotheses are:~H0: Proportion of patients whose QMG scores are increased by more than 3 points at the end of the SCIg treatment phase ≤ 0.65 HA: Proportion of patients whose QMG scores are increased by no more than 3 points at the end of the SCIg treatment phase > 0.65~Thus, analysis of the primary outcome is done as a one-sample Z test of proportions. That is, the QMG is a continuous outcome, but analyses results are reported as proportions."|Change from Baseline to Week 12|23 patients were enrolled in the study. The protocol mentions that only those subjects who have stable QMG in the screening phase will be considered eligible for analyses. In our case 22 out of 23 patients are eligible for the final analyses.|||proportion of participants||95% Confidence Interval|Number
2606348|NCT02100930|Primary|Complete Remission|Disease status is defined by the International Neuroblastoma Response Criteria - Complete response/remission (CR): NED; Partial response/remission: >50% decrease in all disease parameters, exceptbone scan unchanged or improved; no more than 1 positive bone marrow site; Stable disease: <50% decrease in all tumor markers; Progressive disease (PD): new lesion, or >25 % increase in any disease marker.|2 years||||Participants|||Count of Participants
2606349|NCT02100930|Primary|Therapeutic Response|Disease status is defined by the International Neuroblastoma Response Criteria - Complete response/remission (CR): NED; Partial response/remission: >50% decrease in all disease parameters, exceptbone scan unchanged or improved; no more than 1 positive bone marrow site; Stable disease: <50% decrease in all tumor markers; Progressive disease (PD): new lesion, or >25 % increase in any disease marker.|2 years||||Participants|||Count of Participants
2606350|NCT02100839|Secondary|Very Low Density Lipoprotein Cholesterol (VLDL-C) Percent Change|Maximum observed percentage change in VLDL-C level relative to baseline for all time points measured in Parts A or Part B with highest dose, i.e. 3.54 mg/kg.|Part A (SAD): Day 1 to Day 15; Part B (MAD): Day 1 to Day 57||||Max % Change Versus Baseline||Standard Deviation|Mean
2606351|NCT02100839|Primary|Number of Participants Who Incurred Moderate Treatment Emergent Events|"Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.~Safety and tolerability data were reported using descriptive statistics."|Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57||||Number of Participants|||Number
2606902|NCT02096003|Secondary|Time to Initial PCA Use|When does the patient need to use the PCA for the first time? This will be used to assess when morphine and hydromorphone first begin to provide analgesia.|up to 24 hours|data not collected.||||||
2606352|NCT02100839|Primary|Number of Participants Who Incurred Mild Treatment Emergent Adverse Events|"Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.~Safety and tolerability data were reported using descriptive statistics."|Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57||||Number of Participants|||Number
2606353|NCT02100839|Primary|Number of Participants Who Incurred at Least One Treatment Emergent Event|"Safety and tolerability to AEM-28 were evaluated through the assessment of adverse events (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management), vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight (Part B only). Treatment-emergent adverse events were tabulated by treatment. Changes from baseline values in vital signs, ECG, clinical laboratory parameters, physical examination, and body weight (Part B only) were evaluated.~Safety and tolerability data were reported using descriptive statistics."|Part A (SAD): Day -1 to Day 15; Part B (MAD): Day 1 to Day 57||||participants|||Number
2606354|NCT02100826|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||Microgram per milliliter(µg/ml)||Geometric Coefficient of Variation|Geometric Mean
2606355|NCT02100826|Secondary|Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data|||Hours||Standard Deviation|Median
2606356|NCT02100826|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose||Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period|All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data.|||hour*microgram per milliliter(h*μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2606357|NCT02100813|Secondary|Part 2: Participants With Partial Clearance of AKs|Partial clearance of AKs at Week 8 was defined as at least 75% reduction from baseline in AK count.|From baseline to Week 8||||percentage of participants||95% Confidence Interval|Number
2606358|NCT02100813|Secondary|Part 2: Participants With Complete Clearance of AKs|Complete clearance of AKs at Week 8 was defined as a 100% reduction from baseline in AK count.|From baseline to Week 8||||percentage of participants||95% Confidence Interval|Number
2606359|NCT02100813|Primary|Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Lesion Count|Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) in the selected treatment area.|From baseline to Week 8||||percentage of reduction||95% Confidence Interval|Mean
2606360|NCT02100813|Primary|Part 1: Number of Participants Experiencing a Dose-limiting Toxicity (DLT)|"The number participants experiencing a DLT was used to identify the maximum tolerated dose (MTD) of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level with less than 4 out of 12 participants experiencing a DLT.~A DLT was defined as:~Erosion/ulceration Grade 4 on the Local Skin Response (LSR) scale~Other clinically relevant signs or symptoms observed, which the International Co-ordinating Investigator judges to be counted as a DLT.~The Local Skin Responses consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category are given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity."|From Day 1 up to and including Day 8||||Participants|||Count of Participants
2606361|NCT02100670|Secondary|Patient's Global Assessment in Response to Treatment (PGART)|PGART was measured at the end of study in a scale from 0-4 (Where: 0- Poor; 1- Fair; 2- Good; 3- Very Good; 4- Excellent)|up to Day 10|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||Participants|||Number
2606362|NCT02100670|Secondary|Time to Complete Recovery|Time to complete recovery measured as the day with complete relief of ankle pain (Participant-rated NRS scores were 0 for pain intensity at rest and pain) and swelling (Participants did not have any apparent swelling nor experience any pain or limitation of movement of the injured ankle as determined by the Principal Investigator or designee during the course of an ankle exam).|up to 240 hours|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||Hours||Full Range|Median
2606363|NCT02100670|Secondary|Ankle Swelling|"Ankle swelling measured by figure of eight method of injured ankle."|Day 1 (baseline), 3, and 7|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||Millimeters||Standard Deviation|Mean
2606364|NCT02100670|Secondary|Skin Temperature|Skin temperature was measured by thermal imaging.|At 10, 30, 60 minutes, 4 and 6 hours|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||degree celsius (°C)||Standard Deviation|Mean
2606365|NCT02100670|Secondary|Total Pain Relief (TOTPAR)|TOTPAR was calculated as sum of the products of PRS with time interval from one time point to the other. PRS was measured at each time point on a scale: 0= No pain relief, 1= A little or perceptible pain relief, 2= Meaningful pain relief, 3= A lot of relief, 4= Complete relief. The possible range of TOTPAR for 0-6 hours was from 0 to 24, for 0-12 hours was from 0 to 48, for 0-24 hours was from 0 to 96, for 0-72 hours was from 0 to 288, for 24-72 hours was from 0 to 192 and for 0-168 hours was from 0 to 672.|Baseline to 168 hours|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||PRS Score (0 – 4 scale)||Standard Deviation|Mean
2606366|NCT02100670|Secondary|Time of Onset of Cooling Sensation (TOCS)|"Time of onset of cooling sensation measured by time when subjects reported to have a 'cooling effect as an enhancement of pain relief'. To assess this endpoint, participants were asked at 10, 30 minutes and at 1, 4, 6 hours post first dose Do you feel a cooling sensation at the injured ankle from the study gel?"|up to 6 hours|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||Hours||Full Range|Median
2606367|NCT02100670|Secondary|Time of Onset of Meaningful Pain Relief (TOMR)|"TOMR was measured by time when participants reported PRS ≥ 2, i.e. some or meaningful pain relief"|up to 10 days (end of study)|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||Hours||Full Range|Median
2606368|NCT02100670|Secondary|Time of Onset of Pain Relief (TOPR)|"TOPR was measured by time when participants reported PRS ≥ 1, i.e. a little or perceptible pain relief'."|Baseline to 10 days (end of study)|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||Hours||Full Range|Median
2606369|NCT02100670|Secondary|Sum of Pain Intensity Difference (SPID)|SPID was calculated as the time weighted sum of pain intensity differences (PID) from 0 to 7 Days. PID was calculated as PI at a given time point 't' subtracted by the PI at baseline. PI was measured on NRS scale from 0 (no pain) to 10 (extreme pain). The possible range of SPID for 0-6 hours was from -60 to 60, for 0-12 hours was from -120 to 120, for 0-1 day was from -240 to 240, for 0-3 days was from -720 to 720, for 0-7 days was from -1680 to 1680. A higher value of SPID indicates greater pain relief.|Baseline to Day 7|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||score on a scale||Standard Deviation|Mean
2606370|NCT02100670|Secondary|Pain Relief Score (PRS)|Pain relief was measured at each time point using a 5-point Pain Relief Scale ranging from 0-4 while at rest (Where: 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief). Participants assessed the degree of ankle pain relief using the PRS scores at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after the first day of treatment.|Day 1 to Day 7|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. n is number of participants analyzed for respective time point for this outcome.|||score on a scale||Standard Deviation|Mean
2606371|NCT02100670|Secondary|PID at Rest|"PID at rest was calculated as PI at a given time point't' (at rest) subtracted by the PI at baseline. Participants assessed the severity of ankle pain (PI) using the NRS scale from 0 (no pain) to 10 (extreme pain).~PI was measured at baseline (prior to treatment) and at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing."|Baseline to 10 days|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. n is number of participants analyzed for respective time point for this outcome.|||score on a scale||Standard Deviation|Mean
2606372|NCT02100670|Secondary|Pain Intensity Difference (PID) on Movement|"PID on movement, calculated as PI at a given time 't' (after walking 5 steps on a flat surface) subtracted by the PI at baseline.~Participants assessed the severity of ankle pain (PI) using the NRS scale from 0 (no pain) to 10 (extreme pain). PI was measured at baseline (prior to treatment) and at 10, 30 minutes (min.) and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing."|Baseline to 10 days|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population. n is number of participants analyzed for respective time point for this outcome.|||score on scale||Standard Deviation|Mean
2606373|NCT02100670|Secondary|AUC1-3 Days of PI on Movement for Diclofenac Sodium + Methanol, Diclofenac, Methanol and Placebo|AUC of PI on movement was measured by a numerical rating scale (NRS) during the 48 hour time interval from Day 1 to 3. AUC1-3 day was calculated based on trapezoidal method. Pain intensity was measured in NRS scale from 0 (no pain) to 10 (extreme pain). Participants assessed the severity of ankle pain using the NRS scale at baseline (prior to treatment) and at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing.|up to 72 hours|ITT population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||NRS Score (0 – 10 scale) * hrs||Standard Deviation|Mean
2606374|NCT02100670|Primary|Area Under the Curve From Day 1 to Day 3 (AUC1-3 Days) of Pain Intensity(PI) on Movement for Diclofenac/Methanol Gel and Placebo Gel|AUC of PI on movement was measured by a numerical rating scale (NRS) during the 48 hour time interval from Day 1 to 3. AUC1-3 day was calculated based on trapezoidal method. Pain intensity was measured in NRS scale from 0 (no pain) to 10 (extreme pain). Participants assessed the severity of ankle pain using the NRS scale at baseline (prior to treatment) and at 10, 30 minutes and 1, 4, 6, 12, 18 and 24 hours after the first dose of treatment and twice daily after dosing.|up to 72 hours|Intent-to-Treat (ITT) population included all participants who fulfilled all the study entry criteria, received the study treatment and had at least one post-baseline efficacy assessment. This analysis was conducted on ITT population.|||NRS Score (0 – 10 scale) * hrs||Standard Deviation|Mean
2606386|NCT02100514|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 (Follow up), 71, 84, 97 and 110: Extension Period||Baseline, Week 58 (follow up), 71, 84, 97, 110|All participants who consented for extension period. This outcome measure was planned not to be analyzed for reporting arms: Placebo (Extension Period) and Bococizumab ADA negative (Extension Period).|||percent change||Standard Deviation|Mean
2606387|NCT02100514|Secondary|Number of Participants Who Changed Concomitant Medication During Extension Period|In this outcome measure, total number of participants who changed their lipid-lowering medications or added a monoclonal antibody medication during the extension period were reported.|Week 58 follow-up to Week 110|All participants who consented for extension period.|||Participants|||Count of Participants
2606375|NCT02100644|Secondary|Number of Participants With Adverse Events (AEs), AEs Leading to Discontinuation of the Investigational Product and/or Withdrawal From the Study, Drug-related AEs, Deaths and Serious Adverse Events (SAEs) Throughout the Study|An AE is defined as untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, is a congenital anomaly/birth defect, based on medical or scientific judgement and all events of possible drug-induced liver injury.|From the start of study treatment until follow-up (up to 50 weeks)|Safety Population: comprised of participants who received at least one dose of the investigational product during the LTG Escalation Phase.|||Participants|||Number
2606376|NCT02100644|Secondary|Percentage of Participants Who Completed or Discontinued From the Study|Following cases were considered for participants to have completed a part of or whole of the study. For whole period completion: participants who completed the last LTG and VPA Maintenance Phase visit (M5) in the LTG and VPA Maintenance Phase and follow-up examination. For LTG Escalation Phase completion: participants who reached 200 mg/d of LTG (or 100-200 mg/d of LTG if there were safety concerns) within 8-18 weeks of the phase. For VPA Reduction Phase completion: participants who completed the last fixed dose of VPA Reduction Phase visit (0 mg/d) (FR4) of the phase. For LTG and VPA Maintenance Phase completion: participants who completed M5 of the phase. Participants who met any of the withdrawal criteria after the start of investigational product were considered to have discontinued the study. Percentage of participants who completed or discontinued/withdrawn from the study is presented.|Up to 50 weeks|Enrolled Population: comprised of all participants who had a Baseline (Week 0) visit.|||Percentage of participants|||Number
2606377|NCT02100644|Secondary|Change From Baseline in Quality of Life in Epilepsy for Adolescents (QOLIE-AD-48) in Participants Aged 15-17 Years|QOLIE-AD-48 is a questionnaire analyzed according to the scoring manual at Baseline, at the end of the LTG/VPA Maintenance Phase and withdrawals for participants aged 15-17 years (n=6). Particpants who has started by QOLIE-AD-48 were using the same questionnaire even after 18 years old. Overall score was calculated as an average of sub scores that were normalized to 0 to 100. QOLIE-AD-48 has 8 subscale items (epilepsy impact, memory/concentration, physical fuctioning, stigma, social support, school behavior, attitudes towards epilepsy and health perceptions). Higher score presents higher quality of life. Epileptic symptoms generally affect the QOL of participants, and so QOLIE-AD-48 is world widely used for the QOL assessment of non-adult participants. Baseline is defined as Day 1 (pre-dose) value. Change from Baseline is calculated as post-dose visit value minus Baseline value.|Baseline and up to 46 weeks|FAS Population. Only those participants available at the indicated phase were analyzed (represented by n=X in the category titles).|||Units on a scale||Standard Deviation|Mean
2606378|NCT02100644|Secondary|Change From Baseline in Quality of Life in Epilepsy-31-P (QOLIE-31-P) in Participants Aged 18 Years and Older|QOLIE-31-P is a questionnaire analyzed according to the scoring manual at Baseline, at the end of LTG/VPA Maintenance Phase and withdrawals for the participants aged 18 years and older (n=26, excluding 1 participant withdrawn due to protocol violation). Overall score was calculated as an average of sub scores that were normalized to 0 to 100. QOLIE-31-P has 7 subscale items (energy, mood, daily activities, cognition, medication effect, seizure worry and overall QOL). Higher score presents higher quality of life. Epileptic symptoms generally affect the QOL of participants, and so QOLIE-31-P is world widely used for the QOL assessment of adult participants. Baseline is defined as Day 1 (pre-dose) value. Change from Baseline is calculated as post-dose visit value minus Baseline value.|Baseline and up to 46 weeks|FAS Population. Only those participants available at the indicated phase were analyzed (represented by n=X in the category titles).|||Scores on a scale||Standard Deviation|Mean
2606379|NCT02100644|Secondary|Number of Days in Total That Epileptic Seizures Occurred up to the LTG and VPA Maintenance Phase|The participants with no seizure, had no record in seizure dairy. Only those participants with more than one seizure were assessed for this Outcome Measure.|Baseline and up to 46 weeks|FAS Population|||Days|||Number
2606380|NCT02100644|Primary|Percent Change in the VPA Dose|Percent change in VPA dose is calculated as (pre-dose - post-dose) / pre-dose x 100. Pre-dose is the VPA dose at the Baseline visit and post-dose is the last VPA dose during the LTG and VPA Maintenance Phase.|Baseline and at the end of the LTG and VPA Maintenance Phase, 24-46 weeks that can be varied by durations of the LTG Escalation Phase and VPA Reduction Phase|FAS Population|||Percentage of reduction||Standard Deviation|Mean
2606381|NCT02100644|Primary|Percentage of Participants Who Achieved Reduction in Daily VPA Dose|The VPA dose reduction from Baseline is defined as post VPA dose minus the Baseline VPA dose < 0. Baseline VPA dose is the dose at the Baseline visit (Week 0) and the post VPA dose is the last VPA dose during the LTG and VPA Maintenance Phase. Percentage of participants with dose reduction during the LTG and VPA Maintenance Phase is presented.|Baseline and at the end of the LTG and VPA Maintenance Phase, 24-46 weeks that can be varied by durations of the LTG Escalation Phase and VPA Reduction Phase|Full analysis set (FAS): comprised of all participants in the Safety Population who provided at least one efficacy data after the first dose of the investigational product during the LTG Escalation Phase.|||Percentage of participants||95% Confidence Interval|Number
2606382|NCT02100579|Secondary|Length of Hospitalization|The average time to discharge in hours. Participants were discharged home went physical therapy criteria were met.|0 to 192 hours||||hours||95% Confidence Interval|Mean
2606383|NCT02100579|Secondary|Visual Analog Scale Pain Score|Visual Analog Scale pain score; 0 = no pain, 10 = excruciating pain) in the knee recorded every 6 hours up to 36hrs following surgery.|Pain burden at 36hr||||scores*hours||Inter-Quartile Range|Median
2606384|NCT02100579|Primary|Opioid Consumption (mg morEq)|Opioid consumption (morphine equivalents)|36 hours||||Morphine Equivalents||Inter-Quartile Range|Median
2606385|NCT02100514|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period|Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 log2 unit was considered to be ADA positive and nAb titer >=1.58 log2 unit was considered to be nAb positive.|Week 58 (follow-up), Week 71, Week 84, Week 97, Week 110|"All participants who consented for extension period. This outcome measure was planned not to be analyzed for reporting arms Placebo (Extension period) and Bococizumab ADA negative (Extension period). Here, n signifies number of participants who were evaluable at specified time points."|||percentage of participants|||Number
2606388|NCT02100514|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period|Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 (log 2) unit was considered to be ADA positive and nAb titer >=1.58 (log 2) unit was considered to be nAb positive.|Baseline up to Week 58|"Analysis set included all participants who received at least 1 dose of PF-04950615 150 mg. This outcome measure was planned not to be analysed for placebo reporting arm. Here N signifies number of subjects who were evaluable for this outcome measure."|||Percentage of participants|||Number
2606389|NCT02100514|Secondary|Percentage of Participants With Adverse Events (AEs) Related to Type 1 and 3 Hypersensitivity Reactions and Injection Site Reactions|Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia's, polysynovitis, fever and if severe then included glomerulonephritis. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, inflammation, mass, pain, paraesthesia, pruritus, swelling, vesicles, warmth, scab and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.|Baseline up to end of study (up to 110 weeks)|Safety analysis set included all participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
2606390|NCT02100514|Secondary|Plasma Concentration Versus Time Summary of PF-04950615||Week 12, 24, 52|"Analysis set included participants who received at least 1 dose of PF-04950615. This outcome measure was planned not to be analysed for placebo reporting arm. Here, n signifies those participants who were evaluable at specified time points."|||microgram per milliliter||Standard Deviation|Mean
2606391|NCT02100514|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm respectively.|||percentage of participants|||Number
2606392|NCT02100514|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm respectively.|||percentage of participants|||Number
2606393|NCT02100514|Secondary|Absolute Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants evaluable at specified time points."|||ratio||Standard Deviation|Mean
2606394|NCT02100514|Secondary|Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||ratio||Standard Deviation|Mean
2606395|NCT02100514|Secondary|Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
2606396|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
2606397|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
2606398|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
2606399|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
2606400|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
2606401|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12||Baseline, Week 12|"A subset of FAS included all participants who were randomized and had TG >=200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
2606402|NCT02100514|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12||Baseline, Week 12|"A subset of FAS included all participants who were randomized and had TG <200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
2606403|NCT02100514|Secondary|Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
2606404|NCT02100514|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
2606451|NCT02100124|Primary|Contraceptive Use|Percentage of surveys with any contraceptive use|24 months||||percentage of surveys||Standard Deviation|Mean
2606405|NCT02100514|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
2606406|NCT02100514|Secondary|Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
2606407|NCT02100514|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period||Baseline, Week 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
2606408|NCT02100514|Secondary|Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
2606409|NCT02100514|Secondary|Percent Change From Baseline in Fasting Lipoprotein (A) (Lp[A]) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."|||percent change||Standard Deviation|Mean
2606410|NCT02100514|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"A subset of FAS included all participants who were randomized and had TG >=200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."|||percent change||Standard Deviation|Mean
2606411|NCT02100514|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"A subset of FAS included all participants who were randomized and had TG <200 mg/dL at pre-randomization. Here, n signifies number of participants who were evaluable at the specified time points."|||percent change||Standard Deviation|Mean
2606412|NCT02100514|Secondary|Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."|||percent change||Standard Deviation|Mean
2606413|NCT02100514|Secondary|Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."|||percent change||Standard Deviation|Mean
2606414|NCT02100514|Secondary|Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."|||percent change||Standard Deviation|Mean
2606415|NCT02100514|Primary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, Number of participants analyzed (N) signifies number of participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
2606416|NCT02100475|Secondary|Number of Treatment-emergent Confirmed Hypoglycaemic Episodes|Treatment-emergent hypoglycaemic episodes: if the onset of the episode occurred on or after the first day of investigational medicinal product administration, and no later than 7 days after the last day on investigational medicinal product. Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded plasma glucose < 3.1 mmol/L (56 mg/dL).|Week 0 - 26|Safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or comparator (31 subjects). Confirmed hypoglycaemic episodes were reported by 2 subjects in IDegLira arm and 2 subjects in IDegLira + IAsp arm.|||Number of episodes|||Number
2606417|NCT02100475|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight after 26 weeks of treatment.|Week 0, week 26|FAS included all randomised subject (31 subjects). Missing data were imputed using the LOCF method.|||Kilograms||Standard Deviation|Mean
2606418|NCT02100475|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, week 26|Full analysis set (FAS) included all randomised subjects (31 subjects). Missing data were imputed using the last observation carried forward (LOCF) method.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
2606419|NCT02100410|Secondary|Handling on Removal|Handling on removal (after 30 minutes of wear) was assessed by the participant on a scale from 1 to 10 (1=poor and 10=excellent). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).|Day 1|This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria.|||units on a scale||Standard Deviation|Mean
2606420|NCT02100410|Secondary|Lens Awareness|Lens awareness was assessed by the participant on a 5-point scale (0=none and 4=severe) within the first 5 minutes of wear for each eye separately.|Day 1|This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria.|||units on a scale||Standard Deviation|Mean
2606421|NCT02100410|Primary|Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear|Axis orientation (the rotational positioning of the lens on the eye) was indicated by an axis mark. The actual location of the axis mark was evaluated during slit lamp review and compared to the ideal location for the axis mark, with the difference measured in degrees (0 to +/- 180). The ideal location for the axis mark was iteration-specific (either 6 o'clock or 3 and 9 o'clock). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).|Day 1|This analysis population includes all all randomized participants satisfying all of the inclusion/exclusion criteria.|||percentage of lenses|||Number
2606422|NCT02100319|Secondary|Percentage of Participants Who Had One or More Adverse Events||Up to Week 24|Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.|||Percentage of Participants|||Number
2606903|NCT02096003|Primary|Post Operative Fentanyl PCA Consumption|Total dose of fentanyl patient controlled analgesia (pca) used in 24 hours post-op.|at 24 hours||||µg||Standard Deviation|Mean
2606423|NCT02100319|Secondary|Changes From Baseline in Creatinine-adjusted Urinary Albumin Level on Final Assessment Point (up to Week 24) at the Medical Institution|"Reported data were changes from baseline in creatinine-adjusted urinary albumin level (that is calculated from urinary albumin level divided by creatinine level) measured at the medical institution. Here mg/gCr is Milligrams per Gram of Creatinine."|From baseline up to final assessment point (up to Week 24)|"Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.~The analyzed numbers were participants who were evaluable for this outcome measure."|||mg/gCr||Standard Deviation|Mean
2606424|NCT02100319|Secondary|Changes From Baseline in Hemoglobin A1c (HbA1c) on Final Assessment Point (up to Week 24) at the Medical Institution|Reported data were changes from baseline in HbA1c (National glycohemoglobin standardization program [NGSP] value) measured at the Medical Institution.|From baseline up to final assessment point (up to Week 24)|"Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.~The analyzed numbers were participants who were evaluable for this outcome measure."|||Percent||Standard Deviation|Mean
2606425|NCT02100319|Secondary|Changes From Baseline in Pulse Rate on Final Assessment Point (up to Week 24) at the Medical Institution|Reported data were changes from baseline in pulse rate measured at the medical institution.|From baseline up to final assessment point (up to Week 24)|"Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.~The analyzed numbers were participants who were evaluable for this outcome measure."|||Beat per Minutes (bpm)||Standard Deviation|Mean
2606426|NCT02100319|Primary|Changes From Baseline in Home Blood Pressure on Final Assessment Point (up to Week 24)|Reported data were changes from baseline in blood pressure (SBP and DBP) measured at home right after waking up and at bedtime.|From baseline up to final assessment point (up to Week 24)|"Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.~The analyzed numbers were participants who were evaluable for this outcome measure."|||mmHg||Standard Deviation|Mean
2606427|NCT02100319|Primary|Changes From Baseline in Blood Pressure on Final Assessment Point (up to Week 24) Measured at the Medical Institution|Reported data were changes from baseline in blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) measured at the medical institution.|From baseline up to final assessment point (up to Week 24)|"Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.~The analyzed numbers were participants who were evaluable for this outcome measure."|||Millimeter of Mercury (mmHg)||Standard Deviation|Mean
2606428|NCT02100280|Secondary|CRP|Blood samples are collected from the antecubital vein of the arm not used for IV infusion 48 hr after the end of operation for analysis of CRP.|48 hr after end of operation||||pg / ml||Standard Deviation|Mean
2606429|NCT02100280|Secondary|IL-8|Blood samples are collected from the antecubital vein of the arm not used for IV infusion 1 hr after the end of operation for analysis of IL- 8.|1 hr after end of operation||||pg / ml||Standard Deviation|Mean
2606430|NCT02100280|Secondary|IL-1β|Blood samples are collected from the antecubital vein of the arm not used for IV infusion at the end of peritoneal closure for analysis of IL-1β.|30min before end of operation||||pg / ml||Standard Deviation|Mean
2606431|NCT02100280|Secondary|TNF-α|Blood samples are collected from the antecubital vein of the arm not used for IV infusion at the end of peritoneal closure for analysis of TNF-α.|30min before end of operation||||pg / ml||Standard Deviation|Mean
2606432|NCT02100280|Primary|IL-6|Blood samples are collected from the antecubital vein of the arm not used for IV infusion 1 hr after the end of operation for analysis of IL- 6.|1 hr after the end of operation||||pg / ml||Standard Deviation|Mean
2606433|NCT02100228|Secondary|Number of Participants Who Used Image Guidance Approach|An image-guided approach helped cardioversion earlier than the conventional minimum of 3 weeks of anticoagulation that would normally be required prior to cardioversion. Transesophageal echocardiography (TEE or TOE) and computed tomography (CT) were 2 image-guided approaches that were used in this study.|Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)|Full analysis set included all randomized participants.|||participants|||Number
2606434|NCT02100228|Secondary|Duration of Hospital Stay of Participants|Duration of hospital stay was defined as the number of hours from hospital admission to hospital discharge followed by early cardioversion.|Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)|"Full analysis set included all randomized participants. Here N signifies number of participants who were evaluable for this specified outcome measure."|||hours||Full Range|Median
2606435|NCT02100228|Secondary|Number of Participants With Their Rhythm Status|Rhythm status was further distinguished into sinus rhythm, atrial fibrillation and atrial flutter. Sinus rhythm was defined as a normal heartbeat. Atrial fibrillation was an irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications and atrial flutter was a common abnormal heart rhythm that was usually associated with a fast heart rate (100 or more heart beats per minute).|Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)|"Safety data set included all treated participants (randomized participants who received at least one dose of study drug). Here N signifies number of participants who were evaluable for this specified outcome measure."|||participants|||Number
2606436|NCT02100228|Secondary|Number of Cardioversion Attempt of Participants|Cardioversion attempts were defined as the number of times the participant was admitted to hospital for the cardioversion procedure and not the number of attempts during a single hospital admission.|Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)|Full analysis set included all randomized participants.|||participants|||Number
2606452|NCT02100007|Secondary|Estimate the Overall Survival (OS)|41 subjects were analysed. Overall survival is defined as the first day of study drug administration to death.|Up to 2 years||||months||95% Confidence Interval|Median
2606657|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein|Measured using MSD|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
2606437|NCT02100228|Secondary|Number of Participants With Different Type of Cardioversion Events|Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using different type of cardioversion events i.e. electrical and pharmacologic. Electrical cardioversion was a procedure in which an electric current was used to reset the heart's rhythm back to its regular pattern (normal sinus rhythm). Pharmacologic cardioversion, also called chemical cardioversion, used antiarrhythmia medication instead of an electrical shock.|Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)|"Full analysis set included all randomized participants. Here N signifies number of participants who were evaluable for this specified outcome measure."|||participants|||Number
2606438|NCT02100228|Secondary|Time to First Attempt of Cardioversion|Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using electricity or drugs. First attempt of cardioversion was defined as the first time the participant was admitted for the cardioversion procedure.|Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)|"Full analysis set included all randomized participants. Here, N (number of participants analyzed) signifies participants who were evaluable for this specified outcome measure."|||days||Full Range|Median
2606439|NCT02100228|Primary|Number of Participants With All Cause Death||Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)|Full analysis set included all randomized participants.|||participants|||Number
2606440|NCT02100228|Primary|Number of Participants With Clinically Relevant Non-Major Bleeding Events|Clinically relevant non-major bleeding was defined as the clinically evident bleeding that consisted of any bleeding that compromised hemodynamics, that led to hospitalization, subcutaneous hematoma larger than 25/100 centimeter square if there was a traumatic cause, intramuscular hematoma documented by ultrasonography, epistaxis, gingival bleeding occurred spontaneously, hematuria that was macroscopic and was spontaneous, macroscopic gastrointestinal hemorrhage included at least one episode of melena or hematemesis, rectal blood loss, hemoptysis or any other bleeding type considered to have clinical consequences for a participant, such as medical intervention, the need for unscheduled contact with a physician, or temporary cessation of a study drug, or associated with pain or impairment of activities of daily life.|Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)|Safety data set included all treated participants (randomized participants who received at least one dose of study drug).|||participants|||Number
2606441|NCT02100228|Primary|Number of Participants With Major Bleeding Event|Major bleeding was defined as clinically evident bleeding that was accompanied by one or more of the following: a decrease in hemoglobin of 2 gram per deciliter or more, a transfusion of 2 or more units of packed red blood cells, bleeding that was fatal or bleeding that occurred in at least one of the following critical sites: intracranial, intra-spinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed was not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal.|Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)|Safety data set included all treated participants (randomized participants who received at least one dose of study drug).|||participants|||Number
2606442|NCT02100228|Primary|Number of Participants With Systemic Embolism Event|Systemic embolism occurred in participant when there was a clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which was supported by evidence of embolism from surgical specimens, autopsy, angiography, or other objective testing.|Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)|Full analysis set included all randomized participants.|||participants|||Number
2606443|NCT02100228|Primary|Number of Participants With Acute Stroke Event|An acute stroke was defined as a new, important neurological insufficiency of rapid onset that lasted for at least 24 hours and that was not due to a readily identifiable non-vascular cause (like brain tumor or trauma).|Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)|Full analysis set included all randomized participants.|||participants|||Number
2606444|NCT02100189|Secondary|Tolerability of FISH Spongy Cytology|Tolerability is defined as the patient's willingness to repeat procedure.|After completion of FISH and EGD|Intent to Treat (ITT)|||percentage of subjects tolerating test|||Number
2606445|NCT02100189|Secondary|Adverse Events Associated With FISH Sponge Cytology Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Descriptive statistics will be used to summarize all adverse events associated with FISH sponge cytology test.|At the time of sponge cytology procedure|Intent to Treat (ITT)|||adverse events|||Number
2606446|NCT02100189|Primary|Specificity of Sponge Cytology Using FISH|All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test's sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population.|At the time of sponge cytology and EGD|Per protocol|||Percentage of non-cases among neg tests||95% Confidence Interval|Number
2606447|NCT02100189|Primary|Sensitivity of Sponge Cytology Using FISH|All processed (FISH) esophageal cells will be compared to the final pathologic esophageal diagnoses determined by EGD or surgical resection to assess the test's sensitivity and specificity for the diagnosis of esophageal cancer. Using EGD diagnostic outcomes as the gold standard, the sensitivity and specificity will be computed with corresponding 95% confidence interval of the FISH sponge cytology test in the study population.|At the time of sponge cytology and EGD|Analysis was per protocol|||percentage of cases among positive tests||95% Confidence Interval|Number
2606448|NCT02100124|Secondary|Contraceptive Adherence|Percentage of surveys where contraceptive adherence was high|24 months||||percentage of surveys||Standard Deviation|Mean
2606449|NCT02100124|Secondary|Contraceptive Method Satisfaction|percentage of surveys where very satisfied with contraceptive method|24 months||||percentage of surveys||Standard Deviation|Mean
2606450|NCT02100124|Secondary|Effectiveness of Contraceptive Method|Percentage of surveys where most effective contraceptive method used|24 months||||percentage of surveys||Standard Deviation|Mean
2606453|NCT02100007|Secondary|Estimate Overall Response Rate for ME-344 Given in Combination With Topotecan|Overall response rate was defined as the total number of patients with Complete Response plus Partial Response. All efficacy assessments were to include a baseline assessment and follow-up assessments at a minimum of every 8 weeks for the first 6 cycles, then every 12 weeks thereafter, while receiving study drug. Tumor response and progression-free survival were assessed using RECIST 1.1 criteria or GCIG criteria for CA-125 levels.|Response was assessed throughout the trial up to 13 months|Part 1 (N =12), Part 2 (N=29)|||participants|||Number
2606454|NCT02100007|Secondary|Mean Terminal Half-life (t 1/2)|Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.|Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion|Samples were collected from patients in Part 1 of the study for measurement of plasma concentration of ME-344. Samples were collected from 13 patients in Part 1.|||hours||Standard Deviation|Mean
2606455|NCT02100007|Secondary|Minimum Plasma Concentration (Cmin) of ME-344|Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.|Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion|Samples were collected from patients in Part 1 of the study for measurement of plasma concentration of ME-344. Samples were collected from 13 patients in Part 1.|||ng/mL||Standard Deviation|Mean
2606456|NCT02100007|Secondary|Time to Maximum Plasma Concentration for ME-344 (Tmax)|Various pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data.|Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion|Samples were collected from patients in Part 1 of the study for measurement of plasma concentration of ME-344. Samples were collected from 13 patients in Part 1|||hours||Full Range|Mean
2606457|NCT02100007|Secondary|Maximum Plasma Concentration (Cmax)|Peak Plasma Concentration (Cmax) of ME-344 in combination with topotecan|Cycle 1 Day 1, at 0, .5, 1, 2, 4, 6 and 24 hours post-dose and Day 15 at 0 and end of infusion|Pharmacokinetic parameters for ME-344 in plasma were calculated based on the plasma concentration data from 13 patients who received treatment in Part 1 of the study.|||ng/mL||Standard Deviation|Mean
2606458|NCT02100007|Primary|Number of Serious Adverse Events|The SAE Profile will be determined by the number of SAEs|Through study completion- an average of 2 years|46 subjects received > 2 doses of ME-344 and topotecan and were eligible for DLT analysis.|||SAEs|||Number
2606459|NCT02100007|Primary|Number of Adverse Events|The AE Profile will be determined by the number of AEs regardless of severity|Through study completion- an average of 2 years|46 subjects received > 2 doses of ME-344 and topotecan and were eligible for DLT analysis.|||adverse events|||Number
2606460|NCT02099838|Other Pre-specified|Change of DBil From Baseline at Week 12|Measuring venous level of DBil(direct bilirubin) at the start of the trail and at week 12 in all subjects, then analyzing the change in DBil from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on safety set：all participants who received intervention at least once and had actual data of safety record.|||mmol/L||Standard Deviation|Mean
2606461|NCT02099838|Other Pre-specified|Change of TBil From Baseline at Week 12|Measuring venous level of TBil(total bilirubin) at the start of the trail and at week 12 in all subjects, then analyzing the change in TBil from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on safety set：all participants who received intervention at least once and had actual data of safety record.|||mmol/L||Standard Deviation|Mean
2606462|NCT02099838|Other Pre-specified|Change of AST From Baseline at Week 12|Measuring venous level of AST at the start of the trail and at week 12 in all subjects, then analyzing the change in AST from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on safety set：all participants who received intervention at least once and had actual data of safety record.|||U/L||Standard Deviation|Mean
2606463|NCT02099838|Other Pre-specified|Change of ALT From Baseline at Week 12|Measuring venous level of ALT at the start of the trail and at week 12 in all subjects, then analyzing the change in ALT from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on safety set：all participants who received intervention at least once and had actual data of safety record.|||U/L||Standard Error|Mean
2606464|NCT02099838|Secondary|Change of LDL From Baseline at Week 12|Measuring venous level of LDL(Low-Density Lipoprotein) at the start of the trail and at week 12 in all subjects, then using the natural logarithm of LDL to analyze the change in LDL from baseline at week 12 and compare that between experiment group and control group, since the LDL wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.|||ln(mmol/L)||Standard Deviation|Mean
2606465|NCT02099838|Secondary|Change of HDL From Baseline at Week 12|Measuring venous level of HDL(High-Density Lipoprotein) at the start of the trail and at week 12 in all subjects, then analyzing the change in HDL from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.|||mmol/L||Standard Deviation|Mean
2606466|NCT02099838|Secondary|Change of TG From Baseline at Week 12|Measuring venous level of TG(Triglyceride) at the start of the trail and at week 12 in all subjects, then analyzing the change in TG from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.|||mmol/L||Standard Deviation|Mean
2606467|NCT02099838|Secondary|Change of TC From Baseline at Week 12|Measuring venous level of TC(Total Cholesterol) at the start of the trail and at week 12 in all subjects, then analyzing the change in TC from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.|||mmol/L||Standard Deviation|Mean
2607090|NCT02093897|Secondary|Consumption of rVIII-SingleChain (On-demand Regimen) - Number of Infusions Per Subject Per Year||Up to 1 year|Subjects assigned to the on-demand treatment regimen.|||number of infusions per subject per year||Full Range|Median
2606468|NCT02099838|Secondary|Change of 2-hour Postprandial Insulin From Baseline at Week 12|Measuring venous level of 2-hour postprandial insulin at the start of the trail and at week 12 in all subjects, then using the natural logarithm of 2-hour postprandial insulin to analyze the change in 2-hour postprandial insulin from baseline at week 12 and compare that between experiment group and control group, since the 2-hour postprandial insulin wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.|||ln(mU/L)||Standard Deviation|Mean
2606469|NCT02099838|Secondary|Change of Fasting Insulin From Baseline at Week 12|Measuring venous level of fasting insulin at the start of the trail and at week 12 in all subjects, then using the natural logarithm of fasting insulin to analyze the change in fasting insulin from baseline at week 12 and compare that between experiment group and control group, since the fasting insulin wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.|||ln(mU/L)||Standard Deviation|Mean
2606470|NCT02099838|Secondary|Change of 2hPPG From Baseline at Week 12|Measuring venous level of 2hPPG(2-hour postprandial glucose) at the start of the trail and at week 12 in all subjects, then analyzing the change in 2hPPG from baseline at week 12 and comparing that between experiment group and control group. Change = (Baseline Level - Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.|||mmol/L||Standard Deviation|Mean
2606471|NCT02099838|Secondary|Change of FPG From Baseline at Week 12|Measuring venous level of FPG(fasting plasma glucose) at the start of the trail and at week 12 in all subjects, then using the natural logarithm of FPG to analyze the change in FPG from baseline at week 12 and compare that between experiment group and control group, since the FPG wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded.|||ln(mmol/L)||Standard Deviation|Mean
2606472|NCT02099838|Primary|Change of HbA1c From Baseline at Week 12|Measuring venous level of HbA1c at the start of the trail and at week 12 in all subjects, then using the natural logarithm of HbA1c to analyze the change in HbA1c from baseline at week 12 and compare that between experiment group and control group, since the HbA1c wasn't normal distribution and was logarithmic normal distribution. Change = ln(Baseline Level) - ln(Week 12 Level).|Baseline, Week 12|Based on the full analysis set: all participants who were eligible or drop-out, but eliminated participants were excluded. Intention to treat analysis and last observational carried forward(LOCF) imputation method.|||ln(percent)||Standard Deviation|Mean
2606473|NCT02099786|Primary|Hearing-related Quality of Life Measure|"Differences in the Hearing Handicap Inventory for Adults (HHIA) questionnaire score [or Hearing Handicap Inventory for the Elderly (HHIE) score as appropriate] depending on the age of the subject.~Minimum possible value = 0 Maximum possible value = 100 A higher score indicates poorer performance"|1 year post randomization|Missing data on some participants due to loss of follow up.|||score on a scale||Standard Deviation|Mean
2606474|NCT02099786|Primary|Number of Participants With Mortality|Mortality among participants defined as differences in rates of death within one year of randomization.|1 year post randomization||||Participants|||Count of Participants
2606475|NCT02099786|Primary|Number of Participants Who Accessed the Audiology Clinic for Aural Rehabilitation|Veterans randomized to Comp-VA will access and use audiology rehabilitation at higher rates than usual care up to 1 year post-treatment. This includes: New hearing aid issued; Hearing aid adjustments made; Technology updated.|through study completion, an average of 1 year post randomization|All participants who received at least one dose of cisplatin and had at least two Program Evaluations.|||Participants|||Count of Participants
2606476|NCT02099786|Primary|Number of Participants With an Ototoxic Hearing Shift|"Veterans randomized to the COMP-VA arm will have improved hearing outcomes (a) fewer ASHA-significant threshold shifts, (b) fewer CTCAE grade 1 or greater hearing shifts at Program Evaluation 3 as compared with Veterans randomized to the Usual Care arm.~ASHA Shift is defined as:~20 dB shift at a single frequency 10 dB shift at two adjacent frequencies loss of response at three adjacent frequencies~CTCAE Grade 1 or greater ototoxicity = hearing shift of 15-25 dB averaged at 2 contiguous test frequencies"|35 days post randomization||||Participants|||Count of Participants
2606477|NCT02099708|Secondary|Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions|Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.|||participants|||Number
2606478|NCT02099708|Secondary|Details of Treatment for Gastric or Duodenal Ulcers or Hemorrhagic Lesions|"Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions.~Participants could be counted in more than 1 treatment category."|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.|||participants|||Number
2606479|NCT02099708|Secondary|Treatment for Gastric/Duodenal Ulcer or Lesion|Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.|||participants|||Number
2606480|NCT02099708|Secondary|Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion|Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.|||participants|||Number
2607091|NCT02093897|Secondary|Consumption of rVIII-SingleChain (On-demand Regimen) - Number of Infusions Per Subject Per Month||Up to 1 year|Subjects assigned to the on-demand treatment regimen.|||number of infusion per subject per month||Full Range|Median
2606481|NCT02099708|Secondary|Presence of Onset of Gastric or Duodenal Hemorrhagic Lesion|Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesion.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.|||participants|||Number
2606482|NCT02099708|Secondary|Presence of Gastric or Duodenal Ulcer|Summary of data on the presence or absence of gastric or duodenal ulcer.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.|||Participants|||Number
2606483|NCT02099708|Secondary|Presence or Absence of Endoscopic Examinations|Summary of data on the presence or absence of gastric or duodenal ulcers by using endoscopic examinations.|From baseline to 12 months|Efficacy Analysis Set: all participants from the SAS, excluding those for whom usage of NSAIDs during the treatment of lansoprazole was not confirmed and those who had gastric or duodenal ulcers at the start of administration of lansoprazole.|||participants|||Number
2606484|NCT02099708|Primary|Frequency of Adverse Drug Reactions|Frequency was defined as the number of participants for each adverse event Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|Safety analysis set (SAS) - All participants who received at least 1 dose of open-label study drug.|||participants|||Number
2606485|NCT02099682|Secondary|Treatment Outcome (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions|Summary of data on the outcome of treatment for gastric or duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.|||participants|||Number
2606486|NCT02099682|Secondary|Details of Treatment (Including Duplicates) for Gastric or Duodenal Ulcers or Hemorrhagic Lesions|Summary of data on the details of treatment for gastric or duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.|||participants|||Number
2606487|NCT02099682|Secondary|Treatment for Gastric/Duodenal Ulcer or Lesion|Summary of data on the presence or absence of treatment for duodenal ulcers or hemorrhagic lesions.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.|||participants|||Number
2606488|NCT02099682|Secondary|Presence of Either Gastric/Duodenal Ulcer, or Gastric/Duodenal Hemorrhagic Lesion|Summary of data on the presence or absence of gastric/duodenal ulcer gastric/duodenal hemorrhagic lesion.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.|||participants|||Number
2606489|NCT02099682|Secondary|Presence of Gastric or Duodenal Hemorrhagic Lesion|Summary of data on the presence or absence of gastric or duodenal hemorrhagic lesions.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.|||participants|||Number
2606490|NCT02099682|Secondary|Presence of Gastric or Duodenal Ulcer|Summary of data on the presence or absence of gastric or duodenal ulcers.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.|||participants|||Number
2606491|NCT02099682|Secondary|Presence or Absence of Endoscopic Examinations|Summary of data on the presence or absence of endoscopic examinations.|From baseline to 12 months|Efficacy analysis set: all participants who took the study drug at least once excluding those with gastric ulcers or duodenal ulcers at initiation of study drug treatment, or participants for whom low-dose aspirin use during study drug treatment could not be confirmed.|||participants|||Number
2606492|NCT02099682|Primary|Frequency of Adverse Drug Reactions|Frequency, severity, and time to onset of adverse drug reactions tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|Safety analysis set - All participants who received at least 1 dose of lansoprazole.|||participants|||Number
2606493|NCT02099461|Primary|Log Ratio of Post-baseline to Baseline Ki-67 Index in Mammary Epithelial Cells|Ki-67 is a marker for cell proliferation. Participants underwent percutaneous core needle breast biopsies on Day 1 (Baseline, prior to treatment) and Day 28. Levels of Ki67 were measured using immunohistochemical staining and digital imaging. The proliferation index was calculated as the percentage of Ki-67 positive terminal ductal lobular unit (TDLU) and duct epithelial cells. The higher the percentage, the higher the rate of epithelial cell proliferation.|Baseline and Day 28|Pharmacodynamic analysis set with non-missing data|||log ratio||Standard Deviation|Mean
2606494|NCT02099344|Secondary|Examine Incidence of Complications in Patients Receiving the Artegraft Bovine Graft vs. Gore Propaten Graft|Complication incidence will be collected from the time of access creation until the graft fails and is abandoned.|12 months|Data not collected due to early study termination||||||
2606658|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein|Measured using MSD|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
2606495|NCT02099344|Primary|Primary Objective: The Primary Objective is to Assess the Primary, Primary Assisted and Secondary Patency Rate of Each Graft|The primary outcome will be determined by Kaplan-Meier life table analysis. Patency determination will be from access creation until the first occlusion of the graft.|12 months|Data not collected due to early study termination||||||
2606496|NCT02099318|Other Pre-specified|Wasted Number of Aneurysm Clips|Number of of aneurysm clips wasted according to OR records.|At time of surgery-Time (minutes/seconds) from first aneurysm clip attempt to final clip placement|Data was lost; no results can be reported||||||
2606497|NCT02099318|Other Pre-specified|Microsurgical Time|"Number of minutes of total microsurgical time:~Defined as the time elapsed from the time the aneurysm was first observed in the OR microscope until the time that the final clip was applied"|At time of surgery-Total time (minutes/seconds) from aneurysm first seen in video to final clip placement|Data was lost; no results can be reported||||||
2606498|NCT02099318|Other Pre-specified|Temporary Clip Time|"Total Number of minutes of temporary clip occlusion:~Defined as the time the temporary clip is released from the clip applier until the temporary clip is removed. (For several temporary occlusions, a cumulative total of all temporary occlusions and total time of overall temporary occlusion time as observed in the operating microscope's video.)"|At time of surgery-Total time (minutes/seconds) of all temporary clip applications to all temporary clip removal|Data was lost; no results can be reported||||||
2606499|NCT02099318|Secondary|Number of Trial Aneurysm Clips Used But Not Implanted|"Number of Clips evaluated:~Defined as clips that were brought in proximity to the aneurysm for evaluation (i.e., were visible in the microscopic field) but were not applied, as observed in the operating microscope's video."|At time of surgery-Time (minutes/seconds) from first clip to contact aneurysm to final clip placement|Data was lost; no results can be reported||||||
2606500|NCT02099318|Primary|Aneurysm Clip Time|"Number of Clipping attempts:~Applying a clip (i.e., closing a clip on the aneurysm)~Removing a clip (i.e., a clip was applied on the aneurysm and then removed)~Adjusting a clip (i.e., the clip was applied on the aneurysm and then opened, adjusted, and closed again)."|At time of surgery-Time (minutes/seconds) from first clip attempt to final clip position(up to 5 minutes)|Data was lost; no results can be reported||||||
2606501|NCT02099266|Secondary|Proportion of Reduced Intensity Conditioning Participants With Complete Engraftment.|Complete engraftment is defined as as marrow reconstitution of greater than 90% of donor cells. Degree of engraftment will be determined through bone marrow chimerism assessment at either day 21 or day 28.|28 days||||Participants|||Count of Participants
2606502|NCT02099266|Secondary|Determine the Effects of HBO Therapy on Neutrophil Count Recovery.|Time in days until neutrophil count recovery is achieved; neutrophil count recovery is defined as three consecutive days of achieving a neutrophil level >/= 500 u/L.|Daily measurement of neutrophil counts up to 90 days post transplant.||||Days||Full Range|Median
2606503|NCT02099266|Primary|Safety of HBO Administration in the Setting of UCB Stem Cell Transplantation|Treatment limiting toxicities are defined as the occurrence of any of the following complications within 24hrs of treatment: pneumothorax, death, irreversible grade III or any grade IV toxicity that is determined by the treating physician to be related to HBO therapy.|Toxicity assessment with 24hrs of treatment|One patient treatment was shortened by approximately 10 minutes because of nausea attributed to concomitant medications.|||Participants|||Count of Participants
2606504|NCT02099110|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 26: Excluding Rescue Approach|This change from baseline reflects the Week 26 systolic blood pressure minus the Week 0 systolic blood pressure. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the systolic blood pressure change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.|||mm Hg||95% Confidence Interval|Least Squares Mean
2606505|NCT02099110|Secondary|Change From Baseline in Static Beta-Cell Sensitivity to Glucose Index at Week 26; Excluding Rescue Approach|Static beta-cell sensitivity to glucose index (SBCSGI) estimates the ratio of insulin secretion (expressed in pmol/min) related to above-basal glucose concentration (expressed in mmol/L * L) following a meal. Blood samples were collected before and after a standard meal and glucose, insulin, and C-peptide levels were analyzed. The C-peptides minimal model was used to estimate the insulin secretion rate (ISR). Analysis included both non-model-based [including insulinogenic index with C-peptide, glucose area under the curve (AUC)/insulin AUC] and model-based [beta cell function and insulin secretion rate at 9 mM glucose] testing. Analysis was performed with non-linear least squares using the Software Architecture Analysis Method (SAAM) II software. SBCSGI was expressed in units of 10^-9 min^-1. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|30 min. before and 0, 15, 30, 60, 90, 120, and 180 minutes following the start of the standard meal at Baseline and Week 26|The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the beta-cell responsivity static component change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.|||SBCSGI (10^-9min^-1)||95% Confidence Interval|Least Squares Mean
2606506|NCT02099110|Secondary|Percentage of Participants Achieving a Hemoglobin A1C of <7% (<53 mmol/Mol) (Raw Proportions): Excluding Rescue Approach|A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Week 26|The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a post-randomization measurement for the A1C change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.|||Percentage of participants|||Number
2606539|NCT02098733|Secondary|Change From Baseline in Fasting Blood Glucose Level|Tabulated the changes from baseline in fasting blood glucose level at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.|||mg/dL||Standard Deviation|Mean
2606507|NCT02099110|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Excluding Rescue Approach|Blood glucose was measured on a fasting basis after at least a 10-hour fast. This change from baseline reflects the Week 26 FPG minus the Week 0 FPG. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the FPG change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
2606508|NCT02099110|Secondary|Change From Baseline in Body Weight at Week 26: Excluding Rescue Approach|This change from baseline reflects the Week 26 body weight minus the Week 0 body weight. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the body weight change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.|||Kilograms||95% Confidence Interval|Least Squares Mean
2606509|NCT02099110|Primary|Percentage of Participants Who Discontinued Study Treatment Due to an AE: Including Rescue Approach|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Including rescue approach data analysis included data following the initiation of rescue therapy.|Up to 52 weeks|The analysis population consists of all randomized participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
2606510|NCT02099110|Primary|Percentage of Participants Who Experienced an Adverse Event (AE): Including Rescue Approach|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Including rescue approach data analysis included data following the initiation of rescue therapy.|Up to 54 weeks|The analysis population consists of all randomized participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
2606511|NCT02099110|Primary|Change From Baseline in A1C at Week 26: Excluding Rescue Approach|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population consisted of all randomized participants who received at least one dose of study treatment, had a baseline measurement or a post-randomization measurement for the A1C change from baseline at Week 26 analysis endpoint subsequent to at least one dose of study treatment.|||Percentage||95% Confidence Interval|Least Squares Mean
2606512|NCT02099084|Other Pre-specified|Urine Volume at 8 Hours|After an overnight fast, subjects received a single dose of placebo or Teduglutide 1 hour before breakfast, then consumed a radiolabeled meal. Urine was collected twice: from the start of the ingestion of the meal to 2 hours, and 2-8 hours. The total volume of urine collected was the sum of these two collections.|Start of the ingestion of the radiolabeled meal until 8 hours after the meal||||mL||Standard Deviation|Mean
2606513|NCT02099084|Other Pre-specified|Stool Weight at 8 Hours|After an overnight fast, subjects received a single dose of placebo or Teduglutide 1 hour before breakfast, then consumed a radiolabeled meal. After 8 hours a stool collection was taken.|approximately 8 hours after ingestion of radiolabeled meal||||g||Standard Deviation|Mean
2606514|NCT02099084|Secondary|Change in Small Intestinal and Colonic Permeability as Measured by Lactulose/Mannitol Ratio at 2 Hours|Permeability is measured through differential excretion of urine saccharides. A sugar solution (200 mg of mannitol and 1 g lactulose in 30 mL of water) was administered with the radiolabeled test meal at visits 1 and 2. Urine was collected during 0-2 and 2-8 hours. A baseline urine sample was also collected prior to ingestion of the sugars. Chemical analysis was preformed with high-speed liquid chromatography tandem mass spectrometry.|baseline, approximately 2 hours after ingestion of radiolabeled meal||||ratio||Standard Deviation|Mean
2606515|NCT02099084|Secondary|Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Lactulose at 2 Hours|Permeability is measured through differential excretion of urine saccharides. A sugar solution (200 mg of mannitol and 1 g lactulose in 30 mL of water) was administered with the radiolabeled test meal at visits 1 and 2. Urine was collected during 0-2 and 2-8 hours. A baseline urine sample was also collected prior to ingestion of the sugars. Chemical analysis was preformed with high-speed liquid chromatography tandem mass spectrometry.|baseline, approximately 2 hours after ingestion of radiolabeled meal||||mg||Standard Deviation|Mean
2606516|NCT02099084|Primary|Overall Gut Transit|Given the variable extent of the residual length of the small intestine and colon, the proportion emptied from the body at 6 hours was assessed as an overall estimate of the whole gut transit. The 6-hour values for intra-abdominal counts were then compared with the 100% reference values of counts (at time zero, which is immediately after ingestion of the radiolabeled meal) to determine the percentage of isotope retained in the abdomen. 100% minus the percentage of retained isotope reflected the amount emptied from the GI tract.|baseline, approximately 6 hours after ingestion of radiolabeled meal||||Percentage of isotope emptied||Standard Deviation|Mean
2606517|NCT02099084|Secondary|Change in Small Intestinal and Colonic Permeability as Measured by Urinary Excretion of Mannitol|Permeability is measured through differential excretion of urine saccharides. A sugar solution (200 mg of mannitol and 1 g lactulose in 30 mL of water) was administered with the radiolabeled test meal at visits 1 and 2. Urine was collected during 0-2 and 2-8 hours. A baseline urine sample was also collected prior to ingestion of the sugars. Chemical analysis was preformed with high-speed liquid chromatography tandem mass spectrometry.|baseline, approximately 2 hours and 8 hours after ingestion of radiolabeled meal||||mg||Standard Error|Mean
2606518|NCT02099084|Primary|Gastric Emptying Half-Time (T1/2)|The time for half of the ingested solids or liquids to leave the stomach.|approximately 2 hours after radiolabeled meal is ingested||||minutes||Standard Deviation|Mean
2606519|NCT02099006|Secondary|Reduction in Tampon Test Pain|"Reduction in the pain, as measured on a 10 point Likert scale, associated with the insertion and removal of a tampon. This is a validated surrogate for pain associated with intercourse. Subjects were asked to insert and remove a tampon each week and report the degree of pain associated with this. A score of 0 was defined as no pain, and a score of 10 was defined as worst imaginable pain."|13 weeks|For each placebo entry the data is limited to include only those participates who also received the named intervention.|||units on a scale||Standard Deviation|Mean
2606520|NCT02099006|Primary|Reduction in Daily Genital Pain.|"Each subject was asked to keep a symptom diary recording her daily genital pain, measured on a 10 point Likert scale. A score of 0 was defined as no pain and a score of 10 was defined as worst imaginable pain. These daily values were collected and a mean pain score for the period of treatment was calculated."|13 weeks|For each placebo entry the data is limited to include only those participates who also received the named intervention.|||units on a scale||Standard Deviation|Mean
2606521|NCT02098993|Secondary|Percentage of Participants Experiencing Multiorgan Dysfunction Syndrome|Acute development of 2 or more organs or organ systems unable to maintain homeostasis in a critically ill individual|7 days||||percent of participants|||Number
2606522|NCT02098993|Secondary|Percentage of Participants Requiring Mechanical Ventilation||7 days||||percent of participants|||Number
2606523|NCT02098993|Secondary|Percentage of Participants Transferred to Intensive Care Unit||7 days||||percent of participants|||Number
2606524|NCT02098993|Secondary|Units of Red Blood Cells Administered|Total number of units of red blood cells|7 days||||units|||Number
2606525|NCT02098993|Secondary|Opioid Administration Per Participant|Total dose of opioids per participant|7 days||||mg||Standard Deviation|Mean
2606526|NCT02098993|Secondary|Duration of Moderate to Severe Pain Assessed by Visual Analog Scale for Pain|Score of 4 or greater on the Visual Analog Scale for pain|7 days||||hours||Standard Deviation|Mean
2606527|NCT02098993|Secondary|Duration of Leukocytosis Assessed by White Blood Cell Count|White blood cell count greater than 10,000 per liter|7 days||||hours||Standard Deviation|Mean
2606528|NCT02098993|Secondary|Duration of Fever Assessed by Body Temperature|Body temperature greater than or equal to 38.0 degrees Celsius|7 days||||hours||Standard Deviation|Mean
2606529|NCT02098993|Secondary|Duration of Hypoxemia Assessed by Arterial Oxygen Saturation|Arterial oxygen saturation less than 90%|7 days||||hours||Standard Deviation|Mean
2606530|NCT02098993|Primary|Time to Hospital Discharge|Duration of hospitalization|Until hospital discharge||||hours||Standard Deviation|Mean
2606531|NCT02098746|Primary|Frequency of Serious Adverse Drug Reactions|Frequency of serious adverse drug reactions is defined at the number of participants with serious adverse drug reactions. Frequency of serious adverse drug reactions were tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|The Safety Analysis Set (safety assessment population) included all patients who received at least one dose of pioglitazone/glimepiride (N=289).|||participants|||Number
2606532|NCT02098746|Secondary|Change From Baseline in Fasting Insulin Level|Tabulation of fasting insulin level and the changes from Baseline at each test time point (test value at each test time point after Baseline - test value at Baseline). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening.|Baseline, Months 3, 6, 9, 12 and at Final assessment|The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point.|||μU/dL||Standard Deviation|Mean
2606533|NCT02098746|Secondary|Change From Baseline in Fasting Blood Glucose Level|Tabulation of fasting blood glucose level and the changes from Baseline at each test time point (test value at each test time point after Baseline - test value at Baseline). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12 and at Final assessment|The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point.|||mg/dL||Standard Deviation|Mean
2606534|NCT02098746|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Tabulation of HbA1c values and the changes from Baseline at each test time point (test value at each test time point after Baseline - test value at Baseline). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12 and at Final assessment|The analysis was performed on the efficacy assessment population (N=250) with data available at the given time-point.|||percent||Standard Deviation|Mean
2606535|NCT02098746|Primary|Frequency of Adverse Drug Reactions|Frequency of adverse drug reactions is defined as the number of participants with adverse drug reactions. Frequency, seriousness, and time to onset of adverse drug reactions were tabulated by each symptom. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|The Safety Analysis Set (safety assessment population) included all patients who received at least one dose of pioglitazone/glimepiride (N=289).|||participants|||Number
2606536|NCT02098733|Secondary|Fasting Insulin Level|Tabulated fasting insulin level at each test time point.|Baseline, Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.|||μU/dL||Standard Deviation|Mean
2606537|NCT02098733|Secondary|Change From Baseline in Fasting Insulin Level|Tabulated the changes from baseline at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.|Baseline, Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.|||μU/dL||Standard Deviation|Mean
2606538|NCT02098733|Secondary|Fasting Blood Glucose Level|Tabulated fasting blood glucose level from baseline at each test time point.|Baseline, Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.|||mg/dL||Standard Deviation|Mean
2606540|NCT02098733|Secondary|Glycosylated Hemoglobin (HbA1c)|Tabulated glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each test time point or final visit relative to baseline.|Baseline, and Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2606541|NCT02098733|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Tabulated the changes from baseline in glycosylated hemoglobin (HbA1c) values at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement.|Baseline, and Months 3, 6, 9, 12 and at Final Assessment|All enrolled participants with data available.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2606542|NCT02098733|Primary|Number of Participants With Adverse Drug Reactions|Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|For 12 months|All enrolled participants with available data.|||participants|||Number
2606543|NCT02098395|Secondary|Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes|Number of treatment-emergent symptomatic hypoglycaemic episodes during 26 weeks of treatment. Symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or a self-measured plasma glucose (SMPG) value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification is defined as an episode that required assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions.|Weeks 0-26|Safety analysis set (SAS) included all subjects exposed to at least one dose of randomised liraglutide or placebo (SAS = 832 subjects). Symptomatic hypoglycaemic episodes were reported by 166 subjects in liraglutide 0.6 mg arm, 175 subjects in liraglutide 1.2 mg, 160 subjects in liraglutide 1.8 mg arm and 162 subjects in liraglutide placebo arm.|||episodes|||Number
2606544|NCT02098395|Secondary|Change From Baseline in Body Weight|Change from baseline body weight, after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.|Week 0, Week 26|Of the 831 subjects in FAS, 27 subjects in lira 0.6 mg arm, 38 subjects in lira 1.2 mg arm, 35 subjects in lira 1.8 mg arm and 26 in placebo arm did not contribute to the analysis. Missing data imputed from a mixed model for repeated measurements (MMRM) method.|||kg||Standard Deviation|Mean
2606545|NCT02098395|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c)|Change from baseline in glycosylated haemoglobin (HbA1c), after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data.|Week 0, Week 26|Out of the 831 subjects in FAS, 22 subjects in lira 0.6 mg arm, 33 subjects in lira 1.2 mg arm, 35 subjects in lira 1.8 mg arm and 16 in placebo arm did not contribute to this analysis. Missing data imputed from a mixed model for repeated measurements (MMRM) method.|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
2606546|NCT02098369|Secondary|PROMIS - Ability to Participate in Social Roles and Activities|Change in T-score from baseline to day 60. (A negative change in score indicates less ability to participate in social roles and activities.)|60 days|The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures.|||T-score||Standard Error|Mean
2606547|NCT02098369|Secondary|PROMIS - Satisfaction With Social Roles and Activities|Change in T-score from baseline to day 60. (A negative change in score indicates less satisfaction with social roles and activities.)|60 days|The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures.|||T-score||Standard Error|Mean
2606548|NCT02098369|Secondary|PROMIS - Emotional Distress - Depression|Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - depression.)|60 days|The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures.|||T-score||Standard Error|Mean
2606549|NCT02098369|Secondary|PROMIS - Sleep Disturbance|Change in T-score from baseline to day 60. (A negative change in score indicates less sleep disturbance.)|60 days|The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures.|||T-score||Standard Error|Mean
2606550|NCT02098369|Secondary|PROMIS - Emotional Distress - Anxiety|Change in T-score from baseline to day 60. (A negative change in score indicates less emotional distress - anxiety.)|60 days|The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures.|||T-score||Standard Error|Mean
2606551|NCT02098369|Secondary|PROMIS - Fatigue|Change in T-score from baseline to day 60. (A negative change in score indicates less fatigue.)|60 days|The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures.|||T-score||Standard Error|Mean
2606552|NCT02098369|Secondary|PROMIS - Physical Function|Change in T-score from baseline to day 60. (A negative change in score indicates worse physical functioning.)|60 days|The number of participants included in the analysis for each outcome measure may not match the total number of participants enrolled in the study as some participants declined to provide responses to some outcome measures.|||T-score||Standard Error|Mean
2606553|NCT02098369|Primary|Adherence to Supplemental O2 Prescription|Number of individuals who used the stationary concentrator for a mean of at least 17.7 hours per day|60 days|All participants with evaluable data for oxygen use across all equipment.|||Participants|||Count of Participants
2606554|NCT02098304|Secondary|User Experience|Completion of User Questionnaires after imaging with the Calcivis System|0 day|User Questionnaires comprised nine questions and users were asked to tick the most appropriate response i.e. extremely easy, easy etc. No numerical values were assigned to the responses.|||User questionnaires|||Number
2606555|NCT02098304|Secondary|Patient Experience|Completion of Patient Questionnaires after imaging with the Calcivis System|Day 0|Patient Questionnaires comprised five questions and the patient was asked to tick the most appropriate response i.e very good, good etc. No numerical values were assigned to the responses|||Patient Questionnaires|Participants||Number
2606556|NCT02098304|Primary|Measure Safety of the Calcivis Caries Imaging System|Collection of all adverse events recorded and reported throughout the duration of the study|Day 0 and Day 7|Adverse events|||adverse events|||Number
2606557|NCT02098304|Primary|Percentage Agreement of Sound/Unsound Teeth Between ICDAS Score and Calcivis System|% agreement calculated as no. of teeth where ICDAS assessment & Calcivis System assessment is in agreement/total number of teeth assessed multiplied by 100. Agreement defined as a sound tooth without luminescence & an unsound tooth with luminescence.|Day 0|All 42 patients recruited are included in the Safety Population, which included any subjects on whom the Calcivis System was used. 31 patients are included in the Agreement Population which included all subjects with at least one tooth with an eligible image. From the 31 patients, 65 teeth were analysed; in some patients multiple teeth were imaged.|||percentage agreement|Participants|95% Confidence Interval|Number
2606558|NCT02098109|Secondary|Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms||Day 5||||percentage of participants|||Number
2606559|NCT02098109|Secondary|Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg in One Apheresis Procedure Following PBSC Mobilization Between the Two Arms||Day 5||||percentage of participants|||Number
2606560|NCT02098109|Secondary|Comparison of the Percentage of Patients Who Collect > 5.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms||Up to Day 8 (total collection)||||percentage of participants|||Number
2606561|NCT02098109|Secondary|Comparison of the Percentage of Patients Who Collect > 2.0x10^6 CD34+Cells/kg Following PBSC Mobilization Between the Two Arms||Up to Day 8 (total collection)||||percentage of participants|||Number
2606562|NCT02098109|Secondary|Comparison of the Readmission Rate Between the Two Arms|Readmission rate is defined as the frequency at which patients are readmitted (after initial post-transplant discharge) following post-infusion of mobilized PBSC product for reasons other than progressive disease/relapse|Up to Day 100|(2) participants in the XM02 Filgrastim (Granix) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure. (1) participant in the Filgrastim (Neupogen) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure.|||Participants|||Count of Participants
2606563|NCT02098109|Secondary|Comparison of the Time to Platelet Engraftment Between the Two Arms|Time to platelet engraftment is measured by determining the first of 3 consecutive measurements of platelet count ≥ 50,000/µl without platelet transfusion support for 7 days. Patients who do not have platelet engraftment by Day 100 post-infusion of mobilized PBSC product will be considered a platelet engraftment failure.|Up to Day 100|(2) participants in the XM02 Filgrastim (Granix) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure. (1) participant in the Filgrastim (Neupogen) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure.|||days||95% Confidence Interval|Median
2606564|NCT02098109|Secondary|Comparison of the Time to Neutrophil Engraftment Between the Two Arms|Time to neutrophil engraftment is measured by determining the first of 3 consecutive measurements of neutrophil count ≥ 500/µl following conditioning regimen-induced nadir. Patients who do not have neutrophil engraftment by Day 30 post-infusion of mobilized PBSC product will be considered a neutrophil engraftment failure.|Up to Day 30 post-infusion|(2) participants in the XM02 Filgrastim (Granix) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure. (1) participant in the Filgrastim (Neupogen) & Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure.|||days||95% Confidence Interval|Median
2606565|NCT02098109|Secondary|Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms|-Adverse events will be assessed using CTCAE version 4.0|Up to 20 days after last apheresis (Day 25-Day 28)||||participants|||Number
2606566|NCT02098109|Primary|Comparison of the Mean Day 5 CD34+Cells/kg Yield Between the Two Arms||Day 5||||cells/kg||Standard Deviation|Mean
2606567|NCT02097992|Primary|Airway Blood Flow Reactivity (Delta Qaw)|percentage of change on airway blood flow induced by albuterol.|Immediate or 4 weeks||||% of change||Standard Error|Mean
2606568|NCT02097849|Secondary|Number of Participants With Abnormalities in Vital Signs|Temperature increase: > 38 celcius (C) or ≥ 1 C increase from baseline. Pulse increase: > 120 beats per minute (bpm) or > 20 bpm increase from baseline. Pulse decrease: < 50 bpm or > 20 bpm decrease from baseline. Systolic blood pressure (SBP) increase: > 180 millimeters of mercury (mmHg) or > 40 mmHg from baseline. SBP decrease: < 90 mmHg or > 30 mmHg decrease from baseline. Diastolic blood pressure (DBP) increase: > 105 mmHg or > 30 mmHg increase from baseline. DBP decrease: < 50 mmHg or > 20 mmHg decrease from baseline.|Screening to Week 4|Participants who had a baseline assessment and at least one postbaseline assessment.|||participants|||Number
2606569|NCT02097849|Secondary|Number of Participants With Shifts From Baseline in Blood Chemistry|Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high.|Screening to Week 4|n=participants whose baseline value was not low (or high) and who had at least one postbaseline value.|||participants|||Number
2606570|NCT02097849|Secondary|Number of Participants With Shifts From Baseline in Hematology|Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high.|Screening to Week 4|n=participants whose baseline value was not low (or high) and who had at least one postbaseline value.|||participants|||Number
2606571|NCT02097849|Secondary|Number of Participants Experiencing Vaccination-Emergent Adverse Events (AEs) and Serious AEs|An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. A serious AE was any untoward medical occurrence that at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could have jeopardized the participant or required intervention to prevent one of the other outcomes listed in the definition above.|Day 1 to Week 4|Participants who received at least one vaccination.|||participants|||Number
2606572|NCT02097849|Secondary|Ratio of Serum Meningococcal Antibodies (Serogroup C) Level at Day 28 to Prevaccination|Median serum titer ratios from prevaccination to 4 weeks after MCV4 vaccination.|Up to Week 4 (Day 28) postvaccination|One participant in the IFN group did not have an assessment.|||ratio||Inter-Quartile Range|Median
2606573|NCT02097849|Secondary|Ratio of Serum Pneumococcal Antibodies (Serotype 8) Level at Day 28 to Prevaccination|Median serum titer ratios from prevaccination to 4 weeks after PPSV23 vaccination.|Up to Week 4 (Day 28) postvaccination||||ratio||Inter-Quartile Range|Median
2606574|NCT02097849|Secondary|Ratio of Serum Pneumococcal Antibodies (Serotype 3) Level at Day 28 to Prevaccination|Median serum titer ratios from prevaccination to 4 weeks after PPSV23 vaccination.|Up to Week 4 (Day 28) postvaccination||||ratio||Inter-Quartile Range|Median
2606575|NCT02097849|Secondary|Ratio of Serum Tetanus Level at Day 28 to Prevaccination|Median serum titer ratios from prevaccination to 4 weeks after Td vaccination.|Up to Week 4 (Day 28) postvaccination||||ratio||Inter-Quartile Range|Median
2606576|NCT02097849|Secondary|Percentage of Meningococcal Serogroup C Responders (≥ 4-Fold Rise) Compared to Prevaccination Level|Percentage of participants with a ≥ 4-fold rise in anti-meningococcal serum IgG levels against serotype C from prevaccination to 4 weeks after MCV4 vaccination.|Up to Week 4 (Day 28) postvaccination|One participant in the IFN group did not have an assessment.|||percentage of participants||95% Confidence Interval|Number
2606577|NCT02097849|Secondary|Percentage of Meningococcal Serogroup C Responders (≥ 2-Fold Rise) Compared to Prevaccination Level|Percentage of participants with a ≥ 2-fold rise in anti-meningococcal serum IgG levels against serotype C from prevaccination to 4 weeks after MCV4 vaccination.|Up to Week 4 (Day 28) postvaccination|One participant in the IFN group did not have an assessment.|||percentage of participants||95% Confidence Interval|Number
2606578|NCT02097849|Secondary|Percentage of Pneumococcal Serotype 8 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level|Percentage of participants with a ≥ 4-fold rise in anti-pneumococcal serum IgG levels against serotype 8 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.|Up to Week 4 (Day 28) postvaccination||||percentage of participants||95% Confidence Interval|Number
2606579|NCT02097849|Secondary|Percentage of Pneumococcal Serotype 8 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level|Percentage of participants with a ≥ 2-fold rise in anti-pneumococcal serum IgG levels against serotype 8 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.|Up to Week 4 (Day 28) postvaccination||||percentage of participants||95% Confidence Interval|Number
2606580|NCT02097849|Secondary|Percentage of Pneumococcal Serotype 3 (≥ 4-Fold Rise) Responders Compared to Prevaccination Level|Percentage of participants with a ≥ 4-fold rise in anti-pneumococcal serum IgG levels against serotype 3 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.|Up to Week 4 (Day 28) postvaccination||||percentage of participants||95% Confidence Interval|Number
2606581|NCT02097849|Secondary|Percentage of Pneumococcal Serotype 3 (≥ 2-Fold Rise) Responders Compared to Prevaccination Level|Percentage of participants with a ≥ 2-fold rise in anti-pneumococcal serum IgG levels against serotype 3 from prevaccination to 4 weeks (28 days) after PPSV23 vaccination.|Up to Week 4 (Day 28) postvaccination||||percentage of participants||95% Confidence Interval|Number
2606582|NCT02097849|Secondary|Percentage of Tetanus Responders (≥ 4-Fold Rise) at Day 28 Compared to Prevaccination Level|Percentage of participants with a ≥ 4-fold rise in anti-tetanus serum IgG levels (responders) from prevaccination to 4 weeks after Td vaccination.|Up to Week 4 (Day 28) postvaccination||||percentage of participants||95% Confidence Interval|Number
2606583|NCT02097849|Primary|Percentage of Tetanus Responders (≥ 2-Fold Rise) at Day 28 Compared to Prevaccination Level|Percentage of participants with a ≥ 2-fold rise in anti-tetanus serum immunoglobulin G (IgG) levels (responders) from prevaccination to 4 weeks after Td vaccination.|Up to Week 4 (Day 28) postvaccination||||percentage of participants||95% Confidence Interval|Number
2606584|NCT02097823|Other Pre-specified|Number of Participants With Adverse Events.|Olanzapine will be considered tolerable if less than 10% of patients experience a grade III or IV adverse event attributable to olanzapine.|Ongoing, throughout the study. Will be fully evaluated in approximately 1 year, at the conclusion of data collection. Each patient will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks.||||participants|||Number
2606585|NCT02097823|Secondary|Good Control of Nausea|"Good control of nausea will be ratings <25 on visual analog scale by parents and <2 on baxter retching faces scale by patients. Will look at the proportions of patients with good control of nausea.~The visual analog scale ranged from 0-100, with 0 being no nausea and 100 being very very severe nausea. The Baxter retching faces scale ranged from 0-10 using only even numbers (0,2,4,6,8,10) and each number has a corresponding face depicting someone experiencing varying levels of nausea, with 0 being no nausea and 10 being a picture of face vomiting."|Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.|could only analyze cycles where subjects had returned completed forms|||percentage of participant w/good control|||Number
2606586|NCT02097823|Secondary|Complete Response in Delayed Phase|This will measure what percentage of patients have a complete response (no emesis or use of breakthrough medications) in the delayed phase (25-120 hours).|Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.||||percentage of participants with CR|||Number
2606587|NCT02097823|Secondary|Complete Response in Acute Phase|This will measure what percentage of patients have a complete response (no emesis or use of breakthrough medications) in the acute phase (0-24 hours).|Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.||||percentage of participants with CR|||Number
2606588|NCT02097823|Secondary|Complete Response in Overall Phase|This will measure what percentage of patients have a complete response (no emesis or use of breakthrough medications) in the overall phase (0-120 hours).|Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.||||percentage of participants with CR|||Number
2606646|NCT02097472|Secondary|Fold Change in IgG Response to StkP Pneumococcal Protein|Measured using MSD|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
2606647|NCT02097472|Secondary|Fold Change in IgG Response to BCH0785 Pneumococcal Protein|Measured using MSD|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
2606589|NCT02097823|Primary|Feasibility of Recruitment and Data Collection.|Primary objective of this study is to determine the feasibility of recruitment and data collection for conducting a larger trial. Recruitment and data collection will be feasible if at least 20 subjects can be recruited in 1 year and there is a 90% form completion rate.|Approximately 1 year after study opens, at the conclusion of data collection. Participants will be followed during 2 cycles of chemotherapy, an expected average of 6 weeks. Data will be collected over 5 days during each cycle.||||percentage of completed forms|Administered forms||Number
2606590|NCT02097745|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Year 5|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2606591|NCT02097745|Secondary|Change From Baseline in the Genant-modified Sharp Joint Space Narrowing Score at Year 5|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score joint space narrowing of 0-4 (9 gradations) is assigned to 13 joints in each hand and 6 joints in each foot. The maximum joint space narrowing score is 38 x 4.0 = 152 which is normalized to a score of 145. The minimum score is 0 and the maximum score is 145. A higher score indicates more damage. A negative change score indicates improvement. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2606592|NCT02097745|Secondary|Change From Baseline in the Genant-modified Sharp Erosion Score at Year 5|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140 which is normalized to 145. The minimum score is 0 and the maximum score is 145. A higher score indicates more damage. A negative change score indicates improvement. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2606593|NCT02097745|Secondary|Change From Baseline in the Total Genant-modified Sharp Score at Year 5|The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. Joint space narrowing scores of 0-4 (9 gradations) are assigned to 13 joints in each hand and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140. The maximum joint space narrowing score is 38 x 4.0 = 152. Both the erosion and joint space narrowing scores are normalized to 145 and are added together for a maximum total Genant-modified Sharp score of 290; the minimum score is 0. A higher score indicates more damage. A negative change score indicates improvement. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.|||Units on a scale||Standard Deviation|Mean
2606594|NCT02097745|Secondary|Percentage of Participants With no Radiographic Progression From Baseline to Year 5|Radiographic progression was defined as a change of ≤ 0 in the total Genant-modified Sharp score. The Genant-modified Sharp scoring system assesses structural damage due to rheumatoid arthritis in radiographs. A score for erosions of 0-3.5 (8 gradations) is assigned for 14 joints in each hand and wrist, and 6 joints in each foot. Joint space narrowing scores of 0-4 (9 gradations) are assigned to 13 joints in each hand and 6 joints in each foot. The maximum erosion score is 40 x 3.5 = 140. The maximum joint space narrowing score is 38 x 4.0 = 152. Both the erosion and joint space narrowing scores are normalized to 145 and are added together for a maximum total Genant-modified Sharp score of 290; the minimum score is 0. A higher score indicates more damage. Data is reported for 2 groups.|Baseline to Year 5|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531. Only participants who had radiographs available at Baseline and Year 5 were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
2606595|NCT02097745|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score|The FACIT-F is a 13-item participant self-reporting questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A negative change score indicates improvement.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.|||Units on a scale||Standard Deviation|Mean
2606596|NCT02097745|Secondary|Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey|The SF-36 Health Survey uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A positive change score indicates an improvement in HRQoL.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.|||Units on a scale||Standard Deviation|Mean
2606648|NCT02097472|Secondary|Fold Change in IgG Response to PhtD Pneumococcal Protein|Measured using MSD|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
2606649|NCT02097472|Secondary|Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD)|Measured using MSD|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
2606597|NCT02097745|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.|||Units on a scale||Standard Deviation|Mean
2606598|NCT02097745|Secondary|Change From Baseline in the American College of Rheumatology n (ACRn) Response|The ACRn response was defined as each participant's least favorable percentage change from Baseline in 3 measures, tender joint count, swollen joint count (28 assessed joints), and improvement score achieved in at least 3 of the 5 remaining ACR parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity, right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain, right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate). A higher change percentage indicates greater improvement from Baseline. The ACRn response was compared to Baseline in the precursor study WA17042. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.|||Percentage change||Standard Deviation|Mean
2606599|NCT02097745|Secondary|Percentage of Participants With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses|Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.|||Percentage of participants|||Number
2606600|NCT02097745|Secondary|Percentage of Participants With DAS28 Low Disease Activity and DAS28 Remission|The DAS28 is an index for measuring disease activity in rheumatic arthritis and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low disease activity was defined as a DAS28 score ≤ 3.2. DAS28 remission was defined as a DAS28 score < 2.6. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.|||Percentage of participants|||Number
2606601|NCT02097745|Secondary|Change From Baseline in the Disease Activity Score 28 (DAS28)|The DAS28 is an index for measuring disease activity in rheumatic arthritis and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where a higher score represents higher disease activity. A negative change score indicates improvement. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.|||Units on a scale||Standard Deviation|Mean
2606602|NCT02097745|Primary|Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response|A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity [symptom-free and no arthritis symptoms], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain and right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate). The ACR20 response was compared to Baseline in the precursor study WA17042. The first retreatment may have occurred in the precursor study WA17042.|Baseline to the end of the retreatment period (up to 7 years, 6 months)|Intent-to-treat population: All participants who received any part of an infusion of study medication in study WA17531.|||Percentage of participants|||Number
2606603|NCT02097732|Other Pre-specified|Immune Correlates|Exploratory endpoints: Interval changes in immune markers in the blood|6 months|||||||
2606604|NCT02097732|Other Pre-specified|Imaging Correlates on Dynamic-contrast Enhanced MRI of the Brain|Exploratory endpoints: Interval changes in dynamic MRI parameters such as perfusion, blood volume, vascular permeability (Ktrans), and diffusion tensor imaging; the change in 3D tumor volume.|6 months|||||||
2606650|NCT02097472|Secondary|Fold Change in IgG Response to L460D Pneumococcal Protein (MSD)|Measured using MSD|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
2606605|NCT02097732|Secondary|Time to Progression|Time to progression in the brain due to treated metastases or new brain metastases. Immune-related Response Evaluation Criteria In Solid Tumors (irRECIST) was used to assess response. Progression was defined as an increase in tumor burden ≥25% relative to nadir (minimum recorded tumor burden), with confirmation by a repeat, consecutive assessment no less than 4 wk from the date first documented.|From date of enrollment to up to 2 years|Of the 4 patients, 2 patients remained progression-free throughout the 2-year time frame for data collection for this outcome measure.|||participants|||Number
2606606|NCT02097732|Secondary|Intracranial Response Rate|Response of treated (irradiated) brain metastases to combination therapy with ipilimumab and stereotactic radiosurgery using immune-related response criteria.|Up to 12 months||||Participants|||Count of Participants
2606607|NCT02097732|Secondary|Regional (Intracranial) Control Rate|The proportion of patients in each arm who are free from progression in the index (radiated) lesions and free from new brain metastases at 6 months.|6 months||||Participants|||Count of Participants
2606608|NCT02097732|Secondary|Overall Survival Rate||Up to 5 years||2021-06-30|06/2021||||
2606609|NCT02097732|Primary|Local Control Rate|"The number of patients in each arm who are free from progression in the index (radiated) lesions in the brain at 6 months.~Immune related response criteria was used to assess response to treatment. Immune-related Progressive Disease (irPD) in this trial is defined as an increase in tumor burden ≥25% relative to nadir (minimum recorded tumor burden), with confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented."|6 months||||Participants|||Count of Participants
2606610|NCT02097719|Primary|Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM|IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.|Week 12 at 8 AM, 12 PM, and 4 PM|Intent-to-Treat: all subjects who were randomized to study medication with data at the noted time point|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2606611|NCT02097641|Secondary|RAGE Change From Baseline to 24 h|Biological markers of alveolar epithelial injury: receptor for advanced glycation end products (RAGE)|baseline and 24 hours|The values were not available in two patients treated with hMSC and two patients treated with placebo.|||pg/mL||Inter-Quartile Range|Median
2606612|NCT02097641|Secondary|RAGE Change From Baseline to 6 h|Biological markers of alveolar epithelial injury: receptor for advanced glycation end products (RAGE)|baseline and 6 hours|The values were not available in one patient treated with hMSC and one patient treated with placebo.|||pg/mL||Inter-Quartile Range|Median
2606613|NCT02097641|Secondary|Interleukin 8 Change From Baseline to 24 h|Biological markers of inflammation: interleukin 8|baseline and 24 hours|The values were not available in two patients treated with hMSC and two patients treated with placebo.|||pg/mL||Inter-Quartile Range|Median
2606614|NCT02097641|Secondary|Interleukin 8 Change From Baseline to 6 h|Biological markers of inflammation: interleukin 8|baseline and 6 hours|The values were not available in one patient treated with hMSC and one patient treated with placebo.|||pg/mL||Inter-Quartile Range|Median
2606615|NCT02097641|Secondary|Interleukin 6 Change From Baseline to 24 h|Biological markers of inflammation: interleukin 6|baseline and 24 hours|The values were not available in two patients treated with hMSC and two patients treated with placebo.|||pg/mL||Inter-Quartile Range|Median
2606616|NCT02097641|Secondary|Interleukin 6 Change From Baseline to 6 h|Biological markers of inflammation: interleukin 6|baseline and 6 hours|The values were not available in one patient treated with hMSC and one patient treated with placebo.|||pg/mL||Inter-Quartile Range|Median
2606617|NCT02097641|Secondary|Angiopoietin 2 Change From Baseline to 24 h|Biological markers of endothelial injury: angiopoietin 2|baseline and 24 hours|The values were not available in two patients treated with hMSC and two patients treated with placebo.|||pg/mL||Inter-Quartile Range|Median
2606618|NCT02097641|Secondary|Angiopoietin 2 Change From Baseline to 6 h|Biological markers of endothelial injury: angiopoietin 2|baseline and 6 hours|The biomarker values were missing in one patient treated with hMSC and one patient treated with placebo.|||pg/mL||Inter-Quartile Range|Median
2606619|NCT02097641|Secondary|Non-pulmonary Organ-failure-free Days to Day 28|Efficacy endpoint: Non-pulmonary organ-failure-free days to day 28|28 days||||days||Inter-Quartile Range|Median
2606620|NCT02097641|Secondary|Number of Ventilator-free Days to Day 28|Efficacy endpoint: Number of ventilator-free days to day 28.|28 days||||days||Inter-Quartile Range|Median
2606621|NCT02097641|Secondary|Mortality to Day 60|Efficacy endpoint: all-cause mortality at day 60|60 days||||Participants|||Count of Participants
2606622|NCT02097641|Secondary|Number of Patients Death to Day 28|Efficacy endpoint: all-cause mortality at day 28|28 days||||Participants|||Count of Participants
2606623|NCT02097641|Secondary|SOFA Score Change From Baseline to Day 3|Sequential organ failure assessment score (SOFA). The SOFA score ranges from 0 to 24. The higher, the worse.|baseline and day 3|The values were missing in 3 MSC patients and 1 placebo patient.|||units on a scale||Inter-Quartile Range|Median
2606624|NCT02097641|Secondary|Oxygenation Index Change From Baseline to Day 2|Oxygenation index with the following validated measure of respiratory function: FiO2 (%) x mean airway pressure / PaO2|baseline and day 2|The values were missing in 16 patients treated by MSC and 6 patients treated by placebo|||kPa||Inter-Quartile Range|Median
2606625|NCT02097641|Secondary|Lung Injury Score From Baseline to Day 3|Murray score for acute lung injury. The range is 0 to 4. The higher score, the worst outcome.|baseline and day 3|The values were missing in 9 hMSC patients and 2 placebo patients.|||units on a scale||Inter-Quartile Range|Median
2606626|NCT02097641|Secondary|PaO2:FiO2 Change From Baseline to Day 3|Efficacy endpoint: PaO2:FiO2 change from baseline to day 3|baseline and day 3|The values of PaO2:FiO2 were not available in 10 patients treated with hMSCs and in 2 patients treated with placebo.|||kPa||Inter-Quartile Range|Median
2606627|NCT02097641|Primary|Numbers of Patients Occurred Any Unexpected Severe Adverse Events (Including All-cause Deaths)|Safety endpoint: Any unexpected severe adverse events in two groups|12 months||||Participants|||Count of Participants
2606628|NCT02097641|Primary|Numbers of Patients Occurred Any Cardiac Arrest or Death Within 24 Hours of Study Infusion|"Within 24 h of study product infusion~• Any cardiac arrest or death"|24 hours||||Participants|||Count of Participants
2606733|NCT02097108|Secondary|Total Cholesterol Baseline and After 24 Weeks||baseline to week 24||||mg/dl||Standard Deviation|Mean
2606629|NCT02097641|Primary|Numbers of Patients Occurred Pre-specified Infusion Associated Events Occurring Within 6 Hours of Study Infusion|"Within 6 h of study product infusion:~Increase in vasopressor dose to the following values or higher:~Norepinephrine 10 μg/min~Phenylephrine 100 μg/min~Dopamine 10 μg/kg per min~Epinephrine 0.1 μg/kg per min or addition of a third vasopressor~New ventricular tachycardia, ventricular fibrillation or asystole~New cardiac arrhythmia requiring cardioversion~Hypoxaemia requiring an increase in FiO2 of 0·2 or more and an increase in PEEP of 5·0 or more to maintain SpO2 in the target range of 88-95%~Clinical scenario consistent with transfusion incompatibility or transfusion-related infection (eg, urticaria, new bronchospasm)"|6 hours||||Participants|||Count of Participants
2606630|NCT02097537|Secondary|The Summary Statistics of PC20|PC20 : the concentration of methacholine causing 20% fall in FEV1.|Visit 1 (Day 1)||||mg/mL||Standard Deviation|Mean
2606631|NCT02097537|Secondary|The Rate of Subjects Whose FEV1 Falls More Than 20% From Baseline Before the Highest Concentration Inhalation||Visit 1 (Day 1)||||percentage of the subjects|||Number
2606632|NCT02097537|Primary|The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL|"The methacholine challenge test is for assessment of bronchial sensitivity, it is assessed by FEV1 (Forced Expiratory Volume in one second) with spirometer.~For measurement of FEV1, a patient is inhaled saline as baseline and each dose of methacholine which be gradually diluted, inhalations are discontinued with a drop in FEV1 of 20% or more.~The concentration of methacholine causing 20% fall in FEV1 is PC20."|Visit 1 (Day 1)||||percentage of the subjects|||Number
2606633|NCT02097472|Other Pre-specified|Geometric Mean Concentration (GMC) Ratio of Tetanus Booster Immune Response Among Toddler Subjects|GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.|12 weeks post vaccination 1|The number analyzed may differ between proteins because of insufficient samples.|||IU/mL||90% Confidence Interval|Geometric Mean
2606634|NCT02097472|Other Pre-specified|Geometric Mean Concentration (GMC) Ratio of Pertussis Fimbriae Immune Response Among Toddler Subjects|GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.|12 weeks post vaccination 1|The number analyzed may differ between proteins because of insufficient samples.|||U/mL||90% Confidence Interval|Geometric Mean
2606635|NCT02097472|Other Pre-specified|Geometric Mean Concentration (GMC) Ratio of Pertussis FHA and Pertussis Toxin Immune Response Among Toddler Subjects|GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.|12 weeks post vaccination 1|The number analyzed may differ between proteins because of insufficient samples.|||IU/mL||90% Confidence Interval|Geometric Mean
2606636|NCT02097472|Other Pre-specified|Geometric Mean Concentration (GMC) Ratio of Haemophilus Influenzae Type b (Hib) Booster Immune Response Among Toddler Subjects|GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.|12 weeks post vaccination 1|The number analyzed may differ between proteins because of insufficient samples.|||ug/mL||90% Confidence Interval|Geometric Mean
2606637|NCT02097472|Other Pre-specified|Geometric Mean Concentration (GMC) Ratio of Hepatitis B Booster Immune Response Among Toddler Subjects|GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.|12 weeks post vaccination 1|The number analyzed may differ between proteins because of insufficient samples.|||mIU/mL||90% Confidence Interval|Geometric Mean
2606638|NCT02097472|Other Pre-specified|Geometric Mean Concentration (GMC) Ratio of Diptheria Booster Immune Response Among Toddler Subjects|GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.|12 weeks post vaccination 1|The number analyzed may differ between proteins because of insufficient samples.|||IU/mL||90% Confidence Interval|Geometric Mean
2606639|NCT02097472|Other Pre-specified|Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects|GMCs of these IgG proteins were measured to assess potential interference of PATH-wSP with 10-valent pneumococcal conjugate vaccine (Synflorix). GMCs of Cohort 1 were measured at a different time point than those in Cohort 2, so results are presented separately.|12 weeks (Cohort 1) and 4 weeks (Cohort 2) post-vaccination 1|The number analyzed may differ between proteins because of insufficient samples.|||ug/mL||90% Confidence Interval|Geometric Mean
2606640|NCT02097472|Secondary|Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin|Functional antibody responses to Ply (pneumolysin) were assessed using a toxin neutralization assay based on the ability of antibodies to neutralize wild-type Ply-induced lysis of rabbit red blood cells. Briefly, serial 2-fold dilutions (starting at 1/5 dilution) of human serum samples were added together with wild-type Ply in 96-well plates. Rabbit red blood cells were then added and following incubation supernatants removed and transferred to new 96-well plates and absorbance measured at 540 nm using a spectrophotometer plate reader. The mean A450 nm blank value was subtracted by 10% to obtain the Plate Specific Cut Point for each plate. Each sample was categorized as negative (<1/20) or positive (with titer between 1/20 and 1/320).|0 days, 28 days (Dose 1) and 56 days (Dose 2)||||Participants|||Count of Participants
2606641|NCT02097472|Secondary|Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin|Functional antibody responses to Ply (pneumolysin) were assessed using a toxin neutralization assay based on the ability of antibodies to neutralize wild-type Ply-induced lysis of rabbit red blood cells. Briefly, serial 2-fold dilutions (starting at 1/5 dilution) of human serum samples were added together with wild-type Ply in 96-well plates. Rabbit red blood cells were then added and following incubation supernatants removed and transferred to new 96-well plates and absorbance measured at 540 nm using a spectrophotometer plate reader. The mean A450 nm blank value was subtracted by 10% to obtain the Plate Specific Cut Point for each plate. Each sample was categorized as negative (<1/20) or positive (with titer between 1/20 and 1/320).|0 days, 28 days (Dose 1) and 56 days (Dose 2)||||Participants|||Count of Participants
2606642|NCT02097472|Secondary|Fold Change in IgG Response to PiaA Pneumococcal Protein|Measured using MSD|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
2606643|NCT02097472|Secondary|Fold Change in IgG Response to PiuA Pneumococcal Protein|Measured using MSD|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
2606644|NCT02097472|Secondary|Fold Change in IgG Response to SPWCA Pneumococcal Protein|Measured using MSD|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
2606645|NCT02097472|Secondary|Fold Change in IgG Response to PcpA Pneumococcal Protein|Measured using MSD|28 days (post-vaccination 1) and 56 days (post-vaccination 2)||||Participants|||Count of Participants
2606659|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein|Measured using MSD|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
2606660|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD|Measured using ELISA|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
2606661|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD|Measured using MSD|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
2606662|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA|Measured using ELISA|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
2606663|NCT02097472|Secondary|Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA|Measured using ELISA|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||fold change||90% Confidence Interval|Geometric Mean
2606664|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein|MSD Assay|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||titer||90% Confidence Interval|Geometric Mean
2606665|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein|MSD Assay|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||titer||90% Confidence Interval|Geometric Mean
2606666|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein|MSD Assay|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||titer||90% Confidence Interval|Geometric Mean
2606667|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein|Measured using Meso Scale Discovery (MSD) Assay|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||titer||90% Confidence Interval|Geometric Mean
2606668|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein|Measured using Meso Scale Discovery (MSD) Assay|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||titer||90% Confidence Interval|Geometric Mean
2606669|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein|Measured using Meso Scale Discovery (MSD) Assay|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||titer||90% Confidence Interval|Geometric Mean
2606670|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein|Measured using Meso Scale Discovery (MSD) Assay|0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||titer||90% Confidence Interval|Geometric Mean
2606671|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay||0 days, 28 days (Dose 1) and 56 days (Dose 2)|The number analyzed may differ between periods because of insufficient samples.|||titer||90% Confidence Interval|Geometric Mean
2606672|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein|Measured using meso scale discovery (MSD).|0 days, 28 days (Dose 1) and 56 days (Dose 2)|Insufficient sample|||titer||90% Confidence Interval|Geometric Mean
2606673|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay|Measured with enzyme-linked immunosorbent assay (ELISA).|0 days, 28 days (Dose 1) and 56 days (Dose 2)||||titer||90% Confidence Interval|Geometric Mean
2606674|NCT02097472|Secondary|Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay|Measured with enzyme-linked immunosorbent assay (ELISA).|0 days, 28 days (Dose 1) and 56 days (Dose 2)||||titer||90% Confidence Interval|Geometric Mean
2606675|NCT02097472|Primary|Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
2606676|NCT02097472|Primary|Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
2606677|NCT02097472|Primary|Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
2606678|NCT02097472|Primary|Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
2607619|NCT02085785|Secondary|Change in 6-minute Walk Distance|Change in 6-minute walk distance (ft) from baseline to follow-up|Baseline and at follow-up assessment (20-weeks after randomization)|Baseline carried forward if 20-week follow-up data not collected|||feet||95% Confidence Interval|Mean
2606679|NCT02097472|Primary|Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
2606680|NCT02097472|Primary|Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination|"Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.~Grade 2: includes diffuse macular/maculopapular/morbilliform rash"|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
2606681|NCT02097472|Primary|Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
2606682|NCT02097472|Primary|Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
2606683|NCT02097472|Primary|Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination|"Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.~Grade 1: does not interfere with activity Grade 2: interferes with activity"|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
2606684|NCT02097472|Primary|Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
2606685|NCT02097472|Primary|Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination|"Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.~Grade 2 includes use of non-narcotic pain reliever for more than 24 hours."|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
2606686|NCT02097472|Primary|Number/Percent of Adult Subjects Experiencing Headache Following Vaccination|"Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.~Grade 2 includes repeated use of non-narcotic pain reliever for more than 24 hours."|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
2606687|NCT02097472|Primary|Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
2606688|NCT02097472|Primary|Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination|Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.|up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)||||Participants|||Count of Participants
2606689|NCT02097303|Other Pre-specified|Overall Response Rate|Determination of measurable disease progression or response was based on modified RECIST criteria. Reported is the number of participants with either a partial or complete response, and who had radiological extraskeletal progression.|Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline||||Participants|||Count of Participants
2606690|NCT02097303|Primary|Number and Percentage of Participants With Clinically Meaningful Improvement (CMI) in Pain (Between Baseline and End of Treatment)|"Improvement in Bone Pain was assessed using the Bone Pain Inventory (BPI)~Pain Severity: Pain severity is the composite of scores of worst pain, least pain, average pain, and pain now. CMI criteria: Decrease >30% at two consecutive visits in Pain Severity Score in 24 hours without an increase in analgesic use.~Pain interference: Pain interference is the composite scores on general activity, mood, walking ability, normal work, relationships with others, sleep and enjoyment of life. CMI criteria: Decrease by 1.25 points or more compared with baseline at two consecutive visits.~Transient Pain Flare: Based on the work of Atkinson et al, a transient pain flare was assessed by pain at its worst in 24 hours. CMI criteria: > 2 points on the BPI-SF Worst Pain scale and subsequent reduction after initiation of Ra-223 and during the first 3 cycles."|Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects.||||Participants|||Count of Participants
2606691|NCT02097303|Other Pre-specified|Bone Imaging Response (Number of Participants With Progression and Stable Disease)|Bone imaging response was assessed at baseline and at EOT visit. Progression was defined as two or more additional lesions in comparison to the baseline.|Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline||||Participants|||Count of Participants
2606692|NCT02097303|Secondary|Radiologic Assessment Mean Number of Bone Lesions Before and After the Treatment|[Not Specified]|Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline||||Lesions||Standard Deviation|Mean
2606693|NCT02097303|Secondary|Alkaline Phosphatase (ALP) and Prostate Specific Antigen (PSA) Levels Before and After Treatment|[Not specified]|Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline||||ng/dL||Standard Deviation|Mean
2606788|NCT02096705|Secondary|Adjusted Mean Change in Body Weight From Baseline to Week 24|Adjusted mean change in body weight from baseline to week 24 was reported for each arm in kilograms (kg).|Baseline (Day 1) and 24 weeks|All randomized participants with non-missing baseline and at least one post-baseline value|||kilograms||Standard Error|Mean
2606694|NCT02097303|Secondary|Safety Data Was Analyzed and Summarized in Subjects Who Receive at Least One Infusion of Radium Ra 223 Dichloride. Number of Adverse Events Are Being Reported.|All adverse events relevant to advanced mCRPC subjects as well as adverse events of interest for both Abiraterone Acetate plus Prednisone and Radium Ra 223 dichloride will be reported.|Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects.||||Adverse Events|||Number
2606695|NCT02097303|Primary|Number and Percentage of Participants With Clinically Meaningful Improvement (Between Baseline and End of Treatment) in Quality-of-Life Determined by the Minimum Increase From Baseline in Scores as Per the QOL CMI Criteria|"Following Quality of Life questionnaires were given at each visit:~FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the PCS (Range 1-156, higher scores better).~The FACT-General (FACT-G) is a 28 item QOL measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), Emotional (0-24) Well-being, and Satisfaction with Treatment was not assessed for this study (The total range was between 1-108, higher scores better)~FACT-TOI is derived from the sum of the Physical Well-Being, Functional Well-Being, and Prostate Cancer subscale scores; a sensitive measure of patient-reported health (Range 1-104, higher scores better)~PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better)."|Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects.|Improvement at the EOT visit was defined as increase from baseline of >= 10 points for FACT-P Total Scale. >9 points for FACT-G Total and FACT-TOI scales, and >=3 points for the remaining scales.|||Participants|||Count of Participants
2606696|NCT02097290|Secondary|LVAT Secondary Efficacy Endpoint: The Percent of LVAT Commanded Tests That Result in an Appropriate Outcome|"This endpoint will evaluate the percent of LVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test:~A device-determined threshold~A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests~A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the LVAT feature and might not occur in manual threshold tests An appropriate LVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the LVAT feature and could occur in the manual threshold tests. An inappropriate LVAT outcome consists of the last of the three outcomes listed above."|3-month follow up visit|A total of 182 unique subjects in whom a paired LVAT dataset was collected at the 3-month follow up visit. A paired dataset consisted of an LVAT threshold test outcome and core lab determined threshold test outcome.|||percentage of appropriate outcome||95% Confidence Interval|Number
2606697|NCT02097290|Secondary|RVAT Secondary Efficacy Endpoint: The Percent of RVAT Commanded Tests That Result in an Appropriate Outcome|"This endpoint will evaluate the percent of RVAT commanded tests that result in an appropriate outcome. There are three possible outcomes to a commanded test:~A device-determined threshold~A threshold test code (indicating that a threshold could not be determined) representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests~A threshold test code (indicating that a threshold could not be determined) that was due to a limitation of the RVAT feature and might not occur in manual threshold tests An appropriate RVAT outcome consists of the first two outcomes listed above: a device-determined threshold and a threshold test code representing an error condition that is beyond the control of the RVAT feature and could occur in the manual threshold tests. An inappropriate RVAT outcome consists of the last of the three outcomes listed above."|3-month follow up visit|A total of 157 unique subjects in whom a paired RVAT dataset was collected at the 3-month follow up visit. A paired dataset consisted of an RVAT threshold test outcome and core lab determined threshold test outcome.|||percentage of appropriate outcome||95% Confidence Interval|Number
2606698|NCT02097290|Primary|The Accuracy of the LVAT Ambulatory Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold|"Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by: |Ambulatory threshold - ECG threshold| ≤ 1.0 V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis."|1-month and 3-month follow up visits|A total of 300 paired datasets (from 175 unique subjects in whom LVAT threshold was available), each dataset consisting of a ambulatory LVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.|||Percentage of accurate threshold|LVAT ambulatory threshold paired dataset|95% Confidence Interval|Number
2606699|NCT02097290|Primary|The Accuracy of the RVAT Ambulatory Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold|"Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits.The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate Ambulatory threshold is defined by:|Ambulatory threshold - ECG threshold| ≤ 0.6 V; if the ECG threshold is ≤ 3.5V or |Ambulatory threshold - ECG threshold| ≤ 1.0 V; if the ECG threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets form the 1-month and 3-month visits were pooled for purposes of endpoint analysis."|1-month and 3-month follow up visits|A total of 314 paired datasets (from 183 unique subjects in whom RVAT threshold was available), each dataset consisting of an ambulatory RVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.|||Percentage of RVAT ambulatory thresholds|RVAT ambulatory threshold paired dataset|95% Confidence Interval|Number
2606700|NCT02097290|Primary|The Accuracy of the LVAT Commanded Test Will be Evaluated by Comparing the LVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.|"Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The LVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: commanded threshold - core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold - core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis."|1-month and 3-month follow up visits|A total of 324 paired datasets (from 182 unique subjects in whom LVAT threshold was available), each dataset consisting of a commanded LVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.|||Percentage of commanded LVAT thresholds|Commanded LVAT thresholds-paired dataset|95% Confidence Interval|Number
2606701|NCT02097290|Primary|The Accuracy of the RVAT Commanded Test Will be Evaluated by Comparing the RVAT Determined Threshold to a Core Lab (Independent Physician) Determined Threshold.|"Accuracy of the algorithm will be measured for all patients, by comparing algorithm determined threshold to a core lab determined threshold at both the 1-month and 3-month follow-up visits. The RVAT determined threshold for all patients at 1-month and 3-month follow-up visits are pooled for final analysis. An accurate commanded threshold is defined by: |commanded threshold - core lab determined threshold| ≤ 0.2 V; if the commanded threshold is ≤ 3.5V or |commanded threshold - core lab determined threshold| ≤ 0.5 V; if the commanded threshold is > 3.5V. Subjects were allowed to contribute multiple paired datasets for this endpoint analysis, one set each from the 1-month and 3-month visits. Paired datasets from the 1-month and 3-month visits were pooled for the purpose of this endpoint analysis."|1-month and 3-month follow-up visits|A total of 288 paired datasets (from 171 unique subjects in whom RVAT threshold was available), each dataset consisting of a commanded RVAT threshold and a core lab determined threshold, were collected at the 1-month and 3- month visits and pooled for final analysis.|||percentage of commanded RVAT thresholds|Commanded RVAT thresholds paired dataset|95% Confidence Interval|Number
2606702|NCT02097290|Primary|Primary Safety Endpoint is to Evaluate the System-related Complication-free Rate|Safety of the AUTOGEN was evaluated by the system-related complication-free rate (CFR) at 3-months post-implant. The system consists of the implanted AUTOGEN CRT-D pulse generator, RA lead (if implanted), RV lead, and LV lead.|3 months|Implant + Attempt Subjects|||Percentage of participants||95% Confidence Interval|Number
2606703|NCT02097277|Secondary|Percentage of Participants With ANTI-BMS-986036 Antibody Response|Percentage of Participants with ANTI-BMS-986036 Antibody Response (ADA positive and ADA Negative) was reported. Participants were monitored for antibodies to BMS-986036 with an anti-BMS-986036 antibody assay. Titers were reported for samples testing positive in an assay.|Baseline and Day 126|It included all treated participants who were randomized to treatment and subsequently received at least one dose of study medication.|||Percentage of participants|||Number
2606704|NCT02097277|Secondary|Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of Total BMS-986036|AUC [0-168 hours, ss] of Total BMS- 986036 was reported.|Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)|Serum concentration-time data will be used to develop a population PK model, and estimates of individual PK parameters will be derived from this model using a validated PK analysis program. Here, 'N' signifies number of participants evaluable for this outcome measure.|||hour*microgram/liter||Geometric Coefficient of Variation|Geometric Mean
2606705|NCT02097277|Secondary|Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) Total BMS-986036|AUC [0-24 hours, ss] of Total BMS-986036 was reported.|Pre-dose, 6, 24 hours postdose on Week 8|Serum concentration-time data will be used to develop a population PK model, and estimates of individual PK parameters will be derived from this model using a validated PK analysis program. Here, 'N' signifies number of participants evaluable for this outcome measure.|||hour*microgram/liter||Geometric Coefficient of Variation|Geometric Mean
2606706|NCT02097277|Secondary|Maximum Observed Concentration (Cmax) of Total BMS-986036|Maximum observed concentration (Cmax) of Total BMS-986036 was reported.|Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)|Serum concentration-time data will be used to develop a population PK model, and estimates of individual PK parameters will be derived from this model using a validated PK analysis program. Here, 'N' signifies number of participants evaluable for this outcome measure.|||microgram/liter||Geometric Coefficient of Variation|Geometric Mean
2606707|NCT02097277|Secondary|Average Concentration (Cavg) of Total BMS-986036|Cavg of Total BMS-986036 was reported.|Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)|Serum concentration-time data will be used to develop a population PK model, and estimates of individual PK parameters will be derived from this model using a validated PK analysis program. Here, 'N' signifies number of participants evaluable for this outcome measure.|||Microgram per Liter (ug/L)||Geometric Coefficient of Variation|Geometric Mean
2606708|NCT02097277|Secondary|Area Under the Concentration-time Curve From Time Zero to 168 Hours at Steady State (AUC [0-168 Hours, ss]) of C-terminal Intact BMS-986036|AUC [0-168 hours, ss] of C-terminal Intact BMS-986036 was reported.|Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)|Serum concentration-time data will be used to develop a population PK model, and estimates of individual PK parameters will be derived from this model using a validated PK analysis program. Here, 'N' signifies number of participants evaluable for this outcome measure.|||hour*microgram/liter||Geometric Coefficient of Variation|Geometric Mean
2606745|NCT02097030|Secondary|Overall Satisfaction|Participant's subjective response for overall satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||participants|||Number
2606709|NCT02097277|Secondary|Area Under the Concentration-time Curve From Time Zero to 24 Hours at Steady State (AUC [0-24 Hours, ss]) of C-terminal Intact BMS-986036|AUC [0-24 hours, ss] of C-terminal Intact BMS-986036 was reported.|Pre-dose, 6, 24 hours postdose on Week 8|Serum concentration-time data will be used to develop a population PK model, and estimates of individual PK parameters will be derived from this model using a validated PK analysis program. Here, 'N' signifies number of participants evaluable for this outcome measure.|||hour*microgram/liter||Geometric Coefficient of Variation|Geometric Mean
2606710|NCT02097277|Secondary|Maximum Observed Concentration (Cmax) of C-terminal Intact BMS-986036|Maximum observed concentration (Cmax) of C-terminal Intact BMS-986036 was reported.|Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)|Serum concentration-time data will be used to develop a population PK model, and estimates of individual PK parameters will be derived from this model using a validated PK analysis program. Here, 'N' signifies number of participants evaluable for this outcome measure.|||microgram/liter||Geometric Coefficient of Variation|Geometric Mean
2606711|NCT02097277|Secondary|Average Concentration (Cavg) of C-terminal Intact BMS-986036|Cavg of C-terminal Intact BMS-986036 was reported.|Pre-dose, 6, 24 hours postdose on Week 8; pre-dose on Weeks 1, 2, 4, 6, 8, and 12; post treatment period on Week 13, 15 and 18 (Day 126)|Serum concentration-time data will be used to develop a population PK model, and estimates of individual PK parameters will be derived from this model using a validated PK analysis program. Here, 'N' signifies number of participants evaluable for this outcome measure.|||Microgram per Liter (ug/L)||Geometric Coefficient of Variation|Geometric Mean
2606712|NCT02097277|Secondary|Change in OGTT C-peptide AUC (0-2 Hours) From Baseline to Week 12|Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. C-peptide levels over 2 hours were shown as Area Under the Curve, (AUC).|Baseline (Day 1) and Week 12|The Pharmacodynamic Population included all participants who received at least one dose of study medication and had PD biomarker data available, although only participants with both baseline and post-baseline data were included in the statistical analysis. Here, 'N' signifies number of participants analyzed for this outcome measure.|||mmol*hr/L||Standard Deviation|Mean
2606713|NCT02097277|Secondary|Change in OGTT Insulin AUC (0-2 Hours) From Baseline to Week 12|Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. Insulin levels over 2 hours were shown as Area Under the Curve, (AUC).|Bseline (Day 1) and Week 12|The Pharmacodynamic Population included all participants who received at least one dose of study medication and had PD biomarker data available, although only participants with both baseline and post-baseline data were included in the statistical analysis. Here, 'N' signifies number of participants analyzed for this outcome measure.|||mmol*hr/L||Standard Deviation|Mean
2606714|NCT02097277|Secondary|Change in Oral Glucose Tolerance Test (OGTT) Area Under the Curve From 0 to 2 Hours for Postprandial Glucose From Baseline to Week 12|Blood samples were drawn after an overnight fast and standard OGTT from 0 to 120 minutes. Plasma Glucose levels over 2 hours were shown as Area Under the Curve, (AUC).|Baseline (Day 1) and Week 12|The Pharmacodynamic Population included all participants who received at least one dose of study medication and had PD biomarker data available, although only participants with both baseline and post-baseline data were included in the statistical analysis. Here, 'N' signifies number of participants analyzed for this outcome measure.|||Millimole*hour per Liter (mmol*hr/L)||Standard Deviation|Mean
2606715|NCT02097277|Secondary|Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Quantitative Insulin Sensitivity Check Index (QUICKI)|The Quantitative Insulin Sensitivity Check Index (QUICKI) score, measures insulin sensitivity which is the inverse of insulin resistance. QUICKI is derived using the inverse of the sum of the logarithms of the fasting insulin and fasting glucose: 1 / (log(fasting insulin mU/L) + log(fasting glucose mg/dL)).|Baseline (Day 1) and Week 12|The Pharmacodynamic Population included all subjects who received at least one dose of study medication and had PD biomarker data available, although only participants with both baseline and post-baseline data were included in the statistical analysis. Here, 'N' signifies number of participants analyzed for this outcome measure.|||Unit on a scale||Standard Deviation|Mean
2606716|NCT02097277|Secondary|Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)|Homeostasis model assessment of insulin resistance (HOMA-IR) was used as a validated measure of insulin resistance. HOMA-IR is calculated using the following formula's fasting glucose(mg/dL) x fasting insulin(mU/L) / 405.|Baseline (Day 1) and Week 12|The Pharmacodynamic Population included all participants who received at least one dose of study medication and had PD biomarker data available, although only participants with both baseline and post-baseline data were included in the statistical analysis. Here, 'N' signifies number of participants analyzed for this outcome measure.|||Unit on a Scale||Standard Deviation|Mean
2606717|NCT02097277|Secondary|Change From Baseline to Week 12 in Insulin Sensitivity Quantified by Composite Index of Insulin Sensitivity (CISI) (Matsuda Index)|Whole body insulin sensitivity as quantified by Matsuda Index at the end of the treatment period, calculated by the following equation: 10,000/square root of(FPG*FI)*(FPG+PG30*2+PG60*3+PG120*2)/8*(FPI+PI30*2+PI60*3+PI120*2)/8). FPG=fasting plasma glucose level; FPI=fasting plasma insulin level; PG30,60,90, and 120=plasma glucose levels sampled at 30,60, and 120 minutes after oral glucose load; PI30,60,and 120=plasma insulin levels sampled at 30,60 and 120 minutes after the oral glucose load.|Baseline (Day 1) and Week 12|The Pharmacodynamic Population included all participants who received at least one dose of study medication and had PD biomarker data available, although only participants with both baseline and post-baseline data were included in the statistical analysis. Here, 'N' signifies number of participants analyzed for this outcome measure.|||Unit on a scale||Standard Deviation|Mean
2606718|NCT02097277|Secondary|Change in Body Weight From Baseline to Week 12|Change in Body Weight from Baseline to Week 12 as a part of Physical measurement was reported.|Baseline (Day 1) and Week 12|The Pharmacodynamic Population included all subjects who received at least one dose of study medication and had PD biomarker data available, although only subjects with both baseline and post-baseline data were included in the statistical analysis. Here, 'N' signifies number of participants analyzed for this outcome measure.|||Kilogram||Standard Deviation|Mean
2606789|NCT02096705|Secondary|Adjusted Mean Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24|The adjusted mean change from baseline to 24 weeks in Fasting Plasma Glucose (FPG) was reported for each arm in milligrams per deciliter (mg/dL).|Baseline (Day 1) and 24 weeks|All randomized participants with non-missing baseline and at least one post-baseline value|||mg/dL||Standard Error|Mean
2606719|NCT02097277|Primary|Percent Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 12|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Percent Change in Glycosylated Hemoglobin A1c (HbA1c) from Baseline to Week 12 was reported.|Baseline (Day 1) and Week 12|The Pharmacodynamic Population included all subjects who received at least one dose of study medication and had PD biomarker data available, although only participants with both baseline and post-baseline data were included in the statistical analysis. Here, 'N' signifies number of participants analyzed for this outcome measure.|||Percent Change||Standard Deviation|Mean
2606720|NCT02097238|Secondary|A Half Life of Eribulin Mesylate in hr|Data from all patients who provide samples for pharmacokinetic analysis will be aggregated. The sample mean and variance of the half life will be reported. The analytic unit will be the patient-cycle: Each cycle where the patient receives eribulin and does not receive non-protocol anticancer therapy will be considered in the analysis.|1 day 1 and cycle 2 day 1 at the end of infusion, 0.5-6 hours, and 24-120 hours post infusion; cycle 1 day 8 and cycle 2 day 8 prior to the dose of eribulin and at the end of infusion|5 patients contributed 9 cycles for the calculation of the sample mean and standard deviation of half life|||hours|patient-cycles|Standard Deviation|Mean
2606721|NCT02097238|Secondary|Clearance of Eribulin Mesylate in L/hr|Data from all patients who provide samples for pharmacokinetic analysis will be aggregated. The sample mean and variance of the clearance will be reported. The analytic unit will be the patient-cycle: Each cycle where the patient receives eribulin and does not receive non-protocol anticancer therapy will be considered in the analysis.|Cycle 1 day 1 and cycle 2 day 1 at the end of infusion, 0.5-6 hours, and 24-120 hours post infusion; cycle 1 day 8 and cycle 2 day 8 prior to the dose of eribulin and at the end of infusion.|5 patients contributed 9 cycles for the calculation of the sample mean and standard deviation of clearance|||L/hour|patient-cycles|Standard Deviation|Mean
2606722|NCT02097238|Secondary|Area Under the Curve 0-infinity of Eribulin Mesylate in Ng-hr/ml|Data from all patients who provide samples for pharmacokinetic analysis will be aggregated. The sample mean and variance of the area under the curve will be reported The analytic unit will be the patient-cycle: Each cycle where the patient receives eribulin and does not receive non-protocol anticancer therapy will be considered in the analysis.|Cycle 1 day 1 and cycle 2 day 1 at the end of infusion, 0.5-6 hours, and 24-120 hours post infusion; cycle 1 day 8 and cycle 2 day 8 prior to the dose of eribulin and at the end of infusion|5 patients contributed 9 cycles for the calculation of the sample mean and standard deviation of Area under the curve|||hour-nanograms/mL|patient-cycles|Standard Deviation|Mean
2606723|NCT02097238|Secondary|Number of Cycles Where a Dose Limiting Toxicity Was Identified|Each cycle where the patient receives eribulin and does not receive non-protocol anticancer therapy will be considered in the analysis. A dose limiting toxicity is defined to be: day 8 eribulin dose is held due to grade 3 or grade 4 non-hematological toxicity attributable to the investigational drug and does not resolve to meet eligibility or baseline criteria by day 11. Any >= grade 3 non-hematological toxicity attributable to the investigational drug with the specific exclusion of: grade 3 nausea and vomiting < 3 days duration grade 3 liver enzyme elevation, including alanine aminotransferase (ALT)/aspartate aminotransferase (AST)/gamma-glutamyltransferase (GGT), that returns to grade =< 1 or baseline prior to the time for the next treatment cycle.|4 months|19 patients were treated on protocol therapy. Thirty-nine cycles were reported for the analysis of dose limiting toxicity.|||Cycles|Cycles||Number
2606724|NCT02097238|Primary|Response Evaluation Criteria in Solid Tumors (RECIST) Response|The number of patients who experience a complete or partial response according to the RECIST criteria as defined in Eisenhauer et al. Eur J Cancer 45:228-47, 2009.|4 months||||participants|||Number
2606725|NCT02097238|Primary|Disease Control Success|The number of patients who do not experience disease progression or death in the four months following enrollment on AOST1322.|4 Months||||participants|||Number
2606726|NCT02097134|Secondary|Vision Acuity, Assessed According to the Amblyopia Treatment Study Visual Acuity Testing Protocol|Estimated by the average visual acuity amongst patients evaluated with a 95% confidence interval.|1 year after therapy|"The study was terminated at stage I since the therapy was considered not feasible to deliver.~No patients had this data available. Patients either had affected eye enucleated, or did not complete protocol therapy."||||||
2606727|NCT02097134|Secondary|Rate of Metastases of Retinoblastoma|The percentage of patients who experience metastases of retinoblastoma will be estimated. Ineligible patients or patients who do not receive any protocol therapy are excluded from this analysis|Up to 2 years|One patient who did not receive protocol therapy was excluded.|||Percentage of Patients|||Number
2606728|NCT02097134|Secondary|Probability of Ocular Salvage|A patient will be considered an ocular-salvage success if enucleation because of disease progression or toxicity is not required during the 2 years following enrollment.|2 years|One patient who did not receive protocol therapy was excluded. Two patients who were lost to follow-up or follow-up was terminated electively prior to 2 years by patient or parent preference were excluded.|||Percentage of patients||95% Confidence Interval|Number
2606729|NCT02097134|Secondary|Incidence of Grade 3 or Higher CTCAE Adverse Events Associated With Multiple Doses of IA Chemotherapy|The percentage of patients with at least 1 occurrence of grade 3 or higher CTCAE adverse experience will be provided. Ineligible patients or patients who do not receive any protocol therapy are excluded from reporting of adverse events.|Up to 30 days after completion of study treatment|One patient who did not receive protocol therapy was excluded.|||Percentage of patients||95% Confidence Interval|Number
2606730|NCT02097134|Primary|Number of Patients Experiencing Feasibility Failure|Feasibility failure is defined as a) interventional radiologist is unable to access the ophthalmic artery for the 1st chemotherapy administration for any reason; b) patient develops central retinal artery occlusion after the 1st or 2nd course that does not reopen by the time the next injection is due; or c) the patient cannot receive all three treatments because of Common Terminology Criteria for Adverse Events (CTCAE) complications grade III or IV that are considered possibly, probably or likely related treatment.|Up to 4 months|All Patients who are eligible and evaluable for the feasibility outcome are included in this outcome|||participants|||Number
2606731|NCT02097108|Secondary|High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks||baseline to week 24||||mg/dl||Standard Deviation|Mean
2606732|NCT02097108|Secondary|Triglycerides Baseline and After 24 Weeks||baseline to week 24||||mg/dl||Standard Deviation|Mean
2606734|NCT02097108|Primary|Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction|A reduction of > 5% in the plasma concentration of direct LDL cholesterol from baseline to week 12 or > 10% reduction of total cholesterol or reduction of lipid lowering agents is expected. Reduction of lipid lowering agents is defined as reduction due to amelioration of lipid profiles and does not include reduction due to side effects or other toxicity issues.|baseline to week 12|all patients|||percentage of participants||95% Confidence Interval|Number
2606735|NCT02097056|Secondary|Change From Baseline in the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Distress Total Scores|"The NPI-Q assessed twelve behavioral domains common in dementia including; hallucinations, delusions, agitation/aggression, dysphoria/depression, anxiety, irritability, disinhibition, euphoria, apathy, aberrant motor behavior, sleep/night-time behavior change, and appetite/eating change. The questionnaire is given by the clinician to the patient's caregiver who was asked if the behavior described is present in the patient. If Yes, the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale (1 = mild, 2= moderate, and 3= severe) and the associated impact of the symptom manifestations on them (i.e. Caregiver Distress) using a 5-point scale (0 = not distressing at all, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = extreme or very severe). The total severity score represents the sum of individual scores and ranges from 0 to 36. The total distress score represents the sum of individual symptom scores and ranges from 0 to 60."|Baseline, Week 12, and Week 24 (Follow up visit)|Efficacy analysis population included all participants who took at least one dose of study drug and had at least one baseline and at least one post-baseline assessment of the efficacy parameter. Twenty participants had no efficacy variables collected.|||Scores on a scale||Standard Deviation|Mean
2606736|NCT02097056|Secondary|Change From Baseline in the Mini-Mental State Examination (MMSE) Score|The MMSE was used to measure cognitive impairment. The MMSE can evaluate overall cognitive function, and is widely used for the assessment of cognitive impairment in dementia patients. The questionnaire consists of 11 items, and each item aims to evaluate different cognitive domains such as orientation, memory, attention, and construction. The score ranged from 0 to 30, with a higher score indicating better function. A positive change score indicated improvement from baseline. The mean change was analyzed by Wilcoxon's signed rank test.|Baseline, Week 12, and Week 24 (Final visit)|Efficacy analysis population included all participants who took at least one dose of study drug and had at least one baseline and at least one post-baseline assessment of the efficacy parameter. Twenty participants had no efficacy variables collected.|||Scores on a scale||Standard Deviation|Mean
2606737|NCT02097056|Primary|Overall Summary of Adverse Events (AEs)|Safety of study drug was assessed by clinical laboratory assessments, vital signs, weight, 12-lead electrocardiogram (ECG), physical and neurological examination. Treatment-Emergent Adverse Events (TEAEs) were defined as any event not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Serious adverse events were defined as AEs that led to or were life-threatening, resulted in or prolonged hospitalization, caused important or long-lasting disability, caused congenital abnormality or malformation, or resulted in death. Adverse drug reactions were defined as any harmful or unintended reaction to study treatment and were considered possibly related or probably related to study drug. Specific AEs and SAEs due to changes in clinical laboratory assessments, vital signs, weight, ECG, and physical and neurological exam are listed in the safety section.|Baseline (Day 1) up to Week 24|Safety population included all participants who received at least one dose of study treatment and had at least one postbaseline safety assessment.|||Percentage of participants|||Number
2606738|NCT02097030|Secondary|Ocular Health - Biomicroscopy|The investigator's objective assessment of ocular health assessed for each study Pair after 3 days wear by biomicroscopy. Bulbar and Limbal Hyperemia; Corneal Staining Type, Extent and Depth, Conjunctival Staining and Indentation. BrienHolden Vision Institute Continuous Scale: 1-4, 0.5 steps (1=Very, 2=Slight, 3=Moderate, 4=Severe)|3 Days Follow-up|Only right eye data shown. Left eye data virtually identical. One subject had non-contact lens related adverse event in the nelfilcon A group. Subject temporarily discontinued and went on to complete the study.|||units on a scale||Standard Deviation|Mean
2606739|NCT02097030|Secondary|Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)|The investigator's objective assessment for contact lens fit and performance - tightness. Measured at baseline (10-15mins settling) for both study pairs. Tightness (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).|Baseline and 3 day follow-up||||units on a scale||Standard Deviation|Mean
2606740|NCT02097030|Secondary|Lens Fit and Performance - Fit Acceptance|The investigator's objective assessment for contact lens fit and performance - fit acceptance. Measured at baseline and 3 day follow-up (10-15mins settling) for both study pairs. Fit acceptance (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).|Baseline and 3 day follow-up||||units on a scale||Standard Deviation|Mean
2606741|NCT02097030|Secondary|Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up)|The investigator's objective assessment for contact lens fit and performance - movement. Measured at baseline (10-15mins settling) for both study pairs. Movement (scale in millimeters).|Baseline and 3 days follow-up||||units on a scale||Standard Deviation|Mean
2606742|NCT02097030|Secondary|Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up)|The investigator's objective assessment for contact lens fit and performance - debris. Measured at baseline (10-15mins settling) for both study pairs. (Debris scale 0-4; 0.25 steps; 0=no debris, 4=significant debris)|Baseline and 3 day follow-up||||units on a scale||Standard Deviation|Mean
2606743|NCT02097030|Secondary|Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)|The investigator's objective assessment for contact lens fit and performance - deposits. Measured at baseline (10-15mins settling) for both study pairs. Deposits (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced);|Baseline and 3 days follow-up||||units on a scale||Standard Deviation|Mean
2606744|NCT02097030|Secondary|Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)|The investigator's objective assessment for contact lens fit and performance - wettability. Measured at baseline (10-15mins settling) for both study pairs. Wettability (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced).|Baseline and 3 days follow-up||||units on a scale||Standard Deviation|Mean
2606790|NCT02096705|Primary|Adjusted Mean Change in HbA1c From Baseline to Week 24|The adjusted mean change in the percentage of Hemoglobin A1c (HbA1c) from baseline to Week 24 was reported for each arm.|Baseline (Day 1) and 24 weeks|All randomized participants with non-missing baseline and at least one post-baseline value|||percentage of hemoglobin||Standard Error|Mean
2606746|NCT02097030|Secondary|Overall Satisfaction, Dryness|Participant's subjective response for overall dryness satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||participants|||Number
2606747|NCT02097030|Secondary|Overall Satisfaction, Handling|Participant's subjective response for overall handling satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||participants|||Number
2606748|NCT02097030|Secondary|Overall Satisfaction, Comfort|Participant's subjective response for overall comfort satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||participants|||Number
2606749|NCT02097030|Secondary|Overall Satisfaction, Vision|Participant's subjective response for overall vision satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||participants|||Number
2606750|NCT02097030|Secondary|Subjective Response for Dryness|Participant's subjective response for dryness, measured at baseline and after 3 day follow-up of daily disposable wear of lenses. (Dryness Scale 0-100, 0=Cannot be worn/extremely dry, 100=no dryness experienced at any time).|3 Days Follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||units on a scale||Standard Deviation|Mean
2606751|NCT02097030|Secondary|Subjective Response for Handling (Insertion and Removal)|Participant's subjective response for handling (insertion and removal) measured at 3 day follow-up of daily disposable wear of lenses. (Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).|3 days follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||units on a scale||Standard Deviation|Mean
2606752|NCT02097030|Secondary|Subjective Response for Insertion|Participant's subjective response for insertion measured at baseline. (Insertion Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).|Baseline|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||units on a scale||Standard Deviation|Mean
2606753|NCT02097030|Secondary|Subjective Response for Vision|Participant's subjective response for vision measured at baseline and at 3 day follow-up of daily disposable wear of lenses. (Vision Scale 0-100, 0=very blurry, 100=very clear).|Baseline and 3 day follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||units on a scale||Standard Deviation|Mean
2606754|NCT02097030|Secondary|Subjective Response for Comfort|Participant's subjective response for comfort measured at baseline and 3 day follow-up. (Continuous Comfort Scale 0-100, 0=cannot be worn/causes pain, 100=cannot be felt ever)|Baseline and 3 day follow-up|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||units on a scale||Standard Deviation|Mean
2606755|NCT02097030|Primary|Overall Lens Preference - Hydrogel vs. Filcon II 3|Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).|Study Exit|30 subjects|||participants|||Number
2606756|NCT02097030|Primary|Overall Lens Preference - All Study Lenses|Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair of lenses. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).|Study Exit|Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.|||participants|||Number
2606757|NCT02096952|Primary|Change in Adult ADHD Investigator Symptom Report Scale (AISRS) Score|"The Adult ADHD Investigator Symptom Report Scale (AISRS) assesses each of the 18 individual symptoms of ADHD in DSM-IV on a Likert scale from 0 (not present) to 3 (severe), with a total possible score of 54.~The change in AISRS score from baseline to endpoint (6 weeks) was calculated as the later time point score minus the earlier time point score."|Baseline to 6 weeks||||units on a scale||Standard Deviation|Mean
2606758|NCT02096900|Post-Hoc|Modified Yale Preoperative Anxiety Scale (mYPAS) Score at Separation (mYPAS2) Based on Baseline (mYPAS1) Score.|"Midazolam group participants will be separated into two groups; non-anxious (mYPAS1 ≤ 30) at baseline and anxious (mYPAS1 > 30) at baseline. The mYAPS2 scores of these two groups will be compared to the mYPAS2 scores of the Zolpidem group participants.~The modified Yale Preoperative Anxiety scale (m-YPAS) is a structured observational measure of preoperative anxiety in children that takes less than a minute to preform. It consists of assessment of 27 items in 5 domains of behavior indicating anxiety in young children; activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each item is weighted in calculation of the total score that ranges from 22.5 -100. A cut off 30 on the m-YPAS scale was found to balance the high specificity and sensitivity while maintaining high positive predictive value. Children with a score above 30 are considered anxious while those with the score of 30 or less were considered not anxious."|Up to 24 hours including pre-operative, peri-operative and post-operative periods.||||units on a scale||Inter-Quartile Range|Median
2606775|NCT02096744|Secondary|Cmax (Maximum Concentration of Clonidine in Plasma)|Cmax (maximum concentration of clonidine in plasma) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration|PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2606759|NCT02096900|Secondary|Parental/Caregiver Anxiety Assessed Using the Validated State-Trait Anxiety Inventory for Adults (STAI)|"Parental/caregiver anxiety, was assessed using the validated State-Trait Anxiety Inventory for Adults (STAI), a validated self-evaluation questionnaire.~The STAI is compromised of separate self-report scales for measuring state and trait anxiety. The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that evaluate how respondents feel right now, at this moment. The T-Anxiety scale (STAI Form Y-2) consists of twenty statements that assess how respondents generally feel. The score ranges from 20 (most relaxed) to 80 (highest stress).~The baseline STAI inventory was completed by e parent/caregiver after obtaining the informed consent in the preoperative holding area and before the subject was separated from the caregiver. Baseline STAI inventory consisted of form STAIY-1 (State Anxiety) and form STAIY-2 (Trait Anxiety) anxiety.~After caregiver/patient separation,form STAIY-1(State Anxiety) was completed again by the caregiver."|Preoperative holding area from the time of informed consent until caregiver/patient separation.|only total of 51 subjects were analyzed. Caregivers of 29 subjects were given incorrect form to fill at time of separation rendering data not applicable for analysis for the 29 subjects.|||units on a scale||Standard Deviation|Mean
2606760|NCT02096900|Secondary|Presence of Emergence Delirium During Recovery|Presence or absence of emergence delirium during recovery, will be assessed using the pediatric anesthesia emergence delirium (PAED) scale recorded at 5-minute intervals for 20 minutes following the child's spontaneous eye opening. PAED score of ≥12 at any time indicates presence of emergence delirium.|Up to 30 minutes after child's first eye opening in the post-operative period.||||Participants|||Count of Participants
2606761|NCT02096900|Secondary|Mask Acceptance Score|"Mask acceptance by the patient, will be measured on a 4-point scale adapted from a similar trial.~Score of 1 and 2 indicates satisfactory mask acceptance. Score of 3 or 4 indicates unsatisfactory mask acceptance during induction of general anesthesia."|During induction of general anesthesia.||||Participants|||Count of Participants
2606762|NCT02096900|Primary|Patient Anxiety at the Time of Separation|"The primary outcome measure of patient anxiety will be measured using the validated Modified Yale Preoperative Anxiety Score (mYPAS). The mYPAS is the current standard for evaluation of anxiety in children receiving anesthesia for surgical procedures.~The modified Yale Preoperative Anxiety scale (m-YPAS) is a structured observational measure of preoperative anxiety in children. It was developed by the study group lead by Kain Z. It consists of assessment of 27 items in 5 domains of behavior indicating anxiety in young children; activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each item is weighted in calculation of the total score that ranges from 22.5 -100. Children with a score above 30 are considered anxious while those with the score of 30 or less were considered not anxious."|Up to 24 hours including preoperative, preoperative, and postoperative periods.||||units on a scale||Inter-Quartile Range|Median
2606763|NCT02096861|Secondary|The Short Inflammatory Bowel Disease Questionnaire|"SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70.~Higher values of SIBDQ represent a better patient disease outcome."|Baseline and Week 54|Number Analyzed at each visit is the number of patients who had SIBDQ score at each visit.|||scores on a scale||Standard Deviation|Mean
2606764|NCT02096861|Secondary|The Short Inflammatory Bowel Disease Questionnaire (SIBDQ)|"SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70.~Higher values of SIBDQ represent a better patient disease outcome."|Up to Week 30|"Number Analyzed at each visit is the number of patients who had SIBDQ score at each visit.~CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group"|||scores on a scale||Standard Deviation|Mean
2606765|NCT02096861|Secondary|The Number and Percentage of Patients Achieving Clinical Remission at Week 54|Clinical remission was defined as an absolute CDAI score of less than 150 points.|Week 54||||Participants|||Count of Participants
2606766|NCT02096861|Secondary|The Number and Percentage of Patients Achieving Clinical Remission at Week 30|Clinical remission was defined as an absolute CDAI score of less than 150 points.|Week 30|CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group|||Participants|||Count of Participants
2606767|NCT02096861|Secondary|The Number and Percentage of Patients Achieving Clinical Remission at Week 6|Clinical remission was defined as an absolute CDAI score of less than 150 points.|Week 6|CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group|||Participants|||Count of Participants
2606768|NCT02096861|Secondary|The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54|A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value.|Week 54||||Participants|||Count of Participants
2606769|NCT02096861|Secondary|The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30|A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value.|Week 30|CT-P13 group including CT-P13-CT-P13 and CT-P13-Remicade treatment group Remicade group including Remicade-Remicade and Remicade-CT-P13 treatment group|||Participants|||Count of Participants
2606770|NCT02096861|Primary|The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6|A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more at Week 6 comparing to the baseline value.|at Week 6|"CT-P13 treatment group including CT-P13 - CT-P13 and CT-P13 - Remicade treatment groups.~Remicade treatment group including Remicade - Remicade and Remicade - CT-P13 treatment groups."|||Participants|||Count of Participants
2606771|NCT02096835|Other Pre-specified|Need of Postoperative Metoclopramide|the number of patients who needed metoclopramide as a rescue medicine postoperatively|within 48h after operation||||participants|||Number
2606772|NCT02096835|Secondary|Number of Participants Experiencing Postoperative Vomiting in 24h Postoperatively|including retching and vomiting|within 24h after operation||||participants|||Number
2606773|NCT02096835|Secondary|Number of Participants Experiencing Postoperative Nausea in 24h Postoperatively||within 24h after the operation||||participants|||Number
2606774|NCT02096835|Primary|Number of Participants Experiencing Postoperative Nausea and Vomiting in 24h Postoperatively|the total number including nausea, retching and vomiting within 24h after operation|within 24h after operation||||participants|||Number
2606776|NCT02096744|Secondary|AUC0-inf(Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to Infinity)|AUC 0-inf(area under the concentration-time curve of clonidine in plasma over the time interval from 0 to infinity) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration|PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2606777|NCT02096744|Primary|Cavg (Average of Measured Concentrations of Clonidine in Plasma on Days 5, 6, and 7)|Cavg (average of measured concentrations of clonidine in plasma on Days 5, 6, and 7) The values for geometric mean and gCV are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 192h, 216h, 240h after patch administration|PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2606778|NCT02096744|Primary|AUC0-168 (Area Under the Concentration-time Curve of Clonidine in Plasma Over the Time Interval From 0 to 168 h)|AUC0-168 (area under the concentration-time curve of clonidine in plasma over the time interval from 0 to 168 h) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before patch administration and 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h after patch administration|PKS included all treated subjects who provided at least one observation for at least one primary endpoint without protocol violations with respect to the statistical evaluation of PK endpoints.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2606779|NCT02096731|Primary|Community Acquired Pneumonia|"The community acquired pneumonia rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.~Pt. = Patient"|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium), who can be linked to the Hospital Episode Statistics database, and were matched via propensity score.|||No.of incident Pneumonia/1000 pt./year|||Number
2606780|NCT02096731|Primary|Cardiac Arrhythmia|The cardiac arrhythmia (CA) rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium), who can be linked to the Hospital Episode Statistics database, and were matched via propensity score.|||No. of incident CA/1000patients /year|||Number
2606781|NCT02096731|Primary|Heart Failure|The heart failure (HF) rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium) and were matched via propensity score.|||No. of incident HF/1000patients/year|||Number
2606782|NCT02096731|Primary|Stroke|The stroke rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium) and were matched via propensity score.|||No. of incident stroke/1000patients/year|||Number
2606783|NCT02096731|Primary|Myocardial Infarction|"The acute myocardial infarction (MI) rate per 1000 patients per year after matching on high-dimensional propensity score and inhaled corticosteroid (ICS) use in the year prior to cohort entry.~No. = Number"|Up to 12 months|The subset of patients from the base cohort who were either on monotherapy (who stayed on monotherapy) or combination therapy (who added tiotropium to LABA or added LABA to tiotropium) and were matched via propensity score.|||No. of incident MI/1000patients/ year|||Number
2606784|NCT02096718|Secondary|AUC 0-inf of Afatinib (BIBW 2992)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity|PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration|The pharmacokinetic set (PKS): included all patients in the treated set who provided evaluable data for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2606785|NCT02096718|Primary|Cmax of Afatinib (BIBW 2992)|Maximum measured concentration of the analyte in plasma|PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration|The pharmacokinetic set (PKS): included all patients in the treated set who provided evaluable data for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2606786|NCT02096718|Primary|AUC 0-tz of Afatinib (BIBW 2992)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point|PK plasma samples were taken at: 1 hour before drug administration and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 312h after first drug administration|The pharmacokinetic set (PKS): included all patients in the treated set who provided evaluable data for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2606787|NCT02096705|Secondary|Adjusted Mean Change in Absolute Calculated Mean Total Daily Dose of Insulin (TDDI) From Baseline to Week 24|The adjusted mean change in absolute calculated mean Total Daily Dose of Insulin (TDDI) from baseline to week 24 was reported for each arm in International Units (IU).|Baseline (Day 1) and 24 weeks|All randomized participants with non-missing baseline and at least one post-baseline value|||International Units (IU)||Standard Error|Mean
2606791|NCT02096692|Primary|Percentage of Participants Free of R-wave Sensing Attenuation|Evaluate the percentage of subjects free of R-wave attenuation between the Pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|All participants who had measurable R-waves at both pre-MRI and and 1 Month Post-MRI.|||percentage of participants||95% Confidence Interval|Number
2606792|NCT02096692|Primary|Percentage of Participants Free of Ventricular Pacing Threshold Rise|Evaluate the percentage of ICD leads free of ventricular pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI||||percentage of participants||95% Confidence Interval|Number
2606793|NCT02096692|Primary|MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate||1 Month Post-MRI||||percentage of participants||95% Confidence Interval|Number
2606794|NCT02096679|Secondary|Pharmacokinetics of AZD9291 and Urine [14C] Total Radioactivity by Assessment of Percentage (or Fraction) of Actually Administered Dose / Radioactivity (Feu)|Pharmacokinetics of AZD9291 and urine [14C] total radioactivity by assessment of percentage (or fraction) of actually administered dose / radioactivity (feu), derived from the curve taken during the treatment period.|Urine (h): 0-4, 4-8, 8-12, 12-24, every 24 hrs to 504, 648-72, 816-40, 984-1008 and 1992-2016.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||Percentage of administered dose||Standard Deviation|Mean
2606795|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Urine [14C] Total Radioactivity by Assessment of Urine Concentration or Concentration Equivalent x Urine Volume (Aeu)|Pharmacokinetics of AZD9291, its metabolites and urine [14C] total radioactivity by assessment of urine concentration or concentration equivalent x urine volume (Aeu), derived from the curve taken during the treatment period.|Urine (h): 0-4, 4-8, 8-12, 12-24, every 24 hrs to 504, 648-72, 816-40, 984-1008 and 1992-2016.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nmol||Standard Deviation|Mean
2606796|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Area Under the Concentration-time Curve AUC|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of area under the concentration-time curve AUC, derived from the curve taken during the treatment period.|Blood samples (hrs) - 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM*h||Full Range|Geometric Mean
2606797|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of AUC Ratio of WBR to PR (AUC(WBR)/AUC(PR))|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of AUC ratio of WBR to PR (AUC(WBR)/AUC(PR)), derived from the curves taken during the treatment period.|Blood samples (hrs) - 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||ratio||Full Range|Geometric Mean
2606798|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of AUC Ratio of Plasma AZD9291, AZD7550 or AZD5104 (PL) to Plasma Radioactivity (PR) AUC(PL)/AUC(PR)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of AUC ratio of plasma AZD9291, AZD7550 or AZD5104 (PL) to plasma radioactivity (PR) AUC(PL)/AUC(PR), derived from the curves taken during the treatment period.|Blood samples (hrs) - 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||ratio||Full Range|Geometric Mean
2606799|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Cmax Ratio of Whole Blood Radioactivity (WBR) to PR Cmax (WBR)/Cmax(PR)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of Cmax ratio of whole blood radioactivity (WBR) to PR Cmax (WBR)/Cmax(PR), derived from the curves taken during the treatment period.|Blood samples (hrs) - 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||ratio||Full Range|Geometric Mean
2606800|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Cmax Ratio of Plasma AZD9291, AZ7550 or AZ5104 (PL) to Plasma Radioactivity (Cmax(PL)/Cmax(PR))|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of Cmax ratio of plasma AZD9291, AZ7550 or AZ5104 (PL) to plasma radioactivity (Cmax(PL)/Cmax(PR)), derived from the curves taken during the treatment period.|Blood samples (hrs) - 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||ratio||Full Range|Geometric Mean
2606801|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Cmax Metabolite to Parent Ratio, AZ7550 or AZ5104 (M/PCmax)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of Cmax metabolite to parent ratio, AZ7550 or AZ5104 (M/PCmax), derived from the curves taken during the treatment period.|Blood samples (hrs) - 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||ratio||Full Range|Geometric Mean
2606802|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of AUC Metabolite to Parent Ratio, AZ7550 or AZ5104 AUC/AZD9291 AUC Adjusted for Differences in Molecular Weight (M/PAUC)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of AUC metabolite to parent ratio, AZ7550 or AZ5104 AUC/AZD9291 AUC adjusted for differences in molecular weight (M/PAUC), derived from the curves taken during the treatment period.|Blood samples (hrs) - 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||Ratio||Full Range|Geometric Mean
2606803|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Elimination Rate Constant (λz)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of elimination rate constant (λz), derived from the curve taken during the treatment period.|Blood samples (hrs) - 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||1/h||Full Range|Geometric Mean
2606804|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Elimination Half-life (t1/2,λz)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of elimination half-life (t1/2,λz), derived from the curve taken during the treatment period.|Blood samples (hrs) - 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||hour||Full Range|Mean
2606805|NCT02096679|Secondary|Pharmacokinetics of AZD9291 Plasma, Whole Blood and Plasma [14C] Radioactivity by Assessment of Apparent Volume of Distribution (Vz/F)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of apparent volume of distribution (Vz/F), derived from the curve taken during the treatment period.|Blood samples (hrs) - 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||L||Full Range|Mean
2606806|NCT02096679|Secondary|Pharmacokinetics of AZD9291 Plasma, Whole Blood and Plasma [14C] Radioactivity by Assessment of Apparent Oral Clearance (CL/F)|Pharmacokinetics of AZD9291 plasma, whole blood and plasma [14C] radioactivity by assessment of apparent oral clearance (CL/F), derived from the curve taken during the treatment period.|Blood samples (hrs) - 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||L/h||Full Range|Mean
2606807|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Lag Time Before Observation of Quantifiable Analyte Concentrations (Tlag)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of lag time before observation of quantifiable analyte concentrations (tlag), derived from the curve taken during the treatment period.|Blood samples (hrs) - 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||hours||Inter-Quartile Range|Median
2606808|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Time to Cmax (Tmax)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of by assessment of time to Cmax (tmax), derived from the curve taken during the treatment period.|Blood samples (hrs) - 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||hours||Inter-Quartile Range|Median
2606809|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Maximum Plasma Concentration (Cmax)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of maximum plasma concentration (Cmax), derived from the curve taken during the treatment period.|Blood samples (hrs) - 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM||Full Range|Geometric Mean
2606810|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Area Under the Concentration-time Curve From Time Zero to 24 Hours AUC(0-24)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of area under the concentration-time curve from time zero to the time of 24 hours AUC(0-24), derived from the curve taken during the treatment period.|Blood samples (hrs) - 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM*h||Full Range|Geometric Mean
2606904|NCT02095951|Secondary|Re-infection|Number of Re-Infected of salvaged catheters with same or new organism(s) within 28 days of prior CRI/ELT|Participants will be followed for the duration of hospital stay, an expected average of 2 weeks but for up to 1 month total|1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group.|||Catheters|Catheters||Number
2606811|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Area Under the Concentration-time Curve From Time Zero to the Time of 72 Hours AUC(0-72)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of area under the concentration-time curve from time zero to the time of 72 hours AUC(0-72), derived from the curve taken during the treatment period.|Blood samples (hrs) - 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM*h||Full Range|Geometric Mean
2606812|NCT02096679|Secondary|Pharmacokinetics of AZD9291, Its Metabolites and Whole Blood and Plasma [14C] Radioactivity by Assessment of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration AUC(0-t)|Pharmacokinetics of AZD9291, its metabolites and whole blood and plasma [14C] radioactivity by assessment of area under the concentration-time curve from time zero to the time of the last quantifiable concentration AUC(0-t), derived from the curve taken during the treatment period.|Blood samples (hrs) - 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||nM*h||Full Range|Geometric Mean
2606813|NCT02096679|Primary|Percentage of Radioactive Dose of [14C] Radiolabelled AZD9291 Recovered in Urine, Faeces, and in Total.|The percentage of radioactive dose of [14C] radiolabelled AZD9291 recovered in urine, faeces, and in total, up to Day 85.|Blood samples (hrs) - 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, every 24 to 168, 336, 504, 648, 816, 904 and 1992. Urine (h): 0-4, 4-8, 8-12, 12-24, every 24 hrs to 504, 648-72, 816-40, 984-1008 and 1992-2016. Faeces: 0-24h and then as per urine.|Pharmacokinetic population - all subjects who received 1 dose of [14C]-AZD9291 and had at least 1 postdose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of the investigational product|||Percentage radioactive dose recovered||Standard Deviation|Mean
2606814|NCT02096588|Secondary|Recurrence Free Survival (RFS) With Concurrent Simvastatin|To describe the recurrence free survival (RFS) in early stage breast cancer patients treated with anthracycline-based chemotherapy with and without concurrent simvastatin|5 years||2023-03-31|03/2023||||
2606815|NCT02096588|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Number of participants with concurrent administration of simvastatin with (neo)adjuvant anthracycline-based chemotherapy in early stage breast cancer patients who experience adverse events as defined by NCI CTCAE v4.0.|52 weeks|"Adverse event data was not collected from the No drug arm."|||Participants|||Count of Participants
2606816|NCT02096588|Primary|Change in Echocardiographic Global Longitudinal Strain (GLS)|To compare the absolute change in echocardiographic GLS (Global Longitudinal Strain) from baseline (T0) to 2-3 weeks after (T2) completion of 4 cycles of (neo)adjuvant anthracycline-based chemotherapy in early stage breast cancer patients who do and do not receive concurrent simvastatin therapy|up to 15 weeks|Only participants with GLS measured on both T0 and T2 echocardiograms were evaluable for this outcome measure. Therefore, data was evaluable in only 27/31 participants for this outcome measure.|||Percentage change in GLS||Standard Deviation|Mean
2606817|NCT02096575|Secondary|Visual Analog Scale to Measure Anticipated Pain.|Anticipated pain is assessed before the procedure. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain|Anticipated pain assessed on average within 30 minutes before procedure||||units on a scale||Standard Deviation|Mean
2606818|NCT02096575|Secondary|Pain Management Satisfaction|Quantitative assessment of pain management. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain|Visual analog scale for satisfaction administered on average within 20 minutes after procedure completion.||||units on a scale||Standard Deviation|Mean
2606819|NCT02096575|Secondary|Visual Analog Scale for Post-procedure Pain|A quantitative assessment of post-procedure pain. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain|Visual analog scale administered on average 20 minutes after procedure completed||||units on a scale||Standard Deviation|Mean
2606820|NCT02096575|Secondary|Visual Analog Scale Score for Baseline Pain|A quantitative assessment of pain prior to the procedure. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain|Baseline pain assessment on average within 30 minutes before procedure||||units on a scale||Standard Deviation|Mean
2606821|NCT02096575|Primary|Visual Analog Pain Score for Mean Maximum Procedural Pain|"The primary outcome of this study is to evaluate the difference in mean maximum pain experienced during the procedure between groups as assessed 5 minutes after the procedure is completed.~Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain"|Mean maximum pain experienced during the procedure and assessed 5 minutes after the procedure||||units on a scale||Full Range|Mean
2606822|NCT02096471|Secondary|Mean Half-Life for the PD-0325901 Concentrations|Half life Estimates of PD-0325901 of the Parent and Metabolite Compound, based on samples at Pre-dose, .5 Hr. Post dose, 1.0 Hr.Post dose, 2.0 Hr.Post dose, 3.0 Hr. Post dose, 4.0 Hr.Post dose, 6.0 Hr. Post dose, 8.0 Hr. Post dose, 10.0-12.0 Hr. Post dose.|Day 1; Course 1|18 of the 19 participants had PK samples collected and the metabolite compound AUC was computed and summarized.|||hours||Standard Deviation|Mean
2606823|NCT02096471|Secondary|Area Under the Curve for the Metabolite Compound|Mean 12-Hour AUC Estimates of the Parent and Metabolite Compound, based on samples at Pre-dose, .5 Hr. Post dose, 1.0 Hr.Post dose, 2.0 Hr.Post dose, 3.0 Hr. Post dose, 4.0 Hr.Post dose, 6.0 Hr. Post dose, 8.0 Hr. Post dose, 10.0-12.0 Hr. Post dose.|Day 1; Course 1|18 of the 19 participants had PK samples collected and the metabolite compound AUC was computed and summarized.|||ng/mL*hr/(mg/m^2 Metabolite)||Standard Deviation|Mean
2606844|NCT02096263|Secondary|Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN.|Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.|At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||IU/mL||95% Confidence Interval|Geometric Mean
2606824|NCT02096471|Secondary|Quality of Life Using the Pain Subscale of the NRS-11 and PedsQL™ NF1 for Subjects Receiving PD-0325901 Using Age-based Assessments|"The PedsQL™ NF1 Module asks how much of a problem each item has been during the past one month. A 5-point response scale: 0= never a problem...4= almost always a problem). Items are reverse scored and linearly transformed to a scale of 0-100 Higher scores = better HRQOL. The total scale score is the sum of items divided by the number answered. Subscale scores are computed similarly. If more than 50% of the items in the scale are missing, the scale score is not computed. The Numerical Rating Scale-11 (NRS-11) is a self-report segmented 11-point numeric scale that assesses pain intensity with 0 representing no pain at the right end of the line and 10 representing worst pain you can imagine. The Brief Pain Inventory (BPI)—Pain Interference Scale is a 7-item self-report questionnaire asking (general activity, mood, walking, normal work, relations with other people, sleep, and enjoyment of life) in the past week with 0 = no interference and 10 = completely interferes."|Baseline to 12 Months|NRS-11 are on a scale of 0-10 with 0 being no pain, higher scores are greater intensity. BPI pain interference scale yields a total score (each item 0–10 and total score=mean all items) higher scores are more pain interference.Remaining items are initially a 5-point Likert scale (0-4) and transformed to a 0-100 scale with higher scores better QOL.|||score on a scale||Standard Error|Least Squares Mean
2606825|NCT02096471|Secondary|Area Under the Curve for the Parent Compound|Mean and Standard Deviation AUC Estimates of the levels of PD-0325901 over 12-Hours for both the Parent and Metabolite Compound, based on samples at Pre-dose, .5 Hr. Post dose, 1.0 Hr.Post dose, 2.0 Hr.Post dose, 3.0 Hr. Post dose, 4.0 Hr.Post dose, 6.0 Hr. Post dose, 8.0 Hr. Post dose, 10.0-12.0 Hr. Post dose.|Day 1; Course 1|18 of the 19 participants had PK samples drawn.|||ng/mL*hr/(mg/m^2Parent)||Standard Deviation|Mean
2606826|NCT02096471|Secondary|The Objective Response Rate of up to 2 Non-Target Plexiform Neurofibromas to PD-0325901|radiographic response based on volumetric MRI measurements of up to 2 Non Target Plexiform Neurofibromas classified as complete, partial, stable or progressive|Baseline to 24 Months|All participants were evaluated and the two with non-Plexiform Neurofibromas were assessed.|||participants|||Number
2606827|NCT02096471|Secondary|Toxicity of PD-0325901|Number and Percent of Participants with AEs and SAEs|Baseline to 24 Months||||participants|||Number
2606828|NCT02096471|Secondary|Evaluable Participants Treated With PD-0325901|"Number of Evaluable Patients at 24 Months:~Any subject with ≥ one dose of PD-0325901 and had a ≥ Grade 3 associated toxicity is evaluable for toxicity.~In the absence of a ≥ Grade 3 toxicity, any subject who completed one full course of therapy is evaluable for toxicity.~Evaluable For Response - Subjects who have completed at least two courses of therapy and have had their first follow-up MRI evaluation. Subjects who did not respond and are later found to have a target tumor other than a plexiform neurofibroma (e.g. malignant peripheral nerve sheath tumor) are not evaluable for response.~Evaluable for Pharmacokinetics - Any subject who has at least 4 samples drawn for pharmacokinetics is evaluable for pharmacokinetics.~Evaluable for Pharmacodynamics - Any subject who has a dermal neurofibroma biopsy for pharmacodynamics prior to starting therapy plus at least one other dermal neurofibroma biopsy is evaluable for"|baseline to 24 months|ITT|||Participants|||Count of Participants
2606829|NCT02096471|Primary|Percent of Participants With a 20% or More Change in Target Tumor Volume|"Response is assessed by the NCI-POB at the time that follow-up 3D-MRI scans are performed (after course 4, 8, 12, and then after completion of every 6 courses thereafter). For the purpose of determining the level of response (complete, partial, etc.) measurements from the follow-up scans are compared to the target lesion size in the pretreatment MRI scan using 3D data analysis.Complete Response (CR): A complete resolution of the target plexiform neurofibroma for ≥ 4 weeks Partial Response (PR): A ≥20% reduction in the volume of the target plexiform neurofibroma lesion for ≥4 weeks. Stable Disease (SD): A <20% increase, and < 20% decrease in the volume of the target plexiform neurofibroma lesion for ≥4 weeks.~Progressive Disease (PD): A ≥ 20% increase in the volume (by 3D-MRI) of the target plexiform neurofibroma compared to the pretreatment volume.."|baseline to 24 months|All 19 participants enrolled equivalent to intention to treat population|||Participants|||Count of Participants
2606830|NCT02096458|Primary|Time to In-Vivo Disintegration of Dexlansoprazole 30 mg Orally Disintegrating Tablets|The disintegration time is the total time from when the participant places the tablet on their tongue until the time at which the participant would normally swallow the remaining materials from the disintegrated tablet. The average disintegration time will be calculated for each participant based on 3 separate tests.|Day 1|The populations consisted of all enrolled participants.|||Seconds||Full Range|Mean
2606831|NCT02096263|Secondary|Number of Subjects With SAEs.|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|During the 31-day (Days 0-30) post-booster vaccination.|The analysis was done on the Booster Total Vaccinated cohort, which included all subjects with documented administration of the booster vaccine.|||Participants|||Count of Participants
2606832|NCT02096263|Secondary|Number of Subjects With Unsolicited AEs.|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) post-booster vaccination.|The analysis was done on the Booster Total Vaccinated cohort, which included all subjects with documented administration of the booster vaccine.|||Participants|||Count of Participants
2606833|NCT02096263|Secondary|Number of Subjects With Specific AEs.|Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)|During the 31-day (Days 0-30) post-booster vaccination.|The analysis was done on the Booster Total Vaccinated cohort, which included all subjects with documented administration of the booster vaccine.|||Participants|||Count of Participants
2606865|NCT02096263|Secondary|Number of Seroprotected Subjects Against Polyribosyl Ribitol Phosphate (Anti-PRP).|A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL.|At Month 5, one month after the third dose of the primary vaccination|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||Participants|||Count of Participants
2606834|NCT02096263|Secondary|Number of Subjects With Solicited General Symptoms.|The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C and ≤ 40.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.|During the 4-day (Days 0-3) post-booster vaccination.|The analysis was done on the Booster Total Vaccinated cohort, which included all subjects with documented administration of the booster vaccine and with the symptoms sheet completed.|||Participants|||Count of Participants
2606835|NCT02096263|Secondary|Number of Subjects With Solicited Local Symptoms.|The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness (Red)/Swelling (Swe): > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.|During the 4-day (Days 0-3) post-booster vaccination.|The analysis was done on the Booster Total Vaccinated cohort, which included all subjects with documented administration of the booster vaccine and with the symptoms sheet completed.|||Participants|||Count of Participants
2606836|NCT02096263|Secondary|Antibody Concentrations for Anti-HBs.|Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 10 mIU/mL.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||mIU/mL||95% Confidence Interval|Geometric Mean
2606837|NCT02096263|Secondary|Number of Seroprotected Subjects Against Anti-HBs.|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||Participants|||Count of Participants
2606838|NCT02096263|Secondary|Antibody Titres for Anti-polio Types 1, 2 and 3.|Titres were expressed as geometric mean titres (GMTs) for the cut-off of 8 dilution.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||titres||95% Confidence Interval|Geometric Mean
2606839|NCT02096263|Secondary|Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3.|A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titres ≥ 8 dilution.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||Participants|||Count of Participants
2606840|NCT02096263|Secondary|Antibody Concentrations for Anti-PRP.|Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 1 µg/mL.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||µg/mL||95% Confidence Interval|Geometric Mean
2606841|NCT02096263|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL.|The cut-off for this assay was an anti-PRP concentration ≥ 1 µg/mL.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||Participants|||Count of Participants
2606842|NCT02096263|Secondary|Number of Seroprotected Subjects Against Anti-PRP.|A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||Participants|||Count of Participants
2606843|NCT02096263|Secondary|Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN.|"Booster response to PT, FHA and PRN antigens was defined as:~For subjects with pre-vaccination antibody concentration below the assay cut off, post-vaccination antibody concentration equal or above 4 times the assay cut-off.~For subjects with pre-vaccination antibody concentration between the assay cut off and below 4 times the assay cut-off, post-vaccination antibody concentration equal or above 4 times the pre-vaccination antibody concentration.~For subjects with pre-vaccination antibody concentration equal or above 4 times the assay cut-off, post-vaccination antibody concentration of at least two times the pre-vaccination antibody concentration.~The assay cut off is 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN."|At Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||Participants|||Count of Participants
2606866|NCT02096263|Secondary|Antibody Titres for Anti-polio Types 1, 2 and 3.|Titres were expressed as geometric mean titres (GMTs) for the cut-off of 8 dilution.|At Month 5, one month after the third dose of the primary vaccination|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||titres||95% Confidence Interval|Geometric Mean
2606845|NCT02096263|Secondary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.|A seropositive subject was defined as a subject with antibody concentrations above to or equal to (≥) 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.|At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||Participants|||Count of Participants
2606846|NCT02096263|Secondary|Antibody Concentrations for Anti-D.|Concentrations were expressed as GMCs for the seropositivity cut-off of 0.1 IU/mL.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||IU/mL||95% Confidence Interval|Geometric Mean
2606847|NCT02096263|Secondary|Antibody Concentrations for Anti-T.|Concentrations were expressed as GMCs for the seropositivity cut-off of 0.1 IU/mL.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||IU/mL||95% Confidence Interval|Geometric Mean
2606848|NCT02096263|Secondary|Number of Seroprotected Subjects Against Anti-D.|A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 IU/mL.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||Participants|||Count of Participants
2606849|NCT02096263|Secondary|Number of Seroprotected Subjects Against Anti-T.|A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 IU/mL.|At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)]|The analysis was done on the Booster ATP cohort for immunogenicity, which included all subjects who complied with the protocol and study procedures up to the post-dose 4 blood sample and had immunogenicity results for the post-dose 4 blood sample.|||Participants|||Count of Participants
2606850|NCT02096263|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Month 0 up to 6 months post-primary vaccination (Month 10)|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2606851|NCT02096263|Secondary|Number of Subjects With Unsolicited AEs.|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 31-day (Days 0-30) post-primary vaccination period.|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2606852|NCT02096263|Secondary|Number of Subjects With Specific Adverse Events (AEs).|Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)|From Month 0 up to 6 months post primary-vaccination (Month 10)|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2606853|NCT02096263|Secondary|Number of Subjects With Solicited General Symptoms.|The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.|During the 4-day (Days 0-3) post-vaccination period following any dose.|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.|||Participants|||Count of Participants
2606854|NCT02096263|Secondary|Number of Subjects With Solicited General Symptoms.|The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Feve:r > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.|During the 4-day (Days 0-3) post-vaccination period following Dose 3.|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.|||Participants|||Count of Participants
2606867|NCT02096263|Secondary|Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3.|A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titres ≥ 8 dilution.|At Month 5, one month after the third dose of the primary vaccination|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||Participants|||Count of Participants
2606855|NCT02096263|Secondary|Number of Subjects With Solicited General Symptoms.|The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.|During the 4-day (Days 0-3) post-vaccination period following Dose 2.|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.|||Participants|||Count of Participants
2606856|NCT02096263|Secondary|Number of Subjects With Solicited General Symptoms.|The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: > 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: > 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.|During the 4-day (Days 0-3) post-vaccination period following Dose 1.|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.|||Participants|||Count of Participants
2606857|NCT02096263|Secondary|Number of Subjects With Solicited Local Symptoms.|The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness (Red)/Swelling (Swe): > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.|During the 4-day (Days 0-3) post-vaccination period following any dose.|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.|||Participants|||Count of Participants
2606858|NCT02096263|Secondary|Number of Subjects With Solicited Local Symptoms.|The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness (Red)/Swelling (Swe): > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA|During the 4-day (Days 0-3) post-vaccination period following Dose 3|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.|||Participants|||Count of Participants
2606859|NCT02096263|Secondary|Number of Subjects With Solicited Local Symptoms.|The solicited local symptoms assessed were pain, redness (Red) and swelling (Swe). Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.|During the 4-day (Days 0-3) post-vaccination period following Dose 2|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.|||Participants|||Count of Participants
2606860|NCT02096263|Secondary|Number of Subjects With Solicited Local Symptoms.|The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: > 5 millimeters (mm); Grade 3 Redness/Swelling: > 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.|During the 4-day (Days 0-3) post-vaccination period following Dose 1|The analysis was done on the Primary Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and who had their symptoms sheet completed.|||Participants|||Count of Participants
2606861|NCT02096263|Secondary|Antibody Concentrations for Anti-HBs.|Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 10 mIU/mL.|At Month 5, one month after the third dose of the primary vaccination|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||mIU/mL||95% Confidence Interval|Geometric Mean
2606862|NCT02096263|Secondary|Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs).|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mili-International units per mililiter (mIU/mL).|At Month 5, one month after the third dose of the primary vaccination|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||Participants|||Count of Participants
2606863|NCT02096263|Secondary|Antibody Concentrations for Anti-PRP.|Antibody concentrations were expressed as GMCs for the assay cut-off of 1 µg/mL.|At Month 5, one month after the third dose of the primary vaccination|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||µg/mL||95% Confidence Interval|Geometric Mean
2606864|NCT02096263|Secondary|Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL.|The cut-off for this assay was an anti-PRP concentration ≥ 1 µg/mL.|At Month 5, one month after the third dose of the primary vaccination|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||Participants|||Count of Participants
2606868|NCT02096263|Secondary|Antibody Concentrations for Anti-D.|Concentrations were expressed as GMCs for the seroprotection cut-off of 0.1 IU/mL.|At Month 5, one month after the third dose of the primary vaccination|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||IU/mL||95% Confidence Interval|Geometric Mean
2606869|NCT02096263|Secondary|Antibody Concentrations for Anti-T.|Concentrations were expressed as GMCs for the seroprotection cut-off of 0.1 IU/mL.|At Month 5, one month after the third dose of the primary vaccination|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||IU/mL||95% Confidence Interval|Geometric Mean
2606870|NCT02096263|Secondary|Number of Seroprotected Subjects Against Diphtheria (D).|A seroprotected subject was defined a a subject with antibody concentrations ≥ 0.1 IU/mL.|At Month 5, one month after the third dose of the primary vaccination.|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||Participants|||Count of Participants
2606871|NCT02096263|Secondary|Number of Seroprotected Subjects Against Tetanus (T).|A seroprotected subject was defined a a subject with antibody concentrations ≥ 0.1 IU/mL.|At Month 5, one month after the third dose of the primary vaccination.|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||Participants|||Count of Participants
2606872|NCT02096263|Secondary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.|A seropositive subject was defined as a subject with antibody concentrations above to or equal to (≥) 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.|At Month 5, one month after the third dose of the primary vaccination.|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||Participants|||Count of Participants
2606873|NCT02096263|Primary|Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN).|Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. The results for the Infanrix hexa Group and Pediarix Group were the primary outcome variables.|At Month 5, one month after the third dose of the primary vaccination.|The analysis was done on the Primary According to Protocol (ATP) cohort for immunogenicity, which included all subjects who complied with the protocol up to the post-dose 3 blood sample and who had immunogenicity results for the post-dose 3 blood sample.|||IU/mL||95% Confidence Interval|Geometric Mean
2606874|NCT02096107|Secondary|Infection|Compare the rates of post-transplant infections, including CMV, BK, and admissions to the hospital for infectious causes in each group.|2 year||||percentage of subjects with infection|||Number
2606875|NCT02096107|Secondary|Adverse Drug Reactions|Measure and compare the incidence of significant immunosuppressant-related adverse drug reactions for each group.|2 year||||Participants|||Count of Participants
2606876|NCT02096107|Secondary|Percentage of Participants Discontinuing or Modifying Immunosuppressant Use|Measure and compare the rates of immunosuppressant discontinuation and modification for each group.|2 year||||percentage of participants|||Number
2606877|NCT02096107|Secondary|Kidney Allograft Survival|Compare the patient and graft survival rates at one-year post-transplant in each group.|1 year||||percentage of patients graft survival|||Number
2606878|NCT02096107|Secondary|Renal Function Measured by Estimated Glomerular Filtration Rate (eGFR)|Measure and compare the estimated GFR (using the 4-variable modified MDRD equation) in patients converted to everolimus, low intensity tacrolimus and prednisone versus the standard of care tacrolimus, mycophenolate and prednisone regimen, both at one year and two years post-transplant.|1 year||||mL/min/1.73 m^2||Standard Deviation|Mean
2606879|NCT02096107|Primary|Kidney Allograft Fibrosis Assessment|"Measure and compare the change in interstitial fibrosis (morphometric analysis of trichrome stained slides) at one-year post-transplant in patients converted to everolimus, low intensity tacrolimus and prednisone versus the standard of care tacrolimus, mycophenolate and prednisone regimen.~The scale is a percentage of the tissue that demonstrates fibrosis. The scale range is 0 to 100%. The higher the percentage, the worse the fibrosis and the poorer the prognosis. A lower score (percentage) is therefore better."|1 year|The number of subjects analyzed for the fibrosis assessment was 15 in each group, because biopsy samples for both baseline and end of follow-up were only able to be obtained from 15 subjects per group.|||% of fibrosis||Inter-Quartile Range|Mean
2606880|NCT02096081|Secondary|Subject Perception of Treatment Peak Effect|Assessment of subject perception of date of treatment peak effect using a take-home diary|Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary.|This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified.|||participants|||Number
2606881|NCT02096081|Secondary|Subject Perception of Treatment Onset|Assessment of subject perception of date of treatment onset using a take-home diary|Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary.|This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified.|||days||Full Range|Median
2606882|NCT02096081|Secondary|Subject Satisfaction|"Assessment of subject treatment satisfaction by subject questionnaire and diary at 4 months from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as Satisfaction and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as Dissatisfaction. Subjects with missing data were categorized as Missing."|4 months from baseline|This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified.|||participants|||Number
2606883|NCT02096081|Secondary|Subject Satisfaction|"Assessment of subject treatment satisfaction by subject questionnaire and diary at 3 months from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as Satisfaction and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as Dissatisfaction. Subjects with missing data were categorized as Missing."|3 months from baseline|This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified.|||participants|||Number
2606884|NCT02096081|Secondary|Subject Satisfaction|"Assessment of subject treatment satisfaction by subject questionnaire and diary at 2 months from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as Satisfaction and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as Dissatisfaction. Subjects with missing data were categorized as Missing."|2 months from baseline|This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified.|||participants|||Number
2606885|NCT02096081|Secondary|Subject Satisfaction|"Assessment of subject treatment satisfaction by subject questionnaire and diary at 1 month from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as Satisfaction and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as Dissatisfaction. Subjects with missing data were categorized as Missing."|1 month from baseline|This endpoint was analyzed using observed cases in the per protocol set (PPS), defined as the subset of subjects in the FAS from whom no major protocol deviations were identified.|||participants|||Number
2606886|NCT02096081|Secondary|Response at Maximum Frown Rated by Treating Physician|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 4 months from treatment.|4 months from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.|||percentage of participants|||Number
2606887|NCT02096081|Secondary|Response at Maximum Frown Rated by Treating Physician|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 3 months from treatment.|3 months from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.|||percentage of participants|||Number
2606888|NCT02096081|Secondary|Response at Maximum Frown Rated by Treating Physician|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 2 months from treatment.|2 months from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.|||percentage of participants|||Number
2606889|NCT02096081|Secondary|Response at Maximum Frown Rated by Treating Physician|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 1 month from treatment.|1 month from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.|||percentage of participants|||Number
2606890|NCT02096081|Secondary|Response at Maximum Frown Rated by Independent Rater|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 4 months from baseline.|4 months from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.|||percentage of participants|||Number
2606891|NCT02096081|Secondary|Response at Maximum Frown Rated by Independent Rater|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 3 months from baseline.|3 months from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.|||percentage of participants|||Number
2606892|NCT02096081|Secondary|Response at Maximum Frown Rated by Independent Rater|Response defined as ≥ 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 2 months from baseline.|2 months from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.|||percentage of participants|||Number
2606893|NCT02096081|Primary|Efficacy, Measured as the Percentage of Participants Who Responded to Treatment|Response defined as ≥ 1 point improvement from baseline (prior to treatment) on the Facial Wrinkle Scale at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 1 month from treatment.|1 Month from baseline|All efficacy analyses were performed on the per protocol set (PPS) defined as the subset of subjects in the FAS for whom no major protocol deviations were identified.|||percentage of participants|||Number
2606894|NCT02096042|Primary|Overall Response Rate|Response defined as number of participants with complete response (CR), CR with incomplete platelet recovery (CRp), CR with insufficient hematological recovery (CRi) or partial remission (PR).|Response assessed after four 28-day cycles, up to 120 days|Study was stopped with only one participant; no analysis done on outcome.||||||
2606895|NCT02096042|Primary|Maximum Tolerated Dose (MTD) of Brentuximab Vedotin in Combination With 5-Azacytidine|MTD defined as maximum dose at which <33% of patients experience a dose-limiting toxicity (DLT) during cycle 1.|After 1, 28 day cycle|Study terminated early.||||||
2606896|NCT02096029|Secondary|Use of Any Smoking Cessation Medication||From study enrollment through end of six-month follow up||||percentage of participants|||Number
2606897|NCT02096029|Secondary|Any Self-defined Attempt to Stop Smoking Cigarettes||From study enrollment through end of six-month follow up||||percentage of participants|||Number
2606905|NCT02095951|Secondary|Number of Adverse Events Per Episode of Catheter Infection|Number of Adverse events per episode of distinct catheter infection that are thought to be related to the actual study intervention, namely timing of ethanol lock placement, will be reviewed and reported for each individual infection episode/admission.|Participants will be followed for the duration of hospital stay, an expected average of 2 weeks but up to 1 month post the last ethanol dose administration|1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group.|||Adverse Events|Catheter Infection Episodes (cases)||Number
2606906|NCT02095951|Secondary|Catheter Salvage|Number of Infected catheters (which achieved sterilization) with salvage for at least 14 days.|Participants will be followed for the duration of hospital stay, an expected average of 2 weeks|1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group.|||Catheters|Catheters||Number
2606907|NCT02095951|Secondary|Catheter Sterilization|Number of Catheters sterilized with interventions|Participants will be followed for the duration of hospital stay, an expected average of 2 weeks|1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group.|||Catheters|Catheters||Number
2606908|NCT02095951|Primary|Hospital COSTS in 14 Confirmed Catheter Related Infection Cases|Hospital COSTS|Participants will be followed for the duration of hospital stay, an expected average of 2 weeks|1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group.|||USD $|Catheters|Standard Deviation|Mean
2606909|NCT02095951|Primary|Attributable Length of Stay (ALOS) in 14 Confirmed Catheter Related Infection Cases|TIME FROM FIRST POSITIVE TO FIRST NEGATIVE BLOOD CULTURE|Participants will be followed for the duration of hospital stay, an expected average of 2 weeks|1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group.|||HOURS|Catheter Infection Episodes (cases)|Standard Deviation|Mean
2606910|NCT02095951|Primary|Length of Stay (LOS) in Those With 14 Confirmed Catheter Related Infection Cases|A primary endpoint of this study is length of stay (LOS) per catheter infection episode/admission|Participants will be followed for the duration of hospital stay, an expected average of 2 weeks|1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group.|||HOURS|Catheter Infection Episodes (cases)|Standard Deviation|Mean
2606911|NCT02095873|Other Pre-specified|Aortal Pulse Wave Velocity (aPWV)|Aortal pulse wave velocity is measured by a non-invasive oscillometric device.|Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)|Subjects for which PWV data were obtained at baseline and post 8-weeks treatment.|||m/s||Inter-Quartile Range|Median
2606912|NCT02095873|Secondary|Flow-mediated Dilatation (FMD)|Brachial artery FMD will be assessed. Ultrasound imaging of the brachial artery will be performed. Percent FMD will be calculated using the averaged minimum mean brachial artery diameter at baseline compared to the largest mean values obtained after either release of the forearm occlusion.|Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)|All subjects completing the study per protocol|||percentage of baseline value||Inter-Quartile Range|Median
2606913|NCT02095873|Secondary|Finger-fold Capillary Density by Capillaroscopy|After 20 min seated at rest, measurements are made with the subject seated and the left hand at heart level. Nail-fold capillaries in the dorsal skin of the third finger are visualized using a stereo microscope linked to a monochrome digital camera. Capillary density is defined as the number of capillaries per mm2 of nail-fold skin and is computed as the mean of 4 measurements.|Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)|All subjects with where baseline and post-8 treatment data were obtained.|||number of capillaries per mm2||Inter-Quartile Range|Median
2606914|NCT02095873|Primary|Area Under the Curve for Oral Glucose Tolerance Test (oGGT)|A standard 75 g glucose oGTT will be performed, as routinely used in clinical practice. Participants will be instructed to eat carbohydrate rich diet (> 150 g/day) for at least three days before the test, followed by an overnight fast. Participants will be instructed to have comparable macronutrient composition of the dinner before the respective study days in the metabolic unit. During the oGTT both capillary and venous blood samples will be collected after 0, 15, 30, 60, 90 and 120 min. To minimize the inconvenience of repeated blood tests during the oGTT, a venous cannula will be inserted, under sterile conditions, prior to the test, for blood sampling.|Week 0 and Week 8 (first intervention); Week 14 and Week 22 (second intervention)|Highly overweight/obese (BMI>27.5 kg/m2) subgroup, based on subject BMI at study entry.|||mM h||Standard Error|Mean
2606915|NCT02095691|Secondary|Incidence of Subjects Achieving a ≥ 10 mmHg Reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure|Incidence of subjects achieving a 10 mmHg or more reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 months post procedure.|12 months post-procedure|Effectiveness analysis population, which consists of enrolled subjects without enrollment deviation and experiencing technical success. Technical success is defined as the investigational catheter being successfully inserted into the femoral artery with radiofrequency energy successfully applied in at least one artery.|||percentage of participants|||Number
2606916|NCT02095691|Secondary|Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure|The pre-specified target SBP is defined as SBP <130 mmHg. This endpoint is defined at each of 1, 3, 6 and 12 months post procedure.|12 months post-procedure|Effectiveness analysis population, which consists of enrolled subjects without enrollment deviation and experiencing technical success. Technical success is defined as the investigational catheter being successfully inserted into the femoral artery with radiofrequency energy successfully applied in at least one artery.|||percentage of participants|||Number
2606917|NCT02095691|Secondary|Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure|Office systolic blood pressure (SBP) and diastolic blood pressure (DBP) measures were summarized to assess the reduction in blood pressure from baseline visit to post baseline at 1, 3, 6, and 12 months. Negative values for change represent reductions.|12 months post-procedure|Effectiveness analysis population, which consists of enrolled subjects without enrollment deviation and experiencing technical success. Technical success is defined as the investigational catheter being successfully inserted into the femoral artery with radiofrequency energy successfully applied in at least one artery.|||mmHg||Standard Deviation|Mean
2607087|NCT02093897|Secondary|Area Under the Concentration Curve (AUC)|AUC to the last sample with quantifiable drug concentration (AUC0-t), baseline uncorrected; plasma FVIII activity measured using the chromogenic substrate assay.|Immediately before dosing, and at approximately 1, 5, 10, 24, and 48 hours after dosing.|PK Population|||IU*h/dL||Standard Deviation|Mean
2606918|NCT02095691|Secondary|Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit|These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); peri-procedural renal artery dissection or perforation requiring intervention, serious arterial access site related complications requiring intervention or prolonging hospitalization; ≥25% reduction between baseline and 12 months in renal function measured by the estimated Glomerular Filtration Rate (eGFR), as well as composite of major adverse cardiovascular and/or renal events.|12 months post-procedure|The safety analysis population consists of all enrolled subjects who have undergone insertion of the study ablation catheter.|||percentage of participants|||Number
2606919|NCT02095691|Primary|Incidence of Major Adverse Events That Occurred Within 30 Days Post-procedure.|Major adverse events include Acute myocardial infarction; Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death; New-onset heart failure; Stroke; Aortic or lower limb revascularization procedure; Lower limb amputation; Beginning dialysis; Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit; Hospitalization for atrial fibrillation.|30 days post-procedure|The Safety Analysis population which consists of all enrolled subjects who have undergone insertion of the study ablation catheter.|||percentage of participants|||Number
2606920|NCT02095561|Secondary|HPV Positivity|Calculated as the percentage of women with positive HPV test over total number of tested women, both for women with self-testing and those HPV tests taken at health centers.|within 6 months after the CHW visits|Population included in the HPV self-testing group to calculate positivity includes only women who were self-tested (n=2519). It excludes 99 women from this group who were not self-tested and were tested at health centers.|||percentage of positive tests/tested wome|||Number
2606921|NCT02095561|Secondary|CIN2+ Detection Rate|calculated as the percentage of women with histologically confirmed CIN2+ over total number of tested women, both for women with self-testing and those HPV tests taken at health centers.|within one year after the CHW visits|Population included in the HPV self-testing group to calculate CIN2+ detection rate includes only women who were self-tested (n=2519). It excludes 99 women from this group who were not self-tested and were tested at health centers.|||percentage of CIN2+/ women screened|||Number
2606922|NCT02095561|Secondary|Acceptability|Defined as the proportion of women from the intervention group who were offered self-testing and accepted, as documented in the questionnaire, independently of if they ended up with a test in the information system.|within 6 months||||participants|||Number
2606923|NCT02095561|Primary|Screening Uptake|The primary outcome was screening uptake, defined as: a) the proportion of participant women with any HPV test (self-test or HPV at health centers) in the information system, in the 6 months after the CHW visit, and b) the proportion of women in the intervention group with a self-test in SITAM, in the same 6 month period.|within 6 months after the intervention||||participants|||Number
2606924|NCT02095535|Primary|Length of Drying Time|Length of drying time from when Chloraprep solution is applied to skin to when skin is deemed dry.|At Chloraprep application||||seconds||Standard Deviation|Mean
2606925|NCT02095340|Primary|Maternal Anxious Behavior Coded by Independent Observers.|Maternal anxious behavior coded by independent observers on a 0 - 4 scale. Higher numbers indicated more observed anxious behaviors.|Immediately after the intervention, an average of 10 minutes.||||units on a scale||Standard Deviation|Mean
2606926|NCT02095340|Primary|Word Sentence Association Paradigm|Proportion of threatening (versus nonthreatening) interpretations made on the Word Sentence Association Paradigm (WSAP). Scores range from 0 to 1. Higher scores mean a worse outcome, that is, more negative interpretations.|Participants will be assessed, on average, within 20 minutes after the intervention.|Data for one participant in the positive training condition and two participants in the neutral training condition was lost due to equipment malfunction.|||units on a scale||Standard Deviation|Mean
2606927|NCT02095223|Secondary|Change From Baseline in Quadriceps Hoffmann Reflex|We will record muscle reflex activity by delivering a short percutaneous (through the skin) electrical stimulation to femoral nerve located in the inguinal fold. We will measure the reflex response of the quadriceps with surface electromyography. Subjects will be positioned comfortably in a lying-down position on a treatment table. Stimuli will be delivered to the femoral nerve by increasing the intensity in small increments with a 10-sec rest interval after each stimulus, until the maximum H-reflex amplitude is recorded (Hmax). The H-reflex represents the proportion of the quadriceps motor neuron pool that is available for voluntary contraction and the M-wave represents the total volume of the quadriceps motor neuron pool and will be used to normalize the H-reflex recordings as H:M ratio. This measurement will be performed bilaterally.|Baseline and 14 days|This measure was exclude from the study protocol due to an issue with the equipment utilized to generate the electical pulse. No participants of this study completed the Hoffmann reflex testing protocol at baseline or follow-up visits.||||||
2606928|NCT02095223|Primary|Change From Baseline in Quadriceps Central Activation Ratio|Subjects will be secured to a chair (Biodex multi-mode dynamometer) with their knees and hips bent to approximately 90-degrees. Subjects will perform a maximal, voluntary isometric knee extension contraction (MVIC) with continuous verbal encouragement from the tester. Once the MVIC reaches a plateau (representing subjects' maximal effort) an electrical stimulus will be manually triggered and delivered directly to the quadriceps through 2 stimulating electrodes which will be secured to the subjects' anterior thigh. The stimulus will cause the quadriceps to twitch resulting in a temporary increase in force production which we will measure. A ratio between the MVIC force and the highest force achieved due to the electrical stimulation will be calculated - this is called the central activation ratio.|Baseline and 14 days||||percentage change from baseline||Standard Deviation|Mean
2606929|NCT02095197|Secondary|Greater Than or Equal to a 30% Reduction in Oswestry Neck Disability Index Score|This questionnaire has been designed to give us information to how neck pain has affected the ability to manage in everyday life. There are ten sections, 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'. All the points can be summed to a total score. The maximum points scored is 50. The reported score divided by 50 is then transformed to a percentage score by multiplying by 100. The Minimum dectectable change (90 % confidence) is 5 points or 10 percent.|1 month|Both demonstrate a difference from pretreatment baseline (P=0.05).|||Participants|||Count of Participants
2626155|NCT01903863|Secondary|Hemorrhagic and Thrombotic Complications|Complications associated with coagulation in both the patient and the pump will be collected.|ECMO course (median 198 hours)||||participants|||Number
2606930|NCT02095197|Secondary|Patient Global Impression of Change Score (PGIC) Less Than 3|"PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as:~1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse.~A PGIC score less than 3 means the patient reported much improved to very much improved."|1 month||||Participants|||Count of Participants
2606931|NCT02095197|Secondary|Decrease of > 6.8 Point Reduction in Medication Quntification Scale (MQS-III)|The Medication Quantification Scale was designed as a method of quantifying different drug regimens (Harden et al, Journal of Pain, 2005). The detriment weights derived from the healthcare survey for each of the 22 medication classes are the critical values that when multiplied by a dosage score it gives a patient MQS score. It computes a single numeric value for a patient's pain medication profile. We recorded the names and doses of each medication being used then quantified the total burden of each subject's medication using the MQS-III. which assigns a measurement to each drug based on both the dose taken and its burdensomeness (derived from expert consensus).|1 month||||Participants|||Count of Participants
2606932|NCT02095197|Primary|Percentage of Participants With ≥50% Pain Reduction on the Numeric Rating Score (NRS) for Pain|"The percentage of participants who reported ≥50% pain reduction on the numeric rating score for pain at the 1 month follow-up assessment period.~Numeric Rating Scale (NRS) for pain consists of a range where 0 (is no pain) and 10 (is extreme pain).~Percentage of participants with pain reduction = 100% (number of participants with pain reduction/all participants)"|1 month||||percentage of participants||95% Confidence Interval|Number
2606933|NCT02095158|Secondary|Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Satisfaction Assessment (SSA) Using 5-Point Scales|The investigator assessed the participant's overall severity of erythema in the treatment area by using the 5-point CEA scale with photonumeric guide where: 0=clear skin with no signs of erythema (best) to 4=severe erythema; fiery redness (worst). A decrease in the score indicates improvement. The participant assessed their overall severity of rosacea facial redness in the treatment area by using the 5-point SSA scale with photoguide where: 0=no signs of unwanted redness (best) to 4=severe redness (worst). A decrease in the score indicates improvement. The percentage of participants with at least a 2-grade decrease (improvement) on both CEA and SSA from Baseline was evaluated over the 6-hour evaluation period (hours 3 and 6) post-dose.|Baseline, Day 1 Hours 3 and 6, Week 4 Predose and Hours 3 and 6, Week 12 Predose, Week 26 Predose and Hours 3 and 6, Week 39 Predose, Week 52 Predose and Hours 3 and 6, Week 54 Predose|Modified-intent-to-treat (mITT) population consisted of all participants who had at least 1 post-baseline CEA and SSA measurement.|||percentage of participants|||Number
2606934|NCT02095158|Primary|Percentage of Participants With Treatment-Related Adverse Events|An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A Treatment-Related Adverse Event is an Adverse Event determined by the investigator to be causally related to the study medication.|56 Weeks|Safety population included all participants who received at least 1 dose of study medication.|||percentage of participants|||Number
2606935|NCT02095145|Secondary|Change in Biopsy Tumor Involvement on Prostate Biopsy|Change in the length of biopsy cores that contained cancerous tissue from Baseline to end of study.|Baseline to 1 year|One participant has a baseline measurement but does not have an end of study measurement, a change in the biopsy tumor involvement for this participant is therefore not possible to calculate.|||mm||Standard Deviation|Mean
2606936|NCT02095145|Secondary|Change in Gleason Score|The Gleason Score is a grading system used to determine the aggressiveness of prostate cancer, scored 1-5 with 1 being healthy tissue and 5 being abnormal. Prostate cancers are assigned 2 scores to define the 2 most prevalent tissue types. They are added together (total range of 2-10). Typical scores fall between 6-10, the higher the overall score, the more likely the cancer will spread.|Baseline to 1 year||||Participants|||Count of Participants
2606937|NCT02095145|Secondary|Change in Levels of PFE Constituents/Metabolites: Urolithin B|Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.|Change from Baseline at Week 13, Week 26, Week 39, and Week 52||||ng||Standard Deviation|Mean
2606938|NCT02095145|Secondary|Change in Levels of Pomegranate Fruit Extract (PFE) Constituents/Metabolites: Urolithin A|Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.|Change from Baseline at Week 13, Week 26, Week 39, and Week 52||||ng||Standard Deviation|Mean
2606939|NCT02095145|Secondary|Change in Tissue Biomarker Levels: AR|"Compare and correlate biomarker modulation in response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core (benign in results), tumor tissue from a positive core (tumor in results), and normal tissue adjacent to tumor from a positive core (adjacent in results). Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used."|Baseline to Week 52|The number analyzed depends on the identification and recovery of relevant tissue type (benign, adjacent, tumor).|||normalized optical density||Standard Deviation|Mean
2606940|NCT02095145|Secondary|Change in Tissue Biomarker Levels: 8OHdG|"Compare and correlate biomarker modulation in response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core (benign in results), tumor tissue from a positive core (tumor in results), and normal tissue adjacent to tumor from a positive core (adjacent in results). Measurements for each are per nuclear (Nuc in results), cytoplasmic (Cyt in results), and cellular (Cell in results) basis. Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used."|Baseline to Week 52|The number analyzed depends on the identification and recovery of relevant tissue type (benign, adjacent, tumor).|||normalized optical density||Standard Deviation|Mean
2606941|NCT02095145|Secondary|Change in Tissue Biomarker Levels: IGF-Rb|"Compare and correlate biomarker modulation in response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core (benign in results), tumor tissue from a positive core (tumor in results), and normal tissue adjacent to tumor from a positive core (adjacent in results). Measurements for each are per nuclear (Nuc in results), cytoplasmic (Cyt in results), and cellular (Cell in results) basis. Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used."|Baseline to Week 52|The number analyzed depends on the identification and recovery of relevant tissue type (benign, adjacent, tumor).|||normalized optical density||Standard Deviation|Mean
2606942|NCT02095145|Secondary|Change in Tissue Biomarker Levels: Ki-67|"Compare and correlate biomarker modulation in response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core (benign in results), tumor tissue from a positive core (tumor in results), and normal tissue adjacent to tumor from a positive core (adjacent in results). Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used."|Baseline to Week 52|The number analyzed depends on the identification and recovery of relevant tissue type (benign, adjacent, tumor).|||percent change||Standard Deviation|Mean
2606943|NCT02095145|Secondary|Change in Tissue Biomarker Levels: CASP3|"Compare and correlate biomarker modulation in response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core (benign in results), tumor tissue from a positive core (tumor in results), and normal tissue adjacent to tumor from a positive core (adjacent in results). Measurements for each are per nuclear (Nuc in results), cytoplasmic (Cyt in results), and cellular (Cell in results) basis. Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used."|Baseline to Week 52|The number analyzed depends on the identification and recovery of relevant tissue type (benign, adjacent, tumor).|||normalized optical density||Standard Deviation|Mean
2606944|NCT02095145|Secondary|Change in Tissue Biomarker Levels: IGFBP-3|"Compare and correlate biomarker modulation in response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core (benign in results), tumor tissue from a positive core (tumor in results), and normal tissue adjacent to tumor from a positive core (adjacent in results). Measurements for each are per nuclear (Nuc in results), cytoplasmic (Cyt in results), and cellular (Cell in results) basis. Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used."|Baseline to Week 52|The number analyzed depends on the identification and recovery of relevant tissue type (benign, adjacent, tumor).|||normalized optical density||Standard Deviation|Mean
2606945|NCT02095145|Secondary|Change in Tissue Biomarker Levels: IGF-1|"Compare and correlate biomarker modulation in response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core (benign in results), tumor tissue from a positive core (tumor in results), and normal tissue adjacent to tumor from a positive core (adjacent in results). Measurements for each are per nuclear (Nuc in results), cytoplasmic (Cyt in results), and cellular (Cell in results) basis. Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used."|Baseline to Week 52|The number analyzed depends on the identification and recovery of relevant tissue type (benign, adjacent, tumor).|||normalized optical density||Standard Deviation|Mean
2606946|NCT02095145|Secondary|Change in Tissue Biomarker Levels: PSA|"Compare and correlate biomarker modulation in response to PFE versus placebo in three areas of interest: tissue from a completely benign biopsy core (benign in results), tumor tissue from a positive core (tumor in results), and normal tissue adjacent to tumor from a positive core (adjacent in results). Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used."|Baseline to Week 52|The number analyzed depends on the identification and recovery of relevant tissue type (benign, adjacent, tumor).|||normalized optical density||Standard Deviation|Mean
2606947|NCT02095145|Secondary|Prostate Specific Antigen Doubling Time (PSA DT)|PSA DT will be determined from PSA values obtained during study participation (baseline and weeks 13, 26, 39 and 52). The secondary endpoint of PSA DT is based on the value at study completion (week 52 or at point of early termination). However, PSA DT will be determined starting at week 26 (the earliest time point with 3 values) and week 39 and recorded. PSA doubling time is a measure based on the slope of the PSA at multiple time points. If the slope is relatively flat, the predicted doubling time could be far beyond the length of the actual study. As such, the value is not limited to the time frame over which data is collected from the participant.|up to 52 Weeks|One of the participant's PSA values were 'non-detectable', therefore PSA observations could not be calculated for that participant.|||weeks||Standard Deviation|Mean
2606948|NCT02095145|Secondary|Change in Serum Testosterone||up to 1 year||||pg/ml||Standard Deviation|Mean
2606949|NCT02095145|Secondary|Change in Total Serum Prostate Specific Antigen (PSA) From Baseline||Up to 1 year|Statistician notes that serum PSA data is missing for one participant in the pomegranate extract arm for all time points, missing for another in the pomegranate arm at week 39, and one from the placebo arm at week 39.|||ng/mL||Standard Deviation|Mean
2607088|NCT02093897|Secondary|Half-life (t1/2) of rVIII-SingleChain|Half-life (t1/2) of rVIII-SingleChain, baseline uncorrected; plasma FVIII activity measured using the chromogenic substrate assay.|Immediately before dosing, and at approximately 1, 5, 10, 24, and 48 hours after dosing.|PK Population|||hour||Standard Deviation|Mean
2606950|NCT02095145|Secondary|Change in Plasma Biomarker Levels From Baseline: IGF-1/GFBP-3|Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.|Week 13, Week 26, Week 39, Week 52||||ratio||Standard Deviation|Mean
2606951|NCT02095145|Secondary|Change in Plasma Biomarker Levels From Baseline: IGFBP-3|Differences between the groups will be examined for the change from baseline with the appropriate tests; for dichotomous data Fisher's exact test will be used, for ordinal data Wilcoxon rank-sum test will be used, and for continuous data, and a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.|Week 13, Week 26, Week 39, Week 52||||ng/mL||Standard Deviation|Mean
2606952|NCT02095145|Secondary|Incidence of Adverse Events Graded Per Common Terminology Criteria for Adverse Events (CTCAE)|Patient toxicity throughout the study will be summarized in several ways; the presence or absence of any toxicity, worst CTCAE grade, and strongest investigator-defined relationship will all be examined and characterized by treatment arm, and analyzed appropriately (Wilcoxon rank-sum for ordinal data, Fisher's exact test for dichotomous data, and log rank test for time to event data).|Up to 1 year||||Participants|||Count of Participants
2606953|NCT02095145|Secondary|Compliance: Number of Participants Who Took Study Drug Per Protocol|Summarized by treatment arm with descriptive statistics, and tested for imbalance using Wilcoxon rank-sum test. Reported for each visit per protocol at Week 13, Week 26, Week 39, and Week 52 (end of study).|Up to 1 year|One participant has no compliance values for weeks 26 and 39.|||Participants|||Count of Participants
2606954|NCT02095145|Primary|Change in Plasma IGF-1 From Baseline to Post-Treatment|The primary endpoint for modulation of intermediate endpoint biomarkers will be the change in the plasma levels of IGF-1 by a quantitative assay (ELISA) from pre-study to post-treatment. The difference between these time points for the placebo group and the pomegranate fruit extract (PFE) group will be tested using a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test.|Baseline to 12 months||||ng/mL||Standard Deviation|Mean
2606955|NCT02095106|Other Pre-specified|Patient Satisfaction|Patient satisfaction with the treatment was measured at the Time of Cast Removal (2 Weeks From Injury for First Intervention Type) and at Final Cast Removal (4 Weeks Post Injury for Second Intervention Type) with a survey that was presented to the patient or parent, asking them to rate the satisfaction on a scale from 1 (less satisfied) to 100 (more satisfied).|4 weeks post-injury||||units on a scale||Full Range|Mean
2606956|NCT02095106|Other Pre-specified|Pain|"Pain was evaluated at the Time of Cast Removal (2 Weeks From Injury for First Intervention Type) and at Final Cast Removal (4 Weeks Post Injury for Second Intervention Type) using the Faces Pain Scale, a validated, highly reliable scale commonly used in the pediatric population. The Faces Pain Scale is a numerical self-report measure of pain intensity developed for children to score the sensation of pain from 0-10. Pictures of 6 cartoon faces ranging from neutral expression of no pain (0) to very much pain (10). Participant is asked to point to the face that shows how much participant hurts at the time of assessment [right now]."|4 weeks post-injury||||score||Full Range|Mean
2606957|NCT02095106|Other Pre-specified|Physical Function|Physical function was evaluated using the Activities Scale for Kids - Performance (ASKp) at the Time of Cast Removal (2 Weeks From Injury for First Intervention Type) and at Final Cast Removal (4 Weeks Post Injury for Second Intervention Type) - to ensure that the measurement represented only the time in which the participant received each type of intervention. The ASKp is a validated, highly reliable, self-reported measure that assesses physical function in children between 5 and 15 years. Scale ranges from 0 to 100 with higher scores representing more physical activity.|4 weeks post-injury||||units on a scale||Full Range|Mean
2606958|NCT02095106|Other Pre-specified|Itchiness|"Itchiness was assessed using a visual analog scale at the Time of Cast Removal (2 Weeks From Injury for First Intervention Type) and at Final Cast Removal (4 Weeks Post Injury for Second Intervention Type). This scale consisted of a horizontal line of 100 mm presented to the patient, with the term no itching at the left end of the scale and the term strong itching appearing at the right end of the scale."|4 weeks post-injury||||units on a scale||Full Range|Mean
2606959|NCT02095106|Secondary|Number of Participants Without Skin Irritation at the Time of Cast Removal (2 Weeks From Injury for First Intervention Type) and at Final Cast Removal (4 Weeks Post Injury for Second Intervention Type)|Skin changes were assessed after removal of the cast by an independent observer blinded to the type of cast that had been removed, with digital photographs obtained and analyzed using Image J Image Processing and Analysis Software to calculate the surface area of any described skin changes as a percentage of total skin area originally covered by the cast.|4 weeks post-injury||||Participants|||Count of Participants
2606960|NCT02095106|Primary|Number of Participants Without Fracture Displacement at 8 Weeks Post Injury|The radiographs at Week 8 were compared with initial radiographs to assess fracture displacement and angulation.|8 weeks post injury||||Participants|||Count of Participants
2606961|NCT02094937|Secondary|Proportion of Subjects With ACT Score >= 20 at Visit 11 (Week 20)|Asthma control test is a five item questionnaire with each response rating from 1 to 5 (1 is severe and 5 is no event) of asthma events over previous 4-weeks. The questions were designed to be self-completed by the participant. The percentage of participants with ACT score >=20 at the end of the Period 2 were analyzed using a logistic regression model including covariates for baseline ACT score, gender, age and treatment group.|Week 20|ITT population. Only those participants who completed the ACT score at the end of Period 2 (Visit 11) were evaluated.|||Percentage of participants||95% Confidence Interval|Number
2606962|NCT02094937|Secondary|Least Squares Mean Change From Baseline in Asthma Control Test (ACT) Score at the End of Period 2|The total ACT score is the sum of the scores attributed to the five questions, ranging from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >=20 indicates well-controlled asthma. The questions were designed to be self-completed by the participant. Mean change from Baseline was calculated as ACT score at the end of Period 2 (Week 20) minus Baseline value. The Baseline value was the predose value at randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented [least square mean(LSM)].|Week 20|ITT population. Only those participants who completed the ACT score at the end of Period 2 (Visit 11) were evaluated.|||Score on scale||Standard Error|Least Squares Mean
2606963|NCT02094937|Secondary|Least Squares Mean Change From Baseline in the Percentage of Rescue Free 24 Hour (hr) Periods During Period 2|The time during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered as a rescue free period. Participants who did not require inhalation of salbutamol (rescue medication) for 24-hours were captured with the help of a daily dairy, all participants were required to record use of rescue medication daily for day and night time separately on e-diary. Mean change from Baseline was calculated as percentage of rescue free 24 hour period during Period 2 (Week 9 to Week 20) minus Baseline value. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented [least square mean (LSM)].|From Week 9 to Week 20|ITT population. Only those participants available at specified time point were analyzed|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
2606964|NCT02094937|Secondary|Least Squares Mean Change From Baseline in the Percentage of Symptom Free 24 Hour Periods During Period 2|Participants who were symptom free for 24-hours were assessed with the help of a daily Dairy. It included the details on daily asthma symptom scores ranging from 0 (no symptoms) to 5-symptoms so severe that participant could not perform normal activity [morning] or to 4-symptoms so severe that participants could not sleep at all [nightly]. Mean change from Baseline was calculated as percentage of symptom free 24 hours during Period 2 (Week 9 to Week 20) minus Baseline. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8). Adjusted mean change from baseline is presented [least square mean (LSM)].|From Week 9 to Week 20|ITT population. Only those participants available at specified time point were analyzed|||Percentage of symptom-free 24-h period||Standard Error|Least Squares Mean
2606965|NCT02094937|Secondary|Least Squares Mean Change From Baseline in Daily Morning (AM) and Evening (PM) PEF Averaged During Period 2|Peak expiratory flow is a person's maximum speed of expiration, as measured with a peak flow meter which determines person's ability to breathe out air. PEF was measured each morning and evening prior to study medication or any rescue salbutamol inhalation aerosol use, using an electronic peak flow meter. Mean change from Baseline was calculated as PEF value averaged during Period 2 (Week 9 to Week 20) minus Baseline. Data is presented separately for morning(AM) and evening(PM) assessments. The Baseline value was the mean of the daily values in one week prior to randomization (Visit 5: Week 8) separately for morning and evening. Adjusted mean change from baseline is presented [least square mean (LSM)].|From Week 9 to Week 20|ITT population. Only those participants available at specified timepoints were analyzed|||Liter per minute (L/min)||Standard Error|Least Squares Mean
2606966|NCT02094937|Secondary|Least Squares Mean Change From Baseline in Clinic Visit Trough FEV1 at the End of Period 2|FEV measures amount of air a person can exhale during a forced breath. The amount of air exhaled in one second of the forced breath is FEV1. Trough FEV1 was measured between 3pm and 11pm excluding Visit 1. Highest value from the three acceptable measurements were recorded. Change from Baseline was calculated as adjusted mean FEV1 value during Period 2 minus Baseline. The Baseline value was the predose value at the randomization (Visit 5: Week 8). Analysis of covariance (ANCOVA) Model was used with covariates of baseline FEV1, gender, age and treatment group. The adjusted mean from this model is presented [least square mean (LSM)].|Week 20|ITT population. Number of participants available for the last post-baseline value during Period 2 were used for analysis.|||Liter||Standard Error|Least Squares Mean
2606967|NCT02094937|Primary|Percentage of Participants With 'Well-controlled Asthma' at the End of Period 2|"Asthma symptom scores(SS) were recorded by par using ratings 0 (no symptoms) to 5-symptoms so severe that par could not perform normal activity[morning] or to 4-symptoms so severe that par could not sleep at all[nightly]. Well-controlled asthma was defined as having no exacerbation/asthma worsening, no night-time symptoms, a best pre-bronchodilator forced expiratory volume in 1 second ≥80% at clinic, and ≥2 per week of: daytime symptoms on ≤1 day, rescue use on ≤1 day, or morning peak expiratory flow ≥80% of the best effort value. Well-controlled asthma at the end of period 2 was assessed in the week prior to Visit 11 (Week 20). Percentage of participants were calculated as the number of participants with well-controlled asthma divided by total number participants excluding withdrawals prior to visit 11 (end of period 2) other than asthma worsening/exacerbation. A Logistic Regression Model was used with covariates of Baseline FEV1, gender, age and treatment group."|Week 20|ITT population. Participants who withdrew prior to Visit 11 for the reasons other than exacerbation were excluded.|||Percentage of Participants||95% Confidence Interval|Number
2606968|NCT02094937|Primary|"Percentage of Participants (Par) Withdrawn From the Study Due to Poorly-controlled Asthma During Period 2"|Asthma symptom scores (SS) were recorded by par using ratings 0 (no symptoms) to 5-symptoms so severe that par could not perform normal activity [morning] or to 4-symptoms so severe that par could not sleep at all [nightly]. Withdrawal due to poorly-controlled(WPC) (required step-up therapy) asthma was defined as asthma worsening/exacerbation or ≧3 per week of : day symptoms on ≧ 2 days, rescue use on ≧2 days, morning PEF <80 % of best effort on ≧ 1 day, night symptoms on ≧1 or more day, a best pre-bronchodilator forced expiratory volume in 1s (FEV1) < 80% at clinic . Percentage of par WPC asthma at visit 6, 7, 9 and 11 (Week 10, 12, 16 and 20 respectively) were reported. Cox Proportional Hazards Model was used with covariates of Baseline FEV1, gender, age and treatment group. Analysis was descriptive only, no p -values calculated, treatment differences and associated 95% CI were produced.|From Week 9 to Week 20|Intent-to-treat (ITT) population defined as participants randomized to treatment and who received at least one dose of randomized study medication in Period 2.|||Percentage of Participants||95% Confidence Interval|Number
2606969|NCT02094898|Secondary|CGI-S Score, Percentage Change From Baseline at Last Acute Phase Observation|The Clinical Global Impression Severity Subscale is an observer rated scale that measures illness severity. It has a range of responses from 1 (normal) through to 7 (among the most extremely ill patients).|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||percentage change in score||Standard Deviation|Mean
2606970|NCT02094898|Secondary|Clinical Global Impression-severity Subscale (CGI-S) at Baseline and Last Acute Phase Observation|The Clinical Global Impression Severity Subscale is an observer rated scale that measures illness severity. It has a range of responses from 1 (normal) through to 7 (among the most extremely ill patients).|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||units on a scale||Standard Deviation|Mean
2606971|NCT02094898|Secondary|MADRS Suicide (Item 10) Score, Percentage Change From Baseline at Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Item 10 scores can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide.)|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||percentage change in score||Standard Deviation|Mean
2606972|NCT02094898|Secondary|MADRS Suicide Thoughts (Item 10) Score at Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Item 10 scores can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide.)|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||units on a scale||Standard Deviation|Mean
2606973|NCT02094898|Secondary|MADRS Factor 4 Score, Percentage Change From Baseline at Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 4 (neurovegetative symptoms) consisted of MADRS items 3-5 (Inner Tension, Reduced Sleep, and Reduced Appetite). The MADRS Factor 4 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||percentage change in score||Standard Deviation|Mean
2606974|NCT02094898|Secondary|MADRS Factor 4 Score at Baseline and Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 4 (Neurovegetative Symptoms) consisted of MADRS items 3-5 (Inner Tension, Reduced Sleep, and Reduced Appetite). The MADRS Factor 4 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion|||units on a scale||Standard Deviation|Mean
2606975|NCT02094898|Secondary|MADRS Factor 3 Score, Percentage Change From Baseline at Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 3 (detachment) consisted of MADRS items 6 - 8 (Concentration Difficulties, Lassitude, and Inability to Feel). The MADRS Factor 3 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||percentage change in score||Standard Deviation|Mean
2606976|NCT02094898|Secondary|MADRS Factor 3 Score at Baseline and Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 3 (Detachment) consisted of MADRS items 6 - 8 (Concentration Difficulties, Lassitude, and Inability to Feel). The MADRS Factor 3 Score is derived by adding all the scores from the 3 items, meaning the lowest possible score is 0 and the highest possible is 18.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||units on a scale||Standard Deviation|Mean
2606977|NCT02094898|Secondary|MADRS Factor 2 Score, Percentage Change From Baseline at Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 2 (negative thoughts) consisted of MADRS items 9 (Pessimistic Thoughts) and 10 (Suicidal Thoughts). The MADRS Factor 2 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||percentage change in score||Standard Deviation|Mean
2606978|NCT02094898|Secondary|MADRS Factor 2 Score at Baseline and Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 2 (Negative Thoughts) consisted of MADRS items 9 (Pessimistic Thoughts) and 10 (Suicidal Thoughts). The MADRS Factor 2 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||units on a scale||Standard Deviation|Mean
2606979|NCT02094898|Secondary|MADRS Factor 1 Score, Percent Change From Baseline at Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 1 (Sadness) consisted of MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness). The MADRS Factor 1 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.|baseline, last acute phase observation|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||percentage change in score||Standard Deviation|Mean
2606980|NCT02094898|Secondary|MADRS Factor 1 Score at Baseline and Last Acute Phase Observation|The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. MADRS Factor 1 (Sadness) consisted of MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness). The MADRS Factor 1 Score is derived by adding all the scores from the 2 items, meaning the lowest possible score is 0 and the highest possible is 12.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||units on a scale||Standard Deviation|Mean
2606981|NCT02094898|Secondary|MADRS Total Score, Percent Change From Baseline at Last Acute Phase Observation|The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||percentage change in score||Standard Deviation|Mean
2606982|NCT02094898|Primary|MADRS Total Score at Baseline and Last Acute Phase Observation|The Montgomery Asberg Depression Scale (MADRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression.|baseline, last acute phase observation (approximately 2 weeks)|Statistical analyses included all subjects who received at least one acute-phase ketamine infusion.|||units on a scale||Standard Deviation|Mean
2606983|NCT02094885|Secondary|Percentage of Participants With Potential Bleeding-related Adverse Events|Percentage of participants with potential bleeding-related adverse events by study group|30-days follow-up||||percentage of participants||95% Confidence Interval|Number
2606984|NCT02094885|Secondary|Number of Participants Requiring Alternative Treatment Due to Treatment Failure*|Alternative treatments include the use of additional hemostatic methods, including collagen, manual compression, oxidized regenerated cellulose and suture. Manual compression (MC) may be applied after the initial 10 minute observation period as an alternative treatment due to treatment failure in either group. For participants with a treatment failure in MC group, the addition treatment of MC is applied after the initial 10 minute observation period.|Intra-operative, 10 minutes following randomization||||participants|||Number
2606985|NCT02094885|Secondary|Hemostasis at the Target Bleeding Site (TBS) at 3 and 6 Minutes Following the Completion of Treatment Application|Percentage of participants with Hemostasis at the TBS at 3 and 6 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.|Intra-operative, 3 and 6 minutes following randomization||||percentage of participants||95% Confidence Interval|Number
2606986|NCT02094885|Primary|Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following the Completion of Treatment Application.|Percentage of participants with Hemostasis at the TBS at 10 minutes following the completion of treatment application. Hempstasis is defined as absence of bleeding.|Intra-operative, 10 minutes following randomization||||percentage of patients||95% Confidence Interval|Number
2606987|NCT02094872|Secondary|Progression-Free Survival (PFS)|A log rank test will be performed for the comparison between the two groups.|From start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year|Given the lack of response in this study and the decision to terminate it early, no data for PFS data were collected or analyzed. In addition, with the study amendment removing the second arm, this analysis would not have been possible to conduct.||||||
2606988|NCT02094872|Primary|Best Overall Response Rate (BORR)|The best overall response rate (BORR) was assessed up to 1 year.|Up to 1 year||||Participants|||Count of Participants
2606989|NCT02094755|Primary|Asses the Prevalence of High On-treatment Platelet Reactivity in Critical Limb Ischemia Patients Treated With Aspirin and Clopidogrel.|Platelet inhibition to aspirin will be evaluated with the VerifyNow® aspirin (ASA) test. Clopidogrel platelet inhibition will be evaluated with two different tests: the vasodilator-stimulated phosphoprotein (VASP) and the VerifyNow® purinergic receptor P2Y12 (VN-P2Y12) assays.|Single measurment after a minimum of one week of uninterrupted dual antiplatelet therapy with aspirin and clopidogrel|"High on-treatment platelet reactivity on clopidigrel (HPRC) was defined as VerifyNow®P2Y12 reactive units (PRU) >208 and VASP-platelet reactivity index (VASP-PRI) >50%.~Thromboxane A2 (TXA2) inhibition was measured with the VerifyNow®aspirin test and High on-treatment reactivity on aspirin (HPRA) was defined as aspirin reaction units (ARU) >550."|||Participants|||Count of Participants
2606990|NCT02094677|Secondary|Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A|The ophthalmologist's objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion of filcon II 3 and nelfilcon A) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.|||units on a scale||Standard Deviation|Mean
2606991|NCT02094677|Secondary|Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A|The ophthalmologist's objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.|||units on a scale||Standard Deviation|Mean
2606992|NCT02094677|Secondary|Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A|"The ophthalmologist's objective assessment of corneal staining (extent) assessed at 6 hours by biomicroscopy (Grade as a % of each zone).~N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central"|6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.|||percentage of the area of each zone||Standard Deviation|Mean
2606993|NCT02094677|Secondary|Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A|"The ophthalmologist's objective assessment of corneal staining (extent) assessed at screening (before lens insertion) by biomicroscopy (Grade as a % of each zone).~N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central"|6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.|||percentage of the area of each zone||Standard Deviation|Mean
2606994|NCT02094677|Secondary|High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A|The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and nelfilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value)|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.|||logMAR||Standard Deviation|Mean
2606995|NCT02094677|Secondary|High Contrast Visual Acuity - Filcon II 3 and Etafilcon A|The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and etafilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.|||logMAR||Standard Deviation|Mean
2606996|NCT02094677|Secondary|Lens Surface Deposition - Filcon II 3 and Nelfilcon A|The ophthalmologist's objective assessment for lens surface deposition of filcon II 3 and nelfilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).|6 hour|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.|||units on a scale||Standard Deviation|Mean
2606997|NCT02094677|Secondary|Lens Surface Deposition - Filcon II 3 and Etafilcon A|The ophthalmologist's objective assessment for lens surface deposition of filcon II 3 and etafilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).|6 hour|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.|||units on a scale||Standard Deviation|Mean
2606998|NCT02094677|Secondary|Lens Fit, Tightness - Filcon II 3 and Nelfilcon A|The ophthalmologist's objective assessment for lens fit for tightness of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.|||percentage of tightness||Standard Deviation|Mean
2606999|NCT02094677|Secondary|Lens Fit, Tightness - Filcon II 3 and Etafilcon A|The ophthalmologist's objective assessment for lens fit for tightness of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.|||percentage of tightness||Standard Deviation|Mean
2607000|NCT02094677|Secondary|Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A|The ophthalmologist's objective assessment for lens fit for Post-Blink Movement of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.|||mm steps||Standard Deviation|Mean
2607001|NCT02094677|Secondary|Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A|The ophthalmologist's objective assessment for lens fit for Post-Blink Movement of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.|||mm steps||Standard Deviation|Mean
2607002|NCT02094677|Secondary|Lens Fit, Centration - Filcon II 3 and Nelfilcon A|The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior|After 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.|||participants|||Number
2607003|NCT02094677|Secondary|Lens Fit, Centration - Filcon II 3 and Nelfilcon A|The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at baseline) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior|Baseline|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.|||participants|||Number
2607004|NCT02094677|Secondary|Lens Fit, Centration - Filcon II 3 and Etafilcon A|The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior|6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.|||participants|||Number
2607005|NCT02094677|Secondary|Lens Fit, Centration - Filcon II 3 and Etafilcon A|"The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at baseline visit) by biomicroscopy (Optimum or Decentered N T S I).~N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior"|Baseline|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.|||participants|||Number
2607006|NCT02094677|Secondary|Lens Wettability - Filcon II 3 and Nelfilcon A|The ophthalmologist's objective assessment for lens wettability of filcon II 3 and nelficon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).|Baseline and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants.|||units on a scale||Standard Deviation|Mean
2607007|NCT02094677|Secondary|Lens Wettability - Filcon II 3 and Etafilcon A|The ophthalmologist's objective assessment for lens wettability of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).|Baseline and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants.|||units on a scale||Standard Deviation|Mean
2607008|NCT02094677|Secondary|Lens Handling (Removal) - Filcon II 3 and Nelfilcon A|Participant's subjective response for lens handling of filcon II 3 and nelfilcon A following removal (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).|6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.|||units on a scale||Standard Deviation|Mean
2607009|NCT02094677|Secondary|Lens Handling (Removal) - Filcon II 3 and Etafilcon A|Participant's subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).|6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.|||units on a scale||Standard Deviation|Mean
2607010|NCT02094677|Secondary|Lens Handling - Filcon II 3 and Nelfilcon A|Participant's subjective response for lens handling of filcon II 3 and nelfilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).|Baseline visit|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.|||units on a scale||Standard Deviation|Mean
2608789|NCT02074059|Primary|Peri-Dosing Events|Pre-specified adverse events that occured during treatment administration; does not include nCPAP alone|Within 48 Hours after Initiation of Study Treatment|Safety Population|||participants|||Number
2607011|NCT02094677|Secondary|Lens Handling - Filcon II 3 and Etafilcon A|Participant's subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle causes pain, 100=very easy to handle).|Baseline visit|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.|||units on a scale||Standard Deviation|Mean
2607012|NCT02094677|Secondary|Lens Dryness - Filcon II 3 and Nelfilcon A|Participant's subjective response for lens dryness of filcon II 3 and nelfilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced).|3 hours and 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.|||units on a scale||Standard Deviation|Mean
2607013|NCT02094677|Secondary|Lens Dryness - Filcon II 3 and Etafilcon A|Participant's subjective response for lens dryness of filcon II 3 and etafilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry 100=no dryness experienced).|3 hours and 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.|||units on a scale||Standard Deviation|Mean
2607014|NCT02094677|Secondary|Lens Comfort - Filcon II 3 and Nelficon A|Participant's subjective response for lens comfort of filcon II 3 and nelfilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).|Baseline, 3 hours, 6 hours|These results are between the filcon II 3 and nelfilcon A group which comprises of 30 participants. Habitual data collected before study lens dispensed.|||units on a scale||Standard Deviation|Mean
2607015|NCT02094677|Secondary|Lens Comfort - Filcon II 3 and Etafilcon A|Participant's subjective response for lens comfort of filcon II 3 and etafilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).|Baseline, 3 hours, 6 hours|These results are between the filcon II 3 and etafilcon A group which comprises of 40 participants. Habitual data collected before study lens dispensed.|||units on a scale||Standard Deviation|Mean
2607016|NCT02094677|Primary|Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A|Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 6 hours lens wear rated by questionnaire (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).|6 hours||||participants|||Number
2607017|NCT02094677|Primary|Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A|Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 3 hours lens wear rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).|3 hours||||participants|||Number
2607018|NCT02094677|Primary|Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A|"Participant's subjective response for lens preference of filcon II 3 and etafilcon A or filcon II 3 and nelfilcon A at baseline visit, following insertion, after settling 10-15mins (surveyed at baseline visit) rated by questionnaire.~(5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A)."|Baseline visit||||participants|||Number
2607019|NCT02094664|Secondary|Duration of O2 Use|Duration on supplemental O2 was measured in hours.|Subjects will be followed for the duration of oxygen requirement until oxygen discontinued||||hours||Standard Deviation|Mean
2607020|NCT02094664|Secondary|Length of Hospital Stay|Length of hospital stay is measured in days and counted from day of admission to day of discharge.|Subjects will be followed for the duration of hospital stay until discharge||||days||Standard Deviation|Mean
2607021|NCT02094664|Primary|Change in Respiratory Rate (RR) From Baseline|Respiratory rate was measured by counting respirations for one minute. Reported are the absolute scores at each time point, for each arm. Baseline scores are reported in the Baseline Module.|Baseline, Hour 1, Hour 4, Hour 8, and Hour 12||||breaths per minute||Standard Deviation|Mean
2607022|NCT02094664|Primary|Change in Respiratory Distress Assessment Instrument (RDAI) From Baseline.|The RDAI is a validated clinical scoring system to assess respiratory distress and has been used in several bronchiolitis studies. The RDAI is based on two variables, wheezing and retractions, in which points are applied to each to give a score ranging from 0 to 17. The higher the total score, the worse the subject was clinically. Reported are the absolute scores at each time point, for each arm. Baseline scores are reported in the Baseline Module.|Baseline, Hour 1, Hour 4, Hour 8, and Hour 12||||units on a scale||Standard Deviation|Mean
2607023|NCT02094612|Secondary|Other Health Services Use|"Update: Outcome measure reported is number of psychiatric and ED visits during the 6 month follow up period.~Use of healthcare services outside of pediatrics, including the emergency room and psychiatric services."|Baseline to six months||||visits|||Number
2607024|NCT02094612|Secondary|Satisfaction With Care|"Update: Outcome measure reported is number of participants who responded very satisfied with their ADHD care on 5-point Likert scale.~Likert scale single item measure of how satisfied the pediatric patient's parent was with care received"|Six months||||Participants|||Count of Participants
2607025|NCT02094612|Secondary|Medication Adherence|"Update: Outcome reported is number of participants taking medication as prescribed at all study follow up visits.~Sustained use of ADHD medication"|Baseline to six months||||Participants|||Count of Participants
2607026|NCT02094612|Secondary|Persistence in Care|"Update: Outcome measure reported is the # of participants who attended all study follow-up visits.~Use of pediatric health care services"|Baseline to Six Months||||Participants|||Count of Participants
2607027|NCT02094612|Secondary|Academic Performance|Academic performance will be measured by student report cards, and converted to a standardized scale|Baseline and Six Months|Academic performance was not measured, as there were a very low number of report cards collected (11 of 25 in Quotient arm and 16 of 33 in UC arm).||||||
2607089|NCT02093897|Secondary|Incremental Recovery|Incremental recovery expressed as (IU/dL)/(IU/kg) corrected for subject's predose plasma FVIII activity measured using the chromogenic substrate assay.|At 1 hour after the start of infusion|PK Population|||(IU/dL)/(IU/kg)||Standard Deviation|Mean
2607028|NCT02094612|Secondary|ADHD Symptomatology|"Outcomes reported are average SNAP IV scores at baseline and 6 monhts. ADHD symptomatology is measured by the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), developed by James Swanson, Edith Nolan and William Pelham. We used the 18-item self-report inventory designed to measure attention deficit hyperactivity disorder (ADHD) symptoms in children and young adults. Each question measures the frequency of a variety of symptoms or behaviors.The subscales measure Inattention (9 items) and Hyperactivity/impulsivity (9 items), using 0-3 rating, 0=not at all, 1=just a little, 2=quite a bit, or 3=very much. Each 9-item subscale results in a score in range 0-27. The two subscale scores were averaged to create a single score for the 18-item SNAP."|6 months post baseline||||Score on a scale||Standard Deviation|Mean
2607029|NCT02094612|Primary|Number of Participants With 25% Reduction in SNAP Scores|Outcome measure reported is the number of participants with at least one 25% reduction in SNAP between visits. In treatment of ADHD, the therapeutic dose is defined as a 25% reduction in SNAP IV score between consecutive clinic visits. SNAP is itemized rating scale (Swanson, Nolan, and Pelham-IV Questionnaire) designed to measure ADHD symptoms and severity on a 4 point scale. It is based on DSM IV criteria, and is designed to measure attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) symptoms in children and young adults ages 6-18.|One month, 3 month and six month follow ups|Fifty eight (58) participants completed the study (i.e., had their 6 month follow up appointment) when the study was terminated.|||Participants|||Count of Participants
2607030|NCT02094573|Secondary|Patient-reported Symptoms Global Health Status/Quality of Life (QoL) Scores|"Patient-reported symptoms global health status/quality of life (QoL) scores were based on questions 29 and 30 of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ-C30). The first 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and last 2 questions on global health status/QoL scale are coded on 7-point scale (1=very poor to 7=excellent). Six single-item scales also are included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Raw scores for multi-item scales and single-item measures will be linearly transformed to obtain the score ranging from 0 to 100, where higher score represents a higher (better) level of functioning."|Up to 30 days after the last dose of study drug or up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Here, n represents number of participants who were evaluable at specific time point.|||unit on a scale||Standard Deviation|Mean
2607031|NCT02094573|Secondary|Pre-dose Brigatinib Plasma Concentration||Day 1 Cycle 1 pre-dose; Cycle 2 pre-dose and at multiple time points (up to 6-8 hours) post dose; Cycles 3, 4 and 5 pre-dose and at 1-8 hours post dose|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||ng/ml||Standard Deviation|Mean
2607032|NCT02094573|Secondary|Number of Participants Who Had at Least One Treatment-Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|From first dose of study drug up to 30 days following the last dose of study drug (up to 20 months)|Safety population included all participants who received at least one dose of study drug.|||participants|||Number
2607033|NCT02094573|Secondary|Overall Survival (OS)|OS is defined as the time interval from the date of the first dose of the study treatment until death due to any cause. Intracranial OS was calculated by Kaplan-Meier estimation.|Up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose.|||months||95% Confidence Interval|Median
2607034|NCT02094573|Secondary|Progression Free Survival (PFS)|PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression is objectively documented, or death due to any cause, whichever occurs first. Disease progression for target lesion: SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest) and SLD must also demonstrate an absolute increase of at least 5 mm or development of any new lesion. Disease progression for non-target lesion: Unequivocal progression of existing non-target lesions. (Subjective judgment by experienced reader).|Up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose.|||months||95% Confidence Interval|Median
2607035|NCT02094573|Secondary|Disease Control Rate|Disease control rate (DCR) is defined as the proportion of randomized participants who were confirmed to have achieved CR or PR or have a best overall response as stable disease (SD) for 6 weeks or more after initiation of the study drug. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).|Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered cycle) through 15 cycles and every 3 cycles thereafter until disease progression or up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose.|||percentage of participants||95% Confidence Interval|Number
2607036|NCT02094573|Secondary|Time on Treatment|Time on treatment is defined as the time from the first to the last dose of study drug. For participants who have not discontinued, time on treatment was censored as of the last dose of the study drug.|Up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|Safety population included all participants who received at least one dose of study drug.|||days||Standard Deviation|Mean
2608861|NCT02073162|Secondary|Number of Participants With Anastomotic Leak||Indexed hospital stay||||Participants|||Count of Participants
2607037|NCT02094573|Secondary|Duration of Response|Duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that the progressive disease is objectively documented or death. Patients without progressive disease or death were censored at the last valid response assessment. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters.|Up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Participants who had confirmed CR or PR were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2607038|NCT02094573|Secondary|Time to Response|Time to response is defined as the time interval from the date of the first dose of the study drug until the initial observation of CR or PR for participants with confirmed CR/PR. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters.|Up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Participants who had confirmed CR or PR were evaluable for this outcome measure.|||months||Full Range|Median
2607039|NCT02094573|Secondary|Intracranial CNS Progression Free Survival (PFS) in Participants With Active Brain Metastases|Intracranial CNS PFS as evaluated by IRC is defined as the time interval from the date of the first dose of the study drug until the first date at which intracranial CNS disease progression, an increase of 20% or more in the sum of diameters of intracranial CNS target lesions, unequivocal progression of non-target lesions, or the appearance of new lesions in the intracranial CNS, was objectively documented by a scan, or death due to any cause, whichever occurred first.|Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered cycle) through 15 cycles and every 3 cycles thereafter until disease progression or up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Participants with active brain metastases at baseline were evaluated for this outcome measure.|||months||95% Confidence Interval|Median
2607040|NCT02094573|Secondary|Confirmed Intracranial Central Nervous System Objective Response Rate (CNS ORR) in Participants With Only Non-measurable Active Brain Metastases|Confirmed intracranial CNS ORR is defined as the proportion of the participants with CR or PR in the intracranial CNS per modification of RECIST v1.1 as evaluated by IRC after the initiation of study drug. Confirmed responses were those that persisted on repeat imaging 4 weeks or more after initial response. CR for target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis). CR for non-target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters.|Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered cycle) through 15 cycles and every 3 cycles thereafter until disease progression or up to data cut-off date:29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Participants with only non-measurable active brain metastases at baseline were evaluated for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2607041|NCT02094573|Secondary|Confirmed Intracranial Central Nervous System Objective Response Rate (CNS ORR) in Participants With Measurable Active Brain Metastases|Confirmed intracranial CNS ORR is defined as the proportion of the participants with CR or PR in the intracranial CNS per modification of RECIST v1.1 as evaluated by IRC after the initiation of study drug. Confirmed responses were those that persisted on repeat imaging 4 weeks or more after initial response. CR for target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis). CR for non-target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters.|Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered cycle) through 15 cycles and every 3 cycles thereafter until disease progression or up to data cut-off date:29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose. Participants with measurable active brain metastases at baseline were evaluated for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2607042|NCT02094573|Secondary|Confirmed Objective Response Rate (ORR) as Assessed by Independent Review Committee (IRC)|ORR assessed by the IRC, is defined as the proportion of the participants with confirmed Clinical response (CR) or partial response (PR) according to RECIST v1.1 (confirmed ≥4 weeks after initial response), after the initiation of study treatment. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. The exact 2-sided 95% confidence interval was calculated.|Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered cycle) through 15 cycles and every 3 cycles thereafter until disease progression or up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|ITT Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose.|||percentage of participants||95% Confidence Interval|Number
2608862|NCT02073162|Secondary|Number of Participants With Sepsis||Indexed hospital stay||||Participants|||Count of Participants
2607043|NCT02094573|Primary|Confirmed Objective Response Rate (ORR) as Assessed by Investigator|ORR assessed by the investigator, is defined as proportion of the participants with confirmed Complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid tumors (RECIST) v1.1 (confirmed ≥4 weeks after initial response), after initiation of study treatment. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and norrmalization of tumor marker level. PR: at least 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. The exact 2-sided 97.5% confidence interval was calculated. The treatment regimen was considered to have achieved the primary objective when lower bound of the 97.5% confidence interval for ORR assessed by investigator is greater than 20%.|Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered cycle) through 15 cycles and every 3 cycles thereafter until disease progression or up to data cut-off date: 29 Feb 2016 (approximately up to 20 months)|Intention to Treat (ITT) Population included all participants who were randomized to each regimen regardless of whether they received study drug or adhered to the assigned dose.|||percentage of participants||97.5% Confidence Interval|Number
2607044|NCT02094534|Secondary|Mean Nighttime, Daytime, and Fasting Glucose Levels|Mean glucose levels (by continuous glucose monitoring (CGM)) in Type 1 diabetes patients treated with ORMD-0801, compared to the mean glucose levels (by continuous glucose monitoring) for patients treated with placebo.|last two days (day 6 and day 7, averaged)|Intent to treat (ITT) population; This measurement is reported for those subjects who had at least 80% of the CGM readings. This explains why there are two fewer subjects from the ITT population reported for this endpoint.|||mg/dL||Standard Deviation|Mean
2607045|NCT02094534|Primary|Change From Baseline in Total, Basal, and Bolus Exogenous Insulin Requirements|Change from baseline (Run-in Average) to treatment days 6 and 7 (average of day 6 and 7) in exogenous insulin requirements in patients treated with ORMD-0801 compared to patients treated with placebo.|Baseline:Run-In Average (run in days 1-7), and treatment (day 6 and day 7)|Intend-to-treat polpulation|||mg/dL||Standard Deviation|Mean
2607046|NCT02094443|Secondary|Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End|ALT is an enzyme found mostly in the cells of the liver and kidney. When the liver is damaged, ALT is released into the blood. This makes ALT a common test for liver damage, because higher ALT levels may indicate more liver damage. ALT upper limit of normal is commonly considered to be 40 international units per liter (IU/L), so abnormal ALT is above 40 IU/L.|Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
2607047|NCT02094443|Secondary|Percentage of Participants With End of Treatment Response (ETR)|ETR was defined as serum HCV RNA < LLOQ at treatment end (completed or prematurely discontinued).|Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
2607048|NCT02094443|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|eRVR was defined as serum HCV RNA < LLOQ after 4 weeks of treatment|4 weeks|Full Analysis Set|||percentage of participants|||Number
2607049|NCT02094443|Secondary|Percentage of Participants With Extended Rapid Virologic Response|Extended rapid virologic response (eRVR) was defined as serum HCV RNA < LLOQ after 2 weeks of treatment|2 weeks|Full Analysis Set|||percentage of participants|||Number
2607050|NCT02094443|Secondary|Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment|SVR is defined as HCV RNA less than the lower limit of quantification (LLOQ), i.e., <15 IU/mL, at 4 weeks (SVR4), 12 weeks (SVR12), and 24 weeks (SVR24) after treatment, respectively.|Up to 24 weeks posttreatment|Full Analysis Set|||percentage of participants|||Number
2607051|NCT02094443|Primary|Change From Baseline in Alanine Aminotransferase (ALT) at Week 12|ALT levels were assessed as part of clinical chemistry assessments throughout the study as a measure of biochemical liver recovery. A negative change from baseline indicates less liver damage.|Baseline, Week 12|Participants in the safety set with available data at the given time point|||U/L||Standard Deviation|Mean
2607052|NCT02094443|Primary|Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12|The change in log transformed Hepatitis-C Virus (HCV) Ribonucleic acid (RNA) from baseline to Week 12.|Baseline, Week 12|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
2607053|NCT02094352|Primary|Pain Reduction|Evidence of changes in NRS pain scores between baseline and six months post infusion|6 months post infusion|Study terminated early due to lack of enrollment. We did not analyze any data.||||||
2607054|NCT02094326|Secondary|Exposure Time of Methotrexate|methotrexate|6 years||||months||Standard Deviation|Mean
2607055|NCT02094326|Secondary|Percentage of Patients Who Receive Subcutaneous Methotrexate||6 years||||percentage of participants||95% Confidence Interval|Number
2607056|NCT02094326|Secondary|Percentage of Patients Who Require an Alternative DMARD Due to Lack of Efficacy, Defined as Primary or Secondary Failure According to the Rheumatologist In-charge of Treatment||6 years||||percentage of participants||95% Confidence Interval|Number
2607057|NCT02094326|Secondary|Percentage of Patients Who Experience Adverse Events While on Treatment With Synthetic DMARDs Which Forces Drug Withdrawal||6 years||||percentage of participants||95% Confidence Interval|Number
2607058|NCT02094326|Secondary|Percentage of Patients Who Present Adverse Events While on Treatment With Synthetic Disease-modifying Antirheumatic Drug (DMARDs) and Require a Dose Reduction of the Synthetic DMARD in Question||6 years||||percentage of participants||95% Confidence Interval|Number
2607059|NCT02094326|Primary|Percentage of Patients Who Present Adverse Events, Intolerance or Lack of Efficacy to Synthetic DMARDs That Causes a Change in Treatment Prescription When Used in Routine Clinical Practice||6 years||||percentage of participants||95% Confidence Interval|Number
2607060|NCT02094300|Primary|Number of Patients With Major Complications|Major complication is defined as: Retrograde dissection, cardiac events requiring surgical management, prolonged ventilation requiring tracheotomy, renal failure requiring dialysis (where not previously needed), aortic fistula, mesenteric ischemia requiring surgical management, paralysis or paraparesis unresolved after 30 days of therapy, pulmonary embolism, stroke, and multi-system organ failure, unless related to presenting condition.|30 days|There were 8 patients experienced 30-day major complications.|||participants|||Number
2608863|NCT02073162|Secondary|Number of Participants With Surgical-site Infection||Indexed hospital stay||||Participants|||Count of Participants
2607061|NCT02094261|Secondary|Progression-Free Survival (PFS)|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of first dose until the date of PD (by independent review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from AZD9291 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.|RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)|All patients who received at least 1 dose of study treatment.|||months||95% Confidence Interval|Median
2607062|NCT02094261|Secondary|Disease Control Rate (DCR)|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. DCR is the percentage of patients with best response of CR, PR or SD (according to independent review), prior to progression (PD) or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)|All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.|||% of participants||95% Confidence Interval|Number
2607063|NCT02094261|Secondary|Duration of Response (DoR)|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR was defined as the time from the date of first documented response (CR or PR that was subsequently confirmed) until the date of documented progression (PD) or death in the absence of disease progression (by investigator assessment).|RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)|All patients who received at least 1 dose of study treatment, had measurable disease at baseline according to the independent review of baseline imaging data and had confirmed response.|||months||Full Range|Median
2607064|NCT02094261|Primary|Objective Response Rate (ORR)|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from first dose until objective disease progression, up to approximately 11 months (at the time of analysis)|All patients who received at least 1 dose of study treatment and had measurable disease at baseline according to the independent review of baseline imaging data.|||% of participants||95% Confidence Interval|Number
2607065|NCT02093962|Primary|Overall Survival|To assess the efficacy of pemetrexed in combination with TH-302 as determined by overall survival in patients with advanced non-squamous NSCLC in the second-line chemotherapy setting compared with pemetrexed in combination with placebo|2 years||||Participants|||Count of Participants
2607066|NCT02093949|Secondary|Spontaneous AF at the Beginning of the Procedure|Spontaneous AF at the beginning of the procedure|baseline||||Participants|||Count of Participants
2607067|NCT02093949|Secondary|Mean LA Volume|Left Atrial volume before ablation in ml|baseline||||ml||Standard Deviation|Mean
2607068|NCT02093949|Secondary|Maximum Sustained AF Duration|duration of the longest AF epiodes in months before ablation|from first AF episode to baseline||||months|||Number
2607069|NCT02093949|Secondary|Number of Patients With Major Adverse Events During and up to 18 Months After Procedure|Adverse events|18 months post ablation|"Group Substrate ablation long term follow-up n= 96/105: 9 patients (8.6%) did not complete the follow up; 1 patient died (myocardial infarction) and 8 were lost because of relocation.~Historical control long term follow-up group n=44/47: 3 patients dropped out during the blanking period (1 died of heart failure and 2 relocated)"|||participants|||Number
2607070|NCT02093949|Secondary|Percentage of Patients Free From Atrial Fibrillation 18 Months Post Ablation|% of patients in sinus rhythm or in atrial tachycardia assessed by ECG and/ot 24h-Holter monitoring and clinical examination during follow-up.|18 Months post ablation|"Group Substrate ablation long term follow-up n= 96/105: 9 patients (8.6%) did not complete the follow up; 1 patient died (myocardial infarction) and 8 were lost because of relocation.~Historical control long term follow-up group n=44/47: 3 patients dropped out during the blanking period (1 died of heart failure and 2 relocated)"|||% of participants|||Number
2607071|NCT02093949|Secondary|Radiofrequency Time (Min)||up to 300 min||||min|||Number
2607072|NCT02093949|Secondary|% of Patients With Sinus Rhythm Conversion During the Procedure||180 min||||% of participants|||Number
2607073|NCT02093949|Primary|Percentage of Patient With Atrial Fibrillation Termination at the End of the Procedure|percentage of patient in sinus rhythm or in atrial tachycardia at the end of the procedure|up to 240 min||||Percentage of participants|||Number
2607074|NCT02093923|Other Pre-specified|HAE Attack Rate Per Week|The pre-specified, primary efficacy analysis was based on subjects in the 300 mg, 400 mg, and placebo dose groups with a historical baseline attack rate of at least 2 attacks over the last 3 months prior to enrollment. The result is based on General Estimating Equation (GEE) analysis of repeated counts per week during the prespecified assessment period (Days 8 to 50; predicted to correspond to a period of notable drug exposure). Baseline HAE attack rate per week is a covariate, treatment group is a fixed effect, and subject is a random effect in the GEE model with independence working correlation structure.|Baseline, Day 8 to Day 50|Only subjects who had a baseline attack rate of at least 2 attacks in the last 3 months prior to enrollment are included.|||attacks/week||Standard Error|Mean
2607075|NCT02093923|Secondary|Terminal Elimination Half-life (t1/2)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.|||days||Standard Deviation|Mean
2607076|NCT02093923|Secondary|Apparent Volume of Distribution (Vd/F)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.|||liters||Standard Deviation|Mean
2607077|NCT02093923|Secondary|Apparent Clearance (CL/F)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.|||liters/day||Standard Deviation|Mean
2607078|NCT02093923|Secondary|Area Under the Plasma Concentration-time Curve (AUC)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.|||day*ng/mL||Standard Deviation|Mean
2607079|NCT02093923|Secondary|Time to Maximum Plasma Concentration (Tmax)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.|||days||Standard Deviation|Mean
2607080|NCT02093923|Secondary|Maximum Plasma Concentration (Cmax)||Pharmacokinetic samples were drawn on Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120.|All randomized HAE subjects who received at least 1 dose of DX-2930 and who have sufficient blood samples for pharmacokinetic analyses. Results from placebo-treated subjects were not analyzed for summary statistics since these subjects did not have detectable drug levels.|||ng/mL||Standard Deviation|Mean
2607081|NCT02093923|Primary|Proportion of Patients With Serious Adverse Events|"As per the DX-2930-02 clinical protocol, a SAE was any adverse experience occurring at any dose that resulted in any of the following outcomes:~Death~Life-threatening experience: life-threatening referred to a situation in which the subject was at risk of death at the time of the event, it did not refer to an event that might have caused death if it were more severe.~Required inpatient hospitalization or prolongation of existing hospitalization: this did not include hospitalization for observation with release within 24 hours. A scheduled hospitalization for a pre-existing condition that had not worsened during participation in the study did not meet this criterion. Pre-planned hospitalizations for an elective medical/surgical procedure or routine check-ups did not meet this criterion.~Resulted in persistent or significant disability or incapacity.~Was a congenital anomaly or birth defect.~Was considered to be an important medical event"|through 4 months|All randomized subjects who received at least 1 dose of study drug. The outcome measure data is presented as proportion (percentage) of participants with serious adverse events.|||percentage of participants|||Number
2607082|NCT02093923|Primary|Number of Patients With Serious Adverse Events (SAEs)|"As per the DX-2930-02 clinical protocol, a SAE was any adverse experience occurring at any dose that resulted in any of the following outcomes:~Death~Life-threatening experience: life-threatening referred to a situation in which the subject was at risk of death at the time of the event, it did not refer to an event that might have caused death if it were more severe.~Required inpatient hospitalization or prolongation of existing hospitalization: this did not include hospitalization for observation with release within 24 hours. A scheduled hospitalization for a pre-existing condition that had not worsened during participation in the study did not meet this criterion. Pre-planned hospitalizations for an elective medical/surgical procedure or routine check-ups did not meet this criterion.~Resulted in persistent or significant disability or incapacity.~Was a congenital anomaly or birth defect.~Was considered to be an important medical event"|through 4 months|All randomized subjects who received at least 1 dose of study drug. The outcome measure data is presented as number of participants with serious adverse events|||participants|||Number
2607083|NCT02093923|Primary|Proportion of Patients With Treatment-Emergent Adverse Events (TEAE)|As per the DX-2930-02 clinical protocol, an AE was considered treatment-emergent if the onset time was after administration of study drug through the Day 120 post-dose final follow-up visit or, in the event that onset time preceded study drug administration, the AE increased in severity during the 120-day post-dose follow-up period.|through 4 months|All randomized subjects who received at least 1 dose of study drug. The outcome measure data is presented as proportion (percentage) of participants with Treatment-Emergent Adverse Events (TEAE)|||percentage of participants|||Number
2607084|NCT02093923|Primary|Number of Patients With Treatment-Emergent Adverse Events (TEAE)|As per the DX-2930-02 clinical protocol, an AE was considered treatment-emergent if the onset time was after administration of study drug through the Day 120 post-dose final follow-up visit or, in the event that onset time preceded study drug administration, the AE increased in severity during the 120-day post-dose follow-up period.|through 4 months|All randomized subjects who received at least 1 dose of study drug. The outcome measure data is presented as number of participants with Treatment-Emergent Adverse Events (TEAE).|||participants|||Number
2607085|NCT02093897|Secondary|Number of Subjects With Inhibitor Formation to rVIII-SingleChain|The number of subjects who develop inhibitors to rVIII-SingleChain, defined as a rVIII-SingleChain antibody titer of at least 0.6 Bethesda Units (BU) per mL after receiving study drug.|At screening, then after dosing at approximately monthly intervals for 6 months, then every 3 months until reaching 50 EDs, and at the end of study visit (up to approximately 12 months).||||participants|||Number
2607086|NCT02093897|Secondary|Clearance (Cl) of rVIII-SingleChain|Clearance (Cl) of rVIII-SingleChain, baseline uncorrected; plasma FVIII activity measured using the chromogenic substrate assay.|Immediately before dosing, and at approximately 1, 5, 10, 24, and 48 hours after dosing.|PK Population|||mL/h/kg||Standard Deviation|Mean
2607092|NCT02093897|Secondary|Consumption of rVIII-SingleChain - IU/kg Per Bleeding Event||Up to 1 year|The Efficacy Population comprised all subjects who received at least 1 rVIII-SingleChain dose for prophylaxis or on-demand treatment. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).|||IU/kg per event||Full Range|Median
2607093|NCT02093897|Secondary|Consumption of rVIII-SingleChain - IU/kg Per Subject Per Year||Up to 1 year|The Efficacy Population comprised all subjects who received at least 1 rVIII-SingleChain dose for prophylaxis or on-demand treatment. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).|||IU/kg per subject per year||Full Range|Median
2607094|NCT02093897|Secondary|Consumption of rVIII-SingleChain - IU/kg Per Subject Per Month||Up to 1 year|The Efficacy Population comprised all subjects who received at least 1 rVIII-SingleChain dose for prophylaxis or on-demand treatment. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).|||IU/kg per subject per month||Full Range|Median
2607095|NCT02093897|Secondary|Percentage of Bleeding Episodes Requiring 1, 2, 3, or More Than 3 Infusions of rVIII-SingleChain to Achieve Hemostasis.||Up to 1 year|Efficacy Population|||Percentage (%) of bleeding episodes|Number of Treated Bleeds||Number
2607096|NCT02093897|Secondary|Annualized Bleeding Rate|The annualized bleeding rate was defined as the number of bleeding episodes requiring treatment divided by the efficacy evaluation period in days, x 365.25, and is presented separately for the on-demand regimen and the prophylaxis regimens.|Up to 1 year|The Efficacy Population comprised all subjects who received at least 1 rVIII-SingleChain dose for prophylaxis or on-demand treatment. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).|||Treated bleeding episodes per year||Inter-Quartile Range|Median
2607097|NCT02093897|Primary|Treatment Success|"Rate of treatment success where treatment success of a bleeding episode is defined as a rating of excellent or good based on the investigator's overall clinical assessment of hemostatic efficacy (using a 4-point scale of excellent, good, moderate or poor/no response) on the on-demand and prophylaxis regimens combined. The rate of success was based on the number of treated bleeding events; there were 347 treated bleeding events in the Efficacy Population."|Up to 1 year|Efficacy Population|||Percentage of treated bleeding events|Treated bleeding events|95% Confidence Interval|Number
2607098|NCT02093819|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)|2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration|The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2607099|NCT02093819|Secondary|Cmax (Maximum Measured Concentration of the Analyte in Plasma)|Cmax (maximum measured concentration of the analyte in plasma)|2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration|The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2607100|NCT02093819|Primary|Percentage of Subjects With Drug-related Adverse Events|Percentage of subjects with drug-related adverse events|AEs were recorded throughout the trial|The PKS included 59 subjects of the TS who provided at least 1 value of the endpoints Cmax, AUC0-∞, or AUC0-tz.|||percentage of participants|||Number
2607101|NCT02093702|Secondary|Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Resistance Exercise Recommendations|The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 2 sessions per week of resistance exercise.|Baseline and 12 months||||sessions/week||Full Range|Mean
2607102|NCT02093702|Secondary|Mean Change in Adherence to the Canadian Diabetes Association's Clinical Practice Guidelines Aerobic Exercise Recommendations|The Canadian Diabetes Association's Clinical Practice Guidelines recommends at least 150 minutes per week of aerobic exercise.|Baseline and 12 months||||minutes/week||Full Range|Mean
2607103|NCT02093702|Primary|Mean Change in Diastolic Blood Pressure||Baseline and 12 months||||mm Hg||Full Range|Mean
2607104|NCT02093702|Primary|Mean Change in Total Cholesterol: HDL-C Ratio||Baseline and 12 months||||mmol/L:mmol/L||Full Range|Mean
2607105|NCT02093702|Primary|Mean Change in Triglycerides (TGs)||Baseline and 12 months||||mmol/L||Full Range|Mean
2607106|NCT02093702|Primary|Mean Change in LDL-C||Baseline and 12 months||||mmol/L||Full Range|Mean
2607107|NCT02093702|Primary|Mean Change in HDL-C||Baseline and 12 months||||mmol/L||Full Range|Mean
2607108|NCT02093702|Primary|Mean Change in Serum Total Cholesterol||Baseline and 12 months||||mmol/L||Full Range|Mean
2607109|NCT02093702|Primary|Mean Change in Body Mass Index||Baseline and 12 months||||kg/m^2||Full Range|Mean
2607110|NCT02093702|Primary|Mean Change in Waist Circumference||Baseline and 12 months||||cm||Full Range|Mean
2607111|NCT02093702|Primary|Mean Change in Systolic Blood Pressure||Baseline and 12 months||||mm Hg||Full Range|Mean
2607112|NCT02093702|Primary|Mean Change in Hemoglobin A1c (HbA1c) Levels||Baseline and 12 months||||mmol/mol||Full Range|Mean
2607113|NCT02093689|Primary|Change in Pupil Diameter|Change in pupil diameter over time from surgical baseline to the end of the surgical procedure determined by video capture during ILR.|Intraoperative|Pupil measurement methodology determined not to be appropriate in this population and data were not analyzed from any participant.||||||
2607151|NCT02093351|Primary|Effect of Olaparib on Exposure to Letrozole - Cmax ss|Letrozole Cmax ss in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios|Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 38 and Day 43|PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2607114|NCT02093663|Secondary|Number of Participants With Remission at Pediatric Ulcerative Colitis Activity Index (PUCAI) Score During Double-Blind Maintenance Phase at Week 26|PUCAI was a physician-administered measure that focuses on 6 key signs and symptoms of UC and activity limitations producing a total score ranging from 0-85 with higher scores being worse. Recommended cut-off scores to differentiate disease activity are < 10 (remission); 11-30 (mild); 31-64 (moderate) and > 65 (severe). Number of participants with remission at PUCAI score during double-blind maintenance phase at week 26 were reported.|Week 26|Double-blind maintenance phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind maintenance phase.|||Participants|||Count of Participants
2607115|NCT02093663|Secondary|Change From Baseline in Daily Ulcerative Colitis Scale (DUCS) Score During Double-Blind Maintenance Phase|DUCS score was to measure 7 specific signs or symptom and one impact (abdominal pain, nocturnal stool, daytime stool, blood in stool, diarrhea, urgency, tiredness) of UC with each score range from 0 (worst) to 10 (best) with the overall score ranging from 0 (worst) to 70 (best) based on the responses. Change from Baseline in DUCS score during double-blind maintenance phase at week 13 and Week 26 wwere reported.|Baseline, Week 13, and Week 26|Double-blind maintenance phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind maintenance phase. Here, number of participants analyzed signifies participants who were evaluable for this measure category.|||Score on the scale||Standard Error|Mean
2607116|NCT02093663|Secondary|Number of Participants With Clinical and Endoscopic Response During Double-Blind Maintenance Phase at Week 26 Using Local Reading|Clinical and endoscopic response was defined as UC-DAI < or = 2 with rectal bleeding=0, stool frequency < or = 1, PGA=0, and with mucosal healing (endoscopy score < or = 1) based on local reading. Number of participants who had maintained clinical and endoscopic response during double-blind maintenance phase at week 26 using local reading were reported.|Week 26|Double-blind maintenance phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind maintenance phase.|||Participants|||Count of Participants
2607117|NCT02093663|Secondary|Number of Participants With Clinical and Endoscopic Response During Double-Blind Maintenance Phase at Week 26 Using Central Reading|Clinical and endoscopic response was defined as UC-DAI < or =2 with rectal bleeding=0, stool frequency < or =1, PGA=0, and with mucosal healing (endoscopy score < or =1) based on central reading at Week 26. Number of participants with clinical and endoscopic response during double-blind maintenance phase at Week 26 using central reading were reported.|Week 26|Double-blind maintenance phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind maintenance phase.|||Participants|||Count of Participants
2607118|NCT02093663|Secondary|Number of Participants With Improvement in Pediatric Ulcerative Colitis Activity Index (PUCAI) Score During Double-blind Acute Phase at Week 8|PUCAI was a physician-administered measure that focuses on 6 key signs and symptoms of UC and activity limitations producing a total score ranging from 0-85 with higher scores being worse. Recommended cut-off scores to differentiate disease activity are < 10 (remission); 11-30 (mild); 31-64 (moderate) and > 65 (severe). Participants with an improvement (change of greater than or equal to [> or =] 20 points) in PUCAI score. Number of participants with improvement in PUCAI score during Double-blind Acute Phase at Week 8 were reported.|Week 8|Double-blind acute phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind acute phase.|||Participants|||Count of Participants
2607119|NCT02093663|Secondary|Change From Baseline in Daily Ulcerative Colitis Scale (DUCS) Score During Double-Blind Acute Phase|DUCS score was to measure 7 specific signs or symptom and one impact (abdominal pain, nocturnal stool, daytime stool, blood in stool, diarrhea, urgency, tiredness) of UC with each item score ranged from 0 (worst) to 10 (best) with the overall score ranged from 0 (worst) to 70 (best) based on the responses. Change in the DUCS score from baseline to Week 8 during DBA phase were reported.|Baseline to Week 8|Double-blind acute phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind acute phase. Here, number of participants analyzed signifies participants who were evaluable for this measure category.|||Score on the scale||Standard Error|Mean
2607120|NCT02093663|Secondary|Number of Participants With Clinical and Endoscopic Response During Double Blind Acute Phase at Week 8 Using Local Reading|Clinical and endoscopic response was defined as UC-DAI < or =2 with rectal bleeding = 0 and stool frequency < or =1, and PGA = 0, and with mucosal healing (endoscopy score < or =1) at least a 1 point reduction in endoscopy score from baseline based on local reading. Participants with missing data at week 8 were assumed not to had a clinical response. Participants who completed week 8 but did not have local reading endoscopies at both baseline and week 8 were excluded. Number of participants with clinical and endoscopic response were reported.|Week 8|Double-blind acute phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind acute phase.|||Participants|||Count of Participants
2607121|NCT02093663|Secondary|Number of Participants With Clinical and Endoscopic Response During Double Blind Acute Phase at Week 8 Using Central Reading|Clinical and endoscopic response was defined as UC-DAI <=2 with rectal bleeding = 0 and stool frequency <=1, and PGA = 0, and with mucosal healing (endoscopy score <=1) at least a 1 point reduction in endoscopy score from baseline based on central reading. Participants with missing data at week 8 were assumed not to had a clinical response. Participants who completed week 8 but did not have central reading endoscopies at both baseline and week 8 were excluded. Number of participants with clinical and endoscopic response were reported.|Week 8|Double-blind acute phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind acute phase.|||Participants|||Count of Participants
2607122|NCT02093663|Primary|Number of Participants With Clinical Response During Double-blind Maintenance Phase at Week 26|Clinical response was defined as partial UC-DAI <=1 with (rectal bleeding = 0, stool frequency < or =1, and PGA = 0). Number of participants who had maintained clinical response were reported.|Week 26|Double-blind maintenance phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind maintenance phase.|||Participants|||Count of Participants
2608864|NCT02073162|Secondary|Number of Participants With a Composite of Mortality or Major Septic Complications||30-day||||Participants|||Count of Participants
2607123|NCT02093663|Primary|Number of Participants With Clinical Response During Double-Blind Acute Phase at Week 8|Clinical response was defined as partial ulcerative colitis disease activity index (UC-DAI) score < or =1 with rectal bleeding = 0, stool frequency < or =1, and physician's global assessment (PGA = 0). Number of participants with clinical response were reported.|Week 8|Double-blind acute phase safety analysis set consisted of randomized participants who had taken at least 1 dose of investigational product during the double-blind acute phase.|||Participants|||Count of Participants
2607124|NCT02093520|Secondary|Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months|Proportion of ZCQ Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.|12 months|Six participants in the MILD and 22 in the ESI group did not receive study treatment, therefore 143/149 MILD participants and 129/153 ESI participants were analyzed for outcome.|||Participants|||Count of Participants
2607125|NCT02093520|Secondary|Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months|Proportion of NPRS Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.|12 months|Six participants in the MILD and 22 in the ESI group did not receive study treatment, therefore 143/149 MILD participants and 129/153 ESI participants were analyzed for outcome.|||Participants|||Count of Participants
2607126|NCT02093520|Primary|Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months|Proportion of ODI Responders from baseline to one year follow-up in the treatment group versus the proportion of ODI Responders from baseline to one year follow-up in the control group. ODI Responders are defined as those patients achieving the validated Minimal Important Change in ODI score from baseline to follow-up as a clinically significant efficacy threshold.|12 months|Six participants in the MILD and 22 in the ESI group did not receive study treatment, therefore 143/149 MILD participants and 129/153 ESI participants were analyzed for outcome.|||Participants|||Count of Participants
2607127|NCT02093390|Secondary|Plasma Trough Concentrations for Atorvastatin|Blood samples for atorvastatin trough levels were collected predose (before dosing with atorvastatin and before breakfast) on Days 8 through 12.|Days 8 to 12 Predose|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||ng/mL||Standard Deviation|Mean
2607128|NCT02093390|Secondary|Plasma Trough Concentrations for Fluconazole|Blood samples for fluconazole trough levels were collected predose (before dosing with fluconazole and before breakfast) on Days 8 through 12.|Days 8 to 12 Predose|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||ng/mL||Standard Deviation|Mean
2607129|NCT02093390|Secondary|Fraction Excreted Unchanged (Fe) of TAK-385|Fraction of TAK-385 excreted in the urine unchanged.|Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||percent of TAK-385||Standard Deviation|Mean
2607130|NCT02093390|Secondary|Apparent Total Body Clearance (CL/F) of TAK-385||Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||liters/hour||Standard Deviation|Mean
2607131|NCT02093390|Secondary|Terminal Disposition Half-life (t1/2) of TAK-385|Terminal disposition half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||hours||Standard Deviation|Mean
2607132|NCT02093390|Secondary|AUC (0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours of TAK-385|Area under the plasma concentration versus time curve from 0 to 120 hours after study drug administration.|Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||ng*hr/mL||Standard Deviation|Mean
2607133|NCT02093390|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration of TAK-385|Tmax is the time to reach the maximum concentrations (Cmax), equal to time (hours) to Cmax.|Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||hours||Full Range|Median
2607134|NCT02093390|Secondary|Number of Participants With Clinical Significant Changes in Laboratory Tests|Blood samples were collected for analysis of clinical chemistry and hematological parameters and urine samples were obtained for urinalysis. Clinical laboratory evaluations were performed at central and /local laboratories.|Baseline and First dose of study drug through the end of the study (22 days ± 3 days)|Safety population included all randomized participants with at least one dose of study drug.|||participants|||Number
2607135|NCT02093390|Secondary|Number of Participants With Clinical Significant Changes in Electrocardiogram (ECG) Findings|A 12-lead ECG was administered on Days 1,9,10,11,15.|Baseline and First dose of study drug through Day 15||||participants|||Number
2607136|NCT02093390|Secondary|Number of Participants With Clinical Significant Changes in Vital Signs|Vital sign measurements included oral temperature, heart rate, supine (after 3 to 5 minutes in this position) and standing (after 3 to 5 minutes in this position) measurements of diastolic and systolic blood pressure.|Baseline and First dose of study drug through the end of the study (22 days ± 3 days)|Safety population included all randomized participants with at least one dose of study drug.|||participants|||Number
2607152|NCT02093351|Primary|Effect of Anastrozole on Exposure to Olaparib - Cmax ss|Olaparib Cmax ss in the presence and absence of co-administered anastrozole, and associated Cmax ss treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 24|PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2608865|NCT02073162|Secondary|Number of Participants With Acute Kidney Injury||90 days||||Participants|||Count of Participants
2607137|NCT02093390|Secondary|Number of Participants With at Least 1 Treatment Emergent Adverse Event (AE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of study drug through the end of the study (22 days ± 3 days)|Safety population included all randomized participants with at least one dose of study drug.|||participants|||Number
2607138|NCT02093390|Primary|AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 10|Area under the plasma concentration-time curve from time 0 to infinity.|Day 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||ng*hr/mL||Standard Deviation|Mean
2607139|NCT02093390|Primary|AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 1|Area under the plasma concentration-time curve from time 0 to infinity.|Day 1 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||ng*hr/mL||Standard Deviation|Mean
2607140|NCT02093390|Primary|AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 10|Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration.|Day 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||ng*hr/mL||Standard Deviation|Mean
2607141|NCT02093390|Primary|AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 1|Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration.|Day 1 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||ng*hr/mL||Standard Deviation|Mean
2607142|NCT02093390|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 10|Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 10 (Predose and multiple time points up to 120 hours postdose)|PK-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||ng/mL||Standard Deviation|Mean
2607143|NCT02093390|Primary|Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 1|Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 (Predose and multiple time points up to 120 hours postdose)|Pharmacokinetic (PK)-Evaluable population included all enrolled participants who received at least one dose of study drug and had data available for analysis of the PK parameters.|||ng/mL||Standard Deviation|Mean
2607144|NCT02093351|Primary|Effect of Letrozole on Exposure to Olaparib - AUC0-τ|Olaparib AUC0-τ, in the presence and absence of co-administered letrozole, and associated AUC0-τ treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 43|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2607145|NCT02093351|Primary|Effect of Olaparib on Exposure to Letrozole - AUC0-τ|Letrozole AUC0-τ, in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios|Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 38 and Day 43|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2607146|NCT02093351|Primary|Effect of Anastrozole on Exposure to Olaparib - AUC0-τ|Olaparib AUC0-τ, in the presence and absence of co-administered anastrozole, and associated AUC0-τ treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 24|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2607147|NCT02093351|Primary|Effect of Olaparib on Exposure to Anastrozole - AUC0-τ|Anastrozole Area under plasma concentration-time curve over the dosing interval at steady state (AUC0-τ), in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios|Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 19 and Day 24|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2607148|NCT02093351|Primary|Effect of Tamoxifen on Exposure to Olaparib - AUC0-τ|Olaparib AUC0-τ, in the presence and absence of co-administered tamoxifen, and associated AUC0-τ treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 31|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2607149|NCT02093351|Primary|Effect of Olaparib on Exposure to Tamoxifen - AUC0-τ|Tamoxifen, N-DMT and endoxifen AUC0-τ, in the presence and absence of co-administered olaparib, and associated AUC0-τ treatment ratios|Pre-dose and at 1, 2, 4, 5, 6, 8, 12 and 24 hours post-dose on Day 26 and Day 31|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||microgram x hour/millilitre (mcg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2607150|NCT02093351|Primary|Effect of Letrozole on Exposure to Olaparib - Cmax ss|Olaparib Cmax ss in the presence and absence of co-administered letrozole, and associated Cmax ss treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 43|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2607153|NCT02093351|Primary|Effect of Olaparib on Exposure to Anastrozole - Cmax ss|Anastrozole maximum plasma concentration at steady state (Cmax ss) in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios|Pre-dose and at 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 19 and Day 24|PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||micrograms per millilitre (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2607154|NCT02093351|Primary|Effect of Tamoxifen on Exposure to Olaparib - Cmax ss|Olaparib Cmax ss in the presence and absence of co-administered tamoxifen, and associated Cmax ss treatment ratios|Pre-dose and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post morning dose on Day 5 and Day 31|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2607155|NCT02093351|Primary|Effect of Olaparib on Exposure to Tamoxifen - Cmax ss|Tamoxifen, N-desmethyl tamoxifen (N-DMT) and endoxifen Cmax ss in the presence and absence of co-administered olaparib, and associated Cmax ss treatment ratios|Pre-dose and at 1, 2, 4, 5, 6, 8, 12 and 24 hours post-dose on Day 26 and Day 31|The PK Analysis set included all patients who received a study drug dose and provided evaluable PK profiles for at least 1 treatment period in Part A.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2607156|NCT02093234|Secondary|Change in Medication Adherence|Medication adherence Improvement from baseline after 1 year as measured by the Morisky Medication Adherence Survey. Range 1-4 . 1= least adherent , 4= most adherent|baseline and 1 year||||units on a scale||Standard Deviation|Mean
2607157|NCT02093234|Secondary|Change in Hemoglobin A1C|Change in HbA1c after 1 year from baseline|Baseline and 1 year||||Percentage of total hemoglobin||Standard Error|Mean
2607158|NCT02093234|Secondary|Change in Distress From Baseline as Measured With Fisher Brief Diabetes Distress Screening Instrument|"Participants completed the Fisher Brief Diabetes Screening Instrument at baseline and after 1 year of intervention. The instrument consists of 4 questions regarding how participants feel about dealing with diabetes. They are answered using a scale that goes from 1-6, 1= not a bother and 6=very bothersome. Range 4-24.~Low distress < 12 : moderate / high distress > or = 12."|Baseline and 1 year||||units on a scale||Standard Error|Mean
2607159|NCT02093234|Primary|Change From Baseline in the Unmet Behaviors/Goals That Were Not Achieved at Year 1|The study staff will determine the status of the 13 behaviors/goals for the year prior to study enrollment. Our primary endpoint will be the mean change after 1 year in number of behaviors/goals met from baseline.|baseline and 1 year|Sample size estimates were based on the study hypotheses and the associated primary endpoint. Dropouts were analyzed using intention to treat methodology.|||incomplete behaviors/goals||Standard Error|Mean
2607160|NCT02093221|Secondary|Change From Baseline for Mean Daily Glucose Levels Prior to Meals and Bedtime|For each visit, the mean daily glucose levels were calculated over the previous 3-7 days prior to the study visit from blood glucose levels recorded daily prior to meals and bedtime.|Baseline, Weeks 2, 4, 14, 27, 39, 52, 69, 87, and 104|Forty-three subjects prematurely discontinued (prior to Week 104); 28 subjects were considered a premature discontinuation due to sponsor termination of the study.|||mmol/L||Standard Deviation|Mean
2607161|NCT02093221|Secondary|Change From Baseline for Mean Daily Insulin Dose Requirements||Baseline, Weeks 2, 4, 14, 27, 39, 52, 69, 87, and 104|Forty-three subjects prematurely discontinued (prior to Week 104); 28 subjects were considered a premature discontinuation due to sponsor termination of the study.|||U/kg/day||Standard Deviation|Mean
2607162|NCT02093221|Secondary|Number of Subjects With Overall Severe Hypoglycemic Episodes|Severe hypoglycemia defined according the ADA Workgroup on Hypoglycemia definition, as follows: An event requiring assistance of another person to actively administer carbohydrate, glucagons, or other resuscitative actions.|104 weeks|Forty-three subjects prematurely discontinued (prior to Week 104); 28 subjects were considered a premature discontinuation due to sponsor termination of the study.|||Participants|||Count of Participants
2607163|NCT02093221|Secondary|Change From Baseline for HbA1c Levels||Baseline, Weeks 14, 27, 39, 52, 69, 87, and 104|Forty-three subjects prematurely discontinued (prior to Week 104); 28 subjects were considered a premature discontinuation due to sponsor termination of the study.|||percentage of change from baseline||Standard Deviation|Mean
2607164|NCT02093221|Secondary|Change From Baseline for MMTT Stimulated C-peptide 2h AUC||Baseline, Weeks 14, 27, 39, 69, 87, and 104 (pre-high protein drink and 15, 30, 60, 90, 120 minutes post-drink)|Forty-three subjects prematurely discontinued (prior to Week 104); 28 subjects were considered a premature discontinuation due to sponsor termination of the study.|||min*nmol/L||Standard Deviation|Mean
2607165|NCT02093221|Primary|Change From Baseline in Mixed Meal Tolerance Test (MMTMT) Stimulated C-peptide 2 Hour Area Under the Concentration-time Curve (AUC)|"C-peptide concentration during MMTT with high protein energy drink. Dose for time frame refers to intake of high protein energy drink."|Baseline, Week 52 (pre-high protein drink and 15, 30, 60, 90, 120 minutes post-drink)|Twelve subjects prematurely discontinued from the study prior to Week 52.|||min*nmol/L||Standard Deviation|Mean
2607166|NCT02093026|Secondary|Time Since Last Treatment Course|Time since last treatment course = The last day of the last dose of rituximab to date of last contact. Date of last contact is the last available date of efficacy, complete medication start date, laboratory, adverse event assessments, early withdrawal visit, date of last contact, or date of death.|Baseline up to 10 years|ITT Population. Here, number of participants analyzed = participants who entered into safety follow-up.|||years||Standard Deviation|Mean
2607167|NCT02093026|Secondary|Percentage of Participants Who Discontinued Treatment Due to Insufficient Response||First, second, third, fourth, fifth, sixth, and seventh course of rituximab (up to a median of approximately 2, 62, 124, 186, 248, 310, and 372 weeks, respectively)|Safety Population. Number analyzed = participants who were evaluable for specified category.|||percentage of participants|||Number
2607168|NCT02093026|Secondary|Change From Baseline in Total Rheumatoid Factors (RF) at 24 Weeks Following Each Course||24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)|The data for this outcome measure was not analyzed as this outcome was removed per changes in the planned analysis. Per changes in the planned analysis, only key efficacy parameters were analyzed as the long-term efficacy of rituximab is well established.||||||
2607169|NCT02093026|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at 24 Weeks Following Each Course|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.|24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.|||units on a scale||Standard Deviation|Mean
2607170|NCT02093026|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'|DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and Physician's Global Assessment of Disease Activity (VAS: 0=no disease activity to 100=maximum disease activity). DAS28-ESR = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*Patient's Global Assessment of Disease Activity. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with a DAS28 score less than or equal to (≤) 3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 to less than or equal to (≤) 5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1.|24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.|||percentage of participants|||Number
2607171|NCT02093026|Secondary|Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR|DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (millimeters per hour [mm/hour]), and Patient's Global Assessment of Disease Activity (VAS: 0=no disease activity to 100=maximum disease activity). DAS28-ESR = 0.56*square root (sqrt)(TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*Patient's Global Assessment of Disease Activity. Total score range: 0-10, higher score=more disease activity. DAS28-ESR <= 3.2 implied low disease activity (LDA) and DAS28-ESR <2.6 = clinical remission.|24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.|||percentage of participants|||Number
2607172|NCT02093026|Secondary|American College of Rheumatology Index of Improvement (ACRn) Response|The ACRn is calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (patient's assessment of disease activity; patient's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value [either CRP or ESR]). The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA. ACRn scores were calculated considering the original baseline in the precursor studies WA16291 or WA17043.|24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.|||units on a scale||Standard Deviation|Mean
2607173|NCT02093026|Secondary|Percentage of Participants With ACR50 and ACR70 Response|A participant had an ACR50 and ACR70 response if there was at least a 50% or 70% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of disease activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (CRP or ESR). The ACR50 and ACR70 responses were compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.|||percentage of participants|||Number
2607174|NCT02093026|Primary|Percentage of Participants With ACR20 Response After Seventh Course|A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after seventh course of rituximab (median duration of 406.7 weeks)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
2607192|NCT02092662|Secondary|Handwriting Off-paper Time.|Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks. The time the pen is on air is measured. The data from the tablet passed to the computer to be processed by the software.|T1 at the beginning of the hospital stay and folloew up at T2 one mont...|||||||
2607193|NCT02092662|Secondary|Handwriting Pressure.|Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks, and the pressure exerted with the pen on the tablet is recorded. The data from the tablet passed to the computer to be processed by the software.|T1 at the beginning of the hospital stay and folloew up at T2 one mont...|||||||
2607175|NCT02093026|Primary|Percentage of Participants With ACR20 Response After Sixth Course|A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after sixth course of rituximab (median duration of 354.4 weeks)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
2607176|NCT02093026|Primary|Percentage of Participants With ACR20 Response After Fifth Course|A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after fifth course of rituximab (median duration of 297.3 weeks)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
2607177|NCT02093026|Primary|Percentage of Participants With ACR20 Response After Fourth Course|A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after fourth course of rituximab (median duration of 232 weeks)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
2607178|NCT02093026|Primary|Percentage of Participants With ACR20 Response After Third Course|A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after third course of rituximab (median duration of 162.9 weeks)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
2607179|NCT02093026|Primary|Percentage of Participants With ACR20 Response After Second Course|A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after second course of rituximab (median duration of 90.9 weeks)|ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
2607180|NCT02093026|Primary|Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response After First Course|A participant had an ACR20 response if there was at least a 20 percent (%) improvement, ie, reduction from Baseline, in tender joint count (TJC) and swollen joint count (SJC) (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0=no disease activity to 100=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0=no pain to 100=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either C-reactive protein [CRP] or erythrocyte sedimentation rate [ESR]). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.|24 weeks after first course of rituximab (up to approximately 26 weeks)|Intent to treat (ITT) Population included all participants who received any part of an infusion of study medication under Study WA16855. Here, number of participants analyzed = participants who were evaluable for this outcome.|||percentage of participants|||Number
2607194|NCT02092662|Secondary|% Maximum Voluntary Contraction.|T1 at the beginning of the hospital stay and folloew up at T2 one month later.|The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average.|||||||
2607245|NCT02092220|Secondary|Number of Participants With Severe Hypoglycemic Events|A severe hypoglycemic event is an event where the participant is unable to self-treat and requires the assistance of another person.|11 days of each period|All participants who completed both periods of the study.|||Participants|||Count of Participants
2607181|NCT02092961|Other Pre-specified|DAS-CRP Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition. ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, PO = orally, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
2607182|NCT02092961|Other Pre-specified|OMERACT RAMRIS Erosions Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)|OMERACT RAMRIS erosions score was based on 25 joints and ranged from 0 to 250 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.|||Units on a scale||Inter-Quartile Range|Median
2607183|NCT02092961|Other Pre-specified|Joint Space Narrowing - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)|Joint space narrowing score was based on 20 joints, scored from MRI images and ranged from 0 to 80 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, JSN = joint space narrowing, MRI = magnetic resonance imaging, PO = orally, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.|||Units on a scale||Inter-Quartile Range|Median
2607184|NCT02092961|Other Pre-specified|OMERACT RAMRIS Osteitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)|OMERACT RAMRIS osteitis score was based on 25 joints, scored from MRI images, and ranged from 0 to 75 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.|||Units on a scale||Inter-Quartile Range|Median
2607185|NCT02092961|Primary|OMERACT RAMRIS Synovitis Score - Comparison of Change From Baseline Between Fostamatinib and Placebo or Adalimumab (Van Elteren)|OMERACT RAMRIS synovitis score was based on 8 joints, scored from MRI images, and ranged from 0 to 24 with a smaller value indicating a better clinical condition. Median changes from baseline are shown at each visit (defined as post-baseline minus baseline) with negative values indicative of a better clinical condition. BID = twice daily, CI = confidence interval, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, MRI = magnetic resonance imaging, OMERACT = Outcome Measures in Rheumatoid Arthritis Clinical Trials, PO = orally, RAMRIS = Rheumatoid Arthritis Magnetic Resonance Image Scoring system, SC = subcutaneous.|Baseline, 6 and 24 weeks|The sub-study analysis set includes those patients who received at least 1 dose of investigational product in the MRI sub-study. Patients were analysed by randomised treatment, but only those with available images were included in the analysis.|||Units on a scale||Inter-Quartile Range|Median
2607186|NCT02092909|Secondary|Pharmacokinetics of Escalating Dose Levels of IMO 8400 Administered by SC Injection - AUC0-t (hr*ng/mL)|Pharmacokinetics of escalating dose levels of IMO 8400 administered by SC injection - AUC0-t (hr*ng/mL) .|Cycle 1 Week 1 Day 1: Samples were obtained pre-dose (within 1 hr prior to injection) and post-dose at 1 hr (+/-5 min), 2 hrs (+/-10 min) and 4 hrs (+/-15 min)||||AUC0-t (hr*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2607187|NCT02092909|Secondary|Pharmacokinetics of Escalating Dose Levels of IMO 8400 Administered by SC Injection - Cmax.|Pharmacokinetics of escalating dose levels of IMO 8400 administered by SC injection - Cmax.|Cycle 1 Week 1 Day 1: Samples were obtained pre-dose (within 1 hr prior to injection) and post-dose at 1 hr (+/-5 min), 2 hrs (+/-10 min) and 4 hrs (+/-15 min)|PK Population|||Cmax (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2607188|NCT02092909|Secondary|Identify the Number of Patients Experiencing DLTs at Each Dose Level|To identify an appropriate dose of IMO-8400 for further clinical evaluation via evaluation of DLT at each dose level|28 days|Safety Population|||Participants|||Count of Participants
2607189|NCT02092909|Secondary|Best Overall Response|Best Overall Response using criteria from the VIth International Workshop in Waldenstrom's Macroglobulinemia|Up to 24 weeks|Efficacy Evaluable Population|||Participants|||Count of Participants
2607190|NCT02092909|Primary|Safety and Tolerability of IMO-8400 in Patients With Waldenstrom's Macroglobulinemia|Safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia: Assessment of adverse events|Up to 24 weeks|Safety Population|||Participants|||Count of Participants
2607191|NCT02092857|Primary|Number of Antigen-presenting B Cells||10 weeks||||percentage of CD20+ B cells|||Number
2607225|NCT02092311|Other Pre-specified|Post-varicocelectomy Testicular Atrophy|development of testicular atrophy is assessed by physical exam at intervals of 3 and 6 months after surgery|6months||||Participants|||Number
2607195|NCT02092662|Primary|Muscle Onset Time.|Assessed by surface electromyography device. The time period it takes the muscle to be activated and contract from a voice prompting is measured. Shorter time onset probably charcterized healthy people compared to patients after a stroke.|the study group was assessed T1 at the beginning of the hospital stay and follow up at T2 one month later. The control group assessed for the the time onset and compared to the study group at T1||||seconds||Standard Deviation|Mean
2607196|NCT02092662|Secondary|Handwriting Velocity|Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks. The velocity of his writing is measured and pass from the tablet to the computer to be processed by the software.|T1 at the beginning of the hospital stay and follow up at T2 one month later.|||||||
2607197|NCT02092662|Secondary|Muscle Co-activation Index.|Assessed by surface electromyography device. Indicate for the level by which muscles contract at the same time and amplitude. It will be calculated in percentage from 100%, as 100% indicate for complete co-activation between a pair of muscles.|T1 at the beginning of the hospital stay and folloew up at T2 one month later.|||||||
2607198|NCT02092662|Primary|Fugl-Meyer Assessment.|zero to 66 points scale, measuring the impairment level of the upper extremity. Zero indicates a high level of impairment or minimum hand motor function, while 66 points indicates an increased motor function which is similar to normal upper extremity function.|T1 at the beginning of the hospital stay and folloew up at T2 one month later.||||units on a scale||Standard Deviation|Mean
2607199|NCT02092649|Secondary|Change in Fasted Blood Triglyceride Concentration From Baseline||Baseline, 12 weeks||||percent change||Standard Deviation|Mean
2607200|NCT02092649|Secondary|Variability of Resting Metabolic Rate Measurement on 2 Consecutive Days||Baseline, 6 weeks, 12 weeks||||percent variability||Standard Deviation|Mean
2607201|NCT02092649|Secondary|Change in Whole Body Resting Carbohydrate Oxidation From Baseline||Baseline, 6 weeks, 12 weeks||||percent change||Standard Deviation|Mean
2607202|NCT02092649|Secondary|Change in Whole Body Resting Fat Oxidation From Baseline||Baseline, 6 weeks, 12 weeks||||percent change||Standard Deviation|Mean
2607203|NCT02092649|Secondary|Change in Maximum Oxygen Consumption From Baseline||Baseline, 12 weeks||||percent change||Standard Deviation|Mean
2607204|NCT02092649|Primary|Change in Resting Metabolic Rate From Baseline|Percent change in resting metabolic rate|Baseline, 6 weeks, 12 weeks||||percent change||Standard Deviation|Mean
2607205|NCT02092610|Secondary|Implant Survival||60 months|"These data are already presented in the Longterm Survival of Implant section."||||||
2607206|NCT02092610|Secondary|Soft Tissue Status|"To evaluate the status of the soft tissue at the implant site.~The scale Holgers Index 4 is designed to capture signs and symptoms of inflammation or infection at the site of implantation. The scale should be completed at the visit.~The scale consists of the following steps:~0. No irritation. Epidermal debris removed, if present~Slight redness. Local temporary treatment, if needed~Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated~Reddish and moist; sometimes granulations tissue, revision surgery is indicated~Removal of the abutment/implant necessary due to infection R. Removal of abutment/implant for reasons not related to skin problems"|At the single 60 months visit|Five year follow up population|||% of participants|||Number
2607207|NCT02092610|Secondary|Longterm Survival of Implant|"To compare the long term survival of the novel implant and abutment and the standard implant and abutment in the Baha system.~All patients will be asked if they have experienced any implant osseointegration problems which would have made the implant to get loose. The time from implant implantation until implant loss or removal will be collected. In case of implant removal, reason for removal shall be recorded."|At the single 60 months visit|Survival population, all patients in the ITT population in the original study CAG5173 (all randomized patients who get surgery).|||% survival rate of implants|||Number
2607208|NCT02092610|Primary|Implant Stability|To show superiority of the novel implant compared to standard implants regarding stability of the implants measured as ISQ values at the abutment level. The ISQ value ranges from 1 to 100, the higher ISQ value, the higher the implant stabilty. Mean AUC 0-60 months ISQ represents a weighted average of the implant stability during the 60 months from start of the CAG5173 study to the measurement in this study CBAS5562. The ISQ 5 years value represents the single ISQ measurment at 5 years.|At the single 60 months visit|The 5 year follow up population consisted of the patients in the ITT population (all randomized subjects who received surgery) in the CAG5173 study who attended this study which was a 5-year follow up visit.|||ISQ scores||Standard Deviation|Mean
2607209|NCT02092441|Other Pre-specified|Satisfaction Measured on a 5-point Likert Scale|"Patient satisfaction of smelling prep pad to alleviate nausea on a scale from 1 (completely unsatisfied) to 5 (completely satisfied)"|10 minutes post intervention||||5 point Likert Scale||Inter-Quartile Range|Median
2607210|NCT02092441|Secondary|Verbal Numerical Rating Scale Pain Score (0-10) at 10 Minutes Post Intervention|"Scale ranges from 0 (no pain) to 10 (worst pain imaginable)"|10 minutes post intervention||||VNRS||Inter-Quartile Range|Median
2607211|NCT02092441|Primary|Nausea Verbal Numerical Rating Scale (0-10) at 10 Minutes Post Intervention|"Primary outcome is nausea and vomiting measured on a scale from 0 (no nausea) to 10 (worst nausea imaginable) Verbal Numerical Response Scale (VNRS) at 10 minutes post intervention."|10 minutes post intervention||||VNRS||Inter-Quartile Range|Median
2607212|NCT02092415|Primary|Muscle Perfusion|Contrast ultrasound perfusion imaging will be performed at baseline and 1 min after application of the JT.|baseline and 1 min post occlusion||||IU/s||Standard Error|Mean
2607213|NCT02092389|Secondary|Correlation Between fC and Workability Determined by WPAI:UC Questionnaire|Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The WPAI:UC is a questionnaire used to evaluate lost productivity (work time missed and work and activity impairment) during the past 7 days due to UC. The scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Baseline (Day 0) to Month 12|The study was terminated due to low enrollment and data were not collected.||||||
2607226|NCT02092311|Secondary|Post-varicocelectomy Hydrocele|Development of hydrocele is assessed by physical exam at intervals of 10 days,3months and 6months after surgery|6months||||Participants|||Number
2607214|NCT02092389|Secondary|Correlation Between fC and Patient's QoL Determined by the sIBDQ|fC is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The sIBDQ is a disease-specific health-related QoL questionnaire, able to detect and define meaningful clinical changes in IBD patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL).|Baseline (Day 0) to Month 12|The study was terminated due to low enrollment and data were not collected.||||||
2607215|NCT02092389|Secondary|Correlation Between fC and Disease Activity Determined by Partial Mayo Score|Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA).|Baseline (Day 0) to Month 12|The study was terminated due to low enrollment and data were not collected.||||||
2607216|NCT02092389|Secondary|Change From Baseline to Month 12 in Disease Activity Determined by Partial Mayo Score|A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]).|Baseline (Day 0) to Month 12|The study was terminated due to low enrollment and data were not collected.||||||
2607217|NCT02092389|Secondary|Change From Baseline to Month 12 in Patient's Quality of Life (QoL) Measured Using the Short Inflammatory Bowl Disease Questionnaire (sIBDQ)|The sIBDQ is a disease-specific health-related quality of life (QoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL). Increased scores correspond to an improvement in QoL.|Baseline (Day 0) to Month 12|The study was terminated due to low enrollment and data were not collected.||||||
2607218|NCT02092389|Secondary|Change From Baseline to Month 12 in Patient's Workability Measured Using the Work Productivity and Activity Impairment:Ulcerative Colitis (WPAI:UC) Questionnaire|The WPAI:UC is a questionnaire used to evaluate lost productivity (work time missed and work and activity impairment) during the past 7 days due to UC. The scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-UC is calculated by deducting the final score from the baseline score. Increased (positive) scores correspond to a reduction in the percentage of lost work productivity.|Baseline (Day 0) to Month 12|The study was terminated due to low enrollment and data were not collected.||||||
2607219|NCT02092389|Primary|Percentage of Patients With Fecal Calprotectin (fC) Level ≤ 150 µg/g After 12 Months of Treatment With Adalimumab|Fecal calprotectin (fC) is a non-invasive surrogate marker of inflammation in the small intestine and levels below 250 ug/g is associated with mucosal healing. fC levels were measured using enzyme-linked immunosorbent assay (ELISA) and/or a validated quantitative rapid test. The study was terminated due to low enrollment. Although no meaningful analysis can be presented, data for subjects with available data for fC levels at Month 12 at the end of study (termination) are provided.|Month 12|Enrolled participants with Month 12 data at the time of study termination|||percentage of participants|||Number
2607220|NCT02092350|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After Completing Study Therapy (SVR4)|SVR4 was defined as HCV RNA <LLoQ 4 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.|Week 16 (Immediate Treatment + Intensive PK) or Week 32 (Deferred Treatment)|The mFAS includes all participants receiving ≥1 dose of drug and without missing data due to death or early discontinuation from study therapy for reasons unrelated to response to HCV treatment.|||Percentage of participants||95% Confidence Interval|Number
2607221|NCT02092350|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)|SVR24 was defined as HCV RNA <LLoQ 24 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.|Week 36 (Immediate Treatment + Intensive PK) or Week 52 (Deferred Treatment)|The mFAS includes all participants receiving ≥1 dose of drug and without missing data due to death or early discontinuation from study therapy for reasons unrelated to response to HCV treatment.|||Percentage of participants||95% Confidence Interval|Number
2607222|NCT02092350|Primary|Number of Participants Discontinuing Study Drug Due to AEs During the Initial Treatment Period|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.|Up to Week 12|The APaT population includes all enrolled participants who received at least one dose of study drug.|||Participants|||Number
2607223|NCT02092350|Primary|Number of Participants Experiencing an Adverse Event (AE) During the Initial Treatment and 14-day Follow-up Periods|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. This analysis includes the Immediate Treatment + Intensive PK group and the placebo treatment period for the Deferred Treatment group.|Up to Week 14|The All Participants as Treated (APaT) population includes all enrolled participants who received at least one dose of study drug.|||Participants|||Number
2607224|NCT02092350|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)|SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) lower than the limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0®, which has a LLoQ of 15 IU/mL.|Week 24 (Immediate Treatment + Intensive PK) or Week 40 (Deferred Treatment)|The modified Full Analysis set (mFAS) includes all participants receiving ≥1 dose of drug and without missing data due to death or early discontinuation from study therapy for reasons unrelated to response to HCV treatment.|||Percentage of participants||95% Confidence Interval|Number
2607228|NCT02092285|Primary|Percentage of Participants Meeting Partial Mayo Score Response Criteria Through Week 54|The Partial Mayo Score (Mayo Score without endoscopy) measures severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician's global assessment are each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores are then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease). Clinical response is defined as a decrease in PMS of ≥2 points and ≥30% from baseline, plus either a decrease in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of ≤1. In this outcome measure, the percentage of participants starting treatment at the start of the Induction Phase (Baseline) who obtained clinical response by the end of the Induction Phase (i.e., by Week 6) and maintained clinical response through Week 54 (i.e., had positive clinical responses at both Weeks 30 and 54) are estimated.|Baseline (Week 0), Week 6, Week 30, Week 54|The analysis population for the evaluation of efficacy during the maintenance period was the Full Analysis Set (FAS205) consisting of participants who received at least 1 dose of golimumab.|||Percentage of Participants||95% Confidence Interval|Number
2607229|NCT02092220|Other Pre-specified|CGM Mean Absolute Relative Differences (MARD) Versus Time-stamped Blood Glucose (BG) Values From Meter Downloads|This outcome measure compares the time stamped PG values from the glucose meter to the corresponding CGM glucose value to determine the overall accuracy of the CGM.|11 days|All randomized participants who completed both periods.|||percent difference||Standard Deviation|Mean
2607230|NCT02092220|Other Pre-specified|Mean Daily Bolus Insulin Dose|Daily bolus insulin dose reported in Units per kilogram per day (U/kg/day).|Day 1, Days 1 to 11, Days 2 to 11, each individual day 2 to 11 of each period|All randomized participants who completed both periods of the study.|||U/kg/day||Standard Deviation|Mean
2607231|NCT02092220|Other Pre-specified|Mean Daily Basal Insulin Dose|Daily basal insulin dose reported in Units per kilogram per day (U/kg/day).|Day 1, Days 2 to 11, each individual day 2 to 11 of each period|All randomized participants who completed both periods of the study.|||U/kg/day||Standard Deviation|Mean
2607232|NCT02092220|Other Pre-specified|Number of Unscheduled Infusion Set Replacements||11 days|All randomized participants who completed both periods of the study. Glucagon infusion sets are not applicable to the Usual Care arm.|||Infusion Set Relacements|||Number
2607233|NCT02092220|Other Pre-specified|Reliability Index, Calculated as Percent of Possible Values Actually Recorded by CGM||11 days|All randomized participants who completed both periods.|||percentage of possible values||Standard Deviation|Mean
2607234|NCT02092220|Secondary|Number of Participants With Skin Rash||11 days of each period|All randomized participants who completed both periods of the study.|||Participants|||Count of Participants
2607235|NCT02092220|Secondary|Change From Baseline in Hemoglobin|The change in the value of hemoglobin collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in hemoglobin and a positive change from Baseline indicates an increase in hemoglobin.|Baseline and Day 12 of each period|All randomized participants who completed both periods of the study.|||grams/deciliter (mg/dL)||Standard Deviation|Mean
2607236|NCT02092220|Secondary|Change From Baseline in Body Weight|The change in body weight collected at Day 12 relative to Baseline. A negative change from Baseline indicates a reduction in body weight and a positive change from Baseline indicates an increase in body weight.|Baseline and Day 12 of each period|All participants who completed both periods of the study.|||kilograms||Standard Deviation|Mean
2607237|NCT02092220|Secondary|Mean Nausea Index Score Using a Visual Analog Scale (VAS)|Participants rated their nausea using a 0 to 10 centimeter (cm) VAS where 0=least severe nausea to 10=most severe nausea. The average nausea index scores during Days 1 to 11 and Days 2 to 11 were calculated.|Day 1, Days 1 to 11, Days 2 to 11 and each individual day 2 to 11 of each period|All randomized participants who completed both periods of the study.|||cm||Standard Deviation|Mean
2607238|NCT02092220|Secondary|Percentage of Time Bionic Pancreas Off-line or Not Functioning Properly|Not functioning properly includes issues due to system crash, communication problems between CGM and bionic pancreas, communication problems between bionic pancreas and pumps and pump malfunction.|11 days|All randomized participants who completed both periods of the study. Reported for the Bionic pancreas arm only|||percentage of time||Standard Deviation|Mean
2607239|NCT02092220|Secondary|Mean Glucose Target Set by User (Time-weighted Average Over Study Period) in the Bionic Pancreas Arm||Day 1, Days 2 to 11, Days 1 to11, Overall, Daytime, Nighttime of each period|All randomized participants who completed both periods of the study.|||mg/dL||Standard Deviation|Mean
2607240|NCT02092220|Secondary|Glucagon Total Daily Dose Levels in the Bionic Pancreas Arm|Glucagon dose level is reported in micrograms per kilogram of body mass per day (µg/kg/day).|Day 1, Days 2 to 11, Days 1 to 11 of each period|All participants who completed both periods of the study. Results are reported for the Bionic Pancreas period only.|||µg/kg/day||Standard Deviation|Mean
2607241|NCT02092220|Secondary|Insulin Total Daily Dose|Insulin total daily dose is reported in units per kilogram per day (U/kg/day).|Day 1, Days 1 to 11, Days 2 to 11 of each period|All participants who completed both periods of the study.|||U/kg/day||Standard Deviation|Mean
2607242|NCT02092220|Secondary|Total Grams of Carbohydrate Taken for Hypoglycemia|"The total grams of carbohydrate taken for hypoglycemia as reported daily by the participant were averaged.~The total number of grams of carbohydrate taken for hypoglycemia were reported daily by the participant. The total number of grams of carbohydrate taken are reported."|Day 1, Days 1 to 11 and Days 2 to 11 of each period|All participants who completed both periods of the study.|||grams of carbohydrate per day||Standard Deviation|Mean
2607243|NCT02092220|Secondary|Number of Reported Carbohydrate Interventions for Hypoglycemia|The number of carbohydrate interventions for hypoglycemia were reported daily by the participant. The average number of carbohydrate interventions per day is reported.|Day 1, Days 1 to 11 and Days 2 to 11 of each period|All participants who completed both periods of the study.|||interventions per day||Standard Deviation|Mean
2607244|NCT02092220|Secondary|Number of Episodes of Symptomatic Hypoglycemia|The number of episodes of symptomatic hypoglycemia were reported daily by the participant. The average number of episodes of symptomatic hypoglycemia per day was calculated.|Day 1, Days 1 to 11 and Days 2 to 11 of each period|All participants who completed both periods of the study.|||episodes per day||Standard Deviation|Mean
2607246|NCT02092220|Secondary|Anti-Insulin and Anti-Glucagon Antibodies on Day 12||Day 12 of each period|No data was collected for Anti-Insulin and Anti-Glucagon Antibodies.||||||
2607249|NCT02092220|Secondary|Percentage of Days That CGM Was Used by Participants as Part of Their Usual Care|The percentage of days that participants reported the CGM device was being worn and working properly is reported.|Days 1-11 of each period|All randomized participants who completed both periods of the study. This outcome measure applies only to the Usual Care arm.|||percentage of days|||Number
2607250|NCT02092220|Secondary|Number of Hypoglycemic Events (< 70 mg/dL, < 60 mg/dL, <50 mg/dL)|A series of hypoglycemic measurements is defined as a single event until there is a break of ≥ 30 minutes between measurements below the defined thresholds of < 70, < 60, and <50 mg/dL.|Days 1-11||||hypoglycemic events||Standard Deviation|Mean
2607251|NCT02092220|Secondary|Percentage of Participants With Mean CGMG < 154 mg/dl|Glucose reading were taken every 5 minutes by the CGM. The glucose readings were averaged. 154 mg/dL was the estimated average glucose corresponding to a Glycosylated Hemoglobin A1C of 7%.|Day 1, Days 2 to11, Days 1 to11 of each period|All randomized participants who completed both periods of the study.|||percentage of participants|||Number
2607252|NCT02092220|Secondary|Percentage of Time With CGMG Concentration by Ranges During Days 2 to 11|"Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated:~< 50 mg/dL (2.8 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)"|Days 2 to 11 of each period|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
2607253|NCT02092220|Secondary|Percentage of Time With CGMG Concentration by Ranges During Days 1 to 11|"Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated:~< 50 mg/dL (2.8 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)"|Days 1 to 11 of each period|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
2607254|NCT02092220|Secondary|Percentage of Time With CGMG Concentration by Ranges During Day 1|"Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than the following ranges were calculated:~< 50 mg/dL (2.8 mmol/L) < 60 mg/dL (3.3 mmol/L) < 70 mg/dL (3.9 mmol/L) 70 to 120 mg/dL (3.9 to 6.7 mmol/L) 70 to180 mg/dl (3.9 to 10.0 mmol/L) > 180 mg/dL (10.0 mmol/L) > 250 mg/dL (13.9 mmol/L)"|Day 1 of each period|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
2607255|NCT02092220|Secondary|Mean CGMG Values|Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 1 and Days 1 to 11 were averaged.|Day 1 and Days 1 to 11 in each period|All randomized participants who completed both periods of the study.|||mg/dL||Standard Deviation|Mean
2607256|NCT02092220|Primary|Percentage of Time Spent With CGMG Concentration < 60 mg/dL During Days 2 to 11|Glucose reading were taken every 5 minutes by the CGM.The percentage of time that the glucose concentration was less than 60 mg/dL [3.3 millimoles/liter (mmol/L)] during Days 2 to 11 was calculated.|Days 2 to 11 of each period|All randomized participants who completed both periods of the study.|||percentage of time||Standard Deviation|Mean
2607257|NCT02092220|Primary|Mean Continuous Glucose Monitoring Glucose (CGMG) Values During Days 2 to 11|Glucose reading were taken every 5 minutes by the CGM. The glucose results on Days 2 to 11 were averaged.|Days 2 to 11 of each period|All randomized participants who completed both periods of the study.|||milligrams/deciliter (mg/dL)||Standard Deviation|Mean
2607258|NCT02092168|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration|AUC0-t - Area under the plasma concentration-time curve of BIA 9-1067 from time 0 to last observed concentration|Day 1 and Day 7||||ng.h/mL||Standard Deviation|Mean
2607259|NCT02092168|Primary|Tmax - Time to Reach Cmax|Tmax - Time to reach maximum plasma concentration of BIA 9-1067|Day 1 and Day 7||||hours||Full Range|Median
2607260|NCT02092168|Primary|Cmax - Maximum Plasma Concentration|Cmax (BIA 9-1067) - maximum plasma concentration of BIA 9-1067|Day 1 and Day 7||||ng/mL||Standard Deviation|Mean
2607261|NCT02092116|Secondary|Part B: Level of HIV-1 Transcription.|At day 105, 112 and 119 patients receive romidepsin and 4 hours after each administration HIV transcription is measured as unspliced HIV-1 RNA.|Day 105, 112 and 119|All available samples were included in this analysis; 3 withdrew consent and 2 (3 for day 119) did not have analyzable samples.|||copies/10^6 CD4+ T cells||Standard Deviation|Mean
2607262|NCT02092116|Secondary|Part B: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|Safety and tolerability evaluation of romidepsin and Vacc-4x in combination with GM-CSF as measured by adverse events (AE) and serious adverse events (SAE).|287 days||||participants|||Number
2607263|NCT02092116|Secondary|Part A: Changes From Baseline in HIV-1 Reservoir (Total HIV-1DNA; Integrated HIV-1 DNA in Unfractionated CD4+ T Cells and Replication Competent Provirus. Estimates of Change From Baseline of the Size of the Latent HIV-1 Reservoir in CD4+ Cells.|"Total HIV-1 DNA and integrated HIV-1 DNA were analysed by MMRM analysis (copies/10^6 CD4+ T cells). To estimate the frequency of infectious units per 10^6 resting memory CD4+ T cells a quantitative viral outgrowth assay (qVOA) was used.~Total HIV-1 DNA was measured at Day 84"|Day 56/84|1 patient did not have a quantifiable load of total HIV-1 DNA at Day 84 and 2 patients diod not have a quantifiable load of replication competent provirus at day 56.|||copies/10^6 CD4+ T cells||Standard Deviation|Mean
2607264|NCT02092116|Primary|Part B: Changes From Baseline in HIV-1 Reservoir (Total HIV-1DNA; Integrated HIV-1 DNA in Unfractionated CD4+ T Cells and Replication Competent Provirus.|"Total HIV-1 DNA and integrated HIV-1 DNA were analysed by MMRM analysis (copies/10^6 CD4+ T cells). To estimate the frequency of infectious units per 10^6 resting memory CD4+ T cells a quantitative viral outgrowth assay (qVOA) was used.~Blood samples were obtained at Day 0, Day 105 and Day 161."|Day 161/175|"4 patients were excluded; 3 discontinued and 1 sample was not eligible for analysis.~Sensitivity of the qVOA was low; 2/3 of all measurements were under the limit of detection. 6 subjects had quantifiable viral outgrowth on baseline, 8 had viral outgrowth after immunization (Day 105) and 6 had viral outgrowth after romidepsin (Day 161)."|||Estimated % change from baseline||95% Confidence Interval|Mean
2607265|NCT02092116|Primary|Part A: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|Safety and tolerability evaluation as measured by adverse events (AE) and serious adverse events (SAE).|3 weeks||||participants|||Number
2607266|NCT02092025|Secondary|Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point|Reported data are changes in DBP from baseline at Month 1 and final assessment (up to 12 months).|Baseline, Month 1 and Final assessment (up to 12 Months)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given time point.|||mmHg||Standard Deviation|Mean
2607267|NCT02092025|Secondary|Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point|Reported data are changes in SBP from baseline at Month 1 and final assessment (up to 12 months).|Baseline, Month 1 and final assessment (up to 12 Months)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'n' is number of participants analyzed at the given time point.|||mmHg||Standard Deviation|Mean
2607268|NCT02092025|Primary|Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)|ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Up to 12 Months|Safety Analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2607269|NCT02091986|Secondary|Number of Patients With an Asthma Exacerbation During Study|Number of patients that experienced an asthma exacerbation that required either emergency room treatment, hospitalization, systemic steroids, or an increase in, or additional asthma maintenance medication, during the study.|Week 0 (baseline) up to Week 12|"All patients randomized who:~received at least one dose of study medication;~data collected after randomisation. Patients accounted for according to the treatment they actually received."|||Partcicipants|||Number
2607270|NCT02091986|Secondary|Change From Baseline to Study Period Average in Overall PAQLQ Score|"Study period average is defined as the average of the post-baseline values during the study taken after first dose of investigational product up to and including withdrawal from study or Week 12, minus the baseline assessment at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).~The PAQLQ(S) is a 23-item patient-reported questionnaire, each one reported on a 7-point scale (e.g. 1 = extremely bothered/all of the time; 7 = not bothered/none of the time). The PAQLQ(S) generates an overall score, as well as 3 domain scores: activity limitations (5 items), symptoms (10 items) and emotional function (8 items). The overall score will be calculated as the mean of the responses to each of the 23 questions (ie the range of 1-7, where higher scores indicate better quality of life). If any of the domain scores are missing, no total score will be calculated."|Week 0 (baseline), week 4, week 8, week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||unit on a scale||95% Confidence Interval|Least Squares Mean
2607271|NCT02091986|Secondary|Change From Baseline to End of Study Average in Total Daily Reliever Medication|End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||Number of reliever medication use||Standard Deviation|Mean
2607272|NCT02091986|Secondary|Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms|End of study average is defined as the percentage of nighttime awakenings due to asthma symptoms from 6 days before up to and additionally including the morning of withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||Percentage of nighttime awakenings||Standard Deviation|Mean
2607273|NCT02091986|Secondary|Change From Baseline to End of Study Average in Total Asthma Symptoms|"End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).~Patient to record his/her asthma symptom score twice daily. The following rating scales are to be used: 0 = None; no symptoms of asthma~= Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated~= Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep~= Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep~Total asthma symptom score is derived as the sum of the daytime score plus the score from the previous nighttime, ie possible range (0 to 6)."|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||units on a scale||Standard Deviation|Mean
2607274|NCT02091986|Secondary|Change From Baseline to Week 12 in 15 Min Post-dose FEV1|15 min Post-dose FEV1 is defined as the 15 min post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||Liters||95% Confidence Interval|Least Squares Mean
2607275|NCT02091986|Secondary|Change From Baseline to Week 12 in Pre-dose FVC|Pre-dose FVC is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||Liters||95% Confidence Interval|Least Squares Mean
2607276|NCT02091986|Secondary|Change From Baseline to Week 12 in Pre-dose FEF25-75|Pre-dose FEF25-75 is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||Liters per minute||95% Confidence Interval|Least Squares Mean
2607277|NCT02091986|Secondary|Change From Baseline to Week 12 in Pre-dose PEF|Pre-dose PEF is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||Liters per minute||95% Confidence Interval|Least Squares Mean
2607278|NCT02091986|Secondary|Change From Baseline to Week 12 in Pre-dose FEV1|Pre-dose FEV1 is defined as the pre-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||Liters||95% Confidence Interval|Least Squares Mean
2607279|NCT02091986|Secondary|Change From Baseline to Week 12 in 1h Post-dose FVC|1h post-dose FVC is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||Liters||95% Confidence Interval|Least Squares Mean
2607280|NCT02091986|Secondary|Change From Baseline to Week 12 in 1h Post-dose FEF25-75|1h post-dose FEF25-75 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint. Patients accounted for according to the treatment to which they were randomized."|||Liters per second||95% Confidence Interval|Least Squares Mean
2607281|NCT02091986|Secondary|Change From Baseline to Week 12 in 1h Post-dose PEF|1h post-dose PEF is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint.~Patients accounted for according to the treatment to which they were randomized."|||Liters per minute||95% Confidence Interval|Least Squares Mean
2607282|NCT02091986|Primary|Change From Baseline to Week 12 in 1h Post-dose FEV1|1h post-dose FEV1 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).|Week 0 (baseline), Week 12|"All patients randomized who:~received at least one dose of study medication;~the patient contributed data for at least one efficacy endpoint.~Patients accounted for according to the treatment to which they were randomized."|||Liters||95% Confidence Interval|Least Squares Mean
2607283|NCT02091960|Secondary|Number of Participants With Adverse Events (AEs)|"An AE was defined as any untoward medical occurrence in a patient administered study drug or who underwent study procedures and did not necessarily have a causal relationship with treatment. An abnormality identified during a medical test was defined as an AE only if the abnormality induced clinical signs or symptoms, required active intervention, required interruption or discontinuation of study medication, or was clinically significant in the opinion of the investigator.~An AE was defined as serious if it resulted in any of the following outcomes:~Death~Was life-threatening~Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions~Congenital anomaly, or birth defect~Inpatient hospitalization or prolongation of hospitalization~Other medically important event. Drug-related AEs were those assessed by the investigator as AEs whose relationship to the to the study drugs could not be ruled out."|From the first dose date of study drug to 30 days after the last dose date of study drug or the start of subsequent treatment or date of death, whichever was first; median duration of treatment was 70 days, and the maximum was 660 days.|The safety analysis set included all participants who received at least 1 or partial dose of study drug.|||Participants|||Count of Participants
2607284|NCT02091960|Secondary|Time to Response|Time to response was defined as the time from the first date of enzalutamide treatment to initial CR or PR and was calculated for participants with a CR or PR.|From the date of first dose of study drug to the data cut-off date of 28 February 2017; the median duration of treatment was 70 days, and the maximum was 660 days.|Efficacy evaluable set with a best overall response of CR or PR|||days||95% Confidence Interval|Median
2607285|NCT02091960|Secondary|Duration of Response|Duration of response was defined as the time from the date of first documentation of response (CR or PR) until the date of disease progression per RECIST 1.1. Participants who initiated another anti-tumor therapy before documented PD, progressed after missing two or more consecutive radiological assessments or who died before disease progression were censored at the date of the last radiological assessment showing no progression.|Tumor assessments were performed every 8 weeks through week 49, and then every 12 weeks thereafter until disease progression, initiation of new therapy or withdrawal of consent. The median duration of treatment was 70 days, and the maximum was 660 days.|Efficacy evaluable set participants with a best overall response of CR or PR|||days||95% Confidence Interval|Median
2607294|NCT02091921|Primary|To Determine Platelet Inhibition Before and After Switching for Two Weeks From Clopidogrel to Ticagrelor in Patients With CLI.|Patients platelet inhibition was analyzed based on the P2Y12 reaction units (PRU) as high on treatment platelet reactivity (HPR), defined as P2Y12 reaction units (PRU) ≥208 and appropriate platelet inhibition on (API), defined as P2Y12 reaction units (PRU) <208|Two weeks||||P2Y12 reaction units (PRU)||95% Confidence Interval|Mean
2607286|NCT02091960|Secondary|Time to Progression|Time to progression was defined as the time from the first date of enzalutamide treatment until the date of disease progression per RECIST 1.1. Participants who initiated another anti-tumor therapy before documented PD, who progressed after missing two or more consecutive radiological assessments or who died before disease progression were censored at the date of the last radiological assessment showing no progression.|From the date of first dose of study drug to the data cut-off date of 28 February 2017; the median duration of treatment was 70 days, and the maximum was 660 days.|Efficacy analysis set|||days||Full Range|Median
2607287|NCT02091960|Secondary|Progression-free Survival|"Progression-free survival was defined as the time from the date of first dose of enzalutamide until the date of disease progression per RECIST 1.1, or death from any cause on study, whichever occurred first. Participants who initiated another antitumor therapy before documented progressive disease (PD) or death, or who progressed or died after missing 2 or more consecutive radiological assessments were censored at the date of the last radiological assessment showing no progression.~Progressive disease was defined as a ≥ 20% increase in the size of target lesions and at least a 5 mm increase in size of target lesions from smallest size on study, or unequivocal progression of non-target lesions, or any new lesions."|From the date of first dose of study drug to the data cut-off date of 28 February 2017; the median duration of treatment was 70 days, and the maximum was 660 days.|Efficacy evaluable set|||days||95% Confidence Interval|Median
2607288|NCT02091960|Secondary|Best Overall Response Rate|"Best overall response was the best response across all time points, based on investigator assessments.~Best overall response rate was defined as the percentage of evaluable participants with a best objective response of confirmed complete response (CR) or partial response (PR) at any time during the study per RECIST 1.1.~Complete response was defined as the disappearance of all target and non-target lesions and no new lesions, and lymph nodes all < 10 mm in short axis.~Partial response was defined as disappearance of target lesions or a ≥ 30% decrease in the size of target lesions with persistence of non-target lesions and no new lesions.~PR and CR required confirmation with equivalent or improved assessment no less than 4 weeks after the date of scan that PR or CR was first observed."|Tumor assessments were performed every 8 weeks through week 49, and then every 12 weeks thereafter until disease progression, initiation of new therapy or withdrawal of consent. The median duration of treatment was 70 days, and the maximum was 660 days.|Efficacy evaluable set|||percentage of participants||95% Confidence Interval|Number
2607289|NCT02091960|Secondary|Overall Response Rate at Week 24|"Overall response rate was defined as the percentage of evaluable participants with a best objective response of confirmed complete response (CR) or partial response (PR) per RECIST 1.1.~Complete response was defined as the disappearance of all target and non-target lesions and no new lesions, and lymph nodes all < 10 mm in short axis.~Partial response was defined as disappearance of target lesions or a ≥ 30% decrease in the size of target lesions with persistence of non-target lesions and no new lesions.~PR and CR required confirmation with equivalent or improved assessment no less than 4 weeks after the date of scan that PR or CR was first observed."|24 weeks|Efficacy evaluable set|||percentage of participants||95% Confidence Interval|Number
2607290|NCT02091960|Primary|Clinical Benefit Rate (CBR)|"Clinical benefit rate was defined as the percentage of evaluable participants with best objective response of confirmed complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or prolonged stable disease (≥ 24 weeks).~Complete response (CR) was defined as the disappearance of all target and non-target lesions and no new lesions, and lymph nodes all < 10 mm in short axis.~Partial response (PR) was defined as disappearance of target lesions or a ≥ 30% decrease in the size of target lesions, with persistence of non-target lesions and no new lesions.~Stable disease (SD) was defined as < 30% decrease and < 20% increase in the size of target lesions, persistence of non-target lesions, and no new lesions.~PR and CR required confirmation with equivalent or improved assessment no less than 4 weeks after the date that PR or CR was first observed. SD required confirmation with equivalent or improved assessment no less than 8 weeks after enrollment."|Tumor assessments were performed every 8 weeks through week 49, and then every 12 weeks thereafter until disease progression, initiation of new therapy or withdrawal of consent. The median duration of treatment was 70 days, and the maximum was 660 days.|The efficacy evaluable set (EES) includes all enrolled participants who had centrally assessed androgen receptor positive (AR+; defined as ≥ 10% of tumor cells with nuclear expression), received at least one dose of study drug, and had at least one available post baseline tumor assessment.|||percentage of participants||95% Confidence Interval|Number
2607291|NCT02091921|Secondary|Evaluate the Correlation Between PRU and VASP-PRI in CLI Patients During Clopidogrel Versus Ticagrelor Antiplatelet Therapy.|Correlation between the P2Y12 Reaction Units (PRU) and the Vasodilator-Stimulated Phosphoprotein Assay-Platelet Reactivity Index (VASP-PRI) used to test the inhibition of platelet aggregation after two weeks of uninterrupted therapy with Clopidogrel versus Ticagrelor in CLI participants|Two weeks|All participants were on Clopidogrel 75mg daily for at least two weeks and then switched to Ticagrelor 90mg twice daily for two weeks of uninterrupted therapy|||Correlation Coefficient|Correlation Coefficient||Number
2607292|NCT02091921|Secondary|Establish the Number of Participants With Appropriate Platelet Inhibition on Clopidogrel Who Demonstrated Appropriate Platelet Inhibition After Switching to Ticagrelor for Two Weeks.|The measure was obtained from the number of participants in the Appropriate Platelet Inhibition (PRU < 208) on Clopidogrel and who remained with Appropriate Platelet Inhibition after switching to Ticagrelor for two weeks of uninterrupted therapy x 100|Two weeks|Participants who demonstrated API on Clopidogrel and remained with API after switching to Ticagrelor|||Participants|||Count of Participants
2607293|NCT02091921|Secondary|Establish the Number of Participants in the High On-treatment Platelet Reactivity (HPR) on Clopidogrel Group Who Demonstrated Appropriate Platelet Inhibition (API) After Switching to Ticagrelor for Two Weeks.|This measure was obtained by the number of participants who demonstrated high on treatment platelet reactivity (PRU > / = 208) on Clopidogrel, and the number of participants who also resulted in the Appropriate Platelet Inhibition (PRU < 208) after switching to Ticagrelor for two weeks of uninterrupted therapy x 100% .|Two weeks|Participants who demonstrated on the High Platelet Reactivity (HPR) on clopidogrel and had Appropriate Platelet Inhibition (API) on ticagrelor|||Participants|||Count of Participants
2607308|NCT02091752|Secondary|Proportion of Patients Achieving ≥25% and ≥50% Reduction, Respectively, From Baseline in Total Symptom Score (MPN-SAF TSS)||Week 24|The study was terminated early due to low enrollment. Analysis was not done.||||||
2607295|NCT02091869|Other Pre-specified|Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans|We measured the participant usage rates by frequency of a mobile asthma action plan compared to usage rates of a paper asthma action plan. No mobile usage data was collected for the paper asthma plan group; and no paper usage data was collected for mobile phone group.|Six months|Mobile phone usage was not assessed in the paper asthma action plan group.|||times per week||Full Range|Median
2607296|NCT02091869|Other Pre-specified|Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans|We measured the participant usage rates by frequency of a mobile asthma action plan compared to usage rates of a paper asthma action plan. No mobile usage data was collected for the paper asthma plan group; and no paper usage data was collected for mobile phone group.|Six months|Our staff biostatistician used a random number generator using ANCOVA model to assign all participants into either the mobile app or paper app groups per protocol. Three participants did not use the mobile app per protocol.|||days per week||Full Range|Median
2607297|NCT02091869|Secondary|Change in Asthma Self-Efficacy Scores|"The Child Self-Efficacy instrument is a 14 item validated questionnaire designed to measure the child's self-efficacy with regard to attack prevention and attack management. The child will be required to select one of 5 responses ranging from not at all sure (1 point); a little bit sure (2 points); fairly sure (3 points); quite sure (4 points) to completely sure (5 points). Total score range from 14-70. The attack prevention scale range from 6-30 and attack management range from 8-40. The higher score represent a greater degree of self-efficacy. The Cronbach's α reliability = 0.75. The child self-efficacy questionnaire will be administered at baseline (pre-intervention) and at the end of the intervention (post-intervention)."|Baseline and Six months|Our staff biostatistician used a random number generator using ANCOVA model to assign all participants into either the mobile app or paper app groups per protocol.|||units on a scale||Full Range|Median
2607298|NCT02091869|Primary|Change in Asthma Control Test Scores|"The Asthma Control Test™ (ACT) is a 5 question health survey used to measure asthma control in individuals 12 years of age and older. The total sum scores range from 5-25. Higher scores mean that asthma is more controlled. The ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. ACT helps identify and detect asthma patients who are not well controlled. ACT scores were examined pre- and post-intervention. A score total of 19 or less means asthma may not be well controlled. The timeframe is during the past 4 weeks. The scale range for Question 1 is all the time (1) to none of the time (5); Question 2 range: more than once a day (1) to not at all (5); Question 3 range: 4 or more nights a week (1) to not at all (5); Question 4 range: 3 or more times per day (1) to not at all (5); Question 5 range: not controlled at all (1) to completely controlled (5)."|Baseline and Six months|Our staff biostatistician used a random number generator using ANCOVA model to assign all participants into either the mobile app or paper app groups per protocol. The biostatistician was not be involved in testing or intervention procedures.|||units on a scale||Full Range|Median
2607299|NCT02091856|Primary|Beck Depression Inventory II (BDI-II)|"The Beck Depression Inventory-II (BDI-II) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.~This represents the measure of depression at 6 month after the intervention."|Absolute values (average score) of BDI-II at 37 weeks (follow-up)|Only 10 participants from the C-CBT and 9 participants from the R-CBT completed the follow-up assessment questionnaires. Participants from the Wailt-List Control Group were lost at follow-up.|||units on a scale||Standard Deviation|Mean
2607300|NCT02091856|Secondary|Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)|"The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 27. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.~This represents a secondary outcome measure for depression taken immediately after the intervention."|Absolute values (average score) of QIDS-SR after 11 weeks (post-treatment)||||units on a scale||Standard Deviation|Mean
2607301|NCT02091856|Secondary|Quality of Life Inventory (QOLI)|"The Quality of Life Inventory (QOLI) is an established rating scale of self-perceived quality of life across 16 domains. The scale is unidimensional and the total score rages from -6 to +6. Low scores are associated with low self-perceived life quality, while high scores are associated with high self-perceived life quality.~This represents the post-intervention assessment."|Absolute values (average score) of QOLI at 11 weeks (post-intervention)||||units on a scale||Standard Deviation|Mean
2607302|NCT02091856|Secondary|Beck Anxiety Inventory (BAI)|"The Beck Anxiety Inventory (BAI) was designed to measure participant's level of anxiety. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety.~This represent the post-intervention assessment."|Absolute values (average score) of Back Anxiety Inventory at 11 weeks (post-intervention)||||units on a scale||Standard Deviation|Mean
2607303|NCT02091856|Primary|Beck Depression Inventory-II (BDI-II)|"The Beck Depression Inventory-II (BDI-II) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.~This represents the post-intervention assessment."|Absolute values (average score) of Back Depression Inventory-II at 11 weeks (post-intervention)||||units on a scale||Standard Deviation|Mean
2607304|NCT02091778|Primary|Change in Peri-wound Skin|Measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin|12 weeks|number of patients with healthy/intact peri-wound skin that increased from baseline to final visit. (From 6 to 14)|||participants|||Number
2607305|NCT02091752|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EuroQol (EQ)-5D-5L Scores||Baseline, Day 1, Week 8, Week 12, Week 16, Week 24|The study was terminated early due to low enrollment. Analysis was not done.||||||
2607306|NCT02091752|Secondary|Patient Global Impression of Change (PGIC) Score||Week 1, Week 24|The study was terminated early due to low enrollment. Analysis was not done.||||||
2607307|NCT02091752|Secondary|Change From Baseline in MPN-SAF TSS Score||Baseline, Week 24|The study was terminated early due to low enrollment. Analysis was not done.||||||
2607313|NCT02091739|Secondary|MP: Global Impression of Change Scale (GICS) at Week 1, 2, 8 and 12|The GICS was used to measure the investigator's impression of change due to treatment. The response option was a common 7-point Likert scale that ranged from -3 = very much worse to +3 = very much improved and was applicable for participant and caregiver. If the participant was not able to answer then carer's rating was to be recorded instead of participant's rating and the participant's rating was left blank.|Week 1, 2, 8, and 12|The FAS is the subset of participants who were treated and had at least the baseline value of uSFR.|||units on a scale||Standard Error|Least Squares Mean
2607314|NCT02091739|Secondary|MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 8 and 12|uSFR was assessed by weighing of dental rolls soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes and the average of the 2 results for flow rate was calculated.|Baseline, Week 8 and 12|Analysis covers all participants from FAS who have at least one post-baseline uSFR assessment. The FAS is the subset of participants who were treated and had at least the baseline value of uSFR.|||g/min||Standard Error|Least Squares Mean
2607315|NCT02091739|Primary|MP: Participant's Global Impression of Change Scale (GICS) at Week 4|The GICS was used to measure the impression of change due to treatment. The response option was a common 7-point Likert scale that ranged from -3 = very much worse to +3 = very much improved and was applicable for participant and caregiver. If the participant was not able to answer then carer's rating was to be recorded instead of participant's rating and the participant's rating was left blank.|Week 4|The FAS is the subset of participants who were treated and had at least the baseline value of uSFR.|||units on a scale||Standard Error|Least Squares Mean
2607316|NCT02091739|Primary|MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 4|uSFR was assessed by weighing of dental rolls soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes and the average of the 2 results for flow rate was calculated.|Baseline and Week 4|Analysis covers all participants from FAS who have at least one post-baseline uSFR assessment. The FAS is the subset of participants who were treated and had at least the baseline value of uSFR.|||gram per minute (g/min)||Standard Error|Least Squares Mean
2607317|NCT02091726|Secondary|Participant Fully Satisfied and Would Recommend to Friends and Family|Yes to both of the following questions: Are you fully satisfied with your circumcision result? Would you recommend circumcision to friends or family?|4 weeks|104 men came for their 4-week followup, but 1 man did not complete the satisfaction questions.|||participants|||Number
2607318|NCT02091726|Secondary|Cosmetic Result Excellent|Excellent: scar line straight without any irregularity Irregular: Some irregularity to scar line Scalloped: wavy appearane to scar line|4 weeks|104 men came for their 4-week followup but the doctor(s) failed to note the cosmetic result in 2 men.|||participants|||Number
2607319|NCT02091726|Secondary|Wound Separation|Wound separation caused by adhesive failure (minor --requires no treatment)|4 weeks|Wound dehiscence < 2 cm. None required treatment. There were no participants with wound dehiscence > 2 cm.|||participants|||Number
2607320|NCT02091726|Secondary|Completely Healed at 4 Weeks|Definition: Completely epithelialized; no superficial ulcerations or granulation tissue present|4 weeks||||participants|||Number
2607321|NCT02091726|Primary|Time for Procedure|Intraoperative time, total|1 hour||||Min||Inter-Quartile Range|Median
2607322|NCT02091531|Secondary|Best Response|We propose to study both FDG and optional FDHT PET imaging at baseline, 4 weeks after treatment initiation and at the time of progression (end-of-treatment), and to correlate the changes with treatment response. Response and progression will be evaluated in this study using a combination of the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee and modified for prostate cancer and the guidelines for prostate cancer endpoints developed by the Prostate Cancer Clinical Trials Working Group (PCWG2).21|Duration of Treatment, up to 30 weeks||||Participants|||Count of Participants
2607323|NCT02091531|Secondary|Median PSA Rise at End of Treatment as Compared to Baseline|Summary tables and waterfall plots describing change in PSA relative to baseline will be reported at end of treatment|Duration of Treatment, up to 30 weeks||||percentage PSA increase from basline||Full Range|Median
2607324|NCT02091531|Primary|Median Time on Treatment|from the start of treatment, as defined by the Prostate Cancer Working Group 2 (PCWG2) guidelines.|Up to 8 months||||weeks||Full Range|Median
2607325|NCT02091466|Primary|Maternal Hypothermia|Hypothermia was measured by means of tympanic temperatures.|60 minutes|Sample size was calculated to be 20 subjects in each group to ensure that a difference of 0.5ºC at 60 minutes could be detected at significance level of 5% with a statistical power of 90%, assuming the standard deviation of differences to be 0.5ºC, considering a temperature below 36.0ºC could be considered hypothermia|||Centigrades||Standard Deviation|Mean
2607326|NCT02091440|Secondary|Change in Patient 6-minute Walk Distance (Patient Functional Status) at 6 and 24 Months|"For the 6-minute walk test, the patient is asked to walk for 6 minutes. The total distance walked is measured.~Values in the table were calculated as the value at Month 6 (180 days) minus Screening and at Month 24 (after FU completion) minus Screening.~A positive change in 6-minute walk distance indicates an improvement in health and functional status."|Screening, Month 6 (180 days) and Month 24 (after FU completion)||||Meters||Standard Deviation|Mean
2607327|NCT02091440|Secondary|Change in NYHA Patient Classification (Patient Functional Status) at 6 and 24 Months|"The New York Heart Association (NYHA) Functional Classification places patients with heart failure in one of four categories based on how much they are limited during physical activity.~Class I (best): No limitation of physical activity.~Class II: Slight limitation of physical activity. Comfortable at rest.~Class III: Marked limitation of physical activity. Comfortable at rest.~Class IV (worst): Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest.~A shift from a higher class (e.g. Class IV) to a lower class (e.g. Class II) indicates an improvement in patient health and functional status."|Screening, Month 6 (180 days) and Month 24 (after FU completion)||||Participants|||Count of Participants
2607328|NCT02091440|Secondary|Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Score at 6 and 24 Months|"The KCCQ is a self-evaluation questionnaire for patients with heart failure to assess the severity of their symptoms how it may affect their lives. Scores range between 0 (worst) - 100 (best).~Values in the table were calculated as the value at Month 6 (180 days) minus Screening and at Month 24 (after FU completion) minus Screening.~The positive change in KCCQ score indicates an improvement in patient Quality of Life."|Screening, Month 6 (180 days) and Month 24 (after follow-up (FU) completion)||||score on a scale||Standard Deviation|Mean
2607329|NCT02091440|Secondary|Incidence of All Device Failures and Device Malfunctions.|"The device failures and malfunctions are the failures on pumping function due to thrombosis inside/outside of the implanted pump, the mechanical failures of the implanted components, the mechanical failures of the external components and the failures due to the user.~Events were categorized using the J-MACS definitions."|Through study completion, an average of 44.5 months||||event rate per patient year|||Number
2607330|NCT02091440|Secondary|Incidence of All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs)|"SAEs are defined as events that result in death, are life-threatening, result in permanent disability, require medical treatment to prevent permanent disability or require surgical intervention or hospitalization.~UADEs are defined as any serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current version of the risk analysis report.~Events were categorized using the Japanese registry for Mechanically Assisted Circulatory Support (J-MACS) definitions."|Through study completion, an average of 44.5 months||||event rate per patient year|||Number
2607331|NCT02091440|Secondary|Number of Participants Alive on the Implanted HW005 Ventricular Assist System at 180 Days||180 days||||Participants|||Count of Participants
2607332|NCT02091440|Primary|Number of Participants Alive on the Implanted HW005 Ventricular Assist System or Transplanted or Explanted for Recovery at 180 Days|The primary endpoint is success at 180 days which is defined as alive on the originally implanted HW005 Ventricular Assist System or transplanted or explanted for recovery. Patients must survive 60 days post-explant for recovery to be considered successful.|180 days||||Participants|||Count of Participants
2607333|NCT02091414|Secondary|Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and During Treatment||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population|||percentage of participants|||Number
2607334|NCT02091414|Secondary|Percentage of Participants With Abnormal Serum Creatinine and BUN Values at Baseline and Normal Values During Treatment||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population|||percentage of participants|||Number
2607335|NCT02091414|Secondary|Percentage of Participants With Normal Serum Creatinine and BUN Values at Baseline and Abnormal Values During Treatment||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population|||percentage of participants|||Number
2607336|NCT02091414|Secondary|Percentage of Participants With Normal Serum Creatinine and Blood Urea Nitrogen (BUN) Values At Baseline (BL) And During Treatment||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population|||percentage of participants|||Number
2607337|NCT02091414|Secondary|Percentage of Participants Lost To Follow Up Within 24 Weeks of Transplantation||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population|||percentage of participants|||Number
2607338|NCT02091414|Secondary|Percentage of Participants Discontinuing Immunosuppressants (MMF) for More Than 14 Consecutive Days or 30 Cumulative Days Within 24 Weeks of Transplantation||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population|||percentage of participants||95% Confidence Interval|Number
2607339|NCT02091414|Secondary|Percentage of Participants Requiring Use of Additional Immunosuppressants Not Specified in the Protocol Within 24 Weeks of Transplantation||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population|||percentage of participants|||Number
2607340|NCT02091414|Secondary|Percentage of Participants With Graft Loss Within 24 Weeks of Transplantation||Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population|||percentage of participants|||Number
2607341|NCT02091414|Primary|Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) by Week|Percentage of participants with BPAR of greater than or equal to (≥) International Society of Heart and Lung Transplant (ISHLT) Grade III. The ISHLT graded symptoms on a scale of Grade 0 through VI. Grade 0 equals (=) no rejection. Grade IA = regional (perivascular or interstitial) infiltration and no necrosis, and grade IB = dissemination but little infiltration and no necrosis. Grade II = 1 focus of invasive infiltration with or without (+/-) associated cardiomyocyte necrosis. Grade IIIA = 2 or more foci of invasive infiltration +/- associated cardiomyocyte necrosis, and grade IIIB = diffuse inflammatory pathological changes associated with cardiomyocyte necrosis. Grade IV = diffuse, infiltrative multi-foci +/- edema; +/- hemorrhage; and +/-vasculitis.|Day 1, Weeks 1, 2, 4, 8, 12, 16, 20 and 24|ITT population|||percentage of participants||95% Confidence Interval|Number
2607342|NCT02091375|Secondary|Caregiver Global Impression Of Change (CGIC)|"The CGIC was used to assess the participant's overall condition on a 7-point scale using the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse, or very much worse (1 = very much improved; 7 = very much worse). On Day 1 (prior to starting IMP), the caregiver was asked to write a brief description of the participant's overall condition as a memory aid for the CGIC questionnaire at subsequent visits."|Baseline to Last Visit (Day 99) or ET|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||Participants|||Count of Participants
2607343|NCT02091375|Secondary|Change From Baseline In Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Score|The Vineland-II scores (standard scores and adaptive levels for each adaptive behavior domain, the adaptive behavior composite, and the maladaptive behavior index score and level) were assessed by the participant's caregiver. Scores were analyzed using an ANCOVA model with baseline and age group (2 to 5 years, 6 to 12 years, and 13 to 18 years) as covariates and treatment group as a fixed factor. Higher scores represent greater levels of functioning except for the maladaptive behavior index, for which a negative change from baseline represents an improvement in condition.|Baseline to Last Visit (Day 99) or ET|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||units on a scale||95% Confidence Interval|Least Squares Mean
2607389|NCT02090426|Other Pre-specified|Number of Readmissions|Outcome is the number of hospital readmissions within 365-days from index hospital discharge and is reported for the subset of participants for which sufficient time has passed that 365-day outcomes can be observed in hospital claims data.|365-day from indexed hospital discharge||2021-01-31|01/2021||||
2607390|NCT02090426|Other Pre-specified|Number of Readmissions||90-day from indexed hospital discharge||||readmissions||Standard Deviation|Mean
2607391|NCT02090426|Other Pre-specified|Number of Readmissions||30-day from indexed hospital discharge||||readmissions||Standard Deviation|Mean
2607344|NCT02091375|Secondary|Change From Baseline In Quality Of Life In Childhood Epilepsy (QOLCE) Score|The QOLCE questionnaire was completed by the parent or caregiver of participants aged 4 years and above. The change from baseline in the overall quality of life score was analyzed using an ANCOVA model with baseline and age group (2 to 5 years, 6 to 12 years and 13 to 18 years) as covariates and treatment group as a fixed factor. Zero represents the lowest or poorest category and 100 represents the highest level of functioning. The overall quality of life score was calculated by taking the mean of the subscale scores.|Baseline to EOT (Day 99) or ET|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||units on a scale||95% Confidence Interval|Least Squares Mean
2607345|NCT02091375|Secondary|Change From Baseline In Epworth Sleepiness Scale (ESS) Score|The ESS questionnaire was completed by the participant's caregiver. The change from baseline in the ESS score was analyzed using an ANCOVA model with baseline and age group (2 to 5 years, 6- to 2 years and 13 to 18 years) as covariates and treatment group as a fixed factor. The total score was the sum of the 8 item-scores and ranged from 0 to 24. A higher total score represents greater levels of daytime sleepiness.|Baseline to Last Visit (Day 99) or ET|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||units on a scale||95% Confidence Interval|Least Squares Mean
2607346|NCT02091375|Secondary|Change From Baseline In Sleep Disruption 0 To 10 Numerical Rating Scale (0 to 10 NRS) Score|The sleep disruption 0 to 10 NRS questionnaire was completed by the participant's caregiver. The caregiver was asked 'On a scale of '0 to 10', please indicate the number that best describes your child's sleep disruption in the last week.' The markers ranged from 0 = 'slept extremely well' to 10 = 'unable to sleep at all'. The change from baseline in the sleep disruption 0 to 10 numerical rating scale score was analyzed using an analysis of covariance (ANCOVA) model with baseline and age group (2 to 5 years, 6 to 12 years and 13 to 18 years) as covariates and treatment group as a fixed factor. A negative change from baseline represents an improvement in sleep. Last visit for endpoints assessed at clinic visits was defined as the last scheduled visit (not including the end of taper or safety follow-up visits) at which participant's last evaluation was performed.|Baseline to Last Visit (Day 99) or ET|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||units on a scale||95% Confidence Interval|Least Squares Mean
2607347|NCT02091375|Secondary|Number Of Participants With Inpatient Hospitalizations Due To Epilepsy|Inpatient hospitalizations due to epilepsy were recorded by the participant or caregiver and through the serious adverse events (SAE) reporting process.|Baseline to Safety Follow-up (Day 137)|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||participants|||Number
2607348|NCT02091375|Secondary|Number Of Participants Using Rescue Medication|The use of rescue medication was recorded by the participant or caregiver using a paper diary.|Baseline to EOT (Day 99) or ET|Safety Analysis Set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the actual treatment they received.|||Participants|||Count of Participants
2607349|NCT02091375|Secondary|Caregiver Global Impression Of Change In Seizure Duration (CGICSD)|"Seizure duration was assessed qualitatively using the CGICSD. Caregivers were asked Since the patient started treatment, please assess the average duration of the patient's seizures (comparing their condition now to their condition before treatment); responses included decrease, no change, or increase in average duration. For each seizure type, only participants with at least 1 seizure for the corresponding seizure type, reported at any time during the study, were included."|Baseline to EOT (Day 99) or ET|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||Participants|||Count of Participants
2607350|NCT02091375|Secondary|Percentage Change From Baseline In Non-Convulsive Seizure Frequency During The Treatment Period|Non-convulsive seizures (myoclonic, partial, or absence) were recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure. Only participants with non-convulsive seizures during the baseline period were included. Negative percentages show an improvement from baseline.|Baseline to EOT (Day 99) or ET|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||percent change||Inter-Quartile Range|Median
2607351|NCT02091375|Secondary|Number of Participants With A ≥25%, ≥75% Or 100% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period|Convulsive seizures (atonic, clonic, tonic, or tonic-clonic) were recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure.|Baseline to EOT (Day 99) or ET|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||Participants|||Count of Participants
2607352|NCT02091375|Secondary|Number Of Participants With A ≥50% Reduction From Baseline In Convulsive Seizure Frequency During The Treatment Period|Convulsive seizures (atonic, clonic, tonic, or tonic-clonic) were recorded by the participant or caregiver using an IVRS diary. Percentage change from baseline was calculated as per the primary outcome measure.|Baseline to EOT (Day 99) or ET|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||Participants|||Count of Participants
2607392|NCT02090426|Secondary|Hospital Receipts||180-day from indexed hospital discharge||||Hospital Receipts ($)||Standard Deviation|Mean
2607353|NCT02091375|Primary|Percentage Change From Baseline In Convulsive Seizure Frequency During The Treatment Period|Convulsive seizures (atonic, clonic, tonic, or tonic-clonic) were recorded by the participant or caregiver using an interactive voice response system (IVRS) diary. Percentage change from baseline was calculated as: ([frequency during the treatment period - frequency during baseline]/frequency during baseline) * 100. The frequency during each period was based on 28-day averages and calculated as: (number of seizures in the period/number of reported days in the IVRS period) * 28. Baseline included all available data prior to Day 1 (28-day average). Negative percentages show an improvement from baseline.|Baseline to End of Treatment (EOT) (Day 99) or Early Termination (ET)|ITT analysis set: included all participants in the Part B safety analysis set who had post-baseline efficacy data. Participants were analyzed according to the treatment group to which they were randomized. The ITT analysis set was the primary analysis set for all efficacy outcome measures.|||percent change||Inter-Quartile Range|Median
2607354|NCT02091362|Secondary|Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021|Population pharmacokinetic parameter, apparent volume of distribution (V/F) is a theoretical volume that a drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it currently is in blood plasma. Apparent volume of distribution (V/F) was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.|Days 7, 21, 42, 70, 77, 91, 112, 140; Predose and Days 7 and 77: 1 hour Postdose.|All randomized participants who received at least 1 one dose of study drug and had at least one measureable drug concentration.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2607355|NCT02091362|Secondary|Population Pharmacokinetics: Apparent Clearance of LY2409021|Population pharmacokinetic parameter apparent clearance (CL/F) is the apparent volume of the body fluid cleared of the drug per unit of time and was estimated by modeling of LY2409021 plasma concentration data from all LY2409021 groups.|Days 7, 21, 42, 70, 77, 91, 112, 140; 15 minute Predose and Days 7 and 77: 1 hour Postdose.|Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.|||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2607356|NCT02091362|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c)|LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.|Baseline, 6 Weeks|Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.|||percentage of HbA1c||95% Confidence Interval|Least Squares Mean
2607357|NCT02091362|Secondary|Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Mean Arterial Pressures (MAP)|Mean Arterial Pressures obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.|Baseline, 6 Weeks|Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.|||mmHg||95% Confidence Interval|Least Squares Mean
2607358|NCT02091362|Secondary|Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Pulse Pressures|Pulse Pressures obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.|Baseline, 6 Weeks|Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.|||mmHg||95% Confidence Interval|Least Squares Mean
2607359|NCT02091362|Secondary|Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Peripheral Pulse Rate|Pulse rate obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.|Baseline, 6 Weeks|Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.|||beats/minute||95% Confidence Interval|Least Squares Mean
2607360|NCT02091362|Secondary|Change From Baseline to 6 Weeks in Mean 24-Hour Diastolic Blood Pressure|Diastolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM). LS Mean of treatment differences, adjusted for country, diagnosis of hypertension, sequence, treatment, period, time within period, treatment by time within period interaction, and the baseline measurement as covariate.|Baseline, 6 Weeks|Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.|||mmHg||95% Confidence Interval|Least Squares Mean
2607361|NCT02091362|Primary|Change From Baseline to 6 Weeks in Mean 24-Hour Systolic Blood Pressure|Systolic blood pressure obtained from Ambulatory Blood Pressure Monitoring (ABPM).|Baseline, 6 Weeks|Modified intent-to-treat (mITT) population consisting of all randomized subjects who received at least one dose of study drug.|||mmHg||95% Confidence Interval|Least Squares Mean
2607362|NCT02091284|Other Pre-specified|Changes in Quality of Life of the World Health Organization (WHOQOL-BREF)|An abbreviated instrument of cross-culturally valid assessment of quality of life of the World Health Organization (WHOQOL-BREF) with 26 questions translated to Portuguese was applied at the beginning and at the end of the five-week treatment. This instrument yields four domains (physical health, psychological, social relationships and environment) and two individually scored items regarding overall perception of quality of life (Q1, i.e., first question) and health (Q2, i.e., second question). The four domain scores are scaled in a way that higher scores stand for higher quality of life. These scores were transformed to be comparable with the scores used in the WHOQOL-100.|Before tDCS treatment (initial) and after the end of the tDCS treatment (final)|These data was not collected correctly.||||||
2607363|NCT02091284|Other Pre-specified|Changes in Event-Related Potentials (ERPs)|"Electrophysiological recording was obtained through a 32-channel system placed on the scalp according to the International 10/20 EEG system.~A cue-reactivity paradigm was adapted following standard cue-reactivity paradigms well established for pictures and videos. During picture presentation the subjects were asked to press a button whenever the drug-related pictures were presented, and to withhold the response when the neutral pictures were presented (50% of the time). The percent change of ventral medial Prefrontal Cortex current density was analyzed."|Before tDCS treatment (initial) and after the end of the tDCS treatment (final)|ERP data was not possible in the total sample of each group because of technical difficulties.|||percent change||Standard Deviation|Mean
2607364|NCT02091284|Other Pre-specified|Changes in Hamilton Anxiety Rating Scale (HAM-A)|A structured multiple-choice questionnaire designed to assess the severity of anxiety symptoms was employed. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (e.g., mental agitation and psychological distress) and somatic anxiety (e.g., physical complaints related to anxiety). The higher the scores, higher the severity. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where below 17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.|Before tDCS treatment (initial) and after the end of the tDCS treatment (final)||||scores||Standard Deviation|Mean
2607365|NCT02091284|Other Pre-specified|Changes in Hamilton Depression Rating Scale (HAM-D)|A structured multiple-choice questionnaire was used to assess the severity of depression symptoms. This instrument assesses the severity of symptoms observed in depression, such as low mood, insomnia, agitation, anxiety and weight loss (Hamilton, 1960). Each question has between 3 and 5 possible answers that increase in severity. In the original scale, the first 17 questions contribute to the total score, while questions 18 to 21 provide additional information about depression (e.g., diurnal variation, paranoid symptoms), but are not included in the total score of the scale. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score is 52.|Before tDCS treatment (initial) and after the end of the tDCS treatment (final)||||scores||Standard Deviation|Mean
2607366|NCT02091284|Other Pre-specified|Changes in Mini-Mental Status Examination (MMSE)|An adapted version of the MMSE in Portuguese was used. This version included an 11-item examination that examined five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score, meaning better scores, that could be achieved was 30, while a mean score between 23 and 26 or between 26 and 29 would be expected according to the age and educational level of the alcoholics.|Before tDCS treatment (initial) and after the end of the tDCS treatment (final)||||scores||Standard Deviation|Mean
2607367|NCT02091284|Other Pre-specified|Changes in Frontal Assessment Battery (FAB) Scores|The FAB was used to explore six different domains of executive function. Each of these items is scored from 0 (zero) to a maximum of 3. Thus, the maximum score, meaning better scores, of FAB is 18. A single well trained examiner administered this assessment.|Before tDCS treatment (initial) and after the end of the tDCS treatment (final)||||scores||Standard Deviation|Mean
2607368|NCT02091284|Primary|Craving|Five items from the original obsessive compulsive drinking scale, which are believed to reliably assess craving in a narrow sense were used. Questions of this brief scale allow quantification of thoughts and feelings (obsessions), and behavioral intentions, and are answered on a scale ranging from 0 to 4, resulting in a total score between 0 and 20. Higher scores reflect more severe craving. These items were applied at the beginning, during and at the end of the treatment with sham-tDCS or tDCS.|Five applications: first week before tDCS treatment (baseline), second, third and fourth weeks, during the treatment, and in the fifth week, after the end of the tDCS treatment.||||scores||Standard Deviation|Mean
2607369|NCT02091206|Secondary|Mean Percentage Change From Baseline To End Of Treatment In Plasma Clobazam (CLB) And N-Desmethylclobazam (N-CLB) Concentrations|Plasma concentrations of CLB and N-CLB were measured on Days 1 and 22. Participants were instructed to take their daily dose of CLB 2 hours prior to the anticipated pre-IMP blood specimen collection on both days. Blood samples were collected prior to administration of IMP. Results are presented for a subgroup of participants who took CLB during the study and had PK samples analyzed at both PK sampling visits (Days 1 and 22).|Predose on Days 1 and 22|Safety analysis set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.|||percent change|||Number
2607370|NCT02091206|Secondary|Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22|AUC0-t for CBD and its major metabolites, 6-hydroxy-CBD (6-OH-CBD), 7-hydroxy-CBD (7-OH-CBD), and 7-carboxy-CBD (7-COOH-CBD) were calculated using blood samples collected before and after IMP dosing on Days 1 and 22. One sample was collected predose, 2 to 3 hours postdose, and 4 to 6 hours postdose for CBD and its metabolites. Results are presented for participants who received GWP42003-P at 5, 10, or 20 mg/kg/day during the study and for participants with a numeric result for the given evaluation.|Predose and 2-6 hours postdose on Days 1 and 22|Safety analysis set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.|||hours * nanograms/mL||Geometric Coefficient of Variation|Geometric Mean
2607371|NCT02091206|Primary|Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)|"A TEAE was defined as an adverse event (AE) with an onset date on or after the first dose of IMP. If an AE had a partial onset date and it was unclear from the partial date (or the stop date) whether the AE started prior to or following the first dose of IMP then the AE was considered a TEAE. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through the Safety Follow-up Visit (Day 60) is presented.~A summary of serious and all other non-serious AEs regardless of causality is located in the Adverse Events module."|Baseline (Day 1) through Safety follow-up visit (Day 60)|Safety analysis set: included all participants randomized to treatment who received at least 1 dose of IMP. Participants were analyzed according to the treatment they received. Only participants for whom it had been confirmed that they did not take any IMP were excluded from the safety analysis set.|||Participants|||Count of Participants
2607372|NCT02091167|Primary|Relapses|A use relapse was defined as the first episode of return to the previous uncontrolled pattern of crack-cocaine use (rocks per day). Information about relapse were gathered directly when patients regularly returned to the hospital for clinical follow-up after their discharge and/or by self-report or reports of family members by telephone calls.|30 and 60 days after discharge from clinics||||Participants|||Count of Participants
2607393|NCT02090426|Secondary|Hospital Charges||180-day from indexed hospital discharge||||hospital charges ($)||Standard Deviation|Mean
2607394|NCT02090426|Secondary|Number of Days in the Hospital||180-day from indexed hospital discharge||||days in hospital||Standard Deviation|Mean
2607395|NCT02090426|Secondary|Had 2+ Readmissions||180-day from indexed hospital discharge||||Participants|||Count of Participants
2607373|NCT02091167|Primary|Craving|"Five items from the original obsessive compulsive drinking scale, which are believed to reliably assess craving in a narrow sense were used. Questions of this brief scale allow quantification of thoughts and feelings (obsessions), and behavioral intentions, and are answered on a scale ranging from 0 to 4, resulting in a total score between 0 and 20.~Higher scores reflect more severe craving. These items were applied at the beginning, during and at the end of the treatment with sham-tDCS or tDCS."|Five applications: once in the week before tDCS treatment (baseline), second, third and fourth weeks, during the treatment, and in the fith week, after the end of the tDCS treatment.|Two patients from each group were lost to follow-up after their discharge from the hospital.|||scores on a scale||Standard Deviation|Mean
2607374|NCT02090894|Secondary|Relative Level of IGF-1 mRNA in the Skin|IGF-1 mRNA per 100,000 beta-2 microglobulin mRNA. Beta-2 microglobulin mRNA was used as a reference gene for this assessment and that the data represent number of copies IGF-1/100,000 copies b2-microglobulin.|untreated and LaserGenesis treated, three months after treatment|untreated and laser treated biopsies were taken from each subject|||relative mRNA||Standard Error|Mean
2607375|NCT02090894|Primary|Difference in Basal Layer Keratinocytes Positive for Both Ki67 and Thymine Dimers|Number of double positive cells per 1000 total basal layer keratinocytes|untreated and LaserGenesis treated, three months after treatment, 24 hours after 350 J/m2 of UVB|untreated and laser treated biopsies were taken from each subject|||positive cells/1000 basal layer cells||Standard Deviation|Mean
2607376|NCT02090855|Secondary|Specificity Percentage of Blinded Visual PET Image Interpretations|Specificity of blinded visual image interpretations according to neuropathological criteria, which is defined as the neuritic plaque density, neurofibriilary tangles and vasculpoathy in the brain.|Brain images will be assessed up to 1 year post subject's death.|There are 30 autopsy cases confirmed to be normal. The majority interpretation is the interpretation made independently by more than half of the readers.|||Percentage of Specificity|||Number
2607377|NCT02090855|Primary|Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans|Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program.|Brain images will be assessed up to 1 year post subject's death.|There are 76 autopsy cases confirmed to be abnormal. The majority interpretation is the interpretation made independently by more than half of the readers.|||Percent of Sensitivity|||Number
2607378|NCT02090855|Secondary|Number of Blinded Visual PET Image Interpretations|Specificity of blinded visual image interpretations according to neuropathological criteria.|Brain images will be assessed up to 1 year post subject's death.|There are 30 autopsy cases confirmed to be normal. The majority interpretation is the interpretation made independently by more than half of the readers.|||Number of Blinded Image Intrepretations|||Number
2607379|NCT02090855|Primary|The Number of Abnormal Blinded Visual PET Image Interpretations.|Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program.|Brain images will be assessed up to 1 year post subject's death.|There are 76 autopsy cases confirmed to be abnormal. The majority interpretation is the interpretation made independently by more than half of the readers.|||Number of Blinded Image Interpretations|||Number
2607380|NCT02090777|Primary|Glaucoma Medication Adherence|Glaucoma medication adherence will be tracked using a dose recording device to record eye drop usage. The average of the participants percentage of time they adhered to using the medication will be reported.|6 Months||||percentage of adherence time||Standard Deviation|Mean
2607381|NCT02090764|Primary|Clinical Success|"Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population.~Clinical success at V3 was defined as: SIRS score 0 for blistering, exudates/pus, crusting and itching/pain and no more than 1 for erythema/inflammation such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary.~The skin infection rating scale (SIRS) is a severity index based on five signs or symptoms: blistering, exudate/pus, crusting, erythema/inflammation, itching/pain."|Visit 3 (Day 6-7)|"Intent-to-treat clinical (ITTC) population was defined as all randomized patients.~The % of clinical success for the treatment comparison were calculated excluding the unable to determine: OZN (112/203), PLB (78/199)"|||percentage of Participants|||Number
2607382|NCT02090725|Primary|Number of Participants That Showed Improvement in Muscle Weakness During Their Last Study Related Visit|Muscle weakness will be assessed monthly for the first 3 months based on clinical assessment during office visits. Muscle weakness will then be assessed every 6 months once the patient is stabilized based on clinical assessments during office visits. The assessment of whether there was an improvement in muscle weakness, based on the PI's clinical judgment, was noted during the last study visit completed by the participant.|Participants were followed until they withdrew or the study ended. Time frame ranged from 1 month to 3 years.|One participant was not on the study long enough to complete the one month assessment.|||Participants|||Count of Participants
2607383|NCT02090426|Other Pre-specified|Number of Readmissions (for Non-English Speaking Patients)||180-day from indexed hospital discharge|Pre-specified subset of non-English speaking patients who completed the 180-day primary outcome period.|||readmissions||Standard Deviation|Mean
2607384|NCT02090426|Other Pre-specified|Number of Readmissions (for English Speaking Patients)||180-day from indexed hospital discharge|Pre-specified subset of English-speaking patients who completed the 180-day primary outcome period.|||readmissions||Standard Deviation|Mean
2607385|NCT02090426|Other Pre-specified|Number of Readmissions (for Patients With 2 Readmissions in the Prior Year)||180-day from indexed hospital discharge|Pre-specified subset of patients with 2 readmissions in the prior year who completed the 180-day primary outcome period.|||readmissions||Standard Deviation|Mean
2607386|NCT02090426|Other Pre-specified|Number of Readmissions (for Patients With 3+ Readmissions in the Prior Year)||180-day from indexed hospital discharge|Pre-specified subset of patients with 3+ readmissions in the prior year who completed the 180-day primary outcome period.|||readmissions||Standard Deviation|Mean
2607387|NCT02090426|Other Pre-specified|Time to Readmission (Days)|Outcome is the number of days until readmission for the subset of participants for which sufficient time has passed that 365-day outcomes can be observed in hospital claims data and who had a readmission within 365 days.|Up to 365 days from indexed hospital discharge||2021-01-31|01/2021||||
2607402|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-VAS|"For the EQ-VAS, the participant was instructed to draw a line on a 20-cm vertical scale at the point that best describes his or her own health, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state."|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2607403|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Anxiety/Depression|"EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has no problems (1), some problems (2), or severe problems (3). A negative change from Baseline indicates improvement."|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2607404|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Pain/Discomfort|"EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has no problems (1), some problems (2), or severe problems (3). A negative change from Baseline indicates improvement."|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2607405|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Usual Activities|"EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has no problems (1), some problems (2), or severe problems (3). A negative change from Baseline indicates improvement."|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2607406|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the EQ-5D-5L Questionnaire: Self-Care|"EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-VAS. The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has no problems (1), some problems (2), or severe problems (3). A negative change from Baseline indicates improvement."|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2607407|NCT02090413|Secondary|Change From Baseline to Week 24 and Week 48 in Quality of Life Measurements as Assessed by the European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) Questionnaire: Mobility|"EQ-5D-5L is a standardized, subject-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-Visual Analog Scale (EQ-VAS). The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to indicate whether he or she has no problems (1), some problems (2), or severe problems (3). A negative change from Baseline indicates improvement."|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2607408|NCT02090413|Secondary|Change From Baseline at Weeks 24 and 48 in Quality of Life Measurements as Assessed by Short Form-36 (SF-36) Questionnaire: Mental Component Summary (MCS)|SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health. The score for a domain is an average of the individual question scores, which are scaled 0 (worst health-related quality of life) to 100 (best health-related quality of life). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0 (lowest level of physical functioning) to 100 (highest level of physical functioning).|Baseline, Week 24, Week 48 or ET|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2607418|NCT02090413|Secondary|Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MGFSS|Worst severity of participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.|||units on a scale||Standard Deviation|Mean
2607409|NCT02090413|Secondary|Change From Baseline at Weeks 24 and 48 in Quality of Life Measurements as Assessed by Short Form-36 (SF-36) Questionnaire: Physical Component Summary (PCS)|SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health. The score for a domain is an average of the individual question scores, which are scaled 0 (worst health-related quality of life) to 100 (best health-related quality of life). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0 (lowest level of physical functioning) to 100 (highest level of physical functioning).|Baseline, Week 24, Week 48 or early termination (ET)|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2607410|NCT02090413|Secondary|Number of Participants Discontinuing Treatment and Discontinuing the Study Due to Treatment-Emergent Flushing AEs in Weeks 13 to 48|A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug. Flushing AEs include redness, warmth, tingling, and/or itching of the skin.|Week 13 to Week 48|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).|||participants|||Number
2607411|NCT02090413|Secondary|Number of Participants Discontinuing Treatment and Discontinuing the Study Due to Treatment-emergent Flushing AEs in the First 12 Weeks|A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug. Flushing AEs include redness, warmth, tingling, and/or itching of the skin.|Day 1 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).|||participants|||Number
2607412|NCT02090413|Secondary|Number of Participants Experiencing Treatment-Emergent AEs, SAEs, and Discontinuations Due to AEs in Weeks 13 to 48|AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity, or; results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug.|Week 13 to Week 48|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).|||participants|||Number
2607413|NCT02090413|Secondary|Number of Participants Experiencing Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs in the First 12 Weeks|AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity, or; results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above. A treatment-emergent AE is defined as any AE that occurs after the first administration of DMF or ASA/Placebo drug.|Day 1 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).|||participants|||Number
2607414|NCT02090413|Secondary|Number of Participants With Self-Reported Flushing Events During Weeks 13 to 48|Participant-reported flushing events (which include redness, warmth, tingling, and/or itching of the skin) during Weeks 13 to 48 of treatment were recorded in the CRF.|Week 13 to Week 48|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).|||participants|||Number
2607415|NCT02090413|Secondary|Duration of Flushing Episodes During Weeks 1-4, 5-8 and 9-12 of the Study, as Assessed by MFSS|Duration of participant-reported flushing events during weeks 1-4, 5-8 and 9-12 of the study recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). For participants with more than 1 flushing event during a visit interval, the average duration for the visit interval was used.|Day 1 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.|||hours||Standard Deviation|Mean
2607416|NCT02090413|Secondary|Duration of Flushing Episodes During Weeks 1-4, 5-8 and 9-12 of the Study, as Assessed by MGFSS|Duration of participant-reported flushing events during weeks 1-4, 5-8 and 9-12 of the study recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 12|Although designated as a secondary endpoint, the duration of flushing events based on MGFSS could not be calculated because specific flushing events with start and end times was not captured in the MGFSS.||||||
2607417|NCT02090413|Secondary|Worst Severity Scores of Overall Flushing During Weeks 5-8 and Weeks 9-12 of the Study, as Assessed by MFSS|Worst severity of participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.|||units on a scale||Standard Deviation|Mean
2607419|NCT02090413|Secondary|Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MFSS|Participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).|||percentage of participants|||Number
2607420|NCT02090413|Secondary|Percentage of Participants Reporting Overall Flushing Events During Weeks 5-8 and Weeks 9-12 of Treatment, as Assessed by MGFSS|Participant-reported flushing events during Weeks 5-8 and Weeks 9-12 of the study recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 12|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug). n=number of evaluable participants at given time period.|||percentage of participants|||Number
2607421|NCT02090413|Primary|Worst Severity Scores of Overall Flushing During the First 4 Weeks of Treatment, as Assessed by MFSS|Worst severity of participant-reported flushing events during the first 4 weeks of treatment recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 4|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).|||units on a scale||Standard Deviation|Mean
2607422|NCT02090413|Primary|Worst Severity Scores of Overall Flushing During the First 4 Weeks of Treatment, as Assessed by MGFSS|Worst severity of participant-reported flushing events during the first 4 weeks of treatment recorded on the eDiary as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.|Day 2 to Week 4|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).|||units on a scale||Standard Deviation|Mean
2607423|NCT02090413|Primary|Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Flushing Severity Scale (MFSS)|Participant-reported flushing events during the first 4 weeks of treatment recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 4|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug).|||percentage of participants|||Number
2607424|NCT02090413|Primary|Percentage of Participants Reporting Overall Flushing Events During the First 4 Weeks of Treatment, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)|Participant-reported flushing events during the first 4 weeks treatment, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.|Day 2 to Week 4|Evaluable participants in the Safety Population (randomized participants who received at least 1 dose of study drug); n=number of participants evaluable at given time point.|||percentage of participants|||Number
2607425|NCT02090283|Secondary|Change From Baseline In Body Surface Area Index (BSAI) Of Lesional Skin At Month 24|Lesional skin was defined as areas that contained any of the following: blisters, erosions, ulcerations, scabbing, bullae, or eschars, as well as areas that were weeping, sloughing, oozing, crusted, or denuded. The percentage, ranging from 0% to 100%, of affected body surface area (BSA) was recorded for each defined body region (that is, head/neck, upper limbs, trunk [includes groin], and lower limbs), multiplied by the weighting factor, and then summed for all body regions to calculate the BSAI. The BSA for lesional skin was to be assessed by the same study physician on each visit for a particular participant. The mean change from baseline (final visit from the SD-003 study) in BSAI was assessed every 3 months. Only participants with data available for analysis at the specified time point are presented.|Baseline, Month 24|Intent to Treat: All participants who successfully rolled over into the SD-004 study from the SD-003 study and applied/were administered at least 1 dose of study drug.|||percentage of BSAI||Standard Deviation|Mean
2607426|NCT02090283|Primary|Number Of Participants With Treatment-Emergent Adverse Events (TEAEs)|Treatment-emergent adverse events were defined as adverse events that started or worsened on or after baseline visit, which occurred at the final visit date for the SD-003 study. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|From baseline to 30 days after last application of study drug (up to a maximum of 54 months)|Safety: All participants who successfully rolled over into the SD-004 study from the SD-003 study and applied/were administered at least 1 dose of study drug.|||Participants|||Count of Participants
2607427|NCT02090088|Secondary|Number of Participants With Adverse Events||Throughout pregnancy and for up to 6 weeks after delivery|All enrolled participants|||participants|||Number
2607428|NCT02090088|Secondary|Number of Infants With Adverse Events|In the first year of life, the incidence of all serious adverse events, as well as of nevi (birthmarks) and angiomata (benign tumors with blood vessels or lymph vessels), among infants whose mothers received Nplate® therapy at any time during the pregnancy.|12 months from birth|Children born to enrolled participants during the study|||infants|||Number
2607429|NCT02090088|Secondary|Number of Children Born With Intrauterine Growth Restriction|Number of children born with intrauterine growth restriction (weight, length or head circumference less than tenth percentile for sex and gestational age) among mothers who have received Nplate® therapy at any time during the pregnancy.|At birth|Children born to enrolled participants during the study|||children|||Number
2607430|NCT02090088|Secondary|Number of Children With Preterm Birth or Low Birth Weight|Number of children with preterm birth (<37 weeks gestation) or low birth weight (<2,500 grams) among children born to mothers who have received Nplate® therapy at any time during the pregnancy.|At birth|Children born to enrolled participants during the study|||children|||Number
2607431|NCT02090088|Secondary|Number of Participants With Spontaneous and Elective Abortions or Stillbirths|Number of each of spontaneous abortions, elective abortions, and stillbirths among mothers who received Nplate® therapy at any time during the pregnancy.|9 months (during pregnancy)|All enrolled participants|||participants|||Number
2607432|NCT02090088|Secondary|Number of Children Born With a Specific Pattern of Minor Birth Defects|"Only those infants who have received medical evaluation and who have three or more minor defects will be considered affected for purposes of the evaluation of a pattern of minor defects."|At birth|Children born with 3 or more minor birth defects||||||
2607433|NCT02090088|Secondary|Number of Children Born With Any 3 or More Minor Birth Defects|An external, independent Congenital Malformation Adjudication Panel (CMAP) comprised of two clinical dysmorphologists and/or teratologists organized malformations based upon organ system and embryology, and determined whether structural defects were major or minor according to a modification of the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system. A minor structural defect is defined as a defect which occurs in less than 4% of the population but which has neither cosmetic nor functional significance to the child (eg, complete 2,3 syndactyly of the toes).|At birth|Children born to enrolled participants during the study|||children|||Number
2607434|NCT02090088|Primary|Number of Children Born With Major Birth Defects|An external, independent Congenital Malformation Adjudication Panel (CMAP) comprised of two clinical dysmorphologists and/or teratologists organized malformations based upon organ system and embryology, and determined whether structural defects were major or minor according to a modification of the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system. A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (eg, a cleft lip), require surgery, or are life-limiting).|At birth|Children born to enrolled participants during the study|||children|||Number
2607435|NCT02090075|Secondary|Coronary Plaque on CT Angiography|To evaluate if treatment with apixaban therapy, as compared to warfarin therapy, will modify the progression, regression and stabilization of coronary atherosclerosis. Modifications will include differences in plaque volume, composition and arterial remodeling; as well as new atherosclerosis formation. The scale is based upon volume of plaque in the coronary arteries, with zero being no plaque and a higher number being more plaque. There is no scale or maximum measure, this is a linear measure of atherosclerosis volume in the coronary arteries and more is worse. None is best, any plaque is considered worse, and a higher plaque volume represents more atherosclerosis. An individual of average health will have a score of 50.|1 year|all participants with follow up data|||units on a scale||Standard Deviation|Mean
2607436|NCT02090075|Primary|Coronary Artery Calcium (CAC) Score|amount of calcification measured by Agatston Score. The range of values for the Agatston score is 0-10000. Higher score is worse outcome.|1 year|all with follow up scans|||units on a scale||Standard Deviation|Mean
2607437|NCT02089997|Secondary|Number of Participants Who Had Lumbar Backache at Final Assessment||Final assessment (Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.|||Participants|||Number
2607438|NCT02089997|Secondary|Change From Baseline in Height||Baseline and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.|||Centimeter||Standard Deviation|Mean
2607439|NCT02089997|Secondary|Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment|Urine samples for urinary bone turnover markers were collected at specified visits according to the study schedule.|Baseline and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
2607440|NCT02089997|Secondary|Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment|Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.|Baseline and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
2607441|NCT02089997|Secondary|Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment|Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.|Baseline and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
2607442|NCT02089997|Secondary|Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment|Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.|Baseline and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
2607443|NCT02089997|Secondary|Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment|Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.|Baseline and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
2607444|NCT02089997|Secondary|Percent Change From Baseline in Radius BMD at Final Assessment|BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the radius at end of study relative to baseline.|Baseline and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
2607445|NCT02089997|Secondary|Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment|BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at end of study relative to baseline.|Baseline and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
2607446|NCT02089997|Secondary|Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment|BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the femur (neck region) at end of study relative to baseline.|Baseline and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
2607447|NCT02089997|Secondary|Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment|BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline.|Baseline and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed are participants evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
2607448|NCT02089997|Primary|Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of sodium risedronate, whether or not it was considered related to the treatment.|Up to Month 12|Safety Analysis Set was defined as all participants who were enrolled and completed the study.|||Participants|||Number
2607449|NCT02089737|Secondary|Overall Survival|Overall survival was defined as the time to death from the start of panitumumab administration was tabulated.|Up to Week 42 or death (whichever occurred first)|All participants that received panitumumab monotherapy as a third-line or later therapy.|||weeks||95% Confidence Interval|Median
2607450|NCT02089737|Secondary|Progression-free Survival|Progression-free Survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.|Up to Week 42 or death (whichever occurred first)|Participants who were included in the efficacy analysis set and received panitumumab monotherapy as a third-line or later therapy.|||Months||95% Confidence Interval|Median
2607451|NCT02089737|Primary|Number of Participants With Adverse Drug Reactions|The number of participants with adverse drug reactions reported during the observation period were tabulated by type, seriousness, and time of onset. . Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.|Baseline through Week 42|Of the 3086 participants who completed the survey form, 3085 participants were included in the safety analysis set after excluding 1 participant for whom information regarding panitumumab treatment and adverse events were missing.|||Participants|||Number
2607452|NCT02089659|Primary|Plasma Concentration of Doravirine at 24 Hours (C24)|Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method|24 hours postdose|The analysis population consisted of the subset of participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||nM||95% Confidence Interval|Geometric Mean
2607453|NCT02089659|Primary|Area Under the Plasma Concentration Versus Time Curve Form 0 to 24 Hours (AUC0-24) of Doravirine|Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method|Predose and at 0.5, 1, 1.5, 2, 3, 6, 12, and 24 hours postdose|The analysis population consisted of the subset of participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||µM*hr||95% Confidence Interval|Geometric Mean
2607454|NCT02089659|Primary|Maximum Observed Plasma Concentration (Cmax) of Doravirine|Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method|Predose and at 0.5, 1, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours postdose for all participants and at 96, 120, and 144 hours postdose for participants with hepatic insufficiency|The analysis population consisted of the subset of participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||nM||95% Confidence Interval|Geometric Mean
2607491|NCT02088216|Secondary|Change of Forced Vital Capacity (FVC) From Baselines|The change was calculated from two time points as the value at the later time point minus the value at the earlier time point.|12 months||||L||Standard Deviation|Mean
2607455|NCT02089659|Primary|Area Under the Plasma Concentration Versus Time Curve From 0 Hours to Infinity (AUC0-∞) of Doravirine|Blood was collected for the determination of plasma doravirine using a liquid chromatographic tandem mass spectrometric method|Predose and at 0.5, 1, 1.5, 2, 3, 6, 12, 24, 48, and 72 hours postdose for all participants and at 96, 120, and 144 hours postdose for participants with hepatic insufficiency|The analysis population consisted of the subset of participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||µM*hr||95% Confidence Interval|Geometric Mean
2607456|NCT02089347|Secondary|Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine|Solicited injection-site: Pain, Erythema, Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection-site: Pain Significant, prevents daily activity; Erythema and Swelling >100 mm. Grade 3 systemic reactions: Fever, >39˚C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection-site reactions and systemic reactions were assessed in the Safety Analysis Set.|||Percentage of Participants|||Number
2607457|NCT02089347|Secondary|Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine|Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric Mean Concentration was assessed in the per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
2607458|NCT02089347|Secondary|Percentage of Participants With Pertussis (Pertactin and Fimbriae Types 2 and 3) Booster Response Following Vaccination With Either SP306 or DT Vaccine|"Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post-vaccination level ≥ 4XLLOQ; or a pre-vaccination antibody concentration ≥ LLOQ but < 4XLLOQ and a 4-fold rise (i.e. post/pre-vaccination ≥ 4); or a pre-vaccination antibody concentrations ≥ 4XLLOQ and a 2-fold rise (i.e. post/pre-vaccination ≥2).~Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method."|Day 28 post-vaccination|Post-vaccination pertussis booster response was determined in the per-protocol population|||Percentage of Participants|||Number
2607459|NCT02089347|Secondary|Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine|Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric Mean Concentration were assessed in the per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
2607460|NCT02089347|Secondary|Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT Vaccine|"Seroprotection was defined as the proportion of participants with diphtheria and tetanus antitoxin concentration level ≥ 0.01 IU/mL.~Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method."|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection was assessed in the per-protocol population|||Percentage of Participants|||Number
2607461|NCT02089347|Secondary|Percentage of Participation With Seroprotection to Diphtheria and Tetanus Antigens Before Vaccination With Either SP306 or DT Vaccine|"Seroprotection was defined as the proportion of participants with pre-vaccination with diphtheria and tetanus antitoxin concentration ≥ 0.1 IU/mL.~Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method."|Pre-vaccination (Day 0)|Seroprotection was assessed in the per-protocol population|||Percentage of Participants|||Number
2607462|NCT02089347|Primary|Percentage of Participants With Pertussis Booster Response Following Vaccination With Either SP306 or DT Vaccine|"Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post vaccination level ≥ 4XLLOQ; or a pre-vaccination antibody concentration ≥ LLOQ but < 4XLLOQ and a 4-fold rise (i.e. post/pre-vaccination ≥ 4); or a pre-vaccination antibody concentrations ≥ 4XLLOQ and a 2-fold rise (i.e. post/pre-vaccination ≥2).~Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method."|Day 28 post-vaccination|Post-vaccination pertussis booster response was determined in the per-protocol population|||Percentage of Participants|||Number
2607463|NCT02089347|Primary|Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Post-booster Vaccination With Either SP306 or DT Vaccine|"Seroprotection was defined as the proportion of subjects at 28 days post-vaccination with diphtheria and tetanus antitoxin concentration ≥0.1 IU/mL.~Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method"|Day 28 post-vaccination|Seroprotection was assessed in the per-protocol population|||Percentage of Participants|||Number
2607464|NCT02089347|Primary|Percentage of Participants With Diphtheria and Tetanus Post-vaccination Booster Response Following Vaccination With Either SP306 or DT|"Diphtheria booster response was defined as a ≥4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration >2.56 IU/mL. A tetanus booster response is defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration >2.7 IU/mL.~Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method"|Day 28 post-vaccination|Post-vaccination booster response was determined in the per-protocol population|||Percentage of Participants|||Number
2607465|NCT02089191|Secondary|Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear|The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The slope of the regression line (distorted areas vs. time) was calculated. A slower speed (higher number) indicates a more stable tear film. The right eye was evaluated.|Hour 12|This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan.|||percent distortion per second||Standard Deviation|Mean
2607466|NCT02089191|Primary|Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear|The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The time to 15% destabilization of the tear film was calculated. A longer time indicates a more stable tear film. The right eye was evaluated.|Day 1, Hour 12, each period|This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan.|||seconds||Standard Deviation|Mean
2607467|NCT02089113|Primary|Number of Participants With an Absence of Ocular Pain|Absence of pain (i.e., score of '0') in the study eye at Day 8|Day 8||||participants|||Number
2607468|NCT02089113|Primary|Number of Participants With an Absence of Anterior Chamber Inflammation|Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14|Day 14||||participants|||Number
2607469|NCT02088957|Secondary|Time to First Onset of Seizure Cessation Relative to the Start of the First Acute Intravenous (iv) Administration|Seizure cessation is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From start of first acute iv administration|This variable was not analyzed and no results are available.||||||
2607470|NCT02088957|Secondary|Percentage of Subjects Requiring a Second Acute Intravenous (iv) Administration Between 15 Minutes to 12 Hours After First Acute iv Administration||Between 15 minutes to 12 hours after first acute iv administration|This variable was not analyzed and no results are available.||||||
2607471|NCT02088957|Secondary|Time to Achievement of 12 Hours of Seizure Freedom Relative to the Start of the Last Acute Intravenous (iv) Administration That Occurred Prior to the Initiation of Bid (Twice a Day) Dosing|Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From start of last acute iv administration prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)|This variable was not analyzed and no results are available.||||||
2607472|NCT02088957|Secondary|Time to Achievement of 12 Hours of Seizure Freedom Relative to the Start of the First Acute Intravenous (iv) Administration|Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From start of first acute iv administration on Day 1|This variable was not analyzed and no results are available.||||||
2607473|NCT02088957|Secondary|Percentage of Subjects With Seizure Freedom for 12 Hours Based on cEEG/vEEG Monitoring Which Starts After the End of the Last Acute Intravenous (iv) Administration of Study Drug and Prior to the Initiation of Bid (Twice a Day) Dosing|Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From end of the last acute iv administration of study drug and prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)|This variable was not analyzed and no results are available.||||||
2607474|NCT02088957|Primary|Percentage of Subjects With Seizure Freedom for 12 Hours Based on cEEG/vEEG Monitoring Which Starts 1 Hour After the End of the Last Acute iv Administration of Study Drug and Prior to the Initiation of Bid (Twice a Day) Dosing|Seizure freedom is based on cEEG/vEEG (continuous video electroencephalogram) monitoring.|From 1 hour after end of the last acute iv administration of study drug and prior to initiation of bid dosing (which begins 12 hours after the last acute iv administration of study drug)|This variable was not analyzed and no results are available.||||||
2607475|NCT02088905|Secondary|Parental Stress Index Score|Parental Stress Index-4 Short Form (PSI):Total Stress Scale, total of subscales, range 36-180, higher indicating more parental stress. Defensive Responding, range 7-35. Lower scores indicate higher defensive responding from parents. Parental Distress, range 12-60. Higher scores indicate more parental stress. Parent-Child Dysfunctional Interaction subscale, range 12-60. Higher scores indicate parents feel their child is not meeting their expectations when interacting. Difficult Child, range is 12-60. Higher scores indicate that parents view their child to be difficult to parent.|Week 9|Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.|||units on a scale||Standard Deviation|Mean
2607476|NCT02088905|Secondary|Dyadic Parent-Child Interaction Coding System Scores|"The Dyadic Parent-Child Interaction Coding System (DPICS) codes frequency of behaviors that occur during five minutes of child lead play, then parent lead play, and then clean-up.~Positive Skills score was the total frequency of behavioral descriptions, reflections, and labeled praise throughout the three conditions.~Negative skills score was a combination of the total frequency of questions, negative talk, and indirect commands throughout all conditions, as well as direct commands during child lead play. It was expected that parents would give commands during parent-lead play or clean-up."|Week 18|Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.|||counts of behaviors||Standard Deviation|Mean
2607477|NCT02088905|Secondary|Dyadic Parent-Child Interaction Coding System Scores|"The Dyadic Parent-Child Interaction Coding System (DPICS) codes frequency of behaviors that occur during five minutes of child-lead play, then parent-lead play, and then clean-up.~Positive Skills score is the total frequency of behavioral descriptions, reflections, and labeled praise throughout the three conditions.~Negative skills score is a combination of the total frequency of questions, negative talk, and indirect commands throughout all conditions, as well as direct commands during child lead play. It was expected that parents would give commands during parent-lead play or clean-up."|Week 9|Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.|||frequency of behaviors||Standard Deviation|Mean
2607492|NCT02088216|Secondary|Change of Forced Expiratory Volume in One Second (FEV1) (L) From Baselines|The change was calculated from two time points as the value at the later time point minus the value at the earlier time point.|12 months||||L||Standard Deviation|Mean
2607493|NCT02088216|Secondary|Change in Percentage of Predicted Forced Expiratory Volume in One Second (FEV1%) From Baselines|The change was calculated from two time points as the value at the later time point minus the value at the earlier time point.|12 months||||percentage of predicted FEV1||Standard Deviation|Mean
2607478|NCT02088905|Secondary|Social Responsiveness Scale 2 Score|Social Responsiveness Scale 2nd edition (SRS-2). SRS-2 Total Score is sum of subscales, higher scores mean more impairment. Range 0-195. Social Awareness measures social awareness impairment, higher scores mean more impairment. Range 0-24. Social Cognition measures social cognition impairment, higher scores mean more impairment. Range 0-36. Social Communication measures social communication impairment, higher scores mean more impairment. Range 0-66. Social Motivation measures social motivation impairment, higher scores means more impairment. Range 0 - 33. Restricted and Repetitive Behaviors measures restricted and repetitive behaviors, with higher scores indicating more impairment. Range 0 - 36.|Week 18|Data missing from some participants. Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.|||units on a scale||Standard Deviation|Mean
2607479|NCT02088905|Secondary|Social Responsiveness Scale 2 Score|Social Responsiveness Scale 2nd edition (SRS-2). SRS-2 Total Score is sum of subscales, higher scores mean more impairment. Range 0-195. Social Awareness measures social awareness impairment, higher scores mean more impairment. Range 0-24. Social Cognition measures social cognition impairment, higher scores mean more impairment. Range 0-36. Social Communication measures social communication impairment, higher scores mean more impairment. Range 0-66. Social Motivation measures social motivation impairment, higher scores means more impairment. Range 0 - 33. Restricted and Repetitive Behaviors measures restricted and repetitive behaviors, with higher scores indicating more impairment. Range 0 - 36.|Week 9|Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.|||units on a scale||Standard Deviation|Mean
2607480|NCT02088905|Secondary|Parental Stress Index-4 Short Form|"Parental Stress Index-4 Short Form (PSI) is comprised of several subscales that are independently measured and also combined to create a total score. Scores are calculated from 36 questions that rated as Strongly Agree/Agree/Not Sure/Disagree/Strongly Disagree by the parents. Ratings are attached to a 5-point Likert scale.~PSI Defensive Responding subscale range: 7-35. Lower scores indicate higher defensive responding from parents.~For the PSI Parental Distress subscale, range 12-60. Higher scores indicate higher parental stress in the parenting.~For the PSI Parent-Child Dysfunctional Interaction subscale, range 12-60. Higher scores indicate parents feel their child is not meeting their expectations when interacting.~For the PSI Difficult Child subscale, range 12-60. Higher scores indicates parents view their child to be difficult to parent.~For PSI Total Stress, range 43-215. Higher scores indicate higher stress."|Week 18|Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.|||units on a scale||Standard Deviation|Mean
2607481|NCT02088905|Primary|Eyberg Child Behavior Inventory|"Eyberg Child Behavior Inventory (ECBI). For families receiving PCIT training, the ECBI will be completed at screen, at each PCIT training visit and at the 12-week post-treatment visit. Wait-list control families will complete the ECBI at screen as well as at weeks 9 and 18. Reported week 18~The ECBI contains the Intensity Score calculated from 36 items rated on frequency of behavior from 1 (Never) to 7 (Always).~Intensity score range is 36-252, with higher scores indicating a higher frequency of problem behaviors.~The ECBI contains the Problem Score calculated from 36 items rated on whether the particular behavior is considered by the to be a problem (yes) or not (no).~Problem score range is 0-36, with higher scores indicating a higher frequency of problem behaviors."|Week 18|Following the intent-to-treat principle, last observation carried forward for 2 subjects in treatment group who dropped out after Week 9. Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.|||units on a scale||Standard Deviation|Mean
2607482|NCT02088905|Primary|Eyberg Child Behavior Inventory|"Eyberg Child Behavior Inventory (ECBI). For families receiving PCIT training, the ECBI will be completed at screen, at each PCIT training visit and at the 12-week post-treatment visit. Wait-list control families will complete the ECBI at screen as well as at weeks 9 and 18. Reported week 9.~The ECBI contains the Intensity Score calculated from 36 items rated on frequency of behavior from 1 (Never) to 7 (Always).~Intensity score range is 36-252, with higher scores indicating a higher frequency of problem behaviors.~The ECBI contains the Problem Score calculated from 36 items rated on whether the particular behavior is considered by the to be a problem (yes) or not (no).~Problem score range is 0-36, with higher scores indicating a higher frequency of problem behaviors."|Week 9|Subjects who dropped out prior to Week 9 (2 in treatment group, 1 in wait list control) were not included in analysis.|||units on a scale||Standard Deviation|Mean
2607483|NCT02088788|Secondary|Radiation Exposure to Operator During Diagnostic Catheterization With Versus Without Ventriculography/Aortography|mSieverts radiation dose to the operator during diagnostic catheterization with versus without ventriculography/aortography. This outcome measure includes 2 types of procedures: diagnostic catheterization plus LV gram and diagnostic catheterization plus aortography. Ventriculography is defined as injection through a pigtail catheter into the left ventricle using a power injector. Aortography is defined as injection through a pigtail catheter into the aorta using a power injector.|During procedure, an average of 35 minutes||||mSv||Inter-Quartile Range|Median
2607484|NCT02088788|Primary|Operator Radiation Exposure|mSieverts radiation dose to the operator during diagnostic catheterization|during initial diagnostic catheterization procedure, an average of 30 minutes||||mSv||Inter-Quartile Range|Median
2607485|NCT02088385|Secondary|Initial Hemostasis Rate|Endoscopically verified cessation of bleeding for at least 5 minutes after treatment.|Within first endoscopy session||||Participants|||Count of Participants
2607486|NCT02088385|Primary|Re-bleeding Within 4 Weeks|"drop in hemoglobin of at least 2 g/dl, associated with overt signs of GI bleed (melena, and/or hematemesis)~fresh blood hematemesis~melena with a hemodynamic instability (pulse rate > 100/min, systolic blood pressure < 90 mm Hg)"|4 weeks||||Participants|||Count of Participants
2607487|NCT02088216|Secondary|Adverse Events (AEs) (Elevation of Liver Enzymes)||12 months||||Participants|||Count of Participants
2607488|NCT02088216|Secondary|Nature of Sputum (Number of Patients With Yellow Purulent)||12 months||||Participants|||Count of Participants
2607489|NCT02088216|Secondary|Time to Recurrent Exacerbations||12 months||||days||95% Confidence Interval|Mean
2607490|NCT02088216|Secondary|Time to the First Exacerbation||12 months||||days||95% Confidence Interval|Median
2607494|NCT02088216|Secondary|Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores From Baselines|"Chronic Obstructive Pulmonary Disease Assessment Test (CAT) scores: the minimum value is 0 and the maximum value is 40.~0-10 points: slight impact; 11-20 points: medium impact; 21-30 points: serious impact; 31-40 points: very serious impact.~The change was calculated from two time points as the value at the later time point minus the value at the earlier time point."|12 months||||score on a scale||Standard Deviation|Mean
2607495|NCT02088216|Secondary|Change of Number of Patients With a Positive Sputum Culture for Pseudomonas Aeruginosa|The values in the table were calculated as the value at baseline minus the value at 12 months.|12 months||||Participants|||Count of Participants
2607496|NCT02088216|Secondary|Change of Volume of Sputum From Baseline Parameters After the 12-month Follow-up.|The change was calculated from two time points as the value at the later time point minus the value at the earlier time point.|12 months||||mL||Standard Deviation|Mean
2607497|NCT02088216|Primary|Median Number of Exacerbations|An exacerbation of bronchiectasis is defined as either a change in one or more of the common symptoms of bronchiectasis (sputum volume or purulence, dyspnea, cough, and fatigue/malaise) or the onset of new symptoms (fever, pleurisy, haemoptysis or need for antibiotic treatment).|12 months||||exacerbations||Inter-Quartile Range|Median
2607498|NCT02088177|Primary|Number of Participants Receiving the Second Injection of Study Medication|The number of participants who accept the second injection at week 5 will be used as one measure of tolerability.|Weeks 1 - 5||||Participants|||Count of Participants
2607499|NCT02088177|Primary|Change in Marijuana Use|Change in marijuana use, as measured by comparing the mean number of self reported days of marijuana use per week in the final study week, which will be week 8 or earlier if the participant discontinues as compared to the mean number of self reported days of marijuana use in week 1|Weeks 1 - 8||||days||Standard Deviation|Mean
2607500|NCT02088073|Secondary|Median Time to Normalization (3.50-5.0 mmol/L) in S-K Levels in the 48 Hours of Initial Treatment||Through 48 hours acute phase|Acute Phase ITT Population included all subjects who received at least 1 Acute Phase dose and had any post-baseline S-K levels after receiving the investigational product during the first 48 hours.|||Hours||95% Confidence Interval|Median
2607501|NCT02088073|Secondary|Proportion of Subjects Who Achieve Normokalemia During the Acute Phase at 24 and 48 Hours After Start of Dosing||Through 48 hours acute phase|Acute Phase ITT Population included all subjects who received at least 1 Acute Phase dose and had any post-baseline S-K levels after receiving the investigational product during the first 48 hours.|||Proportion of subjects|||Number
2607502|NCT02088073|Secondary|Mean Percent Change From Baseline in S-K Values (Blood) at All Measured Time Intervals Post Dose Acute Phase.||All measured time intervals post dose during the Acute Phase.|Acute Phase ITT Population included all subjects who received at least 1 Acute Phase dose and had any post-baseline S-K levels after receiving the investigational product during the first 48 hours.|||Percent Change||Standard Deviation|Mean
2607503|NCT02088073|Secondary|Mean Change From Baseline in S-K Values (Blood) at All Measured Time Intervals Post Dose Acute Phase.||All measured time intervals post dose during the Acute Phase.|Acute Phase ITT Population included all subjects who received at least 1 Acute Phase dose and had any post-baseline S-K levels after receiving the investigational product during the first 48 hours.|||mmol/L||Standard Deviation|Mean
2607504|NCT02088073|Secondary|Exponential Rate of Change in S-K Values During the Acute Phase at 24 Hours and 48 Hours of Study Drug Treatment.||Acute Phase 24 hours and Acute Phase 48 hours.|Acute Phase ITT Population included all subjects who received at least 1 Acute Phase dose and had any post-baseline S-K levels after receiving the investigational product during the first 48 hours.|||log(mmol/L/hour)||Standard Error|Mean
2607505|NCT02088073|Secondary|Median Time to Relapse in S-K Values|Median time to relapse in S-K values (return to original Acute Phase S-K baseline value)|Maintenance phase Study Day 1 to Study Day 29/Exit.|Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8.|||Days||95% Confidence Interval|Median
2607506|NCT02088073|Secondary|Proportion of Subjects Who Remained Normokalemic During Maintenance Phase||Maintenance Phase Study Days 1, 2, 5, 8, 12, 15, 19, 22, 26, 29, and 35, inclusive.|Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8.|||Proportion of subjects|||Number
2607507|NCT02088073|Secondary|Mean S-K Intra-subject Standard Deviation Calculated Among Subjects With ≥ 2 Values on or After Maintenance Phase Study Day 8||22 days; Maintenance Phase Day 8 - 29|Maintenance Phase Intent- to-Treat (ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Day 8.|||mmol/L||95% Confidence Interval|Mean
2607508|NCT02088073|Secondary|Median Time to Hyperkalemia (S-K ≥ 5.1mmol/L)||Maintenance Phase baseline to maintenance Phase Study Day 29/Exit.|Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8.|||Days||95% Confidence Interval|Median
2607509|NCT02088073|Secondary|Mean Percent Change in S-K Levels From Maintenance Phase Baseline to Maintenance Phase Day 2 to Day 29/Exit.||Maintenance phase baseline to Maintenance Phase Study Day 29/Exit, inclusive.|Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8.|||Percent Change||Standard Deviation|Mean
2607510|NCT02088073|Secondary|Mean Change in S-K Levels From Maintenance Phase Baseline to Maintenance Phase Day 2 to Day 29/Exit.||Maintenance phase baseline to Maintenance Phase Study Day 29/Exit, inclusive.|Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8.|||mmol/L||Standard Deviation|Mean
2607511|NCT02088073|Secondary|Mean Percent Change in S-K Levels From Acute Phase Baseline to Maintenance Phase Study Day 2 to Day 29/Exit, Inclusive .||Acute Phase baseline to Maintenance Phase Study Day 2 to Day 29/Exit, inclusive.|Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8.|||Percent Change||Standard Deviation|Mean
2607512|NCT02088073|Secondary|Mean Change in S-K Levels From Acute Phase Baseline to Maintenance Phase Study Day 2 to Day 29/Exit .||Acute Phase baseline to Maintenance Phase Study Day 2 to Day 29/Exit, inclusive.|Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized subjects who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8.|||mmol/L||Standard Deviation|Mean
2607513|NCT02088073|Secondary|The Number of Normokalemic Days Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT).|The number of normokalemic days during the Maintenance Phase Study Days 8 to 29 is calculated assuming that the interval between assessments is normokalemic only if both the beginning and end assessments for that time interval display normal S-K values (i.e. 3.5 - 5.0 mmol/L)|22 days; Maintenance Phase Day 8 - 29, inclusive.|Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized patients who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8.|||Days||Standard Deviation|Mean
2607514|NCT02088073|Primary|Mean Serum Potassium Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT Population).|The least squares means (LSMeans) are dervied from a mixed effects model of serial log transformed S-K values between Days 8 and 29 with patients as a random effect and the following fixed effects terms: MP treatment group; AP baseline eGFR; AP and MP baseline S-K levels, age categories (<55, 55-64, >= 65 years); and binary indicators for RAAS inhibitors use, CKD, CHF, and DM. The LSmeans estimate obtained from the above model is back-transformed and presented as the lsmeans of all available S-K values during the Maintenance phase study Days 8 to 29.|22 Days; Maintenance Phase Days 8 - 29, inclusive.|Maintenance Phase Intent- to-Treat (MP-ITT) population: all randomized patients who received at least 1 Maintenance Phase dose and had at least 1 observed S-K assessment on or after Study Day 8.|||mmol/L||95% Confidence Interval|Least Squares Mean
2607515|NCT02087995|Primary|The Percentage of Agreement of the Continuous Glucose Monitoring System Glucose Values Comparing to a Laboratory Reference, Yellow Sprint Instrument (YSI) Measurement.|The percentage of CGM system values that are within 20% of the reference value for YSI glucose levels > 80 mg/dL or within 20 mg/dL at the reference glucose levels < 80 mg/dL.|7-day wear period|For the demographic and other baseline characteristic information, data from all 51 enrolled subjects was summarized.|||Units analyzed% matched pairs w/i %20/20|||Number
2607516|NCT02087956|Secondary|Domestic Violence (Feldhaus)|Feldhaus Partner Violence Screen is 3 items measure assessing physical abuse by partner in the past year. Scale range: 0-3; higher the score higher frequency of physical abuse.|baseline, post treatment (4 months after enrollment), 3 and 6 months follow-up (7 and 10 months after enrollment)|We had attrition of 5% throughout the study; additionally we had some missing data.|||units on a scale||Standard Deviation|Mean
2607517|NCT02087956|Primary|Client Satisfaction Questionnaire- 8 Items|"The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report instrument to assess subjective satisfaction with treatment which was administered to all participants post-treatment We analyzed 4 items: CSQ1: How would you rate the quality of service you have received?, CSQ 3: To what extent has our program met your needs?, CSQ 6: Have the services you received helped you to deal more effectively with your problems? and CSQ 7: In an overall, general sense, how satisfied are you with the service you have received? (1 = Excellent, 2 = Good, 3 = Fair, 4 = Poor). We are reporting on CSQ 1 outcome."|Post treatment- 4 months after enrollment, 3 and 6 months follow-up (7 and 10 months after the enrollment)|We had attrition of about 5% throughout the study, therefor number of analyzed at post treatment differs from initial number of participants|||units on a scale||Standard Deviation|Mean
2607518|NCT02087956|Primary|Depression Change Outcome Measure|Depression was measured by PHQ-9, a screen for major depressive disorder with good discriminant validity and sensitivity to change validated in Ob/Gyn settings, and with pregnant and postpartum women, and with women of color. Scale ranges 0-27. Higher the score, higher severity of depression and cutpoints of 5, 10, 15 and 20 representing mild, moderate, moderately severe and severe levels of depressive symptoms.|baseline, post treatment (4 months after enrollment), 3 months and 6 months follow up (7 and 10 months after enrollment)|We had 5% attrition throughout the study, therefore number of subjects differ at each assessment point.|||units on a scale||Standard Deviation|Mean
2607519|NCT02087956|Primary|Patient Quality of Life|"We will use the WHOQOL-BREF measure. The WHOQOL-bref contains 26 items; the first two questions evaluate self-perceived quality of life and satisfaction with health.The remaining 24 questions represent four domains: physical, psychological, social relationships and environment.~The WHOQOL-bref contains five Likert style response scales: very poor to very good (evaluation scale), very dissatisfied to very satisfied (evaluation scale), none to extremely (intensity scale), none to complete (capacity scale) and never to always (frequency scale).The mean score in each domain indicates the individual's perception of their satisfaction with each aspect of their life, relating it with quality of life. The higher the score, the better this is perceived to be. Total score was computed by summing all 26 items. The possible range is from 26 to 130."|Post treatment (4 months after enrollment)|Results are presented for WHO-QOL total score. We had attrition of about 5% throughout the study, therefore number of analyzed at post treatment differs from initial number of participants.|||units on a scale||Standard Deviation|Mean
2607520|NCT02087943|Secondary|Number of Participants With TEAEs During the Apremilast Exposure Period|A TEAE is an adverse event with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.|Baseline to Week 24; median duration of apremilast 30 mg was 23.3 weeks and 22.4 weeks for apremilast 40 mg|Safety population includes all participants who received at least one dose of IP. These were Apremilast participants as treated.|||participants|||Number
2607620|NCT02085785|Secondary|Change in Weight|Changes between baseline and 20-weeks later (end of intervention)|Baseline and follow-up assessment (20-weeks after randomization)|Those who were not assessed at 20 weeks were assumed to have the same values as at baseline (last observation carried forward)|||pounds||95% Confidence Interval|Mean
2607521|NCT02087943|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period|A TEAE is an adverse event with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event.|Baseline to Week 12|Safety population includes all participants who received at least one dose of IP.|||participants|||Number
2607522|NCT02087943|Secondary|The Percentage Change From Baseline in the Average Weekly Pruritus Numerical Rating Scale (NRS) Score at Week 4|"The participant completed a daily diary recording the average intensity of pruritus they experienced during the preceding 24 hrs. The intensity of pruritus was assessed using a validated 11-point NRS, ranging from 0 (no pruritus) to 10 (the worst pruritus imaginable). It should be noted that this NRS is distinct from the pruritus, Visual Analogue Scale (VAS) in the Modified SCORAD Index with respect to recall period (three days for the VAS). The weekly NRS score was calculated as the average of the NRS scores over 7 days within the specified week. A higher score indicated worse disease status, and a negative change from baseline indicated improvement."|Baseline to Week 4|All participants who were randomized as specified in the protocol and who received at least one dose of IP with a baseline and at least 1 postbaseline value at or before Week 4 were included. LOCF.|||percent change||Standard Error|Least Squares Mean
2607523|NCT02087943|Secondary|Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI 50) at Week 12|The EASI 50 reduction (defined as ≥ 50% reduction from baseline in EASI score) was selected to serve as the key responder endpoint. A ≥ 50% improvement is clinically meaningful for this population.|Baseline to Week 12|ITT includes all participants who were randomized as specified in the protocol and received at least one dose of IP. LOCF.|||percentage of participants|||Number
2607524|NCT02087943|Secondary|Percentage of Participants Who Achieved a Score of 0 (Cleared) or 1 (Almost Cleared) and at Least a 2-point Reduction From Baseline in a Static Physician's Global Assessment of Acute Signs (sPGA-A) at Week 12.|"The sPGA-A is intended to assess the global severities (ie, a visual average integrating all areas of AD) of key acute clinical signs of AD, including erythema, induration/papulation, oozing/crusting (lichenification excluded) based on a 5-point scale of cleared (0), almost cleared (1), mild (2), moderate (3) and severe (4)."|Baseline to Week 12|ITT includes all participants who were randomized as specified per protocol and received at least one dose of IP. LOCF for missing data handling.|||percentage of participants|||Number
2607525|NCT02087943|Primary|Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12.|EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). A representative lesion is selected for each of the four body regions for assessing the intensity of each of the four signs (erythema, induration /papulation, excoriation, and lichenification). Symptoms (eg, pruritus) and secondary signs (eg, xerosis, scaling) are excluded from the assessment. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.|Baseline to Week 12|All participants who were randomized as specified per protocol and who received at least one dose of IP with a baseline and at least 1 post baseline value at or before week 12; A missing value at Week 12 was imputed by last observation carried forward (LOCF), including the value obtained at the Early Termination Visit prior to Week 12.|||percent change||Standard Error|Least Squares Mean
2607526|NCT02087904|Secondary|Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 52|Percentage of participants classified as OMERACT-OARSI responders at Week 52. A subject was considered an OMERACT-OARSI responder if any of the following 3 criteria were met: 1. WOMAC Pain (in 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 2. WOMAC Function (in normalized 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 3. At least 2 of the following 3 are met: WOMAC Pain improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; WOMAC Function improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; PGA improvement ≥ 20% and absolute change (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline. Response rate 95% confidence interval based on normal approximation.|Week 52|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, LOCF.|||percentage of participants||95% Confidence Interval|Number
2607527|NCT02087904|Secondary|Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 26|Percentage of participants classified as OMERACT-OARSI responders at Week 26. A subject was considered an OMERACT-OARSI responder if any of the following 3 criteria were met: 1. WOMAC Pain (in 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 2. WOMAC Function (in normalized 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 3. At least 2 of the following 3 are met: WOMAC Pain improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; WOMAC Function improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; PGA improvement ≥ 20% and absolute change (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline. Response rate 95% confidence interval based on normal approximation.|Week 26|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, LOCF.|||percentage of participants||95% Confidence Interval|Number
2607561|NCT02087423|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first dose until death due to any cause (ie, date of death or censoring - date of first dose + 1). Results are reported as median OS, calculated using the Kaplan-Meier methodology.|From date of first treatment until final DCO (up to approximately 3 years 8 months)|The FAS included all treated patients who had a baseline tumor assessment and had measurable disease at baseline according to the Investigator site assessment.|||Months||95% Confidence Interval|Median
2607528|NCT02087904|Secondary|Outcome Measures in Rheumatology Clinical Trials/Osteoarthritis Research Society International (OMERACT/OARSI) Response Rate at Week 16|Percentage of participants classified as OMERACT-OARSI responders at Week 16. A subject was considered an OMERACT-OARSI responder if any of the following 3 criteria were met: 1. WOMAC Pain (in 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 2. WOMAC Function (in normalized 0 - 100 scale) improvement ≥ 50% and absolute reduction ≥ 20 as compared to the baseline; or 3. At least 2 of the following 3 are met: WOMAC Pain improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; WOMAC Function improvement ≥ 20% and absolute reduction (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline; PGA improvement ≥ 20% and absolute change (in normalized 0 - 100 scale) ≥ 10 as compared to the baseline. Response rate 95% confidence interval based on normal approximation.|Week 16|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, LOCF.|||percentage of participants||95% Confidence Interval|Number
2607529|NCT02087904|Secondary|Change From Baseline in Cartilage Thickness of the Index Knee at Week 52|Cartilage thickness of the global knee, the medial central condyle + plateau, and the medial condyle + plateau was measured using MRI.|Baseline, Week 52|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.|||mm||95% Confidence Interval|Least Squares Mean
2607530|NCT02087904|Secondary|Change From Baseline in Cartilage Thickness of the Index Knee at Week 26|Cartilage thickness of the global knee, the medial central condyle + plateau, and the medial condyle + plateau was measured using MRI.|Baseline, Week 26|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.|||mm||95% Confidence Interval|Least Squares Mean
2607531|NCT02087904|Secondary|Change From Baseline in Cartilage Volume of the Index Knee at Week 52|Cartilage volume of the global knee, the medial central condyle + plateau, and the medial condyle + plateau was measured using MRI.|Baseline, Week 52|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.|||mm^3||95% Confidence Interval|Least Squares Mean
2607532|NCT02087904|Secondary|Change From Baseline in Cartilage Volume of the Index Knee at Week 26|Cartilage volume of the global knee, the medial central condyle + plateau, and the medial condyle + plateau was measured using MRI.|Baseline, Week 26|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.|||mm^3||95% Confidence Interval|Least Squares Mean
2607533|NCT02087904|Secondary|Change From Baseline in PGA of Arthritis of the Index Knee at Week 52|The PGA is a single item for evaluating overall osteoarthritis disease activity. PGA is assessed using an 11-point NRS of 0 to 10 points (representing best to worst disease status, respectively), with a 7-day recall period.|Baseline, Week 52|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.|||units on a scale||95% Confidence Interval|Least Squares Mean
2607534|NCT02087904|Secondary|Change From Baseline in PGA of Arthritis of the Index Knee at Week 26|The PGA is a single item for evaluating overall osteoarthritis disease activity. PGA is assessed using an 11-point NRS of 0 to 10 points (representing best to worst disease status, respectively), with a 7-day recall period.|Baseline, Week 26|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.|||units on a scale||95% Confidence Interval|Least Squares Mean
2607535|NCT02087904|Secondary|Change From Baseline in Patient Global Assessment (PGA) of Arthritis of the Index Knee at Week 16|The PGA is a single item for evaluating overall osteoarthritis disease activity. PGA is assessed using an 11-point NRS of 0 to 10 points (representing best to worst disease status, respectively), with a 7-day recall period.|Baseline, Week 16|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.|||units on a scale||95% Confidence Interval|Least Squares Mean
2607536|NCT02087904|Secondary|Change From Baseline In Index Knee Pain Intensity at Week 52|The index knee pain intensity was assessed in 3 different ways using an 11 -point NRS (0 to 10 points representing 'no pain' to 'worst possible pain'). Subjects were asked to enter: 1) average pain intensity during the past week (7-day recall period); 2) the worst pain during activity over the past 24 hours; 3) pain intensity before and after a 40 meter walk (performance pain, before and after). The 40 meter fast paced walk test is a test of short distance walking activity, walking speed over short distances and changing direction during walking. Individuals taking the test should walk as quickly but as safely as possible, without running, along a walkway and then turn around, and repeat again for a total distance of 40 m (132 feet). The total time taken to walk the 40 meters is recorded.|Baseline, Week 52|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.|||units on a scale||95% Confidence Interval|Least Squares Mean
2607537|NCT02087904|Secondary|Change From Baseline In Index Knee Pain Intensity at Week 26|The index knee pain intensity was assessed in 3 different ways using an 11 -point NRS (0 to 10 points representing 'no pain' to 'worst possible pain'). Subjects were asked to enter: 1) average pain intensity during the past week (7-day recall period); 2) the worst pain during activity over the past 24 hours; 3) pain intensity before and after a 40 meter walk (performance pain, before and after). The 40 meter fast paced walk test is a test of short distance walking activity, walking speed over short distances and changing direction during walking. Individuals taking the test should walk as quickly but as safely as possible, without running, along a walkway and then turn around, and repeat again for a total distance of 40 m (132 feet). The total time taken to walk the 40 meters is recorded.|Baseline, Week 26|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.|||units on a scale||95% Confidence Interval|Least Squares Mean
2607538|NCT02087904|Secondary|Change From Baseline In Index Knee Pain Intensity at Week 16|The index knee pain intensity was assessed in 3 different ways using an 11 -point NRS (0 to 10 points representing 'no pain' to 'worst possible pain'). Subjects were asked to enter: 1) average pain intensity during the past week (7-day recall period); 2) the worst pain during activity over the past 24 hours; 3) pain intensity before and after a 40 meter walk (performance pain, before and after). The 40 meter fast paced walk test is a test of short distance walking activity, walking speed over short distances and changing direction during walking. Individuals taking the test should walk as quickly but as safely as possible, without running, along a walkway and then turn around, and repeat again for a total distance of 40 m (132 feet). The total time taken to walk the 40 meters is recorded.|Baseline, Week 16|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.|||units on a scale||95% Confidence Interval|Least Squares Mean
2607539|NCT02087904|Secondary|Change From Baseline in Index Knee ICOAP Scores at Week 52|The ICOAP is a multidimensional osteoarthritis-specific measure designed to comprehensively evaluate the pain experience in patients with hip or knee osteoarthritis. The ICOAP includes 11 items (5 constant pain items; 6 intermittent pain items). Each item is rated on a 0 to 4 point scale with a 7-day recall period. The raw maximum intermittent pain score ranges from 0 to 24, transformed to a reported scale of 0 (no pain) to 100 (worst pain). The raw maximum constant pain score ranges from 0 to 20, transformed to a reported scale of 0 (no pain) to 100 (worst pain).|Baseline, Week 52|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.|||score on a scale||95% Confidence Interval|Least Squares Mean
2607540|NCT02087904|Secondary|Change From Baseline in Index Knee ICOAP Scores at Week 26|The ICOAP is a multidimensional osteoarthritis-specific measure designed to comprehensively evaluate the pain experience in patients with hip or knee osteoarthritis. The ICOAP includes 11 items (5 constant pain items; 6 intermittent pain items). Each item is rated on a 0 to 4 point scale with a 7-day recall period. The raw maximum intermittent pain score ranges from 0 to 24, transformed to a reported scale of 0 (no pain) to 100 (worst pain). The raw maximum constant pain score ranges from 0 to 20, transformed to a reported scale of 0 (no pain) to 100 (worst pain).|Baseline, Week 26|Modified Intent to Treat population: all subjects who received at least 1 dose of study drug, observed cases.|||score on a scale||95% Confidence Interval|Least Squares Mean
2607541|NCT02087904|Secondary|Change From Baseline in Index Knee Intermittent and Constant Osteoarthritis Pain (ICOAP) Scores at Week 16|The ICOAP is a multidimensional osteoarthritis-specific measure designed to comprehensively evaluate the pain experience in patients with hip or knee osteoarthritis. The ICOAP includes 11 items (5 constant pain items; 6 intermittent pain items). Each item is rated on a 0 to 4 point scale with a 7-day recall period. The raw maximum intermittent pain score ranges from 0 to 24, transformed to a reported scale of 0 (no pain) to 100 (worst pain). The raw maximum constant pain score ranges from 0 to 20, transformed to a reported scale of 0 (no pain) to 100 (worst pain).|Baseline, Week 16|Modified Intent to Treat population: all subjects who received at least 1 dose of study drug, observed cases.|||score on a scale||95% Confidence Interval|Least Squares Mean
2607542|NCT02087904|Secondary|Change From Baseline in Global Total BML Score of the Index Knee MRI at Week 52|BMLs in 15 regions were measured with MRI, and graded as 0 (normal), 1 (mild; < 25% of region), 2 (moderate; 25% - 50% of region), or 3 (severe; > 50% of region). The global total BML score was the sum of the 15 component scores, and ranged from 0 (normal) to 45 (severe).|Baseline, Week 52|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.|||score on a scale||95% Confidence Interval|Least Squares Mean
2607543|NCT02087904|Secondary|Change From Baseline in Global Total Bone Marrow Lesion (BML) Score of the Index Knee Magnetic Resonance Imaging (MRI) at Week 26|BMLs in 15 regions were measured with MRI, and graded as 0 (normal), 1 (mild; < 25% of region), 2 (moderate; 25% - 50% of region), or 3 (severe; > 50% of region). The global total BML score was the sum of the 15 component scores, and ranged from 0 (normal) to 45 (severe).|Baseline, Week 26|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.|||score on a scale||95% Confidence Interval|Least Squares Mean
2607544|NCT02087904|Secondary|Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 52|The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) numerical rating scale (NRS). The pain sub-score has a range of 0 (no pain) to 50 (maximum pain). A negative change from baseline indicates improvement.|Baseline, Week 52|Modified intent to Treat population: all participants who received at least 1 dose of study drug, LOCF (missing responses were imputed by calculation based on the last non-missing post-baseline component values).|||score on a scale||95% Confidence Interval|Least Squares Mean
2607545|NCT02087904|Secondary|Change From Baseline in WOMAC Pain Scores of the Index Knee at Week 26|The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) numerical rating scale (NRS). The pain sub-score has a range of 0 (no pain) to 50 (maximum pain). A negative change from baseline indicates improvement.|Baseline, Week 26|Modified intent to Treat population: all subjects who received at least 1 dose of study drug, LOCF (missing responses were imputed by calculation based on the last non-missing post-baseline component values).|||score on a scale||95% Confidence Interval|Least Squares Mean
2607546|NCT02087904|Secondary|Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 52|The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) NRS. The WOMAC physical function subscale score was 0 (normal) to 170 (least physical function). A negative change from baseline indicates improvement.|Baseline, Week 52|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, LOCF (missing responses were imputed by calculation based on the last non-missing post-baseline component values).|||score on a scale||95% Confidence Interval|Least Squares Mean
2607547|NCT02087904|Secondary|Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 26|The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) NRS. The WOMAC physical function subscale score was 0 (normal) to 170 (least physical function). A negative change from baseline indicates improvement.|Baseline, Week 26|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, LOCF (missing responses were imputed by calculation based on the last non-missing post-baseline component values).|||score on a scale||95% Confidence Interval|Least Squares Mean
2607604|NCT02086565|Secondary|Hospitalizations|Hospitalizations for asthma in the year before baseline to one year after baseline.|Hospitalizations for asthma in the year before baseline to one year after baseline|rate per year|||hospitalizations per year||95% Confidence Interval|Least Squares Mean
2607548|NCT02087904|Secondary|Change From Baseline in WOMAC Physical Function Scores of the Index Knee at Week 16|The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) NRS. The WOMAC physical function subscale score was 0 (normal) to 170 (least physical function). A negative change from baseline indicates improvement.|Baseline, Week 16|Modified intent to Treat population: all participants who received at least 1 dose of study drug, LOCF (missing responses were imputed by calculation based on the last non-missing post-baseline component values).|||score on a scale||95% Confidence Interval|Least Squares Mean
2607549|NCT02087904|Primary|Change From Baseline in Whole-Organ Magnetic Resonance Imaging Score (WORMS) Semi-Quantitative Synovitis/Effusion Score of the Index Knee at Week 26|Semi-quantitative synovitis/effusion volume WORMS scores were scored as normal (0), < 33% of maximum estimated distention (1), 33% - 66% of maximum estimated distention (2), or > 66% of maximum estimated distention (3).|Baseline, Week 26|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.|||score on a scale||95% Confidence Interval|Least Squares Mean
2607550|NCT02087904|Primary|Change From Baseline in Effusion Volume of the Index Knee at Week 26||Baseline, Week 26|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.|||mL||95% Confidence Interval|Least Squares Mean
2607551|NCT02087904|Primary|Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26|Change in synovitis of the index knee was evaluated using quantitative magnetic resonance imaging (MRI) measurements. MRI quantitative synovitis of the index knee was defined by mean synovial membrane thickness.|Baseline, Week 26|Modified Intent to Treat population: all participants who received at least 1 dose of study drug, observed cases.|||mm||95% Confidence Interval|Least Squares Mean
2607552|NCT02087904|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16|The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) numerical rating scale (NRS). The pain sub-score has a range of 0 (no pain) to 50 (maximum pain). A negative change from baseline indicates improvement.|Baseline, Week 16|Modified Intent to Treat population: all subjects who received at least 1 dose of study drug, Last observation carried forward (LOCF; missing responses were imputed by calculation based on the last non-missing post-baseline component values).|||score on a scale||95% Confidence Interval|Least Squares Mean
2607553|NCT02087774|Primary|Change From Baseline to After Intervention for After-Exercise Heart Rate|"Immediate cool-down, after-exercise heart rate was taken.~Difference in heart rate from baseline measurements is reported"|Baseline to 12 weeks later||||beats per minute||95% Confidence Interval|Mean
2607554|NCT02087774|Primary|Change From Baseline to After Intervention in 75 Foot Laps Completed in 2 Minutes|"Subjects run for 2 minutes around cone separated by 75ft. One lap was one 75 foot length completed.~Difference in laps completed from baseline was taken."|Baseline to 12 weeks later||||Difference in Laps Completed||95% Confidence Interval|Mean
2607555|NCT02087748|Secondary|Mean Reduction in SPID Scores of DOMS While Standing Over 24 Hours|"The secondary outcome is the mean reduction in DOMS scores while standing in the leg receiving Topical Voltaren® gel versus the leg receiving placebo over the first 24 hours post treatment initiation.~Pain intensity was assessed at predefined time points (at Predose, 3, 9, 15, 21, and 24 hours after first drug administration) using an 11-point Numeric Rating Scale (NPRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Pain Intensity Differences at each predefined time point (calculated as post-baseline NPRS values - baseline NPRS values) were analyzed. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -50 (indicative of an increase in pain) to 50 (indicative of a decrease in pain)."|7 days||||units on a scale||Standard Deviation|Mean
2607556|NCT02087748|Secondary|Mean Reduction in SPID Scores of DOMS at Rest Over 24 Hours|"The secondary outcome is the mean reduction in DOMS scores at rest in the leg receiving Topical Voltaren® gel versus the leg receiving placebo over the first 24 hours post treatment initiation.~Pain intensity was assessed at predefined time points (at Predose, 3, 9, 15, 21, and 24 hours after first drug administration) using an 11-point Numeric Rating Scale (NPRS) where a score of zero indicates no pain and a score of 10 indicates pain as bad as you can imagine. Pain Intensity Differences at each predefined time point (calculated as post-baseline NPRS values - baseline NPRS values) were analyzed. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -50 (indicative of an increase in pain) to 50 (indicative of a decrease in pain)."|7 days||||units on a scale||Standard Deviation|Mean
2607557|NCT02087748|Primary|Mean Reduction in SPID Scores of DOMS on Walking Over 24 Hours|"The primary outcome is the analgesic efficacy of Topical Voltaren® gel compared to placebo in the reduction of the pain associated with DOMS. The statistical comparison of interest will be the mean reduction in DOMS scores upon walking in the leg receiving Topical Voltaren® gel vs the leg receiving placebo over the first 24 hours post treatment. Pain intensity was assessed at predefined time points (Predose, 3, 9, 15, 21, and 24 hours after first drug administration) using an 11-point Numeric Rating Scale (NPRS) where a score of zero indicates no pain and 10 indicates pain as bad as you can imagine. Pain Intensity Differences at each predefined time point (calculated as post-baseline NPRS values - baseline NPRS values) were analyzed. The theoretical maximum range of Sum of pain intensity differences (SPID24) is from -50 (indicative of an increase in pain) to 50 (indicative of a decrease in pain)."|7 days||||units on a scale||Standard Deviation|Mean
2607558|NCT02087670|Secondary|Oxygen Consumption||8 weeks||||ml/min||Standard Deviation|Mean
2607559|NCT02087670|Primary|Natriuretic Brain Pro-peptid||8 weeks||||pg/ml||Full Range|Median
2607560|NCT02087514|Primary|Non-transferrin-bound Iron Level (AUC)|Area under the curve of change of Non-transferrin-bound iron from immediately after transfusion to end of observation (i.e., from 0-hr after transfusion to 24-hr after transfusion).|0, 2, 4, 6, 8, 10, 12, 14 and 24 after transfusion|52 out of the 60 enrolled subjects completed the study and were included in data analysis.|||microMole*hr/L||Inter-Quartile Range|Median
2608996|NCT02071290|Primary|Endothelial Injury (Heparan Sulfate)|Change in plasma levels of endothelial injury marker Heparan Sulfate over 24 hours from Admission|0 (Admission), 1, 3, 24 hours||||ng/mL||Inter-Quartile Range|Median
2607562|NCT02087423|Secondary|Duration of Response (DoR)|"DoR (per RECIST 1.1 as assessed by the ICR) was defined as the time from the date of first documented response (which was subsequently confirmed) until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). DoR was only analyzed for Cohort 2. Cohort 2: Median DoR was 12.3 months in the PD-L1 high (TC>=25%) group at DCO (Q3 was NR). Of the 7 evaluable patients, the median DoR was not reached in the PD-L1 low/neg group (TC <25%); therefore the DoR number of participants analyzed field has been entered as 0 and the DoR results field has been left blank."|Time from response to progression, death, or last assessment (up to approximately 2 years 3 months for the primary analysis DCO)|The “FAS – evaluable for response per ICR” set for Cohort 2, included all treated patients in Cohort 2 who had a baseline tumor assessment and had measurable disease at baseline according to the ICR.|||Months||Inter-Quartile Range|Median
2607563|NCT02087423|Secondary|Time to Response (TTR)|TTR (per RECIST 1.1 as assessed by the ICR) is defined as the time from the date of first dose until the date of first documented response (which is subsequently confirmed). TTR was only analyzed for Cohort 2.|Responses recorded during initial 12 month treatment period (up to primary analysis DCO)|The “FAS – evaluable for response per ICR” set for Cohort 2, included all treated patients in Cohort 2 who had a baseline tumor assessment and had measurable disease at baseline according to the ICR.|||Months||Full Range|Median
2607564|NCT02087423|Primary|Objective Response Rate (ORR)|Patients commenced treatment with durvalumab on Day 1 and continued on a Q2W schedule for a maximum of 12 months. Tumor assessments using computed tomography / magnetic resonance imaging were performed every 8 weeks. Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) measurements as given by the Independent Central Review (ICR) were used to derive the primary variable of ORR .|Responses recorded during initial 12 month treatment period (up to primary analysis DCO)|The “Full analysis set [FAS] – evaluable for response per ICR” set, included all treated patients who had a baseline tumor assessment and had measurable disease at baseline according to the ICR.|||% of patients evaluable for response||95% Confidence Interval|Number
2607565|NCT02087241|Secondary|Assess Overall Survival in Each Treatment Arm|Overall survival is defined as the time from the date of randomization until death due to any cause.|Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)|Overall Survival (OS) data were not collected.||||||
2607566|NCT02087241|Secondary|Assess the Duration of Response in Each Treatment Arm|Duration of response is defined as the time from the date of first documented response until the date of documented progression or any cause death.|Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)|Duration of response data were not collected.||||||
2607567|NCT02087241|Secondary|Assess the Disease Control Rate in Each Treatment Arm|the disease control rate is defined as the percentage of FAS subjects with a best overall response of CR, PR or SD).|Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)||||Percentage of Participants||90% Confidence Interval|Number
2607568|NCT02087241|Secondary|Assess the Objective Response Rates in Each Arm|The objective response rate is defined as the number of the subjects with a confirmed best overall response of CR or PR divided by the number of subjects in the Full Analysis Set (FAS) for whom measureable disease is present at baseline|Up to a maximum of 4 treatment cycles (treatment cycles will be repeated every 21 days)||||Percentage of Participants||90% Confidence Interval|Number
2607569|NCT02087241|Primary|Progression Free Survival|Progression free survival is defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the subject withdraws from randomised therapy or receives another anti-cancer therapy prior to progression.|6 months|Progression-Free Survival data were not collected.||||||
2607570|NCT02087176|Primary|Objective Response Rate|Response evaluation is determined by using Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions assessed by medical imaging scan (e.g. CT or MRI). The same method of assessment and the same technique was to be used to characterize each identified and reported lesion at baseline and during subsequent imaging procedures. The objective response rate is defined as the percentage of patients with a confirmed best overall response of Complete Response (CR) or Partial Response (PR). Complete Response is defined as disappearance of all target lesions since baseline. Any pathological lymph nodes selected as target lesions must have a reduction in short axis to < 10 mm. Partial Response is defined as at least a 30% decrease in the sum of the diameters of the Target Lesion, taking as reference the baseline sum of diameters.|Up to 20 months|Thirty-two (32) subjects were enrolled in Part A, but the study was terminated early. Patients on-study at the time the study was terminated have been censored.|||Percentage of Participants||90% Confidence Interval|Number
2607571|NCT02087176|Secondary|Pharmacokinetic Profile of AZD 1775 in Combination With Docetaxel|Venous blood samples taken for determination of AZD1775, metabolites of 1775 on Cycle 1, Day 1 pre-dose and 2 hours post dose, Cycle 2 Day 1 pre-dose and 2 hours post dose, and Cycle 4 pre-dose and 2 hours post dose. However, the study was terminated early by the sponsor; therefore, pharmacokinetic data were not collected.|Up to projected 20 months, subjects will be restaged after every 2 cycles (every 6 weeks.) continue until disease progression or unacceptable toxicity|The study was terminated early by the sponsor. Pharmacokinetic data have not been analyzed.||||||
2607572|NCT02087163|Secondary|Length of Treatment Change|Participants will be followed for the duration of orthodontic treatment, an expected average of 78 weeks. Length of treatment change will be measured as the number of weeks of movement per aligner.|Baseline and end of treatment, an average of 78 weeks|all completed subjects|||days||95% Confidence Interval|Mean
2607573|NCT02087163|Primary|Tooth Movement Change|Participants will be followed for the duration of orthodontic treatment, an expected average of 78 weeks. Tooth movement change will be measured as the number of millimeters of tooth movement per aligner.|Baseline and end of treatment, an average of 78 weeks|all completed subjects|||millimeters||95% Confidence Interval|Mean
2607605|NCT02086565|Secondary|Emergency Department Visits|Emergency department visits for asthma from one year before baseline to one year after baseline.|one year before baseline to one year after baseline|ED visits per year over period of participation|||ED visits per year||95% Confidence Interval|Least Squares Mean
2609035|NCT02071095|Secondary|Plasma Interferon-gamma-inducible Protein-10 (IP-10) Level|One of the biomarkers of cellular immune activation and exhaustion quantified by flow cytometry. Normal range is 7.8-500 pg/ml.|Day 2 and Day 4||||pg/ml||Standard Deviation|Mean
2607574|NCT02087150|Other Pre-specified|Exploratory Endpoint: WPAI at 6,12,24,52 Weeks|Evaluation of subjects' work and activity impairment before and after treatment in both the investigational arm and the control arm. The Work Productivity and Activity Impairment (WPAI) questionnaire is a 6-question patient-reported general health assessment of productivity and activity impairment. WPAI results are expressed as the percentage of impairment from 0 to 100 where higher numbers indicate greater impairment or less productivity. Due to an error in the WPAI electronic data collection form, 2 questions were not visible to many subjects resulting in a significant amount of missing data for all scores except non-work activity impairment. Therefore, only the non-work activity impairment results are presented. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.|6,12,24,52 Week Follow-Up|Per-Protocol Cohort: All randomized subjects expect those who: • Did not complete a baseline or respective follow-up assessment for the time point under analysis • Did not receive the treatment for which they were randomized • Had any major protocol deviation(s)|||Percentage of Impairment||Standard Deviation|Mean
2607575|NCT02087150|Other Pre-specified|Exploratory Endpoint: Number of Randomized Subjects With ETDQ-7 Improvement at 12, 24, 52 Weeks|Evaluation of subjects achieving at least a MID level improvement of 0.5 points at 12 weeks, 24 weeks, and 52 weeks post-treatment in the investigational arm and evaluation of subjects achieving at least a MID level improvement at 12 weeks, 24 weeks, and 52 weeks post-randomization in the control arm. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.|12,24,52 Week Follow-Up Visit|Per-Protocol Cohort: All randomized subjects expect those who: • Did not complete a baseline or respective follow-up assessment for the time point under analysis • Did not receive the treatment for which they were randomized • Had any major protocol deviation(s)|||Participants|||Count of Participants
2607576|NCT02087150|Other Pre-specified|Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks|Evaluation of subjects experiencing normalization of tympanometry at 12 weeks, 24 weeks, and 52 weeks post-treatment in the investigational arm and evaluation of subjects experiencing normalization of tympanometry at 12 weeks, 24 weeks, and 52 weeks post-randomization in the control arm. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.|12, 24, 52 Week Follow-Up|Per-Protocol Cohort: All randomized subjects expect those who: • Did not complete a baseline or respective follow-up assessment for the time point under analysis • Did not receive the treatment for which they were randomized • Had any major protocol deviation(s)|||Participants|||Count of Participants
2607577|NCT02087150|Secondary|Secondary Efficacy Endpoint: Number of Randomized Subjects With MID Improvement From Baseline of 0.5 Points or More at 6 Weeks|The secondary efficacy endpoint will consist of comparison of subjects achieving at least a minimally important difference (MID) level improvement of 0.5 points on the ETDQ-7 at 6 weeks post-treatment in the investigational arm versus the proportion of subjects achieving at least an MID level improvement on the ETDQ-7 at 6 weeks post-randomization in the control arm The ETDQ-7 is a seven-item ETD specific validated quality of life survey. A mean item score of greater or equal to 2.1 indicates the presence of ETD.|6 Week Follow-Up Visit|Primary Analysis Cohort (PAC): The PAC is defined as all randomized subjects who receive a study treatment for which they are randomized and have completed their primary analysis visits (i.e. completer analysis with baseline and 6 week tympanogram).|||Participants|||Count of Participants
2607578|NCT02087150|Primary|Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks|The primary efficacy analysis compares randomized subjects with tympanogram normalization (Types B or C normalized to Type A) in all indicated ears at 6 weeks in the investigational arm versus the control arm. Per protocol, tympanogram types are defined as follows: Type A: Peak compliance occurs between +50 and -100 daPa, with minimum peak height of 0.2ml. Indicates NORMAL middle ear function Type B: No sharp peak and a rounded line. Indicates ABNORMAL middle ear function Type C: Peak compliance occurs beyond -100 daPa. Indicates ABNORMAL middle ear function|6 Week Follow-Up Visit|Primary Analysis Cohort (PAC): The PAC is defined as all randomized subjects who receive a study treatment for which they are randomized and have completed their primary analysis visits (i.e. completer analysis with baseline and 6 week tympanogram).|||Participants|||Count of Participants
2607579|NCT02087085|Other Pre-specified|Change From Baseline in Retinal Sensitivity in the Study Eye||Baseline (Day 1) to Month 24|||||||
2607580|NCT02087085|Secondary|Change From Baseline in Low Luminance BCVA Score as Assessed by ETDRS Chart at Month 24|Low Luminance BCVA was measured by placing a 2.0 log unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard BCVA. If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. MMRM was used for analysis.|Baseline (Day 1) to Month 24|Participants from the mITT population, all randomized and treated participants with baseline and at least 1 postbaseline assessment for GA lesion area by FAF, with data available for analysis for this outcome measure at Month 24.|||letters read correctly||Standard Error|Least Squares Mean
2607581|NCT02087085|Secondary|Change From Baseline in Standard Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Month 24|BCVA was measured using an eye chart (ETDRS) and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard BCVA. If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. MMRM was used for analysis.|Baseline (Day 1) to Month 24|Participants from the mITT population, all randomized and treated participants with baseline and at least 1 postbaseline assessment for GA lesion area by FAF, with data available for analysis for this outcome measure at Month 24.|||letters read correctly||Standard Error|Least Squares Mean
2607582|NCT02087085|Primary|Change From Baseline in Geographic Atrophy (GA) Lesion Area of the Study Eye as Assessed by Fundus Autofluorescence (FAF) at Month 24|GA lesion area was measured in mm^2 by FAF in the study eye and was quantified by the central reading center. The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard Best Correct Visual Acuity (BCVA). If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression). Mixed model for repeated measures (MMRM) was used for analysis.|Baseline (Day 1) to Month 24|Participants from the mITT population, all randomized and treated participants with baseline and at least 1 postbaseline assessment for GA lesion area by FAF, with data available for analysis at Month 24.|||mm^2||Standard Error|Least Squares Mean
2607583|NCT02087059|Secondary|Summary of Summary of EORTC QLQ-C30 Responses by Time|The QLQ-C30 version 1.0 (QLQ-C30) incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhea) and perceived financial impact of the disease.All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.|24 weeks|FAS|||units on a scale||Standard Deviation|Mean
2607584|NCT02087059|Secondary|Summary of Total Symptom Score as Measured by Seven-day Modified Myelofibrosis Symptom Assessment Form (MFSAF) v2.0 by Time|The modified MFSAF v2.0 diary captures a patient's symptom severity on a scale of 0 (absent) to 10 (worst imaginable),with a maximal summary score of 60|24 weeks||||score on a scale||Standard Deviation|Mean
2607585|NCT02087059|Secondary|Charge in Spleen Size From Baseline up to the Specified Week|Number of patients with spleen length reduced by ≥ 50% up to specified week|Baseline, 24 weeks||||particiapants|||Number
2607586|NCT02087059|Secondary|Charge in Spleen Size From Baseline at Specified Week|Number of patients with spleen length reduced by ≥ 50% at specified week|Baseline, 24 weeks||||particiapants|||Number
2607587|NCT02087059|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||24 weeks||||Participants|||Number
2607588|NCT02086786|Other Pre-specified|Positive and Negative Syndrome Scale (PANSS) Total Score|"The change in PANSS score from Baseline by visit 48.~The PANSS combines 3 subscales: The positive scale (7 items), the negative scale (7 items) and the general psychopathology scale (16 items).~PANSS Items Scores: 1 = Absent, 2 = Minimal, 3 = Mild, 4 = Moderate, 5 = Moderate Severe, 6 = Severe, 7 = Extreme.~Subscales are summed to compute a total score Range for each of the subscales: Positive scale (7-49); Negative scale (7-49); General psychopathology scale (16-112) Range for the PANSS total scale: 30-210 PANSS total score ≤70: stable schizophrenia PANSS total score between >70: decompensated schizophrenia"|Baseline, Days 5, 7, 10, 14, 18, and 21 post Dose 1; Dose 2, 3 and 4 post dose; Days 5, 7, 10, 14, 18, and 21 post Dose 2, 3, and 4; Days 25, 28, 32, 37, 42, 60, 75, 90, and 105 post Dose 4; Day 120 post Dose 4 or early termination.|The analysis was conduct in the Intent-to-Treat (ITT) Population, which includes all patients in Safety Population with baseline (Day -1) efficacy data and at least 1 post-baseline efficacy evaluation. ITT Population includes 66 patients; 33 on each arm.|||points||Standard Deviation|Mean
2607589|NCT02086786|Secondary|Accumulation Ratio (RA) for Active Moiety|Defined as AUC (0-28 days) after the 4th dose divided by the AUC (0-28 days) of the first dose.|Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population (patients who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis). As determined by the pharmacokineticist, for this analysis, 18 patients in the gluteal and 22 in the deltoid group had concentration amenable to evaluation.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2607590|NCT02086786|Primary|PTF for Active Moiety|Peak to Trough Fluctuation ratio for the Active Moiety|Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conduct in the PK population, which includes 43 patients (20 in the gluteal and 23 in the deltoid site injection group) who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis. They also had concentration data amenable to evaluation as determined by the pharmacokineticist.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2607591|NCT02086786|Primary|Terminal Half-life (t1/2) for Active Moiety||Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population (patients who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis). As determined by the pharmacokineticist, for this analysis, 12 patients in the gluteal and 19 in the deltoid group had concentration amenable to evaluation.|||h||Geometric Coefficient of Variation|Geometric Mean
2607592|NCT02086786|Primary|Time to Peak Concentration (Tmax) for Active Moiety||Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population, which includes 43 patients (20 in the gluteal and 23 in the deltoid site injection group) who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis. They also had concentration data amenable to evaluation as determined by the pharmacokineticist.|||h||Full Range|Median
2607606|NCT02086565|Secondary|Asthma-related Quality of Life|Quality of life is a 15-item questionnaire with 7 point response scale (1-7), higher score is better quality of life. We measured the change from baseline and over a year.|baseline and over a year|Quality of life is a 15-item questionnaire with 7 point response scale (1-7), higher score is better quality of life. Here we measure change in quality of life over time in the study.|||score on a scale||95% Confidence Interval|Least Squares Mean
2607593|NCT02086786|Primary|AUCτ for Active Moiety|AUCτ is the area under the curve over the dosing interval (τ), where the dosing interval is 28 days|Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population: 43 patients (20 in the gluteal and 23 in the deltoid site injection group). As determined by the pharmacokineticist, for Dose 4th analysis, 18 patients in the gluteal and 22 in the deltoid group had concentration amenable to evaluation.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2607594|NCT02086786|Primary|Area Under the Curve Extrapolated to Infinity (AUC∞) for Active Moiety||Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population (patients who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis). As determined by the pharmacokineticist, for this analysis, 11 patients in the gluteal and 18 in the deltoids had concentration amenable to evaluation.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2607595|NCT02086786|Primary|Area Under the Curve to the Last Quantified Concentration (AUClast) for Active Moiety||Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population (patients who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis). As determined by the pharmacokineticist, for this analysis, 18 patients in the gluteal and 22 in the deltoids had concentration amenable to evaluation..|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2607596|NCT02086786|Primary|Trough Plasma Concentration (Cmin) for Active Moiety||Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population, which includes 43 patients (20 in the gluteal and 23 in the deltoid site injection group) who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis. They also had concentration data amenable to evaluation as determined by the pharmacokineticist.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2607597|NCT02086786|Primary|Peak Plasma Concentration (Cmax) for Active Moiety||Dose 1, 2 and 3: Pre-dose; at 2, 8, 12, 24 and 48 hours post-dose; 5, 7, 10, 14, 18, and 21 days post-dose. Dose 4: Pre dose; at 2, 8, 12, 24, and 48 hours post-dose; at 5, 7, 10, 14, 18, 21, 25, 28, 32, 37, 42, 60, 75, 90, 105, and 120 days post-dose.|The analysis was conducted in the PK population, which includes 43 patients (20 in the gluteal and 23 in the deltoid site injection group) who had at least 1 PK sample taken and had no major protocol deviations that would exclude them from PK analysis. They also had concentration data amenable to evaluation as determined by the pharmacokineticist.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2607598|NCT02086708|Primary|Measure Liver Elasticity Value Using Sonoelastography.|Assess liver stiffness as measured by sonoelastography with results of liver biopsy as read by a single-pathologist using the METAVIR criteria (F0-F4).|Day one||||kPa||95% Confidence Interval|Mean
2607599|NCT02086682|Primary|Clotting of Extracorporeal Dialysis Circuit|Each dialysis session was prospectively observed for Clotting of Extracorporeal Dialysis Circuit. Events were defined as interruption of hemodialysis session, loss of the hemodialysis circuit, or inability to return blood to the patient upon rinse back.|During the dialysis session, approximately 211 minutes|Units in the study referred to a dialysis session. A patient could have received dialysis more than once. Hence the number of patients (338) is less than the number of dialysis sessions (1200).|||Clotting events|Dialysis Sessions||Number
2607600|NCT02086591|Other Pre-specified|Exploratory Objective|To investigate change in plasma matrix metalloproteinase 9 (MMP9) levels as a biomarker of treatment response; to assess plasma matrix metalloproteinase 9 (MMP9) expression by immunohistochemistry (IHC) and correlate to response in order to test the hypothesis that elevated intratumoral levels of plasma matrix metalloproteinase 9 (MMP9) can predict response to doxycycline. To assess activation/expression of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kb) and Signal transducer and activator of transcription 3 (STAT 3) pathways in archived tumor by immunohistochemistry (IHC) to predict response or resistance to doxycycline.|One year|No data displayed because Outcome Measure has zero total participants analyzed||||||
2607601|NCT02086591|Secondary|Percentage of Patients With Progression Free Survival|Progression free survival is defined as the percentage of patients with stable disease or no death. Stable disease is defined as less than a partial response but is not progressive disease. Partial Response (PR)-At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses as determined byFDG-PET for CT scan. No increase should be observed in the size of other nodes, liver, or spleen. Patients who achieve a CR by the above criteria, but who have persistent morphologic bone marrow involvement will be considered partial responders. When the bone marrow was involved before therapy and a clinical CR was achieved, but with no bone marrow assessment after treatment, patients should be considered partial responders.|One year|Data was collected on all patients who were enrolled.|||percentage of participants|||Number
2607602|NCT02086591|Primary|Overall Response Rate|"Overall response rate is defined as the percentage of patients with disease progression. Progression is defined as:~Appearance of a new lesion on fluorodeoxyglucose (FDG)-positron emission tomography or computerized tomography~≥50% increase in sum of the product of the node dimensions (SPD) of more than one node or in greatest diameter of any previously identified node >1 cm in its short axis from nadir.~To be considered progressive disease, a lymph node with a diameter of the short axis of less than 1.0 cm must increase by 50% and to a size of 1.5 x 1.5 cm or more than 1.5 cm in the long axis.~At least a 50% increase in the longest diameter of any single previously identified node more than 1 cm in its short axis."|Three months||||percentage of participants|||Number
2607603|NCT02086565|Secondary|Prednisone Bursts|new prescriptions of prednisone or increases in an already-prescribed dose for an asthma exacerbation measured at baseline and at one year.|bursts at baseline and at one year|"new prescriptions of prednisone or increases in an already-prescribed dose (bursts) per year for an asthma exacerbation"|||bursts per year||95% Confidence Interval|Least Squares Mean
2607607|NCT02086565|Primary|Score of Asthma Control Questionnaire|This is a validated test with 6 items each with Likert score 0 to 6, reflecting symptoms over the past week. Lower score is a better outcome. We measured change in Asthma Control Questionnaire score from baseline to at least 12 months.|baseline and over a year|The result is the mean change in asthma control (lower is improved control) at 12 months from baseline.|||score on a scale||95% Confidence Interval|Least Squares Mean
2607608|NCT02086552|Other Pre-specified|Proportion of Patients Who Achieve MRD Negative Status|Exact binomial 95% confidence intervals for the true MRD negative rate will be calculated.|Up to 3 years|||||||
2607609|NCT02086552|Secondary|Progression-free Survival|The progression-free survival time is defined as the time from SCT to progression or death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. Here, we are reporting the proportion of patients that have not had a PFS event two years after SCT.|Time from SCT to progression or death due to any cause, assessed at 2 years|All patients that began protocol treatment and were evaluable were included in this endpoint.|||proportion of participants||95% Confidence Interval|Number
2607610|NCT02086552|Secondary|Progression-free Survival (1 Year Survival Rate)|The progression-free survival time is defined as the time from SCT to progression or death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. Here, we are reporting the proportion of patients that have not had a PFS event one year after SCT.|Time from SCT to progression or death due to any cause, assessed at 1 year|All patients that were treated and evaluable were included in this endpoint.|||proportion of participants||95% Confidence Interval|Number
2607611|NCT02086552|Secondary|Overall Survival|Overall Survival (OS) is defined as the time from Stem Cell Transplant (SCT) to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from SCT to death due to any cause, assessed up to 3 years|All patients that began protocol treatment and were eligible were included in this endpoint.|||years||95% Confidence Interval|Median
2607612|NCT02086552|Primary|Complete Response, Assessed Using the International Myeloma Working Group (IMWG) Uniform Response Criteria|"A comfirmed Complete Response (CR) is defined as a CR noted as the objective status on 2 consecutive evaluations. To be categorized as a CR, patients must exhibit the following: >~Negative immunofixation of serum and urine c, and >~Disappearance of any soft tissue plasmacytoma, and >~<5% plasma cells in Bone Marrow, and >~If the only measurable disease is the serum free light chain (FLC), a normal FLC ratio. >~We are reporting the proportion of patients achieving a CR or higher divided by the total number of evaluable patients. > Exact binomial 95% confidence intervals for the true success proportion will be calculated."|Up to 2 years|Of the 28 patients registered, one cancelled prior to treatment and 1 was ineligible due to protocol violation. Therefore 26 patients were used in this analysis.|||proportion of patients||95% Confidence Interval|Number
2607613|NCT02086162|Secondary|Number of Subjects With a Quit Attempt With 7 or More Days of Self-reported Abstinence||6 months||||Participants|||Count of Participants
2607614|NCT02086162|Secondary|Number of Subjects With Confirmed Abstinence|"Biologically confirmed abstinence: we will confirm 7-day point prevalence abstinence at 6 month assessments (self-reported abstinence without any smoking, not even a puff, for the past 7 days,) with expired carbon monoxide (reading ≤9)."|6 months||||participants|||Number
2607615|NCT02086162|Primary|Number of Subjects That Initiated Cessation Treatment|Cessation treatment initiation and engagement will be collected from clinician attendance sheets in the medical record and medical record review for prescriptions. Medication use will be confirmed with self-report of taking medication.|6 months||||participants|||Number
2607616|NCT02086110|Secondary|Serum Immune Profile Change During Prebiotic Only Treatment|"Luminex technology will be used to determine a serum immune profile of each participants in response to the study supplement. This profile included assessment of change in percentage of stimulated CD4+ T cells producing intracellular IL-13 before and after Synbiotic treatment (Post-Synbiotic % IL-13), and assessment of change in percentage of stimulated CD8+ T cells producing TNF-alpha before and after Prebiotic Only treatment (Post-Prebiotic % TNF-alpha). Results are reported here for all subjects regardless of treatment order assignment. Decrease in inflammatory cytokines IL-13 and TNF-alpha is interpreted as a positive outcome."|Five weeks|1 subject was unable to provide blood specimens throughout the study due to significant anxiety with regard to venipuncture, so only 7 subjects' serum was available for analysis.|||percentage of cytokine production||95% Confidence Interval|Median
2607617|NCT02086110|Primary|Stool Microbiota Composition Change During Synbiotic Treatment|"The stool microbiome composition will be analyzed through next generation sequencing and quantitative polymerase chain reaction. Overall bacterial composition change is reported here, as change in enterotype from before synbiotic treatment to after synbiotic treatment, for all subjects. Enterotypes were organized into four categories for analysis: a community high in Prevotella (Prevotella), a community high in Bifidobacterium (Bifidobacterium), a community high in Bacteroides (Bacteroides), and a mixed community (Mixed) that did not fall into one of the other three enterotypes but instead consisted of a varied combination of bacteria, including among others Akkermansia, Collinsela, Prevotella, and/or Bacteroides."|Five weeks|In the Prebiotic First group, 1 subject withdrew consent prior to starting synbiotic treatment. In the Synbiotic First group, 1 subject withdrew consent prior to providing stool sample, and 1 subject was unable to provide a stool sample for analysis.|||Participants|||Count of Participants
2607618|NCT02086110|Primary|Stool Microbiota Composition Change During Prebiotic Only Treatment|"The stool microbiome composition will be analyzed through next generation sequencing and quantitative polymerase chain reaction. Overall bacterial composition change is reported here, as change in enterotype from before prebiotic only treatment to after prebiotic treatment, for all subjects. Enterotypes were organized into four categories for analysis: a community high in Prevotella (Prevotella), a community high in Bifidobacterium (Bifidobacterium), a community high in Bacteroides (Bacteroides), and a mixed community (Mixed) that did not fall into one of the other three enterotypes but instead consisted of a varied combination of bacteria, including among others Akkermansia, Collinsela, Prevotella, and/or Bacteroides."|Five weeks|In the Prebiotic First group, 1 subject withdrew consent prior to providing stool sample. In the Synbiotic First group, 1 subject withdrew consent prior to starting prebiotic treatment, and 1 subject was unable to provide a stool sample for analysis.|||Participants|||Count of Participants
2609036|NCT02071095|Primary|Number Participants With Adverse Events|Safety measured by number of participants with adverse events.|Up to 48 weeks||||Participants|||Count of Participants
2607621|NCT02085785|Secondary|Acceptability|Acceptability of intervention will be assessed via a brief satisfaction survey - % who would recommend the program to a friend|At follow-up assessment (20-weeks follow-up)|Number who reported that they would recommend the program to a friend. Intervention assessment questionnaires were not linked to other study data, so we are unable to report study group information. The number analyzed are those who completed the 20-week follow-up measure.|||Participants|||Count of Participants
2607622|NCT02085785|Secondary|Feasibility - Retention|Number of randomized individuals who complete baseline and study exit visit|Follow-up assessments (all participants) and during intervention (intervention group only) (weekly, for 20 weeks)||||participants|||Number
2607623|NCT02085785|Primary|Number of Individuals That Were Randomized of Those Contacted (Feasibility)|Specific components include yield by method, recruitment rate, refusal rates and reasons|During recruitment (expected duration of 12-15 months)|313 individuals were assessed for this outcome measure. Note that the number analyzed are those that we contacted via a mailing or who contacted the study after seeing a study flyer.|||participants|||Number
2607624|NCT02085720|Secondary|Sleep and Health Questionnaire Result||1 year||||% of participants|||Number
2607625|NCT02085720|Secondary|AHI Result||1 year||||% of participants|||Number
2607626|NCT02085720|Secondary|CPAP Compliance Among Chinese Elderly|Elderly subjects who agree for home CPAP treatment are prescribed nasal CPAP units with time clocks to assess objective compliance (run time).|1 year||||hours||Standard Deviation|Mean
2607627|NCT02085720|Secondary|Prevalence of Restless Leg Syndrome (RLS)|RLS is a disorder characterized by disagreeable leg sensations that usually occur before sleep onset, causing an almost irresistible urge to move the legs. As minimal criteria for diagnosis, the following four features were required: (1) desire to move the extremities, often associated with paresthesias and/or dysesthesias; (2) motor restlessness; (3) worsening of symptoms at rest, with at least temporary relief by activity; and (4) worsening of symptoms in the evening or at night.|3 years||||% of participants|||Number
2607628|NCT02085720|Primary|Prevalence of Obstructive Sleep Apnea Syndrome in Chinese Elderly|Subjects who have completed the questionnaires and consented for sleep study are invited to undergo a portable at-home sleep study (EMBLETTA). It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea hypopnea index (AHI) based on recording time. AHI is the average number of events per hour while 5-15 events per hour denotes mild OSA, 16-30 events moderate OSA, and >30 events severe OSA. Obstructive sleep apnea syndrome is defined as AHI 15 events or above or AHI being 5 or above pulus ESS 10 or more. This measure is reporting the percentage of participants with OSAS.|3 years||||% of participants|||Number
2607629|NCT02085473|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit|Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples.|Pre-dose on Day 1 and Day 57|As-treated population included all participants who were randomized and received any study drug.|||Participants|||Count of Participants
2607630|NCT02085473|Secondary|Number of Participants Reporting Treatment-emergent Adverse Events in Laboratory Parameters|Laboratory parameters included hematology, serum chemistry and urinalysis. The treatment-emergent adverse events in laboratory parameters were reported as per investigator discretion. Treatment-emergent were the events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state.|Day 1 to Day 57|As-treated population included all participants who were randomized and received any study drug.|||Participants|||Count of Participants
2607631|NCT02085473|Secondary|Number of Participants Reporting Treatment-emergent Adverse Events Related to Vital Signs|Vital signs included systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate and temperature. The treatment-emergent adverse events related to vital signs were reported as per investigator discretion. Treatment-emergent were the events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state.|Day 1 to Day 57|As-treated population included all participants who were randomized and received any study drug.|||Participants|||Count of Participants
2607632|NCT02085473|Secondary|Number of Participants Reporting Treatment-emergent Adverse Events Related to Physical Examination|The treatment-emergent adverse events related to physical examination were reported as per investigator discretion. Treatment-emergent were the events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state.|Day 1 to Day 57|As-treated population included all participants who were randomized and received any study drug.|||Participants|||Count of Participants
2607633|NCT02085473|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly and important medical event. Treatment-emergent were events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state.|From start of study drug administration up to Day 57|As-treated population included all participants who were randomized and received any study drug.|||Participants|||Count of Participants
2607634|NCT02085473|Secondary|Number of Participants Reporting Local Injection-Site Reactions|The signs and/or symptoms of local injection-site reactions including erythema, hematoma or bleeding, local warmth, swelling, and/or rash occurring within 72 hours post-injection were assessed and recorded by a blinded assessor.|0, 10, 20, 30 and 60 minutes, 2, 4, 8, 24 and 72 hours post-injection|As-treated population included all participants who were randomized and received any study drug.|||Participants|||Count of Participants
2607666|NCT02085356|Secondary|Attendance at Scheduled Ante and Postnatal Clinic Appointments|Attendance at clinic appointments will be collected from patient records and self-report pre- and post-natal|6 months postpartum|Attendance records could not be retrieved for most participants. However, this analysis was still conducted among those participants who had data.|||Participants|||Count of Participants
2609421|NCT02065518|Primary|Lower Extremity Muscle Strength- Extension|Muscle strength was measured with a handheld dynamometer for extensor knee strength of the injured and uninjured knee.|0, 3, 6, 9, 12, and 18 weeks||||Kilograms||Standard Deviation|Mean
2607635|NCT02085473|Secondary|Local Injection-Site Pain and Injection-Site Pruritus|Local injection-site pain and pruritus intensity was rated on 0 to 100 millimeter (mm) visual analogue scale (VAS) at various time points, where 0 = no pain/ no pruritus; 100 = most severe pain/ most severe pruritus. Injection site pruritus intensity was assessed by the blinded assessor. Higher the score indicated higher intensity of pain and pruritus. Local injection site pain and pruritus was assessed at below time-points: 1 and 6 minute (min) during investigational product administration (IPA); immediately post IPA, 10, 20, 30, and 60 min, 2, 4, 8, 24 and 72 hour (h) post IPA.|During the injection until 72 hours post-injection for injection site-pain and immediately after administration of injection until 72 hours for injection-site pruritus|"As-treated population included all participants who were randomized and received any study drug. Here, N signifies number of participants analyzed for this outcome measure."|||millimole (mmol)||Standard Deviation|Mean
2607636|NCT02085473|Primary|Apparent Terminal-Phase Volume of Distribution (Vz/F)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.|Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose|The PK population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here “N” signifies participants who were evaluable for this measure.|||milliliters (mL)||Geometric Coefficient of Variation|Geometric Mean
2607637|NCT02085473|Primary|Apparent Systemic Clearance (CL/F) After Subcutaneous Dose|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after subcutaneous dose (apparent systemic clearance) is influenced by the fraction of the dose absorbed (bioavailability).|Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose|The PK population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here “N” signifies participants who were evaluable for this measure.|||milliliters per day (mL/day)||Geometric Coefficient of Variation|Geometric Mean
2607638|NCT02085473|Primary|Terminal Elimination Half-life (t1/2)|Terminal elimination half-life is the time measured for the serum concentration to decrease by one half. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose|The PK population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here “N” signifies participants who were evaluable for this measure.|||day||Geometric Coefficient of Variation|Geometric Mean
2607639|NCT02085473|Primary|Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])|AUC [0-t] is defined as area under the serum concentration-time curve from zero to last observed tralokinumab concentration.|Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose|The PK population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here “N” signifies participants who were evaluable for this measure.|||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2607640|NCT02085473|Primary|Time to Maximum Concentration (Tmax)|Tmax is defined as actual sampling time to reach maximum observed tralokinumab concentration.|Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose|The PK population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here “N” signifies participants who were evaluable for this measure.|||day||Full Range|Median
2607641|NCT02085473|Primary|Maximum Observed Serum Concentration (Cmax)|The Cmax is the maximum observed serum concentration of tralokinumab.|Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose|The PK population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here “N” signifies participants who were evaluable for this measure.|||microgram per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2607642|NCT02085473|Primary|Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])|AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero to infinite time, obtained from AUC (0 - t) plus AUC (t - infinity). Units are day*micrograms per millilitres = day*mcg/mL.|Day 1 (pre-dose sample collected within 30 minutes prior to study drug administration), Days 2, 4, 6, 8, 10, 15, 22, 36, and 57 post-dose|The Pharmacokinetic (PK) population included all participants in the as-treated population with at least one detectable tralokinumab serum concentration. Here “N” signifies participants who were evaluable for this measure.|||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2607643|NCT02085447|Secondary|Percentage Change of Days of Sub-optimal Housing in the Past Six Months; Change From Screen to Week 25|Change in number of sub-optimal housing from the past 6 months from Screen and Week 25. This is calculated by subtracting the percent of sub-optimal housing at screen from the number of sub-optimal housing at week 25.|Screen, Week 25|There is missing data for some participants on the week 25 housing status. As such, the change from screen only calculates for those who have both values, or in this case, n=20.|||percentage of days||Standard Deviation|Mean
2607644|NCT02085447|Secondary|Change in Hospitalizations (Medical) in the Past 6 Months From Screen and Week 25|Change in number of psychiatric hospitalizations from the past 6 months from Screen and Week 25. This is calculated by subtracting the number of psychiatric hospitalizations at screen from the number of psychiatric hospitalizations at week 25.|Screen, Week 25||||hospital visits||Standard Deviation|Mean
2607645|NCT02085447|Secondary|Change in Hospitalizations (Psychiatric) in the Past 6 Months From Screen and Week 25|Change in number of psychiatric hospitalizations from the past 6 months from Screen and Week 25. This is calculated by subtracting the number of psychiatric hospitalizations at screen from the number of psychiatric hospitalizations at week 25.|Screen, Week 25||||hospital visits||Standard Deviation|Mean
2607667|NCT02085356|Secondary|Mother Reported Rates of Infant Exclusive Breastfeeding|Feeding practices will be assessed at 6 weeks, and rates of exclusive breastfeeding will be assessed.|6 weeks|This refers to exclusive breastfeeding as reported by the mother.|||Participants|||Count of Participants
2607646|NCT02085447|Secondary|Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Akathisia)|For the subjective examination scoring is on a 4-point scale (0=Absent;1=Mild, 2=Moderate, 3=Severe). The evaluator takes into account the verbal report of the patient on: 1) the frequency and duration of the symptom during the day; 2) the number of days the symptom was present during the last week; and, 3) the subjective evaluation of the intensity of the symptom by the patient. The score for akathisia is separated from the Parkinsonism score and is based on the combined score of subjective akathisia (item 6 of the questionnaire) and objective akathisia (item 7 of the Parkinsonism/Akathisia objective examination). This subscore total ranges from 0 to 6. Higher scores indicate more severity.|Screen, Week 25|There is missing data for some participants on the week 25 ESRS-A. As such, the change from screen only calculates for those who have both values, or in this case, n=20.|||units on a scale||Standard Deviation|Mean
2607647|NCT02085447|Secondary|Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Dyskinesia) From Screen to Week 25|For the subjective examination scoring is on a 4-point scale (0=Absent;1=Mild, 2=Moderate, 3=Severe). The evaluator takes into account the verbal report of the patient on: 1) the frequency and duration of the symptom during the day; 2) the number of days the symptom was present during the last week; and, 3) the subjective evaluation of the intensity of the symptom by the patient. Score for TD, ranging from 0 to 42, is based on the sum of all seven items in the TD objective examination. Higher scores indicate more severe symptomology.|Screen, Week 25|There is missing data for some participants on the week 25 ESRS-A. As such, the change from screen only calculates for those who have both values, or in this case, n=20.|||units on a scale||Standard Deviation|Mean
2607648|NCT02085447|Secondary|Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Dystonia) From Screen to Week 25|For the subjective examination scoring is on a 4-point scale (0=Absent;1=Mild, 2=Moderate, 3=Severe). The evaluator takes into account the verbal report of the patient on: 1) the frequency and duration of the symptom during the day; 2) the number of days the symptom was present during the last week; and, 3) the subjective evaluation of the intensity of the symptom by the patient. The score for dystonia ranges from 0 to 60 (10 items), and is formed by including both acute and chronic dystonia, based on the dystonia examination. Higher scores indicate more severity.|Screen, Week 25|There is missing data for some participants on the week 25 ESRS-A. As such, the change from screen only calculates for those who have both values, or in this case, n=20.|||units on a scale||Standard Deviation|Mean
2607649|NCT02085447|Secondary|Change in ESRS-A (Extrapyramidal Symptoms Scale-Abbreviated; Parkinsonism) From Screen to Week 25|For the subjective examination scoring is on a 4-point scale (0=Absent;1=Mild, 2=Moderate, 3=Severe). The evaluator takes into account the verbal report of the patient on: 1) the frequency and duration of the symptom during the day; 2) the number of days the symptom was present during the last week; and, 3) the subjective evaluation of the intensity of the symptom by the patient. The score for Parkinsonism (including akathisia), ranges from 0 to 102 (17 items), and is based on all items of the Parkinsonism examination: tremor (0-48), gait and posture (0-6), postural stability (0-6), rigidity (0-24), expressive automatic movements (0-6), bradykinesia (0-6), akathisia (0-6). Higher scores indicate more severity.|Screen, Week 25|There is missing data for some participants on the week 25 ESRS-A. As such, the change from screen only calculates for those who have both values, or in this case, n=20.|||units on a scale||Standard Deviation|Mean
2607650|NCT02085447|Secondary|Change in BARS (Barnes Akathisia Rating Scale) From Screen to Week 25|This scale is used to measure the presence of akathisia, as may result from use of certain psychotropic medications. The scale contains four items and the score for each item is added to produce the total score. Total scores range from 0 to 14. Higher scores indicate more adverse outcomes.|Screen, Week 25|There is missing data for some participants on the week 25 BARS. As such, the change from screen only calculates for those who have both values, or in this case, n=20.|||units on a scale||Standard Deviation|Mean
2607651|NCT02085447|Secondary|Change in SAS (Simpson Angus Scale) From Screen to Week 25|The Simpson-Angus Scale is used to monitor for neurological and musculoskeletal side effects that may be a result of certain psychotropic medications. The scale consists of 10 questions which each can be rated on a scale of 0 to 4. Scores for each item are added to produce a total score. Total scores range from 0 to 40. Higher scores indicate more adverse outcomes.|Screen, Week 25|There is missing data for some participants on the week 25 SAS. As such, the change from screen only calculates for those who have both values, or in this case, n=20.|||units on a scale||Standard Deviation|Mean
2607652|NCT02085447|Secondary|Change in AIMS (Abnormal Involuntary Movement Scale) From Baseline to Week 25|"The AIMS is used to monitor for the development of involuntary movements that may occur as a result of certain psychotropic medication. It contains 14 items, 10 of which are rated on a scale of 0 (None) to 4 (Severe). The remaining four items are yes or no questions. Items 1 thru 7 are added for a total score, while item 8 is used as an overall severity index. Total scores range from 0 to 28. Higher scores indicate more adverse outcomes.Items 9 thru 12 provide additional information that may be useful in determining lip, jaw, and tongue movements."|Baseline, Week 25||||units on a scale||Standard Deviation|Mean
2607653|NCT02085447|Secondary|Change in SOFAS (Social and Occupational Functioning Assessment Scale) From Screen to Week 25|Evaluates social and occupational functioning on a scale of 0 (Inadequate information) to 100 (Superior functioning). It is a one-item measure.|Screen, Week 25||||units on a scale||Standard Deviation|Mean
2607654|NCT02085447|Secondary|Change in ASSIST GRS (Alcohol, Smoking and Substance Involvement Screening Test ) From Screen to Week 25|The ASSIST was used to measure drug use. A total score is derived by combining item scores (minimum score = 0; maximum score = 382). Higher scores indicate higher risk of lifestyle problems, including health.|Screen, Week 25|There is missing data for some participants on the week 25 ASSIST. As such, the change from screen only calculates for those who have both values, or in this case, n=20.|||units on a scale||Standard Deviation|Mean
2607655|NCT02085447|Secondary|Change in CGI (Clinical Global Impression) From Screen to Week 25|The CGI evaluates global psychopathology illness severity on a 7 point Likert Scale (minimum score = 1; maximum score = 7) with higher scores indicating worse pathology.|Screen, Week 25|There is missing data for some participants on the week 25 CGI. As such, the change from screen only calculates for those who have both values, or in this case, n=22.|||units on a scale||Standard Deviation|Mean
2607689|NCT02084797|Other Pre-specified|Sodium Palatability Ratings|To determine if sodium preference ratings were appropriately regulated in response to the V2R antagonist, agonist and placebo conditions during exercise.|4 weeks (4 trials)|||||||
2607656|NCT02085447|Secondary|Change in PANSS (Positive and Negative Syndrome Scale; General Psychopathology) From Screen to Week 25|The PANSS is used to assess patients for positive and negative symptoms of schizophrenia or schizoaffective disorder. The General Psychopathology Subscale consists of 16 questions. Each item is rated on a scale of 1 (Absent) to 7 (Extreme). Total scores range from 16-112 on the General Psychopathology scale. Higher scores indicate more symptoms of psychopathology. There is no aggregate score for this measure, as the subscales are to be scored separately.|Screen, Week 25|There is missing data for some participants on the week 25 PANSS. As such, the change from screen only calculates for those who have both values, or in this case, n=22.|||units on a scale||Standard Deviation|Mean
2607657|NCT02085447|Secondary|Change in PANSS (Positive and Negative Syndrome Scale; Composite Scale) From Screen to Week 25|The PANSS is used to assess patients for positive and negative symptoms of schizophrenia or schizoaffective disorder. The Composite Scale is scored by subtracting the negative score from the positive score. This yields a bipolar index that ranges from -42 to +42. The bipolar composite scale simply expresses the direction and magnitude of difference between positive and negative syndromes. Scores >0 indicate there are more positive symptoms of schizophrenia endorsed, and scores <0 indicate there are more negative symptoms of schizophrenia endorsed. There is no aggregate score for this measure, as the subscales are to be scored separately.|Screen, Week 25|There is missing data for some participants on the week 25 PANSS. As such, the change from screen only calculates for those who have both values, or in this case, n=24.|||units on a scale||Standard Deviation|Mean
2607658|NCT02085447|Secondary|Change in PANSS (Positive and Negative Syndrome Scale; Negative Symptoms Scale) From Screen to Week 25|The PANSS is used to assess patients for positive and negative symptoms of schizophrenia or schizoaffective disorder. The Negative Symptoms Subscale consists of 7 questions. Each item is rated on a scale of 1 (Absent) to 7 (Extreme). Total scores for the Negative Symptoms Subscale range from 7-49. Higher scores indicate more symptoms of psychopathology. There is no aggregate score for this measure, as the subscales are to be scored separately.|Screen, Week 25|There is missing data for some participants on the week 25 PANSS. As such, the change from screen only calculates for those who have both values, or in this case, n=24.|||units on a scale||Standard Deviation|Mean
2607659|NCT02085447|Secondary|Change in PANSS (Positive and Negative Syndrome Scale; Positive Symptoms Scale) From Screen to Week 25|The PANSS is used to assess patients for positive and negative symptoms of schizophrenia or schizoaffective disorder. The Positive Symptoms Subscale consists of 7 questions. Each item is rated on a scale of 1 (Absent) to 7 (Extreme). Total scores for the Positive Symptoms Subscale range from 7-49. Higher scores indicate more symptoms of psychopathology. There is no aggregate score for this measure, as the subscales are to be scored separately.|Screen, Week 25|There is missing data for some participants on the week 25 PANSS. As such, the change from screen only calculates for those who have both values, or in this case, n=24.|||units on a scale||Standard Deviation|Mean
2607660|NCT02085447|Secondary|Change in AMSQ (Attitudes Toward Mood Stabilizers Questionnaire) From Screen to Week 25|"The AMSQ/AMQ is used to measure attitudes towards medications. The scale contains 19 items. Responses which suggest positive attitudes towards medications are scored 0, while responses which suggest negative attitudes towards medications are scored 1. The items scores are added for a total score. Total scores range from 0 to 19. Lower total scores suggest more positive attitudes, while higher scores suggest more negative attitudes."|Screen, Week 25||||units on a scale||Standard Deviation|Mean
2607661|NCT02085447|Secondary|Change in DAI (Drug Attitudes Index) From Screen to Week 25|The DAI contains ten true-false items. Correct responses are scored as +1, while incorrect responses are scored as 0. The highest possible score is 10, while the lowest possible score is 0. Higher scores indicate better drug attitudes, while lower scores indicate worse drug attitudes.|Screen, Week 25|There is missing data for some participants on the week 25 DAI. As such, the change from screen only calculates for those who have both values, or in this case, n=23.|||units on a scale||Standard Deviation|Mean
2607662|NCT02085447|Primary|Long-acting Injection (LAI) Adherence|Long-acting injection (LAI) adherence will be determined as a proportion of LAI (paliperidone palmitate or haloperidol decanoate) injections received at the appropriate time (within 7 days of scheduled time).|Week 25|There is missing data for some participants. As such, the number analyzed for LAI adherence is n=16.|||percentage of adherence||Standard Deviation|Mean
2607663|NCT02085447|Primary|Change in Tablets Routine Questionnaire (TRQ) (Past Month) From Screen to Week 25|The Tablets Routine Questionnaire (TRQ) determines the proportion of prescribed medication taken and is not dependent upon timing of medication provided that medication is consumed within the required day/24 hour period. This rating has demonstrated statistically significant association with past non-adherence, repeated past non-adherence, any non-adherence in the past month, and non-adherence in the past week. The TRQ format will be modified slightly to document all adherence values (an exact proportion) for each item. TRQ scores ranges from perfect adherence (0% missed) to missing all medication (100% missed). An average TRQ was calculated for individuals on more than one BD medication.|Screen, Week 25|There is missing data for some participants on the week 25 TRQ. As such, the change from screen only calculates for those who have both values, or in this case, n=15.|||percentage of adherence||Standard Deviation|Mean
2607664|NCT02085447|Primary|Change in Tablets Routine Questionnaire (TRQ, Past Week) From Screen to Week 25 Visit|The Tablets Routine Questionnaire (TRQ) determines the proportion of prescribed medication taken and is not dependent upon timing of medication provided that medication is consumed within the required day/24 hour period. This rating has demonstrated statistically significant association with past non-adherence, repeated past non-adherence, any non-adherence in the past month, and non-adherence in the past week. The TRQ format will be modified slightly to document all adherence values (an exact proportion) for each item. TRQ scores ranges from perfect adherence (0% missed) to missing all medication (100% missed). An average TRQ was calculated for individuals on more than one BD medication.|Screen, Week 25|There is missing data for some participants on the week 25 TRQ. As such, the change from screen only calculates for those who have both values, or in this case, n=16.|||percentage of adherence||Standard Deviation|Mean
2607665|NCT02085356|Other Pre-specified|Self-reported Use of Condoms|Sexual behavior (i.e., condom use) will be collected by participant self-report|12 months postpartum||||Participants|||Count of Participants
2607690|NCT02084797|Other Pre-specified|Thirst Rating|To determine if fluid intake behaviors were appropriately regulated in response to the V2R antagonist, agonist and placebo conditions during exercise.|4 trials (4 weeks)|||||||
2607668|NCT02085356|Primary|Infant HIV Seroconversions|Infants will be tested for HIV at 6 weeks per the South African standard of care and at 12 months per study protocol|12 months postpartum|Medical records for tests at 6 weeks were lost by the participating clinics and therefore, medical records were considered to be unreliable. Therefore, the reported results are based on 12-month tests.|||Participants|||Count of Participants
2607669|NCT02085356|Primary|Dried Blood Spot Analysis of Medication Adherence- Mother and Infant|Presence of prescribed PMTCT protocol medications among mothers will be assessed by dried blood spot at 32 weeks gestation.|32 weeks gestation|The presence of medications via dried blood spot at 32 weeks gestation was only assessed in women, not infants, given that dried blood spots were not collected from infants.|||Participants|||Count of Participants
2607670|NCT02085252|Secondary|Change From Baseline in the International Index of Erectile Function (IIEF-5) Questionnaire Score|The IIEF-5, a 5 question patient completed questionnaire, is a measure of erectile dysfunction over the past 6 months. Each question is answered on a scale of 1 (worst) to 5 (best). Total score ranges from 5 to 25 with higher scores indicating better function (5-7: severe; 8-11: moderate; 12-16: mild to moderate;17-21: mild; 22-25: none). A positive change from baseline indicates improvement. A negative change from baseline indicates a worsening. An ANCOVA model fitted with baseline IIEF-5 score and age as covariates was used for analyses.|Baseline and Months 3, 6, 9 and 12|Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised.|||score on a scale||95% Confidence Interval|Least Squares Mean
2607671|NCT02085252|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score|The HADS is a 14-item scale that measures anxiety (7-items) and depression (7-items) over the previous week. Each question is answered on a scale of 0 (best) to 3 (worst) for a total possible score of 0 to 42, with higher scores indicating more anxiety and depression. A negative change from baseline indicates improvement. An ANCOVA model fitted with baseline HADS score and age as covariates was used for analyses.|Baseline and Months 3, 6, 9 and 12|Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised.|||score on a scale||95% Confidence Interval|Least Squares Mean
2607672|NCT02085252|Secondary|Change From Baseline in Prostate-specific Antigen (PSA) Levels|Blood was collected and sent to a central laboratory for analysis of PSA reported in milligrams/milliliter (mg/mL). A negative change from baseline indicates improvement. An ANCOVA model fitted with baseline PSA Level and age as covariates was used for analyses.|Baseline and Months 3, 6, 9 and 12|Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised.|||mg/mL||95% Confidence Interval|Least Squares Mean
2607673|NCT02085252|Secondary|Highest Diameter of the Lesion as a Measure of Tumor Radiologic Progression Using Dynamic MRI|MRI is an imaging technique used to investigate the anatomy and function of the body. Measurements were taken to determine the diameter of the lesions in millimeters (mm).|Baseline and Month 12|Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomized and for whom MRI was performed. Participants with missing MRI data are excluded from analyses. Number analyzed is the number of participants with diameter data at the given time-point.|||mm||Standard Deviation|Mean
2607674|NCT02085252|Secondary|Prostatic Volume as a Measure of Tumor Radiologic Progression Using Dynamic Magnetic Resonance Imaging (MRI)|MRI is an imaging technique used to investigate the anatomy and function of the body. Measurements were taken to calculate the prostatic volume in cubic millimeters (mm^3).|Baseline and Month 12|Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised. Participants with missing MRI data are excluded from analyses. Number analyzed is the number of participants with prostatic volume data at the given time-point.|||mm^3||Standard Deviation|Mean
2607675|NCT02085252|Secondary|Change From Baseline in the International Prostate Symptom Score (I-PSS) Total Symptom (S) Score|The I-PSS is an 8-question tool used to measure prostate symptoms (≤7: mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic). The first 7 symptom questions answered on a scale of 0 (never) to 5 (almost always) are used to determine the I-PSS Total S Score for a total possible score of 0 to 35. The 8th question is quality of life and is not reported here. A negative change from baseline indicates improvement. An Analysis of Covariance (ANCOVA) model fitted with baseline I-PSS total score and age as covariates was used for analysis.|Baseline and Months 3, 6, 9 and 12|Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised.|||score on a scale||95% Confidence Interval|Least Squares Mean
2607676|NCT02085252|Secondary|Number of Participants With Gleason Score ≥ 7|Gleason score grades prostate cancer tissue, based on its appearance under a microscope. Scores range from 2 to 10, with a higher score meaning that the cancer tissue is more likely to spread.|Month 12|Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised. Participants with missing Gleason score data are excluded.|||Participants|||Count of Participants
2607677|NCT02085252|Primary|Number of Participants With Negative Biopsies at Month 12|Staging biopsy of at least 12 cores were sampled and analyzed according to a centralized biopsy procedure which confirm the results of the first biopsy [presence of positive cores, the absence of core with tumor length > 3 millimeters (mm), and absence Grade 4 cells (Gleason score < 7)]. The Gleason score grades prostate cancer tissue, based on its appearance under a microscope. Scores range from 2 to 10, with a higher score meaning that the cancer tissue is more likely to spread.|Month 12|Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised. Participants with missing biopsy results have been excluded from the analysis.|||Participants|||Count of Participants
2607678|NCT02085161|Secondary|Resting Inspiratory Capacity (IC) Measured at 1.5 Hours Post Dose After 8 Weeks of Treatment|Resting inspiratory capacity (IC) measured at 1.5 hours post dose after 8 weeks of treatment.|Week 8|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.|||Liter||Standard Error|Least Squares Mean
2607691|NCT02084797|Other Pre-specified|Core Temperature|Measurement of core temperature using an ingestible CorTemp sensor during the V2R antagonist, agonist and placebo trials will allow researchers to assess if fluid homeostasis and thermoregulation were intertwined in response to each pharmacological intervention.|4 trials (4 weeks)|||||||
2607679|NCT02085161|Secondary|One Hour, Post-dose Forced Vital Capacity (FVC) After 8 Weeks of Treatment|One hour, Post-dose Forced Vital Capacity (FVC) after 8 weeks of treatment.|Week 8|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.|||Liter||Standard Error|Least Squares Mean
2607680|NCT02085161|Secondary|One Hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 8 Weeks of Treatment|One hour, Post-dose Forced Expiratory Volume in One Second (FEV1) after 8 weeks of treatment.|Week 8|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.|||Liter||Standard Error|Least Squares Mean
2607681|NCT02085161|Secondary|Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 12 Weeks|Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of maximum oxygen consumption (VO2 peak) after 12 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then the ANCOVA was fitted to the log10-transformed data and the least square means and SE were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean.|Week 12|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.|||Second||Standard Error|Geometric Mean
2607682|NCT02085161|Secondary|Perceived Difficulties as Evaluated With Functional Performance Inventory-Short Form (FPI-SF) Total Score at Week 12|Perceived difficulties as evaluated with FPI-SF. FPI-SF self-report questionnaire has 6 domains: Body care(5 items), Household maintenance(8 items), Physical exercise(5 items), Recreation(5 items), Spiritual activities(4 items) and Social interaction(5 items) with five possible answers on each item: Do with no difficulty - 3, Do with some difficulty - 2, Do with great difficulty - 1, don't do because of health reasons - 0, and don't do because choose not to - 0. Domain scores are expressed as mean values, with at least 6 non-missing items required for the household maintenance domain and at least 3 non-missing items for the other domains. Total score is the mean across the six domains. So total and domain scores range from 0 to 3, with higher scores indicating higher levels of functional activity within and across domains. Respondents engaged in many activities with no difficulty will score high on the FPI, while those who perform few activities with much difficulty will score low.|Week 12|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.|||Units on a scale||Standard Error|Least Squares Mean
2607683|NCT02085161|Secondary|Average Daily Walking Intensity Measured by the Activity Monitor in the Week Prior to 12 Weeks of Treatment|Average daily walking intensity measured by the activity monitor in the week prior to 12 weeks of treatment. The Movement Intensity (MI) is derived from the acceleration signals. Since seismic sensors measure gravitational acceleration (g) in static situations, the acceleration signal is expressed relative to g (1g = 9.81m/s2). To calculate movement intensity (MI) the gravitational acceleration in static situations was removed and the rotation vector of the three accelerometer signals was calculated. The MI gives an indication of the power of movements.|Week 12|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.|||Multiple of 9.8*(meters / (second^2))||Standard Error|Least Squares Mean
2607684|NCT02085161|Secondary|Average Daily Walking Time Measured by the Activity Monitor in the Week Prior to Week 12|Average daily walking time measured by the activity monitor in the week prior to Week 12.|Week 12|Full analysis set (FAS): This patient set included all patients in the TS who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.|||Second||Standard Error|Least Squares Mean
2607685|NCT02085161|Primary|Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks|Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption (VO2 peak) after 8 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then an analysis of covariance (ANCOVA) was fitted to the log10-transformed data and the least square means (LSMean) and standard error (SE) were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean.|Week 8|Full analysis set (FAS): This patient set included all patients in the Treated set (TS) who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.|||Second||Standard Error|Geometric Mean
2607686|NCT02085135|Primary|Number of Subjects With Adverse Events (AEs)||8 weeks|Number of subjects who received at least 1 dose of study drug.|||Participants|||Count of Participants
2607687|NCT02084797|Other Pre-specified|Fluid Intake|To determine if fluid intake behaviors were appropriately regulated in response to the V2R antagonist, agonist and placebo conditions during exercise.|4 weeks (4 trials)|||||||
2607688|NCT02084797|Other Pre-specified|Performance|To determine if exercise performance, as determined by overall exercise time, was affected in response to the V2R antagonist, agonist and placebo conditions.|4 trials (4 weeks)|||||||
2607692|NCT02084797|Other Pre-specified|Body Weight|Changes in body weight during the V2R antagonist, agonist and placebo conditions will provide researchers with an additional measure of overall fluid balance (fluid in versus fluid out) as well as an estimate of overall sweat water losses.|4 trials (4 weeks)|||||||
2607693|NCT02084797|Secondary|Saliva Sodium Concentration|Measurement of salivary sodium concentration will allow us to determine if the V2R antagonist, agonist and placebo interventions activate aquaporin-5 (AQP5) water channels that are also located in sweat glands. If the V2R acts on the sweat glands through AQP5, there should be parallel changes in sweat, urine and saliva sodium concentrations with each pharmaceutical intervention.|4 trials (4 weeks)||||mEq/L||Standard Deviation|Mean
2607694|NCT02084797|Secondary|Blood Sodium Concentration|Measurement of blood sodium concentration will determine if normonatremia (blood sodium concentrations within the normal physiological range of 135-145mmol/L) were maintained throughout the trial with appropriate fluid intake during the V2R antagonist, agonist and placebo intervention trials.|4 study trials (4 weeks)||||mEq/L||Standard Deviation|Mean
2607695|NCT02084797|Secondary|Urine Sodium Concentration After the Steady-state Portion of the Trial|Changes in urine sodium concentration after use of the V2R antagonist, agonist and placebo interventions will verify whether or not pharmacologic activation or inhibition was successfully induced.|4 study trials (4 weeks)||||mEq/L||Standard Deviation|Mean
2607696|NCT02084797|Primary|Sweat Sodium Concentration Obtained After the Steady-state Portion of the Trial|Changes in sweat sodium concentration will parallel changes in urine sodium concentration with use of the V2R antagonist, agonist and placebo if the primary hypothesis is true (sweat sodium is regulated by the V2R, similar to how urine sodium is regulated by principle cells located within in the kidney collecting duct)|4 study trials (4 weeks)||||mEq/L||Standard Deviation|Mean
2607697|NCT02084706|Primary|Difference in Visual-analog Score (VAS) for Anticipated Pain Prior to Injection and Actual Pain After Injection|Members of both study groups completed the Visual Analog Scale (VAS) pain assessment both prior for anticipated pain and after injection for actual pain; these recorded scores were the primary study endpoint and were later compared to determine the difference in anticipated pain versus actual pain experienced. The VAS ranges from 0-10, where 0 is no pain and 10 is worst possible pain. The outcome measure is the mean anticipated pain minus the actual pain experienced.|Our outcome measure was collected within the 60 seconds before and following the steroid injection.||||units on a scale||Standard Deviation|Mean
2607698|NCT02084628|Secondary|Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question|Diagnostic confidence was classified as not confident (No), confident (Yes), very confident (Yes).|Images were taken pre-injection and post-injection (within about 15 minutes)||||number of responses|||Number
2607699|NCT02084628|Secondary|Change in Diagnosis for the Combined Images Compared With Precontrast Images|Diagnosis based on the pre-contrast images will be indicated. If there is a change in the diagnosis based on the combined images, then the combined images diagnosis will be recorded.|Images were taken pre-injection and post-injection (within about 15 minutes)||||participants|||Number
2607700|NCT02084628|Secondary|Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by Yes or no Question||Images were taken pre-injection and post-injection (within about 15 minutes)||||participants|||Number
2607701|NCT02084628|Secondary|Contrast Enhancement of the Biliary System for the Combined Images Assessed by Yes or no Question|"Biliary system included~Gall bladder~Cystic duct~Common bile duct~Right main bile duct~Left main bile duct"|Images were taken pre-injection and post-injection (within about 15 minutes)||||number of responses|||Number
2607702|NCT02084628|Secondary|Contrast Enhancement of the Liver for the Combined Images Assessed by Yes or no Question||Images were taken pre-injection and post-injection (within about 15 minutes)||||number of responses|||Number
2607703|NCT02084628|Secondary|Number of Lesions Detected for the Combined Images||Images were taken pre-injection and post-injection (within about 15 minutes)||||number of lesions|||Number
2607704|NCT02084628|Secondary|Number of Lesions Detected for the Pre-contrast Images||Images were taken pre-injection||||number of lesions|||Number
2607705|NCT02084628|Primary|Number of Subjects With Serious Adverse Events|An serious adverse events (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|From the signing of the informed consent form until the 6 month post MRI follow-up||||participants|||Number
2607706|NCT02084628|Primary|Number of Subjects With Adverse Events|An adverse event (AE) was any untoward medical occurrence that is, any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease in a subject or clinical investigation subject after providing written informed consent for participation in the study.|From the signing of the informed consent form until the 6 month post MRI follow-up||||participants|||Number
2607707|NCT02084628|Primary|Number of Subjects With Additional Diagnostic Information From Combined (Pre-contrast And Post-contrast) Images Compared With Pre-contrast Images|Additional diagnostic information such as better delineation of the border of the lesion, better definition of the internal morphology of the lesion, better characterization of the lesion, better definition of the location of the lesion, better assessment of the communication of the lesion with respect to the biliary system obtained from the combined magnetic resonance (MR) images compared with pre-contrast MR images. Number of subjects with additional diagnostic information were recorded and analyzed.|Images were taken pre-injection and post-injection (within about 15 minutes)||||participants|||Number
2607708|NCT02084511|Secondary|Percentage of Patients With Drug-related Adverse Events|Percentage of patients with drug-related adverse events|From first drug administration until 3 days after last drug administration, upto 4 days|Treated Set|||Percentage of participants|||Number
2607709|NCT02084511|Secondary|Time to First Dose of Rescue Medication|"The time to first dose of rescue medication was defined by the difference in time of the study drug intake and the time of first rescue medication use within the first 10 h after study drug administration.~Kaplan-Meier estimates over time for each treatment and time to event endpoint 'Time to first dose of rescue medication' were presented descriptively.~Subjects without intake of rescue medication within the first 10 hours after study drug administration were censored at 10 hours."|up to 10 hours post drug administration|PD set|||hours||95% Confidence Interval|Median
2607710|NCT02084511|Secondary|Time to Meaningful Pain Relief|"Time to meaningful pain relief was captured by a stopwatch started by the trial staff immediately after administration of study medication and stopped by the subject as soon as a meaningful pain relief was felt by the subject. If a subject did not have any meaningful pain relief up to 10 h, the time was censored at 10 h.~Kaplan-Meier estimates over time for each treatment and time to event endpoint 'Time to meaningful pain relief' were presented descriptively."|up to 10 hours post drug administration|PD set|||hours||95% Confidence Interval|Median
2607711|NCT02084511|Secondary|SPID0-2h|Time-weighted sum of PID from 0 to 2 hours (SPID0-2h). SPID0-2h: possible range (-100; 200). The greater SPID0-2 the greater the reduction of pain intensity over the first 2 hours post drug administration.|up to 2 hours post drug administration|PD set|||units on scale||95% Confidence Interval|Least Squares Mean
2607712|NCT02084511|Secondary|TOTPAR0-8h|Time-weighted total pain relief (PAR) from 0 to 8 hours (TOTPAR0-8h). (TOTPAR0-8h)TOTPAR0-8h: possible range (0;32). The greater TOTPAR0-8h the more pain relief was experienced over the first 8 hours post drug administration.|up to 8 hours post drug administration|PD Set|||units on scale||95% Confidence Interval|Least Squares Mean
2607713|NCT02084511|Primary|SPID0-8h|Time-weighted sum of pain intensity difference (PID) from 0 to 8 hours post drug administration (SPID0-8h). SPID0-8h: possible range (-400; 800). The greater SPID0-8 the greater the reduction of pain intensity over the first 8 hours post drug administration.|up to 8 hours post drug administration|The pharmacodynamic set (PD set) included all subjects of the Treated set (TS) who provided at least 1 primary or secondary PD endpoint value that was not flagged for exclusion.|||units on scale||95% Confidence Interval|Least Squares Mean
2607714|NCT02084238|Secondary|Safety Assessment|Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage.|up to Day 180||2020-04-30|04/2020||||
2607715|NCT02084238|Secondary|Number of Relapses|Relapses mean that if the patient's SELENA SLEDAI Score is lower than 4 during the treatment, while the SELENA SLEDAI Score increase after stopping using the study drugs in 3 months.|24 weeks||2020-04-30|04/2020||||
2607716|NCT02084238|Secondary|SELENA SLEDAI Score|"Assessment version of the SLE Disease Activity Index (SELENA-SLEDAI) change. The higher the score represent the worse of the disease. The total score ranges from 0 to 105 points, score> 8 means the disease is moderate-to-severe active."|week 0, week 10||||score||Standard Deviation|Median
2607717|NCT02084238|Secondary|The Immunologic Impact of Low Dose IL-2 Treatment in SLE Patients|Laboratory measures were detected, including, C3, C4 and anti-dsDNA titres.|week 0 and week 10||||g/L||Full Range|Median
2607718|NCT02084238|Secondary|Immunological Responses|Analysis regulatory CD4+ T (Treg) cells , interleukin 17 (IL-17)-producing helper T (Th17) cells and follicular helper T (Tfh) cells before and during IL-2 treatment. P values below 0.05 are considered statistically significant in this study.|week 0 and week 10|regulatory CD4+ T (Treg) cells , interleukin 17 (IL-17)-producing helper T (Th17) cells and follicular helper T (Tfh) cells|||Percentage of CD4+ T cells||Full Range|Median
2607719|NCT02084238|Primary|Number of Participants Who Were SLE Responders (SRI)|SRI response was defined as (1) a ≥ 4-point reduction in SELENA-SLEDAI score, (2) no new BILAG A score or ≤ 1 new BILAG B score, and (3) no deterioration from baseline in the physician's global assessment by ≥ 0.3 points.|week 2，week 4，week 6，week 8，week 10||||participants|||Number
2607720|NCT02084160|Primary|Hepatic Decompensation Event|"Hepatic decompensation is defined as the occurrence of at least one of the following events in the time frame between the last 13C Methacetin Breath Test (MBT) to the time of data collection:~Death (liver related)~Transplantation (cadaveric and living donors)~Ascites~HE (Hepatic Encephalopathy)~Newly diagnosed varices or variceal bleeding~SBP (spontaneous bacterial peritonitis)~HRS (Hepatorenal syndrome)~HCC (hepatocellular carcinoma)~Increase in CTP (Child Turcotte Pugh) Score by 3 points~Increase in MELD score by 5 points"|5 years|Patients with advanced chronic liver disease|||number of events|||Number
2607721|NCT02084147|Primary|Radiation Dose Reduction With PET-MRI|Dose measurements will be used to calculate effective radiation dose in each patient. Dose calculations of effective dose will be used to estimate dose savings in omitting the CT component of PET-CT. Statistical tests will use a 0.10 significance level and will be 2-sided|Day 1|No data was obtained from this study group as the patient cohort was inconsistent||||||
2607722|NCT02084147|Primary|Time Effort Associated With the PET-MRI Versus PET-CT With MRI|Statistical difference in time between PET-MRI versus sequential approach for PET-CT plus MRI. Workflow with shortest timely efforts and sufficient diagnostic information will be established as routine procedure.|Day 1|No data was obtained from this study group as the patient cohort was inconsistent||||||
2607723|NCT02084147|Primary|Area Under the Receiver Operating Characteristic Curve|A two-sided z-test will be used to detect the difference in the area under the curve showing the sensitivity, specificity, positive and negative predictive values as well as accuracy of diagnostic information.|Day 1|No data was obtained from this study group as the patient cohort was inconsistent||||||
2607724|NCT02084147|Primary|Lesion Based Standard Uptake Values (SUV)|Lesion based SUV will be estimated and compared for PET-MR and PET-CT images in normal organs and compared. A two-sided two-sample t-test will be used to show significance of difference.|Day 1|No data was obtained from this study group as the patient cohort was inconsistent||||||
2607725|NCT02084147|Primary|Overall Image Quality Scores|Overall image quality scores obtained from the two imaging modalities will be compared with the hypothesis that hybrid PET-MRI images is as good as PET-CT images or superior (not inferior) to the PET-CT images. Evaluation of overall image quality will be assessed using the following criteria: 1=excellent, 2=good, 3=acceptable, 4=poor, 5=not acceptable. A Wilcoxon (Mann-Whitney) rank-sum test with a 0.100 significance level will be used.|Day 1|No data was obtained from this study group as the patient cohort was inconsistent||||||
2607726|NCT02084134|Secondary|Percentage of Patients Discharged on Glucocorticoids|Patient charts were reviewed to identify patients who were discharged on prednisone|1 day (Day of hospital discharge)||||Participants|||Count of Participants
2607727|NCT02084134|Primary|Number of Participants With Adrenal Insufficiency|Adrenal insufficiency was defined by a 30 or 60 min cortisol < 18 during a cosyntropin stimulation test|6 weeks following surgery||||Participants|||Count of Participants
2607798|NCT02083380|Other Pre-specified|Piperaquine: Cday7 Africa (> 5 Years)|Piperaquine concentration at Day7 in African patients > 5 years|Day 7||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2607728|NCT02084082|Secondary|AUC0-inf of Metformin in Plasma|"AUC0−inf(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Metformin.~The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||ng∙h/mL||Geometric Coefficient of Variation|Geometric Mean
2607729|NCT02084082|Secondary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)|"AUC0−inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Linagliptin.~The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2607730|NCT02084082|Primary|Cmax of Metformin in Plasma|Cmax (maximum measured concentration of the Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2607731|NCT02084082|Primary|Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|AUC 0-t (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||ng∙h/mL||Geometric Coefficient of Variation|Geometric Mean
2607732|NCT02084082|Primary|Maximum Measured Concentration of Linagliptin in Plasma (Cmax)|Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2607733|NCT02084082|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)|AUC 0-72 (area under concentration-time curve of the Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 1000 fast and PKS 1000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2607734|NCT02084069|Primary|Atrial Fibrillation Incidence After Open Cardiac Valve Repair||Within 5 days after open cardiac valve repair||||participants|||Number
2607735|NCT02084056|Secondary|AUC0-inf of Metformin in Plasma|"AUC0−inf(area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity) for Metformin.~The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS 2000 fast and PKS 2000 fed, included all treated subjects in Part 1 and Part 2, respectively, who provided at least 1 observation for at least 1 primary endpoint, without important protocol violations regarding the statistical evaluation of pharmacokinetic endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2607736|NCT02084056|Secondary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)|"AUC0−inf (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity) for Linagliptin.~The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2607799|NCT02083380|Other Pre-specified|Piperaquine: Cday7 Asia (All Ages)|Piperaquine concentration at Day7 in Asian patients all ages|Day 7||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2607737|NCT02084056|Primary|Cmax of Metformin in Plasma|Cmax (maximum measured concentration of Metformin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2607738|NCT02084056|Primary|Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|AUC 0-tz (Area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2607739|NCT02084056|Primary|Maximum Measured Concentration of Linagliptin in Plasma (Cmax)|Cmax (maximum measured concentration of Linagliptin in plasma) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2607740|NCT02084056|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval From 0 to 72 Hours (AUC0-72)|AUC 0-72 (area under the concentration-time curve of Linagliptin in plasma from 0 to 72 hours) The values for geometric mean and geometric coefficient of variation (gCV) are actually adjusted geometric means and adjusted intra-individual gCVs, respectively.|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h,1h 30min, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h,34h, 48h and 72h after drug administration|PKS2000 Fast and PKS2000 Fed, consists of the subjects who provided at least 1 observation for at least 1 primary endpoint without Important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2607741|NCT02083965|Secondary|Development of Inhibitor as Measured by the Nijmegen-Modified Bethesda Assay|An inhibitor test result ≥0.6 Bethesda units (BU)/mL, confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. Both tests were to be performed by the central laboratory using the Nijmegen-modified Bethesda Assay. An exact 95% confidence interval (CI) for the proportion of subjects with a confirmed inhibitor was calculated using the Clopper-Pearson method for a binomial proportion. Percentage of participants with confirmed inhibitor development was summarized overall.|Predose, Month 3, Month 6/early withdrawal. Additionally: If inhibitor suspected; at 10-15 EDs; 2-4 weeks prior to scheduled surgery; preoperatively on day of surgery; 1-2 weeks post-surgery; at last postoperative visit (last 2 for major surgery only)|The Safety Analysis Set included participants who received at least 1 dose of rFVIIIFc.|||percentage of participants||95% Confidence Interval|Number
2607742|NCT02083965|Secondary|Vz as Measured by Two-Stage Chromogenic Clotting Assay|The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||mL/kg||95% Confidence Interval|Geometric Mean
2607743|NCT02083965|Secondary|DNAUC as Measured by Two-Stage Chromogenic Clotting Assay|Dose normalized area under the FVIII activity-time curve.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
2607744|NCT02083965|Secondary|AUCext as Measured by Two-Stage Chromogenic Clotting Assay|Percentage of AUCinf extrapolated from the last data point to infinity.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||percentage of AUCinf||95% Confidence Interval|Geometric Mean
2607745|NCT02083965|Secondary|Lambda Z as Measured by Two-Stage Chromogenic Clotting Assay|First order rate constant associated with the terminal portion of the curve (lambda z).|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||1/h||95% Confidence Interval|Geometric Mean
2607746|NCT02083965|Secondary|AUClast as Measured by Two-Stage Chromogenic Clotting Assay|Area under the plasma concentration time-curve from zero to the last measured concentration.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU*h/dL||95% Confidence Interval|Geometric Mean
2607747|NCT02083965|Secondary|Tmax as Measured by Two-Stage Chromogenic Clotting Assay|Time at which maximum activity (Cmax) is observed.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||hours||95% Confidence Interval|Geometric Mean
2607748|NCT02083965|Secondary|MRT as Measured by Two-Stage Chromogenic Clotting Assay|The average time at which the number of absorbed molecules reside in the body, after single-dose administration.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||hours||95% Confidence Interval|Geometric Mean
2607749|NCT02083965|Secondary|Vss as Measured by Two-Stage Chromogenic Clotting Assay|The apparent volume of distribution at steady state. (Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.)|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||mL/kg||95% Confidence Interval|Geometric Mean
2607750|NCT02083965|Secondary|CL as Measured by Two-Stage Chromogenic Clotting Assay|The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||mL/h/kg||95% Confidence Interval|Geometric Mean
2607751|NCT02083965|Secondary|t½ as Measured by Two-Stage Chromogenic Clotting Assay|Time required for the concentration of the drug to reach half of its original value.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||hours||95% Confidence Interval|Geometric Mean
2607752|NCT02083965|Secondary|Cmax as Measured by Two-Stage Chromogenic Clotting Assay|Maximum measured concentration of rFVIIIFc.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU/dL||95% Confidence Interval|Geometric Mean
2607753|NCT02083965|Secondary|IR, K Value as Measured by Two-Stage Chromogenic Clotting Assay|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg (IR, K value), as estimated from the FVIII activity data.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
2607754|NCT02083965|Secondary|AUCinf as Estimated From the FVIII Activity Data as Measured by Two-Stage Chromogenic Clotting Assay|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU*h/dL||95% Confidence Interval|Geometric Mean
2607755|NCT02083965|Secondary|Terminal Exponential Volume of Distribution (Vz) as Measured by aPTT|The theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||mL/kg||95% Confidence Interval|Geometric Mean
2607756|NCT02083965|Secondary|Dose Normalized Area Under the Curve (DNAUC) as Measured by aPTT Clotting Assay|Dose normalized area under the FVIII activity-time curve.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
2607757|NCT02083965|Secondary|Percentage of AUCinf From the Last Data Point to Infinity (AUCext) as Measured by aPTT Clotting Assay|Percentage of AUCinf extrapolated from the last data point to infinity.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||percentage of AUCinf||95% Confidence Interval|Geometric Mean
2607758|NCT02083965|Secondary|Terminal Exponential Rate Constant (Lambda Z) as Measured by aPTT Clotting Assay|First order rate constant associated with the terminal portion of the curve (lambda z) .|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||1/h||95% Confidence Interval|Geometric Mean
2607759|NCT02083965|Secondary|Area Under the Curve to the Last Measurable Time Point (AUClast) as Measured by aPTT Clotting Assay|Area under the plasma concentration time-curve from zero to the last measured concentration.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU*h/dL||95% Confidence Interval|Geometric Mean
2607760|NCT02083965|Secondary|Time of Cmax (Tmax) as Measured by aPTT Clotting Assay|Time at which maximum activity (Cmax) is observed.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||hours||95% Confidence Interval|Geometric Mean
2607761|NCT02083965|Secondary|Mean Residence Time (MRT) as Measured by the aPTT Clotting Assay|The average time at which the number of absorbed molecules reside in the body, after single-dose administration.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||hours||95% Confidence Interval|Geometric Mean
2607762|NCT02083965|Secondary|Volume of Distribution at Steady State (Vss) as Measured by the aPTT Clotting Assay|The apparent volume of distribution at steady state. (Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.)|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||mL/kg||95% Confidence Interval|Geometric Mean
2607763|NCT02083965|Secondary|Clearance (CL) as Measured by the aPTT Clotting Assay|The measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||mL/h/kg||95% Confidence Interval|Geometric Mean
2607764|NCT02083965|Secondary|Half-life (t½) as Measured by aPTT Clotting Assay|Time required for the concentration of the drug to reach half of its original value.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||hours||95% Confidence Interval|Geometric Mean
2607765|NCT02083965|Secondary|Maximum Activity (Cmax) as Measured by the aPTT Clotting Assay|Maximum measured concentration of rFVIIIFc.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU/dL||95% Confidence Interval|Geometric Mean
2607766|NCT02083965|Primary|Incremental Recovery (IR, K Value) as Estimated From the FVIII Activity Data Measured by aPTT Clotting Assay|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg (IR, K value), as estimated from the FVIII activity data.|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU/dL||95% Confidence Interval|Geometric Mean
2607767|NCT02083965|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) as Measured by Activated Partial Thromboplastin Time (aPTT) Clotting Assay|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).|Predose, 0.5 hour (+-5 minutes); 1 hour and 6 hours (+-10 minutes); and 24, 48, 72, and 96 hours (+-60 minutes) after each injection|The Pharmacokinetic Analysis Set is defined as all eligible participants who received at least one dose of rFVIIIFc and had sufficient PK data points to calculate at least one of the PK parameters of interest from either the aPTT clotting assay or the two-stage chromogenic clotting assay.|||IU*h/dL||95% Confidence Interval|Geometric Mean
2607768|NCT02083861|Secondary|Muscle Strength Change From Baseline in Treated Knee|Muscle strength in flexion, extension, and rotation were measured using JTECH muscle testing equipment.|Baseline to 6 Weeks|17 patient subset was assessed for muscle strength pilot data.|||Newtons||95% Confidence Interval|Mean
2607968|NCT02082184|Secondary|Time Spent <70 mg/dL and <55 mg/dL|Difference in time <70 mg/dL and <55 mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA.|Baseline and Days 194 to 208||||hours per day||Standard Deviation|Mean
2607769|NCT02083861|Secondary|Range of Motion Change From Baseline in Treated Knee|JTech equipment was used to evaluate range of motion range of motion using an inclinometer (www.jtechmedical.com) in flexion and extension of the treated knee. 0 degrees is fully extended and 150 degrees is normal flexion. Positive flexion change indicates improvement in flexion. Negative extension indicates improvement in extension.|Baseline, Week 6|17 patient subset was assessed for range of motion pilot data.|||Degrees||95% Confidence Interval|Mean
2607770|NCT02083861|Secondary|Quality of Life (WOMAC) Change From Baseline|WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index). WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0-10, 0 is no pain 10 is worst pain possible for a range of 0 - 50 points. The stiffness category consists of two scores from 0-10, 0 is no stiffness 10 is worst stiffness possible for a range of 0 - 20 points. The function score consists of 17 scores from 0-10, 0 is normal function and 10 is severely limited function, for a range of 0 - 170 points. Categories were multiplied by 10 for analysis. Total score is the sum of pain, stiffness, and function scores (range of 0 - 2400).|Baseline, Week 6|Patients that completed the entire study were included in analysis.|||units on a scale||95% Confidence Interval|Mean
2607771|NCT02083861|Primary|Pain on the Numeric Rating Scale (NRS) Change From Baseline to Study Conclusion|The numeric rating scale (NRS) was used to assess change in pain from baseline to study conclusion. NRS range from 0-10 with 0 being no pain and 10 the worst pain possible.|Baseline, Week 6|Patients that completed the entire study were included in analysis.|||units on a scale||95% Confidence Interval|Mean
2607772|NCT02083679|Secondary|Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death|An adverse event (AE) was defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. AEs were considered treatment emergent if they started on or after the day of first administration of the first trial treatment given (Sym004 or one of the individual Platinum-Doublet therapies) or if they worsened after receiving first dose of treatment.|Day 1 up to 28 days after last dose of study drug (up to 53 weeks)|The safety analysis set included all 15 subjects who were administered any dose of the trial medication.|||subjects|||Number
2607773|NCT02083679|Primary|Number of Subjects With Dose Limiting Toxicities (DLTs)|DLT: any National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 Grade 4 hematologic or Grade 3/4 non-hematologic toxicities that occurred during DLT observation period and were considered by Investigator to be at least possibly related to trial treatment, and were confirmed by Safety Monitoring Committee (SMC), with exception of Grade 4 neutropenia for not >5 days; Grade 4 lymphocytopenia/ thrombocytopenia for not >5 days; fatigue/headache lasting < 7 days; nausea/vomiting/diarrhoea lasting not >3 days; asymptomatic Grade 3 increase in liver function tests that resolve to baseline within 7 days; Mucositis >= Grade 3 lasting < 7 days; Grade 3 hyperglycemia that resolves in < 7 days; any laboratory values >Grade 3 without any clinical correlate (resolve within 5 days); Grade 3 skin toxicities that resolve to Grade 2 within 7 days; Grade 3/4 hypomagnesemia that resolves within 5 days. Subjects with DLTs presented based on investigator and SMC decision.|Day 1 to Day 21 of Cycle 1|The dose limiting toxicity set included all 15 subjects in the safety analysis set (SAF) who received all planned trial medication doses during the first 21 days following the first dose of Sym004.|||Subjects|||Number
2607774|NCT02083653|Post-Hoc|Overall Survival (OS) Time for Patients in Europe + United States With Triple-Negative mCRC (EU+US TNmCRC)|"OS based on product-limit (Kaplan-Meier) estimates. Confidence intervals for the median are calculated according to Brookmeyer and Crowley.~This outcome measure is considered exploratory. Because of the unanticipated long OS in the control group, initial exploratory subgroup analyses identified that findings in patients enrolled in Russia differed when compared with patients enrolled in the ITT subpopulation and the EU+US subpopulation. For this reason, subjects in Russia were excluded from further exploratory subset analyses that evaluated the effects of genomic parameters known to impact patient responses to anti-EGFR monoclonal antibodies. Removal of the outlier Russian subpopulation of patients provided a patient population that was more homogeneous with respect to their prior treatment regimens, thereby facilitating further exploratory analyses. If a subject had not died, survival time was censored at the last date the subject was known to be alive."|From randomization until the date of death (assessed up to 32 months).|The analysis population was the EU+US TNmCRC analysis set, which is a genomically-defined subpopulation excluding DNmCRC patients with six (6) selected EGFR extracellular domain (ECD) mutations.|||months||95% Confidence Interval|Median
2607775|NCT02083653|Post-Hoc|Overall Survival (OS) Time for Patients in Europe + United States With Double-Negative mCRC (EU+US DNmCRC)|"OS based on product-limit (Kaplan-Meier) estimates. Confidence intervals for the median are calculated according to Brookmeyer and Crowley.~This outcome measure is considered exploratory. Because of the unanticipated long OS in the control group, initial exploratory subgroup analyses identified that findings in patients enrolled in Russia differed when compared with patients enrolled in the ITT subpopulation and the EU+US subpopulation. For this reason, subjects in Russia were excluded from further exploratory subset analyses that evaluated the effects of genomic parameters known to impact patient responses to anti-EGFR monoclonal antibodies. Removal of the outlier Russian subpopulation of patients provided a patient population that was more homogeneous with respect to their prior treatment regimens, thereby facilitating further exploratory analyses. If a subject had not died, survival time was censored at the last date the subject was known to be alive."|From randomization until the date of death (assessed up to 32 months).|The analysis population was the EU+US DNmCRC analysis set, which is a genomically-defined subpopulation excluding patients with high frequency clonal RAS mutations and BRAF V600E mutations.|||months||95% Confidence Interval|Median
2607801|NCT02083380|Secondary|Fever Clearance Time|Time to fever clearance (hours)|Day 42|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||hours||95% Confidence Interval|Median
2607776|NCT02083653|Secondary|Quality of Life Assessed by FACT-EGFRI-18 for Skin Rash|"Scale: Functional Assessment of Cancer Therapy-Epidermal Growth Factor Receptor Inhibitor 18 (FACT-EGFRI-18).~The FACT-EGFRI-18 is an 18-question scale used to assess EGFR-inhibitor-treated cancer patients' quality of life relative to their experience of skin rash based on three (3) multi-item subscales. The subscales combined (i.e., Symptom Index) range in score from 0 to 72. A higher score represents a high level of symptomatology (problems).~High scores for all subscales represent a worse outcome:~The Physical subscale ranges in score from 0 to 28.~The Social/Emotional subscale ranges in score from 0 to 24.~The Functional subscale ranges in score from 0 to 20."|Assessed every 3 weeks (week 1 and week 4 reported)|This measure was self-reported. Numbers analyzed between Week 1 and Week 4 differ from each other, as well from the overall number of subjects analyzed. Data could not be collected from subjects not compliant with reporting or once discontinued.|||score on a scale||Full Range|Mean
2607777|NCT02083653|Secondary|Quality of Life Assessed by EORTC QLQ-CR29|"Scale: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Colorectal Cancer Module (QLQ-CR29).~The QLQ-CR29 is a 29-question scale used to assess colorectal cancer patients' quality of life based on 22 factors (e.g., body image, anxiety, weight, etc.). The scale is composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100:~A high score for a functional scale/item represents an unhealthy level of functioning, with the exception of one (1) scale pertaining to sexual interest (separated by sex).~A high score for a symptom scale/item represents a high level of symptomatology (problems)."|Assessed every 6 weeks (week 1 and week 7 reported)|This measure was self-reported. Numbers analyzed between Week 1 and Week 7 differ from each other, as well from the overall number of subjects analyzed. Data could not be collected from subjects not compliant with reporting or once discontinued.|||score on a scale||Full Range|Mean
2607778|NCT02083653|Secondary|Quality of Life Assessed by the EORTC QLQ-C30 (Version 3)|"Scale: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (Version 3) [QLQ-C30, Version 3].~The QLQ-C30 is a 30-question scale used to assess cancer patients' quality of life based on 15 factors (e.g., global health status, physical functioning, role functioning, etc.). The scale is composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100:~A high score for a functional scale represents a healthy level of functioning.~A high score for the global health status represents a high quality of life.~A high score for a symptom scale/item represents a high level of symptomatology (problems)."|Assessed every 6 weeks (week 1 and week 7 reported)|This measure was self-reported. Numbers analyzed between Week 1 and Week 7 differ from each other, as well from the overall number of subjects analyzed. Data could not be collected from subjects not compliant with reporting or once discontinued.|||score on a scale||Full Range|Mean
2607779|NCT02083653|Secondary|Host Immune Response: Number of Subjects With Anti-drug Antibodies (ADAs) to Sym004 Over Time|A validated double antigen bridging ELISA was used for screening, confirmation, and titration of patient samples for anti-Sym004 ADA. Using rabbit anti-Sym004 as an ADA control antibody, the lower limit of detection was 54 ng/mL in the absence of Sym004 and 500 ng/mL in the presence of Sym004 at 5 µg/mL The timepoints for ADA sampling were chosen by the original sponsor for this trial. After the trial was transferred to Symphogen A/S, it was determined that not all samples were necessary for analysis. This is why the collection time points specified in the Outcome Measure Time Frame do not match with the Outcome Measure Data Table.|Every two weeks (Days 15, 29, and 43) followed by every six weeks thereafter (Days 78, 120, 162, etc.) until the End of Treatment Visit|The analysis population was the safety analysis subpopulation, which includes all subjects who were administered any dose of IMP. Subjects will be analyzed as treated and not as randomized.|||Participants|||Count of Participants
2607780|NCT02083653|Secondary|Pharmacokinetic (PK) Parameters: Time of Maximum Plasma Concentration (Tmax)|Tmax was defined as the time the PK sample was taken at end of infusion (EOI) relative to the start time of infusion (i.e., time between the start of infusion and the time of the EOI sample). For presentation of individual PK parameters and calculation of mean parameters, half of the lower limit of quantitation (LLOQ) value was used for concentration values below the LLOQ. The Sym004 serum concentration used for the PK evaluation was calculated as the sum of the serum concentrations of the 2 component monoclonal antibodies of Sym004, futuximab and modotuximab.|Day 1 on Weeks 1-3 followed by Week 5 Day 1 and Week 7 Day 1.|The analysis population was the PK analysis set, defined as subjects having at least 1 Sym004 serum concentration above the LLOQ. Exposure to Sym004 was confirmed in the majority of subjects treated with Sym004 for at least 1 timepoint post-dose.|||hours||Standard Deviation|Mean
2607781|NCT02083653|Secondary|Pharmacokinetic (PK) Parameters: Sym004 Concentrations|"The Sym004 serum concentration used for the PK evaluation was calculated as the sum of the serum concentrations of the 2 component monoclonal antibodies of Sym004 (futuximab and modotuximab).~Trough Concentration (Ctrough) is equivalent to the concentration collected at the pre-dose timepoint.~Maximum Concentration (Cmax) is equivalent to the concentration collected at the end of infusion (EOI) timepoint."|Weeks 3, 5, and 7 and at the End of Treatment visit, including a Week 1 and Week 2 subset.|The analysis population was the PK analysis set. Bioanalysis for serum concentration was done for a subset of subjects (N=19) at all scheduled timepoints; it was carried out only at Weeks 3, 5, 7 and the End of Treatment visit for all other subjects. Additionally, the Week 1 Day 1 EOI concentration for Subject 2740012 was assessed.|||ug/mL||Standard Deviation|Mean
2607782|NCT02083653|Secondary|Relative Dose Intensity of Sym004|"Treatment duration (weeks) is calculated as [(last dose date of Sym004 - first dose date of Sym004)+7] / 7 days.~Sym004 dose received (mg/kg) is calculated as (total dose administered (mg)/weight (kg)).~Dose Intensity is calculated as (cumulative Sym004 dose (mg/kg) / treatment duration (weeks)).~Relative Dose Intensity is calculated as (dose intensity / planned dose intensity at randomization)*100.~Percentages are based on the number of subjects in the safety analysis set."|From first dose of study drug until disease progression (assessed up to 32 months).|The analysis population was the safety analysis subpopulation, which includes all subjects who were administered any dose of IMP. Subjects will be analyzed as treated and not as randomized.|||percentage of relative dose intensity||Standard Deviation|Mean
2607800|NCT02083380|Secondary|PRR48|Parasite reduction ratio at 48 hours post dose|0, 6, 12, 18, 24, 30, 36 and 48 hours post dose|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. Subjects with sufficient data points to determine PRR48|||ratio||Inter-Quartile Range|Median
2607783|NCT02083653|Secondary|Occurrence and Nature of Adverse Events (AEs), as Assessed by the Common Terminology Criteria for AEs (Version 4.03) (CTCAE v4.03).|AEs were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. The incidence and type of AEs (i.e., serious AE [SAE], treatment-emergent AE [TEAE]) were summarized by dose cohort according to MedDRA system organ classes and preferred terms. An AE was considered as treatment-emergent if it occurred during or after the first IMP administration. An AE that occurred before the first IMP administration and worsened thereafter was also considered an AE. Worsening was reported as a new AE.|From Baseline up to 28 days after the last IMP administration.|The analysis population was the safety analysis subpopulation, which includes all subjects who were administered any dose of IMP, and in addition those subjects in Arm C for which the intended control treatment is BSC. Subjects will be analyzed as treated and not as randomized.|||Participants|||Count of Participants
2607784|NCT02083653|Secondary|Time to Treatment Failure (TTF)|TTF based on product-limit (Kaplan-Meier) estimates. Confidence intervals for the median are calculated according to Brookmeyer and Crowley.|From randomization until treatment discontinuation for any reason, including disease progression or death (assessed up to 32 months).|The analysis population was the ITT subpopulation, which includes all subjects who were randomized to IMP. Analyses performed on the ITT analysis set will take into account subjects' allocation to treatment groups as randomized and not as treated. Subjects who were randomized but not treated have been censored at the date of randomization.|||months||95% Confidence Interval|Median
2607785|NCT02083653|Secondary|Progression Free Survival (PFS) Time|PFS based on product-limit (Kaplan-Meier) estimates. Confidence intervals for the median are calculated according to Brookmeyer and Crowley. Death will only be considered as an event if it occurs within 12 weeks after last tumor response assessment without progression.|From randomization until first event, where an event can be a progression (radiological confirmed or clinical progression) or death due to any cause (assessed up to 32 months).|The analysis population was the ITT subpopulation, which includes all subjects who were randomized to IMP. Analyses performed on the ITT analysis set will take into account subjects’ allocation to treatment groups as randomized and not as treated.|||months||95% Confidence Interval|Median
2607786|NCT02083653|Secondary|Best Overall Response (OR) According to the Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1)|Tumor assessments were done via computed tomography (CT) or magnetic resonance imaging (MRI) scans and evaluated per RECIST v1.1. The assessment for measurable disease during screening (within 14 days prior to Day 1) acts as the baseline assessment. Best OR was summarized for each treatment group by means of counts and percentages for the following categories: Complete Response (CR: disappearance of all target lesions), Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), Progressive Disease (PD: at least a 20% increase in the sum of diameters of target lesions), Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) or Not Evaluable (NE).|From randomization until first radiological confirmed or clinical progression event, or death due to any cause, within 12 weeks after last tumor assessment (assessed up to 32 months).|The analysis population was the ITT subpopulation, which includes all subjects who were randomized to IMP. Analyses performed on the ITT analysis set will take into account subjects’ allocation to treatment groups as randomized and not as treated.|||Participants|||Count of Participants
2607787|NCT02083653|Primary|Overall Survival (OS) Time|"OS based on product-limit (Kaplan-Meier) estimates. Confidence intervals for the median are calculated according to Brookmeyer and Crowley.~If a subject had not died, survival time was censored at the last date the subject was known to be alive."|From randomization until the date of death (assessed up to 32 months).|The analysis population was the intent-to-treat (ITT) subpopulation, which includes all subjects who were randomized to investigational medicinal product (IMP). Analyses performed on the ITT analysis set will take into account subjects’ allocation to treatment groups as randomized and not as treated.|||months||95% Confidence Interval|Median
2607788|NCT02083406|Secondary|PQ Cmax|PQ Maximum observed concentration|Up to 168h post-dose|All subjects who received at least one dose of study drug and had sufficient plasma concentration data for PK parameter estimation|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2607789|NCT02083406|Secondary|Piperaquine (PQ) AUC(0-168h)|PQ Area under the plasma concentration versus time curve|Up to 168h post-dose|All subjects who received at least one dose of study drug and had sufficient plasma concentration data for PK parameter estimation|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2607790|NCT02083406|Primary|OZ439 Cmax|OZ439 Maximum observed concentration|Up to 168 hours post-dose|All subjects who received at least one dose of study drug and had sufficient plasma concentration data for PK parameter estimation|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2607791|NCT02083406|Primary|OZ439 AUC(0-168h)|OZ439 Area under the plasma concentration (AUC) versus time curve|Up to 168 hours post-dose|All subjects who received at least one dose of study drug and had sufficient plasma concentration data for pharmacokinetics (PK) parameter estimation|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2607792|NCT02083380|Other Pre-specified|Artefenomel Cday7 African Patients (>=0.5 to <= 2 Years)|Artefenomel concentration on Day 7 in African Patients >= 0.5 to <=2 years. All Treatment arms.|Day 7||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2607793|NCT02083380|Other Pre-specified|Artefenomel Cday7 African Patients (>2 to <= 5 Years)|Artefenomel concentration on Day 7 in African Patients >2 to <= 5 years. All Treatment arms.|Day 7||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2607794|NCT02083380|Other Pre-specified|Artefenomel Cday7 African Patients (> 5 Years)|Artefenomel concentration on Day 7 in African Patients > 5 years. All Treatment arms.|Day 7||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2607795|NCT02083380|Other Pre-specified|Artefenomel Cday7 Asian Patients (All Ages)|Artefenomel concentration on Day 7 in Asian Patients (all ages). All Treatment arms.|Day 7||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2607796|NCT02083380|Other Pre-specified|Piperaquine: Cday7 Africa (>=0.5 to <= 2 Years)|Piperaquine concentration at Day7 in African patients >= 0.5 and <= 2 years|Day 7||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2607797|NCT02083380|Other Pre-specified|Piperaquine: Cday7 Africa (>2 to <= 5 Years)|Piperaquine concentration at Day7 in African patients > 2 and <= 5years|Day 7||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2607802|NCT02083380|Secondary|Parasite Clearance Time|Time post dose to parasite clearance|0, 6, 12, 18, 24, 30, 36, 48 and 72 hours post dose|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||hours||95% Confidence Interval|Median
2607803|NCT02083380|Secondary|Kaplan-Meier Estimate of New Infection Rate|Kaplan-Meier estimate of number of patients with new infections|Day 63|modified Intent to Treat (mITT) population : all patients who provided written informed consent, were randomised, were compliant with the single dose combination of OZ439/PQP study drug and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.|||% population with new infection|||Number
2607804|NCT02083380|Secondary|Kaplan-Meier Estimate of Recrudescence|Kaplan-Meier estimate of number of patients with recrudescence|Day 63|modified Intent to Treat (mITT) population : all patients who provided written informed consent, were randomised, were compliant with the single dose combination of OZ439/PQP study drug and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.|||% patients with recrudescence|||Number
2607805|NCT02083380|Secondary|Kaplan-Meier Estimate of Recurrence|Kaplan-Meier estimate of number of recurrent infections (either recrudescence or new infection)|Day 63|modified Intent to Treat (mITT) population : all patients who provided written informed consent, were randomised, were compliant with the single dose combination of OZ439/PQP study drug and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.|||% population recurring|||Number
2607806|NCT02083380|Secondary|Crude ACPR at Day 63 in the ITT Population|Crude adequate clinical and parasitological response at Day 63 in the ITT population|Day 63|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.|||% ACPR unadjusted (crude)||95% Confidence Interval|Number
2607807|NCT02083380|Secondary|Crude ACPR at Day 42 in the ITT Population|Crude adequate clinical and parasitological response at Day 42 in the ITT population|Day 42|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.|||% ACPR unadjusted (crude)||95% Confidence Interval|Number
2607808|NCT02083380|Secondary|Crude ACPR at Day 28 in the ITT Population|Crude adequate clinical and parasitological response at Day 28 in the ITT population|Day 28|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.|||% ACPR unadjusted (crude)||95% Confidence Interval|Number
2607809|NCT02083380|Secondary|PCR-adjusted ACPR at Day 63 in the ITT Population|PCR-adjusted adequate clinical and parasitological response at Day 63 in the ITT population|Day 63|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
2607810|NCT02083380|Secondary|PCR-adjusted ACPR at Day 42 in the ITT Population|PCR-adjusted adequate clinical and parasitological response at Day 42 in the ITT population|Day 42|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
2607811|NCT02083380|Secondary|PCR-adjusted ACPR at Day 28 in the ITT Population|PCR-adjusted adequate clinical and parasitological response at Day 28. Intent to Treat ( ITT) population.|Day 28|Intent to Treat (ITT) population : all patients who provided written informed consent, were randomised, received the single dose combination of OZ439/PQP study drug (or part thereof), and had a confirmed positive blood film for P. falciparum asexual parasitaemia at inclusion.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
2607812|NCT02083380|Secondary|Crude ACPR at Day 63 in the PP Population|Crude adequate clinical and parasitological response at Day 63|Day 63|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. The PP population comprised 93.3% of the randomized population.|||% ACPR unadjusted (crude)||95% Confidence Interval|Number
2607813|NCT02083380|Secondary|Crude ACPR at Day 42 in the PP Population|Crude adequate clinical and parasitological response at Day 42|Day 42|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR unajusted (crude)||95% Confidence Interval|Number
2607814|NCT02083380|Secondary|Crude ACPR at Day 28 in the PP Population|Crude adequate clinical and parasitological response at Day 28|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration. The PP population comprised 93.3% of the randomized population.|||% ACPR unadjusted (crude)||95% Confidence Interval|Number
2607815|NCT02083380|Secondary|PCR-adjusted ACPR at Day 63 in the PP Population|PCR-adjusted adequate clinical and parasitological response at Day 63|Day 63|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
2607816|NCT02083380|Secondary|PCR - Adjusted ACPR at Day 42 in the PP Population|PCR - adjusted adequate clinical and parasitological response at Day 42|Days 42|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
2607817|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>= 0.5 to <= 2 Years)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.~95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
2607818|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>2 to <= 5 Years)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.~95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
2607819|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (< = 5 Years)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.~95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
2607820|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (> Than 5 Years)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.~95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
2607821|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Africa (All Ages)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.~95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
2607822|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population: Asia (All Ages)|"PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification.~95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
2607823|NCT02083380|Primary|PCR-adjusted ACPR at Day 28 in the PP Population (All Patients)|"Polymerase chain reaction (PCR)-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. Per protocol population (PP).~95% Clopper-Pearson 2-sided Confidence Interval (CI) constructed around the single binomial proportion per treatment arm and total."|Day 28|Primary analysis population was the per protocol population defined as all patients comprising the ITT set and without major protocol deviations. Including insufficient evidence of study indication, no baseline parasitemia and non-compliance with study drug administration.|||% ACPR PCR-adjusted||95% Confidence Interval|Number
2607824|NCT02083263|Secondary|Blood Gases:1 Month After Chest Physiotherapy Will Take Blood Gases (Kpa).|After physiotherapy will take blood gases (kpa) before chest physiotherapy and perform once a month.|1 month|||||||
2607825|NCT02083263|Primary|Lung Function: Lung Clearance Index|Lung clearance index was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity) required to reduce end-tidal nitrogen concentration to 1/40th of the starting value.|up to 3 months||||lung clearance index||Standard Deviation|Mean
2607932|NCT02082522|Primary|Overall Survival Time|Time from the date of randomization until the date of death or the last date the subject was known to be alive|Up to 26 months|All participants randomized (intent-to-treat population)|||days||95% Confidence Interval|Median
2607826|NCT02083185|Secondary|Change From Baseline in EORTC QLQ-C30|The EORTC QLQ-C30 included 30 questions comprising 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea/vomiting), single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties) and a global health and QOL scale. Most questions used a 4-point scale (1=Not at all to 4=Very much); 2 questions used a 7-point scale (1= Very poor to 7=Excellent). All domain scores were calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem. A positive change from Baseline in quality og life or functioning scales and negative change from Baseline in symptom or difficulties scales indicates improvement.|Day 1 of Weeks 5, 13, 25, 37, 49, 73, 97, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)|Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.|||score on a scale||Standard Deviation|Mean
2607827|NCT02083185|Secondary|Percent Change From Baseline of Aging Male Survey (AMS) Total Score|AMS scale is a self-administered questionnaire used to: 1) assess symptoms of aging (independent from those that are disease related) between groups of males under different conditions; 2) evaluate the severity of symptoms over time; and 3) measure changes before and after androgen therapy. Each question was answered between 1=none to 5=extremely severe for 17 items from psychological (5 items), somatic (7 items), and sexual (5 items) categories. Total score is sum of all the item scores and range from 17 (minimum) to 85 (maximum), where high score indicated high level of symptoms.|Baseline and Day 1 of Weeks 5,13, 25, 37 and 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)|Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.|||percent change||Standard Deviation|Mean
2607828|NCT02083185|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-P25 Score|EORTC QLQ-PR25 is an EORTC module designed to supplement the QLQ-C30 for any application in prostate cancer consisting of 25 questions distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Questions use are answered using a 4-point scale: 1=Not at all to 4 =Very much. All raw domain scores are linearly transformed to a 0 to 100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual). A positive change from Baseline in activity or functioning scales and negative change from Baseline in symptom scales indicates improvement.|Baseline and Day 1 of Weeks 5,13, 25, 37 and 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)|Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.|||score on a scale||Standard Deviation|Mean
2607829|NCT02083185|Secondary|Serum Sex Hormone-binding Globulin (SHBG) Concentrations|Blood was collected and serum concentrations of SHBG were obtained using a validated laboratory test at a central laboratory facility.|Day 1 of Weeks 2, 5, 13, 25, 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)|Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.|||nanomoles per liter (nmol/L)||Standard Deviation|Mean
2607830|NCT02083185|Secondary|Serum Follicle Stimulating Hormone (FSH) Concentrations|Blood was collected and serum concentrations of FSH were obtained using a validated laboratory test at a central laboratory facility.|Day 1 of Weeks 2, 5, 13, 25, 49, EOT (106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)|Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.|||IU/L||Standard Deviation|Mean
2607831|NCT02083185|Secondary|Serum Luteinizing Hormone (LH) Concentrations|Blood was collected and serum concentrations of LH in milli international units per milliliters (mIU/mL) were obtained using a validated laboratory test at a central laboratory facility.|Baseline and Day 4 of Week 1, Day 1 of Weeks 2, 3, 5,13, 25 and 49, End of Treatment (EOT - 106.4 Weeks), Follow-up (110.4 Weeks) and End of Study (114.4 Weeks)|Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.|||mIU/mL||Standard Deviation|Mean
2607832|NCT02083185|Secondary|TAK-385 Plasma Concentrations||Day 1 of Weeks 1, 2, 3, 5, 9, 13, 17, 25, 37, 49 pre-dose; Day 4 of Week 1 pre-dose; Day 1 of Weeks 5, 13, 2 hrs post-dose|Safety population included all randomized participants who received at least 1 dose of study drug (TAK-835). Here 'n' is the number of participants analyzed at the specific timepoint.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2607833|NCT02083185|Secondary|Time to Achieve Testosterone Concentrations < 50 ng/dL and < 20 ng/dL||During Weeks 1 to 24|Safety population included all randomized participants who received at least 1 dose of study drug. If a participant has all post first dose testosterone measurements >= 50 ng/dL, the participant’s time to castration was censored at the last testosterone measurement that is >= 50 ng/dL.|||days||Full Range|Median
2607834|NCT02083185|Secondary|Serum Prostate-Specific Antigen Concentration at the End of Weeks 12 and 24|Blood was collected and serum concentrations of PSA were obtained using a validated laboratory test at a central laboratory facility.|Day 1 of Weeks 13 and 25|Safety population included all randomized participants who received at least 1 dose of study drug. Here 'n' is the number of participants analyzed at the specific timepoint.|||μg/L||Standard Deviation|Mean
2607835|NCT02083185|Secondary|Prostate-Specific Antigen Nadir|PSA nadir is the lowest PSA achieved after treatment.|During Weeks 1 to 24|Safety population included all randomized participants who received at least 1 dose of study drug. Here number of participants analyzed are participants evaluable for this outcome measure.|||micrograms per liter (µg/L)||Standard Deviation|Mean
2607836|NCT02083185|Secondary|Percentage of Participants With Prostate-Specific Antigen (PSA) Response of ≥ 50% and ≥ 90% Reduction at 4 Weeks|PSA Response is defined as a reduction in PSA from Baseline and is reported for 2 categories: ≥ 50% reduction and ≥ 90% reduction.|Week 5, Day 1|Safety population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2607837|NCT02083185|Secondary|Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is any AE that results in death, is life threatening, requires hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.|From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks|Safety population included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
2607838|NCT02083185|Secondary|Number of Participants With TEAES Related to Clinical Laboratory Test Results|Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.|From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks|Safety population included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
2607839|NCT02083185|Secondary|Number of Participants With TEAEs Related to 12-lead Electrocardiogram (ECG) Findings|A single 12-lead ECG was performed. ECGs were read and interpreted locally and reviewed if indicated by the study monitor. ECG abnormalities were reported as AEs.|From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks|Safety population included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
2607840|NCT02083185|Secondary|Number of Participants With TEAEs Related to Physical Examination|Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10) including slit lamp examination of the anterior eye. Any TEAEs Related to physical examination were reported.|From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks|Safety population included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
2607841|NCT02083185|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs|Vital signs included oral temperature, pulse rate, supine systolic and diastolic blood pressure, standing systolic and diastolic blood pressure, and weight. Any TEAEs that were associated with vital signs were reported.|From first dose of study drug to 30 days after last dose of study drug up to 106.7 weeks|Safety population included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
2607842|NCT02083185|Primary|Percentage of Participants With Effective Castration Rate Over 24 Weeks|Effective Castration rate is defined as the observed percentage of participants who have testosterone concentrations less than (<) 50 nanogram per deciliter (ng/dL) (1.73 nanomole per liter [nmol/L]) at all scheduled visits beginning after 4 weeks of treatment.|Day 1 of Week 5 to Day 1 of Week 25|Safety population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2607843|NCT02083107|Other Pre-specified|Change in Hematocrite Value||24 hours postoperative from baseline hematocrite value||||Percentage Hematocrit||Standard Deviation|Mean
2607844|NCT02083107|Secondary|Incidence of Adverse Effects||24 hours||||no. of cases experiencing side effects|||Number
2607845|NCT02083107|Secondary|Incidence of Wound Sepsis||upto one week||||no. of cases experiencing wound sepsis|||Number
2607846|NCT02083107|Secondary|Need for Postoperative Blood Transfusion||average 24 hours||||participants|||Number
2607847|NCT02083107|Secondary|Need for Extra Analgesics||average 24 hours||||participants|||Number
2607848|NCT02083107|Secondary|Time to Resume Bowel Habits||average 24 hours||||hours||Standard Deviation|Mean
2607849|NCT02083107|Secondary|APGAR Score|The Apgar score is the first test given to a newborn, it is referred to as an acronym for: Appearance, Pulse, Grimace, Activity, and Respiration. Scores obtainable are between 10 and 0, with 10 being the highest possible score. Pulse: above 100 beats per minute (2), below 100 beats per minute (1), absent (0). Respiration: Normal rate and effort, good cry (2), Slow or irregular,weak cry (1), absent (0). Grimace: Pulls away, sneezes, coughs, or cries with stimulation (2), Facial movement only (1), absent (0). Activity: Active, spontaneous movement (2), Arms and legs flexed with little movement (1), absent (0). Appearance: Normal color (2), Normal color (but hands and feet are bluish) (1), Bluish-gray or pale all over (0).|1minute and 5 minutes from delivery of the fetus||||units on a scale||Standard Deviation|Mean
2607850|NCT02083107|Other Pre-specified|Change in Hemoglobin Concentration||24 hours postoperative from baseline hemoglobin||||gram/dL||Standard Deviation|Mean
2607851|NCT02083107|Secondary|Need for Extra Ecbolics (Oxytocin).||from start of cesarean section till the end of operation (average one hour)||||participants|||Number
2607852|NCT02083107|Primary|Intraoperative Blood Loss||from start of cesarean section till the end of operation (average one hour)||||millilitres||Standard Deviation|Mean
2607853|NCT02082977|Secondary|Part 2: Number of Participants With Progression Free Survival|PFS is defined as the interval between the first dose of study medication and the earliest date of disease progression or death due to any cause. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 3.2 years|All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.||||||
2607854|NCT02082977|Secondary|Part 2: Duration of Response|Duration of response for participants is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression or death due to any cause. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 3.2 years|All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.||||||
2607967|NCT02082184|Secondary|Frequency of Episodes <70 mg/dL and <55 mg/dL|Difference in frequency of episodes <70 mg/dL and <55 mg/dL (number per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA.|Baseline and Days 194 to 208||||number of episodes per day||Standard Deviation|Mean
2607855|NCT02082977|Secondary|Part 2: Change in 4-beta-hydroxy Cholesterol to Cholesterol Ratio From Baseline Following Repeat Dosing of GSK2816126|Plasma analysis for 4-beta-hydroxycholesterol and cholesterol was planned to be conducted. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Baseline and up to 21 days|Pharmacodynamic Population. Data was not collected in Part2 as no participant was enrolled in Part2.||||||
2607856|NCT02082977|Secondary|Part 2:Concentration of GSK2816126 in Urine After Dosing at Steady State|The amount of GSK2816126 excreted in urine after dosing at steady state was planned to be determined. The concentration of GSK2816126 in urine was planned to be measured with an investigational bio-analytical method and extrapolated to total amount excreted in urine over time using urine volume. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Pre-dose and 0 to 24 hours post-dose on Day 1; 0 to 8 hours post-dose on Day 15|Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.||||||
2607857|NCT02082977|Secondary|Part 2: Concentration of GSK2816126 and Its Metabolites in Urine|Urine samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Pre-dose and 0 to 24 hours post-dose on Day 1; 0 to 8 hours post-dose on Day 15|Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.||||||
2607858|NCT02082977|Secondary|Part 2: Concentration of GSK2816126 and Its Metabolites in Bile|Bile samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites via the Entero-Test. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Day 15|Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.||||||
2607859|NCT02082977|Secondary|Part 2: Concentration of GSK2816126 and Its Metabolites in Blood|Blood samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Pre-dose, single draw between 0.5 and 1.9 hours from start of infusion, single draw between 3-6 hours following end of infusion on Day 1; Pre-dose on Day 15 for Cycle 1 and Cycles 2, 4, 6 and 12 (Each cycle was of 28 days)|Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.||||||
2607860|NCT02082977|Secondary|Part 2: Number of Participants With Change in H3K27me3 Ratios Compared to Baseline|The pre and post-treatment samples for tumor or surrogate tissue/body fluid (e.g. PBMCs, blood, skin or hair) were planned to be collected for the analysis of H3K27me3. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was defined as any visit value minus Baseline value. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Baseline and up to 3.2 years|Pharmacodynamic Population. Data was not collected in Part2 as no participant was enrolled in Part2.||||||
2607861|NCT02082977|Secondary|Part 2:Emax of GSK2816126 With Respect to Exposure Markers|The pharmacokinetic/pharmacodynamic relationship between GSK2816126 exposure markers (dose, concentration, Cmax or AUC) was planned to be characterized by linear and/or non-linear mixed effect models. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 3.2 years|Pharmacodynamic Population. Data was not collected in Part2 as no participant was enrolled in Part2.||||||
2607862|NCT02082977|Secondary|Part 2:EC50 of GSK2816126 With Respect to Exposure Markers|The pharmacokinetic/pharmacodynamic relationship between GSK2816126 exposure markers (dose, concentration, Cmax or AUC) was planned to be characterized by linear and/or non-linear mixed effect models. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 3.2 years|Pharmacodynamic Population. Data was not collected in Part2 as no participant was enrolled in Part2.||||||
2607863|NCT02082977|Secondary|Part 2: Volume of Distribution Following Administration of GSK2816126|Blood samples were planned to be collected on Pre-dose, single draw between 0.5 and 1.9 hours from start of infusion, single draw between 3-6 hours following end of infusion on Day 1 and Day 11; Pre-dose on Day 4; Day 8,Day 11; Pre-dose on Day 15 for Cycle 1 and Cycle 2, 4, 6 and 12 pre-dose and within 5 minutes prior to end of infusion on Day 4 for population pharmacokinetic analysis of GSK2816126 including clearance. Each cycle was of 28 days. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 3.2 years|Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.||||||
2607864|NCT02082977|Secondary|Part 2: Clearance Following Administration of GSK2816126|Blood samples were planned to be collected at Pre-dose, single draw between 0.5 and 1.9 hours from start of infusion, single draw between 3-6 hours following end of infusion on Day 1 and Day 11; Pre-dose on Day 4; Day 8, Day 11; Pre-dose on Day 15 for Cycle 1 and Cycles 2, 4, 6 and 12 pre-dose and within 5 minutes prior to end of infusion on Day 4 for population pharmacokinetic analysis of GSK2816126 including clearance. Each cycle was of 28 days. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 3.2 years|Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.||||||
2607865|NCT02082977|Secondary|Part 2: Number of Participants With Abnormal Findings for ECG Parameters|Single measurements of 12-lead ECGs were planned to be obtained a semi-recumbent or semi-supine position after at least a 5 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTc intervals. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 3.2 years|All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.||||||
2607866|NCT02082977|Secondary|Part 2: Number of Participants With Abnormal Values for Vital Signs|Vital sign measurements includes SBP, DBP, body temperature and heart rate. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 3.2 years|All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.||||||
2607969|NCT02082184|Secondary|Time in Range|Difference in time in range 70-180 mg/dL between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15 time in range) using ANCOVA.|Baseline and Days 194 to 208||||hours per day||Standard Deviation|Mean
2607867|NCT02082977|Secondary|Part 2: Number of Participants With Worst Case Changes From Baseline in Hematology Parameters|Blood samples were planned to be collected for the analysis of hematology parameters including basophils, eosinophils, hematocrit, MCHC, MCH, MCV, monocytes, seg neutrophils, RBC count and reticulocytes. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Baseline and up to 3.2 years|All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.||||||
2607868|NCT02082977|Secondary|Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters|Blood samples were planned to be collected for evaluation of clinical chemistry parameters including direct bilirubin, chloride, LDH, total protein, urea/BUN and uric acid. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Baseline and up to 3.2 years|All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.||||||
2607869|NCT02082977|Secondary|Part 2: Number of Participants With Dose Reductions|The number of participants who had any dose reduction or delay were planned to be analyzed. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 3.2 years|All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.||||||
2607870|NCT02082977|Secondary|Part 2: Number of Participants With Dose Interruptions|The number of participants who had any dose interruptions were planned to be analyzed. However, this analysis was not performed for Part 2 as the study was terminated early during Part 1.|Up to 3.2 years|All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.||||||
2607871|NCT02082977|Secondary|Part 2: Number of Participants Withdrawn Due to AEs|A participant was considered to have completed the study if they have completed their end of study visit or if the participant died or was still in follow-up at the time the study was closed or terminated. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 3.2 years|All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.||||||
2607872|NCT02082977|Secondary|Part 2: Number of Participants With DLTs|An event was considered a DLT if it occurred within first 4 weeks (28 days) of treatment, and met the criteria's for hematologic , non-hematologic, infusion reactions and other toxicities, unless it can be clearly established that the event is unrelated to treatment. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 4 weeks|All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.||||||
2607873|NCT02082977|Secondary|Part 2: Number of Participants With SAEs and Non-SAEs|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 3.2 years|All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.||||||
2607874|NCT02082977|Secondary|Part 1:Concentration of GSK2816126 in Urine After Dosing at Steady State|The amount of GSK2816126 excreted in urine after dosing at steady state was determined. The concentration of GSK2816126 in urine was planned to be measured with an investigational bio-analytical method and extrapolated to total amount excreted in urine over time using urine volume. Samples were not collected due to early termination of the study; therefore, no analysis could be performed.|Pre-dose and 0 to 24 hours post-dose on Day 1; 0 to 8 hours post-dose on Day 15|Pharmacokinetic Population Samples were not collected due to early study termination.||||||
2607875|NCT02082977|Secondary|Part 1: Concentration of GSK2816126 and Its Metabolites in Urine|Urine samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites. Samples were not collected due to early termination of the study; therefore, no analysis could be performed.|Pre-dose and 0 to 24 hours post-dose on Day 1; 0 to 8 hours post-dose on Day 15|Pharmacokinetic Population. Samples were not collected due to early study termination.||||||
2607876|NCT02082977|Secondary|Part 1: Concentration of GSK2816126 and Its Metabolites in Bile|Bile samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites via the Entero-Test. Samples were not collected due to early termination of the study; therefore, no analysis could be performed.|Day 15|Pharmacokinetic Population. Samples were not collected due to early study termination.||||||
2607877|NCT02082977|Secondary|Part 1: Concentration of GSK2816126 and Its Metabolites in Blood|Blood samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites. Samples were not collected due to early termination of the study; therefore, no analysis could be performed.|Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)|Pharmacokinetic Population. Samples were not collected due to early study termination.||||||
2607878|NCT02082977|Secondary|Part 1: Percentage of Participants With Lymphoma Achieving Best Overall Response Rate|Overall response rate is defined as percentage of participants achieving complete response and partial response per RECIST version 1.1. Complete Response is the disappearance of all target/non-target lesions. Partial Response is at least a 30 percent decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. The percentage of participants with lymphoma achieving best overall response rate have been presented.|Up to 3.2 years|All Subjects Population|||Percentage of participants|||Number
2607970|NCT02082184|Primary|HbA1c at 6 Months|Difference in HbA1c between intervention and control group at day 194 adjusting for baseline HbA1c at day 1 using ANCOVA.|Baseline and Day 194||||percentage of Glycated Haemoglobin||Standard Deviation|Mean
2607879|NCT02082977|Secondary|Part 1: Percentage of Participants With Solid Tumors Achieving Best Overall Response Rate|Overall response rate is defined as percentage of participants achieving complete response and partial response per RECIST version 1.1. Complete Response is the disappearance of all target/non-target lesions. Partial Response is at least a 30 percent decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. The percentage of participants with solid tumors (including prostate) achieving best overall response rate have been presented. No participants with solid tumors were treated at doses below 800mg (i.e. 50mg, 100mg, 200mg, 400mg). Hence data could not be calculated for these 4 arms.|Up to 3.2 years|All Subjects Population.Only those participants with data available at specific time point were analyzed. No participants with solid tumors were treated at doses below 800mg (i.e. 50mg, 100mg, 200mg, 400mg). Hence data could not be calculated for these 4 arms.|||Percentage of participants|||Number
2607880|NCT02082977|Secondary|Part 1: Number of Participants With Overall Change in Tri-methylated Histone H3 Lysine 27 (H3K27me3) Ratios Compared to Baseline|The pre and post-treatment samples for tumor or surrogate tissue/body fluid (e.g. Peripheral blood mononuclear cell [PBMCs], blood, skin or hair) were collected for the analysis of H3K27me3. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was defined as any visit value minus Baseline value.|Baseline and up to 3.2 years|Pharmacodynamic Population|||Participants|||Number
2607881|NCT02082977|Secondary|Part 1: Maximum Effect (Emax) of GSK2816126 With Respect to Exposure Markers|The pharmacokinetic/pharmacodynamic relationship between GSK2816126 exposure markers (dose, concentration, Cmax or AUC) was characterized by linear and/or non-linear mixed effect models. This analysis was planned but not performed as the pharmacodynamic response was not observed and therefore a relationship between pharmacokinetic and pharmacodynamic parameters could not be determined.|Up to 3.2 years|Pharmacodynamic Population. Analysis was not performed as pharmacodynamic response was not observed.||||||
2607882|NCT02082977|Secondary|Part 1: Exposure Producing 50 Percent of the Maximum Effect (EC50) of GSK2816126 With Respect to Exposure Markers|The pharmacokinetic/pharmacodynamic relationship between GSK2816126 exposure markers (dose, concentration, Cmax or AUC) was planned to be characterized by linear and/or non-linear mixed effect models. This analysis was planned to be based on Pharmacodynamic Population which consists of participants in the All Subjects population for whom a pharmacodynamics/biomarkers sample was obtained and analyzed. This analysis was planned but not performed as the pharmacodynamic response was not observed and therefore a relationship between pharmacokinetic and pharmacodynamic parameters could not be determined.|Up to 3.2 years|Pharmacodynamic Population. Analysis was not performed as pharmacodynamic response was not observed.||||||
2607883|NCT02082977|Secondary|Part 1: Time Invariance Ratio Following Administration of GSK2816126|Ratio of AUC(0-tau) on Day15/Day1 AUC(0-inf) was calculated to assess time invariance. Only those participants with data available at specified data points were analyzed. To assess time invariance based on ANOVA method, it is required that at least 2 participants in a dose level had AUC(0-inf) on Cycle1 Day1 and AUC(0-tau) on Cycle1 Day15. For dose 100mg, 200mg and 400mg, only 1 participant received treatment. For 50mg, 2 participants received treatment but there was one participant whose AUC(0-tau) on Cycle1 Day15 could not be derived due to discontinuation of treatment before Day15, so time invariance could not be calculated. For 1200mg, 4 participants received treatment, however, AUC(0-inf) derivation on Cycle1 Day1 for 3 out of 4 participants did not strictly conform to the prescribed acceptance criteria. Time invariance ratio of GSK2816126 was estimated by calculating ratio of GLS means of AUC between Day15 and Day1 for all dose levels and corresponding 90% CI for each ratio.|Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)|Pharmacokinetic Population. To assess time invariance by ANOVA, it requires at least 2 participants to have AUC(0-inf) and AUC(0-tau) on Cycle1 Day15 which was not observed for dose 50mg, 100mg, 200mg, 400mg. For 1200mg, AUC(0-inf) on Cycle1 Day1 for 3 participants did not meet acceptance criteria. Data could not be calculated for these 5 arms.|||Ratio of AUC||90% Confidence Interval|Number
2607884|NCT02082977|Secondary|Part 1: Accumulation Ratio Following Administration of GSK2816126|Accumulation ratio was determined from the ratio of AUC (0-tau) on Cycle 1 Day 15/AUC (0-tau) on Cycle 1 Day 1 by dose cohort. Only those participants with data available at the specified data points were analyzed. To assess accumulation ratio for a dose level based on ANOVA method, it was required that at least 2 participants had derived PK parameter AUC(0- tau) on both Cycle 1 Day 1 and Cycle 1 Day 15. For dose 100mg, 200mg and 400mg, only 1 participant received treatment. For dose 50mg, 2 participants received treatment but there was one participant whose AUC(0- tau) on Cycle 1 Day 15 could not be derived due to discontinuation of treatment before Day 15. Hence, accumulation ratio could not be calculated for these 4 arms. Accumulation ratio of GSK2816126 was estimated by calculating the ratio of geometric least squares (GLS) means of the AUC between Day 15 and Day 1 for all dose levels and corresponding 90 percent (%) confidence interval (CI) for each ratio.|Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)|Pharmacokinetic Population. To assess accumulation ratio by ANOVA, it requires at least 2 participants to derive PK parameter AUC(0- tau) on both Cycle 1 Day 1 and Cycle 1 Day 15 which was not observed for dose 50mg, 100mg, 200mg and 400mg. Hence data could not be calculated for these 4 arms.|||Ratio of AUC||90% Confidence Interval|Number
2607885|NCT02082977|Secondary|Part 1: Apparent Terminal Phase Half-life (T1/2) Following Single and Repeat Dose Administration of GSK2816126|Blood samples were collected from participants for pharmacokinetic analysis including T1/2 following single (Day 1) and repeat dose (Day 15) administration of GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. Pharmacokinetic parameter derivation for some participants did not strictly conform to the prescribed acceptance criteria and hence data was not available for those participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)|Pharmacokinetic Population|||Hours||Full Range|Median
2607886|NCT02082977|Secondary|Part 1: Apparent Terminal Phase Elimination Rate Constant (Lambda z) Following Single and Repeat Dose Administration of GSK2816126|Blood samples were collected from participants for pharmacokinetic analysis including lambda z following single (Day 1) and repeat dose (Day 15) administration of GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. Pharmacokinetic parameter derivation for some participants did not strictly conform to the prescribed acceptance criteria and hence data was not available for those participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)|Pharmacokinetic Population|||Hours^-1||Full Range|Median
2607887|NCT02082977|Secondary|Part 1: Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of GSK2816126|Blood samples were collected from participants for pharmacokinetic analysis including Tmax following single (Day 1) and repeat dose (Day 15) administration of GSK2816126. Tmax is the time to reach Cmax, determined directly from the concentration-time data. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)|Pharmacokinetic Population|||Hours||Full Range|Median
2607888|NCT02082977|Secondary|Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of GSK2816126|Blood samples were collected from participants for pharmacokinetic analysis including Cmax following single (Day 1) and repeat dose (Day 15) administration of GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)|Pharmacokinetic Population|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2607889|NCT02082977|Secondary|Part 1: Trough (Pre-dose) Concentration at the End of Dosing Interval on the Specified Days (Ctau) Following Administration of GSK2816126|Blood samples were collected from participants for pharmacokinetic analysis including Ctau following specified days (Days 8 and 15) administration of GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. NA indicates data was not available as data could not be calculated due to limited number of participants at specified data point. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose from start of infusion till end of infusion on Cycle 1 of Day 8; Pre-dose, 0.5, 1, 2, 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 15 (Each cycle was of 28 days)|Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.|||Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2607890|NCT02082977|Secondary|Part 1: Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0-tau]) Following Repeat Dose Administration of GSK2816126|Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-tau) following repeat (Day 15) dose administration of GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.|Pre-dose, 0.5, 1, 2, 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 15 (Each cycle was of 28 days)|Pharmacokinetic Population. Only those participants with data available at specific time point were analyzed.|||Hour*Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2607891|NCT02082977|Secondary|Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of GSK2816126|Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-infinity) following single (Day 1) dose administration of GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant. Pharmacokinetic parameter derivation for some participants did not strictly conform to the prescribed acceptance criteria and hence data was not available for those participants.|Pre-dose, 0.5, 1, 2, 12, 18 , 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 (Each cycle was of 28 days)|Pharmacokinetic Population. Only those participants with data available at specific time point were analyzed.|||Hour*Microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2607892|NCT02082977|Secondary|Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) Following Single and Repeat Dose Administration of GSK2816126|Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-t) following single (Day 1) and repeat dose (Day 15) administration of GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. The analysis was performed on Pharmacokinetic Population which included all participants in the All Subject population for whom a blood sample for pharmacokinetics was analyzed and at least 1 non-missing values was obtained. NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)|Pharmacokinetic Population|||Hour*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2607893|NCT02082977|Primary|Part 2: Percentage of Participants Achieving Overall Response Rate|Overall response rate is defined as percentage of participants achieving complete response and partial response per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 3.2 years|All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.||||||
2607894|NCT02082977|Primary|Part 1: Number of Participants With Abnormal Findings for Electrocardiogram (ECG) Parameters|Single measurements of 12-lead ECGs were obtained a semi-recumbent or semi-supine position after at least a 5 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT (QTc) intervals. The number of participants with abnormal, abnormal-not clinically significant (NCS), and abnormal-clinically significant (CS) worst case Post Baseline findings have been presented.|Up to 3.2 years|All Subjects Population|||Participants|||Number
2607895|NCT02082977|Primary|Part 1:Number of Participants With Abnormal Values for Vital Signs|Vital sign measurements includes systolic blood pressure (SBP), diastolic blood pressure (DBP), body temperature and heart rate. Vital signs were measured after resting for at least 5 minutes in a semi-supine position. The number of participants with abnormal findings for vital signs have been presented.|Up to 3.2 years|All Subjects Population|||Participants|||Number
2607896|NCT02082977|Primary|Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters|Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, hematocrit, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes, segmented (seg) neutrophils, red blood cell (RBC) count and reticulocytes. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are not gradable by CTCAE version 4.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 3.2 years|All Subjects Population|||Participants|||Number
2607897|NCT02082977|Primary|Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters|Blood samples were collected for evaluation of clinical chemistry parameters including direct bilirubin, chloride, lactate dehydrogenase (LDH), total protein, urea/blood urea nitrogen (BUN) and uric acid. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are not gradable by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 3.2 years|All Subjects Population|||Participants|||Number
2607898|NCT02082977|Primary|Part 1: Number of Participants With Dose Reductions|The number of participants who had any dose reductions have been presented.|Up to 3.2 years|All Subjects Population|||Participants|||Number
2607899|NCT02082977|Primary|Part 1: Number of Participants With Dose Interruptions|The number of participants who had any dose interruptions have been presented.|Up to 3.2 years|All Subjects Population|||Participants|||Number
2607900|NCT02082977|Primary|Part 1: Number of Participants Withdrawn Due to AEs|A participant was considered to have completed the study if they have completed their end of study visit or if the participant died or was still in follow-up at the time the study was closed or terminated. Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to AEs have been presented.|Up to 3.2 years|All Subjects Population|||Participants|||Number
2607901|NCT02082977|Primary|Part 1: Number of Participants With Dose Limiting Toxicities (DLT)|An event was considered a DLT if it occurred within first 4 weeks (28 days) of treatment, and met the criteria's for hematologic , non-hematologic, infusion reactions and other toxicities, unless it can be clearly established that the event is unrelated to treatment.|Up to 4 weeks|All Subjects Population|||Participants|||Number
2607902|NCT02082977|Primary|Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. The analysis was performed on All Subjects Population which included all participants who received at least one dose of study treatment.|Up to 3.2 years|All Subjects Population|||Participants|||Number
2607903|NCT02082912|Secondary|Number of Blocks Moved During the Box and Block Test (BBT) of Affected Arm|Change in functional motor task performance of the arm affected by the stroke was assessed with the Box and Block Test (BBT). The BBT involves dexterous manipulation of objects and voluntary motor control, which improves with upper limb recovery following stroke. The number of blocks moved within 60 seconds are counted. Baseline scores of the mean number of blocks moved are presented in the Outcome Measure Data Table and the impact of the study arm at Day 30 is presented in the statistical analysis section.|Baseline, Day 30|Participants completing the study are included in this analysis.|||blocks per minute||Standard Deviation|Mean
2607904|NCT02082912|Secondary|Display Enhanced Testing for Concussions and Mild Traumatic Brain Injury (mTBI) (DETECT) System Score|"Using a computer, helmet with heads-up-display, headphones with audio inputs, and an input unit with two buttons (Yes and No), the DETECT system combines an immersive environment with neuropsychological tests to assess mTBI. The DETECT software consists of a series of tests evaluating information processing speed, episodic memory, and working memory. Performance is scored based on response type (correct, incorrect, and missing) and response time. Test results are displayed using an internal algorithm that is based on the probability of impairment. Mean baseline z-scores are presented in the Outcome Measure Data Table and the impact of the study arm at Day 30 is presented in the statistical analysis section. A z-score of 0 represents a healthy individual; scores above 0 are the number of standard deviations above the mean, indicating more errors, taking more time, and thus having a higher probability of mild cognitive impairment."|Baseline, Day 30|Participants with complete information for the DETECT measurement are included in this analysis. Two participants had missing values dues to technical issues with the instrument.|||z-score||Standard Deviation|Mean
2607905|NCT02082912|Secondary|Center for Epidemiologic Studies Depression (CES-D) Scale Score|Depressive symptoms were assessed with the Center for Epidemiologic Studies Depression (CES-D) Scale. The CES-S has 20 items rated on a scale of 0 to 3. Total scores range from 0 to 60 with higher scores indicating more depressive symptoms, and a score of 16 or above indicates depression. Baseline scores are presented in the Outcome Measure Data Table and the impact of the study arm at Day 30 is presented in the statistical analysis section.|Baseline, Day 30|Participants completing the study are included in this analysis.|||units on a scale||Standard Deviation|Mean
2607906|NCT02082912|Secondary|Percentage of Stroke Impact Scale (SIS) Categories Meeting Change Criteria|The percentages of Stroke Impact Scale (SIS) physical domain categories meeting criteria for Minimal Clinically Important Difference (MCID) are presented here. The SIS has 59 items in 8 domains of function where respondents rate their degree of difficulty on a 5-point scale, plus a 9th category for stroke recovery (one item, scored from 0 to 100). Scores for each domain are generated so that total scores for each domain range from 0 - 100, where higher scores indicate less difficulty and more recovery. A change of more than 4.5 to 17.8 for the domains was considered a MCID. A higher percentage of SIS categories meeting the MCID criteria indicates increased improvement in that study arm.|Baseline, Day 30|Participants completing the study are included in this analysis.|||percentage of category scores|||Number
2607907|NCT02082912|Primary|Grip Strength of Affected Hand|Hand-grip strength was assessed using the whole hand and was defined as the average of 3 trials using a calibrated Jamar dynamometer (Jamar Dynamometer, Asimow Engineering Co., Santa Monica, CA), with the elbow flexed to 90º and the forearm in a neutral position. This is the standardized method for measuring hand-grip strength with a Jamar dynamometer recommended by the American Society of Hand Therapists. An increase in values means that grip strength is improving.|Baseline, Day 30|Participants completing the study are included in this analysis.|||Newton||Standard Deviation|Mean
2607908|NCT02082769|Other Pre-specified|Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline||Baseline and Final Visit (up to 26 weeks)||||umol/l||Standard Deviation|Mean
2607909|NCT02082769|Secondary|Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit||Final Visit (up to 26 weeks)||||percentage of participants|||Number
2607910|NCT02082769|Primary|Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)||Last 3 visits (any last 3 visits up to week 26)||||percentage of participants|||Number
2607911|NCT02082522|Secondary|Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30|Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.|Baseline, 78 weeks|No data collected||||||
2607912|NCT02082522|Secondary|Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30|Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.|Baseline, 66 weeks|No data collected||||||
2607913|NCT02082522|Secondary|Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30|Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.|Baseline, 54 weeks|Due to the premature termination of the study, there was insufficient data to allow statistical analysis.|||score on a scale||Standard Deviation|Mean
2607914|NCT02082522|Secondary|Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30|Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.|Baseline, 41 weeks|Due to the premature termination of the study, there was insufficient data to allow statistical analysis.|||score on a scale||Standard Deviation|Mean
2607915|NCT02082522|Secondary|Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30|Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.|Baseline, 29 weeks|Due to the premature termination of the study, there was insufficient data to allow statistical analysis.|||score on a scale||Standard Deviation|Mean
2607916|NCT02082522|Secondary|Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30|Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.|Baseline, 16 weeks|Due to the premature termination of the study, there was insufficient data to allow statistical analysis.|||score on a scale||Standard Error|Mean
2607917|NCT02082522|Secondary|Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30|Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.|Baseline, 13 weeks|Due to the premature termination of the study, there was insufficient data to allow statistical analysis.|||score on a scale||Standard Deviation|Mean
2607918|NCT02082522|Secondary|Change From Baseline in Health-related Quality of Life on the 4- and 7-point EORTC QLQ-C30|Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.|Baseline, up to 4 weeks|Not collected||||||
2609616|NCT02063867|Other Pre-specified|Urinary Tract Infections|Urinary tract infections attributable to participating units. Defined as occurring >2 days into a participating unit stay through 2 days following unit discharge|21 months|||||||
2607919|NCT02082522|Secondary|Change From Baseline in Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)|Final European Organisation for Research and Treatment of Cancer (EORTC) scores for multi-item scales and single-item measures will range from 0 to 100. This questionnaire assesses the quality of life of cancer patients. A high score represents a high/healthy level of functioning, basically a high Quality of Life.|Baseline, 7 days|Due to the premature termination of the study, there was insufficient data to allow statistical analysis.|||score on a scale||Standard Deviation|Mean
2607920|NCT02082522|Secondary|Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)|The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.|Baseline, 78 weeks|Not collected||||||
2607921|NCT02082522|Secondary|Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)|The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.|Baseline, 66 weeks|Data not collected||||||
2607922|NCT02082522|Secondary|Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)|The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.|Baseline, 54 weeks|At 54 weeks, only 1 subject in each group was measured. Due to the premature termination of the study, there was insufficient data to allow statistical analysis.|||score on a scale||Standard Deviation|Mean
2607923|NCT02082522|Secondary|Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)|The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.|Baseline, 41 weeks|At 41 weeks, 2 subjects in the PDT +SMC group were analysed and 1 in the SMC Alone group was analysed. Due to the premature termination of the study, there was insufficient data to allow statistical analysis.|||score on a scale||Standard Deviation|Mean
2607924|NCT02082522|Secondary|Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)|The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.|Baseline, 29 weeks|At 29 weeks, 6 subjects in the PDT +SMC group were analysed and 5 in the SMC Alone group were analysed. Due to the premature termination of the study, there was insufficient data to allow statistical analysis.|||score on a scale||Standard Deviation|Mean
2607925|NCT02082522|Secondary|Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)|The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death.|Baseline, 16 weeks|At 16 weeks, 9 subjects in the PDT +SMC group were analysed and 9 in the SMC Alone group were analysed. Due to the premature termination of the study, there was insufficient data to allow statistical analysis.|||score on a scale||Standard Deviation|Mean
2607926|NCT02082522|Secondary|Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)|The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death.|Baseline, 13 weeks|At 13 weeks, 8 subjects in the PDT +SMC group were analysed and 8 in the SMC Alone group were analysed. Due to the premature termination of the study, there was insufficient data to allow statistical analysis.|||score on a scale||Standard Deviation|Mean
2607927|NCT02082522|Secondary|Change From Baseline in Performance Status on the Karnofsky Performance Scale (KPS)|The Karnofsky Performance Scale (KPS) scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. A score of 100% means there are no complaints and no evidence of disease. A score of 80% means there is normal activity with effort and some signs or symptoms of disease. A score of 0% means death.|Baseline, up to 4 weeks|At 4 weeks, 12 subjects in the PDT +SMC group were analysed and 9 in the SMC Alone group were analysed.|||score on a scale||Standard Deviation|Mean
2607928|NCT02082522|Secondary|Change From Baseline on Karnofsky Performance Scale (KPS)|The Karnofsky Performance Scale scores range from 0% to 100%. The lower the Karnofsky score, the worse likelihood of survival. However, the premature termination of the study does not allow for a meaningful analysis of the scale where 100% means no complaints with no evidence of disease, 80% is normal activity with effort and some signs or symptoms of disease.|Baseline, 7 days|At Day 7, all 15 subjects in the PDT +SMC group were analysed and 9/13 in the SMC Alone group were analysed.|||score on a scale||Standard Deviation|Mean
2607929|NCT02082522|Secondary|Time-to-tumor Progression|From the date of first documented response until the date that tumor progression was assessed|Up to 26 months|Not collected||||||
2607930|NCT02082522|Secondary|Best Overall Tumor Response as Measured by the RECIST 1.1 Criteria (Response Evaluation Criteria in Solid Tumors)|From the start of the treatment until disease progression or recurrence the RECIST 1.1 criteria are applied (Response Evaluation Criteria in Solid Tumors)|Up to 26 months|Due to the premature termination of the study, there was insufficient data to allow statistical analysis.|||percentage of participants|||Number
2607931|NCT02082522|Secondary|Time-to-bilirubin Response|From the date of randomization until the date of first documented bilirubin response|Up to 30 days|Data not collected||||||
2607933|NCT02082483|Other Pre-specified|Number of Health Care Encounters|The information captured will include outpatient, day care, and emergency room use (including any diagnostic testing and all medical and surgical interventions (i.e. use of thrombolytics, revascularization procedures), inpatient encounters and resource utilization (hospitalizations, procedural costs), physician consultations. Indirect patients costs (time off work, transportation costs), and quality of life (measured using the short-form 36 (SF36).|Up to 27 months|||||||
2607934|NCT02082483|Other Pre-specified|Number of Participants With Wait List Holds or Removals|Indication for hold or removal will be measured as well.|Up to 24 months||||Participants|||Count of Participants
2607935|NCT02082483|Other Pre-specified|Number of Participants With Transplant Events|Patient transplantation will be documented on the subject case report form.|Up to 24 months||||Participants|||Count of Participants
2607936|NCT02082483|Secondary|Number of Participants With Cardiac Events|A composite outcome of cardiac death and non-fatal myocardial infarction will be looked at and adjudicated by a blinded clinical endpoints committee.|Up to 27 months||||Participants|||Count of Participants
2607937|NCT02082483|Primary|Consent Rate|The percentage of patients willing to participate will be established at each site. Willingness to enrol in the study will be recorded on each patient's case report form along with the reason for any refusal to consent.|Measured after enrolment period of 6 months|Number of participants approached to consent to study.|||Participants|||Count of Participants
2607938|NCT02082483|Primary|Enrolment Rates|The total number of subjects enrolled across all sites will be monitored monthly from the CRO, Ottawa Hospital Research Institute (OHRI), which issues the randomization scheme.|Measured after enrolment period of 6 months||||Participants|||Count of Participants
2607939|NCT02082483|Primary|Number of Participants Adhering to the Expected Number of Screening Tests|Adherence will be defined by completion of the expected number of screening tests during follow up as per the 2005 National Kidney Foundation guidelines. For example, the expected number of screening tests in a diabetic patient who did not develop symptoms would be zero in the selective screening group, while the same patient would be expected to completed two screening tests if randomized to regular screening. Tests performed for clinical symptoms of CAD will be excluded from the determination of adherence.|Up to 27 months||||participants|||Number
2607940|NCT02082392|Secondary|Blind Assessment—Patient Version|rates subject's guess as to the identity of study medication and the confidence in that guess. This assessment is necessary to document the effectiveness of the study's methods of treatment allocation concealment.|8 weeks|Data were not collected||||||
2607941|NCT02082392|Secondary|California Pharmacotherapy Alliance Scale (CALPAS)—Patient Version|24 item Likert scale rating the patient's assessment of the therapeutic alliance, particularly about medication issues, with the clinician. This scale is superior to other therapeutic alliance scales because it is focused on drug treatment and does not contain items specific to psychotherapy.|8 weeks|Data were not collected||||||
2607942|NCT02082392|Secondary|Schedule for Adaptive and Nonadaptive Personality (SNAP)|this questionnaire is a widely used assessment tool for personality disorders that we will also use to identify predictors of response to varying visit frequency.|8 weeks|Data were not collected||||||
2607943|NCT02082392|Secondary|Revised Life Orientation Test (LOT-R)|scale developed to assess individual differences in generalized optimism versus pessimism. Degree of optimism on this scale has been correlated with the magnitude of placebo response observed in studies of placebo analgesia, and we will determine whether LOT-R scores moderate effects of therapeutic contact.|8 weeks|Data were not collected||||||
2607944|NCT02082392|Secondary|Cornell Treatment Preference Index|"scale used in mental health studies to document the type and strength of patients' treatment preferences. We will use a modified version in this study asking subjects Based on your experience and how you feel right now, which of the visit frequencies in this study would be your first choice? The strength of this preference will be measured on a 5-point Likert scale."|8 weeks|Data were not collected||||||
2607945|NCT02082392|Secondary|Client Satisfaction Questionnaire 8 (CSQ 8)|self-administered scale with items rating respondents' satisfaction with mental health services they are receiving on a 4 point Likert scale. Use of the CSQ 8 will allow us to determine whether CFM and RFM are associated with differences in participant satisfaction.|8 Weeks|Data were not collected||||||
2607946|NCT02082392|Secondary|Treatment Credibility and Expectancy Scale (CES)|"8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. For this study, the primary measure of expectancy will be item 4: By the end of the treatment period, how much improvement in your depressive symptoms do you think will occur? (0-100%)."|8 Weeks|Data were not collected||||||
2607947|NCT02082392|Secondary|Quick Inventory of Depressive Symptoms—Self Report (QIDS-SR) 16 Item Scale|rating scale for depressive symptoms based on DSM criteria. A self-report measure for depressive symptoms is valuable in this study, because it is less susceptible to clinician and rater bias. The QIDS-SR has been increasingly used in antidepressant studies (e.g., STAR*D) due to its equivalent weightings for each symptom item, clearly understandable anchor points, and inclusion of all DSM criteria for depression|8 Weeks|Data were not collected||||||
2607948|NCT02082392|Secondary|Blind Assessment—Clinician Version|Rates clinician's guess as to the identity of study medication and the confidence in that guess. This assessment is necessary to document the effectiveness of the study's methods of treatment allocation concealment.|8 weeks|Data were not collected||||||
2607949|NCT02082392|Secondary|California Pharmacotherapy Alliance Scale (CALPAS)—Clinician Version|24 item Likert scale rating the clinician's assessment of the therapeutic alliance, particularly about medication issues, with the patient. This scale is superior to other therapeutic alliance scales because it is focused on drug treatment and does not contain items specific to psychotherapy. Prior studies using the CALPAS reported an association between therapeutic alliance and outcome, and some studies found alliance mediated the effect of expectancy on depression outcome.|Baseline week|Data were not collected||||||
2607950|NCT02082392|Secondary|Treatment Emergent Symptom Scale|rating scale for physical symptoms reported during the study. This is a standard means of recording drug-related adverse effects that will allow us to assess whether contact frequency is associated with differences in side effects among study subjects.|Baseline week|Data were not collected||||||
2607951|NCT02082392|Secondary|CGI Severity and Improvement|"scales developed to measure the clinician's view of subjects' global functioning before and after initiating a study medication. The CGI correlates well with other standard outcome measures for depression (e.g., HRSD), is sensitive to change in antidepressant trials, and offers clinically understandable anchor points.~7-point scale: 0 = Not assessed 4 = Moderately ill~1 = Normal, not at all ill 5 = Markedly ill 2 = Borderline mentally ill 6 = Severely ill 3 = Mildly ill 7 = Among the most extremely ill patients"|Baseline week||||units on a scale||Standard Deviation|Mean
2607952|NCT02082392|Secondary|Hamilton Anxiety Rating Scale (HARS) 14-item Scale|Scale for anxiety symptoms administered by trained rater. The HARS is a standard measure of anxiety severity in pharmacotherapy studies that has been shown to have acceptable reliability and validity in studies of depressed patients. Each item is scored on a scale of 0 (not present) to 4(severe), with a total score range of 0-56, where <17 indi-cates mild severity, 18-24 mild to moderate severity and25-30 moderate to severe.|Baseline week||||units on a scale||Standard Deviation|Mean
2607953|NCT02082392|Primary|Hamilton Rating Scale for Depression|"scale for depressive symptoms administered by trained rater. The HRSD is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. Although the HRSD list 21 items, the scoring is based on the first 17 items.~sum of the scores of the first 17 items (range from 0 to 54): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression >=23 = Very Severe Depression"|Baseline week||||units on a scale||Standard Deviation|Mean
2607954|NCT02082340|Secondary|Quality of Life of TB Patients|Quality of life of TB patients will be measured by surveys|At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)|||||||
2607955|NCT02082340|Secondary|Depression Status of TB Patients|Depression status of TB patients will be measured by surveys|At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)|||||||
2607956|NCT02082340|Secondary|TB Treatment Adherence|TB treatment adherence will be measured by surveys|At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)|||||||
2607957|NCT02082340|Secondary|Family Support Towards TB Patients|Change in family support towards TB patients will be measured by surveys|At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)|||||||
2607958|NCT02082340|Secondary|Stigma Level Towards TB Patients|Stigma level towards TB patients will be measured by surveys|At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)|||||||
2607959|NCT02082340|Secondary|Knowledge About TB Infection|Knowledge about TB infection will be measured by surveys|At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)|||||||
2607960|NCT02082340|Primary|TB Treatment Success Rates Defined by the World Health Organization (WHO)|The sum of cured (TB patients with bacteriologically confirmed TB at the beginning of treatment who were smear- or culture-negative in the last month of treatment and on at least one previous occasion) and treatment completed (TB patients who completed treatment without evidence of failure but with no record to show that sputum smear or culture results in the last month of treatment and on at least one previous occasion were negative,either because tests were not done or because results are unavailable).|Patients were followed for the duration of ambulatory phase of treatment, an average of 4.2 months||||Participants|||Count of Participants
2607961|NCT02082288|Primary|Clinical Pregnancy|A clinical pregnancy will be determined by identifying the presence of a gestational sac at six weeks gestation on transvaginal ultrasonography.|6 weeks||||participants|||Number
2607962|NCT02082262|Primary|Change From Baseline In Ocular Itching Frequency Score Using a 6-point Scale|Ocular itching frequency is assessed on a 6-poing scale, where 0 = did not occur, 1 = once in 3 days, 2 = twice in 3 days, 3 = once every day, 4 = 2 or more times every day, and 5 = virtually all the time over the past 3 days. Ocular itching frequency is evaluated over the 3 days prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Day 70|Modified Intent-to-Treat: all enrolled patients with at least one follow-up ocular itching frequency score|||Scores on a Scale||Standard Deviation|Mean
2607963|NCT02082184|Secondary|Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 194.|"The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (which ranges from -3 (much less satisfied) to +3 (much more satisfied). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).~There is one question to assess the change in perceived frequency of Hypoglycaemia and one question to assess change in perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less of the time now) to +3 (much more of the time now).~The ANCOVA adjusts for baseline DTSQs (status version)."|Baseline and Day 194||||units on a scale||Standard Deviation|Mean
2607964|NCT02082184|Secondary|System Utilisation|Sensor utilisation assessed by percentage of sensor glucose data collected by the intervention group.|Days 15 to 208|138 subjects included in the analysis, 11 were not included due to missing data.|||percentage of sensor glucose collected||Standard Deviation|Mean
2607965|NCT02082184|Secondary|Number of Glucose Measurements Performed|Number of blood glucose fingerstick tests per day by intervention and control group during days 15 to 208. The number of sensor scans performed by the intervention group during days 15 to 208.|Days 15 to 208||||number of measurements per day||Standard Deviation|Mean
2607966|NCT02082184|Secondary|Time Spent >180 mg/dL and >240 mg/dL|Difference in time >180 mg/dL and >240mg/dL (hours per day) between intervention and control group assessed in days 194 to 208 adjusting for baseline (days 1 to 15) using ANCOVA.|Baseline and Days 194 to 208||||hours per day||Standard Deviation|Mean
2610608|NCT02054156|Secondary|Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)|Rate is defined as the number of events per participant follow-up month.|Over the 18-month study period||||events per participant-month|||Number
2607971|NCT02082158|Secondary|To Collect Healthcare Worker Feedback About Perceived Tolerability of Novel Respirator Designs|Subjects will answer questions concerning comfort of respirator utilizing a Likert scale instrument that has been validated to capture comfort and tolerability assessments. This is a single visit study; there is no follow-up. Comfort and tolerability measurements will be compared between new and standard respirator models. The Respirator Comfort, Wearing Experience and Function Instrument (R-COMFI) is made up of 3 subscales: 1) Discomfort subscale (10 items, scored 0 to 2, score range of 0-20), 2) General Wearing Experience subscale (6 items, scored 0 to 2, score range of 0-12), and the 3) Function subscale (5 items, scored 0 to 3, score range of 0-15). An overall comfort and tolerability score is achieved by the sum total of all subscales. The instrument score range is 0-47. Higher scores equate to higher levels of discomfort and inability to tolerate respirator.|Visit 1|Subjects who passed fit-testing, performed study activities and completed survey on the comfort and tolerability of the respirator worn.|||units on a scale||Standard Deviation|Mean
2607972|NCT02082158|Primary|To Collect Healthcare Worker Feedback About Perceived Comfort of Novel Respirator Designs|Subject will participate in set study activities wearing the respirator that he/she was randomized to. Following, Subjects will answer questions concerning comfort of respirator utilizing a Likert scale instrument that has been validated to capture comfort and tolerability assessments. This is a single visit study; there is no follow-up. Comfort and tolerability measurements will be compared between new and standard respirator models. The Respirator Comfort, Wearing Experience and Function Instrument (R-COMFI) is made up of 3 subscales: 1) Discomfort subscale (10 items, scored 0 to 2, score range of 0-20), 2) General Wearing Experience subscale (6 items, scored 0 to 2, score range of 0-12), and the 3) Function subscale (5 items, scored 0 to 3, score range of 0-15). An overall comfort and tolerability score is achieved by the sum total of all subscales. The instrument score range is 0-47. Higher scores equate to higher levels of discomfort and inability to tolerate respirator.|Visit 1|Subjects who passed fit-testing, performed study activities and completed survey on the comfort and tolerability of the respirator worn.|||units on a scale||Standard Deviation|Mean
2607973|NCT02082145|Secondary|PAID - Quality of Life Questionnaires|PAID is a self-administered 20-item scale. Each item is scored from 0 (not a problem) to 4 (serious problem). The sum of all item scores multiplied by 1.25 gives the total PAID score, which ranges from 0 to 100, higher scores reflecting greater emotional distress.|Baseline, 10 weeks||||score on a scale||Standard Deviation|Mean
2607974|NCT02082145|Primary|Nerve Conduction Speed (Common Peroneal Nerve)||Baseline, 10 weeks||||m/sec||Standard Deviation|Mean
2607975|NCT02081963|Secondary|Forced Expiratory Volume in One Second (FEV1) After 14 Days of Treatment||after 14 days||||L||Standard Deviation|Mean
2607976|NCT02081963|Secondary|Forced Expiratory Volume in One Second (FEV1) (Percent of Predicted for Age) After 14 Days of Treatment||after 14 days||||Percent of Predicted||Standard Deviation|Mean
2607977|NCT02081963|Secondary|Sputum Property Score After 14 Days of Treatment|The sputum properties were graded from 1 to 4, with 1 being assigned to transparent mucous sputum, 2 to yellow purulent sputum, 3 to green purulent sputum, and 4 to black green purulent sputum. Higher scores mean a worse outcome.|after 14 days||||score on a scale||Standard Deviation|Mean
2607978|NCT02081963|Secondary|Total Sputum Weight (Collected Over 24 h) After 14 Days of Treatment||after 14 days||||g||Standard Deviation|Mean
2607979|NCT02081963|Primary|Bacterial Clearance Rate of Sputum|The bacterial eradication rate of the sputum was calculated by the number of P. aeruginosa-eradicated cases according to sputum culture testing result. Sputum samples were collected in the morning after toothbrushing and gargling, before the patients used any medicine. Eligible sputum samples were defined as having ≥25 white blood cells/highpower field and ≤10 epithelial cells/high-power field; the samples were sent for testing within 60 min. Sputum samples were collected again after 14 days. If the second sputum culture test showed a negative result after the first one had been positive, it was defined as eradicated.|after 14 days||||Participants|||Count of Participants
2607980|NCT02081859|Secondary|Implantation Rate|Percent of embryos implanted assessed at time of ultrasound|6 weeks||||Percentage of embryos|||Number
2607981|NCT02081859|Primary|Clinical Pregnancy Rate|Patients will have a ultrasound to document fetal heart rate approximately 6 weeks after start of IVF cycle.|6 weeks||||Participants|||Count of Participants
2607982|NCT02081846|Secondary|Number of Participants With Occurrence(s) of 14-day Unplanned Healthcare Utilization|Occurrence(s) of 14-day unplanned healthcare utilization defined by unplanned re-hospitalization and/or any emergency/urgent care visit within 14 days or parent report of an unplanned visit to one of these places. Parent report is collected at the 14 day follow-up phone call.|14 days post-discharge|The analysis population includes the total 1,500 (751 intervention, 749 control) randomized excluding the two subjects withdrawn in the intervention group after randomization (1 due to invalid consent, 1 requested withdrawal).|||Participants|||Count of Participants
2607983|NCT02081846|Secondary|Number of Participants With Occurrence(s) of an Emergency Department Visit Within 30 Days Post-discharge|Occurrence(s) of an ED visit within 30 days post-discharge|30 days|The analysis population includes the total 1,500 (751 intervention, 749 control) randomized excluding the two subjects withdrawn in the intervention group after randomization (1 due to invalid consent, 1 requested withdrawal).|||Participants|||Count of Participants
2607984|NCT02081846|Secondary|Number of Participants With Occurrence(s) of an Unplanned Readmission Within 30 Days Post-discharge|Occurrence(s) of an unplanned readmission within 30 days post-discharge.|30 days|The analysis population includes the total 1,500 (751 intervention, 749 control) randomized excluding the two subjects withdrawn in the intervention group after randomization (1 due to invalid consent, 1 requested withdrawal).|||Participants|||Count of Participants
2608012|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Variable Vision)|The Ocular symptom Variable Vision was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
2610105|NCT02058940|Secondary|Glycemic Variability|Glycemic variability is defined as the standard deviation of glucose calculated from hourly glucose measurements starting at infusion initiation over 48 hours|Over 48 hours from infusion initiation||||mg/dL||Inter-Quartile Range|Median
2607985|NCT02081846|Secondary|Red Flags Remembered|"This was measured at the 14 day post-discharge phone call survey. Parents were asked to recall any red flags or warning signs to indicate the child's condition was getting worse. The number of red flags recalled could range from 0-10 depending on the template used. The template was a home visit guideline for nurses to use that was specific to the child's illness. For example, if the child had bronchiolitis the nurse would use the template bronchiolitis/croup/pneumonia to guide them through the visit. Higher values (i.e., the greater number of red flags remembered) represent a better outcome."|14 days post-discharge|The analysis population includes the total subjects completing the 14-day phone call survey. Of the total randomized (1,500: 751 intervention, 749 control), 29 were excluded from the intervention group and 26 from the control group for not completing the 14-day phone call survey.|||units on a scale||95% Confidence Interval|Least Squares Mean
2607986|NCT02081846|Secondary|Days Until Normalcy|"Number of days until normalcy: measured at post discharge phone call. Parents asked to recall the number of days it took to return to a 'normal' routine including the return to work and school (with option of not yet be back to normal)."|14 days post-discharge|The analysis population includes the total subjects completing the 14-day phone call survey with a response for the return to normalcy question. Of the total randomized (1,500: 751 intervention, 749 control), 30 were excluded from the intervention group and 26 from the control group with no data available for this outcome.|||days||95% Confidence Interval|Least Squares Mean
2607987|NCT02081846|Secondary|Post Discharge Coping Difficulty Scale|Post-Discharge Difficulty Coping Scale (Weiss, et. al) measured at 14 day post-discharge phone call. Post-Discharge Coping Difficulty Scale uses an 11 point scaling format (0-10) with total scores ranging from 0 to 100. Higher scores represent greater coping difficulty.|14 days post-discharge|The analysis population includes the total subjects completing the 14-day phone call survey. Of the total randomized (1,500: 751 intervention, 749 control), 29 were excluded from the intervention group and 26 from the control group.|||units on a scale||95% Confidence Interval|Least Squares Mean
2607988|NCT02081846|Primary|Number of Participants With Any Occurrence of Unplanned Re-hospitalization and/or Any Emergency/Urgent Care Visits Within 30 Days of Hospital Discharge|The dependent variable will be a dichotomized indicator of any occurrence of unplanned rehospitalization and/or any emergency department/urgent care visit within 30-days post-discharge (i.e. unplanned reutilization). Differences in this outcome between intervention and control groups will be evaluated using logistic regression with the stratification variables (neighborhood poverty and complex versus noncomplex teams) included in the model.|30 days post-discharge|The analysis population includes the total 1,500 (751 intervention, 749 control) randomized excluding the two subjects withdrawn in the intervention group after randomization (1 due to invalid consent, 1 requested withdrawal).|||Participants|||Count of Participants
2607989|NCT02081807|Secondary|Pulmonary Embolism (PE)|The rate of Pulmonary Embolism (PE) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: ICD-9 415.1x (pulmonary embolism and infarction)|From October 2010 to September 2015 (the study period)|Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.|||Incidence rate per 100 person-years||95% Confidence Interval|Number
2607990|NCT02081807|Secondary|Deep Vein Thrombosis (DVT)|The rate of DVT in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: Validated algorithm: ICD-9 451.1x, ICD-9 451.2x,ICD-9 451.81, ICD-9 451.9x, ICD-9 453.1x, ICD-9 453.2x, ICD-9 453.8x, ICD-9 453.9x ; Not in the validated algorithm but will be included following Mini-Sentinel recommendation for VTE outcome: ICD-9 453.40 (Venous embolism and thrombosis of unspecified deep vessels of lower extremity (includes DVT), ICD-9 453.41 (Venous embolism and thrombosis of deep vessels of proximal lower extremity (includes femoral, iliac, popliteal, thigh, and upper leg), ICD-9 453.42 (Venous embolism and thrombosis of deep vessels of distal lower extremity (includes calf, lower leg, peroneal, and tibia), ICD-9 453.0 (Hepatic vein thrombosis)|From October 2010 to September 2015 (the study period)|Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.|||Incidence rate per 100 person-years||95% Confidence Interval|Number
2607991|NCT02081807|Secondary|Venous Thromboembolism (VTE)|The rate of Venous Thromboembolism (VTE) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. For outcome definitions please refer the descriptions section of outcome 18 (Deep vein thrombosis (DVT)) and outcome 19 (Pulmonary Embolism (PE)).|From October 2010 to September 2015 (the study period)|Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.|||Incidence rate per 100 person-years||95% Confidence Interval|Number
2608013|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Redness)|The Ocular symptom Redness wasassessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
2608096|NCT02081079|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
2607992|NCT02081807|Secondary|Myocardial Infarction (MI)|The rate of Myocardial infarction (MI) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: ICD-9 Dx 410.X (acute myocardial infarction) excluding 410.x2 (subsequent episode of care), as the principal (primary) or the next (secondary) diagnosis AND a length of stay (LOS) between 3-180 days, or death if LOS is < 3 days|From October 2010 to September 2015 (the study period)|Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.|||Incidence rate per 100 person-years||95% Confidence Interval|Number
2607993|NCT02081807|Secondary|Transient Ischemic Attack (TIA)|The rate of Transient Ischemic Attack (TIA) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: ICD-9 Dx code 435.xx (transient cerebral ischemia) as the principal (primary) discharge diagnosis|From October 2010 to September 2015 (the study period)|Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.|||Incidence rate per 100 person-years||95% Confidence Interval|Number
2607994|NCT02081807|Secondary|Other Major Bleeding|The rate of Other major bleeding in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: Other major bleeds: Hemathrosis: 719.1x, Hemopericardium: 423.0x, Hemoptysis: 786.3x, Epistaxis: 784.7x, Hemorrhage not specified 459.0x, Acute posthemorrhagic anemia 285.1x|From October 2010 to September 2015 (the study period)|Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.|||Incidence rate per 100 person-years||95% Confidence Interval|Number
2607995|NCT02081807|Secondary|Major Urogenital Bleeding|The rate of major urogenital bleeding in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: ICD-9 diagnoses: Hematuria: ICD-9 Dx: 599.7, Excessive/frequent menstruation: ICD-9 Dx 626.2x and secondary diagnosis indicating acute bleeding: anemia (280.0, 285.1, 285.9). Across databases, only one event for dabigatran versus no event among warfarin initiators observed. Across database, four events for rivaroxaban versus no event among warfarin initiators observed. Across database, no events for apixaban and warfarin observed. Therefore HR estimate is not possible.|From October 2010 to September 2015 (the study period)|Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.|||Incidence rate per 100 person-years||95% Confidence Interval|Number
2607996|NCT02081807|Secondary|Major Lower Gastrointestinal Bleeding|The rate of lower gastrointestinal bleeding in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: Lower GI/unspecified GI site bleeds :Diverticulosis of small intestine with hemorrhage: 562.02, Diverticulitis of small intestine with hemorrhage: 562.03, Diverticulosis of colon with hemorrhage: 562.12, Diverticulitis of colon with hemorrhage: 562.13, Hemorrhage of rectum and anus: 569.3x, Angiodysplasia of intestine with hemorrhage: 569.85, Blood in stool: 578.1x, Hemorrhage of GI tract, unspecified: 578.9|From October 2010 to September 2015 (the study period)|Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.|||Incidence rate per 100 person-years||95% Confidence Interval|Number
2607997|NCT02081807|Secondary|Major Upper Gastrointestinal Bleeding|The rate of Major upper gastrointestinal bleeding in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: ICD-9 diagnoses: 531.0x, 531.2x, 531.4x, 531.6x, 532.0x, 532.2x, 532.4x, 532.6x, 533.0x, 533.2x, 533.4x, 533.6x, 534.0x, 534.2x, 534.4x, 534.6x, 578.0 OR ICD-9 procedure code 44.43 (endoscopic control of gastric or duodenal bleeding) OR Current Procedural Terminology (CPT) code 43255 (upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method).|From October 2010 to September 2015 (the study period)|Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.|||Incidence rate per 100 person-years||95% Confidence Interval|Number
2608014|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Lens Awareness)|The Ocular symptom Lens awareness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
2607998|NCT02081807|Secondary|Major Gastrointestinal (GI) Bleeding|The rate of major gastrointestinal (GI) bleeding (Major upper GI bleeding, major lower/unspecified GI bleeding) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. For outcome definitions please refer the descriptions section of outcome 11 (Major upper gastrointestinal bleeding) and outcome 12 (Major lower gastrointestinal bleeding).|From October 2010 to September 2015 (the study period)|Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.|||Incidence rate per 100 person-years||95% Confidence Interval|Number
2607999|NCT02081807|Secondary|Major Extra-cranial Bleeding|The rate of major extracranial bleeding (Major upper GI bleed, major lower and unspecified GI bleed, major urogenital bleed, major other bleed) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. For outcome definitions please refer the descriptions section of outcome 11 (Major upper gastrointestinal bleeding), outcome 12 (Major lower gastrointestinal bleeding), outcome 13 (Major urogenital bleeding) and outcome 14 (Other major bleeding).|From October 2010 to September 2015 (the study period)|Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.|||Incidence rate per 100 person-years||95% Confidence Interval|Number
2608000|NCT02081807|Secondary|Major Intracranial Bleeding|The rate of major intracranial bleeding in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: ICD-9 diagnosis: 430.x Subarachnoid hemorrhage (SAH), 431.x Intracerebral hemorrhage (ICH), 432.x other and unspecified intracranial hemorrhage including 432.1x - subdural hemorrhage|From October 2010 to September 2015 (the study period)|Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.|||Incidence rate per 100 person-years||95% Confidence Interval|Number
2608001|NCT02081807|Secondary|Stroke Uncertain Classification|The rate of stroke uncertain classification in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): ICD-9 Dx code 436.x (acute, but ill-defined cerebrovascular disease).|From October 2010 to September 2015 (the study period)|Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.|||Incidence rate per 100 person-years||95% Confidence Interval|Number
2608002|NCT02081807|Secondary|Hemorrhagic Stroke|The rate of hemorrhagic in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): 431.x Intracerebral hemorrhage (ICH)|From October 2010 to September 2015 (the study period)|Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.|||Incidence rate per 100 person-years||95% Confidence Interval|Number
2608003|NCT02081807|Secondary|Ischemic Stroke|The rate of ischemic stroke in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: As primary ICD-9 discharge diagnosis (Dx): 433.x1 Occlusion and stenosis of precerebral arteries with cerebral infarction, ICD-9 Dx 434.x1 Occlusion and stenosis of cerebral arteries with cerebral infarction|From October 2010 to September 2015 (the study period)|Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.|||Incidence rate per 100 person-years||95% Confidence Interval|Number
2608004|NCT02081807|Secondary|Systemic Embolism|The rate of systemic embolism in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: ICD-9 Diagnoses: 444.x Arterial embolism.|From October 2010 to September 2015 (the study period)|Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.|||Incidence rate per 100 person-years||95% Confidence Interval|Number
2608097|NCT02081079|Primary|Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants were enrolled and received at least 1 dose of study drug|||percentage of participants|||Number
2610106|NCT02058940|Secondary|Median Time to Reach Glucose Measurements Within Goal Range (110-180 mg/dL)|Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours|Over 48 hours from infusion initiation||||minutes||Inter-Quartile Range|Median
2608005|NCT02081807|Secondary|Stroke or Systemic Embolism|The rate of stroke (hemorrhagic, ischemic or stroke of uncertain classification ) or systemic embolism in patients matched on propensity scores and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. For outcome definitions please refer the descriptions section of outcome 4 (Systemic embolism), outcome 5 (Ischemic stroke), outcome 6 (Hemorrhagic stroke) and outcome 7 (Stroke uncertain classification).|From October 2010 to September 2015 (the study period)|Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.|||Incidence rate per 100 person-years||95% Confidence Interval|Number
2608006|NCT02081807|Primary|Major Bleeding|The rate of major bleeding (Major intracranial bleeding and major extracranial bleed ) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. For outcome definitions please refer the descriptions section of outcome 8 (major intracranial bleeding) and outcome 9 (major extracranial bleeding).|From October 2010 to September 2015 (the study period)|Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.|||Incidence rate per 100 person-years||95% Confidence Interval|Number
2608007|NCT02081807|Primary|Stroke (Hemorrhagic, Ischemic, or Stroke of Uncertain Classification)|The rate of overall stroke (hemorrhagic, ischemic or stroke of uncertain classification ) in patients who are matched on propensity score and calendar quarter of initiation. Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort. The outcome definition includes following: As primary International Classification of Diseases, Ninth Revision (ICD-9) discharge diagnosis (Dx): 431.x Intracerebral hemorrhage (ICH), 433.x1 Occlusion and stenosis of precerebral arteries with cerebral infarction, 434.x1 Occlusion and stenosis of cerebral arteries with cerebral infarction, 436.x Acute, but ill-defined cerebrovascular events.|From October 2010 to September 2015 (the study period)|Patients with non-valvular atrial fibrillation (NVAF) and new initiators of dabigatran and warfarin during October 2010 to September 2015 who were enrolled for a minimum of 12 months in Optum Clinformatics database or MarketScan before treatment initiation and matched on propensity scores (PS). Primary analysis represented an 'as treated' approach.|||Incidence rate per 100 person-years||95% Confidence Interval|Number
2608008|NCT02081690|Primary|Evaluation of the Reliability and the Construct Validity of the Cognitive/Emotional Impacts Domain of the PAH-SYMPACT|"The Cognitive/Emotional Impacts domain consists of 4 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to not at all/with no difficulty at all and value 4 corresponds to very much/extremely/ not able at all. The impacts part of the PAH-SYMACT was administered on Day 7 of the symptoms part administration. Items in the impact part have a 7 day recall period. An average Cognitive/Emotional Impacts domain score is determined based on the 4 items in the domain. It was administered two times prior to administration of Macitentan (Visit 2, Baseline) and during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16)."|From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16)|Validation set|||Score on a scale||Standard Deviation|Mean
2608009|NCT02081690|Primary|Evaluation of the Reliability and the Construct Validity of the Physical Impacts Domain of the PAH-SYMPACT|"The Physical Impacts domain consists of 7 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to not at all/with no difficulty at all and value 4 corresponds to very much/extremely/ not able at all. The impacts part of the PAH-SYMACT was administered on Day 7 of the symptoms part administration. Items in the impact part have a 7 day recall period. An average Physical Impacts domain score is determined based on the 7 items in the domain. It was administered two times prior to administration of Macitentan (Visit 2, Baseline) and during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16)."|From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16)|Validation set|||Score on a scale||Standard Deviation|Mean
2608010|NCT02081690|Primary|Evaluation of the Reliability and the Construct Validity of the Cardiovascular Symptoms Domain of the PAH-SYMPACT|"The Cardiovascular Symptoms domain consists of 5 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to no symptoms and value 4 corresponds to very severe symptoms. The symptoms part of the PAH-SYMPACT was administered daily over a 7 day period. The recall period of symptom items is the last 24 hours. An average Cardiovascular Symptoms domain score is determined based on the daily scores of the 5 items. It was administered two times (daily during 7 days each time) prior to administration of Macitentan (Visit 2, Baseline) and daily during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16)."|From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16)|Validation set|||Score on a scale||Standard Deviation|Median
2608011|NCT02081690|Primary|Evaluation of the Reliability and the Construct Validity of the Cardiopulmonary Symptoms Domain of the PAH-SYMPACT|"The Cardiopulmonary Symptoms domain consists of 6 items reported on a 5-point Likert scale (from 0 to 4). The value 0 means no symptom and value 4 corresponds to very severe symptoms.The symptoms part of the PAH-SYMPACT was administered daily over a 7 day period. The recall period of symptom items is the last 24 hours. An average Cardiopulmonary Symptoms domain score is determined based on the daily scores of the 6 items. It was administered two times (daily during 7 days each time) prior to administration of Macitentan (Visit 2, Baseline) and daily during the 7-day period in the treatment period prior to Visit 3 (Week 8) and Visit 4 (Week 16)."|From Screening Visit (Visit 1) to End of Treatment (EOT) Visit (Visit 4, Week 16)|Validation set|||Score on a scale||Standard Deviation|Mean
2608098|NCT02081079|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 4 or 5 HCV infection who were enrolled and received at least on dose of study drug.|||percentage of participants|||Number
2608015|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness)|The Ocular symptom Itchiness/Scratchiness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
2608016|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Irritation/Discomfort)|The Ocular symptom Irritation/Discomfort was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
2608017|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation)|The Ocular symptom Grittiness/Foreign Body Sensation was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
2608018|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Dryness)|The Ocular symptom Dryness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
2608019|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy)|The Ocular symptom Cloudy/Blurry/Hazy was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
2608020|NCT02081677|Primary|Tarsal Abnormalities|Tarsal abnormalities were assessed using a biomicroscope at baseline, post lens fitting, 1-, 2- and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0, 1, 2, 3 and 4) with grade 0 represents the absence of abnormalities and 1 to 4 representing successively worse abnormalities (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The percentage of eyes with Grade 3 or higher was reported.|1-, 2- and 4-Week Follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Subject Eyes||Number
2608021|NCT02081677|Primary|Corneal Staining|Corneal Staining was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.|Baseline and 4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Subject Eyes||Number
2608022|NCT02081677|Primary|Corneal Neovascularization|Corneal Neovascularization was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.|Baseline and 4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Subject Eyes||Number
2608023|NCT02081677|Primary|Conjunctival Injection|Conjunctival Injection was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.|Baseline and 4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Subject Eyes||Number
2608024|NCT02081677|Primary|Corneal Edema|Corneal Edema was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.|Baseline and 4-Week Follow-up|All subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Subject Eyes||Number
2608025|NCT02081677|Primary|Percentage of Reported Ocular Symptoms (Burning/Stinging)|The Ocular symptom Burning/Stinging was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.|Baseline and 4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
2608026|NCT02081677|Primary|Lens Fitting Characteristics|Lens fit was assessed for each subject eye at post lens fitting and 4- week follow-up evaluations. Lens fit is a binary response as acceptable or unacceptable lens fit. The percentage of eyes with acceptable lens fit was reported.|Post Lens Fitting and 4-Week Follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation.|||Percentage of Eyes|Eyes||Number
2608027|NCT02081677|Primary|Visual Acuity (LogMAR)|Visual Acuity (LogMAR) was assessed bionocularly at the 4-week follow-up evaluations. The average visual acuity (LogMAR) for each lens was reported.|4-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||LogMAR|Eyes|Standard Deviation|Mean
2608028|NCT02081677|Primary|Bulbar Conjunctival Redness|Bulbar Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Bulbar Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for bulbar redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point.|Baseline and 2-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||units on a scale|Subject Eye|Standard Deviation|Mean
2608029|NCT02081677|Primary|Limbal Conjunctival Redness|Limbal Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Limbal Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for limbal redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point.|Baseline and 2-Week Follow-up|Subjects that completed all study visits without a major protocol deviation.|||units on a scale|Subject Eye|Standard Deviation|Mean
2608030|NCT02081677|Primary|Corneal Staining (Type)|Corneal Staining was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 =Micropunctate, Grade 2 = Macropunctate, Grade 3 = Coalesced Macropunctate and Grade 4 = Patch (greater or equal to 1mm). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.|Baseline and 4-Week Follow-up|The analysis population consist of all subjects that completed all study visits without a major protocol.|||Units on a scale|Subject Eyes|Standard Deviation|Mean
2608031|NCT02081677|Primary|Corneal Staining (Depth)|Corneal Staining Depth was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 4-point scale (i.e. Grade 0= None, Grade 1 =Superficial epithelial, Grade 2 = Full epithelial, Grade 3 =stromal glow). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.|Baseline and 4-Week Follow-up|The analysis population consist of all subjects that completed all study visits without a major protocol.|||Units on a scale|Subject Eyes|Standard Deviation|Mean
2608032|NCT02081677|Primary|Corneal Staining (Area)|Corneal Staining Area was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 11-point scale (i.e. Grade 0= 0% of region covered, Grade 1 =10% of region covered, Grade 2 = 20% of region covered, Grade 3 = 30% of region covered, Grade 4= 40% of region covered, Grade 5 = 50% of region covered, Grade 6 = 60% of region covered,Grade 7 = 70% of region covered, Grade 8 = 80% of region covered, Grade 9 = 90% of region covered and Grade 10 = 100% of region covered). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.|Baseline and 4-Week Follow-up|The analysis population consist of all subjects that completed all study visits without a major protocol.|||Units on a scale|Subject Eyes|Standard Deviation|Mean
2608033|NCT02081599|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose|The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.|at Week 0 and Week 16|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg/dL||Standard Error|Least Squares Mean
2608034|NCT02081599|Secondary|Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose|The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate.|0, 0.5, 1, 2 hours post-dose at Week 0 and Week 16|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization.|||mg*hr/dL||Standard Error|Least Squares Mean
2608035|NCT02081599|Secondary|Change From Baseline in Fasting Plasma Glucose|The change from Baseline in Fasting Plasma Glucose collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.|at Week 0 and Week 16|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last post baseline double-blind observed value was carried forward and used for Week 16 where data was missing.|||mg/dL||Standard Error|Least Squares Mean
2608036|NCT02081599|Primary|Change From Baseline in HbA1c|The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.|at Week 0 and Week 16|The full analysis set, consisting of all type 2 diabetic patients, who received at least one dose of study drug and who had at least one efficacy data after randomization. Analysis based on last observation carried forward, where the last post baseline double-blind observed value was carried forward and used for Week 16 where data was missing.|||percentage of HbA1c||Standard Error|Least Squares Mean
2608037|NCT02081586|Secondary|Body Mass Index Change|Change in Body Mass Index from baseline to post intervention|baseline to 16 weeks|Of 13 initially randomized, there were 2 dropouts and one was withdrawn from the study.|||kg/m^2||Full Range|Mean
2608038|NCT02081586|Secondary|Diabetes Distress Scale- Change Score|Levels of diabetes distress per standardized questionnaire will be measured before intervention and after intervention. Percent change of mean score between baseline and 16 weeks is reported. Adapted from Fisher, L., Glasgow, R.E., Mullan, J.T., Skaff, M.M., Polonsky, W.H. (2008) Development of a Brief Diabetes Screening Instrument. Annals of Family Medicine; 6:246-252.|baseline to 16 weeks|Of thirteen initially randomized, one was withdrawn prior to treatment, one is missing data, and two dropped out. Therefore we do not have change scores for these pariticipants.|||percent change||Full Range|Mean
2608039|NCT02081586|Secondary|MEMS (Medication Electronic Monitoring System) Cap Electronic Pill Bottle Adherence|Electronically measured medication adherence, percent adherence over entire study phase. Change score was not evaluated, this measure is to determine feasability of use over time. Percent adherence is measured by the number of correct doses per day divided by the number of prescribed doses per day X 100. Percent adherence was calculated as the percentage of the prescribed doses of the medication actually taken by the patient over 16 weeks|16 weeks||||percent adherent||Full Range|Mean
2608040|NCT02081586|Primary|Computer System Usability Questionnaire (CSUQ)|"The CSUQ measures feasibility and acceptability of the phone application. Adapted from Lewis JR.: IBM Computer Usability Satisfaction Questionnaires: Psychometric Evaluation and Instructions for Use. International Journal of Human-Computer Interaction 1995; 7 (1):67-78.~Scale is scored as a mean value, range is from 1 to 7. In this adaptation lower scores are better usability."|16 weeks|As per protocol, usability was analyzed for participants administered phone CBT, regardless of duration. Six subjects completed the CSUQ. Of ten initially assigned treatment, one was withdrawn prior to treatment, one missed the CSUQ, and two dropped out. Treatment as usual Arm did not use the phone.|||units on a scale (1-7)||Standard Deviation|Mean
2608041|NCT02081586|Primary|HbA1c Level Change Scores From Baseline to 16 Weeks|Change from baseline HbA1c level to post intervention|baseline to 16 weeks|per protocol|||percent||Standard Deviation|Mean
2608042|NCT02081573|Secondary|Body Mass Index|Change in Body Mass Index from before to after treatment|12 weeks|Change BMI over time.|||kg/m^2||Standard Deviation|Mean
2608043|NCT02081573|Secondary|HbA1c Level|Change in HbA1c from before to after treatment|12 weeks||||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2608044|NCT02081573|Secondary|Medication Beliefs Scale|Change in medication beliefs from before and after intervention. Adapted from Horne, R., Weinman, J., Hankins, M. (1999). The Beliefs About Medicines Questionnaire: The Development and Evaluation of a New Method for Assessing the Cognitive Representation of Medications. Psychology and Health 14: 1-24.|12 weeks|||||||
2608045|NCT02081573|Secondary|Diabetes Distress Scale|Levels of diabetes distress per standardized questionnaire will be measured before intervention and after intervention. Change of mean score is reported. Change in score from baseline to post followup. Lower score means less distress. Scale range is from 1-6. Adapted from Fisher, L., Glasgow, R.E., Mullan, J.T., Skaff, M.M., Polonsky, W.H. (2008) Development of a Brief Diabetes Screening Instrument. Annals of Family Medicine; 6:246-252.|12 weeks|Change in score from baseline to post followup|||mean of scale items||Standard Deviation|Mean
2608046|NCT02081573|Secondary|Morisky Questionnaire|Brief scale of adherence to medications. Morisky 5 items was used. Mean score presented. Scale range is from 5-13. Lower score is better adherence. Mean change from baseline to 12 weeks is examined.|12 weeks|Mean change from baseline to 12 weeks.|||mean of scale items||Standard Deviation|Mean
2608047|NCT02081573|Primary|Acceptability Questionnaire.|The acceptability questionnaire measures feasibility and acceptability of the Brief CBT protocol. Adapted from Lewis JR.: IBM Computer Usability Satisfaction Questionnaires: Psychometric Evaluation and Instructions for Use. International Journal of Human-Computer Interaction 1995; 7 (1):67-78. Scale is scored as a mean and ranges from 1-7. In this adaptation, lower scores are better satisfaction.|12 weeks|Mean acceptability of the Brief CBT protocol.|||mean of scale items||Standard Deviation|Mean
2608048|NCT02081456|Secondary|Patient Specific Functional Scale|Perceived ability to perform specific activities on a scale of 0 to 30, where 0 indicates complete inability to perform and 30 indicates able to perform activity at the same level as before injury or problem. Therefore higher scores are better. Outcome results are given and mean changes from pre to post interventions, therefore, a positive value indicates improvement.|at 2-4 day follow up||||units on a scale||95% Confidence Interval|Mean
2608049|NCT02081456|Secondary|Neck Disability Index|Measure of perceived disability on a scale of 0 to 50, where 0 indicates no disability and 50 indicates maximum disability. Therefore, lower scores are better. Outcome results are given and mean changes from pre to post interventions, therefore, a negative value indicates improvement.|2-4 day follow up||||units on a scale||95% Confidence Interval|Mean
2608050|NCT02081456|Primary|Numeric Pain Rating Scale|Measures perceived level of pain on a scale from 0 to 10, where 0 indicates 'no pain' and 10 indicates 'worst imaginable pain'. Therefore, lower scores are better. Outcome results are given and mean changes from pre to post interventions, therefore, a negative value indicates improvement.|up to 2-4 day follow up||||units on a scale||95% Confidence Interval|Mean
2608051|NCT02081456|Primary|Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion||up to 2-4 day follow up||||degrees||95% Confidence Interval|Mean
2608052|NCT02081443|Secondary|PRI Measured by VASP|PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment|4 hours||||%PRI||Standard Error|Mean
2608053|NCT02081443|Secondary|PRI Measured by VASP|PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment|1 hour||||%PRI||Standard Error|Mean
2608054|NCT02081443|Primary|Platelet Reactivity Index (PRI) Determined by Whole Blood Vasodilator-stimulated Phosphoprotein (VASP)|PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment|Baseline||||%PRI||Standard Error|Mean
2608055|NCT02081417|Other Pre-specified|Change in Overall Physical Health|Overall mental health and physical health will be assessed by the subscales of the SF-36 (short form 36). The SF-36 questions measure functional health and well-being from the patient's point of view. It is a practical, reliable, and valid measure of mental and physical health that can be completed in five to 10 minutes. The Component Summary Scores range from 0% to 100% with higher scores indicative of higher functioning|baseline, 3-Month||||Score on a Scale||95% Confidence Interval|Least Squares Mean
2608056|NCT02081417|Other Pre-specified|Change in Overall Mental Health|Overall mental health and physical health will be assessed by the subscales of the SF-36 (short form 36). The SF-36 questions measure functional health and well-being from the patient's point of view. It is a practical, reliable, and valid measure of mental and physical health that can be completed in five to 10 minutes. The SF-36 has proven useful in differentiating the health benefits produced by different treatments. The Component Summary Scores range from 0% to 100% with higher scores indicative of higher functioning|baseline, 3 months||||Score on a Scale||95% Confidence Interval|Least Squares Mean
2608057|NCT02081417|Secondary|Change in Substance Use - Drug Use|Drug and alcohol problem severity will be assessed using the drug and alcohol subscales of the Addiction Severity Index (ASI). Items assess frequency of drug and alcohol use and abuse within the past 30 days, how bothered the individual is by his/her drug or alcohol problems, and the importance of treatment. Higher composite scores indicate more severe problems. The ASI questions focus on two distinct time periods: the past 30 days and lifetime. A number of studies have confirmed the reliability and validity of the ASI.|Baseline, 3-Month|Frequency of participants greater than or equal to median ASI Drug Composite Score 0.1077|||participants|||Number
2608058|NCT02081417|Secondary|Change in Substance Use - Alcohol Use|Drug and alcohol problem severity will be assessed using the drug and alcohol subscales of the Addiction Severity Index (ASI). Items assess frequency of drug and alcohol use and abuse within the past 30 days, how bothered the individual is by his/her drug or alcohol problems, and the importance of treatment. Higher composite scores indicate more severe problems. The ASI questions focus on two distinct time periods: the past 30 days and lifetime. A number of studies have confirmed the reliability and validity of the ASI.|baseline, 3 months|Number of Participants with an Addiction Severity Index Alcohol Composite Score greater than or equal to median of 0.0111.|||participants|||Number
2608059|NCT02081417|Primary|Change in Coping Skills|The Coping Scale will be used to assess coping skills. The Coping Scale directly assesses the degree to which participants report using 17 specific coping skills from SS, scaled from 0 (not at all) to 5 (extremely). This scale was selected as it is the most widely used measure of coping in the SS literature. As a result we will be able to directly compare our findings to other studies. Higher scores indicate greater frequency of use of coping skills with the range of total scores being 0 to 90|baseline, 3 months||||Score on a Scale||95% Confidence Interval|Least Squares Mean
2608060|NCT02081417|Primary|Change in Post-traumatic Stress Disorder Symptoms|PTSD Symptoms will be measured by the post-traumatic symptom checklist - civilian version. Responses are summed to yield a total severity score, with the full range for total scores being 17 to 85 (higher scores mean higher severity).|baseline, 3 months||||Score on a Scale||95% Confidence Interval|Least Squares Mean
2608061|NCT02081391|Other Pre-specified|Median Amount of Supplemental Opioid Analgesic Medication Use After First Intake of Investigational Medicinal Product in Children Aged From Birth to Less Than 2 Years|The median amount of supplemental opioid analgesic medication (SOAM) used in the Full Analysis Set subset aged from birth to less than 2 years old was determined from 0 to 12 hours and from 0 to 24 hours after first intake of IMP. SOAM use is expressed in mg/kg of morphine i.v. equivalents.|Up to 24 hours|Full Analysis Set: subset of 15 participants from birth to less than 2 years included in the analysis; participants with missing data were excluded from calculations. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.|||mg/kg||Full Range|Median
2608062|NCT02081391|Other Pre-specified|Mean Amount of Supplemental Opioid Analgesic Medication Use After First Intake of Investigational Medicinal Product in Children Aged From Birth to Less Than 2 Years|The mean amount of supplemental opioid analgesic medication (SOAM) used in the Full Analysis Set subset aged from birth to less than 2 years old was determined from 0 to 12 hours and from 0 to 24 hours after first intake of IMP. SOAM use is expressed in mg/kg of morphine i.v. equivalents.|Up to 24 hours|Full Analysis Set: subset of 15 participants from birth to less than 2 years included in the analysis; participants with missing data were excluded from calculations. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.|||mg/kg||Full Range|Mean
2608063|NCT02081391|Secondary|Acceptability of IMP After Last Dose Assessed Using Facial 5-point Hedonic Scale|"Acceptability of IMP in participants aged 2 years to less than 18 years was assessed using 5-point hedonic scales in combination with verbal rating. A question Swallowing the medication is... was asked and the verbal rating was from really good, good, a bit good/a bit bad, bad, and really bad. The pictorial scale of facial expressions was co-related with verbal rating range, with 5 = really easy, 4 = easy, 3 = a bit easy/a bit difficult, 2 = difficult, and 1 = really difficult. Higher scores represent better acceptability.~Responses were summarized. Missing values were not imputed. Acceptability data was not collected in participants <2 years old."|Up to 96 hours|Full Analysis Set; 160 participants aged 2 to less than 18 years were included in the analysis. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.|||Participants|||Count of Participants
2608064|NCT02081391|Secondary|Palatability of IMP After Last Dose Assessed Using Facial 5-point Hedonic Scale|"Palatability of IMP after the last dose in participants aged 2 years to less than 18 years was assessed using 5-point hedonic scales in combination with verbal rating. A question How does the medication taste was asked and the verbal rating was from really good, good, a bit good/a bit bad, bad, and really bad. The pictorial scale of facial expressions was co-related with verbal rating range with 5 = really good, 4 = good, 3 = a bit good/a bit bad, 2 = bad, and 1 = really bad. Higher scores represent good palatability. Responses were summarized. Missing values were not imputed.~Palatability data was not collected in participants <2 years old."|Up to 96 hours|Full Analysis Set; participants aged 2 to less than 18 years were included in the analysis. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.|||Participants|||Count of Participants
2608065|NCT02081391|Secondary|Time From First Dose of IMP Until Treatment Discontinuation Due to Lack of Efficacy|"The distributions of the time from the first dose of IMP to treatment discontinuation due to lack of efficacy were summarized descriptively using time-to-event methods.~Participants who reached the maximum duration of treatment (72 hours) were censored at 72 hours after first IMP intake. Participants who discontinued during the Treatment Period for reasons other than lack of efficacy were censored at the time of the decision to discontinue treatment.~Due to the low number of participants with events in the age group from 2 to <18 years, the median time and the corresponding confidence interval could not be calculated. The number of participants who discontinued early due to lack of efficacy is presented instead."|Up to 72 hours|Full Analysis Set; 160 participants from 2 to less than 18 years were included in the analysis. If by error a participant did not receive the allocated medication, he/she was evaluated as allocated following the intention-to-treat principle. No participant <2 years was discontinued from treatment due to lack of efficacy; no analysis was performed.|||Participants|||Count of Participants
2608066|NCT02081391|Secondary|Time to Receive First and Second Patient- or Nurse-controlled Analgesia After the First Dose of IMP|"The time to first and time to second patient-controlled analgesia (PCA) or nurse-controlled analgesia (NCA) after the first dose of IMP were summarized descriptively using time-to-event methods and are displayed by relevant treatment groups. Participants who completed the End of Treatment Visit (scheduled for 96 hours after first IMP) before their first/second use of NCA/PCA or participants who terminated treatment before their first/second use of NCA/PCA were censored at the End of Treatment Visit.~Time-to-event variables are reported using Kaplan-Meier analyses. Therefore, values might remain missing if the survival function does not reach a respective threshold. This is indicated by not applicable (NA)."|Up to 96 hours|Full Analysis Set; 175 participants from birth to less than 18 years are included, censored participants are not displayed. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.|||minutes||95% Confidence Interval|Median
2608067|NCT02081391|Secondary|Patient Global Impression of Change (PGIC)|"The PGIC was assessed at the End of Treatment Visit (Day 4). Participants rated their impression of overall status on a 7-point scale with 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher scores indicate worsening. If participants were not capable of completing the questionnaire, the parent/legal guardian could completed the questionnaire on behalf of the participant.~Results were summarized descriptively."|Day 4|Full Analysis Set; 175 participants from birth to less than 18 years are included. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.|||Participants|||Count of Participants
2608068|NCT02081391|Secondary|Clinical Global Impression of Change (CGIC)|The CGIC was assessed at the End of Treatment Visit (Day 4). The investigator rated the participant's global improvement and satisfaction with the treatment on a 7-point scale with 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Higher scores indicate worsening. Results were summarized descriptively.|Day 4|Full Analysis Set; 175 participants from birth to less than 18 years are included. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.|||Participants|||Count of Participants
2608069|NCT02081391|Secondary|Change From Baseline in the Visual Analog Scale (VAS) Pain Intensity Score in Participants Aged 12 to Less Than 18 Years|"For children and adolescents aged 12 years to less than 18 years, pain intensity was assessed by the use of a Visual analog scale (VAS). The participant was asked to draw a single line to indicate the current level of pain intensity on a 100 mm long scale by marking a point on the line in response to: My pain right now is. The mark was scored between no pain and pain as bad as it could be. A value of 0 indicates no pain. A value of 100 indicates pain as bad as it could be. Pain intensity scores were obtained before and after first dose of IMP, and before each subsequent dose of IMP, whenever possible. Changes from baseline values were summarized descriptively for each time point."|Up to 96 hours|Full Analysis Set: subset of 78 participants aged from 12 to less than 18 years included in the analysis; participants with missing data are not included in the analysis. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.|||units on a scale||Standard Deviation|Mean
2608070|NCT02081391|Secondary|Change From Baseline Pain Intensity Using the Faces Pain Scale-Revised (FPS-R) in Participants Aged 6 to Less Than 12 Years|"For children aged 6 years (if possible) to less than 12 years, pain intensity was assessed by the use of the Faces Pain Scale-Revised (FPS-R). The FPS-R is a validated self-reported 6-point scale (0, 2, 4, 6, 8, 10) with 0 representing no pain and 10 representing very much pain. Facial representations were used to indicate how much the pain hurts. Higher scores represent worse condition.~Pain intensity scores were obtained before and after first dose of IMP, and before each subsequent dose of IMP, whenever possible.~Changes from baseline pain values were summarized descriptively for each time point up to end of treatment (96 hours)."|Up to 96 hours|Full Analysis Set: subset of 46 participants aged from 6 to less than 12 years included in the analysis; participants with missing data are not included in the analysis. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.|||units on a scale||Standard Deviation|Mean
2608071|NCT02081391|Secondary|Change From Baseline in the Face, Leg, Activity, Cry, and Consolability (FLACC) Total Score in Participants Aged Less Than 6 Years|"The FLACC scale was used for children from birth to less than 6 years, or in older children who were not able to report their pain using the other scales. This tool includes 5 categories of pain behaviors: facial expression (F), leg movement (L), activity (A), cry (C), and consolability (C). Each of the 5 categories is scored 0, 1 or 2. The total score between 0 and 10 is the sum of the 5 individual categories. Higher scores represent worse condition.~The Pain intensity scores were obtained before and after first dose of IMP, and before each subsequent dose of IMP, whenever possible, up to end of treatment (96 hours).~Changes from baseline values were summarized descriptively for each time point."|Up to 96 hours|Full Analysis Set: subset of 51 participants aged from birth to <6 years included in the analysis; participants with missing data were excluded from calculations. No standard deviations were derived for less than 5 participants.|||score on a scale||Full Range|Mean
2608072|NCT02081391|Secondary|Acceptability of IMP After First Dose Assessed Using Facial 5-point Hedonic Scale|"Acceptability of IMP in participants aged 2 years to less than 18 years was assessed using 5-point hedonic scales in combination with verbal rating. A question Swallowing the medication is... was asked and the verbal rating was from really good, good, a bit good/a bit bad, bad, and really bad. The pictorial scale of facial expressions was co-related with verbal rating range, with 5 = really easy, 4 = easy, 3 = a bit easy/a bit difficult, 2 = difficult, and 1 = really difficult. Higher scores represent better acceptability.~Responses were summarized. Missing values were not imputed. Acceptability data was not collected in participants <2 years old."|Up to 96 hours|Full Analysis Set: subset of 160 participants aged from 2 years to <18 years included in the analysis. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.|||Participants|||Count of Participants
2608099|NCT02081014|Secondary|Glucose Tmax (Post-insulin)|Pharmacodynamic parameter: Time to reach maximum concentration of glucose|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug|||minutes||Standard Error|Mean
2608073|NCT02081391|Secondary|Palatability of IMP After First Dose Assessed Using Facial 5-point Hedonic Scale|"Palatability of IMP after the first dose was assessed in participants aged 2 years to less than 18 years using 5-point hedonic scales in combination with verbal rating. A question How does the medication taste was asked and the verbal rating was from really good, good, a bit good/a bit bad, bad, and really bad. The pictorial scale of facial expressions was co-related with verbal rating range where 5 = really good, 4 = good, 3 = a bit good/a bit bad, 2 = bad, and 1 = really bad. Higher scores represent good palatability. Responses were summarized. Missing values were not imputed.~Palatability data was not collected for participants <2 years old."|Up to 96 hours|Full Analysis Set; subset of 160 participants aged from 2 years to less than 18 years included in the analysis. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.|||Participants|||Count of Participants
2608074|NCT02081391|Secondary|Total Amount of Supplemental Opioid Analgesic Medication Received, Assessed in 12-hour Intervals From 24 Hours to 96 Hours After the First Dose of IMP|"The total amount of supplemental opioid analgesic medication (SOAM) received was assessed in 12-hour intervals from 24 hours to 96 hours after the first dose of IMP for participants who were administered SOAM.~SOAM use was expressed in mg/kg of morphine i.v. equivalents."|Up to 96 hours|Full Analysis Set; 175 participants aged from birth to <18 years; participants with no documented SOAM use in the respective time period are excluded from calculations. When 0 participants are indicated in the Row Analyzed that means no data was collected.|||mg/kg||Full Range|Mean
2608075|NCT02081391|Primary|For the EU PDCO: The Total Amount of Supplemental Opioid Analgesic Medication Used Within the First 24 Hours After First Intake of IMP [Tapentadol Oral Solution or Placebo]|The primary endpoint for the EU PDCO (and secondary endpoint for the US FDA) was the total amount of supplemental opioid analgesic medication (SOAM) used in the Full Analysis Set (from 2 years to <18 years old) within 24 hours after first intake of IMP. SOAM use is expressed in mg/kg of morphine i.v. equivalents.|Up to 24 hours|Full Analysis Set; subset of 160 participants from 2 to less than 18 years included in the analysis; if by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.|||mg/kg||Standard Error|Least Squares Mean
2608076|NCT02081391|Primary|For the US FDA: The Total Amount of Supplemental Opioid Analgesic Medication Used Within the First 12 Hours After First Intake of Investigational Medicinal Product (IMP) [Tapentadol Oral Solution or Placebo]|The primary endpoint for the United States Food and Drug Administration (US FDA) (and secondary endpoint for the Pediatric Committee of the European Medicines Agency [EU PDCO]) was the total amount of supplemental opioid analgesic medication (SOAM) used in the Full Analysis Set (from 2 years to <18 years old) within 12 hours after first intake of IMP. SOAM use is expressed in mg/kg of morphine i.v. equivalents.|Up to 12 hours|Full Analysis Set; subset of 160 participants from 2 to less than 18 years included in the analysis. If by error a participant did not receive the allocated medication, the participant was evaluated as allocated following the intention-to-treat principle.|||mg/kg||Standard Error|Least Squares Mean
2608077|NCT02081365|Secondary|Change in Avoidance Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV|The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. For the present investigation, only the specific phobia module of the ADIS-IV was administered to assess the presence and severity of a current diagnosis of dental phobia. Various aspects of dental phobia were assessed using the specific phobia module of the ADIS-IV. Interviewers assessed participants' anxiety and avoidance of dental procedures on scales that ranged from 0 (none) to 8 (very severe). They also rated patients' overall distress and impairment due to their dental phobia symptoms and assigned a clinician's severity rating (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR > 4 indicated that the participant met criteria for diagnosis of dental phobia.|Change from one week before appointment to one month after appointment||||units on a scale||Standard Error|Mean
2608078|NCT02081365|Secondary|Change in Fear Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV|The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. For the present investigation, only the specific phobia module of the ADIS-IV was administered to assess the presence and severity of a current diagnosis of dental phobia. Various aspects of dental phobia were assessed using the specific phobia module of the ADIS-IV. Interviewers assessed participants' anxiety and avoidance of dental procedures on scales that ranged from 0 (none) to 8 (very severe). They also rated patients' overall distress and impairment due to their dental phobia symptoms and assigned a clinician's severity rating (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR > 4 indicated that the participant met criteria for diagnosis of dental phobia.|Change from one week before appointment to one month after appointment||||units on a scale||Standard Error|Mean
2608079|NCT02081365|Secondary|Change in Clinical Severity Rating for Specific Phobia Module of Anxiety Disorders Interview Schedule for DSM-IV|The Anxiety Disorders Interview Schedule for DSM-IV is a semi-structured diagnostic interview for assessing DSM-IV criteria for current anxiety, depressive, somatoform, and substance use disorders. For the present investigation, only the specific phobia module of the ADIS-IV was administered to assess the presence and severity of a current diagnosis of dental phobia. Various aspects of dental phobia were assessed using the specific phobia module of the ADIS-IV. Interviewers assessed participants' anxiety and avoidance of dental procedures on scales that ranged from 0 (none) to 8 (very severe). They also rated patients' overall distress and impairment due to their dental phobia symptoms and assigned a clinician's severity rating (CSR) that also ranged from 0 (none) to 8 (very severe); a CSR > 4 indicated that the participant met criteria for diagnosis of dental phobia.|Change from one week before dental appointment to one-month after dental appointment||||units on a scale||Standard Error|Mean
2608095|NCT02081079|Secondary|Percentage of Patients With Virologic Failure|"Virologic failure was defined as either:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment); or~Relapse:~HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment"|Up to posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2608080|NCT02081365|Primary|Change in Modified Dental Anxiety Scale|"The Modified Dental Anxiety Scale a five-item self-report measure that assesses fear of dental procedures, including drilling, scaling and polishing (i.e., cleaning), and local anesthetic injections. Sample items include, If you went to your dentist for treatment tomorrow, how would you feel? and If you were about to have your tooth drilled, how would you feel? Items are rated on a five-point Likert-type scale ranging from 1 (not anxious) to 5 (extremely anxious). Scale 0-25. We considered patients who scored > 19 on the MDAS at baseline or endorsed at least two MDAS items > 4 to have high dental anxiety."|Change from one week before dentist appointment to 1 month after dentist appointment||||units on a scale||Standard Error|Mean
2608081|NCT02081248|Secondary|Consent Rate on Parent Trial|The consent rate is the rate at which participants provided consent to participate in the parent trial.|Within 7 days of consent discussion|Consent rates are computed specific to each trial|||Participants|||Count of Participants
2608082|NCT02081248|Secondary|Participant Information Location Time|Participants are asked to identify select items within the consent document and the time taken to locate items is measured. Patients who were not able to identify a given section were assigned the maximum time allotted to find each section (180 seconds).|Within 7 days of consent discussion|Participants completing the information location assessment|||seconds||Inter-Quartile Range|Median
2608083|NCT02081248|Secondary|Participant Satisfaction With Consent Process|A short study specific questionnaire and selected questions from the Quality of Informed Consent (QuIC) supplement questionnaire will query participants about their overall satisfaction with the consent process, helpfulness of information provided, and comprehension of key study-specific elements of treatment. Seven questions are included, each scored on a five point Likert scale. The overall score is the average of the item scores, ranging from 1.0 to 5.0, with a higher score indicating a higher level of satisfaction.|Within 7 days of consent discussion|Participants completing the satisfaction questionnaire|||units on a scale||Inter-Quartile Range|Median
2608084|NCT02081248|Secondary|State Trait Anxiety Inventory (STAI) Score|"The State Trait Anxiety Inventory (STAI) measures anxiety and distinguishes it from depressive syndromes. It has two subscales: the State Anxiety Scale evaluates the current state of anxiety, asking how respondents feel right now, and Trait Anxiety Scale evaluating relatively stable aspects of anxiety proneness. The STAI has 40 items, 20 items allocated to each subscale, with each item scored on a 4 point Likert scale. The subscale scores shown are averages of the items in the subscale ranging from 1.0 to 4.0, with a higher score indicating a greater level of anxiety."|Within 7 days of consent discussion|Participants completing the STAI assessment|||units on a scale||Inter-Quartile Range|Median
2608085|NCT02081248|Secondary|Newest Vital Sign (NVS) Score|The Newest Vital Sign is a screening tool that identifies patients at risk for low health literacy. It consists of a nutritional label accompanied by five questions about information on the label. The score is equal to the number of questions answered correctly.|Within 7 days of consent discussion||||Participants|||Count of Participants
2608086|NCT02081248|Secondary|REALM-R Score|The Rapid Estimate of Adult Literacy in Medicine—Revised (REALM-R) is an 8-item word recognition test to provide clinicians with a valid quick assessment of patient health literacy. The score is computed as the number of words out of 8 that the patient pronounces correctly.|Within 7 days of consent discussion||||Participants|||Count of Participants
2608087|NCT02081248|Secondary|Modified Deaconess Informed Consent Comprehension Test (DICCT)|The Modified Deaconess Informed Consent Comprehension Test (DICCT) uses semi-structured interviews to assess subject's understanding of the study for which they participated in an informed consent discussion. This modification of the DICCT has 11 items, each scored from 0 to 2 (0 = incorrect, 1 = partially correct, 2 = correct). The item scores are summed to produce a total score ranging from 0 to 22. A higher score indicates a higher level of comprehension.|WIthin 7 days of consent discussion|Participants completing the modified DICCT assessment|||units on a scale||Inter-Quartile Range|Median
2608088|NCT02081248|Secondary|Quality of Informed Consent Part B (QuIC-B) Score|The Quality of Informed Consent Part B measures participants' perception of their understanding of cancer clinical trials to address 13 independent domains of informed consent. The QuIC-B is scored on a normalized scale from 0 to 100, with a higher score indicating a greater level of perceived understanding.|Within 7 days of consent discussion|Participants completing the QuIC-B assessment|||units on a scale||Inter-Quartile Range|Median
2608089|NCT02081248|Primary|Quality of Informed Consent Part A (QuIC-A) Score|The primary objective of the trial is to compare objective comprehension scores on the Quality of Informed Consent (part A) instrument between subjects randomized to the ETRIC versus the standard consent arms. The QuIC-A is scored on a normalized scale from 0 to 100, with a higher score indicating a greater level of comprehension.|Within 7 days of consent discussion|Participants completing the QuIC-A assessment|||units on a scale||Standard Deviation|Mean
2608090|NCT02081183|Primary|Serum Albumin|Albumin is a protein made by the liver. A serum albumin test measures the amount of this protein in the clear liquid portion of the blood. Decreased serum albumin levels can be an indicator of liver and/or kidney disease, The normal range is 3.4 - 5.4 grams (g)/dL.|18 months|Data were not analyzed because the study was terminated early.||||||
2608091|NCT02081183|Primary|Serum Creatinine|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males, however the normal values are age-dependent as elderly participants typically have smaller muscle mass.|18 months|Data were not analyzed because the study was terminated early.||||||
2608092|NCT02081183|Primary|Urinary Protein|Protein in urine is an indicator of kidney function. An increased urinary protein level indicates decreased kidney function. Normal values are approximately 0 to 8 milligrams per deciliter (mg/dL).|18 months|Data were not analyzed because the study was terminated early.||||||
2608093|NCT02081183|Primary|Creatinine Clearance|Creatinine clearance in an indicator of kidney function. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult values are 97 to 137 milliliters per minute (mL/min) for males and 88 to 128 mL/min for females.|18 months|Data were not analyzed because the study was terminated early.||||||
2608094|NCT02081079|Secondary|Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12||Baseline; Weeks 2, 4, 8, and 12|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
2608100|NCT02081014|Secondary|Glucose Tmax (Fasting)|Pharmacodynamic parameter: Time to reach maximum concentration of glucose|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|All randomized subjects who received at least one dose of study drug|||minutes||Standard Error|Mean
2608101|NCT02081014|Secondary|Glucose AUC (Post-insulin)|Pharmacodynamic parameter: baseline adjusted area under the glucose concentration curve from 0-120 minutes|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug|||(mg/dl)*minutes||Standard Error|Mean
2608102|NCT02081014|Secondary|Glucose AUC (Fasting)|Pharmacodynamic parameter: baseline adjusted area under the glucagon concentration curve from 0 to 120 minutes|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug|||(mg/dl)*minutes||Standard Error|Mean
2608103|NCT02081014|Secondary|Glucose Cmax (Post-insulin)|Pharmacodynamic parameter: Maximum concentration of glucose|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug|||mg/dl||Standard Error|Mean
2608104|NCT02081014|Secondary|Glucose Cmax (Fasting)|Pharmacodynamic parameter: Maximum concentration of glucose|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|All randomized subjects who received at least one dose of study drug|||mg/dl||Standard Error|Mean
2608105|NCT02081014|Secondary|Glucagon Tmax (Post-insulin)|Pharmacokinetic parameter: Time to reach maximum concentration of glucagon|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug|||minutes||Standard Error|Mean
2608106|NCT02081014|Secondary|Glucagon Tmax (Fasting)|Pharmacokinetic parameter: Time to reach maximum concentration of glucagon|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|All randomized subjects who received at least one dose of study drug|||minutes||Standard Error|Mean
2608107|NCT02081014|Secondary|Glucagon AUC (Post-insulin)|Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug|||(pg/ml)*hour||Standard Error|Mean
2608108|NCT02081014|Secondary|Glucagon Area Under the Curve (AUC) (Fasting)|Pharmacokinetic parameter: Area under the glucagon concentration curve from 0 to 120 minutes|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subjects who received at least one dose of study drug|||(pg/ml)*hour||Standard Error|Mean
2608109|NCT02081014|Secondary|Glucagon Cmax (Post-insulin)|Pharmacokinetic parameter: Maximum concentration of glucagon|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, and 120 minutes post-injection|All randomized subject who received at least one dose of study drug|||pg/ml||Standard Error|Mean
2608110|NCT02081014|Secondary|Glucagon Cmax (Fasting)|Pharmacokinetic parameter: Maximum concentration of glucagon|Approximately 15 and 0 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 180 minutes post-injection|All randomized subjects who received at least one dose of study drug|||pg/ml||Standard Error|Mean
2608111|NCT02081014|Primary|Serious Adverse Events|Number of serious adverse events (SAEs) per treatment|From first dose until follow-up call, up to 7 weeks per subject|All randomized subjects who received at least one dose of study drug|||participants|||Number
2608112|NCT02081001|Secondary|Infusion Site Discomfort Score at 30 Minutes|Infusion site discomfort was assessed by the subject using a 100 mm Visual Analog Scale (VAS) questionnaire at 30 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score.|At 30 minutes post-dosing|All treated subjects|||mm||Standard Deviation|Mean
2608113|NCT02081001|Secondary|Infusion Site Discomfort Score at 10 Minutes|Infusion site discomfort was assessed by the subjects using a 100 mm Visual Analog Scale (VAS) questionnaire at 10 minutes following the initiation of dosing. Subjects were asked to draw a vertical line across the horizontal scale to indicate their current level of discomfort from 0 = no discomfort to 100 = worst possible discomfort. The distance in mm from the left hand anchor to the the first point where the subject's mark crossed the horizontal scale was measured and reported as the infusion site discomfort score.|At 10 minutes post-dosing|All treated subjects|||mm||Standard Deviation|Mean
2608114|NCT02081001|Secondary|Glucose AUC|Area under the plasma concentration time curve for glucose|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.|||(mg/dl)*minutes||Standard Deviation|Mean
2608115|NCT02081001|Secondary|Glucagon AUC|Area under the plasma concentration time curve for glucagon|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.|||(pg/dl)*minutes||Standard Deviation|Mean
2608116|NCT02081001|Secondary|Glucose Tmax|Time to maximum plasma concentration of glucose|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. In addition, subjects with no increase in glucose concentration post-dosing (i.e., maximum concentration was at time zero) were not evaluable for response and consequently were not included in the analysis.|||minutes||Standard Deviation|Mean
2608117|NCT02081001|Secondary|Glucagon Tmax|Time to maximum plasma concentration of glucagon|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.|||minutes||Standard Deviation|Mean
2608118|NCT02081001|Secondary|Glucose Cmax|Maximum plasma concentration of glucose|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.|||mg/dl||Standard Deviation|Mean
2608119|NCT02081001|Secondary|Glucagon Cmax|Maximum plasma concentration of glucagon|From 0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.|||pg/dl||Standard Deviation|Mean
2608120|NCT02081001|Primary|Time to Reach 50% of Maximum Glucagon Concentration (Glucagon T50%-Early)|The speed of absorption was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucagon following each dose of glucagon.|0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis.|||minutes||Standard Deviation|Mean
2608121|NCT02081001|Primary|Time to Reach 50% of Maximum Glucose Concentration (Glucose T50%-Early)|The onset of action was assessed by determining the time in minutes required to achieve 50% of the maximum plasma concentration of glucose following each dose of glucagon.|0 to 150 minutes post-dosing|All randomized, evaluable subjects. Two subjects not evaluable for response to GlucaGen due to dosing errors were excluded from the analysis. In addition, subjects with no increase in glucose concentration post-dosing (i.e., maximum concentration was at time zero) were not evaluable for response and consequently were not included in the analysis.|||minutes||Standard Deviation|Mean
2608122|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Own Health State|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 36 months.|36 Months|Population includes subjects available at 36 months with relevant data.|||Participants|||Count of Participants
2608123|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Own Health State|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 24 months.|24 Months|Population includes subjects available at 24 months with relevant data.|||Participants|||Count of Participants
2608124|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Own Health State|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 12 months.|12 Months|Population includes subjects available at 12 months with relevant data.|||Participants|||Count of Participants
2608125|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 36 months.|36 Months|Population includes subjects available at 36 months with relevant data.|||Participants|||Count of Participants
2608126|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 24 months.|24 Months|Population includes subjects available at 24 months with relevant data.|||Participants|||Count of Participants
2608127|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 12 months.|12 Months|Population includes subjects available at 12 months with relevant data.|||Participants|||Count of Participants
2608128|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 36 months.|36 Months|Population includes subjects available at 36 months with relevant data.|||Participants|||Count of Participants
2608129|NCT02080871|Other Pre-specified|Major Amputation|Number of subjects experiencing a major amputation of the target limb within 9 months - Component of primary outcome|9 Months|Population includes subjects followed for at least 240 days.|||Participants|||Count of Participants
2608130|NCT02080871|Other Pre-specified|Target Lesion Revascularization (TLR)|Number of subjects experiencing a target lesion revascularization (TLR) within 9 months - Component of primary outcome|9 Months|Population includes subjects followed for at least 240 days.|||Participants|||Count of Participants
2608131|NCT02080871|Other Pre-specified|Myocardial Infarction (MI)|Number of subjects experiencing a myocardial infarction (MI) within 30 Days - Component of primary outcome|30 Days|Population includes subjects followed for at least 30 days.|||Participants|||Count of Participants
2608132|NCT02080871|Other Pre-specified|Device or Procedure-related Death|Number of subjects experiencing a device or procedure-related death within 30 Days - Component of primary outcome|30 Days|Population includes subjects followed for at least 30 days.|||Participants|||Count of Participants
2608133|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 24 months.|24 Months|Population includes subjects available at 24 months with relevant data.|||Participants|||Count of Participants
2608134|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 12 months.|12 Months|Population includes subjects available at 12 months with relevant data.|||Participants|||Count of Participants
2608135|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Usual Activities|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 36 months.|36 Months|Population includes subjects available at 36 months with relevant data.|||Participants|||Count of Participants
2608136|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Usual Activities|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 24 months.|24 Months|Population includes subjects available at 24 months with relevant data.|||Participants|||Count of Participants
2608711|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Cmax; The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
2608137|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Usual Activities|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 12 months.|12 Months|Population includes subjects available at 12 months with relevant data.|||Participants|||Count of Participants
2608138|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Self Care|Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 36 months.|36 Months|Population includes subjects available at 36 months with relevant data.|||Participants|||Count of Participants
2608139|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Self Care|Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 24 months.|24 Months|Population includes subjects available at 24 months with relevant data.|||Participants|||Count of Participants
2608140|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Self Care|Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 12 months.|12 Months|Population includes subjects available at 12 months with relevant data.|||Participants|||Count of Participants
2608141|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Mobility|Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 36 months.|36 Months|Population includes subjects available at 36 months with relevant data.|||Participants|||Count of Participants
2608142|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Mobility|Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 24 months.|24 Months|Population includes subjects available at 24 months with relevant data.|||Participants|||Count of Participants
2608143|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Mobility|Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 12 months.|12 Months|Population includes subjects available at 12 months with relevant data.|||Participants|||Count of Participants
2608144|NCT02080871|Secondary|Change in Ankle Brachial Index (ABI)|Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.|36 Months|Population includes subjects available at 36 Months with relevant data.|||ratio index|Limbs|Full Range|Mean
2608145|NCT02080871|Secondary|Change in Ankle Brachial Index (ABI)|Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.|24 Months|Population includes subjects available at 24 Months with relevant data.|||ratio index|Limbs|Full Range|Mean
2608146|NCT02080871|Secondary|Change in Ankle Brachial Index (ABI)|Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.|12 Months|Population includes subjects available at 12 Months with relevant data.|||ratio index|Limbs|Full Range|Mean
2608147|NCT02080871|Secondary|Number of Participants With Change in Rutherford Category|"Number of participants with change in Rutherford Category from pre-procedure at 36 months.~Rutherford Categories:~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene"|36 Months|Population includes subjects available at 36 Months with relevant data.|||Participants|||Count of Participants
2608148|NCT02080871|Secondary|Number of Participants With Change in Rutherford Category|"Number of participants with change in Rutherford Category from pre-procedure at 24 months.~Rutherford Categories:~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene"|24 Months|Population includes subjects available at 24 Months with relevant data.|||Participants|||Count of Participants
2608149|NCT02080871|Secondary|Number of Participants With Change in Rutherford Category|"Number of participants with change in Rutherford Category from pre-procedure at 12 months.~Rutherford Categories:~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene"|12 Months|Population includes subjects available at 12 Months with relevant data.|||Participants|||Count of Participants
2608150|NCT02080871|Secondary|Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)|Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 36 months|36 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608151|NCT02080871|Secondary|Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)|Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 24 months|24 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608152|NCT02080871|Secondary|Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)|Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 12 months|12 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608153|NCT02080871|Secondary|Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)|Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 36 months.|36 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608154|NCT02080871|Secondary|Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)|Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 24 months.|24 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608155|NCT02080871|Secondary|Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)|Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 12 months.|12 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608156|NCT02080871|Secondary|Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)|Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 36 months.|36 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608157|NCT02080871|Secondary|Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)|Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 24 months.|24 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608158|NCT02080871|Secondary|Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)|Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months.|12 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608159|NCT02080871|Secondary|Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)|Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 36 months.|36 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608160|NCT02080871|Secondary|Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)|Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 24 months.|24 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608161|NCT02080871|Secondary|Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)|Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 12 months.|12 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608162|NCT02080871|Secondary|Percentage of Participants With Secondary Patency|Kaplan-Meier estimate of secondary patency at 12 months.|12 Months|Population includes all subjects meeting eligibility.|||survival percentage by subject||95% Confidence Interval|Number
2608163|NCT02080871|Secondary|Percentage of Participants With Primary Assisted Patency|Kaplan-Meier estimate of primary assisted patency at 12 months.|12 Months|Population includes all subjects meeting eligibility.|||survival percentage by subject||95% Confidence Interval|Number
2608164|NCT02080871|Secondary|Percentage of Participants With Primary Patency|Kaplan-Meier estimate of primary patency at 12 months.|12 Months|Population includes all subjects meeting eligibility.|||survival percentage by subject||95% Confidence Interval|Number
2608165|NCT02080871|Secondary|Number of Participants With Improvement in Functional Status 9 Months - Walking Improvement Questionnaire (WIQ)|Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 9 months.|9 Months|Population includes subjects followed for at least 240 days and had relevant data.|||Participants|||Count of Participants
2608166|NCT02080871|Secondary|Number of Participants With Improvement in Functional Status at 30 Days - Walking Improvement Questionnaire (WIQ)|Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||Participants|||Count of Participants
2608167|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Own Health State|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 9 months.|9 Months|Population includes subjects followed for at least 240 days and had relevant data.|||Participants|||Count of Participants
2608168|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Own Health State|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 30 days.|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||Participants|||Count of Participants
2608169|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 9 months.|9 Months|Population includes subjects followed for at least 240 days and had relevant data.|||Participants|||Count of Participants
2608170|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days.|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||Participants|||Count of Participants
2608171|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 9 months.|9 Months|Population includes subjects followed for at least 240 days and had relevant data.|||Participants|||Count of Participants
2610609|NCT02054156|Secondary|Adverse Events (AEs) and Serious Adverse Events (SAEs)|The number and percentage of participants with at least one event over the 18-month study period.|Over the 18-month study period||||Participants|||Count of Participants
2608172|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days.|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||Participants|||Count of Participants
2608173|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Usual Activities|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 9 months.|9 Months|Population includes subjects followed for at least 240 days and had relevant data.|||Participants|||Count of Participants
2608174|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Usual Activities|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days.|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||Participants|||Count of Participants
2608175|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Self Care|Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 9 months.|9 Months|Population includes subjects followed for at least 240 days and had relevant data.|||Participants|||Count of Participants
2608176|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Self Care|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Self Care) from pre-procedure at 30 days.|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||Participants|||Count of Participants
2608177|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Mobility|Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 9 months.|9 Months|Population includes subjects followed for at least 240 days and had relevant data.|||Participants|||Count of Participants
2608178|NCT02080871|Secondary|Number of Participants With Change in Functional Status - EQ5D - Mobility|Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Mobility) from pre-procedure at 30 days.|30 Days|Population includes subjects followed for at least 23 days and had relevant data.|||Participants|||Count of Participants
2608179|NCT02080871|Secondary|Change in Ankle Brachial Index (ABI)|Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.|9 Months|Population includes subjects followed for at least 240 days and had relevant data.|||ratio index|limbs|Full Range|Mean
2608180|NCT02080871|Secondary|Change in Ankle Brachial Index (ABI)|Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.|30 Days|Population includes subjects followed for at least 23 days and had relevant data.|||ratio index|limbs|Full Range|Mean
2608181|NCT02080871|Secondary|Number of Participants With Change in Rutherford Category|"Number of participants with change in Rutherford Category from pre-procedure at 9 months.~Rutherford Categories:~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene"|9 Months|Population includes subjects followed for at least 240 days and relevant data.|||Participants|||Count of Participants
2608182|NCT02080871|Secondary|Number of Participants With Change in Rutherford Category|"Number of participants with change in Rutherford Category from pre-procedure at 30 days.~Rutherford Categories:~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene"|30 Days|Population includes subjects followed for at least 23 days and had relevant data.|||Participants|||Count of Participants
2608183|NCT02080871|Secondary|Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)|Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 9 months|9 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608184|NCT02080871|Secondary|Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)|Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 30 days.|30 Days|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608185|NCT02080871|Secondary|Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)|Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 9 months.|9 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608186|NCT02080871|Secondary|Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)|Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days.|30 Days|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608187|NCT02080871|Secondary|Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)|Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 9 months.|9 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608712|NCT02074995|Primary|Efficacy Measure by Change in Lean Body Mass (LBM)|Total LBM is measured by dual energy X-ray absorptiometry (DXA) scan.|Groups 2,3&4: Baseline, Day 35, Day 85 and Day 106|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
2608188|NCT02080871|Secondary|Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)|Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 30 days.|30 Days|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608189|NCT02080871|Secondary|Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)|Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 9 months.|9 Months|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608190|NCT02080871|Secondary|Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)|Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days.|30 Days|Population includes all subjects meeting eligibility.|||Percentage of participants||95% Confidence Interval|Number
2608191|NCT02080871|Secondary|Percentage of Participants With Secondary Patency|Kaplan-Meier estimate of secondary patency at 9 months.|9 Months|Population includes all subjects meeting eligibility.|||survival percentage by subject||95% Confidence Interval|Number
2608192|NCT02080871|Secondary|Percentage of Participants With Secondary Patency|Kaplan-Meier estimate of secondary patency at 30 days.|30 Days|Population includes all subjects meeting eligibility.|||survival percentage by subject||95% Confidence Interval|Number
2608193|NCT02080871|Secondary|Percentage of Participants With Primary Assisted Patency|Kaplan-Meier estimate of primary assisted patency at 9 months.|9 Months|Population includes all subjects meeting eligibility.|||survival percentage by subject||95% Confidence Interval|Number
2608194|NCT02080871|Secondary|Percentage of Participants With Primary Assisted Patency|Kaplan-Meier estimate of primary assisted patency at 30 days.|30 Days|Population includes all subjects meeting eligibility.|||survival percentage by subject||95% Confidence Interval|Number
2608195|NCT02080871|Secondary|Percentage of Participants With Primary Patency|Kaplan-Meier estimate of primary patency at 9 months.|9 Months|Population includes all subjects meeting eligibility.|||survival percentage by subject||95% Confidence Interval|Number
2608196|NCT02080871|Secondary|Percentage of Participants With Primary Patency|Kaplan-Meier estimate of primary patency at 30 days.|30 Days|Population includes all subjects meeting eligibility.|||survival percentage by subject||95% Confidence Interval|Number
2608197|NCT02080871|Secondary|30-Day Clinical Success|Number of subjects who experienced 30-Day Clinical Success defined as an improvement of at least one Rutherford Category at the 30-day visit as compared to pre-procedure and no device- or procedure-related SAEs within 30 days of the index procedure.|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||Participants|||Count of Participants
2608198|NCT02080871|Secondary|Acute Procedural Success|Number of subjects who experienced Acute Procedural Success defined as less than or equal to 30% residual stenosis prior to procedure completion and no device- or procedure-related SAEs before discharge.|Discharge|Population includes subjects followed through discharge and had relevant procedural data.|||Participants|||Count of Participants
2608199|NCT02080871|Primary|Composite of Major Adverse Events (MAEs)|Percentage of study subjects experiencing a major adverse event (MAE) defined as: device or procedure-related death within 30 days, myocardial infarction (MI) within 30 days, target lesion revascularization (TLR) within 9 months or major amputation of the target limb within 9 months.|9 months|Population includes enrolled subjects who either experienced the defined event or were followed for at least 240 days.|||percentage of subjects experiencing MAE||95% Confidence Interval|Number
2608200|NCT02080832|Other Pre-specified|fMRI Brain Activation in Right Orlandic Operculum|Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score.|Baseline||||percent of significant voxels in cluster|||Number
2608201|NCT02080832|Other Pre-specified|fMRI Brain Activation in Right Precentral Gyrus|Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score.|Baseline||||percent of significant voxels in cluster|||Number
2608202|NCT02080832|Other Pre-specified|fMRI Brain Activation in Right Inferior Frontal Gyrus|Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score.|Baseline||||Percent of significant voxels in cluster|||Number
2608203|NCT02080832|Primary|Cocaine Use/Treatment Effectiveness Score (TES)|Number of benzoylecgonine negative urines divided by the total number of urines collected|8 weeks of treatment||||percentage of negative urines|||Number
2608204|NCT02080819|Primary|Cocaine Treatment Outcome|Treatment effectiveness score based on number of positive urine drug screens|Baseline to 12 weeks||||positive drug screens||Standard Deviation|Mean
2608205|NCT02080780|Primary|Peak Plasma Concentration (Cmax) of 2% Diltiazem|To evaluate the drug-drug interaction potential of clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.|9 days||||ng / mL||Standard Deviation|Mean
2608206|NCT02080637|Secondary|Duration of Chest Tube Drainage Post Fontan Operation|Chest tube duration will be calculated as the number of days from placement to removal.|measured for the duration of the post-operative hospitalization or for 30 days, whichever is shorter||||days||Standard Deviation|Mean
2608207|NCT02080637|Secondary|Amount of Chest Tube Drainage Post Fontan Operation|Total chest tube drainage in mL in first 96hrs after Fontan|0-96 hours post Fontan||||milliliters||Standard Deviation|Mean
2608208|NCT02080637|Primary|Change in Pulmonary Vascular Resistance Index|Hemodynamic data, including Fontan pressures, common atrial pressures and saturations, will be collected at the specified timepoints. Pressures and saturations will be measured from existing monitoring lines. Standard Fick calculations will be used to calculate pulmonary vascular resistance (calculated as trans-pulmonary gradient [Fontan pressure - atrial pressure] / pulmonary blood flow [Qp]) and reported in Wood Units x m^2.|baseline to 2 hours post ambrisentan administration|One participant in the Ambrisentan group had central line removed early; Fontan pressures could not be measured.|||WU*m^2||Standard Deviation|Mean
2608713|NCT02074995|Primary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Number of patients with adverse events as a measure of safety and tolerability|Over 1 year||||Participants|||Number
2608209|NCT02080637|Primary|Area Under the Curve for Ambrisentan Plasma Concentration|Plasma samples collected at 0-1,1-6,18-30 and 40-60 hours after administration of the first ambrisentan dose.|0-1,1-6,18-30 and 40-60 hours|Five participants did not have all samples collected. Outcome measure not applicable to the Placebo group.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2608210|NCT02080546|Secondary|Incidence of Clinical Surrogates of Compromised Vaginal Cuff Healing|a difference between arms in the proportion of patients who have at least one of the following post-operatively: vaginal vault granulation tissue, vaginal cuff separation/dehiscence, or vaginal apex infection|4 weeks, 3 months, and 6 months after hysterectomy for a post-operative check and pelvic examination|This secondary objective was not evaluated|||participants||95% Confidence Interval|Number
2608211|NCT02080546|Primary|Degree of Thermal Injury at the Time of Laparoscopic Hysterectomy|"distance in millimeters over which thermal tissue injury extends (henceforth referred to as injury)."|up to 36 months|49 participants were included in the cut/coag arm and 52 participants in the V mode arm. Thermal injury was assessed at the anterior margin in 91 specimens and at the posterior margin in 93 specimens.|||mm|Participants|Full Range|Mean
2608212|NCT02080507|Secondary|Quality of Life Assessed by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-Les-SF) Score|The Q-Les-SF assesses the degree of enjoyment and satisfaction experienced by individuals in various areas of daily functioning. The minimum raw score is 14, and the maximum score is 70. Higher scores indicate better satisfaction with life domains (physical health, feelings, work, household duties, school/course work, leisure time activities, and social relations).|Baseline, Week 6||||units on a scale||Standard Deviation|Mean
2608213|NCT02080507|Primary|Depression Severity as Assessed by the Montgomery Åsberg Depression Rating Scale (MADRS) Score|The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. The MADRS-S instrument has nine questions, with an overall score ranging from 0 to 60 points. A higher score indicates greater depressive symptoms.|Baseline, Week 6||||units on a scale||Standard Deviation|Mean
2608214|NCT02080481|Secondary|Percentage of Time With Perfect Needle Visibility|Percentage of time that perfect needle visibility was visualized on ultrasound.|From start of block procedure until block placement||||percentage of time||Standard Deviation|Mean
2608215|NCT02080481|Secondary|> 1 Block Attempt|Number of block attempts was collected for each patient as > 1 block attempt versus 1 attempt. A block attempt was defined as pulling the block needle back to skin and redirecting it.|from start of block procedure until block placement||||Participants|||Count of Participants
2608216|NCT02080481|Secondary|Block Failure|Number of patients who had block failure|start of surgery until femoral nerve block completion||||Participants|||Count of Participants
2608217|NCT02080481|Primary|Time Spent in Performing Ultrasound Guided Femoral Nerve Blocks With InfinitiPlusTM Needle Guidance System||time elapsed from beginning the block procedure (after prepping and draping) until the catheter was successfully inserted or the end of the day of surgery.||||seconds||Inter-Quartile Range|Median
2608218|NCT02080468|Secondary|t1/2 for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)|Apparent terminal elimination half-life of lomitapide and its metabolites, M1 & M3.|1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing|The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.|||hr||Geometric Coefficient of Variation|Geometric Mean
2608219|NCT02080468|Secondary|AUC0-∞ for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)|Area under the concentration-time curve from zero to infinity of lomitapide and its metabolites, M1 & M3.|1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing|The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2608220|NCT02080468|Secondary|AUC0-t for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)|Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its metabolites, M1 & M3.|1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing|The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2608221|NCT02080468|Secondary|Tmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)|Time to reach maximum observed plasma concentration of lomitapide and its metabolites, M1 & M3.|1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing|The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.|||hr||Full Range|Mean
2608222|NCT02080468|Secondary|Cmax for Arm 2 (Lomitapide & EE/Noregestimate - 12 Hours Apart)|Maximum observed plasma concentration of lomitapide and its metabolites, M1 & M3.|1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing|The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2608223|NCT02080468|Primary|t1/2 for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)|Apparent terminal elimination half-life of lomitapide and its 2 primary metabolites, M1 & M3.|1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing|The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.|||hr||Geometric Coefficient of Variation|Geometric Mean
2608224|NCT02080468|Primary|AUC0-∞ for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)|Area under the concentration-time curve from zero to infinity of lomitapide and its 2 primary metabolites, M1 & M3.|1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing|The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2608225|NCT02080468|Primary|AUC0-t for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)|Area under the concentration-time curve from zero to last quantifiable concentration of lomitapide and its 2 primary metabolites, M1 & M3.|1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing|The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2608226|NCT02080468|Primary|Tmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)|Time to reach maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 & M3.|1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing|The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.|||hr||Full Range|Median
2608227|NCT02080468|Primary|Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together)|Maximum observed plasma concentration of lomitapide and its 2 primary metabolites, M1 & M3|1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 169 hours after dosing|The Pharmacokinetic Analysis population included all subjects. Only subjects who completed both periods were included in the ANOVA analyses.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2608228|NCT02080455|Secondary|t1/2|Apparent terminal elimination half-life of lomitapide and its 2 primary metabolites (M1 & M3) following administration of lomitapide alone and coadministered with atorvastatin 12 hours apart (Arm 2)|Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data. 3 subjects were removed from formal statistical analysis due to BLQ values on Day 1, missing value of AUC0-∞ on Day 1, and missing value of AUC0-∞ on Day 15.|||hr||Geometric Coefficient of Variation|Geometric Mean
2608229|NCT02080455|Secondary|AUC0-∞|Area under the concentration-time curve from zero to infinity of lomitapide and its 2 primary metabolites (M1 & M3) following administration of lomitapide alone and coadministered with atorvastatin 12 hours apart (Arm 2)|Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data. 3 subjects were removed from formal statistical analysis due to BLQ values on Day 1, missing value of AUC0-∞ on Day 1, and missing value of AUC0-∞ on Day 15.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2608230|NCT02080455|Secondary|AUC0-t|Area under the concentration-time curve from zero to the last quantifiable concentration of lomitapide and its 2 primary metabolites (M1 & M3) following administration of lomitapide alone and coadministered with atorvastatin 12 hours apart (Arm 2)|Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data. 1 subject was removed from formal statistical analysis due to all BLQ values on Day 1 for lomitapide, M1 and M3.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2608231|NCT02080455|Secondary|Tmax|Time to reach maximum observed plasma concentration of lomitapide and its 2 primary metabolites (M1 & M3) following administration of lomitapide alone and coadministered with atorvastatin 12 hours apart (Arm 2)|Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data. 1 subject was removed from formal statistical analysis due to all BLQ values on Day 1 for lomitapide, M1 and M3.|||hr||Full Range|Median
2608232|NCT02080455|Primary|t1/2|Apparent terminal elimination half-life of lomitapide and its 2 primary metabolites (M1 & M3), following administration of lomitapide alone and coadministered with atorvastatin simultaneously (Arm 1)|Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing|"The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data. 2 subjects were removed from formal statistical analysis of PK of M3 (Lomitapide alone) due to missing value of AUC0-∞ for Analyte M3."|||hr||Geometric Coefficient of Variation|Geometric Mean
2608233|NCT02080455|Primary|AUC0-∞|Area under the concentration-time curve from zero to infinity of lomitapide and its 2 primary metabolites (M1 & M3), following administration of lomitapide alone and coadministered with atorvastatin simultaneously (Arm 1)|Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing|"The PK Population consisted of all subjects who received at least one dose of study drug and had evaluable PK data. 2 subjects were removed from formal statistical analysis of PK of M3 (Lomitapide alone) due to missing value of AUC0-∞ for Analyte M3."|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2608234|NCT02080455|Secondary|Cmax|Maximum observed plasma concentration of lomitapide and its 2 primary metabolites (M1 & M3) following administration of lomitapide alone and coadministered with atorvastatin 12 hours apart (Arm 2)|Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data. 1 subject was removed from formal statistical analysis due to all BLQ values on Day 1 for lomitapide, M1 and M3.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2608235|NCT02080455|Primary|AUC0-t|Area under the concentration-time curve from zero to the last quantifiable concentration of lomitapide and its 2 primary metabolites (M1 & M3), following administration of lomitapide alone and coadministered with atorvastatin simultaneously (Arm 1)|Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK Population consisted of all subjects who received at least one dose of study drug and had evaluable PK data.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2608236|NCT02080455|Primary|Tmax|Time to reach maximum observed plasma concentration of lomitapide and its 2 primary metabolites (M1 & M3), following administration of lomitapide alone and coadministered with atorvastatin simultaneously (Arm 1)|Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK Population consisted of all subjects who received at least one dose of study drug and had evaluable PK data.|||hr||Full Range|Median
2608237|NCT02080455|Primary|Cmax|Maximum observed plasma concentration of lomitapide and its 2 primary metabolites (M1 & M3), following administration of lomitapide alone and coadministered with atorvastatin simultaneously (Arm 1)|Predose and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK Population consisted of all subjects who received at least one dose of study drug and have evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2608238|NCT02080312|Secondary|Extension of Contrast From Perilymph to CSF|The fundus of the internal auditory canal (IAC) was visually inspected to determine if there was conspicuous, subtle, or no enhancement extending in the setting of prior IT contrast injection, indicating permeability of the cochlear modiolus.|24 hours post injection||||participants|||Number
2608239|NCT02080312|Primary|"Cochlear Endolymphatic Hydrops (EH)"|The relative volume of the scala media of the basal turn of the cochlea (non-enhancing endolymph) was visually assessed relative to the scala tympani and scala vestibuli (enhancing perilymph) on delayed post-IT contrast FLAIR MRI sequences. Cases were characterized as: No Cochlear EH (no perceptible distention of the scala media), Cochlear EH (perceptible distention of the scala media), or Absent enhancement (no contrast in the cochlear perilymph)|24 hours post injection||||participants|||Number
2608240|NCT02080312|Primary|"Vestibular Endolymphatic Hydrops (EH)"|The relative volume of the non-enhancing endolymphatic space was visually assessed relative to the enhancing perilymphatic space on delayed post-IT contrast FLAIR MRI sequences and characterized as <34%, 34-50% or >50% of endolymphatic/perilymphatic volume.|24 hours post injection||||participants|||Number
2608241|NCT02080273|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|6 months post treatment use||||units on a scale||Standard Deviation|Mean
2608242|NCT02080273|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|3 months post treatment use||||units on a scale||Standard Deviation|Mean
2608243|NCT02080273|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|3 weeks post treatment use||||units on a scale||Standard Deviation|Mean
2608244|NCT02080273|Primary|Gingivitis Scores|Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)|baseline||||units on a scale||Standard Deviation|Mean
2608245|NCT02080273|Primary|Dental Plaque Score|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|6 months post treatment use||||units on a scale||Standard Deviation|Mean
2608246|NCT02080273|Primary|Dental Plaque Score|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|3 months post treatment use||||units on a scale||Standard Deviation|Mean
2608247|NCT02080273|Primary|Dental Plaque Score|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|3 weeks post treatment use||||units on a scale||Standard Deviation|Mean
2608248|NCT02080273|Primary|Dental Plaque Score|Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)|baseline||||units on a scale||Standard Deviation|Mean
2608249|NCT02080260|Secondary|Disease Control|Disease control will be determined for each patient as a binary variable indicating whether or not the patient achieved a best overall best response of CR, PR, or stable disease as determined by RECIST v1.1 criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.1): Complete Response (CR) is the disappearance of all lesions (target and non target); Partial Response (PR) is at least 30% decrease in the sum of the diameters of target lesions from baseline and no new lesions or unequivocal progression in non target lesions from baseline; Stable Disease (SD) is neither sufficient shrinkage in target lesions to qualify for PR (less than 30% decrease) nor sufficient increase in target lesions (versus smallest sum of diameters) to qualify for PD (less than 20% increase), with no new lesions or unequivocal progression in non target lesions from baseline.|From enrollment to best response while on regorafenib; Subjects remained on treatment until disease progression or death or discontinuation from study or at least 28 days after last dose (subjects were on treatment for an average of 6 weeks)|Efficacy analyses were conducted on the population of subjects who began regorafenib treatment|||Participants|||Count of Participants
2608250|NCT02080260|Secondary|Overall Response|Overall response will be determined as the best treatment response for each patient as a binary variable indicating whether or not the patient achieved a Complete Response (CR) or Partial Response (PR) as determined by RECIST v1.1 criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1):Complete Response (CR) is the disappearance of all lesions (target and non target); Partial Response (PR) is at least 30% decrease in the sum of the diameters of target lesions from baseline and no new lesions or unequivocal progression in non target lesions from baseline; Stable Disease (SD) is neither sufficient shrinkage in target lesions to qualify for PR (less than 30% decrease) nor sufficient increase in target lesions (versus smallest sum of diameters) to qualify for PD (less than 20% increase), with no new lesions or unequivocal progression in non target lesions from baseline. For the purposes of response determination, confirmatory scan for CR and PR is not required.|From enrollment to best response while on regorafenib; Subjects remained on treatment until disease progression or death or discontinuation from study or at least 28 days after last dose (subjects were on treatment for an average of 6 weeks)|Efficacy analyses were conducted on the population of subjects who began regorafenib treatment. Analysis of overall response rate was conducted on those patients in the efficacy population with measurable disease present at baseline.|||Participants|||Count of Participants
2608251|NCT02080260|Secondary|Overall Survival|Overall survival is defined as the duration from enrollment date to the date of death from any cause. Subjects who are alive or lost to follow-up at the time of the analysis will be censored at the last known date they were alive.|From date of treatment start to date of death, or censored as described above; assessed for approximately 3 years.|Efficacy analyses were conducted on the population of subjects who began regorafenib treatment|||weeks||95% Confidence Interval|Median
2608252|NCT02080260|Secondary|Progression Free Survival|PFS is defined as duration of time from enrollment to the study to time of progression or death. Disease progression (PD) can be objectively determined as per RECIST v1.1 (Response Evaluation Criteria in Solid Tumors, where PD is defined as a 20% increase in the sum of the longest diseased of target lesions, or a measurable increase in non-target lesion, or the appearance of new lesions) or progression can be subjective as determined by the investigator. Evidence for subjective progressions must be documented in medical records. For surviving subjects who do not have documented PD, PFS will be censored at last radiologic assessment. For subjects who receive subsequent anti-cancer therapy prior to documented PD, PFS will be censored at last radiologic assessment prior to commencement of subsequent therapy. Subjects who experience a PFS event following an interval equal to two or more scheduled CT assessments will be censored at date of last assessment prior to first missed assessment.|From date of treatment start to date of progression or death, or censored as described above; assessed for approximately 3 years.|Efficacy analyses were conducted on the population of subjects who began regorafenib treatment|||weeks||95% Confidence Interval|Median
2608253|NCT02080260|Primary|Number of Patients Progression Free and Surviving at 16 Weeks as a Percent of All Enrolled Subjects|16-week progression free survival was determined for each subject as a binary variable indicating whether or not the subject is alive and progression free at 16 weeks after treatment start, with progression defined radiographically using RECIST v1.1 or clinically based upon investigator assessment.|16 weeks after enrollment|Efficacy analyses were conducted on the population of subjects who began regorafenib treatment|||Participants|||Count of Participants
2608254|NCT02080195|Secondary|Chronic Graft Versus Host Disease (GVHD)|"Percentage of participants who developed chronic GVHD as defined by the NIH consensus criteria. This system gives scores from 0 to 3 for Karnofsky performance score, skin, mouth, eyes, gastrointestinal, liver, lungs, joints, and genitals, as well as an overall severity (mild, moderate, or severe).~Mild chronic GVHD involves only 1 or 2 organs or sites (except the lung), with no clinically significant functional impairment (maximum of score 1 in all affected organs or sites).~Moderate chronic GVHD involves 1) at least 1 organ or site with clinically significant but no major disability (maximum score of 2 in any affected organ or site) OR 2) 3 or more organs or sites with no clinically significant functional impairment (maximum score of 1 in all affected organs or sites).~Severe chronic GVHD indicates major disability caused by chronic GVHD (score of 3 in any organ or site)."|Up to 2 years||||Participants|||Count of Participants
2608255|NCT02080195|Secondary|Acute Graft Versus Host Disease (GVHD)|Percentage of participants who developed grades II-IV and grades III-IV acute GVHD. Acute GVHD is defined by the Przepiorka criteria, which stages the degree of organ involvement in the skin, liver, and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least severe and stage 4+ being the most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, Liver 4+).|Up to 2 years||||Participants|||Count of Participants
2608256|NCT02080195|Secondary|Graft Failure|Number of participants with primary and/or secondary graft failure.|60 days||||Participants|||Count of Participants
2608257|NCT02080195|Secondary|Survival|Number of patients alive and alive without relapse, respectively.|1 year||||Participants|||Count of Participants
2608258|NCT02080195|Secondary|RIFLE Score|"Change in Responder Index for Systemic Lupus Erythematosis (RIFLE) assessment. This is a qualitative assessment of organ function. The 12 month response will be assessed as:~complete= complete or partial resolution in more than one organ, partial= complete or partial resolution in at least one organ, the same= no change or no worsening in any organ, worse= worsening in any organ"|1 year|The only enrolled participant on this study was never assessed for a follow-up RIFLE scale, so no data was collected for this outcome measure.||||||
2608259|NCT02080195|Primary|The Feasibility of the Conditioning Regimen and Post Transplantation Cyclophosphamide in Refractory SLE Patients With Donors Having Various Degrees of Matching|Number of participants who were alive at 1 year after transplant and who had not suffered graft rejection, acute or chronic GVHD, or Grade 3 or higher (CTCAE V4.0) adverse events.|1 year||||Participants|||Count of Participants
2608260|NCT02080091|Secondary|Retinal Center Subfield Thickness|Observed and change from baseline SD-OCT values will be summarized using descriptive statistics.|24 months|23 Patients received ILUVIEN, one patient was treated bilaterally|||microns|Participants|Standard Deviation|Mean
2608261|NCT02080091|Primary|Number of Patients With Ocular Adverse Events||24 Months|23 Patients received ILUVIEN, one patient was treated bilaterally|||participants|Participants||Number
2608262|NCT02080091|Primary|Visual Acuity|Observed and change from baseline visual acuity LogMAR scores will be summarized using descriptive statistics.|24 Months|23 Patients received ILUVIEN, one patient was treated bilaterally|||LogMAR|Participants|Standard Error|Mean
2608263|NCT02079987|Primary|Number of Participants With In-patient Admission Claims|This outcome was determined by assessing the number of participants who had one or more Medicare claims for a hospitalization in the 30 days after the index ED visit.|Within 30 days after index ED visit|Participants with Medicare Claims available at least 30 days after the index ED visit are included in the analysis.|||Participants|||Count of Participants
2608264|NCT02079987|Primary|Number of Participants With ED Visit Claims|This outcome was determined by assessing the number of participants who had one or more Medicare claims for an ED visit in the 30 days after the index ED visit.|Within 30 days after index ED visit|Participants with Medicare Claims available at least 30 days after the index ED visit are included in the analysis.|||Participants|||Count of Participants
2608265|NCT02079987|Primary|Number of Participants With Outpatient Visit Claims|This outcome was determined by assessing the number of participants who had one or more Medicare claims for an outpatient visit in the 30 days after the index ED visit.|Within 30 days after index ED visit|Participants with Medicare Claims available at least 30 days after the index ED visit are included in the analysis.|||Participants|||Count of Participants
2608266|NCT02079987|Primary|Change in Informational Support Between Baseline and 60 Days Post-ED Visit|PROMIS Informational Support instruments measure perceived availability of helpful information or advice. Each of 5-items in the Informational Support Instrument used in this study has five response items ranging in value from one to five. Thus, the minimum score for the Informational Support Instrument used is 5 and the maximum score is 25. The raw score is translated to a T-score using PROMIS conversion tables. The T-score rescales the raw score into a standardized score with a mean of 50 and standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Informational Support, a T-score of 60 is one SD better than average and a T-score of 40 is one SD worse than average.|Baseline up to 60 days after index ED Visit|Only participants who completed the baseline ED and follow-up telephone quality of life surveys were analyzed for this primary outcome measure.|||T-score||Standard Error|Mean
2608267|NCT02079987|Primary|Change in Anxiety Between Baseline and 60 Days Post-ED Visit|PROMIS Anxiety instruments measure self-reported fear, anxious misery, and hyperarousal. Each of 8-items in the Anxiety Instrument used in this study has five response items ranging in value from one to five. Thus, the minimum score for the Anxiety Instrument used is 8 and the maximum score is 40. The raw score is translated to a T-score using PROMIS conversion tables. The T-score rescales the raw score into a standardized score with a mean of 50 and standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like Anxiety, a T-score of 60 is one SD worse than average and an Anxiety T-score of 40 is one SD better than average.|Baseline up to 60 days after index ED Visit|Only participants who completed the baseline ED and follow-up telephone quality of life surveys were analyzed for this primary outcome measure.|||T-score||Standard Error|Mean
2608268|NCT02079987|Primary|Change in Physical Function Between Baseline and 60 Days Post-ED Visit|PROMIS Physical Function instruments measure self-reported capability. Each of 7-items in the physical function instrument used in this study has five response items ranging in value from one to five. Thus, the minimum score for the Physical Function Instrument used is 7 and the maximum score is 35. The raw score is translated to a T-score using PROMIS conversion tables. The T-score rescales the raw score into a standardized score with a mean of 50 and standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Function, a T-score of 60 is one SD better than average. A Physical Function T-score of 40 is one SD worse than average. Change in Physical Function is the difference between baseline and 60 day T-score.|Baseline up to 60 days after index ED Visit|Only study participants who completed the baseline ED and follow-up telephone quality of life surveys were analyzed for this primary outcome measure|||T-score||Standard Error|Mean
2608269|NCT02079909|Secondary|ADCS-ADL Change From Baseline to Week 52|The ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) is a validated tool for assessing instrumental and basic activities of daily living based on a 23-item structured interview of the study partner. The scale has a range of 0 to 78, with lower scores indicating greater impairment.|Baseline and 52 weeks|The overall number of participants display the numbers of patients who were included in the mITT population and had baseline and at least one post-baseline ADCS-ADL evaluation.|||units on a scale||Standard Error|Mean
2608270|NCT02079909|Primary|CGIC|The ADCS-CGIC (Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change) is a validated categorical measure of change in the patient's clinical condition between baseline and follow-up visits. It measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a clinical interview and examination. It relies on both direct examination of the patient and an interview of the study partner. A skilled and experienced clinician who is blinded to treatment assignment rates the patient on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). It is suggested that the instrument has distinct clinical utility in assessing change in AD clinical trials.|52 weeks|The overall number of participants display the numbers of patients who were included in the mITT population and had at least one post-baseline CGIC evaluation.|||units on a scale||Standard Error|Mean
2608271|NCT02079909|Primary|ADAS-cog Change From Baseline to Week 52|The ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) is a structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions are also obtained. The test is scored in terms of errors, with higher scores reflecting poorer performance and greater impairment. Scores can range from 0 (best) to 70 (worse).|Baseline and 52 weeks|The overall number of participants display the numbers of patients who were included in the mITT population and had baseline and at least one post-baseline ADAS-cog evaluation.|||units on a scale||Standard Error|Mean
2608272|NCT02079844|Secondary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurement|Vital signs were oral body temperature, respiration rate, supine blood pressure (after 5 minutes resting), and pulse rate.|From Day 1 until Day 63|Safety population, including all randomized participants who received at least 1 dose of study drug and completed the vital sign tests on Day 8 of each treatment period.|||percentage of participants|||Number
2608273|NCT02079844|Secondary|Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests|Percentage of participants with markedly abnormal safety laboratory tests (Hematology, Serum Chemistry and Urinalysis) collected throughout the study.|From Day 1 until Day 63|Safety population, including all randomized participants who received at least 1 dose of study drug and completed the laboratory tests during treatment.|||percentage of participants|||Number
2608274|NCT02079844|Secondary|Percentage of Participants Who Experience at Least 1 Treatment-Emergent Adverse Event|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|From Day 1 until Day 63|Safety population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2608741|NCT02074553|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib|Tmax is the time from alectinib administration to reach Cmax for alectinib.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||hours||Full Range|Median
2608275|NCT02079844|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score|PANSS assesses the positive symptoms, negative symptoms, and general psychopathology associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Positive subscale consists of 7 items which assesses the positive symptoms with subscale score ranging from 7 to 49, where higher score indicates greater severity. Negative subscale consists of 7 items which assesses the negative symptoms with subscale score ranging from 7 to 49, where higher score indicates greater severity. General psychopathology subscale consists of 16 items which assesses the general symptoms of schizophrenia with subscale score ranging from 16 to 96, where higher score indicates greater severity. A negative change from Baseline indicates improvement. ANOVA with treatment sequence, study period and treatment group as fixed effects and participant nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.|||score on a scale||Standard Error|Least Squares Mean
2608276|NCT02079844|Secondary|Change From Baseline in Frontal Theta Power (EEG) During N-Back Working Memory Task|EEG, a test that measures brain electrical activity, was performed during the n-back task. In the n-back task participants are required to monitor a series of letters and report when the current letter matches the letter n integers back, where n=1 (1-back) or n=2 (2-back), the latter requiring a greater working memory resources. The task requires continuous updating of information stores. In the 0-back condition (which does not require manipulation of material in working memory), participants respond to the appearance of a pre-specified letter. The task consists of alternating 30-second (s) blocks of 0-back with 1-back, and 2-back conditions, with letters displayed every 2 s for 1 s within each block. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.|||μV||Standard Error|Least Squares Mean
2608277|NCT02079844|Secondary|Change From Baseline in High Beta/Low Gamma Power During Resting EEG|Participants are asked to open and close their eyes in 30 second alternating blocks to maintain an approximately constant level of arousal. The eyes closed EEG, a test that measures brain electrical activity, is dominated by alpha (8-14Hz) and the eyes open EEG dominated by beta (14-30Hz eyes open) with the two states analyzed separately to increase sensitivity to drug effects in these bands. Ratio is calculated as High Beta/Low Gamma Power. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.|||ratio||Standard Error|Least Squares Mean
2608278|NCT02079844|Secondary|Change From Baseline in Amplitude of the C1 Component of the Visual Evoked Potentials at the Midline Occipital Electrode (Oz)|EEG, a test that measures brain electrical activity was used. Participants had a baseline Visual Evoked Potentials (VEP) recording (2 minute checkerboard VEP) followed by a period of high frequency stimulation (2 minutes 9 Hz checkerboard stimulation). The VEP was repeated 2 minutes after the end of high frequency stimulation. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.|||μV||Standard Error|Least Squares Mean
2608279|NCT02079844|Secondary|Change From Baseline in Mismatch Negativity (MMN) Amplitude at the Midline Frontal Electrode (Fz)|EEG, a test that measures brain electrical activity was performed during the MMN. The MMN is an auditory event related potential that is elicited by any discriminable change in auditory stimulation irrespective of the participant or participant's attention. The response to stimuli is being recorded by EEG electrodes while participants read a book. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.|||μV||Standard Error|Least Squares Mean
2608280|NCT02079844|Secondary|Change From Baseline in P300 Amplitude at the Midline Parietal Electrode (Pz)|"Brain electrical activity changes were quantified with electroencephalogram (EEG) battery tests. The P300 occurs after the presentation of a novel, behaviorally relevant target stimulus embedded among irrelevant stimuli. It reflects allocation of attention and activation of immediate memory.~The amplitude of P300 indexes brain actions when the mental representation of the stimulus environment is updated, while its latency indexes stimulus classification speed unrelated to response selection processes. The participants are instructed to push a button when hearing the target stimulus, but not when hearing the standard. They are asked to press the button as fast as possible. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis."|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis at Baseline and Day 8.|||microvolts (μV)||Standard Error|Least Squares Mean
2608298|NCT02079610|Secondary|Change From Baseline Hamilton Rating Scale for Depression at 2 Weeks|"Depression symptom severity rating scale. The overall score ranges on HDRS are from from 0 to 50, with higher scores indicating more severe depression. Usual cutoff points are:~0 to 7 - normal /symptom absent 8 to 16 - mild depression 17 to 23 - moderate depression >24 - severe depression"|baseline and 2 weeks|One participant in each group did not complete all study visits|||units on a scale||Standard Deviation|Mean
2608281|NCT02079844|Secondary|Ventral Striatum Activation During the Reward Trials|"BOLD fMRI, a test that measures brain activity, was used during the Reward Task (Monetary Incentive Delay Test). Participants were instructed to respond as quickly as possible to a light-flash on the display screen. The flash was preceded by an arrow icon that informed participants about the consequences of their response to the flash stimulus. Four conditions were included in the paradigm, as follows:~Win condition (arrow up): win 2 pound sterling if the response was sufficiently fast.~Avoidance of loss condition (arrow down: lose 2 pound sterling if the response was too slow.~Verbal control (vertical double arrow): no gain or loss of money.~Passive control condition (horizontal double arrow): No response was required. Each of the above conditions was presented at least 10 times in a random order. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect was used for analysis."|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.|||unitless parameter estimates||Standard Error|Least Squares Mean
2608282|NCT02079844|Secondary|Ventrolateral Prefrontal (VLPF) Cortex and Orbitofrontal (OFX) Cortex Activation During the Shift Trials|BOLD fMRI, a test that measures brain activity, was used during the Shifting Task at VLPF and OFX. Participants worked out which pair in a stimulus set consisting of a face and a building; transparent and overlapping, was the target. 1 pair appeared on the left of the screen, the other on the right. In each trial, participants indicated using a button box which side of the screen they thought the target was located on. Every second response, feedback was presented on the screen for 0.6 seconds, indicating whether or not the stimulus chosen was the target. If both of the last 2 choices were correct, the feedback was the word ''correct'' in green; otherwise, the feedback was the word ''incorrect'' in red. After 3 positive feedback events, a change of target occurred. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.|||unitless parameter estimates||Standard Error|Least Squares Mean
2608283|NCT02079844|Secondary|Change From Baseline in Category Fluency Animal Naming Scores|The Category Fluency test assesses the participant's speed of processing. The test is administered orally, with the participant naming as many animals as he can in 1 minute. The key outcome variable for the test is the total number of correct, valid category words in 60 seconds. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.|||correct words||Standard Error|Least Squares Mean
2608284|NCT02079844|Secondary|Change From Baseline in Brief Assessment of Cognition in Schizophrenia: Symbol-Coding|The Brief Assessment of Cognition in Schizophrenia (BACS): Symbol-Coding assesses the participant's speed of processing. The test is a timed paper-and-pencil test in which the participant uses a key to write digits that correspond to nonsense symbols. The key outcome variable for this task is the total number of correct, valid symbols in 90 seconds. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period and treatment group as fixed effects and participant nested within treatment sequence as a random effect.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.|||correct symbols||Standard Error|Least Squares Mean
2608285|NCT02079844|Secondary|Change From Baseline in the Continuous Performance Test (CPT)|The CPT is a computerized test that assesses the participant's attention and vigilance. The participant was asked to attend to digits flashing on a computer screen and to click the mouse when the same string of digits flashed consecutively. The test consisted of 3 trials: the first contained 2-digit sequences, the second contained 3-digit sequences, and the third contained 4-digit sequences. Scoring was based the number of correct hits. The total score was an average of the 3 trials. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and subject nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.|||correct hits||Standard Error|Least Squares Mean
2608286|NCT02079844|Primary|Dorsolateral Prefrontal Cortex Activation During the Rewarded Delayed Response Working Memory|BOLD Functional magnetic resonance imaging (fMRI) changes in the blood-oxygen-level-dependent (BOLD) - signal, which changes in response to neural activity. Baseline fMRI measurements will be followed by rewarded delayed response Working Memory (WM) task measurements in which participants are required to remember the spatial location of a target stimulus (a dot) relative to a fixation cross. Participants are given feedback indicating success or failure. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available for analysis.|||unitless parameter estimates||Standard Error|Least Squares Mean
2608299|NCT02079610|Secondary|Change From Baseline Beck Depression Inventory at 2 Weeks|"Depression symptom severity rating scale. The overall score ranges on BDI are from from 0 to 63, with higher scores indicating more severe depression. Usual cutoff points are:~0 to 13 - normal /symptom absent 14 to 19 - mild depression 20 to 28 - moderate depression >29 - severe depression"|baseline and 2 weeks|One participant in each group did not complete all study visits|||units on a scale||Standard Deviation|Mean
2608416|NCT02078713|Secondary|Shared Decision Making - Satisfaction With How Provider Helped With Choice|Patient report of satisfaction on a 5-point Likert scale (from 1=completely unsatisfied to 5=completely satisfied) of how the provider helped contraceptive method choice. Analyzed dichotomously as top score of 5 versus <5.|Baseline (post-visit survey)|Observed in patients only|||Participants|||Count of Participants
2608287|NCT02079844|Primary|Change From Baseline in Hopkins Verbal Learning Test (HVLT) Score|The HVLT assesses the participant's verbal learning. The test consists of a list of 12 words from three taxonomic categories which are presented orally, and the participant is asked to recall as many as possible after each of three learning trials. The key outcome variable for this task is the total correct responses in the three learning trials. A positive change from Baseline indicates improvement. ANOVA with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available at both Baseline and Day 8 for analysis.|||correct responses||Standard Error|Least Squares Mean
2608288|NCT02079844|Primary|Change From Baseline in Spatial Span Test Score|The Spatial Span test assesses the participant's working memory. During this task, participants are presented with a board containing blue blocks randomly arranged. The rater first taps out a pattern of blocks, beginning with two blocks and increasing with participant proficiency, and the participant is tasked with tapping the same pattern. After discontinuation of this part of the subtest, the participant is then tasked with tapping out the reverse pattern after the rater's demonstration. These patterns also begin with two blocks and increase with participant proficiency. The total score for this subtest ranges from 0 (worst) to 32 (best). A positive change from Baseline indicates improvement. Analysis of Variance (ANOVA) with treatment sequence, study period, and treatment as fixed effects and participant nested within treatment sequence as a random effect was used for analysis.|Baseline and Day 8 of Treatment Periods 1, 2 and 3|Participants from the Pharmacodynamic Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least 1 pharmacodynamic result post-dose, with data available at both Baseline and Day 8 for analysis.|||score on a scale||Standard Error|Least Squares Mean
2608289|NCT02079805|Secondary|Number of Participants With Treatment-Emergent Adverse Events||Up to Week 12|The safety analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||participants|||Number
2608290|NCT02079805|Secondary|Change in 1,5-anhydroglucitol (1,5-AG) From Baseline at the End of the Treatment Period (Week 12)|Change from baseline in 1,5-G concentration collected at week 12 or final visit relative to baseline was reported.|Baseline and Week 12|The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||μg/mL||Standard Deviation|Mean
2608291|NCT02079805|Secondary|Change in Homeostasis Model Assessment of Beta Cell Function (HOMA-β) From Baseline at the End of the Treatment Period (Week 12)|Change from baseline in HOMA-β collected at week 12 or final visit relative to baseline was reported. Homeostasis model assessment of beta cell function measures as following; HOMA-β = fasting insulin (μU/mL) ×360/{fasting glucose (mg/dL) - 63}.|Baseline and Week 12|The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||percent||Standard Deviation|Mean
2608292|NCT02079805|Secondary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline at the End of the Treatment Period (Week 12)|Change from baseline in the values of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit relative to baseline was reported.|Baseline and Week 12|The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||percent||Standard Deviation|Mean
2608293|NCT02079805|Secondary|Change in Fasting Insulin From Baseline at the End of the Treatment Period (Week 12)|Change from baseline in fasting insulin values collected at week 12 or final visit relative to baseline was reported.|Baseline and Week 12|The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||µU/mL||Standard Deviation|Mean
2608294|NCT02079805|Secondary|Change in Fasting Blood Glucose From Baseline at the End of the Treatment Period (Week 12)|Change from baseline in fasting blood glucose values collected at week 12 or final visit relative to baseline was reported.|Baseline and Week 12|The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||mg/dL||Standard Deviation|Mean
2608295|NCT02079805|Primary|Change in Insulin Resistance Index (HOMA-R) From Baseline at the End of the Treatment Period (Week 12)|Change from the start of the treatment period (baseline) at the end of the treatment period (Week 12) was reported. Insulin Resistance Index (HOMA-R) measures insulin resistance, calculated by fasting insulin (μU/mL) multiplied by fasting glucose (mg/dL), and divided by a constant (405).|Baseline and Week 12|The full analysis set was defined as the participants who received at least 1 dose of the study drug for the treatment period.|||HOMA-R Score||Standard Deviation|Mean
2608296|NCT02079649|Secondary|Mean Change From Baseline in Ocular Itching, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7|Ocular itching was assessed by the subject with both eyes rated together and scored on a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub). AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)[Day 7] - AUC(0-10) [Baseline].|0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7|This analysis population includes all randomized subjects who had a baseline evaluation minus those who had important protocol deviations that could have affected the outcome of the study.|||hours x units on a scale||Standard Error|Mean
2608297|NCT02079649|Primary|Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7|Ocular redness ratings were collected for nasal and temporal areas of each eye and assessed by investigational center staff using a visual scale (ie, scored by comparing the subject's eye with a series of photographs) and graded on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)[Day 7] - AUC(0-10) [Baseline]. Both eyes contributed to the analysis.|0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7|This analysis population includes all randomized subjects who had a baseline evaluation minus those who had important protocol deviations that could have affected the outcome of the study.|||hours x units on a scale||Standard Error|Mean
2608300|NCT02079610|Primary|Change From Baseline in Montgomery Asberg Depression Rating Scale at 2 Weeks|"Depression symptom severity rating scale. The overall score ranges on MADRS are from from 0 to 60, with higher scores indicating more severe depression. Usual cutoff points are:~0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression"|baseline and 2 weeks|1 participant in each group did not complete all study visits|||units on a scale||Standard Deviation|Mean
2608301|NCT02079532|Secondary|Rheumatoid Factor (RF)|Mean RF as measured by international unit per milliliter (IU/mL) at screening and Weeks 8, 16, and 24.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||IU/mL||Standard Deviation|Mean
2608302|NCT02079532|Secondary|Erythrocyte Sedimentation Rate (ESR)|Mean ESR, as an acute phase reactant, measured in mm/hr at screening, Days 1 and 15, and Weeks 8, 16, and 24.|Screening, Days 1 and 15, and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||mm/hr||Standard Deviation|Mean
2608303|NCT02079532|Secondary|C-Reactive Protein (CRP)|Mean CRP as measured as an acute phase reactant by mg per deciliter (mg/dL) at screening, Days 1 and 15, and Weeks 8, 16, and 24.|Screening, Days 1 and 15, and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||mg/dL||Standard Deviation|Mean
2608304|NCT02079532|Secondary|Patient's Assessment of Pain|"Participants were to assess their current level of pain on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no pain and the right-hand (100 mm) as unbearable pain."|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||mm||Standard Deviation|Mean
2608305|NCT02079532|Secondary|Patient's Assessment of Disease Activity|"Participants were to assess the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as maximum disease activity (maximum arthritis disease activity)."|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||mm||Standard Deviation|Mean
2608306|NCT02079532|Secondary|Physician's Global Assessment of Disease Activity|"Physicians assessed the disease (RA) activity on a 100 mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right hand extreme (100 mm) as maximum disease activity (maximum arthritis disease activity)."|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||mm||Standard Deviation|Mean
2608307|NCT02079532|Secondary|Tender Joint Count (TJC)|The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||tender joints||Standard Deviation|Mean
2608308|NCT02079532|Secondary|Swollen Joint Count (SJC)|The 28 joints to be assessed for tenderness and swelling were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||swollen joints||Standard Deviation|Mean
2608309|NCT02079532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Response (ACR20/ACR50/ACR70)|ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in tender or swollen joint counts and ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the following 5 criteria: 1) Physician's Global Assessment of Disease Activity, 2) Patient's Global Assessment of Disease Activity, 3) Patient's Assessment of Pain, 4) participant assessment of functional disability via a HAQ-DI, and 5) C-reactive protein or ESR at each visit.|Weeks 8, 16, and 24|ITT population|||percentage of participants|||Number
2608310|NCT02079532|Secondary|SF-36 Domain Scores|The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to two distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||scores on a scale||Standard Deviation|Mean
2608311|NCT02079532|Secondary|Short-Form 36 (SF-36) Physical Composite Scores (PCS) and Mental Composite Scores (MCS)|The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the physical and mental composite t-scores (PCS and MCS). The range for all 8 domains as well as for the composite t-scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||scores on a scale||Standard Deviation|Mean
2608312|NCT02079532|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score|The FACIT fatigue scale is base on a 13-item questionnaire to assess the therapy-induced fatigue. Participants were requested to score each question on a scale ranging from 0 (best) to 4 (worst). The scoring system of the FACIT fatigue scale adds up to a total scale ranging from 0 (best) to 52 (worst). The assessment was originally developed for chronic illnesses and is now validated for patients with rheumatoid arthritis (RA). The questionnaire was provided in a German translation.|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||scores on a scale||Standard Deviation|Mean
2608742|NCT02074553|Primary|Maximum Observed Plasma Concentration (Cmax) of Alectinib|Cmax is the maximum observed plasma alectinib concentration, presented in nanogram per milliliter (ng/mL).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||ng/mL||Standard Deviation|Mean
2608313|NCT02079532|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. For each of the categories, participants reported the amount of difficulty they had in performing 2 or 3 specific sub-category items. The standard disability score was calculated from the 8 categories by dividing the sum of the individual categories by the number of categories answered, yielding a score from 0 (without any difficulty) to 3 (unable to do).|Screening and Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit.|||scores on a scale||Standard Deviation|Mean
2608314|NCT02079532|Secondary|Percentage of Participants Achieving a Response By EULAR Category|Percentage of participants achieving a response by EULAR category, including 'moderate', 'good', or no response at follow-up Weeks 8, 16, and 24. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤ 3.2; moderate responders had a change from baseline >1.2 with a DAS28 score of >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders had a change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with a DAS28 score of >5.1.|Weeks 8, 16, and 24|ITT population|||percentage of participants|||Number
2608315|NCT02079532|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.6) at Week 24|Percentage of participants with remission defined as DAS28 <2.6 at follow-up Week 24. The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient's Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Week 24|ITT population|||percentage of participants|||Number
2608316|NCT02079532|Secondary|Percentage of Participants With Low Disease Activity (DAS28 ≤3.2) at Week 24|Percentage of participants with low disease activity defined as DAS28 ≤3.2 at follow-up Week 24. The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient's Global Assessment of Disease Activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).|Week 24|ITT population|||percentage of participants|||Number
2608317|NCT02079532|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response of Good or Moderate|The DAS28-based EULAR response criteria were used to measure individual responses as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders experienced a change from baseline of >1.2 with a DAS28 score ≤3.2 and moderate responders experienced a change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or a change from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1.|Weeks 8, 16, and 24|ITT population; n=number of participants assessed at a given visit|||percentage of participants|||Number
2608318|NCT02079532|Secondary|DAS28 Score|The DAS28 consists of SJC and TJC measurements, the ESR in mm/hr, and the Patient's Global Assessment of Disease Activity (participant-rated RA assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Screening and Weeks 8, 16, and 24|ITT population; n (number) = number of participants assessed at a given visit.|||scores on a scale||Standard Deviation|Mean
2608319|NCT02079532|Primary|Change From Baseline to Week 24 in Disease Activity Score Based on 28-Joint Count (DAS28)|The DAS28 consists of swollen joint count (SJC) and tender joint count (TJC) measurements, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and the Patient's Global Assessment of Disease Activity (participant-ated rheumatoid arthritis [RA] activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Week 24|Intent to Treat (ITT) population: all participants who signed informed consent, received at least 1 dose of study drug, and where DAS28 was measured at least once under study medication (Weeks 8, 16, or 24 or unscheduled or withdrawal visit up to Week 24); those with no RA or no DAS28 score at screening were excluded, regardless if treated or not.|||scores on a scale||Standard Deviation|Mean
2608320|NCT02079519|Secondary|Overall Survival|Overall survival was defined as the time from the first dose of study medication until death.|Baseline to the end of the study (up to 1 year)|||||||
2608321|NCT02079519|Secondary|Progression-free Survival|Progression-free survival was defined as the time from the first dose of study drug to disease progression or death due to progression.|Baseline to the end of the study (up to 1 year)|||||||
2608322|NCT02079519|Primary|Percentage of Participants With a Complete Response or a Partial Response|A complete response was defined as the disappearance of the original monoclonal protein from the blood and urine on at least 2 determinations 6 weeks apart; < 5% plasma cells in the bone marrow on at least 2 determinations 6 weeks apart; if a skeletal survey is available, no increase in the size or number of lytic bone lesions; and the disappearance of soft tissue plasmacytomas for at least 6 weeks. A partial response was defined as a ≥ 50% reduction of monoclonal protein in the blood on at least 2 determinations 6 weeks apart; if present, reduction in 24-hour urinary light chain excretion by either ≥ 90% or to < 200 mg for at least 2 determinations 6 weeks apart; ≥ 50% reduction in the size of tissue plasmacytomas for at least 6 weeks; and if a skeletal survey is available, no increase in the size or number of lytic bone lesions.|Baseline to the end of the study (up to 1 year)|Intent-to-treat population: All participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2608323|NCT02079311|Primary|The Difference in Core Body Temperature in the Two Treatment Groups.|Temperature assessments will be made using an oesophageal temperature probe when the subject is under general anaesthesia and by oral thermometer for all other temperature assessments performed in pre-, intra- and post-op. The mean value is calculated on all temperature measured during pre-, intra- and post-op.|Subjects will be followed for one day of hospital stay, data to be collected during the perioperative phase. Expected to be between 5-8 hours.||||degree celsius||Standard Deviation|Mean
2608417|NCT02078713|Secondary|Shared Decision Making - Provider Appropriately Expressed Preference|Patient report of attitude on 3-point scale on how provider expressed preference for contraceptive method choice: Right amount, wish less strongly, wish more strongly.|Baseline (post-visit survey)|Observed in patients only|||Participants|||Count of Participants
2608324|NCT02079246|Secondary|Change in Cognitive Aspects of Mental Function|Change from Baseline III to Week 52 in Mini Mental State Examination (MMSE). The MMSE is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).|Baseline III (start of OLEX-MEM, Week 28) to Week 52|All patients who took at least one dose of IMP or memantine in the OLEX-MEM.|||units on a scale||Standard Error|Mean
2608325|NCT02079246|Secondary|Change in Cognitive Aspects of Mental Function|Change from Baseline II to Week 28 in Mini Mental State Examination (MMSE). The MMSE is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).|Baseline II (start of OLEX, Week 0) to Week 28|All patients in who took at least one dose of IMP in the OLEX.|||units on a scale||Standard Error|Mean
2608326|NCT02079246|Secondary|Change in Behavioural Disturbance|Change from Baseline II to Week 28 in Neuropsychiatric Inventory (NPI) total score. The NPI is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total NPI score is the frequency ratings multiplied by the severity ratings and ranges from 0 to 144 (higher score indicates worse outcome).|Baseline II (start of OLEX, Week 0) to Week 28|All patients in who took at least one dose of IMP in the OLEX.|||units on a scale||Standard Error|Mean
2608327|NCT02079246|Secondary|Change in Daily Functioning|Change from Baseline II to Week 28 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score. The ADCS-ADL23 is a 23-item clinician-rated inventory to assess activities of daily living (conducted with a caregiver or informant). Each item comprises a series of hierarchical sub-questions, ranging from the highest level of independent performance to a complete loss for each activity. Total score of the 23 items ranges from 0 to 78 (higher score indicates lower disability).|Baseline II (start of OLEX, Week 0) to Week 28|All patients in who took at least one dose of IMP in the OLEX.|||units on a scale||Standard Error|Mean
2608328|NCT02079246|Secondary|Clinical Global Impression Score|Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 28. The ADCS-CGIC is a semi-structured interview to assess clinically relevant changes in patients with AD. The items determine cognition, behavior, social and daily functioning. Severity at baseline is rated on a 7-point scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). The clinically relevant change from baseline is rated on a 7-point scale from 1 (marked improvement) to 7 (marked worsening).|Week 28|All patients in who took at least one dose of IMP in the OLEX.|||units on a scale||Standard Error|Mean
2608329|NCT02079246|Secondary|Change in Cognition|Change from Baseline II to Week 28 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) total score. The ADAS-cog is a 11-item neuropsychological test that assess the severity of cognitive impairment. The items determine the patient's orientation, memory, language, and praxis. Total score of the 11 items range from 0 to 70 (lower score indicates lower cognitive impairment).|Baseline II (start of OLEX, Week 0) to Week 28|All patients in who took at least one dose of IMP in the OLEX.|||units on a scale||Standard Error|Mean
2608330|NCT02079246|Primary|Number of TEAEs in the OLEX-MEM|A TEAE is an adverse event that starts or increases in intensity after the date of Baseline III (start of OLEX-MEM).|From Baseline III (start of OLEX-MEM, Week 28) to end of OLEX-MEM (Week 52)|All patients who took at least one dose of IMP or memantine in the OLEX-MEM.|||TEAEs|||Number
2608331|NCT02079246|Primary|Number of Treatment Emergent Adverse Events (TEAEs) in the OLEX|A TEAE is an adverse event that starts or increases in intensity after the date of Baseline II.|Baseline II (start of OLEX, week 0) to end of OLEX (week 28)|All patients who took at least one dose of IMP in the OLEX.|||TEAEs|||Number
2608332|NCT02079077|Secondary|Change in Number of CCR5+CD4+ T Cell Population at the Female Genital Tract.|We will measure changes in the number of CD4+T cells expressing CCR5 at the female genital tract before and at the end of the study.|baseline and 8 weeks||||percentage of cells||Standard Deviation|Median
2608333|NCT02079077|Primary|Changes in Systemic Immune Activation From Baseline Observed by the CD69 Expression on CD4 T Cells|We will analyse reduce of immune activation by measuring change in T cell activation (CD69) between baseline and every month during drug administration phase (8 weeks).|Baseline and 8 weeks|general population|||percentage of cells||Standard Deviation|Mean
2608334|NCT02079025|Secondary|Combined Sensitivity and Specificity in Determining Cancer Detection Overall for Image-guided Biopsy|Pathology analysis of prostate biopsy is reviewed. Sensitivity of targeted biopsy for each arm will be calculated as the number of targeted biopsy that also found cancer among all targeted biopsies. Specificity of targeted biopsy for each arm will be calculated as the number of non-targeted biopsies that find no cancer among all non-targeted biopsies. Interim analyses are planned beginning when 800 patients have been enrolled and after every additional 200 patients are enrolled up to the maximum sample size of 2000 patients.|First visit (a patient's involvement in the trial is complete following his biopsy).||||percentage of post-training samples|Post-training biopsy samples||Number
2608335|NCT02079025|Secondary|Improvement of an Investigator's Ability to Detect Clinically Significant Cancer Using UHR-TRUS Post-training When Compared to Pre-training|Comparison of pre- and post-training percentage of participants found to harbor clinically significant prostate cancer within the UHR-TRUS arm of the trial|Pre-training refers to all biopsy procedures occurring between initial training and mid-trial PRI-MUS training. Post-training refers to all biopsy procedures performed after mid-trial PRI-MUS training.|Pre and post-training detection rate for csPCa for the UHR-TRUS arm only (as investigators received additional training on this imaging modality)|||Percentage of subjects with csPCa|||Number
2608414|NCT02078713|Secondary|Shared Decision Making - Provider Preference|Patient report of whether or not provider had preference for contraceptive method choice, reported on a 5-point scale: no preference, slight preference, moderate preference, strong preference, extremely strong preference. Analyzed dichotomously as any preference versus no preference.|Baseline (post-visit survey)|Observed in patients only|||Participants|||Count of Participants
2608336|NCT02079025|Primary|Percentage of Participants With Clinically Significant Prostate Cancer|Pathology analysis of prostate biopsy is reviewed for indication of clinically significant prostate cancer. Interim analyses are planned beginning when 800 patients have been enrolled and after every additional 200 patients are enrolled up to the maximum sample size of 2000 patients.|First visit (a patient's involvement in the trial is complete following his biopsy).|Intent To Treat includes all subjects, Per Protocol includes only subjects without protocol deviations.|||percentage of participants with csPCa|||Number
2608337|NCT02078960|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product, regardless of whether it has a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is an AE that that began or worsened after treatment with study drug. Severity rating of 3=Severe or medically significant but not immediately life-threatening 4=Life-threatening consequences and 5=Death. Relation to study drug is determined by the investigator. A serious adverse event (SAE) includes death, a life-threatening AE, hospitalization, persistent or significant disability or incapacity, a congenital anomaly/birth defect, or any important medical event requiring immediate intervention to prevent one of the outcomes above.|Day 1 up to Month 15|Safety Analysis set|||Participants|||Count of Participants
2608338|NCT02078960|Secondary|Apparent Volume of Distribution (V/F) for Omacetaxine|Nominal PK sampling times were used.|Cycle 1 - Day 1 (predose, 15, 30, 45 minutes, 1, 2, 4, 8, 24, 48, 72 hours post-dose) Day 10 (predose, 2 samples postdose), Day 13 (predose) Cycles 2+3 - Day 1 (2 samples postdose), Days 10 and 17 (1 sample predose)|PK analysis set|||L||Standard Deviation|Mean
2608339|NCT02078960|Secondary|Total Oral Clearance (CL/F) for Omacetaxine|Nominal PK sampling times were used.|Cycle 1 - Day 1 (predose, 15, 30, 45 minutes, 1, 2, 4, 8, 24, 48, 72 hours post-dose) Day 10 (predose, 2 samples postdose), Day 13 (predose) Cycles 2+3 - Day 1 (2 samples postdose), Days 10 and 17 (1 sample predose)|PK analysis set|||L/hour||Standard Deviation|Mean
2608340|NCT02078960|Secondary|Terminal Elimination Half-Life (t1/2) for Omacetaxine|Nominal PK sampling times were used.|Cycle 1 - Day 1 (predose, 15, 30, 45 minutes, 1, 2, 4, 8, 24, 48, 72 hours post-dose) Day 10 (predose, 2 samples postdose), Day 13 (predose) Cycles 2+3 - Day 1 (2 samples postdose), Days 10 and 17 (1 sample predose)|PK analysis set|||hour||Standard Deviation|Mean
2608341|NCT02078960|Secondary|Area Under the Drug Concentration by Time Curve From Time 0 to Infinity (AUC0-inf) for Omacetaxine|Nominal PK sampling times were used.|Cycle 1 - Day 1 (predose, 15, 30, 45 minutes, 1, 2, 4, 8, 24, 48, 72 hours post-dose) Day 10 (predose, 2 samples postdose), Day 13 (predose) Cycles 2+3 - Day 1 (2 samples postdose), Days 10 and 17 (1 sample predose)|PK analysis set|||ng*hr/mL||Standard Deviation|Mean
2608342|NCT02078960|Secondary|Area Under the Drug Concentration by Time Curve From Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) for Omacetaxine|Nominal PK sampling times were used.|Cycle 1 - Day 1 (predose, 15, 30, 45 minutes, 1, 2, 4, 8, 24, 48, 72 hours post-dose) Day 10 (predose, 2 samples postdose), Day 13 (predose) Cycles 2+3 - Day 1 (2 samples postdose), Days 10 and 17 (1 sample predose)|PK analysis set|||ng*hr/mL||Standard Deviation|Mean
2608343|NCT02078960|Secondary|Time to Maximum Observed Plasma Concentration (Cmax) for Omacetaxine|Time to maximum observed plasma drug concentration (Cmax) by inspection (without interpolation). Nominal PK sampling times were used.|Cycle 1 - Day 1 (predose, 15, 30, 45 minutes, 1, 2, 4, 8, 24, 48, 72 hours post-dose) Day 10 (predose, 2 samples postdose), Day 13 (predose) Cycles 2+3 - Day 1 (2 samples postdose), Days 10 and 17 (1 sample predose)|PK analysis set|||hour||Full Range|Median
2608344|NCT02078960|Secondary|Maximum Observed Plasma Concentration (Cmax) for Omacetaxine|Maximum observed plasma drug concentration (Cmax) by inspection (without interpolation). Nominal PK sampling times were used.|Cycle 1 - Day 1 (predose, 15, 30, 45 minutes, 1, 2, 4, 8, 24, 48, 72 hours post-dose) Day 10 (predose, 2 samples postdose), Day 13 (predose) Cycles 2+3 - Day 1 (2 samples postdose), Days 10 and 17 (1 sample predose)|PK analysis set|||ng/mL||Standard Deviation|Mean
2608345|NCT02078960|Secondary|Number of Participants Who Were Alive at Study Termination|Overall survival was defined as the time interval from the date of the first dose to the date of death from any cause. Kaplan-Meier time estimates for overall survival were not performed due to the small enrollment population and early termination of the study. What is reported is the number of participants who were alive at the time of study termination.|Day 1 to Day 541 (longest progression/survival follow-up)|Enrolled participants|||Participants|||Count of Participants
2608346|NCT02078960|Secondary|Number of Participants Who Were Alive and Progression-Free at Study Termination|Progression-free survival was defined as the time interval from the date of first dose to the date of the earliest objective evidence of disease progression (ie, development of accelerated-phase CML), relapse (ie, loss of complete hematologic or major cytogenetic response), or death. Kaplan-Meier estimates for time for progression-free survival were not performed due the small enrollment population and early termination of the study. What is reported is the number of participants who were alive and progression-free at the time of study termination.|Day 1 to Day 541 (longest progression/survival follow-up)|Enrolled participants|||Participants|||Count of Participants
2608347|NCT02078960|Secondary|Number of Participants Who Had a Molecular Response at Any Time During Treatment|Molecular response was defined by the decrease in the amount of BCR-ABL (an abnormality of chromosome 22) messenger ribonucleic acid (mRNA) measured by reverse transcriptase polymerase chain reaction (RT-PCR) or by the actual percentage of BCR-ABL mRNA transcripts (ratio of BCR-ABL transcript numbers to the number of control gene transcripts).|Day 1 up to Month 15|Enrolled participants|||Participants|||Count of Participants
2608348|NCT02078960|Secondary|Longest Duration of Response At Study Termination|Duration of response was defined for responders as the time interval from the first reported date of a major cytogenetic response (MCyR) or a major hematologic response (MaHR) to the earliest date of objective evidence of disease progression (ie, development of accelerated-phase CML), relapse (ie, loss of complete hematologic or major cytogenetic response), or death. Kaplan-Meier estimates for duration of response were not performed due the small enrollment population and early termination of the study. What is reported is the longest duration of response observed prior to disease progression, death, lost to follow-up or study termination.|Day 1 to Day 541 (longest progression/survival follow-up)|Enrolled participants who had a response|||days|||Number
2610332|NCT02057549|Secondary|Pain Score as Measured by a Visual Analogue Scale (VAS)|The Visual Analogue Scale (VAS) ranges from 0-10, with 0 being the absence of pain and 10 the worst imaginable pain.|1 hour after study medication given||||units on a scale||Standard Deviation|Mean
2608349|NCT02078960|Primary|Number of Participants Who Achieved a Major Response at Any Time During Treatment|"The Independent Data Monitoring Committee assessments are summarized. Major response for participants with chronic phase CML was a major cytogenetic response (MCyR) defined as a complete cytogenetic response with no Ph+ metaphases, or a partial cytogenetic response with up to 35% Ph+ metaphases. Note that a complete hematologic response was not considered a major response.~Major response for participants with accelerated phase CML was a major hematologic response (MaHR) defined as a complete hematologic response or no evidence of leukemia, and/or a major cytogenic response (MCyR)."|Day 1 up to Month 15 (longest treatment duration)|Enrolled participants|||Participants|||Count of Participants
2608350|NCT02078882|Other Pre-specified|Abatacept Levels|Trough serum levels of abatacept|Day 0 and Weeks 4, 12, 24, and 36|||||||
2608351|NCT02078882|Other Pre-specified|Memory T Cell Frequencies|Change in cluster of differentiation 4 (CD4)+ cluster of differentiation 44 (CD44)+ cluster of differentiation 62 ligand (CD62L)- and cluster of differentiation 8+ CD44+ CD62L- frequencies in peripheral blood mononuclear cells from Day 0 to Week 24|Week 24|||||||
2608352|NCT02078882|Other Pre-specified|Immunoglobulin M (IgM) Levels|Change in IgM level from Day 0 to Week 24|Week 24||||mg/dL||Inter-Quartile Range|Median
2608353|NCT02078882|Secondary|Percent Change in Alanine Transferase (ALT)|The percent change in alanine transferase (ALT) from Day 0 to Week 24.|Week 24||||percent change||Inter-Quartile Range|Median
2608354|NCT02078882|Secondary|Percent Change in Alkaline Phosphatase|The percent change in alkaline phosphatase from Day 0 to Week 24.|Week 24||||percent change||95% Confidence Interval|Median
2608355|NCT02078882|Secondary|Primary Billiary Cholangitis Quality of Life|Change in quality of life measured by change in primary biliary cholangitis (PBC)-40 from Day 0 to Week 24. is a patient-derived, disease specific quality of life measure developed and validated for use in PBC with subscores for domains of symptoms, itch, fatigue, cognition, social, and emotional. Subdomains are summed with a total score range of 36 to 200. Higher scores indicate worse quality of life.|Week 24||||units on a scale||Inter-Quartile Range|Median
2608356|NCT02078882|Secondary|Liver Stiffness Measured by Magnetic Resonance Elastography|Change in liver stiffness measured by magnetic resonance elastography from Day 0 to Week 24.|Week 24||||kPa||Inter-Quartile Range|Median
2608357|NCT02078882|Secondary|Absolute Change in Alanine Transferase (ALT)|The absolute change in alanine transferase (ALT) from Day 0 to Week 24.|Week 24||||IU/L||Inter-Quartile Range|Median
2608358|NCT02078882|Secondary|Absolute Change in Alkaline Phosphatase|The absolute change in alkaline phosphatase from Day 0 to Week 24.|Week 24||||IU/L||Inter-Quartile Range|Median
2608359|NCT02078882|Secondary|Drug Safety|Number of participants with any adverse events, clinically significant changes in vital signs, laboratory test abnormalities, and clinical tolerability of the drug.|Weeks 2, 4, 12, 24, and 36||||Participants|||Count of Participants
2608360|NCT02078882|Primary|Biochemical Response|Number of Participants with a decrease of alkaline phosphatase by > 40%of the Day 0 level at 24 weeks of treatment.|Week 24||||Participants|||Count of Participants
2608361|NCT02078817|Secondary|Maximum Decrease in Pulse Oximetry||4 hours||||percent||Standard Deviation|Mean
2608362|NCT02078817|Secondary|Maximum Change in Heart Rate||4 hours||||beats per minute||Standard Deviation|Mean
2608363|NCT02078817|Secondary|Maximum Change in Diastolic Blood Pressure||baseline, 45 minutes post infusion||||mmHg||Standard Deviation|Mean
2608364|NCT02078817|Secondary|Maximum Change in Systolic Blood Pressure|Vital signs were measured every 15 minutes, starting from the beginning of the infusion and ending 2 hours after the infusion ended (2 hours, 40 minutes total). Maximum increase of blood pressure compared to baseline was calculated.|2 hours and 40 minutes||||mmHg||Standard Deviation|Mean
2608365|NCT02078817|Secondary|Change in Clinician Administered Dissociative States Scale (CADSS)|CADSS is a 27-item instrument measuring symptoms of dissociative stress, with 19 items completed by the patient and 8 items completed by the clinician. Items are rated on a scale of 0 (not at all) to 4 (extreme). Total scores are a sum of the 27 item scores and range from 0 to 108, with higher scores indicating greater symptom severity.|baseline, 2 weeks||||score on a scale||Standard Deviation|Mean
2608366|NCT02078817|Secondary|Beck Depression Inventory-II (BDI-II)|BDI-II is a 21-item self-report multiple-choice inventory that assesses the severity of depressive symptoms over the prior week. Items are rated on a 4-point scale ranging from 0 to 3. Total scores are a sum of the 21 item scores ranging from 0 to 63. Higher scores indicate more severe depression symptoms.|2 weeks||||score on a scale||Standard Deviation|Mean
2608367|NCT02078817|Secondary|Montgomery-Åsberg Depression Rating Scale (MADRS)|MADRS is a 10-item clinician-administered inventory measuring depression symptoms. Items are scored on a scare from 0 (none) to 6 (constant). Total scores are a sum of the 10 item scores, ranging from 0 to 60, with higher scores indicating greater symptom severity.|2 weeks||||score on a scale||Standard Deviation|Mean
2608368|NCT02078817|Secondary|Children's Depression Rating Scale-Revised|The CDRS-R measure is given in interview form to child and parent separately. A consensus is then created with best-estimate for 17 items (each with a range of 1-5 or 1-7) using both sources of information. The total score is the sum of 17 item scores, ranging from 17-113 with higher scores indicating greater depression symptoms.|2 weeks||||score on a scale||Standard Deviation|Mean
2608369|NCT02078817|Primary|Number of Responders Measured by Clinical Global Impression (CGI)|Responders will be defined as those with CGI ratings (given by the study clinician) of 1 or 2 (much or very much improved). Patients that are given a scores of 3-7 (minimally improved to very much worse) will be considered non-responders.|2 weeks||||Participants|||Count of Participants
2608370|NCT02078752|Secondary|Overall Survival (OS)-Stratifying for EFNA4 Expression (Part 2)||Baseline up to 24 months|OS was not estimable since there were fewer number of participants with event.||||||
2608371|NCT02078752|Secondary|Progression Free Survival|The progression free survival (PFS) was defined as the time from Cycle 1 Day 1 to first documentation of disease progression or to death due to any cause, whichever occurred first. PFS was characterized by the estimate median time to event which was derived using Kaplan-Meier method.|Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months|The analysis set included the number of participants with event.|||month||95% Confidence Interval|Median
2608372|NCT02078752|Secondary|Percentage of Participants With Clinical Benefit Response|Clinical Benefit Response (CBR) was defined as a CR, PR or stable disease (SD) ≥6 cycles. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as the reference of baseline sum diameters. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (progressive disease: >=20% increase in the sum of diameters of target lesions and an absolute increase of >=5mm or appearance of >=1 new lesion), taking as reference the smallest sum diameters while on study.|Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months|The analysis set included the number of participants with measurable disease at baseline.|||Percentage of participants||95% Confidence Interval|Number
2608373|NCT02078752|Secondary|Percentage of Participants With Objective Response (Part 1)|Objective response rate (ORR) refers to percentage of participants who achieved complete response (CR) or partial response (PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.|Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months|The analysis set included treated participants with measurable disease at baseline.|||Percentage of participants||95% Confidence Interval|Number
2608374|NCT02078752|Secondary|Number of Participants With Treatment-Emergent and Treatment-Boosted Anti PF-06647263 Antibody|Treatment-Emergent=Baseline negative with at least one positive ADA sample post-treatment. Treatment-Boosted=Baseline positive but endpoint titer (log10-scale titer) increases by at least 0.5 (representing 3-fold titer increase). In time frame, C=cycle, D=day.|QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.|"Number of Participants Analyzed represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. Number Analyzed represents the number of participants tested for that parameter."|||Participants|||Count of Participants
2608375|NCT02078752|Secondary|Number of Participants With Positive Neutralizing Anti PF-06647263 Antibody|Positive was defined as: neutralizing antibody titer >=1.30. In time frame, C=cycle, D=day.|QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.|The analysis set included all participants who were treated and tested for that parameter.|||Participants|||Count of Participants
2608376|NCT02078752|Secondary|Number of Participants With Positive Antibodies for PF-06647263, Total Antibody (PF-06523432), and Unconjugated Payload (CL-184538)|Positive was defined as: anti-drug antibody (ADA) titer >=1.88. In time frame, C=cycle, D=day.|QW: C1:D1&D15; every other cycle: D1; end of treatment. Q3W:C1: D1&D15; Cycles 2 through 4: D1; every other cycle: D1; end of treatment.|"Number of Participants Analyzed represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. Number Analyzed represents the number of participants tested for that parameter."|||Participants|||Count of Participants
2608377|NCT02078752|Secondary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)|Following parameters were analyzed for laboratory examination: hematology, blood chemistry, coagulation panel, urinalysis and pregnancy test.|Baseline up to 7 days post end of treatment (Approximately 13 months)|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.|||Participants|||Count of Participants
2608378|NCT02078752|Secondary|Cmax of Unconjugated Payload CL-184538|Cmax was determined directly from data. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538).|Every Cycle: Days 1, 8, 15. up to end of treatment (Approximately 13 months)|The analysis set was defined as enrolled patients who were analyzed for pharmacokinetics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2608379|NCT02078752|Secondary|t1/2 of Total Antibody|T1/2 was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. The t1/2 analysis only applied to Q3W group. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.|Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.|"Number of Participants Analyzed represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. Number Analyzed represents the number of participants contributing to the PK parameter summary statistics at that time point."|||day||Standard Deviation|Mean
2608380|NCT02078752|Secondary|Vss of Total Antibody|Vss was determined by CL × MRT (mean residence time). MRT=[AUMCtau +tau(AUCinf-AUCtau)]/AUCtau. AUMCtau was the area under the first moment curve derived using the linear/log trapezoidal method. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.|QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.|"Number of Participants Analyzed represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. Number Analyzed represents the number of participants contributing to the PK parameter summary statistics at that time point."|||L||Geometric Coefficient of Variation|Geometric Mean
2608381|NCT02078752|Secondary|CL of Total Antibody|For single dose, CL was determined by Dose/AUCinf while for multiple dose, CL was determined by Dose/AUCtau. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.|QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.|"Number of Participants Analyzed represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. Number Analyzed represents the number of participants contributing to the PK parameter summary statistics at that time point."|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2608382|NCT02078752|Secondary|Tmax of Total Antibody|Tmax was determined directly from data as time of first occurrence. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.|QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.|"Number of Participants Analyzed represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. Number Analyzed represents the number of participants contributing to the PK parameter summary statistics at that time point."|||hr||Full Range|Median
2608383|NCT02078752|Secondary|Cmax of Total Antibody|Cmax was determined directly from data. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.|QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.|"Number of Participants Analyzed represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. Number Analyzed represents the number of participants contributing to the PK parameter summary statistics at that time point."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2608384|NCT02078752|Secondary|AUCtau of Total Antibody|Tau is dosing interval, where tau=168 hours for the QW dosing and 504-hour for the Q3W dosing. AUC tau was determined by linear/log trapezoidal method. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538). In time frame, C=cycle, D=day.|QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.|"Number of Participants Analyzed represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. Number Analyzed represents the number of participants contributing to the PK parameter summary statistics at that time point."|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2608385|NCT02078752|Secondary|AUC504 of Total Antibody|AUC504 was determined by linear/log trapezoidal method. AUC504 analysis only applied to QW groups. PF-06647263 is an antibody-drug conjugate (ADC) which comprises total antibody (PF-06523432) and unconjugated payload ( CL-184538).|Cycle 1 Day 1: predose, 1, 4, 24, 72 hrs postdose, Cycle 1 Days 8 and 15: predose, 1 and 72 hrs postdose, up to Cycle 2 Day 1 predose (504 hr).|The analysis population was defined as all enrolled patients treated who had sufficient information to estimate AUC504.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2608386|NCT02078752|Secondary|Terminal Serum Half-life (t1/2) of PF-06647263|T1/2 was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. The t1/2 analysis only applied to Q3W group. In time frame, C=cycle, D=day.|Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.|"Number of Participants Analyzed represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. Number Analyzed represents the number of participants contributing to the PK parameter summary statistics at that time point."|||day||Standard Deviation|Mean
2608387|NCT02078752|Secondary|Volume of Distribution at Steady State (Vss) of PF-06647263|Vss was determined by CL × MRT (mean residence time). MRT=[AUMCtau +tau(AUCinf-AUCtau)]/AUCtau. AUMCtau was the area under the first moment curve derived using the linear/log trapezoidal method. In time frame, C=cycle, D=day.|QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.|"Number of Participants Analyzed represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. Number Analyzed represents the number of participants contributing to the PK parameter summary statistics at that time point."|||L||Geometric Coefficient of Variation|Geometric Mean
2608388|NCT02078752|Secondary|Clearance (CL) of PF-06647263|For single dose, CL was determined by Dose/AUCinf while for multiple dose, CL was determined by Dose/AUCtau. AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time. In time frame, C=cycle, D=day.|QW: C1D15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.|"Number of Participants Analyzed represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. Number Analyzed represents the number of participants contributing to the PK parameter summary statistics at that time point."|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2608389|NCT02078752|Secondary|Time for Cmax (Tmax) of PF-06647963|Tmax was determined directly from data as time of first occurrence. In time frame, C=cycle, D=day.|QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.|"Number of Participants Analyzed represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. Number Analyzed represents the number of participants contributing to the PK parameter summary statistics at that time point."|||hr||Full Range|Median
2608390|NCT02078752|Secondary|Maximum Observed Serum Concentration (Cmax) of PF-06647263|Maximum observed serum concentration Cmax was determined directly from data. In time frame, C=cycle, D=day.|QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.|"Number of Participants Analyzed represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. Number Analyzed represents the number of participants contributing to the PK parameter summary statistics at that time point."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2608415|NCT02078713|Secondary|Shared Decision Making - Who Made the Decision?|Patient response to 5-point scale of who made decision on contraceptive method. The original 5 points were the provider by themselves, more provider, both equally, more patient, or provider by themselves. In analysis, these options were collapsed to three points: more provider, both equally, or more patient.|Baseline (post-visit)|Observed in patients only|||Participants|||Count of Participants
2608391|NCT02078752|Secondary|Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-06647263|Tau is dosing interval, where tau=168 hours for the QW dosing and 504-hour for the Q3W dosing. AUC tau was determined by linear/log trapezoidal method. In time frame, C=cycle, D=day.|QW: C1D1: predose, 1,4,24,72 hrs postdose, C1D8 & 15: predose, 1 & 72 hrs postdose, up to C2D1 predose. Q3W: C1D1: predose,1,4 and 24 hrs postdose, C1D4,8,15 up to C2D1 predose; C4D1: pre-dose,1,4 and 24 hrs postdose, C4D4,8,15 up to C5D1 predose.|"Number of Participants Analyzed represents the number of participants who were enrolled and received at least 1 dose of PF-06647263. Number Analyzed represents the number of participants contributing to the PK parameter summary statistics at that time point."|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2608392|NCT02078752|Secondary|Area Under the Serum Concentration-time Profile From Time 0 to the 504-hour Time Point (AUC504) of PF-06647263|AUC504 was determined by linear/log trapezoidal method. AUC504 analysis only applied to QW groups.|Cycle 1 Day 1: predose, 1, 4, 24, 72 hrs postdose, Cycle 1 Days 8 and 15: predose, 1 and 72 hrs postdose, up to Cycle 2 Day 1 predose (504 hr).|The analysis population was defined as all enrolled patients treated who had sufficient information to estimate AUC504.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2608393|NCT02078752|Secondary|Number of Participants With Vital Signs Abnormalities|Following parameters were analyzed for examination of vital signs: sitting systolic and diastolic blood pressure (SBP & DBP), and sitting pulse rate. The abnormal criteria were: (1) minimum SBP <90mmHg; (2) SBP change from baseline, maximum decrease >=30mmHg or maximum increase >=30mmHg; (3) minimum DBP <50mmHg; (4) DBP change from baseline, maximum decrease >=20mmHg or maximum increase >=20mmHg; (5) minimum supine pulse rate <40 BPM or maximum supine pulse rate >120 BPM.|Baseline, Days 1, 8, 15 of each cycle, and post treatment period. (Approximately 13 months)|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.|||Participants|||Count of Participants
2608394|NCT02078752|Secondary|Number of Participants With Treatment-Emergent SAEs (Treatment-related, All Cycles)|A SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.|Baseline up to 28 days after the last treatment administration (Approximately 13 months)|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.|||Participants|||Number
2608395|NCT02078752|Secondary|Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) (All Causality, All Cycles)|A SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.|Baseline up to 28 days after the last treatment administration (Approximately 13 months)|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.|||Participants|||Number
2608396|NCT02078752|Secondary|Number of Participants With Treatment-Emergent AEs (Treatment-related, All Cycles)|An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.|Baseline up to 28 days after the last treatment administration (Approximately 13 months)|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.|||Participants|||Number
2608397|NCT02078752|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) (All Causality, All Cycles)|An AE was any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent.|Baseline up to 28 days after the last treatment administration (Approximately 13 months)|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06647263.|||Participants|||Count of Participants
2608398|NCT02078752|Primary|Percentage of Participants With Objective Response (Part 2)|Objective response rate (ORR) refers to percentage of participants who achieved complete response (CR) or partial response (PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: >= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.|Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months|The analysis set included all treated participants in Part 2 with measurable disease at baseline.|||Percentage of Participants||95% Confidence Interval|Number
2608399|NCT02078752|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) (Part 1)|DLTs were defined as any of the following adverse events (AEs) which were not considered related to disease progression occurring in the first cycle of treatment:(1)Hematologic: grade 4 neutropenia lasting >7 days; febrile neutropenia (defined as neutropenia >=Grade 3 and a single body temperature >38.3°C or a sustained temperature of >=38°C for more than 1 hour); grade >=3 neutropenia with infection; any grade thrombocytopenia associated with clinically significant or life threatening bleeding; grade 4 thrombocytopenia >=72 hours or platelets <=10,000/mm^3 regardless of duration. (2)Non- hematologic: bilirubin increase >=2 × upper limit of normal (ULN) and not related to disease progression or other known cause; all other Grade >=3 toxicities, except those that had not been maximally treated (eg, nausea, vomiting, diarrhea); delay by more than 2 weeks in receiving the next scheduled cycle due to persisting toxicities not attributable to disease progression.|Baseline up to Cycle 2 Day 1 (22 days)|The analysis set included all enrolled participants who received at least 1 dose of PF-06647263.|||Participants|||Count of Participants
2608400|NCT02078713|Other Pre-specified|Unplanned Pregnancy|Incidence of unplanned pregnancy among study participants, as determined by responses of patients who experienced a pregnancy to the 6-item London Measure of Unplanned Pregnancy. The London Measure includes items on attitude towards an experienced pregnancy and behaviors before pregnancy to determine the intendedness of pregnancy. The score range of the London Measure is 0-12, with a score of <10 indicating unplanned pregnancy and a score of 10 or higher indicating planned pregnancy. We report the percentage of patients who report a pregnancy and report a score of <10 on the London Measure.|4 months and 7 months from enrollment|Observed in patients only|||Participants|||Count of Participants
2608401|NCT02078713|Other Pre-specified|Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up|Patient report of whether or not patient is using a highly or moderately effective contraceptive method at 4 and 7 month follow-up survey. As defined by the Centers for Disease Control, moderately effective methods include injectables, pills, patch, vaginal ring, and diaphragm; typical failure rates range from 6-12%. Highly effective methods include implants, IUDs, and male and female sterilization; failure rates are less than 1%.|4 and 7 months post-enrollment||||Participants|||Count of Participants
2608402|NCT02078713|Other Pre-specified|Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up.|Whether patient is using a highly effective contraceptive method at 4 and 7 month follow-up survey. Highly effective methods include implant, IUDs, and male and female sterilization.|4 and 7 months post-enrollment|Observed in patients only|||Participants|||Count of Participants
2608403|NCT02078713|Other Pre-specified|Choice of a Highly Effective Method of Contraception at Baseline|Patient report of whether or not patient chose highly effective method at baseline. Highly effective methods include implants, IUDs, and male and female sterilization.|Baseline (post-visit survey)|Observed in patients only|||Participants|||Count of Participants
2608404|NCT02078713|Secondary|Maslach Burnout Inventory|Provider participants were asked to respond to the Maslach Burnout Inventory on workplace burnout among human services workers. The scale includes 22 items with response options on a Likert scale of 0-6. Individual scores were calculated at both baseline and follow-up for three subscales: emotional exhaustion (Range: 0-54, with higher score representing higher emotional exhaustion), depersonalization (Range: 0-30, with a higher score representing higher depersonalization), and personal accomplishment (Range: 0-48, with a higher score representing more personal accomplishment in the workplace).|Change between baseline and end of study (up to 24 months post-enrollment). In multivariate analysis, follow-up score analyzed controlling for site and score at baseline (Analyses 1-3).|Observed in providers only|||Units on a scale||Standard Deviation|Mean
2608405|NCT02078713|Secondary|Time Spent With Contraceptive Counseling Provider|Total amount of time spent with the provider that is providing contraceptive counseling.|Baseline visit|Observed in patients|||minutes||Standard Deviation|Mean
2608406|NCT02078713|Secondary|Total Clinic Visit Time|Total amount of time a patient spends in a clinic for a family planning visit, from check-in to check-out.|Baseline visit|Observed in patients only|||minutes||Standard Deviation|Mean
2608407|NCT02078713|Secondary|"Patient Rating of Visit as Much Better Than Previous Family Planning Visit"|Patient report on 5-point Likert scale question asking patient to compare this visit to last family planning visit (1=Today was much worse; 5=today was much better). Analyzed dichotomously as top score of 5 versus <5.|Baseline (post-visit survey)|Observed in patients only. Only calculated among those participants who reported ever having had a family planning visit. All others missing.|||Participants|||Count of Participants
2608408|NCT02078713|Secondary|Newly Heard About Methods During Visit|Percentage of patients who reported having heard about a method in the post-survey, but not the pre-survey.|Baseline (pre- and post-survey)|Only calculated for those patients who reported not having heard of method in pre-survey, and then completed post-survey. All other patients missing for this item and excluded from analysis.|||Participants|||Count of Participants
2608409|NCT02078713|Secondary|Patient Attitude Towards Use of Contraceptive Options|"Patient ratings of contraceptive methods on the 11-point Global Contraceptive Attitude scale, developed by the PI. To assess overall (or global) attitude towards use of various methods, patients are asked to respond the following with regard to each method listed in the data table: Overall, how would you rate each of the following as a birth control method for yourself, (even if you've never used it)? Response options range from 0 (Terrible method) to 10 (Great method). A higher score on an individual item indicates a more positive attitude towards a method. Analyzed as discrete items with responses of 0 to 10; item scores not combined into an overall scale score."|Baseline (post-visit survey)|Observed in patients only.|||Units on a scale||Standard Error|Mean
2608410|NCT02078713|Secondary|Patient Current Contraceptive Method Satisfaction|"5-point Likert scale question regarding patient satisfaction with the contraceptive method they are currently using. The item is a statement of method satisfaction, and response options range from 1 (Completely disagree) to 5 (Completely agree). A higher score indicates higher satisfaction. Analyzed dichotomously as top score of 5 versus <5."|7 months follow-up|Observed in patients only|||Participants|||Count of Participants
2608411|NCT02078713|Secondary|Patient Chosen Contraceptive Method Satisfaction|"5-point Likert scale item regarding patient satisfaction with contraceptive method chosen at baseline visit. The item is a statement of method satisfaction, and response options range from 1 (Completely disagree) to 5 (Completely agree). A higher score indicates higher satisfaction. Analyzed dichotomously as top score (5) versus all lower scores."|Reported and analyzed at baseline (post-visit), 4 months and 7 months follow-up||||Participants|||Count of Participants
2608412|NCT02078713|Secondary|Patient Knowledge of Contraceptive Options and Features|Patient responses to items derived from National Survey of Reproductive Contraceptive Knowledge and previous studies of contraceptive knowledge and attitudes. All items analyzed as correct vs. incorrect.|Baseline (post-visit)|Observed in patients only|||Participants|||Count of Participants
2608413|NCT02078713|Secondary|Patient Decisional Conflict in Contraceptive Choice|"Patient Decisional Conflict was measured using the Decisional Conflict Scale (DCS), a validated measure to assess patients' decisional conflict in medical decision making. The DCS includes 16 items about experience of conflict, with 5-point Likert response options ranging from 0 (Strongly disagree) to 4 (Strongly agree). Higher scores indicate less conflict. Top score on DCS (Range: 0-100, analyzed dichotomously as 100 versus <100). Top scores on subscales also analyzed (Informed decision, Uncertainty, Effective decision, Values clarity, Support, all ranging 0-100 and analyzed dichotomously as 100 versus <100)."|Baseline (post-visit)|Observed in patients only|||Participants|||Count of Participants
2608418|NCT02078713|Secondary|Shared Decision Making - Feelings About Provider Involvement|Patient report on 3-point scale of their feelings about provider involvement in contraceptive decision-making: I wish provider had been less involved, provider was involved the right amount, I wiss provider had been more involved.|Baseline (post-visit) and up to 24 months|Observed in patients only|||Participants|||Count of Participants
2608419|NCT02078713|Secondary|Overall Satisfaction With Visit|Patient report on 5-point Likert scale of satisfaction with baseline visit (1=completely unsatisfied, 5=completely satisfied). Analyzed dichotomously as top score of 5 versus <5.|Baseline (post-visit survey)|Observed in patients only|||Participants|||Count of Participants
2608420|NCT02078713|Secondary|Patient Satisfaction With Information Received About Side Effects During Counseling|Patient response to a 5-point Likert scale item about satisfaction with information that their provider gave them about side effects of their chosen methods during their baseline visit (1=completely unsatisfied, 5=completely satisfied). Analyzed dichotomously as top score of 5 versus <5.|Baseline (post-visit survey)|Observed in patients only|||Participants|||Count of Participants
2608421|NCT02078713|Secondary|Patient Contraceptive Counseling Satisfaction|"Patient-reported score on an 11-item factor analysis-validated measure created by the PI to assess patients' satisfaction with the contraceptive counseling experience. The measure consists of 5-point Likert scale items on which patients evaluate provider performance, with item response options ranging from 1 (Poor) to 5 (Excellent). The score range for the total measure is11-55, with 11 as the worst possible score and 55 as the best possible score for provider performance. Analyzed dichotomously, top score (55) versus all lower scores."|Baseline, post-visit survey|Observed in patients only|||Participants|||Count of Participants
2608422|NCT02078713|Primary|Contraceptive Continuation|Whether or not a participant is still using the contraceptive method she selected at baseline.|4 and 7 months post-enrollment|Analysis was modified intention to treat. In accordance with the statistical analysis plan, patients were excluded from analysis if they were pregnant at baseline (n=8) or enrolled in the study twice (n=1, in which case information from their second enrollment was excluded). Outcome observed in patients only.|||Participants|||Count of Participants
2608423|NCT02078557|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or disease temporally associated with the use of the study drug or a study procedure, whether or not considered related to the study drug or study procedure. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse event.|Up to 28 days|All participants who received at least one dose of the investigational drug|||Participants|||Count of Participants
2608424|NCT02078557|Primary|Number of Participants Who Experienced an Adverse Event|An adverse event was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or disease temporally associated with the use of the study drug or a study procedure, whether or not considered related to the study drug or study procedure. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse event.|Up to 42 days|All participants who received at least one dose of the investigational drug|||Participants|||Count of Participants
2608425|NCT02078557|Primary|Percentage Change From Baseline in Pulmonary Vascular Resistance (PVR)|Pulmonary vascular resistance (PVR) is the general pressure which the right ventricle must counteract to pump blood through the lungs. PVR was measured by right heart catheterization performed prior to dosing at baseline (Day 1) and 4 hours postdose on Day 28. Percentage change in PVR from baseline at Day 28 was calculated as [(Baseline-Day 28)/Baseline]. Standard deviation is reported as a percentage.|Baseline and Day 28|The population for the efficacy analysis consisted of all participants who completed the 28 days of study.|||Percentage change||Standard Deviation|Mean
2608426|NCT02078492|Secondary|Adverse Effect of Headache|The number of study patients who reported headache after administration of medication|120 minutes||||Participants|||Count of Participants
2608427|NCT02078492|Secondary|Adverse Effect of Nausea|The number of study patients who reported nausea after administration of medication|120 minutes||||Participants|||Count of Participants
2608428|NCT02078492|Secondary|Adverse Effect of Dizziness|the number of study patients who reported having dizziness after administration of medication.|120 minutes||||Participants|||Count of Participants
2608429|NCT02078492|Primary|Pain Score at 30 Minutes|Pain score of each group at 30 minutes. The Numeric Rating Pain (NRS) scale was used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). A score of 5 is moderate pain. The higher the pain score the higher the pain severity.|30 minutes||||pain score||Standard Deviation|Mean
2608430|NCT02078219|Secondary|Absolute Change of Serum Uric Acid Levels From Baseline Levels|To compare the absolute change of serum uric acid levels from baseline levels|Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24|Efficacy analysis set|||mg/dL||Standard Deviation|Mean
2608431|NCT02078219|Secondary|Percent Change in sUA|To compare percent change in sUA at each study visit.|Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24|Efficacy analysis set|||% Change||Standard Deviation|Mean
2608432|NCT02078219|Secondary|Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL|To compare the percentage of subjects whose serum uric acid levels are ≤ 6.0 mg/dL between RDEA3170 treatment groups and the placebo treatment group at each study visit|Weeks 1,2,4,6,8,10,12,16,18,20,24|Efficacy analysis set|||% subjects|||Number
2608433|NCT02078219|Primary|Percent Changes of Serum Uric Acid Levels From Baseline Levels|The primary objective of the study is to compare percent changes of serum uric acid levels from baseline levels after 16 weeks of dosing between RDEA3170 treatment groups and the placebo treatment group.|Baseline and Week 16|Efficacy analysis set|||Percent change||Standard Deviation|Mean
2608434|NCT02078193|Other Pre-specified|Number of Participants With Chronic Kidney Rejection|Incidence of chronic kidney rejection|One year||||participants|||Number
2608435|NCT02078193|Secondary|Safety|Incidence of infections|one year|Number of participants with infections|||Participant|||Number
2608436|NCT02078193|Primary|Change of Donor Specific Antibodies (DSA)|DSA levels will be measured using microbeads coated with Class I or Class II human leukocyte antigens (HLA) and read using a Luminex flow cytometer. Participants will be converted from their current Mycophenolate Mofetil (MMF) to once a month infusions of Belatacept.|one year||||percent change in DSAs||Standard Deviation|Mean
2608437|NCT02078180|Secondary|Comparision of the Buproprion Maximum Concentration (Cmax) by Type of Formulation and Dosage|Each formulation of buproprion has a different rate of release. Some release the drug immediately while others release the drug slowly. We will compare the exposure of buproprion by formulation and dose by looking at the maximum concentration. The maximum concentration depends on the rate of drug release and so looking at this value can help us compare differences between formulation.|4 days||||nanogram/milliliter||Standard Error|Mean
2608438|NCT02078180|Primary|Comparision of the Buproprion Area Under the Concentration Time Curve (AUC) From Time 0 to 96 Hours by Type of Formulation and Dosage|Each formulation of buproprion has a different rate of release. Some release the drug immediately while others release the drug slowly. We will compare the exposure of buproprion by formulation and dose by looking at the area under the concentration time curve. The area under the concentration time curve is a mathematical way of looking at drug exposure in the body. The reported values are AUC (0-96 hours).|4 days||||h*nanogram/milliliter||Standard Deviation|Mean
2608439|NCT02077374|Secondary|Levels of flCK18/M65|Difference in the change in full-length cytokeratin 18 (flCK18/M65) in units per liter (U/L) from Baseline to Day 28/ET between IDN-6556 and placebo|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.|||U/L||Full Range|Median
2608440|NCT02077374|Secondary|Levels of Caspase 3/7 RLU|Difference in the change of caspase 3/7 (Relative Light Units) from baseline to Day 28/ET between IDN-6556 and Placebo|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.|||RLU||Full Range|Median
2608441|NCT02077374|Secondary|Levels of cCK18/M30|Difference in the change in Caspase-cleaved cytokeratin serum levels (cCK18/M30) in units per liter (U/L) from baseline to Day 28/ET between IDN-6556 and placebo|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.|||U/L||Full Range|Median
2608442|NCT02077374|Secondary|Change in Aspartate Aminotransferase (AST)|Difference in the change in aspartate aminotransferase (AST) from Baseline to Day 28/ET in units per liter (U/L) between IDN-6556 and placebo.|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.|||U/L||Full Range|Median
2608443|NCT02077374|Primary|Relative Percent Change in Alanine Aminotransferase (ALT)|Back transformation from log-transformed analysis results to original scale in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo|Baseline to Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.|||Relative percent change||Standard Deviation|Mean
2608444|NCT02077374|Primary|Change in Alanine Aminotransferase (ALT)|Mean change in alanine aminotransferase (ALT) from Baseline to Day 28/ET between IDN-6556 vs Placebo|Day 28/ET|The full analysis set (FAS) included all subjects who were randomized and received at least one dose of study drug. For the FAS, subjects were assigned to the treatment group based on the randomization schedule, regardless of the treatment they actually received. All efficacy analyses were conducted on the FAS.|||U/L||Standard Deviation|Mean
2608445|NCT02077140|Other Pre-specified|Subject's Satisfaction With Study Treatment (Exploratory Analysis)|Subject's satisfaction with study treatment as measured by a 5-point categorical scale where 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent|up to 72hrs|The efficacy analyses of Cohort 1 to 4 were considered for exploratory analyses.|||Participants|||Count of Participants
2608446|NCT02077140|Other Pre-specified|Time to First Use of Opioid Analgesia (Exploratory Analysis)||up to 96hrs|The efficacy analyses of Cohort 1 to 4 were considered for exploratory analyses.|||hours||95% Confidence Interval|Median
2608447|NCT02077140|Other Pre-specified|Total Use of Opioid Analgesia (Exploratory Analysis).||over 0 to 24hrs, 0 to 48hrs, 0 to 72hrs, and 0 to 96hrs|The efficacy analyses of Cohort 1 to 4 were considered for exploratory analyses.|||morphine mg equivalent||Standard Deviation|Mean
2608448|NCT02077140|Other Pre-specified|Summed Pain Intensity Scores (Exploratory Analysis)|The theoretical range for SPI-24, SPI-48, SPI-72, and SPI-96 is 0 to 230, 0-470, 0-710, and 0-960, respectively, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). Summed pain intensity is calculated as area under the curve, using the trapezoidal rule to bridge adjacent time points. Specifically, NRS scores for two adjacent time points are averaged and then multiplied by the time span between points (in hours).|over 1 to 24hr, 1 to 48 hrs, 1 to 72hrs, and 1 to 96hrs|The efficacy analyses of Cohort 1 to 4 were considered for exploratory analyses.|||units on a scale||Standard Deviation|Mean
2608449|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Terminal Phase Rate Constant (λz)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.|||/hr||Standard Deviation|Mean
2608450|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Terminal Plasma Half-life (t½)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.|||hrs||Standard Deviation|Mean
2610610|NCT02054156|Secondary|Time to Pseudomonas Aeruginosa (Pa) Recurrence|Time to Pseudomonas aeruginosa (Pa) recurrence after the first quarter of treatment|Over the 18-month study period||||years||95% Confidence Interval|Median
2608451|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Lag Time Before First Measurable Drug Concentration (Tlag)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.|||hrs||Full Range|Median
2608452|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Time to Maximum Plasma Concentration Observed (Tmax)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.|||hrs||Full Range|Median
2608453|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Maximum Observed Plasma Concentration (Cmax)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.|||pg/mL||Standard Deviation|Mean
2608454|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-∞)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.|||h*pg/mL||Standard Deviation|Mean
2608455|NCT02077140|Other Pre-specified|Pharmacokinetic (PK) Parameters of MDT-10013: Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-t)|Blood samples were taken for pharmacokinetic parameters of MDT-10013 determinations before surgery on Day 0; at 1, 2, 4, 6, 8, 12, 24, 48, 72, and 96 hours after Time 0 (96-hour sample for Cohort 4 only); and on Days 7 to 10 after Time 0. Time 0 was defined as the time the capsule was closed. Actual sampling times after T0 (to 1/1000th of an hour) were used to calculate PK parameters.|up to 10 days|PK analysis population consisted of all subjects who had PK samples analyzed.|||h*pg/mL||Standard Deviation|Mean
2608456|NCT02077140|Secondary|Subject's Satisfaction With Study Treatment|Subject's satisfaction with study treatment as measured by a 5-point categorical scale where 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent|up to 72hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.|||Participants|||Count of Participants
2608457|NCT02077140|Secondary|Time to First Use of Opioid Analgesia||up to 96hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.|||hours||95% Confidence Interval|Median
2608458|NCT02077140|Secondary|Total Use of Opioid Analgesia Over 0 to 24hrs, 0 to 48hrs, 0 to 72hrs, and 0 to 96hrs.|Total use of opioid analgesia over 0 to 24hrs, 0 to 48hrs, 0 to 72hrs, and 0 to 96hrs. The analgesia administered was converted to a morphine equivalent by using a standard conversion table.|over 0 to 24hrs, 0 to 48hrs, 0 to 72hrs, and 0 to 96hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.|||morphine mg equivalent||Standard Deviation|Mean
2608459|NCT02077140|Secondary|Summed Pain Intensity Scores Over 1- 24hrs (SPI-24), 1- 72hrs (SPI-72) and 1- 96hrs (SPI-96)|The theoretical range for SPI-24, SPI-72, and SPI-96 is 0 to 230, 0-710, and 0-960, respectively, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). Summed pain intensity is calculated as area under the curve, using the trapezoidal rule to bridge adjacent time points. Specifically, NRS scores for two adjacent time points are averaged and then multiplied by the time span between points (in hours).|over 1 to 24hrs, 1 to 72hrs, and 1 to 96hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.|||units on a scale||Standard Deviation|Mean
2608460|NCT02077140|Primary|Summed Pain Intensity Over 1- 48hrs (SPI-48)--Sensitivity Analysis Using Windowed Worst Observation Carried Forward (WOCF)|Similar to SPI-48, the theoretical range for this WOCF adjustment for rescue medication is 0-470, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). The calculation is identical in terms of area-under the curve using the trapezoidal rule. However, the NRS score at the final assessment prior to each instance of rescue medication is carried forward through for a window based on the approximate half-life of the drug, replacing the raw NRS scores post-rescue for each patient until the end of the pharmacological activity window, at which point calculations revert to raw NRS as applicable. Note that WOCF SPI-48 may include multiple adjustment windows for each patient, depending on the number or rescue events and the active life of the medication selected.|over 1 to 48hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.|||units on a scale||Standard Deviation|Mean
2608461|NCT02077140|Primary|Integrated Summed Pain Intensity Over 1- 48hrs (SPI-48) and Total Opioid Intake in First 48hrs --Sensitivity Analysis Using Silverman Method|This sensitivity analysis is an integrated assessment of summed pain intensity over 1 to 48hrs (SPI-48) and total opioid intake (ME0-48) in first 48hrs. Briefly, subjects were ranked according to SPI-48 regardless of the treatment received (including Standard of Care, SOC). The mean of all the ranks for this variable was calculated. Then, the percent difference for each individual rank from the pooled mean rank was computed. This process was repeated for total opioid intake in the first 48hrs (ME0-48). The integrated endpoint for each subject was the sum of the rank order percent differences for SPI-48 and ME0-48. The theoretical minimum and maximum on the integrated endpoint are -197% and +197% in this study. Lower scores are better, indicative of less pain and/or less opioid intake.|over 1 to 48hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.|||percent difference||Standard Deviation|Mean
2608462|NCT02077140|Primary|Summed Pain Intensity Over 1- 48hrs (SPI-48)--Sensitivity Analysis Using Last Observation Carried Forward (LOCF)|Similar to SPI-48, the theoretical range for this LOCF adjustment for rescue medication is 0-470, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). The calculation is identical to SPI-48 in terms of area-under the curve using the trapezoidal rule. However, the NRS score at the final assessment prior to rescue is carried forward through 48 hours, replacing the raw NRS scores post-rescue for each patient as applicable.|over 1 to 48hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.|||units on a scale||Standard Deviation|Mean
2608463|NCT02077140|Primary|Summed Pain Intensity Over 1- 48hrs (SPI-48) From Cohort 1 to 3|Summed pain intensity is a time-weighted average pain score in numeric rating scale (NRS) over 1 to 48hrs (SPI-48). Summed pain intensity is calculated as area under the curve, using the trapezoidal rule to bridge adjacent time points. Specifically, NRS scores for two adjacent time points are averaged and then multiplied by the time span between points (in hours). The theoretical range for SPI-48 is 0 to 470, with lower scores indicative of less pain over this time period (i.e., lower scores are consistent with better analgesia). Time 0 was defined as the time the capsule was closed.|over 1 to 48hrs|The primary efficacy analysis was based on the Full Analysis dataset of Cohort 1 to 3. Full Analysis dataset included Safety population (i.e., all subjects who received at least 1 MDT-10013 strip or completed surgery in a standard-of-care group based on the actual treatment a subject received) having at least 1 postoperative pain assessment.|||units on a scale||Standard Deviation|Mean
2608464|NCT02076919|Secondary|Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2|Mean arterial blood pressure (average pressure in the arteries during one cardiac cycle) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 2.|||mmHg||Standard Error|Least Squares Mean
2608465|NCT02076919|Secondary|Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2|Systolic blood pressure (pressure when the heart is contracting) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 2.|||mmHg||Standard Error|Least Squares Mean
2608466|NCT02076919|Secondary|Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2|Diastolic blood pressure (pressure in the arteries when the heart rests between beats) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 2.|||mmHg||Standard Error|Least Squares Mean
2608467|NCT02076919|Secondary|Change From Baseline in Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 1|Mean arterial blood pressure (average pressure in the arteries during one cardiac cycle) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 1.|||mmHg||Standard Error|Least Squares Mean
2608468|NCT02076919|Secondary|Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 1|Systolic blood pressure (pressure when the heart is contracting) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 1.|||mmHg||Standard Error|Least Squares Mean
2608469|NCT02076919|Primary|Number of Subjects Experiencing a Non-serious Adverse Event, Part 2|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.|From time of consent until 30 days after stopping the trial/study drug|This analysis population includes all enrolled subjects in Part 2.|||participants|||Number
2608481|NCT02076425|Other Pre-specified|Children's Global Assessment Scale (CGAS) Score|The Children's Global Assessment Scale (CGAS) is a standardized instrument that measures children's global level of impairment completed by the clinician-rater. The possible range of values is 0-100, with 0 indicating the most severe global impairment.|completion of therapy (average of 20 weeks)||||units on a scale (0-100)||Standard Deviation|Mean
2608470|NCT02076919|Primary|Number of Subjects Experiencing a Non-serious Adverse Event, Part I|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.|From time of consent until 30 days after stopping the trial/study drug|This analysis population includes all enrolled subjects in Part 1.|||participants|||Number
2608471|NCT02076919|Secondary|Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 1|Diastolic blood pressure (pressure in the arteries when the heart rests between beats) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.|Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose|This analysis population includes all enrolled subjects in Part 1.|||mmHg||Standard Error|Least Squares Mean
2608472|NCT02076919|Secondary|The Terminal Elimination Half-life [Time] (T1/2), Part 2|Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.|Up to Day 15|This analysis population includes all enrolled subjects in Part 2.|||hour||Standard Deviation|Mean
2608473|NCT02076919|Secondary|The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [Mass x Time/Volume] (AUClast), Part 2|Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.|Up to Day 15|This analysis population includes all enrolled subjects in Part 2.|||ng*h/mL||Standard Deviation|Mean
2608474|NCT02076919|Secondary|The Time to Reach the Maximum Concentration After Drug Administration [Time] (Tmax), Part 2|Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.|Up to Day 15|This analysis population includes all enrolled subjects in Part 2.|||hour||Standard Deviation|Mean
2608475|NCT02076919|Secondary|The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration [Mass / Volume] (Cmax), Part 2|Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method.Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.|Up to Day 15|This analysis population includes all enrolled subjects in Part 2.|||ng/mL||Standard Deviation|Mean
2608476|NCT02076919|Primary|Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 2|A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.|From time of consent until 30 days after stopping the trial/study drug|This analysis population includes all enrolled subjects in Part 2.|||participants|||Number
2608477|NCT02076919|Primary|Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 1|A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.|From time of consent until 30 days after stopping the trial/study drug|This analysis population includes all enrolled subjects in Part 1.|||participants|||Number
2608478|NCT02076776|Other Pre-specified|The Stroke Impact Scale (SIS)|This is a self-reported questionnaire evaluating quality of life. Normalized Hand Function is reported, scores range from 0-100, with higher scores indicating a better outcome.|Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)||||units on a scale||Standard Deviation|Mean
2608479|NCT02076776|Secondary|The Fugl-Meyer Assessment (FMA)|This is a 33 item assessment of post-stroke UE impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.|Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)||||units on a scale||Standard Deviation|Mean
2608480|NCT02076776|Primary|Wolf Motor Function Test (WMFT)|This consists of 2 strength tasks and 15 timed tasks of both the affected UE and the unaffected UE. Total Functional Ability Score is reported, scores range from 0-75, with higher scores indicating a better outcome.|Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)||||units on a scale||Standard Deviation|Mean
2609322|NCT02067039|Primary|Frequency of HIV Testing by Internet-recruited MSM.|Frequency of HIV testing >=3 times reported by participants over a 12-month follow-up period.|12 months|percent of MSM who reported testing at least three times over the course of the RCT|||Participants|||Count of Participants
2608482|NCT02076425|Secondary|Preschool Feelings Checklist-Scale Version (PFC-Scale) Score|The Preschool Feelings Checklist - Scale Version (PFC-Scale), was adapted from the PFC, which is a validated screening checklist used to capture young children at high risk for MDD. The PFC-Scale is a 23-item Likert scale with possible values of 0, 1, 2, 3, or 4 for each item. The total score is a sum of the 23 items, so the range of possible values is 0-92, with 92 being the most severe score possible.|completion of therapy (average of 20 weeks)||||units on a scale||Standard Deviation|Mean
2608483|NCT02076425|Primary|Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (KSADS-EC) MDD Core Symptom Score|The Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (K-SADS-EC) is a semi-structured clinical interview for DSM-5 disorders adapted for use in children aged 3-6. The MDD core symptom score was the number of core MDD symptoms endorsed on the K-SADS-EC. These 9 symptoms were (1) depressed mood, (2) anhedonia, (3) insomnia/hypersomnia, (4) fatigue, (5) decreased concentration, (6) weight/appetite change, (7) psychomotor agitation/retardation, (8) worthlessness/guilt, (9) suicidal thoughts/behaviors. The range of possible values is 0-9, with 9 being the worst outcome.|completion of therapy (average of 20 weeks)||||number of symptoms (0-9)||Standard Deviation|Mean
2608484|NCT02076412|Secondary|Frequency and Severity of Bleeding According to the World Health Organization (WHO) Bleeding Scale|"The World Health Organization (WHO) bleeding scale is a standardized grading scale created to measure the severity of bleeding. The scale is a clinical investigator-assessed five-point scale with a score range starting at the lowest 0=No bleeding, 1 = Petechiae, 2=Mild blood loss, 3=Gross blood loss, to the worse 4=Debilitating blood loss. The WHO bleeding scale is scored by history over the previous-week or by exam. After each grade is scored, the mean value is calculated (lowest score being 0 [no bleeding] to the highest score being 4 [debilitating blood loss]) for each visit. LOCF method was used to impute any missing data.~The mean of the WHO bleeding scale across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint."|Baseline to Week 24||||scores on a scale||Standard Deviation|Mean
2608485|NCT02076412|Secondary|Frequency and Severity of Bleeding According to the ITP Bleeding Score (IBLS)|"The ITP Bleeding Scale (IBLS) is an immune thrombocytopenic purpura (ITP)-specific bleeding score used to analyze the correlation of clinical and laboratory platelet variables with bleeding. The IBLS comprises of 11 grades from 0 (none) to 2 (marked bleeding) by history over the previous week or by exam; 2 being worse. These 11 grades include: skin by physical exam, oral by physical exam, skin by history, oral by history, epistaxis, gastrointestinal, urinary, gynecological, pulmonary, intracranial hemorrhage, and subconjunctival hemorrhage. After each grade is scored, the mean value for all 11 grades is calculated (lowest score being 0 and highest score being 2) for each subject visit. LOCF method was used to impute any missing data.~The mean of the IBLS scores across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint."|Baseline to Week 24||||scores on a scale||Standard Deviation|Mean
2608486|NCT02076412|Secondary|Number of Participants With Platelet Count ≥ 30,000/μL and at Least 20,000/μL Above Baseline at Week 24|Among subjects with a baseline platelet count < 15,000/μL, achievement of a count ≥ 30,000/μL and at least 20,000/μL above baseline at Week 24|Baseline to Week 24||||Participants|||Count of Participants
2608487|NCT02076412|Secondary|Number of Participants With Platelet Count ≥ 30,000/μL and at Least 20,000/μL Above Baseline at Week 12|Among subjects with a baseline platelet count < 15,000/μL, achievement of a count ≥ 30,000/μL and at least 20,000/μL above baseline at Week 12.|Baseline to Week 12||||Participants|||Count of Participants
2608488|NCT02076412|Secondary|Number of Participants With Platelet Count ≥ 50,000/µL at Week 24|Platelet Count ≥ 50,000/µL at Week 24|Baseline to Week 24||||Participants|||Count of Participants
2608489|NCT02076412|Secondary|Number of Participants With Platelet Count ≥ 50,000/µL at Week 12|Platelet Count ≥ 50,000/µL at Week 12|Baseline to Week 12||||Participants|||Count of Participants
2608490|NCT02076412|Primary|Number of Participants With Stable Platelet Response of at Least 50,000/µL|Stable platelet response by Week 24 defined as a platelet count of at least 50,000/µL on at least 4 of the 6 visits between Weeks 14-24|Baseline to Week 24||||Participants|||Count of Participants
2608491|NCT02076399|Secondary|Mean of World Health Organization (WHO) Bleeding Scale|"The World Health Organization (WHO) bleeding scale is a standardized grading scale created to measure the severity of bleeding. The scale is a clinical investigator-assessed five-point scale with a score range starting at the lowest 0=No bleeding, 1 = Petechiae, 2=Mild blood loss, 3=Gross blood loss, to the worse 4=Debilitating blood loss. The WHO bleeding scale is scored by history over the previous-week or by exam. After each grade is scored, the mean value is calculated (lowest score being 0 [no bleeding] to the highest score being 4 [debilitating blood loss]) for each visit. LOCF method was used to impute any missing data.~The mean of the WHO bleeding scale across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint."|Assessed over the 24-week study period||||scores on a scale||Standard Deviation|Mean
2608492|NCT02076399|Secondary|Mean of the ITP Bleeding Score (IBLS)|"The ITP Bleeding Scale (IBLS) is an immune thrombocytopenic purpura (ITP)-specific bleeding score used to analyze the correlation of clinical and laboratory platelet variables with bleeding. The IBLS comprises of 11 grades from 0 (none) to 2 (marked bleeding) by history over the previous week or by exam; 2 being worse. These 11 grades include: skin by physical exam, oral by physical exam, skin by history, oral by history, epistaxis, gastrointestinal, urinary, gynecological, pulmonary, intracranial hemorrhage, and subconjunctival hemorrhage. After each grade is scored, the mean value for all 11 grades is calculated (lowest score being 0 and highest score being 2) for each subject visit. LOCF method was used to impute any missing data.~The mean of the IBLS scores across visits during the 24-week treatment period was summarized by treatment group using descriptive statistics. A 2-sided, 2-sample t-test was used to test for a difference in means between treatments for this endpoint."|Assessed over the 24-week study period||||scores on a scale||Standard Deviation|Mean
2608493|NCT02076399|Secondary|Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 24.|Number of subjects with baseline platelet count <15,000/μL who showed platelet count increase to ≥30,000/μL and ≥20,000/μL from baseline count at Week 24.|Baseline to Week 24||||Participants|||Count of Participants
2608494|NCT02076399|Secondary|Platelet Count ≥ 30,000/μL and ≥ 20,000/μL Above Baseline in Subjects With Baseline Platelet Count of <15,000/μL at Week 12.|Number of subjects with baseline platelet count <15,000/μL who showed platelet count increase to ≥30,000/μL and ≥20,000/μL from baseline count at Week 12.|Baseline to Week 12||||Participants|||Count of Participants
2608495|NCT02076399|Secondary|Number of Participants With Platelet Count ≥ 50,000/µL at Week 24|Platelet Count ≥ 50,000/µL at Week 24|Week 24||||Participants|||Count of Participants
2608496|NCT02076399|Secondary|Number of Participants With Platelet Count ≥ 50,000/µL at Week 12|Platelet Count ≥ 50,000/µL at Week 12|Week 12||||Participants|||Count of Participants
2608497|NCT02076399|Primary|Number of Participants With Stable Platelet Response (Count of ≥50,000/µL on at Least 4 of the Last 6 Scheduled Visits Between Weeks 14 and 24)|A stable platelet response by Week 24 defined as a platelet count of at least 50,000/μL on at least 4 of the last 6 scheduled visits between Weeks 14 and 24|From Week 14 to Week 24||||Participants|||Count of Participants
2608498|NCT02076334|Secondary|Creatine Kinase||baseline, 24 hrs and 48 hrs post||||u/L||Standard Error|Mean
2608499|NCT02076334|Primary|Maximal Voluntary Contraction (MVC)||up to 72 hours||||Newton-meters||Standard Deviation|Mean
2608500|NCT02076321|Primary|Compare the Time to Union of Fractures and Osteotomies in Skeletally Immature Patients Administered NSAIDs for Pain Control, Versus Those Administered Acetaminophen for Pain Control.||The subject will be enrolled/assessed up to 6 months post-injury/osteotomy.||||Days||Full Range|Mean
2608501|NCT02076243|Secondary|Safety and Tolerability|number of participants with adverse events as a measure of safety and tolerability|up to 5 years||||Participants|||Count of Participants
2608502|NCT02076243|Secondary|Treatment Response|correlation of response to first line treatment with Nab-Paclitaxel with SPARC expression, with target lesions measured at the longest diameter of each non-lymph node lesion and the short axis for target lymph nodes|at week 8 post treatment|study terminated, results not collected||||||
2608503|NCT02076243|Secondary|Prevalence of SPARC Expression|prevalence of SPARC expression in advanced squamous cell cancer of the skin. The tumor specimen used to determine SPARC expression wll be obtained from a biopsy previously performed as standard of care (such as to establish the diagnosis).|at baseline|study terminated, results not collected||||||
2608504|NCT02076243|Secondary|Median Progression Free Survival|every eight weeks will reassess efficacy by imaging and can continue treatment if no progression and expect will be up to an average 5 years|average 5 years|study terminated, results not collected||||||
2608505|NCT02076243|Primary|Response Rate|the percentage of subjects who develop Complete Response (CR) or Partial Response (PR)|at week 8 post treatment|study terminated, results not collected||||||
2608506|NCT02076178|Secondary|Number of Participants Who Experienced Maximum Clinical Chemistry Including Liver Chemistry and Hematology Toxicities in the Oral Phase by Grades|The severity of clinical chemistry including liver chemistry and hematology toxicities was graded according to the DAIDS table for grading the severity of adult and pediatric AE Version 1.0, December 2004; Clarification August 2009. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening. Data for maximum clinical chemistry and hematology toxicities for oral phase (Day 1 upto Week 4) by grades have been presented.|Up to Week 4|Safety population.|||Participants|||Count of Participants
2608507|NCT02076178|Secondary|Number of Participants Who Received Concurrent Medication in Overall Study Duration|The concurrent medications that were consumed by participants during the injection phase were of the class nervous system, musculo-skeletal system, genito-urinary systems and sex hormones, various, respiratory system, dermatologicals, alimentary tract and metabolism, anti-infectives for systemic use, sensory organs, systemic hormonal preparations excluding sex hormones, blood and blood forming organs, cardiovascular system, anti-neoplastic and immunomodulating agents, anti-parasitic products, insecticides and repellents . The participants who took medication from any of the above class of during the during the overall study duration injection phase (Day 1 until Week 41) have been presented.|Up to Week 41|The Randomized Population comprised of all participants who met study criteria were randomly assigned to treatment in the study with the exception of any participants with documented evidence of not having consumed any amount of study medication.|||Participants|||Count of Participants
2608508|NCT02076178|Secondary|Number of Participants With AE, Grade 2-4 AE and Serious Adverse Events (SAE) in the Oral Phase|Clinical AE were graded using the DAIDS table for grading the severity of adult and pediatric AE Version 1.0, December 2004; Clarification August 2009. The grades were: 1 (mild)=Symptoms causing no or minimal interference with usual social and functional activities; 2 (moderate)= Symptoms causing greater than minimal interference with usual social and functional activities; 3 (severe)= Symptoms causing inability to perform usual social and functional activities; 4 (potentially life threatening): Symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Data has been presented for any Grade 2 or higher event in the injection phase for injection phase (Week 5- Week 41).|Up to Week 4|Safety population.|||Participants|||Count of Participants
2608509|NCT02076178|Secondary|Number of Participants With Severity of ISRs and ISR Symptoms for Injection Phase Defined by Grades and Needle Length|Acceptability of cabetogravir injections was assessed number of participants who had severe ISRs and ISR symptom. ISR examination for severity included an assessment of pain, pruritis, warm to touch, bruising, discoloration, erythema, swelling, induration and bump events. Common ISR Symptoms for Injection Phase included pain, erythema, nodules and any other ISRs with greater or equal to five participants. Data has been presented for the injection phase (W5-W41) by grades and needle length.|Up to Week 41|Safety injection population.|||Participants|||Count of Participants
2608517|NCT02076178|Primary|Change From Baseline in Vital Sign Assessment for Heart Rate (HR) in the Injection Phase|Vital signs measurements were performed for HR following 5 minutes of rest. Baseline was defined as the first injection at Week 5 for the injection phase. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value at Week 17, Week 29 and Week 41.|Baseline (Week 5) to Week 41|Safety population. Only those participants available at the specified time points were analyzed.|||beats per minute||Standard Deviation|Mean
2608510|NCT02076178|Secondary|Plasma Pharmacokinetic Assessment for Tmax and t½ by Demographic Factor BMI and Needle Length in the Injection Phase|The median BMI was 26 kilogram per meter square. Plasma pharmacokinetic assessments were performed for tmax and t½ by BMI, either above or below the median BMI (50 percent upper and lower, where upper summary included all participants with BMI greater than or equal to the median BMI of the population and lower summary included all participants with BMI below the median BMI). Assessments was also performed for tmax and t½ by needle length (1.5 inch and 2 inch). Needle length and BMI were correlated in that the longer needle was recommended for participants with BMI greater than 30 kilogram per meter square.|Up to Week 41|Pharmacokinetic parameter population. Only those participants available at the specified time point were analyzed.|||Days||Standard Deviation|Mean
2608511|NCT02076178|Secondary|Plasma Pharmacokinetic Assessment for Ctau and Cmax by Demographic Factor BMI and Needle Length in the Injection Phase|"The median BMI was 26 kilogram per meter square. Plasma pharmacokinetic assessments were performed for Ctau and Cmax by BMI, either above or below the median BMI (50 percent upper and lower, where upper summary included all participants with BMI greater than or equal to the median BMI of the population and lower summary included all participants with BMI below the median BMI.~). Assessments was also performed for Ctau and Cmax by needle length (1.5 inch and 2 inch). Needle length and BMI were correlated in that the longer needle was recommended for participants with BMI greater than 30 kilogram per meter square."|Up to Week 41|Pharmacokinetic parameter population. Only those participants available at the specified time point were analyzed.|||micrograms per milliter||Geometric Coefficient of Variation|Geometric Mean
2608512|NCT02076178|Secondary|Plasma Pharmacokinetic Assessment for AUC(0-tau) by Demographic Factor Body Mass Index (BMI) and Needle Length in the Injection Phase|The median BMI was 26 kilogram per meter square. Plasma pharmacokinetic assessments were performed for AUC (0-tau) by BMI, either above or below the median BMI (50 percent upper and lower, where upper summary included all participants with BMI greater than or equal to the median BMI of the population and lower summary included all participants with BMI below the median BMI). Assessments was also performed for AUC (0-tau) by needle length (1.5 inch and 2 inch). Needle length and BMI were correlated in that the longer needle was recommended for participants with BMI greater than 30 kilogram per meter square.|Up to Week 41|Pharmacokinetic parameter population. Only those participants available at the specified time point were analyzed.|||hour*microgram per milliter||Geometric Coefficient of Variation|Geometric Mean
2608513|NCT02076178|Secondary|Plasma Pharmacokinetic Assessment for Time to Maximum Observed Concentration (Tmax), Apparent Terminal Phase Half-life for (t½) in the Injection Phase|Blood samples for pharmacokinetic analysis were collected starting on the first day of the First Injection Phase prior to the injection. At each injection visit a blood sample was collected prior to the injection at Week 5, Week 17 and Week 29, 1 Week post-injection at Week 6, Week 18, and Week 30, and 12 Week post-injection at Week 17, Week 29, and Week 41. The sample collected 12 Week following each injection served as the pre-dose sample for the subsequent dosing interval. Two additional samples were collected 4 and 8 Week after the first injection (Week 9 and Week 13), and 1 additional sample was collected 6 Week following the second and third injections (Week 23 and Week 35). Assessment was carried out for tmax defined as the time to the maximum observed plasma concentration and t½ defined as the time taken for the concentration of drug in the blood to decrease by half of the original amount.|Up to Week 41|Pharmacokinetic parameter population. Only those participants available at the specified time points were analyzed.|||days||Standard Deviation|Mean
2608514|NCT02076178|Secondary|Plasma Pharmacokinetic Assessment for Concentration at the End of the Dosing Interval (Ctau) and Maximum Observed Concentration (Cmax) in the Injection Phase|Blood samples for pharmacokinetic analysis were collected starting on the first day of the First Injection Phase prior to the injection. At each injection visit a blood sample was collected prior to the injection at Week 5, Week 17 and Week 29, 1 Week post-injection at Week 6, Week 18, and Week 30, and 12 Week post-injection at Week 17, Week 29, and Week 41. The sample collected 12 Week following each injection served as the pre-dose sample for the subsequent dosing interval. Two additional samples were collected 4 and 8 Week after the first injection (Week 9 and Week 13), and 1 additional sample was collected 6 Week following the second and third injections (Week 23 and Week 35). Assessment was carried out for Ctau defined as the concentration at the end of the dosing interval and Cmax defined as the maximum observed plasma concentration.|Up to Week 41|Pharmacokinetic parameter population. Only those participants available at the specified time points were analyzed.|||micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2608515|NCT02076178|Secondary|Plasma Pharmacokinetic Assessment for Area Under the Plasma Concentration-time Curve Over the Dosing Interval [AUC(0-tau)] in the Injection Phase|Blood samples for pharmacokinetic analysis were collected starting on the first day of the First Injection Phase prior to the injection. At each injection visit a blood sample was collected prior to the injection at Week 5, Week 17 and Week 29, 1 Week post-injection at Week 6, Week 18, and Week 30, and 12 Week post-injection at Week 17, Week 29, and Week 41. The sample collected 12 Week following each injection served as the pre-dose sample for the subsequent dosing interval. Two additional samples were collected 4 and 8 Week after the first injection (Week 9 and Week 13), and 1 additional sample was collected 6 Week following the second and third injections (Week 23 and Week 35). Assessment was carried out for AUC(0-tau) a measure of the amount of drug available at target tissue (in plasma) for a fixed dosing interval (i.e.12 hours).|Up to Week 41|The pharmacokinetic parameter population comprised of all participants who underwent plasma pharmacokinetic sampling and have evaluable cabotegravir parameters estimated. Only those participants available at the specified time points were analyzed.|||hour*microgram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2608516|NCT02076178|Primary|Number of Participant With ISR for the Injection Phase Defined by Maximum Grades|Common ISR included pain, erythema, nodules and any other ISR with greater or equal to 5 participants. The number of participants who experienced pain events by needle length, swelling events by needle length, bump events by needle length for injection phase by maximum grades have been presented for the injection phase (Week 5-Week 41).|Up to Week 41|Safety Injection population.|||Participants|||Count of Participants
2608556|NCT02075840|Secondary|Tmax of Alectinib Metabolite||Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)|The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.|||hours||Full Range|Median
2608518|NCT02076178|Primary|Change From Baseline in Vital Sign Assessment for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Injection Phase|Vital signs measurements were performed for SBP and DBP following 5 minutes of rest. Baseline was defined as the first injection at Week 5 for the injection phase. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value at Week 17, Week 29 and Week 41.|Baseline (Week 5) to Week 41|Safety population. Only those participants available at the specified time points were analyzed.|||millimeters of mercury||Standard Deviation|Mean
2608519|NCT02076178|Primary|Number of Participants Who Had Abnormal Electrocardiogram (ECG) Findings in the Injection Phase|Full 12-lead ECGs included heart rate, PR, QRS, QT and QTc intervals. Measurements were taken from the participant following 5 minutes of rest in a semi-supine position. ECGs were performed at Week 5, Week 17, Week 29 and Week 41 in the injection phase (Week 5-Week 41). ECG abnormalities characterized as abnormal-not clinically significant (A-NCS) and abnormal-clinically significant (A-CS) upto Week 41 have been presented. There were no A-CS findings for ECG in the injection phase.|Up to Week 41|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2608520|NCT02076178|Primary|Number of Participants Who Experienced Grade 2 or Higher Laboratory Results in the Injection Phase|The severity of laboratory results was graded according to the DAIDS table for grading the severity of adult and pediatric AE Version 1.0, December 2004; Clarification August 2009. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening. Data for Number of participants who experienced grade 2 or higher laboratory results in the injection phase (Week 5-Week 14) have been presented.|Up to Week 41|Safety Injection population.|||Participants|||Count of Participants
2608521|NCT02076178|Primary|Number of Participants Who Recieved Injection Site Reaction (ISR) Related Concomitant Medication in the Injection Phase|The concurrent medications that were consumed by participants during the injection phase were of the class nervous system, musculo-skeletal system, genito urinary systems and sex hormones, various, respiratory system, dermatologicals, alimentary tract and metabolism, sensory organs, systemic hormonal preparations, excluding sex hormones, blood and blood forming organs, cardiovascular system. The participants who took medication from any of the above class of during the injection phase (Week 5-Week 41) have been presented.|Up to Week 41|The randomized population was defined as all participants who met the study criteria and were randomly assigned to treatment in the study.|||Participants|||Count of Participants
2608522|NCT02076178|Primary|Number of Participants With Any Grade 2 or Higher Event in the Injection Phase|Clinical adverse event (AE) were graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) table for grading the severity of adult and pediatric AE Version 1.0, December 2004; Clarification August 2009. The grades were: 1 (mild)=Symptoms causing no or minimal interference with usual social and functional activities; 2 (moderate)= Symptoms causing greater than minimal interference with usual social and functional activities; 3 (severe)= Symptoms causing inability to perform usual social and functional activities; 4 (potentially life threatening): Symptoms causing inability to perform basic self-care functions or medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. Data has been presented for any Grade 2 or higher event in the injection phase for injection phase (Week 5- Week 41).|Up to Week 41|Safety Injection population was defined as all participants enrolled in the study who received at least one injection of study medication.|||Participants|||Count of Participants
2608523|NCT02076165|Secondary|Change From Baseline to 3-month Follow-up in Insomnia Severity Index Score|Mean score on Insomnia Severity Index (ISI). This 7-item scale measures self-reported severity of insomnia symptoms. Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.|Baseline and 3-months from randomization||||score on a scale||Standard Error|Mean
2608524|NCT02076165|Secondary|Change From Baseline to Post-Treatment in Insomnia Severity Index Score|Mean score on Insomnia Severity Index (ISI). This 7-item scale measures self-reported severity of insomnia symptoms. Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.|Baseline and 1 week after the end of the 5-week intervention period||||score on a scale||Standard Error|Mean
2608525|NCT02076165|Secondary|Sleep Efficiency From Wrist Actigraphy at 3-month Follow-up|Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of wrist actigraphy.|3-months after randomization||||percentage of time asleep||Standard Error|Mean
2608526|NCT02076165|Secondary|Sleep Efficiency From Actigraphy at Post-Treatment|Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of wrist actigraphy.|1 week after the end of the 5-week intervention period||||percentage of time asleep||Standard Error|Mean
2608527|NCT02076165|Secondary|Sleep Efficiency From Sleep Diary at 3-month Follow-up|Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary.|3-months after randomization||||percentage of time asleep||Standard Error|Mean
2608528|NCT02076165|Secondary|Sleep Efficiency From Sleep Diary at Post-Treatment|Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary.|1 week after the end of the 5-week intervention period||||percentage of time asleep||Standard Error|Mean
2608529|NCT02076165|Primary|Non-adherence to Nighttime Stimulus Control|Average proportion of nights on which participant did not get out of bed if unable to sleep after 20 minutes awake.|Final 7-nights of the 5-week intervention period||||Proportion of nights||Standard Error|Mean
2608530|NCT02076165|Primary|Adherence to Rise Time Recommendations|Minutes deviation from recommended rise time during the final week of the intervention period|Final 7-nights of the 5-week intervention period||||minutes||Standard Error|Mean
2608531|NCT02076165|Primary|Adherence With Bedtime Recommendations|Minutes deviation from recommended bedtime recommendations during final week of intervention period.|Final 7 nights of the 5-week intervention period||||minutes||Standard Error|Mean
2608532|NCT02076165|Primary|Number of Participants Completing 5 Behavioral Treatment Sessions|Number of participants who attended and completed all 5 behavioral treatment sessions.|End of the 5-week behavioral treatment period||||Participants|||Count of Participants
2608709|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: AUClast; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
2608533|NCT02076100|Primary|Number of Participants Who Discontinued Study Drug Due To An AE|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to 5 days|All participants who received at least one dose of the investigational drug.|||Participants|||Count of Participants
2608534|NCT02076100|Primary|Number of Participants Who Experienced One or More Adverse Events (AEs)|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to 61 days|All participants who received at least one dose of the investigational drug.|||Participants|||Count of Participants
2608535|NCT02076100|Primary|Maximum log10 HCV Ribonucleic Acid (RNA) Change From Baseline|Blood was collected at baseline and on Days 1, 2, 3, 4 and 5 to determine HCV RNA levels. Least squares means (LSM) and confidence intervals (CI) were obtained from an analysis of variance (ANOVA) model with maximum log10 HCV RNA change from baseline as response and a fixed effect for treatment. The primary hypothesis was that the mean change from baseline would be a reduction of ≥3 log10. A positive change from baseline indicates a reduction from baseline in log10 HCV RNA.|Baseline and up to Day 5|Participants who complied with the protocol sufficiently to ensure that generated data would exhibit the effects of treatment, according to the underlying scientific model. Compliance covers considerations such as exposure to treatment, availability of measurements and absence of major protocol violations.|||log10 IU/mL||90% Confidence Interval|Least Squares Mean
2608536|NCT02076022|Secondary|Number of Participants With Clinically Significant Levels of Depression on the Patient Health Questionnaire-9 (PHQ-9)|Measure quality of life in patients before and after autologous fat grafting using validated psychosocial measures. This will evaluate using instruments designed for assessing depression including the Patient Health Questionnaire-9 (PHQ-9) which is a tool to screen, diagnose, monitor, and measure the severity of depression.|2 years||||Participants|||Count of Participants
2608537|NCT02076022|Secondary|Cell Yield|To assess biologic properties of the cells within the fat graft, we evaluated adipose stem cell viability by multiparameter flow cytometry.|day 0|participant discrepancy due to subject withdrawal from study|||percent||Standard Deviation|Mean
2608538|NCT02076022|Primary|Efficacy of Autologous Fat Transfer at Pain Modulation at Respective Amputation Sites|"Assess the efficacy of minimally invasive autologous fat transfer at the amputation sites and the modulation of pain at the respective sites~Compare two minimally invasive techniques as an alternative to invasive operations, with the understanding that this therapy does not preclude more invasive procedures in the future. We further hypothesize that enriching the fat graft with autologous adipose stromal cells utilizing the Tissue Genesis Cell Isolation System (CIS), a regenerative medicine approach, will lead to improved retention of the fat graft over time and result in a more favorable outcome.~Subjects reported pain on a scale of 0-5 where 5 was the worst pain and 0 was no pain."|2 years||||score on a scale||Standard Deviation|Mean
2608539|NCT02076009|Secondary|Duration of Response (DOR)|DOR was defined for participants with confirmed response (PR or better) as time between first documentation of response and disease progression/death due to PD, whichever occurs first. PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10mg/dL; Definite increase in size of existing bone lesions/soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5mg/dL) that can be attributed solely to PC proliferative disorder.|From randomization to the date of first documented evidence of PD until 3 years|Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment. Here 'N' signifies number of participants who had PR or better response.|||months||95% Confidence Interval|Median
2608540|NCT02076009|Secondary|Time to Response|Time to response was defined as the time between the date of randomization and the first efficacy evaluation that the participant met all criteria for partial response (PR) or better.|From randomization up to first documented CR or PR until 3 years|Response-evaluable set is defined as participants who have a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit. In addition, participants must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.|||months||95% Confidence Interval|Median
2608541|NCT02076009|Secondary|Overall Survival (OS)|Overall survival was measured from the date of randomization to the date of the participant's death.|Up to approximately 5 years (anticipated) after the last participant is randomized|ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.|||months||95% Confidence Interval|Median
2608557|NCT02075840|Secondary|Cmax of Alectinib Metabolite||Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)|The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2608542|NCT02076009|Secondary|Overall Response Rate|Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria, during or after study treatment. IMWG criteria for PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.|From randomization to disease progression (approximately up to 3 years)|Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.|||percentage of participants|||Number
2608543|NCT02076009|Secondary|Percentage of Participants With Negative Minimal Residual Disease (MRD)|Minimal residual disease was assessed for all participants who achieved a complete response (CR) or stringent complete response (sCR). The MRD negativity rate was defined as the percentage of participants who had negative MRD assessment at any time point after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10^- 4 threshold.|From randomization to the date of first documented evidence of PD until 3 years|ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.|||percentage of participants|||Number
2608544|NCT02076009|Secondary|Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better|VGPR or better is defined as the percentage of participants who achieved VGPR, complete response (CR) and stringent complete response (sCR) according to the International Myeloma Working Group criteria (IMWG). IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.|From randomization to disease progression (approximately up to 3 years)|Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2608545|NCT02076009|Secondary|Time to Disease Progression (TTP)|TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5 g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be >10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to Plasma Cell (PC) proliferative disorder.|From randomization to disease progression until 3 years|ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.|||months||95% Confidence Interval|Median
2608546|NCT02076009|Primary|Progression-free Survival (PFS)|PFS was defined as duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD was defined as meeting any one of following criteria: Increase of greater than equal to (>=)25 percent (%) in level of serum M-protein from lowest response value and absolute increase must be >=0.5 gram per deciliter (g/dL); Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.|From randomization to either disease progression or death whichever occurs first until 3 years|Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to the daratumumab, lenalidomide, dexamethasone (DRd) or lenalidomide, low-dose dexamethasone (Rd) group.|||months||95% Confidence Interval|Median
2608547|NCT02075840|Secondary|HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Arm and Shoulder|The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.|Baseline, every 4 weeks until disease progression (up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points.|||Score on a scale||Full Range|Median
2608548|NCT02075840|Secondary|HRQoL by EORTC Quality of Life Questionnaire LC13 Score Pain in Chest|The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.|Baseline, every 4 weeks until disease progression (up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points.|||Score on a scale||Full Range|Median
2608549|NCT02075840|Secondary|HRQoL by EORTC Quality of Life Questionnaire LC13 Score Dyspnoea|The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.|Baseline, every 4 weeks until disease progression (up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points.|||Score on a scale||Full Range|Median
2608550|NCT02075840|Secondary|HRQoL by EORTC Quality of Life Questionnaire LC13 Score Coughing|The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.|Baseline, every 4 weeks until disease progression (up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points.|||Score on a scale||Full Range|Median
2608551|NCT02075840|Secondary|Health-Related Quality of Life (HRQoL) by EORTC Quality of Life Questionnaire C30 Score|The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.|Baseline, every 4 weeks until disease progression (up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants evaluated for specified time points.|||Score on a scale||Full Range|Median
2608552|NCT02075840|Secondary|Percentage of Participants With Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13)|The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a >or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point increase above baseline followed by death within 5 weeks from the last assessment.|Baseline, every 4 weeks until disease progression (up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2608553|NCT02075840|Secondary|Time to Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13)|The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a >or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point increase above baseline followed by death within 5 weeks from the last assessment.|Baseline, every 4 weeks until disease progression (up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2608554|NCT02075840|Secondary|Percentage of Participants With Deterioration by EORTC Quality Of Life Questionnaire Core 30 (C30)|The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a >or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point decrease from baseline followed by death within 5 weeks from the last assessment.|Baseline, every 4 weeks until disease progression (up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2608555|NCT02075840|Secondary|Time to Deterioration by European Organization for The Research And Treatment of Cancer (EORTC) Quality Of Life Questionnaire Core 30 (C30)|The EORTC QLQ-30 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in global health status or function is defined as a >or=10-point decrease from baseline in a symptom score that must be held for at least two consecutive assessments or an initial >or=10-point decrease from baseline followed by death within 5 weeks from the last assessment.|Baseline, every 4 weeks until disease progression (up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2608558|NCT02075840|Secondary|AUC of Alectinib Metabolite||Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months)|The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2608559|NCT02075840|Secondary|Time to Reach Cmax (Tmax) of Alectinib||Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)|The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.|||hours||Full Range|Median
2608560|NCT02075840|Secondary|Maximum Concentration (Cmax) of Alectinib||Pre-dose (within 2 hours before alectinib), 1, 2, 4, 6, and 8 hours post-dose at baseline and Week 4; Pre-dose (within 2 hours before alectinib) at Week 8, then every 8 weeks until disease progression or death/withdrawal from study (up to 33 months)|The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2608561|NCT02075840|Secondary|Area Under The Concentration-Time Curve (AUC) of Alectinib||Pre-dose (within 2 hours before alectinib) (baseline), 1, 2, 4, 6, and 8 hours post-dose at Visit 0 (first dosing day) and Week 4; Pre-dose (within 2 hours) at Week 8, then every 8 weeks until disease progression or death/withdrawal (up to 33 months)|The Pharmacokinetic (PK) Evaluable Population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2608562|NCT02075840|Secondary|Percentage of Participants With Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline up to 28 months in the crizotinib arm and up to 30 months in the alectinib arm|Safety (SAF) population included all participants who received at least one dose of any study drug.|||Percentage of Participants|||Number
2608563|NCT02075840|Secondary|CNS DOR IRC-assessed According to RECIST v1.1 Criteria|CNS DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.|First occurrence of CNS objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants with a BOR of CR or PR.|||months||95% Confidence Interval|Median
2608564|NCT02075840|Secondary|Percentage of Participants With CNS ORR of CR or PR IRC-assessed According to RECIST v1.1 Criteria|CNS ORR was defined as the percentage of participants who attained CR or PR and had measurable/non-measurable CNS lesions at baseline. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure (number of participants with measurable/non-measurable CNS lesions at baseline).|||Percentage of Participants||95% Confidence Interval|Number
2608565|NCT02075840|Secondary|Percentage of Participants With OS Event|Overall survival (OS) was defined as the time from randomization to death from any cause.|From randomization until death (up to 43 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2608566|NCT02075840|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from randomization to death from any cause.|From randomization until death (up to 43 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2608567|NCT02075840|Secondary|Duration of Response (DOR) According to RECIST V1.1 Criteria as Assessed by the Investigators|DOR was defined as the time from when response (CR or PR) was first documented to first documented disease progression or death, whichever occurred first. DOR was evaluated for participants who had a best overall response (BOR) of CR or PR.|First occurrence of objective response to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)|ITT population included all participants randomized in the study, irrespective of whether or not they received study drug. Number analyzed indicates number of participants with a BOR of CR or PR.|||Months||95% Confidence Interval|Median
2608568|NCT02075840|Secondary|Percentage of Participants With Objective Response Rate (ORR) of Complete Response (CR) or Partial Response (PR) as Determined by The Investigators According to RECIST V1.1 Criteria|ORR was defined as the percentage of participants who attained CR or PR. As per RECIST v1.1, CR: Disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm, PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
2608604|NCT02075541|Primary|Number of Subjects With Any Solicited General AEs|Assessed solicited general symptoms are fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, fever (defined as oral temperature equal to or above 37.5 °C). Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (from Day 60 to Day 66) following the second dose.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
2608569|NCT02075840|Secondary|Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using Revised Assessment in Neuro Oncology (RANO) Criteria|CNS progression was assessed as percentage of participants with event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib.|Randomization to the first occurrence of disease progression in the CNS (assessed every 8 weeks up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2608570|NCT02075840|Secondary|Percentage of Participants With Central Nervous System (CNS) Progression as Determined by IRC Using RECIST V1.1 Criteria|CNS progression was assessed as percentage of participants with an event defined as time from randomization until first radiographic evidence of CNS progression by IRC. The risk for a CNS progression without a prior non-CNS progression with alectinib compared with crizotinib.|Randomization to CNS PD as first occurrence of disease progression (assessed every 8 weeks up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2608571|NCT02075840|Secondary|Percentage of Participants With PFS Event by IRC|PFS was assessed as percentage of participants with disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.|Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2608572|NCT02075840|Secondary|PFS Independent Review Committee (IRC)-Assessed|PFS was assessed as time to disease progression or death whichever occurred first by IRC assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 mm and the appearance of new lesions.|Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2608573|NCT02075840|Primary|Percentage of Participants With PFS Event by Investigator Assessment|PFS was assessed percentage of participants with disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.|Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2608574|NCT02075840|Primary|Progression-Free Survival (PFS) by Investigator Assessment|PFS was assessed as time to disease progression or death whichever occurred first by investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) Criteria. As per RECIST v1.1, disease progression is a 20% increase in the sum of the diameters of target lesions, an increase in size of measurable lesions by at least 5 millimeter (mm) and the appearance of new lesions.|Randomization to first documented disease progression or death, whichever occurs first (assessed every 8 weeks up to 33 months)|ITT population included all randomized participants in the study. Number of participants analyzed is the total participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2608575|NCT02075658|Secondary|Improvement in Cardiac Output With the AirSeal Device.|"Assuming cardiac output of approximately 5.0 L/min with the conventional device, we will have 96% power to detect as significant an improvement in cardiac output to 5.5 L/min using a two-group Satterwaite t-test and assuming variance of 0.25.~Cardiac out put is defined by the volume of blood pumped by the heart in a given amount of time."|Day 1 (Day of Procedure)||||volume per minute||Standard Deviation|Mean
2608576|NCT02075658|Primary|AirSeal Reduction in the Variance of Intra-abdominal Pressure|Our primary aim is to show reduction in the variance of intra-abdominal pressure throughout the operative procedure when using the AirSeal device compared to a conventional insufflator. Based on preliminary data, we assume pressures maintained at a mean of 15 through out surgery for both devices and a variance of 3.6 with the conventional insufflator.|Day 1 (Day of Procedure)||||mmHg||Standard Deviation|Mean
2608577|NCT02075632|Secondary|Number of Days of Use|The number of days subjects used the study medication was summarized for all subjects and by cohort in evaluable subjects.|Day 1-Day 14|A subject was evaluable for summaries of number of days of use, if he or she used the study medication at least once and provided use information at Visit 2. Data for 4 subjects was not available for this analysis.|||Days||Standard Deviation|Mean
2608578|NCT02075632|Secondary|Number of Times Per Day Participants Used the Product|The number of study medication applications, was summarized for all subjects and by cohort in evaluable subjects.|Day1-Day14|A subject was evaluable for average number of applications per day and maximum number of applications per day if he or she used the study medication at least once and provided use information at Visit 2. Data for four subjects was not available for this analysis.|||Applications||Standard Deviation|Mean
2608579|NCT02075632|Primary|Number of Participants With Incorrect Duration of Use of the Medication|Incorrect duration of use was defined as the use of study medication for more than 7 consecutive days and/or more than three times in a day. Participants were asked the reasons of doing so and they were allowed to select multiple reasons also, if applicable.|Day1-Day 14|A participant was evaluable for analysis of the rate of incorrect use if he or she used the study medication at least once and provided use information at least 8 days after the enrollment visit.|||Participants|||Number
2608580|NCT02075606|Secondary|Percentage of Subjects Alive and Progression Free at One Year|"Subjects underwent CT or MRI scans at baseline and Week 53. Progression was assessed by investigators using RECIST v1.1. The best overall response to study treatment is the highest time point response achieved by the subject and was assessed as a complete response, partial response, stable disease, progressive disease or non evaluable. For analysis of PFS, event dates were assigned to the first time that progressive disease was noted or the date of death. In case of progressive disease followed by death, the first event was considered in the analysis. Censoring dates were defined in subjects with no progressive disease or death before end of study.~At one year (end of study), the mean percentage of subjects who were alive and progression free, as calculated using the Kaplan-Meier method, is reported by CTC presence and overall."|From baseline up to Week 53.|Analysis was performed on the ITT population, defined as all enrolled subjects who received at least one injection of study medication. Only subjects with data available for analysis are presented.|||percentage of subjects||95% Confidence Interval|Mean
2608581|NCT02075606|Secondary|QoL Questionnaire: EORTC QLQ-G.I.NET21|The effect of lanreotide Autogel treatment on QoL was assessed using the EORTC QLQ-G.I.NET21 at baseline, Weeks 13 (Visit 5), 25 (Visit 8) and 53 (Visit 15/end of study). The QLQ-G.I.NET21 questionnaire contained 21 questions that used a 4-point scale (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much) to evaluate 3 defined multi-item symptom scales (endocrine, gastrointestinal and treatment related side effects), 2 single item symptoms (bone/muscle pain and concern about weight loss), 2 psychosocial scales (social function and disease-related worries) and 2 other single items (sexuality and communication). Each individual subscore was transformed to range from 0 to 100. Higher scores indicate worse symptoms or more problems. The mean change from baseline at each time point is reported for each of the category subscores.|From baseline up to Week 53.|Analysis was performed on the ITT population, defined as all enrolled subjects who received at least one injection of study medication. Only subjects with data available for analysis are presented.|||Units on a scale||Standard Deviation|Mean
2608582|NCT02075606|Secondary|Quality of Life (QoL) Questionnaire: European Organisation for Research and Treatment of Cancer (EORTC) QoL Questionnaire (QLQ)-C30|"The effect of lanreotide Autogel treatment on QoL was assessed using the EORTC QLQ-C30 at baseline, Weeks 13 (Visit 5), 25 (Visit 8) and 53 (Visit 15/end of study). The 30 item scale is divided into 9 multi item scales (including 5 functional scales, 1 global health status/QoL scale and 3 general symptom scales) and 6 single items. Possible answers to the first 28 items (all items except the 2 concerning global quality of life) go from 1 (Not at all) to 4 (Very much). The answers for the 2 last questions (Q29- 30) go from 1 (Very poor) to 7 (Excellent). All of the scales and single-item measures range in score from 0 to 100. For multi-item scales, the raw score will be calculated by the addition of item responses divided by the number of items. Higher scores for global health and functional domains indicate a better QoL, while higher symptom scores indicate worse symptoms.~The mean change from baseline at each time point is reported for each of the category subscores."|From baseline up to Week 53.|Analysis was performed on the ITT population, defined as all enrolled subjects who received at least one injection of study medication. Only subjects with data available for analysis are presented.|||Units on a scale||Standard Deviation|Mean
2608583|NCT02075606|Secondary|Mode Symptom Severity of Episodes of Flushing|The effect of lanreotide Autogel on the mode severity of flushing was assessed through subject reporting of symptoms every 24-hours for the 7 days prior to treatment (baseline), for the first 16 weeks and on days 11 to 17 after each subsequent injection interval until Week 49. After the final study drug injection at Week 49, subjects provided 24-hour symptom severity on days 11 to 28 (up to Week 53). Symptom severity was recorded by answering predetermined questions on the IVRS using a three-point system (mild, moderate or severe). The mode (most frequent) intensity of flushing are reported at baseline and at Visit 14 (average number of episodes over days 11 to 17 after Week 49 injection and over days 11 to 28 after Week 49 injection). Percentages of subjects in each severity category are based on the number of subjects in the analysis set with available responses. Data is presented according to CTC presence at baseline and overall.|From baseline up to Week 53.|Analysis was performed on the ITT population, defined as all enrolled subjects who received at least one injection of study medication. Only subjects with data available for analysis are presented.|||percentage of subjects||95% Confidence Interval|Number
2608584|NCT02075606|Secondary|Mean Change From Baseline in Number of Episodes of Diarrhoea and Flushing|"The effect of lanreotide Autogel on the symptoms of diarrhoea and flushing in subjects was assessed through subject reporting of symptoms every 24-hours for the 7 days prior to treatment (baseline), for the first 16 weeks and on days 11 to 17 after each subsequent injection interval. After the final study drug injection at Week 49, subjects provided 24-hour symptom frequency on days 11 to 28 (up to Week 53). Symptom frequency was recorded by answering predetermined questions on the IVRS.~Mean change from baseline in frequency (number of episodes) of diarrhoea and flushing are described at Visit 2 (average number of episodes in Week 1) and at Visit 14 (average number of episodes over days 11 to 17 after Week 49 injection and over days 11 to 28 after Week 49 injection) by CTC presence at baseline and overall. A negative change indicates an improvement in symptoms from baseline."|From baseline up to Week 53.|Analysis was performed on the ITT population, defined as all enrolled subjects who received at least one injection of study medication. Only subjects with data available for analysis at each time point are reported.|||number of episodes||95% Confidence Interval|Mean
2608585|NCT02075606|Primary|Percentage of Subjects With Time Point Responses According to Response Evaluation Criteria in Solid Tumours (RECIST) Assessments at Weeks 25 and 53|"Subjects underwent Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scans at baseline, Visit 8 (Week 25) and Visit 15 (Week 53). Progression was assessed by investigators using RECIST v1.1, and classified as a complete response, partial response, stable disease, progressive disease or non evaluable.~The time point responses at Week 25 and Week 53 were analysed by CTC presence at baseline and overall. The percentage of subjects within each response category are presented. Percentages are based on the number of subjects in the concerned population with available responses."|Week 25 and Week 53.|Analysis was performed on subjects from the ITT population, defined as all enrolled subjects who received at least one injection of study medication. Only subjects with data available for analysis are presented.|||percentage of subjects||95% Confidence Interval|Number
2608630|NCT02075463|Secondary|Reticulocyte Hgb Content (CHr) at Week 16|Data has been presented for only those participants who were available at indicated timepoints|Week 16|Safety population consisted of all participants who received at least one dose of study drug|||Picogram (pg)|||Number
2608586|NCT02075606|Primary|Assessment of Clinical Symptomatic Response|"This endpoint was assessed using 2 efficacy variables:~CTCs, enumerated at baseline and Weeks 5, 17, 25, 53~Clinical symptomatic response, assessed by the use of symptom reporting~Subjects recorded 24-hour symptom frequency and severity for 7 days prior to first treatment (baseline), throughout the study, and up to 28 days following final drug administration. Symptoms were recorded by answering predetermined questions on the interactive voice response system (IVRS).~Subjects were considered to have a clinical symptomatic response between baseline and last study visit if any 1 of the following criteria were fulfilled: the average number of episodes of diarrhoea decreased by at least 50%, the average number of episodes of flushing decreased by at least 50%, the mode severity of flushing decreased by at least 1 level. Clinical symptomatic response was assessed as a qualitative variable (Yes/No) and reported according to CTC presence at baseline and overall."|From baseline up to Week 53.|Analysis was performed on the Intention-to-treat (ITT) population, defined as all enrolled subjects who received at least one injection of study medication. Only subjects with data available for analysis are presented.|||Percentage of Subjects||95% Confidence Interval|Number
2608587|NCT02075541|Secondary|Frequency of Specific CD8+ T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response.|Frequency of specific CD8+ T-cells were measured by flow cytometry ICS expressing two or more markers (such as IL-2, IL-13, IL-17, IFN-γ, TNF-α and CD40L).The frequency of specific CD8+ T-cells are summarised [descriptive statistics: Mean and standard deviation (SD)] against each antigen (PD, PE and PilA), by group at each time point during which blood samples are collected for CMI.|At Day 0, Day 90, Day 270 and at Day 450.|Analysis was performed on a sub-cohort of participants from the ATP cohort for Immunogenicity, including approximately 40 subjects (20/each group), for which an additional blood sample was taken at the specified time points. The analysis was only performed on those subjects with available results for the analyzed outcome variable.|||CD8+ T-cells/ million cells||Standard Deviation|Mean
2608588|NCT02075541|Secondary|Frequency of Specific Cluster of Differentiation 4 (CD4+) T-cells Against NTHi Antigens Collected for Evaluation of Cell-mediated Immune Response.|Frequency of specific CD4+ T-cells were measured by flow cytometry intracellular cytokine staining (ICS) expressing two or more markers [such as Interleukin-2 (IL-2), IL-13, IL-17, Interferon-γ (IFN-γ), Tumor Necrosis Factor-α (TNF-α) and Cluster of Differentiation 40 Ligand (CD40L)].The frequency of specific CD4+ T-cells are summarised [descriptive statistics: Mean and standard deviation (SD)] against each antigen (PD, PE and PilA), by group at each time point during which blood samples are collected for CMI.|At Day 0, Day 90, Day 270 and at Day 450.|Analysis was performed on a sub-cohort of participants from the ATP cohort for Immunogenicity, including approximately 40 subjects (20/each group), for which an additional blood sample was taken at the specified time points. The analysis was only performed on those subjects with available results for the analyzed outcome variable.|||CD4+ T-cells/ million cells||Standard Deviation|Mean
2608589|NCT02075541|Secondary|Concentration of Anti-PilA Total IgG Antibodies Against the NTHi Vaccine Antigens.|Antibody concentrations were measured by ELISA and expressed as GMCs in EL.U/mL. The cut-off of the assay was 7 EL.U/mL for anti-PilA.|At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450.|Analysis was performed on the ATP cohort for Immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assigned and for whom post-vaccination immunogenicity results were available for at least 1 assay.|||El.U/mL||95% Confidence Interval|Geometric Mean
2608590|NCT02075541|Secondary|Concentration of Anti Protein E (Anti-PE) Total IgG Antibodies Against the NTHi Vaccine Antigens.|Antibody concentrations were measured by ELISA and expressed as GMCs in EL.U/mL. The cut-off of the assay was 8 EL.U/mL for anti-PE.|At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450|Analysis was performed on the ATP cohort for Immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assigned and for whom post-vaccination immunogenicity results were available for at least 1 assay.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2608591|NCT02075541|Secondary|Concentration of Anti Protein D (Anti-PD) Total Immunoglobulin G (IgG) Antibodies Against the NTHi Vaccine Antigens.|Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). The cut-off of the assay was 153 EL.U/mL for anti-PD.|At Day 0, Day 30, Day 60, Day 90, Day 270 and at Day 450.|Analysis was performed on the According to Protocol (ATP) cohort for Immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assigned and for whom post-vaccination immunogenicity results were available for at least 1 assay.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2608592|NCT02075541|Primary|Number of Subjects With Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.|From first vaccination (Day 0) up to study conclusion (Day 450).|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
2608593|NCT02075541|Primary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs).|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From first vaccination (Day 0) up to study conclusion (Day 450).|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
2608594|NCT02075541|Primary|Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.|Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.|At Day 450.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
2608710|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Tmax; The Time to Reach the Maximum Concentration After Drug Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
2608595|NCT02075541|Primary|Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.|Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.|At Day 270.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
2608596|NCT02075541|Primary|Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.|Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.|At Day 90.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
2608597|NCT02075541|Primary|Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.|Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.|At Day 67.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
2608598|NCT02075541|Primary|Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.|Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.|At Day 60.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
2608599|NCT02075541|Primary|Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.|Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.|At Day 30.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
2608600|NCT02075541|Primary|Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.|Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.|At Day 7.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
2608601|NCT02075541|Primary|Number of Subjects With Each Haematological/ Biochemical Laboratory Abnormality.|Assessed haematological parameters are complete blood cell count: Leukocytes [white blood cells (WBC)], differential count (basophils, eosinophils, lymphocytes, monocytes, neutrophils), platelets count, and hemoglobin level below or above the normal laboratory ranges tabulated by time point. Assessed biochemical parameters are alanine aminotransferase (ALT), aspartate aminotransferase (AST) or creatinine below or above the normal laboratory ranges tabulated by time point.|At Day 0.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
2608602|NCT02075541|Primary|Number of Subjects With Any Unsolicited AEs|Assessed unsolicited AEs covered any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 30-day follow-up period (from Day 60 to Day 89) following the second dose.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
2608603|NCT02075541|Primary|Number of Subjects With Any Unsolicited AEs.|Assessed unsolicited AEs covered any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 30-day follow-up period (from Day 0 to Day 29) following the first dose.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
2608688|NCT02075125|Secondary|Pre-procedure Platelet Reactivity Index (PRI)|Platelet reactivity was measured using vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay. Platelet reactivity values were presented as platelet reactivity index (PRI).|Baseline|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as median (Inter-Quartile Range).|||percentage||Inter-Quartile Range|Median
2608605|NCT02075541|Primary|Number of Subjects With Any Solicited General AEs.|Assessed solicited general symptoms are fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (from Day 0 to Day 6) following the first dose.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
2608606|NCT02075541|Primary|Number of Subjects With Any Solicited Local AEs.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (from Day 60 to Day 66) after second dose.|Analysis was performed on the TVC that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
2608607|NCT02075541|Primary|Number of Subjects With Any Solicited Local Adverse Events (AEs).|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During a 7-day follow-up period (from Day 0 to Day 6) after first dose.|Analysis was performed on the Total Vaccinated Cohort (TVC) that included all subjects with at least 1 study vaccine administration documented.|||Participants|||Count of Participants
2608608|NCT02075515|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 to study end (Month 14)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.|||Subjects|||Number
2608609|NCT02075515|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During 30 days (Days 0-29) after each vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.|||Subjects|||Number
2608610|NCT02075515|Secondary|Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology|From first vaccination up to 30 days post last vaccination (Month 0-Month 3) and from Month 4 until study end (Month 14)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.|||Subjects|||Number
2608611|NCT02075515|Secondary|Number of Days With Any Solicited General Symptoms|The number of days with any general symptoms reported during the solicited post-vaccination period.|During the 7 days (Days 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with results available for this assessment.|||Days||Inter-Quartile Range|Median
2608612|NCT02075515|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature= temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0-6) after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered, only on those subjects with the symptom sheets filled in.|||Subjects|||Number
2608613|NCT02075515|Secondary|Number of Days With Any Solicited Local Symptoms|The number of days with any local symptoms reported during the solicited post-vaccination period.|During the 7 days (Days 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with results available for this assessment.|||Days||Inter-Quartile Range|Median
2608614|NCT02075515|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activities.|Within 7 days (Days 0-6) after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered, only on those subjects with the symptoms sheet filled in.|||Subjects|||Number
2608615|NCT02075515|Secondary|Number of Vaccine Responders for Anti-gE Concentrations as Determined by ELISA|"Vaccine response was defined as:~For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration."|At Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.|||Subjects|||Number
2608616|NCT02075515|Secondary|Anti-gE Humoral Immunogenicity|Anti-gE antibody concentrations, were determined by ELISA, expressed as Geometric Mean Concentrations (GMCs), in milli international units per milliliter (mIU/mL).|At Month 0 and Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.|||mIU/mL||95% Confidence Interval|Geometric Mean
2609886|NCT02061202|Secondary|The Medication Adherence Report Scale|The medication adherence report scale for asthma is a 10 question tool scored between 0 and 5, with full scale from 0 to 25, with higher scores indicating greater adherence|20 weeks||||score on a scale||Standard Deviation|Mean
2608617|NCT02075515|Primary|Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value|Anti-gE antibody concentrations, as determined by Enzyme-linked Immunosorbent Assay (ELISA). The cut-off value was ≥ 97 milli international units per milliliter (mIU/mL).|At Month 3|The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all eligible subjects who had post-vaccination immunogenicity results and who complied with the protocol, including the time schedule for vaccination and blood sample draw.|||Subjects|||Number
2608618|NCT02075476|Primary|Effectiveness Will be Measured for DASH (Disabilities of the Arm, Shoulder and Hand) Score|"changes in DASH (Disabilities of the Arm, Shoulder and Hand) score will be measured.~The Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure is a 30-item, self-report questionnaire designed to assess the patient's health status during the previous week. The items enquire about the degree of difficulty in performing different physical activities because of arm, shoulder and hand problems (21 items), the severity of each of the symptoms of pain, activity-related pain, tingling, weakness and stiffness (five items) and the impact of the problem on social functioning, work, sleep and self-image (four items). Each item has five response options. The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability)"|36 months||||score on a scale||95% Confidence Interval|Mean
2608619|NCT02075476|Primary|Effectiveness Will be Measured for Constant Score|"changes in Constant score will be measured.~The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury.~The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function."|36 months||||score on a scale||95% Confidence Interval|Mean
2608620|NCT02075476|Primary|Effectiveness Will be Measured for AMERICAN SHOULDER AND ELBOW (ASES) Score|"changes en ASES (AMERICAN SHOULDER AND ELBOW) score will be measured.~The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. This questionary includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition."|36 months||||score on a scale||95% Confidence Interval|Mean
2608621|NCT02075463|Secondary|Plasma Concentrations of GSK1278863 and Its Metabolites at the Indicated Time Points|Blood samples were collected for individual plasma GSK1278863and metabolite (GSK2391220, GSK2499166, GSK2531403, GSK2531400, GSK2531399, and GSK2531398) concentrations measurement on Day (D) 1 (pre-dose [PrD]), at Week (W) 4 (6-12, 7-13, 8-14, and 9-15 hour [hr] post-dose [PoD), and at W12 (PrD, 1, 2, and 3 hour PoD). Pharmacokinetic population: All participants from whom a PK sample has been obtained and analyzed.|Day 1, Week 4 and Week 12|Pharmacokinetic population|||ng/mL||Standard Deviation|Mean
2608622|NCT02075463|Secondary|Final Dose of GSK1278863|For the first 4 weeks, subjects received 12mg QD of GSK1278863 with dose decrease permitted at Week 2. After 4 weeks of treatment with GSK1278863, need for dose adjustment was evaluated at visits 4, 8 and 12, to maintain hemoglobin within the target range. Target range was defined as: Hgb Criteria of 10.0 to 11.5 g/dL. Data has been presented for only those participants who were available at indicated time points.|Up to 16 Weeks|ITT population|||mg|||Number
2608623|NCT02075463|Secondary|Maximum Observed Change From Baseline in Erythropoietin (EPO)|Blood samples were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose, then 1, 2 and 3 hours after first sample), Week 8 (pre-dose), Week 12 (pre-dose and 3 hour post-dose) and Week 16 (pre-dose) for EPO measurement. The maximum observed change from baseline in EPO was reported. Baseline value for EPO is the last pre-dose value on Day 1. Change from baseline is calculated as the maximum observed value minus the baseline value. Participants who were available at the indicated time point were analyzed.|Baseline (Day 1) to Week 16|ITT population|||international units(IU)/Liter (L)||Standard Deviation|Mean
2608624|NCT02075463|Secondary|Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)|Blood samples were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose, then 1, 2 and 3 hours after first sample), Week 8 (pre-dose), Week 12 (pre-dose and 3 hour post-dose) and Week 16 (pre-dose) for VEGF measurement. The maximum observed percent change from Baseline in VEGF in the subjects was reported. Baseline value for VEGF is the last pre-dose value on Day 1. Percent change was calculated as 100 multiplied by exponential (log observed maximum value minus log Baseline value) minus 1. Participants who were available at the indicated time point were analyzed.|Baseline (Day 1) to Week 16|ITT population|||Percent change||95% Confidence Interval|Geometric Mean
2608625|NCT02075463|Secondary|Change From Baseline in Reticulocyte Number at Week 16|Baseline value for reticulocyte number is the pre-dose value on Day 1. Change from Baseline in reticulocyte number was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points.|Baseline (Day 1) and Week 16|ITT population|||10^12/L|||Number
2608626|NCT02075463|Secondary|Change From Baseline in Red Blood Cell (RBC) at Week 16|Baseline value for RBC (or erythrocytes) is the last pre-dose value on Day 1. Change from Baseline in red blood cells was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points|Baseline (Day 1) and Week 16|ITT population|||10^12/L|||Number
2608627|NCT02075463|Secondary|Change From Baseline in Hematocrit at Week 16|Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Baseline value for hematocrit is the pre-dose value on Day 1. Change from Baseline in hematocrit was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points.|Baseline (Day 1) and Week 16|ITT population|||Fraction of 1|||Number
2608628|NCT02075463|Secondary|Mean Corpuscular Hemoglobin (MCH) at Week 16|Data has been presented for only those participants who were available at indicated time points.|Week 16|Safety population|||pg|||Number
2608629|NCT02075463|Secondary|Mean Corpuscular Volume (MCV) at Week 16|Data has been presented for only those participants who were available at indicated time points.|Week 16|Safety population|||Femtoliter (fL)|||Number
2608631|NCT02075463|Secondary|Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 16|Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline value for total iron binding capacity is the last pre-dose value on Day 1. Change from Baseline in total iron binding capacity was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points.|Baseline (Day 1) and Week 16|ITT population|||µmol/ L|||Number
2608632|NCT02075463|Secondary|Change From Baseline in Total Iron at Week 16|Baseline value for total iron is the last pre-dose value on Day 1. Change from Baseline in total iron was calculated as the Week 16 value minus the Baseline value. Data has been presented for only those participants who were available at indicated time points.|Baseline (Day 1) and Week 16|ITT population|||Micromoles (µmol)/L|||Number
2608633|NCT02075463|Secondary|Percent Change From Baseline in Transferrin Saturation at Week 16|Transferrin saturation is measured in percentage, it is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change is 100 times [exponential (log Week 16 value minus log Baseline value) -1]. Participants who were available at the indicated time point were analyzed.|Baseline (Day 1) and Week 16|ITT population|||Percent change in transferrin||95% Confidence Interval|Geometric Mean
2608634|NCT02075463|Secondary|Change From Baseline in Transferrin at Week 16|Baseline value for transferrin is the last pre-dose value on Day 1. Change from Baseline in transferrin was calculated as the Week 16 value minus the Baseline value. Participants who were available at the indicated time point were analyzed.|Baseline (Day 1) and Week 16|ITT population|||Percent change||Standard Deviation|Mean
2608635|NCT02075463|Secondary|Change From Baseline in Ferritin at Week 16|Baseline value for ferritin is the last pre-dose value on Day 1. Change from Baseline in ferritin was calculated as the Week 16 value minus the Baseline value. Participants who were available at the indicated time point were analyzed.|Baseline (Day 1) and Week 16|ITT population|||Micrograms/Liter||Standard Deviation|Mean
2608636|NCT02075463|Secondary|Percent Change From Baseline in Hepcidin at Week 16|Hepcidin is a regulator of iron metabolism. Baseline value for hepcidin is the pre-dose value on Day 1. Percent change was calculated as 100 multiplied by [exponential (log Week 16 value - log Baseline value) minus 1]. Participants who were available at the indicated time point were analyzed.|Baseline (Day 1) and Week 16|ITT population|||Percent change in hepcidin||95% Confidence Interval|Geometric Mean
2608637|NCT02075463|Secondary|Number of Participants Reaching Pre-defined Hgb Stopping Criteria|The number of participants who reached the Hgb stopping criteria of Hgb concentration <7.5 g/dL from baseline to Week 16 were presented. Participants who were available at the indicated time point were analyzed.|Up to Week 16|ITT population|||Participants|||Number
2608638|NCT02075463|Secondary|Number of Participants With Hgb in the Target Range at Week 16|The number of participants with Hgb in the target range of 10.0 to 11.5 g/dL at Week 16 were analyzed. Participants who were available at the indicated time point were analyzed.|Week 16|ITT population|||Participants|||Number
2608639|NCT02075463|Secondary|Number of Participants Achieving at Least 1 g/dL Increase in Hgb From Baseline at Week 16|Number of participants achieving at least 1 g/dL increase in Hgb from baseline at Week 16 were presented. Participants who were available at the indicated time point were analyzed.|Baseline and Week 16|ITT population.|||Participants|||Number
2608640|NCT02075463|Secondary|Percentage of Time (Days) Hgb Levels Within, Below and Above Target Range at the Indicated Time Point|The percentage of time in Hgb levels were in target range (10.0 to 11.5 g/dL) between Weeks 12 and 16 for a participant was calculated by adding the total number of days that Hgb is within target range while on treatment during Weeks 12 to 16 and dividing by the total number of days the participant remained on treatment during Weeks 12 to 16 (using Rosendaal linear interpolation method). Similarly, percentage of time above Hgb target range and percentage of time below Hgb target range were calculated. Participants who were available at the indicated time point were analyzed.|Week 12 to Week 16|ITT population.|||Percentage of days||Standard Deviation|Mean
2608641|NCT02075463|Secondary|Change From Baseline in Hgb Levels at Week 16|Hgb values measured at Week 16 are presented. Change from baseline was calculated as Week 16 minus baseline value . Participants who were available at the indicated time point were analyzed.|Week 16|ITT population.|||g/dL||Standard Deviation|Mean
2608642|NCT02075463|Primary|Percentage of Participants Demonstrating an Increase in Hgb of >=1 g/dL (if Baseline Hgb is <9.5 g/dL), or >=0.5 g/dL (if Baseline Hgb is 9.5-<10 g/dL), or Stay Within Target Range and do Not Drop by >0.5 g/dL (if Baseline Hgb is >= 10 g/dL) at Week 16|Percentage of participants with increased Hgb >=1 g/dL (if baseline Hgb is <9.5 g/dL), or >=0.5 g/dL (if baseline Hgb is 9.5-<10 g/dL), or within the target range and not dropped by >0.5 g/dL (if baseline Hgb is >= 10 g/dL) at Week 16 are presented. Participants who were available at the indicated time point were analyzed|Week 16|ITT population: participants who received at least one dose of drug, have a baseline Hgb and at least one corresponding on treatment Hgb assessment.|||Percentage of participants||95% Confidence Interval|Number
2608643|NCT02075411|Other Pre-specified|Failure of Nerve Block Procedures|We will determine the proportion of failure of the nerve block procedures as assessed by absence of a sensory block in the distribution of the femoral or sciatic nerves. The analysis will be of the numerical rating scale (NRS) scores immediately on arrival (baseline) in the recovery room and then every 6 hours over the first 72 hours post-op in the 2 groups.|72 hours post-operatively|Sample size was too small to conduct outcome analysis||||||
2608644|NCT02075411|Secondary|Duration of Analgesia in the Single Injection Nerve Block and the Continuous Peripheral Neural Infusion Group|Determine the duration of analgesia in the 2 groups. Analgesic duration will be the time interval between the end of the operation and the time of first administration of opioid for pain relief|72 hours post-operatively|Sample size was too small to conduct outcome analysis||||||
2608645|NCT02075411|Primary|Opioid Pain Medication|total postoperative opioid pain medication used during the first 72 hours after the procedure|72 hours post-operatively|Sample size was too small to conduct outcome analysis||||||
2608646|NCT02075320|Secondary|Reader Preference|To evaluate radiologists confidence in evaluating lung nodules of all sizes comparing s-DCT to CT. Readers will be scored using a 7 point Likert scale from -3 to +3. Negative scores in favor of CT and positive scores more in favor of s-DCT. Readers rated images based on shape/morphology, calcifications, and architectural distortion|1 year following imaging||||units on a scale||Standard Deviation|Mean
2608647|NCT02075320|Secondary|Specificity of s-DCT (Percentage) for Malignant Lesions.|"Specificity for this objective is defined as the ability of the s-DCT system to identify a lesion as non-malignant over the course of 1 year post s-DCT. The gold standard will vary depending on the clinical situation as follows:~In the subset of who undergo a biopsy of a suspicious lesion, the pathology report will be the gold standard.~If a biopsy is not performed, but CT scan is performed within the 1 year timeframe, and a diagnosis of malignancy based on this nodule is made, the CT scan will be the gold standard.~If a biopsy or CT scan is not performed, but the clinical records indicate the lesion is malignant (within the one year timeframe), this will be the gold standard."|1 year following imaging|Insufficient numbers of patients had follow-up biopsies, imaging, or follow-up. Ratio could not be calculated as the denominator is 0.||||||
2608648|NCT02075320|Primary|Specificity|Specificity for our study is defined as the ability of s-DCT to correctly identify the absence of a lung nodule as confirmed by CT (gold standard).|1 year following imaging|All subjects|||percentage of negative scans|||Number
2608649|NCT02075320|Primary|Sensitivity|Sensitivity for our study is defined as the ability of s-DCT to detect a lung lesion known to exist based on non-contrast CT (the gold standard) for any sized lung nodule.|1 year following imaging||||percentage of positive scans|||Number
2608650|NCT02075255|Secondary|Inspiratory Capacity|Change from baseline in inspiratory capacity|From baseline to Week 28|Global Sputum Substudy|||Liter||Standard Deviation|Mean
2608651|NCT02075255|Secondary|Functional Residual Capacity|Change from baseline in functional residual capacity|From baseline to Week 28|Global Sputum Substudy|||Liter||Standard Deviation|Mean
2608652|NCT02075255|Secondary|Vital Capacity|Change from baseline in vital capacity|From baseline to Week 28|Global Sputum Substudy|||Liter||Standard Deviation|Mean
2608653|NCT02075255|Secondary|Residual Volume|Change from baseline in residual volume|From baseline to Week 28|Global Sputum Substudy|||Liter||Standard Deviation|Mean
2608654|NCT02075255|Secondary|Total Lung Capacity|Change from baseline in total lung capacity|From baseline to Week 28|Global Sputum Substudy|||Liter||Standard Deviation|Mean
2608655|NCT02075255|Secondary|Percent Change From Baseline in Blood Eosinophil Counts|Percent change from baseline in blood eosinophil counts at week 28|Change from baseline at Week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||percent change||Standard Deviation|Mean
2608656|NCT02075255|Secondary|Anti-drug Antibody Response|Number and percentage of patients in different ADA response categories|From baseline to follow-up Week 36|Safety analysis set|||Participants|||Count of Participants
2608657|NCT02075255|Secondary|Serum Concentration of Benralizumab|Pre-dose serum concentrations at each visit|Pre-first dose to Week 36|PK analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2608658|NCT02075255|Secondary|Extent of Exposure|Duration of exposure from first dose date to last dose date.|From first dose to Week 24|Safety analysis set|||Days||Standard Deviation|Mean
2608659|NCT02075255|Secondary|AQLQ(s)+12 Responders (Improvement) at Week 28|AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. Improvement is defined as AQLQ(S)+12 (End of treatment - baseline)>=0.5. No change is defined as AQLQ(S)+12 (End of treatment - baseline) >-0.5 and <0.5. Deterioration is defined as AQLQ(S)+12 (End of treatment - baseline) <= -0.5. Baseline is defined as the last AQLQ(S)+12 score prior to randomisation. End of treatment is defined as week 28. Patients with missing or non-evaluable score at week 28 are considered as non-responder.|Week 28|Full analysis set|||Participants|||Number
2608660|NCT02075255|Secondary|Change From Baseline at Week 28 in AQLQ(S)+12 (Overall)|AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||Scores on a scale||Standard Deviation|Mean
2608661|NCT02075255|Secondary|ACQ-6 Responders (Improvement) at Week 28|Improvement is defined as ACQ-6 (End of treatment - baseline) <= -0.5. No change is defined as ACQ-6 (End of treatment - baseline) >-0.5 and <0.5. Deterioration is defined as ACQ-6 (End of treatment - baseline) >= 0.5. ACQ-6 score is defined as the average of the first 6 items of the ACQ questionnaire on symptoms, activity limitations and rescue medication.Scores range from 0 (totally controlled) to 6 (severely uncontrolled). Baseline is defined as the last non-missing value prior to randomisation. End of treatment is defined as week 28. Patients with missing or non-evaluable ACQ-6 at week 28 are considered non-responder.|Week 28|Full analysis set|||Participants|||Number
2608662|NCT02075255|Secondary|Change From Baseline to Week 28 in ACQ-6|ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||Scores on a scale||Standard Deviation|Mean
2608663|NCT02075255|Secondary|Change From Baseline to Week 28 in the Proportion of Nights With Awakening Due to Asthma Requiring Rescue Medication|Baseline is defined as the proportion of nights from the evening of study day -14 to the morning of study day 1.Each timepoint is calculated as bi-weekly proportions based on daily diary data. If more than 50% of data are missing in a 14 day period then this will be considered as missing.Proportion of nights with noctural awakenings is defined as the number of nights with awakenings due to asthma and requiring rescue medication divided by number of nights with data.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||Proportion||Standard Deviation|Mean
2608664|NCT02075255|Secondary|Change From Baseline to Week 28 in Home Lung Function (Evening Peak Expiratory Flow)|Evening peak expiratory flow change from baseline to week 28. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||Liter/min||Standard Deviation|Mean
2608665|NCT02075255|Secondary|Change From Baseline to Week 28 in Home Lung Function (Morning Peak Expiratory Flow)|Morning peak expiratory flow change from baseline to week 28. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||Liter/min||Standard Deviation|Mean
2608666|NCT02075255|Secondary|Change From Baseline to Week 28 in Rescue Medication Use|Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this will be considered as missing. The number of inhalations (puffs) per day will be calculated as follows: Number of night inhaler puffs + 2 x [number of night nebulizer times] + number of day inhaler puffs + 2 x [number of day nebulizer times].|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||number of puffs per day||Standard Deviation|Mean
2608667|NCT02075255|Secondary|Change From Baseline to Week 28 in Asthma Symptom Scores (Nighttime)|Asthma symptoms during night time are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma). Lower score (0) is indicating better asthma symptom, while higher score (3) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||Scores on a scale||Standard Deviation|Mean
2608668|NCT02075255|Secondary|Change From Baseline to Week 28 in Asthma Symptom Scores (Daytime)|Asthma symptoms during daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma). Lower score (0) is indicating better asthma symptom, while higher score (3) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||Scores on a scale||Standard Deviation|Mean
2608669|NCT02075255|Secondary|Change From Baseline to Week 28 in Asthma Symptom Scores (Total)|Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -14 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||Scores on a scale||Standard Deviation|Mean
2608670|NCT02075255|Secondary|Change From Baseline to Week 28 in Pre-bronchodilator FEV1|Baseline is defined as the last non-missing value prior to the first dose of study treatment. Change from baseline to Week 28 in two treatment groups is compared to placebo group.|Change from baseline at week 28|Full analysis set. Number of participants analyzed contains number of participants who had value at Week 28.|||Liter||Standard Deviation|Mean
2608671|NCT02075255|Secondary|Number of Days in Hospital Due to Asthma|Number of days in hospital due to asthma, if none, 0 day is considered|The time from randomisation to the date of week 28 visit (end of treatment) or last contact if the patient is lost to follow up|Full analysis set|||Days||Standard Deviation|Mean
2608672|NCT02075255|Secondary|The Annualized Rate of Asthma Exacerbations That Are Associated With an Emergency Room Visit or a Hospitalization|The annualized exacerbation rate is based on unadjudicated exacerbation reported by the investigator that are associated with an emergency room visit or a hospitalization adjusted by the time of follow-up.|The time from randomisation to the date of week 28 visit (end of treatment) or last contact if the patient is lost to follow up|Full analysis set|||events/year||95% Confidence Interval|Least Squares Mean
2608673|NCT02075255|Secondary|The Annualized Rate of Asthma Exacerbation|The annualized exacerbation rate is based on unadjudicated exacerbation reported by the investigator adjusted by the time of follow-up.|The time from randomisation to the date of week 28 visit (end of treatment) or last contact if the patient is lost to follow up|Full analysis set|||events/year||95% Confidence Interval|Least Squares Mean
2608674|NCT02075255|Secondary|Time to the First Asthma Exacerbation Requiring Hospitalization or ER Visit|Time to the first exacerbation requiring hospitalization or ER visit post randomisation|The time from randomisation to the date of first asthma exacerbation associated with hospitalization or ER over 28 weeks.|Full analysis set|||Days||95% Confidence Interval|Median
2608675|NCT02075255|Secondary|Time to the First Asthma Exacerbation|Time to the first occurrence of asthma exacerbation post randomisation|The time from randomisation to the date of first asthma exacerbation over 28 weeks|Full analysis set|||Days||95% Confidence Interval|Median
2608676|NCT02075255|Secondary|Number and Percentage of Patients With ≥1 Asthma Exacerbation|Number and percentage of patients with at least one post randomisation asthma exacerbation.|Immediately following the randomisation through Study Week 28|Full analysis set|||Participants|||Count of Participants
2608677|NCT02075255|Secondary|The Proportion of Patients With Average Final OCS Dose ≤5.0 mg Daily at Visit 14, While Maintaining Asthma Control|Final OCS dose is the dose at Week 28. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.|Week 28|Full analysis set|||Participants|||Number
2608678|NCT02075255|Secondary|The Proportion of Patients With ≤5.0 mg Reduction on Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma Control.|Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.|Week 28|Full analysis set|||Participants|||Number
2608679|NCT02075255|Secondary|The Proportion of Eligible Patients With ≥100% Reduction in Average Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma Control|Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose-final dose)/baseline dose}*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.|Week 28|Full analysis set, eligible for 100% reduction (ie, patients with baseline OCS dose <= 12.5 mg)|||Participants|||Number
2608680|NCT02075255|Secondary|The Percentage of Patients With ≥50% Reduction in Average Daily OCS Dose at Visit 14 Compared With Baseline Dose at Visit 6, While Maintaining Asthma Control|Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose-final dose)/baseline dose}*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.|Week 28|Full analysis set|||Participants|||Count of Participants
2608681|NCT02075255|Secondary|Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control for Patients With Baseline Eosinophils >=300/uL|Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose-final dose)/baseline dose}*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.|Week 28|Full analysis set, baseline blood eosinophil >=300/uL|||Percent||95% Confidence Interval|Median
2608682|NCT02075255|Secondary|Number and Percentage of Patients in Different Categories of Percent Reduction From Baseline in Final OCS Dose While Maintaining Asthma Control|Number and percentage of patients in different categories of percent reduction from baseline in final OCS dose.|Week 28|Full analysis set|||Participants|||Count of Participants
2608683|NCT02075255|Primary|Percentage Reduction in Final OCS Dose Compared With Baseline While Maintaining Asthma Control|Baseline OCS dose is the dose upon which the patient is stabilised at randomisation (Week 0). Final OCS dose is the dose at Week 28. The percentage reduction from baseline is defined as: {(Baseline dose-final dose)/baseline dose}*100%. If a patient discontinues from the study during a given dose reduction period, or the patient experiences an exacerbation between Weeks 24 and 28 or immediately before discontinuation, then the final OCS dose will be 1 dose level higher than that which directly preceded the event.|Week 28|Full analysis set|||Percent||95% Confidence Interval|Median
2608684|NCT02075203|Secondary|Percentage of Participants With Immune Response to Vaccine in HIV-uninfected, Remotely BCG-vaccinated Adolescents: o H4:IC31 o BCG Revaccination|"A 13 color intracellular cytokine staining assay (ICS) was performed on peripheral blood mononuclear cells (PBMC) to assess CD4+ T cells that expressed IFN-γ, TNF, IL-2, IL-17, IL-22, CD107a, and/or CD154 alone or in combination in response to stimulation with peptide pools representing the entire amino acid sequence of the TB mycobacterial antigens Ag85B and TB10.4, and BCG antigens. Responders were IFN-gamma and/or IL-2 positive.~An intracellular cytokine assay was performed on whole blood (WB) to measure the frequencies and patterns of CD4+ T cells expressing Th1 and Th17 cytokines following stimulation of whole blood with peptide pools representing the entire amino acid sequence of the TB mycobacterial antigens Ag85B and TB10.4, as well as viable BCG from the vaccine vial. Responders were IFN-gamma, IL-2, TNF, IL-17, and/or IL-22 positive."|Study day 70|Modified ITT analysis set: Safety and immunogenicity cohort|||percentage of participants|||Number
2608685|NCT02075203|Secondary|Rates of Sustained Conversion to Mtb-positive|"Rates of sustained conversion to Mtb-positive as measured by QFT-GIT assay.~H4:IC31 compared to placebo~BCG revaccination compared to placebo"|6 months after initial conversion|Modified Intent-to-Treat|||participants|||Number
2608686|NCT02075203|Primary|Number of Participants Testing Positive for Mtb at Day 84|"Rates of conversion to Mtb-positive measured by QuantiFERON-TB Gold In-tube (QFT-GIT) assay. The primary evaluation of Mtb infection was QFT-GIT conversion from a negative to positive test, using the manufacturer's recommended threshold of ≥0.35 IU/mL, at any time point after Day 84 and through end of follow-up for the primary endpoint. All participants with primary QFT-GIT conversion were followed for an additional 6 months post-conversion to ascertain the sustained QFT-GIT conversion and QFT-GIT reversion endpoints. Participants with an initial QFT-GIT conversion at Month 6 or 12 were asked to return for a final QFT-GIT evaluation and assessment for TB signs and symptoms at least 24 months after their initial vaccination.~H4:IC31 compared to placebo~BCG revaccination compared to placebo"|Study day 84 through 6 months post-conversion|Intent-to-Treat|||participants|||Number
2608687|NCT02075203|Primary|Safety Profile of H4:IC31 and BCG Revaccination in HIV-uninfected, Remotely BCG Vaccinated Adolescents.|"Number of unsolicited and solicited adverse events recorded post vaccination.~Unsolicited adverse events: 28 days post each vaccination~Solicited adverse events: 7 days post each vaccination (with diary cards used for 7 days after each vaccination for Safety and Immunogenicity Cohort only)~Solicited and unsolicited injection site reaction adverse events: BCG Group - 84 days post vaccination; H4:IC31/Placebo Groups - 28 days post each vaccination~Serious adverse events, adverse events of special interest, and SUSARs: Entire study period, with a minimum of 6 months following the last dose of study vaccine"|Study day 7 thru 6 months after last vaccination||||number of AEs|||Number
2608708|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: AUCinf; The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to Infinity||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
2608689|NCT02075125|Secondary|Number of Participants With Low Platelet Reactivity|Platelet reactivity were measured using VerifyNow (volumetrics accuretic, San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. Low platelet reactivity (LPR) is defined as the result of P2Y12 reaction units (PRU) <85 and platelet reactivity index (PRI)<16%. The PRU value for LPR, 18 patients were in prasugrel groups and 19 patients in ticagrelor groups, regarding the PRI value for LPR, 16 patients were in each groups.|48 hours after loading dose of study drug|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher’s exact test, as appropriate.|||participants|||Number
2608690|NCT02075125|Secondary|Pre-procedure P2Y12 Reaction Units (PRU)|Platelet reactivity was measured using VerifyNow (volumetrics accuretic, San Diego, California, USA). Platelet reactivity values were presented as P2Y12 reaction units (PRU).|Baseline|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as median (Inter-Quartile Range).|||PRU units||Inter-Quartile Range|Median
2608691|NCT02075125|Secondary|Adverse Drug Reaction|Any adverse reaction related to study drug until 30 days after percutaneous coronary intervention.|30 days|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number, compared with chi-square statistics or Fisher’s exact test, as appropriate.|||participants|||Number
2608692|NCT02075125|Secondary|Bleeding Event|Any event related to bleeding including access site bleeding and peri-procedural bleeding based on Bleeding Academic Research Consortium (BARC) criteria.|30 days|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher’s exact test, as appropriate.|||participants|||Number
2608693|NCT02075125|Secondary|Major Adverse Cardiac and Cerebrovascular Events|Any major adverse cardiac and cerebrovascular event including (death, myocardial infarction, or revascularization and stroke) until day 30.|30 days|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher’s exact test, as appropriate.|||participants|||Number
2608694|NCT02075125|Primary|Number of Participants With High Platelet Reactivity|Platelet reactivity were measured by VerifyNow (volumetrics accuretic，San Diego, California, USA), and vasodilator-stimulated phosphoprotein (VASP) phosphorylation P2Y12 assay (BioCytex, Marseille, France) with FACSCalibur flow cytometer (BD Biosciences, San Jose, California, USA) using. Measurement time gap +/- 12 hours were allowed. High platelet reactivity (HPR) is defined as the result of P2Y12 reaction units (PRU) >235 and platelet reactivity index (PRI) >50%.|48 hours after loading dose of study drug|Analysis population was performed on an intention to treat basis, descriptive analysis was performed by presenting the data as number (proportion), compared with chi-square statistics or Fisher’s exact test, as appropriate.|||participants|||Number
2608695|NCT02075073|Secondary|Time to Cmax (Tmax)||57 days||||hour||Standard Deviation|Mean
2608696|NCT02075073|Primary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)||57 days||||µg·h/mL||Standard Deviation|Mean
2608697|NCT02075073|Primary|Maximum Serum Concentration (Cmax)||57 days||||µg/mL||Standard Deviation|Mean
2608698|NCT02075073|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)||57 days||||µg·h/mL||Standard Deviation|Mean
2608699|NCT02075021|Secondary|the Number of Patients Who Achieve Complete Response (CR) or Partial Response (PR) (Phase II)|The response will be determined using the International Uniform Response Criteria for Multiple Myeloma.|up to 2 years|Results were not analyzed due to lack of sufficient data. PI left the institution.||||||
2608700|NCT02075021|Primary|Maximum Tolerated Dose (Phase I)|Dose limiting toxicity will be accessed based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|4 weeks|Results were not analyzed due to lack of sufficient data. PI left the institution.||||||
2608701|NCT02075008|Primary|Numbers of Participants With Non-serious Adverse Events (AEs), Serious AEs and Deaths as a Measure of Safety and Tolerability|Safety was monitored throughout the study.|52 weeks|The safety set, which included all participants, was analyzed.|||Participants|||Count of Participants
2608702|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: CL/F; The Apparent Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Extravascular Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
2608703|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Vz/F; The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
2608704|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Vss; The Volume of Distribution at Steady State Following Intravenous Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
2608705|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: Vz; The Volume of Distribution During the Terminal Elimination Phase Following Intravenous Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
2608706|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: CL; The Systemic (or Total Body) Clearance From Plasma (or Serum or Blood) Following Intravenous Administration||Groups 1: Day 1through to Day 56: Groups 2,3&4:Day 1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
2608707|NCT02074995|Secondary|Serum Pharmacokinetics (PK) of BVS857: T1/2; The Terminal Elimination Half-life||Groups 1: Day 1through to Day 56: Groups 2,3&4:ay D1 through to Day 105|Terminated study underpowered due to low enrollment (n=1 patient). No analysis can be provided||||||
2610333|NCT02057549|Secondary|Pain Score as Measured by a Visual Analogue Scale (VAS)|The Visual Analogue Scale (VAS) ranges from 0-10, with 0 being the absence of pain and 10 the worst imaginable pain.|before study medication given||||units on a scale||Standard Deviation|Mean
2608714|NCT02074982|Secondary|Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 52|"Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).~PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 52"|Week 52|Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures.|||percentage of participants|||Number
2608715|NCT02074982|Secondary|Speed of Onset Based on the Percentage of Participents Achieving PASI 75 at Week 4|"Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).~Speed of Onset was based on percentage PASI 75 responders and were defined as participants achieving ≥ 75% improvement at Week 4"|Week 4|Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures.|||percentage of participants|||Number
2608716|NCT02074982|Primary|Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16|"Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).~PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 16"|Week 16|Full Analysis Set (FAS) included all randomized patient minus 1 patient that was excluded due to missing informed consent prior to initiating study procedures.|||Percentage of Participants|||Number
2608717|NCT02074904|Secondary|Mean Alcohol Consumption|change in mean alcohol consumption from baseline to 9 weeks|baseline to 9 weeks|The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.||||||
2608718|NCT02074904|Secondary|Heavy Drinking Days|change in number of heavy drinking days from baseline to 9 weeks|baseline to 9 weeks|The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.||||||
2608719|NCT02074904|Secondary|Change in Gamma-glutamyl Transferase (GGT) or Carbohydrate-deficient Transferrin (CDT) Levels|Change in gamma-glutamyl transferase (GGT) or carbohydrate-deficient transferrin (CDT) levels after 9 weeks of treatment.|baseline and Visit 9 (9 weeks)|The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.||||||
2608720|NCT02074904|Secondary|Drinking Days|change in drinking days from baseline to 9 weeks|baseline and 9 weeks|The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.||||||
2608721|NCT02074904|Primary|fMRI Response in the Ventral Striatum/Medial Orbitofrontal Cortex During Alcohol Cue Exposure|At baseline (prior to randomization), brain and behavioral responses will be significantly greater during alcohol cue exposure compared to non-alcohol cue exposure. Following 6 weeks of study drug, individuals receiving topiramate will demonstrate greater reductions in brain activity and drinking behavior compared to individuals receiving placebo. Individuals receiving placebo will exhibit responses similar to baseline responses.|baseline to after 6 weeks of study drug|The study was terminated to run as a sub-study of NCT02371889. No data will be entered due to privacy concerns.||||||
2608722|NCT02074735|Primary|Heavy Drinking Days Per Week|"Heavy drinking days are defined as 4 or more drinks for women, 5 or more drinks for men in a single day. Participants self-reported the type and amount of alcohol consumed during each assessment period. From this information, number of standard drinks per day was calculated using the following formula: (number of drinks) x (oz per drink) x (alcohol by volume or ABV). The average number of heavy drinking days was calculated by dividing the number of heavy drinking days per week by the number of days in the assessment period."|12 weeks||||days/week||Standard Deviation|Mean
2608723|NCT02074709|Primary|Postoperative Pain Score on Coughing at 6 hr|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed at 6 hr after surgery||||units on a scale||Standard Deviation|Mean
2608724|NCT02074553|Secondary|Time to Reach Last Quantifiable Plasma Concentration (Tlast) of Alectinib and RO5468924|Tlast is the time from alectinib administration to reach last quantifiable concentration of alectinib and its major pharmacologically active metabolite RO5468924.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||hours||Full Range|Median
2608725|NCT02074553|Secondary|Molecular Weight Adjusted M/P Ratio for Cmax|Cmax is the maximum observed plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib). The molecular weight adjusted M/P ratio (RO5468924/alectinib) for Cmax is presented.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||ratio||Standard Deviation|Geometric Mean
2608726|NCT02074553|Secondary|Molecular Weight Adjusted M/P Ratio for AUC(0-last)|AUC(0-last) is the area under the plasma concentration versus time curve from time zero to the time of last measured concentration. AUC is a measure of the plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) over time. The molecular weight adjusted M/P ratio (RO5468924/alectinib) for AUC(0-last) is presented.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||ratio||Standard Deviation|Geometric Mean
2608727|NCT02074553|Secondary|Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for AUC(0-inf)|AUC(0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) over time. The molecular weight adjusted M/P ratio (RO5468924/alectinib) for AUC(0-inf) is presented.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||ratio||Standard Deviation|Geometric Mean
2608728|NCT02074553|Secondary|Adjusted r^2 Value (Rsq) for Regression Estimation of Kel for Alectinib and RO5468924||Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||no units||Standard Deviation|Mean
2608729|NCT02074553|Secondary|Percent Extrapolated AUC(0-inf) (AUC%Extrap[0-inf]) for Alectinib and RO5468924|The AUC%extrap(0-inf), that is, area obtained after extrapolation from Tlast to infinity is calculated by using the formula AUC%extrap(0-inf) = 100*(AUC[0-inf] minus AUC[0-last])/AUC(0-inf); where AUC(0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time and AUC(0-last) is area under the plasma concentration time-curve from zero (pre-dose) to the time of last measured concentration. The function of this parameter is to provide information about what percentage of the theoretical curve AUC(0-inf) was possible to determine experimentally (AUC0-last).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||percent AUC||Standard Deviation|Mean
2608730|NCT02074553|Secondary|Apparent Volume of Distribution (Vz/F) of Alectinib|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction of drug absorbed.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||liters||Standard Deviation|Mean
2608731|NCT02074553|Secondary|Apparent Oral Clearance (CL/F) of Alectinib|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||liters/hour||Standard Deviation|Mean
2608732|NCT02074553|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by AUC(0-last)|AUC(0-last) is the area under the alectinib + RO5468924 (major pharmacologically active metabolite of alectinib) molar plasma concentration versus time curve from time zero to the time of last measured concentration of alectinib + RO5468924. AUC(0-last) is presented in nmol*hour/L.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||nmol*hour/L||Standard Deviation|Mean
2608733|NCT02074553|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by Cmax|Cmax is the maximum observed molar plasma concentration for alectinib + RO5468924 (major pharmacologically active metabolite of alectinib). Cmax is presented in nanomoles per liter (nmol/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||nmol/L||Standard Deviation|Mean
2608734|NCT02074553|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by AUC(0-inf)|AUC(0-inf) is the area under the alectinib + RO5468924 (major pharmacologically active metabolite of alectinib) molar plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the alectinib + RO5468924 over time. AUC(0-inf) is presented in nanomoles times (*) hour per liter (nmol*hour/L).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||nmol*hour/L||Standard Deviation|Mean
2608735|NCT02074553|Secondary|Elimination Rate Constant (Kel) of Alectinib and RO5468924|First-order terminal elimination rate constant (Kel) was calculated as the negative slope of the linear regression of the terminal phase in plasma alectinib and RO5468924 concentration versus time profile using appropriate time points. RO5468924 is the major pharmacologically active metabolite of alectinib.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||1/hour||Standard Deviation|Mean
2608736|NCT02074553|Secondary|Plasma Terminal Half-Life (t1/2) of Alectinib and RO5468924|Plasma terminal half-life is the time measured during drug elimination phase for the plasma drug concentration to decrease by one half. RO5468924 is the major pharmacologically active metabolite of alectinib.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||hours||Standard Deviation|Mean
2608737|NCT02074553|Secondary|AUC(0-last) of RO5468924|AUC(0-last) is the area under the RO5468924 plasma concentration versus time curve from time zero to the time of last measured concentration of RO5468924. RO5468924 is the major pharmacologically active metabolite of alectinib. AUC is a measure of the plasma concentration of a drug over time. AUC(0-last) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||ng*hour/mL||Standard Deviation|Mean
2608738|NCT02074553|Secondary|AUC(0-inf) of RO5468924|AUC(0-inf) is the area under the RO5468924 plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). RO5468924 is the major pharmacologically active metabolite of alectinib. AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||ng*hour/mL||Standard Deviation|Mean
2608739|NCT02074553|Secondary|Tmax of RO5468924|Tmax is the time from alectinib administration to reach Cmax for RO5468924 (the major pharmacologically active metabolite of alectinib).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||hours||Full Range|Median
2608740|NCT02074553|Secondary|Cmax of RO5468924|Cmax is the maximum observed plasma RO5468924 concentration, presented in ng/mL. RO5468924 is the major pharmacologically active metabolite of alectinib.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||ng/mL||Standard Deviation|Mean
2608743|NCT02074553|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of Alectinib|AUC(0-last) is the area under the alectinib plasma concentration versus time curve from time zero to the time of last measured concentration of alectinib. AUC is a measure of the plasma concentration of a drug over time. AUC(0-last) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|PK analysis set|||ng*hour/mL||Standard Deviation|Mean
2608744|NCT02074553|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC[0-inf]) of Alectinib|AUC(0-inf) is the area under the alectinib plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in nanogram times (*) hour per milliliter (ng*hour/mL).|Predose (0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 60, 72, and 96 hours postdose|The Pharmacokinetic (PK) analysis set included all participants who received the reference formulation 50% SLS alectinib (Treatment A) and at least 1 test formulation (Treatments B, C, or D) and provided adequate PK assessments.|||ng*hour/mL||Standard Deviation|Mean
2608745|NCT02074514|Secondary|Percentage of Participants With Virologic Failure and Viral Relapse|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2608746|NCT02074514|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2608747|NCT02074514|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set|||percentage of participants|||Number
2608748|NCT02074514|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set (FAS): participants with genotype 1 or 3 HCV infection who were randomized into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2608749|NCT02074384|Primary|Portion of Study Participants Reporting Greater Utility From AGP vs. Traditional Glucose Data Reports|Patients will use either SMBG or CGM for a two week period following their screening visit. At the end of the two week period they will return to the study site to download their device and have an AGP report printed. They will then complete a preference and utility survey.|At the end of the two week SMBG or CGM period||||participants|||Number
2608750|NCT02074358|Secondary|Mean Change From Baseline Temperature on Day 4 and Day 7|Temperature was recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period and was measured in degrees centigrade (C). Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose.|Screening, Day -1 first treatment period, Days 4 and 7 post treatment|Those participants who received any study medication and had temperature data at baseline and post baseline were analyzed.|||C||Standard Deviation|Mean
2608751|NCT02074358|Secondary|Mean Change From Baseline in Respiration Rate on Day 4 and Day 7|Respiration Rate was recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period. Respiration Rate was measured after the participant had been seated quietly for at least 5 minutes and was measured in respirations (breaths) per minute. Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose.|Screening, Day -1 first treatment period, Days 4 and 7 post treatment|Those participants who received any study medication and had respiration rate data at baseline and post baseline were analyzed.|||breaths per minute||Standard Deviation|Mean
2608752|NCT02074358|Secondary|Mean Change From Baseline in Heart Rate on Day 4 and Day 7|Heart Rate was recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period. Heart Rate was measured after the participant had been seated quietly for at least 5 minutes and was measured in beats per minute (bpm). Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose.|Screening, Day -1 first treatment period, Days 4 and 7 post treatment|Those participants who received any study medication and had heart rate data at baseline and post baseline were analyzed.|||bpm||Standard Deviation|Mean
2608753|NCT02074358|Secondary|Mean Change From Baseline in Diastolic and Systolic Blood Pressure on Day 4 and Day 7|Blood pressures were recorded at screening, Day -1 of Period 1, and Days 4 and 7 of each period. Blood pressure was measured after the participant had been seated quietly for at least 5 minutes and was measured in millimeters of mercury (mmHg). Baseline was last non-missing result with a collection date-time less than the date-time of the first active dose.|Screening, Day -1 first treatment period, Days 4 and 7 post treatment|Those participants who received any study medication and had blood pressure data at baseline and post baseline were analyzed.|||mmHg||Standard Deviation|Mean
2608754|NCT02074358|Secondary|Number of Participants With Out of Range Electrocardiogram (ECG) Intervals and Number of Participants With a Change From Baseline of Greater Than 30 Milliseconds in QT and QTcF|Single 12-lead ECGs were obtained at screening, Day -1 of Period 1, and Days 4 and 7 of each treatment period after the participant had been supine for at least 5 minutes. Pulse Rate (PR), Complex of Q, R, S waves (QRS), and contraction of ventricle between the beginning of the Q wave and end of the T wave (QT) were measured in milliseconds (msec). QT was corrected by the Fridericia method (QTcF) and measured in msec. Baseline was Day -1 of first treatment period. Crossover study: same participant with out of range ECG intervals could be reported in multiple arms.|Day -1 first treatment period, Days 4 and 7 each treatment period|Those participants who received any study medication and had available ECG data at baseline and Days 4 and 7 in each treatment period were analyzed.|||participants|||Number
2608997|NCT02071290|Primary|Neutrophil Adhesion Molecule Expression (CD62L)|Change in neutrophil adhesion molecule (CD62L) expression over 24 hours from admission. Measured by flow cytometry using whole blood samples.|0 (Admission), 1, 3, 24 hours after intervention||||Median Fluorescence Intensity||Inter-Quartile Range|Median
2608755|NCT02074358|Secondary|Number of Participants With Marked Abnormalities (MA) in Laboratory Tests - Treated Population|Blood, urine samples obtained at screening, Days -1, 4, and 7 of each treatment period, and study discharge (Day 11 of Treatment Period 3). MA: Leukocyte White Blood Cells (WBC) *10^3 cells per microliter (c/µL); High (H): > 1.2*upper limits normal (ULN) if lower limits normal (LLN) <= pre-therapy (PreRx) <= ULN; > 1.2*ULN if PreRx = Missing; > 1.5*PreRx if PreRx > ULN; > ULN if PreRx < LLN. Alanine Aminotransferase (ALT) units per liter (U/L); H: > 1.25*PreRx if PreRx > ULN; > 1.25*ULN if PreRx <= ULN; > 1.25*ULN if PreRx = Missing. Total and Direct Bilirubin in milligrams/deciliter (mg/dL) H: > 1.1*ULN if PreRx <= ULN;> 1.1*ULN if PreRx = Missing; > 1.25*PreRx if PreRx > ULN. Blood in Urine H: >= 2*PreRx if PreRx >= 1; >= 2 if PreRx < 1; >= 2 if PreRx = Missing. Urine Red Blood Cells (RBC) and Urine WBC/ high powered field (hpf) H: >= 2 if PreRx = Missing; >= 2 if PreRx < 2; >= 4 if PreRx >= 2. Crossover study: same participant with MA could be reported in multiple arms.|Day 1 (first dose) to Day of Study Discharge (Day 11 of Treatment Period 3)|All participants who received any study medication and had available laboratory test data were analyzed. n=number of participants evaluated.|||participants|||Number
2608756|NCT02074358|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuation Due to AEs - Treatment Population|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Medical Dictionary for Regulatory Activities (MedDRA) version 17.0 was used.|Day 1 to 30 days Post Last Dose|Treated population: All participants who received at least one dose of study medication were analyzed.|||participants|||Number
2608757|NCT02074358|Secondary|Mean Terminal Elimination Half-Life (T-HALF) of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. T-HALF was measured in hours|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||hours||Standard Deviation|Mean
2608758|NCT02074358|Secondary|Geometric Mean Trough Observed Plasma Concentration at the End of One Dosing Interval (12h) [Cmin] of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. Cmin was measured in nanograms per milliliter (ng/mL).|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2608759|NCT02074358|Secondary|Adjusted Geometric Mean AUC (0-24) for Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability.|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||ng*h/mL||90% Confidence Interval|Geometric Mean
2608760|NCT02074358|Secondary|Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours After Dose Administration [AUC(0-24)] of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. AUC(0-24) was measured in ng*h/mL.|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2608761|NCT02074358|Secondary|Adjusted Geometric Mean AUC (0-12) of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability.|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||ng*h/mL||90% Confidence Interval|Geometric Mean
2608762|NCT02074358|Secondary|Geometric Mean Area Under the Plasma Concentration-Time Curve in One Dosing Interval [AUC(0-12)] of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. AUC(0-12) was measured in ng*hours/mL (ng*h/mL)|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2608763|NCT02074358|Secondary|Geometric Mean Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban on Day 4|Plasma samples for PK analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated LC/MS/MS assay within the period of known analyte stability. Tmax was measured in hours.|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||hours||Full Range|Median
2608764|NCT02074358|Secondary|Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban on Day 4|Plasma samples for pharmacokinetic (PK) analysis were obtained on Day 4 at 0 hour (pre-dose), 0.5, 1, 2, and 3 hours post apixaban dose, and at 0.5, 1, 2, 4, 6, 9 hours post infusion (PCC or Placebo), and at 21, 45, and 69 hours post infusion (Days 5, 6, and 7) in each treatment period. PK parameters were derived from plasma concentration versus time. Concentration of apixaban was determined using a validated liquid chromatography tandem mass spectrometry (LC/MS/MS) assay within the period of known analyte stability. Cmax was measured in nanograms per milliliter (ng/mL).|Day 4|Those participants who received any study medication and had adequate PK profiles were included; 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2608765|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Coagulation Parameter INR From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. INR was measured as a fraction|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||fraction||95% Confidence Interval|Mean
2608766|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Coagulation Parameters PT and aPTT From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Baseline was Day 1, pre-apixaban dose. Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period.|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||seconds||95% Confidence Interval|Mean
2608767|NCT02074358|Primary|PD Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|"ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids. Thrombin concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample. A dedicated software program (Thrombinoscope, Thrombinoscope B.V., Maastricht, The Netherlands) performed the calculations and derived ETP as area under the curve from the resulting thrombogram curve. Pre-dose Apixaban baseline was Day 1 pre-dose (0 hour). Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period."|Day 1 pre-dose apixaban (pre-apixaban Baseline), Day 4 at 30 minutes post infusion (PCC or Placebo)|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||nM*minute||95% Confidence Interval|Mean
2608768|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Velocity Index From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour (pre-dose apixaban). Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA velocity index was measured in nM/min.|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||nM/min||95% Confidence Interval|Mean
2608782|NCT02074345|Primary|Number of Participants With Adverse Reactions Related to Local Reactions|Local Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Local reactions (injection site) were erythema, swelling, induration and pain (tenderness).|For 64 Weeks|FAS included all participants who received at least 1 dose of the study vaccination.|||participants|||Number
2610859|NCT02049307|Primary|Change in Interleukin 6 (IL-6) Plasma Levels From Baseline to 12 Months|Difference between treatment and control IL-6 plasma levels from pre-treatment to on-treatment values|Baseline and 12 months||||pg/mL||Standard Deviation|Mean
2608769|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Lag Time and Time to Peak parameters were measured in minutes.|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||nM||95% Confidence Interval|Mean
2608770|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Lag Time and TGA Time to Peak From Day 1 Pre-Dose Apixaban Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated, automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Baseline was Day 1, 0 hour pre-dose apixaban. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Lag Time and Time to Peak parameters were measured in minutes.|Day 1, pre-dose apixaban (Baseline), Day 4, 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||minutes||95% Confidence Interval|Mean
2608771|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Plasma Anti-Xa Activity From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Anti-FXa activity was measured using a validated method at Esoterix Coagulation Laboratory (Englewood, CO) using the Diagnostica Stago Rotachrom (Registered) Heparin assay on a STA-Compact (Registered) analyzer. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. The results of this chromogenic assay were reported in low molecular weight heparin (LMWH) activity units per milliliter (U/mL), which are equivalent to international units per milliliter (IU/mL) with assay reportable range: 0.1 to 18.4 IU/mL.|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||U/mL||95% Confidence Interval|Mean
2608772|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Coagulation Parameter International Normalized Ratio (INR) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. INR was measured as a fraction.|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||fraction||95% Confidence Interval|Mean
2608773|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in Coagulation Parameters Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|Coagulation parameters were evaluated by Quintiles Laboratories Europe using an ACL TOP analyzer and Instrumentation Laboratory reagents [HemosIL(Registered) Recombiplastin 2G for PT and Synthasil for aPTT]. A second PT was also measured at Esoterix using a Diagnostica Stago STA Compact coagulation analyzer and Diagnostica Stago reagents STA-Neoplastin CI Plus (Registered). Samples on Day 4 were obtained at 0 and 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. PT (Neoplastin CT+), PT (Recombiplastin 2G) and activated partial thromboplastin time (aPTT) parameters were measured in seconds.|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||seconds||95% Confidence Interval|Mean
2608783|NCT02074345|Primary|Number of Participants With Adverse Reactions Related to Body Temperature (Pyrexia)|Body temperature was assessed for 14 days after each vaccination and was recorded by the caregiver in a diary. Adverse reactions related body temperature was reported as pyrexia.|For 64 Weeks|FAS included all participants who received at least 1 dose of the study vaccination.|||participants|||Number
2608784|NCT02074345|Primary|Number of Participants With Adverse Events|Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. Among these, events which are considered possibly associated with a medicinal product are defined as adverse reactions.|For 64 Weeks|Full Analysis Set (FAS) included all participants who received at least 1 dose of the study vaccination.|||participants|||Number
2608774|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Velocity Index From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. TGA Velocity Index parameter was measured in nM per minute (nM/min).|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||nM/min||95% Confidence Interval|Mean
2608775|NCT02074358|Secondary|PD Parameter: Adjusted Mean Change in TGA Peak Height From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. Peak height parameter was measured in nanomolar (nM).|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||nM||95% Confidence Interval|Mean
2608776|NCT02074358|Secondary|PD Parameters: Adjusted Mean Change in TGA Lag Time and Adjusted Mean Change in TGA Time to Peak From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|TGA is a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids and the concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample; dedicated software program was Thrombinoscope, B.V., Maastricht, The Netherlands. Samples on Day 4 were obtained at 0, 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. Lag Time and Time to Peak parameters were measured in minutes.|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion.|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||minutes||95% Confidence Interval|Mean
2608777|NCT02074358|Primary|Pharmacodynamic (PD) Parameter: Adjusted Mean Change in Endogenous Thrombin Potential (ETP) From Day 4 Pre-Infusion (PCC or Placebo) Baseline at Day 4, 30 Minutes Post Infusion of PCC or Placebo|"ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex vivo assay performed on platelet-poor plasma samples and based on the automated, calibrated thrombin generation method: thrombin formation was triggered with recombinant tissue factor and phospholipids. Thrombin concentration in each sample was calculated over time by measuring the cleavage of a fluorogenic substrate in the context of a paired calibration sample. Dedicated software (Thrombinoscope, Thrombinoscope B.V., Maastricht, The Netherlands) performed the calculations and derived ETP as area under the curve from the resulting thrombogram curve. Pre-infusion baseline= sample on Day 4, 3 hours post apixaban dose (just prior to IV infusion of PCC or placebo). Samples on Day 4 were obtained at 0 (pre-dose), 0.5, 1, 2, 3 hours post apixaban dose and at 0.5, 1, 2, 4, 6, 9, 21, 45, and 69 hours post infusion (PCC or Placebo) in each treatment period. ETP was measured as nanomolar*minute (nM*min)."|Day 4 at 3 hours post apixaban dose and prior to infusion (Pre-infusion Baseline), Day 4 at 30 minutes post infusion (PCC or Placebo)|PD Population included all participants who received any study medication and had PD data available for at least the analysis-specified baseline and 30 minutes after the start of the study drug infusion. 1 participant who received a partial PCC dose (approximately 2 IU/kg) was excluded from this summary analysis.|||nM*min||95% Confidence Interval|Mean
2608778|NCT02074345|Secondary|Geometric Mean Titer (GMT) of Anti-PRP Antibody|Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Hib as an assessment of immunogenicity.|For 64 weeks|FAS, all participants who received at least 1 dose of the study vaccination, with available data.|||μg/mL||95% Confidence Interval|Geometric Mean
2608779|NCT02074345|Secondary|Percentage of Participant With Anti-PRP Antibody Titer ≥ 0.15 μg/mL|Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Hib as an assessment of immunogenicity.|For 64 weeks|FAS, all participants who received at least 1 dose of the study vaccination, with available data.|||percentage of participants||95% Confidence Interval|Number
2608780|NCT02074345|Secondary|Percentage of Participant With Anti-PRP Antibody Titer ≥ 1.0 μg/mL|Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Haemophilus influenzae type b (Hib) as an assessment of immunogenicity.|For 64 weeks|FAS, all participants who received at least 1 dose of the study vaccination, with available data.|||percentage of participants||95% Confidence Interval|Number
2608781|NCT02074345|Primary|Number of Participants With Adverse Reactions Related to Systemic Reactions|Systemic Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Systemic reactions were rash, irritability, crying, decreased appetite, vomiting, diarrhoea, somnolence (sleepiness) and insomnia (sleeplessness).|For 64 Weeks|FAS included all participants who received at least 1 dose of the study vaccination.|||participants|||Number
2608790|NCT02073968|Secondary|Progression-free Survival Assessed Using the RECIST Criteria|Kaplan-Meier survival plots will be produced. The survival probabilities will be presented. Log-rank testing will be used to compare the survival probabilities between categorical predictors. A Cox regression model will be used to estimate the hazard rates for progression free survival among the predictor variables.|From study registration to date of disease progression or death, censored at the date of data collection, assessed up to 5 years|||||||
2608791|NCT02073968|Secondary|Overall Survival|Kaplan-Meier survival plots will be produced. The survival probabilities will be presented. Log-rank testing will be used to compare the survival probabilities between categorical predictors. A Cox regression model will be used to estimate the hazard rates for overall survival among the predictor variables.|From study registration to death, censored at the date of data collection, assessed up to 5 years|||||||
2608792|NCT02073968|Secondary|Lung Cancer Cause-specific Survival|A patient will be considered to have died from lung cancer if he or she had evidence of disease progression at any site and no direct evidence of other cause of death. Kaplan-Meier survival plots will be produced.|From study registration to death directly from lung cancer, censored at the date of data collection, assessed up to 5 years|||||||
2608793|NCT02073968|Secondary|Locoregional Progression-free Survival Assessed Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Kaplan-Meier survival plots will be produced. The survival probabilities will be presented. Log-rank testing will be used to compare the survival probabilities between categorical predictors. A Cox regression model will be used to estimate the hazard rates for progression free survival among the predictor variables.|From study registration to date of local or regional disease progression or death, censored at the date of data collection, assessed up to 5 years|||||||
2608794|NCT02073968|Secondary|Incidence of Grade >= 3 Treatment-related Toxicity, Scored Using CTCAE, v. 4|The safety parameters will be presented as frequency and percentages.|Up to 5 years|||||||
2608795|NCT02073968|Secondary|Incidence of Grade >= 2 Radiation-induced Lung Toxicity, Scored Using Common Terminology Criteria for Adverse Events (CTCAE), Version (v.) 4|The safety parameters will be presented as frequency and percentages.|Up to 5 years|||||||
2608796|NCT02073968|Primary|Metabolic Response of All Pulmonary Lesions and Thoracic Lymph Nodes|Favorable response will be defined as having maximum SUV less than 6.0 on post-treatment PET/CT.|Up to 16 weeks after completion of radiation therapy||||Participants|||Count of Participants
2608797|NCT02073929|Other Pre-specified|Change in Serum Levels of Anti-Müllerian Hormone|measured as pmol/l|at time 0 and 26 weeks|missing one participant in placebo group|||pmol/ml||95% Confidence Interval|Mean
2608798|NCT02073929|Other Pre-specified|Change in Ovarian Volume Between Baseline and Follow up (26 Weeks)|measured as ml|at time 0 and 26 weeks|not measured in all participants, one is missing in each group|||ml||95% Confidence Interval|Mean
2608799|NCT02073929|Other Pre-specified|Change in Body Composition (VAT)|cubic cm|at time 0 and 26 weeks|not measured on all subjects (missing. 4 in Liraglutide and one in placebo Group)|||cubic cm||Standard Deviation|Mean
2608800|NCT02073929|Other Pre-specified|Change in Percent Liver Fat Content|percent liver fat content|at time 0 and 26 weeks|only participants with measurable i.e. >5% liver fat at baseline was included in this analysis|||percentage of liver fat||Standard Deviation|Mean
2608801|NCT02073929|Other Pre-specified|Change in Bleeding Pattern (Bleeding Ratio)|Ration between number of bleedings during 3 months before trial and last 3 months of trial|at time 0 and 26 weeks||||n of bleedings/n of expected bleedings||Inter-Quartile Range|Median
2608802|NCT02073929|Other Pre-specified|Percent Change in Plasma Level of High Sensitivity C-reactive Protein (CRP)|percent change from baseline|at time 0 and 26 weeks||||percent change in CRP levels||Inter-Quartile Range|Mean
2608803|NCT02073929|Other Pre-specified|Change in Plasma Level of Copeptin||at time 0 and 26 weeks|measured as pmol/l|||pmol/l||Full Range|Median
2608804|NCT02073929|Other Pre-specified|Change in Plasma Level of Atrial Natriuretic Peptide (ANP)|measured in pmol/l|at time 0 and 26 weeks||||pmol/l||Inter-Quartile Range|Median
2608805|NCT02073929|Other Pre-specified|Change in Plasma Level of Adrenomedullin|measured in nmol/l|at time 0 and 26 weeks||||nmol/l||Inter-Quartile Range|Median
2608806|NCT02073929|Secondary|Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1||at time 0 and 26 weeks||||percent change in plasma PAI-1||95% Confidence Interval|Mean
2608807|NCT02073929|Primary|Change in Endogenous Thrombin Potential (ETP)|Area under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min|at time 0 and 26 weeks||||nMolar x minutes||95% Confidence Interval|Mean
2608808|NCT02073747|Primary|Number of Subjects With a Change From Baseline Serum Lactate Following a One Hour Albuterol Nebulizer Treatment.|We powered our study to detect a difference of 0.5 mmol/L between pre and post-treatment lactate levels, but hypothesize that the difference will be greater than 1.0 mmol/L.|Change in serum lactate from baseline to 1 hour||||mmol/L||95% Confidence Interval|Mean
2608809|NCT02073682|Secondary|Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death||12 months|mITT (Safety Analysis Set)|||Participants|||Count of Participants
2608810|NCT02073682|Secondary|Number of Participants With VTE-Related Death||12 months|mITT (Safety Analysis Set)|||Participants|||Count of Participants
2608811|NCT02073682|Secondary|Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period||12 months|mITT (Safety Analysis Set)|||Participants|||Count of Participants
2608812|NCT02073682|Secondary|Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period||12 months|mITT (Safety Analysis Set)|||Participants|||Count of Participants
2608813|NCT02073682|Secondary|Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period||12 months|mITT (Safety Analysis Set)|||Participants|||Count of Participants
2608814|NCT02073682|Secondary|Number of Participants With Adjudicated Major Bleeding Events While on Treatment|The primary safety endpoint was major bleeding events during the On-Treatment Study Period (defined as on-study drug or up to 3 days after the last dose of study drug).|12 months|Safety analysis set|||Participants|||Count of Participants
2608815|NCT02073682|Primary|Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event||12 months|modified Intent to Treat (mITT), equating to the Safety Analysis Set|||Participants|||Count of Participants
2608816|NCT02073656|Secondary|For Participants in the Retreatment Substudy, Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24 of Retreatment Substudy|Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.|||percentage of participants|||Number
2608817|NCT02073656|Secondary|For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8||Baseline; Weeks 2, 4, and 8 of Retreatment Substudy|Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2608818|NCT02073656|Secondary|For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24||Weeks 2, 4, 8, 12, 16, 20, and 24 of the Retreatment Substudy|Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.|||percentage of participants||95% Confidence Interval|Number
2608819|NCT02073656|Secondary|For Participants in the Retreatment Substudy, Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)|SVR4, SVR12, and SVR 24 were defined as HCV RNA < LLOQ at 4, 12, and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4, 12, and 24 of Retreatment Substudy|Participants in the Full Analysis Set who entered the Retreatment Substudy were analyzed.|||percentage of participants||95% Confidence Interval|Number
2608820|NCT02073656|Secondary|Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24||Baseline; Week 12, Posttreatment Weeks 12 and 24|Participants in the Safety Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
2608821|NCT02073656|Secondary|Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment||Weeks 4, 8, and 12|Participants in the Safety Analysis Set with available data were analyzed.|||percentage of participants|||Number
2608822|NCT02073656|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2608823|NCT02073656|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8||Baseline; Weeks 1, 2, 4, 6, and 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2608824|NCT02073656|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12||Weeks 1, 2, 4, 6, 8, 10, and 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2608825|NCT02073656|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2608826|NCT02073656|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2608827|NCT02073656|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who enrolled and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2608828|NCT02073643|Other Pre-specified|Change From Baseline in Body Mass Index at 12 Months|Change in body mass index over 12 months of follow up|12 months|N=180 participants completed the 12-month follow up assessment|||difference in kg/m^2||Standard Deviation|Mean
2608829|NCT02073643|Other Pre-specified|Change From Baseline in Systolic Blood Pressure at 12 Months|Change in systolic blood pressure|12 months|N=179 participants had blood pressure readings at both baseline and the 12-month follow up.|||change in mmHg, systolic||Standard Deviation|Mean
2608830|NCT02073643|Secondary|Percentage of Total Energy Purchased From Non-store Sources (e.g., Fast Food and Take-out/Delivery, Restaurants)|Percentage of total energy (kcal) purchased from all sources other than food stores/supermarkets, including fast food and take-out/delivery, full-service restaurants, vending machines, bars/taverns, and cafeterias.|2 weeks|N=202 subjects had food purchase data available for analysis|||Percentage of total energy purchased||Inter-Quartile Range|Median
2608831|NCT02073643|Secondary|Home Food Environment|"Availability of obesity promoting foods in the home, assessed with an audit-based inventory. The audit captures the presence of 71 obesity promoting foods. The sum of these items ranges from 0-71, with higher scores reflecting greater availability in the home."|2 weeks||||units on a scale||Standard Deviation|Mean
2608832|NCT02073643|Secondary|Diet Quality of Dietary Intake|Diet quality was quantified by applying the Healthy Eating Index-2015 (HEI-2015) scoring criteria (https://epi.grants.cancer.gov/hei/) to the nutrient and food group data derived from three 24-hour diet recalls. The HEI-2015 scores adherence to the Department of Health and Human Services' 2015 Dietary Guidelines for Americans. Adherence to recommended intakes for 13 key dietary components is scored on continuous scale for each component, and the 13 component scores are then summed to obtain a total score ranging from 0-100. Higher scores reflect closer adherence to the dietary guidelines.|2 weeks||||units on a scale||Standard Deviation|Mean
2608866|NCT02073162|Primary|Number of Participants With Disability-free Survival|"Disability was defined as a persistent impairment in health status (lasting ≥6 months), as measured by a score of at least 24 points on the WHODAS questionnaire, which reflects a disability level of at least 25% (the threshold point between disabled and not disabled)."|1 year||||Participants|||Count of Participants
2608833|NCT02073643|Primary|Diet Quality of Household Food Purchases|Diet quality was quantified by applying the Healthy Eating Index-2015 (HEI-2015) scoring criteria (https://epi.grants.cancer.gov/hei/) to the nutrient and food group data of purchased foods and beverages. The HEI-2015 scores adherence to the Department of Health and Human Services' 2015 Dietary Guidelines for Americans. Adherence to recommended intakes for 13 key dietary components is scored on continuous scale for each component, and the 13 component scores are then summed to obtain a total score ranging from 0-100. Higher scores reflect closer adherence to the dietary guidelines.|2 weeks|N=202 participants had food purchase data available for analysis.|||units on a scale||Standard Deviation|Mean
2608834|NCT02073565|Other Pre-specified|Number of Patients Exhibiting Human Antimurine Antibody (HAMA) Reaction|Serum will be assessed for HAMA development at index, 30 days, and 12 months in Cohort B subjects. Human antimurine antibody plasma assessment will be with blood draws performed during index procedure, 30 day follow-up visit, and 1 year catheterizations.|Day of device implantation, 30 days, 12 months|"Cohort B - Please note that for the 1 Year HAMA Responders Row in the Combo arm, 52 participants were analyzed (1 participant withdrew and 1 participant died). For the 1 Year HAMA Responders Row in the EES arm, 52 participants were analyzed (2 participants withdrew and 2 participants were not present for the 1 year visit)."|||Participants|||Count of Participants
2608835|NCT02073565|Other Pre-specified|Number of Patients With Clinically and Functionally Ischemia-Driven Target Lesion Revascularization (TLR)|Clinically and functionally ischemia-driven target lesion revascularization (TLR), including use of target-vessel Fractional Flow Reserve (FFR), analyzed dichotomously using the Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation (FAME) study criteria of 0.8 during a 2 minute infusion of adenosine or adenosine triphosphate.34 Abnormal FFR-driven interventions at 1 year will be included in the evaluation of ischemia-driven TLR.|1 year||||Participants|||Count of Participants
2608836|NCT02073565|Secondary|Percentage of Healthy Tissue Coverage That Was Greater Than 40 Micrometers|The secondary efficacy endpoint is mechanistic Optical coherence tomography (OCT) healthy level of intimal tissue coverage, determined by the OCT core laboratory at 1 year for subjects in Cohorts A and B. This reports the percentage of healthy tissue coverage that was great than 40 micrometers.|1 year|Cohorts A and B - Subjects with analyzable Optical coherence tomography (OCT) follow-up|||Healthy Tissue Strut Coverage (>40 µm) %|lesions|95% Confidence Interval|Mean
2608837|NCT02073565|Primary|Number of Participants With Target Vessel Failure (TVF)|The primary clinical endpoint of Target Vessel Failure (TVF), defined as cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven Target Vessel Revascularization(TVR) by percutaneous or surgical methods, at 1 year.|1 year follow-up||||Participants|||Count of Participants
2608838|NCT02073461|Secondary|Local Tolerability (Stinging/Burning)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
2608839|NCT02073461|Secondary|Local Tolerability (Pruritus)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
2608840|NCT02073461|Secondary|Local Tolerability (Dryness)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
2608841|NCT02073461|Secondary|Local Tolerability (Scaling)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
2608842|NCT02073461|Secondary|Local Tolerability (Erythema)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
2608843|NCT02073461|Secondary|Percent of Subjects With Adverse Events|Adverse events which were observed in 5% or more patients with either group are listed.|up to 12 weeks||||percentage of participants|||Number
2608844|NCT02073461|Primary|Percent Changes From Baseline in Total Lesion Counts|Median percent reductions from Baseline in total lesion count (ITT-LOCF)|Baseline - Week 12||||percent change||Full Range|Median
2608845|NCT02073448|Secondary|Local Tolerability (Stinging/Burning)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
2608846|NCT02073448|Secondary|Local Tolerability (Pruritus)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
2608847|NCT02073448|Secondary|Local Tolerability (Dryness)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
2608848|NCT02073448|Secondary|Local Tolerability (Scaling)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
2608849|NCT02073448|Secondary|Local Tolerability (Erythema)|Highest severity of local tolerability scores worse than Baseline|12 weeks||||participants|||Number
2608850|NCT02073448|Secondary|Percent of Subjects With Adverse Events||up to 12 weeks||||percentage of participants|||Number
2608851|NCT02073448|Primary|Percent Changes From Baseline in Total Lesion Counts||Baseline - Week12||||percent change||Full Range|Median
2608852|NCT02073435|Primary|Complications|Cardiopulmonary complications|Perioperatively||||Cardiopulmonary complications|||Number
2608853|NCT02073435|Primary|Living Donor Pain Management|"Comparison of Average Pain Scores on Visual Analogue Pain Scale (0-10) measured before and after implementation of evidence-based donor pain management solution. 0 representing No Pain, up through 10 representing Worst possible, unbearable, excruciating pain."|Daily Visual Analogue Pain Scores (0-10) At transplant (post-operative day 0) and throughout hospitalization (post-operative days 1-8)||||Scores on Visual Analogue Pain Scale||Standard Deviation|Mean
2608854|NCT02073331|Primary|Proportion of Subjects With Device Related Adverse Events.|Data will be collected at the initial post-operative visit. This is a single visit study.|Post-op visit, after an average of 30 days||||Proportion of subjects||95% Confidence Interval|Number
2608855|NCT02073162|Secondary|Death||12 month||||Participants|||Count of Participants
2608856|NCT02073162|Secondary|Death||90 days||||Participants|||Count of Participants
2608857|NCT02073162|Secondary|Number of Participants With Unplanned Admission to ICU||30 day||||Participants|||Count of Participants
2608858|NCT02073162|Secondary|Number of Participants With Pulmonary Edema||Indexed hospital stay||||Participants|||Count of Participants
2608859|NCT02073162|Secondary|Number of Participants Undergoing Renal-replacement Therapy||Indexed hospital stay||||Participants|||Count of Participants
2608860|NCT02073162|Secondary|Number of Participants With Pneumonia||Indexed hospital stay||||Participants|||Count of Participants
2608867|NCT02072980|Secondary|Average Coefficient of Friction at 15 Minutes|Worn contact lenses were removed from the participant's eye and the CF was calculated. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.|Day 1 (for each period), 15 minutes|This analysis population includes all participants who completed the study.|||unitless||Standard Deviation|Mean
2608868|NCT02072980|Primary|Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn|Worn contact lenses were removed from the participant's eye. The CF was calculated and compared to the CF for unworn contact lenses. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.|Day 1 (for each period), 16 hours|This analysis population includes all participants who completed the study.|||unitless||Standard Deviation|Mean
2608869|NCT02072941|Secondary|Self-reported Engagement in Advance Care Planning Behaviors|"Secondary outcomes were chosen to measure the full process of Advance Care Planning (ACP) using validated questionnaires, such as the patient-reported ACP Engagement Survey. This questionnaire includes both Behavior Change Process and ACP Action measures. Behavior Change Process measures include knowledge, contemplation, self-efficacy, and readiness for several ACP actions. The Process measures are assessed on an average 5-point Likert scale with a low of 1 and a high of 5, with high scores indicating more ACP engagement. Action measures include ACP actions such as identifying a surrogate decision-maker, identifying values and goals for medical care, choosing the level of leeway in surrogate decision-making, discussing one's wishes with clinicians and surrogates, and documenting one's wishes in an advance directive. Action measures use yes or no response options and are measured on a 0- to 25-point scale, where 0 is no action and 25 means they have engaged in more ACP actions."|12 months||||score on a scale||Standard Deviation|Mean
2608870|NCT02072941|Primary|New Advance Care Planning Documentation in the Medical Record at 15 Months|The primary outcome is documentation of advance care planning wishes in the medical record. ACP documentation for the purposes of this study includes the easy-to-read advance directive or other valid advance directives or living wills, a durable power of attorney for healthcare document (DPOAHC), a physicians orders for life sustaining treatment (POLST) form, or other documentation of patients wishes for medical care (ie, documentation of oral directives by a physician, or code status, such as full code or do not resuscitate or do not intubate orders or notes by a physician).|15 months after study enrollment||||Participants|||Count of Participants
2608871|NCT02072928|Primary|Change From Baseline in Anticholinergic Drug Use|Anticholinergic drug use was collected the 9 months before the baseline Botox® treatment and the 9 months following the baseline Botox® treatment. Total anticholinergic drug use in the 9 months following the baseline Botox® treatment is noted.|Baseline, 9 Months|Treatment responders for whom pharmacy data is available|||Doses of Anticholinergic Drugs||Standard Error|Mean
2608872|NCT02072824|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for abnormalities in ECG findings: 1) Time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS complex): >=140 milliseconds (msec); 2) The interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=200 msec; 3) Time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTCF interval): absolute value 450 to <480 msec, 480 to <500 msec, >=500 msec; 4) Maximum QT interval: >=500 msec; 5) Maximum QTCB interval (Bazett's correction): 450 to< 480 msec, 480 to <500 msec, >=500 msec. Only those categories of ECG abnormalities in which participants were found abnormal (maximum QTCB interval 450-<480 msec), were reported in this outcome measure.|From screening up to EOS (maximum Day 25)|Safety population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2608873|NCT02072824|Other Pre-specified|Percentage of Participants With Abnormal Neurological Examination Findings at Baseline and End of Study|Neurological examinations included: coordination; cranial nerve function (CNF); gait and station; level of consciousness (LOC); lower and upper extremity sensation; muscle strength; muscle tone; nystagmus; reflexes and speech. Abnormalities in neurological examination were based on investigator's discretion and also, some components of the neurological examination were not done for certain participants due to participant age or significant developmental impairment. Only those categories of neurological examination in which at least 10% of participants had an abnormality in any treatment group at any time point were reported in this outcome measure.|Baseline (BL) and EOS (maximum Day 25)|"Safety population included all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies number of participants who were evaluable for the specified category for each arm respectively."|||percentage of participants|||Number
2608874|NCT02072824|Other Pre-specified|Percentage of Participants With Abnormal Physical Examination Findings at Screening and End of Study|Physical examinations evaluated the following body systems/organs: abdomen; ears; extremities; eyes; general appearance; head; heart; lungs; lymph nodes; mouth; musculoskeletal; nose; skin and throat. Abnormalities in physical examination were based on investigator's discretion.|Screening and EOS (maximum Day 25)|"Safety population included all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies number of participants who were evaluable for the specified category for each arm respectively."|||percentage of participants|||Number
2608875|NCT02072824|Other Pre-specified|Number of Participants With Vital Signs Abnormalities|Criteria for abnormalities in vital signs included: sitting/supine systolic blood pressure (SBP) values: maximum increase and decrease of greater than or equal to (>=) 30 millimeter of mercury (mmHg) from baseline; sitting/supine diastolic blood pressure (DBP) value: maximum increase and decrease of >=20 mmHg from baseline.|From Baseline (BL) up to EOS (maximum Day 25)|Safety population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2608886|NCT02072668|Secondary|Change in Ratio From Baseline to Week 4 in AH/AO|Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variables measured: hyperemia area (AH) and occlusion area (AO)|Baseline, 4 weeks|All participants randomized to each treatment were analyzed.|||ratio of AH to AO||95% Confidence Interval|Mean
2610267|NCT02057952|Secondary|Change in SF 36 From Baseline to 6 Months|The Short Form 36 survey or Short-Form 36 is a patient report survey. Scores range from 0 (worst) to 100 (best) and represent overall health-related quality of life.|6 Months||||units on a scale||Standard Deviation|Mean
2608876|NCT02072824|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities|Abnormality Criteria: hemoglobin,hematocrit,red blood cells(RBC)count:<0.8*lower limit of normal[LLN],platelets:<0.5*LLN/>1.75*upper limit of normal[ULN]; leukocytes:<0.6*LLN/>1.5*ULN; lymphocytes,neutrophils, total protein,albumin, tetraiodothyronine,thyroid stimulating hormone:<0.8*LLN/>1.2*ULN; basophils,eosinophils,monocytes:>1.2*ULN; prothrombin [PT],PT international ratio:>1.1*ULN; aspartate aminotransferase,alanine aminotransferase,alkaline phosphatase,gamma glutamyl transferase:>0.3*ULN; bilirubin:>1.5*ULN; blood urea nitrogen,creatinine, cholesterol,triglycerides:>1.3*ULN; sodium: <0.95*LLN/>1.05*ULN; potassium,chloride,calcium,bicarbonate:<0.9*LLN/>1.1*ULN; glucose fasting:<0.6*LLN/>1.5*ULN; creatine kinase:>2*ULN;urine glucose,ketone,protein:>=1;urine WBC,RBC:>= 20/High Power Field[HPF]; urine casts,hyaline casts:>1/Low Power Field; urine bacteria:>20/HPF.|From Baseline up to EOS (maximum Day 25)|"Safety population included all randomized participants who received at least 1 dose of study drug. Here, Overall number of participants analyzed= number of participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2608877|NCT02072824|Other Pre-specified|Number of Adverse Events by Severity|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild: AEs does not interfere with participant's usual function b) moderate: AEs interferes to some extent with participant's usual function c) severe: AEs interferes significantly with participant's usual function.|Day 1 up to EOS (maximum Day 25)|Safety population included all randomized participants who received at least 1 dose of study drug.|||events|||Number
2608878|NCT02072824|Other Pre-specified|Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to drug was assessed by the investigator. AEs included both serious and non-serious adverse events.|Day 1 up to EOS (maximum Day 25)|Safety population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2608879|NCT02072824|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.|Day 1 up to End of study (EOS) (maximum Day 25)|Safety population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2608880|NCT02072824|Secondary|Responder Rate: Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase|Responder Rate was defined as percentage of participants who had a 50% or greater reduction from baseline in 24-hour seizure rate during the double-blind treatment phase. Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment.|Day 1 up to Day 14|mITT population included all randomized participants who took at least one dose of study drug during the double-blind treatment phase, had a baseline with at least one partial onset seizure identified by Video-EEG (at least 24 hours of evaluable monitoring) and a treatment phase Video-EEG.|||percentage of participants|||Number
2608881|NCT02072824|Primary|Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase|"All partial onset seizures experienced during treatment phase were recorded by central reader during the 48 to 72 hour video-electroencephalogram (EEG). Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment. For log-transformation, the quantity 1 was added to the double blind 24 hour EEG seizure rate for all participants to account for any possible 0 seizure incidence. This resulted in final calculation as: log transformed (double-blind 24-hour EEG seizure rate + 1)."|Day 1 up to Day 14|Modified intent-to-treat (mITT) population included all randomized participants who took at least one dose of study drug during the double-blind treatment phase, had a baseline with at least one partial onset seizure identified by video-EEG (at least 24 hours of evaluable monitoring) and a treatment phase video-EEG.|||seizures per 24 hours||Standard Error|Least Squares Mean
2608882|NCT02072668|Secondary|Change From Baseline to Week 4 in D-Dimer|Assay for D--dimer is performed using commercially available enzyme-linked immunosorbent assay (ELISA).|Baseline, 4 weeks|Data reported only for those participants who completed both interventions.|||ng/mL||95% Confidence Interval|Mean
2608883|NCT02072668|Secondary|Change From Baseline to Week 4 in TAT|Assay for thrombin antithrombin (TAT) complexes performed using commercially available enzyme-linked immunosorbent assay (ELISA).|Baseline, 4 weeks|Data reported only for those participants who completed both interventions.|||ug/mL||95% Confidence Interval|Mean
2608884|NCT02072668|Secondary|Change From Baseline to Week 4 in RF|Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: rest flow (RF)|Baseline, 4 weeks|All participants randomized to each treatment were analyzed.|||perfusion units||95% Confidence Interval|Mean
2608885|NCT02072668|Secondary|Change From Baseline to Week 4 in PF|Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: peak flow (PF)|Baseline, 4 weeks|All participants randomized to each treatment were analyzed.|||perfusion units||95% Confidence Interval|Mean
2608887|NCT02072668|Secondary|Change From Baseline to Week 4 in AH|Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: hyperemia area (AH)|Baseline, 4 weeks|All participants randomized to each treatment were analyzed.|||perfusion units*seconds||95% Confidence Interval|Mean
2608888|NCT02072668|Secondary|Change From Baseline to Week 4 in TM|Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: time to max (TM)|Baseline, 4 weeks|All participants randomized to each treatment were analyzed.|||seconds||95% Confidence Interval|Mean
2608889|NCT02072668|Secondary|Change From Baseline to Week 4 in TH1|Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: time to half before hyperemia (TH1)|Baseline, 4 weeks|All participants randomized to each treatment were analyzed.|||seconds||95% Confidence Interval|Mean
2608890|NCT02072668|Secondary|Change From Baseline to Week 4 in Marker of Endothelial Cell (EC) Activation sICAM|levels of soluble intracellular adhesion molecule (sICAM) were measured using a commercially available ELISA|Baseline, 4 weeks|Biomarker evaluations were limited to VCAM-1 and IL-6 as those were thought more likely to reflect endothelial cell activation based on experience in recent studies.||||||
2608891|NCT02072668|Secondary|Change From Baseline to Week 4 in Plasma Marker of Inflammation sPLA2|secretory phospholipase A2 (sPLA2) was measured using Luminex MAP technology at the UNC core facility|Baseline, 4 weeks|Biomarker evaluations were limited to IL-2 and IL-8 as those were thought more likely to reflect inflammation activation based on experience in recent studies.||||||
2608892|NCT02072668|Secondary|Change From Baseline to Week 4 in Plasma Marker of Inflammation TNF-a|tumor necrosis factor alpha (TNF-a) was measured using Luminex MAP technology at the UNC core facility.|Baseline, 4 weeks|Biomarker evaluations were limited to IL-2 and IL-8 as those were thought more likely to reflect inflammation activation based on experience in recent studies.||||||
2608893|NCT02072668|Secondary|Change From Baseline to Week 4 in Plasma Marker of Inflammation MPO|myeloperoxidase (MPO) was measured using Luminex MAP technology at the UNC core facility.|Baseline, 4 weeks|Biomarker evaluations were limited to IL-2 and IL-8 as those were thought more likely to reflect inflammation activation based on experience in recent studies.||||||
2608894|NCT02072668|Secondary|Change From Baseline to Week 4 in Plasma Marker of Inflammation hsCRP|high sensitivity C-reactive protein (hsCRP) was measured using Luminex MAP technology at the UNC core facility.|Baseline, 4 weeks|Biomarker evaluations were limited to IL-2 and IL-8 as those were thought more likely to reflect inflammation activation based on experience in recent studies.||||||
2608895|NCT02072668|Secondary|Change From Baseline to Week 4 in the Plasma Marker of Inflammation IL-8|Interleukin-8 (IL-8) was measured using Luminex MAP technology at the UNC core facility|Baseline, 4 weeks|Data analyzed for the 13 participants completing both interventions but results for 4 participants in the rivaroxaban group and 5 participants in the placebo group fell outside the standard curve and could not be extrapolated.|||pg/mL||95% Confidence Interval|Mean
2608896|NCT02072668|Secondary|Change From Baseline to Week 4 in the Plasma Marker of Inflammation IL-2|Interleukin-2 (IL-2) was measured using Luminex MAP technology at the UNC core facility|Baseline, 4 weeks|Data analyzed for the 13 participants completing both interventions but results for 6 participants in each group fell outside the standard curve and could not be extrapolated.|||pg/mL||95% Confidence Interval|Mean
2608897|NCT02072668|Primary|Change From Baseline to 4 Weeks in Interleukin-6 (IL-6)|Assay performed for IL-6 using a commercially available enzyme-linked immunosorbent assay (ELISA).|Baseline, 4 weeks|Data reported only for those participants who completed both interventions.|||pg/mL||95% Confidence Interval|Mean
2608898|NCT02072668|Primary|Change From Baseline to 4 Weeks in Soluble Vascular Cell Adhesion Molecule-1 (VCAM-1)|Assay performed for soluble VCAM-1 using a commercially available enzyme-linked immunosorbent assay (ELISA).|Baseline, 4 weeks|Data reported only for those participants who completed both interventions.|||pg/mL||95% Confidence Interval|Mean
2608899|NCT02072434|Secondary|Percentage of Participants With Composite Endpoints of Stroke, SEE, MI, CV Mortality, and Major Bleeding||From randomization to the end of follow-up (within 2 years)|This outcome was assessed in the ITT Analysis Set.|||Percentage of participants|||Number
2608900|NCT02072434|Primary|Percentage of Participants With Composite Endpoints of Major and Clinically-relevant Non-major (CRNM) Bleeding||During treatment period (within 2 years)|This outcome was assessed in the Safety Analysis Set.|||Percentage of participants|||Number
2608901|NCT02072434|Primary|Percentage of Participants With Composite Endpoint of Stroke, Systemic Embolic Stroke (SEE), Myocardial Infarction (MI) and Cardiovascular (CV) Mortality From Randomization to End of Follow up||Randomization to end of follow-up (within 2 years)|This outcome was assessed in the Intent-to-Treat (ITT) Analysis Set.|||Percentage of participants|||Number
2608902|NCT02072421|Secondary|Major Vascular Complications|Major vascular complications, including access site complications and major bleeding events requiring transfusion,through 30 days post-procedure.|30 days||||participants|||Number
2608903|NCT02072421|Secondary|Revascularization|Repeat coronary revascularization including emergency or urgent revascularization through 30 days post-procedure|30 days||||participants|||Number
2608904|NCT02072421|Secondary|Stroke|Stroke through 30 days post-procedure|30 days||||participants|||Number
2608905|NCT02072421|Secondary|All-Cause Mortality|all-cause mortality through 30 days post-procedure|30 days||||participants|||Number
2608906|NCT02072421|Primary|Major Adverse Cardiac Event (MACE)|MACE is a composite of all cause mortality, myocardial infarction (Q wave and non-Q wave), repeat coronary revascularization (of the target vessel or non-target vessel) by either percutaneous or coronary artery bypass graft (CABG) methods, or stroke, at 30-days.|30-days||||participants|||Number
2608958|NCT02071849|Secondary|NYHA Functional Capacity Classification|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|2 years postprocedure|Participants with an evaluation of this measure.|||Participants|||Count of Participants
2608907|NCT02072226|Secondary|Percentage of Participants With Serious Adverse Events|A serious adverse event (SAE) was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.|From baseline to Day 90|Safety Population included all participants, who received any amount of study drug.|||percentage of participants|||Number
2608908|NCT02072226|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|From baseline up to Day 90: Non-serious adverse events were collected through the Day 30 visit. Serious adverse events were collected through the end of study at Day 90.|Safety Population included all participants, who received any amount of study drug.|||percentage of participants|||Number
2608909|NCT02072226|Secondary|Percentage of Participants Who Died Due to Stroke and Neurological Disorders|Reported here is the percentage of participants who died due to stroke and neurological disorders.|From baseline to Day 90|Safety Population included all participants, who received any amount of study drug.|||percentage of participants|||Number
2608910|NCT02072226|Secondary|Overall Mortality|Reported here is the percentage of participants who died due to any cause during the study.|From baseline to Day 90|Safety Population included all participants, who received any amount of study drug.|||percentage of participants|||Number
2608911|NCT02072226|Secondary|Percentage of Participants With Any ICH|To detect ICH, neuroimaging (CT or MRI) scan was performed at 22 to 36 hours after study drug administration.|Within 36 hours after study drug administration on Day 1|Safety Population included all participants, who received any amount of study drug.|||percentage of participants|||Number
2608912|NCT02072226|Secondary|Percentage of Participants With Symptomatic Intracranial Hemorrhage (ICH )|ICH was considered symptomatic if it was not seen on computed tomography (CT) or magnetic resonance imaging (MRI) scan at baseline and any neurologic decline was attributed to it by the local investigator. To detect intracranial hemorrhage, neuroimaging (CT or MRI) scan was performed at 22 to 36 hours after study drug administration.|Within 36 hours after study drug administration on Day 1|Safety Population included all participants, who received any amount of study drug.|||percentage of participants|||Number
2608913|NCT02072226|Secondary|Percentage of Participants With Global Favorable Recovery on mRS, NIHSS, BI, and GOS|Global favorable recovery is an integrated assessment of participants who meet the following: mRS Score 0−1, National Institutes of Health Stroke Scale (NIHSS) Score 0−1, Barthel Index [BI] greater than or equal to 95, and Glasgow Outcome Scale [GOS] equal to 1. mRS Score 0−1: 0= No symptoms at all, 1= No significant disability despite symptoms, able to carry out all usual duties and activities. NIHSS Score 0-1: 0= No stroke symptoms and 1= Minor stroke symptoms. BI is a 10 question index with a total score range of 0-100 with 100 being the best outcome. GOS =1: Good recovery. Reported here are the percentages of participants who achieved a favorable score on each of these scales.|Day 90|ITT population included all randomized participants.|||percentage of participants|||Number
2608914|NCT02072226|Secondary|Distribution of Participants Across the Ordinal mRS|mRS score was determined by the investigator. The mRS is a 7 point scale (0-6) with 0: No symptoms at all, 1: No significant disability despite symptoms, able to carry out all usual duties and activities, 2: Slight disability, unable to carry out all previous activities but able to look after own affairs without assistance, 3: Moderate disability requiring some help, but able to walk without assistance, 4: Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance, 5: Severe disability, bedridden, incontinent and requiring constant nursing care and attention, 6: death before Day 90. Reported are the percentages of participants for all scores on the mRS.|Day 90|ITT population included all randomized participants.|||percentage of participants|||Number
2608915|NCT02072226|Primary|Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 or 1 at Day 90|mRS score was determined by the investigator. The mRS is a 7 point scale (0-6) with 0: No symptoms at all, 1: No significant disability despite symptoms, able to carry out all usual duties and activities, 2: Slight disability, unable to carry out all previous activities but able to look after own affairs without assistance, 3: Moderate disability requiring some help, but able to walk without assistance, 4: Moderately severe disability, unable to walk without assistance and unable to attend to own bodily needs without assistance, 5: Severe disability, bedridden, incontinent and requiring constant nursing care and attention, 6: death prior to Day 90. Reported is the percentage of participants with scores of 0 or 1 on the mRS.|Day 90|Intent-to-Treat (ITT) population included all randomized participants.|||percentage of participants|||Number
2608916|NCT02072200|Secondary|Change of Functional Disability Index of the Korea Health Assessment Questionnaire (KHAQ) From Baseline to Week 12|Change in KHAQ score from baseline to Week 12 post-treatment: KHAQ is composed of 8 functional disability indices. The scale for each index is from 0 (without any difficulty) to 3 (unable to do). Scores for each disability index were summed to obtain the total score for each subject, ranging between 0 to 24, with higher scores reflecting higher functional disability. The scores were then averaged across all subjects.|12 weeks|ITT set was 145 patients, but 11 patients data was not assessed except baseline score.|||scores on a scale||Standard Deviation|Mean
2608917|NCT02072200|Secondary|Change of Baseline Severity of Morning Stiffness at Week 12 Using Visual Analog Scale (VAS) Scale|The VAS is a 100 mm line ranging from 0 mm (no pain) on the left end and 100 mm (worst pain) on the right end. Subjects marked on the line to indicate their pain severity. The distance in mm was measured from the left end to the subject's marking.|Baseline and 12 weeks|ITT population was 145, but 3 patients were not assessed for primary efficacy parameter of morning stiffness severity. So, Last Observation Carried Forward (LOCF) was not done for these 3 patients after baseline . Other patients' missing data were handled using LOCF method.|||mm||Standard Deviation|Mean
2608981|NCT02071290|Secondary|Ventilator Free Days|Secondary clinical outcomes|up to 28 days or discharge||||Days||Inter-Quartile Range|Median
2608918|NCT02072200|Primary|Change From Baseline in Morning Stiffness Duration at Week 12 as Assessed by Patient Diary|"Data for the duration of morning stiffness will be obtained from patient diaries. Duration of morning stiffness will be from wake-up time to time of resolution of morning stiffness.~Relative reduction rate of the morning stiffness duration from baseline to Week 12 of the study drug treatment was calculated for this outcome measure."|Baseline and 12 weeks|ITT set = 145 patients. Missing data was handled as LOCF.|||minutes||Standard Deviation|Mean
2608919|NCT02072174|Secondary|Percentage of Patients With Exacerbation of the Disease Course|The development of disease complications requiring antibiotics drugs or hospitalization|14 days of observation treatment|Per Protocol set|||Participants|||Count of Participants
2608920|NCT02072174|Secondary|Change in Viral Load During the Treatment and Follow-up Periods|Viral load is evaluated in subjects with positive influenza A and B tests. Virus load [log10 copies influenza А/В RNA per 1 mL] in nasal and pharyngeal swabs is determined using real-time PCR on days 1, 3, 5 and 7.|on days 1, 3, 5, 7 of observation treatment|Viral load is evaluated in subjects with positive influenza A and B tests.|||log10 copies influenza А/В RNA per 1 mL||Standard Deviation|Mean
2608921|NCT02072174|Secondary|Number of Intakes of Antipyretics|Number of Intakes of Antipyretics based on patient diary data|on days 1-5 of therapy|Per Protocol set|||Number of intakes||Standard Deviation|Mean
2608922|NCT02072174|Secondary|"Assessment of the Severity of Influenza Virus / Acute Respiratory Viral Infection Using the Area Under the Curve for an Overall Symptom Assessment"|"Total Symptom Score is based on the severity of each disease symptom. The TSS includes 13 symptoms: body temperature/fever, non-specific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), nasal/throat/chest symptoms (runny nose, nasal congestion, sneezing, sore throat, hoarseness, cough, chest pain/tightness of the chest).~Minimum score=0; maximum score=39. The area under the curve 1 = on days 1, 3, 5 and 7 on the results of doctor`s examination The area under the curve 2 = based on days 1-7 on the patient diary data"|on days 1-7 of observation (based on days 1-7 on the patient diary data; on days 1, 3, 5 and 7 of observation - according to physician's objective examination)|Per Protocol set|||score*day||Standard Deviation|Mean
2608923|NCT02072174|Secondary|Severity of Clinical Manifestations of Influenza / Acute Respiratory Viral Infection by Total Symptom Score.|"Total Symptom Score is based on the severity of each Influenza / Acute Respiratory Viral Infection symptom.~Total Symptom Score includes 13 symptoms: body temperature, non-specific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), nasal/throat/chest symptoms.~The severity of non-specific and nasal/throat/chest symptom is scored on a symptom severity scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms).~Minimum score=0; maximum score=39. The severity of symptoms is recorded by the doctors on the case record form on days 3, 5 and by parents/adopter on a diary card twice a day on days 2-6."|on days 2-6 of observation treatment|Per Protocol set|||score on a scale||Standard Deviation|Mean
2608924|NCT02072174|Secondary|Percentage of Patients With Normal Body Temperature (≤37.0ºС)|Based on the patient diary data. Axillary temperature (morning and evening) decline to or below 37.0 ºС.|on days 2, 3, 4 and 5 of observation treatment|Per Protocol set|||Participants|||Count of Participants
2608925|NCT02072174|Secondary|Changes in Body Temperature|Changes in Body Temperature Based on Patient Diary Data|baseline and days 2, 3, 4 and 5 of observation treatment|Per Protocol set|||°C||Standard Deviation|Mean
2608926|NCT02072174|Secondary|Percentage of Patients With Recovery/Improvement in Health|Based on Days 2, 3, 4 and 5 of observation treatment (according to the patient's diary), on days 3 and 5 of therapy (according to physician's objective examination).|on days 2, 3, 4 and 5 of the treatment|Per Protocol set|||Participants|||Count of Participants
2608927|NCT02072174|Primary|Average Illness Duration|"Disease duration is assessed until recovery or significant improvement. Average illness duration is defined as the interval between the start of the trial treatment and the start of the first 24-hour period in which the non-specific symptoms and nasal/ throat/ chest symptoms improve to absent or mild (Total Symptom Score of severity had decreased to ≤2 points) and body temperature returns to 37.2°C or below.~Based on patient diary data."|From the time of randomization until the time of recovery/improvement (days 1-14)|Per Protocol set|||days||Standard Deviation|Mean
2608928|NCT02072096|Other Pre-specified|Change From Baseline in Mini-mental State Examination (MMSE) Score||Baseline, Week 72|Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.||||||
2608929|NCT02072096|Other Pre-specified|Change From Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Score||Baseline, Week 72|Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.||||||
2608930|NCT02072096|Other Pre-specified|Change From Baseline in Adult Low Blood Sugar Survey (ALBSS) Score||Baseline, Week 72|Unable to conduct change from baseline analysis due to study closure and lack of endpoint data.||||||
2608931|NCT02072096|Secondary|Change From Baseline of Estimated Glomerular Filtration Rate (eGFR)|The eGFR is used in addition to the Urinary Albumin to Creatinine Ratio to measure the incidence and progression of diabetic kidney disease.|Baseline, Week 72|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline eGFR data.|||milliliter per minute/1.73 square meter||Standard Deviation|Mean
2608932|NCT02072096|Secondary|Change From Baseline in Body Mass Index (BMI)||Baseline, Week 72|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline BMI data.|||kilogram per square meter (kg/m^2)||Standard Deviation|Mean
2608933|NCT02072096|Secondary|Change From Baseline of Urinary Albumin to Creatinine Ratio|The Urinary Albumin to Creatinine Ratio is used in addition to Estimated Glomerular Filtration Rate (eGFR) to measure the incidence and progression of diabetic kidney disease.|Baseline, Week 72|All participants who received at least one dose of study drug and had evaluable baseline and post-baseline urinary albumin to creatinine ratio.|||milligram per millimole (mg/mmol)||Standard Deviation|Mean
2608934|NCT02072096|Secondary|Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia||Baseline to last participant visit (up to 72 weeks)|All participants who received at least one dose of study drug.|||Participants|||Number
2608935|NCT02072096|Secondary|Percentage of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy||Baseline to last participant visit (up to 72 weeks)|All participants who received at least one dose of study drug.|||percentage of participants|||Number
2608936|NCT02072096|Primary|Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia|Failed to reach and maintain HbA1c target, without clinically significant hypoglycemia, is defined as having 2 consecutive HbA1c > upper limit of HbA1c target over 12 weeks starting from Week 24 for participants with HbA1c data beyond Week 24, or Week 24 HbA1c > upper limit of HbA1c target for participants without HbA1c data beyond Week 24. Clinically significant hypoglycemia is defined as any severe hypoglycemia or repeated hypoglycemia interrupting participants activities or sleep and associated with blood glucose ≤3.9 millimole per liter (mmol/L), or repeated asymptomatic hypoglycemia associated with blood glucose <3.0 mmol/L. Success is defined as lacking of failure.|Baseline to last participant visit (up to 72 weeks)|All participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2608937|NCT02071914|Primary|Viral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR|AUC of Viral Load, as Measured by Quantitative PCR of Nasopharyngeal Swab, Post-viral Challenge to the Last Assessment Day in Quarantine|Three times a day from Day 1(the day after virus inoculation) to Day 9|The Infected Population included all subjects in the Efficacy Population who provided at least 2 positive nasopharyngeal swabs within 24 h when tested using quantitative PCR assay.|||Days*Eq log10 TCID50/mL||Standard Deviation|Mean
2608938|NCT02071849|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||l/min/m^2||Standard Deviation|Mean
2608939|NCT02071849|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||l/min/m^2||Standard Deviation|Mean
2608940|NCT02071849|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||l/min||Standard Deviation|Mean
2608941|NCT02071849|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||l/min||Standard Deviation|Mean
2608942|NCT02071849|Secondary|Left Ventricular Ejection Fraction (LVEF) - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||percentage of blood volume||Standard Deviation|Mean
2608943|NCT02071849|Secondary|Left Ventricular Ejection Fraction (LVEF) - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||percentage of blood volume||Standard Deviation|Mean
2608944|NCT02071849|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||ml||Standard Deviation|Mean
2608945|NCT02071849|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||ml||Standard Deviation|Mean
2608946|NCT02071849|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||ml||Standard Deviation|Mean
2608947|NCT02071849|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||ml||Standard Deviation|Mean
2608948|NCT02071849|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||cm||Standard Deviation|Mean
2608949|NCT02071849|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||cm||Standard Error|Mean
2608950|NCT02071849|Secondary|LVID Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||cm||Standard Deviation|Mean
2608951|NCT02071849|Secondary|Left Ventricular Internal Dimension (LVID) Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||cm||Standard Deviation|Mean
2608952|NCT02071849|Secondary|LV Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||g||Standard Deviation|Mean
2608953|NCT02071849|Secondary|Left Ventricular (LV) Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||g||Standard Deviation|Mean
2608954|NCT02071849|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||mm Hg||Standard Deviation|Mean
2608955|NCT02071849|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||mm Hg||Standard Deviation|Mean
2608956|NCT02071849|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||mm Hg||Standard Deviation|Mean
2608957|NCT02071849|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||mm Hg||Standard Deviation|Mean
2608959|NCT02071849|Secondary|New York Heart Association (NYHA) Functional Capacity Classification|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|6 months postprocedure|Participants with an evaluation of this measure.|||Participants|||Count of Participants
2608960|NCT02071849|Secondary|Aortic Insufficiency (AI) at 2 Years|Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure.|||Participants|||Count of Participants
2608961|NCT02071849|Secondary|Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure.||2 years||||percentage of participants||95% Confidence Interval|Number
2608962|NCT02071849|Secondary|Actuarial Freedom From Clinical Cardiovascular Events|Freedom from specified clinical cardiovascular events 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months|2 years postprocedure||||percentage of participants||95% Confidence Interval|Number
2608963|NCT02071849|Secondary|Actuarial Freedom From Clinical Cardiovascular Events|Freedom from specified clinical cardiovascular events 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months|6 months postprocedure||||percentage of participants||95% Confidence Interval|Number
2608964|NCT02071849|Secondary|Implant Procedure Success|Success is defined as the absence of specified adverse events evaluated through discharge following the procedure: - Aortic annular dissection, rupture, or leaflet damage - Mitral valve impingement due to implant - implant dehiscence/migration into aorta - implant dehiscence/migration into left ventricle - Hemodynamics requiring intervention - Other adverse event resulting in reoperation, explantation, or permanent disability.|discharge or 14 days postprocedure, whichever comes first||||percentage of participants||95% Confidence Interval|Number
2608965|NCT02071849|Primary|Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months|Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderately Severe (3+), or Severe (4+)|6 months postprocedure|Participants with an echocardiogram evaluable for this measure.|||Participants|||Count of Participants
2608966|NCT02071849|Primary|Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure.||6 months postprocedure||||percentage of participants||95% Confidence Interval|Number
2608967|NCT02071823|Primary|Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞)|Area Under the Concentration-time Curve Extrapolated to Infinity (AUC∞) for BIA 9-1067|Day 1||||ng·h/mL||Standard Deviation|Mean
2608968|NCT02071823|Primary|AUCt - Cumulative Area Under the Plasma Concentration Time Curve|AUCt - Cumulative Area Under the plasma concentration time Curve for BIA 9-1067|Day 1||||ng·h/mL||Standard Deviation|Mean
2608969|NCT02071823|Primary|Cmax - Maximum Observed Plasma Concentration|Cmax - Maximum observed plasma concentration of BIA 9-1067|Day 1||||ng/mL||Standard Deviation|Mean
2608970|NCT02071810|Primary|Number of Patients With at Least One Adverse Event||participants will be followed for the duration of hospital stay, an expected average of 6 weeks||||Number of patients|||Number
2608971|NCT02071771|Secondary|Lens Oscillation at Blink at Day 10|Lens oscillation (rotational stability of the lens on the eye) at blink was video-recorded. Digital images were used to measure the rotational characteristics of the lenses and objectively measure the amplitude of the lens oscillation. A higher value indicates greater lens movement on the eye. This outcome measure was collected at one site only.|Day 10, each product|This analysis group includes all randomized subjects at the UK site with data at visit who had no major protocol violations excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan.|||degrees||Standard Deviation|Mean
2608972|NCT02071771|Primary|High Contrast Time Controlled Visual Acuity (TCVA) at Day 10|TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.|Day 10, each product|This analysis group includes all randomized subjects who had no major protocol violations excluding those who met the critical deviation criteria as specified in the Deviations and Evaluability Plan.|||VA units||Standard Deviation|Mean
2608973|NCT02071706|Primary|Number of Diagnostic Quality Images|Number of images sets deemed diagnostic quality by the investigator|1 day|PET/MR Scans with qualitative comments|||Image sets|Number of Image Sets||Number
2608974|NCT02071706|Primary|Number Usable PET/MRI Image Sets|The number PET/MRI image sets determined usable by a radiologist on a yes/no binary scale|1 day||||Usable image sets|||Number
2608975|NCT02071420|Primary|Change in Occupational Physical Activity From Baseline to 16 Weeks|Occupational physical activity (primary outcome) will be measured objectively with the GENEActiv physical activity monitor. The monitor will be worn on the right ankle and will be worn for 5 working days during all non-bathing hours. The outcome measure will be change in occupational activity (average counts/work day) from baseline to 16 weeks. The measure will be calculated as follows: 16 weeks value - baseline value.|Baseline and 16 weeks||||Average counts/work day||95% Confidence Interval|Mean
2608976|NCT02071290|Secondary|28 Day Mortality|Secondary clinical outcomes|up to 28 days or discharge||||Participants|||Count of Participants
2608977|NCT02071290|Secondary|24 Hour Mortality|Secondary clinical outcomes|up to 28 days or discharge||||Participants|||Count of Participants
2608978|NCT02071290|Secondary|Nosocomial Infections|Secondary clinical outcomes|up to 28 days or discharge||||Participants|||Count of Participants
2608979|NCT02071290|Secondary|Hospital Free Days|Secondary clinical outcomes|up to 28 days or discharge||||Days||Inter-Quartile Range|Median
2608980|NCT02071290|Secondary|ICU Free Days|Secondary clinical outcomes|up to 28 days or discharge||||Days||Inter-Quartile Range|Median
2608998|NCT02071290|Primary|Neutrophil Adhesion Molecule Expression (CD11b)|Change in neutrophil adhesion molecule (CD11b) expression over 24 hours from admission. Measured by flow cytometry using whole blood samples.|0 (Admission), 1, 3, 24 hours after intervention||||Median Fluorescence Intensity||Inter-Quartile Range|Median
2608999|NCT02071290|Primary|Neutrophil Oxidative Burst Activity (PMA Stimulated)|Change in PMA stimulated neutrophil oxidative burst activity (dihydrorhodamine, DHR) over 24 hours. Measured by flow cytometry using whole blood samples.|0 (Admission), 1, 3, 24 hours after intervention||||Median Fluorescence Intensity||Inter-Quartile Range|Median
2609000|NCT02071290|Primary|Neutrophil Oxidative Burst Activity|Change in neutrophil oxidative burst activity (dihydrorhodamine, DHR) over 24 hours from admission. Measured by flow cytometry using whole blood samples.|0 (Admission), 1, 3, 24 hours after intervention||||Median Fluorescence Intensity||Inter-Quartile Range|Median
2609001|NCT02071225|Secondary|Percentage of Participants With Concomitant Medication|Concomitant therapies included any medication (prescription medication, over-the-counter medications, herbal/homeopathic remedies, nutritional supplements) used by subjects in the 7 days prior to screening until the end of treatment. The following treatments were not permitted during the study treatment period: investigational or unauthorized or unapproved medicinal products, immunotherapy or radioimmunotherapy (other than the trial immunotherapy, obinutuzumab), chemotherapy (other than the trial chemotherapy, bendamustine) and radiotherapy.|From 7 days prior to screening to the end of treatment at 6 months|Safety population included all participants, who received at least one dose of any treatment.|||percentage of participants|||Number
2609002|NCT02071225|Secondary|Percentage of Participants With Previous/Concomitant Diseases||Up to approximately 4.5 years|Safety population included all participants, who received at least one dose of any treatment.|||percentage of participants|||Number
2609003|NCT02071225|Secondary|Percentage of Participants Who Discontinued Treatment Prematurely||Up to end of treatment at 6 months|Safety population included all participants, who received at least one dose of any treatment.|||percentage of participants|||Number
2609004|NCT02071225|Secondary|Percentage of Participants With Infusion-related Reactions (IRRs)|IRRs were defined as AEs occurring during or within 24 hours following the administration of an infusion and considered related to drug treatment.|Up to end of treatment at 6 months|Safety population included all participants, who received at least one dose of any treatment.|||percentage of participants|||Number
2609005|NCT02071225|Secondary|Percentage of Participants With AEs of Special Interest (AESIs)|AESIs included any of the following: SAEs associated with the infusion of obinutuzumab: obinutuzumab serious infusion-related reactions, which were defined as AEs occurring during or within 24 hours following the administration of an infusion of obinutuzumab and considered related to obinutuzumab; serious infection; serious neutropenia; any tumor lysis syndrome (TLS); second malignancies.|Up to approximately 4.5 years|Safety population included all participants, who received at least one dose of any treatment.|||percentage of participants|||Number
2609006|NCT02071225|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. An SAE was any AE that was any of the following: fatal, life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, and was considered a significant medical event by the investigator.|Up to approximately 4.5 years|Safety population included all participants, who received at least one dose of any treatment.|||percentage of participants|||Number
2609007|NCT02071225|Secondary|Percentage of Participants With Minimal Residual Disease (MRD) Negativity|MRD negativity was defined as the presence of less than 1 cell of CLL per 10,000 leukocytes (= category 0, <0.01%) assessed in bone marrow (BM) and peripheral blood (PB) by flow cytometry after the end of the treatment at the final response assessment.|At approximately 9 months|ITT population included all participants, who received at least one dose of any treatment.|||percentage of participants|||Number
2609008|NCT02071225|Secondary|Time to Re-treatment/New Anti-leukemia Therapy|Time to re-treatment/new leukemia therapy was defined as the time between the start of treatment and the date of the first administration of re-treatment or new leukemia therapy.|Up to 4.5 years|Efficacy population included all participants, who received at least one dose of both treatments (bendamustine and obinutuzumab).|||months||95% Confidence Interval|Median
2609009|NCT02071225|Secondary|Duration of Response (DR)|DR was defined for participants with CRi, CR or PR. DR spanned from the date on which response was recorded until the date on which DP or death from any cause occurred. DP: at least one of the following characteristics: increase ≥ 50% in lymphocytes up to at least 5 x 10^9/L, appearance of new palpable lymph nodes, increase ≥ 50% of the longest diameter of any previous area of clinically significant lymphadenopathy, increase ≥ 50% of the size of the liver and/or spleen, transformation to a more aggressive histology, after treatment, progression of any cytopenia: decrease of hemoglobin levels of more than 20 g/L or to below 100 g/L and/or decrease of platelet counts by more than 50% or to below 100 x 10^9/L and/or decrease in the neutrophil counts by more than 50% or to below 1.0 x 10^9/L if the marrow biopsy also shows infiltration of clonal CLL cells.|From occurrence of CR or PR up to disease progression or death, whichever occurred first (up to approximately 4.5 years)|Efficacy population included all participants, who received at least one dose of both treatments (bendamustine and obinutuzumab). Included in the analysis are participants who achieved CRi, CR or PR.|||months||95% Confidence Interval|Median
2609017|NCT02071108|Secondary|Rutherford Clinical Category|Change in Rutherford Clinical Category (RCC) at 6 months. RCC identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Grade I includes Category 0 - Asymptomatic, Category 1 - Mild claudication, Category 2 - Moderate claudication, and Category 3 - Severe claudication. Grade II includes Category 4 - Ischemic rest pain and Category 5 - Minor tissue loss. Grade III includes Category 6 - Ulceration or grangrene. Change of at least 2 categories considered statistically significant.|Baseline and 6 months|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed|||Rutherford Clinical Category||95% Confidence Interval|Mean
2609010|NCT02071225|Secondary|Disease Free Survival (DFS)|DFS was defined for all participants who achieved complete response (CRi or CR). DFS lasted from the date on which CRi or CR was recorded until the date on which the first DP or death from any cause occurred. DP: at least one of the following characteristics: increase ≥ 50% in lymphocytes up to at least 5 x 10^9/L, appearance of new palpable lymph nodes, increase ≥ 50% of the longest diameter of any previous area of clinically significant lymphadenopathy, increase ≥ 50% of the size of the liver and/or spleen, transformation to a more aggressive histology, after treatment, progression of any cytopenia: decrease of hemoglobin levels of more than 20 g/L or to below 100 g/L and/or decrease of platelet counts by more than 50% or to below 100 x 10^9/L and/or decrease in the neutrophil counts by more than 50% or to below 1.0 x 10^9/L if the marrow biopsy also shows infiltration of clonal CLL cells.|From occurrence of complete response up to disease progression or death, whichever occurred first (up to approximately 4.5 years)|Efficacy population included all participants, who received at least one dose of both treatments (bendamustine and obinutuzumab). Included in the analysis are participants who achieved CRi or CR.|||months||95% Confidence Interval|Median
2609011|NCT02071225|Secondary|Event Free Survival (EFS)|EFS was defined as the time from the start of treatment to DP/relapse, death from any cause or start of a new anti-leukemia therapy. DP: at least one of the following characteristics: increase ≥ 50% in lymphocytes up to at least 5 x 10^9/L, appearance of new palpable lymph nodes, increase ≥ 50% of the longest diameter of any previous area of clinically significant lymphadenopathy, increase ≥ 50% of the size of the liver and/or spleen, transformation to a more aggressive histology, after treatment, progression of any cytopenia: decrease of hemoglobin levels of more than 20 g/L or to below 100 g/L and/or decrease of platelet counts by more than 50% or to below 100 x 10^9/L and/or decrease in the neutrophil counts by more than 50% or to below 1.0 x 10^9/L if the marrow biopsy also shows infiltration of clonal CLL cells.|From start of treatment up to disease progression or relapse or death or start of a new anti-leukemic therapy, whichever occurred first (up to approximately 4.5 years)|Efficacy population included all participants, who received at least one dose of both treatments (bendamustine and obinutuzumab).|||months||95% Confidence Interval|Median
2609012|NCT02071225|Secondary|Overall Survival (OS)|OS was defined as the time from the start of study treatment to death from any cause.|From start of treatment up to death of any cause (up to approximately 4.5 years)|Efficacy population included all participants, who received at least one dose of both treatments (bendamustine and obinutuzumab).|||months||95% Confidence Interval|Median
2609013|NCT02071225|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from the start of treatment to disease progression (DP), relapse or death from any cause, whichever occurs first, as assessed by the investigator. DP: at least one of the following characteristics: increase ≥ 50% in lymphocytes up to at least 5 x 10^9/L, appearance of new palpable lymph nodes, increase ≥ 50% of the longest diameter of any previous area of clinically significant lymphadenopathy, increase ≥ 50% of the size of the liver and/or spleen, transformation to a more aggressive histology, after treatment progression of any cytopenia: decrease of hemoglobin levels of more than 20 g/L or to below 100 g/L and/or decrease of platelet counts by more than 50% or to below 100 x 10^9/L and/or decrease in the neutrophil counts by more than 50% or to below 1.0 x 10^9/L if the marrow biopsy also shows infiltration of clonal chronic lymphocytic leukemia (CLL) cells.|From start of treatment up to disease progression or relapse or death, whichever occurred first (up to approximately 4.5 years)|Efficacy population included all participants, who received at least one dose of both treatments (bendamustine and obinutuzumab).|||months||95% Confidence Interval|Median
2609014|NCT02071225|Secondary|Best Response Rate as Assessed by the Investigator Using the IWCLL 2008 Criteria|Best overall response was defined as percentage of participants achieving a best response of CR, CRi and PR. CR: lymphocytes below 4 x 10^9/L, absence of lymphadenopathy, hepatomegaly and splenomegaly, absence of disease or constitutional symptoms, neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 110 g/L, bone marrow at least normocellular for age. CRi: CR with persistent cytopenia, i.e. anemia, thrombocytopenia and/or neutropenia. PR: reduction ≥ 50% of the lymphocyte count AND reduction ≥ 50% of the lymphadenopathy OR reduction ≥ 50% of the size of the liver if enlarged at baseline OR reduction ≥ 50% of the size of the spleen if enlarged at baseline PLUS one of the following: neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 110 g/L or increase ≥ 50% compared to pre-treatment.|During study treatment and until 6 months after end of study treatment at approximately 12 months|Efficacy population included all participants, who received at least one dose of both treatments (bendamustine and obinutuzumab). Reported here is the number of participants for whom data for best response achieved were available.|||percentage of participants|||Number
2609015|NCT02071225|Primary|Overall Response Rate (ORR) as Assessed by the Investigator Using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria|ORR was defined as percentage of participants achieving Complete Response (CR), incomplete CR (CRi) or Partial Response (PR). CR: lymphocytes below 4 x 10^9/L, absence of lymphadenopathy, hepatomegaly and splenomegaly, absence of disease or constitutional symptoms, neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 110 g/L, bone marrow at least normocellular for age. CRi: CR with persistent cytopenia, i.e. anemia, thrombocytopenia and/or neutropenia. PR: reduction ≥ 50% of the lymphocyte count AND reduction ≥ 50% of the lymphadenopathy OR reduction ≥ 50% of the size of the liver if enlarged at baseline OR reduction ≥ 50% of the size of the spleen if enlarged at baseline PLUS one of the following: neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 110 g/L or increase ≥ 50% compared to pre-treatment.|2-3 months after last dose of the study treatment (up to approximately 9 months)|Efficacy population included all participants, who received at least one dose of both treatments (bendamustine and obinutuzumab).|||percentage of participants||95% Confidence Interval|Number
2609016|NCT02071108|Other Pre-specified|Exploratory Endpoint|The clinical protocol provided for an Exploratory Secondary Endpoint to assess the ability of the device to achieve ≤30% residual stenosis without adjunctive PTA as assessed by the investigator via visual estimate.|Day of Procedure|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed|||percentage of lesions|lesions||Number
2609032|NCT02071095|Secondary|Percent Change in CD4+ Tcell-associated HIV-1 RNA as Compared to Baseline|CD4+ Tcell-associated HIV-1 RNA to determine whether Poly-ICLC disrupts viral latency in HIV-1-infected individuals on anti-retroviral therapy.Viral transcription assessed by monitoring cell associated HIV-1 RNA. Percent change compared to baseline.|Baseline, Day 2, Day 4, Day 8, Day 28||||percent change||Standard Deviation|Mean
2609018|NCT02071108|Secondary|Ankle Brachial Index (ABI)|Change in Ankle Brachial Index (ABI) of the target limb at 6 months. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm.|Baseline and 6 months|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Lithoplasty treatment was successfully completed|||Ankle Brachial Index||95% Confidence Interval|Mean
2609019|NCT02071108|Secondary|Patency|Vessel patency at 6 months at Doppler Ultrasound defined as freedom from greater than 50% restenosis (as assessed by Duplex ultrasound peak systolic velocity ratio of =2.5).|6 months|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed|||percentage of lesions|lesions|95% Confidence Interval|Number
2609020|NCT02071108|Secondary|Freedom From Target Lesion Revascularization (TLR)|Freedom from Target Lesion Revascularization (TLR) at 6 months|6 months|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed|||percentage of lesions|lesions||Number
2609021|NCT02071108|Secondary|Freedom From Major Adverse Events|Freedom from Major Adverse Events at 6 months|6 months|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted|||percentage of participants|||Number
2609022|NCT02071108|Secondary|Rutherford Clinical Category|Change in Rutherford Clinical Category (RCC) at 30 days. RCC identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Grade I includes Category 0 - Asymptomatic, Category 1 - Mild claudication, Category 2 - Moderate claudication, and Category 3 - Severe claudication. Grade II includes Category 4 - Ischemic rest pain and Category 5 - Minor tissue loss. Grade III includes Category 6 - Ulceration or grangrene. Change of at least 2 categories considered statistically significant.|Baseline and 30 days|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed|||change in RCC from baseline||95% Confidence Interval|Mean
2609023|NCT02071108|Secondary|Ankle Brachial Index (ABI)|Change in Ankle Brachial Index (ABI) of the target limb at 30 days. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm.|Baseline and 30 days|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed. Four subjects were not included in the analysis because ABI could not be measured due to non-compressible disease that inhibited accurate ABI measurement.|||change in ABI score from baseline||95% Confidence Interval|Mean
2609024|NCT02071108|Secondary|Patency|Vessel patency at 30 days by Doppler Ultrasound defined as freedom from greater than 50% restenosis (as assessed by Duplex ultrasound peak systolic velocity ratio of ≥2.5).|30 days|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted. Due to device malfunctions, one subject received partial treatment. To provide a more accurate account of actual device usage, the subject was omitted from the analysis of device usage only.|||percentage of lesions|lesions|95% Confidence Interval|Number
2609025|NCT02071108|Secondary|Freedom From Target Lesion Revascularization (TLR)|Freedom from Target Lesion Revascularization (TLR) at 30 days|30 days|Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed|||percentage of lesions|lesions||Number
2609026|NCT02071108|Secondary|Freedom From Major Adverse Events|Freedom from Major Adverse Events at 30 days.|30 days|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted|||percentage of participants|||Number
2609027|NCT02071108|Secondary|Technical Success:|The ability of the Shockwave Medical Lithoplasty System to delivery ShockWave treatment to the desired location in the target vessel. Up to two Shockwave Medical Lithoplasty Systems maybe used to complete treatment in the target vessel.|Day of Procedure|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted|||percentage of lesions|lesions|95% Confidence Interval|Number
2609028|NCT02071108|Secondary|Clinical Success:|The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive percutaneous transluminal angioplasty therapy) as assessed by the investigator via visual estimate and freedom from procedural major adverse events.|Day of Procedure|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted|||percentage of participants||95% Confidence Interval|Number
2609029|NCT02071108|Secondary|Device Success|The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (without adjunctive percutaneous transluminal angioplasty therapy) as assessed via quantitative angiography via core lab evaluation.|Day of Procedure|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment attempted|||percentage of lesions|lesions|95% Confidence Interval|Number
2609030|NCT02071108|Primary|Procedural Success:|The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive Percutaneous Transluminal Angioplasty therapy) as assessed by quantitative angiography via core lab evaluation.|Day of Procedure|Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted.|||percentage of lesions|lesions|95% Confidence Interval|Number
2609031|NCT02071108|Primary|Composite of New-onset Major Adverse Events (MAE)|Need for emergency surgical revascularization of target limb. Unplanned target limb amputation (above the ankle). Symptomatic thrombus or distal emboli, defined as clinical signs or symptoms of thrombus or distal emboli detected in the treated limb in the area of the treated lesion, or distal to the treated lesion, after the index procedure or noted angiographically, and requiring mechanical or pharmacologic means to improve flow. Perforations and dissections of grade D or greater that require an intervention to resolve, including bail-out stenting.|30 days||||participants|||Number
2609037|NCT02071082|Secondary|Change From Baseline in FibroTest® Score at Week 48|The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.|Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2609038|NCT02071082|Secondary|Change From Baseline in FibroTest® Score at Week 24|The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Inter-Quartile Range|Median
2609039|NCT02071082|Secondary|Percentage of Participants With Seroconversion to Anti-HBe at Week 48|Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.|Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.|||percentage of participants|||Number
2609040|NCT02071082|Secondary|Percentage of Participants With Seroconversion to Hepatitis B e Antibody (Anti-HBe) at Week 24|Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.|||percentage of participants|||Number
2609041|NCT02071082|Secondary|Percentage of Participants With Seroconversion to Anti-HBs at Week 48|Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.|Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.|||percentage of participants|||Number
2609042|NCT02071082|Secondary|Percentage of Participants With Seroconversion to Hepatitis B Surface Antibody (Anti-HBs) at Week 24|Seroconversion to antibody is defined as (1) antigen loss and (2) positive postbaseline antibody value. Missing = excluded method.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed who had positive antigen and negative antibody at baseline.|||percentage of participants|||Number
2609043|NCT02071082|Secondary|Percentage of Participants With Normalized ALT at Week 48|ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.|Baseline; Week 48|Participants in the Full Analysis Set who had ALT values above the normal range at baseline were analyzed.|||percentage of participants|||Number
2609044|NCT02071082|Secondary|Percentage of Participants With Normalized Alanine Aminotransferase (ALT) at Week 24|ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.|Baseline; Week 24|Participants in the Full Analysis Set who had ALT values above the normal range at baseline were analyzed.|||percentage of participants|||Number
2609045|NCT02071082|Secondary|Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL|The percentage of participants with HBV DNA < 29 IU/mL at Week 48 was calculated using the missing = failure method.|Week 48|Full Analysis Set|||percentage of participants|||Number
2609046|NCT02071082|Secondary|Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set|||percentage of participants|||Number
2609047|NCT02071082|Primary|Percentage of Participants With Plasma HBV DNA Levels < 29 IU/mL|The percentage of participants with HBV DNA < 29 IU/mL at Week 24 was calculated using the missing = failure method.|Week 24|Full Analysis set|||percentage of participants|||Number
2609048|NCT02071082|Primary|Percentage of Participants With Plasma HIV-1 RNA Level < 50 Copies/mL|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: participants who were enrolled, received at least 1 dose of study drug, had at least 1 post-Day 1 plasma HBV DNA or HIV-1 RNA result while on study, and had no major protocol violations from the eligibility criteria.|||percentage of participants|||Number
2609049|NCT02070991|Secondary|Change From Baseline to Week 12 in Diastolic Pulmonary Vascular Pressure Gradient (DPG)||From randomization up to end of treatment period (Week 12)|The values of 11 patients in the macitentan group and of 8 patients in the placebo group are missing.|||mmHg||95% Confidence Interval|Mean
2609050|NCT02070991|Secondary|Change From Baseline to Week 12 in Cardiac Index (CI)||From randomization up to end of treatment period (Week 12)|The values of 11 patients in the macitentan group and of 8 patients in the placebo group are missing.|||L/min/m^2||95% Confidence Interval|Mean
2609051|NCT02070991|Secondary|Change From Baseline to Week 12 in Pulmonary Artery Wedge Pressure (PAWP)||From randomization up to end of treatment period (Week 12)|The values of 11 patients in the macitentan group and of 8 patients in the placebo group are missing.|||mmHg||95% Confidence Interval|Mean
2609052|NCT02070991|Secondary|Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP)||From randomization up to end of treatment period (Week 12)|The values of 10 patients in the macitentan group and of 7 patients in the placebo group are missing.|||mmHg||95% Confidence Interval|Mean
2609053|NCT02070991|Secondary|Change From Baseline to Week 12 in Mean Pulmonary Arterial Pressure (mPAP)||From randomization up to end of treatment period (Week 12)|The values of 10 patients in the macitentan group and of 7 patients in the placebo group are missing.|||mmHg||95% Confidence Interval|Mean
2609054|NCT02070991|Secondary|PVR at Rest at Week 12 Expressed as Percent of Baseline PVR at Rest|Pulmonary vascular resistance (PVR) was assessed at rest by right heart catheterization (RHC).|From randomization up to end of treatment period (Week 12)|The values of 11 patients in the macitentan group and of 8 patients in the placebo group are missing.|||percentage of baseline PVR||95% Confidence Interval|Geometric Mean
2609055|NCT02070991|Secondary|NT-proBNP at Week 12 Expressed as Percent of Baseline NT-proBNP at Rest||From randomization up to end of treatment period (Week 12)|The values of 6 patients are missing in both the macitentan and the placebo group.|||percentage of baseline NT-proBNP||95% Confidence Interval|Geometric Mean
2609056|NCT02070991|Primary|Number of Participants Experiencing Significant Fluid Retention or Worsening in NYHA Functional Class (FC) up to End-of-treatment|The main endpoint is the number of participants who had at least one of the following: A) significant fluid retention, defined as increase in body weight at any time by ≥ 5% or ≥ 5 kg from baseline due to fluid overload and/or parenteral administration of diuretics. B) Worsening of NYHA functional class from baseline.|From randomization up to End-of-Study (Week 12 + 30 days follow-up) plus 1 calendar day||||Participants|||Count of Participants
2609057|NCT02070978|Secondary|Number of Participants With Columbia-Suicide Severity Rating Scale (C-SSRS) Score|"The C-SSRS assesses the suicidal behavior and suicidal ideation in participants. Occurrence of suicidal behavior after study entry is defined as having answered yes to a least 1 of the 4 suicidal behavior subcategories (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). Occurrence of suicidal ideation is defined as having answered yes to at least 1 of the suicidal ideation sub-categories (1) wish to be dead, (2) nonspecific active suicidal thoughts, (3) active suicidal ideation with any methods (no plan) without intent to act, (4) active suicidal ideation with some intent to act (without specific plan), and (5) active suicidal ideation with specific plan and intent)."|LTE Day 1, Week 24, Week 48, Week 72 and Week 98|The safety analyses set included all participants enrolled into the LTE study and who received at least 1 dose of planned study treatment. Participants were analyzed according to the actual treatment they received.|||Participants|||Count of Participants
2609058|NCT02070978|Secondary|Number of Participants With at Least One Adverse Event|An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. Treatment-Emergent adverse events (TEAEs) are defined as events with an onset date on or after the date of first dose of study treatment in the core study and ongoing at LTE study entry, or occurring during LTE study.|Baseline (Day 1 of Core study) up to maximum duration of 167.7 weeks|The safety analyses set included all participants enrolled into the LTE study and who received at least 1 dose of planned study treatment. Participants were analyzed according to the actual treatment they received.|||Participants|||Count of Participants
2609059|NCT02070978|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score|The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. It uses a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse possible score) to 52 (best score). A higher score reflected an improvement in the participant's health status.|Baseline: Day 1 (Core study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96|"mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories."|||Units on a scale||Standard Deviation|Mean
2609060|NCT02070978|Secondary|Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores|EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline defined as Day 1 of core study.|Baseline: Day 1 (Core Study), LTE Day 1, Week 24, Week 48, Week 72 and Week 96|"mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories."|||mm||Standard Deviation|Mean
2609061|NCT02070978|Secondary|Change From Baseline in EuroQoL 5 Dimension Instrument (EQ-5D) Score|EQ-5D questionnaire comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on 3 levels; 1=no problem, 2=moderate problems, 3=extreme problems. This part, called the EQ-5D descriptive system, provides a 5-dimensional description of health status. 5 dimensional 3-level system was converted into single index utility score. Possible values for single index utility score ranged from -0.594 (severe problems in all dimensions) to 1.0 (no problem in all dimensions) on scale where 1 represented best possible health state. Baseline was defined as Day 1 of Core study.|Baseline: Day 1 (Core Study), LTE Day 1, Week 24, Week 48, Week 72 and Week 96|"mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories."|||Units on a scale||Standard Deviation|Mean
2609062|NCT02070978|Secondary|Number of Participants With Patient Global Impression of Change (PGIC)|The PGIC is self-rated scale that asks the participant to describe the change in activity limitations, symptoms, emotions, and overall Quality of life (QoL) related to the participant's painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Number of participants in the PGIC categories of very much improved (1) and much improved (2) are reported.|Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72 and Week 96|"mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories."|||Participants|||Count of Participants
2609063|NCT02070978|Secondary|Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score|The LupusQoL was a lupus-specific health related QoL (HRQoL) questionnaire consisting of 34 items grouped in 8 domains: physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. Participants indicate their responses on a 5-point Likert response format, where 4 = never, 3 = occasionally, 2 = a good bit of the time, 1 = most of the time, and 0 = all of the time. Summary scores can be calculated for all 8 domains. A LupusQoL score for each domain was reported on a 0 to 100 scale, with greater values indicating better HRQoL. Baseline was defined as Day 1 of core study.|Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72, and Week 96|"mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories."|||Units on a scale||Standard Deviation|Mean
2609064|NCT02070978|Secondary|Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score|The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being. These eight subscales were summarized as relating to either physical health or mental health. Physical component summary (PCS) is based primarily on physical functioning, role-physical, bodily pain, and general health scales and mental component summary (MCS) encompasses vitality, social functioning, role-emotional, and mental health scales. Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning).|Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72 and Week 96|"mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories."|||Units on a scale||Standard Deviation|Mean
2609065|NCT02070978|Secondary|Percent Change From Baseline in Prednisone-equivalent Corticosteroid Dose||Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96|"mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories."|||Percent change||Standard Deviation|Mean
2609066|NCT02070978|Secondary|Number of Participants Who Achieved BILAG-based Combined Lupus Assessment (BICLA) Response (a Disease Activity Composite Index)|The BICLA response was defined as BILAG-2004 improvement (all screening visit BILAG A improving to B/C/D, all screening visit BILAG B to C/D, and less than or equal to (<=1) new BILAG B and no new BILAG A); no deterioration in SLEDAI total score; PGA increase by less than (<) 0 percentage (%) (defined as less then (<)0.3 point increase for the statistical analyses) and no non-permitted medication/treatment. Baseline was defined as core study screening visit.|Baseline: Core study Screening; LTE Day 1, Week 24, Week 48, Week 72 and Week 96|"mITT BILAG analysis set included mITT population with at least one BILAG A and/or B at screening visit. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories."|||Participants|||Count of Participants
2609067|NCT02070978|Secondary|Number of Participants Who Achieved SLE Responder Index (SRI-4) Response (a Disease Activity Composite Index)|SRI-4 response was defined as greater than or equal to 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A and no more than 1 new BILAG B domain score and no worsening (less than 10 percent increase) from baseline Physician's Global Assessment of Disease Activity (PGA). SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).|Baseline: Core study Screening; LTE Day 1, Week 24, Week 48, Week 72 and Week 96|"mITT analysis set was used. For this outcome measure, baseline was measured as reference timepoint for response in the screening visit from core study. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories."|||Participants|||Count of Participants
2609068|NCT02070978|Secondary|Change From Baseline in Disease Activity as Measured by Physician's Global Assessment (PGA) Score|The PGA was used to quantify disease activity and was measured using an anchored visual analog scale (VAS). The participant's current disease activity assessed by investigator in the score range of 0 to 3. Where 0=none; 1=mild; 2=moderate; 3=severe. The assessment made relative not to the participant's most severe state, but the most severe state of systemic lupus erythematosus (SLE) per the investigator's assessment. Baseline was defined as core study screening visit.|Baseline: Screening Visit (Core Study); LTE Day1, Week 24, Week 48, Week 72 and Week 96|"mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories."|||Units on a scale||Standard Deviation|Mean
2609069|NCT02070978|Secondary|Change From Baseline in Disease Activity as Measured by SLEDAI-2K Responder Index-50 (SRI-50) Score|SRI-50 index was derived from SLEDAI-2K and could capture 50% or better improvement in each descriptor between any 2 visits in systemic lupus erythematosus (SLE) participants when there was incomplete resolution. The new assigned scores for the descriptors of SRI-50 were derived by dividing the score of each SLEDAI-2K descriptor by 2. SLEDAI-2K was an activity index that measured disease activity and records feature of active lupus as present or not present. SLEDAI-2K used a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms. Each symptom present was assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranged from 0 points (no symptoms) to 105 points (presence of all defined symptoms).|Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96|Data was not collected for this endpoint as the results from ADDRESS II core study (700461-023; NCT01972568) for SRI-50 were not significant. Therefore, data collection for the SRI-50 for current study (700461-024; NCT02070978) was halted and no analysis was conducted for endpoint.||||||
2609070|NCT02070978|Secondary|Change From Baseline in Disease Activity as Measured by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score|SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms). Baseline was defined as core study screening visit.|Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96|"mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here, Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories."|||Units on a scale||Standard Deviation|Mean
2609071|NCT02070978|Secondary|Change From Baseline in Disease Activity as Measured by British Isles Lupus Assessment Group (BILAG) 2004 Score|BILAG Disease Activity Index evaluates systemic lupus erythematosus (SLE) activity in 8 organ system domains: General, mucocutaneous, neurological, musculoskeletal, cardiorespiratory, vasculitis, renal, and hematologic using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Severe disease activity; BILAG B: moderate disease activity; BILAG C: mild disease; BILAG D: system previously affected but now inactive; BILAG E: system never involved. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). The total BILAG score is the sum of the scores of the 8 domains where A=9, B=3, C=1, D=0, and E=0. The total score ranges from 0 to 72 with a higher score indicating greater lupus activity.|Baseline: Core study Screening, LTE Day 1, Week 24, Week 48, Week 72 and Week 96|"mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories."|||Units on a scale||Standard Deviation|Mean
2609072|NCT02070978|Secondary|Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Organ Damage Scores|SLICC/ACR score or damage index evaluates cumulative damage in Systemic Lupus Erythematosus (SLE). These changes may or may not be related to SLE. Most items are scored only if they have been present for at least 6 months. Scores range from 0 to 47 points, with higher scores indicating greater cumulative damage. Baseline was defined as Day 1 of Core study.|Baseline: Day 1 (Core Study), Day 1 (LTE Study), Week 24, Week 48, Week 72 and Week 96|"Modified intent-to-treat (mITT) analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories."|||Units on a scale||Standard Deviation|Mean
2609073|NCT02070978|Primary|Number of Participants Who Prematurely Discontinued the Treatment Due to Adverse Event (AE)|An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. TEAEs were defined as events with an onset date on or after the date of first dose of study treatment in the core study and ongoing at the 024 LTE study entry, occurring during the 024 LTE study and the Safety follow-up Period.|Baseline (Day 1 of Core study) up to maximum duration of 167.7 weeks|The safety analyses set included all participants enrolled into the LTE study and who received at least 1 dose of planned study treatment. Participants were analyzed according to the actual treatment they received.|||Participants|||Count of Participants
2609074|NCT02070978|Primary|Number of Participants With at Least One Serious Adverse Event (SAE) During the Treatment Period|An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. An AE was considered as 'treatment emergent' if it occurred after the first drug administration of each period or if it was present prior to drug administration but exacerbated after the drug administration. Treatment- Emergent adverse events (TEAEs) during the treatment period exclude those ongoing at the time of study entry into 024 LTE Day 1 and exclude the safety follow-up period.|Baseline (LTE Day 1) up to maximum treatment duration of 143.7 weeks|The safety analyses set included all participants enrolled into the LTE study and who received at least 1 dose of planned study treatment. Participants were analyzed according to the actual treatment they received.|||Participants|||Count of Participants
2609075|NCT02070965|Primary|The Number of Subjects With HPA Axis Suppression||Day 15|Three subjects in the 28 day DFD01 Treatment Group, three subjects in the 14 day Comp01 Treatment Group, and one subject in the 14 day DFD01 Treatment Group did not have ACTH stimulation test results.|||Participants|||Count of Participants
2609076|NCT02070757|Secondary|Percentage of Participants Discontinuing Study Drug Due to an Adverse Event (AE)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Up to 14 days after the first dose of study drug (Up to ~Day 15)|All safety analyses were based on a subset of the ITT population (the Safety Population), which included randomized participants who received any amount (i.e., full or partial dose) of study drug. All participants received their randomly assigned treatments, and no participants with important deviations were excluded from the safety population.|||Percentage of Participants|||Number
2609077|NCT02070757|Secondary|Percentage of Participants With Any Serious Adverse Event (SAE)|A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.|Up to 35 days after last dose of study drug (Up to ~Day 50)|All safety analyses were based on a subset of the ITT population (the Safety Population), which included randomized participants who received any amount (i.e., full or partial dose) of study drug. All participants received their randomly assigned treatments, and no participants with important deviations were excluded from the safety population.|||Percentage of Participants|||Number
2609094|NCT02070744|Secondary|PC Phase: Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 12|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Baseline was defined as Day 1 of PC Phase.|Baseline (PC Phase), Through Week 12|FAS was defined as all randomized participants who received at least 1 dose of study drug in PC Phase.|||units on a scale||95% Confidence Interval|Least Squares Mean
2609078|NCT02070757|Secondary|Percentage of Participants Who Report 1 or More Adverse Event (AE)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Up to 35 days after last dose of study drug (Up to ~Day 50)|All safety analyses were based on a subset of the ITT population (the Safety Population), which included randomized participants who received any amount (i.e., full or partial dose) of study drug. All participants received their randomly assigned treatments, and no participants with important deviations were excluded from the safety population.|||Percentage of Participants|||Number
2609079|NCT02070757|Secondary|Percentage of Participants With Clinical Response of Clinical Cure at the Late Follow-up (LFU) Visit in the Clinically Evaluable (CE) Population|"To compare the clinical response rates at the Late Follow-up (LFU) visit for ceftolozane/tazobactam versus meropenem in the CE population. Clinical response at the LFU visit will be classified as sustained cure, relapse, or indeterminate only in participants deemed a clinical cure at the TOC visit. A favorable clinical response is sustained clinical cure."|28 to 35 days after the last dose of study drug (Up to ~Day 50)|The CE population was a subset of the ITT population that included any participant who received study drug, adhered to the study protocol through the TOC visit, and had an evaluable clinical outcome (either Cure or Failure) at the TOC visit (or were classified as a clinical failure prior to the TOC visit).|||Percentage of Participants|||Number
2609080|NCT02070757|Secondary|Percentage of Participants With Per-Participant Microbiological Response of Cure or Presumed Cure at the End-of-Therapy (EOT) Visit in the Microbiologically Evaluable (ME) Population|To compare the microbiological response rates of ceftolozane/tazobactam versus meropenem at the EOT visit. The per-participant microbiological response will be determined based on the individual microbiological outcomes for each baseline pathogen. A microbiological response at the EOT visit was defined as cure (baseline pathogens eradicated), failure (baseline pathogen is persistent) or indeterminate (no evaluable respiratory material). A favorable microbiological response is a microbiological cure or presumed cure. The data-as-observed (DAO) approach was used where participants with missing clinical responses, including indeterminate outcomes, are excluded from the analysis population.|Within 24 hours after last dose of study drug (Up to ~Day 15)|The ME population was a subset of the mITT population that included any participants who adhered to the study protocol through the TOC visit, had an evaluable clinical outcome (Cure or Failure) at the TOC visit and had at least 1 bacterial respiratory pathogen (at the appropriate CFU/mL threshold) isolated from the baseline LRT culture.|||Percentage of Participants||95% Confidence Interval|Number
2609081|NCT02070757|Secondary|Percentage of Participants With Clinical Response of Clinical Cure at the End-of-Therapy (EOT) Visit in the Intent-to-Treat (ITT) Population|To compare the clinical response rates at the EOT visit for ceftolozane/tazobactam versus meropenem. Clinical response at the EOT visit was defined as cure (complete resolution with no new signs of VNP), failure (progression, relapse or recurrence of VNP) or indeterminate (no evaluable study data). A favorable clinical response is a clinical cure. A missing clinical response will be considered indeterminate.|Within 24 hours after last dose of study drug (Up to ~Day 15)|The ITT population consisted of all randomized participants with documented informed consent, regardless of whether or not they received study drug.|||Percentage of Participants||95% Confidence Interval|Number
2609082|NCT02070757|Secondary|Percentage of Participants With All-Cause Mortality in the Intent-to-Treat (ITT) Population - Day 14|To compare the all cause mortality rates of participants (ceftolozane/tazobactam versus meropenem arms). Participants whose Day 14 mortality outcomes are missing or unknown are analysed as deceased.|Day 14|The ITT population consisted of all randomized participants with documented informed consent, regardless of whether or not they received study drug.|||Percentage of Participants||95% Confidence Interval|Number
2609083|NCT02070757|Secondary|Percentage of Participants With Microbiological Response of Eradication or Presumed Eradication, by Pathogen, at the Test-of-Cure (TOC) Visit in the Microbiologically Evaluable (ME) Population (>=10 Isolates at Baseline)|"To compare the percentage of participants with a microbiological outcome of eradication or presumed eradication, by pathogen. The microbiological outcome was classified as eradication, presumed eradication, persistence, 'presumed persistence, indeterminate or recurrence. Eradication was defined as a ≥1- log reduction in bacterial burden of the original baseline LRT pathogen AND a per pathogen count of ≤10^4 colony-forming unit (CFU)/mL for endotracheal aspirate (ETA) or sputum specimens, ≤10^3 CFU/mL for a bronchoalveolar lavage (BAL) specimen, or ≤10^2 CFU/mL for a protected brush specimen (PBS) from a follow-up LRT culture. Presumed eradication was defined as an absence of material to culture (e.g. inability to obtain a culture in an extubated patient) in a patient deemed a clinical cure."|7 to 14 days after last dose of study drug (Up to ~Day 30)|The ME population included any participants in the mITT who adhered to the protocol, had an evaluable clinical outcome at TOC and at least 1 pathogen isolated from the baseline LRT culture at the appropriate CFU/mL threshold. The number analyzed per pathogen represents the number of participants in the ME population with that specific pathogen.|||Percentage of Participants||95% Confidence Interval|Number
2609084|NCT02070757|Secondary|Percentage of Participants With Per-Participant Microbiological Response of Cure or Presumed Cure at the Test-of-Cure (TOC) Visit in the Microbiologically Evaluable (ME) Population|To compare the per-participant microbiological response rates of ceftolozane/tazobactam versus meropenem at the TOC visit in the microbiologically evaluable (ME) population. The per-participant microbiological response will be determined based on the individual microbiological outcomes for each baseline pathogen. A microbiological response at the TOC visit was defined as cure (baseline pathogens eradicated), failure (baseline pathogen is persistent) or indeterminate (no evaluable respiratory material). A favorable microbiological response is a microbiological cure or presumed cure. The data-as-observed (DAO) approach was used where participants with missing clinical responses, including indeterminate outcomes, are excluded from the analysis population.|7 to 14 days after last dose of study drug (Up to ~Day 30)|The ME population was a subset of the mITT population that included any participants who adhered to the study protocol through the TOC visit, had an evaluable clinical outcome (Cure or Failure) at the TOC visit and had at least 1 bacterial respiratory pathogen (at the appropriate CFU/mL threshold) isolated from the baseline LRT culture.|||Percentage of Participants||95% Confidence Interval|Number
2609085|NCT02070757|Secondary|Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population|To compare the clinical response rates of ceftolozane/tazobactam versus meropenem in adult participants with VNP (participants with either ventilator-associated bacterial pneumonia [VABP] or ventilated hospital-acquired bacterial pneumonia [HABP]) at the TOC visit in the CE population. Clinical response at the TOC visit was defined as cure (complete resolution with no new signs of VNP), failure (progression, relapse or recurrence of VNP) or indeterminate (no evaluable study data). A favorable clinical response is a clinical cure. A missing clinical response will be considered indeterminate unless the clinical outcome at the EOT visit was failure. The data-as-observed (DAO) approach was used where participants with missing clinical responses, including indeterminate outcomes, are excluded from the analysis population.|7 to 14 days after last dose of study drug (Up to ~Day 30)|The CE population was a subset of the ITT population that included any participant who received study drug, adhered to the study protocol through the TOC visit, and had an evaluable clinical outcome (either Cure or Failure) at the TOC visit (or were classified as a clinical failure prior to the TOC visit).|||Percentage of Participants||95% Confidence Interval|Number
2609086|NCT02070757|Secondary|Percentage of Participants With All Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population - Day 28|To compare the all cause mortality rates of participants in the ceftolozane/tazobactam versus meropenem arms in microbiological intent-to-treat (mITT) population.|Day 28|The mITT population was a subset of the ITT population that included any participant who received any amount of study drug and had at least 1 bacterial respiratory pathogen isolated from the baseline LRT culture that was susceptible to at least 1 of the study drugs.|||Percentage of Participants||95% Confidence Interval|Number
2609087|NCT02070757|Secondary|Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Intent-to-Treat (ITT) Population|To demonstrate the non-inferiority of ceftolozane/tazobactam versus meropenem in adult participants with ventilated nosocomial pneumonia (VNP) at the TOC visit (7 to 14 days after the end-of-therapy [EOT] visit) using a non-inferiority margin of 12.5%. Clinical response at the TOC visit was defined as cure (complete resolution with no new signs of VNP), failure (progression, relapse or recurrence of VNP) or indeterminate (no evaluable study data). A favorable clinical response is a clinical cure. A missing clinical response will be considered indeterminate unless the clinical outcome at the EOT visit was failure. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights.|7 to 14 days after last dose of study drug (Up to ~Day 30)|The ITT population consisted of all randomized participants with documented informed consent, regardless of whether or not they received study drug.|||Percentage of Participants||95% Confidence Interval|Number
2609088|NCT02070757|Primary|Percentage of Participants With All Cause Mortality in the Intent-to-Treat (ITT) Population - Day 28|To demonstrate the non-inferiority of ceftolozane/tazobactam versus meropenem in stratified adult participants with ventilated nosocomial pneumonia (VNP) (participants with either ventilator-associated bacterial pneumonia [VABP] or ventilated hospital-acquired bacterial pneumonia [HABP]) based on the difference in all-cause mortality rates in the intent to treat (ITT) population using a non-inferiority margin of 10%. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights.|Day 28|The ITT population consisted of all randomized participants with documented informed consent, regardless of whether or not they received study drug.|||Percentage of Participants||95% Confidence Interval|Number
2609089|NCT02070744|Secondary|PC Phase: Time to Reach Cmax (Tmax) of VX-661 and IVA||Pre-dose, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 85|Analysis population included all participants who received a dose of VX-661 and IVA, whether the participant completed dosing or not and if the dataset(s) supported the noncompartmental analyses.|||hour||Full Range|Median
2609090|NCT02070744|Secondary|PC Phase: Area Under the Concentration Versus Time Curve From Time 0 to 12 Hours (AUC0-12h) of IVA||Pre-dose, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 85|Analysis population included all participants who received a dose of VX-661 and IVA, whether the participant completed dosing or not and if the dataset(s) supported the noncompartmental analyses. Here, “Number of participants analyzed” signifies those participants who were evaluable for this outcome measure.|||hr*ng/mL||Standard Deviation|Mean
2609091|NCT02070744|Secondary|PC Phase: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24h) of VX-661|Pharmacokinetic (PK) sampling was performed up to 12 hours post-dose on Day 85. For Arm VX-661 50 mg q12h + IVA 150 mg q12h (VX-661 q12h regimen), area under the concentration versus time curve from time 0 to 12 hours (AUC0-12h) was multiplied by 2 to obtain AUC0-24h.|Pre-dose, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 85|Analysis population included all participants who received a dose of VX-661 and IVA, whether the participant completed dosing or not and if the dataset(s) supported the noncompartmental analyses. Here, “Number of participants analyzed” signifies those participants who were evaluable for this outcome measure.|||Hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
2609092|NCT02070744|Secondary|PC Phase: Maximum Plasma Concentration (Cmax) of VX-661 and IVA||Pre-dose, 2, 3, 4, 6, 9 and 12 hours post-dose on Day 85|Analysis population included all participants who received a dose of VX-661 and IVA, whether the participant completed dosing or not and if the dataset(s) supported the noncompartmental analyses.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2609093|NCT02070744|Secondary|OLE Phase: Absolute Change From Baseline in CFQ-R Respiratory Domain Score Through Week 40|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Baseline was defined as Day 1 of the OLE Phase.|Baseline (OLE Phase), Through Week 40|Analysis population was defined as all participants who received at least 1 dose of study drug in the OLE Phase.|||units on a scale||95% Confidence Interval|Least Squares Mean
2609095|NCT02070744|Secondary|OLE Phase: Absolute Change From Baseline BMI at Week 40|BMI was calculated using following formula: BMI = Weight in kg/height in m^2. Baseline was defined as Day 1 of the OLE Phase.|Baseline (OLE Phase), Week 40|Analysis population was defined as all participants who received at least 1 dose of study drug in the OLE Phase.|||kg/m^2||95% Confidence Interval|Least Squares Mean
2610872|NCT02048878|Primary|Systolic Arterial Pressure Reactivity|Increase in blood pressure to stress|within 2 months after enrollment||||mmHg||Standard Deviation|Mean
2609096|NCT02070744|Secondary|PC Phase: Absolute Change From Baseline Body Mass Index (BMI) at Week 12|BMI was calculated using following formula: BMI = Weight in kg/height in square meter (m^2). Baseline was defined as Day 1 of PC Phase.|Baseline (PC Phase), Week 12|FAS was defined as all randomized participants who received at least 1 dose of study drug in PC Phase.|||Kilogram per square meter (kg/m^2)||95% Confidence Interval|Least Squares Mean
2609097|NCT02070744|Secondary|OLE Phase: Absolute Change From Baseline in Body Weight at Week 40|Baseline was defined as Day 1 of the OLE Phase.|Baseline (OLE Phase), Week 40|Analysis population was defined as all participants who received at least 1 dose of study drug in the OLE Phase.|||kg||95% Confidence Interval|Least Squares Mean
2609098|NCT02070744|Secondary|PC Phase: Absolute Change From Baseline in Body Weight at Week 12|Baseline was defined as Day 1 of PC Phase.|Baseline (PC Phase), Week 12|FAS was defined as all randomized participants who received at least 1 dose of study drug in PC Phase.|||kilogram (kg)||95% Confidence Interval|Least Squares Mean
2609099|NCT02070744|Secondary|OLE Phase: Absolute Change From Baseline in Sweat Chloride Through Week 40|Sweat samples were collected using an approved collection device. Baseline was defined as Day 1 of the OLE Phase.|Baseline (OLE Phase), Through Week 40|Analysis population was defined as all participants who received at least 1 dose of study drug in the OLE Phase. Here, “Number of participants analyzed” signifies those participants who were evaluable for this outcome measure.|||mmol/L||95% Confidence Interval|Least Squares Mean
2609100|NCT02070744|Secondary|PC Phase: Absolute Change From Baseline in Sweat Chloride Through Week 12|Sweat samples were collected using an approved collection device. Baseline was defined as Day 1 of PC Phase.|Baseline (PC Phase), Through Week 12|FAS was defined as all randomized participants who received at least 1 dose of study drug in PC Phase. Here, “Number of participants analyzed” signifies those participants who were evaluable for this outcome measure.|||Millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2609101|NCT02070744|Secondary|OLE Phase: Relative Change From Baseline in Percent Predicted FEV1 Through Week 40|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Baseline was defined as Day 1 of the OLE Phase.|Baseline (OLE Phase), Through Week 40|Analysis population was defined as all participants who received at least 1 dose of study drug in the OLE Phase.|||Percent change||95% Confidence Interval|Least Squares Mean
2609102|NCT02070744|Secondary|PC Phase: Relative Change From Baseline in Percent Predicted FEV1 Through Week 12|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Baseline was defined as Day 1 of PC Phase.|Baseline (PC Phase), Through Week 12|FAS was defined as all randomized participants who received at least 1 dose of study drug in PC Phase.|||Percent change||95% Confidence Interval|Least Squares Mean
2609103|NCT02070744|Secondary|OLE Phase: Absolute Change From Baseline in Percent Predicted FEV1 Through Week 40|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Baseline was defined as Day 1 of the OLE Phase.|Baseline (OLE Phase), Through Week 40|Analysis population was defined as all participants who received at least 1 dose of study drug in OLE phase.|||Percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
2609104|NCT02070744|Secondary|PC Phase: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 12|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Baseline was defined as Day 1 of PC Phase.|Baseline (PC Phase), Through Week 12|FAS was defined as all randomized participants who received at least 1 dose of study drug in PC Phase.|||Percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
2609105|NCT02070744|Primary|OLE Phase: Number of Participants With Treatment-Emergent AEs and SAEs|AE: Any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, Inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first dose of study drug through the end of study participation considered treatment-emergent. Baseline was defined as Day 1 of the OLE Phase.|Baseline (OLE Phase) up to 364 days|Safety Set was defined as all participants who received at least 1 dose of study drug in OLE Phase.|||Participants|||Count of Participants
2609106|NCT02070744|Primary|PC Phase: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: Any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, Inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first dose of study drug through the end of study participation considered treatment-emergent. Baseline was defined as Day 1 of PC Phase.|Baseline (PC Phase) up to 112 days|Safety Set was defined as all participants who received at least 1 dose of study drug in PC Phase.|||Participants|||Count of Participants
2609107|NCT02070692|Secondary|Number of Participants Experiencing Ovulation After First Use of Study Drug|A third secondary objective is to determine whether taking tamoxifen at this dose compromises ovulation suppression in ENG users. Tamoxifen is known to transiently raise serum estradiol levels, but does not affect gonadotropin release in premenopausal women. Therefore, it is unlikely to interact with the ovulation suppression provided by the implant. However, to further investigate any theoretical interaction between tamoxifen and etonogestrel, urine markers of ovulation will be collected to document ongoing ovulation suppression with intermittent tamoxifen use.|30 days|Number of subjects analyzed are those that provided urine samples. No subject who provided urine samples was excluded from this analysis.|||Participants|||Count of Participants
2609186|NCT02069119|Primary|Cmax of Plasma OPC-108459 in Patients With Persistent AF|Of 20 subjects for whom plasma OPC-108459 concentrations were measured, all subjects were included in the PK analysis.|0, 30, 50 minute and 2, 4, 8, 24 hour||||ng/mL||Standard Deviation|Mean
2609108|NCT02070692|Secondary|Satisfaction (as Recorded on a 100mm Visual Analog Scale Where 0 is Not at All Satisfied and 100mm is Completely Satisfied)|Secondary objective is to determine whether tamoxifen can improve satisfaction with the implant and with bleeding patterns.|180 days|Number of subjects analyzed is the number of subjects who completed a final study visit (either completion of full study or early termination visit) to provide a final estimation of satisfaction.|||units on a scale||Standard Deviation|Mean
2609109|NCT02070692|Primary|Consecutive Bleeding-free Days After Study Drug|Consecutive bleeding-free days after study drug|up to 180 days|Number of subjects analyzed is the number of subjects who started taking the study drug. One subject in the tamoxifen arm and there in the placebo arm did not initiate study drug.|||days||Standard Deviation|Mean
2609110|NCT02070692|Primary|Bleeding/Spotting Days|Bleeding/spotting days|30 days|Number of patients analyzed is number of patients who completed 30 days of follow up. Two subjects in the tamoxifen arm and three in the placebo arm were lost to follow up prior to 30 days.|||days||Standard Deviation|Mean
2609111|NCT02070692|Primary|Bleeding Days|The primary objective of this study is to determine whether tamoxifen taken by users of the ENG implant on an as-needed basis for frequent or prolonged bleeding can reduce the number of bleeding days by at least 40% over 180 days, when compared to placebo.|180 days||||days||Standard Deviation|Mean
2609112|NCT02070640|Secondary|Time to Complete NIRF-C and IOC|The time required to complete NIRF-C and intraoperative cholangiography will be analyzed.|Intraoperative||||minutes||Full Range|Mean
2609113|NCT02070640|Secondary|Incidence of Anatomic Identification With NIRF-C|Incidence of anatomic identification with NIRF-C and intraoperative cholangiography.|Intraoperative||||percentage of biliary anatomy observatio|||Number
2609114|NCT02070640|Primary|Complications Related to ICG|A patient's negative reaction to indocyanine green (ICG) will be monitored from the time of injection through the 2 week post-operative follow-up visit.|From time of injection to 1st post-op follow-up||||% of Participants with Complications|||Number
2609115|NCT02070588|Secondary|Operator Set MRI Parameters|To record operator-adjusted parameters of the novel software on the MRI system|Per-patient 1 to 3 months, until dataset completion 1 yr|Study was terminated and no subject outcome data were collected||||||
2609116|NCT02070588|Secondary|Subject Demographics|To comprehensively collect subject information (i.e. baseline health data, demographics, socioeconomics, injury presentation, post-injury status, and injury type, place, and cause) for mTBI subjects in context of MRI data.|Per-patient 1 to 3 months, until dataset completion 1 yr|Study was terminated and no subject outcome data were collected||||||
2609117|NCT02070588|Primary|mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software|To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including volumetry, Resting State [RS] functional magnetic resonance imaging [fMRI], kurtosis).|Per-patient 1 to 3 months, until dataset completion 1 yr|Study was terminated and no subject outcome data were collected||||||
2609118|NCT02070484|Primary|Oswestry Disability Index|The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.|6 months|One of three NuCel patients withdrew; therefore, analysis comprises two NuCel patients and three DBM patients.|||units on a scale||Standard Deviation|Mean
2609119|NCT02070484|Primary|Oswestry Disability Index|The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.|3 months|One of three NuCel patients withdrew; therefore, analysis comprises two NuCel patients and three DBM patients.|||units on a scale||Standard Deviation|Mean
2609120|NCT02070484|Primary|Oswestry Disability Index|The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.|2 months|One of three NuCel patients withdrew; therefore, analysis comprises two NuCel patients and three DBM patients.|||units on a scale||Standard Deviation|Mean
2609121|NCT02070484|Primary|Oswestry Disability Index|The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.|1 month|One of three NuCel patients withdrew; therefore, analysis comprises two NuCel patients and three DBM patients.|||units on a scale||Standard Deviation|Mean
2609122|NCT02070484|Primary|Oswestry Disability Index|The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.|Baseline||||units on a scale||Standard Deviation|Mean
2609123|NCT02070484|Secondary|Computed Tomography (CT) Scans to Assess Lumbar Bone Fusion|CT scans reviewed by an independent radiologist and scored according to three categories: no fusion, any fusion, solid fusion.|6 and 12 months|The study was terminated due to low enrollment; therefore, CT scans at 6 and 12 months were not conducted.||||||
2609124|NCT02070484|Primary|Oswestry Disability Index|The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.|12 months|One of three NuCel patients withdrew before 12 months; therefore, analysis comprises two NuCel patients and three DBM patients.|||units on a scale||Standard Deviation|Mean
2609125|NCT02070380|Secondary|Lesion-brain Contrast-to-noise Ratio|"The Unit of Measure is contrast-to-noise ratio based on lesions assessed. For each lesion, Lesion-brain Contrast-to-noise Ratio (CNR) = [(SI of lesion - SI of brain)/SD for SI of noise] on Postdose Images of each lesion was calculated for each contrast agent image separately, then the difference in CNR between MultiHance and Dotarem was calculated. The number presented in the result table below is the mean difference in CNR (MultiHance - Dotarem)"|5-10 minutes Postdose||||ratio based on lesions assessed|Lesions|Standard Deviation|Mean
2609126|NCT02070380|Secondary|Lesion to Background Ratio on Post T1-weighed Spin Echo Images|"The Unit of Measure is lesion-to-background ratio based on lesions assessed. For each lesion, Lesion-to-background ratio (LBR) = SI of lesion/SI of brain. Firstly, LBR of each lesion was assessed for each contrast agent postdose image separately, then the difference in LBR between MultiHance and Dotarem was calculated. The number presented in the result table below is the mean difference in LBR postdose (MultiHance - Dotarem)"|5-10 minutes Postdose||||ratio based on lesions assessed|Lesions|Standard Deviation|Mean
2609187|NCT02069119|Primary|Cmax of Plasma OPC-108459 in Patients With Paroxysmal AF|Of 20 subjects for whom plasma OPC-108459 concentrations were measured, 19 subjects were included in the PK analysis, and one subject was excluded.|0, 30, 50 minute and 2, 4, 8, 24 hour||||ng/mL||Standard Deviation|Mean
2609127|NCT02070380|Secondary|Lesion Contrast Enhancement|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days||||Participant Exams|||Number
2609128|NCT02070380|Secondary|Extent of Disease|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days||||participant exams|||Number
2609129|NCT02070380|Secondary|Lesion Internal Morphology|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days||||participant exams|||Number
2609130|NCT02070380|Secondary|Lesion Border Delineation|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days||||participant exams|||Number
2609131|NCT02070380|Primary|Global Diagnostic Preference Between the Two Exams|Assessed by 3 blinded readers for each of the 159 patients who had post-dose exams for both MultiHance, 0.1 mmol/kg and 0.05 mmol/kg doses, and Dotarem 0.1 mmol/kg. Readers assessed whether images with MultiHance were preferred or images with Dotarem were preferred, or whether images after both exams were considered equal. An image set deemed technically inadequate by a blinded reader was excluded from efficacy analysis for that specific reader. Therefore, the number of participant exams evaluated by each reader differed slightly across readers and endpoints.|Comparison of image sets obtained within 2 to 14 days|Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations|||participant exams|||Number
2609132|NCT02070302|Primary|Change From Baseline Jamar Pinch (Unrelated Dominant Hand - Mean Value of All Repetitions/Positions) at Weeks 6, 12,18.|Mean value of one finger and two finger opposition pinch between 1st and 5th and 1st with 4th and 5th phalanges.|Baseline-Week 18||||Pounds of Force (LBF)||Standard Deviation|Mean
2609133|NCT02070302|Primary|Change From Baseline Electrodiagnostics Motor Median Nerve Latency at Week 6, Week 12, and Week 18.|Latency is the interval between the stimulation of a muscle and the observed response measuring nerve conduction speed in milliseconds.|Baseline to Week 18||||milliseconds||Standard Deviation|Mean
2609134|NCT02070302|Primary|Change From Baseline Electrodiagnostics Distal Sensory Median Nerve Latency at Week 6, Week 12, and Week 18.|Latency is the interval between the stimulation of a muscle and the observed response, measuring conduction speed in milliseconds compared to baseline|Baseline, week 6, week 12, and week 18.||||milliseconds||Standard Deviation|Mean
2609135|NCT02070302|Primary|Change From Baseline in Median Nerve Compression on Neuromuscular Ultrasound at Week 6, Week 12, and Week 18.|Neuromuscular ultrasound measures nerve compression (swelling) by cross sectional area of median nerve, in format % change from baseline.|Baseline to Week 18||||% change||Standard Deviation|Mean
2609136|NCT02070302|Primary|Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18.|Patients with Levine score of < 4 were included in the study. The score for this assessment can range from 8-40|Baseline-Week 18|Levine functional severity scale is a measure of mean of median value calculated for both Onabot and Placebo groups based on patient answered questions. This scale ranges from 1 (no symptoms) to 5 (severe symptoms). The function severity scale indicate interference of the symptoms on activities of daily living. Mean values reported for each group.|||Scores on a scale||Standard Deviation|Mean
2609137|NCT02070302|Primary|Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18.|Patients with Levine score < 4 were included in the study. The score for this assessment can range from 11-55.|Baseline-Week 18|Levine symptom severity scale is a measure of mean of median value calculated for both Onabot and Placebo groups based on patient answered questions. It ranges from 1 (no symptoms) to 5 (severe symptoms). This scale indicate how severe the CTS symptoms feel to the patient. Mean values (std deviation) are reported both Onabot and Placebo groups.|||Scores on a scale||Standard Deviation|Mean
2609138|NCT02070276|Secondary|Post-anesthesia Fluid Amount|Another secondary objective is to quantify the water administration among the three comparison groups after spinal anesthesia, using the patients in the control group as a reference, in order to assess whether the techniques of filling, titrate echocardiographic evaluations and/or response to the mobilization of internal liquids are associated with lower dose, does not require more liquid.|30 minutes||||ml||Standard Deviation|Mean
2609139|NCT02070276|Secondary|Pre-anesthesia Fluid Amount|A secondary objective is to quantify the water administration among the three comparison groups before spinal anesthesia, using the patients in the control group as a reference, in order to assess whether theses techniques are associated with more fluid administration.|Time between operating room entry and spinal anesthesia||||ml||Standard Deviation|Mean
2609423|NCT02065336|Secondary|Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Terminal Elimination Half-Life (t1/2), Cohorts 1-5||Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdose|PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.|||hours||Full Range|Median
2609140|NCT02070276|Primary|Percentage of Participants With Systemic Hypotensions|Primary objective is to quantify significant hypotension rate after spinal anesthesia in patients brought to euvolemia according to the Trans-Thoracic Echocardiography and PLRT (Passive Leg Raising Test), compared to patients treated with the current standard. For arterial hypotension, in accordance with the international standard definitions, now define a drop in systolic blood pressure over 50 mmHg from baseline, an absolute value of systolic blood pressure less than 80 mm Hg, a mean arterial pressure below 60 mmHg or hypotension clinically symptomatic (dizziness, pallor, sweating, nausea).|30 minutes|Participants with Systemic Hypotensions|||Participants|||Count of Participants
2609141|NCT02070237|Secondary|Supraprophylactic Range Anti Xa Level|We will assess if any of the subjects has an Anti Xa level that is in the supraprophylactic range (treatment range).|3.5-4 hours after the third dose of Lovenox (enoxaparin)||||participants|||Number
2609142|NCT02070237|Primary|Anti Xa Level|Our primary outcome will be to assess the Anti Xa level drawn 3.5-4 hours after the third dose of Lovenox (enoxaparin) to assess if this is in the prophylactic range.|3.5-4 hours after the third dose of Lovenox (enoxaparin)||||IU/mL||95% Confidence Interval|Mean
2609143|NCT02069704|Secondary|Volume of Distribution (Vd) of BEVZ92 and Avastin®|Secondary PK endpoints included the Vd calculated at Cycle 7|Vd: 0 to 336 hours after the administration of the Cycle 7 infusion.|In the Avastin arm there were several missing samples at the timepoint required for the specific PK parameter|||L||Geometric Coefficient of Variation|Geometric Least Squares Mean
2609144|NCT02069704|Secondary|Elimination Rate Constant (Kel) of BEVZ92 and Avastin®|Secondary PK endpoints included the Kel calculated at Cycle 7 (Ctrough,ss)|Kel: 0 to 336 hours after the administration of the Cycle 7 infusion.|Overall number of participants Analyzed equals to number of subjects who contributed to summary statistics.|||l/h||Geometric Coefficient of Variation|Geometric Least Squares Mean
2609145|NCT02069704|Secondary|Elimination Half-life (t1/2) of BEVZ92 and Avastin®|Secondary PK endpoints included the t1/2 calculated at Cycle 7|t1/2: 0 to 336 hours after the administration of the Cycle 7 infusion.|In the Avastin arm there were several missing samples at the timepoint required for the specific PK parameter|||h||Geometric Coefficient of Variation|Geometric Least Squares Mean
2609146|NCT02069704|Secondary|Ctrough,ss of BEVZ92 and Avastin®|Secondary PK endpoints included the Ctrough calculated at Cycle 7 (Ctrough,ss)|Ctrough, ss: 0 to 336 hours after the administration of the Cycle 7 infusion.|There were 4 missing samples (1 in the BEVZ92 and 3 in the Avastin arm) at the timepoint required for the specific PK parameter within Cycle 7.|||ng/mL||Geometric Coefficient of Variation|Geometric Least Squares Mean
2609147|NCT02069704|Secondary|Ctrough,sd of BEVZ92 and Avastin®|Secondary PK endpoints included the Ctrough calculated at Cycle 1 (Ctrough,sd )|Ctrough, sd: 0 to 336 hours after start of the first infusion.|In the Avastin arm there was 1 missing samples at the timepoint required for the specific PK parameter within Cycle 1.|||ng/mL||Geometric Coefficient of Variation|Geometric Least Squares Mean
2609148|NCT02069704|Secondary|Cmax,ss of BEVZ92 and Avastin®|Secondary PK endpoints included the Cmax calculated at Cycle 7 (Cmax, ss )|Cmax, ss: 0 to 336 hours post-dose after the administration of Cycle 7 infusion (Week 13)|In the Avastin arm there were 3 missing samples at the timepoint required for the specific PK parameter within Cycle 7.|||ng/mL||Geometric Coefficient of Variation|Geometric Least Squares Mean
2609149|NCT02069704|Secondary|Progression-free Survival (PFS) of BEVZ92 and Avastin®|"Compare PFS between the randomized treatment arms. Progression-free survival (PFS) was defined as the time from the randomization date to the date of disease progression using RECIST v1.1, or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions plus 5 mm absolute increase, and/or unequivocal progression of known non-target lesion, and/or the appearance of new lesions."|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 weeks.|Intent-to-treat population|||months||95% Confidence Interval|Median
2609150|NCT02069704|Secondary|Cmax,sd of BEVZ92 and Avastin®|Secondary PK endpoints included the Cmax calculated at Cycle 1 (Cmax,sd )|Cmax, sd: 0 to 336 hours after start of the first infusion.|Overall number of participants Analyzed equals to number of subjects who contributed to summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Least Squares Mean
2609151|NCT02069704|Secondary|Objective Response Rate (ORR) of BEVZ92 and Avastin®|"To compare efficacy in terms of ORR between arms. Clinical and radiological tumor assessments were performed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using computed tomography (CT) or magnetic resonance imaging (MRI) scans.~Objective response (OR) is defined as a best overall response of partial response (PR) or complete response (CR) as defined by RECIST v1.1. All participants who did not meet the criteria for CR or PR by the end of the study were considered non-responders."|Every four weeks. Up to 48 weeks|Intent-to-treat population|||Participants|||Count of Participants
2609152|NCT02069704|Secondary|Anti-Drug Antibody (ADA) of BEVZ92 and Avastin®|Immunogenicity profile by means of measurement of ADA developed de novo (seroconversion) after cycle 5, cycle 8, and 12 months after first drug administration (pre-dose).|At baseline, and on Day 1 (pre-dose) of Cycles: 1, 5 and 8, and 12 months after first drug administration|All patients receiving at least one dose of study medication.|||participants|||Number
2609153|NCT02069704|Secondary|Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Reported With BEVZ92 and Avastin®|Compare the safety profile by means of the frequency and severity of TEAEs and SAEs reported in each treatment arm.|From first study dose and up to 30 days after the end of study treatment for each patient, for an average of 11 months|All patients receiving at least one dose of study medication.|||participants|||Number
2609154|NCT02069704|Primary|AUC at Steady State (AUCss) of BEVZ92 and Avastin®|"To compare the PK profile of BEVZ92 and Avastin®, both administered in combination with FOLFOX (any) or FOLFIRI, by means of comparing the truncated area under the concentration-versus-time curve calculated over a dosage interval at steady state (i.e. at Cycle 7; AUCss).~For the PK similarity assessments, regulatory guidelines on bioequivalence were followed whereby two treatments are judged not to be different from one another if the 90% CI of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80-125%."|AUCss: 0 to 336 hours after the administration of Cycle 7 infusion (Week 13).|In the Avastin arm there were 3 missing samples at the timepoint required for the specific PK parameters within Cycle 7.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Least Squares Mean
2609155|NCT02069704|Primary|Area Under the Concentration-versus-time Curve (AUC) at Cycle 1 (AUC0-336h) of BEVZ92 and Avastin®|"To compare the pharmacokinetic (PK) profile of BEVZ92 and Avastin®, both administered in combination with FOLFOX (any) or FOLFIRI, by means of comparing the truncated AUC calculated from start of the first infusion until start of the second infusion (i.e. at Cycle 1; AUC0-336h)~For the PK similarity assessments, regulatory guidelines on bioequivalence were followed whereby two treatments are judged not to be different from one another if the 90% confidence interval (CI) of the ratio of a log-transformed exposure measure (AUC) falls completely within the range 80-125%."|AUC0-336 hrs: 0 to 336 hours after start of the first infusion|Overall number of participants Analyzed equals to number of subjects who contributed to summary statistics.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Least Squares Mean
2609156|NCT02069392|Secondary|Change in Working Memory Capacity|Derived from a computerized change localization task. One to four colored squares are shown for 100 ms. After a delay, they reappear and the task is to click on the one square that has changed color (50% chance). Performance is expressed as the percentage of correct responses.|baseline (week 1) and post-intervention (week 10)||||percentage correct responses||Standard Deviation|Mean
2609157|NCT02069392|Secondary|Training Exercise Parameters: Visual and Sound Sweeps|"Some of the Posit Science exercises provide an assessment tool of training progress on task parameters, which adjust continuously to keep performance at ~85% correct. Enhanced sensory processing speed and precision is considered the central building block of training benefits. Therefore, we analyzed the two exercises aimed at training these processes. Performance is quantified as stimulus presentation time in ms of visual or sound sweeps, which the participant has to judge in terms of change across space or time. Smaller values reflect better performance. Visual and sound sweeps were averaged."|baseline (week 0), post-intervention (week 10), 4-week follow-up||||ms||Standard Deviation|Mean
2609158|NCT02069392|Secondary|Brief Psychiatric Rating Scale (BPRS) Score|Clinician rating scale to measure psychotic symptoms. Each of 20 items is scored 1-7. Total scores are the sum of all items and range from 20 to 140, with larger values reflecting worse symptoms.|baseline (week 0), post-intervention (week 10)||||score on a scale||Standard Deviation|Mean
2609159|NCT02069392|Secondary|Scale for the Assessment of Negative Symptoms (SANS) Score|Clinician rating scale of negative symptoms in schizophrenia. Within each of 5 domains, separate symptoms are rated from 0 (absent) to 5 (severe). Total scores are the sum of 22 subscales and range from 0 to 110, with larger values reflecting higher negative symptoms.|baseline (week 0), post-intervention (week 10)||||score on a scale||Standard Deviation|Mean
2609160|NCT02069392|Secondary|Calgary Depression Scale Score|Clinician scale developed to assess the level of depression in schizophrenia. 9 items assess symptoms of depression and overall rater impression on a scale from 0 (absent) to 3 (severe).|baseline (week 0), post-intervention (week 10)||||score on a scale||Standard Deviation|Mean
2609161|NCT02069392|Secondary|UCSD Performance-Based Skills Assessment (UPSA) Score|Measures ability to perform real-life tasks by standardized role-play. Scores reflect percent correct, i.e. range from 0-100 with higher scores representing better performance.|baseline (week 0) and post-intervention (week 10)||||score on a scale||Standard Deviation|Mean
2609162|NCT02069392|Secondary|Change in Abbreviated Schizophrenia Quality of Life Scale Score|Semi-structured clinician interview measuring functional outcome and quality of life in people with schizophrenia. Includes subjective questions regarding life satisfaction and objective indicators of social and occupational role functioning during preceding 4 weeks. Seven items are scored on a 0 (severe impairment) to 6 (high functioning) scale. The total score ranges from 0 to 42, with larger values reflecting higher functioning.|baseline (week 0) and post-intervention (week 10)||||score on a scale||Standard Deviation|Mean
2609163|NCT02069392|Secondary|Cognitive Assessment Interview (CAI) Score|Clinician-administered interview about daily life cognitive functioning. The CAI assesses 10 items related to working memory, attention/vigilance, learning/memory, problem solving, processing speed, and social cognition. The total score ranges from 1 (inability to maintain personal hygiene due to cognitive deficits) to 100 (superior cognitive functioning in a wide range of activities). A score of 55 corresponds to moderate cognitive symptoms, e.g. persistent problems paying attention or forgetting scheduled events.|baseline (week 0) and post-intervention (week 10)||||score on a scale||Standard Deviation|Mean
2609164|NCT02069392|Primary|MATRICS Consensus Cognitive Battery (MCCB) Composite Score|The MCCB is an FDA-approved assessment tool for trials of cognition-enhancing treatments in people with schizophrenia. The MCCB is comprised of the following domains: 1) Speed of Processing; 2) Attention/Vigilance; 3) Working Memory; 4) Verbal Learning; 5) Visual Learning; 6) Reasoning and Problem Solving; and 7) Social Cognition. The composite score is standardized to a T-scale (mean=50, standard deviation=10) based on healthy control normative data. Better performance is reflected by higher scores.|baseline (week 0), weeks 4 and 7 of intervention, end-of-intervention (week 10), 4-week follow-up||||score on a scale||Standard Deviation|Mean
2609165|NCT02069379|Secondary|Beck Depression Index|Measure of depression symptoms at baseline in controls and insulin resistant women. The Beck Depression Index runs on a scale from 0 to 63 where low scores mean less depression and high scores mean greater depression. Clinically, scores of 14 or higher are considered mild depression; 20 is moderate and 29 is severe.|Baseline|All women assessed at baseline, prior to treatment arm randomization, so all insulin resistant women analyzed as a single group. The data for one woman in the control group is unavailable. Note: women with BDI scores of greater than 20 were excluded from the study by definition and therefore could not be in either arm.|||units on a scale||Standard Deviation|Mean
2609166|NCT02069379|Secondary|Profile of Mood States - Overall Negative Mood|Measure of overall negative mood at baseline in controls and insulin resistant women; Profile of Mood States are standardized to a relative score where a higher score is a worse mood state. Standardized cores generally ranged from - 11 to 52.|Baseline|All women assessed at baseline, prior to treatment arm randomization, so all insulin resistant women analyzed as a single group; one woman on the control side's data is not available|||units on a scale||Standard Deviation|Mean
2609188|NCT02069119|Primary|Subjects Achieving NSR in Patients With Persistent AF|"24 subjects with persistent AF, 6 subjects per cohort (5 for OPC-108459 and one for placebo), 4 dose steps; Step 1: 0.4 mg/kg, Step 2: 0.8 mg/kg, Step 3: 1.6 mg/kg, Step 4: 2.6 mg/kg~The number of subjects achieving NSR within 90 minutes after the start of IMP administration and sustaining NSR for at least one minute.~No subjects achieved NSR within 90 minutes after the start of IMP administration in the persistent AF cohort."|90 minutes||||Participants|||Count of Participants
2609167|NCT02069379|Secondary|Positive and Negative Affect Schedule - Negative Affective State|"Measure of overall negative affective state at baseline in controls and insulin resistant women.~Positive and Negative Affect Schedule - negative affective state. Scores can range from 10-50, with higher scores representing more negative affective state (worse outcome)"|Baseline|All women assessed at baseline, prior to treatment arm randomization, so all insulin resistant women analyzed as a single group. One woman's baseline affective score is not available.|||units on a scale||Standard Deviation|Mean
2609168|NCT02069379|Secondary|Positive and Negative Affect Schedule - Positive Affective State|Compare positive affective state between controls and insulin resistant women. Positive and Negative Affect Schedule - positive affective state. Scores can range from 10-50, with higher scores representing more positive affective state (better outcome)|Baseline|All women assessed at baseline, prior to treatment arm randomization, so all insulin resistant women are analyzed as a single group. On the Control side, one woman's data for affective state is unavailable.|||units on a scale||Standard Deviation|Mean
2609169|NCT02069379|Primary|Mu-opioid Receptor Binding Potential in Right Amygdala, Resting State|Mu-opioid neurotransmission in limbic brain regions at baseline and change from baseline after metformin treatment|Baseline, 20 weeks, 40 weeks|PET scanners available were replaced for other institutional reasons which resulted in image production so incompatible as to be not comparable. Therefore PET image data files were unable to be analyzed due to inconsistencies with imaging techniques.||||||
2609170|NCT02069379|Primary|Mu-opioid Receptor Binding Potential in Left Amygdala, Resting State|Mu-opioid neurotransmission in limbic regions at baseline and change from baseline after metformin treatment|Baseline, 20 weeks, 40 weeks|PET scanners available were replaced for other institutional reasons which resulted in image production so incompatible as to be not comparable. Therefore PET image data files were unable to be analyzed due to inconsistencies with imaging techniques.||||||
2609171|NCT02069379|Primary|Mu-opioid Receptor Binding Potential in Right Nucleus Accumbens, Resting State|Mu-opioid neurotransmission in limbic brain regions at baseline and change from baseline after metformin treatment|Baseline, 20 weeks, 40 weeks|PET scanners available were replaced for other institutional reasons which resulted in image production so incompatible as to be not comparable. Therefore PET image data files were unable to be analyzed due to inconsistencies with imaging techniques.||||||
2609172|NCT02069379|Primary|Mu-opioid Receptor Binding Potential in Left Nucleus Accumbens, Resting State|Mu-opioid neurotransmission in limbic brain regions at baseline and change from baseline after metformin treatment|Baseline, 20 weeks, 40 weeks|PET scanners available were replaced for other institutional reasons which resulted in image production so incompatible as to be not comparable. Therefore PET image data files were unable to be analyzed due to inconsistencies with imaging techniques.||||||
2609173|NCT02069353|Secondary|Device Malfunction||Participants will be followed for the duration of invasive monitoring, an expected average of 5 days||||Participants|||Count of Participants
2609174|NCT02069353|Secondary|Monitor-associated Infection||Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks||||Participants|||Count of Participants
2609175|NCT02069353|Secondary|Clinically Significant Bleeding||Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks||||Participants|||Count of Participants
2609176|NCT02069353|Primary|Cerebral Hypoperfusion||Participants will be followed for the duration of invasive monitoring, an expected average of 5 days||||Participants|||Count of Participants
2609177|NCT02069353|Primary|Occult Seizures|Seizures detected by intracortical EEG but not surface EEG|Participants will be followed for the duration of invasive monitoring, an expected average of 5 days||||Participants|||Count of Participants
2609178|NCT02069353|Primary|Spreading Depolarizations||Participants will be followed for the duration of invasive monitoring, an expected average of 5 days||||Participants|||Count of Participants
2609179|NCT02069184|Secondary|Pain Medication Usage ( NSAIDS)|Compare the percentage of patients using non-opioid pain medication at 24 hours, and 48 hours and had experienced any adverse events.|For the first 24 hours after the c-section until the patient is discharged or up to 48 hours||||percentage of patients|||Number
2609180|NCT02069184|Secondary|Percentage of Participants That Were Re-Hospitalized 1 Week After Discharge|No patients were re hospitalized in the first 7 days|From time of discharge to 1 week after discharge||||percentage of patients|||Number
2609181|NCT02069184|Secondary|Number of Participants Using Patient-controlled Analgesia (PCA) Attempts|Data were not collected.The use of patient-controlled analgesia (PCA) pumps could have been utilized to standardize rescue medications. This would have allowed the collection of the proportion of subjects that required additional rescue medications. This was another possible endpoint that could have been evaluated.|every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or upto 72 hours.|None of the participants used PCA pumps so no data could be collected for this outcome measure. PCA was not part of the standard of care at our hospital.||||||
2609182|NCT02069184|Secondary|"Percentage of Patients With Adverse Events After the Surgery"|Subjects were specifically asked about adverse events such as nausea, vomiting, pruritus and breathing difficulties and information regarding their bowel movements. This information was collected on a scale of none, mild, moderate or severe. These are categorical outcomes.|every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or upto 72 hours. Finally, 1 week after discharge.||||percentage of patients|||Number
2609183|NCT02069184|Secondary|Percentage of Participants Reporting to be Wide Awake up to 72 Hours After the C-section|Sedation was assessed on a scale of 1-3 (1= wide awake, 2= sleepy but easily aroused, 3= sleepy and difficult to arouse). These assessments were made at the same time points as the pain assessments by the same research assistant. Score 1 is the only good outcome.|Percentage of Participants Reporting to be Wide Awake up to 72 hours after the C-section||||percentage of patients|||Number
2609184|NCT02069184|Secondary|Visual Analog Score (VAS) Pain Score|Post-operative pain was assessed using VAS pain scores (0-10 scale) with 10 being the worst|every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or up to 48 hours||||scores on a scale||Standard Deviation|Mean
2609185|NCT02069184|Primary|Opioid Requirements in Cesarean Section (C-section) Patient Population||24 and 48 hours after Cesarean Section||||mg||Standard Deviation|Mean
2609189|NCT02069119|Primary|Subjects Achieving Normal Sinus Rhythm (NSR) in Patients With Paroxysmal AF|"24 subjects with paroxysmal AF, 6 subjects per cohort (5 for OPC-108459 and one for placebo), 4 dose steps; Step 1: 0.4 mg/kg, Step 2: 0.8 mg/kg, Step 3: 1.6 mg/kg, Step 4: 2.6 mg/kg~The number of subjects achieving NSR within 90 minutes after the start of IMP administration and sustaining NSR for at least one minute."|90 minutes||||Participants|||Count of Participants
2609190|NCT02069093|Secondary|Blood Concentration of Everolimus and Exemestane|Blood samples were collected and analyzed.|28 days (pre-dose)|The PK analysis set, which was a subset of the FAS, was considered for the analysis. However, only participants who had evaluable data were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2609191|NCT02069093|Secondary|Dose Intensity of Everolimus and Exemestane|The dose intensity was calculated as the cumulative dose of everolimus or exemestane divided by the length of time on treatment during the first 56 days of treatment.|56 days|FAS: The FAS consisted of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash).|||mg/day||Full Range|Median
2609192|NCT02069093|Secondary|Number of Participants With All Grades of Stomatitis|The number of participants with all grades of stomatitis was defined as the number of participants who had stomatitis grade 1 or higher. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.|56 days|The FAS, consisting of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash), was considered for the analysis. However, only those participants, who were evaluable for stomatitis grade, were analyzed.|||Participants|||Number
2609193|NCT02069093|Secondary|Median Number of Mouthwashes Per Day|The median number of mouthwashes per day was assessed.|56 days|FAS: The FAS set consisted of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash).|||Number of mouthwashes||Full Range|Median
2609194|NCT02069093|Secondary|Time to Resolution of Stomatitis From Grade 2 or Greater to Grade 1 or Less|The number of days to achieve resolution of stomatitis from grade 2 or greater to grade 1 or less was assessed. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.|56 days|FAS: The FAS consisted of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash).|||Days||Full Range|Median
2609195|NCT02069093|Primary|Number of Participants With Stomatitis Grade ≥ 2|The incidence of grade ≥ 2 stomatitis was reported. Grade 1 = minimal symptoms, normal diet; grade 2 = symptomatic, but able to swallow a modified diet; grade 3 = symptomatic and unable to aliment or hydrate orally; and grade 4 = symptoms associated with life-threatening consequences.|56 days|Full analysis set (FAS): The FAS consisted of all participants who received at least one dose of study treatment (everolimus and/or exemestane) and at least one dose of investigational treatment (dexamethasone mouth wash).|||Participants|||Number
2609196|NCT02069041|Secondary|Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version[v] 1.1) criteria.CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size [<10 millimeter (mm) short axis]. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease(PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest).In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.~Percentage of participants with CR or PR= (number of participants whose best overall response was CR or PR)/(number of participants treated)*100."|Response to Disease Progression or Death (Up To 7 Months)|All participants who received at least one dose of study drug.|||percentage of Participants|||Number
2609197|NCT02069041|Secondary|Number of Participants With Anti-Ramucirumab Antibodies||Baseline through 6.1 Months|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2609198|NCT02069041|Secondary|PK:Area Under the Concentration-Time Curve (AUC[0-∞]) of Ramucirumab|Area under the concentration-time curve.|Cycle 1 and Cycle 3: 0,1.0,1.5,2.0,3.0,5.0,24.0,48.0,168.0,336.0 hours|All participants who received at least one dose of study drug and had evaluable PK data.|||microgram*day / milliliter)(ug*day/mL)||Geometric Coefficient of Variation|Geometric Mean
2609199|NCT02069041|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab|Maximum Concentration (Cmax)|Cycle 1 and Cycle 3: 0,1.0,1.5,2.0,3.0,5.0,24.0,48.0,168.0,336.0 hours|All participants who received at least one dose of study drug and had evaluable PK data.|||ug/mL(microgram / milliliter)||Geometric Coefficient of Variation|Geometric Mean
2609200|NCT02069041|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.|Baseline through study completion (Up To 8 Months)|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2609201|NCT02068846|Secondary|"Number of Participants Reporting Dry Mouth Yes/No at Week 12"|"Participants were asked Have you noticed any change in your salivary glands or in the dryness of your mouth"|Week 12||||Participants|||Count of Participants
2609202|NCT02068846|Secondary|"Number of Participants Reporting Dry Mouth Yes/No at Week 4"|"Participants were asked Have you noticed any change in your salivary glands or in the dryness of your mouth"|Week 4||||Participants|||Count of Participants
2609228|NCT02068508|Secondary|Change From Baseline in LDL Cholesterol||Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed was evaluable for this outcome measure.|||mg/dL||Standard Deviation|Mean
2609203|NCT02068846|Secondary|Unstimulated Salivary Flow Rate at Week 12|To determine whether salivary gland function is improved or restored with the administration of Cipro in participants with HIVSGD. After sitting at rest for 1 minute, participants collect drool using 50-mL conical tubes. The 5-minute unstimulated whole saliva flow rate recorded and collected. Salivary hypofunction is defined as unstimulated whole saliva flow rate ≤0.1 mL/min. Normal salivary function is defined as >0.1 mL/min.|Week 12|Two participants withdrew prior to Week 4 and two participants did not perform salivary flow collection.|||Participants|||Count of Participants
2609204|NCT02068846|Secondary|Unstimulated Salivary Flow Rate at Week 4|To determine whether salivary gland function is improved or restored with the administration of Cipro in participants with HIVSGD. After sitting at rest for 1 minute, participants collect drool using 50-mL conical tubes. The 5-minute unstimulated whole saliva flow rate recorded and collected. Salivary hypofunction is defined as unstimulated whole saliva flow rate ≤ 0.1 mL/min. Normal salivary function is defined as > 0.1 mL/min.|Week 4|Two participants withdrew prior to Week 4 and one participant did not perform salivary flow collection.|||Participants|||Count of Participants
2609205|NCT02068846|Primary|BK Viral Status in Saliva at Week 12|Oral fluids will be assessed for evidence of BK Virus replication to determine whether Cipro administration inhibits BK Virus replication in participants with HIVSGD. Oral fluids will be assessed by real-time PCR to determine BK Virus status as positive or negative.|Week 12|Two participants withdrew prior to Week 4|||Participants|||Count of Participants
2609206|NCT02068846|Primary|BK Viral Status in Saliva at Week 4|Oral fluids will be assessed for evidence of BK Virus replication to determine whether Cipro administration inhibits BK Virus replication in participants with HIVSGD. Oral fluids will be assessed by real-time PCR to determine BK Virus status as positive or negative.|Week 4|Two participants withdrew prior to Week 4|||Participants|||Count of Participants
2609207|NCT02068820|Other Pre-specified|Number of Pelvic Sentinal Lymph Nodal Metastasis in Regard to Staining by Immunohistochemical (IHC) Staining in Comparison to Standard Hematoxylin and Eosin (H&E).|Of the 127 positive nodes with pathology information, the percentage of each type of node will be summarized by the staining method. Statistical testing of the individual staining methods compared to both will be computed using Chi-square test of independence.|through 6 weeks post-operative|These are positive sentinel lymph nodes|||nodes|Nodes||Number
2609208|NCT02068820|Secondary|Negative Predictive Value (NPV) of Pelvic SLN in Endometrial Cancer in Relation to the Number of Nodes With Metastasis.|"The standard definition for negative predictive value was used to calculate NPV. There was one false negative SLN in this study, 39 true positive sentinel lymph nodes, and 140 negative pelvic metastatic patients.~NPV = 140/141=99.3%"|through 6 weeks post-operative|Comparison of metastatic disease (yes or no) with ICG dye node detection (yes or no)|||Participants|||Count of Participants
2609209|NCT02068820|Primary|Number of Pelvic Sentinel Lymph Nodes (SLN) in Endometrial Cancer Patients Detected by Either ICG and/or ISB Dyes.||through 6 weeks post-operative|The ISB dye alone group (n=20) and the ICG group (n=180) are combined, because both groups received the ISB dye.|||nodes||Standard Deviation|Mean
2609210|NCT02068768|Secondary|Visual Analog Scale (VAS) of Back Pain|"The pain VAS is a continuous scale comprised of a horizontal line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme of either no pain or worst imaginable pain. The pain VAS is self‐completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. The score is determined by measuring the distance (mm) on the 10‐cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100."|preop, 3 mo, 6 mo, 12 mo|Data were available for 13 participants preoperatively, 12 at 3 months, 8 at 6 months, and 6 at 12 months|||units on a scale||Full Range|Mean
2609211|NCT02068768|Secondary|Mean Oswestry Disability Index (ODI)|The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.|preop, 3 mo, 6 mo, 12 mo post op|Data were available for 13 participants preoperatively, 12 at 3 months, 8 at 6 months, and 6 at 12 months|||score on a scale||Full Range|Mean
2609212|NCT02068768|Primary|Fusion Rate|Number of participants with fused disc space as measured radiographically|12 months after device implantation|Poor enrollment led to early termination and low number of participants available for analysis. Data were available for 13 participants preoperatively, 12 at 3 months, 8 at 6 months, and 6 at 12 months. Only 3 of 6 participants reaching 12 month follow up had radiographs available for analysis.|||Participants|||Count of Participants
2609213|NCT02068599|Secondary|Participants With Treatment-Emergent Adverse Events|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|day 1 up to day 57|Safety analysis population. The safety population includes all randomized participants who receive at least one dose of study medication. In this population, treatment was assigned based upon the treatment participants actually receive regardless of the treatment to which they were randomized.|||Participants|||Count of Participants
2609229|NCT02068508|Secondary|Change From Baseline in HDL Cholesterol||Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed was evaluable for this outcome measure.|||mg/dL||Standard Deviation|Mean
2609230|NCT02068508|Secondary|Change From Baseline in Fasting Triglycerides||Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed was evaluable for this outcome measure.|||mg/dL||Standard Deviation|Mean
2609214|NCT02068599|Secondary|Percentage of Participants Who Are Responders Per Outcome Measures in Rheumatoid Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 4|Participants are classified as 'Yes' if the following criteria are met: - >=50% improvement from baseline and an absolute change >=20 on a scale of 1-100 in either the pain or physical function subscale (WOMAC). or 2 of the 3 criteria as below met: - 1) >=20% improvement from baseline and an absolute change >=10 on a scale of 1-100 in the pain subscale (WOMAC); - 2) >=20% improvement from baseline and an absolute change >=10 on a scale of 1-100 in the physical function subscale (WOMAC); - 3) at least a 20% improvement from baseline and an absolute change >=10 on a scale of 1-100 in PGA. Otherwise, 'No' The responder rate per OMERACT-OARSI criteria was analyzed using a generalized estimating equation (GEE) method, where binary variable responder rate (Yes/No) was modeled through logit link function, with treatment, center, week, and treatment*week as explanatory factors. The unstructured working correlation structure was applied.|Week 4 (day 29)|Full analysis set|||percentage of participants|||Number
2609215|NCT02068599|Secondary|Change From Baseline in the Patient Global Assessment (PGA) Scores at Weeks 2 and 4 Using a Mixed Model for Repeated Measures (MMRM)|PGA is a simple self-report tool for measuring the overall way arthritis is affecting the patient at a particular point in time. There is 1 question and the response is provided on a visual analog scale (VAS) from 0 (very poor) to 100 (very good). The question is: Considering all the ways your arthritis affect you, how are you feeling today? Positive change from baseline scores indicate improvement. The MMRM model includes week, treatment, study center, and treatment by week interaction as the fixed factors; baseline PGA score as a covariate and unconstructed variance-covariance structure.|Baseline (day 1, predose), Week 2 (day 15) and Week 4 (day 29)|Full analysis set of participants with data at the timepoints.|||units on a scale||Standard Error|Least Squares Mean
2609216|NCT02068599|Secondary|Participants' Global Assess of Treatment as Measured by the Patient Global Impression of Change (PGIC) at Weeks 2 and 4 Using a Mixed Model for Repeated Measures (MMRM)|PGIC is a standardized self-report tool that measures the change in a participants overall status rating since the start of treatment on 7-point scale. The 7-point scale is defined as: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. The MMRM model includes week, treatment, study center, and treatment by week interaction as the fixed factors and unconstructed variance-covariance structure.|Weeks 2 (day 15), 4 (day 29)|Full analysis set of participants with data at the timepoint.|||units on a scale||Standard Error|Least Squares Mean
2609217|NCT02068599|Secondary|Change From Baseline (Randomization Visit) to the Week 4 Visit in the Pain Quality Assessment Scale - Revised (PQAS-R) for the Target Knee Using a Mixed Model for Repeated Measures|PQAS-R is a standardized self-report tool that measures various aspects of a participant's pain. There are 19 questions (question 19 has 2 parts) that ask the participant to rate the various aspects (intensity, sharpness, heat, cold, etc.) of his/her pain over the past week on average on a scale of 0 to 10 (0 = not [aspect] and 10 = the most or worst imaginable [aspect]). PQAS-R score at each visit is the sum of responses for the 19 questions for a total range of 0=no pain to 200=worst imaginable pain in all aspects. Negative change from baseline scores indicate improvement in stiffness. MMRM includes week, treatment, study center, and treatment by week interaction as fixed factors; baseline PQAS-R score for the 19 questions (20 parts) as a covariate; and patient as a random factor.|Baseline (day 1, predose), Treatment: Week 4 (day 29)|Full analysis set. If any of the 19 questions is missing, the PQAS-R total score will not be calculated for a given visit. If the entire questionnaire is not done at a scheduled time point, it will be considered missing and will not be imputed.|||units on a scale||Standard Error|Least Squares Mean
2609218|NCT02068599|Secondary|Percentage of Participants With a >=30% and a >=50% Response in Average Evening Pain Intensity of WOMAC Question 1 in the Target Knee During the Last 5 Days of Treatment Compared With Baseline|WOMAC Question 1 is the first question in the pain domain and asks patients to rate their pain in the target knee while walking on a flat surface. The possible score for each item ranges from 0 (no pain) to 100 mm (worst pain). Average pain is calculated using a MMRM which includes week, treatment, study center, and treatment by week interaction as fixed factors; baseline average evening WOMAC Question 1 score as a covariate; and patient as a random factor. Responder rate was calculated as 100 * the value of (average WOMAC pain subscale during the last 5 days of treatment [Days 24 to 28]) - average WOMAC pain subscale at baseline [the 5 days prior to randomization])/average WOMAC pain subscale at baseline (the 5 days prior to randomization). Participants with missing responder rates were treated as nonresponders.|Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)||||percentage of participants|||Number
2609219|NCT02068599|Secondary|Change From Baseline (Randomization Visit) to the Week 4 Visit in the WOMAC Stiffness Subscale Score for the Target Knee Using a Mixed Model for Repeated Measures|The two items in the WOMAC stiffness subscale cover stiffness after first waking and later in the day. WOMAC stiffness subscale score is calculated as the sum of the 2-item stiffness subscale scores (WOMAC) for a total range of 0 (no stiffness) to 200 (worst stiffness on both items). Negative change from baseline scores indicate improvement in stiffness. MMRM includes week, treatment, study center, and treatment by week interaction as fixed factors; baseline stiffness WOMAC scores for the 2-item subscale as a covariate; and patient as a random factor.|Baseline (day 1, predose), Treatment: Week 4 (day 29)|Full analysis set. Both baseline and treatment values must be available for a participant to be included. For stiffness subscale, if both items are missing, the subscale total will not be calculated; otherwise the missing value will be replaced with the non-missing one in the subscale.|||units on a scale||Standard Error|Least Squares Mean
2609231|NCT02068508|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)||Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed was evaluable for this outcome measure.|||Percent||Standard Deviation|Mean
2609232|NCT02068508|Secondary|Change From Baseline in Fasting Blood Glucose||Baseline and Week 12, 24, 36, 52, and final assessment (up to Week 52)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed was evaluable for this outcome measure.|||mg/dL||Standard Deviation|Mean
2612783|NCT02029521|Secondary|White Blood Cell Count|White blood cell count was measure at the beginning and end of the study to determine if treatment affected this test.|6 months|All participants.|||1000 cells/mm^3||Standard Deviation|Mean
2609220|NCT02068599|Secondary|Change From Baseline (Randomization Visit) to the Week 4 Visit in the WOMAC Physical Function Subscale Score for the Target Knee Using a Mixed Model for Repeated Measures|The seventeen items in the WOMAC physical function subscale cover stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. WOMAC physical function subscale score is calculated as the sum of the 17-item physical function subscale scores (WOMAC) for a total range of 0 (no pain) to 1700 (worst pain on all 17 items). Negative change from baseline scores indicate improvement in pain. MMRM includes week, treatment, study center, and treatment by week interaction as fixed factors; baseline physical function WOMAC scores for the 17-item subscale as a covariate; and patient as a random factor.|Baseline (day 1, predose), Treatment: Week 4 (day 29)|Full analysis set. Both baseline and treatment values must be available for a participant to be included. For physical function subscale, if more than 3 items are missing the subscale total will not be calculated; otherwise the missing value will be replaced by the average of the non-missing values in the subscale.|||units on a scale||Standard Error|Least Squares Mean
2609221|NCT02068599|Secondary|Change From Baseline to Last 5 Days of Treatment in the Average Morning Pain Intensity In the Target Knee When Walking on a Flat Surface Using a Mixed Model for Repeated Measures (MMRM)|The Western Ontario and McMasters Universities Arthritis Index [WOMAC] is a widely used, validated, patient-reported questionnaire used to assess pain, stiffness, and physical function in patients with OA of the knee. It consists of 24 items separated into 3 domains (pain [5 items], stiffness [2 items], and physical function [17 items]). The possible score for each item ranges from 0 (no pain) to 100 mm (worst pain). WOMAC Question 1 is the first question in the pain domain and asks patients to rate their pain in the target knee while walking on a flat surface. Participants record their response to WOMAC Question 1 in the study diary based on average pain upon walking since the last assessment or over the past 12 hours. Negative change from baseline scores indicate improvement in pain. MMRM includes week, treatment, study center, and treatment by week interaction as fixed factors; baseline average morning WOMAC Question 1 score as a covariate; and patient as a random factor.|Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)|The full analysis set (FAS) include all patients in the intent to treat (ITT) population who receive at least 1 dose of study drug and have at least 1 post baseline efficacy assessment. Both baseline and treatment values must be available for a participant to be included.|||units on a scale||Standard Error|Least Squares Mean
2609222|NCT02068599|Secondary|Change From Baseline to Last 5 Days of Treatment in the Average Daily WOMAC Pain Subscale Score In the Target Knee Using a Mixed Model for Repeated Measures|The five items in the WOMAC Pain Subscale cover pain during walking, using stairs, in bed, sitting or lying, and standing. Daily WOMAC pain subscale score is calculated as the sum of the 5-item pain subscale scores (WOMAC) recorded at evening for a total range of 0 (no pain) to 500 (worst pain on all 5 items). Negative change from baseline scores indicate improvement in pain. MMRM includes week, treatment, study center, and treatment by week interaction as fixed factors; baseline average evening WOMAC scores for the 5-item pain subscale as a covariate; and patient as a random factor.|Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)|Full analysis set. Both baseline and treatment values must be available for a participant to be included. For pain subscale, if more than 1 item is missing, the subscale total will not be calculated; otherwise the missing value will be replaced by average of the non-missing values in the subscale.|||units on a scale||Standard Error|Least Squares Mean
2609223|NCT02068599|Primary|Change From Baseline to Last 5 Days of Treatment in the Average Evening Pain Intensity In the Target Knee When Walking on a Flat Surface Using a Mixed Model for Repeated Measures (MMRM)|The Western Ontario and McMasters Universities Arthritis Index [WOMAC] is a widely used, validated, patient-reported questionnaire used to assess pain, stiffness, and physical function in patients with OA of the knee. It consists of 24 items separated into 3 domains (pain [5 items], stiffness [2 items], and physical function [17 items]). WOMAC Question 1 is the first question in the pain domain and asks patients to rate their pain in the target knee while walking on a flat surface. The possible score for each item ranges from 0 (no pain) to 100 mm (worst pain). Participants record their response to WOMAC Question 1 in the study diary based on average pain upon walking since the last assessment or over the past 12 hours. Negative change from baseline scores indicate improvement in pain. MMRM includes week, treatment, study center, and treatment by week interaction as fixed factors; baseline average evening WOMAC Question 1 score as a covariate; and patient as a random factor.|Baseline (day -5 to day -1), Last 5 days of treatment (day 24 to day 28)|The full analysis set (FAS) include all patients in the intent to treat (ITT) population who receive at least 1 dose of study drug and have at least 1 post baseline efficacy assessment. Both baseline and treatment values must be available for a participant to be included.|||units on a scale||Standard Error|Least Squares Mean
2609224|NCT02068547|Secondary|Neck Pain Affects Every Day Activities|Questionnaire that helps determine how a subject's neck pain affects their ability to manage every day activities.|24 Months|Study was discontinued prior to data being analyzed.||||||
2609225|NCT02068547|Secondary|Physical and Mental Health From Subject's Point of View|Short Form 36 (SF-36) is a profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.|24 months|Study was discontinued prior to data being analyzed.||||||
2609226|NCT02068547|Primary|Rate of Fusion|Rate of fusion - (6, 12, and 24 months) Rate of fusion will be assessed by flexion extension X-rays at routine follow-up, translation method (<2mm) and/or by computed tomography (CT) scan at 2 year post-operatively.|6 months, 12 months, 24 months|Study was discontinued prior to data being analyzed.||||||
2609227|NCT02068508|Secondary|Number of Participants Who Received Specific Daily Dose of Insulin Product at Each Time Points|Number of participants who received study drug and specific daily dose of insulin product during the survey was reported. Daily dose of insulin was categorized by < 30 units, >= 30 and < 60 units, >= 60 and < 90 units, >= 90 units at each time points.|Baseline, Week 52, and final assessment (up to Week 52)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here number of participants analyzed was evaluable for this outcome measure.|||Participants|||Count of Participants
2609262|NCT02067728|Secondary|BMI Z-score Change for Ages 4-10 Years||Baseline and 6 months post encounter||||BMI z-score||Standard Deviation|Mean
2609233|NCT02068508|Primary|Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)|ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Up to Week 52|The safety analysis set was defined as all participants who were enrolled and completed the study.|||Participants|||Count of Participants
2609234|NCT02068495|Secondary|Percentage of Participants Who Meet Targeted Blood Pressure Level at Baseline and Final Assessment|Reported data are percentage of participants who meet targeted blood pressure level at baseline and final assessment in analysis population. Targeted blood pressure level of SBP/DBP was less than 140/90 mmHg.|Baseline and final assessment (up to 12 Months)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given time point.|||Percentage of Participants|||Number
2609235|NCT02068495|Secondary|Changes From Baseline in Pulse Rate at Final Assessment|Reported data are changes in Pulse Rate from baseline at final assessment (up to 12 months).|Baseline and final assessment (up to 12 Months)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given populations.|||Beats per minute||Standard Deviation|Mean
2609236|NCT02068495|Secondary|Changes From Baseline in Diastolic Blood Pressure (DBP) at Final Assessment|Reported data are changes in DBP from baseline at final assessment (up to 12 months).|Baseline and final assessment (up to 12 Months)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given populations.|||mmHg||Standard Deviation|Mean
2609237|NCT02068495|Secondary|Changes From Baseline in Systolic Blood Pressure (SBP) at Final Assessment|Reported data are changes in SBP from baseline at final assessment (up to 12 months).|Baseline and final assessment (up to 12 Months)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. Here 'Number of Participants Analyzed' is number of participants analyzed at the given populations.|||mmHg||Standard Deviation|Mean
2609238|NCT02068495|Primary|Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)|ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Up to 12 Months|The safety analysis set was defined as all participants who were enrolled and completed the study.|||Participants|||Count of Participants
2609239|NCT02068495|Primary|Number of Participants Who Experience at Least One Adverse Events||Up to 12 Months|The safety analysis set was defined as all participants who were enrolled and completed the study.|||Participants|||Count of Participants
2609240|NCT02068443|Secondary|Number of Participants Who Had Clinically Relevant Changes in 12-Lead Electrocardiogram (ECG) Findings|"Number of participants who had ECG findings changed from normal or abnormal but not clinically relevant at Baseline to abnormal and clinically relevant."|Baseline and Weeks 12 and 24|"Safety Analysis Set, all participants who received at least 1 dose of study drug, with ECG values normal or abnormal not clinically significant at Baseline."|||participants|||Number
2609241|NCT02068443|Secondary|Percentage of Participants With TEAEs Related to Vital Signs|Vital signs included sitting systolic and diastolic blood pressures (mmHg) (measured after resting for ≥ 5 minutes) and pulse rate (beats per minute [bpm]).|24 Weeks|Safety Analysis Set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2609242|NCT02068443|Secondary|Percentage of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis|The percentage of participants with any clinically relevant safety laboratory changes (chemistry, hematology and urinalysis) collected throughout study and recorded as AEs.|24 Weeks|Safety Analysis Set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2609243|NCT02068443|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|24 Weeks|Safety Analysis Set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2609244|NCT02068443|Secondary|Fasting Blood Glucose|The value of the fasting plasma glucose collected at Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.|||mg/dL||Standard Deviation|Mean
2609245|NCT02068443|Secondary|Change From Baseline in Fasting Blood Glucose|The change in the value of the fasting plasma glucose collected at Weeks 2, 4, 8, 12, 16, 20 and 24 relative to Baseline. A negative change from Baseline indicates improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.|||mg/dL||Standard Deviation|Mean
2609246|NCT02068443|Secondary|Percentage of Participants Achieving Target HbA1c (NGSP) Levels at the EOT Period|HbA1c (NGSP) is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound. The percentage of participants with HbA1c levels of ≥6.0, ≥7.0 and ≥8.0 at the end of Screening (Baseline) with change to target values <6.0, <7.0 and <8.0 respectively at EOT.|Baseline and EOT (Up to Week 24)|FAS included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2609247|NCT02068443|Secondary|HbA1c (NGSP)|The value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and EOT.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.|||percent||Standard Deviation|Mean
2609248|NCT02068443|Secondary|Change From Baseline in HbA1c (NGSP)|The change in the value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Weeks 2, 4, 8, 12, 16, 20, 24, and EOT relative to Baseline. A negative change from Baseline indicates improvement.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24 and EOT (Up to Week 24)|FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.|||percent||Standard Deviation|Mean
2609249|NCT02068443|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) National Glycohemoglobin Standardization Program (NGSP) at the End of Treatment (EOT) Period|The change in the value of HbA1c (NGSP) (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at End of Treatment Period relative to Baseline. A negative change from Baseline indicates improvement. An Analysis of Covariate (ANCOVA) model with change from Baseline as a dependent variable and Baseline and treatment as independent variables was used for main analyses.|Baseline and End of Treatment (EOT) (Up to Week 24)|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug.|||percent||Standard Error|Least Squares Mean
2609250|NCT02068222|Secondary|The Percentage of Subjects With Post-Treatment Relapse|Percentage of subjects with confirmed quantifiable HCV RNA within 12 weeks of last dose among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment.|Within 12 weeks after the last dose of study drug||||percentage of participants||95% Confidence Interval|Number
2609251|NCT02068222|Secondary|The Percentage of Subjects With Virologic Failure During Treatment|Percentage of subjects with quantifiable HCV RNA throughout the entire treatment period, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA during treatment.|Up to Treatment Week 12||||percentage of participants||95% Confidence Interval|Number
2609252|NCT02068222|Secondary|The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24)|SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug.|24 weeks after last dose of study drug||||percentage of participants||95% Confidence Interval|Number
2609253|NCT02068222|Primary|The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)|SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.|12 weeks after last dose of study drug||||percentage of participants||95% Confidence Interval|Number
2609254|NCT02068157|Secondary|Serum Alkaline DNase (SADA) Activity|SADA activity will be correlated with tumor response according to the guidelines of the revised Response Criteria in Solid Tumors 1.1.|Up to 12 months|The published assay could not be validated in murine samples. As such, no human samples were analyzed.||||||
2609255|NCT02068157|Primary|Percentage of Participants With Complete Response or Partial Response According to RECIST v1.1|Tumor response rate according to Response Evaluation Criteria in Solid Tumors 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 12 months|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2609256|NCT02068027|Secondary|Mean Daily Worst Pain Intensity Numeric Pain Rating Scale Scores|"The Numeric Pain Rating Scale is a single reading that measures the patients interpretation of their pain on a scale from 0, no pain to 10, worst pain imaginable. The change from baseline can range from -10 to 10. The change from Baseline (worst score from Day -14 to Day -8) to End-of-Treatment (worst score during Days 78 to 84 [±3 days]) in the Numeric Pain Rating Scale score assessing the worst pain in the past 24 hours in the painful areas of the feet from Days 78 to 84 compared to the 7 days at the Baseline Phase (Days -14 to -8). For the endpoint, the change in worst pain intensity from Baseline to Week 12 was analyzed using an analysis of covariance (ANCOVA) model with the Baseline worst pain intensity score serving as a covariate. The statistical model also included treatment, site, site by treatment interaction, and strata. If the site by treatment interaction term was not significant at the 0.1 level, then it was excluded from the model."|The change from Baseline (worse over Day -14 to Day -8) to End-of-Treatment (worse over Days 78 to 84 [±3 days])||||units on a scale||Standard Deviation|Mean
2609257|NCT02068027|Primary|Change From Baseline to Day 84 (Week 12) in Numeric Pain Rating Scale Score|"The Numeric Pain Rating Scale is a single reading that measures the patients interpretation of their pain on a scale from 0, no pain to 10, worst pain imaginable. The change from baseline can range from -10 to 10. The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days]) in the Numeric Pain Rating Scale score assessing the average pain in the past 24 hours in the painful areas of the feet averaged over Days 78 to 84 compared to the 7 days at the Baseline Phase (Days -14 to -8). For the primary efficacy endpoint, the mean change in pain intensity from Baseline to Week 12 was analyzed using an analysis of covariance (ANCOVA) model with the Baseline pain intensity score serving as a covariate. The statistical model also included treatment, site, site by treatment interaction, and strata. If the site by treatment interaction term was not significant at the 0.1 level, then it was excluded from the model."|The change from Baseline (averaged over Day -14 to Day -8) to End-of-Treatment (averaged over Days 78 to 84 [±3 days])||||units on a scale||Standard Deviation|Mean
2609258|NCT02067858|Other Pre-specified|Correlation of Imaging Response With Serum Protein and Peptide Profiles|Research blood draws looking at imaging repsonse before and after radiation in relationship to serum protein and peptide profiles|2 years|Blood draw samples were not drawn nor analyzed for this study||||||
2609259|NCT02067858|Secondary|Assess Progression-free Survival|Number of patients with Progression Free Survival at 2 Years|2 years||||Participants|||Count of Participants
2609260|NCT02067858|Primary|Assess Clinical Response Rate and Local Control Following SBRT Treatment of Patients With Early Stage NSCLC|The Number of Patients that completed SBRT|2 years||||Participants|||Count of Participants
2609261|NCT02067728|Secondary|BMI Z-score Change for Ages 11-17 Years||Baseline and 6 months post encounter||||BMI z-score||Standard Deviation|Mean
2609263|NCT02067728|Secondary|Success of Other Health Goals|Degree to which other health behavior goals (non-obesiogenic) were set and carried out at 6 months post encounter. Success defined as response of 2-4 on health behaviors survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.|6 months post encounter|This analysis population only includes subjects who set a health goal, which was not obesiogenic focused, during the initial visit and responded to the survey regarding success of achieving the goal 6 months post encounter.|||percentage of participants|||Number
2609264|NCT02067728|Secondary|Success of Other Health Goals|Degree to which other health behavior goals (non-obesiogenic) were set and carried out at 1 month post encounter. Success defined as response of 2-4 on health behaviors survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.|1 month post encounter|This analysis population only includes subjects who set a health goal, which was not obesiogenic focused, during the initial visit and responded to the survey regarding success of achieving the goal 1 month post encounter.|||percentage of participants|||Number
2609265|NCT02067728|Secondary|Success of Obesiogenic Goals|Degree to which an obesiogenic goal was set and successfully carried out at 6 months post encounter. Success is defined as rating of 3 or 4 on the 1 month health behavior survey, with 3=goal met most of the time and 4= goal met almost always.|6 months post encounter|This analysis population only includes those participants who initially set an obesiogenic focused goal at their well child check and then responded to the survey 6 months after to rate their success level in achieving that goal.|||percentage of participants|||Number
2609266|NCT02067728|Secondary|Success of Obesiogenic Goals|Degree to which an obesiogenic goal was set and successfully carried out at 1 month post encounter. Success is defined as rating of 3 or 4 on the 1 month health behavior survey, with 3=goal met most of the time and 4= goal met almost always.|1 month post encounter|This analysis population only includes the subjects who had initially set an obesiogenic goal at the well child appointment and responded to the survey at 1 month after the medical encounter to rate their level of success in achieving that goal.|||percentage of participants|||Number
2609267|NCT02067728|Secondary|Obesiogenic Goal Setting Success|Degree to which an obesiogenic goal was set and carried out at 6 months after the encounter. Success defined as response of 2-4 on survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.|6 months after encounter|This analysis population only includes the subjects who had initially set an obesiogenic goal at the well child appointment and responded to the survey at 6 months after the medical encounter when goal was set.|||percentage of participants|||Number
2609268|NCT02067728|Other Pre-specified|Obesity Follow-up Adherence|Subjects identified as obese with recommended follow-up appointment who are adherent to recommendation within 6 months of encounter|6 months after the encounter|This analysis population only includes the subjects who were identified as obese at their initial appointment and had a 6 month follow up appointment scheduled at that time.|||percentage of participants|||Number
2609269|NCT02067728|Other Pre-specified|Perception of Patient Centeredness of Encounter|Patient centeredness survey which measures the parent's and patient's (if 12 years and older) perception of how patient centered the communication was with the provider. Survey Coding for Patient Centeredness: 1=Not at all; 2=A little; 2.5=Can't say; 3=Somewhat; 4=A lot|1 month after the encounter||||units on a scale||Standard Deviation|Mean
2609270|NCT02067728|Other Pre-specified|BMI Z-score Change for All|Anthropometric measures of weight and height and calculated BMI z score change at 6 months post encounter.|Baseline and 6 months after the encounter|The number of participants analyzed is low because returning for measurement checks was optional at 6 months & only 28% usual care and 27% intervention group attended. We also included chart abstraction measurements for those who had a return clinic visit with measurements within 6 months +/- 2 months from initial encounter.|||BMI z-score||Standard Deviation|Mean
2609271|NCT02067728|Secondary|Obesiogenic Goal Setting Success|Degree to which an obesiogenic goal was set and carried out at 1 month after the encounter. Success defined as response of 2-4 on health behaviors survey, with 2=success some of the time, 3=success most of the time, and 4=success almost always.|1 month after the encounter|This analysis population only includes the participants who set an obesiogenic goal at the initial appointment and completed the 1 month post survey to rate their success level in achieving that goal.|||percentage of participants|||Number
2609272|NCT02067728|Primary|Percentage of Patients With Documented Goal Setting|Health behavior change goal documented in charting of well-child visits.|2 weeks from encounter|Manual chart review of the electronic medical record (EMR) was completed by the Research Team for all enrolled subjects in both study groups. Goal documentation was defined as any type of goal consisting of an active verb written either on the FNPA Tool which was completed during the well child visit or in Physician notes in the EMR for the visit.|||percentage of participant charts|||Number
2609273|NCT02067676|Secondary|Interferon Titers Among All Cohorts|CRM197-specific interferon-y (IFNy) responses measured from PBMC on day0, 28 and 56|Day 0, 28 and 56||||GMTs||95% Confidence Interval|Geometric Mean
2609274|NCT02067676|Secondary|Vaccine-specific Anti-CRM^197 IgA Antibody-secreting Cell (ASC) Responses|"Anti-CRM^197 IgG ASC Responses - GMTs with 95% CI.~A positive immunoglobulin A (IgA)-ASC response will be defined as a > twofold increase over the baseline value of the ASCs per 10^6 peripheral blood mononuclear cells (PBMCs). A subject will be considered a responder if the post-vaccination value is greater than 2.0 per 10^6 PBMCs. Blood samples will also be utilized to explore in vitro production of interferon (IFN)-(gamma)."|Study Days 0-56||||GMTs||95% Confidence Interval|Geometric Mean
2609275|NCT02067676|Secondary|Vaccine-specific Geometric Mean Titers (GMT) of Anti-CPS IgG Antibody-secreting Cells|"Anti-CPS IgG ASC Responses - GMTs with 95% CI.~A positive immunoglobulin A (IgA)-ASC response will be defined as a > twofold increase over the baseline value of the ASCs per 10^6 peripheral blood mononuclear cells (PBMCs). A subject will be considered a responder if the post-vaccination value is greater than 2.0 per 10^6 PBMCs. Blood samples will also be utilized to explore in vitro production of interferon (IFN)-(gamma)."|Study Days 0-56||||GMTs||95% Confidence Interval|Geometric Mean
2609291|NCT02067611|Other Pre-specified|Subject's Global Assessment of Disease Status of the Target Knee at 2, 4, 8 and 12 Weeks of Treatment|"Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|at 2, 4, 8, and 12 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
2609276|NCT02067676|Secondary|Frequency (%) of Vaccine-specific Immune Responses by Assay and Antigen Using Enzyme-linked Immunosorbent Assay (ELISA)|"Primary immunologic parameters, serum samples were assessed for the antibody titers against Campylobacter jejuni conjugate vaccine1 (CJCV1) using ELISA (enzyme-linked immunosorbent assay) based methods.~Antibody-secreting cell(s) (ASCs): >0.5 per 10(6) Peripheral blood mononuclear cell (PBMCs) in the baseline sample. When the number of baseline ASCs is less than 0.5 per 10(6) PBMCs, a subject was considered a responder if the post-vaccination value was greater than 1.0 per 10(6) PBMCs. ((6) is superscript).~= Seroconversion was defined as >4fold increase in endpoint titer between pre- and post-vaccine samples and a post-vaccine reciprocal titer >10.~= Response is defined as a >2fold increase over the baseline value of ASC per 10(6) PBMCs, when the number of ASCs is >0.5 per 10(6) PBMCs in the baseline sample. When the number of baseline ASCs is less than 0.5 per 10(6) PBMCs, a subject was considered a responder if the post-vaccine value was greater than 1.0 per 10(6) PBMCs."|Study Days 0-56|Campylobacter jejuni conjugate vaccine (1CJCV1); antibody-secreting cell(s) (ASCs); Peripheral blood mononuclear cell (PBMCs)|||% of immune response|||Number
2609277|NCT02067676|Primary|Safety: Presence of Related/Not Related Local and/or Systemic Reactogenicity (Adverse Events)|Vaccine safety will be assessed by evaluating post-vaccination local and systemic reactions through targeted physical exams, symptom surveys, and other adverse event (AE) monitoring. All subjects will be observed in the clinic for at least 30 minutes after receipt of the investigational product. Approximately 48 hours after vaccination, subjects will return to the Clinical Trials Center for observation and reporting of any local and/or systemic AEs. Seven days after vaccine administration, subjects will return to the Clinical Trials Center to review their memory aids with study personnel and to report any AEs. In addition to planned visits, if a subject experiences any unanticipated AE, the subject will be seen by one of the study investigators. All AEs will be coded for onset date, duration, severity, and potential relationship to the investigational product.|up to 7 days|Rates of all AEs were analyzed by Pearson’s Chi-square test (or Fisher’s exact test if assumptions were not met for Pearson’s Chi-square) to compare groups.|||Adverse Events|||Number
2609278|NCT02067663|Secondary|Intrauterine Device Expulsion by 12 Weeks Postpartum|Position of the IUD within the uterus will be documented by ultrasound.|12 weeks||||Participants|||Count of Participants
2609279|NCT02067663|Secondary|Intrauterine Device Expulsion (6 Weeks)|Number of expulsions. Position of the IUD within the uterus will be documented by ultrasound.|6 weeks||||participants|||Number
2609280|NCT02067663|Secondary|Intrauterine Device Expulsion (Day 1)|Number of expulsions at Day 1. Position of the IUD within the uterus will be documented by ultrasound.|Day 1||||participants|||Number
2609281|NCT02067663|Secondary|Satisfaction|A questionnaire will be administered to determine the participant's satisfaction level with the IUD. Satisfaction levels of >= 8 are reported by percent of participants.|3 months||||percent of participants|||Number
2609282|NCT02067663|Secondary|Complications|A questionnaire will be administered to determine if the participant has had any complications since placement. Number of women reporting complications are reported.|3 months||||Participants|||Count of Participants
2609283|NCT02067663|Secondary|Pregnancy|A urine pregnancy test will be performed at the 3 month follow up visit if clinically indicated.|3 months||||Participants|||Count of Participants
2609284|NCT02067663|Secondary|Pregnancy|A urine pregnancy test will be performed at the 6 week follow up visit if clinically indicated.|6 weeks||||Participants|||Count of Participants
2609285|NCT02067663|Primary|IUD Expulsion Rate|The primary outcome of the study is the total number of expulsions in the full 3 month study period. The provider will perform a speculum exam and transvaginal ultrasound. If expulsion has occurred, the participant will have an abdominal x-ray to confirm.|3 months postpartum||||Participants|||Count of Participants
2609286|NCT02067611|Other Pre-specified|Amount of Rescue Medication (Acetaminophen) Consumed Per Day for Target Knee Pain.|"Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|at 2, 4, 8, and 12 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
2609287|NCT02067611|Other Pre-specified|Change From Baseline Over Time in VAS Pain Scores for the Target Knee From Daily Diary Data.|"Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|at 2, 4, 8, and 12 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
2609288|NCT02067611|Other Pre-specified|Investigator's Global Assessment of Response to Therapy of the Target Knee at 2, 4, 8 and 12 Weeks of Treatment|"Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|at 2, 4, 8, and 12 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
2609289|NCT02067611|Other Pre-specified|Subject's Global Assessment of Response to Therapy of the Target Knee at 2, 4, 8 and 12 Weeks of Treatment|"Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|at 2, 4, 8, and 12 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
2609290|NCT02067611|Other Pre-specified|Investigator's Global Assessment of Disease Status of the Target Knee at 2, 4, 8 and 12 Weeks of Treatment|"Data for the exploratory efficacy endpoints will be summarized using descriptive statistics.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|at 2, 4, 8, and 12 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
2609292|NCT02067611|Secondary|Characterize the Pharmacokinetics of X0002|Cmax, Tmax, AUCs, apparent terminal elimination rate constant, apparent terminal elimination half-life will be calculated.|at the Week 2, week 3, week 4 and Week 12|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
2609293|NCT02067611|Secondary|To Assess the Effect of X0002 Spray Compared to Placebo on Difficulty Performing Daily Activities|"A sensitivity analysis will also be conducted on the Primary Efficacy Endpoint using an ANCOVA with treatment as a fixed class effect and WOMAC baseline pain subscale score as covariates, but the comparisons of interest will be the difference between the active and placebo subjects within each treatment group.~The Secondary Efficacy Endpoints, change from Baseline in the WOMAC subscale scores for pain, stiffness, and functional ability, and overall WOMAC score at 2, 8, and 12 weeks of treatment, will be by analyzed using the same methods as the for the Primary Efficacy Endpoint.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|at 2, 4, 8, and 12 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
2609294|NCT02067611|Secondary|To Evaluate the Effect of X0002 Spray Compared to Placebo for the Relief of Joint Stiffness|"A sensitivity analysis will also be conducted on the Primary Efficacy Endpoint using an ANCOVA with treatment as a fixed class effect and WOMAC baseline pain subscale score as covariates, but the comparisons of interest will be the difference between the active and placebo subjects within each treatment group.~The Secondary Efficacy Endpoints, change from Baseline in the WOMAC subscale scores for pain, stiffness, and functional ability, and overall WOMAC score at 2, 4, 8, and 12 weeks of treatment, will be by analyzed using the same methods as the for the Primary Efficacy Endpoint.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|2, 4, 8, and 12 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
2609295|NCT02067611|Secondary|To Assess the Safety and Tolerability of Multiple Doses of X0002 When Administered as a Topical Spray|"A sensitivity analysis will also be conducted on the Primary Efficacy Endpoint using an ANCOVA with treatment as a fixed class effect and WOMAC baseline pain subscale score as covariates, but the comparisons of interest will be the difference between the active and placebo subjects within each treatment group.~The Secondary Efficacy Endpoints, change from Baseline in the WOMAC subscale scores for pain, stiffness, and functional ability, and overall WOMAC score at 2, 8, and 12 weeks of treatment, will be by analyzed using the same methods as the for the Primary Efficacy Endpoint.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|2, 8, and 12 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
2609296|NCT02067611|Primary|To Evaluate the Efficacy of X0002 Spray Compared to Placebo for Relief of Knee Pain in Subjects With Osteoarthritis (OA) of the Knee|"The Primary Efficacy Endpoint is change from Baseline in the WOMAC (VAS) pain subscale score for the target knee at 4 weeks of treatment, and will be analyzed using an analysis of covariance (ANCOVA). Treatment will be included as a fixed class effect and WOMAC Baseline pain subscale score as covariates. The primary comparisons of interest will be the difference between active Group A (low dose) and combined placebo, active Group B (middle dose) and combined placebo, and active Group C (high dose) and combined placebo.~Safety analyses will be conducted on the SAS. Safety parameters will be listed and summarized using standard descriptive statistics, as appropriate. No formal statistical analyses are planned."|4 weeks of treatment|The labels for X0002 and placebo were mixed up, and the data was mixed up totally.||||||
2609297|NCT02067585|Secondary|Glucose||6 hours||||mmol/L||Standard Deviation|Mean
2609298|NCT02067585|Secondary|Glucose||4 hours||||mmol/L||Standard Deviation|Mean
2609299|NCT02067585|Secondary|Glucose||90 minutes||||mmol/L||Standard Deviation|Mean
2609300|NCT02067585|Secondary|Glucose||30 minutes||||mmol/L||Standard Deviation|Mean
2609301|NCT02067585|Secondary|Blood Glucose||0 minute||||mmol/L||Standard Deviation|Mean
2609302|NCT02067585|Primary|Triglyceride||6 hours||||mmol/L||Standard Deviation|Mean
2609303|NCT02067585|Primary|Triglyceride||4 hours||||mmol/L||Standard Deviation|Mean
2609304|NCT02067585|Primary|Triglyceride||90 minutes||||mmol/L||Standard Deviation|Mean
2609305|NCT02067585|Primary|Triglycerides||30 minutes||||mmol/L||Standard Deviation|Mean
2609306|NCT02067585|Primary|Triglycerides Post-prandial||0 minutes||||mmol/L||Standard Deviation|Mean
2609307|NCT02067533|Primary|Knee Range of Motion (ROM)|in all patients ROM is measure 1 year after knee surgery by one of the study investigator using goniometer.|1 year after total knee arthroplasty||||degree||Standard Deviation|Mean
2609308|NCT02067468|Secondary|Concerns About Fertility, Cancer, and Gynecological Health|This outcome was measured using the HPV Impact Profile (HIP) scale through the following five domains: concerns about cancer and loss of fertility; emotional impact (depression and anxiety); self-image; interaction with the medical staff (pain or discomfort during the visit); and impact upon the life and its control. The response to each domain was measured on a scale from 0 to 10 (0=not at all, 1-3=a little, 4-6=somewhat, 7-9=a great deal, 10=extremely) and was then transformed to a scale from 0 to 100. A total score was calculated by adding all the items. Values <40 indicate no or little impact, between 40 and 70 moderate impact, and >70 indicate high psychosocial impact. This outcome was measured at the enrollment visit, between two weeks and two months after receiving the triage result, and after one year of receiving the triage result.|Two years between the enrolment and the exit visit|This is a nested analysis that included 394 subjects of the ASCUS-COL trial (142 in COLPOSCOPY, 103 in CYTOLOGY, and 149 HPV) who accepted to participate and completed the follow-up of three measurements over time.|||score on a scale||Standard Deviation|Mean
2609309|NCT02067468|Secondary|State Anxiety|State anxiety refers to the transitory tendency to experience negative emotions (such as fears, worries, and anxiety). This outcome was measured using the Spielberger State-Trait-Anxiety Inventory (STAI) through 20 Likert-type questions with scores varying between 0 and 3 (0=not at all, 1=somewhat, 2=moderately, 3=very much). Total values range between 0 and 60 where higher scores suggest higher levels of anxiety. This outcome was measured at the enrollment visit, between two weeks and two months after receiving the triage result, and after one year of receiving the triage result.|Two years between the enrolment and the exit visit|This is a nested analysis that included 394 subjects of the ASCUS-COL trial (142 in COLPOSCOPY, 103 in CYTOLOGY, and 149 HPV) who accepted to participate and completed the follow-up of three measurements over time.|||score on a scale||Standard Deviation|Mean
2609310|NCT02067468|Secondary|Trait Anxiety|Trait anxiety refers to the sustainable tendency to experience negative emotions (such as fears, worries, and anxiety) in various situations. This outcome was measured using the Spielberger State-Trait-Anxiety Inventory (STAI) through 20 Likert-type questions with scores varying between 0 and 3 (0=not at all, 1=somewhat, 2=moderately, 3=very much). Total values range between 0 and 60 where higher scores suggest higher levels of anxiety. This outcome was measured at the enrollment visit, between two weeks and two months after receiving the triage result, and after one year of receiving the triage result.|Two years between the enrolment and the exit visit|This is a nested analysis that included 394 subjects of the ASCUS-COL trial (142 in COLPOSCOPY, 103 in CYTOLOGY, and 149 HPV) who accepted to participate and completed the follow-up of three measurements over time.|||score on a scale||Standard Deviation|Mean
2609311|NCT02067468|Secondary|Self-esteem|Self-esteem corresponds to the self-assessment of a positive or negative evaluation toward oneself. This outcome was measured using the Rosenberg Scale through 10 Likert-type questions with scores varying between 1 and 4 (1=strongly agree, 2=agree, 3=disagree, 4=strongly disagree). Total values range between 10 and 40 where lower scores suggest lower self-esteem. This outcome was measured at the enrollment visit, between two weeks and two months after receiving the triage result, and after one year of receiving the triage result.|Two years between the enrolment and the exit visit|This is a nested analysis that included 394 subjects of the ASCUS-COL trial (142 in COLPOSCOPY, 103 in CYTOLOGY, and 149 HPV) who accepted to participate and completed the follow-up of three measurements over time.|||score on a scale||Standard Deviation|Mean
2609312|NCT02067468|Secondary|"Number of Clinical Records (Cytologies, Colposcopies, and Histologies): Health Care Utilization"|The outcome is defined as the number of cytologies, colposcopies, and histologies routinely performed during the two years of follow-up. Records were identified in databases or manually searched from clinical records. This outcome will be used for the analysis of the efficiency of the three strategies.|Two years since the enrolment to before the exit visit (i.e., excluding clinical records collected at the exit visit)|Utilization of cytology, colposcopy and histology during the routine follow-up of women with ASC-US cytology stratified by arm|||Clinical records|||Number
2609313|NCT02067468|Secondary|"Number of Participants Diagnosed by a Panel of External Experts With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+) at the Exit Visit, Two Years After the Enrolment: Exit-reviewed CIN2+"|Cervical Intraepithelial Neoplasia Grade 2 or higher (CIN2+) diagnosed by a panel of external experts after reviewing biopsies collected at the exit visit, two years after the enrolment. This outcome is an estimate of the remaining disease that was not detected by the strategies during the 2 years of follow-up. The outcome was obtained after the review of all the biopsies taken during the exit visit. Biopsies were taken using a standardized research protocol to ensure the completeness of the remaining disease. Basically, all women attending the exit visit were tested with HPV testing and Pap and referred to colposcopy if any HPV positive or abnormal cytology. The colposcopy was performed by a researcher of the study team who took up to two biopsies from the observed lesion plus one or two at random if none lesion was observed. All biopsies were reviewed by the external panel. This outcome is used for the efficiency analysis of the three strategies.|Exit visit (two years after the enrolment)|Exit-reviewed CIN2+ detected at the exit visit (2 years after the enrolment) of women with ASC-US cytology stratified by arm|||Participants|||Count of Participants
2609314|NCT02067468|Secondary|"Cumulative Number of Participants Diagnosed by a Panel of External Experts With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): Reviewed CIN2+"|Cumulative Cervical Intraepithelial Neoplasia Grade 2 or higher (CIN2+) diagnosed by a panel of external experts obtained after histological review of biopsies emitted by the community pathologists. Biopsies obtained during the two years of follow-up and the exit visit were reviewed by a panel of two external experts and a final result was adjudicated to each participant based on the panel of experts and the community of pathologists. This outcome is used for the effectiveness analysis of the three strategies.|Two years since the enrolment to the exit visit (inclusive)|Cumulative cases of CIN2+ diagnosed by a panel of external expert pathologists according to arm|||Participants|||Count of Participants
2609315|NCT02067468|Primary|"Cumulative Number of Participants Diagnosed by the Community Pathologist With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): Community-based CIN2+"|Cumulative Cervical Intraepithelial Neoplasia Grade 2 or higher (CIN2+) diagnosed by the community pathologists during the two years of follow-up. The first community-based CIN2+ diagnosis was adjudicated to the participant (including the exit visit if none community-based CIN2+ during the two years of follow-up). This outcome is used for the effectiveness analysis of the three strategies.|Two years since the enrolment to the exit visit (inclusive)|Cumulative cases of CIN2+ diagnosed by the community pathologists from the healthcare institutions according to arm|||Participants|||Count of Participants
2609316|NCT02067273|Primary|Present Pain Intensity|Present pain intensity was reported by participants using a visual analog scale (VAS) from scores ranging from 1-10; lower scores represent less pain, higher scores represent more severe pain.|Baseline, post-treatment, one week follow-up|Data from participants who completed the study were analyzed.|||Units on a scale||Standard Deviation|Mean
2609317|NCT02067104|Secondary|The Incidence of Newly Diagnosed Squamous Cell Carcinomas (SCC) in the Same Subjects Receiving Vismodegib Treatment When Compared With Placebo|Measured by the incidence of biopsy confirmed SCC over the same 24 month period|24 Months|Early study termination due to low accrual. No data analyzed; no results.||||||
2609318|NCT02067104|Primary|The Effect of Vismodegib Pulse Therapy on the Incidence of Newly Diagnosed Basal Cell Carcinomas (BCC)|Measured by the incidence of biopsy confirmed BCC over a 24 month period|24 Months|Early study termination due to low accrual. No data analyzed; no results.||||||
2609319|NCT02067039|Secondary|HIV Infections Among Social Network Associates|Number of social network associates (N=2150)who received a study self-test from ST participants (N=1325) and who reported a positive HIV self-test result. Sample size for this analyses is 2150.|12 months|Number of social network associates who used a study HIV self-test and received a new HIV diagnosis|||social network members|||Number
2609320|NCT02067039|Secondary|Newly Identified HIV Infections|Report of positive HIV test result (self-test or provider testing)|12 months|All persons assigned to study.|||Participants|||Count of Participants
2609321|NCT02067039|Secondary|Linkage to HIV Testing and Care Services Following a Positive Rapid Test Result.|MSM who report accessing supplemental testing and care following a positive rapid HIV test results.|12 months|Persons who reported initiating linkage to care following an HIV positive test|||Participants|||Count of Participants
2609323|NCT02066922|Secondary|Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1|Subjective manifest refraction was assessed using a phoropter or trial frame set with the subject's current prescription at Baseline (Visit 2) after a 2-day washout period and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Spectacle over-refraction, if required, was performed. Higher myopia is indicated by larger negative values in manifest refraction.|Baseline, Week 1 (Day 8 of lens wear)|This analysis group includes all randomized participants with data present at visit.|||Eyes|||Number
2609324|NCT02066922|Primary|Change in Average Central Corneal Curvature From Dispense at Week 1|Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening.|Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear)|This analysis group includes all randomized participants with data present at visit.|||diopters||Standard Deviation|Mean
2609325|NCT02066896|Secondary|Salivary Flux Measurement|"The salivary flux was measured at the same time, without previous meal or tooth brushing, drinking or eating, in a quiet room. Spilled saliva was collected in a graduated Falcon 15ml tube. The samples of saliva were frozen and stored at -20° C.~Normal salivary stimulated flux is above 0,5 ml/min. Normal unstimulated salivary flux is above 0,2 ml/min."|6 weeks||||ml/min||Standard Deviation|Median
2609326|NCT02066896|Secondary|Salivary Biomarker Analysis. Beta 2 Microglobulin.|"The saliva in Sögren`s syndrome patients has a high level of beta 2 microglobulin reflecting progression of the disease and inflammatory process at glandular epithelium.~The saliva samples were collected at the baseline and end point. Beta 2 microglobulin was determined by Elisa human kit (ABCAM ab 108885).~The normal levels are 1,2 +/- 0,7 microg/ml, and for primary Sjögren`s syndrome 5,3 +/- 4,6 microg/ml.~This measure was done in the samples of saliva before and after the lasertherapy for all patients."|6 weeks||||microg/ml||Standard Deviation|Median
2609327|NCT02066896|Primary|The Xerostomia Inventory|"The Xerostomia Inventory (XI) is an 11-item questionnaire (Thomson et al, 1999). Scores to the 11 items are summated, providing a single score (5-55) representing the subjective severity of xerostomia. In 2012, da Mata published a validated version in portuguese and we used this version. The better score is the lowest. The significant variation is defined as 6 or more.~Bellow we describe all the 11 questions:~I sip liquids to aid in swallowing food~My mouth feels dry when eating a meal~I get up at night to drink~My mouth feels dry~I have difficulty in eating dry foods~I suck sweets or cough lollies to relieve dry mouth~I have difficulties swallowing certain foods~The skin of my face feels dry~My eyes feel dry~My lips feel dry~The inside of my nose feels dry __________________________________________________________~Score:~Never' (1), Hardly ever' (2), Occasionally' (3), Fairly often' (4), Very often' (5)"|6 weeks|Intent to treat population. Last observation carried forward imputation method.|||units on a scale||Standard Deviation|Mean
2609328|NCT02066857|Secondary|Change in SF-12 QOL|The SF-12 QOL is a self-administered measure asking views about participant's health and how well they are able to perform usual activities.|Baseline, Month 3|No participants completed this survey as this outcome measure was removed from the protocol. No data were collected.||||||
2609329|NCT02066857|Secondary|Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score|The DASH questionnaire asks about symptoms as well as ability to perform certain activities. Scores range on a 0-100 scale. A higher score indicates greater disability.|Baseline, Week 2, Week 6, Week 12|Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.|||units on a scale||Standard Deviation|Mean
2609330|NCT02066857|Primary|Mean Pain Score|"Pain will be assessed by a visual analog scale (VAS). Participants rate their pain level in a scale from 0 to 10; 0 representing no pain and 10 representing the worst pain imaginable. The assessment was completed at all study visits."|Baseline, Week 2, Week 6, Week 12|Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.|||units on a scale||Standard Deviation|Mean
2609331|NCT02066857|Primary|Complication Rate|The number of participants who experienced treatment related complications including the need for manipulation in the case of lost reduction.|Duration of Study (Up to 3 Months)|Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.|||Participants|||Count of Participants
2609332|NCT02066857|Primary|Change in Grip Strength|Grip strength will be assessed by bilateral dynamometer testing.|Baseline, Month 3|Data for this outcome measure are not available for analysis.||||||
2609333|NCT02066857|Primary|Mean Mayo Wrist Score|The Mayo Wrist Score is a clinician-completed scoring system used to evaluate the level of functionality in the wrist, assessing pain, functional status (able to work), range of motion and grip strength. Total scores for functionality range from 0-100 and are categorized as follows: 90-100 indicates excellent, 80-90 indicates good, 60-80 indicates satisfactory, below 60 indicates poor. The assessment was completed at all study visits.|Baseline, Week 2, Week 6, Week 12|Of the 5 participants who were enrolled, data were analyzed for the 3 participants who completed all study visits.|||units on a scale||Standard Deviation|Mean
2609334|NCT02066857|Primary|Change in Wrist Range of Motion (ROM)|Wrist ROM will be assessed by a goniometer exam.|Baseline, Month 3|Data for this outcome measure are not available for analysis.||||||
2609335|NCT02066740|Primary|Successful Stent Deployment|Successful stent deployment to be assessed based on stent delivery, lesion coverage and accuracy of deployment.|Procedure||||percentage - successful stent deployment|Stents Implanted||Number
2609336|NCT02066740|Primary|Absence of Stent Elongation|Absence of stent elongation is achieved when the implanted stent length does not exceed the allowed stent length|Intra operative||||percentage absence of stent elongation|Number of Stents Implanted||Number
2609337|NCT02066727|Secondary|Complication Related With Nerve Block|Complication related with nerve block is defined as the presence of either bradycardia, delayed recovery, persistent groin pain, neuropathy during operation and postoperatively|during operation, 0.5,24hour postoperatively|||||||
2609422|NCT02065453|Primary|The Primary Endpoint of This Study is Time Difference Between Cauterizing One Side of the Uterine Attachments, From the Round Ligament to the Uterine Artery on One Side, to the Time Detaching the Same Tissues on the Other Side|duration of surgery|Primary outcome study data is collected with the first incision and completed with skin closure at the completion of the surgery.|Uterine Vessel Desiccation and Electrosurgical Cutting Time (min)|||minutes||Full Range|Median
2609338|NCT02066727|Primary|Median Effective Concentration(EC50)|"Median effective concentration(EC50) was not calculated per-participants, the up-and-down sequential allocation method was used to determine the median effective concentration(EC50) of lidocaine, running the two groups in parallel. The concentration of lidocaine for the second and subsequent patients in each group were dictated by the response of the previous patient in the group, such that an effective block led to a decreased concentration of the next patient, an ineffective block led to an increased concentration.~For each group, we collected: the logarithm of lidocaine concentration, the number of effective block, ineffective block, total number of the patient, and successful rate. Then lgEC50 and slgEC50 was calculated as formulas. The logarithm of confidence intervals(95% CI) was calculated as lgEC50±1.96slgEC50. All of the calculation can be performed by SPSS19.0 for windows."|10min||||mg/ml(the concentration of lidocaine)||95% Confidence Interval|Number
2609339|NCT02066467|Other Pre-specified|3 Month Implant Success Rate for Indicated Subjects|"Post Market Clinical Follow-up (PMCF) of the ACUITY X4® lead was evaluated in this study. The outcome of interest is the 3 month implant success rate. The cohort of subjects included in this evaluation is the first 200 subjects to receive an ACUITY X4® lead implant and meet the PMCF eligibility criteria outlined below. The outcomes of interest for the PMCF supplemental analysis is the percent of subjects successfully implanted with an ACUITY X4® lead.~Implant success is defined as the ability of the ACUITY X4® lead to be implanted and deliver CRT therapy. Subjects who have multiple lead implant attempts during the procedure, but are eventually successfully implanted with the ACUITY X4® lead and receive CRT therapy are classified as a successful implant."|3 months post-implant|At data cutoff date on 16 November 2015, 201 enrolled subjects met all of the PMCF eligibility criteria and were included in the analysis.|||% of participants||90% Confidence Interval|Number
2609340|NCT02066467|Secondary|3 Month Lead-related Complication-Free Rate (CFR)|Lead-related Complication-Free Rate (CFR) from implant through 3 months post-implant. Lead-related complications associated with the ACUITY X4® lead were counted towards this endpoint.|3 months post-implant|795 patients successfully implanted with ACUITY X4 lead|||% of participants||90% Confidence Interval|Number
2609341|NCT02066467|Primary|Phrenic Nerve Complication Free Rate|The Phrenic Nerve Stimulation (PNS) related Complication Free rate (CFR) through 6 months post-implant is defined as the rate of freedom from loss of function or operative system revision due to unacceptable PNS threshold|6 months post-implant|795 patients successfully implanted with ACUITY X4 lead|||% of participants||90% Confidence Interval|Number
2609342|NCT02066415|Secondary|Number of Participants Who Developed Antibodies to Erenumab|"Blood samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against erenumab. Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based bioassay to determine neutralizing activity against erenumab (Neutralizing Antibody Assay).~Developing antibody incidence indicates participants with a negative or no result at baseline and a positive result at any time post-baseline.~If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies."|Baseline and weeks 2, 4, 8, 12 and 24|Randomized participants who received at least one dose of study drug and with available post-baseline antibody data. This endpoint was analyzed in the erenumab treatment groups only.|||Participants|||Count of Participants
2609343|NCT02066415|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4, where:~Grade 1 = Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 = Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 = Life-threatening consequences; urgent intervention indicated Grade 5 = Death related to AE."|From the first dose of study drug up to 16 weeks after the last dose (24 weeks)|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2609344|NCT02066415|Secondary|Change From Baseline in Cumulative Monthly Headache Hours|"The cumulative duration of any qualified headache between monthly doses of study drug regardless of acute treatment use.~A qualified headache was defined as follows:~a qualified migraine headache (including an aura-only event that is treated with acute migraine-specific medication), or~a qualified non-migraine headache, which is a headache that lasted continuously for ≥ 4 hours and was not a qualified migraine headache, or~a headache of any duration for which acute headache treatment was administered."|4-week baseline phase and the last 4 weeks of the 12-week treatment phase|"The efficacy analysis set included participants who received at least 1 dose of study drug and completed at least 1 post-baseline monthly eDiary measurement.~The number of participants analyzed includes those with observed data at week 12."|||hours / month||95% Confidence Interval|Least Squares Mean
2609345|NCT02066415|Secondary|Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days|Monthly acute migraine-specific medication treatment days is the number of days on which migraine specific medications were used between monthly doses of study drug. Migraine-specific medications includes two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications.|4-week baseline phase and the last 4 weeks of the 12-week treatment phase|"The efficacy analysis set included participants who received at least 1 dose of study drug and completed at least 1 post-baseline monthly eDiary measurement.~The number of participants analyzed includes those with observed data at week 12."|||acute migraine treatment days / month||95% Confidence Interval|Least Squares Mean
2609365|NCT02066389|Primary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12|"Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:~≥ 20% improvement in 68-tender joint count;~≥ 20% improvement in 66-swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High-sensitivity C-reactive protein (hsCRP)."|Baseline and Week 12|All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF) imputation was used for participants with missing data at Week 12 if prior post-baseline data were available.|||percentage of participants|||Number
2609346|NCT02066415|Secondary|Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Baseline|"A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the last 4 weeks of treatment.~At least a 50% reduction from baseline in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the last 4 weeks of the 12-week treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%."|4-week baseline phase and the last 4 weeks of the 12-week treatment phase|"The efficacy analysis set included participants who received at least 1 dose of study drug and completed at least 1 post-baseline monthly eDiary measurement.~Participants with missing post-baseline data were counted as non-responders."|||percentage of participants|||Number
2609347|NCT02066415|Primary|Change From Baseline in Monthly Migraine Days|"A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura.~The change from baseline in monthly migraine days was calculated as the number of migraine days during the last 4 weeks of the 12-week treatment phase - the number of migraine days during the 4-week baseline phase."|4-week baseline phase and the last 4 weeks of the 12-week treatment phase|The efficacy analysis set included participants who received at least 1 dose of study drug and completed at least 1 post-baseline monthly eDiary measurement. The number of participants analyzed includes those with observed data at week 12.|||migraine days / month||95% Confidence Interval|Least Squares Mean
2609348|NCT02066402|Secondary|Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point|The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value.|Up to EOT visit (Day 11)|ITT|||Units on a scale||Standard Deviation|Mean
2609349|NCT02066402|Secondary|Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point|The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value.|Up to EOT visit (Day 11)|ITT|||Units on a scale||Standard Deviation|Mean
2609350|NCT02066402|Secondary|Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point|The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value.|Up to EOT visit (Day 11)|ITT|||Units on a scale||Standard Deviation|Mean
2609351|NCT02066402|Secondary|Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point|The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value.|Up to EOT visit (Day 11)|ITT|||Units on a scale||Standard Deviation|Mean
2609352|NCT02066402|Secondary|Investigator's Assessment of Clinical Response at Day 7 Visit|The Investigator made an assessment of clinical response at Day 7 Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Other.|Baseline and Day 7 visit|ITT|||Percentage of participants|||Number
2609353|NCT02066402|Secondary|Investigator's Assessment of Clinical Response at 48-72 Hours|The Investigator made an assessment of clinical response at the 48-72 Hour Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Stable (Signs and symptoms stable, no apparent change in overall clinical status but compatible with continuation of study drug therapy); Other.|Baseline and at 48-72 hours|ITT|||Percentage of participants|||Number
2609354|NCT02066402|Secondary|Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the Clinically Evaluable at Post Therapy Evaluation (CE-PTE) Analysis Set|The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported.|Baseline and post-therapy evaluation visit (7-14 days after Day 11)|CE-PTE|||Percentage of participants|||Number
2609355|NCT02066402|Secondary|Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set|The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported.|Baseline and post-therapy evaluation visit (7-14 days after Day 11)|ITT|||Percentage of participants|||Number
2609356|NCT02066402|Secondary|Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set|Clinical response will be defined as percentage of participants with clinical success, clinical failure or indeterminate.|Baseline and EOT visit (Day 11)|CE-EOT|||Percentage of participants|||Number
2609366|NCT02066311|Primary|Inhibition of Anti-dsDNA Binding|Change in serum anti-dsDNA titer from baseline to Day 56; a decrease in titer ≥ 35% was considered a positive response|baseline to Day 56|The number of participants whose anti-dsDNA antibody titer decreased by ≥ 35% from baseline to Day 56|||Participants|||Count of Participants
2609367|NCT02066298|Secondary|Asthma Exacerbations|"Asthma exacerbations are more severe episodes of acute worsening, defined by meeting one or more of the following:~FEV1 <50% of baseline on 2 consecutive measurements~FEV1 <40% of predicted on 2 consecutive measurements~Use of ≥ 16 puffs of as needed β-agonist per 24 hours for a period of 48 hours~Use of oral/parenteral corticosteroid due to asthma"|End of 12-week treatment period|participants who completed the treatment period with data to evaluate exacerbations|||Participants|||Count of Participants
2609357|NCT02066402|Secondary|Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set|Clinical Failure: Presence of fever; No lesion size decrease from baseline; Clinician assessment of tenderness worse than mild; Persistent same or great intensity purulent drainage of wound infection; Confounding use of systemic concomitant antibiotic; TEAE lead to study drug discontinuation; Require additional antibiotic treatment for primary lesion; Unplanned major surgical intervention. Clinical Success: Afebrile or fever due to other cause; Lesion size decrease from baseline; Clinician assessment of mild/absent tenderness; None/lesser intensity purulent drainage of wound infection; None confounding use of systemic concomitant antibiotic; None TEAE leading to study drug discontinuation; No additional antibiotic therapy for primary lesion; No unplanned major surgical intervention; No osteomyelitis after baseline; For wound/abscess: no incision/drainage of the ABSSSI site after Day1 unless planned. For cellulitis/ersipelas: no incision/drainage of the ABSSSI site after 48‑72 H Visit.|Baseline and EOT visit (Day 11)|ITT|||Percentage of participants|||Number
2609358|NCT02066402|Primary|Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set.|Early clinical response is defined as responder if there is >=20% reduction in the area of erythema, edema, and/or induration (length × width) of the primary acute bacterial skin and skin structure infections (ABSSSI) lesion, compared with baseline at the 48-72 Hour visit.|Baseline and 48-72 hours visit|ITT|||Percentage of participants|||Number
2609359|NCT02066389|Secondary|Percentage of Participants Achieving Clinical Remission Based on CDAI at Week 12|"The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.~CR is defined as a CDAI score ≤ 2.8."|Week 12|All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF) imputation was used for participants with missing data at Week 12 if prior post-baseline data were available.|||percentage of participants|||Number
2609360|NCT02066389|Secondary|Percentage of Participants Achieving Low Disease Activity (LDA) Based on CDAI at Week 12|"The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of TJC28 and SJC28, patient global assessment of disease activity measured on a VAS from 0 to 10 cm, and physician global assessment of disease activity measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity.~LDA is defined as a CDAI score ≤ 10."|Week 12|All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF) imputation was used for participants with missing data at Week 12 if prior post-baseline data were available.|||percentage of participants|||Number
2609361|NCT02066389|Secondary|Secondary: Percentage of Participants Achieving Clinical Remission (CR) Based on DAS28(CRP) at Week 12|"The disease activity score-28-CRP (DAS28 [CRP]) assesses RA disease activity based on a continuous scale of combined measures of 28 tender joint counts (TJC28), 28 swollen joint counts (SJC28), C-reactive protein (CRP), and the patient global assessment of disease activity (measured on a visual analog scale from 0 to 100 mm). DAS28(CRP) scores range from 0 to 10 where higher scores indicate more disease activity.~CR is defined as a DAS28(CRP) score < 2.6."|Week 12|All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF) imputation was used for participants with missing data at Week 12 if prior post-baseline data were available.|||percentage of participants|||Number
2609362|NCT02066389|Secondary|Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28(CRP) at Week 12|"The disease activity score-28-CRP (DAS28 [CRP]) assesses RA disease activity based on a continuous scale of combined measures of 28 tender joint counts (TJC28), 28 swollen joint counts (SJC28), C-reactive protein (CRP), and the patient global assessment of disease activity (measured on a visual analog scale (VAS) from 0 to 100 mm). DAS28(CRP) scores range from 0 to approximately 10 where higher scores indicate more disease activity.~LDA is defined as a DAS28(CRP) score < 3.2."|Week 12|All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF) imputation was used for participants with missing data at Week 12 if prior post-baseline data were available.|||percentage of participants|||Number
2609363|NCT02066389|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12|"A participant was a responder if the following 3 criteria for improvement from baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High sensitivity C-reactive protein (hsCRP)."|Baseline and Week 12|All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF) imputation was used for participants with missing data at Week 12 if prior post-baseline data were available.|||percentage of participants|||Number
2609364|NCT02066389|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12|"A participant was a responder if the following 3 criteria for improvement from baseline were met:~≥ 50% improvement in 68-tender joint count;~≥ 50% improvement in 66-swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Physician's global assessment of disease activity~Patient's global assessment of disease activity~Patient's assessment of pain~Health Assessment Questionnaire - Disability Index (HAQ-DI)~High sensitivity C-reactive protein (hsCRP)."|Baseline and Week 12|All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF) imputation was used for participants with missing data at Week 12 if prior post-baseline data were available.|||percentage of participants|||Number
2609368|NCT02066298|Secondary|Peak Expiratory Flow Rate|Peak expiratory flow rate is a person's maximum speed of expiration. It measures the airflow through the bronchi and thus the degree of obstruction in the airways.|End of 12-week treatment period|participants who completed the treatment period and were able to provide FEV1 measurements|||liters per minute||Standard Deviation|Mean
2609369|NCT02066298|Secondary|Forced Expiratory Volume at One Second (FEV1) Percent of Predicted|FEV1, expressed as percent of predicted FEV1 based on age, sex, race, and height.|End of 12-week treatment period|participants who completed the treatment period and were able to provide FEV1 measurements|||percentage of predicted FEV1||Standard Deviation|Mean
2609370|NCT02066298|Secondary|Annualized Asthma Control Days|Asthma Control Days (ACD) are based on patient completed electronic daily diaries, and are defined as: A day with no rescue albuterol use (pre-exercise albuterol will not be counted), no non-study asthma medications, no daytime asthma symptoms (shortness of breath, wheezing, chest tightness, phlegm/mucus rated as mild, moderate or severe, or cough rated as moderate or severe), no nighttime asthma symptoms, no unscheduled healthcare visits for asthma, and no PEF < 80% of predetermined baseline. Annualized ACD are calculated as the proportion of ACD during the treatment period multiplied by 365.|End of 12-week treatment period|participants who completed the treatment period with data to evaluate asthma control days|||days||Standard Deviation|Mean
2609371|NCT02066298|Secondary|Treatment Failure|"Treatment Failure includes:~Awakening from asthma three or more times in a two-week period or on two consecutive nights, or~Using albuterol for relief of symptoms four or more times/day for two or more consecutive days, or~Albuterol has been relieving symptoms for less than four hours after each treatment over a 12-hour period, or~Using albuterol for relief of symptoms daily for seven days, and this use exceeds two times the weekly use of albuterol in the baseline period, or~exercise induces unusual breathlessness"|End of 12-week treatment period|participants who completed the treatment period with data to evaluate treatment failure outcome|||Participants|||Count of Participants
2609372|NCT02066298|Primary|Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1.|This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of treatment failures. If one treatment results in no treatment failures and another treatment does, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by treatment failures, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response.|End of 12-week treatment period|For each pairwise comparison (mometasone vs. placebo and tiotropium vs. placebo), participants were required to complete both of the relevant treatment periods in order to be included in the analysis.|||Participants|||Count of Participants
2609373|NCT02066233|Secondary|Preference for Either of the Two Procedures, EG II Scan Versus Standard Endoscopy|"Subjects were asked the following question: Based on the overall experience (including need for sedation, ability to drive, time off work, procedure comfort, procedure time, etc.). Which procedure would you prefer to have in the future? Possible answers were: Nasal camera test (EG), oral camera test (Gastroscopy), or either test."|Two weeks|Two subjects on the reflux and/or heartburn arm didn't answer this question.|||Participants|||Count of Participants
2609374|NCT02066233|Primary|Median Tolerability Score on 10-point Visual Analog Scale (VAS)|"On the 10-point VAS, 0 represented the worst experience and 10 the best experience."|Within 48 hours||||units on a scale||Full Range|Median
2609375|NCT02066181|Other Pre-specified|Changes in Immunohistochemistry Score of Beta-catenin Cytoplasm/Nuclear Ratio (Correlative Companion Study- A091105-ST1 Study)|Compared by paired t-test. Quantitative changes will be correlated with disease status at 1 year by Fishers exact test.|Baseline up to day 8|||||||
2609376|NCT02066181|Other Pre-specified|Changes in Immunohistochemistry Score of Platelet-derived Growth Factor Receptor (Correlative Companion Study- A091105-ST1 Study)|Compared by paired t-test. Quantitative changes will be correlated with disease status at 1 year by Fishers exact test.|Baseline up to day 8|||||||
2609377|NCT02066181|Other Pre-specified|Changes in Immunohistochemistry Score of Vascular Endothelial Growth Factor (Correlative Companion Study- A091105-ST1 Study)|Compared by paired t-test. Quantitative changes will be correlated with disease status at 1 year by Fishers exact test.|Baseline up to day 8|||||||
2609378|NCT02066181|Other Pre-specified|Treatment-specific Gene Expression Signature (Correlative Companion Study- A091105-ST1 Study)|The analysis will identify over- and under-expressed genes in pre-treatment and day 8 biopsies as compared to all control samples.|Up to day 8|||||||
2609379|NCT02066181|Other Pre-specified|False Discovery Rate (Correlative Companion Study- A091105-ST1 Study)|Permutation testing of the same selection will be performed 1000 times and the sample group labels switched around in each permutation. A two-sided t-test will be used to identify differentially expressed genes on log transformed data and those with a twofold change. False discovery rate will be assessed by permutation testing (n = 1000) of the sample group labels. Enrichment will be assessed by one-sided Fisher?s exact test with estimated false discovery rate.|Up to day 8|||||||
2609380|NCT02066181|Other Pre-specified|Cadherin-associated Protein, Beta 1 (CTNNB1) Genotype (Correlative Companion Study-A091105-ST1 Study)|Associations among the possible predictors of response to sorafenib and CTNNBI mutations will be examined using Fisher?s exact test, Kruskal-Wallis test, or Spearman?s correlation coefficient as appropriate. Strata will be compared by using the log-rank test. Multivariate models will be constructed by introducing all variables aforementioned simultaneously into the model and then eliminating variables using the backward selection method. P values will be two-tailed and considered significant at alpha 0.05.|Up to 3 years|||||||
2609381|NCT02066181|Other Pre-specified|Rate of Pain Palliation Measured by the ?Worst Pain? Item of the Brief Pain Inventory Short Form (Correlative Companion Study-A091105-H01 QOL Study)|Rate of pain palliation at week 8 confirmed as week 12 will be compared between arms using a two-sided alpha=0.05 chi-squared tests at the time of the final analysis. Descriptive statistics will include means, standard deviations, medians, and ranges for each continuous or ordinal scale/subscale/item by group at each time point. Descriptive graphical techniques will include mean plots by group for each continuous or ordinal scale/subscale/item. Relative frequencies of responses for each ordinal item will also be generated at each time point by group.|Baseline up to 12 weeks|||||||
2609404|NCT02065791|Secondary|All-cause Mortality|Adjudication of these events by Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on time to first occurrence of all-cause mortality are presented.|Up to 4.6 years|The ITT population consisted of all randomized participants.|||Event rate per 1000 participant-years|||Number
2609382|NCT02066181|Other Pre-specified|Duration of Pain Palliation Measured by the ?Worst Pain? Item of the Brief Pain Inventory Short Form (Correlative Companion Study- A091105-H01 QOL Study)|Defined for all patients who experience confirmed pain palliation. Descriptive statistics will include means, standard deviations, medians, and ranges for each continuous or ordinal scale/subscale/item by group at each time point. Descriptive graphical techniques will include mean plots by group for each continuous or ordinal scale/subscale/item. Relative frequencies of responses for each ordinal item will also be generated at each time point by group.|Time from the earliest date that confirmed pain palliation is observed to the earliest date that pain progression is observed, assessed up to 12 weeks|||||||
2609383|NCT02066181|Other Pre-specified|Time to Pain Palliation Measured by the ?Worst Pain? Item of the Brief Pain Inventory Short Form (Correlative Companion Study-A091105-H01 QOL Study)|Defined at each time point as >= 30% decrease from baseline in the worst pain intensity score (BPI-SF ?worst pain? item), with neither a concomitant >= 30% increase in average daily use of any opioid narcotic, nor addition of any new opioid narcotic, relative to baseline. Estimated for each arm using Kaplan-Meier estimates and will be compared between arms using a log- rank test. Descriptive statistics will include means, standard deviations, medians, and ranges for each continuous or ordinal scale/subscale/item by group at each time point.|Date of randomization to the earliest date that confirmed pain palliation is observed, assessed up to 12 weeks|||||||
2609384|NCT02066181|Other Pre-specified|Time to Pain Progression Measured by the ?Worst Pain? Item of the Brief Pain Inventory Short Form (Correlative Companion Study- A091105-H01 QOL Study)|Defined as a >= 30% increase compared with baseline in the worst pain intensity score (BPI-SF ?worst pain? item) or either a >= 30% increase in the average daily use of any type of opioid narcotic or the addition of a new opioid narcotic compared with baseline. Estimated for each arm using Kaplan-Meier estimates and will be compared between arms using a log- rank test. Descriptive statistics will include means, standard deviations, medians, and ranges for each continuous or ordinal scale/subscale/item by group at each time point.|Date of randomization to the earliest date that pain progression is observed, assessed up to 12 weeks|||||||
2609385|NCT02066181|Other Pre-specified|Percent Changes in MRI T2 Signal (Correlative Companion Study-Imaging Study)|Percent T2 signal change (continuous) will be correlated by Spearman?s rho. The percent changes in MRI T2 signal from Week 8 to subsequent imaging will be compared between groups with > 30% pain palliation using t-test or a nonparametric alternative (e.g., Wilcoxon rank-sum test).|Baseline up to 3 years|||||||
2609386|NCT02066181|Other Pre-specified|Percent Change in Tumor Size by Response Evaluation Criteria in Solid Tumors Version 1.1 (Correlative Companion Study-Imaging Study)|Best response (ordinal variable) and percent T2 signal change (continuous) will be correlated by Spearman?s rho.|Baseline up to 3 years|||||||
2609387|NCT02066181|Secondary|Duration of Response|Kaplan Meier methodology will be used to estimate the distribution of duration of response and the log-rank test will be used to test for a difference in duration of response between the two arms. Patients on Arm II (placebo) who crossover are censored for Duration of Response at the time of crossover.|Time between first tumor response and progression, assessed up to 3 years|All patients that started treatment and were assessed for response.|||Months||Inter-Quartile Range|Median
2609388|NCT02066181|Secondary|Best Objective Status Between the Two Treatment Arms According to Response Evaluation Criteria in Solid Tumors Version 1.1|Compared between the two treatment arms and using the Cochran-Mantel-Haenszel test. Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to <1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the BSD. Patients on Arm II (placebo) who crossover are censored for Best Objective Status at the time of crossover.|Up to 3 years|All patients that started treatment and were assessed for response.|||Participants|||Count of Participants
2609389|NCT02066181|Secondary|Overall Survival|Kaplan-Meier methodology and log rank tests will be used to compare overall survival between the groups at various time points (eg, 1 year rate, 2 year rate, etc) and 95% confidence intervals will be calculated for these estimates. Data following crossover will be analyzed and summarized separately from the main course of treatment for these patients in an exploratory and hypothesis generating manner.|Time between the date of randomization to until death, assessed up to 3 years|All patients that started treatment and were assessed for survival. Crossover patients were excluded/censored from secondary analysis and endpoints.|||Participants|||Count of Participants
2609390|NCT02066181|Secondary|Time to Surgical Intervention During Treatment|A log rank test will be used to compare the distributions of time to surgical intervention between the two arms using a 2-sided test and alpha=0.05 level of significance. Kaplan-Meier methodology will be used to estimate various time points and 95% confidence intervals will be calculated for these estimates. Surgery will be classified by outcome (eg, complete-macroscopic, complete-microscopic, or partial), type, location (eg, limb), thereafter analyzed by categorical analysis and descriptive statistics. Non-parametric methods will be used, as appropriate. Too few patients had surgery during treatment to perform analysis.|Time between randomization to the patient undergoing therapeutic surgical resection for this disease, assessed up to 3 years|Only the number of patients is presented due to the Protected Health Information as to the time to surgery for each of these individual patients. Crossover patients are per protocol, excluded/censored from secondary analysis and endpoints.|||Participants|||Count of Participants
2609391|NCT02066181|Secondary|Incidence of Adverse Events, Using the Patient Reported Outcomes-Common Terminology Criteria in Adverse Events Version 4.0|INCLUDED IN THE ADVERSE EVENTS PORTION OF THE RESULTS SECTION. Frequency tables, summary statistics, and categorical analysis will be used to compare the distributions of toxicity for patients treated with sorafenib tosylate vs placebo. Data for patients who have crossed over or having received surgical or radiotherapy intervention will be summarized independently from their primary course of study treatment in an exploratory and hypothesis generating manner.|Up to 3 years|Per protocol, crossover patients are excluded/censored from secondary analysis and endpoints.|||Participants|||Count of Participants
2609418|NCT02065518|Primary|Lower Extremity Strength- Chair Test|Mobility was measured by the number of complete standing and sitting cycles in 30-seconds|0, 6, 12, and 18 weeks||||Rises||Standard Deviation|Mean
2609419|NCT02065518|Primary|Lower Extremity Mobility- 6-Minute Walk Test|Mobility was measured by the distance walked at a fast pace over 6-minutes,|0, 6, 12, and 18 weeks||||Inches||Standard Deviation|Mean
2609392|NCT02066181|Primary|Progression-free Survival(PFS) Rate|PFS is defined as the time from randomization to the first occurrence of progression or death due to any cause. If no event exists, the PFS will be censored at the last disease assessment. Data following cross over will be analyzed and summarized separately from the data from the main course of treatment for these patients in an exploratory and hypothesis generating manner. Intention to treat principles will be used. Patient disease status was evaluated using RECSIT v1.1. Patients ending treatment for symptomatic deterioration without radiographic evidence of PD, were classified as having PD. Otherwise, patients not yet showing disease progression were classified as having no progression at the most recent disease assessment and in the following cases: crossing over to receive sorafenib, date of first non-protocol directed anti-cancer therapy, lost to follow-up, withdrawal of consent, and changing imaging methods from that which was used at study entry.|Time from randomization to the first occurrence of progression or death due to any cause, assessed up to 3 years|All patients that received treatment and were assessed for response.|||Participants|||Count of Participants
2609393|NCT02066129|Secondary|Number of Participants Hospitalized for Asthma|Number of participants hospitalized for asthma during the 48 week treatment period.|end of 48 week treatment period||||Participants|||Count of Participants
2609394|NCT02066129|Secondary|Unscheduled Emergency Department (ED) or Urgent Care Visits for Asthma|Rate of emergency department (ED) or urgent care visits for asthma during the 48 week treatment period.|end of 48 week treatment period||||visits per year||95% Confidence Interval|Least Squares Mean
2609395|NCT02066129|Secondary|Yellow Zone Albuterol Use|Use of albuterol rescue medication during 7-day yellow zone episodes.|end of 48 week treatment period||||number of albuterol puffs||95% Confidence Interval|Least Squares Mean
2609396|NCT02066129|Secondary|Yellow Zone Asthma Symptoms|Study participants completed a daily symptom diary. They scored the following diary elements on a scale from 0-3 (none-severe): Cough, Wheeze, Trouble Breathing, Interference With Activities. A combined score was calculated as the sum of the 4 elements and ranged from 0 to 12. The study intervention was based on yellow-zones as noted in the Study Description. This outcome was based on diary data including 21 days, beginning 7 days prior to the onset of the yellow-zone intervention and ending 14 days after the onset of the intervention. The total symptom burden outcome was defined as the sum of the combined score on each diary day and ranged from 0 to 252 (max combined score of 12 per day multiplied by 21 days). A score of zero would indicate no symptoms over the entire 21 days. A score of 252 would indicate severe cough, wheeze, shortness of breath, and interference with activities on all of the 21 days.|end of 48 week treatment period||||units on a scale||95% Confidence Interval|Least Squares Mean
2609397|NCT02066129|Primary|Asthma Exacerbations|The primary outcome is the rate of severe asthma exacerbations treated with oral corticosteroids during the 48 week treatment period.|end of 48 week treatment period||||exacerbations per year||95% Confidence Interval|Least Squares Mean
2609398|NCT02066051|Secondary|Number of Participants Who Experienced Adverse Events|Participants were screened for any sign of adverse events at each visit by the principal investigator or one of her colleagues.|12 months||||participants|||Number
2609399|NCT02066051|Primary|Number of Participants Who Responded to Intense Pulsed Light (IPL)|Participants received treatment over 4 months and were monitored for safety and response for an additional 8 months. The symptoms were scored with the Standard Patient Evaluation of Eye Dryness (SPEED2) questionnaire. The SPEED questionnaire presents the four most commonly experienced dry eye symptom groups and asks patients to tick a box for all symptoms that apply to them. The frequency section ratings run from 0 (never) to 3 (constant), and the severity section ratings run from 0 (no problems) to 4 (intolerable), for a total score ranging from 0 (no problem) to 28 (severe problems). Over a 30% improvement in the SPEED2 score equated a response. None of the subjects were expected to get a complete response due to the nature of the damage to their ocular surface from GVHD.|12 months||||participants|||Number
2609400|NCT02065895|Other Pre-specified|Nighttime Time-in-target 5.0-8.33mmol/l (Controller Set-point Plus and Minus 15 mg/dL)|Night-time in target range 5.0-8.33, following the 3 hour controller initialization period blood glucose remained at or near target.|On day #1, day #2 and day #3 (each day could be 24 hours to 7 days apart from prior one, and completed within 6 week period) 12:00 AM to 6:00 AM on day following admission, with samples obtained every 10-15 minutes, for each sequence of calibration errors|Analysis was limited to the 6 subjects completing all 3 nighttime periods per protocol|||percentage of time in target range||Inter-Quartile Range|Median
2609401|NCT02065895|Secondary|Peak and Nadir Postprandial Glucose Concentration|Highest and lowest glucose concentrations obtained during breakfast meal.|On day #1, day #2 and day #3 (each day could be 24 hours to 7 days apart from prior one, and completed within 6 week period) 8:00 AM to 12:00 PM on day following admission, with samples obtained every 10-15 minutes, for each sequence of calibration errors|Analysis was limited to the 5 subjects completed all aspects of the study per protocol (i.e. 5 subjects who completed all three scheduled breakfast meals).|||mmol/l||95% Confidence Interval|Mean
2609402|NCT02065895|Primary|Glucose Area Under the Curve (AUC) Breakfast|Glucose Area Under the Curve (AUC) Breakfast defines the total exposure to glucose during breakfast. Breakfast is typically considered the most difficult meal to control; low AUC is desirable.This outcome measure was analyzed for each of the three calibration error values (high error, no error and low error).|On day #1, day #2 and day #3 (each day could be 24 hours to 7 days apart from prior one, and completed within 6 week period) 8:00 AM to 2:00 PM on day following admission, with samples obtained every 10-15 minutes, for each sequence of calibration errors||||mmol/l/min||95% Confidence Interval|Mean
2609403|NCT02065791|Secondary|CV Composite Endpoint|The CV composite endpoint included the CV death, non-fatal MI, non-fatal stroke, hospitalized heart failure, and hospitalized unstable angina. CV death included death due to MI, stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was a CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the CV composite endpoint are presented.|Up to 4.6 years|The ITT population consisted of all randomized participant.|||Event rate per 1000 participant-years|||Number
2609420|NCT02065518|Primary|Lower Extremity Muscle Strength- Flexion|Muscle strength was measured with a handheld dynamometer for flexor knee strength of the injured and uninjured knee.|0, 3, 6, 9, 12, and 18 weeks||||Kilograms||Standard Deviation|Mean
2609405|NCT02065791|Secondary|Cardiovascular (CV) Death|CV death included death due to MI, stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was a CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of CV death are presented.|Up to 4.6 years|The ITT population consisted of all randomized participants.|||Event rate per 1000 participant-years|||Number
2609406|NCT02065791|Secondary|Renal Composite Endpoint|The renal composite endpoint included composite of DoSC, ESKD and Renal death. DoSC: from the baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an eGFR value of <15 mL/min/1.73 m^2 (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). Renal death: death in participants who have reached ESKD, died without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the renal composite endpoint are presented.|Up to 4.6 years|The ITT population consisted of all randomized participant.|||Event rate per 1000 participant-years|||Number
2609407|NCT02065791|Secondary|Hospitalized Heart Failure (HHF)|Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of hospitalized heart failure are presented.|Up to 4.6 years|The ITT population consisted of all randomized participants.|||Event rate per 1000 participant-years|||Number
2609408|NCT02065791|Secondary|Major Adverse Cardiac Event (MACE)|The composite endpoint included CV death, non-fatal MI, and non-fatal stroke (that is, 3-point MACE). Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of MACE are presented.|Up to 4.6 years|The ITT population consisted of all randomized participants.|||Event rate per 1000 participant-years|||Number
2609409|NCT02065791|Secondary|Composite Endpoint of CV Death and Hospitalized Heart Failure (HHF)|The composite endpoint included CV death and HHF. CV death included death due to myocardial infarction (MI), stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the composite endpoint of CV death and HHF are presented.|Up to 4.6 years|The ITT population consisted of all randomized participants.|||Event rate per 1000 participant-years|||Number
2609410|NCT02065791|Primary|Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death|Primary composite endpoint is the composite of DoSC, ESKD, and renal or CV death. DoSC: from baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: as initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an estimated glomerular filtration rate (eGFR) value of less than (<)15 milliliters per minute per 1.73 square meter (mL/min/1.73 m^2) (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). Renal death: death in participants who had reached ESKD, died without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by Endpoint Adjudication Committee (EAC) was performed in blinded fashion. Event rate estimated based on time to first occurrence of primary composite endpoint are presented.|Up to 4.6 years|The Intent-to-treat (ITT) population consisted of all randomized participants.|||Event rate per 1000 participant-years|||Number
2609411|NCT02065518|Secondary|Activities of Daily Living- Activity Limitation|"The Activities of Daily Living Scale was used to measure self-perceived limitations while performing typical activities. The limitation subscale ranges from Activity is not difficult  to I am unable to do the activity. Scores range from 0-45. Higher scores are associated with diminished symptoms. A mean score was calculated."|0, 3, 6, 9, 12, and 18 weeks||||score on a scale||Standard Deviation|Mean
2609412|NCT02065518|Secondary|Activities of Daily Living- Knee Symptoms|"The Activities of Daily Living Scale was used to measure self-perceived knee symptoms while performing typical activities. The knee symptom subscale ranges from I do not have the symptom to The symptom prevents me from all daily activity. Scores ranged from 0-35. Higher scores are associated with diminished symptoms. A mean score was calculated."|0, 3, 6, 9, 12, and 18 weeks||||score on a scale||Standard Deviation|Mean
2609413|NCT02065518|Secondary|Knee Pain Following Performance Testing- 2-Minute Step Test|Knee pain intensity after the 2-Minute Step Test was assessed using the Visual Analog Scale, an 11-point numerical rating scale. Participants rated current knee pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.|0, 6, 12, and 18 weeks||||score on a scale||Standard Deviation|Mean
2609414|NCT02065518|Secondary|Knee Pain Following Performance Testing- Chair Stand Test|Knee pain intensity after the 30-Second Chair Stand Test was assessed using the Visual Analog Scale, an 11-point numerical rating scale. Participants rated current knee pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.|0, 6, 12, and 18 weeks||||score on a scale||Standard Deviation|Mean
2609415|NCT02065518|Secondary|Knee Pain Following Performance Testing- 6-Minute Walk Test|Knee pain intensity after the 6-Minute Walk Test was assessed using the Visual Analog Scale, an 11-point numerical rating scale. Participants rated current knee pain intensity on a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated.|0, 6, 12, and 18 weeks||||score on a scale||Standard Deviation|Mean
2609416|NCT02065518|Secondary|Overall Pain Severity|"Pain severity was measured using item 3 from the IDKC Subjective Knee Evaluation: If you have knee pain, how severe is it? Participants responded using a scale of 0 (no pain) to 10 (worst pain imaginable). A mean pain score was calculated."|0, 3, 6, 9, 12, and 18 weeks||||score on a scale||Standard Deviation|Mean
2609417|NCT02065518|Primary|Lower Extremity Mobility and Endurance- Step Test|Mobility and endurance were measured by the number of up and down step cycles completed in 2-minutes.|0, 6, 12, and 18 weeks||||Step Cycles||Standard Deviation|Mean
2609424|NCT02065336|Secondary|Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Terminal Elimination Rate Constant (Kel), Cohorts 1-5||Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdose|PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.|||1/hr||Standard Deviation|Mean
2609425|NCT02065336|Secondary|Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Volume in Steady State (Vss), Cohorts 1-5||Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdose|PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.|||mL/kg||Standard Deviation|Mean
2609426|NCT02065336|Secondary|Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Apparent Volume of Distribution During the Terminal Phase (Vz), Cohorts 1-5||Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdose|PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.|||mL/kg||Standard Deviation|Mean
2609427|NCT02065336|Secondary|Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Clearance (CL), Cohorts 1-5||Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdose|PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.|||mL/hr/kg||Standard Deviation|Mean
2609428|NCT02065336|Secondary|Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Maximum Observed Plasma Concentration (Cmax), Cohorts 1-5||Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdose|PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.|||µg/mL||Standard Deviation|Mean
2609429|NCT02065336|Secondary|Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf), Cohorts 1-5 Only||Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdose|PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.|||µg*hr/mL||Standard Deviation|Mean
2609430|NCT02065336|Secondary|Pharmacokinetics of ARC-520 of ARC-520 Product Constituents AD0009 and AD0010: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast), Cohorts 1-5||Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdose|PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.|||µg*hr/mL||Standard Deviation|Mean
2609431|NCT02065336|Secondary|Pharmacokinetics of ARC-520 Product Constituents AD0009 and AD0010: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24), Cohorts 1-5||Day 1 predose, immediately prior to the end of infusion, 0.5, 1, 3, 6, 24, and 48 hours postdose|PK Population: all participants who received at least 1 dose of study drug and had evaluable PK data.|||µg*hr/mL||Standard Deviation|Mean
2609432|NCT02065336|Secondary|Change From Baseline in Entecavir Plasma Trough Concentration, Cohorts 1-7||Baseline, Days 1, 2, 3, 8, 15, 22, 29|Pharmacokinetic (PK) Population: all participants who received at least 1 dose of study drug and had evaluable PK data.|||ng/mL||Standard Deviation|Mean
2609433|NCT02065336|Secondary|Number of Participants With Negative Bee Venom Allergy Test Results at Baseline, Day 29, and Day 85|Bee venom allergy tests were used to assess immunoglobulin E (IgE) in Cohorts 1-7. Analysis values less than 0.35 kU/L were taken as negative.|Baseline, Day 29, Day 85|Safety Population: all participants who received any amount of study drug or placebo, and had at least 1 postdose safety assessment.|||Participants|||Count of Participants
2609434|NCT02065336|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An adverse event (AE) is any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. An SAE is any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction.Events were categorized as mild, moderate or severe. TEAEs were defined as all AEs starting or worsening after commencement of treatment with investigational product. A treatment-related TEAE was one whose relationship to treatment was noted as unlikely, possibly, or probably related.|through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 225 Cohort 10)|Safety Population: all participants who received any amount of study drug or placebo, and had at least 1 postdose safety assessment. Data for Cohort 9 was not analyzed or summarized due to limited enrollment.|||Participants|||Count of Participants
2609435|NCT02065336|Primary|Change From Baseline Over Time in Quantitative Hepatitis B Surface Antigen (HBsAG)||Baseline, through Day 85 (Cohorts 1-7) and through 24 weeks post-last dose (last dose: Day 85 Cohort 9; Day 253 Cohort 10)|Pharmacodynamic (PD) Population: all participants who received at least 1 dose of study drug and had evaluable data from at least one postdose PD assessment according to the treatment the participants were assigned.|||IU/mL||Standard Deviation|Mean
2609436|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite : Parent on Day 7---AUC(0-12h)|To determine AUC(0-12h) ratio of metabolite to that of the parent compound on Day 7.|Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ratio||Standard Deviation|Mean
2609437|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite : Parent on Day 1--AUC(0-inf)|To determine AUC(0-inf) ratio for the metabolite to that of the parent compound on Day 1|Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ratio||Standard Deviation|Mean
2609438|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Bicarbonate|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Bicarbonate"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||mmol/L||Standard Deviation|Mean
2610268|NCT02057952|Secondary|Cost-effectiveness|The cost effectiveness ratios were calculated by dividing the difference in total cost per arm by the difference in percent of subjects with 2+ kg weight loss|12 months||||Total Cost / 100 participants|||Number
2609439|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Blood Urea Nitrogen|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Blood Urea Nitrogen"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||mmol/L||Standard Deviation|Mean
2609440|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Protein|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Protein"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||g/L||Standard Deviation|Mean
2609441|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Albumin|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Albumin"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||g/L||Standard Deviation|Mean
2609442|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Phosphate|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Phosphate"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||mmol/L||Standard Deviation|Mean
2609443|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Chloride|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Chloride"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||mmol/L||Standard Deviation|Mean
2609444|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Potassium|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Potassium"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||mmol/L||Standard Deviation|Mean
2609445|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Sodium|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Sodium"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||mmol/L||Standard Deviation|Mean
2609446|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Total Bilirubin|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Total Bilirubin"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||umol/L||Standard Deviation|Mean
2609447|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Creatinine|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Creatinine"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||umol/L||Standard Deviation|Mean
2609448|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Alkaline Phosphatase|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Alkaline Phosphatase"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||ukat/L||Standard Deviation|Mean
2609449|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Aspartate Aminotransferase|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Aspartate Aminotransferase"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||ukat/L||Standard Deviation|Mean
2609450|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Alanine Aminotransferase|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Alanine Aminotransferase"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||ukat/L||Standard Deviation|Mean
2609451|NCT02064985|Secondary|Safety---Clinical Chemistry Variables Over Time---Glucose|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Clinical Chemistry---Glucose"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||mmol/L||Standard Deviation|Mean
2609452|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---Platelets|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---Platelets"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||10^9/L||Standard Deviation|Mean
2609653|NCT02063698|Secondary|Worst Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4|The maximum grade for each type of toxicity will be recorded for each patient. The count of participants with worst adverse events considered at least possibly related to treatment by maximum grade are reported below.|Up to 28 days||||Participants|||Count of Participants
2609453|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---Leukocytes|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---Leukocytes"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||10^9/L||Standard Deviation|Mean
2609454|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---Hemoglobin|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---Hemoglobin"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||g/L||Standard Deviation|Mean
2609455|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---Erythrocytes|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---Erythrocytes"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||10^12/L||Standard Deviation|Mean
2609456|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(3)|Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2609457|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(2)|Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---AUC(0-12h)|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2609458|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(2)|Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---AUC(0-12h), AUC(0-t) and AUC(0-inf)|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2609459|NCT02064985|Secondary|Safety---Vital Signs Over Time---Pulse Rate|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Vital signs (Pulse Rate)"|Baseline, Day 1 to Day 7 and 2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||BEATS/MIN||Standard Deviation|Mean
2609460|NCT02064985|Secondary|Safety---Vital Signs Over Time---Weight|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Vital signs (Weight)"|Baseline|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||kg||Standard Deviation|Mean
2609461|NCT02064985|Secondary|Safety---Vital Signs Over Time---Height|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Vital signs (Height)"|Baseline|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||cm||Standard Deviation|Mean
2609462|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 7(4)|Pharmacokinetics parameters of Ticagrelor on Day 7---Accumulation ratio(ratio of Day 7 AUC(0-12h) to Day 1 AUC(0-12h))|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2609463|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 7(3)|Pharmacokinetics parameters of Ticagrelor on Day 7---AUC(0-12h)|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2609464|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 1(1)|The pharmacokinetics parameters of Ticagrelor on Day 1---Cmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2609465|NCT02064985|Secondary|Safety---Causally Related Adverse Events by System Organ Class and Preferred Term|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Assessment of adverse events"|Includes adverse events with an onset date on or after the date of first dose and up to and including the last study visit (up to 2-5 days after last dose).|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||Participants|||Number
2610328|NCT02057575|Primary|Intraocular Pressure (IOP)|The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29.|Study treatment was administered for 28 days, and outcome measures collected on Day 29|Modified intent to treat (mITT) population|||mmHg||Standard Deviation|Mean
2609466|NCT02064985|Secondary|Safety---All Allowed Concomitant Medications During Study Treatment|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Concomitant medications"|All allowed concomitant medications during study treatment(up to 2-5 days after last dose), includes medications that began prior to randomization but were ongoing after randomization.|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||Participants|||Number
2609467|NCT02064985|Secondary|Safety---Hematology Laboratory Variables Over Time---hematocrit|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Haematology---hematocrit"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||ratio||Standard Deviation|Mean
2609468|NCT02064985|Secondary|Safety---Physical Examination, Summary of Abnormalities|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Physical examination"|2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||Participants|||Number
2609469|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite : Parent on Day 7---Cmax|To determine Cmax ratio of metabolite to that of the parent compound on Day 7|Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ratio||Standard Deviation|Mean
2609470|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite : Parent on Day 1--Cmax|To determine Cmax ratio for the metabolite to that of the parent compound on Day 1|Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ratio||Standard Deviation|Mean
2609471|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(4)|Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 7---tmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||hour||Full Range|Median
2609472|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 7(1)|Pharmacokinetics parameters of Metabolite (AR-C124910XX) on Day 7---Cmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2609473|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(3)|Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1: tmax and t1/2|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||hour||Full Range|Median
2609474|NCT02064985|Secondary|Pharmacokinetics Parameters of Metabolite (AR-C124910XX) on Day 1(1)|Pharmacokinetics parameters of AR-C124910XX (active metabolite) on Day 1---Cmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2609475|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 7(2)|The pharmacokinetics parameters of ticagrelor on Day 7---tmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||hour||Full Range|Median
2609476|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 1(2)|The pharmacokinetics parameters of Ticagrelor on Day 1---AUC(0-inf), AUC(0-12h) and AUC(0-t).|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2609477|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 1(3)|The pharmacokinetics parameter of ticagrelor on Day 1---tmax and t1/2|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||hour||Full Range|Median
2609478|NCT02064985|Secondary|AUEC(Final Extent) on Day 7|The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.|IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).|||%*h||Standard Deviation|Mean
2609697|NCT02063178|Secondary|The Relationship Between Dietary and Physical Activity Self-monitoring Adherence and Percent Weight Loss|We will evaluate the impact of dietary and physical activity self-monitoring adherence (using Lose It website/app) on weight loss outcome.|12 month intervention||||Spearman's rho correlation|||Number
2609479|NCT02064985|Secondary|AUEC(Final Extent) on Day 1|The area-under-the-effect curve (AUEC) was estimated for ADP-induced final extent IPA.|IPA was measured at Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 36, and 48 hours post dose on Day 1|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).|||%*h||Standard Deviation|Mean
2609480|NCT02064985|Secondary|TIPA(Max)---Day 7|The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.|Day 7|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).|||hour||Inter-Quartile Range|Median
2609481|NCT02064985|Secondary|TIPA(Max)---Day 1|The time to peak IPA (TIPAmax) was estimated for ADP-induced final extent IPA.|Day 1|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).|||hour||Inter-Quartile Range|Median
2609482|NCT02064985|Secondary|Percent Change From Baseline in PRU on Day 7|Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.|Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).|||% change from baseline||Standard Deviation|Mean
2609483|NCT02064985|Primary|IPA on Day 7|"The inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily).~Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA)."|Baseline and at 0 hour, 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours after dose intake on Day 7|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).|||% IPA||Standard Deviation|Mean
2609484|NCT02064985|Secondary|Safety---Vital Signs Over Time---Blood Pressure|"The safety of ticagrelor in Chinese patients with stable coronary heart disease on chronic low dose ASA.~Safety will be assessed by:~• Vital signs (seated blood pressure [BP])"|Baseline, Day 1 to Day 7 and 2 to 5 days after last dose|All patients who receive at least one administration of the investigational product and for whom any post-dose data are available will be included in the safety analysis set.|||mmHg||Standard Deviation|Mean
2609485|NCT02064985|Secondary|Pharmacokinetics Parameters of Ticagrelor on Day 7(1)|Pharmacokinetics parameters of Ticagrelor on Day 7---Cmax|Plasma concentration was measured at Pre-dose, 0.5, 1, 2, 3, 6 and 12 hours post dose on Day 7|All randomized patients who received at least one dose of investigational product with post-dose PK measurements available and no protocol deviation considered to significantly affect PK of ticagrelor and its metabolite, AR C124910XX, will be included in the PK analysis set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2609486|NCT02064985|Secondary|Percent Change From Baseline in PRU on Day 1|Percent Change from baseline in Platelet P2Y12 Reaction Units (PRU)(measured by VerifyNow) profiles of multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease on chronic low dose ASA.|Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1|All randomized patients who received at least one dose of investigational product with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (e.g., non-compliance with study drug) will be included in the PD analysis set.|||% change from baseline||Standard Deviation|Mean
2609487|NCT02064985|Primary|IPA on Day 1|"The Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily).~Primary variable: IPA (final extent) induced by 20µM ADP at each assessment point after single and multiple doses of ticagrelor measured by Light-Transmittance Aggregometry (LTA)."|Baseline and at 0.5 hour, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 24 hours, 36 hours,48 hours after dose intake on Day 1|All randomly assigned patients who received at least 1 dose of ticagrelor with post-dose PD measurements available and no protocol deviation considered to significantly affect the integrity of PD results (eg, non-compliance with study drug).|||% IPA||Standard Deviation|Mean
2609488|NCT02064920|Secondary|Percentage of Correct Responses in the OCL Task Over 12 Weeks of Treatment|OCL is one of the Cogstate battery of tests, and is a continuous visual recognition task that assesses visual recognition, memory and attention using a pattern separation algorithm. The percentage of correct responses to 80 OCL questions is defined as the number of correct responses x 100 divided by the number of total responses; and ranges from 0 to 100, where 100 is best, and 0 is the worst outcome.|Weeks 4, 8, 12 and 16|All participants who received study medication and yielded at least one measurement for that endpoint.|||Percentage of Corrrect Responses||Standard Deviation|Mean
2609489|NCT02064920|Primary|One-card Learning (OCL) Measurement Over 12 Weeks of Treatment|OCL is one of the Cogstate battery of tests, and is a continuous visual recognition task that assesses visual recognition, memory and attention using a pattern separation algorithm. OCL is a score defined as the arcsine transformation of the square root of the proportion of correct responses to 80 OCL questions. The score ranges from 0 to 1.5708 where a higher score means better performance.|Weeks 4, 8, 12 and 16|All participants who received study medication and yielded at least one measurement for that endpoint.|||Score on a scale||Standard Deviation|Mean
2609490|NCT02064907|Primary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval on Day 5|AUC(0-tau) is a measure of the area under the plasma concentration-time curve from time 0 to time tau over a dosing interval, where tau is the length of the dosing interval (24 hours).|Day 5 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.|||ng*hr/mL||Standard Deviation|Mean
2609491|NCT02064907|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity on Day 1|AUC(0-inf) is a measure of the area under the plasma concentration-time curve from time 0 extrapolated to infinity.|Day 1 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.|||ng*hr/mL||Standard Deviation|Mean
2609492|NCT02064907|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 5|AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration.|Day 5 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.|||ng*hr/mL||Standard Deviation|Mean
2609493|NCT02064907|Primary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration on Day 1|AUC(0-tlqc) is a measure of total plasma exposure to a drug from time 0 to time of the last quantifiable concentration.|Day 1 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.|||ng*hr/mL||Standard Deviation|Mean
2609494|NCT02064907|Primary|Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 5|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 5 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.|||ng/mL||Standard Deviation|Mean
2609495|NCT02064907|Primary|Cmax: Maximum Observed Plasma Concentration for Dexlansoprazole on Day 1.|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Day 1 predose and up to 24 hours post-dose|Participants from the PK population - all participants who received at least 1 dose of study drug and had at least 1 measurable plasma concentration-with data available for analysis.|||ng/mL||Standard Deviation|Mean
2609496|NCT02064894|Secondary|Serious Adverse Event - Side Effects and Serious Adverse Events|To verify the occurence of any serious adverse event, such as respiratory depression or deep sedation, during all the time-periods of the study|60, 90 and 120 minutes||||Participants|||Count of Participants
2609497|NCT02064894|Primary|Pain Intensity - Percentage of Children Who Achieved VAS < 30 mm|"Percentage of participants which pain intensity has decreased under 30 mm on the VAS at 60 minutes.~The Visual Analogue Scale is a 0 to 100 mm continuous scale measuring the pain intensity. Score of 0=No Pain; Score of 100=Worst imaginable pain"|60 minutes post-analgesia||||Percentage of participants||95% Confidence Interval|Number
2609498|NCT02064868|Secondary|Change From Baseline in Health-related Quality of Life Index Value, Assessed by EuroQoL EQ-5D-5L Questionnaire.|EQ-5D-5L is a questionnaire designed to assess health status in adults consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The results were converted into a single index value using UK as the reference country for all countries. Range -0.3 (worst possible state) to 1 (best possible state).|Baseline, Day 5, Day 14|Full Analysis Set (only evaluable patients with non-missing information included)|||units on a scale||Standard Deviation|Mean
2609499|NCT02064868|Secondary|Percentage of Participants With Adverse Events as Assessment of Safety and Tolerability of Serelaxin in AHF Patients||Adverse Events (AE): 5 Days / Serious Adverse Events (SAE): 14 days / All cause deaths 30 days|Safety Set|||Percentage of participants|||Number
2609500|NCT02064868|Secondary|Length of Index Hospital Stay|Length of stay (in hours) is defined as the index hospitalization discharge date and time minus the index hospitalization start date and time.|30 Days|Full Analysis Set|||hours||Standard Deviation|Mean
2609501|NCT02064868|Secondary|Percentage of Participants With Renal Deterioration at Any Post Baseline Visit Through Day 14|Renal deterioration is defined as > or = 0.3 mg/dL increase from screening in serum creatinine.|14 days|Full Analysis Set (only evaluable patients with non-missing information included)|||Percentage of Participants||95% Confidence Interval|Number
2609502|NCT02064868|Secondary|Percentage of Participants With Persistent Sign or Symptoms of Heart Failure / Non-Improvement at Any Post Baseline Visit Through Day 5|Persistent or non-improvement in any signs or symptoms of HF at any post baseline visit up to Day 5.|5 days|Full Analysis Set (only evaluable patients with non-missing information included)|||Percentage of Participants||95% Confidence Interval|Number
2609503|NCT02064868|Secondary|Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14|WHF/death/readmission for heart failure through Day 14. WHF/deaths through Day 5 were adjudicated and confirmed by the Clinical Endpoint Committee, WHF/deaths after Day 5 through Day 14 and readmission through Day 14 were as reported by the investigators.|14 days|Full Analysis Set|||Percentage of Patients|||Number
2609504|NCT02064868|Primary|Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5|In-hospital WHF through Day 5 post-randomization included worsening signs and/or symptoms of heart failure that required an intensification of intravenous therapy for heart failure or mechanical ventilation, renal or circulatory support. A central event adjudication committee was appointed to oversee the WHF primary endpoint adjudication.|5 days|Full Analysis Set|||Percentage of Participants|||Number
2609505|NCT02064816|Secondary|Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. The term TEAE is defined as AEs starting or worsening after the first intake of the study drug.|Baseline up to Week 12|The Safety Analysis Set (SAF) included all subjects in the ITT who received at least 1 dose of the planned study treatment.|||Subjects|||Number
2609698|NCT02063178|Secondary|The Relationship Between Attendance and Percent Weight Loss|Evaluating the impact of intervention session attendance on percent weight loss outcome, as a measure of adherence.|12 month intervention||||spearman rho correlation|||Number
2609506|NCT02064816|Secondary|Correlation Between Change From Baseline in Cytokines (Leptin, Resistin and Adiponectin) and Hormone-like Cytokine Levels (Interleukin-6, 10 and 12), and TST and REM Sleep Time at Week 12|Correlations between change from baseline at Week 12 in TST or REM sleep and the area under the curve (AUC) calculated using the trapezoidal method for cytokine levels (i.e., leptin, resistin, adiponectin, Interleukin (IL)-12, IL 10, and IL 6) were analyzed using Pearson's correlation coefficient. Polysomnography (PSG) was performed for subjects who participated in the sub study.|Baseline and Week 12|"The SSAS included all subjects in the ITT who were enrolled in the sub study. Here, Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure. Here Number Analyzed signifies those subjects who were evaluable for this outcome measure for specified category."|||Correlation Coefficient|||Number
2609507|NCT02064816|Secondary|Change From Baseline in Total Sleep Time (TST) and Rapid Eye Movement (REM) Sleep Time at Week 12|Polysomnography (PSG) was performed for subjects who participated in the sub study. PSG is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine. Total sleep time is the total of all REM and non-REM sleep in a sleep episode.|Baseline and Week 12|"The SSAS included all subjects in the ITT who were enrolled in the sub study. Here, Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure. Here Number Analyzed signifies those subjects who were evaluable for this outcome measure for specified category."|||minutes||Full Range|Median
2609508|NCT02064816|Secondary|Change From Baseline in Hormone-Like Cytokine (Interleukin-6, 10 and 12) Levels at Week 12||Baseline and Week 12|"The SSAS included all subjects in the ITT who were enrolled in the sub study. Here, Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure. Here Number Analyzed signifies those subjects who were evaluable for this outcome measure for specified category."|||Pico gram/milliliter (pg/mL)||95% Confidence Interval|Least Squares Mean
2609509|NCT02064816|Secondary|Change From Baseline in Cytokine (Adiponectin) Level at Week 12||Baseline and Week 12|"The SSAS included all subjects in the ITT who were enrolled in the sub study. Here, Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure."|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Least Squares Mean
2609510|NCT02064816|Secondary|Change From Baseline in Cytokines (Leptin and Resistin) Levels at Week 12|Results are presented for cytokines: leptin and resistin.|Baseline and Week 12|"The Sub study Analysis Set (SSAS) included all subjects in the ITT who were enrolled in the sub study. Here, Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure."|||Nanogram/milliliter (ng/mL)||95% Confidence Interval|Least Squares Mean
2609511|NCT02064816|Secondary|Correlation Between Change From Baseline in Circulating Levels of Cytokines and in Other MSTCQ Items, HADS, FSS, PSQI and MusiQOL Scores at Week 12|Correlation was assessed by using Pearson correlation coefficient. MSTCQ, HADS, FSS, PSQI and MusiQOL are described in the above endpoints. Following abbreviations used in the categories: Global side-effects (GLOBSE); description of pain (PAINDESCR).|Baseline and Week 12|"The ITT included all subjects enrolled into the study and assigned to the RebiSmart device. Here, Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure. Here Number Analyzed signifies those subjects who were evaluable for this outcome measure for specified category."|||Correlation Coefficient|||Number
2609512|NCT02064816|Secondary|Correlation Between Change From Baseline in Circulating Levels of Cytokines (Leptin, Resistin and Adiponectin) and in Flu Like Symptom (FLS) Score at Week 12|Correlation was assessed by using Pearson correlation coefficient. The MSTCQ was used as a tool to measure treatment satisfaction, focusing on the attributes specific to MS medications. The FLS subscale of MSTCQ was defined as the sum of the scores for questions 13 to 16 with a minimum possible total FLS score = 1 and a maximum possible total FLS score = 20. Lower score indicates lower flu like symptoms and better satisfaction.|Baseline and Week 12|"The ITT included all subjects enrolled into the study and assigned to the RebiSmart device. Here, Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure."|||Correlation coefficient|||Number
2609513|NCT02064816|Secondary|Change From Baseline in Circulating Levels of Cytokines at Week 12|Results are presented for three cytokines: leptin, resistin and adiponectin.|Baseline and Week 12|"The ITT included all subjects enrolled into the study and assigned to the RebiSmart device. Here, Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure."|||microgram per liter (mcg/L)||Standard Deviation|Mean
2609514|NCT02064816|Secondary|Percentage of Subjects With Treatment Adherence at Week 4, 8 and 12|Adherence to treatment was calculated as 100 x the number of completed injections the subject administered divided by the expected number of injections. Treatment adherence was divided in two categories: percentage of subjects with less than (<) 80 percent adherence and percentage of subjects with more than or equal to (>=) 80 percent adherence.|Week 4, 8 and 12|"The ITT included all subjects enrolled into the study and assigned to the RebiSmart device. Here, Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure. Here Number Analyzed signifies those subjects who were evaluable for this outcome measure for specified category."|||Percentage of subjects|||Number
2609515|NCT02064816|Secondary|Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQOL) Score at Week 4, 8 and 12|The MusiQoL is a validated 31-item questionnaire describing 9 dimensions: activities of daily living (8 items); psychological well-being (4 items); symptoms (3 items); relationships with friends (4 items); relationships with family (3 items); relationship with healthcare system (3 items); sentimental and sexual life (2 items); coping (2 items); and rejection (2 items). Each of the questions was answered using a 6-point Likert scale ranging from 1 (never/not at all) to 6 (always/very much). The scores of each dimension were obtained by computing mean of the item scores of dimension with negatively worded item scores reversed so that higher scores indicated higher health-related quality of life (QoL). All 9 dimension scores were linearly transformed to a 0 to 100 scale and the average of the 9 dimensions was used to give a Global Score ranging from 0 to 100, where higher scores indicated higher health-related quality of life (QoL).|Baseline, Week 4, 8 and 12|"The ITT included all subjects enrolled into the study and assigned to the RebiSmart device. Here, Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure. Here Number Analyzed signifies those subjects who were evaluable for this outcome measure for specified category."|||units on scale||95% Confidence Interval|Least Squares Mean
2609516|NCT02064816|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 4, 8 and 12|PSQI is a self-rated questionnaire which assess sleep quality and disturbances over a 1-month interval using seven clinically derived components of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. PSQI is a summary of 7 components. Each component is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality.|Baseline, Week 4, 8 and 12|"The ITT included all subjects enrolled into the study and assigned to the RebiSmart device. Here, Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure. Here Number Analyzed signifies those subjects who were evaluable for this outcome measure for specified category."|||units on scale||95% Confidence Interval|Least Squares Mean
2609517|NCT02064816|Secondary|Change From Baseline in Fatigue Severity Scale (FSS) Score at Week 4, 8 and 12|FSS is a method designed to assess disabling fatigue in all the individuals. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each item assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue.|Baseline, Week 4, 8 and 12|"The ITT included all subjects enrolled into the study and assigned to the RebiSmart device. Here, Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure. Here Number Analyzed signifies those subjects who were evaluable for this outcome measure for specified category."|||units on scale||95% Confidence Interval|Least Squares Mean
2609518|NCT02064816|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 4, 8 and 12|HADS was used to measure depression and anxiety in subjects. The scale was limited to 14 questions. Seven of the items related to anxiety and 7 related to depression. Each item on the questionnaire was scored from 0-3 giving a total score between 0 and 21 for either anxiety or depression where higher score indicates more anxiety/depression.|Baseline, Week 4, 8 and 12|"The ITT included all subjects enrolled into the study and assigned to the RebiSmart device. Here, Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure. Here Number Analyzed signifies those subjects who were evaluable for this outcome measure for specified category."|||units on scale||95% Confidence Interval|Least Squares Mean
2609519|NCT02064816|Secondary|Difference in Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Subscale Scores Between Rebif Morning Administration and Rebif Evening Administration Groups at Week 4, 8 and 12|MSTCQ was used as a tool to measure treatment satisfaction, focusing on attributes specific to MS medications. Following sub-scales were assessed: Injection site reactions (ISRs), Global side-effects, Benefits, Pain, Visual Analog Scale (VAS), and Rating of Pain. ISR subscale was defined as sum of scores for questions 17 to 20, with a minimum possible total score of 4 and a maximum possible total score of 20. Global side-effects subscale was defined as sum of scores for questions 21 to 23 with minimum possible total score of 3 and a maximum possible total score of 15. Benefits (question 35); description of pain (question 36); VAS (question 37); rating of pain (question 38) subscales ranged from minimum possible score of 1 and a maximum possible total score of 5. For each of the subscales, lower scores indicated better satisfaction. Difference between both the groups at Week 4, 8 and 12 for individual sub-scales is presented in statistical analysis section.|Week 4, 8 and 12|"The ITT included all subjects enrolled into the study and assigned to the RebiSmart device. Here, Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure. Here Number Analyzed signifies those subjects who were evaluable for this outcome measure for specified category."|||units on scale||95% Confidence Interval|Least Squares Mean
2609520|NCT02064816|Secondary|Difference in Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Between Rebif Morning Administration and Rebif Evening Administration Groups at Week 4 and 8|The MSTCQ was used as a tool to measure treatment satisfaction, focusing on the attributes specific to multiple sclerosis (MS) medications. The FLS subscale of MSTCQ was defined as the sum of the scores for questions 13 to 16 with a minimum possible total FLS score = 1 and a maximum possible total FLS score = 20. Lower score indicates lower flu like symptoms and better satisfaction. Difference between Rebif Morning Administration and Rebif Evening Administration groups at Week 4 and 8 is presented in statistical analysis section.|Week 4 and 8|"The ITT included all subjects enrolled into the study and assigned to the RebiSmart device. Here, Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure. Here Number Analyzed signifies those subjects who were evaluable for this outcome measure for specified category."|||units on scale||95% Confidence Interval|Least Squares Mean
2609521|NCT02064816|Primary|Difference in Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Between Rebif Morning Administration and Rebif Evening Administration Groups at Week 12|The MSTCQ was used as a tool to measure treatment satisfaction, focusing on the attributes specific to multiple sclerosis (MS) medications. The FLS subscale of MSTCQ was defined as the sum of the scores for questions 13 to 16 with a minimum possible total FLS score = 1 and a maximum possible total FLS score = 20. Lower score indicates lower flu like symptoms and better satisfaction. Difference between Rebif Morning Administration and Rebif Evening Administration groups at Week 12 is presented in statistical analysis section.|Week 12|"The ITT included all subjects enrolled into the study and assigned to the RebiSmart device. Here, Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure. Missing data on FLS were imputed using the last observation carried forward (LOCF) method."|||units on scale||Standard Deviation|Mean
2609522|NCT02064439|Secondary|Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days|The secondary safety outcome was clinically relevant non-major (CRNM) bleeding, which was adjudicated by the CIAC using the ASA criteria: the bleeding was non-major and the bleeding was associated with a study medication interruption of more than 14 days.|Up to 12 months, at least 6 months||||participants|||Number
2609523|NCT02064439|Secondary|Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism|The secondary efficacy outcome is the composite of the primary efficacy outcome, myocardial infarction (MI), ischemic stroke or non-central nervous system (CNS) systemic embolism. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.|Up to 12 months, at least 6 months||||participants|||Number
2609524|NCT02064439|Primary|Number of Participants With First Treatment-emergent Major Bleeding|"The principal safety outcome was major bleeding which was defined according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) as clinically overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death.~Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant."|Up to 12 months, at least 6 months||||participants|||Number
2609525|NCT02064439|Primary|Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism|"The primary efficacy outcomes (i.e., recurrent venous thromboembolism [VTE] defined as composite of fatal or non-fatal symptomatic recurrent VTE, including unexplained death for which pulmonary embolism [PE] could not be ruled out) as confirmed by the central independent adjudication committee (CIAC) were considered up to the end of the individual intended duration of treatment.~Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant."|Up to 12 months, at least 6 months||||participants|||Number
2609526|NCT02064387|Secondary|CBR- Part 2|CBR was calculated as the number of participants with best overall response of sCR, CR, VGPR, PR and MR.|From the Start of Treatment (at First Dose) up to the earlier of disease progression or the start of new anti-cancer therapy (maximum duration of follow-up is 24.2 months)|Part 2 MM Population|||Participants|||Count of Participants
2609527|NCT02064387|Secondary|Clinical Benefit Rate (CBR)- Part 1|CBR was calculated as the number of participants with best overall response of sCR, CR, VGPR, PR and minimal response (MR).|From the Start of Treatment (at First Dose) up to the earlier of disease progression or the start of new anti-cancer therapy (maximum duration of follow-up is 21.6 months)|Part 1 Population|||Participants|||Count of Participants
2609528|NCT02064387|Secondary|ORR-Part 2|ORR was determined by the investigator according to IMWG 2011 uniform response criteria for MM. ORR was calculated as the number of participants with best overall response of sCR, CR, VGPR and PR.|From the Start of Treatment (at First Dose) up to the earlier of disease progression or the start of new anti-cancer therapy (maximum duration of follow-up is 24.2 months)|Part 2 MM Population|||Participants|||Count of Participants
2609529|NCT02064387|Secondary|Overall Response Rate (ORR)- Part 1|ORR was determined by the investigator according to international myeloma working group uniform response criteria for MM (IMWG 2011). ORR was calculated as the number of participants with best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR).|From the Start of Treatment (at First Dose) up to the earlier of disease progression or the start of new anti-cancer therapy (maximum duration of follow-up is 21.6 months)|Part 1 Population|||Participants|||Count of Participants
2609530|NCT02064387|Secondary|Number of Participants With Antibodies to GSK2857916 in Serum Over Time- Part 2|Serum samples were collected for the determination of ADA using a validated ECL immunoassay. The assay involved screening, confirmation and titration steps. If serum samples contained ADA, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive samples were titrated to obtain the titers of antibodies. The number of participants with screening, confirming and negative conclusive ADA results at Baseline and different timepoints is presented.|Baseline, Day 1 (Cycle 2, 3, 6, 7, 9, 11, 12, 16), End of study (within 30 days [+ 7 days of last treatment or prior to the start of new anti-cancer treatment], whichever is earlier) (1 cycle=21 days)|Part 2 MM Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2609531|NCT02064387|Secondary|Number of Participants With Antibodies to GSK2857916 in Serum Over Time- Part 1|Serum samples were collected for the determination of ADA using a validated ECL immunoassay. The assay involved screening, confirmation and titration steps. If serum samples contained ADA, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive (pos) samples were titrated to obtain the titers of antibodies. The number of participants with screening, confirming and negative (neg) conclusive ADA results at Baseline and different timepoints is presented.|Baseline, Day 1 (Cycle 2, 3, 4, 6, 9, 12, 16), End of study (within 30 days [+ 7 days of last treatment or prior to the start of new anti-cancer treatment], whichever is earlier) (1 cycle=21 days)|Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2609532|NCT02064387|Secondary|Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-drug Antibody Result- Part 2|Serum samples were collected for the determination of anti-GSK2857916 antibodies (ADA) using a validated ECLimmunoassay. The assay involved screening, confirmation and titration steps. If serum samples contained ADA, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive samples were titrated to obtain the titers of antibodies. The number of participants with at least one confirmed positive ADA at any time post-Baseline is presented.|Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)|Part 2 MM Population. Only those participants with data available at the specified data points were analyzed.|||Participants|||Count of Participants
2609533|NCT02064387|Secondary|Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-drug Antibody Result- Part 1|Serum samples were collected for the determination of anti-GSK2857916 antibodies (ADA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples contained ADA, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive samples were titrated to obtain the titers of antibodies. The number of participants with at least one confirmed positive ADA at any time post-Baseline is presented.|Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)|Part 1 Population|||Participants|||Count of Participants
2609534|NCT02064387|Secondary|Tmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With Relapsed/Refractory MM-Part 1: GSK2857916 2.50 mg/kg|Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods. Median and full range of Tmax have been presented.|Pre-dose and EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.||||||
2609535|NCT02064387|Secondary|Tmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With Relapsed/Refractory MM- Part 1|Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods. Median and full range of Tmax have been presented.|Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.|||Hours||Full Range|Median
2609536|NCT02064387|Secondary|Ctrough of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With Relapsed/Refractory MM- Part 1: GSK2857916 2.50 mg/kg|Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods. NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.|Pre-dose and EOI of Day 1 (Cycle 1, Cycle 2 and Cycle 4)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2609537|NCT02064387|Secondary|Ctrough of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With Relapsed/Refractory MM- Part 1|Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods. NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.|Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1), Pre-dose and EOI of Day 1 (Cycle 2 and Cycle 4)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2609538|NCT02064387|Secondary|Cmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With Relapsed/Refractory MM- Part 1: GSK2857916 2.50 mg/kg|Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.|Pre-dose and EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.||||||
2609539|NCT02064387|Secondary|Cmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With Relapsed/Refractory MM- Part 1|Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.|Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.|||Picograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2609540|NCT02064387|Secondary|AUC(0-tlast) of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With Relapsed/Refractory MM- Part 1: GSK2857916 2.50 mg/kg|Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.|Pre-dose and EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.||||||
2609541|NCT02064387|Secondary|AUC(0-tlast) of Cys Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With Relapsed/Refractory MM- Part 1|Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.|Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.|||Hours*picogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2609542|NCT02064387|Secondary|Ctrough of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM-Part 2|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.|Pre-dose and EOI of Day 1 (Cycle 1, Cycle 2 and Cycle 4)|PK Part 2 MM Population comprised of Part 2 MM participants of All Treated Population who had atleast 1 non-missing (NQ) PK assessment. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2609543|NCT02064387|Secondary|Tmax of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1: GSK2857916 2.50 mg/kg|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. Median and full range of Tmax have been presented.|Pre-dose and EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.||||||
2609544|NCT02064387|Secondary|Time to Reach Maximum Observed Concentration (Tmax) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. Median and full range of Tmax have been presented.|Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.|||Hours||Full Range|Median
2609545|NCT02064387|Secondary|Vss of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1: GSK2857916 2.50 mg/kg|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.|Pre-dose and EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.||||||
2609546|NCT02064387|Secondary|Volume of Distribution at Steady State (Vss) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.|Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.|||Milliliter||Geometric Coefficient of Variation|Geometric Mean
2609547|NCT02064387|Secondary|t1/2 of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1: GSK2857916 2.50 mg/kg|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.|Pre-dose and EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.||||||
2609548|NCT02064387|Secondary|Terminal Half-life (t1/2) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.|Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2609549|NCT02064387|Secondary|Ctrough of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1: GSK2857916 2.50 mg/kg|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.|Pre-dose and EOI of Day 1 (Cycle 1, Cycle 2 and Cycle 4)|PK Part 1 Population.Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2609550|NCT02064387|Secondary|Trough Plasma Concentration (Ctrough) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable. NA indicates that geometric coefficient of variation could not be calculated for a single participant.|Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1), Pre-dose and EOI of Day 1 (Cycle 2 and Cycle 4)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2609551|NCT02064387|Secondary|Cmax of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1: GSK2857916 2.50 mg/kg|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.|Pre-dose and EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.||||||
2609552|NCT02064387|Secondary|Maximum Observed Concentration (Cmax) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.|Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2609553|NCT02064387|Secondary|CL of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1: GSK2857916 2.50 mg/kg|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.|Pre-dose and EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.||||||
2609554|NCT02064387|Secondary|Clearance (CL) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.|Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.|||Milliliter per hour||Geometric Coefficient of Variation|Geometric Mean
2609555|NCT02064387|Secondary|AUC[0-tlast]) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM- Part 1: GSK2857916 2.50 mg/kg|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.|Pre-dose and EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.||||||
2609556|NCT02064387|Secondary|Area Under the Concentration-time Curve From Zero to Time of Last Quantifiable Concentration (AUC[0-tlast]) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM- Part 1|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.|Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2609557|NCT02064387|Secondary|AUC[0-tau] of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM- Part 1: GSK2857916 2.50 mg/kg|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.|Pre-dose and EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.||||||
2609558|NCT02064387|Secondary|Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM- Part 1|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.|Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2609559|NCT02064387|Secondary|AUC[0-infinity] of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM- Part 1: GSK2857916 2.50 mg/kg|Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.|Pre-dose and EOI of Day 1 (Cycle 1)|PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.||||||
2609597|NCT02064166|Other Pre-specified|Brief Visuospatial Memory Test-Revised (BVMT-R)|Changes in Brief Visuospatial Memory Test-Revised (BMVT-R) compared to baseline. For BVMT, there were concerns about the test administration and validity of this test which relies on fine motor control in PD patients that have motor impairment which could affect the drawing precision. Therefore, BVMT was not included in the analyses, because these methodological concerns would have affected the calculation of the total score as the outcome measure.|Baseline and post-treatment|||||||
2609560|NCT02064387|Secondary|Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM- Part 1|Blood samples were collected at designated timepoints. Pharmacokinetic (PK) parameters of GSK2857916 were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.|Pre-dose, 30 minutes post start of infusion (SOI), at end of infusion (EOI), 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)|PK Part 1 Population comprised of Part 1 participants of All Treated Population who had atleast 1 non-missing (non-quantifiable, NQ values were considered non-missing) PK assessment. Only those participants with data available at the specified data points were analyzed.|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2609561|NCT02064387|Primary|Change From Baseline in Urine Protein Excretion (24 Hour)-Part 2|Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented|Baseline and Day 1 (Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)|Part 2 MM Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Grams per day||Standard Deviation|Mean
2609562|NCT02064387|Primary|Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 3.40 mg/kg and 4.60 mg/kg|Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented|Baseline and Day 1 (Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)|Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). NA indicates that standard deviation could not be calculated for a single participant.|||Grams per day||Standard Deviation|Mean
2609563|NCT02064387|Primary|Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 2.50 mg/kg|Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented|Baseline and Day 1 (Cycle 2, 3, 4, 5, 6, 7, 8, 10, 12, 13, 14, 15, 16)|Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). NA indicates that standard deviation could not be calculated for a single participant.|||Grams per day||Standard Deviation|Mean
2609564|NCT02064387|Primary|Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 1.92 mg/kg|Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented|Baseline and Day 1 (Cycle 2, 3, 4, 5, 6, 7, 8, 11, 12, 13, 14, 16)|Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). NA indicates that standard deviation could not be calculated for a single participant.|||Grams per day||Standard Deviation|Mean
2609565|NCT02064387|Primary|Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.96 mg/kg|Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented|Baseline and Day 1 (Cycle 2, 3, 4, 5, 6)|Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). NA indicates that standard deviation could not be calculated for a single participant.|||Grams per day||Standard Deviation|Mean
2609566|NCT02064387|Primary|Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.48 mg/kg|Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented|Baseline and Day 1 (Cycle 2, 3, 5, 6, 7, 8)|Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). NA indicates that standard deviation could not be calculated for a single participant.|||Grams per day||Standard Deviation|Mean
2609567|NCT02064387|Primary|Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.24 mg/kg|Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented|Baseline and Day 1 (Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 13,14, 15)|Part 1 Population. Only those participants with data available at the specified data points were analyzed. NA indicates that standard deviation could not be calculated for a single participant.|||Grams per day||Standard Deviation|Mean
2609568|NCT02064387|Primary|Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.03 mg/kg and 0.12 mg/kg|Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented|Baseline and Day 1 (Cycle 2)|Part 1 Population. Only those participants with data available at the specified data points were analyzed.|||Grams per day||Standard Deviation|Mean
2609569|NCT02064387|Primary|Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.06 mg/kg|Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented|Baseline and Day 1 (Cycle 2 and 3)|Part 1 Population. NA indicates that standard deviation could not be calculated for a single participant.|||Grams per day||Standard Deviation|Mean
2609570|NCT02064387|Primary|Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method -Part 2|Urine samples were collected to assess urine OB and urine Pro. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as no change/decreased, increase to small (indicated by trace and 1+), increase to moderate (indicated by 2+) and increase to large (indicated by 3+ and above) for urine OB and no change/decreased, increase to trace, increase to 1+, increase to 2+ and increase to 3+ for urine Pro indicating proportional concentrations in the urine sample. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.|Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)|Part 2 MM Population.Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2609571|NCT02064387|Primary|Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method -Part 1|Urine samples were collected to assess urine occult blood (OB) and urine protein (Pro). The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as no change/decreased, increase to small (indicated by trace and 1+), increase to moderate (indicated by 2+) and increase to large (indicated by 3+ and above) for urine OB and no change/decreased, increase to trace, increase to 1+, increase to 2+ and increase to 3+ for urine Pro indicating proportional concentrations in the urine sample. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.|Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)|Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2609572|NCT02064387|Primary|Number of Participants With Change From Baseline in Hematology Data With Respect to Normal Range-Part 2|Blood samples were collected for the analysis of following hematology parameters: baso, Eosino, Hct, MCHC, MCH, MCV, Mono, Erythro and Reticu. A laboratory value that was outside the reference range was considered either high abnormal (value above the upper limit of the reference range) or low abnormal (value below the lower limit of the reference range). Baseline was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or NC' category. Participants were counted twice if the participant 'Decreased to Low' and 'Increased to High' during post-Baseline.Data at worst-case post Baseline is presented.|Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)|Part 2 MM Population.Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2609573|NCT02064387|Primary|Number of Participants With Change From Baseline in Hematology Data With Respect to Normal Range-Part 1|Blood samples were collected for the analysis of following hematology parameters: basophils (baso), eosinophils (Eosino), hematocrit (Hct), mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes (Mono), erythrocytes (Erythro) and reticulocytes (Reticu). A laboratory value that was outside the reference range was considered either high abnormal (value above the upper limit of the reference range) or low abnormal (value below the lower limit of the reference range). Baseline was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or NC' category. Participants were counted twice if the participant 'Decreased to Low' and 'Increased to High' during post-Baseline.Data at worst-case post Baseline is presented.|Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)|Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2609574|NCT02064387|Primary|Number of Participants With Grade Change From Baseline in Hematology Data-Part 2|Blood samples were collected for the analysis of following hematology parameters: Hb, Lymph, Neutro, PC, and leuko. The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Baseline was defined as the latest pre-dose assessment with a non-missing value, including unscheduled visits.An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented.|Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)|Part 2 MM Population|||Participants|||Count of Participants
2609575|NCT02064387|Primary|Number of Participants With Grade Change From Baseline in Hematology Data-Part 1|Blood samples were collected for the analysis of following hematology parameters: hemoglobin (Hb), lymphocytes (Lymph), neutrophils (Neutro), platelet count (PC), and leukocytes (leuko). The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Baseline was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented.|Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)|Part 1 Population|||Participants|||Count of Participants
2609576|NCT02064387|Primary|Number of Participants With Change From Baseline in Clinical Chemistry Data With Respect to Normal Range-Part 2|Blood samples were collected for the analysis of following clinical chemistry parameters: D.Bil., chloride, CO2, LDH, T.Pro and BUN. Baseline was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits.A laboratory value that is outside the reference range was considered either high abnormal (value above the upper limit of the reference range) or low abnormal (value below the lower limit of the reference range). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or NC' category. Participants were counted twice if the participant 'Decreased to Low' and 'Increased to High' during post-Baseline.Data for worst-case post Baseline is presented.|Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)|Part 2 MM Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2609577|NCT02064387|Primary|Number of Participants With Change From Baseline in Clinical Chemistry Data With Respect to Normal Range-Part 1|"Blood samples were collected for the analysis of following clinical chemistry parameters: direct bilirubin (D.Bil.), chloride, carbon dioxide (CO2), lactate dehydrogenase (LDH), total protein (T.Pro) and urea or blood urea nitrogen (BUN). Baseline was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. A laboratory value that is outside the reference range was considered either high abnormal (value above the upper limit of the reference range) or low abnormal (value below the lower limit of the reference range). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change (NC)' category. Participants were counted twice if the participant Decreased to low and Increased to high during post-Baseline. Data for worst-case post Baseline is presented."|Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)|Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2609578|NCT02064387|Primary|Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2|Blood samples were collected for the analysis of following clinical chemistry parameters: albumin,ALP,ALT,AST,T.Bil.,Ca, Creat,CK, GGT,Gl, Pot,Mg, Sod, Ph and urate. Values(Hyper and hypo)for Gl, Pot, Mg, Sod and Ca is presented. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. All increases are an increase in grade from Baseline. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.|Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)|Part 2 MM Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2609579|NCT02064387|Primary|Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1|Blood samples were collected for the analysis of following clinical chemistry parameters: albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (T.Bil.), calcium (Ca), creatinine (Creat), creatinine kinase (CK), gamma glutamyl transferase (GGT), glucose (Gl), potassium (Pot), magnesium (Mg), sodium (Sod), phosphate (Ph) and urate. Values(Hyper and hypo)for Gl, Pot, Mg, Sod and Ca is presented. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. All increases are an increase in grade from Baseline. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.|Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)|Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2609580|NCT02064387|Primary|Number of Participants With Change From Baseline in Heart Rate and Temperature-Part 2|The following criteria was used to flag vital signs of potential clinical importance: change from Baseline in heart rate (decrease to <60 bpm and increase to >100 bpm) and change in temperature from Baseline(increase to >=38 or decrease to <=35 degree centigrade). Baseline was defined as the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.|Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)|Part 2 MM Population|||Participants|||Count of Participants
2609581|NCT02064387|Primary|Number of Participants With Change From Baseline in Heart Rate and Temperature-Part 1|The following criteria was used to flag vital signs of potential clinical importance: change from Baseline in heart rate (decrease to <60 beats per minute [bpm] and increase to >100 bpm) and change in temperature from Baseline(increase to >=38 or decrease to <=35 degree centigrade). Baseline was defined as the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.|Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)|Part 1 Population|||Participants|||Count of Participants
2609582|NCT02064387|Primary|Number of Participants With Grade Change From Baseline in Vital Signs-Part 2|Vital signs included SBP, DBP, Temp and HR. SBP and DBP were graded using NCI CTCAE version 4.0. For SBP: Grade 0-<120 mmHg, 120-139 mmHg[Grade 1], 140-159 mmHg[Grade 2], >=160 mmHg[Grade 3]); For DBP: <80 mmHg [Grade 0], 80-89[Grade 1], 90-99[Grade 2], >=100 mmHg[Grade 3]). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.|Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)|Part 2 MM Population|||Participants|||Count of Participants
2609583|NCT02064387|Primary|Number of Participants With Grade Change From Baseline in Vital Signs-Part 1|Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature (Temp) and heart rate (HR). SBP and DBP were graded using National Cancer Institute-Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. For SBP: Grade 0-<120 millimeters of mercury[mmHg], 120-139 mmHg[Grade 1], 140-159 mmHg[Grade 2], >=160 mmHg[Grade 3]); For DBP: <80 mmHg [Grade 0], 80-89[Grade 1], 90-99[Grade 2], >=100 mmHg[Grade 3]). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.|Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)|Part 1 Population|||Participants|||Count of Participants
2609598|NCT02064166|Other Pre-specified|Gait Analysis (4-meter Test)|Changes in gait compared to baseline. Data are reported as changes in average stride interval ( inch) at baseline and post treatment.|Baseline and post-treatment||||inch||Standard Deviation|Mean
2609617|NCT02063867|Secondary|All-cause Bloodstream Infections|All-cause bloodstream infections attributable to participating units. Defined as occurring >2 days into a participating unit stay through 2 days following unit discharge. Includes bacterial and yeast pathogens. Skin commensals require two positive blood cultures.|21 months|Unadjusted intention-to-treat analysis. Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)|||Hazard Ratio||95% Confidence Interval|Number
2609584|NCT02064387|Primary|Number of Participants With Dose-limiting Toxicities (DLTs) During the Determinative Period- Part 1|An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of the following criteria:albuminuria>=2000mgper24 hour which has been confirmed by repeat test at least7 days apart and is not considered to be related to disease progression, Grade4 neutropenia (without fever) lasting>=7 days, febrile neutropenia lasting>=72 hours, Grade>=3 thrombocytopenia associated with bleeding where estimated blood loss is>10 milliliter orGrade4 thrombocytopenia lasting>7 days and not responding to platelet transfusions, anyGrade3 or greaternon-hematologic toxicity as described in Common National Cancer Institute-Terminology Criteria for Adverse Events version4.0 with the exception of the following Grade3 events that can be controlled within48 hours with routine supportive measures and clinically asymptomatic electrolyte abnormalities which can be corrected within48 hours and liver toxicity meeting pre-specified GSK liver stopping criteria.|Up to Day 21 (from first dose)|DLT Evaluable Population(pop) in Part 1 comprised of All Treated Pop (participants who received at least 1 dose of study treatment) and who received a complete infusion in cycle 1 (once every 3 weeks dosing). Any Part 1 participant in the“All Treated” pop who experiences a DLT, will also be included in the DLT evaluable pop regardless of exposure.|||Participants|||Count of Participants
2609585|NCT02064387|Primary|Number of Participants With SAEs and Common (>=5%) Non-serious Adverse Events- Part 2|An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, other medical events according to medical or scientific judgement and all events of possible study treatment-induced liver injury with hyperbilirubinemia. Part 2 MM Population comprised of all Part 2 MM participants who received at least one dose of GSK2857916. SAEs and common (>=5%) non-SAEs is presented.|Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)|Part 2 MM Population|||Participants|||Count of Participants
2609586|NCT02064387|Primary|Number of Participants With Serious Adverse Events (SAEs) and Common (>=5%) Non-serious Adverse Events- Part 1|An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, other medical events according to medical or scientific judgement and all events of possible study treatment-induced liver injury with hyperbilirubinemia. Part 1 Population comprised of all Part 1 participants (exclusively MM) who received at least one dose of GSK2857916. SAEs and common (>=5%) non-SAEs is presented.|Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)|Part 1 Population|||Participants|||Count of Participants
2609587|NCT02064270|Secondary|Need for Antibiotics|The need for additional antibiotics will be recorded.|35 days (+/- 14 days)||||Participants|||Count of Participants
2609588|NCT02064270|Secondary|Return to the Operating Room|Information regarding the subject returning to the operating room within the research study time-frame will be recorded.|35 days (+/- 14 days)||||Participants|||Count of Participants
2609589|NCT02064270|Secondary|Number of Participants With Complications|Complications experienced by the subject within the study period time-frame will be recorded.|35 days (+/- 14 days)||||participants|||Number
2609590|NCT02064270|Secondary|User-friendliness for Patient|"User-Friendliness of PICO device:~Easy to use (no difficulties, no instruction needed)~Slightly difficult (needed instruction)~Minor difficulties (but able to use effectively)~Difficult (not able to use effectively)"|7 days||||Participants|||Count of Participants
2609591|NCT02064270|Secondary|Drainage Amount|"Incision Drainage:~None~Slight (barely noticed)~Moderate (significant amount, but did not have to change dressing)~Extensive (had to change dressing)"|35 days (+/- 14 days)||||Participants|||Count of Participants
2609592|NCT02064270|Primary|Incision Appearance Based on VAS (Incision Healing Assessment Form)|Visual Analog Pain Scale (VAS): PICO Study Incision Healing Assessment Form. Used to represent the assessment of incision healing based on in-person visual appearance, or appearance based on standard digital photograph. This number is reported as a total score on a 0-100 scale, with 0 being poor incision healing and 100 being excellent incision healing.|35 days (+/- 14 days)||||units on a scale||Standard Deviation|Mean
2609593|NCT02064231|Primary|Degree of Leakage|Degree of leakage is measured on a 24 point scale where 0 represents no leakage (best possible outcome) and 24 represents leakage on the whole plate (worst possible outcome).|14 days||||units on a scale|baseplates|Standard Deviation|Mean
2609594|NCT02064205|Secondary|Evaluate Effect of Pre-load on Satiety Hormones in Normal Weight and Overweight Women.|"The satiety hormones CCK, GLP-1, ghrelin and PYY are measured before (t=0) and after breakfast consumption (at t=30, 60, 90, 150, 240) . This is done on day 01, day 08, day 15 and day 22 with at least four days wash-out in-between.~The satiety hormones were only measured in the conditions when the pre-load was given with breakfast (condition A and B).~Area under the curves were calculated of the time curves."|Four hour curves (t=0, 30, 60, 90, 150 and 240 min) of day 01, day 08, day 15 and day 22.|Only in condition A and B blood was drawn and satiety hormones were analyzed.|||(mcg*min)/mL||Standard Deviation|Mean
2609595|NCT02064205|Secondary|The Appetite Suppressive Effect of Polydextrose During Meal Consumption (Satiation) and Satiety (After Food Consumption)|The appetite suppressive effect of polydextrose measured with Visual Analogue rating Scales (VAS). The AUCs were calculated for the scores obtained before - first score after meal intake (satiation) and for score after meal till start of next meal (in between meals, satiety). The VAS scores ranged from 0-100 for hunger and fullness (HUNGER: 0 = no hunger , 100 = very hungry; FULNESS: 0 = not full, 100 = very full)|one day||||mm*min||Standard Deviation|Mean
2609596|NCT02064205|Primary|Energy Intake at an ad Libitum Lunch on a Test-day in Normal Weight and Overweight Women.|Yogurt with a polydextrose (fiber with satiating effect) is consumed in the morning with breakfast or later in the morning. The satiating effect of the addition of polydextrose is tested on the amount of food consumed with lunch four hours or 1.5h later.|Four hours or 1.5 hour after consumption of a pre-load at up to day 22|Energy intake|||kJ||Standard Deviation|Mean
2609599|NCT02064166|Other Pre-specified|Unified Parkinson's Disease Rating Scale Part III (UPDRS Part III)|UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. The total score for subscale 3 ranges from 0 to 108 (the sum of scores from 14 items with 27 observations). The higher the value, the more severe the symptoms. The outcomes reflect the UPDRS Part III score at baseline and 4 weeks post treatment with post treatment scores compared to baseline in the insulin and placebo groups.|Baseline and post-treatment||||score on a scale||Standard Deviation|Mean
2609600|NCT02064166|Secondary|Beck Depression Inventory Score (BDI)|Beck Depression Inventory (BDI) is a 21-items self reported inventory with a scale evaluating depressive symptoms and the changes in BDI after treatment compared to baseline. The range of scores is 0 to 63, with higher scores indicating greater severity of depression.|Baseline and post-treatment||||score on a scale||Standard Deviation|Mean
2609601|NCT02064166|Secondary|Cognitive Impairment Using Montreal Cognitive Assessment (MoCA)|The Montreal Cognitive Assessment (MoCA) is a one-page 30-point test administered in approximately 10 minutes and is used to assess symptoms of cognitive impairment and their changes after treatment as compared to baseline. MoCA scores range between 0 and 30 with higher scores indicative of better cognitive performance. A score of 26 and above is considered to be normal.|Baseline and post-treatment||||score on a scale||Standard Deviation|Mean
2609602|NCT02064166|Secondary|Modified Hoehn and Yahr Scale|The modified Hoehn and Yahr Scale (HY) is used to assess severity of Parkinson Disease and treatment response post treatment as compared to baseline. The scale ranges from 1 to 5. The lower score indicates better outcome, e.g. less severe parkinsonism.|Baseline and post-treatment||||score on a scale||Standard Deviation|Mean
2609603|NCT02064166|Primary|Change in Verbal Fluency FAS (F, A or S Words) Total Score|Changes in Verbal Fluency FAS (a total number of F, A or S words) generated after 4 weeks of treatment compared to baseline, FAS total score is a sum of F,A, and S raw scores. The verbal fluency FAS test is used to assess phonemic fluency and verbal memory. Participants are asked to name words starting with letters F, A and S over one minute interval. The unit is a on scale, the normative data are adjusted for age and sex. The higher score means better verbal fluency.|Baseline and post-treatment||||Words||Standard Deviation|Mean
2609604|NCT02063880|Secondary|Number of Participants With Potential Drug Toxicity|Participants with adverse events that are deemed to be potentially related to medications.|6 months post-HAART initiation||||participants|||Number
2609605|NCT02063880|Secondary|Number of Participants With Evidence of Immune Reconstitution and Inflammatory Syndrome (IRIS)|Confirmed, possible or likely IRIS based on external independent review|6 months post-HAART initiation||||participants|||Number
2609606|NCT02063880|Primary|All-cause Mortality||6 months post-HAART initiation||||participants|||Number
2609607|NCT02063867|Post-Hoc|All-cause Bloodstream Infections Among Patients With Devices|Sub-population analysis: All-cause bloodstream infections attributable to participating units (defined as occurring >2 days into a participating unit stay through 2 days following unit discharge), among patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains). Includes bacterial and yeast pathogens. Skin commensals require two positive blood cultures.|21 months|Unadjusted intention-to-treat analysis of sub-population: patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains). Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)|||Hazard Ratio||95% Confidence Interval|Number
2609608|NCT02063867|Post-Hoc|VRE Clinical Cultures Among Patients With Devices|Sub-population analysis: Vancomycin-resistant enterococci (VRE) clinical cultures attributable to participating units (defined as occurring >2 days into a participating unit stay through 2 days following unit discharge), among patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains).|21 months|Unadjusted intention-to-treat analysis of sub-population: patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains). Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)|||Hazard Ratio||95% Confidence Interval|Number
2609609|NCT02063867|Post-Hoc|MRSA Clinical Cultures Among Patients With Devices|Sub-population analysis: Methicillin-resistant Staphylococcus aureus (MRSA) clinical cultures attributable to participating units (defined as occurring >2 days into a participating unit stay through 2 days following unit discharge), among patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains).|21 months|Unadjusted intention-to-treat analysis of sub-population: patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains). Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)|||Hazard Ratio||95% Confidence Interval|Number
2609610|NCT02063867|Post-Hoc|MRSA and VRE Clinical Cultures Among Patients With Devices|Sub-population analysis: Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) clinical cultures attributable to participating units (defined as occurring >2 days into a participating unit stay through 2 days following unit discharge), among patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains).|21 months|Unadjusted intention-to-treat analysis of sub-population: patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains). Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)|||Hazard Ratio||95% Confidence Interval|Number
2609611|NCT02063867|Other Pre-specified|Cost Effectiveness|Cost effectiveness of routine care vs decolonization|21 months|||||||
2609612|NCT02063867|Other Pre-specified|Emergence of Resistance to Chlorhexidine or Mupirocin|Emergence of resistance to chlorhexidine (among MRSA and select gram-negative bacteria) or mupirocin (among MRSA) for strains isolated from participating units|21 months|||||||
2609613|NCT02063867|Other Pre-specified|30-Day Infectious Readmissions|30-Day Infectious Readmissions among patients in participating units|21 months|||||||
2609614|NCT02063867|Other Pre-specified|Clostridium Difficile Infection|Clostridium difficile Infection attributable to participating units|21 months|||||||
2609615|NCT02063867|Other Pre-specified|Blood Culture Contamination|Blood culture contamination|21 months|||||||
2609618|NCT02063867|Secondary|Gram-negative Multi-drug Resistant Organism Clinical Cultures|Gram-negative (GN) multi-drug resistant organism clinical cultures attributable to participating units. Defined as occurring >2 days into a participating unit stay through 2 days following unit discharge|21 months|Unadjusted intention-to-treat analysis. Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)|||Hazard Ratio (Intervention vs Baseline)||95% Confidence Interval|Number
2609619|NCT02063867|Primary|MRSA and VRE Clinical Cultures|Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) clinical cultures attributable to participating units. Defined as occurring >2 days into a participating unit stay through 2 days following unit discharge|21 months|Unadjusted intention-to-treat analysis. Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)|||Hazard Ratio (Intervention vs Baseline)||95% Confidence Interval|Number
2609620|NCT02063854|Secondary|Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures)|New non-traumatic vertebral fractures were identified by interpretable X-ray images of 13 vertebrae from the fourth thoracic to the fourth lumbar vertebra. A Central Review Committee member for X-ray determined the presence or absence of new vertebral fractures, the number of new fractures, the presence or absence of worsening pre-existing vertebral fractures, and the number of worsened fractures. The assessment of new vertebral fractures and the worsening of pre-existing vertebral fractures was semiquantitative. The X-ray images were visually inspected and classified into normal (Grade 0), mild deformation (Grade 1), moderate deformation (Grade 2), or severe deformation (Grade 3). If the assessment of any vertebra became worse by at least 1 grade after starting the treatment, its height was measured. A new vertebral fracture or a worsening pre-existing vertebral fracture was concluded if the vertebra's height was reduced from the baseline by at least 20% and by at least 4 mm.|Baseline to Month 12|FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.|||percentage of participants|||Number
2609621|NCT02063854|Secondary|Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit|Urine samples for urine bone turnover markers were collected at specified visits according to the study schedule. Urine samples were to be collected at about the same time of the day, as far as possible, throughout the study. Urine NTX was corrected by creatinine value.|Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."|||percent change||Standard Deviation|Mean
2609622|NCT02063854|Secondary|Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit|Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.|Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."|||percent change||Standard Deviation|Mean
2609623|NCT02063854|Secondary|Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit|Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.|Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."|||percent change||Standard Deviation|Mean
2609624|NCT02063854|Secondary|Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit|Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.|Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."|||percent change||Standard Deviation|Mean
2609625|NCT02063854|Secondary|Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit|Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.|Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."|||percent change||Standard Deviation|Mean
2609626|NCT02063854|Secondary|Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit|The change in BMD in the femur (femoral neck) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."|||percent change||Standard Deviation|Mean
2609627|NCT02063854|Secondary|Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit|The change in BMD in the femur (trochanter) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."|||percent change||Standard Deviation|Mean
2609730|NCT02062632|Other Pre-specified|Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events, Radiation Therapy Oncology Group, and Patient Reported Outcomes (Continuation Phase)|Means and proportions, along with 95% confidence intervals and plots over time will be reported for adverse event levels by week.|Up to 3 months|||||||
2609628|NCT02063854|Secondary|Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit|The change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."|||percent change||Standard Deviation|Mean
2609629|NCT02063854|Secondary|Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit|The change in BMD in each vertebra, L2 to L4, and the averages of L2 to L4 at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)|"FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point."|||percent change||Standard Deviation|Mean
2609630|NCT02063854|Primary|Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) Measured by Dual Energy X-Ray Absorptiometry (DXA) at End of Study|The change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. DXA is a means of measuring BMD through x-ray.|Baseline and End of Study (up to Month 12)|Full Analysis Set (FAS), all randomized participants who received at least 1 dose of study drug, with data available for analyses.|||percent change||Standard Deviation|Mean
2609631|NCT02063737|Secondary|Intentions Subscale of the SFAB|An individual's intent to engage in behaviors that may promote improved alertness and reduced feelings of sleepiness or fatigue while at work with higher scores indicating greater intent. Range is 0 (strongly agree) to 100 (strongly disagree).|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
2609632|NCT02063737|Secondary|Habits Subscale of the SFAB|Endorsement of behaviors that may promote improved alertness and reduced feelings of sleepiness or fatigue while at work ranging from 0 (strongly agree) to 100 (strongly disagree). Strongly agree (lower score) is associated with high level of endorsement of behaviors (habits) that promote improved alertness.|end of study at the 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
2609633|NCT02063737|Secondary|Environmental Constraints Three Subscale of the SFAB|Degree of importance of personal/work-life barriers that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her responsibilities unrelated to the organization as factors that inhibit the individual's ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
2609634|NCT02063737|Secondary|Environmental Constraints Two Subscale of the SFAB|Degree of importance of employer policies that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her employer's policies and organizational related procedures/protocols as factors that inhibit the individual's ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
2609635|NCT02063737|Secondary|Environmental Constraints One Subscale of the SFAB|Degree of importance of employer based barriers that might limit ability to reduce feelings of fatigue and sleepiness while on duty. Scale ranges from 0 (not at all important) to 100 (very important). Higher scores indicate the individual perceives his/her employer's policies and organizational related procedures/protocols as factors that inhibit the individual's ability to engage in behaviors that can improve alertness and reduce feelings of sleepiness or fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
2609636|NCT02063737|Secondary|Importance Subscale of SFAB|Level of importance an individual places on the need to maintain alertness and reduce feelings of fatigue and/or sleepiness while at work ranging from 0 (strongly disagree) to 100 (strongly agree). Strongly agree (higher score) is associated with high level of importance (endorsement) placed on the need to maintain alertness and reduce feelings of fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
2609637|NCT02063737|Secondary|Knowledge-two Subscale of the SFAB|Perceived degree of evidence that fatigue and sleepiness at work increases risks to safety ranging from 0 (strongly disagree) to 100 (strongly agree). Higher scores indicate an individual has a high-level of awareness for the negative effects of sleepiness and fatigue while at work, that may be attributed to the acquisition of information, an increased understanding, or through experiences or education.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
2609638|NCT02063737|Secondary|Knowledge-one Subscale of SFAB|Perception that fatigue and sleepiness at work increases risks to safety ranging from 0 (strongly disagree) to 100 (strongly agree). Higher scores indicate an individual has a high-level of awareness for the negative effects of sleepiness and fatigue while at work, that may be attributed to the acquisition of information, an increased understanding, or through experiences or education.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
2609639|NCT02063737|Secondary|Self Efficacy Subscale of the SFAB|Degree of confidence from 0 (cannot do at all) to 100 (highly certain can do) for completing activities. Higher scores indicate the individual has a high-level of self-confidence he/she can perform select behaviors that may improve alertness and reduce feelings of sleepiness or fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
2609731|NCT02062632|Secondary|Patient Preference for Continued Therapy at Initial Dose and Crossover||At initial Day 1 dose and Day 3 crossover dose.|Only patients who submitted data on patient preference are evaluable for this outcome measure. Since none of the patients crossed over to the optional phase of the study, this secondary outcome could not be analyzed.||||||
2609640|NCT02063737|Secondary|Normative Beliefs Scale Two Subscale of the SFAB|Belief of people's views if they thought you were very fatigued mentally or physically while at work. Scale ranges from 0 (strongly approve) to 100 (strongly disapprove). Higher scores indicate a person believes the social norms and beliefs of his/her social network possess a negative view of behaviors that places an individual at work while very sleepy or fatigued.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
2609641|NCT02063737|Secondary|Normative Beliefs Scale One Subscale of the SFAB|Belief of people's views if they thought you were sleepy and fighting the urge to sleep while at work. Scale ranges from 0 (strongly approve) to 100 (strongly disapprove). Higher scores indicate a person believes the social norms and beliefs of his/her social network possess a negative view of behaviors that places an individual at work while very sleepy or fatigued.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
2609642|NCT02063737|Secondary|Attitudes Two Subscale of the Sleep Fatigue and Alertness Behavior Tool|Individual attitudes towards maintaining alertness and reducing fatigue at work on future shifts. Scale ranges from 0 to 100 with higher scores indicating a more positive/favorable attitude towards maintaining alertness and reducing fatigue while at work.|end of study at 90 day follow up|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
2609643|NCT02063737|Secondary|Attitude One Subscale of the Sleep Fatigue and Alertness Behavior (SFAB) Tool|Individual attitudes towards maintaining alertness and reducing fatigue at work. Scale ranges from 0 to 100 with higher scores indicating a more positive/favorable attitude towards maintaining alertness and reducing fatigue while at work.|Assessed at the end of 90-day study period|Intention to treat among participants with 90 day data (completers)|||units on a scale||Standard Deviation|Mean
2609644|NCT02063737|Primary|Self-Reported Fatigue at End of Shift Work|Self-reported fatigue based on scale ranging from 0 (Not At All) to 5 (Very Much).|At the end of scheduled work shifts during a 90 day study period|Analysis using intention to treat.|||units on a scale|Participants|Standard Error|Least Squares Mean
2609645|NCT02063724|Secondary|Occurrence of Treatment Related Adverse Events|Adverse Events reported as Related to Study Treatment, per adverse event category.|2 years|All participants.|||Participants|||Count of Participants
2609646|NCT02063724|Secondary|Immune Response|Number of participants with immune response. Participants will undergo leukapheresis after completion of 6 vaccines and 3 boost vaccines for the purpose of obtaining lymphocytes and monocytes for in vitro immunologic testing.|12 months|All participants.|||Participants|||Count of Participants
2609647|NCT02063724|Primary|Rate of Treatment Regimen Completion|Number of participants willing and able to complete treatment regimen, to address feasibility.|12 months|All participants.|||Participants|||Count of Participants
2609648|NCT02063698|Secondary|Location of New Pain Patient Had in the Last 24 Hours on Day 6 PIAPS Lower Arm Pain.|"Location of New Pain Patient had in the last 24 hours on day 6 PIAPS Lower arm pain. PIAPS question: Please indicate where any new pains are/were located by placing a check mark (√) next to the location. Please mark all that apply: The number of participants who completed this question on day 5 were analyzed (those who checked 'arm, between the elbows and wrists' are summarized by the 'Yes' row below and those who did not check 'arm, between the elbows and wrists' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used."|Up to 6 days||||Participants|||Count of Participants
2609649|NCT02063698|Secondary|Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Lower Arm Pain.|"Location of New Pain Patient had in the last 24 hours on day 5 PIAPS Lower arm pain. PIAPS question: Please indicate where any new pains are/were located by placing a check mark (√) next to the location. Please mark all that apply: The number of participants who completed this question on day 5 were analyzed (those who checked 'arm, between the elbows and wrists' are summarized by the 'Yes' row below and those who did not check 'arm, between the elbows and wrists' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used."|Up to 5 days||||Participants|||Count of Participants
2609650|NCT02063698|Secondary|Location of New Pain Patient Had in the Last 24 Hours on Day 5 PIAPS Upper Arm Pain|"Location of New Pain Patient had in the last 24 hours on day 5 PIAPS Upper arm pain. PIAPS question: Please indicate where any new pains are/were located by placing a check mark (√) next to the location. Please mark all that apply: The number of participants who completed this question on day 5 were analyzed (those who checked 'arm, above the elbow' are summarized by the 'Yes' row below and those who did not check 'arm, above the elbow' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used."|Up to 5 days||||Participants|||Count of Participants
2609651|NCT02063698|Secondary|Gnawing Pain as Measure by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8|Gnawing Pain as measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 8. The PIAPS question 'Please place a check mark (√) by all appropriate words that could be used to describe any pain you have had in the last 24 hours'. The number of participants who completed this question on day 8 were analyzed (those who checked 'gnawing' are summarized by the 'Yes' row below and those who did not check 'gnawing' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.|Up to 8 days||||Participants|||Count of Participants
2609652|NCT02063698|Secondary|Cramp Pain as Measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5|Cramp Pain as measured by the Paclitaxel-Induced Acute Pain Syndrome (PIAPS) Symptom Summary on Day 5. The PIAPS question 'Please place a check mark (√) by all appropriate words that could be used to describe any pain you have had in the last 24 hours'. The number of participants who completed this question on day 5 were analyzed (those who checked 'cramping' are summarized by the 'Yes' row below and those who did not check 'cramping' are summarized by the 'No' row below. Those who did not complete the symptom summary are summarized by the 'Missing' row.) The chi-square test was used.|Up to 5 days||||Participants|||Count of Participants
2609908|NCT02060539|Secondary|Lens Movement|Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||units on a scale|Lenses|Standard Deviation|Mean
2609654|NCT02063698|Secondary|Normalized AUC for BPI Average Pain From the Modified BPI in the Last 24 Hours From Days 2 to 8|Normalized AUC for BPI Average pain from the modified BPI in the last 24 hours from days 2 to 8. On a scale of 0-100 with 100:Best QOL. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain on the average.' Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more pain. The AUC for this question was then calculated and ranged from 0-100, with higher scores corresponding to less/improved pain. The Equal Variance T-test will be used to compare the average AUC for worst pain between the two arms.|Up to 28 days||||score on a scale||Standard Deviation|Mean
2609655|NCT02063698|Primary|Area Under the Curve (AUC) Summary of Worst Pain in the Last 24 Hours From Days 2 to 8|Area under the curve (AUC) Summary of Worst Pain in the last 24 hours from days 2 to 8. On a scale of 0-100, with 100=Best QOL. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours.' Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more pain. The AUC for this question was then calculated and ranged from 0-100, with higher scores corresponding to less/improved pain. The Equal Variance T-test will be used to compare the average AUC for worst pain between the two arms.|Up to 8 days||||score on a scale * day||Standard Deviation|Mean
2609656|NCT02063698|Primary|Count/Percentage of Patients Who Report Having Experienced the Paclitaxel-induced Pain Syndrome (PIAPS) for One Week After Paclitaxel After Enrollment to the Current Trial, Assessed by the Modified Brief Pain Inventory Scale (BPI)|The primary endpoint is the per arm count/percentage of patients who report having experienced the PIAPS for one week after paclitaxel after enrollment to the current trial. Pain was assessed on the question 'Please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours'. The count of participants who report having experienced the PIAPS for one week after paclitaxel after enrollment to the current trial circling 'less than 4' and 'greater than or equal to 4' for each day between day 2 to day 8 are reported below. Modified Brief Pain Inventory (BPI) ranges from 0 to 10, with higher scores corresponding to more /worse pain. Fisher's Exact Test will be used to compare the frequency of patients who experienced PIAPS between the two arms.|Up to 28 days||||Participants|||Count of Participants
2609657|NCT02063672|Secondary|Percentage of Participants Without Any Target Limb Reinterventions|Any surgical intervention in the target limb.|1 month, 6 months, and 12 months|All participants with evaluable data|||Percentage of Participants||95% Confidence Interval|Number
2609658|NCT02063672|Secondary|Percentage of Participants Without Target Vessel Revascularizations (TVR)|A TVR is defined as a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel.|1 month, 6 months, and 12 months|All participants with evaluable data|||Percentage of Participants||95% Confidence Interval|Number
2609659|NCT02063672|Secondary|Percentage of Participants Without Minor Limb Amputation|Minor limb amputation is defined as amputation of a part of the foot below the ankle.|1 month, 6 months, and 12 months|All participants with evaluable data|||Percentage of Participants||95% Confidence Interval|Number
2609660|NCT02063672|Secondary|Percentage of Participants Without Major Limb Amputation|Major limb amputation is defined as amputation of the lower limb above the ankle.|1 month, 6 months, and 12 months|All participants with evaluable data|||Percentage of Participants||95% Confidence Interval|Number
2609661|NCT02063672|Secondary|Percentage of Participants Without All-Cause Death|Mortality from any cause.|1 month, 6 months, and 12 months|All participants with evaluable data|||Percentage of Participants||95% Confidence Interval|Number
2609662|NCT02063672|Secondary|Percentage of Participants Without Major Vascular Complications (≤30 Day)|Freedom from major vascular complications at 30 days follow-up|30 Days|All participants with evaluable data|||Percentage of Participants||95% Confidence Interval|Number
2609663|NCT02063672|Secondary|Change in Quality of Life From Baseline|"EQ-5D is a standardized tool to assess patient-reported mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, or slight, moderate, severe, or extreme problems. Patients choose the appropriate level in each of the 5 dimensions, which results in a 1-digit number for each dimension. The digits for the 5 dimensions are converted into a single EQ-5D™ index score based on a set of population-based preference weights. For the U.S. general population, possible EQ-5D™ index scores range from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. A downloadable scoring file is available at: https://www.ahrq.gov/rice/EQ5Dscore.htm.~The EQ VAS records a patient's self-rated health on a vertical visual analogue scale, where the endpoints are labeled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). A higher VAS value indicates a higher quality of life."|6 months and 12 Months|All participants with evaluable data|||units on a scale||Standard Deviation|Mean
2609664|NCT02063672|Secondary|Change in Walking Impairment Questionnaire From Baseline|"The Walking Impairment Questionnaire (WIQ) is a validated questionnaire that evaluates walking ability with a focus on walking distance, walking speed, and the ability to climb stairs. Participants answer each item on a Likert scale from 0 for unable to do to 4 for no difficulty, and each response is weighted based on the difficulty of the task. The overall score is determined by dividing the weighted answers by the maximum possible weighted score and multiplying by 100. The overall score ranges from 0-100 with lower scores indicating lower performance."|6 months and 12 months|All participants with evaluable data|||units on a scale||Standard Deviation|Mean
2609665|NCT02063672|Secondary|Change of Resting Ankle Brachial Index (ABI) From Baseline|The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium).|6 months and 12 months|All participants with evaluable data|||ratio||Standard Deviation|Mean
2609666|NCT02063672|Secondary|Change of Rutherford Classification From Baseline|The Rutherford classification is a clinical means of describing peripheral artery disease along a seven-stage scale, with stage 0 representing asymptomatic presentation and stage 6 representing severe ischemic ulcers or frank gangrene. A decrease in units on the scale represents improvement in clinical symptoms.|6 months and 12 months|All patients with evaluable data.|||units on a scale||Standard Deviation|Mean
2609732|NCT02062632|Secondary|Use of Alternative Analgesics|Subgroup analyses will be performed to determine differential effects within the two stratification factors.|Up to 4 hours after treatment|Only patients who submitted data on alternative analgesics are evaluable for this outcome measure. None of the patients provided information about alternative analgesics, so this secondary outcome could not be analyzed.||||||
2609667|NCT02063672|Secondary|Percentage of Participants With Sustained Clinical Benefit Compared to Baseline|Sustained clinical benefit is defined as an improvement in Rutherford Classification compared to baseline and freedom from target vessel revascularization. The Rutherford classification is a clinical means of describing peripheral artery disease along a seven-stage scale, with stage 0 representing asymptomatic presentation and stage 6 representing severe ischemic ulcers or frank gangrene. A decrease in units on the scale represents improvement in clinical symptoms.|6 months and 12 months|All participants with evaluable data|||Percentage of Participants||95% Confidence Interval|Number
2609668|NCT02063672|Secondary|Percentage of Participants Without Target Lesion Revascularization (TLR)|TLR is defined as any repeat revascularization procedure (percutaneous or surgical) of the original target lesion site.|6 months and 12 months|All participants with evaluable data.|||Percentage of Participants||95% Confidence Interval|Number
2609669|NCT02063672|Secondary|Percentage of Participants Without Clinically Driven Target Lesion Revascularization (TLR)|Clinically-driven TLR is defined as revascularization of the target vessel with evidence of target vessel diameter stenosis >50% determined by duplex ultrasound or angiography and new distal ischemic signs (worsening ABI or worsening Rutherford Category associated with the target limb or due to clinical symptoms), OR revascularization of a target vessel with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms.|6 months and 12 months|All participants with evaluable data.|||Percentage of Participants||95% Confidence Interval|Number
2609670|NCT02063672|Secondary|Percentage of Participants With Secondary Patency at 6 Months and 12 Months|Secondary patency is defined as the absence of Binary Restenosis as adjudicated by the blinded, independent core laboratory, independent of whether or not patency is re-established via an endovascular procedure.|6 months and 12 months|All participants with evaluable data.|||Percentage of Participants||95% Confidence Interval|Number
2609671|NCT02063672|Secondary|Percentage of Participants With Primary Patency at 6 and 12 Months|Primary Patency is defined as Freedom from CEC-adjudicated Clinically-Driven TLR and from Core laboratory-adjudicated Binary Restenosis. Binary restenosis is based on threshold Doppler peak systolic velocity ratio (PSVR) ≥ 2.5 (together with waveform analysis & color mosaic appearance) or based on angiographic ≥ 50% diameter stenosis (if angiography is performed although not required per protocol).|6 months and 12 months|All participants with evaluable data at each time point.|||Percentage of Participants||95% Confidence Interval|Number
2609672|NCT02063672|Secondary|Percentage of Participants With Procedural Success|Procedural Success is defined as attainment of ≤30% residual stenosis in the treatment area by independent core lab analysis without major adverse events (defined as occurrence of death, amputation of the target limb, or repeat revascularization of the target lesion) during the index procedure and through the hospital stay.|During the Index Procedure (90 mins)|All participants with evaluable data.|||Percentage of Participants||95% Confidence Interval|Number
2609673|NCT02063672|Secondary|Percentage of Participants With Technical Success|Technical success of the balloon procedure is defined as the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion and a successful withdrawal of the study system with the achievement of < 30% residual percent stenosis without deployment of a bail-out stent.|During the Index Procedure (90 mins)||||Percentage of Participants||95% Confidence Interval|Number
2609674|NCT02063672|Secondary|Percentage of Participants With Device Success|Device success is defined as, on a per device basis, the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system.|During the Index Procedure (90 mins)|All participants with evaluable data|||Percentage of Participants||95% Confidence Interval|Number
2609675|NCT02063672|Primary|Percentage of Participants Without Primary Safety Events|Primary Safety Events include: All Cause Perioperative (≤30 day) Death, Index Limb Amputation, Index Limb Reintervention and Index Limb Related Death at 1 Year|12 Months|All participants with 12-month evaluable data for the primary safety endpoint.|||Percentage of Participants||95% Confidence Interval|Number
2609676|NCT02063672|Primary|Percentage of Participants With Primary Patency at 1 Year|Primary patency is defined as freedom from clinically driven target lesion restenosis (TLR) and from Binary Restenosis.|12 Months|All subjects who completed a 12-Month follow-up visit|||Percentage of Participants||95% Confidence Interval|Number
2609677|NCT02063659|Secondary|Change From Baseline in the Number of Daily BMs Averaged Over the 12-Week Double-Blind Period, Among Participants Who Were Not Receiving SSA Therapy at Baseline|Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.|Baseline and 12 Weeks|Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.The Placebo arm is not included because all participants in the Placebo arm were receiving SSA therapy at Baseline.|||counts/day||Standard Deviation|Mean
2609678|NCT02063659|Secondary|Change in the Frequency of Rescue Short-acting, Somatostatin Analog (SSA) Used to Treat Carcinoid Syndrome Symptoms Averaged Across All Time-Points|The frequency (the number of times) the participant used rescue with SSA to control symptoms was recorded in a daily diary. The daily number of rescue treatments with SSA was averaged over the 12- week period. A negative change from Baseline (less use of SSA) indicates improvement.|Baseline and 12 weeks|Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.|||counts/day||Standard Deviation|Mean
2609679|NCT02063659|Secondary|Change From Baseline in Abdominal Pain Averaged Across All Time-Points|Participants recorded abdominal pain in a daily diary. Participants evaluated the level of any abdominal pain using an 11-point numeric rating scale, where: 0=no pain to 10=worst pain ever experienced. The average daily abdominal pain was averaged over the 12-week period. A negative change from Baseline indicates improvement.|Baseline and 12 Weeks|Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.|||score on a scale||Standard Deviation|Mean
2609748|NCT02062450|Primary|Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate)|The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.|2-year postoperative||||percentage of participants|||Number
2609680|NCT02063659|Secondary|Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points|Participants recorded the number daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.|Baseline and 12 Weeks|Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.|||counts/day||Standard Deviation|Mean
2609681|NCT02063659|Secondary|Change From Baseline in Stool Form/Consistency Averaged Across All Time-Points|Participants assessed stool form/consistency of a BM using the Bristol Stool Form Scale where: 1=hard lumps to 7=watery liquid. The daily scores were averaged over the 12-week period. A negative change indicates improvement.|Baseline and 12 Weeks|Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.|||score on a scale||Standard Deviation|Mean
2609682|NCT02063659|Secondary|Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks|Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.|Baseline and 12 weeks|Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.|||counts/day||Standard Deviation|Mean
2609683|NCT02063659|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Extension Period|An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.|First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 52.6 Weeks)|Safety population, defined as all participants who received at least one dose of study drug, was used for analysis.|||Participants|||Count of Participants
2609684|NCT02063659|Primary|Primary: Percent Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels|u5-HIAA is a standard test used in clinical practice to assess neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement.|Baseline and 12 Weeks|Participants from the Intent-to-treat population, all randomized participants, with data available for this endpoint were included in the analysis.|||percentage change of mg/24 hours||Standard Deviation|Mean
2609685|NCT02063659|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period|An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.|First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.1 Weeks)|Safety population, defined as all participants who received at least one dose of study drug, was used for analysis.|||Participants|||Count of Participants
2609686|NCT02063516|Other Pre-specified|Amount of Air Added to Keep Cuff Pressure 60cmH20.|The accuracy of the intrinsic cuff pressure indicator is assessed by documenting which colour band the indicator is displaying when inflated according to manufacturers instructions, and measuring the numeric cuff pressure at the same time with a standard analogue cuff pressure gauge. The manufacturer has documented what pressure range is meant to be indicated by each of three colour ranges.|30 minutes, 60 minutes, 90 minutes and 120 minutes||||ml||Standard Deviation|Mean
2609687|NCT02063516|Secondary|Anatomic Position|This will be determined fiberscopically via the airway tube over the full range of cuff volumes and at an intracuff pressure of 60 cm H2O.|5 min|"Fiber-optic scoring system:~1, clear view of vocal cord 2, Only arytenoids visible 3, Only epiglottis visible 4, No laryngeal structures visible"|||participants|||Number
2609688|NCT02063516|Primary|Oropharyngeal Seal Pressure|This will be measured over the full range of cuff volumes (0-40 ml) and at an intracuff pressure of 60 cm H2O.|5 min||||cmH2O||Standard Deviation|Mean
2609689|NCT02063230|Primary|Dose Normalized Cmax, Unbound Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose||||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2609690|NCT02063230|Primary|Dose Normalized AUC, Unbound Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose||||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2609691|NCT02063230|Primary|Dose Normalized Cmax, Total Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose||||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2609692|NCT02063230|Primary|Dose Normalized AUC, Total Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose||||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2609693|NCT02063230|Primary|Cmax of Total Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose|In the moderate group, 2 patients received Selumetinib 25mg and are not included here but are included in the Dose Normalised Cmax outcome measure|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2609694|NCT02063230|Primary|AUC (0 to Infinity) of Total Selumetinib||0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post dose|In the moderate group, 2 patients received Selumetinib 25mg and are not included here but are included in the Dose Normalised AUC outcome measure|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2609695|NCT02063217|Primary|Percent Increase From Mean Baseline (07:00 to 19:00) of Cerebrospinal Fluid (CSF) Amyloid Beta During Sleep Induction and Sleep Deprivation Between 01:00 and 11:00 From Baseline|Overnight (01:00 to 11:00) differences in CSF amyloid beta from baseline (07:00 to 19:00) between 1) sleep-deprived and control participants and 2) sleep-induced and control participants.|Baseline = 07:00 to 19:00; Intervention period = 01:00 to 11:00|Participants in good general health who had CSF collected every 2 hours for 36 hours while undergoing with sleep deprivation, sleep induction with drug, or control conditions.|||percent increase from mean baseline||Standard Error|Mean
2609696|NCT02063178|Secondary|The Relationship Between Self-weighing on Weight Loss|We will also evaluated the impact of self-weighing (using Body Trace e-scales) on weight loss outcomes.|12 month intervention||||spearman's rho correlation|||Number
2610329|NCT02057549|Secondary|Nausea Relief as Indicated by Number of Participants Not Requesting Additional Antiemetic Medication||1 hour after study medication given||||Participants|||Count of Participants
2609699|NCT02063178|Primary|Percent Weight Loss (Baseline to 12 Months)|The primary data analysis will adhere to the intention-to-treat principle and in the final analysis, the participants will be categorized according to their initial randomization. Investigators will be using the baseline weight as a covariate in the final primary model where the two arms will be compared in terms of the percentage of weight loss.|12 month intervention||||percent weight loss||Standard Deviation|Mean
2609700|NCT02063087|Secondary|Fidelity - Options for Care|We will measure the degree to which the intervention is implemented as intended in both intervention and control groups when reviewing the recordings. The recordings in the intervention group will serve as a measure of the fidelity with which the intervention was delivered as intended. We will use a checklist of elements present and absent for quantification of implementation.|Day 1|participants who consented to recording, and with a recording of sufficient quality to be scored|||Participants|||Count of Participants
2609701|NCT02063087|Secondary|Rate of Clinically Important Traumatic Brain Injury (ciTBI)|The investigators will assess safety by comparing the rate of ciTBI in each arm of the study. The investigators will define ciTBI as we did in the original PECARN study: death from TBI, intubation for more than 24 hours for TBI, neurosurgical procedure, or hospital admission of 2 nights or more associated with TBI on CT.|7-days||||Participants|||Count of Participants
2609702|NCT02063087|Secondary|Healthcare Utilization - Number of Tests Ordered Within 7 Days|The investigators will assess healthcare utilization for the subsequent 7-days after the ED visit. Healthcare utilization will include measures such as hospitalization, re-hospitalization, primary and specialty visits, and diagnostics including CT use which will be obtained via a health record review, review of itemized hospital charges on the UB-92 and UB-04 forms (summary billing statements), and parental report via the 7 day follow-up by the study coordinator. Outcomes are reported as number of tests or procedures per patient, categorized based on the Berenson-Eggers Types of Service (BETOS) codes.|7-days||||number of tests or procedures performed||Standard Deviation|Mean
2609703|NCT02063087|Secondary|Proportion of Children Who Undergo Head CT|The study coordinator will ascertain whether the child underwent head CT in real time and confirm the data by health record review.|Day 1 (anytime during the index emergency department visit)||||Participants|||Count of Participants
2609704|NCT02063087|Secondary|Parental Satisfaction|"The investigators will assess parents' satisfaction by comparing the number of patients who reported being strongly satisfied with their choice."|Day 1 (immediately after the clinical encounter)|Analysis limited to participants who completed a post-encounter survey|||"participants Strongly Satisfied"|||Number
2609705|NCT02063087|Secondary|Trust in the Physician|The investigators will measure parents' trust in their clinician using the validated Trust in Physician Scale (TPS). There are 9 items with a scale of 1-5, the items are subtracted by 1, summed, divided by 9 and then multiplied by 25. The scale ranges from 0-100 where higher values are reflective of higher levels of trust in their physician.|Day 1 (immediately after the clinical encounter)|Analysis limited to patients with complete data|||units on a scale||Standard Deviation|Mean
2609706|NCT02063087|Secondary|Decisional Conflict|The investigators will measure the degree of conflict patients experience related to feeling uninformed using the validated Decisional Conflict Scale (DCS). The 16 items of DCS are scored on a 0-4 scale; the items are summed, divided by 16 and then multiplied by 25. The scale is from 0-100 where higher scores are reflective of parental uncertainty about the choice.|Day 1 (immediately after the clinical encounter)|Analysis limited to participants with complete data.|||Units on a scale||Standard Deviation|Mean
2609707|NCT02063087|Secondary|Patient Engagement in the Decision-making Process|Using the OPTION validated scale, the investigators will measure the degree to which clinicians engage parents' in the decision making process. The OPTION scale will be assessed by having 2 observers independently review and score the video recordings of the encounter between the parent and the child's emergency department clinician. The OPTION scale is composed of 12 items with a value of 0-4; they are summed, divided by 48 and multiplied by 100. This creates a score that ranges from 0-100, where higher scores are reflective of a higher level of parental engagement.|Day 1 (during the ED visit)|Analysis limited to patients who consented to recording and had a recording of sufficient quality to analyze|||Units on a scale||Standard Deviation|Mean
2609708|NCT02063087|Primary|Assess Parents' Knowledge Regarding Their Child's Risk for a Significant Brain Injury|Knowledge will be measured by means of a post visit survey delivered immediately after the clinical encounter in the emergency department. The investigators will assess parents' knowledge regarding their child's quantitative risk for a significant brain injury, the pros and cons of head CT compared to active observation, and what signs and symptoms parents should watch for in the next 24-48 hours that should prompt a return visit to the ED. Each knowledge question will provide the parent(s) with three options to respond (True, False, or Unsure), and the parent(s) will receive a score of 1 for a correct response and 0 for an incorrect response and any response of 'Unsure' will be considered incorrect. An overall score will be calculated by summing the correct responses and dividing by the number of questions asked.|Day 1 (immediately after the clinical encounter)|Analysis limited to participants with complete data.|||Number of questions correct out of 10||Standard Deviation|Mean
2609709|NCT02063035|Secondary|Post-operative Blood Transfusions During Hospitalization|All units of blood transfused during the hospital stay after surgery were recorded. One red blood cell unit contains 300 to 360 mL of whole blood.|From end of surgery on Day 1 to end of hospital stay up to approximately 5 days||||units of blood||Inter-Quartile Range|Median
2609710|NCT02063035|Secondary|Hospital Length of Stay in Days|The number of days the participants stayed in the hospital after surgery was recorded.|From end of surgery on Day 1 to end of hospital stay up to approximately 2 weeks||||days||Inter-Quartile Range|Median
2609711|NCT02063035|Secondary|Blood Loss Volume Following Surgery|Blood loss following surgery was defined as the total amount of fluid collected from the drain in the wound site during the hospital stay.|From end of surgery on Day 1 to end of hospital stay up to approximately 5 days||||mL||Inter-Quartile Range|Median
2609749|NCT02062450|Primary|Number of Participants With an Implant Dislocation After Surgery|The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.|2-year postoperative|2 implants dislocations were reported in the 379 patients making up the Total Safety Population, of which 1 concerned a Primary surgery and the other concerned a Revision surgery. In both cases, orthopaedic reduction was performed without changing the implant.|||participants|||Number
2609712|NCT02063035|Primary|Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge|Blood loss was calculated from the difference between the level of hemoglobin at the preoperative appointment and the lowest level during the postoperative hospitalization period. Reported here is the change in hemoglobin level after surgery. A negative number indicates a reduction in hemoglobin level.|From preoperative appointment approximately one week before surgery to end of hospital stay up to approximately 5 days after surgery|Only participants, for whom both preoperative and postoperative time points were collected, are reported in this outcome measure.|||grams per deciliter (g/dL)||Inter-Quartile Range|Median
2609713|NCT02062905|Secondary|Conjunctival Redness|"Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; 0 = no redness)"|14 days post insertion||||units on a scale (0 - 4)||Standard Deviation|Mean
2609714|NCT02062905|Primary|Ocular Itching|"Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; 0 = no itching)"|14 days post insertion||||units on a scale (0 -4)||Standard Deviation|Mean
2609715|NCT02062879|Secondary|Median Pain Score|Median daily pain score measures on a visual analogue scale for pain, with a range of 0 to 10. Higher scored indicate worse pain.|Participants will be followed for their entire hospital stay, an expected average of 1 week||||scores on a scale||Inter-Quartile Range|Median
2609716|NCT02062879|Secondary|Breakthrough Daily Opioid Requirement|Breakthrough daily opioid requirement in milligrams of morphine equivalents/day|Participants will be followed for their entire hospital stay, an expected average of 1 week||||mg morphine equivalents/day||Inter-Quartile Range|Median
2609717|NCT02062879|Primary|Total Daily Opioid Requirement|Daily breakthrough opioid requirement plus non-breakthrough opioid use in milligrams of morphine equivalents|Participants will be followed for their entire hospital stay, an expected average of 1 week.||||mg morphine equivalents/day||Inter-Quartile Range|Median
2609718|NCT02062801|Secondary|Urgent Cesarean Delivery|Incidence of urgent cesarean delivery|Within 30 minutes of combined spinal epidural (CSE) placement||||participants|||Number
2609719|NCT02062801|Secondary|Tetanic (Sustained) Uterine Contraction (TUC)|Incidence of Tetanic (sustained) Uterine Contraction (TUC)|Within 30 minutes of combined spinal epidural (CSE) placement||||participants|||Number
2609720|NCT02062801|Primary|Early Profound Fetal Bradycardia|Incidence of early profound fetal bradycardia|Within 30 minutes of combined spinal epidural (CSE) placement||||participants|||Number
2609721|NCT02062710|Primary|Change in Cough Reflex Sensitivity to Capsaicin|increase in C5 (decrease in cough reflex sensitivity). Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.|2 hours after study drug administration||||log C5 (uM)||Standard Error|Mean
2609722|NCT02062658|Primary|Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale|Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.|2 weeks||||participants|||Number
2609723|NCT02062645|Secondary|SBP and DBP in Patients With High Sodium Intake at Week 4 and 8|Change in systolic and diastolic blood pressure measured in office from baseline at week 4 and 8.|At week 4 and 8|All patients received amlodipine/valsartan 160/5 mg daily at Day 0 and were up titrated to amlodipine/valsartan 160/10 mg daily at visit 2 (week 4) if their hypertension can not be controlled. The duration of treatment period was 8 weeks.|||mmHg||Standard Deviation|Mean
2609724|NCT02062645|Secondary|Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8|Control rate of BP is defined as blood pressure lower than 140/90 mmHg at office visits in patients with high sodium intake (>100 mEq/day)|At week 4 and 8|The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values|||Percentage of participants|||Number
2609725|NCT02062645|Secondary|Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8|Change in diastolic blood pressure measured in office from baseline at week 4 and week 8.|baseline, week 4, week 8|The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values|||mmHg||Standard Deviation|Mean
2609726|NCT02062645|Secondary|Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8|Change in systolic blood pressure measured in office from baseline at week 4 and 8.|baseline, week 4, week 8|The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values|||mmHg||Standard Deviation|Mean
2609727|NCT02062645|Primary|Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8|Control rate of BP defined as BP lower than 140/90 mmHg at office visits|At week 4 and 8|The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values|||Percentage of Participants|||Number
2609728|NCT02062632|Other Pre-specified|Quality of Life Using European Organization for Research and Treatment of Cancer Quality of Life-Lung Cancer 13 and Functional Assessment of Cancer Therapy-Lung|Comparative statistics will be used to explore the relationship between quality of life and radiation-induced thoracic toxicities. These analyses will include scatterplots, spearman correlations, t-tests and chi-square tests.|Up to 4 hours after treatment|||||||
2609729|NCT02062632|Other Pre-specified|Pain Levels (Continuation Phase)|Means and proportions, along with 95% confidence intervals and plots over time will be reported for pain levels by week.|Up to 3 months|||||||
2609733|NCT02062632|Secondary|Incidence of Any Grade 3 or Higher Adverse Events Using Common Terminology Criteria for Adverse Events (CTCAE)|Incidence of any grade 3 or higher adverse events using Common Terminology Criteria for Adverse Events (CTCAE). Number or patients reporting a grade 3 or higher adverse event according to CTCAE|Up to 4 hours after treatment|5 were accrued but only 3 provided data. Since only 1 patient was accrued & completed the study on 1 arm, patient confidentiality prevents the reporting of results per intervention. 2nd crossover was optional; none chose to crossover. The study results are only reported for the 1st study period (before crossover) & only for placebo intervention.|||Participants|||Count of Participants
2609734|NCT02062632|Primary|Change in Mouth Pain as Measured by Average Area Under the Curve Per Assessment|Average Area Under the Curve per assessment (aAUCpa) of pain for the first cycle of treatment. Scores are reported on a 0-100 scale, where 100=better outcome QOL. The aAUCpa is the average of each AUC between each sequential assessment. Patients will assess their pain at baseline and at 5, 15, 30, 60, 120, and 240 minutes after treatment. The AUC calculation is based on the assessment number (1,2,3,4,5,6) instead of the actual number of minutes (5,15,30,60,120,240). This results in an AUC measure that is the average pain score across all of the measurements and is not a function of the number of minutes from treatment. The area under the curve of these 6 time points will be adjusted by their baseline pain score. The pain scores at each time point are given equal weights in the AUC calculation and the AUC calculation does not use the number of minutes after treatment. Therefore, the AUC measurement scale is the same as the original pain score scale.|Baseline and 5, 15, 30, 60, 120, and 240 minutes after treatment on day 1|5 were accrued but only 3 provided data. Since only 1 patient was accrued & completed the study on 1 arm, patient confidentiality prevents the reporting of results per intervention. 2nd crossover was optional; none chose to crossover. The study results are only reported for the 1st study period (before crossover) & only for placebo intervention.|||units on a scale|||Number
2609735|NCT02062580|Secondary|Vaccine Immunogenicity|Percent of CD4+ T cells expressing Ki67 after stimulation in vitro with BCG.|6 weeks after BCG vaccination|Analysis population n is smaller than enrollment numbers as we calculated that that only 28 were needing in each arm to detect a difference.|||percentage of Ki67% CD4+ T cells||Inter-Quartile Range|Median
2609736|NCT02062580|Primary|T Cell Activation|Percentage of all CD4+ T cells expressing HLADR (NOT BCG-specific activation as in Tchakoute et al and as in secondary outcome). The n is smaller than the enrollment number as some participants were lost to follow-up, some were excluded due to HIV infection etc, and some samples did not have sufficient cells to analyse.|at 6 weeks||||percentage of CD4+ T cells||Inter-Quartile Range|Median
2609737|NCT02062502|Secondary|Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2||Up to 5 days after Vaccination 2|The analysis population is All Subjects as Treated with results after vaccination 2.|||Percentage of participants|||Number
2609738|NCT02062502|Secondary|Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1||Up to 5 days after Vaccination 1|The analysis population is All Subjects as Treated with results after Vaccination 1.|||Percentage of participants|||Number
2609739|NCT02062502|Secondary|Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2||Up to 42 days after Vaccination 2|The analysis population is All Subjects as Treated with results after vaccination 2|||Percentage of participants|||Number
2609740|NCT02062502|Secondary|Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1||Up to 42 days after Vaccination 1|The analysis population is All Subjects as Treated with results after Vaccination 1.|||Percentage of participants|||Number
2609741|NCT02062502|Secondary|Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)||Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days)|The analysis population is All Subjects as Treated with temperature data at the time of assessment.|||Percentage of participants|||Number
2609742|NCT02062502|Primary|Geometric Mean Titer of VZV Antibodies|Antibody titers were measured with gpELISA.|6 weeks (43 days) after vaccination 1|The analysis population is participants with seronegative antibody titer at baseline and postvaccination serology contributing to the per-protocol analysis.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2609743|NCT02062502|Primary|Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL||6 weeks (43 days) after vaccination 1|The analysis population is participants with a seronegative antibody titer at baseline and postvaccination serology contributing to the per-protocol analysis.|||Percentage of participants|||Number
2609744|NCT02062450|Primary|Implant Survivorship|Implant survivorship criteria was assessed by investigators during patients visits : is the implanted device still in place 2 years after surgery ? Negative answers were quantified.|2-year postoperative||||percentage of implants|||Number
2609745|NCT02062450|Secondary|Clinical Performance - HARRIS Score|"The HARRIS score is a physician questionnaire assessing hip pain, function and mobility on a total of 100 points, 100 being the maximum score. A result between 90 and 100 points is considered excellent, between 80 and 90 good, between 70 and 80 mediocre and less than 70 poor."|2-year postoperative||||percentage of partipants|||Number
2609746|NCT02062450|Secondary|Clinical Performance - HOOS Score|The HOOS (Hip disability and Osteoarthritis Outcome Score) is a patient questionnaire evaluating patients' feelings about their operated hip. It consists of 40 questions divided into 5 subgroups: pain, symptoms, daily living, quality of life, sports and recreational activities. Each category is scored on 100 points, 0 being the worse outcome and 100 the best outcome.|2 years postoperative||||units on a scale of 100||Standard Deviation|Mean
2609747|NCT02062450|Secondary|Clinical Performance - PMA Score|"Postel-Merle-d'Aubigné (PMA) score is known since 1954 and is a very widespread mean of evaluating the clinical function of the hip by the physician.~It contains three items: pain, function and hip mobility, each noted on 6 points (0 is the worst possible score and 18 is the best possible score) :~a score between 15 and 18 points is defined as good,~a score between 12 and 14 points is defined as average,~a score inferior to 12 is defined as bad"|2 years postoperative||||units on a scale||Standard Deviation|Mean
2609750|NCT02062437|Other Pre-specified|General Performance: Radiological Assessment.|"Radiological assessment is based on :~Cup radiological signs of osteolysis or radiolucencies.~Stem radiological signs of osteolysis or radiolucencies.~Ossifications according to Brooker classification from class I: Ossification around the hip joint. to class IV: shows apparent bone ankylosis of the hip. (i.e Class 0 = no ossification)~Other Radiological signs"|2-year Follow-up visit|Patients with X-ray data available|||participants|||Number
2609751|NCT02062437|Other Pre-specified|General Performance: Objective Clinical Score (PMA)|Postel Merle d'Aubigne (PMA) rating contains three items; pain, function and hip mobility; each noted 0 to 6 points (0 is the worst possible score and 18 is the best possible PMA score).|2-year follow-up visit|Within per protocol population, data were not complete to calculate the total PMA score for 3 patients at 2-year visit.|||score on a scale||Standard Deviation|Mean
2609752|NCT02062437|Secondary|General Performance: Mobility|"Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°).~Normal values (usually observed range of motions) are:~extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°).~Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion."|2-year Follow-up visit|80 patients were available but per-protocol some pre-operative data were not available for the analysis of mobilities|||Degrees||Standard Deviation|Mean
2609753|NCT02062437|Other Pre-specified|General Performance: Objective Clinical Score (PMA)|Postel Merle d'Aubigne (PMA) rating contains three items; pain, function and hip mobility; each noted 0 to 6 points (0 is the worst possible score and 18 is the best possible PMA score).|Baseline|Within per protocol population, data were not complete to calculate the total PMA score for 3 patients at 2-year visit.|||score on a scale||Standard Deviation|Mean
2609754|NCT02062437|Secondary|General Performance: Mobility|"Mobility of the hip is assessed by the maximum value in the range of motions, expressed in degrees (°).~Normal values (usually observed range of motions) are:~extension (from 0 to 30°), flexion (from 0 to 120°), abduction (from 0 to 45°), adduction (from 0 to 30°), external rotation (from 0 to 45°) and internal rotation (from 0 to 45°).~Higher values are the best and a negative value indicates that the patient(s) can't reach the minimum normal range of motion."|Baseline|80 patients were available but per-protocol some pre-operative data were not available for the analysis of mobilities|||Degrees||Standard Deviation|Mean
2609755|NCT02062437|Primary|Number of Participants With Adverse Events|"Surgical incidents.~Post-operative complications.~Failure and revisions analysis."|2-year follow-up visit|The total of 80 patients were seen for their 2-Year follow-up visit.|||participants|||Number
2609756|NCT02062398|Secondary|Clinical Success 6 Months Post Activation|Clinical success was further assessed by: Quality of life questionnaire (SF-36 Health Survey) SF-36 Health Survey Scores on a scale [0 - 100], higher values represent a better outcome.|1 Month, 3 Months, and 6 months post system activation|Only 12 out of 13 patients completed the study. Thus, safety analysis is given for 13 patients and the performance analysis report on 12 patients.|||score on a scale||Standard Error|Mean
2609757|NCT02062398|Secondary|Clinical Success 6 Months Post Activation|"Clinical success is defined as the effect of the BlueWind Reprieve System on the treatment of the following symptoms compared to baseline:~- Pain related medication consumption/day"|6 months post activation|Only 12 out of 13 patients completed the study. Thus, safety analysis is given for 13 patients and the performance analysis report on 12 patients.|||Participants|||Count of Participants
2609758|NCT02062398|Secondary|Clinical Success 6 Months Post Activation|"Clinical success at 6 months post activation was further assessed by:Short-form McGill pain questionnaire.~McGill pain questionnaire Scores on a scale Range [0-60] points, higher values represent a worse outcome."|1 Month, 3 Months, and 6 months post system activation|Only 12 out of 13 patients completed the study. Thus, safety analysis is given for 13 patients and the performance analysis report on 12 patients.|||score on a scale||Standard Deviation|Mean
2609759|NCT02062398|Primary|Pain Assessment by Visual Analogue Scale (VAS) as Compared to Baseline at 6 Months Post Activation|"VAS score assessment at baseline and follow up visits was performed in two ways;~Pain Diary VAS score- the analysis was based on the pain diary, processing the average daily VAS scores over seven consecutive days.~Point VAS score- the analysis was based on the VAS score measurement recorded during the baseline visit and following 30 minutes stimulation at all follow up visits.Pain assessment by Visual Analogue Scale (VAS) as compared to baseline, post system activation.~Visual Analogue Scale (VAS) for Pain Scores on a scale [0 - 10], higher values represent a worse outcome."|1 Month, 3 Months, and 6 months post system activation|Out of the 13 treated patients, one device was explanted approximately after 3 weeks of treatment. Thus, safety analysis is given for 13 patients and the performance analysis report on 12 patients.|||score on a scale||Standard Deviation|Mean
2609760|NCT02062398|Primary|The Incidence of System and/or Procedure Related Serious Adverse Events (SAEs).|The incidence of system and/or procedure related serious adverse events (SAEs) throughout the entire study period|6 months||||Participants|||Count of Participants
2609761|NCT02062385|Secondary|Percentage of Participants Seropositive to Diphtheria, Pertussis, or Tetanus Antigens|The percentage of participants seropositive to diphtheria, pertussis, or tetanus antigens was assessed. Seropositive was defined as the following: 1) anti-diphtheria antibody titers >=0.1 International Units (IU)/mL, 2) anti-tetanus antibody titers >=0.1 IU/mL, 3) antipertussis toxin antibody titers >=20 Enzyme-linked Immunosorbent Assay (ELISA) Units (EU)/mL, 4) anti-pertussis filamentous hemagglutinin (FHA) antibody titers >=20 EU/mL. This outcome was evaluated only in participants receiving concomitant administration of V260 and EPI.|Baseline and between 28 and 51 days after the third DTaP vaccination|Participants in the concomitant EPI groups who receive their scheduled doses of DTaP without intervening disease specific to the antigen before the blood sample collection postdose 3, adhere to the guidelines for administration of vaccine, and have valid values available for analysis within specified day ranges.|||Percentage of participants||95% Confidence Interval|Number
2609773|NCT02062294|Primary|Proportion of Patients Developing Cytomegalovirus (CMV) Disease Within 6 Months of Liver Transplantation Under Valcyte Prophylaxis|Participants with clinical manifestation of CMV disease within 6 months after liver transplantation under Valcyte prophylaxis were evaluated.|6 months|Per Protocol (PP) population comprised all 14 participants receiving Valganciclovir within 10 days post-transplantation for at least 70 days and for whom source data from the time period between liver transplantation until 6 months post-transplantation was available.|||participants|||Number
2609762|NCT02062385|Secondary|Percentage of Participants With Any Adverse Event|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the sponsor's product, is also an adverse event.|Up to 30 days after any dose of V260 or Placebo|All Subjects as Treated with safety follow-up|||Percentage of participants|||Number
2609763|NCT02062385|Secondary|Percentage of Participants Who Achieved Seroprotection Against Poliovirus Type 1, 2, or 3|The percentage of participants who achieved seroprotection against poliovirus Type 1, 2, or 3 was assessed. Seroprotection was defined as a neutralizing antibody titer >=1:8. This outcome was evaluated only in participants receiving concomitant administration of V260 and OPV.|Baseline and between 28 and 56 days after the third OPV vaccination|Participants in the concomitant EPI groups who receive their scheduled doses of OPV without intervening disease specific to the antigen before the blood sample collection postdose 3, adhere to the guidelines for administration of vaccine, and have valid values available for analysis within specified day ranges.|||Percentage of participants||95% Confidence Interval|Number
2609764|NCT02062385|Secondary|Number of Participants With Severe Rotavirus Gastroenteritis|The number of participants with severe rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms. Severe RVGE was defined as >=11 on the Vesikari Scoring System, a composite of the seven parameters related to symptoms and treatment with an overall range from 0 to 20.|From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)|Participants who were vaccinated in either the staggered EPI or concomitant EPI groups, were not protocol violators, and were classified as evaluable for RVGE according to the per-protocol case definition.|||Participants|||Number
2609765|NCT02062385|Secondary|Percentage of Participants With Intussusception|Episodes of intussusception were collected from the time of written consent until the end of study. The percentage of participants with an episode of intussusception was assessed.|Up to 15 months|All Subjects as Treated with safety follow-up|||Percentage of participants|||Number
2609766|NCT02062385|Secondary|Percentage of Participants With Vomiting or Diarrhea|Episodes of vomiting and diarrhea were noted by the guardian and recorded on the Vaccination Record Card during Day 1 to Day 14 after each dose of vaccination. Vomiting and diarrhea reported by the guardian were also collected as an adverse event during Day 15 to Day 30 after any dose of vaccination. The percentage of participants with an episode or an adverse event of vomiting or diarrhea was assessed.|Up to 30 days after any dose of V260 or Placebo|All Subjects as Treated with safety follow-up|||Percentage of participants|||Number
2609767|NCT02062385|Secondary|Percentage of Participants With Elevated Temperature|Elevated temperature (temperature >=37.5°C axillary or equivalent) was noted by the guardian and recorded on the Vaccination Report Card during Day 1 to Day 14 after each dose of vaccination. Elevated temperature reported by the guardian was also collected as an adverse event (pyrexia) during Day 15 to Day 30 after each dose of vaccination. The percentage of participants with axillary temperature >=37.5 °C or an adverse event of pyrexia was assessed.|Up to 30 days after any dose of V260 or Placebo|All Subjects as Treated with follow-up specific to the endpoint|||Percentage of participants|||Number
2609768|NCT02062385|Primary|Number of Participants With Any Severity of Rotavirus Gastroenteritis|The number of participants with rotavirus gastroenteritis (RVGE) caused by naturally-occurring wild-type rotavirus (regardless of serotype or disease severity) was assessed. The case definition of RVGE included 1) 3 or more watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting, and 2) naturally-occurring wild-type rotavirus must be detected in a stool specimen taken within 7 days after the onset of symptoms.|From 14 days after the third dose of V260 or placebo through the first rotavirus season (up to 15 months)|Participants who were vaccinated in either the staggered EPI or concomitant EPI groups, were not protocol violators, and were classified as evaluable for RVGE according to the per-protocol case definition.|||Participants|||Number
2609769|NCT02062359|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|3 months||||participants|||Number
2609770|NCT02062359|Secondary|Persistence of Genetically Engineered, Adoptively Transferred Cluster of Differentiation 62L (CD62L) + Derived Lymphocytes|Estimate the persistence of cells via enzyme linked immunosorbent spot (ELISPOT) and tetramer analysis by fluorescence activated cell sorting (FACS).|3 months|No data was collected or analyzed, thus we did not perform an evaluation of persistence for this trial. The reason is that we did not accrue a sufficient number of patients in a timely manner. A minimum of 22 subjects was needed to perform an analysis.||||||
2609771|NCT02062359|Primary|Objective Response (Complete Response (CR) + Partial Response (PR)) of Melanoma Tumors|Response was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD) is at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|3 months|None of the participants achieved a complete response or partial response and no data were collected for this assessment.||||||
2609772|NCT02062294|Secondary|Number of Participants With Any Serious Adverse Events (SAEs) or Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|6 months|Safety Analysis population (SAP) comprised all 14 participants which entered study.|||participants|||Number
2609775|NCT02062177|Secondary|Time (Minutes) to Dischargeability of Patient From Endoscopic Unit|After endoscopy, patients will be transferred to recovery area and evaluated every 5 minutes until they will be ready to be discharged from the Endoscopy Unit. Recovery will be assessed using the Modified Aldrete Scoring System; patients will be considered fit for discharge with a Modified Aldrete Scoring System score of 18 or more, stable vital signs and without nausea, vomiting, or itching.|one day|||||||
2609776|NCT02062177|Primary|Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure|Patients will be contacted by telephone 24-72 hours after discharge and asked about their satisfaction about the quality of sedation, rated on a verbal rating scale, from 0 to 100 (0=dissatisfaction; 100=complete satisfaction)|at 24-72 hours after procedure||||units on a scale||Standard Deviation|Mean
2609777|NCT02062177|Primary|Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge|When completely awake, patients will be asked to rate the degree of pain/discomfort and the degree of satisfaction about quality of sedation from 0 to100 (0=dissatisfaction - 100=complete satisfaction)|before discharge||||units on a scale||Standard Deviation|Mean
2609778|NCT02062177|Primary|Endoscopist's Satisfaction (Visual Analog Scale) About Sedation|Visual Analog Scale from 0 to100 (0=dissatisfaction - 100=complete satisfaction) will be used to assess the technical difficulty of examination and the satisfaction with sedation of patient experienced by endoscopist|at the end of the exam||||units on a scale||Standard Deviation|Mean
2609779|NCT02062151|Primary|Percentage of Dislodged Needles||Within three days of placement||||percentage of needles|placed needles||Number
2609780|NCT02062151|Primary|Number of Participants With Skin Breakdown and / or Cellulitis||up to 57 days||||participants|||Number
2609781|NCT02061969|Secondary|Mortality|Mortality is defined as death occurring during admission at the LTC facility|over 6 months||||Participants|||Count of Participants
2609782|NCT02061969|Secondary|Incidence of Acute Kidney Injury|Acute kidney injury in LTC Residents Treated with Basal Insulin and Linagliptin Therapy|over 6 months||||events|||Number
2609783|NCT02061969|Secondary|Total Number of Complications|Total number of complications including urinary tract infections, pneumonia, diabetic foot infection, cardiac complications including myocardial infarction and heart failure, cerebrovascular accidents, and acute kidney injury and mortality.|6 months||||events|||Number
2609784|NCT02061969|Secondary|Total Number of Hospital Visits|Total number of hospital visits during the study period|6 months||||visits|||Number
2609785|NCT02061969|Secondary|Total Number of Emergency Room Visits|Total number of emergency room visits during the study period|6 months||||visits|||Number
2609786|NCT02061969|Secondary|Number of Participants With Acute Complications|Number of Participants with Acute Complications (urinary tract infections, pneumonia, bedsores, diabetic foot infection).|over 6 months||||Participants|||Count of Participants
2609787|NCT02061969|Secondary|Changes in Cognitive Function|Data on changes in cognitive function were not collected|over 6 months|Data were not collected||||||
2609788|NCT02061969|Secondary|Total Daily Dose of Insulin|Total daily dose of insulin (units)|over 6 months||||U/day||Standard Deviation|Mean
2609789|NCT02061969|Secondary|Number of Hypoglycemic Events < 40mg/dl|total number of severe hypoglycemia (< 40 mg/dl).|over 6 months||||events|||Number
2609790|NCT02061969|Secondary|Number of Hypoglycemic Events < 70mg/dl|total number of hypoglycemic events (<70 mg/dl)|over 6 months||||events|||Number
2609791|NCT02061969|Secondary|HbA1c|HbA1c at 6 month|6 months||||percent of glycosylated hemoglobin||Standard Deviation|Mean
2609792|NCT02061969|Primary|Mean Fasting Blood Glucose Level|The primary endpoint of the study is differences between treatment groups in mean fasting blood glucose level in LTC residents with poorly controlled diabetes.|6 months||||mg/dl||Standard Deviation|Mean
2609793|NCT02061774|Other Pre-specified|Total PCA Morphine|Amount of morphine used during surgery|Duration of operation||||mg||Inter-Quartile Range|Median
2609794|NCT02061774|Secondary|Vital Signs|Routine postoperative vital signs will be collected at 4-hour intervals (+/- 30 minutes) postoperatively respiratory rate, oxygen saturation, mean arterial pressure, and heart rate. Any reports of headache, dizziness, nausea, vomiting, pruritis, agitation, constipation, insomnia, bradycardia (Heart rate below 60 beats per minute), hypotension (MAP less than 30% of baseline), or urinary retention will be recorded throughout the study and will be treated appropriately as they occur, and the treatment medication will be stopped if determined to be a causative factor.|4-hour intervals (+/- 30 minutes) for 24-hrs averaged||||participants with 100% vitals completed|||Number
2609795|NCT02061774|Secondary|Sedation|Sedation will be measured on a scale of 1 to 5 at 4-hour intervals as follows: 1-completely awake; 2-awake but drowsy; 3 asleep, but responds to verbal commands; 4-asleep but responds to tactile stimuli; and 5-asleep and not responding to any stimuli.|4-hr intervals for a 24-hr period averaged||||participants of 100% sedation|||Number
2609796|NCT02061774|Primary|VAS|The Visual Analogue Scale (VAS) and Verbal Rating Scale (VRS) will be measured at 4 hour intervals for a 24-hr period - measures of pain intensity in clinical and research settings. 0-10 Numeric pain intensity scale. 0 is no pain, 5 is moderate pain, and 10 is worst possible pain|Q4 x 24 hours averaged||||score on a scale||Inter-Quartile Range|Median
2609797|NCT02061748|Secondary|All-cause Death (Post-hoc Analysis)|"This outcome measure describes the incidence of death for dabigatran and warfarin in the post-hoc analysis.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609853|NCT02061358|Secondary|CLr by Treatment Group: UV-4|CLr is the renal clearance, calculated at Ae(0-last) divided by AUC(0-last).|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing.L/h|||L/h||Geometric Coefficient of Variation|Geometric Mean
2609798|NCT02061748|Secondary|All-cause Death (Primary Analysis)|This outcome measure describes the incidence of death for dabigatran and warfarin in the primary analysis. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609799|NCT02061748|Secondary|Pulmonary Embolism (Post-hoc Analysis)|"This outcome measure describes the incidence of pulmonary embolism for dabigatran and warfarin in the post-hoc analysis.~Pulmonary embolism includes acute pulmonary heart disease. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609800|NCT02061748|Secondary|Pulmonary Embolism (Primary Analysis)|This outcome measure describes the incidence of pulmonary embolism for dabigatran and warfarin in the primary analysis. Pulmonary embolism includes acute pulmonary heart disease. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609801|NCT02061748|Secondary|Deep Vein Thrombosis (Post-hoc Analysis)|"This outcome measure describes the incidence of deep vein thrombosis for dabigatran and warfarin in the post-hoc analysis.~Deep vein thrombosis includes phlebitis and thrombophlebitis and other venous embolism and thrombosis.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609802|NCT02061748|Secondary|Deep Vein Thrombosis (Primary Analysis)|This outcome measure describes the incidence of deep vein thrombosis for dabigatran and warfarin in the primary analysis. Deep vein thrombosis includes phlebitis and thrombophlebitis and other venous embolism and thrombosis. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609803|NCT02061748|Secondary|Venous Thromboembolism (Post-hoc Analysis)|"This outcome measure describes the incidence of venous thromboembolism for dabigatran and warfarin in the post-hoc analysis.~Venous thromboembolism includes the deep vein thrombosis and the pulmonary embolism.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609804|NCT02061748|Secondary|Venous Thromboembolism (Primary Analysis)|"This outcome measure describes the incidence of venous thromboembolism for dabigatran and warfarin in the primary analysis. Venous thromboembolism includes the deep vein thrombosis and the pulmonary embolism.~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609805|NCT02061748|Secondary|MI (Post-hoc Analysis)|"This outcome measure describes the incidence of MI for dabigatran and warfarin in the post-hoc analysis.~MI includes the acute myocardial infarction. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609865|NCT02061358|Primary|Number of Subjects With Vital Sign Values of Toxicity Grade 1 or Higher Postdose by Treatment Group (Safety Population)|Number of subjects in a treatment group, who had a vital sign value of toxicity Grade 1 or higher: supine and standing systolic blood pressure (BP), supine and standing diastolic BP, supine and standing pulse rate, respiratory rate, and temperature|From time of the first dose administration through Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo|||Participants|||Number
2609806|NCT02061748|Secondary|Myocardial Infarction (MI) (Primary Analysis)|This outcome measure describes the incidence of MI for dabigatran and warfarin in the primary analysis. MI includes the acute myocardial infarction. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609807|NCT02061748|Secondary|TIA (Post-hoc Analysis)|"This outcome measure describes the incidence of TIA for dabigatran and warfarin in the post-hoc analysis.~TIA includes transient cerebral ischemia as the principal (primary) discharge diagnosis.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609808|NCT02061748|Secondary|Transient Ischemic Attack (TIA) (Primary Analysis)|"This outcome measure describes the incidence of TIA for dabigatran and warfarin in the primary analysis. TIA includes transient cerebral ischemia as the principal (primary) discharge diagnosis.~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609809|NCT02061748|Secondary|Other Major Bleeds (Post-hoc Analysis)|"This outcome measure describes the incidence of other major bleeds for dabigatran and warfarin in the post-hoc analysis.~Other major bleeds includes hemarthrosis, hemopericardium, hemoptysis, epistaxis, hemorrhage (not specified) and acute posthemorrhagic anemia.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609810|NCT02061748|Secondary|Other Major Bleeds (Primary Analysis)|"This outcome measure describes the incidence of other major bleeds for dabigatran and warfarin in the primary analysis. Other major bleeds includes hemarthrosis, hemopericardium, hemoptysis, epistaxis, hemorrhage (not specified) and acute posthemorrhagic anemia.~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609811|NCT02061748|Secondary|Major Urogenital Bleeding (Post-hoc Analysis)|"This outcome measure describes the incidence of major urogenital bleeding for dabigatran and warfarin in the post-hoc analysis.~Major urogenital bleeding includes hematuria and excessive/frequent menstruation and secondary diagnosis indicating acute bleeding (anemia).~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609812|NCT02061748|Secondary|Major Urogenital Bleeding (Primary Analysis)|"This outcome measure describes the incidence of major urogenital bleeding for dabigatran and warfarin in the primary analysis. Major urogenital bleeding includes hematuria and excessive/frequent menstruation and secondary diagnosis indicating acute bleeding (anemia).~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609813|NCT02061748|Secondary|Major Lower GI Bleeding (Post-hoc Analysis)|"This outcome measure describes the incidence of major lower GI bleeding for dabigatran and warfarin in the post-hoc analysis.~Major lower GI bleeding includes diverticulosis or diverticulitis of small intestine or of colon with hemorrhage, hemorrhage of rectum and anus, angiodysplasia of intestine with hemorrhage, blood in stool and hemorrhage of GI tract (unspecified).~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609814|NCT02061748|Secondary|Major Lower GI Bleeding (Primary Analysis)|"This outcome measure describes the incidence of major lower GI bleeding for dabigatran and warfarin in the primary analysis. Major lower GI bleeding includes diverticulosis or diverticulitis of small intestine or of colon with hemorrhage, hemorrhage of rectum and anus, angiodysplasia of intestine with hemorrhage, blood in stool and hemorrhage of GI tract (unspecified).~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609815|NCT02061748|Secondary|Major Upper GI Bleeding (Post-hoc Analysis)|This outcome measure describes the incidence of major upper GI bleeding for dabigatran and warfarin in the post-hoc analysis. Major upper GI bleeding includes acute, chronic or unspecified gastric ulcer, acute duodenal ulcer, chronic or unspecified duodenal ulcer, acute, chronic or unspecified peptic ulcer, acute, chronic or unspecified gastrojejunal ulcer with hemorrhage with/without (w/wo) obstruction and with hemorrhage and perforation w/wo obstruction, hematemesis, endoscopic control of gastric or duodenal bleeding, upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. This was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609816|NCT02061748|Secondary|Major Upper GI Bleeding (Primary Analysis)|This outcome measure describes the incidence of major upper GI bleeding for dabigatran and warfarin in the primary analysis. Major upper GI bleeding includes acute gastric ulcer, chronic or unspecified gastric ulcer, acute duodenal ulcer, chronic or unspecified duodenal ulcer, acute, chronic or unspecified peptic ulcer, acute gastrojejunal ulcer, chronic or unspecified gastrojejunal ulcer with hemorrhage with/without obstruction and with hemorrhage and perforation with/without obstruction, hematemesis, endoscopic control of gastric or duodenal bleeding, upper gastrointestinal endoscopy including esophagus, stomach, and either the duodenum and/or jejunum as appropriate with control of bleeding, any method. Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609817|NCT02061748|Secondary|Major GI Bleeding (Post-hoc Analysis)|"This outcome measure describes the incidence of major GI bleeding for dabigatran and warfarin in the post-hoc analysis. Major GI bleeding includes major upper GI bleeding and major lower GI bleeding.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609818|NCT02061748|Secondary|Major GI Bleeding (Primary Analysis)|"This outcome measure describes the incidence of major GI bleeding for dabigatran and warfarin in the primary analysis. Major GI bleeding includes major upper GI bleeding and major lower GI bleeding.~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609819|NCT02061748|Secondary|Major Extracranial Bleeding (Post-hoc Analysis)|"This outcome measure describes the incidence of major extracranial bleeding for dabigatran and warfarin in the post-hoc analysis. Major extracranial bleeding includes: major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609820|NCT02061748|Secondary|Major Extracranial Bleeding (Primary Analysis)|"This outcome measure describes the incidence of major extracranial bleeding for dabigatran and warfarin in the primary analysis. Major extracranial bleeding includes: major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding.~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2610330|NCT02057549|Secondary|Nausea Score as Measured by a Visual Analogue Scale (VAS)|The Visual Analogue Scale (VAS) ranges from 1-5, with 1 being minimal nausea and 5 being severe nausea.|1 hour after study medication given||||units on a scale||Standard Deviation|Mean
2609821|NCT02061748|Secondary|Major Intracranial Bleeding (Post-hoc Analysis)|"This outcome measure describes the incidence of major intracranial bleeding for dabigatran and warfarin in the post-hoc analysis. Major intracranial bleeding includes: Subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid, subdural or extradural hemorrhage following injury without mention of open intracranial wound other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if concomitant discharge diagnosis of major trauma was present.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609822|NCT02061748|Secondary|Major Intracranial Bleeding (Primary Analysis)|"This outcome measure describes the incidence of major intracranial bleeding for dabigatran and warfarin in the primary analysis. Major intracranial bleeding includes: Subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid, subdural or extradural hemorrhage following injury without mention of open intracranial wound other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if concomitant discharge diagnosis of major trauma was present.~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609823|NCT02061748|Secondary|Hemorrhagic Stroke (Post-hoc Analysis)|"This outcome measure describes the incidence of hemorrhagic stroke for dabigatran and warfarin in the post-hoc analysis. Hemorrhagic stroke includes: Subarachnoid hemorrhage and intracerebral hemorrhage but excludes these codes if traumatic brain injury or rehabilitation care as primary code is present.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609824|NCT02061748|Secondary|Hemorrhagic Stroke (Primary Analysis)|"This outcome measure describes the incidence of hemorrhagic stroke for dabigatran and warfarin in the primary analysis. Hemorrhagic stroke includes: subarachnoid hemorrhage, intracerebral hemorrhage but excludes these codes if traumatic brain injury or rehabilitation care as primary code is present.~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609825|NCT02061748|Secondary|Ischemic Stroke (Post-hoc Analysis)|"This outcome measure describes the incidence of ischemic stroke for dabigatran and warfarin in the post-hoc analysis. Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy.~A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609826|NCT02061748|Secondary|Ischemic Stroke (Primary Analysis)|"This outcome measure describes the incidence of ischemic stroke for dabigatran and warfarin in the primary analysis. Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy.~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609827|NCT02061748|Primary|Major Bleeding (Post-hoc Analysis)|This outcome measure describes the incidence of major bleeding (Inclusive of hemorrhagic stroke, major intracranial bleeding and major extracranial bleeding) for dabigatran and warfarin in the post-hoc analysis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609828|NCT02061748|Primary|Major Bleeding (Primary Analysis)|"This outcome measure describes the incidence of major bleeding (hemorrhagic stroke, major intracranial bleeding and major extracranial bleeding) for dabigatran and warfarin in the primary analysis.~Major Intracranial Bleeding includes subarachnoid hemorrhage, intracerebral hemorrhage, other and unspecified intracranial hemorrhage, subarachnoid hemorrhage following injury without mention of open intracranial wound, subdural hemorrhage following injury without mention of open intracranial wound, extradural hemorrhage following injury without mention of open intracranial wound, other and unspecified intracranial hemorrhage following injury without mention of open intracranial wound but excludes these codes if major trauma was present. Major extracranial bleeding includes major gastrointestinal (GI) bleeding, major urogenital bleeding and major other bleeding. Either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization were used."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609829|NCT02061748|Primary|Stroke (Post-hoc Analysis)|This outcome measure describes the incidence of stroke (hemorrhagic and ischemic) for dabigatran and warfarin in the post-hoc analysis. A post-hoc analysis was conducted that measured outcomes using an algorithm to define the principal diagnosis. The principal diagnosis was defined as the primary diagnosis on the first room and board charge record within a hospital admission. This method results in identification of a single outcome for a hospitalization.|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609830|NCT02061748|Primary|Stroke (Primary Analysis)|"This outcome measure describes the incidence of stroke (hemorrhagic and ischemic) for dabigatran and warfarin in the primary analysis.~Ischemic stroke includes: Occlusion and stenosis of precerebral arteries with cerebral infarction, Occlusion of cerebral arteries with cerebral infarction and Acute, but ill-defined, cerebrovascular disease but excludes above diagnosis if hospitalization lasted less than 48 hours and was accompanied by carotid endarterectomy.~Hemorrhagic stroke includes: Subarachnoid hemorrhage (SAH) and Intracerebral hemorrhage (ICH) but excludes previous listed diagnoses if traumatic brain injury or rehabilitation care is present.~Study outcomes for this analysis were identified using either the admitting diagnoses or on any of the service lines associated with an inpatient hospitalization."|From 1 October 2010 to 30 April 2013 identified with index date (first prescription of dabigatran or warfarin) plus a follow-up period of 12 months (up to 42 months)|A total of 7245 dabigatran and 14490 warfarin users remained after propensity score matching (PSM, 1:2) which was used to control for channelling bias.|||Events per 1000 patient-years||95% Confidence Interval|Number
2609831|NCT02061696|Secondary|Pain Score||Up to 37 days post procedure|Data not analyzed as the test device became unavailable and the study was terminated.||||||
2609832|NCT02061696|Secondary|Patient Satisfaction|Assessed by a patient satisfaction questionnaire.|Up to 37 days post procedure|Data not analyzed as the test device became unavailable and the study was terminated.||||||
2609833|NCT02061696|Secondary|Minor Access Site Related Complications|Observation of any minor access site related complications.|Up to 37 days post procedure|Data not analyzed as the test device became unavailable and the study was terminated.||||||
2609834|NCT02061696|Secondary|Ability to Sit up at 45-degree Angle|The ability to sit up at a 45-degree angle within 15 minutes of successful hemostasis without rebleed.|15 minutes of successful hemostasis|Data not analyzed as the test device became unavailable and the study was terminated.||||||
2609835|NCT02061696|Secondary|Time to Ambulation|Time from sheath removal until the participant can stand or walk 20 feet without rebleeding. Ambulation can be evaluated at 1,2, and 4 hours post sheath removal until the participant can ambulate.|Up to 1 day post procedure|Data not analyzed as the test device became unavailable and the study was terminated.||||||
2609836|NCT02061696|Secondary|Time to Actual Discharge|Time following procedural sheath removal until actual discharge.|Up to 1 day post procedure|Data not analyzed as the test device became unavailable and the study was terminated.||||||
2609837|NCT02061696|Secondary|Time to Discharge Eligibility|The time from sheath removal and ambulation to when a subject can be discharged after examination of access site.|Up to 1 day post procedure|Data not analyzed as the test device became unavailable and the study was terminated.||||||
2609838|NCT02061696|Secondary|Time to Hemostasis|Difference between the time the procedural sheath is removed and hemostasis is observed.|From procedural sheath removal until hemostasis is achieved.|Data not analyzed as the test device became unavailable and the study was terminated.||||||
2609839|NCT02061696|Secondary|AXERA 2 Access System Success|Achievement of femoral artery access with AXERA and placement of procedural sheath.|At the time of the femoral artey access procedure up to 1 hour post procedure|Data was not analyzed as the device became unavailable and the study was terminated.||||||
2609840|NCT02061696|Primary|Number of Participants With Any Site-Related Major Adverse Events|Observation of any major access site related complications (number of participants).|Up to 37 days post procedure||||Participants|||Count of Participants
2609841|NCT02061683|Secondary|Percentage of Patients With an Adverse Event of Conjunctival Hyperemia|Conjunctival hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|3 Months|Safety population defined as all enrolled patients who completed at least 1 follow-up visit|||Percentage of Patients|||Number
2609866|NCT02061358|Primary|Subjects With Serious Adverse Event (SAEs) by Treatment Group|Subjects with AEs considered serious by the investigator|From time of the first dose administration through Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo|||Subjects with at least 1 SAE|||Number
2609867|NCT02061358|Primary|Subjects With Treatment-emergent Adverse Event (TEAEs) by Treatment Group|TEAEs are those AEs occurring only after administration of investigational product|From time of the first dose administration through Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo|||Subjects with at least 1 TEAE|||Number
2609842|NCT02061683|Primary|Intraocular Pressure (IOP) in the Study Eye|IOP is a measure of the fluid pressure inside the study eye. Patients were categorized by pre-study therapies and the bimatoprost-containing study therapy into the following 5 groups: Group A (pre-study: treatment naïve; during study: bimatoprost monotherapy); Group B (pre-study: prostaglandin analog [PGA] monotherapy, excluding bimatoprost; during study: bimatoprost monotherapy); Group C (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost monotherapy); Group D (pre-study: combination therapy including PGA, without bimatoprost; during study: pre-study combination therapy with PGA switched to bimatoprost); and Group E (pre-study: non-PGA monotherapy or combination therapy; during study: bimatoprost adjunctive to pre-study therapy).|Month 3|All enrolled patients with data available for analysis|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2609843|NCT02061592|Primary|Monocular logMar Visual Acuity - Standard Low Contrast Bright|LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision. Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.|1- week Follow-up|Analysis population consisted of subjects that successfully completed all study visits without any major protocol deviations.|||LogMar|Eyes|Standard Deviation|Mean
2609844|NCT02061592|Primary|Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim|LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision.Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.|1-week follow-up|Consisted of subjects that successfully completed all study visits without any major protocol deviations. 13 Subjects were not included in the analysis population due to study procedures not properly followed from one of the investigational sites where the measured results were not collected in the lighting conditions described in the protocol.|||LogMar|Eyes|Standard Deviation|Mean
2609845|NCT02061592|Primary|Overall Vision|Subjective assessment of vision was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.|1- week Follow-up|Analysis population consisted of subjects that successfully completed the study visits without any major protocol deviations.|||units on a scale||Standard Deviation|Mean
2609846|NCT02061592|Primary|Overall Comfort|Subjective assessment of comfort was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens- wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.|1-week follow-up|Analysis population consisted of subjects that successfully completed the study visits without any major protocol deviations.|||units on a scale||Standard Deviation|Mean
2609847|NCT02061540|Other Pre-specified|Change From Baseline for Other Biochemical Markers of Cholestasis: Total Cholesterol, Low Density Lipoprotein Cholesterol|Total cholesterol (TC) level and low density lipoprotein cholesterol (LDLC) level were considered as biochemical markers of cholestasis.|Baseline, Week 14|mITT population included all participants who received at least 1 dose of investigational product and had at least 1 post baseline serum bile acid laboratory assessment.|||mg/dL||Standard Deviation|Mean
2609848|NCT02061540|Secondary|Change From Baseline in Pruritus as Measured by Adult Itch Reported Outcome (ItchRO) Weekly Sum Score|The Adult ItchRO instrument was completed twice daily using an electronic diary (eDiary). Each morning and evening score had a range from 0-10, with the higher score indicating increasing itch severity. The following was used for assessing the Adult ItchRO daily score: The score which represented the most severe itching for the day (morning or evening) was taken for each day as the daily score (maximum daily score of 10); If only 1 of the 2 scores was available for the day, the score that was available was used as the daily score; If both the morning and the evening scores were missing, the score was considered missing for the day.|Baseline, Week 14|mITT population included all participants who received at least 1 dose of investigational product and had at least 1 post baseline serum bile acid laboratory assessment.|||units on scale||Standard Deviation|Mean
2609849|NCT02061540|Secondary|Change From Baseline in Bilirubin Levels at Week 14|Total Bilirubin and Direct (Conjugated) Bilirubin levels were evaluated.|Baseline, Week 14|mITT population included all participants who received at least 1 dose of investigational product and had at least 1 post baseline serum bile acid laboratory assessment.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2609850|NCT02061540|Secondary|Change From Baseline in Liver Enzyme Levels in Serum|Levels of liver enzymes such as Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in serum were evaluated.|Baseline, Week 14|mITT population included all participants who received at least 1 dose of investigational product and had at least 1 post baseline serum bile acid laboratory assessment.|||units per liter (U/L)||Standard Deviation|Mean
2609851|NCT02061540|Primary|Change From Baseline in Fasting Serum Bile Acid Level at Week 14|Serum bile acid levels were evaluated using blood samples collected.|Baseline, Week 14|Modified intent-to-treat (mITT) population included all participants who received at least 1 dose of investigational product and had at least 1 post baseline serum bile acid laboratory assessment.|||micromoles per liter||Standard Deviation|Mean
2609852|NCT02061540|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An Adverse Event (AE) was defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered to be related to the investigational drug product. TEAEs were AEs with a start date on or after the first dose of investigational product and started prior to the last dose of investigational product plus 14 days.|From start of study drug administration until Week 18|Safety population included all participants who received at least 1 dose of the investigational product.|||participant|||Number
2609854|NCT02061358|Secondary|Interval and Cumulative Percent of UV-4 Excreted in Urine, fe, by Treatment Group|fe is the by-interval percentage of UV-4 drug excreted in urine. Intervals were 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose. fe = Ae/(UV-4B dose x 100). fe(0-12), fe(0-24) and fe(0-last) are the cumulative percentages of UV-4 drug excreted in urine over 24 hours and the entire collection period, respectively.|Pooled urine samples were collected at predose (-12 to 0 hour), and from 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.|||percentage of dose||Standard Deviation|Mean
2609855|NCT02061358|Secondary|Interval and Cumulative Amount (mg) of UV-4 Excreted in Urine, Ae, by Treatment Group|Ae is the by-interval and cumulative amounts of UV-4 drug excreted in urine. Intervals were 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose. Ae by-interval amounts were calculated as the product of urine volume and urine concentration. Ae(0-last) is the cumulative amount of UV-4 drug excreted in urine over the entire collection period, 48 hours. Cumulative amounts were calculated as the summation of the amounts excreted in collection intervals.|Pooled urine samples were collected at predose (-12 to 0 hour), and from 0 to 6, 6 to 12, 12 to 24, and 24 to 48 hours postdose|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B. Subjects in this population were used for all PK summaries.|||mg||Standard Deviation|Mean
2609856|NCT02061358|Secondary|t(1/2) by Treatment Group: UV-4|t(1/2) is the apparent terminal half-life, determined as ln(2)/λ(z).|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.|||hours||Full Range|Median
2609857|NCT02061358|Secondary|Vz/F by Treatment Group: UV-4|Vz/F is the apparent volume of distribution of UV-4 based on the terminal phase, calculated as dose (free-base equivalent) divided by [λ(z) × AUC(0-inf)].|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.|||L||Geometric Coefficient of Variation|Geometric Mean
2609858|NCT02061358|Secondary|CL/F by Treatment Group: UV-4|CL/F is the apparent systematic clearance, calculated as dose (free-base equivalent) divided by AUC(0-inf).|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2609859|NCT02061358|Secondary|AUC(0-inf) by Treatment Group: UV-4|AUC(0-inf) is the area under the concentration-time curve in the sample from pre-dose extrapolated to infinite time, calculated by linear up/log down trapezoidal summation and extrapolated to infinity by addition of the last quantifiable concentration divided by the apparent terminal rate constant: AUC(0-last) - C(last)/λ(z).|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B. Subjects in this population were used for all PK summaries.|||ng * h/mL||Geometric Coefficient of Variation|Geometric Mean
2609860|NCT02061358|Secondary|AUC(0-last) by Treatment Group: UV-4|AUC(0-last) is the area under the concentration-time curve from time zero (pre-dose) to time of last quantifiable concentration, calculated by linear up/log down trapezoidal summation.|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.|||ng * h/mL||Geometric Coefficient of Variation|Geometric Mean
2609861|NCT02061358|Secondary|Tmax by Treatment Group: UV-4|Tmax is the time of maximum concentration observed directly from the observed concentration versus time data.|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.|||hours||Full Range|Median
2609862|NCT02061358|Secondary|Cmax by Treatment Group: UV-4|Cmax is the maximum plasma concentration, obtained directly from the observed concentration versus time data.|Blood samples were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 18, 24, 36, and 48 hours postdose (1 hour window for predose)|The pharmacokinetic (PK) population consisted of all subjects who received active investigational product, UV-4B, and had at least 1 measured concentration at a scheduled PK time after start of dosing for UV-4B.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2609863|NCT02061358|Primary|Number of Subjects With Clinical Laboratory Test Results of Toxicity Grade 1 or Higher at Day 9 by Treatment Group|Number of subjects with Grade 1 toxicity or higher for hematology, coagulation, chemistry and urinalysis analytes. ULN=upper limit of normal; WBC=white blood cell count.|Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo|||Participants|||Number
2609864|NCT02061358|Primary|Number of Subjects With Electrocardiogram Outlier Values Postdose by Treatment Group|Number of subjects in a treatment group with outlier ECG findings: QTcF (Fridericia's), PR, and QRS intervals|From time of the first dose administration through Day 9 ± 1|Safety Population: all subjects who received any investigational product, UV-4B or placebo|||participants|||Number
2609885|NCT02061202|Secondary|Change in the Numerical Rating Scale (NRS) for Pain|Mean change in patient reported pain NRS score, full scale range 0- 10, higher score indicate more pain|baseline and 20 weeks||||score on a scale||Standard Deviation|Mean
2609868|NCT02061280|Secondary|Number of Errors in Questionnaires Completed by Participants at Visit 6 (Week 12).|"This outcome was to measure differences in timeliness and completeness of forms completed at home through REDCap in MICT participants compared with LASST participants.~No data were collected for this outcome. This is because in designing the REDCap database used to send questionnaires to the MICT trial participants and to store the responses from the completed questionnaires, data checks were put into place to prevent incomplete forms. We did this by requiring all fields to be completed before the questionnaire could be submitted. If a questionnaire was not submitted, the study coordinator re-sent the questionnaire to the participant and the questionnaire was completed during the FaceTime visit. For the LASST participants, the study coordinator reviewed all forms the participant completed at the study site visit and any incomplete fields were completed at the time of the study site visit."|Visit 6 (week 12)|No data were collected for this outcome.||||||
2609869|NCT02061280|Secondary|Number of Errors in Questionnaires Completed by Participants at Visit 5 (Week 6).|"This outcome was to measure differences in timeliness and completeness of forms completed at home through REDCap in MICT participants compared with LASST participants.~No data were collected for this outcome. This is because in designing the REDCap database used to send questionnaires to the MICT trial participants and to store the responses from the completed questionnaires, data checks were put into place to prevent incomplete forms. We did this by requiring all fields to be completed before the questionnaire could be submitted. If a questionnaire was not submitted, the study coordinator re-sent the questionnaire to the participant and the questionnaire was completed during the FaceTime visit. For the LASST participants, the study coordinator reviewed all forms the participant completed at the study site visit and any incomplete fields were completed at the time of the study site visit."|Visit 5 (week 6)|No data were collected for this outcome.||||||
2609870|NCT02061280|Secondary|Number of Errors in Questionnaires Completed by Participants at Visit 4 (Week 3).|"This outcome was to measure differences in timeliness and completeness of forms completed at home through REDCap in MICT participants compared with LASST participants.~No data were collected for this outcome. This is because in designing the REDCap database used to send questionnaires to the MICT trial participants and to store the responses from the completed questionnaires, data checks were put into place to prevent incomplete forms. We did this by requiring all fields to be completed before the questionnaire could be submitted. If a questionnaire was not submitted, the study coordinator re-sent the questionnaire to the participant and the questionnaire was completed during the FaceTime visit. For the LASST participants, the study coordinator reviewed all forms the participant completed at the study site visit and any incomplete fields were completed at the time of the study site visit."|Visit 4 (week 3)|No data were collected for this outcome.||||||
2609871|NCT02061280|Secondary|Number of Errors in Questionnaires Completed by Participants at Visit 3 (Week 0).|"This outcome was to measure differences in timeliness and completeness of forms completed at home through REDCap in MICT participants compared with LASST participants.~No data were collected for this outcome. This is because in designing the REDCap database used to send questionnaires to the MICT trial participants and to store the responses from the completed questionnaires, data checks were put into place to prevent incomplete forms. We did this by requiring all fields to be completed before the questionnaire could be submitted. If a questionnaire was not submitted, the study coordinator re-sent the questionnaire to the participant and the questionnaire was completed during the FaceTime visit. For the LASST participants, the study coordinator reviewed all forms the participant completed at the study site visit and any incomplete fields were completed at the time of the study site visit."|Visit 3 (week 0)|No data were collected for this outcome.||||||
2609872|NCT02061280|Secondary|Number of Errors in Questionnaires Completed by Participants at Visit 2 (Week -4).|"This outcome was to measure differences in timeliness and completeness of forms completed at home through REDCap in MICT participants compared with LASST participants.~No data were collected for this outcome. This is because in designing the REDCap database used to send questionnaires to the MICT trial participants and to store the responses from the completed questionnaires, data checks were put into place to prevent incomplete forms. We did this by requiring all fields to be completed before the questionnaire could be submitted. If a questionnaire was not submitted, the study coordinator re-sent the questionnaire to the participant and the questionnaire was completed during the FaceTime visit. For the LASST participants, the study coordinator reviewed all forms the participant completed at the study site visit and any incomplete fields were completed at the time of the study site visit."|Visit 2 (week -4)|No data were collected for this outcome.||||||
2609873|NCT02061280|Secondary|Number of Errors in Questionnaires Completed by Participants at Visit 1 (Week -8).|"This outcome was to measure differences in timeliness and completeness of forms completed at home through REDCap in MICT participants compared with LASST participants.~No data were collected for this outcome. This is because in designing the REDCap database used to send questionnaires to the MICT trial participants and to store the responses from the completed questionnaires, data checks were put into place to prevent incomplete forms. We did this by requiring all fields to be completed before the questionnaire could be submitted. If a questionnaire was not submitted, the study coordinator re-sent the questionnaire to the participant and the questionnaire was completed during the FaceTime visit. For the LASST participants, the study coordinator reviewed all forms the participant completed at the study site visit and any incomplete fields were completed at the time of the study site visit."|Visit 1 (week -8)|No data were collected for this outcome.||||||
2609874|NCT02061280|Secondary|Spirometry Quality Control Grade|"Spirometry grade scores in MICT participants (who performed spirometry at home) were compared with spirometry grade scores in LASST participants (who performed spirometry at the study sites). Spirometry grade scores were only available for LASST participants at Visit 3 (week 0), therefore only spirometry grade scores from Visit 3 were compared between MICT and LASST participants. Per the LASST trial no scoring was performed on the LASST participants for any other visit; the scoring for the LASST trial was for quality control only and was not a pre-specified trial outcome.~Spirometry grade score scale was: 4.00 (highest=best possible score), 3.00, 2.00, 1.00, 0.00 (lowest=worst possible score). The maximum score was 4.00, the minimum score was 0.00. Higher scores indicate better spirometry score and therefore better quality."|Visit 3 (week 0)|Twenty percent (20%) of available participant scores from Visit 3 (week 0) were randomly selected for analysis; N=11 participant scores were selected from the MICT Trial (20% of 54 scores =11). Eleven (11) participant scores were randomly selected from the LASST trial for analysis.|||scores on a scale||Inter-Quartile Range|Median
2609875|NCT02061280|Secondary|Asthma Control Test Score at Final Visit (Visit 6, Week12)|"The Asthma Control Test is a 5-item Likert scale questionnaire; Scaling of items 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled); The score for each item is summed to generate a total score. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.~The study was powered to have greater than 90% power to detect a clinically meaningful difference of 3 in the ACT score between the MICT Trial Design and the LASST trial Design , assuming a mean score of 19 with a standard deviation of 4 (data from a previous ALA-ACRC trial)."|Final Visit (Visit 6, Week 12)|The participant data set includes all participants who were randomized in each arm, the MICT trial design or LASST trial design. One participant in the MICT trial arm who was randomized to treatment at Visit 3 did not complete the study through Visit 6. The last available ACT score was used for this participant.|||scores on a scale||Inter-Quartile Range|Median
2609876|NCT02061280|Secondary|Asthma Control Test Scores at Screening (Visit 1, Week -8)|"The Asthma Control Test is a 5-item Likert scale questionnaire; Scaling of items 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled); The score for each item is summed to generate a total score. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.~The study was powered to have greater than 90% power to detect a clinically meaningful difference of 3 in the ACT score between the MICT Trial Design and the LASST trial Design , assuming a mean score of 19 with a standard deviation of 4 (data from a previous ALA-ACRC trial)."|Screening (Visit 1, week -8)|The participant data set includes all participants who were randomized in each arm, the MICT trial design or LASST trial design. One participant in the MICT trial arm who was randomized to treatment at Visit 3 did not complete the study through Visit 6. The last available ACT score was used for this participant.|||scores on a scale||Inter-Quartile Range|Median
2609877|NCT02061280|Secondary|Caregiver Research Participant Assessment Score at Study End (Visit 6, Week 12)|The Research Participant Assessment Score (RPA Comprehension) was a 17-item questionnaire designed to assess comprehension of study information at screening (Visit 6, week 12) between MICT and LASST trial designs. The same 17-item questionnaire was administered to the adolescent participant and to the caregiver participant. The items were scored as 1=incorrect, 2=partially correct, 3=correct (minimum possible score=17 and maximum possible score=51). Scores were assigned by two trained coders who independently listed to audio recordings of the RPA Comprehension questionnaire administration. Scores from the two coders were averaged for a final score. Higher scores indicate better comprehension. Mean (95% Confidence Interval) are the outcome measure reported.|Final Visit (Visit 6, Week12)|One participant in the MICT trial arm who was randomized to treatment at Visit 3 did not complete the study through Visit 6. Thus, the caregiver did not complete the Research Participant Assessment at Visit 6.|||Scores on a scale||95% Confidence Interval|Mean
2609878|NCT02061280|Secondary|Adolescent Research Participant Assessment Score at Study End (Visit 6, Week 12)|The Research Participant Assessment Score (RPA Comprehension) was a 17-item questionnaire designed to assess comprehension of study information at screening (Visit 6, week 12) between MICT and LASST trial designs. The same 17-item questionnaire was administered to the adolescent participant and to the caregiver participant. The items were scored as 1=incorrect, 2=partially correct, 3=correct (minimum possible score=17 and maximum possible score=51). Scores were assigned by two trained coders who independently listed to audio recordings of the RPA Comprehension questionnaire administration. Scores from the two coders were averaged for a final score. Higher scores indicate better comprehension. Mean (95% Confidence Interval) are the outcome measure reported.|Final Visit (Visit 6, Week12)|One participant in the MICT trial arm who was randomized to treatment at Visit 3 did not complete the study through Visit 6.|||Scores on a scale||95% Confidence Interval|Mean
2609879|NCT02061280|Primary|Caregiver Research Participant Assessment Score at Screening (Visit 1, Week -8)|The Research Participant Assessment Score (RPA Comprehension) was a 17-item questionnaire designed to assess comprehension of study information at screening (Visit 1, week -8) between MICT and LASST trial designs. The same 17-item questionnaire was administered to the adolescent participant and to the caregiver participant. The items were scored as 1=incorrect, 2=partially correct, 3=correct (minimum possible score=17 and maximum possible score=51). Scores were assigned by two trained coders who independently listed to audio recordings of the RPA Comprehension questionnaire administration. Scores from the two coders were averaged for a final score. Higher scores indicate better comprehension. Mean (95% Confidence Interval) are the outcome measure reported.|Screening (Visit 1, week -8)|One participant in the MICT trial arm who was randomized to treatment at Visit 3 did not complete the study through Visit 6. Thus, the caregiver did not complete the Research Participant Assessment at Visit 6.|||Scores on a scale||95% Confidence Interval|Mean
2609880|NCT02061280|Primary|Adolescent Research Participant Assessment Score at Screening (Visit 1, Week -8)|The Research Participant Assessment Score (RPA Comprehension) was a 17-item questionnaire designed to assess comprehension of study information at screening (Visit 1, week -8) between MICT and LASST trial designs. The same 17-item questionnaire was administered to the adolescent participant and to the caregiver participant. The items were scored as 1=incorrect, 2=partially correct, 3=correct (minimum possible score=17 and maximum possible score=51). Scores were assigned by two trained coders who independently listed to audio recordings of the RPA Comprehension questionnaire administration. Scores from the two coders were averaged for a final score. Higher scores indicate better comprehension. Mean (95% Confidence Interval) are the outcome measure reported.|Screening (Visit 1, week -8)|One participant in the MICT trial arm who was randomized to treatment at Visit 3 did not complete the study through Visit 6.|||Scores on a scale||95% Confidence Interval|Mean
2609881|NCT02061202|Secondary|Change in FEV1/FVC|Mean change in FEV1/FVC at 8 weeks compared to baseline|baseline and 8 weeks||||ratio||Standard Deviation|Mean
2609882|NCT02061202|Secondary|Change in Reticulocytes Count|Mean change in reticulocytes count - the number of new red blood cells.|baseline and 8 weeks||||10^3 cells/μL||Standard Deviation|Mean
2609883|NCT02061202|Secondary|Admissions or Visits to the Hospital|Number of times participant visited the Emergency Department (ED) or was admitted to the hospital|baseline through 8 weeks||||Events||Standard Deviation|Mean
2609884|NCT02061202|Secondary|Asthma Control Test|Asthma control test, total score from 0-25, with higher score indicating more symptoms|8 weeks||||score on a scale||Standard Deviation|Mean
2609887|NCT02061202|Secondary|Change in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me)|Mean changes in ASCQ-Me (NHLBI developed a patient-reported Sickle Cell Disease (SCD) quality of life measurement tool) pain impact, at week 20 as compared to baseline. A reduction change on a 100-point scale indicated improved quality of life. ASCQ-Me uses a T-score metric (0-100) in which 50 is the mean of the reference population and 10 is the standard deviation (SD) of that population.|baseline and week 20||||score on a scale||Standard Deviation|Mean
2609888|NCT02061202|Secondary|Change in Soluble Vascular Cell Adhesion Molecule (sVCAM) Level|Mean Change in effects of inhaled corticosteroids vascular injury, assessed by biomarker sVCAM as a surrogate for vascular injury.|Before ICS therapy begins and at 8 weeks post enrollment||||ng/mL||Standard Deviation|Mean
2609889|NCT02061202|Secondary|Change in Exhaled Nitric Oxide (eNO)|Change in effects of inhaled corticosteroids (ICS) as measured by exhaled nitric oxide levels, which is the primary marker of pulmonary inflammation.|Before ICS therapy begins and at 8 weeks post enrollment||||ppb||95% Confidence Interval|Mean
2609890|NCT02061202|Primary|Number of Participants Who Completed Follow up|Feasibility is determined by calculating the proportion of randomized participants who complete follow up and a minimum of 30 pain diaries with good adherence to the study medication vs. the number enrolled.|at 2 years||||Participants|||Count of Participants
2609891|NCT02060890|Other Pre-specified|Number of Participants Reaching 12 Months Progression Free Survival|Treatment efficacy derived from specialized Tumor Board suggestion, defined by 12 month progression free survival.|12 month progression free survival|Number of patients who chose to pursue treatment based on genomic informed recommendations|||Participants|||Count of Participants
2609892|NCT02060890|Other Pre-specified|Successful Generation of Patient-derived Xenograft (PDX) Genomic Models|Number of patient-derived xenograft (PDX) models successfully derived from patient tumor samples.|Within 12 months after tissue collection|Nine patients had sufficient tissue sent for PDX model development.|||Participants|||Count of Participants
2609893|NCT02060890|Secondary|Number of Patients Who Chose to Pursue Treatment|Number of patients who chose to pursue treatment based on these genomics-informed treatment recommendations|Within 35 days from surgery to making genomic informed treatment recommendation||||Participants|||Count of Participants
2609894|NCT02060890|Primary|Number of Participants Who Received Treatment Recommendations Within 35 Days of Surgery|To demonstrate feasibility, we would want the treatment recommendation to be fully complete within 35 calendar days in at least 85% of patients for which sufficient RNA and DNA is available.|35 days from surgery to making genomic informed treatment recommendation|16 pts had tumor tissue for analysis; 15 of 16 patients received treatment recommendations within 35 days of surgery.|||Participants|||Count of Participants
2609895|NCT02060838|Primary|Time to Platelet Aggregation as Measured Using Collagen-Adenosine (ADP)|The membrane of the cartridges are coated with collagen and adenosine diphosphate (ADP) inducing a platelet plug to form which closes the aperture.|Just prior to re-transfusion, assessed up to 5 minutes||||seconds||Inter-Quartile Range|Median
2609896|NCT02060838|Primary|Time to Platelet Aggregation as Measured Using Collagen-epinephrine (EPI)|The membrane of the cartridges are coated with collagen and epinephrine (EPI) inducing a platelet plug to form which closes the aperture.|Just prior to re-transfusion, assessed up to 5 minutes||||seconds||Inter-Quartile Range|Median
2609897|NCT02060539|Secondary|Average Wearing Time|"Participant response when asked, Number of hours worn today? (hours per day) Obtained at 2 weeks."|2 Weeks||||hours||Standard Deviation|Mean
2609898|NCT02060539|Secondary|Average Wearing Time|"Participant response when asked, Number of hours worn today? (hours per day) Obtained for habitual lens at baseline."|Baseline||||hours||Standard Deviation|Mean
2609899|NCT02060539|Secondary|Anterior Ocular Physiological Response|Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained at 2 weeks.|2 Weeks|Overall Conjunctival Staining (n=16), Overall Palpebral Papillae (n=8) Missing data as not all sites collected this data.|||units on a scale|Eyes|Standard Deviation|Mean
2609900|NCT02060539|Secondary|Anterior Ocular Physiological Response|Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained for habitual lenses at baseline.|Baseline|Overall Conjunctival Staining (n=16), Overall Palpebral Papillae (n=8) Missing data as not all sites collected this data.|||units on a scale|Eyes|Standard Deviation|Mean
2609901|NCT02060539|Secondary|Visual Acuity|Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at 2 weeks.|2 Weeks||||logMar||Standard Deviation|Mean
2609902|NCT02060539|Secondary|Visual Acuity|Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||logMar||Standard Deviation|Mean
2609903|NCT02060539|Secondary|Visual Acuity|Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained for habitual lenses at baseline.|Baseline||||logMar||Standard Deviation|Mean
2609904|NCT02060539|Secondary|Overall Fit Acceptance|Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at 2 weeks.|2 Weeks||||units on a scale|Lenses|Standard Deviation|Mean
2609905|NCT02060539|Secondary|Overall Fit Acceptance|Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||units on a scale|Lenses|Standard Deviation|Mean
2609906|NCT02060539|Secondary|Overall Fit Acceptance|Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained for habitual lenses at baseline.|Baseline||||units on a scale|Lenses|Standard Deviation|Mean
2609907|NCT02060539|Secondary|Lens Movement|Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at 2 weeks wear.|2 Weeks||||units on a scale|Lenses|Standard Deviation|Mean
2609909|NCT02060539|Secondary|Lens Movement - Habitual Lenses|Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained for habitual lenses at baseline.|Baseline||||units on a scale|Lenses|Standard Deviation|Mean
2609910|NCT02060539|Secondary|Lens Centration|Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at 2 weeks.|2 Weeks||||percentage of lenses|Lenses||Number
2609911|NCT02060539|Secondary|Lens Centration|Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at baseline at dispense.|Dispense||||percentage of lenses|Lenses||Number
2609912|NCT02060539|Primary|Overall Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.|2 Weeks||||percentage of participants|||Number
2609913|NCT02060539|Primary|Overall Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||percentage of participants|||Number
2609914|NCT02060539|Primary|Handling Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.|2 Weeks||||percentage of participants|||Number
2609915|NCT02060539|Primary|Vision Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.|2 Weeks||||percentage of participants|||Number
2609916|NCT02060539|Primary|Vision Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||percentage of participants|||Number
2609917|NCT02060539|Primary|Comfort Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.|2 Weeks||||percentage of participants|||Number
2609918|NCT02060539|Primary|Comfort Preference|Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||percentage of participants|||Number
2609919|NCT02060539|Primary|Overall Satisfaction of Comfort, Vision, Handling|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at baseline at 2 weeks.|2 Weeks||||units on a scale||Standard Deviation|Mean
2609920|NCT02060539|Primary|Overall Satisfaction of Comfort, Vision, Handling|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained habitual lens history at baseline.|Baseline||||units on a scale||Standard Deviation|Mean
2609921|NCT02060539|Primary|Overall Satisfaction of Comfort, Vision, Handling|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||units on a scale||Standard Deviation|Mean
2609922|NCT02060539|Primary|Handling (Insertion, Removal, Overall)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.|2 weeks||||units on a scale||Standard Deviation|Mean
2609923|NCT02060539|Primary|Handling (Insertion, Removal, Overall)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.|Baseline||||units on a scale||Standard Deviation|Mean
2609924|NCT02060539|Primary|Vision Quality (During Day and at Night)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at 2 weeks.|2 Weeks||||units on a scale||Standard Deviation|Mean
2609925|NCT02060539|Primary|Vision Quality (During Day)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||units on a scale||Standard Deviation|Mean
2609926|NCT02060539|Primary|Vision Quality (During Day and at Night)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained habitual lens history at baseline.|Baseline||||units on a scale||Standard Deviation|Mean
2609927|NCT02060539|Primary|Hazing (Blurred Edges)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained at 2 weeks.|2 Weeks||||units on a scale||Standard Deviation|Mean
2609928|NCT02060539|Primary|Hazing (Blurred Edges)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained habitual lens history at baseline.|Baseline||||units on a scale||Standard Deviation|Mean
2609929|NCT02060539|Primary|Ghosting (Multiple Images)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at 2 weeks.|2 Weeks||||units on a scale||Standard Deviation|Mean
2614831|NCT02006758|Secondary|Mean Change in Office Diastolic Blood Pressure at 12 Months||Baseline and 12 months|54 out of 67 participants analyzed for mean change in office Diastolic Blood Pressure at 12 months|||mmHg||Standard Deviation|Mean
2609930|NCT02060539|Primary|Ghosting (Multiple Images)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||units on a scale||Standard Deviation|Mean
2609931|NCT02060539|Primary|Ghosting (Multiple Images)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame ghosting. Cannot be worn. 100=No ghosting ever.) Obtained habitual lens history at baseline.|Baseline||||units on a scale||Standard Deviation|Mean
2609932|NCT02060539|Primary|Comfort (Insertion, End of Day, Overall)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.|2 Weeks||||units on a scale||Standard Deviation|Mean
2609933|NCT02060539|Primary|Comfort (Insertion)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||units on a scale||Standard Deviation|Mean
2609934|NCT02060539|Primary|Comfort (Insertion, End of Day, Overall)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.|Baseline||||units on a scale||Standard Deviation|Mean
2609935|NCT02060539|Primary|Dryness (During Day and Dryness at Night)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at two weeks.|2 Weeks||||units on a scale||Standard Deviation|Mean
2609936|NCT02060539|Primary|Dryness (During Day)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.|Dispense||||units on a scale||Standard Deviation|Mean
2609937|NCT02060539|Secondary|Lens Centration - Habitual Lenses|Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained for habitual lenses at baseline.|Baseline||||percentage of lenses|Lenses||Number
2609938|NCT02060539|Primary|Dryness (During Day and Dryness at Night)|Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained habitual lens history at baseline.|Baseline||||units on a scale||Standard Deviation|Mean
2609939|NCT02060526|Secondary|Maximum Observed Drug Concentration (Cmax) of Recombinant Human Heparan-N-Sulfatase (rhHNS) in Serum|Cmax of rhHNS in serum was evaluated using enzyme-linked immunosorbent assay (ELISA) method and liquid chromatography tandem mass spectrometry (LC-MS) method.|Predose, 0.5 h, 1 h, 2 h, 4 h, 8 h, 12 h, 24 h, and 48 h post-dose on Week 0 and Week 48|Pharmacokinetic (PK) population included all participants who received HGT-1410, participated in the scheduled PK studies, and had sufficient samples available for analysis.|||ng/ml||Standard Deviation|Mean
2609940|NCT02060526|Secondary|Concentration of Recombinant Human Heparan-N-Sulfatase (rhHNS) in Cerebrospinal Fluid (CSF)|Concentration of rhHNS in CSF was assessed using validated enzyme-linked immunosorbent assay (ELISA) method.|Pre-dose, 4, 48 hours on Week 0 and Week 48|Pharmacokinetic (PK) population included all participants who received HGT-1410, participated in the scheduled PK studies, and had sufficient samples available for analysis.|||nanogram per milliliter (ng/ml)||Standard Deviation|Mean
2609941|NCT02060526|Secondary|Change From Baseline in Concentration of GAG in Urine at Week 48|The concentration of GAG in urine was normalized to the urine creatinine value and reported as milligram (mg) GAG per millimole (mmol) creatinine.|Baseline (Week 0), Week 48|ITT population included all randomized participants.|||mg GAG/mmol creatinine||Standard Deviation|Mean
2609942|NCT02060526|Secondary|Change From Baseline in Concentration of Glycosaminoglycan (GAG) in Cerebrospinal Fluid (CSF) at Week 48|Change from baseline in concentration of GAG in CSF at Week 48 was reported.|Baseline (Week 0), Week 48|ITT population included all randomized participants.|||micromolar||Standard Deviation|Mean
2609943|NCT02060526|Secondary|Change From Baseline in Total Cortical Grey Matter Volume at Week 48|The change from baseline in grey matter volume at Week 48 was assessed by magnetic resonance imaging (MRI).|Baseline (Week 0), Week 48|ITT population included all randomized participants.|||cubic centimeter (cc)||Standard Deviation|Mean
2609944|NCT02060526|Secondary|Change From Baseline in Development Quotient (DQ) Using Bayley Scales of Infant Development Assessment Third Edition (BSID-III) at Week 48|The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The DQ is a means to express a neurodevelopmental/cognitive delay which was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range: 0, 100). The BSID--III DQ score is based on the cognitive domain. A positive value indicates improvement in health and cognition.|Baseline (Week 0), Week 48|ITT population included all randomized participants.|||percentage of chronological age||Standard Deviation|Mean
2609945|NCT02060526|Secondary|Change From Baseline in Vineland Adaptive Behavior Scales Second Edition (VABS-II) Development Quotient (DQ) Score at Week 48|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range, 0, 100). The overall DQ score is calculated from the mean age-equivalent score obtained by averaging out the age-equivalent scores for the all the sub-domains except for Gross and Fine motor skills. This test measures the following 5 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). A positive value indicates improvement in health and cognition.|Baseline (Week 0), Week 48|ITT population included all randomized participants.|||percentage of chronological age||Standard Deviation|Mean
2610102|NCT02058940|Secondary|Percentage of Hypoglycemic Episodes (<80 mg/dL)|Percentage of hypoglycemic episodes is calculated as the total number of glucose measurements <80 mg/dL for all patients/total number of glucose measurements collected for all patients.|Over 48 hours from infusion initiation||||percentage of measurements|||Number
2609946|NCT02060526|Secondary|Number of Participants With Positive Anti-recombinant Human Heparan-N-Sulfatase (rhHNS) Antibody in Serum at Week 48|A participant was considered positive if they had at least 1 positive result during the study. Once a participant reported antibody positive, they were considered positive for the remainder of the study.|Baseline (Week 0) up to Week 48|Safety population included all participants who received a dose of HGT-1410 using either the IDDD implantation or LP; underwent the IDDD surgical implant procedure without receiving a dose of HGT-1410; were randomly assigned to the untreated group and had any safety followup data.|||participants|||Number
2609947|NCT02060526|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product related. This included an exacerbation of a pre-existing condition. TEAEs were defined as AE occurring on or after the time of first IDDD implantation or LP procedure to the end of study (EOS) visit (+30 days).|Baseline (Week 0) up to Week 52|Safety population included all participants who received a dose of HGT-1410 using the IDDD implantation or LP; underwent the IDDD surgical implant procedure without receiving a dose of HGT-1410; were randomly assigned to the untreated group and had any safety follow-up data.|||participants|||Number
2609948|NCT02060526|Secondary|Number of Participants With Serious Adverse Events (SAE)|An adverse event (AE) was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product related. This included an exacerbation of a pre-existing condition. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline (Week 0) up to Week 52|Safety population included all participants who received a dose of HGT-1410 either using IDDD implantation or LP; underwent the IDDD surgical implant procedure without receiving a dose of HGT-1410; were randomly assigned to the untreated group and had any safety follow-up data.|||participants|||Number
2609949|NCT02060526|Primary|Number of Participants With Overall Response Using Bayley Scales of Infant Development Assessment Third Edition (BSID-III)|The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The development quotient (DQ) is a means to express a neurodevelopmental/cognitive delay which was computed as a ratio and expressed as a percentage using the age equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range: 0, 100). The BSID--III DQ score is based on the cognitive domain. A positive value indicates improvement in health and cognition. Overall response was the maximum decline in the DQ of 10 points or less over 48 weeks. Number of participants with the overall response were reported here.|Baseline (Week 0) up to Week 48|ITT population included all randomized participants.|||participants|||Number
2609950|NCT02060461|Primary|Evaluation of LASIK Flap Thickness|Central LASIK flap thickness for each femtosecond laser. Each treatment was set for a 110 micrometer thick flap.|3 months|Contralateral eyes|||micrometers|eyes|Standard Deviation|Mean
2609951|NCT02060383|Secondary|Percentage of Participants With ≤ 0.3% HbA1c Increase to End of Core Phase|Percentage of participants with ≤ 0.3% HbA1c increase in the incretin based therapy arm and the insulin arm.|Randomization, up to 16 weeks|Randomized Analysis Set (RAS): all participants who received at least one dose of pasireotide and were assigned to either incretin based therapy or insulin by randomization.|||Percentage of participants||95% Confidence Interval|Number
2609952|NCT02060383|Secondary|Absolute Change in FPG From Baseline to End of Core Phase|Absolute change in FPG from baseline to end of core phase in the incretin based therapy arm and the insulin arm.|Baseline, Up to 32 weeks (end of Core Phase)|Full Analysis Set (FAS): All participants who received at least one dose of pasireotide. Randomized patients were analyzed according to the anti-diabetic treatment assigned to at randomization. Non-randomized patients were analyzed by the anti-diabetic treatment received during the core phase (insulin at baseline, oral antidiabetics (OAD), none).|||mg/dL||Standard Deviation|Mean
2609953|NCT02060383|Secondary|Absolute Change in HbA1c From Baseline to End of Core Phase|Absolute change in HbA1c from baseline to end of core phase in the incretin based therapy arm and the insulin arm|Baseline, up to 32 weeks (end of Core phase)|Full Analysis Set (FAS): Participants who received at least 1 dose of pasireotide. Randomized participants were analyzed according to the anti-diabetic treatment assigned to at randomization. Non-randomized participants were analyzed by the anti-diabetic treatment received during the core phase (insulin at baseline, oral antidiabetics (OAD), none).|||HbA1c percentage||Standard Deviation|Mean
2609954|NCT02060383|Secondary|Percentage of Participants in the Incretin-based Arm Who Required Anti-diabetic Rescue Therapy With Insulin|The percentage of participants who received anti-diabetic rescue therapy in incretin based therapy is summarized.|Randomization to up to 16 weeks|Safety set - All participants randomized to the incretin-based therapy who received at least one dose of pasireotide and had at least one post-baseline safety assessment. Randomized participants within the safety set were analyzed according to the anti-diabetic study treatment first received.|||Percentage of participants||95% Confidence Interval|Number
2609955|NCT02060383|Secondary|Change in FPG (Fasting Plasma Glucose) From Randomization Until End of Core Phase|Absolute change in fasting glucose overtime from randomization (i.e. start of randomized antidiabetic treatment) to end of core phase per randomized arm|Randomization, R(randomization) Week 2, R-Week 4, R-Week 6, R-Week 8, R-Week 10, R-Week 12, R-Week 14, R-Week 16, end of Core phase|Randomized Analysis Set (RAS): all patients who received at least one dose of pasireotide and were assigned to either incretin based therapy or insulin by randomization.|||mg/dL||Standard Deviation|Mean
2609956|NCT02060383|Secondary|Change in HbA1c From Randomization (R) Over Time Per Randomized Arm|Absolute change in HbA1c overtime from randomization (i.e. start of randomized antidiabetic treatment) to end of core phase per randomized arm|Randomization (R), Week (W) 4 post R, W 8 post R, W 16 post R, end of Core phase (up to week 16 post R)|Randomized Analysis Set (RAS): all patients who received at least one dose of pasireotide and were assigned to either incretin based therapy or insulin by randomization.|||HbA1c percentage||Standard Deviation|Mean
2609957|NCT02060383|Primary|Change in HbA1c From Randomization to Approximately 16 Weeks|Absolute change in HbA1c from randomization to end of core phase (16 weeks) in incretin based therapy arm and insulin arm, and mean difference of change in HbA1c between the two treatment groups based on an ANOVA model using treatment (Incretin, Insulin) and the two randomization stratification factors (Disease: Cushing's disease vs Acromegaly; Baseline glycemic status: HbA1c <7% vs HbA1c ≥ 7%) as fixed effects. For Participants who discontinued the study or required rescue treatment before the time of assessing the primary endpoint, the last HbA1c assessment collected 8 weeks (56 days) after randomization (and prior to or on the date of start of rescue treatment) was carried forward. If the participant discontinued the study or used rescue treatment within 8 weeks after randomization, it was considered missing.|Randomization, 16 weeks|"Randomized Analysis Set (RAS): all patients who received at least one dose of pasireotide and were assigned to either incretin based therapy or insulin by randomization.~If the patient discontinued the study or used rescue treatment within 8 weeks after randomization, it was considered missing."|||Hba1c percentage||95% Confidence Interval|Mean
2609958|NCT02060370|Secondary|Changes in Circulating DNA Levels With Antiangiogenic Treatment||Not applicable due data not generated due to timing and budgetary issues|Data were not collected due to timing and budgetary issues.||||||
2609959|NCT02060370|Secondary|Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)|Participants completed FACT-G suveys evaluating quality of life at weeks 0, 12, 24, and 36. The score range is from 0 to 180 with higher scores reflecting a better quality of life. The results were reported for each time point for all participants and then broken into two groups: participants with a grade 3 toxicity and participants without a grade 3 toxicity. The total number of surveys changes as the weeks progress.|36 weeks from the start of treatment|The number of surveys collected at week 0, 12,24, and 36 are 54, 49, 44, and 35 surveys.The number of surveys with a grade 3 toxicity collected at week 0, 12, 24, and 36 are 14, 11, 12, and 10 surveys. The number of surveys without a grade 3 toxicity collected at week 0, 12, 24, and 36 are 40, 38, 32, and 25 surveys.|||Score on a scale||Full Range|Median
2609960|NCT02060370|Secondary|Dose Reductions and Treatment Discontinuations Due to Unacceptable Toxicities|Reported as the number and percentage of participants who underwent one or more dose reductions, as well as, the number and percentage of participants whose treatment ended.|2 years|Out of the 59 participants only 29 encountered a dose reduction. The number of dose reductions a participant experienced was also reported with the percentage being based on the 29 participants who had a reduction.|||Participants|||Count of Participants
2609961|NCT02060370|Secondary|The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event|Adverse events as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4|Participants were monitored for toxicities for 30 days after treatment was discontinued or until death, whichever occurred first.||||Participants|||Count of Participants
2609962|NCT02060370|Secondary|Progression-Free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|17 months||||months||95% Confidence Interval|Median
2609963|NCT02060370|Primary|Rate of Toxicity|Determine the number of participants who experience a specific, treatment-related adverse events at a grade three, four or five: fatigue, hand-foot syndrome, and/or diarrhea. Adverse events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4|Participants were monitored for toxicities for 30 days after treatment was discontinued; total treatment duration approximately 34 months||||Participants|||Count of Participants
2609964|NCT02060058|Other Pre-specified|The Other Responses in the mITT Population/Safty- HBV Virologic Response|HBV virologic response, defined as serum HBV DNA levels to < 200 IU/mL at follow-up week 24 among patients with detectable HBV DNA at baseline|week 24||||participants|||Number
2609965|NCT02060058|Secondary|Key Secondary Endpoint of This Clinical Trial-SVR in mITT|The total 7 patients had SVR by mITT in this clincial-trial, which is defined as undetectable HCV-RNA at follow-up Week 24 in subjects receiving ≥1 dose of Boceprevir|week 24|MITT population included subjects receiving ≥ 1 dose of boceprevir.|||participants|||Number
2609966|NCT02060058|Primary|Number of Full Analysis Set Participants Who Received HCV Anti-viral Therapy With Sustained Virological Response (SVR)|The methods used to assess this outcome measure is by full-analysis set (FAS), which is defined as undetectable HCV-RNA at follow-up Week 24 in subjects receiving ≥1 dose of any antiviral medication (Boceprevir/peginterferon/ribavirin)|week 24|"For survey the total 12 chronic hepatitis C patients by FAS in different arms in this clinical- trial.~Outcome Measure Data Table: For survey the total 8 chronic hepatitis C patients had SVR by FAS in different arms in this clinical- trial."|||participants|||Number
2609967|NCT02059993|Primary|Change of Daytime Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Pre-treatment and Post-treatment||baseline and follow-up at 36 months|4 participants withdrew before the end of study. Two subjects were lost to follow-up in the control group, and 4 patients (all of them had no SCCE) with very poor CPAP compliance were also excluded.|||mm Hg||Standard Deviation|Mean
2609968|NCT02059993|Other Pre-specified|Cardiovascular and Cerebrovascular Events||Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month|||||||
2609969|NCT02059993|Secondary|Change in Epworth Sleepiness Scale (ESS)||1 month，3 month，6 month，12 month，18 month，24 month，30 month，36 month|||||||
2609970|NCT02059993|Secondary|Change in Glucose and Lipid Metabolism||Baseline, 1 month, 3 month, 6 month, 12 month, 18 month, 24 month, 30 month, 36 month|||||||
2609971|NCT02059980|Secondary|Commission Errors on the Go/No-go Task.|The number of commission errors on the go/no-go task is a commonly used measure of response inhibition. In this task, participants are asked to withhold their responses on no-go trials. If they fail to withhold their response in a no-go trial (i.e., pressing the response key to the no-go signal), this response counts toward the total number of commission errors. Therefore, a greater number of commission errors on this task reflects a greater level of inhibitory control deficit.|Baseline, Week 4, and Week 8||||The number of commission errors||Standard Deviation|Mean
2610103|NCT02058940|Secondary|Percentage of Patients Requiring Rescue Insulin Infusion Protocol|Defined as the percentage of patients requiring an insulin infusion to control glucose concentrations during exenatide treatment|Over 48 hours from infusion initiation||||percentage of patients|||Number
2609972|NCT02059980|Secondary|Clinical Global Impression Severity and Improvement|The Clinical Global Impression Severity and Improvement (CGI) is a clinician-administered rating scale widely used to assess the overall severity of the target condition in treatment outcome research. The CGI is assessed on a 7-point scale, with the severity scale from 1 (Normal, not at all ill) through to 7 (Among the most severely ill patients). Thus, the higher CGI severity rating score indicate a greater level of overall illness.|Baseline, Week 4, and Week 8||||score on a scale||Standard Deviation|Mean
2609973|NCT02059980|Primary|Stop Signal Reaction Time|Stop Signal Reaction Time (SSRT; time taken to complete the inhibitory process) is estimated using the tracking algorithm on the computerized stop-signal task, which adjusts the stop signal delay automatically (by 50ms) to maintain the rate of successful inhibition on stop-signal trials at 50%.|Baseline, Week 4, and Week 8||||milliseconds||Standard Deviation|Mean
2609974|NCT02059980|Primary|Composite Score of Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) and National Institute of Mental Health (NIMH)|This is a clinician-administered rating scale of OCD symptom severity, most widely used in treatment outcome research for OCD, and a clinician-administered rating scale of hair pulling symptoms, widely used in clinical trial research for trichotillomania. Given the inclusion of two different diagnostic conditions, the primary outcome for the current study is the z score of the symptom rating severity obtained from the two rating scales, with higher values indicating greater symptom severity.|Baseline, Week 4, and Week 8|Intent to treat population (all participants who received at least one session of training with a pre-training assessment). Last observation carried forward (LOCF) imputation method.|||z scores||Standard Deviation|Mean
2609975|NCT02059928|Primary|Standardized Ratio as a Percentage Between Mean IOP and Mean Arterial Pressure|External cuff pressure readings were recorded every 15 minutes, and IO pressure data obtained via pressure transducer was recorded continuously for up to 12 hours. IO systolic, diastolic, and mean pressure (IO SBP, IO DBP, IO Mean) readings were summarized for the minute before and minute following an external cuff pressure reading. The ratios as a percentage of IO pressures to external cuff pressures (IO Systolic Blood Pressure / Cuff SBP; IO DBP / Cuff DBP; IO Mean / Cuff Mean) were calculated.|Up to 12 hour data collection period|Inclusion criteria included: age ≥ 18 year old, presence of an IO placed by EMS or in the Emergency Department, and planned admission to the Medical or Surgical Intensive Care Unit. Patients were excluded if they had anticipated surgery within 12 hours of IO placement, ongoing infection at the placement site.|||percentage of IO pressure to cuff pressu|||Number
2609976|NCT02059902|Primary|Narcotic Consumption (Measured in mg/kg Narcotic Consumption)|The infusion was initiated at 1.5mg/kg for 30 minutes prior to surgery start, followed by a 2.0 mg/kg/hr infusion at the time of incision start. The rate was reduced to 1.5mg/kg/hr for the remainder of the 24 hour period. A standardized post-operative pain management strategy (morphine and oxycodone) was followed by clinical staff, based on a standardized pain scale rating tool. The difference in narcotic consumption and number of pain medication doses over the 72-hour post-operative period was compared using an unadjusted Wilcoxon rank sum test due to non-normal data distribution.|24-hours post surgery||||mg/kg narcotic consumption||Inter-Quartile Range|Median
2609977|NCT02059642|Secondary|Safety Evaluation of Treatment on the Basis of Percentage of Participants With Treatment Emergent Adverse Events|Safety assessments will be based on changes from Baseline of clinical AEs reported by the subject or observed by the Investigator and concomitant medication use, treatment adherence (eg, dropouts due to AEs)|6 weeks|Safety population|||Percentage of participants with TEAEs|||Number
2609978|NCT02059642|Primary|Change in Total ADHD Symptom Score With Adult Prompts of the Conners Adult ADHD Rating Scale:O-SV in ADHD Adults From Baseline to 6 Weeks|Primary efficacy endpoint: change from Baseline in the total ADHD symptom score with adult prompts of the CAARS-Inv. The CAARS is a scale to assess the presence and severity of ADHD symptoms and behaviors in adults. During an interview with the investigator, subject rates items pertaining to their behavior using a 4-point Likert-style format ranging from 0 ('Not at all') to 3 ('Very much). The scale measures ADHD symptoms across clinically significant domains using a 30 item questionnaire, while examining the manifestations of those symptoms. The scale includes an assessment of 9 inattentive symptoms (Subset A) and 9 hyperactive & impulsive symptoms (Subset B). The total ADHD symptom score, Subset C (the sum of the inattentive symptom scores from Subset A and the hyperactive & impulsive symptoms from Subset B) is the primary outcome measure. Scores of the scale for Subset C, comprised of scores from 18 questions,range from 0 (no ADHD symptoms) to 54, highest rating of ADHD symptoms.|baseline, 6 weeks|Intent to Treat|||Change in Score from Baseline||95% Confidence Interval|Least Squares Mean
2609979|NCT02059434|Secondary|Area Under the Concentration-time Curve From Zero to the Time of the Last Measurable Concentration||Up to 36 hours after investigational product administration|Pharmacokinetic population: defined as all randomized subjects who received at least one dose of investigational product in at least one treatment period and have evaluable PK parameters|||pg.h/mL||Standard Deviation|Mean
2609980|NCT02059434|Secondary|Time to Maximum Observed Plasma Concentration (Tmax)||Up to 36 hours after investigational product administration|Pharmacokinetic population: defined as all randomized subjects who received at least one dose of investigational product in at least one treatment period and have evaluable PK parameters|||Hours||Full Range|Median
2609981|NCT02059434|Secondary|Maximum Observed Plasma Concentration (Cmax)||Up to 36 hours after investigational product administration|Pharmacokinetic population: defined as all randomized subjects who received at least one dose of investigational product in at least one treatment period and have evaluable PK parameters|||pg/mL||Standard Deviation|Mean
2609982|NCT02059434|Primary|Change From Baseline in Trough FEV1 (Forced Expiratory Volume in 1 Second)|Trough is defined as the mean of the FEV1 values obtained at 23 hours and at 24 hours after morning investigational product administration.|Day 2|Per Protocol Population: defined as all randomized subjects who satisfied the main inclusion / exclusion criteria, received investigational product, completed at least one treatment period, and did not present major violations to the protocol.|||Liters||Standard Deviation|Mean
2609997|NCT02059278|Secondary|Visual Acuity|Visual Acuity was measured using the Corrected Snellen Visual Acuity method reported as the Logarithm Minimum Angle of Resoution (logMAR) change from baseline. The Snellen eye chart was used with the subject's current corrected lens prescription at a distance equivalent to 20 feet. Results from the Snellen chart were converted to the logMAR scale which is the standard tool for reporting visual acuity outcomes.|Baseline and 84 days|Safety population defined as all randomized subjects who received at least one dose of the allocated study medication.|||logMAR units||Standard Deviation|Mean
2609983|NCT02059434|Primary|Subjects With ≥1 Treatment-emergent Adverse Event|Adverse events (AEs) are any unfavorable and unintended medical occurrence during the subject's participation in the study (including deterioration of a pre-existing medical condition, an abnormal value in a laboratory assessment, an ECG abnormality, a 12-lead 24-hour ECG-Holter abnormality, a blood pressure abnormal value, paradoxal bronchospasm or an abnormal finding in the physical examination) and will be coded using the current Medical Dictionary for Regulatory Activities (MedDRA).|30 Days|Safety Population: defined as all randomized subjects who received at least one dose of the investigational product|||Participants|||Number
2609984|NCT02059408|Other Pre-specified|Testing Cost|Reported by Primary Care Providers and pharmacists. Cost in dollars of testing and pharmacist time.|24 months|Not feasible to collect data for this outcome.||||||
2609985|NCT02059408|Other Pre-specified|Testing Time|Time in minutes to order and interpret tests. Reported by Primary Care Providers and pharmacists.|24 months|Data were not collected for this outcome. It was not feasible.||||||
2609986|NCT02059408|Secondary|ACE/ARB Prescription by a Clinician|New use by end of the study|12 months||||Participants|||Count of Participants
2609987|NCT02059408|Primary|Change in Blood Pressure|Change in blood pressure from enrollment to the end of the 12-month follow up period as a continuous outcome,|baseline, 12 months||||mmHg||Inter-Quartile Range|Median
2609988|NCT02059395|Primary|Skill Retention Estimated From the Change of AHA Heartsaver Total Score From Immediate Post-test to Retention Test|The official AHA Heartsave adult CPR AED Skill Sheet checklist for single-rescuer BLS was used to capture participants' skills for single-rescuer BLS and defibrillation with an AED. The AHA Heartsaver checklist has 11 action items, participant receives 1 point when an action on the checklist is performed. Therefore, the total score range from 0-11, with higher values represent a better outcome. Immediate post-test and retention test skill performance were evaluated by 2 independent raters. Skill retention was estimated by calculating the change in score from immediate post-test to retention test.|Baseline and 4 months||||units on a scale||Full Range|Mean
2609989|NCT02059291|Secondary|Percentage of Participants of Canakinumab Responders From Epoch 2 Who Maintained a Clinically Meaningful Response (Absence of New Flares) (40 Weeks)|A responder was defined as a participant who had no flare between week 16 and week 40.|40 weeks|The re-randomized set was analyzed.|||Percentage of participants|||Number
2609990|NCT02059291|Secondary|Percentage of Participants With Normalized Serum Amyloid A (SAA) Level|Normalized SAA was defined as SAA <= 10 mg/L.|16 weeks|The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed.|||Percentage of participants|||Number
2609991|NCT02059291|Secondary|Percentage of Participants With the Serologic Remission|Serologic remission was defined as C-reactive protein <= 10 mg/L.|16 weeks|The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed.|||Percentage of participants|||Number
2609992|NCT02059291|Secondary|Percentage of Participants Who Achieve Physician's Global Assessment (PGA) < 2|The PGA was evaluated by the investigator based on a 5-point scale: 0 = None (no) disease associated with clinical signs and symptoms; 1 = minimal disease associated signs and symptoms; 2 = mild disease associated signs and symptoms; 3 = moderate disease associated signs and symptoms; and 5 = severe disease associated signs and symptoms.|16 weeks|The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed.|||Percentage of participants|||Number
2609993|NCT02059291|Primary|Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks)|Resolution of the initial disease flare is defined as: Physician's Global Assessment of Disease activity (PGA) <2 and C-reactive protein (CRP) within normal range (<= 10 mg/L) or reduction by at least 70% from baseline. The PGA was evaluated by the investigator based on a 5-point scale: 0 = None (no) disease associated with clinical signs and symptoms; 1 = minimal disease associated signs and symptoms; 2 = mild disease associated signs and symptoms; 3 = moderate disease associated signs and symptoms; and 5 = severe disease associated signs and symptoms.|16 weeks|The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed.|||Percentage of participants|||Number
2609994|NCT02059278|Secondary|Mean Deviation in Visual Field|Visual Field was performed using an automated perimeter according to the sites standard protocol. This test measures the angle of the visual field from the central visual axis. Visual Field Testing generates a numerical scale as its main result which shows the retinal sensitivities at the different test locations, expressed in Decibels (dB). The mean deviation in the visual field reflects the overall depression (deviation from normal values). Negative values indicate a reduction in visual field. The analysis performed is the mean change from baseline at Day 84.|Baseline and 84 days|Safety population defined as all randomized subjects who received at least one dose of the allocated study medication.|||Decibels (dB)||Standard Deviation|Mean
2609995|NCT02059278|Secondary|Ophthalmoscopy|Number of participants with eye abnormalities following ophthalmoscopy. Direct ophthalmoscopy with dilation included assessment of the optic nerve head for pallor and cupping. A dilated fundus examination consisting of the vitreous, optic nerve, macula, and peripheral retina was conducted. Results are reported as the number of subjects with clinical significant abnormalities at Day 84 that were not clinically significant at Baseline.|Baseline and 84 days|Safety population defined as all randomized subjects who received at least one dose of the allocated study medication.|||Participants|||Count of Participants
2609996|NCT02059278|Secondary|Slit Lamp Examination|Number of participants with eye abnormalities following routine slit lamp examination. The anterior segment of the eye including lids, cornea, conjunctiva, anterior chamber, iris and lens were evaluated with a routine slit lamp examination and any abnormalities observed were reported.|Baseline and 84 days|Safety population defined as all randomized subjects who received at least one dose of the allocated study medication.|||Participants|||Count of Participants
2610017|NCT02059187|Secondary|Daily Basal Insulin Dose (Units) at Week 24|The daily basal insulin dose (measured in units) for any given visit is defined as the average dose from the three most recent days preceding the visit date.|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units||95% Confidence Interval|Least Squares Mean
2609998|NCT02059278|Primary|Intraocular Pressure|"Evaluation of intraocular pressure using Goldmann applanation tonometry.~Primary outcome was the between group difference in the change from baseline in IOP at each of 9 assessment points.~Equivalence was achieved if the 95% Confidence Intervals were within 1.5 mmHg at all 9 time points"|Measured at 8am 10 am and 4 pm at Baseline and on Days 15, 42 and 84|The Per Protocol population was the primary efficacy population and consisted of those subjects in the ITT population who had no major protocol violations and no missing data points|||mm Hg||Standard Deviation|Mean
2609999|NCT02059265|Other Pre-specified|ARID1A Mutation Status in Formalin-fixed, Paraffin Embedded Tissue Using Next-generation Exon-capture Sequencing|ARID1A mutation status will be tabulated to determine the correlation between BAF250a IHC and ARID1A mutations.|Up to 5 years|ARID1A information was available for 26 of 35 patients. Missing data is attributed to assay failure.|||Spearman Correlation Coefficient||95% Confidence Interval|Number
2610000|NCT02059265|Secondary|Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0|The frequency and severity of all toxicities are tabulated.|Up to 5 years||||Count of Participants with >= grade 3 AE|||Number
2610001|NCT02059265|Secondary|Duration of Progression-free Survival (PFS)|PFS will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.|Duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years||||Months||95% Confidence Interval|Median
2610002|NCT02059265|Secondary|Duration of Overall Survival (OS)|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.||||Months||95% Confidence Interval|Median
2610003|NCT02059265|Primary|Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1|Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression for up to 5 years.||||Participants|||Count of Participants
2610004|NCT02059213|Secondary|Frequency of Treatment Delay|Treatment delays will be reported to describe tolerability within each arm.|Up to 54 months|||||||
2610005|NCT02059213|Secondary|Frequency of Dose Modification|Dose modifications will be reported to describe tolerability within each arm.|Up to 54 months|||||||
2610006|NCT02059213|Secondary|Time to Clinical Progression|Clinical progression-free survival will begin from treatment start until the event of clinical progression or death, whichever occurs first.|Up to 54 months|||||||
2610007|NCT02059213|Secondary|Time to Biochemical Progression|Biochemical progression-free survival will begin from treatment start until the event of biochemical (PSA) progression or death, whichever occurs first.|Up to 54 months|||||||
2610008|NCT02059213|Secondary|Proportion of Patients Who Achieve Undetectable PSA (<0.2ng/mL)||Up to 54 months|||||||
2610009|NCT02059213|Secondary|Duration of Therapy|Duration of therapy will be reported to describe tolerability within each arm.|Up to 54 months|||||||
2610010|NCT02059213|Secondary|Frequency of Adverse Events|Frequency of adverse event types will be reported for each arm by attribution and grade.|Up to 54 months|||||||
2610011|NCT02059213|Primary|Number of Patients Who Achieve a PSA ≤ 4ng/mL After Seven Months of Protocol Treatment in Each Arm|The primary analysis will be assessment of the proportion of patients who achieve a (Prostate-specific antigen) PSA < 4ng/mL after seven months of protocol treatment in each arm.|28 weeks|72 patients were enrolled to the trial. Seven patients did not have adequate tissue for testing retinoblastoma status. Two patients tested negative for retinoblastoma and one patient was found to have small cell metastasis and not adenocarcinoma. 62 patients were randomized. 60 randomized patients initiated therapy on trial.|||Participants|||Count of Participants
2610012|NCT02059187|Secondary|Percentage of Participants With Hemoglobin A1C <6.5% at Week 24|Percentage of participants with A1C <6.5% (48 mmol/mol) at Week 24.|Week 24|The analysis population included all randomized, treated participants with a Week 24 A1C measurement.|||Percentage of participants|||Number
2610013|NCT02059187|Secondary|Percentage of Participants With Hemoglobin A1C <7% at Week 24|Percentage of participants with A1C <7.0% (53 mmol/mol) at Week 24.|Week 24|The analysis population included all randomized, treated participants with a Week 24 A1C measurement.|||Percentage of participants|||Number
2610014|NCT02059187|Secondary|Change From Baseline in Participant 7-Point Average of Self-Monitored Blood Glucose (SMBG) at Week 24|7-Point Average of SMBG was defined as the mean of blood glucose measurements taken at the following 7 times: before morning meal, after morning meal, before midday meal, after midday meal, before evening meal, after evening meal or at bedtime, and between 2 AM and 4 AM.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
2610015|NCT02059187|Secondary|Change From Baseline in Participant Fasting Plasma Glucose (FPG) at Week 24|Participants fasted (no food or drink except water and non-antihyperglycemic non-study medications as prescribed) for at least 8 hours prior to all study visits.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
2610016|NCT02059187|Secondary|Daily Basal Insulin Dose Per Body Weight (Units/kg) at Week 24|Basal insulin dose per body weight was calculated as total insulin dose (units) per day divided by body weight in kilograms (kg).|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units/kg||95% Confidence Interval|Least Squares Mean
2610018|NCT02059187|Secondary|Percentage of Participants Experiencing an AE Over the 24-week Treatment Period|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an AE.|Up to 24 weeks|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2610019|NCT02059187|Secondary|Percentage of Participants Experiencing an Adverse Event (AE) of Hypoglycemia Up to Week 24|Symptomatic events assessed as likely to be hypoglycemia were to be reported by investigators as adverse events of hypoglycemia; a concurrent glucose measurement was not required. Asymptomatic events with confirmed glucose levels </= 70mg/dL (</= 3.9mmol/L) could also be reported as adverse events at the discretion of the investigator.|Up to 24 weeks|All randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2610020|NCT02059187|Secondary|Change From Baseline in Participant Body Weight at Week 24|Change from baseline in participant body weight at Week 24.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||kilograms||Standard Deviation|Mean
2610021|NCT02059187|Primary|Percentage of Participants With Confirmed Anti-Insulin Antibodies (AIA) up to Week 24|Percentage of participants is a cumulative percentage of participants with any confirmed AIA (including baseline) up to Week 24.|Up to 24 weeks|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Percentage of participants|||Number
2610022|NCT02059187|Primary|Change From Baseline in Participant Hemoglobin A1C Level at Week 24|A1C is measured as a percent. A1C is the key glycemic parameter which correlates with reduction of risk of diabetic complications.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Percent A1C||95% Confidence Interval|Least Squares Mean
2610023|NCT02059174|Secondary|M1 Glargine Metabolite PK: Area Under the Plasma Concentration Versus Time Curve Over the Second 12 Hours After Dosing (AUC12-24)|M1 glargine is the dominant circulating glargine-derived insulin metabolite after subcutaneous injection and it is pharmacologically active. AUC12-24 is a measure of the total amount of drug in the plasma from Hour 12 to Hour 24. Analysis was performed on log scale with results back transformed to original scale.|From 12 to 24 hours postdose|The Per-Protocol population consists of 75 participants, including the 70 with complete data across all 4 treatment periods and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. All available data from 5 of the participants who discontinued the study were included in the analyses.|||pg∙hr/mL||95% Confidence Interval|Geometric Mean
2610024|NCT02059174|Secondary|M1 Glargine Metabolite PK: Area Under the Plasma Concentration Versus Time Curve Over the First 12 Hours After Dosing (AUC0-12)|M1 glargine is the dominant circulating glargine-derived insulin metabolite after subcutaneous injection and it is pharmacologically active. AUC0-12 is a measure of the total amount of drug in the plasma from the dose to Hour 12. Analysis was performed on log scale with results back transformed to original scale.|Up to 12 hours postdose|The Per-Protocol population consists of 75 participants, including the 70 with complete data across all 4 treatment periods and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. All available data from 5 of the participants who discontinued the study were included in the analyses.|||pg∙hr/mL||95% Confidence Interval|Geometric Mean
2610025|NCT02059174|Primary|M1 Glargine Metabolite PK: Maximum Plasma Concentration (Cmax)|M1 glargine is the dominant circulating glargine-derived insulin metabolite after subcutaneous injection and it is pharmacologically active. Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Analysis was performed on log scale with results back transformed to original scale.|Up to 24 hours postdose|The Per-Protocol population consists of 75 participants, including the 70 with complete data across all 4 treatment periods and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. All available data from 5 of the participants who discontinued the study were included in the analyses.|||pg/mL||95% Confidence Interval|Geometric Mean
2610026|NCT02059174|Primary|M1 Glargine Metabolite Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC0-24)|M1 glargine is the dominant circulating glargine-derived insulin metabolite after subcutaneous injection and it is pharmacologically active. AUC0-24 is a measure of the total amount of drug in the plasma from the dose to Hour 24. Analysis was performed on log scale with results back transformed to the original scale|Up to 24 hours postdose|The Per-Protocol population consists of 75 participants, including the 70 with complete data across all 4 treatment periods and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. All available data from 5 of the participants who discontinued the study were included in the analyses.|||pg∙hr/mL||95% Confidence Interval|Geometric Mean
2610027|NCT02059174|Primary|PD: Maximum Glucose Infusion Rate (GIRmax)|Maximum glucose infusion rate (GIR[max]) based on smoothed data for participants who received either MK-1293 or EU-Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure.|Up to 30 hours postdose|The Per-Protocol population included 70 participants with complete data and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. Data from 5 discontinued participants were included in the analyses; data from 1 participant was not (incomplete clamp data, only out to 18.5 hours).|||mg/kg/min||95% Confidence Interval|Mean
2610028|NCT02059174|Primary|PD: Area Under the Glucose Infusion Rate Versus Time Curve Over the Second 12 Hours After Dosing (GIR-AUC12-24hr)|The area under the glucose infusion rate curve from hours 12 to 24 after injection (AUC[GIR{12-24}]) for participants who received either MK-1293 or Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure.|From 12 to 24 hours postdose|The Per-Protocol population included 70 participants with complete data and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. Data from 5 discontinued participants were included in the analyses; data from 1 participant was not (incomplete clamp data, only out to 18.5 hours).|||mg/kg||95% Confidence Interval|Mean
2610029|NCT02059174|Primary|PD: Area Under the Glucose Infusion Rate Versus Time Curve Over the First 12 Hours After Dosing (GIR-AUC0-12hr)|The area under the glucose infusion rate curve from hours 0 to 12 after injection (AUC[GIR{0-12}]) for participants who received either MK-1293 or EU-Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure.|Up to 12 hours postdose|The Per-Protocol population consists of 75 participants, including the 70 with complete data across all 4 treatment periods and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. All available data from 5 of the participants who discontinued the study were included in the analyses.|||mg/kg||95% Confidence Interval|Mean
2610030|NCT02059174|Primary|PD: Area Under the Glucose Infusion Rate Versus Time Curve Over 24 Hours After Dosing (GIR-AUC0-24hr)|The area under the glucose infusion rate curve from hours 0 to 24 after injection (AUC[GIR{0-24}]) for participants who received either MK-1293 or EU-Lantus™ administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design was measured from blood samples obtained during a euglycemic clamp procedure.|Up to 24 hours postdose|The Per-Protocol population included 70 participants with complete data and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. Data from 5 discontinued participants were included in the analyses; data from 1 participant was not (incomplete clamp data, only out to 18.5 hours).|||mg/kg||95% Confidence Interval|Mean
2610031|NCT02059174|Primary|Comparison of MK-1293 and EU-Approved Lantus Duration of Pharmacodynamic Action During a 30-Hour Euglycemic Clamp Study|Duration of Action (DOA) is defined as the length of time from dosing to End of Action. End of Action is defined as the time point at which plasma glucose has been above 150 mg/dL for 30 minutes and no glucose has been infused for 30 minutes. Median and max below are reported for the length of clamp duration (i.e. 30 hours).|Up to 30 hours postdose|The Per-Protocol population consists of 75 participants, including the 70 with complete data across all 4 treatment periods and 5 participants with partial data. One participant was not included in the PP population due to a medical issue. All available data from 5 of the participants who discontinued the study were included in the analyses.|||Hours||Full Range|Median
2610032|NCT02059161|Secondary|Bolus Insulin Dose Per kg of Body Weight at Week 24|Bolus Insulin Dose per kg of Body Weight at Week 24.|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units/kg||95% Confidence Interval|Least Squares Mean
2610033|NCT02059161|Secondary|Bolus Insulin Dose at Week 24|Bolus Insulin Dose at Week 24.|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units||95% Confidence Interval|Least Squares Mean
2610034|NCT02059161|Secondary|Basal Insulin Dose Per kg of Body Weight at Week 24|Basal Insulin Dose per kg of Body Weight at Week 24.|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units/kg||95% Confidence Interval|Least Squares Mean
2610035|NCT02059161|Secondary|Basal Insulin Dose at Week 24|Basal Insulin Dose at Week 24.|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units||95% Confidence Interval|Least Squares Mean
2610036|NCT02059161|Secondary|Bolus Insulin Dose Per kg of Body Weight at Week 52|Bolus Insulin Dose per kg of Body Weight at Week 52.|Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units/kg||95% Confidence Interval|Least Squares Mean
2610037|NCT02059161|Secondary|Bolus Insulin Dose at Week 52|Bolus Insulin Dose at Week 52.|Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units||95% Confidence Interval|Least Squares Mean
2610038|NCT02059161|Secondary|Basal Insulin Dose Per kg of Body Weight at Week 52|Basal Insulin Dose per kg of Body Weight at Week 52.|Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units/kg||95% Confidence Interval|Least Squares Mean
2610039|NCT02059161|Secondary|Basal Insulin Dose at Week 52|Basal Insulin Dose at Week 52.|Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Units||95% Confidence Interval|Least Squares Mean
2610040|NCT02059161|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 52 Weeks of Treatment.|Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 52 weeks of treatment.|52 weeks|The analysis population included all randomized, treated participants with a Week 52 A1C measurement.|||Percentage of participants|||Number
2610041|NCT02059161|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 24 Weeks of Treatment.|Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 24 weeks of treatment.|24 weeks|The analysis population included all randomized, treated participants with a Week 24 A1C measurement.|||Percentage of participants|||Number
2610042|NCT02059161|Secondary|Change From Baseline in 7-point SMBG at Week 52|The 7-point SMBG profile consisted of the following measurements by glucose meter: morning pre-meal (fasting), 2 hours after morning meal, midday pre-meal, 2 hours after midday meal, evening pre meal, pre-bedtime (pre-dose and at least 2 hours after evening meal), between 2:00 AM and 4:00 AM in the morning.|Baseline and Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
2610043|NCT02059161|Secondary|Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) at Week 24|The 7-point SMBG profile consisted of the following measurements by glucose meter: morning pre-meal (fasting), 2 hours after morning meal, midday pre-meal, 2 hours after midday meal, evening pre meal, pre-bedtime (pre-dose and at least 2 hours after evening meal), between 2:00 AM and 4:00 AM in the morning.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
2610075|NCT02059057|Secondary|Mean Change in Residual Volume (RV)|Residual volume is the amount of air that remains in a person's lungs after fully exhaling. A decrease in residual volume indicates improvement in patients with higher residual volume measures.|Change in Baseline to 12 months|Only patients who had both baseline and 12 month data were analyzed. Missing values were not imputed.|||Liters||Standard Deviation|Mean
2610044|NCT02059161|Secondary|Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 52|Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Thought Week 52. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INAb) development up through 52 weeks of treatment.|Up to Week 52|The analysis population included all randomized, treated participants who were INAb negative at baseline and who had data for INAb at or before Week 52.|||Percentage of participants|||Number
2610045|NCT02059161|Secondary|Change From Baseline in FPG at Week 52|Blood glucose was measured on a fasting basis (collected after a 10-hour fast). This change from baseline reflects the FPG level at Week 52 minus the FPG level at Week 0.|Baseline and Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
2610046|NCT02059161|Secondary|Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 52|Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).|Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Insulin units/kg.||95% Confidence Interval|Least Squares Mean
2610047|NCT02059161|Secondary|Total Insulin Dose at Week 52|Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).|Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Insulin units||95% Confidence Interval|Least Squares Mean
2610048|NCT02059161|Secondary|Change From Baseline in AIA Titer After 52 Weeks of Treatment|This immunogenicity analysis assessed the effect of treatment with MK-1293 compared with Lantus on anti-insulin antibody development after 52 weeks of treatment. This change from baseline reflects the AIA titers at Week 52 minus the AIA titers at Week 0.|Baseline and Week 52|The analysis population included all randomized, treated participants who had AIA data at baseline and Week 52.|||AIA Titers||Standard Deviation|Mean
2610049|NCT02059161|Secondary|Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 52|Percentage of participants who became positive to AIA at or before Week 52, among participants who were AIA negative at baseline.|Up to Week 52|The analysis population included all randomized, treated participants who had data for AIA at baseline and Week 52.|||Percentage of participants|||Number
2610050|NCT02059161|Secondary|Percentage of Participants With Confirmed Positive AIA Up Through Week 52|Percentage of participants with confirmed positive AIA at any time up through Week 52 including baseline.|Up to Week 52 including baseline|The analysis population included all randomized, treated participants who had data for AIA at or before Week 52.|||Percentage of participants|||Number
2610051|NCT02059161|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Blood glucose was measured on a fasting basis (collected after a 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
2610052|NCT02059161|Secondary|Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 24|Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Insulin units/kg.||95% Confidence Interval|Least Squares Mean
2610053|NCT02059161|Secondary|Total Insulin Dose at Week 24|Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication).|Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Insulin units||95% Confidence Interval|Least Squares Mean
2610054|NCT02059161|Secondary|Change From Baseline in A1C at Week 52|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 52 A1C minus the Week 0 A1C.|Baseline and Week 52|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Percent||95% Confidence Interval|Least Squares Mean
2610055|NCT02059161|Primary|Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24|Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INab) development up through 24 weeks of treatment.|Up to Week 24|The analysis population included all randomized, treated participants who were INAb negative at baseline and who had data for INAb at or before Week 24.|||Percentage of participants|||Number
2610056|NCT02059161|Primary|Change From Baseline in AIA Titer After 24 Weeks of Treatment|This immunogenicity analysis will assess the effect of treatment with MK-1293 compared with Lantus on anti-insulin antibody development after 24 weeks of treatment. This change from baseline reflects the Week 24 AIA titer minus the Week 0 AIA titer.|Baseline and Week 24|The analysis population included all randomized, treated participants who had AIA data at baseline and Week 24.|||AIA Titers||Standard Deviation|Mean
2610057|NCT02059161|Primary|Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 24|Percentage of participants who became positive to AIA at or before Week 24, among participants who were AIA negative at baseline.|Up to Week 24|The analysis population included all randomized, treated participants who were AIA negative at baseline and had data for AIA at or before Week 24.|||Percentage of participants|||Number
2610058|NCT02059161|Primary|Percentage of Participants With Any Confirmed Positive Anti-insulin Antibody (AIA) at Any Time Up Through Week 24|Percentage of participants with confirmed positive AIA at any time up through Week 24 including baseline.|Up to Week 24|The analysis population included all randomized, treated participants who had data for AIA at or before Week 24.|||Percentage of participants|||Number
2610059|NCT02059161|Primary|Primary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 24 A1C minus the Week 0 A1C.|Baseline and Week 24|The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint.|||Percent||95% Confidence Interval|Least Squares Mean
2610060|NCT02059148|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC 0-t Last) of LSN3106726 (M20)|Area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of LSN3106726 (M20), an active metabolite of LY2835219.|Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period|All randomized participants receiving at least one dose of the investigational product.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2610061|NCT02059148|Secondary|Pharmacokinetics: Tmax of LY2835219 in Standard Meal Arm||Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period|All randomized participants receiving at least one dose of the investigational product.|||hour (h)||Full Range|Median
2610062|NCT02059148|Secondary|Pharmacokinetics: AUC(0-tlast) of LY2835219 in Standard Meal Arm||Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period|All randomized participants receiving at least one dose of the investigational product.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2610063|NCT02059148|Secondary|Pharmacokinetics: Cmax of LY2835219 in Standard Meal Arm||Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period|All randomized participants receiving at least one dose of the investigational product.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2610064|NCT02059148|Primary|Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of LY2835219 Fasted vs. High-Fat Arms||Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period|All randomized participants receiving at least one dose of the investigational product.|||hour (h)||Full Range|Median
2610065|NCT02059148|Primary|Pharmacokinetics: Area Under the Concentration Curve (0-t Last) [AUC(0-t Last)] of LY2835219 Fasted vs. High-Fat Arms||Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period|All randomized participants receiving at least one dose of the investigational product.|||nanogram*hour/mL (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2610066|NCT02059148|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2835219 Fasted vs. High-Fat Arms||Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period|All randomized participants receiving at least one dose of the investigational product.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2610067|NCT02059135|Other Pre-specified|Number of Participants Experiencing Individual Maternal, Perinatal and Neonatal Outcomes and Number of Participants Who Avoided All Neonatal Morbidity and Mortality|Maternal and fetal/neonatal outcomes of specific interest were defined in the protocol. Maternal subjects were assessed through 4-6 weeks post delivery to determine if outcomes had occurred. Neonatal outcomes were assessed from birth until 36 weeks post menstrual age, or through the 4-6 week post delivery visit (if 36 weeks PMA occurs <28 days following delivery). A second fetal/neonatal composite outcome was the avoidance of fetal/neonatal mortality and neonatal morbidity [BPD, IVH grade ≥ 3, cystic PVL, ROP stage ≥ 3, late sepsis, and NEC (Bell's stage ≥ 2)].|Maternal-till 4-6 weeks post delivery.Neonatal -birth until the later of 36 weeks PMA and the 36 weeks PMA visit, or through the 4-6 weeks post-delivery visit (if both 36 weeks PMA and the 36 weeks PMA visit occurred less than 28 days following delivery).|ITT|||participants|||Number
2610068|NCT02059135|Secondary|Composite Measure of Specific Fetal and Neonatal Outcomes Based on Protocol Defined 5-point Scale (Scores of 0 to 4)|"Composite score was calculated based on the following fetal and neonatal events: bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), cystic periventricular leucomalacia (PVL), retinopathy of prematurity (ROP), late Sepsis, necrotizing enterocolitis (NEC) and mortality (fetal and neonatal). The endpoint is measured on a 5 point scale where 0 represents no outcomes experienced and no mortality, and 4 represents death, as shown below. Should the same outcome occur more than once, it will only be counted once.~Score Outcome 0 No events, no mortality~One event, no mortality~Two events, no mortality~Three or more events, no mortality~Death"|Neonatal outcomes were assessed from birth until the later of 36 weeks (wks) Post Menstrual Age (PMA) and the 36 wks PMA visit, or through the 4-6 weeks post-delivery visit (if both 36 wks PMA and the 36 wks PMA visit occurred < 28 days post delivery)|ITT|||scores on a scale of 0 to 4||Standard Deviation|Mean
2610069|NCT02059135|Primary|Increase in Gestational Age in Days|Increase in gestational age is defined as the gestational age at delivery minus the gestational age at randomization.|Subjects will continue on study drug until maternal and/or fetal indications for delivery necessitate cessation of expectant management or until 34 0/7 weeks of gestation.|ITT|||days||Full Range|Median
2610070|NCT02059070|Secondary|Post-operative Oxycodone Use (mg)|The total amount of oxycodone medication (mg) that the patient consumed in the 24 hours post surgery.|The 24 hour period following surgery||||mg||Standard Deviation|Mean
2610071|NCT02059070|Other Pre-specified|Highest Patient Pain Level|The Visual analog pain scale ranges from 0 to 10, with higher scores indicating higher pain|Within 36 hours of surgery||||VAS units on a scale||Standard Deviation|Mean
2610072|NCT02059070|Secondary|Ultrasonographic Evaluation of Diaphragmatic Excursion- Operative Side Sigh Test|For ultrasonographic evaluation if caudad movement of the hemidiaphragm was observed, the distance was measured recorded and assigned a positive (+) value. If paradoxical cephalad movement of the diaphragm was observed, the distance was given a negative value (-). Each measurement was performed 3 times and the best value was recorded.|Within 36hrs following surgery||||percentage of baseline change||Standard Deviation|Mean
2610073|NCT02059070|Primary|Forced Expiratory Volume at 1 Second (% Change From Baseline)||Within the first 4 days following surgery||||percentage of change from baseline||Standard Deviation|Mean
2610074|NCT02059057|Secondary|Mean Change in St. Georges Respiratory Questionnaire (SGRQ)|"Measure Description: The SGRQ is designed to measure health impairment in patients with asthma and COPD.~It consists of 50 items and has two parts: Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale)~Scores range from 0 to 100, with higher scores indicating more limitations.~A negative change in score indicates improvement, with a mean change of 4 points being the minimal important difference."|Change in Baseline to 12 months|Only patients who had both baseline and 12 month data were analyzed. Missing values were not imputed.|||units on a scale||Standard Deviation|Mean
2610104|NCT02058940|Secondary|Median Insulin Use|Calculated from number of insulin units administered over 48 hours starting at infusion initiation|Over 48 hours from infusion initiation||||units/kg||Inter-Quartile Range|Median
2610076|NCT02059057|Secondary|Mean Percent Change in Forced Expiratory Volume in One Second (FEV1)|The forced expiratory volume in one second (FEV1) measurement shows the amount of air a person can forcefully exhale in one second. Typically, lower FEV1 scores show more severe stages of lung disease. A positive change in FEV1 indicates improvement in lung function.|Change in Baseline to 12 months|Only patients who had both baseline and 12 month data were analyzed. Missing values were not imputed.|||% change||Standard Deviation|Mean
2610077|NCT02059057|Primary|Mean Change in Six Minute Walk Test (6MWT)|Mean absolute change from baseline to12 months. The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.|Change in Baseline to 12 months|Only patients who had both baseline and 12 month data were analyzed. Missing values were not imputed.|||meters||Standard Deviation|Mean
2610078|NCT02059005|Secondary|Number of Hospitalizations and Use of Emergency Services|Days of hospitalization and days of use of acute emergency services after Baseline. Participants self-reported their service utilization for the 6 months prior to the baseline assessment. During follow-up assessments, participants self-reported their service utilization since the last assessment date.|0, 3, 6, months|The number analyzed in row differs from overall because the mixed-effects model analyses included participants who completed baseline and at least one follow-up. As a result, the number analyzed at each follow-up differed.|||Days of ER or Hospital Utilization||Standard Deviation|Mean
2610079|NCT02059005|Secondary|Change in Treatment Session Attendance From Baseline|Treatment sessions attended for alcohol or drug use issues over time. Participants self-reported attendance for the 6 months prior to the baseline assessment. During follow-up assessments, participants self-reported attendance since the last assessment date.|0, 3, 6, months|The number analyzed in row differs from overall because the mixed-effects model analyses included participants who completed baseline and at least one follow-up. As a result, the number analyzed at each follow-up differed.|||Days of attending treatment sessions||Standard Deviation|Mean
2610080|NCT02059005|Primary|Change in Substance Use Rates From Baseline|Urinalysis confirmed self-reported days of use for any substance, including alcohol, cocaine, marijuana, opiates, sedatives, and hallucinogens over time. Participants reported substance use for the 90 days prior to the assessment date.|0, 3, 6 months|The number analyzed in row differs from overall because the mixed-effects model analyses included participants who completed baseline and at least one follow-up. As a result, the number analyzed at each follow-up differed.|||Days of Substance Use||Standard Deviation|Mean
2610081|NCT02058992|Secondary|Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4|"PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. 7 items on scale include sleep onset, sleep time, sleep quality, morning awakening, morning tiredness, daytime somnolence, and daytime physical condition/function. Participants provide their response on a PGI questionnaire. The results of survey using the PGI questionnaire was scored, summarized and assessed. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported for sleep onset,time, quality; morning awakening, tiredness and daytime sleepiness, physical condition."|Week 4|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||percentage of participants|||Number
2610082|NCT02058992|Secondary|Sleep Status: Number of Awakenings|Sleep status of participants was assessed and summarized by calculating the number of times participants had awaken from the time of start of the investigation.|Baseline and Week 4|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||number of awakenings||Standard Deviation|Mean
2610083|NCT02058992|Secondary|Sleep Status: Total Sleep Time|Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode.|Baseline and Week 4|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||hours||Standard Deviation|Mean
2610084|NCT02058992|Secondary|Sleep Status: Sleep Onset Latency|Sleep status was determined by measuring the sleep onset latency, defined as the length of time taken from lying down for the night until sleep onset.|Baseline and Week 4|The efficacy assessment population was defined as participants whose efficacy data at baseline and at least 1 post-baseline time points was available.|||minutes||Standard Deviation|Mean
2610085|NCT02058992|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 6 weeks|SAS was defined as participants who were enrolled and completed the study.|||participants|||Number
2610086|NCT02058992|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 6 weeks|Safety analysis set was defined as participants who were enrolled and completed the study.|||participants|||Number
2610100|NCT02058940|Secondary|Percentage of Patients Experiencing Metabolic Crisis|Metabolic crisis is defined as cerebral microdialysate glucose concentration <0.7 mmol/L in combination with lactate pyruvate ratio >40. Calculated from hourly microdialysis samples starting at infusion initiation over 48 hours|Over 48 hours from infusion initiation|No patients received invasive intracranial multimodal monitoring as a part of their standard of care, as such, these endpoints were not collected.||||||
2610101|NCT02058940|Secondary|Percentage of Patients With >1 Episode of Hypoglycemia (<80 mg/dL)|Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours|Over 48 hours from infusion initiation||||percentage of patients|||Number
2610087|NCT02058966|Secondary|Cognitive Function|Two computer tests were administered to measure how each medication intervention effects cognitive functioning. The tests administered included the Rapid Visual Information Processing Task (RVIPT), a 6 minute test of sustained attention in which participants are requested to detect target sequences of digits and the Digit Symbol Substitution Task (DSST), a 2 minute test of psychomotor speed and sustained attention consisting of digit-symbol pairs followed by a list of digits where the subject identifies the symbol that corresponds to each digit as fast as possible. The number of correct responses within the allowed time is measured. Higher scores on both tasks indicate better performance.|Measurements acquired before drug ingestion (baseline) then hourly for 4 hours. The peak interaction effect of entacapone and methamphetamine occurs 1 hour after ingestion, therefore the reported values are from this timepoint.|The analysis population includes only the 12 subjects that completed each arm, or intervention, of the study.|||number of correct answers||Standard Deviation|Mean
2610088|NCT02058966|Primary|Effect of Entacapone on Methamphetamine-induced Stimulation|"The Global Rating of Stimulation is a 1-item question I feel light-headed, restless, or speeded-up in which the participant is asked to circle one answer on a scale from 0-4, 0 is 'normal', 1 is 'slightly', 2 is 'moderately', 3 is 'very much', and 4 is 'extremely'. Whichever number they circled is their reported score. A higher score is indicative of a greater stimulating effect."|Measurements acquired before drug ingestion (baseline) then hourly for 4 hours. The peak interaction effect of entacapone and methamphetamine occurs 1 hour after ingestion, therefore the reported values are from this timepoint.|The analysis population includes only the 12 subjects that completed each arm, or intervention, of the study.|||units on a scale||Standard Deviation|Mean
2610089|NCT02058966|Primary|Effect of Entacapone on Subjective Effects of Methamphetamine|The subjective effects of the study drug were evaluated with the Addiction Research Center Inventory (ARCI-49), a 49 item questionnaire consisting of true/false items. True items receive a score of 1 if answer is 'True', false items receive a score of 1 if answer is 'False'. No points are given when answer is opposite to scoring direction. There are 5 subscales: Morphine Benzedrine group scale to measure euphoria (range: 0-16 with higher numbers indicating more euphoria), A Lysergic Acid Diethylamide group scale to estimate dysphoria and agitation (range: 0-14 with higher scores indicating more dysphoria), a Pentobarbital Chlorpromazine Alcohol group scale to measure sedation (range: 0-15 with higher scores indicating more sedation), and a Benzedrine group scale and an Amphetamine Scale to assess stimulant effects (range: 0-13 and 0-11, respectively, with higher scores indicating higher stimulant effects) .|Measurements acquired before drug ingestion (baseline) then hourly for 4 hours. The peak interaction effect of entacapone and methamphetamine occurs 1 hour after ingestion, therefore the reported values are from this timepoint.|The analysis population includes only the 12 subjects that completed each arm, or intervention, of the study.|||units on a scale||Standard Deviation|Mean
2610090|NCT02058966|Primary|Effect of Entacapone on Methamphetamine-induced Mood|Profile of Mood States is a 65 item questionnaire using a Likert rating scale to assess transient, distinct moods. The questionnaire contains 65 words/statements that describe feelings people have. The test requires you to indicate for each word or statement how you have been feeling in the past week including today. A Total Mood Disturbance score is calculated by adding scores for Tension, Depression, Anger, Fatigue and Confusion and then subtracting the Vigour score. The Total Mood Disturbance scale ranges from -32 to 200 with lower scores indicative of people with more stable mood profiles.|Measurements acquired before drug ingestion (baseline) then hourly for 4 hours. The peak interaction effect of entacapone and methamphetamine occurs 1 hour after ingestion, therefore the reported values are from this timepoint.|The analysis population includes only the 12 subjects that completed each intervention of the study.|||units on a scale||Standard Deviation|Mean
2610091|NCT02058940|Secondary|Median Hospital Length of Stay|Defined as the number of days admitted to the hospital|From enrollment to 30 days post study drug discontinuation||||days||Inter-Quartile Range|Median
2610092|NCT02058940|Secondary|Median Intensive Care Unit Length of Stay|Defined as the number of days admitted to the Intensive Care Unit|From enrollment to 30 days post study drug discontinuation||||days||Inter-Quartile Range|Median
2610093|NCT02058940|Secondary|Exenatide Area Under the Concentration-time Curve After Discontinuation of Infusion||24 hours|The institutional review board requested the study team limit exenatide concentration sampling to during the infusion. Samples were not collected after discontinuation of study drug. As such, this pharmacokinetic parameter is not reported.||||||
2610094|NCT02058940|Secondary|Exenatide Elimination Rate Constant After Discontinuation of Infusion||24 hours|The institutional review board requested the study team limit exenatide concentration sampling to during the infusion. Samples were not collected after discontinuation of study drug. As such, this pharmacokinetic parameter is not reported.||||||
2610095|NCT02058940|Secondary|Correlation of Exenatide Concentrations With Creatinine Clearance|Spearman's correlation coefficient calculated from exenatide concentrations and urine creatinine measurements collected for all patients during the study period. A correlation coefficient is a numerical measure of some type of correlation, meaning a statistical relationship between two variables. Spearman's correlation coefficient assumes values in the range from −1 to +1, where +1 indicates the strongest possible agreement and −1 the strongest possible disagreement.|Over 48 hours from infusion initiation||||correlation coefficient|||Number
2610096|NCT02058940|Secondary|Percentage of Patients With >1 Episode of Hypotensive Episode (SBP<100 mmHg)|Calculated from blood pressure measurements starting at infusion initiation over 48 hours|Over 48 hours from infusion initiation||||percentage of patients|||Number
2610097|NCT02058940|Secondary|Percentage of Hypotensive Episodes (SBP<100 mmHg)|Defined as the number of hypotensive episodes (SBP<100 mmHg)for all patients/total number of blood pressure measurements collected for all patients.|Over 48 hours from infusion initiation||||percentage of measurements|||Number
2610098|NCT02058940|Secondary|Median Daily Cerebral Perfusion Pressure|Calculated from hourly measurements starting at infusion initiation over 48 hours|Over 48 hours from infusion initiation|No patients with an admitting diagnosis of Subarachnoid Hemorrhage received ICP or CPP monitoring as part of standard of care and therefore data is not reported.||||||
2610099|NCT02058940|Secondary|Median Daily Intracranial Pressure|Calculated from hourly measurements starting at infusion initiation over 48 hours|Over 48 hours from infusion initiation|No patients with an admitting diagnosis of Subarachnoid Hemorrhage received ICP or CPP monitoring as part of standard of care and therefore data is not reported.||||||
2610107|NCT02058940|Secondary|Percentage of Glucose Measurements Within Goal Range|Percentage of glucose measurements within goal range is calculated as the number of glucose measurements within goal range (110-180 mg/dL) for all patients/total number of glucose measurements collected for all patients.|Over 48 hours from infusion initiation||||percentage of measurements|||Number
2610108|NCT02058940|Secondary|Median Glucose Concentration During Exenatide Infusion|Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours|Over 48 hours from infusion initiation||||mg/dL||Inter-Quartile Range|Median
2610109|NCT02058940|Primary|Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria|Feasibility is defined as the percentage of patients 1) experiencing severe hypoglycemia (<40 mg/dL); 2) achieving glucose measurements within goal (110-180 mg/dL); and 3) experiencing nausea requiring discontinuation of exenatide therapy. The pre-specified criteria for determining feasibility includes the following: 1) at least 75% of patients achieving glucose measurements within goal (110-180 mg/dL) and 2) no more than 25% of patients experiencing severe hypoglycemia (<40 mg/dL) or nausea requiring exenatide discontinuation.|Over 48 hours from infusion initiation||||percentage of patients|||Number
2610110|NCT02058849|Other Pre-specified|Total Body Mass|Kilograms of body mass|Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).||||kilograms||Standard Deviation|Mean
2610111|NCT02058849|Other Pre-specified|Fat Free Mass|Kilograms of fat free mass|Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).|Midpoint data were not collected from the placebo group for this outcome.|||kilograms||Standard Deviation|Mean
2610112|NCT02058849|Other Pre-specified|Bone Mineral Density|Bone mineral density (grams per centimeter squared)|Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).|Midpoint data were not collected from the placebo group for this outcome.|||grams per centimeter squared||Standard Deviation|Mean
2610113|NCT02058849|Other Pre-specified|Bone Mineral Content|Bone mineral content (grams).|Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).||||grams||Standard Deviation|Mean
2610114|NCT02058849|Other Pre-specified|Body Fat|Grams of body fat|Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).||||grams||Standard Deviation|Mean
2610115|NCT02058849|Other Pre-specified|Handgrip Strength at 30 Seconds|Handgrip strength (kg) at 30 seconds measured using a handgrip dynamometer|Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).||||kg||Standard Deviation|Mean
2610116|NCT02058849|Other Pre-specified|Handgrip Strength|Peak force (kg) measured using a handgrip dynamometer|Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).||||kg||Standard Deviation|Mean
2610117|NCT02058849|Secondary|Muscle Strength|Peak force (Nm) from one-legged maximum voluntary contraction (MVC) using the Biodex isokinetic machine.|Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).|Midpoint data were not collected from the placebo group for this outcome.|||Nm||Standard Deviation|Mean
2610118|NCT02058849|Secondary|Body Composition (Lean Body Mass)|Grams of lean body mass|Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).||||grams||Standard Deviation|Mean
2610119|NCT02058849|Primary|Endurance|Biodex endurance peak torque (Nm)|Baseline (1-2 weeks pre-IMRT), Midpoint (7-8 weeks following IMRT initiation), Endpoint (4-6 weeks following Midpoint).||||Nm||Standard Deviation|Mean
2610120|NCT02058849|Primary|Adherence to Treatment|Number of patients completing radiotherapy and three cycles of chemotherapy with no delay|Up to 6 weeks||||Participants|||Count of Participants
2610121|NCT02058836|Primary|Units of Analgesics Used for Testicular Pain|Change from Baseline in Units of Analgesics Used for Testicular Pain|6 months||||units of analgesics||Standard Deviation|Mean
2610122|NCT02058836|Primary|Units of Analgesics Used for Testicular Pain|Change from Baseline in Units of Analgesics Used for Testicular Pain|3 months||||units of analgesics||Standard Deviation|Mean
2610123|NCT02058836|Primary|Units of Analgesics Used for Testicular Pain|Change from Baseline in Units of Analgesics Used for Testicular Pain|1 month||||units of analgesics||Standard Deviation|Mean
2610124|NCT02058836|Primary|Units of Analgesics Used for Testicular Pain|Change from Baseline in Units of Analgesics Used for Testicular Pain|1 week||||units of analgesics||Standard Deviation|Mean
2610125|NCT02058836|Primary|Quality of Life Questionnaire Score|Quality of Life Questionnaire Score (QOL). To assess the QOL, a short form-36 (SF-36) was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight items, which are the weighted sums of the questions in their section. The eight items are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores. Scale scores represent the average for all items in the scale that the respondent answered. Higher scores denotes better outcomes.|6 months||||units on a scale||Standard Deviation|Mean
2610126|NCT02058836|Primary|Quality of Life Questionnaire Score|Quality of Life Questionnaire Score (QOL). To assess the QOL, a short form-36 (SF-36) was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight items, which are the weighted sums of the questions in their section. The eight items are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores. Scale scores represent the average for all items in the scale that the respondent answered. Higher scores denotes better outcomes.|3 months||||units on a scale||Standard Deviation|Mean
2610331|NCT02057549|Secondary|Nausea Score as Measured by a Visual Analogue Scale (VAS)|The Visual Analogue Scale (VAS) ranges from 1-5, with 1 being minimal nausea and 5 being severe nausea.|before study medication given||||units on a scale||Standard Deviation|Mean
2610127|NCT02058836|Primary|Quality of Life Questionnaire Score|Quality of Life Questionnaire Score. To assess the QOL, a SF-36 was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The score range is 0-100 and higher scores denotes better outcomes.|1 month||||units on a scale||Standard Deviation|Mean
2610128|NCT02058836|Primary|Quality of Life Questionnaire Score|Quality of Life Questionnaire Score (QOL). To assess the QOL, a short form-36 (SF-36) was used. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. The SF-36 consists of eight items, which are the weighted sums of the questions in their section. The eight items are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores. Scale scores represent the average for all items in the scale that the respondent answered. Higher scores denotes better outcomes.|1 week||||units on a scale||Standard Deviation|Mean
2610129|NCT02058836|Primary|Visual Analog Scale for Pain Score|Visual Analog Scale for Pain score. It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes.|6 months||||units on a scale||Standard Deviation|Mean
2610130|NCT02058836|Primary|Visual Analog Scale for Pain Score|Visual Analog Scale for Pain Score. It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes.|3 months||||units on a scale||Standard Deviation|Mean
2610131|NCT02058836|Primary|Visual Analog Scale for Pain Score|Visual Analog Scale for Pain Score. It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes.|1 month||||units on a scale||Standard Deviation|Mean
2610132|NCT02058836|Primary|Visual Analog Scale for Pain Score|Visual Analog Scale for Pain Score (VAS). It measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms such as pain. VAS is a straight horizontal line of fixed length, usually 100 mm. The patient marks on the line the point that they feel represents their perception of their current state.The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks. The score range is from 0-100. Lower scores denotes better outcomes.|Baseline and 1 Week Post Injection||||units on a scale||Standard Deviation|Mean
2610133|NCT02058628|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) Related to Study Medication|Adverse events are defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious adverse events are defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect and medically significant. TEAEs and TESAEs were reported up to 12 weeks.|Up to Week 12|ITT population.|||Participants|||Count of Participants
2610134|NCT02058628|Secondary|Absolute Change From Baseline in Total Score as Per Children's Dermatology Life Quality Index (CDLQI) at Week 2,4,8 and 12|This outcome measure was a measure of QOL. The CDLQI was used to assess the quality of life at each visit. Participants completed the questionnaire to evaluate how their acne has affected their life. The DLQI is a 10 item questionnaire, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question was scored out of 0-3, as follows: 0- Not at all, 1- A little, 2- A lot, 3- very much, indicating 0 as the least and 3 as the best quality Index. The sub-scale scores of 10 questions were combined and a composite score was presented. The total score ranged from 0 to 30, 0 indicated the least and highest score indicated the best quality Index. The CDLQI was for participants with 12 to 16 years of age. Baseline was defined at Visit 1 (Day 1). Change from Baseline is the value at indicated time point minus the Baseline value.|Baseline (Day 1) up to Weeks 2, 4, 8, 12|MITT population. Only those participants available at the indicated time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2610146|NCT02058589|Secondary|Number of Subjects With Changes in Allograft Function|Allograft function was indicated by the increase in levels of serum creatinine (≥ 1.20, ≥ 1.50, ≥ 1.75 or ≥ 2 fold increase). The number of subjects with declining allograft function, as determined by serum creatinine measurements post-vaccination (from 30 days post-last vaccination up to study end) compared to pre-vaccination were presented.|From 1 month post last vaccination (Month 2) until study end (Month 13)|The analysis was performed on subjects with pre and post vaccination serum creatinine data available from Month 2 to Month 13, from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
2610135|NCT02058628|Secondary|Absolute Change From Baseline in Total Score as Per Dermatology Life Quality Index (DLQI) at Week 2,4,8 and 12|This outcome measure was a measure of quality of life (QOL). The DLQI was used to assess the quality of life at each visit. Participants completed the questionnaire to evaluate how their acne has affected their life. The DLQI is a 10 item questionnaire, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question was scored out of 0-3, as follows: 0- Not at all, 1- A little, 2- A lot, 3- very much, indicating 0 as the least and 3 as the best quality Index. The sub-scale scores of 10 questions were combined and a composite score was presented. The total score ranged from 0 to 30, 0 indicated the least and highest score indicated the best quality Index. The DLQI was for participants with 17 to 45 years of age. Baseline was defined at Visit 1 (Day 1). Change from Baseline is the value at indicated time point minus the Baseline value.|Baseline (Day 1) up to Weeks 2, 4, 8, 12|MITT population. Only those participants available at the indicated time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2610136|NCT02058628|Secondary|Number of Treatment Adherent Participants at Week 12|The general assessment of 'overall satisfaction' with study therapy was assessed at week 12 on a 0-4 point rating scale (0-Very satisfied, 1- Satisfied, 2- Neutral, 3- Unsatisfied and 4- Very unsatisfied).|Week 12|MITT population.|||Participants|||Count of Participants
2610137|NCT02058628|Secondary|Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)|The product acceptability and preference questionnaire (PAP-Q ) served as a patient satisfaction score and was performed only once at the final study visit (ie, after 12 weeks (V5) or earlier in case of premature termination). Severity of each facial acne sign and symptom (scaling, redness, dryness, burning, itching) was based on a 0-5 point rating scale (0- None, 1- Very minimal, 2- Mild, 3- Moderate, 4- Severe, 5- Very severe).|Week 12|MITT population.|||Participants|||Count of Participants
2610138|NCT02058628|Secondary|Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12|Tolerability was assessed by the participants based on a 0-3 point rating scale for stinging/burning (S/B) and pruritus of the face (0- None, 1- Slight, 2- Moderate and 3- Strong). A shift table was provided to deduce how the results are varying from the Baseline visit to post-baseline visits.|Baseline (Day 1), Weeks 2, 4, 8 and 12|MITT population.|||Participants|||Count of Participants
2610139|NCT02058628|Secondary|Number of Participants With Participant Global Change Assessment Score 12 Weeks|An SGCA was conducted by the participant to assess the efficacy of treatment on Week 2, 4, 8 and 12 as Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, Very Much Worse and missing.|Weeks 2, 4, 8 and 12|MITT population.|||Participants|||Count of Participants
2610140|NCT02058628|Secondary|Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12|Tolerability was assessed by investigator on a 0-3 point rating scale for erythema (0- None, 1- Slight, 2- Some and 3- Very red), dryness (0- None, 1- Slight, 2- Some and 3- Very dry) and peeling (0- None, 1- Slight, 2- Moderate and 3- Strong). A shift table was provided to deduce how the results are varying from the baseline visit to post-baseline visits. Change from Baseline is the value at indicated time point minus the Baseline value.|Baseline (Day 1) and Weeks 2, 4, 8, 12|MITT population.|||Participants|||Count of Participants
2610141|NCT02058628|Secondary|Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12|ISGA was conducted at all study visits. The area considered for the ISGA was confined to the face. A 0-5 point rating scale was used: 0 means Clear- Clear skin with no IL or NIL, 1 means Almost Clear- Rare NIL with no more than one small IL, 2 means Mild- Some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3 means Moderate- Up to many NIL and may have some IL, but no more than one small nodular lesion, 4 means Severe- Up to many NIL and IL, but no more than a few nodular lesions and 5 means Very Severe- Many NIL and IL and more than a few nodular lesions, may have cystic lesions.|Baseline (Day 1) up to Weeks 2, 4, 8, 12|MITT population.|||Participants|||Count of Participants
2610142|NCT02058628|Secondary|Speed of Onset : Time to 50 Percent Reduction in Total Lesion Count|The average time to 50 percent reduction of the calculated total lesion count was analyzed by determination of the number of days between Baseline and the first visit with a 50 percent reduction of the count.|Week 12|MITT population. Only those participants available at the indicated time points were analyzed.|||Days||Full Range|Median
2610143|NCT02058628|Secondary|Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12|A count of IL (papules and pustules, including nasal lesions),NIL (open and closed comedones) and total lesions was performed at baseline and up to Week 12. Lesion counts were confined to the face. Baseline was defined at Visit 1 (Day 1). Change from Baseline in the number of IL was defined as week 12 values minus the Baseline values.|Baseline (Day 1) up to Week 2, 4, 8, 12|MITT population. Only those participants available at the indicated time points were analyzed.|||Percent change||Standard Deviation|Mean
2610144|NCT02058628|Secondary|Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12|A count of IL (papules and pustules, including nasal lesions), NIL (open and closed comedones) and total lesions was performed at baseline and up to Week 12. Lesion counts were confined to the face. Baseline was defined at Visit 1 (Day 1). Change from Baseline in the number of IL was defined as week 12 values minus the Baseline values.|Baseline (Day 1) up to Week 2, 4, 8, 12|MITT population. Only those participants available at the indicated time points were analyzed.|||Lesions||Standard Deviation|Mean
2610145|NCT02058628|Primary|Percentage Change From Baseline (Day 1) of Inflammatory Lesion (IL) Count at Week 4 - Superiority Analysis|A count of IL (papules and pustules, including nasal lesions) was performed at baseline and up to Week 12. Lesion counts were confined to the face. Baseline was defined at Visit 1 (Day 1). Change from Baseline in the number of IL was defined as Week 4 values minus the Baseline values. Raw data has been presented for outcome measure results; however, p value is derived from the Wilcoxon test mean scores.|Baseline (Day 1) and Week 4|Modified intent-to-treat (MITT) population consisted of all participants in the ITT analysis set who had a baseline measurement of the number of IL and who had at least one post-baseline measurement of the number of IL.|||Percent change||Standard Deviation|Mean
2610147|NCT02058589|Secondary|Number of Subjects With Renal Allograft Rejection|Renal allograft rejection was confirmed through biopsy.|From 1 month post last vaccination (Month 2) until study end (Month 13).|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
2610148|NCT02058589|Secondary|Number of Subjects With Any pIMDs|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From 1 month post last vaccination (Month 2) until study end (Month 13).|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
2610149|NCT02058589|Secondary|Number of Subjects With Any and Related SAEs|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related = SAE assessed by the investigator as related to the vaccination.|From 1 month post last vaccination (Month 2) until study end (Month 13).|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.If a subject reported a SAE exactly 1 month post-last vaccination (Month 2), it is possible that he/she might have also been taken into consideration for the Day0 up to Month2 SAEs assessment|||Participants|||Count of Participants
2610150|NCT02058589|Secondary|Number of Subjects With a Vaccine Response for gE-specific CD4+ T-cells|Vaccine response for gE-specific CD4+ T-cells expressing at least two activation markers (from among IFN-γ, IL-2, TNF-α and CD40L), was determined by in vitro ICS. Vaccine response was defined as: For initially subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x<320> Events/10 million CD4+ T-cells); For initially subjects with pre-vaccination T-cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies.|At Months 2 and 13|The analysis was performed on the adapted ATP cohort for cell-mediated immunogenicity (CMI), which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and who were part of a CMI sub-cohort (Blood samples collected at Visits 1, 3 and 5 were analyzed to assess CMI response).|||Participants|||Count of Participants
2610151|NCT02058589|Secondary|Frequencies of gE-specific Cluster of Differentiation 4 (CD4+) T-cells|Descriptive statistics of gE-specific CD4+ T-cells, expressing at least two activation markers (from among interferon gamma [IFN-γ], interleukin-2 [IL-2], tumour necrosis factor alpha [TNF-α] and cluster of differentiation 40-ligand [CD40L]) were tabulated, as determined by in vitro Intracellular Cytokine Staining (ICS).|At Months 0, 2 and 13|The analysis was performed on the adapted ATP cohort for cell-mediated immunogenicity (CMI), which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and who were part of a CMI sub-cohort (Blood samples collected at Visits 1, 3 and 5 were analyzed to assess CMI response).|||gE-specific CD4+ T-cells/million T-cells||Standard Deviation|Mean
2610152|NCT02058589|Secondary|Number of Subjects With a Vaccine Response for Anti-gE Humoral Immunogenicity|Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination greater than or equal to (≥) 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. Vaccine response was determined by ELISA.|At Months 1, 7 and 13|The analysis was performed on the adapted ATP cohort for humoral immunogenicity, which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2610153|NCT02058589|Secondary|Anti-gE Antibody Concentrations|Varicella Zoster Virus (VZV) gE antibody Immunoglobulin G concentrations were determined by ELISA assay, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The reference seropositivity cut-off value was ≥ 97 mIU/mL.|At Months 0, 1, 2, 7 and 13|The analysis was performed on the adapted ATP cohort for humoral immunogenicity, which included all evaluable subjects up to Month 13, who did not meet any of the criteria for elimination from an ATP analysis, and for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2610154|NCT02058589|Primary|Number of Subjects With Changes in Allograft Function|Allograft function was indicated by the increase in levels of serum creatinine (≥ 1.20, ≥ 1.50, ≥ 1.75 or ≥ 2 fold increase). The number of subjects with declining allograft function, as determined by serum creatinine measurements post-vaccination (up to 30 days post-last vaccination) compared to pre-vaccination were presented.|From the first vaccination (Month 0) up to 1 month post last vaccination (Month 2).|The analysis was performed on subjects with pre and post vaccination serum creatinine data available up to Month 2, from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
2610155|NCT02058589|Primary|Number of Subjects With Renal Allograft Rejection|Renal allograft rejection was confirmed through biopsy.|From the first vaccination (Month 0) up to 1 month post last vaccination (Month 2).|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
2610156|NCT02058589|Primary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongatoion of hospitalization, or result in disability /incapacity. Related = SAE assessed by the investigator as related to the vaccination.|From first vaccination (Month 0) up to 1 month post last vaccination (Month 2).|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
2610157|NCT02058589|Primary|Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology|From first vaccination (Month 0) up to 1 month post last vaccination (Month 2).|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
2610180|NCT02058537|Other Pre-specified|Change From Baseline Composite Vital Signs to Day 7|Vital signs include temperature, heart rate, breathing rate, and blood pressure. This variables will be measured during the study in order to assess any negative systemic effects of the study drug. These measurements are assessed as a composite and not individually therefore are grouped together as one outcome measure.|Day 1 and Day 7|We did not do the data analysis since the originating PI left the institution and the study was terminated.||||||
2610158|NCT02058589|Primary|Number of Subjects With Unsolicited Symptoms (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
2610159|NCT02058589|Primary|Days With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)].|Within 7 days (Days 0-6) after each dose and overall/dose|The analysis was performed on the subjects with solicited general symptoms from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Days||Inter-Quartile Range|Median
2610160|NCT02058589|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)] . Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Gastrointestinal symptoms (Gastro. sympt.) included nausea, vomiting, diarrhoea and/or abdominal pain.|Within 7 days (Days 0-6) after each dose and across doses|The analysis was performed on the subjects with symptom sheets completed from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
2610161|NCT02058589|Primary|Days With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling.|Within 7 days (Days 0-6) after each dose and overall/dose|The analysis was performed on the subjects with solicited local symptoms from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Days||Inter-Quartile Range|Median
2610162|NCT02058589|Primary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Pain when limb was moved, which prevented everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within 7 days (Days 0-6) after each dose and across doses.|The analysis was performed on the subjects with symptom sheets completed from the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and documented.|||Participants|||Count of Participants
2610163|NCT02058589|Primary|Number of Subjects With a Vaccine Response for Anti-glycoprotein E (gE) Humoral Immunogenicity|Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination greater than or equal to (≥) 4 fold the cut-off for Anti-gE (4x97 milli-international units per milliliter [mIU/ml]); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. Vaccine response was determined by Enzyme-Linked ImmunoSorbent Assay (ELISA).|At Month 2.|The analysis was performed on the According-to-Protocol (ATP) cohort for humoral immunogenicity, which included all evaluable subjects up to Month 2, who did not meet any of the criteria for elimination from an ATP analysis, and for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2610164|NCT02058563|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.|Day 0 through the end of the study (Day 180)|Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2610165|NCT02058563|Secondary|Number of Subjects Reporting Adverse Events Prompting ER Visits|Occurrence of AEs prompting emergency room (ER) visits.|Day 0 through the end of the study (Day 180)|Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2610166|NCT02058563|Secondary|Number of Subjects Reporting NOCDs|Occurrence of new onset chronic diseases (NOCDs)|Day 0 through the end of the study (Day 180)|Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2610167|NCT02058563|Secondary|Number of Subjects Reporting Solicited Joint Pain (Arthralgia/Arthritis)|Assessed any, Grade-3, Related. Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination; Grade3 joint pain (arthralgia/arthritis)= Pain which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Related = symptom assessed by the investigator as causally related to study vaccination.|During the 43 days (Days 0-42) post-vaccination period.|Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.|||subjects|||Number
2610168|NCT02058563|Secondary|Number of Subjects Reporting Solicited Rash Symptom|Assessed any rash, Grade 3, Related, Localized rash, Generalized rash,measles/rubella-rash. Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination. Grade3 rash/exanthema= Rash which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Grade 3 measles/rubella/varicella-like rash = Rash with more than150 lesions. Related = symptom assessed by the investigator as causally related to study vaccination.|During the 43 days (Days 0-42) post-vaccination period.|Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.|||Subjects|||Number
2610169|NCT02058563|Secondary|Number of Subjects Reporting Unsolicited AEs|Any untoward medical occurrence in a patient or clinical investigation child, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|During the 43 days (Days 0-42) post-vaccination period.|Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2610170|NCT02058563|Secondary|Number of Subjects Reporting Solicited General Symptoms as Parotid/Salivary Gland Swelling and Any Sign of Meningism/Seizure.|Assessed MMR specific symptoms were parotid/salivary gland swelling and any sign of meningism/seizure. Parotid/salivary gland swelling: Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination; Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Meningism/seizure: Any= occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination; Grade-3 meningism/seizure= Prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Related symptom = symptom assessed by the investigator as causally related to study vaccination.|During the 43 days (Days 0-42) post-vaccination period.|Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.|||Subjects|||Number
2610171|NCT02058563|Secondary|Number of Subjects Reporting Fever|Fever was assessed:Any fever (≥38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination. Grade3 fever = fever >39.5°C. . Related = symptom assessed by the investigator as causally related to study vaccination.The preferred route for recording temperature in this study was oral.|During the 43 days (Days 0-42) post-vaccination period.|Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.|||Subjects|||Number
2610172|NCT02058563|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest. Prevented normal every day activities. Grade 3 redness = redness with surface diameter >50mm. Grade 3 swelling = swelling with surface diameter >50mm.|During the 4-day (Days 0-3) post-vaccination period|Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.|||Subjects|||Number
2610173|NCT02058563|Secondary|Number of Subjects Who Achieved a 4-fold or Greater Rise in Anti-measles, Anti-mumps and Anti-rubella Virus Antibody Concentrations.|For subjects with seronegative status at pre-vaccination, a 4-fold rise in antibody concentration is defined as 4 times the cut-off level of the assay. Cut-off levels for anti-measles, anti-mumps and anti-rubella virus antibody concentrations are 150 mIU/mL, 5 EU/mL and 4 IU/mL.|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.|||Subjects|||Number
2610174|NCT02058563|Secondary|Number of Subjects With Anti-rubella Virus Antibody Concentration Equal or Above the Threshold of 10 IU/mL (Seroresponse Rate).|"Seroresponse was defined as:~Anti-rubella virus antibody concentration equal to or above the threshold of 10 IU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42."|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.|||Subjects|||Number
2610175|NCT02058563|Secondary|Number of Subjects With Anti-mumps Virus Antibody Concentration Equal or Above the Threshold of 10 EU/mL (Seroresponse Rate).|"Seroresponse was defined as:~Anti-mumps virus antibody concentration equal to or above the threshold of 10 EU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42."|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.|||Subjects|||Number
2610176|NCT02058563|Secondary|Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Threshold of 200 mIU/mL (Seroresponse Rate)|"Seroresponse was defined as:~Anti-measles virus antibody concentration equal to or above the threshold of 200 mIU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42."|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.|||Subjects|||Number
2610177|NCT02058563|Primary|Anti-rubella Virus Antibody Concentrations.|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. Seropositivity was defined as subjects with anti-rubella virus antibody concentration equal or greater than 4 IU/mL|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.|||IU/mL||95% Confidence Interval|Geometric Mean
2610178|NCT02058563|Primary|Anti-mumps Virus Antibody Concentrations|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in EU/mL. Seropositivity was defined as subjects with anti-mumps virus antibody concentration equal or greater than 5 EU/mL|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.|||EU/mL||95% Confidence Interval|Geometric Mean
2610179|NCT02058563|Primary|Anti-measles Virus Antibody Concentrations.|Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in milli International Units per milliliter (mIU/mL). Seropositivity was defined as subjects with anti-measles virus antibody concentration equal or greater than 150 mIU/mL.|At Day 42|ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.|||mIU/mL||95% Confidence Interval|Geometric Mean
2610181|NCT02058537|Secondary|Change From Baseline Evaluation of Esophageal Function Questionnaire to Day 7|This questionnaire allows the patient to assess their own symptoms and report their opinions about drug effectiveness.|Day 1 and Day 7|We did not do the data analysis since the originating PI left the institution and the study was terminated.||||||
2610182|NCT02058537|Primary|Change From Baseline High Resolution Esophageal Manometry With Impedance to Day 7|The high resolution esophageal manometry with impedance involves a thin, pressure-sensitive tube that is passed through the nose and into the stomach. Once in place, the tube is pulled slowly back into the esophagus (food pipe). When the tube is in the esophagus, the patient is asked to swallow several times while swallowing water, applesauce, crackers, and marshmallows. These swallows will be completed while laying down, sitting upright, and standing. The pressure of the muscle contractions will be measured along several sections of the tube. The tube is removed after the tests are completed. This test allows for a quantitative measure of the pressure in the esophagus that can be correlated to difficulty or ease of bolus swallowing.|Day 1 and Day 7|We did not do the data analysis since the originating PI left the institution and the study was terminated.||||||
2610183|NCT02058511|Other Pre-specified|Hippus|We assess the effects of various anesthetic drugs on pupillary unrest (hippus). More specifically, we record pupil diameters over 20 seconds and then perform a Fourier Analysis of the diameter changes. The endpoint variable is power of the oscillations over certain predefined frequency bins.|Before anesthesia start (baseline measurement) until discharge of the patient (on average 1-2 hours after arrival in the recovery room)|||||||
2610184|NCT02058511|Secondary|Number of Patients we Were Able to Elicit a PLR Under Stable Experimental Conditions|"Pupillary Reflex Dilation is measured intraoperatively at incision and at the end of the case as a possible indicator of success of regional anesthesia.~Measurement of this requires stable experimental conditions, most notably sufficient depth of anesthesia."|measurements were taken at two time points during surgery. Each measurement took 30 seconds||||Participants|||Count of Participants
2610185|NCT02058511|Primary|Pain in Recovery Room|Pain as assessed by visual analogue score at arrival of the patient in the recovery room Scale goes from 0-10, with 10 indicating the worst pain possible|at arrival in recovery room||||score on a scale||Standard Deviation|Mean
2610186|NCT02058498|Secondary|Number of Patients Who Document Their Physical Activity|8 participants documented their physical activity at 6 weeks. 6 participants documented their physical activity at 4 months.|Baseline to 6 weeks, repeated measure at 4 months||||participants|||Number
2610187|NCT02058498|Secondary|Quality of Life at Baseline, 6 Weeks, and 4 Months|Participants reported their perceived quality of life using a scale 1 - 10, with 1 being the worst and 10 being the best.|Baseline, 6 weeks, 4 months||||units on a scale||Standard Deviation|Mean
2610188|NCT02058498|Primary|Physical Activity Measured by the International Physical Activity Questionnaire (IPAQ)|The IPAQ calculates the metabolic equivalent (MET) score by asking participants the days and minutes exercised in three categories of intensity (vigorous, moderate, and walking) during the previous one week. The following formula is used to calculate the MET: MET=8(vigorous activity) (minutes) + 4 (moderate activity)(minutes) +3.3 (walking activity) (minutes).|Baseline, 6 weeks||||MET||Full Range|Median
2610189|NCT02058368|Secondary|Number of Participants With Suicidal Ideation and Suicidal Behavior|Suicidality was assessed utilizing the Columbia Suicide Severity Rating Scale (C-SSRS). It included tabular summaries of suicidal ideation and suicidal behavior questions that were administered. Assessments were carried out at Screening, Month 6, Month 12, and Month 24 (or end of treatment) visits. C-SSRS included Question1-2 were for suicidal ideation Question 1: Passive: wish to be dead, Question 2: Active: Non-specific (no method, intent or plan). Questions 6-10 were for suicidal behavior, Question 6: Preparatory Acts or Behavior, Question 7: any aborted attempt, Question 8: Any interrupted attempts, Question 9: Any non-fatal actual suicide attempt, Question 10: Completed suicide. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|6, 12, 18 , 24 months and final assessment|ITT Population.|||Participants|||Count of Participants
2610190|NCT02058368|Secondary|Number of Participants With Clinically Significant Qualitative Breast Examination|Qualitative breast examination included palpable breast tissue and nipple tenderness. Here, participants with clinically significant abnormalities for palpable breast tissue and nipple tenderness are summarized. Qualitative breast examination was done at screening visit, Month 6, 12, 18 , 24 and final assessment (latest post-Baseline evaluation that was available). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|6, 12, 18 , 24 months and final assessment|ITT Population.|||Participants|||Count of Participants
2610191|NCT02058368|Secondary|Number of Participants With Digital Rectal Examination (DRE)|DRE evaluation was carried out from normal/diffusely enlarged at Baseline to focal abnormalities at any time post-Baseline. DRE was assessed at screening visit, Month 6, 12, 18 , 24 and final assessment is the latest post-Baseline evaluation that was available. Here, participants with focal abnormalities are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|6, 12, 18 , 24 months and final assessment|ITT Population.|||Participants|||Count of Participants
2610192|NCT02058368|Secondary|Number of Participants With Threshold Clinical Chemistry Value.|Clinical chemistry laboratory parameters assessed included albumin, alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), creatinine, glucose, potassium, sodium, total bilirubin, total protein and urea/blood urea nitrogen (BUN). Threshold factors are in the below table. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to 24 Months|ITT Population.|||Participants|||Count of Participants
2610193|NCT02058368|Secondary|Number of Participants With Threshold Hematology Value.|The threshold laboratory values are defined in terms of a multiplicative factor of the testing laboratory's normal range. A laboratory value that is above the upper limit factor multiplied by the upper limit of the normal (ULN) range is considered a high threshold value. A laboratory value that is below the lower limit factor multiplied by the lower limit of the normal (LLN) range is considered a low threshold value. Hematology laboratory parameters assessed included hemoglobin (Hgb), platelet count, white blood cell count (WBC) and red blood cell (RBC) count. Threshold factors are in the below table. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Up to 24 Months|ITT Population.|||Participants|||Count of Participants
2610206|NCT02058368|Secondary|Number of Participants With Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery|AUR is defined as condition when the participant is unable to urinate and requires bladder catheterization. AUR or BPH-related surgery event details per participant was summarized as first occurring of either AUR or BPH-related surgery.|Up to 24 Months|ITT Population.|||Participants|||Count of Participants
2610194|NCT02058368|Secondary|Change From Baseline in Post Void Residual Volume|Post void residual volume was measured suprapubically by ultrasound (immediately following the urinary flow measurement). Post void residual volume change from Baseline distribution at each scheduled post-Baseline assessment was compared with combination treatment (Dut plus Tam) versus tamsulosin treatment using a nonparametric van Elteren test. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline, 6, 12, 18 and 24 Months|ITT Population.|||mL||Standard Deviation|Mean
2610195|NCT02058368|Secondary|Number of Participants With Vital Signs Exceeding Threshold Values|Vital signs included assessment of systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate. Threshold ranges for SBP ranged from < 80 mmHg (millimeter of mercury) (lower) to > 165 mmHg (upper); for DBP ranged from < 40 mmHg (lower) to > 105 mmHg (upper) and heart rate < 40 beats per minute (bpm) (lower) to > 100 bpm (upper).|Up to 24 Months|ITT Population.|||Participants|||Count of Participants
2610196|NCT02058368|Secondary|Change From Baseline in Serum Prostate Specific Antigen (PSA)|Total serum PSA concentrations were assessed at pre-screening, month 6, 12 and 24. Change from baseline total PSA was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment at each scheduled post-baseline assessment using a general linear model with effects for treatment and baseline total PSA. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline 6, 12 and 24 Months|ITT Population.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2610197|NCT02058368|Secondary|Number of Participants With Non-serious Adverse Events (AE) and Serious AE (SAE)|An adverse event is defined as any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as resulting in death, life threatening, requires hospitalization or prolongation of hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation that is medically important, All events of possible drug-induced liver injury with hyperbilirubinaemia, male breast cancer and spontaneous abortion of a female partner of a male subject|Up to 24 Months|ITT Population.|||Participants|||Count of Participants
2610198|NCT02058368|Secondary|Number of Participants With Hospital Admissions|Details of participants who were admitted to hospitals related to AUR or BPH-Related surgery has been recorded.|Up to 24 Months|ITT Population. Only those participants with data available at specific time point were analyzed.|||Participants|||Count of Participants
2610199|NCT02058368|Secondary|Number of Participants in a Hospital Ward|Details of number of participants in different types of wards was recorded. Types of wards included general ward, recovery, intensive care unit, multiple ward types and others|Up to 24 Months|ITT Population. Only those participants with data available at specific time point were analyzed|||Participants|||Count of Participants
2610200|NCT02058368|Secondary|Number of Hospitalization Days|Duration of hospitalization days due to AUR or BPH-related surgery was recorded.|Up to 24 Months|ITT Population. Only those participants with data available at specific time point were analyzed|||Days||Full Range|Median
2610201|NCT02058368|Secondary|Change From Baseline in Problem Assessment Scale of the Sexual Function Inventory (PAS-SFI)|PAS SFI consists of three questions each with a range of 0 (Big Problem) to 4 (No Problem). PAS SFI was administered at screening, Baseline and at each month 12 and 24. The total PSI is the sum of the three questions; the total score range is 0 to 12. Change from Baseline PAS SFI at each scheduled post-baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline PAS SFI. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline, 12 and 24 Months|ITT Population.|||Scores on scale||Standard Deviation|Mean
2610202|NCT02058368|Secondary|Change From Baseline in BPH Impact Index (BII) by LOCF Approach|The BII consists of four questions and BII total score is the sum of four questions. Total score range is 0 (no problem) to 13 (worst value). Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline BII at each scheduled post-baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline BII. Change from Baseline was summarized using LOCF approaches.|Baseline 3, 6, 9, 12, 15, 18, 21 and 24 Months|ITT Population.|||Scores on scale||Standard Error|Mean
2610203|NCT02058368|Secondary|Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach|BHS was collected as Question 8 the IPSS questionnaire regarding quality of life due to urinary symptom with scores values ranging from 0 (delightful) to 6 (terrible). Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from baseline BHS at each scheduled post-baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline BHS.|Baseline, 3, 6, 9, 12, 15, 18, 21 and 24 Months|ITT Population.|||Scores on scale||Standard Deviation|Mean
2610204|NCT02058368|Secondary|Number of Participants With BPH-related Surgery|BPH-related interventions were recorded. BPH-related interventions included adenomectomy, balloon dilatation, electroresection, thermotherapy (microwave or radiofrequency), laser resection, prostatectomy, prostatotomy, transurethral resection of the prostate, transurethral drainage of prostatic abscess, drainage of prostatic cysts, radioactive seeding of the prostate, prostatic urethral stenting, incision of periurethral stricture, ethanol injections into the prostate, transrectal high intensity focussed ultrasound, transurethral needle ablation and transurethral microwave thermotherapy.|Up to 24 Months|ITT Population.|||Participants|||Count of Participants
2610205|NCT02058368|Secondary|Number of Subjects With AUR|AUR is defined as condition when the participant is unable to urinate and requires bladder catheterization.|Up to 24 Months|ITT Population.|||Participants|||Count of Participants
2610207|NCT02058368|Secondary|Number of Participants With Qmax Improvement From Baseline by LOCF Approach.|Qmax change from Baseline was presented using six improvement levels: >0 milliliter per second (mL/sec) and >=1 mL/sec through >=5mL/sec. Qmax percentage change from Baseline was presented using six improvement levels: >0%, >=10%, >=20%, >=30%, >=40%, and >=50%. Here, Qmax improvement of >= 3 mL/sec and Qmax percentage of >= 30 % for 24 Months has been summarized. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date.|Baseline 6, 12, 18 and 24 Months|ITT Population.|||Participants|||Count of Participants
2610208|NCT02058368|Secondary|Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach|Qmax is defined as maximum urine flow. Qmax was measured with Uroflow meter (Urodyn 1000) at Screening, Baseline, and at Months 6,12,18 and 24. Change from Baseline Qmax at each scheduled post-Baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline Qmax. Baseline value was defined as the latest non-missing assessment either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline, 6, 12, 18 and 24 Months|ITT Population|||milliliter per second (mL/sec)||Standard Error|Mean
2610209|NCT02058368|Secondary|Number of Participants With IPSS Improvement From Baseline|Improvement in IPSS was categorized as improvement, no change and worsening. Improvement defined as greater than or equal to 2 points, greater than or equal to 3 points and greater than or equal to 25 percent in participants at months 3,6,9,12,15,18,21 and 24 . Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline was reported based on the LOCF. Change from Baseline defined as difference between Post-Baseline value and Baseline value.|Baseline and 3, 6, 9,12,15,18,21 and 24 months|ITT Population.|||Participants|||Number
2610210|NCT02058368|Secondary|Percent Change in Prostate Volume From Baseline|Prostate Volume measurements were conducted annually using Transrectal ultrasound (TRUS). The following calculation was utilized to assess the prostate volume (cc): pi/6 (Anteroposterior Width multiplied by Cephalocaudal Width multiplied by Transverse Width). Post-Baseline prostate volume was calculated at 12 and 24 months. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline was reported based on the LOCF. Change from Baseline defined as difference between Post-Baseline value and Baseline value and reported as a percentage.|Baseline,12 and 24 months|ITT Population.|||Cubic centimeters (cc)||Standard Error|Mean
2610211|NCT02058368|Primary|Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months|IPSS (also called IPSS total score) is the sum of the seven questions with each score ranging from 0 (best) to 5 (worst). IPSS was self administered at screening, Baseline and each time-point of Month 3, 6, 9, 12, 15, 18, 21 and 24. Seven questions included are incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. The total IPSS score can range from 0-35 with severity catagories of mild (0 to 7), moderate (8 to 19) or severe (20 to 35). LOCF is defined as carrying forward the last non-missing post-Baseline assessment for participants with missing visit data and/or for participants who discontinued from the study. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date. Month 24 is the primary timepoint and earlier timepoints are considered secondary. Change from Baseline defined as difference between Post-Baseline value and Baseline value.|Baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months|ITT Population.|||Score on scale||Standard Error|Mean
2610212|NCT02058290|Secondary|Patient Satisfaction With Pain Treatment After Surgery|Responses to question pertaining to patient satisfaction with pain treatment|Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.|||participants|||Number
2610213|NCT02058290|Secondary|Incidence of Opioid-related Adverse Events|Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.|Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.|||participants|||Number
2610214|NCT02058290|Primary|Health Economic Benefits - Length of Stay (LOS)|Length of stay, recorded in days, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure at time hospital discharge order is written or Day 30, whichever is sooner|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.|||days||Full Range|Median
2610215|NCT02058290|Primary|Health Economic Benefits - Total Cost of Hospitalization|Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever was sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.|||dollars||Standard Deviation|Mean
2610216|NCT02058290|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Of the 77 subjects who were enrolled in Group 1, 56 were included in the efficacy analysis set. Of the 45 subjects who were enrolled in Group 2, 26 were included in the efficacy analysis set.|||mg||Standard Deviation|Mean
2610217|NCT02058251|Secondary|Stress Reactivity|Salivary Cortisol (μg/dL). Greater cortisol levels are indicative of greater stress reactivity.|2 hours|Main outcomes analyses were limited to male participants.|||μg/dL||Standard Deviation|Mean
2614832|NCT02006758|Secondary|Mean Change in Office Diastolic Blood Pressure at 6 Months||Baseline and 6 months|58 out of 67 participants analyzed for mean change in office Diastolic Blood Pressure at 6 months|||mmHg||Standard Deviation|Mean
2610218|NCT02058251|Primary|Alcohol Craving|Using the Visual Analogue Scale (VAS), participants provided self-report ratings of subjective alcohol cravings on a scale of 1-10, with one being the lowest/better score, and 10 being the highest/worst outcome.|2 hours|Main outcomes analyses were limited to male participants.|||scores on a scale||Standard Deviation|Mean
2610219|NCT02058160|Secondary|Percentage of Participants With Severe Symptomatic Hypoglycemia|Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Plasma glucose measurements might not had been available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal was considered sufficient evidence that the event had been induced by a low plasma glucose concentration. Severe symptomatic hypoglycemia included all episodes in which neurological impairment was severe enough to prevent self-treatment, and which were thus thought to place participants at risk for injury to themselves or others.|First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])|Analysis was performed on safety population.|||percentage of participants|||Number
2610220|NCT02058160|Secondary|Percentage of Participants With Documented Symptomatic Hypoglycemia|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])|Analysis was performed on safety population.|||percentage of participants|||Number
2610221|NCT02058160|Secondary|Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|First dose of study drug up to 1 day after the last dose administration (median treatment exposure 211 days [FRC], 210 days [Insulin glargine])|Analysis was performed on safety population defined as all randomized participants who received at least one dose of IMP regardless of the amount of treatment administered.|||events per subject-year|||Number
2610222|NCT02058160|Secondary|Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values - from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%.|Baseline up to Week 30|mITT population.|||percentage of participants|||Number
2610223|NCT02058160|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|Baseline up to Week 30|mITT population. Participants with no value for HbA1c at Week 30 were counted as non-responders.|||percentage of participants|||Number
2610224|NCT02058160|Secondary|Change in 2-hour PPG From Baseline to Week 30|Change in PPG was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed= participants with baseline and at least one post-baseline PPG assessment during study period.|||mmol/L||Standard Error|Least Squares Mean
2610225|NCT02058160|Secondary|Change in FPG From Baseline to Week 30|Change in FPG was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed= participants with baseline and at least one post-baseline FPG assessment during study period.|||mmol/L||Standard Error|Least Squares Mean
2610226|NCT02058160|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|Baseline up to Week 30|mITT population. Participants without HbA1c and/or body weight value at Week 30 were counted as non-responders.|||percentage of participants|||Number
2610227|NCT02058160|Secondary|Change in Daily Insulin Glargine Dose From Baseline to Week 30||Baseline, Week 30|mITT population. The analysis included scheduled measurements obtained up to the date of last injection of IMP. Here, number of participants analyzed= participants with insulin glargine dose assessment during study period.|||Units (U)||Standard Error|Least Squares Mean
2610228|NCT02058160|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30||Week 30|mITT population. Participants without HbA1c and/or body weight value at Week 30 were counted as non-responders.|||percentage of participants|||Number
2610229|NCT02058160|Secondary|Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30|Participants recorded a 7-point plasma glucose profile measured before and 2-hours after each meal and at bedtime, two times in a week before baseline, before visit Week 12 and before visit Week 30 and the average value across the profiles performed in the week before a visit for the 7 time points was calculated. Change in average 7 point SMPG was calculated by subtracting baseline value from Week 30 value. The analysis included all scheduled measurements obtained during the study. The missing data was handled by mixed effect model with repeated measures (MMRM) approach.|Baseline, Week 30|mITT population. Here, number of participants analyzed= participants with baseline and at least one post-baseline 7-point SMPG assessment during study period.|||mmol/L||Standard Error|Least Squares Mean
2610230|NCT02058160|Secondary|Change in Body Weight From Baseline to Week 30|Change in body weight was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during study period.|||kg||Standard Error|Least Squares Mean
2610264|NCT02057952|Secondary|Change in Diastolic Blood Pressure Baseline to 12 Months|Diastolic blood pressure change from baseline to 12 months. Measured using blood pressure cuff and sphygmomanometer. Units in Milometers of Mercury (mmHg). Scale range is based on participants' actual blood pressure (change baseline to 12 months; negative value indicates decrease in blood pressure).|12 Months|Participants who completed 12 month follow-up|||mmHg||Standard Deviation|Mean
2610231|NCT02058160|Secondary|Change in 2-hour Plasma Blood Glucose Excursion From Baseline to Week 30|Plasma glucose excursion = 2-hour postprandial glucose (PPG) minus plasma glucose value obtained 30 minutes prior to the start of the meal and before investigational medicinal product (IMP) administration, if IMP was injected before breakfast. Change in plasma glucose excursions was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline plasma glucose excursion assessment during study period. Missing data was imputed using last observation carried forward (LOCF).|||mmol/L||Standard Error|Least Squares Mean
2610232|NCT02058160|Secondary|Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30||Week 30|mITT population. Participants with no value for HbA1c at Week 30 were counted as non-responders.|||percentage of participants|||Number
2610233|NCT02058160|Primary|Change in Glycated Hemoglobin (HbA1c) From Baseline to Week 30|Change in HbA1c was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|Modified intent-to-treat (mITT) population: all randomized participants who had both baseline and at least one post-baseline efficacy assessment. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during study period.|||percentage of HbA1c||Standard Error|Least Squares Mean
2610234|NCT02058147|Secondary|Percentage of Participants With Severe Symptomatic Hypoglycemia|Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Plasma glucose measurements might not have been available during such an event, but neurological recovery attributable to the restoration of plasma glucose to normal was considered sufficient evidence that the event had been induced by a low plasma glucose concentration. Severe symptomatic hypoglycemia included all episodes in which neurological impairment was severe enough to prevent self-treatment, and which were thus thought to place participants at risk of injury to themselves or others.|First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)|Safety population.|||percentage of participants|||Number
2610235|NCT02058147|Secondary|Percentage of Participants With Documented Symptomatic Hypoglycemia|Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤ 70 mg/dL (3.9 mmol/L).|First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)|Safety population.|||percentage of participants|||Number
2610236|NCT02058147|Secondary|Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year|Documented symptomatic hypoglycemia was an event during which symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤ 70 mg/dL (3.9 mmol/L).|First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days)|Analysis was performed on safety population defined as all randomized participants who received at least one dose of IMP regardless of the amount of treatment administered.|||Events per subject-year|||Number
2610237|NCT02058147|Secondary|Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) was performed. Threshold values - from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%.|Baseline up to Week 30|mITT population.|||percentage of participants|||Number
2610238|NCT02058147|Secondary|Percentage of Participants Reaching HbA1c <7.0% at Week 30 With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). The analysis included all HbA1c measurements at Week 30, including those obtained after the IMP discontinuation or the introduction of rescue medication.|Baseline up to Week 30|mITT population. Participants without Week 30 value for HbA1c were counted as non-responders.|||percentage of participants|||Number
2610239|NCT02058147|Secondary|Change in 2-Hour Postprandial Plasma Glucose (PPG) From Baseline to Week 30|The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 30 value. Missing data was imputed using LOCF.|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline 2-hour PPG assessment during study period.|||mmol/L||Standard Error|Least Squares Mean
2610240|NCT02058147|Secondary|Average Daily Insulin Glargine Dose at Week 30|The analysis included scheduled measurements obtained up to the date of last injection of the IMP, including those obtained after introduction of rescue therapy.|Week 30|mITT population. Here, number of participants analyzed = participants with insulin glargine dose assessment during study period. Data of this endpoint was planned to be analyzed for Insulin Glargine/Lixisenatide FRC and Insulin glargine arms only, not for lixisenatide arm.|||Units (U)||Standard Error|Least Squares Mean
2610241|NCT02058147|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).|Baseline up to Week 30|mITT population. Participants without any HbA1c and/or body weight value at Week 30 were counted as non-responders.|||percentage of participants|||Number
2610242|NCT02058147|Secondary|Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30||Week 30|mITT population. Participants without any HbA1c and/or body weight value at Week 30 were counted as non-responders.|||percentage of participants|||Number
2610262|NCT02058069|Primary|Intra-Operative Complications|Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.|Subjects will be assessed for incidence of intra-operative complications at the conclusion of their hospital stay, or an average of 3 days post-operatively.|participants = knees.|||intra-operative complications|||Number
2610243|NCT02058147|Secondary|Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30|Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 12 and before visit Week 30 and the average value across the profiles performed in the week before a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 30 value. The analysis included all scheduled measurements obtained during the study. The missing data was handled by mixed effect model with repeated measures (MMRM) approach.|Baseline, Week 30|mITT population. Here,number of participants analyzed = participants with baseline and at least one post baseline 7-point SMPG assessment during study period.|||mmol/L||Standard Deviation|Least Squares Mean
2610244|NCT02058147|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 30|Change in FPG was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analysed = participants with baseline and at least one post-baseline FPG assessment during study period.|||mmol/L||Standard Error|Least Squares Mean
2610245|NCT02058147|Secondary|Change in Body Weight From Baseline to Week 30|Change in body weight was calculated by subtracting baseline value from Week 30 value.|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during study period.|||kg||Standard Error|Least Squares Mean
2610246|NCT02058147|Secondary|Change in Plasma Glucose Excursion From Baseline to Week 30|Plasma glucose excursion = 2-hour postprandial plasma glucose (PPG) value minus plasma glucose value obtained 30 minutes prior to the start of meal and before investigational medicinal product (IMP) administration if IMP was injected before breakfast. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 30 value. Missing data was imputed using last observation carried forward (LOCF).|Baseline, Week 30|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline plasma glucose excursion assessment during study period.|||mmol/L||Standard Error|Least Squares Mean
2610247|NCT02058147|Secondary|Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30|Participants without Week 30 value for HbA1c were counted as non-responders.|Week 30|mITT population.|||percentage of participants|||Number
2610248|NCT02058147|Primary|Change in HbA1c From Baseline to Week 30|"Primary outcome was to test superiority of FRC versus Lixisenatide and non-inferiority versus Insulin glargine.~Change in HbA1c was calculated by subtracting baseline value from Week 30 value."|Baseline, Week 30|Modified intent-to-treat (mITT) population: all randomized participants who had both baseline and at least one post-baseline efficacy assessment. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during study period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2610249|NCT02058108|Secondary|Number of Participants With On-Treatments Adverse Events, Serious Adverse Events, and Death|"Evaluation of the safety and tolerability of Telbivudine defined by AEs, SAEs, adverse events of special interest (AESI) (including muscle related events) and death; laboratory evaluations specifically on-treatment and post-treatment ALT flares, incidence and clinical significance of CK elevations; growth and development (linear growth and sexual maturation); development of liver decompensation and/or HCC.~Only descriptive analysis performed."|From first dose of study treatment to 30 days after last dose of study treatment, up to 112 weeks|The Safety Set, which consisted of all patients who received at least one dose of study drug during the treatment period, was considered.|||Participants|||Count of Participants
2610250|NCT02058108|Secondary|Number of Participants With Treatment Emergent Genotypic Resistance Associated With VB, or in Patients With HBV DNA≥300 Copies/mL (51 IU/mL) at Week 24 and Discontinued From the Study|Assessment of the presence of treatment emergent genotypic resistance (confirmed by genotypic sequencing) associated with virological breakthrough over the study period, or in patients with HBV DNA≥300 copies/mL (51 IU/mL) at Week 24 and discontinued from the study treatment (or at discontinuation if prior to Week 24 for subjects with at least 16 weeks of LDT treatment)|Week 24|The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. Only patients with efficacy data within censoring date included in the analysis.|||Participants|||Count of Participants
2610251|NCT02058108|Secondary|Number of Patients Achieving Cumulative Rate of Virological Breakthrough (VB) at Week 52 and 104|"The assessment of virological breakthrough (VB) was to be evaluated by: a) the cumulative rate of patients with confirmed VB at Week 52 and Week 104; b) the time to VB.~Due to early termination of the study and limited number of enrolled patients on track to complete 52 weeks of participation (8 patients overall), only descriptive analysis performed at Week 52 and Week 104."|Week 52, Week 104|The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. Only patients with efficacy data within censoring date included in the analysis.|||Participants|||Count of Participants
2610252|NCT02058108|Secondary|Number of Patients Achieving a Composite Endpoints (HBV DNA < 300 Copies/mL (51 IU/mL), ALT Normalization and HBeAg Seroconversion) at Week 52 and 104|"The proportion of patients achieving composite endpoints at Week 52 and 104 was to be evaluated by the proportion of patients achieving: a) HBV DNA <300 copies/mL (51 IU/mL); b) ALT normalization and HBeAg seroconversion for HBeAg positive patients only; c) HBV DNA <300 copies/mL (51 IU/mL) and ALT normalization for HBeAg negative patients.~Due to early termination of the study and limited number of enrolled patients on track to complete 52 weeks of participation (8 patients overall), only descriptive analysis performed at Week 52 and Week 104."|Week 52, Week 104|The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. Only patients with efficacy data within censoring date included in the analysis.|||Participants|||Count of Participants
2610263|NCT02058069|Primary|Intra-Operative Complications|Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.|Subject will be assessed for these complications intra-operatively. The assessment occurs after the surgeon has completed the surgical procedure, but while the subject is still in the operating room with the surgeon.|participants = knees.|||intra-operative complications|||Number
2610253|NCT02058108|Secondary|Number of Patients With HBsAg Loss, HBsAg Seroconversion at Week 24, 52 and 104|"The serological response at Weeks 24, 52 and 104 was to be evaluated by: a) the proportion of HBeAg positive patients at baseline who subsequently have HBeAg loss and HBeAg seroconversion (defined as loss of HBeAg with detectable HBeAb); b) the proportion of HBsAg positive patients at baseline who subsequently have HBsAg loss and HBsAg seroconversion (defined as loss of HBsAg with detectable HBsAb).~Due to early termination of the study and limited number of enrolled patients on track to complete 52 weeks of participation (8 patients overall), only descriptive analysis performed at Week 52 and Week 104."|Week 24, Week 52, Week 104|The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. Only patients with efficacy data within censoring date included in the analysis.|||Participants|||Count of Participants
2610254|NCT02058108|Secondary|Number of Patients With HBeAg Loss, HBeAg Seroconversion at Week 24, 52 and 104|"The serological response at Weeks 24, 52 and 104 was to be evaluated by: a) the proportion of HBeAg positive patients at baseline who subsequently have HBeAg loss and HBeAg seroconversion (defined as loss of HBeAg with detectable HBeAb); b) the proportion of HBsAg positive patients at baseline who subsequently have HBsAg loss and HBsAg seroconversion (defined as loss of HBsAg with detectable HBsAb).~Due to early termination of the study and limited number of enrolled patients on track to complete 52 weeks of participation (8 patients overall), only descriptive analysis performed at Week 52 and Week 104."|Week 24, Week 52, Week 104|The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. Only patients with efficacy data within censoring date included in the analysis.|||Participants|||Count of Participants
2610255|NCT02058108|Secondary|Number of Patients Whose Baseline ALTs Were Abnormal and Subsequently Normalized at Week 24, 52 and 104|"The biochemical response at Weeks 24, 52 and 104 was to be evaluated by the proportion of patients whose baseline ALTs were abnormal (defined as ALT >1 x Upper Limit of Normal [ULN]) and subsequently normalized.~Due to early termination of the study and limited number of enrolled patients on track to complete 52 weeks of participation (8 patients overall), only descriptive analysis performed at Week 52 and Week 104."|Week 24, Week 52, Week 104|The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. Only patients with efficacy data within censoring date included in the analysis.|||Participants|||Count of Participants
2610256|NCT02058108|Secondary|Number of Patients Achieving HBV DNA< 300 Copies/mL (51 IU/mL) at Week 52 and Week 104|"The antiviral efficacy at Weeks 52 and 104 was to be evaluated by: a) the proportion of patients achieving HBV DNA <300 copies/mL (51 IU/mL) at Week 52 and Week 104; b) the proportion of patients achieving HBV DNA < Lower Limit of Quantification (LLOQ), <1000 copies/ml (or 200 IU/mL), <10,000 copies/ml (or 2 000 IU/mL) and ≥10,000 copies/mL (or 2 000 IU/mL) at Week 24, 52 and 104; c) the proportion of patients achieving Serum HBV DNA reduction from baseline; d) the time to achieve HBV DNA <300 copies/mL (51 IU/mL); e) the proportion of patients with Primary non-response.~Due to early termination of the study and limited number of enrolled patients on track to complete 52 weeks of participation (8 patients overall), only descriptive analysis performed at Week 52 and Week 104."|Week 52, Week 104|The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered. Only patients with efficacy data within censoring date included in the analysis.|||Participants|||Count of Participants
2610257|NCT02058108|Primary|Number of Patients Achieving Serum HBV DNA Level of <300 Copies/mL (51 IU/mL) at Week 24|The primary objective of this study was to demonstrate the antiviral efficacy of telbivudine compared to placebo in pediatric patients (2- < 18 years) by determining the percentage of patients achieving serum HBV DNA level of <300 copies/mL (51 IU/mL) at Week 24.|Week 24|The Full Analysis Set (FAS), which consisted of all randomized patients to whom study treatment had been assigned, was considered.|||Participants|||Count of Participants
2610258|NCT02058069|Other Pre-specified|Patient Satisfaction - Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)|"The WOMAC collects information specific to osteoarthritis outcomes. The patient-response questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and function. Each question is scored from 0 to 4 for each set of factors, with 0 indicating no pain, stiffness, or limit in function, and 4 indicating extreme pain, stiffness, or limit in function. Total WOMAC scores range from 0 to 96 with lower values representing better outcomes.~The posted mean, noted as a negative number, represents the mean DECREASE in total WOMAC score from pre-operative to 3 month post-operative patient assessment."|Pre-Op, 3 Month Post Op [change assessed between the two time periods]|participants = knees.|||units on a scale||Standard Deviation|Mean
2610259|NCT02058069|Secondary|Participants With Limb Alignment Difference <4.38 Degrees|The difference between the actual 3 month limb alignment was compared to the pre-op planned alignment. Any measurement difference <4.38 was considered a success; >4.38 degrees was considered a failure.|Pre-op Plan, 3 Month Post Op|Participants = knees|||Participants|||Count of Participants
2610260|NCT02058069|Secondary|Change in the Radiographic Assessment of Limb Alignment From Pre-Operative to 3 Months Post-Operative|Radiographic limb alignment of the operative knee according to the technique defined by Barrack et al. was assessed at the 3 month post-operative follow-up by two independent reviewers. The measured post-operative limb alignment was to be compared to the planned pre-operative limb alignment as extracted from the system log file.|pre-op plan, 3 Month Post Op|Of the 89 patients who received a robotic assisted total knee arthroplasty as part of the IDE, 2 patients were excluded from analysis for the Secondary Endpoint only due to issues related to the accurate measurement of limb alignment from the radiographs available (not for reasons involving the surgical procedure or clinical outcomes).|||degrees||Standard Deviation|Mean
2610261|NCT02058069|Primary|Intra-Operative Complications|Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability.|3 Month Post Op|participants = knees.|||intra-operative complications|||Number
2610265|NCT02057952|Secondary|Change in Diastolic Blood Pressure at 6 Months|Change in pressure from baseline to 6 months|6 Months||||mmHg||Standard Deviation|Mean
2610266|NCT02057952|Secondary|Change in Systolic Blood Pressure|Change in pressure from baseline to 6 months|6 Months||||mmHg||Standard Deviation|Mean
2610269|NCT02057952|Secondary|Change in Systolic Blood Pressure|Systolic blood pressure. Measured using blood pressure cuff and sphygmomanometer. Units in Milometers of Mercury (mmHg). Scale range is based on participants' actual blood pressure (change baseline to 12 months). Negative value indicates decrease in blood pressure.|12 Months|Participants who completed 12 month follow-up|||mmHg||Standard Deviation|Mean
2610270|NCT02057952|Secondary|Change in Short Form 36 Survey Score|The Short Form 36 survey or Short-Form 36 is a patient report survey. Scores range from 0 (worst) to 100 (best) and represent overall health-related quality of life.|Baseline to 12 Months|The analysis of change based on participants with complete Short Form 36 (SF36) scores at baseline and 12 months.|||score on scale||Standard Deviation|Mean
2610271|NCT02057952|Primary|Change in Body Weight From Baseline to 6 Months.|Change in body weight from baseline to 6 months.|12 months|Analysis are based on number of participants with complete weight data at baseline and 6 months.|||pounds||Standard Deviation|Mean
2610272|NCT02057952|Primary|Attendance Reported in Minutes|Minutes of participation in study sessions.|12 Months|Usual care participants didn't have access to the experimental treatments. In person and video conference arm participants were all eligible for participation.|||minutes||Full Range|Median
2610273|NCT02057952|Primary|Body Weight|Change in weight from baseline to 12 months reported in pounds.|Baseline to 12 Months|The number of participants analyzed is based on the number of participants who completed weight data at baseline and 12 months.|||pounds||Standard Deviation|Mean
2610274|NCT02057939|Secondary|Number of Patients With Adverse Events Related to Combination Enzalutamide, ADT, and XRT|Safety and tolerability will be assessed using CTCAE v4.0|3 years||||participants|||Number
2610275|NCT02057939|Secondary|Time to Testosterone Recovery|Percentage of patients with recovering testosterone to > 100 at 1, 2, and 3 years.|3 years|One patient did not receive radiotherapy due to continual scar tissue development surrounding the ureters. This patient is not considered for analyses.|||percentage|||Number
2610276|NCT02057939|Secondary|PSA Nadir|Median PSA nadir post-radiation therapy|8 weeks|One patient did not receive radiotherapy due to continual scar tissue development surrounding the ureters. This patient is not considered for analyses.|||ng/ml||Full Range|Median
2610277|NCT02057939|Secondary|Biochemical Progression-free Survival|Percentage of patients surviving 2 and 3 years from the start of study treatment without progression of disease. Biochemical PFS was defined as the time from the date of study treatment initiation to the date of first documented progression or death due to any cause. Progression-free was defined as being without one of the following: serum PSA value of 0.2 ng/mL or more above post-radiotherapy PSA nadir that continues to increase 4 weeks later OR if no nadir is experienced, two rising PSA values over 4 or more weeks|3 years|One patient did not receive radiotherapy due to continual scar tissue development surrounding the ureters. This patient is not considered for analyses.|||percentage||95% Confidence Interval|Number
2610278|NCT02057939|Secondary|Three Year Progression-free Survival|Percentage of patients surviving 3 years from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of first documented progression or death due to any cause. Progression-free was defined as being without one of the following: serum PSA value of 0.2 ng/mL or more above post-radiotherapy PSA nadir that continues to increase 4 weeks later OR if no nadir is experienced, two rising PSA values over 4 or more weeks OR evidence of clinical progression or initiation of systemic therapy for progressive disease|3 years|One patient did not receive radiotherapy due to continual scar tissue development surrounding the ureters. This patient is not considered for analyses.|||percentage||95% Confidence Interval|Number
2610279|NCT02057939|Secondary|PSA Less Than 0.1|The percentage of men with PSA less than 0.1 ng/mL and testosterone greater than 100|every year, up to 3 years|One patient did not receive radiotherapy due to continual scar tissue development surrounding the ureters. This patient is not considered for analyses. Note that 11 patients did not have PSA measurements at 2 years and 24 did not have PSA measurements at 3 years. They are still included in the denominator.|||percentage|||Number
2610280|NCT02057939|Primary|Two Year Progression-free Survival|Percentage of patients surviving 2 years from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of first documented progression or death due to any cause. Progression-free was defined as being without one of the following: serum PSA value of 0.2 ng/mL or more above post-radiotherapy PSA nadir that continues to increase 4 weeks later OR if no nadir is experienced, two rising PSA values over 4 or more weeks OR evidence of clinical progression or initiation of systemic therapy for progressive disease|2 years|One patient did not receive radiotherapy due to continual scar tissue development surrounding the ureters. This patient is not considered for analyses.|||percentage||95% Confidence Interval|Number
2610281|NCT02057874|Secondary|Correlation of Changes in Ktrans, ADC, MTR, and APTasym (Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively) With Overall Survival (OS)|Proportional hazard model will be employed to assess the ability of the longitudinal change (relative to pretreatment baseline) in each of the 3T MR imaging metrics (Ktrans, ADC, MTR, and APTasym) to predict patient survival outcomes, time-to-progression (TTP) and progression-free survival (PFS) as well as overall survival (OS). The calibration of prediction will be validated by computing the difference between predicted survival and Kaplan-Meier survival estimates at a fixed time, which estimates the over-optimism of the difference using bootstrapping.|Baseline to up to 6 months post-TACE|Due to loss of funding data were not collected||||||
2610282|NCT02057874|Secondary|Correlation of Ktrans, ADC, MTR, and APTasym (Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively) With Pathological Response Within Explanted Tissue Following Orthotopic Liver Transplant (OLT)|Histopathological features on explanted livers following OLT, including percentage necrosis and cellular density as determined by hematoxylin and eosin staining, as well as the extent of fibrosis as determined by collagen staining, will be assessed for correspondence with findings on ex vivo 3T MRI.|Subset of patients undergoing OLT: within 12 hours following surgery|Due to loss of funding data were not collected||||||
2610293|NCT02057835|Secondary|Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax)|Time from (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||hours||Full Range|Median
2610283|NCT02057874|Secondary|Correlation of Changes in Ktrans, ADC, MTR, and APTasym (Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively) With Changes in the Ratio of Viable-to-necrotic Tumor Volume|Longitudinal changes in 3T MRI-derived measures and the change in the ratio of viable vs. necrotic tumor will be assessed by using a GLM approach in which the underlying temporal correlation can be modeled via an autoregressive order one (AR(1)) structure, validated by computing Akaike Information Criterion (AIC) against the other common structures, e.g., unstructured and constant correlation.|Baseline to up to 12 weeks post-TACE|Due to loss of funding data were not collected||||||
2610284|NCT02057874|Secondary|Correlation of Changes in Ktrans, ADC, MTR, and APTasym (Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively) With Time-to-progression (TTP).|Proportional hazard model will be employed to assess the ability of the longitudinal change (relative to pretreatment baseline) in each of the 3T MR imaging metrics (Ktrans, ADC, MTR, and APTasym) to predict patient survival outcomes, time-to-progression (TTP) and progression-free survival (PFS) as well as overall survival (OS). The calibration of prediction will be validated by computing the difference between predicted survival and Kaplan-Meier survival estimates at a fixed time, which estimates the over-optimism of the difference using bootstrapping.|Baseline to up to 6 months post-TACE|Due to loss of funding data were not collected||||||
2610285|NCT02057874|Primary|Correlation of Changes in Imaging Biomarkers (Ktrans, ADC, MTR, and APTasym) as Measured by DCE-, DW-, MT-, and CEST-MRI at 3 Tesla, Respectively, With Changes in Tumor Volume (mRECIST).|The following will be longitudinally measured using 3 Tesla (3T) magnetic resonance imaging (MRI) prior to transarterial chemoembolization (TACE) and 2-4, 4-8, and 12 weeks following TACE: 1) the volume transfer coefficient (Ktrans), measured by dynamic contrast-enhanced (DCE) MRI; 2) the apparent diffusion coefficient (ADC), measured by diffusion-weighted (DW) MRI; 3) the magnetization transfer ratio (MTR), measured by magnetization transfer (MT) MRI; and 4) the amide proton transfer asymmetry (APTasym), measured by chemical exchange saturation transfer (CEST) MRI. We will use a general linear model (GLM) approach to measure the association between changes in each of the above imaging metrics (relative to pretreatment baseline) and changes in tumor volume (according to standard-of-care modified RECIST) at 3 or 6 month follow-up, accounting for the effect of potential confounders, e.g., age and size of the tumor at baseline.|Baseline to up to 12 weeks post-TACE|Due to loss of funding data were not collected||||||
2610286|NCT02057835|Secondary|Terminal Half-life of the Analyte (T1/2) - Overall|Terminal half-life (T1/2) of the analyte in plasma/whole blood for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||hours||Geometric Coefficient of Variation|Geometric Mean
2610287|NCT02057835|Secondary|Terminal Half-life of the Analyte (T1/2)|Terminal half-life (T1/2) of the analyte in plasma/whole blood|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||hours||Geometric Coefficient of Variation|Geometric Mean
2610288|NCT02057835|Secondary|Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz) - Overall|Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2610289|NCT02057835|Secondary|Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2610290|NCT02057835|Secondary|Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) - Overall|Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 extrapolated to infinity for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2610291|NCT02057835|Secondary|Area Under the Concentration-time Curve of the Analyte Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)|Area under the concentration-time curve of the analyte in plasma/whole blood over the time interval from 0 extrapolated to infinity (AUC0-infinity)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2610292|NCT02057835|Secondary|Time From Dosing to the Maximum Measured Concentration of the Analyte (Tmax) - Overall|Time from (last) dosing to the maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||hours||Full Range|Median
2610313|NCT02057757|Secondary|Number of Participants Who Require Oxygen Use|Number of study participants who require use of supplemental oxygen at time points (e.g., Any time, Day 0, Day 3, Day 7, Day 14, and Day 28)|Measured through Day 28 or participants' last day of hospitalization||||Participants|||Count of Participants
2610294|NCT02057835|Secondary|Maximum Measured Concentration of the Analyte (Cmax) - Overall|Maximum measured concentration of the analyte in plasma/whole blood for all participants (Chinese and Japanese)|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2610295|NCT02057835|Secondary|Maximum Measured Concentration of the Analyte (Cmax)|Maximum measured concentration of the analyte in plasma/whole blood|1 hour (h) before drug administration and 20minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 288h and 336h after drug administration|All subjects of the treated set with the pharmacokinetic (PK) parameter calculated.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2610296|NCT02057835|Primary|Percentage of Participants With Drug Related Adverse Events|Percentage of participants with drug related adverse events (AEs)|From drug administration until 31 days after drug administration, 31 days|Treated set|||Percentage of participants|||Number
2610297|NCT02057757|Secondary|Hematologic Laboratory Assessments (WBC, Platelets) on Days 3, 7, and 28|Lab values for hematology laboratory assessments (e.g., WBC and Platelets) on Days 3, 7, and 28.|Measured on Day 3, Day, 7 and Day 28|This analysis was based on the Intent to Treat (ITT) population.|||10^3 cells/mcL||Standard Deviation|Mean
2610298|NCT02057757|Secondary|Hematologic Laboratory Assessment (Hemoglobin) on Days 3, 7, and 28|Hematology laboratory assessment (e.g., Hemoglobin) on Days 3, 7, and 28.|Measured on Day 3, Day, 7 and Day 28|This analysis was based on the Intent to Treat (ITT) population.|||g/dL||Standard Deviation|Mean
2610299|NCT02057757|Secondary|Hematologic Laboratory Assessments (Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28|Hematology laboratory assessments (e.g., Neutrophils, Lymphocytes, Eosinophils, and Hematocrit) on Days 3, 7, and 28.|Measured on Day 3, Day, 7 and Day 28|This analysis was based on the Intent to Treat (ITT) population.|||percentage of blood||Standard Deviation|Mean
2610300|NCT02057757|Secondary|Chemistry Laboratory Assessment (CRP) on Days 3, 7, and 28|Lab Values for chemistry laboratory assessment (e.g., CRP) on Days 3, 7, and 28.|Measured on Day 3, Day, 7 and Day 28|This analysis was based on the Intent to Treat (ITT) population.|||mg/L||Standard Deviation|Mean
2610301|NCT02057757|Secondary|Chemistry Laboratory Assessments (ALT, AST, LDH) on Days 3, 7, and 28|Chemistry laboratory assessments (e.g., ALT, AST, and LDH) on Days 3, 7, and 28.|Measured on Day 3, Day 7, and Day 28|This analysis was based on the Intent to Treat (ITT) population.|||U/L||Standard Deviation|Mean
2610302|NCT02057757|Secondary|Chemistry Laboratory Assessments (Creatinine, Total Bilirubin) on Days 3, 7, and 28|Laboratory values for chemistry laboratory assessments (e.g., Creatinine and Total Bilirubin) on Days 3, 7, and 28.|Measured on Day 3, Day, 7 and Day 28|This analysis was based on the Intent to Treat (ITT) population.|||mg/dL||Standard Deviation|Mean
2610303|NCT02057757|Secondary|Number of Participants Reporting Serious Adverse Events (SAEs)|Number of study participants (e.g., adults and children) reporting at least one serious adverse events (SAEs).|Measured through Day 28 or participants' last day of hospitalization|The analysis is based on the safety population.|||Participants|||Count of Participants
2610304|NCT02057757|Secondary|Number of Participants Reporting Adverse Events (AEs)|Number of study participants with at least one Adverse Event During Study Duration|Measured through Day 28 or participants' last day of hospitalization|Analysis was based on the safety population.|||Participants|||Count of Participants
2610305|NCT02057757|Secondary|Presence of Virus on Nasopharyngeal (NP) Swab at Day 3 (Same Virus as Day 0)|Study participants with Detectable Virus on nasopharyngeal (NP) swab at Baseline and at Day 3.|Measured through Day 3|Efficacy analysis of Intent to Treat population|||Participants|||Count of Participants
2610306|NCT02057757|Secondary|Use of Systemic Corticosteroids|Number of study participants taking Systemic Steroids during first 5 days.|Measured within First 5 Days|The analysis was based on the Intent to Treat (ITT) population.|||Participants|||Count of Participants
2610307|NCT02057757|Secondary|Number of Participants Who Are Re-hospitalized Within 28 Days|Number of study participants (e.g., adults and children) who were re-hospitalized within 28 days (e.g., days from randomization).|Measured through Day 28|The Adult (>=18 Years) population includes 126 participants (63 in NTZ arm; 63 in Placebo arm). The Children (<18 Years) population includes 131 participants (67 in NTZ arm; 64 in Placebo arm)|||participants|||Number
2610308|NCT02057757|Secondary|Number of Participants Using Antibiotics/Antivirals During Hospitalization|Number of study participants taking an Antibiotic or Anti-Influenza Antiviral during first 5 days of hospitalization.|Measured through participants' first 5 days of hospitalization||||Participants|||Count of Participants
2610309|NCT02057757|Secondary|Duration (Days) Until Affirmative Global Assessment (e.g., Answered Yes) by Study Participants (e.g., Adults, Children)|Study participant (e.g., adults and children) answers (e.g., yes) to global assessment questions measured daily through Day 14 and then again on Day 28.|Measured daily through Day 14 and on Day 28||||days||Standard Error|Mean
2610310|NCT02057757|Secondary|Number of Study Participants With the Presence of Complications (Pneumonia, Respiratory Failure Requiring Mechanical Ventilation, Acute Respiratory Distress Syndrome [ARDS], Sepsis, or Bronchiolitis) During Study|Number of study participants (e.g., adults and children) with the presence of a complication (pneumonia, respiratory failure requiring mechanical ventilation, acute respiratory distress syndrome [ARDS], sepsis, or bronchiolitis) during the study .|Measured through Day 28 or participants' last day of hospitalization||||Participants|||Count of Participants
2610311|NCT02057757|Secondary|Study Participants (e.g., Adults, Children) Requiring Mechanical Ventilation at Study Time Points (Any Time, Day 0, Day 3, Day 7, Day 14, Day 28)|Study participants (e.g., adults, children) requiring mechanical ventilation (e.g., intubation/extubation) at study time points (Any Time, Day 0, Day 3, Day 7, Day 14, Day 28); worst case imputed.|Measured through Day 28 or participants' last day of hospitalization||||Participants|||Count of Participants
2610312|NCT02057757|Secondary|Number of Study Participants (e.g., Adult and Children) Admitted to the Intensive Care Unit (ICU) by Time Point (Anytime, Day 0, Day 3, Day 7, Day 14, Day 28)|Number of study participants (e.g., adult and children) admitted to the intensive care unit (ICU) by time point (Anytime, Day 0, Day 3, Day 7, Day 14, Day 28); worst case imputed.|Measured through Day 28 or participants' last day in the ICU||||Participants|||Count of Participants
2610314|NCT02057757|Secondary|Duration of Fever in Study Participants|Study participants' duration (hours) of fever measured daily through Day 14 and then again on Day 28. The total duration in hours from the visit when fever was registered for the study participant until the next visit when no fever was registered for the study participant.|Measured each day through Day 14 and on Day 28||||hours||Standard Error|Mean
2610315|NCT02057757|Secondary|Number of Participants Who Experienced Clinical Symptoms|Measured daily through Study Day 14 and then again on Study Day 28|Measured through Day 28||||Participants|||Count of Participants
2610316|NCT02057757|Secondary|Number of Participants Who Died Within the First 5 Days|Total Deaths of Participants, including Deaths within First 5 Days|Measured within First 5 Days|The Adult (>=18 Years) population includes 126 participants (63 in NTZ arm; 63 in Placebo arm). The Children (<18 Years) population includes 131 participants (67 in NTZ arm; 64 in Placebo arm)|||participants|||Number
2610317|NCT02057757|Secondary|Number of Participants Hospitalized on Days 3, 7, 14, and 28|The number of study participants (e.g., adults and children) who were hospitalized on Days 3, 7, 14, and 28.|Measured at Day 3, Day 7, Day 14, and Day 28|Number of study participants - adults (>= 18 years) and children (< 18 years) in the Intent-to-Treat population (ITT) hospitalized by time point|||participants|||Number
2610318|NCT02057757|Primary|Time to Hospital Discharge|The time to hospital discharge measured through Day 28.|Measured through Day 28||||Days||Standard Error|Mean
2610319|NCT02057692|Other Pre-specified|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An AE was any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered related to the investigational drug product. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life -threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.TEAEs were defined as AEs/SAEs that started or worsened after the study drug treatment.|From the start of study drug administration up to Week 17|The Safety Population included all participants who were randomly assigned to study treatment and received at least one dose of the study drug.|||Participants|||Count of Participants
2610320|NCT02057692|Secondary|Change From Baseline to Endpoint (Week 13/Early Termination) in Total and Direct Bilirubin Concentrations|Liver enzyme levels of total bilirubin and direct bilirubin were reported here.|Baseline, Week 13/Early Termination|mITT population included all participants randomly assigned to study treatment, receiving at least 1 dose of treatment, and having at least 1 post baseline observer itch reported outcome (ItchRO[Obs]) average daily score.|||Milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2610321|NCT02057692|Secondary|Change From Baseline to Endpoint (Week 13/Early Termination) in Liver Enzyme Levels|Liver enzyme levels of alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase and gamma glutamyl transferase were reported here.|Baseline, Week 13/Early Termination|mITT population included all participants randomly assigned to study treatment, receiving at least 1 dose of treatment, and having at least 1 post baseline observer itch reported outcome (ItchRO[Obs]) average daily score.|||Unit per liter (U/L)||Standard Error|Least Squares Mean
2610322|NCT02057692|Secondary|Change From Baseline to Endpoint (Week 13/Early Termination) in Fasting Serum Bile Acid (sBA) Level|Fasting sBA level was measured by using a liquid chromatography mass spectrometry method.|Baseline, Week 13/Early Termination|mITT population included all participants randomly assigned to study treatment, receiving at least 1 dose of treatment, and having at least 1 post baseline observer itch reported outcome (ItchRO[Obs]) average daily score.|||Micro moles per liter (mcmol/L)||Standard Error|Least Squares Mean
2610323|NCT02057692|Primary|Change From Baseline to Endpoint (Week 13/Early Termination) in Pruritus|Pruritus was assessed using Itch report outcome measure (ItchRO[Obs]), administered as an electronic diary (eDiary) which was completed by the participants twice daily (morning and evening). ItchRO(Obs) score ranged from 0 to 4, with the higher score indicating increasing itch severity. The highest score between the morning and evening ItchRO(Obs) reports represented the daily score: a measure of the worst itching over the previous 24-hour period.|Baseline, Week 13/Early Termination|Modified Intent-to-Treat Population (mITT) population included all participants randomly assigned to study treatment, receiving at least 1 dose of treatment, and having at least 1 post baseline observer itch reported outcome (ItchRO[Obs]) average daily score.|||Score on a scale||Standard Error|Least Squares Mean
2610324|NCT02057640|Secondary|Overall Survival|Overall survival for all will be the number of months from study entry to death from any cause.|up to 3 years from start of treatment||||months||95% Confidence Interval|Median
2610325|NCT02057640|Secondary|Progression-free Survival|"Progression-free survival will be the number of days from study entry to progression or death of any cause, whichever comes first.~Progression-free survival is survival with absence of progressive disease, defined by~An increase of 25% from lowest response value in any one or more of the following:~Serum M-component (absolute increase must be >0.5 g/100 ml) *~Urine M-component (absolute increase must be >200mg per 24 h)~Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be >100 mg/l)~Bone marrow plasma cell percentage (absolute % must be >10%)~And / or:~Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas~Development of hypercalcemia (corrected serum calcium >11.5 mg/100 ml) that can be attributed solely to the plasma cell proliferative disorder"|1 year from start of treatment||||months||95% Confidence Interval|Median
2610326|NCT02057640|Secondary|Response to Combination Therapy (Panobinostat, Dexamethasone, MLN9708)|Response to intervention as measured by international uniform response criteria and clinical benefit response according to modified EBMT response criteria, comparing myeloma panels obtained at the beginning of each cycle that include SPEP, 24 h UPEP, serum and urine IFEs, and serum free light chains to results at screening. In addition a baseline bone marrow exam and skeletal survey will be obtained and repeated as clinically indicated and for assessment of complete remission (bone marrow)|4 months (102 days)||||participants|||Number
2610327|NCT02057640|Primary|Number of Participants With Dose Limiting Toxicity According to CTCAE Version 4.03|Number of Participants with Dose Limiting Toxicity of MLN9708 (lxazomib) according to CTCAE version 4.03|at 28 days from start of treatment|All participants who received treatment in the phase I portion of the study|||Participants|||Count of Participants
2610334|NCT02057549|Secondary|Emergency Department Length of Stay (EDLOS)|"The time frame starts from the moment of receiving the study drug to the time when the decision for final disposition is made. Usually after symptoms are controlled, patients are given a PO challenge (food or drink) in order to establish if they are OK to go home. If symptoms return, additional medications are given, the treatment is consider failed and they are admitted to the Hospital.~Patients will not be followed up if admitted to any service. The study ends when final disposition is made.~Patients follow up after final disposition is not part of the study and will not be done."|at the time the decision for final disposition is made (about 8 hours)||||hours||Inter-Quartile Range|Median
2610335|NCT02057549|Secondary|Number of Participants Admitted to the Hospital After Emergency Department Visit||2 hours after study medication given||||Participants|||Count of Participants
2610336|NCT02057549|Primary|Pain Relief as Indicated by Number of Participants Not Requesting Additional Pain Medication||1 hour after study medication given||||Participants|||Count of Participants
2610337|NCT02057458|Primary|RER Peak|peak respiratory exchange ratio during maximal exercise test|pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment||||ratio||Standard Deviation|Mean
2610338|NCT02057458|Primary|VE Peak|peak ventilation (L/min) during maximal exercise test|pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment||||L/min||Standard Deviation|Mean
2610339|NCT02057458|Primary|VO2 Peak (Percent Predicted)|Maximal Oxygen consumption expressed as percent predicted taken from maximal exercise test.|pre-treatment Baseline and 1 hour post-treatment, and 4 weeks sub-chronic treatment||||percent predicted||Standard Deviation|Mean
2610340|NCT02057458|Primary|VO2 Peak (Relative)|relative (mL/kg/min) peak oxygen consumption during maximal exercise test|pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment||||mL/kg/min||Standard Deviation|Mean
2610341|NCT02057458|Primary|VO2 Peak (Absolute)|absolute (L/min) peak oxygen consumption during maximal exercise test|pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment||||L/min||Standard Deviation|Mean
2610342|NCT02057458|Primary|FEV1 (% Predicted)|Forced Expiratory Volume in the first second expressed as a percent predicted.|pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment||||percent predicted||Standard Deviation|Mean
2610343|NCT02057458|Primary|Absolute Change in Diameter|Absolute change in brachial artery diameter taken from the FMD assessment|pre-treatment Baseline and following 4 weeks sub-chronic treatment||||mm||Standard Deviation|Mean
2610344|NCT02057458|Primary|Peak Diameter|Peak Brachial Artery Diameter during FMD (post-occlusion)|pre-treatment Baseline and following 4 weeks sub-chronic treatment||||mm||Standard Deviation|Mean
2610345|NCT02057458|Primary|Baseline Diameter|"Brachial Artery Diameter during FMD (pre-occlusion or baseline)"|pre-treatment Baseline and following 4 weeks sub-chronic treatment||||mm||Standard Deviation|Mean
2610346|NCT02057458|Primary|Acute Study: Percentage Flow-Mediated Dilation (FMD)|FMD determined one hour after ingestion of 50 mg Sildenafil or placebo|pre-treatment Baseline and 1 hour post-treatment||||percent flow mediated dilation||Standard Deviation|Mean
2610347|NCT02057406|Primary|Endpoint Red Blood Cell/Plasma EPA Values Adjusted for Age, Sex, Treatment Site, and Baseline Red Blood Cell/Plasma EPA Values.|Endpoint EPA values are mean values adjusted for age, race, sex, treatment site, and the baseline EPA value. Red blood cell/plasma EPA values are expressed as a percent of total identified fatty acids.|Week 12|"The numbers at baseline reflect the total number of patients who provided samples for the assay of omega 3 percentage of total fatty acids.~The numbers at endpoint reflect the total number of patients included in the intention to treat analysis."|||percentage of total fatty acids||Standard Error|Mean
2610348|NCT02057406|Primary|Endpoint Hamilton Depression Rating Scale (HAMD) Scores Adjusted for Age, Sex, Treatment Site, and Baseline HAMD Scores.|Endpoint HAMD scores are mean values adjusted for age, race, sex, treatment site, and the baseline HAMD value. The range for the HAMD scores is 0 to 52 with higher scores indicating a greater severity of depressive symptoms.|Week 12||||units on a scale||Standard Error|Mean
2610349|NCT02057393|Primary|Equivalence of ICG and Real Time Lymphangiography to technetium99 and Blue Dye in Localizing Sentinel Nodes|The primary outcome measure is the accuracy of indocyanine green (ICG) and real time lymphangiography to identify sentinel nodes (SLN) in patients with melanoma, compared to tech99 and methylene blue. Tech99 is considered the standard, for comparison. Accuracy is being determined by the number of sentinel nodes that are identified with ICG, compared to tech99 or methylene blue.|2 weeks||||number of sentinel nodes per patient||Standard Deviation|Mean
2610350|NCT02057276|Other Pre-specified|"Change in the Melbourne Assessment of Unilateral Upper Limb Function"||"Change in the Melbourne Assessment of Unilateral Upper Limb Function between baseline and 12 weeks after rTMS/OT"|After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.||||||
2610351|NCT02057276|Other Pre-specified|"Change in the Melbourne Assessment of Unilateral Upper Limb Function"||"Change in the Melbourne Assessment of Unilateral Upper Limb Function between baseline and 7 days after rTMS/OT"|After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.||||||
2610352|NCT02057276|Primary|"Change in the Melbourne Assessment of Unilateral Upper Limb Function"||"Change in the Melbourne Assessment of Unilateral Upper Limb Function between baseline and 3 days after rTMS/OT"|After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.||||||
2610353|NCT02057250|Secondary|Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab|AUC(0-tau) is defined as area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval, where dose interval was 2 weeks. Serum concentrations of sarilumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).|Week 0-2: pre-dose on Day 1, anytime post-dose on Day 3, Day 5, Day 8, Day 12, Day 15; Week 10-12: pre-dose on Day 71, anytime post-dose on Day 73, Day 75, Day 78, Day 82, Day 85|Pharmacokinetic(PK) population included all randomized participants who received at least 1 dose of IMP and have least 1 PK parameter calculated using non compartmental methods following the first (Day 1) or sixth administration (Day 71). Here, Number Analyzed = participants with available data for specified category for each arm, respectively.|||mg*day/L||Standard Deviation|Mean
2610354|NCT02057250|Primary|Number of Validated AID Associated Product Technical Failures (PTFs)|"A PTF was defined as any product technical complaint (PTC) related to the use of the AID that had a validated technical cause. Each participant was given a diary having questions related to participant's ability to remove the cap, to start the injection, to complete the injection and regarding confirmation of completing the injection. Participants were asked to answer the questions each time they self-inject the sarilumab. If the response was no to any of the first 3 questions, this was considered as a PTC. The used AID, for which PTC was reported, was sent to sponsor, examined and evaluated for the occurrence of a PTF."|Baseline up to Week 12|Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of investigational medicinal product (IMP) with AID and attended at least 1 post-baseline visit during AID assessment phase of the study.|||PTFs|Injections||Number
2610355|NCT02057237|Secondary|Prostate Specific Antigen (PSA) Response Rate|"Continue increase of serum PSA beyond 8 weeks indicate PSA progression. Response and progression will be primarily evaluated in this study using PSA response criteria from the Prostate Cancer Working Group 2. Criteria used to define response include: at least a 50% decline in PSA, confirmed by a second measurement ≥4 weeks later. PSA progression is defined by a >25% increase from baseline in patients whose PSA did not decrease, and of 50% from the nadir value in patients whose PSA decreased. This increase in PSA must be >5 ng/ml, and confirmed by a second measurement, at least 1 week later; PSA nadir is defined as the minimum PSA value that was confirmed by a second measurement.~PSA progression free survival is defined as the time between the randomization date and the date of PSA progression or the date of death due to prostate cancer, whichever occurs first."|PSA progression free survival and excessive toxicity. Plan to keep the patients on Mitotane for atleast 8 weeks, despite increasing level of PSA as other trials shown early increase in PSA followed by a subsequent decline.|||||||
2610356|NCT02057237|Primary|The Primary Endpoint is the Proportion of Patients Maintained on Mitotane After 12 Consecutive Weeks of Therapy. A Positive Outcome Would be Seeing 50% or More Patients Maintained on Therapy. Secondary Endpoint Include Proportion of Adverse Events||maintain 50% of the patients on Mitotane at the 12 week mark|As only 1 patient was accrued to this trial, no data analysis was performed.||||||
2610357|NCT02057198|Secondary|Percentage of Stool Specimens From Patients That Are Positive for C. Difficile|Percentage of stool cultures positive for C. difficile at each time point|Days 0, 3, 7, 14|Only completed participants were included in the analysis.|||% of positive stool cultures|specimens||Number
2610358|NCT02057198|Secondary|Count of Stool Specimens From Patients That Are Positive for C. Difficile|Count of stool cultures positive for C. difficile at each time point|Days 0, 3, 7, 14|Only completed participants were included in the analysis.|||Number of positive stool cultures|specimens||Number
2610359|NCT02057198|Secondary|C. Difficile Shedding in Stool Over Time|C. difficile was isolated and serially diluted to permit colony counts (CFU/g stool) over time for each patient.|Days 0, 3, 7, 14|Only completed participants were included in the analysis.|||CFU/g stool||Standard Deviation|Mean
2610360|NCT02057198|Secondary|Molecular Relatedness of Isolates|When sufficient growth was available to permit sub-culture and ribotyping, we conducted ribotyping of each patient's stool C. difficile isolate for comparison to isolates from the same patient's hospital environment. Reported is the total percent of hospital room environmental isolates that match the ribotyping of the associated patient's stool sample (there is no averaging).|Days 0-14|Ribotyping could only be conducted in instances where sufficient growth occurred from both patient and environmental samples to permit subculture.|||percent of matching isolates|Environmental Isolates||Number
2610361|NCT02057198|Secondary|Total Environmental Contamination According to Antibiotic Treatment Group|In addition to total colony counts over time, the investigators also assessed the proportion of positive cultures over time (from the 5 replicate Rodac plate samplings repeated at each of 5 sites within each patient room: bedrail, overbed table, sink, toilet seat and bathroom floor). The cumulative proportion of positive cultures (including days 0, 3, 7, 14) is reported according to each treatment group.|Days 0, 3, 7, and 14|Only completed participants were included in the analysis.|||percentage of positive cultures|Environmental cultures||Number
2610362|NCT02057198|Primary|Change in Total Median Total Colony Forming Units (CFU) of C. Difficile Identified in the Hospital Room Environment for Each Antibiotic Treatment Group.|Rodac plates were used to take environmental samples from 5 different sites within each patient's hospital room (bedrail, overbed table, sink, toilet seat, bathroom floor). Each Rodac plate samples a surface area of ~25 cm2. 5 replicates were taken for each site and repeated on days 0, 3, 7, and 14. Median total colony counts are reported for each treatment group. Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.|Days 0, 3, 7 and 14.|Only completed participants were included in the analysis.|||Colony forming units (CFUs)||Inter-Quartile Range|Median
2610363|NCT02057068|Secondary|BEF-SHI Total Number of Negative Sleep Hygiene Behaviors|Total Number of negative sleep hygiene indicators from the BEFSHI - Bedtime Environmental Features and Sleep Hygiene Index (e.g., nighttime caffeine, nighttime snacking-sugar, nicotine, excessive alcohol, excessive daytime napping, television, tablet and computer use in bedroom after 9 pm etc.) Participants are asked to respond yes (1) or no (0) to a series of sleep hygiene behaviors considered detrimental to sleep. Scores are summed. Possible scores range from 0-8 with a greater score indicating a greater number of negative sleep hygiene behaviors endorsed.|Baseline (T1) and Post-Intervention (T2) - 8 Weeks||||units on a scale||Standard Deviation|Mean
2610364|NCT02057068|Secondary|Mean Sleep Efficiency|Average sleep efficiency over 7 nights of actigraphic measurement . Sleep efficiency is calculated as the number of hours asleep divided by the number of hours in bed with the intention to sleep.|Baseline (T1) and Post-Intervention (T2) - 8 Weeks||||percentage of sleep/time in bed||Standard Deviation|Mean
2610365|NCT02057068|Primary|Subjective Sleep Quality|Pittsburgh Sleep Quality Index Scores (PSQI) The Pittsburgh Sleep Quality Index is a standardized and validated measure of subjective sleep quality and sleep disturbance. The inventory has 18-items. PSQI scores range from 0 - 21. A total score > 5 (some evidence for 8) is indicative of poor sleep quality.|Baseline (T1) and Post-Intervention (T2) - 8 Weeks||||units on a scale||Standard Deviation|Mean
2610405|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 12 hours (msec)|12 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
2610366|NCT02057042|Secondary|Anxiety|"Generalized Anxiety will be measured with the Generalized Anxiety Disorder 7-item (GAD-7). Total score ranges from 0 to 21, with cut scores for mild, moderate and severe anxiety. Although originally developed for generalized anxiety disorder symptoms, the GAD-7 has good operating characteristics for detection and severity ratings of panic disorder and social anxiety disorder. Scores are summed with a range of 0-21. Scores represent: 0-5 mild, 6-10 moderate, 11-15 moderate/severe, and 15-21 severe anxiety."|change over time (baseline, 3 months, 6 months)|Numbers analyzed in each time period account for attrition in follow-up|||score on a scale||Standard Deviation|Mean
2610367|NCT02057042|Secondary|Cognitive Behavioral Therapy Skills|CBT skills will be assessed using the Cognitive-Behavioral Therapy Skills Questionnaire (CBTSQ). The CBTSQ is a 16-item scale consisting of two factors, Behavioral Activation and Cognitive Restructuring. The scale shows construct validity, appears sensitive to change among patients undergoing CBT treatment, and predicts reduction in depressive symptoms. Scores are summed with a maximum score of 80. Higher scores indicate greater uptake of CBT skills.|change over time (baseline, 3 months, 6 months)|Numbers analyzed in each time period account for attrition in follow-up|||score on a scale||Standard Deviation|Mean
2610368|NCT02057042|Primary|Quality of Life Enjoyment and Satisfaction|The Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) is a valid proxy for the longer Quality of Life Enjoyment and Satisfaction (Q-LES) form and will be used to assess quality of life. It consists of 14 items that patients rate on a 5-point scale to indicate their satisfaction with a variety of life domains, including physical health, mood, work, household activities, social relationships, etc. The Q-LES-Q-SF has been shown to have high levels of reliability and has been used in numerous studies of depression, including the National Institute of Mental Health (NIMH) funded STAR*D study. Responses are scored on a 5-point scale, where higher scores indicate better enjoyment and satisfaction with life (possible range 14-70).|change over time (baseline, 3 months, 6 months)|Numbers analyzed in each time period account for attrition in follow-up|||score on a scale||Standard Deviation|Mean
2610369|NCT02057042|Primary|Recovery Orientation|Recovery orientation will be measured using the Recovery Assessment Scale - Short Form (RAS-SF). This 20-item scale is a shorter version of the RAS and has four factors: personal confidence and hope, willingness to ask for help, reliance on others, and no domination by symptoms. The RAS-SF shows evidence for both convergent and discriminate validity when compared to quality of life, social support, and symptomatic scales. The scale is scored by summing all items (or scale items), with 100 being the highest possible overall score. Higher scores indicate greater sense of recovery.|change over time (baseline, 3 months, 6 months)|Numbers analyzed in each time period account for attrition in follow-up|||score on a scale||Standard Deviation|Mean
2610370|NCT02057042|Primary|Depression Symptoms|Inventory of Depressive Symptoms (IDS) at baseline, 3 months post intervention and 6 months post intervention. The ISD is a 16-item self-report instrument for measuring the severity of depression among individuals. Each item is rated on a four-point scale (0-3), and aggregate scores range from 0 to 27. The IDS has been widely used and shows acceptable reliability, with Cronbach's of 0.86. Severity of depression is scored according to the following ranges: 1-5 (no depression), 6-10 (mild), 11-15 (moderate), 16-20 (severe), and 21-27 (very severe).|change over time (baseline, 3 months, 6 months)|Numbers analyzed in each time period account for attrition in follow-up|||score on a scale||Standard Deviation|Mean
2610371|NCT02057042|Primary|Functional Status|Functional status will be measured using the Veterans RAND 12-Item Health Survey (VR-12). Developed from VR-36, VR-12 includes 12 original question items from the VR-36. The questions in this survey correspond to seven different health domains inlcuding general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into a Physical Component Score (PCS) and a Mental Component Score (MCS) which allows for a comparison between the respondents physical and psychological health status.The VR-12 has somewhat greater precision at the lower end of the health status continuum than the SF-12. The VR-12 has been used in numerous prior VA focused studies. VR-12 MCS component scores are standardized to a mean of 50, with higher scores indicating better mental health and related functioning.|change over time (baseline, 3 months, 6 months)|Numbers analyzed in each time period account for attrition in follow-up|||score on a scale||Standard Deviation|Mean
2610372|NCT02056834|Primary|Mean Time to Union|Mean time to union was calculated based on the Kaplan-Meier estimator of the survivorship function|12 months||||months||Standard Deviation|Mean
2610373|NCT02056834|Secondary|Lysholm Knee Scale|The Lysholm knee scale is a condition-specific outcome measure that was originally designed to assess ligament injuries of the knee. The survey was administered to subject at follow-up visits and comprises 8 subscales related to limp, support, stair climbing, squatting, walking, running and jumping as well as a question related to the atrophy of the thigh. The responses to these 8 questions are graded to provide a maximum result of 100 points.|12 months||||participants|||Number
2610374|NCT02056834|Secondary|VAS Leg Pain Frequency|The subjects completed questionnaires assessing the intensity and frequency of pain experienced in the leg at the baseline visit and postoperatively. Pain frequency was rated on a 100-mm visual analog scale where zero indicated no pain at all and 100 represented pain always.|12 months||||units on a scale||Standard Deviation|Mean
2610375|NCT02056834|Secondary|VAS Leg Pain Intensity|The subjects completed questionnaires assessing the intensity and frequency of pain experienced in the leg at the baseline visit and postoperatively. Pain intensity was rated on a 100-mm visual analog scale where zero indicated no pain at all, and 100 represented the worst possible pain.|12 months||||units on a scale||Standard Deviation|Mean
2610376|NCT02056834|Secondary|SF-12 Short Form Health Survey Mental Composite Score (MCS)|The SF-12 short form health survey was self-administered to subjects preoperatively and at follow up visits. This health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.|12 months||||units on a scale||Standard Deviation|Mean
2614833|NCT02006758|Secondary|Mean Change in Office Systolic Blood Pressure at 12 Months||Baseline and 12 months|54 out of 67 participants analyzed for mean change in office Systolic Blood Pressure at 12 months.|||mmHg||Standard Deviation|Mean
2610377|NCT02056834|Secondary|SF-12 Short Form Health Survey Physical Composite Score (PCS)|The SF-12 short form health survey was self-administered to subjects preoperatively and all follow up visits. This health survey comprises 12 questions related to health and wellbeing over the prior four weeks. The responses to these 12 questions are entered into a standardized algorithm to provide summaries of physical and mental health (i.e., physical composite score [PCS] and mental composite score [MCS]). The summary scores are standardized and normalized such that a score of 50 for either the PCS or MCS corresponds to that of an average, healthy person. A score lower than 50 indicates poorer physical and mental health compared to an average, healthy person.|12 months||||units on a scale||Standard Deviation|Mean
2610378|NCT02056834|Secondary|Peri-operative Complications||12 months||||participants|||Number
2610379|NCT02056834|Secondary|Extension Ability and Stability|"The following was assessed:~extension ability of the knee~stability of the knee in extension"|12 months||||participants|||Number
2610380|NCT02056834|Secondary|Surgeon's Satisfaction With the Product|Satisfaction with product was assessed by the surgeon post-operatively, where surgeons indicated their satisfaction with treatment on a 100-mm visual analog scale. A score of zero indicated absolutely unacceptable, while a score of 100 indicated very satisfying.|Post-surgery||||units on a scale||Standard Deviation|Mean
2610381|NCT02056834|Secondary|Patient's Satisfaction|Satisfaction with treatment was assessed by the subjects, where subjects indicated their satisfaction with treatment on a 100-mm visual analog scale. A score of zero indicated no satisfaction, while a score of 100 indicated completely satisfied.|12 months||||units on a scale||Standard Deviation|Mean
2610382|NCT02056834|Secondary|Anatomical Gradings Assessed Radiographically|"The following was assessed:~depression of knee joint: presence or absence~condylar widening (enlargement of the knee joint): presence or absence~angulation; valgus/varus (abnormal outward/inward turning of the knee): presence or absence"|12 months||||participants|||Number
2610383|NCT02056834|Secondary|Total Range of Motion||12 months||||participants|||Number
2610384|NCT02056834|Secondary|Patients Who Reached Full Weight Bearing||12 months||||participants|||Number
2610385|NCT02056834|Secondary|Absorption Rate of Calcium Phosphate Cement|Absorption of calcium phosphate cement over time was calculated from X-rays with the INFINITT program.|12 months||||percentage of absorption at 12 months||Standard Deviation|Mean
2610386|NCT02056834|Primary|Articular Subsidence|Evidence of articular subsidence (collapse of surface pertaining to the joint) of ≥2 mm was assessed by the investigators|12 months||||participants|||Number
2610387|NCT02056834|Primary|Fracture Union|Fracture union (complete bone healing) was assessed by the investigators based on anteroposterior and lateral X-rays|12 months||||participants|||Number
2610388|NCT02056652|Secondary|Number of Subjects Experiencing Chorioamnionitis|The AE of Chorioamnionitis was captured for each group.|Time of delivery||||Participants|||Count of Participants
2610389|NCT02056652|Secondary|Number of Subjects Experiencing Neonatal Death|Number of participants who experienced neonatal deaths from birth to day 28 was captured for each group.|Between birth and 28 days of age||||Participants|||Count of Participants
2610390|NCT02056652|Secondary|Number of Participants Experiencing Spontaneous Rupture of Membranes|Rupture of membranes before 34 weeks gestation was captured in each group.|Less than 34 weeks gestation||||Participants|||Count of Participants
2610391|NCT02056652|Secondary|Number of Participants That Experienced Spontaneous Preterm Births on Trial|The number of spontaneous births that occurred in participants on trial before 37 weeks was captured.|Before 37 weeks gestation||||Participants|||Count of Participants
2610392|NCT02056652|Secondary|Average Birth Weight of Babies Born on Trial|The birth weights of babies born in the pessary group was compared to those born in the no pessary group|Time of delivery||||grams||Full Range|Mean
2610393|NCT02056652|Primary|Number of Subjects Experiencing Preterm Birth|Birth before 37 weeks gestation was captured.|Before 37 weeks gestation (20 0/7 - 36 6/7 weeks)||||Participants|||Count of Participants
2610394|NCT02056639|Secondary|Number of Subjects Experiencing Chorioamnionitis|Chorioamnionitis was recorded and analyzed for participants in each group.|Time of delivery||||Participants|||Count of Participants
2610395|NCT02056639|Secondary|Number of Participants That Experienced Neonatal Death|Number of participants that experienced neonatal deaths that occurred in each group following birth was recorded and analyzed.|Between birth and 28 days of age||||Participants|||Count of Participants
2610396|NCT02056639|Secondary|Spontaneous Preterm Birth Rates||Less than 37 weeks gestation||||Participants|||Count of Participants
2610397|NCT02056639|Secondary|Average Birth Weight of Babies in Each Group|The birth weight of babies is the pessary group and no pessary group were recorded and analyzed for comparison.|Time of delivery||||grams||Full Range|Mean
2610398|NCT02056639|Primary|Number of Participants With Preterm Delivery||Less than 34 weeks gestation||||Participants|||Count of Participants
2610399|NCT02056626|Primary|Mean Systolic Blood Pressure||day 30||||mmHg||Standard Deviation|Mean
2610400|NCT02056626|Primary|Mean Systolic Blood Pressure||day 14||||mmHg||Standard Deviation|Mean
2610401|NCT02056626|Primary|Mean Systolic Blood Pressure||day 0||||mmHg||Standard Deviation|Mean
2610402|NCT02056431|Secondary|Number of Participants With Minimally Effective Dose in 12 Months|Count of patients who ever received a minimally effective dose of the medications they started on during the 12 months following treatment start (measured post only).|12 months|1179 Patient completed the close out survey|||Participants|||Count of Participants
2610403|NCT02056431|Primary|Change in Patient Quality of Life at Baseline and 8 Months|"The primary outcome measure is change in quality of life from baseline at eight months following study entry. We calculated the EuroQOL (EQ-5D) from the Global Health Scale, a 10-item Patient-Reported Outcomes Measurement Information System measure developed and validated in patients with neuropathy as part of the Quality of Life in Neurological Disorders Measures. The range for EQ-5D is 0-1, with 0 being the worst and 1 being the best."|Baseline and 8 months|1179 patients completed the close out survey|||units on a scale||Standard Deviation|Mean
2610404|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 24 hours (msec)|24 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
2610406|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 8 hours (msec)|8 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
2610407|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 6 hours (msec)|6 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
2610408|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 4 hours (msec)|4 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
2610409|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 3 hours (msec)|3 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
2610410|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 2 hours (msec)|2 hours|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
2610411|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 1 hour 30 min (msec)|1 hour 30 min|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
2610412|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 1 hour (msec)|1 hour|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
2610413|NCT02056392|Primary|Change From Baseline in QTcF|Change from baseline in QTcF at 30 minutes (msec)|30 min|All patients who had evaluable pharmacodynamic data available for at least one treatment group were included in the PD analysis set|||msec|Participants|95% Confidence Interval|Least Squares Mean
2610414|NCT02056340|Other Pre-specified|ICU and Hospital Length of Stay|The investigators will assess the effect of statin therapy on hospital and ICU length of stay.|From date of randomization until the date of ICU discharge (in the event of ICU admission) and/or hospital discharge, based on an estimated average of 30 days|||||||
2610415|NCT02056340|Other Pre-specified|In-hospital Mortality|The investigators will assess the effect of statin therapy on in-hospital mortality|From date of randomization until the date of first documented discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 year|||||||
2610416|NCT02056340|Other Pre-specified|Severity of Illness|The investigators will assess the effect of statin therapy on APACHE II scores|24 hours post enrollment|||||||
2610417|NCT02056340|Other Pre-specified|Progression to Shock State|The investigators will assess the effect of statin therapy on rates of development of shock state|From date of randomization until discharge from hospital|||||||
2610418|NCT02056340|Secondary|Severity of Illness Score Baseline to 72 Hours|Composite score for 5 major symptoms (fever, cough, sore throat, headache, myalgia) ranked from 0 to 3 (none, mild, moderate, severe) for a score ranging from 0 to 15. Higher scores reflect more severe symptoms.|Baseline and 72 hours||||score on a scale||Inter-Quartile Range|Median
2610419|NCT02056340|Primary|Change in Inflammatory Markers From Time Zero to 72 Hours|The primary IL- 6 measurements were at time zero and at 72 hours. Analysis was performed using a linear mixed effects model to make use of all biomarker timepoints as hospitalized patients had biomarkers measured at additional timepoints.|Baseline to 72 hours||||pg/ml||Inter-Quartile Range|Median
2610420|NCT02056171|Other Pre-specified|Change in Delirium Severity|Participants were screened for delirium daily using the Cornell Assessment for Pediatric Delirium, which assigns a delirium score between 0 (no delirium) to 32 (severe delirium). This describes the change in delirium score between study drug initiation (either quetiapine or placebo) and 72 hours. A decrease in score implies an improvement in delirium severity. For the quetiapine group, there was a median decrease in scale score (for the 3 subjects) of 1; for the placebo group, there was no change in delirium screen scores.|Baseline and 3 days of study drug initiation|Change in CAPD score from baseline to day 3. A decrease in total score implies an improvement in delirium. An increase in total score implies worsening delirium.|||units on a scale||Full Range|Median
2610421|NCT02056171|Secondary|Total ICU Days With Delirium|Participants were screened for delirium daily. This describes the number of days with delirium within the 10 day study period.|Within 10 days after study enrollment||||days||Full Range|Mean
2610422|NCT02056171|Primary|Time to First Resolution of Delirium|Participants were screened for delirium daily. This describes the number of days from study drug initiation (either quetiapine or placebo) to first resolution of delirium (defined as a score of less than 9 on teh Cornell Assessment of Pediatric Delirium [CAPD]). If delirium did not resolve within the 10 day period, this defaults to 10 days.|Within the first 10 days after study enrollment|All participants are included in analysis.|||days||Full Range|Mean
2610423|NCT02055976|Secondary|Plasma Concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)|Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLQ =6.99 nanogram per milliliter [ng/mL]) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0. Here, 'Number analyzed' = Participants evaluable for this outcome measure at specified time points.|Day 1, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141|PK concentration population included participants in FAS who have at least 1 concentration of either PF-04950615, PCSK9 or atorvastatin or its active metabolites. This outcome measure was planned to be analyzed for all the reporting groups except for Atorvastatin + Ezetimibe 10 mg.|||ng/mL||Standard Deviation|Mean
2610424|NCT02055976|Secondary|Terminal Elimination Half-Life (t1/2) of PF-04950615|Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.|Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)|The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, N signifies participants evaluable for this outcome measure.|||day||Standard Deviation|Mean
2610425|NCT02055976|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615|This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.|Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hour (hr) post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)|The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||day||Full Range|Median
2610426|NCT02055976|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-04950615|This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.|Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)|The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, N signifies participants evaluable for this outcome measure.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2610427|NCT02055976|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-04950615|This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.|Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hr post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)|The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||microgram per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2610428|NCT02055976|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615|Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.|Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)|The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, N signifies participants evaluable for this outcome measure.|||mcg*day/mL||Geometric Coefficient of Variation|Geometric Mean
2610429|NCT02055976|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-04950615|Area under the plasma concentration-time profile from time zero extrapolated to infinite time. This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.|Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)|The PK parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|||mcg*day/mL||Geometric Coefficient of Variation|Geometric Mean
2610430|NCT02055976|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615|Area under the plasma concentration time-curve from time zero to end of dosing interval (tau). This outcome measure was to be analyzed in participants who received at least 1 dose of the PF-04950615.|Single dose (Day 1: pre-dose, 24, 48, 72, 96, 120, 144, 168 hour (hr) post-dose), Multiple dose (Day 99: pre-dose, 24, 72, 120, 168, 336, 504, 672, 1008 hr post-dose)|The pharmacokinetic (PK) parameter analysis population included participants with full PK sampling in FAS who had at least 1 of the PF-04950615 PK parameters of interest. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||microgram*day per milliliter(mcg*day/mL)||Geometric Coefficient of Variation|Geometric Mean
2610431|NCT02055976|Secondary|Number of Participants With Anti-Drug Antibody (ADA) Response|Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=6.23 for PF-04950615 were considered ADA positive.|Baseline up to Day 169|Safety analysis set included all randomized and non-randomized participants who were administered at least 1 dose of study treatment. This outcome measure was planned to be analyzed for all the reporting groups except for Atorvastatin + Ezetimibe 10 mg.|||participants|||Number
2610432|NCT02055976|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 169 that were absent before treatment or that worsened relative to pretreatment state. Adverse events included treatment emergent injection site adverse events and any clinically significant abnormal laboratory value.|Baseline up to Day 169|Safety analysis set included all randomized and non-randomized participants who were administered at least 1 dose of study treatment.|||participants|||Number
2610433|NCT02055976|Secondary|Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 10, 25, 40, 70 and 100 Milligram Per Deciliter|LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection.|Baseline up to Day 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. The outcome measure was planned to be analyzed for all the reporting groups except Atorvastatin + Ezetimibe 10 mg.|||percentage of participants|||Number
2610434|NCT02055976|Secondary|Percent Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113|Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||percent change||Standard Deviation|Mean
2614834|NCT02006758|Secondary|Renovascular Safety at 6 Months (Renal Artery Stenosis)|Assessment of renovascular safety as measured by new renal artery stenosis or aneurysm at the site of ablation.|6 months||||Participants|||Count of Participants
2610435|NCT02055976|Secondary|Change From Baseline in Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio at Day 85 and Day 113|Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||ratio||Standard Deviation|Mean
2610436|NCT02055976|Secondary|Apolipoprotein B (ApoB) / Apolipoprotein A-I (ApoA-I) Ratio|Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.|Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||ratio||Standard Deviation|Mean
2610437|NCT02055976|Secondary|Percent Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113|Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||percent change||Standard Deviation|Mean
2610438|NCT02055976|Secondary|Change From Baseline in Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio at Day 85 and Day 113|Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||ratio||Standard Deviation|Mean
2610439|NCT02055976|Secondary|Total Cholesterol (TC) / High Density Lipoprotein- Cholesterol (HDL-C) Ratio|Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.|Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||ratio||Standard Deviation|Mean
2610440|NCT02055976|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113|Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||percent change||Standard Deviation|Mean
2610441|NCT02055976|Secondary|Change From Baseline in Non-High Density Lipoprotein- Cholesterol (Non-HDL-C) at Day 85 and Day 113|Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610442|NCT02055976|Secondary|Non-High Density Lipoprotein- Cholesterol (Non-HDL-C)|Non-HDL-C calculated as total cholesterol minus HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.|Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610496|NCT02055430|Primary|Complications of Each Drainage Method|"complications of initial urinary drainage using percutaneous nephrostomy or ureteric stent in children with Obstructive Anuria and Acute Renal Failure (mucosal complications, failure of insertion, slippage, fever and infection, hematuria, leakage)~complications were calculated per 45 ureterorenal units in PCN group and 90 ureterorenal units in Double J group"|1 week|||||||
2610443|NCT02055976|Secondary|Percent Change From Baseline in Triglyceride (TG) at Day 85 and Day 113|Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||percent change||Standard Deviation|Mean
2610444|NCT02055976|Secondary|Change From Baseline in Triglyceride (TG) at Day 85 and Day 113|Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610445|NCT02055976|Secondary|Triglyceride (TG)|Triglycerides are a type of fat circulating in the blood and account for the majority of the fats circulating in the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.|Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610446|NCT02055976|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113|VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||percent change||Standard Deviation|Mean
2610447|NCT02055976|Secondary|Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Day 85 and Day 113|VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610448|NCT02055976|Secondary|Very Low Density Lipoprotein-Cholesterol (VLDL-C)|VLDL is a type of lipoprotein made by the liver and one of the five major groups of lipoproteins, that enable fats and cholesterol to move within the water-based solution of the bloodstream. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.|Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610449|NCT02055976|Secondary|Percent Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113|HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||percent change||Standard Deviation|Mean
2610484|NCT02055820|Secondary|Prednisone Plasma PK: Tmax|Tmax was determined based on measurement of Predisone concentrations in plasma over time.|Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)|PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. A similar dose strength of prednisone (100 mg) was administered across the treatment arms/venetoclax dose groups. Hence, the data are presented as an overall summary in Cycles 1 and 2.|||Hour||Standard Deviation|Mean
2610450|NCT02055976|Secondary|Change From Baseline in High Density Lipoprotein- Cholesterol (HDL-C) at Day 85 and Day 113|HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610451|NCT02055976|Secondary|High Density Lipoprotein- Cholesterol (HDL-C)|HDL-C is cholesterol in the bloodstream that is carried by high density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.|Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610452|NCT02055976|Secondary|Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113|Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||percent change||Standard Deviation|Mean
2610453|NCT02055976|Secondary|Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 85 and Day 113|Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610454|NCT02055976|Secondary|Lipoprotein (a) (Lp[a])|Lp(a) is a lipoprotein subclass which consists of an LDL-like particle and the specific apolipoprotein(a). Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.|Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610455|NCT02055976|Secondary|Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113|ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||percent change||Standard Deviation|Mean
2610456|NCT02055976|Secondary|Change From Baseline in Apolipoprotein A-II (ApoA-II) at Day 85 and Day 113|ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610457|NCT02055976|Secondary|Apolipoprotein A-II (ApoA-II)|ApoA-II is the second most abundant component of the HDL cholesterol. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.|Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610458|NCT02055976|Secondary|Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113|ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||percent change||Standard Deviation|Mean
2610459|NCT02055976|Secondary|Change From Baseline in Apolipoprotein A-I (ApoA-I) at Day 85 and Day 113|ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610460|NCT02055976|Secondary|Apolipoprotein A-I (ApoA-I)|ApoA1 is a major protein that is a component of HDL cholesterol and helps in clearing cholesterol from the blood by removing cholesterol from organs and tissues to be destroyed by the liver. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.|Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610461|NCT02055976|Secondary|Percent Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113|ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||percent change||Standard Deviation|Mean
2610462|NCT02055976|Secondary|Change From Baseline in Apolipoprotein B (ApoB) at Day 85 and Day 113|ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610463|NCT02055976|Secondary|Apolipoprotein B (ApoB)|ApoB is a major protein that makes up LDL cholesterol and is involved in transporting cholesterol and triglycerides to cells and tissues in the body. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.|Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610464|NCT02055976|Secondary|Percent Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113|Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||percent change||Standard Deviation|Mean
2610485|NCT02055820|Secondary|Prednisone Plasma PK: AUC|AUC was determined based on measurement of Predisone concentrations in plasma over time.|Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)|PK evaluable population: All participants who received study drug and provided at least one post-treatment PK sample. A similar dose strength of prednisone (100 mg) was administered across the treatment arms/venetoclax dose groups. Hence, the data are presented as an overall summary in Cycles 1 and 2.|||hr*mcg/mL||Standard Deviation|Mean
2610465|NCT02055976|Secondary|Change From Baseline in Total Cholesterol (TC) at Day 85 and Day 113|Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610466|NCT02055976|Secondary|Total Cholesterol (TC)|Total cholesterol is the sum of all the cholesterol within the blood. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.|Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610467|NCT02055976|Secondary|Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85 and Day 113|LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Change from baseline = observed value minus baseline value.|Baseline, Day 85, 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610468|NCT02055976|Secondary|Low Density Lipoprotein-Cholesterol (LDL-C)|LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value.|Baseline, Day 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, 106, 113, 127, 141, 155, 169|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mg/dL||Standard Deviation|Mean
2610469|NCT02055976|Primary|Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 113|LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.|Baseline, Day 113|FAS included all the participants who were randomized and administered at least 1 dose of study treatment. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.|||percent change||Standard Deviation|Mean
2610470|NCT02055976|Primary|Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 85|LDL-C is cholesterol in the bloodstream that is carried by low density lipoprotein. Fasting was required at least 10 hours before blood sample collection. Baseline was defined as the mean of the last two non-missing measurements collected prior to the first dose of study treatment. Both measurements must be within 10 days prior to the first dose of study treatment; if only one measurement was available 10 days prior to the first dose of study treatment, then that measurement served as the baseline value. Percent change from baseline = ([observed value divided by baseline value] minus 1) multiplied by 100.|Baseline, Day 85|Full analysis set (FAS) included all the participants who were randomized and administered at least 1 dose of study treatment.|||percent change||Standard Deviation|Mean
2610471|NCT02055820|Secondary|Relative Dose Intensity of Venetoclax|Dose intensity was categorized as < 80%, 80% to < 85%, 85% to < 90%, or >/= 90%.|Baseline up to Cycle 6 (cycle length = 21 days)|Safety population: All patients who enrolled in the study and received any amount of venetoclax or R-CHOP/G-CHOP were included in the safety population for safety analyses|||Percentage of Partcipants|||Number
2610472|NCT02055820|Secondary|Safety: Percentage of Participants Maintaining Relative Dose Intensity of CHOP Chemotherapy|Maintenance of relative dose intensity was defined as a dose intensity of >/= 90%.|Baseline up to Cycle 6 (cycle length = 21 days)|Safety population: All patients who enrolled in the study and received any amount of venetoclax or R-CHOP/G-CHOP were included in the safety population for safety analyses. Overall R-CHOP and G-CHOP arms were analyzed for this outcome measure.|||Percentage of participants|||Number
2610473|NCT02055820|Secondary|Safety: Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline up to approximately 36 months|Safety population: All patients who enrolled in the study and received any amount of venetoclax or R-CHOP/G-CHOP were included in the safety population for safety analyses|||Percentage of Participants|||Number
2610611|NCT02054156|Primary|Time to a Protocol-defined Pulmonary Exacerbation|Time to a protocol-defined pulmonary exacerbation requiring oral, inhaled, or intravenous antibiotics, using a prespecified definition available in the study protocol.|Over the 18-month study period||||years||95% Confidence Interval|Median
2610474|NCT02055820|Secondary|Percentage of Participants With CR Defined by Computed Tomography (CT) Scan Using the Modified Lugano Classification|CR was defined as follows according to modified Lugano classification for CT-based response: Target nodes/nodal masses must have regressed to </= 1.5 cm in longest transverse diameter of a lesion (LDi), no extra-lymphatic sites of disease, absence of non-measured lesions, organ enlargement must have regressed to normal, no new lesions, and if the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.|Baseline up to disease progression or death due to any cause, whichever occurs first (up to approximately 36 months)|Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available.|||Percentage of Participants||95% Confidence Interval|Number
2610475|NCT02055820|Secondary|Percentage of Participants Who Are Alive and Without Disease Progression at Month 12|Progressive disease (PD) was determined using the modified Lugano classification criteria. For PET-CT-based PD: Score 4 (uptake moderately > liver) or 5 (uptake markedly higher than liver and/or new lesions) with an increase in intensity of uptake from baseline in target nodes and nodal lesions, new FDG-uptake foci of extranodal lesions consistent with lymphoma at interim or end-of-treatment assessment, no non-measured lesions, new FDG-uptake foci consistent with lymphoma, new or recurrent FDG-uptake foci in bone marrow. For CT-based PD: >/= 50% decrease in SPD of up to 6 target measureable nodes and extranodal sites; non-measured lesion should be absent/normal, have regressed, but not increased; no new lesions.|Month 12|Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available.|||Percentage of Participants||95% Confidence Interval|Number
2610476|NCT02055820|Secondary|Percentage of Participants With Objective Response Defined as Partial Response (PR) or Complete Response (CR) Using the Modified Lugano Classification Assessed by IRC|"Objective Response defined as PR (partial response) or CR (complete response) at end of treatment.~CR: Lymph nodes and extra-lymphatic sites with score 1, 2 or 3 on a 5-point scale (with a higher score being a worse outcome). No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.~PR: Lymph nodes and extralymphatic sites with score of 4 or 5 on the 5-point scale with reduced uptake compared with baseline and residual mass(es) of any size. CT-based response criteria for PR must also be met. No new lesions. In bone marrow residual uptake could be higher than in normal marrow but must be reduced compared with baseline; persistent focal changes in the marrow to be considered for further evaluation with magnetic resonance imaging (MRI) or biopsy or an interval scan. OR=PR+CR"|Baseline up to disease progression or death due to any cause, whichever occurs first (up to approximately 36 months)|Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available.|||Percentage of Participants||95% Confidence Interval|Number
2610477|NCT02055820|Secondary|Vincristine PK: Cmax|Cmax was determined using the post-dose Vincristine plasma concentrations.|End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)|PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Given a single dose strength of Vincristine was administered across the different Venetoclax dose groups and treatment arms, hence the data are presented as an overall summary.|||mcg/mL||Standard Deviation|Mean
2610478|NCT02055820|Secondary|Doxorubicin PK: Cmax|Cmax was determined using the post-dose Doxorubicin plasma concentrations.|End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)|PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Given a single dose strength of Doxorubicin was administered across the different Venetoclax dose groups and treatment arms, hence the data are presented as an overall summary.|||mcg/mL||Standard Deviation|Mean
2610479|NCT02055820|Secondary|Cyclophosphamide PK: Cmax|Cmax was determined using the post-dose Cyclophosphamide plasma concentrations on Cycle 1 Day 1.|End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)|PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Given a single dose strength of Cyclophosphamide was administered across the different Venetoclax dose groups and treatment arms, hence the data are presented as an overall summary.|||mcg/mL||Standard Deviation|Mean
2610480|NCT02055820|Secondary|Obinutuzumab PK: Cmax|Cmax was determined using the post-dose obinutuzumab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1.|End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)|PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. The Cmax of obinutuzumab is presented at the 800 mg Venetoclax dose group. Hence, the data is not presented by the treatment arms/Venetoclax dose groups.|||mcg/mL||Standard Deviation|Mean
2610481|NCT02055820|Secondary|Rituximab PK: Cmin Within the Dosing Interval|Cmin was determined using the pre-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose on Day 1 of Cycle 2.|Pre-dose on Cycle 2 Day 1 (cycle length = 21 days)|PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. The Cmin of rituximab is presented at the 800 mg Venetoclax dose group. Hence, the data is not presented by the treatment arms/Venetoclax dose groups.|||mcg/mL||Standard Deviation|Mean
2610482|NCT02055820|Secondary|Rituximab PK: Cmax|Cmax was determined using the post-dose rituximab plasma concentrations at the 800 mg Venetoclax Dose using the end of infusion time point on Cycle 1 Day 1.|End of Infusion on Cycle 1 Day 1 (cycle length = 21 days)|PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. The Cmax of rituximab is presented at the 800 mg Venetoclax dose group. Hence, the data is not presented by the treatment arms/Venetoclax dose groups.|||mcg/mL||Standard Deviation|Mean
2610483|NCT02055820|Secondary|Prednisone Plasma PK: Cmax|Cmax was determined based on measurement of Predisone concentrations in plasma over time.|Predose (within 30 minutes) and 0.5, 1, 2, 4, 6 Hr after prednisone dose on Day 1 of Cycle 1 and 2 (cycle length = 21 days)|PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. A similar dose strength of prednisone (100 mg) was administered across the treatment arms/venetoclax dose groups. Hence, the data are presented as an overall summary in Cycles 1 and 2.|||Ng/ML||Standard Deviation|Mean
2610486|NCT02055820|Secondary|Venetoclax Plasma PK: Minimum Plasma Concentration (Cmin) Within the Dosing Interval|Cmin was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.|Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)|PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Reporting according to study drug received. One participant mistakenly received only 100 mg instead of the planned 200 mg dose and was reported in a separate arm for PK outcome measures.|||mcg/mL||Standard Deviation|Mean
2610487|NCT02055820|Secondary|Venetoclax Plasma PK: Maximum Observed Plasma Concentration (Cmax)|"Cmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.~Data are reported as micrograms per milliliter"|Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)|PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Reporting according to study drug received. One participant mistakenly received only 100 mg instead of the planned 200 mg dose and was reported in a separate arm for PK outcome measures.|||Ug/ML||Standard Deviation|Mean
2610488|NCT02055820|Secondary|Venetoclax Plasma PK: Time to Maximum Observed Plasma Concentration (Tmax)|Tmax was determined based on measurement of venetoclax concentrations in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.|Predose (within 30 minutes) & 2, 4, 6, 8 Hr postdose on Cycle 1 Day 4 (cycle length = 21 days)|PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Reporting according to study drug received. One participant mistakenly received only 100 mg instead of the planned 200 mg dose and was reported in a separate arm for PK outcome measures.|||Hour||Standard Deviation|Mean
2610489|NCT02055820|Secondary|Venetoclax Plasma PK: Area Under the Plasma Concentration-Time Curve (AUC)|"AUC was calculated based on measurement of venetoclax concentration in plasma over time. Venetoclax exposure was pooled across Phase I and II for the R-CHOP 800 mg cohorts.~Data are reported as hour*micrograms per milliliter (hr*mcg/mL)"|Predose (within 30 minutes) & 2, 4, 6, 8 hours (Hr) postdose on Cycle 1 Day 4 (cycle length = 21 days)|PK evaluable population: All patients who received study drug and provided at least one post-treatment PK sample for whom data were available. Reporting according to study drug received. One participant mistakenly received only 100 mg instead of the planned 200 mg dose and was reported in a separate arm for PK outcome measures.|||hr*mcg/mL||Standard Deviation|Mean
2610490|NCT02055820|Primary|Percentage of Participants With CR Defined by PET/CT Scan in Dual Expressor Diffuse Large B-Cell Lymphoma (DE-DLBCL) Participants Assessed by IRC|CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake </= mediastinum; 3) uptake < mediastinum but </= liver. No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy.|Baseline up to end of treatment (up to approximately 36 months)|Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available.|||Percentage of participants||95% Confidence Interval|Number
2610491|NCT02055820|Primary|Percentage of Participants With Complete Response (CR) Defined by Positron Emission Tomography-Computed Tomography (PET/CT) Scan Using the Modified Lugano Classification Assessed by Independent Review Committee (IRC)|CR was defined as follows according to modified Lugano classification for PET/CT-based response: Lymph nodes and extra-lymphatic sites with score 1, 2, or 3 with or without a residual mass on 5-point scale with 1) no uptake above background; 2) uptake </= mediastinum; 3) uptake < mediastinum but </= liver. No evidence of fluorodeoxyglucose (FDG)-uptake disease in marrow. If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy|Baseline up to end of treatment (up to approximately 36 months)|Intent-to-treat (ITT) population: All participants who enrolled in the study were included in the ITT population. Data reported for all participants for whom data were available.|||Percentage of participants||95% Confidence Interval|Number
2610492|NCT02055820|Primary|Safety: Number of Participants With Dose-Limiting Toxicities (DLTs)|DLTs were reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0). Decrease in B cells, lymphopenia, and leukopenia caused by lymphopenia were not considered DLTs but instead were expected outcomes of study treatment. Any Grade >/= 3 adverse event, that was attributed to having a reasonable possibility of being related to the combined administration of venetoclax plus R-CHOP or G-CHOP, that could not be attributed by the investigator to an alternative, clearly identifiable cause such as tumor progression, concurrent illness or medical condition, or concomitant medication and that occurred during the DLT observation period (start of venetoclax treatment through end of Cycle 2) was considered a DLT for dose-escalation purposes. Grade 3 or 4 neutropenia or thrombocytopenia identified on Day 1 of Cycle 2 or 3, resulting in dose delay were considered DLTs.|Start of venetoclax administration (Cycle 1 Day 4 or 3 days after first CHOP dose) up to end of Cycle 2 (cycle length = 21 days)|Safety population: All participants who enrolled in the study and received any amount of venetoclax or R-CHOP/G-CHOP were included in the safety population for safety analyses. Here, participants in the Dose Finding phase were analyzed.|||Participants|||Number
2610493|NCT02055638|Primary|Safety and Tolerability, Measured as the Number of Participants With Adverse Events|Number of participants with adverse events|up to 8 weeks|Intent to treat|||participants|||Number
2610494|NCT02055430|Other Pre-specified|Factors Affecting the Outcome of Each Group (Operative Time, Safety and Efficacy)|"age, site of stones, size of stones, degree of hydronephrosis~they were calculated per 45 ureterorenal units in PCN group and 90 ureterorenal units in Double J group"|1 week|||||||
2610495|NCT02055430|Secondary|The Number of Subsequent Interventions Needed for Clearance of Stones .|The number of subsequent interventions needed for clearance of stones after normalization of serum creatinine in relation to initial urinary drainage method using percutaneous nephrostomy or ureteric stent in children with Obstructive Anuria and Acute Renal Failure|6 months|||||||
2614843|NCT02006758|Primary|Mean Change in Office Systolic Blood Pressure at 6 Months||Baseline and 6 months|58 out of 67 participants analyzed for primary outcome measure of office systolic blood pressure at 6 months.|||mmHg||Standard Deviation|Mean
2610497|NCT02055430|Primary|Period to Return to Normal Creatinine|"period required for normalization of serum creatinine after initial urinary drainage using percutaneous nephrostomy or ureteric stent in children with obstructive calcular anuria and Acute Renal Failure~serum creatinine was compared to normal values in matched healthy children"|1 week||||days||Standard Deviation|Mean
2610498|NCT02055404|Primary|Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable)|"Each lens (containing 8 rotation marks and one reference mark, in total 9 marks) was assessed for visibility by 10 investigators using the following scale: N/A; Not visible; Slightly visible, not acceptable; Slightly visible, acceptable; Clearly visible; More visible than necessary. Visibility assessments were made after all marks had been evaluated. S9 Mark (test lens) functioned as a starting marker only and was not rated. The control lens was not used as a comparison, but rather as a reference for what a mark looks like on a commercial product. Visibility of Rotation Mark is reported as the percentage of assessments rating the rotation mark as Clearly visible or Slightly visible, acceptable."|Day 1|The analysis population includes all enrolled participants. Assessments from all 10 investigators were analyzed, hence sample size for each rotational mark is 30.|||Percentage of assessments|||Number
2610499|NCT02055365|Primary|Number of Significantly Differentially Expressed Genes at False Discovery Rate (FDR)< 0.05 (Upon Correction for Multiple Testing).|Number of significantly differentially expressed genes at time point versus prevaccination baseline (FDR<0.05). Following Principal Components Analysis, data from one participant series was identified as a technical outlier and excluded from downstream analyses. Differential gene expression analysis was conducted with the voom/limma tools in the R statistical framework.|Day 1, Day 3, Week 1, and Week 2|All participants received the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant). RNA-Seq data from whole blood (PAXgene) for 9 participants were analyzed for differential gene expression at day 1, day 3, week 1, and week 2 after administration of the Hepatitis B Vaccine (Recombinant) (dose #1).|||number of genes at FDR<0.05|||Number
2610500|NCT02055365|Primary|Number of Differentially Expressed Genes at p < 0.05 (Without Multiple Testing Correction).|Number of differentially expressed genes at time point versus prevaccination baseline (p<0.05). Following Principal Components Analysis, data from one participant series was identified as a technical outlier and excluded from downstream analyses. Differential gene expression analysis was conducted with the voom/limma tools in the R statistical framework.|Day 1, Day 3, Week 1, and Week 2|All participants received the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant). RNA-Seq (RNA sequencing) data from whole blood (PAXgene) for 9 participants were analyzed for differential gene expression at day 1, day 3, week 1, and week 2 after administration of the Hepatitis B Vaccine (Recombinant) (dose #1).|||number of genes at p<0.05|||Number
2610501|NCT02055352|Secondary|Change in Health Status - SGRQ-C|St George's Respiratory Questionnaire short version questionnaire will be completed by participants. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)|Baseline, week 12 and week 24|Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients were analyzed according to the treatment they are randomized to|||Score on a scale||Standard Error|Least Squares Mean
2610502|NCT02055352|Secondary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second at Week 24 (Analysis of Superiority)|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.|Baseline and week 24|Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients were analyzed according to the treatment they are randomized to|||Liters||Standard Error|Least Squares Mean
2610503|NCT02055352|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Used Over the 24 Week Treatment|A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours.|24 weeks|Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients that were not discontinued before Visit 3 (day 28±3).|||Puffs||Standard Deviation|Mean
2610504|NCT02055352|Secondary|Change in Health Status - mMRC|Modified Medical Research Council scale (mMRC) questionnaire will be completed by participants. 0 Not troubled with breathlessness except with strenuous exercise; 1 Troubled by shortness of breath when hurrying on the level or walking up a slight hill; 2 Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on the level; 3 Stops for breath after walking about 100 yards or after a few minutes on the level; 4 Too breathless to leave the house or breathless when dressing or undressing|Baseline, week 12 and week 24|Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients were analyzed according to the treatment they are randomized to|||Score on a scale||Standard Error|Least Squares Mean
2610505|NCT02055352|Primary|Change From Baseline in Trough Forced Expiratory Volume in 1 Second (Non-inferiority Analysis).|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Baseline and week 12|Per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Major protocol deviations were defined in the validation analysis plan prior to database lock and the unblinding of the study. Patients were analyzed according to the treatment they are randomized to|||Liters||Standard Error|Least Squares Mean
2610515|NCT02055118|Secondary|Change From Baseline in the Concentration of Glycosaminoglycans (GAG) in Cerebrospinal Fluid (CSF) at Week 52|Change from baseline in the concentration of GAG in CSF was reported.|Baseline, Week 52|PK population with number of participants evaluable for this outcome measure.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2610516|NCT02055118|Secondary|Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed (CL/F) of Idursulfase After IT Administration|The CL/F of idursulfase after IT administration was reported.|Pre-dose, 30, 60, 120 minutes, 4, 6, 8, 12, 24, 30 and 36 hour (h) post-dose on Weeks 4, 24, and 48|PK population with number of participants evaluable for this outcome measure.|||Liter per hour (L/h)||Standard Deviation|Mean
2610506|NCT02055118|Secondary|Raw Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population|Participants who were younger than 3 years were assessed using the BSID-III. The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. Raw scores are converted to scaled scores that are based on normed populations. Raw score ranges: Cognitive scale 0-91, Receptive communication 0-49, Expressive communication 0-48, Fine motor 0-66 and Gross motor 0-72. Higher values indicate better outcomes. Participant wise data at evaluable timepoints was reported for this outcome.|Baseline up to Week 52|Substudy population included all participants enrolled and treated with investigational product in the substudy.|||score on a scale|||Number
2610507|NCT02055118|Secondary|Development Quotient (DQ) of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population|Participants who were younger than 3 years were assessed using the BSID-III. The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The development quotient (DQ) is a means to express a neurodevelopmental/cognitive delay which will be computed as a ratio and expressed as a percentage using the age equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range: 0-100). Higher values present better outcomes. Participant wise data at evaluable timepoints was reported for this outcome.|Baseline up to Week 52|Substudy population included all participants enrolled and treated with investigational product in the substudy.|||Percentage of chronological age|||Number
2610508|NCT02055118|Secondary|Chronological Age of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population|Participants who were younger than 3 years were assessed using the BSID-III. The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. Chronological age of the participants when assessed by the BSID-III scale was reported. Range 16.59 - 45.21 months. Participant wise data at evaluable timepoints was reported for this outcome.|Baseline up to Week 52|Substudy population included all participants enrolled and treated with investigational product in the substudy.|||Months|||Number
2610509|NCT02055118|Secondary|Age Equivalent Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population|Participants who were younger than 3 years were assessed using the BSID-III. The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. Standardized scores (range 40-160) were converted to age- equivalent scores to measure ability, skill, and knowledge expressed as the age at which most individuals reach the same level (age norm; range: 0, unbound). Higher values present better outcomes. Participant wise data at evaluable timepoints was reported for this outcome.|Baseline up to Week 52|Substudy population included all participants enrolled and treated with investigational product in the substudy.|||Score on a scale|||Number
2610510|NCT02055118|Secondary|Percentile Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population|Participants who were younger than 3 years were assessed using the BSID-III. The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. Percentile scores range from 1 to 99 with 50 as the mean and median. Higher percentile means higher the rank of the child relative to the normed population. Participant wise data at evaluable timepoints was reported for this outcome.|Baseline up to Week 52|Substudy population included all participants enrolled and treated with investigational product in the substudy.|||Percentile score|||Number
2610511|NCT02055118|Secondary|Composite Scores of Bayley Scales of Infant Development (BSID-III) Scale in Substudy Population|Participants who were younger than 3 years were assessed using the BSID-III. The BSID--III is a series of measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers and consists of a series of developmental play tasks. The composite score for the cognitive scale, language scale, and motor scale are normed and have a mean=100, SD=15 and range of 40-160. Higher values denote stronger skills and abilities in the domain, indicating better outcomes. Participant wise data at evaluable timepoints was reported for this outcome.|Baseline up to Week 52|Substudy population included all participants enrolled and treated with investigational product in the substudy.|||Score on a scale|||Number
2610512|NCT02055118|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Intrathecal Drug Delivery Device (IDDD)-Related Adverse Events|An adverse event (AE) was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered investigational product-related. Treatment-emergent AEs for the no IT treatment group were defined as all AEs occurring on or after the date of randomization and at or before the end of the study (EOS) visit. Treatment-emergent AEs for the IT treatment group were defined as all AEs occurring on or after the date of the first IDDD implant surgery or Treatment-Emergentfirst dose of the investigational product (whichever was earlier) and at or before the EOS visit (+30 days) or 2 weeks after the removal of the last IDDD (whichever was later).|From start of study treatment up to Week 53|Safety population included all randomized participants with any post-randomization safety assessments, analyzed according to the treatment received.|||Participants|||Count of Participants
2610513|NCT02055118|Secondary|Participant Response to Quality of Life EuroQol-5D (EQ-5D) Questionnaire at Week 52|The EQ-5D provides a descriptive profile and index value for health status. The questionnaire measures 5 dimensions of health status: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, there are 5 levels of response: no problems, slight problems, moderate problems, severe problems, and unable to do/extreme problems.|Week 52|ITT population included all randomized participants.|||Participants|||Count of Participants
2610514|NCT02055118|Secondary|Concentration of Idursulfase in Cerebrospinal Fluid (CSF)|CSF samples were collected via the IDDD or lumbar puncture prior to the injection of Idursulfase-IT.|Pre-dose on Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48|PK population with number of participants evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2610873|NCT02048878|Primary|Sympathetic Baroreflex Sensitivity (BRS) Unit|Direct recording of sympathetic nervous activity in a nerve of the lower leg using a micro-electrode.|2 months after enrollment||||bursts per 100 heart beats per mm Hg||Standard Deviation|Mean
2610517|NCT02055118|Secondary|Terminal Half-life (t1/2) of Idursulfase After IT Administration|The t1/2 of idursulfase after IT administration was reported.|Pre-dose, 30, 60, 120 minutes, 4, 6, 8, 12, 24, 30 and 36 hour (h) post-dose on Weeks 4, 24, and 48|PK population with number of participants evaluable for this outcome measure.|||Hour (h)||Standard Deviation|Mean
2610518|NCT02055118|Secondary|Area Under the Concentration Versus Time Curve From Zero From the Time of Dosing to the Last Measurable Concentration (AUC0-t) of Idursulfase After IT Administration|The AUC0-t of idursulfase after IT administration was reported.|Pre-dose, 30, 60, 120 minutes, 4, 6, 8, 12, 24, 30 and 36 hour (h) post-dose on Weeks 4, 24, and 48|PK population with number of participants evaluable for this outcome measure.|||Nanogram*hour per milliliter (ng*h/mL)||Standard Deviation|Mean
2610519|NCT02055118|Secondary|Time to Reach Maximum Drug Concentration (Tmax) of Idursulfase After IT Administration|The tmax of idursulfase after IT administration was reported.|Pre-dose, 30, 60, 120 minutes, 4, 6, 8, 12, 24, 30 and 36 hour (h) post-dose on Weeks 4, 24, and 48|PK population with number of participants evaluable for this outcome measure.|||Hour (h)||Standard Deviation|Mean
2610520|NCT02055118|Secondary|Maximum Observed Drug Concentration (Cmax) of Idursulfase After IT Administration|The Cmax of idursulfase after IT administration was reported.|Pre-dose, 30, 60, 120 minutes, 4, 6, 8, 12, 24, 30 and 36 hour (h) post-dose on Weeks 4, 24, and 48|Pharmacokinetic (PK) population included all participants who received investigational product and participated in the scheduled PK studies, and for whom at least 1 post-dose PK blood sample was collected. PK population with number of participants evaluable for this outcome measure.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2610521|NCT02055118|Secondary|Observed Maladaptive Levels of Maladaptive Behavior Index and Its Sub-scales of Vineland Adaptive Behavior Scales, Second Edition (VABS-II)|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. Maladaptive behavior index (MBI) is a composite of the internalizing, externalizing, and other types of undesirable behavior that may interfere with the individual's adaptive functioning. The V scale scores represent a score (mean = 15 and standard deviation of 3; range: 1-24) on which higher scores indicate greater maladaptive behaviors. The v-scale score ranges for MBI, externalizing and internalizing scores are defined as clinically significant: 21-24, elevated: 18-20, average: 1-17.|Baseline, Week 16, Week 28, Week 40 and Week 52|ITT population included all randomized participants.|||Participants|||Count of Participants
2610522|NCT02055118|Secondary|Change From Baseline of V-Scale Scores of Maladaptive Behavior Index and Its Sub-scales at Weeks 16, 28, 40 and 52|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. Maladaptive behavior index is a composite of the internalizing, externalizing, and other types of undesirable behavior that may interfere with the individual's adaptive functioning. The V-scale scores represent a score (mean = 15 and standard deviation of 3; range: 1-24) on which higher scores indicate greater maladaptive behaviors. A positive change value indicates increase of maladaptive behavior.|Baseline, Week 16, Week 28, Week 40 and Week 52|ITT population included all randomized participants.|||Score on a scale||Standard Deviation|Mean
2610523|NCT02055118|Secondary|Change From Baseline of V-Scale Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. This test measures the following 4 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The V-scale scores represent a score (mean = 15 and standard deviation of 3; range: 1-24) on which higher scores indicate a higher level of adaptive functioning. A positive change value indicates improvement in adaptive functioning.|Baseline, Week 16, Week 28, Week 40 and Week 52|ITT population included all randomized participants.|||Score on a scale||Standard Deviation|Mean
2610524|NCT02055118|Secondary|Change From Baseline of Development Quotients of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range, 0, 100). The overall DQ score is calculated from the mean age-equivalent score obtained by averaging out the age equivalent scores for the all the sub-domains except for Gross and Fine motor skills. This test measures the following 4 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). A positive value indicates improvement in health and cognition.|Baseline, Week 16, Week 28, Week 40 and Week 52|ITT population included all randomized participants.|||Percentage of chronological age||Standard Deviation|Mean
2610525|NCT02055118|Secondary|Change From Baseline of Age Equivalents Scores of Sub-domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Weeks 16, 28, 40 and 52|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. Standardized scores (range 40-160) were converted to age equivalent scores to measure ability, skill, and knowledge expressed as the age at which most individuals reach the same level. The mean age equivalent score is obtained by averaging out the age-equivalent scores for the all the sub-domains except for Gross and Fine motor skills (range: 0, unbound). A positive value indicates improvement in health and cognition.|Baseline, Week 16, Week 28, Week 40 and Week 52|ITT population included all randomized participants.|||Score on a scale||Standard Deviation|Mean
2610526|NCT02055118|Secondary|Change From Baseline of T-scores for School Age of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52|"The DAS-II was used to assess cognitive development in all randomized participants. The school age battery is designed for children ages 7 years 0 months through 17 years 11 months. The higher score indicates greater cognitive ability. The subtest score represent a score (mean = 50 and standard deviation of 10) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in cognitive ability. In the below table, SQR stands for Sequential & Quantitative Reasoning."|Baseline, Week 16, Week 28, Week 40 and Week 52|ITT population with number of participants evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
2610527|NCT02055118|Secondary|Change From Baseline of T-scores for Early Years of Core Subtests of the Differential Ability Scale, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52|The DAS-II was used to assess cognitive development in all randomized participants. The early years battery is designed for children ages 2 years 6 months through 6 years 11 months. The higher score indicates greater cognitive ability. The subtest score represent a score (mean = 50 and standard deviation of 10) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in cognitive ability.|Baseline, Week 16, Week 28, Week 40 and Week 52|ITT population with number of participants evaluable for this outcome measure.|||T-score||Standard Deviation|Mean
2610528|NCT02055118|Secondary|Change From Baseline of Development Quotients for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52|"The DAS-II was used to assess cognitive development in all randomized participants. The school age battery is designed for children ages 7 years 0 months through 17 years 11 months. The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range, 0, 100). The higher score indicates greater cognitive ability. The subtest score represent a score (mean = 50 and standard deviation of 10) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in cognitive ability. In the below table, SQR stands for Sequential & Quantitative Reasoning."|Baseline, Week 16, Week 28, Week 40 and Week 52|ITT population with number of participants evaluable for this outcome measure.|||Percentage of chronological age||Standard Deviation|Mean
2610529|NCT02055118|Secondary|Change From Baseline of Development Quotients for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52|The DAS-II was used to assess cognitive development in all randomized participants. The early years battery is designed for children ages 2 years 6 months through 6 years 11 months. The DQ is a means to express a neurodevelopmental/cognitive delay. The DQ was computed as a ratio and expressed as a percentage using the age-equivalent score divided by the age at testing ([age-equivalent score/chronological age] × 100; range, 0, 100). The higher score indicates greater cognitive ability. The subtest score represent a score (mean = 50 and standard deviation of 10) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in cognitive ability.|Baseline, Week 16, Week 28, Week 40 and Week 52|ITT population with number of participants evaluable for this outcome measure.|||Percentage of chronological age||Standard Deviation|Mean
2610530|NCT02055118|Secondary|Change From Baseline of Age Equivalents for School Age of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52|"The DAS-II was used to assess cognitive development in all randomized participants. The school age battery is designed for children ages 7 years 0 months through 17 years 11 months. Standardized scores were converted to age equivalent scores to measure ability, skill, and knowledge expressed as the age at which most individuals reach the same level. The mean age equivalent score is obtained by averaging out the age-equivalent scores. The higher score indicates greater cognitive ability. The subtest score represents a score (mean = 50 and standard deviation of 10) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in cognitive ability. In the below table, SQR stands for Sequential & Quantitative Reasoning."|Baseline, Week 16, Week 28, Week 40 and Week 52|ITT population with number of participants evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
2610531|NCT02055118|Secondary|Change From Baseline of Age Equivalent Score for Early Years of Core Subtests of the Differential Ability Scales, Second Edition (DAS-II) at Weeks 16, 28, 40 and 52|The DAS-II was used to assess cognitive development in all randomized participants. The early years battery is designed for children ages 2 years 6 months through 6 years 11 months. Standardized scores were converted to age equivalent scores to measure ability, skill, and knowledge expressed as the age at which most individuals reach the same level. The mean age equivalent score is obtained by averaging out the age-equivalent scores. The higher score indicates greater cognitive ability. The subtest score represent a score (mean = 50 and standard deviation of 10) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in cognitive ability.|Baseline, Week 16, Week 28, Week 40 and Week 52|ITT population with number of participants evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
2610532|NCT02055118|Secondary|Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Standard Scores of Other Domains at Weeks 16, 28, 40, 52|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. This test measures the following 4 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The standard scores represent a score (mean = 100 and standard deviation of 15) on which higher scores indicate a higher level of cognitive ability. A positive change value indicates improvement in adaptive functioning. Communication, daily living skills, socialization and motor skills domains were reported here. The range for individual standard scores is 20-160.|Baseline, Week 16, Week 28, Week 40 and Week 52|ITT population included all randomized participants.|||Score on a scale||Standard Error|Least Squares Mean
2610533|NCT02055118|Secondary|Change From Baseline in Differential Ability Scales, Second Edition (DAS-II) Cluster Standard Scores at Weeks 16, 28, 40 and 52|The DAS-II was used to assess cognitive development in all randomized participants. The cluster scores represent a score (mean = 100 and standard deviation of 15) on which higher scores indicate a higher level of cognitive ability in each cluster: verbal (score range: 31-169), nonverbal (score range: 31-166) and spatial (score range: 32-170).|Baseline, Week 16, Week 28, Week 40 and Week 52|ITT population included all randomized participants.|||Score on a scale||Standard Error|Least Squares Mean
2610547|NCT02054897|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline (week 0) in FPG was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 30|Full analysis set. Number of subject analysed=subjects who contributed to the analysis.|||mmol/L||Standard Deviation|Mean
2610906|NCT02047500|Secondary|Progression Free Survival (PFS) Time||Time from enrollment to progressive disease (PD) or occurrence of death due to any cause within 120 days of either first administration of study drug or the last tumor assessment|||||||
2610534|NCT02055118|Secondary|Change From Baseline in the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Adaptive Behavior Composite (ABC) Score at Week 16, 28 and 40|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. This test measures the following 4 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The ABC score ranges from 20 to 160 on which higher scores indicate a higher level of adaptive functioning. A positive change value indicates improvement in adaptive functioning.|Baseline, Week 16, Week 28 and Week 40|ITT population included all randomized participants.|||Score on a scale||Standard Error|Least Squares Mean
2610535|NCT02055118|Secondary|Change From Baseline in the Differential Ability Scales, Second Edition (DAS-II) General Conceptual Ability (GCA) Standard Score at Weeks 16, 28 and 40|The DAS-II was used to assess cognitive development in all randomized participants. The GCA standard score of the DAS-II was used to obtain a general measure of cognitive ability. The GCA score represent a score (mean = 100 and standard deviation of 15) on which higher scores indicate a higher level of cognitive ability. The score ranges from 30 to 170. A positive change value indicates improvement in cognitive ability.|Baseline, Week 16, Week 28 and Week 40|ITT population included all randomized participants.|||Score on a scale||Standard Error|Least Squares Mean
2610536|NCT02055118|Secondary|Change From Baseline in the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) Adaptive Behavior Composite (ABC) Score at Week 52|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. This test measures the following 4 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (a composite of the other 4 domains). The ABC score ranges from 20 to 160 on which higher scores indicate a higher level of adaptive functioning. A positive change value indicates improvement in adaptive functioning.|Baseline, Week 52|ITT population with number of participants evaluable for this outcome measure.|||Score on a scale||Standard Error|Least Squares Mean
2610537|NCT02055118|Primary|Change From Baseline in the Differential Ability Scales, Second Edition (DAS-II) General Conceptual Ability (GCA) Standard Score at Week 52|The DAS-II was used to assess cognitive development in all randomized participants. The GCA standard score of the DAS-II was used to obtain a general measure of cognitive ability. The GCA score represent a score (mean = 100 and standard deviation of 15) on which higher scores indicate a higher level of cognitive ability. The score ranges from 30 to 170. A positive change value indicates improvement in cognitive ability.|Baseline, Week 52|ITT population with number of participants evaluable for this outcome measure.|||Score on a scale||Standard Error|Least Squares Mean
2610538|NCT02054910|Secondary|% of Subjects in Each Group That Are Employed at 6 Months Post Procedure.|Subjects will be asked about employment at 6 months post procedure|baseline to 6 months|All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject||||||
2610539|NCT02054910|Secondary|Mean Number of Times Subjects in Each Group Accessed the Health Care System Within 6 Months Post Procedure|The number of times each subject accessed the health care system will be collected, and then the mean will be calculated for each group|baseline to 6 months|All subjects were lost to follow up by 6 months; since everyone dropped out at different times before the 6 month point, the data would not be evaluable.||||||
2610540|NCT02054910|Secondary|Mean Mental State Between Groups Using the Beck's Depression Index at 6 Months.|"The Beck's Depression scale was used to indicate subject's depression:~0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression."|baseline to 6 months|All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject||||||
2610541|NCT02054910|Secondary|Number of Subject in Each Group Requiring Administration of Narcotics During 6 Months Post Baseline|the number of subjects receiving a narcotic drug during the 6 months post baseline will be noted.|baseline to 6 months|All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject||||||
2610542|NCT02054910|Secondary|Mean Quality of Life Score Between Each Group at 6 Months|The American Chronic Pain Association, Quality of Life Score will be used. This scoring ranges from 0 (Stay in bed all day Feel hopeless and helpless about life - non-functioning) to 10 (Go to work/volunteer each day Normal daily activities each day Have a social life outside of work Take an active part in family life - normal life).|6 months post baseline|All subjects were lost to follow up by 6 months; the secondary endpoint was not collected for any subject||||||
2610543|NCT02054910|Primary|Change in Pain Response Over a 6 Month Period of Time Using the VAS Score|Pain scores will be assessed by comparing the mean number change using the Visual Analog Scale (VAS) from baseline to 6 month. The scale is 10 - 0, with 10 being agonizing pain and 0 being no pain.|baseline to 6 months|All subjects were lost to follow up by 6 months; the primary endpoint was not collected for any subject||||||
2610544|NCT02054897|Secondary|Subjects Who Achieve (Yes/no):HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target|Percentage of subjects who achieve (yes/no): HbA1c below 6.5% (48 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|At 30 weeks of treatment|Full analysis set|||Percentage of subjects|||Number
2610545|NCT02054897|Secondary|Subjects Who Achieve (Yes/no):HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association Target|Percentage of subjects who achieve (yes/no): HbA1c below 7.0% (53 mmol/mol) American Diabetes Association target after 30 weeks' treatment. Missing HbA1c data imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|At 30 weeks of treatment|Full analysis set|||Percentage of subjects|||Number
2610546|NCT02054897|Secondary|Change in Systolic and Diastolic Blood Pressure|Change from baseline (week 0) in systolic and diastolic blood pressure was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 30|Full analysis set|||mmHg||Standard Deviation|Mean
2610590|NCT02054520|Secondary|Immune Activation|To further determine whether the humoral and cellular mediated arms of the host immune system are activated secondary to dorgenmeltucel-L immunotherapy combined with immune checkpoint inhibition.|2 years|||||||
2610548|NCT02054897|Secondary|Change in Body Weight|Change from baseline (week 0) in body weight was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 30|Full analysis set|||kilogram(s)||Standard Deviation|Mean
2610549|NCT02054897|Primary|Change in HbA1c (Glycosylated Haemoglobin)|Change from baseline (week 0) in HbA1c was evaluated after 30 weeks of treatment. Missing data were imputed from a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.|Week 0, week 30|Full analysis set|||Percentage of HbA1c||Standard Deviation|Mean
2610550|NCT02054754|Other Pre-specified|Pharmacodynamic Biomarker Assessment|Blood samples taken and analysed for the purposes of the identification and quantification of pharmacodynamic biomarkers pre-dose and at several points after dosing.|Pre-dose, 1, 6 and 24 hours post dose|||||||
2610551|NCT02054754|Secondary|Area Under the Curve of the Compound Dexanabinol (ETS2101) From Pre-dose up to 48 Hours Post Dose|Pharmacokinetic parameters will be assessed in a blinded fashion at the end of each cohort, prior to dose escalation.|Pre-dose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16,24,36,48 hours post dose||||ng.h/mL||Standard Deviation|Mean
2610552|NCT02054754|Primary|Safety and Tolerability Based on the Number of Participants With Adverse Events and Comparison of Baseline and Post Dose Parameters|"Safety and tolerability based on the number of participants with adverse events. Assessment and comparison to baseline of the following:~Physical exam~Safety bloods and urinalysis~12-lead ECG~Vital signs"|Participants will be followed until follow up visit, 6-11 days after dosing||||participants|||Number
2610553|NCT02054715|Other Pre-specified|To Explore the Effects of Intervention Assignment on Clinical Trial Participation.|Given the ethical perspective that patients have a right to make autonomous decisions about clinical trial participation, no hypothesis is offered about the effect of intervention assignment on clinical trial participation rates. To conduct the exploratory analysis regarding the effects of intervention assignment on clinical trial participation, data for all patients offered participation in a therapeutic clinical trial will be entered into a 2 (Intervention: MP or PE) x 2 (Clinical Trial Participation: Yes or No/Still Deciding) contingency table and analyzed using either a Fisher exact test or chi-square test as appropriate.|Day 49-56|The population for this outcome is 192 (PE) + 170 (MP) = 362 Note: There were 3 individuals (MP) who did not answer this question. This is defined as follow-up 2 (Day 49-56).|||Participants|||Count of Participants
2610554|NCT02054715|Secondary|The Decisional Conflict Scale (DCS)|The Decisional Conflict Scale (DCS) is a valid and reliable 16-item self-report measure that assesses the extent to which respondents experience certainty, satisfaction, and confidence following a health care decision. In the present study, it will be keyed to the decision about therapeutic clinical trial participation. Instructions given to respondents include asking them to reflect on the decisions have just made or are about to make and to respond to statements in the DCS using a five-point Likert scale. Responses to each statement are scored from 1 (strongly agree) to 5 (strongly disagree), with negative statements having reverse scoring; thus high scores indicate higher decisional conflict.|Day 49-56|The population for this outcome is 192 (PE) + 173 (MP) = 365 This is defined as follow-up 2 (Day 49-56).|||Percentage of DCS (0 - 100)||Standard Error|Mean
2610555|NCT02054715|Secondary|The Decision Regret Scale (DRS)|The Decision Regret Scale (DRS) is a five-item paper and pencil self-report measure that asks subjects to reflect on a particular decision and then rate each item on a Likert scale from 1 (strongly agree) to 5 (strongly disagree). A mean score for the DRS is calculated by reverse scoring the two negatively phrased items and dividing by five. The mean scores are converted to a score ranging from 0 to 100 by subtracting 1 and multiplying by 25 and higher scores represent increases in the severity of decision regret. Higher scores are worse.|Day 49-56|The population for this outcome is 192 (PE) + 173 (MP) = 365 This is defined as follow-up 2 (Day 49-56).|||percentage of DRS (0 - 100)||Standard Error|Mean
2610556|NCT02054715|Primary|Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale|Preparation for Decision Making Scale (PDMS) is a valid and reliable 10-item self-report measure for which respondents rate the usefulness of materials they were provided in preparing them to communicate with their health care provider and make a health care decision. Each item is scored 1 to 5 where 1=Not at All, 2=A Little, 3=Somewhat, 4=Quite a Bit, 5=A Great Deal. Larger number is better. All 10 scores are summed, then divided by 10; The result - 1 is then multiplied by 25 and we have a range from 0 (less prepared) - 100 (most prepared).|Day 3 to 7|There were 219 (PE) + 199 (MP) = 418 at Baseline. The population for this outcome is 211 (PE) + 192 (MP) = 403 This is defined as follow-up 1 (Day 3-7).|||percentage of PDMS (0 - 100)||Standard Error|Mean
2610557|NCT02054702|Secondary|Change From Baseline to Week 6 in Barratt Impulsiveness Scale (BIS-11 Item) Total Score|The BIS-11, a subject-rated scale designed to assess impulsive personality traits, was administered at the baseline and Week 6 visits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, nonplanning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, higher scores indicate better personality trait.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2610558|NCT02054702|Secondary|Change From Baseline to Week 6 in Specific Levels of Functioning Scale (SLOF) Total Score|"The SLOF questionnaire used in this trial consisted of 30 items grouped into 4 areas: interpersonal relationships, social acceptability, activities, and work skill. The SLOF correlates with a subject's quality of life. Each of the questions in the domains is rated on a 5-point Likert scale ranging from 1 not well at all to 5 very well. The possible total score range for SLOF is from 30 to 150, higher score indicating better overall functioning of the participant."|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2610591|NCT02054520|Secondary|Anti-tumor Immune Response|To measure anti-tumor immune responses in melanoma metastases in responding and non-responding patients.|2 years|||||||
2610559|NCT02054702|Secondary|Response Rate by Study Week|The response rate was defined as reduction of ≥30% from Baseline in PANSS Total Score or CGI-I score of of 1 (very much improved) or 2 (much improved).|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.|||percentage of participants|||Number
2610560|NCT02054702|Secondary|Mean Change in Clinical Global Impression-Improvement (CGI-I) Score at Week 6|The efficacy of trial medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at Baseline prior to the first dose of double-blind study medication. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. Analysis was performed on the LOCF dataset.|||Units on a scale||Standard Deviation|Mean
2610561|NCT02054702|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score|"The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.|||Units on a scale||Standard Error|Least Squares Mean
2610562|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Scores of One Card Learning Task|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.|||z-score||Standard Error|Least Squares Mean
2610563|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Scores of Identification Task|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.|||z-score||Standard Error|Least Squares Mean
2610564|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Scores of Detection Task|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.|||z-score||Standard Error|Least Squares Mean
2610565|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Scores of Groton Maze Learning (GML)|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment.|||z-score||Standard Error|Least Squares Mean
2610566|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery of Early Phase Battery Score|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement. The cognitive test early phase battery was analyzed; tasks included Groton Maze Learning Task, Detection Task, Identification Task, and One Card Learning Task.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.|||z-score||Standard Error|Least Squares Mean
2610567|NCT02054702|Secondary|Change From Baseline in Cognitive Test Battery Composite Score|The cognitive test battery contains 8-tasks, including the Detection Task (DET, speed of processing), Identification Task (IDN, attention/vigilance), One Card Learning Task (OCL, visual learning), One-back Memory Task (ONB, working memory), Two Back Task (TWOB, working memory), the Groton Maze Learning Task (GML, problem solving/error monitoring), Social Emotional Cognition Task (SECT, social cognition), International shopping List Task (ISL, verbal learning and memory). The results of each domain on the cognitive test battery were calculated into Z-scores, where the healthy control mean was set to zero and the standard deviation to 1. A composite score was generated, with higher values representing better cognitive performance. The composite score is then the mean of z-scores for appropriate tasks where z-score = − 1 × z-score for DET, GML, IDN and ONB to correct for the direction of improvement.|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a MMRM analysis with an unstructured variance covariance structure.|||z-score||Standard Error|Least Squares Mean
2610568|NCT02054702|Primary|Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 6|All randomized participants who took at least one dose of study medication and who had a valid Baseline assessment and at least 1 valid Post-Baseline efficacy assessment. The efficacy analyses were performed by fitting a mixed model repeated measures (MMRM) analysis with an unstructured variance covariance structure.|||Units on a scale||Standard Error|Least Squares Mean
2610569|NCT02054572|Secondary|Number of Participants With Anti-etelcalcetide Antibodies|The presence of anti-etelcalcetide antibodies was assessed and confirmed using a dual-flow cell biosensor immunoassay at baseline (day -1) and at the end of study visit (day 39).|Day -1 and day 39|Participants who received any amount of [¹⁴C]etalcalcetide|||participants|||Number
2610570|NCT02054572|Secondary|Number of Participants With Adverse Events|A treatment-related adverse event (TRAE) is any adverse event (AE) that per investigator review has a reasonable possibility of being caused by the investigational product.|From first dose of etelcalcetide to day 39|Participants who received any amount of [¹⁴C]etalcalcetide|||participants|||Number
2610571|NCT02054572|Secondary|Hemodialysis Extraction Ratio for Etelcalcetide During Hemodialysis on Day 4||Day 4 within 10 minutes after the start of hemodialysis, at 2 hours after the start of hemodialysis, and within 10 minutes before the end of hemodialysis.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||ratio||Standard Deviation|Mean
2610572|NCT02054572|Secondary|Hemodialysis Clearance of Etelcalcetide During Hemodialysis on Day 4||Day 4 within 10 minutes after the start of hemodialysis, at 2 hours after the start of hemodialysis, and within 10 minutes before the end of hemodialysis.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||mL/hr||Standard Deviation|Mean
2610573|NCT02054572|Secondary|Area Under the Curve From Time Zero to 10 Days Post-dose (AUC10d) of Etelcalcetide||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||day*ng/mL||Standard Deviation|Mean
2610574|NCT02054572|Secondary|Area Under the Curve From Time Zero to 3 Days Post-dose (AUC3d) of Etelcalcetide||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||day*ng/mL||Standard Deviation|Mean
2610575|NCT02054572|Secondary|Last Observed Plasma Concentration (Clast) of Etelcalcetide||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||ng/mL||Full Range|Median
2610576|NCT02054572|Secondary|Time to Last Observed Plasma Concentration of Etelcalcetide||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||days||Full Range|Median
2610577|NCT02054572|Secondary|Maximum Observed Concentration (Cmax) of Etelcalcetide||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||ng/mL||Standard Deviation|Mean
2610578|NCT02054572|Secondary|Time to Maximum Observed Concentration (Tmax) of Etelcalcetide|Etelcalcetide plasma concentrations were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS).|Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||minutes||Full Range|Median
2610579|NCT02054572|Primary|Area Under the Venous Plasma Concentration-time Curve Obtained During Hemodialysis on Day 4 for Etelcalcetide|Etelcalcetide plasma concentrations were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS).|Day 4 within 10 minutes after the start of hemodialysis, at 2 hours after the start of hemodialysis, and within 10 minutes before the end of hemodialysis.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||ng*day/mL||Standard Deviation|Mean
2610580|NCT02054572|Primary|Area Under the Arterial Plasma Concentration-time Curve Obtained During Hemodialysis on Day 4 for Etelcalcetide|Etelcalcetide plasma concentrations were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS).|Day 4 within 10 minutes after the start of hemodialysis, at 2 hours after the start of hemodialysis, and within 10 minutes before the end of hemodialysis.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||ng*day/mL||Standard Deviation|Mean
2610581|NCT02054572|Primary|Area Under the Curve From Time Zero to 10 Days Post-dose (AUC10d) of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||day*ng-eq/mL||Standard Deviation|Mean
2610582|NCT02054572|Primary|Area Under the Curve From Time Zero to 3 Days Post-dose (AUC3d) of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||day*ng-eq/mL||Standard Deviation|Mean
2610583|NCT02054572|Primary|Apparent Terminal Half-life (T½) of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||days||Standard Deviation|Mean
2610584|NCT02054572|Primary|Last Observed Plasma Concentration (Clast) of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||ng-eq/mL||Full Range|Median
2610585|NCT02054572|Primary|Time to Last Observed Plasma Concentration of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||days||Full Range|Median
2610586|NCT02054572|Primary|Maximum Observed Concentration (Cmax) of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma||Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||ng-eq/mL||Standard Deviation|Mean
2610587|NCT02054572|Primary|Time to Maximum Observed Concentration (Tmax) of [¹⁴C]Etelcalcetide-derived Radioactivity in Plasma|Total radioactive counts in plasma was determined by accelerator mass spectrometry (AMS).|Samples were collected from pre-dose on day 1 to day 39; additional samples were collected at 3 consecutive hemodialysis sessions from days 129 -148 and approximately 1 month later at an additional 3 consecutive hemodialysis sessions from days 157-176.|Participants who received any part of the [¹⁴C]etelcalcetide dose and had measurable concentrations in at least 1 sample were included in the analysis.|||minutes||Full Range|Median
2610588|NCT02054572|Primary|Cumulative Excretion of Radioactivity|The total radioactivity in excreta (urine and feces) or dialysate and dialysis membrane is expressed as a percentage of the total radioactive [¹⁴C] administered (dose). Total radioactive counts in dialysate, dialyzer, feces, and urine were determined by accelerator mass spectrometry (AMS). Radioactivity excreted during non-sampled days was estimated by interpolation and extrapolation of the measured data.|Day 1 to day 176|Participants who received any amount of [¹⁴C]etelcalcetide with available excretion data|||Percentage of administered dose||Standard Deviation|Mean
2610589|NCT02054520|Secondary|Anti-Tumor Mechanism|To perform correlative studies of patient samples (blood and tumor when available) to determine the mechanism of any observed anti-tumor effect.|2 years|||||||
2610907|NCT02047500|Primary|Number of Subjects Experiencing Dose Limiting Toxicity (DLT)||Up to Day 28 of Cycle 1|One patient not evaluable as they did not complete cycle 1|||Participants|||Count of Participants
2610592|NCT02054520|Secondary|Clinical Activity|To estimate the disease-free survival (DFS), progression-free survival (PFS), overall survival (OS) and duration of overall response, duration of complete response (CR) and duration of stable disease (SD) of patients with stage IV melanoma treated with immune checkpoint inhibition with or without dorgenmeltucel-L immunotherapy.|2 years|||||||
2610593|NCT02054520|Primary|Clinical Response Rate|To estimate the clinical response rate of metastatic melanoma patients after immunotherapy with dorgenmeltucel-L immunotherapy plus immune checkpoint inhibition|2 years|The enrollment and treatment phase of this trial was terminated early, but the FDA required 15 year long term follow-up for gene therapy is still ongoing. The analysis of clinical response rate was limited as enrollment to the trial was closed early.|||Participants|||Count of Participants
2610594|NCT02054520|Primary|Safety and Tolerability Assessed by Development of AEs and Laboratory Parameters|To determine the safety of administration of immune checkpoint inhibition consisting of ipilimumab, nivolumab, or pembrolizumab with or without dorgenmeltucel-L immunotherapy for patients with stage IV melanoma|2 years|The primary population for safety analyses is the safety analysis set, defined as all randomized subjects who receive at least one administration of study treatment (dorgenmeltucel-L or immune checkpoint therapy).|||participants with event|||Number
2610595|NCT02054481|Secondary|Time to Loss of PASI50 Response|Time to loss of PASI50 response.|From first drug administration until end of follow-up period, up to 48 weeks|FAS|||Days||95% Confidence Interval|Median
2610596|NCT02054481|Secondary|Achievement of sPGA Clear or Almost Clear at Week 12|"Percentage of participants who achieved static Physician Global Assessment (sPGA) clear or almost clear at Week 12.~sPGA is assessed on a six-point scale from 0 (clear) to 5 (severe)."|Week 12|FAS|||Percentage of participants||95% Confidence Interval|Number
2610597|NCT02054481|Secondary|Percentage Change in PASI Score From Baseline at Week 12|"Percentage change in Psoriasis Area and Severity Index (PASI) from baseline at Week 12.~PASI score ranges from 0 (best) to 72 (worst)."|Baseline and Week 12|FAS including patients with available data.|||Percentage of PASI score||Standard Deviation|Mean
2610598|NCT02054481|Secondary|Achievement of PASI90 at Week 24|"Percentage of participants who achieved PASI90 at Week 24.~PASI score ranges from 0 (best) to 72 (worst)."|Week 24|FAS|||Percentage of participants||95% Confidence Interval|Number
2610599|NCT02054481|Secondary|Achievement of ≥50% Reduction From Baseline in PASI Score (PASI50) at Week 12|"Percentage of participants who achieved ≥50% reduction from baseline in Psoriasis Area and Severity Index score (PASI50) at Week 12.~PASI score ranges from 0 (best) to 72 (worst)."|Baseline and Week 12|FAS|||Percentage of participants||95% Confidence Interval|Number
2610600|NCT02054481|Secondary|Achievement of 100% Reduction From Baseline in PASI Score (PASI100) at Week 12|"Percentage of participants who achieved 100% reduction from baseline in Psoriasis Area and Severity Index score (PASI100) at Week 12.~PASI score ranges from 0 (best) to 72 (worst)."|Baseline and Week 12|FAS|||Percentage of participants||95% Confidence Interval|Number
2610601|NCT02054481|Secondary|Achievement of ≥75% Reduction From Baseline in PASI Score (PASI75) at Weeks 12 and 24|"Percentage of participants who achieved ≥75% reduction from baseline in Psoriasis Area and Severity Index score (PASI75) at Weeks 12 and 24.~PASI score ranges from 0 (best) to 72 (worst)."|Baseline, Week 12 and Week 24|FAS|||Percentage of participants||95% Confidence Interval|Number
2610602|NCT02054481|Primary|Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12|"Percentage of participants who achieved ≥90% reduction from baseline in Psoriasis Area and Severity Index score (PASI90) at Week 12.~PASI score ranges from 0 (best) to 72 (worst)."|Baseline and Week 12|Full Analysis Set (FAS) which included all randomised patients who received at least 1 dose of trial medication and was based on the randomised treatment.|||Percentage of participants||95% Confidence Interval|Number
2610603|NCT02054338|Secondary|Overall Response Rate & Disease Control Rate|Disease control rate (DCR) is defined as the sum of Complete Response (CR) and Partial Response (PR) and Stable Disease (SD) ≥ 6 months rate. Objective response rate (ORR) is defined as the sum of Complete Response (CR) and Partial Response (PR) rate (using the best confirmed response recorded from the date of randomisation to the end of treatment). DCR and ORR, assessed by Independent Review Committee using RECIST 1.0, were calculated in the ITT population.|ORR and DCR were calculated from the date of randomisation of first patient until the database cut-off (30 June 2011), assessed up to 5 years|ITT|||percentage of patients||95% Confidence Interval|Median
2610604|NCT02054338|Secondary|Overall Survival|The secondary efficacy parameter was Overall Survival (OS) analysed in the Intent-to-treat (ITT) population. OS was defined as the time elapsed from the date of randomisation up to death or last follow-up.|OS was evaluated from the date of registration to the date of death due to any cause (median duration of follow-up: 14.1 months)|ITT population - Cut-off date: 30 June 2011|||Months||95% Confidence Interval|Median
2610605|NCT02054338|Primary|Progression Free Survival|The primary efficacy parameter was Progression-free survival (PFS) analysed in the Intent-to-treat (ITT) population. PFS was defined as the time elapsed from randomisation date until the date of progression or death due to any cause (whichever came first).Tumor response was evaluated using the RECIST version 1.0 every 6 weeks until progression was recorded.|PFS was calculated from the registration date until the date of progression or death due to any cause if no progression was recorded first (median duration of follow-up: 14.1 months)|ITT population|||Months||95% Confidence Interval|Median
2610606|NCT02054325|Secondary|The Safety of the Treatment: Mean Percent of Skin Hyperpigmentation Two Months After Treatment|"Skin hyperpigmentation was defined as a brownish hue stain superimposing the previous treated vein site (by visual photographic analyses). Skin hyperpigmentation was firstly evaluated according to its occurence and labeled as Yes or No. Afterwards, when there was stain in the previous treated area, a line was drawn on the stain with Image J software , and the Mean Percent of Skin Hyperpigmentation was proportionaly compared with length of vein treated, previuos mesuread (mean and SD)."|Two months after treatment.||||Percent of Skin Hyperpigmentation||Standard Deviation|Mean
2610607|NCT02054325|Primary|Efficacy in Treating Reticular Veins by Photographs: Mean Percent Reticular Vein Disappearance Two Months After Treatment.|Photographs were performed pretreatment and two months after the treatment, these were analyzed for efficacy in treat reticular veins by two blind analyzers objectively with measurement through the use of free software ImageJ.|Mean Percent of reticular vein disappearance two months after treatment||||% of Reticular Veins that Disappeared||Standard Deviation|Mean
2610612|NCT02054130|Secondary|Number of Participants With Positive Antibodies to MEDI9929|Blood samples for immunogenicity assessment included the determination of anti-drug antibodies (ADA) for MEDI9929. The number of participants with positive serum antibodies to MEDI9929 were presented.|Week 0 (Day 1) to Week 64|"As-treated population included all participants who received any study drug. Here, N signifies number of participants analyzed for this outcome measure."|||Participants|||Count of Participants
2610613|NCT02054130|Secondary|Mean Serum Concentrations of MEDI9929|The mean serum concentrations of MEDI9929 was observed at specified timepoints.|Week 0 (Day 1) to Week 64|"Pharmacokinetic population included all participants who received MEDI9929 and have a sufficient number of serum concentration measurements. Here, N signifies number of participants analyzed for this outcome measure."|||ng/mL||Standard Deviation|Mean
2610614|NCT02054130|Secondary|Number of Participants With TEAEs Related to Electrocardiogram Evaluations|Adverse events observed in participants with clinically significant electrocardiogram abnormalities were assessed.|From the start of study drug administration upto Week 64|As-treated population included all participants who received any study drug.|||Participants|||Count of Participants
2610615|NCT02054130|Secondary|Number of Participants With TEAEs Related to Clinical Laboratory Evaluation|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Laboratory evaluations of blood and urine samples were performed.|Day 1 upto Week 64|As-treated population included all participants who received any study drug.|||Participants|||Count of Participants
2610616|NCT02054130|Secondary|Number of Participants With TEAEs Related to Vital Sign Parameters|Adverse events observed in participants with clinically significant vital signs abnormalities were assessed.|Day 1 upto Week 64|As-treated population included all participants who received any study drug.|||Participants|||Count of Participants
2610617|NCT02054130|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any adverse event that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period until and including the follow-up period (Week 64).|Day 1 upto Week 64|As-treated population included all participants who received any study drug.|||Participants|||Count of Participants
2610618|NCT02054130|Secondary|Total Amount of Study Drug Exposure|The total amount of study drug exposure (in milligram) for the entire study period was summarized.|Week 0 (Day 1) through Week 52|As-treated population included all participants who received any study drug.|||Milligram||Standard Deviation|Mean
2610619|NCT02054130|Secondary|Change From Baseline in European Quality of Life-5 Dimensions 5 Level Version (EQ-5D-5L) Health State Evaluation at Week 52|European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1. A higher score indicates better health state. The second component is a self-perceived health score which is assessed using a visual analogue scale (VAS) that ranged from 0 to 100, where 0 indicated the worst health you can imagine and 100 indicated the best health you can imagine.|Baseline (Week 0 [Day 1]) and Week 52|"Intent-to-treat population included participants who are randomized and received any study drug. Here, N signifies number of participants analyzed for this outcome measure."|||Units on a scale||Standard Deviation|Mean
2610620|NCT02054130|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ [S]) Overall Score at Week 52|The AQLQ(S) +12 is a 32-item questionnaire that measures the health-related quality of life experienced by asthma participants. The questionnaire comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli) scaled on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment).|Baseline (Week 0 [Day 1]) and Week 52|Intent-to-treat population included participants who are randomized and received any study drug.|||Units on a scale||Standard Deviation|Mean
2610621|NCT02054130|Secondary|Number of Participants With at Least One Severe Asthma Exacerbations Through Week 52|Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Participants with severe asthma exacerbations (hospitalization) were reported.|Week 0 (Day 1) through Week 52|Intent-to-treat population included participants who are randomized and received any study drug.|||Participants|||Count of Participants
2610622|NCT02054130|Secondary|Number of Participants With at Least One Asthma Exacerbations Through Week 52|Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma.|Week 0 (Day 1) through Week 52|Intent-to-treat population included participants who are randomized and received any study drug.|||Participants|||Count of Participants
2610623|NCT02054130|Secondary|Time to First Severe Asthma Exacerbation Through Week 52|Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Time to first severe asthma exacerbations (hospitalization) were reported.|Week 0 (Day 1) through Week 52|Intent-to-treat population included participants who are randomized and received any study drug.|||Days||95% Confidence Interval|Median
2610908|NCT02047344|Other Pre-specified|Overall Survival|the time from the date of first administration of study drug to death from any cause|up to week 48||||percentage of participants||95% Confidence Interval|Number
2610624|NCT02054130|Secondary|Time to First Asthma Exacerbation Through Week 52|Asthma exacerbation is defined as worsening of asthma that leads to use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Time to first asthma exacerbation was reported.|Week 0 (Day 1) through Week 52|Intent-to-treat population included participants who are randomized and received any study drug.|||Days||95% Confidence Interval|Median
2610625|NCT02054130|Secondary|Rate of Severe Asthma Exacerbation Through Week 52|A severe asthma exacerbation is defined as an event that resulted in hospitalization. The severe AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.|Week 0 (Day 1) up to Week 52|Intent-to-treat population included participants who are randomized and received any study drug.|||events per person-year||95% Confidence Interval|Number
2610626|NCT02054130|Secondary|Change From Baseline in Asthma Symptoms Measured by Asthma Control Questionnaire (ACQ-6) Score at Week 52|The ACQ is a patient-reported questionnaire assessing asthma symptoms (ie, night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use and FEV1. The ACQ-6 is a shortened version of the ACQ that omits the FEV1 measurement from the original ACQ score. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled).|Baseline (Week 0 [Day 1]) and Week 52|Intent-to-treat population included participants who are randomized and received any study drug.|||Units on a scale||Standard Deviation|Mean
2610627|NCT02054130|Secondary|Change From Baseline in Asthma Symptoms Measured by Asthma Daily Diary at Week 52|Asthma symptoms during night time and daytime are recorded by the participant in the asthma daily diary. Symptom score values for night time assessment is 0 (no asthma symptom) to 3 (unable to sleep because of asthma) and symptom score values for day time assessment is 0 (no asthma symptom) to 3 (unable to do normal activities due to asthma). Total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom.|Baseline (Week 0 [Day 1]) and Week 52|"Intent-to-treat population included participants who are randomized and received any study drug. Here, N signifies number of participants analyzed for this outcome measure."|||Units on a scale||Standard Deviation|Mean
2610628|NCT02054130|Secondary|Change From Baseline in Overall Symptoms Score on Subpopulations at Week 52|Asthma symptoms during night time and daytime are recorded by the participant in the asthma daily diary. Overall symptom score is the average of scores of daytime severity, daytime frequency, and nighttime severity symptoms. The daytime frequency and severity items are scored from 0 to 4, where a higher score indicates greater frequency/severity and nighttime severity item is scored from 0 to 4 , where a higher score indicates greater severity. Overall symptom score ranges from 0 to 4, where lower score indicates better asthma symptom while, higher score indicates worse asthma symptom.|Baseline and up to Week 52|"Intent-to-treat population included participants who are randomized and received any study drug. Here, N signifies number of participants analyzed for this outcome measure."|||Units on a scale||Standard Error|Least Squares Mean
2610629|NCT02054130|Secondary|Change From Baseline in Post-bronchodilator (Post-BD) FEV1 and FVC at Week 52|Forced expiratory volume in 1 second and forced vital capacity measures taken after bronchodilator use were reported.|Baseline (Week 0 [Day 1]) to Week 52|"Intent-to-treat population included participants who are randomized and received any study drug. Here, N signifies number of participants analyzed for this outcome measure."|||Liter||Standard Deviation|Mean
2610630|NCT02054130|Secondary|Change From Baseline in FEV1 on Subpopulations at Week 52|Forced expiratory volume in one second (FEV1) was evaluated in pre-specified subpopulations of asthma. The data presented in the below table for this outcome measure is for pre-bronchodilator FEV1.|Baseline and up to Week 52|"Intent-to-treat population included participants who are randomized and received any study drug. Here, N signifies number of participants analyzed for this outcome measure."|||Liters||Standard Error|Least Squares Mean
2610631|NCT02054130|Secondary|Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Week 52|Forced expiratory volume in 1 second and forced vital capacity measures taken before bronchodilator use were reported.|Baseline (Week 0 [Day 1]) to Week 52|"Intent-to-treat population included participants who are randomized and received any study drug. Here, N signifies number of participants analyzed for this outcome measure."|||Liter||Standard Deviation|Mean
2610632|NCT02054130|Secondary|Reduction in AER on Subpopulations at Week 52|Asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. Reduction in AER was evaluated in pre-specified subpopulations (blood eosinophil count [eosinophilic and non-eosinophilic], T helper cell 2 [Th2] status [high and low], Fraction of exhaled nitric oxide [FENO] [high and low], serum periostin [high and low], current post bronchodilator forced expiratory volume in 1 second [Post-BD FEV1] reversibility- yes, allergic and non-allergic) of asthma. The annual AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up. Also, the high or low was determined using median value.|Week 52|"Intent-to-treat population included participants who are randomized and received any study drug. Here, N signifies number of participants analyzed for this outcome measure."|||events per person-year||95% Confidence Interval|Number
2610633|NCT02054130|Primary|Annualized Asthma Exacerbation Rate (AER) Through Week 52|Asthma exacerbation is defined as worsening of asthma that leads to any of the following: use of systemic corticosteroids for at least 3 days, an emergency department visit due to asthma that required systemic corticosteroids, and an inpatient hospitalization due to asthma. The annual AER was presented as the total number of exacerbations for the treatment group divided by the total duration of person follow-up.|Week 0 (Day 1) up to Week 52|Intent-to-treat population included all participants who are randomized and received any study drug.|||events per person-year||95% Confidence Interval|Number
2610634|NCT02053753|Secondary|Number of Participants Who Developed Anti-denosumab Antibodies||Predose on day 1, and days 29, 67 and 127|All participants who received denosumab|||participants|||Number
2610635|NCT02053753|Secondary|Number of Participants With Adverse Events|A treatment-related adverse event (TRAE) is any treatment-emergent adverse event (AE) that per investigator review has a reasonable possibility of being caused by the investigational product.|From the first dose of denosumab through day 126|All participants who received denosumab|||participants|||Number
2610636|NCT02053753|Secondary|Time to Reach Maximum Percent Inhibition (Tmax) of Serum CTX1|Serum CTX1 concentration-time data were analyzed by non-compartmental methods. Serum CTX1 concentrations below the LLOQ (0.0490 ng/mL) were set to 0.0490 ng/mL before data analysis.|Day 1 predose up to day 127|The pharmacodynamic analysis set includes all participants who received denosumab and had at least one sCTX1 sample collected.|||days||Full Range|Median
2610637|NCT02053753|Secondary|Maximum Percent Inhibition (Imax) of Serum CTX1|Serum CTX1 concentration-time data were analyzed by non-compartmental methods. Serum CTX1 concentrations below the LLOQ (0.0490 ng/mL) were set to 0.0490 ng/mL before data analysis.|Day 1 predose up to day 127|The pharmacodynamic analysis set includes all participants who received denosumab and had at least one sCTX1 sample collected.|||percent inhibition||Standard Deviation|Mean
2610638|NCT02053753|Secondary|Area Under the Serum C-telopeptide (CTX1) Percent Inhibition-Time Curve From Time 0 to 18 Weeks Post-dose (AUEC0-18 Weeks)|"Serum CTX1 concentration-time data were analyzed by non-compartmental methods. Serum CTX1 concentrations below the LLOQ (0.0490 ng/mL) were set to 0.0490 ng/mL before data analysis.~AUEC0-18 weeks was estimated using the linear-log trapezoidal method."|Day 1 predose up to day 127|"The pharmacodynamic (PD) analysis set includes all participants who received denosumab and had at least one sCTX1 sample collected.~Eleven participants were excluded from the analysis of AUEC0-18 weeks because no samples after week 16 were collected."|||day*percent inhibition||Standard Deviation|Mean
2610639|NCT02053753|Secondary|Half-life (T1/2) of Denosumab|Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.|Day 1 predose up to day 127|The PK concentration analysis set; 2 participants were excluded from all PK analyses because insufficient samples were available for calculation of PK variables and a further 11 participants were excluded from the analysis of T1/2 because all samples after week 16 were missing.|||days||Standard Deviation|Mean
2610640|NCT02053753|Secondary|Time to Maximum Observed Concentration (Tmax) of Denosumab|Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.|Day 1 predose up to day 127|The pharmacokinetic (PK) concentration analysis set includes all participants who received denosumab and had at least one PK sample collected. Two participants were excluded from all PK analyses because insufficient samples were available (≥ 3 missing consecutive samples) for calculation of PK variables.|||days||Full Range|Median
2610641|NCT02053753|Primary|Area Under the Drug Concentration-time Curve From Time 0 to 18 Weeks Post-dose (AUC0-18 Weeks) of Denosumab|Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.|Day 1 predose up to day 127|The PK concentration analysis set; 2 participants were excluded from all PK analyses because insufficient samples were available for calculation of PK variables and a further 11 participants were excluded from the analysis of AUC0-18 weeks because all samples after week 16 were missing.|||day*μg/mL||Standard Deviation|Mean
2610642|NCT02053753|Primary|Maximum Observed Drug Concentration (Cmax) of Denosumab|Serum denosumab concentration-time data were analyzed by non-compartmental methods. Serum concentrations below the LLOQ (20.0 ng/mL) were set to 0 before data analysis.|Day 1 predose up to day 127|The pharmacokinetic (PK) concentration analysis set includes all participants who received denosumab and had at least one PK sample collected. Two participants were excluded from all PK analyses because insufficient samples were available (≥ 3 missing consecutive samples) for calculation of PK variables.|||μg/mL||Standard Deviation|Mean
2610643|NCT02053610|Secondary|European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire|EORTC Quality of Life Questionnaire (QLQ-CLL16) module was used to assess patient-reported outcomes and symptom burden. The QLQ-CLL16 module includes three multi-item scales assessing fatigue (2 items), treatment side effects and disease symptoms (8 items), infection (4 items) and two single item scales on social activities and future health worries. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.|Baseline and Cycle 4 Day 1 (Cy4D1)|ITT population. Here, n signifies the number of participants who were evaluated for specified category.|||unit on a scale||Standard Deviation|Mean
2610644|NCT02053610|Secondary|European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire|The EORTC Quality of Life Questionnaire (QLQ-C30) was used to assess patient-reported outcomes (PRO) and symptom burden. The QLQ-C30 contains 30 items including the functional scales of physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items) and symptom scales including fatigue (3 items), nausea and vomiting (2 items), and pain (4 items) and six single item scales on dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.|Baseline and Cycle 4 Day 1 (Cy4D1)|ITT population. Here, n signifies the number of participants who were evaluated for specified category.|||unit on a scale||Standard Deviation|Mean
2610645|NCT02053610|Secondary|Time to Re-Treatment/New Anti-leukemic Therapy|Time to re-treatment/new anti-leukemic therapy was defined as time between the date of randomization and the date of first intake of re-treatment or new anti-leukemic therapy.|Randomization to clinical cutoff (median observation 59.4 months)|ITT population included all randomized participants. Participants who were reported as not having started re-treatment or new anti−leukemic therapy were censored at the last visit date they were assessed with regard to start of new treatment or the date of death.|||months||95% Confidence Interval|Median
2610664|NCT02053493|Primary|Arbitrary Accelerometry Units (AAU) (Phase II)|To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.|11-12 weeks|Participants with usable data included in the results|||accelerometry units||Standard Deviation|Mean
2610646|NCT02053610|Secondary|Percentage of Participants With Molecular Remission at the End of Treatment|Molecular remission was defined as a minimal residual disease (MRD)-negative result at the end of treatment (assessment that occurred between 56 days and 6 months of last treatment). Molecular remission was assessed for all patients using a blood sample. Additionally, a bone marrow sample was obtained from patients whom the investigator assumed to have a complete response, consistent with the IWCLL guidelines. A combined analysis of blood and bone marrow results was conducted. A patient was considered MRD negative if result was less than 1 chronic lymphocytic leukemia (CLL) cell in 10000 leukocytes (MRD value < 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR).|Randomization to clinical cutoff (median observation 59.4 months)|Participants from the ITT population, all randomized participants, with data available for analysis. Participants who had not reached the 3-month follow-up visit at the time of the clinical cut-off were excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
2610647|NCT02053610|Secondary|Duration of Response|Duration of Response was defined as the date the response [either Complete Response (CR) or Partial Response (PR)] was first recorded until the date of Disease Progression or death due to any cause. Response was assessed according IWCLL guidelines.|Randomization to clinical cutoff (median observation 59.4 months)|Participants from the ITT population, all randomized participants, with response.|||months||95% Confidence Interval|Median
2610648|NCT02053610|Secondary|Overall Survival|Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.|Randomization to clinical cutoff (median observation 59.4 months)|ITT population included all randomized participants. Participants who were not reported as having died at the time of the analysis were censored at the date when they were last known to be alive.|||months||95% Confidence Interval|Median
2610649|NCT02053610|Secondary|Event Free Survival|Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease as per IWCLL criteria required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 59.4 months)|ITT population included all randomized participants. Participants were censored at the date of last tumor assessment. In cases where no tumor assessment is available, participants were censored at the date of randomization plus one day.|||months||95% Confidence Interval|Median
2610650|NCT02053610|Secondary|Percentage of Participants With Best Overall Response|Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi, PR or nodular Partial Response (nPR). CR required all of the following: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff (median observation 59.4 months)|Participants from the ITT population, all randomized participants, with data available for analysis. Participants who had not reached the 3-month follow-up visit at the time of the clinical cut-off were excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
2610651|NCT02053610|Secondary|Percentage of Participants With End of Treatment Response (EOTR)|EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. Complete Response (CR) required: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. Partial Response (PR) required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff (median observation 59.4 months)|Participants from the ITT population, all randomized participants, with data available for analysis. Participants who had not reached the 3-month follow-up visit at the time of the clinical cut-off were excluded from analysis.|||percentage of participants||95% Confidence Interval|Number
2610652|NCT02053610|Secondary|Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data|Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee.|Randomization to clinical cutoff of 09 May 2013 (median observation 18.7 months)|ITT participants included all randomized participants.|||percentage of participants|||Number
2610665|NCT02053493|Secondary|Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase II)|To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. • The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life).Higher values of the overall KCCQ score are considered to be better than lower values.|Week 13|Participants with usable data included in the results|||units on a scale||Standard Deviation|Mean
2610653|NCT02053610|Secondary|Progression Free Survival Based on Independent Review Committee (IRC) Data|PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by Independent Review Committee. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff of 09 May 2013 (median observation 18.7 months)|Intent-to-treat population (ITT) included all randomized participants. Data for patients without disease progression or death was censored at the time of the last response assessment, or, if no response assessments were performed after the baseline visit, at the time of randomization plus one day.|||months||95% Confidence Interval|Median
2610654|NCT02053610|Primary|Percentage of Participants With Progression Free Survival Events|Percentage of Participants with Progression Free Survival Events: progression, relapse, or death.|Randomization to clinical cutoff (median observation 59.4 months)|ITT population included all randomized participants.|||percentage of participants|||Number
2610655|NCT02053610|Primary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 59.4 months)|Intent--to-treat population (ITT) included all randomized participants. Data for patients without disease progression or death was censored at the time of the last response assessment, or, if no response assessments were performed after the baseline visit, at the time of randomization plus one day.|||months||95% Confidence Interval|Median
2610656|NCT02053493|Secondary|Improvement in Daily Activity - Area Under the Curve (Phase II)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Area under the curve (AUC) of arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. Area under the curve is defined as ((7*average acceleromtery units/day during 30 mg) + (7*average acceleromtery units/day during 60 mg) + (14*average acceleromtery units/day during 120 mg))/28|9-12 weeks|Participants with usable data included in the results|||accelerometry units||Standard Deviation|Mean
2610657|NCT02053493|Secondary|Improvement in Daily Activity - Area Under the Curve (Phase I)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Area under the curve (AUC) of arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. Area under the curve is defined as ((7*average acceleromtery units/day during 30 mg) + (7*average acceleromtery units/day during 60 mg) + (14*average acceleromtery units/day during 120 mg))/28|3-6 weeks|Participants with usable data included in the results|||accelerometry units||Standard Deviation|Mean
2610658|NCT02053493|Secondary|Improvement in Daily Activity - Slope of Daily Average (Phase II)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Slope of daily averaged arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.|9-12 weeks|Participants with usable data included in the results|||accelerometry units/day||Standard Deviation|Mean
2610659|NCT02053493|Secondary|Improvement in Daily Activity - Slope of Daily Average (Phase I)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Slope of daily averaged arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.|3-6 weeks|Participants with usable data included in the results|||accelerometry units/day||Standard Deviation|Mean
2610660|NCT02053493|Secondary|Improvement in Daily Activity - Hours Active Per Day (Phase II)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Hours active per day during maximal dose of study drug|11-12 weeks|Participants with usable data included in the results|||Hours/day||Standard Deviation|Mean
2610661|NCT02053493|Secondary|Improvement in Daily Activity - Hours Active Per Day (Phase I)|To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Hours active per day during maximal dose of study drug|5-6 weeks|Participants with usable data included in the results|||Hours/day||Standard Deviation|Mean
2610662|NCT02053493|Secondary|N-terminal Pro-B-type Natriuretic Peptide Level (Phase II)|To evaluate whether isosorbide mononitrate improves natriuretic peptide levels in comparison to placebo|Week 13|Participants with usable data included in the results|||pg/mL||Standard Deviation|Mean
2610663|NCT02053493|Secondary|N-terminal Pro-B-type Natriuretic Peptide Level (Phase I)|To evaluate whether isosorbide mononitrate improves natriuretic peptide levels in comparison to placebo|Week 7|Participants with usable data included in the results|||pg/mL||Standard Deviation|Mean
2610731|NCT02052466|Secondary|Shoulder Strength - Flexion|Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.|At least 24 months after TSA||||pounds||Standard Deviation|Mean
2610666|NCT02053493|Secondary|Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase I)|To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life).|Week 7|Participants with usable data included in the results|||units on a scale||Standard Deviation|Mean
2610667|NCT02053493|Secondary|Borg Score During 6 Minute Walk Test (Phase II)|To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Borg Scale consists of scale range of 0 to 10 (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). Lower values are considered to be better than higher values.|Week 13|Participants with usable data included in the results|||units on a scale||Standard Deviation|Mean
2610668|NCT02053493|Secondary|Borg Score During 6 Minute Walk Test (Phase I)|To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Borg Scale consists of scale range of 0 to 10 (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). Lower values are considered to be better than higher values.|Week 7|Participants with usable data included in the results|||units on a scale||Standard Deviation|Mean
2610669|NCT02053493|Secondary|Patient Preference for Isosorbide Mononitrate Treatment at the End of Study.|Self reported participant preference for study period 1 vs. study period 2.|Week 13|Participants with usable data included in the results|||participants|||Number
2610670|NCT02053493|Secondary|Six Minute Walk Distance (Phase II)|To evaluate whether isosorbide mononitrate (ISMN) improves functional capacity by 6 minute walk distance in comparison to placebo.|Week 13|Participants with usable data included in the results|||meters||Standard Deviation|Mean
2610671|NCT02053493|Secondary|Six Minute Walk Distance (Phase I)|To evaluate whether isosorbide mononitrate (ISMN) improves functional capacity by 6 minute walk distance in comparison to placebo.|Week 7|Participants with usable data included in the results|||meters||Standard Deviation|Mean
2610672|NCT02053493|Primary|Arbitrary Accelerometry Units (AAU) (Phase I)|To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.|5-6 weeks|Participants with usable data included in the results|||accelerometry units||Standard Deviation|Mean
2610673|NCT02053376|Secondary|Change in Carcinoembryonic Antigen (CEA)|The difference between the levels of Carcinoembryonic antigen (CEA) prior to treatment compared to after treatment. ng/ml|At baseline prior to treatment and after all treatment received, up to 4 years.|Patients who received at least one dose of regorafenib.|||ng/ml||90% Confidence Interval|Mean
2610674|NCT02053376|Secondary|Changes in Cancer Antigen 19-9 (CA19-9) Level|The difference between the levels of Cancer antigen 19-9 (CA19-9) prior to treatment compared to after treatment.|At baseline prior to treatment and after all treatment received, up to 4 years|Patients who received at least one dose of regorafenib and for which CA19-9 levels were obtainable.|||mg/dL||Full Range|Median
2610675|NCT02053376|Secondary|Disease Control Rate (DCR)|"Number of patients who achieved Complete Response (CR) + number of patients who achieved Partial Response (PR) + number of patients who achieved Stable Disease (SD) / total number of response-evaluable patients. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study treatment."|Up to 4 years|Patients who received at least one dose of regorafenib and were evaluable for response|||proportion of participants||90% Confidence Interval|Number
2610676|NCT02053376|Secondary|Overall Survival (OS) - Two or More Doses|The length of time from the start of study treatment that patients remained alive.|Up to 4 years|Patients who received two or more doses of regorafenib.|||months||90% Confidence Interval|Median
2610677|NCT02053376|Secondary|Overall Survival (OS)|The length of time from the start of study treatment that patients remained alive.|Up to 4 years|Patients who received at least one dose of regorafenib.|||months||90% Confidence Interval|Median
2610678|NCT02053376|Secondary|Proportion of Participants With Overall Response (OR)|The number of patients who experienced a Partial Response (PR) + the number of patients who experienced a Complete Response (CR) / total number of response-evaluable patients. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Up to 4 years|Patients who received at least one dose of regorafenib and were evaluable for response|||proportion of participants||90% Confidence Interval|Number
2610679|NCT02053376|Primary|Progression-free Survival (PFS) - Two or More Doses|Duration of time from start of treatment to time of progression or death, whichever occurs first. Per RECIST version 1.1, Progressive Disease (PD) is defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|up to 4 years|Patients who received two or more doses of regorafenib.|||months||90% Confidence Interval|Median
2610744|NCT02052141|Secondary|Plasma Concentration of Complement C4|Concentration of Complement C4 in plasma was determined using an automated nephelometric assay.|Pre-dose and 1 h post-dose at Week 1 (Dose 1) and Week 6 (Dose 12); Pre-dose, 1, 2, 4 and 8 h post-dose at Week 12 (Dose 24) of each intervention period|PK set consisted of all pariticipants in the safety set with no major deviations related to investigational product intake and evaluable PK profiles.|||Milligram per liter (mg/L)||Standard Deviation|Mean
2610680|NCT02053376|Primary|Progression-free Survival (PFS)|Duration of time from start of treatment to time of progression or death, whichever occurs first. Per RECIST version 1.1, Progressive Disease (PD) is defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|Up to 4 years|Patients who received at least one dose of regorafenib.|||months||90% Confidence Interval|Median
2610681|NCT02053168|Secondary|Incidence of Seroma||24 Months||||events|||Number
2610682|NCT02053168|Secondary|Number of Related Post-operative Visits Unrelated to Standard of Care||24 Months||||events|||Number
2610683|NCT02053168|Secondary|Number of Study Related Post Operative New Hospital Admissions||24 Months||||events|||Number
2610684|NCT02053168|Secondary|Number of Study Related Post Operative Surgical Procedures||24 Months||||events|||Number
2610685|NCT02053168|Secondary|Length of Hospital Stay|Measured from end of index procedure to hospital discharge|10 Months||||days||Standard Deviation|Mean
2610686|NCT02053168|Secondary|Surgical Procedure Time|Measured from incision to closure (skin to skin).|Duration of index procedure (mean of 242.5 mins)||||minutes||Standard Deviation|Mean
2610687|NCT02053168|Secondary|Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline)|Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields scale scores for each of these seven health domains, and two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline.|Baseline and 24 months postoperative|All participants with non-missing values at both baseline and respective post procedure assessment.|||units on a scale||Standard Deviation|Mean
2610688|NCT02053168|Secondary|Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline)|Short Form (SF)-12 Version 2 is a multipurpose, 12-item health survey that measures seven domains of health: general health, physical functioning, role limitations due to physical health (role-physical), role limitations due to emotional problems (role-emotional), bodily pain, vitality and mental health, and social functioning. It yields two summary measures of physical and mental health: the physical component summary (PCS) and mental component summary (MCS). The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The change was calculated as the mean value at 24 months minus the mean value at baseline.|Baseline and 24 months postoperative|All participants with non-missing values at both baseline and respective post procedure assessment.|||units on a scale||Standard Deviation|Mean
2610689|NCT02053168|Secondary|Carolinas Comfort Scale (CCS) Total Score - Change From Baseline|The Carolinas Comfort Scale is a short, hernia-specific 8-category questionnaire designed to measure patient perception of symptoms and patient satisfaction with a scale from 0 (no symptoms) to 5 (disabling symptoms). The change was calculated as the mean value at 24 months minus the mean value at baseline.|Baseline and 24 months postoperative|All participants with non-missing values at both baseline and respective post procedure assessment.|||units on a scale||Standard Deviation|Mean
2610690|NCT02053168|Secondary|Number of Participants With Device Related Adverse Events|In this study, a device-related adverse event is defined as any undesirable clinical event occurring in the abdominal space including the lower abdominal, inguinal and pubic regions (including the skin), as well as any other undesirable clinical events judged to be related to the study device or surgical procedure regardless of anatomical region.|24 Months||||Participants|||Count of Participants
2610691|NCT02053168|Primary|Number of Participants With Hernia Recurrence|A recurrent hernia was defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan were evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.|1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months||||Participants|||Count of Participants
2610692|NCT02052895|Primary|Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis|For the analysis, plasma presepsin levels on Day 0 were used and Sepsis/SIRS adjudication was made on Day 7 or day of discharge. ROC-AUC of presepsin for discriminating between SIRS and sepsis is compared to that of procalcitonin.|Up to 7 days|Out of 196 Sepsis/SIRS patients, 6 were excluded due to inclusion/exclusion criteria violation and 4 were excluded due to insufficient data for Sepsis/SIRS adjudication|||probability||95% Confidence Interval|Least Squares Mean
2610693|NCT02052752|Secondary|To Assess the Change in Perceptions of the Overall Appearance of Their Skin for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel|The participants were asked to rate the overall appearance of their facial skin as; 1= Very Dissatisfied; 2= Slightly Dissatisfied; 3= Neither Satisfied nor Dissatisfied; 4= Slightly Satisfied; 5= Very Satisfied. The responses were then tabulated.|Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.|||Units on a scale||Standard Deviation|Mean
2610694|NCT02052752|Secondary|To Assess the Change in Facial Skin Clarity for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel|The Skin clarity was measured using the following scale; 0 Very Clear; 1 Clear; 2 Dull; 3 Very Dull; 4 Unclear. The responses were then tabulated|Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.|||Units on a scale||Standard Deviation|Mean
2610755|NCT02051816|Secondary|Ventilator-free Days|Number of days alive and free of mechanical ventilation after endotracheal intubation|28 days||||DAYS||Standard Deviation|Mean
2610695|NCT02052752|Secondary|To Assess the Percentage Change in Acne Lesion Diameter (Size) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.|The Investigator assessed and score each target lesion's diameter (size). Diameter scores were the actual dimensions, i.e. the value in millimeters at the lesion's widest or highest points.|Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.|||Percentage change||Standard Deviation|Mean
2610696|NCT02052752|Secondary|To Assess the Change in Acne Lesion Redness (Erythema) for the 3% BPO Gel Test Product and Positive Control Relative to the Vehicle Gel.|The investigator assessed the erythema of the target lesion according to the following scale and tabulated the responses: 0=none, 1=minimal, 2=mild, 3=-moderate, 4=severe.|Baseline to 2 hours, 4 hours, Day 1, Day 2, and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.|||Units on a scale||Standard Deviation|Mean
2610697|NCT02052752|Secondary|To Assess the Percentage Change in Acne Lesion Swelling (Height) for the 3% Benzoyl Peroxide Gel Test Product and Positive Control Relative to the Vehicle Gel.|The Investigator assessed and score each target lesion's swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion's highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant|Baseline to 2 hours, 4 hours, Day 1, Day 2 and Day 4|The analysis population consists of the ITT population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.|||Percentage change||Standard Deviation|Mean
2610698|NCT02052752|Primary|To Assess the Percentage Change in Acne Lesion Swelling (Height) of the Target Lesion for 3% Benzoyl Peroxide (BPO) Gel Test Product Relative to the Vehicle Gel After 4 Once-daily Applications.|The Investigator assessed and score each target lesion's swelling (elevation), elevation scores were the actual dimensions, i.e. the value in millimeters at the lesion's highest points. Percent change in height of all three target lesions were calculated and averaged for each participant. The average lesion height at baseline was calculated for each participant. An analysis of covariance (ANCOVA) was performed with average percentage change in target lesion height as the response variable, treatment group (3% BPO or vehicle) as a main effect, and average baseline target lesion height as a covariate. A greater reduction in the percentage change in height of the target lesions indicated a better outcome measure|Baseline to Day 4|The analysis population consists of the intent-to-treat (ITT) population. The ITT analysis set comprised of all participants who were randomized and received at least 1 application of study product and had baseline assessment.|||Percentage change||Standard Error|Mean
2610699|NCT02052661|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 1|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subject|||Number
2610700|NCT02052661|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-30) follow-up period after the single challenge dose of Engerix-B Kinder vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subject|||Number
2610701|NCT02052661|Secondary|Number of Subjects With Any Solicited General Symptoms.|Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to oe above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Day 0-3) follow-up period after the single challenge dose of Engerix-B Kinder vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subject|||Number
2610702|NCT02052661|Secondary|Number of Subjects With Any Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Day 0-3) follow-up period after the single challenge dose of Engerix-B Kinder vaccine.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Subject|||Number
2610703|NCT02052661|Secondary|Number of Subjects With an Anamnestic Response to the Single Challenge Dose of Engerix-B Kinder Vaccine.|The amnestic response to the challenge dose was defined as: for initially seronegative subjects, antibody concentration ≥ 10mIU/mL; for initially seropositive subjects, antibody concentration at least four times the pre-challenge antibody concentration.|One month after the single challenge dose of Engerix-B Kinder vaccine.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Subject|||Number
2610704|NCT02052661|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml and ≥ 10 mIU/ml.|A seropositive subject was defined as a subject with anti-HBs antibody concentrations ≥ 6.2 mIU/ml. A seroprotected subjects was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/ml.|1 month after the single challenge dose of Engerix-B Kinder vaccine.|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Subject|||Number
2611471|NCT02043379|Secondary|Immunoglobulin Concentration in Peritoneal Dialysis Drainage|Immunoglobulin concentration will be measured from chest tube and peritoneal drain every 4 hours for first 12 hours post-operative and 24 hours post-operative.|24 hours post-op||||mg/dL||Inter-Quartile Range|Median
2610705|NCT02052661|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml, ≥ 10 mIU/ml, 10 to < 100 mIU/ml and ≥ 100 mIU/ml.|A seropositive subject was defined as a subject with anti-HBs antibody concentrations ≥ 6.2 milli-international units per milliliter (mIU/ml). A seroprotected subjects was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/ml.|Before the single challenge dose of Engerix-B Kinder vaccine.|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects, aged 12-13 years at the time of enrolment, who did not received any additional dose of hepatitis B vaccine other than four doses of Infanrix hexa during first two years of life, for whom the serological results were available.|||Subject|||Number
2610706|NCT02052661|Secondary|Anti-HBs Antibody Concentrations at 12-13 Years of Age, After Previous Vaccination With Infanrix Hexa.|Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 6.2 mIU/ml.|Before (PRE) and 1 month after (POST) the single challenge dose of Engerix-B Kinder vaccine.|The analysis was performed on the According-To-Protocol cohort for persistence, which included all evaluable subjects, aged 12-13 years at the time of enrolment, who did not received any additional dose of hepatitis B vaccine other than four doses of Infanrix hexa during first two years of life, for whom the serological results were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2610707|NCT02052661|Primary|Anti-HBs Immune Response|Anti-HBs immune response was defined as the number of subjects with Anti-HBs antibody concentrations ≥ 100 mIU/ml.|One month after the single challenge dose of Engerix-B Kinder vaccine (Month 1)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.|||Subject|||Number
2610708|NCT02052635|Primary|P2Y12 Reaction Units (PRU) Using VerifyNow™ at 1 Hour After Loading Dose|PRU at 1 hour after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus|1 hour post loading dose|10 patients were included in the PD analysis: 6 patients in the ticagrelor group and 4 patients in the clopidogrel group. Out of the 10 patients in the PD analysis, 1 patient in Ticagrelor group does not have PRU value at 1 hour post loading dose.|||PRUs||Standard Deviation|Mean
2610709|NCT02052635|Primary|P2Y12 Reaction Units (PRU) Using VerifyNow™ at 0.5 Hours After Loading Dose|PRU at 0.5 hours after a single oral loading dose of either ticagrelor 180 mg or clopidogrel 600 mg given at the time of the bivalirudin bolus|0.5 hours post loading dose|10 patients were included in the pharmacodynamic (PD) analysis: 6 patients in the ticagrelor group and 4 patients in the clopidogrel group. 3 out 13 randomized pateints are excluded (1 patient without any PRU data, 2 pateints with protocol deviations)|||PRUs||Standard Deviation|Mean
2610710|NCT02052596|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination up to study end (Day 0 to Month 14)|The analisys was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2610711|NCT02052596|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2610712|NCT02052596|Secondary|Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related = pIMDs assessed by the investigator as causally related to the study vaccination.|From first vaccination up to study end (Day 0 to Month 14)|The analisys was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2610713|NCT02052596|Secondary|Number of Days With Solicited Symptoms|"The number of days with local and general symptoms have been assessed during the solicited post-vaccination period.~0 Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses"|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analisys was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented, on subjects with their symptom sheets completed.|||Days|Doses with the symptom|Inter-Quartile Range|Mean
2610714|NCT02052596|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose|"Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and fever [defined as oral, axillary, rectal or tympanic temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = temperature above (>) 39.0 °C. Related = general symptom assessed by the investigator as causally related to vaccination.~0 Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses"|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analisys was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented, on subjects with their symptom sheets completed.|||Participants|||Count of Participants
2610756|NCT02051816|Secondary|Adjusted Lowest Arterial Oxygen Saturation During Procedure|Arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death) adjusted for arterial oxygen saturation at the time of administering intubation drugs.|1 hour||||PERCENT SATURATION||Standard Deviation|Mean
2610715|NCT02052596|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine|"Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond (>) 100 millimeters (mm).~0 implies that: 1. No data were applicable for the GSK1437173A vaccine at Dose 1 for the Control Group, as it was only administered at Doses 2 and 3 in this group 2. No data were applicable for the Boostrix vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for both the groups.~3. No data were applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses."|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented, on subjects with their symptom sheets completed.|||Participants|||Count of Participants
2610716|NCT02052596|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose|"Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond (>) 100 millimeters (mm).~0 Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses"|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented, on subjects with their symptom sheets completed.|||Participants|||Count of Participants
2610717|NCT02052596|Primary|Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens|Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).|At 1 month post-Dose 1 (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included subjects meeting all eligibility criteria for whom data concerning immunogenicity endpoint measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2610718|NCT02052596|Primary|Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens|Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).|At 1 month post-Dose 1 (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included subjects meeting all eligibility criteria for whom data concerning immunogenicity endpoint measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2610719|NCT02052596|Primary|Antibody Concentrations Against Glycoprotein E (Anti-gE)|Antibody concentrations against glycoprotein E (gE) have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The reference seropositivity cut-off was an anti-gE antibody concentration greater than or equal to (≥) 97 mIU/mL.|At 1 month post-Dose 2 (Month 3 for GSK1437173A Group adn Month 5 for Control Group)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included subjects meeting all eligibility criteria for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2610720|NCT02052596|Primary|Number of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group|"This outcome was required only for the GSK1437173A Group. Vaccine response defined as:~For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration."|At 1 month post-Dose 2 (Month 3)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included subjects meeting all eligibility criteria for whom data concerning immunogenicity endpoint measures were available, only for subjects in the GSK1437173A Group.|||Participants|||Count of Participants
2610721|NCT02052544|Primary|Overall Sensitivity and Specificity of Pefakit and Hemosil.|Sensitivity is the proportion of positive cases identified as positive. Specificity is the proportion of negative cases identified as negative. The Sensitivity and Specificity of Pefakit and Hemosil were calculated for the overall study population and separately for each of the three medical centers. Sensitivity and Specificity of Pefakit and Hemosil were each assessed relative to the reference method (Biophen)|within 2 - 4 days|AVS (all valid subjects) population: All valid subjects with no major deviation affecting outcome.413 samples total analyzed|||percentage of cases||95% Confidence Interval|Number
2610722|NCT02052466|Secondary|Passive Shoulder Range of Motion - External Rotation|External rotation|At least 24 months after reverse TSA||||Degrees||Standard Deviation|Mean
2610723|NCT02052466|Secondary|Passive Shoulder Range of Motion - Abduction|Abduction|At least 24 months after reverse TSA||||Degrees||Standard Deviation|Mean
2610724|NCT02052466|Secondary|Passive Shoulder Range of Motion - Flexion|Flexion|At least 24 months after reverse TSA||||Degrees||Standard Deviation|Mean
2610725|NCT02052466|Secondary|Active Shoulder Range of Motion - External Rotation|External rotation|At least 24 months after reverse TSA||||Degrees||Standard Deviation|Mean
2610726|NCT02052466|Secondary|Active Shoulder Range of Motion - Abduction|Abduction|At least 24 months after reverse TSA||||Degrees||Standard Deviation|Mean
2610727|NCT02052466|Secondary|Active Shoulder Range of Motion - Flexion|Flexion|At least 24 months after reverse TSA||||Degrees||Standard Deviation|Mean
2610728|NCT02052466|Secondary|Shoulder Strength - External Rotation|Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.|At least 24 months after TSA||||pounds||Standard Deviation|Mean
2610729|NCT02052466|Secondary|Shoulder Strength - Internal Rotation|Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.|At least 24 months after TSA||||pounds||Standard Deviation|Mean
2610730|NCT02052466|Secondary|Shoulder Strength - Abduction|Muscle strength test will be performed three times with each motion and recorded, using the Lafayette Manual Muscle Test System (Model # 01163). Units of output are pounds.|At least 24 months after TSA||||pounds||Standard Deviation|Mean
2610732|NCT02052466|Secondary|Patient Reported Pain, Satisfaction and Function (Penn Shoulder Score)|"The Penn Shoulder Score is a shoulder-specific patient reported outcome measure. Best possible score is 100; worst possible score is 0. There are 3 sub-scores: pain (3 questions, 30 possible points), satisfaction (1 question, 10 possible points), and function (20 questions, 60 possible points). Total score is the sum of the 3 sub-scores. For all sub-scores, higher is better.~The pain questions are based on a 10-point numeric rating scale. Points are added for the pain sub-score.~The satisfaction question asks the patient to rate their satisfaction with their shoulder. It is based on a 10-point numeric rating scale, with 0 as not satisfied and 10 as very satisfied.~The function sub-score has 20 questions concerning activities of daily living. The response options are: 0 (can't do at all), 1 (can do with much difficulty), 2 (can do with some difficulty) and 3 (can do with no difficulty). If all activities can be done without difficulty, a score of 60 is achieved."|At least 24 months after reverse TSA||||Scores on the Penn Shoulder Score scale||Standard Deviation|Mean
2610733|NCT02052466|Primary|Actual Versus Predicted Scapular Notching|At minimum 2 year follow-up, compare presence of scapular notching as assessed by 2D x-ray and 3D CT imaging with predicted scapular notching as assessed by 3D computer modeling using video motion analysis of subject range of motion.|At least 24 months after reverse TSA|Patients who had video motion analysis of their range of motion at minimum 2 year follow-up|||percentage of accurate predictions|||Number
2610734|NCT02052440|Secondary|Difference in Cumulative Dose of Ethanol Withdrawal Symptom Driven Benzodiazepine Administration, as Assessed by SEWS Score, in Treatment Group Compared With Placebo Group.|The null hypotheses of no difference in the cumulative inpatient dosages of symptom-triggered benzodiazepine therapy during the 72 hours following enrollment between those who receive baclofen and those who receive placebo. Total benzodiazepine administration received from 0 to 72 hours was summed for each patient in each arm. A mean of this cumulative dose was then calculated for each arm and is reported below.|72 hours|Cumulative dose of symptom driven benzodiazepine|||Milligram of Diazepam||Standard Deviation|Mean
2610735|NCT02052440|Secondary|Difference in Maximal Dose of Ethanol Withdrawal Symptom Driven Benzodiazepine Administration, as Assessed by SEWS Score, in Treatment Group When Compared to Placebo Group|The null hypotheses of no difference in the maximum dose of inpatient symptom-triggered benzodiazepine therapy during the 72 hours following enrollment between those who receive baclofen and those who receive placebo. All maximum doses for each treatment arm given anytime between 0 and 72 hours were recorded and a mean calculated for each treatment arm.|72 hours|Maximum dose of symptom driven benzodiazepine|||Milligram of Diazepam||Standard Deviation|Mean
2610736|NCT02052440|Secondary|Reduced Severity of Alcohol Withdrawal as Measured by Severity of Ethanol Withdrawal Score. .|Severity of alcholol withdrawal will be assessed by monitoring SEWS scores in both baclofen and placebo group. This score is reported as a cumulative unit on scale ranging from 0 to 23. A value of 1-6 represents mild alcohol withdrawal, 7-12 moderate and >12 severe. Values will be measured 24 hours, 48 hours and 72 hours. A mean of these values was calculated.|Over 72 hours||||Unit on Scale||Standard Deviation|Mean
2610737|NCT02052440|Primary|Prevention of Progression to Severe Alcohol Withdrawal as Assessed by Severity of Ethanol Withdrawal Score (SEWS).|Prevention of progression to Severe Alcohol withdrawal as assessed by Severity of Ethanol Withdrawal Score (SEWS). A score of > 7 represents moderate alcohol withdrawal and a score > 12 severe alcohol withdrawal. Reported below as number of patients in each group progressing to moderate or severe alcohol withdrawal as assessed by SEWS score.|Within 72 hours||||Participants|||Count of Participants
2610738|NCT02052414|Other Pre-specified|Patient Global Impression of Change (PGIC)|Patient Global impression of Change (PGIC) is an outcome commonly used measure of the efficacy of treatments. PGIC is a 7 point scale that requires the subjects to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.|15 Weeks.||||units on a scale||Standard Deviation|Mean
2610739|NCT02052414|Secondary|Fibromyalgia Impact Questionnaire (FIQ)|The Fibromyalgia Impact Questionnaire (FIQ) is an instrument designed to quantitate the overall impact of fibromyalgia over many dimensions (e.g. function, pain level, fatigue, sleep disturbance, psychological distress etc.). It is scored from 0 to 100 with the latter number being the worst case. The average score for patients seen in tertiary care settings is about 50. The FIQ is widely used to assess change in fibromyalgia status.|15 weeks.|FM patients who took study medication.|||units on a scale||Standard Deviation|Mean
2610740|NCT02052414|Secondary|Self Reported Side Effects.|Side / adverse effects were assessed at each follow up visits and resulted are as follows.|15 Weeks|Subject who experienced pain, acute delirium, symptoms related to adhesions due to prior surgical procedures, extremity swelling, and possible drug interactions discontinued medications. Other reported side effects dissipated after subjects reached therapeutic dose of 1800mg of study medication taken at bedtime.|||participants|||Number
2610741|NCT02052414|Secondary|Medical Outcome Study (MOS) Sleep Questionnaires|"Medical Outcomes Study (MOS) sleep questionnaires to assess how Fibromyalgia impacts patients' sleep in various areas.~Specifically, Data reported below measured number of hours subjects spent per night sleeping. MOS sleep questionnaires were assessed at each follow up visits. (visits 1, 2, 3, 4, and 5)."|15 weeks||||Hours||Standard Error|Mean
2610742|NCT02052414|Primary|Numeric Pain Rating System (NPRS)|Fibromyalgia pain experienced by study subjects will be captured using NPRS at baseline visit, at each follow visits that are scheduled to occur every 4 weeks over 12 weeks of treatment period, and at the end of treatment visit that will occur 3 weeks after treatment period (12 weeks treatment period + 3 weeks = 15 weeks). Any difference in NPRS scores between baseline and any subsequent visits will indicate the magnitude of pain relief as reflected in digital scale of 0-10 (0=no pain, 10=worst pain imaginable).|15 weeks|All subjects had diagnosis of fibromyalgia and met the inclusion and exclusion criteria.|||units on a scale||Standard Deviation|Mean
2610743|NCT02052141|Secondary|Number of Participants With C1 Esterase Inhibitor (C1 INH) Antibodies in Plasma|The presence of C1 INH antibodies in plasma samples was determined using a proprietary enzyme-linked-immunosorbent-assay. Number of participants with C1 INH Antibodies was reported.|Pre-dose, 1 week post treatment (Week 13, Week 25) and 1 month post treatment follow-up (Week 28)|Safety set included all participants who received at least 1 dose of investigational product.|||Participants|||Count of Participants
2610757|NCT02051816|Secondary|ICU-mortality|Death from any cause in the ICU and at anytime after the procedure|28 days||||Participants|||Count of Participants
2610745|NCT02052141|Secondary|C1 Esterase Inhibitor (C1 INH) Functional Activity in Plasma|The functional activity of C1 INH in plasma samples was determined by a chromogenic assay.|Pre-dose and 1 h post-dose at Week 1 (Dose 1) and Week 6 (Dose 12); Pre-dose, 1, 2, 4 and 8 h post-dose at Week 12 (Dose 24) of each intervention period|PK set consisted of all pariticipants in the safety set with no major deviations related to investigational product intake and evaluable PK profiles.|||Units per milliliter (U/mL)||Standard Deviation|Mean
2610746|NCT02052141|Secondary|Plasma Concentration of C1 Esterase Inhibitor (C1 INH) Antigen|C1 INH antigen concentration in plasma was determined using an automated nephelometric assay.|Pre-dose and 1 hour (h) post-dose at Week 1 (Dose 1) and Week 6 (Dose 12); Pre-dose, 1, 2, 4 and 8 h post-dose at Week 12 (Dose 24) of each intervention period|Pharmacokinetic (PK) set consisted of all pariticipants in the safety set with no major deviations related to investigational product intake and evaluable PK profiles.|||Gram per liter (g/L)||Standard Deviation|Mean
2610747|NCT02052141|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) by Dose Group|An adverse event (AE) was any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a participant participating in a clinical study with the sponsor's product, regardless of causal relationship. TEAEs were defined as events that started or worsened on or after the date and time of the first dose of investigational product and up to 7 days after the last dose of investigational product.|From start of study treatment up to 25 weeks|Safety set included all participants who received at least 1 dose of investigational product.|||Participants|||Count of Participants
2610748|NCT02052141|Secondary|Normalized Number of Angioedema Attacks Per Month Requiring Acute Treatment in a Treatment Period|Angioedema attack was defined as the participant-reported indication of symptoms or signs such as swelling or pain at any location following a report of no swelling or pain on the previous day. Manifestations of an attack that progress from one site to another, prior to complete resolution, was considered a single attack. Attacks that began to regress and then worsened before complete resolution was also considered one attack. Attacks that began then appeared to resolve and then reappeared without a symptom-free calendar day reported after the appearance of resolution were considered 1 attack. Any events of swelling due to trauma or symmetrical nonpainful swelling of the lower extremities were not considered an angioedema attack. The number of attacks requiring acute treatment was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.|From start of treatment up to 12 weeks during each intervention period|FAS included all participants in the safety set who had at least 1 post-baseline primary efficacy assessment.|||Angioedema attacks per month||Standard Deviation|Mean
2610749|NCT02052141|Secondary|Cumulative Daily-severity Score of Angioedema Attacks Normalized Per Month in a Treatment Period|Severity of the angioedema attack sign/symptom was characterized as None: no symptom; Mild: noticeable but easily tolerated by the participant and did not interfere with routine activities; Moderate: interfered with the participant's ability to attend school or participate in family life and social/recreational activities; Severe: significantly limited the participant's ability to attend school or participate in family life and social/recreational activities. Symptom severity score was assigned as Mild = 1, Moderate = 2 and Severe = 3. Cumulative daily-severity score was the sum of the severity scores recorded for every day of reported symptoms in a treatment period. Cumulative daily-severity score normalized per month [(raw score/number of days of participation in that treatment period)*30.4] was reported here. Cumulative daily-severity score normalized per month ranged from 0 to 15.6 and higher scores represent worse symptoms.|From start of treatment up to 12 weeks during each intervention period|FAS included all participants in the safety set who had at least 1 post-baseline primary efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2610750|NCT02052141|Secondary|Cumulative Attack-severity Score of Angioedema Attacks Normalized Per Month in a Treatment Period|Severity of the angioedema attack sign/symptom was characterized as None: no symptom; Mild: noticeable symptom but easily tolerated by the participant and did not interfere with routine activities; Moderate: symptom interfered with the participant's ability to attend school or participate in family life and social/recreational activities; Severe: symptom significantly limited the participant's ability to attend school or participate in family life and social/recreational activities. Symptom severity score was assigned as Mild = 1, Moderate = 2 and Severe = 3. Cumulative attack severity score was the sum of the maximum symptom severity scores recorded for each angioedema attack in a treatment period. Cumulative attack-severity score normalized per month [(raw score/number of days of participation in that treatment period)*30.4] was reported here. Cumulative attack-severity score normalized per month ranged from 0 to 10.4 and higher scores represent worse symptoms.|From start of treatment up to 12 weeks during each treatment period|FAS included all participants in the safety set who had at least 1 post-baseline primary efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2610751|NCT02052141|Primary|Normalized Number of Angioedema Attacks Per Month in a Treatment Period|Angioedema attack was defined as the participant-reported indication of symptoms or signs such as swelling or pain at any location following a report of no swelling or pain on the previous day. Manifestations of an attack that progress from one site to another, prior to complete resolution, was considered a single attack. Attacks that began to regress and then worsened before complete resolution was also considered one attack. Attacks that began then appeared to resolve and then reappeared without a symptom-free calendar day reported after the appearance of resolution were considered 1 attack. Any events of swelling due to trauma or symmetrical nonpainful swelling of the lower extremities were not considered an angioedema attack. The number of attacks was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.|From start of treatment up to 12 weeks during each treatment period|Full Analysis Set (FAS) included all participants in the safety set who had at least 1 post-baseline primary efficacy assessment.|||Angioedema attacks per month||Standard Deviation|Mean
2610752|NCT02052011|Primary|Coronary Flow Reserve|Compare changes in coronary flow reserve as measured by cardiac PET(Positron Emission Tomography) in patients receiving Ranolazine versus control. This is the ratio between stress and rest myocardial blood flow in response to stress.|4 weeks||||ratio||Standard Deviation|Mean
2610753|NCT02051816|Secondary|Grade View of the Glottis|Best Cormack-Lehane grade view of the glottis (grade 1-4) on first laryngoscopy attempt. Higher grades on the 1-4 scale indicate worse glottic views.|1 hour||||units on a scale||Standard Deviation|Mean
2610754|NCT02051816|Secondary|Number of Esophageal Intubations Per Group|Number of esophageal intubations Per Study Group|1 hour||||number of esophageal intubations|||Number
2610759|NCT02051816|Primary|Arterial Oxygen Saturation Nadir (Defined as Lowest Noninvasive Oxygenation Saturation Value Observed Between the Administration of Sedation and/or Neuromuscular Blockade and 2 Minutes After Successfully Secured Airway or Death).|The primary outcome for the apneic oxygenation arm of the study is arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death).|1 hour||||percent arterial oxygen saturation||Inter-Quartile Range|Median
2610760|NCT02051816|Primary|Successful First Attempt at Endotracheal Intubation (Defined by Confirmed Placement of an Endotracheal Tube in the Trachea During First Laryngoscopy Attempt) After Controlling for the Operator's Past Number of Procedures With the Equipment Used.|The primary outcome for the video laryngoscopy compared with direct laryngoscopy arm of the study will be the successful first attempt at endotracheal intubation (defined by confirmed placement of an endotracheal tube in the trachea during first laryngoscopy attempt) after controlling for the operator's past number of procedures with the equipment used.|1 hour||||participants|||Number
2610761|NCT02051790|Primary|Agreement Between Expert Panel and Clinical Practice Reads|Agreement between expert panel consensus scan interpretations and clinical practice reader scan interpretations was calculated as a weighted Kappa value across all cases and all clinical practice readers.|Scan acquired 50-60 minutes post injection||||Weighted Kappa statistic||95% Confidence Interval|Number
2610762|NCT02051686|Secondary|Number of Participants That Required an Allogenic Transfusion||Perioperative (hospitalized period)||||Participants|||Count of Participants
2610763|NCT02051686|Primary|Intra-operative Blood Loss||Day of Surgery||||Milliliters||Standard Deviation|Mean
2610764|NCT02051595|Primary|Circulating Vancomycin Concentration|Blood samples to monitor the vancomycin concentration will be collected at several time points during surgery.|Time points: pre CPB (t=1), post CPB at 5 (t=2), 30 (t=3), 60 (t=4), 108 (t=5), 240 (t=6) minutes, prior to ultrafiltration (t=7), end of ultrafiltration (t=8), ultrafiltrate (t=9) ,effluent of cell saver (t=10)||||µg/mL||Standard Deviation|Mean
2610765|NCT02051452|Other Pre-specified|Post Operative Cognitive Function at ½ Hour, 1 Hour and 2 Hours After Emergence as Measured by the Mini Mental Status Exam.|Return to baseline Mini Mental Status Exam (MMSE) score after general anesthesia, measured at 30, 60, and 120 minutes following extubation. Testing is discontinued when the patient returns to their baseline pre-surgery MMSE score. A faster return to baseline represents a better outcome.|up to 4 hours||||Participants|||Count of Participants
2610766|NCT02051452|Secondary|Time to Emergence From General Anesthesia|Measured as the time from drug (MPH or saline placebo) administration to extubation|1-4 hours||||minutes||Standard Deviation|Mean
2610767|NCT02051452|Primary|Number of Participants With Adverse Events|Recorded as a measure of safety and tolerability|12 months||||Participants|||Count of Participants
2610768|NCT02051426|Primary|Change in Rey Auditory Verbal Learning Test RAVLT (Trial 7) - From Baseline to 2 Hours|RAVLT measures short term verbal memory, verbal learning, susceptibility to (proactive and retroactive) interference, retention of information after a certain period of time during which other activities are performed and recognition memory. The test consists of a list of 15 common nouns, which are read to the subject in five consecutive trials (trials 1 through 5); each reading is followed by a free-recall task. In trial 6, an interface list of 15 new common nouns is presented, followed by free recall of these new nouns. In trial 7, without additional reading, subjects are again asked to recall the first list. Twenty minutes later, without an additional reading, subjects are asked to recall once more the first list (trial 8). The RAVLT score range from 0-90 correctly recalled words. For trial 7 the score ranges from 0 to 15 correctly recalled words.|Baseline, 2 hours post intervention||||units on a scale||Standard Deviation|Mean
2610769|NCT02051426|Primary|Change in Cognitive Function- CPT-IP D-prime Score - From Baseline to 2 Hours|"The d-prime score is a score given to each participant on a scale of 0.0 - 1.0 in which discrimination sensitivity is measured. A score of 0 equates to no sensitivity whereas a score of 1.0 equates to perfect sensitivity."|Baseline, 2 hours post intervention||||units on a scale||Standard Deviation|Mean
2610770|NCT02051426|Primary|Change in Visual Analogue Scale (VAS) of Anxiety - From Baseline to 2 Hours|The subject was asked to point on the VAS scale according to his anxiety level. VAS anxiety scale 0 to 10 ( 0 [no anxiety] to 10 [maximum anxiety] ).|Baseline, 2 hours post intervention||||units on a scale||Standard Deviation|Mean
2610771|NCT02051335|Secondary|Percentage of Participants With Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post-Dose|The percentage of participants who meet markedly abnormal criteria specified by the protocol and statistical analysis plan=abnormal clinically significant.|Day 1 up to Day 95|Safety Analysis Set included all enrolled participants who received at least one dose of study drug.|||percentage of participants|||Number
2610772|NCT02051335|Secondary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements at Least Once Post-dose|The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse, and resting blood pressure and after standing.|Day 1 up to Day 95|Safety Analysis Set included all enrolled participants who received at least one dose of study drug.|||percentage of participants|||Number
2610773|NCT02051335|Secondary|Percentage of Participants With Markedly Abnormal Safety Laboratory Tests|The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis. LLN=lower limit of normal. ULN=upper limit of normal.|Day 1 up to Day 95|Safety Analysis Set included all enrolled participants who received at least one dose of study drug.|||percentage of participants|||Number
2610774|NCT02051335|Secondary|Percentage of Participants Who Experience at Least 1 Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as any adverse event, regardless of relationship to study drug that occurs or worsens after the first dose of study drug and no more than 14 days after the last dose of study drug.|Day 1 up to Day 95|Safety Analysis Set included all enrolled participants who received at least one dose of study drug.|||percentage of participants|||Number
2610775|NCT02051335|Secondary|Change From Baseline in the Spatial Working Memory (SWM) Total Number of Between Errors at the 10-Box Stage and the 12-Box Stage at All Time-points Assessed After Scopolamine Administration|SWM assesses the ability to retain spatial information and manipulate it in working memory. In this task, colored boxes are shown on the screen, and participants must search for blue tokens by touching the colored boxes to open them. When the blue token has been found the participant has to place the token in the black column ('home') on the right-hand side of the screen by touching this area. The participant must not return to a box where a token has previously been found. The task becomes more difficult as the number of boxes increases (one trial at each of 6-box and 8-box stages; three trials at each of 10-box and 12-box stages). Between Errors is the total number of times the participant revisits a box in which a token has previously been found in the same problem. The possible range of errors is 0 (best) to 1040 (worst). Lower number of errors in the test indicates a better outcome.|Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.|||errors||Standard Deviation|Mean
2610776|NCT02051335|Secondary|Change From Baseline in the Rapid Visual Information Processing (RVP) Median Latency at All Time-points Assessed After Scopolamine Administration|"RVP is a task of continuous performance and visual sustained attention. The task consists of a 2-minute practice stage and a 7-minute assessed stage. There is a white box in the centre of the screen in which single digits from 2 to 9 appear one at a time in a pseudo-random order at a rate of 100 digits per minute. Participants must detect target sequences of digits (2-4-6, 3-5-7, and 4-6-8) and touch a button when they see the last digit of a target sequence. Nine target sequences appear every 100 numbers. Assessment will be based on a median latency. The possible range for RVP median latency is 100 (worst) to 1900 (best). Higher number in the test indicates a better outcome. Median latency is a measure captured by computerized test measure and given as one time value (between 100 and 1900). The mean of these values is presented."|Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.|||msec||Standard Deviation|Mean
2610777|NCT02051335|Secondary|Change From Baseline in the Rapid Visual Information Processing (RVP) A Prime Signal Detection at All Time-points Assessed After Scopolamine Administration|RVP is a task of continuous performance and visual sustained attention. The task consists of a 2-minute practice stage and a 7-minute assessed stage. There is a white box in the centre of the screen in which single digits from 2 to 9 appear one at a time in a pseudo-random order at a rate of 100 digits per minute. Participants must detect target sequences of digits (2-4-6, 3-5-7, and 4-6-8) and touch a button when they see the last digit of a target sequence. Nine target sequences appear every 100 numbers. A prime (A') is a signal detection measure that reflects target sensitivity regardless of the participant's tendency, or bias, to respond. Detection sensitivity for RVP A' prime: 0 to 1. Lower numbers in the test indicates worsening in the performance.|Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.|||unitless||Standard Deviation|Mean
2610778|NCT02051335|Secondary|Change From Baseline in the Paired Associates Learning (PAL) Total Number of Errors Adjusted at All Time-points Assessed After Scopolamine Administration|PAL assesses visuospatial associative learning and memory. Boxes are displayed on the screen and open in a randomised order to reveal a number of patterns. The patterns are then displayed in the middle of the screen, one at a time, and the participant must touch the box where the pattern was originally located. If the participant makes an error, the patterns are re-presented to remind the participant of their locations. If the participant has not responded correctly within six attempts, ie, one presentation and five re-presentations, the task is terminated. As the task progresses the difficulty level increases with the number of patterns to be remembered. For participants who fail to complete all levels, an adjusted total is calculated that takes into account errors predicted in the stages that were not attempted. The possible range for total errors is 0 (best) to 91 (worst). Fewer number of errors in the test indicates a better outcome.|Baseline and at 1, 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.|||errors||Standard Deviation|Mean
2610779|NCT02051335|Secondary|Change From Baseline in the Verbal Recall Memory (VRM) Total Number of Correct Responses for Immediate and Delayed Recall at 2 and 4 Hours After Scopolamine Administration|VRM measures the ability to encode and subsequently retrieve verbal information. This task begins with the first presentation phase in which 18 words are shown in turn on the screen. The participant is then asked to recall as many words as possible during the first immediate recall phase. The same 18 words are then shown in a second presentation phase which is followed by a second immediate recall phase. After a delay of approximately 20-30 minutes, a delayed recall stage is completed. The possible range of correct responses is 0 (worst) to 18 (best). Higher number of correct responses in the test indicates a better outcome. A negative change from baseline indicates a worsening of the score.|Baseline and 2 and 4 hours after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.|||correct responses||Standard Deviation|Mean
2610780|NCT02051335|Primary|Change From Baseline in the Verbal Recall Memory (VRM) Total Number of Correct Responses for Immediate Recall at 1 Hour After Scopolamine Administration|VRM measures the ability to encode and subsequently retrieve verbal information. This task begins with the first presentation phase in which 18 words are shown in turn on the screen. The participant is then asked to recall as many words as possible during the first immediate recall phase. The possible range of correct responses is 0 (worst) to 18 (best). Higher number of correct responses in the test indicates a better outcome. A negative change from baseline indicates a worsening of the score.|Baseline and 1 hour after scopolamine administration on Day 1 of each treatment period.|Participants from the Full Analysis Set with data available for analysis at the given time-point.|||correct responses||Standard Deviation|Mean
2610804|NCT02050334|Secondary|Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100|16 of 18 participants had data from drug level assays.The PK parameter analysis population included participants who received single CC100 dose(s) of 2, 5, 10, and/or 20 mg. Some PK parameters had fewer participants, if there were too few data points to analyze from a participant.|||hours||Standard Error|Mean
2610781|NCT02051335|Primary|Change From Baseline in the Verbal Recall Memory (VRM) Total Number of Correct Responses for Delayed Recall at 1 Hour After Scopolamine Administration|VRM measures the ability to encode and subsequently retrieve verbal information. This task begins with the first presentation phase in which 18 words are shown in turn on the screen. The participant is then asked to recall as many words as possible during the first immediate recall phase. The same 18 words are then shown in a second presentation phase which is followed by a second immediate recall phase. After a delay of approximately 20-30 minutes, a delayed recall stage is completed. The possible range of correct responses is 0 (worst) to 18 (best). Higher number of correct responses in the test indicates a better outcome. A negative change from baseline indicates a worsening of the score.|Baseline and 1 hour after scopolamine administration on Day 1 of each treatment period. Baseline is defined as the assessment 1 hour before roflumilast/donepezil administration (3 hours before scopolamine administration).|Participants from the Full Analysis Set with data available for analysis at the given time-point.|||correct responses||Standard Deviation|Mean
2610782|NCT02051296|Primary|Time to Pain Resolution|the time until patient answers no pain at surgical site for three consecutive days|up to 365 days|94 CTR enrolled and randomized, 83 completed and reached endpoint (43 in minocycline group and 40 in placebo group) 37 TFR enrolled and randomized, 31 completed and reached endpoint (15 in minocycline group and 16 in placebo group)|||DAYS||Full Range|Median
2610783|NCT02050841|Secondary|Count of Investigator's Assessment of Overall Safety Observed for Patients by Category (Assessed to Have Overall Safety of 'Excellent', Assessed to Have Overall Safety of 'Moderate', Assessed to Have Overall Safety of 'Poor')||up to 6 days||||Participants|||Count of Participants
2610784|NCT02050841|Secondary|Medically Significant Changes in Body Temperature||up to 6 days||||units||Standard Deviation|Mean
2610785|NCT02050841|Secondary|Medically Significant Changes in Oxygen Saturation||up to 6 days||||% oxygen in blood||Standard Deviation|Mean
2610786|NCT02050841|Secondary|Medically Significant Changes in Respiratory Rate||up to 6 days||||breaths/minute||Standard Deviation|Mean
2610787|NCT02050841|Secondary|Medically Significant Changes in Heart Rate||up to 6 days||||beats per minute||Standard Deviation|Mean
2610788|NCT02050841|Secondary|Medically Significant Changes in Blood Pressure||up to 6 days||||mm of Hg||Standard Deviation|Mean
2610789|NCT02050841|Secondary|Volume (Dose in mL/kg) of Octaplas Used Per Infusion Episode for Each Patient.|Normal infusion: Replacement of multiple clotting factors Bypass priming: Limit hemodilution and reduce transfusion requirements Bypass warming up: Rewarm patients suffering from hypothermia during the surgery process|up to 6 days||||mL/kg||Standard Deviation|Mean
2610790|NCT02050841|Secondary|Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Activated Partial Thromboplastin Time (aPTT)|aPTT measures the length of time (in seconds) that it takes for clotting to occur in a test cube. The higher the number of seconds the longer it takes the blood to clot. The changes between pre - and post infusion were analyzed|up to 6 days||||participants|||Number
2610791|NCT02050841|Secondary|Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Thromboelastography (TEG) or Thromboelastometry (ROTEM).|TEG and ROTEM are methods of testing the efficiency of blood coagulation. The results were compared by looking at potential trends from TEG and ROTEM between pre-infusion vs post-infusion time points.|up to 6 days||||participants|||Number
2610792|NCT02050841|Secondary|Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: Prothrombin Time (PT)|This hemostatic parameter is figured out in the lab and measures the time it takes for your blood to clot (the higher the PT the longer it takes your blood to clot). The change of PT before and after 1st Octaplas infusion was scrutinized by analyzing the shifts between the classifications given below.|up to 6 days||||participants|||Number
2610793|NCT02050841|Secondary|Number of Participants With Clinically Significant Changes in Hemostatic Parameters as Measured by the Following: International Normalized Ratio (INR)|This hemostatic parameter is figured out in the lab and helps to diagnose a bleeding disorder or excessive clotting disorder. The change of INR before and after 1st Octaplas infusion was scrutinized by analyzing the shifts between the classifications given below.|up to 6 days||||participants|||Number
2610794|NCT02050841|Primary|Monitoring of Clinically Significant Changes in Platelets|Assesses Pre- and Post-infusion for Infusion Episode 1|up to 6 days||||10^3/µL||Full Range|Median
2610795|NCT02050841|Primary|Monitoring of Clinically Significant Changes in Red Cell Distribution Width (RDW)|Assesses Pre- and Post-infusion for Infusion Episode 1|up to 6 days||||% variation of RBC size||Full Range|Median
2610796|NCT02050841|Primary|Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin Concentration (MCHC)|Assesses Pre- and Post-infusion for Infusion Episode 1|up to 6 days||||g/dL||Full Range|Median
2610797|NCT02050841|Primary|Monitoring of Clinically Significant Changes in Mean Corpuscular Hemoglobin (MCH)|Assesses Pre- and Post-infusion for Infusion Episode 1|up to 6 days||||pg||Full Range|Median
2610798|NCT02050841|Primary|Monitoring of Clinically Significant Changes in Mean Corpuscular Volume (MCV)|Assesses Pre- and Post-infusion for Infusion Episode 1|up to 6 days||||fL||Full Range|Median
2610799|NCT02050841|Primary|Monitoring of Clinically Significant Changes in Hematocrit|Assesses Pre- and Post-infusion for Infusion Episode 1|up to 6 days||||volume percentage of RBC in blood||Full Range|Median
2610800|NCT02050841|Primary|Monitoring of Clinically Significant Changes in Hemoglobin|Assesses Pre- and Post-infusion for Infusion Episode 1|up to 6 days||||g/dL||Full Range|Median
2610801|NCT02050841|Primary|Monitoring of Clinically Significant Changes in Red Blood Cells|Assesses Pre- and Post-infusion for Infusion Episode 1|up to 6 days||||10^6/µL||Full Range|Median
2610802|NCT02050841|Primary|Monitoring of Clinically Significant Changes in White Blood Cells|Assesses Pre- and Post-infusion for Infusion Episode 1|up to 6 days||||10^3/µL||Full Range|Median
2610803|NCT02050841|Primary|Number of Participants With Adverse Drug Reactions (e.g., Allergic Reactions, TEs, TEEs (Thromboembolic Events) and Hyperfibrinolytic Events)||up to 6 days||||participants|||Number
2610858|NCT02049307|Secondary|Change in CD4+ Cell Count From Baseline to 12 Months.|Change in cluster of differentiation 4 (CD4+) cell count from baseline to 12 months|Baseline and 12 months||||Cells/mm^3||Standard Error|Mean
2610805|NCT02050334|Secondary|Pharmacokinetics (PK)|Time to Reach Maximum Observed Plasma Concentration (Tmax)|0.5, 1, 2, 3, 4, 5, 8, 12, 24 hrs post CC100|16 of 18 participants had data from drug level assays.The PK parameter analysis population included participants who received single CC100 dose(s) of 2, 5, 10, and/or 20 mg. Some PK parameters had fewer participants, if there were too few data points to analyze from a participant.|||hours||Standard Error|Mean
2610806|NCT02050334|Primary|Unsolicited Adverse Event Reports|Safety and Tolerability assessed by arm/group and dose received measured by number of unsolicited AEs within a minimum of 24 hours after each dose.|Minimum of 24 hours after each dose.|All 18 subjects analyzed, per protocol.|||Unsolicited Adverse Event Reports|||Number
2610807|NCT02050321|Secondary|Number of Participants With Adverse Events|The study period during which all AEs must be reported begins after informed consent is obtained and initiation of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier. All adverse events will be classified using either the MedDRA term or NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|Baseline through 30 Days post Treatment|Per the PI: Although there is no measurable or interpretable data for this study. One patient had higher than normal liver lab results and was removed from study treatment due to grade and severity. Patient safety was evaluated.|||Participants|||Count of Participants
2610808|NCT02050321|Primary|Rate of Development of cSCC at 6 Months (Biopsy Confirmed).||6 months post treatment|Per the PI: There is no measurable or interpretable data for this study. Only two patients were enrolled before the study closed to accrual due to recent FDA approvals of drugs for melanoma.Patients were removed from protocol prior to reaching data points or the completing the study.||||||
2610809|NCT02050308|Secondary|Adherence to Program Participation|adherence rates to study protocol procedures over the course of 6 months|6 months|||||||
2610810|NCT02050308|Secondary|Number of Quit Attempts|comparison of the number of serious quit attempts between the two groups using Poisson regression|6 months|||||||
2610811|NCT02050308|Secondary|Cigarettes Smoked|effect of intervention on the number of cigarettes smoked daily among those who continue to smoke at Month 6|Change from Baseline to 6 Months|||||||
2610812|NCT02050308|Primary|Number of Participants With 7-day Point Prevalence Abstinence|self-reported and biochemically (salivary cotinine) verified point prevalence abstinence, defined as no smoking for the previous 7 days, at the 6-month follow-up.|6 months||||Participants|||Count of Participants
2610813|NCT02050048|Secondary|Number of Participants With Adverse Events Related to Fluid Overload|A portion of the study will assess whether there is a significant risk of adverse events related to fluid overload states in the high volume (HV) intervention arm. We anticipate the rate of adverse events in patients randomized to the HV arm to be small. By using more modest, weight based regimens, we aim to optimize benefit while eliminating overly aggressive fluid administration and causing undue harm.|Phase II portion (~1 year)|||||||
2610814|NCT02050048|Primary|Development of Post-ERCP Pancreatitis|Patients will be monitored after procedure to see if they develop abdominal pain. If so, serum amylase and lipase blood draws will be completed at least once every 24 hours following procedure to monitor the development of post-ERCP pancreatitis. If patients do not develop abdominal pain following the procedure, research staff will follow up with the patients 5 days and 29 days after the procedure to evaluate for the development of post-ERCP pancreatitis and other related or unrelated complications.|Assessed 90 minutes after procedure, 5 days after procedure, and 29 days after procedure||||participants|||Number
2610815|NCT02049957|Secondary|Phase 1: Terminal Elimination Half-life (T1/2) for Sapanisertib||Cycle 1 Day 15 pre-dose and multiple timepoints (Up to 8 hours) post-dose|Participants from PK Population, participants with sufficient dosing and PK data to reliably estimate PK parameters. PK data was not available for Phase 1 (Part 1): Sapanisertib 5 mg + Fulvestrant arm group at Cycle 1 Day 15.|||hour||Standard Deviation|Mean
2610816|NCT02049957|Secondary|Phase 1: AUC(0-last): Area Under the Plasma Concentration-time Curve From Time 0 to Last Extrapolated Concentration Over the Dosing Interval for Sapanisertib|AUC(0-last) is the area under the plasma concentration-time curve of the samples collected up to 8 hours and extrapolated up to last time point.|Cycle 1 Day 15 pre-dose and multiple timepoints (Up to 8 hours) post-dose, extrapolated to last timepoint|PK Population included participants with sufficient dosing and PK data to reliably estimate PK parameters. PK data was not available for Phase 1 (Part 1): Sapanisertib 5 mg + Fulvestrant arm group at Cycle 1 Day 15. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||h*ng/mL||Standard Deviation|Mean
2610817|NCT02049957|Secondary|Phase 1: AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to Time 24 Hours for Sapanisertib|AUC(0-24) is the area under the plasma concentration-time curve of the samples collected up to 8 hours and extrapolated up to 24 hours.|Cycle 1 Day 15 pre-dose and multiple timepoints (Up to 8 hours) post-dose, extrapolated to 24 hours post-dose|Participants from PK Population included participants with sufficient dosing and PK data to reliably estimate PK parameters. PK data was not available for Phase 1 (Part 1): Sapanisertib 5 mg + Fulvestrant arm group at Cycle 1 Day 15. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||h*ng/mL||Standard Deviation|Mean
2610818|NCT02049957|Secondary|Phase 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Sapanisertib||Cycle 1 Day 15 and Cycle 2 Day 1 pre-dose and multiple timepoints (Up to 8 hours) post-dose|PK Population included participants with sufficient dosing and PK data to reliably estimate PK parameters. PK data was not available for Phase 1 (Part 1): Sapanisertib 5 mg + Fulvestrant arm group at Cycle 1 Day 15. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||hour||Full Range|Median
2610819|NCT02049957|Secondary|Phase1: Cmax: Maximum Observed Plasma Concentration for Sapanisertib||Cycle 1 Day 15 and Cycle 2 Day 1 pre-dose and multiple timepoints (Up to 8 hours) post-dose|Pharmacokinetic (PK) Population included participants with sufficient dosing and PK data to reliably estimate PK parameters. PK data was not available for Phase 1 (Part 1): Sapanisertib 5 mg + Fulvestrant arm group at Cycle 1 Day 15. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||ng/mL||Standard Deviation|Mean
2610820|NCT02049957|Secondary|Phase 2: Best Percent Change From Baseline in Tumor Size||Baseline to Month 24|Participants from Safety Population included participants who received at least 1 dose of study drug and provided both baseline and at least one post-baseline disease response.|||percentage change in tumor size||Standard Deviation|Mean
2610821|NCT02049957|Secondary|Phase 2: Overall Survival (OS)|OS is the time in months from start of study treatment to date of death due to any cause. Data for the analysis of OS included the censored data at the timepoint that the participant was last known to be alive.|Up to 24 months|Safety Population included participants who received at least 1 dose of study drug. Participants without documentation of death at the time of analysis were censored at the date last known to be alive.|||months||95% Confidence Interval|Median
2610822|NCT02049957|Secondary|Phase 2: Progression-Free Survival (PFS)|PFS is defined as the time in months from the date of first dose of study treatment to the date of the first documented disease progression or death. Disease progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; or the appearance of one or more new lesions.|Baseline then every 2 cycles from Cycles 2 through 6, and every 3 cycles thereafter in a 28-day cycle, then every 3 months after EOT until disease progression or death (Up to 24 months)|Safety Population included participants who received at least 1 dose of study drug. For a participant whose disease had not progressed and was last known to be alive, PFS was censored at the last response assessment that was stable disease or better.|||months||95% Confidence Interval|Median
2610823|NCT02049957|Secondary|Phase 2: Overall Response Rate (ORR)|ORR is defined as the percentage of participants with confirmed CR or PR as per RECIST version1.1 guidelines. CR is disappearance of all target lesions. PR is >=30% decrease in the sum of the longest diameter of target lesions.|Baseline then every 2 cycles from Cycles 2 through 6, and every 3 cycles thereafter in a 28-day cycle up to End of Treatment (EOT) (Up to 24 months)|Response-Evaluable Population included participants who received at least 1 dose of study drug and had measurable disease at baseline.|||percentage of participants||95% Confidence Interval|Number
2610824|NCT02049957|Secondary|Phase 2: Clinical Benefit Rate at 24 Weeks (CBR-24)|CBR-24 was defined as the percentage of participants who achieved confirmed CR or PR at any time or had confirmed SD as best response and the first 2 or more post baseline scans had PR/SD and the duration of stable disease was >168 days. Disease response was assessed for target lesions by CT or MRI according to RECIST version 1.1 guidelines. CR is disappearance of all target lesions. PR is >=30% decrease in the sum of the longest diameter of target lesions. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Week 24|Response-Evaluable Population included participants who received at least 1 dose of study drug and had measurable disease at baseline.|||percentage of participants||95% Confidence Interval|Number
2610825|NCT02049957|Primary|Phase 2: Clinical Benefit Rate at 16 Weeks (CBR-16)|CBR-16 was defined as the percentage of participants who achieved confirmed complete response (CR) or partial response (PR) of any duration or had confirmed stable disease (SD) as best response and the first 2 or more post baseline scans had PR/SD and the duration of SD was >112 days. Disease response was assessed for target lesions by computed tomography (CT) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. CR is disappearance of all target lesions. PR is >=30% decrease in the sum of the longest diameter of target lesions. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression (PD).|Week 16|Response-Evaluable Population included participants who received at least 1 dose of study drug and had measurable disease at baseline.|||percentage of participants||95% Confidence Interval|Number
2610826|NCT02049957|Primary|Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug.~A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug will be determined by the Investigator."|First dose of study drug through 30 days after the last dose (Up to 52 months)|Safety Population included participants who received at least 1 dose of any study drug.|||Participants|||Count of Participants
2610827|NCT02049931|Secondary|the Progression of Body Compression Ratio Over All Follow-up Assessments|The anterior body compression ratio was assessed by calculating the ratio between the vertical height of the most compressed anterior section of the injured vertebral body and the posterior vertebral body height at that level|2 weeks, 6 weeks, and 12 weeks after compression fracture||||ratio||Standard Deviation|Mean
2610828|NCT02049931|Secondary|General Health Status|The general health status was assessed with use of the Short Form-36 Health Survey (SF-36) at the initial enrollment and 12 weeks after compression fracture.The raw scores for the eight subscales and the two summaries of the SF-36 (Physical Function,Role Physical, Bodily Pain, General Health, Vitality, Social Function, Role Emotion, and Mental Health, as well as the Physical Component Summary [PCS] and the Mental Component Summary [MCS]) were transformed into norm-based 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability, and the higher the score the less disability. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|at the initial enrollment and 12 weeks after compression fracture||||units on a scale||Standard Deviation|Mean
2610829|NCT02049931|Secondary|Oswestry Disability Index (ODI)|The ODI is a self-reported questionnaire measuring back-specific function including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. The questionnaire consists of 10 items each with 6 response levels. Each item is scored from 0 to 5, and the total score is converted to a 0 to 100 scale (zero is equated with no disability and 100 is the maximum disability possible).|at 2 weeks, 6 weeks, and 12 weeks after compression fracture.||||units on a scale||Standard Deviation|Mean
2610830|NCT02049931|Secondary|Visual Analog Pain Scale (VAS) for Back Pain|"The VAS for back pain comprised a 10-cm line with none (0) on one end and disabled pain (10) on the other. Participants were asked to place a mark on the 10-cm line, which represented his or her perceived level of back pain, and the measured distance (cm) from the mark to the zero point was considered the score."|2 weeks, 6 weeks, 12 weeks after injury||||units on a scale||Standard Deviation|Mean
2610831|NCT02049931|Primary|Oswestry Disability Index (ODI) at 12 Weeks|The primary outcome was the score for Oswestry Disability Index (ODI) at 12 weeks after compression fracture. The ODI is a self-reported questionnaire measuring back-specific function including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. The questionnaire consists of 10 items each with 6 response levels. Each item is scored from 0 to 5, and the total score is converted to a 0 to 100 scale (zero is equated with no disability and 100 is the maximum disability possible).|12 weeks after injury||||units on a scale||95% Confidence Interval|Mean
2610832|NCT02049814|Secondary|Change From Baseline in Body Weight Over Time|The change between body weight at weeks 2, 6 and 12 or relative to baseline.|Baseline, Weeks 2, 6 and 12|PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.|||kg||Standard Error|Least Squares Mean
2610833|NCT02049814|Secondary|Change From Baseline in Insulin Homeostatic Model Assessment Beta Cell Function (HOMA β) at Week 12|The change between the value of HOMA-beta cell function collected at Week 12 and HOMA-beta cell function collected at Baseline. The homeostatic model assessment estimates steady state beta cell function as a percentage of a normal reference population (%B). HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5.|Baseline, Week 12|PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.|||Percentage beta cell function||Standard Error|Least Squares Mean
2610834|NCT02049814|Secondary|Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance (HOMA IR) at Week 12|The change between the value of HOMA-IR collected at Week 12 and HOMA-IR collected at Baseline. HOMA IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5. A higher number indicates a greater insulin resistance.|Baseline, Week 12|PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.|||Insulin resistance||Standard Error|Least Squares Mean
2610835|NCT02049814|Secondary|Change From Baseline in Postprandial Serum Glucagon at Week 12|The change from Baseline in postprandial serum glucagon, after 1 and 2 hours of meal collected at Week 12 relative to baseline.|1 and 2 hours after meal at Baseline and Week 12|PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.|||pg/mL||Standard Error|Least Squares Mean
2610836|NCT02049814|Secondary|Change From Baseline in Fasting Glucagon at Week 12|The change between the fasting glucagon value collected at week 12 or final visit relative to baseline.|Baseline, Week 12|PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.|||pg/mL||Standard Error|Least Squares Mean
2610837|NCT02049814|Secondary|Change From Baseline in Postprandial Serum Insulin at Week 12|The change from Baseline in postprandial serum insulin, after 1 and 2 hours of meal collected at Week 12 relative to baseline.|1 and 2 hours after meal at Baseline and Week 12|PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.|||μU/dL||Standard Error|Least Squares Mean
2610838|NCT02049814|Secondary|Change From Baseline in Fasting Insulin at Week 12|The change between the fasting insulin value collected at week 12 or final visit relative to baseline.|Baseline, Week 12|PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.|||μU/dL||Standard Error|Least Squares Mean
2610839|NCT02049814|Secondary|Change From Baseline in Postprandial Plasma Glucose (PPG) Over Time|The change between the value of glucose after 1 and 2 hours of meal, measured by the meal tolerance test collected at Weeks 6 and 12 or relative to baseline.|1 and 2 hours after meal at Baseline, Weeks 6 and 12|PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.|||mmol/L||Standard Error|Least Squares Mean
2610840|NCT02049814|Secondary|Change From Baseline in Fasting Blood Glucose Over Time|The change between the fasting blood glucose value collected at weeks 6 and 12 or final visit relative to baseline.|Baseline, Weeks 6 and 12|PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.|||mmol/L||Standard Error|Least Squares Mean
2610841|NCT02049814|Secondary|Change From Baseline in HbA1c at Week 6|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 6 relative to baseline.|Baseline and Week 6|PPS is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.|||percentage of glycated hemoglobin||Standard Error|Least Squares Mean
2610842|NCT02049814|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit relative to baseline.|Baseline, Week 12|Per Protocol Set (PPS) is a subset of FAS, including participants who completed treatment as was prescribed in protocol and had no important protocol deviation.|||percentage of glycated hemoglobin||Standard Error|Least Squares Mean
2610843|NCT02049749|Secondary|Changes From Baseline in Parental Disciplinary Practices Assessed at Different Time Points (Baseline up to 18 Weeks)|"Investigators want to determine the effect of the CARE intervention on diminishing harsh parenting as measured by the Adult Adolescent Parenting Inventory-2.~The Adult Adolescent Parenting Inventory-2 (AAPI-2) is a 40 item parent-report measure that assesses parenting attitudes along 5 dimensions: inappropriate expectations of children, parental lack of empathy towards children's needs, strong belief in the use of corporal punishment as a means of discipline, reversing parent-child role responsibilities, and oppressing children's power and independence.~Parents respond to each item on a five point Likert Scale of Strongly Agree, Agree, Disagree, Strongly Disagree and Uncertain. This measure yields a score of 1-10 for each construct. Higher scores indicate lower risk parenting."|Mean change in scores from baseline to 14-18 weeks. Increases in scores indicate decreased risk for abuse and better outcomes.|Adult Adolescent Parenting Inventory (AAPI-2): assesses 5 parenting constructs:1) inappropriate expectations of child,2) lack of empathy towards child’s needs,3)belief in corporal punishment, 4) reverses parent-child roles, 5) restricts child’s power and independence.Range for each scale is 1-10. Lower numbers indicate higher abuse risk.|||units on a scale||Standard Deviation|Mean
2610844|NCT02049749|Primary|Change From Baseline in the Eyberg Child Behavior Inventory (ECBI) Score at Different Time Points (Baseline up to 18 Weeks)|Behavior will be measured by the Eyberg Child Behavior Inventory (ECBI). The primary outcome is the ECBI change score (time 3-time1). The ECBI is a parent rating scale designed to measure conduct problem behaviors in children ages 2-16 years. The instrument contains 36 items that assess behavior on two scales. The problem scale provides a yes/no problem identification rating for each item, and the sum of yes responses yields a problem score with a potential range from 0 to 36 with a clinical cutoff of 15. The intensity scale provides a frequency-of-occurrence rating for each item, ranging from never (1) to always (7) and the ratings are summed to yield an intensity score with a potential range from 36 to 252 with a clinical cutoff of 131. Higher scores indicate worse outcomes. The ECBI has demonstrated strong internal consistency, test-retest reliability, and discriminant validity and has been shown to be a sensitive indicator of intervention efficacy for child behavior problems.|Mean Change in ECBI Scores from Baseline to 14-18 weeks. Decreases in ECBI scores reflect improvements in behavior.|Eyberg Child Behavior Inventory (ECBI) is a 36 item parent rating scale that measures problem behaviors in children 2-16 on the problem scale and intensity scale.The intensity score (range 36-252) is the total frequency of occurrence for the behaviors. The problem score (range 0-36) is the total number of behaviors for which the response is “yes”.|||units on a scale||95% Confidence Interval|Mean
2610845|NCT02049502|Secondary|Number of Patients With Favorable Microbiota Profile|16s ribosomal gene sequencing and metabolomic profile of the gut microbiota|3 months||||Participants|||Count of Participants
2610846|NCT02049502|Primary|Number of Patients Who Experienced Improvement of Pouchitis Symptoms|Improvement of clinical pouchitis symptoms based on the clinical component of the modified pouchitis disease activity index (mPDAI) without relapse. These components include: stool frequency (number of stools), rectal bleeding, fecal urgency or abdominal cramps, or fever (temperature >37.8C).|3 months||||Participants|||Count of Participants
2610847|NCT02049476|Other Pre-specified|Number of Eyes With a Need for Cataract Surgery|Number of eyes that had progression of cataract defined as any interval increase in nuclear, cortical or posterior sub capsular cataract from a previous visit that resulted in cataract surgery.|Baseline, 1 month, 3 months, 6 months, and 12 months visit||||eyes|eyes||Count of Units
2610848|NCT02049476|Other Pre-specified|Mean Intraocular Pressure (IOP)|Mean IOP (mmHg) was calculated at each visit|Baseline, 1 month, 3 months, 6 months, and 12 months visit||||millimeters of Mercury (mm Hg)|eyes|Standard Deviation|Mean
2610849|NCT02049476|Secondary|Number of Participants With Absence of Intraocular Inflammation at 12 Months|Absence of intraocular inflammation (e.g. less than trace anterior chamber (AC) cells; no vitreous haze; inactive chorioretinal lesions) is used to assess control of intraocular inflammation following treatment.|12-month clinical visit||||Participants|||Count of Participants
2610850|NCT02049476|Primary|Number of Participants With Absence of Intraocular Inflammation at 6 Months|Absence of intraocular inflammation (e.g. less than trace anterior chamber (AC) cells; no vitreous haze; inactive chorioretinal lesions) is used to assess control of intraocular inflammation following treatment.|at 6-month visit||||Participants|||Count of Participants
2610851|NCT02049450|Secondary|Pharmacokinetics (PK) Parameter of Cmax|"Cmax (1h) of INC424 by actual dose administered from 10mg bid to 20mg bid. Plasma PK samples were collected at Day 1, Week 2, and Week 12. Cmax was collected within a +/- 1 hour post dose.~n= number of patients with valid PK samples as per definition of the PK analysis set."|Day 1, Week 2 (Day 15), Week 12 (Day 85)|The PK analysis set includes all patients with at least one evaluable PK sample at any visit.|||ng/mL||Standard Deviation|Mean
2610852|NCT02049450|Secondary|Pharmacokinetics (PK) Parameter of Cmin|C min of INC424 by actual dose administered from 10mg bid to 20mg bid. Plasma PK samples were collected at Day 15 (Week 2), and Day 85 (Week 12). Cmin was collected immediately prior to dosing. n= number of patients with valid PK samples as per definition of the PK analysis set.|week 2, week 12|The PK analysis set includes all patients with at least one evaluable PK sample at any visit.|||ng/mL||Standard Deviation|Mean
2610853|NCT02049450|Secondary|Percentage Change in Spleen Length (cm) Below the Left Coastal Margin|Change of spleen length from baseline over time measured by palpitation by time|baseline, weeks 1,2,3,4,6,12,18,24,30|The Safety Set consists of all patients who received at least one dose of ruxolitinib. All safety data was analyzed using the Safety set. The FAS and Safety set are identical in this study.|||percentage change in spleen length||Standard Deviation|Mean
2610854|NCT02049450|Secondary|Percentage Change in Mean Pre-transfusion Hemoglobin by 6 Week Time Intervals|Change from baseline in pre-transfusion hemoglobin levels|baseline, weeks 0 - 30|The Safety Set consists of all patients who received at least one dose of ruxolitinib. All safety data was analyzed using the Safety set. The FAS and Safety set are identical in this study.|||percentage change of hemoglobin levels||Standard Deviation|Mean
2610855|NCT02049450|Secondary|Percentage Change in Spleen Volume (cm3)|Change of spleen volume from baseline at week 12 and week 30 as measured by magnetic imaging resonance (MRI) or computed tomography (CT).|baseline, week 12, week 30|The Safety Set consisted of all patients who received at least one dose of ruxolitinib. All safety data was analyzed using the Safety set. The FAS and Safety set are identical in this study.|||percentage change||Standard Deviation|Mean
2610856|NCT02049450|Primary|Change of Hematocrit Adjusted Volume of Red Blood Cells (RBC)|Change of RBC transfusion requirement measured as percent change of the hematocrit-adjusted volume of transfused RBC and observed during within on-treatment interval (any time-points of RBC transfusion between week 6 and week 30 driven by the individual patient's need) compared to baseline (defined by pre-treatment interval between Week - 24 to start of treatment).|week 6 to week 30 interval|Per-Protocol Set (PPS) consisted of a subset of patients in the Safety Set who were compliant with requirements of the Study Protocol. Patients were excluded from the PPS if: they had no or incomplete history of RBC transfusions within 24 weeks prior to the first dose of ruxolitinib or discontinued treatment with ruxolitinib prior to Week 18.|||% change of hematocrit-adjusted volume||Standard Deviation|Mean
2610857|NCT02049385|Primary|MADRS Change at Day 7|Change in Montgomery Asberg Depression Rating Scale (MADRS) from baseline to 7 days post-treatment. The range of values is from 0 - 60, with a higher score indicating increased depressive symptoms. A score of 7-19 indicates mild depression; 20-34 indicates moderate depression; >34 indicates severe depression.|7 days|The analysis included those subjects who started treatment and completed treatment with Diazoxide or Placebo through at least 7 days.|||percentage of change in units of scale||Full Range|Median
2610860|NCT02049151|Secondary|Number Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, National Cancer Institute-Common Toxicity Criteria (NCI−CTC)Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, Injection Site Reactions (ISRs)|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs occurred between the first dose of study drug and up to 42 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of Subjects With TEAEs, Serious TEAEs, NCI−CTC Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, and ISRs were reported.|Time from first dose up to 42 days after the last dose of the trial treatment: assessed maximum up to 16 months|Safety Analysis Set included all subjects who had taken at least one dose of trial treatment (tecemotide [L-BLP25] or placebo), including cyclophosphamide or saline.|||subjects|||Number
2610861|NCT02049151|Secondary|Time to Progression (TTP)|TTP was measured from the date of randomization to the date of tumor progression. Date of tumor progression was date of radiological diagnosis of PD, performed as per RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression. For participants alive without tumor progression at time of analysis, the time between date of randomization and date of last trial treatment was calculated and used as a censored observation in the analysis. Subjects dying from causes other than PD was censored at time of death.|Time from date of randomization until PD, assessed up to 16 months|Analysis was not performed due to the premature termination of this study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115).||||||
2610862|NCT02049151|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from date of randomization until date of the first documentation of PD or death due to any cause in the absence of documented PD, whichever occurred first. PFS was assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). PD was defined as at least a 20% increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Subjects without event were censored on the date of last tumor assessment.|Time from date of randomization until PD or death, assessed up to 16 months|Analysis was not performed due to the premature termination of this study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115).||||||
2610863|NCT02049151|Secondary|Time to Symptom Progression (TTSP)|TTSP was measured from date of randomization to date of disease progression (defined based on RECIST v1.1), using the lung cancer symptom scale (LCSS), a validated questionnaire consisting of an observer scale and a subject scale used to specifically measure symptom changes relevant to quality of life (QoL) for individuals undergoing treatment for lung cancer. Subject scale was used as a tool to determine TTSP. It was a 9-item questionnaire used to document subject-reported outcomes for a variety of lung cancer associated symptoms. The average symptomatic burden index (ASBI) was used to determine differences in the treatment groups. ASBI was the mean of the 6 symptom scores derived from the LCSS questionnaire. Symptom progression was defined as an increase (worsening) of the ASBI score of 10% of the scale breadth (10 mm on a scale of 0-100 mm) from the baseline score on at least 2 consecutive assessments during the period when assessments are performed every 3 weeks and every 6 weeks.|Time from date of randomization until progressive disease (PD), assessed up to 16 months|Analysis was not performed due to the premature termination of this study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115).||||||
2610864|NCT02049151|Primary|Overall Survival|Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number subjects who died and number of censored subjects.|Time from date of randomization until death, assessed maximum up to 16 months|Safety Analysis Set included all subjects who had taken at least one dose of trial treatment (tecemotide [L-BLP25] or placebo), including cyclophosphamide or saline. Analysis was not performed due to the premature termination of this study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115).|||subjects|||Number
2610865|NCT02048904|Primary|Change in Microalbuminuria Level|Decrease in microalbuminuria level|Six months|Zero participants were analyzed due to early termination of study related to technical/operational difficulties at the study site.||||||
2610866|NCT02048891|Secondary|Patients Comfort During the Luteal Phase||During 2 weeks from day of oocyte retrieval|||||||
2610867|NCT02048891|Primary|Fetal Heart Activity 1 Month After Oocyte Retrieval|Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval|1 month after oocyte retrieval||||participants with fetal heart activity|||Number
2610868|NCT02048878|Secondary|Noninvasive Beat-to-beat Blood Pressure Monitoring||2 months after enrollment|Two insomnia subjects and 3 control subjects dropped out of the study after completing their first inpatient visit due to scheduling conflicts related to their professional occupation.|||mm Hg||Standard Deviation|Mean
2610869|NCT02048878|Secondary|Electroencephalography (EEG) During Wake and Sleep|The EEG will be measured continuously during sleep and at frequent intervals during wake. The signal will be submitted to power spectral analysis to examine spectral power in frequency bands that are typical of arousal and in frequency bands that are typical of deep sleep.|2 months of enrollment|The biological signals were recorded but not submitted to the labor-intensive spectral analysis due to end of funding. Summary data were not generated. Therefore, no results on this outcome can be reported.||||||
2610870|NCT02048878|Secondary|Heart Rate Variability During Wake and During Sleep|The balance between sympathetic and parasympathetic nervous control of the heart will be determined by spectral analysis of heart rate variability using continuous electrocardiogram (ECG) recording for 24 hours, including the normal sleep period.|2 months after enrollment|The biological signals were recorded but not submitted to the labor-intensive spectral analysis due to end of funding. Summary data were not generated. Therefore, no results on this outcome can be reported.||||||
2610871|NCT02048878|Secondary|Multiple Sleep Latency Test (MSLT)|MSLT will be used to objectively quantify tendency to fall asleep (sleep latency).|2 months of enrollment|One insomnia subject and one good sleeper control could not remain in the laboratory for the entire duration of the test due to personal scheduling issues.|||minutes||Standard Deviation|Mean
2610874|NCT02048670|Secondary|Visual Analog Scales Score|For the therapy portion of the study aim #2 Visual Analog Scales (VAS) related to the intensity of symptoms provoked by visual motion, head movements and walking in visually complex environments. The average Visual Analog Scale scores for the patient group pre and post therapy will be compared for any significant difference in the score (p<0.05). The VAS ranges from 0-10, where 0 is no symptoms and 10 is the most intense symptoms experienced.|baseline|This outcome measure was not evaluated in this study. No data have been collected for this outcome measure.||||||
2610875|NCT02048670|Primary|Degrees of Sway|The Sensory Organization Test is a six condition standard evaluation of balance control performed on a dynamic platform that can record sway movement in the A/P dimension while the sensory inputs from proprioception and vision are varied though the platform and visual surround movements. Condition 1 - eyes open, visual locked, platform locked. Condition 2 - eyes closed, visual locked, platform locked. Condition 3 - eyes open, visual unlocked, platform locked. Condition 4 - eyes open, visual locked, platform unlocked. Condition 5 - eyes closed, visual locked, platform unlocked. Condition 6 - eyes open, visual unlocked, platform unlocked. All participants progress though the exam, starting with condition 1 and ending with condition 6. All conditions were completed two to three times depending on performance with the average of each condition reported.|baseline||||degrees of sway||Standard Error|Mean
2610876|NCT02048241|Primary|Number of Participants That Were Responders|Overall response to treatment is defined as at least a 70% decline in both the Modified Overt Aggression Scale (MOAS) score and the Symptom Checklist-6 (SCL-6) from randomization to end of study. The MOAS measures the severity of explosive overt aggression. The score can range from 0 (no overt aggressive) and it has no theoretical upper limit (incidents could be too many to count). The higher the score, the more serious the aggression; the lower the score, the less serious the aggression. Response to treatment is defined as a 70% or more reduction in the MOAS at the end of the study. The SCL-6 uses 6 subscale items from the larger SCL that measure hostility or irritability on a scale of 1 (not at all) - 5 (definitely). The raw score ranges from 6 (no irritability) to 30 (severe irritability). The lower the score is, the better the outcome. The % decline vary from 0%-100%. A 70% or more decline in the SCL-6 score at the end of study is a response.|up to 8 weeks||||Participants|||Count of Participants
2610877|NCT02048072|Primary|RMSSD Normal Breathing|"Root Mean Square of the Successive Differences (RMSSD) is one of a few time-domain tools used to assess heart rate variability, the successive differences being neighboring RR or pulse intervals.~It is calculated as the square root of the mean of the squares of the successive differences between adjacent RR intervals or pulse intervals.~In this study pulse intervals were measured non-invasively during five minutes, while subjects were supine, breathing regularly.~Measurements were done at two timepoints t=0 and t=4,5hours. RMSSD was compared between these two timepoints."|t-4,5 hours||||milliseconds||95% Confidence Interval|Mean
2610878|NCT02047981|Secondary|Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Malawi Only)|Cause-specific mortality by intention-to-treat for the four main inferred causes of death in the study area.|24 Months||||deaths per 1000 person-years||95% Confidence Interval|Number
2610879|NCT02047981|Secondary|Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Tanzania Only)|At 6-monthly intervals a census of the communities was conducted, and for child deaths a verbal autopsy was performed to ascertain the cause using a standardized diagnostic classification. Mortality due to pneumonia or diarrhea by age group and arm are shown in the outcome measure data table below.|24 Months||||deaths per 100 person-years|||Number
2610880|NCT02047981|Secondary|All-cause and Cause-specific Health Clinic Visits in 1-60 Month-old Children||24 months|||||||
2610881|NCT02047981|Secondary|Cost-effectiveness of Mass Azithromycin Administration, Per Averted Childhood Death||24 months|||||||
2610882|NCT02047981|Secondary|Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)|Deaths were assessed via biannual population census. A pre-specified outcome was cause of death, assessed by verbal autopsy.|24 Months||||Deaths per 1000 person years||95% Confidence Interval|Number
2610883|NCT02047981|Primary|All-cause Mortality Rate in Children Aged 1-60 Months|This was a pre-specified contingency study in Niger only in which all communities were treated with mass azithromycin during the third year of the study following the primary 24-month endpoint.|36 months||||deaths per 1000 person-years||95% Confidence Interval|Number
2610884|NCT02047981|Primary|All-cause Mortality Rate in Children Aged 1-60 Months|This is a single multi-site trial, with each country as a secondary analysis. Also, an interim analysis of efficacy and futility will be conducted according to a pre-specified plan in the Statistical Analysis Plan.|24 Months||||deaths per 1000 person-years|||Number
2610885|NCT02047929|Secondary|Medication Adherence|Additional measures that will be evaluated to determine the success of dissemination will be based on indicators of poor asthma control including: medication adherence (controller medication refills). Data was not collected.|18 months|Data was not collected||||||
2610886|NCT02047929|Secondary|Health Outcomes|Health outcomes data collected from Continuing Care of North Carolina that indicate poor asthma control and/or marker for exacerbations. These include patients with: Emergency Department Visits, Hospitalizations, Oral Steroid prescriptions, or patients with one or more of the markers for exacerbation: Emergency Department Visits, Hospitalizations, Oral Steroid prescriptions.|18 months|Medicaid Patients diagnosed with Asthma|||Participants|||Count of Participants
2610887|NCT02047929|Primary|Patient Perception of Shared Decision Making|Success of the dissemination process will be determined by looking at process and outcome measures collected at the patient and clinic level. The primary outcome will be the patient's perceptions of shared decision making using a patient survey.|18 months|Number of surveys collected. Per the protocol, surveys were not collected for the Usual Care cohort.|||Participants|||Count of Participants
2610888|NCT02047903|Secondary|Percentage of Participants With Treatment Modification|Percentage of participants with treatment modification was calculated as percentage of participants with any dose reduction, dose escalation or any modification.|From the initial dose of study drug until end of the treatment period, up to 48 months.|TS|||Percentage of participants|||Number
2610909|NCT02047344|Other Pre-specified|Objective Response Rate (ORR)|Defined as the proportion of patients whose best overall response is either CR or PR according to RECIST version 1.1. The best overall response is the best response recorded during the first 12 week treatment cycle.|12 weeks|full sey analysis group|||patients|||Number
2610889|NCT02047903|Secondary|Symptom Control - Time to Worsening (Cough, Dyspnea and Pain)|Symptom control was evaluated for cough, dyspnea and pain. Time to deterioration was calculated from date of baseline European Organisation for Research and Treatment of Cancer (EORTC) questionnaire until date of the EORTC questionnaire, where the first deterioration was measured. Patients without deterioration were censored at their date of last answered EORTC questionnaire, where the corresponding scale is evaluable. Participants had to select one answer on a scale ranging from 1=Not at All to 4=Very Much for questions 1 to 28 and 31 to 43 and on scale ranging from 1=Very Bad to 7=Excellent for questions 29 and 30. Afterwards, these scale scores were linearly transformed such that all scales ranged from 0 to 100, where higher scores represented higher level of symptoms.|Up to 48 months|TS|||Months||95% Confidence Interval|Median
2610890|NCT02047903|Secondary|Treatment Duration|Duration of treatment with afatinib is calculated as Date of last administration + 1 day − Date of first administration.|From the initial dose of study drug until end of the treatment period, up to 48 months.|TS|||Days||Full Range|Median
2610891|NCT02047903|Secondary|Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia|Toxicity and side-effect profile: incidence of diarrhea, skin reactions, stomatitis and paronychia. Skin reactions: acne, dermatitis acneiform, dry skin, pruritus, rash, rash maculo-papular, rash pustular.|From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.|TS|||Percentage of participants|||Number
2610892|NCT02047903|Secondary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs).|From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.|Treated set (TS): This patient set included all patients who received at least one dose of afatinib.|||Percentage of participants|||Number
2610893|NCT02047903|Secondary|Progression Free Survival (PFS)|PFS was measured from start of therapy until progression or death, whichever came first. Progression was defined as the minimum of the first examination with progression and the date of progression documented by the treating physician. One day was added to the corresponding date. Patients without documented progression and not known to have died were censored at their date of last examination and one day was added. Median was derived by Kaplan Meier methods.|From first administration of the trial drug until objective tumour progression or death, up to 48 months.|PPS|||Months||95% Confidence Interval|Median
2610894|NCT02047903|Secondary|Disease Control Rate (DCR)|Percentage of participants with controlled disease (CR + PR + stable disease (SD)) as best unconfirmed response. CR, PR and SD were determined by investigators by using RECIST/WHO/clinical evidence as investigators deemed appropriate|From the initial dose of study drug until end of the treatment period, up to 48 months.|PPS|||Percentage of participants||95% Confidence Interval|Number
2610895|NCT02047903|Secondary|Objective Response Rate (ORR)|Objective response rate is calculated as a percentage of participants with complete response (CR) or partial response (PR) (i.e CR+PR) as best unconfirmed response. Here CR and PR were determined by investigators by using RECIST/WHO/clinical evidence as investigators deemed appropriate.|From the initial dose of study drug until end of the treatment period, up to 48 months.|PPS|||Percentage of participants||95% Confidence Interval|Number
2610896|NCT02047903|Primary|Progression Free Survival (PFS) Rate After 12 Months|The rate (probability) of being progression free after 12 months. PFS is defined as the time from first administration of the trial drug until objective tumor progression or death. The rate is the Kaplan-Meier estimated percent probability.|After 12 months|Per protocol set (PPS): This set included all patients who gave their informed consent, did not violate any inclusion or exclusion criterion and have at least one documented administration of afatinib.|||Percent probability of PFS||95% Confidence Interval|Number
2610897|NCT02047747|Secondary|Treatment-emergent Adverse Events||End of Treatment (4-6 weeks after permanent discontinuation of study treatment for any reason)|The study was terminated due to slow enrollment. Please see adverse event section for additional information.||||||
2610898|NCT02047747|Primary|Intra-cranial Objective Response Rate|Intra-cranial objective response rate at 2 months as assessed by the Response Assessment in Neuro-oncology (RANO) criteria|2 months|Subjects did not complete the study as planned. Zero participants analyzed due to termination of study. Data not available.||||||
2610899|NCT02047643|Secondary|Count of Participants With Hypoglycemia in the Post Exercise Period|A hypoglycemic event was defined as (1) any meter blood glucose (BG) reading of ≤60 mg/dl, (2) two consecutive meter BG readings ≤70 mg/dl done within one hour, or (3) any instance in which carbohydrates were given at a subject's request for symptoms of hypoglycemia|In the time following exercise until the following morning (up to 24 hours)||||Participants|||Count of Participants
2610900|NCT02047643|Primary|Count of Participants Experiencing a Hypoglycemic Event During Scheduled Exercise|The primary outcome will be a hypoglycemic event defined as (1) any meter blood glucose (BG) reading of ≤60 mg/dl, (2) two consecutive meter BG readings ≤70 mg/dl done within one hour, or (3) any instance in which carbohydrates were given at a subject's request for symptoms of hypoglycemia|Measurements occurring during exercise (up to 8 hours)||||Participants|||Count of Participants
2610901|NCT02047500|Secondary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs)||Baseline up to Day 30 after the last dose of study treatment|||||||
2610902|NCT02047500|Secondary|Tumor Metabolic Response Assessed by Positron Emission Tomography (PET) Scans According to European Organization for Research and Treatment of Cancer (EORTC) Criteria||Baseline and 8 weeks after Day 1 of Cycle 1|||||||
2610903|NCT02047500|Secondary|Percentage of Subjects With Disease Control According to RECIST Version 1.1 Criteria||Every 8 weeks from Day 1 of Cycle 1 until disease progression or within 1 week after discontinuation of study treatment|||||||
2610904|NCT02047500|Secondary|Duration of Overall Response According to RECIST Version 1.1 Criteria||Every 8 weeks from Day 1 of Cycle 1 until disease progression or within 1 week after discontinuation of study treatment|||||||
2610905|NCT02047500|Secondary|Percentage of Subjects With Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1) Criteria||Every 8 weeks from Day 1 of Cycle 1 until disease progression or within 1 week after discontinuation of study treatment|||||||
2610910|NCT02047344|Secondary|T½: the Time Required for a Quantity to Reduce to Half Its Initial Value|PK sampling will be performed on Days 0 and 28 in all patients enrolled in Stage 1.PK endpoints will be derived for intensively sampled PK profiles by T½: terminal half life|8 hours||||hours||Inter-Quartile Range|Mean
2610911|NCT02047344|Secondary|Disease Control Rate (DCR)|the proportion of patients with a documented CR, PR and SD during the first 12 week treatment cycle according to RECIST version 1.1.|12 weeks|26 patients can be run the full analysis|||percentage of participants||95% Confidence Interval|Number
2610912|NCT02047344|Secondary|Cmax|PK sampling will be performed on Days 0 and 28 in all patients enrolled in Stage 1.PK endpoints will be derived for intensively sampled PK profiles by non compartmental methods and include: Cmax: peak concentration;Ctrough: trough plasma concentration.|8 hours|There were 22 patients with reported concentration data who were eligible for the PK population.|||ng/mL||Standard Deviation|Mean
2610913|NCT02047344|Primary|Progression Free Survival Rate|Tumor response will be assessed at 6 week intervals during the first treatment cycle using the RECIST criteria, version 1.1. Each patient will be assigned one of the following categories: 1) complete response (CR), 2) partial response (PR), 3) stable disease (SD), or 4) progressive disease (PD). Patients who died from any cause or discontinued the study for any reason without a post screening or Week 12 tumor assessment will be considered as failing to respond to treatment.|12 weeks|Defined as the proportion of patients alive and progression free at Week 12.|||Participants|||Count of Participants
2610914|NCT02047253|Secondary|Assessment of Toxicities|"Hematologic and non-hematologic toxicities will be graded. The new international criteria proposed by the Response Evaluation Criteria In Solid Tumors (RECIST) will serve as the guideline.~On Day 1 of each cycle (4 weeks) for the duration of treatment and then 30 days following the last treatment"|Baseline through 36 months|All serious adverse events and > grade 3 toxicities were reported for patients who received treatment with Carfilzomib|||Participants|||Count of Participants
2610915|NCT02047253|Secondary|Number of Participants With Circulating Tumor Cell (CTC) Decline Over Three Time Points (Before Study Initiation, Day 1 of Cycles 2 and 4|"The CTC marker will be used to evaluate efficacy of response to treatment. CTC changes will include changes from unfavorable (less than or equal to 5/7.5 ml) to favorable and declines by >30%.~Three collections: before study initiation, Day 1 of Cycles 2 and 4"|Baseline through 36 months|1 patient did not have blood draw. 27 patients had blood draws for CTC enumeration across baseline, Cycle 2 day 1 and cycle 4 day 1.|||Participants|||Count of Participants
2610916|NCT02047253|Secondary|Number of Participants With Prostate-Specific Antigen (PSA) Changes|PSA levels were collected at each visit on the day of treatment. Linear regression with PSA as the dependent variable and time as the dependent variable was performed.|Baseline through 36 months|We were unable to collect blood specimen for PSA analysis for 1 patient.|||Participants|||Count of Participants
2610917|NCT02047253|Primary|Overall Survival|Outcome measure was completed by using a count of participants.|From baseline through 36 months.|8 patients did not complete treatment and were lost to follow up|||Participants|||Count of Participants
2610918|NCT02047253|Primary|Progression-free Survival (PFS)|The study will measure patient survival at 6 months but will continue to monitor overall survival as a secondary objective. The Kaplan-Meier method will be used.|Baseline through 6 months for evaluating all patients|8 patients did not complete treatment and were not included in the analysis.|||Participants|||Count of Participants
2610919|NCT02047227|Secondary|Biochemical Pregnancy Rate|Biochemical pregnancy rate was defined as the percentage of subjects with a positive beta-hCG result from the serum pregnancy test.|15 to 20 days post r-hCG administration (Day 132)|MITT Analysis Set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.|||percentage of subjects|||Number
2610920|NCT02047227|Secondary|Clinical Pregnancy Rate|Clinical pregnancy rate defined as the percentage of subjects with a ultrasound confirmation of a gestational sac, with or without fetal heart activity.|35-42 days post r-hCG administration (Day 154)|MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.|||percentage of subjects|||Number
2610921|NCT02047227|Secondary|Embryo Implantation Rate|Embryo implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred multiplied by 100.|35-42 days post r-hCG administration (Day 154)|"MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration. Here Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."|||percent sacs per embryo|||Number
2610922|NCT02047227|Secondary|Live Birth Rate|Live birth rate was defined as the percentage of subjects with at least one live-born neonate.|Approximately 180 days following ongoing pregnancy determination (Day 365)|MITT analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.|||percentage of subjects|||Number
2610923|NCT02047227|Secondary|Ongoing Pregnancy Rate|Ongoing pregnancy rate was defined as the percentage of subjects with a ultrasound confirmation of at least one viable fetus (positive fetal heart beat).|70 days after embryo transfer (Day 185)|Modified intent-to-treat (MITT) analysis set included all randomized subjects who received at least 1 dose of GONAL-f or Pergoveris and did not have spontaneous pregnancy or death at approximately 34-38 hours after rhCG administration.|||percentage of subjects|||Number
2610924|NCT02047227|Primary|Number of Oocytes Retrieved|Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.|At approximately 34 to 38 hours after r-hCG administration (Day 113)|Intent-to-treat (ITT) analysis set included all subjects randomized who received at least 1 dose of GONAL-f or Pergoveris.|||oocytes||Standard Deviation|Mean
2610925|NCT02047110|Secondary|Percentage of Patients Who Achieved ASAS 40 Improvement Criteria at Week 24|Percentage of patients who achieved ASAS 40 improvement criteria at Week 24 is presented|Week 24|Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication|||Percentage of participants|||Number
2610926|NCT02047110|Secondary|Change From Baseline to Week 12 in Disease Activity Assessed by BASDAI|"BASDAI assesses the AS disease activity of a patient within the last week based on 6 questions on a NRS (1 to 10) How would you describe the overall level of~fatigue/tiredness you have experienced?~AS neck, back or hip pain you have had?~pain/swelling in joints other than neck, back or hips you have had?~discomfort you have had from any areas tender to touch or pressure?~morning stiffness you have had from the time you wake up? How long does your~morning stiffness last from the time you wake up?~A score of 10 means very severe disease activity for each of the BASDAI questions 1, 2, 3, 4 and 5. BASDAI question 6 addresses the stiffness duration. A NRS of 0 means 0 h; a NRS of 10 mean ≥2 h.~The BASDAI was computed in the following way: the sum of the values of question 1 to 4 was calculated and the mean of questions 5 and 6 was added. This value was divided by 5."|Baseline and Week 12|FAS|||Unit on scale||Inter-Quartile Range|Median
2610927|NCT02047110|Secondary|Percentage of Patients Who Achieved ASAS 20 Improvement Criteria at Week 12|"ASAS 20 evaluations are based on the following 4 components (also called domains) that include patient' self-assessments on a numerical rating scale (NRS) from 0 to 10 with higher numbers representing a worse disease status:~Global AS disease activity~Inflammation based on the mean of Bath AS Disease Activity Index (BASDAI) questions addressing the level of morning stiffness and duration~Spinal pain based on the mean of 2 questions~Physical function based on the Bath AS Functional Index (BASFI) The ASAS 20 response is defined as an improvement in 3 of 4 components and no worsening in the remaining component; an improvement is defined as a reduction from baseline of ≥20% and an absolute reduction of ≥1 units in each of the 3 components."|Week 12|Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication|||Percentage of participants|||Number
2610928|NCT02047110|Secondary|Percentage of Patients Who Achieved Partial Remission According to the ASAS Criteria at Week 12|Percentage of patients who achieved partial remission according to the ASAS criteria at Week 12 is presented|Week 12|Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication|||Percentage of participants|||Number
2610929|NCT02047110|Secondary|Percentage of Patients Who Achieved ASAS 5/6 Improvement Criteria at Week 12|"The ASAS 5/6 evaluation is based on 6 components:~Global AS disease activity~Inflammation based on the mean of BASDAI questions addressing the level-of morning stiffness and duration~Spinal pain~Physical function based on the Bath AS Functional Index (BASFI)~Spinal mobility assessment (lateral lumbar flexion), corresponding to one out of 5 measurements of Bath Ankylosing Spondylitis Metrology Index (BASMI)~Serum CRP levels The ASAS 5/6 response is defined as an improvement in any 5 of the 6 components and no worsening in the remaining component. A reduction from baseline of ≥20% is defined as an improvement according to the ASAS criteria."|Week 12|Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication|||Percentage of participants|||Number
2610930|NCT02047110|Secondary|Change From Baseline to Week 12 in Disease Activity Assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS).|This is the key secondary endpoint. ASDAS is a linear function of Back Pain (Question 2 from Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI): range 0-10), Duration of Morning Stiffness (Question 6 from BASDAI: range 0-10), Patient's global assessment of the disease on Numerical rating Scale (NRS) (range 0-10), peripheral joint pain/swelling (Question 3 from BASDAI: range 0-10) and the C-reactive protein (CRP) lab value at the visit. ASDAS-CRP: 0.121*Back pain +0.058*Duration of Morning Stiffness +0.11*Patient Global + 0.073*Peripheral pain/ Swelling + 0.579*Ln (CRP +1). For all of the scales that make up the ASDAS, higher indicates worse disease.|Baseline and Week 12|FAS|||Unit on scale||Inter-Quartile Range|Median
2610931|NCT02047110|Primary|Percentage of Patients Who Achieved Assessment of Spondyloarthritis International Society (ASAS) 40 Improvement Criteria at Week 12.|"ASAS 40 evaluations are based on the following 4 components (also called domains) that include patient' self-assessments on a numerical rating scale (NRS) from 0 to 10 with higher numbers representing a worse disease status:~Global AS disease activity~Inflammation based on the mean of Bath AS Disease Activity Index (BASDAI) questions addressing the level of morning stiffness and duration~Spinal pain based on the mean of 2 questions~Physical function based on the Bath AS Functional Index (BASFI) The ASAS 40 response is defined as an improvement in 3 of 4 components and no worsening in the remaining component; an improvement is defined as a reduction from baseline of ≥40% and an absolute reduction of ≥2 units in each of the 3 components."|Week 12|Full Analysis set (FAS): FAS comprised of all randomised patients who received at least 1 dose of trial medication|||Percentage of participants|||Number
2610932|NCT02047045|Post-Hoc|the Proportion of Sustained CSBM Responder Over Weeks 1-8||over weeks 1-8||||percentage of participants|||Number
2610933|NCT02047045|Post-Hoc|the Proportion of Overall CSBM Responders Over Weeks 1-8|A weekly CSBM responder was defined as a patient who had ≥3 CSBMs for a given week and an increase from baseline of ≥1 CSBM for that same week. An overall CSBM responder was a patient who was a weekly CSBM responder for at least 6 of the 8 treatment weeks (75%).|over weeks 1-8||||percentage of participants|||Number
2610934|NCT02047045|Other Pre-specified|Average Dosage of Glycerine Enema Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.||over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.||||ml||Inter-Quartile Range|Median
2610935|NCT02047045|Other Pre-specified|Average Dosage of Bisacodyl Used Weekly Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.||over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.||||mg||Inter-Quartile Range|Median
2610936|NCT02047045|Other Pre-specified|Proportion of Patients Using Rescue Medicine Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.||over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.||||percentage of participants|||Number
2610937|NCT02047045|Secondary|Change From Baseline in Mean Score of Patient Assessment of Constipation Quality of Life|The change from baseline of the score of Patient Assessment of Constipation Quality of Life (PAC-QOL) at week 4 and week 8. PAC-QOL is a self-report questionnaire to evaluate the quality of life in patients with constipation, which was distributed by Mapi Research Trust in France. This questionnaire contains 28 items including 4 basic parts of physical discomfort, worries and concerns, psychosocial discomfort, and satisfaction. We use the Chinese version in our trial. Assessing point: baseline, week 4 and week 8. The score of PAC-QOL ranged from 1 to 5 (1 indicates no discomfort or feeling very satisfied, 5 indicates extreme severity and always appears or feeling very dissatisfied).|week 4 and week 8|The number of participants providing data of PAC-QOL was 261 in EA group and 260 in prucalopride group at week 4; The number of participants providing data of PAC-QOL was 261 in EA group and 257 in prucalopride group at week 8.|||score||Standard Deviation|Mean
2610938|NCT02047045|Secondary|Time to the First CSBMs|Abbreviation: CSBMs, complete spontaneous bowel movements. Time to the first CSBMs was counted by days. Rescue medicine or other measurements for constipation is not allowed to be used 48 hours before and after the first treatment for evaluating the time to the first complete spontaneous bowel movement. Participants were assessed after the first treatment until they having their first CSBMs.|from the time of their first treatment to the time they having their first CSBMs|The number of participants providing data of time to the first CSBMs was 272 in EA group and 266 in prucalopride group.|||days||Inter-Quartile Range|Median
2610939|NCT02047045|Secondary|the Change From Baseline in Mean Score of Straining for Each SBM Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.|The change from baseline in the mean score of straining of each SBM over weeks 1-2, 3-8, 9-12, 9-16, 9-20, 9-32. Assessing time: baseline, weeks 1-2, 3-8, 9-12, 9-16, 9-20, 9-32. Patients will self-report their straining degree of each SBM in the defecation diaries according to the following scale. 0 = not difficult; 1 = a little difficult, need some straining to defecate; 2 = difficult, need straining to defecate; 3 = very difficult, need hard straining to defecate. Higher scores mean a worse outcome.|over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.|The number of participants providing data of straining was 271 in EA group and 266 in prucalopride group over weeks 1-2/3-8; The number of participants providing data of straining was 264 in EA group and 261 in prucalopride group over weeks 11-12/15-16/19-20/31-32.|||score||Inter-Quartile Range|Median
2610940|NCT02047045|Secondary|the Change From Baseline in Mean Score of Stool Consistency for Each SBM Over Weeks 1-2 and 3-8.|"The change from baseline in the mean score of stool consistency of each SBM over weeks 1-2 and weeks 3-8. Assessing time: baseline, weeks 1-2 and weeks 3-8. Patients will self-report their stool consistency of each SBM according to the 7-type Bristol Stool Form Scale (scored by 1 to 7 respectively). Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (passed easily); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces. Entirely liquid.~Type 3 and 4 were deemed as a normal stool."|over weeks 1-2, 3-8.|The number of participants providing data of stool consistency was 270 in EA group and 266 in prucalopride group.|||score||Inter-Quartile Range|Median
2610941|NCT02047045|Secondary|Mean Weekly SBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.||over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.|We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.|||bowel movements||95% Confidence Interval|Mean
2610942|NCT02047045|Secondary|Mean Weekly CSBMs and Its Change From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.||over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.|We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.|||bowel movements||95% Confidence Interval|Mean
2610943|NCT02047045|Secondary|the Proportion of Participants With ≥1 Increase in Mean Weekly CSBMs From Baseline Over Weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.|"Abbreviation: CSBMs, complete spontaneous bowel movements. Calculation method: First, the increase in mean weekly CSBMs of each patient from baseline were calculated over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32. Second, we got the number of patients with ≥1 increase in the mean weekly CSMBs from baseline. Third, we got the proportion of participants through dividing that number by the total cases at baseline, and multiplying by 100%.~Assessing time frame: weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32."|over weeks 1-2, 3-8, 11-12, 15-16, 19-20, 31-32.|We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.|||percentage of participants|||Number
2610944|NCT02047045|Secondary|the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 1-2, 11-12, 15-16, 19-20, 31-32.|"Abbreviation: CSBMs, complete spontaneous bowel movements. Calculation method: First, the mean weekly CSBMs of each patient were calculated over weeks 1-2, 11-12, 15-16, 19-20, 31-32. Second, we got the number of patients with 3 or more mean weekly CSMBs. Third, we got the proportion of participants through dividing that number by the total cases at baseline, and multiplying by 100%.~Assessing time frame: weeks 1-2, 11-12, 15-16, 19-20, 31-32."|over weeks 1-2, 11-12, 15-16, 19-20, 31-32.|We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the analysis.|||percentage of participants|||Number
2610945|NCT02047045|Primary|the Proportion of Participants With ≥3 Mean Weekly CSBMs Over Weeks 3-8|"Abbreviation: CSBMs, complete spontaneous bowel movements. Calculation method: First, the mean weekly CSBMs of each patient were calculated over weeks 3-8. Second, we got the number of patients with 3 or more mean weekly CSMBs. Third, we got the proportion of participants through dividing that number by the total cases at baseline, and multiplying by 100%.~Assessing time frame: the latter 6 weeks of treatment (weeks 3-8)."|over weeks 3-8 (the latter 6-week treatment)|We recruited 560 participants (280 for each group) in total; however, 3 participants from EA group and 2 from prucalopride group withdrew their informed consents. Therefore, they were not included in the baseline analysis.|||percentage of participants|||Number
2610946|NCT02047032|Secondary|Change of Episodes From Baseline in Mean 72-h Incontinence Episodes||Weeks 1-12, 13-24, 25-36|1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.|||episodes||95% Confidence Interval|Least Squares Mean
2610947|NCT02047032|Secondary|The Number of Participants Using Urine Pads||Weeks 1-12, 13-24, 25-36|For various reasons, the participants discontinued study.|||Participants|||Count of Participants
2610948|NCT02047032|Secondary|Electroacupuncture Acceptance Assessment|The acceptance of electroacupuncture will be tested within 5 minute with a 5-point scale ('0' means very difficult to accept and '4' means accept easily). Median of scores of the three times will be calculated.|Weeks 2, 6 and 12|1 patient withdrew consent and did not receive electroacupuncture treatment.|||units on a scale||Inter-Quartile Range|Median
2610949|NCT02047032|Secondary|Patient Global Impression Improvement|Participants will be asked to finish one item evaluating their present condition.|Weeks 12, 36|1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.|||Participants|||Count of Participants
2610950|NCT02047032|Secondary|Patient's Treatment Satisfaction Degree|The self-assessing satisfaction degree on a 5-point Likert scale (range, 1 [unsatisfied strongly] to 5 [satisfied strongly]) will be finished by participants to evaluate their satisfaction for the treatment.|Weeks 12, 36|1 patient withdrew consent and did not receive electroacupuncture treatment. 2 refused to participate and did not receive PFMT-solifenacin treatment.|||Participants|||Count of Participants
2610951|NCT02047032|Secondary|the Amount of Urine Leakage (Grams) Measured by the 1-hour Pad Test at Weeks 4 and 12|"The performance of 1-hour pad test according to the International Incontinence Society:~Participants were instructed to void 2 hours before the pad test. On arrival, they received a pre-weighed pad and were asked to sit and drink 500 ml sodium-free water in 15 minutes. Next, they were instructed to walk for 30 minutes, including going up and down 24 stairs. On returning to the clinic, the participants were instructed to perform several activities, including standing and sitting 10 times, coughing vigorously 10 times, running for 1 minute, picking up a coin from the floor 5 times, and putting their hands under water for 1 minute. After the activities were completed, the pad was reweighed to measure the amount of urinary leakage using a gram sensitive weight scale (Xiangshan, EK3820)."|Weeks 4 and 12|1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.|||amount of leakage (grams)||95% Confidence Interval|Least Squares Mean
2610952|NCT02047032|Secondary|Weekly Median Number of Urine Pads Used During Weeks 1-12, 13-24, and 25-36||Baseline, weeks 1-12, 13-24, 25-36|1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.|||urine pads||Inter-Quartile Range|Median
2610953|NCT02047032|Secondary|Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score|The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF (range, 0 [best]-21 [worst] outcomes, and 2.52 as minimal clinically important differences (MCID)) scores.|baseline, weeks 12, 24 and 36||||units on a scale||95% Confidence Interval|Least Squares Mean
2610954|NCT02047032|Secondary|Change of Episodes From Baseline in Average 72-hour Urgencies/Urination/Nocturia Episodes|The average 72-h IEF (urinary incontinence, stress urinary incontinence and urgency urinary incontinence respectively) is calculated based on a 72-h bladder diary. For example, the average 72-h incontinence episodes from the 13th to 36th week equal to the sum of 72-h incontinence episodes of the 16th, 20th, 24th, 28th, 32nd, 36th weeks divided by 6.|Baseline, weeks 1-12, 13-24, 25-36|1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.|||percent change||95% Confidence Interval|Least Squares Mean
2610955|NCT02047032|Secondary|Percentage of Participants With ≥50% Decrease in Average 72-h Incontinence Episode Frequency|Count the number of cases with the reduction of average 72-h incontinence episode frequency ≥50% and divide it by the number of participants at baseline.|Weeks 1-12, 13-24, 25-36|For various reasons, participants discontinued study.|||Participants|||Count of Participants
2610956|NCT02047032|Secondary|Percentage of Change From Baseline in Mean 72-hour IEF During Weeks 13-24 and Weeks 25-36|Calculated as the same way as the primary outcome. But this outcome will be assessed at different time point.|baseline, weeks 13-24, week 25-36|1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.|||percent change||95% Confidence Interval|Least Squares Mean
2610957|NCT02047032|Primary|Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12|The average 72-h IEF is calculated based on a 72-h bladder diary. All relevant time points used in the calculation in the Time Frame (baseline, weeks 1-12)|baseline, weeks 1-12|1 patient withdrew consent and did not receive electroacupuncture treatment, 2 refused to participate and did not receive PFMT-solifenacin treatment.|||percent change||95% Confidence Interval|Least Squares Mean
2610958|NCT02046993|Primary|Comparison Between Mean Home Systolic and Diastolic Blood Pressure HSBP and HDBP Readings at 6 Months Between the Smartphone Based Telemonitoring Group and Control Group on Enhanced Usual Care|At baseline and follow-up visits, research assistants will collect the HSBP and HSBP readings of both groups at baseline, 3rd and 6th month FU. Regular home BP measurement is taken as the average of at least 3 or more BP measurement readings per week. The research assistant are not blinded and will collect the average of paper SBP and DBP measurement recordings ( if done) of the control group at baseline,at 3rd month and 6th month. The research assistant are not blinded and will collect the average of smartphone based SBP and DBP measurement recordings ( if done) and sent to the data center of the intervention group at baseline,at 3rd month and 6th month.|6 months|The mean average of the HSBP and HDBP of both groups who have taken and recorded their blood pressure readings at least 3x or more per week are collected|||mmHg||Standard Deviation|Mean
2610959|NCT02046993|Primary|Comparison of Mean Home Systolic and Diastolic Blood Pressure mHSBP and mHDBP Readings at 3 Months Between Smart Phone Based Telemonitoring Group and Control Group on Enhanced Usual Care|At baseline and follow-up visits, research assistants will collect the HSBP and HSBP readings of both groups at baseline, 3rd and 6th month FU. Regular home BP measurement is taken as the average of at least 3 or more BP measurement readings per week. The research assistant are not blinded and will collect the average of paper SBP and DBP measurement recordings ( if done) of the control group at baseline,at 3rd month and 6th month. The research assistant are not blinded and will collect the average of smartphone based SBP and DBP measurement recordings ( if done) and sent to the data center of the intervention group at baseline,at 3rd month and 6th month.|3 months|The mean average of the HSBP and HDBP of both groups who have taken and recorded their blood pressure readings at least 3x or more per week are collected|||mmHg||Standard Deviation|Mean
2610960|NCT02046993|Primary|Comparison of Mean Home Systolic and Diastolic Blood Pressure mHSBP and mHDBP Readings Between Intervention and Control Grp at Baseline|At baseline and follow-up visits, research assistants will collect the HSBP and HSBP readings of both groups at baseline, 3rd and 6th month FU. Regular home BP measurement is taken as the average of at least 3 or more BP measurement readings per week. The research assistant are not blinded and will collect the average of paper SBP and DBP measurement recordings ( if done) of the control group at baseline,at 3rd month and 6th month. The research assistant are not blinded and will collect the average of smartphone based SBP and DBP measurement recordings ( if done) and sent to the data center of the intervention group at baseline,at 3rd month and 6th month.|baseline|The mean average of the HSBP and HDBP of both groups who have taken and recorded their blood pressure readings at least 3x or more per week are collected|||mmHg||Standard Deviation|Mean
2610961|NCT02046993|Secondary|Self-efficacy for Managing Chronic Disease: 6 Items Scale (SEMCD-6 Items) Comparing Both Groups at 3 and 6 Months Post-intervention|This is a 6-items scale for measuring confidence of patients in self management of their chronic disease. Each item has a likert scale from 1 to 10 with 10 as most confident. Higher score indicating higher self-efficacy|6 months||||units on a scale||Standard Deviation|Mean
2610962|NCT02046993|Primary|Change in Mean Clinic Systolic and Diastolic Blood Pressure CSBP and CDBP Readings at 3 and 6 Months From Baseline|At baseline and follow-up visits, research assistants who are blinded to allocation outcomes will meaure blood pressure after 15 minutes rest with validated electronic automated sphygmanometer ( ) . Four blood pressure readings taken at 1 minute interval will done for each subject and the mean of the second and third reading would be used for the primary outcome ,|baseline, 3rd month and 6 month|Intention to treat analysis was used and the last known data were carried forward to replace missing values for drop-outs.|||mmHg||Standard Deviation|Mean
2610963|NCT02046993|Primary|Percentage of Subjects Doing Home BP Monitoring|Percentage of subjects doing home BP monitoring with at least BP recordings of three or more times/week|Baseline, 3rd month, 6th month||||percentage of subjects doing HBPM|||Number
2610964|NCT02046980|Primary|Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus||2 days|217 patients enrolled in the study but 8 retracted their agreements.|||participants|||Number
2610965|NCT02046941|Secondary|Percentage Change in Fractional Anisotropy (FA)|To measure neuroplasticity associated with the speech treatment protocol, the investigators calculated the percent change in fractional anisotropy (FA) from pre- to post-treatment for each of the eight fiber tracts in the left hemisphere. The average percentage change in FA across all eight fiber tracts was calculated, which could thus range from 0-100%. A positive change indicates an increase in white matter integrity, and a negative change indicates a decrease in white matter integrity. A number close to 0 indicates minimal/no significant change.|8 weeks||||average percent change in FA||Standard Deviation|Mean
2610966|NCT02046941|Primary|Change From Baseline in Percent of Untrained Items Correctly Repeated|To test generalization, we assessed the change in performance (percent correct repetition) on lists of 10 Untrained Items that had the same speech production targets as each patient's lists of 10 Trained Items, balanced for syllabic structure, word frequency, grammatical form class, and stress pattern. Just as for Trained Items, participants were tested on the lists of Untrained Items (probe trials) during repeated sessions in the pre-intervention stage to establish baseline performance and during every other treatment session (percent of each word list repeated correctly). The change in percent correct list repetition from pre-intervention (5 probe trials) to end of intervention (final 3 probe trials) was calculated as individual treatment effect sizes using the d2 statistic: the difference between mean performance at end of the intervention minus pre-intervention, divided by the pooled standard deviation. The larger the d2 effect size, the larger the effect of the treatment.|8 weeks||||d2 treatment effect size||Standard Deviation|Mean
2610967|NCT02046941|Primary|Change From Baseline in Percent of Trained Items Correctly Repeated|For each participant, three target sounds were chosen: single consonants, vowels, or clusters at the word level. Based on these target sounds, 10 word items were generated for each target sound that served as Trained Items. Participants were tested on lists of Trained Items (probe trials) during repeated sessions in pre-intervention stage to establish baseline performance (percent of each word list repeated correctly) and during every other treatment session (again, percent of each word list repeated correctly). The change in percent correct list repetition from pre-intervention (5 probe trials) to the end of intervention (final 3 probe trials) was calculated as individual treatment effect sizes using the Busk & Serlin (1992) d2 statistic, which involves subtracting the difference between mean performance at end of the intervention minus pre-intervention, divided by the pooled standard deviation of the two phases. The larger the d2 effect size, the larger the effect of the treatment.|8 weeks||||d2 treatment effect size||Standard Deviation|Mean
2610968|NCT02046902|Secondary|Concordance Between Stent Preference and Stent Received Was a Secondary Outcome.|"Secondary outcomes included patients' recall of individual aspects of the stent discussion, stent knowledge score, patient preference for stent type, perceived autonomy support from their providers ,and concordance of patient stent preference and type of stent received. Patients were categorized as having voiced a stent preference if they answered anything other than I don't care or I don't know in response to the question After reviewing the risks and benefits of both types of stents, which type of stent did you want?"|30 months||||Participants|||Count of Participants
2610969|NCT02046902|Primary|Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching|"The primary outcome was whether or not patients participated in SDM regarding stent choice. Patients were categorized as having participated in SDM if they answered anything other than doctor alone in response to the question Who chose the type of stent?"|30 months||||Participants|||Count of Participants
2610970|NCT02046863|Primary|Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming|Symptoms were first assessed with the implanted pulse generator (IPG) turned off for at least 30 minutes to allow the after-effects of stimulation to wear off (baseline). Symptoms were measured again with the IPG turned on at a setting that both minimized the average severity of tremor and bradykinesia and minimized side effects. The Kinesia score rated symptom severity (0, normal; 4, most severe) in four categories: tremor, finger tapping speed, finger tapping amplitude, and finger tapping rhythm. Scores for the four motor symptoms were averaged and converted to percent change from baseline.|Within two days of standard clinical DBS programming session||||Percentage change||Standard Deviation|Mean
2610971|NCT02046772|Secondary|Time of Hospitalization|To see if the hospitalization time is shortened or not by the experimental treatment.|Up to 72 hours after the intervention||||participants|||Number
2610972|NCT02046772|Secondary|Number of Adverse Events|To assess if the experimental treatment causes less, equal or more adverse events than the comparator treatment.|Up to 72 hours from the intervention and the hopitalary stay and during the next 7 days after discharge||||participants|||Number
2611058|NCT02046200|Secondary|Ivermectin Pharmacokinetics: Time to Cmax (Tmax)|This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Time to Cmax (Tmax), measured in hours, provided below.|Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48|All randomized subjects included.|||hours||Standard Deviation|Mean
2610973|NCT02046772|Secondary|Greater and Earlier Mobilization Measured by Bromage Scale.|"To assess whether the administration of morphine chloride in addition to a low dose solution of local intradural anaesthetic (bupivacaine) improves the mobilization of the patients after surgery more than the single intradural administration of bupivacaine.~Total Score in the Bromage Scale goes from 1 to 5, where:~1: complete motor blocking - 2: capable to move the feet - 3: moves the feet and bends the knee - 4: raise the leg straight more or less than 30 degrees but no against resistance - 5: raise the leg straight more than 30 degrees against resistance (no motor blocking)"|During the first 24 hours after surgery and at the entry and exit of the resuscitation unit||||units on a scale||Standard Deviation|Mean
2610974|NCT02046772|Primary|Measurement of the Analgesic Effect After Surgery by VAS From 0 to 10, Where 0 is no Pain and 10 is the Worst Pain Imaginable.|To compare whether the addition of morphine chloride to a low dose solution of bupivacaine and improves the analgesic treatment than a single administration of bupivacaine.|Up to 72 hours from the end of the surgery in the hospital stay and during the next 7 days at home, after discharge||||units on a scale||Standard Deviation|Mean
2610975|NCT02046772|Primary|Measurement of Time to Start the Anaesthetic Effect|To compare whether the addition of morphine chloride to a low dose intradural solution of the local anaesthetic bupivacaine is as effective as an administration of a single dose of bupivacaine.|First 20 minutes between administration and beginning of surgery||||minutes||Standard Deviation|Mean
2610976|NCT02046616|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score|"FACIT-F consisted of 40 questions/statements assessing chronic illness therapy with special emphasis on fatigue over the past 7 days, with each item rated 0 (not at all) to 4 (very much). During score calculations, negatively-worded item scales (e.g., I have a lack of energy) were reversed so that higher scores indicated more favorable conditions. The total FACIT-F score was the sum of all item scores and ranged 0-160, and the brief FACIT-F score was the sum of 13 item scores and ranged 0-52, where higher scores indicate greater well-being. Change from baseline was averaged among all participants. Positive values indicate improvement in well-being."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||units on a scale||Standard Deviation|Mean
2610977|NCT02046616|Secondary|Compliance With Treatment According to Percentage of Injections Administered|Participants were provided with diary cards to record home injections. Compliance with treatment was calculated individually for each participant as the actual number of injections as a percentage of the planned number of injections (up to the point of discontinuation for those who discontinued study treatment prematurely) and then averaged among all participants.|Baseline up to Week 24|ITT Set|||percentage of injections||Standard Deviation|Mean
2610978|NCT02046616|Secondary|Change From Baseline in HAQ-DI Score|HAQ-DI consisted of 20 questions assessing ADLs in 8 domains (dress/groom, arise, eat, walk, reach, grip, hygiene) with each item rated 0 (no difficulty) to 3 (unable to do). The highest score recorded for any question in a domain determined the score for that domain, unless assistance was required. The total HAQ-DI score was the sum of domain scores divided by the number of domains answered/scored, for a single score range of 0-3, where higher scores indicate increased functional disability. Change from baseline was averaged among all participants. Negative values indicate improvement in ability to perform ADLs.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||units on a scale||Standard Deviation|Mean
2610979|NCT02046616|Secondary|Change From Baseline in Patient Global Assessment of RA-Related Pain According to VAS|PGA of RA-related pain was scored 0-100 mm on a VAS, where higher scores indicate greater perceived pain. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA-related pain.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||mm||Standard Deviation|Mean
2610980|NCT02046616|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity According to VAS|PGA of disease activity was scored 0-100 mm on a VAS, where higher scores indicate greater perceived disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||mm||Standard Deviation|Mean
2610981|NCT02046616|Secondary|Soluble Interleukin-6 Receptor (sIL-6R) Concentration|sIL-6R concentration was determined, averaged among all participants, and expressed in nanograms per milliliter (ng/mL).|Predose (30 minutes) at baseline; Weeks 12, 24; and FU Week 8 (up to 32 weeks overall)|ITT Set|||ng/mL||Standard Deviation|Mean
2610982|NCT02046616|Secondary|Tocilizumab Concentration|Tocilizumab concentration was determined, averaged among all participants, and expressed in micrograms per milliliter (mcg/mL).|Predose (30 minutes) at baseline; Weeks 12, 24; and FU Week 8 (up to 32 weeks overall)|ITT Set. The Analysis was conducted on those participants with quantifiable tocilizumab concentration at the specified assessment.|||mcg/mL||Standard Deviation|Mean
2610983|NCT02046616|Secondary|Number of Participants With Neutralizing Anti-Tocilizumab Antibodies|Participants were evaluated for the presence of anti-tocilizumab antibodies. Confirmatory assays were performed in the case of a positive screen assay result.|Baseline to FU Week 8 (up to 32 weeks overall)|ITT Set|||participants|||Number
2610984|NCT02046616|Secondary|Percentage of Participants With At Least One Adverse Event Leading to Dosage Modification|The percentage of participants with at least one adverse event leading to dose/frequency reduction or temporary dose hold was reported.|Baseline up to Week 24|ITT Set|||percentage of participants|||Number
2610985|NCT02046616|Secondary|Change From Baseline in SJC|SJC was taken as the number of swollen joints out of 28 assessed joints.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||swollen joints|Joints|Standard Deviation|Mean
2610986|NCT02046616|Secondary|Change From Baseline in TJC|TJC was taken as the number of tender joints out of 28 assessed joints.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||tender joints|Joints|Standard Deviation|Mean
2611472|NCT02043379|Secondary|Tumor Necrosis Factor Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|pre-operative through 48 hours post-operative||||pg/dL||Inter-Quartile Range|Median
2610987|NCT02046616|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI)|SDAI was derived as the sum of the following: TJC, SJC, PGA of disease activity, physician assessment of disease activity, and laboratory-derived C-reactive protein level. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 mm and rounded to the nearest cm on a VAS, where higher scores indicate greater perceived disease activity. The total SDAI score range was 0-86, where higher scores indicate increased disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||units on a scale||Standard Deviation|Mean
2610988|NCT02046616|Secondary|Change From Baseline in CDAI at Weeks 2, 4, 8, 16, 20, and 24|CDAI was derived as the sum of the following: TJC, SJC, PGA of disease activity, and physician assessment of disease activity. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 mm and rounded to the nearest cm on a VAS, where higher scores indicate greater perceived disease activity. The total CDAI score range was 0-76, where higher scores indicate increased disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.|Baseline and Weeks 2, 4, 8, 16, 20, 24|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||units on a scale||Standard Deviation|Mean
2610989|NCT02046616|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response|EULAR response was assessed by change from baseline and absolute DAS28-ESR score. EULAR response classification was as follows: Good (change >1.2 with absolute score </=3.2), Moderate (change >1.2 with absolute score >3.2 or change >0.6 with absolute score </=5.1), None (change </=0.6 or absolute score >5.1). DAS28-ESR was based on TJC, SJC, and PGA of disease activity, and laboratory-derived ESR. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA of disease activity was scored 0-100 mm on a VAS, where higher scores indicate greater perceived disease activity. The total DAS28-ESR score was transformed to a single score range of 0-10, where higher scores indicate increased disease activity. The percentage of participants meeting criteria for each level of EULAR response was reported.|Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set|||percentage of participants|||Number
2610990|NCT02046616|Secondary|Percentage of Participants With American College of Rheumatology (ACR) Response|ACR response was assessed on the basis of percent improvement (20% for ACR20, 50% for ACR50, 70% for ACR70) in both TJC and SJC as well as at least three of the following: physician assessment of disease activity, PGA of disease activity, PGA of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and either ESR or C-reactive protein level. TJC and SJC were taken as the number of tender and swollen joints, out of 68 and 66 assessed joints, respectively. PGA and physician assessments were scored 0-100 mm on a VAS, where higher scores indicate greater perceived disease activity or pain. HAQ-DI was scored using participant responses to 20 questions assessing activities of daily living (ADLs), with total score scale of 0-3, where higher scores indicate increased functional disability. The percentage of participants meeting criteria for each level of ACR response was reported.|Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set|||percentage of participants|||Number
2610991|NCT02046616|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28)-Erythrocyte Sedimentation Rate (ESR) Score|DAS28-ESR was based on TJC, SJC, PGA of disease activity, and laboratory-derived ESR. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA of disease activity was scored 0-100 mm on a VAS, where higher scores indicate greater perceived disease activity. The total DAS28-ESR score was transformed to a single score range of 0-10, where higher scores indicate increased disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 24|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||units on a scale||Standard Deviation|Mean
2610992|NCT02046616|Primary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12|CDAI was derived as the sum of the following: tender joint count (TJC), swollen joint count (SJC), participant global assessment (PGA) of disease activity, and physician assessment of disease activity. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 millimeters (mm) and rounded to the nearest centimeter (cm) on a visual analog scale (VAS), where higher scores indicate greater perceived disease activity. The total CDAI score range was 0-76, where higher scores indicate increased disease activity. Change from baseline was averaged among all participants. Negative values indicate improvement/reduction in RA disease activity.|Baseline, Week 12|ITT Set; only those patients who provided data at baseline and at least one post-baseline assessment were analyzed.|||units on a scale||Standard Deviation|Mean
2610993|NCT02046603|Secondary|Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs)||Baseline, Weeks 12 and 24, at early withdrawal (up to Week 52), and follow-up visit (8 weeks after last dose of tocilizumab, up to 60 weeks)|FAS population.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2610994|NCT02046603|Secondary|Serum Levels of Tocilizumab||Baseline, Weeks 12 and 24, at early withdrawal (up to Week 52), and follow-up visit (8 weeks after last dose of tocilizumab, up to 60 weeks)|FAS population.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
2610995|NCT02046603|Secondary|Number of Participants With Anti-Tocilizumab Antibodies||Baseline, Weeks 12 and 24, at early withdrawal (up to Week 52), and follow-up visit (8 weeks after last dose of tocilizumab, up to 60 weeks)|FAS population.|||participants|||Number
2610996|NCT02046603|Secondary|Number of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records|A diary card was provided to participants to record home injections. Participants were asked to return all empty drug supply boxes, unused pre-filled syringe, and diary cards to the clinic at each visit as a measure of drug accountability and participant compliance. A participant was considered compliant if the participant correctly administered all scheduled doses of SC tocilizumab during the assessment period.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)|FAS population.|||participants|||Number
2610997|NCT02046603|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score|The FACIT-F score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score).|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)|FAS population.|||units on a scale||Standard Deviation|Mean
2610998|NCT02046603|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)|FAS population.|||units on a scale||Standard Deviation|Mean
2610999|NCT02046603|Secondary|Patient Pain VAS Score|This assessment represents the participant's assessment of his/her current level of pain on a 100 mm horizontal VAS where 0 mm= no pain to 100 mm= unbearable pain.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)|FAS populations.|||mm||Standard Deviation|Mean
2611000|NCT02046603|Secondary|Patient Global Assessment of Disease Activity VAS Score|Patient global assessment of disease activity was measured on a 0 to 100 mm horizontal VAS where 0 mm=no disease activity and 100 mm=maximum disease activity.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)|FAS population.|||mm||Standard Deviation|Mean
2611001|NCT02046603|Secondary|Percentage of Methotrexate Adherence as Assessed by Methotrexate Adherence Questionnaire|Methotrexate adherence was determined from responses to the question 'Over the last 3 months you were prescribed 12 doses of methotrexate, how many (approximately) have you taken?' Adherence (%) was calculated as: (Approximate number of doses taken/12)*100.|Baseline, Weeks 12, 24, 36, 52, and at early withdrawal (up to Week 52)|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome. Results are provided for single arm as participants in “Tocilizumab Monotherapy” arm did not receive methotrexate.|||percentage of methotrexate adherence||Standard Deviation|Mean
2611002|NCT02046603|Secondary|Number of Participants With Non-Biologic DMARD/Corticosteroid Dose Reductions and/or Discontinuation|Results are reported for number of participants who had non-biologic DMARD/corticosteroid dose reductions and/or discontinuation by reasons for dose reductions or discontinuation (safety reasons, discomfort, lack of efficacy, other reasons, and unknown reasons). Participants may be included under more than one reason.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, at early withdrawal (up to Week 52), follow-up Week 4 (up to Week 56), and follow-up Week 8 (up to Week 60)|FAS population.|||participants|||Number
2611003|NCT02046603|Secondary|Number of Participants Who Achieved Remission as Defined by DAS28-ESR <2.6|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR <2.6 implied clinical remission.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)|FAS population.|||participants|||Number
2611004|NCT02046603|Secondary|Number of Participants Who Achieved Low Disease Activity as Defined by DAS28-ESR ≤3.2|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)|FAS population.|||participants|||Number
2611005|NCT02046603|Secondary|Change From Baseline in Total SJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of swollen joints compared to baseline indicates improvement.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||swollen joints||Standard Deviation|Mean
2611006|NCT02046603|Secondary|Percent Change From Baseline in Total SJC on 66 Joints at Week 52|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 66. A reduction in number of swollen joints compared to baseline indicates improvement. The outcome is reported as the percent change from baseline to end of treatment (52 weeks).|Baseline, Week 52|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||percent change||Standard Deviation|Mean
2611059|NCT02046200|Secondary|Ivermectin Pharmacokinetics: Peak Concentration (Cmax)|This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Maximum plasma concentration (Cmax), measured in ng/mL, provided below.|Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48|All randomized subjects included.|||ng/mL||Standard Deviation|Mean
2611007|NCT02046603|Secondary|Change From Baseline in Total TJC on 28 Joints at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of tender joints compared to baseline indicates improvement.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||tender joints||Standard Deviation|Mean
2611008|NCT02046603|Secondary|Percent Change From Baseline in Total TJC on 68 Joints at Week 52|Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 68. A reduction in number of tender joints compared to baseline indicates improvement. The outcome is reported as the percent change from baseline to end of treatment (52 weeks).|Baseline, Week 52|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||percent change||Standard Deviation|Mean
2611009|NCT02046603|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal|The CDAI is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician's global assessment of disease activity assessed on 0-10 cm VAS (0 cm= no disease activity and 10 cm= worst disease activity). CDAI total score = 0-76. CDAI ≤2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
2611010|NCT02046603|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at Early Withdrawal|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician global assessment of disease activity assessed on 0-10 centimeter (cm) VAS (0 cm= no disease activity and 10 cm= worst disease activity), and CRP in milligrams per liter (mg/L). SDAI total score = 0-86. SDAI ≤3.3 indicates clinical remission, >3.3 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
2611011|NCT02046603|Secondary|Number of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR|DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). DAS28-ESR scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. The DAS28-ESR based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1. Participants with change from baseline >0.6 to ≤1.2 with a DAS28 score >5.1, or any score with change from baseline ≤0.6, were assessed as non-responders.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)|FAS population.|||participants|||Number
2611012|NCT02046603|Secondary|Number of Participants Achieving an ACR70 Response|A participant had an ACR70 response if there was at least a 70% improvement, ie, reduction from Baseline, in TJC (68 joints) and SJC (66 joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0 mm=no pain to 100 mm=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, averaged to 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR).|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)|FAS population.|||participants|||Number
2611013|NCT02046603|Secondary|Number of Participants Achieving an ACR50 Response|A participant had an ACR50 response if there was at least a 50% improvement, ie, reduction from Baseline, in TJC (68 joints) and SJC (66 joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0 mm=no pain to 100 mm=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, averaged to 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR).|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)|FAS population.|||participants|||Number
2611014|NCT02046603|Secondary|Number of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response|A participant had an ACR20 response if there was at least a 20 percent (%) improvement, ie, reduction from Baseline, in TJC (68 joints) and SJC (66 joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0 mm=no pain to 100 mm=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, averaged to 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either C-reactive protein [CRP] or ESR).|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, and at early withdrawal (up to Week 52)|FAS population.|||participants|||Number
2611015|NCT02046603|Primary|Change From Baseline in DAS28-ESR at Early Withdrawal|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, >3.2 to ≤5.1 implied moderate disease activity, >5.1 implied high/severe disease, and <2.6 implied clinical remission.|Baseline, early withdrawal (up to Week 52)|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
2611016|NCT02046603|Primary|Change From Baseline in DAS28-ESR at Week 52|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, >3.2 to ≤5.1 implied moderate disease activity, >5.1 implied high/severe disease, and <2.6 implied clinical remission.|Baseline, Week 52|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
2611017|NCT02046603|Primary|Change From Baseline in DAS28-ESR at Week 48|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, >3.2 to ≤5.1 implied moderate disease activity, >5.1 implied high/severe disease, and <2.6 implied clinical remission.|Baseline, Week 48|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
2611018|NCT02046603|Primary|Change From Baseline in DAS28-ESR at Week 44|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, >3.2 to ≤5.1 implied moderate disease activity, >5.1 implied high/severe disease, and <2.6 implied clinical remission.|Baseline, Week 44|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
2611019|NCT02046603|Primary|Change From Baseline in DAS28-ESR at Week 40|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, >3.2 to ≤5.1 implied moderate disease activity, >5.1 implied high/severe disease, and <2.6 implied clinical remission.|Baseline, Week 40|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
2611020|NCT02046603|Primary|Change From Baseline in DAS28-ESR at Week 36|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, >3.2 to ≤5.1 implied moderate disease activity, >5.1 implied high/severe disease, and <2.6 implied clinical remission.|Baseline, Week 36|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
2611021|NCT02046603|Primary|Change From Baseline in DAS28-ESR at Week 32|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, >3.2 to ≤5.1 implied moderate disease activity, >5.1 implied high/severe disease, and <2.6 implied clinical remission.|Baseline, Week 32|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
2611022|NCT02046603|Primary|Change From Baseline in DAS28-ESR at Week 28|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, >3.2 to ≤5.1 implied moderate disease activity, >5.1 implied high/severe disease, and <2.6 implied clinical remission.|Baseline, Week 28|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
2611023|NCT02046603|Primary|Change From Baseline in DAS28-ESR at Week 24|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, >3.2 to ≤5.1 implied moderate disease activity, >5.1 implied high/severe disease, and <2.6 implied clinical remission.|Baseline, Week 24|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
2611024|NCT02046603|Primary|Change From Baseline in DAS28-ESR at Week 20|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, >3.2 to ≤5.1 implied moderate disease activity, >5.1 implied high/severe disease, and <2.6 implied clinical remission.|Baseline, Week 20|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
2611025|NCT02046603|Primary|Change From Baseline in DAS28-ESR at Week 16|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, >3.2 to ≤5.1 implied moderate disease activity, >5.1 implied high/severe disease, and <2.6 implied clinical remission.|Baseline, Week 16|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
2611026|NCT02046603|Primary|Change From Baseline in DAS28-ESR at Week 12|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, >3.2 to ≤5.1 implied moderate disease activity, >5.1 implied high/severe disease, and <2.6 implied clinical remission.|Baseline, Week 12|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
2611027|NCT02046603|Primary|Change From Baseline in DAS28-ESR at Week 8|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, >3.2 to ≤5.1 implied moderate disease activity, >5.1 implied high/severe disease, and <2.6 implied clinical remission.|Baseline, Week 8|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
2611028|NCT02046603|Primary|Change From Baseline in DAS28-ESR at Week 4|DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR ≥2.6 to ≤3.2 implied low disease activity, >3.2 to ≤5.1 implied moderate disease activity, >5.1 implied high/severe disease, and <2.6 implied clinical remission.|Baseline, Week 4|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
2611029|NCT02046603|Primary|Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 2|DAS28 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR; millimeters per hour [mm/hour]), and patient's global assessment of disease activity (measured on a 0 to 100 mm Visual Analog Scale [VAS] where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR greater than or equal to (≥) 2.6 to less than or equal to (≤) 3.2 implied low disease activity, greater than (>) 3.2 to ≤5.1 implied moderate disease activity, >5.1 implied high/severe disease, and less than (<) 2.6 implied clinical remission.|Baseline, Week 2|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||units on a scale||Standard Deviation|Mean
2611030|NCT02046564|Secondary|The Mean Change From Baseline in the Self-rating Version of Montgomery-Åsberg Depression Rating Scale (MADRS-S) Total Score|The MADRS-S is a patient-reported scale based on MADRS, administered to evaluate the level of depression. This scale consists of 9 items assessing patients' mood, feelings of unease, sleep, appetite, ability to concentrate, initiative, emotional involvement, pessimism and zest for life. Each item is scored from 0 to 3, with higher scores indicating worse condition. Summed subscales are combined to compute a total score. Total score ranges from 0 to 27, with higher score indicating worse condition.|8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])||||units on a scale||Standard Error|Mean
2611031|NCT02046564|Secondary|The Mean Change From Baseline in the Apathy Scale (AS) Total Score|The AS consists of 14 items. Items 1-8 are scored as follows: 3= Not at all, 2= Slightly, 1= Some, 0= A lot. Items 9-14 are scored as follows: 0= Not at all, 1= Slightly, 2= Some, 3= A lot. Total score ranges from 0-42, with higher score indicating worse condition.|8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])||||units on a scale||Standard Error|Mean
2611032|NCT02046564|Secondary|The Mean Change From Baseline in the Social Adaptation Self-evaluation Scale (SASS) Total Score|The SASS is a self-rating scale which assesses the social motivation and behavior in participants with depression. The SASS consists of 21 items covering the different aspects of social interactions, global social attitude, and self-perception. Each item is scored from 0 to 3, with higher scores indicating better condition.|8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])||||units on a scale||Standard Error|Mean
2611473|NCT02043379|Secondary|Interleukin-8 Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|pre-operative through 48 hours post-operative||||pg/dL||Inter-Quartile Range|Median
2611033|NCT02046564|Secondary|The Mean Change From Baseline in the Hamilton Depression Rating Scale 17 (HAM-D17) Total Score|"The HAM-D is a clinician-rated scale which evaluates the level of depression. The HAM-D consists of 17 items such as depression mood, feeling of guilt, suicide, insomnia, work and activities, retardation, and so on.~Each item is scored from 0 to 2, 3 or 4, with higher scores indicating worse condition. Summed subscales are combined to compute a total score. Total score ranges from 0 to 52, with higher score indicating worse condition."|8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])||||units on a scale||Standard Error|Mean
2611034|NCT02046564|Secondary|The Mean Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S)|The CGI-S Scale is a clinician-rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition.|8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])||||units on a scale||Standard Error|Mean
2611035|NCT02046564|Secondary|The Clinical Global Impression - Improvement (CGI-I) Improvement Rate|The CGI-I Scale is a clinician-rated scale which assesses the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition. CGI-I Improvement Rate is the percentage of subjects whose CGI-I score is 1 or 2.|6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])||||percentage of participants|||Number
2611036|NCT02046564|Secondary|The Montgomery-Åsberg Depression Rating Scale (MADRS) Remission Rate|"The MADRS is a clinician-rated scale which evaluates the level of depression. The MADRS consists of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item is scored from 0 to 6, with higher scores indicating worse condition.~MADRS Remission Rate is the percentage of subjects who achieved a decrease in the MADRS total score by 50% or more and whose MADRS total score is 10 points or less."|8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])||||percentage of participants|||Number
2611037|NCT02046564|Secondary|The Montgomery-Åsberg Depression Rating Scale (MADRS) Response Rate|"The MADRS is a clinician-rated scale which evaluates the level of depression. The MADRS consists of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item is scored from 0 to 6, with higher scores indicating worse condition.~MADRS Response Rate is the percentage of subjects who achieved a decrease in the MADRS total score by 50% or more."|8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])||||percentage of participants|||Number
2611038|NCT02046564|Primary|The Mean Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score|The MADRS is a clinician-rated scale which evaluates the level of depression. The MADRS consists of 10 items assessing apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thought. Each item is scored from 0 to 6, with higher scores indicating worse condition.Summed subscales are combined to compute a total score. Total score ranges from 0 to 60, with higher score indicating worse condition.|8 weeks after the start of the sertraline treatment period (Baseline), 6 weeks after the start of the double-blind period (Last Observation Carried Forward [LOCF])||||units on a scale||Standard Error|Mean
2611039|NCT02046525|Primary|Number of Participants With Restoration of Microbial Community Composition to the Pre-antibiotic State by 90 Days Post FMT or Saline Enema|Restoration of microbial community composition (bacterial taxa that are present) and structure (abundance of taxa) to the subject's state prior to antimicrobial exposure. Bacterial taxa are the types/strains of bacteria found in the microbiome.|90 days after enrollment||||Participants|||Count of Participants
2611040|NCT02046382|Other Pre-specified|Total Amount of Ibuprofen During Inpatient Stay|Patients will have access to ibuprofen for mild to moderate pain. The amount consumed during inpatient stay will be collected.|2-7 days||||mg||Standard Deviation|Mean
2611041|NCT02046382|Secondary|Length of Stay|Length of hospital stay (admission to discharge) will be collected.|2-7 days||||hours||Inter-Quartile Range|Median
2611042|NCT02046382|Secondary|Number of Participants With Narcotic Associated Side Effects|Only outcome for nausea/emesis is reported.|2-7 days||||Participants|||Count of Participants
2611043|NCT02046382|Primary|Total Oxycodone (mg)|Total oxycodone (mg) for breakthrough pain during inpatient stay|approximately 2 - 7 days||||mg||Standard Deviation|Mean
2611044|NCT02046369|Secondary|Change From Baseline in Clinical Global Impressions-Bipolar-Severity (CGI-BP-S) Depression Score|Change from baseline in Clinical Global Impressions-Bipolar-Severity (CGI-BP-S) depression score changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures.The CGI-BP-S is a three-question clinician-rated assessment of the subject's current illness state (depression, mania, and overall) using a 7-point scale (1(normal, not ill) to 7 (very severely ill)) for each question, where a higher score is associated with greater illness severity.|baseline and week 6|the ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable|||units on a scale||Standard Deviation|Least Squares Mean
2611060|NCT02046200|Primary|Adverse Effects|Adverse effects will be monitored to determine the safe of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl) using the Systematic Assessment for Treatment Emergent Effects (SAFTEE). The SAFTEE is a 24-item checklist in which the participant can identify whether a symptom is present (yes/no), its severity (mild, moderate, severe) and whether it was caused by the medication (yes/no). Data below represents a count of individual adverse effects reported on the SAFTEE during the alcohol infusion.|During alcohol infusion at BrAC = 0.00, 0.04, 0.08 g/dl|All randomized subjects included.|||adverse effect count|||Number
2611045|NCT02046369|Secondary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) Score as Compared to Placebo.|ADHD-RS total score: changes from baseline over time -ANCOVA-LS Mean and SE for change from baseline are based on ANCOVA. The Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q is a 15-item self-report measure of the degree of enjoyment and satisfaction in various areas of daily living, based on the content of the Short From of the Q-LES-Q. Each item is rated on a 5-point scale, ranging from 1 (very poor) to 5 (very good). The first 14 items are the same as the General Activities section of the regular Q-LES-Q form and are used to compute the raw score. The PQ-LES-Q-SF percentage maximum possible score is calculated as follows:% Max = 100 × (Raw Score - Minimum Score) / (Maximum Score - Minimum Score),where the Minimum Score equals 14 and the Maximum Score equals 70, and the % maximum possible score can range from 0% to 100%. Higher scores indicate better quality of life.|baseline and week 6|The ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable|||units on a scale||Standard Deviation|Least Squares Mean
2611046|NCT02046369|Secondary|Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score as Compared to Placebo.|CGAS Score: changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures|baseline and week 6|the ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable|||units on a scale||Standard Deviation|Least Squares Mean
2611047|NCT02046369|Secondary|Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Score as Compared to Placebo.|"PQ-LES-Q percentage maximum possible score: changes from baseline over time - mixed model for repeated measures~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures"|baseline|the ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment on any efficacy variable|||units on a scale||Standard Deviation|Least Squares Mean
2611048|NCT02046369|Secondary|Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Score as Compared to Placebo.|PARS score: changes from baseline over time - mixed model for repeated measures-LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures.The PARS is a clinician-rated instrument for assessing over time the severity of anxiety symptoms associated with common DSM-IV anxiety disorders in children ages 6‑17 years. The PARS is administered separately to the subject and to the caregiver. The instrument has 2 sections. The first section includes a 50-item symptom checklist, which the clinician rates as present or absent during the past week. The second section is comprised of 7 severity impairment items reflecting the severity/impairment of all symptoms endorsed in Section 1 of the PARS (during the past week). Each question is answered on a 0-5 Likert scale (0 for none, and 1-5 for minimal to extreme) with alternative responses of 8=Not Applicable and 9=Does Not Know. The PAR total score over all 7 questions ranges in value from 0 to 35.|baseline and week 6|The ITT population included all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable|||units on a scale||Standard Deviation|Least Squares Mean
2611049|NCT02046369|Primary|Change in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score as Compared to Placebo From Double-Blind Baseline to Week 6 (Day 43) Baseline|"CDRS-R total score: changes from baseline over time - mixed model for repeated measures. LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures.~The CDRS-R total score ranges from 17-113. In general, higher values of CDRS-R total score represent greater severity of illness.~The primary efficacy endpoint will be assessed between the placebo and treatment group."|baseline, Week 6|The ITT population includes all randomized subjects who received at least one dose of study medication and had at least one post-baseline assessment in any efficacy variable|||units on a scale||Standard Deviation|Least Squares Mean
2611050|NCT02046317|Primary|Patient Pain Level|Pain level will be measured on a numeric visual analogue scale of 0-10 with 0 being no pain and 10 being the worst pain ever.|60 minutes after initial femoral block||||units on a scale||Standard Deviation|Mean
2611051|NCT02046317|Primary|Patient Pain Level|Pain level will be measured on a numeric visual analogue scale of 0-10 with 0 being no pain and 10 being the worst pain ever.|baseline||||units on a scale||Standard Deviation|Mean
2611052|NCT02046265|Primary|Human Papilloma Virus (HPV) Vaccine #1 Acceptance||For each participant, at end of first study visit. Will assess until all subjects enrolled in study.|All participants in the analysis were eligible to recieve the HPV vaccine.|||Participants|||Count of Participants
2611053|NCT02046226|Secondary|Incidence of Complete Wound Closure|number of wounds undergoing complete reepithelialization without drainage or dressing requirements, maintained for at least 2 weeks.|3 months|Study subjects were not available to provide data when the secondary outcome was to be reported, and thus there are no secondary outcome data to report.||||||
2611054|NCT02046226|Primary|Rate of Wound Healing|Percentage reduction in target wound area (length x width).|3 months|Study subjects were not available to provide data when the primary outcome was to be reported, and thus there are no primary outcome data to report.||||||
2611055|NCT02046200|Secondary|Stress-induced Alcohol Craving|Alcohol Urge Questionnaire (AUQ)|pre-post exposure to an imaginal stress script|The stress paradigm (pre-post exposure to an imaginal stress script) was not implemented from the outset of the study due to feasibility reasons. In particular, the investigators were concerned that the timing of the stress exposure might contaminate the effects of the alcohol administration.||||||
2611056|NCT02046200|Secondary|Ivermectin Pharmacokinetics: Half-life (T1/2)|This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Half-life of ivermectin (T1/2), measured in hours, provided below.|Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48||||hours||Standard Deviation|Mean
2611057|NCT02046200|Secondary|Ivermectin Pharmacokinetics: Area Under the Time-concentration Curve (AUC)|This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Area under the time-concentration curve (AUC) from 0 to 48 hours after IVM administration, provided below.|Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48|All randomized subjects included.|||ng*h/mL||Standard Deviation|Mean
2611061|NCT02046200|Primary|Cue-induced Craving Using the Alcohol Urge Questionnaire (AUQ)|Cue-induced craving will be measured using the Alcohol Urge Questionnaire (AUQ), which consists of 8 items associated with urge to drink alcohol, rated on a 7 point scale (0 = strongly disagree, 6 = strongly agree). Item scores were averaged and the total score also ranges from 0-6.|6 hours post-medication administration||||scores on a scale||Standard Deviation|Mean
2611062|NCT02046200|Primary|Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Sedative Subscale|Subjective effects of alcohol will be measured using the Biphasic Alcohol Effects Scale (BAES) , which consists of 14 items designed to capture the stimulant and sedative effects of alcohol, each rated on an 11-point scale (0 = not at all, 10 = extremely). The total score for the Sedative Subscale ranges from 0 to 70. Mean scores across subjects are reported below.|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.|||scores on a scale||Standard Deviation|Mean
2611063|NCT02046200|Primary|Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Stimulant Subscale|Subjective effects of alcohol will be measured using the Biphasic Alcohol Effects Scale (BAES) , which consists of 14 items designed to capture the stimulant and sedative effects of alcohol, each rated on an 11-point scale (0 = not at all, 10 = extremely). The total score for the Stimulant Subscale ranges from 0 to 70. Mean scores across all subjects are reported below.|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.|||scores on a scale||Standard Deviation|Mean
2611064|NCT02046200|Primary|"Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - High Subscale"|"Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question Are you high? was rated on an 11 point scale from 0 to 10 (higher values represent more effects)."|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.|||scores on a scale||Standard Deviation|Mean
2611065|NCT02046200|Primary|"Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - More Subscale"|"Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question Would you like more of the drug right now? was rated on an 11 point scale from 0 to 10 (higher values represent more effects)."|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.|||scores on a scale||Standard Deviation|Mean
2611066|NCT02046200|Primary|"Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - Like Subscale"|"Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question Do you like the effects you are feeling right now? was rated on an 11 point scale from 0 to 10 (higher values represent more effects)."|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.|||scores on a scale||Standard Deviation|Mean
2611067|NCT02046200|Primary|"Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - Feel Subscale"|"Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question Do you feel any drug effects? was rated on an 11 point scale from 0 to 10 (higher values represent more effects)."|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.|||scores on a scale||Standard Deviation|Mean
2611068|NCT02046200|Primary|Subjective Effects of Alcohol Using the Alcohol Urge Questionnaire (AUQ)|Subjective effects of alcohol will be measured using the Alcohol Urge Questionnaire (AUQ), which consists of 8 items associated with urge to drink alcohol, rated on a 7 point scale (1 = strongly disagree, 7 = strongly agree).|During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.|All randomized subjects included.|||scores on a scale||Standard Deviation|Mean
2611069|NCT02046200|Primary|Diastolic Blood Pressure|"Blood pressure (measured in mmHg) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl).~Blood pressure is measured at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-medication administration; and during alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl. During the infusion, the times for collecting BP will vary based on how long it takes participants to reach the targeted BrACs."|Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl|All randomized subjects included.|||mmHg||Standard Deviation|Mean
2611070|NCT02046200|Primary|Systolic Blood Pressure|"Blood pressure (measured in mmHg) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl).~Blood pressure is measured at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-medication administration; and during alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl. During the infusion, the times for collecting BP will vary based on how long it takes participants to reach the targeted BrACs."|Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl|All randomized subjects included.|||mmHg||Standard Deviation|Mean
2611071|NCT02046200|Primary|Heart Rate|"Heart rate (measured in beats per minute; BPM) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl).~During the infusion, the times for collecting HR will vary based on how long it takes participants to reach the targeted BrACs."|Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl|All randomized subjects included.|||BPM||Standard Deviation|Mean
2611110|NCT02046070|Secondary|Time to Progression (TTP) in RRMM Participants|TTP is defined as the time from the date of first dose of study treatment to the date of first documentation of disease progression.|Up to 45 months|Safety Population was defined as all participants who received at least 1 dose of any study drug. Participants without documentation of PD were censored at the date of last response assessment that is SD or better prior to the date of the alternative therapy.|||months||95% Confidence Interval|Median
2611072|NCT02046148|Secondary|Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Median, Minimum and Maximum)|Long-term developmental outcome assessed by Bayley Scales of Infant and Toddler Development 3rd edition Screening Test (PsychCorp). The screening test measured three domains: cognitive, language (receptive vs expressive communication), and motor (fine vs gross). Scaled scores range from 1 to 19 with a mean of 10 and a standard deviation of 3. The scores were summarized by reporting the median, minimum and maximum.|At Day 180 of age|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.|||Sores on a scale||Full Range|Median
2611073|NCT02046148|Secondary|Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Mean - Standard Deviation)|Long-term developmental outcome assessed by Bayley Scales of Infant and Toddler Development 3rd edition Screening Test (PsychCorp). The screening test measured three domains: cognitive, language (receptive vs expressive communication), and motor (fine vs gross). Scaled scores range from 1 to 19 with a mean of 10 and a standard deviation of 3. The scores were summarized by reporting the mean and standard deviation.|At Day 180 of age|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.|||Scores on a scale||Standard Deviation|Mean
2611074|NCT02046148|Secondary|Infants Apgar Scores (Median, Minimum and Maximum)|Apgar (Appearance, Pulse, Grimace response, Activity and Respiration) test to evaluate the new-born's physical condition. Apgar scores between 0 and 10 (highest score possible). If 1 and 5 minutes Apgar score were normal, 10 minutes Apgar score might not be required.|At 1, 5 and 10 minutes|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.|||Scores on a scale||Full Range|Median
2611075|NCT02046148|Secondary|Infants Apgar Scores (Mean - Standard Deviation)|Apgar (Appearance, Pulse, Grimace response, Activity and Respiration) test to evaluate the new-born's physical condition. Apgar score between 0 and 10 (highest score possible). If 1 and 5 minutes Apgar score were normal, 10 minutes Apgar score might not be required.|At 1, 5 and 10 minutes|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.|||Scores on a scale||Standard Deviation|Mean
2611076|NCT02046148|Secondary|Birth Length and Head Circumference of Infants (Median - Minimum and Maximum)|Length and head circumference at birth were summarized by reporting the median and minimum and maximum|At birth|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.|||Centimeter||Full Range|Median
2611077|NCT02046148|Secondary|Birth Length and Head Circumference of Infants (Mean - Standard Deviation)|Length and head circumference at birth were summarized by reporting the mean and standard deviation.|At Birth|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.|||Centimeter||Standard Deviation|Mean
2611078|NCT02046148|Secondary|Birth Weight of Infants (Median, Minimum and Maximum)|Weight at birth was summarized by reporting the median and the minimum and maximum.|At Birth|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.|||Kilogram||Full Range|Median
2611079|NCT02046148|Secondary|Birth Weight of Infants (Mean-Standard Deviation)|Weight at birth was summarized by reporting the mean and standard deviation,|At Birth|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination.|||Kilogram||Standard Deviation|Mean
2611080|NCT02046148|Secondary|Percentage of Infants With SAEs, Unsolicited MAEs and AEs Leading to Study Withdrawal|An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. An MAE is defined as an adverse event that leads to an unscheduled visit to a healthcare practitioner.|From Birth through Day 180 of age|Infants born to screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on unsolicited adverse events.|||Percentage of Infant Subjects|||Number
2611081|NCT02046148|Secondary|Percentage of Maternal Subjects With SAEs, Unsolicited MAEs and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal)|An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. An MAE is defined as an adverse event that leads to an unscheduled visit to a healthcare practitioner.|From Study Day 32 through Day 180 postpartum|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on unsolicited adverse events.|||Percentage of Maternal Subjects|||Number
2611474|NCT02043379|Secondary|Interleukin-6 Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|pre-operative through 48 hours post-operative||||pg/mL||Inter-Quartile Range|Median
2611082|NCT02046148|Secondary|Percentage of Maternal Subjects With Serious Adverse Events (SAEs), Unsolicited Medically Attended AEs (MAEs) and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal)|An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; life-threatening; that does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity; congenital anomaly/or birth defect; any important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgement, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. An MAE is defined as an adverse event that leads to an unscheduled visit to a healthcare practitioner.|From Study Day 1 through Study Day 31|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on unsolicited adverse events.|||Percentage of Maternal Subjects|||Number
2611083|NCT02046148|Secondary|Percentage of Maternal Subjects With Any Unsolicited AEs|An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. This definition includes inter-current illnesses or injuries and exacerbation of pre-existing conditions.|From Study Day 1 through Study Day 31|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on unsolicited adverse events.|||Percentage of Maternal Subjects|||Number
2611084|NCT02046148|Secondary|Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7|Percentage and frequency of maternal subjects with solicited local and solicited systemic adverse events up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.|During Study Days 1-7 (from 6 hours through Day 7 post-vaccination)|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on post-vaccination local or systemic adverse events.|||Percentage of Maternal Subjects|||Number
2611085|NCT02046148|Secondary|Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 4-7|Percentage and frequency of maternal subjects with solicited local and solicited systemic AEs up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.|During Study Days 4-7|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on post-vaccination local or systemic adverse events.|||Percentage of Maternal Subjects|||Number
2611086|NCT02046148|Secondary|Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3|Percentage and frequency of maternal subjects with solicited local and solicited systemic AEs up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.|During Study Days 1-3 (from 6 hours through Day 3 post-vaccination)|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on post-vaccination local or systemic adverse events.|||Percentage of Maternal Subjects|||Number
2611087|NCT02046148|Secondary|Percentage of Maternal Subjects With Solicited Local and Solicited Systemic Adverse Events (AEs) up to 30 Minutes|Percentage and frequency of maternal subjects with solicited local and solicited systemic AEs up to Study Day 7 and calculated for four time intervals after vaccination: 30 minutes, Study Days 1-3 (without 30 min), Study Days 4-7, Study Days 1-7 (without 30 min). Threshold for Ecchymosis, Erythema, Swelling and Induration: Grade 0 (<25 mm), Any (≥ 25 mm). Systemic fever includes subjects with body temperature ≥ 38 °C irrespective of route of measurement.|Up to 30 minutes post-vaccination|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID and who received a study vaccination and who provided data on post-vaccination local or systemic adverse events.|||Percentage of Maternal Subjects|||Number
2611088|NCT02046148|Secondary|Ratio of GBS IgG Antibody Levels - Serotype III in Infant Serum Relative to Maternal Serum at the Time of Delivery|To evaluate the relationship of serotype-specific III GBS IgG antibody levels (anti-III) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.|At Delivery|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.|||Ratio||95% Confidence Interval|Geometric Mean
2611111|NCT02046070|Secondary|Duration of Response (DOR) in RRMM Participants|DOR is defined as the time from the date of first documentation of a confirmed PR or better to the date of first documented PD up to the alternative therapy.|Up to 45 months|Participants from the Response Evaluable Population, participants who received at least 2 of the 3 ixazomib doses during Cycle 1, had measurable disease at Baseline and at least 1 postbaseline response assessment, who responded. Responders without PD were censored at the date of SD or better prior to the date of the alternative therapy.|||months||95% Confidence Interval|Median
2611089|NCT02046148|Secondary|Ratio of GBS IgG Antibody Levels - Serotype Ib in Infant Serum Relative to Maternal Serum at the Time of Delivery|To evaluate the relationship of serotype-specific Ib GBS IgG antibody levels (anti-Ib) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.|At Delivery|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.|||Ratio||95% Confidence Interval|Geometric Mean
2611090|NCT02046148|Secondary|Ratio of GBS IgG Antibody Levels - Serotype Ia in Infant Serum Relative to Maternal Serum at the Time of Delivery|To evaluate the relationship of serotype-specific Ia GBS IgG antibody levels (anti-Ia) in the infant serum to the GBS IgG antibody levels in the maternal serum at the time of delivery/birth. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).|At Delivery|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.|||Ratio||95% Confidence Interval|Geometric Mean
2611091|NCT02046148|Primary|Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype III, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum|Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (III) GBS serum IgG antibody concentrations (anti-III) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.|At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.|||Ratio||95% Confidence Interval|Geometric Mean
2611092|NCT02046148|Primary|Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype Ib, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum|Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (Ib) GBS serum IgG antibody concentrations (anti-Ib) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.|At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.|||Ratio||95% Confidence Interval|Geometric Mean
2611093|NCT02046148|Primary|Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype Ia, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum|Geometric Mean Ratio relative to pre-vaccination (Day 1) of serotype-specific (Ia) GBS serum IgG antibody concentrations (anti-Ia) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).|At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.|||Ratio||95% Confidence Interval|Geometric Mean
2611094|NCT02046148|Primary|Concentration of Serotype III GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum|To evaluate serotype-specific (III) GBS serum IgG antibody levels (anti-III) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.|At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.|||µg/mL||95% Confidence Interval|Geometric Mean
2611095|NCT02046148|Primary|Concentration of Serotype Ib GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum|To evaluate serotype-specific (Ib) GBS serum IgG antibody levels (anti-Ib) in maternal subjects. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.|At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.|||µg/mL||95% Confidence Interval|Geometric Mean
2611096|NCT02046148|Primary|Concentration of Serotype Ia GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum|To evaluate serotype-specific (Ia) GBS serum IgG antibody levels (anti-Ia) in maternal subjects. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).|At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.|||µg/mL||95% Confidence Interval|Geometric Mean
2611361|NCT02044510|Secondary|3 Day Voiding Diary|The 3 day voiding diary is a simple patient maintained record of fluid intake, voided volume and incontinence episodes. This will be used to assess number of episodes of urgency incontinence, urinary frequency, longest time between voids, functional capacity, and mean voided volume|10 weeks|||||||
2611097|NCT02046148|Primary|Concentration of Serotype III GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age|To evaluate serotype-specific III GBS serum IgG antibody levels (anti-III) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay.|At Birth, Day 42 and Day 90|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.|||µg/mL||95% Confidence Interval|Geometric Mean
2611098|NCT02046148|Primary|Concentration of Serotype Ib GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age|To evaluate serotype-specific Ib GBS serum IgG antibody levels (anti-Ib) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. As the singleton ELISA was no longer in use at the time of serotypes Ib and III testing, results for both serotypes were tested using multiplex immunoassay|At Birth, Day 42 and Day 90|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.|||µg/mL||95% Confidence Interval|Geometric Mean
2611099|NCT02046148|Primary|Concentration of Serotype Ia GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age|To evaluate serotype-specific Ia GBS serum IgG antibody levels (anti-Ia) in infants born to maternal subjects receiving the GBS trivalent vaccine, as measured at birth, Day 42 and Day 90 of age. Antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL).|At Birth, Day 42 and Day 90|All screened subjects who signed informed consent form, provided demographic data and/or baseline screening assessments, were randomized and assigned a study subject ID, who correctly received the study vaccine, who had no major protocol deviation, and who provided at least one evaluable serum sample at the relevant time points.|||µg/mL||95% Confidence Interval|Geometric Mean
2611100|NCT02046122|Secondary|Rate of Hematopoietic Recovery|Hematopoietic recovery as measured by the date of the first of three consecutive laboratory values where the absolute neutrophil count (ANC) ≥ 500/μl , the date of the first of three consecutive laboratory values obtained on different days where the platelet count was > 20,000/μl without transfusion.|2 years after completion of therapy|||||||
2611101|NCT02046122|Secondary|Rate of Immune Recovery|Immune recovery determined by measurements of cytokine profiles, lymphocyte and natural killer (NK) enumeration and flow-based assays, measured prior to induction, prior to each round of consolidation, 8 weeks after the last cycle of consolidation, and every 3 months after treatment for up to 2 years|2 years after completing therapy|||||||
2611102|NCT02046122|Secondary|Rate of Efficacy|Efficacy as measured by the percentage of subjects with a complete remission.|2 years after completing therapy|||||||
2611103|NCT02046122|Secondary|Percentage of Subjects With Unacceptable Toxicity|Grade IV CTCAE toxicity attributable to DLI (e.g. infusion reaction, as opposed to Grade IV CTCAE toxicity from chemotherapy) and lasting >7 days, Grade III or IV aGVHD of the gut or liver or Grade IV aGVHD of the skin lasting > 7 days, or death|8 weeks after the last cell infusion||||percentage of participants|||Number
2611104|NCT02046122|Secondary|Percentage of Subjects With Acute GVHD|Grade III or IV aGVHD of the gut or liver or Grade IV aGVHD of the skin lasting > 7 days|8 weeks after last cell infusion||||percentage of participants|||Number
2611105|NCT02046122|Secondary|Overall Survival|Overall survival 2 years after completing adoptive transfer therapy|2 years after completing therapy|||||||
2611106|NCT02046122|Secondary|Disease Free Survival|1 year disease free survival rate following adoptive transfer|one year following adoptive transfer|Data not collected on one subject.|||Participants|||Count of Participants
2611107|NCT02046122|Primary|Number of Subjects With Unacceptable Toxicity|"Unacceptable toxicity is defined as:~i. Grade III or IV acute GVHD (aGVHD) of the gut or liver or Grade IV aGVHD of the skin lasting > 7 days;~ii. Grade IV Common Terminology Criteria for Adverse Events (CTCAE) toxicity attributable to DLI (e.g. infusion reaction, as opposed to Grade IV CTCAE toxicity from chemotherapy) and lasting >7 days~iii. Treatment-related mortality (TRM)"|up to 8 weeks after last cell infusion||||Participants|||Count of Participants
2611108|NCT02046070|Secondary|Change From Baseline in EORTC Quality of Life Questionnaire (QLQ-C30) in RRMM Participants|EORTC QLQ-C30 is a patient completed 30 item questionnaire that consists of 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The patient evaluates their health status over the previous week. There are 28 questions answered on a 4-point scale where1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best). All of the scales and single-item measures are transformed to a score:0 to 100. For functioning scales and global QOL higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement).|Baseline (Day 1 of Cycle 1), Day 1 of End of Treatment (EOT) (Up to 45 months)|Participants from the Safety Population, defined as all participants who received at least 1 dose of any study drug, with data available for analysis.|||score on a scale||Standard Deviation|Mean
2611109|NCT02046070|Secondary|Progression Free Survival (PFS) in RRMM Participants|PFS is defined as the time from the date of first dose of study treatment to the date of the first documented disease progression or death.|Up to 45 months|Safety Population was defined as all participants who received at least 1 dose of any study drug. Participants without documentation of PD or death were censored at the date of last response assessment that was SD or better prior to the date of the alternative therapy.|||months||95% Confidence Interval|Median
2611362|NCT02044510|Primary|Bladder Capacity|Urodynamic bladder capacity|10 weeks||||mL||95% Confidence Interval|Least Squares Mean
2611475|NCT02043379|Secondary|Interleukin-1b Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|pre-operative through 48 hours post-operative||||pg/mL||Inter-Quartile Range|Median
2611112|NCT02046070|Secondary|Time to Response (TTR) in RRMM Participants|TTR is defined as the time interval from the date of the first dose of study treatment to the date of the first documented confirmed response of PR or better up to the alternative therapy in a participant who responded.|Up to 45 months|Participants from the Response Evaluable Population, defined as participants who received at least 2 of the 3 ixazomib doses during Cycle 1, had measurable disease at Baseline, and at least 1 postbaseline response assessment, who responded.|||months||95% Confidence Interval|Median
2611113|NCT02046070|Secondary|Percentage of Participants With (CR + VGPR), CR, VGPR, PR, SD and PD in RRMM Participants|Percentage of participants with CR + VGPR + PR (ORR), CR, VGPR, PR, SD, PD according to IMWG criteria. CR=negative immunofixation of serum and urine; disappearance of soft tissue plasmacytomas;<5% PC in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component <100 mg/24 hour. PR=50% reduction of serum M-protein and reduction in 24 hour urine M-protein by 90% or <200 mg/24 hour or decrease 50% difference between involved FLC levels or 50% reduction in bone marrow plasma cells if baseline percentage was 30%; and if present at Baseline, 50% reduction in the size of soft tissue plasmacytomas. SD=not meeting criteria for VGPR, PR or PD. PD=25% increase in lowest value any of the following: serum M-component, urine M-component, difference between involved and uninvolved FLC levels, bone marrow PC percentage; new or increase in size of existing bone lesions or soft tissue plasmacytomas.|Day 1 of each 28-day Cycle (Up to 45 months)|Response Evaluable Population was defined as participants who received at least 2 of the 3 ixazomib doses during Cycle 1, had measurable disease at Baseline, and at least 1 postbaseline response assessment.|||percentage of participants||95% Confidence Interval|Number
2611114|NCT02046070|Secondary|AUCtau: Area Under the Concentration-time Curve During a Dosing Interval for Ixazomib in RRMM Participants||Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose|PK-Evaluable Population was defined as participants in the safety lead-in cohort who have sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.|||hr*ng/mL||Standard Deviation|Mean
2611115|NCT02046070|Secondary|Tmax: Time to First Occurrence of Cmax for Ixazomib in RRMM Participants||Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168) hours postdose|PK-Evaluable Population was defined as participants in the safety lead-in cohort who have sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.|||hr||Full Range|Median
2611116|NCT02046070|Secondary|Cmax: Maximum Observed Plasma Concentration for Ixazomib in RRMM Participants||Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose|PK-Evaluable Population was defined as participants in the safety lead-in cohort who have sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.|||ng/mL||Standard Deviation|Mean
2611117|NCT02046070|Secondary|Number of Participants With AEs, Grade 3 or Higher AEs, AEs Resulting in Treatment Discontinuation, AEs Resulting in Dose Reduction, SAEs in RRMM Participants|"An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment.~A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator."|First dose of study drug through 30 days after last dose of drug (Up to 45 months)|Safety population was defined as all participants who received at least 1 dose of any study drug.|||Participants|||Count of Participants
2611118|NCT02046070|Secondary|AUCtau: Area Under the Concentration-time Curve During a Dosing Interval for Ixazomib in NDMM Participants||Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose|PK-Evaluable Population was defined as participants in the safety lead-in cohort who have sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.|||hr*ng/mL||Standard Deviation|Mean
2611119|NCT02046070|Secondary|Tmax: Time to First Occurrence of Cmax for Ixazomib in NDMM Participants||Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose|PK-Evaluable Population was defined as participants in the safety lead-in cohort who have sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.|||hour (hr)||Full Range|Median
2611120|NCT02046070|Secondary|Cmax: Maximum Observed Plasma Concentration for Ixazomib in NDMM Participants||Cycle 1 Days 1 and 15 predose and at multiple timepoints (up to 168 hours) postdose|PK-Evaluable Population was defined as participants in the safety lead-in cohort who have sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters. Number analyzed is the number of participants with data available for analysis at the given time-point.|||nanogram/mL (ng/mL)||Standard Deviation|Mean
2611121|NCT02046070|Secondary|Percentage of Participants With CR + VGR + PR (ORR), CR, VGPR, and PR in NDMM Participants Remaining on Treatment After 13 Cycles|Percentage of participants with Overall Response (CR + VGPR + PR), CR, VGPR and PR according to IMWG criteria. CR=negative immunofixation of serum and urine; disappearance of soft tissue plasmacytomas;<5% PC in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component <100 mg/24 hour. PR=50% reduction of serum M-protein and reduction in 24 hour urine M-protein by 90% or <200 mg/24 hour or decrease 50% difference between involved FLC levels or 50% reduction in bone marrow plasma cells if baseline percentage was 30%; and if present at Baseline, 50% reduction in the size of soft tissue plasmacytomas.|Day 1 of each 28-day Cycle (Up to 45 months)|Participants from the Response Evaluable Population, participants who received at least 2 of the 3 ixazomib doses during Cycle 1, had measurable disease at Baseline and at least 1 postbaseline response assessment, with both an Induction and Maintenance response.|||percentage of participants|||Number
2611476|NCT02043379|Secondary|Interleukin-12p70 Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|pre-operative through 48 hours post-operative||||pg/mL||Inter-Quartile Range|Median
2611122|NCT02046070|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) During the Induction Phase in NDMM Participants|EORTC QLQ-C30 is a patient completed 30 item questionnaire that consists of 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The patient evaluates their health status over the previous week. There are 28 questions answered on a 4-point scale where1=Not at all (best) to 4=Very Much (worst) and 2 questions answered on a 7-point scale where 1=Very poor (worst) to 7= Excellent (best). All of the scales and single-item measures are transformed to a score:0 to 100. For functioning scales and global QOL higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement).|Baseline (BL) (Day 1 of Cycle 1), Day 1 of Cycle 13 (Up to 1 year)|Participants from the Safety Population, defined as all participants who received at least 1 dose of any study drug, with data available for analysis.|||score on a scale||Standard Deviation|Mean
2611123|NCT02046070|Secondary|Number of Participants With AEs, SAEs, AEs Resulting in Discontinuation and AEs Resulting in Dose Reduction in NDMM Participants Remaining on Treatment After 13 Cycles|"An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug.~A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator."|First dose of study drug through 30 days after the last dose of drug (Up to 45 months)|Safety Population was defined as all participants who receive at least 1 dose of any study drug. Number of participants analyzed is the number of participants who remained on treatment after 13 cycles.|||Participants|||Count of Participants
2611124|NCT02046070|Secondary|Progression Free Survival (PFS) in NDMM Participants|PFS is defined as the time from the date of first dose of study treatment to the date of the first documented disease progression or death.|Up to 45 months|Safety Population was defined as all participants who received at least 1 dose of any study drug. Participants without documentation of PD or death were censored at the date of last response assessment that is SD or better prior to the date of the alternative therapy.|||months||95% Confidence Interval|Median
2611125|NCT02046070|Secondary|Time to Progression (TTP) in NDMM Participants|TTP is defined as the time from the date of first dose of study treatment to the date of first documentation of disease progression.|Up to 45 months|Safety Population was defined as all participants who received at least 1 dose of any study drug. Participants without documentation of PD were censored at the date of last response assessment that is SD or better prior to the date of the alternative therapy.|||months||95% Confidence Interval|Median
2611126|NCT02046070|Secondary|Duration of Response (DOR) in NDMM Participants|DOR is defined as the time from the date of first documentation of a confirmed PR or better to the date of first documented PD up to the initiation of alternative therapy.|Up to 45 Months|Participants from the Response Evaluable Population, participants who received at least 2 of the 3 ixazomib doses during Cycle 1, had measurable disease at Baseline and at least 1 postbaseline response assessment, who responded. Responders without PD were censored at the date of SD or better prior to the date of alternative therapy.|||months||95% Confidence Interval|Median
2611127|NCT02046070|Secondary|Time to Response (TTR) in NDMM Participants During the Induction Phase|TTR is defined as the time interval from the date of the first dose of study treatment to the date of the first documented confirmed response of PR or better up to the initiation of alternative therapy in a participant who responded.|Up to 1 year|Participants from the Response Evaluable Population, defined as participants who received at least 2 of the 3 ixazomib doses during Cycle 1, had measurable disease at Baseline, and at least 1 postbaseline response assessment, who responded.|||months||95% Confidence Interval|Median
2611128|NCT02046070|Secondary|Percentage of Participants With CR + VGPR + PR (ORR), CR + VGPR, CR, VGPR, PR, SD and PD Throughout the Entire Treatment Period in NDMM Participants|Percentage of participants with CR + VGPR + PR (ORR), CR, VGPR, PR, SD, PD according to IMWG criteria. CR=negative immunofixation of serum and urine; disappearance of soft tissue plasmacytomas;<5% PC in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component <100 mg/24 hour. PR=50% reduction of serum M-protein and reduction in 24 hour urine M-protein by 90% or <200 mg/24 hour or decrease 50% difference between involved FLC levels or 50% reduction in bone marrow plasma cells if baseline percentage was 30%; and if present at Baseline, 50% reduction in the size of soft tissue plasmacytomas. SD=not meeting criteria for VGPR, PR or PD. PD=25% increase in lowest value any of the following: serum M-component, urine M-component, difference between involved and uninvolved FLC levels, bone marrow PC percentage; new or increase in size of existing bone lesions or soft tissue plasmacytomas.|Day 1 of each 28-day Cycle (Up to 45 months)|Response Evaluable Population was defined as participants who received at least 2 of the 3 ixazomib doses during Cycle 1, had measurable disease at Baseline, and at least 1 postbaseline response assessment.|||percentage of participants||95% Confidence Interval|Number
2611137|NCT02045979|Secondary|AUC (0-648) of BI 695501, US-licensed Humira® or EU-approved Humira®|"Area under the concentration time curve (AUC) from time zero to 648 hours post dose (AUC 0-648) of BI 695501, US-licensed Humira® or EU-approved Humira®.~PK is the abbreviation for Pharmacokinetic(s)."|at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648 hours post dosing|The PK analysis set.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2611138|NCT02045979|Secondary|AUC (0-480) of BI 695501, US-licensed Humira® or EU-approved Humira®|"Area under the concentration time curve (AUC) from time zero to 480 hours post dose (AUC 0-480) of BI 695501, US-licensed Humira® or EU-approved Humira®.~PK is the abbreviation for Pharmacokinetic(s)."|at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480 hours post dosing|The PK analysis set.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2611129|NCT02046070|Secondary|Percentage of Participants With CR + VGPR + PR (ORR), CR, VGPR, PR and Stable Disease (SD), Progressive Disease (PD) During the Induction Phase|Percentage of participants with CR + VGPR + PR (ORR), CR, VGPR, PR, SD, PD according to IMWG criteria. CR=negative immunofixation of serum and urine; disappearance of soft tissue plasmacytomas;<5% PC in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component <100 mg/24 hour. PR=50% reduction of serum M-protein and reduction in 24 hour urine M-protein by 90% or <200 mg/24 hour or decrease 50% difference between involved FLC levels or 50% reduction in bone marrow plasma cells if baseline percentage was 30%; and if present at Baseline, 50% reduction in the size of soft tissue plasmacytomas. SD=not meeting criteria for VGPR, PR or PD. PD=25% increase in lowest value any of the following: serum M-component, urine M-component, difference between involved and uninvolved FLC levels, bone marrow PC percentage; new or increase in size of existing bone lesions or soft tissue plasmacytomas.|Day 1 of Cycles 1-13, 28-day cycles (Up to 1 year)|Response Evaluable Population was defined as participants who received at least 2 of the 3 ixazomib doses during Cycle 1, had measurable disease at Baseline, and at least 1 postbaseline response assessment.|||percentage of participants||95% Confidence Interval|Number
2611130|NCT02046070|Secondary|Number of Participants With Adverse Events (AEs), Grade 3 or Higher AEs, AEs Resulting in Treatment Discontinuation, AEs Resulting in Dose Reduction and Serious Adverse Events (SAEs) in NDMM Participants|"An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug.~A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. Relationship of each AE to study drug was determined by the Investigator."|First dose of study drug through 30 days after last dose of drug (Up to 45 months)|Safety Population was defined as all participants who receive at least 1 dose of any study drug.|||Participants|||Count of Participants
2611131|NCT02046070|Primary|Overall Response Rate (ORR) in Relapsed and/or Refractory Multiple Myeloma (RRMM) Participants|ORR is the percentage of participants with CR, VGPR or PR according to IMWG criteria. CR=negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells (PC) in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component <100 mg/24 hour. PR=50% reduction of serum M-protein and reduction in 24 hour urine M-protein by 90% or <200 mg/24 hour or decrease 50% difference between involved free light chain (FLC) levels or 50% reduction in bone marrow plasma cells if baseline percentage was 30%; and if present at Baseline, 50% reduction in the size of soft tissue plasmacytomas.|Day 1 of each 28 day cycle (Up to 45 months)|Response Evaluable Population was defined as participants who received at least 2 of the 3 ixazomib doses during Cycle 1, had measurable disease at Baseline, and at least 1 postbaseline response assessment.|||percentage of participants||95% Confidence Interval|Mean
2611132|NCT02046070|Primary|Combined Response Rate During the Induction Phase in Newly Diagnosed Multiple Myeloma (NDMM) Participants|Combined Response Rate is the percentage of participants with Complete Response (CR), including stringent Complete Response (sCR), and Very Good Partial Response (VGPR) according to the International Myeloma Working Group (IMWG) criteria during the Induction Phase (Cycles 1-13, 28-day cycles). CR=negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow. VGPR=serum and urine M-component detectable by immunofixation but not on electrophoresis or 90% reduction in serum M-component plus urine M-component <100 mg/24 hour.|Day 1 of Cycles 1-13, 28-day cycles (Up to 1 year)|Response Evaluable Population was defined as participants who received at least 2 of the 3 ixazomib doses during Cycle 1, had measurable disease at Baseline, and at least 1 postbaseline response assessment.|||percentage of participants||95% Confidence Interval|Number
2611133|NCT02046005|Primary|Contemplation Ladder|Measures willingness to change any of 4 RA-related behaviors compared to baseline using generalized estimating equations to compare the PRE-RA groups to the comparison arm.|Immediately, 6 weeks, and 6 months after intervention||||Participants|||Count of Participants
2611134|NCT02045979|Secondary|Number (Proportion) of Subjects With Drug Related Adverse Events|"All events with an onset after the first administration of the trial medication up to a period of 70 days after the last administration of the trial medication (i.e., end of the REP) was assigned to the treatment phase for evaluation and was defined as a treatment-emergent AE (TEAE). A treatment-related AE was defined as any TEAE assessed by the investigator as related to the trial medication.~All safety data were displayed and analyzed using descriptive statistical methods. No formal inferential analyses were planned for safety comparisons. Tabulations of frequencies and proportions, as appropriate were used for the evaluation of categorical (qualitative) data, and tabulations of descriptive statistics were used to analyze continuous (quantitative) data."|Day 1 through Day 71|The safety analysis set consisted of all subjects who received the single dose of trial medication (BI 695501, US-licensed Humira® or EU-approved Humira®).|||participants|||Number
2611135|NCT02045979|Secondary|AUC 0-∞,Obs of BI 695501, US-licensed Humira® or EU-approved Humira®|"Area under the concentration time curve (AUC) from time zero to infinity (AUC 0-∞) based on the last observed concentration at time of last measureable concentration (tz) of BI 695501, US-licensed Humira® or EU-approved Humira®.~PK is the abbreviation of Pharmacokinetic(s)."|at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.|The PK analysis set.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2611136|NCT02045979|Secondary|AUC (0-1032) of BI 695501, US-licensed Humira® or EU-approved Humira®|Area under the concentration time curve (AUC) from time zero to 1032 hours post dose (AUC 0-1032) of BI 695501, US-licensed Humira® or EU-approved Humira® PK is the abbreviation for Pharmacokinetic(s).|at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032 hours post dosing|The PK analysis set.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2611477|NCT02043379|Secondary|Interleukin-10 Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|pre-operative through 48 hours post-operative||||pg/mL||Inter-Quartile Range|Median
2611139|NCT02045979|Secondary|AUC (0-312) of BI 695501, US-licensed Humira® or EU-approved Humira®|"Area under the concentration time curve (AUC) from time zero to 312 hours post dose (AUC 0-312) of BI 695501, US-licensed Humira® or EU-approved Humira®.~PK is the abbreviation for Pharmacokinetic(s)."|at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312 hours post dosing|The PK analysis set.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2611140|NCT02045979|Secondary|AUC (0-168) of BI 695501, US-licensed Humira® or EU-approved Humira®|"Area under the concentration time curve (AUC) from time zero to 168 hours post dose (AUC 0-168) of BI 695501, US-licensed Humira® or EU-approved Humira®.~PK is the abbreviation for Pharmacokinetic(s)."|at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168 hours post dosing|The PK analysis set.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2611141|NCT02045979|Primary|Maximum Concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira®|Maximum concentration (Cmax) of BI 695501, US-licensed Humira® or EU-approved Humira®.|at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.|The PK analysis set.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2611142|NCT02045979|Primary|Area Under the Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira®|Area under the concentration time curve from time zero to last measurable concentration (AUC0-tz) of BI 695501, US-licensed Humira® or EU-approved Humira®.|at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.|The PK analysis set.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2611143|NCT02045979|Primary|Area Under the Concentration Time Curve (AUC) From Time Zero to Infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira®|"Area under the concentration time curve (AUC) from time zero to infinity (AUC 0-∞) of BI 695501, US-licensed Humira® or EU-approved Humira®.~Abbreviation used: Pharmacokinetics (PK)."|at -1 hour (h) (pre dosing) and 1h, 4, 8, 12, 24, 48, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 1032, 1320 h post dosing and on day 71 post dosing.|PK analysis set consisted of all randomized subjects who received the single dose of trial medication (BI 695501, US-licensed - or EU-approved Humira®), had at least one evaluable primary PK endpoint and were without important protocol deviations or violations thought to significantly affect the PK of BI 695501, US-licensed - or EU-approved Humira®|||microgram (µg)*hour (h)/millilitre (mL)||Geometric Coefficient of Variation|Geometric Mean
2611144|NCT02045875|Secondary|Overall Adherence to Dulera 100/5 and 200/5|"Subjects in the monitoring group will have adherence greater than or equal to the 60% benchmark~Overall interval value was the mean of daily percent"|3 months|Data was only collected in the interventional group.|||percent of prescribed doses per day||Standard Deviation|Mean
2611145|NCT02045875|Secondary|Adherence to Dulera 100/5 and 200/5|"Subjects in the monitoring group will have adherence greater than or equal to the 60% benchmark~Adherence was calculated by taking the number of doses actually taken divided by the number of doses prescribed and multiplying by 100."|week 2. months 1, 2, and 3|Data was only collected in the interventional group.|||percent of prescribed doses||Standard Deviation|Mean
2611146|NCT02045875|Primary|Asthma Control|Asthma Control Questionnaire measured at each office visit. ACQ integrates values by 6 clinical questions related to symptoms and the value related to FEV1% predicted with a total score ranging from 0-6 and higher values indicating poorer asthma control.|Baseline, one, two and three months|All patients who completed ACQ at 4 clinical visits were included in the analysis|||units on a scale||Standard Deviation|Mean
2611147|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume|PVR volume was assessed by ultrasonography or a bladder scanner.|Baseline and Months 1, 3, 6, 9, 12|SAF population with data available at each time point. LOCF was used for EoT.|||mL||Standard Deviation|Mean
2611148|NCT02045862|Secondary|Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT|The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The HRQoL portion of the OAB-q consists of 25 HRQoL items comprising 4 HRQoL subscales, each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
2611149|NCT02045862|Secondary|Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT|The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The symptom bother portion of the OAB-q consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
2611363|NCT02044458|Other Pre-specified|Failure Rates of the Placement of a Foley Catheter|To compare the failure rate of the placement of a Foley catheter for the induction of labor in women randomly allocated to rigid stylette or no stylette|Followed throughout patient's hospital stay, approximately 10 days||||failed attempt|||Number
2611150|NCT02045862|Secondary|Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
2611151|NCT02045862|Secondary|Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Months 1, 3, 6, 9, 12 and EoT|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
2611152|NCT02045862|Secondary|Percentage of Participants Who Were Double Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Months 1, 3, 6, 9, 12 and EoT|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
2611153|NCT02045862|Secondary|Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT|The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
2611154|NCT02045862|Secondary|Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT|The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
2611155|NCT02045862|Secondary|Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT|The percentage of participants with micturition frequency normalization was defined as participants who had ≥ 8 micturitions/24 hours at baseline and < 8 micturitions/24 hours postbaseline at months 1, 3, 6, 9, 12 and EoT.|Baseline and Months 1, 3, 6, 9, 12|FAS with data available at each time point. Participants with less < 8 micturitions per 24 hours at baseline were not included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
2611156|NCT02045862|Secondary|Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the 7-day micturition diary is reported.|Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
2611157|NCT02045862|Secondary|Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit.|Baseline and Months 1, 3, 6, 9, 12|FAS with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
2611158|NCT02045862|Secondary|Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT|The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
2611190|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours|A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and prior to each visit.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point.|||micturitions||Standard Error|Least Squares Mean
2611159|NCT02045862|Secondary|Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT|The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
2611160|NCT02045862|Secondary|Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the last 3 days of the 7-day micturition diary is reported.|Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||percentage of participants|||Number
2611161|NCT02045862|Secondary|Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment|The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.|Baseline and Months 6, 12|FAS population with data available at each time point. Only participants with both baseline and post-baseline values during the study are included in the analysis. LOCF was used for EoT.|||percentage of activity Impairment||Standard Deviation|Mean
2611162|NCT02045862|Secondary|Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment|The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes arre expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.|Baseline and Months 6, 12|FAS population with data available at each time point. Only participants with both baseline and post-baseline values and who were employed during the study are included in the analysis. LOCF was used for EoT.|||percentage of overall work impairment||Standard Deviation|Mean
2611163|NCT02045862|Secondary|Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working|The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.|Baseline and Months 6, 12|FAS population with data available at each time point. Only participants with both baseline and post-baseline values and who were employed during the study are included in the analysis. LOCF was used for EoT.|||percentage of impairment while working||Standard Deviation|Mean
2611164|NCT02045862|Secondary|Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed|The WPAI:SHP is a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.|Baseline and Months 6,12|FAS population with data available at each time point. Only participants with both baseline and post-baseline values and who were employed during the study are included in the analysis. LOCF was used for EoT.|||percentage of work time missed||Standard Deviation|Mean
2611165|NCT02045862|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression|The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and had 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and Month 12|FAS population; LOCF was used for EoT.|||Participants|||Count of Participants
2611166|NCT02045862|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort|The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and had 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and Month 12|FAS population; LOCF was used for EoT.|||Participants|||Count of Participants
2611167|NCT02045862|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities|The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and Month 12|FAS population; LOCF was used for EoT.|||Participants|||Count of Participants
2611348|NCT02044796|Primary|Minimal Residual Disease Negative Complete Remission Rate in Patients With Newly Diagnosed Disease (Phase II)|Remission Rate defined as Recist Category of Complete Resposne (CR) Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size(<10 mm short axis).|Up to day 45 after start of second course of induction chemotherapy||||Participants|||Count of Participants
2611168|NCT02045862|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care|The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and Month 12|FAS populaton; LOCF was used for EoT.|||Participants|||Count of Participants
2611169|NCT02045862|Secondary|Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility|The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and 12 Months|FAS population; LOCF was used for EoT.|||Participants|||Count of Participants
2611170|NCT02045862|Secondary|Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT|The PGIC is a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).|Month 12|FAS population with data available. LOCF was used for EoT.|||percentage of participants|||Number
2611171|NCT02045862|Secondary|Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT|The PGIC is a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).|Month 12|FAS population with data available. LOCF was used for EoT.|||percentage of participants|||Number
2611172|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)|The PPBC is a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
2611173|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS|The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
2611174|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social|The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
2611175|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep|The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consisted of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each time was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
2611176|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern|The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
2611177|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping|The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
2611178|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score|The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
2611478|NCT02043379|Secondary|Respiratory Variables|Total time duration of post-operative length of mechanical ventilation until hospital discharge|until extubation, an average of 2 days||||hours||Inter-Quartile Range|Median
2611179|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score|The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
2611180|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit|The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Only participants with ≥ 1 pad used at baseline were included in the analysis. LOCF was used for EoT.|||pads||Standard Error|Least Squares Mean
2611181|NCT02045862|Secondary|Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit|The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.|Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Only participants with ≥ 1 pad used at baseline were included in the analysis. LOCF was used for EoT.|||pads||Standard Error|Mean
2611182|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours|The mean number of pads used per 24 hours was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Only participants with ≥ 1 pads used at baseline were included in the analysis. LOCF was used for EoT.|||pads||Standard Error|Least Squares Mean
2611183|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit|A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis. LOCF was used for EoT.|||nocturia episodes||Standard Error|Least Squares Mean
2611184|NCT02045862|Secondary|Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit|A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit.|Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis. LOCF was used for EoT.|||nocturia episodes||Standard Error|Mean
2611185|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours|"A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The mean number of nocturia episodes was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit."|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis. LOCF was used for EoT.|||nocturia episodes||Standard Error|Least Squares Mean
2611186|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours|Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode recorded by the participant in the micturition diary for 7 days prior to each visit as 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Participants with ≥ 1 urgency episode at baseline were included in the analysis. LOCF was used for EoT.|||urgency episodes||Standard Error|Least Squares Mean
2611187|NCT02045862|Secondary|Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition|The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period prior to each visit.|Baseline and Months 3, 6, 12|FAS population with data available at each time point.|||mL||Standard Error|Least Squares Mean
2611188|NCT02045862|Secondary|Change From Baseline to EoT in Corrected Micturition Frequency|Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline. Corrected micturition frequency was calculated as the baseline mean volume voided per micturition multiplied by the baseline mean number of micturitions per 24 hours divided by the mean volume voided per micturition at EoT.|Baseline and Month 12|FAS population; LOCF was used for EoT.|||micturitions||Standard Error|Least Squares Mean
2611189|NCT02045862|Secondary|Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)|The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with with less than 8 micturitions per day.|Months 1, 3, 6, 9, 12|FAS population with data available at each time point; LOCF was used for EoT.|||days||Standard Error|Mean
2611349|NCT02044796|Primary|Number of Participants With Dose Limiting Toxicities of Mitoxantrone (Phase I, Dose Level 4)|Defined as the highest dose studied in which the incidence of dose-limiting toxicity is < 33%, graded according to NCI Common Terminology Criteria for Adverse Events version 4.0|Up to day 45 after start of induction chemotherapy||||Participants|||Count of Participants
2611191|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit|An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis. LOCF was used for EoT.|||urgency incontinence episodes||Standard Error|Least Squares Mean
2611192|NCT02045862|Secondary|Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit|An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceeded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.|Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis. LOCF was used for EoT.|||urgency incontinence episodes||Standard Error|Mean
2611193|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours|An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis. LOCF was used for EoT.|||urgency incontinence episodes||Standard Error|Least Squares Mean
2611194|NCT02045862|Secondary|Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit|The number of incontinence-free days with < 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day.|Months 1, 3, 6, 9, 12|FAS population with data available at each time point; LOCF was used for EoT.|||days||Standard Error|Mean
2611195|NCT02045862|Secondary|Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit|The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period prior to each visit with no incontinence episodes recorded.|Months 1, 3, 6, 9, 12|FAS population with with data available at each time point; LOCF was used for EoT.|||incontinence-free days||Standard Error|Mean
2611196|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point; LOCF was used for EoT.|||incontinence episodes||Standard Error|Least Squares Mean
2611197|NCT02045862|Secondary|Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.|Months 1, 3, 6, 9, 12|FAS population with data available at each time point; LOCF was used for EoT.|||incontinence episodes||Standard Error|Mean
2611198|NCT02045862|Secondary|Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and prior to each visit.|Baseline and Months 1, 3, 6, 9, 12|FAS population with data available at each time point.|||incontinence episodes||Standard Error|Least Squares Mean
2611199|NCT02045862|Secondary|Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)|The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.|Baseline and Week 52|FAS population with baseline and at least one post-baseline measurement; LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
2611200|NCT02045862|Secondary|Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score|The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.|Baseline and Week 52|FAS population with baseline and at least one post-baseline measurement; LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
2611201|NCT02045862|Secondary|Change From Baseline to EoT in Mean Volume Voided Per Micturition|The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period.|Baseline and Week 52|FAS population with baseline and at least one post-baseline measurement; LOCF was used for EoT.|||mL||Standard Error|Least Squares Mean
2611202|NCT02045862|Primary|Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours|A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and week 52 clinic visits.|Baseline and Week 52|FAS population; LOCF was used for EoT.|||micturitions||Standard Error|Least Squares Mean
2611350|NCT02044510|Secondary|Secondary Urodynamic Characteristics: Volume at First Detrusor Overactivity||10 weeks|||||||
2611351|NCT02044510|Secondary|Secondary Urodynamic Characteristics: Bladder Compliance||10 weeks|||||||
2611352|NCT02044510|Secondary|Secondary Urodynamic Characteristics: Bladder Sensation||10 weeks|||||||
2611203|NCT02045862|Primary|Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and week 52 clinic visits.|Baseline and Week 52|FAS population; Last observation carried forward (LOCF) was used for EoT.|||incontinence episodes||Standard Error|Least Squares Mean
2611204|NCT02045862|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE was defined as an adverse event (AE) observed after taking the first dose of double-blind treatment until 14 days after taking the last dose of double-blind treatment for non-serious AEs and until 30 days after taking the last dose of double-blind treatment for serious adverse events (SAEs). This included abnormal laboratory tests, vital signs or electrocardiogram data that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The severity of each AE was defined according to the following: Mild (No disruption of normal daily activities); Moderate (Affected normal daily activities) and Severe (Inability to perform daily activities).|From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks)|The analysis population was the safety analysis set (SAF), which consisted of all participants who received ≥ 1 dose of double-blind study drug and excluded participants from one site due to protocol noncompliance.|||Participants|||Count of Participants
2611205|NCT02045836|Secondary|Number of Subjects With Potential Immune Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the period starting after 30 days post last vaccination up to study end (Month 3 - Month 14 for the Co-Ad Group &amp; Month 5 - Month 16 for the Control Group)|The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.|||Participants|||Count of Participants
2611206|NCT02045836|Secondary|Number of Subjects With Potential Immune Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From first vaccination up to 30 days post last vaccination (Month 0 - Month 3 for the Co-Ad Group &amp; Month 0 - Month 5 for the Control Group)|The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.|||Participants|||Count of Participants
2611207|NCT02045836|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From the first dose up to 30 days post last vaccination period|The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.|||Participants|||Count of Participants
2611208|NCT02045836|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|From the first dose up to 30 days post last vaccination period||||Participants|||Count of Participants
2611209|NCT02045836|Secondary|Number of Days With Any Solicited Local and General Symptoms|The Co-Ad Group received only 2 vaccine doses, hence the number of participants for the Dose 3 categories in this group is 0.|Within 7 days (Days 0 - 6) after each vaccination|The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.|||days||Inter-Quartile Range|Median
2611210|NCT02045836|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|This analysis was performed on the Total Vaccinated cohort, including subjects with at least one vaccine dose administered, only on those subjects with completed symptom sheets.|||Participants|||Count of Participants
2611211|NCT02045836|Secondary|Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within 7 days (Days 0 - 6) after vaccination|The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.|||Participants|||Count of Participants
2611212|NCT02045836|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses.|Within 7 days (Days 0 - 6) after each vaccination|The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.|||Participants|||Count of Participants
2611353|NCT02044510|Secondary|Secondary Urodynamic Characteristics: Volume at Maximum Detrusor Pressure||10 weeks|||||||
2611354|NCT02044510|Secondary|Secondary Urodynamic Characteristics: Maximum Detrusor Pressure||10 weeks|||||||
2611355|NCT02044510|Secondary|Adverse Events|Adverse events will be monitored passively. They will be actively monitored for hypertension, tachycardia, and urinary retention.|10 weeks|||||||
2611213|NCT02045836|Primary|Adjusted GMCs Between Groups|The Adjusted ratios of GMCs between groups (Control group and Co-Ad group) was presented for anti-gE antibody ELISA concentrations|At 1 month after last vaccine dose|This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2611214|NCT02045836|Primary|Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups|The Adjusted ratios of GMTs between groups (Control group and Co-Ad group) were presented for each individual pneumococcal conjugate serotype Opsonophagocytic Activity (OPA).|At 1 month after vaccination|This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2611215|NCT02045836|Primary|Anti-pneumococcal Antibody Titers|Anti-pneumococcal antibody titers were presented as geometric mean titers (GMTs) for the 12 following serotypes as determined by Opsonophagocytic Assay (OPA): 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.|At one month post-dose (Month 1)|This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2611216|NCT02045836|Primary|Anti-glicoprotein E (gE) Antibody Concentrations|Antibody concentrations were determined by ELISA, presented as geometric mean concentrations and expressed as milli international units per milliliter (mIU/mL).|At one month post-dose 2 (Month 3 for the Co-Ad Group and Month 5 for the Control Group)|This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2611217|NCT02045836|Primary|Number of Subjects With a Vaccine Response for Anti-gE Antibodies|"Vaccine response rate for anti-gE antibody concentrations, as determined by enzyme-linked immunosorbent assay (ELISA), in subjects from the Co-Ad group. Vaccine response defined as :~For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL) For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration"|At Month 3|This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2611218|NCT02045797|Secondary|Number of Participants With Abnormal Urinalysis Dipstick Results|Samples for urinalysis assessment was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28 for Glucose, Ketones, Occult Blood, Protein and pH. Participants with abnormal urinalysis result was reported.|Up to day 28|Safety Population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2611219|NCT02045797|Secondary|Change From Baseline in Hematology Parameters: Hematocrit|Blood samples for assessment of hematology parameter of hematocrit was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Ratio||Standard Deviation|Mean
2611220|NCT02045797|Secondary|Change From Baseline in Hematology Parameters: Erythrocytes|Blood samples for assessment of hematology parameter of erythrocyte was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Trillion cells per liter||Standard Deviation|Mean
2611221|NCT02045797|Secondary|Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Volume (EMCV)|Blood samples for assessment of hematology parameter of EMCV was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Femtoliter||Standard Deviation|Mean
2611222|NCT02045797|Secondary|Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin (EMCH)|Blood samples for assessment of hematology parameter of EMCH was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Picograms||Standard Deviation|Mean
2611233|NCT02045797|Secondary|Change From Baseline in Respiratory Rate|Respiratory rate was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Breaths per minute||Standard Deviation|Mean
2611223|NCT02045797|Secondary|Change From Baseline in Hematology Parameters: Erythrocyte Mean Corpuscular Hemoglobin Concentration (EMCHC) and Hemoglobin|Blood samples for assessment of hematology parameters of EMCHC and hemoglobin was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Gram per liter||Standard Deviation|Mean
2611224|NCT02045797|Secondary|Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets|Blood samples for assessment of hematology parameters of basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Giga cells per liter||Standard Deviation|Mean
2611225|NCT02045797|Secondary|Estradiol Values at Baseline|Blood samples for assessment of clinical chemistry parameter of estradiol was collected at Baseline (Day 1). No post-baseline values were reported.|Baseline (Day 1)|Safety Population. Only those participants available at the indicated time points were analyzed.|||Picomole per liter||Standard Deviation|Mean
2611226|NCT02045797|Secondary|Change From Baseline in Clinical Chemistry Parameters: Creatinine Clearance, Estimated|Blood samples for assessment of clinical chemistry parameter of estimated creatinine clearance was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety Population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Milliliter per minute||Standard Deviation|Mean
2611227|NCT02045797|Secondary|Change From Baseline in Clinical Chemistry Parameters: Calcium, Carbon Dioxide, Chloride, Glucose, Magnesium, Potassium, Sodium and Urea|Blood samples for assessment of clinical chemistry parameters of calcium, carbon dioxide, chloride, glucose, magnesium, potassium, sodium and urea was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Millimole per liter||Standard Deviation|Mean
2611228|NCT02045797|Secondary|Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin and Urate|Blood samples for assessment of clinical chemistry parameters of bilirubin, creatinine, direct bilirubin and urate was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Micromoles per liter||Standard Deviation|Mean
2611229|NCT02045797|Secondary|Change From Baseline in Clinical Chemistry Parameters: Albumin and Protein|Blood samples for assessment of clinical chemistry parameters of albumin and total protein was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Gram per liter||Standard Deviation|Mean
2611230|NCT02045797|Secondary|Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Follicle Stimulating Hormone (FSH) and Gamma Glutamyl Transferase (GGT)|Blood samples for assessment of clinical chemistry parameters of ALT, ALP, AST, FSH and GGT was collected at Baseline (Day 1), Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||International units per liter||Standard Deviation|Mean
2611231|NCT02045797|Secondary|Number of Participants With Maximum Post-Baseline Electrocardiogram (ECG) Readings|The 12-lead ECGs was obtained at Day 1, Day 2, Day 7 to 10, Day 12 to 21 and Day 21 to Day 28 for corrected QT, using Fridericia formula (QTcF), corrected QT using Bazett's formula (QTcB) and QRS intervals. The number of participants with maximum post-baseline ECG value exceeding the following limits have been reported: QTcB/QTcF interval > 450 and ≤ 480 millisecond (msec), QTcB/QTcF interval > 480 and ≤ 500 msec, QTcB/QTcF interval > 500 msec, QRS interval < 70 msec and QRS interval > 120 msec.|Up to Day 28|Safety Population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2611232|NCT02045797|Secondary|Change From Baseline in Vital Sign: Body Temperature|Body temperature was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Celcius||Standard Deviation|Mean
2611356|NCT02044510|Secondary|Patient Perception of Bladder Condition|The patient perception of bladder condition is a commonly used measure in the assessment of oral medications for the treatment of overactive bladder symptoms|10 weeks|||||||
2611234|NCT02045797|Secondary|Change From Baseline in Pulse Rate|Pulse rate was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Beats per minute||Standard Deviation|Mean
2611235|NCT02045797|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP was measured with the participant in a supine or semi-supine position, having rested in that position for at least 10 minutes. Baseline was defined at Day 1. Change from Baseline was calculated by subtracting the post-Baseline value from Baseline value.|Baseline (Day 1) up to Day 28|Safety population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Millimeters of mercury||Standard Deviation|Mean
2611236|NCT02045797|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, medically significant or all events of possible drug-induced liver injury with hyperbilirubinemia.|Up to Day 28|Safety population comprised the same set of participants from MITT population and received at least one dose of study medication.|||Participants|||Count of Participants
2611237|NCT02045797|Secondary|Number of Participants Demonstrating a Decrease in GSK2140944 Susceptibility When Comparing Isolates Recovered From Baseline With Those From Any Time Post-Baseline Skin Specimens|Reduction in susceptibility was defined as a >=4-fold increase in minimum inhibitory concentration (MIC) or >=6 millimeter decrease in zone size between an isolate obtained at Baseline and the same pathogen at subsequent visits.|Up to Day 28|Modified MITT Population.|||Participants|||Count of Participants
2611238|NCT02045797|Secondary|PK Parameters (From GSK2140944 Plasma Concentration-time Data): AUC (0-t) and AUC(0-tau) on Oral Dose Therapy|Samples for assessment of PK parameters AUClast and AUC0-tau was done at predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The AUC 0-t and AUC0-tau was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Data for participants while on oral dose therapy has been presented.|Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose)|PK Parameter Population. Only those participants available at the indicated time points were analyzed.|||Hour nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2611239|NCT02045797|Secondary|PK Parameters (From GSK2140944 Plasma Concentration-time Data): Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Time of the Last Quantifiable Concentration [AUC (0-t)] and AUC Over the Dosing Interval [AUC(0-tau)] on IV Therapy|Samples for assessment of PK parameters AUClast and AUC0-tau was done at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The AUC 0-t and AUC0-tau was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Data for participants while on IV therapy has been presented.|Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3|PK Parameter Population. Only those participants available at the indicated time points were analyzed.|||Hour nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2611240|NCT02045797|Secondary|PK Parameters (From GSK2140944 Plasma Concentration-time Data): Tmax on Oral Dose Therapy|Samples for assessment of PK parameter tmax was done at Predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The time at which Cmax was observed was determined directly from the raw concentration-time data. Data for participants while on oral dose therapy has been presented.|Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose)|PK Parameter Population. Only those participants available at the indicated time points were analyzed.|||Hours||Full Range|Median
2611241|NCT02045797|Secondary|PK Parameters (From GSK2140944 Plasma Concentration-time Data): Time to Cmax (Tmax) on IV Therapy|Samples for assessment of PK parameter tmax was done at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The time at which Cmax was observed was determined directly from the raw concentration-time data. Data for participants while on IV therapy has been presented.|Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3|PK Parameter Population. Only those participants available at the indicated time points were analyzed.|||Hours||Full Range|Median
2611242|NCT02045797|Secondary|PK Parameters (From GSK2140944 Plasma Concentration-time Data): Cmax on Oral Dose Therapy|Samples for assessment of PK parameter Cmax was done at Predose, 1, 2, 3 hours after first orally administered drug and one predose time point anytime from Day 7 to 10. The first occurrence of the Cmax was determined directly from the raw concentration-time data. Data for participants while on oral dose therapy has been presented.|Predose, 1, 2, 3 hours after first orally administered drug and Day 7 to 10 (predose)|PK Parameter Population. Only those participants available at the indicated time points were analyzed.|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2611243|NCT02045797|Secondary|Pharmacokinetic (PK) Parameters (From GSK2140944 Plasma Concentration-time Data): Maximum Observed Concentration (Cmax) on IV Therapy|Samples for assessment of PK parameter Cmax was done on at predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3. The first occurrence of the Cmax was determined directly from the raw concentration-time data. Data for participants while on IV therapy has been presented.|Predose, 1, 2, 2.5, 3, 6, 12 hours post dose on Day 1 to 3|PK Parameter Population consisted of all participants in the PK concentration population for whom valid and evaluable PK parameters were derived. Only those participants available at the indicated time points were analyzed.|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2611479|NCT02043379|Secondary|Respiratory Variables|Time until first extubation in hours|until extubation, an average of 2 days||||hours||Inter-Quartile Range|Median
2611244|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample|Microbiological outcome was determined by comparing Baseline blood culture, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA, MRSA and all Gram-positive aerobic pathogens in lesion sample has been presented.|Day 21 to Day 28|Modified Microbiological ITT population.|||Number of pathogens|||Number
2611245|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for All Gram-positive Aerobic Pathogens in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for all Gram-positive aerobic pathogens in lesion sample has been presented.|Day 21 to Day 28|Modified Microbiological ITT population.|||Number of pathogens|||Number
2611246|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for other Gram-positive aerobic pathogens in lesion sample has been presented.|Day 21 to Day 28|Modified Microbiological ITT population.|||Number of pathogens|||Number
2611247|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MSSA in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MSSA pathogen in lesion sample has been presented.|Day 21 to Day 28|Modified Microbiological ITT population.|||Number of pathogens|||Number
2611248|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for MRSA in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MRSA pathogen in lesion sample has been presented.|Day 21 to Day 28|Modified Microbiological ITT population.|||Number of pathogens|||Number
2611249|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Follow up Visit for SA Pathogen in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at final follow up visit. Corresponding response (success or failure) was then assigned. Microbiological eradication was culture documented elimination of Baseline pathogens from a bacteriology specimen taken at final follow up visit. Presumed microbiological eradication was when there was a clinical success and no bacteriological specimen was obtained at final follow up visit. Culture documented presence of Baseline pathogens in a bacteriology specimen taken at final follow up visit was microbiological recurrence. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at final follow up visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA pathogen in lesion sample has been presented.|Day 21 to Day 28|Modified Microbiological ITT.|||Number of pathogens|||Number
2611283|NCT02045264|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Icatibant and Metabolites|AUC0-t is the area under the plasma concentration versus time curve extrapolated from time 0 to to the last quantifiable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*hr/mL||Standard Deviation|Mean
2611250|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine.|Day 12 to Day 18|Modified Microbiological ITT population.|||Number of pathogens|||Number
2611251|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine.|Day 12 to Day 18|Modified Microbiological ITT population.|||Number of pathogens|||Number
2611252|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine.|Day 12 to Day 18|Modified Microbiological ITT population.|||Number of pathogens|||Number
2611253|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MSSA in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MSSA in lesion sample has been presented.|Day 12 to Day 18|Modified Microbiological ITT population.|||Number of pathogens|||Number
2611254|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for MRSA in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for MRSA in lesion sample has been presented.|Day 12 to Day 18|Modified Microbiological ITT population.|||Number of pathogens|||Number
2611255|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Post Therapy Visit for SA Pathogen in Lesion Sample|Microbiological outcome was determined by comparing Baseline lesion sample, to culture results at post therapy visit. Corresponding response (success or failure) was then assigned. Microbiological eradication or persistence was culture documented elimination or presence of Baseline pathogens from a specimen taken at post therapy visit respectively. Presence of pathogens which was presumed to be eradicated at early efficacy visit was microbiological recurrence. Presumed microbiological eradication or persistence was when there was a clinical success or failure and no bacteriological specimen was obtained at post therapy respectively. Presumed microbiological recurrence was when there was a clinical failure and no bacteriological specimen was obtained at post therapy visit for pathogens presumed eradicated at early efficacy visit. When the determination of Baseline pathogen response could not be made, the outcome was unable to determine. Data for SA in lesion sample has been presented.|Day 12 to Day 18|Modified Microbiological ITT population.|||Number of pathogens|||Number
2611284|NCT02045264|Secondary|Safety Evaluation Measured by Percentage of Subjects With Not Clinically Significant Abnormalities in ECG Results||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.|||percentage of participants|||Number
2611256|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for SA, MRSA and All Gram-positive Aerobic Pathogens in Blood Sample|The microbiological outcome was determined by comparing Baseline bacteriology blood culture, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for SA, MRSA and all Gram-positive aerobic pathogens in blood sample has been presented.|Up to Day 3|Modified Microbiological ITT population.|||Number of pathogens|||Number
2611257|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for All Gram-positive Aerobic Pathogens in Lesion Sample|The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for all Gram-positive aerobic pathogens in lesion sample has been presented.|Up to Day 3|Modified Microbiological ITT population.|||Number of pathogens|||Number
2611258|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Other Gram-positive Aerobic Pathogens in Lesion Sample|The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for other Gram-positive aerobic pathogens in lesion sample has been presented.|Up to Day 3|Modified Microbiological ITT population.|||Number of pathogens|||Number
2611259|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-susceptible Staphylococcus Aureus (MSSA) in Lesion Sample|The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for MSSA in lesion sample has been presented.|Up to Day 3|Modified Microbiological ITT population.|||Number of pathogens|||Number
2611260|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Methicillin-resistant Staphylococcus Aureus (MRSA) in Lesion Sample|The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for MRSA in lesion sample has been presented.|Day 3|Modified Microbiological ITT population.|||Number of pathogens|||Number
2611261|NCT02045797|Secondary|Number of Pathogens With Microbiological Response and Outcome at Early Efficacy Visit for Staphylococcus Aureus (SA) Pathogen in Lesion Sample|The microbiological outcome was determined by comparing Baseline bacteriology lesion sample, to the culture results at early efficacy visit. The corresponding microbiological response (success or failure) by participant was then assigned. Microbiological eradication or persistence was defined as culture documented elimination or presence of Baseline pathogens from a bacteriology specimen taken at early efficacy visit respectively. Participant was considered to have outcome of presumed microbiological eradication or persistence when the participant was a clinical success or clinical failure and no bacteriological specimen was obtained at early efficacy visit respectively. When the determination of Baseline pathogen microbiological response could not be made, the outcome was considered as unable to determine. The data for SA in lesion sample has been presented.|Up to Day 3|Modified Microbiological ITT consisted of all randomized participants who received at least one dose of study medication and had a Gram-positive pathogens identified from their Baseline bacteriology lesion sample.|||Number of pathogens|||Number
2611285|NCT02045264|Secondary|The Percentage of Subjects With Any Injection Site Reactions.||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.|||percentage of participants|||Number
2611286|NCT02045264|Secondary|The Total Number of Treatment-Emergent Adverse Events|Treatment-emergent adverse events (TEAEs) were those that started after the single dose of icatibant.|TEAEs were collected after the single dose of icatibant until follow up, 5-7 days after icatibant administration|The Safety Set consisted of all subjects who had taken the single dose of icatibant.|||Treatment Emergent Adverse Events|||Number
2611262|NCT02045797|Secondary|Number of Participants With Clinical Response and Outcome at the Final Follow up Visit (Day 21-28)|The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as no increase in the total surface area of the lesion (as calculated by digital imaging) compared to post therapy visit and no further administration of antibacterial therapy for the lesion under study. Clinical recurrence was defined as death of participant; increase in the area of the lesion compared to post therapy visit or administration of additional antibacterial therapy for the lesion under study before the efficacy endpoint assessment for participants who were a clinical success at post therapy visit. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure.|Day 21 to Day 28|MITT population.|||Participants|||Count of Participants
2611263|NCT02045797|Secondary|Number of Participants With Clinical Response and Outcome at the Post Therapy Visit (Day 12-18)|The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as a reduction in the total surface area of the lesion (as calculated by digital imaging) of >=20% compared to Baseline and no administration of additional antibacterial therapy for the lesion under study. Clinical failure was defined as death of participant; increase or insufficient decrease (i.e., <20%) in the area (as calculated by digital imaging) of the lesion or administration of non-trial antibacterial drug therapy for treatment of the lesion under study before the primary efficacy endpoint assessment. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure.|Day 12 to Day 18|MITT population.|||Participants|||Count of Participants
2611264|NCT02045797|Secondary|Number of Participants With Clinical Response and Outcome at Early Efficacy Visit|The assessment was used to determine whether to continue the participant in the study. Clinical response was assessed as either a clinical success or a clinical failure and the clinical outcome was subsequently determined programmatically, based on the clinical response. Clinical success was defined as a reduction in the total surface area of the lesion (as calculated by digital imaging) of >=20% compared to Baseline and no administration of additional antibacterial therapy for the lesion under study. Clinical failure was defined as death of participant; increase or insufficient decrease (i.e., <20%) in the area (as calculated by digital imaging) of the lesion or administration of non-trial antibacterial drug therapy for treatment of the lesion under study before the primary efficacy endpoint assessment. In addition when the participant refused to consent to clinical examination, the clinical outcome was assessed as unable to determine with subsequent response as failure.|Up to Day 3|MITT population.|||Participants|||Count of Participants
2611265|NCT02045797|Primary|Number of Participants With Composite of the Cure Rate as Measured by Clinical Response and Outcome at the Early Efficacy Visit Combined With Withdrawal Rate|Cure rate and withdrawal rate data points was jointly assessed in a composite endpoint for all participants who received at least one dose of GSK2140944. Cure rate was defined as the percentage of participants exhibiting clinical improvement (=>20% reduction in overall lesion area) at the early efficacy visit. Withdrawal rate was defined as the percentage of participants who withdrew from study treatment due to a drug-related adverse event (AE) at any point while on treatment.|Up to Day 3|Modified Intent-to-Treat (MITT) population consisted of all randomized participants who received at least one dose of study medication.|||Participants|||Count of Participants
2611266|NCT02045732|Secondary|Concentration of PF-06342674||Baseline through Day 127/Early Termination|Participants in the placebo arm did not receive PF-06342674. Due to the early termination of the study, the small enrollment number and minimal data, concentration data were listed but not summarized, and pharmacokinetic (PK) parameters were not calculated for the PF-06342674 0.25 mg/kg arm.|||nanogram/milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
2611267|NCT02045732|Primary|Number of Participants With Confirmed Positive Anti-Drug Antibodies (ADAs)|Assays for the determination of a positive immune response was performed. An antibody immune response was defined as a confirmed post-treatment positive enzyme-linked immunosorbent assay (ELISA) result in combination with a negative baseline sample ELISA result. ADA positive was defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) >=4.32.|Baseline, and Days 15, 29, 57, 85 and Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.|||participants|||Number
2611268|NCT02045732|Primary|Number of Participants With Abnormal Electrocardiogram (ECG)|Criteria for potential clinical concern in ECG parameters: The maximum of the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) >=450 milliseconds (msec), maximum QTcF interval change from baseline in range of 30 to <60 msec and >=60 msec.|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug. The QTcF interval of the participant in the placebo arm was in this range of 450 to <480 msec at Baseline. This participant experienced a decrease in QTcF of 30 to <60 msec on Day 30, which then returned to baseline levels on Day 57.|||participants|||Number
2611269|NCT02045732|Primary|Number of Participants With Clinically Significant Changes in Vital Signs|Categorical summarization criteria in vital signs included: supine systolic blood pressure (SBP) of <90 millimeters of mercury (mm Hg) or change in supine SBP of >=30 mm Hg; supine diastolic blood pressure (DBP) of <50 mm Hg or change in supine DBP of >=20 mm Hg; supine pulse rate of <40 or more than (>)120 beats per minute (bpm).|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.|||participants|||Number
2611287|NCT02045264|Primary|Total Body Clearance (CL/F) of Icatibant|The rate at which a drug is removed from the body.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||mL/hr||Standard Deviation|Mean
2611357|NCT02044510|Secondary|Patient Reported Outcome Measure-NBSS|The Neurogenic bladder symptom score (NBSS) is a symptom specific measure of urinary symptoms developed for patients with neurogenic bladder dysfunction with demonstrated validity and reliability. Minimum score is 0, maximum score is 74. Higher score is worse neurogenic bladder symptoms.|10 weeks|||||||
2611270|NCT02045732|Primary|Number of Participants With Clinical Laboratory Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function, renal function, electrolytes, hormones, clinical chemistry, and urinalysis (dipstick and microscopy). Abnormal laboratory findings included: lymphocytes (absolute) less than (<)0.8 x lower limit of normal (LLN); urine blood/hemoglobin (qualitative) more than or equal to (>=)1; urine nitrite >=1; urine leukocyte esterase >=1; urine red blood cell (RBC) >=20/high-power field (HPF).|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.|||participants|||Number
2611271|NCT02045732|Primary|Number of Treatment-Emergent AEs and SAEs by Severity|AE severity was graded as mild, moderate, or severe. Mild AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function.|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.|||adverse events|||Number
2611272|NCT02045732|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to Day 127/Early Termination that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline through Day 127/Early Termination|The safety analysis population consists of all participants who received at least 1 dose of study drug.|||participants|||Number
2611273|NCT02045511|Secondary|Change From Baseline in SF-36 Physical Component at 3 Months|"Mean change, Unpooled - comparing baseline to 3 month follow-up visit~Measure collected via one-on-one interview conducted by trained data collectors.~Standard scoring can be found at http://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html.~Higher scores indicate better physical health functioning; U.S. population norm: M = 50, SD = 9.95, range = [4-71]."|3 months||||units on a scale||Standard Deviation|Mean
2611274|NCT02045511|Secondary|Change From Baseline in SF-36 Mental Component at 3 Months|"Mean change, Unpooled - comparing baseline to 3 month follow-up visit~Data were collected via one-on-one interviews with trained data collectors.~Standard scoring can be found at http://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html.~Higher scores indicate better mental health functioning; U.S. population norm: M = 50.0, SD = 10.0, range = [2-74]."|3 months||||units on a scale||Standard Deviation|Mean
2611275|NCT02045511|Secondary|Change From Baseline in PHQ-9 at 3 Months|"Mean change, Unpooled - comparing baseline to 3 month follow-up visit~[1] Measure Description: Measure collected via one-on-one interview conducted by trained data collectors.~Total of 9 questions, scored from 0 to 3. The score from each question are summed to a total score, which can range from 0 to 27.~Interpretation of Total Score Total Score Depression Severity 0 No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression.~Change from baseline to 3 months was reported. An increase in the score from baseline to three months (a positive number) indicates a worsening in depression severity. A decrease in the score from baseline to three months (a negative number) indicates a reduction in depression severity."|3 months||||units on a scale||Standard Deviation|Mean
2611276|NCT02045511|Secondary|Change From Baseline in Revised UCLA at 3 Months|"Mean change, Unpooled - comparing baseline to 3 month follow-up visit~[1] Measure Description: Measure was collected via a one-on-one interview conducted by a trained data collector.~20-item Likert-type scale. Total score is sum of the 20 items, scores range from 20 to 80. Lower values equate to lower levels of loneliness and higher values equate to higher levels of loneliness.~Perry et al., 1990 uses the following score ranges:~20-34 - Low degree of loneliness 35-49 - Moderate degree of loneliness 50-64 - Moderately high degree of loneliness 65-80 - High degree of loneliness"|3 months||||units on a scale||Standard Deviation|Mean
2611277|NCT02045511|Secondary|Change From Baseline in Revised QDS at 3 Months|"Mean change, Unpooled - comparing baseline to 3 month follow-up visit~[1] Measure Description: Measure was collected through a one-on-one interview conducted by a trained data collector.~Survey includes 5 questions, scored Strongly disagree, Slightly disagree, neither, slightly agree, or strongly agree (1, 2, 3, 4, 5)~Scoring is from 1 (worst) to 5 (best). Scores were summed across each of the 5 survey questions resulting in a total range of 5 (worst) to 25 (best)~Although utilized in multiple studies, including Yueh et al., 2001, there are no numerical anchors for what would represent a clinically important difference."|3 months||||units on a scale||Standard Deviation|Mean
2611278|NCT02045511|Primary|Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE)-S at 3 Months|"Mean change, Unpooled - comparing baseline to 3 month follow-up visit~Measure Description: Measure was collected through a one-on-one interview with a trained data collector.~Scoring:~0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap"|3 months||||units on a scale||Standard Deviation|Mean
2611279|NCT02045433|Primary|Time Taken to Induce Primary Tumor Control|The primary objective is to improve primary tumor local control of eligible LACC using SABR as the mechanism for delivering boost therapy to 85% at 2 years post treatment|2 years||||daya||95% Confidence Interval|Median
2611280|NCT02045264|Secondary|Change From Baseline in Pulse Rate||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.|||beats per minute||Standard Deviation|Mean
2611281|NCT02045264|Secondary|Change From Baseline in Systolic Blood Pressure||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.|||mmHg||Standard Deviation|Mean
2611282|NCT02045264|Secondary|Change From Baseline in Diastolic Blood Pressure||Over 48 hours post-dose|The Safety Set consisted of all subjects who had taken the single dose of icatibant.|||mmHg||Standard Deviation|Mean
2611358|NCT02044510|Secondary|Quality of Life (Incontinence)|The I-QOL is an incontinence specific quality of life tool that has been shown to be a valid, reliable and responsive measurement among patients with neurogenic bladder dysfunction|10 weeks|||||||
2611288|NCT02045264|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of Icatibant and Metabolites|AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last non-zero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*hr/mL||Standard Deviation|Mean
2611289|NCT02045264|Primary|Drug Concentration Half-Life (T1/2) of Icatibant and Metabolites|The time it takes for the blood plasma concentration of a substance to halve.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||hr||Standard Deviation|Mean
2611290|NCT02045264|Primary|Time to Peak Plasma Concentration (Tmax) of Icatibant and Metabolites|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||hr||Standard Deviation|Mean
2611291|NCT02045264|Primary|Peak Plasma Concentration (Cmax) of Icatibant and Metabolites|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 48 hours post-dose|The Pharmacokinetic Set consisted of all subjects who had taken the single dose of icatibant and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng/mL||Standard Deviation|Mean
2611292|NCT02045238|Secondary|Incidence of Adverse Effects|Any adverse effects directly attributable to treatment shall be noted. Mere lack of improve or worsening of symptoms attributable to the disease clinical course will not be considered as adverse effects.|24 hours|Number of patients too small to achieve statistical significance|||participants|||Number
2611293|NCT02045238|Secondary|Rate of Readmission After Discharge|The mere attendance to the Emergency Department will not be isolately considered, as it may be due to a scheduled reevaluation.|5 days|||||||
2611294|NCT02045238|Secondary|Time to Discharge|Actual time to discharge was considered of secondary importance as it can be influenced by individual considerations like patient age or time of the day.|24 hours|||||||
2611295|NCT02045238|Primary|Time to Attain Discharge Criteria|Discharge criteria are: Room air saturation >94% AND respiratory rate < 60 AND Respiratory Distress Assessment Instrument (RDAI) score inferior than 4, maintained over a 4 hour period.|24 hours|||||||
2611296|NCT02045238|Primary|Rate of Admission|Patients staying longer than 24h are considered to be admitted to ward.|24 hours|Number of participants analyzed was too small to obtain statistic significance|||participants|||Number
2611297|NCT02045212|Primary|Changes Mean RNFL Thickness in NAION Eyes Change From Screening to Week 26|TMean RNFL thickness measured by OCT. The data are in microns, as measured with an Opko OCT machine.|26 weeks|Efficacy|||µm||Standard Error|Mean
2611298|NCT02045212|Primary|Changes in Visual Field Observed Following the Treatment|Visual field mean deviation (MD) changes from the screening at week 26 using with the HVF 24-2 FASTPAC program using the size III or Size V test stimulus|26 weeks|Efficacy|||dB||Standard Error|Mean
2611299|NCT02045212|Secondary|Number of Participants With Adverse Events Assessed by Vital Signs, Clinical Laboratory and Physical Exam|Safety and tolerability multiple ascending SC doses as assessed by adverse events, vital signs, clinical laboratory and physical exam|26/39 weeks||||participants|||Number
2611300|NCT02045212|Primary|Mean Increase From Baseline in ETDRS Letters Read at 26 Weeks and Off-drug Follow-up Visit|Best Corrected Visual Acuity (BCVA) was assessed at all the visits, with refraction as necessary. VA measurements were taken in a sitting position at a test distance of 4 meters using early treatment diabetic retinopathy study (ETDRS) charts.|26/39 weeks|Efficacy|||EDTRS Letters||Standard Error|Mean
2611301|NCT02045108|Primary|Drinks Per Drinking Day|Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.|Baseline||||drinks per drinking day||Standard Deviation|Mean
2611302|NCT02045108|Primary|Alcohol Approach Bias|For each participant, bias is computed by taking the median response times to approaching alcohol pictures - response times to avoiding alcohol pictures, as measured with a pull or push of a joystick. Group means of these medians are presented as the outcome measure.|1 week after treatment|Three participants in the Sham TDCS/Active Retraining, one participant in the Active TDCS/Sham retraining, and one participant in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data.|||milliseconds||Standard Deviation|Mean
2611303|NCT02045108|Primary|Drinks Per Drinking Day|Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.|8 weeks post-baseline|Two participants in the Active TDCS/Active Retraining, four participants in the Sham TDCS/Active Retraining, two participants in the Active TDCS/Sham retraining, and three participants in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data.|||standard drinks||Standard Deviation|Mean
2611304|NCT02045108|Primary|Drinks Per Drinking Day|Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.|5 weeks post-baseline|One participant in the Active TDCS/Active Retraining, three participants in the Sham TDCS/Active Retraining, two participants in the Active TDCS/Sham retraining, and one participant in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data.|||standard drinks||Standard Deviation|Mean
2611359|NCT02044510|Secondary|Quality of Life (Bladder Specific)|The Short Form-Qualiveen is a urinary specific quality of life measure developed and studied specifically for neurogenic bladder patients; validity, reliability and responsiveness have been established.|10 weeks|||||||
2611305|NCT02045108|Primary|Drinks Per Drinking Day|Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.|4 weeks post-baseline|One participant in the Active TDCS/Active Retraining, three participants in the Sham TDCS/Active Retraining, two participants in the Active TDCS/Sham retraining, and one participant in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data.|||standard drinks||Standard Deviation|Mean
2611306|NCT02045108|Primary|Drinks Per Drinking Day|Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.|3 weeks post-baseline|Two participant in the Sham TDCS/Active Retraining, two participants in the Active TDCS/Sham retraining, and one participants in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data.|||standard drinks||Standard Deviation|Mean
2611307|NCT02045108|Primary|Drinks Per Drinking Day|Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.|2 weeks post-baseline|Two participants in the Active TDCS/Sham retraining and one participant in the Sham TDCS/Active Retraining condition failed to show up for this appointment and therefore were not included in the summary data.|||standard drinks||Standard Deviation|Mean
2611308|NCT02045108|Primary|Drinks Per Drinking Day|Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day since the last administration of the Timeline Follow-back. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.|1 week post-baseline||||standard drinks per drinking day||Standard Deviation|Mean
2611309|NCT02045108|Primary|Alcohol Approach Bias|For each participant, bias is computed by taking the median response times to approaching alcohol pictures - response times to avoiding alcohol pictures, as measured with a pull or push of a joystick. Group means of these medians are presented as the outcome measure.|Baseline||||milliseconds||Standard Deviation|Mean
2611310|NCT02045108|Primary|Drinks Per Drinking Day|Number of standard drinks will be assessed using the Timeline Follow-back method to obtain the number of drinks consumed on each day of the prior 30 days. Drinks per drinking day will be the mean number of drinks consumed on days on which alcohol was consumed.|Screening Visit|At-risk alcohol drinkers ages 21-30|||drinks per drinking day||Standard Deviation|Mean
2611311|NCT02045095|Secondary|Duration of Response|Duration of any response (CR or PR) was defined as the time (in both days and months) from the date of first documented response per the investigator response assessment to the date of first progressive disease after the first documented response or, if the participant discontinues treatment, the date of last disease assessment as per RECIST version 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target and non target) must have reduction in short axis to <10 mm. PR: at least 30% decrease in sum of diameter of target lesions, taking as reference baseline sum of diameter.|Baseline up to end of study (approximately 7 months)|The response-evaluable population where baseline and post-baseline assessments were available. The Response-evaluable population included all participants who received at least 1 dose of TAK-243, have measurable disease at baseline, and have at least 1 post baseline disease assessment.|||months||Full Range|Median
2611312|NCT02045095|Secondary|Percentage of Participants With Best Overall Response|Best overall response for participant is best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target and non target) must have reduction in short axis to less than (<) 10 millimeter (mm). Partial Response (PR): at least 30 percent (%) decrease in sum of diameter of target lesions, taking as reference baseline sum of diameter. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest sum of diameter; PD: at least 20% increase in sum of diameter of target lesions, taking as reference, smallest sum on study (this includes baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least mm. The appearance of 1 or more new lesions is also considered progression.|Baseline up to end of study (approximately 7 months)|The response-evaluable population included all participants who received at least 1 dose of TAK-243, have measurable disease at baseline, and have at least 1 post baseline disease assessment.|||percentage of participants|||Number
2611313|NCT02045095|Secondary|Change From Baseline in IHC Biomarkers in Tumor Biopsies at C1D12 as Assessed by Positive Index|The pharmacodynamics IHC biomarkers included polyubiquitin marker and Ub-histone H2B marker. Positive index was calculated by taking the number of positive cells over the total number of cells.|Baseline and Cycle 1 Day 12|Pharmacodynamic population:baseline,post-baseline assessments were available,including all participants who received all doses(Cycle 1),have pre-post dose paired tumor tissue biopsies taken at protocol-specified timepoints,have sufficient tumor content at both timepoints to estimate changes in Pharmacodynamic biomarker percent area positive values.|||percentage of cell||Standard Deviation|Mean
2611330|NCT02044991|Secondary|Disability|Disability is measured at baseline (0 weeks) and week 8 using the Oswestry Disability Index (ODI), which is a measure of low back pain that ranges from 0 points to 100 with higher scores indicating greater disability. The change in disability between these two time points (i.e., the difference score) is compared between the two groups.|8 weeks|The trial was prematurely terminated in February 2017 due to poor recruitment. No statistical analysis is conducted.|||change score on the ODI scale||Full Range|Median
2611331|NCT02044991|Secondary|Pelvic Functioning|Pelvic functioning is measured at baseline (0 weeks) and week 8 using the Pelvic Girdle Questionnaire (PGQ), which ranges from 0 to 100 points with higher scores revealing greater pelvic girdle pain. The change in pelvic functioning between these two time points (i.e., the difference score) is compared between the two groups.|8 weeks|The trial was prematurely terminated in February 2017 due to poor recruitment. No statistical analysis is conducted.|||change score on the PGQ scale||Full Range|Median
2611360|NCT02044510|Secondary|24hr Urinary Pad Weights|This will determine the amount of urinary incontinence that occurs over a 24hr period.|10 weeks|||||||
2611314|NCT02045095|Secondary|Change From Baseline in Immunohistochemistry (IHC) Biomarkers in Tumor Biopsies at Cycle 1 Day 12 (C1D12) as Assessed by Histological Score (H-score)|The pharmacodynamics IHC biomarkers included polyubiquitin marker and ubquityl (Ub)-histone H2B marker. H-score was a composite score that comprised of intensity and percentage of staining and was used for assessing the amount of protein or phospho-protein present in a biopsy sample. The composite score obtained by H-score is derived by summing the percentages of cell staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+; where 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). The composite H-score ranges from 0 to 300, with a score of 0 representing the absence of any of the target protein and an H-score of 300 representing maximum staining and intensity of the target protein.|Baseline and Cycle 1 Day 12|Pharmacodynamic population:baseline,post-baseline assessments were available,including all participants who received all doses(Cycle 1),have pre-post dose paired tumor tissue biopsies taken at protocol-specified timepoints,have sufficient tumor content at both timepoints to estimate changes in Pharmacodynamic biomarker percent area positive values.|||score on a scale||Standard Deviation|Mean
2611315|NCT02045095|Secondary|Terminal Phase Elimination Half-life (T1/2) for TAK-243||Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 72 hours) post-dose|The plasma PK analysis population where data at specified time points was available. The plasma PK-evaluable population included all participants who have sufficient dosing and concentration-time data to reliably estimate PK parameters.|||hour||Standard Deviation|Mean
2611316|NCT02045095|Secondary|Fet: Percentage of TAK-243 Excreted Unchanged in Urine||Cycle 1 Day 1; Cycle 1 Day 11|No data were collected as no participant was analyzed since study was terminated before the planned expansion phase.||||||
2611317|NCT02045095|Secondary|Aet: Amount of TAK-243 Excreted Unchanged in Urine||Cycle 1 Day 1; Cycle 1 Day 11|No data were collected as no participant was analyzed since study was terminated before the planned expansion phase.||||||
2611318|NCT02045095|Secondary|Vss: Volume of Distribution at Steady State for TAK-243||Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 72 hours) post-dose|The plasma PK analysis population where data at specified time points was available. The plasma PK-evaluable population included all participants who have sufficient dosing and concentration-time data to reliably estimate PK parameters.|||liter||Standard Deviation|Mean
2611319|NCT02045095|Secondary|CL: Total Clearance After Intravenous Administration for TAK-243||Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 72 hours) post-dose|The plasma PK analysis population where data at specified time points was available. The plasma PK-evaluable population included all participants who have sufficient dosing and concentration-time data to reliably estimate PK parameters.|||liter per hour (L/hr)||Standard Deviation|Mean
2611320|NCT02045095|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-243||Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 72 hours) post-dose|The plasma PK analysis population where data at specified time points was available. The plasma PK-evaluable population included all participants who have sufficient dosing and concentration-time data to reliably estimate PK parameters.|||ng*hr/mL||Standard Deviation|Mean
2611321|NCT02045095|Secondary|AUCτ: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for TAK-243||Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 72 hours) post-dose|The plasma PK analysis population where data at specified time points was available. The plasma PK-evaluable population included all participants who have sufficient dosing and concentration-time data to reliably estimate PK parameters.|||ng*hr/mL||Standard Deviation|Mean
2611322|NCT02045095|Secondary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-243||Cycle 1 Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose; Cycle 1 Day 11 pre-dose and at multiple time points (up to 72 hours) post-dose|The plasma PK analysis population where data at specified time points was available. The plasma PK-evaluable population included all participants who have sufficient dosing and concentration-time data to reliably estimate PK parameters.|||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
2611323|NCT02045095|Secondary|Ceoi: Plasma Concentration at the End of Infusion for TAK-243||Cycle 1 Day 1 and 11: pre-infusion to end of infusion (up to 10 minutes)|The plasma pharmacokinetic (PK) analysis population where data at specified time points was available.The plasma PK-evaluable population included all participants who have sufficient dosing and concentration-time data to reliably estimate PK parameters.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2611324|NCT02045095|Primary|Number of Participants With TEAEs Related to Tropinin I and T||Baseline up to 30 days after last dose of study drug (Cycle 10 Day 41)|The safety population included all participants who received at least 1 dose of TAK-243.|||participants|||Number
2611325|NCT02045095|Primary|Number of Participants With Clinically Significant Echocardiogram Abnormalities||Cycle 1 Day 2 up to 30 days after last dose of study drug (Cycle 10 Day 41)|The safety population included all participants who received at least 1 dose of TAK-243.|||participants|||Number
2611326|NCT02045095|Primary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities||Cycle 1 Day 1 up to Cycle 1 Day 11|The safety population included all participants who received at least 1 dose of TAK-243.|||participants|||Number
2611327|NCT02045095|Primary|Number of Participants With Vital Sign Related TEAEs by Preferred Term (PT)||Baseline up to 30 days after last dose of study drug (Cycle 10 Day 41)|The safety population included all participants who received at least 1 dose of TAK-243.|||participants|||Number
2611328|NCT02045095|Primary|Number of Participants With Laboratory Related TEAEs by System Organ Class (SOC)||Baseline up to 30 days after last dose of study drug (Cycle 10 Day 41)|The safety population included all participants who received at least 1 dose of TAK-243.|||participants|||Number
2611329|NCT02045095|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||Baseline up to 30 days after last dose of study drug (Cycle 10 Day 41)|The safety population included all participants who received at least 1 dose of TAK-243.|||participants|||Number
2611332|NCT02044991|Primary|Change in Pain|Pain is measured using the Pain Numeric Rating Scale (NRS), which ranges from 0 to 10 with higher scores indicating greater pain. This measure is recorded at baseline (0 weeks) and 8 weeks. The change in pain between these two time points (i.e., the difference score) is compared between the two groups.|8 weeks|The trial was prematurely terminated in February 2017 due to poor recruitment. No statistical analysis is conducted.|||change score on the NRS pain scale||Full Range|Median
2611333|NCT02044874|Secondary|Body Weight|Change in body weight from Week 1 (baseline) to Week 12|Baseline to Week 12|Modified Intent-to-Treat: All randomized patients, who received at least 1 dose of study medication, had a baseline measurement, and have a post-randomization measurement|||Kg||95% Confidence Interval|Least Squares Mean
2611334|NCT02044874|Secondary|The 7 Day Point Prevalence or Weekly Abstinence at Week 12|The CO (carbon monoxide)-confirmed continuous abstinence rate at for the 7-day period preceding the Week 12 visit, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm|Week 12|Modified Intent-to-Treat: All randomized patients, who received at least 1 dose of study medication, had a baseline measurement, and have a post-randomization measurement|||percentage of paticipants|||Number
2611335|NCT02044874|Secondary|The 7 Day Point Prevalence or Weekly Abstinence at Week 8|The CO (carbon monoxide)-confirmed continuous abstinence rate at for the 7-day period preceding the Week 8 visit, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm|Week 8|Modified Intent-to-Treat: All randomized patients, who received at least 1 dose of study medication, had a baseline measurement, and have a post-randomization measurement|||percentage of participants|||Number
2611336|NCT02044874|Secondary|Abstinence During Weeks 3-12|The CO (carbon monoxide)-confirmed continuous abstinence rate for Weeks 3 through 12, defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm|Week 3 to Week 12|Modified Intent-to-Treat: All randomized patients, who received at least 1 dose of study medication, had a baseline measurement, and have a post-randomization measurement|||percentage of participants|||Number
2611337|NCT02044874|Primary|Percentage of Participants With Abstinence for the Last 4 Weeks of Treatment From Weeks 9-12|Primary efficacy was assessed as the CO (carbon monoxide)-confirmed continuous abstinence rate for the last 4 weeks of treatment (Month 3: Weeks 9 through 12), defined as no reported smoking (not even a puff) or other nicotine use, verified by end expiratory CO levels <= 10 ppm.|Week 9 - Week 12|Modified Intent-to-Treat: All randomized patients, who received at least 1 dose of study medication, had a baseline measurement, and have a post-randomization measurement|||percentage of participants|||Number
2611338|NCT02044848|Primary|Stimulated C-peptide in Response to a Standard Mixed Meal Tolerance Test|Study was terminated and no data were collected for the Outcome Measure.|Week 52|Study was terminated and no data were collected for the Outcome Measure||||||
2611339|NCT02044822|Secondary|Minimal Residual Disease Negativity Rate at Week 36|Minimal residual disease (MRD) negativity rate was defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of rituximab after the original scheduled date, the MRD assessment will be performed no fewer than 12 weeks after the last dose of rituximab.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
2611340|NCT02044822|Secondary|Overall Survival|Overall survival was defined as the interval from the start of study treatment to death from any cause.||Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.||||||
2611341|NCT02044822|Secondary|Progression-Free Survival|Progression-free survival (PFS) was defined as the interval from first dose of study drug to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
2611342|NCT02044822|Secondary|Complete Response Rate|Complete response rate was defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
2611343|NCT02044822|Secondary|Nodal Response Rate|Nodal response rate was defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
2611344|NCT02044822|Secondary|Duration of Response|Duration of response (DOR) was defined as the interval from the first documentation of confirmed complete response or partial response (by IRC) to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is chronic lymphocytic leukemia (CLL) progression based on standard criteria, excluding lymphocytosis alone.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
2611345|NCT02044822|Primary|Overall Response Rate|Overall response rate (ORR) was defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an independent review committee (IRC).||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
2611346|NCT02044796|Secondary|Remission Rate (Complete Remission and Complete Remission With Incomplete Platelet Count Recovery) of This Regimen in Patients With Relapsed/Refractory Disease (Phase II)||Up to 5 years|Per the protocol, the 6 patients enrolled in the Phase 1 portion and treated at the MTD dose (16 mg/m^2) were included in the analysis of the Phase 2 remission rate.|||Participants|||Count of Participants
2611347|NCT02044796|Secondary|Overall Survival (Phase II)|Number of subjects that have survived|From date of randomization until the date of death from any cause, assessed up to 12 months||||Participants|||Number
2611364|NCT02044458|Secondary|Pain Assessed by Visual Analog Scale (VAS)|To compare the pain assessed by visual analogue scale(VAS), in women randomly allocated to ridged stylette or no ridged stylette. Patient-assessed pain level was determined by verbally asking patients to assess their pain (on a scale from 0-10 [no pain-worst pain]) following taping of the catheter tail. Pain was only assessed once.|Followed throughout patient's hospital stay, approximately 10 days|The pain level of one successful attempt with stylette was not recorded.|||units on a scale||95% Confidence Interval|Mean
2611365|NCT02044458|Primary|Duration of Insertion Between Foley Catheter Groups With and Without a Stylette.|Difference in insertion times between women randomly allocated to ridged stylette or no ridged stylette. Patient's may have experienced multiple insertions only if a patient failed initial randomized insertion method. Subsequent treatment methods were used when a patient failed and time was summarized as length of time of attempt. Failure was defined as either inadvertent amniotomy, excessive time in placement (subjectively determined by the provider using the catheter), or excessive patient pain (subjectively defined by the provider but based on patient response).|Followed throughout patient's hospital stay, approximately 10 days|The insertion time of two failed attempts with no stylette were not recorded.|||minutes||Inter-Quartile Range|Median
2611366|NCT02044419|Primary|λz|Elimination rate constant estimated from individual linear regression of the terminal part of the log concentration vs time curve of lomitapide and its metabolites (M1& M3).|predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose|Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data|||1/h||Standard Deviation|Mean
2611367|NCT02044419|Primary|AUC0-∞|Area under the plasma concentration vs time curve from zero to infinity of lomitapide and its metabolites (M1& M3).|predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose|Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data|||ng*h/mL||Standard Deviation|Mean
2611368|NCT02044419|Primary|t1/2|Terminal elimination half-life of lomitapide and its metabolites (M1& M3).|predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose|Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data|||h||Standard Deviation|Mean
2611369|NCT02044419|Primary|Tmax|Time to reach maximum plasma concentration of lomitapide and its metabolites (M1& M3).|predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose|Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data|||hours||Full Range|Median
2611370|NCT02044419|Primary|Cmax|Maximum observed concentration of lomitapide and its metabolites (M1& M3).|predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose|Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data|||ng/mL||Standard Deviation|Mean
2611371|NCT02044419|Primary|AUC0-t|Area under the concentration-time curve from hour 0 to the last measurable concentration of lomitapide and its metabolites (M1& M3).|predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post-dose|Pharmacokinetic Analysis Set included all subjects who received at least one single dose of lomitapide and who had evaluable PK data|||ng*h/mL||Standard Deviation|Mean
2611372|NCT02044393|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 Extrapolated to Infinity)|AUC0-infinity (area under the concentration-time curve of BI 691751 in plasma and whole blood over the time interval from 0 extrapolated to infinity).|from day 1 to 31 days postdose relative to BI 691751 administration time: -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.|PKS|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2611373|NCT02044393|Primary|Cmax (Maximum Measured Concentration of BI 691751 in Plasma and Whole Blood)|Cmax (maximum measured concentration of BI 691751 in plasma and whole blood).|From day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.|PKS|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2611374|NCT02044393|Primary|AUC0-tz (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 up to the Last Quantifiable Concentration)|AUC0-tz: area under the concentration-time curve of BI 691751 in plasma and whole blood over the time interval from 0 up to the last quantifiable concentration.|from day 1 to 31 days postdose relative to BI 691751 administration (h:min): -2:00, 0:10, 0:20, 0:40, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 47:00, 71:00, 95:00, 119:00, 143:00, 215:00, 287:00, 383:00, 551:00, 719:00h.|Pharmacokinetic Set (PKS): included all subjects from the TS who provided at least one primary or secondary pharmacokinetic endpoint in any period that is judged as evaluable for pharmacokinetics and is not affected by protocol violations relevant to the statistical evaluation of bioavailability|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2611375|NCT02044380|Primary|Safety Assesment|"Safety was assessed by:~All serious adverse events (SAEs)~All adverse events (AEs) leading to treatment discontinuation or dose reduction of afatinib~Non-serious AEs assessed by the treating physician as related to afatinib."|From first administration of treatment until 28 days after last drug administration, up to 80 weeks.|Treated set|||Percentage of participants|||Number
2611376|NCT02044367|Secondary|Palatability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.|"Palatability question: How do you rank the taste? with 5 possible answers: Very good - Good - Fair - Acceptable - Not acceptable."|once on day 3 (48 hours after first dose)|Treated set including all subjects that provided at least 1 observation for at least 1 of the questions for at least 1 of the test products.|||participants|||Number
2611377|NCT02044367|Secondary|Acceptability Rating for Pellets (on Food) and Oral Solution Will be Assessed by Asking the Subjects 1 Multiple Choice Verbal Question.|"Acceptability question: Would you accept to take this medication for chronic use? with 3 possible answers: Yes - No - I am not sure."|once on day 3 (48 hours after first dose)|Treated set including all subjects that provided at least 1 observation for at least 1 of the questions for at least 1 of the test products.|||participants|||Number
2611378|NCT02044367|Secondary|Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.|Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.|47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration|Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2611379|NCT02044367|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Free Dabigatran.|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for free dabigatran.|47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration|Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2611380|NCT02044367|Primary|Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.|Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.|47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration|Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2611381|NCT02044367|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t for Total Dabigatran.|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t for total dabigatran.|47:55, 48:30, 49:00, 49:30, 50:00, 50:30, 51:00, 51:30, 52:00, 54:00, 56:00, 58:00, 60:00 relative to first drug administration|Pharmacokinetic analysis set (PKS) included all treated subjects that provided at least 1 observation for at least 1 primary or secondary PK endpoint without relevant protocol deviations with respect to the statistical evaluation of PK endpoints.|||ng∙h/mL||Geometric Coefficient of Variation|Geometric Mean
2611382|NCT02044302|Secondary|Pain Score Questionnaire|The patient records their feeling of pain scaled in a subjective scale from 0 to 10. 0 means that there is no pain and 10 means that the worst pain. The other numbers mean that pain is perceived as in between. The investigator will also mark a pain score in the facial expression scale of Mosby© by evaluating your facial appearance.|Post Operation One Month|The study was terminated after 2 subjects enrolled and outcomes were never summarized.||||||
2611383|NCT02044302|Secondary|Pain Score Questionnaire|The patient records their feeling of pain scaled in a subjective scale from 0 to 10. 0 means that there is no pain and 10 means that the worst pain. The other numbers mean that pain is perceived as in between. The investigator will also mark a pain score in the facial expression scale of Mosby© by evaluating your facial appearance.|Post Operation Week 1|The study was terminated after 2 subjects enrolled and outcomes were never summarized.||||||
2611384|NCT02044302|Primary|Pain Score Questionnaire|The patient records their feeling of pain scaled in a subjective scale from 0 to 10. 0 means that there is no pain and 10 means that the worst pain you had. The other numbers mean that pain is in perceived as in between. The investigator will also mark a pain score in the facial expression scale of Mosby© by evaluating your facial appearance.|Post Operation Day 1|The study was terminated after 2 subjects enrolled and outcomes were never fully collected not summarized.||||||
2611385|NCT02044159|Secondary|Percentage of Patients for Whom Blood Samples Are Sent, and Successfully Received and Analyzed in Their Respective Labs|A total of 3 ml of blood in a red top tube will be collected within 24 hours of hospital admission. Patients with access for blood sampling and for whom consent has been obtained will have blood samples collected. The samples will be separated at each centre, stored until the end of the recruitment period, and then shipped to the principal investigators's centre as per the specific test requirements. The free cortisol and stratification biomarker samples will be batched and then shipped to Cincinnati for analysis at the end of the study. The number of samples collected, and the number of samples successfully received and analyzed at the principal investigator's site and at the Cincinnati lab will be determined at the end of the recruitment phase.|End of the study recruitment phase (up to 1.5 years)|The total number of patients in the full cohort for whom a study blod sample was collected, received and analyzed. This feasibility outcome, as stated a priori in the study protocol, was analyzed for the full cohort and was not compared between arms.|||Participants|||Count of Participants
2611386|NCT02044159|Secondary|Number of Participants With Incidence of Adverse Events and Mortality in the Full Cohort|The specific adverse events that will be measured include: severe bleeding, secondary infections and the use of insulin infusions. The incidence of adverse events and mortality rate was measured in aggregate (i.e. the whole cohort) in order to provide a better baseline estimate of these outcomes in our study population.|Daily during hospital admission (up to 28 days)|The number of participants with incidence of adverse events and mortality rate in the full cohort in order to provide a better baseline estimate of these outcomes in our study population.|||Participants|||Count of Participants
2611387|NCT02044159|Secondary|Time to Discontinuation of Vasoactive Infusions|The time to discontinuation of vasoactive agents will be used to better estimate the sample size for the full study.|Daily during hospital admission (up to 28 days)||||hours||Inter-Quartile Range|Median
2611388|NCT02044159|Secondary|Number of Patients Started on Open Label Steroids by the Treating Physician|We will consider the number of patients started on open label steroids by the treating physician to be acceptable if it occurs in less than 10% of patients. We will also collect information on the clinical parameters of patients when open label steroids are given.|7 days|The total number (and %) of patients in the full cohort who were administered open-label steroids by the treating physician.This feasibility objective, as stated a priori in the protocol, was not compared or reported separately by study arm.|||Participants|||Count of Participants
2611564|NCT02042924|Primary|Difference in Water Fat|The difference in the water-fat MRI between baseline and day 100 post transplant in L4 and femoral neck.|100 days|Only one patient was enrolled in each cohort and therefore any analysis would not be meaningful.||||||
2611389|NCT02044159|Secondary|1c. Discontinuation of Study Drug When Off All Vasoactive Medications|This objective is a measure of protocol adherence. The goal is to discontinue study drug within 12 to 18 hours of vasoactive medications being stopped. We will consider adherence to the protocol adequate if secondary outcomes 1a to 1c are met in 80% of enrolled patients.|7 days|The percentage of study drug doses that were administered correctly for the full cohort.This feasibility objective, as stated a priori in the protocol, was analyzed for the full study cohort and was not compared between arms.|||% of doses administered correctly|||Number
2611390|NCT02044159|Secondary|1b. Weaning of Study Drug to q8h When Patient is Hemodynamically Stable|This objective is a measure of protocol adherence. The goal is weaning of study drug to q8h within 12 hours of no escalation of therapy. We will consider adherence to our protocol to be adequate if secondary outcomes 1a to 1c are met in 80% of enrolled patients.|7 days|The percentage of study drug doses administered correctly was calculated for the full cohort.This feasibility objective was analyzed for the full cohort, and as stated a prior in our protocol, was not compared between study arms.|||% of doses administered correctly|||Number
2611391|NCT02044159|Secondary|1a. Time to Administration of the First Dose of Study Drug|This objective is a measure of protocol adherence. The goal is to have patients randomized within 6 hours, and study drug administration completed within 8 hours of starting a vasoactive medication. We will consider adherence to our protocol to be adequate if secondary outcomes 1a to 1c are met in 80% of enrolled patients.|8 hours from starting vasoactive medication|This feasibility objective, as stated a priori in the protocol, was analyzed for the full study cohort and was not compared between arms. Objective 1a was to determine the time to administration of the first dose of study drug for the full cohort.|||hours||Standard Deviation|Mean
2611392|NCT02044159|Primary|Patient Accrual Rate Over One Year (% of Target Sample Size Achieved)|The total number of participants recruited over the recruitment period to both arms (this was a feasibility outcome that was analyzed for the full cohort and, as stated a priori in the study protocol was not compared between study arms). Our goal is to recruit 72 patients over one year . However, we will consider patient accrual rate to be adequate if we recruit 60 patients from seven sites within this time period.|1 year|This feasibility objective, as stated a priori in the protocol, was analyzed for the full study cohort and was not compared between arms. The primary objective was the patient accrual rate over one year (percentage of for the target sample size for the full cohort that was achieved).|||percentage of target sample size|||Number
2611393|NCT02044094|Secondary|"Change From Placebo in VAS Score for Do You Feel Sedated? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"|"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme sedation 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages"|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2611394|NCT02044094|Secondary|"VAS Score for Do You Feel Sedated? by Study Week Analyzed by Mixed Model for Repeated Measures"|"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme sedation 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11."|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2611395|NCT02044094|Secondary|"Change From Placebo in VAS Score for Does the Drug Have Any Bad Effects? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"|"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme bad effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages"|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2611396|NCT02044094|Secondary|"VAS Score for Does the Drug Have Any Bad Effects? by Study Week Analyzed by Mixed Model for Repeated Measures"|"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme bad effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11."|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2611397|NCT02044094|Secondary|"Change From Placebo in VAS Score for Does the Drug Have Any Good Effects? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"|"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme good effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages"|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2611398|NCT02044094|Secondary|"VAS Score for Does the Drug Have Any Good Effects? by Study Week Analyzed by Mixed Model for Repeated Measures"|"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme good effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11."|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2611399|NCT02044094|Secondary|"Change From Placebo in VAS Score for Do You Feel Any Drug Effect? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"|"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme drug effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages"|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2611400|NCT02044094|Secondary|"VAS Score for Do You Feel Any Drug Effect? by Study Week Analyzed by Mixed Model for Repeated Measures"|"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme drug effect 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11."|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2611401|NCT02044094|Secondary|"Change From Placebo in VAS Score for How High Are You Right Now? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"|"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme high from the drug 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy 6 mg / 18 mg"|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2611402|NCT02044094|Secondary|"VAS Score for How High Are You Right Now? by Study Week Analyzed by Mixed Model for Repeated Measures"|"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme high from the drug 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11."|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2611430|NCT02043808|Secondary|Hemorrhagic Stroke|"Event rate of hemorrhagic stroke.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
2611403|NCT02044094|Secondary|"Change From Placebo in VAS Score for Do You Like the Drug? by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)"|"Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme liking of the drug 30 minutes before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo. For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: mean predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages"|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2611404|NCT02044094|Secondary|"Visual Analog Scale (VAS) Score for Do You Like the Drug? by Study Week Analyzed by Mixed Model for Repeated Measures"|"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme liking of the drug 30 minutes before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes after hydromorphone challenge. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11."|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2611405|NCT02044094|Secondary|Change From Placebo in Reinforcing Effects (Breakpoint) by Study Week and Simulated mu Opioid Receptor Occupancy (μORO)|"This endpoint explores the correlation between the reinforcing effects of hydromorphone and simulated mu opioid receptor occupancy.~Data are reported as change from placebo least square mean of Log10 transformed values for reinforcing effects. Reinforcing Effects tasks began >= 5 hours after hydromorphone challenge. Participants made 12 choices between a preference for working for the amount of hydromorphone dosed that day or for money. The hydromorphone break point value is assigned to the highest level of hydromorphone units earned, with 1 unit having a breakpoint value of 5 and 12 units with a value of 2160.~Change from placebo was calculated as Active Challenge result - Placebo Challenge result. Values that approach 0 (implying little difference between the Active Challenge result and the Placebo Challenge result) indicate effectiveness of the opioid blockade.~Row titles include Study Week: predicted mu opioid receptor occupancy for 6 mg / 18 mg challenge dosages"|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||log10 transformed ratio||95% Confidence Interval|Least Squares Mean
2611406|NCT02044094|Secondary|Predicted mu Opioid Receptor Occupancy (μORO) by Mean Buprenorphine Concentrations and Study Week|"A population pharmacokinetic/pharmacodynamic (PK/PD) model was developed to model the relationship between buprenorphine plasma concentrations and brain μORO based on 2 published clinical trials. This model used individual buprenorphine plasma concentrations measured to derive muORO individual predictions that were further described using summary statistics. The relationship between buprenorphine plasma concentration and μORO was best described by a maximal effect (Emax) model:~µORO = E(max)*Cp / EC(50) + Cp~Where Cp is the plasma concentration of buprenorphine, Emax is the maximal μORO, and EC50 is the plasma concentration of buprenorphine that is expected to achieve 50% of the maximal μORO. A direct (instantaneous) relationship between buprenorphine plasma concentration and µORO, i.e. without equilibration delay, was assumed.~Row title format: Study Week: buprenorphine plasma concentrations for placebo/ 6 mg / 18 mg challenge dosages"|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population|||percentage receptor occupancy||Standard Deviation|Mean
2611407|NCT02044094|Secondary|Plasma Concentrations of Buprenorphine Summarized by Study Week|"PK Sampling Schedule:~Day -17 to -15: before hydromorphone admin~Day -4: before Suboxone admin~Day 2: 24 hours after RBP-6000 admin~Days 5-7, 12-14, 19-21 and 26-28: immediately before hydromorphone admin~Days 29: before RBP-6000 admin~Day 30: 24 hours after RBP-6000 admin~Days 33-35, 40-42, 47-49, 54-56, 61-63, 68-70, 75-77, and 82-84: immediately before hydromorphone admin"|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT|||ng/mL||Standard Deviation|Mean
2611408|NCT02044094|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|"TEAE=any untoward medical occurrence that develops or worsens in severity after administration of study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required intervention to prevent one of the outcomes listed above.~All adverse events that occurred between Day 1 to Day 91 are reported under the Depot Buprenorphine treatment arm.~Adverse events that occurred on the day of a hydromorphone challenge are also reported under the appropriate hydromorphone challenge arm."|Depot Buprenorphine: Day 1 to Day 91. The three hydromorphone challenge levels were randomly assigned to one day in each of the three-day groupings spanning 12 weeks: Days 5-7, 11-14, 19-21, 26-28, 33-35, 40-42, 47-49, 54-56, 61-63, 68-70, 75-77, 82-84|Safety; one participant was administered the first RBP-6000 injection but no hydromorphone challenges. Investigators did not assess AEs for potential relatedness to hydromorphone.|||Participants|||Count of Participants
2611431|NCT02043808|Secondary|Ischemic Stroke|"Event rate of ischemic stroke.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period)|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
2611432|NCT02043808|Primary|Major Bleeding|"Event rate of major bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period)|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
2611409|NCT02044094|Secondary|Reinforcing Effects Of the Daily Randomized Hydromorphone Challenge as Measured by the Mean Hydromorphone Break Point Value at Weeks 1-12|"The ability of RBP-6000 to reduce the reinforcing effects of hydromorphone used money as a choice alternative to hydromorphone.~Reinforcing Effects Tasks began no earlier than 5 hours after randomised hydromorphone administration for each day. Each test consisted of the participant making 12 choices between a preference for working for the amount of hydromorphone dosed earlier that day or for money (each choice therefore has a scale of 0-12). The hydromorphone break point value is the ratio of the highest number of choices for hydromorphone to the highest number of choices for money. Hydromorphone breakpoint values were then analysed by week using a repeated measures mixed-effects model with period, hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect. Analyses were carried out on the log10 transformed hydromorphone breakpoint value."|Weeks 1 (Days 5-7), 2 (Days 12-14), 3 (Days 19-21), 4 (Days 26-28), 5 (Days 33-35), 6 (Days 40-42), 7 (Days 47-49), 8 (Days 53-56), 9 (Days 61-63), 10 (Days 68-70), 11 (Days 75-77), 12 (Days 82-84)|Intent to treat population|||log10 transformed ratio||Standard Error|Least Squares Mean
2611410|NCT02044094|Secondary|Reinforcing Effects (Breakpoint) by Study Week Analyzed by Mixed Model for Repeated Measures|"This outcome reports observed values used in the Change from Placebo....' endpoint that follows.~Reinforcing Effects tasks began >= 5 hours after hydromorphone challenge. Participants made 12 choices between a preference for working for the amount of hydromorphone dosed that day or for money. The hydromorphone break point value is assigned to the highest level of hydromorphone units earned, with 1 unit having a breakpoint value of 5 and 12 units with a value of 2160.~A repeated measures mixed-effects analysis of variance (ANOVA) was performed with the log transformed hydromorphone break point value as the dependent variable with period, hydromorphone sequence and hydromorphone dose as fixed effects, and subject nested within hydromorphone sequence as a random effect.~Blockade is achieved if the upper bound of the 95% confidence interval is <= to the non-inferiority margin of 11."|Baseline (Week -1), Weeks 1-12 (RBP-6000 admin on Weeks 1 and 5)|ITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2611411|NCT02044094|Primary|"Opioid Blockade Following Administration of Hydromorphone Challenge As Measured Using the Subjective Opioid Effects Rating for the Question Do You Like the Drug? Visual Analog Scale (VAS) at Weeks 1-4 Analyzed by Mixed Model for Repeated Measures"|"The study's primary objective was to determine if the opioid blocking effect for the first injection of buprenorphine 300 mg (RBP-6000) on Day 1 was not inferior to placebo when challenged by hydromorphone.~Participants completed a visual analog scale (VAS) that ranged from 0 - 100, with 0 meaning not at all, and 100 meaning the most extreme liking of the drug 30 minutes (± 5 minutes) before and 15, 30 , 45, 60, 75, 90, 120, 150, 180, 210, 240, 270, and 300 minutes (± 5 minutes) after hydromorphone administration on the challenge days listed in the time frame field. The drug in question was hydromorphone (6 or 18 mg) or placebo.~For each hydromorphone challenge week, a mixed-effects model with period (where period is day), hydromorphone sequence, and hydromorphone dose as fixed effects and subject nested within hydromorphone sequence as a random effect were used for analysis."|Weeks 1 (Days 5-7), 2 (Days 12-14), 3 (Days 19-21), 4 (Days 26-28)|The intent-to-treat (ITT) population included all subjects who received at least 1 dose of RBP-6000 and had at least 1 complete sequence (i.e., 0 mg [placebo], 6 mg and 18 mg hydromorphone in the randomised order) of hydromorphone challenges following administration of RBP-6000.|||units on a scale||Standard Error|Least Squares Mean
2611412|NCT02043938|Other Pre-specified|Propofol, Sevoflurane, and Remifentanil Interaction.|For all study groups (i.e. P, S, PR, and SR), the estimated PD model parameters that represent remifentanil interactions are Theta1 and Theta2, which are unit-less values. Theta1 and Theta2 are zero for all volunteers not receiving remifentanil. In case an interaction between remifentanil and propofol or sevoflurane exists, the estimate for Theta1 will be significantly different from zero. If the interaction in the 4 ng/mL group exceeds the estimated interaction for the 2 ng/mL group, Theta2 will be significantly higher than zero.|6 weeks|18 participants experienced the remifentanil 2 ng/mL intervention, and 18 participants experienced the remifentanil 4 ng/mL intervention.|||Index||Standard Error|Mean
2611413|NCT02043938|Other Pre-specified|Patient State Index (PSI) Comparison, C50 (Propofol, Propofol+Remifentanil)|Patient State Index (PSI-1) is a processed EEG parameter that quantifies the level of EEG inhibition. A new algorithm (PSI-2) has been created to improve performance in low power EEG. PSI is unitless. It ranges between 100 and 0 (100 representing 'awake state', 0 denoting 'no detectable electrical brain activity'). PSI-1 and PSI-2 were compared in their correlation with measured propofol and sevoflurane concentrations with or without remifentanil (0, 2 ,or 4 ng/mL) via several estimated PD model parameters. In the data table, BL (Baseline) denotes PSI-2 measurements when no drug is present; Emax denotes PSI in the presence of the maximum drug effect; C50 is the drug concentration which produces 50% of the maximal drug effect (ug/mL for Propofol C50, vol% for Sevoflurane C50).|6 weeks|All 36 participants experienced all four interventions: Propofol only (P), Sevoflurane only (S), Propofol with Remifentanil (PR), and Sevoflurane with Remifentanil (SR).|||ug/mL||Standard Error|Mean
2611414|NCT02043938|Other Pre-specified|Patient State Index (PSI) Comparison, C50 (Sevoflurane, Sevoflurane+Remifentanil)|Patient State Index (PSI-1) is a processed EEG parameter that quantifies the level of EEG inhibition. A new algorithm (PSI-2) has been created to improve performance in low power EEG. PSI is unitless. It ranges between 100 and 0 (100 representing 'awake state', 0 denoting 'no detectable electrical brain activity'). PSI-1 and PSI-2 were compared in their correlation with measured propofol and sevoflurane concentrations with or without remifentanil (0, 2 ,or 4 ng/mL) via several estimated PD model parameters. In the data table, BL (Baseline) denotes PSI-2 measurements when no drug is present; Emax denotes PSI in the presence of the maximum drug effect; C50 is the drug concentration which produces 50% of the maximal drug effect (ug/mL for Propofol C50, vol% for Sevoflurane C50).|6 weeks|All 36 participants experienced all four interventions: Propofol only (P), Sevoflurane only (S), Propofol with Remifentanil (PR), and Sevoflurane with Remifentanil (SR).|||%vol||Standard Error|Mean
2611468|NCT02043509|Primary|Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Biochemically Validated at Late Pregnancy.|The primary smoking outcome measure will be the number of participants reporting continuous abstinence from smoking from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation), validated by exhaled CO and/or saliva cotinine estimation at approximately 36 weeks gestation.|36 weeks gestation|All participants were included in analysis. Participants lost to follow up were assumed to be smoking.|||Participants|||Count of Participants
2611415|NCT02043938|Primary|Patient State Index (PSI) Comparison, Baseline and Emax|Patient State Index (PSI-1) is a processed EEG parameter that quantifies the level of EEG inhibition. A new algorithm (PSI-2) has been created to improve performance in low power EEG. PSI is unitless. It ranges between 100 and 0 (100 representing 'awake state', 0 denoting 'no detectable electrical brain activity'). PSI-1 and PSI-2 were compared in their correlation with measured propofol and sevoflurane concentrations with or without remifentanil (0, 2 ,or 4 ng/mL) via several estimated PD model parameters. In the data table, BL (Baseline) denotes PSI-2 measurements when no drug is present; Emax denotes PSI in the presence of the maximum drug effect; C50 is the drug concentration which produces 50% of the maximal drug effect (ug/mL for Propofol C50, vol% for Sevoflurane C50).|6 weeks|All 36 participants experienced all four interventions: Propofol only (P), Sevoflurane only (S), Propofol with Remifentanil (PR), and Sevoflurane with Remifentanil (SR).|||index||Standard Error|Mean
2611416|NCT02043860|Primary|Progression Free Survival No Results Due to 1 Subject Came Off Treatment Within 7 Days and 1 Subject Came Off Treatment Within 5 Days. Not Enough Data to Analyze|To evaluate progression free survival (PFS) and in patients with multiple myeloma undergoing autologous stem cell transplant using the combination of high dose melphalan and total marrow irradiation.|Up to 1 year post-transplant.|Data not collected||||||
2611417|NCT02043808|Secondary|Death|"Event rate of death, due to any cause.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
2611418|NCT02043808|Secondary|Pulmonary Embolism|"Event rate of pulmonary embolism.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
2611419|NCT02043808|Secondary|Deep Vein Thrombosis|"Event rate of deep vein thrombosis.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
2611420|NCT02043808|Secondary|Venous Thromboembolism|"Event rate of venous thromboembolism.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
2611421|NCT02043808|Secondary|Myocardial Infarction|"Event rate of myocardial infarction.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
2611422|NCT02043808|Secondary|Transient Ischemic Attack|"Event rate of transient ischemic attacks.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
2611423|NCT02043808|Secondary|Major Other Bleeding|"Event rate of major other bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
2611424|NCT02043808|Secondary|Major Urogenital Bleeding|"Event rate of major urogenital bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
2611425|NCT02043808|Secondary|Major Lower GI Bleeding|"Event rate of major lower gastrointestinal (GI) bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
2611426|NCT02043808|Secondary|Major Upper GI Bleeding|"Event rate of major upper gastrointestinal (GI) bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
2611427|NCT02043808|Secondary|Major GI Bleeding|"Event rate of major gastrointestinal (GI) bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
2611428|NCT02043808|Secondary|Major Extracranial Bleeding|"Event rate of major extracranial bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
2611429|NCT02043808|Secondary|Major Intracranial Bleeding|"Event rate of major intracranial bleeding.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period).|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
2611469|NCT02043379|Secondary|Lactic Acid||pre-operative through 24 hours post-operative||||mmol/L||Standard Deviation|Mean
2611433|NCT02043808|Primary|Stroke (Hemorrhagic, Ischemic)|"Event rate of stroke (hemorrhagic, ischemic).~Variables in the final propensity score model: age, gender index year, baseline CHADS(2) score (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Prior Stroke or transient ischemic attack (TIA) or Thromboembolism), baseline CHA(2)DS(2)-VASc score (Congestive heart failure, Hypertension, Age ≥75 years (doubled), Diabetes mellitus, Stroke (doubled), Vascular disease, Age 65-74 years, Sex category), baseline HAS-BLED score (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile International Normalized Ratio, Elderly, Drugs/alcohol concomitantly), baseline use of several medications and presence of several baseline co-morbidities.~The 12-month period prior to and including the index date was defined as the baseline period. Patients were required to have an NVAF diagnosis during this baseline period."|From October 1, 2009 through July 31, 2013 (the study period)|All patients in the post-propensity score matching cohort|||Events per 1000 person-years||95% Confidence Interval|Number
2611434|NCT02043782|Primary|Degree of Leakage|The degree of leakage is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage.|14 +/- 3 days||||units on a scale|Participants|Standard Deviation|Mean
2611435|NCT02043704|Other Pre-specified|Time to First Flatus/Bowel Movement|Length of time from the end of surgery to the time of first flatus or bowel movement.|9000 minutes||||minutes||Inter-Quartile Range|Median
2611436|NCT02043704|Secondary|Time to Ambulation|Length of time from the end of surgery to the time of ambulation.|1800 minutes||||minutes||Inter-Quartile Range|Median
2611437|NCT02043704|Secondary|Narcotic Associated Side Effects|The incidence of known narcotic associated side effects will be recorded for urinary retention.|24 hours||||Participants|||Count of Participants
2611438|NCT02043704|Secondary|Narcotic Associated Side Effects|The incidence of known narcotic associated side effects will be recorded for respiratory depression.|24 hours||||Participants|||Count of Participants
2611439|NCT02043704|Secondary|Narcotic Associated Side Effects|The incidence of known narcotic associated side effects will be recorded for shortness of breath.|24 hours||||Participants|||Count of Participants
2611440|NCT02043704|Secondary|Narcotic Associated Side Effects|The incidence of known narcotic associated side effects will be recorded for rash/hives.|24 hours||||Participants|||Count of Participants
2611441|NCT02043704|Secondary|Narcotic Associated Side Effects|The incidence of known narcotic associated side effects will be recorded for insomnia.|24 hours||||Participants|||Count of Participants
2611442|NCT02043704|Secondary|Narcotic Associated Side Effects|The incidence of known narcotic associated side effects will be recorded for headache.|24 hours||||Participants|||Count of Participants
2611443|NCT02043704|Secondary|Narcotic Associated Side Effects|The incidence of known narcotic associated side effects will be recorded for itching.|24 hours||||Participants|||Count of Participants
2611444|NCT02043704|Secondary|Time to First Rescue Narcotic|The time from the end of surgery to the time any IV narcotic is given.|24 hours||||minutes||Inter-Quartile Range|Median
2611445|NCT02043704|Secondary|Narcotic Associated Side Effects|The incidence of known narcotic associated side effects will be recorded for nausea/vomiting.|24 hours|Count reported for nausea/vomiting.|||Participants|||Count of Participants
2611446|NCT02043704|Primary|Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery|Hydromorphone will be administered for breakthrough pain. The total amount consumed in the first 24 hours post surgery will be recorded.|24 hours||||mgs||Inter-Quartile Range|Median
2611447|NCT02043704|Primary|Pain While Active - 18 hr|Post operative pain will be assessed 18 hours after surgery. Pain will be self reported by patients using a 0-100 mm visual analog scale (VAS) with 0 indicating no pain and 100 indicating the worst pain imaginable. A pain score will be collected for pain while active.|18 hours||||mm||Inter-Quartile Range|Median
2611448|NCT02043678|Secondary|Time to Opiate Use for Cancer Pain|Time to opiate use for cancer pain was defined as the interval from the date of randomization to the date of opiate use.|From randomization until the date of opiate use, up to 47 months|ITT analysis set excluding participants who had opiate use at baseline|||Months||95% Confidence Interval|Median
2611449|NCT02043678|Secondary|Time to Cytotoxic Chemotherapy|Time to cytotoxic chemotherapy is time (months) from randomization to the earliest date of the first cytotoxic chemotherapy. Participants who have not started cytotoxic chemotherapy during the study were censored at the last assessment date.|From randomization until the date of first cytotoxic chemotherapy, up to 47 months|ITT analysis set (included all randomized participants)|||Months||95% Confidence Interval|Median
2611450|NCT02043678|Secondary|Time to Pain Progression|Time to pain progression was defined as the interval from randomization to the first date a subject experienced pain progression, assessed by BPI-SF (see Baseline Characteristics) and defined as: an increase of 2 or more points in the average worst pain score (WPS) from baseline observed at 2 consecutive evaluations >= 4 weeks apart or initiation of short- or long-acting opioid use for pain for subjects with WPS 0 at baseline; an increase of 2 or more points in the average WPS from baseline observed at 2 consecutive evaluations ≥ 4 weeks apart and an average WPS of ≥ 4 OR initiation of short- or long-acting opioid use for pain for subjects with WPS 1 to 3 at baseline. Subjects without pain progression at the end of study are censored at the last date known to have not progressed: the last evaluation date for pain scores or last visit when recorded opiate use, whichever is last. Subjects with no on-study assessment or no baseline assessment are censored at the date of randomization.|From randomization until the date of pain progression based on pain score, up to 47 months|ITT analysis set (included all randomized participants)|||Months||95% Confidence Interval|Median
2611451|NCT02043678|Secondary|Radiological Progression Free Survival (rPFS)|rPFS was defined as the time (months) from the date of randomization to the date of confirmed radiological progression or death (if death occurred before progression) based on independent assessment.|From randomization until the date of confirmed radiological progression or death, up to 47 months|ITT analysis set (included all randomized participants)|||Months||95% Confidence Interval|Median
2611452|NCT02043678|Secondary|Overall Survival (OS)|OS was defined as the time (months) from the date of randomization to the date of death due to any cause. Subjects alive at the survival cut-off date were censored at the last date known to be alive.|From randomization until death from any cause, up to 47 months|ITT analysis set (included all randomized participants)|||Months||95% Confidence Interval|Median
2611453|NCT02043678|Primary|Symptomatic Skeletal Event Free Survival (SSE-FS)|SSE-FS was defined as time (months) from randomization to the earliest of onset date of skeletal symptoms treated with external beam radiotherapy (EBRT), onset date of pathological bone fracture, onset date of spinal cord compression, procedure date of tumor-related orthopedic surgery, or death from any cause. Subjects who died without prior SSE and ≥ 13 weeks after the last SSE assessment are censored at the last SSE assessment date. Subjects alive at the survival cut-off date are censored at the last date known to be alive. Subjects with multiple events are only counted for the category in which the first event occurred. If multiple SSE (component events) occur on the same date for 1 subject, the subject is only counted into 1 category in the order of: spinal cord compression > bone fracture > orthopedic surgery > EBRT.|From randomization until first onset of on-study symptomatic skeletal event (SSE) or death, up to 47 months|Intent-to-Treat (ITT) analysis set (included all randomized participants)|||Months||95% Confidence Interval|Median
2611454|NCT02043652|Secondary|Number of Patients Reporting Relapses|Evaluate the relapse rate, that is reappearance of parasites, for up to 6 months after treatment.|6 months||||Participants|||Count of Participants
2611455|NCT02043652|Primary|Number of Patients With Adequate Clearance of Parasites and Symptoms|Investigators, according to WHO guidelines, will evaluate patients at regular intervals to evaluate symptom and parasitemia clearance.|28 days||||Participants|||Count of Participants
2611456|NCT02043574|Secondary|The Change in Circulating Nitrotyrosine|Plasma will be used to quantitate circulating nitrotyrosine concentrations|measured at baseline and following 6 months of treadmill training or stretching (control)||||% change||Standard Deviation|Mean
2611457|NCT02043574|Secondary|The Change in Substrate Oxidation|After a 12 hour fast, economy of hemiparetic gait will be measured using open circuit spirometry during a standard constant load submaximal effort treadmill walking task at a pre-established gait velocity (60% of self-selected floor walking velocity). This slower walking velocity is selected because untrained subjects with stroke usually cannot maintain their self-selected walking pace, precluding steady state measures of oxygen consumption that defines gait economy. We will calculate the change in respiratory exchange ratio from rest to the final 3 minutes of a 10-minute walk under steady state oxygen consumption conditions (RER at 60%VO2peak-RER at rest). Subjects not achieving a plateau in VO2 will be re-tested at a lower velocity on a different date to eliminate potential confounding effects of fatigue on testing.|measured at baseline and following 6 months of treadmill training or stretching (control)||||ratio change||Standard Deviation|Mean
2611458|NCT02043574|Primary|The Change in Total Daily Energy Expenditure|Subjects will wear an accelerometer activity monitor on their belt for 5 to 7 days to determine caloric expenditure in daily activities.|measured at baseline and following 6 months of treadmill training or stretching (control)||||change in kcal/day||Standard Deviation|Mean
2611459|NCT02043509|Secondary|Number of Requests to Stop Text Support|The number of participants in the trial arm who discontinued the text support prematurely, from baseline until follow up at the end of pregnancy (approximately 36 weeks gestation).|36 weeks gestation|All participants allocated to the trial arm were included in analysis.|||Participants|||Count of Participants
2611460|NCT02043509|Secondary|Reported Use of NHS and Other (Non-trial) Cessation Support|Reported use of any NHS cessation support or other (non-trial) cessation support (e.g. non-NHS websites), from baseline until follow up at the end of pregnancy (approximately 36 weeks gestation).|36 weeks gestation|Outcomes are calculated out of 254 participants with response data at late pregnancy follow up (124 MiQuit, 130 Standard Care).|||Participants|||Count of Participants
2611461|NCT02043509|Secondary|Number of 24 Hour Quit Attempts|Number of short-term, 24 hour quit attempts noted per participant, from baseline until follow up at the end of pregnancy (approximately 36 weeks gestation).|36 weeks gestation|Outcomes are calculated out of 254 participants with response data at late pregnancy follow up (124 MiQuit, 130 Standard Care).|||number of events reported||Inter-Quartile Range|Median
2611462|NCT02043509|Secondary|7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Biochemically Validated at Late Pregnancy.|The number of participants reporting 7-day abstinence from smoking at both 4 weeks after randomisation and at follow up at the end of pregnancy (approximately 36 weeks gestation), validated by exhaled CO and/or saliva cotinine estimation at approximately 36 weeks gestation.|36 weeks gestation|All participants were included in analysis. Participants lost to follow up were assumed to be smoking.|||Participants|||Count of Participants
2611463|NCT02043509|Secondary|7-day Point Prevalence Abstinence From Smoking Reported at Both 4 Weeks Post-randomization and at Late Pregnancy, Self-report.|The number of participants reporting 7-day abstinence from smoking at both 4 weeks after randomisation and at follow up at the end of pregnancy (approximately 36 weeks gestation), self-reported.|36 weeks gestation|All participants were included in analysis. Participants lost to follow up were assumed to be smoking.|||Participants|||Count of Participants
2611464|NCT02043509|Secondary|7-day Point Prevalence Abstinence From Smoking Reported at 4 Weeks Post-randomization, Self-report.|The number of participants reporting 7-day abstinence from smoking at 4 weeks after randomisation, self-reported.|4 weeks post-randomisation|All participants were included in analysis. Participants lost to follow up were assumed to be smoking.|||Participants|||Count of Participants
2611465|NCT02043509|Secondary|7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Biochemically Validated.|The number of participants reporting 7-day abstinence from smoking at the end of pregnancy (approximately 36 weeks gestation), validated by exhaled CO and/or saliva cotinine estimation.|36 weeks gestation|All participants were included in analysis. Participants lost to follow up were assumed to be smoking.|||Participants|||Count of Participants
2611466|NCT02043509|Secondary|7-day Point Prevalence Abstinence From Smoking Reported at Late Pregnancy, Self-report.|The number of participants reporting 7-day abstinence from smoking at the end of pregnancy (approximately 36 weeks gestation), self-reported.|36 weeks gestation|All participants were included in analysis. Participants lost to follow up were assumed to be smoking.|||Participants|||Count of Participants
2611467|NCT02043509|Secondary|Continuous Abstinence From Smoking Reported From 4 Weeks Post-randomisation Until Late Pregnancy, Self-report.|The number of participants reporting continuous abstinence from smoking from 4 weeks after randomisation until follow up at the end of pregnancy (approximately 36 weeks gestation), self-reported.|36 weeks gestation|All participants were included in analysis. Participants lost to follow up were assumed to be smoking.|||Participants|||Count of Participants
2611480|NCT02043379|Secondary|Fluid Overload Variables|The following fluid overload variables will be assessed at 0-24 hours, 25-48 hours, and 0-48 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload.The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg.|0-48 hours post-CPB||||militers/kilogram||Inter-Quartile Range|Median
2611481|NCT02043379|Secondary|Intensive Care Unit Length of Stay|The length of stay in the pediatric cardiac intensive care unit from admit post-operative until either discharge home, discharge to another unit/hospital/care facility, or death. This value is calculated in hours. Admit post-operative is recorded as hour 0.|1 month||||hours||Inter-Quartile Range|Median
2611482|NCT02043379|Secondary|Mortality|Incidence of mortality from admit to Pediatric cardiac intensive care unit post-operatively until hospital discharge .|Approximately 1 month||||subjects|||Number
2611483|NCT02043379|Secondary|Immunoglobulin Concentration in Chest Tube Drainage|Immunoglobulin concentration will be measured from chest tube every 4 hours for first 12 hours post-operative and then 24 hours post-operative.|24 hours post-op||||mg/dL||Inter-Quartile Range|Median
2611484|NCT02043379|Secondary|Interferon-gamma Plasma Cytokine Levels|Plasma cytokine levels measured preoperatively, 0, 4, 12, 24 hours, and 48 hours post-operatively.|Pre-operative to 48 hours post-operative||||pg/mL||Inter-Quartile Range|Median
2611485|NCT02043379|Secondary|Plasma Immunoglobulins|Plasma Immunoglobulin levels will be checked pre-operatively, 12 hours post-op and 5 days post-op|5 days post-op||||mg/dL||Standard Deviation|Mean
2611486|NCT02043379|Secondary|Hospital Discharge|From admit post-operative to the Pediatric cardiac intensive care unit until discharge from the hospital in days.|Approximately 1 month||||days||Inter-Quartile Range|Median
2611487|NCT02043379|Secondary|Respiratory Variables|Alive, ventilator free days will be recorded at hospital discharge.|until Hospital Discharge, an average of 30 days||||days||Inter-Quartile Range|Median
2611488|NCT02043379|Secondary|Post-operative Inotrope Score|"The average admit, 12 hour, 24 hour, and 48 hour post-operative inotrope score will be calculated excluding Milrinone. To calculate the inotrope score the following formula was used: (Epinephrine/Norepinephrine dose in mcg/kg/min x 100) + (Dopamine dose in mcg/kg/min x 1) + (Phenylephrine dose in mcg/kg/min x 10) + (Vasopressin dose unit/kg/hr x 60/10000). The higher the inotrope score the more cardiac support the subject requires. There is not a normal scale or range used for this calculation."|first 48 hours post-CPB||||inotropic score||Inter-Quartile Range|Median
2611489|NCT02043379|Secondary|Fluid Overload Variables|The following fluid overload variables will be assessed in milliliters per kilogram at 0-24 hours post-cardiopulmonary bypass: blood product and albumin administration, chest tube output, urine output, peritoneal dialysis output, net fluid balance, and percent fluid overload. The total output the subject's produce (urine, chest tube, peritoneal drainage, etc.) will be subtracted from the total input (medications, blood products, albumin administration, etc) to determine the total fluid intake in milliliters. This total number will then be divided by the subject's weight in kilograms to determine the fluid overload in mL/kg.|0-24 hours post-CPB||||mililiters/kilogram||Inter-Quartile Range|Median
2611490|NCT02043379|Secondary|Post-operative Plasma Albumin|Plasma albumin will be assessed at 24 and 48 hours.|up to 48 hours post CPB||||g/dL||Standard Deviation|Mean
2611491|NCT02043379|Primary|Blood Stream Infection Within 1 Week of Surgery||7 days||||subjects|||Number
2611492|NCT02043379|Primary|Blood Stream Infection|Any positive blood culture during the post-operative period until hospital discharge|until Hospital Discharge, an average of 30 days||||subjects|||Number
2611493|NCT02043379|Primary|Post-operative Infection|Any positive culture or treatment for culture negative sepsis within 1 week of surgery|within 1 week of surgery||||Subjects|||Number
2611494|NCT02043379|Primary|Post-Operative Infections|The primary endpoint of this study is incidence of post-operative infections through hospital discharge|until Hospital Discharge, an average of 30 days||||subjects|||Number
2611495|NCT02043366|Secondary|Normalized Area of Hyperalgesia Around the Incision|The skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a 'painful', 'sore' or 'sharper' feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament.|24 hours after surgery||||cm^2||Standard Deviation|Mean
2611496|NCT02043366|Secondary|Cumulative Sufentanyl Consumption|Each patient was administered analgesics using a PCA pump containing sufentanil (100μg) in normal saline at a total volume of 100 ml after leaving PACU. This device was set to deliver a basal infusion of 2 ml/h and bolus doses of 0.5 ml with a 15-min lockout period. Sufentanyl cumulative consumption is recorded 24 hours postoperatively|24 hours|||||||
2611497|NCT02043366|Secondary|Total Dose of First Postoperative Analgesic Requirement|First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.|1 hour after surgery|||||||
2611498|NCT02043366|Secondary|Occurrence of Side Effects|Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus|24 hours|||||||
2611499|NCT02043366|Secondary|Time of First Postoperative Analgesic Requirement|First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.|1 hour post surgery|||||||
2611500|NCT02043366|Secondary|Pain Score (NRS)|The pain score at rest was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.|3h, 6h, 12h, and 24h after surgery|||||||
2611501|NCT02043366|Primary|Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm|The mechanical hyperalgesia threshold was defined as the lowest force (g) necessary to bend a Von Frey filament, which was perceived to be painful by the patient and measured by Von Frey filament at 24 hours postoperatively|24 hours after surgery||||g||Standard Deviation|Mean
2611502|NCT02043301|Secondary|Neutralizing Antibody (nAb) Titer|nAb titer: titers were presented as log2 reciprocal dilution at assay cutpoint.|Day 1, Day 15, Day 29, Day 57 and Day 85/Early Termination|The safety analysis population included all participants who received at least 1 dose of study medication. Only confirmed ADA positive samples were analyzed for nAb. nAb titer was determined if a sample is screened positive for nAb. nAb titer data for the Bococizumab 150 mg Upper Arm group is not presented as there were no nAb positive subjects.|||Log2 titer||Full Range|Median
2611503|NCT02043301|Secondary|Anti-Drug Antibody (ADA) Titer|ADA titer: titers were presented as log2 reciprocal dilution at assay cutpoint.|Day 1, Day 15, Day 29, Day 57 and Day 85/Early Termination|The safety analysis population included all participants who received at least 1 dose of study medication. Only confirmed ADA positive samples were analyzed for titer.|||Log2 titer||Full Range|Median
2611504|NCT02043301|Secondary|Number of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)|A participant is ADA positive if ADA titer (log2) >=6.23. A participant is nAb positive if nAb titer (log2) >=4.32.|Day 1, Day 15, Day 29, Day 57 and Day 85/Early Termination|The safety analysis population included all participants who received at least 1 dose of study medication.|||participants|||Number
2611505|NCT02043301|Secondary|Number of Participants With Injection Site Reactions (ISRs) by Severity|Acute injection site reactions (e.g, pain, pruritus, induration) were captured as adverse events (AEs). Intensity of the AE was described as mild (does not interfere with usual function), moderate (interferes to some extent with usual function), or severe (interferes significantly with participant's usual function).|Day 1 to Day 85|The safety analysis population included all participants who received at least 1 dose of study medication.|||participants|||Number
2611506|NCT02043301|Secondary|AUEC: Percent Change From Baseline|AUEC is the area under the LDL-C concentration-time curve from baseline to Day 85 expressed as percent change from baseline.|Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination|The PD analysis population included all enrolled participants who received at least 1 dose of study medication and had both baseline and post-baseline values for at least 1 of the PD endpoints. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Deviation|Mean
2611507|NCT02043301|Secondary|AUEC: Change From Baseline|AUEC is the area under the LDL-C concentration-time curve from baseline to Day 85 exprssed as change from baseline|Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination|The PD analysis population included all enrolled participants who received at least 1 dose of study medication and had both baseline and post-baseline values for at least 1 of the PD endpoints. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mg*day/dL||Standard Deviation|Mean
2611508|NCT02043301|Secondary|Area Under the LDL-C Effect Curve (AUEC): Absolute Value|AUEC is the area under the LDL-C concentration-time curve from baseline to Day 85 exprssed using absolute on trial value|Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination|The PD analysis population included all enrolled participants who received at least 1 dose of study medication and had both baseline and post-baseline values for at least 1 of the PD endpoints. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mg*day/dL||Standard Deviation|Mean
2611509|NCT02043301|Secondary|Time to Reach Maximum LDL-C Lowering (Tmax, LDL-C)|Time to LDL-C Emax|Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination|The PD analysis population included all enrolled participants who received at least 1 dose of study medication and had both baseline and post-baseline values for at least 1 of the PD endpoints.|||days||Full Range|Median
2611510|NCT02043301|Secondary|Emax: Percent Change From Baseline|LDL-C Emax expressed as percent change from baseline.|Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination|The PD analysis population included all enrolled participants who received at least 1 dose of study medication and had both baseline and post-baseline values for at least 1 of the PD endpoints.|||percent change||Standard Deviation|Mean
2611511|NCT02043301|Secondary|Emax: Change From Baseline|LDL-C Emax expressed as change from baseline.|Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination|The PD analysis population included all enrolled participants who received at least 1 dose of study medication and had both baseline and post-baseline values for at least 1 of the PD endpoints.|||mg/dL||Standard Deviation|Mean
2611512|NCT02043301|Secondary|Maximum Low-density Lipoprotein Cholesterol LDL-C Lowering Effect (Emax): Absolute Value|Maximum LDL-C response using absolute on trial LDL-C data|Baseline (average of Day -7 and Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination|The pharmacodynamic (PD) analysis population included all enrolled participants who received at least 1 dose of study medication and had both baseline and post-baseline values for at least 1 of the PD endpoints.|||mg/dL||Standard Deviation|Mean
2611513|NCT02043301|Secondary|Terminal Elimination Half-Life (t1/2)|Terminal elimination half-life following subcutaneous administration.|Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.|The PK parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||days||Standard Deviation|Mean
2611514|NCT02043301|Secondary|Apparent Volume of Distribution (Vz/F)|Apparent volume of distribution following subcutaneous administration.|Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.|The PK parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||liters||Geometric Coefficient of Variation|Geometric Mean
2611515|NCT02043301|Secondary|Apparent Clearance (CL/F)|Apparent clearance following subcutaneous administration.|Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.|The PK parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||liters per day||Geometric Coefficient of Variation|Geometric Mean
2611516|NCT02043301|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Time for maximum observed concentration.|Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.|The PK parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest.|||days||Full Range|Median
2611517|NCT02043301|Secondary|Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast)|AUClast is area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.|Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.|The PK parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest.|||mcg*day/mL||Geometric Coefficient of Variation|Geometric Mean
2611518|NCT02043301|Primary|Maximum Observed Plasma Concentration (Cmax)|Maximum observed concentration.|Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.|The PK parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2611519|NCT02043301|Primary|Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf)|AUCinf is the area under the plasma concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time.|Day 1 (Hour 0 pre-dose, Hours 1 and 8 post-dose), Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Day 50, Day 57, Day 64, Day 71 and Day 85/Early Termination.|The pharmacokinetic (PK) parameter analysis population included all enrolled participants who received at least 1 dose of study medication and that had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||micrograms*day/milliliter (mcg*day/mL)||Geometric Coefficient of Variation|Geometric Mean
2611520|NCT02043197|Other Pre-specified|Percent of Patients With Change in Clinical Global Impression Scale - Global Improvement Subscale Assessed at Day 180|Global improvement - qualitative scale 0 = Not assessed, 1 = Very much improved , 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse|From Day 90 up to 180 days|The actual number of assessed patients was provided to each measure.|||percentage of participants|||Number
2611521|NCT02043197|Other Pre-specified|Change in the Clinical Condition Measured by Clinical Global Impression Scale - Severity of Illness Subscale From Day 90 to 180 Days|Clinical Global Impression Scale (CGI) was used. CGI is in the public domain. Severity of illness is the subscale of Clinical Global Impression (CGI). Severity of illness - reported in this place 0 = Not assessed, 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Among the most extremely ill patients|From Day 90 up to Up to 180 days|The actual number of assessed patients was provided to each measure.|||units on a scale||Standard Deviation|Mean
2611522|NCT02043197|Other Pre-specified|Percent of Patients With Quality of Sleep Change Assessed by Insomnia Severity Index (ISI) at Day 90|Percent of Patients With Quality of Sleep Change Assessed by Insomnia Severity Index (ISI) From Baseline to Day 90.|From baseline up to Day 90|The actual number of assessed patients was provided to each measure.|||percentage of participants|||Number
2611523|NCT02043197|Other Pre-specified|Insomnia Severity Index|"Insomnia Severity Index (ISI) used under license agreement cmorin@psy.ulaval.ca~Total score has the range from 0 to 28 points with the following categories:~0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe). Higher values represent a worse outcome"|Baseline, Day 90, Up to 180 days|The actual number of assessed patients was provided to each measure.|||units on a scale||Standard Deviation|Mean
2611524|NCT02043197|Other Pre-specified|Cognitive Functions Measured by Montreal Cognitive Assessment (MOCA)|"MoCA test used under license agreement www.mocatest.org~Scale range 0-30 Normal >=26 Higher values represent a better outcome"|Baseline, Day 90, Up to 180 days|The actual number of assessed patients was provided to each measure.|||units on a scale||Standard Deviation|Mean
2611525|NCT02043197|Secondary|Employment||Baseline||||percentage of participants|||Number
2611526|NCT02043197|Secondary|Education||Baseline||||percentage of participants|||Number
2611527|NCT02043197|Secondary|Family Status||Baseline||||percentage of participants|||Number
2611528|NCT02043197|Secondary|Race||Baseline||||percentage of participants|||Number
2611529|NCT02043197|Secondary|Gender||Baseline||||percentage of participants|||Number
2611530|NCT02043197|Secondary|Percent of Patients With Change of Anxiety Symptoms From Baseline to Day 30.||From Baseline up to Day 30|The actual number of assessed patients was provided to each measure.|||percentage of participants|||Number
2611531|NCT02043197|Secondary|Anxiety and Depression Symptoms Score Measured by Hospital Anxiety and Depression Scale (HADS)|"HADS scale used under license agreement https://www.gl-assessment.co.uk/products/hospital-anxiety-and-depression-scale-hads/~The scale have two subscales:~HADS-Anxiety HADS-Depression~Each subscale has range 0-21 with following interpretation:~0-7 normal 8-10 mild 11-14 moderate 15-21 severe~In this place Change in the Hospital Anxiety and Depression Scale (HADS) Both Subscale Scores are presented assessed at Day 180"|Up to 180 days|The actual number of assessed patients was provided to each measure.|||units on a scale||Standard Deviation|Mean
2611532|NCT02043197|Secondary|Percent of Patients With Change in Clinical Global Impression Scale||From Baseline up to Day 90|The actual number of assessed patients was provided to each measure.|||percentage of participants|||Number
2611533|NCT02043197|Secondary|Change in the Clinical Condition Measured by Clinical Global Impression Scale - Severity of Illness Subscale|Clinical Global Impression Scale (CGI) was used. CGI is in the public domain. Severity of illness is the subscale of Clinical Global Impression (CGI). Severity of illness - reported in this place 0 = Not assessed, 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Among the most extremely ill patients|Baseline, Day 90|The actual number of assessed patients was provided to each measure.|||units on a scale||Standard Deviation|Mean
2611534|NCT02043197|Secondary|Change in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score|"HADS scale used under license agreement https://www.gl-assessment.co.uk/products/hospital-anxiety-and-depression-scale-hads/~The scale have two subscales:~HADS-Anxiety HADS-Depression~Each subscale has range 0-21 with following interpretation:~0-7 normal 8-10 mild 11-14 moderate 15-21 severe~In this place 'Change in the Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score' is presented"|From Baseline up to Day 30 and Day 90|The actual number of assessed patients was provided to each measure.|||units on a scale||Standard Deviation|Mean
2611535|NCT02043197|Secondary|Percent of Patients With Change of Depression Symptoms From Baseline to Day 30||From Baseline up to Day 30|The actual number of assessed patients was provided to each measure.|||percentage of participants|||Number
2611536|NCT02043197|Secondary|Change in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score|"HADS scale used under license agreement https://www.gl-assessment.co.uk/products/hospital-anxiety-and-depression-scale-hads/~The scale have two subscales:~HADS-Anxiety HADS-Depression~Each subscale has range 0-21 with following interpretation:~0-7 normal 8-10 mild 11-14 moderate 15-21 severe~In this place 'Change in the Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score' is presented"|From Baseline up to Day 30 and Day 90|The actual number of assessed patients was provided to each measure.|||units on a scale||Standard Deviation|Mean
2611537|NCT02043197|Primary|Prevalence of Different Neurological Disorders Associated With Depression Treated With Fluvoxamine (Fevarin®).|The primary neurologic diagnosis was coded according to International Classification of Diseases and Related Health Problems, revision 10 http://apps.who.int/classifications/icd10/browse/2010/en In the report all diseases were summarized by Classes. Percentage of patients reporting at least once a specified symptom during the treatment period.|Baseline|The actual number of assessed patients was provided to each measure.|||Percentage||95% Confidence Interval|Number
2611538|NCT02043145|Primary|Change From Baseline in the Investigator Assessment of Glabellar Line Severity Using a 4-point Scale|The Investigator assessed the severity of the patient's glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate or 3=severe. A negative change from Baseline indicated improvement.|Pre-dose (Baseline), Post-dose (Up to 4 Years)|Efficacy population included all participants who were treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®), who violated dose/administration or who were missing data were excluded.|||score on a scale||Standard Deviation|Mean
2611539|NCT02043145|Primary|Change From Baseline in the Modified Ashworth Scale (MAS) Using a 6-Point Scale|The MAS assessed the degree of muscle tone during movement of the upper limbs compared to normal muscle tone using a 6-point scale at where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). A negative change from Baseline indicated improvement.|Pre-dose (Baseline), Post-dose (Up to 4 Years)|Efficacy population included all participants who were treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®), who violated dose/administration or who were missing data were excluded.|||score on a scale||Standard Deviation|Mean
2611540|NCT02043145|Primary|Change From Baseline in the Hyperhidrosis Disease Severity Scale (HDSS) Using a 4-Point Scale|Participants assessed their underarm sweat using the 4-point HDSS where: 1=Never noticeable and never interferes with my daily activities, 2=Tolerable but sometimes interferes with my daily activities, 3=Barely tolerable and frequently interferes with my daily activities or 4=Intolerable and always interferes with my daily activities. A negative change from Baseline indicated improvement.|Pre-dose (Baseline), Post-dose (Up to 4 Years)|Efficacy population included all participants who were treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®), who violated dose/administration or who were missing data were excluded.|||score on a scale||Standard Deviation|Mean
2611541|NCT02043145|Primary|Number of Patients With Adverse Events (AEs) and Serious Adverse Drug Reactions (SADRs)|An AE was defined as any undesirable changes in medical findings (including laboratory test findings) identified during medical examinations as well as AEs associated with the study drug application that occurred during or after administration of the study drug, regardless of causal relationship to the study drug. A SADR was any drug reaction that: resulted in death or was life threatening, required hospitalization or prolonged hospitalization, caused persistent or significant disability/incapacity, caused a congenital anomaly/birth defect or other medically important event.|4 Years|Safety population included all participants treated with BOTOX® as prescribed. Participants previously treated with survey drug (BOTOX®) were excluded.|||participants|||Number
2611542|NCT02043132|Secondary|Number of Participants Experiencing Infection as a Surgical Site Complication|"The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.~Infection"|up to 6-weeks post-operatively||||Participants|||Count of Participants
2611543|NCT02043132|Secondary|Number of Participants Experiencing Hematoma as a Surgical Site Complication|"The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.~Hematoma"|up to 6-weeks post-operatively||||Participants|||Count of Participants
2611563|NCT02042924|Primary|Percentage of Proliferating Bone Marrow in the Femur|The difference in the percentage of proliferating bone marrow between baseline and day 100 post transplant in the femur|100 days|Only one patient was enrolled in each cohort and therefore any analysis would not be meaningful.||||||
2611544|NCT02043132|Secondary|Number of Participants Experiencing Deep Vein Thrombosis|"The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.~Deep venous thrombosis"|up to 6-weeks post-operatively||||Participants|||Count of Participants
2611545|NCT02043132|Secondary|Number of Participants Experiencing Myocardial Infarction|"The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.~Myocardial infarction"|up to 6-weeks post-operatively||||Participants|||Count of Participants
2611546|NCT02043132|Secondary|Number of Participants Experiencing Pulmonary Embolism|"The occurrence of the following systemic and surgical site complications within 6 weeks of surgery will be recorded. Data will be obtained from EMR and from patient at standard of care 2 week and 6 week follow-up appointment.~Pulmonary Embolism"|up to 6-weeks post-operatively||||Participants|||Count of Participants
2611547|NCT02043132|Primary|Total Drain Output|Total Drain Output as measured postoperatively 0-48 hours|0-48 hours postoperatively||||mL||95% Confidence Interval|Mean
2611548|NCT02043132|Primary|Total Hemoglobin Loss|Total hemoglobin loss estimated using the formula for total blood volume described by Nadler et al Hb(loss) = blood volume (L) x [Hb(initial)(g/L) - Hb(final)(g/L)] + Hb(transfused)|Preoperative through Postoperative Days 1 and 2||||g||95% Confidence Interval|Mean
2611549|NCT02043132|Primary|Total Blood Loss|Total Blood Loss as calculated according to method as described by Good et al. Total Blood Loss (mL) = 1000 X Hb(loss)/Hb(initial)|Preoperative through Postoperative Days 1 and 2||||Total Blood Loss (mL)||Standard Deviation|Mean
2611550|NCT02043015|Secondary|Acceptability of Provider Training|Measured as the number of providers who accept the training related to MSM-specific healthcare.|12 months|The mandatory MSM-specific training had already been completed for health care providers in Cape Town, thus the training specified by the study protocol was no longer necessary.||||||
2611551|NCT02043015|Secondary|Acceptability of Post-exposure Prophylaxis (PEP)|Measured as the number of men who report an eligible exposure who accept and initiate PEP.|12 months|Participants who tested HIV-negative at baseline and were followed prospectively.|||Participants|||Count of Participants
2611552|NCT02043015|Secondary|Serodiscordant Unprotected Anal Intercourse (UAI)|Measured as any self-reported unprotected anal intercourse in the last three or six months with a partner of opposite or unknown HIV status, as self-reported in the questionnaire at each study visit.|Month 3, 6, and 12|The analysis population includes all prospectively followed participants who completed the survey.|||Participants|||Count of Participants
2611553|NCT02043015|Secondary|Number of HIV Tests During Study|The number of HIV tests per participant administered during the study period.|12 months|This analysis includes all participants enrolled for prospective follow-up at baseline.|||HIV tests||Standard Deviation|Mean
2611554|NCT02043015|Secondary|Voluntary Counseling and Testing (VCT) and Couples Voluntary Counseling and Testing (CVCT) Uptake|VCT and CVCT is measured as the number and percentage of participants who completed VCT in the study period as part of the study visits and the number and percentage of participants who self-reported VCT outside of their study visits. These are compared to the number and percentage of participants who self-reported having VCT in the year prior at baseline. CVCT is measured as the number and percentage of participants who completed a CVCT session as part of the study.|12 months|Participants who tested HIV-negative at baseline and were enrolled for prospective follow-up.|||Participants|||Count of Participants
2611555|NCT02043015|Secondary|Lubricant Use|Measured as the number and percentage of participants who used condom-compatible lubricant during their most recent anal sex act, among those who also used a condom at their most recent anal sex act.|Months 3, 6, and 12|This analysis includes all participants enrolled for prospective follow-up at baseline who self-reported using a condom during their most recent anal sex reported.|||Participants|||Count of Participants
2611556|NCT02043015|Secondary|Condom Use|Condom use is measured as the number of male anal sex partners that the study participant always used condoms with in the prior three or six months, as self-reported reported in the questionnaire at each study visit.|Months 3, 6, and 12|This analysis includes all participants enrolled for prospective follow-up at baseline.|||Sex partners|Sex partners||Count of Units
2611557|NCT02043015|Primary|Number of Participants With New HIV Infection|Incident HIV infection is measured as the number of seroconversions during follow-up among those who are HIV-uninfected at baseline.|12 months|The population includes all participants who were HIV-negative at baseline.|||Participants|||Count of Participants
2611558|NCT02043015|Primary|Use of PrEP|Uptake of PrEP by study participants was measured as the number and percentage of enrolled participants eligible for PrEP at the baseline and 3-month study visits who choose to initiate PrEP at a visit one month later.|4 months|Of the 80 participants who were HIV-negative at the baseline visit, 60 were PrEP-eligible based on behavioral and clinical criteria. At the Month 3 visit, participants who were not already on PrEP could be assessed for PrEP eligibility again. Participants could be counted as PrEP-eligible at both the Baseline and Month 3 time points.|||Participants|||Count of Participants
2611559|NCT02043015|Primary|Retention in the Cohort|The ability of the study to retain participants for full study period was assessed. Retention was measured by the number and percentage of enrolled participants attending study visits through the 12-month study period.|12 months|This analysis includes all participants enrolled for prospective follow-up at baseline. Twenty of the participants tested HIV-positive at baseline, and the remaining 80 tested HIV-negative.|||Participants|||Count of Participants
2611560|NCT02042950|Other Pre-specified|Post Treatment|To estimate the response duration, progression free survival, time to failure and overall survival.|21 months|Unable to complete final analysis due to not meeting enrollment requirements.||||||
2611561|NCT02042950|Other Pre-specified|Toxicity of Carfilzomib|To further evaluate the toxicity of Carfilzomib in patients|21 months|Unable to complete final analysis due to not meeting enrollment requirements.||||||
2611562|NCT02042950|Primary|Overall Response Rate of Carfilzomib|To evaluate the efficacy of single agent carfilzomib in patients with relapsed/refractory MCL as measured by response rate.|21 months|Unable to complete final analysis due to not meeting enrollment requirements.||||||
2611565|NCT02042924|Primary|Difference in Percentage of Proliferating Bone Marrow Between Baseline and 100 Days|The difference in percentage of proliferating bone marrow will be calculated for the following sites: skull, proximal humeri, ribs, clavicles, cervical spine, thoracic spine, lumbar spine, sacrum, pelvis and proximal femur.|100 days|Only one patient was enrolled in each cohort and therefore any analysis would not be meaningful.||||||
2611566|NCT02042911|Secondary|Number of Subjects With Clinically Significant Physical Examination Values|Number of subjects with abnormal or severe values of vital signs, electrocardiogram, and physical examination including ECOG performance status|Up to 30 months||||participants|||Number
2611567|NCT02042911|Secondary|Number of Subjects With Clinically Significant Laboratory Test Values of Grade 3 or More|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild grade 2 : moderate grade 3 : severe or medically significant but not immediately life-threatening grade 4 : life threatening or disabling grade 5 : death related to adverse event|Up to 30 months||||participants|||Number
2611568|NCT02042911|Secondary|Adverse Events|All undesirable medical events experienced by the subject treated with the investigational product (including abnormal changes in laboratory values) are treated as adverse events and evaluated for safety.|Up to 30 months||||participants|||Number
2611569|NCT02042911|Secondary|Overall Survival (OS)|The period from the date of patient registration to the date of death.|Up to 30 months||||months||95% Confidence Interval|Median
2611570|NCT02042911|Secondary|Duration of Remission|The period from the day of CR or PR confirmation to recurrence/relapse.|Up to 30 months||||months||95% Confidence Interval|Median
2611571|NCT02042911|Secondary|Progression-free Survival (PFS)|The period from the first day of the study drug administration (Day1) to progressive disease (PD), recurrence/relapse, or death.|Up to 30 months||||months||95% Confidence Interval|Median
2611572|NCT02042911|Secondary|Complete Remission Rate (CR+CRi) Based on IWCLL Guideline||Up to 30 months||||Percentage of participants||95% Confidence Interval|Number
2611573|NCT02042911|Secondary|National Cancer Institute-sponsored Working Group (NCI-WG) Response Rate (CR+nPR+PR) Based on IWCLL Guideline|"The criteria for nPR and PR based on IWCLL guideline are shown below.~nPR: Fulfills all CR criteria other than residual lymphoid nodules confirmed by bone marrow examination.~PR: Fulfills two or more items from Group A and one or more items from Group B for a minimal duration of 8 weeks.~Group A;~50% or greater reduction in lymphocyte count in peripheral blood from baseline~50% or greater reduction (size reduction) in Sum of the products of the greatest diameters (SPD) and no new lesion emergence or no new enlarged lymph node~A decrease in the size of the liver and/or spleen by 50% more~A decrease in marrow infiltration or lymphoid nodules by 50% more Group B;~1) Neutrophil count ＞1.5×10^9/L or 50% improvement from baseline 2) Platelet count ＞100×10^9/L or 50% improvement from baseline 3) Hemoglobin 11.0 g/dL or 50% improvement from baseline without transfusions"|Up to 30 months||||Percentage of participants||95% Confidence Interval|Number
2611574|NCT02042911|Primary|Response Rate [Complete Remission (CR) +Complete Remission / Incomplete (CRi) + Nodular Partial Remission (nPR) + Partial Remission (PR)] Based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Guideline|"The criteria for CR, CRi, nPR and PR based on IWCLL guideline are shown below. For the criteria for nPR and PR, please refer to the description of NCI-WG response rate (CR+nPR+PR).~CR: Assessment should be made at least 8 weeks after completion of administration.~Absence of significant lymphadenopathy (lymph nodes greater than 1.5 cm in diameter)~No hepatomegaly or splenomegaly~Absence of B symptoms~Meet the following laboratory test values;~lymphocyte count in peripheral blood: ＜4.0×10^9/L~neutrophil count: ＞1.5×10^9/L~platelet count: 100×10^9/L~hemoglobin: 11.0 g/dL without transfusions~less than 30% of nucleated cells are lymphocytes (confirmed by bone marrow aspiration and no lymphoid nodules).~No new lesion emergence~CRi: Fulfills all of the following criteria~Delayed anemia, thrombocytopenia, or neutropenia is observed.~Fulfills all CR criteria other than 4).~Delayed symptoms are all judged to be caused by drug."|Up to 30 months||||Percentage of participants||95% Confidence Interval|Number
2611575|NCT02042872|Secondary|Bone Mineral Density (BMD) at the Total Hip at Baseline and Month 12|An imaging method known as dual energy x-ray absorptiometry (DXA) was used to obtain BMD of the total hip.|Baseline and 12 months||||g/cm2||Standard Deviation|Mean
2611576|NCT02042872|Primary|Bone Mineral Density (BMD) at the Distal Femur and Proximal Tibia at Baseline and Month 12.|An imaging method known as dual energy x-ray absorptiometry (DXA) was used to obtain BMD of the distal femur and proximal tibia by using a customized research software program supplied by the manufacturer. This measurement will be the primary determinant (dependent measure) of difference among the treatment and control groups, and they will be followed over time at the previously specified time points.|Baseline and 12 months||||g/cm2||Standard Deviation|Mean
2611577|NCT02042534|Secondary|Number of Participants With Modified Rankin Score of 0 or 1 at Week 4|"modified Rankin Score~0 : No symptoms at all~: No significant disability despite symptoms; able to carry out all usual duties and activities~: Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance~: Moderate disability; requiring some help, but able to walk without assistance~: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance~: Severe disability; bedridden, incontinent and requiring constant nursing care and attention~: Dead"|at 1 month|Modified ITT (mRS 0,1 at Week 4, n(%)|||participants|||Number
2611578|NCT02042534|Secondary|Length of Hospitalization|Time to event will be calculated|at 1month||||days||Standard Deviation|Mean
2611579|NCT02042534|Secondary|The Number of Patients With Recurrent Ischemic Lesion|Recurrent ischemic lesion confirmed by relevant neuroimagings|at 1 month|Modified ITT|||Participants|||Number
2611580|NCT02042534|Secondary|The Number of Patients With Intracranial Bleeding|Intracranial bleeding confirmed by relevant neuroimagings|at 1 month|Modified ITT|||Participants|||Number
2611581|NCT02042534|Primary|Number of Participants With Intracranial Bleeding and/or Recurrent Ischemic Lesion as Confirmed by MRI Imaging|"Intracranial bleeding: symptomatic hemorrhage confirmed by CT or MRI or asymptomatic hemorrhage on follow-up GRE or SWI imaging at 1 month~Recurrent ischemic lesion: symptomatic ischemic stroke confirmed by relevant neuroimagings or asymptomatic recurrent ischemic lesion on follow-up or FLAIR imaging at 1 month"|1 month after randomization|"modified Intention to treat: 95 / 88 (Rivaroxaban/Warfarin)~Per protocol: 93 / 87 (Rivaroxaban/Warfarin)~Safety: 98 / 90 (Rivaroxaban/Warfarin)"|||Participants|||Number
2611582|NCT02042443|Secondary|Progression-free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients.|||months||95% Confidence Interval|Median
2611583|NCT02042443|Secondary|Objective Response Rate|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 2 years from registration|All eligible and analyzable patients with measurable disease.|||Participants|||Count of Participants
2611584|NCT02042443|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse event reporting followed the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 2 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary. One patient was hospitalized prior to receiving protocol treatment and was not assessed for adverse events.|||Participants|||Count of Participants
2611585|NCT02042443|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years from registration|Eligible and analyzable patients.|||months||95% Confidence Interval|Median
2611586|NCT02042404|Other Pre-specified|Determine the Incidence of Serious Device- and Procedure-related Adverse Events.|The analysis of the incidence of serious device- and procedure-related adverse events through the study period. All adverse events will be recorded on case report forms and determinations will be made as to the whether the events are related to the investigational device.|120 days|Both Primary Cohort and Roll-in Cohort were included in all safety analyses.|||serious device- or procedure-related AEs|||Number
2611587|NCT02042404|Secondary|Change in Aided HINT 90 Speech Reception Thresholds (SRTs) When Compared to the Baseline Unaided Condition.|Change in aided HINT 90 speech reception thresholds (SRTs) when compared to the baseline unaided condition. SRTs will be measured using HINT materials with the signal (speech level presented from 0 degrees) adapted relative to the noise (presented from 90 degrees held fixed at 60 dB SPL) to determine the signal-to-noise ratio for reporting the whole sentence correct 50% of the time (Nilsson et al., 1994). An improvement in HINT score is indicated as a negative (-) dB value change. A more negative value indicating an improvement of understanding speech and noise. An improvement of -1dB is equivalent to a 10% improvement in understanding speech and noise and is likely of clinical benefit. HINT 90 will be measured twice and averaged to obtain the per subject HINT SRT. All subject data will be averaged to obtain the means. Analysis includes calculation of the unaided measurements (before device placement) minus the aided measurements.|Baseline and 30 days|39 subjects available for analysis between enrollment/treatment and 30 day measurement.|||dB difference in HINT scores||Standard Deviation|Mean
2611588|NCT02042404|Secondary|Functional Gain Over the Frequency Range From 2000 to 10,000 Hz|10 dB (decibel) change in the averaged pure tone thresholds for the subject population over the frequency range from 2000 to 10,000 Hz (2000, 3000, 4000, 6000, 8000, 9000 and 10,000 Hz). Measurement to be used in analysis are the baseline unaided soundfield thresholds measured prior to device placement and the aided soundfield thresholds measured at least 30 days post placement. Analysis includes calculation of the unaided soundfield thresholds minus aided soundfield thresholds.|Baseline and 30 days|39 subjects available for analysis between enrollment/treatment and 30 day measurement.|||dB difference in Soundfield Hearing||Standard Deviation|Mean
2611589|NCT02042404|Primary|Audiometric Safety as Shown by no Hearing Change Pre and Post Treatment|"The unaided air conduction hearing thresholds will be measured for each individual ear twice before device placement at Visit #1 and averaged to obtain the baseline unaided air conduction hearing thresholds, and the post wear unaided air conduction hearing thresholds will be measured after device removal at Visit #5. A PTA4 (Pure Tone Average at 4 frequencies; 500, 1000, 2000, and 4000 Hz) will be computed both for baseline unaided hearing pre-placement and unaided hearing post-removal for each ear, then averaged across both ears for each subject . A determination of No Hearing Change for the subject population will be made if the calculated Hearing Changes of the subject population are 10 dB or less."|Baseline and 120 days|43 subjects available for analysis between enrollment/treatment and 120 day measurement.|||dB difference in Unaided Hearing||Standard Deviation|Mean
2611590|NCT02042404|Primary|Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition.|Change in mean aided Word Recognition Scores (WRS) when compared to the baseline unaided condition. WRS will be measured using 50-word NU-6 (Northwestern University Auditory Test No.6) recorded materials, presented at 45 dB Hearing Level on a per-ear basis with the test ear isolated for measurement and the results, expressed as a percentage of words correct, averaged across the two ears for each subject. All subject data will then be averaged to obtain the means. The baseline unaided measurements will occur prior to device placement, and the aided condition will be measured at least 30 days post device placement.|Baseline and 30 days|39 subjects available for analysis between enrollment/treatment and 30 day measurement.|||percentage of words correctly identified||Standard Deviation|Mean
2611591|NCT02042274|Secondary|Blood Glucose|Blood glucose levels measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.|Baseline, 3 months, 5 months||||mmol/L||Standard Deviation|Mean
2611592|NCT02042274|Primary|Blood Triglyceride|Blood triglycerides were measured at distinct time points: baseline, after 3 months supplementation, and after a 2 month wash out period.|Baseline, 3 months, 5 months|Healthy adults, ranging in age from 18-65 years.|||mmol/L||Standard Deviation|Mean
2611593|NCT02042131|Other Pre-specified|Number of Participants Who Were Admitted for Psychiatric Hospitalization Immediately Post-intervention by a Blinded Clinician|Doctoral-level clinicians (i.e., physicians or psychologists) who were blind to treatment condition made a determination regarding psychiatric inpatient admission (either admit or not admit) immediately following the intervention.|Immediately post-intervention||||Participants|||Count of Participants
2611594|NCT02042131|Secondary|Inpatient Psychiatric Hospitalization Days|Mean number of days of inpatient psychiatric hospitalization|6 months||||days||Standard Error|Mean
2611595|NCT02042131|Secondary|Beck Scale for Suicide Ideation (BSSI)|The BSSI is used to evaluate the intensity of the patient's specific attitudes, behaviors, and plans to make a suicide attempt. BSSI total score was used as the outcome measure. Total scores range from 0 to 38, with higher scores indicating more severe suicide ideation.|1 month, 3 months, and 6 months||||units on a scale||Standard Error|Mean
2611596|NCT02042131|Primary|Estimated Proportion of Participants With Suicide Attempt|Suicide attempts were assessed using the Suicide Attempt Self Injury Interview (SASII; Linehan et al., 2006). The SASII is a valid and reliable clinician-administered interview for categorizing suicide-related and self-injurious behaviors. Suicide attempt was defined as behavior that is self-directed and deliberately results in injury or the potential for injury to oneself for which there is evidence, whether implicit or explicit, of suicidal intent|6 months|all participants enrolled, regardless of dropout or withdrawal|||estimated proportion of participants|||Number
2611597|NCT02042014|Primary|Serious Adverse Events|All Serious Adverse Events were evaluated and reported for all participants receiving QTI571. 16 individual SAEs were observed in 5 subjects.|Approximately 2.9 years||||participants|||Number
2611598|NCT02041962|Primary|Mood Disorder Symptoms, as Measured by the Patient Health Questionnaire (9-question)|Mood disorder symptoms were measured using the Patient Health Questionnaire (9-question). The PHQ-9 has a scale range of 0-27 with lower values representing better outcomes.|12-months||||score on a scale||Standard Deviation|Mean
2611599|NCT02041962|Primary|Health-related Quality of Life, as Measured by the Mental Health Component Score|Mental Health Quality of Life was measured using the 12-item Short Form Survey (SF-12). The SF-12 has a scale range of 0-100 with higher values representing better outcomes.|12-months||||score on a scale||Standard Deviation|Mean
2611600|NCT02041702|Primary|Change in RV Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan|Number of subjects who experienced a decrease in RV sensing amplitude ≤ 50% and at least 5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit|MRI Visit, 1 Month Post MRI Visit|Subject successfully implanted, randomized, completed MRI and 1-month post MRI visit, had pre-MRI sensing amplitude ≥ 5 millivolt (mV) in RV &1.5 mV in RA and had an intrinsic rate ≥ 30 beat per minute (bpm) at the time of ventricular sensing amplitude measurement, received an MRI scan if he was in MRI scan group and fulfilled MRI Conditions of Use|||Participants|||Count of Participants
2611601|NCT02041702|Primary|Change in RA Sensing Amplitude From Pre-MRI Scan to 1 Month After MRI Scan|Number of subjects who experienced a decrease in RA sensing amplitude ≤ 50% and at least 1.5 mV at 1-Month post MRI scan visit compared to pre-MRI scan value collected at MRI scan visit|MRI Visit, 1 Month Post MRI Visit|Subject successfully implanted, randomized, completed MRI and 1-month post MRI visit, had pre-MRI sensing amplitude ≥ 5 millivolt (mV) in RV &1.5 mV in RA and had an intrinsic rate ≥ 30 beat per minute (bpm) at the time of ventricular sensing amplitude measurement, received an MRI scan if he was in MRI scan group and fulfilled MRI Conditions of Use|||Participants|||Count of Participants
2611602|NCT02041702|Primary|Change in Right Ventricular (RV) Capture Threshold @0.5ms From Pre-MRI Scan to 1 Month After MRI Scan|Number of subjects who experienced an increase in RV capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 V compared to pre-MRI scan value collected at MRI scan visit|MRI Visit, 1 Month Post MRI Visit|Subject successfully implanted, randomized, completed MRI and 1-month post MRI visit, had pre-MRI sensing amplitude ≥ 5 millivolt (mV) in RV &1.5 mV in RA and had an intrinsic rate ≥ 30 beat per minute (bpm) at the time of ventricular sensing amplitude measurement, received an MRI scan if he was in MRI scan group and fulfilled MRI Conditions of Use|||Participants|||Count of Participants
2611603|NCT02041702|Primary|Change in Right Atrial (RA) Capture Threshold @0.5 Millisecond (ms) From Pre-MRI Scan to 1 Month After MRI Scan|Number of subjects who experienced an increase in RA capture threshold @ 0.5 ms at 1-Month post MRI scan visit ≤ 0.5 Volt (V) compared to pre-MRI scan value collected at MRI scan visit|MRI Visit ,1 Month Post MRI Visit|Subject successfully implanted, randomized, completed MRI and 1-month post MRI visit, had pre-MRI sensing amplitude ≥ 5 millivolt (mV) in RV &1.5 mV in RA and had an intrinsic rate ≥ 30 beat per minute (bpm) at the time of ventricular sensing amplitude measurement, received an MRI scan if he was in MRI scan group and fulfilled MRI Conditions of Use|||Participants|||Count of Participants
2611604|NCT02041702|Primary|Freedom From MRI Scan-related Complications|Number of subjects who were free from MRI scan-related complications|MRI Visit ,1 Month Post MRI Visit|All subjects in Cardiac MRI Scan group who underwent an elective non-diagnostic cardiac MRI scan and completed all protocol specific visits were included in the analysis. Subjects who withdrew from the study before 1 month post MRI visit and had no MRI scan related complications were excluded.|||Participants|||Count of Participants
2611605|NCT02041533|Secondary|Disease-related Symptom Improvement Rate by Week 12|The Lung Cancer Symptom Score (LCSS) is a validated instrument designed to assess the impact of treatment on disease-related symptoms. It consists of 6 symptom-specific questions related to dyspnea, cough, fatigue, pain, hemoptysis and anorexia plus 3 summary items: symptom distress, interference with activity, and global HRQoL. The degree of impairment was recorded on a 100 mm visual analogue scale with scores from 0 to 100 with zero representing the best score. Disease-related symptom improvement rate by Week 12 is defined as the proportion of all randomized (all PD-L1+) participants who had 10 points or more decrease from baseline in average symptom burden index score at any time between randomization and Week 12.|From date of randomization to week 12|All randomized participants|||Percentage of participants||95% Confidence Interval|Number
2611606|NCT02041533|Secondary|Time to Response in Participants With PD-L1 Expression >= 5%|Time to Response (TTR) was defined as the time from randomization to the date of the first response (CR or PR), as assessed by IRRC assessment. TTR was evaluated for responders only. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.|From date of randomization to date of first confirmed response (assessed up to August 2016, approximately 18 months)|All randomized participants with a confirmed response and PD-L1 expression >= 5%|||months||Full Range|Median
2611620|NCT02041520|Primary|Change on Malondialdehyde After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value||||nM/mg protein||95% Confidence Interval|Mean
2611607|NCT02041533|Secondary|Duration of Response in Participants With PD-L1 Expression>= 5%|Duration of Response (DOR) was summarized for participants with objective response and was defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression as determined by IRRC assessment (per RECIST v1.1) or death due to any cause, whichever occurs first. DOR censoring rules were the same as the PFS primary definition. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir|From date of first confirmed response to date of tumor progression (Assessed up to August 2016, approximately 28 months)|All randomized participants with a confirmed response and PD-L1 expression >= 5%|||months||Full Range|Median
2611608|NCT02041533|Secondary|Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%|ORR was defined as the proportion of randomized participants who achieved a Best Overall Response (BOR) of CR or PR using the RECIST v1.1 criteria per Independent Radiology Review Committee (IRRC) assessment. BOR was defined as the best response designation recorded between the date of randomization and the date of objectively documented progression or start of subsequent anti-cancer therapy, whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. For participants who continued treatment beyond progression, BOR was determined from response designations recorded up to the time of initial progression. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.|From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months)|All randomized participants with PD-L1 expression >= 5%|||Percentage of participants||95% Confidence Interval|Number
2611609|NCT02041533|Secondary|Overall Survival in All Randomized Participants|Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.|From date of randomization to date of death (assessed up to August 2016, approximately 28 months)|All randomized participants|||months||95% Confidence Interval|Median
2611610|NCT02041533|Secondary|Overall Survival in Participants With PD-L1 Expression >= 5%|Overall Survival (OS) was defined as the time from randomization to the date of death. A participant who had not died was censored at the last known alive date. OS was censored at the date of randomization for participants who were randomized but had no follow-up.|From date of randomization to date of death (assessed up to August 2016, approximately 28 months)|All randomized participants with PD-L1 expression >= 5%|||months||95% Confidence Interval|Median
2611611|NCT02041533|Secondary|Progression-Free Survival in All Randomized Participants|Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.|From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)|All randomized participants|||months||95% Confidence Interval|Median
2611612|NCT02041533|Primary|Progression-Free Survival in Participants With PD-L1 Expression >= 5%|Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.|From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)|All randomized participants with PD-L1 expression levels >= 5%|||months||95% Confidence Interval|Median
2611613|NCT02041520|Secondary|Change on Aspartate Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value||||UI/L||95% Confidence Interval|Mean
2611614|NCT02041520|Secondary|Change on Alanine Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value||||UI/L||95% Confidence Interval|Mean
2611615|NCT02041520|Secondary|Change on Reduced- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value||||µM||95% Confidence Interval|Mean
2611616|NCT02041520|Secondary|Change on Oxidized- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value||||µM||95% Confidence Interval|Mean
2611617|NCT02041520|Secondary|Change on Viral Load After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value||||copies/ml||95% Confidence Interval|Mean
2611618|NCT02041520|Secondary|Change on Nitric Oxide After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value||||µM/ml||Standard Deviation|Mean
2611619|NCT02041520|Secondary|Change on Total Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients||The difference of this value at 6 months in relation to baseline value||||µM||95% Confidence Interval|Mean
2611621|NCT02041377|Secondary|Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements|Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond Strongly Agree; Agree; Neutral; Disagree; or Strongly Disagree.|1 hour||||participants|||Number
2611622|NCT02041377|Secondary|Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtained and tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|133 (134-1) Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol.|||Blood glucose results|||Number
2611623|NCT02041377|Secondary|Number of Blood Glucose (BG) Results From Alternative Site Testing (AST) Palm Blood Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Subjects with diabetes self-tested Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS AST palm results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|129 (134-5) Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol. One subject had low blood sugar and AST result was not evaluable per protocol. One subject with low blood sugar did not attempt AST testing per protocol. No AST palm results were obtained for 2 subjects.|||Blood glucose results|||Number
2611624|NCT02041377|Secondary|Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma).|1 hour|131 (134-3) Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol. Venipuncture was not successful for 2 subjects.|||Blood glucose results|||Number
2611625|NCT02041377|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|132 (134-2)Blood glucose results were analyzed. Lab reference replicates for one subject were discrepant and not evaluable per protocol. One subject had no fingerstick result.|||Blood glucose results|||Number
2611626|NCT02041325|Secondary|Phenotypic Changes|Phenotypic changes in peripheral blood cells following CC-5013 (lenalidomide) administration especially in regards to CD3, CD4, CD8 T cells, and NK and NKT cells.|6 weeks||||cells/cmm||Full Range|Median
2611627|NCT02041325|Secondary|Quantity of Subjects With a T-cell Response|Participants who displayed a T cell responses against HbSAg following vaccination|6 weeks||||participants|||Number
2611628|NCT02041325|Secondary|Safety|Number of participants with adverse events as a measure of safety and tolerability|6 weeks||||participants|||Number
2611629|NCT02041325|Primary|Positive for Hepatitis B Surface Antigen|The number of participants who test positive for the antibody titer against hepatitis B surface antigen (HbSAg).|6 weeks||||participants|||Number
2611630|NCT02041286|Secondary|Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements|Staff will obtain subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects may respond Strongly Agree; Agree; Neutral; Disagree; or Strongly Disagree.|1 hour||||participants|||Number
2611631|NCT02041286|Secondary|Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff|Study staff obtain and test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|135 (136-1) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia AE.|||Blood glucose results|||Number
2611632|NCT02041286|Secondary|Number of Blood Glucose (BG) Results From Alternative Site Testing (AST) Palm Blood Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Subjects with diabetes self-test Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS AST palm results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|130 (136-6) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia AE. One (1) subject with low blood sugar did not attempt AST testing per protocol. No AST palm results were obtained for one (1) subject. Three (3) subjects had low blood sugar; AST results were not evaluable per protocol.|||Blood glucose results|||Number
2611646|NCT02041104|Primary|Systolic and Diastolic Blood Pressure|Before the intervention, systolic and diastolic blood pressure were measured. Measurement was performed to obtain parameters for metabolic syndrome definition. Measurements after dietary intervention weren`t performed.|Outcome measurement at baseline.|Systolic and diastolic blood pressure were measured before dietary intervention in a population with metabolic syndrome or with high risk for metabolic syndrome development.|||mm Hg||Standard Deviation|Mean
2611633|NCT02041286|Secondary|Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Study staff test subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma).|1 hour|132 (136-4) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia AE. One (1) subject lab reference replicates were discrepant and not evaluable per protocol. Venipuncture was not successful for 2 subjects.|||Blood glucose results|||Number
2611634|NCT02041286|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method|Subjects with diabetes self-test fingerstick blood use an investigational Blood Glucose Monitoring System (BGMS) with no training. BGMS results are compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma).|1 hour|135 (136-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available.|||Blood glucose results|||Number
2611635|NCT02041221|Primary|Number of Subjects With Adverse Events|The no of adverse events will be assessed to evaluate the safety and tolerability of compound SO597 in healthy male subjects and asthma patients|Two (2) Weeks||||participants|||Number
2611636|NCT02041104|Secondary|Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations)|"Pharmacokinetic outcome measures: Determination of insulin resistance with OGTT testing. Before and after oral consumption of 75 g of glucose, plasma insulin concentration measurements were performed at following times:~0 min - before oral consumption of 75 g glucose 30 min, 60 min and 120 min - after oral consumption of 75 g glucose"|Outcome OGTT measurements performed after 4-week dietary intervention|In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed after dietary intervention.|||uM/mL||Standard Deviation|Mean
2611637|NCT02041104|Secondary|Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)|"Pharmacokinetic outcome measures: Determination of insulin resistance with OGTT testing. Before and after oral consumption of 75 g of glucose, plasma glucose concentration measurements were performed at following times:~0 min - before oral consumption of 75 g glucose 30 min, 60 min and 120 min - after oral consumption of 75 g glucose"|Outcome OGTT measurements performed after 4-week dietary intervention|In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed after dietary intervention.|||uM/mL||Standard Deviation|Mean
2611638|NCT02041104|Secondary|Total Cholesterol Levels|After the intervention, total cholesterol levels were determined.|Outcome measurement after 4-week dietary intervention|Total cholesterol levels were determined before diet intervention in both experimental groups.|||mmol/L||Standard Deviation|Mean
2611639|NCT02041104|Secondary|Triglyceride Levels|After the diet intervention, triglyceride levels were measured in test (consuming bread with added beta glucans) and in control group (consuming bread without added beta glucans).|Outcome measure after 4-week dietary intervention.|Triglyceride levels were measured in participants with metabolic syndrome or with high risk for metabolic syndrome development.|||mmol/L||Standard Deviation|Mean
2611640|NCT02041104|Secondary|HDL-cholesterol Levels|HDL-cholesterol levels were determined after diet intervention.|Outcome measurement after 4-week dietary intervention|HDL-cholesterol levels were determined after diet intervention in participants with metabolic syndrome or with high risk for metabolic syndrome development.|||mmol/L||Standard Deviation|Mean
2611641|NCT02041104|Secondary|LDL-cholesterol Levels|LDL-cholesterol levels were determined after intervention|Outcome measurement after 4-week dietary intervention|LDL-cholesterol levels were determined in both experimental groups.|||mmol/L||Standard Deviation|Mean
2611642|NCT02041104|Secondary|Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples|Fecal sampling for SCFA determination: Content of specific SCFA (butyric acid, acetic acid and propionic acid) will be determined in fecal samples using Gas Chromatography.|Outcome measurement after 4-week dietary intervention|We analyzed the concentration of short fatty acids from faeces from 41 participants belonging to test (bread with added beta-glucans) or control group (bread without added beta-glucans) after 4-week intervention period.|||g/kg||Standard Deviation|Mean
2611643|NCT02041104|Secondary|Determination of Composition of Intestinal Microbiota From Fecal Samples|Fecal sampling for microbiologic analysis of microbiota composition: Composition of intestinal microbiota will be determined with a combination of two molecular techniques denaturating gradient gel electrophoresis (DGGE) and quantitative real time PCR (RT-PCR).|Outcome measurement after 4-week dietary intervention|We analyzed faecal samples of 40 participants from the test and control group. Since DGGE method is only qualitative measurement, the only measurements of RT-PCR are shown. Results are presented as relative numbers of specific bacteria group ((number of specific bacteria group / all bacteria)*100).|||% of bacteria||Standard Deviation|Mean
2611644|NCT02041104|Primary|Triglyceride Levels|Before the diet intervention, triglyceride levels were measured in test (consuming bread with added beta glucans) and in control group (consuming bread without added beta glucans).|Outcome measure at baseline.|Triglyceride levels were measured in participants with metabolic syndrome or with high risk for metabolic syndrome development.|||mmol/L||Standard Deviation|Mean
2611645|NCT02041104|Primary|Determination of Concentration of Short Chain Fatty Acids (SCFA) Present in Fecal Samples|Fecal sampling for SCFA determination: Content of specific SCFA (butyric acid, acetic acid and propionic acid) will be determined in fecal samples using Gas Chromatography.|Outcome measurement at baseline|We analyzed the concentration of short fatty acids from faeces from 41 participants belonging to test (bread with added beta-glucans) or control group (bread without added beta-glucans).|||g/kg||Standard Deviation|Mean
2611761|NCT02039778|Primary|Progression-free Survival|The progression-free survival of patients with newly diagnosed HGG treated with concurrent ScRT and temozolomide, followed by post-radiation temozolomide (and compare to historical controls).|12 months|no data available due to no subject completed the study. data not collected||||||
2611647|NCT02041104|Primary|Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Glucose Concentrations)|"Pharmacokinetic outcome measures: Determination of insulin resistance with OGTT testing. Before and after oral consumption of 75 g of glucose, plasma glucose concentrations were measured at following times:~0 min - before oral consumption of 75 g glucose 30 min, 60 min and 120 min - after oral consumption of 75 g glucose"|Outcome OGTT measurements performed before dietary intervention|In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed before dietary intervention.|||uM/mL||Standard Deviation|Mean
2611648|NCT02041104|Primary|Oral Glucose Tolerance Test (OGTT) for Insulin Resistance Determination (Outcome Measures of Plasma Insulin Concentrations)|"Pharmacokinetic outcome measures: Determination of insulin resistance with OGTT testing. Before and after oral consumption of 75 g of glucose, plasma insulin concentrations were measured at following times:~0 min - before oral consumption of 75 g glucose 30 min, 60 min and 120 min - after oral consumption of 75 g glucose"|OGTT measurements performed before dietary intervention|In a population with metabolic syndrome or with high risk for metabolic syndrome development, OGTT was performed before dietary intervention.|||uM/mL||Standard Deviation|Mean
2611649|NCT02041104|Primary|Determination of Composition of Intestinal Microbiota From Fecal Samples|Fecal sampling for microbiologic analysis of microbiota composition: Composition of intestinal microbiota will be determined with a combination of two molecular techniques denaturating gradient gel electrophoresis (DGGE) and quantitative real time PCR (RT-PCR).|Outcome measurement at baseline|We analyzed faecal samples of 40 participants from the test and control group. Since DGGE method is only qualitative measurement, the only measurements of RT-PCR are shown. Results are presented as relative numbers of specific bacteria group ((number of specific bacteria group / all bacteria)*100).|||% of bacteria||Standard Deviation|Mean
2611650|NCT02041104|Primary|LDL-cholesterol Levels|LDL-cholesterol levels were determined before intervention|Baseline measurement|LDL-cholesterol levels were determined in both experimental groups.|||mmol/L||Standard Deviation|Mean
2611651|NCT02041104|Primary|HDL-cholesterol Levels|HDL-cholesterol levels were determined before diet intervention.|Baseline measurement|HDL-cholesterol levels were determined before diet intervention in both experimental groups.|||mmol/L||Standard Deviation|Mean
2611652|NCT02041104|Primary|Total Cholesterol Levels|Before the intervention, total cholesterol levels were determined.|Baseline outcome measurement|Total cholesterol levels were determined before diet intervention in both experimental groups.|||mmol/L||Standard Deviation|Mean
2611653|NCT02041091|Secondary|Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Injection Site Stratifications|Area under the concentration time curve in medium body weight group after the loading dose via auto-injector, assessed over the 14-day dosing interval, stratified by injection site. PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.|Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab|PK population (all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data) in medium body weight group, dosed by auto-injector.|||μg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2611654|NCT02041091|Secondary|Pharmacokinetics (PK): Cmax of Tabalumab Based on Injection Site Stratifications|Maximum serum concentration of tabalumab in medium body weight group, after the loading dose via auto-injector, assessed over the 14-day dosing interval, stratified by injection site. PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.|Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab|PK population (all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data) in medium body weight group, dosed by auto-injector.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2611655|NCT02041091|Secondary|Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score|"The SQAAQ is a 12-item questionnaire using a 7-point Likert scale (from Strongly Disagree as 1 to Strongly Agree as 7) that provides assessment of ease of use and confidence with using a prefilled syringe or auto-injector to administer a subcutaneous injection of drug. The 12 items are: A-Easy for me to learn how to use, B-Easy for me to unlock, C- Easy to hold in my hand when I inject my dose, D- Easy to inject my dose, E- Easy to know that my dose is complete, F- Easy to store the device in my refrigerator, G- Easy to remove needle shield/cover, H- Easy to pick up, I- Overall, easy to use, J- The device is stable against my skin during the injection, K- I am confident in my ability to use the device, L- I am confident my dose is complete."|Week 0, Week 4 and Week 8|Safety population: all randomized patients who received at least 1 dose of study treatment.|||units on a scale||Standard Deviation|Mean
2611656|NCT02041091|Secondary|Number of Participants Developing Anti-Tabalumab Antibodies|Participants with treatment-emergent anti-tabalumab antibodies were participants who had any samples from baseline up to and through Week 12 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Baseline is defined as the last non-missing observation on or prior to the date of the first injection of tabalumab. Percentage of participants with anti-tabalumab antibodies = (number of participants with treatment-emergent anti-tabalumab antibodies / number of participants assessed)*100.|Week 0 through Week 12|Safety population: all randomized participants who received at least 1 dose of study treatment. Participants with a baseline sample and at least 1 evaluable sample after administration of study drug OR participants with no baseline sample and all evaluable post-baseline samples.|||Participants|||Count of Participants
2611657|NCT02041091|Secondary|Number of Participants Reporting Incomplete Tabalumab Dose Administration|Participants reporting incomplete dose administration from the study drug administration log.|Week 0 through Week 12|Safety population: all randomized patients who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2611704|NCT02040766|Secondary|Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-week Treatment Period|The analysis of change from baseline in the weekly average of daily evening PEF across the 12-week treatment period was performed using a mixed model for repeated measures (MMRM) with effects due to baseline weekly average of daily evening PEF.|Day 1 (baseline), weeks 1-12|Full analysis set|||liters||Standard Error|Least Squares Mean
2611658|NCT02041091|Secondary|Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Body Weight|Area under the concentration time curve after the loading dose, assessed over the 14-day dosing interval, stratified by body weight (low <60 kilograms (kg), medium 60kg- 100kg, high >100kg). PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.|Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab|PK population: all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data. The analyses was conducted on tabalumab exposure parameter from both arms combined per the statistical analysis plan, since the tabalumab exposure was similar following prefilled syringe and auto-injector injections.|||ug*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2611659|NCT02041091|Secondary|Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight|Maximum serum concentration of tabalumab, after the loading dose, assessed over the 14-day dosing interval , stratified by body weight (low <60 kilograms (kg), medium 60kg- 100kg, high >100kg).PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using NCA methods to calculate the geometric mean.|Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab|PK population: all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data. The analyses was conducted on tabalumab exposure parameter from both arms combined per the statistical analysis plan, since the tabalumab exposure was similar following prefilled syringe and auto-injector injections.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2611660|NCT02041091|Primary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 14 Days (AUC 0-14) of Tabalumab After Loading Dose|Area under the concentration time curve after the loading dose, assessed over the 14-day dosing interval, stratified by device.PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using NCA methods to calculate the geometric mean.|Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab|PK population: all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data.|||microgram*hour per milliliter (ug*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2611661|NCT02041091|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab After Loading Dose|Maximum serum concentration of tabalumab, after the loading dose, assessed over the 14-day dosing interval, stratified by device.PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.|Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab|PK population: all randomized participants who received at least one dose of the study drug and had evaluable tabalumab PK data.|||microgram per milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2611662|NCT02040870|Secondary|Progression Free Survival (PFS) Per BIRC Assessment|PFS, defined as time from first dose of LDK378 to progression or death due to any cause.|40 months|The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib.|||Months||95% Confidence Interval|Median
2611663|NCT02040870|Secondary|Time to Response (TTR) Per BIRC Assessment|TTR, calculated as the time from first dose of LDK378 to first documented response (CR+PR). CR is the disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|40 months|The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib.|||Months||Full Range|Median
2611664|NCT02040870|Secondary|Disease Control Rate (DCR) Per BIRC Assessment|DCR, calculated as the percentage of participants with best overall response of CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD). CR is the disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. PD is at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. SD is neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Non-CR/Non-PD refers to best overall responses that are neither CR nor PD per RECIST 1.1 criteria for patients with non-measurable disease only at baseline.|40 months|The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
2611665|NCT02040870|Secondary|Duration of Response (DOR) Per BIRC Assessment|DOR, calculated as the time from the date of the first documented CR or PR to the first documented progression or all cause death. CR is the disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|40 months|The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib.|||months||95% Confidence Interval|Median
2611666|NCT02040870|Secondary|Overall Survival (OS)|OS, defined as time from first dose of LDK378 to death due to any cause.|40 months|The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib.|||Months||95% Confidence Interval|Median
2611667|NCT02040870|Secondary|Progression Free Survival (PFS) Per Investigator Assessment|PFS, defined as time from first dose of LDK378 to progression or death due to any cause.|40 months|The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib.|||Months||95% Confidence Interval|Median
2611668|NCT02040870|Secondary|Overall Intracranial Response Rate (OIRR) Per BIRC Assessment|OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who have measureable disease in the brain at baseline. CR is the disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|40 months|The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
2611669|NCT02040870|Secondary|Overall Intracranial Response Rate (OIRR) Per Investigator Assessment|OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who have measureable disease in the brain at baseline. CR is the disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|40 months|The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
2611670|NCT02040870|Secondary|Time to Response (TTR) Per Investigator Assessment|TTR, calculated as the time from first dose of LDK378 to first documented response (CR+PR). CR is the disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|40 months|The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib.|||Months||Full Range|Median
2611671|NCT02040870|Secondary|Disease Control Rate (DCR) Per Investigator Assessment|DCR, calculated as the percentage of participants with best overall response of CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD). CR is the disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. PD is at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. SD is neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Non-CR/Non-PD refers to best overall responses that are neither CR nor PD per RECIST 1.1 criteria for patients with non-measurable disease only at baseline.|40 months|The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
2611672|NCT02040870|Secondary|Duration of Response (DOR) Per Investigator Assessment|DOR, calculated as the time from the date of the first documented CR or PR to the first documented progression or all cause death. CR is the disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|40 months|The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib.|||months||95% Confidence Interval|Median
2611673|NCT02040870|Secondary|ORR Per RECIST 1.1 Per Blind Independent Review Committee (BIRC) Assessment|ORR per RECIST 1.1 calculated as the percentage of participants with a best overall response defined as complete response (CR) or partial response (PR). CR is the disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|40 months|The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
2611674|NCT02040870|Secondary|Overall Response Rate (ORR) Per RECIST 1.1 Per Investigator Assessment|ORR calculated as the percentage of participants with a best overall response defined as complete response (CR) or partial response (PR). CR is the disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR is at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|40 months|The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib.|||Percentage of participants|||Number
2611675|NCT02040870|Primary|Overall Summary of Adverse Events (AEs) - Per Occurence|Safety and tolerability of LDK378 at 750 mg once daily dose in Chinese adult patients with ALK-rearranged locally advanced or metastatic NSCLC|up to 41 months|The Full Analysis Set (FAS) consisted of enrolled patients who received at least one dose of ceritinib.|||occurrences|||Number
2611676|NCT02040870|Primary|Primary Pharmacokinetics (PK) Parameter of LDK378 After Daily Oral Dose: Tmax|Tmax is the time to reach maximum plasma concentration.|PK run-in phase (0h, 1h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 96h after PK run-in dose and predose Cycle 1 day 1 (C1D1)(approximately 120h after PK run in dose)) and C2D1(after one cycle (28 days) of continous dosing)(0h, 1h, 2h, 3h, 4h , 6h , 8h and 24h)|The Pharmacokinetic Analysis Set (PAS) consists of all patients who receive at least one dose of LDK378 and provide at least one evaluable PK sample.|||hour||Full Range|Median
2611677|NCT02040870|Primary|Primary Pharmacokinetics (PK) Parameter of LDK378 After Daily Oral Dose: Cmax|Cmax is the maximum (peak) concentration of drug in plasma|PK run-in phase (0h, 1h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 96h after PK run-in dose and predose Cycle 1 day 1 (C1D1)(approximately 120h after PK run in dose)) and C2D1(after one cycle (28 days) of continous dosing)(0h, 1h, 2h, 3h, 4h , 6h , 8h and 24h)|The Pharmacokinetic Analysis Set (PAS) consists of all patients who receive at least one dose of LDK378 and provide at least one evaluable PK sample.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2611678|NCT02040870|Primary|Primary Pharmacokinetics (PK) Parameter of of LDK378 After Daily Oral Dose: AUC0-24h|AUC0-24h: The area under the plasma concentration-time curve calculated from time zero to 24 hours.|Cycle 2 Day 1 (after one cycle (28 days) of continous dosing)(0h, 1h, 2h, 3h, 4h , 6h , 8h and 24h)|The Pharmacokinetic Analysis Set (PAS) consists of all patients who receive at least one dose of LDK378 and provide at least one evaluable PK sample.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2611679|NCT02040870|Primary|Primary Pharmacokinetics (PK) Parameters of of LDK378 After Daily Oral Dose: AUClast, AUC0-24h, AUCinf|"AUClast: The area under the concentration-time curve from time zero to the last measurable concentration time.~AUC0-24h: The area under the plasma concentration-time curve calculated from time zero to 24 hours.~AUCinf: Area under the plasma (serum, or blood) concentration versus time curve from time zero to infinity"|PK run-in phase (0h, 1h, 2h, 3h, 4h, 6h, 8h, 24h, 48h, 72h, 96h after PK run-in dose and predose Cycle 1 day 1 (C1D1)(approximately 120h after PK run in dose))|The Pharmacokinetic Analysis Set (PAS) consists of all patients who receive at least one dose of LDK378 and provide at least one evaluable PK sample.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2611680|NCT02040844|Secondary|Mean RQLQ Score|"The RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) was completed by subjects one year after the completion of the previous study (CP007).~The RQLQ is a validated method of assessing quality of life and has 28 questions in seven domains (activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems and emotional function). Subjects recalled how their rhinoconjunctivitis had been during the last week and responded to each question on a seven-point scale (0 = no impairment, 6 = maximum impairment). The questions were equally weighted, and the RQLQ score was the mean of the 28 questions and could range from zero to six.~A higher score indicated greater impact on quality of life and thus a low score indicated a better outcome."|1 year after completion of CP007|The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment).|||units on a scale||Standard Error|Least Squares Mean
2611681|NCT02040844|Secondary|Mean Allergy Medication Score (AMS)|"Mean AMS (Allergy medication score) in Cat-PAD treatment groups compared with placebo groups.~The use of rhinoconjunctivitis rescue medications was recorded by the subject for a period of 21 days, on a daily basis just before bedtime, approximately 1 year after completing the original CP007 study. Rescue medication use was scored based on a previously published system as follows: 0 = no allergy rescue medication used per day; 0.5 = at least one dose of antihistamine eye drops used per day; 1 = at least one dose of oral antihistamine used per day; 2 = at least one dose of intranasal corticosteroid used per day; 3 = at least one dose of systemic corticosteroid used per day. The score was according to the highest level of rescue medication used and was not additive."|1 year after completion of CP007|The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment).|||units on a scale||Standard Error|Least Squares Mean
2611682|NCT02040844|Secondary|Mean Component Scores of the TRSS (Ocular)|"Mean daily Total Ocular Symptom Score (TOSS) in Cat-PAD treatment groups compared to placebo groups~Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. TOSS was the sum of all the ocular symptom scores (itchy eyes; watery eyes; red eyes; sore eyes) and could range from 0 to 12. Higher TOSS reflected more severe symptoms.~Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks one year after completing the original CP007 study"|1 year after completion of CP007|The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment).|||units on a scale||Standard Error|Least Squares Mean
2611683|NCT02040844|Secondary|Mean Component Scores of the TRSS (Nasal)|"TNSS (Total nasal symptom score) was the sum of all the nasal symptom scores (runny nose; sneezing; blocked nose; itchy nose) and could range from 0 to 12. Higher TNSS reflected more severe symptoms.~Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks 1 year after completing the original CP007 study."|1 year after completion of CP007|The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment).|||units on a scale||Standard Error|Least Squares Mean
2611684|NCT02040844|Secondary|Mean TRSS|"Mean Total Rhinoconjunctivitis Symptom Score (TRSS) in Cat-PAD treatment groups compared with placebo.~Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome), therefore TRSS could range from 0 to 24. Higher TRSS reflected more severe symptom scores. Symptoms were scored daily for a period of approximately 3 weeks one year after completing the first study (CP007)."|1 year after completion of CP007|The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment).|||units on a scale||Standard Error|Least Squares Mean
2611685|NCT02040844|Primary|Mean Combined Score (CS) Consisting of TRSS/8+Allergy Medication Score[AMS])|"The primary endpoint was the mean Combined Score (CS) in Cat-PAD treatment groups compared with the mean CS in the placebo group. This was assessed one year after completing the original study (CP007).~CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Allergy Medication Score (AMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe) and the TRSS was divided by the number of symptoms to provide an average score per symptom of 0-3.~AMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The AMS score was not additive, and therefore the maximum AMS was 3 and the maximum CS was 6."|1 year after completing CP007|The number of subjects included in the analysis is the total number of subjects that completed the End of Year 1 assessments (1 year after the completion of CP007 and 2 years after the start of treatment).|||units on a scale||Standard Error|Least Squares Mean
2611686|NCT02040805|Post-Hoc|Longitudinal Follow-Up: Activities of Daily Living Scale, Hoarding (ADL-H)|The ADL-H is a 15-item self-report questionnaire that measures hoarding specific difficulties or problems that may impact daily functioning. It includes questions on activities affected by clutter or hoarding, problems in the home, and safety issues. Using the ADL-H, we obtained longitudinal follow-up data (defined as a second post-treatment assessment of hoarding specific difficulties or problems that may impact daily functioning at least three months following completion of treatment). For this study, a total score using the sum of all of the items was created, ranging from 0 to a total possible of 75. Higher scores indicate more severe impairment due to hoarding.|Post-hoc longitudinal analyses were conducted at three or more months' following the end of treatment. The range was 3-25 months, and the mean time to longitudinal follow up was 14 months.|All randomized participants who were not lost to follow-up.|||units on a scale||Standard Deviation|Mean
2611807|NCT02039375|Primary|Number of Participants Needing ICU Care/Interventions Within the First 24 Hours of IV tPA Administration||24 hours||||Participants|||Count of Participants
2611687|NCT02040805|Post-Hoc|Longitudinal Follow-Up: Saving Inventory-Revised (SI-R)|This is a 23-item self-report questionnaire that measures hoarding symptoms and their impact, including problems with acquisition, clutter, and difficulty discarding, as well as distress and impairment/interference. Using the SI-R, we obtained longitudinal follow-up data (defined as a second post-treatment assessment of hoarding symptom severity at least three months following completion of treatment). The total SI-R score was used, which ranges from 0-92, higher scores indicating more severe hoarding.|The post-hoc longitudinal data were collected at varying time points, but at least three months after the treatment ended. The range was 3 months to 25 months, with a mean of 14 months after treatment end.|All randomized participants who were not lost to follow-up.|||units on a scale||Standard Deviation|Mean
2611688|NCT02040805|Secondary|Activities of Daily Living Scale, Hoarding (ADL-H)|The ADL-H is a 15-item self-report questionnaire that measures hoarding specific difficulties or problems that may impact daily functioning. It includes questions on activities affected by clutter or hoarding, problems in the home, and safety issues. For this study, the score on each ADL-H item was summed to create a total score ranging from 0 to 75. Higher scores indicate more severe functional impairment due to hoarding.|Administered at baseline and after last treatment group (20 weeks later).|All randomized participants who were not lost to follow-up.|||units on a scale||Standard Deviation|Mean
2611689|NCT02040805|Primary|Saving Inventory-Revised (SI-R)|This is a 23-item self-report questionnaire that measures hoarding symptoms and their impact, including problems with acquisition, clutter, and difficulty discarding, as well as distress and impairment/interference. The SI-R is scored on a scale of 0-92. Higher scores indicate more severe hoarding, and scores of 42 and over are considered clinically significant hoarding. Although subscale scores can be calculated, this study uses total scores as the primary outcome.|Administered at screening before start of treatment groups and after last treatment group (20 weeks later).|All randomized participants who were not lost to follow-up.|||units on a scale||Standard Deviation|Mean
2611690|NCT02040792|Primary|Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)||Baseline to 28 days||||mL||Standard Error|Least Squares Mean
2611691|NCT02040779|Secondary|Participants With Findings During Oropharyngeal Examination During Treatment|Oropharyngeal examinations were performed at every visit by a qualified healthcare professional: during treatment visits are summarized. Any visual evidence of oral candidiasis during the treatment period of the study was evaluated by obtaining and analyzing a swab of the suspect area for culturing. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation.|Visits at weeks 2, 4, 8, 12|Safety population|||Participants|||Count of Participants
2611692|NCT02040779|Secondary|Participants With Potentially Clinically Relevant Abnormal Vital Sign Results During the Treatment Period|"Criteria for the select vital signs that showed a potentially clinically relevant abnormal result are:~Sitting systolic BP (low); <=90 mm Hg and decrease of >=20 mm Hg from baseline~Sitting diastolic BP (high): >=105 mm Hg and increase of >=15 mm Hg from baseline~Baseline is defined as the last available assessment prior to the first dose of double-blind study treatment (usually Day 1 predose)."|Baseline (Day 1 predose), Visits at weeks 2, 4, 8, 12|Safety population|||Participants|||Count of Participants
2611693|NCT02040779|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent 1 of the outcomes listed in this definition.|Day 1 up to Week 12|The safety population included all randomly assigned patients (ITT population) who took 1 or more doses of study drug. In this population, treatment was assigned based upon the treatment patients actually received, regardless of the treatment to which they were randomized.|||Participants|||Count of Participants
2611694|NCT02040779|Secondary|Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period|"A count of participants who were withdrawn from the study due to meeting stopping criteria. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient's overall clinical picture is consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety.~An example of alert criteria is:~FEV1 as measured at the study center is below the FEV1 stability limit value calculated at randomization visit (Day 1).~Other criteria as defined in the protocol."|Treatment period: Day 1 up to Week 12|Full analysis set|||Participants|||Count of Participants
2611695|NCT02040779|Secondary|Kaplan-Meier Estimates of Time to Study Drug Treatment Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period|"The time to patient study drug treatment withdrawal due to worsening asthma was defined as the number of days elapsed from the date of randomization to the date of withdrawal due to meeting stopping criteria. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient's overall clinical picture is consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety.~An example of alert criteria is:~FEV1 as measured at the study center is below the FEV1 stability limit value calculated at randomization visit (Day 1).~Other criteria as defined in the protocol."|Treatment period: daily from Day 1 up to Week 12|Full analysis set|||days||95% Confidence Interval|Median
2611705|NCT02040766|Secondary|Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period|The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF calculated across the 12-week treatment period was performed using a mixed model for repeated measures (MMRM) with effects due to baseline weekly average of daily trough morning PEF.|Day 1 (baseline), weeks 1-12|Full analysis set|||liters||Standard Error|Least Squares Mean
2611808|NCT02039219|Secondary|Discontinuation Rate During the Treatment and Follow-up Phases||Baseline to 180 days||||Events|||Number
2611696|NCT02040779|Secondary|Change From Baseline in Weekly Average of Total Daily Asthma Symptom Score Over the 12-Week Treatment Period|"Asthma symptom scores were recorded in the patient's diary each morning and evening before determining FEV1 and PEF and before administration of study or rescue medications.~The Daytime Symptom Score was recorded in the evening on a scale of 0 (No symptoms during the day) to 5 (Symptoms so severe that I could not go to work or perform normal daily activities) plus the Nighttime Symptom Score in the morning on a scale of 0 (No symptoms during the night) to 4 (Symptoms so severe that I did not sleep at all) for a total score range of 0-9.~Baseline was defined as the average of recorded daily asthma symptom scores (average of daytime and nighttime score) over the 7 days prior to the first dose of study treatment, including the morning assessment at the randomization visit.~The LS means, difference of LS means and its 95% CI, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy,"|Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12|Full analysis set|||units on a scale||Standard Error|Least Squares Mean
2611697|NCT02040779|Secondary|Change From Baseline in Weekly Average of Total Daily Use of Albuterol/Salbutamol Inhalation Aerosol Over Weeks 1-12|"Change from baseline in the use of rescue medication, albuterol/salbutamol, during the treatment period offers an indication of asthma control.~The LS means, difference of LS means and its 95% CI, and p-value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week and treatment by week interaction.~Baseline was defined as the average of recorded daily usage of albuterol/salbutamol inhalation aerosol over the 7 days prior to the first dose of double-blind study treatment, including morning usage at the randomization visit."|Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12|FAS|||inhalations||Standard Error|Least Squares Mean
2611698|NCT02040779|Secondary|Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period|"A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary.~Baseline in evening PEF is defined as the average of recorded evening PEF assessments over the 7-day window before randomization.~The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction."|Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12|Full analysis set|||L/minute||Standard Error|Least Squares Mean
2611699|NCT02040779|Secondary|Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 12-Week Treatment Period|"Change from baseline in the weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF by handheld spirometer over the 12-week treatment period.~PEF were determined twice daily, in the morning and in the evening, before administration of study drug or rescue medications. A handheld spirometer was provided to patients and used to determine the morning and evening PEF throughout the study. The spirometer was programmed to record the highest PEF obtained from 3 valid attempts.~Baseline was defined as the average of recorded trough morning PEF assessments over the 7 days prior to the first dose of double-blind study treatment, including the morning assessment at the randomization visit.~The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction."|Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12|Full analysis set (FAS)|||L/minute||Standard Error|Least Squares Mean
2611700|NCT02040779|Primary|Standardized Baseline-Adjusted Trough Morning Forced Expiratory Volume in One Minute (FEV1) Area Under the Effect Curve From Time Zero to 12 Weeks (AUEC(0-12wk)) by Actual Treatment Received|"The primary efficacy variable was the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) FEV1 AUEC(0-12wk). Pulmonary function measurements such as FEV1 were obtained electronically by spirometry at the randomization visit (Day 1), each treatment visit (Weeks 2, 4, 8 and 12) and any unscheduled visit (such as the early termination visit). This summary is based on observed values recorded as 'best attempt'.~The least-square (LS) means, difference of LS means and its 95% confidence interval (CI), and p-value represent the results obtained from the analysis of covariance with covariate adjustment for baseline, sex, age, current asthma therapy, and treatment."|Baseline (Day 1 predose), weeks 2, 4, 8 and 12|The full analysis set (FAS) included all patients in the intent to treat (ITT) population who received at least 1 dose of study drug and had at least 1 postbaseline trough morning (pre-dose and pre-rescue bronchodilator) assessment of FEV1.|||liters||Standard Error|Least Squares Mean
2611701|NCT02040766|Secondary|Kaplan-Meier Estimates For Time to Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-week Treatment Period|"Time to withdrawal due to meeting stopping criteria was defined as number of days elapsed from the date of first dose of double-blind study treatment to the date of withdrawal due to meeting stopping criteria.~Kaplan-Meier estimates (median and 95% CI of the median) are not applicable if the proportion of participants withdrawn is less than 0.5."|Day 1 to 12 weeks|Full analysis set|||Days||95% Confidence Interval|Median
2611702|NCT02040766|Secondary|Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1-12|The total daily asthma symptom score is the average of the daytime and nighttime scores analyzed using an mixed model for repeated measures (MMRM). Baseline was defined as the average of recorded morning and evening asthma symptom scores over the 7 days before randomization. Daytime Scores range from 0=No symptoms during the day to 5=Symptoms so severe that I could not go to work or perform normal daily activities; Nighttime Scores range from 0=No symptoms during the night to 4=Symptoms so severe that I did not sleep at all. The daily asthma symptom score was therefore 0 - 9 with 0=no symptoms during the day or night and 9=severe symptoms both day and night.|Day 1 (baseline), weeks 1-12|Full analysis set|||units on a scale||Standard Error|Least Squares Mean
2611703|NCT02040766|Secondary|Change From Baseline in the Weekly Average of Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol (Number of Inhalations) Over Weeks 1-12|The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) across the 12 weeks was analyzed using a mixed model for repeated measures (MMRM).|Day 1 (baseline), weeks 1-12|Full analysis set|||Number of inhalations||Standard Error|Least Squares Mean
2611706|NCT02040766|Primary|Standardized Baseline-adjusted Trough Morning Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk))|Trough morning FEV1 measurements were taken pre-dose and pre-rescue bronchodilator treatment for asthma. Baseline was defined as baseline trough morning percent predicted FEV1. Pulmonary function measurements (including FEV1) were obtained electronically by spirometry. All pulmonary function test data were submitted to a central reading center for evaluation. The highest ('best attempt') FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 8 attempts) was used.|Day 1 (baseline), Weeks 2, 4, 8, 12|The full analysis set (FAS) included all patients in the ITT population who received at least 1 dose of study drug and had at least 1 post baseline trough morning (pre-dose and pre-rescue bronchodilator) assessment of percent predicted FEV1.|||liters||Standard Error|Least Squares Mean
2611707|NCT02040623|Primary|Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks.|Change from baseline (Visit 1) of total CFS score at 12 weeks. Total CFS score range 0-20, where '0' represents no fluorescein staining of any region and '20' represents severe staining the entire cornea.|Baseline to 12 weeks|The per-protocol (PP) population excludes subjects with significant protocol deviations or with early study termination|||units on a scale||Standard Deviation|Mean
2611708|NCT02040584|Secondary|Concentration of p-P70S6K|"the biomarker of personal response to everolimus, monitoring of the activity of the target, kinase P70 S6, in its phosphorylated form at Thr389.~EVR=everolimus Cmin=minimum concentration"|weeks 6,8,12,18,24,36,52 at 0 (Cmin), and 1 (C1h) hrs post-dose.||||ng/ml||Standard Deviation|Mean
2611709|NCT02040584|Secondary|Percentages of Participants With HCV-positive and HCV Genotype|"The viral load of HCV-RNA and HCV genotype was assessed in HCV-positive patients.~The term genotype was used to describe strains of HCV that vary but were related to the virus. Worldwide, there were 11 primary groups of HCV genotypes designated by the numbers from 1-11, with the most common in our setting being subtypes 1a, 1b, 2 and 3, which were identified in the local laboratory according to their usual testing methods."|approximately 2 years and 2 months|ITT|||Percentages of participants|||Number
2611710|NCT02040584|Secondary|Severity of Rejection|"Severity of acute rejection and treated BPAR was graded according to Banff criteria.~Grade of acute rejection according to Banff criteria: mild, moderate, severe."|Throughout study period, approximately 2 years and 2 months|ITT|||Percentages of participants|||Number
2611711|NCT02040584|Secondary|Time to Rejection|"Time to acute rejection was calculated from the date of transplantation. Acute rejection date was taken from biopsy date, as the date of rejection was not collected.~Time to treated BPAR was calculated from the date of transplantation."|Throughout study period, approximately 2 years and 2 months|ITT|||months||Standard Deviation|Mean
2611712|NCT02040584|Secondary|Percentage of Participants With Acute Rejection, BPAR, and Treated BPAR|"Liver biopsy had to be performed in all cases where acute rejection was suspected. Results of the biopsy were interpreted by the local pathologist (who did not known the treatment given to the patient) according to the Banff classification (1997).~Biopsy-proven acute rejection (BPAR) defined as clinical suspicion of acute rejection confirmed in biopsy.~Treated BPAR was deemed to be an episode of acute rejection in which the interpretation of the local pathologist showed that it reached any grade of acute rejection under the Banff classification, and for which anti-rejection therapy was administered.~Loss of the liver allograft was deemed to have occurred the day that the patient was again included on the waiting list for liver transplant, the day he or she received another allograft or upon the death of the patient.~All suspected hepatic allograft rejections were considered acute rejection"|Throughout the study period, approximately 2 years and 2 months|ITT|||Percentages of participants|||Number
2611713|NCT02040584|Secondary|Percentage of Participants With Incidence of Proteinuria|The incidence of proteinuria (≥0.5-0.9 g/day, ≥1.0-2.9 g/day and ≥3.0 g/day) was assessed throughout follow-up in both treatment groups. Proteinuria was defined as protein/creatinine ratio ≥ 0.5.|Screening visit, week 1,4,18,24, and 52|ITT|||Percentages of participants|||Number
2611714|NCT02040584|Secondary|Urine Protein/Creatinine Ratio|The urine protein/creatinine ratio was assessed throughout follow-up in both treatment groups.|Screening visit, week 1,4,18,24, and 52|ITT|||mg/g||Standard Deviation|Mean
2611715|NCT02040584|Secondary|eGFR Values(MDRD-4 Formula) According to the MELD Score|Model for End Stage Liver Disease (MELD) score: ≤14, 15-19, 20-24, 25-29, ≥30. The higher the number indicates the urgency for transplant.|Screening visit (transplant), weeks 1,4,12,24,36 and 52 post-transplant|ITT population (patients with MDRD-4 values).|||ml/min/1.73m^2||Inter-Quartile Range|Median
2611716|NCT02040584|Secondary|Changes in eGFR Based on the MDRD-4 Formula|"Kidney function was assessed over time by changes in eGFR according to the MDRD-4 formula. The MDRD-4 formula (Levey et al., 2000) was used based on serum concentration of creatinine (conventional units): eGFR (mL/min/1.73 m2) = 186 x (serum creatinine)-1.154 x (age)-0.203 x (0.742 if female) x (1.210 if of African descent).~Units: serum creatinine (mg/dL); age (years)."|Screening visit (transplant), weeks 1,4,12,24,36 and 52 post-transplant|ITT|||ml/min/1.73m2||Standard Deviation|Mean
2611717|NCT02040584|Secondary|Changes in Creatinine Clearance - Cockcroft-Gault Formula|"Kidney function was assessed over time by creatine clearance based on the Cockcroft-Gault formula.~Estimated creatinine clearance (mL/min) = [(140 - age) x (weight) x (0.85 if female)] / (72 x serum creatinine).~Units: age (years); weight (kg); serum creatinine (mg/dL). The values of the eGFR according to the creatinine clearance (Cockcroft-Gault formula) for the ITT population were ml/min/1.73 m^2."|Screening visit (transplant), weeks 1,4,12,24,36 and 52 post-transplant|ITT|||ml/min/1.73m^2||Standard Deviation|Mean
2611718|NCT02040584|Primary|Percentages of Participants Showing Clinical Benefit by Renal Function Stratification|Clinical benefit is defined as: • an improvement in 1 or 2 ranges of the eGFR, according to MDRD-4 at Week 52 post-transplant in patients with values of 30-<45 or 45-<60 mL/min/1.73 m2 in Week 4. or • stabilisation of eGFR in patients with values ≥60 mL/min/1.73 m2 at Week 4 and maintained at Week 52 post-transplant.|week 4, week 52.|ITT|||Percentages of partcipants|||Number
2611729|NCT02040428|Secondary|Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application|The number of subjects achieving hemostatic success at 6 minutes following treatment application with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.|Intraoperative, 6 minutes following treatment application|The secondary endpoint analyses were based on the Intent to Treat (ITT) analysis set.|||Participants|||Number
2611719|NCT02040532|Other Pre-specified|Quality of Life-Menopause Specific|"The Quality of life-Menopause specific is assessed by the Menopause Specific Quality of Life (MENQOL).~The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to six (extremely bothersome) scale. Means are computed for each subscale by dividing the sum of the domain's items by the number of items within that domain. Non-endorsement of an item is scored a 1 and endorsement a 2, plus the number of the particular rating, so that the possible score on any item ranges from 1-8. Total score also ranges from 1-8."|Baseline, study completion at 7 weeks|Analyzable population includes all 20 completers of the study, since all 20 completers of the study had MENQOL data at baseline and study completion.|||scores on a scale||Full Range|Mean
2611720|NCT02040532|Other Pre-specified|Quality of Life-Overall|Quality of life-Overall was assessed with the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). The Q-LES-Q is a 16-item self-report questionnaire that assesses enjoyment of and satisfaction with life. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70 with higher scores indicating higher quality of life enjoyment and satisfaction.|Baseline, study completion at 7 weeks|Analyzable population includes all 20 completers of the study, since all 20 completers of the study had Q-LES-Q data at baseline and study completion.|||scores on a scale||Full Range|Mean
2611721|NCT02040532|Primary|Sleep Quality and Disturbances Over Past Month|"Sleep quality and disturbances during the past month were assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI also incorporates daytime functioning into the total score.~In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality."|Baseline, study completion at 7 weeks|Analyzable population includes all 20 completers of the study, since all 20 completers of the study had PSQI data at baseline and study completion.|||scores on a scale||Full Range|Mean
2611722|NCT02040532|Primary|Severity of Insomnia|"Severity of insomnia was measured throughout the study using the Insomnia Severity Index (ISI) .The ISI is a 7-item scale that evaluates the severity of insomnia retrospectively over the past week. The scale is more specific to insomnia symptoms than the Pittsburgh scale (PSQI), which focuses more broadly on overall sleep quality.~The ISI score ranges from a minimum of 0 to 28. A score of 0-7=no clinically significant insomnia, 8-14=subthreshold insomnia, 5-21=clinical insomnia (moderate severity), 22-28=clinical insomnia (severe), with higher values indicating more severe insomnia."|Baseline, study completion at 7 weeks|Analyzable population includes all 20 completers of the study, since all 20 completers of the study had ISI data at baseline and study completion.|||scores on a scale||Full Range|Mean
2611723|NCT02040532|Primary|Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Nighttime|Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night. Vasomotor symptoms were also systematically assessed at baseline, week 4, and week 7 using the Hot Flash-Related Daily Interference Scale (HFRDIS), a 10-item self-report questionnaire to determine perceived hot flash interference with quality of life and daily activities.|Baseline, study completion at 7 weeks|Though 20 participants completed the study, the analyzable population includes only the 19 completers who have VMS data for both baseline and the final visit.|||vasomotor symptoms (VMS) per night||Full Range|Mean
2611724|NCT02040532|Primary|Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Daytime|Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night. Vasomotor symptoms were also systematically assessed at baseline, week 4, and week 7 using the Hot Flash-Related Daily Interference Scale (HFRDIS), a 10-item self-report questionnaire to determine perceived hot flash interference with quality of life and daily activities.|Baseline, study completion at 7 weeks|Though 20 participants completed the study, the analyzable population includes only the 19 completers who have VMS data for both baseline and the final visit.|||vasomotor symptoms (VMS) per day||Full Range|Mean
2611725|NCT02040532|Primary|Reason for Non-tolerability and Discontinuation of Gabapentin|Reason why subjects who initiated treatment with gabapentin chose to discontinue before study completion|Baseline, Week 4 Visit, and study completion at 7 weeks|Four subjects initiated treatment with gabapentin but discontinued prior to study completion due to side effects.|||Participants|||Count of Participants
2611726|NCT02040532|Primary|Tolerability of Gabapentin|Tolerability of gabapentin was assessed by self-report at the week 1, week 4 and week 7 contacts by asking participants to complete the SAFTEE-SI and CPFQ questionnaires and prompting subjects to report any adverse events at each study visit. Tolerability of gabapentin is defined as the proportion of participants that is able to increase the dose from 300-mg to 600-mg and to remain on the higher dose for the duration of the trial.|Baseline, Week 4 visit, and study completion at 7 weeks|All 26 participants who initiated treatment with gabapentin were included in this analysis.|||Participants|||Count of Participants
2611727|NCT02040428|Secondary|Number of Participants With Re-bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment|The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had intra-operative re-bleeding requiring treatment at the TBS|Intra-operative, prior initiation of final chest wall closure.||||Participants|||Number
2611728|NCT02040428|Secondary|Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application|The number of subjects achieving hemostatic success at 10 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.|Intraoperative, 10 minutes following treatment application||||Participants|||Number
2611730|NCT02040428|Primary|Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.|Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure|Intraoperative, 3 minutes following treatment application|The primary endpoint analysis was based on the Intent to Treat (ITT) analysis set, consisting of all randomized subjects.|||Participants|||Number
2611731|NCT02040116|Primary|Grade of Infusion Related Reactions With Rapid Infusion Will be Reported|Patients are given therapy on day 1 and if infusion is tolerated with < grade 2 reaction based on the CTCAE v4 then then will proceed to rapid infusion on day 14 which is given over 90 minutes. The grade of infusion reaction is measured for all patients and in all infusions given. According to the National Cancer Institute, there are 5 grades of IRR. In general, grade 1 reactions are classified as asymptomatic or only mild symptoms that do not require intervention. Grade 2 reactions are classified as moderate with minimal, local, or noninvasive interventions required. Grade 3 reactions are classified as severe and medically significant, but not immediately life-threatening. These reactions require hospitalization or prolongation of a current hospitalization. Grade 4 reactions are classified as life-threatening with urgent interventions required. Grade 5 reactions are classified as death related to an adverse drug event.|14 Days|Due to their being no reactions, the Grade of reactions for Standard infusion will and can not be reported, as the lowest grade requires there to be a reaction.||||||
2611732|NCT02040116|Secondary|Change in Chair Time With Rapid Infusion Will be Reported|The amount of time spent administering the rituximab will be compared to the time from the first infusion to the second infusion. The change was calculated from two time points as the value at the later time point minus the value at the earlier time point.|14 Days||||Hours||Full Range|Mean
2611733|NCT02040116|Primary|Incidence of Infusion Related Reactions With Rapid Infusion Will be Reported|Patients are given therapy on day 1 and if infusion is tolerated with < grade 2 reaction based on the CTCAE v4 then then will proceed to rapid infusion on day 14 which is given over 90 minutes. The number of infusion reaction is measured for all patients and in all infusions given.|14 Days||||infusion reactions|||Number
2611734|NCT02040077|Secondary|Percent Participants Who Would Recommend the Intervention to a Family Member or Friend.|Participant willingness (yes or no) to recommend the intervention to a family member or friend.|Immediately after the intervention (an average of 10 minutes).||||Participants|||Count of Participants
2611735|NCT02040077|Primary|Knowledge Gain|"The primary outcome is based on performance in the randomized, controlled trial and is change from baseline on a knowledge test that is administered immediately before and after the intervention.~At the time of the study, no validated scales to assess general information regarding overdose in a true/false manner were available. Therefore the study developed a scale for the purpose of measuring knowledge increase. The scale included 51 items, rated as true, false, or I don't know (to discourage random guessing from resulting in accurate responses accidentally). The answers to all items were included as part of the intervention content so it was possible for every answer to be learned. The scale was summed together as a single measure of number correct responses (range 0-51) with no subscales. Higher values indicated more correct responses."|Before the intervention (pre-test) and immediately after the intervention (post-test), an average of 10 minutes.||||units on a scale||Standard Deviation|Mean
2611736|NCT02039947|Secondary|Overall Survival (OS) for Each Cohort|Overall survival (OS) is defined as the time from the first dose until death due to any cause. No hypothesis testing completed for cohort A,B,C and D|From the first dose to death|All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population|||Month||95% Confidence Interval|Median
2611737|NCT02039947|Secondary|Progression-free Survival (PFS) for Each Cohort Based on Investigator Assessment|PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause. No hypothesis testing completed for cohort A,B,C and D|From the first dose to the earliest date of disease progression or death|All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population|||Month||95% Confidence Interval|Median
2611738|NCT02039947|Secondary|Duration of Intracranial, Extracranial and Overall Response for Each Cohort|Duration of intracranial, extracranial and overall response, are defined as the time from first documented evidence of CR or PR until time of first documented intracranial, extracranial, or overall disease progression. No hypothesis testing completed for cohort A,B,C and D|From first documented evidence of CR or PR until time of first documented intracranial, extracranial, or overall disease progression|All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population|||Month||95% Confidence Interval|Median
2611739|NCT02039947|Secondary|Overall Response (OR) for Each Cohort|the number of subjects with a confirmed overall Complete response (CR) or Partial response (PR) by investigator assessment using the Response evaluation criteria in solid tumors (RECIST 1.1 criteria). To determine the overall response, all target and non-target lesions will be assessed using modified RECIST 1.1 criteria.|Approximately 2 years|All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population|||Number of participants|||Number
2611740|NCT02039947|Secondary|Extracranial Response Rate (ER) for Each Cohort|Extracranial Response Rate was defined as the percentage of participants with Complete response (CR) or Partial response (PR) at anytime. This is based on investigator-assessed response. No hypothesis testing completed for cohort A,B,C and D|Approximately 2 years|All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population|||Number of participants|||Number
2611741|NCT02039947|Secondary|Disease Control for Intracranial, Extracranial and Overall Response for Each Cohort|Disease Control rate is defined as the percentage of subjects achieving a confirmed intracranial/extracranial/overall CR or PR or SD or Non-CR/Non-PD. This is based on investigator-assessed response. No hypothesis testing completed for cohort A, B,C and D|Approximately 2 years|All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population|||Number of participants|||Number
2612223|NCT02035475|Secondary|Surgical Complications|"Evaluate perioperative and postoperative surgical outcomes at 4 months after surgery. Possible outcomes include no complications (0), minor complications (1), and major complications (2)."|4 months||||participants|||Number
2611742|NCT02039947|Secondary|Intracranial Response Rate of Cohorts B, C and D|The intracranial response rate is defined as the percentage of subjects achieving a confirmed intracranial CR or PR. This is based on investigator-assessed best intracranial response. No hypothesis testing completed for cohort A, B,C and D|Approximately 2 years|All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population|||Number of participants|||Number
2611743|NCT02039947|Primary|Intracranial Response (IR) Rate in Cohort A|The intracranial response rate is defined as the percentage of subjects achieving a confirmed intracranial CR or PR. This is based on investigator-assessed best intracranial response.|From the start of treatment until disease progression or the start of new anti-cancer therapy|All Treated population - All subjects who receive at least one dose of study medication are comprised the All Treated subjects (ATS) population.|||Number of participants|||Number
2611744|NCT02039908|Secondary|Endpoint Medication Dose|Dose of medication reported in mg/kg/day|End of Phase 2 School Year|Only participants who completed the entire school year are used in endpoint medication dosing calculations.|||Mg/kg/day||Standard Deviation|Mean
2611745|NCT02039908|Secondary|Time to First Dose Increase|The amount of time elapsed before a child requires a dose increase during the school year will be measured in months.|10 months||||Months||Standard Deviation|Mean
2611746|NCT02039908|Primary|Number of Dose Changes Required Per Protocol|Monthly evaluations of medication efficacy will be used to determine whether dose adjustments are needed due to anticipated tolerance effects.|10 months|All participants who began Phase 2 were included in analysis|||Number of Increases||Standard Deviation|Mean
2611747|NCT02039856|Secondary|Patient Emergency Room Visits|Average number of patient emergency room visits for any cause in a year|baseline to 24-month|Patients only. One patient in the EBQI arm had missing outcome information and was excluded from the analysis.|||Average visits per year for all patients||Standard Deviation|Mean
2611748|NCT02039856|Secondary|Patient VA Hospitalization|Average number of patient hospitalization for any cause in a year|Baseline to 24-month|Patients only. One patient in the EBQI arm had missing outcome information and was excluded from the analysis.|||Average visits per year for all patients||Standard Deviation|Mean
2611749|NCT02039856|Secondary|Patient VA Women's Health Care Visits Per Year|Average number of patient visits to VA women's health care per year|Baseline to 24month|Patients only. One patient in the EBQI arm had missing outcome information and was excluded from the analysis.|||Average visits per year for all patients||Standard Deviation|Mean
2611750|NCT02039856|Secondary|Patient VA Primary Care Visits Per Year|Average number of visits to VA primary care per year|Baseline to 24month|Patients only. One patient in the EBQI arm had missing outcome information and was excluded from the analysis.|||average visits per year for all patients||Standard Deviation|Mean
2611751|NCT02039856|Secondary|Providers and Staff Burnout|"Burnout was measured using one item: How often does the following statement apply to you: I feel burned out from my work with options for 1.Never, 2. A few times a year, 3. Every month, 4. A few times a month, 5. Every week, 6. A few times a week, 7. Every day. We recoded the responses into a binary value: never/less than a few times a month (1-4) and every week-to-everyday (5-7)."|24-month|Primary care and women's health providers and staff. The analysis was based on cases with non-missing burnout data. There were 30 missing cases in the EBQI arm and 10 in the control arm.|||Participants|||Count of Participants
2611752|NCT02039856|Secondary|Team Functioning|Perceived team functioning of primary care and women's health providers and staff, measured based on responses to 7 survey items. The team functioning score ranged from 1 to 5 , with the higher score indicating better team functioning.|Baseline to 24-month|Primary care and women's health providers and staff. The analysis was based on cases with non-missing outcome data. There are 80 missing cases in the EBQI arm and 74 in the control arm.|||score on a scale||Standard Deviation|Mean
2611753|NCT02039856|Secondary|Providers' and Staff Gender Sensitivity|Gender sensitivity score based on 10 survey items related to providers' and staff's sensitivity towards women Veterans during patient care. The score ranged from 1 to 5 with the higher score reflecting greater gender sensitivity toward women Veterans.|Baseline to 24-month|Primary care and women's health providers and staff. The analysis was based on cases with non-missing outcome data. There were 28 missing cases in the EBQI arm and 9 missing in the control arm.|||score on a scale||Standard Deviation|Mean
2611754|NCT02039856|Primary|WH-PACT Achievement|The Women's Health Patient-Aligned Care Team achievement, based on four patient-reported measures of access to care, patient-provider communication, comprehensiveness of care, and gender-appropriateness of care. The WH-PACT achievement is an aggregate score from -4 to +4, with the higher score meaning better PACT achievement.|Baseline to 24-month|The analysis included the patients who had completed the 24-month survey. One patient in the EBQI arm had missing data for outcome measure and was excluded from the analysis.|||Participants|||Count of Participants
2611755|NCT02039817|Primary|Cmax|Maximum concentration (Cmax)|48 hours||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2611756|NCT02039817|Secondary|Levels of cCK18|Biomarker cCK18 (Cleaved cytokeratin 18) PK evaluations from pre-dose to 48 hours|48 hours||||U/L||Inter-Quartile Range|Median
2611757|NCT02039817|Primary|AUC|Area under the plasma concentration curve (AUC) parameters include AUC0-12, AUCinf, AUClast|48 hours|7 subjects were used in the calculation of AUC0-inf for the healthy volunteer group as one subject had no identifiable terminal log-linear phase.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2611758|NCT02039778|Secondary|Quality of Life|The impact of ScRT on health-related quality of life (HRQOL) as assessed by EORTC Quality of Life Questionnaire (EORTC QLQ-C30)/Brain Cancer Module (BCM 20), Functional Assessment of Cancer Therapy with Brain Subscale (FACT-BR), and Activities of Daily Living Scale (ADLS) during ScRT.|36 months|no data available due to no subject completed the study. data not collected||||||
2611759|NCT02039778|Secondary|Neurocognition|The potential neurocognitive effects of ScRT by the Hopkins Verbal Learning Test (HVLT), Mini-mental status exam (MMSE), Trail Making Tests A/B (TMT), and Controlled Word Association Test (COWAT).|36 month|no data available due to no subject completed the study. data not collected||||||
2611760|NCT02039778|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The short-and long-term toxicity of ScRT (and compare to historical controls).|36 months||||Participants|||Count of Participants
2611762|NCT02039778|Primary|Overall Survival|The overall survival of patients with newly diagnosed high-grade glioma (HGG) treated with concurrent ScRT and temozolomide, followed by post-radiation temozolomide (and compare to historical controls).|12 months||||Participants|||Count of Participants
2611763|NCT02039726|Secondary|Event-free Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy|Event-free survival is defined as the time (in weeks) from randomization until documented refractory disease, relapse after complete composite remission (CRc), or death from any cause, whichever is observed first.|At approximately 3 years 9 months|Event-free survival was assessed in the intent-to-treat (ITT) analysis set.|||weeks||Inter-Quartile Range|Median
2611764|NCT02039726|Primary|Overall Survival in Participants That Received Quizartinib Versus Salvage Chemotherapy|Overall Survival is defined as the time (in weeks) from the date of randomization to the date of death due to any cause. Median and quartiles are calculated using the Kaplan-Meier method.|At approximately 3 years 9 months||||weeks||Inter-Quartile Range|Median
2611765|NCT02039687|Secondary|Frequency of Adverse Events, Serious Adverse Events, and Laboratory Parameters|Patients reporting at least one treatment emergent adverse event (TEAE) or serious TEAE|Continuous reporting from baseline through 16 weeks||||Participants|||Count of Participants
2611766|NCT02039687|Secondary|Change in the Scores of the SFNSL, BPI, NPSI, and FAS Questionnaires|"Change in mean score from baseline to Day 28 is recorded for each outcome. Brief Pain Inventory (BPI), Pain Severity - scale of 0 (no pain) to 10 (worst pain imaginable) in 4 time frames, averaged.~BPI, Pain Interference - scale of 0 (does not interfere) to 10 (completely interferes) how pain interferes with 7 lifestyle parameters, averaged.~Small Fiber Neuropathy Screening List (SFNSL) - scale of 0 to 84 (higher score indicates greater neuropathy), sum of 21 questions.~Neuropathic Pain Symptom Inventory (NPSI) - scale of 0 (least pain) to 10 (most pain) in 10 questions, summed. Total score range from 0 to 100.~Fatigue Assessment Scale (FAS) - scale of 1 (never) to 5 (always) in 10 questions related to fatigue, summed. Total score range from 0 to 50, with 0 being the best possible score and 50 the worst.."|Baseline to 28 days|Questionnaires incomplete for some subjects|||units on a scale||Standard Deviation|Mean
2611767|NCT02039687|Secondary|Change in Intra-epidermal Nerve Fiber Density (IENFD)|Measurement of small fiber density in skin biopsies. Density is reduced in sarcoidosis patients, an indication of neuropathy.|Baseline and 28 days||||fibers/mm||Standard Deviation|Mean
2611768|NCT02039687|Secondary|Change in the 6 Minute Walk Test|Measurement of the distance a patient can walk in 6 minutes|Baseline and 28 days||||meters||Standard Deviation|Mean
2611769|NCT02039687|Primary|Change in Corneal Nerve Fiber Area|Measurement of corneal nerve fiber area is a non-invasive procedure performed at baseline and at the end of dosing and at 12 weeks follow-up. The nerve fiber area in sarcoidosis patients is reduced compared to normal humans, a measurement of small fiber loss.|Baseline and 28 days||||µm^2||Standard Deviation|Mean
2611770|NCT02039674|Secondary|Part 2 Cohorts G+ and G-: Duration of Response (DOR)|For participants who demonstrated a confirmed response (Complete Response [CR]: Disappearance of all target lesions or Partial Response [PR]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. Per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR was assessed by BICR.|Up to approximately 2 years|The analysis population consisted of all randomized Cohort G participants who experienced a confirmed response (CR or PR).|||Months||Full Range|Median
2611771|NCT02039674|Secondary|Part 2 Cohorts G+ and G-: Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause.|Up to approximately 2 years|The analysis population consisted of all randomized Cohort G participants.|||Months||95% Confidence Interval|Median
2611772|NCT02039674|Secondary|Part 2 Cohorts G+ and G-: Progression-Free Survival (PFS)|PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. PFS was assessed by BICR.|Up to approximately 2 years|The analysis population consisted of all randomized Cohort G participants.|||Months||95% Confidence Interval|Median
2611773|NCT02039674|Primary|All Cohorts: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)|DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4. A DLT was defined as any of the following events: Grade 4 non-hematologic toxicity (not laboratory); Grade 4 hematologic toxicity lasting ≥7 days; Grade 3 non-hematologic toxicity (not laboratory, specifically nausea, vomiting and diarrhea) lasting >3 days despite optimal supportive care; Any Grade 3 or Grade 4 non-hematologic laboratory value requiring treatment or hospitalization, or persisting for >1 week; Febrile neutropenia Grade 3 or Grade 4; Qualifying thrombocytopenia <25,000/mm^3; Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Missing >10% of erlotinib or gefitinib doses as a result of adverse events (AEs) during the DLT window of observation; or Grade 5 toxicity.|Cycle 1 (Up to 21 days)|The DLT evaluable population consisted of all participants who completed the first cycle of study treatment or who discontinued from the study due to a drug-related AE.|||Participants|||Count of Participants
2611774|NCT02039674|Primary|Part 2 Cohorts D4 and H: Objective Response Rate (ORR)|For participants who demonstrated a confirmed response (Complete Response [CR]: Disappearance of all target lesions or Partial Response [PR]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. Per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR was assessed by BICR.|Up to approximately 2 years|The analysis population consisted of all treated Cohort D4 and Cohort H participants. One Cohort H participant was excluded from the efficacy analysis population due to a protocol violation. This participant did not have non-small cell lung cancer.|||Percentage of Participants||95% Confidence Interval|Number
2611775|NCT02039674|Primary|Part 2 Cohorts G+ and G-: Objective Response Rate (ORR)|ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).|Up to approximately 2 years|The analysis population consisted of all randomized Cohort G participants.|||Percentage of Participants||95% Confidence Interval|Number
2611776|NCT02039505|Secondary|Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Maintenance Phase|Blood samples were collected, and serum neutralizing AVA was determined only for the AVA-positive samples in a laboratory by means of ECL assay.|Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug (Up to approximately 170 weeks)|Participants who underwent proper AVA test out of the FAS, the participants who received at least one dose of study drug in the maintenance phase were analyzed at the given timepoint. Number analyzed is the number of participants with evaluable data at the given time-point.|||Participants|||Count of Participants
2611777|NCT02039505|Secondary|Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Induction Phase|Blood samples were collected, and serum neutralizing AVA was determined only for the AVA-positive samples in a laboratory by means of ECL assay.|Weeks 0, 10 and 16 weeks after the last dose of study drug (Up to approximately 170 weeks)|"Participants who underwent proper AVA test out of the FAS in the induction phase and the participants who received at least one dose of study drug in the Cohort 2 were analyzed at the given timepoint. Number analyzed is the number of participants with evaluable data at the given time-point."|||Participants|||Count of Participants
2611778|NCT02039505|Secondary|Number of Participants With Anti-vedolizumab Antibodies (AVA) in Maintenance Phase|Blood samples were collected and tested for serum concentration of anti-vedolizumab antibodies in a laboratory by means of ECL assay.|Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug (Up to approximately 170 weeks)|Participants who underwent proper AVA test out of the FAS, the participants who received at least one dose of study drug in the maintenance phase were analyzed at the given timepoint. Number analyzed is the number of participants with evaluable data at the given time-point.|||Participants|||Count of Participants
2611779|NCT02039505|Secondary|Number of Participants With Anti-vedolizumab Antibodies (AVA) in Induction Phase|Blood samples were collected and tested for serum concentration of anti-vedolizumab antibodies in a laboratory by means of electrochemoluminescent (ECL) assay.|Weeks 0, 10 and 16 weeks after the last dose of study drug (Up to approximately 170 weeks)|"Participants who underwent proper AVA test out of the FAS in the induction phase and, the participants who received at least one dose of study drug in the Cohort 2 were analyzed at the given timepoint. Number analyzed is the number of participants with evaluable data at the given time-point."|||Participants|||Count of Participants
2611780|NCT02039505|Secondary|Serum Vedolizumab Concentration in Maintenance Phase||Pre-dose at Weeks 2, 6, 10, 14, 22, 30 and 60|Participants from FAS, who were randomized and received at least one dose of the study drug in the maintenance phase for whom sample was available for PK analysis. Number analyzed is the number of participants with evaluable data at the given time-point.|||μg/mL||Standard Deviation|Mean
2611781|NCT02039505|Secondary|Serum Vedolizumab Concentration in Induction Phase||Pre-dose at Weeks 2, 6, 10 and 14|Participants from FAS, who received at least one dose of study drug in induction phase for whom sample was available for pharmacokinetic (PK) analysis. Number analyzed is the number of participants with evaluable data at the given time-point.|||μg/mL||Standard Deviation|Mean
2611782|NCT02039505|Secondary|Percentage of Participants With Corticosteroid-Free Remission at Week 60 in Maintenance Phase|Clinical Remission is defined as a complete Mayo score of ≤2 points and no individual subscore >1 point. Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission at Week 60. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).|Week 60|Participants from FAS included participants who were randomized and received at least one dose of the study drug in the maintenance phase and administered oral corticosteroids concomitantly at Week 0, were analyzed at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2611783|NCT02039505|Secondary|Percentage of Participants With Durable Remission in Maintenance Phase|Durable clinical remission is defined as complete Mayo score of ≤2 points and no individual subscore >1 point at both Weeks 10 and 60. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).|Weeks 10 and 60|FAS included participants who were randomized and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.|||percentage of participants||95% Confidence Interval|Number
2611784|NCT02039505|Secondary|Percentage of Participants With Mucosal Healing at Week 60 in Maintenance Phase|Mucosal healing is defined as a Mayo endoscopic subscore of ≤1 point. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Endoscopic findings were scored on a scale from 0 to 3 as follows: 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration).|Week 60|FAS included participants who were randomized and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.|||percentage of participants||95% Confidence Interval|Number
2611809|NCT02039219|Secondary|Changes in Activation of Innate Immunity|Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured.|Baseline to 180 days|Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured.||||||
2615129|NCT02004366|Secondary|Length of Hospital Stay|Length of hospital stay (ONLY for inpatient arms 1 and 2)|During Hospitalization|Length of hospital stay is applicable ONLY for inpatient arms (1 and 2)|||Days||Inter-Quartile Range|Median
2611785|NCT02039505|Secondary|Percentage of Participants With Durable Clinical Response in Maintenance Phase|Durable clinical response is defined as reduction in complete Mayo score of ≥3 points and ≥30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point at both Weeks 10 and 60. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).|Weeks 10 and 60|FAS included participants who were randomized and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.|||percentage of participants||95% Confidence Interval|Number
2611786|NCT02039505|Secondary|Percentage of Participants With Mucosal Healing at Week 10 in Induction Phase|Mucosal healing is defined as a Mayo endoscopic subscore of ≤1 point. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Endoscopic findings were scored on a scale from 0 to 3 as follows: 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration).|Week 10|FAS included participants who were randomized and received at least one dose of the study drug in the induction phase. The FAS in the induction phase does not include participants allocated in the Cohort 2 in the induction phase.|||percentage of participants||95% Confidence Interval|Number
2611787|NCT02039505|Secondary|Percentage of Participants With Clinical Remission at Week 10 in Induction Phase|Clinical Remission is defined as a complete Mayo score of ≤2 points and no individual subscore >1 point. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).|Week 10|FAS included participants who were randomized and received at least one dose of the study drug in the induction phase. The FAS in the induction phase does not include participants allocated in the Cohort 2 in the induction phase.|||percentage of participants||95% Confidence Interval|Number
2611788|NCT02039505|Primary|Number of Participants With Markedly Abnormal Laboratory Parameters Values|The laboratory values outside the range (Hemoglobin <=7 g/dL, Lymphocytes <500 /µL, WBC <2000 /µL, Platelets <7.5 10^4/µL, Neutrophils <1000 /µL, alanine aminotransferase (ALT) >3.0 U/L x upper limit of normal (ULN), aspartate aminotransferase (AST) >3.0 U/L x ULN, Total Bilirubin >2.0 mg/dL x ULN, Amylase >2.0 (U/L) x ULN were considered markedly abnormal. Only laboratory parameters with events were represented.|From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)|Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.|||Participants|||Count of Participants
2611789|NCT02039505|Primary|Number of Participants With TEAE Related to Electrocardiogram (ECG)||From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)|Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.|||Participants|||Count of Participants
2611790|NCT02039505|Primary|Number of Participants With TEAE Related to Vital Signs|Vital signs included body temperature (axilla), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).|From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)|Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.|||Participants|||Count of Participants
2611791|NCT02039505|Primary|Number of Participants With TEAE Related to Body Weight||From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)|Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.|||Participants|||Count of Participants
2611792|NCT02039505|Primary|Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)|Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.|||Participants|||Count of Participants
2611793|NCT02039505|Primary|Percentage of Participants With Clinical Remission at Week 60 in Maintenance Phase|Clinical Remission is defined as a complete Mayo score of ≤2 points and no individual subscore >1 point. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).|Week 60|FAS included participants who were randomized and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.|||percentage of participants||95% Confidence Interval|Number
2611838|NCT02038946|Secondary|Progression Free Survival (PFS) Based on IRRC Assessment|PFS was summarized descriptively using the Kaplan-Meier (KM) product-limit method. Median values of PFS, along with the two-sided 95% CIs were calculated using a method based on log-log transformation.|From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)|All treated participants|||months||95% Confidence Interval|Median
2611794|NCT02039505|Primary|Percentage of Participants With a Clinical Response at Week 10 in Induction Phase|Clinical response is defined as a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores (rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment), a global assessment by the physician, and an endoscopic subscore. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).|Week 10|Full analysis set (FAS) included participants who were randomized and received at least one dose of the study drug in the induction phase. The FAS in the induction phase does not include participants allocated in the Cohort 2 in the induction phase.|||percentage of participants||95% Confidence Interval|Number
2611795|NCT02039427|Other Pre-specified|Potential Side Effects Associated With the Study Drugs|Potential side effects associated with the study drugs, such as anlgesic use, nausea and vomiting.|at 1, 6 and 24 hours after extubation||||Participants|||Count of Participants
2611796|NCT02039427|Secondary|The Incidence of Postoperative Hoarseness(PH) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy|"The investigator asked scales to patients at 1, 6 and 24h after extubation. PH was assessed using a 4-grade scale (0-3): 0, none; 1, mild (noticed by the patient only); 2, severe (obvious to observer); 3 aphonia (silence of voice)~● Incidence of hoarseness: If patient exhibit hoarseness scale more than 1, investigator will record as positive sign"|at 1, 6 and 24 hours after thyroidectomy||||Participants|||Count of Participants
2611797|NCT02039427|Primary|The Incidence of Postoperative Sore Throat(POST) Using Ketorolac and Dexamethasone in Womend After Thyroidectomy|"The investigator asked scales to patients at 1, 6 and 24h after extubation. POST was defined as discomfort at larynx or pharynx at rest and during swallowing after surgery and was assessed using a 4-grade scale (0-3) based on verbal responses to questions: 0, none; 1, mild (less severe than with a cold); 2, moderate (similar with a cold); 3 severe (more severe than with a cold)~● Incidence of sore throat : if patient rates sore throat scale more than 1, investigator will record as positive symptom."|at 1, 6 and 24 hours after thyroidectomy||||Participants|||Count of Participants
2611798|NCT02039414|Secondary|Maternal Lipid Oxidation|The investigators will measure maternal lipid oxidation rate using indirect calorimetry (True One 2400, Parvo Medics, Sandy, UT) before, during, and after acute exercise. This will involve placing a hoodlike device over the subject's head as they lay supine (rest).During exercise, this involved using a mouthpiece and noseclips. Using both techniques, The investigators will be able to calculate lipid oxidation rates from the volumes of CO2 produced and volumes of O2 used.The reported measure is lipid oxidation rate during exercise. The equation used to calculate lipid oxidation is: lipid oxidation (g/min) = 1.695 VO2- 1.701 VCO2 .|Visit 2 (32-37 weeks gestation)- reported lipid oxidation is the average of lipid oxidation over the course of the 30min exercise bout (i.e. data collected at minutes 8-10, minutes 18-20, and minutes 28-30 of exercise, all averaged together).|Of the 40 women consented, only 32 (16 per group) completed all study visits and have lipid oxidation data.|||g/min||Standard Deviation|Mean
2611799|NCT02039414|Secondary|Maternal Inflammation|High-Sensitivity C-reactive protein was measured.|This was taken while fasted and under resting conditions at the beginning of visit 2 (between 32 and 37 weeks gestation). This value was only measured at baseline (i.e. one timepoint).|Of the 40 women consented, only 32 (16 in each group, completed the study visits). Thus, these 32 have CRP data.|||mg/L||Standard Deviation|Mean
2611800|NCT02039414|Primary|Neonatal Insulin Resistance|Infant HOMA-IR will be determined by measuring umbilical cord plasma glucose and insulin concentrations at parturition vis cord blood collection. Cord blood will be collected within 30 min of delivery, centrifuged for 10 min at 3000rpm to remove plasma, and stored at -80.|Immediately after delivery|We could not obtain cord blood on all infants (thus, specimens were obtained fro 14 obese active and 12 obese inactive women). Due to medical emergencies or lack-of cord blood available, there were several instances where these specimens could not be obtained by the study team.|||HOMA_IR, unitless measure||Standard Deviation|Mean
2611801|NCT02039414|Primary|Neonatal Adiposity|Within 48 hours of delivery, neonatal body composition (% fat mass) will be measured by skin fold thickness measurement and by air displacement plethysmography (Pea Pod, Life Measurement, Inc., Concord, CA) in the CRU at WUSM.|24-48 hr after delivery|Several babies were not able to be measured for this part of the study- the primary reason being a weekend delivery that was discharged before measurements could be obtained by the study team. Our clinical research unit was not open on weekends to the the Peapod scans. This explains why there were only 15 babies per group for this outcome.|||% fat||Standard Deviation|Mean
2611802|NCT02039375|Secondary|Mortality at 90 Days||90 days||||Participants|||Count of Participants
2611803|NCT02039375|Secondary|Degree of Disability at 90 Days as Assessed by the mRS|"The mRS is a scale of disability with a score range from 0-6. 0-no symptoms, back to normal.~some symptoms, able to do all prior activities, does not need help from others.~some symptoms, unable to do all prior activities, does not need help from others.~needs help from others, able to walk.~needs help from other, unable to walk without help.~needs total care.~the patient has expired."|At 90 days||||score on a scale||Full Range|Median
2611804|NCT02039375|Secondary|Severity of Symptoms of Stroke at 90 Days as Assessed by the NIHSS|The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke.|At 90 days|The NIHSS assessment at 90 days was not done for 7 participants.|||score on a scale||Inter-Quartile Range|Median
2611805|NCT02039375|Secondary|Degree of Disability as Assessed by the Modified Rankin Score (mRS)|"The mRS is a scale of disability with a score range from 0-6. 0 - no symptoms, back to normal.~- some symptoms, able to do all prior activities, does not need help from others.~- some symptoms, unable to do all prior activities, does not need help from others.~- needs help from others, able to walk.~- needs help from other, unable to walk without help.~- needs total care.~- the patient has expired."|At the time of discharge from the hospital, up to 90 days||||score on a scale||Full Range|Median
2611806|NCT02039375|Secondary|Severity of Stroke at 24 Hours as Assessed by the National Institutes of Health Stroke Scale (NIHSS)|The NIHSS is a scale of stroke severity with 15 items and a score range from 0 to 42. 0 = no stroke; 1-4 = minor stroke; 5-15 = moderate stroke; 15-20 = moderate/severe stroke; 21-42 = severe stroke.|24 hours||||score on a scale||Inter-Quartile Range|Median
2611810|NCT02039219|Secondary|Changes in Cytokines|Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured.|Baseline to 180 days|Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured.||||||
2611811|NCT02039219|Secondary|Changes in Bacterial Translocation|Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured.|Baseline to 180 days|Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured.||||||
2611812|NCT02039219|Secondary|Length of Hospital Stays||Baseline to 180 days||||Days||Standard Deviation|Mean
2611813|NCT02039219|Secondary|Changes in Serum Oxidative Stress.|Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured.|Baseline to 180 days|Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured.||||||
2611814|NCT02039219|Secondary|Changes in Intestinal Inflammation|Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured.|Baseline to Day 180|Early termination of the study resulted in insufficient numbers of participants in each arm to allow meaningful assessment of obeticholic acid effects on these secondary outcomes. Therefore these endpoints were not measured and no statistical analysis for these endpoints was done as they endpoints were not measured.||||||
2611815|NCT02039219|Secondary|Rates of Hospitalization|Number of subjects with one or more hospitalization are reported in relation to study medication (not related, unlikely, possible, probable, definite).|Baseline to 180 days||||Events|||Number
2611816|NCT02039219|Secondary|Percentage of Participants Deceased at Day 42, 90 and 180|Number of subjects deceased at day 42, 90, and 180.|Days 42, 90 and 180||||percentage of mortality|||Number
2611817|NCT02039219|Secondary|Change in Child-Pugh Score at Day 42, 90 and 180 Days|The Child-Pugh score is a system for assessing the prognosis — including the required strength of treatment and necessity of liver transplant — of chronic liver disease, primarily cirrhosis. It provides a forecast of the increasing severity of your liver disease and your expected survival rate. The Child-Pugh score is determined by scoring five clinical measures of liver disease. A score of 1, 2, or 3 is given to each measure, with 3 being the most severe. The total Child-Pugh range is 5-15, with 15 being the most severe.|Days 42, 90 and 180||||units on a scale||Standard Deviation|Mean
2611818|NCT02039219|Secondary|Change in MELD Score at 90 and 180 Days|The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months.|Days 90 and 180||||units on a scale||Standard Deviation|Mean
2611819|NCT02039219|Secondary|Adverse Events (AEs) During the Treatment and Follow-up Phases|Number of subjects with one or more AEs are reported in relation to study medication (not related, unlikely, possible, probable, definite).|Baseline to 180 days||||Event|||Number
2611820|NCT02039219|Secondary|SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases|Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite).|Baseline to 180 days||||Events|||Number
2611821|NCT02039219|Secondary|Any SAEs During the Follow-up Phase|Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite).|Days 42 to 180||||Events|||Number
2611822|NCT02039219|Primary|MELD Score Change From Baseline Mean(SD)|The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months.|Baseline to 6 weeks (Day 42)||||units on a scale||Standard Deviation|Mean
2611823|NCT02039219|Primary|Incidence of Serious Adverse Events (SAEs) During the Treatment Phase|Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite).|Baseline to 6 weeks (Day 42)|Subjects with SAEs not related to OCA|||Events|||Number
2611824|NCT02039219|Primary|MELD Score Mean(SD)|The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months.|Baseline to 6 weeks (Day 42)|The decrease in MELD score from baseline to Day 42 was -3.4 in the OCA arm, and -2.2 in the placebo arm with an overall P-Value of 0.6170.|||units on a scale||Standard Deviation|Mean
2611825|NCT02039115|Primary|Stricture Formation|Primary outcome measure is the rate of symptomatic esophageal stricture formation.|98 weeks||||Participants|||Count of Participants
2611871|NCT02038907|Secondary|Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study|Withdrawal due to an AE will occur if the participant experiences an AE that requires early termination because continued participation imposes an unacceptable risk to the participant's health or the participants is unwilling to continue because of the AE.|Day 1 up to Day 56|Safety Analysis Set included all participants who received at least one dose of trial vaccine.|||percentage of participants|||Number
2611826|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 4|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part IV concerns motor complications. The scale ranges from 0 to 24 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 6 participants from the usual care arm and 9 participants from the virtual visits arm.|||units on a scale||Standard Error|Mean
2611827|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 3|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part III is retained as the motor examination. The scale ranges from 0 to 108 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 9 participants from the usual care arm and 9 participants from the virtual visits arm.|||units on a scale||Standard Error|Mean
2611828|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part 2|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part II concerns motor experiences of daily living. The scale ranges from 0 to 52 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 12 participants from the usual care arm and 7 participants from the virtual visits arm.|||units on a scale||Standard Error|Mean
2611829|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IB|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part I concerns nonmotor experiences of daily living. The scale ranges from 0 to 52 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 11 participants from the usual care arm and 7 participants from the virtual visits arm.|||units on a scale||Standard Error|Mean
2611830|NCT02038959|Secondary|Minutes Spend on Last Parkinson's Disease Provider Visit||One year|Data was not collected on 10 participants in the usual care arm and 28 participants in the virtual visits arm.|||minutes||Inter-Quartile Range|Median
2611831|NCT02038959|Secondary|Change in Patient Assessment of Chronic Illness Care|We will assess change in the perceived quality of care using the Patient Assessment of Chronic Illness Care (PACIC). Each scale is scored by averaging the items completed within that scale, and the overall PACIC is scored by averaging scores across all 20 items. The scale ranges from 1-5 with higher scores indicating better care by the health team.|baseline to one year|Data was not collected in 16 participants from the usual care arm and 12 participants from the virtual visits arm.|||units on a scale||Standard Error|Mean
2611832|NCT02038959|Secondary|Change in Parkinson Disease Rating Scale (MDS-UPDRS) Part IA|Parkinson disease clinical characteristics will be assessed by a physician independent rater, blinded to treatment group, at baseline and at the conclusion of the study, using the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS). Part I concerns nonmotor experiences of daily living. The scale ranges from 0 to 24 with higher numbers indicated more severe disease.|baseline to one year|Data was not collected in 6 participants from the usual care arm and 8 participants from the virtual visits arm.|||units on a scale||Standard Error|Mean
2611833|NCT02038959|Secondary|Change in Montreal Cognition Assessment|We will assess changes in cognition from baseline to the end of the study using the Montreal Cognitive Assessment (MoCA), administered remotely. The scale ranges from 0-30 with higher numbers indicating better cognition.|baseline to one year|Data was not collected on 6 participants in the usual care arm and 9 participants in the virtual visits arm.|||units on a scale||Standard Error|Mean
2611834|NCT02038959|Secondary|Change in EQ-5D Index Value|EuroQol five dimensions questionnaire (EQ-5D) is a standardized instrument for measuring generic health status. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale ranges from 11111 to 55555 with higher numbers indicating worse health status. The five-digit descriptors are converted to EQ-5D Index Values, which range from -0.109 (corresponding to 55555, the worst possible health) to 1.000 (corresponding to 11111, the best possible health).|baseline to one year|Data was not collected in 6 participants from the usual care arm and 9 participants from the virtual visits arm.|||units on a scale||Standard Error|Mean
2611835|NCT02038959|Primary|Change From Baseline in the Quality of Life Measured by Parkinson Disease Questionnaire 39|Assessed as the change in quality of life, measured by the Parkinson Disease Questionnaire 39 (PDQ-39). The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month. Assesses how often patients experience difficulties across the 8 quality of life dimensions. Assesses impact of Parkinson's Disease (PD) on specific dimensions of functioning and well-being. The score ranges from 0-100 with lower scores reflecting better quality of life.|Baseline to One year|Data was not collected on 17 participants in the usual care arm and 18 participants in the virtual visits arm.|||units on a scale||Standard Error|Mean
2611836|NCT02038959|Primary|Feasibility of Virtual Visits for Parkinson Disease|Feasibility of virtual visits will be determined by the number of participants who complete at least one virtual visit successfully.|One year||||participants|||Number
2611837|NCT02038946|Secondary|Overall Response Rate (ORR) Based on Investigator Assessments|"ORR is determined by investigator assessments according to the revised International Working Group Criteria for non-Hodgkin Lymphoma. ORR is defined as the number of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and is expressed as a percentage of all treated participants.~CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement.~PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. >=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)"|From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)|All treated participants|||Percentage of participants||95% Confidence Interval|Number
2615130|NCT02004366|Secondary|Daily Dose of Insulin|Total daily dose of insulin|Inpatient (average 5 days) and outpatient up to 12 weeks||||units/kg/day||Standard Deviation|Mean
2611839|NCT02038946|Secondary|Partial Remission (PR) Rate Based on IRRC Assessment|"PR rate is defined as the number of participants with a best overall response (BOR) of PR according to the 2007 International Working Group (IWG) criteria, based on IRRC assessment, divided by the number of treated participants and expressed as a percentage.~PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. >=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)"|From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)|All treated participants|||Percentage of participants||95% Confidence Interval|Number
2611840|NCT02038946|Secondary|Complete Remission Rate (CRR) Based on IRRC Assessment|"CRR is defined as the number of subjects with a BOR of CR according to the revised International Working Group Criteria for non-Hodgkin Lymphoma, divided by the number of treated participants and expressed as a percentage.~CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement."|From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)|All treated participants|||Percentage of participants||95% Confidence Interval|Number
2611841|NCT02038946|Secondary|Duration of Response (DOR) Based on IRRC Assessments|"DOR is defined as the time from first remission (CR or PR) to the date of initial objectively documented progression as determined using the revised International Working Group Criteria for non-Hodgkin Lymphoma, or death due to any cause, whichever occurs first.~CR definition includes the complete disappearance of all evidence of disease, the definition of PR includes at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir, as described in the IWG response criteria"|From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)|All treated participants|||months||95% Confidence Interval|Median
2611842|NCT02038946|Primary|Overall Response Rate (ORR) as Determined by IRRC|"ORR is determined by an independent radiologic review committee (IRRC) according to the revised International Working Group Criteria for non-Hodgkin Lymphoma. ORR is defined as the number of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and expressed as a percentage of all treated participants.~CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement.~PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. >=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)"|From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)|All treated participants|||Percentage of participants||95% Confidence Interval|Number
2611843|NCT02038933|Secondary|Objective Response Rate (ORR) Per Investigator Assessment|"ORR is defined as the number of subjects with a BOR of CR or PR, according to investigator assessment, divided by the number of treated subjects.~CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir."|From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to April 2016, approximately 25 months)|All treated participants|||Percentage of participants||95% Confidence Interval|Number
2611844|NCT02038933|Secondary|Progression Free Survival|PFS is defined as the time from first dosing date to the date of the first documented progression, as determined by an IRRC according to the 2007 revised IWG Criteria for Malignant Lymphoma, or death due to any cause, whichever occurs first.|From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (assessed up to April 2016, approximately 25 months)|All treated participants|||months||95% Confidence Interval|Median
2611845|NCT02038933|Secondary|Duration of Partial Remission|"Duration of PR is defined as the time from first documentation of PR to the date of initial objectively documented progression as determined using the 2007 IWG criteria, based on IRRC assessment, or death due to any cause, whichever occurs first.~CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir."|From date of first documentation of PR to date of disease progression or death due to any cause, whichever occurs first (assessed up to April 2016, approximately 25 months)|All participants with BOR of PR|||months||Full Range|Median
2611846|NCT02038933|Secondary|Rate of Partial Remission|"PR rate is defined as the number of subjects with a BOR of PR according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on IRRC assessment, divided by the number of treated subjects.~CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir."|From date of first dose to date of documentation of PR (assessed up to April 2016, approximately 25 months)|All treated participants|||Percent of participants with BOR of PR||95% Confidence Interval|Number
2611847|NCT02038933|Secondary|Duration of Complete Remission|"The duration of CR is defined as the time from first documentation of CR (the date of first negative FDG-PET scan or the date of first documentation of no disease involvement in the bone marrow [if required], whichever occurs later) to the date of initial objectively documented progression as determined using the 2007 IWG criteria, based on IRRC assessment, or death due to any cause, whichever occurs first.~CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir."|From time of first documentation of CR to the date of initial documented disease progression or death due to any cause, whichever occurs first (Assessed up to April 2016, approximately 25 months)|All participants with BOR of CR|||months||Full Range|Median
2611942|NCT02038790|Secondary|Percentage of Participant Response to the Question: If You Did Want to Abuse This Medication, Would You Prefer to......|"Choices to the question above are:~Crush and snort~Liquefy and inject~Not able to abuse this formulation"|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
2611848|NCT02038933|Secondary|Complete Remission Rate|Complete Remission Rate is defined as the number of subjects with a BOR of CR according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on IRRC assessment, divided by the number of treated subjects. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; SD= Failure to attain CR/PR or PD; PD= Any new lesion or increase by >=50% of previously involved sites from nadir.|From date of first dose to date of documented CR|All treated participants|||Percent of participants with BOR of CR||95% Confidence Interval|Number
2611849|NCT02038933|Secondary|Duration of Response (DOR)|DOR is defined as the time from first response (CR or PR) to the date of initial objectively documented progression as determined using the 2007 revised IWG Criteria for Malignant Lymphoma, based on IRRC assessment, or death due to any cause, whichever occurs first. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; SD= Failure to attain CR/PR or PD; PD= Any new lesion or increase by >=50% of previously involved sites from nadir.|From date of first response to the date of documented disease progression or death, whichever occurs first (assessed up to April 2016, approximately 25 months)|All participants with BOR of CR or PR|||months||95% Confidence Interval|Median
2611850|NCT02038933|Primary|Objective Response Rate (ORR) Per Independent Radiologic Review Committee (IRRC) Assessment|ORR is defined as the number of subjects with a Best Overall Response (BOR) of Complete Remission (CR) or Partial Remission (PR), according to the 2007 revised International Working Group (IWG) Criteria for Malignant Lymphoma, , based on IRRC assessment, divided by the number of treated subjects. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.|From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assessed up to April 2016, approximately 25 months)|All treated participants|||Percentage of participants||95% Confidence Interval|Number
2611851|NCT02038920|Secondary|Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Open Label Cohort||Weeks 0, 10, 30, 62, 94 and 16 weeks after the last dose of study drug in open-label cohort|Participants who underwent proper AVA test out of the 'FAS in Open Label Cohort', the participants who received at least one dose of study drug in the open label cohort were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point.|||Participants|||Count of Participants
2611852|NCT02038920|Secondary|Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Maintenance Phase||Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug in maintenance phase|Participants who underwent proper AVA test out of the 'FAS in Maintenance Phase', the participants who received at least one dose of study drug in the maintenance phase were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point.|||Participants|||Count of Participants
2611853|NCT02038920|Secondary|Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Induction Phase||Weeks 0, 10 and 16 weeks after the last dose of study drug in induction phase|Participants who underwent proper AVA test out of 'the FAS in the induction phase' were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point.|||Participants|||Count of Participants
2611854|NCT02038920|Secondary|Number of Participants With Anti-vedolizumab Antibodies (AVA) in Open Label Cohort||Weeks 0, 10, 30, 62, 94 and 16 weeks after the last dose of study drug in open-label cohort|Participants who underwent proper AVA test out of the 'FAS in Open Label Cohort', the participants who received at least one dose of study drug in the open label cohort were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point.|||Participants|||Count of Participants
2611855|NCT02038920|Secondary|Number of Participants With Anti-vedolizumab Antibodies (AVA) in Maintenance Phase||Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug in maintenance phase|Participants who underwent proper AVA test out of the 'FAS in Maintenance Phase', the participants who received at least one dose of study drug in the maintenance phase were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point.|||Participants|||Count of Participants
2611856|NCT02038920|Secondary|Number of Participants With Anti-vedolizumab Antibodies (AVA) in Induction Phase||Weeks 0, 10 and 16 weeks after the last dose of study drug in induction phase|Participants who underwent proper AVA test out of 'the FAS in the induction phase' were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point.|||Participants|||Count of Participants
2611857|NCT02038920|Secondary|Serum Vedolizumab Concentration in Maintenance Phase||Weeks 2, 6, 10, 14, 22, 30 and 60|Participants from 'FAS in Maintenance Phase', who were randomized and received at least one dose of the study drug in the maintenance phase and for whom samples were available for PK analysis. Number analyzed is the number of participants with evaluable data at the given time-point.|||ug/mL||Standard Deviation|Mean
2611858|NCT02038920|Secondary|Serum Vedolizumab Concentration in Induction Phase||Weeks 2, 6, 10 and 14|Participants from 'FAS in Induction Phase', who were randomized and received at least one dose of the study drug in the induction phase and for whom samples were available for pharmacokinetic (PK) analysis. Number analyzed is the number of participants with evaluable data at the given time-point.|||ug/mL||Standard Deviation|Mean
2611859|NCT02038920|Secondary|Maintenance Phase: Percentage of Participants With Corticosteroid-free Clinical Remission|Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 60. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.|Week 60|Participants from FAS in maintenance phase included participants who were randomized and received at least one dose of the study drug in the maintenance phase and administered oral corticosteroids concomitantly at Week 0, were analyzed at the given timepoint.|||percentage of participants||95% Confidence Interval|Number
2613113|NCT02025205|Primary|Percentage Change in Forced Expiratory Volume in 1 s (FEV1) (ITT Population)|Percentage change in FEV1 at 3 months relative to Baseline in the EBV group, compared to the SoC group.|At baseline and after 3 months|ITT population|||percent change||Standard Deviation|Mean
2611860|NCT02038920|Secondary|Maintenance Phase: Percentage of Participants With Durable Clinical Remission|Durable clinical remission is defined as participants with CDAI score ≤ 150 at both Weeks 14 and 60. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.|From Week 14 and Week 60|FAS in the maintenance phase included participants who were randomized and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.|||percentage of participants||95% Confidence Interval|Number
2611861|NCT02038920|Secondary|Maintenance Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response|A response to therapy is considered a decrease from baseline of at least 100 points in the CDAI score at Week 10. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.|Week 60|FAS in the maintenance phase included participants who were randomized and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.|||percentage of participants||95% Confidence Interval|Number
2611862|NCT02038920|Secondary|Induction Phase: Change From Baseline in C-reactive Protein (CRP) Values||Baseline to Week 10|Participants from 'FAS in the induction phase' with CRP value exceeding 0.30 mg/dL at Baseline were analyzed at given time point. Number analyzed is the number of participants with evaluable data at the given time-point.|||mg/dL||Standard Deviation|Mean
2611863|NCT02038920|Secondary|Induction Phase: Percentage of Participants With Clinical Remission|Clinical remission is defined as the CDAI score ≤150. CDAI is scoring system for the assessment of Crohn's disease activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.|Week 10|FAS in the induction phase included participants who were randomized and received at least one dose of the study drug in induction phase.|||percentage of participants||95% Confidence Interval|Number
2611864|NCT02038920|Primary|Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values|The laboratory values outside the range (Hemoglobin <=7 g/dL, Lymphocytes <500 /microL, White Blood Cell (WBC) <2000 /microL, Platelets <7.5 10^4/microL, Neutrophils <1000 /microL, Alanine Aminotransferase (ALT) (Glutamic Pyruvic Transaminase; GPT) >3.0 U/L x upper limit of normal (ULN), Aspartate Aminotransferase (AST) (Glutamic Oxaloacetic Transaminase; GOT) >3.0 U/L x ULN, Total Bilirubin >2.0 mg/dL x ULN, Amylase >2.0 (U/L) x ULN are considered markedly abnormal.|From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)|Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.|||Participants|||Count of Participants
2611865|NCT02038920|Primary|Number of Participants With TEAE Related to Electrocardiogram (ECG) [Bundle Branch Block Right]|"Reported events on this outcome measure were Bundle Branch Block Right."|From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)|Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.|||Participants|||Count of Participants
2611866|NCT02038920|Primary|Number of Participants With TEAE Related to Vital Signs|"Vital signs included body temperature (axilla), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm). Reported events on this outcome measure were Pyrexia, Body temperature increased, Hypertension, and Orthostatic hypotension."|From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)|Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.|||Participants|||Count of Participants
2611867|NCT02038920|Primary|Number of Participants With TEAE Related to Body Weight (Weight Decreased)|"Reported events on this outcome measure were Weight Decreased."|From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)|Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.|||Participants|||Count of Participants
2611868|NCT02038920|Primary|Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs)|An Adverse event (AE) is defined as any untoward medical occurrence in a study participant who received a drug (including a study drug); it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)|Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.|||Participants|||Count of Participants
2611869|NCT02038920|Primary|Maintenance Phase: Percentage of Participants With Clinical Remission|Clinical remission is defined as the CDAI score ≤150. CDAI is scoring system for the assessment of Crohn's disease activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.|Week 60|FAS in the maintenance phase included participants who were randomized and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.|||percentage of participants||95% Confidence Interval|Number
2611870|NCT02038920|Primary|Induction Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response|A response to therapy is considered a decrease from baseline of at least 100 points in the CDAI score at Week 10. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.|Week 10|Full analysis set (FAS) in the induction phase included participants who were randomized and received at least one dose of the study drug in induction phase.|||percentage of participants||95% Confidence Interval|Number
2611872|NCT02038907|Secondary|Percentage of Participants With Significant New Medical Conditions|"Significant new medical conditions will be evaluated by the investigator for the co-existence of any of the following conditions: Adverse events of special interest (AESIs) are predefined events for potential immune mediated disorders. All AESIs are medically evaluated to assess if they might indicate an immune-mediated disorder.~Immune mediated events (IMEs) are AEs that represent a new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment."|Day 1 up to Day 56|Safety Analysis Set included all participants who received at least one dose of trial vaccine.|||percentage of participants|||Number
2611873|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.4.2012 EC50 (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GII.4.2012 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only.~D=Day"|Day 1 (Baseline) and Day 56|Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.|||titer||Standard Deviation|Geometric Mean
2611874|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GI.3 EC50 (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GI.3 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only.~D=Day"|Day 1 (Baseline) and Day 56|Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.|||titer||Standard Deviation|Geometric Mean
2611875|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.2 EC50 (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GII.2 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only.~D=Day"|Day 1 (Baseline) and Day 56|Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.|||titer||Standard Deviation|Geometric Mean
2611876|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)|"Blocking Titers 50 (BT50) of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
2611877|NCT02038907|Secondary|Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
2611878|NCT02038907|Secondary|GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection Assays|"GMFR of anti-norovirus Cross-Protection Assays: GII.2 EC50, GI.3 EC50 and GII.4.2012 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only.~D=Day"|Day 56|Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.|||titer||Standard Deviation|Geometric Mean
2611879|NCT02038907|Secondary|GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)|"GMFR of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
2611880|NCT02038907|Secondary|GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)|"GMFR of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
2611881|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)|"Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA binding assay.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
2611882|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)|"Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
2611883|NCT02038907|Secondary|Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
2611884|NCT02038907|Secondary|Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)|"Blocking titers 50 (BT50) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.~D=Day"|Baseline (Day 1) and Days 28, 56, 208 and 393|"Full Analysis Set included all participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
2612136|NCT02037165|Secondary|"Single Central P2-component Amplitudes - Measured in UVB-irradiated Skin Type"|"Single central P2-component amplitudes - measured in UVB-irradiated skin type."|up to 24 hours(h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])|PDS|||µv||Standard Deviation|Mean
2611885|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)|"The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by HBGA binding assay.~D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of study drug and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||percentage of participants||95% Confidence Interval|Number
2611886|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)|"The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by HBGA binding assay.~D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of study drug and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||percentage of participants||95% Confidence Interval|Number
2611887|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)|"Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by histoblood group antigen (HBGA) binding assay.~D=Day"|Baseline and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."|||percentage of participants||95% Confidence Interval|Number
2611888|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)|"Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||ratio||Standard Deviation|Geometric Mean
2611889|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)|"Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||ratio||Standard Deviation|Geometric Mean
2611890|NCT02038907|Secondary|Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)|"Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
2611891|NCT02038907|Secondary|Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)|"Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
2611892|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)|"The percentage of participants with a 4-fold rise from or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||percentage of participants||95% Confidence Interval|Number
2611893|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)|"The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||percentage of participants||95% Confidence Interval|Number
2611894|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)|"Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393.~D=Day"|Baseline and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."|||percentage of participants||95% Confidence Interval|Number
2611895|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)|"Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||ratio||Standard Deviation|Geometric Mean
2611896|NCT02038907|Secondary|Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)|"Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA.~D=Day"|Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||ratio||Standard Deviation|Geometric Mean
2611897|NCT02038907|Secondary|Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)|"Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
2611898|NCT02038907|Secondary|Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)|"Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA.~D=Day"|Day 1 (Baseline) and Days 28, 56, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."|||titer||Standard Deviation|Geometric Mean
2611899|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)|"The percentage of participants with a 4-fold rise or greater from in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).~D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||percentage of participants||95% Confidence Interval|Number
2611900|NCT02038907|Secondary|Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)|"The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).~D=Day"|Baseline and Days 28, 56, 208 and 393|"Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. n in the category is the number of participants with data available at the given time-point."|||percentage of participants||95% Confidence Interval|Number
2611901|NCT02038907|Secondary|Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)|"Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).~D=Day"|Baseline and Days 28, 208 and 393|"Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. n in the category is the number of participants with data available at the given time-point."|||percentage of participants||95% Confidence Interval|Number
2611902|NCT02038907|Primary|Percentage of Participants With Serious Adverse Events (SAEs)|A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|Day 1 up to Day 393|Safety population included all participants who received at least one dose of trial vaccine.|||percentage of participants|||Number
2611903|NCT02038907|Primary|Percentage of Participants With Unsolicited Adverse Events (AEs)|Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.|Day 1 up to Day 56|Safety population included all participants who received at least one dose of trial vaccine.|||percentage of participants|||Number
2611904|NCT02038907|Primary|Oral Body Temperature Within 7 Days After Dose 2|Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site.|Days 28 through 34|Safety population included all participants who received at least one dose of trial vaccine.|||degrees Celsius||Standard Deviation|Mean
2611905|NCT02038907|Primary|Oral Body Temperature Within 7 Days After Dose 1|Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site.|Days 1 through 7|Safety population included all participants who received at least one dose of trial vaccine.|||degrees Celsius||Standard Deviation|Mean
2611906|NCT02038907|Primary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2|Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.|Days 28 through 34|Safety population included all participants who received at least one dose of trial vaccine.|||percentage of participants|||Number
2611907|NCT02038907|Primary|Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1|Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.|Days 1 through 7|Safety population included all participants who received at least one dose of trial vaccine.|||percentage of participants|||Number
2611908|NCT02038907|Primary|Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.|Days 28 through 34|Safety population included all participants who received at least one dose of trial vaccine.|||percentage of participants|||Number
2611909|NCT02038907|Primary|Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1|Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.|Days 1 through 7|Safety population included all participants who received at least one dose of trial vaccine.|||percentage of participants|||Number
2611910|NCT02038907|Primary|Percentage of Participants With a Seroresponse (Pan-Ig ELISA)|Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).|Baseline and Day 56|Full Analysis Set included all randomized participants who received at least one dose of trial vaccine.|||percentage of participants||95% Confidence Interval|Number
2612137|NCT02037165|Secondary|"Single Peripheral N2-component Amplitudes - Measured in Capsaicin-irritated Skin Type"|"Single peripheral N2-component amplitudes - measured in capsaicin-irritated skin type."|up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])|PDS|||µv||Standard Deviation|Mean
2611911|NCT02038881|Secondary|Percentage of Participants With Seroconversion by PRNT During Follow-up|SC rate based on PRNT. SC is defined as the appearance of antibody titers >= detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)|Per-protocol Set|||percentage of subjects||95% Confidence Interval|Number
2611912|NCT02038881|Secondary|Percentage of Participants With Seroconversion by PRNT 2 Weeks Following the Last Vaccination|SC rate based on PRNT. SC is defined as the appearance of antibody titers >= detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|Week 6 (Groups 1 and 2), Week 14 (Group 3)|Per-protocol Set|||percentage of subjects||95% Confidence Interval|Number
2611913|NCT02038881|Secondary|Percentage of Participants With Seroconversion by PRNT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))|SC rate based on PRNT. SC is defined as the appearance of antibody titers >= detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|Week 6|Per-protocol Set|||percentage of subjects||95% Confidence Interval|Number
2611914|NCT02038881|Secondary|Percentage of Participants With Seroconversion by PRNT|SC rate based on PRNT. SC is defined as the appearance of antibody titers >= detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|within 64 weeks|Per-protocol Set|||percentage of subjects||95% Confidence Interval|Number
2611915|NCT02038881|Secondary|Percentage of Participants With Seroconversion by ELISA During Follow-up|SC rate based on ELISA. SC is defined as the appearance of antibody titers >= detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)|Per-protocol Set|||percentage of subjects||95% Confidence Interval|Number
2611916|NCT02038881|Secondary|Percentage of Participants With Seroconversion by ELISA 2 Weeks Following the Last Vaccination|SC rate based on ELISA. SC is defined as the appearance of antibody titers >= detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|Week 6 (Groups 1 and 2), Week 14 (Group 3)|Per-protocol Set|||percentage of subjects||95% Confidence Interval|Number
2611917|NCT02038881|Secondary|Percentage of Participants With Seroconversion by ELISA 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))|SC rate based on ELISA. SC is defined as the appearance of antibody titers >= detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|Week 6|Per-protocol Set|||percentage of subjects||95% Confidence Interval|Number
2611918|NCT02038881|Secondary|Percentage of Participants With Seroconversion by ELISA|SC rate based on ELISA. SC is defined as the appearance of antibody titers >= detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.|within 64 weeks|Per-protocol Set|||percentage of subjects||95% Confidence Interval|Number
2611919|NCT02038881|Secondary|PRNT GMT During Follow-up|GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'. Participants discontinued prior to the follow-up visits are excluded.|Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)|Per-protocol Set|||Titer||95% Confidence Interval|Geometric Mean
2611920|NCT02038881|Secondary|PRNT GMT 2 Weeks Following the Last Vaccination|GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.|Week 6 (Groups 1 and 2), Week 14 (Group 3)|Per-protocol Set|||Titer||95% Confidence Interval|Geometric Mean
2611921|NCT02038881|Secondary|PRNT GMT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))|GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.|Week 6|Per-protocol Set|||Titer||95% Confidence Interval|Geometric Mean
2611922|NCT02038881|Secondary|GMTs Measured by Plaque Reduction Neutralization Test (PRNT) at All Immunogenicity Sampling Points|GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.|within 64 weeks|Per-protocol Set|||Titer||95% Confidence Interval|Geometric Mean
2611923|NCT02038881|Secondary|ELISA GMT During Follow-up|GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'. Participants discontinued prior to the follow-up visits are excluded.|Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)|Per-protocol Set|||Titer||95% Confidence Interval|Geometric Mean
2611924|NCT02038881|Secondary|ELISA GMT 2 Weeks Following the Last Vaccination|GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.|Week 6 (Groups 1 and 2), Week 14 (Group 3)|Per-protocol Set|||Titer||95% Confidence Interval|Geometric Mean
2611925|NCT02038881|Secondary|ELISA GMT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))|GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.|Week 6|Per-protocol Set|||Titer||95% Confidence Interval|Geometric Mean
2611926|NCT02038881|Secondary|Geometric Mean Titers (GMT) Measured by Enzyme-linked Immunosorbent Assay (ELISA) at All Immunogenicity Sampling Points|GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.|within 64 weeks|Per-protocol Set|||Titer||95% Confidence Interval|Geometric Mean
2611927|NCT02038881|Secondary|CD4+ T Cell Counts|Mean CD4+ T-cell counts over time|within 15 days after each vaccination|Full Analysis Set|||CD4 count (cells/µL)||Standard Deviation|Mean
2612138|NCT02037165|Secondary|"Single Peripheral N2-component Amplitudes - Measured in UVB-irradiated Skin Type"|"Single peripheral N2-component amplitudes - measured in UVB-irradiated skin type."|up to 24 hours(h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])|PDS|||µv||Standard Deviation|Mean
2611928|NCT02038881|Secondary|Number of Participants With Solicited General AEs|Number of Participants with solicited systemic/general AEs (pyrexia, headache, myalgia, nausea, fatigue, and chills) by intensity. Percentages based on subjects with at least one completed diary card. [Body temperature: 0 = <99.5 F (<37.5 C), 1 = ≥99.5 - <100.4 F (≥37.5 - <38.0 C), 2= ≥100.4 - <102.2 F (≥38.0 - <39.0 C), 3= ≥102.2 - <104.0 F (≥39.0 - <40.0 C), 4= ≥ 104.0 F (≥40.0 C); pyrexia is defined as oral temperature ≥ 100.4 F (≥ 38.0 C).] [Headache, myalgia, nausea, chills and fatigue: 0 = none, 1 = mild: easily tolerated, minimal discomfort and no interference with daily activity, 2 = moderate: some interference with daily activity, 3 = severe: prevents daily activity.]|within 8 days after any vaccination|Full Analysis Set|||Participants|||Count of Participants
2611929|NCT02038881|Secondary|Number of Participants With Solicited Local Adverse Events|Number of participants with solicited local AEs (redness, swelling, induration, pruritus, and pain) by intensity. Percentages based on subjects with at least one completed diary card. [Injection site erythema, injection site swelling and injection site induration--all sizes measured in diameter with max severity of: 0=0, 1 = <30 mm, 2 = ≥30 - <100 mm, 3 = ≥100 mm. Injection site pruritus: 0=absent, 1=mild, 2=moderate, 3=severe. Injection site pain: 0=absent, 1=painful to touch, 2=painful when limb is moved, 3=spontaneously painful/prevents normal activity.]|within 8 days after any vaccination|Full Analysis Set|||Participants|||Count of Participants
2611930|NCT02038881|Secondary|Number of Unsolicited Non-serious Adverse Events: Intensity|Occurrence of unsolicited non-serious AEs by Intensity|within 29 days after any vaccination|Full Analysis Set|||events|||Number
2611931|NCT02038881|Secondary|Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination|Occurrence of unsolicited non-serious AEs by relationship to study vaccine|within 29 days after any vaccination|Full Analysis Set|||events|||Number
2611932|NCT02038881|Secondary|Number of Participants With Related Grade >=3 Adverse Events|Number of Participants with any Grade >=3 Adverse Event probably, possibly, or definitely related to the study vaccine. Pooled solicited and unsolicited AEs.|within 29 days after any vaccination|Full Analysis Set|||Participants|||Count of Participants
2611933|NCT02038881|Secondary|Number of Participants With AESIs|Occurrence, relationship to the trial vaccine, and intensity of any adverse event of special interest (AESI)|within 75 weeks|Full Analysis Set|||Participants|||Count of Participants
2611934|NCT02038881|Primary|Number of Participants With SAEs|Occurrence, relationship and intensity of any serious AE (SAE)|within 75 weeks|Full Analysis Set|||Participants|||Count of Participants
2611935|NCT02038829|Secondary|Percentage of Subjects With Treatment-emergent Adverse Events (Overall and by Treatment)|A treatment emergent adverse event (TEAE) is any TEAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any TEAE with both a missing start and stop date.|Over 7 days|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||percentage of participants|||Number
2611936|NCT02038829|Secondary|Number of Subjects With Treatment-emergent Adverse Events (Overall and by Treatment)|A treatment emergent adverse event (TEAE) is any TEAE that occurred on or after the first dose of study medication, any SAE with a missing start date and a stop date on or after the first dose of study medication, or any TEAE with both a missing start and stop date.|Over 7 days|Safety population was defined as all subjects who were randomized to treatment and received at least one dose of study medication.|||participants|||Number
2611937|NCT02038829|Secondary|Standardized Change From Baseline in FEV1 AUC(0-12hours)|The standardized FEV1 AUC(0-12) on Day 7 was calculated using the trapezoidal rule from the changes in FEV1 from the baseline value (the mean of the two FEV1 values at 45 minutes and 15 minutes prior to morning dose at Day 1 of the respective Treatment Periods) and dividing by the actual length of the time interval).|Day 7|Efficacy Population: all subjects who were randomized to treatment, received at least one dose of study medication, and had at least one trough FEV1 evaluation and the corresponding baseline FEV1 for at least one treatment period.|||Liters||Standard Error|Least Squares Mean
2611938|NCT02038829|Primary|Change From Baseline in Trough FEV1 at Treatment Visit Day 7 Compared to Placebo.|Spirometry was performed according to internationally accepted standards. Trough FEV1 was defined as the average of the 2 spirometry values collected at 23 hours 15 minutes, and 23 hours 45 minutes post-morning dose on Day 7 of each Treatment Period. The FEV1 values within 6 hours after the use of rescue medication were considered as missing. Baseline was calculated as the mean of the FEV1 values at 45 minutes and 15 minutes prior to the morning dose at Day 1 of each Treatment Period|Baseline and Day 7|Efficacy Population: all subjects who were randomized to treatment, received at least one dose of study medication, and had at least one trough FEV1 evaluation and the corresponding baseline FEV1 for at least one treatment period.|||liters||Standard Error|Least Squares Mean
2611939|NCT02038790|Secondary|Change From Baseline in Subject Opiate Withdrawal Scale (SOWS)|"Participants completed the Subject Opiate Withdrawal Scale (SOWS) at baseline, and the end of each day of treatment.~SOWS is a validated scale when used as defined. The research site did not use SOWS as defined. The sponsor made the decision to not report this data since it was not captured in a validated format."|Day 0 prior to dosing, end of Day 0 (post dose), end of Day 1 (post dose)|Per protocol set.||||||
2611940|NCT02038790|Secondary|Dissolution Time of Intervention as Recorded by a Trained Observer|The subject was observed and times documented for time of administration and time dissolution (recorded in minutes and seconds) was completed by designated qualified study personnel at the site.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||minutes||Standard Deviation|Mean
2611941|NCT02038790|Secondary|Percentage of Participant Response to the Question: Compared to the Medication That You Are Currently Using for Treatment of Opioid Dependence, The Study Medication You Just Used Was.....|"Choices to the question above are:~More effective as a treatment for opioid dependence~Equally effective as a treatment for opioid dependence~Less effective as a treatment for opioid dependence~The same medication that I normally use"|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
2612139|NCT02037165|Secondary|Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of (LEP) in Capsaicin-irritated Skin|Overall Peak-to-Peak (PtP) N2/P2-component amplitude of (LEP) in capsaicin-irritated skin.|up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])|PDS|||µv||Standard Deviation|Mean
2611943|NCT02038790|Secondary|Percentage of Participant Response to the Request: When Thinking About the Medication You Used Today, Indicate on the Line Below Your Ability to Abuse This Medication|Participant responses were captured on a 10-point scale with 0 = No desire to abuse and 9= Extremely high desire to abuse.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
2611944|NCT02038790|Secondary|Percentage of Participant Response to the Request: Please Rate the Medication You Received Today in Terms of the Drug's Ability to Product a 'High'|Participant responses were captured on a 10-point scale with 0 = No high and 9= Extremely strong high.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
2611945|NCT02038790|Secondary|Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Skin Irritation or Blisters?|Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
2611946|NCT02038790|Secondary|Percentage of Participant Response to the Question: Did You Experience Any Uncomfortable Effects of Burning or Stinging?|Participant responses were captured on a 10-point scale with 0 = None and 9= Extreme.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
2611947|NCT02038790|Secondary|Percentage of Participant Favorable and Unfavorable Response to the Question: How Easily Did the Medication Dissolve in Your Mouth?|Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
2611948|NCT02038790|Secondary|Percentage of Participant Favorable and Unfavorable Response to the Question: How Comfortable Did It Feel In Your Mouth?|Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
2611949|NCT02038790|Secondary|Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Were the Package Instructions to Follow?|Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
2611950|NCT02038790|Secondary|Percentage of Participant Favorable and Unfavorable Response to the Question: How Easy or Difficult Was it to Open the Package?|Responses were captured on a 5-point scale with the 5 representing the most favorable response, 3 representing a neutral response and 1 representing a negative response. 'Favorable' responses include assessments 5 and 4, while 'Unfavorable' responses include assessments 3, 2 and 1.|Days 0-1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
2611951|NCT02038790|Secondary|Participant Assessments With Regard to Ease of Dissolution of Interventions|At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: Which one did you think dissolve easier in your mouth?|Day 1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
2611952|NCT02038790|Secondary|Participant Preference With Regard to Overall Taste of Interventions|At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: Which one did you prefer in regards to overall taste?|Day 1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
2611953|NCT02038790|Primary|Overall Intervention Preference As Assessed by Participants|At the conclusion of Study Day 1, participants completed a study exit product comparison questionnaire. This outcome summarizes the percentage of participant answers to the question: When thinking about the two medications you evaluated over the last two days, which medication type did you prefer?|Day 1|The per-protocol population included participants who did not miss any visit and had no major protocol violations.|||percentage of participants|||Number
2611954|NCT02038764|Secondary|Accumulation Ratio (Rac) on Day 71|Accumulation ratio was calculated from AUCinf at last dose/AUCinf at first dose, where AUCinf is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). On Day 71, 3 participants in cohort 1 had reportable Rac values.|0, 1, 4, hours post-dose on Day 71|All participants randomized and treated who had at least 1 of the PK parameters of interest were analyzed. On Day 71, 3 participants in cohort 1 had reportable Rac values.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2611955|NCT02038764|Secondary|Apparent Volume of Distribution (Vz/F) on Day 71|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. On Day 71, 1 participant in cohort 1, 5 participants in cohort 2, and 7 participants in cohort 3 had reportable Vz/F values|0, 1, 4 hours post-dose on Day 71|All participants randomized and treated who had at least 1 of the PK parameters of interest were analyzed. On Day 71, 1 participant in cohort 1, 5 participants in cohort 2, and 7 participants in cohort 3 had reportable Vz/F values|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
2612224|NCT02035475|Primary|Incidence of Lymphoceles|Identify whether the use of the Vessel Sealer for PLND reduces the incidence of screening detected lymphoceles via CT scan of the pelvis by comparing the Vessel Sealer side of the pelvis with the control side of the pelvis.|4 months|Lymphoceles were identified by CT scan at 3 months post surgery.|||participants|||Number
2611956|NCT02038764|Secondary|Plasma Decay Half-Life (t1/2) on Day 71|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. On Day 71, 2 participants in cohort 1, 5 participants in cohort 2, and 7 participants in cohort 3 had reportable values for t1/2|0, 1, 4 hours post-dose on Day 71|All participants randomized and treated who had at least 1 of the PK parameters of interest were analyzed. On Day 71, 2 participants in cohort 1 , 5 participants in cohort 2, and 7 participants in cohort 3 had reportable values for t1/2|||hr||Standard Deviation|Mean
2611957|NCT02038764|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 and Day 71|Time to reach maximum observed plasma concentration was observed directly from data as time of first occurrence on Day 1 and Day 71. On Day 71, 2 participants in cohort 4 had reportable Tmax values|0, 1, 4 hours post-dose on Day 1 and Day 71|All participants randomized and treated who had at least 1 of the PK parameters of interest were analyzed.On Day 71, 2 participants in cohort 4 had reportable Tmax values|||hr||Full Range|Median
2611958|NCT02038764|Secondary|Maximum Observed Plasma Concentration (Cmax) on Day 1 and Day 71|Maximum serum concentration was observed directly from data on Day 1 and Day 71. On Day 71, 2 participants in cohort 4 had reportable Cmax values|0, 1, 4 hours post-dose on Day 1 and Day 71|All enrolled participants treated who had at least 1 concentration value. On Day 71, 2 participants in cohort 4 had reportable Cmax values|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2611959|NCT02038764|Secondary|Apparent Oral Clearance (CL/F) on Day 71|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. On Day 71, 6 participants in cohort 1 had reportable CL/F values|0,1,4 hours post-dose on Day 71|All participants randomized and treated who had at least 1 of the PK parameters of interest were analyzed. Day 71, 6 participants in cohort 1 had reportable CL/F values|||mL/hr/kg||Geometric Coefficient of Variation|Geometric Mean
2611960|NCT02038764|Secondary|Area Under Concentration-Time Curve From Time Zero to Time Tau(AUCtau) on Day 1 and Day 71|Area under the concentration-time profile from time 0 to time tau (τ), the dosing interval, where tau = 168 hours for once a week dosing; tau = 336 hours for once every 2 weeks dosing. On Day 1, 3 participants in cohort 1 had reportable AUCtau values. On Day 71, 6 participants in cohort 1 and 2 participants in cohort 4 had reportable AUCtau values|0,1,4 hours post-dose on Day 1 and Day 71|All participants randomized and treated who had at least 1 of the PK parameters of interest were analyzed. On Day 1, 3 participants in cohort 1 had reportable AUCtau values. On Day 71, 6 participants in cohort 1 and 2 participants in cohort 4 had reportable AUCtau values|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2611961|NCT02038764|Primary|Number of Participants With Serum Anti-PF-06342674 Antibody Response Listed by Visit|Number of participants with serum anti-PF-06342674 antibody response to the intramuscular tetanus vaccine was reported. Positive Anti-PF-06342674 Antibody response is defined as anti-tetanus toxoid immunoglobulin G (IgG) titer value >=100|Day 1, Day 15, Day 29, Day 57, Day 85, and Day127 and follow-up visits|All participants who received at least 1 dose of study medication.|||participants|||Number
2611962|NCT02038764|Primary|Number of Participants With Electrocardiogram(ECG) Data That Met the Criteria for Potential Clinical Concern(Increases From Baseline)|Number of participants with ECG meeting the following criteria was reported: Criterion A: maximum PR interval increase from baseline percentage change (PctChg)>= 25/50%; Criterion B: maximum QRS complex increase from baseline PctChg >= 25/50%; Criterion C: maximum QTcF interval increase from baseline 30<=change<60 msec; Criterion D: maximum QTcF interval increase from baseline change >=60 msec.|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
2611963|NCT02038764|Primary|Number of Participants With Electrocardiogram(ECG) Data That Met the Criteria for Potential Clinical Concern(Absolute Value)|The number of participants with ECG absolute values meeting the following criteria was reported: Criterion A: maximum PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization) >=300 msec; Criterion B: maximum QRS complex(time from Q wave to the end of S wave, corresponding to ventricle depolarization) >=200 msec; Criterion C: maximum QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia's formula) 450-<480 msec; Criterion D: maximum QTcF interval 480-<500 msec; Criterion E: maximum QTcF interval (Fridericia's correction) >=500 msec|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
2611964|NCT02038764|Primary|Number of Participants With Vital Signs That Met the Criteria for Potential Clinical Concern(Increases From Baseline)|The number of participants with vital signs data of maximum increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in systolic BP >= 30 mmHg; Criterion B: maximum increase from baseline in diastolic BP >= 20 mmHg|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
2611965|NCT02038764|Primary|Number of Participants With Vital Signs That Met the Criteria for Potential Clinical Concern(Decreases From Baseline)|The number of participants with vital signs data of maximum decrease from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in systolic BP >= 30 mmHg; Criterion B: maximum decrease from baseline in diastolic BP >=20 mmHg|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
2611966|NCT02038764|Primary|Number of Participants With Vital Signs That Met the Criteria for Potential Clinical Concern(Absolute Values)|Number of participants with vital signs data of absolute values meeting criteria of potential clinical concern. Absolute values were analyzed for systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse rate. Number of participants with vital signs data meeting the following criteria was reported: Criterion A: SBP <90 millimeter of mercury(mmHg); Criterion B: DBP <50 mmHg; Criterion C: pulse rate < 40 beats per minute(BPM); Criterion D: pulse rate >120 BPM|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
2612489|NCT02033005|Primary|Change in Total Adipose Tissue Volume|Difference in total adipose tissue volume, measured using whole body magnetic resonance imaging.|Between birth and 6-12 weeks age|Reduced participant number for this analysis represents missing data for some infants at one scan point|||Litres||Inter-Quartile Range|Median
2611967|NCT02038764|Primary|Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)|The following laboratory test parameters were evaluated in this study: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, absolute total neutrophils, absolute eosinophils, absolute basophils, absolute monocytes, and absolute lymphocytes),coagulation (partial thromboplastin time, prothrombin, and prothrombin international ratio), liver function(total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein, and albumin), renal function (blood urea nitrogen, creatinine, and uric acid), electrolytes (sodium, potassium, chloride, calcium, and venous bicarbonate), clinical chemistry(glucose, glycosylated, and hemoglobin), and urinalysis (pH, qualitative glucose, qualitative protein, qualitative blood, urobilinogen, qualitative bilirubin, nitrites, leukocyte, esterase and microscopy).|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
2611968|NCT02038764|Primary|Number of Participants With All-Causality Treatment-Emergent Hypoglycemic Adverse Events Listed by CTCAE Grade|Any blood glucose values <55 mg/dL with or without symptoms was reported as adverse events of hypoglycemia. CTCAE version 4.03 was used to grade the severity of TEAEs. Grade 1 referred to mild AEs; Grade 2 referred to moderate AEs; Grade 3 referred to severe AEs; Grade 4 referred to AEs with life-threatening consequences, and urgent intervention was needed to manage them; Grade 5 referred to death related to AE.|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
2611969|NCT02038764|Primary|Number of Participants With All-Causality Treatment-Emergent Hypoglycemic Adverse Events|Number of participants with all-causality treatment-emergent hypoglycemic adverse events was reported. Any blood glucose values less than(<)55 mg/dL with or without symptoms was reported as adverse events of hypoglycemia.|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
2611970|NCT02038764|Primary|Number of Participants With All-Causality TEAEs Listed by Common Terminology Criteria for Adverse Events (CTCAE) Grade|TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug. CTCAE version 4.03 was used to grade the severity of TEAEs. Grade 1 referred to mild AEs; Grade 2 referred to moderate AEs; Grade 3 referred to severe AEs; Grade 4 referred to AEs with life-threatening consequences, and urgent intervention was needed to manage them; Grade 5 referred to death related to AE.|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
2611971|NCT02038764|Primary|Number of Participants With Treatment-Related TEAEs|Number of participants with treatment-related TEAEs were reported. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug.|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
2611972|NCT02038764|Primary|Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs)|Number of participants with all-causality treatment emergent adverse events were reported. An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug. TEAEs included both serious and non-serious AE|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
2611973|NCT02038764|Primary|Number of Participants With Dose Limiting or Intolerable Treatment Related Adverse Events (AEs)|Number of participants with dose limiting or intolerable treatment related adverse events (AEs) was reported. An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.|Day 1 through Day 127|All participants who received at least 1 dose of study medication.|||participants|||Number
2611974|NCT02038647|Other Pre-specified|Health Related Quality of Life (HRQOL )||Baseline up to Cycle 11, data cut-off: 03 January 2016 (approximately 9.8 months)|This is an exploratory endpoint.||||||
2611975|NCT02038647|Other Pre-specified|Biomarker Correlative Studies Including Circulating Tumor Cells and Circulating DNA Assessments||Day 1 cycle 1 in a 28-day cycle|This is an exploratory endpoint.||||||
2611976|NCT02038647|Secondary|Observed Plasma Concentration for Paclitaxel||Day 1 pre-dose and 1, 2-4, 3-6, 10-11 hours post-dose; Day 8, 2 hours post-dose; Day 15, 6-9 hours post-dose|Due to change in planned analysis, data was only collected and summarized for alisertib not for paclitaxel.||||||
2611977|NCT02038647|Secondary|Observed Plasma Concentration for Alisertib||Day 1 pre-dose and 1, 2-4, 3-6, 10-11 hours post-dose; Day 8, 2 hours post-dose; Day 15, 6-9 hours (hrs) post-dose|Safety population was defined as all participants who received at least 1 dose of any study drug. Number analyzed is the number of participants with evaluable data at the given time-point.|||nM||Standard Deviation|Mean
2611978|NCT02038647|Secondary|Time to Symptom Progression|Time to coughing/dyspnea/pain progression was defined as time from the date of randomization to date of first detection of progression. Coughing progression was defined as increase from baseline ≥10 in QLQ-LC13 cough scale/item score. Dyspnea progression was defined as increase from baseline ≥10 in QLQ-C30 dyspnea scale/item score. Pain progression was defined as increase from baseline ≥10 in QLQ-C30 pain scale score. EORTC QLQ-C30 is 30-item questionnaire with 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (fatigue, nausea, vomiting and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The QLQ-LC13 is 13-item scale for assessing treatment-specific symptoms in lung cancer. Total Score= 0-100 scale; for 5 functional scales and global quality-of-life scale, higher score=better level of functioning. For symptoms scale, higher score=higher level of symptoms.|Baseline up to Cycle 11, data cut-off: 03 January 2016 (approximately 9.8 months)|The ITT population was defined as all participants who were randomized to study treatment. Participant without coughing/dyspnea/pain progression were censored at their last assessment.|||months||95% Confidence Interval|Median
2612550|NCT02032420|Post-Hoc|Inability to Complete Assigned Task at All in Three Attempts|Some participants found the task too difficult to complete.|Immediately after training||||participants|||Number
2611979|NCT02038647|Secondary|Time to Symptom Relief|Time to symptom (coughing/dyspnea/pain) relief was defined as the time from the date of randomization to the date of first detection of coughing/dyspnea/pain relief, respectively.|Baseline up to Cycle 11, data cut-off: 03 January 2016 (approximately 9.8 months)|The ITT population was defined as all participants who were randomized to study treatment. Participants without coughing/dyspnea/pain relief were censored at their last assessment.|||months||95% Confidence Interval|Median
2611980|NCT02038647|Secondary|Percentage of Participants Experiencing Symptom Relief|Percentage of participants experiencing symptom relief, including coughing relief, dyspnea relief, and pain relief. Coughing relief is defined as a decrease from baseline ≥ 10 in QLQ-LC13 cough scale/item score. Dyspnea relief is defined as a decrease from baseline ≥ 10 in QLQ-C30 dyspnea scale/item score. Pain relief is defined as a decrease from baseline ≥ 10 in QLQ-C30 pain scale score. EORTC QLQ-C30 is 30-item questionnaire with 5 functional scales, 1 global health status scale, 3 symptom scales, 6 single items. Total Score=0-100 scale; for 5 functional scales and global quality-of-life scale, a higher score=a better level of functioning. For symptoms scale, higher score= higher level of symptoms. EORTC QLQ-LC13 is considered as standard instrument to assess the QL of lung cancer participants. Total Score=0-100. Higher score=increase in level of symptomatology.|Baseline up to Cycle 11, data cut-off: 03 January 2016 (approximately 9.8 months)|The ITT population was defined as all participants who were randomized to study treatment. Participants without coughing/dyspnea/pain relief were censored at their last assessment.|||percentage of participants||95% Confidence Interval|Number
2611981|NCT02038647|Secondary|Change From Baseline in Symptom (QLQ-LC13 Cough Scale, QLQ-C30 Dyspnea Scale, QLQ-C30 Pain Scale) Score at Cycle 5|European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 is 30-item questionnaire with 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (fatigue, nausea, vomiting and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions use 7-point scale (1=very poor - 7=Excellent). Total Score=0-100 scale; for 5 functional scales and global quality-of-life scale, a higher score=a better level of functioning. For symptoms scale, higher score= higher level of symptoms. EORTC QLQ-LC13 is considered as standard instrument to assess the quality of life (QL) of lung cancer participants. Total Score=0-100. Higher score=increase in level of symptomatology. The change between (QLQ-LC13 Cough Scale, QLQ-C30 Dyspnea Scale, QLQ-C30 Pain Scale) score collected at Cycle 5 relative to baseline.|Baseline up to Cycle 5 (approximately 4.6 months)|The ITT population was defined as all participants who were randomized to study treatment. Here number of participants analyzed are participants evaluated in this outcome measure at the specific timepoint.|||score on a scale||Standard Error|Least Squares Mean
2611982|NCT02038647|Secondary|Duration of Response (DOR)|DOR was defined as the time from the date of first documentation of a PR or better to the date of first documentation of PD for responders. PR was defined as ≥ 30% decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|From first documented response until disease progression until data cut-off 03 January 2016 (approximately 9.8 months)|The ITT population was defined as all participants who were randomized to study treatment. Responders were evaluated for this outcome measure. Responders without documentation of PD were censored at their date of last response assessment that was SD or better.|||days||95% Confidence Interval|Median
2611983|NCT02038647|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of participants who achieved CR, PR, or SD (when SD was a minimum of 8 weeks in duration). Duration of SD was defined as the time from the date of randomization to the date of first documentation of disease progression for participants who achieved SD as their best overall response. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as ≥ 30% decrease in sum of LD of target lesions in reference to Baseline sum LD. PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline until disease progression, death or EOT up to data cut-off: 03 January 2016 (approximately 9.8 months)|The ITT population was defined as all participants who were randomized to study treatment.|||percentage of participants||95% Confidence Interval|Number
2611984|NCT02038647|Secondary|Complete Response Rate (CRR)|CRR is defined as the percentage of participants who achieved CR as best response and based on Investigator's assessment according to RECIST v 1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.|Baseline until disease progression, death or EOT up to data cut-off: 03 January 2016 (approximately 9.8 months)|The ITT population was defined as all participants who were randomized to study treatment.|||percentage of participants||95% Confidence Interval|Number
2611985|NCT02038647|Secondary|Overall Response Rate (ORR)|ORR is defined as the percentage of participants who achieved CR or partial response (PR) as best response based on Investigator's assessment according to RECIST v 1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as ≥ 30% decrease in sum of LD of target lesions in reference to Baseline sum LD.|Baseline until disease progression, death or EOT up to data cut-off: 03 January 2016 (approximately 9.8 months)|The ITT population was defined as all participants who were randomized to study treatment.|||percentage of participants||95% Confidence Interval|Number
2611986|NCT02038647|Secondary|Overall Survival (OS)|OS was defined as the time in days from the date of randomization to the date of death due to any cause.|Contact every 2 months after EOT/disease progression until the sooner of death, study closure, or 14 months after the last participant was randomized up to data cut-off: 3 January 2016 (approximately 22 months)|The ITT population was defined as all participants who were randomized to study treatment. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.|||days||95% Confidence Interval|Median
2611987|NCT02038647|Secondary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with treatment. An AE can be any unfavorable and unintended sign (eg, clinically significant abnormal laboratory finding), symptom, or disease temporally associated with use of drug, whether or not it is considered related to drug. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) is any experience that suggests significant hazard, contraindication, side effect or precaution that:results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is congenital anomaly/birth defect or is medically significant per National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.|From the first dose through 30 days after the last dose of study medication: data cut-off 03 January 2016 (Up to 10.8 months)|The safety population was defined as all participants who received at least 1 dose of any study drug.|||percentage of participants|||Number
2611988|NCT02038647|Primary|Progression-Free Survival (PFS) as Determined by Investigator, Analyzed Using FDA Guidelines|PFS is defined as time in days from start of study treatment to first documentation of objective tumor progression based on Investigator's assessment or up to death due to any cause, whichever occurs first based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. Progressive disease (PD) was defined as ≥20% increase in sum longest diameter (LD) in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Every cycle for first 6 months and then every 2 months until disease progression or death or up to data cut-off: 03 January 2016 (approximately 22 months)|The intent-to-treat (ITT) population was defined as all participants who were randomized to study treatment. For participants who have not progressed and is last known to be alive, PFS was censored at the last response assessment that is stable disease (SD) or better as determined by Investigator, and analyzed using FDA Guidelines.|||days||95% Confidence Interval|Median
2611989|NCT02038569|Secondary|"Subjects With Controlled Disease According to the Patient's Global Assessment of Disease Severity on the Body at End of Treatment"|"Subjects with Controlled disease (i.e., Clear or Almost clear for subjects with at least Moderate disease at baseline, Clear for subjects with Mild disease at baseline) according to the patient's global assessment of disease severity on the body at end of treatment, defined as the last value recorded up to and including Week 8."|End of treatment|Full analysis set|||Participants|||Count of Participants
2611990|NCT02038569|Secondary|Percentage Change in PASI From Baseline to End of Treatment|Percentage change in Psoriasis area and severity index (PASI) score from baseline to end of treatment, defined as the last value recorded up to and including Week 8. Psoriasis area and severity index (PASI) assesses extent and severity of clinical signs of psoriasis vulgaris. Body surface is divided in 4 ares: head (incl. neck), arms (incl. hands), trunk (incl. flexures) and legs (incl. buttocks and feet). Each area is scored from 0-6 for extent of psoriasis and from 0-4 for redness, thickness, and scaliness, and an area PASI score is calculated. The total PASI score is calculated from each area's score. The PASI score ranges from 0 (clear skin) to 72 (maximum disease), a PASI score higher than 10 generally corresponds to moderate-to-severe disease.|From baseline to end of treatment|Full analysis set|||Percentage change in PASI score||Standard Deviation|Mean
2611991|NCT02038569|Secondary|"Subjects With Controlled Disease According to the Investigator's Global Assessment of Disease Severity on the Body at End of Treatment"|"Subjects with Controlled disease (i.e., Clear or Almost clear for subjects with at least Moderate disease at baseline, Clear for subjects with Mild disease at baseline) according to the investigator's global assessment of disease severity on the body at end of treatment, defined as the last value recorded up to and including Week 8."|End of treatment|Full analysis set|||Participants|||Count of Participants
2611992|NCT02038569|Secondary|Pharmacokinetic Evaluation T(½)|T(½) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects and betamethasone 17-propionate was only detected in 12 samples from 5 subjects, therefore it was not possible to calculate T(½) for betamethasone dipropionate or betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.|Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP|PK evaluation was performed in 32 subjects. Analysis set not defined in clinical trial protocol.|||h|||Number
2611993|NCT02038569|Secondary|Pharmacokinetic Evaluation T(Max)|T(max) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects and betamethasone 17-propionate was only detected in 12 samples from 5 subjects. Therefore it was not possible to calculate T(max) for betamethasone dipropionate and betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.|Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP|PK evaluation was performed in 32 subjects. Analysis set not defined in clinical trial protocol.|||h|||Number
2611994|NCT02038569|Secondary|Pharmacokinetic Evaluation C(Max)|C(max) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects and betamethasone 17-propionate was only detected in 12 samples from 5 subjects, therefore pharmacokinetic profiles could not be calculated. Presented C(max) values for betamethasone dipropionate and betamethasone 17-propionate are the the single highest concentrations measured in any sample at any time. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.|Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP|PK evaluation was performed in 32 subjects. Analysis set not defined in clinical trial protocol.|||pg/mL|||Number
2612551|NCT02032420|Secondary|Performer Fatigue|Self-reported trainee fatigue on a numerical rating scale (1= least fatigued; 10=most fatigued); lower scores indicate less fatigue|During task||||units on a scale||Inter-Quartile Range|Median
2611995|NCT02038569|Secondary|Pharmacokinetic Evaluation AUC(0-infinity)|"AUC(0-infinity) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects, and no subjects had enough positive samples to allow calculation AUC(0-infinity) for betamethasone dipropionate. Betamethasone 17-propionate was only detected in 12 samples from 5 subjects, and only 2 subjects had enough positive samples to calculate AUC(0-infinity). The mean value of AUC(0-infinity) for these 2 subjects is presented for betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.~The terms AUC(0-infinity) and AUC(all) are interchangeable, AUC(0-infinity) was used in the protocol whereas AUC(all) was used in the report. AUC(0-infinity) has been used here to be consistent with the protocol."|Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP|PK evaluation was performed in 32 subjects. Analysis set not defined in clinical trial protocol.|||pg*h/mL||Standard Deviation|Mean
2611996|NCT02038569|Secondary|Pharmacokinetic Evaluation AUC(0-t)|AUC(0-t) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects, and no subjects had enough positive samples to allow calculation AUC(0-t) for betamethasone dipropionate. Betamethasone 17-propionate was only detected in 12 samples from 5 subjects, and only 2 subjects had enough positive samples to calculate AUC(0-t). The mean value of AUC(0-t) for these 2 subjects is presented for betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.|Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP|PK evaluation was performed in 32 subjects. Analysis set not defined in clinical trial protocol.|||pg*h/mL||Standard Deviation|Mean
2611997|NCT02038569|Secondary|Change in Serum Alkaline Phosphatase From Baseline to Week 8|Change in serum alkaline phosphatase from baseline to Week 8|From baseline to Week 8|Safety analysis set|||mmol/L||Standard Deviation|Mean
2611998|NCT02038569|Secondary|Change in Serum Alkaline Phosphatase From Baseline to Week 4|Change in serum alkaline phosphatase from baseline to Week 4|From baseline to Week 4|Safety analysis set|||mmol/L||Standard Deviation|Mean
2611999|NCT02038569|Secondary|Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8|Change in urinary calcium:creatinine ratio from baseline to Week 8|From baseline to Week 8|Safety analysis set|||mmol/g||Standard Deviation|Mean
2612000|NCT02038569|Secondary|Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4|Change in urinary calcium:creatinine ratio from baseline to Week 4|From baseline to Week 4|Safety analysis set|||mmol/g||Standard Deviation|Mean
2612001|NCT02038569|Secondary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 8|Number of subjects with serum cortisol concentration of ≤18 mcg/dl at both 30 and 60 minutes after ACTH-challenge at Week 8|30 and 60 minutes after ACTH-challenge at Week 8|Per protocol analysis set|||Participants|||Count of Participants
2612002|NCT02038569|Secondary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 4|Number of subjects with serum cortisol concentration of ≤18 mcg/dl at both 30 and 60 minutes after ACTH-challenge at Week 4|30 and 60 minutes after ACTH-challenge at Week 4|Per protocol analysis set|||Participants|||Count of Participants
2612003|NCT02038569|Secondary|Adverse Events (AEs)|Number of Adverse Events (AEs)|8 weeks|Safety analysis set|||Adverse Events|||Number
2612004|NCT02038569|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment|Change in 24-hour urinary calcium excretion from baseline to end of treatment, defined as the last value recorded after baseline up to and including Week 8.|From baseline to end of treatment|Safety analysis set|||mmol/24hr||Standard Deviation|Mean
2612005|NCT02038569|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8|Change in 24-hour urinary calcium excretion from baseline to Week 8|From baseline to Week 8|Safety analysis set|||mmol/24hr||Standard Deviation|Mean
2612006|NCT02038569|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4|Change in 24-hour urinary calcium excretion from baseline to Week 4|From baseline to Week 4|Safety analysis set|||mmol/24hr||Standard Deviation|Mean
2612007|NCT02038569|Primary|Change in Albumin-corrected Serum Calcium From Baseline to End of Treatment|Change in albumin-corrected serum calcium from baseline to end of treatment, defined as the last value recorded after baseline up to and including Week 8.|From baseline to end of treatment|Safety analysis set.|||mmol/L||Standard Deviation|Mean
2612008|NCT02038569|Primary|Change in Albumin-corrected Serum Calcium From Baseline to Week 8|Change in albumin-corrected serum calcium from baseline to Week 8|From baseline to Week 8|Safety analysis set.|||mmol/L||Standard Deviation|Mean
2612009|NCT02038569|Primary|Change in Albumin-corrected Serum Calcium From Baseline to Week 4|Change in albumin-corrected serum calcium from baseline to Week 4|From baseline to Week 4|Safety analysis set.|||mmol/L||Standard Deviation|Mean
2612010|NCT02038569|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8|Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 8|30 minutes after ACTH-challenge at Week 8|Per protocol analysis set|||Participants|||Count of Participants
2612011|NCT02038569|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4|Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4|30 minutes after ACTH-challenge at Week 4|Per protocol analysis set|||Participants|||Count of Participants
2612012|NCT02038569|Primary|Adverse Drug Reactions (ADRs)|Number of Adverse Drug Reactions (ADRs)|8 weeks|Safety analysis set|||Number of adverse drug reactions|||Number
2612013|NCT02038543|Secondary|Mean Percent Conversion of Hydroxyproline (Hyp) to Urinary Glycolate (UGIc)|The overall contribution of Hyp catabolism to urinary oxalate (UOx) and glycolate (UGlc) excretion is determined by the excess mole percent enrichment of urine with 13C2-oxalate and glycolate corrected for the fraction of labelled [15N,13C5]-Hyp that is circulating in the plasma.|Participants will be followed for the duration of the study infusion and observations, an average of 24 hours|2 subjects from the PH Type Non 1,2,3 withdrew from the study. Subjects with PH Type Non 1,2,3 were not included in the analysis as only 1 subject completed the study.|||percent converted||Standard Error|Mean
2612014|NCT02038543|Primary|Mean Percent Conversion of Hydroxyproline (Hyp) to Urinary Oxalate (UOx)|The overall contribution of hydroxyproline catabolism to urinary oxalate (UOx) and glycolate (UGlc) excretion is determined by the excess mole percent enrichment of urine with 13C2-oxalate and glycolate corrected for the fraction of labelled [15N,13C5]-Hyp that is circulating in the plasma.|Participants will be followed for the duration of study infusion and observation, an average of 24 hours.|2 subjects from the PH Type Non 1,2,3 withdrew from the study. Subjects with PH Type Non 1,2,3 were not included in the analysis as only 1 subject completed the study.|||percent converted||Standard Error|Mean
2612015|NCT02038179|Primary|Change in Serum Levels of High Sensitivity C-reactive Protein|Serum level of high sensitivity C-reactive protein will be reported as a change during treatment phase (allopurinol 300 mg/day PO or placebo). Change in serum level of C-reactive protein is calculated by comparing serum values at the end of each treatment phase to pre-treatment levels.|4 weeks (pre-treatment vs. post-treatment serum levels)|Data reported is imputed for missing.|||mg/L||Standard Error|Mean
2612016|NCT02038179|Primary|Change in Flow-mediated Arterial Vasodilation|Compare endothelial function as indexed by flow-mediated arterial vasodilation (FMD) within each phase of treatment (allopurinol 300 mg/day PO or placebo). Percent (%) change in FMD is calculated by comparing FMD (%) at the end of each treatment phase to pre-treatment values.|4 weeks (pre-treatment vs. post-treatment FMD Values (%))|Missing data was handled with a multiple imputation approach|||percent change||Standard Error|Mean
2612017|NCT02038179|Primary|Change in Systolic Blood Pressure (SBP)|Compare systolic blood pressure (SBP) captured by wearing a 24 hour ambulatory blood pressure monitor during each phase of treatment (allopurinol 300 mg/day PO or placebo). Change in systolic blood pressure is calculated by comparing SBP at the end of each treatment phase to pre-treatment values.|4 weeks (pre-treatment vs. post-treatment SBP)|Missing data was handled with a multiple imputations approach|||mm Hg||Standard Error|Mean
2612018|NCT02038075|Other Pre-specified|Post Treatment Health Interview (PTHI)|Frequency, intensity, and location of each patient's accessing of medical services will be assessed via medical record review.|24 months|||||||
2612019|NCT02038075|Other Pre-specified|Suicide Cognitions Scale (SCS)|The SCS-R is an 18-item self-report measure that measures two aspects of suicide-specific hopelessness: 1) unlovability (which measures more trait-like aspects of hopelessness), and 2) unbearability (which measures more state-like aspects of hopelessness).|24 months|||||||
2612020|NCT02038075|Other Pre-specified|Interpersonal Needs Questionnaire (INQ)|The INQ is a 10-item self-report questionnaire that measures current beliefs about the extent to which the respondent feels connected to others (i.e., thwarted belongingness), and the extent to which he or she feels like a burden on the people in their lives (i.e., perceived burdensomeness).|24 months|||||||
2612021|NCT02038075|Other Pre-specified|Suicide Intent Scale|The SIS is a 15-item, interviewer-administered assessment of the intensity of an individual's intent to die at the time of a suicide attempt. It assesses verbal and nonverbal indicators of suicidal attempt including objective circumstances surrounding the attempt, and the attempters' perceptions of the attempt.|24 months|||||||
2612022|NCT02038075|Other Pre-specified|Structured Clinical Interview for DSM-IV, Axis I and II (SCID)|The SCID (patient version with psychotic screen) is a diagnostic instrument based on DSM-IV diagnostic criteria for Axis I disorders.|Intake|||||||
2612023|NCT02038075|Secondary|Beck Anxiety Inventory|The BAI is a 21-item scale that measures the severity of anxiety in adults and adolescents.|24 months|||||||
2612024|NCT02038075|Secondary|Beck Hopelessness Scale (BHS)|The BHS consists of 20 true-false statements designed to assess the extent of positive and negative beliefs about the future.|24 months|||||||
2612025|NCT02038075|Secondary|Beck Depression Inventory, Second Edition (BDI-II)|The BDI-II is a 21-item self-report instrument developed to measure severity of depression in adults and adolescents. Each of the items consists of four statements reflecting increasing levels of severity for a particular symptom of depression.|24 months|||||||
2612026|NCT02038075|Secondary|Scale for Suicide Ideation (SSI)|The SSI is a 21-item, interviewer-administered scale used to evaluate the current intensity of the patient's specific attitudes, behaviors, and plans to commit suicide. The SSI has moderately high internal consistency and good concurrent and discriminant validity for psychiatric outpatients. Inter-rater reliability has been found to be higher than .98, with good evidence of predictive validity.|24 months|||||||
2612027|NCT02038075|Primary|Estimated Percentage of Participants Making Suicide Attempt During 24-month Follow-up|The SASII is a clinician-administered interview designed to assess the factors involved in nonfatal suicide attempts and intentional self-injury. The SASII assesses variables related to method, reliability, lethality, impulsivity, likelihood of rescue, suicidal intent, consequences, and habitual self-injury. Interrater reliabilities for each item range from .87-.98, with the correlation for rater classification of behavior (i.e., suicide attempt or non-suicidal self-injury) being .92. The SASII demonstrates very high agreement in identifying and classifying suicide-related events when compared to clinician therapy notes, patient diary cards, and medical records (for events requiring medical attention).|24 months|intent to treat|||estimated percentage w/ suicide attempt|||Number
2612028|NCT02038049|Secondary|Number of Participants With On-Treatment Adverse Events, Serious Adverse Event, and Death|Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that VAY736 is safe for the treatment of patients with relapsing-remitting multiple sclerosis through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive statistics performed.|From first dosing (single administration, Day 1) up to End of Study Visit (EOS) depending on B cell recovery (ranging from week 48 to 216)|The Safety Set, which consisted of all patients who received at least one dose of study drug during the treatment period, was considered|||Participants|||Count of Participants
2612064|NCT02037984|Primary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:1x:2x vs. Prevnar 13®|The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.|Month 7 (1 month PD3)|Randomized and treated infants with results available for the outcome measure and no protocol violations are included.|||µg/mL||95% Confidence Interval|Geometric Mean
2612029|NCT02038049|Secondary|Proportion of Relapse-free Patients Over the 16 Weeks of the Treatment Period.|A relapse is defined as the appearance of a new neurological abnormality, or worsening of previously stable, or improving pre-existing neurological abnormality, separated by at least 30 days from the onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5 C) or infection. A relapse was considered confirmed when confirmed by an Extended disability status scale (EDSS)-certified physician who was not involved in the treatment of the patient, was blinded to treatment allocation, and had no access to patient medical records. It was recommended that this occurs within 5 days of the onset of symptoms. A relapse was confirmed when it was accompanied by an increase of at least half a point (0.5) on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Only descriptive statistics performed.|Week 0 (Day 1), Week 4, Week 8, Week 12, Week 16|Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered|||Participants|||Count of Participants
2612030|NCT02038049|Secondary|Number of Subjects Without Any New MRI Disease Activity at Weeks 4, 8, 12 and 16.|Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess patients without any new MRI disease activity (no new Gd-enhancing lesions nor new or enlarging T2 lesions). Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.|Week 4, Week 8, Week 12, Week 16|Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered|||Participants|||Number
2612031|NCT02038049|Secondary|T2 Burden of Disease (Total Volume of T2-weighted Lesions) at Weeks 4, 8, 12 and 16.|Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess T2 burden of disease. Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.|Week 4, Week 8, Week 12, Week 16|Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered|||mm3 of T2-weighted lesions|||Number
2612032|NCT02038049|Secondary|Number of New or Enlarging T2-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16|Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess T2 hyperintense lesions (new or enlarging T2-weighted lesions). Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.|Week 4, Week 8, Week 12, Week 16|Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered|||Lesions|||Number
2612033|NCT02038049|Secondary|Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16|Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess all new T1-weighted Gadolinium (Gd) enhancing lesions. Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.|Week 4, Week 8, Week 12, Week 16|Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered|||Lesions|||Number
2612034|NCT02038049|Secondary|Number of All T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 4, 8, 12 and 16|Magnetic resonance imaging (MRI) scanning of the brain was performed at screening/baseline, week 4, week 8, week 12 and week 16 to assess all T1-weighted Gadolinium (Gd) enhancing lesions. Each MRI scan was reviewed by a local neuro-radiologist. Only descriptive statistics performed.|Week 4, Week 8, Week 12, Week 16|Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered|||Lesions|||Number
2612035|NCT02038049|Primary|Number of New T1-weighted Gadolinium (Gd)-Enhancing Lesions at Weeks 8, 12 and 16|The effect of VAY736, compared to placebo on the cumulative number of new gadolinium [Gd]-enhancing lesions on T1-weighted brain MRI scans in relapsing-remitting multiple sclerosis (RRMS) patient population at weeks 8, 12 and 16. Only descriptive statistics performed.|Week 8, Week 12, Week 16|Pharmacodynamic (PD) analysis set, which consisted of all patients who received at least one dose of study drug during the treatment and one evaluable PD assessment, was considered|||Lesions|||Number
2612036|NCT02038023|Secondary|Safety as Measured by Number of Adverse Events|To evaluate the safety of IV low molecular weight iron dextran in pregnant women. Also to asses maternal and fetal outcomes-preterm delivery, low-birth weight deliveries, ER visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post partum transfusions, maternal hemoglobin at post-partum visit after IV iron supplementation groups. A questionaire with a list of symptoms to include nausea, dizziness, hypotension, edema, headache, abdominal pain, chest pain, cough, itching, fever, back pain, muscle cramps and rash are asked immediately after administration and phone calls at 24, 48 hours and 7 days.|4 weeks after infusion and 4 weeks post-partum||||minor adverse events|||Number
2612037|NCT02038023|Secondary|Percent Transferrin Saturation||4 weeks post infusion or post-partum|Of the 73 who received the infusion, 5 were lost to followup and 8 did not return for 4-week posttreatment bloodwork. Pretreatment (initial) and 4-week posttreatment laboratory studies are available for 60|||percent saturation (Fe/TIBC)||Standard Deviation|Mean
2612038|NCT02038023|Secondary|Serum Ferritin||4 weeks post infusion or post-partum|Of the 73 who received the infusion, 5 were lost to followup and 8 did not return for 4-week posttreatment bloodwork. Pretreatment (initial) and 4-week posttreatment laboratory studies are available for 60|||ng/mL||Standard Deviation|Mean
2612039|NCT02038023|Primary|Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD).||4 weeks after infusion or post-partum|Of the 73 who received the infusion, 5 were lost to followup and 8 did not return for 4-week posttreatment bloodwork. Pretreatment (initial) and 4-week posttreatment laboratory studies are available for 60|||Participants|||Count of Participants
2612134|NCT02037165|Secondary|"Electronic Visual Analogue Scale (VAS) (100mm VAS Post Laser Pain Scales) - Measured in the UVB-irradiated Skin Type"|"Electronic Visual Analogue Scale (100mm VAS Post Laser Pain scales) - measured in the UVB-irradiated skin type, where 0mm = 'no pain' and 100mm = 'severe pain'."|up to 24 hours(h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])|PDS|||units on a scale||Standard Deviation|Mean
2612040|NCT02038010|Post-Hoc|Toxicity of the Combination of BYL719 and T-DM1 Treatment by Cohort|"Toxicity profile of BYL719 in combination with T-DM1 will be assessed using National Cancer Institute's Common Toxicity Criteria for Adverse Events version 4.0 (CTCAEv4.0). Toxicity is defined as an AE that is determined to be at least possibly related to at least one of the study drugs: BYL719 and T-DM1.~In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|From the time of treatment initiation thoughout treatment until 30 days post last dose. Range of cycles completed =1 to 19 where 1 cycle =21 days|Any patient that received a dose of study drug was evaluable for this outcome measure|||participants|||Number
2612041|NCT02038010|Other Pre-specified|Best Response of BYL719 Administered in Combination With T-DM1 by Cohort|"Best Response (BR) of patients treated with BYL719 and T-DM1 combination treatment is assessed every 9 weeks with physical exam and imaging and defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). BR is based on evaluation of target and non-target lesions. Clinical lesions will only be considered measurable when they are superficial. Patients that completed at least 3 cycles of treatment and had imaging at 1st response time point were considered evaluable for this objective.~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): >=30% decrease in the sum of the longest diameter (LD) of target lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions"|From the start of treatment and every 3 cycles during treatment where 1 cycle =21 days, median number of cycles is 11 and range of cycles is 3-19.||||participants|||Number
2612042|NCT02038010|Other Pre-specified|Clinical Benefit Rate (CBR) of BYL719 Administered in Combination With T-DM1 by Cohort|Clinical Benefit Rate (CBR) patients treated BYL719 and T-DM1 combination treatment is defined as the number of patients with Complete Response + Partial Response + Stable Disease for over 6 months documented as their best response, assessed every 3 cycles (every 9 weeks) with physical exam and imaging (CT chest/abdomen/pelvis and bone scan, or PET/CT) and defined by RECIST guidelines. Patients that completed at least 3 cycles of treatment and had imaging at 1st response time point were considered evaluable for this objective.|From the start of treatment and every 3 cycles (1 cycle =21 days) while on treatment where the median number of cycles is 11 and range is 3-19 cycles.||||participants|||Number
2612043|NCT02038010|Other Pre-specified|Number of Patients With Changes in PIK3CA Gene, PTEN Expression and Akt/mTOR Downstream Markers|Patients tumor tissue collected during biopsy will be evaluated by immunohitochemistry (IHC) and Next Generation Sequencing (NGS) to see if the study drugs are efficacious on patients who have this alteration.|Baseline|The sample size was so small for each cohort and due to the exploratory nature of outcome measure, there wouldn't any merit to separating out dose cohorts. Mutations were collected for patients combined, reported on and correlated with response descriptively. No data was collected/no analysis was completed on each dose cohort separately.|||Participants|||Count of Participants
2612044|NCT02038010|Secondary|Objective Response Rate (ORR) of BYL719 Administered in Combination With T-DM1 by Cohort|"ORR for patients treated with BYL719 in combination with T-DM1 assessed every 3 cycles (every 9 weeks) with imaging and Best Response defined by RECIST v1.1. ORR is defined as number of patients with Complete Response (CR)+Partial Response (PR) documented as their Best Response (confirmed 4 weeks later). Response is based on evaluation of target and non-target lesions. Clinical lesions will only be considered measurable when they are superficial. Patients that completed at least 3 cycles of treatment and had imaging at 1st response time point were considered evaluable for this objective.~Target Lesions:~CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD.~For Non-Target Lesions:~CR: Disappearance of all non-target lesions and normalization of tumor marker level Non-complete Response (Non-CR): Persistence of one or more non-target lesion(s)"|From the start of treatment and every 3 cycles during treatment where 1 cycle =21 days, median number of cycles is 11 and range of cycles is 3-19.||||participants|||Number
2612045|NCT02038010|Secondary|Progression-Free Survival (PFS) of BYL719 Administered in Combination With T-DM1 for All Patients Treated on Study.|Progression-Free Survival (PFS) for patients treated with BYL719 and T-DM1 in combination is measured for all patients from the time of treatment initiation until the first documentation of progressive disease or death from any cause. It will be assessed every 3 months up to 1 year after discontinuation of the study drugs. Patients that completed at least 3 cycles of treatment and had imaging at 1st response time point were considered evaluable for this objective.|From the start of treatment and every 3 months up to 1 year after discontinuation of treatment. 1 Cycle = 21 days. Median number of cycles is 11 and range is 3-19 cycles.|The sample size was so small for each cohort that it was decided that there wouldn't any merit to separating out the dose cohorts and Kaplan Meier curves were completed on all patients combined and patients with or without prior T-DM1 treatment. No data was collected and no analysis was completed on each dose cohort separately.|||Months||95% Confidence Interval|Median
2612046|NCT02038010|Secondary|Pharmacokinetics (PK) of BYL719 Administered in Combination With T-DM1.|To assess the pharmacokinetics (PK)of BYL719, blood will be drawn from patients on Day 1, 8, and 15 of Cycles 1, 2 and 3 where 1 Cycle = 21 days. After that blood will be drawn once every 3 cycles. PK parameters of BYL719 including peak and trough concentrations as an estimate of the steady-state concentration, elimination clearance, interindividual variability of the elimination clearance, and the effect of PK parameters with prolonged administration of BYL719 will be obtained. Steady state concentration will be analyzed to see if there is any relationship with efficacy or toxicity.|Day 1, 8, and 15 of Cycles 1, 2, and 3, then every 3 Cycles (1 Cycle =21 days) while on treatment where the median number of cycles is 11 and range is 3-19 cycles.|No data from the blood draws was collected or analyzed for this objective.||||||
2612065|NCT02037984|Primary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:1x vs. Prevnar 13®|The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.|Month 7 (1 month PD3)|Randomized and treated infants with results available for the outcome measure and no protocol violations are included.|||µg/mL||95% Confidence Interval|Geometric Mean
2612047|NCT02038010|Primary|Maximum Tolerated Dose (MTD) of BYL719 in Combination With T-DM1.|"Safety of BYL719 in combination with T-DM1 will be assessed during the first 21 days (1 cycle=21 days) which will assist in providing the MTD. Adverse Events including dose limiting toxicities (DLT), changes in physical findings, or clinical laboratory results as well as cardiac toxicity (changes in cardiac function, which will be measured by use of echocardiogram or MUGA scan) will be evaluated.~For each dose level, 3 patients will be treated. If none (0 of 3) show a DLT, dose will be escalated for the next cohort of patients.~If 2 or 3 have a DLT, then the previous dose will be considered the MTD. If 2 or 3 in cohort 1 (starting dose) experience a DLT, then the dose in -1 cohort will be used.~If 1 of 3 patients has a DLT, then an additional 3 patients will be added to that dose level.~If 1 of 6 has a DLT, then the dose will be escalated. If 2 of 6 have a DLT, then this dose will be considered the MTD. If 3 or more of 6 have a DLT, then the previous dose will be the MTD."|The 1st 21 days (Cycle 1) of treatment|5 patients enrolled into Cohort 1 were assess for DLTs, one patient in Cohort 1 was determined not to be evaluable after review; the patient only received one dose of treatment total. Only the first 3 patients in Cohort -1 were assessed for DLTs due to 3+3 design in assessing for DLTs and determining the MTD.|||mg per day|||Number
2612048|NCT02038010|Primary|Dose Limiting Toxicity (DLT) of Dose-escalating BYL719 in Combination With T-DM1|"DLTs of BYL719 in combination with T-DM1 will be assessed using National Cancer Institute's Common Toxicity Criteria for adverse events version 4.0 (except for hyperglycemia). A DLT is described any grade 3 or higher, clinically significant toxicity (excluding alopecia) experienced during the first 21 days following first dose of BYL719 that is determined to be at least possibly related to study medication. Lower grades may also be considered DLTs if they lead to a dose interruption of more than 7 consecutive days of BYL719. In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|The 1st 21 days (Cycle 1) of treatment|5 patients enrolled into Cohort 1 were assess for DLTs, one patient in Cohort 1 was determined not to be evaluable after review; the patient only received one dose of treatment total. Only the first 3 patients in Cohort -1 were assessed for DLTs due to 3+3 design.|||Participants|||Count of Participants
2612049|NCT02037984|Primary|Estimated Fold-Rise Per-Unit Change on Serotype-specific Antibody Concentrations Following an Increase in Aluminum Phosphate Adjuvant (APA) Concentration 1 Month Postdose 3 (PD3) in Infants|A mulitvariate regression model was used to evaluate the impact of increasing APA concentration on the natural logarithm of serotype-specific antibody concentrations 1 month PD3. Data points show the mean estimated fold-rise-per-unit change in antibody concentration following an increase in APA. For each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) serotypes, values >1.0 show an increase in antibody concentration whereas values <1.0 show a decrease in antibody concentration.|Month 7 (1 month PD3)|All randomized and treated infants with results available for the outcome measure and no protocol violations in the V114 arms are included.|||Estimated Fold-rise per-unit Change||95% Confidence Interval|Mean
2612050|NCT02037984|Secondary|Percentage of Participants With ≥4-fold-rise From Baseline in Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults|The percentage of participants with ≥4-fold-rise from baseline in each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month after a single vaccination with V114 were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay.|Month 2 (1 month after a single vaccination)|Randomized and treated adults with results available for the outcome measure and no protocol violations are included.|||Percentage of Participants||95% Confidence Interval|Number
2612051|NCT02037984|Secondary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month After Vaccination in Adults|The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month after a single vaccination with V114 were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.|Month 2 (1 month after a single vaccination)|Randomized and treated adults with results available for the outcome measure and no protocol violations are included.|||µg/mL||95% Confidence Interval|Geometric Mean
2612052|NCT02037984|Secondary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 4 (PD4) in Infants|The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD4 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay.|One month following the 4th vaccination (approximately 13 to 16 months of age)|Randomized and treated infants with results available for the outcome measure and no protocol violations are included.|||µg/mL||95% Confidence Interval|Geometric Mean
2612053|NCT02037984|Secondary|Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:2x vs Prenar 13®|The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.|One month following the 4th vaccination (approximately 13 to 16 months of age).|Randomized and treated infants with results available for the outcome measure and no protocol violations are included.|||Percentage of Participants|||Number
2612054|NCT02037984|Secondary|Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 0.5x:0.5x:2x vs Prenar 13®|The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.|One month following the 4th vaccination (approximately 13 to 16 months of age).|Randomized and treated infants with results available for the outcome measure and no protocol violations are included.|||Percentage of Participants|||Number
2612083|NCT02037776|Secondary|Change From Baseline in Global Overall Symptom (GOS)|The GOS scale are calculated by a total score of a 7-point Likert scale ranging from 1 = no problem to 7 = a very severe problem over 8 questions. The point scores of GOS are calculated from changes from baseline at final evaluation.|Baseline and Week 8||||units on a scale||Standard Deviation|Mean
2612055|NCT02037984|Secondary|Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:2x:2x vs Prenar 13®|The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.|One month following the 4th vaccination (approximately 13 to 16 months of age).|Randomized and treated infants with results available for the outcome measure and no protocol violations are included.|||Percentage of Participants|||Number
2612056|NCT02037984|Secondary|Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 2x:1x:2x vs Prenar 13®|The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.|One month following the 4th vaccination (approximately 13 to 16 months of age).|Randomized and treated infants with results available for the outcome measure and no protocol violations are included.|||Percentage of Participants|||Number
2612057|NCT02037984|Secondary|Percentage of Infant Participants Achieving the Pneumococcal Immunoglobulin G (IgG) Serotype-specific Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 4 (PD4): V114 1x:1x:1x vs Prenar 13®|The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation.|One month following the 4th vaccination (approximately 13 to 16 months of age).|Randomized and treated infants with results available for the outcome measure and no protocol violations are included.|||Percentage of Participants|||Number
2612058|NCT02037984|Secondary|Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 1x Aluminum Phosphate Adjuvant (APA)|The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation with 1x APA and varying pneumococcal polysaccharide.|Month 7 (1 month PD3)|Randomized and treated infants with results available for the outcome measure and no protocol violations are included.|||Percentage of Participants||95% Confidence Interval|Number
2612059|NCT02037984|Secondary|Percentage of Infant Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 μg/mL at 1 Month Postdose 3 (PD3): V114 Formulations With 2x Aluminum Phosphate Adjuvant (APA)|The percentage of infant participants with antibody responses meeting the World Health Organization (WHO)-accepted threshold value of ≥0.35 μg/mL was determined for each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) pneumococcal serotype. Antibody levels were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay for each V114 formulation with 2x APA and varying pneumococcal polysaccharide.|Month 7 (1 month PD3)|Randomized and treated infants with results available for the outcome measure and no protocol violations are included.|||Percentage of Participants||95% Confidence Interval|Number
2612060|NCT02037984|Primary|Estimated Fold-Rise Per-Unit Change in Serotype-specific Antibody Concentrations Following an Increase in Polysaccharide Concentrations in Infants at 1 Month Postdose 3 (PD3)|A mulitvariate regression model was used to evaluate the impact of increasing polysaccharide concentration from 1x to 2x on the natural logarithm of serotype-specific antibody concentrations 1 month PD3. Data points show the mean estimated fold-rise-per-unit change in antibody concentration following an increase from 1x to 2x in polysaccharide concentration. For each Prevnar 13®-type (PT) or non-Prevnar 13®-type (non-PT) serotypes, values >1.0 show an increase in antibody concentration whereas values <1.0 show a decrease in antibody concentration.|Month 7 (1 month PD3)|All randomized and treated infants with results available for the outcome measure and no protocol violations in the V114 arms are included. Results are pooled across arms to determine the impact of increased polysaccharide concentration on antibody concentrations across V114 formulations.|||Estimated Fold-rise per-unit Change||95% Confidence Interval|Mean
2612061|NCT02037984|Primary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 1x:1x:2x vs. Prevnar 13®|The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.|Month 7 (1 month PD3)|Randomized and treated infants with results available for the outcome measure and no protocol violations are included.|||µg/mL||95% Confidence Interval|Geometric Mean
2612062|NCT02037984|Primary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 0.5x:0.5x:2x vs. Prevnar 13®|The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.|Month 7 (1 month PD3)|Randomized and treated infants with results available for the outcome measure and no protocol violations are included.|||µg/mL||95% Confidence Interval|Geometric Mean
2612063|NCT02037984|Primary|Geometric Mean Concentration (GMC) of Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibodies at 1 Month Postdose 3 (PD3) in Infants: V114 2x:2x:2x vs. Prevnar 13®|The IgG antibody GMCs of each Prevnar 13®-type (PT) or non-Prevnar 13® type (non-PT) serotype at 1 month PD3 following V114 or Prevnar 13® treatment were determined with the pneumococcal electrochemiluminescence (Pn ECL) assay. Data reflect the GMC of each serotype.|Month 7 (1 month PD3)|Randomized and treated infants with results available for the outcome measure and no protocol violations are included.|||µg/mL||95% Confidence Interval|Geometric Mean
2615131|NCT02004366|Secondary|Hyperglycemia|Subjects with BG > 300 mg/dl|Inpatient (average 5 days) and outpatient up to 12 weeks||||Participants|||Count of Participants
2612066|NCT02037984|Primary|Percentage of Infant Participants Discontinuing From Study Treatment Due to an Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. For infants, AEs were monitored for up to 14 days following each vaccination.|Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age)|Infant participants who received V114 are included.|||Percentage of Participants|||Number
2612067|NCT02037984|Primary|Percentage of Infant Participants Experiencing ≥1 Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. For infants, AEs were monitored for up to 14 days following each vaccination.|Up to 14 days after the 4th vaccination (approximately 12.5 to 15.5 months of age)|Infant participants who received V114 are included.|||Percentage of Participants|||Number
2612068|NCT02037984|Primary|Percentage of Adult Participants Discontinuing From Study Treatment Due to an Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 days|Adult participants who received V114 are included.|||Percentage of Participants|||Number
2612069|NCT02037984|Primary|Percentage of Adult Participants Experiencing ≥1 Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 days|Adult participants who received V114 are included.|||Percentage of Participants|||Number
2612070|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 72 Hours Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 72 hour post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
2612071|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 60 Hours Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 60 hour post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
2612072|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 48 Hours Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 48 hour post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
2612073|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 36 Hours Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 36 hour post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
2612074|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 24 Hours Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 24 hour post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
2612075|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 12 Hours Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 12 hour post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
2612076|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 6 Hours Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 6 hour post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
2612077|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 3 Hour Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 3 hour post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
2612078|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 30 Min Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 30 min post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
2612079|NCT02037893|Secondary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)15 Min Post First Dose|"The relative change from baseline in pain intensity as measured by changes in FLACC scores or FPS-R scores between baseline and 15 and 30 minutes, and 3, 6, 12, 24, 36, 48, 60, and 72 hours after first dose.~The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Change from Baseline to 15 min post first dose|The intent-to-treat (ITT) population included all subjects who were randomized to receive treatment and had at least one postscreening efficacy assessment at the timepoint of interest.|||units on a scale||Standard Error|Mean
2612080|NCT02037893|Primary|Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)|"The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain.~The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain."|Baseline and 1 hour after a single dose|Intent-to-Treat population|||units on a scale||Standard Deviation|Mean
2612081|NCT02037776|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HAD)|"The HAD is a 14-item scale with 2 subscales of depression (Question 1, 3, 5, 7, 9, 11, and 13) and anxiety (Question 2, 4, 6, 8, 10, 12, and 14). Each item on the questionnaire is scored from 0 to 3 (ranging from 0 to 21, lower value represents a better outcome).~The point scores of HAD are calculated from changes from baseline in overall (sum of scores for depression and anxiety, i.e., total point score ranging from 0 to 42, lower value represents a better outcome), depression, and anxiety at final evaluation."|Baseline and week 8||||score||Standard Deviation|Mean
2612082|NCT02037776|Secondary|Change From Baseline in Short-form Health Survey-8 (SF-8)|"The SF-8 scores comprised of Physical component summary (PCS) scores (ranging between 5.32-70.69, higher value represents a better outcome) and Mental component summary (MCS) scores (ranging between 10.11-74.51, higher value represents a better outcome), and a total scores of PCS and MCS using a formula specified in SF-8 Scoring Algorithm.~The point scores of SF-8 are calculated from changes from baseline in PCS and MCS at final evaluation."|Baseline and week 8||||units on a scale||Standard Deviation|Mean
2612084|NCT02037776|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM)|"PAGI-SYM questionnaire is composed of the following 6 categories that consisted of Questions 1 to 20 (each question composed of 6 subscales, i.e., point scores from 0 to 5, lower value represents a better outcome). Subscale scores are calculated by averaging across items in each category. A total score (lower value represents a better outcome, ranging from 0 to 5) is calculated as the mean of the subscale scores.~Heartburn/Regurgitation, Nausea/Vomiting, Postprandial Fullness/Early satiety, Bloating, Upper Abdominal Pain, and Lower Abdominal Pain~The point scores of PAGI-SYM are calculated from changes from baseline in total score and each category score at final evaluation."|Baseline and Week 8||||units on a scale||Standard Deviation|Mean
2612085|NCT02037776|Secondary|Change From Baseline in Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (GERD) (Modified FSSG)|"The modified FSSG questionnaire is composed of 7 questions regarding GERD symptoms (Questions 1-7, scored from 0 to 4) ranging between 0-28, lower value represents a better outcome, and 7 questions regarding dyspeptic symptoms (Questions 8-14, each question scored from 0 to 4) ranging between 0-28, lower value represents a better outcome, and a total scores, ranging from 0 to 56, lower value represents a better outcome of the all questions (Questions 1-14). Each question was assigned a score based on the frequency of symptoms.~The point scores of modified FSSG are calculated from changes from baseline in each score for all symptoms (sum of point scores from Questions 1-14), GERD symptoms, and dyspeptic symptoms at final evaluation."|Baseline and Week 8||||units on a scale||Standard Deviation|Mean
2612086|NCT02037776|Primary|Patient's Evaluation of Symptomatic Improvement by Overall Treatment Efficacy (OTE)|"Patient's Evaluation of Symptomatic Improvement by OTE is classified into the following 7 categories:~Significantly improved~Improved~Slightly improved~No change~Slightly worse~Worse~Much worse~The numbers of patients at the final evaluation (i.e, the latest evaluable time point of the all patients including discontinued patients) are shown by category."|8 weeks||||Participants|||Count of Participants
2612087|NCT02037607|Primary|Number of Participants With Post-operative Ultrasound Without Evidence of Thromboembolism|The number of participants with post-operative ultrasound without evidence of thromboembolism|within 72 hours after surgery||||Participants|||Count of Participants
2612088|NCT02037568|Secondary|Caregiver Reaction Assessment|"The Caregiver Reaction Assessment (CRA) is a measure of caregiver burden. This instrument contains 24 items reflecting the total caregiver situation in the past month. The scale includes 5 subscales. The scores of each scale are summed to compute a total score. Minimum score (best value)=5. Maximum score (worst value)=25. Higher values reflect the experience of a higher burden."|Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant|Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3).|||units on a scale||95% Confidence Interval|Least Squares Mean
2612089|NCT02037568|Secondary|Change in Caregiver Telomerase Activity Over Time|Telomerase activity will be assessed as a measure of the ability to reverse cellular aging processes. Because telomerase activity were not normally distributed, the data were log transformed.|Baseline (prior to transplant), 3 months and 6 months after transplant|Caregiver Control group missing responses (n = 8). Caregiver Intervention group: missing responses (n = 2).|||log (enzyme unit)||95% Confidence Interval|Least Squares Mean
2612090|NCT02037568|Secondary|Change in Caregiver Telomere Length Over Time|Telomere length was assessed as a measure of cellular aging in blood samples from participants. Because telomere length were not normally distributed, the data were log transformed.|Baseline (prior to transplant), 3 months and 6 months after transplant|Caregiver Control group missing responses (n = 8). Caregiver Intervention group: missing responses (n = 2).|||log (T/S ratio)||95% Confidence Interval|Least Squares Mean
2612091|NCT02037568|Secondary|Change in Adrenal Activity Over Time|Cortisol measured in hair will be used as a retrospective measure of activation of the hypothalamic pituitary adrenal axis. Because hair cortisol were not normally distributed, the data were log transformed.|Baseline (prior to transplant), 3 months (caregiver only), and 6 months after transplant.|Caregiver Control group missing responses (n = 8). Caregiver Intervention group: missing responses (n = 2).|||log (pg/mg)||95% Confidence Interval|Least Squares Mean
2612092|NCT02037568|Secondary|Spielberger State-Trait Anxiety Inventory|"The Spielberger State and Trait Anxiety Inventory (STAI) is a validated self-reporting instrument used to assess anxiety in adults. The inventory consists of state anxiety, which evaluates how the subject feels currently (transient anxiety). The scale consists of 20 questions, and a higher score indicates greater anxiety. Total score ranges from 20 (no anxiety) to 80 (maximum anxiety)."|Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant|Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3).|||units on a scale||95% Confidence Interval|Least Squares Mean
2612093|NCT02037568|Secondary|Center for Epidemiological Studies Depression Scale|"Center for Epidemiological Studies Depression Scale (CESD) is a self-report 20-item scale designed to measure current depressive symptoms. Total score range from 0-60, with a score at or above 16 reflecting significant depressive symptomatology."|Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant|Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3).|||units on a scale||95% Confidence Interval|Least Squares Mean
2612094|NCT02037568|Secondary|Perceived Stress Scale|"The Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. The total score range is 0-56. A higher score indicates greater stress."|Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant|Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3).|||units on a scale||95% Confidence Interval|Least Squares Mean
2612095|NCT02037568|Primary|Caregiver Distress - Principal Component Analysis|Caregiver Distress is a composite score is created from a principal component analysis (PCA). This PCA extracted the first principal component from summary variables of Center for Epidemiological Studies Depression Scale, Spielberger State and Trait Anxiety Inventory, and Perceived Stress Scale. The composite distress score has a mean of 0.0 and SD of 1.0, scale ranges from -2.06 - 3.73. Higher score indicates greater distress.|Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant|Caregiver Control group missing responses (n = 7). Caregiver Intervention group: missing responses (n = 3).|||units on a scale||95% Confidence Interval|Least Squares Mean
2612096|NCT02037568|Primary|Functional Assessment of Cancer Treatment - Blood/Marrow Transplant|"Functional Assessment of Cancer Treatment - Blood/Marrow Transplant (FACT-BMT) is used to assess the life quality of patients. The scale includes 5 subscales. The scores of each scale are summed to compute a total score. The scale range is 0-148. Higher score indicates better life quality."|Baseline (prior to transplant), 6 weeks, 3 months and 6 months after transplant|Patient Control group missing responses (n = 14). Caregiver Intervention group: missing responses (n = 6).|||units on a scale||95% Confidence Interval|Least Squares Mean
2612097|NCT02037555|Primary|Percentage of Subjects With Any Component of a Major Morbidity Composite|"Major morbidity composite defined as a composite of any one or more of the following:~Postoperative mortality (deaths occurring within 30 days of the operation or occurring during the primary hospitalization).~Stroke (clinical diagnosis of focal or global neurological deficit of abrupt onset caused by disturbance in cerebral blood supply).~Acute kidney injury (increase of serum creatinine levels to >2.0 mg/dL and twice the baseline level or a new requirement for dialysis postoperatively).~Surgical reexploration (return to operating room because of bleeding, tamponade, graft occlusion or other cardiac reason).~Arterial or venous thromboembolic event (perioperative myocardial or mesenteric infarction, peripheral thromboembolism, acute coronary graft thrombosis, intracardiac thrombosis, deep vein thrombosis, pulmonary embolism).~Prolonged mechanical ventilation (>24 hours).~Infection (deep sternal-wound infection and/or bloodstream infections)."|Up to Day 30 +/- 4 days|All subjects Treated and Operated On Excluding 4 Subjects with Non-verifiable Data|||Participants|||Count of Participants
2612098|NCT02037477|Secondary|Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with markedly abnormal laboratory values for Chemistry, Hematology and Urinalysis during the study is reported.|At Screening, baseline (Day -3), administration period (Day 1, Day 8), and post-test (Day 28)|Safety analysis set - All participants who received at least 1 dose of study drug.|||participants|||Number
2612099|NCT02037477|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (at Rest) Findings||At Screening, baseline (Day -3), administration period (Day 8), and post-test (Day 28)|Safety analysis set - All participants who received at least 1 dose of study drug.|||participants|||Number
2612100|NCT02037477|Secondary|Number of Participants With Abnormal Changes From Baseline in Vital Signs|Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).|At screening, baseline (Day -3, Day -2, Day -1), administration period (Days 1, Day 2, Day 7, Day 8), and post-test (Day 28)|Safety analysis set - All participants who received at least 1 dose of study drug.|||participants|||Number
2612101|NCT02037477|Secondary|Frequency of Adverse Events|The frequency of adverse events by type, seriousness, time to onset. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.|31 days|Safety analysis set - All participants who received at least 1 dose of study drug.|||participants|||Number
2612102|NCT02037477|Primary|Intragastric pH Time Course Over 24 Hours|Intragastric pH was measured continuously for 24 hours (hr) by pH monitor. pH holding time ratio (HTR) is the percentage of time a pH is maintained at a particular level. For example, pH 4 HTR is the percentage of time the pH = 4.|At baseline (Day -2 to Day -1), administration period (Days 1 to Day 2 and Days 7 to Day 8)|Pharmacodynamic (PD) Analysis Set - Participants receiving study medication who completed protocol procedures without serious violation of the protocol were eligible for PD analysis. All 10 subjects from Cohort 1 were included. Three subjects in Cohort 2 were excluded from the PD analysis set, which therefore consisted of 7 subjects.|||percentage of time||Standard Deviation|Mean
2612103|NCT02037438|Secondary|Change in CGCAHPS Health Information Technology Measure #3 After 12 Months|"Helpfulness of Provider's Website in Giving Patient Information About Patient's Care and Tests (Effectiveness of technology as measured by the Health Information Technology item set of the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey [CGCAHPS]). This included composite measures of helpfulness of provider's website in giving information about care and tests. The ratings for the following four questions were averaged for each participant: In the last 12 months, how often was it easy to find these lab or other test results on the website? In the last 12 months, how often were these lab or other test results put on the website as soon as you needed them? In the last 12 months, how often were these lab or other test results presented in a way that was easy to understand? In the last 12 months, how often were the visit notes easy to understand? The responses and point values were: never (1), sometimes (2), usually (3), and always (4)."|12 months|Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 268 CONV and 270 PCCM participant data were acceptable for statistical analysis for this outcome measure.|||units on a scale||Standard Deviation|Mean
2612104|NCT02037438|Secondary|Change in CGCAHPS Health Information Technology Measure #1 After 12 Months|"Helpfulness of Provider's Use of Computers During a Visit (Effectiveness of technology as measured by the Health Information Technology item set of the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey [CGCAHPS]). This included composite measures of helpfulness of provider's use of computers during a visit. The ratings for the following two questions were averaged for each participant: During your visits in the last 12 months, was this provider's use of a computer or handheld device helpful to you? The point values for the responses were: yes, definitely (1), yes, somewhat (2), and no (3). During your visits in the last 12 months, did this provider's use of a computer or handheld device make it harder or easier for you to talk with him or her? The point values for the responses were: easier (1), not harder or easier (2), harder (3)."|12 months|Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 423 CONV and 426 PCCM participant data were acceptable for statistical analysis for this outcome measure.|||units on a scale||Standard Deviation|Mean
2612117|NCT02037425|Secondary|Migraine Disability Assessment Scale (MIDAS)|"Comparison between Group A, B, and C for MIDAS total scores (effect migraine headaches have on subjects daily function) measured at baseline and weeks 12, 24, and 36.~Total score of disability ranges:~0 to 5, MIDAS Grade I, Little or no disability~6 to 10, MIDAS Grade II, Mild disability~11 to 20, MIDAS Grade III, Moderate disability~21+, MIDAS Grade IV, Severe disability Score ranges from 0-450. No subscales are present."|Baseline, Week 12, Week 24, and Week 36 Post Randomization||||units on a scale||Standard Deviation|Mean
2615132|NCT02004366|Secondary|Hypoglycemia <70 mg/dl|Subjects with Hypoglycemia <70 mg/dl|Inpatient (average 5 days) and outpatient up to 12 weeks||||Participants|||Count of Participants
2612105|NCT02037438|Secondary|Change in CGCAHPS Provider Communication After 12 Months|"Communication of provider as measured by the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CGCAHPS). This comprised How Well Providers (or Doctors) Communicate with Patients The ratings for the following four questions were averaged for each participant: In the last 12 months, how often did this provider explain things in a way that was easy to understand? In the last 12 months, how often did this provider listen carefully to you? In the last 12 months, how often did this provider show respect for what you had to say? In the last 12 months, how often did this provider spend enough time with you? The responses and point values were: never (1), sometimes (2), usually (3), and always (4)."|12 months|Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 530 CONV and 525 PCCM participant data were acceptable for statistical analysis for this outcome measure.|||units on a scale||Standard Deviation|Mean
2612106|NCT02037438|Primary|Change in SF-36 Version 2 Health Survey Vitality Score After 12 Months|"The vitality scale score of the Short Form-36 (SF-36) Version 2 Health Survey was compared at the end-of study (12 months) and was derived from the following four questions: How much of the time during the past 4 weeks… Did you feel full of life? Did you have a lot of energy? Did you feel worn out? Did you feel tired? The possible responses and point values were: all of the time (1), most of the time (2), some of the time (3), a little of the time (4), and none of the time (5). The scale is transformed to a 0-100 scale, with the lower the score indicating more disability."|12 months|Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 540 CONV and 539 PCCM participant data were acceptable for statistical analysis for this outcome measure.|||units on a scale||Standard Deviation|Mean
2612107|NCT02037438|Primary|Change in CGCAHPS Global Rating After 12 Months|"Global rating of the provider from the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey (CGCAHPS) compared between the two arms at end of study (12 months). The global rating instructions specify: Using any number from 0 to 10, where 0 is the worst provider possible, and 10 is the best provider possible, what number would you use to rate this provider?"|12 months|Although 1135 participants (574 CONV, 561 PCCM) completed at least one of the primary outcome measures, 546 CONV and 535 PCCM participant data were acceptable for statistical analysis for this outcome measure.|||units on a scale||Standard Deviation|Mean
2612108|NCT02037425|Other Pre-specified|Neuronal Regrowth|Compare neuronal regrowth in the skin biopsies with duration of benefit of onabotulinumtoxinA in Groups A, B, C from baseline to 12 weeks post randomization. Neuronal regrowth change was scored on a 0-3 point scale with 0 being no change from baseline in regrowth and 3 being significant change from baseline.|Baseline & Week 12 Post Randomization|Only a subset of subjects (n = 14) completed this endpoint for the trial based on the protocol design.|||units on a scale||Standard Deviation|Mean
2612109|NCT02037425|Secondary|Duration of onabotulinumtoxinA Over 3 Injection Cycles|Compare duration of benefit of onabotulinumtoxinA response through 3 injection cycles as measured by headache days per week (including the last 4 weeks of every injection cycle). A percent of responders was calculated using a 30% reduction of the number of headache days compared to average number of headache per week during baseline.|Weeks 9, 10, 11, 12, 21, 22, 23, 24, 33, 34, 35, 36 Post Randomization||||percentage of responders|||Number
2612110|NCT02037425|Secondary|Consistency of Response to onbotulinumtoxinA Over Three Injection Cycles|Compare the consistency of duration of onabotulinumtoxinA response by the group assignment at 12 weeks to assessments at 24, and 36 weeks evaluations as measured by the number of responders. A responder is defined as a 30% reduction from baseline in the number of headache days.|Weeks 12, 24, and 36 Post Randomization||||participants|||Number
2612111|NCT02037425|Secondary|Acute Medication Usage|Comparison of acute medication usage between Groups A, B, and C during baseline, Treatment Period 1, 2, and 3.|From day 1 (first day of baseline) to day 281 (84th day of injection cycle 3) plus or minus 12 days||||number of medications used||Standard Deviation|Mean
2612112|NCT02037425|Secondary|Sleep Quality Question|Comparison between Group A, B, and C for sleep quality scores measured at baseline and weeks 12, 24, and 36 post-randomization. A single sleep quality question was asked indicating quality of sleep over the past four weeks. The scale ranged from 1-5, with 1 being very poor quality and 5 being very good quality of sleep.|Baseline, Week 12, Week 24, and Week 36 Post Randomization||||units on a scale||Standard Deviation|Mean
2612113|NCT02037425|Secondary|State-Trait Anxiety Inventory (STAI)|Comparison between Group A, B, and C for STAI scores measured at baseline and weeks 12, 24, and 36. Scores range from 20-80, with 20 indicating lower levels of anxiety most generally, and 80 indicating higher levels of anxiety most generally.|Baseline, Week 12, Week 24, and Week 36 Post Randomization||||units on a scale||Standard Deviation|Mean
2612114|NCT02037425|Secondary|Beck Depression Inventory II (BDI-II)|Comparison between Group A, B, and C for BDI-II scores measured at baseline and weeks 12, 24, and 36. A total score of 0-10 = these ups and downs are considered normal, 11-16 = mild mood disturbance,17-20 = borderline clinical depression, 21-30 = moderate depression, 31-40 = severe depression, over 40 = extreme depression|Baseline, Week 12, Week 24, and Week 36 Post Randomization||||units on a scale||Standard Deviation|Mean
2612115|NCT02037425|Secondary|Physician Global Impression of Change (PGIC)|Comparison between Group A, B, and C for PGIC scores measured at weeks 12, 24, and 36. the PGIC scale scores range from 0-7 with 0 being Very Much Worse and 7 being Very Much Improved. A higher score indicates a greater impression of change.|Week 12, Week 24, and Week 36 Post Randomization||||units on a scale||Standard Deviation|Mean
2612116|NCT02037425|Secondary|Social Readjustment Rating Scale (SRRS)|Comparison between Group A, B, and C for SRRS scores (impact of common stressors) measured at baseline and weeks 12, 24, and 36. Scores can range from 0 to an undetermined amount, as subjects are allowed to rate unlisted events according to their own sense of stress. A total lower than 150 suggests a low level of stress and a low probability of developing a stress-related disorder. Scores greater than 150 suggest higher levels of stress and higher probabilities of developing stress-related disorders.|Baseline, Week 12, Week 24, and Week 36 Post Randomization||||units on a scale||Standard Deviation|Mean
2612118|NCT02037425|Secondary|Headache Days|Comparison of headache days per month over each injection cycle between Groups A, B, and C (Baseline (28 days), Treatment Period 1(84 days), Treatment Period 2(84 days), and Treatment Period 3(84 days). Subjects will remain in their assigned groups based on assessment at 12 weeks.|From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 days||||number of headache days||Standard Deviation|Mean
2612119|NCT02037425|Primary|Duration of onabotulinumtoxinA Over 3 Injection Cycles in Groups A, B, and C|Compare the duration of onabotulinumtoxinA response through the 3 injection cycles of the study for Groups A, B, and C as measured by headache days during each period (Baseline (28 days), Treatment Period 1(84 days), Treatment Period 2(84 days), and Treatment Period 3(84 days). Duration of response is defined as a 30% reduction in the number of headache days compared to baseline.|From day 29 (first day of injection cycle 1) to day 281 (84th day of injection cycle 3) plus or minus 12 days||||percentage of responders|||Number
2612120|NCT02037425|Primary|Subject Global Impression of Change|Changes in the Subject's Global Impression of Change (SGIC) measured at weeks 12, 24, and 36 for Groups A, B, and C. Subject global impression of change was measured on a 7 point scale with 0 being Very Much Worse and 7 Very Much Improved.|Weeks 12, 24, and 36 Post Randomization|Subjects included in this outcome measure analysis include those completing treatment period 1 injection cycle and returning at visit 3.|||units on a scale||Standard Deviation|Mean
2612121|NCT02037347|Secondary|Time-to-cessation of Epidermal Necrosis||The number of days between the start of palifermin administration and cessation of further epidermal necrosis up to 14 days||||days|||Number
2612122|NCT02037347|Secondary|Time-to-mucosal Re-epithelialization||The number of days between the start of palifermin administration and complete re-epithelialization of oral mucosa up to 14 days|Adverse event experienced by participant precluded measuring this outcome.||||||
2612123|NCT02037347|Primary|Time-to-cutaneous Re-epithelialization||The number of days between the start of palifermin administration and complete re-epithelialization of skin up to 14 days||||days|||Number
2612124|NCT02037230|Secondary|Time From Date of Registration to Date of Documented Disease Progression|Time from date of registration to date of documented disease progression summarized by Kaplan-Meier method. The time frame for data collection varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.|Up to 48 months following treatment||||months||90% Confidence Interval|Median
2612125|NCT02037230|Secondary|Overall Survival|Overall survival (OS) summarized by Kaplan-Meier curves and characterized by descriptive statistics such as median OS. The time frame for data collection for OS varied depending on the length of patient follow-up, which ranged from 1.8 months to 47.2 months. Patients who enrolled soon after the study opened may have been followed longer than patients who enrolled later, toward the end of the study.|Up to 48 months following treatment||||months||90% Confidence Interval|Median
2612126|NCT02037230|Secondary|Number of Patients With Phosphorylation Inhibition of Greater Than 0|During the first cycle of treatment, patients underwent 2 biopsies: 3 h after treatment with gemcitabine (but before MK- 1775), and 2 hours after MK-1775. WEE1 signaling was assessed using immunohistochemistry (IHC) to measure phosphorylation of various markers including Cdk1 (Y15). Inhibition was quantified as the within subject change in the above markers between the two biopsy timepoints. Descriptive statistics of inhibition across subjects (for each marker) were calculated and reported by dose level.|First cycle of treatment|20 participants were evaluable for this outcome measure. Two sequential skin punch biopsies were obtained from 20 of the 34 study participants.|||participants|||Number
2612127|NCT02037230|Primary|Maximum Tolerated Dose (MTD) of AZD1775 (MK-1775) When Used Concurrently With Gemcitabine and Radiation Therapy.|Probability of dose limiting toxicities was calculated for each dose (p[DLT/d]) using the Time to Event Continual Reassessment Method (TITE-CRM). The target DLT rate was 0.30. Dose level 1 (150 mg AZD1775) was determined to be the MTD and recommended phase 2 dose (RP2D).|The observation period for MTD is defined as the first 4 cycles of treatment (with a 3 week break between cycle 3 and cycle 4), for a total of 105 days in length.|All participants who received at least one dose of the study drug were evaluable for MTD.|||mg|||Number
2612128|NCT02037204|Other Pre-specified|Health Care Use and Costs|To assess the healthcare use and costs related to the procedure as well as the health-related work leave during the study period.|18 months|||||||
2612129|NCT02037204|Other Pre-specified|Structural Repair|To examine parameters of structural repair at one year after treatment using MRI and a second-look arthroscopy.|12 months|||||||
2612130|NCT02037204|Secondary|Clinical Improvement, Knee Injury and Osteoarthritis Outcome Score|Clinical improvement as measured by patient reported outcome scores. The questionnaire has been developed to evaluate the symptoms and limitations for patients with osteoarthritis. The outcome of the KOOS-scale varies from 0-100, where 0 indicates the greatest possible problems and is the worst outcome and 100 indicates no problems.|3 and 18 months|Differences in clinical outcome between baseline and 3 and 12 months after surgery were tested by a repeated measures analysis of variance (ANOVA).|||units on a scale||Standard Deviation|Mean
2612131|NCT02037204|Primary|Safety: Adverse Events|Adverse events rate|18 months|All patients were monitored for the duration of the studie for inflammation and signs of a foreign body response by an independent physician using standardized clinical measures, pain assessment by numeric rating scale for pain and blood analysis including serum C-reactive protein, erythrocyte sedimentation rate and leukocyte count.|||participants|||Number
2612132|NCT02037165|Secondary|Weighted Needle (Pain) Threshold (WNT) in the Secondary Flare Area of Capsaicin-irritated Skin|"Weighted needle (pain) threshold (WNT) in the secondary flare area of capsaicin-irritated skin. The weighted needle (pain) threshold (WNT) will be determined (with regard to investigation of mechanical hyperalgesia in the secondary hyperalgesia zone around the primary capsaicin application zone) by fixed weight steps - contact made by rounded needle tip to skin (ranging from 1 mN to 512 mN)."|up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])|PDS|||millinewton (mN)||Standard Deviation|Mean
2612133|NCT02037165|Secondary|"Electronic Visual Analogue Scale (100mm VAS Post Laser Pain Scales) - Measured in the Capsaicin-irritated Skin Type."|"Electronic Visual Analogue Scale (100mm VAS Post Laser Pain scales) - measured in the capsaicin-irritated skin type, where 0mm = 'no pain' and 100mm = 'severe pain'."|up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])|PDS|||units on a scale||Standard Deviation|Mean
2612135|NCT02037165|Secondary|"Single Central P2-component Amplitudes - Measured in Capsaicin-irritated Skin Type"|"Single central P2-component amplitudes - measured in capsaicin-irritated skin type."|up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])|PDS|||µv||Standard Deviation|Mean
2612140|NCT02037165|Primary|Overall Peak-to-Peak(PtP) N2/P2-component Amplitude of Laser (Somatosensory/Radiant Heat) Evoked Potentials (LEP) in Ultraviolet B (UVB) -Irradiated Skin|"Overall Peak-to-Peak (PtP) N2/P2-component amplitude of Laser (somatosensory/radiant heat) evoked potentials (LEP) in UVB-irradiated skin.~Treated set (TS)"|up to 24 hours (h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])|pharmacodynamic set(PDS): included all subjects from the TS who provided in any treatment period a baseline value and at least 1 PD profile post drug administration for the primary or secondary PD endpoint, which was considered evaluable, and without (important) protocol violation(s) with respect to the statistical evaluation of PD endpoints.|||Microvolts (µv)||Standard Deviation|Mean
2612141|NCT02037061|Secondary|Overall Pain Beyond Day of Discharge|Pain measured using the pain numeric rating scale from 0-10 (0=no pain, 10= worst pain imaginable)|6 weeks||||units on a scale||Standard Deviation|Mean
2612142|NCT02037061|Secondary|Need for Intervention for Postoperative Pain|Need for intervention through the use of trigger point injection, referral to pelvic floor physical therapy, or reoperation|6-weeks||||participants|||Number
2612143|NCT02037061|Primary|Postoperative Gluteal Pain|Pain measured using a pain numeric rating scale from 0 to 10 (0=no pain, 10= worst pain imaginable)|6-weeks||||units on a scale||Standard Deviation|Mean
2612144|NCT02036840|Primary|Number of Subjects With Antibiotic Related Adverse Event||24 hours||||participants|||Number
2612145|NCT02036775|Secondary|Plateau Time During Which Concentration of the Analyte in Plasma Exceeds 75% of Cmax ss|Plateau time during which concentration of the analyte in plasma exceeds 75% of Cmax ss (T(C>75% Cmax ss))|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set|||hours||Full Range|Median
2612146|NCT02036775|Secondary|Time Period When Concentration of the Analyte Exceeds Cav ss|Time period when the concentration of the analyte exceeds Cav ss (T (C>Cav ss))|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set|||hours||Full Range|Median
2612147|NCT02036775|Secondary|Peak-trough Swing|Peak-trough swing (PTS) calculated as ((Cmax,ss - Cmin,ss / Cav,ss)*100)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set|||percentage of ng/mL||Standard Deviation|Mean
2612148|NCT02036775|Secondary|Peak-trough Fluctuation Between Minimum and Maximum Concentration of the Analyte in Plasma|Peak-trough fluctuation between minimum and maximum concentration of the analyte in plasma (PTF)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set|||ng/mL||Standard Deviation|Mean
2612149|NCT02036775|Secondary|Time From Dosing to the Maximum Concentration of the Analyte in Plasma at Steady State|Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax ss). For Lasolvan 30mg and Lasolvan 60mg, tmax ss was determined as tmax ss 0-12 and tmax ss 12-24.|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set|||hours||Full Range|Median
2612150|NCT02036775|Secondary|Average Concentration of the Analyte in Plasma in the Time Interval of 0 to 24 h at Steady State|Average concentration of the analyte in plasma in the time interval of 0 to 24 h at steady state (Cav ss)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2612151|NCT02036775|Secondary|Steady State Concentration of the Analyte in Plasma at the End of Dosing Interval|Steady state concentration of the analyte in plasma at the end of dosing interval (Cmin ss)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2612152|NCT02036775|Secondary|Rate of Absorption at Steady State (Cmax ss/AUCss 0-24)|Metric which characterises the rate of absorption at steady state (Cmax ss/AUCss 0-24)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set|||1/h||Geometric Coefficient of Variation|Geometric Mean
2612153|NCT02036775|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State During 0-24 h, Adjusted to a Daily Dose of 60 mg|Area under the concentration-time curve of the analyte in plasma at steady state during 0-24 h, adjusted to a daily dose of 60 mg (AUCss 0-24 norm)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2612154|NCT02036775|Primary|Maximum Measured Concentration of the Analyte in Plasma at Steady State|Maximum measured concentration of the analyte in plasma at steady state (Cmax ss)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|PK-BA set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2612181|NCT02036515|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 52|The change from baseline is the Week 52 systolic blood pressure minus the Week 0 systolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one systolic blood pressure measurement (baseline or post-baseline).|||mmHg||Standard Error|Least Squares Mean
2612155|NCT02036775|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 24 h at Steady State|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h at steady state (AUCss 0-24)|Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg|Pharmacokinetic (PK) set relative bioavailability set (PK-BA set) which includes all subjects in the treated set who completed 3 periods and for whom the PK profiles in 3 periods could be adequately characterized in respect to at least 1 of the PK parameters of primary interest without important protocol violations relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2612156|NCT02036645|Secondary|Immunogenicity: Anti-drug Antibody Titer|Immunogenicity: Anti-drug antibody titer, subject counted if titer 50 or greater on any test, else 0 if all <50|4 months SAD (6 tests over 4 months; week 1, 2, 4, 8, 12, 16); 7 months MAD (7 monthly tests)|Safety Population|||Participants|||Number
2612157|NCT02036645|Secondary|Medi1814 Concentration in CSF Samples|Medi1814 concentration in CSF Samples; number of sampled subjects with a value above the lower limit of quantification|SAD Day 29; MAD Day 85|Pharmacokinetic population (subjects dosed with Medi1814)|||Participants|||Number
2612158|NCT02036645|Secondary|Biomarker: Total Amyloid-beta 1-42 in Plasma|Biomarker: Total Amyloid-beta 1-42 in plasma, mean percent change from baseline|Day 29 in SAD; Day 85 in MAD|Pharmacodynamic population (with non zero baseline values)|||% change||Standard Deviation|Mean
2612159|NCT02036645|Secondary|Biomarkers: Amyloid-beta in Cerebral Spinal Fluid (Two Amyloid Bets Peptides of 40 and 42 Amino Acids Were Assessed)|Biomarkers: Amyloid-beta in cerebral spinal fluid, mean percent change from baseline|Day 29 in SAD; Day 85 in MAD|Pharmacodynamic population (with non zero baseline values)|||% change||Standard Deviation|Mean
2612160|NCT02036645|Secondary|Mean Termination Half Life (t 1/2) of Medi1814|Mean termination half life (t 1/2) of Medi1814 during 28 day period after dose administration start (SAD Day 1 dose, MAD 3rd dose)|1 month|Pharmacokinetic population (subjects dosed with Medi1814)|||days||Standard Deviation|Mean
2612161|NCT02036645|Secondary|Maximum Plasma Concentration (Cmax) of Medi1814|Maximum plasma concentration (Cmax) of Medi1814 during 28 day period after dose administration start (prior to dosing, during infusion, 1, 2, 4, 8, 24, 48 hr, 7, 14,21, and 28 days)|1 month|Pharmacokinetic population (subjects dosed with Medi1814)|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2612162|NCT02036645|Secondary|Area Under the Concentration Time Curve (AUC) Time 0 to t (28 Days After 1st Dose SAD and MAD and After 3rd Dose in MAD, Day 57)|Area Under the Concentration time curve (AUC) time 0 to t; calculated from Just prior to dose administration start to 28th day after dose (pre infusion, during infusion, 1,2,4,8,24,48 hr 7, 14, 21, and 28 day)|1 month|Pharmacokinetic Population (subjects treated with Medi1814)|||ng x day/mL||Geometric Coefficient of Variation|Geometric Mean
2612163|NCT02036645|Primary|Tolerability as Measured by Participant Withdrawal for an Adverse Event|Tolerability measured by participant withdrawal for an adverse event from randomization through end of study|4 months SAD; 7 months MAD|Safety Population|||Participants|||Number
2612164|NCT02036580|Secondary|Immunogenecity|The incidence rate of positive serum antibodies to tralokinumab will be reported.|From baseline to Week 48|Safety population|||Patients|||Number
2612165|NCT02036580|Secondary|Serum Tralokinumab Concentration Data|Serum tralokinumab concentration data will be summarized by treatment group.|From baseline to Week 48 (Week 0 [post-dose, within +5 minutes after end of infusion], Week 4 [pre-dose], Week 12 [pre-dose]. Week 28, Week 40, Week 48)|PK population|||Microgram per milliliter||Standard Deviation|Mean
2612166|NCT02036580|Primary|Safety and Tolerability Primarily Assessed by the Number of Patients With Adverse Events|Adverse events and serious adverse events using the Safety Population. Other variables used for the safety assessments include electrocardiogram, vital signs, and routine laboratory assessments. These variables as well as their changes from baseline will be summarized descriptively.|From baseline to Week 48 (treatment-emergent only)|Safety population|||Patients|||Number
2612167|NCT02036541|Primary|Mean Change in IOP From Baseline|Mean change in IOP from baseline was calculated for subjects who completed the 12-month visit and the worst within-eye IOP was used for subjects who underwent a glaucoma-related secondary surgical intervention.|12 Months|All subjects who completed the 12-month visit or underwent a glaucoma-related secondary surgical procedure prior to the 12-month visit were evaluated in this analysis.|||mmHg||Standard Deviation|Mean
2612168|NCT02036541|Primary|Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications|Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications. Subjects who underwent a glaucoma-related secondary surgical intervention prior to the 12-month visit were considered failures in this analysis.|12 Months|All subjects who completed the 12-month visit or underwent a glaucoma-related secondary surgical procedure prior to the 12-month visit were evaluated in this analysis.|||Participants|||Count of Participants
2612169|NCT02036515|Secondary|Change From Baseline in EQ-5D-3L Score at Week 52|"The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 3-15 with 3 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions. EQ-5D-3L also includes an EQ VAS that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Decrease from baseline in EQ-5D-3L signifies improvement. Total index EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best). Data presented exclude data following the initiation of rescue therapy."|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one EQ-5D-3L measurement (baseline or post-baseline).|||Score on a scale||95% Confidence Interval|Least Squares Mean
2612182|NCT02036515|Secondary|Percentage of Participants With an A1C <7% (53 mmol/Mol) at Week 52|A1C is measured as percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).|||Percentage of participants|||Number
2612170|NCT02036515|Secondary|Change From Baseline in EQ-5D-3L Questionnaire Score at Week 26|"The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 3-15 with 3 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions. EQ-5D-3L also includes an EQ VAS that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Decrease from baseline in EQ-5D-3L signifies improvement. Total index EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best). Data presented exclude data following the initiation of rescue therapy."|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one EQ-5D-3L measurement (baseline or post-baseline).|||Score on a scale||95% Confidence Interval|Least Squares Mean
2612171|NCT02036515|Secondary|Baseline EQ-5D 3-level Version (EQ-5D-3L) Questionnaire Score|"The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 1-15 with 3 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions. EQ-5D-3L also includes an EQ visual analogue score (VAS) that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Total index EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best)."|Baseline|Analysis population included all randomized participants who took at least one dose of study medication and had a baseline EQ-5D-3L measurement.|||Score on a scale||Standard Deviation|Mean
2612172|NCT02036515|Secondary|Change From Baseline in HOMA-%β at Week 52|HOMA-%β is a well-accepted means of assessing fasting β-cell function, and is calculated using measured C-peptide and glucose levels and is measured as a percentage of a normal reference population. HOMA-%β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one HOMA-%β measurement (baseline or post-baseline).|||Percentage||95% Confidence Interval|Least Squares Mean
2612173|NCT02036515|Secondary|Change From Baseline in HOMA-%β at Week 26|HOMA-%β is a well-accepted means of assessing fasting β-cell function, and is calculated using measured C-peptide and glucose levels and is measured as a percentage of a normal reference population. HOMA-%β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one HOMA-%β measurement (baseline or post-baseline).|||Percentage||95% Confidence Interval|Least Squares Mean
2612174|NCT02036515|Secondary|Baseline Homeostasis Model Assessment of β-cell Function (HOMA-%β) Value|HOMA-%β is a well-accepted means of assessing fasting β-cell function, and is calculated using measured C-peptide and glucose levels and is measured as a percentage of a normal reference population. HOMA-%β = [20 x fasting insulin (μU/mL)] / [fasting plasma glucose (mmol/L) - 3.5]|Baseline|Analysis population included all randomized participants who took at least one dose of study medication and had HOMA-%β measurement at baseline.|||Percentage||Standard Deviation|Mean
2612175|NCT02036515|Secondary|Time to Initiation of Glycemic Rescue by Week 52|Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant). Data presented are the minimum and maximum times to the initiation of rescue therapy in days.|Up to week 52|Analysis population included all randomized participants who took at least one dose of trial treatment.|||Days|||Number
2612176|NCT02036515|Secondary|Time to Initiation of Glycemic Rescue by Week 26|Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant). Data presented are the minimum and maximum times to the initiation of rescue therapy in days. Below data include data from 1 participant in the Placebo arm who continued Phase A treatment for an additional 30 days.|Up to Week 26 (plus 30 days for 1 placebo participant)|Analysis population included all randomized participants who took at least one dose of trial treatment|||Days|||Number
2612177|NCT02036515|Secondary|Percentage of Participants Receiving Glycemic Rescue Medication by Week 52|Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant).|Week 52|Analysis population included all randomized participants who took at least one dose of trial treatment.|||Percentage of participants|||Number
2612178|NCT02036515|Secondary|Percentage of Participants Receiving Glycemic Rescue Medication by Week 26|Glycemic rescue medication was initiated for participants who met progressively more stringent glycemic rescue criteria. Rescue medication included glimepiride (or insulin glargine if glimepiride was not considered appropriate for the participant).|Week 26|Analysis population included all randomized participants who took at least one dose of trial treatment.|||Percentage of participants|||Number
2612179|NCT02036515|Secondary|Change From Baseline in Sitting Diastolic Blood Pressure at Week 52|The change from baseline is the Week 52 diastolic blood pressure minus the Week 0 diastolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one diastolic blood pressure measurement (baseline or post-baseline).|||mmHg||Standard Error|Least Squares Mean
2612180|NCT02036515|Secondary|Change From Baseline in Sitting Diastolic Blood Pressure at Week 26|The change from baseline is the Week 26 diastolic blood pressure minus the Week 0 diastolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one diastolic blood pressure measurement (baseline or post-baseline).|||mmHg||Standard Error|Least Squares Mean
2612183|NCT02036515|Secondary|Change From Baseline in Body Weight at Week 52|The change from baseline is the Week 52 body weight minus the Week 0 body weight. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one body weight measurement (baseline or post-baseline).|||kg||95% Confidence Interval|Least Squares Mean
2612184|NCT02036515|Secondary|Change From Baseline in FPG at Week 52|The change from baseline is the Week 52 FPG minus the Week 0 FPG. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one FPG measurement (baseline or post-baseline).|||mg/dL||95% Confidence Interval|Least Squares Mean
2612185|NCT02036515|Secondary|Change From Baseline in Hemoglobin A1C at Week 52|A1C is measured as percent. Thus this change from baseline reflects the Week 52 A1C percent minus the Week 0 A1C percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 52|Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).|||Percent||95% Confidence Interval|Least Squares Mean
2612186|NCT02036515|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 26|The change from baseline is the Week 26 systolic blood pressure minus the Week 0 systolic blood pressure. Sitting blood pressure was measured in triplicate. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one systolic blood pressure measurement (baseline or post-baseline).|||mmHg||Standard Error|Least Squares Mean
2612187|NCT02036515|Secondary|Percentage of Participants With an A1C <7% (53 mmol/Mol) at Week 26|A1C is measured as percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).|||Percentage of participants|||Number
2612188|NCT02036515|Secondary|Change From Baseline in Body Weight at Week 26|The change from baseline is the Week 26 body weight minus the Week 0 body weight. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one body weight measurement (baseline or post-baseline).|||kg||95% Confidence Interval|Least Squares Mean
2612189|NCT02036515|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26|The change from baseline is the Week 26 FPG minus the Week 0 FPG. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one FPG measurement (baseline or post-baseline).|||mg/dL||95% Confidence Interval|Least Squares Mean
2612190|NCT02036515|Primary|Percentage of Participants Discontinuing Study Treatment Due to an AE|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.|Up to Week 52|Analysis population consisted of all randomized participants who took at least one dose of study medication.|||Percentage of participants|||Number
2612191|NCT02036515|Primary|Percentage of Participants Experiencing An Adverse Event (AE)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.|Up to Week 54|Analysis population consisted of all randomized participants who took at least one dose of study medication.|||Percentage of participants|||Number
2612192|NCT02036515|Primary|Change From Baseline in Hemoglobin A1C at Week 26|A1C is measured as percent. Thus this change from baseline reflects the Week 26 A1C percent minus the Week 0 A1C percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population included all randomized participants who took at least one dose of study medication and had at least one A1C measurement (baseline or post-baseline).|||Percent||95% Confidence Interval|Least Squares Mean
2612193|NCT02036424|Primary|Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven|Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images. The image is presented in grid form which divides that retina into sections. The center most section (CST) is used for this outcome measurement.|baseline to month seven||||microns|Participants|Standard Deviation|Mean
2612194|NCT02036424|Primary|Mean Visual Acuity Change|Visual acuity was obtained using ETDRS method and the total number of letters correct using that method was used to calculate mean visual acuity change.|baseline to month 7||||ETDRS letters|Participants|Standard Deviation|Mean
2612195|NCT02036320|Primary|"Lens Does Not Exhibit Hula Hoop Effect"|"The number of subjects that did not exhibit a hula hoop effect as recorded by Eye Care Practitioner (ECP) judgment of acceptable physiology, in primary gaze, without a slit lamp."|15 mins post insertion|The analysis population consists of subjects that completed all study visits, without a major protocol deviation|||Subject|||Number
2612196|NCT02036320|Primary|Cosmetic Lens Fit Acceptance|The number of subject eyes that were classified as having acceptable cosmetic lens fit in primary gaze, without a slit lamp.|15 mins post insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||Eyes|Eyes||Number
2612197|NCT02036320|Primary|Mechanical Lens Fit Acceptance|The number of subject eyes that were classified as having acceptable mechanical lens fit, with a slit lamp.|15 mins post insertion|The analysis population consists of subjects that completed all study visits without a major protocol deviation.|||Eyes|Eyes||Number
2612198|NCT02036294|Secondary|Probability for Survival Without Death or a COPD- Related Acute Care Event at 6 Months Post Index-hospitalization, Estimated Using the Kaplan-Meier Method|Kaplan-Meier probability estimates that a participant would have their first event (death or COPD- related hospitalization or ED visit) sometime after 6 months from their index- hospitalization. The estimates are provided as the proportion of participants who do not have an event at 6 months post their index hospitalization.|Measured at 180 days post-discharge from index hospitalization|All participants whose medical records were available to confirm whether a hospitalization or ED visit is COPD-related|||Proportion of participants||95% Confidence Interval|Number
2612199|NCT02036294|Secondary|Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm|This outcome measures the mean change in patient participants' quality of life as measured by the Saint George's Respiratory Questionnaire (SGRQ) score over the 3 month study period within each study arm.The St. George Respiratory Questionnaire (SGRQ) is a widely used validated disease- specific instrument that measures health-related quality of life. The SGRQ measures, using patient self-report, disease impact on symptoms, patient activity, and daily life. The total score for SGRQ ranges from 0 to 100, with higher scores indicating more limitations. The change in a patient's quality of life was calculated as the difference in their total score at 3 months post index-hospitalization from baseline. A difference of 4 points in total score is considered a clinically meaningful difference.|Baseline to 3 months post index-hospitalization|Not all participants could be reached to complete the survey|||units on a scale||Standard Deviation|Mean
2612200|NCT02036294|Secondary|Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm|The primary outcome measure in this study is the mean number of COPD-related hospitalizations and ED visits per patient within each study arm. The number of hospital and ED visits per patient were counted at 3 months post 'index-hospitalization'. Index-hospitalization refers to the hospitalization in which the patient was enrolled into the study. A COPD- related hospitalization was defined as a hospitalization with discharge diagnosis of COPD exacerbation or Pneumonia; a hospitalization where the participant was admitted for congestive heart failure but received treatment for COPD exacerbation (nebulizer treatment plus steroids) ; or, admitted for symptoms pertaining to COPD and received steroids. A COPD- related ED visit was defined as a visit where the treating physician stated that the visit reason is COPD; or, where the participant was discharged on treatment with oral steroids or on treatment for pneumonia.|Measured at 3 months post 'index-hospitalization'|Data was analyzed for all participants unless: 1) participant died during the 3 months study period (we have to exclude deaths from this analysis because we cannot calculate a full count of hospital or ED visits during the 3 months period if the participant had died before the 3 months have elapsed ) ; 2) participant withdrew from the study.|||COPD-related visits per participant||Standard Deviation|Mean
2612201|NCT02036294|Secondary|Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm|The primary outcome measure in this study is the mean number of COPD-related hospitalizations and ED visits per patient within each study arm . The number of hospital and ED visits per patient were counted at 1 month post 'index-hospitalization'. Index-hospitalization refers to the hospitalization in which the patient was enrolled into the study. A COPD- related hospitalization was defined as a hospitalization with discharge diagnosis of COPD exacerbation or Pneumonia; a hospitalization where the participant was admitted for congestive heart failure but received treatment for COPD exacerbation (nebulizer treatment plus steroids) ; or, admitted for symptoms pertaining to COPD and received steroids. A COPD- related ED visit was defined as a visit where the treating physician stated that the visit reason is COPD; or, where the participant was discharged on treatment with oral steroids or on treatment for pneumonia.|Measured at 1 month post 'index-hospitalization'|Data was analyzed for all participants unless: 1) participant died during the 1 month study period (we have to exclude deaths from this analysis because we cannot calculate a full count of hospital or ED visits during the 1 month period if the participant had died before the 1 month have elapsed ) ; 2) participant withdrew from the study.|||COPD-related visits per participant||Standard Deviation|Mean
2612202|NCT02036294|Primary|Mean Change in Patients' Score on the St. George Respiratory Questionnaire Within Each Study Arm|This outcome measures the mean change in patient participants' quality of life as measured by the Saint George's Respiratory Questionnaire (SGRQ) score over the 6 month study period within each study arm.The St. George Respiratory Questionnaire (SGRQ) is a widely used validated disease- specific instrument that measures health-related quality of life. The SGRQ measures, using patient self-report, disease impact on symptoms, patient activity, and daily life. The total score for SGRQ ranges from 0 to 100, with higher scores indicating more limitations. The change in a patient's quality of life was calculated as the difference in their total score at 6 months post index-hospitalization from baseline. A difference of 4 points in total score is considered a clinically meaningful difference.|Baseline to 6 months post index-hospitalization|Not all participants could be reached to complete the survey|||units on a scale||95% Confidence Interval|Mean
2612203|NCT02036294|Primary|Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations and Emergency Department (ED) Visits Per Patient Within Each Study Arm|The primary outcome measure in this study is the mean number of COPD-related hospitalizations and ED visits per patient within each study arm . The number of hospital and ED visits per patient were counted at 6 months post 'index-hospitalization'. Index-hospitalization refers to the hospitalization in which the patient was enrolled into the study. A COPD- related hospitalization was defined as a hospitalization with discharge diagnosis of COPD exacerbation or Pneumonia; a hospitalization where the participant was admitted for congestive heart failure but received treatment for COPD exacerbation (nebulizer treatment plus steroids) ; or, admitted for symptoms pertaining to COPD and received steroids. A COPD- related ED visit was defined as a visit where the treating physician stated that the visit reason is COPD; or, where the participant was discharged on treatment with oral steroids or on treatment for pneumonia.|Measured at 6 months post 'index-hospitalization'|Data was analyzed for all participants unless: 1) participant died during the 6 months study period (we have to exclude deaths from this analysis because we cannot calculate a full count of hospital or ED visits during the 6 months period if the participant had died before the 6 months has elapsed ) ; 2) participant withdrew from the study.|||COPD-related visits per participant||Standard Deviation|Mean
2612204|NCT02035748|Secondary|Mean Nonsurgical Change From Baseline in Central Foveal Thickness (CFT)|Nonsurgical change in central foveal thickness (CFT values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy) was determined by subtracting the measurements in subretinal fluid and retinal pigment epithelium (RPE) elevations and/or SHRM (subretinal hyper-reflective material, such as choroidal neovascularization (CNV)) from the value in total retinal measurement. A lower CFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 28, Day 180|Full Analysis Set. Missing data is imputed using LOCF. CFT values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy.|||micrometers||Standard Deviation|Mean
2612205|NCT02035748|Secondary|Proportion of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180|Pars plana vitrectomy (the surgical removal of vitreous gel from the eye) was captured in Concomitant Ocular Procedures. Proportion of subjects is reported as a percentage. One eye (study eye) contributed to the analysis.|Day 180|Full Analysis Set|||percentage of subjects|||Number
2612206|NCT02035748|Secondary|Proportion of Subjects With Nonsurgical Resolution of VMT/sVMA|Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 90 and Day 180. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 90/Day 180. One eye (study eye) contributed to the analysis.|Baseline, Day 90, Day 180|Full Analysis Set. Missing data imputed using LOCF. Subjects who had vitrectomy after VMT/sVMA resolution were considered as 'no resolution' after the timepoint of vitrectomy.|||percentage of subjects|||Number
2612207|NCT02035748|Secondary|Proportion of Subjects With Nonsurgical Closure of Macular Hole (MH), if Present at Baseline|The closure of macular hole (a full thickness defect of the retinal tissue involving the anatomical fovea) is defined as a flattened and reattached hole rim along the whole circumference of macular hole. Closure was determined by SD-OCT evaluation and the percentage of subjects tabulated. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who had macular hole at baseline and OCT value at each specific visit. One eye (study eye) contributed to the analysis.|Day 28, Day 90, Day 180|Full Analysis Set. Missing data imputed using LOCF. Subjects who had vitrectomy after MH closure were considered as 'no MH closure' after the timepoint of vitrectomy.|||percentage of subjects|||Number
2612208|NCT02035748|Secondary|Nonsurgical Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance|BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters. The charts contain 14 rows of letters. BCVA was calculated as the number of letters read correctly and improvement defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 28, Day 90, Day 180|Full Analysis Set. Missing data imputed using LOCF. BCVA values after a vitrectomy were imputed with the last non-missing value prior to the vitrectomy.|||letters||Standard Deviation|Mean
2612209|NCT02035748|Primary|Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Traction (VMT/VMA) at Day 28, as Determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD‐OCT) Evaluation|Vitreous separation was assessed by SD-OCT using scores ranging from 1 (vitreous attached from macula to ON; separated elsewhere cannot determine foveal) to 12 (unable to determine state of separation). Nonsurgical resolution was defined as a change from baseline score of 5/6/8 to 7/9/10 at Day 28. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. Thus, the term VMA is used interchangeably with VMT/sVMA. Proportion of subjects is presented as a percentage, with percentage based on the number of subjects who have VMT/sVMA at baseline and SD-OCT value at Day 28. One eye (study eye) contributed to the analysis.|Baseline, Day 28|This analysis population includes all subjects who received treatment with IP and had at least one post-treatment measurement of SD-OCT (FAS). Missing data imputed using the last observation carried forward (LOCF) method. Subjects who had vitrectomy after VMT/sVMA resolution were considered as 'no resolution' after timepoint of vitrectomy.|||percentage of subjects|||Number
2612210|NCT02035696|Secondary|Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine|Safety was assessed in terms of number of subjects (6 to <48 months old) reporting unsolicited reactions after Each /any Vaccination from Day 1 [Post Vaccination] to Day 29 [Pre Clinic Visit] and Day 29 [Post Vaccination] to Day 50 [Pre Clinic Visit] , Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases (NOCD), AEs leading to withdrawal from the study and concomitant medications (day 1 to day 209) after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination)|Unsolicited AEs after Each/any Vaccination from Day 1 to Day 29 and Day 29 to Day 50 , Day 1 to Day 209|Analyses was done on unsolicited safety data set i.e. all subjects in the exposed set who have post-vaccination unsolicited AE data|||Subjects|||Number
2612211|NCT02035696|Secondary|Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine|Safety was assessed in terms of number of subjects (6 to <48 months old) reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination)|Day 1 to Day 7|Analyses was done on solicited safety data set. 4 subjects (3 subjects from the TIVe group, and 1 subject from the full dose TIVc group, were excluded from the solicited safety set analyses (6h –day3, day4-day7 and 6h – day 7) as these subjects did not provide any post vaccination solicited safety data|||Subjects|||Number
2612212|NCT02035696|Secondary|Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine|"Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving MN titer ≥1:40 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine~Post-vaccination MN titer ≥1:40 was defined as for subjects with baseline (day 1) MN titer <1:10, or a minimum 4-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI"|Day 1 and Day 50 post vaccination|Analysis was done on PPS|||Percentages of subjects||95% Confidence Interval|Number
2612213|NCT02035696|Secondary|Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine|"Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving MN titer ≥1:20 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine~Post-vaccination MN titer ≥1:20 was defined as for subjects with baseline (day 1) MN titer <1:10, or a minimum 2-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI"|Day 1 and Day 50 post vaccination|Analysis was done on PPS|||Percentage of subjects||95% Confidence Interval|Number
2612214|NCT02035696|Secondary|Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine|Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving post vaccination HI titers (i.e. HI titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine|Day 1 and Day 50 post vaccination|Analysis was done on PPS|||Percentages of subjects||95% Confidence Interval|Number
2612215|NCT02035696|Secondary|Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine|Immunogenicity was assessed in terms of GMR in subjects (6 to <48 months old) as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine|Day 50 post vaccination over day 1|Analysis was done on PPS|||Ratios||95% Confidence Interval|Number
2612216|NCT02035696|Secondary|Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine|"Immunogenicity was assessed in terms of GMR in subjects (6 to <48 months old) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine~The CHMP criterion is mean geometric ratio (GMR) >2.5"|Day 50 post vaccination over day 1|Analysis was done on FAS|||Ratios||95% Confidence Interval|Number
2612217|NCT02035696|Secondary|Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine|"Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving HI titer ≥1:40 as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine~The CBER criterion for pediatric population is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%~The CHMP criterion for pediatric population is that the percentage of subjects achieving HI antibody titers ≥1:40 should be >70%"|Day 1, Day 50 post vaccination|Analysis was done on FAS|||Percentages of subjects||95% Confidence Interval|Number
2612218|NCT02035696|Secondary|Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine|"Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving seroconversion as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine~Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer~The Center for Biologics Evaluation, Research, and Review (CBER) criterion for pediatric population is that the lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%~The Committee for Medicinal Products for Human Use (CHMP) criterion for pediatric population is that the percentage of subjects achieving seroconversion or significant increase in HI antibody titers >40%"|Day 50 post vaccination|Analysis was done on Full analysis set|||Percentages of subjects||95% Confidence Interval|Number
2612219|NCT02035696|Primary|Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine|Differences in percentages of subjects (6 to <48 months old) with severe local solicited AEs and severe solicited systemic AEs, 3 days after vaccination with either TIVc or TIVe vaccine was assessed in terms of an individual desirability index score (High dose, Full dose, Half dose TIVc vs. TIVe vaccine). An individual desirability index score was assigned to each (non-transformed) safety value based on predefined functions. Each desirability index score is assigned a value between 0 and 1, wherein 0 is an undesirable response and 1 is a highly desirable response.|Day 1 to Day 3|Analysis was done on PPSd-All subjects in the FASd who:Correctly received the vaccine (i.e., received the vaccine to which the subjects is randomized and at the scheduled time points).|||percentage of participants|||Number
2612220|NCT02035696|Primary|Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine|Immunogenicity was assessed in terms number (%) of subjects (6 to <48 months old) achieving seroconversion as measured by HI antibody titer, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer|Day 50 post vaccination|Analysis was done on PP population|||Percentages of subjects||95% Confidence Interval|Number
2612221|NCT02035696|Primary|Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine|Immunogenicity was assessed in terms of ratios of GMTs in subjects (6 to <48 months old), measured by hemagglutination inhibition (HI) assay, day 1 to day 50 after vaccination with two doses of either TIVc or TIVe vaccine|Day 50/Day 1|Analysis was done on Per Protocol (PP) population i.e. all subjects in the FAS Efficacy/Immunogenicity Set who are not excluded due to reasons defined prior to unblinding or analysis|||Ratios||95% Confidence Interval|Number
2612222|NCT02035553|Primary|Antipsychotic Efficacy|Change from Baseline to Day 43 in the Neuropsychiatric Inventory-Nursing Home Version (NPI-NH) psychosis score (Delusions [Domain A]+Hallucinations [Domain B]) in the Full Analysis Set (FAS). The NPI-NH is a questionnaire that quantifies behavioral changes in dementia in nursing home patients and evaluates 12 behavioral domains. For each of the 12 behavioral domains the Frequency (scale:1=occasionally to 4=very frequently) is multiplied by the Severity (scale:1=Mild to 3=Severe) to obtain a domain score (frequency x severity), The NPI-NH Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual domain scores, to yield a possible total score of 0 to 24. Lower scores correspond to less severity. A negative change score from baseline indicates improvement.|Day 43|All randomized subjects who received at least one dose of study treatment and have both a Baseline and at least one post-Baseline NPI-NH psychosis score evaluation.|||Score on the NPI-NH scale||95% Confidence Interval|Least Squares Mean
2612225|NCT02035345|Primary|Number of Patients With Carboplatin Reactions of Different Severity|To characterize the nature and symptoms of carboplatin reactions associated with the slowed infusion protocol.|2 Years|Among the 15 patients enrolled, the HSR rate was 40% which occurred after a median of 2 protocol treatments, which prompted early termination of this study.|||participants|||Number
2612226|NCT02035345|Primary|Number of Participants With Carboplatin Infusion Hypersensitivity Reactions Using a Slowed Carboplatin Infusion Program|To determine the frequency of carboplatin infusion hypersensitivity reactions using a slowed carboplatin infusion program|2 Years|Total number of patients in the study that received carboplatin via slowed infusion.|||participants|||Number
2612227|NCT02035332|Post-Hoc|Subjects With Amenorrhea at 12 Months|Amenorrhea at 12 Months- Number of Subjects experiencing no menstrual bleeding|12 Months|Protocol Intent-to-treat|||participants|||Number
2612228|NCT02035332|Secondary|Procedure Time|Procedure time defined as time from insertion of the Disposable Handpiece to the time of removal.|Day of procedure|Subjects completing treatment|||Minutes||Standard Deviation|Mean
2612229|NCT02035332|Primary|Reduction in Menstrual Blood Loss to Normal Levels at 12-months|Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of <=75. A score of 0 represents no bleeding.|12 Months|Protocol Intent-to-treat population (all subjects in whom the experimental device was attempted to be placed.)|||participants|||Number
2612230|NCT02035267|Primary|Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG)|The SMSLG is an integration of three features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds). Each grade (1=none, 2=mild, 3=moderate and 4=severe) defines the maximal allowed limit for skin wrinkling, adherence to underlying structures and redundancy.|Baseline and up to Week 32 (12 weeks after last treatment)|Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug.|||scores on a scale||Standard Deviation|Mean
2612231|NCT02035267|Primary|Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS)|The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).|Baseline and up to Week 32 (12 weeks after last treatment)|Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug. Only subjects with baseline CR-SMFRS grade = 4 were included, since a 2-grade improvement was not anticipated for baseline CR-SMFRS grade = 1 subjects.|||percentage of participants|||Number
2612232|NCT02035267|Primary|Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS)|The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).|Baseline and up to Week 32 (12 weeks after last treatment)|Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug.|||percentage of participants|||Number
2612233|NCT02035267|Primary|Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)|The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).|Baseline and up to Week 32 (12 weeks after last treatment)|Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug. Only subjects with baseline CR-SMFRS grade 4 were included, since a 2-grade improvement was not possible for subjects with baseline CR-SMFRS grade 1.|||percentage of participants|||Number
2612234|NCT02035267|Primary|Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)|The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).|Baseline and up to Week 32 (12 weeks after last treatment)|Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug.|||percentage of participants|||Number
2612235|NCT02035267|Primary|Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments|"The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).~The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst)."|Baseline and up to Week 32 (12 weeks after last treatment)|Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug. Only subjects with baseline CR-SMFRS grade 4 were included, since a 2-grade improvement was not possible for subjects with baseline CR-SMFRS grade 1.|||percentage of participants|||Number
2612236|NCT02035267|Primary|Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments|"The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).~The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst)."|Baseline and up to Week 32 (12 weeks after last treatment)|Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug.|||percentage of participants|||Number
2612270|NCT02034591|Secondary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Apixaban|AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data|||ng*h/mL||90% Confidence Interval|Geometric Mean
2612237|NCT02035202|Other Pre-specified|Dysfunctional Attitudes Scale (DAS)|The DAS is a 40-item self-report subscale indexing maladaptive attitudes, particularly one's ability to perform tasks and one's need for approval from others. The DAS consists of 40 items and each item consists of a statement and each is rated on a 7-point Likert scale (7 = fully agree; 1 = fully disagree). Ten items are reverse coded (items: 2, 6, 12, 17, 24, 29, 30, 35, 37 and 40). The total score is the sum of the 40-items and the range of scores is 40-280, with higher scores indicating more dysfunctional attitudes.|Baseline, mid-point (6 weeks), at post-treatment (12 weeks), 24 week follow up||||units on a scale||Standard Deviation|Mean
2612238|NCT02035202|Secondary|SPECIFIC LEVEL OF FUNCTION (SLOF)|The SLOF is an interviewer rated measure that addresses community function in serious mental illness, utilizing a best estimate approach in which data is integrated from interviewer, informant, and participant responses. The score ranges from 30 to 150. Higher scores equal greater function.|Baseline, 12 weeks, 24 weeks|There was missing data due to lack of available informants for the SLOF so that the number analyzed is less than that associated with the other measures|||units on a scale||Standard Deviation|Mean
2612239|NCT02035202|Primary|Score on the Brief Psychiatric Rating Scale (BPRS)|The BPRS-24 includes 24 items that cover depression, anxiety, mania, suicidality, delusions/hallucinations, and unusual behavior. The BPRS is reliable, valid, and sensitive to change in both bipolar disorder and schizophrenia, and therefore enables the examination of diagnosis as a moderator of treatment effect. Twenty four items are rated on a 1-7 scale from present to severe, and the Total Score will be the primary outcome for analyses. It is clinician rated and the minimum score is 24 and the maximum score is 148 and higher scores reflect worse outcome.|Baseline, 6 weeks, 12 weeks, and 24 weeks||||units on a scale||Standard Deviation|Mean
2612240|NCT02034916|Other Pre-specified|Time to Deterioration in Disease Specific Symptoms as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC-QLQ-BR23)|Time to deterioration was defined as the time from baseline to day to death, first occurrence of progression, or a >=10 point change from baseline in any of the symptom score based on the EORTC-QLQ-BR23, whichever occurred first. EORTC-QLQ-BR23 is a disease-specific module for breast cancer developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer. EORTC-QLQ-BR23 symptoms subscale includes 4 items: systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss. Each item is rated by choosing 1 of 4 possible responses that record the level of intensity (1= not at all, 2= a little, 3= quite a bit, and 4= very much) within each scale.|Baseline up to death, disease progression or end of treatment (30 days after last dose of study drug or before initiation of a new anticancer therapy, whichever occurred first [up to data cutoff date: 01 Sep 2016])|ITT population involved all enrolled participants including participants who were not treated.|||months||95% Confidence Interval|Median
2612241|NCT02034916|Other Pre-specified|Time to Deterioration in Global Health Status/Quality of Life (QOL) and Functional Status as Assessed by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)|Time to deterioration was defined as the time from baseline to day to death, first occurrence of progression, or a >=10 point change from baseline in any of the functional status score and global health status/QOL score based on the EORTC-QLQ-C30, whichever occurred first. EORTC-QLQ-C30 questionnaire is a standardized instrument developed to assess the quality of life of people with cancer. EORTC-QLQ-C30 functional subscale includes 5 items: physical, role, emotional, cognitive, and social functioning. All of the single items of functional status subscale measures and global health status/QOL subscale range from 0 to 100, where higher scores represent a better level of functioning/quality of life.|Baseline up to death, disease progression or end of treatment (30 days after last dose of study drug or before initiation of a new anticancer therapy, whichever occurred first [up to data cutoff date: 01 Sep 2016])|ITT population involved all enrolled participants including participants who were not treated.|||months||95% Confidence Interval|Median
2612242|NCT02034916|Secondary|Trough Concentration Versus Time Summary of Talazoparib|Concentrations below the limit of quantitation values less than or equal to (<=) 25 picogram per milliliter (pg/mL) were set as zero. Pharmacokinetic (PK) analysis was not done separately for each reporting arm and cohorts were combined for PK analysis.|Predose on Day 1 of Cycle 1, 2, 3, and 4 (data cutoff date: 01 Sep 2016)|PK population included all participants who received at least 1 dose of talazoparib and had evaluable PK assessments. Here 'n' signifies participants evaluable for each specified categories.|||pg/mL||Standard Deviation|Mean
2612243|NCT02034916|Secondary|Number of Participants With At Least 1 Concomitant Medication|Number of participants taking any non-study medications, therapies, including herbal supplements during the treatment-emergent period for the management of an adverse event or for the treatment of any other disease.|Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018)|Safety population included all participants who received at least 1 dose of talazoparib.|||Participants|||Count of Participants
2612244|NCT02034916|Secondary|Number of Participants With Clinically Significant Change From Baseline in Physical Findings|Physical examination included examination of the head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.|Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018)|Safety population included all participants who received at least 1 dose of talazoparib.|||Participants|||Count of Participants
2612245|NCT02034916|Secondary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Criteria for clinically significant vital signs changes: 1) Blood pressure: systolic blood pressure (SBP): greater than or equal to (>=30) millimeters of mercury (mmHg) increase from baseline, diastolic blood pressure (DBP): >=20 mmHg decrease from baseline; 2) Heart rate (HR): absolute HR greater than (>) 120 beats per minute (bpm) and >30 bpm increase from baseline, absolute HR less than (<) 50 bpm and >20 bpm decrease from baseline; 3) Weight: >10% decrease from baseline. Number of participants with any clinically significant change from baseline for blood pressure, heart rate and weight are reported in this outcome measure.|Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018)|Safety population included all participants who received at least 1 dose of talazoparib.|||Participants|||Count of Participants
2612246|NCT02034916|Secondary|Number of Participants With Toxicity Grades Increase of 2 or More in Laboratory Parameter (Chemistry Parameter)|Laboratory tests included serum chemistry (alanine aminotransferase [high], albumin [low], alkaline phosphatase [high], aspartate aminotransferase [high], bilirubin [high], calcium [low], glucose [high], magnesium [low], phosphate [low], potassium [high], potassium [low], sodium [high], sodium [low]). Toxicity grades were evaluated based on national cancer institute- common terminology criteria for adverse events (NCI-CTCAE) version 4.03. Number of participants with increase of 2 or more CTCAE toxicity grades above baseline, for chemistry laboratory parameter is reported in this outcome measure.|Baseline up to 30 days after the last dose of study drug or before initiation of a new anticancer treatment, whichever occurred first (up to data cutoff date [01 Sep 2016])|Safety population included all participants who received at least 1 dose of talazoparib.|||Participants|||Count of Participants
2612247|NCT02034916|Secondary|Number of Participants With Toxicity Grades Increase of 2 or More in Laboratory Parameter (Hematology Parameter)|Laboratory tests included hematology (hemoglobin [low], leucocytes [low], lymphocytes [low], neutrophils [low], platelets [low]). Toxicity grades were evaluated based on national cancer institute- common terminology criteria for adverse events (NCI-CTCAE) version 4.03. Number of participants with increase of 2 or more CTCAE toxicity grades above baseline, for hematology laboratory parameter is reported in this outcome measure.|Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018)|Safety population included all participants who received at least 1 dose of talazoparib.|||Participants|||Count of Participants
2612248|NCT02034916|Secondary|Number of Participants With Outcome in Response to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'.|Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018)|Safety population included all participants who received at least 1 dose of talazoparib.|||Participants|||Count of Participants
2612249|NCT02034916|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A treatment-related SAE was a treatment-related AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; an important medical event or reaction, including events requiring medical intervention to prevent worsening to any of the previously noted seriousness criteria. Related TEAEs are TEAEs that were judged by the investigators as possibly, probably, or definitely related to study drug. AEs included both SAES and non SAES.|Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018)|Safety population included all participants who received at least 1 dose of talazoparib.|||Participants|||Count of Participants
2612250|NCT02034916|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; an important medical event or reaction, including events requiring medical intervention to prevent worsening to any of the previously noted seriousness criteria. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs.|Baseline up to end of study (up to a maximum duration of 42.8 months): based on data cutoff date (31 Oct 2018)|Safety population included all participants who received at least 1 dose of talazoparib.|||Participants|||Count of Participants
2612251|NCT02034916|Secondary|Overall Survival (OS)|OS was defined as the time from first dose of study drug to death due to any cause. For participants without a death date at the time of data cutoff or permanently lost to follow-up, OS was right-censored at the date the participant was last known to be alive on or before the data cutoff date.|From first dose of study drug until death due to any cause (up to the data cutoff date [01 Sep 2016])|ITT population involved all enrolled participants including participants who were not treated.|||months||95% Confidence Interval|Median
2612252|NCT02034916|Secondary|Progression Free Survival (PFS)|PFS was defined as the time in months from the first dose of study drug to the first documentation of PD by investigator assessment using RECIST 1.1 or death on study due to any cause on or before the data cutoff date, whichever occurred first. PD: >=20% increase (>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions. Participants with no PFS event at the analysis were censored at last tumor assessment date prior to data cutoff or date of new anticancer treatment initiation, whichever occurred first.|From first dose of study drug until PD, last tumor assessment without PD before new anticancer treatment initiation or death due to any cause, whichever occurred first (up to the data cutoff date [01 Sep 2016])|ITT population involved all enrolled participants including participants who were not treated.|||months||95% Confidence Interval|Median
2612271|NCT02034591|Secondary|Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban|Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data|||ng/mL||90% Confidence Interval|Geometric Mean
2612272|NCT02034591|Primary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban|AUC(0-T) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data|||ng*h/mL||90% Confidence Interval|Geometric Mean
2612552|NCT02032420|Secondary|Needle-not-seen Time|Median percentage of attempt time on 3 iterations in which the needle is not adequately visualized, across participants within a study arm|During attempt||||percentage of attempt time||Inter-Quartile Range|Median
2612253|NCT02034916|Secondary|Duration of Response (DOR)|DOR: Time from first documentation of CR or PR, to PD by IRF assessment using RECIST 1.1, or to death due to any cause, whichever occurred first. CR: Disappearance of all non-nodal target and non-target lesions, with target and non-target lymph nodes reduction to <10 mm in short axis. PR: >=30% decrease in sum of diameters of target lesions, compared to the sum at baseline. PD: >=20% increase (>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions. Participants with no PD or death at the analysis date were censored at last tumor assessment date prior to on or before initiation of a new anticancer therapy or before the data cutoff date.|From first documentation of CR or PR until PD, last tumor assessment without PD before new anticancer treatment initiation or death due to any cause, whichever occurred first (up to the data cutoff date [01 Sep 2016])|TEP included all treated participants who had a baseline and at least 1 post-baseline tumor assessment or who discontinued the study before first scheduled post-baseline tumor scan + 1 week window. Here 'Number of participants analyzed' signifies participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2612254|NCT02034916|Secondary|Clinical Benefit Rate-24 (CBR-24)|CBR24: Percentage of participants with a best response of CR, PR or stable disease (SD) sustained for at least 24 weeks, as assessed by IRF using RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to <10 mm in short axis. PR: >=30% decrease in sum of diameters of target lesions, compared to the sum at baseline. SD: Neither PR nor progression of disease (PD) criteria met. SD follow PR only when sum increases by less than 20% from the nadir, but previously seen 30% decrease from baseline no longer hold. PD: >=20% increase (>=5 mm absolute increase) in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), or unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions.|From randomization until data cutoff date (01 Sep 2016)|TEP included all treated participants who had a baseline and at least 1 post-baseline tumor assessment or who discontinued the study before first scheduled post-baseline tumor scan + 1 week window.|||percentage of participants||95% Confidence Interval|Number
2612255|NCT02034916|Primary|Objective Response Rate (ORR)|ORR: Percentage of participants with a confirmed best overall complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors version 1.1 (RECIST 1.1). CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to less than (<) 10 millimeter (mm) in short axis. PR: Greater than or equal to (>=) 30 percent (%) decrease in sum of diameters of target lesions, compared to the sum at baseline. Response evaluation was done by an independent radiology facility (IRF).|From randomization until data cutoff date (01 Sep 2016)|Tumor-evaluable population (TEP) included all treated participants who had a baseline and at least 1 post-baseline tumor assessment or who discontinued the study before first scheduled post-baseline tumor scan plus (+) 1 week window.|||percentage of participants||95% Confidence Interval|Number
2612256|NCT02034877|Primary|Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination|Percentage of participants achieving serotype-specific pneumococcal OPA titer >=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|1 month after 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.|||Percentage of participants||95% Confidence Interval|Number
2612257|NCT02034877|Primary|Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination|Percentage of participants achieving serotype-specific pneumococcal OPA titer >=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|Before 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.|||Percentage of participants||95% Confidence Interval|Number
2612258|NCT02034877|Primary|Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination|GMFRs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC vaccination to 1 month after 13vPnC vaccination were computed using the logarithmically transformed assay results. CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before and after vaccination blood draws. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|Before 13vPnC vaccination, 1 month after 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.|||Fold rise||95% Confidence Interval|Geometric Mean
2612259|NCT02034877|Primary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination|Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%. For each serotype, GMTs were calculated using the logarithmically transformed assay results. CIs for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|1 month after 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.|||Titers||95% Confidence Interval|Geometric Mean
2612260|NCT02034877|Primary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination|Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50 percent (%). For each serotype, GMTs were calculated using the logarithmically transformed assay results. Confidence intervals (CIs) for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.|Before 13vPnC vaccination|Evaluable immunogenicity population: eligible participants received 13vPnC;had blood drawn within pre-specified time-frames with at least 1 valid,determinate assay result,no major protocol violation. Only 400 adults were selected for immunogenicity analysis, ‘n’=number of participants with valid and determinate assay results for specified serotype.|||Titers||95% Confidence Interval|Geometric Mean
2612261|NCT02034877|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 1 month after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Within 1 month after 13vPnC vaccination|Safety population included all participants who received 1 dose of 13vPnC vaccination.|||Percentage of participants|||Number
2612262|NCT02034799|Secondary|Incidence of Potential Bleeding-related Adverse Events||Through 30-day follow-up||||participants|||Number
2612263|NCT02034799|Secondary|Incidence of Neurosurgical Complications, Central Nervous System Events and Surgical Wound Complications.||Through 30-day follow-up||||participants|||Number
2612264|NCT02034799|Secondary|Hemostasis at the TBS at 3 Minutes Following Treatment Application|The percentage of participants with hemostasis at the Target Bleeding Site (TBS) at 3 minutes following start of treatment application. Hemostasis was defined as no detectable bleeding at the TBS.|Intra-operative, 3 minutes following randomization||||% of participants||95% Confidence Interval|Number
2612265|NCT02034799|Primary|Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS.|The percentage of participants with hemostasis at the Target Bleeding Site (TBS) at 6 minutes following start of treatment application. Hemostasis is defined as no detectable bleeding at the TBS.|Intra-operative, 6 minutes following randomization||||% of participants||95% Confidence Interval|Number
2612266|NCT02034708|Primary|Percentage of Patients With Overall Lesion Visualization and Characterization Scored as Good or Excellent|"Overall lesion visualization and characterization, based on assessment of the primary or largest lesion if there is more than one lesion present, was assessed by 3 independent off-site readers on a 4-point scale:~0. Poor: does not allow adequate visualization and characterization of the lesion; 1. Fair: allows partial visualization and characterization of the lesion ; 2. Good: allows adequate visualization and characterization of the lesion; 3. Excellent: allows excellent visualization and characterization of the lesion."|Up to 15 days after randomization|Patients with at least one valid assessment of the primary outcome and without major protocol deviation|||percentage of patients|||Number
2612267|NCT02034591|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked laboratory abnormalities were defined as laboratory assessments meeting the following investigator-specified criteria: Leukocytes >1.2* upper limits of normal (ULN) , Basophils >3%, Eosinophils >1.5*ULN, Blood Urine >=2, Red Blood Cell (RBC) Urine >=2, White Blood Cell (WBC) Urine >=2|Day 1 to 30 days after last dose of study drug|All randomized participants|||participants|||Number
2612268|NCT02034591|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths or Discontinuation of Study Drug Due to AEs|AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0|Day 1 to 30 days after last dose of study drug|All randomized participants|||participants|||Number
2612269|NCT02034591|Secondary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban|AUC(0-T) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data|||ng*h/mL||90% Confidence Interval|Geometric Mean
2612273|NCT02034591|Primary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinite Time AUC(INF) of Apixaban|AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available PK data|||ng*h/mL||90% Confidence Interval|Geometric Mean
2612274|NCT02034591|Primary|Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban|Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose for each intervention|All randomized participants with available pharmacokinetic (PK) data|||ng/mL||90% Confidence Interval|Geometric Mean
2612275|NCT02034578|Secondary|Number of Participants With Marked Abnormality in Hematology, Chemistry and Urinalysis Laboratory Tests|Participants were required to fast for at least 10 hours prior to the collection of specimens for clinical laboratory tests. Tests were performed at Screening, Day -1, and Day 4 of each period 1 - 3. Leukocyte criteria: Lower limits of normal (LLN), upper limits of normal (ULN), pre-treatment (preRX). Low Leukocytes: if value < 0.9*LLN, or if preRX < LLN then use < 0.85* preRX. High lymphocytes: if value > 7.500 10^3 cells/ µL. Low neutrophils plus bands: if value <= 1.500 10^3 cells/µL. High creatine kinase: if value > 1.5* ULN. Blood in urine: if value >= 2 plus, or if preRX >= 1 plus then use >= 2*preRX.|Screening, Day -1, Day 4 of Periods, 1, 2, and 3|Participants who received study drug were analyzed.|||participants|||Number
2612276|NCT02034578|Secondary|Number of Participants With Clinically Significant Electrocardiogram, Vital Sign, or Physical Examination Findings|12-lead electrocardiograms (ECGs) and Vital Signs were performed at Screening, and Day 1 of Periods 1, 2 and 3 (pre-dose and prior to NGT placement, if done). Vital signs and ECGs were also performed on Day 4 of Period 3, prior to discharge from the study. Vital signs included body temperature, respiratory rate, seated blood pressure and heart rate. Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes. Participants had physical examinations on Period 1, Day 1 (pre-dose) and Day 4 of Period 3, prior to study discharge.|Screening, Day 1 of Periods, 1, 2, and 3, and Day 4 of Period 3|All participants who received study drug were analyzed.|||participants|||Number
2612277|NCT02034578|Secondary|Mean Plasma Elimination Half-Life (T-HALF) of Apixaban|Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. T-HALF was measured in hours (h).|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3|All participants who received study drug and had adequate PK profiles were included in the analysis.|||h||Standard Deviation|Mean
2612278|NCT02034578|Secondary|Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time, AUC(INF), of Apixaban|Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. AUC(0-INF) was measured in ng*h/mL.|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3|All participants who received study drug and had adequate PK profiles were included in the analysis.|||ng*h/mL||90% Confidence Interval|Geometric Mean
2612279|NCT02034578|Secondary|Adjusted Geometric Mean Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Plasma Concentration, AUC(0-T), of Apixaban|Samples of plasma from participants were obtained at the following times: 0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. AUC(0-T) was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3|All participants who received study drug and had adequate PK profiles were included in the analysis.|||ng*h/mL||90% Confidence Interval|Geometric Mean
2612280|NCT02034578|Secondary|Median Time of Maximum Observed Plasma Concentration (Tmax) of Apixaban|Samples of plasma from participants were obtained at the following times: 0 hour (h), 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h, relative to the single dose on Day 1 in each cross over period. Apixaban was assayed using a validated LC-MS/MS method during the period of known analyte stability. Maximum observed plasma concentration (Tmax) was measured in hours (h).|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3||||h||Full Range|Median
2612281|NCT02034578|Primary|Adjusted Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Apixaban|Samples of plasma from participants were obtained at the following times: 0 hour (h) and post dose at 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h. Apixaban was assayed using a validated Liquid chromatography tandem mass spectrometry (LC-MS/MS) method during the period of known analyte stability. Maximum observed plasma concentration (Cmax) was measured in nanograms per milliliter (ng/mL).|Day 1 (0 h, 0.25h, 0.50h, 1h, 2h, 3h, 4h, 5h, 6h, 9h, 12h, 24h, 36h, 48h, 60h, and 72h post dose) in Periods 1, 2 and 3|All participants who received study drug and had adequate PK profiles were included in the analysis.|||ng/mL||90% Confidence Interval|Geometric Mean
2612282|NCT02034578|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Death|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to Day 12|All participants who received study drug were analyzed.|||participants|||Number
2612297|NCT02034513|Secondary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c (glycosylated haemoglobin) at week 32 (treatment period 1) and at week 64 (treatment period 2). Week 32 HbA1c absolute value was considered as baseline for calculating change from baseline in HbA1c at week 64.|Week 32, Week 64|Both descriptive analysis and statistical analysis were based on the FAS. Here, 'n' specifies the number of subjects with available data at specified time-point.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
2612283|NCT02034565|Secondary|Number of Participants With Marked Laboratory Abnormalities|Clinical laboratory tests were performed pre-study and at selected times throughout the study. Marked laboratory abnormalities were defined as laboratory assessments meeting the following investigator-specified criteria: Leukocytes < 0.9* lower limits of normal (LLN), absolute neutrophils + bands <= 1.500 10*3 cells/microliter, white blood cells (WBC) urine value >= 2+. These laboratory abnormalities were not considered clinically significant and therefore not adverse events.|Pre-study screen (Day -1) to Day 8 or day of study discharge|All treated participants|||participants|||Number
2612284|NCT02034565|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related Adverse Events (AEs), Deaths or Discontinuation of Study Drug Due to AEs|AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v13).|Day 1 to 30 days after last dose of study drug|All treated participants|||participants|||Number
2612285|NCT02034565|Primary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Apixaban|Serial blood samples for pharmacokinetic analysis were collected at selected times up to 72 hours after each dose. AUC(0-T) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose per intervention|All treated participants with available pk data|||ng*h/mL||90% Confidence Interval|Geometric Mean
2612286|NCT02034565|Primary|Adjusted Geometric Mean of the Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinite Time AUC(INF) of Apixaban|Serial blood samples for pharmacokinetic analysis were collected at selected times up to 72 hours after each dose. AUC(INF) is measured in nanogram hours per milliliter (ng*h/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose per intervention|All treated participants with available pk data|||ng*h/mL||90% Confidence Interval|Geometric Mean
2612287|NCT02034565|Primary|Adjusted Geometric Mean of the Maximum Observed Plasma Concentration (Cmax) of Apixaban|Serial blood samples for pharmacokinetic analysis were collected at selected times up to 72 hours after each dose. Maximum observed plasma concentration (Cmax) is measured in nanograms per milliliter (ng/mL)|Pre-dose and 0.25, 0.50, 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60, 72 hours post-dose per intervention|All treated participants with available pharmacokinetic (pk) data|||ng/mL||90% Confidence Interval|Geometric Mean
2612288|NCT02034552|Secondary|Overall Survival||From the randomization date to the date of death due to any cause (about 42.94 months)|MITT analysis set: Included all ITT subjects who received at least one dose of each study drug as randomized.|||Months||80% Confidence Interval|Median
2612289|NCT02034552|Secondary|Symptomatic Skeletal Event-free Survival||From the randomization date to the first SSE on or following the randomization date or death, whichever occurred first (about 32.39 months)|MITT analysis set: Included all ITT subjects who received at least one dose of each study drug as randomized.|||Months||80% Confidence Interval|Median
2612290|NCT02034552|Secondary|Time to First Symptomatic Skeletal Event||From the randomization date to the first SSE on or following the randomization date (about 30.82 months)|MITT analysis set: Included all ITT subjects who received at least one dose of each study drug as randomized.|||Months||80% Confidence Interval|Median
2612291|NCT02034552|Secondary|Time to Radiological Bone Progression||From the randomization date to the date of radiological bone progression (about 30.82 months)||||Months||80% Confidence Interval|Median
2612292|NCT02034552|Secondary|Time to Radiological Progression||From the randomization date to the date of radiological disease progression (about 30.82months)||||Months||80% Confidence Interval|Median
2612293|NCT02034552|Secondary|Radiological Progression Free Survival||From randomization to radiological disease progression or death from any cause (about 30.82 months )|MITT analysis set: Included all ITT subjects who received at least one dose of each study drug as randomized.|||Months||80% Confidence Interval|Median
2612294|NCT02034552|Primary|Bone Scan Lesion Area|Bone scan lesion area was defined as the sum of the pixel areas (cm2) of the set of the whole body technetium-99 bone scan imaging pixels identified as bone lesion.|At 24 weeks|Imaging endpt analysis set (IMG): consists of mITT subj. (ITT subj. who received at least one dose of each study drug as randomized) with evaluable imaging scan at baseline, eg. bl quantitated technetium-99 bone scan imaging of sufficient completeness and quality to be assessable and having a non-zero BSLA, as determ. by the central reviewer.|||cm^2||Standard Deviation|Mean
2612295|NCT02034552|Primary|Patient Bone Scan Response Rate|Radiological bone scan response based on change from baseline of digitized technetium-99 bone scans using computer-aided detection software. Responder (R): 30% or greater resolution of the BSLA compared to baseline. Stable Disease (SD): Not meeting the criteria for R, PD, or UE. Progressive Disease (PD): Two or more new areas of radiotracer uptake attributable to metastatic disease in regions of bone that had not previously shown radiotracer uptake or greater than 30% increase from baseline in BSLA attributable to metastatic disease. Unable to Evaluate (UE): Assigned if bone scan results cannot be interpreted due to inconsistent image acquisition parameters compared to the reference scan, incomplete imaging, or other similar technical deficiencies.|At 24 weeks|Imaging endpt analysis set (IMG): consists of mITT subj. (ITT subj. who received at least one dose of each study drug as randomized) with evaluable imaging scan at baseline, eg. bl quantitated technetium-99 bone scan imaging of sufficient completeness and quality to be assessable and having a non-zero BSLA, as determ. by the central reviewer.|||Percentage|||Number
2612296|NCT02034513|Secondary|FPG (Fasting Plasma Glucose)|Fasting plasma glucose values at week 32 and week 64.|Week 32 and Week 64|Results are based on the FAS. Here, 'n' specifies the number of subjects with available data at specified time-point.|||mmol/L||Standard Deviation|Mean
2612298|NCT02034513|Secondary|Incidence of Treatment Emergent Adverse Events|Treatment emergent adverse event was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|During 32 weeks of treatment for each treatment period|The trial followed a cross over design. Results are based on the SAS.|||Event|||Number
2612299|NCT02034513|Secondary|Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period|Percentage of subjects who experienced one or more severe hypoglycaemic episodes during the maintenance period. Severe hypoglycaemia (according to the American Diabetes Association 2013 definition): A hypoglycaemic episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose values may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.|After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|The trial followed a cross over design. Descriptive analysis was based on the SAS. Number of subjects analysed=subjects in the SAS, who were exposed in at least one maintenance period.|||Percentage of subjects|||Number
2612300|NCT02034513|Secondary|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episodes During the Maintenance Period|Severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia and with time of onset between 00:01 and 05.59 a.m., both inclusive. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|The trial followed a cross over design. Descriptive analysis was based on the SAS. Number of subjects analysed=subjects in the SAS, who were exposed in at least one maintenance period.|||Event|||Number
2612301|NCT02034513|Primary|Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period|Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Maintenance period: 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64).|A 16-week treatment period.|The trial followed a cross over design. Descriptive analysis was based on the safety analysis set (SAS: subjects receiving at least 1 dose of the investigational product, IDeg or its comparator, IGlar). Number of subjects analysed=subjects in the SAS, who were exposed in at least one maintenance period.|||Event|||Number
2612302|NCT02034474|Other Pre-specified|Relationship Between Baseline IL-6 Levels and Positive, Negative and Cognitive Symptoms and Impairment|Comparison of cytokines, in particular IL-6 levels and the positive, negative and cognitive symptoms and impairments in daily functioning in schizophrenia. These outcomes will be measured by Positive and Negative Syndrome Scale (PANSS), Global Assessment of Functioning (GAF), Clinical Global Impression (CGI), University of California Performance Skills Assessments (UPSA) and MATRICS.|Baseline (start of tocilizumab) through 12 weeks|||||||
2612303|NCT02034474|Secondary|Cognitive Symptomatology - UPSA-B Score Change|At Baseline and Week 12, participants are UPSA-B given items reflecting ability to complete tasks encountered in daily life, across two domains, Financial Skills and Communication Skills. % correct is calculated for each domain and converted to a standardized score from 0-50. These scores are summed to produce a total summary score ranging from 0-100. The outcome is the difference between this summary score at Baseline and Week 12, with a higher difference score reflecting a greater increase in functional capacity.|Baseline (start of tocilizumab) through 12 weeks|These subjects were included in the ITT analysis and received the UPSA at both baseline and week 12.We will present total composite change scores from baseline to week 12|||Change in score on a scale||Standard Deviation|Mean
2612304|NCT02034474|Secondary|Cognitive Symptomatology - Overall MATRICS t Score Change|MATRICS cognitive consensus battery, overall t score change. The composite T-score at each time point (baseline and week 12) is a T-Score (ranging from 0 to 100) reflecting overall neuropsychological function, aggregated from the participant's T-scores on the MATRICS subscales for Speed of Processing, Attention/Vigilance, Working Memory, Verbal Learning, Visual Learning, Reasoning and Problem Solving, and Social Cognition. The outcome is the difference between overall composite T-score at baseline and week 12, with higher difference score reflecting a greater improvement in neuropsychological performance.|Baseline (start of tocilizumab) through 12 weeks|These subjects were included in the ITT analysis and received the MATRICS. We will present total composite change scores from baseline to week 12|||T Score Difference||Standard Deviation|Mean
2612305|NCT02034474|Primary|Clinical Response to Tocilizumab|To evaluate an anticipated clinical response to tocilizumab treatment including positive, negative and cognitive symptoms by the change in the Positive and Negative Syndrome Scale (PANSS) total score. Score ranges from 30 to 210 for PANSS total, 16-112 for General, 7-49 for positive and 7-49 for negative symptoms subscales. A lower score means less symptomatic. There is a total score and general psychopathology scores, a positive symptoms score and a negative symptom score. The unit of measure is units on a scale from 1-7, whole numbers only. Summed scores are simply added to each other|Baseline (start of tocilizumab) through 12 weeks. We present the change scores|17 placebo patients and 19 tocilizumab patients were included in the ITT analysis|||Units on a scale (PANSS)||Standard Deviation|Mean
2612306|NCT02034175|Primary|Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI)|AHI is the number of apneas and hypopneas that occur over an hour during the course of the night. The SomnaPatch and PSG were wore simultaneously over the night. The results from the SomnaPatch and PSG were compared per individual for agreement|1 night|12 participants were excluded due to poor quality of sleep data or technical issues during the night. Sleep data was unable to be scored.|||percentage of device agreements||95% Confidence Interval|Number
2612307|NCT02034162|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-last) of Mebendazole|The (AUC [0-last]) is the area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration.|Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)|PK population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure.|||ng*h/mL||Standard Deviation|Mean
2612553|NCT02032420|Primary|Task Completion Time|Median time taken to complete 3 iterations of the assigned task, across participants within a study arm|Immediately after training||||seconds||Inter-Quartile Range|Median
2612308|NCT02034162|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours (AUC8h) of Mebendazole|The (AUC8h) is the area under the plasma concentration-time curve from time 0 to 8 hours Post-dose.|Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)|PK population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure.|||nanogram hour per Milliliters(ng*h/mL)||Standard Deviation|Mean
2612309|NCT02034162|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Mebendazole|The Time to Reach Maximum Plasma Concentration (Tmax) is time to reach the maximum plasma concentration.|Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)|PK population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure.|||hours||Full Range|Mean
2612310|NCT02034162|Primary|Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Open-Label Treatment Period|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|At Visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3)|The open-label follow-up safety analysis set consisted of all randomized participants who received a 500-mg chewable tablet of mebendazole at Visit 3. Here 'N' signifies number of participants analysed for this outcome measure.|||participants|||Number
2612311|NCT02034162|Secondary|Maximum Plasma Concentration (Cmax) of Mebendazole|The Cmax is the maximum plasma concentration.|Predose, 1, 2, 3, 5, 8 and 24 hours postdose at visit 4 (Day 20; 1 day after Visit 3)|Pharmacokinetic (PK) population included all randomized participants who received at least 1 dose of the study drug and had valid pharmacokinetic profile. Here 'N' signifies number of participants analysed for this outcome measure.|||nanogram per Milliliters (ng/mL)||Standard Deviation|Mean
2612312|NCT02034162|Secondary|Egg Count Reduction Rate (Percent) for Trichuris Trichiura Infestation at the End of Double-blind Treatment Period|Percent egg count reduction is calculated as average egg count at end of treatment period of a treatment group minus average egg count at baseline of the treatment group divided by average egg count at baseline of the treatment group.|Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period|The ITT analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure.|||percent change in egg count|||Number
2612313|NCT02034162|Secondary|Egg Count Reduction Rate (Percent) for Ascaris Lumbricoides Infestation at the End of Double-blind Treatment Period|Percent egg count reduction is calculated as average egg count at end of treatment period of a treatment group minus average egg count at baseline of the treatment group divided by average egg count at baseline of the treatment group.|Baseline and Day 19 (Visit 3) at the End of Double-blind Treatment Period|The ITT analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure.|||percent change in egg count|||Number
2612314|NCT02034162|Primary|Number of Participants Reporting Treatment Emergent Adverse Event (TEAE) in Double-Blind Treatment Period|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to Visit 3 (Day 19 +/-2)|The safety analysis set consisted of all randomized participants who received 1 dose of study agent (mebendazole or placebo) at baseline. Here 'N' signifies number of participants analysed for this outcome measure.|||participants|||Number
2612315|NCT02034162|Primary|Cure Rate for Trichuris Trichiura at the End of Double-blind Treatment Period|Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline.|At Visit 3 (Day 19) of Double-blind treatment period|The ITT analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2612316|NCT02034162|Primary|Cure Rate for Ascaris Lumbricoides at the End of Double-blind Treatment Period|Cure is defined as a post-treatment egg count of zero in participants who had a positive egg count at baseline.|At Visit 3 (Day 19) of Double-blind treatment period|The intent-to-treat (ITT) analysis set included all randomized participants with a pretreatment stool sample positive for 1 or more worms of interest. Here 'N' signifies number of participants analysed for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2612317|NCT02034123|Secondary|Part 2: Percentage of Participants Achieving CR and PR|Overall response rate is defined as percentage of participants achieving CR and PR per RECIST version 1.1. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 2 years|All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.||||||
2612318|NCT02034123|Secondary|Part 2: Progression Free Survival (PFS)|PFS is defined as the interval between the first dose of study medication and the earliest date of disease progression or death due to any cause. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 2 years|All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.||||||
2612319|NCT02034123|Secondary|Part 2: Duration of Response|Duration of response for participants is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression or death due to any cause. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 2 years|All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.||||||
2612566|NCT02032212|Primary|Area Under the Concentration-time Curve for Plasma Nicotine (AUCt)||1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours||||min*ng/ml||Geometric Coefficient of Variation|Geometric Mean
2612320|NCT02034123|Secondary|Part 2: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and AUC (0 to Infinity)|The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was planned to be characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Baseline and Up to 2 years|Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.||||||
2612321|NCT02034123|Secondary|Part 2: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and Cmax|The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was planned to be characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Baseline and up to 2 years|Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.||||||
2612322|NCT02034123|Secondary|Part 2: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and Dose|The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was planned to be characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Baseline and up to 2 years|Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.||||||
2612323|NCT02034123|Secondary|Part 2: Volume of Distribution Following Administration of GSK2879552|Blood samples were planned to be collected for population pharmacokinetic analysis of GSK2879552 including volume of distribution. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Pre-dose, 0.5, and 3 hours post-dose on Day 1; Pre-dose on Day 8; Pre-dose, 0.5 to 1 hour, and 4 to 6 hours on Day 15; Pre-dose at Day 22 and up to every 4 weeks until Week 48|Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.||||||
2612324|NCT02034123|Secondary|Part 2: Clearance Following Administration of GSK2879552|Blood samples were planned to be collected for population pharmacokinetic analysis of GSK2879552 including clearance. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Pre-dose, 0.5, and 3 hours post-dose on Day 1; Pre-dose on Day 8; Pre-dose, 0.5 to 1 hour, and 4 to 6 hours on Day 15; Pre-dose at Day 22 and up to every 4 weeks until Week 48|Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.||||||
2612325|NCT02034123|Secondary|Part 2: Number of Participants With Abnormal Findings Undergoing Physical Examinations|The complete physical examination includes assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities. A brief physical examination includes assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 2 years|All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.||||||
2612326|NCT02034123|Secondary|Part 2: Number of Participants With Abnormal Findings for ECG Parameters|Single measurements of 12-lead ECGs were planned to be obtained in a semi-recumbent or supine position after at least a 5 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 2 years|All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.||||||
2612327|NCT02034123|Secondary|Part 2:Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug|Vital sign measurement includes SBP, DBP, temperature, respiration rate and heart rate. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 2 years|All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.||||||
2612328|NCT02034123|Secondary|Part 2: Number of Participants With Change in Hematology Toxicity Grade From Baseline|Blood samples were planned to be collected for the analysis of hematology parameters including hemoglobin, lymphocytes, total neutrophils, platelet count and white blood cell (WBC) count. Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Baseline and up to 2 years|All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.||||||
2612329|NCT02034123|Secondary|Part 2: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline|Blood samples were planned to be collected for evaluation of clinical chemistry parameters including potassium, aspartate aminotransferase (AST), total bilirubin, creatinine, ALT, uric acid, glucose, GGT, albumin, sodium, calcium, alkaline phosphatase, and phosphorus inorganic. Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Baseline and up to 2 years|All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.||||||
2612330|NCT02034123|Secondary|Part 2: Number of Participants Withdrawn Due to Toxicities|Participants were planned to be monitored from start of the study till the development of toxicity in Part 2. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 2 years|All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.||||||
2612331|NCT02034123|Secondary|Part 2: Number of Participants With Dose Reduction or Delays|The number of participants who had any dose reduction or delay were planned to be analyzed. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 2 years|All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.||||||
2612332|NCT02034123|Secondary|Part 2: Number of Participants With DLTs|An event was considered a DLT if it occured within the first 28 days of treatment, and meets one of the following criteria unless it can be clearly established that the event is unrelated to treatment: recurrent Grade 3 anemia after initial transfusion or Grade 3 anemia lasting > 7 days in participants who are not transfused, Grade 4 neutropenia, Grade 3 neutropenia > 7 days duration, febrile neutropenia as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, Grade 3 thrombocytopenia requiring dose reduction, Grade 4 thrombocytopenia lasting > 3 days or of any duration if associated with clinically significant bleeding, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 2 toxicity (at any time during treatment) and treatment delay of 14 days or greater due to unresolved drug-related toxicity. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 2 years|All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.||||||
2612333|NCT02034123|Secondary|Part 2: Number of Participants With SAEs and Non-SAEs|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Up to 2 years|All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.||||||
2612334|NCT02034123|Secondary|Part 1: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and AUC (0 to Infinity)|The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. Only dose cohorts with repeat daily dosing were included in the analysis of platelet as a pharmacodynamic effect. Estimates and standard error have been presented.|Baseline and median of 7.286 weeks of drug exposure|Pharmacokinetic Population|||Hour*Nanogram per milliliter||Standard Error|Mean
2612335|NCT02034123|Secondary|Part 1: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and Cmax|The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was characterized by linear and/or non-linear mixed effect models. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. Only dose cohorts with repeat daily dosing were included in the analysis of platelet as a pharmacodynamic effect. Estimates and standard error have been presented.|Baseline and median of 7.286 weeks of drug exposure|Pharmacokinetic Population|||Nanogram per milliliter||Standard Error|Mean
2612336|NCT02034123|Secondary|Part 1 :Median Effective Dose (ED50) of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and Dose|The pharmacokinetic/pharmacodynamic relationship of GSK2879552 administered orally was characterized by linear and/or non-linear mixed effect models. Only dose cohorts with repeat daily dosing were included in the analysis of platelet as a pharmacodynamic effect. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Percentage change from Baseline was defined as post-dose visit value minus Baseline value, divided by Baseline value and multiplied by 100. Estimates and standard error have been presented.|Baseline and median of 7.286 weeks of drug exposure|Pharmacokinetic Population|||Milligrams||Standard Error|Mean
2612337|NCT02034123|Secondary|Part 1: Number of Participants Achieving Disease Control Rate at Week 16|The clinical activity of GSK2879552 given orally in participants with SCLC was evaluated by assessing disease control rate. Clinical response was assessed by the investigator using computer tomography or magnetic resonance imaging scans. Clinical response was defined as disease control rate (CR+PR+SD) based on RECIST version 1.1 at Week 16. Disease control rate was defined as number of participants achieving CR, PR and SD per RECIST version 1.1. The number of participants achieving disease control rate have been presented.|Week 16|All Treated Population.|||Participants|||Number
2612338|NCT02034123|Secondary|Part 1: Time Invariance Ratio Following Administration of GSK2879552|Time invariance was assessed to evaluate whether the pharmacokinetics remains unaltered after repeat dosing. The mixed effect model was fitted with day as a fixed effect and participant as a random effect for each treatment (dose) separately. AUC (0-tau) on Day 15 was compared to AUC (0-infinity) on Day 1 in order to assess time invariance for each dose. The ratio and 90 percent CI were calculated by back-transforming the difference between the LS means for the two days and associated 90 percent CI, for each dose. Only dose cohorts with repeat daily dosing were analyzed.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15|Pharmacokinetic Population. Only those participants with data available at specific time point were analyzed.|||Ratio of AUC||90% Confidence Interval|Number
2612339|NCT02034123|Secondary|Part 1: Accumulation Ratio Following Administration of GSK2879552|The accumulation ratio was analyzed using analysis of variance (ANOVA) for AUC (0-tau) on Day 15 versus AUC (0-tau) on Day 1 by dose cohort. Only dose cohorts with repeat daily dosing were analyzed. The observed accumulation ratio (Ro) was determined based on AUC data to estimate the extent of accumulation after repeat dosing. The Ro of GSK2879552 was estimated by calculating the ratio of the geometric least squares (GLS) means of the pharmacokinetic parameter between Day 15 and Day 1 for all dose levels and the corresponding 90 percent confidence interval (CI) for each ratio.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15|Pharmacokinetic Population. Only those participants with data available at specific time point were analyzed.|||Ratio of AUC||90% Confidence Interval|Number
2612340|NCT02034123|Secondary|Part 1: Apparent Terminal Phase Half-life (T1/2) Following Single and Repeat Dose Administration of GSK2879552|Blood samples were collected from participants for pharmacokinetic analysis including T1/2 following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available. The data for Day 15 was not computed due to the long half-life of GSK2879552. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15|Pharmacokinetic Population|||Hours||Geometric Coefficient of Variation|Geometric Mean
2612341|NCT02034123|Secondary|Part 1: Apparent Terminal Phase Elimination Rate Constant (Lambda z) Following Single and Repeat Dose Administration of GSK2879552|Blood samples were collected from participants for pharmacokinetic analysis including lambda z following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available. The data for Day 15 was not computed due to the long half-life of GSK2879552 . Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15|Pharmacokinetic Population|||Hours^-1||Geometric Coefficient of Variation|Geometric Mean
2612342|NCT02034123|Secondary|Part 1: Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of GSK2879552|Blood samples were collected from participants for pharmacokinetic analysis including Tmax following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Tmax is the time to reach Cmax, determined directly from the concentration-time data. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15|Pharmacokinetic Population|||Hours||Geometric Coefficient of Variation|Geometric Mean
2612343|NCT02034123|Secondary|Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of GSK2879552|Blood samples were collected from participants for pharmacokinetic analysis including Cmax following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15|Pharmacokinetic Population|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2612344|NCT02034123|Secondary|Part 1: Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0-tau]) Following Repeat Dose Administration of GSK2879552|Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-tau) following repeat (Day 15) dose administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Day 15|Pharmacokinetic Population. Only those participants with data available at specific time point were analyzed.|||Hour*Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2612345|NCT02034123|Secondary|Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of GSK2879552|Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-infinity) following single (Day 1) dose administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. NA represents data was not available.|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1|Pharmacokinetic Population. Only those participants with data available at specific time point were analyzed.|||Hour*Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2612346|NCT02034123|Secondary|Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) Following Single and Repeat Dose Administration of GSK2879552|Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-t) following single (Day 1) and repeat dose (Day 15) administration of GSK2879552. Pharmacokinetic analysis of GSK2879552 in Part 1 was conducted by non-compartmental methods. The analysis was performed on Pharmacokinetic Population which included all participants in the All Treated Population for whom a pharmacokinetic sample was obtained and analyzed. NA represents data was not available. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and Day 15|Pharmacokinetic Population|||Hour*Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2612347|NCT02034123|Primary|Part 2: Number of Participants Achieving Disease Control Rate at Week 16|Clinical response was planned to be assessed by the investigator using computer tomography or magnetic resonance imaging scans. Clinical response was defined as disease control rate based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at Week 16. Disease control rate was defined as number of participants achieving complete response (CR), partial response (PR) and stable disease (SD) per RECIST version 1.1. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.|Week 16|All Treated Population. Data were not collected in Part 2 as no participant was enrolled in Part 2.||||||
2612348|NCT02034123|Primary|Part 1: Number of Participants With Abnormal Findings Undergoing Physical Examinations|The complete physical examination included assessments of the head, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes and extremities. A brief physical examination included assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). All abnormal physical examination findings were reported as AEs within the AE specific case report form (CRF) page. Hence, data was not captured separately for this outcome as number of participants with abnormal findings with respect to physical examinations. NA indicates data was not available as all abnormal physical examination findings were reported as AEs.|Median of 7.286 weeks of drug exposure|All Treated Population|||Participants|||Number
2612349|NCT02034123|Primary|Part 1: Number of Participants With Abnormal Findings for Electrocardiogram (ECG) Parameters|"Single measurements of 12-lead ECGs were obtained in a semi-recumbent or supine position after at least a 5 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. The number of participants with abnormal - not clinically significant and abnormal - clinically significant worst-case on-therapy value have been presented."|Median of 7.286 weeks of drug exposure|All Treated Population. Only those participants with data available at specific time point were analyzed.|||Participants|||Number
2612567|NCT02032212|Primary|Nicotine Plasma Concentration|Maximum plasma nicotine concentration (Cmax)|1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours||||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2612350|NCT02034123|Primary|Part 1:Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug|Vital sign measurements includes systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature, respiration rate and heart rate. Vital signs were measured after resting for at least 5 minutes in a semi-supine position. The number of participants with critical changes in values of vital signs in response to drug have been presented.|Median of 7.286 weeks of drug exposure|All Treated Population|||Participants|||Number
2612351|NCT02034123|Primary|Part 1: Number of Participants With Change in Hematology Toxicity Grade From Baseline|Blood samples were collected for the analysis of hematology parameters including hemoglobin, lymphocytes, total neutrophils, platelet count and white blood cell (WBC) count. Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The number of participants with any grade increase in hematology parameters have been presented. The hematology parameters for which any grade increase worst-case on-therapy value was reported have been only summarized.|Baseline and median of 7.286 weeks of drug exposure|All Treated Population. Only those participants with data available at specific time point were analyzed.|||Participants|||Number
2612352|NCT02034123|Primary|Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline|Blood samples were collected for evaluation of clinical chemistry parameters including potassium, aspartate aminotransferase (AST), total bilirubin, creatinine, alanine aminotransferase (ALT), uric acid, glucose, gamma glutamyl transferase (GGT), albumin, sodium, calcium, alkaline phosphatase, and phosphorus, inorganic. Baseline value was defined as the most recent, non-missing value from a central laboratory prior to or on the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The number of participants with any grade increase in clinical chemistry parameters have been presented. The clinical chemistry parameters for which any grade increase worst-case on-therapy value was reported have been only summarized. NA represents data was not available. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and median of 7.286 weeks of drug exposure|All Treated Population|||Participants|||Number
2612353|NCT02034123|Primary|Part 1: Number of Participants Withdrawn Due to Toxicities|Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to toxicities has been presented.|Median of 7.286 weeks of drug exposure|All Treated Population|||Participants|||Number
2612354|NCT02034123|Primary|Part 1: Number of Participants With Dose Reduction or Delays|The number of participants who had any dose reduction or delay have been presented. All dose reductions were due to AEs.|Median of 7.286 weeks of drug exposure|All Treated Population|||Participants|||Number
2612355|NCT02034123|Primary|Part 1: Number of Participants With Dose Limiting Toxicities (DLT)|An event was considered a DLT if it occurs within the first 28 days of treatment, and meets one of the following criteria unless it can be clearly established that the event is unrelated to treatment: recurrent Grade 3 anemia after initial transfusion or Grade 3 anemia lasting > 7 days in participants who are not transfused, Grade 4 neutropenia, Grade 3 neutropenia > 7 days duration, febrile neutropenia as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, Grade 3 thrombocytopenia requiring dose reduction, Grade 4 thrombocytopenia lasting > 3 days or of any duration if associated with clinically significant bleeding, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 2 toxicity (at any time during treatment) and treatment delay of 14 days or greater due to unresolved drug-related toxicity.|Median of 7.286 weeks of drug exposure|All Treated Population|||Participants|||Number
2612356|NCT02034123|Primary|Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. The analysis was performed on All Treated Population which included all participants who received at least one dose of study treatment.|Median of 7.286 weeks of drug exposure|All Treated Population|||Participants|||Number
2612357|NCT02034058|Secondary|Rate of Stroke in the Territory of the Stented Artery Among Participants|Stroke in the vascular territory of the stented artery|within 72 hours post procedure||||Participants|||Count of Participants
2612358|NCT02034058|Secondary|Rate of Stroke Recovery Among Participants|Stroke recovery at 90 days post procedure is defined by return to baseline mRS at Day 90.|at 90 days post procedure||||Participants|||Count of Participants
2612359|NCT02034058|Secondary|Rate of Neurological Death Among Participants|A diagnosis of death by neurological criteria|within 72 hours post procedure||||Participants|||Count of Participants
2612360|NCT02034058|Secondary|Rate of Ischemic Stroke Among Participants|Ischemic stroke was defined as a neurological deficit that is thought to have an ischemic etiology and is detectable on examination at least 24 hours after onset of symptoms.|within 72 hours post procedure||||Participants|||Count of Participants
2612361|NCT02034058|Primary|Rate of Stroke or Death Among Participants|The primary endpoint in this study is the rate of stroke (ischemic or hemorrhagic) or death within 72 hours of the procedure. Ischemic stroke was defined as a neurological deficit that is thought to have an ischemic cause and is detectable on examination at least 24 hours after onset of symptoms. Hemorrhagic stroke was defined as a symptomatic intracerebral, subarachnoid, or primary intraventricular hemorrhage. The type of stroke was confirmed by imaging.|within 72 hours of the procedure||||Participants|||Count of Participants
2612362|NCT02034019|Primary|Absence of Pain in Study Eye||Day 8||||Participants|||Count of Participants
2612363|NCT02034019|Primary|Absence of Cells in Anterior Chamber of the Study Eye||Day 14||||Participants|||Count of Participants
2612443|NCT02033850|Secondary|Transition to Dementia|"Data collected during the 1-year follow-up visit were used to evaluate the occurrence of a transition from MCI to dementia according to DSM-V criteria.~Chi square test for a 2x2 contingency table was used to compare patients who became demented at 1-year follow-up visit with those who did not, in the two treatment groups."|12 months||||Participants|||Count of Participants
2612364|NCT02034006|Primary|Number of Patients in Different Categories of Changes From Baseline in BCVA|"Changes from baseline in BCVA are described for the ETDRS parameter considering the following categories at each assessment: no change if the change was equal to 0 letter, worsening if change < 0 letter , improvement if change > 0 letter. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of change from baseline in BCVA (improved/worsened/stable) which was reported as Improved versus no change and worsened versus no change. For retreated patients, this variable was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis."|Baseline, Month 1, Month 2, Month 3, Month 6, Month 12|Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and evaluable BCVA at baseline and that time point.|||Patients|||Number
2612365|NCT02034006|Primary|Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 10 Letters|Improvement in BCVA < 10 letters (Yes/No) was assessed at month1, month 2, month 3, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of improvement in BCVA < 10 letters (Yes/No) which was reported as Gain >= 10 letters versus Gain < 10 letters. For retreated patients, Gain >= 10 letters and Gain < 10 letters were considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis.|Baseline, Month 1, Month 2, Month 3, Month 6, Month 12|Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab with improvement in BCVA < 10 letters from baseline to that time point.|||Patients|||Number
2612366|NCT02034006|Primary|Number of Patients Treated and Re-treated Based on Improvement in Best Corrective Visual Acuity (BCVA) < 5 Letters|Improvement in BCVA < 5 letters (Yes/No) was assessed at month1, month 2, month 3, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of improvement in BCVA < 5 letters (Yes/No) which was reported as Gain >= 5 letters versus Gain < 5 letters. For retreated patients, Gain >= 5 letters and Gain < 5 letters were considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis.|Baseline, Month 1, Month 2, Month 3, Month 6, Month 12|Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab with improvement in BCVA < 5 letters from baseline at that time point.|||Patients|||Number
2612367|NCT02034006|Primary|Number of Patients Treated and Re-treated Based on Presence/Absence of Clinically Significant Abnormalities|Presence of clinically significant abnormalities was assessed at baseline, month 1, month 2, month 3, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of clinically significant abnormalities (Yes/No). For retreated patients, the presence/absence of clinically significant abnormalities was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis.|Baseline, Month 1, Month 2, Month 3, Month 6, Month 12|Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent ocular examination during that time point.|||Patients|||Number
2612368|NCT02034006|Primary|Number of Patients Treated and Re-treated Based on Presence/Absence of Sub-retinal Fluid|"Presence of sub-retinal fluid from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. The regression model for sub-retinal fluid was not valid because Yes was reported in almost all subjects causing a quasi-complete separation of data points. *NE = Not evaluable"|Screening, Month 2, Month 6, Month 12|Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent OCT at that time point.|||Patients|||Number
2612369|NCT02034006|Primary|Change in Central Subfield Volume (CSV)|Central subfield volume (CSV) from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of change in CSV versus previous visit. For retreated patients, the change in CSV was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis.|Screening, Month 2, Month 6, Month 12|Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent OCT at that time point and the previous visit.|||mm^3||Standard Deviation|Mean
2612370|NCT02034006|Primary|Change in Central Subfield Thickness (CSFT)|Central subfield thickness (CSFT) from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of change in CSFT versus previous visit. For retreated patients, the change in CSFT was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis.|Screening, Month 2, Month 6, Month 12|Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent OCT at that time point and previous visit.|||micromilimeter(um)||Standard Deviation|Mean
2612451|NCT02033499|Secondary|Number of Participants on Specified Diabetes Medications at Baseline and Follow-up|Number of participants taking each of the following medications at baseline and follow-up: metformin, sulfonylurea, glinides, Glucagon-like peptide-1 (GLP-1), Thiazolidinediones (TZD), and dipeptidyl peptidase IV (DPP-IV).|Baseline and 52 weeks|Medication regimens vary among patients.|||Participants|||Count of Participants
2612371|NCT02034006|Primary|Number of Patients Treated and Re-treated Based on Presence/Absence of Intra-retinal Fluid|Presence of Intra-retinal fluid from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of Intra-retinal fluid (Yes/No). For retreated patients, the presence/absence of Intra-retinal fluid was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. *NE = Not evaluable|Screening, Month 2, Month 6, Month 12|Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent OCT at that time point.|||Patients|||Number
2612372|NCT02034006|Primary|Number of Patients Treated and Re-treated Based on Presence/Absence of Cysts|Presence of cysts from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of cysts (Yes/No). For retreated patients, the presence/absence of cysts was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. *NE = Not evaluable|Screening, Month 2, Month 6, Month 12|Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent OCT at that time point.|||Patients|||Number
2612373|NCT02034006|Primary|Number of Patients Treated and Re-treated Based on Presence/Absence of Macular Edema|Presence of macular edema from optical coherence tomography (OCT) was assessed at screening (14 to 3 days before baseline visit), month 2, month 6 and month 12. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of macular edema (Yes/No). For retreated patients, the presence/absence of macular edema was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. *NE = Not evaluable|Screening, Month 2, Month 6, Month 12|Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent OCT at that time point.|||Patients|||Number
2612374|NCT02034006|Secondary|Change in Patient Quality of Life From Baseline to Month 2 and Month 12|Patient quality of life was assessed by Impact of Vision Impairment (IVI) questionnaire. IVI is a 32-item instrument, either self- or interviewer-administered, developed to measure the impact of vision impairment on daily activities in five domains. The 32 items were divided into 5 domains as follows: Leisure and work (items 1 to 5), Social and consumer interaction (items 6 to 10 and items 23-24), Household and personal care (items 11 to 14 and items 20-21), Mobility (items 15 to 19 and item 22), Emotional reaction to vision loss (items 25 to 32). Responses to the IVI items were rated on a five-category Likert scale: not at all, 0; hardly at all, 1; a little, 2; a fair amount, 3; a lot, 4; and can't do because of eyesight, 5. Total score was an arithmetic average of the items rated between 0 (the best score) and 5 (the worst score). A negative change indicates improvement. Data was computed on items with non missing response|Baseline, Month 2, Month 12|Full Analysis Set (FAS): all subjects who received at least one dose of ranibizumab with data at both timepoints.|||units on a scale||Standard Deviation|Mean
2612375|NCT02034006|Secondary|Number of Patients Having Ocular and/or Systemic Adverse Event (AE)|Number of patients with any systemic AE, with serious systemic AE, with an ocular AE, with an ocular serious AE are reported|Baseline to Month 12|Safety Population: all subjects who received at least one dose of ranibizumab and had at least one post-baseline safety assessment.|||Patients|||Number
2612376|NCT02034006|Secondary|Time to Re-treatment|Time to re-treatment, defined as time in months from the data of first dose of ranibizumab to the date of re-treatment, was evaluated.|Baseline to Month 12|Full Analysis Set (FAS): all subjects who received at least one dose of ranibizumab|||Months||Standard Deviation|Mean
2612377|NCT02034006|Secondary|Mean Number of Ranibizumab Injection|Mean number of ranibizumab injection is reported as number of injections per patient.|Baseline to Month 12|Full Analysis Set (FAS): all subjects who received at least one dose of ranibizumab|||injections||Standard Deviation|Mean
2612378|NCT02034006|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 6 and Month 12 on Study Eye|Change from baseline in BCVA (Best Corrected Visual Acuity) was Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score. Patients with a BCVA ETDRS letter score of 78 to 24 in the study eye were included; A higher score represents better functioning of the study eye. A positive change from baseline shows improvement.|Baseline, Month 6, Month 12|Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab. The study eyes of the patients belonging to the FAS were analyzed.|||letters|study eyes|Standard Deviation|Mean
2612379|NCT02034006|Primary|Number of Patients Treated and Re-treated Based on Presence/Absence of Active Leakage|Presence of active leakage on fluorescein angiography (FAG) was assessed at screening (14 to 3 days before baseline visit), month 2 and month 6. A univariate logistic regression model was applied expressing the presence/absence of the first retreatment in function of presence of active leakage (Yes/No). For retreated patients, the presence/absence of active leakage was considered at the closest time-point to the first re-treatment: the last scheduled assessment immediately before the first re-treatment was considered. For treated patients, the last scheduled assessment available was considered. In case of missing value on the scheduled assessment, the value was considered as missing for this analysis. *NE = Not evaluable|Screening, Month 2, Month 6|Full Analysis Set (FAS): all patients who received at least one dose of ranibizumab and underwent fluorescein angiography at that time point.|||Patients|||Number
2612452|NCT02033499|Secondary|Baseline Health Care Utilization and at 52 Weeks|Primary care visits, hospitalization, urgent care, and emergency room and emergency medical service (EMS) visits recorded at baseline and 52 weeks.|Baseline and 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able provide this information, yet did provide blood samples for A1c testing and vice versa.|||number of events||Standard Deviation|Mean
2612380|NCT02033993|Secondary|Health Related Quality of Life Evaluated Using EORTC-C15-Pal|"Quality of life will be assessed using the EORTC-C15-PAL questionnaire plus additional study specific questions.~Changes in quality of life scores while on treatment (compared to baseline scores) will be examined using descriptive analyses and inferential statistics. The primary test to compare treatment arms will be the NCIC CTG Quality of Life Committee suggested response analyses. A change score of 10 points from baseline was defined as clinically relevant. Patients were considered improved if reported a score 10-points or better than baseline at any time point in QoL assessment. Conversely, patients were considered worsened if reported a score minus 10-points or worse than baseline at any time point in QOL assessment without the above-defined improvement being observed. Patients whose scores were between 10-point changes from baseline at every QoL assessment were considered as stable."|42 months|Patients with baseline and at least 1 after treatment evaluation.|||Participants|||Count of Participants
2612381|NCT02033993|Secondary|Time to Response|Time from the date of randomkization to the date of objective response according to RECIST Response Criteria was first achieved.|42 months|ITT population|||Months||95% Confidence Interval|Median
2612382|NCT02033993|Secondary|Clinical Benefit Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started. Clinical Benefit Rate = OR + SD > 12 weeks.|42 months|ITT population|||percentage of participants||90% Confidence Interval|Number
2612383|NCT02033993|Secondary|Overall Survival|Time from randomization to the date of death due to any causes, or censored at last contact date.|42 months|ITT piopulation|||Months||90% Confidence Interval|Median
2612384|NCT02033993|Primary|Progression-Free Survival|PFS is defined as the time from randomization to the first observation of disease progression or death due to any cause.|42 months|ITT population.|||Months||90% Confidence Interval|Median
2612385|NCT02033889|Secondary|Percent Change From Baseline in Bone Biomarker PTH at Week 104 (Excluding Bone Rescue Approach)|PTH is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 104|All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 104.|||Percent change||Standard Deviation|Mean
2612386|NCT02033889|Secondary|Percent Change From Baseline in Bone Biomarker P1NP at Week 104 (Excluding Bone Rescue Approach)|P1NP is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 104|All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 104.|||Percent change||Standard Deviation|Mean
2612387|NCT02033889|Secondary|Percent Change From Baseline in Bone Biomarker CTX at Week 104 (Excluding Bone Rescue Approach)|CTX is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 104|All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 104.|||Percent change||Standard Deviation|Mean
2612388|NCT02033889|Secondary|Percent Change From BMD at Week 104 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)|BMD at the distal forearm was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 104|All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.|||Percent change||95% Confidence Interval|Least Squares Mean
2612389|NCT02033889|Secondary|Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)|BMD at the total hip was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 104|All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.|||Percent change||95% Confidence Interval|Least Squares Mean
2612390|NCT02033889|Secondary|Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)|BMD at the femoral neck was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 104|All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.|||Percent change||95% Confidence Interval|Least Squares Mean
2612391|NCT02033889|Secondary|Percent Change From Baseline in BMD at Week 104 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)|BMD at the femoral neck was assessed by DXA at Week 0 and Week 104. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 104|All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.|||Percent change||95% Confidence Interval|Least Squares Mean
2612392|NCT02033889|Secondary|Percent Change From Baseline in Bone Biomarker PTH at Week 52 (Excluding Bone Rescue Approach)|PTH is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 52|All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 52.|||Percent Change||Standard Deviation|Mean
2612393|NCT02033889|Secondary|Percent Change From Baseline in Bone Biomarker P1NP at Week 52 (Excluding Bone Rescue Approach)|P1NP is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 52|All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 52.|||Percent Change||Standard Deviation|Mean
2612394|NCT02033889|Secondary|Percent Change From Baseline in Bone Biomarker CTX at Week 52 (Excluding Bone Rescue Approach)|CTX is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 52|All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 52.|||Percent change||Standard Deviation|Mean
2612395|NCT02033889|Secondary|Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)|BMD at the distal forearm was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 52|All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.|||Percent change||95% Confidence Interval|Least Squares Mean
2612396|NCT02033889|Secondary|Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)|BMD at the total hip was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 52|All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.|||Percent change||95% Confidence Interval|Least Squares Mean
2612397|NCT02033889|Secondary|Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)|BMD at the femoral neck was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 52|All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.|||Percent change||95% Confidence Interval|Least Squares Mean
2612398|NCT02033889|Secondary|Percent Change From Baseline in BMD at Week 52 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)|BMD at the femoral neck was assessed by DXA at Week 0 and Week 52. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 52|All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.|||Percent change||95% Confidence Interval|Least Squares Mean
2612399|NCT02033889|Secondary|Percent Change From Baseline in Bone Biomarker Parathyroid Hormone (PTH) at Week 26 (Excluding Bone Rescue Approach)|PTH is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 26|All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 26.|||Percent change||Standard Deviation|Mean
2612400|NCT02033889|Secondary|Percent Change From Baseline in Bone Biomarker Procollagen Type I N-terminal Propeptide (P1NP) at Week 26 (Excluding Bone Rescue Approach)|P1NP is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 26|All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 26.|||Percent change||Standard Deviation|Mean
2612401|NCT02033889|Secondary|Percent Change From Baseline in Bone Biomarker Carboxy-Terminal Cross-Linking Telopeptides of Type I Collagen (CTX) at Week 26 (Excluding Bone Rescue Approach)|CTX is a biochemical marker of bone resorption. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 26|All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 26.|||Percent change||Standard Deviation|Mean
2612784|NCT02029521|Primary|BMI Percentile|Body Mass Index percentile adjusted for sex and age. Not available for participants under 2 years of age.|6 months|All old enough to have BMI percentile calculated. BMI percentile not available for children under 2 years of age|||Percentile adjusted for age and sex||Standard Deviation|Mean
2612402|NCT02033889|Secondary|Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Distal Forearm Using Raw Data (Excluding Bone Rescue Approach)|BMD at the distal forearm was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 26|All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.|||Percent change||95% Confidence Interval|Least Squares Mean
2612403|NCT02033889|Secondary|Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Total Hip Using Raw Data (Excluding Bone Rescue Approach)|BMD at the total hip was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 26|All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.|||Percent change||95% Confidence Interval|Least Squares Mean
2612404|NCT02033889|Secondary|Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Femoral Neck Using Raw Data (Excluding Bone Rescue Approach)|BMD at the femoral neck was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 26|All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.|||Percent change||95% Confidence Interval|Least Squares Mean
2612405|NCT02033889|Secondary|Percent Change From Baseline in BMD at Week 26 as Measured by DXA at the Lumbar Spine (L1-L4) Using Raw Data (Excluding Bone Rescue Approach)|BMD at the femoral neck was assessed by DXA at Week 0 and Week 26. Participants who exhibited a significant reduction in BMD according to the protocol defined criteria completed an unscheduled DXA scan and, if required, received bone-active therapy. This table excludes measurements obtained after initiation of bone rescue medications.|Baseline and Week 26|All randomized participants who have received at least one dose of investigational product and have a measurement at baseline and at least one post-baseline measurement.|||Percentage change||95% Confidence Interval|Least Squares Mean
2612406|NCT02033889|Secondary|Ertugliflozin Plasma Concentrations (ng/mL): Summary Statistics Over Time (Excluding Rescue Approach)|Pharmacokinetic samples were collected at approximately 24 hours following the prior day's dose and before administration of the current day's dose. The lower limit of quantitation (LLOQ) was 0.500 mg/mL. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Pre-dose and/or 60 minutes post-dose on Weeks 6, 12, 18, and 30|All subjects as treated (including those with all concentrations below the lower limit of quantification) were included in the calculation of the summary statistics. Numbers of participants with non-missing concentrations at the respective time points are displayed.|||ng/mL||Standard Deviation|Mean
2612407|NCT02033889|Secondary|Change From Baseline in Sitting Diastolic Blood Pressure at Week 104 (Excluding Rescue Approach)|This change from baseline reflects the Week 104 sitting DBP minus the Week 0 sitting DBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 104|All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 104.|||mmHg||Standard Deviation|Mean
2612408|NCT02033889|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 104 (Excluding Rescue Approach)|This change from baseline reflects the Week 104 sitting SBP minus the Week 0 sitting SBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 104|All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 104.|||mmHg||Standard Deviation|Mean
2612409|NCT02033889|Secondary|Change From Baseline in Body Weight at Week 104 (Excluding Rescue Approach)|The change in body weight from baseline reflects the Week 104 body weight minus the Week 0 body weight. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 104|All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 104.|||Kilograms||Standard Deviation|Mean
2612410|NCT02033889|Secondary|Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 104|Per protocol participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment.|Up to Week 104|All participants who received at least one dose of investigational product.|||Percentage of participants||95% Confidence Interval|Number
2612411|NCT02033889|Secondary|Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 104 (Excluding Rescue Approach)|A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Week 104|"All randomized participants who received at least one dose of investigational product. Any participant without post-baseline data at Week 104 was assumed to be not at goal, where goal was A1C <6.5% for the calculation of the percentages."|||Percentage of Participants|||Number
2612412|NCT02033889|Secondary|Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 104 (Excluding Rescue Approach)|A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Week 104|"All randomized participants who received at least one dose of investigational product. Any participant without post-baseline data at Week 104 was assumed to be not at goal, where goal was A1C <7%, for the calculation of the percentages."|||Percentage of Participants|||Number
2612413|NCT02033889|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 104 (Excluding Rescue Approach)|Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 104 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 104 minus FPG at Week 0). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 104|All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 104.|||mg/dL||Standard Deviation|Mean
2612414|NCT02033889|Secondary|Change From Baseline in A1C at Week 104 (Excluding Rescue Approach)|A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 104 A1C minus the Week 0 A1C. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 104|All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 104.|||Percent A1C||Standard Deviation|Mean
2612415|NCT02033889|Secondary|Change From Baseline in Sitting Diastolic Blood Pressure at Week 52 (Excluding Rescue Approach)|This change from baseline reflects the Week 52 sitting DBP minus the Week 0 sitting DBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 52|All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 52.|||mmHg||Standard Deviation|Mean
2612416|NCT02033889|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 52 (Excluding Rescue Approach)|This change from baseline reflects the Week 52 sitting SBP minus the Week 0 sitting SBP. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 52|All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 52.|||mmHg||Standard Deviation|Mean
2612417|NCT02033889|Secondary|Change From Baseline in Body Weight at Week 52 (Excluding Rescue Approach)|The change in body weight from baseline reflects the Week 52 body weight minus the Week 0 body weight. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 52|All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 52.|||Kilograms||Standard Deviation|Mean
2612418|NCT02033889|Secondary|Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 52|Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment.|Up to Week 52|All participants who received at least one dose of investigational product.|||Percentage of Participants||95% Confidence Interval|Number
2612419|NCT02033889|Secondary|Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 52 (Excluding Rescue Approach)|A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Week 52|"All randomized participants who received at least one dose of investigational product. Any participant without post-baseline data at Week 52 was assumed to be not at goal, where goal was A1C <6.5%, for the calculation of the percentages."|||Percentage of Participants|||Number
2612420|NCT02033889|Secondary|Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 52 (Excluding Rescue Approach)|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Week 52|"All randomized participants who received at least one dose of investigational product. Any participant without post-baseline data at Week 52 was assumed to be not at goal, where goal was A1C <7%, for the calculation of the percentages."|||Percentage of Participants|||Number
2612453|NCT02033499|Secondary|Hypoglycemia Frequency|Number of participants with hypoglycemia events for the 52 week intervention period.|Baseline to 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to provide information for this measure, yet did provide blood samples for A1c testing and vice versa.|||Participants|||Count of Participants
2612421|NCT02033889|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 52 (Excluding Rescue Therapy)|Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 52 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 52 minus FPG at Week 0). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 52|All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 52.|||mg/dL||Standard Deviation|Mean
2612422|NCT02033889|Secondary|Change From Baseline in A1C at Week 52 (Excluding Rescue Approach)|A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 52 A1C minus the Week 0 A1C. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 52|All randomized participants who have received at least one dose of investigational product and have measurements of the respective endpoint at both baseline and Week 52.|||Percent A1C||Standard Deviation|Mean
2612423|NCT02033889|Secondary|Time to Glycemic Rescue Therapy at Week 26|Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment.|Week 26|All participants who received at least one dose of investigational product and received glycemic rescue through Week 26.|||Days||Full Range|Median
2612424|NCT02033889|Secondary|Percentage of Participants Receiving Glycemic Rescue Therapy up to Week 26|Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment.|Up to Week 26|All participants who received at least one dose of investigational product.|||Percentage of Participants|||Number
2612425|NCT02033889|Secondary|Percentage of Participants With an A1C of <6.5% (48 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach)|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Week 26|All randomized participants who took at least one dose of study medication and had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26.|||Percentage of Participants|||Number
2612426|NCT02033889|Secondary|Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 (Excluding Rescue Approach)|This change from baseline reflects the Week 26 sitting diastolic blood pressure (DBP) minus the Week 0 sitting DBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 26|All randomized participants who took at least one dose of study medication and had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26.|||mmHg||95% Confidence Interval|Least Squares Mean
2612427|NCT02033889|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 26 (Excluding Rescue Approach)|This change from baseline reflects the Week 26 sitting systolic blood pressure (SBP) minus the Week 0 sitting SBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 26|All randomized participants who took at least one dose of study medication and had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26.|||mmHg||95% Confidence Interval|Least Squares Mean
2612428|NCT02033889|Secondary|Percentage of Participants With an A1C of <7% (53 mmol/Mol) at Week 26 (Logistic Regression Using Multiple Imputation: Excluding Rescue Approach)|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Week 26|All randomized participants who took at least one dose of study medication and had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26.|||Percentage of Participants|||Number
2612429|NCT02033889|Secondary|Change From Baseline in Body Weight at Week 26 (Excluding Rescue Approach)|The change in body weight from baseline reflects the Week 26 body weight minus the Week 0 body weight (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 26|All randomized participants who took at least one dose of study medication and had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26.|||Kilograms||95% Confidence Interval|Least Squares Mean
2612785|NCT02029521|Secondary|C-Reactive Protein (CRP)|CRP was measured to determine if this test fell during the course of treatment.|6 months|All participants.|||milligrams per liter||Standard Deviation|Mean
2612430|NCT02033889|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 26 (Excluding Rescue Approach)|Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at Week 0) which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 26|All randomized participants who took at least one dose of study medication and had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26.|||mg/dL||95% Confidence Interval|Least Squares Mean
2612431|NCT02033889|Primary|Percentage of Participants Discontinuing Study Treatment Due to an AE (Including Rescue Approach)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Per protocol, participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or basal insulin according to Investigator judgment.|Up to Week 104|All participants who received at least one dose of investigational product.|||Percentage of Participants|||Number
2612432|NCT02033889|Primary|Percentage of Participants Experiencing An Adverse Event (AE) (Including Rescue Approach)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Per protocol, participants who met pre-specified glycemic criteria were rescued with open-label glimepiride or basal insulin according to Investigator judgment.|Up to Week 106|All participants who received at least one dose of investigational product.|||Percentage of Participants|||Number
2612433|NCT02033889|Primary|Change From Baseline in A1C at Week 26 (Excluding Rescue Approach)|A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride or basal insulin injected subcutaneously, and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy.|Baseline and Week 26|All randomized participants who took at least one dose of study medication and had at least one assessment of the respective endpoint at baseline or post-baseline up to Week 26.|||Percent A1C||95% Confidence Interval|Least Squares Mean
2612434|NCT02033876|Secondary|Change in FGF-19|Change in fasting fibroblast growth factor (FGF)-19 expression.|baseline, post-treatment approximately 14 - 17 days||||mg/dL||Inter-Quartile Range|Median
2612435|NCT02033876|Secondary|Change in Body Mass Index|Change in subjects BMI, in kilograms per meter squared.|baseline, post-treatment approximately 14 - 17 days||||kg/m^2||Inter-Quartile Range|Median
2612436|NCT02033876|Secondary|Change in Weight|Change in subject's weight, in kilograms|baseline, post-treatment approximately 14 - 17 days||||kilograms||Inter-Quartile Range|Median
2612437|NCT02033876|Secondary|Gastric Emptying of Solids (T1/2)|The time for half of the ingested solids to leave the stomach. Following a meal consisting of two eggs labeled with technetium Tc 99m sulfur colloid (1 mCi) served with 50g of Canadian bacon and one slice of bread gastric emptying of solids was assessed with scintigraphy imaging.|post-treatment, approximately 14-17 days||||minutes||Inter-Quartile Range|Median
2612438|NCT02033876|Secondary|Gastric Emptying of Liquids (T1/2)|The time for half of the ingested liquids to leave the stomach. Following a meal with milk labeled with indium In111 diethylenetriaminepentaacetate (0.1 mCi), gastric emptying of liquids was assessed with scintigraphy imaging.|post-treatment, approximately 14-17 days||||minutes||Inter-Quartile Range|Median
2612439|NCT02033876|Secondary|Change in Insulin Sensitivity|Insulin sensitivity will be calculated by the oral minimal model.|baseline, post-treatment approximately 14 - 17 days||||mg/dL x minutes||Inter-Quartile Range|Median
2612440|NCT02033876|Secondary|Change in Fasting Glucose|Serum glucose measurements taken after 10 hours of fasting.|baseline, post-treatment approximately 14 - 17 days||||mg/dL||Inter-Quartile Range|Median
2612441|NCT02033876|Primary|Change in Area Above Basal (AAB) for Glucose|Mixed meal glucose results are used to calculate the area above basal (AAB) for glucose. The glycemic index of a food is defined as the incremental area under the two-hour blood glucose response curve (AUC) following an overnight fast and ingestion of a food with a certain quantity of available carbohydrate (usually 50 g).|baseline, post-treatment approximately 14 - 17 days||||mg/dL x min||Inter-Quartile Range|Median
2612442|NCT02033850|Secondary|Cognitive Plasticity|Improvement in long-term brain activity was measured by means of regional homogeneity (ReHo) of resting state functional MRI (rsfMRI) data. Statistical analysis of rsfMRI data was carried out by feeding Z-transformed ReHo data into voxel-wise inter-subject statistics using permutation-based nonparametric inference within the general linear model framework. P-values were calculated employing permutation-based statistics and corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement, and a p-value <0.05 was considered statistically significant. Z-transformed ReHo differences (12 months-baseline) were computed separately for treated and non-treated patients, and a voxel-wise between-group comparison was used to evaluate the treatment effect . A positive mean of the Z-transformed ReHo differences represents an increase in activation over time (better outcome), and a negative mean represents a decrease in activation over time (worse outcome).|Baseline, 12 months|RsfMRI data were available in in 22 patients (12 treated and 10 non-treated) after the exclusion of patients for technical reasons or head movement greater than 2 mm, and patients with incidental non-lacunar infarcts in the cerebral cortex, cerebellum, or brainstem to avoid a possible confounding effect on rsfMRI analysis.|||standard Z-values||Inter-Quartile Range|Median
2612786|NCT02029521|Secondary|FEV1|Forced expiratory volume at one second, percent predicted.|6 months|PFT's not done on children under age of 5.|||Percent predicted||Standard Deviation|Mean
2612444|NCT02033850|Secondary|Cognitive Performance (Clinically Significance Approach)|"Clinically significance approach. The availability of national norms for the cognitive variables allowed us to classify each patient's performance as 'normal', 'borderline' or 'abnormal' at each visit. Variations in performance categories over time (baseline vs. 6 month; 6 vs. 12 month; baseline vs. 12 month) were evaluated for each patient and dichotomized as: 'stable or better evaluation' or 'worst evaluation'. Variations in performance categories were analyzed using chi square tests.~Test battery:~global cognitive functioning: Montreal Cognitive Assessment, MoCA; Mini Mental Status Examination, MMSE~memory: Rey Auditory-Verbal Learning (RAVL) immediate and recall, Short story, Rey-Osterrieth Complex Figure (ROCF) recall~attention/executive function: Trail Making Test part A and B (TMT-A and B), Visual search, Symbol Digit Modalities Test (SDMT), Stroop Test~language: phonemic and semantic verbal fluency~constructional praxis: ROCF copy"|Baseline, 6 months and 12 months|Not all the participants completed the entire neuropsychological evaluation during the follow-up visits due to refuse or failure to learn or remember the instructions, or to perform the task until the end|||Participants|||Count of Participants
2612445|NCT02033850|Secondary|Cognitive Performance Verbal Fluency (Changes in Scores Approach)|"Delta (Δ) scores were calculated by computing the difference between the scores obtained in 2 evaluations (baseline vs. 6 months; 6 vs. 12 months; baseline vs. 12 months) for each patient. A positive Δ score indicates an improvement, while a negative Δ score indicates a worsening. Delta scores were analyzed using independent sample t tests with treatment as the only independent variable.~Cognitive tests based on the total number of words produced: phonemic (minimum and maximum values not applicable) and semantic verbal fluency (minimum and maximum values not applicable). Higher scores mean better outcome for both tests."|Baseline, 6 months and 12 months|Not all the participants completed the entire neuropsychological evaluation during the follow-up visits due to refuse or failure to learn or remember the instructions, or to perform the task until the end|||words||Standard Deviation|Mean
2612446|NCT02033850|Secondary|Cognitive Performance TMT-A, TMT-B, Stroop (Changes in Scores Approach)|"Delta (Δ) scores were calculated by computing the difference between the scores obtained in 2 evaluations (baseline vs. 6 months; 6 vs. 12 months; baseline vs. 12 months) for each patient. A positive Δ score indicates an improvement, while a negative Δ score indicates a worsening. Delta scores were analyzed using independent sample t tests with treatment as the only independent variable.~Cognitive tests based on execution time in seconds: Trail Making Test TMT part A (minimum and maximum values 0-300), TMT part B (minimum and maximum values 0-300), and Stroop Test (minimum and maximum values 0-300). Higher scores mean worse outcome."|Baseline, 6 months and 12 months|Not all the participants completed the entire neuropsychological evaluation during the follow-up visits due to refuse or failure to learn or remember the instructions, or to perform the task until the end|||seconds||Standard Deviation|Mean
2612447|NCT02033850|Secondary|Cognitive Performance (Changes in Scores Approach)|"Delta (Δ) scores were calculated by computing the difference between the scores obtained in 2 evaluations (baseline vs. 6 months; 6 vs. 12 months; baseline vs. 12 months) for each patient. A positive Δ score indicates an improvement, while a negative Δ score indicates a worsening. Delta scores were analyzed using independent sample t tests with treatment as the only independent variable.~Test battery: Montreal Cognitive Assessment MoCA (minimum and maximum values 0-30); Mini Mental Status Examination MMSE (minimum and maximum values 0-30), Rey Auditory-Verbal Learning RAVL immediate (minimum and maximum values 0-75) and recall (minimum and maximum values 0-15), Short story (minimum and maximum values 0-28), Rey-Osterrieth Complex Figure ROCF copy and recall (minimum and maximum values 0-36), Visual search (minimum and maximum values 0-50), Symbol Digit Modalities Test SDMT (minimum and maximum values 0-110). Higher scores mean better outcome for all tests."|Baseline, 6 months and 12 months|Not all the participants completed the entire neuropsychological evaluation during the follow-up visits due to refuse or failure to learn or remember the instructions, or to perform the task until the end|||units on a scale||Standard Deviation|Mean
2612448|NCT02033850|Primary|Quality of Life (Clinically Significance Approach)|Clinically significance approach. The availability of t scores for the Short Form Health Survey (SF-36) Physical and Mental Component Summary scores (MCS, PCS) allowed us to classify each patient evaluation as 'normal well-being' (t score >40) or 'reduced well-being' (t score ≤40) at each visit (higher scores mean a better outcome). Variations in performance categories over time (baseline vs. 6 month; 6 vs. 12 month; baseline vs. 12 month) were evaluated for each patient and dichotomized as: 'stable or better evaluation' or 'worst evaluation'. Variations in performance categories were analyzed using chi square tests.|Baseline, 6 months and 12 months||||Participants|||Count of Participants
2612449|NCT02033850|Primary|Quality of Life (Changes in Scores Approach)|"Changes in scores (Δ) approach. Delta scores (Δs) were calculated by computing the difference between the scores obtained in 2 evaluations (baseline vs. 6 months; 6 vs. 12 months; baseline vs. 12 months) for each patient. All Δs were calculated in order that a positive score indicates an improvement, while a negative score indicates a worsening. Δs were analyzed using independent sample t tests with treatment as the only independent variable.~Scales:~Short Form Health Survey summary scores: Physical and Mental Component Summary (PCS, MCS) (minimum and maximum values 0-100: lower scores mean worse outcome).~EuroQol (EQ): summary index (min-max values 0-1) and visual analogue scale (minimum and maximum values 0-100: higher scores mean better outcome).~Attention Questionnaire (AQ) total score (minimum and maximum values 0-36: higher scores mean worse outcome).~Geriatric Depression Scale (GDS) total score (minimum and maximum values 0-15: higher scores mean worse outcome)."|Baseline, 6 months and 12 months||||units on a scale||Standard Deviation|Mean
2612450|NCT02033850|Primary|Functionality in Activities of Daily Living (Changes in Scores Approach)|"Changes in scores (Δ) approach. Delta scores (Δs) were calculated by computing the difference between the scores obtained in 2 evaluations (baseline vs. 6 months; 6 vs. 12 months; baseline vs. 12 months) for each patient. All Δs were calculated in order that a positive score indicates an improvement, while a negative score indicates a worsening. Δs were analyzed using independent sample t tests with treatment as the only independent variable.~Scales:~Activities of Daily Living (ADL): preserved items summed into a global score (minimum and maximum values 0-6: higher scores mean a better outcome).~Instrumental Activities of Daily Living (IADL): impaired items summed into a global score (minimum and maximum values 0-8: higher scores mean a worse outcome).~Disability Assessment in Dementia (DAD): 40 dichotomous items summed into a total score and converted into a percentage (minimum and maximum values 0-100: higher scores mean a worse outcome)."|Baseline, 6 months and 12 months||||units on a scale||Standard Deviation|Mean
2612454|NCT02033499|Secondary|Change in Patient-Provider Communication From Baseline to 52 Weeks|Change from baseline patient perception of communication with their provider at 52 weeks using the Communication Assessment Tool (CAT). Scale scores range from 1 to 5, with 5 being the best communication.|Baseline to 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete this scale, yet did provide blood samples for A1c testing and vice versa.|||units on a scale||Standard Deviation|Mean
2612455|NCT02033499|Secondary|Change Diabetes Empowerment Scale - Short Form (DES-SF) From Baseline to 52 Weeks|Changes in diabetes-specific self-efficacy using the Diabetes Empowerment Scale - Short Form from baseline at 52 weeks. The scale ranges from 1 to 5, with 5 indicating most empowered.|Baseline to 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete this scale, yet did provide blood samples for A1c testing.|||units on a scale||Standard Deviation|Mean
2612456|NCT02033499|Secondary|Change in Diabetes Treatment Satisfaction Questionnaire Subscale Scores From Baseline to 52 Weeks|Change from baseline patient satisfaction with treatment at 52 weeks using the Diabetes Treatment Satisfaction Questionnaire subscales, overall satisfaction and satisfaction with blood glucose control. For overall satisfaction, the range is 0-36, with 36 (high score) being the most satisfied. For satisfaction with blood glucose control, the subscale range is 0 to 12, with 0 (low score) indicating the most satisfaction.|Baseline to 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete this scale, yet did provide blood samples for A1c testing.|||units on a scale||Standard Deviation|Mean
2612457|NCT02033499|Secondary|Change in Summary of Diabetes Self Care Activities (SDCA) Subscales From Baseline to 52 Weeks|Change in the SDCA subscales (general diet, specific diet, exercise, blood sugar testing, and foot care), a multidimensional measure of diabetes self-management activities, from baseline at 52 weeks will be assessed. For each subscale, the score is the mean number of days specified subscale activities occurred. Each subscale ranges from 0 to 7, with 7 the best score possible.|Baseline to 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete this scale, yet did provide blood samples for A1c testing and vice versa.|||units on a scale||Standard Deviation|Mean
2612458|NCT02033499|Secondary|Change in Diabetes Symptom Checklist- Revised (DSC-R) Overall Score From Baseline to 52 Weeks|Change in diabetes-related symptom frequency and perceived severity from baseline at 52 weeks using the Diabetes Symptom Checklist-Revised. Overall score ranges from 0 to 170, with 170 indicating the worse symptom severity.|Baseline to 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete this scale, yet did provide blood samples for A1c testing and vice versa.|||units on a scale||Standard Deviation|Mean
2612459|NCT02033499|Secondary|Change in Problem Areas in Diabetes Scores From Baseline to 52 Weeks|The change from baseline Problem Areas in Diabetes (PAID) scores will be assessed at 52 weeks. The PAID is a widely used tool to assess psychological and social stress associated with diabetes. The PAID scores range from 0 to 100, with 100 indicating the most distress.|Baseline to 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete this scale, yet did provide blood samples for A1c testing and vice versa.|||units on a scale||Standard Deviation|Mean
2612460|NCT02033499|Primary|Mean Difference in Health-related Quality of Life Scores From Baseline to 52 Weeks|Change in Short Form-36 (SF-36) subscale scores (Physical and Mental subscales) from baseline to 52 weeks. The SF-36 is a widely used measure of health-related quality of life. Each subscale score ranges from 0 - 100, with 100 being the best quality of life score.|Baseline to 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to complete the SF-36, yet did provide blood samples for A1c testing.|||Units on a scale||Standard Deviation|Mean
2612461|NCT02033499|Primary|Absolute Change in % Hemoglobin A1c From Baseline at 52 Weeks|Absolute Change in Glycemic Control (% Hemoglobin A1c) from baseline at 52 weeks|Baseline to 52 weeks|Differences in overall numbers by arm from the completed flow totals are due to the fact that not all participants were able to provide blood samples yet were able to complete all or part of the patient interview.|||Percent Hemoglobin A1c||Standard Deviation|Mean
2612462|NCT02033369|Secondary|Change in Temporal Experiences of Pleasure Scale -- Consummatory Subscale|"A validated self-rated scale shown to assess consummatory pleasure. It will be used for exploratory analyses of anhedonia.~18 items were measured on a scale of 1 (very false for me) to 6 (very true for me). Higher scores indicate higher pleasure. Item scores were added for a lowest possible score of 18 and highest possible score of 108."|Baseline and 6 weeks|Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.|||units on a scale||Standard Deviation|Mean
2612463|NCT02033369|Secondary|Change in Clinical Global Improvement - Severity Scale|Seven-point Likert scale rating clinical severity of mental illness from 1 (least severe) to 7 ( most severe). Physician-rated scale. One item.|6 weeks|Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.|||units on a scale||Standard Deviation|Mean
2612464|NCT02033369|Secondary|Change in the Apathy Evaluation Rating Scale|A validated self-rated 18 item scale assessing apathy. Items were rated from 1 (not at all true) to 4 (very true). Higher scores indicate lower apathy, lower scores indicate higher apathy. Lowest possible score is 18, highest possible score is 72.|Baseline and 6 weeks|Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.|||units on a scale||Standard Deviation|Mean
2612465|NCT02033369|Secondary|Change in Mood and Anxiety Symptom Questionnaire, Short Form|Change in Mood and Anxiety Symptom Questionnaire, Short Form. A 62-item scale assessing anxiety and depression. Items were measured on a scale of 1-5, higher number indicating higher levels of symptoms.The lowest possible score was 62, and the highest 310.|Baseline and 6 weeks|Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.|||units on a scale||Standard Deviation|Mean
2612488|NCT02033005|Secondary|Change in Regional Adipose Tissue Distribution Compared to Breastfed Infants.|Change in regional adipose tissue distribution (ratio of internal abdominal to total subcutaneous abdominal adipose tissue) measured using whole body magnetic resonance imaging|Between birth and 6-12 weeks age||||no unit (ratio)||Inter-Quartile Range|Median
2612466|NCT02033369|Secondary|Change in Temporal Experience of Pleasure Scale - Anticipatory Subscale|"A validated self-rated scale shown to assess anticipatory pleasure. It will be used for exploratory analyses of anhedonia.~18 items were measured on a scale of 1 (very false for me) to 6 (very true for me). Higher scores indicate higher pleasure. Item scores were added for a lowest possible score of 18 and highest possible score of 108."|Baseline and 6 weeks|Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.|||units on a scale||Standard Deviation|Mean
2612467|NCT02033369|Secondary|Change in Snaith Hamilton Pleasure Scale|"Fourteen-item self-rated anhedonia scale. Items were comprised of statements that participants rated as strongly disagree (1), disagree (2), agree (3), or strongly agree (4). The lowest possible score was 14, the highest possible score was 56."|Baseline and 6 weeks|Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.|||units on a scale||Standard Deviation|Mean
2612468|NCT02033369|Primary|Change in Hamilton Rating Scale for Depression|Hamilton Rating Scale for Depression (HRSD), 17-item version. This standard scale will be used to assess severity of depression, looking at change in total score from baseline to week 6, rating severity of depression on a scale from 0 (least depression) to 50 (greatest depression)|Baseline and 6 weeks|Healthy control subjects were not assessed for outcome measures because by study design they received no therapeutic intervention.|||units on a scale||Standard Deviation|Mean
2612469|NCT02033317|Primary|Change From Baseline in Fecal Potassium Excretion (Day -7 Through Day -1) and Treatment (Day 1 Through 7)||Day -7 Through Day -1 and Day 1 Through Day 7||||mg/Day||Standard Deviation|Mean
2612470|NCT02033317|Primary|Change in Serum Potassium (Day 1 to Day 8)||Day 1 and Day 8||||mmol/L||Standard Deviation|Mean
2612471|NCT02033213|Secondary|Total Volume of Administered Intraoperative Fluid|Total volume of intraoperatively given fluid according to the protocol will be measured and compared between two groups.|End of surgery||||milliliters||Standard Deviation|Mean
2612472|NCT02033213|Secondary|Duration of Surgery|Total time of Lewis-Tanner procedure will be measured and compared between two groups.|End of surgery.||||minutes||Standard Deviation|Mean
2612473|NCT02033213|Primary|Changes in Lactate Levels During Esophageal Carcinoma Surgery Using Restrictive or Liberal Fluid Management.|At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared inside the same group (liberal or restrictive).|10 minutes, 6 hours||||mmol/L||Standard Deviation|Mean
2612474|NCT02033213|Primary|Lactate Values During and After Esophageal Carcinoma Surgery|At the given time points, ten minutes after beginning of the Lewis Tanner procedure and six hours after procedure, blood levels of the lactate will be measured and compared between two groups for each time point separately.|10 minutes, 6 hours||||mmol/L||Standard Deviation|Mean
2612475|NCT02033213|Primary|Creatinine Values During and After Esophageal Carcinoma Surgery|At the given time points, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, creatinine blood levels will be measured. The results will be compared between two groups for each time point separately.|10 minutes, 6 hours||||μmol/L||Standard Deviation|Mean
2612476|NCT02033213|Primary|Pulmonary Gas Exchange During and After Esophageal Carcinoma Surgery (PaO2/FiO2 Ratio)|At the given time point, 10 minutes after beginning of the Lewis Tanner procedure and 6 hours after, arterial oxygen partial pressure (PaO2), inspired oxygen fraction (FiO2), and the PaO2/FiO2 ratio will be measured. The results of Pa02/FiO2 ratio will be compared between two groups for each time point separately.|10 minutes, 6 hours||||mmHg||Standard Deviation|Mean
2612477|NCT02033200|Secondary|Change From Baseline in Intraocular Pressure 24 Hour Post Dosing|Intraocular pressure was measuring using the Goldman applanation tonometry|24 hours||||mm Hg||Standard Deviation|Mean
2612478|NCT02033200|Secondary|Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing||24 hours||||total error score||Standard Deviation|Mean
2612479|NCT02033200|Secondary|Change From Baseline in Pupil Dilation 24 Hour Post Dosing||24 hour||||mm||Standard Deviation|Mean
2612480|NCT02033200|Secondary|Change From Baseline in Visual Acuity 24 Hours Post Dosing||24 hours||||LogMar||Standard Deviation|Mean
2612481|NCT02033200|Primary|Change From Baseline in Intraocular Pressure 1 Hour Post Dosing|Intraocular Pressure was measured using the Goldman applanation tonometry|1 hour||||mm Hg||Standard Deviation|Mean
2612482|NCT02033200|Primary|Change From Baseline in Pupil Dilation 1 Hour Post Dosing|Pupil dilation was measured using the Neuroptics Model VIP 200 pupillometer under standard lighting conditions.|1 hour||||millimeter||Standard Deviation|Mean
2612483|NCT02033200|Primary|Change From Baseline in Visual Acuity 1 Hour Post Dosing|Visual acuity was measured using the Logarithm of the Minimum Angle Resolution (LogMAR) chart. The LogMAR value of the best line read was noted and the number of letters read in the next row was multiplied by 0.02, then subtracted from the LogMAR value of the best line completely read.|1 hour||||LogMar||Standard Deviation|Mean
2612484|NCT02033200|Primary|Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing|Color vision discrimination was performed using the Lanthony 40-Hue Test according to Farnsworth-Munsell 100-Hue Test. The total error score was derived by counting the number of caps misplaced.|1 hour||||total error score||Standard Deviation|Mean
2612485|NCT02033174|Primary|Change From Baseline in Concentrations of Antioxidant Profile After Red Wine Intake|In order to determine total antioxidant capacity a quantitative immunoassay using commercial kits (R&D Systems, Inc. Minneapolis, USA) was conducted.|Baseline and 5 days|All participants who completed all study visits were included|||percentage of change in TAC||Inter-Quartile Range|Median
2612486|NCT02033083|Primary|D&E Procedure Time|Length of D&E procedure in minutes|The primary outcome measure will be assessed on the day of the patient's D&E procedure. (day 2)||||minutes||Standard Deviation|Mean
2612487|NCT02033005|Secondary|Change in Intrahepatocellular Lipid Compared to Breastfed Infants.|Change in intrahepatocellular lipid (IHCL) compared to breastfed infants, measured using in-vivo hepatic magnetic resonance spectroscopy|Between birth and 6-12 weeks age|Reduced number of participants due to missing intrahepatocellular lipid data in some cases|||difference in ratio CH2 to water||Inter-Quartile Range|Median
2612787|NCT02029521|Secondary|Forced Vital Capacity|Percent predicted of forced vital capacity.|6 months|PFT's not done on children under age of 5.|||Percent Predicted||Standard Deviation|Mean
2612490|NCT02032901|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From Day 1 first dose to last dose plus 7 days|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.|||Participants|||Number
2612491|NCT02032901|Primary|Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.|||percentage of participants||95% Confidence Interval|Number
2612492|NCT02032901|Secondary|Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12)|Participants categorized into 2 genotypes (CC and non-CC) based on SNPs in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus (HCV) RNA levels below lower limit of quantitation (LLOQ) below target detected or target not detected at follow-up Week 12 (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, ''n'' signifies number of participants evaluable for the specified category.|||Percentage of participants||95% Confidence Interval|Number
2612493|NCT02032901|Secondary|Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie. 25 IU/mL, target detected or target not detected at follow-up Week 12. Cirrhosis was considered a negative predictor of SVR in participants treated with an interferon formulation or ribavirin. Presence or absence of cirrhosis was determined at baseline and follow-up Week 12 in the participants to evaluate the post-treatment relapse.|Baseline, Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The 'n' signifies the number of evaluable participants with or without cirrhosis in the reporting arm and time point, respectively.|||Percentage of participants||95% Confidence Interval|Number
2612494|NCT02032901|Secondary|Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)|Percentage of participants who achieved HCV RNA <LLOQ,TD or TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.|||Percentage of participants||95% Confidence Interval|Number
2612495|NCT02032901|Secondary|Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)|Percentage of participants who achieved HCV RNA <LLOQ, TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 1, 2, 6, 8 (treatment period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.|||Percentage of participants||95% Confidence Interval|Number
2612496|NCT02032901|Secondary|Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND)|EOTR were defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Up to the end of treatment (up to 24 weeks)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.|||percentage of participants||95% Confidence Interval|Number
2612497|NCT02032901|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND)|cEVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.|||Percentage of participants||95% Confidence Interval|Number
2612498|NCT02032901|Secondary|Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)|RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.|||Percentage of participants||95% Confidence Interval|Number
2612499|NCT02032901|Primary|Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.|||Percentage of participants||95% Confidence Interval|Number
2612500|NCT02032888|Secondary|Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results|Grade 3-4 abnormalities on laboratory test results were defined as: International normalized ratio as 2.1-3.0*upper limit of normal (ULN) for grade 3 and >3.0*ULN for grade 4. Leukocytes as 1.0*10^9-1.5*10^9/L for grade 3 and <1.0*10^9/L for grade 4. Aspartate aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4. Bilirubin (total) as 2.6-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Lipase (total) as 3.1-5.0*ULN for grade 3 and >5.0*ULN for grade 4. Alanine aminotransferase as 5.1-10.0*ULN for grade 3 and >10.0*ULN for grade 4.|From screening up to week 24 of post treatment follow--up|All participants who received at least 1 dose of study drug|||Participants|||Number
2612501|NCT02032888|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|AEs: Day 1 of follow-up period (Week 9 or Week 13) to 7 days after end of 24 weeks follow-up period. SAEs: Day 1 of follow-up period (Week 9 or Week 13) to 30 days after end of 24 weeks follow-up period.|All participants who received at least 1 dose of study drug|||Participants|||Number
2612502|NCT02032888|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|AEs: Day 1 to 7 days after last dose of study treatment (8 weeks or 12 weeks). SAEs: Day 1 to 30 days after last dose of study treatment (8 weeks or 12 weeks)|All participants who received at least 1 dose of study drug.|||Participants|||Number
2612503|NCT02032888|Secondary|Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR is defined as hepatitis C virus RNA <lower limit of quantitation, target detected or target not detected at follow-up Week 12. Percentage calculated as number of responders/number of patients receiving treatment.|At Follow-up Week 12|All participants who received at least 1 dose of study drug. n=participants with CC or non-CC Genotype.|||Percentage of participants||95% Confidence Interval|Number
2612504|NCT02032888|Secondary|Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)|Participants with HCV RNA levels <LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment|All participants who received at least 1 dose of study drug|||Percentage of participants||95% Confidence Interval|Number
2612505|NCT02032888|Secondary|Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24|Participants with hepatitis C virus CV) levels to be <lower limit of quantitation, TD or TND at each visit. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24|All participants who received at least 1 dose of study drug|||Percentage of participants||95% Confidence Interval|Number
2612506|NCT02032888|Secondary|Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12)|SVR12 was defined as HCV RNA levels <lower limit of quantitation, target detected or target not detected. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|At follow-up Week 12|All participants who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2612507|NCT02032888|Secondary|Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as HCV RNA <lower limit of quantitation, target detected or target not detected, at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|At follow-up Week 12|All treatment-experienced participants coinfeted with HCV/HIV who received at least 1 dose of study therapy. Here, 'N' signifies the number of participants evaluable for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2612508|NCT02032888|Secondary|Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as HCV RNA<lower limit of quantitation, target detected, or target not detected, at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|At follow-up Week 12|All treatment-naive participants coinfected with genotype 1 HCV and HIV who received at least 1 dose of study therapy. Here, 'N' signifies the number of participants evaluable for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2612509|NCT02032888|Primary|Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as HCV RNA <lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|At follow-up Week 12|All genotype 1 treatment-naive participants who received at least 1 dose of study therapy. Here, 'number of participants analyzed' (N) signifies the number of participants evaluable for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2612788|NCT02029521|Secondary|Bacteriology|Expectorated sputum or throat swab|3 months||||participants|||Number
2612789|NCT02029521|Secondary|FEV1|Forced expiratory volume at one second, percent predicted|3 months|Pulmonary function tests not performed on children under the age of 5|||Percent predicted||Standard Deviation|Mean
2612510|NCT02032875|Secondary|Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities|Grade 3-4 laboratory abnormalities were defined as: Hemoglobin as 6.50-7.4 g/dL for grade 3 and/or < 6.5 g/dL for grade 4, Platelet count as 25*10^9-50*10^9 /L for grade 3 and/or < 25.000*10^9 /L for grade 4, International normalized ratio as 2.1-3.0*upper limit of normal (ULN) > 3.0*ULN for grade 3 and/or > 3.0*ULN for grade 4, Leukocytes as 1.0*10^9-1.5*10^9/L for grade 3 and/or <1.0*10^9/L for grade 4, Lymphocytes (Absolute) as 0.350*109-0.499*10^9 /L for grade 3 and/or < 0.350*10^9 /L for grade 4, Alanine aminotransferase as 5.1-10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Aspartate aminotransferase as 5.1-10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Alkaline phosphatase as 5.1-10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Bilirubin (Total) as 2.6-5.0*ULN for grade 3 and/or > 5.0*ULN for grade 4, Albumin as < 20 g/L, Lipase (Total) as 3.1-5.0*ULN for grade 3 and/or > 5.0*ULN for grade 4, and Creatinine as 1.9-3.4*ULN for grade 3 and/or ≥ 3.5*ULN for grade 4.|From start of study treatment up to 7 days post last dose of study treatment|All treated participants.|||participants|||Number
2612511|NCT02032875|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), AEs Leading to Interruption, Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Death|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|From start of study treatment up to 7 days post last dose of study treatment (approximately 13 weeks)|All treated participants.|||participants|||Number
2612512|NCT02032875|Secondary|Percentage of Participants With CC or Non-CC Genotype Who Achieved Sustained Virologic Response at 12 Weeks After the Last Dose of Study Drug (SVR12)|Participants categorized into 2 genotypes (CC and non-CC) based on single nucleotide polymorphism in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus RNA levels be <lower limit of quantitation ie, 25 IU/mL or below target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|Post-treatment follow-up Week 12|All treated participants. Here, 'n' signifies participants evaluable for SVR12 at the specified time point in each group, respectively.|||Percentage of participants||95% Confidence Interval|Number
2612513|NCT02032875|Secondary|Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment|Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target not detected, at each on-treatment visit.|Week 1, 2, 4, 6, 8, 12, End of treatment|All treated participants.|||Percentage of participants||95% Confidence Interval|Number
2612514|NCT02032875|Secondary|Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24|Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at each visit.|Week 1, 2, 4, 6, 8, 12, End of treatment, Follow-up Week 4, 8, and 24|All treated participants.|||Percentage of participants||95% Confidence Interval|Number
2612515|NCT02032875|Secondary|Percentage of Participants Who Achieved Sustained Virologic Response at Post-treatment Week 12 (SVR12) for All Genotypes and Genotypes 2, 3, 4, 6|SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|Post-treatment follow-up Week 12|All treated participants who took at least 1 dose of study medication. Here, ‘n’ signifies participants evaluable for SVR12 at the specified time point in each group, respectively.|||Percentage of participants||95% Confidence Interval|Number
2612516|NCT02032875|Primary|Percentage of Genotype-1 Infected Cirrhotic Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)|SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|Post-treatment follow-up Week 12|All genotype 1 cirrhotic participants who received at least 1 dose of study therapy.|||Percentage of participants||95% Confidence Interval|Number
2612517|NCT02032875|Primary|Percentage of HCV Genotype-1 Infected Post-liver Transplanted Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12)|SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation (<LLOQ) i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.|Post-treatment follow-up Week 12|All HCV genotype 1 infected post-transplant participants who received at least 1 dose of study therapy.|||Percentage of participants||95% Confidence Interval|Number
2612518|NCT02032810|Secondary|Overall Survival (OS)|Overall survival: The time from randomization until death from any cause.|36 months||||Months||95% Confidence Interval|Median
2612519|NCT02032810|Secondary|Progression Free Survival (PFS)|Progression Free Survival (PFS): is defined for each participant as the time from first dosing to the first observation of disease progression or death due to any cause. If a subject has not progressed or died at the time of analysis, PFS will be censored on the date of the last disease assessment. PFS will be calculated by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions.|Up to 6 months||||Months||95% Confidence Interval|Median
2612520|NCT02032810|Secondary|Immune Related Overall Response Rate (ORR)|Tumor response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related Response Criteria (irRC). RECIST: Best overall response from start of treatment until disease progression/recurrence. Immune-related Complete Response (irCR): Complete disappearance of all tumor lesions for at least 4 weeks from date of documentation of irCR. Immune-related Partial Response (irPR): Sum of the products of the 2 largest perpendicular diameters of all index lesions, measured and captured as the Sum of Product of Diameters (SPD) baseline. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease (PD), taking as reference the smallest sum longest diameter (LD) since the treatment started. Immune-related Progressive Disease (irPD): At least a 25% increase in the SPD of all index lesions and new measurable lesions (irSPD) over the nadir SPD calculated for the index lesions.|Up to 36 months||||Participants|||Count of Participants
2612521|NCT02032810|Primary|Maximum Tolerated Dose (MTD)|"MTD and recommended Phase 2 dose (RP2D) of panobinostat (PAN), administered in combination with ipilimumab (IPI) in participants with unresectable Stage III or Stage IV melanoma.~The goal is to enroll up to 36 patients for determination of the MTD, but will be successfully concluded earlier if 12 patients are accrued at the dose determined to be the MTD, with 3 dose limiting toxicities (DLTs).~All participants who receive study any drug therapy will be evaluated for safety. Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, physical examinations, and clinical laboratory tests. Triplicate 12-lead electrocardiograms (ECGs) will be collected prior to dosing on Day 1 of induction cycle 1. MTD of PAN in milligrams (mg), with IPI at 3 mg/kg."|Up to 36 months|All participants|||mg|||Number
2612522|NCT02032758|Secondary|Mean Total Putter Face Rotation Before Impact|"Total putter face rotation before impact is the degrees of rotation of the putter from the start of the forward swing until the time of impact with the golf ball."|baseline, approximately 45 minutes after propranolol dosing|This variable was measured at baseline and then again approximately 45 minutes after propranolol in the group with golfer's cramp on the same day. The pro golfers did not take propranolol so they were only tested once, at baseline.|||degrees||Standard Deviation|Mean
2612523|NCT02032758|Primary|Mean Dynamic Change of Rotation at Impact|"Dynamic change of rotation at impact is the velocity of rotation of the putter from the start of the forward swing until the time of impact with the golf ball."|baseline, approximately 45 minutes after propranolol dosing|This variable was measured at baseline and then again approximately 45 minutes after propranolol in the group with golfer's cramp on the same day. The pro golfers did not take propranolol so they were only tested once, at baseline.|||degrees/sec||Standard Deviation|Mean
2612524|NCT02032706|Secondary|Assess the Accuracy of Night Shift Measurement of Sleep Efficiency|Compare Sleep Efficiency (SE) obtained from PSG and compared to the Night Shift SE to determine if outliers are within the range (19.1 to -17.2%) defined by the predicate device|one night|Studies included 35 baseline comparisons and 30 comparisons at follow-up|||% studies|||Number
2612525|NCT02032706|Secondary|Assess the Accuracy of Night Shift's Measurement of Total Sleep Time|Compared the Total Sleep Time (TST) from polysomnography to the Night Shift TST to tally the number of records with differences outside the range (151 to -129) defined by the predicate device.|one night|Comparisons included 35 studies at baseline and 30 follow-up studies|||% of studies|||Number
2612526|NCT02032706|Secondary|Assess the Accuracy of Night Shift's Detection of Sleep vs. Wake|Compare the epochs staged wake and sleep by the reference standard (polysomnography) to the epochs staged wake and sleep by Night Shift to determine the sleep (sensitivity) and wake (specificity) classification accuracy.|baseline and follow-up||||percentage of epochs||Standard Deviation|Mean
2612527|NCT02032706|Secondary|Evaluate Impact of Positional Therapy on Quality of Life Scores|Compare the Functional Outcomes of Sleep (FOSQ) scores obtained at baseline and compare to results after 4 weeks of therapy to determine the percentage of compliant participants who demonstrate >2 point improvement. The FOSQ includes thirty questions with numerically scaled responses which are totaled with an overall score of 1 identifying the most impaired and 120 identifying the least impaired.|four weeks||||Percentage of participants|||Number
2612528|NCT02032706|Secondary|Evaluate Efficacy by Confirming Position Therapy Reduces Daytime Somnolence in Patients With Positional OSA|The percentage of compliant participants who show an improved Epworth Sleepiness Score of >= 2 after 4 weeks of therapy when compared to the baseline score. Epworth scores range from 0 (no daytime somnolence) to 21 being extreme somnolence. A difference of 2 or more indicates some positive benefit from therapy.|baseline and followup||||percentage of participants|||Number
2612529|NCT02032706|Secondary|Evaluate Whether Patients Adapt and Sleep Through the Position Therapy Feedback|Evaluate the percent time supine across four weeks of use and confirm that participants average less than 15% time supine across the four weeks of home use|four weeks||||% participants averaged < 15% supine|||Number
2612530|NCT02032706|Secondary|Evaluate Whether Night Shift Disrupts Sleep Such That Users Are Non-compliant|Measure the percentage of nights across the 4 weeks of therapy the Night Shift was worn for a minimum of 5.5 hours/night or the length of time in bed by each participant.|four weeks||||Percent of nights||Full Range|Median
2612531|NCT02032706|Secondary|Confirmation That Night Shift Accurately Detects Supine Position|Compute the percentage of participants at baseline and at followup in which the Night Shift's measurement of the supine position was within+/- 5% of the percent time supine by video recordings plus chest sensor (gold standard).|baseline and 4-weeks later at follow up|35 subjects completed the baseline polysomnography (PSG) while wearing the device. One subject's PSG study was conducted prior to enrollment but qualified as a baseline. 30 subjects completed a follow-up PSG.|||percentage of participants|||Number
2612532|NCT02032706|Primary|Evaluate Efficacy Based on a Change in Obstructive Sleep Apnea (OSA) Severity as a Result of Therapy|Determine the percentage of participants that exhibited at least a 50% reduction in OSA severity measured by AHI after 4 weeks of therapy.|30-days||||percentage of participants|||Number
2612533|NCT02032706|Primary|Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events|Assess the potential for adverse events by evaluating whether more than 20% of participants chose to terminate the study prior to completing 4 weeks of therapy.|Four weeks||||Percentage of participants|||Number
2612790|NCT02029521|Secondary|Forced Vital Capacity|Forced vital capacity percent predicted|3 months|Pulmonary function tests not performed on children under the age of 5|||percent predicted||Standard Deviation|Mean
2612534|NCT02032641|Secondary|Hair Loss|After each laser session, subjects were asked to rate perceived amount of hair loss from both the treated and control scars on a 1-10 scale, with 1 being none at all and 10 being extremely significant|within 1 hour after final treatment|Within 1 hour after treatment, subjects were given a mirror and asked to rate perceived hair loss for each side on a 1-10 scale, with 1 representing none and 10 representing very significant|||units on a scale|BROW|Standard Deviation|Mean
2612535|NCT02032641|Secondary|Overall Appearance|Subjects were asked to rate overall cosmesis of both the treated and control scars on a 1-10 scale, with 1 being extremely poor and 10 being extremely excellent, as rated by participant|10 minutes before first treatment and at the final visit|Patients were asked to grade overall cosmesis of both the treated and control scars on a 1-10 scale, with 1 being extremely poor and 10 being extremely excellent. Grading was done 10 minutes prior to each laser treatment and 4 weeks after final treatment|||units on a scale|BROW|Standard Deviation|Mean
2612536|NCT02032641|Primary|Relative Improvement|Which scar, overall, appears to have improved more from initial to final visit, as rated by blinded examiner of photographs|1 month after final treatment|3 graders masked to treatments were asked to judge side-by-side photographs of first and final visits for which scar improved more. Each pair of before-and-after photos was graded twice by each examiner. Results are percentage of times treated scar was chosen by examiners as most improved (an analysis of 6 results per pair of photos).|||percentage of times treated scar chosen|BROW|Standard Deviation|Mean
2612537|NCT02032433|Secondary|Opioid Abstinence Over Time While on Study Medication (Objective)|A urine sample was obtained and tested for opioids at each in person visit; screening, prior to induction onto study medication, weekly through week 24 and at each of the follow up visits.|Weeks 0-24|Per protocol|||Weeks||Inter-Quartile Range|Median
2612538|NCT02032433|Secondary|Cognitive Function|Cognitive function was assessed via the Trails Making Test, Parts A and B, and the Stroop Color-Word Test. Both assessments were completed at baseline, every 4 weeks through the end of treatment/week 24.|Weeks 0-24|||||||
2612539|NCT02032433|Secondary|HIV Risk Behavior Over Time|HIV and other risk behaviors are assessed via the Risk Assessment Battery (RAB), assessed at baseline, week 12, end of treatment/ week 24 and at each follow up visit.|Weeks 0-36|||||||
2612540|NCT02032433|Secondary|Problems Related to Drug Abuse|Assessed via the ASI-Lite modules, completed at baseline, week 24, and at each of the follow up visits. Assessed by teh EuroQuol (EQ-5D), completed at baseline, then every 4 weeks and at each follow up visit.|Weeks 0-36|||||||
2612541|NCT02032433|Secondary|Subacute Withdrawal Symptoms Over Time|Subacute withdrawal symptoms were assessed via the Subjective Opioid Withdrawal Scale, completed at baseline, before and after induction onto study medication, then weekly for the first 4 weeks, every 4 weeks for weeks 8-24 and at both follow up visits. The Hamilton Depression Scale (HAM-D, 17-item) was completed at screening, weekly for the first 4 weeks and then every four weeks and at both followup visits.|Weeks 0-36|||||||
2612542|NCT02032433|Secondary|Opioid Craving Over Time|Opioid craving was assessed via a Visual Analog Scale (VAS), completed at screening, weekly during treatment, and at each follow up visit.|Weeks 0-36|||||||
2612543|NCT02032433|Secondary|Cigarette Smoking|Cigarette smoking, tobacco use and craving were assessed via the Fagerstrom Test for Nicotine Dependence (FTND) and the Tobacco Use Questionnaire (part of PhenX) at baseline. Craving was assessed via a Visual Analog Scale (VAS), done at screening, every 4 weeks, and at each follow up visit. Number of cigarettes smoked per day was asked at screening, every 4 weeks, and at each follow up visit.|Weeks 0-36|||||||
2612544|NCT02032433|Secondary|Alcohol and Other Drug Use, Over Time|Self report of alcohol and other drug use by participants using TLFB. At each visit the TLFB was completed for dates going back to the last participant encounter. Confirmatory UDS was done at each in person visit.|Weeks 0-36|||||||
2612545|NCT02032433|Secondary|Opioid Abstinence Over Time While on Study Medication (Subjective)|Self report of opioid use by participants using the TLFB. At each visit, the TLFB was completed for dates going back to the last participant encounter.|Weeks 0-24|per protocol|||days||Inter-Quartile Range|Median
2612546|NCT02032433|Secondary|Adverse Events Related to Study Medications|Adverse events reported by participants and assessed by clinical staff for relatedness to study medication. These determinations were reviewed by the study medical monitor.|Weeks 0-36|These are treatment emergent adverse events. Treatment emergence is defined as any adverse events that occurred after the study day of induction for those participants inducted onto study medication.|||events|||Number
2612547|NCT02032433|Secondary|Number Successfully Inducted Onto Assigned Study Medication|Binary Y/N assessment of whether the participant was or was not able to initiate their assigned study medication.|Weeks 0-24|Intent to treat|||participants|||Number
2612548|NCT02032433|Primary|Time to Relapse (Per Protocol Population)|Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.|Weeks 3-24|Per protocol population (those successfully inducted onto medication)|||weeks||95% Confidence Interval|Median
2612549|NCT02032433|Primary|Time to Relapse (Intent to Treat Population)|Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.|Weeks 3-24|Intention to treat.|||weeks||95% Confidence Interval|Median
2612554|NCT02032407|Secondary|ASIS Impact Domain Score|The participant assessed the impact of acne vulgaris using the ASIS. The impact domain is a composite of 8 items assessing the psychosocial impacts (6 items emotional and 2 items social) of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The impact domain score is calculated as the average of the 8 items for a total possible score of 0 to 4. Higher scores on the ASIS Impact Domain indicate greater negative impact of acne on health-related quality of life and appearance.|Weeks 2, 6 and 12|Participants from the mITT population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
2612555|NCT02032407|Secondary|Acne Symptom and Impact Scale (ASIS) Sign Domain Score|The participant assessed signs of acne vulgaris using the ASIS. The sign domain is a composite of 9 items of the 17 items on the overall scale. Each of the items is answered on a 5-point scale: 0 (best) to 4 (worst). The sign domain score is calculated as the average of the 9 items for a total possible score of 0 to 4. Higher scores indicate the presence of more severe signs of acne.|Weeks 2, 6 and 12|Participants from the mITT population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data at the given time-point.|||score on a scale||Standard Deviation|Mean
2612556|NCT02032407|Secondary|Percentage of Participants With 0 (None) or 1 (Minimal) on the GAAS|The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. The percentage of participants with a score of 0=none or 1=minimal is reported.|Weeks 2, 6 and 12|Participants from the mITT, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.|||percentage of participants|||Number
2612557|NCT02032407|Secondary|Percent Change From Baseline in Non-Inflammatory Lesion Counts|The investigator evaluated Non-inflammatory (blackhead and whitehead) lesions. A negative percent change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Weeks 2, 6 and 12|Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.|||percent change||Standard Deviation|Mean
2612558|NCT02032407|Secondary|Percent Change From Baseline in Inflammatory Lesion Counts|The investigator evaluated Inflammatory lesions (papule, pustule and nodule/cyst). A negative percent change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Weeks 2, 6 and 12|Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.|||percent change||Standard Deviation|Mean
2612559|NCT02032407|Secondary|Percent Change From Baseline in Total Lesion Counts|The investigator evaluated Inflammatory (papule, pustule and nodule/cyst) and Non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative percent change from baseline indicates a reduction in lesion counts (improvement).|Baseline, Weeks 2, 6 and 12|Participants from the Modified Intent-to treat (mITT) population, all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment, with data available at the given time-point.|||percent change||Standard Deviation|Mean
2612560|NCT02032407|Secondary|Change From Baseline in the GAAS|The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.|Baseline, Weeks 2 and 6|Modified Intent-to treat (mITT) population included all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
2612561|NCT02032407|Primary|Change From Baseline in the Global Assessment of Acne Severity (GAAS) Score by Physician|The investigator evaluated the participant's acne severity using the 5-point GAAS grading scale: 0= No evidence of facial acne vulgaris to 4= Significant degree of inflammatory disease; papules/pustules were a predominant feature; a few nodulo-cystic lesions could have been present; comedones (small pumps on the skin caused by acne) could have been present. A negative change from Baseline indicated improvement.|Baseline, Week 12|Modified Intent-to treat (mITT) population included all enrolled participants who received at least one application of study treatment and had at least one post-Baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
2612562|NCT02032238|Primary|Percentage of Eyes That Received Retreatment||12 months||||Percentage of eyes that received retreat|||Number
2612563|NCT02032212|Secondary|Nicotine Craving|"Craving was assessed with the Brief Questionnaire of Smoking Urges (QSU-Brief). Subject had to rate 10 statements, such as I have a desire for a cigarette right now, by a number ranging from 1 (strongly disagree) to 7 (strongly agree). Scores can range from a minimum of 0 to a maximum of 70. A higher score means a stronger urge to smoke a cigarette."|30 minutes after the third product use||||score on a scale||Standard Deviation|Mean
2612564|NCT02032212|Secondary|Nicotine Withdrawal Symptoms|Withdrawal symptoms were evaluated with the Minnesota Nicotine Withdrawal Scale questionnaire, to which only the 15 questions of the subject's part were completed. Subjects had to rate behaviours (e.g. angry, irritable, frustrated, depressed, restless, insomnia) from 0 (none) to 4 (severe). A higher score means more severe withdrawal symptoms. Scores range from a minimum of 0 to a maximum of 60.|30 minutes after the third product use||||score on a scale||Standard Deviation|Mean
2612565|NCT02032212|Secondary|Exhaled Carbon Monoxide|Measured with a Smokerlyser device|25 minutes||||ppm||Standard Deviation|Mean
2612568|NCT02031679|Secondary|The Ability of AZD1981 to Inhibit Prostaglandin D2 (PGD2)-Induced Eosinophil Shape|The measure of Eosinophil shape change was assessed by cell scatter characteristics using a flow cytometer. Cellular scatter was established with buffer and then several doses of PGD2 stimulation.|Baseline, End of treatment, end of washout|Insufficient samples were obtained for one active and 2 placebo patients.|||Mean fluorescence units area under curve||Standard Deviation|Mean
2612569|NCT02031679|Secondary|The Number of Participants With Adverse Events|The safety of AZD1981 will be assessed using the following outcome measures: incidence and severity of treatment-emergent adverse events and serious adverse events, clinical laboratory measures, and vital signs. In particular we will measure CBC's with differential at baseline and week 4 and liver function tests every 2 weeks based on past trial experience of dose-related toxicity.|8 weeks||||participants with adverse events|||Number
2612570|NCT02031679|Primary|The Change in Diary-based Clinical Symptoms as Measured by the Urticaria Activity Score 7 (UAS7)|The UAS score, which is the sum of pruritus and hives, will be used to calculate the UAS7. UAS is a validated measure of Chronic Spontaneous Urticaria (CSU) disease activity which scores the intensity of pruritus (0-3, with 0 = no itch and 3 is severe itch) and number of hives (0-3 0 means no hives and 3 means greater than 50 hives) with a maximum value of 6 for a given day. The UAS7 is the sum of the daily average UAS scores (average of a.m. and p.m.) for 7 days with a minimum score of 0 and a maximum value of 42. The UAS7 is a sum of the daily average (average of a.m. and p.m.) for 7 days. The baseline score was established during the second placebo therapy week and compared to the final week of the 4 week active treatment period.|7 Days|One placebo subject had diary data compromised by device malfunction so only full data for 11 subjects were analyzed|||UAS7 Scores||Standard Error|Mean
2612571|NCT02031640|Secondary|Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period|"A count of participants who were withdrawn from the study due to meeting stopping criteria. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient's overall clinical picture is consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety.~An example of alert criteria is:~FEV1 as measured at the study center is below the FEV1 stability limit value calculated at randomization visit (Day 1).~Other criteria as defined in the protocol."|Treatment period: Day 1 up to Week 12|Full analysis set|||Participants|||Count of Participants
2612572|NCT02031640|Secondary|Kaplan-Meier Estimates for Time to Withdrawal From Study Treatment Due to Meeting Stopping Criteria for Worsening Asthma|"Time to withdrawal due to meeting stopping criteria is defined as number of days elapsed from the date of the first dose of double-blind study treatment to the date of withdrawal due to meeting stopping criteria. Stopping criteria are:~FEV1 as measured at the study center is below the FEV1 stability limit value calculated at RV.~Based upon review of patient diary data, the patient has experienced any of the following during any 7-day period:~4+ days in which the highest (of 3 efforts) am PEF fall below the PEF stability limit calculated when randomized. The patient meets with the investigator who determines whether the FEV1 is consistent with worsening asthma;~3+ days in which 12+ inhalations/day of rescue medication were used~2+ days in which the patient experienced a nighttime asthma symptom score of more than 2~Clinical asthma exacerbation requiring (for example) the use of systemic corticosteroids, or the emergency room or hospitalization."|Day 1 - Week 12|Full analysis set; unable to calculate as few patients met stopping criteria|||days||95% Confidence Interval|Median
2612573|NCT02031640|Secondary|Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1-12 Using a Mixed Model for Repeated Measures (MMRM)|Asthma symptom scores are recorded in the patient's diary each morning and each evening before determining PEF and before administration of study or rescue medications. The Daytime Symptom Score (determined in the evening) has a range from 0=No symptoms during the day to 5=Symptoms so severe that I could not go to work or perform normal daily activities. The Nighttime Symptom Score (determined in the morning) has a range from 0=No symptoms during the night to 4=Symptoms so severe that I did not sleep at all. The total daily asthma symptom score is the average of the daytime and the nighttime scores (full scale is 0 - 4.5). The total daily asthma symptom score is missing if either the daytime or nighttime score is missing. Baseline was the average of recorded daily asthma symptom scores over 7 days prior to the first dose of study treatment. The weekly average was the sum of total daily asthma symptom scores over the 7 days divided by the number of non-missing assessments.|Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12|Full analysis set. Analysis used a MMRM with effects due to baseline score, sex, age, time, treatment, and time-by-treatment interaction.|||units on a scale||Standard Error|Least Squares Mean
2612574|NCT02031640|Secondary|Change From Baseline in the Weekly Average of Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol (Number of Inhalations) Over Weeks 1-12 Using a Mixed Model for Repeated Measures (MMRM)|"Change from baseline in the use of rescue medication, albuterol/salbutamol, during the treatment period offers an indication of asthma control. Baseline was defined as the average of recorded daily usage of albuterol/salbutamol inhalation aerosol over the 7 days prior to the first dose of double-blind study treatment, including the morning usage at the randomization visit.~Weekly average rescue medication data was generated using 7-day windows based on analysis days (after the first dose of double-blind study treatment). Weekly average over the 12 week treatment period was performed using a mixed-model for repeated measures (MMRM) with effects due to baseline value, sex, age, time, treatment, and time-by-treatment interaction."|Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12|Full analysis set|||number of inhalations||Standard Error|Least Squares Mean
2612583|NCT02031471|Secondary|Change From Baseline in Patient Fatigue VAS|"The Patient Fatigue VAS assessment represents the participant's assessment of his/her current level of fatigue on a 100 mm horizontal VAS. The extreme left end of the line represents 0=no fatigue and the extreme right end 100=extreme fatigue. A negative change from baseline indicates an improvement."|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2612791|NCT02029521|Primary|BMI Percentile|Body Mass Index percentile adjusted for sex and age. Standard BMI are not available for participants under 2 years of age|3 months|BMI percentile not available for children under 2 years of age.|||Percentile adjusted for age and sex||Standard Deviation|Mean
2612575|NCT02031640|Secondary|Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM)|"A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary.~Baseline in evening PEF is defined as the average of recorded evening PEF assessments over the 7-day window before randomization.~Weekly average PEF data was generated using 7-day windows based on analysis days (after the first dose of double-blind study treatment). PEF over the 12 week treatment period was performed using a mixed-model for repeated measures (MMRM) with effects due to baseline weekly average of daily evening peak PEF, sex, age, treatment, time, and time by treatment interaction."|Baseline: Days -7 to Day -1, Treatment: Day 1 to Week 12|Full Analysis Set|||Liters/minute||Standard Error|Least Squares Mean
2612576|NCT02031640|Secondary|Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM)|"A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. Daily trough morning PEF assessments were taken pre-dose and pre-rescue bronchodilator over the 12-week treatment period. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary.~Baseline in trough morning PEF is defined as the average of recorded trough morning PEF assessments over the 7-day window before randomization, including the morning assessment on Day 1 before randomization.~Weekly average PEF data was generated using 7-day windows based on analysis days (before the first dose of double-blind study treatment). PEF over the 12 week treatment period was performed using a mixed-model for repeated measures (MMRM) with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time by treatment interaction."|Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 2 to Week 12|Full Analysis Set|||Liters/minute||Standard Error|Least Squares Mean
2612577|NCT02031640|Primary|Standardized Baseline-adjusted Trough Morning Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk) )|"Trough morning FEV1 measurements were taken pre-dose and pre-rescue bronchodilator treatment for asthma. The baseline pulmonary function measurement was defined as the measurement obtained at randomization visit (Day 1). Pulmonary function measurements (including FEV1) were obtained electronically by spirometry. All pulmonary function test data were submitted to a central reading center for evaluation. The highest FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 5 attempts) was used.~Baseline-adjusted FEV1 AUEC(0-12wk) were calculated using the trapezoidal rule.~The standardized baseline-adjusted FEV1 AUEC(0-12 wk) accommodates participants who dropped out of the study. Baseline-adjusted FEV1 AUEC(0-t weeks)/t, where t =12 weeks for patients who complete the FEV1 assessment at Week 12. For participants who dropped out early, t <12 weeks (2, 4, or 8 weeks)."|Day 1 (baseline), Weeks 2, 4, 8, 12|Full analysis set- randomized patients with at least 1 dose of drug and 1 postbaseline trough am FEV1|||Liters||Standard Error|Least Squares Mean
2612578|NCT02031471|Secondary|Safety: Percentage of Participants With Anti-tocilizumab Antibodies||Baseline, Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.|||percentage of participants|||Number
2612579|NCT02031471|Secondary|Safety: Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to 52 weeks|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab.|||percentage of participants|||Number
2612580|NCT02031471|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM ) Scores|The abbreviated 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) derived from the TSQM Version 1.4 but without the five items of the side effects domain, is a reliable and valid measure to assess participants' satisfaction with treatment. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. Domains included are effectiveness, convenience and global satisfaction.|Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2612581|NCT02031471|Secondary|Change From Baseline in Work Instability Scale for Rheumatoid Arthritis (RA-WIS)|The 23-item RA-WIS is a simple, validated screening tool for work instability, i.e., the consequences of a mismatch between an individual's functional ability and their work tasks. This self-administered questionnaire covers a broad range of specific work-related issues and enables monitoring the risk of work disability in rheumatoid arthritis patients. The RA-WIS is scored by summing responses from all 23 scale items. The scale ranges from 0 to 23. Cut points have been established to differentiate levels of work instability: low < 10, moderate 10-17 and high > 17. A negative change from baseline indicates an improvement.|From Baseline to Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2612582|NCT02031471|Secondary|Change From Baseline in Patient Satisfaction VAS|"The Patient Satisfaction VAS assessment represents the participant's assessment of his/her current satisfaction with treatment on a 100 mm horizontal VAS. The extreme left end of the line represents 0=no satisfaction and the extreme right end 100=extremely satisfied. A positive change from baseline indicates an improvement."|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2612792|NCT02029521|Primary|Height Percentile|Height Percentile adjusted for sex and age|3 months|All participants.|||Percentile adjusted for age and sex||Standard Deviation|Mean
2612584|NCT02031471|Secondary|Change From Baseline in Arthritis Impact Measurement Scale-Short Form (AIMS-SF)|The AIMS-SF is a reduced version of the validated AIMS2 questionnaire. The Short Form has been developed using a comprehensive expert-based approach and supported by psychometric testing. The AIMS-SF is a self-administered questionnaire to measure changes in global health, pain, mobility and social function in adult patients with arthritis and reports scores for physical, symptoms, affect, social and work assessments. Scores range from 0 to 10, higher scores indicating higher impact of arthritis on the assessments. A negative change from baseline indicates an improvement.|From Baseline to Week 4, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2612585|NCT02031471|Secondary|Change From Baseline in Patient Quality of Sleep VAS|"The Patient Quality of Sleep VAS assessment represents the participant's assessment of his/her current quality of sleep on a 100 mm horizontal VAS. The extreme left end of the line represents 0=no difficulty to sleep and the extreme right end 100=extreme sleeping difficulties. A negative change from baseline indicates an improvement."|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2612586|NCT02031471|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI)|"The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over 1-month time interval. Nineteen individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The participant self-rates each of these seven areas of sleep. Scoring of answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. Global scores range from 0 to 21 and a global sum of 5 or greater indicates a poor sleeper. Although there are several questions that request the evaluation of the participant's bed mate or roommate, these are not scored. A negative change from baseline indicates an improvement."|From Baseline to Week 4, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2612587|NCT02031471|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)|The symptom-specific measure FACIT-F was developed to assess chronic illness therapy with special emphasis on fatigue in the past 7 days. In this study, only the FACIT-F short questionnaire, which is a shorter version of the initial FACIT-F questionnaire, was used. Each of the questions is categorically answered using the scales 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. The figures are reversed during score calculations, so that higher score values indicate more favorable conditions. The 13 items included in the FACIT-F short can be used to calculate the brief score for FACIT-F scale (score range: 0-52). A positive change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2612588|NCT02031471|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)|The Stanford HAQ-DI is a patient-oriented outcome assessment questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities. Each category contains multiple questions, which were answered using a 4-point scale from 0 to 3. The overall index score was an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2612589|NCT02031471|Secondary|Acute Phase Reactants: Change From Baseline in ESR|A negative change from baseline in ESR indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||millimeters per hour (mm/hr)||Standard Deviation|Mean
2612590|NCT02031471|Secondary|Acute Phase Reactants: Change From Baseline in CRP|A negative change from baseline in CRP level indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||milligrams per liter (mg/L)||Standard Deviation|Mean
2612591|NCT02031471|Secondary|Change From Baseline in Patient's Assessment of Pain VAS|"Patient's Assessment of Pain VAS represents the participant's assessment of his/her current level of pain on a 100 mm horizontal VAS. The extreme left end of the line represents 0=no pain and the extreme right end 100=unbearable pain. A negative change from baseline indicates an improvement."|From Baseline to Week 2 and Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2612592|NCT02031471|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity VAS|"PGA VAS represents the participant's overall assessment of their current disease activity on a 100 mm horizontal VAS. The extreme left end of the line represents 0= no disease activity (symptom-free and no arthritis symptoms) and the extreme right end 100=maximum disease activity (maximum arthritis disease activity). A negative change from baseline indicates an improvement."|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2612793|NCT02029521|Primary|Weight Percentile at 3 Months|Weight Percentile at 3 months adjusted for sex and age|3 months|All participants.|||Weight Percentile, sex and age adjusted||Standard Deviation|Mean
2612593|NCT02031471|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity VAS|"Physician's Global Assessment of disease activity VAS represents the physician's assessment of the participant's current disease activity on a 100 mm horizontal VAS. The extreme left end of the line represents 0= no disease activity (symptom-free and no arthritis symptoms) and the extreme right end 100= maximum disease activity. This was completed by the Treating Physician (or designee). A negative change from baseline indicates an improvement."|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2612594|NCT02031471|Secondary|Percentage of Participants Achieving a Clinically Significant Improvement in DAS28|The DAS28 score is a measure of the participant's disease activity calculated using TJC28, SJC28, PGA VAS with 0=no disease activity to 100=maximum disease activity displayed on the 100-millimeter (mm) horizontal VAS and acute phase reactant (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]) for a total possible score of 0 to 10. For this study ESR was used to calculate the DAS28 score. The index is calculated using the following formula: DAS28 = (0.56*√[TJC28]) + (0.28*√[SJC28]) + (0.70*ln[ESR]) + (0.014*VAS). Higher scores represent higher disease activity. DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.|||percentage of participants|||Number
2612595|NCT02031471|Secondary|Percentage of Participants Achieving DAS28-ESR Remission, DAS28-ESR LDA, Moderate Disease Activity and High Disease Activity|The DAS28 score is a measure of the participant's disease activity calculated using TJC28, SJC28, PGA VAS with 0=no disease activity to 100=maximum disease activity displayed on the 100-millimeter (mm) horizontal VAS and acute phase reactant (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]) for a total possible score of 0 to 10. For this study ESR was used to calculate the DAS28 score. The index is calculated using the following formula: DAS28 = (0.56*√[TJC28]) + (0.28*√[SJC28]) + (0.70*ln[ESR]) + (0.014*VAS). Higher scores represent higher disease activity. Clinical remission = score <2.6; Low disease activity = score ≥2.6 and ≤3.2; Moderate disease activity = score > 3.2 and ≤5.1; High disease activity = score >5.1.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.|||percentage of participants|||Number
2612596|NCT02031471|Secondary|Percentage of Participants Achieving SDAI Remission, SDAI LDA, Moderate Disease Activity and High Disease Activity|SDAI is calculated by simple arithmetical addition of TJC28 and SJC28, PGA VAS and Physician Global Assessment of disease activity VAS, and CRP concentration in mg/L. VAS range was 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS. Total SDAI score ranges from 0 to 86 with higher scores indicating increased disease activity. Clinical remission = score ≤ 3.3; Low disease activity = score > 3.3 and ≤ 11.0; Moderate disease activity = score > 11.0 and ≤ 26.0; high disease activity = score > 26.0.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.|||percentage of participants|||Number
2612597|NCT02031471|Secondary|Percentage of Participants Achieving CDAI Remission, CDAI Low Disease Activity, Moderate Disease Activity and High Disease Activity|CDAI is calculated by simple arithmetical addition of TJC28 and SJC28, PGA VAS and Physician Global Assessment of disease activity VAS. VAS range was 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS. Total CDAI score ranges from 0 to 76 with higher scores indicating increased disease activity. Clinical remission = score ≤ 2.8; Low disease activity = score > 2.8 and ≤ 10.0; Moderate disease activity = score > 10.0 and ≤ 22.0; High disease activity = score > 22.0.|Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.|||percentage of participants|||Number
2612598|NCT02031471|Secondary|Percentage of Participants With Corticosteroid Dose Reduction/Discontinuation||Up to Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2612599|NCT02031471|Secondary|Change in Total Tender/Swollen Joint Counts (TJC/SJC)|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints were not taken into consideration for swelling or tenderness. A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure|||Joint Counts||Standard Deviation|Mean
2612600|NCT02031471|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI)/Clinical Disease Activity Index (CDAI)|SDAI is a similar index to DAS28 but has the advantage of not needing a complicated mathematical formula for its determination, but a simple arithmetical addition of TJC28 and SJC28, PGA VAS and Physician Global Assessment of disease activity VAS, and CRP concentration in mg/L. CDAI does not incorporate an acute response, therefore it can be used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. VAS range for all assessments was 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS. SDAI scores ranged from 0 to 86, CDAI from 0 to 76 with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement.|From Baseline to Week 2, Week 24 and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2612794|NCT02029495|Secondary|Psoriasis Area and Severity Index (PASI)75|PASI75 indicates that the subject has had a response of a 75% reduction on the severity of the psoriasis area based of off effected area size, erythema, scaling, and itching.|16 Weeks||||percentage of participants||95% Confidence Interval|Number
2612601|NCT02031471|Secondary|Percentage of Participants With Responses According to European League Against Rheumatism (EULAR ) Criteria|EULAR response was calculated as the difference between DAS28-ESR scores at baseline and Week 24, and reported as the percentage of participants with good, moderate, or no response. Good responders = decrease from baseline >1.2 with a DAS28 score of <=3.2; moderate responders = decrease from baseline >1.2 with a DAS28 score of >3.2, or decrease from baseline >0.6 to <=1.2 with a DAS28 score of <=5.1; non-responders = decrease from baseline <=0.6 or decrease from baseline >0.6 and <=1.2 with a DAS28 score of >5.1.|From Baseline to Week 2, Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||percentage of participants|||Number
2612602|NCT02031471|Secondary|Percentage of Participants With Positive American College of Rheumatology (ACR) Response Scores|The ACR core set of outcome measures and their definition of improvement includes a >= 20% improvement (ACR20) compared to Baseline in both SJC and TJC as well as in three out of five additional parameters: Physician's Global Assessment of disease activity VAS, PGA VAS, patient's assessment of pain VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI), and acute phase reactant (CRP or ESR). VAS range for all assessments was 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS. Achievement of an ACR50 requires a >= 50% improvement in the same parameters and an ACR70 requires a >= 70% improvement.|From Baseline to Week 2, Week 24, and Week 52|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here, n is the number of participants with evaluable data for this outcome measure.|||percentage of participants|||Number
2612603|NCT02031471|Primary|Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score in the Per Protocol Set (PPS)|The DAS28 score is a measure of the participant's disease activity calculated using the TJC28, SJC28, PGA VAS with 0=no disease activity to 100=maximum disease activity displayed on the 100-mm horizontal VAS and acute phase reactant (ESR or CRP) for a total possible score of 0 to 10. For this study ESR was used to calculate the DAS28 score. The index is calculated using the following formula: DAS28 = (0.56*√[TJC28]) + (0.28*√[SJC28]) + (0.70*ln[ESR]) + (0.014*VAS). Higher scores represent higher disease activity. A negative change from baseline indicates an improvement.|From baseline to Week 24|The PPS consisted of all participants of the FAS having a value at baseline and at Week 24 for the endpoint DAS28-ESR, excluding sponsor defined deviation(s) which could have affected the evaluation of the primary endpoint (DAS28-ESR). Here, n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2612604|NCT02031471|Primary|Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score in the Full Analysis Set (FAS)|The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count of 28 joints (TJC28), swollen joint count of 28 joints (SJC28), patient's global assessment of disease activity visual analog scale (PGA VAS) with 0=no disease activity to 100=maximum disease activity displayed on the 100-millimeter (mm) horizontal VAS and acute phase reactant (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]) for a total possible score of 0 to 10. For this study ESR was used to calculate the DAS28 score. The index is calculated using the following formula: DAS28 = (0.56*√[TJC28]) + (0.28*√[SJC28]) + (0.70*ln[ESR]) + (0.014*VAS). Higher scores represent higher disease activity. A negative change from baseline indicates an improvement.|From baseline to Week 24|The FAS consisted of all participants included in the study who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2612605|NCT02031458|Secondary|Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per Modified RECIST v1.1|PD was defined as at least 20% increase from nadir in the sum of diameters of new and/or existing target lesions (with an absolute increase of at least 5 mm).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed at the specified time point.|||percentage of participants|||Number
2612606|NCT02031458|Secondary|Percentage of Participants With Event (Disease Progression or Death) as Assessed by INV Per RECIST v1.1|PD was defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5 mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed at the specified time point.|||percentage of participants|||Number
2612607|NCT02031458|Secondary|Percentage of Participants With Event (Disease Progression or Death) as Assessed by IRF Per RECIST v1.1|PD was defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5 mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed at the specified time point.|||percentage of participants|||Number
2612608|NCT02031458|Secondary|Percentage of Participants With Positive Anti-Therapeutic Antibody (Anti-Atezolizumab Antibody) Status|Anti-therapeutic antibodies is a measurement to explore the potential relationship of immunogenicity response with pharmacokinetics, safety and efficacy.|Baseline, post-baseline (up to 16 months)|Efficacy evaluable population; n = number of participants analyzed at the specified time point. Number of participants analyzed = number participants who were evaluable for this outcome.|||percentage of participants|||Number
2612609|NCT02031458|Secondary|Atezolizumab Serum Concentrations|Serum concentrations were determined for all participants after administration of atezolizumab up to Cycle 8. Time (T) = time from first dose in days.|Pre-dose (hour 0) and 0.5 hours post dose on Cycle 1 Day 1 (Cycle length = 21days), Cycle 1 Days 2, 4, 8, 15, and 21, Cycle 2 Day 21, Cycle 3 Day 21, Cycle 7 Day 21|Pharmacokinetic evaluable population; n = number of participants analyzed for the specified time point.|||micrograms per milliliter (μg/mL)||Standard Deviation|Mean
2612610|NCT02031458|Secondary|TIR as Assessed by IRF Per RECIST v1.1|TIR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. For responders, TIR was the same as DOR; for non-responders, TIR was considered as an event and defined as the date of first treatment plus one day. TIR was assessed by Kaplan-Meier estimates.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population|||months||95% Confidence Interval|Median
2612611|NCT02031458|Secondary|TIR as Assessed by INV Per Modified RECIST|TIR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by modified RECIST. For responders, TIR was the same as DOR; for non-responders, TIR was considered as an event and defined as the date of first treatment plus one day. TIR was assessed by Kaplan-Meier estimates.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population|||months||95% Confidence Interval|Median
2612612|NCT02031458|Secondary|Time in Response (TIR) as Assessed by INV Per RECIST v1.1|TIR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. For responders, TIR was the same as DOR; for non-responders, TIR was considered as an event and defined as the date of first treatment plus one day. TIR was assessed by Kaplan-Meier estimates.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population|||months||95% Confidence Interval|Median
2612613|NCT02031458|Secondary|PFS: Percentage of Participants Alive and Progression Free at 12 Months|PD is defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.|Month 12|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||percentage of participants||95% Confidence Interval|Number
2612614|NCT02031458|Secondary|PFS: Percentage of Participants Alive and Progression Free at 6 Months|PD is defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions.|Month 6|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||percentage of participants||95% Confidence Interval|Number
2612615|NCT02031458|Secondary|Percentage of Participants Without an Event (Death) at 12 Months||Month 12|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||percentage of participants||95% Confidence Interval|Number
2612616|NCT02031458|Secondary|Percentage of Participants Without an Event (Death) at 6 Months||Month 6|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||percentage of participants||95% Confidence Interval|Number
2612617|NCT02031458|Secondary|Overall Survival : Median Time to Event (Death)|Overall survival is measured as interval between the first dose of atezolizumab and date of death from any cause.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||months||95% Confidence Interval|Median
2612618|NCT02031458|Secondary|Overall Survival : Percentage of Participants Without Event (Death)||Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||percentage of participants|||Number
2612619|NCT02031458|Secondary|PFS as Assessed by INV Per Modified RECIST|PFS is the interval between the first dose of atezolizumab and date of disease progression or death due to any cause, whichever occurred first as measured by modified RECIST. PD: at least 20% increase from nadir in the sum of diameters of new and/or existing target lesions (with an absolute increase of at least 5mm). PFS was assessed by Kaplan-Meier estimates.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||months||95% Confidence Interval|Median
2612620|NCT02031458|Secondary|PFS as Assessed by INV Per RECIST v1.1|PFS is the interval between the first dose of atezolizumab and date of disease progression or death due to any cause, whichever occurred first as measured by RECIST v1.1. PD: one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. PFS was assessed by Kaplan-Meier estimates.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||months||95% Confidence Interval|Median
2612621|NCT02031458|Secondary|Progression Free Survival (PFS) as Assessed by IRF Per RECIST v1.1|PFS is the interval between the first dose of atezolizumab and date of disease progression or death due to any cause, whichever occurred first as measured by RECIST v1.1. PD is defined as one or more of the following: at least 20% increase from nadir in the sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. PFS was assessed by Kaplan-Meier estimates.|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||months||95% Confidence Interval|Median
2612622|NCT02031458|Secondary|DOR as Assessed by INV Per Modified RECIST|DOR is the interval between the date of the first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and the first date that PD or death is documented, whichever occurs first as measured by modified RECIST. CR: disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: at least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR; PD: one or more of the following: at least 20% increase from nadir in the sum of diameters of existing and/or new target lesions (with an absolute increase of at least 5mm). DOR was assessed by Kaplan-Meier estimates. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group. Number of participants analyzed = overall number of participants who were evaluable for this outcome|||months||95% Confidence Interval|Median
2612623|NCT02031458|Secondary|DOR as Assessed by INV Per RECIST v1.1|DOR is interval between date of the first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: > or = 30 % decrease from baseline in sum of diameters of target lesions, non-PD non-target lesions and no new lesions; PD: one or more of the following: at least 20% increase from nadir in sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. DOR was assessed by Kaplan-Meier estimates. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group. Number of participants analyzed = overall number of participants who were evaluable for this outcome.|||months||95% Confidence Interval|Median
2612624|NCT02031458|Secondary|Duration of Response (DOR) Assessed by IRF Per RECIST v1.1|DOR is interval between date of first occurrence of a CR or PR that is subsequently confirmed (whichever status is recorded first) and the first date that PD or death is documented, whichever occurs first as measured by RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: > or = 30 % decrease from baseline in sum of diameters of target lesions, non-PD non-target lesions and no new lesions; PD: one or more of the following: at least 20% increase from nadir in sum of diameters of target lesions (with an absolute increase of at least 5mm), appearance of new lesions, and/or unequivocal progression of non-target lesions. DOR was assessed by Kaplan-Meier estimates. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group. Number of participants analyzed = overall number of participants who were evaluable for this outcome.|||months||95% Confidence Interval|Median
2612625|NCT02031458|Secondary|Percentage of Participants Achieving Objective Response Per Modified RECIST as Assessed by the INV|ORR was the percentage of participants whose confirmed best overall response was either a PR or a CR based upon the Investigator assessment per modified RECIST. CR: disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n= number of participants analyzed within the specified group.|||percentage of participants||95% Confidence Interval|Number
2612626|NCT02031458|Secondary|Percentage of Participants Achieving Objective Response Per RECIST v1.1 as Assessed by the Investigator (INV)|ORR was the percentage of participants whose confirmed best overall response was either a PR or a CR based upon the Investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10mm; PR: > or = 30 % decrease from baseline in sum of diameters of target lesions, non-PD non-target lesions and no new lesions. Results were reported by line of therapy (reporting arms) and PD-L1 Expression Subgroup (TC3 or IC3, TC3 or IC2/3, TC2/3 or IC2/3).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; n = number of participants analyzed within the specified group.|||percentage of participants||95% Confidence Interval|Number
2612636|NCT02031432|Other Pre-specified|Weekly Average Number of Breakthrough Pain Episodes|The number of episodes of breakthrough pain during the past week was planned to be collected. However, for some participants, the intensity of breakthrough pain for the past week has been collected instead of the incidence of breakthrough pain events. Since the values of the intensity of breakthrough pain were much higher (maximum of up to 99) than the frequency of pain events, the mean is skewed and cannot be interpreted. The median for the weekly average number of breakthrough pain episodes is less influenced by these values and is reported below.|Baseline (Day 1); End of Treatment (Week 26)|Safety Set; 61 participants completed End of Treatment Visit|||Weekly average number of episodes||Full Range|Median
2612838|NCT02028676|Secondary|Cotrimoxazole: Change From Baseline in Absolute CD4 to Week 72|Estimated in those >5 years at randomization to stop vs continue, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)|Baseline, week 72|All participants aged >5 years at randomization to stop versus continue alive in follow-up with CD4 measured|||cells per mm3||Standard Deviation|Mean
2612627|NCT02031458|Primary|Percentage of Participants Achieving Objective Response (ORR) Per Response Evaluation Criteria In Solid Tumors (RECIST) Version (v) 1.1 as Assessed by Independent Review Facility (IRF)|ORR was the percentage of participants whose confirmed best overall response was either a Partial Response (PR) or a Complete Response (CR) based upon the IRF assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm); PR:greater than (>) or equal to (=) 30 percent (%) decrease from baseline in sum of diameters of target lesions, non-progressive disease (PD) non-target lesions and no new lesions. Results were reported by line of therapy and programmed death-ligand 1 (PD-L1) Expression Subgroup (tumor cell [TC]3 [TC3] or tumor-infiltrating immune cell [IC] 3 [IC3], TC3 or IC2/3, TC2/3 or IC2/3).|Screening, Every 6 weeks (± 3 days) for 12 months following Cycle 1, Day 1 and every 9 weeks (± 1 week) thereafter until disease progression, intolerable toxicity or death until data cut-off on 28 May 2015 (Up to 16 months)|Efficacy evaluable population; Number (n) equals (=) number of participants analyzed within the specified group.|||percentage of participants||95% Confidence Interval|Number
2612628|NCT02031432|Other Pre-specified|Mean Eastern Cooperative Oncology Group Performance Status (ECOG) Scores|"The investigator scores the ECOG performance status for a participant on a 6-point categorical scale as follows:~0 indicates that a participant is fully active, able to carry on all pre-disease performance without restriction.~1 indicates that a participant is restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.~2 indicates that a participant is ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.~3 indicates that a participant is capable of only limited selfcare, confined to bed or chair more than 50% of waking hours.~4 indicates that a participant is completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.~5 indicates that a participant is dead. Mean ECOG performance status scores are calculated for the number of participants with data available."|From Baseline (Day 1) through to End of treatment (up to Week 26) (9 time points)|Safety Set; number of participants with data available at the respective visit|||units on a scale||Standard Deviation|Mean
2612629|NCT02031432|Other Pre-specified|Mean Equipotency Ratio of Morphine Sulfate Prolonged Release Compared to Cebranopadol.|For those participants, who received morphine prolonged release in the CORAL trial (KF6005/07, NCT01964378) and were, thus, switched from morphine prolonged release to cebranopadol in the CORAL XT trial, the equianalgesic doses of morphine prolonged release and cebranopadol was identified.|Baseline (Day 1); End of first month of treatment|Safety Set; the Conversion Ratio of Morphine Prolonged Release to Cebranopadol was available for 32 of 76 participants.|||Ratio||Standard Deviation|Mean
2612630|NCT02031432|Other Pre-specified|Use of On-demand Opioid Analgesic Medication|Participants reported the opioid type and amount of an opioid in mg/day used to relieve their breakthrough pain over the time period in the study. The average number of units of on-demand opioid medication administered during the previous day (reported on Day 3) and during the last 3 days (reported at all other visits) were documented. The number of units of on-demand opioid medication administered during the Treatment Period is summarized descriptively over the treatment period.|From Day 3 to End of Treatment (up to Week 26) (13 time points)|Safety Set; participants with data available at the respective visit.|||units||Standard Deviation|Mean
2612631|NCT02031432|Other Pre-specified|Clinical Global Impression of Change (CGIC)|"For the CGIC assessment, the clinician indicates the perceived change in the patient's condition over the treatment period as compared to the patient's condition prior to the start of treatment. The clinician is requested to choose 1 of 7 categories. Categories range from very much improved to very much worse."|Baseline (Day 1); End of Treatment Visit (up to Week 26)|Safety Set; 62 participants completed the End of Treatment Visit.|||Participants|||Count of Participants
2612632|NCT02031432|Other Pre-specified|Patient Global Impression of Change (PGIC)|"In the PGIC, participants indicates the perceived change over the treatment period compared to their condition prior to the start of treatment. Participants are requested to choose 1 of 7 categories. Scores range from very much improved to very much worse. The frequency of responses per category are provided."|Baseline (Day 1); End of Treatment (up to Week 26)|Safety Set; 62 participants completed the End of Treatment Visit.|||Participants|||Count of Participants
2612633|NCT02031432|Other Pre-specified|EuroQol-5 Dimension (EQ-5D) Health Questionnaire - Visual Analog Scale (VAS)|"The EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant-rated scale where a single value is ticked for Your own health state today on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state."|Baseline (Day 1); End of Treatment (up to Week 26)|Safety Set; participants with data available at respective time point.|||units on a scale||Standard Deviation|Mean
2612634|NCT02031432|Other Pre-specified|EuroQol-5 Dimension (EQ-5D) Health Status Index Outcome|"Participants answered 5 questions on the 5 dimensions of the EuroQol-5 Dimension Health Questionnaire: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question has 3 possible answers reflecting 3 levels of impact on the quality of life. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D Health Status Index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1), the better the health status."|Baseline (Day 1); End of Treatment (up to Week 26)|Safety Set; participants with data available at respective time point.|||units on a scale||Standard Deviation|Mean
2612635|NCT02031432|Other Pre-specified|Mean Scores of Neuropathic Pain Symptom Inventory (NPSI)|"Participants with neuropathic pain (determined by the completion of the DN4 [Douleur Neuropathique] questionnaire at enrollment) rated their symptoms of neuropathic pain using the NPSI. Ten out of 12 questions (Q1-3, 5, 6, 8-12) are answered on an 11-point numerical scale (NRS) ranging from 0 (no symptom present) to 10 (worst imaginable).~The NPSI Total Score was calculated as the sum of the 10 single items scored on the 11-point NRS divided by 100. The mean score is reported on a scale of 0 (no neuropathic pain components present) to 1 (all neuropathic pain components have the maximum imaginable intensity)."|Baseline (Day 1); Weeks 2, 6, 14, 18; End of Treatment (up to Week 26)|Safety Set (21 participants with neuropathic pain of 76 participants enrolled)|||units on a scale||Standard Deviation|Mean
2612839|NCT02028676|Secondary|Cotrimoxazole: Change From Baseline in CD4% to Week 72||Baseline, week 72|All participants alive in follow-up with CD4%|||percentage of total lymphocytes||Standard Deviation|Mean
2612637|NCT02031432|Other Pre-specified|Worst Pain Intensity in the Last Week of Treatment (Week 26)|"Participants were asked: Please rate your pain by selecting the one number that best describes your pain at its worst during the last week. at some of the visits during the treatment period. They scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The mean scores of the worst pain intensity were calculated for all participants. Results for baseline and Week 26 are presented."|Baseline (Day 1); End of Treatment (Week 26)|Safety Set; 59 participants completed End of Treatment Visit|||units on a scale||Standard Deviation|Mean
2612638|NCT02031432|Other Pre-specified|Weekly Means of Daily Average Pain Intensity During the First Month of Treatment|"Participants were asked: Please rate your pain by selecting the one number that best describes your pain on average during the last 24 hours. every day in the morning during the first month of treatment (comprising Titration Weeks 1 and 2 and Maintenance Weeks 1 and 2). They scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The weekly mean value of the 24-hour average pain intensity was calculated as a mean score of these daily entries of average pain intensity for each week."|Baseline (Day 1); Titration Weeks 1 and 2; Maintenance Weeks 1 and 2|Safety Set; data for participants who completed respective visit.|||units on a scale||Standard Deviation|Mean
2612639|NCT02031432|Other Pre-specified|Mean Scores of Chronic Pain Sleep Inventory (CPSI) and Changes From Baseline|"The CPSI was completed by the participants. It measures 5 items, all on a 100-mm visual analog scale:~Participant's assessment of Sleep Problem Index subscores and need for sleep medication (the lower the score the better): (1) Trouble falling asleep (0 = never; 100 = always); (2) Needing sleep medication to help fall asleep (0 = never, 100 = always); (3) Awakened by pain during the night (0 = never, 100 = always); and (4) Awakened by pain in the morning (0 = never, 100 = always). The Sleep Problem Index is the sum of items (1), (3), and (4) with a maximum score of 100 indicating maximum sleep problems.~Participant's assessment of the Overall Quality of Sleep (the higher the score the better): (5) Overall quality of sleep (0 = very poor, 100 = excellent)."|Baseline (Day 1); End of Treatment (up to Week 26)|Safety Set; participants with data available at respective time point.|||units on a scale||Standard Deviation|Mean
2612640|NCT02031432|Other Pre-specified|Columbia-Suicide Severity Rating Scale (C-SSRS) Scores|The C-SSRS was administered by a clinician who had been certified to administer the C-SSRS at each visit. Suicidal ideation is classified on a 5-item scale (where 1 = Wish to be dead, 2 = Non-specific active suicidal thoughts, 3 = Active Suicidal Ideation with any methods (not plan) without intent to act, 4 = Active Suicidal Ideation with some intent to act, without specific plan, 5 = Active suicidal ideation with a specific plan and intent). The number of participants with suicidal ideation at baseline is presented below for categories with at least 1 participant.|Baseline (Day 1) to End of trial (up to Week 28)|Safety Set|||Participants|||Count of Participants
2612641|NCT02031432|Other Pre-specified|Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Cebranopadol|Only participants with TEAEs which were assessed by the investigator as falling into one of the 3 categories of causality (Possible, Probable/likely, or Certain) were summarized. The initial breakdown planned based on intensity, outcome, time to onset, duration, and countermeasures was not performed and is therefore not reported.|Baseline (Day 2) to End of trial (up to Week 28)|Safety Set|||Participants|||Count of Participants
2612642|NCT02031432|Other Pre-specified|Countermeasures Taken for Treatment Emergent Adverse Events (TEAEs)|"The countermeasure of a Treatment Emergent Adverse Event (TEAE) was classified by the investigator as being a study medication-related countermeasure and based on non-study medication countermeasures.~Non-study medication related countermeasures were categorized as being one of the following: No countermeasure given; A newly started medication or change in dose or route of application of a concomitant medication due to the AE; Other countermeasures, e.g., physical therapy, surgery.~Study medication-related countermeasures were categorized as being one of the following: Dose not changed; Dose reduced; Drug interrupted; Trial discontinuation.~Absolute numbers are per category reported."|Baseline (Day 2) to End of trial (up to Week 28)|Safety Set; event-based analysis.|||Number of TEAEs|Number of TEAEs||Number
2612643|NCT02031432|Other Pre-specified|Causal Relationship of Treatment Emergent Adverse Events (TEAEs)|The causality of TEAEs was assessed by the investigator as falling into 1 of the following 7 categories: Conditional/Unclassified, Unassessable/Unclassifiable, Not related, Unlikely, Possible, Probable/likely, or Certain. The numbers of TEAEs per category are presented.|Baseline (Day 2) to End of trial (up to Week 28)|Safety Set; event-based analysis on 661 TEAEs|||Number of TEAEs|Number of TEAEs||Number
2612644|NCT02031432|Other Pre-specified|Duration of Treatment Emergent Adverse Events (TEAEs)|An adverse event is any untoward medical occurrence attributed to cebranopadol. Duration of Adverse Event was calculated as stop date minus start date plus 1 for non-missing and partial dates.|Baseline (Day 2) to End of trial (up to Week 28)|Safety Set; data available for 373 TEAEs (duration data for 288 of 661 TEAEs were not available)|||days|Number of TEAEs|Inter-Quartile Range|Median
2612645|NCT02031432|Other Pre-specified|Time to Onset of Treatment Emergent Adverse Events (TEAEs)|The median time, in days, from the start of the open-label cebranopadol treatment to the start day of the treatment emergent adverse event (TEAE).|Baseline (Day 2) to End of trial (up to Week 28)|Safety Set; event-based analysis for 661 TEAEs.|||days|Number of TEAEs|Inter-Quartile Range|Median
2612646|NCT02031432|Other Pre-specified|Outcome of Treatment Emergent Adverse Events (TEAE)|"The outcome of a TEAE was classified into 1 of the following 6 categories by the investigator, i.e.~Recovered/Resolved.~Recovered/Resolved with sequelae.~Fatal~Recovering/Resolving.~Not recovered/Not resolved.~Unknown (e.g., because the participant is lost to follow up)."|Baseline (Day 2) to End of trial (i.e., up to Week 28)|Safety Set; event-based analysis|||Number of TEAEs|Number of TEAEs||Number
2612647|NCT02031432|Secondary|Changes From Baseline in the Average Pain Intensity in the Last Week During the Treatment Period|"Participants were asked Please rate your pain by selecting the one number that best describes your pain on average during the last week. and scored their average pain intensity during the last week of the treatment period on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The absolute change from baseline for the average pain intensity during the last week was determined for all participants that scored their pain intensities. A mean value for all participants was calculated."|Baseline Visit (Day 1) to End of Treatment Visit (up to 26 weeks).|Safety Set - participants with data available|||units on a scale||Standard Deviation|Mean
2612648|NCT02031432|Secondary|Intensity of Treatment Emergent Adverse Events|"A Treatment Emergent Adverse Event (TEAE) was defined as any Adverse Event (AE) that occurred on or after the first intake of cebranopadol or a pretreatment AE which worsened during the treatment period. TEAEs were classified by the investigator as falling into 1 of 3 categories:~Mild: Signs and symptoms that can be easily tolerated. Symptoms can be ignored and disappear when the participant is distracted.~Moderate: Symptoms cause discomfort but are tolerable; they cannot be ignored and affect concentration.~Severe: Symptoms which affect usual daily activity.~For TEAE where the intensity changed over time, the maximum intensity observed during the whole duration of the adverse event was documented."|Up to 28 weeks (26 weeks of cebranopadol treatment and 2 weeks follow-up after the last dose)|Safety Set; event-based analysis|||Number of TEAEs|Number of TEAEs||Number
2612649|NCT02031432|Primary|Number of Participants With Treatment Emergent Adverse Event (TEAEs)|The safety of cebranopadol was assessed by the number of participants with treatment emergent adverse events (TEAEs). A TEAE was any adverse event that occurred after the first administration of investigational medicinal product (IMP), i.e., cebranopadol in this study. In addition, pretreatment adverse events which worsened during the treatment period were also considered TEAEs.|Up to 28 weeks (26 weeks of cebranopadol treatment and 2 weeks follow up after the last dose)|Safety Set|||Participants|||Count of Participants
2612650|NCT02031302|Secondary|Patients With Moderate and Severe Paravalvular Aortic Valve Regurgitation|"Grade of paravalvular aortic valve regurgitation pre-discharge as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory. The moderate and severe paravalvular aortic regurgitation rate will be compared to a pre-specified performance goal.~We don't have a powered analysis for the PVL for RESPOND study."|Duration of hospital stay, an expected average of 2 days|62 patients had no data available for the analysis in the Lotus Valve arm. 13 patients had no data for the analysis in the Lotus with Depth Guard arm.|||Participants|||Count of Participants
2612651|NCT02031302|Secondary|Patients With VARC Safety Composite Outcomes at 30 Days|"Patients with VARC safety composite outcomes at 30 days. VARC safety composite endpoints are defined as:~Life-threatening bleeding~Acute kidney injury—Stage 2 or 3 (including renal replacement therapy)~Coronary artery obstruction requiring intervention~Major vascular complication~Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)~New conduction disturbances (LBBB, AVB, RBBB) and need for permanent pacemaker implantation"|30 Days|The analysis of patients with valve safety composite outcomes at 30 days based on the as treated population for the Lotus valve arm (996) through 30 days. In the Lotus with Depth Guard arm are all patients treated with the device.|||Participants|||Count of Participants
2612652|NCT02031302|Secondary|Patients With Valve Safety Composite Outcomes at 1 Year|"Time related valve safety composite outcomes at 1 year, including structural valve deterioration (valve-related dysfunction requiring repeat procedure [TAVI or SAVR]); prosthetic valve endocarditis; prosthetic valve thrombosis; thromboembolic events (e.g. stroke) and VARC bleeding, unless clearly unrelated to valve therapy based on investigator assessment (e.g. trauma).~The Lotus Valve cohort is an ongoing study in it's 4 year follow up. The Lotus with Depth Guard cohort ended after 30 day follow up, therefore we have no data at 1 year."|1 Year|The analysis of patients with valve safety composite outcomes at 1 year is based on the as treated population for the Lotus valve arm (996) through 1 year; 8 subjects out of 996 subjects are excluded from the analysis because they don't have sufficient follow up; their last follow up days are less than 320 days.|||Participants|||Count of Participants
2612653|NCT02031302|Secondary|Percentage of Participants With Events Included in the VARC Efficacy Composite Endpoint|The VARC efficacy composite at 1 year, including all-cause mortality; all stroke (disabling and non-disabling); re-hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV); and prosthetic valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, effective orifice area (EOA) ≤0.9-1.1 cm2 and/or Doppler velocity index (DVI) <0.35 m/s, AND/OR moderate or severe prosthetic valve aortic regurgitation)|1 Year|The Lotus Valve cohort is an ongoing study in it's 4 year follow up. The Lotus with Depth Guard cohort ended after 30 day follow up, therefore we have no data at 1 year. 443 patients had no Echo analysis and therefore no data available.|||Participants|||Count of Participants
2612654|NCT02031302|Secondary|In-hospital Mortality|In-hospital mortality till discharge|Duration of hospital stay, an expected average of 2 days|The In-hospital till discharge analysis is based on the as treated population for the Lotus valve arm (996). In the Lotus with Depth Guard arm are all patients treated with the device.|||Participants|||Count of Participants
2612655|NCT02031302|Secondary|Percentage of Participants With Events Included in the Safety Composite Endpoint of All-Cause Mortality and Disabling Stroke|All subjects who are candidates for transcatheter aortic valve implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve will be evaluated for enrollment in this study (as treated population) The Lotus Valve cohort is an ongoing study in it's 4 year follow up. The Lotus with Depth Guard cohort ended after 30 day follow up, therefore we have no data at 1 year.|30 Days and 1 year|The Safety composite of all-cause mortality and disabling stroke analysis is based on the as treated population for the Lotus valve arm (996) through 1 year; 8 subjects out of 996 subjects are excluded from the analysis because they don't have sufficient follow up; their last follow up days are less than 320 days.|||Participants|||Count of Participants
2612656|NCT02031302|Primary|All-cause Mortality|"The primary endpoint is all-cause mortality at 1 year after the implant procedure. The primary safety endpoint will be evaluated on an intention-to-treat (ITT) basis (all subjects enrolled, whether or not a Lotus Valve is implanted).~A total of 116 subjects died through 1 year (365 days) post procedure (as treated population). 4 additional patients died but were not treated with the study valve system (ITT population).~The Lotus Valve cohort is an ongoing study in it's 4 year follow up. The Lotus with Depth Guard cohort ended after 30 day follow up, therefore we have no data at 1 year."|1 Year|The primary endpoint analysis is based on the ITT population (1014) through 1 year; 12 subjects out of 1014 subjects are excluded from the analysis because they don't have sufficient follow up, their last follow up days are less than 320 days.|||Participants|||Count of Participants
2612696|NCT02030535|Secondary|Mean RR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Mean RR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
2612657|NCT02031302|Primary|All-cause Mortality|The primary endpoint is all-cause mortality at 30 days after the implant procedure. The primary safety endpoint will be evaluated on an intention-to-treat (ITT) basis (all subjects enrolled, whether or not a Lotus Valve is implanted). All-cause mortality at 30 days after the implant procedure will be compared to a pre-specified performance goal.|30 Days|The primary endpoint analysis is based on the ITT population (1014) through 30 days; 9 subjects out of 1014 subjects are excluded from the analysis because they don't have sufficient follow up, their last follow up days are less than 23 days.|||Participants|||Count of Participants
2612658|NCT02031276|Secondary|Percentage of Participants Achieving Deep Remission at Week 12|Deep remission is defined as clinical remission (CDAI < 150) AND CDEIS remission (CDEIS ≤ 4, or ≤ 2 in participants with initial isolated ileitis) at Week 12. NRI: missing values were counted as nonresponders.|Week 12|FAS-P1: All randomized subjects who received at least 1 dose of study drug in the double-blind IV period (Period 1).|||percentage of participants||95% Confidence Interval|Number
2612659|NCT02031276|Secondary|Percentage of Participants Achieving Mucosal Healing at Week 12|Mucosal healing was defined as the absence of mucosal ulceration, i.e., a CDEIS ulceration sub-score (deep ulceration, superficial ulceration, ulcerated stenosis) of 0 at Week 12. NRI: missing values were counted as nonresponders.|Week 12|FAS-P1: All randomized subjects who received at least 1 dose of study drug in the double-blind IV period (Period 1).|||percentage of participants||95% Confidence Interval|Number
2612660|NCT02031276|Secondary|Percentage of Participants Achieving CDEIS Response at Week 12|CDEIS is an index for determining the severity of Crohn's disease with endoscopic localization to ileum and colon. CDEIS considers 4 parameters (deep ulcerations, superficial ulcerations, surface involved by disease, and surface involved by ulcerations), each one evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The results of the individual segments of the colon are divided by the number of segments investigated; the presence of stenosis increases the score at the end of the computation. CDEIS response is defined as defined as ≥ 50% reduction of CDEIS from Baseline to Week 12. NRI: missing values were counted as nonresponders.|Week 12|FAS-P1: All randomized subjects who received at least 1 dose of study drug in the double-blind IV period (Period 1).|||percentage of participants||95% Confidence Interval|Number
2612661|NCT02031276|Secondary|Percentage of Participants Achieving Crohn's Disease Endoscopic Index of Severity (CDEIS) Remission at Week 12|CDEIS is an index for determining the severity of Crohn's disease with endoscopic localization to ileum and colon. CDEIS considers 4 parameters (deep ulcerations, superficial ulcerations, surface involved by disease, and surface involved by ulcerations), each one evaluated in 5 pre-defined segments of the colon (ileum, ascending colon, transverse colon, descending colon and sigmoid loop, and rectum). The results of the individual segments of the colon are divided by the number of segments investigated; the presence of stenosis increases the score at the end of the computation. CDEIS remission is defined as a CDEIS ≤ 4 (or, for patients with initial isolated ileitis, a CDEIS ≤ 2) at Week 12. NRI: missing values were counted as nonresponders.|Week 12|FAS-P1: All randomized subjects who received at least 1 dose of study drug in the double-blind IV period (Period 1).|||percentage of participants||95% Confidence Interval|Number
2612662|NCT02031276|Secondary|Percentage of Participants Achieving CDAI Clinical Response at Week 12|The CDAI is a measure of clinical response and remission. The CDAI includes 8 variables encompassing both patient-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI. Higher CDAI scores indicate greater disease activity, with a lower limit of 0 and no set upper limit: < 150 indicates remission, 150 - 219 indicates mildly active disease, 220 - 450 indicates moderately active disease, and > 450 indicates severely active disease. CDAI clinical response is defined as either a CDAI < 150 or a CDAI reduction from Baseline of at least 100 points at Week 12. NRI: missing values were counted as nonresponders.|Week 12|FAS-P1: All randomized subjects who received at least 1 dose of study drug in the double-blind IV period (Period 1).|||percentage of participants||95% Confidence Interval|Number
2612663|NCT02031276|Primary|Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Clinical Remission at Week 12|The CDAI is a measure of clinical response and remission. The CDAI includes 8 variables encompassing both patient-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, patients keep track of daily symptoms on a diary card and the daily symptom scores are summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI. Higher CDAI scores indicate greater disease activity, with a lower limit of 0 and no set upper limit: < 150 indicates remission, 150 - 219 indicates mildly active disease, 220 - 450 indicates moderately active disease, and > 450 indicates severely active disease. CDAI clinical remission is defined as CDAI < 150 at Week 12. Nonresponder imputation (NRI): missing values were counted as nonresponders.|Week 12|Full Analysis Set-Period 1 (FAS-P1): All randomized subjects who received at least 1 dose of study drug in the double-blind IV period (Period 1).|||percentage of participants||95% Confidence Interval|Number
2612664|NCT02031237|Secondary|Change in Mean K^Trans During and After Radiation Therapy|Effect of radiation dose on vascular permeability (per minute) of the Blood Tumor Barrier (BTB)/Blood Brain Barrier (BBB). Permeability of BTB was quantified by Ktrans.|Pre-treatment and 1 Month Post Treatment|||||||
2612665|NCT02031237|Primary|Change in Magnitude and Regional Variability of Blood Tumor Barrier (BTB)/Blood Brain Barrier (BBB) Permeability (Per Minute) in Tumor, Tumor Margin, Normal Brain and Brain Metastases|An in-house program, based on a general kinetic model, along with an MRI contrast agent, Gadopentetic Acid (Gd-DTPA), will be used to estimate vascular permeability (per minute).|Week -2 to -1, End of Treatment (WBRT), 1-2 Weeks Post Treatment (SRS), 1 Month Post Treatment|||||||
2612697|NCT02030535|Secondary|Heart Rate Change From Patient Baseline at Individual Post-dose Time Points|Heart rate change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||bpm||Standard Deviation|Mean
2613768|NCT02016716|Secondary|Percent Change From Baseline in Serum C-Telopeptide (CTX)||Baseline, month 1, month 3, and month 6|All randomized participants who had a baseline and at least one postbaseline measurement for CTX and with available data at each time point.|||percent change||Inter-Quartile Range|Median
2612666|NCT02031237|Primary|Percentage of the Gross Tumor Volume With a BTB Opening of Ktrans > 0.005 Min-1|Fifty metastatic lesions from 21 patients received WBRT and 14 lesions from 9 patients treated by SRS were analyzed. Permeability of BTB (Blood-Tumor-Barrier) was quantified by the transfer constant, Ktrans, derived from dynamic contrast enhanced (DCE)-MRI that were acquired pre, 1-2 weeks after starting, and 1-month post-radiotherapy. A percentage volume of the BM with Ktrans >0.005 min-1 (%Vall) was used to evaluate the extent of BTB opening pre-RT and subsequent changes after receiving radiotherapy. The 50 lesions, from the 21 patients treated with Whole Brain Radiation Therapy, were divided into two subgroups: low-leaky (%Vall <50%) and high-leaky, based upon pre-RT measurements. Of the 50 lesions, 7 were classified as low leaky and 43 were classified as high leaky. All 14 SRS lesions were classified as high leaky.|Pre-Treatment, 1-2 Weeks Post Treatment (SRS), 1 Month Post Treatment|Fifty metastatic lesions from 21 patients received WBRT and 14 lesions from 9 patients treated by SRS were analyzed. All lesions were classified as high or low leaky dependent upon pre-RT permeability values.|||percentage of gross tumor volume|lesions|Standard Error|Mean
2612667|NCT02030847|Secondary|Best Overall Response|For the secondary efficacy objectives for this study, the number of patients were computed with a best overall disease response of CR or CRi, where the best overall disease response is defined as the best disease response recorded from the start of the treatment until death, last follow up, relapse or start of new anticancer therapy, whichever comes first.|from the start of the treatment until death, last follow up, relapse or start of new anticancer therapy, whichever comes first, assessed up to 12 months|Out of 42 enrolled, only 30 patients were infused with CART-19 product. 30 infused patients were considered for outcome measure.|||Participants|||Count of Participants
2612668|NCT02030847|Primary|Overall Complete Remission Rate at Day 28 After CART-19 Therapy|"Overall Complete Remission Rate (ORR) which includes complete remission (CR) and CR with incomplete blood count recovery (CRi) at Day 28.~Overall Complete Remission Rate = CR+ CRi"|28 Days|Out of 42 enrolled, only 30 patients were infused with CART-19 product. 30 infused patients were considered for outcome measure.|||Participants|||Count of Participants
2612669|NCT02030821|Secondary|Cost of Hospitalization||Participants will be followed for the duration of hospital stay, an expected average of 5 days|Data not collected.||||||
2612670|NCT02030821|Secondary|Length of Hospitalization Stay||Participants will be followed for the duration of hospital stay, an expected average of 5 days||||days||Inter-Quartile Range|Median
2612671|NCT02030821|Primary|Difference in Preoperative and Lowest Postoperative Hemoglobin||Participants will be followed for the duration of hospital stay, an expected average of 5 days||||grams per deciliter||Inter-Quartile Range|Median
2612672|NCT02030821|Primary|Number of Transfusions||Participants will be followed for the duration of hospital stay, an expected average of 5 days||||transfusions|||Number
2612673|NCT02030821|Primary|Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge)||Participants will be followed for the duration of hospital stay, an expected average of 5 days||||milliliters||Inter-Quartile Range|Median
2612674|NCT02030600|Secondary|FPG (Fasting Plasma Glucose)|Fasting plasma glucose values at week 32 and week 64.|week 32, week 64|Full analysis set. Here, 'n' specifies the number of subjects with available data at specified timepoint.|||mg/dL||Standard Deviation|Mean
2612675|NCT02030600|Secondary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c (glycosylated haemoglobin) at week 32 (treatment period 1) and at week 64 (treatment period 2). Week 32 HbA1c value was considered as baseline for calculating change from baseline in HbA1c at week 64.|Week 32, Week 64|Full analysis set. Here, 'n' specifies the number of subjects with available data at specified timepoint.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2612676|NCT02030600|Secondary|Incidence of Treatment Emergent Adverse Events|Treatment emergent adverse event was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|During 32 weeks of treatment for each treatment period|Safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator (Total number of subjects analysed for this endpoint: 713).|||events|||Number
2612677|NCT02030600|Secondary|Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period|Percentage of subjects who experienced one or more severe hypoglycaemic episodes during the maintenance period. Severe hypoglycaemia (according to the American Diabetes Association 2013 definition): A hypoglycaemic episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose values may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.|After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|The trial followed a cross over design. Descriptive analysis was based on the safety analysis set. Number of subjects analysed=subjects with available data for the endpoint as per individual trial products. Statistical analysis was performed on subjects in full analysis set with exposure in both maintenance periods.|||percentage of subjects|||Number
2612678|NCT02030600|Secondary|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episode During the Maintenance Period|Severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia and with time of onset between 00:01 and 05.59 a.m., both inclusive. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|The trial followed a cross over design. Descriptive analysis was based on the safety analysis set (subjects receiving at least one dose of the investigational product or its comparator). Number of subjects analysed=subjects with available data for the endpoint as per individual trial products. Statistical analysis was performed on full analysis set|||events|||Number
2612737|NCT02029638|Secondary|Number of Days From Transplant to Platelet Count Recovery|Time (in days) from transplant to the first day of a platelet count of ≥20,000 per μL without a prior platelet transfusion in the preceding seven days. Low platelet numbers is associated with increased risk of bleeding and bruising. A healthy person has a platelet count ranging from 150,000 to 450,000 platelets per microliter of blood.|Transplant to Platelet Count Recovery|Transplanted Per Protocol Participants|||Days||Standard Deviation|Mean
2612679|NCT02030600|Primary|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period|Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)|The trial followed a cross over design. Descriptive analysis was based on the safety analysis set (subjects receiving at least one dose of the investigational product or its comparator). Number of subjects analysed=subjects with available data for the endpoint as per individual trial products. Statistical analysis was performed on full analysis set|||events|||Number
2612680|NCT02030574|Secondary|Number of Participants Experiencing Toxicities With Neoadjuvant Gemcitabine and Fractionated Cisplatin for Patients With Bladder Cancer|Toxicities assessed while patients are on treatments|Prior to each of the 4 cycles of treatment, after 4 months of treatment, 30 days post the last dose of drug (for a total of approximately 5 months)||||participants|||Number
2612681|NCT02030574|Primary|Pathologic Complete Response Rate of Neoadjuvant Gemcitabine and Fractionated Cisplatin for Patients With Muscle Invasive Bladder Cancer Whom Are Not Candidates for High Dose Cisplatin.|Response will be evaluated in this study using the international criteria proposed in the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 [Eur J Cancer. 2009;45:228-247.].Complete Response (CR): Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficie|at approximately 6 months||||participants|||Number
2612682|NCT02030535|Secondary|QRS Change From Patient Baseline at Individual Post-dose Time Points|QRS change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
2612683|NCT02030535|Secondary|Peak QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Peak QRS change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
2612684|NCT02030535|Secondary|Mean QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Mean QRS change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
2612685|NCT02030535|Secondary|PR Change From Patient Baseline at Individual Post-dose Time Points|PR change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
2612686|NCT02030535|Secondary|Peak PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Peak PR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
2612687|NCT02030535|Secondary|Mean PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Mean PR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
2612688|NCT02030535|Secondary|QTcB Change From Patient Baseline at Individual Post-dose Time Points|QTcB change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
2612689|NCT02030535|Secondary|Peak QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points|Peak QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment))change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
2612690|NCT02030535|Secondary|Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points|Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment))change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
2612691|NCT02030535|Secondary|QT Change From Patient Baseline at Individual Post-dose Time Points|QT change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
2612692|NCT02030535|Secondary|Peak QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Peak QT change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
2612693|NCT02030535|Secondary|Mean QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points|Mean QT change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
2612694|NCT02030535|Secondary|RR Change From Patient Baseline at Individual Post-dose Time Points|RR change from patient baseline at individual post-dose time points|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
2612695|NCT02030535|Secondary|Peak RR Change From Patient Baseline Over All Post-dose Time Points|Peak RR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
2612698|NCT02030535|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3hours) Response After Single-dose Administration|"The response was defined as the change from patient baseline. Patient baseline was the average of the mean pre-dose values (period baseline) on each test day (Visit 2 (Day 1), Visit 3 (Day 22 (±7days)), and Visit 4 (Day 43±7days)).~For patients who did not complete all periods, patient baseline was the average of the available period baselines.~The means presented are the adjusted means."|1 hour (h) and 10 min pre-dose and at 15 min, 30 min, 1 h, 2 h and 3 h post-dose|Full Analysis Set (FAS): This patient set included all patients in the TS who had at least 1 visit (Visit 2(Day1), Visit 3(Day22), or Visit 4(Day43)) with both the period baseline value plus any evaluable post-dose spirometry measurement from the same visit.|||Litres||Standard Error|Mean
2612699|NCT02030535|Secondary|Peak Heart Rate Change From Patient Baseline Over All Post-dose Time Points|Peak heart rate change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||bpm||Standard Deviation|Mean
2612700|NCT02030535|Secondary|Mean Heart Rate Change From Patient Baseline Over All Post-dose Time Points|Mean heart rate change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||bpm||Standard Deviation|Mean
2612701|NCT02030535|Secondary|Peak QTcF Interval Change From Patient Baseline Over All Post-dose Time Points|Peak QTcF interval change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
2612702|NCT02030535|Secondary|Mean (Heart Rate Corrected QT Interval (Using Fredericia Adjustment)) QTcF Interval Change From Patient Baseline Over All Post-dose Time Points|Mean QTcF interval change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)|40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose|Treated set (observed cases)|||ms||Standard Deviation|Mean
2612703|NCT02030405|Secondary|Serious Adverse Events Related to Ixazomib|"Ixazomib toxicity and tolerability were assessed based on the non-hematologic toxicities ≥ Grade 3 determined to be possibly, probably, or definitely related to the study agent Ixazomib.~Adverse events that are possibly, probably, or definitely related to the study agent are considered toxicities. The outcome is reported as the overall number of non-hematologic toxicities ≥ Grade 3."|1 year|All treated subjects are included.|||Related adverse events|||Number
2612704|NCT02030405|Secondary|Overall Survival (OS)|Overall survival (OS) from time of study entry to the earlier of death from any cause or end of follow up at 1 year|1 year||||Participants|||Count of Participants
2612705|NCT02030405|Secondary|Duration of Response (DOR)|Duration of response (DOR) in participants with complete remission (CR) was defined as the period of time from documented complete remission through relapse or death, with relapse defined as reappearance of blasts in the blood or bone marrow blasts, after documented CR. DOR was to be assessed through at least 1 year follow-up.|1 year|No participants met the criteria of complete remission (CR), and so duration of response (DOR) in those participants could not be assessed.||||||
2612706|NCT02030405|Primary|Overall Response Rate (ORR)|"Overall response rate after 3 cycles of treatment (9 weeks) was assessed as complete remission (CR); CR with incomplete recovery (CRi); and partial remission (PR) with MLN9708, in participants with NPM1-mutated AML by LeukemiaNet1 guidelines:~Although achievement of complete remission (CR) has unique clinical significance for improved overall survival (OS) and relapse-free survival (RFS) compared to achievement of CRi with incomplete platelet recovery, the latter is still a clinically meaningful response, as it is independently-superior to resistant disease.~Partial remission (PR) is defined as meeting all hematologic criteria for CR with an allowance for 5% to 25% bone marrow blasts or decrease of pre-treatment bone marrow blast percentage by at least 50%.~Stable disease is defined as a change in bone marrow aspirate blast count within 10% of baseline.~Relapsed disease is defined as reappearance of blasts in the blood or bone marrow blasts"|9 weeks||||Participants|||Count of Participants
2612707|NCT02030119|Secondary|Average Number of Steps Per Day|Secondary outcomes include average number of steps each individual takes per day throughout the 13-week intervention and additional 13-week follow-up periods.|Throughout the 6 month study||||Steps per day||95% Confidence Interval|Mean
2612708|NCT02030119|Primary|Proportion of Days Each Individual Walks 7000 Steps Per Day or More|The primary outcome measure is the mean proportion of participant-days a minimum activity of 7000 steps or more is achieved. Outcomes will be assessed each week for 3 months using incentives followed by 3 months of follow-up without incentives.|Throughout the 6 month study||||Proportion of participant-days||95% Confidence Interval|Mean
2612709|NCT02030080|Secondary|Average Number of Steps Per Day|Secondary outcomes include average number of steps per day during the incentive period (first 3 months) and follow-up period (second 3 months).|Throughout the 6-month study||||Mean daily step counts||95% Confidence Interval|Mean
2612710|NCT02030080|Primary|Proportion of Days a Participant Walks 7000 Steps or More|The primary outcome measure is the proportion of days a minimum activity of 7000 steps or more is achieved. Outcomes will be assessed each week for 3 months using incentives followed by 3 months of follow-up without incentives. Below we report the highest mean proportions found.|Throughout 6-month study||||Mean proportion||95% Confidence Interval|Mean
2612711|NCT02030041|Primary|Skeletal Muscle Mitochondrial Content|Skeletal muscle citrate synthase activity is a validated marker of mitochondrial content. Skeletal muscle biopsy was obtained from vastus lateralis muscle of five patients in either groups before and after the intervention. Under aseptic conditions, samples were taken in protease inhibitor cocktail and stored at -80ºC. Mitochondrial citrate synthase activity (the working range of the kit was 1.56-100 µg/mL, with intra and inter assay CV of 4.35-6.55 % and 8.3 % respectively) was measured using ELISA Kit (Abcam, Cambridge, UK) as per manufacturer's instructions.Skeletal muscle citrate synthase activity is a validated marker of mitochondrial content.|Twelve weeks||||change in mOD/min at 412nm||Standard Deviation|Mean
2612779|NCT02029521|Primary|Fecal Calprotectin|Fecal Calprotectin, a measure of gut inflammation, was measured to see if the treatment decreased this outcome.|6 months|All participants.|||Micrograms/gram feces||Standard Deviation|Mean
2612780|NCT02029521|Primary|Height Percentile|The subjects were measured over the course of the study to determine if treatment improved height percentile.|6 Months|All participants.|||Percentile adjusted for age and sex||Standard Deviation|Mean
2612712|NCT02030041|Primary|Peak Oxygen Consumption|Peak oxygen consumption( VO2peak) is defined as the highest rate at which oxygen can be taken up and utilized by the body during severe exercise. The participants were encouraged to exercise to exhaustion with progressive 2-minutes increments in the power output during the test. VO2peak was obtained when participants reached volitional exhaustion and met at least one of the following criteria: plateau in oxygen consumption despite increase in workload, rating of perceived exertion >18, Respiratory exchange ratio > 1.10 and peak heart rate within 10 beats of age predicted maximum. . As VO2peak (expressed as liters of oxygen consumed per minute) is also dependent on age, sex, and body size, it was expressed as percentage of the predicted value(VO2peak%).|Twelve weeks||||percentage of predicted value||Standard Deviation|Mean
2612713|NCT02029989|Primary|Metabolic Syndrome (MetS)|compare test results in subjects between the PCS and NCS groups, with or without pre-existing MetS and/or related metabolic conditions at baseline|Baseline||||percentage of participants|||Number
2612714|NCT02029911|Post-Hoc|Subjects With Amenorrhea at 12 Months|Amenorrhea at 12 Months- Number of subjects experiencing no menstrual bleeding|12 Months|Protocol Intent-to-treat|||participants|||Number
2612715|NCT02029911|Secondary|Procedure Time|Procedure Time defined as time from insertion of the Disposable Handpiece to the time of removal.|< 1 hour|Subjects completing treatment|||Minutes||Standard Deviation|Mean
2612716|NCT02029911|Primary|Reduction in Menstrual Blood Loss to Normal Levels at 12 Months|Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of <=75.|12 Months|Protocol Intent-to-treat populations (all subjects in whom the experimental device was attempted to be placed)|||participants|||Number
2612717|NCT02029872|Primary|Number of Participants With Recurrent Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization|Participants were decolonized with a standard Methicillin-resistant Staphylococcus aureus (MRSA) decolonization protocol and monitored for 6 months. This is the number of participants who screened positive for Methicillin-resistant Staphylococcus aureus (MRSA) 6 months after being decolonized (i.e., recurrent infection)|6 months|"Only participants who received the decolonization protocol and completed the 6 month follow-up visit (7 for individual alone' and 6 for 'Individual plus household') were included in the analysis. The rest were lost to follow up"|||Participants|||Count of Participants
2612718|NCT02029846|Other Pre-specified|Diabetes Quality of Life|Data not analyzed due to n=1 each arm|6 months|Data not analyzed due to n=1 each arm||||||
2612719|NCT02029846|Secondary|Overall Hypoglycemia Measured by Glucose Meter|Data not analyzed due to n=1 each arm.|6 months|Data not analyzed due to n=1 each arm.||||||
2612720|NCT02029846|Primary|Time to Achieve Glycemic Target (HbA1c <7.5%).|Data not analyzed due to n=1 each arm.|6 months|Data not analyzed due to n=1 each arm.||||||
2612721|NCT02029755|Secondary|Number of Participants With Intervention-related Complication|participants will be followed for the duration of hospital stay|an expected average of 5 days|||||||
2612722|NCT02029755|Secondary|Length of Hospital Stay|participants will be followed for the duration of hospital stay|an expected average of 5 days|||||||
2612723|NCT02029755|Secondary|Time to Flatus|participants will be followed for the duration of hospital stay|an expected average of 5 days|||||||
2612724|NCT02029755|Secondary|Heart Rate Variability||preoperative, postoperative 1 hour and 1 day|||||||
2612725|NCT02029755|Secondary|Quality of Recovery 40||postoperative 48 hour|||||||
2612726|NCT02029755|Secondary|Pruritus||postoperative 1, 6, 24, 48 hour|||||||
2612727|NCT02029755|Secondary|Time to the First Request of Analgesics|participants will be followed for the duration of hospital stay|an expected average of 5 days|||||||
2612728|NCT02029755|Secondary|Rescue Antiemetics Use||postoperative 1, 6, 12, 24, 36, 48 hour|||||||
2612729|NCT02029755|Secondary|Rescue Analgesic Use||postoperative 1, 6, 12, 24, 36, 48 hour|||||||
2612730|NCT02029755|Secondary|Nausea and Vomiting Categorical Score||postoperative 1, 6, 24, 48 hour|||||||
2612731|NCT02029755|Secondary|Sedation Scale||postoperative 1, 6, 24, 48 hour|||||||
2612732|NCT02029755|Primary|Opioid Consumption|opioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours).|postoperative 48 hour||||mg||Standard Deviation|Mean
2612733|NCT02029755|Primary|Pain Score (NRS: Numerical Rating Scale)|"pain scores of the participants will be followed at postoperative 1, 6, 24, 48 hour (up to 48 hours).~(NRS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome."|postoperative 24 hour dynamic||||units on a scale||Standard Error|Mean
2612734|NCT02029703|Primary|Difference in Pain Score Between Groups|"The primary objective of this study is the inter-group difference in the KOOS (Knee injury and Osteoarthritis Outcome Score) pain subscale score over 12 and 24 weeks in subjects diagnosed with primary knee OA that are treated with standardized PT and Synvisc-One versus those that are treated with standardized PT and a sham injection.~The scale range is 0-100 with a higher score being better. The pain scale is a subscale of the overall KOOS, and there are no smaller subscales described or used to create this score."|12 and 24 weeks||||units on a scale||Standard Deviation|Mean
2612735|NCT02029638|Secondary|Number of Participants Free From Return to Immunosuppression for the Duration of the Study|Participants who were able to withdrawal successfully from all immunosuppression medication and remained off all immunosuppression medication for the remainder of the study.|Transplant to End of Study (Up to 25 Months)|Transplanted Per Protocol Participants|||Participants|||Count of Participants
2612736|NCT02029638|Secondary|Number of Transplanted Participants Who Remained Off Immunosuppression for at Least 52 Weeks, Including Those in Whom the 52 Week Biopsy Was Not Performed|Number of transplanted participants who remained off immunosuppression for ≥52 weeks, including those in whom the 52 week biopsy was not performed. This outcome included participants who were able to withdrawal successfully from all immunosuppression medication and remain off all immunosuppression for 52 weeks after the completion of withdrawal.|Transplant to 52 Weeks after Discontinuation of All Immunosuppression|Transplanted Per Protocol Participants|||Participants|||Count of Participants
2612781|NCT02029521|Primary|Weight Percentile|Weight percentile, adjusted for sex and age|6 months|All participants.|||Percentile adjusted for age and sex||Standard Deviation|Mean
2612738|NCT02029638|Secondary|Number of Days From Neutrophil Nadir to Absolute Neutrophil Recovery|Time (in days) from neutrophil nadir, the first day post-transplant on which the absolute neutrophil count (ANC) is below 500 per µL, to the first day after three consecutive daily ANCs ≥ 500 per µL. ANC is a measure of the number of neutrophils present in the blood. Neutrophils are a type of white blood cell that fight against infection. A healthy person has an ANC between 2,500 and 6,000 per µL. A value below 500 per µL means the risk of infection is higher.|Post-Transplant Neutrophil Nadir to Neutrophil Recover|Transplanted Per Protocol Participants|||Days||Standard Deviation|Mean
2612739|NCT02029638|Secondary|Number of Transplanted Participants Who Developed Donor-Specific Antibody During Study Participation|Donor-specific antibodies are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection.|Transplant to End of Study (Up to 25 months)|Transplanted Per Protocol Participants|||Participants|||Count of Participants
2612740|NCT02029638|Secondary|Number of Transplanted Participants Who Developed Donor- Specific Antibody After Initiation of Immunosuppression Withdrawal|Donor-specific antibodies are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection.|Initiation of Immunosuppression Withdrawal to End of Study (to 25 months)|Transplanted Per Protocol Participants|||Participants|||Count of Participants
2612741|NCT02029638|Secondary|Duration in Days of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy|AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. Time (in days) from the start date of the AE until the end date of the AE. Two events contributed to this calculation.|First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)|Participants who received any study medication and experienced at least one AE inclusive of infection, wound complications, post-transplant diabetes, hemorrhagic cystitis and/or malignancy.|||Days||Standard Deviation|Mean
2612742|NCT02029638|Secondary|Number of Adverse Events (AEs) by Severity- Including Infection, Wound Complications, Post-Transplant Diabetes, Hemorrhagic Cystitis and Malignancy|AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy. Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0.|First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)|Safety population, which includes all participants who received any study medication.|||Events|||Number
2612743|NCT02029638|Secondary|Number of Adverse Events (AEs)- Including Infection, Wound Complications, Post-transplant Diabetes, Hemorrhagic Cystitis and Malignancy|AEs reported as an infection, wound complication, post-transplant diabetes, hemorrhagic cystitis and/or malignancy.|First Dose of Study Medication to End of Study (Up to 25 Months After Enrollment)|Safety population, which includes all participants who received any study medication.|||Events|||Number
2612744|NCT02029638|Secondary|Number of Days Post-Transplant to the First Episode of Acute Rejection Requiring Treatment|Number of days post-transplant to the first episode of acute rejection that required treatment. This includes acute rejection episodes requiring treatment that were not biopsy proven.|Transplant to End of Study (Up to 25 months After Enrollment)|Transplanted Per Protocol Participants who experienced acute rejection.|||Days||Standard Deviation|Mean
2612745|NCT02029638|Secondary|Number of Transplanted Participants With Chronic T Cell-Mediated or Antibody-Mediated Rejection|Outcome includes participants who experienced chronic T cell-mediated rejection, antibody-mediated rejection and progressive interstitial fibrosis/tubular atrophy (IF/TA), transplant glomerulopathy or chronic obliterative arteriopathy, without an alternative, non-rejection related cause. Reference: Banff 2007 Classification Renal Allograft Pathology definition of terms.|Transplant to End of Study (Up to 25 months After Enrollment)|Transplanted Per Protocol Participants|||Participants|||Count of Participants
2612746|NCT02029638|Secondary|Histological Severity of Biopsies Demonstrating Acute Rejection as Defined by Banff 2007 Classification Renal Allograft Pathology|This outcome includes results from biopsies with proven acute renal allograft rejection according to the 2007 Banff Classification Renal Allograft Pathology. A Banff result of indeterminate is not classified as rejection.|Transplant to End of Study (Up to 25 months After Enrollment)|Transplanted Per Protocol Participants|||participants|||Number
2612747|NCT02029638|Secondary|Number of Transplanted Participants With Acute Renal Allograft Rejection|Acute renal allograft rejection demonstrated either by biopsy or clinically (when a biopsy could not be performed). This measure includes participants with biopsy proven acute renal allograft rejection and those that have creatinine values 25% or greater relative to baseline for over 72 hours. Baseline serum creatinine is defined as the average of the lowest three serum creatinine values during 2 to 4 weeks post-transplant, excluding days on dialysis.|Transplant to End of Study (Up to 25 months After Enrollment)|Transplanted Per Protocol Participants|||Participants|||Count of Participants
2612748|NCT02029638|Secondary|Number of Transplanted Participants Who Died|Number of participant deaths after receiving a transplant per protocol.|Transplant to End of Study (Up to 25 months After Enrollment)|Transplanted Per Protocol Participants|||Participants|||Count of Participants
2612749|NCT02029638|Secondary|Duration in Days of Engraftment Syndrome in Transplanted Participants|Engraftment syndrome is a complication that can occur following bone marrow transplant. The presence of engraftment syndrome is diagnosed by monitoring the common symptoms, which include: fever, rash, fluid in the lungs, and serum creatinine values above 4 mg/dL occurring within a week of absolute neutrophil recovery (e.g., first day after three consecutive daily absolute neutrophil count ≥ 500 per µL), without apparent other cause. Duration (in days) is measured as the time from the start of the engraftment syndrome event to the end of the engraftment syndrome event.|Transplant to End of Study (Up to 25 months After Enrollment)|No statistical analyses provided for ‘Duration of Engraftment Syndrome in Transplanted Participants’ because no participants in the Per Protocol population experienced engraftment syndrome.||||||
2612750|NCT02029638|Secondary|Number of Transplanted Participants With Engraftment Syndrome|Engraftment syndrome is a complication that can occur following bone marrow transplant. The presence of engraftment syndrome is diagnosed by monitoring the common symptoms, which include: fever, rash, fluid in the lungs, and serum creatinine values above 4 mg/dL occurring within a week of absolute neutrophil recovery (e.g., first day after three consecutive daily absolute neutrophil counts ≥ 500 per µL), without apparent other cause.|Transplant to End of Study (Up to 25 months After Enrollment)|Transplanted Per Protocol Participants|||Participants|||Count of Participants
2612751|NCT02029638|Secondary|Duration in Days of Graft-versus-Host Disease in Transplanted Participants|Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells. Duration (in days) is measured as the time from the start of the GVHD event to the end of the GVHD event.|Transplant to Two Years Post-Transplant|Transplanted Per Protocol Participants|||Days||Standard Deviation|Mean
2612752|NCT02029638|Secondary|Severity of Graft-versus-Host Disease in Transplanted Participants|Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells. Severity of GVHD is based on skin, liver, and intestinal tract symptoms, ranging from I to IV, with IV being the worst. This measure counts the number of participants experiencing GVHD by severity.|Transplant to Two Years Post-Transplant|Transplanted Per Protocol Participants|||Participants|||Count of Participants
2612753|NCT02029638|Secondary|Number of Participants Experiencing an Incidence of Graft-versus-Host Disease Post-Transplant|Graft-versus-host disease (GVHD) is a medical complication that can occur after a person receives transplanted tissue, most commonly occurring after a bone marrow transplant. The white blood cells from the donated tissue recognize the tissue recipient's cells as foreign. These donor cells then attack the recipient's cells.|Transplant to Two Years Post-Transplant|Transplanted Per Protocol Participants|||Participants|||Count of Participants
2612754|NCT02029638|Primary|Percent of Participants Who Achieved Operational Tolerance|Operational tolerance is defined as remaining off all immunosuppression 52 weeks after completion of immunosuppression withdrawal, with no evidence of biopsy-proven allograft rejection and, with acceptable renal function defined as a serum creatinine that has increased no more than 25% above baseline at the primary endpoint visit. Baseline creatinine is defined as the average of the lowest three creatinine values during 2 to 4 weeks post-transplant, excluding days on dialysis. The endpoint is summarized with a two-sided, 95% exact binomial confidence interval.|Transplantation through 52 Weeks after Discontinuation of All Immunosuppression|Transplanted Per Protocol Participants|||Percent of participants||95% Confidence Interval|Number
2612755|NCT02029521|Secondary|Severity of Less Than 2 Bowel Movements Per Week|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
2612756|NCT02029521|Secondary|Frequency of Less Than 2 Bowel Movements Per Week|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
2612757|NCT02029521|Secondary|Severity of More Than 2 Bowel Movements Per Day|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
2612758|NCT02029521|Secondary|Frequency of More Than 2 Bowel Movements Per Day|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
2612759|NCT02029521|Secondary|Severity of Diarrhea|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
2612760|NCT02029521|Secondary|Frequency of Diarrhea|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
2612761|NCT02029521|Secondary|Severity of Heart Burn|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
2612762|NCT02029521|Secondary|Frequency of Heart Burn|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
2612763|NCT02029521|Secondary|Severity of Vomiting|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
2612764|NCT02029521|Secondary|Frequency of Vomiting|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
2612765|NCT02029521|Secondary|Severity of Nausea|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
2612766|NCT02029521|Secondary|Frequency of Nausea|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
2612767|NCT02029521|Secondary|Severity of Bloating|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
2612768|NCT02029521|Secondary|Frequency of Bloating|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
2612769|NCT02029521|Secondary|Severity of Lack of Appetite|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
2612770|NCT02029521|Secondary|Frequency of Lack of Appetite|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
2612771|NCT02029521|Secondary|Severity of Flatulence|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
2612772|NCT02029521|Secondary|Frequency of Flatulence|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
2612773|NCT02029521|Secondary|Severity of Belching|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
2612774|NCT02029521|Secondary|Frequency of Belching|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
2612775|NCT02029521|Secondary|Severity of Abdominal Pain|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe|6 months||||participants|||Number
2612776|NCT02029521|Secondary|Frequency of Abdominal Pain|Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent|6 months||||participants|||Number
2612777|NCT02029521|Secondary|Bacteriology|Expectorated sputum or throat swab|6 Months||||participants|||Number
2612778|NCT02029521|Secondary|Alanine Aminotransferase (ALT)|ALT was measured to determine if liver function was affected by treatment over the course of the study.|6 Months|All participants.|||units per liter||Standard Deviation|Mean
2612795|NCT02029495|Primary|American College of Rheumatology (ACR) 20 Response|An ACR20 response is defined as at least 20% improvement of tender and swollen joint counts combined with at least 20% improvement in at least 3 of the following 5 parameters: Patients Global Assessment, PtGA of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and either Erythrocycte sedimentation rate (ESR) or C-Reactive protein (CRP) (ACR components).|16 weeks||||percentage of participants||95% Confidence Interval|Number
2612796|NCT02029417|Primary|Frequency of Adverse Events, Graded According to NCI CTCAE v4.0|Maximum grade per participant of any AE.|Up to 30 days after last dose of study drugs|All treated and eligible patients.|||participants|||Number
2612797|NCT02029417|Primary|Proportion of the Evaluable Population of Interest Who Experience a Complete Response in the Poor and Good Prognosis Groups|Defined as recovery of morphologically normal bone marrow (< 5% blasts) and blood counts (absolute neutrophil count >= 1x10^9/L, platelet counts >= 100x10^9/LO) and rare circulating leukemic blasts or evidence of extramedullary disease. Analyzed using exact binomial probabilities in a two-stage design. The number of responses will be tabulated.|Up to 4 years|Due to the study's early termination and low accrual, data were not collected for this assessment.||||||
2612798|NCT02029274|Secondary|Change From Baseline in 6 Minutes Walking Distance (6-MWD) Test||baseline, 6 months|PD analysis set|||meters||Standard Deviation|Mean
2612799|NCT02029274|Secondary|Change From Baseline in Manual Muscle Testing - 24 Muscles (MMT-24) Score|Each muscles tested was evaluated on a 0-10 scale where 0 indicated the weakest muscle score and 10 indicated the strongest muscle score. the total MMT24 score ranged from 0-240, where an increasing trend in the values indicates improvement. A positive change from baseline indicates improvement.|baseline, 3 months|PD analysis set|||score on a scale||Standard Error|Least Squares Mean
2612800|NCT02029274|Secondary|Peripheral Blood Lymphocyte Counts|Absolute lymphocyte counts|baseline, 6 months|Safety analysis set: the safety analysis set included all patients that received any study drug.|||10^9 cells/Liter||Standard Deviation|Mean
2612801|NCT02029274|Secondary|BAF312 Plasma Concentration||6 months|Pharmacokinetics (PK) analysis set: The PK analysis set included all patients with available PK data and no protocol deviations with relevant impact on PK data.|||ng/ml||Full Range|Median
2612802|NCT02029274|Primary|Change From Baseline in Manual Muscle Testing - 24 Muscles (MMT-24) Score|Each muscles tested was evaluated on a 0 - 10 scale where 0 indicated the weakest muscle score and 10 indicated the strongest muscle score. The total MMT24 score ranged from 0 - 240, where an increasing trend in the values indicates improvement. A positive change from baseline indicates improvement.|Baseline, 6 months|The pharmacodynamic (PD) analysis set, which included all randomized participants, was considered for the analysis. Participants with valid baseline MMT24 score and at least one valid post baseline MMT24 score were included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
2612803|NCT02029235|Secondary|Efficacy Comparison of Pain Relief|"Subjects asked to fill out a patient diary recording their pain relief (on a Likert scale) one hour after taking study medication every 4 hours.~Daily average pain relief scores are reported as a score on a scale of 0-3, with higher score meaning better outcome.~The daily average pain relief scores were assessed daily for 1 week post-operatively, then compared using generalized linear mixed-effects models"|1 week postoperatively||||score on a scale (0-3, higher = better)||Full Range|Mean
2612804|NCT02029235|Primary|Efficacy Comparison of Pain Intensity Level|"Subjects asked to fill out a patient diary recording their pain intensity level (on 100mm Visual Analog Scale) prior to taking study medication every 4 hours.~The daily average pain intensity levels are reported as a score on a scale of 0-100, with higher score meaning worse outcome.~The daily average pain levels were assessed daily for 1 week post-operatively, then compared between the 2 groups using a two-group Student's t-test."|1 week post-operatively||||score on a scale (0-100, higher = worse)||Full Range|Mean
2612805|NCT02029196|Secondary|Exhaled Carbon Monoxide|Level of exhaled carbon monoxide at Week 12|12 weeks|Measure performed on subjects who completed the 12-week study (286 in the e-vapour product arm and 100 in the conventional cigarette arm).|||parts per million (ppm)||Standard Deviation|Mean
2612806|NCT02029196|Primary|Adverse Events|Frequency of adverse events|12 weeks|All subjects who used the study product at least once.|||percentage of adverse events||95% Confidence Interval|Least Squares Mean
2612807|NCT02029040|Secondary|Rate of Hospitalizations||24 hours||||participants|||Number
2612808|NCT02029040|Primary|Respiratory Assessment Change Score (RACS)|The primary outcome variable is the Respiratory Assessment Change Score (RACS) which is a sum of the change in the Respiratory Distress Assessment Instrument (RDAI)score plus a standardized score for the change in respiratory rate; the change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate.The RDAI score is the sum of the row scores, with total range 0 to 17; higher scores indicate more severe disease.|5-15 minutes||||score on a scale||95% Confidence Interval|Mean
2612809|NCT02028871|Other Pre-specified|Nicotine Cravings Measured by Questionnaire of Smoking Urges|Range: 7-70. Higher scores mean worse outcome|210 minutes||||score on a scale||Standard Error|Mean
2612810|NCT02028871|Primary|Amount Eaten in Taste Test||90 minutes||||grams||Standard Deviation|Mean
2612811|NCT02028780|Secondary|AUEC2-12|"Area under the effect curve over the time interval from 2 to 12h, AUEC2-12 on Days 4 and 11 for diluted thrombin time (dTT).~For dose groups 5 to 7(day4-Part-II): 74h, 74.5h, 75h, 76h, 78h, 80h, 82h, 84h on day 4. For dose groups 5 to 7(day11-Part-II): 242h, 242.083h, 242.167h, 242.5h, 243h, 244h, 246h, 248h, 250h, 252h. For dose groups 8(day4-Part-II): 74.5 h, 78 h, 84 h on day 4. For dose groups 8(day11-Part-II): 242h, 242.083h,242.25h, 242.333h, 243.333h, 244h, 246h, 248h, 252h on day 11.~AUEC is calculated by multiplying the ratio (Value at each time point/Ebase, unit of Vaue is [s] and Ebase is value [s] at baseline) by time. Therefore, Unit for AUEC2-12 is [h]."|Day 4 and Day 11 (Part II); Time frame are provided in detail in the Description section|Pharmacodynamic set (PDS): The PDS comprised all subjects in the TS who provided at least 1 evaluable predose and 1 on-treatment pharmacodynamic observation.|||h||Standard Deviation|Mean
2612812|NCT02028780|Secondary|Ae0-73 for the Dose Group 4 in the Part I|Amount of the analyte excreted in urine over the time interval 0-73|For dose group 4 (day1 to day4-Part-1): 0-7h, 7-13h, 13-25h, 25-49h, 49-73h|PKS set. The results from dose group 4 has been disclosed, because only dose group 4 had 1hr infusion, Ae 0-73 was reported, instead of Ae0-72.|||μmol||Geometric Coefficient of Variation|Geometric Mean
2612813|NCT02028780|Secondary|Ae0-72 for Idarucizumab in the Part I & Part II.|Amount of idarucizumab eliminated in urine over the time interval 0-72. Time frame: For dose groups 1 to 3 (day1 to day4-Part-1):0-4 h, 4-8 h, 8-12 h, 12-24 h, 24-48 h, 48-72 h. For dose groups 5 to 7 (day 11 to day14-Part-II): 0-4 h, 4-8 h, 8-10 h, 10-12 h,12-24 h, 24-48 h, and 48-72 h. For dose groups 8 (day11 to day14-Part-II): 0-4h, 4-8 h, 8-10 h, 10-24 h, 24-48 h, 48-72 h.|Day 1 to 4 (Part I) and Day 11 to 14 (Part II); Time frame are provided in detail in the Description section|PKS set. Ae 0-72 data is not available for BI8000mg_1h (Dose group 4 - Part I) due to longer infusion time resulting different urine collection interval. Instead, Ae 0-73 is presented for BI8000mg_1h as separate endpoint.|||μmol||Geometric Coefficient of Variation|Geometric Mean
2612814|NCT02028780|Secondary|AUC0-inf for Idarucizumab in the Part I & Part II.|"Area under the concentration-time curve of the analyte in plasma for idarucizumab over the time interval from 0 extrapolated to infinity.~Time frame: For dose group 1 to 3 (Day 1 to 3-Part-I): predose, 0 (end of infusion), 0.033h, 0.083, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h. For dose group 4 (Day 1 to 3-Part-I): predose, −0.5h, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 48h. For dose group 5-7 (Day11 to Day13-Part II): predose, 242h (end of infusion), 242.033h, 242.083h, 242.167h, 242.25h, 242.5h, 242.75h, 243h, 243.5h, 244h, 244.5h, 245h, 246h, 248h, 250h, 252h, 254h, 258h, 266h, 290h.For dose group 8 (day11 to Day13-Part II): predose, 242h (end of infusion), 242.083h, 242.25h, 242.333h, 242.367h, 242.5h, 242.833h, 243.333h, 244h, 245h, 246h, 248h, 252h, 254h, 266h, 290h, 314h."|Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section|PKS set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2612815|NCT02028780|Secondary|Cmax for Idarucizumab in the Part I & Part II.|Maximum measured concentration of the analyte in plasma for idarucizumab Time frame: For dose group 1 to 3 (Day 1 to 3-Part-I): predose, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h. For dose group 4 (Day 1 to 3-Part-I): predose, −0.5h, 0 (end of infusion), 0.033h, 0.083h, 0.167h, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h, 16h, 24h, 48h. For dose group 5-7 (Day11 to Day13-Part II): predose, 242h (end of infusion), 242.033h, 242.083h, 242.167h, 242.25h, 242.5h, 242.75h, 243h, 243.5h, 244h, 244.5h, 245h, 246h, 248h, 250h, 252h, 254h, 258h, 266h, 290h.For dose group 8 (day11 to Day13-Part II): predose, 242h (end of infusion), 242.083h, 242.25h, 242.333h, 242.367h, 242.5h, 242.833h, 243.333h, 244h, 245h, 246h, 248h, 252h, 254h, 266h, 290h, 314h.|Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section|PKS set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2612816|NCT02028780|Secondary|AUC2-12,ss on Days 4 and 11 for Unbound Sum Dabigatran (Part II).|"Area under the concentration-time curve of the dabigatran in plasma at steady state over the time interval 2 hours-12 hours.~Time Frame: For dose group 5 to 7 (Day 1 to 3-Part-I):74hours (h), 74.5h, 75h, 76h, 78h, 80h, 82h, 84h, For dose group 8 (Day 1 to 3-Part-I): 74h, 74.5h, 75h, 76h, 78h, 80h, 82h, 84h and For dose group 5-7 (Day11 to Day13-Part II):242h, 242.167h, 242.5h, 243h, 244h,246h, 248h, 250h, 252h. For dose group 8 (Day11 to Day13-Part II):242h, 242.083h, 242.25h, 242.333h, 243.333h, 244h, 246h, 248h, 252h."|Day 4 (Part I) and Day 11 (Part II). Time frame are provided in detail in the Description section|PKS set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2612817|NCT02028780|Secondary|Ae0−74,ss on Days 4 and 11 for Sum Dabigatran (Part II)|Amount of analyte eliminated in urine at steady state from the time point 0 hours to time point 74 hours.|0-2 h, 2-6 h, 6-10 h, 10-12 h,12-14h, 14-26 h, 26-50 h, 50-74 h after drug administration of dabigatran etexilate on Day 4 and Day 11.|PKS set: This subject set included all subjects who received the idarucizumab and who had at least one pharmacokinetic parameter. For the Part 2, subjects who had the emesis with onset at or before twice the median tmax of dabigatran were not included in this set.|||μg||Geometric Coefficient of Variation|Geometric Mean
2612818|NCT02028780|Primary|Percentage of Subjects With Drug-related Adverse Events in Part 1 and Part 2|Percentage of subjects with drug-related adverse events in Part 1 and Part 2.|From first drug administration until 13 weeks after the last drug administration, upto 98 days (Part-I) & upto 108 days (Part-II)|Treated set (TS)|||Percentage of participants|||Number
2612819|NCT02028767|Secondary|AUC (0-infinity) (Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|AUC (0-infinity) (Area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity)|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: includes all subjects of the TS who provided at least 1 observation for at least 1 primary pharmacokinetic endpoint, and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2612820|NCT02028767|Primary|Cmax (Maximum Measured Concentration of Metformin in Plasma)|Cmax (maximum measured concentration of metformin in plasma)|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: includes all subjects of the TS who provided at least 1 observation for at least 1 primary pharmacokinetic endpoint, and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2612821|NCT02028767|Primary|AUC (0-tz) (Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point)|AUC (0-tz) (area under the concentration-time curve of metformin in plasma over the time interval from 0 to the last quantifiable data point)|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic set (PKS): includes all subjects of the TS who provided at least 1 observation for at least 1 primary pharmacokinetic endpoint, and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2612873|NCT02028676|Secondary|CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 72 Weeks After Baseline|Number of participants with HIV RNA viral load <80 copies/ml 72 weeks after baseline. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes.|72 weeks|Viral loads were assayed retrospectively in a random subset of children|||participants|||Number
2612822|NCT02028754|Secondary|Subjective Symptom Total Score in the Study Eye|The following 11 subjective symptoms are evaluated in the study eye: foreign body sensation, photophobia, itching, pain in the eye, dry eye, eye heaviness, blurred vision, eye fatigue, eye discomfort, eye secretions and tears. Each of these symptoms is divided into 4 classes: no symptom=0; occasional symptoms=1; intermittent mild symptoms=2; and persistent obvious symptoms=3. The total score ranged from 0 (best) to 33 (worst).|Day 7, Day 30|All patients with data at this time point|||Scores on a Scale||Standard Deviation|Mean
2612823|NCT02028754|Secondary|Ocular Surface Disease Index (OSDI) Questionnaire Score in the Study Eye|The OSDI is a 12-question survey for patients to document their dry eye disease symptoms in the study eye. The OSDI consists of a 5-point scale (0=none of the time and 4 = all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability).|Day 7, Day 30|All patients with data at this time point|||Scores on a Scale||Standard Deviation|Mean
2612824|NCT02028754|Secondary|Results of Schirmer I Test With Anesthetics in the Study Eye|The Schirmer I test consists of anesthetic drops being placed into the lower eyelid of the study eye. Patients then close their eyes. Test paper is placed on the lower eyelid of the patient's closed eyes. The paper is then removed and the moisture length on the paper recorded. Shorter distances indicate worse dry eye symptoms.|Day 7, Day 30|All patients with data at this time point|||Millimeters||Standard Deviation|Mean
2612825|NCT02028754|Secondary|Lissamine Green Staining Score in the Study Eye|Conjunctival and corneal staining are evaluated following ocular administration of lissamine green dye in the study eye. The conjunctiva is the clear membrane covering the white surface of the eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The conjunctiva and cornea are divided into 5 regions that are scored based on the extent of staining. Scores range from 0 to 3 points: 0=non-staining, 1=staining range < 1/2 of the conjunctiva and cornea, 2=staining range ≥ 1/2 of the conjunctiva and cornea, and 3=regional whole staining of the conjunctiva and cornea. The total score ranges from 0 to 15 points. The higher the grade score, the worse the dry eye condition.|Day 7, Day 30|All patients with data at this time point|||Scores on a Scale||Standard Deviation|Mean
2612826|NCT02028754|Secondary|Fluorescein Staining Score in the Study Eye|The cornea is evaluated following ocular administration of fluorescein stain in the study eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The cornea is divided into 3 regions. Each region is scored according to the extent of staining, with scores ranging from 0 to 3 points: 0=non-staining, 1=staining range < 1/2 of the cornea, 2=staining range ≥ 1/2 of the cornea, and 3=regional whole staining of the cornea. The total score ranges from 0 to 9 points. The higher the staining score, the worse the dry eye condition.|Day 7, Day 30|All patients with data at this time point|||Scores on a Scale||Standard Deviation|Mean
2612827|NCT02028754|Primary|Tear Break-Up Time (TBUT) in the Study Eye|TBUT is the time required for dry spots to appear on the surface of the study eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film.|Day 30|All patients with data at this time point|||Seconds||Standard Deviation|Mean
2612828|NCT02028754|Primary|Tear Break-Up Time (TBUT) in the Study Eye|TBUT is the time required for dry spots to appear on the surface of the study eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film.|Day 7|All patients with data at this time point|||Seconds||Standard Deviation|Mean
2612829|NCT02028715|Secondary|Length of Stay|Mean length of post-operative stay in days|Surgery to discharge|Participants experiencing adverse event leading to increased length of stay were not analyzed.|||Days||Standard Deviation|Mean
2612830|NCT02028715|Secondary|Patient Satisfaction - Pruritis at 24 Hours, 48 Hours, and Discharge|Subjects will rate their overall satisfaction with pruritis control on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree|At 24 hours, 48 Hours, and Discharge (up to 7 days)|Participants who completed the pruritus satisfaction survey|||score on a scale||Standard Deviation|Mean
2612831|NCT02028715|Secondary|Patient Satisfaction - Bloating at 24 Hours, 48 Hours, and Discharge|Subjects will rate their overall satisfaction with bloating on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree|At 24 hours, 48 Hours, and Discharge (up to 7 days)|Participants who completed the bloating satisfaction survey|||score on a scale||Standard Deviation|Mean
2612832|NCT02028715|Secondary|Patient Satisfaction - Nausea Control at 24 Hours, 48 Hours, and Discharge|Subjects will rate their overall satisfaction with nausea control on a 5-point Likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree|At 24 hours, 48 Hours, and Discharge (up to 7 days)|Participants who completed the nausea control survey.|||score on a scale||Standard Deviation|Mean
2612833|NCT02028715|Secondary|Patient Satisfaction - Pain Control at 24 Hours, 48 Hours, and Discharge|Subjects will rate their overall satisfaction with pain control on a 5-point Likert scale: 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree|At 24 hours 48 hours, and discharge (up to 7 days)|Participants who completed the pain satisfaction survey at 24 hours|||score on a scale||Standard Deviation|Mean
2612834|NCT02028715|Secondary|Return of Bowel Function|Time to return of bowel function (passage of flatus) in hours|Duration of hospital stay (up to 7 days).|Only participants with documented return of bowel function prior to discharge were analyzed.|||Hours||Standard Deviation|Mean
2612835|NCT02028715|Primary|Opioid Rescue - 48 Hours|Mean number opioid rescue in the first 48 hours calculated by converting all opiates to intravenous morphine|First 48 hours including pre-operative and intra-operative medications||||Milligrams of intravenous morphine equiv||Standard Deviation|Mean
2612836|NCT02028676|Secondary|Cotrimoxazole: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)|Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks.|Mean over median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||% of visits reporting missed pills||Standard Deviation|Mean
2612837|NCT02028676|Secondary|Cotrimoxazole: New Serious Adverse Events Not Solely Related to HIV|Number of participants with a new serious adverse event not solely related to HIV, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||participants|||Number
2612840|NCT02028676|Secondary|Cotrimoxazole: Body Mass Index-for-age Z-score|Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||age-adjusted z-score||Standard Deviation|Mean
2612841|NCT02028676|Secondary|Cotrimoxazole: Height-for-age Z-score|Age-adjusted change in height-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||age-adjusted z-score||Standard Deviation|Mean
2612842|NCT02028676|Secondary|Cotrimoxazole: Weight-for-age Z-score|Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||age-adjusted z-score||Standard Deviation|Mean
2612843|NCT02028676|Secondary|Cotrimoxazole: All-cause Mortality|Number of participants who died, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||participants|||Number
2612844|NCT02028676|Secondary|Cotrimoxazole: New WHO Stage 4 Event or Death|Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.5 years)||||participants|||Number
2612845|NCT02028676|Secondary|Cotrimoxazole: New WHO Stage 3 Severe Recurrent Pneumonia or Diarrhoea|Number of participants with a new WHO stage 3 severe recurrent pneumonia or diarrhoea, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||participants|||Number
2612846|NCT02028676|Secondary|Cotrimoxazole: New WHO Stage 3 or 4 Event or Death|Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.5 years)||||participants|||Number
2612847|NCT02028676|Secondary|Cotrimoxazole: New Severe Pneumonia|Number of participants with a new severe pneumonia, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||participants|||Number
2612848|NCT02028676|Secondary|Cotrimoxazole: New Clinical and Diagnostic Positive Malaria|Number of participants with a new clinical and diagnostic positive malaria, to be analysed using time-to-event methods. Diagnostic positive by either microscopy (thick film) or rapid diagnostic test (RDT)|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||participants|||Number
2612849|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)|Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks.|Mean over median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)||||% of visits reporting missed pills||Standard Deviation|Mean
2612850|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 96 Weeks|Number of participants reporting missing any doses of ART in the last 4 weeks by self-report at 96 weeks.|96 weeks after randomization to once- versus twice-daily|All participants completing the questionnaire|||participants|||Number
2612851|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks) at 48 Weeks|Number of participants reporting missing any doses of ART in the last 4 weeks by self-report at 48 weeks.|48 weeks after randomization to once- versus twice-daily|All participants completing the questionnaire|||participants|||Number
2612852|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: New Serious Adverse Events Not Solely Related to HIV|Number of participants with a new serious adverse event not solely related to HIV, to be analysed using time-to-event methods|Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)||||participants|||Number
2612853|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV|Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods|Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)||||participants|||Number
2612854|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Body Mass Index-for-age Z-score|Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)||||age-adjusted z-score||Standard Deviation|Mean
2613883|NCT02015754|Secondary|Number of Participants With Change in Carcinoembryonic Antigen (CEA)|CEA measurements pre- and post- DEBIRI treatment will be recorded to ascertain if it is predictive of survival.|6 weeks|2 out of original 14 patients had no CEA measurements.|||participants|||Number
2612855|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Weight-for-age Z-score|Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)||||age-adjusted z-score||Standard Deviation|Mean
2612856|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Height-for-age Z-score|Age-adjusted change in height-for-age Z-score over all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)||||age-adjusted z-score||Standard Deviation|Mean
2612857|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 3 or 4 Event or Death|Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)||||participants|||Number
2612858|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: New WHO Stage 4 Event or Death|Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)||||participants|||Number
2612859|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: All-cause Mortality|Number of participants who died, to be analysed using time-to-event methods|Median 2 years (from randomization to 16 March 2012; maximum 2.6 years)||||participants|||Number
2612860|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 96|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured|Randomisation to once vs twice daily, week 96|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured|||cells per mm3||Standard Deviation|Mean
2612861|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 72|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured|Baseline, week 72|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured|||cells per mm3||Standard Deviation|Mean
2612862|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in Absolute CD4 to Week 48|Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)|Randomisation to once vs twice daily, week 48|All participants aged >5 years at randomization to once versus twice daily alive in follow-up with CD4 measured|||cells per mm3||Standard Deviation|Mean
2612863|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 96||Randomisation to once vs twice daily, week 96|All participants alive in follow-up with CD4%|||percentage of lymphocytes||Standard Deviation|Mean
2612864|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 72||Baseline, week 72|All participants alive in follow-up with CD4%|||percentage of total lymphocytes||Standard Deviation|Mean
2612865|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Change From Baseline in CD4% to Week 48||Randomisation to once vs twice daily, week 48|All participants alive in follow-up with CD4%|||percentage of total lymphocytes||Standard Deviation|Mean
2612866|NCT02028676|Secondary|Once Versus Twice Daily Abacavir+Lamivudine: Suppression of HIV RNA Viral Load 96 Weeks After Randomisation|Number of participants with HIV RNA viral load <80 copies/ml at 96 weeks. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes.|96 weeks|All participants with viral load assayed in stored specimens (98% of those randomized)|||participants|||Number
2612867|NCT02028676|Secondary|LCM vs CDM, Induction ART: Adherence to ART as Measured by Self-reported Questionnaire (Missing Any Pills in the Last 4 Weeks)|Binary outcome measure: missed any doses of ART in the last 4 weeks by self-report. Mean calculated across all 12-weekly visits attended over the whole follow-up (no specific timepoint prespecified), giving the percentage of visits attended where the carer/participant reported missing any pills in the last 4 weeks.|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||% of visits reporting missed pills||Standard Deviation|Mean
2612868|NCT02028676|Secondary|LCM vs CDM, Induction ART: New ART-modifying Adverse Event|Number of participants with a new ART-modifying adverse event, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
2612869|NCT02028676|Secondary|LCM vs CDM, Induction ART: New Serious Adverse Events Not Solely Related to HIV|Number of participants with a new serious adverse events not solely related to HIV, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
2612870|NCT02028676|Secondary|LCM vs CDM, Induction ART: New Grade 3 or 4 Adverse Event Definitely/Probably or Uncertainly Related to ART|Number of participants with a new grade 3 or 4 adverse event definitely/probably or uncertainly related to ART, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
2612871|NCT02028676|Secondary|LCM vs CDM, Induction ART: Cessation of First-line Regimen for Clinical/Immunological Failure|Number of participants stopping their first-line regimen for clinical/immunological failure, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
2612872|NCT02028676|Secondary|CDM vs LCM, Induction ART: Suppression of HIV RNA Viral Load 144 Weeks After Baseline|Number of participants with HIV RNA viral load <80 copies/ml 144 weeks after baseline. Threshold for suppression <80 copies/ml as samples had to be diluted due to low volumes.|144 weeks|Viral load was assayed retrospectively at week 144 on a random subset of participants, plus all those aged <5 years at enrolment|||participants|||Number
2612874|NCT02028676|Secondary|LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 144|Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)|Baseline, week 144|All participants alive in follow-up with CD4|||absolute cells per mm3||Standard Error|Mean
2612875|NCT02028676|Secondary|LCM vs CDM, Induction ART: Change From Baseline in Absolute CD4 to Week 72|Estimated in those >5 years at enrolment, in whom absolute CD4 is meaningful. (In uninfected children, CD4 decreases with age during early childhood.)|Baseline, week 72|All participants alive in follow-up with CD4|||absolute cells per mm3||Standard Error|Mean
2612876|NCT02028676|Secondary|LCM vs CDM: Change From Baseline in CD4% to Week 144||Baseline, week 144|All participants alive in follow-up with CD4% (95% completeness)|||percentage of total lymphocytes||Standard Error|Mean
2612877|NCT02028676|Secondary|LCM vs CDM: Change From Baseline in CD4% to Week 72||Baseline, week 72|All participants alive in follow-up with CD4% (97% completeness)|||percentage of total lymphocytes||Standard Error|Mean
2612878|NCT02028676|Secondary|LCM vs CDM, Induction ART: Body Mass Index-for-age Z-score|Age-adjusted change in body mass index-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 4 years (maximum 5 years)||||age-adjusted z-score||Standard Deviation|Mean
2612879|NCT02028676|Secondary|LCM vs CDM, Induction ART: Height-for-age Z-score|Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 4 years (maximum 5 years)||||age-adjusted z-score||Standard Deviation|Mean
2612880|NCT02028676|Secondary|LCM vs CDM, Induction ART: Weight-for-age Z-score|Age-adjusted change in weight-for-age Z-score at all 12-weekly visits attended over the whole follow-up, no specific timepoint prespecified. Mean and SD are time-averaged area under the change curve calculated using the trapezoidal rule. Z-scores calculated using UK norms which cover the full age range of children (Cole, T. J., J. V. Freeman, and M. A. Preece. 1998. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Statistics in Medicine 17(4): 407-29).|Baseline and a median of 4 years (maximum 5 years)||||age-adjusted z-score||Standard Deviation|Mean
2612881|NCT02028676|Secondary|LCM vs CDM, Induction ART: New or Recurrent WHO Stage 3 or 4 Event or Death|Number of participants with a new or recurrent WHO stage 3 or 4 event or death, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
2612882|NCT02028676|Secondary|LCM vs CDM, Induction ART: New WHO Stage 3 or 4 Event or Death|Number of participants with a new WHO stage 3 or 4 event or death, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
2612883|NCT02028676|Secondary|Induction ART: New WHO Stage 4 Event or Death|Number of participants with a new WHO stage 4 event or death, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
2612884|NCT02028676|Secondary|LCM vs CDM, Induction ART: All-cause Mortality|Number of participants who died from any cause, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
2612885|NCT02028676|Primary|Cotrimoxazole: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV|Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||participants|||Number
2612886|NCT02028676|Primary|Cotrimoxazole: New Hospitalisation or Death|Number of participants with a new hospitalisation or death, to be analysed using time-to-event methods|Median 2 years (from cotrimoxazole randomization to 16 March 2012; maximum 2.5 years)||||participants|||Number
2612887|NCT02028676|Primary|Once Versus Twice Daily Abacavir+Lamivudine: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV, Judged Definitely/Probably or Uncertain Whether Related to Lamivudine or Abacavir|Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, judged definitely/probably or uncertain whether related to lamivudine or abacavir, to be analysed using time-to-event methods|Median 2 years (from once vs twice daily randomization to 16 March 2012; maximum 2.6 years)||||participants|||Number
2612888|NCT02028676|Primary|Once Versus Twice Daily Abacavir+Lamivudine: Suppressed HIV RNA Viral Load 48 Weeks After Randomisation|Number of participants with HIV RNA viral load <80 copies/ml at 48 weeks. Measured retrospectively on stored plasma specimens: due to low stored volumes from some children, samples had to be diluted and therefore a threshold of <80 copies/ml was used to indicate suppression.|48 weeks|All randomized participants with VL result from stored plasma specimen (available for 661/669, 99%, randomized participants)|||participants|||Number
2612889|NCT02028676|Primary|Induction ART: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV|Number of participants with a new grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
2612890|NCT02028676|Primary|Induction ART: Change From Baseline in CD4% to 144 Weeks From ART Initiation||Baseline, 144 weeks|All participants alive in follow-up with CD4% (95% completeness)|||percentage of total lymphocytes||Standard Error|Mean
2612891|NCT02028676|Primary|Induction ART: Change From Baseline in CD4% 72 Weeks After ART Initiation||Baseline, 72 weeks|All participants alive at 72 weeks with CD4 measured (completeness in those in follow-up was 96.6%).|||percentage of total lymphocytes||Standard Error|Mean
2614242|NCT02013674|Secondary|Difference in Left Ventricular Volume|Difference in left ventricular end diastolic and end systolic volume will be assessed via CT|Baseline, 12 months|Not all participants were able to complete the procedure.|||ml||Full Range|Median
2612892|NCT02028676|Primary|LCM vs CDM: New Grade 3 or 4 Adverse Event (AE), Not Solely Related to HIV|Number of participants with a new Grade 3 or 4 adverse event (AE), not solely related to HIV, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)||||participants|||Number
2612893|NCT02028676|Primary|LCM vs CDM: Disease Progression to a New WHO Stage 4 Event or Death|Number of participants with disease progression to a new WHO stage 4 event or death, to be analysed using time-to-event methods|Median 4 years (from randomization to 16 March 2012; maximum 5 years)|All randomized participants (time-to-event)|||participants|||Number
2612894|NCT02028325|Primary|Concordance Between Surgical Impression of Residual Lesion and Appearance on Post-operative Imaging|We will perform fluorescein fluorescence/angiography at surgery and assess if fluorescence reveals any residual tumor or vascular lesion (aneurysm, arteriovenous malformation, or arteriovenous fistula) following surgical intervention. For subjects with brain tumors we will then perform a regular postoperative MRI and assess if there was any residual tumor and measure the accuracy of fluorescein fluorescence to assess the amount of the residual tumor seen on the postoperative MRI. Similarly, for the aneurysms or other vascular lesions, we will perform a regular postoperative angiogram and assess the accuracy of fluorescein angiography results in estimating the amount of residual lesion.|up to 1 week. For subjects where clinical post-operative MRI/angiography was not performed within 7 days, MRI/angiography completed within 3 months post-operatively was utilized for evaluation.||||participants|||Number
2612895|NCT02028169|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Treatment-Related Adverse Events (AEs) Up to Month 9|Number of participants with any serious adverse event (SAE) occurring during treatment with anti-TNF agents and/or participants who discontinued treatment due to SAEs or AEs which were caused by the treatment with anti-TNF agents during the course of treatment. An SAE is defined as an event that: results in the death; is life-threatening; results in an admission to the hospital or prolongation of hospitalization; is a congenital anomaly; results in a condition that substantially interferes with the activities of daily living of a study subject; is an important medical event according to the Investigator.|Up to Month 9|All participants|||Participants|||Count of Participants
2612896|NCT02028169|Secondary|Participant's Assessment of Pain and Fatigue VAS Up to Month 9|A VAS was used to measure the participant's assessment of pain and fatigue. For this assessment a 10-point scale was used (0: very well; 10: very poor).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
2612897|NCT02028169|Secondary|Participant's Assessment of Total Back Pain VAS Up to Month 9|A VAS was used to measure the participant's assessment of back pain. For this assessment a 10-point scale was used (0: very well; 10: very poor).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
2612898|NCT02028169|Secondary|Participant's Assessment of Nocturnal Back Pain and Fatigue VAS Up to Month 9|A VAS was used to measure the participant's assessment of nocturnal back pain and fatigue. For this assessment a 10-point scale was used (0: very well; 10: very poor).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
2612899|NCT02028169|Secondary|Physician's Global Assessment of Disease Activity VAS Up to Month 9|A VAS was used to measure the physician's assessment of disease activity. For this assessment a 10-point scale was used (0: very well; 10: very poor).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
2612900|NCT02028169|Secondary|Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Up to Month 9|A VAS was used to measure the participant's assessment of disease activity. For this assessment a 10-point scale was used (0: very well; 10: very poor).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
2612901|NCT02028169|Secondary|C-reactive Protein (CRP) Up to Month 9|CRP values were measured as an inflammatory parameter. Low CRP values mean less inflammation.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||mg/dL||Standard Deviation|Mean
2612902|NCT02028169|Secondary|Erythrocyte Sedimentation Rate (ESR) Up to Month 9|ESR values were measured as an inflammatory parameter. Low ESR values mean less inflammation.|Up to Month 9|Participants with an assessment at given time point.|||mm/h||Standard Deviation|Mean
2612903|NCT02028169|Secondary|Levels of Rheumatoid Factor||Up to Month 9|Since sufficient data could not be collected, this analysis was not performed.||||||
2612904|NCT02028169|Secondary|Number of Tender Joints Up to Month 9|Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The presence of tenderness is scored 1 and no tenderness is 0; range of score is 0-28, with higher scores indicating more tender joints.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||tender joints||Standard Deviation|Mean
2612905|NCT02028169|Secondary|Number of Swollen Joints Up to Month 9|Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The presence of swelling is scored 1 and no swelling is 0; range of score is 0-28, with higher scores indicating more swollen joints.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||swollen joints||Standard Deviation|Mean
2612906|NCT02028169|Secondary|Dactylitis Score Up to Month 9|A total of 20 digits were assessed as entire digits, looking for signs of tender dactylitis. Dactylitis is defined as a uniform swelling of the digits where the joints cannot be defined. Investigators entered scores between 0 (no swelling or pain) and 6 (most severe swelling and pain).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
2612907|NCT02028169|Secondary|Maastricht Ankylosing Spondylitis Enthesitis Scale (MASES) Up to Month 9|For calculation of the enthesitis (tenderness) score, MASES was used in practice by the physicians. This scale takes into account the sites (first costochondral joint, seventh costochondral joint, posterior superior iliac spine, anterior superior iliac spine, iliac crest, fifth lumbar spinous process and proximal insertion of the Achilles tendon) and they scored from 0 to 13. Minimum tenderness score was 0; maximum tenderness score was 13.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
2612908|NCT02028169|Secondary|Disease Activity Score (DAS 28) Up to Month 9|"The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity. Participants were classified according to their scores as below:~DAS28 > 5.1 = High disease activity~DAS28 < 3.2 = Low disease activity~DAS28 < 2.6 = Remission"|Baseline, Month 3, Month 6, Month 9|All participants|||Participants|||Count of Participants
2612909|NCT02028169|Secondary|Percentage of Participants With American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Month 9|"A participant is an ACR20, ACR50, or ACR70 responder if the following 3 criteria for improvement from Baseline are met:~≥ 20%, ≥ 50%, or ≥ 70% improvement in tender joint count;~≥ 20%, ≥ 50%, or ≥ 70% improvement in swollen joint count; and~≥ 20%, ≥ 50%, or ≥ 70% improvement in at least 3 of the 5 following parameters:~Physician's global assessment of disease activity~Participant's global assessment of disease activity~Participant's assessment of pain~HAQ-DI~Acute phase reactant (erythrocyte sedimentation rate/C-reactive protein)."|Month 9|Participants with an assessment.|||percentage of participants|||Number
2612910|NCT02028169|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) Score Up to Month 9|The HAQ-DI is a participant-reported questionnaire. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide a total score ranging from 0 (no disability) to 3 (very severe, high-dependency disability).|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||units on a scale||Standard Deviation|Mean
2612911|NCT02028169|Primary|WPAI Questionnaire: Mean Percentage of Activity Impairment Due to PsA Up to Month 9|Activity impairment due to PsA (the extent to which PsA affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||percentage of activity impairment||Standard Deviation|Mean
2612912|NCT02028169|Primary|WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to PsA Up to Month 9|The mean percentage of OWPI due to PsA (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) +[1- Absenteeism(%)*Presenteeism(%)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||percentage of OWPI||Standard Deviation|Mean
2612913|NCT02028169|Primary|WPAI Questionnaire: Mean Percentage of Impairment While Working Due to PsA (Presenteeism) Up to Month 9|Presenteeism (the extent to which PsA decreased productivity) is presented as the mean percentage of impairment while working due to PsA, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||percentage of impairment while working||Standard Deviation|Mean
2612914|NCT02028169|Primary|Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) Up to Month 9|Absenteeism, presented as the mean percentage of work time missed due to PsA (as reported on the WPAI), and calculated as: 100*number of hours of work missed due to PsA / (number of hours of work missed due to PsA + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.|Baseline, Month 3, Month 6, Month 9|Participants with an assessment at given time point.|||percentage of work time missed||Standard Deviation|Mean
2612915|NCT02028065|Secondary|Percentage of Participants With Adjudicated Anaphylaxis|The investigator or designated clinician performed a THA in each participant at 0.5, 4 and 24 hours after each dose. The THA could also be performed at other times if possible hypersensitivity signs were observed. Each potential hypersensitivity case identified by presence of any sign or symptom in a pre-defined list of hypersensitivity signs and symptoms that were found through the THA was reviewed by an independent, blinded adjudication committee, which determined whether the referred case was a case of anaphylaxis (yes/no) using Sampson Criterion 1 - Acute onset of an illness with involvement of the skin, mucosal tissue or both, and at least one of the following: a) respiratory compromise, b) reduced blood pressure or associated symptoms of end-organ dysfunction (J Allergy Clin Immunol 2006;117:391-397). All AEs occurring in study were reviewed for terms associated with hypersensitivity or anaphylaxis, and could also result in referral to the adjudication committee for evaluation.|Up to approximately 28 days after last dose (approximately 14 weeks)|APaT - All randomized participants who received at least one dose of study treatment, with each participant included in arm corresponding to treatment actually received.|||percentage of participants||95% Confidence Interval|Number
2612932|NCT02027701|Secondary|Change From Baseline in Rasch-built Overall Disability Scale (R-ODS)|"The R-ODS is a recently published outcome measure that captures activity and social participation in subjects with Guillain-Barré Syndrome, CIDP, and monoclonal gammopathy of uncertain significance. The 24-item questionnaire covers a wide range of tasks of daily life that are each to be rated as impossible to perform, able to perform with difficulty, or easy to perform (scale of 0 - 2 points respectively). Items are sorted in order of increasing difficulty to perform, based on data from subjects with peripheral neuropathies (chronic inflammatory demyelinating polyneuropathy, Guillain-Barré Syndrome, or monoclonal gammopathy of uncertain significance) and subjects recruited at the university outpatient clinics of Rotterdam and Maastricht."|Baseline and up to 49 weeks|Total Set|||units on a scale||Full Range|Median
2613512|NCT02019979|Primary|Progress Free Survival|Progress Free Survival (PFS) is defined as the time from the date of the first dose of treatment to the earlier of the dates of first disease progression per RECIST 1.1 or death from any cause.|Time after day 1 cycle 1 to first disease progression for up to 20 months||||months||Full Range|Median
2612916|NCT02028065|Primary|Percentage of Participants With Adjudicated Symptoms of Hypersensitivity|The investigator or designated clinician performed a targeted hypersensitivity assessment (THA) in each participant at 0.5, 4 and 24 hours after each dose for each dosing period. The THA could also be performed at other times if possible hypersensitivity signs were observed. The THA included elicitation of symptoms as well as examination of the participant, covering neurologic, pulmonary, cardiovascular, gastrointestinal and dermatologic domains. Each potential hypersensitivity case identified by the presence of any sign or symptom in a pre-defined list of hypersensitivity signs and symptoms that were found through the THA was reviewed by an independent, blinded adjudication committee, which determined whether the referred case was a case of hypersensitivity (yes/no). In addition, all adverse events (AEs) occurring in study were reviewed for terms associated with hypersensitivity or anaphylaxis, and could also result in referral to the adjudication committee for evaluation.|Up to approximately 28 days after last dose (approximately 14 weeks)|APaT - All randomized participants who received at least one dose of study treatment, with each participant included in arm corresponding to treatment actually received.|||percentage of participants||95% Confidence Interval|Number
2612917|NCT02027883|Other Pre-specified|Safety Monitoring|Number of participants that were monitored for safety issues, including increased heart rate, blood pressure, decreased oximetry levels, and stable rhythm during the entire procedure.|2 hours||||participants|||Number
2612918|NCT02027883|Secondary|Factors|Determine if any pre-implant patient demographics are factors impacting T-shock success according to parameter settings.|2 hours||||participants|||Number
2612919|NCT02027883|Primary|Sustained Ventricular Fibrillation|The primary endpoint is the successful induction of sustained ventricular fibrillation.|2 hours||||participants|||Number
2612920|NCT02027844|Other Pre-specified|Postoperative Behavioral Changes|"The investigators measure negative postoperative behavioral change of children after discharge of postanesthetic care unit using posthospital behavioral questionnaires( PHBQ ) at postoperative day (POD) 1 by visiting and followed at POD 14 by phone interview.~The PHBQ consists of 27 items concerning sleep, eating, anxiety, aggressive behaviour, etc.~The subscales were: general anxiety and regression, separation anxiety, anxiety about sleep, eating disturbance, aggression towards authority, and withdrawal.~Negative behavior change was evaluated in 6 subscales categories. If more than one negative behavior change developed, the investigators calculated number of children who developed new-onset negative behavior change."|1. postoperative 2 days, 2 postoperative 14 days|If more than one negative behavior change in children developed, the investigators calculated number of the children who developed new-onset negative behavior change.|||participants|||Number
2612921|NCT02027844|Other Pre-specified|Postoperative Emergence Delirium|"The investigators measure postoperative emergence delirium of children after recovery of anesthesia using Children's Hospital of Eastern Ontario Pain(CHEOP) Scale at 20 minute in postanesthetic care unit~The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. It can be used to monitor the effectiveness of interventions for reducing the pain and discomfort.~CHEOPS pain score = SUM(points for all 6 parameters) : Cry, facila, Child verbal, Torso, Touch, legs~Interpretation:~minimum score: 4 = no pain~maximum score: 13 = the worst pain~When the highest CHEOPS score recorded at any time exceeded 10, emergence delirium was deemed to be present."|at 20 minute in postanesthetic care unit|When the highest CHEOPS score recorded at any time exceeded 10, emergence delirium was deemed to be present.|||participants|||Number
2612922|NCT02027844|Secondary|Change From Baseline Parental Anxiety at Postinduction of Anesthesia|"The investigators measure change of parental anxiety using State-Trait Anxiety Inventory (STAI)~The State-Trait Anxiety Inventory (STAI) is a psychological inventory and consists of 40 questions on a self-report basis.~The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic.~Higher scores are positively correlated with higher levels of anxiety.~Each type of anxiety has its own scale of 20 different questions that are scored.~Scores range from 20 to 80, with higher scores correlating with greater anxiety."|1. baseline: 15 minute after arrival at preoperative holding area before induction of anesthesia 2. postinduction : after induction of anesthesia||||units on a scale||Inter-Quartile Range|Median
2612923|NCT02027844|Primary|Modified Yale Preoperative Anxiety Scale Scores at Baseline, Arrival in Operating Room, and Inhalation Induction|"The investigators measure change in anxiety of children using Modified Yale Preoperative Anxiety scale (m-YPAS): Scale changes from Activities, Vocalization, Expressing emotions, State of arousal, Interaction with family members.~Each domain received a partial score based on the punctuation observed divided by the number of categories of that domain. The score of each domain is added to the others~Total scores ranged from 23.4 to 100 The scores considered cut points to determine whether a patient had/had not anxiety were 23~Without anxiety: 23.4 e 30~With anxiety: greater than 30."|1. baseline (10 minute after arrival in the preoperative holding area) 2. on arrival in the operating room, 3. during inhalational induction with sevoflurane||||units on a scale||Inter-Quartile Range|Median
2612924|NCT02027701|Secondary|Percentage of Subjects With Serious AEs||Up to 49 weeks|SDS|||percentage of subjects|||Number
2612925|NCT02027701|Secondary|Number of Serious AEs Per Infusion||Up to 49 weeks|SDS|||Adverse events per infusion|Infusions||Number
2612926|NCT02027701|Secondary|Percentage of Subjects With Causally Related AEs||Up to 49 weeks|SDS|||percentage of subjects|||Number
2612927|NCT02027701|Secondary|Number of Causally Related AEs Per Infusion||Up to 49 weeks|SDS|||Adverse events per infusion|Infusions||Number
2612928|NCT02027701|Secondary|Percentage of Subjects With AEs by Severity||Up to 49 weeks|SDS|||percentage of subjects|||Number
2612929|NCT02027701|Secondary|Number of AEs by Severity Per Infusion||Up to 49 weeks|SDS|||Adverse events per infusion|Infusions||Number
2612930|NCT02027701|Secondary|Percentage of Subjects With Adverse Events (AEs)||Up to 49 weeks|SDS|||percentage of subjects|||Number
2612931|NCT02027701|Secondary|Change From Baseline in Mean Grip Strength|The hand-held Vigorimeter from Martin (Tuttlingen, Germany) is a device that measures the strength of small muscles in the hand, ie, grip strength. The subject squeezes a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure is recorded via a rubber tube on a nanometer and expressed in kilopascal (kPa). At each assessment, the subject squeezes 3 times with each hand.|Baseline and up to 49 weeks|Total Set|||kPa||Full Range|Median
2613513|NCT02019940|Other Pre-specified|Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR)||12 weeks|||||||
2612933|NCT02027701|Secondary|Change From Baseline in Medical Research Council (MRC) Score|An adapted version of the MRC sum score as published by Kleyweg and the RMC trial group was used. With the MRC sum score, the following 8 bilateral muscle pairs were assessed, and individual muscle scores as well as the sum score documented: Shoulder abduction; Elbow flexion; Wrist extension; Index finger abduction; Hip flexion; Knee extension; Foot dorsiflexion; Great toe dorsiflexion. The MRC sum score ranges from 0 (paralysis) to 80 (normal strength) points.|Baseline and up to 49 weeks|Total Set|||units on a scale||Full Range|Median
2612934|NCT02027701|Secondary|Change From Baseline in CIDP Total Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Score|"The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 (No upper limb problems) to 5 (Inability to use either arm for any purposeful movement), and scores for leg disability range from 0 (Walking not affected) to 5 (Restricted to wheelchair, unable to stand and walk a few steps with help). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the adjusted INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant."|Baseline and up to 49 weeks|Total Set|||units on a scale||Full Range|Median
2612935|NCT02027701|Secondary|Time to First CIDP Relapse|Time to first CIDP relapse based on adjusted INCAT score, using the Kaplan-Meier estimator. Relapse is defined as an increase of at least 1 INCAT score point (except for the increase from 0 to 1 in the upper limb score only).|Up to 49 weeks|Total Set: all subjects enrolled in the study, ie, the subject’s informed consent was obtained. In the study protocol, this analysis set was referred to as the Intention-to-Treat Data Set.|||Days||95% Confidence Interval|Median
2612936|NCT02027701|Primary|Number of Adverse Events (AEs) Per Infusion||Up to 49 weeks|Safety Data Set (SDS): all subjects who received at least 1 dose of IgPro20 in this study.|||Adverse events per infusion|Infusions||Number
2612937|NCT02027623|Other Pre-specified|Change in Direct and Indirect Healthcare Costs (Estimated Costs) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase||6 months after initial intervention phase, 12 months after initial intervention phase|The exploratory economic analyses we proposed to examine direct (medication and health services use and medical equipment) and indirect (absenteeism and presenteeism) health costs are not to be conducted. The decision was based on large budget cuts that limited our ability to financially support the personnel to conduct the analyses||||||
2612938|NCT02027623|Other Pre-specified|Change in Direct and Indirect Healthcare Costs (Estimated Costs) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase||Completion of initial 6 week intervention phase, 6 months after initial intervention phase|The exploratory economic analyses we proposed to examine direct (medication and health services use and medical equipment) and indirect (absenteeism and presenteeism) health costs are not to be conducted. The decision was based on large budget cuts that limited our ability to financially support the personnel to conduct the analyses||||||
2612939|NCT02027623|Other Pre-specified|Change in Direct and Indirect Health Care Costs (Estimated Costs) From Baseline to Completion of Initial 6 Week Intervention Phase||Baseline, completion of initial 6 week intervention phase|The exploratory economic analyses we proposed to examine direct (medication and health services use and medical equipment) and indirect (absenteeism and presenteeism) health costs are not to be conducted. The decision was based on large budget cuts that limited our ability to financially support the personnel to conduct the analyses||||||
2612940|NCT02027623|Other Pre-specified|Treatment Preference Assessment Measure, Convenience Subscale (0-4 Points)|"Background/Purpose: This questionnaire is designed to provide information about a participant's treatment preferences and the participant's perceptions of four attributes of each treatment: effectiveness, acceptability, suitability/appropriateness, and convenience. The questionnaire is modified from a preference questionnaire designed by Sidani et al to reflect the treatments provided in the trial.~Procedure: The two treatment descriptions will be given in a random order to each participant.~Scoring: The four treatment attributes (effectiveness, acceptability, suitability/appropriateness, and convenience) will be rated on a 5-point Likert scale (0-4). The anchors are not at all (rating=0) and very much (rating=4)."|Baseline|Data available at this time point|||units on a scale||Standard Deviation|Mean
2612941|NCT02027623|Other Pre-specified|Treatment Preference Assessment Measure, Suitability/Appropriateness Subscale (0-4 Points)|"Background/Purpose: This questionnaire is designed to provide information about a participant's treatment preferences and the participant's perceptions of four attributes of each treatment: effectiveness, acceptability, suitability/appropriateness, and convenience. The questionnaire is modified from a preference questionnaire designed by Sidani et al to reflect the treatments provided in the trial.~Procedure: The two treatment descriptions will be given in a random order to each participant.~Scoring: The four treatment attributes (effectiveness, acceptability, suitability/appropriateness, and convenience) will be rated on a 5-point Likert scale (0-4). The anchors are not at all (rating=0) and very much (rating=4)."|Baseline||||units on a scale||Standard Deviation|Mean
2612942|NCT02027623|Other Pre-specified|Treatment Preference Assessment Measure, Acceptability Subscale (0-4 Points)|"Background/Purpose: This questionnaire is designed to provide information about a participant's treatment preferences and the participant's perceptions of four attributes of each treatment: effectiveness, acceptability, suitability/appropriateness, and convenience. The questionnaire is modified from a preference questionnaire designed by Sidani et al to reflect the treatments provided in the trial.~Procedure: The two treatment descriptions will be given in a random order to each participant.~Scoring: The four treatment attributes (effectiveness, acceptability, suitability/appropriateness, and convenience) will be rated on a 5-point Likert scale (0-4). The anchors are not at all (rating=0) and very much (rating=4)."|Baseline|Data available at this time point|||units on a scale||Standard Deviation|Mean
2612951|NCT02027623|Other Pre-specified|Adherence to Home Program (0-100%) at 6 Months After Completion of Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to provide information about how often a participant performs his treatment as it was prescribed.~Procedure: Participants will use a VAS to indicate an average percent adherence to performance of the treatment as prescribed over the past month.~Scoring: Value (percentage of treatment performed) provided by the participant on each monthly survey. Scores range from 0-100%. Higher values indicate higher adherence to treatment."|6 months after initial intervention phase|Data available at this time point|||percentage of adherence to home program||Standard Deviation|Mean
2612943|NCT02027623|Other Pre-specified|Treatment Preference Assessment Measure, Effectiveness Subscale (0-4 Points)|"Background/Purpose: This questionnaire is designed to provide information about a participant's treatment preferences and the participant's perceptions of four attributes of each treatment: effectiveness, acceptability, suitability/appropriateness, and convenience. The questionnaire is modified from a preference questionnaire designed by Sidani et al to reflect the treatments provided in the trial.~Procedure: The two treatment descriptions will be given in a random order to each participant.~Scoring: The four treatment attributes (effectiveness, acceptability, suitability/appropriateness, and convenience) will be rated on a 5-point Likert scale (0-4). The anchors are not at all (rating=0) and very much (rating=4)."|Baseline||||units on a scale||Standard Deviation|Mean
2612944|NCT02027623|Other Pre-specified|Change in Fear-Avoidance Beliefs Questionnaire Physical Activity Subscale Score (0-24 Points) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP.~Procedure: Participants will answer each question by marking the answer as indicated.~Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42."|6 months after initial intervention phase, 12 months after initial intervention phase|Data for 12 months after the initial intervention phase were not collected. The decision not to collect 12 month data was made prior to finalization of the protocol and participant enrollment.||||||
2612945|NCT02027623|Other Pre-specified|Change in Fear-Avoidance Beliefs Questionnaire Physical Activity Subscale Score (0-24 Points) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP.~Procedure: Participants will answer each question by marking the answer as indicated.~Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42."|Completion of initial 6 week intervention phase, 6 months after initial intervention phase|Data available at the time points|||score on a scale||Standard Deviation|Mean
2612946|NCT02027623|Other Pre-specified|Change in Fear-Avoidance Beliefs Questionnaire Physical Activity Subscale Score (0-24 Points) From Baseline to Completion of Initial 6 Week Intervention Phase|"Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP.~Procedure: Participants will answer each question by marking the answer as indicated.~Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42."|Baseline, completion of initial 6 week intervention phase|Data available at the time points|||score on a scale||Standard Deviation|Mean
2612947|NCT02027623|Other Pre-specified|Change in Fear-Avoidance Beliefs Questionnaire Work Subscale Score (0-42 Points) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP.~Procedure: Participants will answer each question by marking the answer as indicated.~Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42."|6 months after initial intervention phase, 12 months after initial intervention phase|Data for 12 months after the initial intervention phase were not collected. The decision not to collect 12 month data was made prior to finalization of the protocol and participant enrollment.||||||
2612948|NCT02027623|Other Pre-specified|Change in Fear-Avoidance Beliefs Questionnaire Work Subscale Score (0-42 Points) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP.~Procedure: Participants will answer each question by marking the answer as indicated.~Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42."|Completion of initial 6 week intervention phase, 6 months after initial intervention phase|Data available at the time points|||score on a scale||Standard Deviation|Mean
2612949|NCT02027623|Other Pre-specified|Change in Fear-Avoidance Beliefs Questionnaire Work Subscale Score (0-42 Points) From Baseline to Completion of Initial 6 Week Intervention Phase|"Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP.~Procedure: Participants will answer each question by marking the answer as indicated.~Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42."|Baseline, completion of initial 6 week intervention phase|Data available at the time points|||score on a scale||Standard Deviation|Mean
2612950|NCT02027623|Other Pre-specified|Adherence to Home Program (0-100%) at 12 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to provide information about how often a participant performs his treatment as it was prescribed.~Procedure: Participants will use a VAS to indicate an average percent adherence to performance of the treatment as prescribed over the past month.~Scoring: Value (percentage of treatment performed) provided by the participant on each monthly survey. Scores range from 0-100%. Higher values indicate higher adherence to treatment."|12 months after initial intervention phase|Data available at this time point|||percentage of adherence to home program||Standard Deviation|Mean
2612952|NCT02027623|Other Pre-specified|Adherence to Home Program (0-100%) at Completion of Initial 6 Week Intervention Phase|"Background/Purpose: This questionnaire is designed to provide information about how often a participant performs his treatment as it was prescribed.~Procedure: Participants will use a VAS to indicate for each day the percentage of the treatment they were able to perform as prescribed. At each clinic visit the therapist will ask the participant to provide an estimate of the average percentage of the treatment he was able to perform as prescribed in the interval of time between 2 clinic visits.~Scoring: Average adherence is calculated by averaging the participants' daily adherence. Scores range from 0-100%. Higher values indicate higher adherence to treatment."|completion of initial 6 week intervention phase|Data available at this time point|||percentage of adherence to home program||Standard Deviation|Mean
2612953|NCT02027623|Secondary|Change in Kinematics During Functional Activities (Degrees) From Completion of Initial 6 Week Intervention Phase to 6 Months After Intervention Phase||Completion of initial 6 week intervention phase, 6 months after initial intervention phase||2020-04-30|04/2020||||
2612954|NCT02027623|Secondary|Change in Kinematics During Functional Activities (Degrees) From Baseline to Completion of Initial 6 Week Intervention Phase||Baseline, completion of initial 6 week intervention phase||2020-04-30|04/2020||||
2612955|NCT02027623|Secondary|Satisfaction With Care (15-75 Points)|"Background/Purpose: This questionnaire assesses information about how satisfied a participant feels with the physical therapist and treatment he was provided.~Procedure: Participants will answer each question by marking the answer as indicated. They may only check off one answer per item.~Scoring: Each question is ranked on a 5-point Likert scale. All scores are 1-5, with questions 1, 3, 4, 8, 9, 10 and 13 reverse scored (5-1). The total score is the sum of all of the answers (15-75) with higher scores indicating more satisfaction with care."|Completion of initial 6 week intervention phase|Data available at the time points|||score on a scale||Standard Deviation|Mean
2612956|NCT02027623|Secondary|Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to provide general information on the use of additional treatments for a participant's LBP.~Health Professional Care Seeking Procedure: Participants will answer each question by marking yes or no for a list of other healthcare professionals they are seeing for treatment of their LBP.~Equipment Use Procedure: Participants will answer each question by marking yes or no for a list of equipment they are using to treat their LBP.~Scoring: Reported as the number of participants seeking care from health professionals for LBP or using equipment for LBP."|6 months after initial intervention phase, 12 months after initial intervention phase|Data available at the time points|||Participants|||Count of Participants
2612957|NCT02027623|Secondary|Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to provide general information on the use of additional treatments for a participant's LBP.~Health Professional Care Seeking Procedure: Participants will answer each question by marking yes or no for a list of other healthcare professionals they are seeing for treatment of their LBP.~Equipment Use Procedure: Participants will answer each question by marking yes or no for a list of equipment they are using to treat their LBP.~Scoring: Reported as the number of participants seeking care from health professionals for LBP or using equipment for LBP."|Completion of initial 6 week intervention phase, 6 months after initial intervention phase|Data available at the time points|||Participants|||Count of Participants
2612958|NCT02027623|Secondary|Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From Baseline to Completion of Initial 6 Week Intervention Phase|"Background/Purpose: This questionnaire is designed to provide general information on the use of additional treatments for a participant's LBP.~Health Professional Care Seeking Procedure: Participants will answer each question by marking yes or no for a list of other healthcare professionals they are seeing for treatment of their LBP.~Equipment Use Procedure: Participants will answer each question by marking yes or no for a list of equipment they are using to treat their LBP.~Scoring: Reported as the number of participants seeking care from health professionals for LBP or using equipment for LBP."|Baseline, completion of initial 6 week intervention phase|Data available at the time points|||Participants|||Count of Participants
2612959|NCT02027623|Secondary|Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities.~Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can.~Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health."|6 months after initial intervention phase, 12 months after initial intervention phase|Data available at the time points|||T-scores||Standard Deviation|Mean
2612960|NCT02027623|Secondary|Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities.~Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can.~Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health."|Completion of initial 6 week intervention phase, 6 months after initial intervention phase|Data available at the time points|||T-scores||Standard Deviation|Mean
2613514|NCT02019940|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)||12 weeks|||||||
2612961|NCT02027623|Secondary|Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From Baseline to Completion of Initial 6 Week Intervention Phase|"Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities.~Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can.~Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health."|Baseline, completion of initial 6 week intervention phase|Data available at the time points|||T-scores||Standard Deviation|Mean
2612962|NCT02027623|Secondary|Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities.~Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can.~Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health."|6 months after initial intervention phase, 12 months after initial intervention phase|Data available at the time points|||T-scores||Standard Deviation|Mean
2612963|NCT02027623|Secondary|Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities.~Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can.~Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health."|Completion of initial 6 week intervention phase, 6 months after initial intervention phase|Data available at the time points|||T-scores||Standard Deviation|Mean
2612964|NCT02027623|Secondary|Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From Baseline to Completion of Initial 6 Week Intervention Phase|"Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities.~Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can.~Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health."|Baseline, completion of initial 6 week intervention phase|Data available at the time points|||T-scores||Standard Deviation|Mean
2612965|NCT02027623|Secondary|Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to assess how a participant's LBP affected his participation in usual activities and the impact of LBP on his ability to do his job over the past 4 weeks.~Scoring: A Work Impairment Score (WIS) is calculated as the sum of answers on the questions regarding how LBP has affected job ability over the past 4 weeks. Each of the WIS questions is ranked on a 5-point Likert scale. All scores are 1-5, with questions 2, 5, 6, 8, and 10 reverse scored (5-1). The score ranges from 10-50 with 50 indicating the highest degree of impairment."|6 months after initial intervention phase, 12 months after initial intervention phase|Data available at the time points|||score on a scale||Standard Deviation|Mean
2612966|NCT02027623|Secondary|Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to assess how a participant's LBP affected his participation in usual activities and the impact of LBP on his ability to do his job over the past 4 weeks.~Scoring: A Work Impairment Score (WIS) is calculated as the sum of answers on the questions regarding how LBP has affected job ability over the past 4 weeks. Each of the WIS questions is ranked on a 5-point Likert scale. All scores are 1-5, with questions 2, 5, 6, 8, and 10 reverse scored (5-1). The score ranges from 10-50 with 50 indicating the highest degree of impairment."|Completion of initial 6 week intervention phase, 6 months after initial intervention phase|Data available at the time points|||score on a scale||Standard Deviation|Mean
2612967|NCT02027623|Secondary|Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From Baseline to Completion of Initial 6 Week Intervention Phase|"Background/Purpose: This questionnaire is designed to assess how a participant's LBP affected his participation in usual activities and the impact of LBP on his ability to do his job over the past 4 weeks.~Scoring: A Work Impairment Score (WIS) is calculated as the sum of answers on the questions regarding how LBP has affected job ability over the past 4 weeks. Each of the WIS questions is ranked on a 5-point Likert scale. All scores are 1-5, with questions 2, 5, 6, 8, and 10 reverse scored (5-1). The score ranges from 10-50 with 50 indicating the highest degree of impairment."|Baseline, completion of initial 6 week intervention phase|Data available at the time points|||score on a scale||Standard Deviation|Mean
2613515|NCT02019940|Secondary|Clinical Global Impressions Scale||12 weeks|||||||
2612968|NCT02027623|Secondary|Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to assess the number of days a participant has been kept from his usual activities (work, school or housework) because of LBP.~Procedure: Participants will answer each question by marking the answer as indicated.~Scoring: Reported as the number of participants who reported absenteeism from usual activities over the past 4 weeks."|6 months after initial intervention phase, 12 months after initial intervention phase|Data available at the time points|||Participants|||Count of Participants
2612969|NCT02027623|Secondary|Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to assess the number of days a participant has been kept from his usual activities (work, school or housework) because of LBP.~Procedure: Participants will answer each question by marking the answer as indicated.~Scoring: Reported as the number of participants who reported absenteeism from usual activities over the past 4 weeks."|Completion of initial 6 week intervention phase, 6 months after initial intervention phase|Data available at the time points|||Participants|||Count of Participants
2612970|NCT02027623|Secondary|Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From Baseline to Completion of Initial 6 Week Intervention Phase|"Background/Purpose: This questionnaire is designed to assess the number of days a participant has been kept from his usual activities (work, school or housework) because of LBP.~Procedure: Participants will answer each question by marking the answer as indicated.~Scoring: Reported as the number of participants who reported absenteeism from usual activities over the past 4 weeks."|Baseline, completion of initial 6 week intervention phase|Data available at the time points|||Participants|||Count of Participants
2612971|NCT02027623|Secondary|Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From 6 Months After Completion of Initial Intervention Phase to 12 Months After Completion of Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to provide general information on the use of medication for a participant's LBP.~Procedure: Participants will answer each question by marking if they are taking non-prescription medication and prescription medication for their LBP. Reported as number of participants currently using medication for LBP."|6 months after initial intervention phase, 12 months after initial intervention phase|Data available at the time points|||Participants|||Count of Participants
2612972|NCT02027623|Secondary|Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to provide general information on the use of medication for a participant's LBP.~Procedure: Participants will answer each question by marking if they are taking non-prescription medication and prescription medication for their LBP. Reported as number of participants currently using medication for LBP."|Completion of initial 6 week intervention phase, 6 months after initial intervention phase|Data available at the time points|||Participants|||Count of Participants
2612973|NCT02027623|Secondary|Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From Baseline to Completion of Initial 6 Week Intervention Phase|"Background/Purpose: This questionnaire is designed to provide general information on the use of medication for a participant's LBP.~Procedure: Participants will answer each question by marking if they are taking non-prescription medication and prescription medication for their LBP. Reported as number of participants currently using medication for LBP."|Baseline, completion of initial 6 week intervention phase|Data available at the time points|||Participants|||Count of Participants
2612974|NCT02027623|Secondary|Change in Number of Acute Flare-ups of Low Back Pain (#) in Past 6 Months, From 6 Months After the Initial Intervention Phase to 12 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to give the therapist information about the history of a participant's LBP flare-ups in the past 6 months.~Definition: A flare-up is an increase in symptoms of at least 2 points on the NRS above a person's typical low back pain and lasts for at least 2 consecutive days Procedure: Participants will fill in information on how many acute flare-ups they have had over the past 6 months.~Scoring: The score will be the number the participant provides for the number of acute flare-ups over the last 6 months."|6 months after initial intervention phase, 12 months after initial intervention phase|Data available at the time points|||acute flare-ups||Standard Deviation|Mean
2612975|NCT02027623|Secondary|Change in Number of Acute Flare-ups of Low Back Pain (#) in Past 6 Months, From Baseline to 6 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to give the therapist information about the history of a participant's LBP flare-ups in the past 6 months.~Definition: A flare-up is an increase in symptoms of at least 2 points on the NRS above a person's typical low back pain and lasts for at least 2 consecutive days Procedure: Participants will fill in information on how many acute flare-ups they have had over the past 6 months.~Scoring: The score will be the number the participant provides for the number of acute flare-ups over the last 6 months."|Baseline, 6 months after initial intervention phase|Data available at the time points|||acute flare-ups||Standard Deviation|Mean
2612976|NCT02027623|Secondary|Change in Numeric Pain Rating Scale (0-10) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to give the therapist information on the intensity of a participant's LBP symptoms.~Procedure: Participants will rate their LBP symptoms on a numeric scale of 0-10 where 0 represents no symptoms and 10 represents symptoms as bad as can be. They will rate their average symptoms over the prior 7 days, and worst symptoms over the prior 7 days.~Scoring: The score for each item is the rating the participant provides for each symptom category (average and worst)."|6 months after initial intervention phase, 12 months after initial intervention phase|Data available at the time points|||units on a scale||Standard Deviation|Mean
2613007|NCT02027376|Secondary|Docetaxel Clearance on Cycle 1 and Cycle 2 (Pharmacokinetics (PK))|PK sampling of docetaxel was performed on Day 1 of Cycle 1 and 2 of treatment and docetaxel concentrations. Blood samples were collected into ethylenediaminetetraacetic acid (EDTA) K3 tubes and after plasma separation by centrifugation were stored at -70 degrees Celsius until analysis.|Cycles 1 and 2|At LDE225 600 mg, one patient was discontinued after first cycle.|||L/h||Standard Deviation|Mean
2613516|NCT02019940|Secondary|Post-Traumatic Stress Disorder Checklist (PCL)||12 weeks|||||||
2612977|NCT02027623|Secondary|Change in Numeric Pain Rating Scale (0-10) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase|"Background/Purpose: This questionnaire is designed to give the therapist information on the intensity of a participant's LBP symptoms.~Procedure: Participants will rate their LBP symptoms on a numeric scale of 0-10 where 0 represents no symptoms and 10 represents symptoms as bad as can be. They will rate their average symptoms over the prior 7 days, and worst symptoms over the prior 7 days.~Scoring: The score for each item is the rating the participant provides for each symptom category (average and worst)."|Completion of initial 6 week intervention phase, 6 months after initial intervention phase|Data available at the time points|||units on a scale||Standard Deviation|Mean
2612978|NCT02027623|Secondary|Change in Numeric Pain Rating Scale (0-10) From Baseline to Completion of Initial 6 Week Intervention Phase|"Background/Purpose: This questionnaire is designed to give the therapist information on the intensity of a participant's LBP symptoms.~Procedure: Participants will rate their LBP symptoms on a numeric scale of 0-10 where 0 represents no symptoms and 10 represents symptoms as bad as can be. They will rate their average symptoms over the prior 7 days, and worst symptoms over the prior 7 days.~Scoring: The score for each item is the rating the participant provides for each symptom category (average and worst)."|Baseline, completion of initial 6 week intervention phase|Data available at the time points|||units on a scale||Standard Deviation|Mean
2612979|NCT02027623|Primary|Change in Modified Oswestry Disability Questionnaire (0-100%) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase|"Background/Purpose: The 10-item Modified Oswestry Disability Questionnaire is a disease-specific measure that provides an index of a participant's perceived low back pain-related functional limitation.~Procedure: Participants will answer each of the 10 questions by placing a mark in the one box that best describes his current condition. Since a participant may feel that 2 of the statements describe his condition, he is instructed to mark only the box that most closely describes his current condition.~Scoring: Each item is given a value from 0-5. The total score is the sum of all questions divided by 50, multiplied by 100 to get a percent. 100 represents the highest level of limitation."|6 months after initial intervention phase, 12 months after initial intervention phase|Data available at the time points|||score on a scale||Standard Deviation|Mean
2612980|NCT02027623|Primary|Change in Modified Oswestry Disability Questionnaire (0-100%) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase|"Background/Purpose: The 10-item Modified Oswestry Disability Questionnaire is a disease-specific measure that provides an index of a participant's perceived low back pain-related functional limitation.~Procedure: Participants will answer each of the 10 questions by placing a mark in the one box that best describes his current condition. Since a participant may feel that 2 of the statements describe his condition, he is instructed to mark only the box that most closely describes his current condition.~Scoring: Each item is given a value from 0-5. The total score is the sum of all questions divided by 50, multiplied by 100 to get a percent. 100 represents the highest level of limitation."|Completion of initial 6 week intervention phase, 6 months after initial intervention phase|Data available at the time points|||score on a scale||Standard Deviation|Mean
2612981|NCT02027623|Primary|Change in Modified Oswestry Disability Questionnaire (0-100%) From Baseline to Completion of Initial 6 Week Intervention Phase|"Background/Purpose: The 10-item Modified Oswestry Disability Questionnaire is a disease-specific measure that provides an index of a participant's perceived low back pain-related functional limitation.~Procedure: Participants will answer each of the 10 questions by placing a mark in the one box that best describes his current condition. Since a participant may feel that 2 of the statements describe his condition, he is instructed to mark only the box that most closely describes his current condition.~Scoring: Each item is given a value from 0-5. The total score is the sum of all questions divided by 50, multiplied by 100 to get a percent. 100 represents the highest level of limitation."|Baseline, completion of initial 6 week intervention phase|Data available at the time points|||score on a scale||Standard Deviation|Mean
2612982|NCT02027558|Primary|PAP Adherence|Number of nights positive airway pressure (PAP) was used >=4 hours during the first 90 days measured by remote monitoring. Scores range from 0 to 90 days. Higher scores indicate better outcome.|Three months after randomization||||number of nights||Standard Error|Mean
2612983|NCT02027558|Primary|Sleep Efficiency From Wrist Actigraphy|Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of wrist actigraphy. Scores range from 0 to 100 percent. Higher scores indicate better outcome.|Three months after randomization||||percentage of time||Standard Error|Mean
2612984|NCT02027558|Primary|Sleep Efficiency From Sleep Diary|Sleep efficiency (mean percent time asleep while in bed) will be calculated from 7 days of self-reported sleep diary. Scores range from 0 to 100 percent. Higher scores indicate better outcome.|Three months after randomization||||percentage of time||Standard Error|Mean
2612985|NCT02027558|Primary|Wake After Sleep Onset From Sleep Diary|Wake after sleep onset (minutes awake from sleep onset to get up time) will be calculated from 7 days of self-reported sleep diary. Minimum value is 0 minutes. Maximum possible value is 1,440 minutes (24 hours). Higher scores indicate worse outcome.|Three months after randomization||||minutes||Standard Error|Mean
2612986|NCT02027558|Primary|Sleep Onset Latency From Sleep Diary|Sleep onset latency (minutes to fall asleep) will be calculated from 7 days of self-reported sleep diary. Minimum value is 0 minutes. Maximum possible value is 1,440 minutes (24 hours). Higher scores indicate worse outcome.|Three months after randomization||||minutes||Standard Error|Mean
2612987|NCT02027558|Primary|Sleep Quality|Total score on the Pittsburgh Sleep Quality Index will be used as a measure of sleep quality. Scores range from 0 to 21. Higher scores indicate worse outcome.|Three months after randomization||||score on a scale||Standard Error|Mean
2612988|NCT02027545|Secondary|Number of Participants With CRC Screening Utilized|Screening test completion was collected through manual review of electronic medical records.|6 months||||Participants|||Count of Participants
2613020|NCT02027025|Secondary|Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Spasm Frequency|"Spasm frequency was assessed using following 4-point scale as follows:~Minimum score of 0 (better outcome))=no spasm Maximum score of 4 (worst outcome)=Spasms occurring more than 10 times per hour"|Baseline, Day 24|"Intent to treat population:~SPARC 1103 low dose, N= 47; SPARC1103 High dose, N=42; and Placebo, N=46"|||score on a scale||Standard Error|Least Squares Mean
2612989|NCT02027545|Secondary|Concordance Between Screening Orders and Screening Benefit|"Defined as the degree to which screening orders align with expected screening benefit, such that individuals with low screening benefit receive screening orders at a lower rate than those with high screening benefit.~We hypothesized that Veterans randomized to the intervention (decision aid) would receive screening orders that were more concordant with screening benefit than those randomized to the control. The expected benefit of screening (reduction in CRC incidence) was calculated using the MISCAN-Colon model. For a given patient, this value was a function of age, gender, health status, and prior screening history. The regression analysis included screening orders as the dependent variable, and, study arm, expected benefit, and an interaction term between study arm and expected benefit as the independent variables. The p-value reported is for the interaction term."|2 weeks||||Participants|||Count of Participants
2612990|NCT02027545|Primary|Number of Participants With CRC Screening Ordered|The primary dependent variable in the analysis was whether screening was ordered within two weeks after the clinic visit (dichotomous). Screening orders were determined by manual record review of electronic health records.|2 weeks||||Participants|||Count of Participants
2612991|NCT02027428|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs) Over the Entire Study|TEAE over entire study is defined as any adverse event (AE) with an onset on or after Day 1 of treatment for the Induction part, and before the treatment discontinuation date plus 28 days, or any serious AE which occurred thereafter but was determined to be related to any study drug by the investigator. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life threatening, Grade 5 = Death. Relation to study drug was determined by the investigator.|From Day 1 up to approximately Week 167 (maximum treatment length plus 28 days)|Safety population of participants randomized into Maintenance, inclusive of both the Induction and Maintenance parts|||Participants|||Count of Participants
2612992|NCT02027428|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs) in the Induction Part|TEAE in the Induction part is defined as any adverse event (AE) with an onset on or after Day 1 of treatment for the Induction part, and on or before the day of randomization for subjects who entered into the Maintenance part, or, for subjects who did not enter into the Maintenance part, before the treatment discontinuation date plus 28 days or any serious AE which occurred thereafter but was determined to be related to any study drug by the investigator. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild, Grade 2 = Moderate Grade, 3 = Severe Grade, 4 = Life threatening, Grade 5 = Death. Relation to study drug was determined by the investigator.|Day 1 of Induction up Week 23 (maximum treatment in Induction plus 4 weeks if not continuing into Maintenance)|Safety population of participants treated during Induction|||Participants|||Count of Participants
2612993|NCT02027428|Secondary|Kaplan-Meier Estimate for Duration of Response Over the Entire Study|Duration of overall response was measured from the time criteria were first met for CR/PR until the first date the recurrent or progressive disease (PD) was radiologically documented. Participants who did not have PD after the response were censored on the date of last tumor assessment. If a participant died before PD, the participant was censored on the date of death.|Between Day 1 of the Induction Part through to the date of disease progression or death; up to the data cut-off date of 15 September 2017 (longest treatment duration is 162.9 weeks )|ITT population of participants randomized to Maintenance and had a confirmed partial or complete response.|||months||95% Confidence Interval|Median
2612994|NCT02027428|Secondary|Time to Confirmed Response During Induction and Over the Entire Study|Time to confirmed complete or partial response (CR/PR) is defined as the time from day 1 of treatment in Induction to the first occurrence of confirmed CR/PR. Two timeframes are offered: - Time to confirmed response within the Induction timeframe. - Time to Confirmed Response Over the Entire Study, i.e. the time from Day 1 of treatment in Induction to the first occurrence of confirmed CR/PR any time during the study. Only participants with a confirmed CR or PR are included in this summary.|Induction is from Day 1 to a maximum treatment time of 19 weeks; Entire Study from Day 1 Induction through Maintenance up to PD or the data cut-off date of 15 Sept 2017 has a maximum treatment duration of 162.9 weeks.|ITT population of participants who had a response. Induction includes the ITT population of participants treated during Induction who had a response. Induction+Maintenance includes the ITT population of participants randomized to Maintenance who had a response.|||months||Full Range|Median
2612995|NCT02027428|Secondary|Percentage of Participants Who Achieved Disease Control (Disease Control Rate) by Investigator Assessment During Induction and Over the Entire Study|Disease control rate was defined as the percentage of participants who had radiologic CR, PR or SD for >= 6 weeks according to RECIST 1.1 criteria as determined by the investigator. Only participants with a confirmed CR/PR are included in this summary. Two timeframes are offered: - Time to confirmed response within the Induction timeframe. - Time to Confirmed Response Over the Entire Study, i.e. the time from Day 1 of treatment in Induction to the first occurrence of confirmed CR/PR any time during the study. RECIST 1.1 Definition: - CR- disappearance of all target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to < 10 mm. - PR- at least a 30% decrease in the sum of diameters of target lesions from baseline; - SD- neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for PD. The 95% CI was calculated using Clopper-Pearson method.|Induction is from Day 1 to a maximum treatment time of 19 weeks; Entire Study from Day 1 Induction through Maintenance up to PD or the data cut-off date of 15 Sept 2017 has a maximum treatment duration of 162.9 weeks.|Induction includes the ITT population of participants treated during Induction. Entire Study includes the entire experience of the ITT population of participants randomized to Maintenance.|||percentage of participants||95% Confidence Interval|Number
2613021|NCT02027025|Secondary|Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Night Time Awakening Score|"Nighttime awakening score was assessed as follows:~The subject was asked the following question on the morning of Day 24: How many times did you wake up last night due to spasticity? Score range from 0 (better score) to infinity (worse score)"|Baseline, Day 24|Intent to treat population: SPARC 1103 low dose, N=47; SPARC 1103 high dose, N=42; and Placebo N=46.|||Awakenings||Standard Error|Least Squares Mean
2614239|NCT02013674|Secondary|Number of Clinically Significant of Abnormal Lab Values.|Clinical significance of abnormal lab values will be assessed by treating physician|12 months|Data were not available to perform the statistical analyses as described in the protocol for this outcome.||||||
2612996|NCT02027428|Secondary|Percentage of Participants Who Achieved a Confirmed Overall Response of Complete Response or Partial Response (Overall Response Rate) In Maintenance Beyond the Response in Induction|Overall response in the Maintenance was defined as the percentage of participants who showed an improvement in best overall response from stable disease (SD) or partial response (PR) during Induction to a Complete Response (CR) or PR during Maintenance according to RECIST 1.1 criteria and confirmed in no less than 28 days. Evaluation takes as reference the lesion measurement or status at the last tumor assessment before randomization to Maintenance. The 95% CI was calculated using Clopper-Pearson method. RECIST 1.1 Definition: - Complete response-disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. - Partial response-at least a 30% decrease in the sum of diameters of target lesions from baseline. - Stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease.|Induction maximum treatment is 19 weeks. Maintenance maximum treatment is 150 weeks.|Intent to treat population of participants randomized to Maintenance|||percentage of participants||95% Confidence Interval|Number
2612997|NCT02027428|Secondary|Kaplan-Meier Estimate of Overall Survival (OS) Over Entire Study|Overall survival was defined as the time in months from Day 1 of treatment for the Induction part to death from any cause. Subjects who were alive at the time of analysis had their OS censored at the date or last contact or clinical cut-off (15 Sep 2017), whichever was earlier. The last contact date was the date of the last record in the database, or if the subject was lost to follow-up, the last known date that the subject was alive.|Between Day 1 of treatment in the Induction Part to death from any cause up to date of 15 September 2017; maximum treatment duration on study was 162.9 weeks.|ITT Population of participants randomized to Maintenance|||months||95% Confidence Interval|Median
2612998|NCT02027428|Secondary|Kaplan-Meier Estimate of Progression-Free Survival (PFS) Over Entire Study|PFS was defined as the time in months from Day 1 of treatment for the Induction part to the date of disease progression according to RECIST 1.1 criteria (documented by CT-scan, not including symptomatic deterioration) or death (any cause) on or prior to the clinical cut-off date (15 Sep 2017), whichever occurred earlier. RECIST 1.1 Definition: - Progressive Disease (PD) - At least a 20% increase in the sum of diameters of target lesions from nadir; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of new lesions is also considered progression.|Between Day 1 of the Induction Part through to the date of disease progression or death; up to the data cut-off date of 15 September 2017; longest treatment duration is 162.9 weeks.|Intent to treat population of participants randomized to Maintenance|||months||95% Confidence Interval|Median
2612999|NCT02027428|Secondary|Percentage of Participants Who Achieved a Confirmed Overall Response of Complete Response or Partial Response (Overall Response Rate) Over Entire Study|Overall response was defined as the percentage of participants with a confirmed assessment of complete response (CR) or partial response (PR) according to RECIST 1.1 criteria and confirmed in no less than 28 days. The 95% confidence interval (CI) was calculated using Clopper-Pearson method. RECIST 1.1 Definition: - Complete response-disappearance of all target lesions; any pathological lymph nodes (whether target or non target) must have reduction in short axis to < 10 mm. - Partial response-at least a 30% decrease in the sum of diameters of target lesions from baseline.|Day 1 of treatment in the Induction Part and subsequent anticancer therapy, death or discontinuation up to the data cut-off date of 15 Sept 2017; longest treatment duration is 162.9 weeks.|Intent to treat population of participants randomized to Maintenance|||percentage of participants||95% Confidence Interval|Number
2613000|NCT02027428|Secondary|Kaplan-Meier Estimate of Overall Survival (OS) From Randomization Into Maintenance|Overall survival was defined as the duration in months between randomization and death from any cause. Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off (15 Sept 2017), whichever was earlier. The last contact date was the date of the last record in the database, or if the subject was lost to follow-up, the last known date that the subject was alive.|From the date of randomization to death from any cause; up to 15 September 2017 (up to 34.76 months)|Intent to treat population of participants randomized to Maintenance|||months||95% Confidence Interval|Median
2613001|NCT02027428|Primary|Kaplan-Meier Estimate of Progression-Free Survival (PFS) From Randomization Into Maintenance|Progression-free survival is defined as the time in months from the date of randomization to the date of disease progression based on the investigator's assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by computerized axial tomography [CT scan], not including symptomatic deterioration) or death (any cause) on or prior to the clinical cut-off date of September 15, 2017. RECIST 1.1 Definition: - Complete response (CR) -disappearance of all target lesions; - Partial response (PR) -at least a 30% decrease in the sum of diameters of target lesions from baseline - Stable disease (SD) -neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase of lesions to qualify for progressive disease (PD) - Progressive Disease (PD) - At least a 20% increase in the sum of diameters of target lesions from nadir, and/or the appearance of new lesions.|From the date of randomization to the date of disease progression or death of any cause; up to the data cut-off date of 15 September 2017 (up to 27.6 months)|Intent to treat (ITT) population of participants randomized to Maintenance. The ITT population in the Maintenance part included all randomized subjects regardless of whether the subject received any study drug or had any efficacy assessments collected.|||months||95% Confidence Interval|Median
2613002|NCT02027402|Secondary|Postoperative Pain Score|Postoperative pain was estimated using the visual analog scale (VAS) from 0 (no pain) to 10 (worst pain imaginable) at 6, 24, and 48 hours after the operation.|6hr after operation - 24hr after operation - 48hr after operation||||units on a scale||Standard Deviation|Mean
2613003|NCT02027402|Secondary|Postoperative Hospital Stay||2weeks||||day||Standard Deviation|Mean
2613004|NCT02027402|Secondary|Operative Time||1day||||minutes||Standard Deviation|Mean
2613005|NCT02027402|Primary|Complication|complication is subhepatic fluid collection with abscess or subhepatic hematoma or bile leakage.|2 weeks||||participants|||Number
2613006|NCT02027376|Secondary|Objective Response Rate (ORR)|Tumor response was assessed using RECIST 1.1 criteria. The best response across all treatment was recorded. ORR is defined as the percentage of patients with a complete or partial response out of the patients who had measurable disease at baseline.|Through study treatment, an average of 2 months||||Participants|||Count of Participants
2613008|NCT02027376|Secondary|LDE225 (Sonidegib) Trough Concentration (Pharmacokinetics (PK))|To evaluate the effect of LDE225 on the docetaxel PK, the main pharmacokinetic parameters of docetaxel were estimated on Day 1 of Cycles 1 and 2 of treatment, and compared between them. PK parameters were estimated by non-compartmental approach using Phoenix® WinNonlin® software (version 7.0). In the case of the effect of docetaxel on the LDE225 PK, since patients were always under both drugs at all the assessed PK profiles, the trough LDE225 concentrations obtained in our study were compared with those simulated from a previous developed PK model from LDE225 given as monotherapy. Therefore, a population PK model of LDE225 reported in the literature and developed in healthy subjects and patients with advanced solid tumors was implemented in NONMEN version 7.3 program and Monte-Carlo simulations of LDE225 concentrations after the same doses than those of our study, were performed.|Up to cycle 2|At LDE225 600 mg, one patient was discontinued after first cycle.|||mg/L||Standard Deviation|Mean
2613009|NCT02027376|Secondary|Time To Progression (TTP)|Tumor assessments were performed until disease progression in order to evaluate the TTP. TTP is defined as the time from the date of the first dose to the first date of objectively determined progressive disease. For patients not known to have objectively-determined progressive disease, TTP will be censored at the date of the last objective progression-free assessment. For patients who receive subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression, TTP will be censored at the date of last objective progression-free assessment prior to the initiation of postdiscontinuation systemic anticancer therapy.|Through study treatment, an average of 2 months||||days||95% Confidence Interval|Median
2613010|NCT02027376|Secondary|Changes in QT/QTc From Baseline and Cycle 3 ECG Values.|The QTc intervals have been characterized by comparing QTc at baseline (QTc interval measured in milliseconds (msec) by Fridericia's formula) and at cycle 3 pre-dose, 1 hour post-dose, 2 hours post-dose, 4 hours post-dose and 6 hours post-dose.|From baseline to cycle 3|Only 6 patients received cycle 3. Results are shown from the predose, at 1 hour and 2 hours post-dose for 6 patients and at 4 hours and 6 hours post-dose for 5 patients.|||milliseconds||95% Confidence Interval|Mean
2613011|NCT02027376|Secondary|The Number of Participants Who Experienced Adverse Events (AE)|Safety was assessed by standard clinical and laboratory tests [vital signs including blood pressure, pulse and body temperature, triplicate 12-lead ECGs at screening and on day 1 of cycle 3, blood tests including hematology (hemoglobin, platelets count, red blood cells (RBC), white blood cells (WBC) with differential count and serum chemistry (serum creatinine, total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP), creatine phosphokinase (CPK))]. Adverse events grade were defined by the NCI CTCAE v4.0.|Through study treatment, an average of 2 months||||number of participants with AE|||Number
2613012|NCT02027376|Primary|Recommended Phase II Dose (RP2D) of LDE225 (Sonidegib) in Combination With Docetaxel|The RP2D was decided by the investigators taken into consideration the information obtained in the study and based on the MTD. To define the RP2D, information about toxicity observed during the full treatment were taken into consideration (relative dose intensity and toxicity observed).|Through study treatment, an average of 2 months||||mg|||Number
2613013|NCT02027376|Primary|Maximum Tolerated Dose (MTD) of LDE225 (Sonidegib) in Combination With Docetaxel|MTD was determined by testing increasing doses of LDE225 on dose escalation cohorts 1 to 6 patients. MTD reflects the highest dose tested in which a DLT is experienced by 0 out of 3 or 1 out of 6 patients among the dose levels.|Through study treatment, an average of 2 months|Of the twelve patients included on the study, no Dose Limiting Toxicities (DLTs) were observed at any dose level.|||mg|||Number
2613014|NCT02027376|Primary|Incidence Rate of DLT Within the First Two Cycles of LDE225 (Sonidegib) in Combination With Docetaxel|DLT was defined as the occurrence of any of the following adverse events or abnormal laboratory values (graded according to the NCI-CTCAE version 4.0) assessed as possibly, probably or definitively related to study drugs, occurring within the first two cycles of treatment: Neutropenia grade 4 lasting more than one week, febrile neutropenia, thrombocytopenia grade 3 with bleeding more than grade 2, thrombocytopenia grade 4, Increased plasma creatinine phosphokinase (CK) grade 3-4, any non-hematologic grade 4 toxicity, or grade 3 toxicity except nausea and vomiting, Grade 2 GI toxicity (except nausea and vomiting) lasting more than 2 weeks, Inability to resume dosing for cycles 2 or 3 at the current dose level within 14 days, due to treatment-related toxicity. Dose reductions in cycles 1 and 2 will be considered a DLT|Up to cycle 2||||Participants|||Count of Participants
2613015|NCT02027311|Secondary|Event of Hypoxia|Hypoxia defined as peripheral blood oxygen saturation measured by pulse oxymeter < 90%|Every 5min in Preoperative, intraoperative phase and 15 min in Recovery phase||||Hypoxia events|||Number
2613016|NCT02027311|Primary|Number of Intervention|The frequency of intervention which was defined as any restraint of the patient's head, arms, or legs if they became agitated, or if patient movement was not controlled with verbal instruction from the endoscopist during the whole intraoperative phases.|Throughout the whole ERCP procedure||||Number of intervention||Standard Deviation|Mean
2613017|NCT02027272|Primary|Eclampsia and Posterior Reversible Encephalopathy Syndrome (PRES): Arandomized Clinical Trial Evaluating Corticosteroid Efficacy to Augment Standard Therapy and Shorten Recovery|To learn if giving IV dexamethasone to eclamptic women with PRES will accelerate normalization of CNS function.|36 months|Logistic hurdles caused to stop the study after the first participant and not proceed further. No analysis was undertaken.||||||
2613018|NCT02027025|Secondary|Subject Global Impression of Severity of Spasticity|"The subject was asked Overall, how would you rate the severity of your spasticity over the past 24 hours?~The 7-point scale for Subject's global impression of severity assessment is as follows:~minimum score of 1 = normal, no spasticity maximum score of 7 (worst outcome)= worst spasticity imaginable"|Baseline, Day 24|Intent to treat population: SPARC1103 low dose, N=47; SPARC1103 high dose, N=42; and Placebo, N=46|||Participants|||Count of Participants
2613019|NCT02027025|Secondary|Clinical Global Impression of Change Results at 24 Hours Post Dose on Day 24|"The clinician (other than the one performing the Modified Ashworth Scale assessment) rated his/her overall (global) impression of change in spasticity using the 7-point scale shown below:~Minimum score of 1 (better outcome) = very much improved Maximum score of 7 (very much worse) = very much worse"|Baseline, Day 24|"Intent to treat population:~SPARC 1103 low dose, N=47; SPARC 1103 high dose, N=42; and Placebo N=46"|||participants|||Number
2613022|NCT02027025|Primary|Least Square Mean Difference (Placebo Versus Each SPARC1103 Dose) in Change From Baseline in Modified Ashworth Score|"The modified Ashworth scale is a 6-point scale as follows:~Minimum score of 0 (better outcome) = no increase in tone Maximum score of 4 (worst outcome) = affected part(s) rigid in flexion or extension~For calculation of modified Ashworth Score, the following scores were assigned to each category of modified Ashworth scale: not testable=NA, 0=0 units, 1=1 unit, 1+ = 2 units, 2 = 3 units, and 4 = 5 units. The total score was the sum of the scores of the 6 lower extremity muscle groups on both left and right sides (range = o0 to 60)."|Baseline, Day 24|Intent to treat population: SPARC1103 low dose, N=47; SPARC 1103 high hose, N=42; and Placebo, N=46|||score on a scale||Standard Error|Least Squares Mean
2613023|NCT02026687|Other Pre-specified|Change in Pain|"Pain at rest will be assessed using a numeric rating scale from 0 (no pain) to 10 (worst imaginable pain). Pain is documented on the day of surgery (day 0), 3 times daily postoperative day 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35 and 42.~Scale: NRS Minimum value:0 Maximum value: 10. Higher scores indicate worse outcome."|Day of surgery (day 0) until 6 weeks after surgery||||units on a scale||95% Confidence Interval|Mean
2613024|NCT02026687|Secondary|Change in Quality of Life|"The questionnaire Short Form with 36 questions SF-36 will be used preoperatively and at 6 weeks after surgery. The SF-36 consists of eight scaled subscores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental Health) and two Component summary scores (physical Component summary scoer, mental component summary score). A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability."|Preoperatively and until 6 weeks after surgery||||units on a scale||Inter-Quartile Range|Median
2613025|NCT02026687|Primary|Length of Stay|From day of surgery (Day 0) until discharge after surgery|Participants will be followed for the duration of hospital stay, an expected average of 4 days||||days||Inter-Quartile Range|Median
2613026|NCT02026453|Secondary|Mean Severity-Weighted Admission Medication Order (AMO) Error Score|The severity-weighted admission medication order (AMO) error score are weighted error counts. Significant, serious, and life-threatening errors count for 1, 4, and 9 points each, respectively. Higher scores indicate either more errors or errors of greater severity. The range includes integers starting with 0 (indicating zero errors) up to infinity. For each AMH error identified, two physicians independently reviewed the relevant medications ordered at hospital admission in the context of the clinical chart. They classified each AMH error as either resulting in no AMO error, or an AMO error of significant, serious, or life-threatening severity. A third physician adjudicated disagreements. In cases where the admitting physician's knowledge of an AMH error was unclear and the orders clinically reasonable, we determined the AMH error did not lead to any AMO error. Because reviewers needed chart access to determine error severity, there was no practicable way to mask study arm.|Attempted to obtain the day after admission||||Mean Severity-Weighted AMO Error Score||95% Confidence Interval|Mean
2613027|NCT02026453|Primary|Mean Severity-weighted Admission Medication History (AMH) Error Score|The primary outcome was severity-weighted mean admission medication history (AMH) error score which are weighted error counts. Significant, serious, and life-threatening errors count for 1, 4, and 9 points each, respectively. As such, higher scores indicate either more errors or errors of greater severity. The range includes integers starting with 0 (indicating zero errors) up to infinity. To detect AMH errors, all patients received reference standard AMHs, which were compared with intervention and control group AMHs. AMH errors and resultant AMO errors were independently identified and rated by ≥2 investigators as significant, serious or life-threatening.|Attempted to obtain the day after admission||||Mean Severity-weighted AMH Error Score||95% Confidence Interval|Mean
2613028|NCT02026258|Secondary|Questionnaire Involving Pain Management and Satisfaction With the Procedure|"Binomial measurement in questionnaire on medications taken and satisfaction with the procedure~Did you take any pain medication after the procedure? Y/N (Count Yes)~Would you undergo this procedure again? Y/N (Count Yes)~Would you recommend this procedure to a friend? Y/N (Count Yes)"|4-5 weeks after first wire placement||||Participants|||Count of Participants
2613029|NCT02026258|Secondary|Questionnaire on Easiness and Satisfaction With the Procedure|"Visual analogue Scale from 0-100~Are you satisfied with your treatment? Very- Not Satisfied (0-100)~How easy was the procedure to you? Easy-Complicated (0-100)"|4-5 weeks after first wire placement||||units on a scale||Standard Deviation|Mean
2613030|NCT02026258|Secondary|Questionnaires Involving Pain Level|"Specific questions questionnaire included:~1) How much pain/discomfort at the following time points? 1) Immediately after first wire placement (T0), 2) 1 hour, (T1) 3) 12 hrs (T2) and 4) Seven days after (T3). Rated on a scale from 0-100 (No pain-Unbearable pain)"|Immediate to 1 week after wire placement (T0-T3)||||units on a scale||Standard Deviation|Mean
2613031|NCT02026258|Primary|Number of Days to Complete Alignment of Mandibular Anterior Teeth Based on Little's Irregularity Index|Days until complete alignment of mandibular anterior alignment was achieved after wire insertion on both groups. Complete alignment was based on Little's Irregularity index (Sum of contact displacement in mm between the anterior teeth from mesial of one canine to the mesial of the contralateral canine) of less than 2mm.|From the placement of the first wire to complete alignment of mandibular anteiror teeth, assessed up to 9 months||||Days to complete alignment||Standard Deviation|Mean
2613032|NCT02026206|Secondary|Quality of Life|The secondary outcome measures were quality of life as assessed by the EQ-5D (minimun 0.00, maximum 1.00). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The subscales combined to compute a total score according to EQ-5D equation formula. The higher values represent a better outcome.All data collected by self-reported sheet. Before treatment, the participants conducted a self-evaluation of pain intensity and quality of life after the next menstruation started (pre-treatment score) using the EQ-5D questionnaire. After self-therapy on 3 menstrual cycles, the participants conducted a self-evaluation of quality of life after the next menstruation started (post-treatment score) using the EQ-5D questionnaire.|within 3 months after treatment||||units on a scale||Standard Deviation|Mean
2613056|NCT02025725|Secondary|Population Pharmacokinetics|Pharmacokinetic parameters derived from the plasma concentrations of metoclopramide collected; maximum plasma concentration (Cmax), time to Cmax (Tmax), elimination half-life (t1/2), areas under the concentration-time curve (AUC) to the final sample AUC(0-t)|Study Day 7|||||||
2613033|NCT02026206|Primary|Dysmenorrheal Pain Severity|The primary outcome was menstrual pain intensity described using a 0-10 VAS scale (minimum 0, maximum 10). The higher values represent a worse outcome. All data collected by self-reported sheet. Before treatment, the participants conducted a self-evaluation of pain intensity after the next menstruation started (pre-treatment score) using the VAS. After self-therapy on 3 menstrual cycles, the participants conducted a self-evaluation of pain intensity after the next menstruation started (post-treatment score) using the VAS.|within 3 months after treatment||||units on a scale||Standard Deviation|Mean
2613034|NCT02026193|Primary|Fetal Heart Activity 1 Month Post Embryo Transfer|Fetal heart activity as demonsrated by vaginal ultrasound 1 month post embryo transfer|1 month after embryo transfer||||participants with fetal heart activity|||Number
2613035|NCT02026141|Other Pre-specified|VAS Scores|Patients will be asked to chart their VAS pain score at the 6, 12 , and 24 hour mark.|6, 12 and 24 hour marks.|||||||
2613036|NCT02026141|Secondary|Time of First Analgesia Request||time of first analgesia request from closure of skin up to 24 hours.|||||||
2613037|NCT02026141|Primary|Morphine Consumption|Patients will be provided with a patient-controlled-analgesia in which they will have morphine available for pain scores greater than 3.|24 hours||||milligrams||Standard Deviation|Mean
2613038|NCT02026063|Secondary|Change From Baseline in Subjective Global Assessment of Carcinoid Syndrome Symptoms on 11-Point Numeric Scale at Each Visit|"Participants were asked the following question to assess global symptoms associated with carcinoid syndrome (CS) on an 11-point scale: Rate the severity of your overall carcinoid symptoms over the past 7 days on a scale from 0 to 10, where 0=no symptoms and 10=worst symptoms ever experienced. A negative change from baseline indicated improvement."|Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84|PP population included the participants who received telotristat etiprate; had no major protocol deviations that interfered with collection/interpretation of efficacy data. Number analyzed=participants with data at given time-point. Participants were combined for this outcome measure as they received dose adjustments per investigator's discretion.|||score on a scale||Standard Deviation|Mean
2613039|NCT02026063|Secondary|Percentage of Participants With Adequate Relief as Per Subjective Global Assessment Question|"Participants were asked to respond to the following question: In the past 7 days, have you had adequate relief of your carcinoid syndrome bowel complaints such as diarrhea, urgent need to have a bowel movement, abdominal pain, or discomfort? The percentage of participants reporting adequate relief (answered Yes) were reported."|Baseline, Weeks 12, 24, 36, 48, 60, 72 and 84|PP population included the participants who received telotristat etiprate; had no major protocol deviations that interfered with collection/interpretation of efficacy data. Number analyzed=participants with data at given time-point. Participants were combined for this outcome measure as they received dose adjustments per investigator's discretion.|||percentage of participants|||Number
2613040|NCT02026063|Secondary|Change From Baseline in Gastrointestinal Symptoms of Carcinoid Neuroendocrine Tumors (GI.NET21) Score at Each Visit|GI.NET21 is a standardized 21-item scale composed of both multi-item scales and single-item measures that include 5 functional scales (gastrointestinal (GI) [5 items], endocrine [3 items], treatment-related [3 items], social functioning [3 items], and disease-related worries scale [DRWS] [3 items]) and 4 single items (muscle and bone pain symptom (BPS), sexual functioning, communication function (CF), body image and information about the disease). Each item is scored from 1 (not at all) to 4 (very much). All of the scales and single-item measures are transformed to a score of 0 to 100. For functioning scales higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement).|Baseline, Weeks 24, 48, 72 and 84|PP population included the participants who received telotristat etiprate; had no major protocol deviations that interfered with collection/interpretation of efficacy data. Number analyzed=participants with data at given time-point. Participants were combined for this outcome measure as they received dose adjustments per investigator's discretion.|||score on a scale||Standard Deviation|Mean
2613041|NCT02026063|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) Score at Each Visit|QLQ-C30 is a standardized 30-item scale to assess health-related quality of life composed of 5 functional scales (physical functioning [5 items], role functioning [2 items], emotional functioning [4 items], cognitive functioning [2 items], and social functioning [2 items]); 3 symptom scales (fatigue [3 items], nausea/vomiting [2 items], and pain [2 items]); a global health status (GHS) /quality of life (QOL) scale [2 items]; 6 single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties). 28 questions answered:1 (not at all) to 4 (very much) and 2 questions on overall health/QOL answered:1 (poor) to 7 (excellent). All of the scales and single-item measures are transformed to a score:0 to 100. For functioning scales and global QOL higher scores indicate better functioning (a positive change from Baseline indicates improvement); for symptom scales higher scores indicate more severe symptoms (a negative change from Baseline indicates improvement).|Baseline, Weeks 24, 48, 72 and 84|Per-Protocol (PP) population=participants who received telotristat etiprate;had no major protocol deviations that interfered with collection/interpretation of efficacy data. Number analyzed=participants with data at given time-point.Participants were combined for this outcome measure as they received dose adjustments per investigator’s discretion.|||score on a scale||Standard Deviation|Mean
2613042|NCT02026063|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE includes any noxious, pathological, or unintended change in anatomical, physiological, or metabolic functions as indicated by physical signs or symptoms occurring in any phase of the clinical study whether or not considered related to the study medication. A TEAE is an AE that occurs or worsens after receiving study drug.|First dose of study drug (Day 1) up to 15 days post last dose (approximately up to 236 weeks)|Safety Population included all participants who received any fraction of a dose of telotristat etiprate during the study.|||Participants|||Count of Participants
2613043|NCT02026011|Secondary|Alcohol Self-administration - Number of Drinks|Total number of drinks consumed during the alcohol self-administration task|Alcohol self-administration period was 1 hour long|Participants who completed at least one experimental session.|||drinks consumed||Standard Deviation|Mean
2613044|NCT02026011|Primary|Neural Response to Alcohol Cues|Alcohol taste cues task for functional magnetic resonance imaging (fMRI). Region of Interest (ROI) were atomically defined using the Harvard-Oxford atlas in standard Montreal Neurological Institute (MNI) space, which were transformed into individual participants' native space using Functional Magnetic Resonance Imaging of the Brain Software Library (FSL). Contrast estimates are for Alc > Water cue, and are arbitrary units.|During the alcohol cue exposure fMRI paradigm which is expected to last 45 minutes|Participants who completed at least one experimental session and whose neuroimaging data was not excluded due to excessive motion (>2 mm translation) and/or poor registration.|||Mean contrast estimate for Alc>Water cue||Standard Deviation|Mean
2613045|NCT02026011|Primary|Subjective Response - Sedation|The Biphasic Alcohol Effects Scale (BAES) Sedation Subscale consists of 14 items designed to capture the sedating effects of alcohol, rated on an 11-point scale (0 = not at all. 10 = extremely). Total score for the sedation subscale ranges from 0-70.|The BAES Sedation Subscale was administered at baseline and three levels of breath alcohol concentration: 0.2 g/dl. 0.04, g/dl, and 0.06 g/dl taking place within approximately 1.5 hours|Participants who completed at least one experimental session.|||score on a scale||Standard Deviation|Mean
2613046|NCT02026011|Primary|Subjective Response - Stimulation|The Biphasic Alcohol Effects Scale (BAES) Stimulant Subscale consists of 14 items designed to capture the stimulant effects of alcohol, rated on an 11-point scale (0 = not at all. 10 = extremely). Total score for the stimulant subscale ranges from 0-70.|The BAES Stimulant Subscale was administered at baseline and three levels of breath alcohol concentration: 0.2 g/dl. 0.04, g/dl, and 0.06 g/dl taking place within approximately 1.5 hours|Participants who completed at least one experimental session.|||score on a scale||Standard Deviation|Mean
2613047|NCT02026011|Primary|Subjective Response - Craving for Alcohol|Alcohol Urge Questionnaire (AUQ) is used to assess subjective experiences of craving for alcohol. It consists of 8 items, each rated on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). A summary score is used at each assessment time point. The AUQ was administered at baseline and three levels of breath alcohol concentration: 0.02 g/dl. 0.04, g/dl, and 0.06 g/dl.|The AUQ was administered across a period of approximately 1.5 hours.|Participants who completed at least one experimental session.|||score on a scale||Standard Deviation|Mean
2613048|NCT02025907|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) at Week 26||Baseline and Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||millimeter of mercury (mmHg)||Standard Error|Least Squares Mean
2613049|NCT02025907|Secondary|Percentage of Participants With HbA1c Less Than (<) 7.0 Percent at Week 26||Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2613050|NCT02025907|Secondary|Percent Change From Baseline in Body Weight at Week 26||Baseline and Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||percent change||Standard Error|Least Squares Mean
2613051|NCT02025907|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26||Baseline and Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||millimoles per liter||Standard Error|Least Squares Mean
2613052|NCT02025907|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26||Baseline and Week 26|mITT population included all randomized participants who received at least 1 dose of double-blind study drug. A total of 3 participants were excluded from the mITT population due to potential misconduct and GCP compliance issues. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2613053|NCT02025829|Secondary|Sputum Inflammatory Mediators: IL-1β, IL-6, IL-8, IL-17A, and Neutrophil Elastase|In the Exacerbation/IV Antibiotics Cohort--Measurement of sputum inflammatory mediators by multiplex assay for IL-1β, IL-6, IL-8, and IL-17A. Neutrophil elastase determined by colorimetric assay. Measurements at the beginning of IV antibiotic treatment and after 2 weeks antibiotic treatment for a pulmonary exacerbation|End of Treatment, two weeks. Samples will be obtained from each study volunteer at the beginning of IV antibiotic treatment and at the completion of antibiotic treatment for a pulmonary exacerbation||||pg/ml||Standard Deviation|Mean
2613054|NCT02025829|Secondary|Sputum Inflammatory Mediators: IL-1β, IL-6, IL-8, IL-17A, TGF-β, TNF-α, and Neutrophil Elastase|In the Clinically Stable Cohort--Measurement of sputum inflammatory mediators: IL-1β, IL-6, IL-8, IL-17A, TGF-β, TNF-α, and neutrophil elastase|Samples will be obtained at one outpatient clinic visit during the next calendar year|Data not collected and will never be analyzed.||||||
2613055|NCT02025829|Primary|Change in Sputum IL-17 Neutrophils|In the Exacerbation/IV Antibiotics Cohort--Subjects will serve as their own controls. The percentage of neutrophils (in sputum) positive for IL-17 was determined by flow cytometry for each subject at the beginning and end of treatment for a pulmonary exacerbation. Sputum IL-17 neutrophil counts will be compared to the change in lung function (FEV1) as determined by spirometry (American Thoracic Society standards).|End of Treatment, two weeks. Samples will be obtained from each study volunteer at the beginning of IV antibiotic treatment and at the completion of antibiotic treatment for a pulmonary exacerbation|"Regarding Clinically Stable Arm: Because very few neutrophils at the end of treatment for a pulmonary exacerbation were positive for IL-17, it was determined not to undertake studies examining sputum neutrophils during periods of clinical stability."|||% of neutrophils positive for IL-17||Standard Deviation|Mean
2615707|NCT01998360|Secondary|Number of Participants With Complete Epithelialization (Completely Healed) at 4 Weeks|The number of participants with complete epithelialization (completely healed) at 4 weeks|1 month||||participants|||Number
2613057|NCT02025725|Primary|Patient Reported Outcome (PRO) Symptom Diary: Gastroparesis Symptom Assessment (GSA)|Change in mean daily Gastroparesis Symptom Assessment total score; minimum value=0 (no symptoms) and maximum value =4 (very severe symptoms)|Baseline Period to Week 4 of the Treatment Period|Intent-to-Treat (ITT) Population|||score on a scale||Standard Deviation|Least Squares Mean
2613058|NCT02025647|Post-Hoc|Mental Health Prevalence Rates Comparison|"What is the percentage of subjects where the provider was unaware of any mental health concerns yet Innerview identified them as having hit a rule out or diagnostic consideration for a mental health disorder vs the US 12 Month Prevalence Rate?~US 12 Month Prevalence Rate = 26.2% (http://www.ncbi.nlm.nih.gov/pubmed/15939839)"|Study Duration|104 subjects had no known mental health concerns|||percentage of subjects|||Number
2613059|NCT02025647|Other Pre-specified|Completion Times|On average, the number of minutes taken to complete both the narrative and rating modules?|Study Duration||||minutes||Inter-Quartile Range|Median
2613060|NCT02025647|Secondary|Subject Survey (Question 10)|It took an acceptable amount of time to tell my story. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate||||units on a scale||Standard Deviation|Mean
2613061|NCT02025647|Secondary|Subject Survey (Question 9)|The demonstration showed me how to use the system. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate||||units on a scale||Standard Deviation|Mean
2613062|NCT02025647|Secondary|Subject Survey (Question 8)|Telling my story helped me prepare for treatment. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate||||units on a scale||Standard Deviation|Mean
2613063|NCT02025647|Secondary|Subject Survey (Question 7)|Q7. I would encourage other doctors to use this system. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate||||units on a scale||Standard Deviation|Mean
2613064|NCT02025647|Secondary|Subject Survey (Question 6)|"I was able to select words and phrases that I normally use to talk about my symptoms.~Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Immediate||||units on a scale||Standard Deviation|Mean
2613065|NCT02025647|Secondary|Subject Survey (Question 5)|The program included all of the symptoms I wanted to share with my doctor. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate||||units on a scale||Standard Deviation|Mean
2613066|NCT02025647|Secondary|Subject Survey (Question 4)|This tool will contribute positively to my health care. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate||||units on a scale||Standard Deviation|Mean
2613067|NCT02025647|Secondary|Subject Survey (Question 3)|The program was easy to use. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate||||units on a scale||Standard Deviation|Mean
2613068|NCT02025647|Secondary|Subject Survey (Question 2)|"Compared to other health care questionnaires I have taken, I would rate this system highly.~Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Immediate||||units on a scale||Standard Deviation|Mean
2613069|NCT02025647|Secondary|Subject Survey (Question 1)|I am satisfied with how I was able to tell my story. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Immediate||||units on a scale||Standard Deviation|Mean
2613070|NCT02025647|Secondary|Provider Survey (Question 11)|On average, how much extra time do you estimate that you spent with your patients evaluating and discussing the information collected through Innerview?|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||minutes||Full Range|Mean
2613071|NCT02025647|Secondary|Provider Survey (Question 10)|The benefits of Innerview will outweigh the effort to implement and operate it. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||units on a scale||Full Range|Mean
2613072|NCT02025647|Secondary|Provider Survey (Question 9)|In my opinion, incorporating Innerview into my practice would require an acceptable amount of time and effort from myself and staff Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||units on a scale||Full Range|Mean
2613073|NCT02025647|Secondary|Provider Survey (Question 8)|My patients reacted positively to Innerview. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||units on a scale||Full Range|Mean
2613074|NCT02025647|Secondary|Provider Survey (Question 7)|Innerview will function well within my current work flow Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects, one investigator did not respond to this item.|||units on a scale||Full Range|Mean
2613075|NCT02025647|Secondary|Provider Survey (Question 6)|"Innerview will help me better identify patients who suffer from a mental health concern.~Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||units on a scale||Full Range|Mean
2613076|NCT02025647|Secondary|Provider Survey (Question 5)|"In my opinion, the Innerview narrative process will help prepare patients for treatment.~Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||units on a scale||Full Range|Mean
2613077|NCT02025647|Secondary|Provider Survey (Question 4)|The information provided by Innerview was well communicated in the reports. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||units on a scale||Full Range|Mean
2613078|NCT02025647|Secondary|Provider Survey (Question 3)|The information provided by Innerview was well organized in the reports. Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||units on a scale||Full Range|Mean
2613079|NCT02025647|Secondary|Provider Survey (Question 2)|"The information provided by Innerview was consistent with my previous observations of my patients.~Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||units on a scale||Full Range|Mean
2613080|NCT02025647|Secondary|Provider Survey (Question 1)|"The information provided by Innerview is valuable in understanding and treating my patients.~Where 1 is strongly disagree 2 is disagree 3 is neutral 4 is agree 5 is strongly agree"|Administered Innerview session on at least 15 subjects|This is an investigator survey meant to measure the usefullness, feasibility and acceptability of the tool. Therefore, this question was not asked of the subjects but of their providers. There were a total of 6 providers/investigators that enrolled 15 or more subjects.|||units on a scale||Full Range|Mean
2613081|NCT02025647|Primary|Standard Error of Measure for the Individualized Rating Scale (Rating Module)|What is the standard error of measurement (SEM) for test/retest symptom ratings on a 0 - 10 point scale|approximate 5 minutes between ratings||||units on a scale|||Number
2613082|NCT02025647|Primary|Reliability of the Narrative Module|What is the consistency of the diagnostic criteria generated by two administrations, 1 to 2 days apart?|24-48 hours||||percentage of agreement||Standard Deviation|Mean
2613083|NCT02025647|Primary|Accuracy of the Narrative Module|Out of 139 subjects using Innerview for the first time, how many subjects approved their initial version of their narrative versus chose to start over?|Immediate||||participants|||Number
2613084|NCT02025621|Other Pre-specified|Rehospitalization for Any Cause Through Day 30||30 days|patients receiving study drug, by study drug received|||Participants|||Count of Participants
2613085|NCT02025621|Other Pre-specified|Occurrence of All-cause Mortality From Randomization Through Day 90||90 days|all patients receiving study drug, according to the drug actually received|||Participants|||Count of Participants
2613086|NCT02025621|Secondary|Postoperative Use of Secondary Inotrope|Use of (dobutamine, milrinone, epinephrine, dopamine) associated with index surgical procedure at 24 hours after initiation of surgery|24 hours||||Participants|||Count of Participants
2613087|NCT02025621|Secondary|Incidence of Low Cardiac Output Syndrome (LCOS)|Use of a mechanical cardiac assist device within 5 days after surgery, two consecutive measurements of low cardiac output (defined as a cardiac output of ≤2.0 liters per minute per square meter of bodysurface area), one measurement of low cardiac output plus the use of two or more inotropes at or beyond 24 hours after surgery, or the use of two or more inotropes at or beyond 24 hours after surgery with the indicated reason being low cardiac output.|5 days|mITT; patients receiving any study drug|||Participants|||Count of Participants
2613088|NCT02025621|Secondary|Duration of Intensive Care Unit/Critical or Coronary Care Unit (ICU/CCU) (Days)|Duration of intensive care unit/critical or coronary care unit (ICU/CCU) length of stay (LOS) in days|participants will be followed for during the participant's hospital stay up to 30 days|mITT; patients that received any study drug|||days||Inter-Quartile Range|Median
2613089|NCT02025621|Primary|Number of Quad Efficacy Endpoint Events|Composite of all-cause death (at 30 days), or perioperative nonfatal MI [CK-MB >10xULN or >100 ng/mL, CK-MB >5xULN or 50 ng/mL with new Q wave (>0.04 seconds wide in two contiguous leads) or new left bundle branch block)] (through Day 5), or need for renal dialysis (through Day 30), or use of mechanical assist device (IABP, LVAD or ECMO) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement) (through Day 5)|30 days|mITT; population receiving any study drug|||events|||Number
2613090|NCT02025621|Primary|Number of Dual Efficacy Endpoint Events|The all-cause death at 30 days or use of mechanical assist device (IABP, LVAD or ECMO) following the start of surgery for poor cardiac function despite inotropic support and adequate fluid replacement) through Day 5|30 days|mITT; population receiving any study drug|||events|||Number
2613091|NCT02025530|Post-Hoc|Screening for Gestational Diabetes and Fasting Plasma Glucose|Performance of 75g oral glucose tolerance test and the results of glucose tolerance test in cases and controls|During index pregnancy|Women were excluded from this analysis if they had pre-existing diabetes. Women should have been screened using oral glucose tolerance test if they had a positive family history, were of South Asian or Black Caribbean ethnicity, had a body mass index ≥ 30 kg/m2, or previous pregnancy effected by GDM or macrosomic (birthweight ≥4.5 kg) birth.|||Participants|||Count of Participants
2613092|NCT02025530|Secondary|Maternal Perception of Fetal Activity|Maternal Perception of Fetal Activity reported via the researcher-administered questionnaire.|Two weeks prior to stillbirth / interview||||Participants|||Count of Participants
2613093|NCT02025530|Primary|Maternal Sleep Practices During Pregnancy|Self-reported going to sleep position in late pregnancy|One night prior to questionnaire||||Participants|||Count of Participants
2613094|NCT02025205|Secondary|Absolute Change in EQ-5D VAS (Health State Today) Score From Baseline to 3 Months|Mean absolute change in the EQ-5D VAS (Health State Today) Score from Baseline to 3 months in the EBV group compared to the SoC group. Scores range from 0 to 100, with higher scores indicating better outcome.|At baseline and after 3 months|ITT population|||points on a scale||Standard Deviation|Mean
2613095|NCT02025205|Secondary|Percent Change (%) in EQ-5D Summary Index From Baseline to 3 Months|Mean percent change in EQ-5D Summary Index from Baseline to 3 months in the EBV group compared to the SoC group.|At baseline and after 3 months|ITT population|||percent change||Standard Deviation|Mean
2613096|NCT02025205|Secondary|Absolute Change in EQ-5D Summary Index From Baseline to 3 Months|"Mean absolute change in the EQ-5D Summary Index from Baseline to 3 months in the EBV group compared to the SoC group.~EQ-5D is a standardized instrument to measure health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS.~The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D health states may be converted into a single summary index by applying a formula that attaches weights to each of the levels in each dimension. The maximum score of 1 indicates the best health state, while 0 indicates the worst health state."|At baseline and after 3 months|ITT population|||points on a scale||Standard Deviation|Mean
2613097|NCT02025205|Secondary|Percent Change (%) in CAT Total Score From Baseline to 3 Months|The COPD Assessment Test (CAT) is an eight-item questionnaire designed to quantify the impact of COPD symptoms on the health status of patients. The CAT provides a score of 0-40 to indicate the impact of disease. Higher scores denote a more severe impact of COPD on a patient's life.|At baseline and after 3 months|ITT population|||percent change||Standard Deviation|Mean
2613098|NCT02025205|Secondary|Absolute Change in the CAT Total Score From Baseline to 3 Months|"Mean absolute change in the COPD Assessment Test (CAT) Total Score from Baseline to 3 months in the EBV group compared to the SoC group.~The COPD Assessment Test (CAT) is an eight-item questionnaire designed to quantify the impact of COPD symptoms on the health status of patients. The CAT provides a score of 0-40 to indicate the impact of disease."|At baseline and after 3 months|ITT population|||points on a scale||Standard Deviation|Mean
2613099|NCT02025205|Secondary|Percent Change (%) in the mMRC Dyspnea Score From Baseline to 3 Months|Mean percent change in the mMRC Dyspnea Score from Baseline to 3 months in the EBV group compared to the SoC group. The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations.|At baseline and after 3 months|ITT population|||Percent change||Standard Deviation|Mean
2613100|NCT02025205|Secondary|Absolute Change in the mMRC Dyspnea Score From Baseline to 3 Months|Mean absolute change in the Modified Medical Research Council (mMRC) Dyspnea Score from Baseline to 3 months in the EBV group compared to the SoC group. The mMRC (Modified Medical Research Council) stratifies severity of dyspnea in respiratory diseases. The severity of dyspnea is rated on a scale of 0 to 4, with higher scores indicating more limitations.|At baseline and after 3 months|ITT population|||points on a scale||Standard Deviation|Mean
2613101|NCT02025205|Secondary|Percent Change (%) in the SGRQ Total Score From Baseline to 3 Months|Mean percent change in the SGRQ Total Score from Baseline to 3 months in the EBV group compared to the SoC group|At baseline and after 3 months|ITT population|||percent change||Standard Deviation|Mean
2613102|NCT02025205|Secondary|Absolute Change in the SGRQ Total Score From Baseline to 3 Months|Mean absolute change in the St. George's Respiratory Questionnaire Total Score from Baseline to 3 months in the EBV group compared to the SoC group. Scores range from 0 to 100, with higher scores indicating more limitations.|At baseline and after 3 months|ITT population|||points on a scale||Standard Deviation|Mean
2613103|NCT02025205|Secondary|Percent Change in Six-Minute Walk Distance at 3 Months|Mean percent change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC|At baseline and after 3 months|ITT population|||Percent change||Standard Deviation|Mean
2613104|NCT02025205|Secondary|Absolute Change in Six-Minute Walk Distance at 3 Months|Mean absolute change in the 6MWD from Baseline to 3 months in the EBV group compared to the SOC|At baseline and after 3 months|ITT population|||meters||Standard Deviation|Mean
2613105|NCT02025205|Secondary|Percent Predicted Change in Residual Volume at 3 Months|Percent predicted change in RV relative to Baseline at 3 months between the EBV and SoC groups|At baseline and after 3 months|ITT population|||Percent change||Standard Deviation|Mean
2613106|NCT02025205|Secondary|Percent Change in Residual Volume (RV) at 3 Months|Mean percent change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups|At baseline and after 3 months|ITT population|||Percent change||Standard Deviation|Mean
2613107|NCT02025205|Secondary|Absolute Change in Residual Volume (RV) at 3 Months|Mean absolute change in Residual Volume relative to Baseline at 3 months between the EBV and SoC groups|At baseline and after 3 months|ITT population|||liters||Standard Deviation|Mean
2613108|NCT02025205|Secondary|Absolute Change in FEV1 (% Predicted) Post Bronchodilator at 3 Months|The mean absolute change in FEV1(% Predicted) relative to Baseline at 3 months between the EBV and SoC groups|At baseline and after 3 months|ITT population|||Percent predicted||Standard Deviation|Mean
2613109|NCT02025205|Secondary|Absolute Change in FEV1 (L) Post Bronchodilator at 3 Months|The mean absolute change in FEV1(L) relative to Baseline at 3 months between the EBV and SoC groups|At baseline and after 3 months|ITT population|||liters||Standard Deviation|Mean
2613110|NCT02025205|Secondary|Percent of Subjects in the EBV Group With a Target Lobe Volume Reduction (TLVR) of ≥ 350ml at 3 Months|The threshold of TLVR ≥350 mL was used to determine the proportion of subjects that achieved this amount of TLVR in the EBV group.|At baseline and after 3 months|ITT population|||Participants|||Count of Participants
2613111|NCT02025205|Secondary|Percent Change in Target Lobe Volume for EBV Group (ITT Population)|Target Lobe Volume Reduction (TLVR) was evaluated by quantitative analysis of HRCT scans at Baseline and at 3-months post-valve placement to measure the target lobe volume.|At baseline and after 3 months||||Percent change||Standard Deviation|Mean
2613112|NCT02025205|Secondary|Absolute Change in Target Lobe Volume for EBV Group (ITT Population)|Target Lobe Volume Reduction (TLVR) was evaluated by quantitative analysis of HRCT scans at Baseline and at 3-months post-valve placement to measure the target lobe volume.|At baseline and after 3 months||||mL||Standard Deviation|Mean
2613114|NCT02025179|Secondary|Bone-specific Alkaline Phosphatase|"The mean percent change in Bone-specific alkaline phosphatase from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The Baseline refers to the baseline at the parent protocol (NCT01225055). The 24 months refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179)."|Baseline to 24 Months|"One subject in Teriparatide and vibration group was lost to follow-up"|||Percent change||95% Confidence Interval|Mean
2613115|NCT02025179|Secondary|Amino-terminal Propeptide of Type 1 Collagen|"The mean percent change in Amino-terminal of type 1 collagen from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The Baseline refers to the baseline at the parent protocol (NCT01225055). The 24 months refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179)."|Baseline to 24 Months|"One subject in Teriparatide and vibration group was lost to follow-up"|||Percent change||95% Confidence Interval|Mean
2613116|NCT02025179|Secondary|Bone Mineral Density (BMD) by DXA at Femoral Neck|"The mean percent change in BMD of the femoral neck after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The Baseline refers to the baseline at the parent protocol (NCT01225055). The 24 months refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179)."|Baseline to 24 Months|"One subject in Teriparatide and vibration group was lost to follow-up"|||Percent change||95% Confidence Interval|Mean
2613117|NCT02025179|Secondary|Bone Mineral Density (BMD) by DXA at the Lumbar Spine|"The mean percent change in BMD at the lumbar spine from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The Baseline refers to the baseline at the parent protocol (NCT01225055). The 24 months refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179)."|Baseline to 24 Months|"One subject in Teriparatide and vibration group was lost to follow-up. Another subject in Teriparatide and vibration spine could not be analyzed due to a baclofen pump."|||Percent change||95% Confidence Interval|Mean
2613118|NCT02025179|Secondary|C-terminal Telopeptide|"The mean percent change in C-terminal telopeptide from baseline after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The Baseline refers to the baseline at the parent protocol (NCT01225055). The 24 months refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179)."|Baseline to 24 Months|"One subject in Teriparatide and vibration group was lost to follow-up"|||Percent change||95% Confidence Interval|Mean
2613119|NCT02025179|Primary|Bone Mineral Density (BMD) of the Total Hip as Assessed by Dual-energy X-ray Absorptiometry (DXA)|"The mean percent change in BMD of the total hip after 24 months of treatment. Arms/Groups (3) below are divided into the Arms/Groups these subjects were in the parent protocol (NCT01225055) for the 12 month duration of this previous study. These subjects were then enrolled in this 12 month extension study (NCT02025179) and all received Teriparatide and vibration for 12 months as described in the protocol section. The Baseline refers to the baseline at the parent protocol (NCT01225055). The 24 months refers to period after the completion of the 12 month parent protocol (NCT01225055) and this 12 month extension study (NCT02025179)."|Baseline to 24 months|"One subject in Teriparatide and vibration group was lost to follow-up"|||Percent change||95% Confidence Interval|Mean
2613120|NCT02025075|Secondary|Postoperative Pain|The patient will be inquired about pain with a visual analogue scale (VAS). Pain will be evaluated as incisional pain using VAS (0 = no pain; 100 = worst possible pain).|Postoperative Day 1||||units on a scale||Standard Deviation|Mean
2613121|NCT02025075|Primary|Cerebral Oximetry (%)|Regional cerebral oxygenation will be assessed continuously during the intraoperative period using NIRS technology.|BL; During pneumoperitoneum; Stage w/2 depths neuromuscular blockade targeted - TOF1 and Deep: 1-2 twitches in post-tetanic count (50-Hz tetanus followed by three-second pause and 15 1-Hz stimuli); and immediately after release of pneumoperitoneum||||percent cerebral saturation||Standard Deviation|Mean
2613122|NCT02025075|Primary|Ejection Fraction (%)|To assess cardiac performance, transthoracic echocardiography will be used. Ejection fraction was measured as fractional shortening (FS). FS is the fraction of any diastolic dimension that is lost in systole. FS = 100*(LVEDD - LVESD) / LVEDD, LVEDD = LV end-diastolic dimension (mm); LVESD = LV end-systolic dimension (mm).|BL; During pneumoperitoneum; Stage w/2 depths neuromuscular blockade targeted - TOF1 and Deep: 1-2 twitches in post-tetanic count (50-Hz tetanus followed by three-second pause and 15 1-Hz stimuli); and immediately after release of pneumoperitoneum||||% fractional shortening||Standard Deviation|Mean
2613134|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) in Part B, Cohort 5|Serum samples were obtained for PK assessment.|Day 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||h*ng/mL||Standard Deviation|Mean
2615708|NCT01998360|Secondary|Blood Loss|Number of ml of blood lost during the procedure, as assessed by the surgeon|During procedure (up to 1 hour)||||ml||Inter-Quartile Range|Median
2613123|NCT02025075|Primary|Regional Change in Air Content (Delta Z, %)|We will measure continuous respiratory flows and pressures in the intraoperative period to assess continuously the compliance and resistance of the respiratory system (T1 to T5). In addition, we will use an esophageal balloon to assess esophageal pressures and partition the global mechanical properties of the respiratory system, into their lung and chest wall components (T1 to T5). Regional lung aeration will be assessed for quantification of intraoperative lung recruitment using Electrical Impedance Tomography (EIT) (T0 to T6). Percent change was calculated using electrical impedance measurements obtained at time T0 as reference.|BL; During pneumoperitoneum; Stage w/2 depths neuromuscular blockade targeted - TOF1 and Deep: 1-2 twitches in post-tetanic count (50-Hz tetanus followed by three-second pause and 15 1-Hz stimuli); and immediately after release of pneumoperitoneum||||percent change||Standard Deviation|Mean
2613124|NCT02024971|Secondary|Change From Baseline in Fasting Insulin|Tabulation of fasting insulin test values and change at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data.|Baseline and Months 3, 6, 9, 12 and final assessment|The analysis was performed in the efficacy assessment population (n=905).|||μU/dL||Standard Deviation|Mean
2613125|NCT02024971|Secondary|Change From Baseline in Fasting Blood Glucose|Tabulation of fasting blood glucose test values and change at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data.|Baseline and Months 3, 6, 9, 12 and final assessment|The analysis was performed in the efficacy assessment population (n=905).|||mg/dL||Standard Deviation|Mean
2613126|NCT02024971|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|Tabulation of the HbA1c test value and change at each test time point (test value at each test time point after baseline - test value at baseline). A negative change from Baseline indicates improvement. n=number of participants analyzed at each time point. Final assessment is defined as a cumulative assessment of Month 12 and Early Termination Visit data.|Baseline and Months 3, 6, 9, 12 and final assessment|The analysis was performed in the efficacy assessment population (n=905).|||percentage of HbA1c||Standard Deviation|Mean
2613127|NCT02024971|Primary|Number of Participants With Adverse Drug Reactions|Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.|12 months|Safety Analysis Set, all patients for whom data was collected in case report forms, except those who were treated before the contract period, those who were enrolled after Day 15 of the start of treatment with Metact Combination Tablets, and those with missing data after treatment (missed visits).|||participants|||Number
2613128|NCT02024932|Secondary|Compare Dose Normalized Log-transformed AUCinf Following IV and SC Administrations|Serum samples were obtained for PK assessment.|In Part A: days 1 and 15, pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose.|This PK parameter was not analyzed in either Part A or Part B because there were insufficient data points after Cmax. Therefore, this parameter could not be calculated.||||||
2613129|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUCinf)|Serum samples were obtained for PK assessment.|Part A: days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose. Part B: days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|This PK parameter was not analyzed in either Part A or Part B because there were insufficient data points after Cmax. Therefore, this parameter could not be calculated.||||||
2613130|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Terminal Elimination Half-life (T1/2)|Serum samples were obtained for PK assessment.|Part A: days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose. Part B: days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|This PK parameter was not analyzed in either Part A or Part B because there were insufficient data points after Cmax. Therefore, this parameter could not be calculated.||||||
2613131|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)|Serum samples were obtained for PK assessment.|Part A: days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose. Part B: days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|This PK parameter was not analyzed in either Part A or Part B because there were insufficient data points after Cmax. Therefore, this parameter could not be calculated.||||||
2613132|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857:The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part B, Cohort 5||Days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||h*ng/mL||Standard Deviation|Mean
2613133|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857:The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part B, Cohort 4|Serum samples were obtained for the PK assessment.|Days 1: pre-dose, 1, 4, 24, 48 hours post-dose|The PK analysis set, which included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data, was analyzed.|||H*ng/mL||Standard Deviation|Mean
2613174|NCT02024477|Secondary|Arterial Stiffness|Arterial stiffness assessed using Vascular Flow and wave measurement equipment, SphygmoCor CP system from ATCOR. Reported as Augmentation Index adjusted for a heart rate of 75. Augmentation index (AIx) is a measure of systemic arterial stiffness derived from the ascending aortic pressure waveform. Lower the value, better correlated outcome as positive augmentation represents stiffer artery.|Baseline, 6 and 12 weeks post saxagliptin||||Augmentation Index||Standard Deviation|Mean
2613135|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part B, Cohort 5|Serum samples were obtained for PK assessment.|Days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||hours||Standard Deviation|Mean
2613136|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part B, Cohort 4|Serum samples were obtained for PK assessment.|Days 1: pre-dose, 1, 4, 24, 48 hours post-dose|The PK analysis set, which included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data, was analyzed.|||hours||Standard Deviation|Mean
2613137|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part B, Cohort 5|Serum samples were obtained for PK assessment.|Days 1 and 36: pre-dose, 1, 4, 24, 48 hours post-dose. Day 78: pre-dose, 1, 4, 24, 48, 168 hours post-dose.|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||ng/mL||Standard Deviation|Mean
2613138|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part B, Cohort 4|Serum samples were obtained for PK assessment.|Days 1: pre-dose, 1, 4, 24, 48 hours post-dose|The PK analysis set, which included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data, was analyzed.|||ng/mL||Standard Deviation|Mean
2613139|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part A, Cohort 2|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||h*ng/mL||Standard Deviation|Mean
2613140|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Plasma Concentration-time Curve From Zero to 48 Hours (AUC0_48h) in Part A, Cohort 1|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||h*ng/mL||Standard Deviation|Mean
2613141|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) in Part A, Cohort 2|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||H*ng/mL||Standard Deviation|Mean
2613142|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: The Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) in Part A, Cohort 1|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||h*ng/mL||Standard Deviation|Mean
2613143|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part A, Cohort 2|Serum samples were obtained for PK assessment.|Day 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||hours||Standard Deviation|Mean
2613144|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part A, Cohort 1|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||hours||Standard Deviation|Mean
2613145|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part A, Cohort 2|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose. Day 57: pre-dose, 1, 4, 12, 24, 48, 168, 504 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||ng/mL||Standard Deviation|Mean
2613175|NCT02024477|Secondary|Adiposity|measured using a Tanita Body Composition Fat Analyzer scale, measured as percentage body fat|Baseline, 6 and 12 weeks post saxagliptin||||% of Body fat||Standard Deviation|Mean
2613176|NCT02024477|Secondary|Glycemic Control|measuring HbA1c levels|Baseline, 6 and 12 weeks post saxagliptin||||% of Glycosylated Hemoglobin||Standard Deviation|Mean
2613146|NCT02024932|Secondary|Plasma Pharmacokinetics (PK) of BVS857: Observed Maximum Concentration Following Drug Administration (Cmax) in Part A, Cohort 1|Serum samples were obtained for PK assessment.|Days 1, 15, 29, 43: pre-dose, 1, 4, 12, 24, 48, 168 hours post-dose|For each time point, only participants from the PK set with valid measurements at that time point were analyzed. The PK analysis set included participants with at least one available valid PK concentration measurement who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||ng/mL||Standard Deviation|Mean
2613147|NCT02024932|Secondary|Mean Change From Baseline in Total Lean Body Mass (LBM) in Part B, Cohort 5|LBM was assessed by dual-energy X-ray (DXA) absorptiometry. A positive change from baseline indicate improvement.|Baseline, Day 85|The PD analysis set was considered for the analysis. However, only participants who had evaluable data at both baseline and day 85, were included in the analysis. The PD set included participants with evaluable PD data who received any study drug and had no protocol deviations with relevant impact on PD data.|||kilograms||Standard Deviation|Mean
2613148|NCT02024932|Secondary|Mean Change From Baseline in Score on the Adult Myopathy Assessment Tool (AMAT) in Part B, Cohort 5|The AMAT rated physical function and muscle endurance, with higher scores indicating better performance. The tool includes 7 timed functional tasks rated on a scale from 0 - 21 and 6 endurance tasks rated on a scale from 0 - 24. The range for the total score was from 0 (worst) to 45 (best). A positive change from baseline indicates improvement.|Baseline, Day 85|The PD set included, which included participants with evaluable PD data who received any study drug and had no protocol deviations with relevant impact on PD data, was analyzed.|||score on a scale||Standard Deviation|Mean
2613149|NCT02024932|Primary|Mean Percent Change From Baseline in Thigh Muscle Volume in Part B, Cohort 5|Thigh muscle volume was assessed by magnetic resonance imaging (MRI). Change from baseline was calculated from the ratio of the post-baseline mean value to the baseline mean value: [(Day 85/baseline) - 1)] x 100. A positive change from baseline indicates improvement.|Baseline, Day 85|The PD analysis set was considered for the analysis. However, only participants who had evaluable data at both baseline and day 85, were included in the analysis. The PD set included participants with evaluable PD data who received any study drug and had no protocol deviations with relevant impact on PD data.|||Percent change||Standard Deviation|Mean
2613150|NCT02024932|Primary|Number of Mild, Moderate and Severe Adverse Events as a Measure of Safety and Tolerability|Safety was monitored throughout the study.|After 78 days in Part A and after 85 days in Part B.|The safety analysis set, which included participants who received any study drug, was analyzed.|||Participants|||Number
2613151|NCT02024932|Primary|Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths as a Measure of Safety and Tolerability|Safety was monitored throughout the study.|After 78 days in Part A and after 85 days in Part B.|The safety analysis set, which included participants who received any study drug, was analyzed.|||Participants|||Number
2613152|NCT02024867|Secondary|Recurrent Skin Infections Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus|Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.|1 month after surgical drainage||||participants|||Number
2613153|NCT02024867|Secondary|Recurrent Skin Infections Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus|Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.|1 month after surgical drainage||||participants|||Number
2613154|NCT02024867|Primary|Treatment Failures Among Patients Infected With Methicillin-Sensitive Staphylococcus Aureus|Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.|up to 2 weeks after surgical drainage||||participants|||Number
2613155|NCT02024867|Primary|Treatment Failures Among Patients Infected With Methicillin-Resistant Staphylococcus Aureus|Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.|up to 2 weeks after surgical drainage||||participants|||Number
2613156|NCT02024867|Secondary|Recurrent Skin Infections|Rate of recurrent skin infection among follow-up responders 1 month after enrollment. Patients who were treatment failures were excluded from this analysis since they all received additional medical intervention that could affect the outcome measure.|1 month after surgical drainage||||participants|||Number
2613157|NCT02024867|Primary|Treatment Failures|Treatment failures were defined as persistent or increased size of the original abscess requiring further medical or surgical intervention. Treatment cure was defined as no or minimal tenderness, erythema, fever, wound drainage, warmth, fluctuance or induration at the 10 to 14 day follow-up.|up to 2 weeks after surgical drainage||||participants|||Number
2613158|NCT02024750|Secondary|Change In Parent Fear of Hypoglycemia (FOH) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention|Mean change in parent fear of hypoglycemia per month (slope), during and post-intervention. Parent fear of hypoglycemia is measured by the Hypoglycemia Fear Survey Worry Subscale. Possible scores range from 15 to 75 with higher scores indicating greater fear of hypoglycemia. Positive slopes reflect increasing fear of hypoglycemia.|Up to 2 time points during the intervention (12 months) and up to 2 time points in the post-intervention period (12 months)|214 parents were analyzed for up to 2 time points during the intervention and up to 2 time points in the post-intervention period. Models include data to the point of withdrawal for 3 families.|||FOH scores per month|Fear of Hypoglycemia Measures|Standard Error|Mean
2613177|NCT02024477|Secondary|Fasting Lipid Profile LDL/HDL|ratio of LDL over HDL|Baseline, 6 and 12 weeks post saxagliptin||||ratio of LDL over HDL||Standard Deviation|Mean
2613178|NCT02024477|Secondary|Serum Endothelial Inflammatory Marker hsCRP||Baseline 6 and 12 weeks post saxagliptin||||mg/L||Standard Deviation|Mean
2613769|NCT02016716|Secondary|Percent Change From Baseline in N-Terminal Propeptide Type 1 Procollagen (P1NP)||Baseline, month 1, month 3, and month 6|All randomized participants who had a baseline and at least one postbaseline measurement for P1NP, and with available data at each time point.|||percent change||Inter-Quartile Range|Median
2613159|NCT02024750|Primary|Change in Parent Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention|Mean change in parent quality of life per month (slope), during and post-intervention. Parent quality of life is measured by the PedsQL Family Impact Module. Possible scores range from 0 to 100 with higher scores indicating better quality of life. Positive slopes reflect improving quality of life.|Up to 2 time points during the intervention (12 months) and up to 3 time points in the post-intervention period (12 months)|214 parents were analyzed for up to 2 time points during the intervention and up to 3 time points in the post-intervention period. Models include data to the point of withdrawal for 3 families.|||QOL scores per month|Quality of Life Measures|Standard Error|Mean
2613160|NCT02024750|Primary|Change in Child Quality of Life (QOL) for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention|Mean change in child quality of life per month (slope), during and post-intervention. Child quality of life is measured by the PedsQL Diabetes Module. Possible scores range from 0 to 100 with higher scores indicating better quality of life. Positive slopes reflect improving quality of life.|Up to 2 time points during the intervention (12 months) and up to 3 time points in the post-intervention period (12 months)|214 participants were analyzed for up to 2 time points during the intervention and up to 3 time points in the post-intervention period. Models include data to the point of withdrawal for 3 families.|||QOL scores per month|Quality of Life Measures|Standard Error|Mean
2613161|NCT02024750|Primary|Change in Hemoglobin A1c for Usual Care and Tailored Resources (Intervention) Arms, During and Post-Intervention|Mean change in A1c per month (slope), during and post-intervention.|Up to 5 time points during the intervention (12 months) and up to 4 time points in the post-intervention period (12 months)|214 participants were analyzed for up to 5 time points during the intervention and up to 4 time points in the post-intervention period. Models include data to the point of withdrawal for 3 families.|||Percent HbA1c per month|HbA1c Observations|Standard Error|Mean
2613162|NCT02024724|Primary|The Proportion of Subjects Reporting at Least 50% Overall Pain Relief|The number of subjects reporting a minimum of 50% pain relief after receiving the injection.|2 weeks|Subjects reported percent relief at 2 weeks from receiving the ultrasound guided injection.|||Participants|||Count of Participants
2613163|NCT02024698|Primary|Overall Satisfaction for Lens|"Subjective Assessment: Satisfaction overall at 1 Week wear for each pair when asked Overall, how satisfied was the subject with the study lenses, during the last week, with regards to: Overall? (Likert 1-4; 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied)"|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.|||participants|||Number
2613164|NCT02024698|Primary|Overall Sensation of Smoothness (Subjective Assessment)|"Subjective Assessment: Overall sensation of smoothness at 1 week wear for each pair when asked How would you rate the overall sensation of smoothness (deposit resistance) of the first study lenses, over the last week of wear? (Likert 1-5; 1=excellent, 2=good, 3=average, 4=below average, 5=poor)"|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.|||participants|||Number
2613165|NCT02024698|Primary|Eye Whiteness/Redness (Subjective Assessment)|Subjective Assessment: Eye Whiteness/Redness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= significant redness, 10=totally white)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.|||units on a scale||Standard Deviation|Mean
2613166|NCT02024698|Primary|Handling (Subjective Assessment)|Subjective Assessment: Handling on Insertion and Removal, Overall Handling for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very difficult, 10=very easy)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.|||units on a scale||Standard Deviation|Mean
2613167|NCT02024698|Primary|Dryness (Subjective Assessment)|Subjective Assessment: Dryness During Day, Dryness Prior to Removal, Overall Dryness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dry, 10=no dryness)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.|||units on a scale||Standard Deviation|Mean
2613168|NCT02024698|Primary|Vision Satisfaction (Subjective Assessment)|Subjective Assessment: Vision Satisfaction for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very unsatisfied, 10=very satisfied)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.|||units on a scale||Standard Deviation|Mean
2613169|NCT02024698|Primary|Vision Quality (Subjective Assessment)|Subjective Assessment: Visual quality on insertion at baseline for each pair using questionnaire and rated on subjective response scale (0-10; 0= clear vision, 10=perfectly sharp)|Baseline||||units on a scale||Standard Deviation|Mean
2613170|NCT02024698|Primary|Hydration (Subjective Assessment)|Subjective Assessment: Initial Hydration, Hydration During Day, Hydration Prior to Removal for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.|||units on a scale||Standard Deviation|Mean
2613171|NCT02024698|Primary|Hydration (Subjective Assessment)|Subjective Assessment of hydration on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)|Baseline||||units on a scale||Standard Deviation|Mean
2613172|NCT02024698|Primary|Comfort (Subjective Assessment)|Subjective Assessment: Insertion Comfort, Comfort During Day, Comfort Prior to Removal, Comfort Overall for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)|1 Week|One participant received etafilcon A twice which explains the uneven number of participants analyzed in the study results for week 1.|||units on a scale||Standard Deviation|Mean
2613173|NCT02024698|Primary|Comfort (Subjective Assessment)|Subjective Assessment of comfort on insertion at baseline for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)|Baseline||||units on a scale||Standard Deviation|Mean
2615709|NCT01998360|Secondary|Number of Participants With Adverse Events|Bleeding, hematoma, infection and other rare adverse events|1 month||||participants|||Number
2613179|NCT02024477|Primary|CD 34+ Cell Function|function of EPC cell as migration of CD34+ cells in response to SDF-1a ( 100 ng/mL). Results are expressed in fluorescence ratio between cells exposed to the chemotactic factor and cells exposed to chemo attractant-free media ( control) followed by lysis in presence of CyQuant GR dye.|Up to 12 weeks post saxagliptin Up to 12 weeks post saxagliptin: Visit 1 at Baseline, Visit 2 at 6 weeks, and Visit 3 at 12 weeks||||Ratio||Standard Deviation|Mean
2613180|NCT02024477|Primary|CD34+ Endothelial Progenitor Cells Number|We will use patient's peripheral blood derived CD34+ cells looking at number of CD34+ Endothelial Progenitor Cell as % of the total Mononuclear cell population. Post saxagliptin will be compared to pre saxagliptin measurement|Up to 12 weeks post saxagliptin||||% of Mononuclear Cells||Standard Deviation|Mean
2613181|NCT02024386|Secondary|Cardiac Output|Arterial blood samples will be obtained before, during, and after the VO2max exercise test in the hypobaric chamber at a simulated altitude of 15,000 feet. Exercise level will be increased every 3 minutes until test termination criteria are achieved. Samples will be obtained during the fifth minute of rest prior to exercise, during the third minute of each exercise level (referred to as stage below) and during the fifth minute post exercise. Cardiac output (CO) will be calculated using the Fick Principle: CO = V̇O2/(CaO2 - Cv̄O2) where CaO2 and Cv̄O2 represent the arterial and mixed venous oxygen content, respectively. CaO2 and CvO2 will be determined from analysis of the arterial blood samples using an IL GEM 4000 analyzer. VO2 will be reported as the final 30 secon average value of each stage. Subjects in the Riociguat cohorts will be tested prior to receiving drug and 90 minutes after receiving drug (midway through a three hour rest period between altitude exposures).|At rest, every 3 minutes during the exercise test and 5 minutes after each exercise test|Not all subjects performed the same number of exercise stages to achieve VO2max.|||L/min||Standard Deviation|Mean
2613182|NCT02024386|Secondary|Mean Work Rate at Exhaustion|Subject work rates at exhaustion (in watts) will be continuously monitored using an ergometer (exercise bicycle) during the VO2max exercise test in the hypobaric chamber at a simulated altitude of 15,000 feet. Exercise level will be increased every 3 minutes until test termination criteria are achieved. Measurements will be obtained at rest, every 3 minutes during the exercise test (referred to as a stage below) and at 5 minutes post exercise. Results will be reported as a 30 second average. Subjects in the Riociguat cohorts will be tested prior to receiving drug and 90 minutes after receiving drug (midway through a three hour rest period between altitude exposures).|At rest, every 3 minutes during the exercise test and 5 minutes after each exercise test|Not all subjects performed the same number of exercise stages to achieve VO2max.|||watts||Standard Deviation|Mean
2613183|NCT02024386|Secondary|Mean Ventilation Rate|Subject ventilation rates will be monitored continuously using a multi-channel A/D converter (PowerLab™) connected to a personal computer, using Chart™ software (ADInstruments, Colorado Springs, CO) during the VO2max exercise test in the hypobaric chamber at a simulated altitude of 15,000 feet. Exercise level will be increased every 3 minutes until test termination criteria are achieved. Measurements will be obtained at rest, every 3 minutes during the exercise test (referred to as a stage below) and at 5 minutes post exercise. Results will be reported as a 30 second average. Subjects in the Riociguat cohorts will be tested prior to receiving drug and 90 minutes after receiving drug (midway through a three hour rest period between altitude exposures).|At rest, every 3 minutes during the exercise test and 5 minutes after each exercise test|Not all subjects performed the same number of exercise stages to achieve VO2max.|||L/min||Standard Deviation|Mean
2613184|NCT02024386|Secondary|Mean Arterial Oxygen Saturation (SaO2)|Subject arterial oxygen saturation (SaO2) will be periodically monitored at fixed intervals via arterial blood gas measurements during the VO2max exercise test in the hypobaric chamber at a simulated altitude of 15,000 feet. Measurements will be obtained at rest, every 3 minutes during the exercise test (referred to as a stage below) and at 5 minutes post exercise. Results will be reported as a 30 second average. Subjects in the Riociguat cohorts will be tested prior to receiving drug and 90 minutes after receiving drug (midway through a three hour rest period between altitude exposures).|At rest, every 3 minutes during the exercise test and 5 minutes after each exercise test|Not all subjects performed the same number of exercise stages to achieve VO2max.|||% oxygen saturation||Standard Deviation|Mean
2613185|NCT02024386|Secondary|Mean Radial Arterial Pressure|Subject systemic arterial pressures will be continuously monitored via radial artery catheterization during the VO2max exercise test in the hypobaric chamber at a simulated altitude of 15,000 feet. Exercise level will be increased every 3 minutes until test termination criteria are achieved. Measurements will be obtained at rest, every 3 minutes during the exercise test (referred to as a stage below) and at 5 minutes post exercise. Results will be reported as a 30 second average. Subjects in the Riociguat cohorts will be tested prior to receiving drug and 90 minutes after receiving drug (midway through a three hour rest period between altitude exposures).|At rest, every 3 minutes during the exercise test and 5 minutes after each exercise test|Not all subjects performed the same number of exercise stages to achieve VO2max.|||mm Hg||Standard Deviation|Mean
2613186|NCT02024386|Primary|Mean Pulmonary Artery Pressure|Subject pulmonary artery pressures will be continuously monitored during the VO2max exercise test in the hypobaric chamber at a simulated altitude of 15,000 feet. Exercise level will be increased every 3 minutes until test termination criteria are achieved. Measurements will be obtained at rest, every 3 minutes during the exercise test (referred to as a stage below) and at 5 minutes post exercise. Results will be reported as a 30 second average. Subjects in the Riociguat cohorts will be tested prior to receiving drug and 90 minutes after receiving drug (midway through a three hour rest period between altitude exposures).|At rest, every 3 minutes during the exercise test and 5 minutes after each exercise test|Not all subjects performed the same number of exercise stages to achieve VO2max.|||mm Hg||Standard Deviation|Mean
2613187|NCT02024165|Primary|Fetal Heart Rate Interpretability|The Fetal Heart Rate (or FHR) of the electrode sensor will be compared to the FHR of the ultrasound when both are compared to the FSE. Percentage of time that signals are interpretable will be compared between devices|2 hours||||percentage of time the signals are inter||Standard Deviation|Mean
2613188|NCT02023983|Secondary|Complications Associated With the Puncture Site Requiring Treatment in 30 Days After Myocardial Infarction (MI)|Fischer´s exact test was used for comparison of qualitative variables between two groups. For comparison of quantitative variables we applied Mann-Whitney U test, respectively Student´s t-test (age). Normality of data was assessed with Shapiro-Wilk test. Values of p < 0.05 were considered as statistically significant.|30 days||||Participants|||Count of Participants
2613189|NCT02023983|Primary|Composite of Incidence of Death, Reinfarction, Unstable Angina Pectoris, Stroke, Unplanned Rehospitalization, Repeat Target Vessel Revascularization and Stent Thrombosis in 90 Days After Myocardial Infarction (MI)|Fischer´s exact test was used for comparison of qualitative variables between two groups. For comparison of quantitative variables we applied Mann-Whitney U test, respectively Student´s t-test (age). Normality of data was assessed with Shapiro-Wilk test. Values of p < 0.05 were considered as statistically significant.|90 days||||Participants|||Count of Participants
2613190|NCT02023944|Secondary|Multifactorial Memory Questionnaire (MMQ)|The MMQ is a measure constructed to reflect aspects of memory that are potentially amenable to clinical intervention. The scale consists of three subscales - memory contentment, memory ability, and memory strategy use. Higher scores indicate, respectively, greater contentment, ability, and strategy use. Minimum 0, maximum 80|Within 1 week of start of program||||units on a scale||Standard Deviation|Mean
2613191|NCT02023944|Primary|Knowledge of Memory Aging Questionnaire-Revised|"Measures laypersons' knowledge of memory changes in adulthood for research or educational purposes using true/false/don't know questions, with half of the questions pertaining to normal memory aging and the other half covering pathological memory deficits due to non-normative factors, such as dementia. Test-retest reliability and convergent and discriminant validity were established at adequate levels. Minimum value is 0, maximum value is 28, higher scores indicate better knowledge of memory aging."|Within 1 week of start of program||||units on a scale||Standard Deviation|Mean
2613192|NCT02023918|Secondary|Lipolysis|Treatment with pegvisomant is expected to alter lipolysis. To assess this investigators will do fasting and steady state stable isotope measurements prior to treatment with pegvisomant and at day 28 after treatment with pegvisomant.|28 days|Ra glycerol reported|||mg/kg/min||Standard Deviation|Mean
2613193|NCT02023918|Primary|Insulin Sensitivity|"Investigators will measure insulin sensitivity via hyperinsulinemic euglycemic clamp prior to the initiation of the study medication and then again at the end of the 28 days to evaluate the effect of pegvisomant on insulin sensitivity and reported as HOMA-IR.~HOMA-IR was derived from fasting insulin and fasting glucose by the calculation: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5"|28 days|Patients were compared after treatment to their own baseline|||units on a scale||Standard Deviation|Mean
2613194|NCT02023879|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 32, 36, 48, 72, 96, 120, 144, 168 On-Treatment Analysis in Open Label Extension Treatment Phase|Mean percent changes (and standard deviations) observed during the open-label extension period are provided.|Baseline, Week 32, 36, 48, 72, 96, 120, 144 and Week 168|Open-label extension population included all participants who received at least one dose or part of dose of Alirocumab during the open label extension period. Here, “number analyzed” signifies the number of participants evaluable for each specified time-point.|||percent change||Standard Deviation|Mean
2613195|NCT02023879|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.|||percent change||Standard Error|Least Squares Mean
2613196|NCT02023879|Secondary|Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.|||percent change||Standard Error|Least Squares Mean
2613197|NCT02023879|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2613198|NCT02023879|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2613199|NCT02023879|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
2613200|NCT02023879|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
2613201|NCT02023879|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2613202|NCT02023879|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2613203|NCT02023879|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) at Week 24 - On-treatment Analysis|Adjusted percentages at Week 24 from LOCF approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.|||percentage of participants|||Number
2613204|NCT02023879|Secondary|Percentage of Participants Achieving Calculated LDL-C< 70 mg/dL (<1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 from last observation carried forward (LOCF) approach including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percentage of participants|||Number
2613205|NCT02023879|Secondary|Percentage of Very High CV Risk Participants Achieving Calculated LDL-C< 70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C< 100 mg/dL (<2.59 mmol/L) at Week 24 - On-treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.|||percentage of participants|||Number
2613206|NCT02023879|Secondary|Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C <70 mg/dL (<1.81 mmol/L) or Moderate or High CV Risk Participants Achieving Calculated LDL-C <100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis|"Moderate CV risk: 10-year fatal cardiovascular disease (CVD) risk Systemic Coronary Risk Evaluation (SCORE) ≥1 and <5%.~High CV risk: 10-year fatal CVD risk SCORE ≥5% or moderate chronic kidney disease or type 1 or type 2 diabetes mellitus without target organ damage or familial hypercholesterolemia.~Very high CV risk: history of documented coronary heart disease, ischemic stroke, peripheral artery disease, transient ischemic attack, abdominal aortic aneurysm, or carotid artery occlusion >50% without symptoms; carotid endarterectomy or carotid artery stent procedure; renal artery stenosis, or renal artery stent procedure; or type 1 or type 2 diabetes mellitus with target organ damage.~Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included."|From Baseline to Week 24|ITT population.|||percentage of participants|||Number
2613207|NCT02023879|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
2613208|NCT02023879|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
2613209|NCT02023879|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.|||percent change||Standard Error|Least Squares Mean
2613210|NCT02023879|Secondary|Percent Change From Baseline in Total-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
2613211|NCT02023879|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.|||percent change||Standard Error|Least Squares Mean
2613212|NCT02023879|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
2613213|NCT02023879|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population. Number of participants analyzed = participants of the mITT population with available data at specified time-points.|||percent change||Standard Error|Least Squares Mean
2613214|NCT02023879|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population. Number of participants analyzed = participants of the ITT population with available data at specified time-points.|||percent change||Standard Error|Least Squares Mean
2613215|NCT02023879|Secondary|Percent Change From Baseline in Calculated LDL-C at Averaged Week 9 to 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) and assigning a weight of 0.25 for Week 9, 10, 11 and 12 time points.|From Baseline to Week 24|mITT population.|||percent change||Standard Error|Least Squares Mean
2613216|NCT02023879|Secondary|Percent Change From Baseline in Calculated LDL-C to Averaged Weeks 9 to 12 - ITT- Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment and assigning a weight of 0.25 for Week 9, 10, 11 and 12 time points.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
2613217|NCT02023879|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection).|From Baseline to Week 24|mITT population.|||percent change||Standard Error|Least Squares Mean
2613218|NCT02023879|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
2613219|NCT02023879|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population that included all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2615710|NCT01998360|Primary|Intraoperative Duration|The number of minutes required to perform the surgical procedure|1 hour||||Min||Inter-Quartile Range|Median
2613220|NCT02023879|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT Analysis)|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population that included all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2613221|NCT02023866|Secondary|Change From Baseline in Modified Lansky Play Performance Scale|"The investigator selected the 2 most preeminent symptoms for each participant during the screening visit from the following: myopathy, dystonia, ataxia, retarded motor development, reduced activities of daily living, and vision. The 2 symptoms were assessed at each subsequent study visit.~Reduced activities of daily living was assessed using the modified Lansky Play Performance Scale, completed by parents based on their child's activity in the past week, where 100=fully active; 90=minor restrictions in strenuous physical activity; 80=active, gets tired more quickly; 70=greater restriction of play, less time spent in play activity; 60=up and around, active play minimal; quieter activities; 50=lying around much of the day; no active playing, all quiet play and activities; 40=mainly in bed; quiet activities; 30=bedbound; needs assistance even for quiet play; 20=sleeps often; play limited to very passive activities; 10=doesn't play or get out of bed; 5=unresponsive 0=dead"|Baseline and Weeks 4, 8, 12, 16, 20, 24|Participants who received at least one dose of study drug (RP103) and had at least one post-baseline Lansky play performance scale assessment and for whom reduced activities of daily living was prespecified as a preeminent symptom and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2613222|NCT02023866|Secondary|Change From Baseline in Gross Motor Function|"The investigator selected the two most preeminent symptoms for each participant during the screening visit from the following: myopathy, dystonia, ataxia, retarded motor development, reduced activities of daily living, and vision. The 2 symptoms selected for each participant were then assessed at each subsequent study visit.~Retarded motor development was assessed using the Gross Motor Function Measure (GMFM)-88 which consists of 88 items scored on a scale of 0 to 3:~0: Does not initiate the task;~Initiates the task (completes < 10%);~Partially completes the task (10 to 99%);~Completes the task (100%).~The 88 items are grouped into five dimensions: 1) lying and rolling, 2) sitting, 3) crawling and kneeling, 4) standing, and 5) walking, running and jumping. Scores are expressed as a percentage of the maximum score for that dimension. The total score is the average of the 5 the percentage scores where higher scores indicate better performance."|Baseline and Weeks 4, 8, 12, 16, 20, 24|Participants who received at least one dose of study drug (RP103) and had at least one post-baseline gross motor function assessment and for whom retarded motor development was prespecified as a preeminent symptom and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2613223|NCT02023866|Secondary|Change From Baseline in Friedreich Ataxia Rating Scale|"The investigator selected the two most preeminent symptoms for each participant during the screening visit from the following: myopathy, dystonia, ataxia, retarded motor development, reduced activities of daily living, and vision. The 2 symptoms selected for each participant were then assessed at each subsequent study visit.~Ataxia was assessed using the Friedreich Ataxia Rating Scale (FARS). FARS comprises a functional ataxia staging score of overall mobility (score 0 to 6), an assessment of the activities of daily living (ADL) (score 0 to 36) and a neurological assessment (score from 0 to 117) which is composed of bulbar (score 0-11), upper limb (score 0- 36) and lower limb (score 0-16), peripheral nerve (score 0-26) and upright stability/gait (score 0-28). The scores were summed to calculate the total score which ranges from 0 to 159. A higher score indicates a greater level of disability."|Baseline and Weeks 4, 8, 12, 16, 20, 24|Participants who received at least one dose of study drug (RP103) and had at least one post-baseline ataxia assessment and for whom ataxia was prespecified as a preeminent symptom and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2613224|NCT02023866|Secondary|Change From Baseline in Barry-Albright Dystonia Scale Total Score|"The investigator selected the two most preeminent symptoms for each participant during the screening visit from the following: myopathy, dystonia, ataxia, retarded motor development, reduced activities of daily living, and vision. The 2 symptoms selected for each participant were then assessed at each subsequent study visit.~Dystonia symptoms were assessed using the Barry-Albright Dystonia Scale for Dystonia. Participants were assessed for dystonia in each of the following regions: eyes, mouth, neck, trunk, and each upper and lower extremity (8 body regions) on a scale from 0 (absent) to 4 (severe symptoms). The individual scores were summed to calculate the total score which ranges from 0 (dystonia absent) to 32 (severe dystonia)."|Baseline and Weeks 4, 8, 12, 16, 20, 24|Participants who received at least one dose of study drug (RP103) and had at least one post-baseline dystonia assessment and for whom dystonia was prespecified as a preeminent symptom and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2613225|NCT02023866|Secondary|Change From Baseline in Jamar Dynamometer Hand Strength|"The investigator selected the two most preeminent symptoms for each participant during the screening visit from the following: myopathy, dystonia, ataxia, retarded motor development, reduced activities of daily living, and vision. The 2 symptoms selected for each participant were then assessed at each subsequent study visit.~Myopathy was assessed using standard grip strength evaluation, which measures hand strength in both hands using a Jamar dynamometer."|Baseline and Weeks 4, 8, 12, 16, 20, 24|Participants who received at least one dose of study drug (RP103) and had at least one post-baseline Jamar hand strength assessment and for whom myopathy was prespecified as a preeminent symptom and with available data at each time point.|||kg||Standard Deviation|Mean
2613226|NCT02023866|Secondary|Change From Baseline in 6 Minute Walk Test|"The investigator selected the two most preeminent symptoms for each participant during the screening visit from the following: Myopathy, dystonia, ataxia, retarded motor development, reduced activities of daily living, and vision. The 2 symptoms selected for each participant were then assessed at each subsequent study visit.~Myopathy was assessed using the 6 minute walk test, which measures the distance walked in a 6 minute walk test."|Baseline and Weeks 4, 8, 12, 16, 20, 24|Participants who received at least one dose of study drug (RP103) and had at least one post-baseline 6 minute walk test assessment and for whom myopathy was prespecified as a preeminent symptom and with available data at each time point.|||meters||Standard Deviation|Mean
2613227|NCT02023866|Secondary|Change From Baseline in Lactic Acid||Baseline and Weeks 4, 8, 12, 16, 20, 24|PD analysis set participants with available data at each time point.|||mmol/L||Standard Deviation|Mean
2613229|NCT02023866|Secondary|Change From Baseline in Glutathione||Baseline and Weeks 4, 8, 12, 16, 20, 24|The pharmacodynamic (PD) analysis set included all participants who received at least one dose of study drug and had at least one post-baseline PD assessment. Participants with available data at each time point are included in the analysis.|||µmol/L||Standard Deviation|Mean
2613230|NCT02023866|Primary|Change From Baseline in Newcastle Paediatric Mitochondrial Disease Scale (NPMDS) Sections I-IV|"The NPMDS evaluates the progression of mitochondrial disease in pediatric patients in 4 domains:~I - Current Function (vision, hearing, communication, feeding, and mobility) with scores ranging from 0 to 21; II -System Specific Involvement (seizures, encephalopathy, bleeding diathesis or coagulation defects, gastrointestinal, endocrine, respiratory, cardiovascular, renal, liver, and blood) with scores ranging from 0 to 30.~III - Current Clinical Assessment (growth and development over past 6 months, vision, strabismus and eye movement, myopathy, ataxia, pyramidal, extrapyramidal, and neuropathy) with scores ranging from 0 to 28; and IV - Quality of Life with scores ranging from 0 to 25. For sections I-III, higher scores reflect more severe disease. For Section IV, a higher score reflects a lower quality of life."|Baseline through Week 24|Completers Analysis Set included all participants who received at least one dose of study drug (RP103) with at least one post-baseline NPMDS assessment and an evaluable Week 24 NPMDS assessment within the protocol specified window.|||units on a scale||Standard Deviation|Mean
2613231|NCT02023801|Post-Hoc|Subjects With Amenorrhea at 12 Months|Amenorrhea at 12 Months- Number of Subjects experiencing no menstrual bleeding|12 months|Protocol Intent-to-treat|||participants|||Number
2613232|NCT02023801|Secondary|Procedure Time|Procedure time defined as time from insertion of the Disposable Handpiece to the time of removal|< 1 hour|Subjects completing treatment|||Minutes||Standard Deviation|Mean
2613233|NCT02023801|Primary|Reduction in Menstrual Blood Loss to Normal Levels at 12 Months|Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of <=75.|12 Months|Protocol Intent-to-treat population (all subjects in whom the experimental device was attempted to be placed.)|||participants|||Number
2613234|NCT02023697|Other Pre-specified|Number of Participants With Change in Analgesic Use From Baseline to Worst Status Post-Baseline|Analgesic use in this study were captured via two methods: Analgesic concomitant medication case report form, where the physician records the analgesic medication prescribed to manage pain; 24 hour analgesic consumption case report form, in which all analgesic medication taken in the last 24 hours.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)||||Participants|||Count of Participants
2613235|NCT02023697|Secondary|Number of Participants With Treatment-Emergent Adverse Events|Treatment-emergent adverse events are events starting or worsening from the initiation of treatment until 30 days after the last administration of radium-223 dichloride. The intensity of an AE is classified according to the grades specified by the National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE).|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Safety Analysis Set|||Participants|||Count of Participants
2613236|NCT02023697|Secondary|Time to Pain Progression - Three Dose Groups as Randomized|The time to pain progression is defined for each applicable baseline for applicable participants as the time (in days) from the respective baseline until occurrence of the first post-baseline pain progression event.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||months||80% Confidence Interval|Median
2613237|NCT02023697|Secondary|Number of Participants With a Pain Progression Event - Three Dose Groups as Randomized|Pain progression is defined for each baseline in participants evaluable for pain progression at the applicable baseline, i.e., participants with a WPS of ≤ 7 at the respective baseline assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||Participants|||Count of Participants
2613238|NCT02023697|Secondary|Time to Pain Progression - Extended Dose vs. Standard Dose|The time to pain progression is defined for each applicable baseline for applicable participants as the time (in days) from the respective baseline until occurrence of the first post-baseline pain progression event.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||months||80% Confidence Interval|Median
2613239|NCT02023697|Secondary|Number of Participants With a Pain Progression Event - Extended Dose vs. Standard Dose|Pain progression is defined for each baseline in participants evaluable for pain progression at the applicable baseline, i.e., participants with a WPS of ≤ 7 at the respective baseline assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||Participants|||Count of Participants
2613240|NCT02023697|Secondary|Time to Pain Progression - High Dose vs. Standard Dose|The time to pain progression is defined for each applicable baseline for applicable participants as the time (in days) from the respective baseline until occurrence of the first post-baseline pain progression event.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||months||80% Confidence Interval|Median
2613251|NCT02023697|Secondary|Number of Participants With a Radiological Progression Event-Free - Three Dose Groups as Randomized|Radiological progression of soft tissue disease is determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Magnetic resonance imaging (MRI) or Computed tomography (CT) scans. Radiological progression of osseous disease is determined according to adapted Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria based on whole body technetium-99 bone scans.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||Participants|||Count of Participants
2613241|NCT02023697|Secondary|Number of Participants With a Pain Progression Event - High Dose vs. Standard Dose|"Participants were divided in 3 groups according to baseline pain evaluation: asymptomatic subjects (WPS 0 to < 1 at baseline); mildly symptomatic subjects (WPS 1-3 at baseline); and symptomatic subjects with WPS > 3 and ≤ 7 at baseline). Pain progression was defined as the occurrence of a pain increase of 2 or more points in the average (i.e., average of 7-day assessments) worst pain in 24 hours score from baseline observed at 2 consecutive evaluations ≥ 4 weeks apart. Participants with insufficient applicable baseline assessments or without adequate post-baseline assessments were to be censored at the applicable baseline date."|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||Participants|||Count of Participants
2613242|NCT02023697|Secondary|Timepoint Pain Improvement Rate - Extended Dose vs. Standard Dose|Timepoint pain improvement rate is defined as the proportion of participants with a 30% and 2-point decrease in Worst pain score (WPS) from baseline over 2 consecutive assessment periods conducted at least 4 weeks apart among participants with a WPS score ≥ 4 at baseline.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||percentage||80% Confidence Interval|Number
2613243|NCT02023697|Secondary|Timepoint Pain Improvement Rate - Three Dose Groups as Randomized|Timepoint pain improvement rate is defined as the proportion of participants with a 30% and 2-point decrease in Worst pain score (WPS) from baseline over 2 consecutive assessment periods conducted at least 4 weeks apart among participants with a WPS score ≥ 4 at baseline.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||percentage||80% Confidence Interval|Number
2613244|NCT02023697|Secondary|Time to Radiological Progression - Three Dose Groups as Randomized|Time to radiological progression is defined as the time in days from the applicable start date to the date of subsequent radiological progression. Participants without radiological progression as of database cut-off date, whether or not surviving, were censored at the last radiological progression assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||months||80% Confidence Interval|Median
2613245|NCT02023697|Secondary|Number of Participants With a Radiological Progression Event - Three Dose Groups as Randomized|Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||Participants|||Count of Participants
2613246|NCT02023697|Secondary|Time to Radiological Progression - Extended Dose vs. Standard Dose|Time to radiological progression is defined as the time in days from the applicable start date to the date of subsequent radiological progression. Participants without radiological progression as of database cut-off date, whether or not surviving, were censored at the last radiological progression assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||months||80% Confidence Interval|Median
2613247|NCT02023697|Secondary|Number of Participants With a Radiological Progression Event - Extended Dose vs. Standard Dose|Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||Participants|||Count of Participants
2613248|NCT02023697|Secondary|Time to Radiological Progression - High Dose vs. Standard Dose|Time to radiological progression is defined as the time in days from the applicable start date to the date of subsequent radiological progression. Participants without radiological progression as of database cut-off date, whether or not surviving, were censored at the last radiological progression assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||months||80% Confidence Interval|Median
2613249|NCT02023697|Secondary|Number of Participants With a Radiological Progression Event - High Dose vs. Standard Dose|Radiological progression of soft tissue disease is determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Magnetic resonance imaging (MRI) or Computed tomography (CT) scans. Radiological progression of osseous disease is determined according to adapted Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria based on whole body technetium-99 bone scans.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||Participants|||Count of Participants
2613250|NCT02023697|Secondary|Radiological Progression Free Survival - Three Dose Groups as Randomized|Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||months||80% Confidence Interval|Median
2613252|NCT02023697|Secondary|Radiological Progression Free Survival - Extended Dose vs. Standard Dose|Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Baseline is randomization date|||months||80% Confidence Interval|Median
2613253|NCT02023697|Secondary|Number of Participants With a Radiological Progression Event-Free - Extended Dose vs. Standard Dose|Radiological progression of soft tissue disease is determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Magnetic resonance imaging (MRI) or Computed tomography (CT) scans. Radiological progression of osseous disease is determined according to adapted PCWG2 criteria based on whole body technetium-99 bone scans.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Baseline is randomization date|||Participants|||Count of Participants
2613254|NCT02023697|Secondary|Radiological Progression Free Survival - High Dose vs. Standard Dose|Radiological progression free survival is defined as the time in days from the applicable start date to the date of subsequent radiological disease progression or death from any cause (if death occurs before such progression). Participants not experiencing death or radiological disease progression as of database cut-off were censored at the last radiological disease progression assessment.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||months||80% Confidence Interval|Median
2613255|NCT02023697|Secondary|Number of Participants With a Radiological Progression Event-Free - High Dose vs. Standard Dose|Radiological progression of soft tissue disease is determined according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Magnetic resonance imaging (MRI) or computed tomography (CT) scans. Radiological progression of osseous disease is determined according to adapted PCWG2 criteria based on whole body technetium-99 bone scans. Radiological bone progression is determined if at least one of the following criteria is met: The first bone scan with ≥2 new lesions compared to baseline is observed <12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); or The first bone scan with ≥2 new lesions compared to baseline is observed ≥12 weeks from randomization and the new lesions are verified on the next bone scan ≥6 weeks later (a total of ≥2 new lesions compared to baseline).|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||Participants|||Count of Participants
2613256|NCT02023697|Secondary|Time to First Symptomatic Skeletal Event - Three Dose Groups as Randomized|Time to first SSE is defined as the time in days from the applicable start date to the first SSE on or following the start date.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||months||80% Confidence Interval|Median
2613257|NCT02023697|Secondary|Number of Participants With First Symptomatic Skeletal Event - Three Dose Groups as Randomized|Symptomatic skeletal event (SSE) is defined as follows: The use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; The occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); The occurrence of spinal cord compression; A tumor related orthopedic surgical intervention.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||Participants|||Count of Participants
2613258|NCT02023697|Secondary|Time to First Symptomatic Skeletal Event - Extended Dose vs. Standard Dose|Time to first SSE is defined as the time in days from the applicable start date to the first SSE on or following the start date.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||months||80% Confidence Interval|Median
2613259|NCT02023697|Secondary|Number of Participants With First Symptomatic Skeletal Event - Extended Dose vs. Standard Dose|Symptomatic skeletal event (SSE) is defined as follows: The use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; The occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); The occurrence of spinal cord compression; A tumor related orthopedic surgical intervention.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||Participants|||Count of Participants
2613260|NCT02023697|Secondary|Time to First Symptomatic Skeletal Event - High Dose vs. Standard Dose|Time to first SSE is defined as the time in days from the applicable start date to the first SSE on or following the start date.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||months||80% Confidence Interval|Median
2613261|NCT02023697|Secondary|Number of Participants With First Symptomatic Skeletal Event - High Dose vs. Standard Dose|Symptomatic skeletal event (SSE) is defined as follows: The use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; The occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); The occurrence of spinal cord compression; A tumor related orthopedic surgical intervention.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||Participants|||Count of Participants
2614247|NCT02013674|Secondary|Difference Between the Regional Left Ventricular Wall Thickening|As determined by Computed Tomography Scan|Baseline, Month 12|Data were not available to perform the statistical analyses as described in the protocol for this outcome.||||||
2613262|NCT02023697|Secondary|Overall Survival Event - Three Dose Groups as Randomized|Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||months||80% Confidence Interval|Median
2613263|NCT02023697|Secondary|Number of Participants With an Overall Survival - Three Dose Groups As Randomized|Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||Participants|||Count of Participants
2613264|NCT02023697|Secondary|Overall Survival - Extended Dose vs. Standard Dose|Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||months||80% Confidence Interval|Median
2613265|NCT02023697|Secondary|Number of Participants With an Overall Survival Event - Extended Dose vs. Standard Dose|Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||Participants|||Count of Participants
2613266|NCT02023697|Secondary|Overall Survival - High Dose vs. Standard Dose|Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||months||80% Confidence Interval|Median
2613267|NCT02023697|Secondary|Number of Participants With an Overall Survival Event - High Dose vs. Standard Dose|Overall survival was defined as the time in days from the applicable start date to the date of death due to any cause. Participants who were still alive or who were lost to survival follow-up as of database cut-off date were to be censored at the last known alive date on or prior to database cut-off date.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT. Data from Arm C are truncated at 7th dose date when pooling with Arm A.|||Participants|||Count of Participants
2613268|NCT02023697|Primary|Symptomatic Skeletal Event Free Survival - Three Dose Groups As Randomized|Symptomatic skeletal event (SSE) is defined as follows: The use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; The occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); The occurrence of spinal cord compression; A tumor related orthopedic surgical intervention.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||months||80% Confidence Interval|Median
2613269|NCT02023697|Primary|Number of Participants With an Event Defining SSE Free Survival - Three Dose Groups As Randomized|Symptomatic skeletal event (SSE) free survival is based on the following events: the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); the occurrence of spinal cord compression; a tumor related orthopedic surgical intervention, and death.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|ITT|||Participants|||Count of Participants
2613270|NCT02023697|Primary|Symptomatic Skeletal Event-Free Survival - Extended Dose vs. Standard Dose|In this evaluation - Comparison 2, SSE-FS from 6th dose is defined in W24 participants as the time from Week 24 baseline (the 6th dose date) to an SSE or death, whichever occurs first.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24)|||months||80% Confidence Interval|Median
2613271|NCT02023697|Primary|Number of Participants With an Event Defining SSE Free Survival - Extended Dose vs. Standard Dose|Symptomatic skeletal event (SSE) free survival is based on the following events: the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); the occurrence of spinal cord compression; a tumor related orthopedic surgical intervention, and death. In this evaluation - Comparison 2, SSE-FS from 6th dose is defined in W24 participants as the time from Week 24 baseline (the 6th dose date) to an SSE or death, whichever occurs first.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Week 24 (W24): All ITT participants in Arm A (standard dose) and Arm C (extended dosing) treated with radium-223 dichloride and eligible for further treatment at W24 (i.e., 7th injection). All participants who received 6 doses from Arm A and participants who received >=6 doses from Arm C were included .|||Participants|||Count of Participants
2613288|NCT02023125|Secondary|t1/2 of RO5468924: Group 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||hours||Standard Deviation|Mean
2613272|NCT02023697|Primary|Symptomatic Skeletal Event-Free Survival - High Dose vs. Standard Dose|In this evaluation - comparison 1, SSE-FS following randomization is defined in ITT participants as the time from randomization to an SSE or death, whichever occurs first.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Intent-to-treat (ITT): All randomized participants. Data from Arm C are truncated at 7th dose date when pooling with Arm A, therefore Pooled Arm A+C included 261 participants.|||months||80% Confidence Interval|Median
2613273|NCT02023697|Primary|Number of Participants With an Event Defining SSE Free Survival - High Dose vs. Standard Dose|Symptomatic skeletal event (SSE) free survival is based on the following events: the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms; the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral); the occurrence of spinal cord compression; a tumor related orthopedic surgical intervention, and death. In this evaluation - comparison 1, SSE-FS following randomization is defined in ITT participants as the time from randomization to an SSE or death, whichever occurs first.|From randomization to 135 SSE-FS events have been observed in comparison 1 or 75 SSE-FS events observed in comparison 2, whichever occurred last (approximately 36 months from first patient randomization)|Intent-to-treat (ITT): All randomized participants. Data from Arm C are truncated at 7th dose date when pooling with Arm A, therefore Pooled Arm A+C included 261 participants.|||Participants|||Count of Participants
2613274|NCT02023515|Secondary|Decrease in Stress|Stress was measured by the Perceived Stress Scale (PSS). This scale measures stress on a scale of 0 to 40 points. The results are reported as a total score on the scale. Higher numbers indicate more stress than lower numbers.|PSS change from baseline to 20 weeks||||units on a scale||90% Confidence Interval|Mean
2613275|NCT02023515|Primary|Weight Loss|Weight change from baseline to 20 weeks|Weight change from baseline to 20 weeks||||kg||Standard Deviation|Mean
2613276|NCT02023268|Primary|Global Ocular Staining (With Oxford Scale - Ranges : 0-15)|"Change from Baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)~Global Ocular Staining With the Oxford Scale measured surface damage to treated eyes(by T2762 or vismed)."|Baseline and Day 35|14 patients with major protocol deviations were excluded of the analysed population.|||score on a scale||Standard Deviation|Mean
2613277|NCT02023242|Secondary|Unmedicated IOP </= 18 mmHg at 12 Months|Percentage of subjects with IOP </= 18 mmHg and without the use of ocular hypotensive medications at 12 months|12 months|Intent-to-Treat (ITT)|||percentage of participants|||Number
2613278|NCT02023242|Secondary|Unmedicated IOP </= 19 mmHg at 24 Months|Percentage of subjects with IOP </= 19 mmHg and without the use of ocular hypotensive medications at 24 months|24 Months|Intent-to-Treat (ITT). Number of Participants Analyzed at 24Months in the Hydrus Microstent arm are different than at 12 Months due to patients lost to follow-up|||percentage of participants|||Number
2613279|NCT02023242|Secondary|Mean Medication Use at 12 and 24 Months|The mean medication use at 12 and 24 months|12 & 24 Months|Intent-to-Treat (ITT). Number of Participants Analyzed at 24 Months in the Hydrus Microstent arm are different than at 12 Months due to patients lost to follow-up|||number of medications||Standard Deviation|Mean
2613280|NCT02023242|Secondary|The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months|The percentage of subjects who are not using ocular hypotensive medications at 12 and 24 months|12 & 24 Months|Intent-to-Treat (ITT). Number of Participants Analyzed at 24 Months in the Hydrus Microstent arm are different than at 12 Months due to patients lost to follow-up|||percentage of participants|||Number
2613281|NCT02023242|Primary|Unmedicated IOP </= 19 mmHg at 12 Months|Percentage of subjects with IOP </= 19 mmHg and without the use of ocular hypotensive medications at 12 months|12 months|Intent-to-Treat (ITT)|||percentage of participants|||Number
2613282|NCT02023151|Secondary|Changes in Syk Expression|Change in syk expression. Syk is a signaling molecule that is the first downstream event in IgE receptor activation of basophils.|baseline and 26 weeks||||fold change||Standard Deviation|Mean
2613283|NCT02023151|Primary|Changes in the Peripheral Blood Basophil Response to Crosslinking Anti-IgE Ab|Data will be analyzed for the fold change in the in vitro anti-IgE-mediated histamine release response|baseline and 26 weeks||||Fold change in basophil Syk expression||Standard Deviation|Mean
2613284|NCT02023125|Secondary|Vz/F for Alectinib: Group 2|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||Liters||Standard Deviation|Mean
2613285|NCT02023125|Secondary|Apparent Volume of Distribution (Vz/F) for Alectinib: Group 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||Liters||Standard Deviation|Mean
2613286|NCT02023125|Secondary|CL/F for Alectinib: Group 2|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||L/h||Standard Deviation|Mean
2613287|NCT02023125|Secondary|Apparent Oral Clearance (CL/F) for Alectinib: Group 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||Liters per hour (L/h)||Standard Deviation|Mean
2613342|NCT02022085|Secondary|Time to Perform Surgery|Time of first incision to time of last suture|Visit 2 (Surgery)|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.|||Minutes||Standard Deviation|Mean
2613289|NCT02023125|Secondary|t1/2 of RO5468924: Group 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Group 1]|||hours||Standard Deviation|Mean
2613290|NCT02023125|Secondary|t1/2 of Alectinib: Group 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||hours||Standard Deviation|Mean
2613291|NCT02023125|Secondary|Terminal Half-life (t1/2) of Alectinib: Group 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||hours||Standard Deviation|Mean
2613292|NCT02023125|Secondary|Tmax of RO5468924: Group 2|RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||hours||Full Range|Median
2613293|NCT02023125|Secondary|Tmax of RO5468924: Group 1|RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||hours||Full Range|Median
2613294|NCT02023125|Secondary|Tmax of Alectinib: Group 2||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||hours||Full Range|Median
2613295|NCT02023125|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib: Group 1||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||hours||Full Range|Median
2613296|NCT02023125|Secondary|AUClast of RO5468924: Group 2|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||h*ng/mL||Standard Deviation|Mean
2613297|NCT02023125|Secondary|AUClast of RO5468924: Group 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||h*ng/mL||Standard Deviation|Mean
2613298|NCT02023125|Secondary|AUClast of Alectinib: Group 2|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||h*ng/mL||Standard Deviation|Mean
2613299|NCT02023125|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Alectinib: Group 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||h*ng/mL||Standard Deviation|Mean
2613300|NCT02023125|Secondary|Metabolite/Parent Ratio for AUC0-inf: Group 2|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib. The ratio is molecular weight adjusted.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||ratio||Standard Deviation|Geometric Mean
2613301|NCT02023125|Secondary|Metabolite/Parent Ratio for AUC0-inf: Group 1|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib. The ratio is molecular weight adjusted.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||ratio||Standard Deviation|Geometric Mean
2613302|NCT02023125|Secondary|AUC0-inf of RO5468924: Group 2|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||h*ng/mL||Standard Deviation|Mean
2613303|NCT02023125|Secondary|AUC0-inf of RO5468924: Group 1|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||h*ng/mL||Standard Deviation|Mean
2613304|NCT02023125|Secondary|Cmax of RO5468924: Group 2|RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||ng/mL||Standard Deviation|Mean
2613305|NCT02023125|Secondary|Cmax of RO5468924: Group 1|RO5468924 is M4 metabolite of alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||ng/mL||Standard Deviation|Mean
2613306|NCT02023125|Primary|AUC0-inf of Alectinib: Group 2|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2]|||h*ng/mL||Standard Deviation|Mean
2613307|NCT02023125|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of Alectinib: Group 1|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|PK Analysis Population [Group 1]|||hours*nanograms per milliliter (h*ng/mL)||Standard Deviation|Mean
2613308|NCT02023125|Primary|Cmax of Alectinib: Group 2||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment period|PK Analysis Population [Group 2] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.|||ng/mL||Standard Deviation|Mean
2613309|NCT02023125|Primary|Maximum Observed Plasma Concentration (Cmax) of Alectinib: Group 1||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm|Pharmacokinetic (PK) Analysis Population [Group 1] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2613310|NCT02023112|Secondary|Percentage of Participants With Post-treatment Relapse Within Different Subpopulations|"The percentage of participants with relapse by post-treatment Week 12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis.~Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm."|within 12 weeks after the last dose of study drug|ITT population: all randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment; n=participants in given subpopulation.|||percentage of participants|||Number
2613311|NCT02023112|Secondary|Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations|"The percentage of participants with on-treatment virologic failure in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis.~On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment)."|12 or 16 weeks (end of treatment period)|ITT population: all randomized participants who received at least 1 dose of study drug; n=participants in given subpopulation.|||percentage of participants|||Number
2613312|NCT02023112|Secondary|Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations|The percentage of participants with SVR12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; noncirrhotic participants who relapsed after prior IFN-based therapy (relapsers); noncirrhotic T-exp participants who were non-responders to prior IFN-based therapy; noncirrhotic T-exp participants who were intolerant to IFN-based therapy; participants with compensated cirrhosis.|12 weeks after last dose of study drug|ITT population: all randomized participants who received at least 1 dose of study drug; n=participants in given subpopulation.|||percentage of participants||95% Confidence Interval|Number
2613313|NCT02023112|Secondary|Percentage of Participants With Post-treatment Relapse|Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm.|within 12 weeks after the last dose of study drug|Primary efficacy population: all treatment-naïve, noncirrhotic participants in the ITT population (all randomized participants who received at least 1 dose of study drug) with HCV RNA < LLOQ at the final treatment visit who completed treatment.|||percentage of participants|||Number
2613314|NCT02023112|Secondary|Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period|On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment).|12 or 16 weeks (end of treatment period)|Primary efficacy population: all treatment-naïve, noncirrhotic participants in the ITT population (all randomized participants who received at least 1 dose of study drug).|||percentage of participants|||Number
2613315|NCT02023112|Primary|Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after last dose of study drug|Primary efficacy population: all treatment-naïve, noncirrhotic participants in the intent-to-treat (ITT) population (all randomized participants who received at least 1 dose of study drug).|||percentage of participants|||Number
2613316|NCT02023099|Secondary|Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Sustained Virologic Response 12 Weeks Post-Treatment, by Subpopulation|Sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug for all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 in the following subpopulations: noncirrhotic T-naïve participants with a high BL viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-BT; noncirrhotic T-naïve participants with low BL viral load (HCV RNA < 100,000 IU/mL); noncirrhotic T-naïve participants who are ineligible for IFN-BT; noncirrhotic T-exp participants who relapsed after prior IFN-BT; noncirrhotic T-exp participants who were nonresponders to prior IFN-BT; noncirrhotic T-exp participants who were intolerant to IFN-BT. The 95% confidence interval was calculated using the Wilson's score method.|12 weeks after last dose of study drug|ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A); n=number of participants in the given subpopulation (among noncirrhotic participants, a single participant could potentially be included in more than 1 subpopulation).|||percentage of participants||95% Confidence Interval|Number
2613399|NCT02021643|Secondary|Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2613317|NCT02023099|Secondary|Percentage of Participants in the Active Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment|Sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug for all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and for all enrolled participants with compensated cirrhosis who received at least one dose of open-label ABT-450/r/ABT-267. The 95% confidence interval was calculated using the Wilson's score method.|12 weeks after last dose of study drug|ITT population: all randomized/enrolled participants who received at least 1 dose of DB study drugs in Substudy 1 (Substudy 1 ITT population) or at least 1 dose of OL study drugs in Substudy 2 (Substudy 2 ITT population).|||percentage of participants||95% Confidence Interval|Number
2613318|NCT02023099|Secondary|Percentage of Participants in Substudy 1 Arm A Active Treatment Group With Post-treatment Relapse, by Subpopulation|"Post-treatment relapse among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and completed treatment, in the following subpopulations: noncirrhotic treatment-naïve (T-naïve) participants with a high baseline (BL) viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-based therapy (IFN-BT), a low BL viral load (HCV RNA < 100,000 IU/mL), or who are ineligible for IFN-BT; noncirrhotic treatment-experienced (T-exp) participants who relapsed after prior IFN-BT, who were nonresponders to prior IFN-BT, or who were intolerant to IFN-BT.~Relapse was defined as confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) between the final treatment visit and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA < LLOQ at the final treatment visit and at least one post-treatment HCV RNA value. The 95% confidence interval was calculated using the Wilson's score method."|within 12 weeks after last dose of study drug|ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A) and completed treatment; n=number of participants in the given subpopulation (among noncirrhotic participants, a single participant could potentially be included in more than 1 subpopulation).|||percentage of participants||95% Confidence Interval|Number
2613319|NCT02023099|Secondary|Percentage of Participants in the Active Treatment Group With Post-treatment Relapse|Post-treatment relapse among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and completed treatment, and all enrolled participants with compensated cirrhosis who received at least one dose of OL ABT-450/r/ABT-267 and completed treatment. Relapse was defined as confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) between the final treatment visit and 12 weeks after the last dose of study drugs among participants completing treatment and with HCV RNA < LLOQ at the final treatment visit and at least one post-treatment HCV RNA value. The 95% confidence interval was calculated using the Wilson's score method.|within 12 weeks after last dose of study drug|ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A) or at least 1 dose of OL study drugs in Substudy 2 (Substudy 2 ITT population).|||percentage of participants||95% Confidence Interval|Number
2613320|NCT02023099|Secondary|Percentage of Participants in the Substudy 1 Arm A Active Treatment Group With On-treatment Virologic Failure During Treatment, by Subpopulation|On-treatment virologic failure among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 in the following subpopulations: noncirrhotic treatment-naïve (T-naïve) participants with a high baseline (BL) viral load (HCV RNA ≥ 100,000 IU/mL) who are eligible for IFN-based therapy (IFN-BT), a low viral load (HCV RNA < 100,000 IU/mL), or who are ineligible for IFN-BT; noncirrhotic treatment-experienced (T-exp) participants who relapsed after prior IFN-BT, who were nonresponders to prior IFN-BT, or who were intolerant to IFN-BT. On-treatment virologic failure is defined in Outcome measure 2. The 95% confidence interval was calculated using the Wilson's score method.|up to 12 weeks|ITT population: all randomized/enrolled participants who received at least 1 dose of active DB study drugs in Substudy 1 (Substudy 1 ITT population, Arm A).|||percentage of participants||95% Confidence Interval|Number
2613321|NCT02023099|Secondary|Percentage of Participants in the Active Treatment Group With On-treatment Virologic Failure During Treatment|"On-treatment virologic failure among all randomized non-cirrhotic participants who received at least one dose of DB ABT-450/r/ABT-267 and all enrolled participants with compensated cirrhosis who received at least one dose of OL ABT-450/r/ABT-267. On-treatment virologic failure is defined as the occurrence of at least one of the following:~confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) at any point during treatment after HCV RNA < LLOQ (rebound), or~confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) at any time point during treatment (rebound), or~HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment (failure to suppress).~The 95% confidence interval was calculated using the Wilson's score method."|up to 12 weeks|Intent-to-treat (ITT) population: randomized/enrolled participants who received at least 1 dose of DB study drugs in Substudy 1 (Substudy 1 ITT population) and completed treatment; n=number of participants in the given subpopulation (among noncirrhotic participants, a single participant could potentially be included in more than 1 subpopulation).|||percentage of participants||95% Confidence Interval|Number
2613322|NCT02023099|Primary|Percentage of Non-cirrhotic Treatment-Naïve Participants Who Are Eligible for Interferon (IFN)-Based Therapy and Who Have High Viral Load in the DB Active Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment|The percentage noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline (HCV RNA ≥ 100,000 IU/mL) in the DB active treatment group with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of active study drug (SVR12). Among noncirrhotic treatment-naïve participants who were eligible for IFN-based therapy and who had high viral load at baseline, superiority of Arm A to a clinically relevant threshold based on historical SVR rate with telaprevir plus pegylated interferon alpha/ribavirin (pegIFN/RBV) in treatment-naïve, non-cirrhotic patients with high viral load; the lower bound of 95% confidence interval (LCB) had to exceed 63% to achieve superiority. The 95% confidence interval was calculated using the normal approximation to the binomial distribution.|12 weeks after the last dose of study drug|Primary Efficacy Population: randomized non-cirrhotic treatment-naïve participants who are eligible for interferon-based therapy and who have high viral load and received at least one dose of double-blind ABT-450/r/ABT-267.|||percentage of participants||95% Confidence Interval|Number
2613323|NCT02022826|Secondary|Agreement Between Gastric Emptying Time of SmartPill Capsule and Gastroduodenal Contractility and Percent of Radiolabeled Meal Retained at 4 Hours on Scintigraphy for Severe Gastroparesis|Agreement between Gastric emptying time of SmartPill capsule (GET>8hrs= severe) and gastroduodenal contractility and percent of radiolabeled meal retained at 4 hours on scintigraphy (>35% = severe)|an expected average of two weeks from study procedure||||percentage of agreement||95% Confidence Interval|Number
2613324|NCT02022826|Primary|Per Patient Device Agreement Between SmartPill Motility Monitoring System Gastric Emptying Time & Gastric Emptying Scintigraphy Test in Patients With Symptoms of Gastroparesis|Per patient device agreement for the diagnosis of delayed gastric emptying between SmartPill Motility Monitoring System (SPM) gastric emptying time (GET >5 hours) and the non-reference standard, gastric Emptying scintigraphy test (>10% retention of a solid meal at 4 hours) in patients with symptoms of gastroparesis|an expected average of two weeks from study procedure||||percentage of agreement||95% Confidence Interval|Number
2613325|NCT02022748|Secondary|Pharmacokinetic Parameter t1/2 of AR-C124910XX||3 days|The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.|||hour||Standard Deviation|Mean
2613326|NCT02022748|Secondary|Pharmacokinetic Parameter t1/2 of Ticagrelor||3 days|The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.|||hour||Standard Deviation|Mean
2613327|NCT02022748|Primary|Pharmacokinetic Parameter AUC0-∞ of AR-C124910XX||0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose|The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2613328|NCT02022748|Primary|Pharmacokinetic Parameter AUC0-∞ (Area Under the Plasma Concentration-time Curve From Time Zero to Infinity) of Ticagrelor||0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose|The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2613329|NCT02022748|Primary|Pharmacokinetic Parameter Cmax of AR-C124910XX||0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose|The PK analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2613330|NCT02022748|Primary|Pharmacokinetic Parameter Cmax of Ticagrelor||0, 1, 2, 4, 6, 12, 24, 36, 48 hours post-dose|The Pharmacokinetic (PK) analysis set included all subjects who received at least 1 dose of study medication and for whom PK data are available with no major protocol deviations thought to significantly affect the pharmacokinetics of ticagrelor or its active metabolite AR-C124910XX.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2613331|NCT02022670|Secondary|Baseline and Week 10 Aortic Pulse Wave Velocity||Baseline (Week 0), Week 10||||cm/sec||Standard Error|Mean
2613332|NCT02022670|Secondary|Baseline and Week 10 Plasma Nitrite Concentrations||Baseline (Week 0), Week 10||||micromolar||Standard Error|Mean
2613333|NCT02022670|Primary|Baseline and Week 10 Flow-Mediated Dilation|Brachial artery flow mediated dilation (FMD) is assessed prior to entering the study. If subjects pass the inclusion requirements, FMD is analyzed at baseline and week 10. Flow-Mediated Dilation is calculated as the percent change in artery diameter in response to 5 minutes of cuff occlusion at Baseline and Week 10 timepoints; i.e. (Peak Diameter-Baseline Diameter)/Baseline Diameter x 100.|Baseline (Week 0), Week 10||||%Change||Standard Error|Mean
2613334|NCT02022657|Primary|Steady State Concentrations of TFV-DP for Different Dosing Patterns of Truvada|TFV-DP concentrations in DBS respective to dosing regimens of 33%, 67%, 100% of daily dosing.|Assessed every 2 weeks during the dosing periods and at steady-state, week 12 for the first dosing period and week 36 for the second dosing period.|The total number of participants was 48. Each participant was randomized to 2 of 3 dosing regimens for a total of 32 participants each, however 2 participants completed only the first regimen.|||fmol/punch||Standard Deviation|Mean
2613335|NCT02022085|Secondary|Numbness When Tested With a Cotton Swab|Degree of numbness when tested with a Cotton Swab|Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24|Safety population; includes all patients who received the surgical intervention.|||Participants|||Count of Participants
2613336|NCT02022085|Secondary|Numbness When Tested With a Pin|Degree of numbness when tested with a pin|Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24|Safety population; includes all patients who received the surgical intervention.|||Participants|||Count of Participants
2613337|NCT02022085|Secondary|Pain & Discomfort|Degree of pain and discomfort.|Week 6, Week 12, Month 6, Month 12, Month 24|Safety population; includes all patients who received the surgical intervention.|||Participants|||Count of Participants
2613338|NCT02022085|Secondary|Sound Processor Magnet Choice|To investigate how sound processor magnet choice will change over time. Six different magnetic strength could be chosen; SPM 1 had the lowest strength and SPM 6 the the highest.|4, 6, 12 weeks, 6, 12 and 24 months|Intention-to-Treat (ITT) population; includes all patients who received surgical intervention at week 4. At week 6, 12 and month 6, 12 and 24 one patient had left the study.|||Participants|||Count of Participants
2613339|NCT02022085|Secondary|Magnetic Force|To investigate if the magnetic force required for sound processor magnet retention will change over time|4, 6, 12 weeks, 6, 12 and 24 months|Intention-to-Treat (ITT) population; includes all patients who received surgical intervention.|||Newton||Standard Deviation|Mean
2613340|NCT02022085|Secondary|Implant Stability|Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability|Visit 2 (surgery)|Intention-to-treat (ITT) population; includes all patients who received surgical intervention.|||units on a scale||Standard Deviation|Mean
2613341|NCT02022085|Secondary|Tissue Reduction Performed During Surgery|Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm|Visit 2 (surgery)|Intention-to-Treat (ITT) population; all patients who received surgical intervention.|||participants|||Number
2613343|NCT02022085|Secondary|Speech, Spatial and Qualities of Hearing Scale (SSQ)|"Measuring change of speech, spatial and hearing experiences with the Baha Attract System from the pre-operative unaided situation. A scale from 0 to 10, where 0 represents can not hear at all, and 10 hear perfectly. The change from unaided to aided hearing is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing."|Baseline before surgery, 6 and 24 months after surgery|Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.|||units on scale||Standard Deviation|Mean
2613344|NCT02022085|Secondary|Abbreviated Profile of Hearing Aid Benefit (APHAB)|Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Baha Attract System from the pre-operative unaided situation. The absolute APHAB scale is between 0 and 100%, where 0% indicates no problems and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment.|Baseline before surgery, 6 and 24 months after surgery|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.|||units on scale||Standard Deviation|Mean
2613345|NCT02022085|Secondary|Health Utility Index (HUI)|"Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Baha Attract System compared to the pre-operative unaided situation. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from unaided to aided hearing is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.~HUI score of 1 (maximum) describes a state of perfect health. HUI score of 0 describes a state of dead. A negative score of Comprehensive Health State describes a state worse than dead."|Baseline (unaided) before surgery, 6 and 24 months after surgery|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.|||units on a scale||Standard Deviation|Mean
2613346|NCT02022085|Secondary|Speech in Quiet: Baha Attract Versus Sound Processor on Softband|"The change of hearing performance with the Baha Attract System at 6 months compared to the pre-operative aided situation with the Sound Processor on a softband; Speech in quiet at 50, 65 and 80dB.~Speech in Quiet is a measure of percentage of correct words. A higher score reflects a higher percentage of correct words."|Baseline (aided) before surgery, 6, 12 and 24 months after surgery|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.|||Change of % correct words at the dB leve||Standard Deviation|Mean
2613347|NCT02022085|Secondary|Adaptive Speech Recognition in Noise Ratio: Baha Attract Versus Sound Processor on Softband|"The change of hearing performance with the Baha Attract System compared to the pre-operative aided situation with Sound Processor on a softband; Adaptive Speech recognition in Noise measured as signal to noise ratio.~A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB."|Baseline (aided) before surgery, 6, 12 and 24 months after surgery|"Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.~Speech in Noise analysis excludes patients from Birmingham and Manchester due to incorrect set up."|||change in SNR dB||Standard Deviation|Mean
2613348|NCT02022085|Secondary|Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband|"The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests:~Threshold audiometry at individual frequencies: 250, 500, 1000, 2000, 3000, 4000, 6000 Hz.~The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds."|Baseline (aided) before surgery, 24 months after surgery|Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.|||dB||Standard Deviation|Mean
2613349|NCT02022085|Secondary|Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband|"The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests:~Threshold audiometry at individual frequencies: 250, 500, 1000, 2000, 3000, 4000, 6000 Hz.~The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds."|Baseline (aided) before surgery, 12 months after surgery|Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.|||dB||Standard Deviation|Mean
2613350|NCT02022085|Secondary|Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband|"The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests:~Threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 Hz.~The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds."|Baseline (aided) before surgery, 6 months after surgery|Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.|||dB||Standard Deviation|Mean
2613351|NCT02022085|Secondary|Hearing Performance: Threshold Audiometry PTA4: Sound Processor on Softband Versus Baha Attract|"The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance, sound processor on a softband, before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz)~The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds."|Baseline before surgery, 6, 12 and 24 months after surgery|Intention-to-Treat (ITT) population; includes all subjects who received the surgical intervention.|||dB||Standard Deviation|Mean
2613352|NCT02022085|Secondary|Speech in Quiet, Baha Attract Versus Unaided|"The change of hearing performance with the Baha Attract System at 6, 12 and 24 months compared to the pre-operative unaided situation; Speech in quiet at 50, 65 and 80dB.~Speech in Quiet is a measure of percentage of correct words. A higher score reflects a higher percentage of correct words."|Baseline before surgery, 6, 12 and 24 months after surgery|Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.|||Change of % correct words at the dB leve||Standard Deviation|Mean
2613353|NCT02022085|Secondary|Adaptive Speech Recognition in Noise Ratio: Unaided Versus Baha Attract|"The change of hearing performance with the Baha Attract System compared to the pre-operative unaided situation; Adaptive speech recognition in noise measured as signal to noise ratio~The adaptive speech test in noise was conducted using validated lists of phonetically balanced sentences, with speech presented from the front (0 degrees azimuth) and noise from the back (180 degrees azimuth). The noise was kept constant at 65 dB SPL, and the speech was adapted in 2 dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding.~A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB.~Manchester and Birmingham are excluded from this analysis due to incorrect set up."|Baseline (unaided) before surgery, 6, 12 and 24 months after surgery|"Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.~Adaptive Speech in Noise analysis excluded subjects from Birmingham and Manchester clinics due to incorrect set up."|||dB||Standard Deviation|Mean
2613354|NCT02022085|Primary|Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract|"The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests:~Threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz.~The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds."|Baseline (unaided) before surgery, 6 months after surgery|Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.|||dB||Standard Deviation|Mean
2613355|NCT02022085|Primary|Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract|"The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry at frequencies of 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz).~The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds."|Baseline (unaided) before surgery, 12 months after surgery|Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.|||dB||Standard Deviation|Mean
2613356|NCT02022085|Primary|Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract|"The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz).~The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds."|Baseline (unaided) before surgery, 24 months after surgery|Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.|||dB||Standard Deviation|Mean
2613357|NCT02022085|Primary|Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract|"The change of hearing performance with the Baha Attract System (aided) at 6, 12 and 24 months from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz).~The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds."|Baseline (unaided) before surgery, 6, 12 and 24 months after surgery|Intention-to-Treat (ITT) population; includes all subjects who received the surgical intervention.|||dB||Standard Deviation|Mean
2613358|NCT02022020|Primary|Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation|Percentages of patients with index events by type (i.e. GI and/or GU) and anatomic location are presented. Multiple bleed locations are possible.|From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days.|Patients who received treatment at two countries (United States and Canada).|||Percentage of participants|||Number
2613359|NCT02022020|Primary|Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge|Percentages of patients receiving general intervention and general intervention combinations (i.e., medications, surgery, therapeutic procedures, transfusion/infusion, discontinuation of dabigatran) to manage the index events until their hospital discharge/release. Multiple interventions are possible.|From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days.|Patients who received treatment at two countries (United States and Canada).|||Percentage of participants|||Number
2613360|NCT02022020|Primary|Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge|"Percentages of patients with index event safety outcomes (ongoing/resolved/deceased) at the time of their hospital discharge/release.~Emergency Department/Room (ED/ER).~Bleeding status at the time of discharge were classified by the principal investigator, using medical record information and medical opinion, as:~Ongoing, if symptoms of bleeding not completely resolved at time of discharge;~Deceased in case of death;~Resolved otherwise."|From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28October2010 (the date of the first data entry)) and 01August2013 (the date of data entry closure); Up to 1008 days.|Patients who received treatment at two countries (United States and Canada).|||Percentage of participants|||Number
2613361|NCT02022007|Other Pre-specified|Number of Participants With No Clinically Significant Changes in Liver Enzyme Levels or Positive Pregnancy Tests|The safety criteria will include laboratory values for liver enzymes and document the absence of pregnancy in all participants during the trial|16 weeks||||Participants|||Count of Participants
2613362|NCT02022007|Secondary|Free Androgen Index (FAI)|Hyperandrogenism is measured by a combination of total testosterone (T) and sex hormone binding globulin (SHBG). The FAI was calculated as the quotient 100 x T/SHBG; hyperandrogenism was defined by a FAI value >3.85.|16 weeks||||index||Standard Deviation|Mean
2613363|NCT02022007|Secondary|Triglyceride (TRG) /HDL-cholesterol Ratio|The measure of TRG levels and HDL- cholesterol levels are used as an estimate of insulin sensitivity. A TRG/HDL-C ratio of greater than 3.0 is used as an indirect measure of insulin resistance|16 weeks||||Ratio||Standard Deviation|Mean
2613364|NCT02022007|Secondary|Menstrual Cycle Interval at 16 Weeks|The number of menstrual cycles during the previous year was recorded and the average menstrual interval calculated by dividing 365 by the number of menstrual cycles in the previous year . During the study period, the patients in a menstrual diary recorded vaginal bleeding over 16 weeks. The effects of treatment intervention on menstrual cycle interval was calculated evaluated by dividing 112 days by the number of menstrual cycles recorded in each patient's menstrual cycle diary.|16 weeks||||days between menstrual cycles||Standard Deviation|Mean
2613365|NCT02022007|Secondary|Waist Circumference at 16 Weeks|The circumference measurement was taken in the upright position using a 15-mm width flexible metric tape held close to the body but not tight enough to indent the skin. Waist circumference (WC) was measured in centimeters at the narrowest level midway between the lowest ribs and the iliac crest.|16 weeks||||centimeters||Standard Deviation|Mean
2613366|NCT02022007|Secondary|Body Mass Index at 16 Weeks|Height and weight measurements were used to calculate body mass index (BMI), defined as kg/m2.|16 weeks||||kg/mg2||Standard Deviation|Mean
2613367|NCT02022007|Secondary|Pancreatic ß-cell Compensatory Function|Post-treatment corrected early phase insulin secretion index (IGI/HOMA-IR). . Early pancreatic β-cell response is estimated as the insulinogenic index (IGI) derived from the ratio of the increment of insulin to that of glucose 30 minutes after a glucose load (insulin 30 min − insulin 0 min/glucose 30 min − glucose 0 min) corrected for by the relative level of insulin resistance (IGI/HOMA-IR which is estimated by homeostasis model assessment of insulin resistance using fasting insulin and glucose levels).|16 weeks||||Ratio||Standard Deviation|Mean
2613368|NCT02022007|Secondary|Matsuda Index of Insulin-Sensitivity (SI OGTT)|Post-treatment insulin sensitivity index. The Matsuda index of whole-body insulin sensitivity is calculated from an oral glucose tolerance test (10,000/square root of [fasting glucose x fasting insulin] x [mean glucose x mean insulin during OGTT]), and is highly correlated with the rate of whole-body glucose disposal during the euglycemic insulin clamp|16 weeks||||Index||Standard Deviation|Mean
2613369|NCT02022007|Secondary|Mean Blood Glucose During the OGTT|Post-treatment mean blood glucose levels. Mean blood glucose (MBG) concentrations were calculated by summing glucose values obtained at 0,30,60 and 120 minutes during the OGTT and dividing by 4.|16 weeks||||mmol/L||Standard Deviation|Mean
2613370|NCT02022007|Secondary|Fasting Glucose|Post-treatment fasting glucose levels|16 weeks||||mmol/L||Standard Deviation|Mean
2613371|NCT02022007|Primary|Oral Disposition Index|Post-treatment in insulin-sensitivity-secretion index . The insulin secretion-sensitivity index (IS-SI) provides an estimate of β-cell compensation relative to the prevailing insulin resistance, not absolute insulin secretion. It is derived by applying the concept of the disposition index (DI) to measurements obtained during the 2-h OGTT. The IS-SI, a surrogate measure of the DI derived from the OGTT (IGI multiplied by the SIOGTT], was calculated as the product of acute β-cell response [IGI] and Matsuda index (SIOGTT) based on the existence of the predicted hyperbolic relationship between these two measures|16 weeks||||index||Standard Deviation|Mean
2613372|NCT02022007|Primary|Glucose Metabolism|Glucose metabolic secretory status after drug treatment (normal, impaired or diabetic). We used the American Diabetes Association (ADA) definition of impairment which is fasting glucose greater than 100 mg/dL and/or 2 hour glucose greater than 140 mg/dL.|16 weeks|Change from impaired to normal was evaluated. No patients were diabetic at the start or completion of the study|||Participants|||Count of Participants
2613373|NCT02021942|Other Pre-specified|Health Related Quality of Life|"Health related quality of life information was collected at Baseline and EOS using SF-36 questionnaire. Questionnaires had to be completed by the patients. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.~Patient reported answers were transformed into domain scores according to the guidelines provided by RAND/MOS. Statistical significance of the result was tested with a paired Wilcoxon rang sum test with a significance level of 0.05 considering only paired values (n=11) using PSPP Version 0.10.1."|at least 6 months|5 out of 16 patients were excluded from analysis due to missing EOS data.|||units on a scale||Standard Deviation|Mean
2613374|NCT02021942|Other Pre-specified|Assessment of Myasthenia Gravis (MG) Status by Measuring ACHR-antibody Concentrations|MG severity status is assessed by measuring ACHR-antibody concentrations at Baseline and EOS.|at least 6 months||||Participants|||Count of Participants
2613375|NCT02021942|Other Pre-specified|Assessment of Myasthenia Gravis (MG) Status by Determining Titin-antibody Status|MG severity status is assessed by determining Titin-antibody status at Baseline and EOS.|at least 6 months||||Participants|||Count of Participants
2613376|NCT02021942|Other Pre-specified|Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)||at least 6 months||||Participants|||Count of Participants
2613377|NCT02021942|Secondary|Assessment of Tumor Operability|Assessment if patients reaching operability at the EOS.|at least 6 months|"Operability of the tumor at the EOS was based on the decision of the treating surgeon. In addition the response criteria had to be fulfilled.~The tumors of 11 patients (68.75%) were operable. One of these patients decided not to undergo surgery. Tumors of 5 patients were inoperable (31.25%) at the EOS."|||Participants|||Count of Participants
2613378|NCT02021942|Secondary|Tumor Resection Status|"To evaluate the resection status based on the categories R0, R1 and ≥ R2 at EOS using CT or MRI imaging.~R0 resection means no residual tumor tissue (best status); R1 indicates microscopic residual tumor tissue and R2 indicates macroscopic residual tumor tissue (worst status)."|at least 6 months||||Participants|||Count of Participants
2613379|NCT02021942|Primary|Percent Change in Tumor Volume From Baseline to EOS|To evaluate whether SOM230 LAR is effective in patients with inoperable thymoma with respect to shrinkage of tumor volume. Response is defined as the decrease in tumor volume of 20 % at EOS as compared to baseline. Tumor shrinkage is assessed by CT or MRI.|at least 6 months|Initial diagnosis of thymoma for one patient could not be confirmed, but a squamous cell carcinoma was diagnosed by the central pathologist. Tumor voume was 320.99 cm^3 at screening. Tumor size was reduced to 176.87 cm^3 at month 2 (-44.9 % compared to baseline). At month 4 (EOS) tumor volume was slightly increased compared to month 2 (189 cm^3).|||percentage of tumor volume||95% Confidence Interval|Mean
2613400|NCT02021643|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set|||Participants|||Count of Participants
2613380|NCT02021929|Secondary|Change From Baseline in Percentage of Progenitor Cells (Peripheral Blood Mononuclear Cells or PBMCs)|"Progenitor Cells (Peripheral Blood Mononuclear Cells or PBMCs) are obtained and measured from blood samples collected from each participant.~Difference in change from baseline to 12 weeks in the Percentage of Progenitor Cells between sorafenib and placebo groups."|Baseline to 12 weeks|Since all of the participants did not complete the 12 week study visit, data from fewer participants were available to be analyzed in each arm for this measure.|||percentage of PBMCs||Inter-Quartile Range|Median
2613381|NCT02021929|Secondary|Number of Participants With Improvement in Intrapulmonary Shunting From Baseline to 12 Weeks.|"Intrapulmonary shunting is measured based on results from a saline-bubble echo test.~Number of participants with measured improvement in intrapulmonary shunting from baseline to 12 weeks in the sorafenib and placebo groups"|Baseline to 12 weeks|Since all of the participants did not complete the 12 week study visit, data from fewer participants were available to be analyzed in each arm for this measure.|||Participants|||Count of Participants
2613382|NCT02021929|Primary|Change in Alveolar-arterial Oxygen Gradient Between Sorafenib and Placebo Groups|"Alveolar-arterial oxygen gradient is a calculated measure of oxygenation. It is the difference between the amount of the oxygen in the alveoli and the amount of oxygen in arterial blood.~Calculation is based on values from an Arterial Blood Gas test. Difference in change in alveolar-arterial oxygen gradient between sorafenib and placebo from baseline to 12 weeks."|Baseline to 12 weeks||||mm Hg||Inter-Quartile Range|Median
2613383|NCT02021812|Secondary|Number of Participants With 1 Month Device Related Endoleaks Assessed by an Independent Core Lab|Device-related endoelaks are defined as the presence of contrast within the aneurysm sac originating from the junction between any Branched TAG® Device component and the adjacent tissue (endoleak type IA or IB) OR the junction between the Aortic Component and either the SB Component or the Aortic Extender (type III endoleak).|1 month post procedure|1 participant was not assessed at 1 Month|||Participants|||Count of Participants
2613384|NCT02021812|Secondary|Number of Participants With 1 Month Side Branch Primary Patency Assessed by an Independent Core Lab||1 month post procedure||||Participants|||Count of Participants
2613385|NCT02021812|Primary|Number of Participants With Primary Procedural Side Branch Patency as Assessed by Angiography|The presence of forward flow through the implanted Side Branch Component into the target branch vessel.|At conclusion of the treatment procedure (day 0)||||Participants|||Count of Participants
2613386|NCT02021812|Primary|Number of Participants With Successful Study Device Deployment|Absence of deployment failure will be considered a successful deployment. Deployment failure will be considered the failure of any Branched TAG® Device component (Aortic Component, Aortic Extender, or SB Component) to be released from the delivery catheter resulting in a serious adverse event (SAE) due to mechanical failure or use error.|During treatment procedure (day 0)||||Participants|||Count of Participants
2613387|NCT02021812|Primary|Number of Participants With Successful Study Device Access|Access to the aneurysm and target landing zone location is obtained via conventional vascular access and endovascular techniques.|During treatment procedure (day 0)||||Participants|||Count of Participants
2613388|NCT02021669|Secondary|Hamilton Depression Rating Scale (HAM-D, 17)|The HAM-D, 17 is a 17-item, observer-rated measure of depression symptoms. The minimum and maximum values for the HAM-D, (0-52). For both instruments, the higher the scores, the greater the severity of depression.|Change from baseline to 10 weeks (post-treatment)||||score on a scale||Standard Deviation|Mean
2613389|NCT02021669|Primary|Beck Depression Inventory-II (BDI-II)|The BDI-II is a 21-item self-report inventory of depression symptoms. The minimum and maximum values for the BDI-II are (0-63). For both instruments, the higher the scores, the greater the severity of depression.|Change from baseline to 10 weeks (post-treatment)||||score on a scale||Standard Deviation|Mean
2613390|NCT02021656|Secondary|HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only||Baseline; Week 12|Only Chinese participants in the Full Analysis set were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2613391|NCT02021656|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR.|Week 12 to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2613392|NCT02021656|Secondary|Percentage of Participants Experiencing Viral Breakthrough|Viral breakthrough were defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve a sustained virologic response (SVR).|Up to 12 weeks|Full Analysis Set|||percentage of participants|||Number
2613393|NCT02021656|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2613394|NCT02021656|Primary|Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2613395|NCT02021656|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL in Korea and Taiwan and < 15 IU/mL in China) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full analysis set: participants who were enrolled and received at least 1 dose of study drug, and have chronic genotype 1 HCV infection.|||Percentage of participants||95% Confidence Interval|Number
2613396|NCT02021643|Secondary|Change From Baseline in HCV RNA (log10 IU/mL)||Up to 24 weeks|Participants in the Full Analysis Set with available data were analyzed|||log10 IU/mL||Standard Deviation|Mean
2613397|NCT02021643|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.|Up to Posttreatment Week 24|Full Analysis Set|||Participants|||Count of Participants
2613398|NCT02021643|Secondary|Percentage of Participants With On-Treatment Virologic Failure|Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment.|Up to 24 weeks|Full Analysis Set|||Participants|||Count of Participants
2613401|NCT02021643|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants who enrolled in the study and received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2613402|NCT02021565|Secondary|Caregiver Burden|Zarit Burden Interview Revised -indicating caregiver burden. Caregivers endorse 22 items using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Higher scores reflect greater caregiver burden. Scores range from 0 to 88.|T1 Baseline and T2 Post Intervention; 4-6 Weeks|Composite caregiver burden reported by informal caregiver. Ten caregivers from the Intervention group and seven caregivers from the Control group did not complete T2 and their data was not analyzed.|||units on Zarit Burden scale||Standard Deviation|Mean
2613403|NCT02021565|Secondary|Veteran Task Efficacy|Veteran care recipient reported confidence in the performance of 10 activity of daily living tasks rated on scale of 1-10. Items are assessed for efficacy with and without (independently) assistance provided from a caregiver. Scores range from 10-100 with higher scores reflecting greater task efficacy.|T1 baseline and T2 Post Intervention; 4-6 weeks|Veteran care recipient reported efficacy in performing transfer tasks with assistance from informal caregiver and independently. One Veteran from the Intervention group did not complete T2 and their data were not analyzed.|||units on a scale||Standard Deviation|Mean
2613404|NCT02021565|Primary|Caregiver Transfer Efficacy|Caregiver reported the level of confidence that Veteran care recipient can perform 10 activity of daily living tasks rated on scale of 1-10. Efficacy in task completion reported both with assistance from the informal caregiver and performed independently by the Veteran. Scores range from 10-100 with higher scores reflecting greater transfer efficacy.|T1 Baseline and T2 Post Intervention; 4-6 Weeks|Caregivers who reported their Veteran care recipient performed transfer tasks with assistance from informal caregiver. Two caregivers from the Intervention group and four caregivers from the Control group did not complete T2 and their data was not analyzed.|||units on a scale||Standard Deviation|Mean
2613405|NCT02021461|Primary|Assessment of Taste Preference|Subject preference for 3 flavours of the ESL oral suspension was assessed based on a measured score using a 0-10 cm (minimum and maximum measured values) Visual Analogue Scale (VAS). Higher values represent the stronger preference.|single Study Day||||units on a scale (0-10 cm VAS)||Standard Deviation|Mean
2613406|NCT02021331|Other Pre-specified|Bony Dimensional Changes|Measurements will be based off of standardized x-rays and CBCT.|Baseline, 6mo & 12mo after baseline|Data was not collected||||||
2613407|NCT02021331|Secondary|Implant Survival|Checking to make sure the implant is stable.|2wk, 4wk, 6wk, 3mo, 6mo, 12mo||||Participants|||Count of Participants
2613408|NCT02021331|Primary|Soft Tissue Diemensional Change|Tissue thickness will be measured from the digital impression and CBCT data from the hard tissue.|Baseline, 12mo after baseline|Data was not collected.||||||
2613409|NCT02021292|Post-Hoc|Post-hoc Analysis of Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest Excluding Subjects With Incorrect Hemodynamic Values.|The main analysis of the primary efficacy endpoint of PVR has been repeated excluding 4 subjects (3 macitentan, 1 placebo) with incorrect PVR values. The corrected hemodynamic values were reported after the clinical database closure (see post-hoc analysis 1 above). The primary efficacy endpoint is defined as the PVR at rest at Week 16 expressed as percent of baseline PVR at rest.|From baseline to Week 16|Modified full analysis set|||Percent of baseline PVR||95% Confidence Interval|Geometric Mean
2613410|NCT02021292|Post-Hoc|Post-hoc Analysis of Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest Including Subjects With Corrected Hemodynamic Values.|The main analysis of the primary efficacy endpoint of PVR has been repeated using the corrected hemodynamic values reported after the clinical database closure for 4 subjects (3 macitentan, 1 placebo). The primary efficacy endpoint is defined as the PVR at rest at Week 16 expressed as percent of baseline PVR at rest.|From baseline to Week 16|Full analysis set|||Percent of baseline PVR||95% Confidence Interval|Geometric Mean
2613411|NCT02021292|Secondary|Proportion of Subjects With Worsening in WHO Functional Class (FC) From Baseline to Week 24|"WHO functional classes are defined as follows: 1) class I: no symptoms with exercise or at rest. No limitation of activity. 2) class II: No symptoms at rest but slight limitation with ordinary activities causing symptoms (e.g. short of breath with climbing a flight of stairs, grocery shopping, or making the bed). 3) class III: may not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting. 4) class IV: symptoms at rest (such as dyspnea and/or fatigue) and inability to carry out any physical activity without symptoms (e.g. may faint especially while bending over with their heads lowered). Patients in class IV manifest signs of right heart failure.~Shifting to a higher class (e.g. from class III to class IV) represents a 'worsening' while shifting to a lower class (e.g. from class III to class II) means an 'improvement'."|From baseline to Week 24|Full analysis set|||Participants|||Count of Participants
2613412|NCT02021292|Secondary|Change From Baseline to Week 24 in Borg Dyspnea Index Collected at the End of the 6-minute Walk Test (6MWT).|This outcome measures the difference in the Borg dyspnea index collected at the end of the 6-minute walk test (6MWT) at Week 24 compared to baseline. The Borg dyspnea index rates the severity of dyspnea (difficult or labored breathing) on a scale from 0 ('Nothing at all') to 10 ('Very, very severe - maximal'). A decrease in the Borg dyspnea index indicates an improvement.|From baseline to Week 24|Full analysis set|||Score on a scale||Standard Deviation|Mean
2613413|NCT02021292|Secondary|Change From Baseline to Week 24 in Exercise Capacity, as Measured by the 6-minute Walk Distance (6MWD).|The purpose of the six minute walk is to test exercise tolerance and capacity. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.|From baseline to Week 24|Full analysis set|||meter||Standard Deviation|Mean
2613414|NCT02021292|Primary|Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest.|The primary efficacy endpoint is defined as the PVR at rest at Week 16 expressed as percent of baseline PVR at rest.|From baseline to Week 16|Full analysis set|||percent of baseline PVR||95% Confidence Interval|Geometric Mean
2613485|NCT02020304|Secondary|Analgesia Onset-10 Minutes Post Injection||up to 3 hours|number of subjects who achieved a VAS pain score of </= 3 at 10 minutes after CSE injection|||Participants|||Count of Participants
2613415|NCT02021071|Secondary|Fluoroscopy Time|Measure fluoroscopy time (minutes) needed during needle interventional procedure and compare the collected results with existing data from needle interventional procedures performed using XperGuide alone.|Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest||||Minutes||Full Range|Median
2613416|NCT02021071|Primary|System Usability Scale (SUS) Score as a Measure of Qualitative Clinical Usefulness|"Evaluate the workflow, usability, and clinical impact of device by assessing clinical outcome and success of the procedures.~The SUS is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability developed by Brooke, J. The user needs to provide agreement or disagreement for the 10 statements. After the appearing of the SUS in literature and once part of the ISO standard ISO 9241 Part 11 it has become an industry standard and has been used for over 25 years to measure usability.~The minimum score is 0 and the maximum core is 100. Analysis of 500 studies with SUS showed that the average SUS score is a 68. A SUS score above a 68 would be considered above average and anything below 68 is below average"|Patients will be followed starting from the procedure until hospital discharge or until 2 weeks after date of procedure at the latest|SUS Score is only assessed for new technology (arm/group: XperGuide with virtual path planning)|||Scores on a scale||Standard Deviation|Mean
2613417|NCT02020941|Secondary|Treatment Related Adverse Events Grade 3 or Higher|Number of unique patients who had a treatment related (possible, probable or definite) adverse events that were graded 3 or greater.|Up to 30 days after completion of study treatment, up to 2 years|All patients enrolled and received treatment.|||participants|||Number
2613418|NCT02020941|Secondary|Duration of Response (DOR)|Analysis will be performed using Kaplan-Meier estimates. Time from date of first confirmed response of partial response or better to date of progression or death. Only patients who had a response of partial response or better will be included in this analysis.|Time from first evidence of PR or better to disease progression or death, assessed up to 2 years|All patients who had a response of partial response or better|||months||95% Confidence Interval|Median
2613419|NCT02020941|Secondary|Time to Progression (TTP)|Analysis will be performed using Kaplan-Meier estimates. Time from date on treatment to date of progression. The observations of patients who died or remained alive and progression free were censored at date of death or last disease evaluation, respectively.|Time from first dose to disease progression, assessed up to 2 years|All patients enrolled and received treatment.|||months||95% Confidence Interval|Median
2613420|NCT02020941|Secondary|Progression-free Survival (PFS)|Analysis will be performed using Kaplan-Meier estimates. Time from date on treatment to date of progression for patients who progressed or date of death for patients who died without progressing. The observations of patients remaining alive and progression free were censored at date of last disease evaluation.|Time from first dose to first observed disease progression or death, assessed up to 2 years|All patients enrolled and received treatment.|||months||95% Confidence Interval|Median
2613421|NCT02020941|Secondary|Overall Response Rate (ORR) After 4 Courses of Treatment|Evaluate the overall response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. Responses will be defined using the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC).|At 16 weeks|All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit|||percentage of participants||95% Confidence Interval|Number
2613422|NCT02020941|Primary|Overall Response Rate (ORR) After 8 Courses of Treatment|: Evaluate the overall response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. Responses will be defined using the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC).|At 32 weeks|All patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit|||percentage of participants||95% Confidence Interval|Number
2613423|NCT02020889|Secondary|Maximum Change From Baseline in QTcF and QTcB Values|Single measurements of 12-lead ECGs were obtained after 5 minutes rest in a supine position at Baseline throughout the 52 weeks treatment period and 8 weeks follow-up period using an ECG machine. Maximum change from Baseline in QTcF and QTcB values were measured.|Baseline and up to Week 60|Safety Population|||msec||Standard Deviation|Mean
2613424|NCT02020889|Secondary|Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values|Single measurements of 12-lead electrocardiogram (ECGs) were obtained after 5 minutes rest in a supine position at Baseline throughout the 52 weeks treatment period and 8 weeks follow-up period using an ECG machine. Mean change from Baseline in QTcF and QTcB values were measured. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Week 60|Safety Population|||milliseconds (msec)||Standard Deviation|Mean
2613425|NCT02020889|Secondary|Change From Baseline in Body Temperature|Body temperature was measured from Baseline throughout follow-up (till Week 60). The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. The analysis was performed on Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||Degree celsius||Standard Deviation|Mean
2613426|NCT02020889|Secondary|Change From Baseline in Pulse Rate|Pulse rate was measured from Baseline throughout follow-up (till Week 60) before injection with the participant sitting, having rested in this position for at least 5 minutes before reading. The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||beats per minute (bpm)||Standard Deviation|Mean
2613486|NCT02020304|Secondary|Analgesia Onset-5 Minutes Post Injection||from time of CSE administration|number of subjects who achieved a VAS pain score of </=3 at 5 minutes after CSE injection|||Participants|||Count of Participants
2614835|NCT02006758|Secondary|Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months||Baseline and 12 months|38 out of 67 analyzed for renal function change based on eGFR at 12 months.|||mL/min per 1.73 m^2||Standard Deviation|Mean
2613427|NCT02020889|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels|SBP and DBP were measured from Baseline throughout follow-up (till Week 60) before injection with the participant sitting, having rested in this position for at least 5 minutes before reading. The Baseline value was taken at Visit 2 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline up to Week 60|Safety Population|||millimeter of mercury (mm of Hg)||Standard Deviation|Mean
2613428|NCT02020889|Secondary|Number of Participants With Anti-Mepolizumab Antibodies|Blood samples were collected for the determination of anti-Mepolizumab antibodies. Participants who showed presence of anti-Mepolizumab antibody were termed as 'positive' and those who did not have anti-Mepolizumab antibody in blood sample were termed as 'negative'. Participants who did not have a positive ADA assay prior to the first dose of investigational product were included in the analysis.|Up to Week 60|Safety Population|||Participants|||Number
2613429|NCT02020889|Secondary|Change From Baseline in Hematology Parameters of Erythrocytes Levels|Blood samples were collected to evaluate change from Baseline in erythrocytes values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||10^12 cells/L||Standard Deviation|Mean
2613430|NCT02020889|Secondary|Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels|Blood samples were collected to evaluate change from Baseline in MCH values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||Picogram (pg)||Standard Deviation|Mean
2613431|NCT02020889|Secondary|Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels|Blood samples were collected to evaluate change from Baseline in MCV values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||femtoliter (fL)||Standard Deviation|Mean
2613432|NCT02020889|Secondary|Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels|Blood samples were collected to evaluate change from Baseline in MCHC and hemoglobin values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||g/L||Standard Deviation|Mean
2613433|NCT02020889|Secondary|Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels|Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelet values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||10^9 cells/L||Standard Deviation|Mean
2613434|NCT02020889|Secondary|Change From Baseline in Clinical Chemistry Parameter of Troponin Levels|Blood samples were collected to evaluate change from Baseline in troponin values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||µg/L||Standard Deviation|Mean
2613435|NCT02020889|Secondary|Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Phosphorus, Potassium, Sodium, Urea Nitrogen and Very Low Density Lipoprotein (VLDL) Cholesterol Levels|Blood samples were collected to evaluate change from Baseline in calcium, chloride, cholesterol, glucose, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, phosphorus, potassium, sodium, urea nitrogen and very low density lipoprotein (VLDL) cholesterol values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured. NA indicates that data were not available.|Baseline and up to Week 60|Safety Population|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2613436|NCT02020889|Secondary|Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels|Blood samples were collected to evaluate change from Baseline in direct, indirect and total bilirubin and creatinine values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||micromole per liter (µmol/L)||Standard Deviation|Mean
2613487|NCT02020304|Primary|Time|length of time in minutes the combined spinal epidural dose duration is calculated from the time of administration until the request is made for additional analgesia (~1.5-3 hours) post dose. The subjects epidural is then dosed as per standard of care.|up to 3 hours||||minutes||Standard Deviation|Mean
2613437|NCT02020889|Secondary|Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels|Blood samples were collected to evaluate change from Baseline in albumin and protein levels values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety Population|||gram per liter (g/L)||Standard Deviation|Mean
2613438|NCT02020889|Secondary|Change From Baseline in Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk.Phosph.), Aspartate Aminotransferase (AST), Creatinine Kinase, Gamma Glutamyl Transaminase (GGT) and Lactate Dehydrogenase (Dehydro) Levels|Blood samples were collected to evaluate change from Baseline in ALT, Alk.phosph., AST, creatinine kinase, GGT and lactate dehydro values at Baseline throughout the 52 weeks study treatment and 8-weeks follow up period. Baseline values were taken at Visit 2 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were measured.|Baseline and up to Week 60|Safety population|||International Unit per Liter (IU/L)||Standard Deviation|Mean
2613439|NCT02020889|Secondary|Number of Participants With Local and Systemic Adverse Events (AEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs including systemic allergic and non-allergic reactions as well as local site injection-related reactions were counted throughout treatment phase and follow up phase. Systemic allergic reactions included Facial paralysis, flushing, hypersensitivity and rash pruritic. Injection related reactions were considered as systemic non-allergic reactions. Local site reactions included injection site bruising, erythema, pain and reaction. The analysis was performed on Safety Population which comprised of all participants who receive at least one dose of study treatment.|Up to Week 52|Safety Population|||Participants|||Number
2613440|NCT02020889|Secondary|Number of Participants Who Achieved Remission (BVAS=0 and Prednisolone/Prednisone <=7.5 mg/Day) Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period|The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone <=7.5mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.|Up to Week 52|ITT Population|||Participants|||Number
2613441|NCT02020889|Secondary|Number of Participants Who Are in Remission at 36 and 48 Weeks|The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone <=7.5mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.|Week 36 and Week 48|ITT Population|||Participants|||Number
2613442|NCT02020889|Secondary|Number of Participants in Each Category of Accrued Duration of Remission|Total accrued duration of remission, i.e., the accrued number of weeks where Birmingham Vasculitis Activity Score (BVAS) =0 plus prednisolone/prednisone dose <=7.5mg/day over the 52 week study treatment period was reported. BVAS is a validated, clinician-completed tool used for the comprehensive multisystem clinical assessment of disease activity in systemic vasculitis. The duration was categorized into zero, >0 to <12 weeks, 12 to <24 weeks, 24 to <36 weeks and >=36 weeks. Statistical analysis was performed on ITT Population and was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.|Up to Week 52|ITT Population|||Participants|||Count of Participants
2613443|NCT02020889|Secondary|Number of Participants Who Achieved Remission Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period|The number of participants who achieved remission (i.e., BVAS=0 and prednisolone/prednisone<=4 mg/day) within the first 24 weeks and remain in remission for the remainder of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.|Up to Week 52|ITT Population|||Participants|||Number
2613444|NCT02020889|Secondary|Number of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period.|The number of participants with an average daily prednisolone/prednisone dose during the last 4 weeks of the Study Treatment Period (48 through 52) was calculated. The average dose was categorized into zero, >0 to <=4.0mg, >4.0 to <=7.5mg and >7.5mg. The statistical analysis was performed using a proportional odds regression model with Baseline covariates of treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region and the comparison between treatment groups was presented as an odds ratio, p-value and 95 percent CI.|Week 48 and Week52|ITT Population|||Participants|||Count of Participants
2613445|NCT02020889|Secondary|Time to First EGPA Relapse|EGPA relapse was defined as worsening or persistence of active disease since the last visit characterized by active vasculitis or active asthma symptoms and/or signs with a corresponding worsening in Asthma Control Questionnaire-6 (ACQ-6) score or active nasal and/or sinus disease, with a corresponding worsening in at least one of the sino-nasal symptom questions warranting: i) an increased dose of OCS therapy (or other systemic corticosteroid therapy) to >4 mg/day prednisolone total daily dose or equivalent; OR ii) an increased dose or addition of immunosuppressive therapy; OR iii) hospitalization related to EGPA worsening. Participants who completed study, or withdrawn prematurely from the study without experiencing the event were censored. The number of participants with at least one EGPA relapse during the planned study treatment period are presented.|Up to Week 52|ITT Population|||Participants|||Number
2613446|NCT02020889|Primary|Number of Participants Who Are in Remission at 36 and 48 Weeks|The number of participants who were in remission (i.e ., BVAS=0 and prednisolone /prednisone <=4 mg/day) at both Weeks 36 and 48 of the study treatment period was reported. The statistical analysis was performed using a logistic regression model on ITT Population. The odds ratio for treatment difference and associated p-value and 95 percent CI were calculated.|Week 36 and Week 48|ITT Population|||Participants|||Number
2613447|NCT02020889|Primary|Number of Participants in Each Category of Accrued Duration of Remission|Total accrued duration of remission is the accrued number of weeks where Birmingham Vasculitis Activity Score (BVAS) =0 plus prednisolone/prednisone dose <=4 mg/day over the 52 week study treatment period was reported. The accrued duration was categorized into zero, >0 to <12 weeks, 12 to <24 weeks, 24 to <36 weeks and >=36 weeks. Statistical analysis was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Baseline BVAS score and region. Intent-to-Treat (ITT) Population was used for the analysis and was defined as all participants who were randomized and received at least one dose of trial medication. Randomized participants were assumed to have received study treatment unless definitive evidence to the contrary exists. The odds ratio for treatment difference and associated probability (p)-value and 95 percent confidence interval (CI) were calculated.|Up to Week 52|ITT Population|||Participants|||Count of Participants
2613448|NCT02020863|Primary|Fluid Status During Surgery|The primary outcome between groups is preload independence, defined as % case time where Stroke Volume Variation (SVV) is ≤12%.|Duration of Surgery, up to 8 hours|Closed Loop Study population at Stroke Volume Variation (SVV) ≤12%|||percentage of case time||Standard Deviation|Mean
2613449|NCT02020837|Primary|Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery|Lymphatic Volumetric Assessment. Evaluation of the volumetric change, relative to baseline measurement, in the volume of the affected limb at 3 and 6 months from the procedure.|3 and 6 months from surgery|Early termination leading to small numbers of subjects.Outcome measures not computed because data would not be statistically relevant.||||||
2613450|NCT02020785|Secondary|Diastolic Blood Pressure|Blood pressure measured at the end of weeks 1, 2, and 3. At each visit, 3 readings were obtained in the seated position by trained and certified observers after 5 minutes of rest with an Omron HEM-907 device (Omron Healthcare Inc, Bannockburn, Ill) using a standardized protocol. We used the average of all these readings taken during end of weeks 1, 2, and 3 for each period.|2-3 weeks||||mmHg||Standard Deviation|Mean
2613451|NCT02020785|Secondary|Systolic Blood Pressure|Blood pressure was measured at the end of weeks 1, 2, and 3. At each visit, 3 readings were obtained in the seated position by trained and certified observers after 5 minutes of rest with an Omron HEM-907 device (Omron Healthcare Inc, Bannockburn, Ill) using a standardized protocol. We used the average of all blood pressure measurements at the end of weeks 1, 2, and 3 for each period.|2-3 weeks||||mmHg||Standard Deviation|Mean
2613452|NCT02020785|Primary|Fibroblast Growth Factor-23 (FGF-23)|"Plasma FGF-23 will be measured at the end of each 3 week period in the morning after an overnight fast.~As this is a small pilot study, we will not adjust for multiple comparisons. A p value<0.05 will be considered statistically significant for both outcomes"|3 weeks||||Relative units/ml||95% Confidence Interval|Geometric Mean
2613453|NCT02020785|Primary|24-hour Urine Albumin Excretion|Two 24-hour urine collections will be collected during the 3rd week of each period|3 weeks||||mg/day||95% Confidence Interval|Mean
2613454|NCT02020616|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC [τ,ss]) of LY3053102|AUC (τ,ss) = area under the concentration versus time curve during one dosing interval at steady state, where the dosing interval (τ) = 168 hours.|Predose, 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 hours post-dose|All randomized participants who received at least 1 dose of study drug and had evaluable pharmacokinetics|||microgram•hour/milliliter (µg•h/mL)||Geometric Coefficient of Variation|Geometric Mean
2613455|NCT02020616|Secondary|Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint|LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug.|||milligram/square centimeter (mg/cm2)||Standard Error|Least Squares Mean
2613456|NCT02020616|Secondary|Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP])|LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug.|||nanogram/milliliter (ng/mL)||Standard Error|Least Squares Mean
2613457|NCT02020616|Secondary|Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP])|LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug.|||microgram/liter (ug/L)||Standard Error|Least Squares Mean
2613458|NCT02020616|Secondary|Percentage of Participants With Hypoglycemia|Hypoglycemia was defined as any event meeting the criteria for documented symptomatic hypoglycemia, asymptomatic hypoglycemia, or probable symptomatic hypoglycemia.|Baseline through Week 12|All randomized participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2613459|NCT02020616|Secondary|Percentage of Participants With Anti-Drug Antibodies to LY3053102|Percentage of participants with anti-LY3053102 antibody titre changes from baseline to the maximum postbaseline value.|Baseline through Study Completion (Up to 6 Months)|All randomized participants who received at least 1 dose of study drug and had evaluable immunogenicity.|||Percentage of Participants|||Number
2613460|NCT02020616|Secondary|Change From Baseline in Lipids at 12-Week Endpoint|Lipids includes: High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Triglycerides, and Cholesterol. LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.|||mg/dL||Standard Error|Least Squares Mean
2613510|NCT02019979|Secondary|Number of Participants With LKBI Mutation|To evaluate LKBI mutations as a potential bio-marker to predict subjects who will benefit most from metformin in combination with a carbohydrate restricted diet|6 months||||Participants|||Count of Participants
2613461|NCT02020616|Secondary|Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint|7-Point Self-Monitored Blood Glucose profiles are measures of blood glucose concentration taken 7 times a day at morning pre-prandial, morning 2 hours postprandial, midday pre-prandial, midday 2 hours postprandial, evening pre-prandial, evening 2 hour postprandial, and bedtime. LS means were calculated using MMRM analysis adjusting for baseline HbA1c category, metformin use, washout of second OAM, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.|||milligram/deciliter (mg/dL)||Standard Error|Least Squares Mean
2613462|NCT02020616|Secondary|Change From Baseline in Body Weight at 12-Week Endpoint|LS means were calculated using MMRM analysis adjusting for baseline HbA1c category, metformin use, washout of second OAM, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.|||kilogram (kg)||Standard Error|Least Squares Mean
2613463|NCT02020616|Secondary|Percentage of Participants That Require Rescue Therapy|Percentage of participants that required >=1 rescue (blood glucose lowering) medications.|Baseline through Week 12|All randomized participants who took at least 1 dose of study drug, and who had a baseline and a post-baseline measurement for the time point.|||Percentage of Participants|||Number
2613464|NCT02020616|Secondary|Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.|Week 12|All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.|||Percentage of Participants|||Number
2613465|NCT02020616|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) analysis adjusting for metformin use, washout of second oral anti-hyperglycemic medication (OAM), treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect.|Baseline, Week 12|All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.|||Percent of HbA1c||Standard Error|Least Squares Mean
2613466|NCT02020577|Secondary|Recommended Phase II Dose Based on the Number of Patients With Dose Limiting Toxicity Events (Afatinib)|MTD was deemed the recommended Phase II dose based on the number of patients with dose limiting toxicity events at all treatment cycles.|All treatment cycle (each treatment cycle of 21 days)|Treated Set|||mg|||Number
2613467|NCT02020577|Secondary|Disease Control Rate|"For patients with measurable disease, disease control was defined as the proportion of patients having at least a best overall response of CR, PR or stable disease (SD).~As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:~Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression"|Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 19 months|Treated set|||Percentage of participants|||Number
2613468|NCT02020577|Secondary|Objective Response|"Objective response was defined as the proportion of patients with measurable disease having at least a best overall response of complete response (CR) or partial response (PR), according to RECIST version 1.1.~As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:~Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression."|Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 19 months|Treated set|||Percentage of participants|||Number
2613469|NCT02020577|Secondary|Best Overall Response|"Best overall response (according to RECIST version 1.1) was defined as the best response recorded at any time from the first administration of afatinib or cetuximab to the End of Treatment (EOT).~As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:~Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression."|Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 19 months|Treated set|||Percentage of participants|||Number
2613470|NCT02020577|Secondary|Recommended Phase II Dose Based on the Number of Patients With Dose Limiting Toxicity Events (Cetuximab)|MTD was deemed the recommended Phase II dose based on the number of patients with dose limiting toxicity events at all treatment cycles.|All treatment cycle (each treatment cycle of 21 days)|Treated Set|||mg/m2|||Number
2613471|NCT02020577|Secondary|Dose Limiting Toxicities During All Treatment Cycles|Number of patients with DLT occuring during all treatment cycle is presented|All treatment cycle (each treatment cycle of 21 days)|Treated Set|||Participants|||Number
2613472|NCT02020577|Primary|MTD of Afatinib in Combination With Cetuximab Based on the Number of Patients With DLTs During the First Treatment Cycle (Cetuximab).|Maximum Tolerated Dose (MTD) of Afatinib in combination with cetuximab based on the number of patients with DLTs during the first treatment cycle (Dose escalation part).|First treatment cycle|Dose finding cohort treated set|||mg/m2|||Number
2613511|NCT02019979|Secondary|Overall Survival|Overall survival (OS) is defined as time from date of first dose to date of death from any cause.|up to 30 months||||months||Full Range|Mean
2613473|NCT02020577|Primary|Dose Limiting Toxicities During Cycle 1|"Number of Patients With Dose Limiting Toxicity (DLT) Occurring during Cycle 1. The following drug related AEs qualified as DLT:~1) CTCAE Grade ≥2 decrease in cardiac left ventricular function 2) CTCAE Grade 2 diarrhoea lasting for ≥7 days, despite appropriate use of standard antidiarrheal therapy based on Protocol Amendment 1 dated 22 Oct 2013 3) CTCAE Grade ≥3 diarrhoea despite appropriate use of standard anti-diarrheal therapy for at least 2 days. 4) CTCAE Grade ≥3 nausea and/or vomiting despite appropriate use of standard anti-emetics for at least 3 days 5) CTCAE Grade ≥3 rash despite standard medical management. 6) CTCAE Grade ≥3 fatigue lasting more than 7 days. 7) All other AEs of CTCAE Grade ≥3 (except alopecia and allergic reaction) that led to an interruption of afatinib and/or cetuximab dosing for more than 14 days until recovery to baseline or Grade 1, whichever was higher. 8) CTCAE Grade 4 hypomagnesemia or Grade 3 hypomagnesemia with clinically-significant sequelae"|First 21-day treatment cycle|Dose finding cohort treated set.|||Participants|||Number
2613474|NCT02020577|Primary|MTD of Afatinib in Combination With Cetuximab Based on the Number of Patients With DLTs During the First Treatment Cycle (Afatinib).|Maximum Tolerated Dose (MTD) of Afatinib in combination with cetuximab based on the number of patients with dose limiting toxicity (DLT) during the first treatment cycle (Dose escalation part). The MTD is defined as the highest dose level at which less than 33% of the patients experience DLT in first treatment cycle.|First 21 days treatment cycle|Dose finding cohort treated set: This patient set includes all patients enrolled in part A of the trial who were documented to have taken at least one dose of study medication.|||mg|||Number
2613475|NCT02020512|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Week 5|Intent-to-Treat: all treated patients|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2613476|NCT02020408|Secondary|Dopamine D2/D3 Receptor Binding as Measured During the PET Scan After Amphetamine Administration|Use PET and [11C]raclopride to explore Dopamine D2/D3 receptor binding potential (BPND) in striatal regions of interest in eating disorder subtypes after amphetamine administration. The Binding Potential (BP) was calculated as BP Non Displaceable (ND) = (VT/VND) −1. [VT = distribution volume in tissue; VND = non-displaceable distribution volume].|90 min PET scan|Due to technical problems and temporary closure of the PET Facility during the study and consequent lack of time and funding for additional scanning, we were unable to recruit a sufficient number of women recovered from bulimia nervosa (BN) for the AMPHETAMINE CHALLENGE STUDY and therefore no data for this outcome measure were collected in REC BN.|||binding potential (BPND)||Standard Deviation|Mean
2613477|NCT02020408|Primary|5-HT Transporter Binding as Measured During the PET Scan|"Use PET and [11C]DASB to explore 5-HTT receptor binding potential midbrain and striatal regions of interest in eating disorder subtypes.~The Binding Potential (BP) was calculated as BP Non Displaceable (ND) = (VT/VND) −1. [VT = distribution volume in tissue; VND = non-displaceable distribution volume]. The binding of the 5-HTT on PET presumably reflects 5-HTT density and/or affinity."|90 minute PET scan||||binding potential (BPND)||Standard Deviation|Mean
2613478|NCT02020369|Secondary|Total Amount of Study Drug Administered Per Mild/Moderate Bleeding Episode||Through study completion|Treated Population with non-missing measurements|||µg/kg per bleeding episode|Bleeding Episodes|Standard Deviation|Mean
2613479|NCT02020369|Secondary|Number of Administrations of Study Drug Per Mild/Moderate Bleeding Episode||Within 24 hours of Bleeding Episode|Treated Population with non-missing measurements|||Number of Administrations of Study Drug|Bleeding episodes|Standard Deviation|Mean
2613480|NCT02020369|Secondary|"Time to Assessment of a Good or Excellent Response of Mild/Moderate Bleeding Episodes by the Patient"|"Categories of Response to Treatment are Described as Follows:~None: No noticeable effect of the treatment on the bleed or worsening of patient's condition. Continuation of treatment with the study drug was needed.~Moderate: Some effect of the treatment on the bleed was noticed, e.g., pain decreased or bleeding signs improved, but bleed continued and required continued treatment with the study drug. Good: Symptoms of bleed (e.g., swelling, tenderness, and decreased range of motion in the case of musculoskeletal haemorrhage) had largely been reduced by the treatment, but had not completely disappeared. Symptoms had improved enough to not require more infusions of the study drug.~Excellent: Full relief of pain and cessation of objective signs of bleed (e.g., swelling, tenderness, and decreased range of motion in the case of musculoskeletal haemorrhage). No additional infusion of study drug was required."|Within 24 hours of Bleeding Episode|Treated Population with non-missing measurements|||Hours|Bleeding Episodes with event|95% Confidence Interval|Median
2613481|NCT02020369|Secondary|"Proportion of Mild/Moderate Bleeding Episodes With Patient (Pt)-Reported Good or Excellent Responses at 12 Hours"|"Based on Patient-Reported Good or Excellent responses as per the below descriptions:~Good: Symptoms of bleed (e.g., swelling, tenderness, and decreased range of motion in the case of musculoskeletal haemorrhage) had largely been reduced by the treatment, but had not completely disappeared. Symptoms had improved enough to not require more infusions of the study drug.~Excellent: Full relief of pain and cessation of objective signs of bleed (e.g., swelling, tenderness, and decreased range of motion in the case of musculoskeletal haemorrhage). No additional infusion of study drug was required."|at 12 hours|Treated Population|||Pt-reported proportion success of BEs|Bleeding Episodes (BEs)|95% Confidence Interval|Number
2613482|NCT02020369|Primary|Proportion of Successfully Treated Mild/Moderate Bleeding Episodes|"For the primary efficacy endpoint, successful treatment of a bleeding episode was defined as a combination of the following:~Good or Excellent response noted by the patient~Study drug treatment: No further treatment with study drug beyond timepoint for this bleeding episode~No other hemostatic treatment needed for this bleeding episode~No administration of blood products that would indicate continuation of bleeding beyond timepoint~No increase of pain beyond timepoint that could not otherwise be explained"|12 hours after first administration of study drug|Treated Population|||Proportion of Success of BEs|Bleeding Episodes (BEs)|95% Confidence Interval|Number
2613483|NCT02020304|Secondary|Pruritus|patients reporting pruritis at 30 minutes after CSE injection, self reported and measured on a scale of 0 (no itching at all) up to 10 (itching as bad as can be imagined)|30 minutes||||units on a scale||Standard Deviation|Mean
2613484|NCT02020304|Secondary|Analgesia Onset-15 Minutes Post Injection||up to 3 hours|number of subjects who achieved a VAS pain score of </= 3 at 15 minutes after injection|||Participants|||Count of Participants
2613488|NCT02020278|Secondary|Change From Baseline In Bilirubin For Participants On Tolvaptan At Month 2|No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected. Data reported only include assessments made for bilirubin during the Core Safety Follow-up Component of the trial. Results are reported in micromoles (umol)/L.|Baseline, Month 2|All enrolled participants with analyzable data at specified timepoint. No enrolled participant received any investigational medicinal product during the study.|||umol/L||Standard Deviation|Mean
2613489|NCT02020278|Secondary|Change From Baseline In Alanine Aminotransferase (ALT) And Aspartate Aminotransferase (AST) For Participants On Tolvaptan At Month 2|No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected. Data reported only include assessments made for ALT and AST during the Core Safety Follow-up Component of the trial. Results are reported in units/liter (U/L).|Baseline, Month 2|All enrolled participants with analyzable data at specified timepoint. No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected.|||U/L||Standard Deviation|Mean
2613490|NCT02020278|Secondary|Change From Baseline In Growth Percentiles For Body Height And Weight At Month 6|Changes from baseline in growth percentiles for body height and weight were calculated and are reported.|Baseline, Month 6|All enrolled participants with analyzable data at specified timepoint. No enrolled participant received any investigational medicinal product during the study.|||percentile||Standard Deviation|Mean
2613491|NCT02020278|Secondary|Participants With A Tanner Staging Score Of 1 At Month 6|Tanner Staging assessment consists of 2 domains (pubic hair and breast development) for girls and 3 domains (pubic hair, penis development, and testes development) for boys. Staging was based on a single score summarizing the domains (not individual domain scores). Stages range from 1-5, with 1 indicating preadolescent and 5 adult. Participants with a Tanner staging score of 1 (preadolescent) at Month 6 are reported.|Month 6|All enrolled participants with analyzable data at specified timepoint. No enrolled participant received any investigational medicinal product during the study.|||Participants|||Count of Participants
2613492|NCT02020278|Secondary|Plasma Concentrations Of Tolvaptan And Metabolites In Participants Who Had Continued Tolvaptan Therapy For Eight Consecutive Weeks|No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure.|8 Weeks|No enrolled participant received any investigational medicinal product during the study. Due to early study termination, no pharmacokinetic analyses were performed.||||||
2613493|NCT02020278|Secondary|Percentage Of Participants With Overly Rapid Correction In Serum Sodium 24 Hours After The First Dose At Introduction Or Reintroduction Of Tolvaptan|No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure.|Month 6|No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected.||||||
2613494|NCT02020278|Secondary|Change From Baseline In PedsQL Multidimensional Fatigue Scale (MFS) Total Score At Month 6|The PedsQL GCS was used for quality of life assessment. It is appropriate for at least 2 years of age, however availability may be limited for certain ages and languages. It encompasses 4 dimensions of functioning (physical, emotional, social, school). The age groups covered are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Adolescent (13-18 years). Depending on the participant's age, the questionnaire may be completed by either the participant or the parent/caregiver, as appropriate. For the Toddler group, the PedsQL GCS consists of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consists of 23 items, with a 3-point Likert scale (0, 2, 4) for the Young Child, and a 5-point Likert scale for the Child and Adolescent groups. Scores are transformed on a scale from 0 to 100 and averaged. Higher scores indicate improved quality of life. The change from baseline in summed emotional, social, and school dimensions is presented.|Baseline, Month 6|All enrolled participants with analyzable data at specified timepoint. No enrolled participant received any investigational medicinal product during the study.|||units on a scale||Full Range|Mean
2613495|NCT02020278|Secondary|Change From Baseline In PedsQL GCS Psychosocial Health Summary Score At Month 6|The PedsQL GCS was used for quality of life assessment. It is appropriate for at least 2 years of age, however availability may be limited for certain ages and languages. It encompasses 4 dimensions of functioning (physical, emotional, social, school). The age groups covered are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Adolescent (13-18 years). Depending on the participant's age, the questionnaire may be completed by either the participant or the parent/caregiver, as appropriate. For the Toddler group, the PedsQL GCS consists of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consists of 23 items, with a 3-point Likert scale (0, 2, 4) for the Young Child, and a 5-point Likert scale for the Child and Adolescent groups. Scores are transformed on a scale from 0 to 100 and averaged. Higher scores indicate improved quality of life. The change from baseline in summed emotional, social, and school dimensions is presented.|Baseline, Month 6|All enrolled participants with analyzable data at specified timepoint. No enrolled participant received any investigational medicinal product during the study.|||units on a scale||Full Range|Mean
2613496|NCT02020278|Secondary|Change From Baseline In PedsQL GCS Physical Health Summary Score At Month 6|The PedsQL GCS was used for quality of life assessment. It is appropriate for at least 2 years of age, however availability may be limited for certain ages and languages. It encompasses 4 dimensions of functioning (physical, emotional, social, school). The age groups covered are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Adolescent (13-18 years). Depending on the participant's age, the questionnaire may be completed by either the participant or the parent/caregiver, as appropriate. For the Toddler group, the PedsQL GCS consists of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consists of 23 items, with a 3-point Likert scale (0, 2, 4) for the Young Child, and a 5-point Likert scale for the Child and Adolescent groups. Scores are transformed on a scale from 0 to 100 and averaged. Higher scores indicate improved quality of life. The change from baseline in the physical health dimension is presented.|Baseline, Month 6|All enrolled participants with analyzable data at specified timepoint. No enrolled participant received any investigational medicinal product during the study.|||units on a scale||Full Range|Mean
2613497|NCT02020278|Secondary|Change From Baseline In Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale (GCS) Total Score At Month 6|The PedsQL GCS was used for quality of life assessment. It is appropriate for at least 2 years of age, however availability may be limited for certain ages and languages. It encompasses 4 dimensions of functioning (physical, emotional, social, school). The age groups covered are: Toddler (2-4 years), Young child (5-7 years), Child (8-12 years), and Adolescent (13-18 years). Depending on the participant's age, the questionnaire may be completed by either the participant or the parent/caregiver, as appropriate. For the Toddler group, the PedsQL GCS consists of 21 items, using a 5-point Likert scale (0 to 4); for all other groups, the PedsQL GCS consists of 23 items, with a 3-point Likert scale (0, 2, 4) for the Young Child, and a 5-point Likert scale for the Child and Adolescent groups. Scores are transformed on a scale from 0 to 100 and averaged. Higher scores indicate improved quality of life. The change from baseline in the GCS total score is presented.|Baseline, Month 6|All enrolled participants with analyzable data at specified timepoint. No enrolled participant received any investigational medicinal product during the study.|||units on a scale||Full Range|Mean
2613498|NCT02020278|Secondary|Percentage Of Participants Requiring Continuation Of Tolvaptan Following 30 Days Of Treatment|No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure.|Month 6|No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected.||||||
2613499|NCT02020278|Secondary|Percentage Of Participants Who Had Recurrence Of Hyponatremia While On Tolvaptan|No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure.|Month 6|No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected.||||||
2613500|NCT02020278|Secondary|Percentage Of Participants Who Required Rescue Therapy While On Tolvaptan Treatment|No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure.|Month 6|No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected.||||||
2613501|NCT02020278|Primary|Change From Baseline At Month 6 In Serum Sodium While Tolvaptan Was Being Administered|No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected for this outcome measure.|Baseline, Month 6|No enrolled participant received any investigational medicinal product during the study. Due to early study termination, efficacy data were not collected.||||||
2613502|NCT02020135|Primary|Overall Radiologic Response|Overall radiologic response was measured at baseline and post-baseline. Imaging techniques used at screening were used throughout the study. The preferred imaging techniques include: bone scan, contrast enhanced CT of chest, contrast enhanced CT of pelvis, and contrast enhanced CT of upper & lower abdomen. Best overall radiologic response (confirmed), target and non-target lesions, was defined as responses in bone, visceral or nodal metastases according to the Modified Response Evaluation Criteria (RECIST 1.1). The best overall radiologic response is the best response recorded from the start of the treatment until disease progression/recurrence (taking, as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject's best response assignment depended on the achievement of both measurement and confirmation criteria.|25 weeks|Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). All subjects (n=9) enrolled in 2301EXT were evaluated.|||% of subjects|||Number
2613503|NCT02020135|Primary|CTC Response|Circulating tumor cells (CTC) response was measured at baseline and had at least one post-baseline assessment. Response was assessed as the maximum decrease over the extension study. Response was defined as any decrease from baseline of at least 50%.|25 weeks|Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a CTC baseline value and at least one post-baseline value.|||% of responders|||Number
2613504|NCT02020135|Primary|Percentage of Participants With Total Serum PSA Response|Total serum PSA (prostate-specific antigen) was measured at baseline and had at least one post-baseline assessment. PSA response was examined at two levels: at least 30% decrease or at least 50% decrease in serum PSA. Response was assessed as the maximum decrease over the extension study. Response was defined as any decrease from baseline of at least 30% or 50%.|25 Weeks|Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a PSA baseline value and at least one post-baseline value.|||% of responders|||Number
2613505|NCT02020031|Primary|Mean Concentration of Vancomycin in Bone Samples|During the procedure, bone samples (approximately 0.5 cm^3) were taken at regular intervals were taken at regular intervals until skin closure. All bone samples were taken from the femur, distant from the tibial intraosseous injection site. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision.|baseline to 24 hours||||µg/g||Standard Deviation|Mean
2613506|NCT02020031|Primary|Mean Concentration of Vancomycin in Subcutaneous Fat|During the procedure, subcutaneous fat samples (approximately 0.5 cm^3) were taken at regular intervals until skin closure. Vancomycin concentrations were determined by liquid chromatography coupled with tandem mass spectrometry. Times are given as minutes post surgical incision.|Baseline to 24 hours||||µg/g||Standard Deviation|Mean
2613507|NCT02020018|Other Pre-specified|Length of Stay|Length of stay was defined as the number of nights spent in the hospital after surgery.|postoperative to discharge|Data for this outcome measure was not collected.||||||
2613508|NCT02020018|Secondary|Reoperation for Wound Infection|The total number of reoperations required due to infection.|30 days post surgery|Data on reoperation was not collected.||||||
2613509|NCT02020018|Primary|Wound Infection After Open Heart Surgery|The total number of participants with surgical site infections after cardiac surgery.|30 days post-surgery||||Participants|||Count of Participants
2616961|NCT01985685|Primary|Change in VO2 Over Time|The primary outcome will be the change in VO2 over the 6 hours after administration of the study medication, adjusted for baseline VO2.|6 hrs||||ml/kg/min||Inter-Quartile Range|Median
2613517|NCT02019940|Primary|Change in Clinician Administered PTSD Scale (CAPS)|The CAPS is a standardized clinician-rated instrument to assess the presence and severity of PTSD symptoms. The scores range from 0 (minimum) to 80 (mazimum). Higher scores reflect worse symptoms.|Change from baseline to 12 weeks|18 participants started the study and 9 participants were randomized into the single arm of the study. However, only 8 participants completed the treatment. Since there was some treatment data collected on the 9th participant, he/she was included in the analysis.|||units on a scale||Standard Deviation|Mean
2613518|NCT02019927|Secondary|Symbol Digit Modality Testing|Scores range from 0-110 with higher scores meaning better visual information processing speed|Change from Baseline to 1 - week post initial treatment||||score on a scale - change from baseline||95% Confidence Interval|Mean
2613519|NCT02019927|Secondary|National Eye Institute's Visual Functioning Questionnaire - 25|Test to measure Unweighted of scores within test ranging from 0-100 with higher scores meaning better outcome|Change from Baseline to 1 - week post initial treatment||||score on a scale - change from baseline||95% Confidence Interval|Mean
2613520|NCT02019927|Secondary|Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Center Quadrant|Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline|Change from Baseline (week 1) to 1 - week post initial treatment (week 8)||||um||95% Confidence Interval|Mean
2613521|NCT02019927|Secondary|Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Temporal Quadrant|Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline|Change from Baseline (week 1) to 1 - week post initial treatment (week 8)||||um||95% Confidence Interval|Mean
2613522|NCT02019927|Secondary|Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Inferior Quadrant|Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline|Change from Baseline (week 1) to 1 - week post initial treatment (week 8)||||um||95% Confidence Interval|Mean
2613523|NCT02019927|Secondary|Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Nasal Quadrant|Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline|Change from Baseline (week 1) to 1 - week post initial treatment (week 8)||||um||95% Confidence Interval|Mean
2613524|NCT02019927|Secondary|Ocular Coherent Tomography, Retinal Nerve Fiber Layer Thickness in Superior Quadrant|Assessed the change in thickness of the retinal nerve fiber layer 1-week post treatment compared to baseline|Change from Baseline (week 1) to 1 - week post initial treatment (week 8)||||um||95% Confidence Interval|Mean
2613525|NCT02019927|Secondary|Visual Field Mean Deviation|The Humphrey 24-2 Swedish Interactive Threshold Algorithm Standard perimeter was used to test visual field. Reported values are a change from baseline to 1-week post initial treatment.|Change from Baseline (week 1) to 1 - week post initial treatment (week 8)||||Decibels (dB)||95% Confidence Interval|Mean
2613526|NCT02019927|Secondary|Intra-Ocular Pressure (IOP)|Measured by Applanation (Galdmann) Tonometry method|Change from Baseline (week 1) to 1-week post initial treatment (week 8)||||mmHg||95% Confidence Interval|Mean
2613527|NCT02019927|Primary|Evaluation of the Effectiveness and Safety of Transcorneal Electrical Stimulation to Improve Visual Acuity|The primary outcomes are change in high-contrast LogMar VA from baseline (week 1) to initial post treatment (week 8). Participants read letters from a chart and receive 1 point for each letter correctly identified. Scores are converted to logMAR scale and analyzed for changes in visual acuity. Improvement in visual acuity is defined as a decrease in logMAR of 0.2 or more.|Change from Baseline (week 1) to 1-week post initial treatment (week 8)||||logMAR||95% Confidence Interval|Mean
2613528|NCT02019758|Secondary|Mean Peak Eosinophil Count (Aim 2)|This will assess the mean peak level of esophageal eosinophilia on biopsy (measured in peak eosinophil count - eos/hpf) at the time of recurrence|Symptom recurrence or 1 year after completing the initial 8 week treatment|This population reflects only those patients who achieved histologic remission (<15 eosinophils per high-power field) after the blinded phase, entered the observation phase, and had endoscopic and histologic outcome data.|||eosinophils per high-power field||Standard Deviation|Mean
2613529|NCT02019758|Secondary|Mean Endoscopic Severity Score at Recurrence (Aim 2)|Measurement of endoscopic severity, using the EoE Endoscopic Reference Score (EREFS) measure, at the time of recurrence. EREFS is a validated endoscopic severity score of key EoE endoscopic features (exudates, rings, edema, furrows, and strictures), and ranges from 0-9 with higher scores indicating higher endoscopic severity.|Symptom recurrence or 1 year after completing the initial 8 week treatment|This population reflects only those patients who achieved histologic remission (<15 eosinophils per high-power field) after the blinded phase, entered the observation phase, and had endoscopic and histologic outcome data.|||score on a scale||Standard Deviation|Mean
2613530|NCT02019758|Secondary|Number of Subjects With Histologic Recurrence, Defined as ≥15 Eosinophils Per High-power Field, at Follow-up Endoscopy.|To test whether OVB results in less histologic recurrence than fluticasone MDI, the number of subjects with ≥15 eosinophils per high-power field at follow-up endoscopy in each group will be compared using chi-square.|Symptom recurrence or 1 year after completing the initial 8 week treatment|This population reflects only those patients who achieved histologic remission (<15 eosinophils per high-power field) after the blinded phase, entered the observation phase, and had endoscopic and histologic data available.|||Participants|||Count of Participants
2613531|NCT02019758|Secondary|Median Number of Days Until Symptom Recurrence (Aim 2)|To test whether OVB results in less symptomatic recurrence than fluticasone MDI, the median number of days until symptom occurrence will be quantified between treatment end (week 8) and recurrent symptoms or study end (week 60) as the time of interest. Hazard ratio will be calculated using Cox proportional modeling.|Symptom recurrence or 1 year after completing the initial 8 week treatment|This population reflects only those patients who achieved histologic remission (<15 eosinophils per high-power field) after the blinded phase, entered the observation phase, and had symptom outcome data.|||Days||Standard Error|Median
2613532|NCT02019758|Secondary|Post-treatment Medication Compliance (Aim 1)|Medication compliance as measured by the percentage of medication appropriately used in each arm. For the slurry, this percentage is calculated after measuring the residual volume. For the inhaler, this percentage is calculated after measured using the residual weight.|8 weeks||||Percentage of medication used|||Number
2616973|NCT01985425|Secondary|New Onset Atrial Flutter|Replacement of the consistent P waves on 12-lead ECG, or documented telemetry tracing, by saw-tooth flutter waves.|Post-operative Day 1 until Postoperative Day 30||||Participants|||Count of Participants
2613533|NCT02019758|Secondary|Post-treatment Symptom Severity (Aim 1)|Post-treatment symptoms severity will be assessed with the EoE Symptom Activity Index (EEsAI), a validated dysphagia severity measure. The EEsAI ranges from 0-100, with higher scores indicating more severe symptoms; symptom remission is defined by a score <20.|8 weeks||||score on a scale||Standard Deviation|Mean
2613534|NCT02019758|Secondary|Percentage of Participants With Histologic Response of <15 Eos/Hpf|Percentage with histologic response, with response defined as <15 eos/hpf, will be compared between groups|8 weeks||||Percent responders|||Number
2613535|NCT02019758|Secondary|Post-treatment Endoscopic Severity (Aim 1)|Endoscopic severity will be quantified using the EoE Endoscopic Reference Score (EREFS) and compared between the two treatment arms. EREFS is a validated endoscopic severity score of key EoE endoscopic features (exudates, rings, edema, furrows, and strictures), and ranges from 0-9 with higher scores indicating higher endoscopic severity.|8 weeks||||score on a scale||Standard Deviation|Mean
2613536|NCT02019758|Primary|Post-treatment Dysphagia Score (Aim 1)|To determine whether viscous budesonide is more effective than fluticasone MDI for improving dysphagia (measured by the Daily Symptoms Questionnaire (DSQ)) in patients with EoE. The mean DSQ scores will be compared between the OVB and MDI groups using a two-sample t-test. The DSQ is a dysphagia severity score which ranges from 0-84, with higher numbers indicating more severe symptoms.|8 weeks||||score on a scale||Standard Deviation|Mean
2613537|NCT02019758|Primary|Post-Treatment Maximum Eosinophil Count (Aim 1)|To determine whether viscous budesonide is more effective than fluticasone MDI for improving post-treatment maximum esophageal eosinophil counts (measured in eosinophils per high powered field (eos/hpf)) in patients with eosinophilic esophagitis (EoE). The mean post-treatment maximum eosinophil count will be compared between the OVB and MDI groups using a two-sample t-test.|8 weeks||||eosinophils per high-power field||Standard Deviation|Mean
2613538|NCT02019719|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings Upto Week 4|Full 12-lead ECGs included heart rate, PR, QRS, QT and QTc intervals. Measurements were taken from the participant while in a supine position. ECGs were performed consistently either before or after dialysis throughout the study. ECG abnormalities characterized as abnormal-not clinically significant (A-NCS) and abnormal-clinically significant (A-CS) upto W4 have been presented.|Upto Week 4|Safety population.|||Participants|||Count of Participants
2613539|NCT02019719|Secondary|Number of Participants With Vital Sign Parameter Heart Rate (HR) of PCI Upto Week 4|Vital sign HR was recorded pre-dialysis and post-dialysis. Measurements were taken from the participant while in a seated position or semi-supine in the dialysis chair. PCI range for HR was < 40 or > 110 beats per minute. Participant's with values higher than the PCI range have been presented.|Upto Week 4|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2613540|NCT02019719|Secondary|Number of Participants With Vital Signs Parameters Systolic and Diastolic Blood Pressure (SBP,DBP) of PCI Upto Week 4|Vital signs SBP and DBP were recorded pre-dialysis and post-dialysis. Measurements were taken from the participant while in a seated position or semi-supine in the dialysis chair. PCI range for SBP was < 85 or > 170 and for DBP was < 45 or > 100 millimeters of mercury. Participant's with values high and low from the PCI range have been presented.|Upto Week 4|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2613541|NCT02019719|Secondary|Number of Participants With Chemistry and Hematology Data of Potential Clinical Importance (PCI) Upto Week 4|The PCI range was as follows: alkaline phosphates >= 3 times upper limit of normal range [ULRR]), potassium (>0.5 millimoles/liter below the LLRR or >1.0 millimoles/liter above the ULRR), phosphate (>0.323 millimoles/liter above ULRR or below lower limit reference range [LLRR]), glucose (<3.9 or >22 millimoles/liter), magnesium (<LLRR or > 0.3 milimoles/liter above ULRR), lymphocytes <0.5x LLRR, neutrophils (<0.5 times LLRR), platelets (80 or >500 times giga/liter), platelets (80 or >500 times giga/liter) and leukocytes >1 x giga/liter below the LLRR or >5 x GI/L above the ULRR. The participants who had PCI values higher and lower than the reference range have been presented.|Upto Week 4|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2613542|NCT02019719|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) on Therapy|An AE is defined as any untoward medical occurrence in clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any AE which results in death; is life-threatening; requires participant hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.|Upto Week 4|Safety population.|||Participants|||Count of Participants
2613543|NCT02019719|Secondary|Plasma Pharmacokinetic Concentration of GSK1278863 and Metabolites (M) at Week 4|Blood samples for plasma pharmacokinetic analysis were collected at Week 4 (pre-dose, 1, 2, 3 hours post-dose). Individual plasma GSK1278863 and M-GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531401, GSK2531403 concentrations have been presented.|Week 4|Pharmacokinetic Population: All participants from whom a Pharmacokinetic sample was obtained and analyzed. Only those participants available at the indicated time points were analyzed.|||micrograms/liter||Standard Deviation|Mean
2613544|NCT02019719|Secondary|Percent CFB in Transferrin Saturation (TS) at Week 4|TS was used as marker of iron metabolism and utilization. Baseline was defined as the value on Day 1. Percent CFB was calculated as 100 multiplied by the exponential mean change on a log scale minus 1.|Baseline (Day 1) and Week 4|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Percent change||95% Confidence Interval|Geometric Mean
2613545|NCT02019719|Secondary|CFB in Transferrin at Week 4|Transferrin was used as marker of iron metabolism and utilization. Baseline was defined as the value on Day 1. CFB was calculated by subtracting the Baseline value from the post-dose value at Week 4.|Baseline (Day 1) and Week 4|ITT population. Only those participants with data available at the indicated time points were analyzed.|||grams/liter||Standard Deviation|Mean
2613896|NCT02015676|Secondary|Time to Treatment Response|The median time, in months, from the start of treatment to treatment response event.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||months||95% Confidence Interval|Median
2613546|NCT02019719|Secondary|CFB in Total Iron Binding Capacity [TIBC], Unbound Iron Binding Capacity [UIBC] and Iron at Week 4|TIBC, UIBC and Iron were used as marker of iron metabolism and utilization. Baseline was defined as the value on Day 1. CFB was calculated by subtracting the Baseline value from the post-dose value at Week 4.|Baseline (Day 1) and Week 4|ITT population. Only those participants available at the specified time points were analyzed.|||micromoles/liter||Standard Deviation|Mean
2613547|NCT02019719|Secondary|CFB in Ferritin at Week 4|Ferritin was used as marker of iron metabolism and utilization. Baseline was defined as the value on Day 1. CFB was calculated by subtracting the Baseline value from the post dose value at Week 4.|Baseline (Day 1) and Week 4|ITT population. Only those participants with data available at the specified time points were analyzed.|||micrograms/liter||Standard Deviation|Mean
2613548|NCT02019719|Secondary|Percent CFB in Hepcidine Upto Week 4|Blood samples for hepcidine were collected on Day 1 (pre-dose), Week 2 (collected approximately 6-12 hours post-dose) and Week 4 (pre-dose). Baseline was defined as the value on Day 1. Percent CFB was calculated as 100 multiplied by the exponential mean change on a log scale minus 1.|Baseline (Day 1) Upto Week 4|ITT population. Only those participants available at the specified time points were analyzed.|||Percent change||95% Confidence Interval|Geometric Mean
2613549|NCT02019719|Secondary|Maximum Observed Percent CFB in Peak Vascular Endothelial Growth Factor (VEGF) Upto Week 4|Blood samples for VEGF were collected on Day 1 (pre-dose), Week 2 (collected approximately 6-12 hours post-dose on arrival and after 1, 2 and 3 hours) and Week 4 (pre-dose and 3 hours post-dose). Maximum observed value meant maximum value between Week 1 and Week 4. Baseline was defined as the value on Day 1. Maximum observed percent CFB was calculated as 100 multiplied by the maximum observed exponential mean change on a log scale minus 1.|Baseline (Day 1) Upto Week 4|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Percent change||95% Confidence Interval|Geometric Mean
2613550|NCT02019719|Secondary|Maximum Observed CFB in Erythropoietin (EPO) Upto Week 4|Blood samples for EPO were collected on Day 1 (pre-dose), Week 2 (collected approx 6-12 hours post-dose on arrival and after 1, 2 and 3 hours) and Week 4 (pre-dose and 3 hours post-dose). Maximum observed value meant maximum value between Week 1 and Week 4. Baseline was defined as the value on Day 1. Maximum observed CFB was calculated by subtracting the Baseline value from the maximum observed value between Week 1 and Week 4.|Baseline (Day 1) Upto Week 4|ITT population. Only those participants with data available at the indicated time points were analyzed.|||International units/liter||Standard Deviation|Mean
2613551|NCT02019719|Secondary|Number of Participants Who Reached Pre-defined Hgb Stopping Criteria|Hgb stopping criteria was defined as: (1) Hgb <7.5 g/dL (2) 7.5 <= Hgb <1 3.0 g/dL and >2 g/dL Hgb change over 2W (3) Hgb >=13.0 g/dL. The number of participants who reached pre-defined Hgb stopping criteria have been presented.|Upto Week 4|ITT population.|||Participants|||Count of Participants
2613552|NCT02019719|Secondary|Percentage of Participants Who Achieved Hgb Response at Week 4|Hgb response was defined as achieving an increase of at least 0.5 g/dL, 1.0 g/dL, 1.5 g/dL, and 2.0 g/dL in Hgb. The percentage of participants with Hgb response: Hgb increase <-1.0, Hgb increase -1.0 -< -0.5, Hgb increase -0.5 -< 0.5, Hgb increase 0.5 -< 1.0 and Hgb increase >=1.0 have been presented.|Week 4|ITT population. Data for only those participants available at the indicated time points were collected and analyzed. Data points with null value for participants analyzed indicate data not collected for respective category and treatment arm.|||Percentage of participants|||Number
2613553|NCT02019719|Secondary|Number of Participants Who Achieved Hgb Response at Week 4|Hgb response was defined as achieving an increase of at least 0.5 g/dL, 1.0 g/dL, 1.5 g/dL, and 2.0 g/dL in Hgb. The number of participants with Hgb response: Hgb increase <-1.0, Hgb increase -1.0 -< -0.5, Hgb increase -0.5 -< 0.5, Hgb increase 0.5 -< 1.0 and Hgb increase >=1.0 have been presented.|Week 4|ITT population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2613554|NCT02019719|Secondary|CFB in Hgb Upto Week 8|Hgb assessments were performed at Baseline, Week 1, Week 2, Week 3, W eek4/Early withdrawal and Week 8 (follow-up) based on central laboratory (Quest diagnosis). Baseline was defined as the value on Day 1. CFB was calculated by subtracting the Baseline value from the post-dose value at Week 4.|Baseline (Day 1) Upto Week 8|ITT population. Only those participants available at the specified time points were analyzed.|||g/dL||Standard Deviation|Mean
2613555|NCT02019719|Primary|Change From Baseline (CFB) in Hemaglobin (Hgb) at Week 4|Baseline was defined as the value on Day 1. CFB was calculated by subtracting the baseline value from the post-dose value at Week 4. To model the dose-response relationship a four-parameter Emax model was used. E0 is the expected Hgb change from Baseline for a participant receiving placebo and experiencing the average Hgb Baseline observed in the study. Emax is the expected Hgb change from Baseline for a participant receiving the highest dose above which no further increase in response can be achieved. ED50 is the dose that attains the intermediate response. Gamma is the slope parameter. Minimal Effective Dose (MED) is defined as the smallest dose that achieves a placebo-corrected change of 0.5 g/dL over Week 4. Target dose (TD) is defined as the dose that achieves a placebo-corrected 1.0 g/dL change over Week 4. Maximum Acceptable Dose (MAD) is defined as the dose that achieves a placebo-corrected 2.0 g/dL change over Week 4.|Baseline (Day 1) and Week 4|Intent-to-Treat (ITT) population comprised of all randomized participants who received at least one dose of study drug, had a Baseline and at least one corresponding on treatment assessment. Only those participants with data available at the indicated time points were analyzed.|||grams/deciliter (g/dL)||Standard Error|Least Squares Mean
2613556|NCT02019667|Secondary|Results of Physical Examination at the End of the Study Drug and Placebo Treatment Periods|A physical examination was administered by a physician to subjects at the end of each six month treatment period, i.e., following completion of a six month period on SGS-742 or Placebo. Results of the examination ranged from 0-4 with scores defined as follows: 0=No observation; 1=Stable baseline findings; 2=New asymptomatic finding; 3=Patient reports some worsening of a baseline daily function associated with new finding; 4=Patient unable to carry out a baseline daily function associated with new finding|Six months|One subject withdrew prior to end of Phase 1|||Participants|||Count of Participants
2613678|NCT02018562|Secondary|Patient Satisfaction With a Talking Tracheostomy Tube|Participants were asked how satisfied they were with the tracheostomy tube. Will report the number of participants who indicated some level of satisfaction.|2 weeks|This outcome was assessed for all 22 participants who completed the intervention arm. No data was collected for any of the participants in control arm.|||Participants|||Count of Participants
2613557|NCT02019667|Secondary|Change From Baseline of TMS Measurement of Long Interval Intracortical Inhibition (Long ICI) at the End of the Study Drug and Placebo Treatment Periods|Transcranial Magnetic Stimulation (TMS) is a non-invasive technique which applies magnetic pulses to the brain via a coil inducing an electrical current in the brain. Stimulation is typically applied at a sufficient intensity to trigger action potentials in nearby neurons.Intracortical facilitation and inhibition were studied using a paired stimulus paradigm. The motor threshold (MT) was first established. The conditioning stimulus (70% MT) followed by the test stimulus (120% MT) was delivered at 100 ms for long ICI. Each run consisted of 10 trials, and the amplitude ratio of the mean conditioned Motor Evoked Potential (MEP) to control MEP was determined. A larger amplitude ratio indicates greater cortical excitability. The differences between Placebo and Baseline, and SGS and Baseline were obtained. These values were averaged across individuals to report a mean.|Baseline and Six months|We were unable to obtain Motor Thresholds for all participants at all three timepoints, resulting in different N for each time period. All available data is reported.|||ratio of MEP amplitude||Standard Deviation|Mean
2613558|NCT02019667|Secondary|Change From Baseline of TMS Measurement of Short Interval Intracortical Inhibition (Short ICI) at the End of the Study Drug and Placebo Treatment Periods|Transcranial Magnetic Stimulation (TMS) is a non-invasive technique which applies magnetic pulses to the brain via a coil inducing an electrical current in the brain. Stimulation is typically applied at a sufficient intensity to trigger action potentials in nearby neurons. Intracortical facilitation and inhibition were studied using a paired stimulus paradigm. The motor threshold (MT) was first established. The conditioning stimulus (70% MT) followed by the test stimulus (120% MT) was delivered at an interstimulus interval (ISI) of 2 ms for short ICI. Each run consisted of 10 trials, and the amplitude ratio of the mean conditioned Motor Evoked Potential (MEP) to control MEP was determined. A larger amplitude ratio indicates greater cortical excitability. The differences between Placebo and Baseline, and SGS and Baseline were obtained. These values were averaged across individuals to report a mean.|Baseline and Six months|We were unable to obtain Motor Thresholds for all participants at all three timepoints, resulting in different N for each time period. All available data is reported.|||ratio of MEP amplitude||Standard Deviation|Mean
2613559|NCT02019667|Secondary|Change From Baseline of TMS Measurement of Intracortical Facilitation at the End of the Study Drug and Placebo Treatment Periods|Transcranial Magnetic Stimulation (TMS) is a non-invasive technique which applies magnetic pulses to the brain via a coil inducing an electrical current in the brain. Stimulation is typically applied at a sufficient intensity to trigger action potentials in nearby neurons. Intracortical facilitation (ICF) and inhibition (ICI) were studied using a paired stimulus paradigm. The motor threshold (MT) was first established. The conditioning stimulus (70% MT) followed by the test stimulus (120% MT) was delivered at an interstimulus interval (ISI) of 10 ms for ICF. Each run consisted of 10 trials, and the amplitude ratio of the mean conditioned Motor Evoked Potential (MEP) to control MEP was determined. A larger amplitude ratio indicates greater cortical excitability. The differences between Placebo and Baseline, and SGS and Baseline were obtained. These values were averaged across individuals to report a mean.|Baseline and Six months|We were unable to obtain Motor Thresholds for all participants at all three timepoints, resulting in different N for each time period. All available data is reported.|||ratio of MEP amplitude||Standard Deviation|Mean
2613560|NCT02019667|Secondary|Change From Baseline of TMS Measurement of Motor Threshold at the End of the Study Drug and Placebo Treatment Periods|Transcranial Magnetic Stimulation (TMS) is a non-invasive technique which applies magnetic pulses to the brain via a coil inducing an electrical current in the brain. Stimulation is typically applied at a sufficient intensity to trigger action potentials in nearby neurons. The motor threshold is defined as the minimum percentage of the stimulator output that evoked a motor evoked potential of more than 50µV in at least 5 out of 10 trials. Motor threshold was measured at the end of the study drug period and the end of the Placebo period. The differences between Placebo and Baseline, and SGS and Baseline were obtained. A decrease from baseline value indicates increased cortical excitability and an increase from baseline value indicates reduced cortical excitability. These values were averaged across individuals to report a mean and standard deviation of this baseline-to-treatment period change. The mean for each treatment can be compared to have a baseline-adjusted treatment effect.|Baseline and Six months|We were unable to obtain Motor Thresholds for all participants at all three timepoints, resulting in different N for each time period. All available data is reported.|||percentage of stimulator output||Standard Deviation|Mean
2613561|NCT02019667|Primary|Change From Baseline on the Adaptive Behavior Assessment System (ABAS) Test at the End of the Study Drug and Placebo Treatment Periods|The ABAS questionnaire was completed by the participant's parent or caregiver at the end of each six month treatment period.The ABAS provides a comprehensive picture of adaptive skills across the lifespan. The questionnaire addresses Conceptual, Social and Practical skills including communication, self-direction, use of leisure time, health, safety and self-care. The General Adaptive Composite score ranges from <40 to >160 with a lower score representing lower adaptive behavior. The difference between Placebo and Baseline and Study Drug and Baseline were obtained. These values were averaged across individuals to report a mean and a standard deviation of the baseline-to-treatment period change. The means for each treatment can be compared to have a baseline-adjusted treatment effect interpretation. A positive change represents an improvement in adaptive skills compared with baseline and a negative change represents a decline in adaptive skills compared with baseline.|baseline and six months|The ABAS was not able to be completed for all participants.|||scores on a scale||Standard Deviation|Mean
2613562|NCT02019602|Secondary|The Plasma Concentration Level of Anti-CZP Antibodies in the Umbilical Cord(s) at Birth|Blood samples will be taken directly after delivery (within <= 1 hour) from the umbilical cord|Day 0|The Pharmacokinetic Set for Umbilical Cords (PKS-U) consisted of all umbilical cords of infants from which a CZP concentration sample was obtained at birth.|||units/mL||Full Range|Median
2613563|NCT02019602|Secondary|The Plasma Concentration Level of Anti-CZP Antibodies in the Mother at Delivery|Blood samples will be taken within 24 hours before/after delivery from the mothers|Day 0|The Pharmacokinetic Set for Mothers (PKS-M) consisted of all mothers who provided the CZP concentration sample at delivery.|||units/mL||Full Range|Median
2613564|NCT02019602|Secondary|The Plasma Concentration of Certolizumab Pegol (CZP) in the Umbilical Cord at Birth|Blood samples will be taken directly after delivery (within <= 1 hour) from the umbilical cord|Day 0|The Pharmacokinetic Set for Umbilical Cords (PKS-U) consisted of all umbilical cords of infants from which a CZP concentration sample was obtained at birth.|||µg/mL||Full Range|Median
2613565|NCT02019602|Secondary|The Ratio of Plasma Concentration of Certolizumab Pegol (CZP) Between the Infant(s) and Mother at Delivery/Birth|Blood samples were taken within 24 hours before/after delivery from the mothers and within 24 hours after birth from the infant(s). Values below limit of quantification (BLQ) are replaced by values of lower limit of quantification/2=0.016 in calculations of ratios, however if both concentrations for a subject are BLQ then the ratio for that subject will not be calculated.|Day 0|The number of subjects’ data analyzed is 28 since these are ratios for the infants and their mothers and for each ratio, we need both data. Please note that PK-PPS-I analysis set is defined as the number of infants which is 14 which is why it seems to have some discrepancies. This is due to the unique study design with mother and infant pair.|||ratio||Full Range|Median
2613566|NCT02019602|Secondary|The Plasma Concentration of Certolizumab Pegol (CZP) in the Mother at Delivery|Blood samples will be taken within 24 hours before/after delivery from the mothers.|Day 0|The Pharmacokinetic Set for Mothers (PKS-M) consisted of all mothers who provided the CZP concentration sample at delivery.|||µg/mL||Full Range|Median
2613567|NCT02019602|Primary|The Plasma Concentration of Certolizumab Pegol (CZP) in the Infant(s) at Birth|Blood samples will be taken within 24 hours after birth from the infant(s).|Day 0|Of the 16 infants in the SS-I, two were excluded from the Pharmacokinetic Per-Protocol Set for Infants (PK-PPS-I): one due to missing data at birth and one due to implausible PK data.|||µg/mL||Full Range|Median
2613568|NCT02019563|Secondary|MTA/FS Pulpotomy and RCT Treated Incisor Survival|Kaplan-Meier survival curves were generated for the MTA/FS pulpotomy and RCT treatment groups. One treated incisor was selected by random draw from each subject for survival analysis to preserve independence of observations. The log-rank test was used to statistically compare survival of incisors.|12 and 18 months|Four participants in the MTA/FS and two participants in the RCT group did not have data collected due to lost to follow-up. Remaining participants were censored if lost to follow-up, exfoliated, lost to trauma or had a non-occurrence of a failure before the trial end.|||Proportion of participants|||Number
2613569|NCT02019563|Secondary|Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 18 Months Post-procedure.|Pulp treated incisors presenting with spontaneous pain, tenderness to percussion, fistula/sinus tract, soft tissue swelling and/or pathological tooth mobility were considered unacceptable clinical outcomes.|18 months after the procedure||||Proportion of incisors|Participants||Number
2613570|NCT02019563|Secondary|Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Unacceptable Clinical Outcome at 12 Months Post-procedure.|Pulp treated incisors presenting with spontaneous pain, tenderness to percussion, fistula/sinus tract, soft tissue swelling and/or pathological tooth mobility were considered unacceptable clinical outcomes. Clinical outcomes between the MTA/FS pulpotomy and RCT groups were compared using Fisher's Exact test.|12 months after the procedure||||Proportion of incisors|Participants||Number
2613571|NCT02019563|Primary|Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcomes 18 Months Post-procedure.|Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract. Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.|18 months after the procedure||||Proportion of incisors|Participants||Number
2613572|NCT02019563|Primary|Comparison of MTA/FS Pulpotomy Versus RCT Treated Incisors With Acceptable Radiographic Outcome at 12 Months Post-procedure.|Two disinterested pediatric dentists classified each treated incisor into one of three outcomes: N=incisor without pathologic change; Po=pathologic change present, follow-up recommended; and Px=pathologic change present, extract. Incisors rated N or Po were considered an acceptable radiographic outcome while incisors rated as Px were considered unacceptable.|12 months after the procedure||||Proportion of incisors|Participants||Number
2613573|NCT02019550|Secondary|Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Scores to Week 8|The MusiQoL is a validated 31-item questionnaire describing 9 dimensions named according to its constitutive items:activities of daily living (8 items);psychological well-being (4 items);symptoms (3 items);friends relationships (4 items);family relationships (3 items);satisfaction with health care (RHCS 3 items);sentimental and sexual life (2 items);coping (2 items);and rejection (2 items). Each of the questions was answered using a 6-point Likert scale, defined as 1-Never/Not at all, 2-Rarely/A little, 3-Sometimes/Somewhat, 4-Often/A lot, 5-Always/Very much and 6-Not applicable. The scores of each dimension were obtained by computing mean of the item scores of dimension with negatively worded item scores reversed so that higher scores indicated higher health-related QoL. All 9 dimension scores were linearly transformed to a 0-100 scale,where higher score=higher health-related QoL. Global index score was computed as mean of the 9 dimension scores (range 0-100;higher score=higher QoL).|Baseline, up to Week 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed = subjects evaluable for this outcome, “Number Analyzed” = subjects evaluable for specified dimensions."|||score on a scale||Standard Deviation|Mean
2613574|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Ease of Use Based on User Trial Questionnaire (UTQ)|"The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as very difficult, difficult, neither easy nor difficult, easy, or very easy. Percentage of subjects who rated the overall use of device as very difficult, difficult or neither easy nor difficult were reported. Here results are presented by device sequence."|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
2613610|NCT02019277|Secondary|Number of Participants Receiving Second-Line Treatment by Treatment Type|Second-line anti-cancer treatment was initiated after disease progression on first-line therapy. Number of participants who started second-line of treatment by treatment type was reported. Participants who received combination treatment were counted for each treatment type.|Baseline up to approximately 35 months|Analysis was performed on the ITT population participants who started second-line of treatment.|||participants|||Number
2616974|NCT01985425|Secondary|Death||Post-operative Day 1 until Postoperative Day 30||||Participants|||Count of Participants
2613575|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Overall Satisfaction With the Injection Device Based on User Trial Questionnaire (UTQ)|"The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall satisfaction with using the device. Subjects responded as Strongly disagree, Disagree, Neither agree nor disagree, Agree, Strongly agree that they were satisfied with the device. Here results are presented by device sequence."|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
2613576|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Likelihood of Recommending the Device to Others Based on User Trial Questionnaire (UTQ)|"The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked they would recommend injection device to others needing REBIF therapy. Subjects responded as Very unlikely, Unlikely, Neutral/no opinion, Likely, Very likely. Here results are presented by device sequence."|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
2613577|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Level of Satisfaction With Information Provided by the Trainer Based on User Trial Questionnaire (UTQ)|"The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess whether the trainer provided easily understandable, unbiased and practical information about proper injection. Subjects responded as Strongly disagree, Disagree, Neither agree nor disagree, Agree, Strongly agree. Here results are presented by device sequence."|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
2613578|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Amount of Needle Anxiety While Using the Device Based on User Trial Questionnaire (UTQ)|"The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of anxiety while giving themselves an injection with device. Subjects assessed their anxiety as Not at all anxious, A little anxious, Moderately anxious, Very anxious, Extremely anxious. Here results are presented by device sequence."|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
2613579|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Minimization of Safety Hazards Based on User Trial Questionnaire (UTQ)|"The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess whether the device features help minimize safety hazards. Subjects responded as Strongly disagree, Disagree, Neither agree nor disagree, Agree, Strongly agree. Here results are presented by device sequence."|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
2613580|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Level of Convenience of Storing the Device Based on User Trial Questionnaire (UTQ)|"The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess how convenient it was to store the injection device. Subjects responded as Strongly disagree, Disagree, Neither agree nor disagree, Agree, Strongly agree that the device was convenient to store."|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome. Here results are presented by device sequence."|||percentage of subjects|||Number
2613581|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Level of Convenience of Using the Device Based on User Trial Questionnaire (UTQ)|"The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of convenience of using the device as Extremely inconvenient, Somewhat inconvenient, Neutral/no opinion, Somewhat convenient, or Extremely convenient. Here results are presented by device sequence."|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
2613582|NCT02019550|Secondary|Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device Away From Home Based on User Trial Questionnaire (UTQ)|"The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with using the device while away from home. Subjects assessed if they were satisfied with their ability to use the device while away from home as Strongly disagree, Disagree, Neither agree nor disagree, Agree, Strongly agree. Here results are presented by device sequence."|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed = subjects evaluable for this outcome, Number Analyzed=subjects evaluable at the specified time point."|||subjects|||Number
2613583|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Ease of Holding Based on User Trial Questionnaire (UTQ)|"The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with holding the device as very difficult, difficult, neither easy nor difficult, easy, or very easy. Here results are presented by device sequence."|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
2613584|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Number of Steps Involved in Completing the Injection Based on User Trial Questionnaire (UTQ)|"The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with respect to number of steps it took to complete an injection with the device. Subjects assessed if they were satisfied as Strongly disagree, Disagree, Neither agree nor disagree, Agree, Strongly agree. Here results are presented by device sequence."|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
2613585|NCT02019550|Secondary|Percentage of Subjects Rating Each Device on Amount of Time Needed to Complete the Injection Based on User Trial Questionnaire (UTQ)|"The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with respect to the amount of time it took to complete injection with the device. Subjects assessed if they were satisfied as Strongly disagree, Disagree, Neither agree nor disagree, Agree, Strongly agree. Here results are presented by device sequence."|Weeks 4 and 8|"FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here Number of Participants Analyzed signifies subjects evaluable for this outcome."|||percentage of subjects|||Number
2613586|NCT02019550|Secondary|Number of Subjects Rating Each Device on Level of Satisfaction With Using the Device While Traveling Based on User Trial Questionnaire (UTQ)|"The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their level of satisfaction with using the device while traveling (defined as being away from home overnight). Subjects assessed if they were satisfied with their ability to use the device while traveling overnight as Strongly disagree, Disagree, Neither agree nor disagree, Agree, Strongly agree. Here results are presented by device sequence."|Weeks 4 and 8|FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here “Number of Participants Analyzed” = subjects evaluable for this outcome, “Number Analyzed”=subjects evaluable at the specified time point.|||subjects|||Number
2613587|NCT02019550|Primary|"Percentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) up to Week 8"|"The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as very difficult, difficult, neither easy nor difficult, easy, or very easy. Percentage of subjects who rated the overall use of device as easy or very easy were reported. Here results are presented by device used."|Baseline up to Week 8|FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome.|||percentage of subjects|||Number
2613588|NCT02019550|Primary|"Percentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) at Week 8"|"The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as very difficult, difficult, neither easy nor difficult, easy, or very easy. Percentage of subjects who rated the overall use of device as easy or very easy were reported. Here results are presented by device sequence."|Week 8|FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome.|||percentage of subjects|||Number
2613589|NCT02019550|Primary|"Percentage of Subjects Rating Each Device as Easy/Very Easy to Use Based on User Trial Questionnaire (UTQ) at Week 4"|"The UTQ is a tool used to assess the ease-of-use of a device by the subject. Subjects were asked to assess their overall experience with using the device as very difficult, difficult, neither easy nor difficult, easy, or very easy. Percentage of subjects who rated the overall use of device as easy or very easy were reported. Here results are presented by device sequence."|Week 4|FAS included all relapsing remitting multiple sclerosis subjects who received at least 1 injection of Rebif using either Rebif Rebidose or Rebiject II and had at least 1 post-baseline evaluation/assessment. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome.|||percentage of subjects|||Number
2613590|NCT02019472|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24|The ACR 20 Response is defined as >= 20% improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20% improvement in 3 of following 5 assessments: subject's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), subject's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, subject's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum CRP.|Week 24|Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent.|||Percentage of participants|||Number
2613591|NCT02019472|Secondary|Percentage of Participants With Disease Activity Index Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Remission at Week 24|"The Disease Activity Index Score 28 using ESR [DAS28 (ESR)] is a derived score combining tender joints (28 joints), swollen joints (28 joints), ESR, and Patient's Global Assessment of Disease Activity. The 28 joints evaluated for swelling and tenderness were shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of the upper right and upper left extremities as well as the knee joints of the lower right and lower left extremities. The DAS28-ESR is expressed on a score range of 0-10, with the minimum score= 0 (best) to maximum score= 10 (worst). The DAS28 (ESR) remission is defined as a DAS28 (ESR) value of less than 2.6 at a visit."|Week 24|Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent.|||Percentage of participants|||Number
2616992|NCT01985321|Secondary|Number of Treatment Related Adverse Events||Days 1-28||||participants|||Number
2613592|NCT02019472|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24|The ACR 50 Response is defined as greater than or equal to (>=) 50 percent (%) improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >= 50% improvement in 3 of following 5 assessments: subject's assessment of pain using Visual Analog Scale (VAS) (0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), subject's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).|Week 24|Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent.|||Percentage of participants|||Number
2613593|NCT02019472|Primary|Change From Baseline in Disease Activity Index Score 28 (DAS28) Erythrocyte Sedimentation Rate (ESR) at Week 24|"The Disease Activity Index Score 28 using ESR [DAS28 (ESR)] is a derived score combining tender joints (28 joints), swollen joints (28 joints), ESR, and Patient's Global Assessment of Disease Activity. The 28 joints evaluated for swelling and tenderness were shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of the upper right and upper left extremities as well as the knee joints of the lower right and lower left extremities. The DAS28-ESR is expressed on a score range of 0-10, with the minimum score= 0 (best) to maximum score= 10 (worst)."|Baseline and Week 24|Full analysis set was defined as all randomized participants who received at least 1 (partial or complete) dose of study agent. Participants with missing DAS28 (ESR) at baseline were excluded from the analysis.|||units on a scale||Standard Deviation|Mean
2613594|NCT02019420|Secondary|Number of Participants Discontinuing Study Therapy Due to an Adverse Event (AE)|An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Safety analysis was based on actual treatment received and not randomization.|Up to 14 days|The safety set is all randomized participants who received any amount of study drug. A total of 4 participants were randomized to tedizolid but received linezolid.|||Participants|||Count of Participants
2613595|NCT02019420|Secondary|Number of Participants With ≥1 Adverse Events (AEs)|An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Safety analysis is based on actual treatment received instead of randomization.|Up to 32 days|The safety set is all randomized participants who received any amount of study drug. A total of 4 participants were randomized to tedizolid but received linezolid.|||Participants|||Count of Participants
2613596|NCT02019420|Secondary|Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiologically-Evaluable 2 (ME-2) Population|The number of patients in the ME-2 population with a favorable response at TOC was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator).|7-14 days after end of therapy - TOC|The ME-2 set is all mITT participants who did not receive an antibiotic (other than study drug) with activity against the baseline pathogen up to the TOC visit and is also in the clinically-evaluable (CE) set.|||Participants|||Count of Participants
2613597|NCT02019420|Secondary|Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (mITT) Population|The number of patients in the mITT population with a favorable response at TOC was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator).|7-14 days after end of therapy - TOC|The mITT set is all randomized, treated participants who have gram-positive pathogen(s) confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours (or 72 hours if MRSA) before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity.|||Participants|||Count of Participants
2613598|NCT02019420|Secondary|Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiologically-Evaluable 1 (ME-1) Population|The number of patients in the ME-1 population with a favorable response at EOT was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator).|1-3 days after completing study therapy (Days 8-10 or Days 15-17)|The ME-1 set is all mITT participants who did not receive an antibiotic (other than study drug) with activity against the baseline pathogen up to 28 days after randomization.|||Participants|||Count of Participants
2613599|NCT02019420|Secondary|Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiological Intent-to-Treat (mITT) Population|The number of patients in the mITT population with a favorable response at EOT was determined. Favorable response included eradication (absence of the baseline pathogen) and presumed eradication (no source specimen to culture in a participant assessed as a clinical cure by the investigator).|1-3 days after completing study therapy (Days 8-10 or Days 15-17)|The mITT set is all randomized, treated participants who have gram-positive pathogen(s) confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours (or 72 hours if MRSA) before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity.|||Participants|||Count of Participants
2613600|NCT02019420|Secondary|Number of Methicillin-Resistant Staphylococcus Aureus (MRSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population|The number of MRSA-infected participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Participants who had confirmed MRSA culture results from respiratory tract or pleural fluid specimens obtained within 72 hours of study Day 1 were included. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.|Up to 28 days|The MRSA-infected mITT set is all randomized, treated participants who have MRSA confirmed by respiratory tract/pleural fluid culture results obtained within 72 hours before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity.|||Participants|||Count of Participants
2617057|NCT01984398|Primary|Androxal Cmax Formulation A|To determine and compare the pharmacokinetic parameter Cmax between two formulations of Androxal|24 hours|Safety and PK populations are the same|||ng/mL||Standard Deviation|Mean
2613601|NCT02019420|Secondary|Number of Methicillin-Susceptible Staphylococcus Aureus (MSSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population|The number of MSSA-infected participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Participants who had confirmed MSSA culture results from respiratory tract or pleural fluid specimens obtained within 36 hours of study Day 1 were included. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.|Up to 28 days|The MSSA-infected mITT set is all randomized, treated participants who have MSSA confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours before first study drug dose, and documented bacterial pathogen against which the investigational drug has antibacterial activity.|||Participants|||Count of Participants
2613602|NCT02019420|Secondary|Clinical Response at Test of Cure (TOC) Visit in the Clinically-Evaluable (CE) Population|The clinical response in the CE population at the TOC visit (derived from the Investigator's assessment at the EOT and TOC visits) was determined by the investigator to be either: clinical success, clinical failure, or indeterminate. Clinical success was declared when most or all clinical signs were completely resolved, with no new signs of infection, no additional antibiotic therapy was required, and the participant was alive. Indeterminate was declared when the investigator could not determine success or failure. Clinical failure was declared with progression, relapse, or recurrence of new symptoms of infection, or a persistence or insufficient improvement in signs and symptoms of VNP.|7-14 days after end of therapy - TOC|The CE set is all randomized and treated participants who had assessment data available and did not have confounding events.|||Participants|||Count of Participants
2613603|NCT02019420|Secondary|Clinical Response at Test of Cure (TOC) Visit in the Intent-to-Treat (ITT) Population|The clinical response in the ITT population at the TOC visit (derived from the Investigator's assessment at the EOT and TOC visits) was determined by the investigator to be either: clinical success, clinical failure, or indeterminate. Clinical success was declared when most or all clinical signs were completely resolved, with no new signs of infection, no additional antibiotic therapy was required, and the participant was alive. Indeterminate was declared when the investigator could not determine success or failure. Clinical failure was declared with progression, relapse, or recurrence of new symptoms of infection, or a persistence or insufficient improvement in signs and symptoms of VNP.|7-14 days after end of therapy - TOC|The ITT set includes all randomized participants.|||Participants|||Count of Participants
2613604|NCT02019420|Secondary|Number of Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population|The numbers of participants with all-cause mortality within 28 days after randomization was determined in the mITT population. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.|Up to 28 days|The mITT set is all randomized, treated participants who have gram-positive pathogen(s) confirmed by respiratory tract/pleural fluid culture results obtained within 36 hours (or 72 hours if methicillin-resistant S. aureus [MRSA]) before first study drug dose, and bacterial pathogen against which the investigational drug has antibacterial activity.|||Participants|||Count of Participants
2613605|NCT02019420|Primary|Number of Participants With All-Cause Mortality in the Intent-to-Treat (ITT) Population|The numbers of participants with all-cause mortality within 28 days after randomization was determined in the ITT population. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.|Up to 28 days|The ITT set is all randomized participants.|||Participants|||Count of Participants
2613606|NCT02019277|Primary|Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Below 50%|LVEF was assessed using echocardiography (ECHO) or multiple-gated acquisition (MUGA) scans. Percentage of participants with LVEF below 50% at any time during the study was reported.|Baseline up to 28 days after last study drug administration (up to 36 months)|Analysis was performed on the Safety population.|||percentage of participants|||Number
2613607|NCT02019277|Primary|Percentage of Participants With AEs of Suspected Cardiac Origin, by New York Heart Association Classification (NYHA)|NYHA functional classification includes: Class I (no limitation in physical activity; ordinary physical activity does not cause fatigue, breathlessness or palpitation), Class II (slight limitation of physical activity; ordinary physical activity results in fatigue, palpitation, breathlessness or angina pectoris), Class III (marked limitation of physical activity; less than ordinary activity will lead to symptomatically 'moderate' heart failure) and Class IV (inability to carry out any physical activity without discomfort; symptoms of congestive cardiac failure are present even at rest). Percentage of participants with AEs suspected to be of cardiac origin by maximum NYHA classification was reported.|Baseline up to 28 days after last study drug administration (up to 36 months)|Analysis was performed on the Safety population.|||percentage of participants|||Number
2613608|NCT02019277|Primary|Percentage of Participants With AEs Leading to Premature Discontinuation of Investigational Medicinal Products (IMPs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Percentage of participants with AEs leading to premature discontinuation of IMPs (pertuzumab and trastuzumab) was reported. AEs included both SAEs and non-SAEs. The 95% CI was computed using Clopper-Pearson method.|Baseline up to 28 days after last study drug administration (up to 36 months)|Analysis was performed on the Safety population.|||percentage of participants||95% Confidence Interval|Number
2613609|NCT02019277|Primary|Percentage of Participants With AEs by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 Intensity Grades|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Intensity of AEs were graded according to NCI CTCAE version 4.0 on a 5-point scale: Grade 1=Mild, intervention not indicated; Grade 2=Moderate, local or noninvasive intervention indicated; Grade 3=Severe or medically significant but not immediately life-threatening; Grade 4= Life-threatening consequences, urgent intervention indicated; and Grade 5=Death related to AE. Percentage of participants with AEs by maximum severity grades was reported.|Baseline up to 28 days after last study drug administration (up to 36 months)|Analysis was performed on the Safety population.|||percentage of participants|||Number
2613611|NCT02019277|Secondary|OS During Second-Line of Treatment|The OS during second-line therapy was defined as the time from the start of second-line therapy (failure of first-line therapy) until death from any cause. Participants alive at the time of analysis and participants who were lost to follow-up were censored at their last clinical assessment date. Median OS during second-line therapy was estimated using Kaplan-Meier method. The 95% CI was computed using Brookmeyer and Crowley method.|From start of second-line of treatment (any time from baseline up to 35 months) up to death due to any cause or study end (up to approximately 36 months)|Analysis was performed on the ITT population participants who started second-line of treatment.|||months||95% Confidence Interval|Median
2613612|NCT02019277|Secondary|Percentage of Participants Who Died During Receiving Second-Line of Treatment|Percentage of participants who died from any cause during second-line of treatment was reported.|From start of second-line of treatment (any time from baseline up to 35 months) up to death due to any cause or study end (up to approximately 36 months)|Analysis was performed on the ITT population participants who started second-line of treatment.|||percentage of participants|||Number
2613613|NCT02019277|Secondary|Event-free Survival (EFS) Assessed According to RECIST Version 1.1|EFS was defined as the time from the start of treatment until the first documented initiation of non-protocol-specified treatment for metastatic breast cancer, PD, or death from any cause, whichever occurred first. Participants without treatment change, PD, death, or who were lost to follow-up at the time of analysis were censored at the date of the last tumor assessment when non-progression was documented or at the last date of follow-up, whichever was last. Participants without tumor assessment after baseline were censored at baseline unless death occurred before first scheduled tumor assessment. PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, and/or unequivocal progression of existing non-TLs, or appearance of 1 or more new lesions. Median EFS was estimated using Kaplan-Meier method. The 95% CI was computed using Brookmeyer and Crowley method.|Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months)|Analysis was performed on the ITT population.|||months||95% Confidence Interval|Median
2613614|NCT02019277|Secondary|Overall Survival (OS)|The OS was defined as the time from the start of treatment until death from any cause. Participants alive at the time of analysis and participants who were lost to follow-up were censored at their last clinical assessment date. Median OS was estimated using Kaplan-Meier method. The 95% CI was computed using Brookmeyer and Crowley method.|Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months)|Analysis was performed on the ITT population.|||months||95% Confidence Interval|Median
2613615|NCT02019277|Secondary|Percentage of Participants Who Died Due to Any Cause|Percentage of participants who died due to any cause during the study was reported.|Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months)|Analysis was performed on the ITT population.|||percentage of participants|||Number
2613616|NCT02019277|Secondary|Progression-free Survival (PFS) Assessed According to RECIST Version 1.1|PFS was defined as the time from start of treatment until first documented PD or death from any cause, whichever occurred first. Participants without PD, death, or who were lost to follow-up at the time of analysis were censored at the date of the last tumor assessment when non-progression was documented or at the last date of follow-up, whichever was last. Participants without tumor assessment data after the baseline were censored at baseline unless death occurred before first scheduled tumor assessment. PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, and/or unequivocal progression of existing non-TLs, or appearance of 1 or more new lesions. Median PFS was estimated using Kaplan-Meier method. The 95% CI was computed using Brookmeyer and Crowley method.|Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months)|Analysis was performed on the ITT population.|||months||95% Confidence Interval|Median
2613617|NCT02019277|Secondary|Percentage of Participants With PD (Assessed According to RECIST Version 1.1) or Death Due to Any Cause|For TLs, PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD, taking as reference the smallest SD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months)|Analysis was performed on the ITT population.|||percentage of participants|||Number
2613618|NCT02019277|Secondary|Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|BOR was defined as a confirmed CR or PR. All measurable lesions up to a maximum of 2 lesions per organ and 5 in total were identified as target lesions (TLs) and recorded at baseline. A sum of the diameters (longest for non-nodal lesions, short axis [SA] for nodal lesions) for all TLs was calculated as baseline sum of diameters (SD). All other lesions (or sites of disease) were identified as non-TLs and were recorded at baseline. CR was defined as the disappearance of all TLs and SA reduction to less than (<) 10 millimeter (mm) for nodal TLs/ non-TLs. PR was defined as greater than or equal to (>/=) 30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required. The 95% CI was computed using Clopper-Pearson method.|Baseline up to withdrawal of consent, loss to follow-up, disease progression, death, or study end (up to approximately 36 months)|Analysis was performed on ITT population. Only participants with measurable disease at baseline were included in the analysis. Participants without a post-baseline tumor assessment were considered non-responders.|||percentage of participants||95% Confidence Interval|Number
2613628|NCT02019264|Secondary|Time From Randomization to Conversion to T2DM for Participants Without Any Type of Diabetes at Baseline|The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.|Baseline up to end of study (Month 56)|The nondiabetes analysis set included all participants in the ITT set without a history of any type of diabetes at baseline.|||days||95% Confidence Interval|Median
2613736|NCT02017210|Secondary|Body FFM|"Body fat-free mass (FFM) from DXA change was determined as Follow-up Value - Baseline Value /Time between measurements. There were 2 time points 6 years apart"|6 years|DXA was performed in a sub-cohort of n=11, 11 and 19 in normal weight, overweight/obese insulin-sensitive and overweight/obese insulin-resistant participants, respectively|||kg/year||Inter-Quartile Range|Median
2613619|NCT02019277|Primary|Percentage of Participants With Adverse Events (AEs) and Serious AEs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Percentage of participants with AEs and SAEs was reported. AEs included both SAEs and non-SAEs. The 95% confidence interval (CI) was computed using Clopper-Pearson method.|Baseline up to 28 days after last study drug administration (up to 36 months)|Analysis was performed on the Safety population, which included all enrolled participants who received at least one dose of pertuzumab IV or trastuzumab SC.|||percentage of participants||95% Confidence Interval|Number
2613620|NCT02019264|Secondary|Change From Baseline in Echocardiographically-Determined Pulmonary Arterial Systolic Pressure||Baseline, Month 12|The ITT analysis set-participants in ECHO substudy included all randomized participants regardless of whether they took study drug or not. The ITT analysis set-participants in the ECHO substudy, where data was available at specified time points.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2613621|NCT02019264|Secondary|Percentage of Participants With FDA-Defined Valvulopathy at Baseline Who Demonstrated Worsened FDA-Defined Valvulopathy||Months 6 and 12|The ITT analysis set in participants with FDA-defined valvulopathy at baseline was used. The ITT analysis set in participants with FDA-defined valvulopathy at baseline where data was available at specified time point.|||percentage of participants|||Number
2613622|NCT02019264|Secondary|Percentage of Participants Who Met FDA-Defined Valvulopathy in Echocardiographically Determined Heart Valve Changes||Months 6 and 12|The FDA-defined valvulopathy analysis set included all participants in the ITT set without FDA-defined valvulopathy at baseline. The FDA-defined valvulopathy analysis set where data was available at specified time point.|||percentage of participants|||Number
2613623|NCT02019264|Secondary|Time From Randomization to Event of Improvement in Renal Function in Participants With T2DM at Baseline|Improvement in renal function was defined as first occurrence of regression of albuminuria or regression of CKD. Regression of albuminuria was defined as when participants with macroalbuminuria at baseline developed microalbuminuria or nonalbuminuria (ACR <30 mcg/mg in spot urine), or participants with microalbuminuria at baseline became nonalbuminuric, and ACR value decreased >= 30% from previous assessment during treatment. Regression of CKD defined as when participants with CKD Stage 1 or higher at baseline improved to normal or lower stages by NKF guidelines (eGFR >=90 with albuminuria at baseline improved to eGFR >=90 without albuminuria, or eGFR 60 to 89 at baseline became eGFR >=90 with or without albuminuria, or eGFR between 30 to 59 at baseline improved to >60 mL/min/1.73 BSA) during treatment. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.|Baseline up to end of study (Month 56)|The T2DM analysis set included all participants in the ITT set who had T2DM at baseline.|||days||95% Confidence Interval|Median
2613624|NCT02019264|Secondary|Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With T2DM at Baseline|New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria (ACR >=30 mcg/mg and ACR >=300 mcg/mg in spot urine), worsening albuminuria (microalbuminuria at baseline developed macroalbuminuria, ACR increased >=30% from baseline during treatment), CKD (eGFR >=90 mL/min/1.73 BSA and without kidney damage at baseline changed to CKD Stage 1/higher as per NKF Guidelines [2002]) or worsening of CKD (CKD Stage 1/higher as per NKF Guidelines [2002] worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times baseline value and >=1.5 mg/dL during treatment.), or any of the following: end-stage renal disease, renal transplant, renal death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.|Baseline up to end of study (Month 56)|The T2DM analysis set included all participants in the ITT set who had T2DM at baseline.|||days||95% Confidence Interval|Median
2613625|NCT02019264|Secondary|Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in Participants With Prediabetes at Baseline|New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria (ACR >=30mcg/mg and ACR >=300 mcg/mg in spot urine), worsening albuminuria (microalbuminuria at baseline developed macroalbuminuria, ACR increased >=30% from baseline during treatment), CKD (eGFR >=90 mL/min/1.73 BSA and without kidney damage at baseline changed to CKD Stage 1/higher as per NKF Guidelines [2002]) or worsening of CKD (CKD Stage 1/higher as per NKF Guidelines [2002] worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times baseline value and >=1.5 mg/dL during treatment.), or any of the following: end-stage renal disease, renal transplant, renal death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.|Baseline up to end of study (Month 56)|The prediabetes analysis set included all participants in the ITT set without a history of any type of diabetes and who were prediabetic at baseline.|||days||95% Confidence Interval|Median
2613626|NCT02019264|Secondary|Time From Randomization to Event of New Onset Renal Impairment or Worsening Existing Renal Impairment in All Participants|New onset/worsening of existing renal impairment was first occurrence of any events: microalbuminuria and macroalbuminuria (albumin-to-creatinine ratio [ACR] >=30mcg/mg and ACR>=300 mcg/mg in spot urine), worsening albuminuria (microalbuminuria at Baseline developed macroalbuminuria, ACR increased >=30% from Baseline during treatment), newly developed chronic kidney disease (CKD) (eGFR >=90 milliliter per minute per 1.73 [mL/min/1.73]body surface area (BSA) and without kidney damage at Baseline changed to CKD Stage 1/higher as per National Kidney Foundation [NKF] Guidelines [2002]) or worsening of CKD (CKD Stage 1/higher as per NKF Guidelines [2002] worsened to higher CKD stages during treatment), or doubling of serum creatinine (creatinine value at least 2 times Baseline value and >=1.5 mg/dL during treatment.), or any of the following: end-stage renal disease, renal transplant, renal death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.|Baseline up to end of study (Month 56)|The ITT set included all randomized participants regardless of whether they took study drug or not. This set was the same as the full analysis set.|||days||95% Confidence Interval|Median
2613627|NCT02019264|Secondary|Change From Baseline in HbA1c at Month 6 in Participants With T2DM at Baseline||Baseline, and Month 6|The T2DM analysis set included all participants in the ITT set who had T2DM at baseline. The T2DM analysis set where data was available at specified time points.|||percentage of HbA1c||Standard Deviation|Mean
2613629|NCT02019264|Secondary|Time From Randomization to Conversion to Normal Glucose Homeostasis in Participants With Prediabetes at Baseline|Normal glucose homeostasis was defined as HbA1c less than or equal to (<=) 5.6% and FPG < 100 mg/dL without any antidiabetic treatment. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.|Baseline up to end of study (Month 56)|The prediabetes analysis set included all participants in the ITT set without a history of any type of diabetes and who were prediabetic at baseline.|||days||95% Confidence Interval|Median
2613630|NCT02019264|Secondary|Time From Randomization to Event of All-cause Mortality|The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.|Baseline up to end of study (Month 56)|The total time analysis set used the ITT set, events were counted that occurred while participants were on and off treatment. Participants with no events were censored at their last study contact or at the visit following Sponsor Notification of Study Completion, whichever occurred first.|||days||95% Confidence Interval|Median
2613631|NCT02019264|Secondary|Time From Randomization to First Occurrence of the Individual Components of MACE+|The MACE+ events involved MI, stroke, or CV death or hospitalization for unstable angina or HF, or any coronary revascularization. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.|Baseline up to end of study (Month 56)|The total time analysis set used the ITT set, events counted occurred while participants were on and off treatment. Participants with no events were censored at last study contact or at the visit following Sponsor Notification of Study Completion, whichever first.|||days||95% Confidence Interval|Mean
2613632|NCT02019264|Secondary|Time From Randomization to Conversion to Type 2 Diabetes Mellitus (T2DM) for Participants With Prediabetes at Baseline|Time from randomization to conversion to T2DM was defined as first occurrence of any component of the 2013 American Diabetes Association (ADA) Diagnostic Criteria (ADA, 2013) in participants with prediabetes at baseline. The diagnostic criteria were met if a participant had unequivocal hyperglycemia (random plasma glucose greater than or equal to (>=) 200 milligram per deciliter (mg/dL) (11.1 millimole per liter [mmol/L]) with classic symptoms of hyperglycemia or hyperglycemic crisis) or any of the following criteria were observed and subsequently confirmed on repeat laboratory testing such as: glycosylated hemoglobin (HbA1c) >=to 6.5%; fasting plasma glucose (FPG) >=126 mg/dL (7.0 mmol/L); 2-hour plasma glucose >=200 mg/dL (11.1 mmol/L) by an oral glucose tolerance test (OGTT). The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.|Baseline up to end of study (Month 56)|Prediabetes and total time analysis set used ITT set: without a history of any type of diabetes and who were prediabetic at baseline; events were counted that occurred while participants were on, off treatment; participants with no events were censored at last study contact/at visit after notification of study completion, whichever occurred first.|||days||95% Confidence Interval|Median
2613633|NCT02019264|Primary|Time From Randomization to First Occurrence of MACE+|The MACE+ events involved MI, stroke, or CV death or hospitalization for unstable angina or heart failure (HF), or any coronary revascularization. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.|Baseline up to end of study (Month 56)|The total time analysis set used the ITT set, events were counted that occurred while participants were on and off treatment. Participants with no events were censored at their last study contact or at the visit following Sponsor Notification of Study Completion, whichever occurred first.|||days||95% Confidence Interval|Median
2613634|NCT02019264|Primary|Time From Randomization to First Occurrence of Major Adverse Cardiovascular Events (MACE) at Interim Analysis|The MACE events involved myocardial infarction (MI), stroke, or cardiovascular (CV) death. The outcome data was assessed using Kaplan-Meier estimate and Greenwood Formula.|Baseline up to Month 42|The total time analysis set using the intent-to-treat (ITT) set, events were counted that occurred while participants were on and off treatment. Participants with no events were censored at their last study contact or at the visit following sponsor notification of study completion, whichever occurred first.|||days||95% Confidence Interval|Median
2613635|NCT02019108|Secondary|Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Flexion Moment|"Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 acceptable (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed."|Weeks 0, 17, 21|Participants lost to follow-up. Gait modification group lost 3 participants by week 17 and 2 additional participants by week 21 making a total loss of 5. Walking Only group lost 6 participants by week 17 and 2 additional participants by week 21 making a total loss of 8.|||%Body Weight*Height||95% Confidence Interval|Least Squares Mean
2613636|NCT02019108|Secondary|Change From Baseline to Week 17 and From Baseline to Week 21 in Objective Physical Function as Measured by Timed Stair Climb.|"Participants were instructed to ascend 12 stairs as quickly as possible, and the fastest time from two attempts was recorded."|Weeks 0, 17, 21|Participants lost to follow-up. Gait modification group lost 3 participants by week 17 and 2 additional participants by week 21 making a total loss of 5. Walking Only group lost 6 participants by week 17 and 2 additional participants by week 21 making a total loss of 8.|||seconds||95% Confidence Interval|Least Squares Mean
2613637|NCT02019108|Secondary|Change From Baseline to Week 17 and From Baseline to Week 21 in Self-reported Physical Function as Measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale.|Lower-limb impairments will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a 24-item self-report questionnaire that quantifies pain (5 items), stiffness (2 items), and physical function (17 items). It is a valid, reliable, and responsive disease-specific self-report instrument and has been used in many knee OA studies. The WOMAC physical function subscale minimum value is 0 and maximum value is 68. Higher scores mean a worse outcome.|Weeks 0, 17, 21|Participants lost to follow-up. Gait modification group lost 2 participants by week 17 and 3 additional participants by week 21 making a total loss of 5. Walking Only group lost 3 participants by week 17 and 4 additional participants by week 21 making a total loss of 7.|||units on a scale||95% Confidence Interval|Least Squares Mean
2613676|NCT02018562|Secondary|Intensive Care Unit (ICU) Length of Stay|Measured in days|Time of discharge from the ICU (Approximately 6-8 months)||||days||Standard Deviation|Mean
2613677|NCT02018562|Secondary|Overall Hospital Length of Stay|Measured in days|Time of discharge from the hospital (Approximately 6-8 months)||||days||Standard Deviation|Mean
2613638|NCT02019108|Primary|Change From Baseline to Week 17 and From Baseline to Week 21 in Foot Progression Angle (FPA)|FPA indicates orientation of the foot with respect to the forward progression of the body. Positive values correspond to a toe-in orientation, whereas negative values correspond to a toe-out orientation. Therefore, a positive change value indicates more toe-in versus a negative change value indicates more toe-out.|Weeks 0, 17, 21|Participants lost to follow-up. Gait modification group lost 3 participants by week 17 and 2 additional participants by week 21 making a total loss of 5. Walking Only group lost 6 participants by week 17 and 2 additional participants by week 21 making a total loss of 8.|||degrees||95% Confidence Interval|Least Squares Mean
2613639|NCT02019108|Primary|Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Knee Adduction Moment Impulse|"Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 acceptable (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed."|Weeks 0, 17, 21|Participants lost to follow-up. Gait modification group lost 3 participants by week 17 and 2 additional participants by week 21 making a total loss of 5. Walking Only group lost 6 participants by week 17 and 2 additional participants by week 21 making a total loss of 8.|||%Body Weight*Height*seconds||95% Confidence Interval|Least Squares Mean
2613640|NCT02019108|Primary|Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: Second Peak Knee Adduction Moment|"Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 acceptable (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed."|Weeks 0, 17, 21|Participants lost to follow-up. Gait modification group lost 3 participants by week 17 and 2 additional participants by week 21 making a total loss of 5. Walking Only group lost 6 participants by week 17 and 2 additional participants by week 21 making a total loss of 8.|||%Body Weight*Height||95% Confidence Interval|Least Squares Mean
2613641|NCT02019108|Primary|Change From Baseline to Week 17 and From Baseline to Week 21 in Knee Joint Loading: First Peak Knee Adduction Moment|"Participants will undergo a gait analysis, where 10-15 trials of walking will be collected. Participants will walk in bare feet and at their own, self-selected speed while analyzed using three-dimensional motion analysis. Kinematic (joint angle) and kinetic (joint loading) data will be collected synchronously using high-speed digital cameras and floor-mounted force platforms. A total of 5 acceptable (clean force platform strikes and no observable deviation in walking characteristics) will be analyzed."|Weeks 0, 17, 21|Participants lost to follow-up. Gait modification group lost 3 participants by week 17 and 2 additional participants by week 21 making a total loss of 5. Walking Only group lost 6 participants by week 17 and 2 additional participants by week 21 making a total loss of 8.|||%Body Weight*Height||95% Confidence Interval|Least Squares Mean
2613642|NCT02019108|Primary|Change From Baseline to Week 17 and From Baseline to Week 21 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale.|Lower-limb impairments will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The WOMAC is a 24-item self-report questionnaire that quantifies pain (5 items), stiffness (2 items), and physical function (17 items). It is a valid, reliable, and responsive disease-specific self-report instrument and has been used in many knee OA studies. Minimum value of the WOMAC pain subscale is 0 and maximum value is 20. Higher scores mean a worse outcome.|Weeks 0, 17, 21|Participants lost to follow-up. Gait modification group lost 2 participants by week 17 and 3 additional participants by week 21 making a total loss of 5. Walking Only group lost 3 participants by week 17 and 4 additional participants by week 21 making a total loss of 7.|||units on a scale||95% Confidence Interval|Least Squares Mean
2613643|NCT02019108|Primary|Change From Baseline to Week 17 and From Baseline to Week 21 in Pain as Measured by Numerical Rating Scale|Average pain over the previous week will be assessed using an 11-point numerical rating scale (0 = no pain; 10 = maximum pain). Higher scores mean a worse outcome. Change was calculated as the value at 17 weeks and at 21 weeks minus the value at baseline.|Weeks 0, 17, 21|Participants lost to follow-up. Gait modification group lost 2 participants by week 17 and 3 additional participants by week 21 making a total loss of 5. Walking Only group lost 3 participants by week 17 and 4 additional participants by week 21 making a total loss of 7.|||units on a scale||95% Confidence Interval|Least Squares Mean
2613644|NCT02019069|Secondary|Serious Adverse Events|Serious adverse events were assessed as serious adverse events per 21CFR§312.32 that were Grade 3 or greater, and independent of relationship to CPX-351. The outcome is reported as the total number of the defined SAEs, a number without dispersion.|Up to 4 weeks after completion of treatment|Per protocol, the outcome only includes SAEs that are Grade 3 or greater. Adverse events that were Grade 2 or less, (eg, Grade 2 event with hospitalization) are not included.|||Adverse events|||Number
2613645|NCT02019069|Secondary|Participants Experiencing of Serious Adverse Events|Serious adverse events per participant were assessed as serious adverse events per 21CFR§312.32 that were Grade 3 or greater, and independent of relationship to CPX-351. The outcome is reported as the number of participants that experienced any defined SAE, a number without dispersion.|Up to 4 weeks after completion of treatment||||Participants|||Count of Participants
2613646|NCT02019069|Secondary|Mortality at Day 60 After 1st Induction|Mortality at Day 60 after 1st induction was assessed as the number of participants who died within 60 days of completing the 1st cycle of CPX-351 (1st induction). The outcome is reported as the number of participants without dispersion.|60 days||||Participants|||Count of Participants
2613647|NCT02019069|Secondary|Early Induction Mortality (Day 30 After 1st Induction)|Early induction mortality was assessed as the number of participants who died within 30 days of completing the 1st cycle of CPX-351 (1st induction). The outcome is reported as the number of participants without dispersion.|30 days||||Participants|||Count of Participants
2613648|NCT02019069|Secondary|Overall Survival (OS)|Overall survival (OS) was assessed as the number of participants remaining alive 12 months, starting from date of entry into trial. The outcome is reported as the number of participants (without dispersion).|At 12 months||||Participants|||Count of Participants
2613649|NCT02019069|Secondary|Duration of Remission (DOR) Following Induction With CPX-351|"Duration of remission (DOR) was assessed as the length of time from documented complete response (CR) or complete response with incomplete count recovery (CRi) until documented lost of response, relapse, or death. The outcome is reported as the median with full range.~CR = less than 5% blasts; no blasts with auer rods; and no persistence of extramedullary disease, with blood count recovery to platelets ≥ 100,000/uL and ANC > 1000/uL, with transfusion independence.~CRi = all the parameters for CR, but platelets < 100,000/uL and/or ANC ≤ 1000/uL.~For patients remaining alive, duration of remission (DOR) is reported as the length of time from documented complete response (CR) or complete response with incomplete count recovery (CRi) until the most recent assessment."|Up to 1 year||||days||Full Range|Median
2613650|NCT02019069|Secondary|Complete Response (CR)|"Complete response (CR) was determined the number of participants who achieved CR by Day 42 after induction treatment. The outcome is reported as the total number of participants without dispersion.~• CR = less than 5% blasts; no blasts with auer rods; and no persistence of extramedullary disease, with blood count recovery to platelets ≥ 100,000/uL and ANC > 1000/uL, with transfusion independence."|Day 42||||Participants|||Count of Participants
2613651|NCT02019069|Secondary|Complete Response With Incomplete Count Recovery (CRi)|"Complete response (CR) with incomplete count recovery (CRi) was determined as the number of participants who achieved CRi after induction therapy. The outcome is reported as the total number or participants without dispersion.~CR = less than 5% blasts; no blasts with auer rods; and no persistence of extramedullary disease, with blood count recovery to platelets ≥ 100,000/uL and ANC > 1000/uL, with transfusion independence.~CRi = all the parameters for CR, but platelets < 100,000/uL and/or ANC ≤ 1000/uL."|Day 42||||Participants|||Count of Participants
2613652|NCT02019069|Primary|Response Rate (RR)|"The response rate was determined as the sum of complete response calculated by adding the total complete response (CR) and complete response with incomplete count recovery (CRi). The outcome is reported as the total number without dispersion.~CR = less than 5% blasts; no blasts with auer rods; and no persistence of extramedullary disease, with blood count recovery to platelets ≥ 100,000/uL and ANC > 1000/uL, with transfusion independence.~CRi = all the parameters for CR, but platelets < 100,000/uL and/or ANC ≤ 1000/uL."|Day 42||||Participants|||Count of Participants
2613653|NCT02018887|Secondary|PK: CSF AUC(Tau) of Prodrug LY2969822 and Active Metabolite LSN2934747|AUC(tau) is 12 hours.|Cohort 8: Day 14 - 0 H, 0.5 H,1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H|CSF samples were only collected in Cohort 8. All participants in Cohort 8 who received at least one dose of LY2969822 and had evaluable CSF values on Day 14.|||nmol∙h/L||Geometric Coefficient of Variation|Geometric Mean
2613654|NCT02018887|Secondary|PK: Area Under the Drug Plasma Concentration Time Curve (Plasma AUC) of Prodrug LY2969822 and Active Metabolite LSN2934747|For Cohorts 1-2, AUC is extrapolated from time zero to infinity (AUC[0-inf]). For Cohorts 3 - 8, AUC is reported during one dosing interval (AUC[tau]). AUC(tau) is 24 hours for Cohorts 3 - 5 and 12 hours for Cohorts 6 - 8.|All Cohorts: Day 1 - 0 Hours (H), 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohort 3: Day 10 - 0 H, 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohorts 3 - 8: Day 14 - 0 H, 0.5 H,1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H|All participants who received at least one dose of LY2969822 and had evaluable plasma values.|||nanomoles x hours per liter (nmol∙h/L)||Geometric Coefficient of Variation|Geometric Mean
2613655|NCT02018887|Secondary|PK: Maximum Cerebrospinal Fluid Concentrations (CSF Cmax) of Prodrug LY2969822 and Active Metabolite LSN2934747|PK: Maximum Cerebrospinal Fluid Concentrations (CSF Cmax) of Prodrug LY2969822 and Active Metabolite LSN2934747|Cohort 8: Day 14 - 0 H, 0.5 H,1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H|CSF samples were only collected in Cohort 8. All participants in Cohort 8 who received at least one dose of LY2969822 and had evaluable CSF values on Day 14.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2613656|NCT02018887|Secondary|Pharmacokinetics (PK): Maximum Plasma Concentration (Plasma Cmax) of Prodrug LY2969822 and Active Metabolite LSN2934747|Pharmacokinetics (PK): Maximum Plasma Concentration (Plasma Cmax) of Prodrug LY2969822 and Active Metabolite LSN2934747|All Cohorts: Day 1 - 0 Hours (H), 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohort 3: Day 10 - 0 H, 0.5 H, 1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H; Cohorts 3 - 8: Day 14 - 0 H, 0.5 H,1 H, 2 H, 3 H, 4 H, 6 H, 9 H, 12 H, 16 H|All participants who received at least one dose of LY2969822 and had evaluable plasma values.|||nanomoles per liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2613657|NCT02018887|Primary|Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration|A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline Through End of Study (up to Week 7)|All participants who received at least one dose of study drug.|||participants|||Number
2613658|NCT02018822|Primary|Percent of Teeth With Polish-ability of A, B1 or B2|A= Smooth & highly shiny, similar to enamel B1= Smooth & satin, highly reflective B2= Smooth & shiny but not highly reflective|24 months|Participants with available data at 24 months. Two participants who received both the UDMA and TPH3 interventions were unevaluable for the TPH3 intervention at this time point.|||teeth|teeth||Count of Units
2613659|NCT02018822|Primary|Percent of Teeth With Proximal Contact|A= Tight proximal contacts evaluated with dental floss. B= Proximal contacts are weak but present. C= No proximal contacts but not visibly open. NA= Class I restorations|24 months|Participants with available data at 24 months. Two participants who received both the UDMA and TPH3 interventions were unevaluable for the TPH3 intervention at this time point.|||teeth|teeth||Count of Units
2613660|NCT02018822|Primary|Percent of Teeth With Marginal Discoloration of A or B|"A= There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color the adjacent tooth structure.~B= There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction."|24 months|Participants with available data at 24 months. Two participants who received both the UDMA and TPH3 interventions were unevaluable for the TPH3 intervention at this time point.|||teeth|teeth||Count of Units
2613661|NCT02018822|Primary|Percent of Teeth With Marginal Integrity Graded A, B1 and B2|A= No visible evidence of a crevice along the margin into which the explorer will penetrate B1= Explorer clicks on the margin B2= Visible evidence of a crevice|24 months|Participants with available data at 24 months. Two participants who received both the UDMA and TPH3 interventions were unevaluable for the TPH3 intervention at this time point.|||teeth|teeth||Count of Units
2613662|NCT02018822|Primary|Percent of Teeth Scored as A or B for Color Match|"A=The restoration appears to match the shade and translucency of adjacent tooth structure.~B=The restoration does not match the shade and translucency of adjacent tooth structure, but the mismatch is within the normal range of tooth shades and translucency."|24 months|Participants with available data at 24 months. Two participants who received both the UDMA and TPH3 interventions were unevaluable for the TPH3 intervention at this time point.|||teeth|teeth||Count of Units
2613663|NCT02018822|Primary|Percent of Teeth With Anatomic Form Graded as A or B.|"Anatomic form was graded as:~A=The restoration is continuous with existing form. B=The restoration is discontinuous with existing anatomic form, but the existing material is not sufficient to expose dentine."|24 months|Participants with available data at 24 months. Two participants who received both the UDMA and TPH3 interventions were unevaluable for the TPH3 intervention at this time point.|||teeth|teeth||Count of Units
2613664|NCT02018809|Secondary|Morisky Medication Adherence Scale (MMAS)|"The secondary outcome will be subjects' self-reports medication adherence. Morisky et al. developed this 8-item MMAS (MMAS-8) in 2008. The first seven items are Yes/No responses while the last item is a 5-point Likert response. The scoring scheme is: Yes = 0 and No = 1 (and 0 = 0 and 1-4 = 1 for Likert question). The items are summed to give a range of scores from 0 to 8. Respondents' summed score get grouped as follows: 0 = High Adherence; 1-2 = Medium Adherence; 3-8 = Low Adherence."|90 days||||units on a scale||Inter-Quartile Range|Median
2613665|NCT02018809|Primary|Statin Adherence|The primary outcome will be the percent of statin doses taken during the study as measured by the GlowCaps.|90 days||||percentage of correct statin doses||Standard Deviation|Mean
2613666|NCT02018653|Primary|Time to Resolution of Diarrhea (TTRD)|The primary endpoint is time to resolution of diarrhea (TTRD) defined as the time of the bowel movement that is not followed by another bowel movement within 8 hours. Participants will be evaluated for the primary endpoint for up to 6 days.|6 days|Too few subjects enrolled to make any conclusions.|||hours|||Number
2613667|NCT02018627|Secondary|Dermal Response (Draize Scale Grade for Edema Formation)|Average grade on the edema formation portion of the Draize scale for dermal response (0 being the lowest, 4 being the highest)|within 1 hour of injection|13 subjects completed the study following a consistent protocol using the glucagon doses described in the arm/group description. 7 subjects were randomized to get Xeris glucagon first, 6 subjects were randomized to get Lilly glucagon first. All 13 subjects received both glucagon injections, and the data is reported for each drug.|||score on draize scale||Standard Deviation|Mean
2613668|NCT02018627|Secondary|Dermal Response (Draize Scale for Erythema and Eschar Formation)|Average grade on the erythema and eschar formation portion of the Draize scale for dermal response (0 being the lowest, 4 being the highest)|within 1 hour of injection|13 subjects completed the study following a consistent protocol using the glucagon doses described in the arm/group description. 7 subjects were randomized to get Xeris glucagon first, 6 subjects were randomized to get Lilly glucagon first. All 13 subjects received both glucagon injections, and the data is reported for each drug.|||score on draize scale||Standard Deviation|Mean
2613669|NCT02018627|Secondary|Maximal Nausea|"Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly:~-Maximal nausea within 1 hour of injection on a 10 cm VAS: no nausea = 0, vomiting = 10"|within 1 hour of injection|13 subjects completed the study following a consistent protocol using the glucagon doses described in the arm/group description. 7 subjects were randomized to get Xeris glucagon first, 6 subjects were randomized to get Lilly glucagon first. All 13 subjects received both glucagon injections, and the data is reported for each drug.|||cm|||Number
2613670|NCT02018627|Secondary|Injection Site Erythema|"Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly:~-Injection site erythema or other local reaction, maximum diameter within 1 hour of injection"|within 1 hour of injection|13 subjects completed the study following a consistent protocol using the glucagon doses described in the arm/group description. 7 subjects were randomized to get Xeris glucagon first, 6 subjects were randomized to get Lilly glucagon first. All 13 subjects received both glucagon injections, and the data is reported for each drug.|||cm||Standard Deviation|Mean
2613671|NCT02018627|Secondary|Injection Pain|"Quantitation of adverse events related to glucagon injection for Xeris vs. Lilly:~-average Injection pain on a 10 cm standard VAS: 0 = no pain, 10 = worst imaginable pain reported immediately after injection of glucagon"|immediately after injection|13 subjects completed the study following a consistent protocol using the glucagon doses described in the arm/group description. 7 subjects were randomized to get Xeris glucagon first, 6 subjects were randomized to get Lilly glucagon first. All 13 subjects received both glucagon injections, and the data is reported for each drug.|||cm||Standard Deviation|Mean
2613672|NCT02018627|Secondary|t½Max|Glucagon t½max for Xeris vs. Lilly (non-inferiority)|every 2 minutes for 1 hour post-dose of each glucagon|13 subjects completed the study following a consistent protocol using the glucagon doses described in the arm/group description. 7 subjects were randomized to get Xeris glucagon first, 6 subjects were randomized to get Lilly glucagon first. All 13 subjects received both glucagon injections, and the data is reported for each drug.|||minutes||Standard Deviation|Mean
2613673|NCT02018627|Secondary|GIRmin|Minimal glucose infusion rate (GIRmin) for Xeris vs. Lilly (non-inferiority)|every 2 minutes for 1 hour post-dose of each glucagon|13 subjects completed the study following a consistent protocol using the glucagon doses described in the arm/group description. 7 subjects were randomized to get Xeris glucagon first, 6 subjects were randomized to get Lilly glucagon first. All 13 subjects received both glucagon injections, and the data is reported for each drug.|||dextrose mg/kg/min||Standard Deviation|Mean
2613674|NCT02018627|Secondary|AOCGIR|Area over the curve for glucose infusion rate in the hour following administration (AOCGIR) for Xeris vs. Lilly (non-inferiority)|every 2 minutes for 1 hour post-dose of each glucagon|13 subjects completed the study following a consistent protocol using the glucagon doses described in the arm/group description. 7 subjects were randomized to get Xeris glucagon first, 6 subjects were randomized to get Lilly glucagon first. All 13 subjects received both glucagon injections, and the data is reported for each drug.|||mg*min/kg||Standard Deviation|Mean
2613675|NCT02018627|Primary|Tmax|tmax for Xeris vs. Lilly (non-inferiority)|every 2 minutes for 1 hour post-dose of each glucagon|13 subjects completed the study following a consistent protocol using the glucagon doses described in the arm/group description. 7 subjects were randomized to get Xeris glucagon first, 6 subjects were randomized to get Lilly glucagon first. All 13 subjects received both glucagon injections, and the data is reported for each drug.|||minutes||Standard Deviation|Mean
2613679|NCT02018562|Secondary|Level of Independence With Talking Tracheostomy Tube|Participants were asked how independently they thought they could use the tracheostomy tube. Will report the number of participants who indicated some level of independence.|2 weeks|This outcome was assessed for all 22 participants who completed the intervention arm. No data was collected for any of the participants in control arm.|||Participants|||Count of Participants
2613680|NCT02018562|Secondary|Speech Intelligibility|The Speech Intelligibility Test has 11 randomly computer generated sentences that patients are asked to read aloud. They are recorded and judged by an unfamiliar listener at a later time. Scores range from 0 - 100 with higher scores indicating greater level of speech intelligibility.|2 weeks|Only 18 participants in the intervention group were assessed because only 18 of them were able to read the sentences. No data was collected from any participants in the control group for this outcome measure.|||percentage of intelligible sentences||Standard Deviation|Mean
2613681|NCT02018562|Primary|Change in Quality of Life|Voice-Related Quality of Life (V-RQOL). It is a 10-item scale with each items 2 - 10 and total score ranges from 20 - 100. Lower scores refers to higher quality of life and Higher scores refer to lower level quality of life.|Baseline; 2 weeks post BLUSA|Change could only be assessed for 22 participants because 3 participants in the intervention arm dropped out prior to the post assessment.|||units on a scale||Standard Deviation|Mean
2613682|NCT02018562|Primary|Change in Quality of Life|Quality of Life in Mechanically Ventilated Patients Questionnaire (QOL-MV) was used to measure quality of life. It is a 12-item scale with each items 0 - 10 and total score ranges from 0 - 120. Lower scores refers to lower quality of life and Higher scores refer to higher level quality of life. To be assessed at baseline and 2 weeks post Portex Blueline Ultra Suctionaid (BLUSA).|Baseline; 2 weeks post BLUSA|Change could only be assessed for 22 participants because 3 participants in the intervention arm dropped out prior to the post assessment.|||units on a scale||Standard Deviation|Mean
2613683|NCT02018458|Secondary|Disease Free Survival With DC Vaccine|Analysis of disease free survival in both groups will be done using standard & established statistical methods.|4 year||||Participants|||Count of Participants
2613684|NCT02018458|Secondary|Pathologic Complete Response Rate With and Without Anakinra|Patients will undergo surgical resection of residual breast and axillary malignant tissue after protocol-directed treatment. The pathologic specimen will be graded according to the tumor regression grading schema called the Residual Cancer Burden (RCB).|4 year|All participants who received at least one dose of treatment.|||Participants|||Count of Participants
2613685|NCT02018458|Primary|Safety of DC Vaccine Combined With Chemotherapy, and DC Vaccine Combined With Chemotherapy|Toxicities in both groups will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 . Includes all patients (eligible and ineligible) who receive at least 1 inoculation of DC vaccine therapy. This safety population will also be used for the summaries and analysis of all safety parameters (drug exposure, tables of adverse events information, including serious adverse events, etc.).|4 years||||Participants|||Count of Participants
2613686|NCT02018445|Secondary|Number of Patients With Serious Adverse Events, Adverse Device Effects, Serious Adverse Device Effects and Subsequent Surgical Interventions||24 months||||Participants|||Count of Participants
2613687|NCT02018445|Secondary|Medical Outcomes: Maintenance of Lower Extremity Neurological Function|"Posterolateral fusion study in which one spinal level is treated with both the study and control arm. One posterolateral spinal side is Evo3 and the other posterolateral spinal side is local autograft.~NA (Not Applicable): Neurological function data was not able to be analyzed as there was a limitation of the method in the ability to distinguish between left and right side neurological function. Neurological function is indistinguishable between the right and left side of the lower extremities using the methods in the protocol and analysis of neurological function therefore would have made no impact on the outcome of the study."|12 months|NA (Not Applicable): Neurological function data was not able to be analyzed as there was a limitation of the method in the ability to distinguish between left and right side neurological function. Neurological function is indistinguishable between the right and left side of the lower extremities using the methods in the protocol.||||||
2613688|NCT02018445|Secondary|Medical Outcomes: Measure of EQ-5D™ Visual Analog Scale (VAS).|EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The EQ-5D-5l has a descriptive system and the EQ visual analogue scale (EQ VAS). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. Only the EQ VAS Score was analyzed in the study. The EQ VAS scored from 0-100 and a lower score represents a better score.|12 months|Patients were loss to follow-up as clinical study progressed.|||units on a scale||Standard Deviation|Mean
2613689|NCT02018445|Secondary|Medical Outcomes: Back Pain Visual Analog Scale (VAS)|"The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100- mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of 0/no pain at all and 100/worst pain imaginable. The study in this scale is used for the back pain. A lower score represents a better score."|12 months|Patients were lost to follow-up as study progressed|||units on a scale||Standard Deviation|Mean
2613690|NCT02018445|Secondary|Medical Outcomes: Worst Leg Pain Visual Analog Scale (VAS)|"The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of 0/no pain at all and 100/worst pain imaginable. The study in this scale is used for the worst leg pain. A lower score represents a better score."|12 months|Patients lost to follow-up over course of the study.|||units on a scale||Standard Deviation|Mean
2613691|NCT02018445|Secondary|Medical Outcomes: Oswestry Disability Index (ODI)|The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by surgeons, clinicians and researchers to quantify disability for low back pain. The questionnaire is self-completed and covers 10 topics about pain intensity, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Scores are from 0-100 and a lower score represents a better score.|12 months|Patients were lost to follow-up as study progressed|||units on a scale||Standard Deviation|Mean
2613692|NCT02018445|Secondary|Percent (%) of Fusion for Each Spinal Level (Unit), as Measured by Computed Tomography (CT) Scan||12 months||||Posterolateral Sides|Posterolateral Sides||Count of Units
2613693|NCT02018445|Primary|Time to Arthrodesis (Fusion) for Each Spinal Level (Unit), as Measured by X-rays.|There were 29 patients and 43 total spinal levels (unit) treated at baseline. Time to arthodesis was measured as the mean time to achieve fusion. At each time point fusion was evaluated, the first time point fusion was achieved was considered fusion.|12 months|Time to arthodesis was measured as the mean time to achieve fusion for each spinal level treated.|||months to fusion|Spinal Levels|Standard Deviation|Mean
2613694|NCT02018315|Secondary|Number of Participants With Change in Brain Metabolic Rate After 3 Months|Magnetic Resonance Imaging (MRI) used to calculate brain metabolic rate. Brain metabolic rate compared before oil ingestion (Baseline), 90 minutes after oil ingestion, and after 3 months of daily oil ingestion in each participant. Triheptanoin metabolism may lead to increased oxygen consumption only while the brain undergoes a reduction of ictogenesis. We hypothesize that when ictogenesis is abolished by triheptanoin or absent at baseline, triheptanoin exerts little or no effect on CMR02.|3 months|5 participants out of the 14 total participants enrolled completed the optional MRI . Reasons for participants electing to not participate in imaging included inability to remain immobile due to movement disorder or anxiety, immaturity, metal implants, and personal choice.|||Participants|||Count of Participants
2613695|NCT02018315|Primary|Number of Participants With Reduction in Spike-wave Fraction of the EEG Recording Time|Visual analysis of EEG recording to determine the fraction of spike-range within the area of recording.|1 day||||Participants|||Count of Participants
2613696|NCT02018107|Secondary|Does an Inadequate Ablation Margin on PET Predict Local Progression? Compare to MRI?|Percentage of tumors with an inadequate margin on PET that progressed locally? Compare to MRI?|2 Years||||percentage of tumors|Tumors||Number
2613697|NCT02018107|Primary|Number and Percentage of Tumors With Complete, Circumferential Ablation Margin Visibility During FDG PET/CT-guided Liver Ablations (AP-PET-1 v. Contrast-enhanced MRI)|For FDG-avid tumors, compare the rates of complete, circumferential ablation margin visibility during FDG PET/CT-guided liver ablations using two imaging techniques: intra-procedural AP-PET-1(research scan #1) and post-procedural contrast enhanced MRI . Discordance rates for complete ablation margin visibility between the two imaging techniques will be calculated.|2 Years|In this study, the number of tumors were analysed. There 8 participants with 11 tumors that were analysed for N-13 ammonia to image liver PET perfusion and 31 tumors in 20 patients were analysed in F-18 fluorodeoxyglucose to image liver PET perfusion. 1 participant participated in both interventions. Total unique participants 27.|||Tumors|Tumors||Count of Units
2613698|NCT02018042|Secondary|Measurement of Quality of Life|Quality of life measures were based on changes in the Dermatology Life Quality Index (DLQI). The DLQi is a 10-item questionnaire with each question scored from 0 (not at all) to 3 (very much). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0 (better outcome). The higher the score, the more quality of life is impaired.|Baseline, Week 12, Week 24||||score on a scale||Standard Deviation|Mean
2613699|NCT02018042|Secondary|Percentage of Hair Regrowth|Percent hair regrowth from baseline determined by global overall improvement in SALT measurements following 24 weeks of treatment.|Week 24||||percentage||Full Range|Mean
2613700|NCT02018042|Primary|Total Number of Participants With At Least 50% Hair Regrowth|The study's primary efficacy endpoint will be the proportion of responders after 6 months of treatment, with response defined as 50% or greater hair re-growth from baseline as assessed by Severity of Alopecia Tool (SALT) score at week 24. This is a relatively strict definition for defining responders and non-responders and was chosen to minimize the potential for spontaneous remission, in which fewer than 10% are expected to achieve this magnitude of hair regrowth spontaneously.|Week 24||||Participants|||Count of Participants
2613701|NCT02017964|Other Pre-specified|Change in Neurocognitive and Adaptive Functioning Assessed Using Full Scale IQ Score (FSIQ) and General Adaptive Composite Score (GAC)|Changes will be described via paired tests and confidence intervals both for FSIQ and GAC in order to capture any deterioration over time.|Baseline to up to 60 months|||||||
2613702|NCT02017964|Other Pre-specified|Molecular Profile|Contingency table analysis will be used to examine the association of molecular profile with histology.|Up to 2 years|||||||
2613703|NCT02017964|Other Pre-specified|Feasibility of Rapid Central Pathology Screening Review Defined as Success Rate of Timely Central Pathology Review Based on the Expectation That at Least 95% of the Cases Will be Reviewed Within 10 Days|At the end of the trial the feasibility of such a prescreening process will be assessed by reporting the percentage and the associated confidence interval of cases where the central review was obtained within 10 days from receipt of slides.|Up to 10 days|||||||
2613704|NCT02017964|Primary|Percentage of Patients With Responses at 273 Days|The percentage of patients with complete response (CR) at the end of therapy (~273 days) was reported and presented with the associated exact 95% confidence interval.|273 days from start of treatment|26 patients were enrolled on the protocol, but 1 was deemed ineligible. The ineligible patient is excluded from all analyses.|||Percentage of patients||95% Confidence Interval|Number
2613705|NCT02017964|Primary|Percentage of Patients With Responses at 189 Days|The percentage of patients with complete response (CR) at the end of induction (~189 days) was reported and presented with the associated exact 95% confidence interval.|189 days from start of treatment|26 patients were enrolled on the protocol, but 1 was deemed ineligible. The ineligible patient was excluded from all analyses.|||Percentage of patients||95% Confidence Interval|Number
2613706|NCT02017964|Primary|Event-free Survival (EFS)|Event-free survival (EFS) is defined as the time from diagnosis to the earliest of disease progression/recurrence, second malignancy or death from any cause, or to the date of last follow-up for patients without events. EFS was estimated using the method of Kaplan and Meier. 2-year estimates are reported with 95% CI's.|2 years from diagnosis|26 patients were enrolled on the protocol, but 1 was deemed ineligible. The ineligible patient is excluded from all analyses.|||percent probability||95% Confidence Interval|Number
2613707|NCT02017964|Primary|Overall Survival (OS)|Overall Survival (OS) is defined as the time from diagnosis to death from any cause, or to the date of last follow-up for survivors. OS was estimated using the method of Kaplan and Meier. 2-year estimates are reported with 95% CI's, as the data are not mature to 72 months.|Assessed up to 72 months, reported at 2 years from diagnosis|26 patients were enrolled on the protocol, but 1 was deemed ineligible. The ineligible patient was excluded from all analyses.|||percent probability||95% Confidence Interval|Number
2613708|NCT02017964|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined as the time interval from diagnosis to the earliest of disease progression/recurrence or death from any cause, or to the date of last follow-up for patients without events. PFS was estimated using the method of Kaplan and Meier. 2-year estimates are reported with 95% CI's.|2 years from diagnosis|26 patients were enrolled on the protocol, but 1 was deemed ineligible. The ineligible patient was excluded from all analyses.|||percent probability||95% Confidence Interval|Number
2613709|NCT02017899|Secondary|Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU)|High seroresponse is defined as a post vaccination titer ≥X anti-LPS serum IgG units in the GSK (former Novartis) ELISA that correspond to a titer of 1:800 in the ELISA method used by Cohen et al. To determine the value for 'X' the GSK (former Novartis) anti-LPS ELISA was calibrated against the Cohen ELISA and it was found that a concentration of 121 EU EU/mL corresponds to a titer of 1:800 in the Cohen assay|At baseline, at 28 days after each vaccination and at 168 days after last vaccination|Analysis was done on the Full Analysis Set (FAS), ie, subjects in All Enrolled Set who: received a study vaccination, provided evaluable serum, with results available & who was not excluded due to protocol deviations or other reasons defined before unblinding or analysis|||Participants|||Count of Participants
2613710|NCT02017899|Secondary|Number of Subjects With Seroresponse for Anti-LPS S. Sonnei|Seroresponse is defined as: If half of the baseline value is greater than 25 ELISA Unit (EU) then an increase of at least 50% in the post-vaccination sample as compared to baseline [i.e. ((Post-vac minus baseline)/baseline)100% ≥ 50%]. If half of the baseline value is less or equal to 25 EU then an increase of at least 25 EU in the post-vaccination sample as compared to baseline (i.e. [post-vac minus baseline] ≥25 EU)|At 28 days after each vaccination and 168 days after last vaccination|Analysis was done on the Full Analysis Set (FAS), ie, subjects in All Enrolled Set who: received a study vaccination, provided evaluable serum, with results available & who was not excluded due to protocol deviations or other reasons defined before unblinding or analysis|||Participants|||Count of Participants
2613711|NCT02017899|Secondary|Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs)||At baseline, at 28 days after each vaccination and at 168 days after last vaccination|Analysis was done on the Full Analysis Set (FAS), ie, subjects in All Enrolled Set who: received a study vaccination, provided evaluable serum, with results available & who was not excluded due to protocol deviations or other reasons defined before unblinding or analysis|||Titers||95% Confidence Interval|Geometric Mean
2613712|NCT02017899|Primary|Number of Subjects With Neutrophils Results Below and Above the Normal|Day 225: VISIT 6 (6 months post 3rd vac.)|At Day 225||||Participants|||Count of Participants
2613713|NCT02017899|Primary|Number of Subjects With Neutrophils Results Below and Above the Normal|Day 85: VISIT 5 (1 month post 3rd vac.)|At Day 85||||Participants|||Count of Participants
2613714|NCT02017899|Primary|Number of Subjects With Neutrophils Results Below and Above the Normal|Day 64: VISIT 4.1 (D7 post 3rd vac.)|At Day 64|Some arms have zero subjects attending visit 3.1, as complete blood counts testing 7 days after 2nd and 3rd vaccination was introduced following a protocol amendment while the study was ongoing.|||Participants|||Count of Participants
2613715|NCT02017899|Primary|Number of Subjects With Neutrophils Results Below and Above the Normal|Day 57: VISIT 4 (3rd vac.)|At Day 57||||Participants|||Count of Participants
2613716|NCT02017899|Primary|Number of Subjects With Neutrophils Results Below and Above the Normal|Day 36: VISIT 3.1 (D7 post 2nd vac.)|At Day 36|Some Arms have zero subjects attending visit 3.1, as complete blood counts testing 7 days after 2nd and 3rd vaccination was introduced following a protocol amendment while the study was ongoing.|||Participants|||Count of Participants
2613717|NCT02017899|Primary|Number of Subjects With Neutrophils Results Below and Above the Normal Ranges|Day 8: VISIT 2 (D7 post 1st vac)|At Day 8||||Participants|||Count of Participants
2613718|NCT02017899|Primary|Number of Subjects With Solicited Systemic Reaction After Any Vaccination|Any= Incidence of any symptom regardless of intensity grade. Grade 3 = symptom that prevented daily activities|During a 7-day (Days 1 to 7) post vaccination period following any injection|Analysis was done on as treated population|||Participants|||Count of Participants
2613719|NCT02017899|Primary|Number of Subjects With Solicited Local Reaction After Any Vaccination|Any erythema/induration refers to: ≥25 mm in diameter. Grade 3 (severe) refers to erythema/induration >100 mm in diameter. Grade 3 (severe) for injection site pain refers to: prevents daily activity|During a 7-day (Days 1-7) post vaccination period following any injection|Analysis was done on as treated safety population|||Participants|||Count of Participants
2613720|NCT02017860|Primary|Number of Pariticipants With Adverse Events as a Measure of Safety and Tolerability|Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.|Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approximately 5 years.|Safety Set-included all subjects who received at least one dose (partial or complete) of everolimus, and had at least one valid post-baseline safety assessment. The statement that a subject had no AEs (on the AEs eCRF) constituted a valid safety assessment.|||Count of Participants|||Number
2613721|NCT02017574|Secondary|EEG Derived High Alpha Power|Brain electrophysiology measure of attentional processes as indexed by high alpha power (10-13 Hz). The unit of measurement is a percentage as the amount of power (microvolts squared) in the high alpha band was divided by the total power in the spectrum (i.e. 1-50 Hz). This method is commonly employed to normalize the power of a particular frequency if the statistical design includes a between subjects factor.|2 Years|Of the 24 participants recruited , 4 were excluded from the analysis due to poor data quality.|||percentage of the total power||Standard Error|Mean
2613722|NCT02017574|Primary|Quality of Motor Performance|Quality of motor behavior was indexed by the percentage of samples in which the participants were within the trained (i.e. optimal) trajectory. The trained trajectory was a 2cm wide channel in the shape of a half circle between two targets which were 25cm apart from each other. Therefore, the scale measure is a percentage which can range between 0 and 100%.|2 Years|Of the 24 participants recruited , 4 were excluded from the analysis due to poor data quality.|||percentage of samples not 'on' task||Standard Deviation|Mean
2613765|NCT02016885|Secondary|Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 4||Baseline - Week 4|Participant|||Participants|||Count of Participants
2613723|NCT02017535|Primary|Social Adjustment Scale - Self Report (SAS-SR)|The SAS-SR is a 42-item self report measure of role performance in the past 2 weeks. Items are rated on a 5-point scale. Total scores are calculated by summing the 42 item scores and dividing by the total number of items answered. Total scores range from 1 to 5, with higher scores indicating greater impairment of functioning.|16 weeks, 32 weeks||||score on a scale||Standard Deviation|Mean
2613724|NCT02017535|Primary|Beck Depression Inventory-II (BDI-II)|BDI-II is a 21-item self-report multiple-choice inventory that assesses the severity of depressive symptoms reflective of DSM-IV diagnostic criteria over the prior week. Items are rated on a 4-point scale ranging from 0 to 3. Total scores are a sum of the 21 item scores ranging from 0 to 63. Higher scores indicate more severe depression symptoms.|16 weeks, 32 weeks||||score on a scale||Standard Deviation|Mean
2613725|NCT02017535|Primary|Children's Global Assessment Scale (CGAS)|The CGAS is a numeric scale used by mental health clinicians to rate the general functioning of youths under the age of 18. Scores range from 1 to 100, with higher scores indicating better functioning.|16 weeks, 32 weeks||||score on a scale||Standard Deviation|Mean
2613726|NCT02017535|Primary|Children's Depression Rating Scale-Revised (CDRS-R)|The CDRS-R is a clinician-administered semi-structured interview designed to assess present episode and lifetime history of psychiatric diagnoses based on DSM-IV criteria. This survey contains 17 items; 3 items are rated on a scale from 0 to 5, 5 items are rated on a scale from 0 to 6, and the remaining 9 items are rated on a scale from 0 to 7. Total score is a raw sum of the 17 item scores and ranges from 0 to 108. Higher scores indicate greater depression severity.|16 weeks, 32 weeks||||score on a scale||Standard Deviation|Mean
2613727|NCT02017522|Secondary|The Ratio of 11C-PBR28 PET Activity in Cardiac Regions With Fibrosis|"As a secondary outcome of this study we will evaluate the ratio of 11C-PBR28 PET activity in regions with fibrosis indicated by decreased myocardial perfusion on 82Rb PET and/or late gadolinium enhancement on cardiac MRI without imaging signs of active inflammation compared to 11C-PBR28 PET activity in myocardial segments which appear normal on 82Rb PET, FDG PET and cardiac MRI. This outcome will thus be expressed by 11C-PBR28 PET uptake in fibrotic regions as a percentage of uptake in normal segments~We will also evaluate the concordance between extracardiac activity seen in 11C-PBR28 and FDG PET, and when available, histopathology of contemporaneous biopsy specimens."|1 hour scan|Because the two scans performed provided inadequate clarity to allow any analysis, the additional measurements anticipated as secondary were not feasible.||||||
2613728|NCT02017522|Primary|Ratio of 11C-PBR28 in the Myocardium|The primary outcome of this study will be the ratio of 11C-PBR28 PET activity in myocardial regions with inflammation indicated by FDG PET and/or edema indicated by increased T2 signal with cardiac MRI compared to the 11C-PBR28 PET activity in myocardial segments which appear normal on FDG PET and cardiac MRI. The primary outcome is thus the intensity of uptake in abnormal regions as a percentage of the intensity of uptake in normal segments.|1 hour scan|Insufficient myocardial tissue contrast to define abnormal and normal regions.||||||
2613729|NCT02017327|Primary|Safety With Respect to the Assessment of Conjunctival Hyperaemia in the Worse Eye|"The primary endpoint is the change from baseline of conjunctival hyperaemia assessed on MacMonnies' 6 point ordinal scale, in the worse eye at the D84 visit. The primary statistical hypothesis tested is that Monoprost® is superior to Lumigan® 0.03% Unit Dose with regard to this primary endpoint, i.e. that in the worse eye the decrease from baseline in the MacMonnies 6 point ordinal scale is greater in the Monoprost® treated group than in the Lumigan® 0.03% Unit Dose group at the Day 84 visit.~The conjunctival hyperaemia will be scored using the McMonnies photographic scale (0 to 5). The minimum score is 0 corresponding to a low hyperaemia and the maximum score is 5 corresponding to a higher hyperaemia.~The Rows represent the number of participants with a change from Baseline to D84 corresponding to~decrease of 3 points~decrease of 2 points~no change,~increase of 2 points~increase of 1 point on Mc Monnies scale"|Day 84|the primary analysis was performed in the mSAF.(All randomised patients of the Safety set with at least one eligible eye and with any safety information on treatment.)|||Participants|||Count of Participants
2613730|NCT02017223|Primary|Objectively Measured Physical Activity From Accelerometer and KNOWME Network|Participants will wear an accelerometer on the waist for 3 days to gather baseline data on habitual physical activity, and then wear KNOWME for one weekend, along with an accelerometer - no more than two weeks after baseline. Outcome is the difference between baseline and KNOWME wear (differences in moderate to vigorous physical activity and sedentary time).|Pretest for one weekend (Friday-Sunday) and during KNOWME wear for one weekend (Friday-Sunday||||minutes||Standard Deviation|Mean
2613731|NCT02017210|Secondary|Fasting Serum Insulin|"Change in fasting serum insulin was determined as Follow-up Value - Baseline Value /Time between measurements. There were 2 time points 6 years apart"|6 years|Fasting serum insulin measurement was available in a sub-cohort of n=16, 18 and 19 in normal weight, overweight/obese insulin-sensitive and overweight/obese insulin-resistant participants, respectively|||mU/L/year||Inter-Quartile Range|Median
2613732|NCT02017210|Secondary|Fasting Blood Glucose|"Change in fasting blood glucose was determined as Follow-up Value - Baseline Value /Time between measurements. There were 2 time points 6 years apart"|6 years|Fasting blood glucose concentration measure was available in a sub-cohort of n=16, 18 and 19 in normal weight, overweight/obese insulin-sensitive and overweight/obese insulin-resistant participants, respectively|||mmol/L/year||Inter-Quartile Range|Median
2613733|NCT02017210|Secondary|Diastolic Blood Pressure|"Change in Diastolic Blood Pressure was determined as Follow-up Value - Baseline Value /Time between measurements. There were 2 time points 6 years apart"|6 years|All individuals who were followed up after 6 years were analyzed|||mmHg/year||Inter-Quartile Range|Median
2613734|NCT02017210|Secondary|Systolic Blood Pressure|"Change in Systolic Blood Pressure was determined as Follow-up Value - Baseline Value /Time between measurements. There were 2 time points 6 years apart"|6 years|All individuals who were followed up after 6 years were analyzed|||mmHg/year||Inter-Quartile Range|Median
2613735|NCT02017210|Secondary|Visceral Fat Volume|"Abdominal visceral fat volume from DXA change was determined as Follow-up Value - Baseline Value /Time between measurements. There were 2 time points 6 years apart"|6 years|Visceral fat volume was available in n=11, 10 and 18 normal weight, overweight/obese insulin-sensitive and overweight/obese insulin-resistant participants who undergone a DXA measure due to technical reasons|||cm^3/year||Inter-Quartile Range|Median
2613737|NCT02017210|Secondary|Body Fat Mass|"Body fat mass from dual-energy X-ray absorptiometry (DXA) change was determined as Follow-up Value - Baseline Value /Time between measurements. There were 2 time points 6 years apart"|6 years|DXA was performed in a sub-cohort of n=11, 11 and 19 in normal weight, overweight/obese insulin-sensitive and overweight/obese insulin-resistant participants, respectively|||% of total body mass/year||Inter-Quartile Range|Median
2613738|NCT02017210|Secondary|Waist Circumference|"Change in waist circumference was determined as Follow-up Value - Baseline Value /Time between measurements. There were 2 time points 6 years apart"|6 years|All individuals who were followed up after 6 years were analyzed|||cm/year||Inter-Quartile Range|Median
2613739|NCT02017210|Secondary|Body Mass Index|"Change in body mass index (BMI) was determined as Follow-up Value - Baseline Value /Time between measurements. There were 2 time points 6 years apart"|6 years|All individuals who were followed up after 6 years were analyzed|||kg/m^2/year||Inter-Quartile Range|Median
2613740|NCT02017210|Primary|Insulin Sensitivity|"The change in insulin sensitivity (as measured by M-value normalised to insulin from hyperinsulinemic-euglycemic clamp) was determined Follow-up Value - Baseline Value /Time between measurements. There were 2 time points 6 years apart"|6 years|The hyperinsulinemic-euglycemic clamp was performed in a sub-cohort of n=9, 10 and 16 participants who were normal-weight, overweight/obese insulin-sensitive and overweight/obese insulin-resistant, respectively|||micro mol/min/Kg/mU/L/year||Inter-Quartile Range|Median
2613741|NCT02017093|Primary|Fugl-Meyer Assessment Score|The Fugl-Meyer assessment score (FM) is a zero (disabaled function) to 66 points (high level of function) scale that evaluates the level of the motor impairment of the upper extremity, in stroke patients.|The measured assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of the rehabilitation (T2).||||units on a scale||Standard Deviation|Mean
2613742|NCT02017093|Primary|Improvement in Average Movement Trajectory Error From T1 to T2|While reaching, people have typical movement pattern of trajectory, moving the end-effector (hand) in straight line. The abnormal motor control after a stroke may cause these patients to deviate from this pattern. Our robotic device enabled us to measure the magnitude of the deviation from the optimal profile of healthy people. This was followed by a calculation of the average error the paricipants made in each treatment session. So we finally recieved a score of the average magnitude of trajectory error the participants made through a treatment session. Each treatment seesoin composed of about 100 reaching movements. The outcome measure expresses the change in the movement error from T1 to T2.|The outcome was assessed at the begining of the rehabilitation (T1) and about 5 weeks later at the end of rehabilitation (T2).||||cm||Standard Deviation|Mean
2613743|NCT02017015|Secondary|Kaplan-Meier Estimate of Overall Survival (OS)|Overall survival was defined as the time from the date of first treatment to the date of death. Participants who did not die at the end of study or clinical data cut were censored on the last-known-to-be-alive date or the clinical cut-off date, whichever was earlier.|From the first participant enrolled to data cut off of 01 June 2015; up to approximately 70 weeks|ITT population includes all enrolled participants|||months||95% Confidence Interval|Median
2613744|NCT02017015|Secondary|Duration of Response (DoR) Based on IRR According to RECIST Guidelines|DoR was defined as the time from the first tumor assessment when the confirmed CR/PR response criterion is met to the date of disease progression based on IRR following RECIST 1.0. Only for those participants with a confirmed CR/PR. If a participant had disease progression, then the date of disease progression was the event date. For a participant who did not develop disease progression or disease progression occurred after 2 or more missing tumor assessments, the participant was censored on the date of last tumor assessment where the participant was documented to be progression free. If a participant died prior to disease progression, the participant was censored on the date of death. If patient started new anti-cancer therapy, the patient was censored on the last tumor assessment date on or prior to the start date of new anti-cancer therapy|Assessment performed every 8 weeks; from the first participant enrolled to cut off date of 01 June 2015; up to approximately 70 weeks|Includes participants with a Confirmed Complete or Partial Response|||months||95% Confidence Interval|Median
2613745|NCT02017015|Primary|Overall Response Rate (ORR) Based on Independent Radiological Review (IRR)|ORR was defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) based on independent radiological review per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (V1.0). Using RECIST Version 1.0, participants were to achieve either a complete response defined as the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation or partial response defined as at least a 30% decrease in the sum of the longest diameters of target lesions and no progression in non-target lesions based on confirmed responses from the independent radiological review of best overall response during study treatment.|Assessment every 8 weeks; Day 1 to data cut off of 01 June 2015; Up to approximately 70 weeks|Intent to Treat (ITT) population included all participants enrolled into the study|||percentage of participants||95% Confidence Interval|Number
2613746|NCT02017015|Secondary|Number of Participants Experiencing Treatment Emergent Adverse Events (TEAE)|TEAEs were defined as adverse events (AEs) that began or worsened in severity on or after the date of the first dose of study drug and within 30 days of the last dose of study drug. A Serious AE (SAE) = any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, is a congenital anomaly/birth defect; constitutes an important medical event. Treatment-related AEs (TRAEs) were any TEAEs considered to be related to the study drug. A TRAE is a TEAE with relationship as suspected to either ABI-007 or gemcitabine The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Other AEs not described in the CTCAE criteria, the intensity will be assessed by the investigator as mild grade (Gr 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5)|Study drug initiation through 30 days after the last dose of study drug or End Of Study, whichever is later; maximum treatment duration was 54.9 weeks|Safety population includes all enrolled participants who received at least 1 dose of study drug|||participants|||Number
2613767|NCT02016885|Primary|Percentage of Subjects Who Have a Minimum 2-grade Improvement in HDSS From Baseline at Week 4|"HDSS is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects' condition based on how it affects daily activities.~1 (Best), 2, 3, 4 (Worst)"|Baseline - Week 4|Participant|||Participants|||Count of Participants
2613747|NCT02016963|Secondary|Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose|Blood was collected from each participant at the selected times: pre-dose (Day 0), 0.00347 hours (Day 0), 0.3333 hours (Day 0), Day 1, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42, and Day 56 post-dose. Serum specimens were analyzed for raxibacumab using a validated electrochemiluminescense-based assay. The individual serum raxibacumab concentration data were summarized by nominal collection time and treatment group using descriptive statistics|From the date of the dose administration of study agent for this study (Day 0) until Day 56|As-treated population|||Micrograms/milliliter (µg/mL)||Standard Deviation|Mean
2613748|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities|Urinalysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
2613749|NCT02016963|Secondary|Number of Participants With Urinalysis Toxicities of the Indicated Grade|Urinaysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
2613750|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities|The number of participants with at least a 2-grade worsening from Baseline in other chemistry toxicities is presented. Other clinical chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
2613751|NCT02016963|Secondary|Number of Participants With Other Chemistry Toxicities of the Indicated Grade|Other chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
2613752|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities|The number of participants with at least a 2-grade worsening from Baseline in electrolyte toxicities is presented. Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0.Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
2613753|NCT02016963|Secondary|Number of Participants With Electrolyte Toxicities of the Indicated Grade|Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
2613766|NCT02016885|Primary|Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 4|Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject's axilla with the arm down by the subject's side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min.|Baseline - Week 4|Participant|||mg/5 min||Standard Deviation|Mean
2613754|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities|The number of participants with at least a 2-grade worsening from Baseline in liver toxicities is presented. Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
2613755|NCT02016963|Secondary|Number of Participants With Liver Toxicities of the Indicated Grade|Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
2613756|NCT02016963|Secondary|Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities|The number of participants with at least a 2-grade worsening from Baseline in hematological toxicities is presented. Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
2613757|NCT02016963|Secondary|Number of Participants With Hematological Toxicities of the Indicated Grade|Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
2613758|NCT02016963|Secondary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. This includes worsening (eg, increase in frequency or severity) of pre-existing conditions. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population|||Participants|||Number
2613759|NCT02016963|Primary|Number of Participants Who Developed a Positive Anti-raxibacumab Antibody Response|Number of participants who developed an positive anti-raxibacumab antibody response during the study were assessed.The antibody response to raxibacumab was assessed using a screening assay (i.e. by electrochemiluminescence counts). Positive samples would be further tested in an inhibition of binding assay to confirm the specificity of binding.|From the date of the dose administration of study agent for this study (Day 0) until Day 70|As-treated population : all participants who received 1 dose of study treatment.|||Participants|||Number
2613760|NCT02016898|Secondary|Change in Intraocular Pressure|To assess final intraocular pressure lowering between patients who receive mitomycin-C using a sponge versus irrigation|post-operative day 1 to month 6|Five participants in each group were not included due to being lost to follow-up or deceased.|||mmHg (millimeters of mercury)||Standard Deviation|Mean
2613761|NCT02016898|Primary|Complication Rates|To assess complication rates between patients who receive mitomycin-C using a sponge versus irrigation|post-operative day 1 to month 6||||Participants|||Count of Participants
2613762|NCT02016885|Secondary|Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 4|The DLQI is a ten question questionnaire, used to measure the impact of skin disease on the quality of life of an affected person. The scoring of each question is as follows: Very much (3), A lot (2), A little (1), Not at all (0), Not relevant (0). Is calculated by summing the score of each question resulting in a max of 30 and a min of 0. Higher the score the more Quality of life is impaired.|Baseline - Week 4|Participant|||scores on a scale||Standard Deviation|Mean
2613763|NCT02016885|Secondary|Percentage of Subjects Who Have a Minimum 1-grade Improvement in HDSS From Baseline at Week 6||Baseline - Week 6|Participant|||Participants|||Count of Participants
2613764|NCT02016885|Secondary|Absolute Change in the Gravimetrically Measured Sweat Production From Baseline to Week 6||Baseline - Week 6|Participant|||mg/5 min||Standard Deviation|Mean
2613770|NCT02016716|Secondary|Percent Change From Baseline in Femoral Neck BMD|Femoral neck BMD was measured using DXA. The analysis was based on an ANCOVA model adjusted for treatment and baseline femoral neck BMD T-score.|Baseline and month 6|All randomized participants who had a baseline and month 6 femoral neck DXA BMD measurement.|||percent change||95% Confidence Interval|Least Squares Mean
2613771|NCT02016716|Secondary|Percent Change From Baseline in Total Hip BMD|Total hip BMD was measured using DXA. The analysis was based on an ANCOVA model adjusted for treatment and baseline total hip BMD T-score.|Baseline and month 6|All randomized participants who had a baseline and month 6 hip DXA BMD measurement.|||percent change||95% Confidence Interval|Least Squares Mean
2613772|NCT02016716|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine|Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).|Baseline and month 6|All randomized participants who had a baseline and a month 6 lumbar spine DXA BMD measurement|||percent change||95% Confidence Interval|Least Squares Mean
2613773|NCT02016690|Secondary|Mean Duration of Respiratory Support|The presence/absence of respiratory support (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) and the start and end dates of respiratory support were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants with available data|||days||Standard Deviation|Mean
2613774|NCT02016690|Secondary|Number of Hospitalized Participants Requiring Respiratory Support|The presence/absence of respiratory support, (oxygen therapy, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure, and other mechanical respiratory support or Intensive Care Unit admission) the start and end dates of respiratory support, and the dates of hospitalization and discharge were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants with available data|||Participants|||Count of Participants
2613775|NCT02016690|Secondary|Mean Hospitalization Length Due to Respiratory Syncytial Virus (RSV) Infection|The date of hospitalization due to RSV infection and the date of hospital discharge were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants with available data|||days||Standard Deviation|Mean
2613776|NCT02016690|Secondary|Number of Participants Hospitalized Due to Respiratory Syncytial Virus (RSV) Infection|Hospitalization due to RSV infection or the presence/absence of positive RSV antigen test results during hospitalization was documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants with available data|||Participants|||Count of Participants
2613777|NCT02016690|Secondary|Change in Lower Respiratory Tract Infection (LRI) Score During the Study|The Lower Respiratory Tract Infection (LRI) Score ranged from 0 (well or baseline); 1 (Upper Respiratory tract Infection [URI]), mild); 2 (LRI); 3 (LRI, moderate); 4 (LRI, severe) to 5 (Respiratory Failure). Components of the score included respiratory rate per minute, oxygen saturation, and physical findings of LRI. LRI scores were documented on the case report form (CRF).|From the first administration of palivizumab up to the last administration of palivizumab, up to 36 weeks|Participants with available data|||units on a scale||Standard Deviation|Mean
2613778|NCT02016690|Primary|Number of Participants With Adverse Drug Reactions|"An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. If a causal relationship with palivizumab was: Related, Causality cannot be ruled out, or Not assessable as determined by the investigator, it was classified as an adverse drug reaction (ADR). An AE was considered a serious adverse event (SAE) and a serious adverse drug reaction (SADR) if the severity of the AE or ADR was any one of the following, as determined by the investigator: Death, Life-threatening condition, Hospitalization or prolonged hospitalization, Persistent or significant disability, or Other medically important condition. Information about AEs and ADRs was documented on the case report form (CRF)."|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.|||Participants|||Count of Participants
2613779|NCT02016690|Primary|Number of Participants With Serious Adverse Events|A serious adverse event was defined as any untoward medical occurrence in a participant that the investigator believed to be causally related to the study treatment and met at least one of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity, or important medical event requiring medical or surgical intervention to prevent serious outcome. Serious adverse events were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.|||Participants|||Count of Participants
2613780|NCT02016690|Primary|Number of Participants With Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with their treatment. Adverse events were documented on the case report form (CRF).|From the first administration of palivizumab to 30 days after the last administration of palivizumab, up to 44 weeks|Participants enrolled via consecutive enrollment method who had a completed CRF. Participants were excluded if there was enrollment at a non-contracting institution or beyond the contracted number; duplicate enrollment; no palivizumab administration; or if palivizumab administration began outside of the investigation period.|||Participants|||Count of Participants
2613822|NCT02016482|Secondary|Percent Change From Baseline in Target Fingernail mNAPSI Score at Week 26|The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percent change||Standard Error|Least Squares Mean
2613781|NCT02016625|Primary|AUC τ,ss (Area Under the Concentration-time Curve of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ)|"AUC τ,ss (area under the concentration-time curve of the FDV [followed by tac treatment] in plasma at steady state over a uniform dosing interval τ).~PK sampling (relative to the first cyclo administration [h:min]):~period 2 For FDV~-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|PKS tac|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2613782|NCT02016625|Primary|C24,ss (Maximum Measured Concentration of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a 24 Hour Dosing Interval)|"PK sampling (relative to the first tac administration [h:min]):~period 2 For FDV~-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|PKS tac|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2613783|NCT02016625|Primary|Cmax,ss (Maximum Measured Concentration of the FDV [Followed by Tac Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ)|"Cmax,ss (maximum measured concentration of the FDV [followed by tac treatment] in plasma at steady state over a uniform dosing interval τ).~PK sampling (relative to the first tac administration [h:min]):~period 2 For FDV~-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|PKS tac|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2613784|NCT02016625|Primary|Cmax (Maximum Measured Concentration of the Tac in Plasma)|"Cmax (maximum measured concentration of the tac in plasma).~PK sampling (relative to the first tac administration [h:min]):~Period 1:~for tac 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h Period 2 For tac~-192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 192 hours (details in description)|PKS tac|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2613785|NCT02016625|Primary|AUC 0-tz (Area Under the Concentration-time Curve of the Tac in Plasma Over the Time Interval From 0 to the Last Quantifiable Point)|"AUC 0-tz (area under the concentration-time curve of the tac in plasma over the time interval from 0 to the last quantifiable point).~PK sampling (relative to the first tac administration [h:min]):~Period 1: for tac~0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h~Period 2 For tac~-192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 192 hours (details in description)|PKS tac|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2613786|NCT02016625|Primary|AUC 0-infinity (Area Under the Concentration-time Curve of the Tac in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"AUC 0-infinity (area under the concentration-time curve of the tac in plasma over the time interval from 0 extrapolated to infinity).~PK sampling (relative to the first tac administration):~Period 1: for tac 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 144:00h, 168:00h, 192:00h period 2 for tac~-192:00h, -168:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 192 hours (details in description)|pharmacokinetic set of tac (PKS tac): The subject set for the evaluation of PK endpoints was to include all treated subjects who provided at least 1 observation of tac in plasma for at least 1 primary endpoint, and who did not have important protocol violations with respect to the statistical evaluation of PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2613787|NCT02016625|Primary|AUC τ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)|"AUC τ,ss (area under the concentration-time curve of the FDV in plasma at steady state over a uniform dosing interval τ).~PK sampling (relative to the first cyclo administration [h:min]):~period 2 For FDV~-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 168 hours (details in description)|PKS cyclo + treated with FDV alone (arm: Faldaprevir) or started combination treatment FDV+cyclosporine in treatment period 2.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2613788|NCT02016625|Primary|C24,ss (Maximum Measured Concentration of the FDV in Plasma at Steady State Over a 24 Hour Dosing Interval)|"PK sampling (relative to the first cyclo administration [h:min]):~period 2 For FDV~-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 168 hours (details in description)|PKS cyclo + treated with FDV alone (arm: Faldaprevir) or started combination treatment FDV+cyclosporine in treatment period 2.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2613789|NCT02016625|Primary|Cmax,ss (Maximum Measured Concentration of the FDV [Followed by Cyclo Treatment] in Plasma at Steady State Over a Uniform Dosing Interval τ)|"Cmax,ss (maximum measured concentration of the FDV [followed by cyclo treatment] in plasma at steady state over a uniform dosing interval τ).~PK sampling (relative to the first cyclo administration [h:min]):~period 2 For FDV~-144:00h, -120:00h, -96:00h, -72:00h, -48:00h, -24:00h, -23:30h, -23:00h, -22:30h, -22:00h, -21:00h, -20:00h, -18:00h, -16:00h, -14:00h, -12:00h, -8:00h, 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 168 hours (details in description)|PKS cyclo + treated with FDV alone (arm: Faldaprevir) or started combination treatment FDV+cyclosporine in treatment period 2.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2614243|NCT02013674|Secondary|Difference in Left Ventricular Volume|Difference in left ventricular end diastolic and end systolic volume will be assessed via ECHO|Baseline, 6 months, 12 months|Data were not available to perform the statistical analyses as described in the protocol for this outcome.||||||
2613790|NCT02016625|Primary|Cmax (Maximum Measured Concentration of the Cyclo in Plasma)|"Cmax (maximum measured concentration of the cyclo in plasma).~PK sampling (relative to the first cyclo administration [h:min]):~Period 1: for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h"|up to 168 hours (details in description)|PKS cyclo|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2613791|NCT02016625|Primary|AUC 0-tz (Area Under the Concentration-time Curve of the Cyclo in Plasma Over the Time Interval From 0 to the Last Quantifiable Point)|"AUC 0-tz (area under the concentration-time curve of the cyclo in plasma over the time interval from 0 to the last quantifiable point).~PK sampling (relative to the first cyclo administration [h:min]):~Period 1:~for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|PKS cyclo|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2613792|NCT02016625|Primary|AUC 0-infinity (Area Under the Concentration-time Curve of the Cyclo in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"AUC 0-infinity (area under the concentration-time curve of the cyclo in plasma over the time interval from 0 extrapolated to infinity).~PK sampling (relative to the first cyclo administration [h:min])~Period 1:~for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h.~period 2 for cyclo 0:00h, 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, 10:00h, 12:00h, 16:00h, 24:00h, 48:00h, 72:00h, 96:00h, 120:00h, 144:00h, 168:00h."|up to 168 hours (details in description)|pharmacokinetic set of cyclo (PKS cyclo): The subject set for the evaluation of PK endpoints was to include all treated subjects who provided at least 1 observation of cyclo in plasma for at least 1 primary endpoint, and who did not have important protocol violations with respect to the statistical evaluation of PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2613793|NCT02016612|Secondary|Percent Breast Tissue Above Nipple|The percentage of breast tissue above and below the horizontal plane of the nipple over time|1 year post op||||percentage of volume||Full Range|Mean
2613794|NCT02016612|Primary|Nipple to Fold Measurement on Stretch|The Nipple to fold will be measured manually over time to 1 year|1 year post op||||centimeters||Full Range|Mean
2613795|NCT02016482|Secondary|Change From Baseline in Nail Psoriasis Quality of Life (Nail PsQoL) Score at Week 26|Participants were asked how their fingernail psoriasis impacted their overall quality of life over the past 7 days on an 11-point scale, with 0 indicating no impact, and 10 indicating severe impact. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
2613796|NCT02016482|Secondary|Percentage of Participants With a New Diagnosis of Psoriatic Arthritis (PsA) During the Study|The percentage of participants with a new diagnosis of PsA (ie, with an adverse event of PsA) during the study, among participants without PsA at Baseline.|up to Week 26|ITT Population in Period A: all participants who were randomized at Baseline and did not have PsA at Baseline. Observed cases.|||percentage of participants|||Number
2613797|NCT02016482|Secondary|Change From Baseline in Hospital Anxiety Depression Scale (HADS) at Week 26|Participants rated their anxiety and depression over the past 7 days at Week 26. The range of possible scores was 0 to 21, with a score of 0 indicating absence of anxiety and depression and 21 indicating the most severe anxiety and depression. A decrease in HADS score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline; n=number of participants with a given assessment. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
2613798|NCT02016482|Secondary|Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 26|The EQ-5D VAS records the participant's self-rated health status on a vertical graduated scale from 0 to 100, with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state. An increase in EQ-5D-5L VAS score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
2613799|NCT02016482|Secondary|Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Health State Assessment at Week 26|The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
2613800|NCT02016482|Secondary|Change From Baseline in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO) at Week 26|"The WPAI: NPSO assessed impact of fingernail psoriasis on work productivity and non-work activity limitation. Participants were asked during the past 7 days, how many hours did you miss from work because of problems associated with your fingernail psoriasis (absenteeism), during the past seven days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your fingernail psoriasis affect your productivity while you were working (overall work impairment), and much did your fingernail psoriasis affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating fingernail psoriasis had no effect on this and 10 indicating fingernail psoriasis completely prevented me from this. A decrease in the WPAI:NPSO score indicates improvement."|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline; n=number of participants with given assessment. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
2614244|NCT02013674|Secondary|Difference in LVEF|As assessed via ECHO|Baseline, 6 months, 12 months|Data were not available to perform the statistical analyses as described in the protocol for this outcome.||||||
2613801|NCT02016482|Secondary|Percentage of Participants Achieving DLQI of 0 and 0/1 at Week 26|Participants assessed symptoms and impacts of dermatologic diseases on their QoL over the past 7 days, with 0 indicating not at all, and 3 indicating very much. The range of possible DLQI scores was 0 to 30, with a score of 0 indicating no effect at all on a participant's life and a score of 30 indicating extremely large effect on participant's life. A decrease in DLQI score indicates improvement. Data presents the percentage of participants with a score of 0 (no effect) or 1 (little effect) at Week 26.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.|||percentage of participants|||Number
2613802|NCT02016482|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 26|Participants assessed symptoms and impacts of dermatologic diseases on their QoL over the past 7 days, with 0 indicating not at all, and 3 indicating very much. The range of possible DLQI scores was 0 to 30, with a score of 0 indicating no effect at all on a participant's life and a score of 30 indicating extremely large effect on participant's life. A decrease in DLQI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
2613803|NCT02016482|Secondary|Percent Change From Baseline in Nail Assessment in NAPPA QoL at Week 26|Participants rated specific impacts of fingernail psoriasis on various aspects of their QoL over the past 7 days on a 5-point scale, with 0 indicating not at all, and 4 indicating very impactful. A participant's overall global score was the mean of all items and could range from 0 to 4, with 0 indicating no impact and 4 indicating most impact. A decrease in NAPPA QoL score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percent change||Standard Error|Least Squares Mean
2613804|NCT02016482|Secondary|Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) at Week 26|Participants rated specific impacts of fingernail psoriasis on various aspects of their QoL over the past 7 days on a 5-point scale, with 0 indicating not at all, and 4 indicating very impactful. A participant's overall global score was the mean of all items and could range from 0 to 4, with 0 indicating no impact and 4 indicating most impact. A decrease in NAPPA QoL score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
2613805|NCT02016482|Secondary|Percent Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26|Participants were asked to rate the impact of their fingernail psoriasis on their ability to perform physical tasks (eg, typing, housework, buttoning a shirt or blouse, picking up coins from a table, tying shoes, yard work, etc.) over the past 7 days on a scale of 0 indicating no impact on ability to perform physical tasks, to 10 indicating severe impact on ability to perform physical tasks. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment (participants with an observed baseline value >0). Multiple imputation.|||percent change||Standard Error|Least Squares Mean
2613806|NCT02016482|Secondary|Percent Change From Baseline in Nail Psoriasis Pain NRS at Week 26|An NRS was used to capture a participant's self-reporting of her/his worst fingernail pain and average fingernail pain due to fingernail psoriasis. The participant rated the severity of fingernail pain over the past 7 days on a scale from 0 indicating no pain, to 10 indicating severe pain. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had an assessment (participants with an observed baseline value >0). Multiple imputation.|||percent change||Standard Error|Least Squares Mean
2613807|NCT02016482|Secondary|Percent Change From Baseline in Total BSA at Week 26|BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percent change||Standard Error|Least Squares Mean
2613808|NCT02016482|Secondary|Change From Baseline in Total Body Surface Area (BSA) at Week 26|BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of affected BSA||Standard Error|Least Squares Mean
2613809|NCT02016482|Secondary|Percentage of Participants Achieving 50% Improvement in the Inverse Psoriasis Component of the B-SNIPI at Week 26|The range of possible B-SNIPI scores was 0 to 20 for inverse psoriasis, with a score of 0 indicating absence of psoriasis and a score of 20 indicating most severe psoriasis. A decrease in B-SNIPI score indicates improvement. Data presents the percentage of participants achieving 50% improvement in the inverse component of the B-SNIPI among participants with a Baseline inverse psoriasis score of ≥ 6.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had Baseline inverse psoriasis score ≥ 6. Inverse psoriasis was assessed for participants enrolled under Protocol Amendment 1 in the US and Puerto Rico only. Multiple imputation.|||percentage of participants|||Number
2613810|NCT02016482|Secondary|"Percentage of Participants Achieving PGA-S of Clear at Week 26"|"The PGA-S is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was assessed, with 0 indicating cleared and 5 indicating severe. A decrease in PGA-S score indicates improvement. Data present the percentage of participants achieving a PGA-S of clear (0) with at least a 2-grade improvement relative to Baseline at Week 26."|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of participants|||Number
2613811|NCT02016482|Secondary|"Percentage of Participants Achieving Physician's Global Assessment of Skin Psoriasis (PGA-S) Clear or Minimal at Week 26"|"The PGA-S is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was assessed, with 0 indicating cleared and 5 indicating severe. A decrease in PGA-S score indicates improvement. Data present the percentage of participants achieving a PGA-S of clear (0) or minimal (1) with at least a 2-grade improvement relative to Baseline at Week 26."|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of participants|||Number
2613812|NCT02016482|Secondary|Percentage of Participants Achieving PASI 75/50/90/100 Responses at Week 26|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. PASI-75, 50, 90, and 100 responses are the percentage of participants with a Baseline PASI score ≥ 5 who achieved at least a 75%, 50%, 90%, or 100% reduction (improvement), respectively, from Baseline in PASI score at Week 26. A 100% reduction was considered complete clearance of psoriasis. Data presents the percentage of participants achieving PASI 75/50/90/100 responses at Week 26 among participants with a Baseline PASI score ≥ 5.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline and had a Baseline PASI score ≥ 5. Multiple imputation.|||percentage of participants|||Number
2613813|NCT02016482|Secondary|Percent Change From Baseline in PASI Score at Week 26|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. A decrease in PASI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percent change||Standard Error|Least Squares Mean
2613814|NCT02016482|Secondary|Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 26|PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. A decrease in PASI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
2613815|NCT02016482|Secondary|Change From Baseline in Total Fingernail NAPSI Score at Week 26|Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
2613816|NCT02016482|Secondary|Percent Change From Baseline in Target Fingernail NAPSI Score at Week 26|The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percent change||Standard Error|Least Squares Mean
2613817|NCT02016482|Secondary|Change From Baseline in Target Fingernail NAPSI Score at Week 26|The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
2613818|NCT02016482|Secondary|Percentage of Participants Achieving Target Fingernail NAPSI Score of 0 at Week 26|The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of participants|||Number
2613819|NCT02016482|Secondary|Percentage of Participants Achieving Total Fingernail NAPSI Score of 0 at Week 26|Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of participants|||Number
2613820|NCT02016482|Secondary|Percent Change From Baseline in Total Fingernail mNAPSI Score at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percent change||Standard Error|Least Squares Mean
2613821|NCT02016482|Secondary|Change From Baseline in Total Fingernail mNAPSI Score at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
2613879|NCT02015754|Other Pre-specified|Exploratory Endpoint -Total Drug Exposure Over Time (AUC) of Irinotecan and SN-38 Post DEBIRI-TACE|Total drug exposure over time (AUC) of irinotecan and its metabolite SN-38 post DEBIRI-TACE in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 10min, 15min, 30min, 1hr, 2hr, 4hr, 6hr, and 24hr post administration of 100mg irinotecan.|24 hours||||ng*h/mL||Standard Deviation|Mean
2613823|NCT02016482|Secondary|Change From Baseline in Target Fingernail mNAPSI Score at Week 26|The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||units on a scale||Standard Error|Least Squares Mean
2613824|NCT02016482|Secondary|Percentage of Participants Achieving Total Fingernail mNAPSI Score of ≤ 2 at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of participants|||Number
2613825|NCT02016482|Secondary|Percentage of Participants Achieving Target Fingernail mNAPSI Score of ≤ 2 at Week 26|The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of participants|||Number
2613826|NCT02016482|Secondary|Percentage of Participants Achieving Target Fingernail mNAPSI Score of 0 at Week 26|The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of participants|||Number
2613827|NCT02016482|Secondary|"Percentage of Participants Achieving Clear or Minimal in Nail Matrix Component of the PGA-F At Week 26"|"The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a nail matrix component of the PGA-F that met definition of clear (0) or minimal (1) among those with a Baseline nail matrix component of moderate or worse."|Week 26|"ITT Population in Period A: all participants who were randomized at Baseline and had a Baseline nail matrix component of moderate or worse. Multiple imputations."|||percentage of participants|||Number
2613828|NCT02016482|Secondary|"Percentage of Participants Achieving Clear or Minimal in Nail Bed Component of the PGA-F at Week 26"|"The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a nail bed component of the PGA-F that met definition of clear (0) or minimal (1) among those with a Baseline nail bed component of moderate or worse."|Week 26|"ITT Population in Period A: all participants who were randomized at Baseline and had a Baseline nail bed component of moderate or worse. Multiple imputation."|||percentage of participants|||Number
2613829|NCT02016482|Secondary|Percentage of Participants With at Least 50% Improvement in the Scalp Component of the Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index (B-SNIPI) at Week 26|The range of possible scores was 0 to 20 for scalp psoriasis, with a score of 0 indicating absence of psoriasis. A decrease in B-SNIPI score indicates improvement. Data presents the percentage of participants achieving 50% improvement in the scalp component of the B-SNIPI among participants with Baseline scalp score of ≥ 6.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Scalp psoriasis was assessed by B-SNIPI at Week 26 for participants enrolled under Protocol Amendment 1 in the US and Puerto Rico only. Multiple imputation.|||percentage of participants|||Number
2613830|NCT02016482|Secondary|Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26|Participants were asked to rate the impact of their fingernail psoriasis on their ability to perform physical tasks (eg, typing, housework, buttoning a shirt or blouse, picking up coins from a table, tying shoes, yard work, etc.) over the past 7 days on a scale of 0 indicating no impact on ability to perform physical tasks, to 10 indicating severe impact on ability to perform physical tasks. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline.|||units on a scale||Standard Error|Least Squares Mean
2613831|NCT02016482|Secondary|Percent Change From Baseline in Nail Psoriasis Pain Numeric Rating Scale (NRS) at Week 26|An NRS was used to capture a participant's self-reporting of her/his worst fingernail pain and average fingernail pain due to fingernail psoriasis. The participant rated the severity of fingernail pain over the past 7 days on a scale from 0 indicating no pain, to 10 indicating severe pain. A negative change from Baseline indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline.|||percent change||Standard Error|Least Squares Mean
2613832|NCT02016482|Secondary|Percentage of Participants Achieving Total Fingernail mNAPSI Score of 0 at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of participants|||Number
2613833|NCT02016482|Secondary|Percent Change From Baseline in Total Fingernail Nail Psoriasis Severity Index (NAPSI) Score at Week 26|Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.|Baseline, Week 26|ITT Population in Period A: all participants who were randomized at Baseline.|||percent change||Standard Error|Least Squares Mean
2614245|NCT02013674|Secondary|Difference Between the Left Ventricular Ejection Fraction (LVEF)|Change in 1-year LVEF by CT as compared to baseline.|Baseline, 12 months|Not all participants were able to complete the procedure.|||Percentage of ejected blood||Full Range|Median
2613834|NCT02016482|Primary|"For United States (US) Regulatory Purposes: Percentage of Participants With a Physician's Global Assessment of Fingernails (PGA-F) of Clear or Minimal at Week 26"|"The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a PGA-F overall global score that met the definition of clear (0) or minimal (1) with at least a 2-grade improvement relative to Baseline at Week 26."|Week 26|ITT Population in Period A: all participants who were randomized at Baseline. Multiple imputation.|||percentage of participants|||Number
2613835|NCT02016482|Primary|Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26|Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. Investigators assessed each nail abnormality for each of a participant's nails by grading 3 features or groups of features (pitting, onycholysis and oil-drop dyschromia, and crumbling) and noting the presence or absence of 4 features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula). The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement. The mNAPSI 75 response is defined as at least 75% reduction from baseline in mNAPSI.|Week 26|Intent-to-treat (ITT) Population in Period A: all participants who were randomized at Baseline.|||percentage of participants|||Number
2613836|NCT02016300|Secondary|Change From Baseline in Cartilage Thickness (Radiographic Outcome)||2 years|Participants who completed the protocol were included in the analysis.|||mm||Standard Deviation|Mean
2613837|NCT02016300|Secondary|Change From Baseline in Cartilage Volume (Radiographic Outcome)||2 years|Participants who completed the protocol were included in the analysis.|||mm^3||Standard Deviation|Mean
2613838|NCT02016300|Secondary|Change From Baseline in T2 Relaxation Time (Radiographic Outcome)|T2 imaging assesses hydration of cartilage as well as collagen fiber orientation and loss of type II collagen.|2 years|Participants who completed the protocol were included in the analysis.|||millisecond (ms)||Standard Deviation|Mean
2613839|NCT02016300|Secondary|Change From Baseline in Lysholm Score (Clinical Outcome)|The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.|2 years|Participants who completed the protocol were included in the analysis.|||units on a scale||Standard Deviation|Mean
2613840|NCT02016300|Secondary|Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome)|SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life. A higher value indicates a better quality of life of the patient. The scores range from 0 to 100.|2 years|Participants who completed the protocol were included in the analysis.|||units on a scale||Standard Deviation|Mean
2613841|NCT02016300|Secondary|Change From Baseline in Tegner Score (Clinical Outcome)|The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score >6 can only be achieved if the person participates in recreational or competitive sport.|2 years|Participants who completed the protocol were included in the analysis.|||units on a scale||Standard Deviation|Mean
2613842|NCT02016300|Primary|Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome)|KOOS is a validated outcome score that evaluates knee symptoms, knee pain, knee use in activities of daily living, function in sport and recreation and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.|2 years|Participants who completed the protocol were included in the analysis.|||units on a scale||Standard Deviation|Mean
2613843|NCT02016235|Primary|Change in Urine Total Protein|Urine protein tests detect and/or measure protein being released into the urine. Normal urine protein elimination is less than 150 mg/day|baseline, day 7|Data were not collected for the Disease Dent Observation Group|||mg/day||Standard Deviation|Mean
2613844|NCT02016183|Secondary|Changes From Baseline in Pulse Rate at Each Time Point|Reported data are changes in Pulse Rate from baseline at Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and final assessment.|Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points. Here 'n' is number of participants analyzed at the given time point.|||Beats per minutes||Standard Deviation|Mean
2613845|NCT02016183|Secondary|Changes From Baseline in Diastolic Blood Pressure (DBP) at Each Time Point|Reported data are changes in DBP from baseline at Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and final assessment.|Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points. Here 'n' is number of participants analyzed at the given time point.|||mmHg||Standard Deviation|Mean
2613846|NCT02016183|Secondary|Changes From Baseline in Systolic Blood Pressure (SBP) at Each Time Point|Reported data are changes in SBP from baseline at Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and final assessment.|Baseline, and Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and Final assessment (up to 12 months)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points. Here 'n' is number of participants analyzed at the given time point.|||mmHg||Standard Deviation|Mean
2613880|NCT02015754|Other Pre-specified|Exploratory Endpoint - Pharmacokinetic (PK) Profile of Irinotecan and SN-38 Post DEBIRI-TACE|PK analysis of irinotecan and its metabolite SN-38 in the first 10 patients enrolled on protocol including peak plasma concentration (Cmax). Time points assessed in protocol were pre-dose, and then 5min, 10min, 15min, 30min, 1hr, 2hr, 4hr, 6hr, and 24hr post administration of 100mg irinotecan.|24 hours||||ng/mL||Standard Deviation|Median
2613847|NCT02016183|Primary|Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)|ADRs are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.|||Participants|||Count of Participants
2613848|NCT02016170|Secondary|Platelet Reactivity Index (PRI) Measured by Whole Blood Vasodilator-stimulated Phosphoprotein (VASP).|The secondary hypothesis of our study was that after 1 week of randomized treatment PRI levels would be non-inferior in patients switched from prasugrel to ticagrelor (two arms combined) compared with patients remaining on prasugrel. VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies.|7 days||||PRI||Standard Deviation|Least Squares Mean
2613849|NCT02016170|Primary|Platelet Reactivity Measured as P2Y12 Reaction Units (PRU) Determined by Verify Now-P2Y12 Assay|The primary hypothesis of our study was that after 1 week of randomized treatment PRU levels would be non-inferior in patients switched from prasugrel to ticagrelor (two arms combined) compared with patients remaining on prasugrel.|7 days|Analysis was conducted in patients who received the randomized treatment and had a valid primary end point value (PRU at 1 week).|||PRU||Standard Error|Least Squares Mean
2613850|NCT02016105|Secondary|ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 51|"Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 51.~Patients with ADA positive results at baseline were excluded from subsequent results."|At Week 51 only|The Safety analysis set (SAF) includes all patients who received at least one dose of study treatment during Treatment Period 1. Patients were analyzed according to the treatment received.|||% patients with at least 1 ADA+ sample|||Number
2613851|NCT02016105|Secondary|ADA Formation Against GP2017 Adalimumab and Humira® Adalimumab From Randomization Until Week 17|"Proportion of patients with at least one confirmed positive anti-drug antibodies (ADA) response to adalimumab from Randomization to Week 17.~Patients with ADA positive results at baseline were excluded from subsequent results."|At Week 17 only|The Safety analysis set (SAF) includes all patients who received at least one dose of study treatment during Treatment Period 1. Patients were analyzed according to the treatment received.|||% patients with at least 1 ADA+ sample|||Number
2613852|NCT02016105|Secondary|DLQI|Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)|At Week 51 only||||% of patients with DLQI of 0 or 1|||Number
2613853|NCT02016105|Secondary|DLQI|Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)|At Week 35 only||||% of patients with DLQI of 0 or 1|||Number
2613854|NCT02016105|Secondary|DLQI|Proportion of patients reporting a DLQI of 0 or 1 (no effect at all on patient's life)|At Week 17 only|The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.|||% of patients with DLQI of 0 or 1|||Number
2613855|NCT02016105|Secondary|IGA Response Rate|"Proportion of patients achieving a score of 0 (clear) or 1 (almost clear) or improved by at least 2 points of the IGA scale compared to baseline at Week 51"|At Week 51 only||||percent of participants|||Number
2613856|NCT02016105|Secondary|IGA Response Rate|"Proportion of patients achieving a score of 0 (clear) or 1 (almost clear) or improved by at least 2 points of the IGA scale compared to baseline at Week 51"|At Week 35 only||||percent of participants|||Number
2613857|NCT02016105|Secondary|IGA Response Rate|"Proportion of patients achieving a score of 0 (clear) or 1 (almost clear) or improved by at least 2 points of the IGA scale compared to baseline at Week 17."|At Week 17 only|The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.|||percent of participants|||Number
2613858|NCT02016105|Secondary|PASI 50, PASI75, PASI 90 and PASI100 Response Rates|Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 51 (Entire Study)|At Week 51 only||||percent of participants|||Number
2613859|NCT02016105|Secondary|PASI 50, PASI75, PASI 90 and PASI100 Response Rates|Proportion of Patients Achieving PASI 50, 75, 90 and 100 at Week 35 (end of Treatment Period 2)|At Week 35 only||||percent of participants|||Number
2613860|NCT02016105|Secondary|PASI 50, PASI 75, PASI 90 and PASI 100 Response Rates|Proportion of patients achieving PASI 50, 75, 90 and 100 at Week 17 (end of Treatment Period 1)|At Week 17 only|The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.|||percent of participants|||Number
2613861|NCT02016105|Secondary|Mean ATE of Percent Change From Baseline in PASI Score up to Week 16 (ANCOVA)|The key secondary efficacy variable was the average treatment effect (ATE) which is the weighted average of % change from baseline in PASI scores between Week 1 and Week 16 (weights based on the time interval between two consecutive visits).|Baseline to Week 16|The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.|||percentage change from baseline||Standard Error|Least Squares Mean
2613862|NCT02016105|Secondary|Mean Percent Change From Baseline in PASI Score up to Week 16 (MMRM)|The key secondary efficacy variable was the percentage change from baseline in PASI score at each visit up to Week 16.|Baseline to Week 16|The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.|||percentage change from baseline||Standard Error|Least Squares Mean
2613863|NCT02016105|Primary|PASI 75 Response Rate at Week 16 - GP2017 Adalimumab vs Humira ® Adalimumab|The primary variable was the PASI75 response rate at Week 16, defined as the proportion of patients achieving a reduction of 75% or more of the PASI score at Week 16 compared with baseline.|At Week 16 only|The Per-protocol analysis set (PPS) consists of patients who completed the study up to Week 16 and had no major protocol deviations or additional exclusion criteria up to and including Week 16.|||percent of participants|||Number
2613864|NCT02015910|Primary|Percent Wounds Healed|Compare the rate of healing as well as percent of wounds healed in Type II diabetic patients with chronic foot ulcerations receiving sitagliptin versus placebo.|12 weeks|Data analysis not completed due to insufficient enrollment.||||||
2613865|NCT02015793|Other Pre-specified|Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 8|Serum samples with adalimumab concentration below 2 μg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 2 μg/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose. No samples were tested because all samples had adalimumab concentrations >2 μg/mL.|Baseline (Week 0) to Week 8|ITT population.||||||
2613866|NCT02015793|Secondary|Fecal Calprotectin: Change From Baseline (Week 0) to Week 8|Stool samples for fecal calprotectin were collected before study drug administration when possible. Decreases in calprotectin are associated with decreased inflammation in the gastrointestinal tract. LOCF was used for missing data.|Baseline (Week 0) and Weeks 4 and 8|ITT population.|||μg/g||Full Range|Median
2613867|NCT02015793|Secondary|High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26|hsCRP was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 3 mg/L, slightly increasing with age. LOCF was used for missing data.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and 26|ITT population.|||mg/L||Full Range|Median
2613868|NCT02015793|Secondary|CDAI: Mean Change From Baseline to Each Visit|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. Scores range from 0 to approximately 600. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Last observation carried forward (LOCF) for missing CDAI observations was used.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26|ITT population.|||units on a scale||Standard Deviation|Mean
2613869|NCT02015793|Secondary|Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26|ITT population.|||percentage of participants||95% Confidence Interval|Number
2613870|NCT02015793|Secondary|Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score of 220 to 450 reflects moderate to severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26|ITT population.|||percentage of participants||95% Confidence Interval|Number
2613871|NCT02015793|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either Reasonable possibility or No reasonable possibility of being related to study drug.~For more details on adverse events please see the AE section below."|35 weeks|Safety Analysis Set.|||participants|||Number
2613872|NCT02015793|Secondary|Number of Participants With Potentially Significant Vital Signs Parameters During Administration of Adalimumab|Blood pressure and pulse were measured while the participant was sitting. The number of participants with a postbaseline vital sign result that meets Common Toxicity Criteria (CTC) version 3.0 (or later) Grade 3 or higher and is also more extreme than the baseline value is summarized. Terms abbreviated in the table include systolic blood pressure (SBP) and diastolic blood pressure (DBP). Increase and decrease are signified by ↑ and ↓, respectively.|26 weeks|Safety Analysis Set.|||participants|||Number
2613873|NCT02015793|Secondary|Number of Participants With Potentially Significant Clinical Chemistry Parameters During Administration of Adalimumab|The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized.|From Week 0 to Week 26|Safety Analysis Set.|||participants|||Number
2613874|NCT02015793|Secondary|Number of Participants With Potentially Significant Hematology Parameters During Administration of Adalimumab|The number of participants with an abnormal laboratory result meeting Common Toxicity Criteria (CTC) Version 3.0 (or later) of Grade 3 or higher is summarized. n=the number of participants with CTC Grade <3 at baseline and a post-baseline value for each parameter.|26 weeks|Safety Analysis Set: all participants who received at least 1 dose of study drug.|||participants|||Number
2613875|NCT02015793|Primary|Mean Serum Adalimumab Concentration at Week 8|Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method.|Week 8|All participants in the intent-to-treat (ITT) population, defined as all randomized participants who received at least 1 dose of double-blind study drug, who had evaluable data.|||μg/mL||Standard Deviation|Mean
2613876|NCT02015754|Other Pre-specified|Exploratory Endpoint - Angiogenesis|Changes in vascular endothelial growth factors (VEGF), VEGF receptors VEGFR1 and VEGFR2 pre- and post- DEBIRI treatment examined for significant effects as well as association with DEBIRI treatment. One-sample Wilcoxon signed rank test was utilized to compare whether %change of VEGF, VEGFR1, or VEGFR2 from baseline was equal to 0. For groups with non-zero percent changes, the 95% confidence intervals were provided.|24 hours||||% change from baseline||95% Confidence Interval|Median
2613877|NCT02015754|Other Pre-specified|Plasma Half-life of Irinotecan and SN-38 Post DEBIRI-TACE|Plasma half-life (t 1/2) of irinotecan and its metabolite SN-38 post DEBIRI-TACE in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 10min, 15min, 30min, 1hr, 2hr, 4hr, 6hr, and 24hr post administration of 100mg irinotecan.|24 hours||||hours||Standard Deviation|Median
2613878|NCT02015754|Other Pre-specified|Exploratory Endpoint -Tmax of Irinotecan and SN-38 Post DEBIRI-TACE|Time taken to reach maximum concentration (Tmax) of irinotecan and its metabolite SN-38 post DEBIRI-TACE in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 10min, 15min, 30min, 1hr, 2hr, 4hr, 6hr, and 24hr post administration of 100mg irinotecan.|24 hours||||hours||Standard Deviation|Median
2613884|NCT02015754|Secondary|Efficacy - Tumor Response by World Health Organization (WHO) Criteria|"Efficacy as assessed by radiographic tumor response using WHO criteria at baseline and at 6-week imaging following TACE treatments.~Complete Response (CR): No lesions detected for at least 4 weeks. Partial Response (PR): 50% or greater decrease in the sum of the products of diameters Stable Disease (SD): Cases that do not fit the criteria of PR or PD. Progressive Disease (PD): 25% or greater increase in the sum of the products of diameters in one or more lesions; or new lesions"|24 weeks||||Participants|||Count of Participants
2613885|NCT02015754|Secondary|Efficacy -Tumor Response by European Association for the Study of the Liver (EASL) Criteria|"Efficacy as assessed by radiographic tumor response using EASL amendment at baseline and at 6-week imaging following TACE treatments.~Complete Response (CR): Achieving 100% tumor necrosis of lesions targeted by DEBIRI-M1. Baseline degree of tumor enhancement used as a reference.~Partial Response (PR): Demonstrating greater than 50% tumor necrosis in lesions targeted by DEBIRI-M1.~Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression of lesions targeted by DEBIRI-M1.~Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in lesions previously targeted by DEBIRI-M1."|24 weeks||||Participants|||Count of Participants
2613886|NCT02015754|Secondary|Efficacy - Tumor Response by mRECIST|"Efficacy as assessed by radiographic tumor response using modified RECIST (mRECIST) criteria at baseline and at 6-week imaging following TACE treatments.~Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions Partial Response (PR): At least 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions Progressive Disease (PD): At least 20% increase in sum of diameters of viable target lesions, taking as reference the smallest sum of diameters of viable target lesions since treatment started.~Stable Disease (SD): Any cases that do not qualify for either PR or PD."|24 weeks||||Participants|||Count of Participants
2613887|NCT02015754|Secondary|Efficacy - Tumor Response by RECIST|"Efficacy as assessed by radiographic tumor response using the RECIST criteria at baseline and at 6-week imaging following TACE treatments.~Complete Response (CR): Disappearance of all lesions targeted by DEBIRI-M1 Partial Response (PR): At least 30% decrease in sum of longest diameter (LD) of lesions targeted by DEBIRI-M1, taking as reference the baseline sum LD Progressive Disease (PD): At least 20% increase in sum of the LD Of lesions targeted by DEBIRI-M1, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, of lesions targeted by DEBIRI-M1, taking as reference the smallest sum LD since treatment started"|24 weeks||||Participants|||Count of Participants
2613888|NCT02015754|Primary|Safety, Defined as Demonstrating Tolerable Device-related Toxicity Profile in the Use of DEBIRI Beads Used to Treat Hepatic Metastases in Patients With Colorectal Cancer|Toxicities assessed as being at least possibly related will be recorded including system organ class, subclass, grade, frequency and time interval from DEBIRI-M1.|6 weeks|6-week toxicity report of device-related adverse events for all 14 participants. Classification and grading based on CTCAE v4.0.|||Participants|||Count of Participants
2613889|NCT02015754|Primary|Success of DEBIRI-M1 Procedure as a Measure of Feasibility (Percentage of Successful Treatments)|Feasibility is defined as achieving an acceptable level of technical success in the use of DEBIRI beads treating hepatic metastases in patients with colorectal cancer.|6 months|The 14 patients received a total of 32 DEBIRI-M1 TACE procedures.|||percentage of successful treatments|DEBIRI-M1 Treatments||Number
2613890|NCT02015676|Secondary|Overall Survival|The time, in months, from the start of treatment to OS event. The mean survival time and it's standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||months||Standard Error|Mean
2613891|NCT02015676|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the date of the start of treatment to the date of death or the last date the participant was known to be alive.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||percentage of participants|||Number
2613892|NCT02015676|Secondary|Time to Therapy Failure|The median time, in months, from treatment start to therapy failure event. Participants were censored at the last date of treatment if no event was recorded.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||months||95% Confidence Interval|Median
2613893|NCT02015676|Secondary|Time to Therapy Failure - Percentage of Participants With an Event|Therapy failure was defined as the date of the start of therapy to the date of withdrawal due to adverse events, progressive disease/insufficient therapeutic response, death, failure to return, or refusal of treatment/lack of cooperation/withdrawal of consent. Participants were censored at the last dose of treatment if no event was recorded.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||percentage of participants|||Number
2613894|NCT02015676|Secondary|Duration of Response|The median time, in months, from enrollment to duration of response event to Week 52.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||months||95% Confidence Interval|Median
2613895|NCT02015676|Secondary|Duration of Response - Percentage of Participants With an Event|Duration of response was defined as the time from date CR was first recorded to the date progressive disease (PD) was first noted. For measurable disease, PD was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of >2 cm^2, or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of ≥1 cm^2. For immeasurable disease, PD was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|Only participants with a response were included in the analysis.|||percentage of participants|||Number
2614246|NCT02013674|Secondary|Difference Between Left Ventricular End Diastolic Wall Thickness|As determined by Computed Tomography Scan|Baseline, 12 Months|Data were not available to perform the statistical analyses as described in the protocol for this outcome.||||||
2613897|NCT02015676|Secondary|Time to Treatment Response - Percentage of Participants With an Event|Treatment response was defined as the time from the start of treatment to the date of recorded CR or PR of measurable disease.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||percentage participants|||Number
2613898|NCT02015676|Secondary|Time to Disease Progression|The median time, in months, from the start of treatment to disease progression event.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||months||95% Confidence Interval|Median
2613899|NCT02015676|Secondary|Time to Disease Progression - Percentage of Participants With an Event|Disease progression was defined as the time from the start of treatment to the date of the first recorded incident of disease progression, or the date of death due any cause. For measurable disease, disease progression was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of greater than (>)2 square centimeters (cm^2), or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of ≥1 cm^2. For immeasurable disease, disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions.|BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||percentage of participants|||Number
2613900|NCT02015676|Primary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment|For measurable disease, CR was defined as the disappearance of all clinically detectable disease determined by 2 observations not less than 4 weeks apart; and PR was defined as a 50 percent (%) decrease in the sum of the products of the 2 greatest diameters of all measurable lesions by 2 observations not less than 4 weeks apart, and no appearance of new lesions or progression of any lesion. For immeasurable disease, CR was defined as the complete disappearance of all known disease for at least 4 weeks; and PR was defined as an estimated decrease in tumor size of 50% or more for at least 4 weeks.|Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)|All participants enrolled in Phase II of this study were included in the analysis.|||percentage of participants|||Number
2613901|NCT02015663|Secondary|Change From Baseline in Tobramycin Minimal Inhibitory Concentration for Pseudomonas Aeruginosa|Change from baseline in tobramycin minimal inhibitory concentration for Pseudomonas aeruginosa will be measured by laboratory testing.|Baseline and day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
2613902|NCT02015663|Secondary|Duration of Use of Anti-pseudomonal Antibiotic|Number of days of use of anti-pseudomonal antibiotic per patient will be assessed.|Day 1 to day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
2613903|NCT02015663|Secondary|Percentage of Patients Who Use Anti-pseudomonal Antibiotic|Percentage of patients who use anti-pseudomonal antibiotic will be assessed.|Day 1 to day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
2613904|NCT02015663|Secondary|Time to First Usage of Anti-pseudomonal Antibiotic|Time to first usage of anti-pseudomonal antibiotic per patient will be assessed by number of days|Day 1 to day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
2613905|NCT02015663|Secondary|Length of Hospital Stay Due to Respiratory-related Events|The number of days in length of hospital stay per patient due to respiratory-related events will be measured.|Day 1 to day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
2613906|NCT02015663|Secondary|Percentage of Patients With Hospitalizations Due to Respiratory-related Events|Percentage of patients with hospitalization due to respiratory-related events|Day 1 to day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
2613907|NCT02015663|Secondary|Time to First Hospitalization Due to Respiratory-related Events|Time to the first hospitalization due to respiratory-related events (number of days) per patient.|Day 1 to day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
2613908|NCT02015663|Secondary|Change From Baseline in Pseudomonas Aeruginosa Sputum Density|Change from baseline in Pseudomonas aeruginosa sputum density will be measured by log10 colony forming units per gram of sputum.|Baseline and day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
2613944|NCT02015065|Secondary|Percentage of Participants Overall Survival|Overall survival is defined as the date of on-study to the date of death from any cause or last follow up.|Overall survival was computed using the number of months from the date of on study to the date of death, an average of 12 months.||||percentage of participants||95% Confidence Interval|Number
2613909|NCT02015663|Secondary|Percent Change From Baseline in Forced Expiratory Flow (FEF) 25%-75% Predicted|The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. A positive change from baseline in FEF indicates improvement in lung function. The predicted percent will be assessed.|Baseline and day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
2613910|NCT02015663|Secondary|Percent Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted|Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.|Baseline and Day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
2613911|NCT02015663|Secondary|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Percent Predicted|"The Forced Expiratory Volume in 1 second (FEV1) percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 percent predicted indicates improvement in lung function."|Baseline and Day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
2613912|NCT02015663|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second ( FEV1) Percent Predicted|"The Forced Expiratory Volume in 1 second (FEV1) percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 percent predicted indicates improvement in lung function."|Baseline and Day 168|The study intended to randomize 200 patients within 18 months; however, after 9 months, only 32 patients were successfully randomized, with a screen fail rate of 50%. Study was terminated with only safety data analyzed. No data collected met the pre-specified powering of 200 patients needed for analysis (only 32 patients randomized)||||||
2613913|NCT02015637|Secondary|Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital Microbiologically Evaluable (UME) Population|Cure for the seconday outcome measure was defined as the eradication of N. gonorrhoeae at TOC as determined by a negative culture obtained from the urogenital site, which was positive at study entry, and with no additional antibiotics with activity against N. gonorrhoeae being administered from study entry through TOC.|Day 7 (± 3 days)|Urogenital ME (UME): All subjects included in the UMITT analysis set who received study drug and had no important protocol deviations that would affect the assessment of efficacy|||Participants|||Count of Participants
2613914|NCT02015637|Primary|Number of Subjects With Cure or Failure of Urogenital Gonorrhea at Test of Cure (TOC) in the Urogenital MITT (UMITT) Population|Cure for the primary outcome measure was defined as the eradication of N. gonorrhoeae at TOC as determined by a negative culture obtained from the urogenital site, which was positive at study entry, and with no additional antibiotics with activity against N. gonorrhoeae being administered from study entry through TOC.|Day 7 (± 3 days)|The primary efficacy analysis was done on the UMITT population, which included all subjects in the ITT analysis set who had a positive culture for N gonorrhoeae obtained at a urogenital site at the Entry Visit, and who did not receive antibiotic therapy for a C trachomatis infection that was potentially effective against N gonorrhoeae prior to TOC.|||Participants|||Count of Participants
2613915|NCT02015546|Secondary|MADRS Remission|MADRS remission is defined as MADRS score < 10|Week 8||||participants|||Number
2613916|NCT02015546|Secondary|MADRS Response|Number of subjects who had a ≥ 50% decrease in MADRS score from baseline|Baseline, Week 8||||participants|||Number
2613917|NCT02015546|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Scale|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, 8 week||||units on a scale||Standard Deviation|Mean
2613918|NCT02015546|Secondary|Change in Clinical Global Impression-Improvement (CGI-I) Scale|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Baseline, Week 8||||units on a scale||Standard Deviation|Mean
2613919|NCT02015546|Secondary|Change in Sheehan Disability Scale (SDS)|The Sheehan Disability Scale assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.|Baseline, 8 week||||units on a scale||Standard Deviation|Mean
2613920|NCT02015546|Secondary|Change in Hamilton Anxiety Rating Scale (HAM-A) Total Scores|HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety.|Baseline, 8 weeks||||units on a scale||Standard Deviation|Mean
2613992|NCT02014584|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in the Double-blind Treatment Period|The Baseline blood presssure assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 12 and Week 24|Safety Population|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2613921|NCT02015546|Primary|Change in Safety as Assessed by the Arizona Sexual Experience Scale (ASEX)|"The Arizona Sexual Experience Scale (ASEX) is a 5-item, patient selfrated scale that evaluates a patient's recent sexual experience. Patients are asked to assess their own experience over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a 6-point scale for each item. The ASEX is used to identify individuals with sexual dysfunction. Possible total score ranges from 5 to 30, with the higher score indicating more patient sexual dysfunction."|Baseline, Weeks 8||||units on a scale||Standard Deviation|Mean
2613922|NCT02015546|Primary|Change in the Discontinuation Emergent Signs and Symptoms Check List (DESS)|"DESS: a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The primary tolerability measure for discontinuation symptoms will be The Discontinuation Emergent Signs and Symptoms Check List (DESS). Discontinuation symptoms that do not respond to education and supportive psychotherapy will be managed by reinstituting the last dose of Vilazodone at which patients did not experience discontinuation symptoms and slowly tapering the dose over 1 week or longer, if necessary.~Total possible range is 0 to 172. A higher score indicates more symptoms."|Baseline, week 9||||units on a scale||Standard Deviation|Mean
2613923|NCT02015546|Primary|Change in Total MADRS Scores From Baseline to Week 8|The efficacy of switching to three different doses of vilazodone (10 mg/d, 20 mg/d, 40 mg/d) from equivalent dose range of generic SSRIs or SSNRIs in patients with MDD measured by the MADRS. The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.|Baseline, Week 8||||units on a scale||Standard Deviation|Mean
2613924|NCT02015481|Secondary|SWAL-QOL, Swallowing Quality of Life Questionnaire|Summary of Quality of Life in Swallowing Disorders total symptom score results over time, change from baseline at weeks 12 and 24 This is a 100 point scale. The higher the number the better the quality of life.|28 weeks||||percentage change from baseline||Standard Deviation|Mean
2613925|NCT02015481|Secondary|Videofluoroscopy (VFS) Score|Penetration aspiration score results assessed by VFS comparing baseline, prior to treatment, to week 24. This is an 8 point scale. The higher the number the greater the risk of aspiration. The result reported is the difference from the baseline scores.|24 Weeks|11 patients had valid baseline data and week 24 data|||Points on an 8 point scale||Standard Deviation|Mean
2613926|NCT02015481|Secondary|Drinking Test Score|Change from baseline in ice water drinking time, in seconds, at week 24. Times greater than 8 seconds to complete the drinking test are considered abnormal.|24 weeks|22 patients had data available for analysis at week 24|||percentage change from baseline||Standard Deviation|Mean
2613927|NCT02015481|Primary|Safety Lab Evaluations|Change from baseline in safety labs including hematology, coagulation, chemistry, renal function, and liver function tests at week 24 .|24 weeks|24 patients were available for analysis at week 24. Not all patients had all labs performed. Missing data accounts for the differing number of patients with specific lab values.|||percentage change from baseline||Standard Deviation|Mean
2613928|NCT02015442|Secondary|Changes in Fasting Triglyceride Levels|Triglyceride levels assessed from plasma in fasting state|Baseline and 7 days||||mmol/l||Standard Deviation|Mean
2613929|NCT02015442|Primary|Percentage Change in Liver Fat|Liver fat was assessed by magnetic resonance spectrometry (MRS)|7 days||||percentage of change||Standard Deviation|Mean
2613930|NCT02015234|Secondary|Responder Analysis of Patient's Global Impression of Change (PGIC)|"PGIC is a fibromyalgia-specific validated instrument to gauge the patient's assessment of change in condition.The scores are categorized as provided below. A responder was defined by a score of 1 (very much improved), or 2 (much improved).~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse"|Months 1, 3, 6, 9, 12|Patients who took at least 1 dose of study drug prior to study discontinuation were included in the efficacy analysis. Overall, 36 patients from the Placebo - TNX-102 SL group and 25 patients from the TNX-102 SL - TNX-102 SL group had discontinued the study early. Any missing PGIC responses were included in the “scores 3-7” for that visit.|||Participants|||Count of Participants
2613931|NCT02015234|Secondary|Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall|The NRS for average pain over the past 7 days was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 7-day recall basis.|Month 1, 3, 6, 9, 12|Patients who took at least 1 dose of study drug prior to study discontinuation were included in the efficacy analysis. By the end of the study, 36 patients from the Placebo - TNX-102 SL group and 25 patients from the TNX-102 SL - TNX-102 SL group had discontinued the study.|||Scores on a scale||Standard Deviation|Mean
2613932|NCT02015234|Secondary|Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall|The NRS for average pain was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 24-hour recall basis.|Months 1, 3, 6, 9 and 12.|Patients who took at least 1 dose of study drug prior to study discontinuation were included in the efficacy analysis. By the end of the study, 36 patients from the Placebo - TNX-102 SL group and 25 patients from the TNX-102 SL - TNX-102 SL group had discontinued the study.|||Scores on a scale||Standard Deviation|Mean
2613933|NCT02015234|Primary|Newly-emergent Adverse Events (NEAEs) During Treatment With TNX-102 SL Tablets Taken Daily at Bedtime Over 12 Months in Patients With Fibromyalgia.|NEAEs and Serious Adverse events (SAEs) were collected and are coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA).|Up to 12 months|All of the 158 enrolled patients took at least 1 dose of study drug and were included in the safety analysis population.|||Participants|||Count of Participants
2613934|NCT02015221|Primary|Ease of Use and Comfort for Subjects Using the ACTitouch System.|Ease of application and removal (donning and doffing) the treatment at the baseline visit. Comfort of treatment after the treatment was first applied.|30 days||||Percent of participants|Participants|95% Confidence Interval|Number
2614011|NCT02014584|Primary|Number of Participants With AE Related to Sexual Function in the Open-label Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.|24 weeks|Open-Label Period Population: all participants who entered the open-label period.|||Participants|||Number
2613935|NCT02015195|Primary|Mean Change in Erythema (Redness) in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (3) Taken Over 24 Hours|"Visual inspection of sting sites will be done at 30 minutes post sting (after treatment completed), 1 hour post sting, and 24 hours post sting. Erythema Index (EI) imeasures increase in cutaneous vasodilation. A computer-measured (Image-J software) EI was used to remove subjectivity. A numeric score was created for the level of erythema, with 0 representing baseline erythema on the control arm. Any positive number indicates more and negative number less erythema on treatment arm compared to placebo. EI values were measured on a scale from -20 to +20 with 0 being the midpoint where there would be equal amounts of erythema on both the treatment and control arm. The erythema they experienced on the treatment arm was then measured as more erythema (a positive value up to 20) or less erythema (a negative value up to -20)."|30 minutes, 1 hour, and 24 hours||||units on a scale||95% Confidence Interval|Mean
2613936|NCT02015195|Primary|Mean Change in Pain in the Treated Human Arm (Not Placebo) From Baseline Determined by Measures (17) Taken Over 24 Hours|"Pain is measured on a scale of 1-10 with 0 being no pain and 10 being worse pain ever felt. Baseline pain will be measured immediately after being stung for 2 minutes without any treatment. Subsequent pain felt at every 2 minutes for 30 minutes, at 1 hour post sting, and at 24 hours post sting will be based on changes from the original baseline pain. Mean change is defined as the mean change in pain from all time points measured from each participant and then averaged for each group. The control arm (placebo) was collected and analyzed in parallel to the treatment arm. The mean change for the treatment arm was then compared with the mean change for the control arm as a baseline. Hence, the data presented are the estimated effect for each treatment group compared to the control arms for each group."|24 hours|one participant excluded because of adverse local skin reaction to household ammonia|||units on a scale||95% Confidence Interval|Mean
2613937|NCT02015104|Secondary|Overall Survival (OS)|OS is defined as the time from treatment start date until date of death or date last known alive.|up to 50 months|One patient withdrew consent after the first dose of drug in the BCG + PANVAC group. One patient withdrew consent prior to treatment in the BCG Alone group.|||Months||95% Confidence Interval|Median
2613938|NCT02015104|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Serious and non-serious adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Adverse events were assessed from the date treatment consent was signed to the date off study. Approximately 50 months and 12 days for BCG + PANVAC Arm/Group, and 43 months and 12 days for BCG Alone Arm/Group.|One patient withdrew consent prior to treatment in the BCG Alone group.|||Participants|||Count of Participants
2613939|NCT02015104|Secondary|Time to Recurrence|TTR is the duration of time measured from the start of TICE BCG therapy (week 3) until recurrence is noted. Recurrence is suspected and/or determined by urine cytology and/or cystoscopic exam and then confirmed pathologically after a TURBT. Positive cytology in the absence of pathologic confirmation is not considered to be a recurrence.|Week 3 until recurrence or 12 months (whichever occurred first)|One patient withdrew consent after the first dose of drug in the BCG + PANVAC group. One patient withdrew consent prior to treatment in the BCG Alone group.|||Months||95% Confidence Interval|Median
2613940|NCT02015104|Secondary|Percentage of Participants Without Progression (Progression-Free Survival (PFS)) at 6 and 12 Months|PFS is the duration of time from start of TICE BCG therapy (week 3) to time of progression or death due to any cause in each study arm, whichever occurs first. Progression is defined as upstaging from a lower stage to a higher stage (e.g., Ta to T1 or T1 to T2-4; or any N+ or M+ in these high grade tumors.).TNM Classification in non-muscle invasive bladder cancer: Ta = Non-invasive papillary carcinoma; T1 = Tumor invades the subepithelial connective tissue; T2-4 = size of primary tumor; N+ or M+ = lymph node involvement and metastasis.|Assessed from start of therapy to 6 and 12 months following therapy|One patient withdrew consent after the first dose of drug in the BCG + PANVAC group. One patient withdrew consent prior to treatment in the BCG Alone group.|||percentage of participants||95% Confidence Interval|Number
2613941|NCT02015104|Primary|Percentage of Participants Without Recurrence (Recurrence-free Survival (RFS)) With Bacillus Calmette-Guerin (BCG) + PANVAC Compared With BCG Alone at 6 and 12 Months|RFS is defined as the time from the start of intravesical Bacillus Calmette-Guerin (TICE BCG) therapy (week 3) until disease recurrence or death due to any cause in each arm. Recurrence is suspected and/or determined by urine cytology and/or cystoscopic exam and then confirmed pathologically after a transurethral resection of bladder tumor (TURBT). Positive cytology in the absence of pathologic confirmation is not considered to be a recurrence.|Assessed from start of therapy to 6 and 12 months following therapy|One patient withdrew consent after the first dose of drug in the BCG + PANVAC group. One patient withdrew consent prior to treatment in the BCG Alone group.|||percentage of participants||95% Confidence Interval|Number
2613942|NCT02015065|Secondary|Maximum Standardized Uptake Value (SUVmax) on Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)|The maximum standardized uptake value (SUVmax) was used to measure the uptake of FDG-PET by the Gastrointestinal Tumors.|Baseline and at a subsequent PET performed on or about day 3-6 of cycle 1|Data were only collected from patients >/= 15 years of age.|||g/mL||Full Range|Median
2613943|NCT02015065|Secondary|Progression Free-Survival|Progression free survival is defined as the time interval from start of treatment to documented evidence of disease progression. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).|Patients will be evaluated approximately 60 days after last dose of investigational drug until removal of protocol therapy, an average of 12 months.||||Months||95% Confidence Interval|Median
2614240|NCT02013674|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Reads.|The number of participants with abnormal ECG readings via 24 hour ambulatory ECG recordings as assessed per treating physician discretion.|12 months|Not all participants were able to complete the procedure.|||Participants|||Count of Participants
2613945|NCT02015065|Secondary|Count of Participants With Serious and Non-serious Adverse Events|The count of participants with serious and non-serious adverse events was assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 32 months and 1 day.||||Participants|||Count of Participants
2613946|NCT02015065|Primary|Number of Participants With a Clinical Activity-radiographic Response|Clinical activity will be assessed primarily by radiographic response of measurable disease using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study); (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease is neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progressive Disease, taking as reference the smallest sum diameters while on study.|Every 3 cycles x4 and then every 6 cycles (1 cycle = 28 days) until removal from protocol therapy, an average of 12 months.||||Participants|||Count of Participants
2613947|NCT02015039|Secondary|Using a Patient Rated Subjective Scale (Visual Analogue Scale), Change From Baseline With Botulinum Toxin Therapy Plus Occupational Therapy Compared to Botulinum Toxin Therapy Alone at 24 Weeks.|"A visual analogue scale was used to rate patient's subjective rating of the severity of their writer's cramp at each visit. Patients were asked to mark the location on a 10 centimeter line corresponding to the severity of their writer's cramp. Ratings ranged from mild disease severity to severe disease severity. The mark was measured on the 10 centimeter line, ranging from 0 to 10. The percent change in the patient rated subject scale was measured at baseline (Visit 1) and 24 weeks (Visit 9) in the two groups."|Baseline and 24 weeks|The patient rated subjective scale was not administered at baseline in two subjects, i.e., one subject in each group, therefore these subjects were not included in the analysis.|||percentage of change||Standard Deviation|Mean
2613948|NCT02015039|Secondary|Change in Quantitative Writing Metrics Obtained Via Numerical Analyses of Writing Samples Using a Digitizing Tablet.|Subjects with writer's cramp were instructed to draw with their dominant hand between the lines of a 5-loop Archimedes spiral presented on a paper placed over the surface of a digitizing tablet sampling pen tip position at a 100 Hz. The deviation of the drawn spiral to the ideal spiral was calculated at each sampled point. The root mean square of the total spiral error was used as a measure of dysfunctional pen control in subjects with writer's cramp compared with normative data. The percent change of the root mean square was calculated at baseline (Visit 1) and 20 weeks (Visit 8) in the two groups.|Baseline and 20 weeks||||percentage of change||Standard Deviation|Mean
2613949|NCT02015039|Secondary|Change in Hand Grip Strength From Baseline to 20 Weeks Following Botulinum Toxin Therapy Alone and Botulinum Toxin Therapy Plus Occupational Therapy.|Hand grip strength was measured using a commercially available dynamometer. The dynamometer instrument measures maximum isometric strength of the hand and forearm muscles. Hand grip strength was measured with the dynamometer during each visit. The percent change in hand grip strength between baseline (Visit 1) and 20 weeks (Visit 8) in the two groups.|Baseline and 20 weeks||||percentage of change||Standard Deviation|Mean
2613950|NCT02015039|Secondary|Change on the Writer's Cramp Disability Scale (WCDS) Score From Baseline to 20 Weeks.|"The Writer's Cramp Disability Scale (WCDS) is a self-reported questionnaire which queries patients regarding problems they experience with writing and other every day activities due to writer's cramp. The scale ranges from 0-42 with 0 representing no difficulty and 42 representing marked difficulty. The percent change in the WCDS was measured at baseline (Visit 1) and 20 weeks (Visit 8) in the two groups."|Baseline and 20 weeks|The Writer's Cramp Disability Scale (WCDS) was not administered at baseline for one subject in the Botulinum Toxin Therapy Only group therefore this subject was not included in the analysis.|||percentage of change||Standard Deviation|Mean
2613951|NCT02015039|Secondary|Change on the Writer's Cramp Impairment Scale (WCIS) Score From Baseline to 20 Weeks.|"The Writer's Cramp Impairment Scale (WCIS) scale assesses the speed of writing, the number of breaks during writing, the occurrence and intensity of involuntary (pathological) postures/abnormal movements (while writing, while performing repetitive wrist movements), the degree of tremor that occurs while performing repetitive spiral movements, and the presence of mirror movements. The scale ranges from 0-180 with 0 representing no impairment and 180 representing severe impairment. The percent change in the WCIS was measured at baseline (Visit 1) and 20 weeks (Visit 8) in the two groups."|Baseline and 20 weeks|The Writer's Cramp Impairment Scale (WCIS) was not collected at week 20 for two subjects in the Botulinum Toxin Therapy plus Occupational Therapy group, therefore these two subjects were not included in the analysis.|||percentage of change||Standard Deviation|Mean
2613952|NCT02015039|Secondary|Change in the Writers Cramp Rating Scale (WCRS) From Baseline to Week 20 in Participants Receiving Botulinum Toxin Therapy Alone Compared With Botulinum Toxin Therapy Plus Occupational Therapy.|"The Writers Cramp Rating Scale (WCRS) is a tool used to quantify the treatment effect of local botulinum toxin injections in writer's cramp using writing performance and a computer assisted analysis of writing speed. The WCRS consists of two parts. Part A provides a writing movement score measuring 1) dystonic posture elbow score (ES: 0-2), 2) wrist score (WRS: 0-4), 3) finger score (FS: 0-6), 4) latency of dystonia (L: 1-2) and 5) writing tremor (WT: 0-2). The writing movement sub-score is calculated as (ES + WRS + FS) x L + (WT x 2) (0-28). Part B provides an assessment of writing speed (WS: 0-2). The WCRS score is the total of the writing movement sub-score and the writing speed sub-score. The total WCRS range is between 0 indicating absent residual writer's cramp symptoms to 30 indicating severe writer's cramp symptoms. The percentage change in the WCRS was measured at baseline (Visit 1) and 20 weeks (Visit 8) in the two groups."|Baseline and 20 weeks||||percentage of change||Standard Deviation|Mean
2617237|NCT01982331|Primary|Percentage of Participants With Immediate Reactions|Measured as observed by study staff or reported by the subject to study staff whether related or not related.|2 hours||||Participants|||Count of Participants
2613953|NCT02015039|Primary|Using a Patient Rated Subjective Scale (Visual Analogue Scale), Change From Baseline With Botulinum Toxin Therapy Plus Occupational Therapy Compared to Botulinum Toxin Therapy Alone at 20 Weeks.|"A visual analogue scale was used to rate patient's subjective rating of the severity of their writer's cramp at each visit. Patients were asked to mark the location on a 10 centimeter line corresponding to the severity of their writer's cramp. Ratings ranged from mild disease severity to severe disease severity. The mark was measured on the 10 centimeter line, ranging from 0 to 10. The percent change in the patient rated subject scale was measured at baseline (Visit 1) and 20 weeks (Visit 8) in the two groups."|Baseline and 20 weeks|The patient rated subjective scale was not administered at baseline in two subjects, i.e., one subject in each group, therefore these subjects were not included in the analysis.|||percentage of change||Standard Deviation|Mean
2613954|NCT02014740|Primary|Echocardiographic Epicardial Fat Thickness|Echocardiographic epicardial fat thickness is an non invasive, inexpensive, reproducible and direct measure of visceral fat. In fact, epicardial fat strongly reflects the intra-abdominal and intra-myocardial fat accumulation as measured by magnetic resonance imaging procedures.|6 months||||mm||Standard Deviation|Mean
2613955|NCT02014584|Secondary|Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions Open-label Treatment Period|The global assessment questions consist of 2 questions, recording how much the participant perceives his sexual life has changed and how he perceives his ability to achieve and maintain erections has changed, compared to how it was before he began receiving treatment in this study. The wording of these questions were based on the Patient Global Impression of Improvement questionnaire, which was validated for use in the assessment of improvement in stress urinary incontinence. The questions were scored on a 7-point scale.The Baseline assessment was defined as the latest assessment on or before the OL treatment start.|Baseline and up to Week 24|open-label period population|||Participants|||Number
2613956|NCT02014584|Secondary|Change From Baseline in Participants Perception of Sexual Function Measured by Responses to the Global Assessment Questions in the Double-blind Treatment Period|The global assessment questions consist of 2 questions, recording how much the participant perceives his sexual life has changed and how he perceives his ability to achieve and maintain erections has changed, compared to how it was before he began receiving treatment in this study. The wording of these questions were based on the Patient Global Impression of Improvement questionnaire, which was validated for use in the assessment of improvement in stress urinary incontinence. The questions were scored on a 7-point scale.The Baseline assessment was defined as the latest assessment on or before the DB treatment start.|Baseline and up to Week 24|Safety Population|||Participants|||Number
2613957|NCT02014584|Secondary|Change From Baseline in the Total Score of the DLQI in the Open-label Treatment Period|The DLQI was a 10-item questionnaire designed to evaluate the effect of skin conditions (alopecia) on the participants quality of life. Each item was scored on a 4-point scale ranging from 0 to 3 with a maximum score of 30. Higher scores represent greater impairment in quality of life. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value.|Baseline and Upto Week 24|Open-label Period Population|||Scores on a Scale||Standard Deviation|Mean
2613958|NCT02014584|Secondary|Change From Baseline in the Total Score of the Dermatology Life Quality Index (DLQI) in the Double-blind Treatment Period|The DLQI was a 10-item questionnaire designed to evaluate the effect of skin conditions (alopecia) on the participants quality of life. Each item was scored on a 4-point scale ranging from 0 to 3 with a maximum score of 30. Higher scores represent greater impairment in quality of life. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 12 and Week 24|Safety Population|||Scores on a Scale||Standard Error|Least Squares Mean
2613959|NCT02014584|Secondary|Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the HGSS in the Open-label Treatment Period|The HGSS assessed participants satisfaction with hair appearance and growth by scoring 5 questions on a 7-point scale ranging from 1=very dissatisfied to 7=very satisfied with a maximum score of 35. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value. A decrease from Baseline indicates a worsening. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-label Period Population|||Scores on a Scale||Standard Deviation|Mean
2613960|NCT02014584|Secondary|Change From Baseline in Participant Satisfaction With Hair Growth as Assessed by the Total Score of the Hair Growth Satisfaction Scale (HGSS) in the Double-blind Treatment Period|The HGSS assessed participants satisfaction with hair appearance and growth by scoring 5 questions on a 7-point scale ranging from 1=very dissatisfied to 7= very satisfied with a maximum score of 35. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. A decrease from Baseline indicates a worsening. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 12 and Week 24|Safety Population|||Scores on a Scale||Standard Error|Least Squares Mean
2613961|NCT02014584|Secondary|Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Open-label Treatment Period|The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The Baseline assessment was defined as the latest assessment on or before the OL treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, Week 12 and Week 24|Open-label Period Population|||Scores on a Scale||Standard Deviation|Mean
2613962|NCT02014584|Secondary|Change From Baseline in the Individual Domain Scores (Erectile Function, Orgasmic Function, Sexual Desire, Intercourse Satisfaction and Overall Sexual Satisfaction) of the IIEF in the Double-blind Treatment Period|The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, Week 12 and Week 24|Safety Population|||Scores on a Scale||Standard Error|Least Squares Mean
2613963|NCT02014584|Secondary|Change From Baseline in Total Score of the IIEF in the Open-label Treatment Period|The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The change from Baseline values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, Week 12 and Week 24|Open-Label Period Population|||Scores on a Scale||Standard Deviation|Mean
2613964|NCT02014584|Secondary|Change From Baseline in Total Score of the IIEF in the Double-blind Treatment Period|The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. Overall score range is 0-75. The erectile function score range is 0-30, intercourse satisfaction score range is 0-15, orgasmic function score range is 0-10, sexual desire score range is 0-10, overall satisfaction score range is 0-10. A decrease from Baseline indicates a worsening. The change from Baseline values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, Week 12 and Week 24|Safety Population|||Scores on a Scale||Standard Error|Least Squares Mean
2613965|NCT02014584|Secondary|Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the IIEF Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Open-label Treatment Period|The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. The erectile function domain of the IIEF (IIEF-EF) includes Questions 1 through 5 and Question 15 (maximum score of 30). A clinically meaningful gradient of severity of erectile dysfunction (ED) has been developed, indicating that a score of greater than 25 represents an individual without ED while men scoring <=25 may be classified as having ED. The values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value.|Baseline, Week 4, Week 12 and Week 24|Open-Label Period Population|||Participants|||Number
2613966|NCT02014584|Secondary|Number of Participants With a Change in Sexual Function Defined as a Negative Change From Baseline in the International Index of Erectile Function (IIEF) Erectile Function Domain (IIEF-EF) Score of >=4 Units in the Double-blind Treatment Period|The IIEF is a validated 15-item questionnaire with individual items of the questionnaire assigned to five separate domains of sexual function (i.e., erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction). The IIEF was employed to assess treatment-related changes in men with erectile dysfunction. The erectile function domain of the IIEF (IIEF-EF) includes Questions 1 through 5 and Question 15 (maximum score of 30). A clinically meaningful gradient of severity of erectile dysfunction (ED) has been developed, indicating that a score of greater than 25 represents an individual without ED while men scoring <=25 may be classified as having ED. The values are presented for Week 4, Week 12 and Week 24. The Baseline assessment was defined as the latest assessment on or before the DB treatment start. Change from Baseline is post-Baseline value minus Baseline value.|Baseline, Week 4, Week 12 and Week 24|Safety Population|||Participants|||Number
2613967|NCT02014584|Secondary|Incidence of Premature Discontinuations in the Open-label Treatment Period|Participants were referred as premature discontinuations if they do not complete the open-label treatment period. The reasons for premature withdrawal were protocol deviation, lost to follow-up and withdrawal of consent by participants.|Week 48|ITT population|||Participants|||Number
2613968|NCT02014584|Secondary|Incidence of Premature Discontinuations in the Double-blind Treatment Period|Participants were referred as premature discontinuations if they do not complete the double-blind period. The reasons for premature withdrawal were protocol deviation, lost to follow-up and withdrawal of consent by participants.|Week 24|ITT population|||Participants|||Number
2613969|NCT02014584|Secondary|Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period: Glucose, Potassium, Sodium and Urea/BUN.|Clinical chemistry parameters included: glucose, potassium, sodium, and urea/BUN at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population|||MMOL/L||Standard Deviation|Mean
2613970|NCT02014584|Secondary|Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)|Clinical chemistry parameters included: glucose, potassium, sodium, and urea/BUN at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population|||MMOL/L||Standard Deviation|Mean
2613971|NCT02014584|Secondary|Change From Baseline in the Clinical Chemistry Parameters in the Open-label Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin.|Clinical chemistry parameters included: creatinine, direct bilirubin, total bilirubin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population|||UMOL/L||Standard Deviation|Mean
2613972|NCT02014584|Secondary|Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Creatinine, Direct Bilirubin and Total Bilirubin|Clinical chemistry parameters included: creatinine, direct bilirubin, total bilirubin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population|||UMOL/L||Standard Deviation|Mean
2613973|NCT02014584|Secondary|Change From Baseline in the Indicated Clinical Chemistry Parameters in the Open-label Treatment Period|Clinical chemistry parameters included: ALT, ALP, AST, and GGT at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population|||IU/L||Standard Deviation|Mean
2613974|NCT02014584|Secondary|Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period|Clinical chemistry parameters included: alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST) and gamma glutamyl transferase (GGT) at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population|||IU/L||Standard Deviation|Mean
2613975|NCT02014584|Secondary|Change From Baseline in Clinical Chemistry Parameters in the Open-label Treatment Period: Albumin and Total Protein|Clinical chemistry parameters included: albumin and total protein at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population|||G/L||Standard Deviation|Mean
2613976|NCT02014584|Secondary|Change From Baseline in the Indicated Clinical Chemistry Parameters in the Double-blind Treatment Period: Albumin and Total Protein|Clinical chemistry parameters included: albumin and total protein at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population|||G/L||Standard Deviation|Mean
2613977|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Red Blood Cell (RBC) Count|Hematology parameter included: RBC at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population|||T/L||Standard Deviation|Mean
2613978|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Red Blood Cell (RBC) Count|Hematology parameter included: RBC at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population|||T/L||Standard Deviation|Mean
2613979|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hemoglobin|Hematology parameters included: hemoglobin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population|||G/L||Standard Deviation|Mean
2613980|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hemoglobin|Hematology parameter included: hemoglobin at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population|||G/L||Standard Deviation|Mean
2613981|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameter in the Open-label Treatment Period: Hematocrit|Hematology parameter included: hematocrit at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population|||Proportion of RBCs||Standard Deviation|Mean
2613982|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameter in the Double-blind Treatment Period: Hematocrit|Hematology parameter included: hematocrit at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population|||Proportion of RBCs||Standard Deviation|Mean
2613983|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameters in the Open-label Treatment Period|Hematology parameters included: platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils, and total neutrophils at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Open-Label Period Population|||Giga per Liter (GI/L)||Standard Deviation|Mean
2613984|NCT02014584|Secondary|Change From Baseline in the Indicated Hematology Parameters in the Double-blind Treatment Period|Hematology parameters included: platelet count, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils and total neutrophils at the indicated time points (Week 24 and final value). The Baseline assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. A final value for each period is defined as the latest post-Baseline value available in the period. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and up to Week 24|Safety Population|||Giga per Liter (GI/L)||Standard Deviation|Mean
2613985|NCT02014584|Secondary|Number of Participants With Frequency of Heart Rate of Clinical Concern in the Open-label Treatment Period|Baseline heart rate assessment was defined as the latest assessment on or before the open-label treatment start. The clinical concern range for heart rate was defined as: (lower: <40, upper: >100).|Baseline and up to Week 24|Open-Label Period Population|||Participants|||Number
2613986|NCT02014584|Secondary|Number of Participants With Frequency of Heart Rate of Clinical Concern in the Double-blind Treatment Period|The Baseline heart rate assessment was defined as the latest assessment on or before the double-blind treatment start. The clinical concern range for heart rate was defined as: (lower: <40, upper: >100).|Baseline and up to Week 24|Safety Population|||Participants|||Number
2613987|NCT02014584|Secondary|Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Open-label Treatment Period|The Baseline blood presssure assessment was defined as the latest assessment on or before the open-label treatment start. The clinical concern range for vital signs was defined as: systolic blood pressure (lower: <80, upper: >165) and diastolic blood pressure: (lower: <40, upper: >105).|Baseline and up to Week 24|Open-Label Period Population|||Participants|||Number
2613988|NCT02014584|Secondary|Number of Participants With Frequency of Systolic and Diastolic Blood Pressure of Clinical Concern in the Double-blind Treatment Period|The Baseline blood presssure assessment was defined as the latest assessment on or before the double-blind treatment start. The clinical concern range for vital signs was defined as: Systolic blood pressure (lower: <80, upper: >165) and diastolic blood pressure: (lower: <40, upper: >105).|Baseline and up to Week 24|Safety Population|||Participants|||Number
2613989|NCT02014584|Secondary|Change From Baseline in Heart Rate in the Open-label Treatment Period|Baseline heart rate assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 12 and Week 24|Open-Label Period Population|||Beats per Minute||Standard Deviation|Mean
2613990|NCT02014584|Secondary|Change From Baseline in Heart Rate in the Double-blind Treatment Period|The Baseline heart rate assessment was defined as the latest assessment on or before the double-blind treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 12 and Week 24|Safety Population|||Beats per Minute||Standard Deviation|Mean
2613991|NCT02014584|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure in the Open-label Treatment Period|Baseline blood presure assessment was defined as the latest assessment on or before the open-label treatment start. Change from Baseline is post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 12 and Week 24|Open-Label Period Population|||mmHg||Standard Deviation|Mean
2614241|NCT02013674|Secondary|Difference in Left Ventricular Regional Myocardial Perfusion|As measured via myocardial mass by CT|Baseline, 12 months|Data were not available to perform the statistical analyses as described in the protocol for this outcome.||||||
2613993|NCT02014584|Secondary|Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Open-label Treatment Period|Assessment of suicidality were done through use of the Columbia Suicide Severity Rating Scale (C-SSRS) for suicidal ideation with the ratings 1 to 5 (1. wish to be dead, 2. Non-specific suicidal thoughts, 3. without intent, 4. with intent but no plan, 5. with plan and intent) and for suicidal behavior with the ratings 6 to 9 (6.Prep acts/behavior, 7.aborted attempt, 8. interrupted attempt and 9. actual attempt). C-SSRS was administered at Day 1, Week 12, Week 24, and the early withdrawal visit if applicable .|24 weeks|Safety Population|||Participants|||Number
2613994|NCT02014584|Secondary|Suicidality Assessment Score by Using the Columbia Suicide Severity Rating Scale (C-SSRS) in the Double-blind Treatment Period|Assessment of suicidality were done through use of the Columbia Suicide Severity Rating Scale (C-SSRS) for suicidal ideation with the ratings 1 to 5 (1. wish to be dead, 2. Non-specific suicidal thoughts, 3..without intent, 4. with intent but no plan, 5. with plan and intent) and for suicidal behavior with the ratings 6 to 9 (6.Prep acts/behavior, 7.aborted attempt, 8. interrupted attempt and 9. actual attempt). C-SSRS was administered at Day 1, Week 12, Week 24, and the early withdrawal visit if applicable .|24 weeks|Safety Population|||Participants|||Number
2613995|NCT02014584|Secondary|Number of Participants With AEs of Special Interest in the Double-blind and Open-label Combined Periods|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan.|48 weeks|Dutasteride DB/OL Combined population|||Participants|||Number
2613996|NCT02014584|Secondary|Number of Participants With AEs of Special Interest in the Open-label Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan.|24 weeks|Open-Label Period Population|||Participants|||Number
2613997|NCT02014584|Secondary|Number of Participants With AEs of Special Interest in the Double-blind Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs of special interest included those of sexual function: breast disorders (breast enlargement and breast tenderness), prostate cancer, cardiovascular events, and possible suicidality-related AEs (PSRAEs). Infrequent AEs of special interest included breast cancer, allergic reactions, depressed mood, hair changes, interference with formation of external genitalia in a male fetus, potential for decreased male fertility, and testicular pain and swelling. Special interest AEs are groups of MedDRA terms which have been defined in the analysis plan.|24 weeks|Safety Population|||Participants|||Number
2613998|NCT02014584|Secondary|Number of Participants With Treatment-related AEs in the Double-blind and Open-label Combined Periods|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibility of being caused by the investigational product or whose classification was missing.|48 weeks|Dutasteride DB/OL Combined population|||Participants|||Number
2613999|NCT02014584|Secondary|Number of Participants With Treatment-related AEs in the Open-label Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibilty of being caused by the investigational product or whose classification was missing.|24 weeks|Open-Label Period Population|||Participants|||Number
2614000|NCT02014584|Secondary|Number of Participants With Treatment-related AEs in the Double-blind Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment related AE included events which the investigator classified as having a reasonable possibilty of being caused by the investigational product or whose classification was missing.|24 weeks|Safety Population|||Participants|||Number
2614001|NCT02014584|Secondary|Number of Participants With AEs, SAEs and PSRAEs in the Double-blind and Open-label Combined Periods|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related.|48 weeks|Dutasteride DB/OL Combined population|||Participants|||Number
2614012|NCT02014584|Primary|Number of Participants With Adverse Events (AE) Related to Sexual Function in the Double-blind Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.|24 weeks|Safety Population: all randomized participants who received at least one dose of study treatment.|||Participants|||Number
2614002|NCT02014584|Secondary|Number of Participants With AEs, SAEs and PSRAEs in the Open-label Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related.|24 weeks|Open-Label Period Population|||Participants|||Number
2614003|NCT02014584|Secondary|Number of Participants With AEs, Serious AEs (SAEs) and Possible Suicidality Related Adverse Events (PSRAEs) in the Double-blind Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment, all events of possible drug-induced liver injury with hyperbilirubinemia, breast cancer in male participants, or spontaneous abortion in female partner of male participant. The PSRAE form was used in this study to collect detailed information on the circumstances of reported AEs which, in the investigator's opinion, were possibly suicidality-related.|24 weeks|Safety Population|||Participants|||Number
2614004|NCT02014584|Secondary|Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.|48 weeks|Dutasteride DB/OL Combined population|||Participants|||Number
2614005|NCT02014584|Secondary|Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Open-label Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.|24 weeks|Open-Label Period Population|||Participants|||Number
2614006|NCT02014584|Secondary|Number of Participants Who Discontinued Study Treatment Due to AEs Related to Sexual Function in the Double-blind Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.|24 weeks|Safety Population|||Participants|||Number
2614007|NCT02014584|Secondary|Duration and Persistence of AEs Related to Sexual Function in the Double-blind and Open-label Combined Periods|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable.|48 weeks|Dutasteride DB/OL Combined population|||Days||Standard Deviation|Mean
2614008|NCT02014584|Secondary|Duration and Persistence of AEs Related to Sexual Function in the Open-label Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable.|24 weeks|Safety Population|||Days||Standard Deviation|Mean
2614009|NCT02014584|Secondary|Duration and Persistence of AEs Related to Sexual Function in the Double-blind Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders. Duration is the total number of non-overlapping days for all events per subject. A duration is censored if there is at least one event with unknown start date or end date, in which case the censored duration is the minimum number of days that a subject has experienced any of these events. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA=not applicable.|24 weeks|Safety Population|||Days||Standard Deviation|Mean
2614010|NCT02014584|Primary|Number of Participants With AE Related to Sexual Function for the Double-blind and Open-label Combined Periods|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs related to sexual function are defined as: altered (decreased) libido, impotence, and ejaculation disorders.|48 weeks|Dutasteride DB/OL Combined: all participants who entered the OL Period and taken Dutasteride in both the DB and the OL periods.|||Participants|||Number
2614013|NCT02014558|Secondary|Renal Clearance (CLr) of Cephalexin in Administered With and Without Gilteritinib|Urine samples were used for pharmacokinetic assessments.|Day -1 and cycle 1 day 15: 0-3 hours, 3-6 hours, 6-24 hours postdose (cephalexin)|The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.|||L/h||Standard Deviation|Mean
2614014|NCT02014558|Secondary|Fraction of Drug Excreted Into Urine in Percentage (%Ae) of Cephalexin Administered With and Without Gilteritinib|Urine samples were used for pharmacokinetic assessments.|Day -1 and cycle 1 day 15: 0-3 hours, 3-6 hours, 6-24 hours postdose (cephalexin)|The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.|||percentage||Standard Deviation|Mean
2614015|NCT02014558|Secondary|Amount of Drug Excreted in Urine (Aelast) of Cephalexin Administered With and Without Gilteritinib|Urine samples were used for pharmacokinetic assessments.|Day -1 and cycle 1 day 15: 0-3 hours, 3-6 hours, 6-24 hours postdose (cephalexin)|The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.|||mg||Standard Deviation|Mean
2614016|NCT02014558|Secondary|Apparent Volume of Distribution During the Terminal Elimination Phase After Single Extravascular Dosing (Vz/F) of Cephalexin Administered With and Without Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)|The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.|||liters||Standard Deviation|Mean
2614017|NCT02014558|Secondary|Apparent Total Systemic Clearance After Single or Multiple Extravascular Dosing (CL/F) of Cephalexin Administered With and Without Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)|The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.|||L/h||Standard Deviation|Mean
2614018|NCT02014558|Secondary|T1/2 of Cephalexin Administered With and Without Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)|The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.|||hours||Standard Deviation|Mean
2614019|NCT02014558|Secondary|Tmax of Cephalexin Administered With and Without Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)|The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.|||hours||Full Range|Median
2614020|NCT02014558|Secondary|AUClast of Cephalexin Administered With and Without Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)|The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.|||ng*h/mL||Standard Deviation|Mean
2614021|NCT02014558|Secondary|Cmax of Cephalexin Administered With and Without Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)|The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.|||ng/mL||Standard Deviation|Mean
2614022|NCT02014558|Secondary|Area Under the Concentration-time Curve From the Time of Dosing Extrapolated to Time Infinity (AUCinf) of Cephalexin Administered With and Without Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Day -1 and cycle 1 day 15: predose, 0.5, 1, 1.5, 2, 3, 4, 6, 24 hours postdose (cephalexin)|The analysis population was the PKAS, with participants administered 200 mg gilteritinib and cephalexin.|||ng*h/mL||Standard Deviation|Mean
2614023|NCT02014558|Secondary|Tmax of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)|The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.|||hours||Full Range|Median
2614024|NCT02014558|Secondary|Tmax of Midazolam Administered With and Without Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)|The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.|||hours||Full Range|Median
2614025|NCT02014558|Secondary|AUClast of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)|The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.|||ng*h/mL||Standard Deviation|Mean
2614026|NCT02014558|Secondary|AUClast of Midazolam Administered With and Without Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)|The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.|||ng*h/mL||Standard Deviation|Mean
2614027|NCT02014558|Secondary|Cmax of 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)|The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.|||ng/mL||Standard Deviation|Mean
2614028|NCT02014558|Secondary|Cmax of Midazolam Administered With and Without Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)|The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.|||ng/mL||Standard Deviation|Mean
2614029|NCT02014558|Secondary|AUC24 of Metabolite 1-Hydroxymidazolam After Administration of Midazolam With and Without Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)|The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.|||ng*h/mL||Standard Deviation|Mean
2614030|NCT02014558|Secondary|AUC24 of Midazolam Administered With and Without Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Day -1 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (midazolam)|The analysis population was the PKAS, with participants administered 300 mg gilteritinib and midazolam.|||ng*h/mL||Standard Deviation|Mean
2614031|NCT02014558|Secondary|Tmax of Gilteritinib in Co-administration With Voriconazole|Plasma samples were used for pharmacokinetic assessments.|Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)|The analysis population was the PKAS, with participants administered 20 mg gilteritinib and voriconazole.|||hours||Full Range|Median
2620535|NCT01954160|Secondary|Left Ventricular End Diastolic Volume|Echo: Left Ventricular End Diastolic Volume|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2614032|NCT02014558|Secondary|AUClast of Gilteritinib in Co-administration With Voriconazole|Plasma samples were used for pharmacokinetic assessments.|Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)|The analysis population was the PKAS, with participants administered 20 mg gilteritinib and voriconazole.|||ng*h/mL||Standard Deviation|Mean
2614033|NCT02014558|Secondary|Cmax of Gilteritinib in Co-administration With Voriconazole|Plasma samples were used for pharmacokinetic assessments.|Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)|The analysis population was the PKAS, with participants administered 20 mg gilteritinib and voriconazole.|||ng/mL||Standard Deviation|Mean
2614034|NCT02014558|Secondary|AUC24 of Gilteritinib in Co-administration With Voriconazole|Plasma samples were used for pharmacokinetic assessments.|Cycle 1 Day 15 and Cycle 2 Day 1: predose, 0.5, 1, 2, 4, 6, 24 hours postdose (gilteritinib)|The analysis population was the PKAS, with participants administered 20 mg gilteritinib and voriconazole.|||ng*h/mL||Standard Deviation|Mean
2614035|NCT02014558|Secondary|Percentage of Participants Who Achieved Transfusion Maintenance|Participants who achieved transfusion maintenance were defined as the number of participants who were transfusion independent at baseline period and still maintained transfusion independent at post-baseline period divided by the total number of participants who were transfusion independent at baseline period.|Baseline (28 days prior to first dose until 28 days after the first dose) and postbaseline (from 29 days after first dose date until last dose date); median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days|The analysis population was the FAS. Participants who were transfusion independent at baseline and had evaluable post-baseline transfusion status were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2614036|NCT02014558|Secondary|Percentage of Participants Who Achieved Transfusion Conversion|Participants who achieved transfusion conversion were defined as the number of participants who were transfusion dependent at baseline period but became transfusion independent at post-baseline period divided by the total number of participants who were transfusion dependent at baseline period. Participants were considered baseline transfusion dependent if there were RBC or platelet transfusions within the baseline period. Participants were considered post-baseline transfusion independent if they were on treatment >=84 days, and if there was one consecutive 56 days without any RBC or platelet transfusion within post-baseline period. If participants were on treatment >28 days but <84 days, and there was no RBC or platelet transfusion within post-baseline period, or on treatment <=28 days, post-baseline transfusion status was not evaluable. Exact 95% confidence interval was estimated using the binomial distribution.|Baseline (28 days prior to first dose until 28 days after the first dose) and postbaseline (from 29 days after first dose date until last dose date); median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days|The analysis population was the FAS. Participants who were transfusion dependent at baseline and had evaluable post-baseline transfusion status were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2614037|NCT02014558|Secondary|Leukemia Free Survival (LFS)|LFS was defined as the time from the date of first CRc until the date of documented relapse or death for participants who achieved CRc. For a participant who was not known to have relapsed or died, LFS was censored on the date of last relapse-free disease assessment date. LFS was calculated using Kaplan-Meier method and therefore data are estimated.|From first dose of study drug up to end of study (median time on study was 157.0 days, minimum of 5 days and maximum of 1320 days)|The analysis population was the FAS. Only participants who achieved CRc were included in the analysis.|||days||95% Confidence Interval|Median
2614038|NCT02014558|Secondary|Event Free Survival (EFS)|"EFS was defined as the time from the date of first dose of study drug until the date of documented relapse, treatment failure or death from any cause, whichever occurred first. For a participant with none of these events, EFS was censored at the date of last relapse-free disease assessment. A participant without post-treatment disease assessment was censored at randomization date. Treatment failure included those participants who discontinued the treatment due to progressive disease or lack of efficacy without a previous response of CR, CRp, CRi or PR. Treatment failure date referred to the start of new anti-leukemia therapy or the last treatment evaluation date when new anti-leukemia therapy date was not available. For participants who were censored, last relapse-free disease assessment date referred to the participant's last disease assessment date. EFS was calculated using Kaplan-Meier method and therefore data are estimated."|From first dose of study drug up to end of study (median time on study was 157.0 days, minimum of 5 days and maximum of 1320 days)|The analysis population was the FAS.|||days||95% Confidence Interval|Median
2614039|NCT02014558|Secondary|Overall Survival (OS)|The time from the date of first dose of study drug until the date of death from any cause. For a participant who was not known to have died by the end of study follow-up, OS was censored at the date of last contact. OS was calculated using Kaplan-Meier method and therefore data are estimated.|From first dose of study drug up to end of study (median time on study was 157.0 days, minimum of 5 days and maximum of 1320 days)|The analysis population was the FAS.|||days||95% Confidence Interval|Median
2614040|NCT02014558|Secondary|Time to Best Response (TTBR)|TTBR was defined as the time from the first dose of study drug until the first disease assessment date when participant achieved best response. TTBR was evaluated in participants who achieved best response of CR, CRp, CRi, or PR.|From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS. Only participants who achieved CR, CRp, CRi, or PR were included in the analysis.|||days||Full Range|Median
2614041|NCT02014558|Secondary|Time to Response (TTR)|TTR was defined as the time from the first dose of study drug until the date of either first CRc or PR. TTR was evaluated for participants who achieved CRc or PR.|From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS. Only participants who achieved CRc or PR were included in the analysis.|||days||Full Range|Median
2614042|NCT02014558|Secondary|Time to CRc (TTCRc)|TTCRc was defined as the time from the first dose of study drug until the date of first CRc. TTCRc was evaluated for participants who achieved CRc.|From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS. Only participants who achieved CRc were included in the analysis.|||days||Full Range|Median
2614043|NCT02014558|Secondary|Time to Best CR/CRh (TTBCRCRh)|TTBCRCRh was defined as the time from the first dose of study drug until the first date that the best response of CR or CRh was achieved. TTBCRCRh was evaluated for participants who achieved CR or CRh. For participants who achieve both CR and CRh, the first CR date was used. TTBCRCRh was calculated only for participants who were FLT3 mutation positive.|From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS. Participants who achieved CR or CRh were included in the analysis.|||days||Full Range|Median
2614044|NCT02014558|Secondary|Time to First CR/CRh (TTFCRCRh)|TTFCRCRh was defined as the time from the first dose of study drug until the date of first either CR or CRh. TTFCRCRh was evaluated for participants who achieved CR or CRh. For participants who achieve both CR and CRh, the first CR date or CRh date, whichever occurs first was used. TTFCRCRh was calculated only for participants who were FLT3 mutation positive.|From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS. Only participants who achieved CR or CRh were included in the analysis.|||days||Full Range|Median
2614045|NCT02014558|Secondary|Time to CRi (TTCRi)|TTCRi was defined as the time from the first dose of study drug until the date of first CRi. TTCRi was evaluated for participants who achieved CRi.|From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS. Only participants who achieved CRi were included in the analysis.|||days||Full Range|Median
2614046|NCT02014558|Secondary|Time to CRp (TTCRp)|TTCRp was defined as the time from the first dose of study drug until the date of first CRp. TTCRp was evaluated for participants who achieved CRp.|From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS. Only participants who achieved CRp were included in the analysis.|||days||Full Range|Median
2614047|NCT02014558|Secondary|Time to CR (TTCR)|TTCR was defined as the time from the first dose of study drug until the date of first CR.|From first dose of study drug up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS. Only participants who achieved CR were included in the analysis.|||days||Full Range|Median
2614048|NCT02014558|Secondary|Duration of Response|Duration of response was defined as the time from the date of either first CRc or PR until the date of documented relapse of any type for participants who achieved CRc or PR. Participants who died without report of relapse were considered non-events and censored at their last relapse-free disease assessment date. Other participants who did not relapse on study are considered non-events and censored at the last relapse-free assessment date. Duration of response was calculated using Kaplan-Meier method and therefore data are estimated.|From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS. Only participants who achieved CRc or PR were included in the analysis.|||days||95% Confidence Interval|Median
2614049|NCT02014558|Secondary|Duration of CR/CRh (DCRCRh)|DCRCRh was defined as the time from the date of first DCRCRh until the date of documented relapse for participants who achieved CR or CRh. For participants who achieved both CR and CRh, the first CR date or CRh date, whichever occurred first, was used. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRCRh was calculated using Kaplan-Meier method and therefore data are estimated. DCRCRh was calculated only for participants who were FLT3 mutation positive.|From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS. Only participants who achieved CR or CRh were included in the analysis.|||days||95% Confidence Interval|Median
2614050|NCT02014558|Secondary|Duration of CRc (DCRc)|DCRc was defined as the time from the date of first CRc until the date of documented relapse for participants who achieved CRc. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRc was calculated using Kaplan-Meier method and therefore data are estimated.|From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS. Only participants who achieved CRc were included in the analysis.|||days||95% Confidence Interval|Median
2614051|NCT02014558|Secondary|Duration of CRh (DCRh)|DCRh was defined as the time from the date of first CRh until the date of documented relapse for participants who achieved CRh but did not have a best response of CR. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRh was calculated using Kaplan-Meier method and therefore data are estimated. DCRh was calculated only for participants who were FLT3 mutation positive.|From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS. Only participants who achieved CRh were included in the analysis.|||days||95% Confidence Interval|Median
2614052|NCT02014558|Secondary|Duration of CRi (DCRi)|DCRi was defined as the time from the date of first CRi until the date of documented relapse for participants who achieved CRi. Participants who died without report of relapse and participants who did not relapse were considered non-events and censored at the last relapse-free disease assessment date. DCRi was calculated using Kaplan-Meier method and therefore data are estimated.|From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS. Only participants who achieved CRi were included in the analysis.|||days||95% Confidence Interval|Median
2614053|NCT02014558|Secondary|Duration of CRp (DCRp)|DCRp was defined as the time from the date of first CRp until the date of documented relapse for participants who achieved CRp. Participants who died without report of relapse were considered non-events and censored at their last relapse-free disease assessment date. Other participants who did not relapse on study were considered non-events and censored at the last relapse-free disease assessment date. DCRp was calculated using Kaplan-Meier method and therefore data are estimated.|From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS. Only participants who achieved CRp were included in the analysis.|||days||95% Confidence Interval|Median
2614054|NCT02014558|Secondary|Duration of CR (DCR)|DCR was defined as the time from the date of first CR until the date of documented relapse for participants who achieved CR. Participants who died without report of relapse were considered non-events and censored at their last relapse-free disease assessment date. Other participants who did not relapse on study were considered non-events and censored at the last relapse-free disease assessment date. DCR was calculated using Kaplan-Meier method and therefore data are estimated.|From date of remission until end of study (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS. Only participants who achieved CR were included in the analysis.|||days||95% Confidence Interval|Median
2614055|NCT02014558|Secondary|Percentage of Participants With Complete Remission and Complete Remission With Partial Hematologic Recovery (CR/CRh)|Participants with CR/CRh were defined as participants who achieved either CR or CRh. Participants with CR had bone marrow regenerating normal hematopoietic cells, achieved a morphologic leukemia-free state, had an ANC > 1 x 10^9/L, platelet count ≥ 100 x 10^9/L, and normal marrow differential with < 5% blasts, had been RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). Also, there had been no presence of Auer rods, no evidence of extramedullary leukemia, and blast counts in peripheral blood had been ≤ 2%. Participants with CRh could not be classified as being in CR and had bone marrow blasts < 5%, partial hematologic recovery ANC >= 0.5 x 10^9/L and platelets >= 50 x 10^9/L. There should not be evidence of extramedullary leukemia. Exact 95% confidence interval was estimated using the binomial distribution. CR/CRh was calculated only for participants who were FLT3 mutation positive.|Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS, with participants who were FLT3 mutation positive.|||percentage of participants||95% Confidence Interval|Number
2614056|NCT02014558|Secondary|Percentage of Participants With Best Response|Best response was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). BR was defined as the best measured response for all visits (in the order of CR, CRp, CRi, and PR) post-treatment. Participants who achieved the best response of CR, CRp, CRi or PR were classified as responders. Participants who did not achieve at least PR were considered as non-responders. Exact 95% confidence interval was estimated using the binomial distribution.|Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS.|||percentage of participants||95% Confidence Interval|Number
2614057|NCT02014558|Secondary|Percentage of Participants With Partial Remission (PR)|PR was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in PR when they had bone marrow regenerating normal hematopoietic cells with evidence of peripheral recovery with no (or only a few regenerating) circulating blasts and with a decrease of at least 50% in the percentage of blasts in the bone marrow aspirate with the total marrow blasts between 5% and 25%. A value of less or equal than 5% blasts was also considered a PR if Auer rods were present. There should be no evidence of extramedullary leukemia. Exact 95% confidence interval was estimated using the binomial distribution.|Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS.|||percentage of participants||95% Confidence Interval|Number
2614058|NCT02014558|Secondary|Percentage of Participants With Composite CR (CRc)|CRc was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRc when they had achieved either CR, complete remission with incomplete platelet recovery (CRp, defined as had achieved CR except for incomplete platelet recovery (< 100 x 10^9/L) or complete remission with incomplete hematologic recovery (CRi, defined as had fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with or without complete platelet recovery; RBC platelet transfusion independence not required). Exact 95% confidence interval was estimated using the binomial distribution.|Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS.|||percentage of participants||95% Confidence Interval|Number
2614059|NCT02014558|Secondary|Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh)|CRh was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRh when they could not be classified as being in CR and had bone marrow blasts < 5% and partial hematologic recovery ANC >= 0.5 x 10^9/L and platelets >= 50 x 10^9/L. There should not be evidence of extramedullary leukemia. Exact 95% confidence interval was estimated using the binomial distribution. CRh was calculated only for participants who were FLT3 mutation positive.|Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS, with participants who were FLT3 mutation positive.|||percentage of participants||95% Confidence Interval|Number
2614078|NCT02014519|Secondary|Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Medication)|Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units). Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on their medication history.|||Participants|||Count of Participants
2620536|NCT01954160|Secondary|Tissue Doppler Indices|Echo: Tissue Doppler indices|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2614060|NCT02014558|Secondary|Percentage of Participants With CR With Incomplete Hematological Recovery (CRi)|CRi was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRi when they fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia < 1 x 10^9/L with or without complete platelet recovery. RBC and platelet transfusion independence were not required. Exact 95% confidence interval was estimated using the binomial distribution.|Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS.|||percentage of participants||95% Confidence Interval|Number
2614061|NCT02014558|Secondary|Percentage of Participants With CR With Incomplete Platelet Recovery (CRp)|CRp was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CRp when they achieved CR except for incomplete platelet recovery (< 100 x 10^9/L). Exact 95% confidence interval was estimated using the binomial distribution.|Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS.|||percentage of participants||95% Confidence Interval|Number
2614062|NCT02014558|Secondary|Percentage of Participants With CR During Treatment|CR was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CR when they had bone marrow regenerating normal hematopoietic cells, achieved a morphologic leukemia-free state, had an absolute neutrophil count (ANC) > 1 x 10^9/L, platelet count ≥ 100 x 10^9/L, normal marrow differential with < 5% blasts, had been red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion), had no presence of Auer rods and no evidence of extramedullary leukemia, and blast counts in peripheral blood had been ≤ 2%. Exact 95% confidence interval was estimated using binomial distribution.|Up to end of treatment (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the FAS.|||percentage of participants||95% Confidence Interval|Number
2614063|NCT02014558|Secondary|Percentage of Participants With Complete Remission (CR) During the First 2 Cycles|CR was defined according to modified Cheson criteria (2003), using centrally evaluated myeloblast counts from bone marrow aspirate/biopsy assessments and centrally evaluated hematology results; if neither central bone marrow aspirate nor biopsy was available, myeloblast was imputed with locally evaluated bone marrow aspirate/biopsy assessments (derived response). Participants were classified as being in CR when they had bone marrow regenerating normal hematopoietic cells, achieved a morphologic leukemia-free state, had an absolute neutrophil count (ANC) > 1 x 10^9/L, platelet count ≥ 100 x 10^9/L, normal marrow differential with < 5% blasts, had been red blood cell (RBC) and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion), had no presence of Auer rods and no evidence of extramedullary leukemia, and blast counts in peripheral blood had been ≤ 2%. Exact 95% confidence interval was estimated using binomial distribution.|During the first 2 cycles (56 days)|Full analysis set (FAS) - consisted of all participants who were enrolled, took at least 1 dose of study drug and who had at least 1 posttreatment data point. Re-enrolled participants and participants from one site due to concerns with this site’s GCP compliance were excluded. Participants were summarized under planned reporting groups in the FAS.|||percentage of participants||95% Confidence Interval|Number
2614064|NCT02014558|Primary|Accumulation Ratio After Multiple Doses of Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose|The analysis population was the PKAS with available data.|||ratio||Standard Deviation|Mean
2614065|NCT02014558|Primary|Terminal Elimination Half-life (t1/2) After Multiple Doses of Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose|The analysis population was the PKAS with available data.|||hours||Standard Deviation|Mean
2614066|NCT02014558|Primary|Time to Observed Cmax (Tmax) After Single and Multiple Doses of Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose|The analysis population was the PKAS with available data.|||hours||Full Range|Median
2614067|NCT02014558|Primary|Area Under the Concentration-time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) After Single and Multiple Doses of Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose|The analysis population was the PKAS with available data.|||ng*h/mL||Standard Deviation|Mean
2614068|NCT02014558|Primary|Maximum Concentration (Cmax) After Single and Multiple Doses of Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose|The analysis population was the PKAS with available data.|||ng/mL||Standard Deviation|Mean
2614069|NCT02014558|Primary|Area Under the Concentration-time Curve Over the 24-Hour Dosing Interval (AUC24) After Single and Multiple Doses of Gilteritinib|Plasma samples were used for pharmacokinetic assessments.|Day -2 and cycle 1 day 15: predose, 0.5, 1, 2, 4, 6, 24 hours postdose|Pharmacokinetics analysis set (PKAS) - consisted of the subset of the SAF for which sufficient plasma concentration data were available to facilitate derivation of at least 1 pharmacokinetic parameter and for whom the time of dosing on the day of sampling was known. Participants with available data were included in the analysis.|||ng*h/mL||Standard Deviation|Mean
2614091|NCT02014519|Secondary|Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Smoking Status)|Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available.|||Participants|||Count of Participants
2614070|NCT02014558|Primary|Number of Participants With Adverse Events (AEs)|Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A treatment-emergent AE (TEAE) was defined as an AE observed after starting administration of the study drug up to 30 days after last dose of study drug (for participants who underwent hematopoietic stem cell transplantation [HSCT]: defined as AEs observed after starting study drug until the last dose before on study HSCT plus 30 days, and AEs that began after resumption of gilteritinib and within 30 days after the last dose of gilteritinib). AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (1-Mild, 2-Moderate, 3-Severe, 4-LifeThreatening, 5-Death).|From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 69.5 days, minimum of 3 days and maximum of 1320 days)|The analysis population was the SAF.|||Participants|||Count of Participants
2614071|NCT02014558|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|To determine the maximum tolerated dose, safety was assessed by DLTs, defined as any grade ≥ 3 non-hematologic or extramedullary toxicity that occurred within 30 days starting with the first dose taken on day -2, and included the first treatment cycle in the dose escalation phase and in the first treatment cycle (28 days) in the dose expansion phase, that was considered to be possibly or probably related to study drug. Exceptions to this were the following: (1) Alopecia, anorexia or fatigue, (2) Grade 3 nausea and/or vomiting if not required tube feeding or total parenteral nutrition, or diarrhea if not required or prolonged hospitalization that was managed to grade ≤ 2 with standard antiemetic or antidiarrheal medications used at prescribed dose within 7 days of onset, (3) Grade 3 fever with neutropenia, with or without infection, (4) Grade 3 infection.|From first dose up to end of cycle 1 (30 days)|The analysis population was the SAF. Only evaluable participants (defined as participants who received at least 80% of the intended dose during cycle 1 [received at least 23 daily doses in escalation phase or 22 daily doses in expansion phase during cycle 1] or participants who developed DLT within cycle 1) were included.|||Participants|||Count of Participants
2614072|NCT02014519|Secondary|Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Hospitalization)|The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units. History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on their hospitalization history.|||Participants|||Count of Participants
2614073|NCT02014519|Secondary|Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Hospitalization)|The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units. History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on their hospitalization history.|||Participants|||Count of Participants
2614074|NCT02014519|Secondary|Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Hospitalization)|Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units). History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on their hospitalization history.|||Participants|||Count of Participants
2614075|NCT02014519|Secondary|Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Hospitalization)|Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units). History of hospitalization was defined as hospitalization due to respiratory infections in the previous 12 months.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on their hospitalization history.|||Participants|||Count of Participants
2614076|NCT02014519|Secondary|Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Medication)|The cut-off value for anti-PT IgG levels indicative of current/recent infection was smaller than (<) 1.0 OD units. Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on their medication history.|||Participants|||Count of Participants
2614077|NCT02014519|Secondary|Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Medication)|The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units. Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on their medication history.|||Participants|||Count of Participants
2614092|NCT02014519|Secondary|Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough)|The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units. A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on recent history of long-lasting cough.|||Participants|||Count of Participants
2614079|NCT02014519|Secondary|Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Medication)|Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units). Medication included any antibiotics and/or other medication (i.e. any cough medicines) for lower respiratory tract infections, Pertussis infections or suspected Pertussis infections in the previous 12 months.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on their medication history.|||Participants|||Count of Participants
2614080|NCT02014519|Secondary|Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis)|The cut-off value for anti-PT IgG levels indicative of current/recent infection was smaller than (<) 1.0 OD units.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on history of vaccination against pertussis.|||Participants|||Count of Participants
2614081|NCT02014519|Secondary|Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Vaccination Against Pertussis)|The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on history of vaccination against pertussis.|||Participants|||Count of Participants
2614082|NCT02014519|Secondary|Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis)|Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on history of vaccination against pertussis.|||Participants|||Count of Participants
2614083|NCT02014519|Secondary|Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Vaccination Against Pertussis)|Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on history of vaccination against pertussis.|||Participants|||Count of Participants
2614084|NCT02014519|Secondary|Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by History of Pertussis)|The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on history of pertussis.|||Participants|||Count of Participants
2614085|NCT02014519|Secondary|Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by History of Pertussis)|The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on history of pertussis.|||Participants|||Count of Participants
2614086|NCT02014519|Secondary|Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)|Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on history of pertussis.|||Participants|||Count of Participants
2614087|NCT02014519|Secondary|Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by History of Pertussis)|Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on history of pertussis.|||Participants|||Count of Participants
2614088|NCT02014519|Secondary|Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Smoking Status)|The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available.|||Participants|||Count of Participants
2614089|NCT02014519|Secondary|Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Smoking Status)|The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available.|||Participants|||Count of Participants
2614090|NCT02014519|Secondary|Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Smoking Status)|Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available.|||Participants|||Count of Participants
2614208|NCT02013830|Secondary|Overall Survival - Percentage of Participants With an Event|Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.|Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.|ITT population.|||percentage of participants|||Number
2614093|NCT02014519|Secondary|Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Recent History of Long-lasting Cough)|The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units. A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on recent history of long-lasting cough.|||Participants|||Count of Participants
2614094|NCT02014519|Secondary|Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough)|Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units). A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on recent history of long-lasting cough.|||Participants|||Count of Participants
2614095|NCT02014519|Secondary|Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Recent History of Long-lasting Cough)|Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units). A long-lasting cough was defined as any cough that lasted for more than (≥) 3 weeks in the previous 12 months.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available and who provided information on recent history of long-lasting cough.|||Participants|||Count of Participants
2614096|NCT02014519|Secondary|Number of Subjects With Anti-PT IgG Levels Not Indicative of Current/Recent Infection (by Gender)|The cut-off value for anti-PT IgG levels not indicative of current/recent infection was smaller than (<) 1.0 OD units.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available.|||Participants|||Count of Participants
2614097|NCT02014519|Secondary|Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Gender)|Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available.|||Participants|||Count of Participants
2614098|NCT02014519|Secondary|Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Gender)|The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available.|||Participants|||Count of Participants
2614099|NCT02014519|Secondary|Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Gender)|The cut-off value for anti-PT IgG levels strongly indicative of current/recent infection was greater than or equal to (≥) 1.5 OD units|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available.|||Participants|||Count of Participants
2614100|NCT02014519|Secondary|Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Gender)|Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units)|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available.|||Participants|||Count of Participants
2614101|NCT02014519|Secondary|Number of Seronegative Subjects in Terms of Anti-PT Concentrations (by Age)|Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available.|||Participants|||Count of Participants
2614102|NCT02014519|Secondary|Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection (by Age)|The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available.|||Participants|||Count of Participants
2614103|NCT02014519|Secondary|Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection (by Age)|The cut-off value for anti-PT IgG levels strongly indicative of current/recent infection was greater than or equal to (≥) 1.5 OD units|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available.|||Participants|||Count of Participants
2614104|NCT02014519|Secondary|Number of Seropositive Subjects in Terms of Anti-PT Concentrations (by Age)|Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 OD units).|At the time of enrollment of each subject (Day 0).|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available.|||Participants|||Count of Participants
2614105|NCT02014519|Primary|Number of Seronegative Subjects in Terms of Anti-PT Concentrations|Seronegativity was defined as anti-PT IgG levels under the sensitivity limit of the assay (≤ 0.3 OD units)|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available.|||Participants|||Count of Participants
2620537|NCT01954160|Secondary|Heart Rate Variability|Heart rate variability indices by Holter|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2614106|NCT02014519|Primary|Number of Subjects With Anti-PT IgG Levels Indicative of Current/Recent Infection|The cut-off value for anti-PT IgG levels indicative of current/recent infection was greater than or equal to (≥) 1.0 OD units.|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available.|||Participants|||Count of Participants
2614107|NCT02014519|Primary|Number of Subjects With Anti-PT IgG Levels Strongly Indicative of Current/Recent Infection|The cut-off value for anti-PT IgG levels strongly indicative of current/recent infection was greater than or equal to (≥) 1.5 OD units|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available.|||Participants|||Count of Participants
2614108|NCT02014519|Primary|Number of Seropositive Subjects in Terms of Anti-pertussis Toxin (Anti-PT) Concentrations|Seropositivity was defined as anti-PT IgG levels above the sensitivity limit of the assay (> 0.3 Optical Density (OD) units)|At the time of enrollment of each subject (Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort included all evaluable subjects for whom valid laboratory test results for anti-pertussis toxin antibodies were available.|||Participants|||Count of Participants
2614109|NCT02014480|Secondary|Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 15 of Each Treatment Period|Trough FEV1 on Treatment Day 15 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 14. Analysis was performed using an ANCOVA model with covariates of treatment, period, mean Baseline (BL), period BL, response type, and treatment by response type interaction. A participant is a reponder to UMEC if they were a responder to UMEC monotherapy or a responder to both UMEC monotherapy and VI monotherapy. A participant is a responder to VI if they were a responder to VI monotherapy or a responder to both UMEC monotherapy or VI monotherapy. BL is the mean FEV1 recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean BL is the mean of the BLs for each participant, and period BL is the difference between BL and the mean BL in each treatment period for each participant. Change from BL for each treatment period is the Day 15 value minus the BL value for that treatment period.|Baseline and Day 15 of each treatment period (up to study day 81)|ITT Population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed for different parameters; the overall number of participants analyzed reflects everyone in the ITT Population.|||Liters||Standard Error|Least Squares Mean
2614110|NCT02014480|Secondary|Number of Participants With a Larger Change From Baseline in 0-6 Hour Weighted Mean FEV1 at Day 14 of Each Treatment Period With UMEC/VI Compared With UMEC and VI Alone|The number of participants with a larger change from Baseline in weighted mean FEV1 with UMEC/VI compared with UMEC and VI alone was recorded. Participants who improved on UMEC/VI had a larger change from Baseline difference in 0-6 hour weighted mean FEV1 on Day 14 on UMEC/VI compared to UMEC or VI alone. Baseline is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the Day 14 value minus the Baseline value for that treatment period.|Baseline and Day 14 of each treatment period (up to study day 85)|ITT Population. Only those participants available at the indicated time point were assessed.|||participants|||Number
2614111|NCT02014480|Secondary|Number of Participants (Par.) Who Were Responsive to UMEC/VI, UMEC or, VI According to FEV1 at Day 1 of Each Treatment Period (TP)|A responder is a par. with an increase from BL of >=12% and 200 milliliters (mL) at >=1 time point over 0-6 hours post-dose (PD) in FEV1 on Day 1. A non-responder (NR) is a par. with >=1 FEV1 assessment over 0-6 hours PD on Day 1 but no increase from BL of >=12% and 200 mL at any assessment(s). Missing: no FEV1 data recorded over 0-6 hours PD on Day 1. Response type is defined based on a par.'s response to each individual monotherapy treatment. A responder to UMEC is a par. who is a responder in the UMEC treatment period (TP) and either a NR or has missing data in the VI TP. A responder to VI is a par. who is a responder in the VI TP and either a NR or has missing data in the UMEC TP. A responder to UMEC and VI is a par. who is a responder in both the UMEC and VI TPs. A responder to neither is a par. who is a NR in both the UMEC and VI TPs. Missing: a par. who has missing data in both the UMEC and VI TPs, or who has missing data in one monotherapy period and is a NR in the other.|Baseline (BL) and 0-6 hours post-dose (15 minutes, 30 minutes, and 1, 3, and 6 hours post-dose) on Day 1 of each treatment period (up to study day 66)|ITT Population|||participants|||Number
2614112|NCT02014480|Primary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour Forced Expiratory Volume in One Second (FEV1) Obtained Post-dose at Day 14 of Each Treatment Period (TP) by Response Type|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM FEV1 was calculated using 0-6 hour post-dose measurements at Day 14 of each TP, which included pre-dose (trough value for Day 14 [mean of the 23 and 24 hour assessments post Day 13 dosing]) and post-dose 15 minutes (min), 30 min, and 1, 3, and 6 hours. BL is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each TP, mean BL is the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the Day 14 value minus the BL value for that TP.|Baseline and Day 14 of each treatment period (up to study day 85)|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received >=1 dose of randomized study medication in a TP. Only par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number of par, analyzed reflects everyone in the ITT Population.|||Liters||Standard Error|Least Squares Mean
2614122|NCT02014467|Secondary|Change From Baseline in Calcium (Corrected), Calcium at Month 1, Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Calcium (corrected) and calcium were assessed at Baseline, Month 1, Month 6 and Month 12.|Baseline, Month 1, Month 6 and Month 12.|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2614113|NCT02014467|Secondary|Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (Non-fatal Serious Adverse Events and Fatal Serious Adverse Events)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, serious non-fatal AEs, serious fatal AEs have been presented.|From start of IP through the Study Phase (6 months post-dose) (assessed up to 12 months)|Safety Population. Two participants randomized to placebo group received denosumab by mistake.|||Participants|||Number
2614114|NCT02014467|Secondary|Number of Participants With Confirmed Anti-denosumab Antibody Formation at Baseline and Month 12|Anti-denosumab antibody formation was assessed at Baseline (Visit 3) and Month 12. Binding antibody and neutralizing antibody assays were used to assess number of participants with anti-denosumab antibody.|Baseline and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
2614115|NCT02014467|Secondary|Change From Baseline in Red Blood Cell Count at Month 6 and Month 12|Baseline value was obtained at screening (visit 2). If missing, the most recent non-missing value was used. Change in baseline value was assessed as: Value at Indicated visit minus Baseline value. Blood samples were collected for measurement. Red blood cell count was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Trillion cells per liter (TI/L)||Standard Deviation|Mean
2614116|NCT02014467|Secondary|Change From Baseline in Mean Corpuscle Volume at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Mean corpuscle volume was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Femtoliter (FL)||Standard Deviation|Mean
2614117|NCT02014467|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Mean corpuscle hemoglobin was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12.|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Picograms (PG)||Standard Deviation|Mean
2614118|NCT02014467|Secondary|Change From Baseline in Hematocrit at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Hematocrit was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12.|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Ratio||Standard Deviation|Mean
2614119|NCT02014467|Secondary|Change From Baseline in Creatinine and Uric Acid at Month 6 and Month 12|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Creatinine and uric acid were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Micromoles per liter (UMOL/L)||Standard Deviation|Mean
2614120|NCT02014467|Secondary|Change From Baseline in Direct Bilirubin, Total Bilirubin at Month 1, Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Direct bilirubin and total bilirubin were assessed at Baseline, Month 1, Month 6 and Month 12.|Baseline, Month 1, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Micromoles per liter (UMOL/L)||Standard Deviation|Mean
2614121|NCT02014467|Secondary|Change From Baseline in Chloride, Cholesterol, Glucose, Magnesium, Inorganic Phosphorous, Potassium, Sodium, Triglycerides, Urea/Blood Urea Nitrogen (BUN) at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Chloride, cholesterol, glucose, magnesium, inorganic phosphorous, potassium, sodium, triglycerides and urea/BUN were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2614193|NCT02014116|Secondary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 28|PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state AUC[0-τ].|Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose|All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 28, per protocol.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2614123|NCT02014467|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils-total Absolute Neutrophil Count (ANC), White Blood Cell Count at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils-total ANC and white blood cell count were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Giga per liter (GI/L)||Standard Deviation|Mean
2614124|NCT02014467|Secondary|Change From Baseline in Hemoglobin and Total Protein at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at indicated visit minus the Baseline value. Blood samples were collected for measurement. Hemoglobin and total protein were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Grams per liter (G/L)||Standard Deviation|Mean
2614125|NCT02014467|Secondary|Change From Baseline in Globulin at Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at indicated visit minus the Baseline value. Blood samples were collected for measurement. Globulin was assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Grams per liter (G/L)||Standard Deviation|Mean
2614126|NCT02014467|Secondary|Change From Baseline in Albumin at Month 1, Month 6 and Month 12.|Baseline value was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Albumin was assessed at Baseline, Month 1, Month 6 and Month 12.|Baseline, Month 1, Month 6 and Month 12.|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Gram per liter (G/L)||Standard Deviation|Mean
2614127|NCT02014467|Secondary|Change From Baseline in Creatine Kinase, Lactate Dehydrogenase at Month 6 and Month 12.|Baseline values was obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Creatine kinase and lactate dehydrogenase were assessed at Baseline, Month 6 and Month 12.|Baseline, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||International unit per liter (IU/L)||Standard Deviation|Mean
2614128|NCT02014467|Secondary|Change From Baseline in Alanine Amino Transferase, Alkaline Phosphatase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Month 1, Month 6 and Month 12|Baseline values were obtained at Screening (Visit 2). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Blood samples were collected for measurement. Alanine amino transferase, alkaline phosphatase, aspartate amino transferase, and gamma glutamyl transferase were assessed at Baseline, Month 1, Month 6 and Month 12.|Baseline, Month 1, Month 6, and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||International unit per liter (IU/L)||Standard Deviation|Mean
2614129|NCT02014467|Secondary|Change From Baseline in Heart Rate at Month 1, Month 3, Month 6, and Month 12|Baseline value was obtained at Randomization (Visit 3). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Change from Baseline in heart rate was assessed at Baseline, Month 1, Month 3, Month 6 and Month 12.|Baseline, Month 1, Month 3, Month 6 and Month 12|Safety Population. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Beats per minute||Standard Deviation|Mean
2614130|NCT02014467|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 1, Month 3, Month 6, and Month 12|Baseline value was obtained at Randomization (Visit 3). If missing, the most recent non-missing value was used. Change in Baseline value was assessed as the value at the indicated visit minus the Baseline value. Change from Baseline in SBP and DBP was assessed at Baseline, Month 1, Month 3, Month 6, and Month 12.|Baseline, Month 1, Month 3, Month 6 and Month 12|Safety Population: all participants who received at least one dose of study medication. Two participants randomized to placebo group received denosumab by mistake. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2614131|NCT02014467|Secondary|Percent Change in Serum Procollagen Type I N Propeptideserum (s-PINP) From Baseline to Month 6 and Month 12|s-PINP is biomarker of bone resorption and formation. s-PINP was assessed during Screening, Month 6 and Month 12 in the Double-blind Treatment Phase. The value during Screening was considered as the Baseline value. Percent change from Baseline was assessed as the value at the indicated visit minus the Baseline value divided by the Baseline value x 100. A two-sided Wilcoxon rank sum test was used to compare percent change in serum CTX. Between group inferences is presented by p-values, Hodges-Lehmann estimates along with 95% confidence intervals.|Baseline, Month 6, Month 12|ITT Population: Only those participants with values at Baseline and Month 6 and Month 12 are included in the analysis (represented by n=X, X in the category titles).|||Percentage change||Inter-Quartile Range|Median
2614236|NCT02013674|Secondary|Creatinine Kinase Muscle/Brain (CK-MB)|CK-MB values in ng/mL over time.|12 hours, 24 hours post cardiac catheterization|Not all participants were able to complete the procedure.|||ng/ml||Full Range|Median
2614132|NCT02014467|Secondary|Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) From Baseline to Month 6 and Month 12|s-CTX is biomarker of bone resorption and formation. s-CTX was assessed during Screening, Month 6 and Month 12 in the Double-blind Treatment Phase. The value during Screening was considered as the Baseline value. Percent change from Baseline was assessed as the value at the indicated visit minus the Baseline value divided by the Baseline value x 100. A two-sided Wilcoxon rank sum test was used to compare percent change in s-CTX. Between group inferences is presented by p-values, Hodges-Lehmann estimates along with 95% confidence intervals.|Baseline, Month 6 and Month 12|ITT Population. Only those participants with values at Baseline and Month 6 and Month 12 are included in the analysis (represented by n=X, X in the category titles).|||Percentage change||Inter-Quartile Range|Median
2614133|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Trochanter at Month 12|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 12|ITT Population. Participants with values at Baseline and Month 12 were included in the analysis.|||Percentage change||Standard Error|Least Squares Mean
2614134|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Femoral Neck at Month 12|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 12|ITT Population. Participants with values at Baseline and Month 12 were included in the analysis.|||Percentage change||Standard Error|Least Squares Mean
2614135|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Total Hip at Month 12|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 12|ITT Population. Participants with values at Baseline and Month 12 were included in the analysis.|||Percentage change||Standard Error|Least Squares Mean
2614136|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Trochanter at Month 6|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 6|ITT Population. Participants with values at Baseline and Month 6 were included in the analysis.|||Percentage change||Standard Error|Least Squares Mean
2614137|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Femoral Neck at Month 6|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 6|ITT Population. Participants with values at Baseline and Month 6 were included in the analysis.|||Percentage change||Standard Error|Least Squares Mean
2614138|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Total Hip at Month 6|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 6|ITT Population. Participants with values at Baseline and Month 6 were included in the analysis.|||Percentage change||Standard Error|Least Squares Mean
2614237|NCT02013674|Secondary|Number of Participants With Abnormal ECHO Reading|The number of participants with abnormal reading post-cardiac catheterization. As assessed per treating physician discretion.|6 hours post cardiac catheterization|Not all participants were able to complete the procedure.|||Participants|||Count of Participants
2614139|NCT02014467|Secondary|Percent Change From Baseline in BMD at the Lumbar Spine at Month 6|BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. ANCOVA model adjusted for treatment, center/region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the LOCF, provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 6|ITT Population. Participants with values at Baseline and Month 6 were included in the analysis.|||Percentage change||Standard Error|Least Squares Mean
2614140|NCT02014467|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine at Month 12|Bone mineral density (BMD) is the amount of bone mineral in bone tissue. BMD scan was done using dual energy x-ray absorptiometry (DXA). It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calcuated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. The analysis was performed by Analysis of Covariance (ANCOVA) model adjusted for treatment, region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as Baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the Last Observation Carried Forward (LOCF), provided the assessment was taken on or after at least one month on-therapy.|Baseline and Month 12|Intent-to-Treat (ITT) Population: all safety Population participants (consisting of all participants who received at least one dose of study medication) who had a Baseline and at least one valid post-Baseline efficacy measure. Participants with values at Baseline and Month 12 were included in the analysis.|||Percentage change||Standard Error|Least Squares Mean
2614141|NCT02014441|Secondary|Number of Participants With Adverse Events (AEs)|"The Common Terminology Criteria for Adverse Events version 3.0 was used to grade severity of adverse events, based on the following general guideline: Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE. A serious adverse event was defined as an adverse event that meets at least 1 of the following serious criteria:~fatal~life threatening~requires in-patient hospitalization or prolongation of existing hospitalization~results in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event~Treatment-related adverse events (TRAEs) are defined as adverse events possibly caused by talimogene laherparepvec, as assessed by the investigator."|From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.|||Participants|||Count of Participants
2614142|NCT02014441|Secondary|Overall Survival|Overall Survival (OS) was defined as the interval from first dose of talimogene laherparepvec to death from any cause; participants still alive were censored at the last known alive date.|From first dose until 60 days after last dose of talimogene laherparepvec; The median actual follow-up time was 28.9 weeks (range: 4 to 151 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.|||months||95% Confidence Interval|Median
2614143|NCT02014441|Secondary|Durable Response Rate|"Response was assessed according to modified World Health Organization (WHO) criteria using both clinical (cutaneous, subcutaneous, or nodal tumor measurement by caliper) and radiological imaging (computed tomography, magnetic resonance imaging or ultrasound of the chest, abdomen, and pelvis and all other sites of disease). Durable response rate is defined as the percentage of participants with a complete response or partial response maintained continuously for at least 6 months (183 days).~Complete response: disappearance of all index and non-index lesions.~Partial Response:≥ 50% reduction in size of all index lesions and any new measurable lesions."|Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to the end of treatment; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.|||percentage of participants||95% Confidence Interval|Number
2614144|NCT02014441|Secondary|Duration of Response|Duration of response (DOR) was calculated only for those participants with an objective response and defined as the longest interval from an initial objective response (complete response or partial response) to disease progression per the modified WHO criteria or death, whichever occurred earlier; otherwise, DOR was censored at the last evaluable tumor assessment for participants who did not die or progress.|Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to the end of treatment; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).|All participants who received at least 1 dose of talimogene laherparepvec and had an objective response.|||months||95% Confidence Interval|Median
2614145|NCT02014441|Secondary|Time to Response|Time to response was defined as the interval from the first dose of talimogene laherparepvec to the first event of complete response or partial response per modified WHO criteria; participants who did not respond were censored at the last evaluable tumor assessment.|Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to the end of treatment; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.|||months||95% Confidence Interval|Median
2614146|NCT02014441|Secondary|Objective Response Rate|"Response was assessed according to modified World Health Organization (WHO) criteria using both clinical (cutaneous, subcutaneous, or nodal tumor measurement by caliper) and radiological imaging (computed tomography, magnetic resonance imaging or ultrasound of the chest, abdomen, and pelvis and all other sites of disease). Objective response rate is defined as the percentage of participants with either a complete response or partial response. Subsequent confirmation was not required.~Complete response: disappearance of all index and non-index lesions.~Partial Response: ≥ 50% reduction in size of all index lesions and any new measurable lesions."|Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to the end of treatment; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.|||percentage of participants||95% Confidence Interval|Number
2614147|NCT02014441|Secondary|Best Overall Response|"Response was assessed according to modified World Health Organization (WHO) criteria using both clinical (cutaneous, subcutaneous, or nodal tumor measurement by caliper) and radiological imaging (computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound of the chest, abdomen, and pelvis and all other sites of disease).~Complete response: disappearance of all index and non-index lesions.~Partial Response: ≥ 50% reduction in size of all index lesions and any new measurable lesions.~Stable disease: Neither sufficient tumor shrinkage of index lesion to qualify for response nor sufficient tumor increase of index lesion to qualify for progressive disease, assessed a minimum interval of 77 days from the first dose of study drug.~Progressive Disease: ≥ 25% increase in size of index lesions or appearance of one or more non-index lesions."|Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to the end of treatment; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).|All participants who received at least 1 dose of talimogene laherparepvec.|||participants|||Number
2614148|NCT02014441|Secondary|Number of Samples With Detectable Talimogene Laherparepvec in Lesions Suspected to be Herpetic in Origin|Any lesion such as a cold sore or vesicle thought to be herpetic in origin was evaluated by the investigator and swabbed if HSV infection was suspected. Quantitative PCR was performed on the swab sample to evaluate whether talimogene laherparepvec DNA was detectable in the sample.|From first dose until 60 days after last dose of talimogene laherparepvec; The median actual follow-up time was 28.9 weeks (range: 4 to 151 weeks).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab sample collected from lesions suspected to be herpetic in origin during the study.|||samples|samples||Number
2614149|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Swabs From the Anogenital Area After the End of Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity.|From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after the end of treatment with a positive qPCR result.||||||
2614150|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Swabs From the Anogenital Area After the End of Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in swabs from the anogenital area after the end of treatment is reported.|From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after the end of treatment.|||percentage of participants|||Number
2614151|NCT02014441|Secondary|Percentage of Samples From the Anogenital Area With Detectable Talimogene Laherparepvec Virus After the End of Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity.|30 toFrom 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks). 60 days after the last dose of talimogene laherparepvec.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after the end of treatment with a positive qPCR result.||||samples||
2614152|NCT02014441|Secondary|Percentage of Samples From the Anogenital Area With Detectable Talimogene Laherparepvec DNA After the End of Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the anogenital area with detectable talimogene laherparepvec DNA after the end of treatment is reported.|From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after end of treatment.|||percentage of samples|samples||Number
2614153|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Oral Mucosa After the End of Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity.|From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment with a positive qPCR result.||||||
2614154|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Oral Mucosa After the End of Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in swabs taken from oral mucosa after the end of treatment is reported.|From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment.|||percentage of participants|||Number
2614155|NCT02014441|Secondary|Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec Virus After the End of Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity.|From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment with a positive qPCR result.||||samples||
2614194|NCT02014116|Secondary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the End of Dosing Interval at Steady State (AUC[0-τ]) of LY3009120 Cycle 1 Day 15|PK: area under the concentration versus time curve from time 0 to the end of the twice daily dosing interval at steady state [AUC0-τ].|Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose|All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 15, per protocol.|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2614156|NCT02014441|Secondary|Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec DNA After the End of Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from oral mucosa with detectable talimogene laherparepvec DNA after the end of treatment is reported.|From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment.|||percentage of samples|samples||Number
2614157|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Swabs From the Anogenital Area During Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus in swabs taken from the anogenital area at any time during treatment is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 50) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment with a positive qPCR result.|||percentage of participants|||Number
2614158|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Swabs From the Anogenital Area During Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in swabs from the anogenital area at any time during treatment is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 50) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment.|||percentage of participants|||Number
2614159|NCT02014441|Secondary|Percentage of Samples With Detectable Talimogene Laherparepvec Virus in Swabs From the Anogenital Area During Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of samples with detectable talimogene laherparepvec virus in swabs taken from the anogenital area at any time during treatment is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 50) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment with a positive qPCR result.|||percentage of samples|samples||Number
2614160|NCT02014441|Secondary|Percentage of Samples From the Anogenital Area With Detectable Talimogene Laherparepvec DNA During Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the anogenital area with detectable talimogene laherparepvec DNA at any time during treatment is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 50) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment.|||percentage of samples|samples||Number
2614161|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Oral Mucosa During Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus in swabs taken from oral mucosa at any time during treatment is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 47) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment with a positive qPCR result.|||percentage of participants|||Number
2614162|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Oral Mucosa During Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA on swabs taken from oral mucosa at any time during treatment is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 47) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment.|||percentage of participants|||Number
2614163|NCT02014441|Secondary|Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec Virus During Treatment|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of samples taken from oral mucosa with detectable talimogene laherparepvec virus at any time during treatment is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 47) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment with a positive qPCR result.|||percentage of samples|samples||Number
2614164|NCT02014441|Secondary|Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec DNA During Treatment|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from oral mucosa with detectable talimogene laherparepvec DNA at any time during treatment is reported.|Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 47) on day 1 (pre-dose), cycle 25 on day 1 (pre-dose) and day 8.|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment.|||percentage of samples|Samples||Number
2614238|NCT02013674|Secondary|Serial Troponin I|Serial Troponin I values in ng/mL over time.|12 hours, 24 hours post cardiac catheterization|Not all participants were able to complete the procedure.|||ng/ml||Full Range|Median
2614165|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus on the Surface of Injected Lesions During the First Three Cycles|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus on swabs taken from the surface of injected lesions at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected with a positive qPCR result.|||percentage of participants|||Number
2614166|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA on the Surface of Injected Lesions During the First Three Cycles|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA swabs taken from the surface of injected lesions at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected.|||percentage of participants|||Number
2614167|NCT02014441|Secondary|Percentage of Samples From the Surface of Injected Lesions With Detectable Talimogene Laherparepvec Virus During the First Three Cycles|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of samples taken from the surface of injected lesions with detectable talimogene laherparepvec virus at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected with a positive qPCR result.|||percentage of samples|samples||Number
2614168|NCT02014441|Secondary|Percentage of Samples From the Surface of Injected Lesions With Detectable Talimogene Laherparepvec DNA During the First Three Cycles|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the surface of injected lesions with detectable talimogene laherparepvec DNA at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected.|||percentage of samples|Samples||Number
2614169|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec Virus on the Exterior of the Occlusive Dressing During the First Three Cycles|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus on the exterior of the occlusive dressing at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing with a detectable qPCR result.|||percentage of participants|||Number
2614170|NCT02014441|Secondary|Percentage of Participants With Detectable Talimogene Laherparepvec DNA on the Exterior of the Occlusive Dressing During the First Three Cycles|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA on the exterior of the occlusive dressing at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing.|||percentage of participants|||Number
2614171|NCT02014441|Secondary|Percentage of Samples With Detectable Talimogene Laherparepvec Virus on the Exterior of the Occlusive Dressing During the First Three Cycles|If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of swab samples from the exterior of the occlusive dressing with detectable talimogene laherparepvec virus at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing with a detectable qPCR result.|||percentage of samples|samples||Number
2614172|NCT02014441|Secondary|Percentage of Samples With Detectable Talimogene Laherparepvec DNA on the Exterior of the Occlusive Dressing During the First Three Cycles|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the exterior of the occlusive dressing with detectable talimogene laherparepvec DNA at any time during cycles 1 to 3 is reported.|Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing.|||percentage of samples|samples||Number
2614173|NCT02014441|Secondary|Percentage of Participants With Clearance of Talimogene Laherparepvec DNA From Urine|A participant was defined as having cleared talimogene laherparepvec if a negative urine sample was obtained following a prior positive test and if there were no subsequent positive tests.|Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants received at least 1 dose of talimogene laherparepvec, had at least 2 post-dose urine samples collected within the same dosing cycle with at least 1 positive talimogene laherparepvec DNA sample and at least 1 subsequent sample at any time during the cycle.|||percentage of participants||95% Confidence Interval|Number
2620538|NCT01954160|Secondary|New York Heart Association (NYHA) Functional Classification||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2614174|NCT02014441|Secondary|Percentage of Participants With Clearance of Talimogene Laherparepvec DNA From Blood|A participant was defined as having cleared talimogene laherparepvec if a negative blood sample was obtained following a prior positive test and if there were no subsequent positive tests.|Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants must have received at least 1 dose of talimogene laherparepvec, had at least 2 post-dose blood samples collected within the same dosing cycle with at least 1 positive talimogene laherparepvec DNA sample and at least 1 subsequent sample at any time during the cycle.|||percentage of participants||95% Confidence Interval|Number
2614175|NCT02014441|Primary|Percentage of Participants With Detectable Talimogene Laherparepvec Deoxyribonucleic Acid (DNA) During the First Three Cycles|Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in blood or urine at any time during cycles 1 to 3 is reported. The first cycle was 21 days in length, and subsequent cycles were 14 days in length.|Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).|Participants who were enrolled, received at least 1 dose of talimogene laherparepvec, and had at least 1 postdose blood/urine sample collected.|||percentage of participants||95% Confidence Interval|Number
2614176|NCT02014402|Secondary|Prevalence of Treatment Failures|Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments or maneuvers at the target bleeding site after the start of treatment|From start of treatment up to surgical closure by layers of the exposed surgical field containing the TBS, a median of 34 minutes|Data are presented for subjects in the Human Thrombin and Bovine Thrombin treatment groups in the mITT population|||percent of subjects|||Number
2614177|NCT02014402|Secondary|Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points|"Cumulative proportion of subjects having achieved hemostasis by each of the following time points:~At 3 minutes following start of study treatment~At 4 minutes following start of study treatment"|From start of treatment until 4 minutes after treatment start|Data are presented for subjects in the Human Thrombin and Bovine Thrombin treatment groups in the mITT population|||percent of subjects achieving hemostasis|||Number
2614178|NCT02014402|Primary|Proportion of Subjects Achieving Hemostasis by Five Minutes After Treatment Start at the TBS|Subjects achieving hemostasis at the target bleeding site by 5 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure|From start of treatment until 5 minutes after treatment start|Data are presented for subjects in the Human Thrombin and Bovine Thrombin treatment groups in the modified intent-to-treat (mITT) population|||percent of subjects achieving hemostasis|||Number
2614179|NCT02014376|Secondary|Participants With Scarring At Week 2, Month 1, Month 2, And Month 3|"In the event of a healed wound, where complete closure was confirmed, the extent of scarring was assessed as Present or Absent at all post-baseline visits (Week 2 and Months 1, 2, and 3)."|Week 2, Month 1, Month 2, and Month 3|Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, had received at least 1 application of study drug, and whose target wounds healed while receiving study drug.|||Participants|||Count of Participants
2614180|NCT02014376|Secondary|Change From Baseline In Pain At Day 7|Pain was assessed at Baseline and Day 7. The presence and intensity of pain was assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Scale for participants 6 months to 3 years of age. For participants aged 4 years and older, the Wong Faces Pain Scale was used. Scores were attributed for each of the 5 categories in the FLACC scale from 0 to 2, which resulted in a total score between 0 and 10. The Wong Faces Pain scale used 1 item to rate pain on a 0 to 10 scale. Higher score values indicated more pain.|Baseline, Day 7|Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug.|||score on a scale||Standard Deviation|Mean
2614181|NCT02014376|Secondary|Participants Experiencing A Change From Baseline In Itching At Day 7|The Itch Man Pruritus Assessment Tool was used to measure the intensity of itching. Itching was assessed and reported at Baseline and Day 7. For participants 6 months to 5 years of age, itching was assessed using the caretaker's response, while in participants 6 years and older, itching was self-reported.|Baseline, Day 7|Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug.|||Participants|||Count of Participants
2614182|NCT02014376|Secondary|Percentage Change From Baseline In Lesional Skin Based On Body Surface Area Index (BSAI) Measurements At Month 3|"The BSAI is a global measure of disease spread with weighting factors. Lesional skin consisted of area(s) that could contain any of the following: blisters, bullae, erosions, ulcerations, scabbing and eschars, as well as areas that are weeping, sloughing, oozing, crusted and denuded. The percentage, ranging from 0% to 100%, of affected body surface area was recorded for each defined body region (head/neck, upper limbs, trunk [includes groin], and lower limbs), multiplied by the weighting factor, and then summed for all body regions to calculate the BSAI. The BSAI affected with blisters and wounds was calculated at baseline and Month 3 to assess the total affected area. Percentage change from baseline was calculated as follows: Percentage change from baseline = 100*(Post-baseline value minus Baseline value) divided by Baseline value. Mean percentage change from baseline in BSAI is reported. Only participants with data available for analysis at the specified time point are presented."|Baseline, Month 3|Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug.|||percentage of BSAI||Standard Deviation|Mean
2614183|NCT02014376|Secondary|Participants With Documented Complete Closure Of The Target Wound Within 2 And 3 Months After Initiation Of Treatment|The ARANZ SilhouetteStar™, a wound imaging, measurement, and documentation system providing accurate wound assessment, was used to measure the target wound at all visits. Information captured included photographic images, quantitative measures, and other target wound assessment data input to the device by the clinician, all obtained with no contact to the participant's skin. Information about the target wound's measurement history was available on this system so that the serial progression of the target wound status could also be calculated and presented.|Baseline to Month 2 and Month 3|Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug.|||Participants|||Count of Participants
2614184|NCT02014376|Primary|Participants With Documented Complete Closure Of The Target Wound Within 1 Month After Initiation Of Treatment|The ARANZ SilhouetteStar™, a wound imaging, measurement, and documentation system providing accurate wound assessment, was used to measure the target wound at all visits. Information captured included photographic images, quantitative measures, and other target wound assessment data input to the device by the clinician, all obtained with no contact to the participant's skin. Information about the target wound's measurement history was available on this system so that the serial progression of the target wound status could also be calculated and presented.|Baseline to 1 Month|Intent-to-treat (ITT) Population: Participants who provided informed consent, had been randomized, and had received at least 1 application of study drug.|||Participants|||Count of Participants
2614185|NCT02014363|Primary|Change From Baseline in Baseline-adjusted (Montgomery-Asberg Depression Scale) MADRS Score at the End of Treatment.|The mean difference in baseline-adjusted MADRS score at the end of treatment in the per protocol population using the last observation carried forward (LOCF) method. MADRS is used to assess the range of symptoms that are most frequently observed in patients with major depression. The MADRS test includes 10 items and uses a 0 to 6 severity scale, with higher scores indicating increasing depressive symptoms. The total MADRS score is derived by adding all the scores from the 10 items, meaning the lowest possible score is 0 and the highest possible is 60.|Baseline (start of randomized treatment) and 8 weeks post start of treatment|Per protocol population (all subjects of the full analysis set for whom no relevant protocol deviations were documented).|||Scores on a scale||Standard Error|Least Squares Mean
2614186|NCT02014272|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities|Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (less than [<] 0.8*lower limit of normal[LLN]); leucocytes (<0.6/ greater than [>] 1.5*limit of reference range [LRR]); platelets (<0.5/>1.75*LRR); neutrophils, lymphocytes (<0.8/>1.2*LRR); eosinophils, basophils, monocytes (>1.2*upper LN [ULN]); bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN); creatinine, urea (>1.3*ULN); fasting glucose (<0.6 />1.5*LRR); uric acid (>1.2*ULN); sodium (<0.95/>1.05*LRR); potassium, calcium, chloride, bicarbonate (<0.9/>1.1*LRR); albumin, total protein (<0.8/>1.2*LRR); creatine kinase (>2.0*ULN); urine red blood cells (RBCs), urine white blood cells (WBCs) (>=20 high-powered field). Total number of participants with any laboratory abnormalities was reported.|Screening up to Day 2 of intervention period 2|Safety analysis set consisted of all participants who received at least 1 dose of study medication. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2614187|NCT02014272|Other Pre-specified|Number of Participants With Clinically Significant Changes in Vital Signs|Criteria for clinical significant change in vital signs: systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg), diastolic BP <50 mmHg, supine and sitting heart rate <40 beats per minute (bpm) or greater than (>) 120 bpm, standing and erect heart rate <40 bpm or >140 bpm. Maximum change from baseline in systolic BP >=30 mmHg, maximum change from baseline in diastolic BP >=20 mmHg. Participants who met the criteria were reported.|Screening up to Day 2 of intervention period 2|Safety analysis set consisted of all participants who received at least 1 dose of study medication.|||participants|||Number
2614188|NCT02014272|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax was reported for rifampicin and isoniazid.|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest.|||hour||Full Range|Median
2614189|NCT02014272|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half life (t1/2) was reported for rifampicin and isoniazid.|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, n=participants in the treatment group who were evaluable for this measure for specified drug of each group with reportable t½ values, respectively.|||hour||Standard Deviation|Mean
2614190|NCT02014272|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) was reported for rifampicin and isoniazid. It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, n=participants in the treatment group who were evaluable for this measure for specified drug of each group with reportable AUC (0 - ∞) values, respectively.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2614191|NCT02014272|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax was reported for rifampicin and isoniazid.|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2614192|NCT02014272|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) was reported for rifampicin and isoniazid.|0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1|Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest.|||(nanogram*hour) per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2614207|NCT02013830|Secondary|Overall Survival|Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive. Median Overall Survival was estimated using the Kaplan-Meier method.|Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.|ITT Population.|||months||95% Confidence Interval|Median
2614195|NCT02014116|Secondary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of LY3009120 Cycle 1 Day 1|PK: area under the concentration versus time curve [0-∞] of LY3009120 after a single oral dose Cycle 1 Day1.|Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose|All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 1, per protocol.|||nanogram times hour/milliliter(ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2614196|NCT02014116|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 28|PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 28.|Cycle 1 Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose|All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 28, per protocol.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2614197|NCT02014116|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) at Steady State of LY3009120 Cycle 1 Day 15|PK: Maximum concentration of LY3009120 during a twice daily dosing interval at steady state, Cycle 1 Day 15.|Cycle 1 Day 15: Predose, 0.5, 1, 2, 4, 6, 8, 10 h post-dose|All participants in Part A who received at least one dose of study drug and have evaluable PK data for Cycle 1, Day 15, per protocol.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2614198|NCT02014116|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3009120 Cycle 1 Day 1|PK: Maximum concentration of LY3009120 after a single oral dose Cycle 1 Day 1.|Cycle 1 Day 1: Predose, 0.5, 1, 2, 4, 6, 8, 10 hours (h) post-dose|All participants in Part A who have received at least one dose of study drug and have evaluable PK data in Cycle 1, Day 1, per protocol.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2614199|NCT02014116|Secondary|Number of Participants With Tumor Response|Number of participants with tumor response using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR is defined as at least a 30% decrease in the sum of diameter of target lesions. SD which is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.|Baseline through progressive disease (Up to 7.36 months)|All participants in Part B who received at least one dose of study drug and had post-baseline tumor assessment.|||participants|||Number
2614200|NCT02014116|Primary|Maximum Tolerated Dose (MTD) of LY3009120|Maximum tolerated dose for the recommended Phase 2 dose (RP2D) of LY3009120 that might be safely administered to participants with advanced and/or metastatic cancer. Dose-limiting toxicity (DLT) is defined as an adverse event (AE) during Cycle 1 (28 days) that was possibly related to the study drug and met 1 of the following criteria: According to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: ≥Grade 3 non-hematological toxicity except nausea/vomiting, diarrhea, or constipation that can be controlled with appropriate care; Grade 3 elevations of ALT and/or AST lasting fewer than 8 days (without evidence of other hepatic injury); Grade 3 rash that resolves or improves to a Grade 2 or less within 7 days; CTCAE Grade 4 hematological toxicity of >5 days duration; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia with bleeding; Grade 3 febrile neutropenia.|Cycle 1 (28 Days)|All participants in Part A who received at least one dose of study drug.|||milligrams (mg)|||Number
2614201|NCT02014051|Other Pre-specified|Maximum Tolerated Dose (MTD)|MTD was investigated with an index of DLT|Up to 18 weeks|||||||Number
2614202|NCT02014051|Secondary|Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must Last at Least 8 Weeks)|"Definition~Hematologic Improvement Erythrocyte (HI-E):~Hgb increase by >= 1.5 g/dL Relevant reduction of units of red blood cell (RBC) transfusions by an absolute number of at least 4 RBC transfusions/8 week compared with the pretreatment transfusion number in the previous 8 week. Only RBC transfusions given for a Hgb of <= 9.0 g/dL pretreatment will count in the RBC transfusion response evaluation~Hematologic Improvement Platelet (HI-P):~Absolute increase of >= 30×10^9/L for patients starting with > 20×10^9/L platelets Increase from < 20×10^9/L to > 20×10^9/L and by at least 100%~Hematologic Improvement Neutrophil (HI-N):~At least 100% increase and an absolute increase > 0.5×10^9/L~Progressive disease / Relapse:~At least 1 of the following:~At least 50% decrement from maximum response levels in granulocytes or platelets Reduction in Hgb by >= 1.5 g/dL Transfusion dependence"|Up to 18 weeks||||participants|||Number
2614203|NCT02014051|Secondary|Hematologic Remission Effect (IWG 2006 Criteria, Responses Sustained >= 4 Weeks)|"Definition~Complete remission (CR) Bone marrow: <= 5% myeloblasts; normal maturation of all cell lines Peripheral blood: Hemoglobin (Hgb) >= 11 g/dL, Platelets >= 100×10^9/L, Neutrophils >= 1.0×10^9/L, Blasts 0%~Partial remission (PR) Same as CR except bone marrow blasts decreased by >= 50% over pretreatment but still > 5%~Marrow CR Bone marrow: <= 5% myeloblasts and decrease by >= 50% over pretreatment Peripheral blood: will be noted in addition to marrow CR~Stable disease Failure to achieve at least PR, but no evidence of progression for > 8 weeks Disease progression~Patients with:~Less than 5% blasts: >= 50% increase in blasts to > 5% blasts 5%-10% blasts: >= 50% increase to > 10% blasts 10%-20% blasts: >= 50% increase to > 20% blasts 20%-30% blasts: >= 50% increase to > 30% blasts~Any of the following:~At least 50% decrement from maximum remission/response in granulocytes or platelets Reduction in Hgb by >= 2 g/dL Transfusion dependence"|Up to 60 weeks||||participants|||Number
2614204|NCT02014051|Primary|Number of Participants Who Experienced Dose-limiting Toxicities (DLTs)|"A DLT was defined as adverse events for which a causal relationship with the investigational drug could not be ruled out and which met the following criteria that occurred by the final observation in Cycle 1. DLTs were also assessed in the Efficacy and Safety Assessment Committee.~Criteria~Grade 3 or higher non-hematologic toxicity. However, nausea, vomiting, diarrhoea, pyrexia, stomatitis, and esophagitis/dysphagia are excluded (Grade 3 nausea, vomiting, diarrhoea, and pyrexia that cannot be controlled with antiemetic, antidiarrheal, or antifebrile agents are regarded as DLTs)~Grade 3 or higher stomatitis, esophagitis, and dysphagia that persist for >= 4 days"|Up to 21 days||||participants|||Number
2614205|NCT02014051|Primary|Adverse Events|Total Number Affected by Any Adverse Event (Details are presented in Adverse Event section)|Up to 18 weeks||||participants|||Number
2614206|NCT02013830|Secondary|Overall Survival - Percentage of Participants Event Free at 12 Months|Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.|Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.|ITT population.|||percentage of participants||95% Confidence Interval|Number
2614209|NCT02013830|Secondary|Time to Disease Progression - Percentage of Participants Progression-free at 12 Months|Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.|Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.|ITT population.|||percentage of participants||95% Confidence Interval|Number
2614210|NCT02013830|Secondary|Time to Disease Progression|Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of their tumor assessment.|Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up|Intent-To-Treat (ITT) Population included all enrolled participants who received at least one dose of study medication.|||months||95% Confidence Interval|Median
2614211|NCT02013830|Secondary|Time to Disease Progression - Percentage of Participants With an Event|Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.|Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up|ITT population.|||percentage of participants|||Number
2614212|NCT02013830|Secondary|Percentage of Participants With Disease Control|The percentage of participants with disease control was based on assessment of confirmed CR, PR, or stable disease (SD) according to RECIST criteria. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as ≥ 30 % decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions. SD was defined as not qualifying for PR or progressive disease.|Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up|PP population.|||percentage of participants||95% Confidence Interval|Number
2614213|NCT02013830|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions.|Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up|Per Protocol (PP) Population included participants who: received greater than or equal to (≥) 1 dose of study medication, ≥6 weeks of treatment (unless excluded for allowed reasons), did not severely violate inclusion/exclusion criteria, had tumor assessment, greater than (>) 50% of first 6 weeks of treatment, and were not replaced.|||percentage of participants||95% Confidence Interval|Number
2614214|NCT02013817|Secondary|Percentage of Participants With Adverse Events (AEs)|AEs were recorded from the date of first medication administration until 28 days after the last trial medication.|Day 1 of Cycles 1, 2, 3, 4, 5, and 6 to 28 days after the last trial medication.|ITT population|||percentage of participants|||Number
2614215|NCT02013817|Secondary|Time to Next Treatment - Time to Event|Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment.|Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months||||days||Standard Deviation|Mean
2614216|NCT02013817|Secondary|Time to Next Treatment - Percentage of Participants With an Event|Time to next treatment was calculated as the number of days from either discontinuation of the study drug or the administration of the last dose, until the participants needed next treatment.|Weeks 1, 5, 9, 12, 13, 17, 21 and 24 and every 8 weeks for 64 Weeks and every 6 months||||percentage of participants|||Number
2614217|NCT02013817|Secondary|Percentage of Participants With the Best Clinical Response by Visit (Clinical + Radiological Assessment)|Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, PR, PRTox, PD, and SD were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). LOCF method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum.|Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)|ITT Population|||percentage of participants||95% Confidence Interval|Number
2614218|NCT02013817|Secondary|Percentage of Participants With the Best Clinical Response by Visit (Clinical Assessment)|Best clinical response was determined according to the NCI clinical evaluation and through radiological assessment. CR, CRi, CRu, partial remission (PR), partial remission with toxicity associated (PRTox), progressive disease (PD), and stable disease (SD) were evaluated. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of CLL with additional CT scan evaluation of lymphadenopathy during the treatment period (Radiological). Response assessment for interim (Week 12), end of induction (Week 24) and at Final Staging (4 weeks after last maintenance dose). Last observation carried forward (LOCF) method was used for missing data. Percentages are based on the number of nonmissing observations within each stratum.|Weeks 12 and 24 and at Final Staging (Week 4 after last maintenance dose)|ITT Population|||percentage of participants||95% Confidence Interval|Number
2620539|NCT01954160|Secondary|Patient Global Assessment||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2614219|NCT02013817|Primary|Percentage of Participants With a Best Clinical Response of Clinical Remission (CR)|Best clinical response was determined according to the National Cancer Institute (NCI) Clinical and Clinical plus (+) Radiological evaluations by central response assessment. Assessment of response was performed according to the NCI revised guidelines for the diagnosis and treatment of chronic lymphocytic lymphoma (CLL) with additional computerized tomography (CT) scan evaluation of lymphadenopathy. Per NCI guidelines, CR requires all of the following criteria at least 2 months after the last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/constitutional symptoms; neutrophils greater than (>)1500 per microliter (/µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 grams per deciliter (g/dL), lymphocytes (LC) (less than) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC.|Weeks 1, 5, 9, 12, 13, 17, 21 and 24|ITT Population|||percentage of participants||95% Confidence Interval|Number
2614220|NCT02013791|Other Pre-specified|Change From Baseline in Corneal Staining Score Using a 6-Point Scale|"Total corneal staining with sodium fluorescein was measured in the study eye using the 6-point Oxford scale [Grade 0: <2 dots (best), Grade 1: ≥2 to ≤10 dots, Grade 2: >10 to ≤32 dots, Grade 3: >32 to ≤100 dots, Grade 4: >100 to ≤316 dots and Grade 5: >316 dots or ulcer/erosion (worst)]. The study eye was defined as the eye that received the dosing level of the treatment received. A negative change from Baseline represents a decrease in staining (improvement).~Corneal Staining Score was originally registered as a Primary endpoint but it is actually an exploratory endpoint."|Baseline (Day 1) to Week 12|Modified Intent-to-treat (mITT) Population included all participant who received study treatment and had Baseline and at least 1 post-baseline assessment. Analyses includes participants who had data at both Baseline and Week 12.|||score on a scale||Standard Deviation|Mean
2614221|NCT02013791|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.|First dose of study drug to up to 24 Weeks|Safety Population included all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2614222|NCT02013778|Primary|Number of Participants With Adverse Events|Adverse Events graded according to the Common Terminology Criteria of Adverse Events (CTCAE) version 4.0|1 year||||Participants|||Count of Participants
2614223|NCT02013765|Primary|Percentage of Participants Progression Free at 12 and 24 Months||Months 12 and 24|FAS|||percentage of participants||95% Confidence Interval|Number
2614224|NCT02013765|Secondary|Percentage of Participants by Best Overall Response to Treatment|Per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal [(short axis less than (<)10 millimeters (mm)]. No new lesions. Partial response (PR) was defined as greater than or equal to (≥)30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD) was defined as not qualifying for CR, PR, or progressive disease (PD).|Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment|FAS|||percentage of participants|||Number
2614225|NCT02013765|Primary|Progression-Free Survival - Time to Event|The median time, in months, from the first study drug treatment to a PFS event.|Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment|FAS|||months||95% Confidence Interval|Median
2614226|NCT02013765|Secondary|Percentage of Participants Surviving at 12 and 24 Months||Months 12 and 24|FAS|||percentage of participants||95% Confidence Interval|Number
2614227|NCT02013765|Secondary|Overall Survival - Time to Event|The median time, in months, from the start of study treatment to an OS event.|Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter|FAS|||months||95% Confidence Interval|Median
2614228|NCT02013765|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the start of study treatment to date of death due to any cause.|Screening, every 4 weeks during treatment (up to 37 weeks), at end of treatment, and every 3 months thereafter|FAS|||percentage of participants|||Number
2614229|NCT02013765|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause.|Screening, every 3 months during treatment (up to 37 weeks), and at end of treatment|FAS|||percentage of participants|||Number
2614230|NCT02013687|Secondary|Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite|Assessment of TRA, as measured by the standard membrane feeding assay (SMFA), showing ≥80% reduction of oocysts in Anopheles mosquito gut in ≥50% of the subjects with Study Day 196 sera (one month after the third vaccination) (Study Day 196) in either the 30 μg or 100 μg dose groups.|196 days||||% TRA||95% Confidence Interval|Mean
2614231|NCT02013687|Secondary|Assessment of Transmission Reducing Activity (TRA) of Malaria Parasite|Assessment of TRA, as measured by the standard membrane feeding assay (SMFA), one month after the second vaccination (Study Day 84) in either the 30 μg or 100 μg dose groups.|84 days||||% TRA||95% Confidence Interval|Mean
2614232|NCT02013687|Secondary|Assessment of Anti-Pfs25 IgG Following the Third Immunization.|Serum anti-Pfs25 antibody IgG titers determined using an ELISA unit assay.|196 days|"In the 30 µg + Alhydrogel group, 15 out of 16 patient samples were analyzed as 1 patient in the group had withdrawn from the study by study day 196. In the 100 µg + Alhydrogel group, 13 out of 16 patient samples were analyzed due to 2 patients in the group withdrawing from the study and an insufficient serum sample from a third patient."|||Antibody Titer||95% Confidence Interval|Geometric Mean
2614233|NCT02013687|Primary|Subjects With Solicited Local Adverse Events||336 days||||Participants|||Count of Participants
2614234|NCT02013687|Primary|Subjects With Solicited Systemic Adverse Events||336 days||||Participants|||Count of Participants
2614235|NCT02013687|Primary|Subjects With at Least One Adverse Event||336 days||||Participants|||Count of Participants
2614248|NCT02013674|Secondary|Difference Between Regional Left Ventricular Function (at the Site of Allogeneic Cell Injections)|As determined by Computed Tomography Scan|Baseline, 12 Months|Data were not available to perform the statistical analyses as described in the protocol for this outcome.||||||
2614249|NCT02013674|Secondary|Echocardiographic-derived Measures of Left Ventricular Function|Left ventricular end diastolic wall thickness as determined by echocardiogram.|6 months, 12 months|Not all participants were able to complete the procedure.|||centimeters (cm)||Inter-Quartile Range|Median
2614250|NCT02013674|Secondary|Minnesota Living With Heart Failure (MLHF) Questionnaire Scores|Minnesota Living with Heart Failure (MLHF) Questionnaire has a total score from 0 to 105. A higher score indicates that participant's heart failure is preventing them from living their life.|Baseline, 3 months, 6 months, 12 months|Not all participants were able to complete procedure.|||score on a scale||Inter-Quartile Range|Median
2614251|NCT02013674|Secondary|Number of Participants With Treatment Emergent Adverse Event (AE)|Incidence of Treatment Emergent Adverse Event defined as any untoward medical occurrence in a patient or clinical investigation subject temporally associated with the use of the study product.|6 months, 12 months|Not all participants were able to complete the study.|||Participants|||Count of Participants
2614252|NCT02013674|Secondary|Number of Incidents of Major Adverse Cardiac Events (MACE).|Incidence of the Major Adverse Cardiac Events (MACE) endpoint, defined as the composite incidence of (1) death, (2) hospitalization for worsening heart failure, or (3) non-fatal recurrent MI.|1 month, 6 months, 12 months post injection.|Not all participants were able to complete study.|||Incidents|||Number
2614253|NCT02013674|Secondary|Changed in New York Heart Association (NYHA) Functional Classification Based on Patient's Self Reported Activity Level.|Changed in NYHA Functional Classification will be evaluated. Worsened: Documented increase in limitation in physical activity. Improved: Documented decrease in limitation in physical activity. Unchanged: No documented change in limitation in physical activity.|Baseline to 3 months, Baseline to 6 months, Baseline to 12 months|Not all participants were able to complete procedure.|||Participants|||Count of Participants
2614254|NCT02013674|Secondary|Six-minute Walk Test.|A test that measures how far a patient can walk in 6 minutes.|Baseline, 3 months, 6 months, 12 months|Not all participants were able to complete procedure.|||Meters||Standard Deviation|Mean
2614255|NCT02013674|Secondary|Peak Oxygen Consumption (VO2)|Peak VO2 assessed via treadmill determination.|Baseline, 6 months, 12 months|Not all participants were able to complete procedure.|||mL/kg/min||Standard Deviation|Mean
2614256|NCT02013674|Secondary|Number of Participant With Reported Tissue Perfusion|Tissue perfusion measured by CT.|6 months, 12 months|Not all participants were able to complete procedure.|||Participants|||Count of Participants
2614257|NCT02013674|Secondary|Infarct Scar Size (ISS)|Determined by delayed contrast enhanced Computed Tomography (CT) Scan|Baseline, 12 months|Not all participants were able to complete procedure.|||Percent of Left Ventricular Mass||Inter-Quartile Range|Median
2614258|NCT02013674|Primary|Number of Participants With Treatment-emergent Serious Adverse Events (SAE).|Incidence (at one month post-catheterization) of any treatment-emergent serious adverse events, defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise).|One month post-catheterization|SAEs are collected for 12 months, however, outcome 1 is only for SAEs during the first month.|||Participants|||Count of Participants
2614259|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Barratt Impulsiveness Scale (BIS) 11-Item|The BIS-11 was a participant-rated scale designed to assess impulsive personality traits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, with higher scores indicating impulsive personality traits. It took 10 to 15 minutes to complete the BIS-11. The BIS-11 was administered at the following visits: Baseline and Week 16/ET.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Units on a scale||Standard Deviation|Mean
2614260|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Money Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chose between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for money is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Money value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||unitless||Standard Deviation|Mean
2614294|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Clinical Global Impression-Severity (CGI-S) Total Score|"The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment.|||Units on a scale||Standard Error|Least Squares Mean
2614261|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Food Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chooses between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for food is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Food value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||unitless||Standard Deviation|Mean
2614262|NCT02013622|Secondary|Change From Baseline to Week 16 in the Mean Number of Impulsive Choices in the Delayed Reward Task (DRT)|Delay discounting was a participant-completed task considered as an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. During a training session, a single button with letter A or B appeared on the screen. The participant had to wait until the letter began to flash, and press the button only once. An amount of money was added to a counter and another single button appeared. During the test session, both buttons with letters A and B appeared on the screen. The participant had to choose one of the letters that remained; the other disappeared. The participant had to wait until the letter began to flash and then press the button again. An amount of money was added to the counter, and both letters appeared again. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). A total score was not calculated for this task.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Number of Impulsive Choices||Standard Deviation|Mean
2614263|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Delay and Probability Discounting Task (DPDT) - Experiential Discounting Task Scores|Delay discounting measures the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ with completion of an Experiential Discounting task (EDT). The participant chose between different amounts of money available at different delays or with different chances (probability to get the money). At the end of the session, one of the choices was selected at random, and the participant received whatever they chose in response of that question (immediate, delayed, or probabilistic amount). Formula for h-value:value = A / (1 + hO) p is probability of reward and O is odds against.The value of h indicates how the value of a reward and the probability of its occurrence decreases. The data are computerized and reflect delay discounting and impulsivity (higher discounting and higher Probability discounting shows greater impulsivity). A total score is not computed for this task.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||unitless||Standard Deviation|Mean
2614264|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Scores|"Delay discounting was a participant-completed task is an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ. Discounting rate is estimated using, k= (A/V)1/D, where k is the discounting rate parameter, V is the immediate reward, A is the higher delayed reward and D is the amount of days to the delayed reward. The MCQ consists of 27 choices between immediate and delayed rewards. The participant chooses repeatedly between 2 hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, would you prefer $27 today or $50 in 21 days?) The answers provide an estimate of the participant's discounting rate; higher discounting rates indicate greater impulsivity. A total score is not computed for all 27 questions."|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||unitless||Standard Deviation|Mean
2614265|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Go/No-Go Task (Mean Reaction Time)|Executive function and working memory were assessed using computer based neuropsychological instruments at Baseline and Week 16/Early Termination (ET). These instruments focused on measuring impulse inhibition.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||milliseconds||Standard Deviation|Mean
2614266|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Go/No-Go Task (P-inhibition Failures)|Executive function and working memory were assessed using computer based neuropsychological instruments at Baseline and Week 16/Early Termination (ET). These instruments focused on measuring impulse inhibition. Proportions of inhibitory failures (p-inhibitory failures) is measured as the proportion of no-go targets in the go-cue condition in which a participant failed to inhibit a response.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||failures||Standard Deviation|Mean
2614331|NCT02013375|Secondary|Overall & Disease-Free Survival|To determine the overall and disease-free survival of patients with sickle cell disease receiving HLA-haploidentical hematopoietic stem cell transplantation with this protocol.|Up to one year post-transplant.|No subjects engrafted||||||
2614267|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score|"The TSQM-14 was a participant-rated scale used to assess subjective satisfaction with medication. The TSQM-14 provided scores on 4 domains: effectiveness (questions 1 to 3) side effects (4 to 8), convenience (9 to 11), and global satisfaction (12 to 14). The effectiveness domain was rated on a 7-point scale from extremely satisfied to extremely dissatisfied. The side effects domain provided an option to skip questions 5 to 8 if the subject provided a negative response to item number 4, ie, As a result of taking this medication, do you currently experience any side effects at all? Scores for each domain were transformed into a final score ranging from 0 to 100, with higher numbers indicating a higher level of satisfaction."|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
2614268|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Pittsburgh Sleep Quality Index (PSQI) Total Score|"The PSQI was a self-rated questionnaire that assessed sleep quality and disturbances over a 1-month time interval. Seven domains were measured: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. The PSQI contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if 1 is available). Only self-rated questions are included in the scoring.The 19 self-rated items are combined to form 7 component scores, each of which has a range of 0 - 3 points. In all cases, a score of 0 indicates no difficulty, while a score of 3 indicates severe difficulty. The 7 component scores are then added to yield 1 global score, with a range of 0 - 21 points, 0 indicating no difficulty and 21 indicating severe difficulties in all areas."|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
2614269|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Specific Levels of Functioning (SLOF) Total Score|The SLOF questionnaire used in this trial consists of 30 items grouped into 4 areas: social functioning, social acceptability, activities, and work skill. The SLOF scale correlates with a participant's quality of life. Total SLOF scale is sum of these 4 areas score. Each of the questions in the above domains is rated on a 5-point Likert scale. Scores on the instrument range from 30 to 150 with higher scores indicating the better the overall functioning of the patient.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
2614270|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Personal and Social Performance (PSP) Total Score|The PSP was used to measure personal and social functioning in 4 domains: socially useful activities (e.g., work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the study physician's judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees, and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
2614271|NCT02013622|Secondary|CGI-I Response Rate|The CGI-I response rate was defined as percentage of participants with CGI-I score of 1 (very much improved) or 2 (much improved).|Weeks 4, 8, 12, and 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||percentage of participants|||Number
2614272|NCT02013622|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Score|"The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: Compared to his/her condition at baseline, how much has the participant changed? Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication."|Week 1 to Week 16|All participants who took one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment, the last observation carried forward (LOCF) dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Units on a scale||Standard Deviation|Mean
2614273|NCT02013622|Secondary|Mean Change From Baseline to Week 16 in Clinical Global Impression-Severity (CGI-S) Score|"The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
2614274|NCT02013622|Secondary|Mean Change From Baseline to Week 16 Scores of the Following Negative Scale Items: Active Social Avoidance, Emotional Withdrawal, Passive/Apathetic Social Withdrawal, and Difficulty in Abstract Thinking|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
2614275|NCT02013622|Primary|Mean Change From Baseline to Week 16 in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline and Week 16|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The observed case (OC) data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
2614276|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Barratt Impulsiveness Scale 11-Item (BIS-11) Total Score|The BIS-11 was a participant-rated scale designed to assess impulsive personality traits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, with higher scores indicating impulsive personality traits.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
2614277|NCT02013609|Secondary|Mean Change From Baseline in Money Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chose between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for money is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Money value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.|||unitless||Standard Deviation|Mean
2614278|NCT02013609|Secondary|Mean Change From Baseline in Food Delay Discounting Task (DDT)|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chooses between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for food is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Food value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.|||unitless||Standard Deviation|Mean
2614279|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Delay and Probability Discounting Task (DPDT)|The experiential discounting task (EDT) was a subject-completed computerized task designed to measure delay discounting, an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The participant chose between different amounts of money available at different delays or with different chances (probability to get the money). At the end of the session, one of the choices was selected at random, and the participant received whatever they chose in response of that question (immediate, delayed, or probabilistic amount). Formula for h-value:value = A / (1 + hO) p is probability of reward and O is odds against.The value of h indicates how the value of a reward and the probability of its occurrence decreases.The data are computerized and reflect delay discounting and impulsivity (higher discounting and higher probability discounting shows greater impulsivity). A total score is not computed for this task.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.|||unitless||Standard Deviation|Mean
2614280|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in the Number of Impulsive Choices in the Delayed Reward Task (DRT)|Delay discounting was a participant-completed task considered as an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. During a training session, a single button with letter A or B appeared on the screen. The participant had to wait until the letter began to flash, and press the button only once. An amount of money was added to a counter and another single button appeared. During the test session, both buttons with letters A and B appeared on the screen. The participant had to choose one of the letters that remained; the other disappeared. The participant had to wait until the letter began to flash and then press the button again. An amount of money was added to the counter, and both letters appeared again. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). A total score was not calculated for this task.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.|||Number of Impulsive Choices||Standard Deviation|Mean
2614281|NCT02013609|Secondary|Mean Change From Baseline in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) k Value|"Delay discounting was a participant-completed task is an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ. Discounting rate is estimated using, k= (A/V)1/D, where k is the discounting rate parameter, V is the immediate reward, A is the higher delayed reward and D is the amount of days to the delayed reward. The MCQ consists of 27 choices between immediate and delayed rewards. The participant chooses repeatedly between 2 hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, would you prefer $27 today or $50 in 21 days?) The answers provide an estimate of the participant's discounting rate; higher discounting rates indicate greater impulsivity. A total score is not computed for all 27 questions."|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.|||unitless||Standard Deviation|Mean
2614282|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Go/No-Go Task (Mean Reaction Time)|Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. These instruments focused on measuring impulse inhibition.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.|||milliseconds||Standard Deviation|Mean
2614283|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Go/No-Go Task (P-inhibition Failure)|Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. These instruments focused on measuring impulse inhibition. Proportions of inhibitory failures (p-inhibitory failures) is measured as the proportion of no-go targets in the go-cue condition in which a participant failed to inhibit a response.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.|||failures||Standard Deviation|Mean
2614284|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Kellner Symptom Questionnaire (KSQ) Total Score|KSQ is a subject-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility and somatization. The questionnaire contains 92 items of which 68 items indicate symptoms and 24 items are antonyms of some of the symptoms that indicate well-being. The maximum score for each symptom subscale is 17, the well-being subscales 6 and for the total scale scores 23.The total subscale scores will be unevaluable if less than 19 of the 23 items are recorded. If 19 to 22 of the 23 items are recorded, the total subscale score is the mean of the recorded items multiplied by 23 and then rounded to the first decimal place. The total score will be unevaluable if less than 76 of the 92 items are recorded. If 76 to 91 of the 92 items and no less than 19 of the 23 items of each subscale are recorded, the total score will be the mean of the recorded items multiplied by 92 and then rounded to the first decimal place. A higher score indicates more distress than a lower score.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
2614285|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Massachusetts General Hospital-Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score|The MGH-CPFQ was a participant-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The MGH-CPFQ consisted of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranged from 7 to 42.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
2614295|NCT02013609|Primary|Mean Change From Baseline to Week 12 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score|"The MADRS was utilized as the primary efficacy assessment of the participant's level of depression and was administered utilizing the Structured Interview Guide for the MADRS (SIGMA). Detailed instructions for administration of this structured interview was provided in the SIGMA. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60."|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment.|||Units on a scale||Standard Error|Least Squares Mean
2614286|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Social Adaptation Self-evaluation Scale (SASS) Total Score|The SASS was a self-rated instrument to assess the social motivation and behavior in participants with depression. It contained 21 items covering the different aspects of social interactions, global social attitude, and self-perception. The SASS total score will be un-evaluable if less than 16 of the 20 items (for item number 1 and item number 2, participant is to answer either one of these) are recorded. If 16 to 19 of the 20 items are recorded, the SASS total score will be the mean of the recorded items multiplied by 20 and then rounded to the first decimal place.Each item is scored from 0 to 3, corresponding to minimal and maximal social adjustment, with a total score range of 0 to 60 (higher scores, indicating worse outcome).|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
2614287|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Sheehan Disability Scale (SDS) Single Item Sub-scores|The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0 = not at all to 10 = extremely. Scores of 5 and above were associated with significant functional impairment.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
2614288|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Sheehan Disability Scale (SDS) 3-item Total/Summed Score|The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0 = not at all to 10 = extremely. Scores of 5 and above were associated with significant functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
2614289|NCT02013609|Secondary|Mean Change From Baseline to Week 12 in Hamilton Depression Rating Scale (HAM-D17) Total Score|The HAM-D17 was utilized as an assessment of a participants level of depression and was administered utilizing the Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D). Detailed instructions for administration of this structured interview were provided in the SIGH-D. HAM-D17 is a 17-item questionnaire with a total score of 0 to 52 with higher scores indicating more depressive symptoms.|Baseline and Week 12|All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. Mixed model repeated measures was performed on the OC dataset.|||Units on a scale||Standard Error|Least Squares Mean
2614290|NCT02013609|Secondary|Percentage of Participants With MADRS Remission|MADRS remission rate, where remission is defined as MADRS Total Score ≤ 10 and 50% reduction in MADRS Total Score from Baseline to Week 12.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.|||percentage of participants|||Number
2614291|NCT02013609|Secondary|Percentage of Participants With MADRS Response|MADRS response rate was defined as ≥ 50% reduction in respective total scores from Baseline to Week 12.|Baseline and Week 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, data was carried forward from the previous scheduled treatment phase visit, if no observation was recorded at that visit.|||percentage of particpants|||Number
2614292|NCT02013609|Secondary|Number of Participants With CGI-I Response|The CGI-I response rate was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Weeks 1, 2, 3, 4, 6, 8 ,10 and 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment; the last-observation-carried-forward (LOCF) dataset included data recorded at a scheduled visit or, data was carried forward from the previous scheduled visit, if no observation was recorded at that visit|||participants|||Number
2614293|NCT02013609|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Score at Week 12|"The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: Compared to his/her condition at baseline, how much has the participant changed? Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication."|Weeks 1, 2, 3, 4, 5, 6, 8, 10 and 12|Participants who took at least 1 dose of brexpiprazole with a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment; the last-observation-carried-forward (LOCF) dataset included data recorded at a scheduled visit or, data was carried forward from the previous scheduled visit, if no observation was recorded at that visit|||Units on a scale||Standard Deviation|Mean
2614326|NCT02013388|Primary|Pharmacokinetics: Day 1 Plasma Cmax Values|All subjects who completed sample collections for Day 1 plasma N91115|Day 1|All subjects that completed the plasma collection sampling were included in the analysis|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2614327|NCT02013388|Primary|Pharmacokinetics: AUCtau Day 14|Plasma analysis of AUCtau values from the end of the dosing period (Day 14) with N91115|Day 14|All patients that completed the required days of dosing to study end|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2614296|NCT02013544|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
2614297|NCT02013544|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
2614298|NCT02013544|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
2614299|NCT02013544|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
2614300|NCT02013544|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Dryness|The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of vaginal dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses on vaginal dryness were performed on a sub-group of the Intent to Treat (ITT) population (defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria) who had self-identified moderate to severe vaginal dryness at Baseline.|||units on a scale||Standard Error|Mean
2614301|NCT02013544|Primary|Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia|The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
2614302|NCT02013544|Primary|Change From Baseline to Week 12 in Vaginal pH|A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||units on a scale||Standard Error|Mean
2614303|NCT02013544|Primary|Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear|The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||Percentage of parabasal cells||Standard Error|Mean
2614304|NCT02013544|Primary|Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear|The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||Percentage of superficial cells||Standard Error|Mean
2614328|NCT02013388|Primary|Pharmacokinetics: Day 1 AUClast|Day 1 AUClast plasma values from treatment groups completing 14 days of N91115 administration|Day 1|All patients that had plasma samples collected were included in the analysis|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2614305|NCT02013531|Secondary|Mean Change From Baseline in Barratt Impulsiveness Scale 11-item (BIS-11) Total Score|The BIS-11 was a participant-rated scale designed to assess impulsive personality traits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, with higher scores indicating impulsive personality traits. The BIS-11 was administered at the following visits: Baseline and Week 6/ET.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Units on a scale||Standard Deviation|Mean
2614306|NCT02013531|Secondary|Mean Change From Baseline in Money Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chose between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for money is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Money value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||unitless||Standard Deviation|Mean
2614307|NCT02013531|Secondary|Mean Change From Baseline in Food Delay Discounting Task|"Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chooses between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for food is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the X-axis is days, Y-axis is Food value, the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 −x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting)."|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||unitless||Standard Deviation|Mean
2614308|NCT02013531|Secondary|Mean Change From Baseline to Week 6 in the Number of Impulsive Choices in the Delayed Reward Task (DRT)|Delay discounting was a participant-completed task considered as an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. During a training session, a single button with letter A or B appeared on the screen. The participant had to wait until the letter began to flash, and press the button only once. An amount of money was added to a counter and another single button appeared. During the test session, both buttons with letters A and B appeared on the screen. The participant had to choose one of the letters that remained; the other disappeared. The participant had to wait until the letter began to flash and then press the button again. An amount of money was added to the counter, and both letters appeared again. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). A total score was not calculated for this task.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Number of Impulsive Choices||Standard Deviation|Mean
2614309|NCT02013531|Secondary|Mean Change From Baseline in Delay and Probability Discounting Task (DPDT) Scores|The experiential discounting task (EDT) was a subject-completed computerized task designed to measure delay discounting, an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The participant chose between different amounts of money available at different delays or with different chances (probability to get the money). At the end of the session, one of the choices was selected at random, and the participant received whatever they chose in response of that question (immediate, delayed, or probabilistic amount). Formula for h-value: value = A / (1 + hO) p is probability of reward and O is odds against. The value of h indicates how the value of a reward and the probability of its occurrence decreases. The data are computerized and reflect delay discounting and impulsivity (higher discounting and higher probability discounting shows greater impulsivity). A total score is not computed for this task.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||unitless||Standard Deviation|Mean
2614329|NCT02013388|Primary|Safety and Tolerability of N91115|Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.|21 Days|All patients enrolled in the study were evaluated for safety endpoints|||participants|||Number
2614330|NCT02013375|Secondary|Morbidity & Mortality|To determine the incidence of acute and chronic graft-versus-host disease, the incidence of infectious complications, and the transplant related mortality in sickle cell disease patients after HLA-haploidentical hematopoietic stem cell transplantation with this protocol.|Up to one year post-transplant.|0 subjects engrafted||||||
2614310|NCT02013531|Secondary|Mean Change From Baseline in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Score|"Delay discounting was a participant-completed task is an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ. Discounting rate is estimated using, k= (A/V)1/D, where k is the discounting rate parameter, V is the immediate reward, A is the higher delayed reward and D is the amount of days to the delayed reward. The MCQ consists of 27 choices between immediate and delayed rewards. The participant chooses repeatedly between 2 hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, would you prefer $27 today or $50 in 21 days?) The answers provide an estimate of the participant's discounting rate; higher discounting rates indicate greater impulsivity. A total score is not computed for all 27 questions."|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||unitless||Standard Deviation|Mean
2614311|NCT02013531|Secondary|Mean Change From Baseline in Go/No-Go Task for Mean Reaction Time|Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. These instruments focused on measuring impulse inhibition. The instrument was administered at the following visits: Baseline and Week 6/ET.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||milliseconds||Standard Deviation|Mean
2614312|NCT02013531|Secondary|Mean Change From Baseline in Go/No-Go Task for P-inhibition Failures|Executive function and working memory were assessed for the Go/No-go Task using computer-based and paper-pencil neuropsychological instruments. These instruments focused on measuring impulse inhibition. The instrument was administered at the following visits: Baseline and Week 6/ET.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||failures||Standard Deviation|Mean
2614313|NCT02013531|Secondary|Mean Change From Baseline in Kellner Symptom Questionnaire (KSQ)|KSQ is a subject-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility and somatization. The questionnaire contains 92 items of which 68 items indicate symptoms and 24 items are antonyms of some of the symptoms that indicate well-being. The maximum score for each symptom subscale is 17, the well-being subscales 6 and for the total scale scores 23. A higher score indicates more distress than a lower score. The total subscale scores will be unevaluable if less than 19 of the 23 items are recorded. If 19 to 22 of the 23 items are recorded, the total subscale score is the mean of the recorded items multiplied by 23 and then rounded to the first decimal place. The total score will be unevaluable if less than 76 of the 92 items are recorded. If 76 to 91 of the 92 items and no less than 19 of the 23 items of each subscale are recorded, the total score will be the mean of the recorded items multiplied by 92 and then rounded to the first decimal place.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Units on a scale||Standard Deviation|Mean
2614314|NCT02013531|Secondary|Mean Change From Baseline in Massachusetts General Hospital-Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score|The MGH-CPFQ was a participant-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The MGH-CPFQ consisted of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranged from 7 to 42, with higher scores indicative of a worse outcome. The MGH-CPFQ was administered at the following visits: Baseline and Week 6/ET.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Units on a scale||Standard Deviation|Mean
2614315|NCT02013531|Secondary|Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score|The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0 = not at all to 10 = extremely. Scores of 5 and above were associated with significant functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired).|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Units on a scale||Standard Deviation|Mean
2614316|NCT02013531|Secondary|Mean Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score|The HAM-A was utilized for the evaluation of anxiety symptoms and was administered using the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). Detailed instructions for administration of this structured interview were provided in the SIGH-A. The HAM-A was administered at the following visits: screening, Baseline, Weeks 1, 2, 3, 4, and 6/ET. HAM-A is a 14-item scale with each item is scored on a scale from 0 (not present) to 4 (very severe) with a total score of 0 to 56, with higher scores indicating severe anxiety symptoms.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. A MMRM analysis was performed.|||Units on a scale||Standard Error|Least Squares Mean
2614836|NCT02006758|Secondary|Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months||Baseline and 6 months|48 out of 67 analyzed for renal function change based on eGFR at 6 months.|||mL/min per 1.73 m^2||Standard Deviation|Mean
2614317|NCT02013531|Secondary|Mean Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score|The HAM-D17 was utilized as an assessment of a participants level of depression and was administered utilizing the Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D). Detailed instructions for administration of this structured interview were provided in the SIGH-D. The HAM-D17 was administered at the following visits: screening, Baseline, and Week 6/ Early termination (ET). HAM-D17 is a 17-item questionnaire with a total score of 0 to 52 with higher scores indicating more depressive symptoms.|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Units on a scale||Standard Deviation|Mean
2614318|NCT02013531|Secondary|Percentage of Participants With a MADRS Remission|"MADRS remission rate, where remission is defined as MADRS Total Score ≤ 10 and 50% reduction in MADRS Total Score from Baseline to Week 6. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60, higher values indicate worse outcome."|Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Percentage of participants|||Number
2614319|NCT02013531|Secondary|Percentage of Participants With a MADRS Response|"MADRS response rate, where response is defined as ≥ 50% reduction in respective total scores from Baseline to Week 6. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60, higher values indicate worse outcome."|Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Percentage of participants|||Number
2614320|NCT02013531|Secondary|Percentage of Participants With CGI-I Response Rate|"The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: Compared to his/her condition at baseline, how much has the participant changed? Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication."|Week 1 to Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||percentage of participants|||Number
2614321|NCT02013531|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Score at Week 6.|"The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: Compared to his/her condition at baseline, how much has the participant changed? Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication."|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. The LOCF data set included data recorded at a scheduled treatment phase visit or, if no observation is recorded at that visit, data carried forward from the previous scheduled treatment phase visit.|||Units on a scale||Standard Deviation|Mean
2614322|NCT02013531|Secondary|Mean Change in Clinical Global Impression-Severity (CGI-S) Total Score|"The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid baseline assessment and Post-Baseline efficacy assessment. A MMRM analysis was performed.|||Units on a scale||Standard Error|Least Squares Mean
2614323|NCT02013531|Primary|Mean Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|"The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60, with higher values indicating worse outcome."|Baseline, Week 6|Participants took at least 1 dose of brexpiprazole and who had a valid Baseline and Post-Baseline efficacy assessment. A mixed model repeated measures (MMRM) analysis was performed.|||Units on a scale||Standard Error|Least Squares Mean
2614324|NCT02013414|Primary|Cancer Detection by Targeted and Standard Biopsy Approaches|The feasibility of detecting cancer detection with the targeted prostate biopsy was assessed. This study sought only to determine if the targeted biopsy approach was able to detect recurrent prostate cancer and values for the number of samples testing positive for cancer per each biopsy approach are not available. This feasibility study preceded a clinical trial (NCT02744534) assessing the accuracy of prostate cancer detection with targeted biopsies compared to the standard biopsy.|Up to 2 years|Only whether or not the targeted biopsy could detect cancer was examined and the number of positive biopsy cores per each biopsy approach were not determined.||||||
2614325|NCT02013388|Primary|Pharmacokinetics: Plasma Cmax Values on Day 14|Plasma Cmax values from Day 14 subjects with repeat administration of N91115|Day 14|All subjects completing plasma collection sampling for N91115|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2614332|NCT02013375|Secondary|Acute & Chronic Complications|To assess the frequency of acute and chronic complications of sickle cell disease during and after HLA-haploidentical hematopoietic stem cell transplantation with this protocol. The acute complications include vaso-occlusive pain episodes, acute chest syndrome, stroke, and priapism. The chronic complications include nephropathy, retinopathy, osteonecrosis, pulmonary artery pressures, cardiomyopathy, and chronic lung disease.|Up to one year post-transplant|No subjects engrafted||||||
2614333|NCT02013375|Primary|Engraftment Rate|To determine the engraftment at Day +60 following HLA-haploidentical hematopoietic stem cell transplant protocol using immunosuppressive agents and low-dose total body irradiation (TBI) for conditioning and post-transplant cyclophosphamide in patients with sickle cell disease.|Up to Day 60 post-transplant.||||Participants|||Count of Participants
2614334|NCT02013245|Secondary|Number of Participants With Three-cytokine-positive CD4+ T-cell Response|Measure of the kinetics of CD4+ T-cell responses to MTBVAC or BCG vaccination by tracking the expression of IFNγ, TNFα and IL-2 upon stimulation with live MTBVAC or BCG|Day 28|Number of Participants with Three-cytokine-positive CD4+ T-cell Response (per protocol analysis)|||participants|||Number
2614335|NCT02013245|Primary|Number of Participants With Adverse Events up to 210 Days After Vaccination|"Safety and reactogenicity for all subjects as determined by:~Occurrence of solicited symptoms during the 7-day follow-up period following vaccination and occurrence of unsolicited symptoms during the 210-day follow-up period following vaccination.~Occurrence of grade 3 vaccine related local and general symptoms during the 210-day follow-up period following vaccination and occurrence of serious adverse events throughout the entire study period.~Haematological and biochemical safety test levels prior and after vaccination"|7 months follow up||||participants|||Number
2614336|NCT02013206|Secondary|Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|Up to 2 years|Safety Population included all registered participant who received at least one study treatment and had at least one safety follow-up.|||participants|||Number
2614337|NCT02013206|Secondary|Overall Survival|Overall survival was defined as the time in months from the start of treatment to the date of death irrespective of the cause of death.|Up to 2 years|Safety Population included all participants with at least one study treatment and had at least one safety follow-up. Patients who had not died at the time of the final analysis were censored at the date of last contact.|||months||95% Confidence Interval|Median
2614338|NCT02013206|Secondary|Progression-Free Survival|Progression-Free Survival (PFS) was defined as the time in months from the start of treatment until the first date criteria for Progressive Disease (PD) were met (taking as reference the smallest measurements recorded since the treatment started), or the date of death for any reason in the absence of PD. Diagnosis of PD was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions.|Up to 2 years|Safety Population included all registered participants who received at least one study treatment and had at least one safety follow-up. Patients without PD at the time of analysis were censored on the date of the last tumour assessment. Patients without PD who received a second anti-cancer therapy were censored prior to start of new therapy.|||months||95% Confidence Interval|Median
2614339|NCT02013206|Secondary|Time to Progression|Time to progression was defined as the time from start of treatment until the first date criteria for Progressive Disease (PD) was met (taking as reference the smallest measurements recorded since the treatment started). Diagnosis of PD was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 2 years|Safety Population included all registered patients who received at least 1 dose of study treatment and had at least 1 safety follow-up. Patients without PD at the time of analysis were censored on the date of the last tumour assessment. Patients without PD who received a second anti-cancer therapy were censored prior to start of new therapy.|||months||95% Confidence Interval|Median
2614340|NCT02013206|Secondary|Duration of Response|Duration of overall response was defined as the time in months from Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST) until the first date Progressive Disease (PD) was objectively documented (taking as reference for PD the smallest measurements recorded since the treatment started) or until the date of death. CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels.PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. PD was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 2 years|Participants from the Intent-to-Treat (ITT) Population, that included all participants, with CR or PR. Patients still responding to treatment at the time of analysis were treated as censored observations for duration of response on the date of the last tumour assessment.|||months||95% Confidence Interval|Median
2614357|NCT02013050|Secondary|"Percent of Patients With RECIST 1.1 Classification of Complete Response"|"The RECIST 1.1 scoring system evaluates both the defined (target) tumor, the non-target lesions, and the appearance of new lesions on radiologic scans as follows:~Target Lesion :~Complete Response (CR): All target lesions gone Partial Response (PR): >30% decrease from Baseline Progressive Disease (PD): >20% increase from smallest sum of longest diameter recorded since treatment started (best response) Stable Disease (SD): Neither PD nor PR~Non-Target Lesion:~Complete Response (CR): All non-target lesions gone,Tumor markers gone Stable Disease (SD): Persistence of ≥1 non-target lesion, Tumor marker level elevated Progressive Disease: Enlargement of non-target lesions"|12 months after end of therapy||||percentage of participants|||Number
2614341|NCT02013206|Secondary|Disease Control Rate|Disease Control Rate was defined as the percentage of participants with Complete Response (CR), Partial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumours (RECIST). CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started; for non-target lesions persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.|Up to 2 years|Intent-to-Treat Population included all registered participants.|||percentage of participants||95% Confidence Interval|Number
2614342|NCT02013206|Secondary|Objective Response Rate|"Objective response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) by Response Evaluation Criteria in Solid Tumours (RECIST). The best overall response was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). The patient's best response assignment depended on the achievement of both measurement and confirmation criteria. To be assigned the status of PR or CR, changes in tumour measurements were to be confirmed by repeated assessments no less than 4 weeks after the criteria for response were first met.~CR was defined as the disappearance of all target lesions; for non-target lesions disappearance of lesions and normal tumour marker levels. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, using as reference the Baseline sum LD."|Up to 2 years|Intent-to-Treat Population included all registered participants.|||percentage of participants||95% Confidence Interval|Number
2614343|NCT02013206|Primary|Non-Progression Rate (NPR) at 8 Weeks|Non-Progressive Rate (NPR) was defined as the percentage of participants without progression (had stable disease (SD) or better) based on (Response Evaluation Criteria in Solid Tumours (RECIST) criteria 8 weeks after start of treatment. Diagnosis of Progressive Disease (PD) was made by objective criteria (RECIST criteria) on the target lesion(s), or by documenting, with Computerised Tomography/Magnetic Resonance Imaging (CT/MRI) scans, the presence of newly occurring lesion(s) arising outside the scanned areas of the target lesions. PD required at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Week 8|Intent-to-Treat Population included all registered participants.|||percentage of participants||95% Confidence Interval|Number
2614344|NCT02013180|Primary|Assesment of Serum Zinc/PSA Ratio in Patients With Prostate Cancer and Benign Prostatic Diseases|Does the zinc/PSA ratio show statistically signifacant difference in patients with prostate cancer?|measurement of serum zinc and PSA levels are performed prior to transrectal prostat biopsy; pathologic evaluation of biopsy specimens are performed within 2-3 weeks||||ratio||Inter-Quartile Range|Median
2614345|NCT02013167|Secondary|Time to a 10-point Decrease From Baseline in Global Health Status and Quality of Life or Death|"The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) is a 30-item questionnaire that assesses the health related quality of life of cancer patients. The EORTC QLQ-C30 consists of a global health status/quality of life (QoL) scale, 5 functional scales, 3 symptom scales, and 6 single items.~The global health/QoL scale consists of 2 questions that ask participants to rate their overall health and overall quality of life durig the past week on a scale from 1 (very poor) to 7 (excellent). The scale score was derived as the sum of each score and transformed to a scale from 0 to 100 where higher scores represent a high QoL.~Time to a ≥10-point decrease from baseline GHS/QoL or death, whichever came first, was calculated from baseline. Participants still alive and without a 10-point decrease in GHS/QoL EORTC QLQ-C30 were censored on their last EORTC QLQ-C30 assessment date."|From randomization until the data cut-off date of 04 January 2016; EORTC QLQ-C30 was assessed on day 1, 8, 15, and 29 during cycle 1; days 1, 15, and 29 in cycle 2 and each consolidation cycle, and 30-days following the last dose of drug treatment.|EORTC QLQ-C30 analysis set included all randomized participants with a non-missing baseline and at least 1 non-missing postbaseline result of any EORTC QLQ-C30 scales/item.|||months||95% Confidence Interval|Median
2614346|NCT02013167|Secondary|Number of Participants With Anti-blinatumomab Antibodies|Anti-blinatumomab binding antibodies were evaluated using a validated electrochemiluminescence (ECL)-based assay (binding assay). Samples positive for binding were analyzed using a cell-based bioassay to determine if the detected antibodies had neutralizing properties (neutralizing assay).|Samples were collected on day 29 at the end of cycle 2 and 30 days after the last dose of blinatumomab (median duration of treatment was 70 days).|Participants who received blinatumomab with available post-baseline antibody data.|||participants|||Number
2614347|NCT02013167|Secondary|100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant|"The analysis of 100-day mortality after allogeneic HSCT was assessed for participants who achieved a best response of CR/CRh*CTi within 12 weeks of treatment initiation, who received an allogeneic HSCT and did not receive any additional anticancer treatment before the transplant. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT.~The 100-day mortality rate after allogeneic HSCT was defined as the percentage of participants having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods. Participants alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive."|100 days, from the date of allogeneic HSCT until the data cut-off date of 04 January 2016|Randomized participants with a best response of CR/CRh*/CRi within 12 weeks of treatment initiation and who received an allogeneic HSC without anti-cancer therapy prior to allogeneic HSCT.|||percentage of participants||95% Confidence Interval|Number
2614358|NCT02013050|Secondary|Survival||12 months after end of therapy|Safety Population: all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug that they actually received instead of the drug dose they were randomized. 2 patients were randomized but never received drug and are excluded. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942.|||percentage of participants|||Number
2614359|NCT02013050|Secondary|Incidence of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin||4 weeks after end of therapy||||percentage of participants|||Number
2614360|NCT02013050|Secondary|Duration of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin||4 weeks after end of therapy||||days||95% Confidence Interval|Median
2614348|NCT02013167|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded for severity according to the CTCAE version 4.0, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.~Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.~Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.~Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to blinatumomab based on response to the question: Is there a reasonable possibility that the event may have been caused by blinatumomab or other protocol-specified therapies/procedures?"|From first dose of protocol-specified therapy until 30 days after the last dose, up to the data cut-off date of 04 January 2016; median duration of treatment was 5 days in the SOC group and 70 days in the blinatumomab group.|All participants who received protocol-specified therapy analyzed according to the treatment they received.|||participants|||Number
2614349|NCT02013167|Secondary|Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT)||Up to the data cut-off date of 04 January 2016; maximum time on study was 23 months.|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2614350|NCT02013167|Secondary|Percentage of Participants With Minimal Residual Disease (MRD) Within 12 Weeks of Treatment Initiation|Bone marrow samples were evaluated for MRD remission by a central laboratory. MRD remission was defined as the occurrence of an MRD level below 10^-4 measured by quantitative reverse transcription polymerase chain reaction (PCR) or flow cytometry.|12 weeks|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2614351|NCT02013167|Secondary|Duration of Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi)|Duration of CR/CRh*/CRi, calculated only for participants who achieved a CR/CRh*/CRi, was calculated from the date a CR/CRh*/CRi was first achieved until the earliest date of a disease assessment indicating a relapse event or death, whichever occurred first. Participants who did not have a relapse event were censored on their last disease assessment date.|Up to the data cut-off date of 04 January 2016; median observation time was 10.8 months in the SOC group and 7.2 months in the blinatumomab group.|Randomized participants with a best response of CR/CRh*/CRi within 12 weeks of treatment initiation.|||months||95% Confidence Interval|Median
2614352|NCT02013167|Secondary|Duration of Complete Remission|Duration of complete remission, calculated only for participants who achieved a CR, was calculated from the date a CR was first achieved until the earliest date of a disease assessment indicating a relapse event or death, whichever occurred first. Participants who did not have a relapse event were censored on their last disease assessment date.|Up to the data cut-off date of 04 January 2016; median observation time was 10.8 months in the SOC group and 7.0 months in the blinatumomab group.|Randomized participants with a best response of complete remission within 12 weeks of treatment initiation.|||months||95% Confidence Interval|Median
2614353|NCT02013167|Secondary|Event Free Survival (EFS)|"Event free survival was defined as the time from randomization until a documented relapse after achieving CR/CRh*/CRi or death, whichever occurred first. Participants who failed to achieve a CR/CRh*/CRi within 12 weeks of treatment initiation were considered as non-responders and assigned an EFS duration of 1 day. Participants still alive and relapse-free were censored on their last disease assessment date.~A relapse event was any one of the following:~Hematological relapse: proportion of blasts in bone marrow >5% or blasts in peripheral blood after documented CR or CRh* or CRi~Progressive disease: An increase from baseline of at least 25% of bone marrow blasts or an absolute increase of at least 5,000 cells/μL in the number of circulating leukemia cells~Extramedullary relapse: extramedullary lesion that is new or increased by 50% from nadir as assessed by Cheson criteria.~The Kaplan-Meier estimate of EFS at 6 months is reported."|6 months|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2614354|NCT02013167|Secondary|Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) Within 12 Weeks of Treatment Initiation|"Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts.~Complete remission was defined as having ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts: platelets > 100,000/μl, and ANC > 1,000/μl.~Complete Remission with partial hematological recovery (CRh*) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease and partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl.~Complete remission with incomplete hematological recovery (CRi) was defined as ≤ 5% blasts in the bone marrow, no evidence of disease and incomplete recovery of peripheral blood counts: platelets > 100,000/μl or ANC > 1000 (but not both)."|12 weeks|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2614355|NCT02013167|Secondary|Percentage of Participants With Complete Remission Within 12 Weeks of Treatment Initiation|"Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts.~Complete Remission (CR) was defined as having ≤ 5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1,000/μl. CR must have occurred within 12 weeks of the first dose of therapy."|12 weeks|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2614356|NCT02013167|Primary|Overall Survival|Overall survival (OS) was calculated from time of randomization until death due to any cause. Participants still alive were censored at the date they were last known to be alive.|From randomization until the data cut-off date of 04 January 2016; median observation time was 11.8 months in the SOC group and 11.7 months in the blinatumomab group.|All randomized participants|||months||95% Confidence Interval|Median
2614376|NCT02012608|Primary|Excessive Radiation Toxicity as Defined by Radiation Therapy Oncology Group (RTOG) Acute Scale of Radiation-toxicity Criteria|"The primary efficacy outcome will be excessive toxicity, which will be defined as a score of 2 or higher using the Radiation Therapy Oncology Group (RTOG) Acute scale of radiation-toxicity criteria when scored on either the 12-day or 30-day assessment time.~The RTOG scale ranges from 0-4 with 0 being defined as no change."|12 days and 30 days|No data displayed because Outcome Measure has zero total participants analyzed and no data was collected.||||||
2614361|NCT02013050|Secondary|"Percent of Patients With RECIST 1.1 Classification of Complete Response"|"The RECIST 1.1 scoring system evaluates both the defined (target) tumor, the non-target lesions, and the appearance of new lesions on radiologic scans as follows:~Target Lesion :~Complete Response (CR): All target lesions gone Partial Response (PR): >30% decrease from Baseline Progressive Disease (PD): >20% increase from smallest sum of longest diameter recorded since treatment started (best response) Stable Disease (SD): Neither PD nor PR~Non-Target Lesion:~Complete Response (CR): All non-target lesions gone,Tumor markers gone Stable Disease (SD): Persistence of ≥1 non-target lesion, Tumor marker level elevated Progressive Disease: Enlargement of non-target lesions"|4 weeks after end of therapy||||percentage of participants|||Number
2614362|NCT02013050|Secondary|Incidence of Clinically Reported, Non-fungal Infections||4 weeks after end of therapy||||percentage of participants|||Number
2614363|NCT02013050|Secondary|Duration of Severe Oral Mucositis (SOM)|OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3.|4 weeks after end of therapy||||WHO score * days||95% Confidence Interval|Median
2614364|NCT02013050|Secondary|Residual Severe Oral Mucositis (SOM)|OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3.|4 weeks after end of therapy||||percentage of participants|||Number
2614365|NCT02013050|Primary|Duration of Severe Oral Mucositis (SOM)|Duration of SOM was defined as the number of days from the onset of SOM until resolution of SOM. If the patient did not meet the requirements for resolution of SOM by the 1-month follow up visit, he/she was considered censored at the 1-month follow-up visit (or point of discontinuation of the study, if the patient had discontinued prior to the end of planned treatment). Patients who did not experience SOM were assigned a duration of 0.01. OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4.|4 weeks after end of therapy||||days||95% Confidence Interval|Median
2614366|NCT02012959|Secondary|Fluid Balance (Intake Minus Output) During Treatment Phase A|Every 6 hours and for the 24-hour daily interval on Days 1 and 2 during Treatment Phase A, fluid balance (milliliters [mL]) was determined by fluid intake (oral and intravenous) minus urine output. Improved fluid balance would be indicated through the induction of increased urine volume. Fluid balance was monitored per institutional guidelines.|Every 6 hours on Days 1 and 2|Treatment Phase A: all participants in the Phase A Safety Sample and who had baseline and at least 1 postbaseline serum sodium evaluation in Phase A.|||mL||Standard Deviation|Mean
2614367|NCT02012959|Secondary|Change In Serum Sodium Concentration During Treatment Phase A|Change in serum sodium concentration (mEq/L) from baseline to the end of Day 2 (or 2a) during Treatment Phase A for all participants (responders and non-responders) is reported.|Baseline, Day 2/2a|Treatment Phase A: all participants in the Phase A Safety Sample and who had baseline and at least 1 postbaseline serum sodium evaluation in Phase A.|||mEq/L||Standard Deviation|Mean
2614368|NCT02012959|Primary|Change In Serum Sodium Concentration For Responders|Change in serum sodium concentration (mEq/L) for responders from Day 2 (or Day 2a) at the end of Treatment Phase A (where all participants received tolvaptan) to the end of Treatment Phase B for the Early compared to Late Withdrawal groups is reported. Once a participant was randomized to Treatment Phase B, any additional therapies for the purpose of raising serum sodium, including fluid restriction, were considered rescue therapy. Upon receipt of rescue therapy, a participant's endpoint data was collected and then censored from the efficacy analysis thereafter, unless specified.|Day 2/2a, Day 4|Treatment Phase B Responders: full analysis dataset comprised of all participants in the Phase B Safety Sample with both baseline and at least 1 postrandomization serum sodium evaluation in Phase B.|||mEq/L||Standard Deviation|Mean
2614369|NCT02012686|Primary|Numerical Rating Scale of Posterior Neck Pain 48 Hours After Thyroidectomy|numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable|48 hours after thyroidectomy||||scores on a scale||Full Range|Median
2614370|NCT02012686|Primary|Numerical Rating Scale of Posterior Neck Pain 24 Hours After Thyroidectomy|numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable|24 hours after thyroidectomy||||scores on a scale||Inter-Quartile Range|Median
2614371|NCT02012686|Primary|Numerical Rating Scale of Posterior Neck Pain 6 Hours After Thyroidectomy|numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable|6 hours after thyroidectomy||||scores on a scale||Inter-Quartile Range|Median
2614372|NCT02012686|Primary|Numerical Rating Scale of Posterior Neck Pain 0.5 Hours After Thyroidectomy|numerical rating scale from 0 - 10. where 0 indicates no pain and 10 indicates the worst pain imaginable|0.5 hours after thyroidectomy||||scores on a scale||Full Range|Median
2614373|NCT02012621|Primary|Adjusted Odds Ratio of Level of Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) Associated With Odds of HIV Viral Suppression at Next Study Visit|HIV viral load, binary cutoff at assay level of detection (<20 copies/mL vs. >= 20 copies/mL); drug concentration (TFV-DP) <800 femtomole (fmol)/punch) vs reference group of drug concentration (TFV-DP) >= 1650 fmol/punch; adjusted odds ratio calculated using generalized estimating equations|Up to 48 Weeks|Paired drug concentration (TFV-DP) and HIV VL assessments were available from 451 participants|||Adjusted odds ratio (aOR)||95% Confidence Interval|Number
2614374|NCT02012621|Primary|Adjusted Odds Ratio of Three-month Self-reported Adeherence Associated With Odds of HIV Viral Suppression at All Study Visits|HIV viral load, binary cutoff at assay level of detection (<20 copies/mL vs. >= 20 copies/mL); reference group: three-month self-reported adherence <28.5% vs. three-month self-reported adherence 100%; adherence cutoffs established in prior research|Up to 48 Weeks|Three-month self-reported adherence data were available from 482 participants|||Adjusted odds ratio (aOR)||95% Confidence Interval|Number
2614375|NCT02012621|Primary|Adjusted Odds Ratio of Level of Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) Associated With Odds of HIV Viral Suppression at All Study Visits|HIV viral load, binary cutoff at assay level of detection (<20 copies/mL vs. >= 20 copies/mL); reference group: drug concentration (TFV-DP) < 350 femtomole (fmol)/punch vs. drug concentration (TFV-DP) >= 1850 fmol/punch; adjusted odds ratio calculated using generalized estimating equations; concentration cutoffs established in prior research of healthy volunteers|Up to 48 Weeks|Drug concentrations were available from 532 participants|||Adjusted odds ratio (aOR)||95% Confidence Interval|Number
2614377|NCT02012582|Primary|Safety and Tolerability of VAS203 in Patients With Moderate and Severe TBI|"Tolerability (good, satisfactory, sufficient, poor) of VAS203 in patients with moderate and severe TBI, as judged by the investigators at day 14.~Safety outcome measure description see safety section"|14 days||||participants|||Number
2614378|NCT02012582|Post-Hoc|Extended Glasgow Outcome Score (eGOS)|"Scoring: Range from 1 (worst outcome) to 8 (good outcome). The patient´s overall rating is based on the lowest outcome category indicated on the scale.~Score Description~Dead~Vegetative State~Lower Severe Disability~Upper Severe Disability~Lower Moderate Disability~Upper Moderate Disability~Lower Good Recovery~Upper Good Recovery"|6 months after start of treatment||||units on a scale||Full Range|Median
2614379|NCT02012582|Secondary|Therapy Intensity Level Score|"Therapy Intensity Level Score: Total Score calculated daily as the sum of all individual measures, range from 3 (good outcome) to 50 (worst outcome):~Scores:~0-2 Head elevation 0-8 Sedation 0-1 Paralysis 1-3 Hyperventilation 0-2 Increased Oxygenation 1-3 Cooling 0-2 Osmotherapy 0-3 CSF Drainage 0-1 Red Blood Cell Transfusion 1-3 Cerebral perfusion pressure 0-1 Surgery for mass lesion 0/5/10 none/unilateral/bilateral Decompressive Craniectomy 0/10 Laparatomy to treat intracranial hypertension due to abdominal hypertension"|Daily from day 1 to day 6||||units on a scale||Standard Deviation|Mean
2614380|NCT02012582|Secondary|Duration (Number of Hours) of Cerebral Perfusion Pressure (CPP) < 60 mmHg|Duration (number of hours) of cerebral perfusion pressure (CPP) < 60 mmHg calculated from ICP and mean arterial blood pressure (MAP): CPP = MAP - ICP)|Hourly from start of infusion to 144 hours||||hours||Standard Deviation|Mean
2614381|NCT02012582|Secondary|Duration (Number of Time-points) of Intracranial Pressure (ICP) > 20 mmHg||Hourly from start of infusion to 144 hours||||hours||Standard Deviation|Mean
2614382|NCT02012491|Secondary|Adverse Event Reported by Participants||30 Days||||adverse events||Full Range|Mean
2614383|NCT02012491|Secondary|Frequency of Serious Adverse Events Between Study Arms.||30 days||||Participants|||Count of Participants
2614384|NCT02012491|Primary|Uterine Asperation|Surgical removal of the miscarriage.|30 Days||||Participants|||Count of Participants
2614385|NCT02012491|Primary|Gestational Sac Expulsion by the 30-day Telephone Call||30 Days||||Participants|||Count of Participants
2614386|NCT02012491|Primary|Gestational Sac Expulsion by the Second Follow-up Visit at Day 8||Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical)||||Participants|||Count of Participants
2614387|NCT02012491|Primary|Gestational Sac Expulsion With One Treatment Dose on Day 3 (Visit 2) and no Need for Additional Medical or Surgical Intervention Within 30 Days of Treatment.||Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done||||Participants|||Count of Participants
2614388|NCT02012452|Secondary|Percent Abstinent From Tobacco Use|biochemically confirmed abstinence from tobacco using self-report, cotinine, and CO breath samples|end of treatment|If participants did not come the follow-up visit they were assumed to be smokers. If they attended a later follow-up visit, tobacco use was retroactively assessed.|||percent abstinent|||Number
2614389|NCT02012452|Primary|Clinician Administered PTSD Scale|posttraumatic stress disorder clinician rated symptom ratings; scores range from 0-80 (with higher scores indicating greater PTSD severity)|end of 6 week PTSD treatment||||units on a scale||Standard Deviation|Mean
2614390|NCT02012348|Secondary|Relative GAS Survival|A skin swab will be used to measure the bacterial survival 1 hour after bacteria application (2 hours post washing with soap). The bacteria being applied and subsequently measured is Group A Streptococcus (GAS). The bacterial survival is expressed as abundance of GAS relative to abundance of other bacterial species isolated from the swab.|1 hour after bacteria application / 2 hours post washing||||percentage overall bacterial abundance||Standard Error|Mean
2614391|NCT02012348|Primary|Relative GAS Survival|A skin swab will be used to measure the bacterial survival 30 minutes after bacteria application and soap treatment. The bacteria being applied and subsequently measured is Group A Streptococcus (GAS). The bacterial survival is expressed as abundance of GAS relative to abundance of other bacterial species isolated from the swab.|30 minutes post-bacteria application||||percentage overall bacterial abundance||Standard Error|Mean
2614392|NCT02012283|Secondary|Difference in Broccoli Intake With or Without Spice Among Higher Restraint Eaters and Low Restraint Eaters|Twenty subjects were categorized based on their score on the Three-Factor Eating Questionnaire with score greater than 2 defined as high restraint (HR), and 2 or less defined as low restraint (LR) eaters.|1 day||||grams||Standard Deviation|Mean
2614393|NCT02012283|Primary|Differences Between Plain and Spiced Vegetables Intake|Vegetable intake (grams) was measured while ingesting using an Universal Eating Monitor integrating a hidden weighing apparatus with specialized data collection software to analyze human eating.|1 day|One female low restraint eater produced irregular data that was removed from analysis population. One male high restraint eater data was removed too to obtain equal number.|||gram||Standard Deviation|Mean
2614394|NCT02012218|Primary|Mean Change From Baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|"The MADRS was used as the primary efficacy assessment of level of depression. The MADRS was administered using the Structured Interview Guide for the MADRS. Detailed instructions were provided.The MADRS consists of 10 items each, with 7 defined grades of severity (ie, 0 to 6, with 0 being the best rating and 6 being the worst rating). The MADRS total score is the sum of ratings for all 10 items; therefore, possible total scores range from 0 to 60. The MADRS total score least squares (LS) mean changes from baseline to Week 6 is mentioned below."|Baseline and Week 6|All participants who took at least one dose of brexpiprazole and who had a valid baseline assessment and at least one valid post-baseline efficacy assessment.|||Units on a scale||Standard Error|Least Squares Mean
2614395|NCT02012192|Primary|Progression Free Survival (PFS)|evaluate the efficacy of ganetespib in combination with weekly paclitaxel compared to weekly paclitaxel alone as measured by Progression-free survival (PFS). Response or progression will be evaluated in this study according to Response Evaluation Criteria In Solid Tumors Criteria version 1.1., CA-125 according to published GCIG criteria, and by the investigator on the basis of physical and/or gynaecological examinations.|Time until progression (median w/o new drug 4 months)|ITT population|||months||95% Confidence Interval|Median
2614837|NCT02006758|Secondary|Percentage of Subjects Achieving Office Systolic Blood Pressure < 140 mmHg at 1 Month||1 month|62 out of 67 participants analyzed for percentage of subjects achieving office Systolic Blood Pressure < 140 mmHg at 1 month.|||Participants|||Count of Participants
2614396|NCT02011945|Secondary|Duration of Molecular Response 4.5 (MR4.5) - CML-AP Participants|will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment|Up to 36 Months|CML-AP Participants||||||
2614397|NCT02011945|Secondary|Duration of Molecular Response 4.5 (MR4.5) - CML-CP Prior Dasatinib Participants|will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment|Up to 36 Months|CML-CP Prior Dasatinib Participants||||||
2614398|NCT02011945|Secondary|Duration of Molecular Response 4.5 (MR4.5) - CML-CP No Prior Dasatinib Participants|will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment|Up to 36 Months|CML-CP No Prior Dasatinib Participants|||Months||95% Confidence Interval|Median
2614399|NCT02011945|Secondary|Time to Molecular Response 4.5(MR4.5) - CML-AP Participants|measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.|Up to 36 Months|CML-AP Participants|||Months||95% Confidence Interval|Median
2614400|NCT02011945|Secondary|Time to Molecular Response 4.5(MR4.5) - CML-CP Prior Dasatinib Participants|measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.|Up to 36 Months|CML-CP Prior Dasatinib Participants|||Months||95% Confidence Interval|Median
2614401|NCT02011945|Secondary|Time to Molecular Response 4.5(MR4.5) - CML-CP No Prior Dasatinib Participants|measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.|Up to 36 Months|CML-CP No Prior Dasatinib Participants|||Months||95% Confidence Interval|Median
2614402|NCT02011945|Secondary|Duration of Major Molecular Response (MMR) - CML-AP Participants|will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment|Up to 36 Months|CML-AP Participants|||Months||95% Confidence Interval|Median
2614403|NCT02011945|Secondary|Duration of Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants|will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment|Up to 36 Months|CML-CP Prior Dasatinib Participants|||Months||95% Confidence Interval|Median
2614404|NCT02011945|Secondary|Duration of Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants|will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment|Up to 36 Months|CML-CP No Prior Dasatinib participants|||Months||95% Confidence Interval|Median
2614405|NCT02011945|Secondary|Time to Major Molecular Response (MMR) - CML-AP Participants|measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.|Up to 36 Months|CML-AP Participants|||Months||95% Confidence Interval|Median
2614406|NCT02011945|Secondary|Time to Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants|measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.|Up to 36 Months|CML-CP Prior Dasatinib participants|||Months||95% Confidence Interval|Median
2614407|NCT02011945|Secondary|Time to Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants|measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.|Up to 36 Months|CML-CP No Prior Dasatinib Subjects|||Months||95% Confidence Interval|Median
2614408|NCT02011945|Secondary|Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants|"Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).~A molecular response 4.5 (MR4.5) was defined as ≥ 4.5-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.00316% on the International Scale (IS)."|upto 36 Months|All treated Participants, CML-AP Participants|||Percentage||95% Confidence Interval|Number
2614409|NCT02011945|Secondary|Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants|"Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).~A molecular response 4.5 (MR4.5) was defined as ≥ 4.5-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.00316% on the International Scale (IS)."|upto 36 Months|All treated Participants, CML-CP prior Dasatinib participants|||Percentage||95% Confidence Interval|Number
2614410|NCT02011945|Secondary|Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants|"Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).~A molecular response 4.5 (MR4.5) was defined as ≥ 4.5-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.00316% on the International Scale (IS)."|upto 36 Months|All treated Participants, CML-CP no prior Dasatinib participants|||Percentage||95% Confidence Interval|Number
2614411|NCT02011945|Secondary|Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants|"Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).~MMR is defined as ≥ 3-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.1% on the International Scale (IS)."|upto 36 Months|All treated Participants, CML-AP Participants|||Percentage||95% Confidence Interval|Number
2614412|NCT02011945|Secondary|Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants|"Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).~MMR is defined as ≥ 3-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.1% on the International Scale (IS)."|upto 36 Months|All treated Participants, CML-CP prior Dasatinib participants|||Percentage||95% Confidence Interval|Number
2614413|NCT02011945|Secondary|Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants|"Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).~MMR is defined as ≥ 3-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.1% on the International Scale (IS)."|upto 36 Months|All treated Participants, CML-CP no prior Dasatinib participants|||Percentage of Participants||95% Confidence Interval|Number
2614414|NCT02011945|Primary|Incidence of Laboratory Abnormalities in Specific Thyroid Tests|Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN)|Up to 40 Months|All Treated Participants|||Number of Incidences|||Number
2614415|NCT02011945|Primary|Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests|"The number of participants with an abnormal Liver function test.~Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN)"|Up to 40 Months|All Treated Participants with at least one treatment measure|||Participants|||Number
2614416|NCT02011945|Primary|Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology|The number of participants with a shift in laboratory test results from baseline to Grade 3-4 in hematology|Up to 40 Months|All Treated Participants|||Participants|||Number
2614417|NCT02011945|Primary|Incidence of Serious Adverse Events (SAEs)|Any untoward medical occurrence that at any dose: results in death, is life threatening, requires in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a important medical event.Requires inpatient hospitalization or causes prolongation of existing hospitalization, results.|Initiation of study drug to within 100 days of discontinuation of nivolumab dosing and 30 days of dasatinib dosing|All Treated Participants|||Number of Adverse Events|||Number
2614418|NCT02011945|Primary|Incidence of Adverse Events (AEs)|Any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.|Initiation of study drug to discontinuation of nivolumab stop date + 100 days or discontinuation of dasatinib + 30 days|All Treated Participants|||Number of Adverse Events|||Number
2614419|NCT02011945|Primary|Incidence of Dose Limiting Toxicities (DLT)|"DLT will be determined based on the incidence and intensity of drug related adverse events (AEs). The following drug-related AEs (whether related to one or both agents) occurring during the first 6 weeks of combined treatment with both dasatinib plus nivolumab (ie, Weeks 3 to 8, inclusive) would be considered DLTs:~Grade 4 hematologic AE lasting > 7 days despite appropriate medical intervention, except as noted below;~Grade 3 or Grade 4 nonhematologic AE irrespective of duration;~Grade 2 nonhematologic AE lasting > 7 days despite appropriate medical intervention (exception: asymptomatic laboratory values of Grade 2 which do not require medical intervention);~Any toxicity managed by discontinuation of nivolumab;~Grade ≥ 2 AE not controlled by medical intervention and requiring dasatinib treatment interruption for > 28 consecutive days;~Grade ≥ 2 AE not controlled by medical intervention and requiring missing 2 consecutive doses of nivolumab."|Week 3 to week 6|All Treated Participants|||Number of Incidence|||Number
2614420|NCT02011893|Secondary|Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation|Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation to evaluate for superiority of Burst Stimulation. Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.|Over 7 days after 3 months of treatment of burst or tonic stimulation|All subjects randomized were analyzed for this outcome measure. Statistical measures were used to impute Visual Analog Scale (VAS) scores according the study Statistical Analysis Plan (SAP) if data was not available.|||mm||Standard Deviation|Mean
2614421|NCT02011893|Secondary|Percentage of Paresthesia Coverage|Paresthesia mapping (percentage of paresthesia coverage) analyzed to demonstrate the differences between Burst and Tonic Stimulation. Data is presented as areas of paresthesia reported while utilizing either Burst or Tonic Stimulation as a percentage of the total number of areas possible.|During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation|There were 73 subjects in whom paresthesia coverage data at both the 12 and 24 week visits were available and included in the analysis. The remaining 23 subjects were excluded due to questionnaire completion errors at the time of data collection.|||Percentage of paresthesia areas||Standard Deviation|Mean
2614422|NCT02011893|Secondary|Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS)|Number of subjects responding to Burst and Tonic Stimulation defined as 30% or greater decrease in overall Visual Analog Scale (VAS) score from baseline. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.|Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation|All subjects randomized were analyzed for this outcome measure. Statistical measures were used to impute Visual Analog Scale (VAS) scores according the study Statistical Analysis Plan (SAP) if data was not available.|||participants|||Number
2614423|NCT02011893|Primary|Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain|Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, from 0 mm to 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.|Over 7 days after 3 months of treatment of burst or tonic stimulation|All subjects randomized were analyzed for this outcome measure. Statistical measures were used to impute Visual Analog Scale (VAS) scores according the study Statistical Analysis Plan (SAP) if data was not available.|||mm||Standard Deviation|Mean
2614424|NCT02011542|Secondary|Change in Chronic Fatigue (1-5 Scale) From Baseline|Efficacy of VSL #3 in reducing non-intestinal symptoms of IBS is measured using chronic fatigue scale at 2,4,6,8, weeks|8 weeks|Clinical trial is ongoing; change in collaborator and investigational product required new study registration. Clinical trial results for all participants will be reported upon study completion in record NCT03078530.||||||
2614425|NCT02011542|Primary|Improvement in the Bowel Symptom Scale (BSS) From Baseline|Efficacy of VSL #3 in Irritable Bowel Syndrome (IBS) related symptoms in Gulf War illness is measured using BSS at 2, 4, 6, 8 wks|8 weeks|Clinical trial is ongoing; change in collaborator and investigational product required new study registration. Clinical trial results for all participants will be reported upon study completion in record NCT03078530.||||||
2614426|NCT02011516|Primary|Urine Drug Screen|Change from positive to negative over the 12 weeks of a medication regimen|study weeks 1-12||||Participants|||Count of Participants
2614427|NCT02011490|Primary|Geometric Mean Apparent First-order Terminal Elimination Rate Constant (λz) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. λz was calculated by regression of the terminal log-linear portion of the plasma concentration-time profile.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||1/hr||Geometric Coefficient of Variation|Geometric Mean
2614428|NCT02011490|Primary|Geometric Mean Effective Half-life (t1/2eff) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. t½eff was calculated as ln(2)*MRT.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||hr||Geometric Coefficient of Variation|Geometric Mean
2614429|NCT02011490|Primary|Geometric Mean Apparent First-order Terminal Elimination Half-life (t1/2) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Elimination t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase, calculated as the natural log of 2 (ln[2])/λz.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||hr||Geometric Coefficient of Variation|Geometric Mean
2614430|NCT02011490|Primary|Median Time of the Last Measurable Plasma Concentration (Tlast) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Tlast was determined from the observed plasma concentration-time data.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||hr||Full Range|Median
2614431|NCT02011490|Primary|Median Time to Maximum Observed Plasma Concentration (Tmax) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Tmax was determined from the observed plasma concentration-time data.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||hr||Full Range|Median
2614447|NCT02011113|Secondary|Kaplan-Meier Estimates of Duration of Response|Duration of response (calculated for responders only) was defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria.|From first dose until the data cut-off date of 03 September 2014; maximum time for follow-up was 36 weeks|Duration of Response was not analyzed as there was insufficient data available at Cycle 2, Day 1 of study treatment. There was limited data evaluated and data were not analyzed.||||||
2614838|NCT02006758|Secondary|Mean Change in Ambulatory Diastolic Blood Pressure at 1 Month||Baseline and 1 month|23 out of 67 participants analyzed for mean change in ambulatory Diastolic Blood Pressure at 1 month.|||mmHg||Standard Deviation|Mean
2614432|NCT02011490|Primary|Geometric Mean Apparent Volume of Distribution Estimated at Steady-state (Vss) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Vss is the theoretical volume that the total amount of administered drug would have to occupy (if it were uniformly distributed), to provide the same concentration as it is in blood plasma at steady state, calculated as CL*MRT.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||L||Geometric Coefficient of Variation|Geometric Mean
2614433|NCT02011490|Primary|Geometric Mean of Mean Residence Time (MRT) of Unchanged Drug in the Systemic Circulation Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. MRT is defined as the mean duration of time a drug molecule is present in the systemic circulation.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||hr||Geometric Coefficient of Variation|Geometric Mean
2614434|NCT02011490|Primary|Geometric Mean Volume of Distribution During the Terminal Elimination Phase (Vz) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Vz was calculated as Dose/(AUC0-∞*λz).|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||L||Geometric Coefficient of Variation|Geometric Mean
2614435|NCT02011490|Primary|Geometric Mean Total Clearance (CL) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. CL is a quantitative measure of the rate at which a drug substance is removed from the body, calculated as Dose/AUC0-∞.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2614436|NCT02011490|Primary|Geometric Mean Percent of AUC0-∞ That Was Extrapolated (AUC%Extrap) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. AUC%extrap represents the percentage of the AUC0-∞ obtained by extrapolation, calculated as (1 - [AUC0-last/AUC0-∞]) multiplied by 100.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||Percent extrapolated||Geometric Coefficient of Variation|Geometric Mean
2614437|NCT02011490|Primary|Geometric Least Squares Mean Maximum Observed Plasma Concentration (Cmax) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. Cmax was determined from the observed plasma concentration-time data. The reported least squares mean is the geometric least squares mean, which is the back-transformed least squares mean from the ANOVA linear fixed-effect model performed on natural log-transformed values of Cmax. This calculation also provides the associated 95% confidence interval.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||ug/mL||95% Confidence Interval|Least Squares Mean
2614448|NCT02011113|Secondary|Time to Response (Later Cut-off Date)|Time to response was calculated as the time from the first dose to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|Included participants with at least a PR or better based on Assessment using IMWG criteria; EPP includes all participants who meet eligibility criteria, take at least one dose of study medication, and have a baseline and a post-baseline efficacy assessment.|||weeks||Full Range|Median
2614438|NCT02011490|Primary|Geometric Least Squares Mean Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. AUC0-last was determined by trapezoidal method. The reported least squares mean is the geometric least squares mean, which is the back-transformed least squares mean from the ANOVA linear fixed-effect model performed on natural log-transformed values of AUC0-last. This calculation also provides the associated 95% confidence interval.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||ug*hr/mL||95% Confidence Interval|Least Squares Mean
2614439|NCT02011490|Primary|Geometric Least Squares Mean Area Under the Plasma Drug Concentration-time Curve From Time Zero to Infinity (AUC0-∞) Following a Single IV Dose of Sugammadex|Plasma samples for determination of sugammadex pharmacokinetic parameters were obtained pre-dose and at specified post-dose time points. AUC0-∞ was calculated as the sum of the AUC to the last time point with a detectable plasma concentration (AUC0-last, determined by trapezoidal method) and the extrapolated area given by Cest,last/λz, where Cest,last is the estimated concentration corresponding to the time of the last measurable concentration and λz is the apparent first-order terminal elimination rate constant. For each subject, λz was calculated by regression of the terminal log-linear portion of the plasma concentration-time profile. The reported least squares mean is the geometric least squares mean, which is the back-transformed least squares mean from the analysis of variance (ANOVA) linear fixed-effect model performed on natural log-transformed values of AUC0-∞. This calculation also provides the associated 95% confidence interval.|For participants with: normal renal function - up to 48 hours post-dose (Part 1 + Part 2); moderate renal insufficiency - up to Day 28 (Part 1) or Day 10 (Part 2); severe renal insufficiency - up to Day 35 (Part 1) or Day 14 (Part 2)|Pharmacokinetic analysis was performed only for Part 2 data for participants in Part 2. Analysis was not conducted for Part 1, as review of drug concentration data, and dosing issues noted at investigative sites, indicated that in some participants, doses may not have been administered directly into vein, and likely infiltrated surrounding tissue.|||ug*hr/mL||95% Confidence Interval|Least Squares Mean
2614440|NCT02011464|Other Pre-specified|Side Effects of Analgesia|Secondary end points will include the incidence of opioid related side effects (nausea, vomiting, pruritis, constipation, respiratory depression, and hypoxia) and hemodynamic perturbations related to pain|72 hours post-operative|Number of patients with opioid related side effects (nausea, vomiting, pruritis, constipation, respiratory depression, and hypoxia) and hemodynamic perturbations related to pain|||participants|||Number
2614441|NCT02011464|Secondary|Post-operative Narcotic Use|Average postoperative narcotics administered in total milligrams of morphine equivalents|72 hours post-operative||||mgs||Standard Deviation|Mean
2614442|NCT02011464|Primary|Subjective Pain|Subject reported post-surgical pain using the visual analog scale (VAS) during the hospital stay and after discharge. This is a 0-10 point numeric rating scale where 0 is no pain and 10 is the highest level of pain.|72 hours post-operative||||units on a scale||Standard Deviation|Mean
2614443|NCT02011113|Secondary|Number of Participants With Adverse Events|Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above. Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the first treatment of the study medication and within 28 days after the last dose.|From first dose of study drug to final data cut-off date of 25 Sept 2015, maximum duration on treatment was 80.9 weeks|Safety population includes all participants who took at least one dose of study medication.|||participants|||Number
2614444|NCT02011113|Secondary|Kaplan-Meier Estimates of PFS (Later Cut-off Date)|PFS was calculated as the time from the first dosing to the first documented progressive disease, as determined by the investigators based on the IMWG Uniform Response criteria, or death, whichever occurred earlier|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.|||weeks||95% Confidence Interval|Median
2614445|NCT02011113|Secondary|Kaplan-Meier Estimates of Progression-free Survival (PFS)|PFS was calculated as the time from the first dosing to the first documented progressive disease, as determined by the investigators based on the IMWG Uniform Response criteria, or death, whichever occurred earlier|From the first dose until the data cut-off date of 03 September 2014; maximum time on treatment was 36.0 weeks|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.|||weeks||95% Confidence Interval|Median
2614446|NCT02011113|Secondary|Kaplan-Meier Estimates of Duration of Response (Later Cut-off Date)|Duration of response (calculated for responders only) was defined as time from the initial documented response (partial response or better) to confirmed disease progression, based on IMWG criteria.|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.|||weeks||95% Confidence Interval|Median
2614513|NCT02010255|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least one dose of study drug|||percentage of participants|||Number
2614449|NCT02011113|Secondary|Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria (Later Cut-off Date)|Myeloma response was defined as a best overall response of complete response (CR) or partial response (PR) CR is defined as: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions.|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|EEP includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.|||percentage of participants responding||95% Confidence Interval|Number
2614450|NCT02011113|Primary|Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria (Later Cut-off Date)|Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.|From the first dose until the final data cut-off date of 25 September 2015; maximum duration on treatment was 80.9 weeks|Efficacy Evaluable Population (EEP) includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.|||percentage of participants responding||95% Confidence Interval|Number
2614451|NCT02011113|Secondary|Time to Response|Time to response was calculated as the time from the first dose to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.|From the first dose until the data cut-off date of 03 September 2014. Maximum time on follow-up was 36.0 weeks.|Included participants with at least a PR or better based on Assessment using IMWG criteria.|||weeks||Full Range|Median
2614452|NCT02011113|Secondary|Myeloma Response Rate Based on European Group for Blood and Marrow Transplantation (EBMT) Criteria|Myeloma response was defined as a best overall response of complete response (CR) or partial response (PR) CR is defined as: - Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days. - <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed. - No increase in size or number of lytic bone lesions. - Disappearance of soft tissue plasmacytomas. PR requires all of the following: - ≥ 50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days. - Reduction in 24-hour urinary light chain extraction by ≥ 90% or to < 200 mg, maintained at least 42 days. - For patients with non-secretory myeloma, ≥ 50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days. - ≥ 50% reduction in the size of soft tissue plasmacytomas. - No increase in size or number of lytic bone lesions.|From first dose until the data cut-off date of 03 September 2014; maximum time in follow-up was 36.0 weeks|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.|||percentage of participants responding||95% Confidence Interval|Number
2614453|NCT02011113|Primary|Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria|Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.|From the first dose until the data cut-off date of 03 Sept 2014; Maximum time in follow-up was 36.0 weeks.|Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.|||percentage of participants responding||95% Confidence Interval|Number
2614454|NCT02010996|Primary|Early Complications of Vascular Zone||2 weeks||||participants|||Number
2614455|NCT02010775|Secondary|Percentage of Participants Who Achieved a Masseter Muscle Prominence Scale (MMPS) Grade ≤ 3 as Assessed by the Investigator|The investigator used visual inspection and palpation to grade the prominence of the participant's masseter muscle on the left and right sides of the face using the MMPS where: 1=minimal prominence (best), 2=mild prominence, 3=moderate prominence, 4=marked prominence, 5=very marked prominence (worst). The percentage of participants with grade 3 or less is reported.|Day 90 of Treatment Cycle 1|Participants from the mITT population, all randomized participants who received at least 1 injection of study treatment and had at least 1 follow-up visit, with data available for analysis at Day 90. Missing data was imputed using last observation carried forward.|||Percentage of participants||95% Confidence Interval|Number
2614529|NCT02010203|Secondary|Overall Disease-free Survival|Evaluate overall Disease Free Survival|Up to 3 years|Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.|||participants|||Number
2614456|NCT02010775|Primary|Change From Baseline in Lower Facial Volume Using VECTRA 3D Images|Lower facial volume was calculated from 3-dimensional (3D) images captured with the VECTRA M3 3D Stereophotogrammetry imaging system and was analyzed using computer assisted systems and predetermined facial landmarks. The difference in volume was measured between the select region of the baseline surface 3D model and the select region of the posttreatment surface 3D model. A negative change from Baseline (decrease in volume) indicates improvement.|Baseline (Day 1) to Day 90 of Treatment Cycle 1|Participants from the mITT population, all randomized participants who received at least 1 injection of study treatment and had at least 1 follow-up visit, with data available for analysis at Day 90. Change in lower facial volume was quantified in cm^3 using image subtraction techniques; as the Baseline is an image, no Baseline data are reported.|||cubic centimeter (cm^3)||Full Range|Least Squares Mean
2614457|NCT02010697|Other Pre-specified|Counseling|Did participants receive counseling|7-months post enrollment||||Participants|||Count of Participants
2614458|NCT02010697|Secondary|Number of Participants Reporting 30-day Abstinence|Assessment interview is conducted over the phone at 3-months post enrollment to determine 30-day abstinence. The interview will cover, as appropriate, tobacco use, use of quitting aids, and pattern of quitting (including slips and relapse situations).|3-months post enrollment||||Participants|||Count of Participants
2614459|NCT02010697|Secondary|Support for Quitting|"The number of participants who felt they had a lot of support for quitting or staying quit."|At intake||||Participants|||Count of Participants
2614460|NCT02010697|Primary|Number of Participants Reporting 30-day Abstinence|Assessment interview is conducted over the phone at 7-months post enrollment to determine 30-day abstinence. The interview will cover, as appropriate, tobacco use, use of quitting aids, and pattern of quitting (including slips and relapse situations).|7-months post enrollment||||Participants|||Count of Participants
2614461|NCT02010684|Secondary|Change From Baseline in Self-Efficacy (Diabetes Empowerment Scale) at 6 Months|The Diabetes Empowerment Scale Short Form (DES-SF) measures diabetes-related psychosocial self-efficacy. The questionnaire presents 8 statements on self-efficacy where participants rate how strongly they agree. The answers are summed to create a score where higher scores indicate more empowerment. The score range is 0 to 8.|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
2614462|NCT02010684|Secondary|Change From Baseline in Yale Physical Activity Scale - Index Summary Score at 6 Months|The Yale Physical Activity Scale measures physical function and activities of daily living. Five activity indices (vigorous activity, leisurely walking, moving, standing and sitting) are calculated by multiplying the frequency of activity with the duration and a weighted factor. The 5 indices are then summed to create an index summary. Higher scores indicate more activity. The minimum and maximum scores are 0 and 142.|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
2614463|NCT02010684|Secondary|Change From Baseline in EQ-5D at 6 Months|"The EQ-5D measures general quality of life. The index score is based on 5 questions about mobility, self-care, pain, usual activities, and psychological status. The EuroQol Group provides a U.S. preference-weighted algorithm to calculate the index scores. A score of 1 indicates no problems while a score of -0.11 indicates severe problems.~The scale score is based on a visual analog of a thermostat, where 0 represents worst imaginable health and 100 represents best imaginable health. Patients mark a tick for where they feel their health is on that scale."|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
2614464|NCT02010684|Secondary|Change From Baseline in Low Density Lipoprotein-C at 6 Months||Baseline and 6 months||||mg/dL||Standard Deviation|Mean
2614465|NCT02010684|Secondary|Change From Baseline in Blood Pressure at 6 Months||Baseline and 6 months||||mm Hg||Standard Deviation|Mean
2614466|NCT02010684|Primary|Change From Baseline in Depression Measures at 6 Months|"The Geriatric Depression Scale (GDS) measures depression in older adults. The short form we used consists of 15 yes or no questions. The scale range is 0 to 15, where higher scores indicate greater severity of depression.~The Patient Health Questionnaire-9 (PHQ-9) measures depression in patients. The questionnaire consists of 9 questions where patients self report how frequently they have depression symptoms over the past two weeks. The scale ranges is 0 to 27 where higher scores indicate greater severity of depression."|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
2614467|NCT02010684|Primary|Change From Baseline in Hemoglobin A1c at 6 Months|Hemoglobin A1c (HbA1c) measures glycemic control over the past three months. HbA1c was measured by a blood draw and laboratory test.|Baseline and 6 months||||percentage of glycated hemoglobin||Standard Deviation|Mean
2614468|NCT02010645|Primary|Overall Response Rate (ORR)|The primary endpoint is the overall response rate (ORR) based on the IWG-2006 criteria, which includes complete remission (CR), partial remission (PR), and hematologic improvement (HI).|28 days|One participant was not evaluable for response.|||Participants|||Count of Participants
2614469|NCT02010632|Secondary|Pharmacokinetic Profiles: Time to Maximum Plasma Concentration (Tmax)||Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7|||||||
2614470|NCT02010632|Secondary|Pharmacokinetic Profiles: The Maximum Plasma Concentration (Cmax)||Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7|||||||
2614471|NCT02010632|Secondary|Pharmacokinetic Profiles: Area Under the Concentration-Time Curve (AUC 0-24)||Blood collection at 0 (before dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7|||||||
2614472|NCT02010632|Primary|Pharmacodynamic Effect: The Platelet Inhibition Effect of Clopidogrel at the Various Times on Day 7 (0-24 Hours) (at Steady State)||Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7||||percent inhibition*hour||Standard Deviation|Mean
2614473|NCT02010567|Secondary|Disease-free Survival (DFS) and Overall Survival (OS) Based on Pathological Complete Response (pCR).|Phase II only - a comparison of DFS and OS for patients who achieve pCR and those who do not. DFS will be defined as the time from surgical resection until disease recurrence or death as a result of any cause.OS is defined as the time from surgical resection until death|6 years|||||||
2614474|NCT02010567|Secondary|Overall Survival (OS)|Phase II only - OS is defined as the time from surgical resection until death|6 years|||||||
2614475|NCT02010567|Secondary|Disease-free Survival (DFS)|Phase II only - DFS will be defined as the time from surgical resection until disease recurrence or death as a result of any cause.|6 years|||||||
2614476|NCT02010567|Secondary|Number of Participants With Grade 3 or Higher, Treatment-related Toxicities|Toxicity profile of CRLX101 when combined with capecitabine + radiotherapy to treat patients with locally advanced rectal cancer. Phase Ib and Phase II - Safety is the reported adverse event (AE) profile characterized by NCI CTCAE v4.0. The profile was limited to grade 3 or higher, treatment related AEs.|12 weeks||||participants with AE|||Number
2614477|NCT02010567|Secondary|Pathological Response Rate|"Pathologic response will be made based on microscopic assessment of the surgical specimen at the primary treatment site, including regional nodes and any peritumoral satellite nodules in the specimen, and categorized as outlined below as per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 7th edition.Determination of pathological response will be reported by the local pathologist.~Pathologic Complete Response (pCR): No gross or microscopic tumor identified anywhere within the surgical specimen. This must include: No evidence of malignant cells in the primary tumor specimen and No lymph nodes that contain tumor.~Moderate response: Single cells or small groups of cancer cells~Minimal response: Residual cancer outgrown by fibrosis~Poor response:Minimal or no tumor kill; extensive residual cancer"|12 weeks||||Participants|||Count of Participants
2614478|NCT02010567|Primary|Pathological Complete Response (pCR) Rate|Primary Objective Phase II: Pathological response will be made based on microscopic assessment of the surgical specimen at the primary treatment site. A pCR must include no gross or microscopic tumor identified anywhere within the surgical specimen. This must include:No evidence of malignant cells in the primary tumor specimen and No lymph nodes that contain tumor.|12 weeks||||percentage of participants with pCR||95% Confidence Interval|Number
2614479|NCT02010567|Primary|Maximum Tolerated Dose (MTD) of CRLX101 When Added to Standard Neoadjuvant Chemoradiotherapy Consisting of Capecitabine + Radiotherapy in Locally Advanced Rectal Cancer|The MTD is the highest dose of CRLX101 at which ≤1 out of 6 patients had a dose limiting toxicity (DLT) using CTCAE v4.0 toxicity criteria. DLTs include Grade (G) >3 neutropenia for ≥7 days; G 3 or 4 neutropenia with fever; G 4 anemia not related to cancer-associated bleeding; G 4 thrombocytopenia or G 3 with clinically significant bleeding; G ≥3 nausea or vomiting >48 hours despite anti-emetics; G 2 cystitis not resolved within 14 days; second G 2 cystitis; G 3 or 4 cystitis; diarrhea requiring dose reduction; Any other non-hematologic toxicity G ≥3 requiring a dose reduction (G ≥3 infusion-related reactions were not a DLT unless they recur despite slowing down the infusion); Other CRLX101 related treatment emergent adverse effect (TEAE) that requires patient withdrawal prior to completing all doses; Radiotherapy interruption due to TEAEs ≥5 days; or Dose interruption or reduction of capecitabine due to TEAE that results in <50% of the scheduled capecitabine dose for entire course|12 weeks|Since this objective applies only to Phase Ib patients, the Phase II cohort patients were not included|||mg/m^2 every other week|||Number
2614480|NCT02010359|Secondary|Change in Ratio of Adipose Tissue Macrophage Subpopulation|Ratio of M1 to M2 macrophages in adipose by flow cytometry at baseline and after 8 weeks Lovaza/placebo will be compared|Baseline and 8 weeks|4 participants did not sufficient adipose tissue from biopsy for flow cytometry analysis|||ratio||Standard Deviation|Mean
2614481|NCT02010359|Secondary|Change in mRNA Levels of TNFalpha in Adipose|relative mRNA quantification (fold change) from baseline to 8 weeks of treatment in Lovaza vs. placebo groups, as measured by RT-PCR|Baseline and 8 weeks|4 subjects did not have sufficient adipose tissue from biopsy for RT-PCR|||fold change||Standard Deviation|Mean
2614482|NCT02010359|Secondary|Change in mRNA Levels of IL6 in Adipose|relative mRNA quantification (fold change) from baseline to 8 weeks of treatment in Lovaza vs. placebo groups, as measured by RT-PCR|Baseline and 8 weeks|4 participants did not have sufficient adipose tissue from biopsy for RT PCR|||fold change||Standard Deviation|Mean
2614483|NCT02010359|Secondary|Change in mRNA Levels of MCP-1 in Adipose|relative mRNA quantification (fold change) from baseline to 8 weeks of treatment in Lovaza vs. placebo groups, as measured by RT-PCR|Baseline and 8 weeks|4 participants did not have sufficient adipose tissue in biopsy for RT-PCR|||fold change||Standard Deviation|Mean
2614484|NCT02010359|Secondary|Change in mRNA Expression of Fractalkine in Adipose|relative mRNA quantification (fold change) from baseline to 8 weeks of Lovaza/placebo will be compared in each subject|Baseline and 8 weeks|There were 4 participants that did not have sufficient adipose tissue in the biopsy for RT-PCR|||fold change||Standard Deviation|Mean
2614485|NCT02010359|Secondary|Change in the Ratio of Circulating Monocyte Subpopulations|Ratio of inflammatory CX3CR1lowCCR2+ to less inflammatory CX3CR1hiCCR2- monocytes by flow cytometry at baseline and after 8 weeks of Lovaza/placebo will be compared|baseline and 8 weeks||||ratio||Standard Deviation|Mean
2614486|NCT02010359|Secondary|Change in Plasma Tumor Necrosis Factor Alpha (TNFalpha)|Quantification of plasma TNFalpha at baseline and after 8 weeks of Lovaza/placebo will be compared|Baseline and 8 weeks||||pg/ml||Standard Deviation|Mean
2614487|NCT02010359|Secondary|Change in Plasma Monocyte Chemotactic Protein-1 (MCP-1)|Quantification of plasma MCP-1 at baseline and after 8 weeks of Lovaza/placebo will be compared|Baseline and 8 weeks||||pg/ml||Standard Deviation|Mean
2614488|NCT02010359|Secondary|Change in Plasma Interleukin 6 (IL-6)|Quantification of plasma IL-6 at baseline and after 8 weeks of Lovaza/placebo will be compared.|Baseline and 8 weeks||||pg/ml||Standard Deviation|Mean
2614489|NCT02010359|Primary|Change in Plasma Fractalkine Levels|Quantification of fractalkine levels in plasma at baseline and after 8 weeks of Lovaza or placebo will be compared.|Baseline and 8 weeks||||ng/ml||Standard Deviation|Mean
2614490|NCT02010255|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score|CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline.|Baseline to Posttreatment Week 4|Full Analysis Set. Cirrhotic participants were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.|||percentage of participants|||Number
2614530|NCT02010203|Secondary|Disease-free Survival at 3, 6, 18, and 24 Months|Evaluate Disease Free Survival at 3, 6, 18 and 24 months|Up to 2 years|Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.|||participants|||Number
2620540|NCT01954160|Secondary|Kansas City Cardiomyopathy Questionnaire Score||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2614491|NCT02010255|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score|Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.|Baseline to Posttreatment Week 4|Full Analysis Set. Participants with cirrhosis were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.|||percentage of participants|||Number
2614492|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 12||Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2614493|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2614494|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2614495|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2614496|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2614497|NCT02010255|Secondary|HCV RNA Levels and Change From Baseline at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2614498|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 24||Week 24|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.|||Percentage of participants|||Number
2614499|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 20||Week 20|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.|||Percentage of participants|||Number
2614500|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 16||Week 16|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.|||Percentage of participants|||Number
2614501|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.|||Percentage of participants|||Number
2614502|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.|||Percentage of participants|||Number
2614503|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 6||Week 6|Participants in the Full Analysis Set with available data were analyzed.|||Percentage of participants|||Number
2614504|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.|||Percentage of participants|||Number
2614505|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Full Analysis Set|||Percentage of participants|||Number
2614506|NCT02010255|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 1||Week 1|Full Analysis Set|||Percentage of participants|||Number
2614507|NCT02010255|Secondary|Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12|pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant.|Posttreatment Week 12|Participants who had a liver transplant while on study were analyzed if their last observed HCV RNA measurement prior to transplant was < LLOQ. Participants who received a transplant from an HCV-infected donor were excluded from analysis.|||Percentage of participants|||Number
2614508|NCT02010255|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set. Participants were excluded from the analysis if they received a liver transplant while on study (with HCV RNA <LLOQ at transplant) prior to lower bound of Posttreatment Week 12 visit window.|||Percentage of participants|||Number
2614509|NCT02010255|Secondary|Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)|SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Full Analysis Set. Participants in Cohort A and 1 participant in Cohort B who received a liver transplant prior to the lower bound of the Posttreatment Week 24 visit were not included in the analysis.|||Percentage of participants|||Number
2614510|NCT02010255|Secondary|Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)|SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment.|Posttreatment Week 8|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 8 visit were not included in the analysis.|||Percentage of participants|||Number
2614511|NCT02010255|Secondary|Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 4 visit were not included in the analysis.|||Percentage of participants|||Number
2614512|NCT02010255|Secondary|Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)|SVR2 was defined as HCV RNA < LLOQ at 2 weeks after stopping study treatment.|Posttreatment Week 2|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 2 visit were not included in the analysis.|||percentage of participants|||Number
2620541|NCT01954160|Secondary|6 Minute Walk Test||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2614514|NCT02010255|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least one dose of study drug. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 12 visit were not included in the analysis.|||percentage of participants|||Number
2614515|NCT02010216|Primary|Safety: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A SAE was any experience that suggested a significant hazard, contraindication, side effect or precaution that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|12 weeks|Safety population included all participants who received study drug.|||participants|||Number
2614516|NCT02010216|Primary|Percentage of Participants Achieving ACR20/50/70 Responses After the Third Infusion Categorized by Highest Response Achieved|American College of Rheumatology (ACR) ACR20, ACR50 or ACR70 response is defined as a ≥ 20% or 50% or 70% improvement (reduction) compared with Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Week 12|Intent-to-treat population included all participants.|||percentage of participants|||Number
2614517|NCT02010216|Primary|Change From Baseline in Disease Activity 28 (DAS28) Score|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Baseline, Week 12|Intent-to-treat population included all participants.|||score on a scale||Standard Deviation|Mean
2614518|NCT02010203|Secondary|Safety of the High Dose HS-410 Monotherapy|Phase 2 only Evaluate the safety of high dose vesigenurtacel-L monotherapy|Up to 3 years.|Data were not collected as pre-specified in Outcome Measure 17 due to study termination by the Sponsor.||||||
2614519|NCT02010203|Secondary|Safety of the Combination of the HS-410 and BCG|Phase 2 only Evaluate the safety of the combination of vesigenurtacel-L and BCG|Up to 1 year|Data were not collected as pre-specified in Outcome Measure 16 due to study termination by the Sponsor.||||||
2614520|NCT02010203|Secondary|T Cell Receptor Sequencing of Peripheral Blood T Cells Before and During Treatment|Evaluation of tumor tissue obtained from repeat biopsy, if clinically indicated, for presence of TILs, T cell receptor sequencing of peripheral blood T cells before and during the course of treatment.|Up to 2 years|Data were not collected as pre-specified in Outcome Measure 15 due to study termination by the Sponsor.||||||
2614521|NCT02010203|Secondary|Tumor Infiltrating Lymphocytes (TILs)|Evaluation of tumor tissue obtained from repeat biopsy, if clinically indicated, for presence of TILs|Up to 3 years|Data were not collected as pre-specified in Outcome Measure 14 due to study termination by the Sponsor.||||||
2614522|NCT02010203|Secondary|Tumor Antigen Expression|Evaluation of pre-treatment tumor tissue for antigen expression|At screening|Data were not collected as pre-specified in Outcome Measure 13 due to study termination by the Sponsor.||||||
2614523|NCT02010203|Secondary|Total PBMC Counts by Flow Cytometry|Evaluate total PBMC counts by flow cytometry, including lymphocyte subsets (B cells, helper T-cells, cytotoxic T-cells, natural killer (NK) cells and T-reg)|Up to 3 years|Data were not collected as pre-specified in Outcome Measure 12 due to study termination by the Sponsor.||||||
2614524|NCT02010203|Secondary|Immunologic Response of Peripheral Blood Mononuclear Cells (PBMCs) and Stimulation Analysis Via ICS in Baseline and Post-treatment Biopsies, if Clinically Indicated|Evaluate immunologic response of PBMCs (analysis of surface markers, CD3, CD4, CD8, CD19, CD25, CD45, CD56, FoxP3, and degranulation) and stimulation analysis via ICS of interferon gamma (IFNγ) and granzyme B (gzB)|Up to 3 years|Data were not collected as pre-specified in Outcome Measure 11 due to study termination by the Sponsor.||||||
2614525|NCT02010203|Secondary|Immunologic Response of PBMCs Via Intracellular Cytokine Staining (ICS) by Flow Cytometry and/or Enzyme-linked Immunosorbent Spot (ELISPOT) on CD8+ Cells After HS-410 Vaccination as Compared to Baseline.|Evaluate the proportion of patients with immunologic response of peripheral blood mononuclear cells (PBMCs) via intracellular cytokine staining (ICS) by flow cytometry and/or ELISPOT on CD8+ cells following vesigenurtacel-L vaccination|Up to 2 years|Data were not collected as pre-specified in Outcome Measure 10 due to study termination by the Sponsor.||||||
2614526|NCT02010203|Secondary|Proportion of Patients Undergoing Cystectomy by 12 and 24 Months|Evaluate the proportion of patients undergoing cystectomy by 12 and 24 months from randomization|Up to 2 years|Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.|||participants|||Number
2614527|NCT02010203|Secondary|Proportion of Patients Undergoing Repeat Transurethral Resection of Bladder Tumor (TURBT) by 12 and 24 Months||Up to 2 years|Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.|||participants|||Number
2614528|NCT02010203|Secondary|Overall Survival, Expressed as the Number of Participants Alive|Evaluate overall survival (OS)|Up to 3 years|Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.|||participants|||Number
2614531|NCT02010203|Secondary|Proportion of Patients With Progressive Disease at 3, 6, 12, 18, and 24 Months|Evaluate the proportion of patients with progressive disease at 3, 6, 12, 18, and 24|Up to 2 years|Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.|||participants|||Number
2614532|NCT02010203|Secondary|Proportion of Patients With Recurrence at 3, 6, 12, 18, and 24 Months|Evaluate the proportion of patients with recurrence at 3, 6, 12, 18, and 24 months|Up to 2 years|Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.|||participants|||Number
2614533|NCT02010203|Primary|Phase 2: 1-year Disease-Free Survival|"Arm 1, 2, 3: 1-year DFS in patients with NMIBC treated with BCG in combination with blinded study product (one of two doses of vesigenurtacel-L or placebo) Arm 4: 1-year DFS in patients with NMIBC treat1fv 9 with high dose vesigenurtacel-L monotherapy~One-year disease-free survival will be defined as the proportion of patients who are free from recurrent disease, progressive disease, and alive one year after the date of randomization/treatment assignment"|One year|Phase I is not applicable since the Outcome Measure is solely for Phase II; as pre-specified, only Phase II data would be collected.|||Participants|||Count of Participants
2614534|NCT02010203|Primary|Phase 1: Safety and Tolerability|To evaluate the safety and tolerability of vesigenurtacel-L|Up to 3 years.||||Participants|||Count of Participants
2614535|NCT02010151|Secondary|Number of Participants With Good Neurological Recovery|Cerebral performance category 1 or 2 is defined as good neurological recovery. we compared the good neurological recovery rate between before intervention period and intervention period.|discharge time from first admission from emergency department within 2 month||||Participants|||Count of Participants
2614536|NCT02010151|Secondary|Number of Participants With Pre-Hospital Return of Spontaneous Circulation (ROSC)|we compared the Pre-hospital return of spontaneous circulation (ROSC) rate between before intervention period and intervention period.|hospital arriving time from ambulance within 2 hours||||Participants|||Count of Participants
2614537|NCT02010151|Primary|Number of Participants Surviving at Hospital Discharge|"we compared the survival to discharge rate between before intervention period and intervention period.~Survival to discharge checked at the discharge point of hospital."|discharge time from first admission from emergency department within 2 month|Study population excluding exclusion criteria|||Participants|||Count of Participants
2614538|NCT02010021|Secondary|Percentage of Ki67 Score|"The Secondary Endpoint is to compare tumor cell proliferation as measured with the Ki-67 assay in breast cancer specimens taken before and at the time of surgery, comparing specimens of patients treated with presurgical letrozole and specimens of patients who did not receive presurgical letrozole. The secondary endpoint is Ki67 score, as determined by the percentage of Ki67+ tumor cells identified by immunohistochemistry.~Whole slides were scanned at 40x (Aperio AT2, Leica Biosystems), and automated Ki67 analysis (percent positive nuclei) was determined using the Aperio ImageScope (v12.3.1.60002, Leica Biosystems) nuclear v9 algorithm. As recommended by the International Ki67 in Breast Cancer Working Group, 3 high-power microscopic fields were selected for analysis to represent the spectrum of staining present on the whole tissue section, and a minimum of 500 malignant invasive cells were score"|baseline and surgery, approximately 30 days||||change in % of Ki67+ tumor cells||Full Range|Mean
2614539|NCT02010021|Primary|Change in Insulin Receptor Substrate 1 (IRS-1) / Phosphoinositide 3-kinase (PI3K) / Serine-threonine Protein Kinase (AKT) Pathway Activation|The Primary Endpoint is to determine the effect of ex vivo mTORC1 inhibition with everolimus (RAD001) on IRS-1/PI3K/AKT pathway activation (as measured by phospho-AKT-T308 and phospho-AKT-S473) in ER+/human epidermal growth factor receptor 2 (HER2)- breast tumors treated with presurgical letrozole compared to ER+/HER2- breast tumors not treated with presurgical therapy.|baseline and surgery, approximately 30 days||||% change||Standard Deviation|Mean
2614540|NCT02009982|Secondary|Incidence of Serious Adverse Events|The secondary endpoint for this study will be the incidence of serious adverse events related to the study procedure within the 12 month follow-up protocol|12 Months|No data was analyzed due to low enrollment.||||||
2614541|NCT02009982|Primary|Syncope Recurrence Rate|The primary endpoint for the study is recurrence of syncope within the 12 month follow-up protocol|12 Months|No data was analyzed due to low enrollment.||||||
2614542|NCT02009878|Secondary|Change From Baseline in Cumulative Urine Volume at 0-6 Hours, 0-12 Hours and 0-24 Hours.|Urine was collected for baseline comparison on Day 0 for the 24 hour prior to Day 1 dosing at intervals of 0 to 2, 2 to 4, 4, to 6, 6, to 8, 8, to 12, and 12 to 24 hours relative to Day 1 dosing time. Urine was collected on Day 1 at intervals of 0 to 2,2 to 4, 4 to 6, 6 to 8, 8 to 12, and 12 to 24 hours postdose. For the start of the urine collection on Day 0, a window of 15 to 40 minutes prior to the assigned dosing time was acceptable, with the 0 to 24 hour collection period on Day 1 starting 24 hours after the start time on Day 0. Participants were asked to void immediately prior to the end of the collection interval. The volume of individual voids were measured and recorded prior to refrigerating. All voids in a collection interval were pooled at the end of the collection interval, at which time the volume was determined, recorded and an aliquot taken for osmolality, sodium, potassium, and creatinine assessments.|2 days|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.|||mL||Standard Deviation|Mean
2614543|NCT02009878|Secondary|Change From Baseline in Fluid Balance (Fluid Intake Minus Urine Output) From 0-6 Hours, 0-12 Hours and 0-24 Hours.|Fluid intake was monitored on Day 0 (times relative to Day 1 dosing), and Day 1 at intervals of 0 to 6, 6 to 12, and 12 to 24 hours postdose. Fluid intake included fluid used for dosing (study medication and any concomitant medication); food items that included any significant amounts of water (e.g., Jello [including Gelatin and Jelly dessert] and soup) was added to the total fluid intake. Urine was collected for baseline comparison on Day 0 for the 24 hour prior to Day 1 dosing at intervals of 0 to 2, 2 to 4, 4 to 6, 6 to 8, 8 to 12 hours, and 12 to 24 hours relative to the Day 1 dosing time. Fluid balance was determined as fluid intake minus urine output.|2 days|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.|||mL||Standard Deviation|Mean
2614559|NCT02009722|Secondary|Nausea|Patients will be evaluated by a member of the study team at 12 hours after spinal administration. The number of patients with moderate or severe nausea will be recorded.|12 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis|||participants|||Number
2614544|NCT02009878|Secondary|Change From Baseline in Fluid Intake From 0-6 Hours, 0-12 Hours and 0-24 Hours|Fluid intake was monitored on Day 0 (times relative to Day 1 dosing), and Day 1 at intervals of 0 to 6, 6 to 12, and 12 to 24 hours postdose. Fluid intake included fluid used for dosing (study medication and any concomitant medication); food items that included any significant amounts of water (e.g., Jello [including Gelatin and Jelly dessert] and soup) was added to the total fluid intake. Samples were taken on Day 0 (baseline) at the corresponding Day 1 predose time and 12 hours postdose time; and on Day 1 at predose and at 2, 4, 6, 8, 12, and 24 hours postdose.|Baseline and Day 2|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.|||mL||Standard Deviation|Mean
2614545|NCT02009878|Primary|Time of Maximal Increase From Baseline in Serum Sodium Concentration Following Tolvaptan Administration.|Time of maximal increase in serum sodium is summarized in the table below by tolvaptan dose. Samples were taken on Day 0 (baseline) at the corresponding Day 1 predose time and 12 hours postdose time; and on Day 1 at predose and at 2, 4, 6, 8, 12, and 24 hours postdose.|Baseline to Day 2|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.|||hours||Full Range|Median
2614546|NCT02009878|Secondary|Change From Baseline in Serum Sodium Concentrations|Samples were taken on Day 0 (baseline) at the corresponding Day 1 predose time and 12 hours postdose time; and on Day 1 at predose and at 2, 4, 6, 8, 12, and 24 hours postdose.|Baseline and Day 2|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.|||mmol/L||Standard Deviation|Mean
2614547|NCT02009878|Secondary|AUC Infinity (Area Under the Concentration-time Curve From Time Zero to Infinity) for Tolvaptan in Plasma|Blood samples for determination of plasma concentrations of tolvaptan were collected predose and 1, 2, 3, 4, 8, 12, 16, and 24 hours postdose on Day 1 or at ET. If an indwelling catheter was utilized, saline flushes were used. PK parameters in participants with SIADH following tolvaptan administration for three different doses are presented below.|Baseline to Day 2|PK parameter dataset comprised of all participants who had taken 1 dose of study medication and had evaluable PK data.|||ng·h/mL||Standard Deviation|Mean
2614548|NCT02009878|Secondary|Tmax (Time to Maximum (Peak) Plasma Concentration) for Tolvaptan in Plasma|Blood samples for determination of plasma concentrations of tolvaptan were collected predose and 1, 2, 3, 4, 8, 12, 16, and 24 hours postdose on Day 1 or at ET. PK parameters in participants with SIADH following tolvaptan administration for three different doses are presented below.|Baseline to Day 2|PK parameter dataset comprised of all participants who had taken 1 dose of study medication and had evaluable PK data.|||hours||Full Range|Median
2614549|NCT02009878|Secondary|Cmax (Maximum (Peak) Plasma Concentration) for Tolvaptan in Plasma.|Blood samples for determination of plasma concentrations of tolvaptan were collected predose and 1, 2, 3, 4, 8, 12, 16, and 24 hours postdose on Day 1 or at ET. PK parameters in participants with SIADH following tolvaptan administration for three different doses are presented below.|Baseline to Day 2|PK parameter dataset comprised of all participants who had taken 1 dose of study medication and had evaluable PK data.|||ng/mL||Standard Deviation|Mean
2614550|NCT02009878|Primary|Maximal Increase From Baseline in Serum Sodium Concentration Following Tolvaptan Administration.|Maximal increase in serum sodium is summarized below by tolvaptan dose. Blood samples for determination of plasma concentrations of tolvaptan were collected predose and at 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours postdose on Day 1 or at Early Termination (ET).|Baseline to Day 2|PD dataset comprised of all participants who had taken 1 dose of study medication and had all observed measurements.|||mmol/L||Standard Deviation|Mean
2614551|NCT02009865|Secondary|Percent Change in Triglyceride(mg/dL) in Subjects With Biochemically Defined Fredrickson Type V (Triglyceride/Very-Low-Density Lipoprotein Cholesterol ≥6)|This secondary endpoint in subjects with Biochemically Defined Fredrickson Type V (Triglyceride/Very-Low-Density Lipoprotein Cholesterol ≥6), together with the 2nd. and 3rd.secondary ones, was treated as the core secondary, and the p value from the hypothesis test on its treatment comparison was adjusted by using Hommel's procedure.|From Baseline to Week 12 Endpoint|FAS|||Percentage of change (%)||Inter-Quartile Range|Median
2614552|NCT02009865|Secondary|Percent Change in High-Density Lipoprotein Cholesterol (mg/dL)|This secondary endpoint, together with the 2nd. and 4th. secondary ones, was treated as the core secondary, and the p value from the hypothesis test on its treatment comparison was adjusted by using Hommel's procedure.|From Baseline to Week 12 Endpoint|FAS|||Percentage of change (%)||Inter-Quartile Range|Median
2614553|NCT02009865|Secondary|Percent Change in Non-High-Density Lipoprotein Cholesterol (mg/dL)|This secondary endpoint, together with the 3rd. and 4th secondary ones, was treated as the core secondary, and the p value from the hypothesis test on its treatment comparison was adjusted by using Hommel's procedure.|From Baseline to Week 12 Endpoint|FAS|||Percentage of change (%)||Inter-Quartile Range|Median
2614554|NCT02009865|Secondary|Percent Change in Triglycerides for Subjects With at Least 1 Qualifying Triglyceride >885 mg/dL|This first secondary endpoint in subjects with at least 1 qualifying triglyceride >885 mg/dL was tested in parallel together with the primary endpoint, each at 0.025 Type I error rate.|From Baseline to Week 12 Endpoint|FAS|||Percentage of change (%)||Inter-Quartile Range|Median
2614555|NCT02009865|Primary|Percent Change in Triglyceride for All Subjects|This primary endpoint was tested in parallel together with the first of the secondary endpoints, each at 0.025 Type I error rate.|From Baseline to Week 12 Endpoint|Full Analysis Set (FAS)|||Percentage of change (%)||Inter-Quartile Range|Median
2614556|NCT02009722|Secondary|Treatment for Pruritus|The number of patients needing medical treatment for pruritus in first 24 hours after surgery|First 24 hours after spinal|only patients receiving most commonly used doses of IT hydromorphone (50,75,100 mcg) and morphine (100,150 mcg)|||participants|||Number
2614557|NCT02009722|Secondary|Treatment for Nausea|number of patients needing medication treatment for nausea in first 24 hours|First 24 hours|patients receiving most commonly used doses of IT medication (50,75,100 mcg for hydromorphone; 100, 150 mcg for morphine)|||participants|||Number
2614558|NCT02009722|Secondary|Nausea|Patients will be evaluated by a member of the study team at 24 hours after spinal administration. The number of patients with moderate or severe nausea will be recorded.|24 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis|||participants|||Number
2620542|NCT01954160|Secondary|Plasma Aldosterone||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2614560|NCT02009722|Secondary|Pruritus|Patients will be evaluated by a member of the study team at 24 hours after spinal administration. The number of patients with moderate or severe pruritus will be recorded.|24 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis|||participants|||Number
2614561|NCT02009722|Secondary|Pruritus|Patients will be evaluated by a member of the study team at 12 hours after spinal administration. The number of patients with moderate or severe pruritus will be recorded.|12 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis|||participants|||Number
2614562|NCT02009722|Secondary|Side Effects: Sedation|Patients will be evaluated by a member of the study team at 6, 12, and 24 hours after spinal administration. The presence of sedation will be graded by the Richmond Agitation Sedation Scale. Patients with a score of (-)2 or lower on the Richmond were classified as being positive for sedation.|6, 12, and 24 hours after spinal administration||||participants|||Number
2614563|NCT02009722|Secondary|Side Effects: Nausea|Patients will be evaluated by a member of the study team at 6 hours after spinal administration. Patients with moderate or severe nausea will be recorded.|6 hours after spinal|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis|||participants|||Number
2614564|NCT02009722|Secondary|Side Effects: Pruritus|Patients will be evaluated by a member of the study team at 6 hours after spinal administration. The number of patients with moderate or severe pruritus will be recorded.|6 hours after spinal administration|The number of patients at the most commonly used doses of IT medication (50, 75, 100 mcg for hydromorphone) and (100, 150 mcg) for morphine were used in analysis|||participants|||Number
2614565|NCT02009722|Primary|Dose of IT Morphine and IT Hydromorphone for Adequate Analgesia (Pain Score Less Than or Equal to 3) in 90% of Patients|Each patient will be interviewed by a member of the study team 12 hours after receiving their spinal anesthetic (which will include either hydromorphone or morphine). Patients will be asked to rate their current level of pain on a scale of 0 (no pain) to 10 (worst pain imaginable). A pain score <4 will be considered a success. The up-down sequential allocation method will be used to determine the dose (mcg) of IT hydromorphone and IT morphine for subsequent patients|12 hours after administration of spinal anesthesia|The primary outcome was determining the optimal dose of IT morphine and IT hydromorphone for patients undergoing cesarean delivery. Study was designed to determine the ED90 (effective dose in 90% patients; effective dose meaning a VAS score for pain of 3 or less at 12 hours after spinal placement).|||micrograms|||Number
2614566|NCT02009696|Primary|Percentage of Participants Free of R-wave Sensing Attenuation|Evaluate the percentage of subjects who experience R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|Number of participants with a ventricular lead and same ventricular sensing polarity (either uni- or bi-polar) at pre-MRI and one-month post-MRI.|||percentage of participants||95% Confidence Interval|Number
2614567|NCT02009696|Primary|Percentage of Participants Free of P-wave Sensing Attenuation|Evaluate the percentage of subjects who experience P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|Number of participants with an atrial lead and same sensing polarity (either uni- or bi-polar) at pre-MRI and one-month post-MRI.|||percentage of participants||95% Confidence Interval|Number
2614568|NCT02009696|Primary|Percentage of Participants Free of Ventricular Pacing Threshold Rise|Evaluate the percentage of ventricular pacing leads with a pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|Number of participants with a ventricular lead and same ventricular threshold polarity (either uni- or bi-polar) at pre-MRI and one-month post-MRI.|||percentage of participants||95% Confidence Interval|Number
2614569|NCT02009696|Primary|Percentage of Participants Free of Atrial Pacing Threshold Rise|Evaluate the percentage of atrial pacing leads with a pacing threshold increaess between the Pre-MRI and one-month post-MRI follow-up.|Between Pre-MRI and 1 Month Post-MRI|Number of participants with an atrial lead and same atrial threshold polarity (either uni- or bi-polar) at pre-MRI and one-month post-MRI.|||percentage of participants||95% Confidence Interval|Number
2614570|NCT02009696|Primary|MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate||1 Month Post-MRI||||percentage of participants||95% Confidence Interval|Number
2614571|NCT02009501|Primary|Change in Bacteria Colony-forming Units Using When NPWT and NPWTi on Venous Leg Ulcers|Biopsies for bacteria colony-forming units obtained at pre surgical debridement (baseline) and day 7.|Baseline and day 7||||10^3 CFU/g||Standard Deviation|Mean
2614572|NCT02009163|Secondary|Total Scores For The Amphetamine Cessation Symptom Assessment (ACSA) Scale During Follow-up|The ACSA was used in this study to assess potential withdrawal symptoms associated with chronic use of SPD489. The ACSA is a self-completed scale used to assess withdrawal symptoms. The scale has 16 symptom items rated on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The ACSA total score ranges from 0-64, where a higher score indicates greater withdrawal symptom severity.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination) and Visit 22 (7 days post last dose)|The RSAS. Four (placebo) and one (SPD489) participants were randomized but not treated and thus not included in the RSAS. Visits 21 and 22 could include participants who discontinued but completed a final safety and efficacy assessment. Not all participants had data for this outcome.|||units on a scale||Standard Deviation|Mean
2614579|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.|||percentage of participants|||Number
2614573|NCT02009163|Secondary|Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Randomized-withdrawal Period|"The C-SSRS is a semistructured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answer to the first 2 ideation questions was yes, the clinician asked questions 3-5. Active suicidal ideation included any participant who answered yes to questions 2-5. If the answers to ideation questions 1 and 2 were No, then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide."|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The Randomized Safety Analysis Set (RSAS), defined as participants in the SAS who were randomized and took at least 1 dose of investigational product in the randomized-withdrawal period. Four (placebo) and one (SPD489) participants were randomized but not treated and thus not included in the RSAS. Three participants had no data for this outcome.|||participants|||Number
2614574|NCT02009163|Secondary|Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Open-label Period|"The C-SSRS is a semistructured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answer to the first 2 ideation questions was yes, the clinician asked questions 3-5. Active suicidal ideation included any participant who answered yes to questions 2-5. If the answers to ideation questions 1 and 2 were No, then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide."|Visit 8 (12 weeks after start of open-label treatment [Week 12])|The OSP. Three participants in the OSP did not have data collected for this outcome. Visit 8 included only participants who completed open-label treatment.|||participants|||Number
2614575|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.|||percentage of participants|||Number
2614576|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The OSP. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.|||percentage of participants|||Number
2614577|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not included in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.|||percentage of participants|||Number
2614578|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The OSP. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.|||percentage of participants|||Number
2614611|NCT02008890|Secondary|Percentage of Participants With Most Frequent Adverse Events - Period 2 (Patient's Safety)|Most frequent (at least 5% in any of the AIN457 groups) Adverse Events|Week 16 to Week 52 (Period 2)|Safety Set - Including only patients entering period 2|||percentage of participants|||Number
2614580|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The OSP. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.|||percentage of participants|||Number
2614581|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not included in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.|||percentage of participants|||Number
2614582|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The OSP. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.|||percentage of participants|||Number
2614583|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5--Dimension 5--Level Self--Report Questionnaire (EQ--5D--5L) For Mobility at Endpoint of The Randomized-withdrawal Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.|||percentage of participants|||Number
2614584|NCT02009163|Secondary|Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility at Endpoint of The Open-label Period|The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.|Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination)|The Open-label Safety Population (OSP), defined as participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.|||percentage of participants|||Number
2614585|NCT02009163|Secondary|Change From Randomized-Withdrawal Baseline in The Total Score of The Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) During The Randomized-withdrawal Period|The Y-BOCS-BE measures the obsession of binge eating thoughts and compulsiveness of binge eating behaviors. The scale is a clinician rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). The scale includes questions regarding the amount of time spent on obsessions, impairment or distress experienced, and resistance and control over these thoughts. The same types of questions were asked about compulsions (ie, time spent, interference, etc.).Total scores range from 0 to 40. A total score of 0-7 is sub-clinical, 8-15 is mild, 16-23 is moderate, 24-31 is severe, and 32-40 is extreme. A decrease from baseline in Y-BOCS-BE Total Score represents an improvement in obsession with binge-eating thoughts or compulsiveness of binge-eating behaviors.|Randomized-withdrawal baseline (Visit 8; 12 weeks after start of open-label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38])|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 included only participants who completed randomized treatment (placebo: n=54; SPD489: n=107).|||units on a scale||Standard Error|Least Squares Mean
2614586|NCT02009163|Secondary|Percent of Participants Within Each Category of The Clinical Global Impression-Severity of Illness (CGI-S) Scale at Endpoint of The Randomized-withdrawal Period|The CGI-S permits a global evaluation of a subject's condition and severity of symptoms. The CGI-S was performed to rate the severity of a subject's condition based on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.|||percentage of participants|||Number
2614587|NCT02009163|Secondary|Change From Randomized-Withdrawal Baseline in The Number of Binge- Eating Days Per Week During The Randomized-withdrawal Period|A binge day was defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary. Binge eating information was captured via a self-report paper diary. The binge diary captured the number of binges per day, total hours per day spent binging, type of binge (at mealtime or at another time other than mealtime), and a description of the binge (amounts and types of foods). Binge frequency was reviewed by the clinician with the subject to confirm reported binge episodes per day. A negative change from Baseline indicates that binge-related behavior decreased. The randomized -withdrawal-baseline was defined as the weekly average number of binge days for the 14 days prior to the Randomization Visit (Visit 8).|Randomized--withdrawal baseline (Visit 8; 12 weeks after start of open- label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38])|The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 included only participants who completed randomized treatment (placebo: n=50; SPD489: n=102).|||days||Standard Error|Least Squares Mean
2614588|NCT02009163|Primary|Time to Relapse From Date of Randomization to Endpoint of The Randomized-withdrawal Period|Relapse status was assessed during the double-blind treatment phase and was defined as having 2 or more binge days per week for 2 consecutive weeks (14 consecutive days) prior to any visit and having an increase in Clinical Global Impressions-Severity (CGI-S) score of 2 or more points compared to the randomized-withdrawal baseline (date of relapse - date of randomization). Binge eating information was captured via a self-report paper diary. The binge diary captured the number of binges per day, total hours per day spent binging, type of binge (at mealtime or at another time other than mealtime), and a description of the binge (amounts and types of foods). Binge frequency was reviewed by the clinician with the subject to confirm reported binge episodes per day. The CGI-S was performed to rate the severity of a subject's condition using a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).|Visit 21 (26 weeks after randomization [Week 38] or Early Termination)|The Full Analysis Set (FAS): participants in the Randomized Safety Analysis Set (RSAS) with at least 1 post-randomization CGI-S assessment. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.|||days||Inter-Quartile Range|Median
2614589|NCT02009046|Secondary|Percent of Participants Who Currently Have Condom|Between-arm difference in percent of youth who report currently having a condom with them (e.g., in a pocket, purse or backpack)|1 year|412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.|||percentage of participants|||Number
2614590|NCT02009046|Secondary|Percent of Participants Who Used Contraceptive at Last Sex|Between-arm difference in percent of youth who report using birth control and/or condoms the last time they had sexual intercourse|1 year|412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.|||percentage of participants|||Number
2614591|NCT02009046|Secondary|Percent of Participants Who Used Condom at Last Sex|Between-arm difference in percent of youth who report using a condom the last time they had sexual intercourse|1 year|412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.|||percentage of participants|||Number
2614592|NCT02009046|Secondary|Percent of Participants With Recent Oral Sex Activity|Between-arm difference in percent of youth who report engaging in oral sexual intercourse in the last 3 months|1 year|412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.|||percentage of participants|||Number
2614593|NCT02009046|Secondary|Percent of Participants With Recent Sexual Activity|Between-arm difference in percent of youth who report engaging in vaginal and/or anal sexual intercourse during the last 3 months|1 year|412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.|||percentage of participants|||Number
2614594|NCT02009046|Secondary|Percent of Participants Who Ever Had Oral Sex|Between-arm difference in percent of youth who report ever engaging in oral sexual intercourse|1 year|412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.|||percentage of participants|||Number
2614595|NCT02009046|Secondary|Percent of Participants Who Ever Had Sex|Between-arm difference in percent of youth who report ever engaging in vaginal and/or anal sexual intercourse|1 year|412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.|||percentage of participants|||Number
2614596|NCT02009046|Primary|Percent of Participants Who Ever Used Sexual and Reproductive Health Services|Between-arm difference in percent of youth who report ever using sexual and reproductive health services|1 year|412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.|||percentage of participants|||Number
2614612|NCT02008890|Secondary|Percentage of Participants With Most Frequent Adverse Events - Period 1 (Patient's Safety)|Most frequent (at least 5% in any of the AIN457 groups) Adverse Events|Baseline to Week 16 (Period 1)|Safety Set|||percentage of participants|||Number
2614597|NCT02009046|Primary|Percent of Participants With Multiple Sexual Partners|Between-arm difference in percent of youth who report having more than one recent vaginal, anal and/or oral sexual partner|1 year|412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.|||percentage of participants|||Number
2614598|NCT02009046|Primary|Percent of Participants With Sexually Transmitted Infection (STI) Risk|Between-arm difference in percent of youth who report engaging in recent vaginal, anal and/or oral sexual intercourse but not using condoms|1 year|412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.|||percentage of participants|||Number
2614599|NCT02009046|Primary|Percent of Participants With Pregnancy Risk|Between-arm difference in percent of youth who report engaging in recent sexual intercourse but not using birth control and/or condoms|1 year|412 participants completed the SEI Curriculum + 3 School Wide Components Arm/Group and 329 completed the Control Curriculum + 1 School Wide Component Arm/Group. Small fractional inconsistencies in reported and calculated outcome results are due to missing data and/or rounding of percentages.|||percentage of participants|||Number
2614600|NCT02008942|Primary|Time to 99% Inhibition of Serum Thromboxane|Serial measurements of aspirin anti-platelet activity will be collected over 11 days, and compared between groups, to allow a determination of pharmacodynamic (anti-platelet) bioequivalence between study drugs. Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy.|11 days|Pharmacodynamic (PD) Evaluable Population - patients in the intent-to-treat population who received a full treatment regimen for each of 2 study drugs, had all scheduled PD blood draws, and had no other major protocol violations.|||hours||Standard Deviation|Mean
2614601|NCT02008916|Secondary|ASAS Partial Remission|ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale of 10. In this study, ASAS partial remission was used to assess the efficacy of at least one dose of secukinumab versus placebo.|16 weeks|FAS - Missing ASAS responses were considered as non-responder|||Participants|||Count of Participants
2614602|NCT02008916|Secondary|Prefilled Syringe Patient Satisfaction Assessment|The self-injection assessment questionnaire (SIAQ) measures overall patient experience with subcutaneous self-injection at applicable visits. Domain scores ranging from 0 (worst experience) to 10 (best experience) are presented: Feeling about injections, Self-confidence, Satisfaction with self-injection.|Baseline, weeks 8, 12 and 16|Safety Set|||Points||Standard Deviation|Mean
2614603|NCT02008916|Secondary|Pre-filled Syringe Possible Hazard|The number and percentage of subjects who experience any of the defined possible hazards are summarized, as defined in the Possible Hazard assessment check list and as observed by the site staff at applicable visits.|Week 8 and Week 12|Safety Set|||Participants|||Count of Participants
2614604|NCT02008916|Secondary|Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe)|Successful self-administration is defined as success in steps P8 (Removed Needle Cap from Safety Syringe), P10 (Pinched the Skin at Injection Site), P11 (Inserted the Needle into Skin), P12 (Held onto the Finger Flange), P13 (Fully Depressed Plunger until End Point), and P14 (Held Plunger Down and Syringe in Place) of the Instructions for Use, as observed by the site staff at applicable visits.|Week 8 and Week 12|Safety Set|||Participants|||Count of Participants
2614605|NCT02008916|Secondary|Bath Ankylosing Spondylitis Disease Activity Index / BASDAI|"BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating no problem and 10 indicating worst problem), to characterise six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI index was used to assess the efficacy of at least one dose of secukinumab versus placebo."|Baseline and 16 weeks|FAS|||units on a scale||Standard Deviation|Mean
2614606|NCT02008916|Secondary|ASAS 5/6 Response|ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevant to AS and no worsening in the remaining domain. In this study, ASAS 5/6 was used to assess the efficacy of at least one dose of secukinumab versus placebo.|16 weeks|FAS - Missing ASAS responses were considered as non-responder|||Participants|||Count of Participants
2614607|NCT02008916|Secondary|Serum hsCRP|Blood levels of C-reactive protein (CRP), an acute phase reactant, are indicative of inflammation and of its severity, and can be used to monitor treatment response. A high sensitivity CRP (hsCRP) test was implemented in this study, to assess the efficacy of at least one dose of secukinumab versus placebo in reducing AS elicited systemic inflammation over the time.|Baseline and 16 weeks|FAS|||mg/L||Standard Deviation|Mean
2614608|NCT02008916|Secondary|ASAS 40 Response|ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 was used to assess the efficacy of at least one dose of secukinumab versus placebo.|16 weeks|FAS - Missing ASAS responses were considered as non-responder|||Participants|||Count of Participants
2614609|NCT02008916|Primary|Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response|ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 was used to assess the efficacy of at least one dose of secukinumab versus placebo.|16 weeks|FAS - Missing ASAS responses were considered as non-responder|||Participants|||Count of Participants
2614610|NCT02008890|Secondary|Percentage of Participants With Most Frequent Adverse Events - Extension Period (Patient's Safety)|Most frequent (at least 5% in any of the AIN457 groups) Adverse Events|Week 52 to Week 148 (extension period)|Safety Set - including only patients entering the extension period|||percentage of participants|||Number
2614613|NCT02008890|Secondary|Percentage of Participants With ppPASI 75 Response Over Time (Extension Period)|A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to each post-baseline visit was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.|Week 52 to Week 148|FAS - Including only patients entering extension period (Placebo Week 16 responders not eligible)|||percentage of participants|||Number
2614614|NCT02008890|Secondary|Percentage of Participants With ppPASI 75 Response Over Time (Period 2)|A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.|Week 16 to Week 52|FAS - Including only patients entering period 2|||percentage of participants|||Number
2614615|NCT02008890|Secondary|Percentage of Participants With ppPASI 75 Response Over Time (Period 1)|A secondary endpoint was assessed as response rate of patients to treatment measured by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieve a 75% reduction in ppPASI score from Baseline to each post-baseline visit is measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.|Baseline to Week 16|FAS|||percentage of participants|||Number
2614616|NCT02008890|Secondary|ppPASI: Absolute Change From Baseline to Week 16|A secondary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index (ppPASI). The mean change of ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.|Baseline to Week 16|FAS - Including only Patients with ppPASI Scores at Baseline and Week 16|||units on a scale||Standard Deviation|Mean
2614617|NCT02008890|Primary|Percentage of Participants With ppPASI 75 Response at Week 16 (Period 1)|The primary endpoint was assessed by the palmoplantar pustulosis Psoriasis Area and Severity Index 75 (ppPASI 75). The percentage of subjects who achieved a 75% reduction in ppPASI score from Baseline to Week 16 was measured. The ppPASI is a modification of the PASI score and adjusted for palmoplantar pustular psoriasis by classifying and scoring erythema, scaling (desquamation) and pustules/vesicles. Both palms and both plants are scored from 0 to 4. The extent of involvement of each region of the body is scored from 0 to 6. The total ppPASI score can range from a lower level of 0, corresponding to no signs of psoriasis, up to a maximum of 72.|Baseline to Week 16|Full Analysis Set (FAS = Started). A patient with a missing ppPASI assessment at Week 16 was considered as a responder if he/she has met the response criterion already at the time of drop-out. Otherwise he/she was considered as a non-responder.|||percentage of participants|||Number
2614618|NCT02008877|Secondary|Determine Maximum Tolerated Dose (MTD)/Recommended Dose (RD) of Ganetespib|A conventional 3+3 dose escalation design was used for phase 1. All patients in phase 2 were treated with the recommended dose.|Phase 1 of study|1 patient was inevaluable in Phase 1 of study. The recommended dose of ganetespib was determined to be 200 mg/m2 intravenously on days 1, 8, 15 with sirolimus 4mg orally once daily with a cycle 1 day 1 loading dose of 12mg. All patients in phase 2 were treated with the recommended dose.|||Participants|||Count of Participants
2614619|NCT02008877|Secondary|Plasma Pharmacokinetic Profile of Ganetespib When Administered in Combination With Sirolimus|To describe the plasma pharmacokinetic profile of ganetespib in terms of half life.|Cycle 1 Day 15|10 patients were enrolled in Phase 1 of the study. 1 patient was inevaluable.|||hours||Standard Deviation|Mean
2614620|NCT02008877|Secondary|Utility of Three-dimensional MRI (3D-MRI) Analysis in Comparison to 1-dimensional and 2-dimensional Measurements|To evaluate the utility of three-dimensional MRI (3D-MRI) analysis in comparison to 1-dimensional and 2-dimensional measurements as a method to more sensitively monitor response.|4 months|The 3D-MRI were not measurable with current modalities. Due to their nature and incomplete imaging, volumetric analysis was not feasible.||||||
2614621|NCT02008877|Secondary|Patient-reported Pain Severity and the Impact of Pain on Daily Activities|"To assess patient-reported pain severity and the impact of pain on daily activities before and during treatment with ganetespib and sirolimus. The Numerical Rating Scale-11 (NRS-11) will be used to assess pain severity. The NRS-11 is a self-report segmented 11-point numeric scale that assesses pain severity. It consists of a horizontal line with 0 representing no pain at the right end of the line and 10 representing worst pain you can imagine at the left end.The Brief Pain Inventory is a 7-item self-report questionnaire that measures the extent to which pain interferes with daily functioning. Patients are asked to indicate how much pain interfered with various activities in the past week, with scores ranging from 0 (does not interfere) to 10 (completely interferes). A total score is obtained by taking the mean of the scores for all 7 items; thus, the total pain interference score can range from 0 to 10."|Baseline and prior to Cycle 3|Thirteen subjects in phase 1 and phase 2 cohorts combined had MPNST and completed the pain evaluations. 4/13 subjects completed both baseline and pre-cycle 3 evaluations for pain.|||units on a scale||Full Range|Mean
2614667|NCT02008318|Secondary|Change From Baseline in EuroQol 5-Dimension 5 Level Instrument|EuroQol 5-Dimension 5 Level Instrument (EQ-5D-5L) was not conducted, trial terminated prior to Phase 3. No data collected.|Phase 3: Baseline, Cycle 2, Cycle 4, Cycle 6 (Cycle = 28 days)|Participants who received at least one dose of study drug during Phase 3.||||||
2614622|NCT02008877|Secondary|Changes in Pharmacodynamic Parameters in Peripheral Blood Mononuclear Cells|To explore changes in pharmacodynamic parameters in peripheral blood mononuclear cells performed on day 1 prior to ganetespib and sirolimus administration, and on day 15, 6 hours post drug administration. Hsp inhibition (Hsp70), mTOR inhibition (phospho-S6 and Akt Phosphorylation), UPR activation (EIF2alpha phosphorylation) will be explored. Western blot analyses were performed for phospho (p)-Akt, p-eIF2α, p-S6, and Hsp70. The absorbance of each phosphoprotein lane was recorded and protein levels were determined after normalizing for levels of corresponding total protein.|Baseline and Cycle 1 Day 15|11 subjects provided consent and had adequate specimens for analysis.|||ratio||Standard Deviation|Mean
2614623|NCT02008877|Secondary|Change in Plasma Pharmacokinetic Profile of Ganetespib and Sirolimus When Administered in Combination-Observed Maximum Plasma Concentration (Cmax)|To describe the plasma pharmacokinetic profile of ganetespib and sirolimus when administered in combination therapy.|Pre-therapy levels drawn at baseline and pharmacokinetic analysis occurs on Cycle 1 Day 15|10 patients were enrolled in Phase 1 of the study. Three patients were enrolled in the first dose level. Six patients were enrolled at dose level 2. 1 patient was inevaluable.|||ng/mL||Standard Deviation|Mean
2614624|NCT02008877|Primary|Clinical Benefit of Ganetespib in Combination With Sirolimus|Assessed using the World Health Organization (WHO) criteria. Tumor assessments will be obtained every 2 cycles. Clinical benefit is defined as stable disease, Partial Response (PR), Complete Response (CR). For patients who experience progression by WHO but in the opinion of the treating investigator are deriving benefit from therapy and have not otherwise met off treatment or off study criteria, may continue on treatment as long as patient has not met progression by RECIST 1.1.|Response evaluations will be performed after every 2 treatment cycles (each cycle=28 days)|10 patients were enrolled in Phase 1 and 10 patients were enrolled in Phase 2 of the study. Overall number of patients enrolled was 20.|||Participants|||Count of Participants
2614625|NCT02008877|Primary|Number of Dose Limiting Toxicities of Ganetespib When Administered in Combination With Sirolimus.|To assess the safety, tolerability, and maximum tolerated/ recommended dose of ganetespib when administered in combination with sirolimus in patients with refractory sarcomas or unresectable or metastatic sporadic or neurofibromatosis type 1 (NF1) associated MPNST. Toxicities observed during the first cycle will be used to define the MTD/Recommended dose. Toxicity will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. DLT will be defined as any of the following events that are possibly, probably, or definitely attributable to ganetespib or sirolimus. The DLT observation period for the purposes of dose escalation will be the first cycle of therapy.|Toxicities will be evaluated over the first treatment cycle (each cycle=28 days)|10 patients were enrolled in Phase 1 of the study to determine MTD/RD. Three patients were enrolled in the first dose level. Six patients were enrolled at dose level 2. 1 patient was inevaluable.|||DLTs|||Number
2614626|NCT02008773|Secondary|Functional Performance|To evaluate the efficacy of adjunctive valacyclovir, compared to placebo, to improve to improve global functional assessments as measured by the Clinical Global Impressions Severity Scale (CGI-S). The CGI-S is a single 7-point Likert scale rating severity of psychopathology on a scale of 1 (normal, not ill) to 7 (very severely ill).|Baseline, 8 weeks, and 16 weeks||||scores on a scale||Standard Error|Least Squares Mean
2614627|NCT02008773|Secondary|Psychosis Symptoms|To evaluate the efficacy of adj. valacyclovir for general and positive symptoms (sxs) as measured by the PANSS total and factor scores and negative sxs as measured by the NSA-16.The PANSS contains 30 items that assess sxs of psychotic d/os.Positive sxs are rated on 7 items, negative sxs on 7 items, and general psych. on 16 items.Scores for each item range from 1-7.Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psych. scores ranging from 16-112.Total scores for all items range from 30-210.Additionally a factor score can be derived for Cognition/Disorganization by using scores from 7 items and ranges from 7-49.For factor and total scores a lower score reflects fewer sxs.The NSA-16 is used to rate behaviors commonly associated with negative sxs of schizophrenia.The scale rates subjects on 16 anchors from 1 to 6.The total score is the sum of the 16 specific items and ranges from 16 to 96; a higher score indicates greater severity of illness.|Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks||||Symptom Scale Scores||Standard Error|Least Squares Mean
2614628|NCT02008773|Secondary|Functional Performance|To evaluate the efficacy of adj. valacyclovir to improve functional performance and quality of life (QOL) as measured by the UCSD Performance-Based Skills Assessment, Version B (UPSA-B); QOL Enjoyment and Satisfaction Questionnaire Short Form (Q-LES); and Personal and Social Performance Scale (PSP). The UPSA-B is a performance-based assessment of improvement in functional capacity.Participants are asked to role-play communication and finance tasks. Scores are assigned for each of the 2 subscales and formula is used to calculate a total score (0-100). A higher score reflects better performance. The Q-LES, 16 item scale yields a raw total score, ranging from 14-70, with a higher score representing higher QOL. The PSP scale is a single item scale assessing 4 domains of functioning: personal&social relationships, socially useful activities, self-care, and disturbing&aggressive behaviors. An adjusted score from 0-100 is generated, a higher score reflects better functioning.|Baseline, 8 weeks, and 16 weeks||||Scores on a Scale||Standard Error|Least Squares Mean
2614629|NCT02008773|Secondary|Cognitive Performance|To evaluate the efficacy of adjunctive valacyclovir, in comparison to placebo, to improve general cognitive performance as measured by the MATRICS Consensus Cognitive Battery composite score in HSV1 + and - participants. MCCB is comprised of 10 tests, Trail Making Test Part A; Brief Assessment in Cognition in Schizophrenia Symbol Coding; Hopkins Verbal Learning Test-Revised; Wechsler Memory Scale-III Spatial Span; Letter Number Sequencing; Neuropsychological Assessment Battery Mazes; Brief Visuospatial Memory Test-Revised; Category Fluency Animal Naming; Mayer-Salovey-Caruso Emotional Intelligence Test Managing Emotions; and Continuous Performance Test-Identical Pairs. For each test, a score is derived based on the raw item values. Each of the individual item raw scores is standardized to age and gender corrected tscores which are then summed to convert into a composite score ranging from <214->486 based on the MCCB scoring manual, with a higher score reflecting better performance.|Baseline, 8 Weeks, and 16 weeks||||MATRICS Composite Scores||Standard Error|Least Squares Mean
2614719|NCT02007863|Primary|Number of Successful Unrelated Cord Blood (UCB) Transplants|The number of patients who received successful UCB transplants as evidenced by absolute neutrophil recovery.|2 Years|THERE ARE NO SPECIFIC RESEARCH QUESTIONS IN THIS PROTOCOL. This protocol merely provides UCB as a stem cell treatment modality to pediatric patients who may require it after a conditioning regimen that excludes Total Body Irradiation.Unrelated Cord Blood (UCB) transplant|||participants|||Number
2614630|NCT02008773|Primary|Working Memory|"Determine the efficacy of adjunctive valacyclovir, in comparison to placebo, on working memory (composite score of the Wechsler Memory Scale-III: Spatial Span and Letter Number Span tests). WMS has 2 sections in which a subject recalls increasingly difficult sequences. The total raw score range for both sections is 0-32. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance.~LNS consists of 24 increasingly difficult sequences of letters and numbers that a subject is to recall and repeat back in Numeric-Alpha sequential order. The total raw score range is 0-24. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance. The Working Memory composite score is calculated by summing the WMS and LNS tscores, a higher tscore reflects better performance."|Baseline, 8 weeks, and 16 weeks||||Working Memory Scores||Standard Error|Least Squares Mean
2614631|NCT02008773|Primary|Visual Memory|"To determine the efficacy of adjunctive valacyclovir, in comparison to placebo, to improve visual memory (Brief Visuospatial Memory Test) in individuals who are HSV-1 positive and early in the course of schizophrenia. The Brief Visuospatial Memory Test is a subscale of the MATRICS Consensus Cognitive Battery (MCCB) and was used to assess visual memory.~The BVMT consists of three trials in which participants must recall shapes by drawing figures on a blank page after being given the opportunity to memorize the figures for 10 seconds. Each page consists of six figures. Points are awarded based on the accuracy of the drawn figure and by correct placement on the page. A minimum of 0 to 12 points are awarded per trial, so a participant can score between 0 and 36 points for all three trials. The raw score is then converted to a t-score, normed by age and sex. The min and max t-scores are between 0-100, a higher t-score representing a better outcome."|Baseline, 8 weeks, and 16 weeks||||visual memory scores||Standard Error|Least Squares Mean
2614632|NCT02008682|Secondary|Number of Confirmed Hypoglycaemic Episodes|confirmed hypoglycaemic episode defined as severe (unable to treat her/himself) or biochemically confirmed by a plasma glucose < 3.1 mmol/L|Weeks 0-26|Safety analysis set included all subjects receiving at least one dose of investigational product.|||episodes|||Number
2614633|NCT02008682|Secondary|Subjects Who Achieve (Yes/no) HbA1c Below or Equal to 6.5 % (American Association of Clinical Endocrinologists Target)|Calculated as the percentage of subjects achieving treatment target of HbA1c <= 6.5% at Week 26|After 26 weeks of treatment|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.|||percentage of subjects|||Number
2614634|NCT02008682|Secondary|Subjects Who Achieve (Yes/no) HbA1c Below 7.0 % (American Diabetes Association Target)|Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26|After 26 weeks of treatment|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.|||percentage of subjects|||Number
2614635|NCT02008682|Secondary|Change From Baseline in 7-point Self-measured Plasma Glucose Profile|Mean change from baseline in mean of 7-point self-measured plasma glucose at week 26. The 7-point self-measured plasma glucose levels were measured before and after (120 minutes after the start of the meal) the three main meals (breakfast, lunch and dinner), and at bed time.|Week 0, week 26|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.|||mmol/L||Standard Deviation|Mean
2614636|NCT02008682|Secondary|Change From Baseline in Fasting Plasma Glucose|Mean change from baseline in fasting plasma glucose (FPG) at Week 26.|Week 0, week 26|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.|||mmol/L||Standard Deviation|Mean
2614637|NCT02008682|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c)|Mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.|Week 0, week 26|Full analysis set was defined as all randomised and exposed subjects who had any post randomisation data. Missing data was imputed using a mixed model for repeated measurements. The subjects would not contribute to the analyses if they didn’t have a corresponding post-baseline value.|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
2614638|NCT02008617|Secondary|Quality of Recovery (QoR15)|"Quality of recovery (QoR15) is a questionnaire that asks 15 questions regarding how the participant has felt in the last 24 hours. Each question is followed by an 11-point numerical rating scale (0 = none of the time to 10 = all of the time; maximum score 150). The higher the QoR15 total score, the worse the quality of recovery reported."|24hrs||||units on a scale||Inter-Quartile Range|Median
2614639|NCT02008617|Secondary|Patient Satisfaction|Patient satisfaction with pain control scale ranges from 0 (no satisfaction) to 10 (very satisfied).|24hr||||units on a scale||Inter-Quartile Range|Median
2614640|NCT02008617|Secondary|Pain Score|Numeric Rating Scale (NRS) (NRS pain scores; 0 = no pain,10 = excruciating pain) in the back of the knee recorded every 4 hours up to 24hrs following surgery. Pain Bruden scale ranges from 0 (no pain) to 240 (extreme pain). For example, pain burden of 120 is equivalent to a NRS score of 5 out of 10.|Pain Burden at 24hrs||||units on a scale||Inter-Quartile Range|Median
2614641|NCT02008617|Primary|Opioid Consumption|Opioid consumption (mg morphine equivalents)|24 hours||||mg morphine equivalents||Inter-Quartile Range|Median
2614642|NCT02008565|Secondary|Change From Baseline Maximum Anal Pressures During Squeeze With the Catheter at the HPZ at 12 and 24 Weeks|Based on data collected from the manometry form, the outcome variable will be computed as the difference in maximum anal pressures during squeeze with the catheter at the high pressure zone (HPZ) at 12 and 24 weeks and maximum anal pressures during squeeze with the catheter at the HPZ at baseline.|12 and 24 weeks|An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.|||max. anal canal pressure squeeze (mmHg)||95% Confidence Interval|Mean
2614643|NCT02008565|Secondary|Change From Baseline Volume of Air (mL) at Urge to Defecate at 12 and 24 Weeks|Based on data collected from the manometry form, the outcome variable is computed as the difference in maximum tolerable rectal volume of air (mL) at 12 and 24 weeks and maximum tolerable rectal volume of air (mL) at baseline.|12 and 24 weeks|An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.|||volume of air (mL)||95% Confidence Interval|Mean
2614644|NCT02008565|Secondary|Change From Baseline Volume of Air (mL) at First Sensation for Perception of Rectal Distention at 12 and 24 Weeks|Based on data collected from the manometry form, the outcome variable is computed as the difference in volume of air (mL) at first sensation for perception of rectal distention at 12 and 24 weeks and volume of air (mL) at first sensation for perception of rectal distention at baseline.|12 and 24 weeks|An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.|||volume of air (mL)||95% Confidence Interval|Mean
2614645|NCT02008565|Secondary|Change From Baseline Resting Anal Canal Pressures (mm of Hg) at 2 cm, 1 cm, and 0 cm Insertion at 12 and 24 Weeks|Based on data collected from the manometry form, the outcome variable is computed as the difference in resting anal canal pressures (mm Hg) at 2 cm, 1 cm, and 0 cm insertion at 12 and 24 weeks and resting anal canal pressures (mm Hg) at 2 cm, 1 cm, and 0 cm insertion at baseline|12 and 24 weeks|An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.|||resting anal canal pressure (mm Hg)||95% Confidence Interval|Mean
2614646|NCT02008565|Secondary|Participants With Improvement in Patient Global Impression of Improvement (PGI-I) Score|The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better), or 3 (a little better).|12 and 24 Weeks|An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.|||Participants|||Count of Participants
2614647|NCT02008565|Secondary|Change in Fecal Incontinence Severity Index (FISI) Score|"The Modified Manchester Health Questionnaire (MMHQ) includes the 4-item Fecal Incontinence Severity Index (FISI), which measures the severity of liquid, solid, mucus, or gas incontinence that occurs from 2 or more times per day, once per day, 2 or more times per week, once a week, to 1-3 times per month. Patient-weighted scores were used to determine severity and scores ranged from 0-61, with higher scores indicating worse fecal incontinence (FI) severity. An FISI score of 0 indicated continence."|12 and 24 weeks|An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.|||units on a scale||95% Confidence Interval|Mean
2614648|NCT02008565|Secondary|Change From Baseline Total Number of Leaks Per Day at 12 and 24 Weeks|Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in daily average FI episodes at 12 and 24 weeks and the daily average FI episodes at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at 3 complete days, not necessarily consecutive, for follow-up diaries).|12 and 24 weeks|An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.|||leaks per day||95% Confidence Interval|Mean
2614649|NCT02008565|Secondary|Change From Baseline Pad-change Leaks Per Week at 12 and 24 Weeks|Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per week resulting in a change in pad, clothes or underwear at 12 and 24 weeks and the number of fecal incontinence episodes resulting in a change in pad, clothes or underwear at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at least 3 complete days, not necessarily consecutive, for follow-up diaries).|12 and 24 weeks|An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.|||pad-change leaks per week||95% Confidence Interval|Mean
2614650|NCT02008565|Secondary|Change From Baseline Pad-change Leaks Per Day at 12 and 24 Weeks|Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in number of fecal incontinence episodes per day resulting in a change in pad, clothes or underwear at 12 and 24 weeks and the number of fecal incontinence episodes resulting in a change in pad, clothes or underwear at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at least 3 complete days, not necessarily consecutive, for follow-up diaries).|12 and 24 weeks|An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.|||pad-change leaks per day||95% Confidence Interval|Mean
2614651|NCT02008565|Secondary|Change From Baseline Accident-free Days at 12 and 24 Weeks|Based on data collected from participant-completed diaries at baseline and 12 and 24 weeks, the outcome variable is computed as the difference in number of accident-free days at 12 and 24 weeks and the number of accident-free days at baseline. Only valid diaries were included in the analyses (e.g. completion of all 7 days for baseline and at least 3 complete days, not necessarily consecutive, for follow-up diaries).|12 and 24 weeks|An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.|||accident-free days||95% Confidence Interval|Mean
2614723|NCT02007720|Secondary|Time to In-hospital Worsening Heart Failure Through Day 5|Results are given in terms of number of participants with at least one in-hospital worsening heart failure through day 5 (pre-defined timeframe). In-hospital worsening heart failure is defined by symptoms only, signs only, and both symptoms and signs.|Through Day 5|Full analysis set with measure|||Participants|||Count of Participants
2614652|NCT02008565|Secondary|Change in Colorectal-Anal Subscale of the Pelvic Floor Impact Questionnaire Short Form (CRAIQ) Score|The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on the CRAIQ is 0-3 with (0) Not at all, (1) Somewhat, (2) Moderately, and (3), Quite a bit. Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Change = (Week [12, 24] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.|12 and 24 weeks|An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.|||units on a scale||95% Confidence Interval|Mean
2614653|NCT02008565|Secondary|Change in Quality of Life on Colorectal-Anal Distress Inventory (CRADI)|The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1) Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2) Colorectal Anal Distress Inventory (range: 0-100), and 3) Urinary Distress Inventory (range: 0-100). The range of responses on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Change = (Week [12, 24] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.|12 and 24 weeks|An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.|||units on a scale||95% Confidence Interval|Mean
2614654|NCT02008565|Primary|Change From Baseline St. Mark's (Vaizey) Score|"The primary outcome measure for all study arms is the change from baseline in St. Mark's (Vaizey) Score 24 weeks after treatment initiation to compare the marginal outcomes of anal exercise with biofeedback to usual care and loperamide to placebo.~The St. Mark's (Vaizey) score, published in 1999, is commonly used in clinical studies and reports and was based on the Jorge-Wexner score but added two further items for assessment: the use of constipating medication and the presence of fecal urgency. Minimum score is 0 = perfect continence; maximum score is 24 = totally incontinent."|12 and 24 weeks|An intent-to-treat (ITT) analysis was performed for primary analyses. ITT analysis included all eligible participants who were randomized. The primary analyses included randomized patients who provided outcome data at 12 or 24 weeks.|||units on a scale||95% Confidence Interval|Mean
2614655|NCT02008526|Secondary|HIV Primary Care|HIV-positive participants will be assessed according to their linkage/retention in HIV primary care and adherence to ART medication at 8-weeks, 3-, 6-, and 9-months post-randomization.|8-weeks post randomization, 3-/6-/9-months post randomization|||||||
2614656|NCT02008526|Primary|Cost Effectiveness|Cost-effectiveness data is collected quarterly throughout the course of the study using the UNAIDS template.|up to 36 months|||||||
2614657|NCT02008526|Primary|HIV Sexual Risk Behavior|Engagement in condomless anal intercourse was assessed at baseline and 9-month post-randomization follow-up.|9-months post randomization|Participants retained through nine months post randomization.|||# Episodes (Past 30 Days)||Standard Deviation|Mean
2614658|NCT02008526|Primary|Methamphetamine Use|Self-reported and/or biomarker-confirmed methamphetamine use assessed at baseline and 9-month follow-up assessment.|9-months post randomization|Number of participants retained through 9-month follow-up.|||Days Used in the Past 30 Days||Standard Deviation|Mean
2614659|NCT02008370|Secondary|Pain Scores|Subject reported surgical pain (using an 11-point numeric rating scale ).|First 5 post-op days|Lost to follow up||||||
2614660|NCT02008370|Secondary|Patient Satisfaction|Overall rating of subject satisfaction with postsurgical pain control|10 days +/- 5 days|Lost of follow-up.||||||
2614661|NCT02008370|Primary|Total Use of Analgesics|The other primary endpoint of this study is the effectiveness of analgesia from the thoracotomy and chest tube site infiltrations as measured by the overall postsurgical analgesic use, (converted to morphine equivalents).|5 days|None of the patients completed to date 5: Lost to follow-up||||||
2614662|NCT02008318|Secondary|Number of Participants With a Change in Bone Marrow Fibrosis Grading|Change from baseline in bone marrow fibrosis measured the number of participants with a change in bone marrow fibrosis grading (negative, mild, moderate, and severe).|Baseline, Cycle 6 (Cycle = 28 days)|Participants who received at least one dose of study drug and had both a baseline and postbaseline assessment excluding the exploratory participants.|||participants|||Number
2614663|NCT02008318|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the date of first dose to the date of death from any cause.|Baseline to date of death from any cause (Up to 2 years)|Participants who received at least one dose of study drug excluding the exploratory participants.|||days||Full Range|Median
2614664|NCT02008318|Secondary|Population Pharmacokinetics (PK): Mean Population Clearance of Galunisertib|Population mean (between-participant coefficient variation [CV%]) apparent clearance.|Day 1 pre-dose & between 0.5 to 2 hours post dose; Day 14 pre-dose, between 0.5 to 2 & between 3 to 5 hours post dose; Days 15 & 16 (if logistically possible) between 0.5 to 2 hours post dose|All participants who received at least one dose of study drug, regardless of dose, with evaluable PK data.|||Liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2614665|NCT02008318|Secondary|Percentage of Participants Who Are Hospitalized (Resource Utilization)|Percentage of any participant with a hospitalization admission and discharge date on the same day are counted as a half-day in the duration of hospitalization.|Baseline through end of study treatment (24 weeks)|Participants who received at least one dose of study drug.|||percentage of participants|||Number
2614666|NCT02008318|Secondary|Percentage of Participants With Cytogenetic Response|Percentage of Participants with Cytogenetic Response with either complete or partial response. Complete cytogenetic response is the disappearance of the chromosomal abnormality without appearance of new ones. Partial cytogenetic response is at least 50% reduction of the chromosomal abnormality.|Baseline through end of study treatment (24 weeks)|Participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2614668|NCT02008318|Secondary|Change From Baseline in Brief Fatigue Inventory (BFI)|The Brief Fatigue Inventory (BFI) is a brief participant-reported questionnaire that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. The severity of fatigue is assessed using an 11-point numeric scale, with 0 = no fatigue and 10 = fatigue as bad as you can imagine.|Baseline, Follow up (final visit up to 24 months)|Participants who received at least one dose of study drug.|||units on a scale||Standard Error|Least Squares Mean
2614669|NCT02008318|Primary|Percentage of Participants Who Are Transfusion-free or Have Hemoglobin (Hb) Increase ≥1.5 Grams/Deciliter Maintained for 8 Weeks During Phase 3|"Comparison of the percentage of participants with very low-, low-,and intermediate-risk MDS who were transfusion-free or had an increase ≥1.5 g/dL in hemoglobin (Hb) maintained for at least 8 weeks within the first 24 weeks of treatment with galunisertib plus best supportive care or placebo plus best supportive care and assessed by IPSS-R.~The Phase 3 portion of this study was not conducted because efficacy level required in phase 2 to move forward to phase 3 was not achieved."|Baseline through end of study treatment (24 weeks)|Participants who received at least one dose of study drug during Phase 3.||||||
2614670|NCT02008318|Primary|Percentage of Participants With Hematological Improvement (HI)|"Percentage of participants with hematological improvement (HI) based on International Working Group (IWG) 2006 criteria in participants with very low, low, and intermediate-risk myelodysplastic syndromes treated with Galunisertib plus best supportive care, as assessed by the International Prognostic Scoring System (IPSS-R).~To be classified as an HI responder, the HI response must have lasted at least 8 weeks (56 days)."|Baseline through end of study treatment (24 weeks)|Participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2614671|NCT02008227|Secondary|DOR as Determined by Investigator Using RECIST v1.1: SP ITT|DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.|From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)|The SP-ITT analysis set.|||Months||95% Confidence Interval|Median
2614672|NCT02008227|Secondary|Percentage of Participants With Objective Response as Determined Using RECIST v1.1: SP-ITT|Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.|Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)|SP-ITT analysis set.|||Percentage of Participants||95% Confidence Interval|Number
2614673|NCT02008227|Secondary|PFS as Determined by Investigator Using RECIST v1.1: SP-ITT|PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.|Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)|SP-ITT analysis set.|||Months||95% Confidence Interval|Median
2614674|NCT02008227|Primary|OS: TC3 or IC3 Subgroup of SP|OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.|Baseline until death due to any cause (up to approximately 2.87 years)|TC3 or IC3 Subgroup of SP.|||Months||95% Confidence Interval|Median
2614675|NCT02008227|Primary|OS: TC2/3 or IC2/3 Subgroup of SP|OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.|Baseline until death due to any cause (up to approximately 2.87 years)|TC2/3 or IC2/3 Subgroup of SP.|||Months||95% Confidence Interval|Median
2614676|NCT02008227|Primary|OS: TC1/2/3 Or IC1/2/3 Subgroup of SP|OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.|Baseline until death from any cause (approximately 2.87 years)|TC1/2/3 Or IC1/2/3 Subgroup of SP.|||Months||95% Confidence Interval|Median
2614677|NCT02008227|Primary|OS: SP-ITT|OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.|Baseline until death due to any cause (up to approximately 2.87 years)|Secondary population (SP) ITT analysis set included all 1225 randomized participants regardless of whether they received any study drug.|||Months||95% Confidence Interval|Median
2614678|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Sore Mouth|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for sore mouth.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
2614679|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in other parts.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
2614680|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for peripheral neuropathy.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
2614681|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Pain in Chest|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in chest.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
2614682|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in arm or shoulder.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
2614683|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Hemoptysis|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for hemoptysis.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
2614684|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Dyspnea|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dyspnea.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
2614685|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Dysphagia|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dysphagia.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
2614686|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Coughing|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for coughing.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
2614687|NCT02008227|Secondary|EORTC QLQ-LC13 Questionnaire Score: Alopecia|QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for alopecia.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
2614688|NCT02008227|Secondary|EORTC QLQ-C30 Questionnaire Score: Symptom Subscale|EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
2614705|NCT02008227|Primary|Overall Survival (OS): PP-ITT|OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.|Baseline until death due to any cause (up to approximately 2.25 years)|The PP-ITT analysis set.|||Months||95% Confidence Interval|Median
2614720|NCT02007720|Secondary|Number of Patients Reported With Total Adverse Events, Serious Adverse Events and Death.|To evaluate the safety and tolerability of intravenous serelaxin in AHF patients, number of patients with total adverse events, serious adverse events and death will be analyzed.|For the safety evaluation, all adverse events will be collected from signing of the informed consent form through Day 5 for non-serious AEs and through Day 14 for serious AEs.||||Participants|||Count of Participants
2614689|NCT02008227|Secondary|EORTC QLQ-C30 Questionnaire Score: GHS Scale|EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
2614690|NCT02008227|Secondary|EORTC QLQ-C30 Questionnaire Score: Functional Subscales|EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
2614691|NCT02008227|Secondary|EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items|EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)|The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||Units on a scale||Standard Deviation|Mean
2614692|NCT02008227|Secondary|Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)|TTD in patient-reported lung cancer symptoms (pain in chest or in arm/shoulder, dyspnea, or cough) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the symptoms. A >/=10-point change in the score perceived by participants was considered as clinically significant. The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity.|Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)|The PP-ITT analysis set.|||Months||95% Confidence Interval|Median
2614693|NCT02008227|Secondary|Minimum Observed Serum Atezolizumab Concentration (Cmin)||Predose (Hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24, 32, EOT (approximately 2.25 years); 120 days after EOT (approximately 2.25 years) (1 Cycle=21 days)|PK evaluable participants. Here, 'n' signifies those participants evaluated for this measure at specific time point. All 606 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.|||mcg/mL||Standard Deviation|Mean
2614694|NCT02008227|Secondary|Maximum Observed Serum Atezolizumab Concentration (Cmax)||Predose (Hr 0), 30 minutes (min) post-infusion (infusion duration: 60 min) on Cycle 1 Day 1 (1 Cycle=21 days)|Pharmacokinetic (PK) evaluable population included participants who received atezolizumab treatment and had at least one measurable PK concentration.|||Microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2614695|NCT02008227|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab||Baseline up to approximately 2.25 years (assessed at predose [Hour {Hr} 0] on Day 1 of Cycles 1, 2, 3, 4, 8, 16, then every 8 cycles up to end of treatment (EOT) [approximately 2.25 years]; 120 days after EOT [approximately 2.25 years] [1 Cycle=21 days])|ATA evaluable population included all participants who received atezolizumab treatment and had at least one post treatment ATA result.|||Percentage of Participants|||Number
2614721|NCT02007720|Secondary|Change From Baseline in Cardio-renal Biomarkers||Day 2 and Day 5|The data was not collected, and analysis not performed, as the trial was terminated prematurely||||||
2620543|NCT01954160|Secondary|Plasma Renin Activity||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2614696|NCT02008227|Secondary|DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP|DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.|From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)|The TC1/2/3 or IC1/2/3 subgroup of PP|||Months||95% Confidence Interval|Median
2614697|NCT02008227|Secondary|Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT|DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.|From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)|The PP-ITT analysis set.|||Months||95% Confidence Interval|Median
2614698|NCT02008227|Secondary|Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP|Objective response is defined as a CR or PR as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.|Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)|The TC1/2/3 or IC1/2/3 subgroup of PP|||Percentage of Participants||95% Confidence Interval|Number
2614699|NCT02008227|Secondary|Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT|Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.|Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)|The PP-ITT analysis set.|||Percentage of Participants||95% Confidence Interval|Number
2614700|NCT02008227|Secondary|PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP|PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.|Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)|The TC1/2/3 or IC1/2/3 subgroup of PP|||Months||95% Confidence Interval|Median
2614701|NCT02008227|Secondary|Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT|PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.|Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)|The PP-ITT analysis set.|||Months||95% Confidence Interval|Median
2614702|NCT02008227|Secondary|Percentage of Participants With PD as Determined by Investigator Using RECIST v1.1 or Death: TC1/2/3 or IC1/2/3 Subgroup of PP|PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.|Baseline up to PD or Death (up to approximately 2.25 years)|TC1/2/3 or IC1/2/3 subgroup of PP|||Percentage of Participants|||Number
2614703|NCT02008227|Secondary|Percentage of Participants With Disease Progression (PD) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death: PP-ITT|PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeters (mm), or presence of new lesions.|Baseline up to PD or Death (up to approximately 2.25 years)|The PP-ITT analysis set|||Percentage of Participants|||Number
2614704|NCT02008227|Primary|OS: TC1/2/3 or IC1/2/3 Subgroup of PP|OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.|Baseline until death due to any cause (up to approximately 2.25 years)|TC1/2/3 or IC1/2/3 subgroup of PP|||Months||95% Confidence Interval|Median
2614706|NCT02008227|Primary|Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP|Percentage of participants who died among TC1/2/3 or IC1/2/3 subgroup of PP-ITT were reported. TC1 = presence of discernible programmed death-ligand 1 (PD-L1) staining of any intensity in >/=1% and <5% TCs; TC2: presence of discernible PD-L1 staining of any intensity in >/=5% and <50% TCs; TC3 = presence of discernible PD-L1 staining of any intensity in >/=50% TCs; IC1 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=1% and <5% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC2 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=5% and <10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC3 = presence of discernible PD-L1 staining of any intensity in ICs covering >/=10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma.|Baseline until death due to any cause (up to approximately 2.25 years)|TC1/2/3 or IC1/2/3 subgroup within PP included ITT participants with the corresponding programmed death-ligand 1 (PD-L1) expression status.|||Percentage of Participants|||Number
2614707|NCT02008227|Primary|Percentage of Participants Who Died: PP-ITT||Baseline until death due to any cause (up to approximately 2.25 years)|PP-ITT analysis set included the first 850 randomized ITT participants regardless of whether they received any study drug.|||Percentage of Participants|||Number
2614708|NCT02008149|Primary|Bone Mineral Density|Bone mineral density at the distal femur at 0, 16, 29 and 43 weeks measured using peripheral quantitative computed tomography scanning.|0, 16, 29 and 43 weeks|The only participant in the Stanford-of-Care Control group self-withdrew after 12 weeks of participation, after having a baseline measurement and one other bone density measurement. The participant in the Experienced FES-Rower group was only measured at baseline.|||g/cm^3||Full Range|Mean
2614709|NCT02007954|Other Pre-specified|Exploratory Endpoint - Tmax of Doxorubicin and Doxorubicinol Post DEBDOX-M1 TACE|Time taken to reach maximum concentration (Tmax) of doxorubicin and its metabolite doxorubicinol post DEBDOX-M1 in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 20min, 40min, 1hr, 2hr, and 24hr post administration of 50-100mg doxorubicin..|24 hours||||minutes||Standard Deviation|Mean
2614710|NCT02007954|Other Pre-specified|Exploratory Endpoint - Total Drug Exposure Over Time (AUC) of Doxorubicin and Doxorubicinol Post TACE|Total drug exposure over time (AUC) of doxorubicin and its metabolite doxorubicinol post DEBDOX in the first 10 patients enrolled on protocol. Time points assessed in protocol were pre-dose, and then 5min, 20min, 40min, 1hr, 2hr, and 24hr post administration of 50-100mg doxorubicin..|24 hours||||ng*h/mL||Standard Deviation|Mean
2614711|NCT02007954|Other Pre-specified|Exploratory Endpoint - Pharmacokinetic (PK) Profile of Doxorubicin and Doxorubicinol Post DEBDOX-M1 TACE|"PK analysis of doxorubicin and its metabolite doxorubicinol post DEBDOX-M1 in the first 10 patients enrolled on protocol including peak plasma concentration (Cmax).~Time points assessed in protocol were pre-dose, and then 5min, 20min, 40min, 1hr, 2hr, and 24hr post administration of 50-100mg doxorubicin."|24 hours||||ng/mL||Standard Deviation|Mean
2614712|NCT02007954|Secondary|AFP Tumor Marker Pre- and Post-treatment|The change in alpha-fetoprotein tumor marker levels pre- and post-treatment with one DEBDOX-M1 TACE procedure.|1 month|23 out of 24 patients analyzed due to one patient not completing AFP post-TACE.|||ng/mL||Full Range|Mean
2614713|NCT02007954|Secondary|Efficacy - Number of Patients Downstaged or Bridged to Surgical Interventions|The number of patients who underwent a liver transplantation following treatment on this protocol.|6 months||||Participants|||Count of Participants
2614714|NCT02007954|Secondary|Efficacy - Tumor Response by mRECIST|"Efficacy as assessed by radiographic tumor response using modified RECIST (mRECIST) criteria at baseline and at 1-month imaging following TACE treatments.~Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions Partial Response (PR): At least 30% decrease in the sum of diameters of viable target lesions, taking as reference the baseline sum of the diameters of target lesions Progressive Disease (PD): At least 20% increase in the sum of diameters of viable target lesions, taking as reference the smallest sum of diameters of viable target lesions since treatment started Stable Disease (SD): Any cases that do not qualify for either PR or PD."|1 month||||Participants|||Count of Participants
2614715|NCT02007954|Secondary|Efficacy - Tumor Response by qEASL|"Efficacy as assessed by radiographic tumor response using qEASL at baseline and at 1-month imaging following TACE treatments.~Complete Response (CR): Disappearance of any intratumoral arterial enhancement in all target lesions.~Partial Response (PR): At least a 65% decrease in the sum of enhancing tissue volume of the lesions.~Stable Disease (SD): Any cases that do not qualify for complete response, partial response, or progressive disease.~Progressive Disease (PD): an increase of at least 73% in the sum of enhancing tissue volume of the lesions."|1 month||||Participants|||Count of Participants
2614716|NCT02007954|Secondary|Efficacy - Tumor Response by EASL|"Efficacy as assessed by radiographic tumor response using EASL amendment at baseline and at 1 month imaging following TACE treatments.~Complete Response (CR): Achieving 100% tumor necrosis of lesions targeted by DEBDOX-M1. Baseline degree of tumor enhancement used as a reference.~Partial Response (PR): Demonstrating greater than 50% tumor necrosis in lesions targeted by DEBDOX-M1.~Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression of lesions targeted by DEBDOX-M1.~Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in lesions previously targeted by DEBDOX-M1."|1 month||||Participants|||Count of Participants
2614717|NCT02007954|Primary|Collection of Adverse Events Related to Study Device as a Measure of Safety|For safety, all toxicities assessed as being at least possibly related will be analyzed by descriptive statistics to show type, grade (NCI Common Toxicity Criteria v.4 toxicity criteria), frequency and time from DEBDOX-M1TACE.|1 month|30-day toxicity report of device-related adverse events for all 24 patients with classification and grading based on CTCAE v4.0.|||Adverse Events|||Number
2614718|NCT02007954|Primary|Success of DEBDOX-M1 Procedure as a Measure of Feasibility|Feasibility is defined as achieving an acceptable level of technical success in the use of DEBDOX-M1 beads treating hepatic lesions in patients with hepatocellular carcinoma.|6 months|The 24 patients received a total of 50 DEBDOX-M1 TACE procedures.|||percentage of successful treatments|DEBDOX-M1 treatments||Number
2614722|NCT02007720|Secondary|Use of Loop Diuretic and Vasoactive Agents|Number of patients reported with use of loop diuretic and vasoactive agents from randomization through Day 5|Through Day 5|full analysis set with measure|||participants|||Number
2614724|NCT02007720|Secondary|Time to CV Death or Re-hospitalization Due to Heart Failure/ Renal Failure|Results are given in terms of number of participants with CV death or at least one re-hospitalization due to Heart Failure through day 180 (pre-defined timeframe).|Through Day 180|Full analysis set (FAS) - All patients in the randomized population who were not misrandomized patients*. Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they had been assigned to at the randomization|||Participants|||Count of Participants
2614725|NCT02007720|Secondary|Time to Re-hospitalization Due to Heart Failure and Renal Impairment|Time to event is computed as the number of days from randomization to re-hospitalization due to Heart Failure and renal impairment|Through Day 180||||days|||Number
2614726|NCT02007720|Secondary|Renal Dysfunction and Prevention of Worsening of Renal Function|number of participants with renal dysfunction or in-hospital worsening of renal function through Day 5|Through Day 5|Full analysis set with measure|||participants|||Number
2614727|NCT02007720|Secondary|Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization|Length of stay will be defined as the hospitalization discharge date and the time minus the baseline date and time plus 1 day|Up to day 30|full analysis set with measure|||days||Standard Deviation|Mean
2614728|NCT02007720|Secondary|Dyspnea by VAS-AUC Changes|Change from baseline in Dyspena by VAS-AUC through Day 5, expressed in mm-hours|Through Day 5|full analysis set with measure|||mm-hours||Standard Deviation|Mean
2614729|NCT02007720|Secondary|Time to Moderate or Marked Improvements in Dyspnea by Likert Scale, Expressed in Days|Time to event is computed as the number of days from randomization to moderate or marked improvements in dyspnea by Likert scale|Through Day 5|Full analysis set (FAS)with measure|||days||Standard Deviation|Mean
2614730|NCT02007720|Secondary|Time to All-cause Death|Results are given in terms of number of participants with all cause death event through day 180 (pre-defined timeframe).|Through Day 180|Full analysis set (FAS) - All patients in the randomized population who were not misrandomized patients*. Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they had been assigned to at the randomization|||Participants|||Count of Participants
2614731|NCT02007720|Secondary|Time to CV Death|analysis of time to CEC CV death through day 180 : results are given in terms of number of participants with CV death event through day 180 (pre-defined timeframe).|Through Day 180|Full analysis set (FAS) - All patients in the randomized population who were not misrandomized patients*. Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they had been assigned to at the randomization|||Participants|||Count of Participants
2614732|NCT02007720|Secondary|Time to WHF|Results are given in terms of number of participants with at least one worsening heart failure (WHF) event through day 5 (pre-defined timeframe).|Through Day 5|Full analysis set (FAS) - All patients in the randomized population who were not misrandomized patients*. Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they had been assigned to at the randomization|||Participants|||Count of Participants
2614733|NCT02007720|Primary|Percentage of Patients With a Clinical Composite Endpoint of Treatment Success, Treatment Failure, or no Change.|The trichotomous clinical composite endpoint of treatment success, treatment failure, or no change. Treatment success defined as improvement of dyspnea by Likert scale and at least 2 points improvement by at least 2 physician assessed signs and symptoms (orthopnea, rales edema, and jugular venous pulse) at Day 2; treatment failure defined as worsening heart failure, death, or re-hospitalization due to heart failure or renal failure through Day 5; no change defined as neither the criteria for treatment success nor the criteria for treatment failure was met through Day 5.|through day 5|Full analysis set (FAS) - All patients in the randomized population who were not misrandomized patients. Following the intent-to-treat (ITT) principle, patients were analyzed according to the treatment they had been assigned to at the randomization|||Participants|||Count of Participants
2614734|NCT02007577|Secondary|Quantification of Insulin Clearance With the Graded Glucose Infusion Test (GGIT)|compare changes in insulin clearance as assessed by the GGIT before and after treatment with salsalate to placebo|one month on treatment||||pmol/min x 4h||95% Confidence Interval|Median
2614735|NCT02007577|Primary|Quantification of Insulin Action With the Insulin Suppression Test (IST)|Compare changes in insulin sensitivity as assesses by the IST before and after treatment between salsalate and placebo group|after treatment for one month||||mmol/L||95% Confidence Interval|Median
2614736|NCT02007512|Other Pre-specified|Progression Free Survival (PFS): Diagnostic Positive (DX+) Population By Electronic Data Capture (EDC)|PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD according to RECIST 1.1, was defined as >= 20% increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first.|From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years)|"Dx+ population: Subset of ITT population, defined prior to the first unblinded analysis as meeting the threshold for diagnostic score based on ribonucleic acid (RNA) sequencing data from tumor tissue. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||months||95% Confidence Interval|Median
2614747|NCT02007512|Secondary|Concentration Versus Time Summary of Enzalutamide|Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero.|Predose on Day 29, 57 and 113|Pharmacokinetic (PK) population for enzalutamide included all participants in safety population who received any amount of enzalutamide and had at least 1 reportable concentration value for enzalutamide or its active metabolite (N-desmethyl enzalutamide).|||microgram per milliliter||Standard Deviation|Mean
2614766|NCT02007434|Primary|Change From Baseline in Pain Visual Analog Scale Scores|Participants were provided with a scale 100 mm in length and were asked to mark the place on the line that best represents his or her pain associated with the area treated with study drug. The scale ranged from 0 (no pain) to 100 (most severe pain possible).|Baseline and Day 84|Safety analysis set with available data at both time points|||units on a scale||Full Range|Median
2614737|NCT02007512|Other Pre-specified|Progression Free Survival (PFS): By Electronic Data Capture (EDC)|PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD according to RECIST 1.1 was defined >=20 % increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first. Cht 1: Enz + Exe = Cohort 1: Enzalutamide 160 mg + Exemestane 50 mg; Cht 2: Enz + Exe= Cohort 2: Enzalutamide 160 mg + Exemestane 50 mg|From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years)|Analysis was performed on all randomized participants. Randomization to cohort was based on participant’s exposure to advance setting hormonal therapy. Initial randomization was done by IWRS. Later, upon detailed data entry in EDC, it was determined 1 participant was incorrectly assigned to Cht1:Enz+Exe by IWRS,hence counted in Cht2:Enz+Exe by EDC.|||months||95% Confidence Interval|Median
2614738|NCT02007512|Other Pre-specified|Number of Participants With Clinically Significant Laboratory Abnormalities|Laboratory tests included hematology (hematocrit, hemoglobin, platelet count, red blood cell count, total neutrophils [absolute] and white blood cell count with differential) and serum chemistry (albumin, alkaline phosphatase, alanine aminotransferase [ALT], aspartate transaminase [AST], blood urea nitrogen and creatinine, calcium, sodium, potassium, chloride, glucose (non-fasting), lactate dehydrogenase, magnesium, phosphorus/phosphate, total bilirubin, total bicarbonate, total protein and uric acid). Clinically significant abnormality evaluation was based on clinical investigator's judgment.|Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years)|Safety population included all the participants who received study drug either in double blind or in open label treatment period.|||participants|||Number
2614739|NCT02007512|Other Pre-specified|Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for clinically significant vital sign abnormalities: Systolic blood pressure (SBP): absolute SBP <90 millimeters of mercury (mmHg) and decrease from baseline (DFB) >30 mmHg, absolute SBP>180 mmHg and increase from baseline (IFB) >40 mmHg, final visit or 2 consecutive visits SBP >=20 mmHg change from baseline (CFB), most extreme post-baseline SBP >=140 mmHg, most extreme post-baseline SBP >=180 mmHg, most extreme SBP >=140 mmHg and >=20 mmHg CFB, most extreme SBP >=180 mmHg and >=20 mmHg CFB; diastolic blood pressure (DBP): absolute DBP > 105 mmHg and IFB >30 mmHg, absolute DBP <50 mmHg and DFB >20 mmHg, final visit or 2 consecutive visits DBP >=15 mmHg CFB, most extreme post-baseline DBP >=90 mmHg, most extreme post-baseline DBP >=105 mmHg, most extreme DBP >=90 mmHg and >=15 mmHg CFB, most extreme DBP >=105 mmHg and >=15 mmHg CFB; heart rate <50 beats per minute (BPM) and DFB >20 BPM or heart rate >120 BPM and IFB >30 BPM.|Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years)|Safety population included all the participants who received study drug either in double blind or in open label treatment period.|||participants|||Number
2614740|NCT02007512|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events of Grade 3 or Higher Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Only the participants with treatment-emergent AEs of grade 3 (severe) or higher grade were reported in this outcome measure.|Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years)|Safety population included all the participants who received study drug either in double blind or in open label treatment period.|||participants|||Number
2614741|NCT02007512|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs.|Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to 3 years)|Safety population included all the participants who received study drug either in double blind or in open label treatment period.|||participants|||Number
2614742|NCT02007512|Other Pre-specified|Number of Participants With Positive Androgen Receptor (AR) Expression by Immunohistochemistry (IHC)||Day 1, 29, 57, 113 and 169|Protocol of this study was amended and data for this outcome measure was not analyzed as per planned analysis.||||||
2614743|NCT02007512|Other Pre-specified|European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer Module (QLQ-BR23)||Month 24|||||||
2614744|NCT02007512|Other Pre-specified|European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Core Questionnaire (QLQ-C30)||Month 24|||||||
2614745|NCT02007512|Secondary|Concentration Versus Time Summary of N-desmethyl Enzalutamide|N-desmethyl enzalutamide was the active metabolite of enzalutamide. Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero.|Predose on Day 29, 57 and 113|PK population for N-desmethyl enzalutamide included all the participants in safety population who received any amount of enzalutamide and had at least 1 reportable concentration value for N-desmethyl enzalutamide.|||microgram per milliliter||Standard Deviation|Mean
2614746|NCT02007512|Secondary|Concentration Versus Time Summary of Exemestane|Concentration versus time summary was calculated by setting concentration values below limit of quantitation to zero.|Predose, 1 and 6 hour postdose on Day 29, 57, 113 and 169|PK population for exemestane was defined as all participants in the safety population who received any amount of exemestane and had at least 1 reportable plasma concentration value for exemestane.|||Picogram per milliliter||Standard Deviation|Mean
2620544|NCT01954160|Secondary|Resting Urine Norepinephrine||13 Weeks following Renal Denervation|||||||
2614748|NCT02007512|Secondary|Progression Free Survival (PFS) at 6 Months|PFS at 6 months was defined as the percentage of participants with no event of disease progression at Month 6 landmark, estimated by Kaplan-Meier methods. PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. The analysis of PFS was based on investigator assessment of disease progression.|Month 6|ITT population included all the participants randomly assigned to double-blind study treatment.|||percentage of participants||95% Confidence Interval|Number
2614749|NCT02007512|Secondary|Time to Progression|Time to progression was defined as the time from the date of randomization to PD defined by the investigator using RECIST 1.1. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. Participants who did not experience disease progression, time to progression was right censored at the date of the last tumor assessment prior to data cutoff or date of new antitumor treatment, whichever occurred first.|From randomization until PD or last tumor assessment without PD before new antitumor treatment initiation, whichever occurred first (up to 3 years)|ITT population included all the participants randomly assigned to double-blind study treatment.|||months||95% Confidence Interval|Median
2614750|NCT02007512|Secondary|Time to Response|Time to response: Time from randomization to first documentation of CR or PR. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (<10 mm short axis). PR: >=30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. Participants who were not known to have had a CR or PR were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first.|From randomization until first documentation of CR or PR, or last tumor assessment without PD or death prior to new antitumor treatment initiation, whichever occurred first (up to 3 years)|ITT population included all the participants randomly assigned to double-blind study treatment. Here 'Number of participants analyzed' signifies participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2614751|NCT02007512|Secondary|Duration of Objective Response|Duration of objective response: Time from first documentation of CR or PR, to the first documentation of PD or death due to any cause, whichever occurred first as determined by investigator using RECIST 1.1. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (<10 mm short axis). PR: >=30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions. Participants with no PD or death (after initial CR or PR) at the analysis date were censored at last tumor assessment date prior to date of new antitumor treatment or data cutoff.|From first documentation of CR or PR until PD, or last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years)|ITT population included all the participants randomly assigned to double-blind study treatment. Here 'Number of participants analyzed' signifies participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2614752|NCT02007512|Secondary|Best Objective Response Rate|Best objective response rate: Percentage of participants with measurable disease and with a best response of CR or PR according to RECIST 1.1. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (<10 mm short axis). PR: Atleast 30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. Response evaluation was based on investigators' judgment.|From randomization until CR or PR, whichever occurred first (up to 3 years)|ITT population included all the participants randomly assigned to double-blind study treatment. Here 'Number of participants analyzed' signifies participants with measurable response.|||percentage of participants||95% Confidence Interval|Number
2614753|NCT02007512|Secondary|Clinical Benefit Rate-24 (CBR-24)|CBR-24: Percentage of participants with a best response of complete response (CR), partial response (PR), or stable disease (SD) sustained for atleast 24 weeks, as determined by investigator using RECIST 1.1. CR: Disappearance of all (target and non-target) lesions and normalization of tumor marker level for non-target lesions. All lymph nodes (target and non-target) must be non-pathological in size (less than [<] 10 millimeter [mm] short axis). PR: >=30% decrease in sum of diameters of target lesions, using baseline sum diameters as reference. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during study as reference. PD: >=20% increase (an absolute increase of >=5 mm) in sum of diameters of target lesions, using the smallest sum during the study as a reference (including baseline sum), or unequivocal progression of existing non-target lesions, or appearance of atleast 1 new target or non-target lesions.|From randomization up to 3 years|ITT population included all the participants randomly assigned to double-blind study treatment.|||percentage of participants||95% Confidence Interval|Number
2614765|NCT02007434|Primary|Change From Baseline in Pain Assessment Using McGill Pain Questionnaire|Participants rated 15 pain characteristics by using a number to signify how much of that specific type of pain they were experiencing using the Short-Form McGill Pain Questionnaire. The pain characteristic options included Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, and Punishing- cruel. Participants assessed the intensity of each characteristic using the following score system: none (0), mild (1), moderate (2), and severe (3). In addition, present pain was assessed on a scale from 0 (no pain) to 5 (excruciating).|Baseline (predose) and Day 84|Safety analysis set with available data at both time points|||units on a scale||Standard Deviation|Mean
2614754|NCT02007512|Primary|Progression Free Survival (PFS): Diagnostic Positive (DX+) Population By Interactive Web Recognition System (IWRS)|PFS was defined as the time in months from randomization to the first documentation of PD or death on study due to any cause, whichever occurred first. PD according to RECIST 1.1, was defined as >= 20% increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first.|From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years)|"Dx+ population: Subset of ITT population, defined prior to the first unblinded analysis as meeting the threshold for diagnostic score based on ribonucleic acid (RNA) sequencing data from tumor tissue. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||months||95% Confidence Interval|Median
2614755|NCT02007512|Primary|Progression Free Survival (PFS): Intent-to-Treat (ITT) Population By Interactive Web Recognition System (IWRS)|PFS was defined as the time in months from randomization to the first documentation of progression of disease (PD) or death on study due to any cause, whichever occurred first. PD according to response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) was defined as greater than or equal to (>=) 20 percent (%) increase in the sum of diameters of the target lesions taking as a reference the smallest sum recorded since the start of treatment or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. The analysis of PFS was based on investigator assessment of disease progression. Participants who were not known to have had a PFS event at the analysis date were censored at last tumor assessment date prior to data cutoff or date of new treatment initiation, whichever occurred first.|From randomization until PD, last tumor assessment without PD before new antitumor treatment initiation or death due to any cause, whichever occurred first (up to 3 years)|ITT population included all the participants randomly assigned to double-blind study treatment.|||months||95% Confidence Interval|Median
2614756|NCT02007434|Secondary|Patient Experience Questions|"Participants were asked to complete 3 patient experience questions, each answered as Yes or No:~Given your experience in this study:~Would you recommend this procedure to a friend?~Would you agree to receive additional treatments?~Has the treatment you received in this study affected your normal activities?~The percentage of participants answering Yes on each question is reported."|Day 84|Safety analysis set with available data at each time point|||percentage of participants|||Number
2614757|NCT02007434|Secondary|Change From Baseline in Submental Fat Thickness|Submental thickness was measured using caliper devices.|Baseline and Day 84|Safety analysis set with available data at both time points|||mm||Standard Deviation|Mean
2614758|NCT02007434|Secondary|Change From Baseline in Submental Skin Laxity Grades (SMSLG)|Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale: 1 = no laxity; 2 = mild laxity; 3 = moderate laxity; 4 = severe laxity. A negative change from Baseline indicates improvement.|Baseline and Day 84|Safety analysis set with available data at both time points|||units on a scale||Standard Deviation|Mean
2614759|NCT02007434|Secondary|Change From Baseline in Subject Self Rating Scale (SSRS)|The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied. A positive change from Baseline indicates improvement.|Baseline and Day 84|Safety analysis set with available data at both time points|||units on a scale||Standard Deviation|Mean
2614760|NCT02007434|Secondary|Change From Baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. A negative change from Baseline indicates improvement."|Baseline and Day 84|Safety analysis set with available data at both time points|||units on a scale||Standard Deviation|Mean
2614761|NCT02007434|Secondary|Change From Baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)|The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement.|Baseline and Day 84|Safety analysis set with available data at each time point.|||units on a scale||Standard Deviation|Mean
2614762|NCT02007434|Primary|Induration Grading Scale Scores|"The following grading system was used for the assessment of induration:~Induration absent to minimal (0)~Induration associated with at least approximately 30% of the treatment area (1)~Induration associated with greater than approximately 30% to at least 60% of the treatment area (2)~Induration covering the entire treatment area but contained within the treatment area (3)~Induration of the neck and face beyond the treatment area (4)"|Day 84|Safety analysis set with available data|||units on a scale||Standard Deviation|Mean
2614763|NCT02007434|Primary|Bruising Grading Scale Scores|"The following grading system was used for the assessment of bruising:~Bruising absent (0)~Bruising associated with 1 to 3 needle insertion points (1)~Bruising spreading beyond 4 or more individual needle insertion points but contained within the treatment area (2)~Bruising covering the entire treatment area but contained within the treatment area (3)~Bruising of the neck and face beyond the treatment area (4)"|Day 84|Safety analysis set with available data|||units on a scale||Standard Deviation|Mean
2614764|NCT02007434|Primary|Swelling Grading Scale Scores|"The following grading system was used for the assessment of swelling:~Swelling/edema absent (0)~Minimal swelling/edema contained within treatment area (1)~Modest swelling/edema contained within treatment area (2)~Substantial swelling/edema contained within treatment area (3)~Swelling/edema of the neck and face beyond the treatment area (4)"|Day 84|Safety analysis set with available data|||units on a scale||Standard Deviation|Mean
2614839|NCT02006758|Secondary|Mean Change in Ambulatory Systolic Blood Pressure at 1 Month||Baseline and 1 month|23 out of 67 participants analyzed for mean change in ambulatory Systolic Blood Pressure at 1 month|||mmHg||Standard Deviation|Mean
2614767|NCT02007369|Secondary|Point Prevalence of Self Reported Abstinence for the Previous 7 Days at 6 Months|The outcome was assessed by any self-reported cigarette consumption in the past 7 days at the time of the follow-up. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported abstinence for the previous 7 days at 6 months.|6 months||||participants|||Number
2614768|NCT02007369|Primary|Self Reported Relapse Rate at 6 Months|Relapse is defined as smoking 5 cigarettes in 3 consecutive days since the most recent quitting. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported relapse rate at 6 months.|6-months||||participants|||Number
2614769|NCT02007369|Secondary|Point Prevalence of Self Reported Abstinence for the Previous 7 Days at 2 Months|The outcome was assessed by any self-reported cigarette consumption in the past 7 days at the time of the follow-up. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported abstinence for the previous 7 days at 2 months.|2 months||||participants|||Number
2614770|NCT02007369|Primary|Self Reported Relapse Rate at 2 Months|Relapse is defined as smoking 5 cigarettes in 3 consecutive days since the most recent quitting. A questionnaire asking smoking status, quitting experience and difficulty in quitting was designed to assess the self reported relapse rate at 2 months.|2 months after joining the groups for the social networking services.||||participants|||Number
2614771|NCT02007291|Secondary|Independence for Daily Activities Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease|Patients presented mild or moderate dementia according to the Clinical Dementia Rating (CDR). None of the individuals had been treated with Cholinesterase inhibitors (ChEI) or memantine before study entry. Donepezil, galantamine or rivastigmine were prescribed to the patients according to the clinicians' preferences. All participants were evaluated by one board certified geriatrician (LFJRM) at baseline and after 3 months of treatment, as part of an ongoing 12-month responder analysis study of ChEI in AD. The secondary domain examined was independence for daily activities and the evaluation tools used was the brazilian version of the Pfeffer Functional Activities Questionnaire (PFAQ). PFAQ scale range from 0 to 30 points and the greater value is associated with a greater dependence in daily activities.|three months||||units on a scale||Standard Deviation|Mean
2614772|NCT02007291|Primary|Cognitive Response After Three Months of Treatment With ChEI in Mild and Moderate Alzheimer's Disease|Patients presented mild or moderate dementia according to the Clinical Dementia Rating (CDR). None of the individuals had been treated with Cholinesterase inhibitors (ChEI) or memantine before study entry. Donepezil, galantamine or rivastigmine were prescribed to the patients according to the clinicians' preferences. All participants were evaluated by one board certified geriatrician (LFJRM) at baseline and after 3 months of treatment, as part of an ongoing 12-month responder analysis study of ChEI in Alzheimer's Disease. The main domain examined and the evaluation tools was cognition and Mini-Mental State Examination- MMSE, respectively. MMSE scores range from 0 to 30, while the greater value is associated with a better cognition state. An increase of 2 or more points in MMSE was considered as response.|three months||||units on a scale||Standard Deviation|Mean
2614773|NCT02007278|Secondary|Number of Patients With Any Adverse Events, Serious Adverse Events and Death||12 weeks|All the randomized patients.|||Patients|||Number
2614774|NCT02007278|Secondary|Mean Amplitude of Glycemic Excursions (MAGE) for Patients With Hypoglycemia Incidence After 12 Weeks of Treatment|MAGE , which determines the average blood glucose excursions either above or below a value of one standard deviation of the average value of glucose in a given day. MAGE is calculated from the data of continuous tissue glucose monitoring obtained during the measurement period. MAGE is calculated with the formula Σ λ / χ if λ> ν (where λ = changes in blood glucose from peak to nadir, χ = number of valid observations, ν = 1 standard deviation of the mean glucose during a period of 24 hours) from the data of continuous monitoring of the tissue glucose, obtained during the period of measurement. In this endpoint, mean MAGE value is reported for hypo glycemic patients.|12 weeks|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison and had at least one hypoglycemia event.|||mg/dL||Standard Deviation|Mean
2614775|NCT02007278|Secondary|Number of Patients With Incidence of Hypoglycemia|Hypoglycemia defined as Glycemia < 70 mg/dl|12 weeks|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison.|||Patients|||Number
2614776|NCT02007278|Secondary|Change in HbA1c at Week 12 of Treatment in Comparison to HbA1c at Baseline||baseline, 12 weeks of treatment|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have confirmed non-concordant data|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
2614777|NCT02007278|Secondary|Percentage of Patients Who Achieved a Decrease Equal to or Greater Than 0.3% in Value of HbA1c at Week 12||Screening visit , 12 weeks of treatment|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have confirmed non-concordant data|||percentage of patients|||Number
2614778|NCT02007278|Secondary|Glycemic Variability Measured by Total Standard Deviation (TSD)|"Total standard deviation (TSD) or standard deviation of all values of a given measurement period, which has the advantage of being able to include all measured values on a given time period (even several days) through a common and simple statistical concept.~TSD is calculated conventionally with the formula σ = √Σ (Xi - ῦ) 2 / N (where Xi represents each of the values, ῦ represents the population mean and N is the number of observations) from the data of continuous monitoring of tissue glucose obtained during the measurement."|Week 12|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison.|||mg/dL||Standard Deviation|Mean
2614801|NCT02007070|Secondary|PFS Per irRC in Strongly PD-L1 Positive Participants|PFS was defined as the time from the first day of study treatment to the first documented disease progression per irRC or death due to any cause, whichever occurred first. Using irRC, progressive disease was defined as at least a 25% increase in SPD relative to minimum recorded tumor burden. Confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented was required. Median PFS was analyzed using the Kaplan-Meier method and is presented in months for all strongly PD-L1 positive participants.|Up to 2 years|The ATS population for this outcome measure consisted of all strongly PD-L1 positive participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2614779|NCT02007278|Secondary|Glycemic Variability Measured by Continuous Overlapping Net Glycemic Action (CONGA)|"Continuous Overlapping Net Glycemic Action (CONGA) which assesses intra-day glycemic variability by calculating the difference between values at different intervals, adjusted according to requirements with the advantage of being highly reproducible.~CONGA is calculated in the conventional way with the formula √tқΣt = t1 (Dt -Ď2) / қ - 1, Ď = tқ Σ Dt t = t1 / қ, Dt = Gt-Gt-m (where қ = Observations with an observation n x 60 minutes, G = glucose measure) from the data of continuous monitoring of tissue glucose obtained during the measurement period."|Week 12|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison.|||mg/dL||Standard Deviation|Mean
2614780|NCT02007278|Primary|Glycemic Variability Measured by Mean Amplitude of Glucose Excursions (MAGE)|Mean Amplitude of Glycemic Excursions (MAGE) , which determines the average blood glucose excursions either above or below a value of one standard deviation of the average value of glucose in a given day. MAGE is calculated from the data of continuous tissue glucose monitoring obtained during the measurement period. MAGE is calculated with the formula Σ λ / χ if λ> ν (where λ = changes in blood glucose from peak to nadir, χ = number of valid observations, ν = 1 standard deviation of the mean glucose during a period of 24 hours) from the data of continuous monitoring of the tissue glucose, obtained during the period of measurement.|Week 12|Analysis set includes all randomized patients excluding the ones who were prematurely withdrawn and the ones who have no data from visit 7 which required for comparison.|||mg/dL||Standard Deviation|Mean
2614781|NCT02007252|Primary|Change From Baseline in Abdominal Aortic Aneurysm (AAA) Size Per Year|Size of the AAA was determined using an abdominal ultrasound technique at baseline, 3 months, and 12 months after treatment with study drug. Growth rate (in mm/year) was calculated from the change in AAA size compared to baseline|month 3, month 12|The pharmacodynamic analysis set, which included randomized participants who received at least one dose of study drug, was considered for the analysis. However, only participants with values at each time point were analyzed.|||millimeter/year||90% Confidence Interval|Least Squares Mean
2614782|NCT02007200|Secondary|The Number of Participants Alive Without Relapse at Last Follow-up|Relapse-free survival will be determined at the last follow-up visit.|Up to 24 months|55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.|||participants|||Number
2614783|NCT02007200|Secondary|The Number of Participants Alive at Follow-up|Overall survival at last follow-up will be determined.|Up to 24 months|55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.|||participants|||Number
2614784|NCT02007200|Primary|Correlations of Tumor p16 Methylation Status With Serum/Saliva Markers of p16, IL6, and VEGF|Each of the tumor and mucosal markers will be dependent variables in repeated measures models that include serum and saliva markers as predictors. Graphical analyses will be used to characterize possible nonlinear relationships between variables. Linear or nonlinear regression, as appropriate, will be used to characterize the relationship between the putative predictors and outcomes. Subset analyses, considering, for example, differences in relationships between tumor markers and serum and saliva markers between smokers and non-smokers will be performed by means of indicator variables.|Up to 12 months|We are seeking additional funding to hire the personnel to perform the serum/saliva markers. Until further notice markers will be unable to be analyzed.||||||
2614785|NCT02007200|Primary|Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone|The change in methylation will be analyzed in parallel using a linear repeated measures model. The fixed effects will be time (pre-treatment versus post-treatment), current smoking status (yes or no), their interaction, and tissue type (tumor or not). Satterthwaite's adjustment to the degrees of freedom will be applied to account for heteroscedasticity. The differential effect of soy isoflavone on tumor and non-tumor tissues between smokers and non-smokers will be assessed using linear contrasts.|From baseline to surgery, up to 42 days|55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.|||Percent change||Full Range|Mean
2614786|NCT02007109|Secondary|Pain and/or Nausea/Vomiting Rescue Needed|Incidence and/of pain or nausea/vomiting rescue medications administered during time in the PACU|Time in the PACU||||Participants|||Count of Participants
2614787|NCT02007109|Secondary|Subjects Who Experienced Nausea and/or Vomiting After Discharge (PDNV)|The study design is a cross sectional study of patients undergoing surgery. There will be no group assignment, no placebo group and each patient will be his or her own control. All patients will be asked to assess their pain and nausea using the visual analogue scales, the modified faces scale and the BARF scale as described below in the preoperative and postoperative areas.|First 24 postoperative hours||||Participants|||Count of Participants
2614788|NCT02007109|Primary|Incidence of Postoperative Nausea and/or Vomiting (PONV) in the Postanesthesia Care Unit (PACU)|"Subjects rated their pain and nausea at these time points: (1) upon waking in the PACU, (2) just before and (3) 30-60 mins after receiving analgesic or antiemetic therapy, and (4) upon discharge from PACU.~Scales range from 0 to 10 (lower scores indicate no pain or nausea)."|When awake and responding to commands in the post-anesthesia care unit (PACU)|Some PACU data is partial due to subjects being uncooperative at times (n=5) or being asleep until just before discharge (n=2)|||units||Full Range|Mean
2614789|NCT02007096|Secondary|Pain Score|"Post-operative Patient Self-Reported Pain Score. Patient self-reported pain scores when resting and when actively moving. Scale of 0 to 10, with 0 being no pain and 10 being the most pain you have ever experienced."|24 hours postoperatively||||units on a scale||Standard Deviation|Mean
2614790|NCT02007096|Secondary|Operating Procedure Time|Total number of minutes for the procedure, not including anesthesia time.|Procedure begin time to procedure end time||||min||Standard Deviation|Mean
2614791|NCT02007096|Secondary|Pain Score|"Post-operative Patient Self-Reported Pain Score. Patient self-reported pain scores when resting and when actively moving. Scale of 0 to 10, with 0 being no pain and 10 being the most pain you have ever experienced."|1 hour postoperatively||||units on a scale||Standard Deviation|Mean
2614792|NCT02007096|Primary|Post-operative Opioid Use|Amount of opioids used by patients at certain time points.|up to 24 hours||||mg||Standard Deviation|Mean
2614793|NCT02007070|Secondary|DOR Per irRC in PD-L1 Positive Participants|DOR was measured from the time measurement criteria were first met for irCR/irPR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). PD was defined as at least a 25% increase in SPD relative to minimum recorded tumor burden. Confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented was required. DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method, is reported in days and is presented for all PD-L1 positive participants who experienced an irCR or irPR.|Up to 2 years|The ATS population for this outcome measure consisted of all PD-L1 positive participants who received at least one dose of study drug and experienced a confirmed response.|||Days||Full Range|Median
2614794|NCT02007070|Secondary|PFS Per irRC in PD-L1 Positive Participants|PFS was defined as the time from the first day of study treatment to the first documented disease progression per irRC or death due to any cause, whichever occurred first. Using irRC, progressive disease was defined as at least a 25% increase in SPD relative to minimum recorded tumor burden. Confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented was required. Median PFS was analyzed using the Kaplan-Meier method and is presented in months for all PD-L1 positive participants.|Up to 2 years|The ATS population for this outcome measure consisted of all PD-L1 positive participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2614795|NCT02007070|Secondary|ORR Per irRC in PD-L1 Positive Participants|ORR per irRC was defined as the percentage of participants in the analysis population who had a irCR (Complete disappearance of all tumor lesions [whether measureable or not, and no new lesions; irCR must be confirmed by repeated, consecutive assessments made no less than 4 weeks from the date first documented]) or irPR (Decrease in sum of the products of the two largest perpendicular diameters [SPD] of 50% or greater by a consecutive assessment at least 4 weeks after first documentation). The percentage of PD-L1 positive participants who experienced an irCR or irPR is presented.|Up to 2 years|The ATS population for this outcome measure consisted of all PD-L1 positive participants who received at least one dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
2614796|NCT02007070|Secondary|OS in PD-L1 Positive Participants|OS was defined as the time from the first day of study treatment to death due to any cause. OS is reported for all PD-L1 positive participants in months.|Up to 2 years|The ATS population for this outcome measure consisted of all PD-L1 positive participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2614797|NCT02007070|Secondary|DOR by RECIST 1.1 in PD-L1 Positive Participants|DOR was measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed using the Kaplan-Meier method and is reported in days. The median DOR for all PD-L1 positive participants with a confirmed response is presented.|Up to 2 years|The ATS population for this outcome measure consisted of all PD-L1 positive participants who received at least one dose of study drug and experienced a confirmed response.|||Days||Full Range|Median
2614798|NCT02007070|Secondary|PFS by RECIST 1.1 in PD-L1 Positive Participants|PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists' review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months. The median PFS for all PD-L1 positive participants is presented.|Up to 2 years|The ATS population for this outcome measure consisted of all PD-L1 positive participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2614799|NCT02007070|Secondary|ORR Per RECIST 1.1 in PD-L1 Positive Participants|On-study imaging was to be performed every 9 weeks after the first dose of study drug, or more frequently if clinically indicated. ORR was defined as the percentage of participants in the analysis population who had a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The percentage of PD-L1 positive participants who experienced a CR or PR is presented.|Up to 2 years|The FAS population for this outcome measure consisted of all participants who were classified as PD-L1 positive, received at least one dose of study drug and had Baseline data for the analyses that required Baseline data.|||Percentage of Participants||95% Confidence Interval|Number
2614800|NCT02007070|Secondary|DOR Per irRC in Strongly PD-L1 Positive Participants|DOR was measured from the time measurement criteria were first met for irCR/irPR (whichever was first recorded) until the first date that recurrent or progressive disease (PD) was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). PD was defined as at least a 25% increase in SPD relative to minimum recorded tumor burden. Confirmation by a repeat, consecutive assessment no less than 4 weeks from the data first documented was required. DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method, is reported in days and is presented for all strongly PD-L1 positive participants who experienced an irCR or irPR.|Up to 2 years|The ATS population for this outcome measure consisted of all strongly PD-L1 positive participants who received at least one dose of study drug and experienced a confirmed response.|||Days||Full Range|Median
2614813|NCT02006979|Primary|Global Longitudinal Strain|Assessed with 2D speckle tracking echocardiography|24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle||||% deformation||Standard Deviation|Mean
2614840|NCT02006758|Secondary|Mean Change in Office Diastolic Blood Pressure at 1 Month||Baseline and 1 month|61 out of 67 analyzed for mean change in office Diastolic Blood Pressure at 1 month|||mmHg||Standard Deviation|Mean
2614841|NCT02006758|Secondary|Mean Change in Office Systolic Blood Pressure at 1 Month||Baseline and 1 month|61 out of 67 participants were analyzed for mean reduction in office Systolic Blood Pressure at 1 month.|||mmHg||Standard Deviation|Mean
2614802|NCT02007070|Secondary|ORR Per Immune-Related Response Criteria (irRC) in Strongly PD-L1 Positive Participants|ORR per irRC was defined as the percentage of participants in the analysis population who had a Complete Response (irCR: Complete disappearance of all tumor lesions [whether measureable or not, and no new lesions; irCR must be confirmed by repeated, consecutive assessments made no less than 4 weeks from the date first documented]) or Partial Response (irPR: Decrease in sum of the products of the two largest perpendicular diameters [SPD] of 50% or greater by a consecutive assessment at least 4 weeks after first documentation). The percentage of strongly PD-L1 positive participants who experienced an irCR or irPR is presented.|Up to 2 years|The ATS population for this outcome measure consisted of all strongly PD-L1 positive participants who received at least one dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
2614803|NCT02007070|Secondary|Overall Survival (OS) in Strongly PD-L1 Positive Participants|OS was defined as the time from the first day of study treatment to death due to any cause. OS is reported for all strongly PD-L1 positive participants in months|Up to 2 years|The ATS population for this outcome measure consisted of all strongly PD-L1 positive participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2614804|NCT02007070|Secondary|Duration of Response (DOR) by RECIST 1.1 in Strongly PD-L1 Positive Participants|DOR was measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. The lower and upper limits were estimated at the time of data cutoff. DOR was analyzed using the Kaplan-Meier method and is reported in days. The median DOR for all strongly PD-L1 positive participants with a confirmed response is presented.|Up to 2 years|The ATS population for this outcome measure consisted of all strongly PD-L1 positive participants who received at least one dose of study drug and experienced a confirmed response.|||Days||Full Range|Median
2614805|NCT02007070|Secondary|Progression Free Survival (PFS) by RECIST 1.1 in Strongly PD-L1 Positive Participants|PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists' review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months. The median PFS for all strongly PD-L1 positive participants is presented.|Up to 2 years|The ATS population for this outcome measure consisted of all strongly PD-L1 positive participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2614806|NCT02007070|Primary|Number of Participants Discontinuing Study Drug Due to AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. The number of participants who discontinued study drug due to an AE is presented.|Up to 2 years|The ATS population consisted of all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2614807|NCT02007070|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. After discontinuation of study drug, each participant was monitored for a minimum of 30 days for AE monitoring (serious AEs were monitored for up to 90 days after last dose of study drug). The number of participants who experienced an AE is presented.|Up to 27 months (Up to 90 days after last dose of study drug)|The All Treated Set (ATS) population consisted of all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2614808|NCT02007070|Primary|Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Strongly PD-L1 Positive Participants|On-study imaging was to be performed every 9 weeks after the first dose of study drug, or more frequently if clinically indicated. ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The percentage of strongly PD-L1 positive participants who experienced a CR or PR is presented.|Up to 2 years|The Full Analysis Set (FAS) population consisted of all participants who were classified as strongly PD-L1 positive, received at least one dose of study drug and had Baseline data for the analyses that required Baseline data.|||Percentage of Participants||95% Confidence Interval|Number
2614809|NCT02006979|Other Pre-specified|Patient-reported Symptoms|As assessed by standardized scores of physical and psychological distress by the Rotterdam Symptom Checklist|<1 week before the first doxorubicin, <3 days before the 2nd, 3rd, and 4th doxorubicin, 7-14 days after completion of the last doxorubicin cycle|||||||
2614810|NCT02006979|Secondary|LV Twist|Assessed with 2D speckle tracking echocardiography|24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle||||degrees||Standard Deviation|Mean
2614811|NCT02006979|Secondary|Cardiac Troponin T|biomarker of cardiac injury|24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle||||pg/mL||Standard Deviation|Mean
2614812|NCT02006979|Secondary|NT-proBNP|biomarker of cardiac injury|24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle||||pg/mL||Standard Deviation|Mean
2614814|NCT02006888|Primary|Number of Participants With Anterior Chamber Cell Clearing|The primary efficacy outcome is anterior chamber cell clearing in the study eye at Day 8. The slit lamp examination for anterior chamber cells (ACC) is a recognized way to measure inflammation in the anterior chamber. During the slit lamp examination, the number of anterior chamber cells are quantified and graded: grade 0 (absent, 0 cells), grade 1 (1 to 5 cells), grade 2 (6 to 15 cells), grade 3 (16 to 30+ cells), or grade 4 (hypopyon). Anterior chamber cell clearing occurs when all the ACC are absent (grade 0).|Day 8||||Participants|||Count of Participants
2614815|NCT02006836|Primary|AUCs With/Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. Capillary blood samples were detected before and after meals, 10pm, and 3am. Mean of each time point(before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner,10pm, and 3am ) of blood glucose concentrations on 4th to 6th day（without pomelo） were calculated and so as each time point of blood glucose concentrations on 7th to 9th day (with pomelo). Areas under the curves (AUC) of mean blood glucose concentrations of each time point were obtained with/without pomelo.|9 days||||mmol*hour/L||Standard Deviation|Mean
2614816|NCT02006836|Primary|∆g of Dinner With/Without Pomelo|"After the dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, there were 3-day CSII treatment without change of insulin dose. Capillary blood samples were detected before and after meals. Glucose difference (∆g) before and after dinner were obtained and analyzed.~g of dinner without pomelo=mean of 3 days of postprandial blood glucose after dinner without pomelo - mean of 3 days of blood glucose before this dinner.~g of dinner with pomelo=mean of 3 days of postprandial blood glucose after dinner with pomelo - mean of 3 days of blood glucose before this dinner."|9 days||||mmol/l||Standard Deviation|Mean
2614817|NCT02006836|Primary|∆g of Lunch With/Without Pomelo|"After the dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, there were 3-day CSII treatment without change of insulin dose. Capillary blood samples were detected before and after meals. Glucose difference (∆g) before and after lunch were obtained and analyzed.~g of lunch without pomelo=mean of 3 days of postprandial blood glucose after lunch without pomelo - mean of 3 days of blood glucose before this lunch.~g of lunch with pomelo=mean of 3 days of postprandial blood glucose after lunch with pomelo- mean of 3 days of blood glucose before this lunch."|9 days||||mmol/l||Standard Deviation|Mean
2614818|NCT02006836|Primary|∆g of Breakfast With/Without Pomelo|"After the dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, there were 3-day CSII treatment without change of insulin dose. Capillary blood samples were detected before and after meals. Glucose difference (∆g) before and after breakfast were obtained and analyzed.~g of breasfast without pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast.~g of breasfast with pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast."|9 days|The patients met the inclusion/exclusion criteria and completed the study.|||mmol/l||Standard Deviation|Mean
2614819|NCT02006836|Primary|Glycemic Index|"Glycemic index (GI) measurement was carried out after an overnight fast on 2 occasions in every subject, each test being separated from the next by a washout day.The first test day utilized 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of the Majia pomelos. Venous blood samples were collected and monitored during 3 hrs for both the healthy and T2DM individuals at 0, 30, 60, 90, 120, 150, and 180 min. Areas under the curves (AUC) of blood glucose concentrations were obtained. The 50 g of glucose was used as the reference (GI = 100) according to the literature. The AUC under the incremental glycemic-response curves for Majia were expressed as a percentage of the areas under the glucose curves for the same subject. The resulting values for all subjects were averaged to calculate the GI.~GI measurement is only calculated in case-control period."|3 days||||percentage of AUC from GI100||Standard Deviation|Mean
2614820|NCT02006758|Post-Hoc|Number of Anti-hypertensive Medications Participant Currently Takes at 12 Months||12 months|55 out of 67 participants were analyzed for number of anti-hypertensive medications taken at 12 months|||number of medications||Standard Deviation|Mean
2614821|NCT02006758|Post-Hoc|Urine Albumin to Creatinine Ratio at 12 Months||12 months|14 out of 67 analyzed for serum creatinine concentration at 6 months.|||mg/g||Standard Deviation|Mean
2614822|NCT02006758|Post-Hoc|Urine Albumin to Creatinine Ratio at 6 Months||6 months|17 out of 67 analyzed for serum creatinine concentration at 6 months.|||mg/g||Standard Deviation|Mean
2614823|NCT02006758|Post-Hoc|Serum Creatinine Concentration at 12 Months||12 months|46 out of 67 analyzed for serum creatinine concentration at 6 months.|||umol||Standard Deviation|Mean
2614824|NCT02006758|Post-Hoc|Serum Creatinine Concentration at 6 Months||6 months|55 out of 67 analyzed for serum creatinine concentration at 6 months.|||umol||Standard Deviation|Mean
2614825|NCT02006758|Secondary|Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 12 Months||12 months|55 out of 67 participants were analyzed for percentage of subjects achieving office Systolic Blood Pressure < 140 mmHg at 12 months|||Participants|||Count of Participants
2614826|NCT02006758|Secondary|Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months||6 months|59 out of 67 participants were analyzed for percentage of subjects achieving office Systolic Blood Pressure < 140 mmHg at 6 months|||Participants|||Count of Participants
2614827|NCT02006758|Secondary|Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months||Baseline and 12 months|25 out of 67 participants analyzed for mean change in ambulatory Diastolic Blood Pressure at 12 months|||mmHg||Standard Deviation|Mean
2614828|NCT02006758|Secondary|Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months||Baseline and 6 months|29 out of 67 participants analyzed for mean change in ambulatory Diastolic Blood Pressure at 6 months|||mmHg||Standard Deviation|Mean
2614829|NCT02006758|Secondary|Mean Change in Ambulatory Systolic Blood Pressure at 12 Months||Baseline and 12 months|25 out of 67 participants analyzed for mean change in ambulatory Systolic Blood Pressure at 12 months|||mmHg||Standard Deviation|Mean
2614830|NCT02006758|Secondary|Mean Change in Ambulatory Systolic Blood Pressure at 6 Months||Baseline and 6 months|29 out of 67 participants analyzed for mean change in ambulatory Systolic Blood Pressure at 6 months|||mmHg||Standard Deviation|Mean
2614844|NCT02006732|Secondary|FVC AUC0-3h Response (Change From Baseline)|The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS|||L||Standard Error|Mean
2614845|NCT02006732|Secondary|TDI Focal Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352|"This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 as specified in the analysis plan. Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9).~The adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks|Patients from FAS after combining the data from this and the replicate study NCT01964352|||Units on a scale||Standard Error|Mean
2614846|NCT02006732|Secondary|TDI Focal Score Based on Data From This Individual Study|"Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9).~The adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks|Patients from FAS|||Units on a scale||Standard Error|Mean
2614847|NCT02006732|Secondary|Trough Forced Vital Capacity (FVC) Response (Change From Baseline)|Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FVC measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FVC response was defined as trough FVC minus baseline FVC. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS|||L||Standard Error|Mean
2614848|NCT02006732|Primary|St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Combined Dataset From This Study and the Replicate Study NCT01964352|"This endpoint was evaluated after combining the data from this and the replicate study NCT01964352 as specified in the analysis plan. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks treatment|Patients from FAS after combining the data from this and the replicate study NCT01964352|||units on a scale||Standard Error|Mean
2614849|NCT02006732|Primary|St. George's Respiratory Questionnaire (SGRQ) Total Score Based on Data From This Individual Study|"The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks treatment|Patients from FAS|||units on a scale||Standard Error|Mean
2614850|NCT02006732|Primary|Trough FEV1 Response (Change From Baseline)|Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FEV1 measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FEV1 response was defines as trough FEV1 minus baseline FEV1. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS|||L||Standard Error|Mean
2614851|NCT02006732|Primary|FEV1 AUC0-3h Response|Forced expiratory volume in one second (FEV1) Area under the curve (AUC) 0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in litres. FEV1 AUC0-3h response was defined as FEV1 AUC0-3h minus baseline FEV1. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from the Full Analysis Set (FAS): This patient set included all randomized and treated patients who had a baseline and at least one postbaseline measurement for any of the primary efficacy endpoints.|||L||Standard Error|Mean
2614852|NCT02006719|Secondary|Investigator Assessment of Improvement With Treatment at Day 95|Investigator assessment of degree of improvement in severity of the participant's treated shoulder compared with screening rated as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.|Day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 10 participants also excluded for incomplete questionnaire|||participants|||Number
2615133|NCT02004366|Primary|Differences in Glycemic Control|Determine differences in glycemic control as measured by mean daily BG concentration between linagliptin alone and basal bolus therapy group.|Inpatient (average 5 days) and outpatient up to 12 weeks||||mg/dl||Standard Deviation|Mean
2614853|NCT02006719|Secondary|Subject Satisfaction With Treatment at Day 95|Participant assessment of satisfaction with treatment rated as very satisfied, quite satisfied, neither satisfied nor dissatisfied, quite dissatisfied, or very dissatisfied.|Day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 11 participants not completing questionnaire also excluded|||participants|||Number
2614854|NCT02006719|Secondary|Change From Baseline to Day 95 in Adapted ASES Pain Subscale|"Pain subscale score ranging from 0-50, with 0 being greatest pain, derived from participant overall assessment of pain in response to How bad is the pain in your affected shoulder today? using an 11-point NRS where 0=no pain at all and 10=pain as bad as it can be and calculated as (10 - NRS score) x 5; adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation"|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 33 participants missing either baseline or day 95 pain subscale scores also excluded|||units on a scale||Standard Deviation|Mean
2614855|NCT02006719|Secondary|Change From Baseline to Day 95 in Passive External Rotation|PROM measurement using a goniometer to assess external rotation in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 passive external rotation measurement also excluded|||degrees||Standard Deviation|Mean
2614856|NCT02006719|Secondary|Change From Baseline to Day 95 in Passive Internal Rotation|PROM measurement using a goniometer to assess internal rotation in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 passive internal rotation measurement also excluded|||degrees||Standard Deviation|Mean
2614857|NCT02006719|Secondary|Change From Baseline to Day 95 in Active External Rotation|AROM measurement using a goniometer to assess external rotation in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 active external rotation measurement also excluded|||degrees||Standard Deviation|Mean
2614858|NCT02006719|Secondary|Change From Baseline to Day 95 in Active Internal Rotation|AROM measurement using a goniometer to assess internal rotation in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 active internal rotation measurement also excluded|||degrees||Standard Deviation|Mean
2614859|NCT02006719|Secondary|Change From Baseline to Day 95 in Passive Abduction|PROM measurement using a goniometer to assess abduction in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 passive abduction measurement also excluded|||degrees||Standard Deviation|Mean
2614860|NCT02006719|Secondary|Change From Baseline to Day 95 in Passive Forward Flexion|Passive range of motion (PROM) measurement using a goniometer to assess forward flexion in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 active forward flexion measurement also excluded|||degrees||Standard Deviation|Mean
2614861|NCT02006719|Secondary|Change From Baseline to Day 95 in Active Abduction|AROM measurement using a goniometer to assess abduction in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 active abduction measurement also excluded|||degrees||Standard Deviation|Mean
2614862|NCT02006719|Secondary|Change From Baseline to Day 95 in Pain With Movement Using 11-point Numeric Rating Scale (NRS)|"Participant assessment of pain in response to How bad is the pain upon movement of your affected shoulder at its worst in the last 24 hours? using an 11-point NRS where 0=no pain at all and 10=pain as bad as it can be."|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 33 participants missing either baseline or day 95 pain with movement scores also excluded|||units on a scale||Standard Deviation|Mean
2614863|NCT02006719|Secondary|Change From Baseline to Day 95 in Adapted American Shoulder and Elbow Surgeons (ASES) Function Subscale|Function subscale score ranging from 0-50, with 0 being most dysfunctional, derived from participant assessment of ability to do 10 activities with affected shoulder/arm where 0=unable to do to, 1=very difficult to do, 2=somewhat difficult, and 3=not difficult, and calculated as (cumulative total score for the 10 activity items) × (5/3); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation (United States adapted version).|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 34 participants missing either baseline or day 95 function subscale scores also excluded|||units on a scale||Standard Deviation|Mean
2614864|NCT02006719|Primary|Change From Baseline to Day 95 in Active Forward Flexion|Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder|Baseline, day 95|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (1 participant excluded); 25 participants missing either baseline or day 95 active forward flexion measurement also excluded|||degrees||Standard Deviation|Mean
2620545|NCT01954160|Secondary|Resting Plasma Norepinephrine||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2614865|NCT02006706|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 24|PP Population|||score on a scale||Standard Deviation|Mean
2614866|NCT02006706|Primary|Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24|DAS28 was calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant-rated arthritis activity assessment using visual analog scale [VAS]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Baseline, Week 24|Per Protocol (PP) Population: included all participants who received at least one dose of study drug and who did not have any protocol violations.|||score on a scale||Standard Deviation|Mean
2614867|NCT02006693|Primary|Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24|The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 24 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.|Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)|mITT Population included all eligible eyes that met IOP and IOP-lowering medication inclusion criteria and received the XEN45 implant. Number analyzed is the number of eyes with data at the given time-point.|||medications|eyes|Standard Deviation|Mean
2614868|NCT02006693|Primary|Mean Change From Baseline in IOP in the Study Eyes to Month 24|IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.|Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)|mITT Population included all eligible eyes that met IOP and IOP-lowering medication inclusion criteria and received the XEN45 implant. Number analyzed is the number of eyes with data at the given time-point.|||mmHg|eyes|Standard Deviation|Mean
2614869|NCT02006693|Primary|Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12|The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 12 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.|Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)|mITT Population included all eligible eyes that met IOP and IOP-lowering medication inclusion criteria and received the XEN45 implant. Number analyzed is the number of eyes with data at the given time-point.|||medications|eyes|Standard Deviation|Mean
2614870|NCT02006693|Primary|Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12|IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.|Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)|mITT Population included all eligible eyes that met IOP and IOP-lowering medication inclusion criteria and received the XEN45 implant. Number analyzed is the number of eyes with data at the given time-point.|||mmHg|eyes|Standard Deviation|Mean
2614871|NCT02006667|Secondary|Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD)|Per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1): CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal [(short axis less than (<) 10 millimeters (mm)]. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as not qualifying for CR, PR, or Progressive Disease (PD).|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months|FAS|||percentage of participants|||Number
2614872|NCT02006667|Secondary|Percentage of Participants Surviving at 12 and 24 Months||Screening, and Months 12 and 24|FAS|||percentage of participants||95% Confidence Interval|Number
2614873|NCT02006667|Secondary|Overall Survival - Time to Event|The median time, in months, from the start of study treatment to OS event.|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months|FAS|||months||95% Confidence Interval|Median
2614874|NCT02006667|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the start of study treatment to date of death due to any cause.|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 36 months|FAS|||percentage of participants|||Number
2614875|NCT02006667|Primary|Percentage of Participants Who Were Progression Free at 12 and 24 Months||Screening, and Months 12 and 24|FAS|||percentage of participants||95% Confidence Interval|Number
2614876|NCT02006667|Primary|Progression-Free Survival - Time to Event|The median time, in months, from the first dose of study treatment to PFS event.|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months|FAS|||months||95% Confidence Interval|Median
2614877|NCT02006667|Primary|Progression-Free Survival (PFS) - Percentage of Participants With an Event|PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or death due to any cause.|Screening, Day 1 of Cycles 1 through 6, every 4 weeks until end of treatment, up to 33 months|FAS|||percentage of participants|||Number
2615430|NCT02000817|Secondary|Number of Participants With Anti-drug Antibody Binding|Samples were analyzed for the presence of anti-Otelixizumab antibodies using a validated immunoelectrochemiluminescent (ECL) assay.|Day-1, Month 3 and Month 6|Safety population|||Participants|||Number
2614878|NCT02006654|Secondary|Change in Health-related Quality of Life (EQ-5D VAS)|"Change from baseline to Week 24 in EQ-5D Visual Analogue Scale (EQ-5D VAS).~The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2614879|NCT02006654|Secondary|Change in Health-related Quality of Life (EQ-5D) Utility Score|"Change from baseline to Week 24 in EuroQol 5-dimensional (EQ-5D) utility score~The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). Each descriptive item is rated on a 3-point index ranging from 1 (no problems) to 3 (extreme problems) that is used for calculating a single summary index (from 0 to 1). A higher EQ-5D score indicates a worse outcome."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2614880|NCT02006654|Secondary|Change in Cognitive Aspects of Mental Function|"Change from baseline to Week 24 in Mini Mental State Examination (MMSE).~The Mini Mental State Examination (MMSE) is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2614881|NCT02006654|Secondary|Clinical Worsening|Clinical worsening at Week 24 (Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog above or equal to 4, change in ADCS-ADL23 below 0, and ADCS-CGIC above 4])|Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||Participants|||Count of Participants
2614882|NCT02006654|Secondary|Clinical Improvement|Clinical response at Week 24 (based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog below or equal to -4, change in ADCS-ADL23 at least 0, and ADCS-CGIC below or equal to 4])|Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||Participants|||Count of Participants
2614883|NCT02006654|Secondary|Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline|"Change from baseline to Week 24 in NPI anxiety item score in patients with an NPI anxiety item score of at least 2 at baseline~The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total score for the NPI anxiety item ranges from 0-12 (frequency multiplied by severity), where a higher score represents a worse outcome."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome/item measure assessed|||units on a scale||Standard Error|Least Squares Mean
2614884|NCT02006654|Secondary|Change in Individual Behavioural Disturbance Items|"Change in single NPI item scores at Week 24.~The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). Total score for each single NPI item ranges from 0-12 (frequency multiplied by severity), where higher scores represent worse outcome."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure/item assessed|||units on a scale||Standard Error|Least Squares Mean
2614892|NCT02006641|Secondary|Number of Participants With Clinical Worsening|Clinical worsening at Week 24 (Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog above or equal to 4, change in ADCS-ADL23 below 0, and ADCS-CGIC above 4])|Week 24|All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||Participants|||Count of Participants
2615178|NCT02003963|Primary|Change in Visceral Adiposity|Assessed by magnetic resonance imaging|Baseline clinic visit (week 0) and final clinic visit (week 13)|Intent to treat. Three participants did not complete baseline or final MRI scan due to exceeding weight limit or metal-containing object in the body, and five participants refused to complete final MRI scan.|||kg||Standard Deviation|Mean
2614885|NCT02006654|Secondary|Change in Behavioural Disturbance|"Change from baseline to Week 24 in Neuropsychiatric Inventory (NPI) total score~The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total NPI score is the frequency ratings multiplied by the severity ratings and ranges from 0 to 144 (higher score indicates worse outcome)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2614886|NCT02006654|Secondary|Change in Daily Functioning|"Change from baseline to Week 24 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score.~The Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) is a 23-item clinician-rated inventory to assess activities of daily living (conducted with a caregiver or informant). Each item comprises a series of hierarchical sub-questions, ranging from the highest level of independent performance to a complete loss for each activity. Total score of the 23 items ranges from 0 to 78 (higher score indicates lower disability)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2614887|NCT02006654|Secondary|Change in Global Impression|"Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 24.~The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change is a semi-structured interview to assess clinically relevant changes in patients with AD. The items determine cognition, behavior, social and daily functioning. Severity at baseline is rated on a 7-point scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). The clinically relevant change from baseline is rated on a 7-point scale from 1 (marked improvement) to 7 (marked worsening)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2614888|NCT02006654|Primary|Change in Cognition|"Change from baseline to Week 24 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score.~The Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog) is a 11-item neuropsychological test that assess the severity of cognitive impairment. The items determine the patient's orientation, memory, language, and praxis. Total score of the 11 items range from 0 to 70 (lower score indicates lower cognitive impairment)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2614889|NCT02006641|Secondary|Change in Health-related Quality of Life (EQ-5D VAS)|"Change from baseline to Week 24 in EQ-5D Visual Analogue Scale (EQ-5D VAS).~The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2614890|NCT02006641|Secondary|Change in Health-related Quality of Life (EQ-5D) Utility Score|"Change from baseline to Week 24 in EuroQol 5-dimensional (EQ-5D) utility score~The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). Each descriptive item is rated on a 3-point index ranging from 1 (no problems) to 3 (extreme problems) that is used for calculating a single summary index (from 0 to 1). A higher EQ-5D score indicates a worse outcome."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2614891|NCT02006641|Secondary|Change in Cognitive Aspects of Mental Function|Change from baseline to Week 24 in Mini Mental State Examination (MMSE). The Mini Mental State Examination (MMSE) is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2614935|NCT02006576|Other Pre-specified|Will Ibuprofen, 600 mg Three Times Daily, Increase Pro-collagen Peptide Fragment Concentrations in the Alveolar Portion of BAL Fluid in Subjects to the Range Observed in Normal Individuals or to Higher Levels?|Pro-collagen peptide fragment concentrations will be measured by ELISA in alveolar fluids obtained at randomization and again 12 weeks after randomization to determine if levels reach those of normal individuals or reach even higher levels.|12 weeks after randomization|||||||
2614893|NCT02006641|Secondary|Number of Participants With Clinical Improvement|Clinical response at Week 24 (based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog below or equal to -4, change in ADCS-ADL23 at least 0, and ADCS-CGIC below or equal to 4])|Week 24|All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||Participants|||Count of Participants
2614894|NCT02006641|Secondary|Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline|"Change from baseline to Week 24 in NPI anxiety item score in patients with an NPI anxiety item score of at least 2 at baseline~The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total score for the NPI anxiety item ranges from 0-12 (frequency multiplied by severity), where a higher score represents a worse outcome."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome/item measure assessed|||units on a scale||Standard Error|Least Squares Mean
2614895|NCT02006641|Secondary|Change in Individual Behavioural Disturbance Items|"Change in single NPI item scores at Week 24.~The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). Total score for each single NPI item ranges from 0-12 (frequency multiplied by severity), where higher scores represent worse outcome."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure/item assessed|||units on a scale||Standard Error|Least Squares Mean
2614896|NCT02006641|Secondary|Change in Behavioural Disturbance|"Change from baseline to Week 24 in Neuropsychiatric Inventory (NPI) total score.~The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total NPI score is the frequency ratings multiplied by the severity ratings and ranges from 0 to 144 (higher score indicates worse outcome)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2614897|NCT02006641|Secondary|Change in Global Impression|"Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 24.~The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change is a semi-structured interview to assess clinically relevant changes in patients with AD. The items determine cognition, behavior, social and daily functioning. Severity at baseline is rated on a 7-point scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). The clinically relevant change from baseline is rated on a 7-point scale from 1 (marked improvement) to 7 (marked worsening)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2614898|NCT02006641|Secondary|Change in Daily Functioning|"Change from baseline to Week 24 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score.~The Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) is a 23-item clinician-rated inventory to assess activities of daily living (conducted with a caregiver or informant). Each item comprises a series of hierarchical sub-questions, ranging from the highest level of independent performance to a complete loss for each activity. Total score of the 23 items ranges from 0 to 78 (higher score indicates lower disability)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2614899|NCT02006641|Primary|Change in Cognition|"Change from baseline to Week 24 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score.~The Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog) is a 11-item neuropsychological test that assess the severity of cognitive impairment. The items determine the patient's orientation, memory, language, and praxis. Total score of the 11 items range from 0 to 70 (lower score indicates lower cognitive impairment)."|Baseline and Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least one valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2614992|NCT02005601|Secondary|Nausea Severity|Nausea severity measured using Likert scale ranging from 0 (none) to 10 (severe).|POD 1||||units on a scale||Standard Deviation|Mean
2614993|NCT02005601|Secondary|Total Daily Opioid Use (mg Oral Morphine Equivalents)|Total daily opioid use (including PO, PCEA, IV, subcutaneous, IV push) in mg oral morphine equivalents on POD 1.|POD 1||||mg oral morphine equivalents||Standard Deviation|Mean
2614900|NCT02006628|Primary|Change From Baseline To The End Of Treatment (Day 43) In Brief Assessment Of Cognition In Schizophrenia (BACS) Score|The BACS was an instrument used to assess the aspects of cognition found to be most impaired and most strongly correlated with outcome in participants with schizophrenia or related psychotic disorder. The BACS consisted of 6 domains: verbal memory (score range 0 to 75), working memory (score range 0 to 28), motor speed (score range 0 to 100), verbal fluency (score > 0, with no set maximum value), attention and speed of information processing (score range 0 to 110), and executive functions (score range 0 to 22). A score was obtained for each of the 6 domains. A composite summary score was then calculated as the arithmetic mean of the unweighted scores from the 6 domains. While there was not an upper limit on the composite score, overall, an increase in score was indicative of an improvement in cognition.|Day 1 through Day 43|ITT analysis set: all participants who provided informed consent, were randomized to 1 of the treatment groups, took at least 1 dose of IMP, and had post-baseline efficacy data. One placebo participant with a PANSS Total score <60 at Day 1 and 1 GWP42003 participant with no post-baseline efficacy data were excluded from the ITT analysis set.|||score on a scale||Standard Deviation|Mean
2614901|NCT02006628|Primary|Clinical Global Impression Improvement Scale (CGI-I) Values At Day 8 And End Of Treatment (Day 43)|The CGI-I was a 7-point scale that required the clinician to assess how much a participant's illness had improved or worsened relative the first assessment at the beginning of the intervention. This was rated on the following scale: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; or 7 = very much worse. Lower scores equated to improvement of symptoms.|Day 8 through Day 43|ITT analysis set: all participants who provided informed consent, were randomized to 1 of the treatment groups, took at least 1 dose of IMP, and had post-baseline efficacy data. One placebo participant with a PANSS Total score <60 at Day 1 and 1 GWP42003 participant with no post-baseline efficacy data were excluded from the ITT analysis set.|||score on a scale||Standard Deviation|Mean
2614902|NCT02006628|Primary|Change From Baseline To The End Of Treatment (Day 43) In The Clinical Global Impression Severity Scale (CGI-S)|The CGI-S was a 7-point scale that required the clinician to rate the severity of a participant's illness at the time of assessment, relative to the clinician's past experience of participants who had the same diagnosis. Considering total clinical experience, participants were assessed on severity of mental illness at the time of rating on the following scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill. Lower scores equated to milder severity of symptoms, that is, closer to psychologically normal.|Day 1 through Day 43|ITT analysis set: all participants who provided informed consent, were randomized to 1 of the treatment groups, took at least 1 dose of IMP, and had post-baseline efficacy data. One placebo participant with a PANSS Total score <60 at Day 1 and 1 GWP42003 participant with no post-baseline efficacy data were excluded from the ITT analysis set.|||score on a scale||Standard Deviation|Mean
2614903|NCT02006628|Primary|Change From Baseline To The End Of Treatment (Day 43) In The Scale For The Assessment Of Negative Symptoms (SANS)|The SANS assessed 5 symptom complexes to obtain clinical ratings of negative symptoms in participants with schizophrenia or related psychotic disorder. Symptom complexes were affective blunting, alogia (impoverished thinking), avolition/apathy, anhedonia/asociality, and disturbance of attention. Assessments were conducted on a 6-point scale (0 = not at all; 5 = severe). The total score could range from 0 to 125 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.|Day 1 through Day 43|ITT analysis set: all participants who provided informed consent, were randomized to 1 of the treatment groups, took at least 1 dose of IMP, and had post-baseline efficacy data. One placebo participant with a PANSS Total score <60 at Day 1 and 1 GWP42003 participant with no post-baseline efficacy data were excluded from the ITT analysis set.|||score on a scale||Standard Deviation|Mean
2614904|NCT02006628|Primary|Change From Baseline To The End Of Treatment (Day 43) In PANSS 'G' Score|The PANSS 'G' scale measured the severity of general psychopathology symptoms, including somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgement and insight, disturbance of violation, poor impulse control, preoccupation, and active social avoidance. Individual items were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total 'G' score could range from 16 to 112 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.|Day 1 through Day 43|ITT analysis set: all participants who provided informed consent, were randomized to 1 of the treatment groups, took at least 1 dose of IMP, and had post-baseline efficacy data. One placebo participant with a PANSS Total score <60 at Day 1 and 1 GWP42003 participant with no post-baseline efficacy data were excluded from the ITT analysis set.|||score on a scale||Standard Deviation|Mean
2614905|NCT02006628|Primary|Change From Baseline To The End Of Treatment (Day 43) In PANSS 'N' Score|The PANSS 'N' scale measured the severity of negative symptoms, including blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Individual items were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total 'N' score could range from 7 to 49 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.|Day 1 through Day 43|ITT analysis set: all participants who provided informed consent, were randomized to 1 of the treatment groups, took at least 1 dose of IMP, and had post-baseline efficacy data. One placebo participant with a PANSS Total score <60 at Day 1 and 1 GWP42003 participant with no post-baseline efficacy data were excluded from the ITT analysis set.|||score on a scale||Standard Deviation|Mean
2614906|NCT02006628|Primary|Change From Baseline To The End Of Treatment (Day 43) In PANSS 'P' Score|The PANSS 'P' scale measured the severity of positive symptoms, including delusions, conceptual disorganization, hallucinations, hyperactivity, grandiosity, suspiciousness/persecution, and hostility. Individual items were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total 'P' score could range from 7 to 49 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.|Day 1 through Day 43|ITT analysis set: all participants who provided informed consent, were randomized to 1 of the treatment groups, took at least 1 dose of IMP, and had post-baseline efficacy data. One placebo participant with a PANSS Total score <60 at Day 1 and 1 GWP42003 participant with no post-baseline efficacy data were excluded from the ITT analysis set.|||score on a scale||Standard Deviation|Mean
2614907|NCT02006628|Primary|Percentage Of PANSS Total Score Responders At End Of Treatment (Day 43)|The percentage of PANSS treatment responders, defined as participants with ≥20% improvement in PANSS Total score between baseline and End of Treatment, is presented. The percentage of participants was calculated by dividing the number of participants with a ≥20% improvement in PANSS Total score (yes) by the total number of participants.|Day 1 through Day 43|ITT analysis set: all participants who provided informed consent, were randomized to 1 of the treatment groups, took at least 1 dose of IMP, and had post-baseline efficacy data. One placebo participant with a PANSS Total score <60 at Day 1 and 1 GWP42003 participant with no post-baseline efficacy data were excluded from the ITT analysis set.|||Participants|||Count of Participants
2614908|NCT02006628|Primary|Change From Baseline To End Of Treatment (Day 43) In Positive And Negative Syndrome Scale (PANSS) Total Score|The PANSS was a 30-item medical scale completed by a trained rater that assessed the positive and negative symptoms of schizophrenia as well as symptoms of general psychopathology. The PANSS Total score was derived from the sum of the 30 items, which were rated on a 7-point scale, where 1 = absent and 7 = extreme. The total score is the summed total for each of the PANSS positive symptom ('P'), negative symptom ('N'), general psychopathology symptom ('G') scores and could range from 30 to 210 points, with lower scores equating to milder severity of symptoms, that is, closer to psychologically normal.|Day 1 through Day 43|ITT analysis set: all participants who provided informed consent, were randomized to 1 of the treatment groups, took at least 1 dose of IMP, and had post-baseline efficacy data. One placebo participant with a PANSS Total score <60 at Day 1 and 1 GWP42003 participant with no post-baseline efficacy data were excluded from the ITT analysis set.|||score on a scale||Standard Deviation|Mean
2614909|NCT02006576|Other Pre-specified|Will Measures of Inflammation Assessed at Study Initiation be Related to the Rate of Emphysema Progression Determined by the Change in FEV1 From the Time of Assessment in COPDGene to the Current Study (Estimated 3-6 Years)?||3-6 years after initial FEV1 assessment|||||||
2614910|NCT02006576|Other Pre-specified|Will Measures of Prostanoids Other Than PGE Assessed at Study Initiation be Related to the Rate of Emphysema Progression Determined by the Change in CT Quantified Lung Density From the Time of Assessment in COPDGene to the Current Study?||3-6 years from initial CT scan|||||||
2614911|NCT02006576|Other Pre-specified|Will BAL PGE Levels Assessed at Study Initiation be Related to the Rate of Emphysema Progression Determined by the Change in FEV1 From the Time of Assessment in COPDGene to the Current Study (Estimated 3-6 Years)?||3-6 years from initial FEV1 assessment|||||||
2614912|NCT02006576|Other Pre-specified|Will BAL PGE Levels Assessed at Study Initiation be Related to the Rate of Emphysema Progression Determined by the Change in CT Quantified Lung Density From the Time of Assessment in COPDGene to the Current Study (Estimated 3-6 Years)?||3-6 years from initial CT scan|||||||
2614913|NCT02006576|Other Pre-specified|Are There Differences Between Subjects With Clustered vs. Diffuse Emphysema?|PGE levels in BAL fluid, sputum and metabolites in blood and urine will be evaluated for differences between subjects with clustered versus diffuse emphysema. Procollagen peptides will be evaluated in BAL fluid between subjects with clustered versus diffuse emphysema. Eicosanoids (PGD, 6kPGF1a, TXB2) urine will be evaluated between subjects with clustered versus diffuse emphysema. Measures of inflammation will be evaluated between subjects with clustered versus diffuse emphysema. Does the response of PGE, measures of repair, response of other eicosanoids, and response of measures of inflammation change as a result of 600 mg three times daily of ibuprofen.|48 weeks after randomization|||||||
2614914|NCT02006576|Other Pre-specified|Are There Differences Between Subjects With Upper Lobe vs. Lower Lobe Emphysema?|PGE levels in BAL fluid, sputum and metabolites in blood and urine will be evaluated for differences between subjects with upper lobe vs. lower lobe emphysema. Procollagen peptides will be evaluated in BAL fluid between subjects with upper lobe vs. lower lobe emphysema. Eicosanoids (PGD, 6kPGF1a, TXB2) urine will be evaluated between subjects with upper lobe vs. lower lobe emphysema. Measures of inflammation will be evaluated between subjects with upper vs. lower lobe emphysema. Does the response of PGE, measures of repair, response of other eicosanoids, and response of measures of inflammation change as a result of 600 mg three times daily of ibuprofen.|48 weeks after randomization|||||||
2614915|NCT02006576|Other Pre-specified|Will Ibuprofen 600 mg Three Times Daily, Alter Health Status Assessed by the SGRQ or COPD Status Assessed by the CAT in Subjects With Emphysema ?||48 weeks after randomization|||||||
2614916|NCT02006576|Other Pre-specified|Will Ibuprofen 600 mg Three Times Daily Alter the Rate of COPD Exacerbations?||48 weeks after randomization|||||||
2614917|NCT02006576|Other Pre-specified|Will Ibuprofen 600 mg Three Times Daily Alter the Rate of Change of FEV1?||48 weeks after randomization|||||||
2614918|NCT02006576|Other Pre-specified|Will Ibuprofen 600 mg Three Times Daily Alter the Rate of Change of DLCO?||48 weeks after randomization|||||||
2614919|NCT02006576|Other Pre-specified|Will Ibuprofen 600 mg Three Times Daily Alter the Rate of Change of Emphysema Progression as Assessed by CT Scan?||48 weeks after randomization|||||||
2614920|NCT02006576|Other Pre-specified|Will Ibuprofen 600 mg Three Times Daily, Reduce the Eicosanoids Other Than PGE in Subjects With Emphysema Compared to Placebo in BAL and Induced Sputum?|LTB4, PGD, TXB2, and 6kPGF1a will be measured by HPLC in induced sputums and BAL's obtained prior to randomization and again 10-12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.|12 weeks after randomization|||||||
2614921|NCT02006576|Other Pre-specified|Are Levels of 6kPGF1a (the Primary Metabolite of Prostacyclin) Increased in the Alveolar Component of BAL Fluid in Patients With COPD? Are the Levels Related to FEV1 and/or Severity of Emphysema?|6kPGF1a will be measured by HPLC in alveolar fluids obtained at randomization and again 10-12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls. 6kPGF1a levels will be compared against FEV1 and severity of emphysema.|12 weeks after randomization|||||||
2614994|NCT02005601|Primary|NRS Pain With Ambulation at 2 Weeks|When considering the pain in the knee in which you are having/had surgery, on a scale of 0-10, with 0 being no pain and 10 being pain as bad as you can imagine, how would you describe your level of pain in the last 24 hours during ambulation?|2 weeks after surgery||||NRS pain score||Standard Deviation|Mean
2614922|NCT02006576|Other Pre-specified|Are Levels of TXB2 (the Primary Metabolite of Thromboxane) Increased in the Alveolar Component of BAL Fluid in Patients With COPD? Are the Levels Related to FEV1 and/or Severity of Emphysema?|TXB2 will be measured by HPLC in alveolar fluids obtained at randomization and again 10-12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls. TXB2 levels will be compared against FEV1 and severity of emphysema.|12 weeks after randomization|||||||
2614923|NCT02006576|Other Pre-specified|Are Levels of PGD Increased in the Alveolar Component of BAL Fluid in Patients With COPD? Are Levels of PGD in Alveolar Lavage Fluid Related to FEV1 and/or Severity of Emphysema?|PGD will be measured by HPLC in alveolar fluids obtained at randomization and again 10-12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls. PGD levels will be compared against FEV1 and severity of emphysema.|12 weeks after randomization|||||||
2614924|NCT02006576|Other Pre-specified|Will Ibuprofen 600 mg Three Times Daily, Reduce Concentrations of SP-d in Serum From Subjects With Emphysema Compared to Placebo?|SP-d will be measured by ELISA in serum specimens obtained at randomization, 12 weeks after randomization and 48 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group.|48 weeks after randomization|||||||
2614925|NCT02006576|Other Pre-specified|Will Ibuprofen 600 mg Three Times Daily, Reduce Concentrations of CRP in Serum From Subjects With Emphysema Compared to Placebo?|CRP will be measured by ELISA in serum specimens obtained at randomization, 12 weeks after randomization and 48 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group.|48 weeks after randomization|||||||
2614926|NCT02006576|Other Pre-specified|Will Ibuprofen 600 mg Three Times Daily, Reduce Concentrations of CC-16 in Serum From Subjects With Emphysema Compared to Placebo?|CC-16 will be measured by ELISA in serum specimens obtained at randomization, 12 weeks after randomization and 48 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group.|48 weeks after randomization|||||||
2614927|NCT02006576|Other Pre-specified|Will Ibuprofen 600 mg Three Times Daily, Alter LTB4 Concentrations in Subjects With Emphysema Compared to Placebo in the Alveolar Portion of BAL, Bronchial Portion of BAL and Induced Sputum?|LTB4 will be measured by HPLC in alveolar fluids, bronchial fluids and induced sputums obtained at randomization and again 10-12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.|12 weeks after randomization|||||||
2614928|NCT02006576|Other Pre-specified|Will Ibuprofen 600 mg Three Times Daily, Reduce PMN Concentrations in Induced Sputum From Subjects With Emphysema Compared to Placebo?|Neutrophils will be measured by 500 cell differentials in bronchial specimens obtained prior to randomization and 10 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.|10 weeks after randomization|||||||
2614929|NCT02006576|Other Pre-specified|Will Ibuprofen 600 mg Three Times Daily, Reduce PMN Concentrations in the Bronchial Portion of BAL Fluid in Subjects With Emphysema Compared to Placebo?|Neutrophils will be measured by 500 cell differentials in bronchial specimens obtained at randomization and 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.|12 weeks after randomization|||||||
2614930|NCT02006576|Other Pre-specified|Will Ibuprofen 600 mg Three Times Daily, Reduce IL-8 Concentrations in Induced Sputum From Subjects With Emphysema Compared to Placebo?|IL-8 will be measured by ELISA in sputum specimens obtained prior to randomization and 10 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.|10 weeks after randomization|||||||
2614931|NCT02006576|Other Pre-specified|Will Ibuprofen 600 mg Three Times Daily, Reduce IL-8 Concentrations in the Bronchial Portion of BAL Fluid in Subjects With Emphysema Compared to Placebo?|IL-8 will be measured by ELISA in bronchial specimens obtained at randomization and 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.|12 weeks after randomization|||||||
2614932|NCT02006576|Other Pre-specified|Will Ibuprofen, 600 mg Three Times Daily, Decrease Neutrophil Concentrations in the Alveolar Portion of BAL Fluid in Subjects With Emphysema in Comparison to Placebo?|Neutrophils will be measured by 500 cell differentials in alveolar specimens obtained at randomization and 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.|12 weeks after randomization|||||||
2614933|NCT02006576|Other Pre-specified|Will Ibuprofen, 600 mg Three Times Daily, Decrease IL-8 Concentrations in the Alveolar Portion of BAL Fluid in Subjects With Emphysema in Comparison to Placebo?|IL-8 will be measured by ELISA in alveolar specimens obtained at randomization and 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.|12 weeks after randomization|||||||
2614934|NCT02006576|Other Pre-specified|Will Ibuprofen 600 mg Three Times Daily, Increase the Procollagen III Amino Peptide Excreted Into the Urine of Subjects With Emphysema Compared to Placebo?|Procollagen III amino peptide will be measured by ELISA in urine specimens obtained at randomization, 12 weeks after randomization and 48 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group.|48 weeks after randomization|||||||
2615179|NCT02003963|Primary|Change in Body Fat|Assessed by dual energy x-ray absorptiometry|Baseline clinic visit (week 0) and final clinic visit (week 13)|Intent to treat|||kg||Standard Deviation|Mean
2614936|NCT02006576|Other Pre-specified|Will Ibuprofen 600 mg Three Times Daily, Reduce the PGE Metabolite PGEM in the Urine of Subjects With Emphysema Compared to Placebo?|PGEM will be measured by HPLC in urine specimens obtained at randomization, 12 weeks after randomization and 48 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.|48 weeks after randomization|||||||
2614937|NCT02006576|Other Pre-specified|Will Ibuprofen 600 mg Three Times Daily, Reduce the PGE Metabolite PGEM in the Peripheral Blood of Subjects With Emphysema Compared to Placebo?|PGEM will be measured by HPLC in peripheral blood specimens obtained at randomization, 12 weeks after randomization and 48 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.|48 weeks after randomization|||||||
2614938|NCT02006576|Other Pre-specified|Will Ibuprofen 600 mg Three Times Daily, Reduce Prostaglandin E Concentrations in Induced Sputum From Subjects With Emphysema Compared to Placebo?|PGE will be measured by HPLC in sputum samples obtained prior to randomization and again 10 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smokers and controls.|10 weeks after subject randomization|||||||
2614939|NCT02006576|Other Pre-specified|Will Ibuprofen 600 mg Three Times Daily, Reduce Prostaglandin E Concentrations in the Bronchial Portion of BAL Fluid in Subjects With Emphysema Compared to Placebo?|PGE will be measured by HPLC in bronchial fluids obtained at randomization and again 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls.|12 weeks after subject randomization|||||||
2614940|NCT02006576|Other Pre-specified|Will Ibuprofen, 600 mg Three Times Daily, Reduce Prostaglandin E Concentrations in the Alveolar Portion of BAL Fluid in Subjects With Emphysema to Those Present in Smoking, Former Smoking and Healthy Non-smoking Controls?|PGE will be measured by HPLC in alveolar fluids obtained at randomization and again 12 weeks after randomization on subjects taking ibuprofen to compare emphysema subjects, smokers, former smokers and controls.|12 weeks after subject randomization|||||||
2614941|NCT02006576|Secondary|Will Ibuprofen, 600 mg Three Times Daily, Increase Pro-collagen Peptide Fragment Concentrations in the Alveolar Portion of BAL Fluid in Subjects With Emphysema in Comparison to Placebo?|Pro-collagen peptide fragments will be measured by ELISA in alveolar fluids obtained at randomization (week 0) and again 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group.|12 weeks after subject randomization|This analysis limited to COPD Placebo vs. Ibuprofen groups only.|||Change in ng/ml||Standard Deviation|Mean
2614942|NCT02006576|Primary|Will Ibuprofen, 600 mg Three Times Daily, Decrease PGE Concentration in the Alveolar Portion of BAL Fluid in Subjects With Emphysema in Comparison to Placebo?|PGE will be measured by HPLC in alveolar fluids obtained at randomization (week 0) and again 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group.|12 weeks after subject randomization|Primary analysis limited to COPD Placebo vs. Ibuprofen groups only. The 'control' group is assessed once and serves as a comparator for the post treatment ibuprofen group.|||Change in ng/ml||Standard Deviation|Mean
2614943|NCT02006420|Secondary|Linear Relationship Between Ultrasound Skin Stiffness and MRSS|"Pearson correlation assesses the linear relationships between ultrasound skin stiffness and subjective skin scoring (MRSS) of skin stiffness. MRSS is the Modified Rodnan Score. Skin thickness is measured by clinical palpation using a 0-3 scale. 0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness with inability to pinch the skin into a fold.~Because MRSS measurements were not taken for healthy participants, no correlations are provided for them. Therefore, the correlations are based on a skin stiffness and skin scoring solely for scleroderma participants."|Cross-sectional study, 1 visit, <1 hr|Data for 2 of 24 participants is not available.|||correlation coefficient|||Number
2614944|NCT02006420|Secondary|MRSS Scores for Scleroderma Participants.|"MRSS scores exist on a scale from 0 to 51 based on scores of 0 to 3 measured in 17 locations on the body, where 0 represents overall healthy skin and 51 would be the worst outcome in all 17 locations.~MRSS measures are not taken on healthy participants."|Cross-sectional study, 1 visit, <1 hr|Of 24 scleroderma participants, data was not available for 2.|||units on a scale||Full Range|Mean
2614945|NCT02006420|Secondary|Linear Relationship Between Ultrasound Skin Stiffness and Landmark|Pearson correlation assesses the linear relationship between ultrasound skin stiffness and subjective skin scoring (Landmark) of skin stiffness in all patients (controls plus scleroderma). Data was combined for scleroderma and control subjects to assess the relationship and association across a broad range of skin conditions.|Cross-sectional study, 1 visit, <1 hr||||correlation coefficient|||Number
2614946|NCT02006420|Secondary|Mean Landmark Scores|Mean Landmark scores are on a scale of 0 to 3, 0 = normal and 3 =marked skin hardening.|Cross-sectional study, 1 visit, <1 hr||||units on a scale||Full Range|Mean
2614947|NCT02006420|Secondary|Linear Relationship Between Ultrasound Skin Stiffness and Durometer|"Pearson correlation assesses the linear relationship between Ultrasound skin stiffness measurements and Durometer scoring of skin stiffness.~Data was combined for scleroderma and control subjects to assess the relationship and association across a broad range of skin conditions."|Cross-sectional study, 1 visit, <1 hr||||Correlation coefficient|||Number
2614948|NCT02006420|Secondary|Mean Skin Stiffness as Measured by Durometer Scoring|Durometer scoring of skin stiffness in two groups of patients (controls and scleroderma). Durometer measurements are expressed in standardized international durometer units ranging from 0 to 100 where 100 is harder (worse outcome) The Rex Gauge model DD-3 was used. For further reference see Arthritis and Rheumatism (Arthritis Care & Research) Vol. 55. No. 4, August 15, 2006, pp. 603-609. DOI 10.1002/art.22093.|Cross-sectional study, 1 visit, <1 hr||||units on a scale||Standard Deviation|Mean
2614949|NCT02006420|Primary|Mean Skin Stiffness|Skin stiffness was measured from the forearm and thigh of patients with scleroderma using ultrasound shear wave velocity imaging. Shear wave velocity is measured in meters per second (m/s).|Cross-sectional study, 1 visit, <1 hr||||meters per second||Standard Deviation|Mean
2614950|NCT02006407|Secondary|Evaluate the Correlation Between Global COGState Scores, Radiation Dose, and the Perpendicular Diffusivity of Water as Measured by Diffusion Tensor Imaging at 6 Months|Determine the change in cognitive test scores from baseline, at 6 months using CogState (a computerized software testing system that offers various cognitive assessments based on expansive neurocognitive tests). Correlate test scores from COGState with changes in Diffusion Tensor Imaging (DTI) at the same timepoints (Baseline and 6 months) using scatter plots with Pearson and Spearman's correlation coefficients. As a pilot study multiple comparisons will be assessed; however, the working hypothesis based upon results in adults treated with radiation therapy is that DTI changes as measured by an increase in diffusivity of water perpendicular to the direction of axonal transport will correlate with changes in global response as measured on COGState with the sub-domains on executive function most highly correlated. In addition, these regional changes in DTI will be directly related to the radiation doses received in these regions.|6 months|Data can not be accessed due to technical difficulties with the COGState server.||||||
2614951|NCT02006407|Secondary|Evaluate the Correlation Between Global COGState Scores and the Perpendicular Diffusivity of Water by Diffusion Tensor Imaging at Baseline, 3 Weeks, and 6 Weeks Into Treatment.|Determine the change in cognitive test scores from baseline to time-points early during radiation therapy (3 and 6 weeks) using CogState (a computerized software testing system that offers various cognitive assessments based on expansive neurocognitive tests). Correlate test scores from COGState with changes in Diffusion Tensor Imaging (DTI) at the same timepoints using scatter plots with Pearson and Spearman's correlation coefficients. As a pilot study multiple comparisons will be assessed; however, the working hypothesis is that DTI changes as measured by an increase in diffusivity of water perpendicular to the direction of axonal transport will be measurable even in this acute setting and will correlate with global response as measured on COGState with the sub-domains on executive function anticipated to be most highly correlated.|Baseline, 3 weeks, and 6 weeks|Data can not be accessed due to technical difficulties with the COGState server.||||||
2614952|NCT02006407|Primary|Evaluate the Change From Baseline in Perpendicular Diffusivity of Water as Measured by Diffusion Tensor Imaging (DTI) at 3 Weeks and at 6 Weeks Post Radiation Therapy.|Descriptive statistics and plots will be used to determine Diffusion Tensor Imaging (DTI) parameters for various regions in the brain. The mean (across subject) change in DTI parameter for a given region, at a given time, will be used to assess white matter injury.|Baseline, 3 weeks, and 6 weeks|Because the outcome measure was CHANGE FROM BASELINE to 3 and 6 weeks, and data were not able to be collected at 3 and 6 weeks, the outcome measure could not be analyzed||||||
2614953|NCT02006342|Secondary|Number of Participants Who Developed Hypoglycemia|"To determine whether it is safe to administer both IV and subcutaneous insulin, it is important to assure that patient's glucose does not drop to critically low level and lead to adverse events. Hypoglycemia was defined as less than or equal to 60mg/dL during 24 hours after anion gap closure.~Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production."|Participants monitored during the 24 hours after anion gap closure|While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).|||participants|||Number
2614954|NCT02006342|Secondary|Hospital Length of Stay|Hospital length of stay was determined to assess whether a more efficient correction of the acidosis will result in decreased time that the patient is admitted to the hospital. Results reported are adjusted for age, hospital site, and etiology of diabetic ketoacidosis.|Participants monitored from hospital admission to discharge, an average of 4 days|While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).|||days||Standard Error|Mean
2614955|NCT02006342|Secondary|Intensive Care Unit Length of Stay|Determine the amount of time patient is admitted to the intensive care unit with the goal of assessing if more efficient correction of the acidosis results in decreased time in the intensive care unit for the patients.|Participants monitored from hospital admission to discharge, an average of 4 days|While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).|||days||Inter-Quartile Range|Median
2614956|NCT02006342|Secondary|Number of Participants Admitted to the ICU|The goal was to determine if the amount of patients admitted to the ICU could be reduced by providing more efficient resolution of the critical condition which is the acidosis.|Participants followed for the duration of the Emergency Department stay, an expected average of 12 hours|While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).|||participants|||Number
2614957|NCT02006342|Primary|Time to Anion Gap Closure|Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production. Results reported are adjusted for initial anion gap, etiology of diabetic ketoacidosis, and comorbidities.|Participants monitored from hospital admission to discharge, an average of 4 days|While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).|||hours||Standard Error|Mean
2614958|NCT02006264|Secondary|TFV-DP C-ave in Cervical Tissue|TFV-DP (tenofovir diphosphate) average concentration (C-ave) in cervical tissue. PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|before and after 14 days of vaginal ring use|PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|||fmol/mg||Inter-Quartile Range|Median
2614959|NCT02006264|Secondary|TFV C-ave in Cervical Tissue|TFV (tenofovir) average concentration (C-ave) in cervical tissue. PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|before and after 14 days of vaginal ring use|PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|||ng/mg||Inter-Quartile Range|Median
2614995|NCT02005562|Secondary|Participant Survival|Participants survival was defined as the percentage of participants living with or without a functioning graft between Weeks 0 and 52. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population|||percentage of participants|||Number
2614960|NCT02006264|Secondary|TDF AUC0-14 in CVF Genital Secretions (ECX and VAG), TFV AUC0-14 in CVF Genital Secretions (ECX and VAG), and TFV AUC0-14 in Plasma|TDF (tenofovir disoproxil fumarate) AUC0-14 (Area Under the Curve (concentration versus time) days 0-14) in Cervicovaginal Fluid (CVF) genital secretions (ectocervix (ECX) and vagina(VAG)), TFV AUC0-14 in CVF genital secretions (ECX and VAG), and TFV (tenofovir) AUC0-14 in Plasma. PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|1, 3, 7 and 14 days after ring insertion and 2 and 7 days after ring removal|TDF analytical data available for 13 of 15 participants for CVF ECX, and 14 of 15 participants for CVF VAG. TFV analytical data available for 13 of 15 participants for CVF ECX. PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|||ngxd/mL||Inter-Quartile Range|Median
2614961|NCT02006264|Secondary|TDF and TFV Time to Maximum Concentrations (T-max) in CVF Genital Secretions (ECX and VAG), and TFV Time to Maximum Concentration in Plasma|TDF (tenofovir disoproxil fumarate) and TFV (tenofovir) time to maximum concentrations (T-max) in CVF (Cervicovaginal Fluid) genital secretions (ectocervix (ECX) and vagina (VAG)), and TFV time to maximum concentration in Plasma. PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|1, 3, 7 and 14 days after ring insertion and 2 and 7 days after ring removal|TDF analytical data available for 14 of 15 participants for CVF VAG and CVF ECX. TFV analytical data available for 12 of 15 participants for Plasma. PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|||h||Inter-Quartile Range|Median
2614962|NCT02006264|Secondary|TDF and TFV Maximum Concentrations (C-max) in CVF Genital Secretions (ECX and VAG) and TFV Maximum Concentration in Plasma|TDF (tenofovir disoproxil fumarate) and TFV (tenofovir) maximum concentrations (C-max) in CVF (Cervicovaginal Fluid) genital secretions (ectocervix (ECX) and vagina (VAG)) and TFV maximum concentration (C-max) in plasma. PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|1, 3, 7 and 14 days after ring insertion and 2 and 7 days after ring removal|TDF analytical data available for 14 of 15 participants for CVF VAG and CVF ECX. PK parameters only measured in TDF IVR subjects, not Placebo IVR subjects.|||ng/mL||Inter-Quartile Range|Median
2614963|NCT02006264|Primary|Grade 2 or Higher Adverse Events as Defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events|Grade 2 or higher systemic and local Adverse Events as defined by the Division of Aids (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events during the trial period|14 days of vaginal ring use||||Adverse events|||Number
2614964|NCT02006264|Primary|Grade 1 Genitourinary Events or Higher as Defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events|Grade 1 or higher Genitourinary events as defined by the DAIDS (Division of AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events during the trial period judged to be related to study product|14 days of vaginal ring use||||Adverse events|||Number
2614965|NCT02006160|Primary|Symbol Digit Modalities Test|The Symbol Digit Modalities Test is a measure of cognitive processing speed. The outcome is the total number of correct digit substitutions in 90 seconds, with a possible total range of 0-120. Higher values reflect a better score/outcome than lower scores.|Week 0, Week 12||||score on a scale||Standard Deviation|Mean
2614966|NCT02006121|Secondary|Mean Change in Levodopa Equivalent Dose From Baseline to Visit 10 (Week 12) Using MMRM in the mITT Population|Levodopa equivalent dose is an indication of the burden of medication taken to control symptoms of Parkinson's disease with all medications other than levodopa itself being converted to a calculated levodopa dose using the methodology published by Tomlinson et al, 2010. The computation of LED excludes the study drug.|Baseline and 12 weeks|All randomized patients treated at least once with study medication and who had at least one post-baseline observation for the primary endpoint|||mg||95% Confidence Interval|Least Squares Mean
2614967|NCT02006121|Secondary|Mean Change in Oral Levodopa Dose From Baseline to Visit 10 Using MMRM for the mITT Population|The least squares mean change in oral levodopa dose from Baseline to Visit 10 (week 12) was calculated excluding 3 centres who declined to participate in collecting the necessary details of PRN use of levodopa.|Baseline and 12 weeks|All patients who received at least one dose of randomized study medication and had at least one post-baseline observation for the primary endpoint|||mg||95% Confidence Interval|Least Squares Mean
2614968|NCT02006121|Secondary|Patient Global Impression of Change (PGIC), Using the mITT Population|PGIC is a self-administered questionnaire measuring personal general state of health on a 7-point rating scale. The 7 ordinal categories from which patients must choose are 'very much improved', 'much improved', 'minimally improved', 'no change', 'minimally worse', 'much worse', and 'very much worse. Results are presented as the % of patients who reported at least minimal improvement in general health status at week 12 compared to Baseline. A Wilcoxon range sum test was performed to test for treatment differences from baseline to end of 12 weeks' treatment period.|Baseline and 12 weeks|All randomised patients excluding those who had major protocol deviations who received at least one dose of trial medication during the course of the trial and for whom any post-baseline efficacy assessment is available and who completed the PGIC questionnaire|||% of participants|||Number
2614969|NCT02006121|Secondary|"Mean Change in Daily Time Spent ON Without Troublesome Dyskinesia From Baseline to the End of the Double-blind Phase (Visit 10), Based on Patient Diaries Using MMRM mITT Population"|"The least squares mean change in ON time without troublesome dyskinesia as reported by the patient using the Hauser Parkinson's disease home diary. Each half hour of the day categorised as OFF, ON with dyskinesia, ON without troublesome dyskinesia or asleep. ON time without troublesome dyskinesia measures good ON time for a Parkinson's disease patient."|Baseline and 12 weeks|All randomised patients excluding those who had major protocol deviations who received at least one dose of trial medication during the course of the trial and for whom any post-baseline efficacy assessment is available.|||Hours||95% Confidence Interval|Least Squares Mean
2614996|NCT02005562|Secondary|Time to Graft Loss|The median time, in days, from randomization to graft loss event. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population|||days||Full Range|Median
2614997|NCT02005562|Secondary|Graft Loss - Percentage of Participants With an Event|Graft loss was defined as physical loss (nephrectomy), functional loss [necessitating maintenance dialysis for greater than (>)8 weeks], retransplant or death. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population|||percentage of participants|||Number
2614970|NCT02006121|Primary|Mean Change in Daily OFF Time From Baseline (Start of Blinded Treatment) to the End of Double-blind Phase (Visit 10) Based on Patient Diaries Using MMRM mITT Population|The least squares mean reduction (improvement) in OFF time as reported by the patient using the Hauser Parkinson's disease home diary. Patients categorised their motor symptoms into OFF, ON with dyskinesia, ON without troublesome dyskinesia or sleeping using half hour blocks over 24 hours. Daily OFF time was computed from the average of valid motor diaries from the two days preceding each visit. Correct diary completion was evaluated during screening and observed by the investigator to ensure patients could categorise their motor symptoms correctly. A diary was considered valid if no more than 4 half-hour periods were either absent or duplicated. There were no invalid diaries at Baseline or Week 12.|Baseline and 12 weeks|All randomised patients excluding those who had major protocol deviations who received at least one dose of trial medication during the course of the trial and for whom any post-baseline efficacy assessment is available.|||Hours||95% Confidence Interval|Least Squares Mean
2614971|NCT02006108|Secondary|Correlation of Cell-bound Iron Quantities on QSM Sequences With Macrophage and Iron Stains on Histopathology|To evaluate our ability to quantify cell-bound iron using the novel QSM sequence, we use histopathological data showing 1) the iron content of renal tissue sampled, and 2) the level of macrophage infiltration of the renal tissue. We will perform iron and macrophage stains in biopsy tissues in order to determine this.|3 weeks|CD163 positive macrophages|||correlation coefficient|||Number
2614972|NCT02006108|Primary|Radiologically Detectable Differences in Signal Intensity Between Healthy and Rejected Kidneys, Measured Using T2* Maps|According to the study hypothesis, macrophage infiltration into rejected kidneys will be significantly greater than in healthy kidneys; since macrophages are expected to phagocytose injected iron, there should be a detectable difference in signal intensity between healthy and rejected organs. This can be evaluated using semiquantitative T2* maps.|24 hours to 7 days|T2* value of transplant kidney|||ms (delayed postcontrast scans)||Standard Deviation|Mean
2614973|NCT02006056|Other Pre-specified|Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)|"Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the FLIE are reported from 1-7, with 1 being no symptoms and not at all for interference with life, and 7 being a great deal of symptom and interference with life.~Q1-9 are for nausea (N). Q 10-18 are for vomiting (V). All questions refer to during the past 3 days.~Q1/10: How much N/V have you had? Q2/11: Has N/V affected your ability to maintain usual recreation or leisure activities? Q3/12: Has N/V affected your ability to make a meal or do minor household repairs? Q4/13: How much has N/V affected your ability to enjoy a meal? Q5/14: How much has N/V affected your ability to enjoy liquid refreshment? Q6/15: How much has N/V affected your willingness to see and spend time with family/friends? Q7/16: Has N/V affected your daily functioning? Q8/17: Degree your N/V imposed hardship on you? Q9/18: Degree on your family?"|Day 7|Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined.|||units on a scale||Standard Error|Mean
2614974|NCT02006056|Other Pre-specified|Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)|"Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the FLIE are reported from 1-7, with 1 being no symptoms and not at all for interference with life, and 7 being a great deal of symptom and interference with life.~Q1-9 are for nausea (N). Q 10-18 are for vomiting (V). All questions refer to during the past 3 days.~Q1/10: How much N/V have you had? Q2/11: Has N/V affected your ability to maintain usual recreation or leisure activities? Q3/12: Has N/V affected your ability to make a meal or do minor household repairs? Q4/13: How much has N/V affected your ability to enjoy a meal? Q5/14: How much has N/V affected your ability to enjoy liquid refreshment? Q6/15: How much has N/V affected your willingness to see and spend time with family/friends? Q7/16: Has N/V affected your daily functioning? Q8/17: Degree your N/V imposed hardship on you? Q9/18: Degree on your family?"|Day 3|Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined.|||units on a scale||Standard Error|Mean
2614975|NCT02006056|Other Pre-specified|The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment.|Quality of life as measured by the EORTC QLQ-C15-PAL. For multiple fractions of radiotherapy, the questionnaire will be administered on Day 5 and 10 during treatment when applicable. Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the C15-PAL were scored on a scale of 0-100, with 0 representing no symptoms but low level of functioning and 100 representing severe symptoms and high degree of functioning.|Day 6-10 of treatment|Combined patients from primary prophylaxis and secondary prophylaxis arms, due to the low number of patients in the secondary prophylaxis arm (n=4).|||units on a scale||Standard Deviation|Mean
2614976|NCT02006056|Other Pre-specified|The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment.|Quality of life as measured by the EORTC QLQ-C15-PAL. For multiple fractions of radiotherapy, the questionnaire will be administered on Day 5 and 10 during treatment when applicable. Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the C15-PAL were scored on a scale of 0-100, with 0 representing no symptoms but low level of functioning and 100 representing severe symptoms and high degree of functioning.|Day 0-5 during treatment|The primary prophylaxis arm and secondary prophylaxis arm patients were combined and analysed together, because the secondary prophylaxis arm had only 4 patients, which was too low to draw any meaningful conclusions.|||units on a scale||Standard Deviation|Mean
2614998|NCT02005562|Secondary|Graft Histology - Percentage of Participants With at Least One Chronic Graft Nephropathy at Week 12 and Week 52|Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Weeks 12 and 52|ITT population|||percentage of participants|||Number
2614999|NCT02005562|Secondary|Graft Histology - Percentage of Participants With at Least One Borderline Lesion at Week 12 and Week 52|Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Weeks 12 and 52|ITT population|||percentage of participants|||Number
2614977|NCT02006056|Primary|Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.|"The primary objectives are to examine the efficacy for the prevention/rescue of Acute and Delayed Phase radiation-induced nausea and vomiting (RINV) in patients undergoing single or multiple fraction, emetogenic palliative radiation therapy for painful bone metastases.~Complete control: No increase in emetic episodes or increase in use of rescue medication (for secondary prophylaxis) following radiation treatment, compared to the number of incidences at baseline.~Partial control: Increase of 2 or fewer emetic episodes from baseline and no use of rescue antiemetic medication during or after radiotherapy.~Uncontrolled: Increase of three or more emetic episodes or use of antiemetic rescue medication."|Day 0 - Day 10|"The results here encompass the primary outcome measure the proportion of patients with complete prophylaxis and partial control, which is repeated in the secondary outcome. The secondary outcome Time to nausea, vomiting and/or use of rescue medication is unavailable due to the data not being collected/analysed."|||Participants|||Count of Participants
2614978|NCT02005887|Secondary|Patient-reported Symptoms (PRS) Outcomes|The patient-reported symptoms (PRS) will be assessed using the Functional Assessment of Cancer Therapy Endocrine Subscale (FACT-ES) comprising 18 items (each has score range from 0 to 4) with a possible minimum total score of 0 and maximum total score of 72 (72 is best). Functional Assessment of Chronic Illness Therapy (FACIT) guidelines will be used for scoring and interpretation of the FACT-ES total score.|At baseline, day 1 of cycle 2 and cycle 4 and prior to surgery; cycle 4 reported|All patients who received at least one dose of trial treatment and had at least one FACT-ES assessment were included in the analysis|||units on a scale||90% Confidence Interval|Number
2614979|NCT02005887|Secondary|Percentage of Patients Who Underwent Breast-Conserving Surgery (BCS)|Whether or not patient undergoes BCS (per Surgery form).|During surgery, an average of 2 hours|Two patients who did not have surgery were not evaluated|||percentage of patients||90% Confidence Interval|Number
2614980|NCT02005887|Secondary|Percentage of Patients With Node-negative Disease at Surgery|The number of lymph nodes assessed at surgery minus the number of positives nodes identified, equal to zero.|During surgery, an average of 2 hours|Two patients who did not have surgery were not evaluated|||percentage of patients||90% Confidence Interval|Number
2614981|NCT02005887|Secondary|Best Overall (Disease) Response|Based on WHO tumor measurement and response criteria [1], measured from the start of treatment across all time points until disease progression or the end of 6 cycles of neoadjuvant therapies, whichever comes first. Response was determined by the IBCSG Head of Medical Affairs. An internal review (IR) form was created to record the final determination on best overall response. Confirmation of partial or complete response by an additional scan was not required in this trial. Best overall response was assessed based on changes in tumor size from baseline to the assessments after 3 and after 6 cycles (denoted as day 1 of cycle 4 and prior to surgery respectively) as measured physically by caliper or ruler and as measured by breast tumor imaging (i.e., bilateral mammography and breast ultrasound).|From day 1 of cycle 1 across all time points until disease progression||||percentage of patients||90% Confidence Interval|Number
2614982|NCT02005887|Secondary|Preoperative Endocrine Prognostic Index (PEPI) Score|Preoperative Endocrine Prognostic Index (PEPI) is the sum of the risk points (tumor size, nodal status, Ki67 level, ER status) with a 0-12 score representing the best prognostic feature (0 being the best score; 12 being the worst score), as previously determined to be associated with recurrence-free survival.|After 24 weeks or the time of surgery|Two patients who did not have surgery were not evaluated|||scores on a scale||Inter-Quartile Range|Median
2614983|NCT02005887|Secondary|Ki67 Proliferation Marker Changes|The percent change in Ki67 expression from pre-treatment diagnostic (baseline) biopsy to surgery, calculated as (surgery-baseline)/baseline*100.|Before day1 of cycle 1 and surgery|Four patients are not evaluable: two patients did not undergo surgery during trial period, two patients did not have specimen submitted from surgery|||percentage change||Inter-Quartile Range|Median
2614984|NCT02005887|Primary|Time to Optimal Ovarian Function Suppression|Time from the first injection of degarelix or triptorelin to the first assessment of centrally assessed 17-β-estradiol (E2) level in the range of optimal ovarian function suppression (≤2.72 pg/mL or ≤10 pmol/L) during the 6 cycles of neoadjuvant treatments.|up to 24 weeks||||days||95% Confidence Interval|Median
2614985|NCT02005692|Primary|Turn Protocol Compliance|The primary clinical efficacy endpoint is to assess the change in turning protocol compliance after implementation of the DynaSense system.|Subjects will be followed for the length of hospital stay which is expected to average 5 days.||||percentage turn compliance||95% Confidence Interval|Number
2614986|NCT02005692|Primary|Safety Primary Endpoint|The safety primary endpoint is to assess safety by documenting the number, type, and severity of side effects and adverse events.|Subjects will be followed for the length of hospital stay which is expected to average 5 days, or until resolution of ADE.||||percentage of subjects with ADEs|||Number
2614987|NCT02005627|Secondary|End of Season Global Rhinitis Symptoms|Hayfever symptoms during last pollen season after start of treatment. Score on a scale ranges from minimum 0 point to maximum of 100 points. Higher score is more severe symptoms.|after treatment at 12 months||||score on a scale||Standard Error|Mean
2614988|NCT02005627|Secondary|Change From Baseline in Delta Peak Nasal Inspiratory Flow in L/Min|Nasal patency assessed at 60 minutes after nasal allergen challenge 12 months after treatment. The lower the peak nasal inspiratory flow the blockage nasal patency is.|60 minutes post-challenge after 12 months of treatment||||L/min||95% Confidence Interval|Mean
2614989|NCT02005627|Secondary|Late Phase Intradermal Test|Mean Diameter in millimetre of LPR skin responses to intradermal grass pollen allergen injection at 12 months in active versus placebo treated participants. The larger the diameter the worst symptoms|after 12 months of treatment||||millimeters||Standard Error|Mean
2614990|NCT02005627|Secondary|Early Phase Intradermal Test|Mean Diameter in millimetre of EPR skin responses to intradermal grass pollen allergen injection at 12 months in active versus placebo treated participants. The larger the diameter the worst symptoms.|after 12 months of treatment||||Millimiters||Standard Error|Mean
2614991|NCT02005627|Primary|Total Nasal Symptom Score After Nasal Allergen Challenge (NAC)|The total nasal symptom score at one hour after grass pollen nasal allergen challenge in active versus placebo treated participants after treatment period. Score ranges from minimum 0 point to maximum of 12 points. Higher score is more severe symptoms.|60 minutes post-challenge after 12 months of treatment||||score on a scale||95% Confidence Interval|Mean
2615000|NCT02005562|Secondary|Percentage of Participants With at Least One BPAR at Week 12 and Week 52|BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Weeks 12 and 52|ITT population; only participants with at least one assessed biopsy were included in the analysis.|||percentage of participants|||Number
2615001|NCT02005562|Secondary|Time to Occurrence of First BPAR Between Day 0 and Week 52|BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection at Week 12 was included in the analysis. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10% compared to BL values and BPAR of Grade ≥1 according to Banff 1997 classification at Week 12. The occurrence of the first BPAR was defined as the time from randomization to the first recorded BPAR between Day 0 and Week 52. The results of protocol biopsies at Week 12 were taken into account. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population|||days||95% Confidence Interval|Median
2615002|NCT02005562|Secondary|Time to Occurrence of First BPAR Between Day 0 and Week 52 - Percentage of Participants With an Event|BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection at Week 12 was included in the analysis. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10% compared to BL values and BPAR of Grade ≥1 according to Banff 1997 classification at Week 12. The occurrence of the first BPAR was defined as the time from randomization to the first recorded BPAR between Day 0 and Week 52. The results of protocol biopsies at Week 12 were taken into account. Participants were censored at the date of last treatment, date of last contact or withdrawal, and date of death.|Day 0, Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population|||percentage of participants|||Number
2615003|NCT02005562|Secondary|Creatinine Clearance Values Estimated With the Modification of Diet in Renal Disease (MDRD) Simplified Equation|The mean creatinine clearance values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52 estimated using the MDRD simplified equation. For males, the MDRD simplified equation was defined as MDRD (mL/min/1.73 square meters [m^2]) =186 multiplied by (*) serum creatinine in mg/L raised to the power of (^) -1.154 * age ^ -0.203. For females, the MDRD simplified equation was defined as MDRD (mL/min/1.73 m^2) = males formula * 0.742.|Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mL/min/1.73 m^2||Standard Deviation|Mean
2615004|NCT02005562|Secondary|Creatinine Clearance Values Estimated With the Cockcroft-Gault Equation (Milliliters Per Minute [mL/Min])|The mean creatinine clearance values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52 estimated using the Cockcroft-Gault equation.|Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||mL/min||Standard Deviation|Mean
2615005|NCT02005562|Secondary|Serum Creatinine Values [Micromoles Per Liter (µmol/L)]|The mean serum creatinine values at Weeks 2, 4, 6, 12, 16, 26, 39, and 52.|Weeks 2, 4, 6, 12, 16, 26, 39, and 52|ITT population; number (n) = number of participants assessed for the specified parameter at a given visit.|||µmol/L||Standard Deviation|Mean
2615006|NCT02005562|Primary|Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) Before Week 12 or Acute Subclinical Rejection on Protocol Biopsy at Week 12|BPAR was defined as the presence of clinical signs and kidney biopsy that confirmed the rejection before Week 12. Subclinical acute rejection was defined as an increase of serum creatinine at Week 12 strictly less than 10 percent (%) compared to baseline (BL) values and BPAR of Grade greater than or equal to (≥) 1 according to Banff 1997 classification at Week 12.|Week 12|ITT population; only participants with available protocol biopsy at Week 12 and/or a BPAR before Week 12 were included in the analysis.|||percentage of participants|||Number
2615007|NCT02005549|Secondary|Percentage of Participants Undergoing Breast-Conserving Surgery|Percentage of participants undergoing a breast-conserving procedure versus a modified radical mastectomy at final surgery, performed 2 to 4 weeks after the last chemotherapy cycle (Week 18)|20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])|ITT population.|||percentage of participants||95% Confidence Interval|Number
2615008|NCT02005549|Secondary|Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR)|Percentage of participants with pCR plus the percentage of participants without pCR who achieved CR or PR as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<] 10 millimeters [mm]). No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])|ITT population; participants evaluable for response included those participants who received a minimum of 3 cycles of treatment (9 weeks on study) with final surgery performed and the samples and reports available.|||percentage of participants||95% Confidence Interval|Number
2615009|NCT02005549|Primary|Percentage of Participants With Pathological Complete Response (pCR)|pCR was defined as the absence of signs for invasive tumor in the final surgical sample as judged by the local pathologist. Surgery was performed 2 to 4 weeks after the last chemotherapy cycle.|Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])|ITT population; participants evaluable for response included those participants who received a minimum of 3 cycles of treatment (9 weeks on study) with final surgery performed and the samples and reports available.|||percentage of participants||95% Confidence Interval|Number
2615010|NCT02005536|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Booster Vaccination With IMOVAX POLIO®|Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia. Grade 3 was defined as incapacitating, unable to perform usual activities for Pain; diameter ≥ 50 mm for Erythema and Swelling; Temperature ≥ 39.0°C for Fever; and significant, prevents daily activity for Headache, Malaise, and Myalgia.|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in all participants who received study vaccine (Safety Analysis Set).|||Number of participants|||Number
2615011|NCT02005536|Secondary|Geometric Mean of Individual Titer Ratios of Vaccine Antigens Following Booster Vaccination With IMOVAX POLIO®|Anti-polio virus anti-bodies were assessed by virus neutralization assay. The geometric mean titer ratio is the post-booster to pre-booster geometric mean ratio values.|Day 28 post-booster vaccination|Geometric mean of individual titer ratios were assessed in the per-protocol analysis set.|||Titer Ratio||95% Confidence Interval|Geometric Mean
2615012|NCT02005536|Secondary|Percentage of Participants With Seroprotection Against Polio Antigens Before and After Booster Vaccination With IMOVAX POLIO®|Seroprotection was defined as a titer of ≥ 8 (1/dil) pre-booster or post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay|Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination|Anti-polio booster response was assessed in the per-protocol analysis set.|||Percentage of participants|||Number
2615013|NCT02005536|Secondary|Geometric Mean Titers of Vaccine Antigens Before and After Vaccination With IMOVAX POLIO®|Anti-polio virus antibodies were assessed by virus neutralization assay.|Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination|Geometric mean titers was assessed in the per-protocol analysis set.|||Titers||95% Confidence Interval|Geometric Mean
2615014|NCT02005536|Primary|Percentage of Participants With Booster Responses Against Polio Antigens Following Vaccination With IMOVAX POLIO®|A booster response was defined as a 4-fold increase from pre-booster to post-booster vaccination. Anti-polio virus antibodies were assessed by virus neutralization assay.|Day 28 post-vaccination|Anti-polio booster response was assessed in the per-protocol analysis set.|||Percentage of participants|||Number
2615015|NCT02005484|Secondary|Time to Progression|Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause. If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.|Weekly throughout the study|ITT population|||months||Full Range|Median
2615016|NCT02005484|Secondary|Time to Progression - Number of Participants With an Event|Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause. If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.|Weekly throughout the study|ITT population|||participants|||Number
2615017|NCT02005484|Secondary|Overall Survival|Overall survival (OS) was defined as the time, in months, from the date of study entry to the date of the death due to any cause. If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.|Weekly throughout the study|ITT population|||months||Full Range|Median
2615018|NCT02005484|Secondary|Overall Survival - Number of Participants Who Died|OS was defined as the time, in months, from the date of study entry to the date of the death due to any cause. If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.|Weekly throughout the study|ITT population|||participants|||Number
2615019|NCT02005484|Secondary|Percentage of Participants With a Best Overall Response of CR or PR|Tumor response assessed according to RECIST. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: ≥30% decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.|Weekly throughout the study|ITT population|||percentage participants|||Number
2615020|NCT02005484|Secondary|Percentage of Participants With Clinical Benefit|Participants were classified as having a clinical benefit if they had a best overall tumor response of CR, PR, or SD. Tumor response assessed according to RECIST. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: ≥30% decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. Stable SD: not qualifying for CR, PR, or PD.|Weekly throughout the study|ITT population|||percentage participants|||Number
2615021|NCT02005484|Primary|Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category|Tumor response assessed according to RECIST. Complete response (CR): complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<]10 millimeters [mm]); no new lesions. Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. Stable disease (SD): not qualifying for CR, PR, or progressive disease (PD). Participants who could not be classified per RECIST were allocated as follows: early death from malignant disease (death due to cancer), early death because of other cause (death not related to toxicity or cancer disease), and unknown (for not fitting into the above categories).|Weekly throughout study|ITT population|||percentage of participants|||Number
2615022|NCT02005471|Post-Hoc|Euro QoL 5 Dimension (EQ-5D) Questionnaire Score||Baseline, D1 of Cycles 1, 2, 3, 4, 5, 6, STC/EW visit (up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days||2023-06-30|06/2023||||
2615050|NCT02005393|Primary|Image Quality Scores Using Likert Scale|"Likert score ratings of image quality for FICE and NBI images. Each FICE setting was compared to NBI, to determine which FICE settings were equivalent to NBI.~Likert Scores:~Not seen;~poor but usable, characteristic features are detectable but details are not fully reproduced; features just visible;~good; allows an adequate assessment, details of anatomical structures are visible but not necessarily clearly defined; details emerging;~very good; allows an excellent assesssment, anatomical details are clearly defined; details clear"|One day|All patients had imaging done with both FICE, immediately followed by NBI. Images for one subject were not included in the Reader Study due to an error on the Compact Flash card which resulted in three (3) corrupt FICE images (FICE settings 0, 1 & 2); therefore making 19 out of 20 participants analyzed.|||units on a scale||Standard Deviation|Mean
2615023|NCT02005471|Secondary|Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score|The EORTC QLQ-CLL16 module is designed for participants with Stage 0 to Stage 4 CLL. It is composed of 16 questions and there are four multi-item scales on Fatigue (2 items), Treatment-related side effects (TRSE, 4 items), Disease-related symptoms (DRS, 4 items), and Infection (4 items); and two single-item scales on social activities and future health worries. Multi-item scales score are reported and the total score for each multi-item scale was transformed to result in a total score range of 0 to 100, where higher score = poor HRQoL.|Baseline, D1 of Cycles 1, 2, 3, 4, 5, 6, STC/EW visit (up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days|Analysis was performed on PRO-evaluable population. Here, 'Overall Number of Participants Analyzed’ signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time point.|||units on a scale||Standard Deviation|Mean
2615024|NCT02005471|Secondary|Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score|The EORTC QLQ-C30 is a validated self-report measure consisting of 30 questions incorporated into five functional scales (Physical, Role, Cognitive, Emotional, and Social scales), three symptom scales (fatigue, pain, nausea, and vomiting scales), a global health status/global QoL scale, and single items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea). Most questions used 4-point scale (1='Not at all' to 4='Very much'), while 2 questions used 7-point scale (1='very poor' to 7='Excellent'). Functional scales score and global health status/global QoL scale score are reported. Scores were averaged, transformed to 0-100 scale; where higher score for functional scales = poor level of functioning and higher score for global health status/global QoL = better HRQoL.|Baseline, D1 of Cycles 1, 2, 3, 4, 5, 6, STC/EW visit (up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days|Analysis was performed on PRO-evaluable population. Here, 'Overall Number of Participants Analyzed’ signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time point.|||units on a scale||Standard Deviation|Mean
2615025|NCT02005471|Secondary|Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores|MDASI is a 25-item validated questionnaire consisting of 2 parts. Part 1: 19-items divided into 2 scales, Core Symptom Severity (average of Questions 1 to 13; total 13 items: pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness) and Module Symptom Severity (average of Questions 14 to 19; total 6 items: night sweats, fevers and chills, lymph node swelling, diarrhea, bruising easy or bleeding, and constipation). Part 2: 6-items to assess Interference (symptom distress) (average of Questions 20 to 25; total 6 items: general activity, walking, work, mood, relations with other people, and enjoyment of life). Each item was rated from 0 to 10, with lower scores indicating better outcome. Total score for Core Symptom Severity, Module Symptom Severity, and Interference are reported which range from 0 to 10, with lower scores indicating better health-related quality of life (HRQoL).|Baseline, Days 1, 8, and 15 of Cycles 1, 2, and 3; Cycle length = 28 days|Analysis was performed on patient reported outcome (PRO)-evaluable population, which included all participants with baseline and at least one post-baseline PRO assessment. Here, 'Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable at specified time point.|||units on a scale||Standard Deviation|Mean
2615026|NCT02005471|Secondary|Change From Baseline in Lymphocyte Subset Counts at Specified Time Points||Baseline, C4D14-28, Study Treatment Completion/Early Withdrawal (STC/EW, up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and at FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days||2023-06-30|06/2023||||
2615027|NCT02005471|Secondary|Plasma Venetoclax Concentrations||Pre-dose (0 hour, anytime before venetoclax administeration) and 4 hours post-dose on D1 of Cycles 1 and 4; Cycle length = 28 days|Analysis was performed on Pharmacokinetic (PK)-Evaluable population, which included all participants in the ‘Venetoclax + Rituximab’ arm and who received at least one dose of venetoclax with at least one post-dose PK concentration result available. Here 'Number Analyzed' signifies the number of participants evaluable at specified time point.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
2615028|NCT02005471|Secondary|Percentage of Participants With Minimal Residual Disease (MRD) Negativity at the EoCTR Visit|MRD-negativity was defined as the presence of <1 malignant B-cell per 10000 normal B-cells in a sample of at least 200000 B-cells, as assessed by the allele specific oligonucleotide polymerase chain reaction (ASO-PCR) and/or flow cytometry technique. Percentage of participants with MRD-negativity at the EoCTR visit was reported. The 95% CI was computed using Pearson-Clopper method.|EoCTR visit (8 to 12 weeks after C6D1); Cycle length = 28 days|Analysis was performed on ITT population.|||percentage of participants||95% Confidence Interval|Number
2615029|NCT02005471|Secondary|Time to New Anti-CLL Treatment (TTNT) as Assessed by the Investigator|TTNT was defined as the time from randomization until start of new non-protocol-specified anti-CLL treatment or death from any cause. Participants without the event at the time of analysis were censored at the last visit date for this outcome measure analysis. The median TTNT was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley.|Baseline up to start of new ani-CLL therapy or death, whichever occurred first (up to approximately 3 years)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
2615030|NCT02005471|Secondary|Percentage of Participants With Start of New Anti-CLL Treatment or Death as Assessed by the Investigator|Percentage of participants with start of new non-protocol-specified anti-CLL therapy, as assessed by the investigator, or death from any cause, during the study, was reported.|Baseline up to start of new ani-CLL therapy or death, whichever occurred first (up to approximately 3 years)|Analysis was performed on ITT population.|||percentage of participants|||Number
2615163|NCT02004093|Primary|Kaplan-Meier Probability of No Disease or Progression at 1 Year|The probability of being event free (no disease progression or death events) at 1 year in participants remaining at risk.|1 year|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 17 and 12 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.|||percent|||Number
2615031|NCT02005471|Secondary|Duration of Responses (DOR) as Assessed by the Investigator Using iwCLL Guidelines|DOR was defined as the time from first occurrence of a documented response of CR, CRi, nPR, or PR until PD/relapse, as assessed by the investigator according to the iwCLL guidelines, or death from any cause. PD: occurrence of one of the following: new lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; increase of >/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count >/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of >/=50% in platelet or neutrophil count, or hemoglobin level by >2 g/dL or to <10 g/dL. Participants without PD or death after response were censored at the last date of adequate response assessment. The median DOR was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. CR, CRi, nPR, and PR have been defined in previous outcomes, and are not repeated here due to space constraint.|From time of achieving best overall response until PD or death from any cause, whichever occurred first (up to approximately 3 years)|Analysis was performed on ITT population participants who had best overall response of CR, CRi, nPR, or PR.|||months||95% Confidence Interval|Median
2615032|NCT02005471|Secondary|Percentage of Participants With PD or Death Among Participants With Best Overall Response of CR, CRi, nPR, or PR as Assessed by the Investigator Using iwCLL Guidelines|Percentage of participants with PD as assessed by the investigator according to the iwCLL guidelines or death from any cause during the study was reported. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; an increase of >/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count >/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of >/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by >2 g/dL or to <10 g/dL. CR, CRi, nPR, and PR have been defined in previous outcomes, and are not repeated here due to space constraint.|From time of achieving best overall response until PD or death from any cause, whichever occurred first (up to approximately 3 years)|Analysis was performed on ITT population participants who had best overall response of CR, CRi, nPR, or PR.|||percentage of participants|||Number
2615033|NCT02005471|Secondary|Event-Free Survival (EFS) as Assessed by the Investigator Using iwCLL Guidelines|EFS was defined as the time from date of randomization until the date of PD/relapse, start of a new non-protocol-specified anti-CLL therapy, or death from any cause, whichever occurred first, as assessed by the investigator. PD: occurrence of one of the following: new lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; increase of >/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count >/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of >/=50% in platelet or neutrophil count, or hemoglobin level by >2 g/dL or to <10 g/dL. Participants without any of the specified event at the time of analysis were censored at the date of last adequate response assessment. In case of no post-baseline response assessment, participants were censored at the randomization date. The median EFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley.|Baseline up to PD/relapse, start of a new anti-CLL therapy, or death from any cause, whichever occurred first (maximum up to Data Cut-off date, overall approximately 3 years)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
2615034|NCT02005471|Secondary|Percentage of Participants With PD/Relapse, Start of a New Anti-Chronic Lymphocytic Leukemia (CLL) Therapy, or Death as Assessed by the Investigator Using iwCLL Guidelines|Percentage of participants with PD/relapse, death from any cause, or start of a new non-protocol-specified anti-CLL therapy as assessed by the investigator, during the study, was reported. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; an increase of >/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count >/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of >/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by >2 g/dL or to <10 g/dL.|Baseline up to PD/relapse, start of a new anti-CLL therapy, or death from any cause, whichever occurred first (maximum up to Data Cut-off date, overall approximately 3 years)|Analysis was performed on ITT population.|||percentage of participants|||Number
2615035|NCT02005471|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause. Participants alive at the time of the analysis were censored at the date when they were last known to be alive as documented by the investigator. The median OS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley.|Baseline up to last FUV (maximum up to Data Cut-off date, overall approximately 3 years)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
2615036|NCT02005471|Secondary|Percentage of Participants Who Died|Percentage of participants who died from any cause, during the study, was reported.|Baseline up to last FUV (maximum up to Data Cut-off date, overall approximately 3 years)|Analysis was performed on ITT population.|||percentage of participants|||Number
2615037|NCT02005471|Secondary|Percentage of Participants With Overall Response of CR, Cri, nPR, or PR at End of Combination Treatment Visit as Assessed by the IRC Using iwCLL Guidelines|Response was assessed by the IRC according to the iwCLL guidelines and was confirmed by repeat assessment >/=4 weeks after initial documentation. CR: peripheral blood lymphocytes <4000/mcL; absence of any new lesion, nodal disease, lymphadenopathy, hepatomegaly, splenomegaly, and constitutional symptoms; neutrophils >1500/mcL, platelets >100000/mcL, hemoglobin >11.0 g/dL without need for transfusion or exogenous growth factors; normocellular bone marrow with <30% lymphocytes; no lymphoid nodules. CRi: fulfilling all CR criteria but persistent cytopenia. PR: >/=50% reduction in two of the following: peripheral blood lymphocytes, lymphadenopathy, spleen and/or liver enlargement; and one of the following: neutrophils >1500/mcL, platelets >100000/mcL, hemoglobin >11.0 g/dL or >/=50% improvement without need for transfusion or exogenous growth factors. nPR: fulfilling all CR criteria but presence of lymphoid nodules. The 95% CI was computed using Pearson-Clopper method.|EoCTR visit (8 to 12 weeks after C6D1); Cycle length = 28 days|Analysis was performed on ITT population. Participants without post-baseline response assessment were considered as non-responders.|||percentage of participants||95% Confidence Interval|Number
2615745|NCT01997437|Secondary|Number of Survival Patients|To evaluate the survival of patient after transplantation of stem-cell seeded bioartificial trachea during 12 months post operative follow up.|12 months post operative follow up||||participants|||Number
2615038|NCT02005471|Secondary|Percentage of Participants With Overall Response of CR, Cri, nPR, or PR at End of Combination Treatment Visit as Assessed by the Investigator Using iwCLL Guidelines|Response was assessed by the investigator according to the iwCLL guidelines and was confirmed by repeat assessment >/=4 weeks after initial documentation. CR: peripheral blood lymphocytes <4000/mcL; absence of any new lesion, nodal disease, lymphadenopathy, hepatomegaly, splenomegaly, and constitutional symptoms; neutrophils >1500/mcL, platelets >100000/mcL, hemoglobin >11.0 g/dL without need for transfusion or exogenous growth factors; normocellular bone marrow with <30% lymphocytes; no lymphoid nodules. CRi: fulfilling all CR criteria but persistent cytopenia. PR: >/=50% reduction in two of the following: peripheral blood lymphocytes, lymphadenopathy, spleen and/or liver enlargement; and one of the following: neutrophils >1500/mcL, platelets >100000/mcL, hemoglobin >11.0 g/dL or >/=50% improvement without need for transfusion or exogenous growth factors. nPR: fulfilling all CR criteria but presence of lymphoid nodules. The 95% CI was computed using Pearson-Clopper method.|End of combination treatment response (EoCTR) visit (8 to 12 weeks after Cycle [C] 6 Day [1]); Cycle length = 28 days|Analysis was performed on ITT population. Participants without post-baseline response assessment were considered as non-responders.|||percentage of participants||95% Confidence Interval|Number
2615039|NCT02005471|Secondary|Percentage of Participants With Best Overall Response of CR, CRi, nPR, or PR as Assessed by the IRC Using iwCLL Guidelines|Response was assessed by the IRC according to the iwCLL guidelines and was confirmed by repeat assessment >/=4 weeks after initial documentation. CR: peripheral blood lymphocytes <4000/mcL; absence of any new lesion, nodal disease, lymphadenopathy, hepatomegaly, splenomegaly, and constitutional symptoms; neutrophils >1500/mcL, platelets >100000/mcL, hemoglobin >11.0 g/dL without need for transfusion or exogenous growth factors; normocellular bone marrow with <30% lymphocytes; no lymphoid nodules. CRi: fulfilling all CR criteria but persistent cytopenia. PR: >/=50% reduction in two of the following: peripheral blood lymphocytes, lymphadenopathy, spleen and/or liver enlargement; and one of the following: neutrophils >1500/mcL, platelets >100000/mcL, hemoglobin >11.0 g/dL or >/=50% improvement without need for transfusion or exogenous growth factors. nPR: fulfilling all CR criteria but presence of lymphoid nodules. The 95% CI was computed using Pearson-Clopper method.|Baseline up to last FUV (maximum up to data cut-off date, overall approximately 3 years)|Analysis was performed on ITT population. Participants without post-baseline response assessment were considered as non-responders.|||percentage of participants||95% Confidence Interval|Number
2615040|NCT02005471|Secondary|Percentage of Participants With Best Overall Response of Complete Response (CR), CR With Incomplete Bone Marrow Recovery (CRi), Nodular Partial Response (nPR), or Partial Response (PR) as Assessed by the Investigator Using iwCLL Guidelines|Response was assessed by the investigator according to the iwCLL guidelines and was confirmed by repeat assessment >/=4 weeks after initial documentation. CR: peripheral blood lymphocytes <4000/mcL; absence of any new lesion, nodal disease, lymphadenopathy, hepatomegaly, splenomegaly, and constitutional symptoms; neutrophils >1500/mcL, platelets >100000/mcL, hemoglobin >11.0 g/dL without need for transfusion or exogenous growth factors; normocellular bone marrow with <30% lymphocytes; no lymphoid nodules. CRi: fulfilling all CR criteria but persistent cytopenia. PR: >/=50% reduction in two of the following: peripheral blood lymphocytes, lymphadenopathy, spleen and/or liver enlargement; and one of the following: neutrophils >1500/mcL, platelets >100000/mcL, hemoglobin >11.0 g/dL or >/=50% improvement without need for transfusion or exogenous growth factors. nPR: fulfilling all CR criteria but presence of lymphoid nodules. The 95% CI was computed using Pearson-Clopper method.|Baseline up to last follow-up visit (FUV) (maximum up to data cut-off date, overall approximately 3 years)|Analysis was performed on ITT population. Participants without post-baseline response assessment were considered as non-responders.|||percentage of participants||95% Confidence Interval|Number
2615041|NCT02005471|Secondary|PFS as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test|PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the IRC using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; increase of >/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count >/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of >/=50% in platelet or neutrophil count, or hemoglobin level by >2 g/dL or to <10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley.|Baseline up to PD or death, whichever occurred first (up to approximately 3 years)|Analysis was performed on ITT population participants with 17p deletion as identified by FISH test.|||months||95% Confidence Interval|Median
2615042|NCT02005471|Secondary|Percentage of Participants With PD or Death as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test|Assessment of response was performed by the IRC according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; an increase of >/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count >/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of >/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by >2 g/dL or to <10 g/dL.|Baseline up to PD or death, whichever occurred first (up to approximately 3 years)|Analysis was performed on ITT population participants with 17p deletion as identified by FISH test.|||percentage of participants|||Number
2615051|NCT02005354|Primary|Perception of Pain Will be Measured Using a Validated Numerical 0-10 Pain Scale Where 0 = no Pain and 10 = Worst Possible Pain|"To establish the effect of high-frequency stimulation TENS on the pain experienced by patients undergoing a bone-marrow biopsy, using standard technique with local anaesthetic.~The perception of pain will be measured using a pain scale directly after and 24 hours after bone-marrow sampling in patients randomly allocated and blinded to the use of intervention-TENS (IT) or control-TENS (CT) in addition to local anaesthesia."|Post procedure and 24 hours||||Numerical Pain Severity Scale (0-10)||95% Confidence Interval|Mean
2615052|NCT02005276|Secondary|Average Number of Steps Per Day During Intervention|Secondary outcomes include average number of steps per day during intervention (with incentives) and follow up periods (without incentives).|End of study- 6 months after enrollment||||steps per day||95% Confidence Interval|Mean
2615043|NCT02005471|Secondary|PFS as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test|PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the investigator using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; increase of >/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count >/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of >/=50% in platelet or neutrophil count, or hemoglobin level by >2 g/dL or to <10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley.|Baseline up to PD or death, whichever occurred first (up to approximately 3 years)|Analysis was performed on ITT population participants with 17p deletion as identified by FISH test.|||months||95% Confidence Interval|Median
2615044|NCT02005471|Secondary|Percentage of Participants With PD or Death as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by Fluorescence In-situ Hybridization (FISH) Test|Assessment of response was performed by the investigator according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; an increase of >/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count >/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of >/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by >2 g/dL or to <10 g/dL.|Baseline up to PD or death, whichever occurred first (up to approximately 3 years)|Analysis was performed on ITT population participants with 17p deletion as identified by FISH test.|||percentage of participants|||Number
2615045|NCT02005471|Secondary|PFS as Assessed by the IRC Using Standard iwCLL Guidelines|PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the IRC using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; increase of >/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count >/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of >/=50% in platelet or neutrophil count, or hemoglobin level by >2 g/dL or to <10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley.|Baseline up to PD or death, whichever occurred first (up to approximately 3 years)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
2615046|NCT02005471|Secondary|Percentage of Participants With PD or Death as Assessed by the Independent Review Committee (IRC) Using Standard iwCLL Guidelines|Assessment of response was performed by the IRC according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; an increase of >/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count >/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of >/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by >2 g/dL or to <10 g/dL.|Baseline up to PD or death, whichever occurred first (up to approximately 3 years)|Analysis was performed on ITT population.|||percentage of participants|||Number
2615047|NCT02005471|Primary|Progression-Free Survival (PFS) as Assessed by the Investigator Using Standard iwCLL Guidelines|PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the investigator using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; increase of >/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count >/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of >/=50% in platelet or neutrophil count, or hemoglobin level by >2 g/dL or to <10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% confidence interval (CI) was computed using method of Brookmeyer and Crowley.|Baseline up to PD or death, whichever occurred first (up to approximately 3 years)|Analysis was performed on ITT population.|||months||95% Confidence Interval|Median
2615048|NCT02005471|Primary|Percentage of Participants With PD as Assessed by the Investigator Using Standard International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines or Death|Assessment of response was performed by the investigator according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (greater than [>] 1.5 centimeters [cm]); unequivocal progression of non-target lesion; an increase of greater than or equal to (>/=) 50 percent (%) compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count >/=5000 per microliter (mcL), or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of >/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by >2 grams per deciliter (g/dL) or to less than [<] 10 g/dL.|Baseline up to PD or death from any cause, whichever occurred first (up to approximately 3 years)|Analysis was performed on ITT population.|||percentage of participants|||Number
2615049|NCT02005445|Primary|WHO Disability Assessment Scale 2 Scores|Functional status as measured by the World Health Organization Disability Assessment Scale 2.0. Score range 0-48 (higher scores indicate more disability).|12 weeks|As we were unable to recruit a sufficient number of patients for meaningful analysis, due to closing of the cardiac Rehabilitation program, no analysis was performed. Because there were only 1-2 participants completing the study in each arm, data are not presented due too confidentiality concerns.||||||
2615123|NCT02004366|Secondary|Subjects With Wound and Other Infections|Subjects with wound and other infections.|During Hospitalization and outpatient up to 12 weeks||||Participants|||Count of Participants
2615053|NCT02005276|Primary|Proportion of Days a Minimum Activity of 7000 Steps or More is Achieved During Intervention|Our primary outcome measure is the proportion of days a minimum activity of 7000 steps or more is achieved. We will assess outcomes for 3 months using incentives followed by 3 months of follow-up without incentives. All available data will be analyzed, and missing will be treated as true missing data points. Secondary outcomes will include the average steps walked per day.|End of study- 6 months of after enrollment||||Proportion of participant days||95% Confidence Interval|Mean
2615054|NCT02005250|Primary|Thyroid Extreme CT|Bone cortical thickness in the radius measured by high-resolution peripheral quantitative CT, in newly diagnosed thyroid disorder, before and after treatment aimed to obtain euthyroidism|one year||||mm||Inter-Quartile Range|Median
2615055|NCT02005211|Primary|Safety - Adverse Events|Safety - Number of subjects reporting any adverse events during the study|Day of first dose to follow up|Safety|||Participants|||Number
2615056|NCT02005211|Secondary|Biomarker|Biomarker (Abeta 1-40; A beta 1-42) % change from baseline|Pre dose vs Day 14|Pharmacodynamic|||% change from baseline||Standard Deviation|Mean
2615057|NCT02005211|Secondary|PK AUC - Overall Study (SAD & MAD Parts)|Pharmacokintic Area Under the Curve (0 to t)|0,0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr|healthy Japanese participants|||hr.ng/mL||Geometric Coefficient of Variation|Geometric Mean
2615058|NCT02005211|Secondary|PK Cmax - Overall Study|Pharmacokinetic maximum concentration|0, 0.5,1,2,3,4,8,12,24,48 hr single dose, multiple dose does not include 48 hr|Pharmacokinetic|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2615059|NCT02005029|Secondary|Mean Cmax of Plasma Levodopa After Erythromycin Versus Placebo|Mean Cmax of plasma levodopa after erythromycin versus placebo. Plasma samples were collected at the following times post-levodopa dose: 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, and 240 minutes.|2 weeks, between visits 2 and 3|Of the original ten participants; one participant's data was excluded due to symptomatic orthostasis which likely confounded her results, one participant was withdrawn early due to noncompliance, and one participant had undetectable plasma levodopa levels throughout the study and was thus excluded from the pharmacokinetic analysis.|||ng/mL||Standard Deviation|Mean
2615060|NCT02005029|Secondary|MDS-UPDRS Part 3 (Movement Disorders Society- Unified Parkinson's Disease Rating Scale)|Part 3 of this scale is a standardized physical assessment that quantifies the total burden of motor symptoms in Parkinson's disease patients. Each of the 18 items on the scale is rated from 0 (none, 1 (slight), 2 (mild), 3 (moderate) and 4 (severe). Scores range from 0-72. Higher scores represent a more severe burden of motor symptoms (a worse outcome).|2 weeks, between visits 2 and 3|One participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.|||units on a scale||Standard Deviation|Mean
2615061|NCT02005029|Secondary|Change in Dyskinesia|Mean total AIMS (Abnormal Involuntary Movements Scale) score after receiving erythromycin minus mean total AIMS score after receiving placebo. The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. Ten of the items are rated on a five-point scale of severity from 0-4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Two of the items are not scored. Total score range is from 0 to 40. Higher scores represent more severe dyskinesia (a worse outcome).|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.|||units on a scale||Standard Deviation|Mean
2615062|NCT02005029|Secondary|Timed up and go Test (TUAG) Fast Speed|Change in motor function as assessed by timed up and go test (fast speed). This test measures the total time to stand from a chair, walk 10 feet, and return to sitting.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.|||seconds||Standard Deviation|Mean
2615063|NCT02005029|Secondary|Timed up and go Test (TUAG) Comfortable Speed|Change in motor function as assessed by timed up and go test (comfortable speed). This test measures the total time to stand from a chair, walk 10 feet, and return to sitting.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.|||seconds||Standard Deviation|Mean
2615064|NCT02005029|Secondary|Comfortable 20 Feet Gait Speed (CGS)|Change in motor function as assessed by comfortable 20 feet gait speed (CGS)|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.|||seconds||Standard Deviation|Mean
2615065|NCT02005029|Secondary|Five Times Sit-to-stand Test|Change in motor function as measured by Five times sit-to-stand test. This test measures the total time to complete 5 repetitions of sit to stand.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.|||seconds||Standard Deviation|Mean
2615066|NCT02005029|Secondary|9-hole Peg Test Left Hand|Change in motor function as assessed by 9-hole peg test for upper extremity manipulation/dexterity. This test measures the total time required to place and remove 9 holes in a pegboard. Each hand is tested separately.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.|||seconds||Standard Deviation|Mean
2615067|NCT02005029|Secondary|9-hole Peg Test Right Hand|Change in motor function as assessed by 9-hole peg test for upper extremity manipulation/dexterity. This test measures the total time required to place and remove 9 holes in a pegboard. Each hand is tested separately.|2 weeks, between visits 2 and 3|Of the original 10 participants, one participant's data was excluded due to symptomatic orthostasis which likely confounded her results and one participant was withdrawn early due to noncompliance.|||seconds||Standard Deviation|Mean
2615124|NCT02004366|Secondary|Fasting BG Concentration|Average - per hospital stay - fasting BG concentration (for in-hospital groups), and average - per outpatient follow-up period - fasting BG concentration (for discharge groups)|During Hospitalization (average 5 days) and outpatient up to 12 weeks||||mg/dl||Standard Deviation|Mean
2615068|NCT02005029|Primary|Area Under the Curve 0-4 Hours for Plasma Levodopa After Erythromycin Versus Placebo|Mean Area under the Curve 0-4 hours for plasma levodopa after erythromycin versus placebo. Plasma samples were collected at the following times post-levodopa dose: 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, and 240 minutes.|2 weeks, between visits 2 and 3|Of the original ten participants; one participant's data was excluded due to symptomatic orthostasis which likely confounded her results, one participant was withdrawn early due to noncompliance, and one participant had undetectable plasma levodopa levels through out the study and was thus excluded from the pharmacokinetic analysis.|||ng/mL*min||Standard Deviation|Mean
2615069|NCT02005029|Primary|Gastric Emptying Time|Mean gastric emptying time in minutes as measured by SmartPill|2 weeks, between visits 2 and 3|Of the original ten participants; one participant's data was excluded due to symptomatic orthostasis which likely confounded her results, one participant was withdrawn early due to noncompliance, and four participants were unable to complete a SmartPill evaluation.|||minutes||Standard Deviation|Mean
2615070|NCT02005016|Secondary|Change From Baseline on Comprehensive Aphasia Test Modality Mean T-Score|The Comprehensive Aphasia Test (CAT) is a performance-based measure of language processing across multiple language domains commonly used to assess language-processing ability among adults with aphasia. The CAT Modality Mean T-Score represents an measurement of overall language-processing ability (aphasia severity). Scores are on a T-score scale (mean score 50, 2 SD range from 30 to 70), with higher scores representing better performance. Change in CAT score from entry to exit (secondary outcome) measures treatment-related changes in overall aphasia severity.|Baseline (at study entry) to the day after completion of intervention (after 4 weeks of behavioral therapy).||||units on a scale||Standard Error|Mean
2615071|NCT02005016|Primary|Change From Baseline in Philadelphia Naming Test Score|The Philadelphia Naming Test is a performance-based measure commonly used to assess naming (word production) ability among adults with aphasia. Participants are shown 175 pictures of common objects and asked to name each stimulus item within 30 seconds. Score range is from 0 to 175 (number out of 175 items that were correctly named), with higher scores representing better performance. Change in PNT score from entry to exit is the primary study outcome. Mean PNT change score measures treatment-related changes in naming ability.|Baseline (at study entry) to the day after completion of intervention (after 4 weeks of behavioral therapy).|The PNT was administered at two timepoints for the majority of the sample (32/44). The initial 12 participants received the PNT at study entry and abbreviated forms of the assessment during the protocol and at study exit. These abbreviated forms were found not to be reliable, so the full PNT was administered to remaining participants at exit.|||score on a scale||Standard Error|Mean
2615072|NCT02004990|Secondary|Dental Plaque Composition Measured by Numbers of Bacteria Present|Dental plaque is a multispecies bacterial biofilm and the specific bacteria populating this biofilm will be measured. Measurement will be change in thickness of the biofilm|2-4 weeks||||micrometers||Standard Deviation|Mean
2615073|NCT02004990|Primary|Dental Plaque Levels Measures on Scale of 0-2|Modified plaque index for the mixed dentition scale is 0-2 (0=best 2=worse)|2-4 weeks||||units on a scale||Standard Deviation|Mean
2615074|NCT02004977|Other Pre-specified|Social Support|Change in social support from baseline to SY2. Assessment of social support for breakfast was measured by asking the students to consider a typical month and record how often the following people encouraged them to eat or continue to eat breakfast at school: (1) parent/guardian, (2) friend, (3) other kids at my school, (4) teacher, and (5) other school staff. A 4-point Likert-type scale (disagree to agree, 0-4) for each of the categories was used. The total scale summed the five categories. The scale ranged from 0-20, a higher score indicates more social support.|Change in perceived support from baseline at the end of the school year (SY2)||||scores on a scale||Standard Deviation|Mean
2615075|NCT02004977|Other Pre-specified|Change From Baseline in Healthy Eating Index Scores|Change in the total Healthy Eating Index score from baseline to SY2. The Healthy Eating Index (HEI) score is a measure of diet quality. HEI scores can range from 0 to 100, with 0 representing the least overall healthy diet, and 100 representing the most overall healthy diet|Change from baseline in Healthy Eating Index at the end of the school year (SY2).|The number of participants does not match that the the flow chart, and we were not able to to get post (SY2) HEI measures in all of the enrolled students.|||Healthy Eating Index Total Score||Standard Deviation|Mean
2615076|NCT02004977|Secondary|Change From Baseline in Percent Body Fat|Student percent body fat will be measured by trained research staff|Change from baseline in student body fat at the end of the school year (SY2)|The number of participants does not match that the the flow chart, and we were not able to to get post (SY2) % body fat measures in all of the enrolled students.|||% Body Fat||Standard Deviation|Mean
2615077|NCT02004977|Secondary|Change From Baseline in Body Mass Index|Change from baseline to the end of one school year (SY2) in body mass index.|Change from baseline (SY1) in student body mass index at the end of one school year (SY2).|The number of participants does not match that the the flow chart, and we were not able to to get post (SY2) BMI measures in all of the enrolled students.|||kg/m^2||Standard Deviation|Mean
2615078|NCT02004977|Primary|Change From Baseline in Percent Students Eating the School Breakfast Per School|Change in participation in the reimbursable school breakfast program will be evaluated from school provided objective participation data from baseline (SY1) to the end of one school year (SY2)|Change from baseline (SY1) in average school year school-level breakfast participation at the end of one school year (SY2).||||% School Breakfast Participation|Schools|Standard Deviation|Mean
2615079|NCT02004886|Secondary|Change From Baseline in 3-hour Insulin Total AUC at Week 4|Blood samples were collected for insulin 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour Insulin Total AUC was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.|||µIU hr/mL||95% Confidence Interval|Least Squares Mean
2615125|NCT02004366|Secondary|Hospital Mortality|Hospital mortality (ONLY in-patient). Mortality is defined as death occurring during hospital stay.|During Hospitalization-average 5 days|Hospital mortality is applicable ONLY for inpatients arms (1 and 2)|||Participants|||Count of Participants
2615080|NCT02004886|Secondary|Change From Baseline in 3-hour AUC for C-peptide at Week 4|Blood samples were collected for C-peptide 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour AUC for C-peptide was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.|||ng hr/mL||95% Confidence Interval|Least Squares Mean
2615081|NCT02004886|Secondary|Change From Baseline in 3-hour Area Under the Plasma Concentration Versus Time Curve (AUC) for Glucose at Week 4|Blood samples collected for glucose 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour AUC for Glucose was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.|||mg hr/dL||95% Confidence Interval|Least Squares Mean
2615082|NCT02004886|Secondary|Change From Baseline in 2-hour Post-prandial Glucose Excursion at Week 4|2-hour post-prandial glucose excursion is the change in glucose concentration in the blood 2 hours after a meal. Change from baseline in 2-hour post-prandial glucose excursion at Week 4 is defined as Week 4 minus baseline.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.|||mg/dL||95% Confidence Interval|Least Squares Mean
2615083|NCT02004886|Secondary|Change From Baseline in Fasting Insulin at Week 4|Fasting insulin levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.|||μIU/mL||95% Confidence Interval|Least Squares Mean
2615084|NCT02004886|Secondary|Change From Baseline in Fasting C-peptide at Week 4|Fasting C-peptide levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.|||ng/mL||95% Confidence Interval|Least Squares Mean
2615085|NCT02004886|Secondary|Change From Baseline in Fructosamine at Week 4|Fructosamine levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.|||mg/dL||95% Confidence Interval|Least Squares Mean
2615086|NCT02004886|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Plasma Glucose levels were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.|||mg/dL||95% Confidence Interval|Least Squares Mean
2615087|NCT02004886|Primary|Number of Participants Discontinuing Study Treatment Due to an AE|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 28 days|Safety Population included all randomized participants who initiated study therapy.|||Number of Participants|||Number
2615088|NCT02004886|Primary|Number of Participants Experiencing an Adverse Event (AE)|An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product.|Up to 42 days|Safety Population included all randomized participants who initiated study therapy.|||Number of Participants|||Number
2615089|NCT02004886|Primary|Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4|Blood samples were collected 30 minutes prior to all meals, and 15, 30, 60, 90, 120, 180 minutes post-meal, then and at midnight, 3 AM, and the next morning at 6:30 AM and 7:30 AM. A 24-hour weighted mean glucose (WMG) was determined by averaging multiple plasma glucose measurements over a 24-hour period.|Baseline and Week 4|Completers Population was used for all efficacy analyses, and required that a participant took at least one dose of study therapy, had a baseline measurement, and had a post-randomization measurement in the treatment period at Week 4.|||mg/dL||95% Confidence Interval|Least Squares Mean
2615090|NCT02004873|Secondary|Rate Response Operation of Micra|Assessment of whether the Micra sensor-indicated rate derived from the input of the accelerometer during the Minnesota Pacemaker Response Exercise Protocol (M-PREP) treadmill test conducted at the 3-month and 6-month follow-up visits was proportional to the workload. The sensor-indicated rate (in min^-1) and workload (in METS) were normalized for each subject relative to their minimum and maximum possible values so the normalized values have a minimum possible value of zero and a maximum possible value of 1. These normalized values were used in a random effect linear regression model to assess the relationship between the sensor-indicated rate and workload via estimation of the Kay-Wilkoff slope parameter. The tests at 3-month and 6-month visits were combined in one analysis.|3 Months and 6 Months Post Implant (combined analysis)|Subjects implanted with Micra who had usable M-PREP test(s) at 3-month and/or 6-month visits.|||regression slope parameter|M-PREP tests|90% Confidence Interval|Mean
2615126|NCT02004366|Secondary|Acute Renal Failure During Hospitalization|Subjects with Acute renal failure (ONLY for inpatient arms 1 and 2)|During Hospitalization-average 5 days|Acute renal failure during hospitalization is applicable ONLY for inpatient arms (1 and 2)|||Participants|||Count of Participants
2615127|NCT02004366|Secondary|Hospital Complications|Subjects with composite complication (ONLY for inpatient arms 1 and 2)|During Hospitalization-average 5 days|Composite complication during hospitalization is applicable ONLY for inpatient arms (1 and 2)|||Participants|||Count of Participants
2615091|NCT02004873|Secondary|Ventricular Capture Management Threshold|Subjects that have a ventricular capture management threshold (VCMT) that is within 0.5 Volts of the manual (auto decrement) PCT (at 0.24 ms pulse width) at the 6-month post-implant visit. The VCMT is an automatically measured pacing capture threshold that is measured by the Micra device's pacing algorithm. In contrast, the manual (auto decrement) pacing capture threshold is measured by the clinician during a study visit.|6 Months Post Implant|Subjects implanted with Micra who had paired ventricular capture management PCT and auto decrement PCT data available at the 6-month visit.|||participants|||Number
2615092|NCT02004873|Primary|Pacing Capture Threshold|Subjects that have an adequate pacing capture threshold (PCT) at the 6-month post-implant visit, which is defined as PCT <=2 volts at 0.24 ms pulse width and the increase in PCT from implant to 6 months <=1.5 volts. The pacing capture threshold is the minimal electrical stimulus required to produce consistent cardiac depolarization. It is the minimum amount of energy that is required for a pacemaker to pace the heart.|6 Months Post Implant|Subjects implanted with Micra who had paired implant and 6-month auto decrement PCT values (at 0.24 ms), or who had a system modification or alternative device implant prior to 6 months due to elevated threshold.|||participants|||Number
2615093|NCT02004873|Primary|Major Complications|Micra system and/or procedure related major complication free rate at 6-months post-implant.|Implant to 6 Months Post Implant|All subjects who attempted Micra implant procedure|||Kaplan-Meier survival probability (%)||98.66% Confidence Interval|Number
2615094|NCT02004847|Other Pre-specified|Patient Acceptance of Hyperpigmentation|Questionaire|week 16|Safety set (SAF)|||percentage of participants|||Number
2615095|NCT02004847|Other Pre-specified|Thermal Comfort|Questionaire|week 12|Full Analysis Set|||percentage of participants|||Number
2615096|NCT02004847|Secondary|Adverse Device Events (Serious and Non-serious)|"Adverse device events: Adverse event related to the use of an investigational medical device wich led to any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons.~Serious adverse device event: Adverse device effect that has resulted in a) led to death, b) led to serious deterioration in the health of the subject, that either resulted in 1) a life-threatening illness or injury, or 2) a permanent impairment of a body structure or a body function, or 3) in-patient or prolonged hospitalization, or 4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, c) led to foetal distress, foetal death or a congenital abnormality or birth defect."|week 0, 1, 2, 4, 8, 12, 16|Safety Set (SAF)|||number of participants|||Number
2615097|NCT02004847|Other Pre-specified|Adverse Events (Serious and Non-serious)||week 0, 1, 2, 4, 8, 12, 16|Safety Set (SAF)|||number of participants|||Number
2615098|NCT02004847|Other Pre-specified|"Hyperpigmentation of Normal Skin Areas Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter"|Arbitrary units measured by mexameter. Mexameter readings ranged from 0 to 100. Higher values correspond to higher pigmentation levels.|week 4, 12, 16|Safety Set (SAF)|||arbitrary units||Standard Deviation|Mean
2615099|NCT02004847|Secondary|Total Duration of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)||week 16|Full Analysis Set (FAS); Not all patients requested co-use of vitamin D. Only 17 in HI group and 16 in LI group requested co-use of vitamin D|||days||Standard Deviation|Mean
2615100|NCT02004847|Secondary|Time to First Use of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI)||patients will be followed for the complete duration of the clinical study for 16 weeks|Full Analysis Set (FAS); Not all patients requested co-use of vitamin D. Only 17 in HI group and 16 in LI group requested co-use of vitamin D|||days||Standard Deviation|Mean
2615101|NCT02004847|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI)|It is a simple 10-question validated questionnaire. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. As the change from baseline is calculated negative values in the Outcome Measure Data indicate an improvement in quality of life.|baseline and week 12|Full Analysis Set (FAS)|||units on a scale||Standard Deviation|Mean
2615102|NCT02004847|Secondary|System Usability Scale|At the end of treatment (visit 7), the usability of the investigational device was evaluated by a questionnaire presented to the patient in German. The usability was evaluated by using the System Usability Scale (SUS) which is an effective tool for assessing the usability of a device. It provides an easy-to-understand score from 0 (negative) to 100 (positive).|week 12|Full Analysis Set (FAS); due to one drop out this number is 23 at week 12 for HI group. Only 17 of 22 patients completed the questionaire in the LI group.|||units on a scale||Standard Deviation|Mean
2615103|NCT02004847|Secondary|Change From Week 12 (End of Treatment) of Erythema Evaluated by Mexameter of the Target Area of High Intensity (HI) and Low Intensity (LI) as Compared to the Control Area at End of Follow-up|Erythema was measured directly after treatment. Mexameter readings ranged from 0 to 100. Higher values describe higher erythema levels.|week 12 and week 16|Full Analysis Set (FAS); due to one drop out in each group this number is 23 for HI Group and 22 for LI group at week 12 and 16|||arbitrary units||Standard Deviation|Mean
2615104|NCT02004847|Secondary|Change From Baseline of Erythema Evaluated by Mexameter of the Target Area of High Intensity (HI) and Low Intensity (LI) as Compared to the Control Area|Erythema was measured directly after treatment. Mexameter readings ranged from 0 to 100. Higher values describe higher erythema levels.|baseline and week 4, 12|Full Analysis Set (FAS)|||arbitrary units||Standard Deviation|Mean
2615105|NCT02004847|Secondary|Difference in Change From Baseline of Local Psoriasis Area Severity Index (PASI) Between Target and Control Area of the High Intensity (HI) Group as Compared to the Low Intensity (LI) Group|"In this study only the local PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:~0. = no sign~= slight~= moderate~= marked~= very marked A total severity score was calculated as the sum of the three symptom ratings (range 0-12)."|baseline and week 4, 8, 16|Full Analysis Set (FAS)|||units on a scale||Standard Deviation|Mean
2615128|NCT02004366|Secondary|Number of Participants Requiring ICU Care During Hospitalization|Need for intensive care unit (ICU) care (transfer to ICU) during hospitalization|During Hospitalization-average 5 days|Transfer to ICU is applicable ONLY for inpatient arms (1 and 2)|||Participants|||Count of Participants
2615106|NCT02004847|Secondary|Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (Low Intensity (LI) Group) as Compared to the Control Area by Week.|"In this study only the local PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:~0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked~A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst))."|baseline and week 4, 12, 16|Full Analysis Set (FAS)|||units on a scale||Standard Deviation|Mean
2615107|NCT02004847|Secondary|Change From Week 12 of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity) as Compared to the Control Area at End of Follow-up|"In this study only the local PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:~0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked~A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst))."|Week 12 and week 16|Full Analysis Set (FAS); due to one drop out this number is 23 at week 12 and 16|||units on a scale||Standard Deviation|Mean
2615108|NCT02004847|Secondary|Change From Baseline of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity) as Compared to the Control Area at End of Treatment During the Attack Period (Week 4, Visit 5)|"In this study only the local PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:~0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked~A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst))."|baseline and week 4|Full Analysis Set|||units on a scale||Standard Deviation|Mean
2615109|NCT02004847|Primary|Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity (HI) Group) as Compared to the Control Area at End of Treatment (Visit 7, Week 12).|"In this study only the local PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale:~0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked~A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst))."|baseline and week 12|Full Analysis set (FAS)|||units on a scale||Standard Deviation|Mean
2615110|NCT02004522|Secondary|Number of Subjects With Samples Available for Duvelisib Pharmacokinetics (PK)|Number of subjects with samples available for duvelisib Pharmacokinetics (PK)|Cycle 2, Cycle 3, and Cycle 7|Intent to Treat for duvelisib patients, no PK samples were collected for ofatumumab patients.|||participants|||Number
2615111|NCT02004522|Secondary|Treatment- Emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values|An analysis of TEAEs with an onset within the first 24 weeks of treatment was performed to examine and compare the incidence of events across an equal period for each treatment arm.Twenty-four weeks was anticipated to be the median exposure to ofatumumab.|04 Feb 2014 - 19 June 2018|Intent to Treat|||Participants|||Count of Participants
2615112|NCT02004522|Secondary|Duration of Response (DOR)|Duration of response is defined only for subjects demonstrating a response (eg, CR, CRi, PR, PRwL), with the response and progression statuses both determined by the blinded, central independent review. The analysis will be descriptive for each treatment group only.|Time from the first documentation of response to first documentation of progressive disease or death due to any cause|Intent to Treat|||Months||95% Confidence Interval|Median
2615113|NCT02004522|Secondary|Lymph Node Response Rate|Lymph node response defined as greater than or equal to 50% decrease in the SPD of target lymph nodes|3 years|Intent to Treat|||Participants|||Count of Participants
2615114|NCT02004522|Secondary|Overall Survival|A stratified Cox regression analysis was used to test for any treatment effect.|Every 6 months for up to 3 years after first dose|Intent to Treat|||Months||95% Confidence Interval|Median
2615115|NCT02004522|Secondary|Number of Subjects With Hematologic Improvements|Subjects with hematologic improvement included those subjects with abnormally high values for neutrophil count, hemoglobin, or platelet count at Baseline determined to have consistently met the criteria of an improvement for those parameters for a period of at least 60 days during which the subject did not have a transfusion or exogenous cytokines.|3 years|Subjects With Abnormal Hematologic Values at Baseline|||Participants|||Count of Participants
2615116|NCT02004522|Secondary|Overall Response Rate (ORR)|ORR is a key secondary efficacy endpoint with overall response defined as best response of CR, CRi, PR, or PRwL, according to the modified IWCLL/IWG Response Criteria, with modification for treatment-related lymphocytosis as defined in the protocol.|Until disease progression or unacceptable toxicity assessed up to 6 years|Intent to Treat|||Participants|||Count of Participants
2615117|NCT02004522|Primary|Progression-free Survival (PFS)|The primary efficacy endpoint for the study was PFS, defined as time from randomization to the first documentation of PD as determined by blinded independent review or death due to any cause.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years|Intent to Treat|||Months||95% Confidence Interval|Median
2615118|NCT02004366|Secondary|Outpatient Mortality|Deaths among patients after hospital discharge.|3 months after discharge|Deaths after hospital discharge are applicable ONLY for outpatient arms (3, 4 and 5).|||Participants|||Count of Participants
2615119|NCT02004366|Secondary|Subjects With Surgical Reinterventions|Subjects with surgical re-interventions.|Inpatient and up to 12 weeks outpatient||||Participants|||Count of Participants
2615120|NCT02004366|Secondary|Emergency Room Visits|Number of ER visits ONLY for outpatient arms 3,4, and 5.|3 months after discharge|Emergency visits reported only for outpatient time. Inpatient (hospital) patients cannot have ER visits|||Visits|||Number
2615121|NCT02004366|Secondary|Hypoglycemia < 40 mg/dl|Subjects with Hypoglycemia < 40 mg/dl|Inpatient and up to 12 weeks outpatient||||Participants|||Count of Participants
2615122|NCT02004366|Secondary|HbA1c Level|HbA1c level at admission (for in-patient arms) and HbA1c level at 12-week follow-up outpatient visit (for discharge arms).|Admission to the hospital and 12-week follow-up outpatient visit||||% DCCT||Standard Deviation|Mean
2615134|NCT02004262|Secondary|Number of Participants With Adverse Events in Each Treatment Arm Treatment Regimen|Safety was assessed based upon the number of adverse events (AEs) that occurred in the FAS of each treatment arm, including serious AEs and total AEs. Total AEs included both serious and non-serious AEs.|From the start of the first study drug administration on Day 1, Week 1, through 28 days after the last study drug dose, assessed up to 32 months from the date of randomization.|Analysis conducted for the FAS of each study arm.|||Participants|||Count of Participants
2615135|NCT02004262|Primary|2nd-line Cohort: OS (All Data, FAS)|For all treated subjects, OS was calculated using KM methods with 70% CIs. Subjects without documentation of death at the time of the analysis were censored as of the date the subject was last known to be alive on/prior to the final analysis cut. 70% CIs were selected to provide an 80% probability to rule out differences in median survival less than -2.4 months between the 2nd-line Cohort: Chemotherapy arm and the 2nd-line Cohort: Cy/GVAX + CRS-207 and 2nd-line Cohort: CRS-207 arms, based upon the assumptions made in the statistical analysis plan (SAP).|Subjects followed for survival from date of randomization until lost to follow-up, withdrawal of consent, or death, whichever came first, assessed up to 32 months.|Analysis based on subjects in the 2nd-line Cohort in the FAS.|||months||70% Confidence Interval|Median
2615136|NCT02004262|Primary|Primary Cohort: OS (All Data, FAS)|For all treated subjects, OS was calculated using KM methods with 95% CIs. Subjects without documentation of death at the time of the analysis were censored as of the date the subject was last known to be alive on/prior to the final analysis data cut.|Subjects followed for survival from date of randomization until lost to follow-up, withdrawal of consent, or death, whichever came first, assessed up to 32 months.|Analysis based on subjects in the Primary Cohort in the FAS.|||months||95% Confidence Interval|Median
2615137|NCT02004262|Primary|Primary Cohort: Overall Survival (OS) Censored at 138 Deaths (ITT Set)|OS was estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs), with censoring at the date when 138 deaths were reached in the Primary Cohort in the FAS. Subjects without documentation of death at the time of final analysis were censored as of the date the subject was last known to be alive on/prior to the primary analysis data cut.|Subjects were followed from date of randomization to the date of death by any cause, whichever came first, assessed up to 32 months. Analysis conducted when 138 deaths reached in the Primary Cohort in the FAS.|Analysis based on subjects in the Primary Cohort in the intent-to-treat (ITT) set. The ITT set is the analysis population that included all randomized study subjects.|||months||95% Confidence Interval|Median
2615138|NCT02004236|Secondary|P3b Wave Amplitude After tRNS|ERP and behaviour Changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions||||MicroVolts||Standard Deviation|Mean
2615139|NCT02004236|Secondary|Commission Errors After tRNS|ERP and behaviour Changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions||||number of errors during ECPT task||Standard Deviation|Mean
2615140|NCT02004236|Secondary|Ommision Errors After tRNS|ERP and behaviour Changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions||2017-12-31|12/2017||||
2615141|NCT02004236|Secondary|Reaction Time After tRNS|ERP and behaviour Changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions||||Milliseconds||Standard Deviation|Mean
2615142|NCT02004236|Secondary|P3b Wave Amplitude Before tRNS|ERP and behaviour Changes in ASD children before tRNS|During 3 months of intensive speech therapy during tRNS sessions||||MicroVolts||Standard Deviation|Mean
2615143|NCT02004236|Secondary|Commission Errors Before tRNS|ERP and Behaviour changes in ASD children before tRNS|During 3 months of intensive speech therapy during tRNS sessions||||number of errors during ECPT task||Standard Deviation|Median
2615144|NCT02004236|Secondary|Omission Errors Before tRNS|ERP and behaviour changes in ASD children before tRNS|During 3 months of intensive speech therapy during tRNS sessions||||number of errors during ECPT task||Standard Deviation|Mean
2615145|NCT02004236|Secondary|Reaction Time in ECPT Before tRNS|ERP & Behaviour changes in ASD children after tRNS|During 3 months of intensive speech therapy during tRNS sessions||||Milliseconds||Standard Deviation|Mean
2615146|NCT02004236|Secondary|Theta Amplitude in T5 After tRNS|Evaluate QEEG (brainwave changes in frequency bandfs and amplitude) after tRNS intervention in ASD children between 5 and 12 years old|During 3 months of intensive speech therapy during tRNS sessions||||MicroVolts||Standard Deviation|Mean
2615147|NCT02004236|Secondary|Ratio Theta/Beta After tRNS|The purpose of the present study was to determine if the theta/beta ratio, and theta and beta separately, correlate with behavioral parameters, and if these measures discriminate between children a with Autism Spectrum disorder (ASD) and normal gender- and age-matched controls before and after tRNS intervention in ASD children between 5 and 12 years old.|During 3 months of intensive speech therapy during tRNS sessions||||Ratio theta/beta after tRNS||Standard Deviation|Mean
2615148|NCT02004236|Secondary|Theta Amplitude in T5 Before tRNS|The purpose of the present study was to determine if the theta/beta ratio, and theta and beta separately, correlate with behavioral parameters, and if these measures discriminate between children a with Autism Spectrum disorder (ASD) and normal gender- and age-matched controls before and after tRNS intervention in ASD children between 5 and 12 years old.|During 3 months of intensive speech therapy during tRNS sessions||||MicroVolts||Standard Deviation|Mean
2615149|NCT02004236|Secondary|Ratio Theta/Beta Before tRNS|The purpose of the present study was to determine if the theta/beta ratio, and theta and beta separately, correlate with behavioral parameters, and if these measures discriminate between children a with Autism Spectrum disorder (ASD) and normal gender- and age-matched controls before and after tRNS intervention in ASD children between 5 and 12 years old.|During 3 months of intensive speech therapy during tRNS sessions||||Ratio theta/beta before tRNS||Standard Deviation|Mean
2615164|NCT02004093|Secondary|Kaplan-Meier Probability of Being Progression Free at 1 Year||1 year|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 16 and 10 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.|||percent|||Number
2615637|NCT01998906|Primary|Percentage of Participants Event Free at 3 Years||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS|||percentage of participants||95% Confidence Interval|Number
2615150|NCT02004236|Primary|Sociability|"Goal: Evaluate emphaty with CARS scale in autism spectrum disorder children between 5 and 12 years after tRNS sessions.~CARS (Childhood Autism Rating Scale) by Shopler & Reichler (1971) in Spanish version EVAI (Escala de Valoración de Autismo Infantil) by Leal-Soto, F.; Aguirre, L.P. y Williams, E.E.~Description: 15 items in the scale that evaluate: Relating to people, Imitative Behavior, Emotional Response, Body Use, Object Use, Adaptation to Change, Visual Response, Listening Response, Perceptive Response, Fear or Anxiety, Verbal Communication, Non-Verbal Communication, Activity level, Level and consistency of Intellective Relations and General Impressions.~Values: The CARS scores range from 15 to 60, with lower scores indicating better outcome. It classifies the child as not autistic (below 30), moderately autistic (30-36.5) or severely autistic (above 36.5)"|During 3 months of intensive speech therapy during tRNS sessions|Time frame: Baseline Before treatment and after completing 3 months of intensive speech therapy during tRNS sessions.|||units on a scale||Standard Deviation|Mean
2615151|NCT02004236|Primary|Verbal Fluency|"Goal: Improve in verbal fluency in ASD children between 5 and 12 years. We use D-KEFS (Delis-Kaplan Executive Function System Delis Kaplan Sorting Test), Verbal Fluency Subtest - Category Condition.~Description: The verbal fluency Category test evaluates fluent productivity in the verbal domain by asking participants to generate exemplars belonging to the category animals, and subsequently, boys´ names. Participants were given 60 s to do it.~Values: Category scores were based on the average number of items generated in the two categories (animals and boys´names) during 60 s.~Time Frame: Baseline (Before treatment) and 1 day Post-treatment (after completing 3 months of intensive speech therapy during tRNS sessions)"|During 3 months of intensive speech therapy during tRNS sessions|Time frame: Baseline Before treatment and after completing 3 months of intensive speech therapy during tRNS sessions.|||units on a scale||Standard Deviation|Mean
2615152|NCT02004158|Secondary|Objective Psychological Impact of Exercises|"Object psychological impact of exercises will be measured by clinician-administered questionnaires given at baseline and again at 8 weeks. These questionnaires include:~Life Orientation Test-Revised (scores range from 6-30; a high score means higher optimism)~Positive and Negative Affect Schedule (scores range from 10-50; a higher score means higher levels of affect)~Hospital Anxiety and Depression Scale (scores range from 0-42; a high score means higher depression and anxiety).~Objective psychological impact will be defined as having significantly improved scores at 8 weeks as compared to scores at baseline."|8 weeks||||points||Standard Deviation|Mean
2615153|NCT02004158|Primary|Self-reported Psychological Impact of Exercises|Psychological impact of exercises will be measured by two self-reported 10-point Likert scales. One scale measures optimism after completing the exercise (0=not optimistic, 10=very optimistic), and the other scale measures happiness after completing the exercise (0=not happy, 10=very happy). Psychological impact will be defined as an average score of 6 or more on both of these scales.|8 weeks||||points||Standard Deviation|Mean
2615154|NCT02004158|Primary|Ease of Exercises|Ease of exercises will be measured by a self-report 10-point Likert scale (0=not easy to complete, 10=very easy to complete). Ease will be defined as an average score of 6 or more on this scale.|8 weeks||||scores on a scale||Standard Deviation|Mean
2615155|NCT02004158|Primary|Rate of Exercise Completion|Rate of exercise completion will be measured by the number of participants who have a good rate of completion of exercises. There are 8 exercises in total. A good rate of completion will be defined as an average of 5 or more exercises completed per subject.|8 weeks||||Participants|||Number
2615156|NCT02004132|Secondary|Amount of Testosterone on Unworn Textiles Laundered With the Testosterone Exposed T-shirts|"This is a summary of the amounts of testosterone measured on unworn textile items washed with t-shirt halves exposed to testosterone in a standard washing machine. Total amounts of testosterone on each laundered item other than the t-shirt halves was calculated based on the weight of the fabric sample analyzed and the total weight of the item, assuming a uniform distribution of testosterone across each item as:~(weight of laundered item / weight of laundered sample) x amount of testosterone on laundered sample."|12 hours after application of study drug|FAS. Data from all enrolled participants completing the study.|||µg||Standard Deviation|Mean
2615157|NCT02004132|Secondary|Amount of Testosterone Following Laundering|This is a summary of the amounts of testosterone measured on a 10 cm × 10 cm of material excised from the underarm area of washed t-shirt halves following laundering in a standard washing machine.|12 hours after application of study drug|FAS. Data from all enrolled participants completing the study.|||µg||Standard Deviation|Mean
2615158|NCT02004132|Primary|Amount of Testosterone on T-shirts|This is a summary of the amounts of testosterone measured on a 10 centimeters (cm) × 10 cm of material excised from the underarm area of participant's unwashed t-shirt halves.|12 hours after application of study drug|Full analysis set (FAS). Data from all enrolled participants completing the study.|||micrograms (µg)||Standard Deviation|Mean
2615159|NCT02004093|Secondary|Kaplan-Meier Probability of Being Alive at 1 Year||1 year|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.|||percent|||Number
2615160|NCT02004093|Secondary|Overall Survival|Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment|All treated participants were included in analysis|||months||Full Range|Median
2615161|NCT02004093|Secondary|Percentage of Participants Who Died||Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment|All treated participants were included in analysis|||percentage of participants|||Number
2615162|NCT02004093|Secondary|Time To Response|Time to response was the date of first dose of study medication to the date of the first documentation of response, according to CA 125 criteria for all participants or response according to RECIST criteria for participants with measurable disease. If response was evaluable by both criteria, then the date of response was for the earlier of the two events.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until 2 years after last dose of treatment|Only participants with a response were included in the analysis.|||weeks||Inter-Quartile Range|Median
2615177|NCT02003963|Primary|Change in Resting Systolic Blood Pressure Percentile|Resting systolic blood pressure percentile|Baseline clinic visit (week 0) and final clinic visit (week 13)||||%ile||Standard Deviation|Mean
2615165|NCT02004093|Secondary|Time to Progressive Disease|The time to progressive disease is the interval of time from date of first dose of study medication to date of first documentation of progressive disease by either RECIST or CA 125 criteria. Participants who never progressed while being followed were censored at the last valid tumor measurement or CA 125 measurement.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression|All treated patients with an event (disease progression) were included in analysis|||weeks||Inter-Quartile Range|Median
2615166|NCT02004093|Secondary|Percentage of Participants With Disease Progression|Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression|All treated participants were included in analysis|||percentage of participants|||Number
2615167|NCT02004093|Secondary|Kaplan-Meier Probability of Maintaining a Response to at Least 1 Year||1 year|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis. 7 and 5 participants in the chemotherapy + pertuzumab and chemotherapy treatment groups, respectively, remained at risk.|||percent|||Number
2615168|NCT02004093|Secondary|Duration of Response|For participants who achieved a response, the duration of response was defined as the interval between initial documentation of response to the first documentation of disease progression or death. Participants who responded and did not progress or die while on study or while being followed were censored at the last valid tumor or CA 125 measurement.|Day 15 of Cycles 2, 4, 6, and Day 15 of all Cycles from Cycle 7 to 17 until disease progression up to 104 weeks|Only participants with a response were included in the analysis; 8 participants and 13 participants were censored in the chemotherapy + pertuzumab and chemotherapy only treatment groups, respectively.|||weeks||Inter-Quartile Range|Median
2615169|NCT02004093|Secondary|Percentage of Participants With a Best Overall Confirmed Response Based on Combined CA 125 and RECIST Measurements|"Response by tumor measurement occurred if there was documented and confirmed complete response (CR) or partial response (PR). For all participants, response was assessed by both the RECIST and by CA 125 levels, according to whether the participant had measurable or non-measurable disease at baseline. Response according to CA 125 levels was defined as at least a 50% reduction from baseline. The decrease had to be confirmed and maintained for at least 28 days. The confirmatory sample must have been less than or equal to the previous sample (within an assay variability of 10%). For overall response, the response categories were response, stable disease and progressive disease. Stable disease included 1) stable disease as defined by RECIST for solid tumors and 2) CA 125 levels that had not met the definition of response or progressive disease."|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.|||percentage of participants|||Number
2615170|NCT02004093|Primary|Progression-Free Survival|Progression-free survival was defined as the time from first administration of study drug (Study Day 1) to documented disease progression or death, whichever occurred earlier. Disease progression was assessed according to RECIST, for participants with measurable disease, or by changes in CA 125 according to GCIG for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks|All treated patients who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.|||weeks||Full Range|Median
2615171|NCT02004093|Primary|Percentage of Participants With Disease Progression or Death|Disease progression was assessed according to RECIST (Response Evaluation Criteria In Solid Tumors), for participants with measurable disease, or by changes in CA 125 (Cancer Antigen 125) according to GCIG (Gynecologic Cancer Inter Group) for all participants. Participants who did not progress or died while being followed were censored at the time of the last valid tumor assessment or valid CA 125 assessment.|Screening and Day 15 of Cycles 2, 4, 6, and Day 15 of all cycles from Cycle 7 to 17 until disease progression up to 104 weeks|All treated participants who received Randomized Treatment (All Treated Population, for Efficacy Analyses) were included in analysis.|||percentage of participants|||Number
2615172|NCT02003963|Secondary|Change From Baseline in Self-efficacy Towards Exercise on the Self-Efficacy for Healthy Eating and Physical Activity Measure (SE-HEPA) at Week 13|SE-HEPA is a 13-item self-report survey with items based on a 5-point Likert scale. Possible scores range from 1 (Disagree a Lot) to 5 (Agree a Lot). The items are summed to a total score, and a higher score indicates a higher level of self-efficacy (range: 13 to 65). Results are reported as change scores from baseline.|Baseline clinic visit (Week 0) and final clinic visit (Week 13)|Four participants refused to complete the final assessment.|||change scores on a scale||Standard Deviation|Mean
2615173|NCT02003963|Secondary|Change From Baseline in Health-related Quality of Life|Self-report instrument to capture health-related quality of life (KIDSCREEN-10 Index). The scale ranges from 5 to 50, with a higher score indicating a better quality of life.|Baseline clinic visit (week 0) and final clinic visit (week 13)||||change in units on a scale||Standard Error|Mean
2615174|NCT02003963|Secondary|The Friendship Quality Questionnaire to Measure Change in Peer Support From Baseline to Week 13.|The outcome is perceived peer conflict from the Friendship Quality Questionnaire, which is a 21-item self-report survey in which the participant answers questions about his or her best friend related to companionship, conflict, help/aid, security, and closeness, on a 5-point Likert scale. The survey is internally consistent, with α ranging from 0.71 to 0.86, and adequate criterion validity across sub-scales. The peer conflict sub-scale includes four questions and ranges from 4 to 20 points. A higher score indicates higher (worse) levels of peer conflict.|Baseline clinic visit (week 0) and final clinic visit (week 13)||||change in units on a scale||Standard Error|Mean
2615175|NCT02003963|Secondary|Change in Physical Activity|Actigraph accelerometer (7-day protocol using waking hours) and self-report instrument|Baseline clinic visit (week 0) and final clinic visit (week 13)|Data reported on participants with complete accelerometry data|||change in self-reported days/week of PA||Full Range|Mean
2615176|NCT02003963|Secondary|Feasibility (Adherence)|Attendance to exergaming intervention|3 gaming sessions/week for 12 weeks|"Attendance was only assessed for the Exergame Intervention participants"|||percentage exergaming sessions attended||Full Range|Mean
2615180|NCT02003924|Secondary|Number of Participants With Clinically Significant Vital Signs|Vital signs included Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and heart rate.|From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).|||participants|||Number
2615181|NCT02003924|Secondary|Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Chemistry|Chemistry parameters: Alanine aminotransferase (units per liter [U/L]); albumin (g/L); alkaline phosphatase (U/L); bilirubin (micromoles per liter [umol/L]); calcium (millimoles per liter [mmol/L]); creatine kinase (U/L); creatinine (umol/L); glucose, magnesium, phosphate, potassium, sodium (mmol/L).|From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).|||participants|||Number
2615182|NCT02003924|Secondary|Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Hematology|Hematology parameters: Haemoglobin (grams per liter [g/L]); leukocytes (log 10 raised to power 9 per liter [10*9/L]); lymphocytes (log 10 raised to power 6 per liter [10*6/L]); neutrophils (log 10 raised to power 6 per liter [10*6/L]); platelets (log 10 raised to power 9 per litre [10*9/L]).|From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).|||participants|||Number
2615183|NCT02003924|Secondary|Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious adverse events (AEs) and SAEs.|From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).|||participants|||Number
2615184|NCT02003924|Secondary|Number of Participants With Treatment-Emergent Adverse Events Greater Than or Equal to Grade 3, Based on National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE), Version 4.0|An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE, Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug through the date of last dose +30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first).Number of participants with AEs of any of the Grade 3 or above (Grade 4, 5) were reported.|From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).|||participants|||Number
2615185|NCT02003924|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug through the date of last dose +30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first). AEs included both non-serious adverse events (AEs) and SAEs.|From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The safety population was defined as all participants randomly assigned to receive at least 1 dose or partial dose of study drug (enzalutamide or placebo) according to the actual treatment received (not the treatment assigned).|||participants|||Number
2615217|NCT02003924|Secondary|Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score|The FACT-P questionnaire is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess prostate-related symptoms. Each item was rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which ranged from 0 to 156 where higher scores represented better quality of life.|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2615186|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 55|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 55 are reported. Question 55 was following: Have you felt uncomfortable about being sexually intimate?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615187|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 54|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 54 are reported. Question 54 was following: Did you have ejaculation problems (e.g, dry ejaculation)?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615188|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 53|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 53 are reported. Question 53 was following: Did you have difficulty getting or maintaining an erection?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615189|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 52|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 52 are reported. Question 52 was following: To what extent was sex enjoyable for you?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615190|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 51|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 51 are reported. Question 51 was following: To what extent were you sexually active (with or without intercourse)?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615191|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 50|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 50 are reported. Question 50 was following: To what extent were you interested in sex?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615696|NCT01998399|Other Pre-specified|Need for Re-instituting Assisted or Mechanical Ventilation After Achieving 48 Consecutive Hours of Unassisted Breathing or Comfort Care Chosen (Withdrawal of Support)||90 days|only participants that required mechanical ventilation|||Participants|||Count of Participants
2615192|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 49|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 49 are reported. Question 49 was following: Have you felt less masculine as a result of your illness or treatment?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615193|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 48|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 48 are reported. Question 48 was following: Has weight gain been a problem for you?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615194|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 47|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 47 are reported. Question 47 was following: Has weight loss been a problem for you?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615195|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 46|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 46 are reported. Question 46 was following: Have you had swelling in your legs or ankles?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615196|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 45|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 45 are reported. Question 45 was following: Have you had sore or enlarged nipples or breasts?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615197|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 44|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 44 are reported. Question 44 was following: Did you have hot flushes?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615638|NCT01998906|Secondary|Percentage of Participants Surviving at 2 Years||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS|||percentage of participants||95% Confidence Interval|Number
2615198|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 43|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 43 are reported. Question 43 was following: Did you have a bloated feeling in your abdomen?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615199|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 42|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 42 are reported. Question 42 was following: Have you had blood in your stools?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615200|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 41|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 41 are reported. Question 41 was following: Have you had any unintentional release (leakage) of stools?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615201|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 40|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 40 are reported. Question 40 was following: Have your daily activities been limited by your bowel problems?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615202|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 39|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 39 are reported. Question 39 was following: Have your daily activities been limited by your urinary problems?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615203|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 38|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 38 are reported. Question 38 was following: Has wearing an incontinence aid been a problem for you?. This question was answered by only those participants who wore incontinence aid."|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2620546|NCT01954160|Secondary|Plasma N-terminal Pro-brain Natriuretic Peptide||13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2615204|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 37|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 37 are reported. Question 37 was following: Did you have pain when you urinated?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615205|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 36|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 36 are reported. Question 36 was following: Have you had any unintentional release (leakage) of urine?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615206|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 35|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 35 are reported. Question 35 was following: Have you had difficulty going out of the house because you needed to be close to a toilet?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615207|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 34|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 34 are reported. Question 34 was following: Was it difficult for you to get enough sleep, because you needed to get up frequently at night to urinate?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615208|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 33|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 33 are reported. Question 33 was following: When you felt the urge to pass urine, did you have to hurry to get to the toilet?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615209|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 32|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 32 are reported. Question 32 was following: Have you had to urinate frequently at night?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2620547|NCT01954160|Secondary|Left Atrial Size|Echo: Left Atrial size|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2615210|NCT02003924|Secondary|Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 31|"The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 31 are reported. Question 31 was following: Have you had to urinate frequently during the day?"|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615211|NCT02003924|Secondary|European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Status Visual Analog Score (VAS)|EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2615212|NCT02003924|Secondary|Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Anxiety/ Depression Domain Score|EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the anxiety/depression questionnaire are reported.|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615213|NCT02003924|Secondary|Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Pain/Discomfort Domain Score|EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the pain/discomfort questionnaire are reported.|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615214|NCT02003924|Secondary|Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Usual Activities Domain Score|EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the usual activities questionnaire are reported.|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified categories.|||participants|||Number
2615215|NCT02003924|Secondary|Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Self-Care Domain Score|EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the self-care questionnaire are reported.|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||participants|||Number
2615216|NCT02003924|Secondary|Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Mobility Domain Score|EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the mobility questionnaire are reported.|Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||participants|||Number
2620548|NCT01954160|Secondary|LV End Diastolic Dimension (LVEDd)|Echo: LV end diastolic dimension (LVEDd)|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2615218|NCT02003924|Secondary|Percentage of Participants With Prostate Specific Antigen (PSA) Response|PSA response was calculated at each visit as a decline from baseline in PSA (ng/mL) to the maximal PSA response with thresholds at 50% and 90%. Additionally, PSA response was assessed as a decline to undetectable levels, where undetectable level was defined as below the limit of quantification of the centrally assessed PSA results (the lower limit of quantification was 0.02 ng/mL). PSA response was confirmed by a second consecutive value at least 3 weeks later.|From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered. Here, ‘Overall number of participants analyzed’ = participants with baseline and at least one post-baseline PSA assessment.|||percentage of participants||95% Confidence Interval|Number
2615219|NCT02003924|Secondary|Chemotherapy-Free Survival|Chemotherapy-free survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died at the time of analysis were censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.|From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.|||months||95% Confidence Interval|Median
2615220|NCT02003924|Secondary|Chemotherapy-Free Disease Specific Survival|Chemotherapy-free disease-specific survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer as assessed by the investigator. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died due to prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.|From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.|||months||95% Confidence Interval|Median
2615221|NCT02003924|Secondary|Time to First Use of Cytotoxic Chemotherapy|Time to first use of cytotoxic chemotherapy was defined as the time from randomization to the first use of cytotoxic chemotherapy for prostate cancer. Participants not starting treatment with a cytotoxic chemotherapy for prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.|From randomization up to the first use of cytotoxic chemotherapy (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.|||months||95% Confidence Interval|Median
2615222|NCT02003924|Secondary|Time to Pain Progression|"Pain was assessed using the score from the Brief Pain Inventory-Short Form (BPI-SF) question 3: Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours. Time to this event was defined as the time from randomization to onset of pain progression, where pain progression was defined as a 2-point or more increase from baseline in the question 3 score. Participants without observed pain progression at the time of analysis were right censored at the date of last pain assessment for the purposes of analysis. Analysis was based on Kaplan-Meier estimates."|From randomization until onset of pain progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.|||months||95% Confidence Interval|Median
2615223|NCT02003924|Secondary|Overall Survival|Overall survival (OS) was defined as the time (in months) from randomization to death from any cause. For participants who were alive at the time of the analysis data cutoff, OS time was censored at the last date the participant was known to be alive or analysis data cutoff date, whichever was earlier. Participants with no post baseline survival information were censored on the date of randomization. Analysis was based on Kaplan-Meier estimates.|From randomization until death or discontinuation from the study whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.|||months||95% Confidence Interval|Median
2615224|NCT02003924|Secondary|Time to First Use of New Antineoplastic Therapy|Time to first use of new antineoplastic therapy was defined as the time from randomization to first use of new antineoplastic for prostate cancer. Participants not starting treatment with a new antineoplastic therapy at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.|From randomization until first use of new antineoplastic therapy(until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.|||months||95% Confidence Interval|Median
2615237|NCT02003391|Secondary|Percentage Change From Baseline in IOP (8AM) at Week 4 in the Study Eye|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4|Intent to treat with a measurement in the study eye at Week 4|||Percent Change||Standard Deviation|Mean
2615238|NCT02003391|Secondary|Mean Change From Baseline in IOP (8AM) at Week 4 in the Study Eye|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in mmHg. A negative change indicates an improvement. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4|Intent to treat with a measurement in the study eye at Week 4|||mmHg||Standard Deviation|Mean
2615225|NCT02003924|Secondary|Time to Prostate-Specific Antigen (PSA) Progression|Time to PSA progression was defined as the time from randomization to the date of first PSA value demonstrating progression, which was subsequently confirmed. For participants with PSA decline at Week 17, PSA progression was defined according to Prostate Cancer Working Group 2 (PCWG2) guidelines as the date that a 25% or greater increase and an absolute increase of 2 nanograms per milliliter (ng/mL) above the nadir (or baseline for participants with no PSA decline by Week 17) was documented, which was confirmed by a second consecutive value obtained at least 3 weeks or later. Participants without confirmed PSA progression at the time of analysis were right censored at the date of last PSA assessment before the analysis data cut-off date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.|From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.|||months||95% Confidence Interval|Median
2615226|NCT02003924|Primary|Metastasis Free Survival (MFS)|MFS:time from randomization to first date of radiographic progression (RP) (by Blinded independent central radiology review [BICR]) at any time or death within 112 days of treatment discontinuation without evidence of RP.RP for bone disease:appearance of 1 or more metastatic lesions on bone scan.RP for soft tissue disease:per Response Evaluation Criteria in Solid Tumors,[RECIST 1.1])-at least a 20 percent (%) increase in the sum of diameters of target lesions,taking as reference the smallest sum on study (includes the baseline sum if smallest on study).Participants who did not have MFS event at the time of analysis data cut-off (28 June 2017) were censored at date of last assessment showing no objective evidence of RP prior to skeletal-related event or two or more consecutive missed tumor assessments. Participants who were randomized but later confirmed to have metastatic disease before randomization were censored on date of randomization. Analysis was based on Kaplan-Meier estimates.|From randomization until radiographic progression at any time, or death within 112 days of treatment discontinuation, whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)|The intent-to-treat (ITT) population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.|||months||95% Confidence Interval|Median
2615227|NCT02003898|Secondary|Mean Change in A1C From Baseline to 1 Year, Baseline A1c > 9%|Mean Change in A1C From Baseline to 1 year, for subjects with Baseline A1c > 9%|1 year||||percentage||Standard Deviation|Mean
2615228|NCT02003898|Secondary|Mean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9%|Mean Change in A1C From Baseline to 1 Year, for subjects with Baseline A1c of 7% to 9%|1 year||||percentage||Standard Deviation|Mean
2615229|NCT02003898|Secondary|Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7%|Mean Change in A1C From Baseline to 1 Year, for subjects with baseline A1c below 7%.|1 year||||percentage||Standard Deviation|Mean
2615230|NCT02003898|Primary|Mean Change in A1C From Baseline to 1 Year|"Comparison of A1C measurement from baseline to end of study in the CEP266 study population.~The overall mean change in A1C from baseline will be estimated and compared by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided) with the CEP 266 study population."|1 year|Among the 372 enrolled subjects, 298 had both baseline and end of study A1c.|||percentage||95% Confidence Interval|Mean
2615231|NCT02003638|Primary|Change From Baseline in Arterial Fluorodeoxyglucose (FDG) Uptake Assessed by FDG-PET/CT||12 weeks||||Target to Background Ratio (TBR)||Standard Deviation|Mean
2615232|NCT02003573|Primary|Number of Subjects With Dose Limiting Toxicities (DLT) in Cycle 1|Number of subjects with Dose Limiting Toxicities (DLT) in Cycle 1 is presented|4 weeks|TS. One patient treated with volasertib 350 mg + decitabine had to be excluded because they did not receive all planned doses of volasertib and could therefore not be included in the calculation of MTD. Thus 3 patients were analysed instead of 4 patients for volasertib 350 mg + decitabine arm.|||participant|||Number
2615233|NCT02003573|Primary|Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in Cycle 1|"The primary objective of the dose-escalation part of this study was to determine the MTD of volasertib in combination with decitabine. The MTD was to be identified based on the DLT information collected during the first treatment cycle of each dosing schedule. DLT was defined as a non-haematological drug-related toxicity of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3.~The MTD corresponded to the highest dose of volasertib and decitabine at which the incidence of DLT was ≤17% (i.e. 1/6 patients) during Cycle 1."|4 weeks|TS. One patient treated with volasertib 350 mg + decitabine had to be excluded because they did not receive all planned doses of volasertib and could therefore not be included in the calculation of MTD. Thus overall 12 patients were analysed instead of 13 patients.|||Milligram (mg)|||Number
2615234|NCT02003534|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Month 3|Intent-to-Treat: patients with baseline data and data at the indicated time point|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2615235|NCT02003508|Primary|Prevalence of Penile HPV Genotypes|"Prevalence of penile HPV genotypes among heterosexually active young men. Percentage of participants with specific genotypes on penile samples, as detected by Linear Array.~Participants provided a single penile sample."|Single study visit (one time point per participant)|All participants in group one were ineligible for school-based vaccination. All participants in group two were eligible to receive 4vHPV vaccination. All participants had experienced sexual contact with a female (either oral or vaginal sex), no sexual contact (either oral or anal sex) with a male, and had assessable penile samples.|||percentage of participants||95% Confidence Interval|Number
2615236|NCT02003404|Primary|Skin Barrier Peel Force|Peel force of barrier materials, comparing peristomal skin to abdominal skin. A portable peel force analyser, previously validated, was used in the clinic to measure peel at 90 degrees to the plane of the body. Peel force was measured on peristomal skin and ipsilateral abdominal skin in the same subject.|4 hours||||grams||Standard Deviation|Mean
2615639|NCT01998906|Primary|Percentage of Participants Event Free at 2 Years||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS|||percentage of participants||95% Confidence Interval|Number
2615239|NCT02003391|Primary|Least Squares Mean Intraocular Pressure (IOP) at 8AM in the Study Eye|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and is measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.|Week 4|Intent to treat with a measurement in the study eye at Week 4|||mmHg||95% Confidence Interval|Least Squares Mean
2615240|NCT02003365|Secondary|Plasma Drug Concentrations by Time|"Plasma Drug Concentration Population. Analyses of plasma drug concentrations were performed using the Plasma Drug Concentration Population.~Values recorded as lower limit of quantification (LLOQ) (< 10 pg/mL) were counted as half the value below limit of quantification (BLQ)."|Weeks 6, 12, 16 and 20||||pg/mL||95% Confidence Interval|Geometric Mean
2615241|NCT02003365|Primary|Concentration of Triamcinolone Acetonide in Synovial Fluid|"Analyses of synovial fluid drug concentrations were performed using the Synovial Fluid Drug Concentration Population.~Values recorded as lower limit of quantification (LLOQ) (< 50 pg/mL) were counted as half the value below limit of quantification (BLQ)."|12 to 20 weeks|All patients who received study drug and had synovial fluid obtained at the Final Visit were included in the Synovial Fluid Drug Concentration Population.|||pg/mL||95% Confidence Interval|Geometric Mean
2615242|NCT02003352|Primary|Change in Diagnostic and Statistical Manual of Mental Disorders IV Clinician-Administered PTSD Scale DSM IV-(CAPS)|The CAPS is the gold standard in PTSD assessment and is a 30-item structured interview.For each symptom, standardized questions and probes are provided. Administration requires identification of an index traumatic event to serve as the basis for symptom inquiry. The full interview takes 45-60 minutes to administer.CAPS symptom severity ratings are based on symptom frequency and intensity (except for amnesia and diminished interest which are based on amount and intensity). Higher scores represent a worse outcome with severity categories of 0-19 (minimal), 20-39 (mild), 40-59 (moderate), 60-79 (severe), 80-136 (extreme). We will use changes in the DSM-IV CAPS scores before and after treatment to distinguish between the estimated frequency and intensity of the various symptoms. Frequency and intensity scores will be combined to give a total CAPS score (range: 0-136) CAPS testing was scheduled pre-intervention, 1 week post-intervention, and at 3 months post-intervention.|up to 12 weeks|Changes in CAPS scores before-after. Frequency and intensity scores combined-CAPS score (range: 0–136) . CAPS pre-intervention, 1 week post-intervention, and at 3 months post-intervention. Difference pre and post of CAPS Scores (matched pairs) two-tailed t -Test with alpha of <0.05. Effect Size Cohen's D|||units on a scale||95% Confidence Interval|Mean
2615243|NCT02003183|Primary|Distribution Volume Ratio (DVR)|The outcome measure is a ratio of the volume (in milliliters) of 2-(1-{6-[(2-fluorine 18-labeled fluoroethyl)methylamino]-2-naphthyl}ethylidene)malononitrile ([F-18]FDDNP) bound within the region of interest (ROI) divided by the amount of [F-18]FDDNP in the cerebellum (reference region). Higher ratios are indicative of higher levels of tau and amyloid proteins within the ROI. The unit of measure is called the Distribution Volume Ratio (DVR).|Baseline||||Distribution Volume Ratio (DVR)||Standard Deviation|Mean
2615244|NCT02003053|Primary|Safety and Feasibility of Inspiratory Muscle Training|The number of patients tolerating Inspiratory Muscle Training or Sham.|Baseline and until participant is extubated or discharged from the critical care unit (up to 1 month post-baseline)||||Participants|||Count of Participants
2615245|NCT02003014|Secondary|Change From Baseline Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|The change between homeostasis model assessment of insulin resistance collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. Homeostasis Model assessment of insulin resistance Measures insulin resistance, calculated by insulin times glucose, divided by a constant (22.5). A higher score indicates higher insulin resistance.|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||HOMA-IR score||Standard Deviation|Mean
2615246|NCT02003014|Secondary|Change From Baseline in Immunoreactive Insulin (IRI)|The change in the value of IRI (portion of insulin in blood measured by immunochemical methods for the hormone; presumed to represent the free [unbound] and biologically active fraction of total blood insulin) collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||micro units per milliliter (mcU/mL)||Standard Deviation|Mean
2615247|NCT02003014|Secondary|Change From Baseline in Body Weight|Change relative to baseline in participant's weight measured at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12).|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||kg||Standard Deviation|Mean
2615248|NCT02003014|Secondary|Change From Baseline in Fasting Blood Glucose|The change between the fasting blood glucose value collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2615249|NCT02003014|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.|Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2615326|NCT02002091|Primary|Number of Patients With Carotid Artery Stenosis|"Screening for carotid murmur at clinical examination by the same physician for all patients~Carotid duplex ultrasonography with intima-media thickness measurement. All atherosclerotic lesions were reported."|At recruitment|From 327, 304 patients (109 men and 195 women) could perfom duplex ultrasonography of supra aortic trunks. We focus on the examination of external and internal carotids.|||Participants|||Count of Participants
2615250|NCT02003014|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
2615251|NCT02003014|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
2615252|NCT02002975|Secondary|Association Between Patient Baseline Characteristics, Including Any Metabolic Syndrome-related Risk Factors, and Onset of New Cerebral and Cardiovascular Events||3 Years|"Outcome measure, Association between patient baseline characteristics, including any metabolic syndrome-related risk factors, and onset of new cerebral and cardiovascular events, on protocol section could not be summarized because study protocol was not defined what is the specific data for association precisely and there were no data to report."||||||
2615253|NCT02002975|Secondary|Changes From Baseline in HbA1c (NGSP) With Number of Metabolic Syndrome-related Risk Factor (MetS-related Factor) at Final Assessment Point|Changes from baseline in HbA1c (NGSP) with number of MetS-related factor were reported instead. Risk factors included Glucose Intolerance, Complication of Hypertension, Complication of Hyperlipidemia, Obesity, and Family History of Diabetes in Second-Degree Relatives.|From Baseline and final assessment point (Up to 3 Years)|Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available.|||Percent||Standard Deviation|Mean
2615254|NCT02002975|Primary|Changes From Baseline in Metabolic Syndrome Parameters (Diastolic Blood Pressure) at Final Assessment Point|Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in diastolic blood pressure as a one of metabolic syndrome parameters.|From Baseline and final assessment point (Up to 3 Years)|Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. Here number of participants analyzed are participants evaluable for this outcome measure.|||mmHg||Standard Deviation|Mean
2615255|NCT02002975|Primary|Changes From Baseline in Metabolic Syndrome Parameters (Systolic Blood Pressure) at Final Assessment Point|Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in systolic blood pressure as a one of metabolic syndrome parameters.|From Baseline and final assessment point (Up to 3 Years)|Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. Here number of participants analyzed are participants evaluable for this outcome measure.|||mmHg||Standard Deviation|Mean
2615256|NCT02002975|Primary|Changes From Baseline in Metabolic Syndrome Parameters (Fasting Triglyceride Level) at Final Assessment Point|Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in fasting triglyceride level as a one of metabolic syndrome parameters.|From Baseline and final assessment point (Up to 3 Years)|Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. Here number of participants analyzed are participants evaluable for this outcome measure.|||mg/dL||Standard Deviation|Mean
2615257|NCT02002975|Primary|Changes From Baseline in Metabolic Syndrome Parameters (High-density Lipoprotein (HDL) Cholesterol Level) at Final Assessment Point|Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in HDL cholesterol level as a one of metabolic syndrome parameters.|From Baseline and final assessment point (Up to 3 Years)|Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. Here number of participants analyzed are participants evaluable for this outcome measure.|||mg/dL||Standard Deviation|Mean
2615258|NCT02002975|Primary|Changes From Baseline in Metabolic Syndrome Parameters (Total Cholesterol Level) at Final Assessment Point|Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in total cholesterol level as a one of metabolic syndrome parameters.|From Baseline and final assessment point (Up to 3 Years)|Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. Here number of participants analyzed are participants evaluable for this outcome measure.|||mg/dL||Standard Deviation|Mean
2615259|NCT02002975|Primary|Changes From Baseline in Metabolic Syndrome Parameters (Fasting Blood Insulin Level) at Final Assessment Point|Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in fasting blood insulin level as a one of metabolic syndrome parameters.|From Baseline and final assessment point (Up to 3 Years)|Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. Here number of participants analyzed are participants evaluable for this outcome measure.|||micro unit/mL||Standard Deviation|Mean
2615260|NCT02002975|Primary|Changes From Baseline in Metabolic Syndrome Parameters (Fasting Blood Glucose) at Final Assessment Point|Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in fasting blood glucose as a one of metabolic syndrome parameters.|From Baseline and final assessment point (Up to 3 Years)|Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. Here number of participants analyzed are participants evaluable for this outcome measure.|||mg/dL||Standard Deviation|Mean
2615454|NCT02000752|Secondary|Percentage of Participants Who Reported Experiencing Pain Related to Treatment|The existence of pain related to the treatment is analyzed by the survey that the midwife carries out no more than 2 hours after the labor. A scale with 4 levels was used (no pain, mild pain, moderate pain, great pain).|Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room||||percentage|||Number
2615261|NCT02002975|Primary|Changes From Baseline in Metabolic Syndrome Parameters (Haemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)]) at Final Assessment Point|Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in HbA1c (NGSP) as a one of metabolic syndrome parameters.|From Baseline and final assessment point (Up to 3 Years)|Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available. Here number of participants analyzed are participants evaluable for this outcome measure.|||Percent||Standard Deviation|Mean
2615262|NCT02002975|Primary|Changes From Baseline in Metabolic Syndrome Parameters (Waist Circumference) at Final Assessment Point|Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in waist circumference as a one of metabolic syndrome parameters and for each gender (male/female).|From Baseline and final assessment point (Up to 3 Years)|Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available.|||cm||Standard Deviation|Mean
2615263|NCT02002975|Primary|Changes From Baseline in Metabolic Syndrome Parameters (Body Weight) at Final Assessment Point|Changes from baseline in metabolic syndrome parameters at final assessment point (up to 3 years) were reported. The reported data on this outcome measure is in body weight as a one of metabolic syndrome parameters and for each gender (male/female).|From Baseline and final assessment point (Up to 3 Years)|Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available.|||kg||Standard Deviation|Mean
2615264|NCT02002975|Primary|Percentage of Participants Who Met at Least One New Cerebral and Cardiovascular Events|Cerebral and cardiovascular events (Macroangiopathy) include the following: Sudden death, Cerebral infarction, Cerebral hemorrhage, Subarachnoid hemorrhage, Acute myocardial infarction, Angina pectoris requiring intervention or hospitalization for treatment, Cardiac failure requiring hospitalization for treatment, Atrial fibrillation, Aortic dissection. Reported data was frequency of participants who met at least one new cerebral and cardiovascular event throughout this study.|From Baseline, Up to 3 Years|Full Analysis Set included all participants who had efficacy data at baseline and post-baseline (3 Month) available.|||Percentage of Participants|||Number
2615265|NCT02002936|Secondary|Changes in Clinical Laboratory Test Results|Clinically significant changes|Up to 3 years||||participants|||Number
2615266|NCT02002936|Secondary|Overall Survival|Survived|Up to 3 years||||participants|||Number
2615267|NCT02002936|Secondary|Cytogenetic Response Ratio According to IWG 2006 Criteria|NCA (not considered assessable): no cytogenetic response|Up to 3 years||||participants|||Number
2615268|NCT02002936|Secondary|Total Efficacy in Hematologic Improvement Ratio According to IWG 2006 Criteria.|NCA (not considered assessable): no evidence of HI-E (hematologic improvement-erythroid), HI-P (hematologic improvement-platelet), HI-N (hematologic improvement-neutorophil), progressive disease, or relapse.|Up to 3 years||||participants|||Number
2615269|NCT02002936|Secondary|Total Efficacy in Hematologic Remission (IWG2006 Criteria)|"SD (stable disease): according to International Working Group 2006 response criteria for myelodysplastic syndrome, SD was defined as a failure to achieve complete remission or partial remission, but no evidence of progression for > 8 weeks."|Up to 3 years||||participants|||Number
2615270|NCT02002936|Primary|Adverse Events|Total number affected by any adverse events (details are presented in adverse event section)|Up to 3 years||||participants|||Number
2615271|NCT02002871|Other Pre-specified|Number of Participants With Acceptance of Hyperpigmentation at Week 6|"Questionaire if hyperpigmentation was acceptable if reported. Outcome was number of patients answering yes or no."|week 6|7 patients out of 20 patients reported hyperpigmentation at week 6.|||participants|||Number
2615272|NCT02002871|Other Pre-specified|Recovery of Hyperpigmentation During Follow up Period (Compared to Last Treatment)|Higher values describe a higher level of pigmentation.|week 6||||arbitrary units||Standard Deviation|Mean
2615273|NCT02002871|Other Pre-specified|Device Deficiencies|This measure describes device deficiencies in general leading to a non functional device. No specific characteristics were assessed.|over 6 weeks||||participants|||Number
2615274|NCT02002871|Other Pre-specified|Adverse Device Events (Serious and Non-serious)||over 6 weeks||||participants|||Number
2615275|NCT02002871|Other Pre-specified|Adverse Events (Serious and Non-serious)||week 0, 2, 4, 6||||participants|||Number
2615276|NCT02002871|Other Pre-specified|Hyperpigmentation - Evaluation by Mexameter|Higher values describe a higher level of pigmentation.|week 0, 2, 4, 6||||arbitrary units||Standard Deviation|Mean
2615277|NCT02002871|Secondary|Change From Week 4 (End of Treatment) of Patient Rating of Itching of the Target Area as Compared to the Control Area at End of Follow-up|patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching).|week 6||||units on a scale||Standard Deviation|Mean
2615278|NCT02002871|Secondary|Change From Baseline of Patient Rating of Itching of the Target Area as Compared to the Control Area|patients were asked to rate itching on a VAS scale (1 no itching; 100 worst imaginable itching)|week 4, 6||||units on a scale||Standard Deviation|Mean
2615279|NCT02002871|Secondary|Change From Week 4 (End of Treatment) of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area at End of Follow-up|Higher values describe a higher level of erythema.|week 6||||arbitrary units||Standard Deviation|Mean
2615280|NCT02002871|Secondary|Change From Baseline of Inflammation (Erythema) Evaluated by Mexameter of the Target Area as Compared to the Control Area|Higher values describe higher erythema levels.|week 4, 6||||arbitrary units||Standard Deviation|Mean
2615281|NCT02002871|Secondary|Change From Week 4 of the Sum Score of Local Eczema Rating as Compared to the Control Area at End of Follow-up|The investigator rated the key symptoms erythema, induration/papulation/edema, excoriation, lichenification and crusts on a score of 0-3 (none, mild, moderate, and severe) with half steps allowed. A total severity score was calculated as the sum of the single symptom ratings (range 0-15 whereas 0 (best) - 15 (worst)).|week 6||||units on a scale||Standard Deviation|Mean
2615455|NCT02000752|Primary|The Principal Outcome of the Study is the Placental Expulsion Time.|This time is measured by the midwife who is responsible of the birth, and it considers the time passed between the delivery of the newborn and the complete expulsion of the placenta.|Up to 30 minutes after the newborn delivery||||minutes||95% Confidence Interval|Mean
2615282|NCT02002871|Primary|Change From Baseline (Visit 2) of the Sum Score of Local Eczema Rating of the Target Area as Compared to the Control Area at End of Treatment|The investigator rated the key symptoms erythema, induration/papulation/edema, excoriation, lichenification and crusts on a score of 0-3 (none, mild, moderate, and severe) with half steps allowed. A total severity score was calculated as the sum of the single symptom ratings (range 0-15 whereas 0 (best) - 15 (worst)).|at week 4|Overall number of participants is also 20 because control and treated plaque were anaylsed on the same patient.|||units on a scale||Standard Deviation|Mean
2615283|NCT02002832|Secondary|Mean Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6.|"The Clinical Global Impression Scale-Improvement (CGI-I) Score is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to baseline state at the beginning of the intervention. Response is rated as one of the following, in which higher scores indicate less improvement or worsening:~1=Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5=Minimally worse, 6=Much worse, and 7=Very much worse."|From baseline to Week 6(day 42).|The primary population for the efficacy analysis was the Intent-to-Treat (ITT) population. All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.|||units on a scale||95% Confidence Interval|Least Squares Mean
2615284|NCT02002832|Primary|Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Scores.|Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 6 at the end of treatment. PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. It have 30 evaluation items, which include 7 positive sub-scale, 7 negative sub-scale and 16 general psychopathology sub-scale on a score of 1 to 7. The total score is the sum of the 30 scale items. The minimum score is 30 and the maximum score is 210. Patient with PANSS total scores＜70 is the normal,but the scores＞120 is more serious.|From baseline to Week 6(day 42).|Intent-to-Treat population: All subjects who were randomized, received at least one dose of study medication, and have a Baseline efficacy measurement and at least one post-Baseline efficacy measurement, were in the efficacy analysis in the treatment group to which they were randomized.|||units on a scale||95% Confidence Interval|Least Squares Mean
2615285|NCT02002702|Secondary|Change From Baseline in Neutrophil Gelatinase-asc Lipocalin (NGAL) Levels Through Day 14|Neutrophil gelatinase-asc lipocalin (NGAL) biomarker was used to assess the effect of serelaxin on kidney function. Geometric means of the ratio of post-Baseline values to baseline values of NGAL was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.|||Ratio||95% Confidence Interval|Geometric Mean
2615286|NCT02002702|Secondary|Change From Baseline in NT-proBNP Levels Through Day 14|NT-proBNP biomarker was used to assess the effect of serelaxinin on degree of cardiac wall stress and congestion. Geometric means of the ratio of post-Baseline values to baseline values of NT-proBNP was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.|||Ratio||95% Confidence Interval|Geometric Mean
2615287|NCT02002702|Secondary|Change From Baseline in High Sensitivity Troponin-T Levels Through Day 14|High sensitivity Troponin-T biomarker was used to assess the effect of serelaxin on myocardial damage. Geometric means of the ratio of post-Baseline values to baseline values of high sensitivity troponin-t was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.|||Ratio||95% Confidence Interval|Geometric Mean
2615288|NCT02002702|Secondary|Change From Baseline in Cystatin-C Levels Through Day 14|Cystatin-C biomarker was used to assess the effect of serelaxinin on worsening of renal function. Geometric means of the ratio of post-Baseline values to baseline values of Cystatin-C was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.|||Ratio||95% Confidence Interval|Geometric Mean
2615289|NCT02002702|Secondary|Change From Baseline in Aldosterone Levels Through Day 14|Aldosterone biomarker was used to assess the effect of serelaxinin on fluid retention. Geometric means of the ratio of post-Baseline values to baseline values of aldosterone was calculated by treatment for the full analysis set.|Baseline, Day 1, Day 2, Day 5, Day 14|The analysis was performed in the FAS population. Only participants with a value at both baseline and the post-dose time point were included.|||Ratio||95% Confidence Interval|Geometric Mean
2615290|NCT02002702|Secondary|Change From Baseline in Area Under the Curve (AUC) for Systolic Blood Pressure (SBP) Through 48 Hours of Infusion at Day 5|"The area under the curve (AUC) was defined as area under the plasma concentration-time curve from time zero to time of the last time point with measurable concentration, calculated by a trapezoidal method. Systolic blood pressure was measured using a calibrated standard sphygmomanometer after the subject remained in sitting position for 3 minutes at clinic during the visit. Sample collected at: Baseline; 30 & 60 minutes and then every hour for the first 6 hours of study drug infusion, and then every 3 hours during 48 hours of study drug infusion; every 3 hours until 12 hours following end of infusion, then every 6 hours for 48 hours and then every 24 hours until the earlier of Day 5 or discharge.~AUC for SBP is standardized by dividing by the length of respective time ranges."|Baseline, 48 hours, Day 5|The analysis was performed in the full analysis set (FAS) population, defined as all participants who were randomized in the study.|||mmHg||Standard Error|Least Squares Mean
2615291|NCT02002702|Primary|Concentration at Steady-state (Css) of Serelaxin|Concentration at steady-state (Css) was defined as concentration at the state of equilibrium obtained at the end of a certain number of administrations. Css of serelaxin in plasma was calculated by using a non-compartmental model approach.|Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)|"The analysis was performed in the PK population. Here, Number of participants analyzed signifies participants evaluable for this PK parameter at the specified time points for each arm, respectively."|||ng/mL||Standard Deviation|Mean
2615697|NCT01998399|Other Pre-specified|Time to Initiation of Unassisted Breathing|Only in patients on mechanical ventilation and assuming patient achieves 48 consecutive hours of unassisted breathing|29 days|2 participants from each arm died during this period|||hours||Full Range|Mean
2615292|NCT02002702|Primary|Weight Adjusted Clearance (CL) of Serelaxin|Weight adjusted clearance (CL) was defined as the total body clearance of serelaxin after drug administration. CL was calculated as nominal infusion rate divided by Css, using a non-compartmental model approach.|Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)|"The analysis was performed in the PK population. Here, Number of participants analyzed signifies participants evaluable for this PK parameter at the specified time points for each arm, respectively."|||mL/hr/kg||Standard Deviation|Mean
2615293|NCT02002702|Primary|Maximum Plasma Concentration (Cmax) of Serelaxin|Maximum plasma concentration (Cmax) was defined as the peak level of serelaxin, derived from plasma concentration-time data, using a non-compartmental model approach.|Baseline (pre-dose), 1, 2, 24, 48, 49, 52 and 56 hours (post-dose)|"The analysis was performed in the pharmacokinetic (PK) set, defined as all participants who received study treatment and had at least one evaluable PK parameter data. Here, Number of participants analyzed signifies participants evaluable for this PK parameter at the specified time points for each arm, respectively."|||nanogram(s)/milliliter (ng/mL)||Standard Deviation|Mean
2615294|NCT02002702|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs and SAEs, AEs Requiring Dose Adjustment or Interruption and Additional Therapy|AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards. AEs leading to discontinuations, or requiring dose adjustment or interruptions and additional therapy were assessed.|From start of study treatment up to Day 5 (for AEs); From start of study treatment up to Day 14 (for SAEs)|The analysis was performed on the safety population, defined as all participants who received at least one dose of study treatment and had at least one post-baseline assessment.|||participants|||Number
2615295|NCT02002689|Secondary|Kaplan-Meier Estimates of Progression Free Survival (PFS )Timing, Months||4 months||||months||95% Confidence Interval|Median
2615296|NCT02002689|Secondary|Summary of Timing and Estimated Rate for Progression-free Survival (PFS) - Full Analysis Set|Progression-free survival (PFS) is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause within 30 days of last dose. If a subject has not had an event, progression-free survival is censored at the date of last adequate tumor assessment.|4 months|Full Analysis set|||% progression free surviors||95% Confidence Interval|Number
2615297|NCT02002689|Primary|Summary of Overall Response (ORR) and Clinical Benefit (CBR)|Clinical benefit rate (CBR) Number and percentage of subjects with CBR (responses of CR, PR or SD ≥ 16 weeks) as assessed by investigator was reported for all patients along with 95% exact confidence interval (CI). Overall Response Rate (ORR) Overall response was to be determined by investigator assessment for each tumor in the study. For subjects with solid tumors, the assessment criteria was RECIST 1.1 and included responses of CR and/or PR. The number and percentage of subjects for different categories of overall response (e.g., for solid tumors - CR, PR, SD, PD, Not Evaluable) were to be provided for solid tumors, and each hematological tumor type (if applicable). Ninety-five percent (95%) exact CI was to be provided for the response rate(s) (e.g., for solid tumors - CRn and/or PR) as well.|16 weeks|Full analysis set|||percent responders|||Number
2615298|NCT02002650|Secondary|Moderate-to-severe Pancreatitis|Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery).|30 days||||participants|||Number
2615299|NCT02002650|Primary|Post-ERCP Pancreatitis|Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights.|30 days||||participants|||Number
2615300|NCT02002533|Secondary|Change in Mean Circadian Rhythm Acrophase Over 12 Hours|Activity levels were measured using an actigraphy device worn as a watch. The data was collected by the device for a 24 hour period. A model consisting of two cosine functions, one with a period of 12 hours, and the other with a period of 24 hours is fit to log activity counts as the dependent variable, and hour (0 to 24) as the independent variable. The acrophase is the time where peak activity occurs over a 12 hour period. The larger the acrophase the later in the day is the peak activity.|baseline to up to 1 month|Based on subjects that completed study through post-intervention.|||hours||Standard Deviation|Mean
2615301|NCT02002533|Secondary|Change in Mean Circadian Rhythm Acrophase Over 24 Hours|Activity levels were measured using an actigraphy device worn as a watch. The data was collected by the device for a 24 hour period. A model consisting of two cosine functions, one with a period of 12 hours, and the other with a period of 24 hours is fit to log activity counts as the dependent variable, and hour (0 to 24) as the independent variable. The acrophase is the time where peak activity occurs over a 24 hour period. The larger the acrophase the later in the day is the peak activity.|baseline to up to 1 month|Based on subjects that completed study through post-intervention.|||hours||Standard Deviation|Mean
2615302|NCT02002533|Secondary|Change in Circadian Rhythm Amplitude Over 12 Hours|Activity levels were measured using an actigraphy device worn as a watch. The data was collected by the device for a 24 hour period. A model consisting of two cosine functions, one with a period of 12 hours, and the other with a period of 24 hours is fit to log activity counts as the dependent variable, and hour (0 to 24) as the independent variable. The amplitude is the highest activity level over a 12 hour period.|baseline to up to 1 month|Based on subjects that completed study through post-intervention.|||log10 (counts/minute)||Standard Deviation|Mean
2615303|NCT02002533|Secondary|Change in Circadian Rhythm Amplitude Over 24 Hours|Activity levels were measured using an actigraphy device worn as a watch. The data was collected by the device for a 24 hour period. A model consisting of two cosine functions, one with a period of 12 hours, and the other with a period of 24 hours is fit to log activity counts as the dependent variable, and hour (0 to 24) as the independent variable. The ampliitude is the peak activity level over a 24 hour period.|baseline to up to 1 month|Based on subjects that completed study through post-intervention.|||log10 (counts/minute)||Standard Deviation|Mean
2615304|NCT02002533|Secondary|Change in Mean Circadian Rhythm Mesor|Activity levels were measured using an actigraphy device worn as a watch. The data was collected by the device for a 24 hour period. A model consisting of two cosine functions, one with a period of 12 hours, and the other with a period of 24 hours is fit to log activity counts as the dependent variable, and hour (0 to 24) as the independent variable. The mesor is the average activity over a 24 hour period.|Baseline to up to 1 month|Based on subjects that completed study through post-intervention.|||log activity counts||Standard Deviation|Mean
2615305|NCT02002533|Secondary|Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)|Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. The difference between arms will be assessed using ANCOVA. The response will be the post-intervention outcome. Arm will be the factor, and baseline will be the covariate. Appropriate contrasts will be used to estimate the difference between arms in change from baseline. Initially, the arm*baseline interaction will be assessed with an F test. If this interaction is insignificant at the 0.05 level, it will be dropped from the final model. If the interaction is significant, then mean change from baseline at various levels of baseline will be reported.|Baseline to up to 1 month|Based on subjects that completed study through post-intervention.|||units on a scale||Standard Deviation|Mean
2615306|NCT02002533|Secondary|Change in Insomnia as Measured by the Insomnia Severity Index (ISI)|"The ISI has seven questions. The seven answers are added up to get a total score.~Total score categories:~0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe) The difference between arms will be assessed using analysis of covariance (ANCOVA). The response will be the post-intervention outcome. Arm will be the factor, and baseline will be the covariate. Appropriate contrasts will be used to estimate the difference between arms in change from baseline. Initially, the arm*baseline interaction will be assessed with an F test. If this interaction is insignificant at the 0.05 level, it will be dropped from the final model. If the interaction is significant, then mean change from baseline at various levels of baseline will be reported."|Baseline to up to 1 month|Based on subjects that completed study through post-intervention.|||units on a scale||Standard Deviation|Mean
2615307|NCT02002533|Primary|Percentage of Key Components of BBT Delivered by NCI Community Oncology Research Program (NCORP) Staff, Assessed by Checklist and Auditing of Audio-recordings|Each NCORP staff person completed a study checklist in which they designated which concepts they discussed with the patient at each session. Concepts included how sleep problems develped, how to control stimulus, and sleeping environment. The overall mean percent delivery was measured using a random effects model (residual maximum likelihood [REML] estimation), where the intercept represents the mean delivery and three independent random effects are included. Because of the small sample size, testing will use the Kenward-Roger procedure.|Up to 1 month|This assessment was only performed for the BBT arm.|||percentage of components delivered||Standard Error|Mean
2615308|NCT02002533|Primary|Percentage of Consented Participants Who Complete the Study, Defined as Completion of at Least 5 BBT|Will be evaluated by calculating the specific percentage (with 95% confidence interval) and performing an exact binomial test with the null hypothesis being greater than or equal to 75%.|Up to 1 month|Data on HEAL subjects was not collected since the main focus was BBT, therefore only rate of adherence is shown for BBT group.|||percentage of participants||95% Confidence Interval|Number
2615309|NCT02002533|Primary|Percentage of Eligible Patients Consented|Will be evaluated by calculating the specific percentage (with 95% confidence interval) of the total number of participants approached that then consented and enrolled in the study.|baseline|92 people were approached to enroll in the study|||percentage of participants||95% Confidence Interval|Number
2615310|NCT02002221|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|The occurrence of adverse events was sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, vital sign, or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|12 weeks|The safety set consisted of all patients who received at least one dose of study medication.|||Participants|||Number
2615311|NCT02002221|Secondary|Number of Participants With Incidence of Hypoglycemia and Severe Hypoglycemia|Hypoglycemic events are defined as a) symptoms suggestive of hypoglycemia, where the patient is able to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 1), b) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and plasma glucose measurement is < 56 mg/dL (grade 2), c) symptoms suggestive of hypoglycemia, where the patient is unable to initiate self-treatment and no plasma glucose measurement is available (suspected grade 2)|12 weeks|The safety set consisted of all patients who received at least one dose of study medication.|||Participants|||Number
2615312|NCT02002221|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 12 Weeks|FPG was performed on a blood sample obtained and analyzed at a central laboratory.|Baseline, week 12|The full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-baseline assessment of efficacy parameter measurement. Number of patients with observations at both baseline and endpoint are analyzed in this endpoint.|||mg/dL||Standard Error|Least Squares Mean
2615313|NCT02002221|Secondary|Percentage of Patients Meeting Responder Rates in HbA1c|Responder rate was analyzed in categories: Criterion 1- Endpoint HbA1c ≤ 6.5%, Criterion 2- Endpoint HbA1c < 7% , Criterion 3- Endpoint HbA1c < 7% in patients with baseline HbA1c ≤ 8%, Criterion 4- HbA1c reduction from baseline at endpoint ≥ 1%, Criterion 5- HbA1c reduction from baseline at endpoint ≥ 0.5%. The number of patients analyzed for Criterion 1 and 2 include only patients with baseline HbA1c ≥ 7% (> 6.5%) and endpoint HbA1c measurement. The number of patients analyzed for Criterion 3 includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c measurement. The number of patients analyzed for Criterion 4 and 5 include patients with both baseline and endpoint HbA1c measurements.|Baseline, week 12|The full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-baseline assessment of efficacy parameter measurement.|||percentage of patients|||Number
2615314|NCT02002221|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks Between Treatment Groups|HbA1c was performed on a blood sample obtained and measured by high performance liquid chromatography performed at a central laboratory.|Baseline, week 12|The full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-baseline assessment of efficacy parameter measurement.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
2615315|NCT02002208|Secondary|Rate of Flares||over 16 weeks||||flares||Standard Deviation|Mean
2615316|NCT02002208|Primary|Change From Baseline in Eczema Area and Severity Index (EASI) Compared to Placebo at Week 16|The EASI scoring system uses a defined process to grade the severity of the signs of eczema and the extent affected in four regions of the body: head and neck, trunk, upper extremities and lower extremities. The scale ranges from 0 to 72 and the severity strata for the EASI are as follows: 0 clear; 0.1-1.0 almost clear; 1.1-7.0 mild; 7.1-21.0 =moderate; 21.1-50.0 severe; 50.1-72.0 very severe. When assessing response to therapy a reduction of 7 or more is considered to be clinically meaningful.|EASI was measured at baseline (week 0) and 16 weeks after dosing.|Adjusted mean change from baseline EASI at Week 16|||units on a scale||Standard Error|Mean
2615317|NCT02002091|Secondary|Number of Patients That Died From Cardio Vascular Cause|- We recorded each death and its cause from a medical record after hospitalization in emergency units or phone contact with the patient's relatives to have some news. The record began with recruitment.|One year after recruitment|From 327 patients (122 men and 205 women) enrolled, 305 were followed-up one year or until death (112 men and 193 women). 22 patients (10 men and 12 women) were excluded from analysis because lost during follow-up.|||Participants|||Count of Participants
2615318|NCT02002091|Secondary|Number of Patients With Lower Limbs Atherothrombotic Accident|"During one year of follow-up :~We search for a recent history of intermittent claudication;~We perform a systematic clinical examination with palpation of lower limb pulses and an Ankle-Brachial Index measurement after one year or in the presence of an acute ischemic lower limb episod ;~Lower limb duplex sonography in the presence of an abnormal clinical vascular examination;~Angiography in the presence of a lower limbs vascular event."|One year after recruitment|300 patients (109 men and 191 women) were re-evaluated one year after recruitment. From 327 patients enrolled, we excluded 27 patients (13 men and 14 women) from the analysis because of a lack of data, 22 patients (10 men and 12 women) were lost from follow-up and 5 died too early during follow-up (three first months).|||Participants|||Count of Participants
2615319|NCT02002091|Secondary|Number of Patients With New Stroke or Transient Ischemic Attack|"We assessed every new clinical signs of stroke with an interview searching for acute neurological symptoms and a clinical examination for all patients, from day one of recruitment to one year of follow-up;~Tomodensitometry if there was a clinical presentation of stroke. Magnetic resonance imaging if transient ischemic attack was suspected."|One year after recruitment|300 patients (109 men and 191 women) were re-evaluated one year after recruitment. From 327 patients enrolled, we excluded 27 patients (13 men and 14 women) from the analysis because of a lack of data. 22 patients (10 men and 12 women) were lost from follow-up and 5 died too early during follow-up (three first months).|||Participants|||Count of Participants
2615320|NCT02002091|Secondary|Number of Patients With New Cardiac Events During Follow-up|"We Record every documented acute coronary syndrome during follow-up;~Each patient had an electrocardiogram every 3 months and during acute cardiovascular events;~Echocardiography has been performed if indicated by the cardiologist."|One year after recruitment|305 patients (112 men and 193 women) were re-evaluated one year after recruitment. From 327 patients enrolled, we excluded 22 patients (10 men and 12 women) from the analysis because of a lack of data, they were lost from follow-up. We include in analysis 5 patients who died the three first months during follow-up.|||Participants|||Count of Participants
2615321|NCT02002091|Primary|Number of Patients With Erectile Dysfunction|- Questionary: onset , drug use, medical history, psycho- social conditions|at recruitment||||Participants|||Count of Participants
2615322|NCT02002091|Primary|Number of Patients With Gastro-intestinal Autonomic Neuropathy|"We interviewed all patient, looking for a history of post prandial discomfort or bad gastric emptying sensation or vomiting or unexplained diarrhea or constipation~We performed an endoscopic examination to exclude other causes in patients with a positive history of gastro-intestinal troubles."|at recruitment|An endoscopic examination has been performed in six women whose report vomiting, nausea or constipation. In the men's group no-one had an endoscopic examination.|||Participants|||Count of Participants
2615323|NCT02002091|Primary|Number of Patients With Bladder Autonomic Neuropathy|"History of recurrent urine tract infection and/or dysuria and/or incomplete bladder emptying~Post voiding residual(PVR) measurement with abdominal echography by a radiologist~Cystomanometry is performed if PVR > 50 ml~In men the prostatic measurement was made in all patients. In women, we measured the volume of uterus."|at recruitment|From 327 we could screen 318 patients (118 men and 200 women) for bladder autonomic neuropathy. We performed a cystomanometry in 4 patients. We exclude, from analysis, 9 patients who didn't come to perform the post-voiding volume measurement.|||Participants|||Count of Participants
2615324|NCT02002091|Primary|Number of Patients With Cardiac Autonomic Neuropathy|"Conditions of the Ewing tests: fasting, resting at least 30mn, no hypoglycemia and no effort within 24hours, no drugs that interfere with heart rate.~Ewing Tests for cardiac autonomic neuropathy: Beat-to-Beat heart rate variation, Heart rate response to standing, Heart rate response to valsalva maneuver, Systolic blood pressure response to standing. All tests have been performed with the same physician and aid"|at recruitment|We screened 283 patients from 327 (100 men and 183 women). We excluded 44 patients from analysis (22 men and 22 women)cause of beta blocker treatment or high blood pressure, or diabetic retinopathy, or severe coronary heart disease and patients that could not perform deep breathing.|||Participants|||Count of Participants
2615325|NCT02002091|Primary|Number of Patients With Renal Artery Stenosis or Elevated Intrarenal Resistance Index|- Renal artery duplex ultrasonography has been performed only if the patient presents a resistant hypertension treated with four drugs, including a diuretic or if blood pressure was over 180/10 mm Hg at recruitement.|At recruitment|From 327 we perform a duplex ultrasonography of renal arteries in 16 patients (6 men and 10 women) The number of participants analyzed is too small to have a statistical analysis.|||Participants|||Count of Participants
2615698|NCT01998399|Secondary|Myocardial Infarction|Did the patient have a myocardial infarction during the 90 day study?|90 days||||Participants|||Count of Participants
2615327|NCT02002091|Primary|Number of Patients With Lower Extremity Artery Disease|"Search for history of intermittent claudication~Complete vascular examination with Ankle-Brachial Index (ABI) measurement.~Lower limb duplex ultrasonography."|At recruitment|Lower limb duplex ultrasonography measurement has been done in 306 among 327 patients (111 men and 195 women). 21 patients, with a lack of data,were excluded from analysis. Chi 2 test was used for comparison of proportions.|||Participants|||Count of Participants
2615328|NCT02002091|Primary|Number of Patients With Silent Myocardial Ischemia|"9 derivations resting electrocardiogram (ECG)~Echocardiography~Standard ECG stress test~Stress Myocardial Perfusion scintigraphy if patients are not able to perform ECG stress test~Coronary angiography if the exercise ECG stress test or stress myocardial perfusion scintigraphy suggest high probability of coronary heart disease"|At recruitment|88.9 % (291 patients) had a screening for coronary heart disease. We performed an electrocardiogram in 325 cases, an echocardiography in 317 cases, a myocardial ischemic test in 291 cases (223 for silent myocardial ischemia: 85 men and 138 women) and a coronarography in 18 cases ( 8 men and 10 women, all had a positive myocardial ischemic test)|||Participants|||Count of Participants
2615329|NCT02002091|Primary|Number of Patients With Hypertension|"Blood pressure measurement by electronic tensiometer (OMRON 3 or 4) on the right and left arm, after 10 mn of supine position.~Three measures were performed with respect of one minute interval between each measure.~Mean blood pressure is calculated~Three other measures are performed in Three ulterior consultations~Hypertension is diagnosed if the mean blood pressure >= 140 /90 mm Hg"|At recruitment||||Participants|||Count of Participants
2615330|NCT02002091|Primary|Number of Patients With Chronic Kidney Disease (CKD)|"We screened for albuminuria or microalbuminuria in 24h urine collection with turbidimetry or immuno turbidimetry method ( performed 3 times in 4 or 6 months )~Measurement of albumine- to- creatinine ratio (ACR), Albuminuria was diagnosed if ACR > or egal to 30 mg/g at least twice in 4 to 6 months. We ensure before performing ACR that there was no dysglycaemia, no urinary infection, no fever nor forced diuresis before we evaluate the urine sample.~Cyto bacteriological examination and urine culture~Serum creatinine repeated 2 to 3 time within 4 to 6 months~Glomerular filtration rate was assessed with the Modification of Diet in Renal disease study equation (MDRD)~Renal and urine tract echography to measure the kidneys and to screen for urine tract dilatation We made the diagnosis of Chronic Kidney Disease (CKD) if the glomerular filtration rate was < 60 ml/min/1.73 m² and/or ACR > or equal to 30 mg/g with a permanent character"|At recruitment|Of 327 patients, 317 had a complete screening for chronic kidney disease, 5 men and 5 women were excluded from analysis because of incomplete renal status.|||Participants|||Count of Participants
2615331|NCT02002091|Primary|Number of Patients With Distal Diabetic Neuropathy|"All 327 patients had a neurological examination by the same physician to screen for Distal Diabetic Neuropathy:~Distal sensory testing: including 10 g monofilament test, vibration perception with 128 Hz tuning fork, temperature, touch , prickling and pain perception~Ankles and knees reflex testing~Muscle strength testing (quadriceps and tibialis anterior)~We use the Michigan Neuropathy Screening Instrument score. We consider the diagnosis of Distal Diabetic Neuropathy if the score is up of 2 in at least one food. The MNSI score is ranged from 0 to 5 for each food~Use of neuropathic pain score (DN4), if the DN4 is found up or egal to 4 we consider the diagnosis of neuropathic pain. The DN4 score is ranged from 0 to 10"|At recruitment|We exclude from analysis 10 patients (2 men and 8 women) with neuropathy because of other possible etiology (8 hypothyroidism, 1 with B12 deficiency,1 with narrowed lumbar vertebra channel)|||Participants|||Count of Participants
2615332|NCT02002091|Primary|Number and Prevalence of Patients With Diabetic Retinopathy|"Conventional ophtalmoscopy has been used to screen for diabetic retinopathy by an ophtalmologist at his office.~Retinal angiography was performed if indicated by the ophtalmologist"|At recruitment|From 327, 309 (113 men and 196 women) patients benefit from ophthalmoscopy with a trained ophthalmologist. 18 patients (9 men and 9 women) didn't perform the test. Each patient having a diabetic retinopathy was treated by the ophtalmologist who performed the examination|||Participants|||Count of Participants
2615333|NCT02001987|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies to Tocilizumab|Percentage of participants with a positive response to anti-therapeutic antibodies against tocilizumab by confirmatory assays at any time during the study is reported.|Baseline up to 8 weeks after last study drug administration (up to Week 84)|FAS|||percentage of participants|||Number
2615334|NCT02001987|Secondary|Change From Baseline in Synovitis Ultrasound Power-Doppler Mode Score at Week 24|"Synovitis was assessed by ultrasonographic evaluation (Power-Doppler-mode ultrasound) and scored from 0 to 3 for each 7 paired joints (wrists on both sides, 2nd and 3rd metacarpo-phalangeal [MCP 2/3] on both sides, 2nd and 3rd proximal inter-phalangeal [PIP 2/3] on both sides, 2nd and 5th metatarsophalangeal [MTP 2/5] on both sides). Synovitis total score was calculated by adding the sum of scores for each joint for a total score ranging from 0 to 42. A score of 0 indicated no damage and a score of 42 indicated most severe damage. The changes from Baseline to any time point were averaged among all participants, where negative changes indicated better outcome."|Baseline, Weeks 24|FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified categories.|||units on a scale||Full Range|Median
2615335|NCT02001987|Secondary|Change From Baseline in Synovitis Ultrasound B-Mode Score at Week 24|"Synovitis was assessed by ultrasonographic evaluation (B-mode ultrasound) and scored from 0 to 3 for each 7 paired joints (wrists on both sides, 2nd and 3rd metacarpo-phalangeal [MCP 2/3] on both sides, 2nd and 3rd proximal inter-phalangeal [PIP 2/3] on both sides, 2nd and 5th metatarsophalangeal [MTP 2/5] on both sides). Synovitis total score was calculated by adding the sum of scores for each joint for a total score ranging from 0 to 42. A score of 0 indicated no damage and a score of 42 indicated most severe damage. The changes from Baseline to any time point were averaged among all participants, where negative changes indicated better outcome."|Baseline, Weeks 24|FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified categories.|||units on a scale||Full Range|Median
2615453|NCT02000752|Secondary|Percentage of Mothers That Would Recommend the Technique to Any of Her Friends|"The number of mothers that would recommend the technique to any of her friends is analyzed in the survey that the midwife carries out no more than 2 hours after the labor. The possible responses are I would recommend it, or I would not recommend it."|Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room||||percentage|||Number
2615336|NCT02001987|Secondary|Number of Participants According to Reasons for Changes in csDMARDs Treatment During Study|Number of participants according to reasons for changes in csDMARDs treatment during study is reported. The changes included Increase of dose (the dose increase had to be greater than the highest dose received within the 4 weeks on or before baseline); Addition of another csDMARD (without suppression of the first one); Switch (add and suppression) of a csDMARD for another reason than intolerance to the csDMARD suppressed; Modification of the administration route of MTX (with increase or maintenance of the dose): per oral route to IV/IM/SC. Participants with a change in csDMARDs treatment during entire study were only included in the analysis.|Screening up to 8 weeks after last dose (overall up to 88 weeks)|LTE population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||Participants|||Count of Participants
2615337|NCT02001987|Secondary|Number of Participants According to Reasons for Changes in csDMARDs Treatment During Core Study Period|Number of participants according to reasons for changes in csDMARDs treatment during core study period is reported. The changes included Increase of dose (the dose increase had to be greater than the highest dose received within the 4 weeks on or before baseline); Addition of another csDMARD (without suppression of the first one); Switch (add and suppression) of a csDMARD for another reason than intolerance to the csDMARD suppressed; Modification of the administration route of MTX (with increase or maintenance of the dose): per oral route to intravenous (IV)/ intramuscular (IM)/ SC. Participants with a change in csDMARDs treatment during core study period were only included in the analysis.|Screening up to 8 weeks after last dose in core study period (overall up to 36 weeks)|FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||Participants|||Count of Participants
2615338|NCT02001987|Secondary|Number of Participants According to Reasons for Change in Corticosteroid Dosage During Study|Number of participants according to reasons for a change in corticosteroid dosage during study compared to Baseline is reported. The change included either an initiation/ increase (>+5mg/day prednisone or equivalent) of corticosteroid dosage or a decrease (</=-5mg/day prednisone or equivalent) of corticosteroid dosage. Participants with a change in corticosteroid dosage during entire study were only included in the analysis.|Screening up to 8 weeks after last dose (overall up to 88 weeks)|LTE population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified categories.|||Participants|||Count of Participants
2615339|NCT02001987|Secondary|Time to Change in Corticosteroid Dosage During Study|Time to first change in corticosteroid dosage during study compared to Baseline is reported. The change included either an initiation/ increase (>+5mg/day prednisone or equivalent) of corticosteroid dosage or a decrease (</=-5mg/day prednisone or equivalent) of corticosteroid dosage. Participants with a change in corticosteroid dosage during entire study were only included in the analysis.|Screening up to 8 weeks after last dose (overall up to 88 weeks)|LTE population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified categories.|||days||Full Range|Median
2615340|NCT02001987|Secondary|Percentage of Participants With Change in Corticosteroid Dosage During Study|Percentage of participants with a change in corticosteroid dosage during study compared to Baseline is reported. The change included either an initiation/ increase (>+5mg/day prednisone or equivalent) of corticosteroid dosage or a decrease (</=-5mg/day prednisone or equivalent) of corticosteroid dosage.|Screening up to 8 weeks after last dose (overall up to 88 weeks)|LTE population|||percentage of participants|||Number
2615341|NCT02001987|Secondary|Time to First Temporary Discontinuation of Corticosteroid Dosage During Study|Time to first temporary discontinuation in corticosteroid dosage during study is reported. Participants who temporarily discontinued corticosteroids at any time during entire study were only included in the analysis.|Screening up to 8 weeks after last dose (overall up to 88 weeks)|LTE population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||days||Full Range|Median
2615342|NCT02001987|Secondary|Time to Permanent Discontinuation of Corticosteroid Dosage During Study|Time to permanent discontinuation in corticosteroid dosage during study is reported. Participants who permanently discontinued corticosteroids at any time during entire study were only included in the analysis.|Screening up to 8 weeks after last dose (overall up to 88 weeks)|LTE population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||days||Full Range|Median
2615343|NCT02001987|Secondary|Percentage of Participants With Discontinuations of Corticosteroid Dosage During Study|Percentage of participants with a discontinuation in corticosteroid dosage during study is reported. The discontinuations were categorized as either permanent or temporary. Participants with temporary discontinuation first followed by permanent discontinuation were counted in both categories. Participants who were receiving corticosteroids at Baseline were only included in the analysis.|Screening up to 8 weeks after last dose (overall up to 88 weeks)|LTE population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||percentage of participants|||Number
2615344|NCT02001987|Secondary|Number of Participants According to Reasons for Change in Corticosteroid Dosage During Core Study Period|Number of participants according to reasons for a change in corticosteroid dosage during core study period compared to Baseline is reported. The change included either an initiation/ increase (>+5mg/day prednisone or equivalent) of corticosteroid dosage or a decrease (</=-5mg/day prednisone or equivalent) of corticosteroid dosage. Participants with a change in corticosteroid dosage during core study period were only included in the analysis.|Screening up to 8 weeks after last dose in core study period (overall up to 36 weeks)|FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified categories for different arms, respectively.|||Participants|||Count of Participants
2615400|NCT02001558|Primary|Pressure Ulcer Size (Length x Width x Depth, cm^3) at 20 Weeks After Baseline|Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.|20 weeks after baseline|"Microcyn arm: there were 12 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 25 participants lost to follow up during this evaluation period."|||cm^3||Full Range|Median
2615345|NCT02001987|Secondary|Time to Change in Corticosteroid Dosage During Core Study Period|Time to first change in corticosteroid dosage during core study period compared to Baseline is reported. The change included either an initiation/ increase (>+5mg/day prednisone or equivalent) of corticosteroid dosage or a decrease (</=-5mg/day prednisone or equivalent) of corticosteroid dosage. Participants with a change in corticosteroid dosage during core study period were only included in the analysis.|Screening up to 8 weeks after last dose in core study period (overall up to 36 weeks)|FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified categories for different arms, respectively.|||days||Full Range|Median
2615346|NCT02001987|Secondary|Percentage of Participants With Change in Corticosteroid Dosage During Core Study Period|Percentage of participants with a change in corticosteroid dosage during core study period compared to Baseline is reported. The change included either an initiation/ increase (>+5mg/day prednisone or equivalent) of corticosteroid dosage or a decrease (</=-5mg/day prednisone or equivalent) of corticosteroid dosage.|Screening up to 8 weeks after last dose in core study period (overall up to 36 weeks)|FAS|||percentage of participants|||Number
2615347|NCT02001987|Secondary|Time to First Temporary Discontinuation of Corticosteroid Dosage During Core Study Period|Time to first temporary discontinuation in corticosteroid dosage during core study period is reported. Participants who temporarily discontinued corticosteroids at any time during core study period were only included in the analysis.|Screening up to 8 weeks after last dose in core study period (overall up to 36 weeks)|FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||days||Full Range|Median
2615348|NCT02001987|Secondary|Time to Permanent Discontinuation of Corticosteroid Dosage During Core Study Period|Time to permanent discontinuation in corticosteroid dosage during core study period is reported. Participants who permanently discontinued corticosteroids at any time during core study period were only included in the analysis.|Screening up to 8 weeks after last dose in core study period (overall up to 36 weeks)|FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||days||Full Range|Median
2615349|NCT02001987|Secondary|Percentage of Participants With Discontinuations of Corticosteroid Dosage During Core Study Period|Percentage of participants with a discontinuation in corticosteroid dosage during core study period is reported. The discontinuations were categorized as either permanent or temporary. Participants with temporary discontinuation first followed by permanent discontinuation were counted in both categories. Participants who were receiving corticosteroids at Baseline were only included in the analysis.|Screening up to 8 weeks after last dose in core study period (overall up to 36 weeks)|FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||percentage of participants|||Number
2615350|NCT02001987|Secondary|Change From Baseline in BioSecure Questionnaire Score at Week 24|The BioSecure questionnaire comprised of 54-item aimed at evaluating the safety competences of participants (for example, participants' self-care safety skills and socio-demographic characteristics, type of information received, quality of life, and coping style data) treated by biologics for inflammatory arthritis and to determine the factors associated with a lower level of competences.|Baseline, Week 24|QoL population was planned to be included in the analysis. Data for this outcome measure could not be analyzed due to unavailability of the methodology to calculate the BioSecure global score and sub-scores.||||||
2615351|NCT02001987|Secondary|Change From Baseline in Fluctuations of Disease Activity in Rheumatoid Arthritis (FLARE) Questionnaire Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 40, 52, and 64|FLARE is a 13-item questionnaire assessed disease flares between two medical consultations. Each item score ranged from 0 (completely untrue) to 10 (absolutely true) on a 6-step scale. The FLARE questionnaire global score (range = 0-10) is a mean score of 11 of the 13 items [items 6 ('doses of pain killers or anti-inflammatory medication') and 13 ('need for help') not taken into account], with the highest score corresponding to the highest disease activity. The global score was computed if at least the scores of 6 items were available. The changes from Baseline to any time point were averaged among all participants, where negative changes indicated better outcome.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 40, 52, and 64|QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
2615352|NCT02001987|Secondary|Change From Baseline in Medical Outcome Study (MOS) Sleep Questionnaire Score at Weeks 12, 24, 28, 40, 52, and 64|MOS sleep scale comprised of 6-item with each item score ranged from 0 to 100. The total score was the average of scores sum (range 0-100), with highest values reflecting biggest participant's sleeping problems. If more than 3 items were missing the index was not calculated. The changes from Baseline to any time point were averaged among all participants, where negative changes indicated better outcome.|Baseline, Weeks 12, 24, 28, 40, 52, and 64|QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
2615353|NCT02001987|Secondary|Change From Baseline in Bristol Rheumatoid Arthritis Fatigue (BRAF)-NRS Score at Weeks 24 and 52|BRAF-NRS are 3 standardized NRS (range = 0-10) for disease related fatigue domains (severity of fatigue, fatigue effect, and coping with fatigue). Higher values reflect greater problems for severity/level fatigue and effect fatigue NRS, but lower scores reflect greater problems for copped fatigue NRS.|Baseline, Weeks 24 and 52|QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
2615362|NCT02001987|Secondary|Change From Baseline in Pain VAS Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64|Participant-assessed pain was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of pain (0 mm=none; 100 mm=very severe). The change from Baseline to any time point was averaged among all participants, where negative change indicated a decrease in participant-assessed pain.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64|QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.|||mm||Standard Deviation|Mean
2615354|NCT02001987|Secondary|Change From Baseline in Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ) Total Score at Weeks 24 and 52|BRAF-MDQ assessed the overall experience and impact of disease related fatigue, using four dimensions (physical fatigue [4 items], living with fatigue [7 items], cognitive fatigue [5 items], and emotional fatigue [4 items]). A total fatigue score (range 0 to 70) was obtained by summing the 20 item scores ranging from 0 to 3, except for item 1 (0-10), item 2 (0-7) and item 3 (0-2). Higher scores reflect greater fatigue. If only 1 domain was missing it was replaced by the mean of the others; otherwise, the total score was not calculated. The changes from Baseline to any time point were averaged among all participants, where negative changes indicated better quality of life.|Baseline, Weeks 24 and 52|QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
2615355|NCT02001987|Secondary|Number of Participants With Patient Acceptable Symptom State (PASS) Score|"Participants were asked: If you were to remain in the same condition for the next few months as you have been over the last 8 days, would this be 1) acceptable, 2) Inacceptable? The number of participants who responded acceptable or Inacceptable at each time point is presented."|Baseline, Weeks 24, 52, and last assessment (up to Week 76)|QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.|||Participants|||Count of Participants
2615356|NCT02001987|Secondary|Change From Baseline in Routine Assessment of Patient Index Data 3 (RAPID-3) at Weeks 2, 4, 12, 24, 28, 40, 52, and 64|RAPID-3 is a combined index derived from the Multidimensional Health Assessment Questionnaire that includes physical function score, pain VAS, and PGA VAS. The total RAPID-3 score ranges from 0 to 10 where higher scores represent worse outcomes. The changes from Baseline to any time point were averaged among all participants, where negative changes indicated better outcome.|Baseline, Weeks 2, 4, 12, 24, 28, 40, 52, and 64|QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
2615357|NCT02001987|Secondary|Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score at Weeks 12, 24, 28, 40, 52, and 64|RAID assessed the impact of rheumatoid arthritis on participant's quality of life. It comprised 7 domains: pain, function, fatigue, physical and psychological well-being, sleep disturbance and coping. Each domain was a single question scored from 0 (best) to 10 (worst) on a continuous numerical rating scale (NRS). Each domain also had a specific weight assigned by a participant survey and RAID total score ranged from 0 (best) to 10 (worst). If only 1 domain was missing it was replaced by the mean of the others; otherwise, RAID score was not calculated. The changes from Baseline to any time point were averaged among all participants, where negative changes indicated better quality of life.|Baseline, Weeks 12, 24, 28, 40, 52, and 64|QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
2615358|NCT02001987|Secondary|Treatment Compliance From Baseline up to Week 24|Treatment compliance from Baseline up to Week 24 was assessed using following formula: (number of actual injection received / number of theoretical injection which should be received at week 24) * 100.|Baseline up to Week 24|FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||percentage of injections||Standard Deviation|Mean
2615359|NCT02001987|Secondary|Percentage of Participants With HAQ-DI Clinically Meaningful Improvement at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64|HAQ-DI assessed 20 items in 8 functional activity domains including dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item was scored on a scale of 0 to 3, where 0 represented activities performed without difficulty and 3 represented inability to perform activities alone. The total score (range = 0-3) was calculated as an average of all item scores. Percentage of participants with HAQ-DI clinically meaningful improvement (reduction in HAQ-DI score from baseline >/=0.22) at each time point is reported.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64|QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.|||percentage of participants|||Number
2615360|NCT02001987|Secondary|Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Remission at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64|HAQ-DI assessed 20 items in 8 functional activity domains including dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item was scored on a scale of 0 to 3, where 0 represented activities performed without difficulty and 3 represented inability to perform activities alone. The total score (range = 0-3) was calculated as an average of all item scores. Percentage of participants with HAQ-DI remission (HAQ-DI score <0.5) at each time point is reported.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64|QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.|||percentage of participants|||Number
2615361|NCT02001987|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated questions), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). The changes from Baseline to any time point were averaged among all participants, where negative changes indicated an increase in fatigue.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64|QoL population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
2615363|NCT02001987|Secondary|Change From Baseline in PGA at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64|Participant-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of disease activity (0 mm=none; 100 mm=very severe). The change from Baseline to any time point was averaged among all participants, where negative change indicated a decrease in participant-assessed disease activity.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, and 64|Quality of Life (QoL) population included all enrolled participants with at least one electronic patient-reported outcome (ePRO) questionnaire completed. Here, 'Overall Number of Participants Analyzed' = number of participants evaluable for this outcome measure and 'Number Analyzed' = number of participants evaluable at specified time points.|||mm||Standard Deviation|Mean
2615364|NCT02001987|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 2, 4, 8, 12, 16, 20, and 24|Physician-assessed disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's evaluation of disease activity (0 mm=none; 100 mm=very severe). The change from Baseline to any time point was averaged among all participants, where negative change indicated a decrease in physician-assessed disease activity.|Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24|FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points. In case of missing value at Week 24, LOCF method was applied.|||mm||Standard Deviation|Mean
2615365|NCT02001987|Secondary|Change From Baseline in TJC at Week 24 and at Last Assessment|A total of 28 joints were assessed for tenderness. The number of tender joints at could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to any time points was averaged among all participants, where negative changes indicated an improvement in disease activity.|Baseline, Week 24, last assessment (up to Week 76)|LTE population; In case of missing value at Week 24, LOCF method was applied.|||tender joints||Full Range|Median
2615366|NCT02001987|Secondary|Change From Baseline in TJC at Weeks 2, 4, 8, 12, 16, 20, and 24|A total of 28 joints were assessed for tenderness. The number of tender joints at could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to any time points was averaged among all participants, where negative changes indicated an improvement in disease activity.|Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24|FAS; Here, 'Number Analyzed' signifies number of participants evaluable at specified time points for different arms, respectively. In case of missing value at Week 24, LOCF method was applied.|||tender joints||Full Range|Median
2615367|NCT02001987|Secondary|Change From Baseline in SJC at Week 24 and at Last Assessment|A total of 28 joints were assessed for swelling. The number of swollen joints at could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity.|Baseline, Week 24, last assessment (up to Week 76)|LTE population; In case of missing value at Week 24, LOCF method was applied.|||swollen joints||Full Range|Median
2615368|NCT02001987|Secondary|Change From Baseline in SJC at Weeks 2, 4, 8, 12, 16, 20, and 24|A total of 28 joints were assessed for swelling. The number of swollen joints at could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity.|Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24|FAS; Here, 'Number Analyzed' signifies number of participants evaluable at specified time points for different arms, respectively. In case of missing value at Week 24, LOCF method was applied.|||swollen joints||Full Range|Median
2615369|NCT02001987|Secondary|Percentage of Participants With CDAI LDA and Remission at Week 24 and at Last Assessment|CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA and Physician's global assessment of disease activity according to 100-mm VAS. Higher scores represent greater affection due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, </=10 indicates LDA, </=22 indicates moderate disease activity, and >22 indicates high disease activity. Percentage of participants with CDAI LDA and remission at Week 24 and at last assessment is reported.|Week 24, last assessment (up to Week 76)|LTE population; Missing data was considered as non-response.|||percentage of participants|||Number
2615370|NCT02001987|Secondary|Change From Baseline in CDAI at Week 24 and at Last Assessment|CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA and Physician's global assessment of disease activity according to 100-mm VAS. Higher scores represent greater affection due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, </=10 indicates LDA, </=22 indicates moderate disease activity, and >22 indicates high disease activity. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity.|Baseline, Week 24, last assessment (up to Week 76)|LTE population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points. In case of missing value at Week 24, LOCF method was applied.|||units on a scale||Standard Deviation|Mean
2615371|NCT02001987|Secondary|Percentage of Participants With CDAI LDA and Remission at Week 24|CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA and Physician's global assessment of disease activity according to 100-mm VAS. Higher scores represent greater affection due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, </=10 indicates LDA, </=22 indicates moderate disease activity, and >22 indicates high disease activity. Percentage of participants with CDAI LDA and remission at Week 24 is reported. 95% CI was determined using Clopper-Pearson method.|Week 24|FAS; Missing data was considered as non-response.|||percentage of participants||95% Confidence Interval|Number
2615398|NCT02001558|Secondary|Pressure Ulcer Scale for Healing (PUSH) Score|PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).|at baseline||||score on a scale||Full Range|Median
2615640|NCT01998906|Secondary|Percentage of Participants Surviving at 1 Year||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS|||percentage of participants||95% Confidence Interval|Number
2615372|NCT02001987|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 12, 16, 20, and 24|CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA and Physician's global assessment of disease activity according to 100-mm VAS. Higher scores represent greater affection due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, </=10 indicates LDA, </=22 indicates moderate disease activity, and >22 indicates high disease activity. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity.|Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24|FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points for different arms, respectively. In case of missing value at Week 24, LOCF method was applied.|||units on a scale||Standard Deviation|Mean
2615373|NCT02001987|Secondary|Percentage of Participants With SDAI LDA and Remission at Week 24 and at Last Assessment|SDAI is a numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA and Physician's global assessment of disease activity according to 100-mm VAS and CRP in mg/dL. Higher scores indicate greater affection due to disease activity. SDAI total score = 0-86. SDAI </=3.3 indicates disease remission, </=11 indicates LDA, </=26 indicates moderate disease activity, and >26 indicates high disease activity. Percentage of participants with SDAI LDA and remission at Week 24 and at last assessment is reported.|Week 24, last assessment (up to Week 76)|LTE population; Missing data was considered as non-response.|||percentage of participants|||Number
2615374|NCT02001987|Secondary|Change From Baseline in SDAI at Week 24 and at Last Assessment|SDAI is a numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA and Physician's global assessment of disease activity according to 100-mm VAS and CRP in mg/dL. Higher scores indicate greater affection due to disease activity. SDAI total score = 0-86. SDAI </=3.3 indicates disease remission, </=11 indicates LDA, </=26 indicates moderate disease activity, and >26 indicates high disease activity. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity.|Baseline, Week 24, last assessment (up to Week 76)|LTE population; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points. In case of missing value at Week 24, LOCF method was applied.|||units on a scale||Standard Deviation|Mean
2615375|NCT02001987|Secondary|Percentage of Participants With SDAI LDA and Remission at Week 24|SDAI is a numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA and Physician's global assessment of disease activity according to 100-mm VAS and CRP in mg/dL. Higher scores indicate greater affection due to disease activity. SDAI total score = 0-86. SDAI </=3.3 indicates disease remission, </=11 indicates LDA, </=26 indicates moderate disease activity, and >26 indicates high disease activity. Percentage of participants with SDAI LDA and remission at Week 24 is reported. 95% CI was determined using Clopper-Pearson method.|Week 24|FAS; Missing data was considered as non-response.|||percentage of participants||95% Confidence Interval|Number
2615376|NCT02001987|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, and 24|SDAI is a numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PGA and Physician's global assessment of disease activity according to 100-mm VAS and CRP in mg per deciliter (dL). Higher scores indicate greater affection due to disease activity. SDAI total score = 0-86. SDAI </=3.3 indicates disease remission, </=11 indicates LDA, </=26 indicates moderate disease activity, and >26 indicates high disease activity. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity.|Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24|FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points for different arms, respectively. In case of missing value at Week 24, LOCF method was applied.|||units on a scale||Standard Deviation|Mean
2615377|NCT02001987|Secondary|Percentage of Participants With EULAR Response Based on DAS28-ESR at Week 24 and at Last Assessment|The DAS28-ESR-based EULAR response criteria were used to measure individual response as 'Good', 'Moderate', and 'No Response', depending upon DAS28-ESR absolute scores at Week 24 and the DAS28-ESR reduction from Baseline to Week 24. Good Response: change from baseline >1.2 with DAS28-ESR score </=3.2; Moderate Response: change from baseline >1.2 with DAS28-ESR score >3.2 to </=5.1 or change from baseline >0.6 to </=1.2 with DAS28-ESR score </=5.1; No Response: change from baseline </=0.6 or change from baseline >0.6 and </=1.2 with DAS28-ESR score >5.1. Percentage of participants with EULAR responses at Week 24 and at last assessment is reported.|Baseline, Week 24, last assessment (up to Week 76)|LTE population; Missing data was considered as non-response.|||percentage of participants|||Number
2615378|NCT02001987|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-ESR at Week 24|The DAS28-ESR-based EULAR response criteria were used to measure individual response as 'Good', 'Moderate', and 'No Response', depending upon DAS28-ESR absolute scores at Week 24 and the DAS28-ESR reduction from Baseline to Week 24. Good Response: change from baseline >1.2 with DAS28-ESR score </=3.2; Moderate Response: change from baseline >1.2 with DAS28-ESR score >3.2 to </=5.1 or change from baseline >0.6 to </=1.2 with DAS28-ESR score </=5.1; No Response: change from baseline </=0.6 or change from baseline >0.6 and </=1.2 with DAS28-ESR score >5.1. Percentage of participants with EULAR responses at Week 24 is reported. 95% CI was determined using Clopper-Pearson method.|Baseline, Week 24|FAS; Missing data was considered as non-response.|||percentage of participants||95% Confidence Interval|Number
2615379|NCT02001987|Secondary|Percentage of Participants Achieving ACR20, ACR50, and ACR70 Response at Week 24 and at Last Assessment|The ACR 20, 50, and 70 responses at any time is defined as >/=20%, 50%, and 70% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 20%, 50%, 70% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) PGA according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/L). Percentage of participants with ACR 20, 50, and 70 responses at Week 24 and at last assessment is reported.|Baseline, Week 24, last assessment (up to Week 76)|LTE population; Missing data was considered as non-response.|||percentage of participants|||Number
2615380|NCT02001987|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response at Week 24|The ACR 20, 50, and 70 responses at any time was defined as greater than or equal to (>/=) 20%, 50%, and 70% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 20%, 50%, 70% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) PGA according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via a Health Assessment Questionnaire-Disability Index (HAQ-DI), and 5) Acute phase reactant (ESR in mm/h or C-Reactive Protein [CRP] in milligrams per liter [mg/L]). Percentage of participants with ACR 20, 50, and 70 responses at Week 24 is reported. 95% CI was determined using Clopper-Pearson method.|Baseline, Week 24|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure. Missing data was considered as non-response.|||percentage of participants||95% Confidence Interval|Number
2615381|NCT02001987|Secondary|Percentage of Participants With DAS28-ESR LDA and Remission at Week 24 and at Last Assessment|The DAS28-ESR was derived from assessments of ESR, TJC, SJC, and PGA according to 100-mm VAS. DAS28-ESR scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of painful joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28-ESR scores could range from 0 to 10, where higher scores represented higher disease activity. DAS28-ESR score </=3.2 indicates LDA, DAS28-ESR score >3.2 indicates moderate to high disease activity, and DAS28-ESR <2.6 indicates remission. Percentage of participants with DAS28-ESR LDA and remission at Week 24 and at last assessment is reported.|Week 24, last assessment (up to Week 76)|LTE population; In case of missing value at Week 24, LOCF method was applied.|||percentage of participants|||Number
2615382|NCT02001987|Secondary|Change From Baseline in DAS28-ESR at Week 24 and at Last Assessment|The DAS28-ESR was derived from assessments of ESR, TJC, SJC, and PGA according to 100-millimeter (mm) VAS. DAS28-ESR scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of painful joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28-ESR scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity.|Baseline, Week 24, last assessment (up to Week 76)|LTE population included all FAS participants who received at least one dose of SC TCZ after Week 24 visit. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. In case of missing value at Week 24, LOCF method was applied.|||units on a scale||Standard Deviation|Mean
2615383|NCT02001987|Secondary|Percentage of Participants With DAS28-ESR Low Disease Activity (LDA) and Remission at Week 24|The DAS28-ESR was derived from assessments of ESR, TJC, SJC, and PGA according to 100-mm VAS. DAS28-ESR scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of painful joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28-ESR scores could range from 0 to 10, where higher scores represented higher disease activity. DAS28-ESR score less than or equal to (</=) 3.2 indicates LDA, DAS28-ESR score greater than (>) 3.2 indicates moderate to high disease activity, and DAS28-ESR less than (<) 2.6 indicates remission. Percentage of participants with DAS28-ESR LDA and remission at Week 24 is reported. 95 percent (%) confidence interval (CI) was determined using Clopper-Pearson method.|Week 24|FAS; In case of missing value at Week 24, LOCF method was applied.|||percentage of participants||95% Confidence Interval|Number
2615384|NCT02001987|Secondary|Change From Baseline in DAS28-ESR at Weeks 2, 4, 8, 12, 16, 20, and 24|The DAS28-ESR was derived from assessments of ESR, TJC, SJC, and PGA according to 100-mm VAS. DAS28-ESR scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of painful joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in mm/h. DAS28-ESR scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity.|Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24|FAS; Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants evaluable at specified time points for different arms, respectively. In case of missing value at Week 24, LOCF method was applied.|||units on a scale||Standard Deviation|Mean
2615385|NCT02001987|Primary|Change From Baseline in Disease Activity Score Based on 28-joints Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 24|The DAS28-ESR was derived from assessments of erythrocyte sedimentation rate (ESR), tender joint count (TJC), swollen joint count (SJC), and Patient Global Assessment of disease activity (PGA) according to 100-millimeter (mm) Visual Analog Scale (VAS). DAS28-ESR scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. TJC was defined as the number of painful joints and SJC was defined as the number of swollen joints, each assessed on 28 joints. ESR was measured in millimeters per hour (mm/h). DAS28-ESR scores could range from 0 to 10, where higher scores represented higher disease activity. The change from Baseline to Week 24 was averaged among all participants, where negative changes indicated an improvement in disease activity.|Baseline, Week 24|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure. In case of missing value, Last Observation Carried Forward (LOCF) method was applied.|||units on a scale||Standard Deviation|Mean
2615386|NCT02001714|Secondary|Group Behavioral Treatment Cost-effectiveness|Measure resource use and utilities and compare the difference in incontinence management costs and utilities between treatment and control group.|12 months|||||||
2615399|NCT02001558|Primary|Pressure Ulcer Size (Length x Width x Depth, cm^3) at 24 Weeks After Baseline|Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.|24 weeks after baseline|"Microcyn arm: there were 12 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 19 participants lost to follow up during this evaluation period."|||cm^3||Full Range|Median
2615387|NCT02001714|Primary|Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity.|The primary outcome is the self-reported urinary incontinence severity as measured by the International Consultation on Incontinence questionnaire-short form (ICI-Q). This short and simple questionnaire is used to screen for incontinence (urine leakage) to obtain a brief yet comprehensive summary of the level, impact and perceived cause of symptoms of incontinence. The ICI-Q consists of four questions and numeric scales: 1. How much do you leak urine? (0-5); never - all the time, 2. How much urine do you usually leak? (0-6); none - large amount, 3. Overall, how much does leaking urine interfere with your everyday life? (0-10); not at all - a great deal, 4. When does urine leak? Multiple choices. The ICI-Q score is the sum of questions 1-3 and ranges from 0-21. The higher the score, the greater severity of incontinence. Baseline data is compared to the 3 month data for the primary outcome.|Baseline and 3 months|The Group Behavioral Treatment group population at baseline is 232. At the 3 month follow-up visit 16 had withdrawn and 7 missed the appointment, leaving 209 for the total number analyzed. For the No Treatment group, the number at baseline is 231 and by the 3 month visit 8 had withdrawn and another 11 missed the appointment, leaving 212.|||units on a scale||Inter-Quartile Range|Median
2615388|NCT02001688|Secondary|Change From Baseline in AAT-neutrophil Elastase (NE) Complexes in ELF|Patients underwent a BAL procedure at baseline and 12 weeks and the fluid was analyzed to calculate the change from baseline in the concentration of complexes between AAT and neutrophil elastase in the ELF|12 weeks from initiation of study drug||||nM||95% Confidence Interval|Median
2615389|NCT02001688|Secondary|Change From Baseline in Levels of M Specific AAT in Plasma (PiM)|Intention to treat (ITT) population with baseline and 12 week values.The median change from baseline to Week 12 in the levels of M-specific AAT (piM) in plasma was measured using a specific ELISA assay for M-specific AAT (piM)|12 weeks from initiation of study drug||||nM||95% Confidence Interval|Median
2615390|NCT02001688|Primary|Change From Baseline to 12 Weeks in the Concentration of Functional AAT (Alpha-1 Antitrypsin) in ELF|ITT population with baseline and 12 week values. Patients underwent bronchoalveolar lavage (BAL) prior to initiation of drug and then again after 3 months. Concentration of AAT in the BAL was measured by an antineutrophil elastase capacity (ANEC) assay. Urea was also measured in order to determine the dilution factor of the BAL fluid and calculate the concentration of AAT in the ELF.|12 weeks from initiation of study drug||||nmol||95% Confidence Interval|Median
2615391|NCT02001688|Primary|Change From Baseline in the Concentration of Antigenic Alpha-1 Antitrypsin (AAT) in the Lung Epithelial Lining Fluid (ELF)|Patients underwent bronchoalveolar lavage (BAL) prior to initiation of drug and then again after 3 months. Concentration of AAT in the BAL was measured by an enzyme linked immunosorbent assay (ELISA) specific for the normal form of AAT (piM). Urea was also measured in order to determine the dilution factor of the BAL fluid and calculate the concentration of AAT in the ELF.|12 weeks from initiation of study drug|Intention to treat (ITT) population with values available in BAL at baseline and 12 weeks|||nmol||95% Confidence Interval|Median
2615392|NCT02001558|Secondary|Pressure Ulcer Scale for Healing (PUSH) Score at 24 Weeks After Baseline|PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).|24 weeks after baseline|"Microcyn arm: there were 12 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 19 participants lost to follow up during this evaluation period."|||score on a scale||Full Range|Median
2615393|NCT02001558|Secondary|Pressure Ulcer Scale for Healing (PUSH) Score at 20 Weeks After Baseline|PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).|20 weeks after baseline|"Microcyn arm: there were 12 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 25 participants lost to follow up during this evaluation period."|||score on a scale||Full Range|Median
2615394|NCT02001558|Secondary|Pressure Ulcer Scale for Healing (PUSH) Score at 16 Weeks After Baseline|PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).|16 weeks after baseline|"Microcyn arm: there were 13 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 19 participants lost to follow up during this evaluation period."|||score on a scale||Full Range|Median
2615395|NCT02001558|Secondary|Pressure Ulcer Scale for Healing (PUSH) Score at 12 Weeks After Baseline|PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).|12 weeks after baseline|"Microcyn arm: there were 9 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 19 participants lost to follow up during this evaluation period."|||score on a scale||Full Range|Median
2615396|NCT02001558|Secondary|Pressure Ulcer Scale for Healing (PUSH) Score at 8 Weeks After Baseline|PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).|8 weeks after baseline|"Microcyn arm: there were 12 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 17 participants lost to follow up during this evaluation period."|||score on a scale||Full Range|Median
2615397|NCT02001558|Secondary|Pressure Ulcer Scale for Healing (PUSH) Score at 4 Weeks After Baseline|PUSH categorizes pressure ulcer by surface area, exudate, and type of wound tissue. A comparison of total scores measured over time provides an indication of the improvement or deterioration in pressure ulcer healing. Total score ranges from 0 (healed, normal) to 17 (most severe).|4 weeks after baseline|"Microcyn arm: there were 8 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 12 participants lost to follow up during this evaluation period."|||score on a scale||Full Range|Median
2615699|NCT01998399|Secondary|Stroke, Myocardial Infarct, Mortality|number of participants that suffered stroke, myocardial infarct, mortality|90 days||||Participants|||Count of Participants
2615401|NCT02001558|Primary|Pressure Ulcer Size (Length x Width x Depth, cm^3) at 16 Weeks After Baseline|Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.|16 weeks after baseline|"Microcyn arm: there were 13 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 19 participants lost to follow up during this evaluation period."|||cm^3||Full Range|Median
2615402|NCT02001558|Primary|Pressure Ulcer Size (Length x Width x Depth, cm^3) at 12 Weeks After Baseline|Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.|12 weeks after baseline|"Microcyn arm: there were 9 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 18 participants lost to follow up during this evaluation period."|||cm^3||Full Range|Median
2615403|NCT02001558|Primary|Pressure Ulcer Size (Length x Width x Depth, cm^3) at 8 Weeks After Baseline|Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.|8 weeks after baseline|"Microcyn arm: there were 12 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 17 participants lost to follow up during this evaluation period."|||cm^3||Full Range|Median
2615404|NCT02001558|Primary|Pressure Ulcer Size (Length x Width x Depth, cm^3) at 4 Weeks After Baseline|Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.|4 weeks after baseline|"Microcyn arm: there were 8 participants lost to follow up during this evaluation period.~Sterile saline arm: there were 10 participants lost to follow up during this evaluation period."|||cm^3||Full Range|Median
2615405|NCT02001558|Primary|Pressure Ulcer Size (Length x Width x Depth, cm^3) at Baseline|Pressure ulcer size is measured after debridement if debridement is provided. The pressure ulcer size (cubic centimeter) is the length (centimeter) times the width (centimeter) times the depth(centimeter). The range of value is from 0 to positive infinite.|pressure ulcer size (length x width x depth, cm^3) at baseline||||cm^3||Full Range|Median
2615406|NCT02001194|Secondary|Average Number of Steps Per Day During Intervention|Secondary outcomes include average number of steps per day during intervention period and the follow-up period.|End of study- 6 months after enrollment||||steps per day||95% Confidence Interval|Mean
2615407|NCT02001194|Primary|Proportion of Days a Minimum Activity of 7000 Steps or More is Achieved|Our primary outcome measure is the proportion of days a minimum activity of 7000 steps or more is achieved. We will assess outcomes for 3 months (13 weeks) with the interventions and 3 months (13 weeks) without intervention during the follow-up period. We will use all available data and treat missing as true missing data points. Secondary outcomes will include the average steps walked per day.|End of study- 6 months of after enrollment||||Proportion of participant-days||95% Confidence Interval|Mean
2615408|NCT02001181|Secondary|Change From Baseline in the EASI Clinical Signs Severity Sum Score at Week 4|The EASI Clinical Signs Severity Sum Score was derived from the EASI. The Clinical Signs Severity Scores on the 4-point scale for dermatitis lesions were summed in each EASI body region. The sum of the Clinical Signs Severity Score in each EASI body region was then totaled across the 4 EASI body regions to provide an EASI Clinical Signs Severity Sum Score, which ranged from 0 to 48, with higher scores representing greater severity of atopic dermatitis.|Baseline (pre-dose on Day 1) and Week 4|The FAS included all participants who were randomized and received at least 1 dose of study drug. Missing data was not imputed. N=number of participants who were in FAS and had a baseline value and an observation at Week 4.|||units on a scale||Standard Deviation|Mean
2615409|NCT02001181|Secondary|Percent Change From Baseline in Body Surface Area (BSA) Efficacy at Week 4|The percent BSA with atopic dermatitis in a body region was determined by the number of handprints of atopic dermatitis skin in that region: head and neck, upper limbs, trunk including axillae, lower limbs including buttocks. In the handprint method, the full palmar hand of the participant (i.e., the participant's fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. What is reported is the percent change from baseline in BSA affected.|Baseline (pre-dose on Day 1) and Week 4|The FAS included all participants who were randomized and received at least 1 dose of study drug. Missing data was not imputed. N=number of participants who were in FAS and had a baseline value and an observation at Week 4.|||percent change||Standard Deviation|Mean
2615410|NCT02001181|Secondary|Proportion of Participants With Response of Clear or Almost Clear and Greater Than or Equal to (>=) 2 Grade/Point Improvement From Baseline at Week 4|The PGA score assesses the overall severity of atopic dermatitis. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate, and severe, respectively) based on morphological descriptors.|Baseline (pre-dose on Day 1) and Week 4|The FAS included all participants who were randomized and received at least 1 dose of study drug. Participants who were in FAS and had a baseline PGA score of 2 or 3 were included in the analysis. Participants with missing data at Week 4 were considered non-responders.|||percentage of participants|||Number
2615411|NCT02001181|Secondary|Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 4|The PGA score assesses the overall severity of atopic dermatitis. Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate, and severe, respectively) based on morphological descriptors.|Week 4|The FAS included all participants who were randomized and received at least 1 dose of study drug. Participants who were in FAS and had a baseline PGA score of 2 or 3 were included in the analysis. Participants with missing data at Week 4 were considered non-responders.|||percentage of participants|||Number
2615429|NCT02000908|Primary|Change of Total Neuropathy Score|"For each patient, we will compute the difference between the total neuropathy score at 8 weeks (the end of treatment) and the total neuropathy score at the time of randomization. The mean change in score for the experimental group patients will be compared to the mean change in score for the control group patients using a two-sample t-test.~Scale scoring is 0-<20 0 being no pain <20 =severe"|Baseline 8 weeks||||units on a scale||Standard Error|Mean
2615700|NCT01998399|Secondary|Stroke|Did the patient develop a stroke during the 90 day study?|90 days||||Participants|||Count of Participants
2615412|NCT02001181|Primary|Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4|The EASI quantifies the severity of a participant's atopic dermatitis based on both lesion severity and the percent of BSA affected. The EASI is a composite scoring by the atopic dermatitis clinical evaluator of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis. What is reported is the percent change from baseline in EASI scores.|Baseline (pre-dose on Day 1) and Week 4|The full analysis set (FAS) included all participants who were randomized and received at least 1 dose of study drug. Missing data was not imputed. N=number of participants who were in FAS and had a baseline value and an observation at Week 4.|||percent change||Standard Error|Least Squares Mean
2615413|NCT02001051|Secondary|Correlation Between Dermal Thickness and Patients With Subclinical Hypercortisolism|A skin biopsy and skin ultrasound were done to measure the dermal layer of skin to look for a decrease in the thickness of skin as compared to normal values reported in the literature as measured in millimeters of thickness. Diagnostic sensitivity and changes in skin thickness were assessed.|Assessed at 6 months||||Participants|||Count of Participants
2615414|NCT02001051|Secondary|Proportion of Patients That Developed Deep Venous Thrombosis With Subclinical Hypercortisolism|Proportion of patients that developed deep venous thrombosis with subclinical hypercortisolism regardless of whether the participants received adrenalectomy or not.|Assessed at 6 months||||proportion of participants|||Number
2615415|NCT02001051|Secondary|Proportion of Patients That Have Improvement in Quality of Life (QOL) After Adrenalectomy Compared to Medical Therapy|QOL questionnaires were provided to participants to assess well being pre and post operatively. Participants take a self-administered questionnaire to assess physical and mental health according to Cushing's Quality of Life Questionnaire. The score has a minimum of 12 and maximum of 60. A higher score indicates an improved quality of life.|Assessed at 6 months||||proportion of participants|||Number
2615416|NCT02001051|Secondary|To Determine the Optimal Diagnostic Test for Subclinical Hypercortisolism|An assessment of whether 1 mg dexamethasone suppression test, basal adrenocorticotropic hormone (ACTH), midnight salivary cortisol, or urinary free cortisol is the optimal test to diagnose patients with subclinical hypercortisolism.|Assessed at 6 months|This outcome measure was not done. Data was collected and not analyzed because we were not able to determine the optimal test since we only had four patients enrolled, and three patients on study (e.g. low accrual). Therefore, we couldn’t do a head to head comparison calculating the sensitivity and specificity.||||||
2615417|NCT02001051|Secondary|Proportion of Patients Who Were Diagnosed With Subclinical Hypercortisolism by Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT) Scan|Proportion of patients who were diagnosed with subclinical hypercortisolism by FDG/PET/CT scan.|Assessed at 6 months||||proportion of participants|||Number
2615418|NCT02001051|Secondary|Proportion of Patients Who Are Found to Have Adrenal Cancer After Adrenalectomy|Patients who were tested for and found to have adrenal cancer after adrenalectomy.|Assessed at 6 months||||proportion of participants|||Number
2615419|NCT02001051|Primary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 39 months and 27 days|No toxicities were experienced by any participants on this trial.|||Participants|||Count of Participants
2615420|NCT02001051|Primary|Proportion of Patients That Have Normalization and/or Improvement of Metabolic Complications After Adrenalectomy|Normalization and/or improvement of metabolic complications including hypertension, diabetes, osteoporosis, hypercholesterolemia and/or obesity after adrenalectomy is defined as 35% of patients who improve with surgery versus 5% who do not have surgery.|Assessed at 6 months||||proportion of participants|||Number
2615421|NCT02000973|Secondary|Bispectral Index Score|The bispectral index(BIS) score of each patient was recorded at two different time points. BIS values varies from 0 to 100(0, no cerebral activity; 40 to 60, general anesthesia; 60 to 85, sedated; 85 to 100, awake).|Before starting anesthesia to finishing endotracheal intubation||||units on a scale||Standard Deviation|Mean
2615422|NCT02000973|Secondary|Heart Rate|The heart rate of each patient was recorded at five different time points|Before starting anesthesia to finishing endotracheal intubation||||beats per minute||Standard Deviation|Mean
2615423|NCT02000973|Secondary|Mean Arterial Pressure|The mean arterial pressure of each patient was recorded at five different time points|Before starting anesthesia to finishing endotracheal intubation||||mmHg||Standard Deviation|Mean
2615424|NCT02000973|Primary|Propofol Effect-site Concentration|The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.|Before starting anesthesia to finishing endotracheal intubation||||ug/ml||Standard Deviation|Mean
2615425|NCT02000921|Secondary|Carcinogen Exposure Biomarker: Total NNAL|Total NNAL (pmol/mg creatinine) is a measure of carcinogen exposure assessed at the end of intervention.|Week 8 (end of intervention)||||pmol//mg creatinine||95% Confidence Interval|Mean
2615426|NCT02000921|Secondary|Rate of 24 Hour Quit Attempts|Rate of 24 hour quit attempts during the intervention period|8 week intervention period||||Participants|||Count of Participants
2615427|NCT02000921|Primary|Number of Combusted Products Smoked|Number of combusted products smoked per day during the last two weeks of the intervention period.|At weeks 6-8 (last two weeks of intervention period)||||combuster products per day||Standard Deviation|Mean
2615428|NCT02000921|Primary|Number of Days Using Alternative Products|The primary aim of the study is to determine the rate of use of alternative nicotine-containing products across the three experimental conditions.|8 week intervetnion period||||Number of days||Standard Deviation|Mean
2615431|NCT02000817|Secondary|Change From Baseline in Bound CD3 Copies on CD8+ Cells|Whole blood samples were drawn and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. NA indicates that standard deviation could not be calculated for a single participant.|Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14|Fully treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Copies per cell||Standard Deviation|Mean
2615432|NCT02000817|Secondary|Change From Baseline in Bound CD3 Copies on CD4+ Cells|Whole blood samples were drawn and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. NA indicates that standard deviation could not be calculated for a single participant.|Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14|Fully treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Copies per cell||Standard Deviation|Mean
2615433|NCT02000817|Secondary|Change From Baseline in Free CD3 on CD4+ Cells|Whole blood samples were drawn and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. NA indicates that standard deviation could not be calculated for a single participant.|Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14|Fully treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Copies per cell||Standard Deviation|Mean
2615434|NCT02000817|Secondary|Change From Baseline in Free CD3 on CD8+ Cells|Whole blood samples were drawn and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. NA indicates that standard deviation could not be calculated for a single participant.|Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14|Fully treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Copies per cell||Standard Deviation|Mean
2615435|NCT02000817|Secondary|Relative Change From Baseline in Percentage (%) in CD8+ Cells|Whole blood samples were collected and analyzed by flow cytometry. Day1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Relative change from baseline (%) was calculated as change from Baseline relative to Baseline in %. NA indicates that standard deviation could not be calculated for a single participant.|Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14|Fully treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Percentage||Standard Deviation|Mean
2615436|NCT02000817|Secondary|Relative Change From Baseline in Percentage (%) in CD4+ Cells|Whole blood samples were collected and analyzed by flow cytometry. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Relative change from Baseline (percentage) was calculated as change from Baseline relative to Baseline in percentage.|Day 1 (30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 12 hours, 16 hours), Day 2, Day 3, Day 4, Day 5, Day 6 (1 hour), Day 14|Fully treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Percentage||Standard Deviation|Mean
2615437|NCT02000817|Secondary|Time-normalized Number of Hypoglycemic and Hyperglycemic Events|As per American Diabetes Association (ADA), hypoglycemia is defined as blood glucose level <= 70 milligram/deciliter (mg/dl) and hyperglycemia is defined as blood glucose level > 250 mg/dL. Hypoglycaemic and hyperglycaemic events will be recorded in a diary whenever they occur, along with the start and stop dates. Mean number of events is defined as the average number of events reported per subject. Normalization is expressed by dividing number of events by length of reporting period in month (1 month = 30 days).|Up to Month 24|ITT treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Number of events||Standard Deviation|Mean
2615438|NCT02000817|Secondary|Absolute Body Weight|Body weight was measured at indicated time points.|Day-1, Month 12, Month 18 and Month 24|ITT treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Kilogram||Standard Deviation|Mean
2615439|NCT02000817|Secondary|Change From Baseline in Hemoglobin A1c|Hemoglobin A1C levels were measured at indicated time points. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day-1), Month 6, Month 12 and Month 24|ITT treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Percentage of HbA1c||Standard Deviation|Mean
2615440|NCT02000817|Secondary|Change From Baseline in Mean Daily Insulin Use|Participants were asked to record their daily insulin usage thoroughly and accurately in a diary from 7 days prior to study visit. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day-1), Week 2, Week 3, Week 6, Week 8, Week 12, Week 24, Week 36, Week 48, Week 72 and Week 96|ITT treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||International unit||Standard Deviation|Mean
2615441|NCT02000817|Secondary|Change From Baseline in Insulin Sensitivity (IS) Index From Hyperglycemic Clamp Test|Insulin sensitivity index is defined as the ratio of glucose metabolized and average insulin concentration multiplied by 100 by hyperglycemic clamp test. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline (Day-1), Month 6, Month 24|ITT treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||(100*mmol*l)/(pmol*kg*min)||Standard Deviation|Mean
2615701|NCT01998399|Secondary|Hospital Free Days|Number of days the patient is not in the hospital|29 days|2 participants from each group died during this time period|||days||Full Range|Mean
2615442|NCT02000817|Secondary|Change From Baseline in Glucose Weighted Mean (Area Under Curve From 60 to 140 Minutes, AUC60-140 Minutes) From Hyperglycemic Clamp Test|Blood samples were collected at indicated time points to assess levels of glucose during hyperglycemic (H) phase. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Glucose AUC was calculated from area under the C-peptide/time curve from time H60 to H140 minutes.|Baseline (Day-1), Month 6 and Month 24|ITT treated population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|||Millmoles minute per liter||Standard Deviation|Mean
2615443|NCT02000817|Secondary|Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 60 to 140 Minutes, [AUC 60-140 Minutes]) From Hyperglycemic Clamp Test|Blood samples were collected at indicated time points to assess levels of C-peptide during hyperglycemic (H) phase. Day-1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from specified time point value. C-peptide AUC was calculated from area under C-peptide/time curve from time H60 to H140 minutes.|Baseline (Day-1), Month 6, Month 24|ITT treated population. Only those participants with data available at specified time points were analyzed (represented by n=X in the category titles).|||Nanomoles minute per liter||Standard Deviation|Mean
2615444|NCT02000817|Secondary|Change From Baseline in Glucose Weighted Mean (Area Under Curve From 0 to 120 Minutes, AUC0-120 Minutes) From Mixed Meal Tolerance Test|Blood samples were collected at indicated time points to assess levels of glucose. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Mixed meal-stimulated glucose was calculated from area under the glucose /time curve from time 0 to 120 minutes, using trapezoidal rule.|Baseline (Day-1), Month 3, Month 6, Month 12, Month 18 and Month 24|ITT treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Millmoles minute per liter||Standard Deviation|Mean
2615445|NCT02000817|Secondary|Change From Baseline in C-Peptide Weighted Mean (Area Under Curve From 0 to 120 Minutes [AUC0-120 Minutes]) From Mixed Meal Tolerance Test|Blood samples were collected at indicated time points to assess levels of C-peptide. Day -1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Mixed meal-stimulated C-peptide AUC was calculated from area under C-peptide/time curve from time 0 to 120 minutes, using trapezoidal rule. ITT treated population comprised of all randomized participants who received at least one dose of study treatment.|Baseline (Day-1), Month 3, Month 6, Month 12, Month 18 and Month 24|Intent-To-Treat (ITT) treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Nanomoles minute per liter||Standard Deviation|Mean
2615446|NCT02000817|Secondary|Free Serum Otelixizumab Concentrations by Treatment|Blood samples were collected at designated timepoints. Free serum Otelixizumab concentrations were calculated by linear and semi-logarithmic individual serum concentration-time profiles. Fully treated population comprised of all randomized participants who received the full 6 days of treatment based on actual exposure data. NA indicates that data could not be calculated as >30% of samples were below the limit of quantification.|Pre-dose on Day 1,2,3,4,5,6 and 14; 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 9 hours, 16 hours post-dose on Day 1, and 1 hour post-dose on Day 6.|Fully Treated population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2615447|NCT02000817|Primary|Number of Participants With Abnormal Vital Sign Results|Vital signs were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. Vital signs included systolic, diastolic blood pressure, pulse rate and respiratory rate|Up to Month 24|Safety population|||Participants|||Number
2615448|NCT02000817|Primary|Number of Participants With Increase in QT Interval Corrected for Heart Rate (QTc)|12-lead electrocardiograms (ECGs) were obtained in semi-supine position after 5 minutes rest for the participants at indicated time points to measure QTc.|Up to Month 24|Safety population|||Participants|||Number
2615449|NCT02000817|Primary|Number of Participants With Abnormal Laboratory Results|Blood samples were collected to analyze the laboratory parameters which included alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bilirubin, calcium, chloride, creatinine, direct bilirubin, glucose, potassium, protein, sodium, urate, urea nitrogen, basophil, eosinophil, mean corpuscular haemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), mean corpuscular volume (MCV), erythrocytes, haematocrit, haemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, platelets and reticulocytes.|Up to Month 24|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Number
2615450|NCT02000817|Primary|Epstein-Barr Virus (EBV) Viral Load Detection|Blood samples were collected for analysis of EBV viral load and detection was done by polymerase chain reaction (PCR).|Week 3, Week 6, Week 8, Week 12, Week 24 and Week 96|Safety population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Copies per million cells||Geometric Coefficient of Variation|Geometric Mean
2615451|NCT02000817|Primary|Number of Participants With Adverse Events (AEs) Related to Cytokine Release Syndrome (CRS)|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs have been reported. Safety Population comprised of all participants who received at least one dose of study treatment.|Up to Day 14|Safety population|||Participants|||Number
2615452|NCT02000752|Secondary|Degree of Ease With Which the Acupuncturist Administered the Treatment|"The degree of ease with which the acupuncturist administered the treatment was measured in a survey that the midwife carries out no more than 2 hours after the labor. The value was recorded using a numerical scale ranging between 0-100, with 4 levels: 100 - high ease, 75 - moderate ease, 50 - medium ease and 25 - low ease"|Measured into the 2 hours after the childbirth but before puerperal woman is moved to the obstetrics plant out of the labor room||||units on a scale||Standard Deviation|Mean
2615702|NCT01998399|Secondary|In-hospital Mortality|Did the patient die during the hospitalization?|Throughout hospitalization (About 2 weeks)||||Participants|||Count of Participants
2615456|NCT02000622|Other Pre-specified|Time to Second Subsequent Cancer Therapy or Death (TSST)|Time from randomisation to the earliest of second subsequent cancer therapy start date following study treatment discontinuation, or death.|Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation. Assessed up to a maximum of 30 months.|Full Analysis Set (FAS) consisting of all randomised patients|||Months||95% Confidence Interval|Median
2615457|NCT02000622|Other Pre-specified|Time to First Subsequent Cancer Therapy or Death (TFST)|Time from randomisation to the earliest of first subsequent cancer therapy start date following study treatment discontinuation, or death.|Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation. Assessed up to a maximum of 30 months.|Full Analysis Set (FAS) consisting of all randomised patients|||Months||95% Confidence Interval|Median
2615458|NCT02000622|Secondary|Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) in Patients Confirmed as Myriad CDx gBRCAm|Time from randomisation to the earliest of objective radiological progression or death by any cause in the absence of objective progression. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Assessed in patients with a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).|Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.|Subset of Full Analysis Set (FAS) consisting of all randomised patients who were confirmed as Myriad CDx gBRCAm|||Months||95% Confidence Interval|Median
2615459|NCT02000622|Secondary|Adjusted Mean Change in Global Health Status/Quality of Life (QoL) Score From the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)|Change from baseline in global health status/quality of life (QoL) score assessed using a mixed model for repeated measures (MMRM) analysis, including all post-baseline global health status/QoL scores up to the latest scheduled visit where at least 20 patients on each treatment arm have a score. Global health status/QoL score is on a scale from 0 to 100. A higher score represents an improved health status/QoL.|EORTC QLQ-C30 assessments performed at baseline then every ~6 weeks until objective radiological disease progression. Assessed up to a maximum of 30 months.|Subset of Full Analysis Set (FAS) consisting of all randomised patients with an evaluable baseline EORTC QLQ-C30 assessment and at least one evaluable post-baseline assessment|||Score on a scale||95% Confidence Interval|Mean
2615460|NCT02000622|Secondary|Objective Response Rate (ORR) Using Blinded Independent Central Review (BICR) Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)|Number of responders according to blinded independent central review (BICR) assessment. Per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1) for target lesions assessed by CT or MRI: Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions; Overall Response = CR + PR.|Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.|Evaluable For Response (EFR) Analysis Set consisting of all randomised patients with measurable disease at baseline, i.e. at least one measurable target lesion assessed by blinded independent central review (BICR)|||Participants|||Number
2615461|NCT02000622|Secondary|Overall Survival (OS)|Time from randomisation until death due to any cause.|Survival status reviewed every 3 weeks until treatment discontinued, then every 8 weeks. Assessed up to a maximum of 30 months.|Full Analysis Set (FAS) consisting of all randomised patients|||Months||95% Confidence Interval|Median
2615462|NCT02000622|Secondary|Time to Second Progression or Death (PFS2)|Time from randomisation to the earliest of the progression event subsequent to the first objective radiological progression, or death. Second progression may involve any of; objective radiological or symptomatic progression or death. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Symptomatic progression is assessed by investigators based on clinical examination.|Second progression status reviewed every 8 weeks following the first objective radiological progression as per investigator assessment. Assessed up to a maximum of 30 months.|Full Analysis Set (FAS) consisting of all randomised patients|||Months||95% Confidence Interval|Median
2615463|NCT02000622|Primary|Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)|Time from randomisation to the earliest of objective radiological progression or death by any cause in the absence of objective progression. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.|Full Analysis Set (FAS) consisting of all randomised patients|||Months||95% Confidence Interval|Median
2615464|NCT02000531|Secondary|Participants With Adverse Events||start of second-line treatment to data cut-off in December 2014 (within 12 months)|Safety Population, defined as all participants enrolled in this extension study|||participants|||Number
2615465|NCT02000531|Primary|Progression Free Survival (PFS) Based on Well-documented and Verifiable Progression Events|Progression free survival is defined as the time of randomization in ENSURE study to progressive disease (PD) while on second-line treatment or death from any cause, whichever occurred first during the second-line treatment.|within 3 years, 9 months (data cut-off December 2014)|Intention to treat population, defined as all participants enrolled in this extension study|||Months||95% Confidence Interval|Median
2615641|NCT01998906|Secondary|Overall Survival|OS was defined as the time from the date of randomization to the date of the death due to any cause.|BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS|||months||95% Confidence Interval|Median
2615466|NCT02000440|Secondary|Plasma Losmapimod 7.5 mg Maximum Observed Concentration (Cmax)|PK of losmapimod 7.5 mg was evaluated in participants with FSGS using Cmax PK samples were collected at Week 0 (pre-dose and 1, 2, 4, 6 hrs post-dose). Plasma concentration-time data were collected only up to 6 hours post the first 7.5 mg dose and only up to 2 hours post the first 15 mg dose and were not adequate to conduct a noncompartmental analysis to compare with historical data.|Week 0 (Pre-dose and 1, 2, 4, 6 hrs post-dose)|PK Population.||||||
2615467|NCT02000440|Secondary|(AUC[0-tau]) of Losmapimod 15 mg in Plasma|PK of losmapimod 15 mg was evaluated in participants with FSGS using AUC over the dosing interval of losmapimod 15 mg. PK samples were collected at Week 2 (Pre-dose, 2 hrs post-dose) and Week 4, 8, 16, 24 (one of the following post-dose times: 0-2 hrs, 2-4 hrs, 4-6 hrs, and 6-8 hrs post-dose). Plasma concentration-time data were collected only up to 6 hours post the first 7.5 mg dose and only up to 2 hours post the first 15 mg dose and were not adequate to conduct a noncompartmental analysis to compare with historical data.|Week 2 (Pre-dose, 2 hrs post-dose) and Week 4, 8, 16, 24 (at one of the following post-dose times: 0-2 hrs, 2-4 hrs, 4-6 hrs, and 6-8 hrs post-dose)|PK Population.||||||
2615468|NCT02000440|Secondary|Area Under Concentration-time Curve (AUC) From Time Zero to Time t (AUC[0-t]) and AUC From Time Zero to the End of Dosing Period (AUC[0-tau]) of Losmapimod 7.5 mg in Plasma|Pharmacokinetics (PK) of losmapimod 7.5 mg was evaluated in participants with focal segmental glomerulosclerosis (FSGS) using AUC over the dosing interval of losmapimod 7.5 mg. PK samples were collected at Week 0 (pre-dose and 1, 2, 4, 6 hrs post-dose). Plasma concentration-time data were collected only up to 6 hours post the first 7.5 mg dose and only up to 2 hours post the first 15 mg dose and were not adequate to conduct a noncompartmental analysis to compare with historical data.|Week 0 (Pre-dose and 1, 2, 4, 6 hrs post-dose)|PK Population: All participants from whom a PK sample obtained and analyzed, included in the PK population.||||||
2615469|NCT02000440|Secondary|Percent Change From Baseline in Cystatin C at Indicated Time Points|Cystatin C was assessed at Baseline (Week 0), at Weeks 2, 4, 8, 16, 24 and Follow-up (Week 30 and 36) phase. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population|||Percent change||Standard Deviation|Mean
2615470|NCT02000440|Secondary|Change From Baseline in Glomerular Filtration Rate (GFR) at Indicated Time Points|eGFR was calculated by using the 4-variable Modification of Diet in Renal Disease (MDRD) at Baseline (Week 0), at Weeks 2, 4, 8, 16, 24 and Follow-up (Week 30 and 36) phase. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population.|||milliliter/minute/1.73 square meters||Standard Deviation|Mean
2615471|NCT02000440|Secondary|Change From Baseline in Serum Creatinine at Indicated Time Points|Serum creatinine were assessed at Baseline (Week 0), at Weeks 2, 4, 8, 16, 24 and Follow-up (Week 30 and 36) phase. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population|||Milligram per deciliter (mg/dl)||Standard Deviation|Mean
2615472|NCT02000440|Secondary|Change From Baseline in Liver Function Parameters: Albumin and Total Protein at Indicated Time Points|Clinical chemistry parameters: albumin and total protein were assessed at Baseline (Week 0), at Weeks 2, 4, 8, 16, 24 and Follow up (Week 30 and 36) phase. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population|||Grams per liter (g/L)||Standard Deviation|Mean
2615473|NCT02000440|Secondary|Change From Baseline in Liver Function Parameters: Direct Bilirubin and Total Bilirubin at Indicated Time Points|Clinical chemistry parameters: direct bilirubin and total bilirubin were assessed at Baseline (Week 0) and at Weeks 2, 4, 8, 16 24, End of studyand Follow-up (Week 30 and 36) phase. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population|||Micromoles per liter (umol/L)||Standard Deviation|Mean
2615474|NCT02000440|Secondary|Change From Baseline in Liver Function Parameters: Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) at Indicated Time Points|Blood samples were collected at Screening (Week -4 and -2), Baseline (Week 0) and at Weeks 2, 4, 8, 16, 24 and Follow-up (Week 30 and 36) to evaluate ALT, AST, AP and GGT. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population|||International Units/liter (IU/L)||Standard Deviation|Mean
2615475|NCT02000440|Secondary|Change From Baseline in Heart Rate at Indicated Time Points|Heart rate was measured at screening, Baseline and throughout the treatment phase (Week 24) and Follow-up phase (Week 36). Heart rate measurement was repeated if the values are calculated <50 beats per minute. (bpm) or >110 bpm after the start of dosing. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population|||bpm||Standard Deviation|Mean
2615642|NCT01998906|Primary|Percentage of Participants Event Free at 1 Year||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS|||percentage of participants||95% Confidence Interval|Number
2615476|NCT02000440|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure was measured in a sitting position after 5 minutes rest with comfortably seated, legs uncrossed and the back and arm supported, such that the middle of the cuff on the upper arm is at the level of the right atrium and asked to remove all clothing that covered the location of cuff placement. It was recorded at Screening, Baseline, Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36). Vital sign measurements were repeated if the values were < 80 mmHg or > 140 mmHg SBP and <40 mmHg or >90 mmHg for DBP. Baseline was defined as the value obtained on Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36)|All Subject Population|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2615477|NCT02000440|Secondary|Number of Participants Withdrawn Due to Toxicities|Participants were monitored from start of the study treatment (Week 0) up to Week 36 for development of toxicity. Participants who developed toxicity during the period were to be withdrawn from the study.|From start of the study treatment (Week 0) until the Follow-up phase (Week 36)|All Subject Population|||Participants|||Number
2615478|NCT02000440|Secondary|Number of Participants Having Any Adverse Events (AEs), Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Participants having any AE or SAE were included in the analysis.|From start of the study treatment (Week 0) until the Follow-up phase (Week 36)|All Subject Population|||Participants|||Number
2615479|NCT02000440|Secondary|Number of Participants With Complete Proteinuria Remissions at the Indicated Time Points|Incidence of complete remissions at any time point was defined as 24 hour total protein <0.3 gram (g) per Day and maintenance of >=70 percent of Baseline eGFR throughout the treatment period. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Week 2, Week 4, Week 8, Week 16 and Week 24|Completed Treatment Population|||Participants|||Number
2615480|NCT02000440|Secondary|Percent Change From Baseline in Urinary Protein/Creatinine (Up/c) Ratio (Spot and 24 Hours [hr])|Reduction in proteinuria was measured by the Up/c ratio (spot and 24 hr) at Baseline, Week 2, 4, 8, 16, 24, end of study and at Follow-up (FU) visits Week 30 and 36. Spot urine sample was provided by the participants on site. The 24 hour urine collection started with the second morning void and ended with the first morning void on the following day; generally, 24 hour urine collection was initiated the day prior to the study visit. Baseline was defined as the value obtained at Week 0. Percent change from Baseline was calculated as change from Baseline value divided by Baseline value multiplied by 100. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, Week 30 and Week 36|All Subject Population: all eligible participants who received at least one dose of investigational drug.|||Percent change||Standard Deviation|Mean
2615481|NCT02000440|Secondary|Number of Participants Meeting the Definition of Responder for Reduction in Proteinuria at Any Time During the Treatment Phase (Week 2 to Week 24)|Proteinuria is defined as the presence of an excess of serum proteins in the urine. Participant was considered as responder on achieving >=50 percent reduction in proteinuria from Baseline (measured as 24 hour total protein) and also having a stable renal function of >=70 percent of Baseline eGFR at any time during the treatment phase of the study. Reduction in proteinuria assessment at any time during the treatment phase of the study was done by utilizing a responder analysis.|Any time during the treatment phase (Week 2 to Week 24)|Completed Treatment Population|||Participants|||Number
2615482|NCT02000440|Primary|Number of Participants Meeting the Definition of Responder for Reduction in Proteinuria at the Indicated Time Points|Proteinuria is defined as the presence of an excess of serum proteins in the urine. Participant was considered as a responder on achieving >=50 percent reduction in proteinuria from Baseline (measured as 24 hour total protein) and also having a stable renal function of >=70 percent of Baseline estimated glomerular filtration rate (eGFR) at end of treatment (>=16 Weeks). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|Week 2, Week 4, Week 8, Week 16 and Week 24|Completed Treatment Population: comprised of participants who had completed >=16 weeks of losmapimod treatment or who withdrew from the treatment. Participants who withdrew prior to Week 16 were considered as non-responders.|||Participants|||Number
2615483|NCT02000427|Secondary|Steady State Concentration of Blinatumomab||Cycle 1, day 8, 6 to 8 hours after the dose step to 28 μg/day, and Cycle 2, day 1, 6 to 8 hours after blinatumomab infusion|Participants with available serum concentration data|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2615484|NCT02000427|Secondary|Number of Participants Who Developed Anti-blinatumomab Antibodies|Anti-blinatumomab binding antibodies were evaluated with a validated blinatumomab anti-drug antibody assay with the electrochemiluminescence detection technology.|Day 29 of each treatment period and 30 days after the last dose|Participants with available post-baseline antibody results|||participants|||Number
2615485|NCT02000427|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded for severity according to the CTCAE version 4.0, where Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.~Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.~Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.~Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE. Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to blinatumomab based on response to the question: Is there a reasonable possibility that the event may have been caused by blinatumomab or other protocol-specified therapies/procedures?"|From the first dose of blinatumomab until 30 days after the last dose, up to the cut-off date of 20 May 2015; the median duration of treatment was 53.8 days.|All participants who received an infusion of blinatumomab|||participants|||Number
2615486|NCT02000427|Secondary|100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant|"The analysis of 100-day mortality after allogeneic HSCT was assessed for participants who received an allogeneic HSCT while in remission (CR/CRh*) after 2 cycles of blinatumomab treatment and did not receive any additional antileukemic treatment. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT.~The 100-day mortality rate after allogeneic HSCT was defined as the percentage of participants having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods. Participants alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive."|From the date of allogeneic HSCT until the data cut-off date of 20 May 2015; median observation time was 3.2 months.|Participants who received allogeneic HSCT and were in remission with a CR/CRh* after 2 cycles of treatment and received the transplant without receiving any additional antileukemic medication.|||percentage of participants||95% Confidence Interval|Number
2615487|NCT02000427|Secondary|Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission|Participants who achieved remission (CR/CRh*) during the first 2 cycles of treatment and received an allogeneic HSCT.|Up to the data cut-of date of 20 May 2015; Maximum duration on study was 14.5 months.|Participants who received an infusion of blinatumomab and had a CR/CRh* response during the first 2 cycles of treatment.|||percentage of participants||95% Confidence Interval|Number
2615488|NCT02000427|Secondary|Overall Survival|"Overall survival was assessed from the date the participant received the first infusion of blinatumomab until death from any cause or the date of the last follow-up.~Participants still alive at the data cut-off date were censored on the last documented visit date or the date of the last contact when the patient was last known to have been alive."|From first dose of blinatumomab until the data cut-off date; median observation time was 8.8 months.|All participants who received an infusion of blinatumomab|||months||95% Confidence Interval|Median
2615489|NCT02000427|Secondary|Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery/Complete Remission With Incomplete Hematological Recovery (CR/CRh*/CRi) During the First Two Treatment Cycles|"Efficacy was evaluated via a central bone marrow aspiration and local peripheral blood counts.~Complete remission was defined as meeting the following criteria:~less than or equal to 5% blasts in the bone marrow;~no evidence of disease;~full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1000/μl.~Complete remission with partial hematological recovery was defined as meeting the following criteria:~less than or equal to 5% blasts in the bone marrow;~no evidence of disease;~partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl.~Complete remission with incomplete hematologic recovery was defined as meeting all of the following criteria:~less than or equal to 5% blasts in the bone marrow;~no evidence of disease;~incomplete recovery of peripheral blood counts: platelets > 100,000/μl or ANC > 1000/μl.~Participants without a post-baseline disease assessment were considered non-responders."|Approximately 12 weeks, as of the data cut-off date of 20 May 2015|All participants who received an infusion of blinatumomab|||percentage of participants||95% Confidence Interval|Number
2615490|NCT02000427|Secondary|Percentage of Participants With Complete Remission With Partial Hematological Recovery (CRh*) During the First Two Treatment Cycles|"Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts.~Complete remission with partial hematological recovery (CRh*) was defined as meeting all 3 of the following criteria:~less than or equal to 5% blasts in the bone marrow;~no evidence of disease;~partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl.~Participants without a post-baseline disease assessment were considered non-responders."|Approximately 12 weeks, as of the data cut-off date of 20 May 2015|All participants who received an infusion of blinatumomab|||percentage of participants||95% Confidence Interval|Number
2615491|NCT02000427|Secondary|Percentage of Participants With Complete Remission (CR) During the First Two Treatment Cycles|"Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts.~Complete remission was defined as meeting all 3 of the following criteria:~less than or equal to 5% blasts in the bone marrow;~no evidence of disease;~full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1000/μl.~Participants without a post-baseline disease assessment were considered non-responders."|Approximately 12 weeks, as of the data cut-off date of 20 May 2015|All participants who received an infusion of blinatumomab|||percentage of participants||95% Confidence Interval|Number
2615492|NCT02000427|Secondary|Duration of CR or CRh* Response|Duration of response was measured for participants in remission (CR/CRh*), and was measured from the time the participant first achieved remission until first documented relapse or death from disease progression. Participants without a documented relapse (hematological or extramedullary) and who did not die were censored at the time of the last bone marrow assessment or the last survival follow-up visit to confirm remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death.|Up to the data cut-off date of 20 May 2015; median observation time was 7.0 months|Participants who received an infusion of blinatumomab and with a CR or CRh* response during the first 2 treatment cycles.|||months||95% Confidence Interval|Median
2615493|NCT02000427|Secondary|Percentage of Participants With Minimal Residual Disease (MRD) Remission During the First 2 Cycles of Treatment|"Bone marrow samples were evaluated for MRD remission by a central laboratory using bcr-abl fusion gene reverse transcription polymerase chain reaction (RT-PCR).~An MRD response was defined as MRD < 10^-4 measured by PCR. Participants with no post-baseline MRD assessment were considered non-responders."|Approximately 12 weeks|All participants who received an infusion of blinatumomab.|||percentage of participants||95% Confidence Interval|Number
2615515|NCT01999972|Secondary|Apparent Volume of Distribution (Vz/F) of Axitinib and Crizotinib|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15|Data for this outcome measure was not collected due to change in planned analysis.||||||
2615703|NCT01998399|Secondary|Ventilator Free Days||29 days|2 participants from each arm died during the 29 day period|||days||Full Range|Mean
2615494|NCT02000427|Primary|Percentage of Participants With Complete Remission/Complete Remission With Partial Hematological Recovery (CR/CRh*) During the First Two Treatment Cycles|"Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts.~Complete remission was defined as meeting all 3 of the following criteria:~less than or equal to 5% blasts in the bone marrow;~no evidence of disease~full recovery of peripheral blood counts: platelets > 100,000/μl, and absolute neutrophil count (ANC) > 1000/μl.~Complete remission with partial hematological recovery (CRh*) was defined as meeting all 3 of the following criteria:~less than or equal to 5% blasts in the bone marrow~no evidence of disease~partial recovery of peripheral blood counts: platelets > 50,000/μl, and ANC > 500/μl.~Participants without a post-baseline disease assessment were considered non-responders."|Approximately 12 weeks, as of the data cut-off date of 20 May 2015|All participants who received an infusion of blinatumomab.|||percentage of participants||95% Confidence Interval|Number
2615495|NCT02000180|Secondary|Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario|"Technical skills, communication skills, and global performance assessed during an integrated scenario through the JAG DOPS tool, integrated scenario communication rating form (ISCRF), and integrated scenario global rating form (ISGRF) respectively.~The JAG DOPS tool, as previously described, will be used to assess participants on integrated scenario colonoscopy cases. A change in these ratings before and after intervention is a secondary outcome.~The ISCRF and ISGRF are tools which measure communication skills and global performance with a standardized nurse and standardized patient during a simulated colonoscopy. These tools can have scores from 0-100, with higher scores representing better performance."|Immediate post-training and 4-6 weeks after training (delayed post-training)||||units on a scale||Standard Deviation|Mean
2615496|NCT02000180|Secondary|Colonoscopy Specific-performance.|The Joint Advisory Group (JAG) Direct Observation of Procedural Skills (DOPS) tool is a tool to assess colonoscopic competency and includes ratings of the following domains: (i) assessment, consent and communication; (ii) safety and sedation; (iii) endoscopic skills during insertion and withdrawal; and, (iv) diagnostic and therapeutic ability. Scores range from 0-100, with higher scores representing higher colonoscopic competency. The tool will be used to assess participants on virtual reality colonoscopy cases. A change in these ratings before and after intervention is a secondary outcome.|Pre-training, immediate post-training, and 4-6 weeks after training (delayed post-training)||||units on a scale||Standard Deviation|Mean
2615497|NCT02000180|Secondary|Cognitive Knowledge of Endoscopy|Assessed via a multiple-choice question test on the theory and practice of endoscopy. Scores range from 0-100 with higher scores representing a more knowledge of the theory and practice of endoscopy.|Pre-training, immediate post-training||||percentage score on MCQ test||Standard Deviation|Mean
2615498|NCT02000180|Primary|Difference Between Progressive and High-Fidelity Groups on Clinical Colonoscopy Peformance (JAG/DOPS)|The Joint Advisory Group (JAG) Direct Observation of Procedural Skills (DOPS) tool is a tool to assess colonoscopic competency and includes ratings of the following domains: (i) assessment, consent and communication; (ii) safety and sedation; (iii) endoscopic skills during insertion and withdrawal; and, (iv) diagnostic and therapeutic ability. Scores range from 0-100, with higher scores representing higher colonoscopic competency. The tool will be used to assess participants before and after the intervention at a time of one week. A change in these ratings before and after intervention is the primary outcome.|4-6 weeks post-intervention||||units on a scale||Standard Deviation|Mean
2615499|NCT02000154|Secondary|Cytogenetic Response|"NCA (not considered assessable)~no evidence of cytogenetic response, defined in the International Working Group 2006 response criteria for myelodysplastic syndrome."|Up to 20 weeks||||participants|||Number
2615500|NCT02000154|Secondary|Hematologic Improvement|"NCA (not considered assessable)~no evidence of hematologic improvement -erythroid, -platelet, -neutrophil, progressive disease, or relapse, defined in the International Working Group 2006 response criteria for myelodysplastic syndrome."|Up to 20 weeks||||participants|||Number
2615501|NCT02000154|Secondary|Serious Adverse Events|Total number affected any serious adverse events|Up to 20 weeks||||participants|||Number
2615502|NCT02000154|Secondary|Disease Response Assessment|"Disease progression~According to the International Working Group 2006 response criteria for Myelodysplastic Syndrome, disease progression is defined as no evidence of complete remission (CR), partial remission, marrow CR, stable disease, or failure, and as meeting one of the following conditions.~when pretreatment percentage of bone marrow blasts < 5%: ≥ 50% increase to > 5%.~when pretreatment percentage of bone marrow blasts 5 to 10%: ≥ 50% increase to > 10%.~when pretreatment percentage of bone marrow blasts 10 to 20%: ≥ 50% increase to > 20%.~when pretreatment percentage of bone marrow blasts 20 to 30%: ≥ 50% increase to > 30%.~other: at least one of the following: decrease to ≤ 50% of neutrophil or platelet count at maximum response, ≥ 2 g/dL decrease in Hgb or transfusion dependence (in the absence of other factors, such as infection, gastrointestinal bleeding, or hemolysis)."|Up to 20 weeks||||participants|||Number
2615503|NCT02000154|Primary|Adverse Events|Total number affected by any adverse events (details are presented in adverse event section)|Up to 20 weeks||||participants|||Number
2615504|NCT01999985|Secondary|Median Progression Free Survival|Estimate the 6-month progression free survival (PFS) rate in participants with acquired EGFR resistance. Response Criteria for Phase 1B will follow RECIST v.1.1: Progressive Disease (PD) is defined as at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Up to 6 Months|All Participants who received treatment|||months||95% Confidence Interval|Median
2615505|NCT01999985|Secondary|Number of Participants With Objective Response|Estimates objective response rate (complete response [CR] and partial response [PR]) in participants with acquired EGFR resistance|Up to 6 Months|All Participants who received treatment.|||participants|||Number
2615506|NCT01999985|Primary|Maximum Tolerated Dose (MTD) of Afatinib (BIBW 2992) in Combination With Dasatinib|"The MTD for this combined treatment will be defined as either:~The highest dosage cohort in which six patients had been treated and there were less than two dose limiting toxicities (DLTs) or,~Afatinib at the highest tolerated dose investigated (40 mg by mouth [PO] daily) plus dasatinib at the highest tolerated dose investigated (cohort 3, 140 mg PO daily)."|Up to 6 Months|All participants who received at least one dose of Afatinib and Dasatinib.|||mg|||Number
2615507|NCT01999972|Secondary|Dose Expansion Part Cohort 1: Ratio of Serum Soluble Protein Biomarkers Level to Baseline Biomarkers Level by Each Timepoint|Serum soluble protein biomarkers included angiopoietin-2, Hepatocyte Growth Factor (HGF), Vascular Endothelial Growth Factor Receptor 3 (VEGFR3). Ratio=value of serum soluble protein biomarkers at each time point to the value at baseline. Biomarker analysis was not planned to be performed in dose escalation part and Cohort 2 of dose expansion part, as pre-specified in protocol.|Baseline, Cycle 2 Day 1, end of treatment (up to 33 cycles in Part 1 and 17 cycles in Part 2, each cycle 28 days)|Serum soluble protein biomarker analysis set: all enrolled participants who received at least 1 dose of any study drug, had at least 1 biomarker parameter from corresponding assay sample with at least 1 baseline biomarker measurement. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||ratio||Standard Deviation|Mean
2615508|NCT01999972|Secondary|Dose Expansion Part Cohort 1: Level of Plasma Soluble Protein Biomarker (c-MET)|Plasma soluble protein biomarker included c-MET. Biomarker analysis was not planned to be performed in dose escalation part and Cohort 2 of dose expansion part, as pre-specified in protocol.|Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 3, 5; end of treatment (up to 33 cycles in Part 1 and 17 cycles in Part 2, each cycle 28 days)|Plasma soluble protein biomarker analysis set included all enrolled participants who received at least one dose of any study drug, and had at least one biomarker parameter from the corresponding assay sample with at least one baseline biomarker measurement.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2615509|NCT01999972|Secondary|Dose Expansion Part Cohort 1: Percentage of c-MET Positive Tumor Cell at Baseline in Relation to Objective Response Rate (ORR)|Percentage of c-MET positive tumor cell for objective response (complete response [CR] + partial response [PR]) is reported. Objective response was defined as CR and PR. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. Biomarker analysis was not planned to be performed in dose escalation part and Cohort 2 of dose expansion part, as pre-specified in protocol.|Baseline|Tumor Immunohistochemistry (IHC) analysis set included all enrolled participants who received at least one dose of any study drug, and had at least one biomarker parameter from the corresponding assay sample with at least one baseline biomarker measurement, and had confirmed objective response (CR+PR).|||percentage of positive tumor cells||Standard Deviation|Mean
2615510|NCT01999972|Secondary|Dose Expansion Part Cohort 1: Change From Baseline in Serum Concentration of Circulating microRNAs (miRNA) at End of Treatment||Baseline, end of treatment (up to 33 cycles in Part 1 and 17 cycles in Part 2, each cycle 28 days)|This outcome measure was not analyzed because of a change in planned analysis, due to the lack of strong evidence available supporting testing a hypothesis in the small sample set.||||||
2615511|NCT01999972|Secondary|Dose Expansion Part Cohort 1: Levels of Serum Soluble Protein Biomarkers|Serum soluble protein biomarkers included angiopoeitin-2, Hepatocyte Growth Factor (HGF), Vascular Endothelial Growth Factor Receptor 3 (VEGFR 3). Biomarker analysis was not planned to be performed in dose escalation part and Cohort 2 of dose expansion part, as pre-specified in protocol.|Baseline, Cycle 2 Day 1, end of treatment (up to 33 cycles in Part 1 and 17 cycles in Part 2, each cycle 28 days)|Serum soluble protein biomarker analysis set included all enrolled participants who received at least one dose of any study drug, and had at least one biomarker parameter from the corresponding assay sample with at least one baseline biomarker measurement.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2615512|NCT01999972|Secondary|Dose Expansion Part: Progression-Free Survival (PFS)|PFS (as per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) was defined as the time (in months) from start of study treatment to first documentation of objective tumor progression or death due to any cause, whichever occurred first. PFS (in months) was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44. Progression was defined as >= 20 percent increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions. PFS was not estimated in Dose Expansion Cohort 2 due to small sample size.|From Baseline until disease progression or death, whichever occurred first (up to 33 cycles in Part 1 and 17 cycles in Part 2, each cycle 28 days)|Response-evaluable analysis set included all participants who received at least 1 dose of axitinib and crizotinib and had an adequate baseline tumor assessment.|||months||95% Confidence Interval|Median
2615513|NCT01999972|Secondary|Dose Expansion Part: Duration of Response|Duration of response (as per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) was defined as the time (in months) from first documentation of objective tumor response (complete response [CR] or partial response [PR]) until the first date that recurrent, progressive disease, or death (whichever occurred first). CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. Progression was defined as >= 20 percent increase in sum of longest diameter of target lesions; measurable increase in non-target lesion; appearance of new lesions.|From first objective response until first recurrent, disease progression, or death, whichever occurred first (up to 33 cycles in Part 1 and 17 cycles in Part 2, each cycle 28 days)|Subset of response evaluable analysis set included all participants with overall objective response of CR or PR who received at least 1 dose of axitinib and crizotinib and had baseline tumor assessment.|||months||95% Confidence Interval|Median
2615514|NCT01999972|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based on assessment of confirmed complete response [CR] or confirmed partial response [PR] according to Response Evaluation Criteria In Solid Tumors [RECIST] version1.1 were reported. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.|From Baseline until disease progression or death, whichever occurred first (up to 33 cycles in Part 1 and 17 cycles in Part 2, each cycle 28 days)|Response-evaluable analysis set included all participants who received at least 1 dose of axitinib and crizotinib and had an adequate baseline tumor assessment.|||percentage of participants||95% Confidence Interval|Number
2615516|NCT01999972|Secondary|Apparent Oral Clearance (CL/F) of Axitinib and Crizotinib|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent oral clearance was obtained by dividing study drug dose with AUCtau, where AUCtau was area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval. Data of this outcome measure was not planned to be analyzed for Cohort 2 in dose expansion part, as pre-specified in protocol.|Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15|The PK parameter analysis population was defined as all treated participants who had at least 1 of the PK parameters of interest of any of the study drugs.|||liters per hour||Geometric Coefficient of Variation|Geometric Mean
2615517|NCT01999972|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Axitinib and Crizotinib|Area under the plasma concentration versus time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 12 hours. Data of this outcome measure was not planned to be analyzed for Cohort 2 in dose expansion part, as pre-specified in protocol.|Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15|The PK parameter analysis population was defined as all treated participants who had at least 1 of the PK parameters of interest of any of the study drugs.|||nanogram*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2615518|NCT01999972|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib and Crizotinib|Data of this outcome measure was not planned to be analyzed for Cohort 2 in dose expansion part, as pre-specified in protocol.|Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15|The PK parameter analysis population was defined as all treated participants who had at least 1 of the PK parameters of interest of any of the study drugs.|||hours||Full Range|Median
2615519|NCT01999972|Secondary|Maximum Observed Plasma Concentration (Cmax) of Axitinib and Crizotinib|Data of this outcome measure was not planned to be analyzed for Cohort 2 in dose expansion part, as pre-specified in protocol.|Axitinib: Pre-dose (0 hour [hr]), 1, 2, 3, 4, 6, 8 hrs post-dose at Lead-in Day 7, Cycle 1 Day 15; Crizotinib: pre-dose (0 hr), 1, 2, 3, 4, 6, 8 hrs post-dose at Cycle 1 Day 15|Pharmacokinetic (PK) parameter analysis population was defined as all treated participants who had at least 1 of the PK parameters of interest of any of the study drugs.|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2615520|NCT01999972|Secondary|Number of Participants With Maximum Change From Baseline in QTc Interval|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Number of participants with maximum increase from baseline of less than (<) 30 milliseconds (msec), 30 to <60 msec and greater than or equal to (>=) 60 msec were reported.|Baseline, End of Treatment (up to Cycle 33 [for Part 1] and up to Cycle 17 [for Part 2])|Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib.|||participants|||Number
2615521|NCT01999972|Secondary|Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG-PS) to Worst Value|ECOG-PS: used to assess how disease affected the daily living abilities of participant. It ranges on the scale from: 0-5 (0=fully active/able to carry on all pre-disease activities without restriction;1=restricted in physically strenuous activity but ambulatory/able to carry out light/sedentary work;2=ambulatory [for more than (>)50%of waking hours], capable of all self-care but unable to carry out any work activities;3=capable of limited self-care, confined to bed or chair [for >50% of waking hours];4=completely disabled, not capable of any self-care, totally confined to bed or chair;5= dead, higher score=more functional impairment) and changes to worst status scores were presented. Baseline value=value collected prior to first dose of study drug on Cycle 1 Day 1. Worst post-baseline value=worst value between first dose of any study drug and end of treatment (EOT) visit. Shift to low refers to lower than Baseline value; shift to high refers to higher than baseline value for ECOG-PS.|Baseline, End of Treatment (up to Cycle 33 [for Part 1] and up to Cycle 17 [for Part 2])|Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib.|||participants|||Number
2615522|NCT01999972|Secondary|Change From Baseline in Body Weight at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment||Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (any time up to a maximum duration of 33 cycles in Part 1 and 17 cycles in Part 2)|Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, '0’ in the “number analyzed” field signifies that none of the participant were evaluable at specified time point.|||kilograms (kg)||Standard Deviation|Mean
2615523|NCT01999972|Secondary|Change From Baseline in Pulse Rate at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment||Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (any time up to a maximum duration of 33 cycles in Part 1 and 17 cycles in Part 2)|Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, '0’ in the “number analyzed” field signifies that none of the participant were evaluable at specified time point.|||beats per minute (bpm)||Standard Deviation|Mean
2615524|NCT01999972|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, 15 of Cycle 1, Day 1 of Cycles 2, 4, 6, 12, 24 and End of Treatment Visit||Baseline; Day 1 and 15 of Cycle 1; Day 1 of Cycles 2, 4, 6, 12, 24; and end of treatment (up to a maximum duration of 33 cycles in Part 1 and 17 cycles in Part 2, each cycle 28 days)|Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, '0’ in the “number analyzed” field signifies that none of the participant were evaluable at specified time point.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2615643|NCT01998906|Primary|Event-Free Survival|The median time, in months, between randomization and date of documented occurrence of an EFS event.|BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS|||months||95% Confidence Interval|Median
2615525|NCT01999972|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Biochemistry Test Abnormalities|Laboratory parameters included hematological and biochemistry parameters. Biochemistry parameters/abnormalities included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia. Number of participants with biochemistry test abnormalities by grades (NCI CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.|Baseline up to end of treatment (up to 33 cycles in Part 1 and 17 cycles in Part 2, each cycle 28 days)|"Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||participants|||Number
2615526|NCT01999972|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities Based on National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03: Hematological Test Abnormalities|Laboratory parameters included hematological and biochemistry parameters. Hematological parameters included haemoglobin (anemia, haemoglobin increased), lymphocytes (lymphopenia), neutrophils, platelets and white blood cells. Number of participants with hematological abnormalities by grades (as per NCI CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.|Baseline up to end of treatment (up to 33 cycles in Part 1 and 17 cycles in Part 2, each cycle 28 days)|"Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||participants|||Number
2615527|NCT01999972|Secondary|Number of Participants With Grade 3 or Higher Adverse Events (AEs) as Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 4.03|An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 3 (severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events between first dose of study drug and until 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|First dose of study drug until 28 days after last dose (up to 33 cycles in Part 1 and 17 cycles in Part 2, each cycle 28 days)|Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib.|||participants|||Number
2615528|NCT01999972|Secondary|Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and until 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|First dose of study drug until 28 days after last dose (up to 33 cycles in Part 1 and 17 cycles in Part 2, each cycle 28 days)|Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib.|||participants|||Number
2615529|NCT01999972|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and until 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|First dose of study drug until 28 days after last dose (up to 33 cycles in Part 1 and 17 cycles in Part 2, each cycle 28 days)|Safety analysis set included all enrolled participants who received at least 1 dose of axitinib or crizotinib.|||participants|||Number
2615530|NCT01999972|Primary|Dose-Escalation Part: Number of Participants With Dose-Limiting Toxicities (DLTs)|Toxicity as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03. DLT defined as any following events attributable to any (axitinb or crizotinib) or both agents in combination: hematologic (Grade 4 neutropenia, absolute neutrophil count<1000/mm^3 with single temperature of >38.3 degrees celsius or sustained temperature of 38 degrees celcius for >1 hour; >=Grade 3 neutropenic infection; >=Grade 3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia), non-hematologic (>=Grade 3 toxicities [except asymptomatic hypophosphatemia, hyperuricemia without signs, symptoms of gout, and tumor lysis syndrome], nausea, vomiting or diarrhea persisted at Grade 3 or 4 despite maximal medical therapy; Grade 3 hypertension if persistent despite anti-hypertensives); In asymptomatic participant, Grade 3 QTc prolongation (QTc>=501 msec) if persisted after correcting reversible causes, and failure to deliver >=75 percent (%) of dose of each study drug.|Cycle 1 (28 days)|Per protocol analysis set:all enrolled participants who received at least 1 dose of study drug, experienced either DLT during first cycle,or completed first cycle observation period.Participants who lost to follow up before receiving at least 75% of planned first cycle dose due to reasons other than treatment-related AEs were not evaluable for DLT.|||Participants|||Count of Participants
2615531|NCT01999920|Secondary|Change From Baseline on Adult Separation Anxiety - 27 Scale|Measure Description: (15 min) Adult Separation Anxiety - 27 Scale 27 items pertaining to adult separation anxiety, each self-rated on a four-point scale, 0=best, 3=worse. Minimum Total Score=0 (better); Maximum Total Score = 81 (worse)|Up to 12 weeks||||units on a scale||Standard Deviation|Mean
2615644|NCT01998906|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|OS was defined as the time from the date of randomization to the date of the death due to any cause.|BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS|||percentage of participants|||Number
2615532|NCT01999920|Secondary|Change From Baseline on Structured Clinical Interview for Separation Anxiety Disorder|The Structured Clinical Interview for Separation Anxiety Disorder was modified for DSM-5. The eight separation anxiety disorder criteria are rated for both childhood (rated at baseline only) and past week time frames, scored as 0 (not at all), 1 (sometimes), 2 (often) or ? (don't recall). In keeping with the DSM-5 guidelines, endorsement of three or more of the eight criterion symptoms (symptoms rated as '2' or 'often') is used as a threshold to determine categorical (yes/no) diagnosis of separation anxiety disorder. Scores on each of the eight items are also summed to produce a continuous measure of separation anxiety symptoms experienced during childhood and adulthood (range for each scale=0-16).|Baseline and week 12||||units on a scale||Standard Deviation|Mean
2615533|NCT01999920|Secondary|Change From Baseline in Quality of Life Enjoyment & Satisfaction Questionnaire|Measure Description: (10 min) Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q, Endicott et al, 1993): self-rated assessment of quality of life. 16 items related to life quality, each rated on a score of 1 (very poor) to 5 (very good), with a minimum total score of 16, and a maximum total score of 80.|Up to 12 weeks||||units on a scale||Standard Deviation|Mean
2615534|NCT01999920|Secondary|Change From Baseline in Attachment Style Questionnaire Score|Measure Description: (15 min) Attachment Style Questionnaire (Feeney at al., 1994) 40 items relating to quality of adult relationships. Questionnaire includes questions concerning Confidence (8 items, minimum score=8, maximum score=48), Discomfort (10 items, minimum score=10, maximum score=60), Relationships as Secondary (7 items, minimum score=7, maximum score=42), Need for Approval (7 items, minimum score=7, maximum score =42), and Preoccupation with Relationships (8 items, minimum score = 8, maximum score=48), each self-rated on a six-point scale, each self-rated from 1 (totally disagree) to 6 (totally agree).|Up to 12 weeks||||units on a scale||Standard Deviation|Mean
2615535|NCT01999920|Secondary|Change From Baseline Hamilton Rating Scale for Depression 17-item Total Score|This standard scale will be used to assess severity of depression, looking at change in total score from baseline to week 12, rating severity of depression on a scale from 0 (least depression) to 50 (greatest depression).|Up to 12 weeks||||units on a scale||Standard Deviation|Mean
2615536|NCT01999920|Primary|Clinical Global Impression-Improvement Scale|"Clinical Global Impression-Improvement Scale rating at week 12 A quickly administered and widely used observer rating, with ratings from 1 (very much improved) to 7 (very much worse). Responder is a score of 1 or 2."|Up to 12 weeks||||Participants|||Count of Participants
2615537|NCT01999894|Primary|Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE)|Number of patients who experienced one or more TEAEs during the study|From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48)|The Safety Population consists of 102 enrolled patients who received at least one dose of study drug.|||participants|||Number
2615538|NCT01999868|Secondary|Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Post-Randomization)|Number of adverse events (AEs) that occurred during the post-randomization phase (Week 12 to 100), classified by severity and type. AEs were classified by grade according to the National Cancer Institute's (NCI's) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03, and all Grade 2 or greater AEs were collected in the database. In addition, new onset or worsening psoriatic arthritis was separately collected and graded from 1 to 3 along a study-specific functional scale. AEs were also classified based on relatedness to study drug, whether they led to study drug discontinuation, and whether they were AEs of special interest as specified in the protocol. AEs that started prior to randomization but became serious after randomization were included in the counts for the post-randomization time period.|From randomization (Week 12) to last safety follow-up visit (up to Week 100)|The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.|||Number of Events|||Number
2615539|NCT01999868|Secondary|Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Post-Randomization)|Number of participants who experienced adverse events (AEs) during the post-randomization phase (Week 12 to 100), classified by severity and type. AEs were classified by grade according to the National Cancer Institute's (NCI's) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03, and all Grade 2 or greater AEs were collected in the database. In addition, new onset or worsening psoriatic arthritis was separately collected and graded from 1 to 3 along a study-specific functional scale. AEs were also classified based on relatedness to study drug, whether they led to study drug discontinuation, and whether they were AEs of special interest as specified in the protocol. AEs that started prior to randomization but became serious after randomization were included in the counts for the post-randomization time period.|From randomization (Week 12) to last safety follow-up visit (up to Week 100)|The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.|||Number of participants|||Number
2615540|NCT01999868|Secondary|Frequency and Severity of Adverse Events and Serious Adverse Events (By Event, Lead-in Phase)|Number of adverse events (AEs) that occurred during the lead-in phase (Week 0 to 12), classified by severity and type. AEs were classified by grade according to the National Cancer Institute's (NCI's) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03, and all Grade 2 or greater AEs were collected in the database. In addition, new onset or worsening psoriatic arthritis was separately collected and graded from 1 to 3 along a study-specific functional scale. AEs were also classified based on relatedness to study drug, whether they led to study drug discontinuation, and whether they were AEs of special interest as specified in the protocol.|Lead-In Phase (Week 0 to 12)|The safety population includes all participants who received at least one dose of treatment after enrollment.|||Number of Events|||Number
2615541|NCT01999868|Secondary|Frequency and Severity of Adverse Events and Serious Adverse Events (By Participant, Lead-in Phase)|Number of participants who experienced adverse events (AEs) during the lead-in phase (Week 0 to 12), classified by severity and type. AEs were classified by grade according to the National Cancer Institute's (NCI's) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03, and all Grade 2 or greater AEs were collected in the database. In addition, new onset or worsening psoriatic arthritis was separately collected and graded from 1 to 3 along a study-specific functional scale. AEs were also classified based on relatedness to study drug, whether they led to study drug discontinuation, and whether they were AEs of special interest as specified in the protocol.|Lead-In Phase (Week 0 to 12)|The safety population includes all participants who received at least one dose of treatment after enrollment.|||Number of participants|||Number
2615542|NCT01999868|Secondary|Change in Dermatology Life Quality Index (DLQI)|Change in the Dermatology Life Quality Index (DLQI) score from Week 12 to the specified post-randomization time point. DLQI is a 10-question, participant-reported questionnaire that assesses quality of life with respect to skin conditions in the areas of symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Each question measures the level of effect that the skin condition has on quality of life, and responses range from 'Not at all' (score = 0) to 'Very much' (score = 3). The overall score is the sum of the scores for all 10 questions and ranges from 0-30, with higher scores indicating worse quality of life.|Week 40, Week 88|The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.|||Units on a Scale||Standard Deviation|Mean
2615543|NCT01999868|Secondary|Percentage of Participants Who Were Cleared or Minimal in the Physician's Global Assessment (PGA)|"Percentage of participants who were classified as cleared or minimal in the Physician's Global Assessment (PGA) average score at the specified post-randomization time point. The PGA assesses the severity of the psoriasis in 3 components: induration, erythema and scaling. Each component is given a score ranging from 0 to 5 based on the majority of the participant's psoriasis lesions, with higher scores indicating worse disease. A PGA average score < 1.5 was classified as cleared or minimal."|Week 40, Week 88|The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.|||percentage of participants|||Number
2615544|NCT01999868|Secondary|Time to Psoriasis Relapse (Treating Drop-Outs as Censored)|Time in weeks from Week 12 to psoriasis relapse. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12. This occurs if the participant obtains a PASI score at any evaluation during the specified time interval that is ≥ Week 12 PASI + [(Baseline PASI -Week 12 PASI)/2]). Participants who terminated early from the study due to reasons other than psoriasis relapse or worsening psoriasis (drop-outs) were censored at the time of drop-out. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).|Post-randomization (Week 12 to 88)|The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.|||weeks||95% Confidence Interval|Median
2615545|NCT01999868|Secondary|Time to Psoriasis Relapse (Treating Drop-Outs as Relapse)|Time in weeks from Week 12 to psoriasis relapse. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12. This occurs if the participant obtains a PASI score at any evaluation during the specified time interval that is ≥ Week 12 PASI + [(Baseline PASI -Week 12 PASI)/2]). Participants who terminated early from the study (drop-outs) were considered to have experienced relapse at time of drop-out. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).|Post-randomization (Week 12 to 88)|The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.|||weeks||95% Confidence Interval|Median
2615546|NCT01999868|Secondary|Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Missing Relapse Status)|The percentage of participants who experienced psoriasis relapse in the interval from Week 12 to 88. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12 (Baseline PASI -Week 12 PASI). Participants who terminated early due to reasons other than psoriasis relapse or worsening psoriasis were considered to have a missing relapse status at time of drop-out and were excluded from the analyses. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).|Post-randomization (Week 12 to 88)|The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.|||percentage of participants|||Number
2615547|NCT01999868|Secondary|Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as No Relapse)|The percentage of participants who experienced psoriasis relapse in the interval from Week 12 to 88. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12 (Baseline PASI -Week 12 PASI). Participants who terminated early from the study due to reasons other than psoriasis relapse or worsening psoriasis (drop-outs) were considered to have not experienced relapse at time of drop-out. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).|Post-randomization (Week 12 to 88)|The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.|||percentage of participants|||Number
2615571|NCT01999322|Primary|Number of Microscopically Confirmed Episodes of Infusion Set Occlusions|The number of microscopically confirmed episodes of infusion set occlusions during 6 weeks of treatment. Episodes of infusion set occlusions were confirmed by microscopic examination of the infusion sets at each routine weekly visit and infusion sets that had been changed prematurely because of leakage, unexplained hyperglycaemia or suspicion of occlusion (observation of a plug).|During 6 weeks of treatment|FAS: included all randomised subjects. In exceptional cases subjects could be excluded from the full analysis set. In such cases the reason for exclusion was to be justified and documented. Subjects in the full analysis set contribute to the evaluation “as randomised”.|||Episodes|||Number
2615548|NCT01999868|Primary|Percentage of Participants Who Experienced Psoriasis Relapse (Treating Drop-Outs as Relapse)|The percentage of participants who experienced psoriasis relapse in the interval from Week 12 to 88. Psoriasis relapse is defined as loss of ≥ 50% of the initial Psoriasis Area and Severity Index (PASI) improvement measured at Week 12. This occurs if the participant obtains a PASI score at any evaluation during the specified time interval that is ≥ Week 12 PASI + [(Baseline PASI -Week 12 PASI)/2]). Participants who terminated early from the study (drop-outs) were considered to have experienced relapse at time of drop-out. PASI is an assessment for psoriasis severity based on 4 body areas: Head and Neck, Upper Extremities, Trunk, and Lower Extremities. Psoriasis severity within each body area is assessed for Redness (score 0-4), Thickness (score 0-4) and Scaling (score 0-4). Scores for each body area are summed and weighted by the affected Body Surface Area (score 0-6) to produce the total score. The score ranges from 0 (no psoriasis present) to 72 (very severe psoriasis).|Post-randomization (Week 12 to 88)|The intent-to-treat population includes all participants who were found to be eligible after the 12-week lead-in period and underwent random assignment.|||percentage of participants|||Number
2615549|NCT01999777|Secondary|Time to First Seizure Following Treatment (TFSFT)|Time to first seizure following treatment was defined as time from treatment with study drug to the onset of the next seizure, rescue intervention (for acute central respiratory depression AE) to maintain subject safety, alterations to background AED therapy, early termination, or 6 hours, whichever came first.|6 hours|Intent-to-treat|||hours||95% Confidence Interval|Median
2615550|NCT01999777|Primary|Number of Participants That Were Seizure-free|"A participant was considered seizure-free if he or she completed the 6-hour Treatment Phase without seizures recorded, premature discontinuation of study drug, rescue intervention for acute central respiratory depression adverse event (AE), and alterations to background anti-epileptic drug (AED) therapy. Otherwise, the participant was included in the analysis for seizure-free events with the outcome of seizure."|6 hours|Intent to treat|||Participants|||Count of Participants
2615551|NCT01999530|Primary|Changes in [11C]-(+)-PHNO Binding (Measured as Binding Potential) in Dorsal Caudate (DC)|Binding potential (an estimate of the ratio of Bmax/kd) was measured by positron emission tomography to determine if taking prazosin alters the amount of tracer bound to receptors. A negative change in binding potential means a decrease in binding potential and a positive change in binding potential represents an increase. Bmax is the total density of receptors. kd is the affinity of a drug for the target|3 weeks after taking prazosin||||binding potential||Full Range|Mean
2615552|NCT01999517|Primary|Change in GFR|The primary endpoint for this trial will be to determine the change in glomerular filtration rate after exposure to contrast media. We will compare the change in GFR before and after PCI of the group that received intravenous nitroglycerin with the change in GFR before and after PCI of the group that did not receive intravenous nitroglycerin.|Baseline and 48 to 72 hours post-PCI||||mL/min||Inter-Quartile Range|Median
2615553|NCT01999465|Other Pre-specified|Change From Baseline in Participant's Current Therapy|Parents will complete a survey asking participant's current therapy program, including therapy type, setting, frequency, duration, other treatment activities, splint usage, home range of motion exercise program and its frequency and duration at initial and monthly follow-up visits. The purpose of this survey is to help us understand whether there are potential confounders that could affect the study result.|Baseline to 3-month.|||||||
2615554|NCT01999465|Other Pre-specified|Change From Baseline in Spontaneous Hand-to-Mouth Movement|Study coordinators will conduct one-minute video recording with patient in supported sitting position in a chair or seated on parents lap at initial and monthly clinic visits. A toy, pacifier, or bottle will be provided to trigger patient's spontaneous hand-to-mouth movement. The frequency of hand to mouth motion will be recorded and separated out as to the positioning of the elbow. We are evaluating the motion to determine if the motion of the elbow flexion is against gravity, (the arm held at the side of the body or in an adducted position) or in gravity-eliminated position, (the arm held away from the body or in an abducted position). We are looking at the strength of the biceps in its ability to lift the arm against gravity during functional hand to mouth activities. The NMES unit will not be in use during the videotaping process; we are looking at the spontaneous movement of the extremity.|Baseline to 3-month.|||||||
2615555|NCT01999465|Primary|Change From Baseline in Upper Extremity Range of Motion|One of the two-blinded occupational therapists will assess the active range of motion (AROM) of elbow flexion using goniometer at enrollment and 3-month follow-up clinic visit. The minimum degree is 0 and the maximum degree is 150; the higher degree means better outcome. We will then examine the change of elbow flexion active range of motion (AROM) from baseline to 3-month.|Baseline to 3-month.|One in the Standard NMES cohort was lost of follow-up and two in the sham cohort were lost of follow-up at 3 months.|||degree||Standard Deviation|Mean
2615556|NCT01999465|Primary|Change From Baseline in Upper Extremity Muscle Strength|One of the two-blinded occupational therapists will conduct the evaluation at enrollment and 3-month follow-up clinic visit. In this study, we will evaluate the biceps strength using the British Medical Research Council (MRC) grading system. The British Medical Research Council (MRC) grading system for muscle strength is based on a scale from 0 (minimum score, not testable), 1, 2, 3, 4, to 5 (maximum score, normal strength); higher score means better outcome. British Medical Research Council (MRC) grade 2 or higher is functional in terms of muscle power. In current study, we will examine the change of biceps British Medical Research Council (MRC) grade from baseline to 3-month.|Baseline to 3-month.|One in the Standard NMES cohort was lost of follow-up and two in the sham cohort were lost of follow-up at 3 months.|||score on a scale||Full Range|Median
2615557|NCT01999400|Secondary|The AUC of Metabolite (N-acetyl-mesalamine) in Distal Jejunum|The AUC is the area under the concentration-time curve from time 0 to 7 hours. The data are organized by the different drug formulations of mesalamine, which include Pentasa, Apriso, and Lialda. The AUC is measured in units of micromoles of mesalamine per liter of plasma (µM) multiplied by time in hours (µM*h).The AUC results are reported over the time-period because this provides a more meaningful comparison of potential differences in the bioequivalence of formulations. The solution formulation (Delzicol) was not administered in this portion of the study. Therefore no results pertaining to the solution formulation are included in this outcome measure.|0 hours pre-dose and up to 7 hours post-dose|The number of subjects that were administered Pentasa, Apriso, Lialda were 10, 7, and 9, respectively. However, we were only able to collect gastrointestinal fluid from the distal jejunum for only 3 subjects in each of these arms due to the placement of the gastrointestinal tube.|||uM*h||Standard Deviation|Mean
2615558|NCT01999400|Secondary|The AUC of Mesalamine in Distal Jejunum|The AUC is the area under the concentration-time curve from time 0 to 7 hours. The data are organized by the different drug formulations of mesalamine, which include Pentasa, Apriso, and Lialda. The AUC is measured in units of micromoles of mesalamine per liter of plasma (µM) multiplied by time in hours (µM*h).The AUC results are reported over the time-period because this provides a more meaningful comparison of potential differences in the bioequivalence of formulations. The solution formulation (Delzicol) was not administered in this portion of the study. Therefore no results pertaining to the solution formulation are included in this outcome measure.|0 hours pre-dose and up to 7 hours post-dose|The number of subjects that were administered Pentasa, Apriso, Lialda were 10, 7, and 9, respectively. However, we were only able to collect gastrointestinal fluid from the distal jejunum for only 3 subjects in each of these arms due to the placement of the gastrointestinal tube.|||uM*h||Standard Deviation|Mean
2615559|NCT01999400|Primary|The AUC of Metabolite (N-acetyl-mesalamine) in Plasma|The AUC is the area under the concentration-time curve from time 0 to last time point. The data are organized by the different drug formulations of mesalamine, which include Pentasa (0 to 72 hours), Apriso (0 to 72 hours), Lialda (0 to 96 hours), and Delzicol (0 to 24 hours). The AUC is measured in units of nanomoles of N-acetyl-mesalamine per liter of plasma (nM) multiplied by time in hours (nM*h). The AUC results are reported over the time-period because this provides a more meaningful comparison of potential differences in the bioequivalence of formulations.|0 hours pre-dose and up to 96 hours post-dose||||nM*h||Standard Deviation|Mean
2615560|NCT01999400|Primary|The AUC of Mesalamine in Plasma|The AUC is the area under the concentration-time curve from time 0 to last time point. The data are organized by the different drug formulations of mesalamine, which include Pentasa (0 to 72 hours), Apriso (0 to 72 hours), Lialda (0 to 96 hours), and Delzicol (0 to 24 hours). The AUC is measured in units of nanomoles of mesalamine per liter of plasma (nM) multiplied by time in hours (nM*h). The AUC results are reported over the time-period because this provides a more meaningful comparison of potential differences in the bioequivalence of formulations.|0 hours pre-dose and up to 96 hours post-dose||||nM*h||Standard Deviation|Mean
2615561|NCT01999348|Secondary|Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale|The physician assessed patient compliance with Ganfort® UD compared to previous treatment using a 3-point scale where: 1=better (best), 2=equal and 3=worse. The number of participants in each category is reported.|Final Visit (Week 8 to 12)|All participants from the Per-protocol population, all treated participants who had no major protocol violations, who received previous treatment.|||participants|||Number
2615562|NCT01999348|Secondary|Percentage of Patients Prescribed by the Physician to Continue Treatment|The percentage of participants who continued treatment with Ganfort® UD after Week 12.|Final Visit (Week 8 to 12)|Per-protocol population included all treated participants who had no major protocol violations.|||percentage of participants|||Number
2615563|NCT01999348|Secondary|Percentage of Patients Who Discontinued Treatment|The percentage of participants who discontinued treatment with Ganfort® UD up to the Week 12 Final Visit|12 Weeks|Per-protocol population included all treated participants who had no major protocol violations.|||percentage of participants|||Number
2615564|NCT01999348|Secondary|Physician Assessment of Tolerability on a 4-Point Scale|The physician assessed the patient's tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported.|Final Visit (Week 8 to 12)|Per-protocol population included all treated participants who had no major protocol violations.|||participants|||Number
2615565|NCT01999348|Secondary|Patient Assessment of Tolerability on a 4-Point Scale|The patient assessed the tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported.|Final Visit (Week 8 to 12)|Per-protocol population included all treated participants who had no major protocol violations.|||participants|||Number
2615566|NCT01999348|Secondary|Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale|The physician assessed the effectiveness of Ganfort® UD with regard to IOP changes from Baseline using a 3-point scale where: 1=Better than expected (best), 2=As expected and 3=Worse than expected. The number of participants in each category is reported.|Baseline, Final Visit (Week 8 to 12)|Per-protocol population included all treated participants who had no major protocol violations.|||participants|||Number
2615567|NCT01999348|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measure of the fluid pressure inside the study eye. A result at the Final Visit that is lower than the result at Baseline indicates a reduction in IOP (improvement).|Baseline, Final Visit (Week 8 to 12)|Participants from the Per-protocol population, all treated participants who had no major protocol violations, with complete data available at Baseline and Final Visit for analyses.|||mmHg||Standard Deviation|Mean
2615568|NCT01999322|Secondary|Number of Premature Infusion Set Changes|"A premature infusion set change was defined as not being a routine change. This was defined as an infusion set changed at home due to suspicion of occlusion, leakage, unexplained hyperglycaemic episode, infusion site reaction, technical reason, or other. The change of infusion set at a site visit was considered a routine change unless an occlusion was actually suspected at the site."|During 6 weeks of treatment||||Episodes|||Number
2615569|NCT01999322|Secondary|Number of Episodes of Possible Infusion Set Occlusions|Episodes of possible infusion set occlusions were defined as infusion sets changed due to suspicion of occlusion, leakage or unexplained hyperglycaemic episode. Possible occlusion excluded technical reasons. This endpoint was calculated from the recorded date/times of changes of infusion set combined with the subjects' own assessment.|During 6 weeks of treatment||||Episodes|||Number
2615570|NCT01999322|Secondary|Number of Unexplained Episodes of Hyperglycaemia (Confirmed by Self-measured Plasma Glucose (SMPG))|Unexplained hyperglycaemia was defined as a confirmed plasma glucose value ≥ 16.7 mmol/L (300 mg/dL) and was unexplained (i.e., no apparent medical, dietary, insulin dosage or pump failure reason)|During 6 weeks of treatment||||events|||Number
2615572|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 96h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 96h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|96h after application of ESAT6-CFP10||||participants|||Number
2615573|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 72h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 72h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|72h after application of ESAT6-CFP10||||participants|||Number
2615574|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 48h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 48h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|48h after application of ESAT6-CFP10||||participants|||Number
2615575|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 24h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 24h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|24h after application of ESAT6-CFP10||||participants|||Number
2615576|NCT01999231|Secondary|the Number of Participants Who Appear the Induration and/or Redness 2h After Application of ESAT6-CFP10|We check the immune response( induration and/or redness) at 2h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.|within 2h after application of ESAT6-CFP10|Induration and/or redness is our main immune response of ESAT6-CFP10.|||participants|||Number
2615577|NCT01999231|Primary|the Cases of Adverse Events With Participant Injection of ESAT6-CFP10|The main examination items :vital signs (breathing, heart rate, blood pressure, body temperature ) of each volunteer at 15min, 30min, 1h, 2h, 4h, 8h, 24h, 48h, 72h, 96h after injection, skin reactivity (redness and/or induration) of injection sites,local reaction ( rash, pain, itching, and skin mucous membranes ) ,a variety of adverse events,routine blood,routine urine, liver and kidney function, ECG and chest X-ray films before and 7 days after intradermal injection .|within 7 days after the injections|ESAT6-CFP10 allergen similar to TB-PPD(Tuberculin purified protein derivative ), main ingredients are protein and can cause specific skin allergy in the injection site ( such as redness, swelling, induration, blisters), besides other local reactions, is still listed as adverse events .|||cases|||Number
2615578|NCT01999218|Secondary|Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 Excluding Rescue Approach|This change from baseline reflects the Week 52 SBP minus the Week 0 SBP. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.|Baseline and Week 52|All randomized, treated participants with at least one SBP measurement (baseline or a post-baseline).|||mmHg||95% Confidence Interval|Least Squares Mean
2615579|NCT01999218|Secondary|Change From Baseline in Body Weight at Week 52 Excluding Rescue Approach|This change from baseline reflects the Week 52 body weight minus the Week 0 body weight. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.|Baseline and Week 52|All randomized, treated participants with at least one body weight measurement (baseline or a post-baseline).|||Kilograms||95% Confidence Interval|Least Squares Mean
2615580|NCT01999218|Secondary|Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 52: Excluding Rescue Approach|Symptomatic hypoglycemia was an event with clinical symptoms reported by the investigator as hypoglycemia (biochemical documentation not required). Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.|Up to Week 52|All randomized participants who took at least one dose of trial treatment.|||Percentage of Participants|||Number
2615581|NCT01999218|Primary|Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 104|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 104|All randomized participants who took at least one dose of trial treatment, 10 randomized participants from one trial site were excluded from these analyzes, and one randomized participant did not receive treatment.|||Percentage of Participants|||Number
2615582|NCT01999218|Primary|Percentage of Participants Experiencing An Adverse Event (AE) Up to Week 106|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 106|All randomized participants who took at least one dose of trial treatment, 10 randomized participants from one trial site were excluded from these analyzes, and one randomized participant did not receive treatment.|||Percentage of Participants|||Number
2615583|NCT01999218|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 52: Excluding Rescue Approach|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication. The primary study objective was the MK-8835 15 mg vs. glimepiride comparison; the MK-8835 5mg vs glimerpiride comparison was a secondary study objective.|Baseline and Week 52|All randomized, treated participants with at least one A1C measurement (baseline or a post-baseline).|||Percent||95% Confidence Interval|Least Squares Mean
2615584|NCT01999192|Other Pre-specified|Evaluation of Safety, Patient Reported Outcomes & Blood Tests.||up to 48 weeks|||||||
2615585|NCT01999192|Other Pre-specified|Pharmacokinetics|AUC, Cmax, Tmax at baseline, and at Week (W) 2/Visit (V) 4, W4/V5, W8/V7, W12/V8, W24/V10, W3/V122, W48 (end of Treatment [EoT]/ early termination ET), and at follow-up (post EoT/post ET).|up to 48 weeks|||||||
2615586|NCT01999192|Secondary|DAS28 Score Individual Components||up to 48 weeks|||||||
2615587|NCT01999192|Secondary|ACR Score Individual Components||up to 48 weeks|||||||
2615588|NCT01999192|Secondary|EULAR Response||up to 48 weeks|||||||
2615597|NCT01999192|Primary|The Proportion of Subjects Who Achieve an ACR20 at Week 12 Following Treatment With Tregalizumab + MTX Compared With Subjects Treated on Placebo + MTX|"The primary efficacy variable was the proportion of subjects with an ACR20 response after 12 weeks of double-blind treatment with the study medication.~The analysis of the primary endpoint was performed using observed cases (OC) on the FAS."|Week 12|"The analysis of the primary endpoint was performed using observed cases (OC) on the FAS.~Full analysis set (FAS): All subjects entered into the study who received at least one dose of study medication and have at least one post-baseline assessment."|||percentage of Subjects|||Number
2615598|NCT01999114|Secondary|ECG Morphology|"Morphological analyses were performed with regard to the digital ECG waveform interpretation as defined by a central ECG laboratory's cardiologist blinded to the study treatment. Changes from baseline to each day of treatment were evaluated separately. Any T-U wave complex that suggested an abnormal form compatible with an effect on cardiac repolarization was noted. New ECG morphological onset changes were presented as the percentage of subjects meeting the new criterion (new meant not present on any baseline ECG and became present on at least 1 on-treatment ECG) for the following variables:~Second degree heart block~Third degree heart block~Complete right bundle branch block (RBBB)~Complete left bundle branch block (LBBB)~ST segment changes (elevation and depression separately)~T-wave abnormalities (negative T waves only)~Myocardial infarction (MI) pattern~Any new abnormal U waves"|Baseline to Day 17|The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.|||Participants|||Count of Participants
2615599|NCT01999114|Secondary|ECG Morphology|"Morphological analyses were performed with regard to the digital ECG waveform interpretation as defined by a central ECG laboratory's cardiologist blinded to the study treatment. Changes from baseline to each day of treatment were evaluated separately. Any T-U wave complex that suggested an abnormal form compatible with an effect on cardiac repolarization was noted. New ECG morphological onset changes were presented as the percentage of subjects meeting the new criterion (new meant not present on any baseline ECG and became present on at least 1 on-treatment ECG) for the following variables:~Second degree heart block~Third degree heart block~Complete right bundle branch block (RBBB)~Complete left bundle branch block (LBBB)~ST segment changes (elevation and depression separately)~T-wave abnormalities (negative T waves only)~Myocardial infarction (MI) pattern~Any new abnormal U waves"|Baseline to Day 13|The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.|||Participants|||Count of Participants
2615600|NCT01999114|Secondary|ECG Morphology|"Morphological analyses were performed with regard to the digital ECG waveform interpretation as defined by a central ECG laboratory's cardiologist blinded to the study treatment. Changes from baseline to each day of treatment were evaluated separately. Any T-U wave complex that suggested an abnormal form compatible with an effect on cardiac repolarization was noted. New ECG morphological onset changes were presented as the percentage of subjects meeting the new criterion (new meant not present on any baseline ECG and became present on at least 1 on-treatment ECG) for the following variables:~Second degree heart block~Third degree heart block~Complete right bundle branch block (RBBB)~Complete left bundle branch block (LBBB)~ST segment changes (elevation and depression separately)~T-wave abnormalities (negative T waves only)~Myocardial infarction (MI) pattern~Any new abnormal U waves"|Baseline to Day 6|The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.|||Participants|||Count of Participants
2615601|NCT01999114|Secondary|Heart Rate (HR)|Mean change from baseline for the BTDS 80 mcg/hr dose on Day 17, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo.|Baseline to Day 17|The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.|||bpm||Standard Deviation|Mean
2615602|NCT01999114|Secondary|QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval|Mean change from baseline for the BTDS 80 mcg/hr dose on Day 17, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo.|Baseline to Day 17|The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.|||msec||Standard Deviation|Mean
2615603|NCT01999114|Secondary|Heart Rate (HR)|Mean change from baseline for the BTDS 40 mcg/hr dose on Day 13, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo.|Baseline to Day 13|The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.|||bpm||Standard Deviation|Mean
2615604|NCT01999114|Secondary|QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval|Mean change from baseline for the BTDS 40 mcg/hr dose on Day 13, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo.|Baseline to Day 13|The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.|||msec||Standard Deviation|Mean
2615605|NCT01999114|Secondary|Heart Rate (HR)|Mean change from baseline for the BTDS 10 mcg/hr dose on Day 6, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo.|Baseline to Day 6|The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.|||bpm||Standard Deviation|Mean
2615606|NCT01999114|Secondary|QTcF and QTcB for Historical Purposes, PR Interval, QRS Interval, and Uncorrected QT Interval|Mean change from baseline for the BTDS 10 mcg/hr dose on Day 6, presented as time-averaged mean change from baseline for BTDS only, BTDS with naltrexone, naltrexone alone, moxifloxacin, and placebo.|Baseline to Day 6|The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.|||msec||Standard Deviation|Mean
2615704|NCT01998399|Secondary|Shock Free Days|Not requiring pressor support for hypotension|15 days|2 participants from the Ticagrelor arm and 1 from the placebo arm died during the 15 day period|||days||Full Range|Mean
2615607|NCT01999114|Primary|The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI)|The effects of 80 mcg/hr buprenorphine (Day 17) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 80 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction.|Baseline to Day 17|"The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.~The placebo treatment group is not presented; however, the placebo data were used as a correction factor for these time-matched analyses."|||msec||90% Confidence Interval|Mean
2615608|NCT01999114|Primary|The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI)|The effects of 40 mcg/hr buprenorphine (Day 13) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 40 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction.|Baseline to Day 13|"The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.~The placebo treatment group is not presented; however, the placebo data were used as a correction factor for these time-matched analyses."|||msec||90% Confidence Interval|Mean
2615609|NCT01999114|Primary|The Maximum Time-matched Change From Baseline in QT Data Corrected for Heart Rate (QTc), Placebo-corrected, Based on an Individual Correction (QTcI) Method (ΔΔQTcI)|The effects of 10 mcg/hr buprenorphine (Day 6) delivered by BTDS alone, or by BTDS dosed with naltrexone, and naltrexone alone on cardiac repolarization, were assessed based on the corrected QT interval since HR inversely affects QT duration. The time-matched analysis was conducted as the primary endpoint as recommended by ICH E14, with the 2-sided 90% confidence interval for each treatment at each time point showing the placebo- and baseline-corrected (ΔΔ) analysis for QTcI. The effect of BTDS 10 on QT intervals was compared with the moxifloxacin-positive control after placebo and baseline correction.|Baseline to Day 6|"The full analysis for ECG population was the group of subjects who were randomized, received at least 1 dose of study drug, and had at least 1 time-matched baseline and 1 on-treatment ECG.~The placebo treatment group is not presented; however, the placebo data were used as a correction factor for these time-matched analyses."|||milliseconds (msec)||90% Confidence Interval|Mean
2615610|NCT01998984|Secondary|Percentage of Participants With Partial Clearance of AKs|"Partial clearance of AKs at Week 8, defined as at least 75% reduction from baseline in number of AKs, was analysed in the same way as the primary response criterion.~The percent reduction at Week 8 from baseline was analyzed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable (using multiple imputations to account for missing values).~The table presents the mean across 1000 multiple imputations. Missing values for AK count were imputed sequentially from a negative binomial regression model with treatment group, AK counts at the previous visit, and analysis site as covariates and log baseline AK count as offset."|At Week 8|The analysis was based on the Full Analysis Set, which was defined as all randomized participants.|||percentage of participants|||Number
2615611|NCT01998984|Secondary|Percentage of Reduction in Actinic Keratosis (AK) Lesion Count From Baseline (Day 1) (Multiple Imputation)|"The number of clinically visible AK lesions identified in the treatment area was to be recorded at Visit 1(≤14 days prior to Day 1).~The analysis was based on 1000 imputations of actinic keratosis lesion count at Week 8 using a negative binomial regression model with factors treatment and analysis site and with log of baseline actinic keratosis lesion count as offset. The table shows the adjusted percentage reduction from baseline.~Values for the Ingenol 4 days arm were calculated separately based on observed cases. On the basis of the data monitoring committee's recommendation the 4-day active treatment group was closed, and this arm was excluded from statistical models and comparisons in the secondary efficacy analyses."|At Week 8|The analysis was based on the Full Analysis Set, which was defined as all randomized participants.|||percentage of reduction||95% Confidence Interval|Mean
2615612|NCT01998984|Primary|Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs)|"Complete clearance of AKs at Week 8 was defined as a 100% reduction from baseline in number of AKs.~The table presents the mean across 1000 multiple imputations. Missing values for AK count were imputed sequentially from a negative binomial regression model with treatment group, AK counts at the previous visit, and analysis site as covariates and log baseline AK count as offset."|At Week 8|The analysis was based on the Full Analysis Set, which was defined as all randomized participants.|||percentage of participants|||Number
2615613|NCT01998958|Secondary|Panel A and B: Change From Baseline (Day 8) in Patient Global Impression of Severity Score Total Score at Day 15 in the Double-Blind Treatment Phase- ANCOVA Analysis on Ranks|PGI-S is a patient-rated scale that assesses the severity of their illness at the time of assessment, relative to participants past experience. It is a 4-point (1 to 4) scale in response to the question 'Considering all aspects of your depression right now would you say your depression is?' with scores as follows: 1: none; 2: mild; 3: moderate; 4: severe. A higher score implies a more severe condition. A negative change in score indicates improvement.|Baseline (Day 8) and Endpoint (Day 15) of Period 2|Period 2 ITT analysis set included non-responders (QIDS-SR16 total score >=11) to placebo treatment in Period 1 and were then randomly re-assigned to a treatment group in Period 2. Only placebo participants with a QIDS-SR16 score >= 11 at End Point Period 1 who were re-randomized in Period 2 are included in the Period 2 summary.|||Unit on a scale||Full Range|Median
2615705|NCT01998399|Primary|All-cause Mortality|death during 90 day study period|90 days||||participants|||Number
2615706|NCT01998360|Secondary|Cosmetic Result|"Regular: scar line straight without any irregularity~Irregular: Some irregularity to scar line~Scalloped: wavy appearane to scar line"|6 weeks||||participants|||Number
2615614|NCT01998958|Secondary|Panel A and B: Change From Baseline (Day 1) in Patient Global Impression of Severity (PGI-S) Score Total Score at Day 8 in the Double-Blind Treatment Phase- ANCOVA Analysis on Ranks|PGI-S is a patient-rated scale that assesses the severity of their illness at the time of assessment, relative to participants past experience. It is a 4-point (1 to 4) scale in response to the question 'Considering all aspects of your depression right now would you say your depression is?' with scores as follows: 1: none; 2: mild; 3: moderate; 4: severe. A higher score implies a more severe condition.|Baseline (Day 1) and Endpoint (Day 8) of Period 1|Period 1 ITT analysis set included all participants randomly assigned to treatment in period 1.|||Unit on a scale||Full Range|Median
2615615|NCT01998958|Secondary|Panel A and B: Change From Baseline (Day 8) in Generalized Anxiety Disorder-7 Total Score at Day 15 (Double-Blind Treatment Phase)- ANCOVA Analysis|GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21).|Baseline (Day 8) and Endpoint (Day 15) of Period 2|Period 2 ITT analysis set included non-responders (QIDS-SR16 total score >=11) to placebo treatment in Period 1 and were then randomly re-assigned to a treatment group in Period 2. Only placebo participants with a QIDS-SR16 score >= 11 at End Point Period 1 who were re-randomized in Period 2 are included in the Period 2 summary.|||Unit on a scale||Standard Error|Least Squares Mean
2615616|NCT01998958|Secondary|Panel A and B: Change From Baseline (Day 1) in Generalized Anxiety Disorder (GAD-7) Total Score at Day 8 (Double-Blind Treatment Phase) ANCOVA Analysis|GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21).|Baseline (Day 1) and Endpoint (Day 8) of Period 1|Period 1 ITT analysis set included all participants randomly assigned to treatment in period 1.|||Unit on a scale||Standard Error|Least Squares Mean
2615617|NCT01998958|Secondary|Panel A and B: Change From Baseline (Day 8) in Clinical Global Impression - Severity Total Score at Day 15 in the Double-Blind Treatment Phase- ANCOVA Analysis on Ranks|CGI-S provides measure of severity of participant's illness including participant's history, psychosocial circumstances, symptoms, behavior and impact of symptoms on ability to function. CGI-S evaluates severity of psychopathology on scale of 0 to 7. Considering total clinical experience, participant is assessed on severity of mental illness according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients. CGI-S permits global evaluation of participant's condition at given time. A negative change in score indicates improvement.|Baseline (Day 8) and Endpoint (Day 15) of Period 2|Period 2 ITT analysis set included non-responders (QIDS-SR16 total score >=11) to placebo treatment in Period 1 and were then randomly re-assigned to a treatment group in Period 2. Only placebo participants with a QIDS-SR16 score >= 11 at End Point Period 1 who were re-randomized in Period 2 are included in the Period 2 summary.|||Units on a scale||Full Range|Median
2615618|NCT01998958|Secondary|Panel A and B: Change From Baseline (Day 1) in Clinical Global Impression - Severity (CGI-S) Total Score at Day 8 in the Double-Blind Treatment Phase- ANCOVA Analysis on Ranks|CGI-S provides measure of severity of participant's illness including participant's history, psychosocial circumstances, symptoms, behavior and impact of symptoms on ability to function. CGI-S evaluates severity of psychopathology on scale of 0 to 7. Considering total clinical experience, participant is assessed on severity of mental illness according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients. CGI-S permits global evaluation of participant's condition at given time. A negative change in score indicates improvement.|Baseline (Day 1) and Endpoint (Day 8) of Period 1|Period 1 ITT analysis set included all participants randomly assigned to treatment in period 1.|||Units on a scale||Full Range|Median
2615619|NCT01998958|Secondary|Panel A and B: Change From Baseline (Day 8) in Quick Inventory of Depressive Symptomatology-16-item Self Report Total Score at Day 15 in the Double-Blind Treatment Phase- ANCOVA Analysis|QIDS-SR16 is self-rated scale assesses severity of depressive symptoms. Total scores range from 0-27. Higher score indicates greater severity of depression. Negative change in score indicates improvement. Total score obtained by adding scores for each of 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders-4th edition major depressive disorder (DSM-IV MDD) criteria: depressed mood, loss of interest/pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, psychomotor changes. 16 items used to rate 9 criterion domains: 4 items used to rate sleep disturbance (early/middle/late insomnia/hypersomnia); 2 items used to rate psychomotor disturbance (agitation, retardation); 4 items used to rate appetite/weight disturbance. 1 item used to rate 6 domains (depressed mood, decreased interest, decreased energy, worthlessness/guilt, concentration/decision making, suicidal ideation). Each item was rated 0-3.|Baseline (Day 8) and Endpoint (Day 15) of Period 2|Period 2 ITT analysis set included non-responders (QIDS-SR16 total score >=11) to placebo treatment in Period 1 and were then randomly re-assigned to a treatment group in Period 2. Only placebo participants with a QIDS-SR16 score >= 11 at End Point Period 1 who were re-randomized in Period 2 are included in the Period 2 summary.|||Unit on a scale||Standard Error|Least Squares Mean
2615655|NCT01998893|Primary|Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR)|Percentage of participants with a CR, PR at the end of the first cycle of treatment (Week 4). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1.500/ microliter (µL), hemoglobin (Hb) >12 grams per deciliter (g/dL), and platelets >100,000/µL. PR was defined as a less than (<) 50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts.|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population|||percentage of participants||95% Confidence Interval|Number
2615620|NCT01998958|Secondary|Panel A and B: Change From Baseline (Day 1) in Quick Inventory of Depressive Symptomatology-16-item Self Report (QIDS-SR16) Total Score at Day 8 in the Double-Blind Treatment Phase- ANCOVA Analysis|QIDS-SR16 is self-rated scale assesses severity of depressive symptoms. Total scores range from 0-27. Higher score indicates greater severity of depression. Negative change in score indicates improvement. Total score obtained by adding scores for each of 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders-4th edition major depressive disorder (DSM-IV MDD) criteria: depressed mood, loss of interest/pleasure, concentration/decision making, self-outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, psychomotor changes. 16 items used to rate 9 criterion domains: 4 items used to rate sleep disturbance (early/middle/late insomnia/hypersomnia); 2 items used to rate psychomotor disturbance (agitation, retardation); 4 items used to rate appetite/weight disturbance. 1 item used to rate 6 domains (depressed mood, decreased interest, decreased energy, worthlessness/guilt, concentration/decision making, suicidal ideation). Each item was rated 0-3.|Baseline (Day 1) and Endpoint (Day 8) of Period 1|Period 1 ITT analysis set included all participants randomly assigned to treatment in period 1.|||Unit on a scale||Standard Error|Least Squares Mean
2615621|NCT01998958|Secondary|Panel A and B: Percentage of Participants in Remission Based on MADRS Total Score at Days 1, 2 and 8 of Double-blind Phase|Participants who had a MADRS total score of less than or equal to (<=10) were considered remitters. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. A negative change in score indicates improvement.|Days 1, 2 and 8 of Double-blind Phase of Period 2|Period 2 ITT analysis set included non-responders (QIDS-SR16 total score >=11) to placebo treatment in Period 1 and were then randomly re-assigned to a treatment group in Period 2. Only placebo participants with a QIDS-SR16 score >= 11 at End Point Period 1 who were re-randomized in Period 2 are included in the Period 2 summary.|||Percentage of participants|||Number
2615622|NCT01998958|Secondary|Panel A and B: Percentage of Participants in Remission Based on MADRS Total Score at Days 1, 2 and 8 of Double-blind Phase|Participants who had a MADRS total score of <=10 were considered remitters. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.|Days 1, 2 and 8 of Double-blind Phase of Period 1|Period 1 ITT analysis set included all participants randomly assigned to treatment in period 1.|||Percentage of participants|||Number
2615623|NCT01998958|Secondary|Panel A and B: Percentage of Participants With Response Based on MADRS Total Score|A participant is defined a responder at a given time point if the percent improvement in MADRS is >=50%. Participant who do not meet such criterion, worsen or discontinue during the DB phase for any reason was considered as non-responders, that is, was assigned a value of 0. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.|Period 2: Days 1 (2 hour), 2 and 8 of Double-blind Phase|Period 2 ITT analysis set included non-responders (QIDS-SR16 total score >=11) to placebo treatment in Period 1 and were then randomly re-assigned to a treatment group in Period 2. Only placebo participants with a QIDS-SR16 score >= 11 at End Point Period 1 who were re-randomized in Period 2 are included in the Period 2 summary.|||Percentage of participants|||Number
2615624|NCT01998958|Secondary|Panel A and B: Percentage of Participants With Response Based on MADRS Total Score|A participant is defined a responder at a given time point if the percent improvement in MADRS is greater than or equal to (>=) 50%. Participant who do not meet such criterion, worsen or discontinue during the DB phase for any reason was considered as non-responders, that is, was assigned a value of 0. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.|Period 1: Days 1 (2 hour), 2 and 8 of Double-blind Phase|Period 1 ITT analysis set included all participants randomly assigned to treatment in period 1.|||Percentage of participants|||Number
2615625|NCT01998958|Secondary|Panel A and B: Percentage of Participants With Sustained Response Based on MADRS Total Score in Participants Who Received the Same Treatment for Both Periods, Including Participants Who Did Not Complete the Double-blind Phase|Sustained response was defined as at least 50 percent (%) improvement from baseline in the MADRS total score with onset by Day 2 that is maintained to study Day 15. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.|Day 2 Up to Day 15|Population analyzed included participants from DB ITT (who were randomly assigned to treatment during the double-blind phase) who received the same treatment for both periods, including participants who did not complete the double-blind Phase.|||Percentage of participants|||Number
2615687|NCT01998477|Primary|Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata|Safety was assessed in terms of number of the subjects (3 to <6 years,(≥ 6 to < 9 years and 9 to <18 Years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV|Day 1 through Day 7 after any vaccination|Analysis was done on safety dataset|||Subjects|||Number
2615626|NCT01998958|Secondary|Panel A and B: Percentage of Participants With Sustained Response Based on MADRS Total Score in Participants Who Have Completed the Double-Blind Phase and Received the Same Treatment for Both Periods|Sustained response was defined as at least 50% improvement from baseline in the MADRS total score with onset by Day 2 that is maintained to study Day 15. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition.|Day 2 Up to Day 15|Population analyzed included participants from double-blind (DB) ITT (who were randomly assigned to treatment during the double-blind phase) who completed the double-blind phase and received the same treatment for both periods.|||Percentage of participants|||Number
2615627|NCT01998958|Primary|Panel A and B: Change From Baseline (Day 8) in Montgomery Asberg Depression Rating Scale Total Score at Day 15- ANCOVA Analysis|MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. A negative change in score indicates improvement.|Baseline (Day 8) and Endpoint (Day 15) of Period 2|Period 2 ITT analysis set included non-responders (QIDS-SR16 total score >=11) to placebo treatment in Period 1 and were then randomly re-assigned to a treatment group in Period 2. Only placebo participants with a QIDS-SR16 score >= 11 at End Point Period 1 who were re-randomized in Period 2 are included in the Period 2 summary.|||Unit on a scale||Standard Error|Least Squares Mean
2615628|NCT01998958|Primary|Panel A and B: Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Day 8- Analysis of Covariance (ANCOVA) Analysis|MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. A negative change in score indicates improvement.|Baseline (Day 1) and Endpoint (Day 8) of Period 1|Period 1 Intent-to-treat (ITT) analysis set included all participants randomly assigned to treatment in period 1.|||Unit on a scale||Standard Error|Least Squares Mean
2615629|NCT01998919|Secondary|Overall Survival|Overall Survival (OS) was defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.|Date of randomization until date of death or date of last follow-up assessment|FAS Population|||weeks||95% Confidence Interval|Median
2615630|NCT01998919|Secondary|Progression-Free Survival (PFS)|PFS was defined as the interval between the day of randomization and the date of first documentation of progressive disease or date of death, whichever came first.|Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases|FAS Population|||weeks||95% Confidence Interval|Median
2615631|NCT01998919|Secondary|Time to Progression|Time to progression was defined as the interval between the day of randomization and the first documentation of PD. Participants who were withdrawn from the study without documented progression and for whom there exists CRF evidence that evaluations have been made, were censored at 1) the date of the last tumor assessment, 2) last date in the drug log, or 3) last date of follow-up when the participant was known to be progression free, whichever was last. Participants without post-baseline tumor assessments but known to be alive were censored at the time of randomization.|Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases|FAS Population|||weeks||95% Confidence Interval|Median
2615632|NCT01998919|Secondary|Duration of Response|Duration of Response was defined similarly for complete responders and partial responders. CR was defined as the date CR was first recorded to the date on which PD was first noted or date of death. PR was defined as the date the first PR was recorded to the date of the first observation of PD or date of death.|Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study Phases|FAS; only participants with CR or PR were included in the analysis.|||weeks||95% Confidence Interval|Median
2615633|NCT01998919|Secondary|Percentage of Participants With Confirmed CR or PR as Assessed by RECIST|CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.|Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases|FAS|||percentage of participants||95% Confidence Interval|Number
2615634|NCT01998919|Secondary|Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST|Non-progression defined as documented best overall tumor response of CR, PR, or SD (where SD was maintained for >16 weeks) per RECIST.|Week 16|FAS|||percentage of participants||95% Confidence Interval|Number
2615635|NCT01998919|Primary|Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)|Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than [>]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started.|Week 8|FAS; for analysis, participants were assigned the treatment group to which they were randomized, regardless of the treatment they actually received.|||percentage of participants||95% Confidence Interval|Number
2615636|NCT01998906|Secondary|Percentage of Participants Surviving at 3 Years||BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|FAS|||percentage of participants||95% Confidence Interval|Number
2615645|NCT01998906|Secondary|Percentage of Participants Achieving Either Complete Response (CR) or Partial Response (PR) According to Modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Assessments were made based on objective tumor measurements of the lesions as recorded in the case report form. In inflammatory cancer, progressive disease (PD) was defined as progression of any of the 2 signs of breast edema and erythema. In non-inflammatory cancer, PD was concluded if either the investigator judged the participant as having progressed at any time prior to surgery, or there was at least a 20% increase in the sum of target lesions (TLs), any new lesion, or clear progression of any nontarget lesion (NTLs). Clear progression of any NTL was defined as at least a 20% increase in the sum of NTLs compared to BL. PR was defined as at least a 30% decrease from BL in the sum of the longest diameter of TLs. CR was defined as no PD as assessed by the investigator and complete disappearance of all lesions.|BL, Presurgery: Day 1 of Cycles 1-10|FAS|||percentage of participants||95% Confidence Interval|Number
2615646|NCT01998906|Secondary|Percentage of Participants With Total Pathological Complete Response (tpCR)|tpCR was defined as a determination of bpCR and an absence of positive axillary nodes on pathology.|BL, Day 1 of Cycles 1-10 (pre-surgery)|FAS|||percentage of participants||95% Confidence Interval|Number
2615647|NCT01998906|Secondary|Percentage of Participants With Breast Pathological Complete Response (bpCR)|bpCR was defined as an absence of any invasive cancer cell of the primary tumor at the time of major surgery after neoadjuvant chemotherapy with and without trastuzumab.|BL, Day 1 of Cycles 1-10 (pre-surgery)|FAS|||percentage of participants||95% Confidence Interval|Number
2615648|NCT01998906|Primary|Event-Free Survival (EFS) - Percentage of Participants With an Event|EFS was defined as the time between randomization and date of documented occurrence of disease recurrence or progression (local, regional, distant or contralateral) or death due to any cause.|Baseline (BL), Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter|The full analysis set (FAS) included all participants who were randomized in the main study or registered in the parallel observational arm.|||percentage of participants|||Number
2615649|NCT01998893|Secondary|Number of Participants With a Clinical Response to Re-Treatment|Clinical response was defined as the best response after the second 4 weeks of treatment cycle by the following categories: CR, PR, MR, SD, and PD. CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL. PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. MR was defined as tumor regression ≥25% and <50%. SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%. PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.|First application in the second treatment cycle until progression of disease. The median length of follow-up was 4.6 months (range: 0.5-20.6 months).|Participants in the ITT population who began a second cycle of treatment.|||participants|||Number
2615650|NCT01998893|Secondary|Overall Survival (OS)|OS was defined as the time, in months, between enrollment into the study and death, due to any cause. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.|Enrollment into study until end of follow-up or death. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population|||months||95% Confidence Interval|Median
2615651|NCT01998893|Secondary|Time to Progression|The median time, in months, from the start of treatment (first application) until detection of PD.|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population|||months||95% Confidence Interval|Median
2615652|NCT01998893|Secondary|Duration of Remission|Median time, in months, between the documentation of CR or PR and PD in clinical responders.|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|Participants in the ITT population with CR or PR after the first treatment cycle.|||months||95% Confidence Interval|Median
2615653|NCT01998893|Secondary|Time to Best Response|The median time, in months, from start of the treatment (first application) until best response (PR or CR).|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population; only participants with at least one application of study treatment within the first 4 weeks of treatment were included in the analysis.|||months||95% Confidence Interval|Median
2615654|NCT01998893|Secondary|Number of Participants With a Clinical Response|Clinical response was defined as the best response after the first 4 weeks of treatment cycle by the following categories: CR, PR, minor response (MR), stable disease (SD), and progressive disease (PD). CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL. PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts. MR was defined as tumor regression ≥25% and <50%. SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%. PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.|Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)|ITT population|||participants|||Number
2615688|NCT01998477|Primary|Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group|Safety was assessed in terms of number of the subjects (3 to < 18 years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV|Day 1 through Day 7 post injection 1 and Day 29 through Day 35 post injection 2|Analysis was done on safety dataset, i.e. the subjects in the Exposed Set who provided post-vaccination solicited AE data|||Subjects|||Number
2615689|NCT01998438|Other Pre-specified|Rate of Reexploration for Bleeding||on the 7th day postoperatively|||||||
2615690|NCT01998438|Secondary|Number of Participants Needs Allogenic Transfusion||on the 7th day postoperatively|||||||
2615656|NCT01998880|Secondary|Percentage of Participants With Best Overall Response|Best overall response according to IWCLL guidelines was defined as the percentage of patients with CR, CRi,PR or nPR. CR required all of the following: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff (median observation 57.7 months)|Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.|||Percentage of participants||95% Confidence Interval|Number
2615657|NCT01998880|Secondary|Duration of Response|Duration of Response was defined as the date the response [either Complete Response (CR) or Partial Response (PR)] was first recorded until the date of Disease Progression or death due to any cause. Response was assessed according IWCLL guidelines.|Randomization to clinical cutoff (median observation 57.7 months)|Participants from the Intent-to-treat population (all randomized participants) with CR or PR. Participants without response were censored.|||Months||95% Confidence Interval|Median
2615658|NCT01998880|Secondary|Time to Re-Treatment/New-antileukemic Therapy|Time to re-treatment/new anti-leukemic therapy was defined as time between the date of randomization and the date of first intake of re-treatment or new anti-leukemic therapy.|Randomization to clinical cutoff (median observation 57.7 months)|Intent-to-treat population included all randomized participants. Participants without events (re-treatment or new anti-leukemic therapy) were censored.|||months||95% Confidence Interval|Median
2615659|NCT01998880|Secondary|European Organization for Research and Treatment of Cancer (EORTC) QLQ-CLL16 Questionnaire Score|EORTC Quality of Life Questionnaire (QLQ-CLL16) module was used to assess patient-reported outcomes and symptom burden. The QLQ-CLL16 module includes three multi-item scales assessing fatigue (2 items), treatment side effects and disease symptoms (8 items), infection (4 items) and two single item scales on social activities and future health worries. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.|Baseline and Cycle 4 Day 1 (Cy4D1)|ITT population. Here, n signifies the number of participants who were evaluated for specified categories.|||unit on a scale||Standard Deviation|Mean
2615660|NCT01998880|Secondary|European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Questionnaire Score|The EORTC Quality of Life Questionnaire QLQ-C30 was used to assess patient-reported outcomes (PRO) and symptom burden. The QLQ-C30 contains 30 items including the functional scales of physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items) and symptom scales including fatigue (3 items), nausea and vomiting (2 items), and pain (4 items) and six single item scales on dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact. Final scores are transformed such that they range from 0 − 100, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 − 10 points considered to be of minimally important difference to participants. A positive change from Baseline indicated improvement.|Baseline and Cycle 4 Day 1 (Cy4D1)|ITT population. Here, n signifies the number of participants who were evaluated for specified categories.|||unit on a scale||Standard Deviation|Mean
2615661|NCT01998880|Secondary|Percentage of Participants With Progression Free Survival Events Based on Independent Review Committee (IRC) Data|Percentage of Participants with Progression Free Survival Events: progression, relapse, or death from any cause as assessed by an Independent Review Committee.|Randomization to clinical cutoff date of 9 May 2013 (median observation 22.7 months)|Intent-to-treat population included all randomized participants. Participants without PFS events were censored.|||Percentage of participants|||Number
2615662|NCT01998880|Secondary|Progression Free Survival Based on Independent Review Committee (IRC) Data|PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by Independent Review Committee. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff date of 9 May 2013 (median observation 22.7 months)|Intent-to-treat population included all randomized participants. Patients without PFS events were censored.|||months||95% Confidence Interval|Median
2615663|NCT01998880|Secondary|Percentage of Participants With Molecular Remission at the End of Treatment|Molecular remission was defined as a minimal residual disease (MRD)-negative result at the end of treatment (assessment that occurred between 56 days and 6 months of last treatment). Molecular remission was assessed for all patients using a blood sample. Additionally, a bone marrow sample was obtained from patients whom the investigator assumed to have a complete response, consistent with the IWCLL guidelines. A combined analysis of blood and bone marrow results was conducted. A patient was considered MRD negative if result was less than 1 CLL cell in 10000 leukocytes (MRD value < 0.0001) based on the method of allele specific polymerase chain reaction (ASO-PCR).|Randomization to clinical cutoff (median observation 57.7 months)|Participants from the Intent-to-treat population (all randomized participants) with MRD data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.|||Percentage of participants||95% Confidence Interval|Number
2615691|NCT01998438|Primary|Postoperative Blood Loss||24hrs postoperatively||||ml||Inter-Quartile Range|Median
2615692|NCT01998399|Other Pre-specified|Discharge Disposition|(Home, other facility, with or without assisted ventilation)|90 days||||Participants|||Count of Participants
2615664|NCT01998880|Secondary|Percentage of Participants With End of Treatment Response (EOTR)|EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. CR required: Peripheral blood lymphocytes below 4 x 10^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils >1.5 x 10^9/L, Platelets >100 x 10^9/L, Hemoglobin >11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils >1.5 x 10^9/ or ≥50% increase, Platelets >100 x 10^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.|Randomization to clinical cutoff (median observation 57.7 months)|Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.|||Percentage of participants||95% Confidence Interval|Number
2615665|NCT01998880|Secondary|Overall Survival|Overall Survival (OS) was defined as the time between the date of randomization and the date of death due to any cause.|Randomization to clinical cutoff (median observation 57.7 months)|Intent-to-treat population included all randomized participants. Patients without OS events were censored.|||Months||95% Confidence Interval|Median
2615666|NCT01998880|Secondary|Event Free Survival|Event-free survival (EFS) was defined as the time between date of randomization and the date of disease progression/relapse, death, or start of a new anti-leukemic therapy. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 57.7 months)|Intent-to-treat population included all randomized participants. Patients without EFS events were censored.|||Months||95% Confidence Interval|Median
2615667|NCT01998880|Primary|Percentage of Participants With Progression Free Survival Events|Percentage of Participants with Progression Free Survival Events: progression, relapse, or death.|Randomization to clinical cutoff (median observation 57.7 months)|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
2615668|NCT01998880|Primary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to the first occurrence of progression, relapse, or death from any cause as assessed by the investigator. Progressive disease required at least one of the following: ≥50% increase in the absolute number of lymphocytes, appearance of new palpable lymph nodes (>15 mm in longest diameter) or any new extra nodal lesion, ≥50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, ≥50% increase in the enlargement of the liver and/or spleen, Transformation to a more aggressive histology or After treatment, the progression of any cytopenia (a decrease of hemoglobin levels >20 g/L or <10 g/dL or a decrease of platelet counts >50% or <100 x 10^9/L or by a decrease of neutrophil counts >50% or <1.0 x 10^9/L).|Randomization to clinical cutoff (median observation 57.7 months)|Intent-to-treat population included all randomized participants. Patients without PFS events were censored.|||Months||95% Confidence Interval|Median
2615669|NCT01998737|Secondary|Number of Participants That Would Require Additional DXA Examination to Confirm Diagnosis|The previously determined thresholds have been applied. The results show amount of subject whose DI value is between the thresholds. These subjects would need DXA measurement to verify diagnosis.|3 years||||Participants|||Count of Participants
2615670|NCT01998737|Primary|Specificity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis|The thresholds for the Density Index (DI) in osteoporosis diagnostics in comparison to dual energy x-ray absorptiometry (DXA) are evaluated in independent population.|3 years||||percentage of true negatives|||Number
2615671|NCT01998737|Primary|Sensitivity of the Density Index Against Dual Energy X-ray Absorptiometry for Detecting Osteoporosis|The thresholds for the Density Index (DI) in osteoporosis diagnostics in comparison to dual energy x-ray absorptiometry (DXA) are evaluated in independent population.|3 years||||percentage of true positives|||Number
2615672|NCT01998633|Secondary|Percentage of Participants With Chronic GVHD|Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification.|1 year post-transplant||||percentage of participants||95% Confidence Interval|Number
2615673|NCT01998633|Secondary|Number of Participants With Chronic GVHD|Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe.|1 year post-transplant||||Participants|||Count of Participants
2615674|NCT01998633|Secondary|Percentage of Participants With Grade II-IV and Grade III-IV Acute GVHD|"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL~2-3 mg/dL~3.01-6 mg/dL~6.01-15.0 mg/dL~>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4"|Day 100 and 6 months post-transplant||||percentage of participants||95% Confidence Interval|Number
2615693|NCT01998399|Other Pre-specified|Hospital Length of Stay|In days|29 days||||days||Full Range|Mean
2615694|NCT01998399|Other Pre-specified|ICU Length of Stay|Includes ICU readmission if during same hospital stay|29 days|2 participants from each arm died during this period|||days||Full Range|Mean
2615695|NCT01998399|Other Pre-specified|Need for Dialysis||28 days||||Participants|||Count of Participants
2615675|NCT01998633|Secondary|Number of Participants With Acute Graft-Versus-Host Disease (GVHD)|"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL~2-3 mg/dL~3.01-6 mg/dL~6.01-15.0 mg/dL~>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4"|1 year post-transplant||||Participants|||Count of Participants
2615676|NCT01998633|Secondary|Percentage of Participants Alive With Sustained Engraftment by Disease Type|Sustained engraftment is defined as the occurrence of whole blood donor chimerism > 5% by Day 42 accompanied by the absence of any primary or secondary graft failure. Primary graft failure is defined as < 5% donor chimerism by Day +42, second stem cell infusion, DLI (except in the case of donor CTLs given for infection control), or second HCT following original HCT. Secondary graft failure is defined as < 5% donor chimerism following initial engraftment.|1 year post-transplant||||percentage of participants||95% Confidence Interval|Number
2615677|NCT01998633|Secondary|Percentage of Participants Alive With Sustained Engraftment|Sustained engraftment is defined as the occurrence of whole blood donor chimerism > 5% by Day 42 accompanied by the absence of any primary or secondary graft failure. Primary graft failure is defined as < 5% donor chimerism by Day +42, second stem cell infusion, DLI (except in the case of donor CTLs given for infection control), or second HCT following original HCT. Secondary graft failure is defined as < 5% donor chimerism following initial engraftment.|1 year post-transplant||||percentage of participants||95% Confidence Interval|Number
2615678|NCT01998633|Secondary|Percentage of Participants With Platelet Engraftment|Platelet engraftment is defined as the first day of a minimum of three measurements on different days that the patient has achieved a platelet count > 20,000 / microliter AND the patient is platelet transfusion independent for a minimum of seven days following conditioning regimen induced nadir.|Day 100 post-transplant||||percentage of participants||95% Confidence Interval|Number
2615679|NCT01998633|Secondary|Percentage of Participants With Neutrophil Engraftment|Time to absolute neutrophil count (ANC) engraftment is defined as the first of three measurements on different days that the patient has an absolute neutrophil count of ≥ 500x10^6/liter following conditioning regimen induced nadir.|Day 42 post-transplant||||percentage of participants||95% Confidence Interval|Number
2615680|NCT01998633|Secondary|Percentage of HLH Participants With HLH Reactivation Post-Transplant|"Systemic HLH Reactivation: Post-transplant HLH reactivation is defined by clinical and lab evidence of pathologic inflammation (persistent fever, progressive cytopenias, rising ferritin and soluble IL2Rα, decreasing fibrinogen, hepatosplenomegaly, end-organ damage) not attributable to other causes.~Central nervous system (CNS) HLH Reactivation: Reactivation of CNS inflammation in patients with HLH may present with or without altered mental status and is defined by pleocytosis in Cerebrospinal fluid (CSF) or an MRI consistent with CNS inflammation not attributable to other causes."|1 year post-transplant|Participants with HLH|||percentage of participants||95% Confidence Interval|Number
2615681|NCT01998633|Secondary|Percentage of Participants With Overall Survival (OS) by Disease Type|Overall survival is defined as survival of death from any cause.|1 year and 18 months post-transplant||||percentage of participants||95% Confidence Interval|Number
2615682|NCT01998633|Primary|Percentage of Participants With Overall Survival (OS)|Overall survival is defined as survival of death from any cause.|1 year and 18 months post-transplant||||percentage of participants||95% Confidence Interval|Number
2615683|NCT01998581|Secondary|Change From Baseline in Subject Satisfaction With Lips on the Lip Module of the FACE-Q Questionnaire|Subjects evaluated satisfaction using the 22 items on the Satisfaction with Lip module of the FACE-Q questionnaire. Scores for each item are combined to create a scale ranging from 0 (worse) to 100 (best). A positive number in change from baseline indicates an improvement, and a negative number in change from baseline indicates a worsening.|Baseline, Month 3|Modified Intent-to-Treat: subjects who were randomized with data at both time points and received at least 1 treatment|||Scores on a Scale||95% Confidence Interval|Mean
2615684|NCT01998581|Secondary|Percentage of Subjects in the JUVEDERM VOLBELLA® XC Treatment Arm With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)|The Evaluating Investigator evaluated the perioral lines severity using the 4-point POLSS where None=No lines; Mild=Few, shallow lines; Moderate=Some, moderate lines; and Severe=Many, deep lines or crevices. The percentage of subjects with at least a 1-point improvement is reported. In accordance with the analysis plan, the analysis with responder rate and 95% Confidence Interval was performed for the JUVEDERM VOLBELLA® XC group only.|Baseline, Month 3|Subjects in the JUVEDERM VOLBELLA® XC group who received treatment in perioral lines with a baseline POLSS score of moderate or severe|||Percentage of Subjects||95% Confidence Interval|Number
2615685|NCT01998581|Primary|Change From Baseline in Evaluating Investigator's Assessment of Lip Fullness on a 5-Point Scale|Lip fullness is assessed by the Evaluating Investigator on the 5-point Lip Fullness Scale 2. Assessments range from 0=minimal flat or nearly flat contour, minimal red lip show (worse) to 4=very marked very significant red lip show, lower lip pout, and upper lip pout (best). A positive number change from baseline indicates improvement and a negative number change from baseline indicates a worsening.|Baseline, Month 3|Modified Intent-to-Treat: subjects who were randomized with a Lip Fullness Scale 2 baseline score of minimal, mild, or moderate and who received at least 1 treatment|||Scores on a Scale||Standard Deviation|Mean
2615686|NCT01998477|Primary|Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata|Safety was assessed in terms of number of subjects who reported any unsolicited AEs (four weeks after 1st vaccination and up to three weeks after 2nd vaccination), serious adverse events (SAEs), new onset of chronic diseases (NOCD), medically attended AEs and AEs leading to vaccine/study withdrawal after receiving one or two doses of either TIVc or TIV by overall age group (3 to <18 years) and age sub-strata (3 to <9 years and 9 to <18 years)|Day 1 -Day 181(one dose group) Day 1 -Day 209(two dose group)|Analysis was done on unsolicited safety dataset, i.e. all subjects in the Exposed Set who have post-vaccination unsolicited AE records (even if no AEs have occurred)|||Subjects|||Number
2615711|NCT01998269|Primary|Measure of Medication Self-Management (MeDS)|The MeDS is an assessment of medication self-management skills. The MeDS tool has 14 questions, the minimum score is 0 (poor medication self-management skills) and the maximum score is 14 (adequate self-management skills). The internal consistency of the scale is .72 (cronbach's alpha), which is considered adequate internal consistency. The MeDS was compared to The Morisky Medication Adherence Scale is one of the most commonly used assessments of medication adherence. It includes 8 questions that assess various factors that can affect medication use, such as forgetfulness, busyness and side effects. Scores range from 0 to 8, with lower scores reflecting better adherence.|cross-sectional, 1 hour interview after clinic visit||||units on a scale||Standard Deviation|Mean
2615712|NCT01998243|Secondary|Percentage of Re-operations|Percentage of Re-operations during all the period of the study ending within 90 days after surgery|during all the period of the study ending within 90 days after surgery||||percentage of participants|||Number
2615713|NCT01998243|Secondary|Rate of Surgical Conversion to Open Surgery|number of patients with surgical conversion from laparoscopic to open surgery|during the initial laparoscopic surgery||||Participants|||Count of Participants
2615714|NCT01998243|Secondary|Hospital Stay,|all in all hospital stay|the period of the study started when patients were randomizated and finished 90 days after surgery||||days||Standard Deviation|Mean
2615715|NCT01998243|Primary|Total Postsurgical Morbidity|"total postsurgical morbidity included the morbidity specifically due to the Intragastric balloon plus all the postoperative morbidity related to the surgical procedure severe intragastric balloon morbidity refers only to medical complications which meet the criteria of severe of The accordion severity grading system ."|during the 6 months having the intragastric balloon and 90 days after surgery|Group B did not receive an intra-gastric balloon, and was thus not evaluated for balloon related complications.|||Participants|||Count of Participants
2615716|NCT01998243|Primary|Postsurgical Morbidity on Both Arms of the Study|postsurgical morbidity includes all kind of post operative morbidity( mild ,moderate and severe) moderate and severe post surgical morbidity is the most important one|within the 90 days after surgery||||Participants|||Count of Participants
2615717|NCT01997905|Secondary|Overall Adverse Event Rate|Overall Adverse Event Rate: Incidence of all device and procedure related adverse events and any neurological related AEs, regardless of attribution, observed through the 3 month and 6 month follow-up assessments, as adjudicated by Independent Physician Adjudicator.|3 month and 6 month post-index procedure|All treated patients.|||participants|||Number
2615718|NCT01997905|Secondary|Overall Serious Adverse Event Rate|Overall Serious Adverse Event Rate: Incidence of all serious adverse events, regardless of attribution, observed through the 3 month and 6 month follow-up assessments, as adjudicated by Independent Physician Adjudicator.|3 month and 6 month Post Index Procedure|All treated patients.|||participants|||Number
2615719|NCT01997905|Secondary|Serious Device or Procedure Related Adverse Event Rate|Overall Serious Device or Procedure Related Adverse Event Rate: Incidence of all serious device or procedure related adverse events observed through the 3 month and 6 month follow-up assessments as adjudicated by Independent Physician Adjudicator.|3 month and 6 month post-index procedure||||participants|||Number
2615720|NCT01997905|Secondary|Rate of Stroke and Non-CNS Systemic Embolism|"The secondary efficacy endpoints will be a composite of the following events within 3 months and 6 months post-index procedure:~Stroke (ischemic )~Non-CNS (Central Nervous System) systemic embolism."|3 months and 6 months post-index procedure||||participants|||Number
2615721|NCT01997905|Primary|Composite Left Atrial Appendage Placement and Exclusion Success|"Primary Efficacy endpoint is a success/failure endpoint with success requiring all of the following:~Patient Technical Success: The ability to successfully implant an AtriClip device at the LAA in a patient.~Intra-Procedural Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (<3 mm residual communication with LAA and <10 mm residual pocket) between the LA and LAA, assessed intra-procedurally by TEE.~3 Month Follow-Up Complete Exclusion of the LAA: The complete exclusion of the LAA defined by lack of fluid communication (<3 mm residual communication with LAA and < 10mm residual pocket) between the LA and LAA at >=3 month TEE or CTA evaluation."|Immediate to 3-months post-index procedure|Ten (10) patients were treated, however the AtriClip® device was not implanted in one (1) patient.|||participants|||Number
2615722|NCT01997905|Primary|Number of Serious Adverse Events Within 30 Days Post-Index Procedure|"The primary safety endpoint consists of the following serious adverse events within 30 days post-index procedure (unless otherwise noted), as adjudicated by Independent Physician Adjudicator:~Serious Injury to the cardiac structure or other body structure deemed to be related to the delivery or placement of the Clip~Cardiac-Related Death, Myocardial Infarction, or Ischemic Stroke~Major bleeding (defined as requiring re-operation and/or transfusion (> 2 U packed red blood cells (PRBC)) within any 24 hour period during the first 2 days post-index procedure or at any time point if attributed to the device/index procedure)."|30 days post-index procedure||||participants|||Number
2615723|NCT01997892|Secondary|Percentage of Participants With Hemoglobin Excursions|The percentage of participants with at least one hemoglobin excursion, defined as hemoglobin concentrations below 10.0 g/dL and above 12.0 g/dL during the pre- and post-switch periods.|Month -3, -2, -1, 1, 2, 3, 4, 5 and 6|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
2615724|NCT01997892|Secondary|Hemoglobin Concentration Rate of Change by Period|The hemoglobin rate of change is the maximum monthly increase and maximum monthly decrease for the pre- and post-switch periods. Within each period, the difference was calculated between each hemoglobin value and the most recent hemoglobin value taken at least 28 days previously. The rate of change was calculated by dividing this difference by the number of days in the interval and multiplying by 28. The maximum and minimum rate of change was then determined per participant.|Thre months prior to switch and 6 months after the switch|Primary Analysis Set with available data|||g/dL/4 week||Standard Deviation|Mean
2615725|NCT01997892|Secondary|Dose Ratio Measured at the Time of Switch From PEG Epoetin Beta to Darbepoetin Alfa|Dose ratio is the average weekly dose of the first darbepoetin alfa dose divided by the average weekly dose of peg-epoetin beta at switch (μg darbepoetin alfa per 1 μg pegylated-epoetin beta).|Week -1 and Week 1|Primary analysis set|||ratio||95% Confidence Interval|Geometric Mean
2615746|NCT01997437|Primary|Safety of Stem-cell Seeded Bioartificial Tracheal Scaffold|Safety of the tissue engineered trachea measured by occurrence of adverse events throughout 12 months post operative follow up|12 months post operative follow up||||participants|||Number
2615726|NCT01997892|Secondary|Darbepoetin Alfa Dose From the Switch Date Until the End of the Observation Period|Mean weekly doses were calculated per participant by first calculating a mean daily dose for the interval (by dividing each dose evenly between the days bounded by its date of administration and the day before the next dose, then taking a mean of these partial doses for the days in the interval) and multiplying by 7 to convert to a weekly dose. Weekly doses >150 μg have been excluded as they were deemed infeasible values derived by the algorithm.|Month 1, 2, 3, 4, 5 and 6|"Primary analysis set; participants with available data at each time point (as indicated by n)."|||μg/week||95% Confidence Interval|Geometric Mean
2615727|NCT01997892|Secondary|PEG Epoetin Beta Dose From the Start of the Observation Period Until the Switch|Mean weekly doses were calculated per participant by first calculating a mean daily dose for the interval (by dividing each dose evenly between the days bounded by its date of administration and the day before the next dose, then taking a mean of these partial doses for the days in the interval) and multiplying by 7 to convert to a weekly dose. Weekly doses >150 μg have been excluded as they were deemed infeasible values derived by the algorithm.|Month -3, Month -2, Month -1|"Primary analysis set; participants with available data at each time point (indicated by n)."|||μg/week||95% Confidence Interval|Geometric Mean
2615728|NCT01997892|Primary|Hemoglobin Concentration at Monthly Intervals|Hemoglobin concentration from 3 months prior to switch to darbepoetin alfa until the end of the observation period.|Month -3, -2, -1 (pre-switch), and Month 1, 2, 3, 4, 5 and 6 (post-switch)|"Primary analysis set; participants with available data at each time point (indicated by n)."|||g/dL||Standard Deviation|Mean
2615729|NCT01997723|Other Pre-specified|Percentage of Participants Who Prefer Home Testing Over Laboratory Testing|Participants indicated which test (PM or PSG) they preferred.|1 week||||percentage of participants|||Number
2615730|NCT01997723|Secondary|Technical Failure Rate|home PM tests that failed to provide technically adequate data for diagnosis. Technical failure(s) were tests where estimated total sleep time (TST) was ≤ 2 hours or portable monitor data of interpretable quality was less than 4 hours per recording.|4 days||||percentage of recordings|||Number
2615731|NCT01997723|Primary|Apnea Hypopnea Index (AHI)|"AHI is the number of abnormal respiratory events (apneas and hypopneas) per hour of sleep.~AHI on home portable monitor (PM) compared to AHI on laboratory polysomnography (PSG)."|4 days|The polysomnography area under the curve (AUC) in an ROC plot for this study was assumed to be 0.99. The AUC for home PM test was targeted at 0.88 based on published report for power of 0.90 in a population with estimated pretest probability of 75-85%, ascertained by Berlin Questionnaire.|||events per hour||Standard Deviation|Mean
2615732|NCT01997567|Secondary|Veterans RAND 12 Item Health Survey (VR-12) Scores|Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.|6 months postoperative|Study was closed due to enrollment issues and data were not collected or analyzed.||||||
2615733|NCT01997567|Secondary|Veterans RAND 12 Item Health Survey (VR-12) Scores|Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.|3 months postoperative|Study was closed due to enrollment issues and data were not collected or analyzed.||||||
2615734|NCT01997567|Secondary|Veterans Research and Development (RAND) 12 Item Health Survey (VR-12) Scores|Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.|Preoperative 2-8 wks|Study was closed due to enrollment issues and data were not collected or analyzed.||||||
2615735|NCT01997567|Primary|Pain Numerical Rating Scale Score (NRS 0-10)|The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.|6 months postoperative|Study was closed due to enrollment issues and data were not collected or analyzed.||||||
2615736|NCT01997567|Primary|Pain Numerical Rating Scale Score (NRS 0-10)|The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.|3 months postoperative|Study was closed due to enrollment issues and data were not collected or analyzed.||||||
2615737|NCT01997567|Primary|Pain Numerical Rating Scale Score (NRS 0-10)|"The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.~Study was closed due to enrollment issues and data were not collected or analized."|3 wks postoperative|Study was closed due to enrollment issues and data were not collected or analized.||||||
2615738|NCT01997567|Primary|Pain Numerical Rating Scale Score (NRS 0-10)|The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.|Preoperative 2-8 wks|Study was closed due to enrollment issues and data were not collected or analyzed.||||||
2615739|NCT01997515|Secondary|Length of Hospital Stay|The subjects length of hospital stay will be recorded. Length of stay is defined as day of surgery to date of discharge from the hospital which may be up to 2 weeks..|Up to 2 weeks||||days||Inter-Quartile Range|Median
2615740|NCT01997515|Secondary|Postoperative Pain Scores|Participants pain scores will be recorded at 24 hours after surgery. Pain scores range from 0 (no pain) to 10 (worst pain imaginable).|24 hours||||score on a scale||Inter-Quartile Range|Median
2615741|NCT01997515|Secondary|Postoperative Opioid Consumption|Total number of opioids (morphine equivalents) consumed 24 hours after surgery|24 hours||||Morphine Equivalents||Inter-Quartile Range|Median
2615742|NCT01997515|Primary|Quality of Recovery 40|Scores on QOR (quality of recovery) 40 questionnaire. The QoR-40 score, which ranges from 40 to 200, representing very poor (low scores) to outstanding quality of recovery (high scores), respectively.|24 hours||||score on a scale||Inter-Quartile Range|Median
2615743|NCT01997437|Primary|Number of Mononuclear Cells (MNCs) Per ml|MNCs were isolated from bone marrow fom each patient, and were counted by flow cytometry method. MNC were used for seeding on scaffold.|1 time before seeding on scaffold||||MNCs per ml||Standard Error|Mean
2615744|NCT01997437|Secondary|Number of Disease Free Survival Patients|The disease free survival of patient were evaluated after transplantation of stem-cell seeded bioartificial trachea during 12 months post operative follow up.|12 months post operative follow up||||participants|||Number
2615747|NCT01997411|Other Pre-specified|Percentage of Participants With >= 25 mg/dL Rise in Plasma Glucose Within 30 Minutes||Pre-dose; 5, 10,15, 20, and 30 minutes following glucagon administration|All enrolled participants that completed the required dosing visit(s). One participant in the 4 to <8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||percentage of participants|||Number
2615748|NCT01997411|Secondary|Time to Achieving ≥25 mg/dL Rise in Plasma Glucose Above Nadir Level Within 30 Minutes|Time (in minutes) when all participants experienced a rise in glucose >=25mg/dL. This is an absolute number and is not a calculated statistic. There is no distribution per cohort.|Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration|All enrolled participants that completed the required dosing visit(s). One participant in the 4 to <8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||minutes|||Number
2615749|NCT01997411|Secondary|Number of Participants Achieving at Least a 25 mg/dL Rise in Blood Glucose Above Nadir Level Within 30 Minutes||Pre-dose; 5, 10, 15, 20, and 30 minutes following glucagon administration|All enrolled participants that completed the required dosing visit(s). One participant in the 4 to <8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||Participants|||Count of Participants
2615750|NCT01997411|Secondary|Nasal and Non-nasal Effects/Symptoms|"Symptoms of runny nose, nasal congestion and/or itching, sneezing, watery and/or itchy eyes, redness of eyes, and itching of ears and/or throat were assessed prior to administering glucagon and at 15, 30, 60 and 90 minutes following administration of glucagon. This was done via the Nasal Non-nasal Score Questionnaire. Each of the 9 symptoms is assigned an integer value from 0 to 3; higher values indicate more severe symptoms (a score of 0 indicates no symptoms). The reported results indicate the cohort median out of a possible maximum value of 27 (summing all 9 questions for each participant and reporting the median/IQR across participants)."|Pre-dose;15, 30, 60 and 90 minutes following glucagon administration|All enrolled participants. One participant in the 8 to <12 group withdrew from the study after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||units on a scale||Inter-Quartile Range|Median
2615751|NCT01997411|Primary|Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline-Adjusted Glucose From Time Zero up to 90 Minutes||Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visit(s). One participant in the 4 to <8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||hr*mg/dL||Standard Deviation|Mean
2615752|NCT01997411|Primary|Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose||Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visit(s). One participant in the 4 to <8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||hours (hr)||Full Range|Median
2615753|NCT01997411|Primary|Maximum Concentration (Cmax) of Baseline-Adjusted Glucose||Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visit(s). One participant in the 4 to <8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||mg/dL||Standard Deviation|Mean
2615754|NCT01997411|Primary|Area Under the Curve (AUC0-1.5) of Baseline Adjusted Glucagon||Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visit(s). One participant in the 4 to <8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||hour*picogram per millilitre (hr*pg/mL)||Standard Deviation|Mean
2615755|NCT01997411|Primary|Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon||Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visit(s). One participant in the 4 to <8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||hours (hr)||Full Range|Median
2615756|NCT01997411|Primary|Maximum Change From Baseline Concentration (Cmax) of Glucagon||Pre-dose; 5, 10, 15, 20, 30, 40, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visit(s). One participant in the 4 to <8 year old 2.0 mg NG group was excluded due to blowing nose after NG administration. One participant in the 8 to <12 group withdrew after completion of the 3.0 mg NG visit and did not complete the 2.0 mg NG visit.|||picograms per millilitre (pg/mL)||Standard Deviation|Mean
2615757|NCT01997398|Secondary|Parkinson's Disease Quality-39 Score (PDQ-39)|"Effects on PDQ-39 scores 6 months following asleep DBS surgery as compared to pre-operative scores. Data from the PDQ-39 can be presented either subset scores or as a single total score. PDQ-39 measures patient quality of life indicators including mobility, activities of daily living, emotional well being, stigma, communication and bodily discomfort. Data from the PDQ-39 can be presented in either subset scores or as a single total score. The full range of the total PDQ-39 scores is from 0 ( no patient related symptoms, or quality of life unaffected) to 156 ( relates having symptoms , or low quality of life).~The subset score ranges are as follows:~mobility: 0 (no patient related symptoms) to 40 (highest patient related symptoms). activities of daily living: 0 to 24; emotional well being: 0-24; stigma: 0-16; cognition: 0-16; communication: 0-12; bodily discomfort: 0-12."|pre-operatively and 6 months post-operatively||||units on a scale||Standard Deviation|Mean
2615771|NCT01996917|Other Pre-specified|Score on the Vancouver Scar Scale (VSS)|A blinded plastic surgeon will evaluate objective scar quality using the Vancouver Scar Scale (VSS). Range of scores is from 0-13 with a higher score indicative of a worse scar.|Up to 1 year|21 subjects were enrolled. Study procedures were performed per breast, therefore, each subject had one breast in the prineo arm and the other breast in the suture arm = a total 42 breasts.|||score on a scale|Breasts|Standard Deviation|Mean
2615758|NCT01997398|Primary|"Off and On Medication Unified Parkinson's Disease Rating III Score (UPDRS)"|"A movement disorders clinician who had completed the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) training performed prospective baseline and 6-month postoperative assessments of motor function using the MDS modified UPDRS III on patients during both off-medication (PD medications held for 12 h) and on-medication states.~UPDRS III motor scores range from 0 (no motor function deficit) to 132 (highest motor function deficit). There were no subscales."|pre-operatively and 6 months post-operatively||||units on a scale||Standard Deviation|Mean
2615759|NCT01997333|Secondary|Pharmacokinetics (PK)|Concentration of the antibody drug conjugate (ADC), total antibody (TA) and free MMAE will be determined.|Following 1 dose of CDX-011.|Samples were obtained from 201 of 213 patients treated with CDX-011. A partial analysis provided below results. Additional analyses were not completed. Results should be interpreted with caution.|||ug/ml||Full Range|Mean
2615760|NCT01997333|Secondary|Adverse Events (AE)|The percentage of patients experiencing one or more adverse events will be summarized by treatment arm, relationship to study drug, and severity.|Usually following at least 1 cycle of study treatment (1 dose of CDX-011 or capecitabine and until discontinuation of follow-up)||||Participants|||Count of Participants
2615761|NCT01997333|Secondary|Overall Survival|Overall Survival (OS) is defined as the number of months from randomization to the date of death due to any cause.|During treatment and 3 months from end of treatment through end of study or approximately up to 5 years.||||months||95% Confidence Interval|Median
2615762|NCT01997333|Secondary|Duration of Response|Duration of response (DOR) is the number of months from the time criteria are first met for either CR or PR, until the first date that PD is objectively documented. The analysis of DOR was determined retrospectively by the central independent review committee,blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and non-target lesions, Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.|Evaluated every 6 - 9 weeks following treatment initiation||||months||95% Confidence Interval|Median
2615763|NCT01997333|Secondary|Objective Response Rate (ORR)|ORR is defined as the percentage of patients who achieve best overall response of complete or partial response. The analysis of ORR was based on ORR events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Complete Response (CR) = Disappearance of all target lesions and non-target lesions, Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions.|Evaluated every 6 - 9 weeks following treatment initiation|Patients with measurable disease.|||percentage of participants||95% Confidence Interval|Median
2615764|NCT01997333|Primary|Progression Free Survival (PFS)|PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or progression in a non-target lesion, or the appearance of new lesions. The primary analysis of PFS was based on PFS events determined retrospectively by the central independent review committee, blinded to treatment assignment and investigator assessments according to RECIST 1.1 criteria.|Evaluated every 6 - 9 weeks following treatment initiation||||months||95% Confidence Interval|Median
2615765|NCT01997229|Primary|Myasthenia Gravis Activities of Daily Living Profile (MG-ADL): Change From Baseline in MG-ADL Total Score at Week 26 by Worst-Rank Analysis of Covariance (ANCOVA)|In the Worst-Rank analysis, the 125 total patients were ranked from best outcome (rank/score of 1) to worst outcome (rank/score of 125).|End of study (Week 26)||||scores on a scale||Standard Error|Least Squares Mean
2615766|NCT01997216|Secondary|Mean Monocular Over-refraction (OR) at Distance|OR is the amount of additional correction needed to improve visual acuity (VA). The OR at dispense was conducted with non-study product to determine lens power for the 9-hour wear. Dispensing of the study product (Pair 1 and Pair 2) was dependent upon lens power as determined by OR and resultant product availability. The OR at 9 hours was conducted with study product. All OR data is reported regardless whether study product was dispensed. Each eye contributed to the mean.|Up to Hour 9|All enrolled participants exposed to study product. OR data is included for the 1 participant not exposed to Delefilcon A MF due to product unavailability.|||diopter||Standard Deviation|Mean
2615767|NCT01997216|Secondary|Mean Binocular HC/HI Visual Acuity at Distance|The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. A negative logMAR value denotes better visual acuity.|Up to Hour 9|All enrolled participants exposed to study product. 1 participant was not exposed to Delefilcon A MF due to product unavailability.|||logMAR||Standard Deviation|Mean
2615768|NCT01997216|Primary|Mean Binocular HC/HI Visual Acuity at Near (40 cm)|The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity.|Up to Hour 9|All enrolled participants exposed to study product. 1 participant was not exposed to Delefilcon A MF due to product unavailability.|||logMAR||Standard Deviation|Mean
2615769|NCT01996982|Secondary|Number of Participant's With Adverse Events From Induction of Therapeutic Hypothermia (TH).|Assess and capture all adverse events from induction of TH with CCS device.|1 year after the enrollment is closed.|No data are available for this study as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, however, no data are available.||||||
2615770|NCT01996982|Primary|Adverse Events From Application and Use of the Core Cooling System (CCS) Device.|"Assess and capture all adverse events (if any) from application and use of the CCS device.~Also assess CCS device interference with participant's standard of care."|1 year after the enrollment is closed|No data are available for this study as the PI has left the institution and no study team member is present. Sincere efforts were made to obtain the data for reporting, however, no data are available.||||||
2615772|NCT01996917|Secondary|Score on Patient Observer Scar Assessment Scale (POSAS)|The subject will complete the subjective part of the Patient Observer Scar Assessment Scale (POSAS) at each post-operative time point. Total score ranges from 6 to 60, with a higher score indicating a worse scar.|Up to 1 year|21 subjects were enrolled. Study procedures were performed per breast, therefore, each subject had one breast in the prineo arm and the other breast in the suture arm = a total 42 breasts.|||score on a scale|Breasts|Standard Deviation|Mean
2615773|NCT01996917|Primary|Operative Time to Closure of Final Skin Layer|This outcome measure looks at the operative time in seconds to closure of the final skin layer using Prineo or standard sutures.|During operation only|21 subjects were enrolled. Study procedures were performed per breast, therefore, each subject had one breast in the prineo arm and the other breast in the suture arm = a total 42 breasts.|||seconds|Breasts|Standard Deviation|Mean
2615774|NCT01996904|Secondary|Ultrasound Diagnosis|US is a diagnostic imaging technique used to visualise deep structures of the body by recording the echoes of pulsed ultrasonic waves directed into the tissues and reflected by tissue planes to the transducer. These echoes are converted into 'pictures' of the tissues under examination. It consists of a non-invasive examination that has practically no adverse effects and allows dynamic visualisation of the tendons during movement of the shoulder.|every three months after the surgery until the 24th month|||||||
2615775|NCT01996904|Primary|ASES Score|The ASES is a 100-point scale which is divided in two sections. Fifty points of which are derived from patient self-report of pain and the other 50 points of which are computed from a formula using the cumulative score of 10 activities of daily living .The item related to pain is evaluated by a VAS (10 cm) that ranges from 0 (no pain at all) to 10 (pain as bad as it can be). The ten activities of daily living include skills such as putting on a coat, sleeping on the affected side, wash back/do up bra in back, manage toileting, combing one's hair, reach a high shelf, lift 10lbs above shoulder,throw a ball overhand,do usual work and do usual sport.The items related to function are evaluated by a four-point Likert scale. The scores of the pain and function subsections are transformed in percentages and each one represents 50% of the final score, which can range from 0 (absence of function) to 100 (normal function).|24th month||||units on a scale||Standard Deviation|Mean
2615776|NCT01996852|Other Pre-specified|TGF-B1 Levels|Total level of Transforming Growth Factor Beta-1 levels will be assessed using a commercially available assay|baseline - 1 week after start of treatment|||||||
2615777|NCT01996852|Other Pre-specified|Change in Volume of Flaccid Penile Blood Flow|Change from baseline in the total penile blood flow will be assessed by a color and spectral Doppler ultra sound of the cavernosal arteries|10 months after start of treatment|||||||
2615778|NCT01996852|Other Pre-specified|Change in Volume of Flaccid Penile Blood Flow|Change from baseline in the total penile blood flow will be assessed by a color and spectral Doppler ultra sound of the cavernosal arteries|7 months after start of treatment|||||||
2615779|NCT01996852|Other Pre-specified|Change in Stretched Penile Length|Change from baseline in the total length of patients stretched penis. Length will be measured using Mounding's method|10 months|||||||
2615780|NCT01996852|Other Pre-specified|Change in Stretched Penile Length|Change from baseline in the total length of patients stretched penis. Length will be measured using Mounding's method|7 months|||||||
2615781|NCT01996852|Other Pre-specified|Change in Flaccid Penile Length|Change from baseline in the total length of patients flaccid penis. Length will be measured using Mounding's method|10 months|||||||
2615782|NCT01996852|Other Pre-specified|Change in Flaccid Penile Length|Change from baseline in the total length of patients flaccid penis. Length will be measured using Mounding's method|7 months|||||||
2615783|NCT01996852|Other Pre-specified|Change in Perceived Partner Support|change from baseline in a total score from a sub-scale of the Social Support for Exercise Behavior Questionnaire as modified by the study team to measure partner support for rehabilitation. Higher scores will indicate greater support.|10 months after start of treatment|||||||
2615784|NCT01996852|Other Pre-specified|Change in Perceived Partner Support|change from baseline in a total score from a sub-scale of the Social Support for Exercise Behavior Questionnaire as modified by the study team to measure partner support for rehabilitation. Higher scores will indicate greater support.|7 months after start of treatment|||||||
2615785|NCT01996852|Other Pre-specified|Change in Level of Sensual Pleasure of Sex|Change from baseline in a sub-score of the Sexual Function Questionnaire where higher scores indicate greater pleasure.|10 months after start of treatment|||||||
2615786|NCT01996852|Other Pre-specified|Change in Level of Sensual Pleasure of Sex|Change from baseline in a sub-score of the Sexual Function Questionnaire where higher scores indicate greater pleasure.|7 months after start of treatment|||||||
2615787|NCT01996852|Other Pre-specified|Self-Efficacy Improvement|Change from baseline in the mean score of Bandura's measure to assess self-efficacy. This scale is scored from 0-100, where 100 indicates complete confidence.|10 months after start of treatment|||||||
2615788|NCT01996852|Other Pre-specified|Self-Efficacy Improvement|Change from baseline in the mean score of Bandura's measure to assess self-efficacy. This scale is scored from 0-100, where 100 indicates complete confidence.|7 months after start of treatment|||||||
2615789|NCT01996852|Secondary|Change in Overall Quality of Life (QoL) Score|Change in the total score from baseline on the Short-Form-36 Health Survey (SF36) will be used to show changes in QoL. Higher scores indicate increased QoL. QOL in eight dimensions, including physical, role and social functioning, role limitations, and general physical and mental health.|7 months after start of treatment|The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2615790|NCT01996852|Secondary|Sexual Quality of Life (QoL) Improvement|Change from baseline in the total score of the Sexual Quality of Life (male/female) scales|7 months after start of treatment|The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2615791|NCT01996852|Secondary|Change in Treatment Compliance|Change from baseline in the number of patients compliant with treatment. Patients will be described as regular user, intermittent user, or drop out based on the information recorded in the patients Sex Diary over the previous seven days.|7 months after start of treatment|The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2615792|NCT01996852|Secondary|Change in Frequency of Sexual Activity|Change from baseline in the mean value of sexual activities ((1) Sexual encounters; (2) Sexual simulation; (3) intercourse; and (ejaculation)) experienced by each participant over the previous seven days|10 months after start of treatment|The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2615793|NCT01996852|Secondary|Change in Frequency of Sexual Activity|Change from baseline in the mean value of sexual activities ((1) Sexual encounters; (2) Sexual simulation; (3) intercourse; and (ejaculation)) experienced by each participant over the previous seven days|7 months after start of treatment|The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2615794|NCT01996852|Secondary|Change in Treatment Compliance|Change from baseline in the number of patients compliant with treatment. Patients will be described as regular user, intermittent user, or drop out based on the information recorded in the patients Sex Diary over the previous seven days.|10 months after start of treatment|The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2615795|NCT01996852|Secondary|Improved Mood Score|Change from baseline in the sub-score from the 21-item Profile of Mood States (POMS) will be used to measure psychological adjustment to cancer. It will be used to measure depression, anxiety and anger. Higher scores indicate more mood disorder.|10 months after start of treatment|The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2615796|NCT01996852|Secondary|Change in Overall Quality of Life (QoL) Score|Change in the total score from baseline on the Short-Form-36 Health Survey (SF36) will be used to show changes in QoL. Higher scores indicate increased QoL. QOL in eight dimensions, including physical, role and social functioning, role limitations, and general physical and mental health.|10 months after start of treatment|The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2615797|NCT01996852|Secondary|Sexual Quality of Life (QoL) Improvement|Change from baseline in the total score of the Sexual Quality of Life (male/female) scales. Higher scores indicate better quality of life.|10 months after start of treatment|The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2615798|NCT01996852|Primary|Change in Number of Erections|Change from baseline in the number of patients with a score of >=22 on the International Index of Erectile Function (IIEF). This score signifies the presence of erection.|7 months after start of treatment|The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2615799|NCT01996852|Primary|Erectile Function Improvement|Change in Total score in the International Index of Erectile Function (IIEF) between baseline and 7 months. The IIEF assesses male sexual function in five domains: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Higher scores indicate improved functioning.|7 months after start of treatment|The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2615800|NCT01996852|Primary|Change in Number of Erections|Change from baseline in the number of patients with a score of >=22 on the International Index of Erectile Function (IIEF). This score signifies the presence of erection.|10 months after start of treatment|The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2615801|NCT01996852|Primary|Erectile Function Improvement|Change in Total score in the International Index of Erectile Function (IIEF) between baseline and 10 months. The IIEF assesses male sexual function in five domains: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Higher scores indicate improved functioning.|10 months after start of treatment|The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.||||||
2615802|NCT01996813|Secondary|Operation Time|The length of operation time (in minutes) is compared between prospective patients who underwent shoulder arthroscopy in the beach chair position while wearing thigh-high compression stockings versus historical control patients who underwent shoulder arthroscopy in the beach chair position and did not wear thigh-high compression stockings.|End of surgery|The analysis population comprises the 23 prospective cases who met inclusion criteria and were not excluded by the principal investigator as well as 24 historical control participants.|||Minutes||Standard Deviation|Median
2615803|NCT01996813|Primary|Cerebral Desaturation Event|The prevalence of a cerebral desaturation event is compared between prospective patients who underwent shoulder arthroscopy in the beach chair position while wearing thigh-high compression stockings versus historical control patients who underwent shoulder arthroscopy in the beach chair position and did not wear thigh-high compression stockings.|Assessed intraoperatively, an average of 114 minutes|The analysis population comprises the 23 prospective cases who met inclusion criteria and were not excluded by the principal investigator as well as 24 historical control participants.|||Participants|||Count of Participants
2615804|NCT01996748|Secondary|Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Follow-up (Day 15) Compared to Baseline (Day 1).|"Analysis of the change on global scores of otoscopic signs at the end of treatment (mean global scores of otoscopic signs on day 15 compared to baseline).~Erythema, edema and scaling were assessed on a 4 point ordinal scale; 0=absent, 1=mild, 2=moderate, 3=severe."|Baseline and day 15||||units on a scale||Standard Deviation|Mean
2615805|NCT01996748|Secondary|Change in Mean Global Scores of Otoscopic Signs (Erythema, Edema and Scaling) at the End of Treatment (Day 8) Compared to Baseline (Day 1).|"Analysis of the change on global scores of otoscopic signs at the end of treatment (mean global scores of otoscopic signs on day 8 compared to baseline).~Erythema, edema and scaling were assessed on a 4 point ordinal scale; 0=absent, 1=mild, 2=moderate, 3=severe."|Baseline and day 8||||units on a scale||Standard Deviation|Mean
2615806|NCT01996748|Secondary|Change in Signs/ Symptoms|- Change in itching at follow-up (mean itching on days 9-15 compared to baseline).|Baseline and days 9-15||||units on a scale||Standard Deviation|Mean
2616057|NCT01994486|Secondary|Proportion of Subjects With Viral Relapse|Defined as Subjects who have undetectable HCV RNA at end of treatment, and confirmed detectable HCV RNA between end of treatment and SVR12 planned assessment time point.|1/3/2014-9/8/2014||||participants|||Number
2615807|NCT01996748|Primary|Analysis of the Itching Change at the End of Treatment.|The analysis of the itching change at the end of treatment (mean itching on days 4-8 compared to baseline). Itching was assessed on a 4 point ordinal scale; 0=absent, 1=mild, 2=moderate, 3=severe|Baseline and days 4-8||||units on a scale||Standard Deviation|Mean
2615808|NCT01996709|Secondary|Mean Frequency Score for Symptoms of Dryness at Day 90|"As reported and interpreted by the subject on a questionnaire. The subject was asked During a typical day in the past 2 weeks, how often did your eyes feel dry? and responded on a 5-point scale ((0 = Never; 1 = Rarely; 2 = Sometimes; 3 = Frequently; 4 = Constantly)."|Day 90|"This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed. Here, n is subjects with non-missing values at the specific time point for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
2615809|NCT01996709|Secondary|Mean Frequency Score for Symptoms of Grittiness at Day 90|"As interpreted and reported by the subject on a questionnaire. The subject was asked, During a typical day in the past 2 weeks, how often did your eyes feel gritty and/or scratchy while wearing your contact lenses? and responded on a 5-point scale (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Frequently; 5 = Constantly)."|Day 90|This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.|||units on a scale||Standard Deviation|Mean
2615810|NCT01996709|Secondary|"Top 2 Box Percentage Agreement for My Lenses Feel Like New at Day 90"|As interpreted and reported by the subject on a questionnaire. A 5-point Likert scale was used, where 1=strongly disagree; 2=disagree; 3=undecided; 4=agree; 5=strongly agree. The Top-2-box response (agree, strongly agree) was calculated and reported as a percentage of all responses.|Day 90|This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.|||percentage of subjects|||Number
2615811|NCT01996709|Primary|Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90|Lid papillae (bumps on the inner eyelid) were assessed by the investigator using slit-lamp biomicroscopy and classified independently for the four palpebral zones (upper lid=1-3; lower lid=4) on a 5-point forced choice scale, where 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum of the four zones was selected for the analysis. Both eyes were included in the model for analysis. A higher change value indicates a larger reduction in the severity of the lid papillae.|Baseline (Day 0), Day 90|"This analysis group includes all subjects exposed to a study regimen with post baseline efficacy assessments. No imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed. Here, n is subjects with non-missing values at the specific time point for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
2615812|NCT01996657|Secondary|All Cause Deaths|The deaths from all causes|Up to 24 months||||Participants|||Count of Participants
2615813|NCT01996657|Primary|Thrombotic Events|The thrombotic events included valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction.|24 months||||Participants|||Count of Participants
2615814|NCT01996657|Primary|Bleeding Events;|The bleeding events included cerebral hemorrhage, gastrointestinal bleeding and other major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. vision loss) or necessitates transfusion.|Up to 24 months||||Participants|||Count of Participants
2615815|NCT01996644|Other Pre-specified|Fear of Food Measure|"The Fear of Food Measure (FOFM) was designed to assess three cognitive behavioral components related to mealtime anxiety. All items are rated on a 1 to 7 Likert-type scale ranging from not at all to very much so. Higher values indicate worse outcomes. The first subscale is the anxiety about eating subscale, which was designed to assess trait levels of fear and anxiety surrounding eating and food. This subscale will be measured once before and after the trial (twice in 2 weeks). Each item (8 items totaled, each scored 1-7; max possible score is 56; min possible score is 8) was added for each time point and time points were averaged together for all participants for both time points."|Twice during 2 weeks|All combined represents the total number of participants (n=40); however 4 participants withdrew. Analysis utilized data for 36 participants who started in participant flow, thus (n=36).|||Units on a scale||Standard Deviation|Mean
2615816|NCT01996644|Primary|Body Mass Index|BMI will be measured twice a week for two weeks and once before starting the trial. BMI is combined in a repeated measures ANOVA to give total BMI difference across condition.Difference in BMI from Time 1 to Time 4 was outcome.|twice a week for two weeks and at initial assessment||||kg/m^2||Standard Deviation|Mean
2615817|NCT01996644|Primary|Anxiety as Measured by the Subjective Units of Distress (Ranging From 1 to 100).|"Anxiety will be measured at 4 sessions, twice a week for two weeks. Anxiety is combined in a repeated measures ANOVA to give total anxiety decreased across condition.~Anxiety was measured using the Subjective Units of Distress (ranging from 1 to 100), where 1 is no anxiety and 100 is the most anxiety ever experienced."|Twice a week for two weeks||||Units on a scale||Standard Deviation|Mean
2615818|NCT01996592|Primary|Persistent Pain-EMOTIONAL DISTRESS|"By identifying preoperative risk factors for chronic pain and mapping out the trajectory of pain after cesarean delivery, we may be able to use novel pharmacologic or psychological interventions to alter postoperative pain trajectories. Two predominant risk factors have been determined thus far to put those at risk. They are emotional distress/depression and perceived stress. The 530 participants recovery pain scores were broken down into 3 subgroups--group 1 is those who had the fastest recovery, group 2 which is the average recovery, and group 3 which is the group with the slowest recovery.~PROMIS Emotional Distress-Depression Short form utilized for this outcome. scoring for this ranges from 8-40, with the higher the score the worse the distress"|60 days||||units on a scale||Standard Deviation|Mean
2615859|NCT01995838|Secondary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs||Baseline up to Day 30|The safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||participants|||Number
2616274|NCT01991977|Secondary|Overall Survival|The distributions of survival times and comparisons between study patients and historical controls will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause, assessed up to 5 years||2023-12-31|12/2023||||
2615819|NCT01996592|Primary|Persistent Pain-PERCEIVED STRESS Scores Stratified by the Rate of Recovery|"By identifying preoperative risk factors for chronic pain and mapping out the trajectory of pain after cesarean delivery, we may be able to use novel pharmacologic or psychological interventions to alter postoperative pain trajectories. Two predominant risk factors have been determined thus far to put those at risk. They are emotional distress/depression and perceived stress. The 530 participants recovery pain scores were broken down into 3 subgroups--group 1 is those who had the fastest recovery, group 2 which is the average recovery, and group 3 which is the group with the slowest recovery."|60 days||||units on a scale||Standard Deviation|Mean
2615820|NCT01996410|Primary|MDASI Score of Chemotherapy-associated Symptoms With Acupuncture Treatment|"The investigators will first plot M.D. Anderson Symptom Inventory Core Items (MDASI) scores over time for the acupuncture and control groups to visually inspect for differences between the two groups. The investigators will further evaluate the difference in MDASI scores for the two groups using linear mixed models that account for multiple measurements within a single patient. A mixed model is preferable to a repeated measures ANOVA in this case, as it allows for missing time points within a single subject without eliminating that subject from the analysis.~Additionally, the investigators are able to specify how our time points are correlated within patients rather than assuming equal correlation across time points. The MDASI is comprised of 13 separate items that are not summative; therefore, the significance level for all statistical tests will be set at 0.003 (0.05/13) to account for multiple comparisons."|15 months|Per IRB guidelines, we were not permitted to analyze the 10 patients enrolled since we did not meet completed enrollment numbers.||||||
2615821|NCT01996332|Secondary|Overall Survival (OS) by Line of Treatment|Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date or last known alive date [if death date was unavailable] minus the date of first dose of study medication plus 1 divided by 30.44).|Baseline, every 6-8 weeks up to 3 years, or until death|ITT Population; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line|||months||95% Confidence Interval|Median
2615822|NCT01996332|Secondary|Percentage of Participants Achieving Clinical Benefit by Line of Treatment|Efficacy was analyzed in terms of clinical benefit, defined as the sum of the number of participants achieving complete response [CR], partial response [PR], or stable disease [SD]. Tumor response was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. CR was defined as disappearance of all target and non-target lesions. PR was defined as greater than or equal to (≥)30 percent (%) decrease in sum of longest diameters of target lesions taking as reference baseline sum longest diameters associated to non-progressive disease response for non target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions.|Baseline, every 6-8 weeks up to 3 years or until death|Response evaluable population: participants with measurable disease and with matching criteria to have a response assessment; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line|||percentage of participants||95% Confidence Interval|Number
2615823|NCT01996332|Primary|Time to Disease Progression or Death by Line of Treatment|Time to progression or death was defined as the time from inclusion to the date of disease progression or death, whichever occurred first.|Baseline, every 6-8 weeks up to 3 years until disease progression or death|ITT Population; data were analyzed in 6 cohorts, with erlotinib treatment as: 1) first line; 2) maintenance after first line; 3) second line; 4) maintenance after second line; 5) third or subsequent line; or 6) maintenance after third line|||months||95% Confidence Interval|Median
2615824|NCT01996319|Secondary|Trough FEV1 Comparison Between QVA149 and Placebo After 22 Days|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the FEV1 measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period|||Liters||Standard Deviation|Mean
2615825|NCT01996319|Secondary|Peak Forced Expiratory Volume 1 (FEV1) Comparison Between QVA149 and Placebo at Day 1|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. The FEV1 measurements collected prior to dosing on either Day 1 or 36, respectively, were subtracted from the appropriate peak measures on the same respective days|Day 1 or day 36|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period|||Liters||Standard Deviation|Mean
2615826|NCT01996319|Secondary|Change From Baseline in the Trough IC Comparison Between QVA149 and Placebo|Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 20 post treatment initiation were included in this analysis.|||Liters||Standard Deviation|Mean
2615860|NCT01995838|Secondary|Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Parameters||Baseline up to Day 30|The safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.|||participants|||Number
2617047|NCT01984424|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 22 and 24||Baseline and weeks 22 and 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
2615827|NCT01996319|Secondary|Change From Baseline in Peak IC Comparison Between QVA149 and Placebo on Day 1.|Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. The IC measurements collected prior to dosing on either Day 1 or 36, respectively, were subtracted from the appropriate peak measures on the same respective days|Day 1 or day 36|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 1 post treatment initiation were included in this analysis.|||Liters||Standard Deviation|Mean
2615828|NCT01996319|Secondary|Change in the Duration of at Least Moderate Activity Per Day Comparison of QVA149 Versus Placebo|Least moderate activity (defined as 3,5-7kcal/min) will be measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22, plus baseline day 36 and day 57 data were included in this analysis.|||Minutes||Standard Deviation|Mean
2615829|NCT01996319|Secondary|Change in the Comparison of QVA149 vs. Placebo on the Average Number of Steps Per Day|The average number of steps per day will be measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day 1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22 data, plus baseline on day 36 and day 57 data were included in this analysis|||Steps/day||Standard Deviation|Mean
2615830|NCT01996319|Primary|Change From Baseline in the Comparison of QVA149 Versus Placebo With Respect to Average Physical Activity Level|Average physical activity level is defined by average daily activity-related energy consumption [Kcal/day], measured via Actinography device. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the activity measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. Only patients with baseline and day 22 data, plus baseline on day 36 and day 57 data were included in this analysis.|||kcal/day||95% Confidence Interval|Least Squares Mean
2615831|NCT01996319|Primary|Change From Baseline in Peak Inspiratory Capacity (IC) Comparison Between QVA149 and Placebo|Inspiratory capacity (IC) will be measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements will be calculated and reported in liters. In this cross-over trial, we had two baselines collected at day 1 and collected at day 36. From the IC measurements collected on either Day 22 or 57, respectively, the appropriate baseline measurements were subtracted - so either Day 22-Day1 or Day 57-Day36|Baseline, day 22, baseline day 36, day 57|Full Analysis Set (FAS): all randomized patients who applied at least one dose of study medication during at least one study period. all patients were included in these analyses when baseline and day 22 data plus baseline day 36 and day 57 data were available.|||Liters||95% Confidence Interval|Least Squares Mean
2615832|NCT01996254|Secondary|Subject Satisfaction Survey|Subjects completed a sponsor-developed survey with questions pertaining to their feelings about therapy as delivered by the SPRINT Beta Stimulation System as a method for managing chronic post-amputation pain. Subjects were asked to report on their experience using the therapy. Depending on the question, subjects were asked to indicate their agreement with the question (strongly disagree, agree, neutral, disagree, strongly disagree), their comfort with the therapy (very uncomfortable, a little bit uncomfortable, fairly comfortable, very comfortable), or when pain relief was felt (immediately, a few minutes later, a few hours later, more than a day later or never). Responses are presented for key groups of questions related to the therapy whereby answer options are considered affirmative for strongly agree/agree, very easy/easy, very comfortable/comfortable.|Visit 11 (8-weeks post-Start of Treatment (SOT))|Of the 28 total subjects, 14 subjects that used one version of the stimulator (Sprint Beta) were asked to complete subject surveys and 6 of the 14 responded. Results are presented for the 6 surveys.|||Participants|||Count of Participants
2615833|NCT01996254|Secondary|Percent Change in Hours of Daily Prosthetic Usage|Subjects completed daily diaries in which they tracked the number of hours of their prosthetic usage. The 7-day mean prosthetic use was calculated for each subject from their baseline diary and compared to the 7-day mean from week 4 and week 8. The percent change from baseline was then calculated for each subject at each time point (i.e., 4-week median vs. baseline median and 8-week median vs. baseline median). A positive value indicates an increase in prosthetic usage.|Baseline, 4-weeks Post-Start of Treatment (SOT), and 8-weeks Post-SOT|Full Analysis Set: Subjects from the Revised Study Design that enrolled and met all eligibility prior to Lead placement.|||percent change||Full Range|Median
2615834|NCT01996254|Secondary|Change in Opioid Analgesic Usage From Baseline|Changes in opioid analgesic usage were calculated using morphine equivalent dosing (MED) for subjects who were using opioid analgesics at baseline. Subjects completed daily diaries in which they tracked their use of analgesic medications. For Group 1 subjects, the mean daily MED from the baseline diary was compared to the mean daily MED during week 4 and week 8. For Group 2 subjects, the daily MED from the baseline diary was compared to the daily MED during week 4 only. The median percent change from baseline is reported. Certain time points for Group 2 (i.e., after crossover) were considered exploratory but are being reported within this outcome measure for ease of data entry and readability.|Baseline, 4-weeks Post-Start of Treatment (SOT), and 8-weeks Post-SOT|Full Analysis Set: Subjects from the Revised Study Design that enrolled and met all eligibility prior to Lead placement. Only the 9 subjects that were using opioid analgesics at baseline were included in the analysis.|||percent change||Full Range|Median
2616058|NCT01994486|Primary|Safety of Telaprevir and Sofosbuvir When Dosed in Combination for 12 Weeks|The number of subjects who experienced Grade 3 anemia. Complete blood count was collected at baseline, week 2, week 4, week 8, week 12, week 18, and week 24. Incidence of moderate anemia (Grade 3) observed in the study treatment period.|1/3/2014-4/10/2014||||participants|||Number
2615835|NCT01996254|Secondary|Depression at Monthly Intervals After Start of Therapy|The Beck Depression Inventory (BDI-II) is a validated, 21-question survey used to measure depression severity. Question are rated on a scale from 0 to 3, and the scores from each question are totaled to provide an overall score ranging between 0 to 63. Scores from 0-13 indicate minimal depression, 14-19 mild depression, 20-28 moderate depression, and 29-63 severe depression. Group 1 subjects: baseline BDI-II score was compared to BDI-II scores at monthly intervals. Group 2 subjects: baseline BDI-II score was compared to their BDI-II score at the end of 4 weeks. The percent change from baseline to each monthly interval is reported. Certain timepoints for Group 2 (i.e., after crossover) were considered exploratory but are being reported within this outcome measure for ease of data entry and readability.|Baseline, 4-weeks Post-Start of Treatment (SOT), 8-weeks Post-SOT, 3-months Post-SOT, 4-months Post-SOT, 5-months Post-SOT, 6-months Post-SOT, 7-months Post-SOT, 8-months Post-SOT, 9-months Post-SOT, 10-months Post-SOT, 11-mo Post-SOT, & 12-mo Post-SOT|Full Analysis Set: Subjects from the Revised Study Design that enrolled and met all eligibility prior to Lead placement.|||percent change||Full Range|Median
2615836|NCT01996254|Secondary|Proportion of Group 1 (Treatment) Subjects That Experienced ≥ 10-point Reduction in Pain Disability at Monthly Intervals Post-Start of Treatment Compared to Group 2 (Control) Subjects at Week 4 Post-Start of Treatment|The Pain Disability Index (PDI) is a validated survey measuring the degree pain disrupts 7 categories of life activities on a scale from 0 to 10, with higher scores indicating greater disability. The 7 scores were summed for each subject to provide an overall pain disability score. For Group 1 subjects, the baseline average PDI score was compared to PDI scores at monthly intervals. For Group 2 subjects, the baseline average PDI score was compared to their PDI score at the end of 4 weeks. The proportion of successes (subjects reporting ≥10 point reduction in PDI scores from baseline) are reported for Group 1 subjects. Certain time points for Group 2 (i.e., after crossover) were considered exploratory but are being reported within this outcome measure for ease of data entry and readability.|Baseline, 4-weeks Post-Start of Treatment (SOT), 8-weeks Post-SOT, 3-months Post-SOT, 4-months Post-SOT, 5-months Post-SOT, 6-months Post-SOT, 7-months Post-SOT, 8-months Post-SOT, 9-months Post-SOT, 10-months Post-SOT, 11-mo Post-SOT, & 12-mo Post-SOT|Full Analysis Set: Subjects from the Revised Study Design that enrolled and met all eligibility prior to Lead placement.|||Participants|||Count of Participants
2615837|NCT01996254|Secondary|Proportion of Subjects That Experienced ≥50% Reduction in Average Pain Interference With Daily Activities|Degree of post-amputation pain that interfered with 7 aspects of daily life was rated [scale (0 to 10) with higher scores indicating greater interference]. The 7 individual scores were averaged to provide an overall pain interference score. Pain interference questions (Brief Pain Inventory - Short Form Question 9) were used for each qualifying area of pain (phantom and/or residual limb pain). Group 1 subjects: baseline average pain interference scores were compared to average pain interference scores for the same region(s) of pain at each monthly interval after the start of therapy. Group 2 subjects: baseline average pain interference scores were compared to their average score at the end of 4 weeks. Proportion of successes (subjects that experienced ≥50% reduction in average pain interference scores) is reported. Certain time points for Group 2 (i.e., after crossover) were considered exploratory but are being reported here for ease of data entry and readability.|Baseline, 4-weeks Post-Start of Treatment (SOT), 8-weeks Post-SOT, 3-months Post-SOT, 4-months Post-SOT, 5-months Post-SOT, 6-months Post-SOT, 7-months Post-SOT, 8-months Post-SOT, 9-months Post-SOT, 10-months Post-SOT, 11-mo Post-SOT, & 12-mo Post-SOT|Long Term Analysis Set: Subjects from the Revised Study Design that enrolled and met all eligibility prior to Lead placement with imputed data for missed visits. Covarities in the imputation model included age, gender, ethnicity, race, time since amputation, location of amputation, and baseline average pain intensity score(s).|||Participants|||Count of Participants
2615838|NCT01996254|Secondary|Proportion of Subjects That Experienced ≥ 50% Reduction in All Qualifying Areas of Pain at Months 3-12 Post-Start of Treatment|Subjects were asked to recall and rate their average pain intensity over the past week (BPI-SF question 5) for each qualifying area of pain (phantom and/or residual limb pain) on a scale from 0 to 10, where 0 indicates no pain and 10 indicates pain as bad as you can imagine. The average pain intensity score(s) at baseline were compared to the same region(s) of pain at monthly intervals from months 3-12 post-start of treatment (SOT). Subjects that achieved ≥ 50% reduction in their qualifying area(s) of pain were considered successful. Certain time points for Group 2 (i.e., after crossover) were considered exploratory, but are reported with this outcome measure for ease of data entry and readability.|3-months Post-SOT, 4-months Post-SOT, 5-months Post-SOT, 6-months Post-SOT, 7-months Post-SOT, 8-months Post-SOT, 9-months Post-SOT, 10-months Post-SOT, 11-months Post-SOT, and 12-months Post-SOT|Long Term Analysis Set: Subjects from the Revised Study Design that enrolled and met all eligibility prior to Lead placement with imputed data for missed visits. Covarities in the imputation model included age, gender, ethnicity, race, time since amputation, location of amputation, and baseline average pain intensity score(s).|||Participants|||Count of Participants
2615839|NCT01996254|Secondary|Number of Group 1 (Treatment) Subjects That Experienced ≥ 50% Reduction in All Qualifying Areas of Pain During Weeks 5-8 Compared to Group 2 (Control) Subjects During Weeks 1-4|Subjects completed daily diaries to record their average daily pain intensity scores for each qualifying region of pain (phantom limb pain and/or residual limb pain). These pain intensity questions were excerpted from the Brief Pain Inventory - Short Form Question 5 (BPI-5) on a scale from 0 to 10, where 0 indicates no pain and 10 indicates pain as bad as you can imagine. Post-amputation pain intensity scores were determined by taking the mean of the daily average pain intensity scores at baseline and over weeks 5-8 post-start of treatment for Group 1 subjects and over weeks 1-4 post-start of treatment for Group 2 subjects. Subjects that achieved ≥ 50% reduction in their qualifying area(s) of pain were considered successful. Missing diary data were replaced using the bi-weekly BPI-5 recall scores; if unavailable, the BPI-5 recall from the follow-up visit was used. The number of successes in each group is reported.|Baseline and Weeks 1-8 Post-Start of Treatment|Full Analysis Set: Subjects from the Revised Study Design that enrolled and met all eligibility prior to Lead placement.|||Participants|||Count of Participants
2615861|NCT01995838|Secondary|Percentage of Participants With Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)||TEAEs: Baseline up to Day 30, SAEs: Baseline up to 30 days after last dose of study drug (up to 47 days)|The safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.|||percentage of participants|||Number
2615840|NCT01996254|Primary|Number of Subjects That Experienced at Least One Study-Related Adverse Event in Treatment and Control Groups|At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition had occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.|Each participant enrolled was assessed for adverse events from the time of informed consent through the 12-month follow up visit. The total assessment period was approximately 13 months for each participant.|Safety Set: All subjects that underwent Lead placement.|||Participants|||Count of Participants
2615841|NCT01996254|Primary|Proportion of Group 1 (Treatment) and Group 2 (Control) Subjects That Achieved ≥ 50% Reduction in All Qualifying Areas of Pain in the First 4 Weeks of Treatment|"Subjects completed daily diaries to record their average daily pain intensity scores for each qualifying region of pain (phantom limb pain and/or residual limb pain). These pain intensity questions were excerpted from the Brief Pain Inventory - Short Form Question 5 (BPI-5). The BPI-5 is an 11-point numerical rating scale where 0 represents No Pain and 10 represents Pain as bad as you can imagine. Post-amputation pain intensity scores were determined for each subject by taking the mean of the daily average pain intensity scores from their diaries at Baseline compared to the mean score for the same region(s) of pain reported over 4 weeks after the Start of Treatment (i.e., the average of all diary scores during this period). Subjects that achieved ≥ 50% reduction in their qualifying area(s) of pain were considered successful. Missing diary data were replaced using 1-week BPI-5 recall; if recall scores were unavailable, baseline values were imputed."|Baseline and Weeks 1-4 Post-Start of Treatment|Full Analysis Set: Subjects who were consented, randomized, and met all eligibility criteria prior to Lead placement|||Participants|||Count of Participants
2615842|NCT01996241|Secondary|Number of Participants Married and Co-habiting With Husband [by Trial End Line]|This outcome will be assessed using data collected from all study participants at end-line, using the face-to-face questionnaire.|May-August 2016 (cohort one) and May-August 2017 (cohort two)||||Participants|||Count of Participants
2615843|NCT01996241|Secondary|Number of Participants Having Sexual Debut [by Trial End Line]|This outcome will be assessed using data collected from all study participants at end-line, using the self-completed questionnaire.|May-August 2016 (cohort one) and May-August 2017 (cohort two)||||Participants|||Count of Participants
2615844|NCT01996241|Secondary|Number of Participants Passing 10th Standard [Pass 10th Standard Exam]|This outcome will be assessed using data collected from all study participants at end-line, using the face-to-face questionnaire.|May-August 2016 (cohort one) and May-August 2017 (cohort two)||||Participants|||Count of Participants
2615845|NCT01996241|Secondary|Number of Participants Entering Into 8th Standard [Start Secondary School]|Due to delays at the start of the cluster-Randomized Controlled Trial, the intervention had not started when cohort one girls were interviewed. This outcome will be assessed using data from cohort two girls only, using the face-to-face questionnaire. To reduce recall bias, we will use data collected at the first interview (baseline) to measure this outcome.|March-May 2014|outcome assessed using data from cohort two girls only, using the baseline face-to-face questionnaire.|||Participants|||Count of Participants
2615846|NCT01996241|Primary|Number of Participants Married [by Trial End Line]|This outcome will be assessed using data collected from all study participants at end-line, using the face-to-face questionnaire.|May-August 2016 (cohort one) and May-August 2017 (cohort two)||||Participants|||Count of Participants
2615847|NCT01996241|Primary|Number of Participants Completing Secondary School [Sit 10th Standard Exam]|This outcome will be assessed using data collected from all study participants at end-line, using the face-to-face questionnaire.|May-August 2016 (cohort one) and May-August 2017 (cohort two)||||Participants|||Count of Participants
2615848|NCT01996033|Other Pre-specified|Change in Estimated Glomerular Filtration Rate (eGFR)|Change from baseline in eGFR|12 Months|Subjects with both baseline and follow up data available|||mL/min per 1.73m2||Standard Deviation|Mean
2615849|NCT01996033|Other Pre-specified|Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure|Positive number indicates a reduction (improvement) in blood pressure|12 Months|Subjects with baseline and follow up data available|||Participants|||Count of Participants
2615850|NCT01996033|Other Pre-specified|Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure|Positive number indicates a reduction (improvement) in blood pressure|6 Months|Subjects with baseline and follow up data available|||Participants|||Count of Participants
2615851|NCT01996033|Other Pre-specified|Proportion of Subjects Achieving <140mmHg Office Systolic Blood Pressure|Positive number indicates a reduction (improvement) in blood pressure|1 Month|Subjects with baseline and follow up data available|||Participants|||Count of Participants
2615852|NCT01996033|Other Pre-specified|Reduction in 24 Hour Ambulatory Diastolic Blood Pressure|Positive number indicates a reduction (improvement) in blood pressure|12 Months|Subjects with baseline and follow up data available|||mmHg||Standard Deviation|Mean
2615853|NCT01996033|Other Pre-specified|Reduction in 24 Hour Ambulatory Systolic Blood Pressure|Positive number indicates a reduction (improvement) in blood pressure|12 Months|Subjects with baseline and follow up data available|||mmHg||Standard Deviation|Mean
2615854|NCT01996033|Other Pre-specified|Reduction in Office Systolic Blood Pressure|Positive number indicates a reduction (improvement) in blood pressure|12 Months|Subjects with baseline and follow up data available|||mmHg||Standard Deviation|Mean
2615855|NCT01996033|Other Pre-specified|Reduction in Office Diastolic Blood Pressure|Positive number indicates a reduction (improvement) in blood pressure|12 Months|Subjects with baseline and follow up data available|||mmHg||Standard Deviation|Mean
2615856|NCT01996033|Other Pre-specified|Reduction in Office Diastolic Blood Pressure|Positive number indicates a reduction (improvement) in blood pressure|6 Months|Subjects with baseline and follow up data available|||mmHg||Standard Deviation|Mean
2615857|NCT01996033|Primary|Mean Reduction in Office Systolic Blood Pressure at 6 Months|Positive number indicates a reduction (improvement) in blood pressure|6 months|All subjects with data available at baseline and 6-month follow up|||mmHg||Standard Deviation|Mean
2615858|NCT01995838|Secondary|Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECGs)||Baseline up to Day 30|The safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||participants|||Number
2615862|NCT01995838|Secondary|Rebound Insomnia: Mean Change From Baseline in Sleep Efficiency (SE) After Dosing on Days 16-17|Rebound insomnia was assessed by comparing the change from baseline of the mean SE on Days 16-17. Sleep efficiency was calculated as total sleep time divided by time spent in bed multiplied by 100. An increase in SE indicated improvement in sleeping, such that, the participant spends more time in bed asleep. A negative change from baseline in SE indicated that SE was worse on Days 16 and 17 than at Baseline, which was considered as evidence for rebound insomnia.|Baseline and Days 16-17|The FAS included all participants who were randomized, received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, number of participants analyzed (N) represents participants who were available for analysis at the specified timepoint.|||percentage of sleep time||Standard Error|Least Squares Mean
2615863|NCT01995838|Secondary|Potential Habituation Effect: Comparison Between Mean Change From Baseline in Wakefulness After Sleep Onset (WASO) on Days 1-2 and Mean Change From Baseline in WASO on Days 14-15|Potential habituation effect evaluated the possibility of participants being habituated to changes in sleep during the 15 days of treatment with lemborexant. Data reported here was calculated as change from baseline of mean WASO of Days 14-15 minus change from baseline of mean WASO of Days 1-2. WASO was calculated as minutes of wakefulness from the onset of persistent sleep until lights on. A decrease in WASO indicated improvement in sleep maintenance.|Baseline, Days 1-2, and Days 14-15|The FAS included all participants who were randomized, received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.|||minutes||Standard Deviation|Mean
2615864|NCT01995838|Secondary|Potential Habituation Effect: Comparison Between Mean Change From Baseline in Latency to Persistent Sleep (LPS) on Days 1-2 and Mean Change From Baseline in LPS on Days 14-15|Potential habituation effect evaluated the possibility of participants being habituated to changes in sleep during the 15 days of treatment with lemborexant. Data reported here was calculated as change from baseline of mean LPS of Days 14-15 minus change from baseline of mean LPS of Days 1-2. LPS was calculated as minutes from lights off to the first 30-second epoch of 20 consecutive epochs of non-wakefulness. A decrease in LPS indicated improvement in time needed to fall asleep.|Baseline and Days 1-2, and Days 14-15|The FAS included all participants who were randomized, received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.|||minutes||Standard Deviation|Mean
2615865|NCT01995838|Secondary|Potential Habituation Effect: Comparison Between Mean Change From Baseline in SE on Days 1-2 and Mean Change From Baseline in SE on Days 14-15|Potential habituation effect evaluated the possibility of participants being habituated to changes in sleep during the 15 days of treatment with lemborexant. Data reported here was calculated as change from baseline of mean SE of Days 14-15 minus change from baseline of mean SE of Days 1-2. An increase in SE indicated improvement in sleeping, such that, the participant spends more time in bed asleep.|Baseline, Days 1-2, and Days 14-15|The FAS included all participants who were randomized, received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percentage of sleep time||Standard Deviation|Mean
2615866|NCT01995838|Secondary|Mean Change From Baseline in Wakefulness After Sleep Onset (WASO) After Dosing on Days 1-2 and Days 14-15|WASO was calculated as minutes of wakefulness from the onset of persistent sleep until lights on. A decrease in WASO indicated improvement in sleep maintenance. Mean scores of Days 1-2 and Days 14-15 were used to evaluate change from baseline.|Baseline, Days 1-2, and Days 14-15|The FAS included all participants who were randomized, received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, number of participants analyzed (N) represents participants who were available for analysis at the specified timepoints.|||minutes||Standard Error|Least Squares Mean
2615867|NCT01995838|Secondary|Mean Change From Baseline in Latency to Persistent Sleep (LPS) After Dosing on Days 1-2 and Days 14-15|LPS was calculated as minutes from lights off to the first 30-second epoch of 20 consecutive epochs of non-wakefulness. A decrease in LPS indicated improvement in time needed to fall asleep. Mean scores of Days 1-2 and Days 14-15 were used to evaluate change from baseline.|Baseline, Days 1-2, and Days 14-15|The FAS included all participants who were randomized, received at least 1 dose of study drug, had at least 1 post-dose primary efficacy measurement with both baseline and post baseline data available for analysis at each timepoints.|||minutes||Standard Deviation|Mean
2615868|NCT01995838|Secondary|Mean Change From Baseline in Sleep Efficiency (SE) After Dosing on Days 1-2 and Days 14-15|Sleep efficiency was calculated as total sleep time divided by time spent in bed multiplied by 100. An increase in SE indicated improvement in sleeping, such that, the participant spends more time in bed asleep. Mean scores of Days 1-2 and Days 14-15 were used to evaluate change from baseline.|Baseline, Days 1-2, and Days 14-15|The FAS included all participants who were randomized, received at least 1 dose of study drug, had at least 1 post-dose primary efficacy measurement with both baseline and post baseline data available for analysis at each timepoints.|||percentage of sleep time||Standard Error|Least Squares Mean
2615869|NCT01995838|Primary|Mean Change From Baseline in Karolinska Sleepiness Scale (KSS) Score at End of Treatment|The KSS was used to measure next-day residual effects at prespecified time points. The KSS was a 9-point scale on which the participant rated their sleepiness from 1 (extremely alert) to 9 (extremely sleepy/fighting sleep), where higher scores indicated an increase in sleepiness. The end of treatment score was calculated by the mean scores at the timepoint at 1 hour after morning wake time of Day 15 and 16.|1 hour after morning wake time at Baseline and Days 15-16|The FAS included all participants who were randomized, received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement. Here, number of participants analyzed (N) represents participants who were available for analysis at the specified timepoints.|||Units on a scale||Standard Error|Least Squares Mean
2615898|NCT01995461|Secondary|Change From Baseline Oswestry Disability Index at 6 Months|The 2 questions from this Index pertaining to Standing and Walking are being utilized to assess changes in duration of standing and walking in these patients. The two sections of the Oswestry Disability Index (ODI) used in the present study were those related to walking and standing (sections 4 and 6). For each section, the total possible score is 5 and overall ODI score was expressed as a percentage of the maximum possible score (10). Total score increases with worsening disability.|baseline (pre-1st injection) to 6 months post-1st injection||||points||95% Confidence Interval|Mean
2615870|NCT01995838|Primary|Probability of Having Utility Function Greater Than (>) 1 Based on Bayesian Analysis|The utility of a dose was a function of both Sleep Efficiency (SE) and Karolinska Sleepiness Scale (KSS), constructed by specifying the 1-dimensional component for each outcome measure and then combining them multiplicatively. Sufficient utility was defined as a probability of having utility function >1. Probability of having utility function >1 at the end of study visit (full analysis) was reported.|Baseline up to Day 3|The full analysis set (FAS) included all participants who were randomized, received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement.|||probability|||Number
2615871|NCT01995552|Secondary|Determine Percentage of Patients With Non-lethal Arrhythmias on ELR Post MI Have a Higher Risk of All-cause Mortality at 1 Year|"Analysis included all patients that completed the acute monitoring period. Based on the arrhythmias detected during the acute ELR monitoring period, patients were classified as with arrhythmia when during the ELR monitoring period there is any episode of ELR monitored events listed. All other patients are classified without arrhythmia. Mortality rates after the monitoring period was estimated for both groups."|12 Months|There were total 28 deaths reported|||percentage of Mortality||95% Confidence Interval|Number
2615872|NCT01995552|Primary|The Primary Objective of the Study is to Assess Percent of Participants With Clinically Significant Arrhythmias on ELR Post MI|Post MI mortality is higher in India than in the US and Western Europe. The hypothesis of the INSPIRE-ELR study was that occurrence of arrhythmias in the acute phase of MI will identify patients at highest risk and we evaluated the percentage clinical signification arrhythmias captured through the ELR post MI in acute phase|7 days post discharge||||percentage of analyzed population||95% Confidence Interval|Number
2615873|NCT01995539|Secondary|Number of Serious Adverse Device Effects (SADE).|Evaluation of incidence of SADE during the study.|3 months||||events|||Number
2615874|NCT01995539|Primary|Change From Baseline in A1C at 3 Months|Descriptive analysis of change in A1C from baseline to end of 3-month study period|3 months|181 subjects consented and screened; 1 subject screen failed; 148 subjects completed study; 32 subjects not completed study.|||percent||Standard Deviation|Mean
2615875|NCT01995526|Primary|Glucodynamics: Total Amount of Glucose Infused (Gtot)||Predose up to 36 hours post clamp procedure.|All participants who received insulin peglispro and had evaluable Gtot data.|||milligrams/kilograms (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
2615876|NCT01995526|Primary|Glucodynamics: Maximum Glucose Infusion Rate (Rmax)||Predose up to 36 hours post clamp procedure|All participants who received insulin peglispro and had evaluable Rmax data.|||milligrams/minute/kilogram (mg/min/kg)||Geometric Coefficient of Variation|Geometric Mean
2615877|NCT01995526|Primary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Insulin Peglispro||Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose|All participants who received insulin peglispro and had evaluable Tmax data.|||hours||Full Range|Median
2615878|NCT01995526|Primary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of Insulin Peglispro|AUC from time zero to infinity (AUC[0-∞]) of insulin peglispro was evaluated.|Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose|All participants who received insulin peglispro and had evaluable AUC(0-∞) data.|||picomoles*hours/liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2615879|NCT01995526|Primary|Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro||Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose|All participants who received insulin peglispro and had evaluable Cmax data.|||picomoles/liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
2615880|NCT01995513|Other Pre-specified|Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.|Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to data cutoff date [07 Oct 2016])|Safety population included all participants who received any amount of study drug.|||percentage of participants|||Number
2615881|NCT01995513|Other Pre-specified|Percentage of Participants With Adverse Events (AEs) Leading to Death|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'.|Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to data cutoff date [07 Oct 2016])|Safety population included all participants who received any amount of study drug.|||percentage of participants|||Number
2615882|NCT01995513|Other Pre-specified|Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'.|Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to data cutoff date [07 Oct 2016])|Safety population included all participants who received any amount of study drug.|||percentage of participants|||Number
2615913|NCT01995201|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) up to Week 24|The symptom-specific measure FACIT-F assesses chronic illness therapy with special emphasis on fatigue in the past 7 days and consists of 5 dimensions: 1) physical well- being, 2) social/family well-being, 3) emotional well-being, 4) functional well-being, and 5) additional concerns. Each of the questions is categorically answered using the scales 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much for a total possible FACIT-F score of 0 to 160. The figures are reversed during score calculations, so that higher score values indicate more favorable conditions.|From baseline to Week 24|Analysis was conducted on the FAS|||FACIT-F score||Standard Deviation|Mean
2615883|NCT01995513|Other Pre-specified|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious.|Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (up to data cutoff date [07 Oct 2016])|Safety population included all participants who received any amount of study drug.|||percentage of participants|||Number
2615884|NCT01995513|Secondary|Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score|Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 with higher scores representing better quality of life. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation.|From randomization up to data cutoff date (07 Oct 2016)|Evaluable ITT population included all participants with a PSA value at baseline of Period 2 and at least 1 post baseline assessment.|||months||95% Confidence Interval|Median
2615885|NCT01995513|Secondary|Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores|The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for physical well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life.|Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89|ITT population included all participants randomly assigned to study treatment. Here, n signifies those participants who were evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
2615886|NCT01995513|Secondary|Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores|The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for prostate cancer domain is from 0 (worst response) to 48 (best response), where higher score indicated better quality of life with fewer symptoms.|Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89|ITT population included all participants randomly assigned to study treatment. Here, n signifies those participants who were evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
2615887|NCT01995513|Secondary|Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores|The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for functional well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life.|Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89|ITT population included all participants randomly assigned to study treatment. Here, n signifies those participants who were evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
2615888|NCT01995513|Secondary|Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores|The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for emotional well-being domain is from 0 (worst response) to 24 (best response), where higher score indicate better quality of life.|Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89|ITT population included all participants randomly assigned to study treatment. Here, n signifies those participants who were evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
2615889|NCT01995513|Secondary|Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores|The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for social/family well-being domain is from 0 (worst response) to 32 (best response), where higher score indicate better quality of life.|Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89|ITT population included all participants randomly assigned to study treatment. Here, n signifies those participants who were evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
2615890|NCT01995513|Secondary|Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score|The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 where higher scores represent better quality of life.|Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89|ITT population included all participants randomly assigned to study treatment. Here, number analyzed (n) signifies those participants who were evaluable at specified time points.|||units on a scale||Standard Deviation|Mean
2615891|NCT01995513|Secondary|Time to First Use of New Antineoplastic Therapy for Prostate Cancer|It was defined as time from randomization to the date of first use of subsequent antineoplastic therapy for prostate cancer. For participants who had not started subsequent antineoplastic therapy as of data analysis cutoff date, the time to first use of subsequent antineoplastic therapy was censored at the date of last assessment.|From randomization until date of first use of any antineoplastic therapy (after last dose date of Period 2, up to the data cutoff date [07 Oct 2016])|ITT population included all participants randomly assigned to study treatment.|||months||95% Confidence Interval|Median
2615892|NCT01995513|Secondary|Rate of Pain Progression|Rate of pain progression was defined as percentage of participants with an increase of >=30% from baseline in the mean Brief Pain Inventory-Short Form (BPI-SF) pain intensity item scores of 4 items assessing average, worst, least, and intermediate pain severity. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf score range for each item was from 0=no pain to 10=worst possible pain. Total score was reported as average of individual questions ranges from 0 to 10, where lower scores indicated less pain or less pain interference.|Month 6|ITT population included all participants randomly assigned to study treatment. Here, N signifies those participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2615893|NCT01995513|Secondary|Objective Response Rate (ORR)|Objective response rate as assessed by the investigator according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1) was defined as 1) Percentage of participants with confirmed best overall complete response (CR) and partial response (PR); 2) Percentage of participants with CR, PR and stable disease (SD) for target lesions or non-progressive disease for non-target lesions. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to <10 millimeter (mm) in short axis. No new lesions and disappearance of all non-target lesions. PR: >= 30% decrease in sum of diameters of target lesions, compared to the sum at baseline. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.|From randomization until CR or PR, whichever occurred first (up to the data cutoff date [07 Oct 2016])|ITT population (with measurable disease at screening) included all subjects randomly assigned to study treatment. Here, N signifies those participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2615894|NCT01995513|Secondary|Prostate Specific Antigen (PSA) Response Rate|PSA response rate was defined as percentage of participants with >=30% and >=50% decrease in PSA from baseline at randomization to the maximal PSA response with a threshold of 30% and 50% respectively. PSA response was confirmed if another assessment measured at least 3 weeks later met the criterion as well.|From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (up to the data cutoff date [07 Oct 2016])|Evaluable ITT population included all participants with a PSA value at baseline of Period 2 and at least 1 post baseline assessment. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2615895|NCT01995513|Secondary|Time to Prostate Specific Antigen (PSA) Progression|Time from date of randomization to the date of first confirmed PSA progression as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2). For participant's whose PSA decreased at Week 13 after randomization, progression was defined as 25 percent (%) PSA increase relative to nadir or absolute increase of >=2 nanogram/milliliter (ng/mL) above nadir. Progression was confirmed if another assessment measured at least 3 weeks later met the criterion as well. For participant's whose PSA did not decrease at Week 13 after randomization, progression was defined as 25% PSA increase relative to baseline assessed 12 weeks after baseline. Participants who were not known to have had a PFS event at the analysis date were censored at last PSA assessment date prior to data cutoff date.|From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (up to the data cutoff date [07 Oct 2016])|ITT population included all participants randomly assigned to study treatment.|||months||95% Confidence Interval|Median
2615896|NCT01995513|Primary|Progression Free Survival (PFS)|PFS = time from randomization to first documentation of radiographic progression (RP),unequivocal clinical progression or death due to any cause (death within 112 days of treatment discontinuation without objective evidence of RP),whichever occurred first as per investigator. Unequivocal disease progression was pain requiring chronic administration of analgesics, decline of prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to 3 or higher or initiation of new anticancer therapy/radiation therapy or surgical intervention due to tumor progression. ECOG score range= 0(no severity) to 5(maximum severity).RP for bone disease was evaluated by appearance of 2 or more new bone lesions as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2) or for soft tissue disease according to Response Evaluation Criteria in Solid Tumor version 1.1. Participants with no PFS event at analysis date were censored at last tumor assessment date prior to data cutoff date.|From randomization until disease progression, last tumor assessment without disease progression or death due to any cause, whichever occurred first (up to the data cutoff date [07 Oct 2016])|ITT population included all participants randomly assigned to study treatment.|||months||95% Confidence Interval|Median
2615897|NCT01995461|Other Pre-specified|Change From Baseline Pain Medication Need/Use at 6 Months||baseline (pre-1st injection) to 6 months post-1st injection|||||||
2615899|NCT01995461|Secondary|Change From Baseline Swiss Spinal Stenosis Score at 6 Months|The Swiss spinal stenosis score is a questionnaire composed of 18 multiple choice questions designed to give information as to how the patient's back and leg pain is affecting their ability to manage everyday life. The Swiss spinal stenosis (SSS) questionnaire consists of 12 baseline questions asked of all participants prior to injection and an additional 6 questions asked at each time point post-treatment. The initial 12 questions assess reliability and condition at baseline while the 6 post-treatment questions assess treatment satisfaction. All questions ask the patient to assess symptoms over the previous month with a total maximum score for the initial 12 questions of 53 and a total maximum score of 24 for the 6 additional questions. The final total score is expressed as a percentage of the maximum possible score. Total score increases with worsening disability.|baseline (pre-1st injection) to 6 months post-1st injection||||points||95% Confidence Interval|Mean
2615900|NCT01995461|Primary|Change From Baseline Pain Score at 6 Months|change from baseline (pre-1st injection) pain score, based on a numeric pain scale of 0-10(most severe pain), at 6 months post-1st injection|baseline (pre-1st injection) to 6 months post-1st injection||||points||95% Confidence Interval|Mean
2615901|NCT01995357|Primary|Degree of Leakage|"The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage).~Results are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group."|10 (- 2 days)||||units on a scale||Standard Deviation|Mean
2615902|NCT01995266|Secondary|Number of Participants With Virologic Response (VR) at Treatment Week 4 and 12|VR was defined as HCV RNA < LLOQ, target detected or not detected at specific time points (Week 4 and Week 12)|Treatment Week 4 and 12|All treated and evaluable participants.|||Participants|||Count of Participants
2615903|NCT01995266|Secondary|Number of Participants With HCV RNA < LLOQ Target Detected or Not Detected at the End of Treatment (Week 24)|Antiviral efficacy is measured by the number of participants with HCV RNA< LLOQ (lower limit of quantification), TD (target detected) or TND (target not detected) at End of Treatment (Week 24)|Week 24 (End-of Treatment)|All treated and evaluable participants.|||Participants|||Count of Participants
2615904|NCT01995266|Secondary|Number of Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as HCV RNA < LLOQ, target not detected at treatment Weeks 4 and 12.|Treatment Week 4 and Week 12|All treated and evaluable participants.|||Participants|||Count of Participants
2615905|NCT01995266|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as HCV RNA < LLOQ, target not detected at treatment Week 12.|Treatment Week 12|All treated and evaluable participants.|||Percentage of participants||95% Confidence Interval|Number
2615906|NCT01995266|Secondary|Number of Participants With Rapid Virologic Response (RVR)|RVR was defined as HCV RNA < LLOQ, target not detected at treatment Week 4.|Treatment Week 4|All treated and evaluable participants.|||Participants|||Count of Participants
2615907|NCT01995266|Secondary|Percentage of Participants With HCV RNA< LLOQ Target Not Detected at the End of Treatment (Week 24)|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0. The lower and upper limits of quantitation (LOQs) of the assay for HCV GT-1 were 25 IU/mL and 3.91 X10^8 IU/mL, respectively; the limit of detection was ~ 10 IU/mL|Week 24 (End-of Treatment)|All treated and evaluable participants.|||Percentage of participants||95% Confidence Interval|Number
2615908|NCT01995266|Secondary|Percentage of Participants With SVR24 by the rs12979860 Single Nucleotide Polymorphisms (SNP) in the IL 28B Gene at Post-Treatment Follow-up Week 24|Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 24.|24 Weeks after treatment discontinuation (Follow-up Week 24)|All evaluable participants of each Genotype who received treatment|||Percentage of participants|||Number
2615909|NCT01995266|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Death, and AEs Leading to Discontinuation|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event.|7 days after treatment discontinuation|All treated and evaluable participants.|||Participants|||Count of Participants
2615910|NCT01995266|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 12 (SVR12)|SVR12 was defined as HCV RNA < LLOQ target detected or not detected at post-treatment follow-up Week 12. For SVR12, missing HCV RNA data at follow-up Week 12 was imputed using the Next Value Carried Backwards (NVCB) approach.|12 Weeks after treatment discontinuation (Follow-up Week 12)|All treated and evaluable participants.|||Percentage of participants||95% Confidence Interval|Number
2615911|NCT01995266|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 24 (SVR24)|SVR was defined as Hepatitis C Virus ribonucleic acid (HCV RNA) < lower limit of quantitation (LLOQ) target detected (TD) or not detected (TND) at post-treatment follow-up Week 24.|24 Weeks after treatment discontinuation (Follow-up Week 24)|All treated and evaluable participants.|||Percentage of participants||95% Confidence Interval|Number
2615912|NCT01995201|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) up to Week 48|The symptom-specific measure FACIT-F assesses chronic illness therapy with special emphasis on fatigue in the past 7 days and consists of 5 dimensions: 1) physical well- being, 2) social/family well-being, 3) emotional well-being, 4) functional well-being, and 5) additional concerns. Each of the questions is categorically answered using the scales 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much for a total possible FACIT-F score of 0 to 160. The figures are reversed during score calculations, so that higher score values indicate more favorable conditions.|Baseline, from week 28 until week 48|Analysis was conducted on the FAS.|||FACIT-F score||Standard Deviation|Mean
2615914|NCT01995201|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) up to Week 48|"The Stanford HAQ-DI is a patient-oriented outcome assessment questionnaire specific for RA. It consists of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.~To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3."|Baseline, from week 28 until week 48|Analysis was conducted on the FAS.|||HAQ-DI score||Standard Deviation|Mean
2615915|NCT01995201|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) up to Week 24|"The Stanford HAQ-DI is a patient-oriented outcome assessment questionnaire specific for RA. It consists of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities.~To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3."|From baseline to Week 24|Analysis was conducted on the FAS.|||HAQ-DI score||Standard Deviation|Mean
2615916|NCT01995201|Secondary|Assessment of Pain Reported by the Patient (VAS) Until Week 48|"This patient reported outcome assessment represents the patient's assessment of his/her current level of pain on a 100 mm horizontal VAS. The extreme left end of the line should be described as no pain and the extreme right end as unbearable pain."|Baseline, from week 28 until week 48|Analysis was conducted on the FAS.|||Millimeters||Standard Deviation|Mean
2615917|NCT01995201|Secondary|Assessment of Pain Reported by the Patient (VAS) Until Week 24|"This patient reported outcome assessment represents the patient's assessment of his/her current level of pain on a 100 mm horizontal VAS. The extreme left end of the line should be described as no pain and the extreme right end as unbearable pain."|From baseline to Week 24|Analysis was conducted on the FAS.|||Millimeters||Standard Deviation|Mean
2615918|NCT01995201|Secondary|Patient Global Assessment of Disease Activity Visual Analogue Scale (VAS) up to Week 48|"This patient reported outcome assessment represents the patient's overall assessment of their current disease activity on a 100 mm horizontal VAS. The extreme left end of the line should be described as no disease activity (symptom-free and no arthritis symptoms) and the extreme right end as maximum disease activity (maximum arthritis disease activity). The line was marked by the participant and the distance from the left edge was recorded and the mean values are reported."|Baseline, from week 28 until week 48|Analysis was conducted on the FAS.|||Millimeters||Standard Deviation|Mean
2615919|NCT01995201|Secondary|Patient Global Assessment of Disease Activity Visual Analogue Scale (VAS) up to Week 24|"This patient reported outcome assessment represents the patient's overall assessment of their current disease activity on a 100 mm horizontal VAS. The extreme left end of the line should be described as no disease activity (symptom-free and no arthritis symptoms) and the extreme right end as maximum disease activity (maximum arthritis disease activity). The line was marked by the participant and the distance from the left edge was recorded and the mean values are reported."|From baseline to Week 24|Analysis was conducted on the FAS.|||Millimeters||Standard Deviation|Mean
2615920|NCT01995201|Secondary|Immunogenicity: SIL-6R Levels at Week 36 and Early Withdrawal Visit|Mean concentration of SIL-6R in patients' blood are reported.|Baseline, Week 36 and Early Withdrawal Visit|Analysis was conducted on the FAS.|||mcg/ml||Standard Deviation|Mean
2615921|NCT01995201|Secondary|Immunogenicity: SIL-6R Levels up to Week 24|Mean concentration of SIL-6R in patients' blood are reported.|From baseline to Week 24|Analysis was conducted on the FAS.|||mcg/ml||Standard Deviation|Mean
2615922|NCT01995201|Secondary|Immunogenicity: TCZ Levels at Week 36 and Early Withdrawal Visit|Mean concentrations of TCZ in patients' blood are reported.|week 36 and early withdrawal visit|Analysis was conducted on the FAS.|||mcg/ml||Standard Deviation|Mean
2615923|NCT01995201|Secondary|Immunogenicity: TCZ Levels up to Week 24|Mean concentrations of TCZ in patients' blood are reported.|From baseline to Week 24|Analysis was conducted on the FAS.|||mcg/ml||Standard Deviation|Mean
2615924|NCT01995201|Secondary|Immunogenicity: Number of Patients With Anti-tocilizumab Antibodies up to Week 48|Number of patients resulting positive to anti-tocilizumab antibodies test are reported.|From week 24 until week 48|Analysis was conducted on the FAS.|||Number of participants|||Number
2615925|NCT01995201|Secondary|Immunogenicity: Number of Patients With Anti-tocilizumab Antibodies up to Week 24|Number of patients resulting positive to anti-tocilizumab antibodies test are reported.|From baseline to Week 24|Analysis was conducted on the FAS.|||Number of participants|||Number
2615926|NCT01995201|Secondary|Safety: Number of Patients Reporting Adverse Events up to Week 48|Number of patients reporting any treatment emergent adverse event (TEAE), at least one TEAE of special interest, at least one serious TEAE, at least one TEAE leading to dose modification, at least one TEAE leading to discontinuation up to week 48|From week 24 until week 48|Analysis was conducted on the FAS.|||Number of participants|||Number
2615927|NCT01995201|Secondary|Safety: Number of Patients Reporting Adverse Events up to Week 24|Number of patients reporting any treatment emergent adverse event (TEAE), at least one TEAE of special interest, at least one serious TEAE, at least one TEAE leading to dose modification, at least one TEAE leading to discontinuation up to week 24|From baseline to Week 24|Analysis was conducted on the FAS.|||Number of participants|||Number
2615928|NCT01995201|Secondary|Percentage of Patients Who Achieved Low Disease Activity (LDA) Based on SDAI Score (SDAI<11) Until Week 48|Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity.|From week 28 until week 48|Analysis was conducted on the FAS.|||Percentage of participants||95% Confidence Interval|Number
2617048|NCT01984424|Secondary|Percent Change From Baseline in Total Cholesterol at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
2615929|NCT01995201|Secondary|Percentage of Patients Who Achieved Low Disease Activity (LDA) Based on SDAI Score (SDAI<11) Until Week 24|Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity.|From baseline to Week 24|Analysis was conducted on the FAS.|||Percentage of participants||95% Confidence Interval|Number
2615930|NCT01995201|Secondary|Percentage of Patients Who Achieve Low Disease Activity Based on CDAI Score (CDAI<10) Until Week 48|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement.|From week 28 until week 48|Analysis was conducted on the FAS.|||Percentage of participants||95% Confidence Interval|Number
2615931|NCT01995201|Secondary|Percentage of Patients Who Achieve Low Disease Activity Based on CDAI Score (CDAI<10) Until Week 24|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement.|From baseline to Week 24|Analysis was conducted on the FAS.|||Percentage of participants||95% Confidence Interval|Number
2615932|NCT01995201|Secondary|Percentage of Patients Who Achieve Low Disease Activity Based on DAS28-ESR Criteria (DAS28-ESR </=3.2) up to Week 48|The DAS28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP), and general health status. For this study ESR was used to calculate the DAS28 score.|From week 28 until week 48|Analysis was conducted on the FAS.|||Percentage of participants||95% Confidence Interval|Number
2615933|NCT01995201|Secondary|Percentage of Patients Who Achieve Low Disease Activity Based on DAS28-ESR Criteria (DAS28-ESR </=3.2) up to Week 24|The DAS28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP), and general health status. For this study ESR is used to calculate the DAS28 score.|From baseline to Week 24|Analysis was conducted on the FAS.|||Percentage of participants||95% Confidence Interval|Number
2615934|NCT01995201|Secondary|Percentages of Patients With Remission (SDAI<3.3) Until Week 48|Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity.|From week 28 until week 48|Analysis was conducted on the FAS|||Percentage of participants||95% Confidence Interval|Number
2615935|NCT01995201|Secondary|Percentages of Patients With Remission (SDAI<3.3) Until Week 24|Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity.|From baseline to Week 24|Analysis was conducted on the FAS|||Percentage of participants||95% Confidence Interval|Number
2615936|NCT01995201|Secondary|Percentages of Patients With Remission (CDAI<2.8) Until Week 48|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement.|From week 28 until week 48|Analysis was conducted on the FAS|||Percentage of participants||95% Confidence Interval|Number
2615937|NCT01995201|Secondary|Percentages of Patients With Remission (CDAI<2.8) Until Week 24|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement.|From baseline to Week 24|Analysis was conducted on the FAS|||Percentage of participants||95% Confidence Interval|Number
2615938|NCT01995201|Secondary|Percentages of Patients Who Achieve DAS28-ESR Remission (DAS28 < 2.6) up to Week 48|The DAS 28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP) and general health status. For this study ESR was used to calculate the DAS 28 score.|Week 48|Analysis was conducted on the FAS|||Percentage of participants||95% Confidence Interval|Mean
2615939|NCT01995201|Secondary|Mean Change in Total Swollen Joint Counts (SJC) From Baseline Until Week 48|SJC is a clinical assessment of 66 joints classified as swollen/not swollen by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints will not be taken into consideration for swelling.|From week 24 until week 48|Analysis was conducted on the FAS.|||SJC||Standard Deviation|Mean
2615940|NCT01995201|Secondary|Mean Change in Total Swollen Joint Counts (SJC) From Baseline Until Week 24|SJC is a clinical assessment of 66 joints classified as swollen/not swollen by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints will not be taken into consideration for swelling.|From baseline to Week 24|Analysis was conducted on the FAS.SJC|||SJC||Standard Deviation|Mean
2615941|NCT01995201|Secondary|Mean Change From Baseline in Total Tender Joint Counts (TJC) Until Week 48|TCJ is a clinical assessment of 68 joints which are classified as tender/not tender by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints are not be taken into consideration.|From week 24 until week 48|Analysis was conducted on the FAS.|||TJC||Standard Deviation|Mean
2615942|NCT01995201|Secondary|Mean Change From Baseline in Total Tender Joint Counts (TJC) Until Week 24|TCJ is a clinical assessment of 68 joints which are classified as tender/not tender by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints are not be taken into consideration.|From baseline to Week 24|Analysis was conducted on the FAS.|||TJC||Standard Deviation|Mean
2615943|NCT01995201|Secondary|Mean Change in Simplified Disease Activity Index (SDAI) From Week 24 up to Week 48|Simplified Disease Activity Index (SDAI) which is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity.|From week 24 until week 48|Analysis was conducted on the FAS|||SDAI score||Standard Deviation|Mean
2615944|NCT01995201|Secondary|Mean Change in Simplified Disease Activity Index (SDAI) From Baseline up to Week 24|Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity.|From baseline to Week 24|Analysis was conducted on the FAS|||SDAI score||Standard Deviation|Mean
2615945|NCT01995201|Secondary|Mean Change From Baseline in Clinical Disease Activity Index (CDAI) up to Week 48|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement.|From week 24 until week 48|Analysis was conducted on the FAS.|||CDAI score||Standard Deviation|Mean
2615946|NCT01995201|Secondary|Mean Change in Clinical Disease Activity Index (CDAI) From Baseline up to Week 24|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement.|From baseline to Week 24|Analysis was conducted on the FAS.|||CDAI score||Standard Deviation|Mean
2615947|NCT01995201|Secondary|Number of Patients With Clinical Response According to European League Against Rheumatism (EULAR) Response Scores up to Week 48|DAS28-based EULAR response criteria were used to measure individual response as good or moderate depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to =<1.2 with DAS28 ≤5.1.|From week 28 until week 48|Analysis was conducted on the FAS.|||Number of participants|||Number
2615948|NCT01995201|Secondary|Number of Patients With Good and Moderate Clinical Response According to European League Against Rheumatism (EULAR) Response Scores up to Week 24|DAS28-based EULAR response criteria were used to measure individual response as good or moderate depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to =<1.2 with DAS28 ≤5.1.|From week 2 until week 24|Analysis was conducted on the FAS|||Number of participants|||Number
2615949|NCT01995201|Secondary|Percentage of Patients With American College of Rheumatology (ACR20, 50, 70, 90) Response Scores Until Week 48|The definition of improvement of ACR core set of outcome measures includes an improvement equal or higher to the 20%, 50%, 70%, 90% compared to Baseline in both Swollen Joint Count (SJC) and Tender Joint Count (TJC) as well as in three out of five additional parameters: Physician's Global Assessment of disease activity VAS, patient's Global Assessment of disease activity VAS, patient's assessment of pain VAS, HAQ-DI, and acute phase reactant (either CRP or erythrocyte sedimentation rate [ESR]).|From week 28 until week 48|Analysis was conducted on the FAS|||Percentage of participants||95% Confidence Interval|Number
2616010|NCT01994837|Secondary|Percentage of Participants Who Received Subsequent Stem Cell Transplant|The percentage of participants who received a subsequent allogenic (from a healthy donor) stem cell transplant was summarized.|When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier|All participants who received at least 1 dose of study drug|||percentage of participants|||Number
2615950|NCT01995201|Secondary|Percentage of Patients With American College of Rheumatology (ACR20, 50, 70, 90) Response Scores Until Week 24|The definition of improvement of ACR core set of outcome measures includes an improvement equal or higher to the 20%, 50%, 70%, 90% compared to Baseline in both Swollen Joint Count (SJC) and Tender Joint Count (TJC) as well as in three out of five additional parameters: Physician's Global Assessment of disease activity VAS, patient's Global Assessment of disease activity VAS, patient's assessment of pain VAS, HAQ-DI, and acute phase reactant (either CRP or erythrocyte sedimentation rate [ESR]).|From week 2 until week 24|Analysis was conducted on the FAS|||Percentage of participants||95% Confidence Interval|Number
2615951|NCT01995201|Secondary|Percentage of Patients Reporting Change in DAS 28 ESR >1.2 Until Week 48|The DAS28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP), and general health status. For this study ESR will be used to calculate the DAS28 score.|From week 28 up to week 48|Analysis was conducted on the FAS|||Percentage of participants||95% Confidence Interval|Number
2615952|NCT01995201|Secondary|Percentage of Patients Allocated in Groups A1 and A2 Who Remain With Clinical Remission Activity (DAS 28 ESR <2.6) up to Week 48|The DAS28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP), and general health status. For this study ESR will be used to calculate the DAS28 score.|From week 28 up to week 48|Analysis was conducted on the FAS|||Percentage of participants||95% Confidence Interval|Number
2615953|NCT01995201|Secondary|Mean Change in Disease Activity Score 28 - Erythrocyte Sedimentation Rate(DAS28-ESR)|The DAS 28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP) and general health status. For this study ESR was used to calculate the DAS 28 score.|From week 24 up to week 48|Analysis was conducted on the FAS|||mm/hr||Standard Deviation|Mean
2615954|NCT01995201|Primary|Percentage of Participants Achieving Sustained Clinical Remission, Disease Activity Scale 28 - Erythrocyte Sedimentation Rate <26 (DAS28-ESR <2.6) at Week 20 and Week 24|The DAS 28 is a combined index for measuring disease activity in RA. The index includes the assessment of 28 joints for swelling and tenderness, acute phase response (ESR or CRP) and general health status. For this study ESR was used to calculate the DAS 28 score.|Week 20 and Week 24|Analyses were conducted on the Full Analysis Set (FAS), i.e. all patients included in the study who received at least one dose of SC TCZ.|||Percentage of participants||95% Confidence Interval|Number
2615955|NCT01995175|Secondary|Number of Subjects With Medication Prescription for Wheeze or Asthma|Prescription of medications for wheeze or asthma in the extension phase corresponds to a specific request for relevant medication from parents, which may be supplemented by review of routine medical records or contact with health care provider.|From 2 years of age up to 6 years of age.||2022-12-31|12/2022||||
2615956|NCT01995175|Secondary|Number of Subjects With Wheeze or Asthma Requiring Admission|Wheeze or asthma requiring admission corresponds to, in the extension phase, a history from parents, which may be supplemented by review of routine medical records or contact with health care provider.|From 2 years of age up to 6 years of age.||2022-12-31|12/2022||||
2615957|NCT01995175|Secondary|Number of Subjects With Medically Attended Wheeze|Medically attended wheeze, corresponds, in the extension phase, to a history from parents solicited by contact every 3 months, which may be supplemented by review of routine medical records or contact with health care provider.|From 2 years of age up to 6 years of age.||2022-12-31|12/2022||||
2615958|NCT01995175|Secondary|Number of Subjects With WHO LRTI or Severe LRTI|LRTI refers to Child with RTI AND Blood Oxygen Saturation (SaO2) lower than (<) 95 percent (%), OR respiratory rate (RR) increase: higher than (>) 60/min < 2 months (m) of age; > 50/min 2-11m of age, 40/min 12-24m of age. Severe LRTI refers to Child with LRTI AND SaO2 < 92%, OR Difficulty breathing leading to: Irritability/agitation, OR Lethargy/sleepiness, OR Severe chest indrawing, OR Reduced/no vocalization, OR Apnoea > 20 sec, OR Cyanosis, OR Stop feeding well/dehydration.|From Month 1 up to Month 6 and from Month 13 up to Month 18.|The analysis was performed on the Per Protocol Set (PPS) which included all subjects enrolled in the primary cohort study meeting all eligibility criteria up to the time of their censoring, either at completion of epoch 1 or prematurely as drop-out (e.g. withdrawn consent, lost-to-follow-up).|||Participants|||Count of Participants
2615959|NCT01995175|Secondary|Levels of RSV-A and B Neutralizing Antibodies|Infant blood sample serum was tested for RSV neutralizing antibodies level detection.|At 2, 4, 6, 12, 18 and 24 months of age.||2019-12-31|12/2019||||
2615960|NCT01995175|Secondary|Levels of RSV-A and B Neutralizing Antibodies|Infant baseline blood sample serum was tested for detection of RSV neutralizing antibodies level.|At birth (Month 0)||2019-12-31|12/2019||||
2615961|NCT01995175|Primary|Number of RSV LRTI or Severe LRTI Episodes as Defined by the Existing Comparator LRTI Case Definition (Nokes et al.)|"LRTI is diagnosed when a child has a history of acute cough or difficulty in breathing and greater than or equal to (≥) 1 of the following: Fast breathing for age (≥ 60 breaths/minimum if the child is < 2 m ≥ 50 breaths/minimum if the child is 2-11 m). Indrawing, or Low oxygen saturation (< 90%) by pulse oxymetry or inability to feed (prostration or unconsciousness), when accompanied by a clinical diagnosis of LRTI or bronchiolitis.~Severe LRTI is diagnosed when a child has Indrawing, or Low oxygen saturation (< 90%) by pulse oxymetry or inability to feed (prostration or unconsciousness), when accompanied by a clinical diagnosis of LRTI or"|From birth up to 2 years of age|The analysis was performed on the RSV LRTI or severe LRTI episodes reported in the Per Protocol Set (PPS), which included all subjects enrolled in the primary cohort study meeting all eligibility criteria up to the time of their censoring, either at completion of epoch 1 or prematurely as drop-out (e.g. withdrawn consent, lost-to-follow-up).|||RSV-LRTI episodes|||Number
2615962|NCT01995175|Primary|Number of RSV LRTI or Severe LRTI Episodes as Defined by the Existing Comparator LRTI Case Definition (WHO [Modjarrad 2015])|"LRTI is diagnosed when a child <5 years presents with cough and/or difficulty in breathing has the following symptoms: Fast breathing, (>60 per minute in a child <2 m, >50 per minute in a child 2 to 11 m and >40 per minute in a child 12 to 59 m) or Oxygen saturation <95% by pulse oximetry.~Severe LRTI is diagnosed when a child has LRTI and Oxygen saturation <93% by pulse oximetry and/or lower chest chest wall in-drawing."|From birth up to 2 years of age|The analysis was performed on the RSV LRTI or severe LRTI episodes reported in the Per Protocol Set (PPS), which included all subjects enrolled in the primary cohort study meeting all eligibility criteria up to the time of their censoring, either at completion of epoch 1 or prematurely as drop-out (e.g. withdrawn consent, lost-to-follow-up).|||RSV-LRTI episodes|||Number
2615963|NCT01995175|Primary|Number of RSV LRTI or Severe LRTI Episodes as Defined by the GalxoSmithKline (GSK) LRTI Case Definition|"LRTI refers to Child with RTI AND Blood Oxygen Saturation (Sa O 2) lower than (<) 95 percent (%), OR respiratory rate (RR) increase: higher than (>) 60/m in < 2 months (m) of age; > 50/m in 2-11m of age, 40/m in 12-24m of age . LRTI Case definition by WHO : LRTI is diagnosed when a child <5 years presents with cough and/or difficulty in breathing has the following symptoms: Fast breathing, (>60 per minute in a child <2 m, >50 per minute in a child 2 to 11 m and >40 per minute in a child 12 to 59 m ) or Oxygen saturation <95% by pulse oximetry.~Severe LRTI: Child with LRTI AND SaO2 < 92%, OR Difficulty breathing leading to: Irritability/agitation, OR Lethargy/sleepiness, OR Severe chest indrawing, OR Reduced/no vocalization, OR Apnoea > 20 sec, OR Cyanosis, ORStop feeding well/dehydration"|From birth up to 2 years of age|The analysis was performed on the RSV LRTI or severe LRTI episodes reported in the Per Protocol Set (PPS), which included all subjects enrolled in the primary cohort study meeting all eligibility criteria up to the time of their censoring, either at completion of epoch 1 or prematurely as drop-out (e.g. withdrawn consent, lost-to-follow-up).|||RSV-LRTI episodes|||Number
2615964|NCT01995175|Primary|Number of Subjects With RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI as Defined by the LRTI Case Definition and Severity Scale|LRTI Case definition by WHO (Modjarrad 2015): LRTI is diagnosed when a child <5 years presents with cough and/or difficulty in breathing has the following symptoms: Fast breathing, (>60 per minute in a child <2 m, >50 per minute in a child 2 to 11 m and >40 per minute in a child 12 to 59 m) or Oxygen saturation <95% by pulse oximetry.|From birth up to 2 years of age|The analysis was performed on the Per Protocol Set (PPS) which included all subjects enrolled in the primary cohort study meeting all eligibility criteria up to the time of their censoring, either at completion of epoch 1 or prematurely as drop-out (e.g. withdrawn consent, lost-to-follow-up).|||Participants|||Count of Participants
2615965|NCT01995175|Primary|Number of Subjects Hospitalized for RSV|"Healthcare utilization included primary, secondary and tertiary care settings such as self-care with Over-The-Counter [OTC] drugs, general practitioner [GP] visits, emergency room [ER] visits, hospital visits, etc.~Note: This outcome measure presents results only for the RSV hospitalization. Results for other causes (non-RSV) hospitalization and healthcare utilization for other settings were not calculated, as data were not available."|From birth up to 2 years of age|The analysis was performed on the Per Protocol Set (PPS) which included all subjects enrolled in the primary cohort study meeting all eligibility criteria up to the time of their censoring, either at completion of epoch 1 or prematurely as drop-out (e.g. withdrawn consent, lost-to-follow-up).|||Participants|||Count of Participants
2615966|NCT01995175|Primary|Number of Subjects With Confirmed Respiratory Syncytial Virus (RSV)|Detection of the RSV-infection was performed by reverse transcription quantitative real time polymerase chain reaction (RT-qPCR ) assay on ribonucleic acids (RNA) extracted from nasal swabs.|From birth up to 2 years of age|The analysis was performed on the Per Protocol Set (PPS) which included all subjects enrolled in the primary cohort study meeting all eligibility criteria up to the time of their censoring, either at completion of epoch 1 or prematurely as drop-out (e.g. withdrawn consent, lost-to-follow-up).|||Participants|||Count of Participants
2615967|NCT01995136|Primary|Mean Change From Baseline in IOP (9:00 AM) at Week 4, Week 8, and Week 12|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data at 9:00 AM from Weeks 4, 8, and 12 were pooled. A more negative change indicates a greater amount of improvement. One eye (study eye) was subject to analysis.|Baseline (Day 0), Week 4, Week 8, Week 12|This analysis population includes all enrolled subjects minus any subjects with all missing data and/or critical protocol deviation/s.|||mmHg||95% Confidence Interval|Least Squares Mean
2615968|NCT01995123|Secondary|Clinician Administered PTSD Scale Score|PTSD symptoms as assessed via the Clinician-Administered PTSD Scale (CAPS). Minimum score = 0, maximum score = 80. Higher scores indicate greater severity of symptoms.|4 weeks post target quit date (end of treatment)|Outcome Measure assessed at separate study visit. Data reported for participants who were assessed at this visit.|||Units on a scale||Standard Deviation|Mean
2615969|NCT01995123|Secondary|Time to Smoking Relapse|Days to first relapse after the target quit date|26 weeks post target quit date||||Days||Standard Deviation|Mean
2615970|NCT01995123|Primary|Percentage of Participants Who Abstained From Smoking|7-day point prevalence abstinence at weeks 4, 12, 20, and 26 post target quit day|26 weeks post target quit date||||Participants|||Count of Participants
2615971|NCT01995071|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants completing combination treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of combination study drug|Combination Treatment Analysis Set: all participants who receive at least 1 dose of the combination regimen of ABT-450/r/ABT-267 + ABT-333 + RBV, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
2615972|NCT01995071|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during combination treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during combination treatment; or HCV RNA ≥ LLOQ at end of combination treatment with at least 6 weeks of combination treatment.|Up to 87 days|Combination Treatment Analysis Set: all participants who receive at least 1 dose of the combination regimen of ABT-450/r/ABT-267 + ABT-333 + RBV.|||participants||95% Confidence Interval|Number
2615973|NCT01995071|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of combination study drug.|12 weeks after last actual dose of combination study drug|Combination Treatment Analysis Set: all participants who receive at least 1 dose of the combination regimen of ABT-450/r/ABT-267 + ABT-333 + RBV; participants with missing data after backwards imputation were counted as nonresponders.|||percentage of participants|||Number
2616059|NCT01994486|Secondary|Proportion of Subjects Who Achieve Undetectable Hepatitis C Virus RNA at 12 Weeks After Completing Study Drug Regimen|Plasma HCV RNA levels were assessed using the COBAS TaqMan HCV RNA assay test (v2.0; Roche Diagnostics, Indianapolis, IN, USA; LLOQ=25 IU/mL;limit of detection =15 IU/mL)|6/16/2014-7/2/2014||||participants|||Number
2615974|NCT01995071|Primary|Maximal Decrease From Baseline in log10 HCV RNA Levels During ABT-493 or ABT-530 Monotherapy Treatment|Maximal decrease from baseline in log10 HCV RNA levels during ABT-493 or ABT-530 monotherapy treatment. The baseline value was the last measurement before the first dose of monotherapy on Day 1.|Day 1 through prior to first dose of the combination regimen on Study Day 4|Monotherapy Analysis Sets for Substudy 1 (Arms 1-5, 11) and SubStudy 2 (Arms 6-10, 12) are defined as all participants who received at least 1 dose of monotherapy and have a baseline and at least 1 postbaseline measurement of HCV RNA during monotherapy. Data for subjects who received the same treatment (Arms 4+5; Arms 7+10) were analyzed together.|||Log10 IU/mL||Standard Deviation|Mean
2615975|NCT01995045|Secondary|Mean Oxycodone Intake|The mean oxycodone use post surgery in milligrams(mg).|Post Surgery (Up to 24 hours)||||milligrams||Standard Deviation|Mean
2615976|NCT01995045|Secondary|Mean Hydrocodone Intake|The mean hydrocodone use post surgery in milligrams(mg).|Post Surgery (Up to 24 hours)||||milligrams||Standard Deviation|Mean
2615977|NCT01995045|Secondary|Mean Acetaminophen Intake|The mean acetaminophen use post surgery in milligrams(mg).|Post Surgery (Up to 24 hours)||||milligrams||Standard Deviation|Mean
2615978|NCT01995045|Primary|Mean Pain Score|The mean pain score assessed by the Visual Analog Pain Scale ranging from 0-10; 10 being the worst possible pain.|Post-Operative Day 1 (Up to 24 hours)||||units on a scale||Standard Deviation|Mean
2615979|NCT01994993|Other Pre-specified|Number of Participants With Positive Blood Cultures|Positive blood culture (bacterial or fungal)|90 days after last dose of study drug|Participant who received at least 1 dose of each study drug|||Participants|||Count of Participants
2615980|NCT01994993|Other Pre-specified|Number of Participants With Seizure|documented seizure(s) in hospital records|90 days after last dose of study drug|Participant who received at least 1 dose of each study drug|||Participants|||Count of Participants
2615981|NCT01994993|Other Pre-specified|Number of Participants With Gastrointestinal Surgeries|Determined by medical history and confirmed with hospital records. (Laparotomy)|90 days after last dose of study drug|Participant who received at least 1 dose of each study drug|||Participants|||Count of Participants
2615982|NCT01994993|Other Pre-specified|Number of Participants Progressed to a Higher Stage of Necrotizing Enterocolitis (NEC), if NEC is the Cause of the Complicated Intra-abdominal Infection|Progression is determined by the clinical NEC scoring|90 days after last dose of study drug|Participant who received at least 1 dose of each study drug|||Participants|||Count of Participants
2615983|NCT01994993|Other Pre-specified|Number of Participants With Intestinal Stricture|"Intestinal stricture: Radiology reports leading to the diagnosis of intestinal stricture. These include plain abdominal x-rays, upper gastrointestinal series with small bowel follow-through, contrast enema studies, and computed tomography scans of the abdomen and pelvis.~Operative reports documenting surgical procedures leading to the diagnosis and/or treatment of intestinal stricture. These procedures include endoscopy, laparotomy, stricture dilatation, intestinal resection, and ostomy placement"|90 days after last dose of study drug|Participant who received at least 1 dose of each study drug|||Participants|||Count of Participants
2615984|NCT01994993|Other Pre-specified|Number of Participants With Intestinal Perforation|"Intestinal perforation: Radiological reports leading to the diagnosis of intestinal perforation. These include plain chest x-rays, plain abdominal x-rays, ultra-sonograms of the abdomen, contrast studies, and computed tomography scans of the abdomen and pelvis.~Operative reports documenting surgical procedures leading to the diagnosis and/or treatment of intestinal perforation. These include placement of a surgical drain, laparotomy, intestinal resection, and ostomy placement"|90 days after last dose of study drug|Participant who received at least 1 dose of each study drug|||Participants|||Count of Participants
2615985|NCT01994993|Other Pre-specified|Number of Participants With Short Bowel Syndrome|"Short bowel syndrome: Operative reports documenting resection of bowel, estimated bowel length, and absence/presence of the ileocecal valve.~Total parenteral nutrition for >42 consecutive days after bowel resection, or a residual small bowel length of less than 25% expected for gestational age"|90 days after last dose of study drug|Participant who received at least 1 dose of each study drug|||Participants|||Count of Participants
2615986|NCT01994993|Other Pre-specified|Number of Participants With Grade 3 and/or Grade 4 Intraventricular Hemorrhage (IVH)|"Grade 3 IVH: Subependymal hemorrhage with extension into lateral ventricles with ventricular enlargement~Grade 4 IVH: Intraparenchymal hemorrhage"|90 days after last dose of study drug|Participant who received at least 1 dose of each study drug|||Participants|||Count of Participants
2615987|NCT01994993|Other Pre-specified|Number of Participants With Feeding Intolerance|Feeding intolerance confirmed by documentation of any feedings held for >24 consecutive hours in infants being fed|90 days after last dose of study drug|Participant who received at least 1 dose of each study drug|||Participants|||Count of Participants
2615988|NCT01994993|Secondary|Number of Participants With Therapeutic Success at Day 30|"Confirmed by 1).Alive, 2).Negative bacterial blood cultures, and 3). Clinical cure score >4.~Clinical cure score =1 for each of the following elements:~FiO2 ≤ baseline FiO2; Urine output ≥1 mL/kg/h for 24-hour period prior to assessment; Absence of inotropic support at time of assessment; Absence of mechanical ventilation at time of assessment; No seizure in 24-hour period prior to assessment; pH ≥7.25 or not measured in 24 hours prior to assessment"|30 days after last dose of study drug|Participants who received at least 1 dose of each study drug. Does not apply to Group 5.|||Participants|||Count of Participants
2615989|NCT01994993|Primary|Death|Number of Participants who experienced Death|Within 30 days after last dose of study drug, up to 40 days|Full intent-to-treat population (patients who received at least 1 dose of any study drug)|||Participants|||Count of Participants
2615999|NCT01994889|Secondary|Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT) at Month 30|6MWT is the total distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline, Month 30|Analysis performed on ITT analysis set. The pre-specified intent of this study was to compare the results between tafamidis with placebo, irrespective of the tafamidis doses. This analysis was based on the pooled dose groups, as per the study protocol. Here, ‘number analyzed’ = participants evaluable for this outcome at specified time points.|||meters||Standard Deviation|Mean
2617049|NCT01984424|Secondary|Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 22 and 24||Baseline and weeks 22 and 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
2615990|NCT01994954|Secondary|Growth Parameters, Weight-for-length Z-score Change|Growth measurements were taken at each monthly clinic visit while on oxygen. The average for weight for length z-score change was calculated for each subject while on oxygen therapy. After oxygen discontinuation, growth measurements were taken at the 1 month and 6 month post wean visits. These two measurements were again averaged for each patient. The weight for length z-score change was found in both arms for pre and post weaning from home oxygen therapy.The weight-for-length z-score indicates the number of standard deviations away from the mean a participants weight is. A z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|Enrollment through 6 months post discontinuation of home oxygen therapy|We had data for 87 and 72 infants in the standard of care arm and RHO arm, respectively, during the O2 weaning process, and 80 and 73 infants after O2 discontinuation.|||Weight-for-Length z-score change||Standard Error|Mean
2615991|NCT01994954|Secondary|Growth Parameters|Growth measurements were taken at each monthly clinic visit while on oxygen. The average for weight z-score change was calculated for each subject while on oxygen therapy. After oxygen discontinuation, growth measurements were taken at the 1 month and 6 month post wean visits. These two measurements were again averaged for each patient. The weight z-score change was found in both arms for pre and post weaning from home oxygen therapy. The weight z-score indicates the number of standard deviations away from the mean a participants weight is. A z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|Enrollment to 6 months post home oxygen therapy discontinuation|We had data for 87 and 72 infants in the standard of care arm and RHO arm, respectively, during the O2 weaning process, and 80 and 73 infants after O2 discontinuation.|||Weight z-score change||Standard Deviation|Mean
2615992|NCT01994954|Secondary|Participants With Respiratory-related Emergency Department Visits and Rehospitalizations|We will assess rates of rehospitalization or ED visit throughout the weaning process and continue to assess until 6 months post discontinuation.|WIthin 6 months of discontinuation of home oxygen||||participants|||Number
2615993|NCT01994954|Primary|Caregiver Quality of Life|We will compare the difference between survey-derived quality-of-life scores, comparing parent response averages while on home oxygen therapy (HOT) versus 3 months post oxygen discontinuation scores in both arms. The infant scale is composed of 36 items comprising 5 dimensions. The item scaling is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores range from 0 to 100, with a higher score indicating a higher parent satisfaction and quality of life.|Monthly while on home oxygen therapy and at 3 months post discontinuation of therapy|The final cohort included 196 infants, of those infants 105 parents completed at least one pre-parent satisfactory survey and one post-survey.|||score on a scale||Standard Deviation|Mean
2615994|NCT01994954|Primary|Duration of Home Oxygen Therapy|Duration of home oxygen use from time of randomization (baseline visit) to successful discontinuation of home oxygen therapy (HOT).|NICU discharge date until successful discontinuation of home oxygen therapy (HOT), up to 26 months.|A total of 166 infants were weaned successfully from HOT using one of our two methods, and a total of 140 subjects completed all study procedures through six months of follow-up post discontinuation of HOT. A total of 30 subjects were not weaned using either method due to being lost to follow-up, withdrawing, or parents self-weaning subject.|||Days||90% Confidence Interval|Median
2615995|NCT01994902|Primary|Degree of Leakage|The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).|28 +/- 3 days|The results presented above are the intention-to-treat results that were analysed as randomised. However, the adverse events are reported as treated and as 4 subjects did not follow the randomisation order there is a slight discrepancy between the participants number in the outcome and adverse events section.|||units on a scale|Participants|Standard Deviation|Mean
2615996|NCT01994889|Secondary|Percentage of Participants With Stabilized Transthyretin (TTR) at Month 1|TTR stabilization is a measure of the degree of stabilization afforded the TTR molecule by tafamidis.|Month 1|Analysis performed on ITT analysis set. The pre-specified intent of this study was to compare the results between tafamidis with placebo, irrespective of the tafamidis doses. This analysis was based on the pooled dose groups, as per the study protocol. Here, ‘number of participants analyzed’ = participants evaluable for this outcome.|||percentage of participants|||Number
2615997|NCT01994889|Secondary|Number of Participants With Cardiovascular-Related Mortality|Deaths adjudicated as CV-related and indeterminate are reported. Participants who discontinued for transplantation (heart transplantation and combined heart and liver transplantation) or for implantation of a cardiac mechanical assist device, were handled in the same manner as death.|Baseline up to Month 30|ITT analysis set: all participants in the safety population who had at least 1 post baseline efficacy evaluation. The pre-specified intent of this study was to compare the results between tafamidis with placebo, irrespective of the tafamidis doses. Therefore, this analysis was based on the pooled dose groups, as per the study protocol.|||Participants|||Count of Participants
2615998|NCT01994889|Secondary|Change From Baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS) at Month 30|KCCQ is a 23-item participant-completed questionnaire that assesses health status and health-related quality of life in participants with heart failure. Eight domain scores were calculated for the KCCQ: Physical limitation, Social limitation, Quality of life, Self-efficacy, Symptom stability, Symptom frequency, Symptom burden, and Total symptoms (calculated as the mean of Symptom frequency and Symptom burden scores). Two summary scores were also calculated: Clinical Summary (calculated as mean of Physical limitation and Total symptom scores) and Overall Summary (calculated as mean of Physical limitation, Social limitation, Total symptoms, and Quality of life scores). Domain and summary scores were scaled to range from 0 (minimum) to 100 (maximum); higher scores represent better health status.|Baseline, Month 30|Analysis performed on ITT analysis set. The pre-specified intent of this study was to compare the results between tafamidis with placebo, irrespective of the tafamidis doses. This analysis was based on the pooled dose groups, as per the study protocol. Here, ‘number analyzed’ = participants evaluable for this outcome at specified time points.|||units on a scale||Standard Deviation|Mean
2616060|NCT01994486|Other Pre-specified|Number of Subjects With Sustained Virologic Response at 4 Weeks After Completion of Last Dose|Subjects who complete assigned treatment and have undetectable HCV RNA at 12 weeks after the last planned dose of study treatment|4/22/2014-5/6/2014||||participants|||Number
2616000|NCT01994889|Secondary|Frequency of Cardiovascular-Related Hospitalizations|CV related hospitalizations per year is calculated as participant's number of CV related hospitalizations upon duration on study in years.|Baseline to Month 30|ITT analysis set: all participants in the safety population who had at least 1 post baseline efficacy evaluation. The pre-specified intent of this study was to compare the results between tafamidis with placebo, irrespective of the tafamidis doses. Therefore, this analysis was based on the pooled dose groups, as per the study protocol.|||CV hospitalization per year||Standard Deviation|Mean
2616001|NCT01994889|Secondary|All-Cause Mortality|Number of deaths due to any cause was analyzed. Participants who discontinued for transplantation (heart transplantation and combined heart and liver transplantation) or for implantation of a cardiac mechanical assist device were handled in the same manner as death.|Baseline up to Month 30|ITT analysis set: all participants in the safety population who had at least 1 post baseline efficacy evaluation. The pre-specified intent of this study was to compare the results between tafamidis with placebo, irrespective of the tafamidis doses. Therefore, this analysis was based on the pooled dose groups, as per the study protocol.|||Participants|||Count of Participants
2616002|NCT01994889|Primary|Hierarchical Combination of All-Cause Mortality and Frequency of Cardiovascular-Related Hospitalizations|"All-cause mortality and frequency of cardiovascular hospitalization were analyzed using Finkelstein-Schoenfeld method. The method combines all-cause mortality and frequency of CV-related hospitalizations in a hierarchical fashion using all-cause mortality first. The method compares every participant with every other participant within strata, assigning a +1 to the better participant and a -1 to the worse participant and 0 if they are tied. Participants who discontinued for transplantation (heart transplantation and combined heart and liver transplantation) or for implantation of a cardiac mechanical assist device, were handled in the same manner as death. 'Win' represents a participant doing better based on hierarchical comparison. The reported unit is the total wins for each treatment group from performing such a hierarchical comparison across all 4 strata in the study."|Baseline up to Month 30|ITT analysis set:participants in safety population(randomized participants who received at least 1 dose of double-blind medication)having at least 1 post baseline efficacy.Pre-specified intent of study was to compare results between tafamidis with placebo,irrespective of tafamidis doses. Analysis based on pooled dose groups,as per study protocol.|||wins|||Number
2616003|NCT01994876|Primary|Degree of Leakage|The degree of leakage was measured with a 32-point scale developed by Coloplast A/S, where 0 point represents the best possible outcome (no leakage) and 32 represents the worst possible outcome (full leakage under baseplate)|14 days||||units on a scale|Participants|Standard Deviation|Mean
2616004|NCT01994863|Primary|Leakage|The percentage of baseplates with no leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.|14+/-3 days per product|Intention-to-treat population|||percentage of baseplates with no leakage|Participants||Number
2616005|NCT01994850|Primary|Overall Response Rate (ORR)|Overall response rate (ORR) is defined as the proportion of patients with CR or PR according to the International Working Group Response Criteria for non-Hodgkin Lymphoma at the conclusion of systemic therapy.|Three to five weeks after the completion of Cycle 6 (approximately 5 months after start if treatment)|32 patients were enrolled: 1 patient withdrew, 1 was removed for protocol non-compliance, 1 was removed due to regimen violation; a total of 29 were evaluable for efficacy.|||Participants|||Count of Participants
2616006|NCT01994850|Primary|Number of Subjects With Dose-limiting Toxicities|Dose-limiting toxicity (DLT) is any grade 3 or 4 new non-hematologic toxicity occurring during Cycle 1 requiring a dose delay of >14 days from the planned Day 1 of Cycle 2 (21 days from Day 1 of Cycle 1). The initial planned dose of brentuximab vedotin for the Phase I cohort of 6 patients is 1.8 mg/kg. This cohort will be evaluated for DLT in the first cycle of treatment. Dose de-escalation to 1.2 mg/kg will occur if ≥ 2 of 6 patients at the 1.8 mg/kg dose level experience a DLT.|21 days (Cycle 1)|A total of 6 subjects were evaluated for dose limiting toxicities during Phase I. Since no DLTs were observed, the Phase I subjects were included in the efficacy analysis as they received the same dose of brentuximab vedotin 1.8 mg/kg as the Phase II subjects.|||Participants|||Count of Participants
2616007|NCT01994837|Secondary|Complete Remission Rate and Complete Remission With Incomplete Marrow Recovery (CRi) Rate|The complete remission rate and the complete remission with incomplete marrow recovery rate (Cri) was defined as the percentage of participants who achieved complete remission (CR) or complete remission with incomplete bone marrow recovery (CRi), per the International Working Group criteria for AML. Complete remission (CR) was defined as peripheral neutrophils at least 10˄3/μL, platelets ≥ 10˄5/μL and normocellular bone marrow with ≤ 5% blasts. Complete remission with incomplete bone marrow recovery (CRi) was defined as bone marrow with less than 5% blasts, with peripheral neutrophils of at least 10˄3/μL or platelets ≥ 10˄5/μL.|When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier|All participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2616008|NCT01994837|Secondary|Complete Remission With Incomplete Marrow Recovery (CRi) Rate|The complete remission with incomplete bone marrow recovery (CRi) rate was defined as the percentage of participants who achieved CRi per the International Working Group criteria for AML. Complete remission with incomplete bone marrow recovery was defined as bone marrow with less than 5% blasts, with peripheral neutrophils of at least 10˄3/μL or platelets ≥ 10˄5/μL.|When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier|All participants who received at least 1 dose of study drug|||percentage of participants|||Number
2616009|NCT01994837|Secondary|Rate of Minimal Residual Disease (MRD) Negativity|The rate of minimal residual disease (MRD) response was defined as the percentage of participants who had MRD negative status. Only participants with a reported MRD assessment (negative or positive) from the local laboratory at the investigator site were used in the calculation of MRD response rate.|When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier|Participants with available data|||percentage of participants||95% Confidence Interval|Number
2616061|NCT01994486|Secondary|Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007|Sparse Pharmokinetic blood samples were collected at Week 2 and Week 10 (prior to daily dose) in patients treated with Telaprevir and Sofosbuvir.|1/17/2014-3/26/2014||||ng/mL||Standard Deviation|Geometric Mean
2616011|NCT01994837|Secondary|Overall Survival|Overall survival was defined as the number of months from the date of enrollment to the date of death for all dosed participants. For participants who did not die, their data were censored at the date of last study visit or the last known date to be alive, whichever was later.|Measured up to 2 years after the last subject had enrolled in the study.|All participants who received at least 1 dose of study drug|||months||95% Confidence Interval|Median
2616012|NCT01994837|Secondary|Progression-free Survival|Progression-free survival was defined as the number of months from the date of enrollment to the date of earliest progression or death. If a participant did not experience disease progression or death, then the data was censored at the date of the last disease assessment.|When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier|All participants who received at least 1 dose of study drug|||months||95% Confidence Interval|Median
2616013|NCT01994837|Secondary|Time to Progression|Time to progression was defined as the number of months from the date of enrollment to the date of earliest disease progression. If a participant did not experience disease progression, then the data for that participant was censored at the date of the last disease assessment.|When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier|All participants who received at least 1 dose of study drug|||months||95% Confidence Interval|Median
2616014|NCT01994837|Secondary|Duration of Remission|Duration of remission was defined as the number of days from the date of first remission (CR, CRi, or PR) per the International Working Group criteria for AML to the earliest recurrence or progressive disease (PD). In this study, the duration of remission analysis was not performed because of the low remission rate, per the Statistical Analysis Plan.|When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier|The duration of remission analysis was not performed because of the low remission rate, per the Statistical Analysis Plan.||||||
2616015|NCT01994837|Secondary|Complete Remission Rate|The complete remission (CR) rate was defined as the percentage of participants who achieved CR per the International Working Group criteria for AML. Complete remission was defined as peripheral neutrophils at least 10˄3/μL, platelets ≥ 10˄5/μL and normocellular bone marrow with ≤ 5% blasts.|When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier|All participants who received at least 1 dose of study drug|||percentage of participants|||Number
2616016|NCT01994837|Primary|Objective Remission Rate|The objective remission rate (ORR) was defined as the percentage of participants who achieved complete remission (CR), complete remission with incomplete bone marrow recovery (CRi), or partial remission (PR) per the International Working Group criteria for AML. Complete remission (CR) was defined as peripheral neutrophils at least 10˄3/μL, platelets ≥ 10˄5/μL and normocellular bone marrow with ≤ 5% blasts. Complete remission with incomplete bone marrow recovery (CRi) was defined as bone marrow with less than 5% blasts, with peripheral neutrophils of at least 10˄3/μL or platelets ≥ 10˄5/μL. Partial remission (PR) was defined as normalization in peripheral blood neutrophil and platelet counts with at least a 50% decrease in blasts persisting in bone marrow versus baseline.|When 19 participants had completed at least 12 weeks of treatment or after all enrolled participants had discontinued venetoclax, whichever was earlier|All participants who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2616017|NCT01994785|Primary|Number of Participants Experiencing Hypoxia During Capnography Monitoring.||One day--data is collected during one endoscopic procedure.||||Participants|||Count of Participants
2616018|NCT01994746|Secondary|Time to Maximum Change From Baseline Concentration (Tmax) of Glucose||Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visits with available pharmacodynamics (PD) data. Study dosing visits occurred on Day 0 and then again after the washout period between Day 7 to Day 28.|||hours||Full Range|Median
2616019|NCT01994746|Secondary|Maximum Change From Baseline Concentration (Cmax) of Glucose||Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visits with available pharmacodynamics (PD) data. Study dosing visits occurred on Day 0 and then again after the washout period between Day 7 to Day 28.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2616020|NCT01994746|Secondary|Area Under the Effect Concentration Time Curve (AUEC0-1.5) of Baseline-Adjusted Glucose From Time Zero up to 90 Minutes||Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visits with available pharmacodynamics (PD) data. Study dosing visits occurred on Day 0 and then again after the washout period between Day 7 to Day 28.|||hr*mg/dL||Standard Deviation|Mean
2616021|NCT01994746|Secondary|Time to Maximum Change From Baseline Concentration (Tmax) of Glucagon||Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visits with available pharmacokinetics (PK) data. Study dosing visits occurred on Day 0 and then again after the washout period between Day 7 to Day 28.|||hours||Full Range|Median
2616022|NCT01994746|Secondary|Maximum Change From Baseline Concentration (Cmax) of Glucagon||Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visits with available pharmacokinetics (PK) data. Study dosing visits occurred on Day 0 and then again after the washout period between Day 7 to Day 28.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
2616023|NCT01994746|Secondary|Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of Baseline-Adjusted Glucagon||Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60 and 90 minutes following glucagon administration|All enrolled participants that completed the required dosing visits with available pharmacokinetics (PK) data. Study dosing visits occurred on Day 0 and then again after the washout period between Day 7 to Day 28.|||hour*picograms per milliliter (hr*pg/mL)||Standard Deviation|Mean
2616107|NCT01993875|Primary|Number of Spontaneous Bowel Movements (SBMs) Within 1 Week|SBM is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.|within 1 week|Modified Intention to Treat (mITT), defined as all participants who received at least 1 dose of study medication.|||number of SBMs||Standard Deviation|Mean
2616024|NCT01994746|Secondary|Time From Glucagon Administration to Blood Glucose >/=70 mg/dL or an Increase ≥20 mg/dL in Blood Glucose From Nadir|The mean time from glucagon administration to blood glucose >/=70 mg/dL or an increase ≥20 mg/dL in blood glucose from nadir.|Pre-dose; 5, 10, 15, 20, 25, and 30 minutes following glucagon administration|All enrolled participants that completed the required dosing visits with eligible glucose and glucagon levels. Study dosing visits occur on Day 0 and then again after the washout period between Day 7 to Day 28.|||minutes|||Number
2616025|NCT01994746|Secondary|Recovery From Symptoms of Hypoglycemia|Recovery from hypoglycemia symptoms were assessed using the Edinburgh Hypoglycemia Scale. The Edinburgh Hypoglycemia Symptom Scale measures the intensity of 15 commonly experienced hypoglycemic symptoms on a 7-point Likert scale (1 = not present, 7 = very intense). The higher the score, the more intense the hypoglycemia symptoms. The sum of each symptom score would yield a range of 15 to 105 (i.e., 15 x 7 =105). The total score was calculated as the sum of each symptom score minus 15, and summarized at each time point by treatment group.|Pre-dose;15, 30, 45 and 60 minutes following administration of glucagon|All enrolled participants who completed at least one post administration survey.|||units on a scale||Standard Deviation|Mean
2616026|NCT01994746|Secondary|Nasal and Non-nasal Effects/Symptoms|"Symptoms of runny nose, nasal congestion and/or itching, sneezing, watery and/or itchy eyes, redness of eyes, and itching of ears and/or throat were assessed. This was done via the Nasal Non-nasal Score Questionnaire. Each of the 9 symptoms is assigned an integer value from 0 to 3; higher values indicate more severe symptoms (a score of 0 indicates no symptoms). The reported results indicate the cohort median out of a possible maximum value of 27 (summing all 9 questions for each subject and reporting the median/IQR across participants)."|Pre-dose; 15, 30, 60, and 90 post glucagon administration|All enrolled T1D participants that completed the required dosing visits. Study dosing visits occur on Day 0 and then again after the washout period between Day 7 to Day 28.|||units on a scale||Inter-Quartile Range|Median
2616027|NCT01994746|Primary|Increase in Plasma Glucose Level to >=70mg/dL or an Increase of >=20mg/dL From Glucose Nadir|Increase in blood glucose to ≥70 mg/dL or an increase of ≥20 mg/dL from glucose nadir within 30 minutes after receiving study glucagon, without receiving additional actions to increase the blood glucose level defines treatment success. Due to the residual activity of circulating insulin, glucose nadir was defined as the minimum glucose measurement at the time of, or within 10 minutes following glucagon administration.|Within 30 minutes after receiving glucagon at both dosing visits (glucose was measured at pre-dose; 5, 10, 15, 20, 25, and 30 minutes following glucagon administration)|All enrolled participants who completed both eligible Study/Dosing Visits.|||percentage of participants|||Number
2616028|NCT01994720|Secondary|Number of Participants With Premature Discontinuation of Study Drug Due to Any Bleeding Adverse Event|Participants discontinuation of study drug due to any bleeding adverse event. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).|Time from first dose and up to and including 7 days following the date of last dose of the study|The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available.|||Participants|||Number
2616029|NCT01994720|Secondary|Number of Participants With PLATO Major Bleeding Event|"Participants with PLATO Major bleeding. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).~PLATO Major bleeding is defined as a bleed that is any one of:~Fatal~Intracranial (excluding asymptomatic haemorrhagic transformations of ischemic brain infarctions and excluding micro-hemorrhages <10 mm evident only on gradient-echo MRI)~Intrapericardial bleed with cardiac tamponade~Hypovolaemic shock or severe hypotension due to bleeding and requiring pressors or surgery~Significantly disabling (eg. intraocular with permanent vision loss)~Clinically overt or apparent bleeding associated with a decrease in Hb of more than 30 g/L (1.9 mmol/L; 0.465 mmol/L)~Transfusion of 2 or more units (whole blood or packed red blood cells [PRBCs]) for bleeding."|From randomization up to 97 days|The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or ASA and for whom post-dose data are available.|||Participants|||Number
2616030|NCT01994720|Secondary|EQ-5D (EuroQol Five Dimensions Questionnaire) at Premature Treatment Discontinuation Visit|"EQ-5D index score using the UK tariff.~EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.~The higher the index score the better the health state. In this study index scores ran from -0.59 to 1."|Premature treatment discontinuation visit(<15 days after last dose)|Include only results from patients who visit the site in-person. The Premature Treatment Discontinuation visit (PTDV) is only done for patients who prematurely and permanently stop study medication.|||Index score||Standard Deviation|Mean
2616031|NCT01994720|Secondary|EQ-5D (EuroQol Five Dimensions Questionnaire) at End of Treatment Visit|"EQ-5D index score using the UK tariff.~EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.~The higher the index score the better the health state. In this study index scores ran from -0.59 to 1."|End of treatment visit (Day 90+-7d)|Include only results from patients who visit the site in-person.|||Index score||Standard Deviation|Mean
2616046|NCT01994629|Secondary|Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Safety was assessed in terms of number of subjects (12 to 15 months old) reporting unsolicited AEs (day 1 to day 29), SAEs, medically attended AEs, AEs leading to premature study withdrawal (Day 1 to Day 180) after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine.|Day 1 to Day 29 or Day 1 to Day 180 post-vaccination|Analysis was done on unsolicited safety data set ie, all subjects in the exposed set who had post-vaccination unsolicited adverse event records.|||Subjects|||Number
2616032|NCT01994720|Secondary|EQ-5D at Visit 2 (Day 7+-2d)|"EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff.~EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.~The higher the index score the better the health state. In this study index scores ran from -0.59 to 1."|Visit 2 (Day 7+-2d)|Include only results from patients who visit the site in-person.|||Index score||Standard Deviation|Mean
2616033|NCT01994720|Secondary|EQ-5D at Visit 1 (Enrolment)|"EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff.~EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.~The higher the index score the better the health state. In this study index scores ran from -0.59 to 1."|Visit 1 (Enrolment)|Include only results from patients who visit the site in-person.|||Index score||Standard Deviation|Mean
2616034|NCT01994720|Secondary|Change in NIHSS|"Change from baseline to end of treatment visit in NIHSS (National Institutes of Health Stroke Scale):~0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke."|From randomization up to 97 days|NIHSS in patients with an index stroke event|||Participants|||Number
2616035|NCT01994720|Secondary|Number of Participants With Disabling Stroke|Participants with disabling stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
2616036|NCT01994720|Secondary|Number of Participants With Fatal Stroke|Participants with fatal stroke. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
2616037|NCT01994720|Secondary|Number of Participants With Stroke|Participants with stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
2616038|NCT01994720|Secondary|Number of Participants by Severity of Stroke and Overall Disability|"Analysis of severity of stroke and overall disability of patients, using the modified Rankin Score, mRS.~Modified Rankin Score:~0 - No symptoms.~- No significant disability. Able to carry out all usual activities, despite some symptoms.~- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.~- Moderate disability. Requires some help, but able to walk unassisted.~- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.~- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.~- Dead.~Disability defined as mRS > 1.~Odds ratio and p-value are calculated for ticagrelor versus ASA from a logistic regression model with treatment group, history of stroke and NIHSS (National Institutes of Health Stroke Scale) at baseline as explanatory variables."|From randomization up to 97 days|The population was the full analysis set which included all randomized patients.|||Participants|||Number
2616039|NCT01994720|Secondary|Number of Participants With MI|Participants with MI. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
2616040|NCT01994720|Secondary|Number of Participants With CV Death|Participants with CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
2616041|NCT01994720|Secondary|Number of Participants With All-Cause Death|Participants with all-cause death. If no event, censoring at the minimum of (last date of event assessment, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
2616042|NCT01994720|Secondary|Number of Participants With Composite of Ischaemic Stroke, MI and CV Death|Participants with ischaemic stroke, MI or CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
2616043|NCT01994720|Secondary|Net Clinical Outcome|Participants with stroke, MI, death or life-threatening bleeding. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
2616044|NCT01994720|Secondary|Number of Participants With Ischaemic Stroke|Participants with ischaemic stroke. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
2616045|NCT01994720|Primary|Number of Participants With Composite of Stroke/MI/Death|Participants with stroke, MI or death. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).|From randomization up to 97 days|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
2616056|NCT01994590|Primary|Safety and Tolerability|Number of Participants with Adverse Events|Participants are followed while actively taking study drug and for at least 30 days post last dose.||||Participants|||Count of Participants
2616108|NCT01993849|Other Pre-specified|Measurement of Nail Length|Length of nails, measured by caliper|End of 8-week treatment||||millimeters||Standard Deviation|Mean
2616047|NCT01994629|Secondary|Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Safety was assessed in terms of number of subjects (12 to 15 months old) reporting any and each of solicited local and systemic AEs reported from Day 1 to 7 after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine.|Day 1 (6 hours) to Day 7 post-vaccination|Analysis was done on solicited safety data set. MedDRA version v.3.0 was used for the analyses (in the AEs section, MedDRA version v.17.01 was used, leading to a different terminology to describe some of the events reported in this outcome).|||Subjects|||Number
2616048|NCT01994629|Secondary|rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by rSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by rSBA GMTs on Day 180.|Day 1, Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.|||Titers||95% Confidence Interval|Geometric Mean
2616049|NCT01994629|Secondary|Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with four-fold increase in rSBA titer directed against N. meningitides serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by the percentages of subjects with four-fold increase in rSBA titer on Day 180 after vaccination.|Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.|||percentage of Subjects||95% Confidence Interval|Number
2616050|NCT01994629|Secondary|Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 128 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 128 on Day 180 after vaccination.|Day 1, Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.|||percentage of Subjects||95% Confidence Interval|Number
2616051|NCT01994629|Secondary|Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 8 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 8 on Day 180 after vaccination.|Day 1, Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.|||percentage of Subjects||95% Confidence Interval|Number
2616052|NCT01994629|Secondary|hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by hSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by hSBA GMTs at Day 180 after vaccination.|Day 1, Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.|||Titers||95% Confidence Interval|Geometric Mean
2616053|NCT01994629|Secondary|Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with seroresponse defined as for subjects with pre-vaccination hSBA titer < 4, post-vaccination hSBA titer ≥ 8; for subjects with pre-vaccination hSBA titer ≥ 4, an increase of at least four times the pre-vaccination hSBA directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence immune response was measured by the percentage of subjects with seroresponse at Day 180 after vaccination.|Day 29 and Day 180 post-vaccination|Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.|||percentage of Subjects||95% Confidence Interval|Number
2616054|NCT01994629|Secondary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.|Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with hSBA titer ≥ 8 directed against Neisseria meningitidis (N. meningitidis) serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by the percentages of subjects with hSBA titer ≥ 8 on Day 180 post-vaccination.|Day 1, Day 29 and Day 180 post-vaccination|Analysis was done on Full Analysis Set (FAS) Day 29 (subjects who received the vaccine and provided immunogenicity data at Day 29: MenACWY-CRM 95; MenACWT-TT 97). Persistence of immune responses at Day 180 was analysed on FAS Day 180 (subjects who received the vaccine and provided immunogenicity data at Day 180: MenACWY-CRM 98; MenACWT-TT 97).|||percentage of Subjects||95% Confidence Interval|Number
2616055|NCT01994629|Primary|Number of Subjects With at Least One Severe Solicited Adverse Event (AE) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT.|Reactogenicity of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by number of subjects with at least one severe solicited AE within 7 days after vaccination. Solicited AEs included tenderness, erythema, induration, irritability, sleepiness, change in eating habits, vomiting, diarrhea and fever.|Day 1 to Day 7 post-vaccination|Analysis was done on the solicited safety data set (all subjects in the exposed set who provided post vaccination reactogenicity data: MenACWY-CRM 99; MenACWY-TT 101).|||Number of Subjects|||Number
2616062|NCT01994486|Primary|Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir|Study drug adherence and adverse events were collected on all enrolled subjects and graded using the DAIDS scale. Any adverse events leading to discontinuation of both Telaprevir and Sofosbuvir were collected and are hereby reported.|12 weeks-January 3, 2014- April 10, 2014|Non-cirrhotic Hepatitis C Genotype 1 infected subjects, naive to previous Hepatitis C treatment|||participants|||Number
2616063|NCT01994395|Secondary|Berg Balance Scale (BBS)|The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance. The minimal detectable change score for individuals with acute stroke is 6.9 points16 and 4.66 points in chronic stroke17.|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.|||units on a scale, each item scored 0-4||Standard Deviation|Mean
2616064|NCT01994395|Secondary|Change in 6 Minute Walk Test From Baseline in Distance (6MWT)|"The 6 Minute Walk Test (6MWT) is a test of endurance, by measuring the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary.The distance is measured with a measuring wheel. The instructions are Walk covering as much ground as you can in 6 min. You can stop to sit or stand if needed, but time will keep running. The change in the distance walked in the 6-minute walk can be used to evaluate the efficacy of an exercise-training program or to trace the natural history of change in exercise capacity over time. The 6MWT is measured in meters."|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.|||units on a scale||Standard Deviation|Mean
2616065|NCT01994395|Secondary|Participants Receiving Transcranial Magnetic Stimulation (TMS)|To compare the effect of training on the connections between the brain and leg muscles (descending corticomotor drive) using a non-invasive brain stimulation called transcranial magnetic stimulation (TMS). TMS is a safe, non-invasive, painless method of brain stimulation that has been widely used to study the physiology of the representations of muscles in the motor cortex in healthy and neurologically disordered individuals13. Very short duration (< 1 ms) magnetic pulses are applied via an insulated wire coil placed on the intact scalp overlaying the motor cortical area projecting to a target muscle. Each pulse induces a motor evoked potential (MEP) in a target muscle that can be readily monitored by recording Electromyogram (EMG) from that muscle. A figure-of-eight or double cone coil is typically used to deliver focal magnetic pulses to a number of scalp sites over the cortical area representing a muscle of interest.|Session 0 (initial visit);Session 20 (between 6-8 weeks)|One subject dropped before being assigned to a group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.|||Participants|||Count of Participants
2616066|NCT01994395|Secondary|Patient Health Questionnaire-9 (PHQ-9)|PHQ-9 is a 9-item self-report questionnaire designed to diagnose both the presence of depressive symptoms as well as to characterize the severity of depression. A single question rates how difficult problems have made it to do work, take care of things at home or get along with other people using a 4 level scale (not difficult at all to extremely difficult). Each item is scored from 0-3; total scores may be 0-27, with higher scores representing increased severity of depression.|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.|||units on a scale||Standard Deviation|Mean
2616067|NCT01994395|Secondary|The Modified Falls Efficacy Scale (mFES)|14 item questionnaire assessing individuals' confidence in their ability to perform tasks without falling. Individuals rate their confidence from 0 (not confident at all) to 100 (completely confident).|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.|||units on a scale||Standard Deviation|Mean
2616068|NCT01994395|Secondary|Stroke Specific Quality of Life Scale (SS-QOL)|A 49 item assessment grouped into 12 domains of health-related quality of life in stroke survivors; including areas of mobility, energy, upper extremity function, work and productivity, mood, self-care, social roles, family roles, vision, language, thinking, personality. Each individual domain consists of 3 to 10 items that are averaged to generate an overall score, each item is rated on a 5- point Likert scale, with a minimum value of 1 (meaning the worst outcome) and a maximum value of 5 (meaning the best outcome). Domains scores (non-weighted average of item scores) and a summary score (non-weighted average of all 12 domain scores) are computed. Summary scores range from 49-245, with higher scores indicating better functioning.|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.|||units on a scale||Standard Deviation|Mean
2616069|NCT01994395|Secondary|Numeric Pain Rating Scale (NPRS)|The NPRS is an 11-point scale from 0-10 where patients verbally select a value that is most in line with the intensity of pain that they have experienced in the last 24 hours from 0 (no pain) to 10 (the most intense pain imaginable).|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject dropped out at baseline screening, prior to assignment to any group. One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.|||units on a scale||Standard Deviation|Mean
2616070|NCT01994395|Secondary|Activities-Specific Balance Confidence Scale (ABC)|ABC is a 16-item self-report measure in which patients rate their balance confidence in performing various ambulatory activities without falling. Items are rated on a scale ranging from 0-100, with zero representing no confidence and 100 representing complete confidence.|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.|||units on a scale||Standard Deviation|Mean
2616071|NCT01994395|Primary|Change in 10 Meter Walk Test From Baseline in Gait Speed|"Measure of self selected and fast walking speeds by measuring the time it takes an individual to walk 10 meters. The test is performed using a flying start, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: Please walk this distance at your normal pace when I say go. and repeated Please walk this distance as fast as you can safely when I say go."|Baseline Assessment (Visit 1), Mid Training Assessment (Visit 10), Post Training Assessment (Visit 18), 3 Month Post Training Assessment (3 Month Follow-up)|One subject from SMA group and 2 from impairment based therapy group dropped due to scheduling conflicts prior to starting any training.|||meters per second||Standard Deviation|Mean
2616072|NCT01994291|Other Pre-specified|Number of Participants With Change in Ophthalmoscopy Examination Results in Study Eye After Administration of Ranibizumab or Masked Sham Therapy at Week 8|Ophthalmoscopy ought to be performed after pupillary dilation to examine the vitreous body, optic nerve head, macular and peripheral retina. All findings, including the presence or absence of vitreous inflammation, ought to be documented. All post-dose ophthalmoscopy assessments ought to be made immediately following the administration of ranibizumab or masked sham therapy.|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.|||participants|||Number
2616073|NCT01994291|Other Pre-specified|Maximum Increase of Intraocular Pressure (IOP) From Baseline in Study Eye|IOP was measured using Goldmann applanation tonometry. To maintain consistency, it was recommended that the same examiner ought to measure IOP with the same tonometer at each visit for a given subject. Intraocular pressure ought to be measured in the study eye approximately 30 minutes after intravitreal injection or masked sham therapy (performed by unmasked study team member).|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.|||mmHg||Standard Deviation|Mean
2616074|NCT01994291|Other Pre-specified|Number of Participants With Changes in the Anterior Segment of the Study Eye at Week 12|The anterior biomicroscopy exam was done undilated in order to assess whether there was any anterior segment inflammation caused either by ranibizumab or PF-04634817.|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.|||participants|||Number
2616075|NCT01994291|Other Pre-specified|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (>=)300 milliseconds (msec) or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (≤)200 msec; QRS interval >=200 msec or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (≤)200 msec; QT interval >=500 msec; and QTcF >=450 msec or >=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.|||participants|||Number
2616076|NCT01994291|Other Pre-specified|Number of Participants With Laboratory Abnormalities|The following laboratory parameters were analyzed for abnormalities at any time point: hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count); blood chemistry (sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase); follicle-stimulating hormone (FSH) (Weeks -5 to 0 only, for postmenopausal women who have been amenorrheic for at least 12 consecutive months prior to screening visit).|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.|||participants|||Number
2616077|NCT01994291|Other Pre-specified|Number of Participants With Potentially Clinically Important Post-Baseline Vital Signs|Number of participants who met the categorical summary of post-baseline criteria at any time point, defined as: supine pulse rate <40 beats per minute (bpm) or >120 bpm; supine systolic blood pressure (SBP) ≥30 millimeters of mercury (mmHg) change from baseline in same posture; supine diastolic BP (DBP) ≥20 mmHg change from baseline in same posture; supine SBP <90 mmHg; supine DBP <50 mmHg.|Week -5 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.|||participants|||Number
2616078|NCT01994291|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Week 0 to Week 16|The Safety Analysis Set was defined as all subjects who receive at least 1 dose of study medication.|||participants|||Number
2616079|NCT01994291|Secondary|Plasma Concentration of PF-04634817 up to Week 12||Week 0, Week 4, Week 8, and Week 12|All subjects in the full analysis set (FAS) for whom a pharmacokinetic sample was obtained and analyzed. The FAS was defined as all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.|||nanogram (ng)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
2616109|NCT01993849|Primary|Number of Participants Enrolled Within One Year|Ability to enroll the goal sample within one year; we are interested in the feasibility of sufficient enrollment and data collection within a given period of time.|1 year|The goal sample was to enroll at least 10 participants per arm/group within the specified recruitment period.|||Participants|||Count of Participants
2616110|NCT01993823|Other Pre-specified|Mycological Study||Day 24|||||||
2616080|NCT01994291|Secondary|Mean Change From Baseline in Steps of Diabetic Retinopathy Step (ETDRS Severity Scale) in the Study Eye at Week 12|"Stereo color fundus photographs using certified digital systems were taken by a photographer who had been pre-certified (study certified) by the Central Reading Center. They were evaluated by the Central Reading Center."|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.|||Letters||80% Confidence Interval|Least Squares Mean
2616081|NCT01994291|Secondary|Mean Change From Baseline in The Area of Fluorescein Leakage in the Study Eye at Week 12|"Fluorescein Angiography (FA) using certified digital systems was taken by a photographer who had been pre-certified (study-certified) by the Central Reading Center. They were evaluated by the Central Reading Center."|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.|||mm^2||80% Confidence Interval|Least Squares Mean
2616082|NCT01994291|Secondary|Mean Change From Baseline in Central Subfield Retinal Thickness in the Study Eye at Week 12|"A central reading center was used for the evaluation. A photographer or technician pre certified (study certified) by the Central Reading Center ought to perform all optical coherence tomography (OCT) imaging. Use of a Spectralis or Cirrus OCT was acceptable."|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.|||microns||80% Confidence Interval|Least Squares Mean
2616083|NCT01994291|Secondary|Proportion of Subjects Gaining 15 ETDRS Letters in BCVA From Baseline at Week 12|Refraction and visual acuity were assessed through the BCVA obtained using the retro illuminated ETDRS charts. Distance visual acuity was expressed as an ETDRS score (number of letters correctly read).|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.|||proportion of participants|||Number
2616084|NCT01994291|Primary|Mean Letter Change From Baseline at Week 12 in Best Corrected Visual Acuity (BCVA)|Refraction and visual acuity were assessed through the BCVA obtained using the retro illuminated early treatment diabetic retinopathy study (ETDRS) charts. Distance visual acuity was expressed as an ETDRS score (number of letters correctly read).|Baseline (Day 0) and Week 12|all subjects randomized and who had received at least one dose of randomized treatment and had at least one post-baseline measurement of BCVA.|||Letters||80% Confidence Interval|Least Squares Mean
2616085|NCT01994226|Primary|Change in Pain Intensity|Worst pain intensity in last 24 hours using a 0 - 10 numeric rating scale, where high rates (10) indicate worst outcome|Days 0-7||||units on a scale||Standard Deviation|Mean
2616086|NCT01994109|Primary|Clinical Global Impression Change (CGI-C) at Week 4 Post-injection (Part A)|"CGI-C was assessed on a 7-point scale ranging from very much improved to very much worse with 1 assigned to very much improved and 7 assigned to very much worse; ranging from a minimum score of 1 and a maximum score of 7."|4 weeks|Per protocol the intent-to-treat population who were injected with study medication and had at least 1 post injection CGI-C measurement up to week 4 (inclusive).|||score on a scale||Standard Error|Least Squares Mean
2616087|NCT01994109|Primary|Unstimulated Salivary Flow Rate (USFR) at Week 4 Post-injection Visit (Part A)|Change weight of expectorated saliva at a Week 4 post-injection visit.|4 Weeks|The per protocol included subjects with a minimum USFR of 0.2 g/min.|||g/minute||Standard Error|Least Squares Mean
2616088|NCT01993940|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements With No Straining Per Week|A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. The severity of straining with each bowel movement was assessed on the following scale: 0=no straining, 1=mild straining, 2=moderate straining, 3=severe straining, 4=very severe straining. SBMs without straining were defined as SBMs with a straining score of 0.|Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)|Intent-to-treat population|||SBMs with no straining / week||Standard Error|Least Squares Mean
2616089|NCT01993940|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Spontaneous Bowel Movements Per Week|A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. A complete spontaneous bowel movement (CSBM) was defined as an SBM which was accompanied by the feeling of complete evacuation.|Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)|Intent-to-treat population|||complete spontaneous BMs / week||Standard Error|Least Squares Mean
2616090|NCT01993940|Secondary|Change From Baseline to Week 1 in the Number of Spontaneous Bowel Movements Per Week|A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of a rescue laxative therapy during the 24 hours prior to the BM. Baseline was defined as the 14 days in the screening period prior to study drug administration.|Baseline and Week 1|Intent-to-treat population|||spontaneous bowel movements / week||Standard Error|Least Squares Mean
2616091|NCT01993940|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week|A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of a rescue laxative therapy during the 24 hours prior to the BM. Baseline was defined as the 14 days in the screening period prior to study drug administration.|Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)|Intent-to-treat population|||spontaneous bowel movements / week||Standard Error|Least Squares Mean
2616106|NCT01993875|Secondary|Consistency of SBMs at Week 1|Stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid.|at Week 1|mITT Population|||score on a scale||Standard Deviation|Mean
2616092|NCT01993940|Primary|Percentage of Participants With a Spontaneous Bowel Movement (SBM) Response|"A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of rescue laxative therapy during the 24 hours prior to the BM.~A responder was defined as a participant having 9 or more positive response weeks out of the 12-week Treatment Period and 3 positive response weeks out of last 4 weeks of the 12-week Treatment Period. A positive response week was defined as ≥ 3 SBMs per week and an increase from baseline of ≥ 1 SBM per week for that week. If a participant had less than 4 days of diary entries for a week, that week was treated as a non-response week.~Any participant with insufficient primary endpoint data (data for less than 9 out of the 12 weeks of the Treatment Period or less than 3 out of the last 4 weeks of the 12-week Treatment Period) was treated as a non-responder"|12-week treatment period|Intent-to-treat population|||percentage of participants||95% Confidence Interval|Number
2616093|NCT01993927|Secondary|Percentage of Participants With Normalization of Impaired Glucose Tolerance (IGT) During Treatment Period|Percentage of participants who had normalization of Impaired Glucose Tolerance (IGT) during treatment period was reported. IGT normalization was determined by the survey physician based on the results of the 75-g oral glucose tolerance test (OGTT), glucose metabolism markers, and other data.|Up to Week 72|Safety/Efficacy Analysis Set was defined as all participants who were enrolled and completed the study. Reported data was collected from received case report forms including the data, without major protocol violations.|||Percentage of participants|||Number
2616094|NCT01993927|Primary|Percentage of Participants With Progression to Type 2 Diabetes Mellitus (T2DM) During Treatment Period|"Percentage of participants who occurred progression of T2DM during treatment period was reported. Diagnostic criteria for progression of T2DM are: (1) Blood glucose ≥200 mg/dL at any time, morning fasting blood glucose ≥126 mg/dL, or 2-hour post 75-g (Oral Glucose Tolerance Test) blood glucose ≥200 mg/dL. (2) Two or more glucose measurements obtained on different days that meet the above-mentioned criteria, or (3) A single glucose measurement meeting the above-mentioned criteria if the patient meets any of the following conditions: (i) Has typical symptoms of diabetes mellitus (e.g., dry mouth, polydipsia, polyuria, weight loss) (ii) HbA1C ≥6.5% (JDS value) (iii) Obvious diabetic retinopathy."|Up to Week 72|Safety/Efficacy Analysis Set was defined as all participants who were enrolled and completed the study. Reported data was collected from received case report forms including the data, without major protocol violations.|||Percentage of participants|||Number
2616095|NCT01993927|Primary|Number of Participants Who Experience at Least One Adverse Events||Up to Week 72|Safety/Efficacy Analysis Set was defined as all participants who were enrolled and completed the study. All data could be received as case report forms without major protocol violations.|||Participants|||Count of Participants
2616096|NCT01993888|Secondary|Incidence of Adverse Events That Were Potentially Related to Thrombotic Events|Number of participants with adverse events that were potentially related to thrombic events|Up to 60-days following surgery||||participants|||Number
2616097|NCT01993888|Secondary|Incidence of Adverse Events (AEs)||Up to 60-days following surgery||||participants|||Number
2616098|NCT01993888|Secondary|Incidence of Re-bleeding Events From the TBS During the Study Follow-up||Up to 60-days following surgery||||participants|||Number
2616099|NCT01993888|Secondary|Absolute Time to Hemostasis|The absolute time to achieve hemostasis at or after 4 minutes from randomization.|Intraoperative, an average of 4.2 minutes following randomization|Time to hemostasis (TTH), defined as the absolute time to achieve hemostasis at or after 4 minutes from randomization was evaluated as a secondary endpoint. In one subject in the SoC group, manual compression was not maintained until the 4-minute endpoint, but was released early and a suture was applied, at which point the subject was hemostatic.|||minutes||Full Range|Median
2616100|NCT01993888|Secondary|Hemostasis at the Target Bleeding Site (TBS) at 10-minutes Following Randomization|Proportion of subjects achieving hemostatic success at 10 minutes following randomization and no further bleeding requiring treatment prior to initiation of wound closure.|Intraoperative, 10 minutes following randomization|The proportion of subjects achieving hemostatic success at 10 minutes following randomization was evaluated as a secondary endpoint using the logistic model with treatment and site/institution included in the model.|||participants with hemostatic success|||Number
2616101|NCT01993888|Primary|Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization|Proportion of subjects achieving hemostasis at the TBS at 4-minutes following randomization and with no re-bleeding requiring treatment at the TBS any time prior to initiation of wound closure. Hemostasis is defined as no detectable bleeding at the TBS.|Intraoperative, 4 minutes following randomization|The primary endpoint analysis was based on the Intent to Treat (ITT) analysis set.|||participants with hemostatic success|||Number
2616102|NCT01993875|Secondary|Mean Change From Baseline in Straining at Week 1|Bowel straining was rated as 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The change from baseline was calculated as post-treatment value minus the baseline value.|Week 1|mITT Population|||Units on a scale||Standard Deviation|Mean
2616103|NCT01993875|Secondary|Overall Straining at Week 1|Bowel straining was rated on a scale of 0 to 4 (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe).|Week 1|mITT Population|||Units on a scale||Standard Deviation|Mean
2616104|NCT01993875|Secondary|Mean Change From Baseline in Stool Consistency at Week 1|Stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. The change from baseline was calculated as post-treatment value (mean) minus the baseline value (mean).|Baseline and Week 1|mITT Population|||Units on a scale||Standard Deviation|Mean
2616105|NCT01993875|Secondary|Overall Stool Consistency at Week 1|Overall stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid.|at Week 1|mITT Population|||score on a scale||Standard Deviation|Mean
2616111|NCT01993823|Secondary|Changes in Signs/ Symptoms|"The secondary efficacy variables include:~Proportion of subjects with signs and symptoms score of 0 at Day 15~Proportion of subjects with signs and symptoms score of 0 at Day 24~Proportion of subjects with a negative culture for fungus or presumed eradication (mycological cure) on Day 24."|2 weeks and 4 weeks|ITT|||percentage of patient|||Number
2616112|NCT01993823|Primary|Proportion of Subjects With a Complete Response to Treatment|"Efficacy will be assessed primarily by evaluation of the fungal culture, and the sum of signs and symptom scores (pruritus, otalgia, otorrhea and aural fullness obstruction to be scored as 0=absent; 1= mild; 2=moderate; 3=severe). The primary efficacy variable is the proportion of subjects with a negative culture for fungus, AND a signs and symptom score of 0 on Day 24.~Response to the study treatment was classed according to the following definitions:~Complete response: Negative fungal culture or presumed eradication on day 24, and sum score for signs and symptoms = 0 on day 24.~Partial response: Negative culture or presumed eradication on day 24, and sum score for signs and symptoms = 1 or 2 on day 24.~No response: Positive culture on day 24 or negative culture or presumed eradication and sum score for signs and symptoms > 2 on day 24."|Day 24|ITT|||participants|||Number
2616113|NCT01993667|Secondary|Number of Participants With Side Effects|"The typical side effects of acetazolamide will be measured daily (paresthesias of fingers and toes, change in urination frequency, and change in taste of beverages).~The side effect questionnaire included the following questions: In the past 12 h, have you experienced the following symptoms: Tingling of toes? Tingling of fingers? Increase in urination? Taste change of beverages? Symptoms were self-reported and rated on a 0-5 scale (0=none, 5=maximum)"|12 days|These participants had sufficient data to be included in the analysis.|||Participants|||Count of Participants
2616114|NCT01993667|Primary|Number of Participants With Acute Mountain Sickness as Measured by the Lake Louise Score|Lake Louise Score, A total score of 3 to 5 indicates mild AMS. A score of 6 or more signifies severe AMS. Minimum value - 0, Maximum = 15|12 days|Seventy-three participants had sufficient data to be included in the analysis.|||Participants|||Count of Participants
2616115|NCT01993238|Secondary|Pain Scores Reported at 1-day Post-Treatment|During the 1-day follow-up phone call, subjects were asked to rate the pain they were currently experiencing from the Liposonix treatment using a 0-10 pain scale (0 represents no pain and 10 represents worst pain imaginable).|1 day|Intent-to-Treat|||units on a scale||Standard Deviation|Mean
2616116|NCT01993238|Secondary|Safety Assessment|Adverse events will be assessed and documented throughout the study|Baseline, 1 day, 1 week|||||||
2616117|NCT01993238|Primary|Pain Score for Overall Treatment|Following treatment, the subject was asked to evaluate the pain level for the overall treatment using the 0-10 Visual Analog Scale (0 represents no pain and 10 represents worst imaginable pain)|Baseline|Intent to Treat|||units on a scale||Standard Deviation|Mean
2616118|NCT01993108|Secondary|Characterize the Effects of Methylphenidate and Naltrexone on Neural Circuits in Prefrontal Cortex Associated With Top-down Control.|The effects of methylphenidate, naltrexone, and placebo on the change in BOLD (Blood Oxygen Level Dependent) signal will be characterized in the incongruent condition (cognitive regulation condition) of the MSIT (multi-source interference task) relative to the congruent condition (no regulation condition). Specifically, the summed BOLD signal in three regions--dorsal lateral prefrontal cortex, anterior insula, anterior cingulate--are measured.|Two hours||||Mean percentage of BOLD signal change||Standard Deviation|Mean
2616119|NCT01993108|Secondary|Accuracy on the Multi-Source Interference Task|Accuracy is the calculated percentage of correct responses over total trials in the Multi-Source Interference Task.|Two hours||||percent of total trials||Standard Deviation|Mean
2616120|NCT01993108|Secondary|Reaction Time on the Multi-Source Interference Task|Reaction time of the Multi-Source Interference Task is measured in seconds.|Two hours||||seconds||Standard Deviation|Mean
2616121|NCT01993108|Primary|Reaction Time Variability on the Multi-Source Interference Task|Multi-Source Interference Task is a psychological task that measures the psychological construct of cognitive control, the ability to suppress automatic response tendencies. Reaction time variability is the standard deviation of the trial to trial reaction time measured in seconds.|2 hours||||seconds||Standard Deviation|Mean
2616122|NCT01993030|Primary|Time to Wound Healing|Healing time was recorded when complete re-epithelialization had occurred. If the wound healed in advance, visit until the wound was completely healed. If the wounds were unable to heal for more than 21±3 days, unanticipated follow-ups were added until the wound was completely healed.|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation||||Days||Standard Deviation|Mean
2616123|NCT01993030|Secondary|Number of Participants With Exudation|"Physician assessment determined presence of exudation by observing whether the gauze over the primary wound dressings was soaked by exudation:~Less than two gauze was soaked by exudation within 24h---No exudation (-);~Two to four gauze was soaked by exudation within 24h---Little exudation (+);~More than four gauze was soaked by exudation within 24h---Much exudation (++);"|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation||||participants|||Number
2616124|NCT01993030|Secondary|Pain Perceived by Patient|The amount of pain that a patient perceived was assessed using a Visual Analogue Scale (VAS 0-10), which ranges across a continuum from 0 (no pain) to 10 (worst pain).|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation||||units on a scale||Standard Deviation|Mean
2616125|NCT01993030|Secondary|Number of Participants With Inflammatory Reaction|Physician assessment determined presence of inflammatory reaction which is characterized by pain, heat, redness and swelling.|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation||||participants|||Number
2616126|NCT01993030|Secondary|Number of Participants With Growth of Granulation Tissue|Physician assessment of tissue with healthy granulation tissue defined as is granular and uneven in texture, does not bleed easily and is pink in color. Unhealthy granulation tissue is typically dark which can be indicative of poor perfusion, ischemia and/or infection.|Days 0, 3±1, 7±1, 10±2, 14±3, and 21±3 post-operation||||participants|||Number
2616127|NCT01993017|Secondary|Cost of Health Care Utilization|"Total cost of health care utilization from baseline through 18 months post-randomization~*Note: There is a delay in reporting this outcome due to time required to compile and analyze electronic health record data from 4 health care systems."|Baseline through 18 months||2020-03-31|03/2020||||
2616128|NCT01993017|Secondary|Depression-free Days|Depression-free days from baseline through 18 months post-randomization|Baseline through 18 months||||cumulative depression-free days||Standard Deviation|Mean
2616129|NCT01993017|Primary|Quality-Adjusted Life Years (QALYs)|Change in QALYs from baseline through 18 months. QALYs are a generic measure of disease burden, including both the quality and the quantity of life lived. One QALY equates to one year in perfect health. To measure change in QALYs, utility scores [an overall assessment of well-being on a scale from 0 (death) to 1 (perfect health)], were estimated using the Short Form-6 dimension, with scores derived from responses to the 12-Item Short-Form Health Survey, version 2, at baseline and 6, 12, and 18 months. QALYs for the period from baseline to 18 months were then calculated as the area under the curve by linearly interpolating the utility scores at the 4 assessments. Change in QALYs was then obtained by subtracting the baseline QALY from the observed QALY for an 18-month period, where baseline QALY was calculated under the assumption that the baseline utility score remained constant during the 18-month period.|Baseline, 6, 12 and 18 months||||quality-adjusted life years (QALYs)||Standard Deviation|Mean
2616130|NCT01992874|Secondary|Part B: Number of Subjects Who Experienced Progressive Disease (PD)|PD as per RECIST v1.1 defined as 20% increase in sum of diameters of target lesions; the appearance of >=1 new lesions.|Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.|||subjects|||Number
2616131|NCT01992874|Secondary|Part B: Number of Subjects Who Experienced Stable Disease (SD)|SD as per RECIST v1.1 defined as neither shrinkage to qualify for PR nor increase to qualify for progressive disease (PD) taking the smallest sum diameters on study as reference. PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; PD = 20% increase in sum of diameters of target lesions; the appearance of >=1 new lesions.|Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.|||subjects|||Number
2616132|NCT01992874|Secondary|Part B: Number of Subjects Who Experienced Partial Response (PR)|PR as per RECIST v1.1 defined as 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters.|Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.|||subjects|||Number
2616133|NCT01992874|Secondary|Part B: Number of Subjects Who Experienced Complete Response (CR)|CR as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 defined as disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to less than (<)10 millimeter (mm).|Screening to Day 1 of each cycle (21 day in each cycle) until disease progression, intolerable toxicity, withdrawal of consent or death; assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.|||subjects|||Number
2616134|NCT01992874|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation|An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug administration until 30 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pre treatment state.|From the first dose of study drug administration until 30 days after the last dose of study drug administration, assessed up to 14 Months|Safety analysis set included all subjects who received at least one dose of IMP.|||subjects|||Number
2616135|NCT01992874|Primary|Area Under the Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUC 0-t)|Area under the plasma concentration-time curve from time zero to the last sampling time (AUC0-t) at which the concentration was at or above the lower limit of quantification.|Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2616136|NCT01992874|Secondary|Terminal Rate Constant (λz)||Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.|||1/h||Full Range|Median
2616137|NCT01992874|Secondary|Apparent Volume of Distribution (Vz/f)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2616138|NCT01992874|Secondary|Apparent Total Body Clearance (CL/f)|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.|||liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2616388|NCT01990768|Secondary|Number of Participants With Pulmonary Embolus (PE)|Diagnosis of PE|From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)|Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.|||Participants|||Count of Participants
2616139|NCT01992874|Secondary|Apparent Terminal Half-life (t1/2)||Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analyzed) signifies the number of subjects analysed for this outcome measure.|||hour||Full Range|Median
2616140|NCT01992874|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability.|||hour||Full Range|Median
2616141|NCT01992874|Secondary|Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC0-inf)||Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|PK analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability. Here N (number of participants analysed) signifies the number of subjects analysed for this outcome measure.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2616142|NCT01992874|Primary|Maximum Observed Plasma Concentration (Cmax)|Maximum observed plasma concentration (Cmax) was calculated for Part A Pimasertib 60 mg Capsule and tablet.|Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 8, and 24 hours post-dose on Day 1 and 3|Pharmacokinetic (PK) analysis set included all subjects who received the Part A IMP, had compliance with IMP intake in Part A, at least one post-treatment PK sample from each treatment period and absence of protocol deviations affecting bioavailability.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2616143|NCT01992757|Secondary|Difference in Clauss Assay and FLEV|This secondary outcome aimed to determine if standard laboratory assays for fibrinogen (Clauss) provided values similar to TEG-based functional fibrinogen (FLEV). The difference between the means at various timepoints is calculated in mg/dL.|Clauss vs FLEV for rewarming and post-CPB|49 patients undergoing cardiac surgery with CPB. The measure is the difference of the FLEV and the Clauss assay (i.e. FLEV minus Clauss since the FLEV is consistently higher).|||mg/dL||95% Confidence Interval|Mean
2616144|NCT01992757|Primary|Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV)|FLEV values obtained during rewarming while on cardiopulmonary bypass (CPB) were compared to FLEV values obtained immediately after CPB and protamine administration. For all patients included, the mean values for rewarming FLEV and mean values for post-CPB FLEV were obtained. If the mean difference for the two timepoints was not statistically different by t-test, then the primary outcome would demonstrate the value of obtaining a rewarming FLEV sample.|Change in FLEV from rewarming and after cardiopulmonary bypass|49 patients undergoing cardiac surgery with CPB.|||mg/dL||95% Confidence Interval|Mean
2616145|NCT01992653|Secondary|Overall Survival for Non-DLBCL Population|The time from the date of randomization to the date of death from any cause. For participants who did not die at the time of the analyses, OS was censored on the last date when the participants were known to be alive.|Screening up to death due to any cause (up to approximately 6 years)|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.|||Months||95% Confidence Interval|Median
2616146|NCT01992653|Secondary|Overall Survival for DLBCL Population|The time from the date of randomization to the date of death from any cause. For participants who did not die at the time of the analyses, OS was censored on the last date when the participants were known to be alive.|Screening up to death due to any cause (up to approximately 6 years)|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.|||Months||95% Confidence Interval|Median
2616147|NCT01992653|Secondary|Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for Non-DLBCL Population|Relative dose intensity (DI) was defined as the ratio of the amount of a drug actually administered (actual DI) to the amount planned (planned DI) for a fixed time period, expressed as a percentage.|6 months|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.|||Percentage||Standard Deviation|Mean
2616148|NCT01992653|Secondary|Relative Dose Intensity of Polatuzumab Vedotin (Ratio of the Amount of Drug Actually Administered to the Amount Planned) for DLBCL Population|Relative dose intensity (DI) was defined as the ratio of the amount of a drug actually administered (actual DI) to the amount planned (planned DI) for a fixed time period, expressed as a percentage.|6 months|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.|||Percentage||Standard Deviation|Mean
2616149|NCT01992653|Secondary|Event Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population|Time from randomization to disease progression or relapse, as assessed by the investigator, death from any cause, or initiation of any new anti-lymphoma therapy (NALT). If the specified event (disease progression or relapse, death, initiation of a NALT) did not occur, EFS was censored at the date of last tumor assessment. For participants without an event who did not have post-baseline tumor assessments, EFS was censored at the time of randomization.|Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.|||Months||95% Confidence Interval|Median
2616150|NCT01992653|Secondary|Event Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population|Time from randomization to disease progression or relapse, as assessed by the investigator, death from any cause, or initiation of any new anti-lymphoma therapy (NALT). If the specified event (disease progression or relapse, death, initiation of a NALT) did not occur, EFS was censored at the date of last tumor assessment. For participants without an event who did not have post-baseline tumor assessments, EFS was censored at the time of randomization.|Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.|||Months||95% Confidence Interval|Median
2616151|NCT01992653|Secondary|Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population|Time from date of first dose of study drug (Day 1) to the first occurrence of progression or relapse, or death from any cause while in the study, as assessed by the investigator. If a participant did not experience progressive disease or death, PFS was censored on the day of the last tumor assessment. If a post-baseline assessment was not available, PFS was censored on Day 1.|Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.|||Months||95% Confidence Interval|Median
2616152|NCT01992653|Secondary|Progression Free Survival, as Assessed by Investigator Using Cheson Criteria for DLBCL Population|Time from date of first dose of study drug (Day 1) to the first occurrence of progression or relapse, or death from any cause while in the study, as assessed by the investigator. If a participant did not experience progressive disease or death, PFS was censored on the day of the last tumor assessment. If a post-baseline assessment was not available, PFS was censored on Day 1.|Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.|||Months||95% Confidence Interval|Median
2616153|NCT01992653|Secondary|Duration of Response, as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population|Time from the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse or death from any cause (PFS), as assessed by the investigator for the subgroup of participants with a best overall response of CR or PR. For participants achieving a response who did not experience disease progression, relapse, or died prior to the time of the analysis, the DOR was censored on the date of last disease assessment.|Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.|||Months||95% Confidence Interval|Median
2616154|NCT01992653|Secondary|Duration of Response, as Assessed by Investigator Using Cheson Criteria for DLBCL Population|Time from the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse or death from any cause (PFS), as assessed by the investigator for the subgroup of participants with a best overall response of CR or PR. For participants achieving a response who did not experience disease progression, relapse, or died prior to the time of the analysis, the DOR was censored on the date of last disease assessment.|Screening up to disease progression or death, whichever occurs first (up to approximately 2.75 years)|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.|||Months||95% Confidence Interval|Median
2616155|NCT01992653|Secondary|Peripheral Neuropathy Symptom Interference: TINAS Numbness/Tingling Item Score|The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the patient can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Additionally, a single item that asks patients to rate when numbness and tingling was at the worst will be used to predict the onset of peripheral neuropathy. The measure takes less than 5 minutes to complete. Results are only being reported here up until the End of Treatment visit (duration of Study treatment).|Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.|The safety population was defined as all participants who have received at least one dose of study medication. TINAS was only assessed in the 'Expansion' cohorts and only participants for whom data were collected are included in the analysis.|||Score of a Questionnaire||Standard Deviation|Mean
2616156|NCT01992653|Secondary|Peripheral Neuropathy Symptom Severity: Therapy-Induced Neuropathy Assessment Scale (TINAS) Overall Neuropathy Severity Score|The TINAS is an 11-item questionnaire scored on a 0 to 10 scale, with 0 being the symptom is not present to 10 being the symptom is as bad as the participant can imagine. The questionnaire will be analyzed for the individual neuropathy symptoms experienced by a participant as well as the calculation of an overall neuropathy severity score. The TINAS scale will be completed daily over the course of study treatment. Additionally, to collect information about the reversibility of peripheral neuropathy, the TINAS will be completed once a week for the first 2 months, then once a month for the next 10 months following treatment completion. Results are only being reported here up until the End of Treatment visit (duration of Study treatment).|Weekly up to Month 6 (22 weeks). TINAS data were collected daily, though for the analysis purpose for each participant, only the first record of each week was selected.|The safety population was defined as all participants who have received at least one dose of study medication. TINAS was only assessed in the 'Expansion' cohorts and only participants for whom data were collected are included in the analysis.|||Score of a Questionnaire||Standard Deviation|Mean
2616157|NCT01992653|Secondary|Plasma Levels of Doxorubicin|Plasma levels of doxorubicin will be assessed and compared at the same timepoints of Cycle 1 (in the absence of polatuzumab vedotin) and Cycle 3 (in the presence of polatuzumab vedotin), and compared with historical data to evaluate potential PK interactions with polatuzumab vedotin.|2, 24 hours post end of doxorubicin infusion (infusion time=15 min) on D1 of Cy 1 and 3 (cycle length=21 days)|The safety population was defined as all participants who have received at least one dose of study medication. Plasma levels of doxorubicin were only assessed in the 'Expansion' cohorts and only participants for whom data were collected are included in the analysis.|||ug/mL||Standard Deviation|Mean
2616167|NCT01992653|Secondary|Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for DLBCL Population|Complete Response (CR) rate was defined as the percentage of participants with CR at the end of treatment, as assessed by the investigator, with and without FDG-PET. The overall response rate was defined as the percentage of participants with CR or PR at the end of treatment, as assessed by the investigator, with and without FDG-PET.|At the end of treatment (Month 6)|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.|||Percentage of Participants||90% Confidence Interval|Number
2616158|NCT01992653|Secondary|Plasma Levels of Cyclophosphamide|Plasma levels of cyclophosphamide will be assessed and compared at the same timepoints of Cycle 1 (in the absence of polatuzumab vedotin) and Cycle 3 (in the presence of polatuzumab vedotin), and compared with historical data to evaluate potential PK interactions with polatuzumab vedotin.|End of cyclophosphamide infusion (infusion time=1-24 Hr), 3 and 23 hours post end of cyclophosphamide infusion on D1 of Cy 1 and 3 (cycle length=21 days)|The safety population was defined as all participants who have received at least one dose of study medication. Plasma levels of cyclophosphamide were only assessed in the 'Expansion' cohorts and only participants for whom data were collected are included in the analysis.|||ug/mL||Standard Deviation|Mean
2616159|NCT01992653|Secondary|Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin|Vss for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.|Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.|||mL/kg||Standard Deviation|Mean
2616160|NCT01992653|Secondary|Terminal Half-Life (t1/2) of Polatuzumab Vedotin|t1/2 for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.|Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.|||days||Standard Deviation|Mean
2616161|NCT01992653|Secondary|Clearance (CL) of Polatuzumab Vedotin|CL for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.|Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.|||mL/day/kg||Standard Deviation|Mean
2616162|NCT01992653|Secondary|Maximum Concentration (Cmax) of Polatuzumab Vedotin|Cmax for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.|Pre-polatuzumab vedotin infusion (Hr 0), 30 min post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.|||ng/mL||Standard Deviation|Mean
2616163|NCT01992653|Secondary|Area Under the Concentration-Time Curve (AUC) of Polatuzumab Vedotin|AUC information for Polatuzumab Vedotin was estimated from serum concentration data using non-compartmental analysis.|Pre-polatuzumab vedotin infusion (Hr 0), 30 minutes (min) post-infusion (infusion time=30-90 min) on D 2 of Cy 1, 2 & D1 of Cy 3, 4; Cy 1 Days 8 & 15; Cy 3 Day 8; at end of treatment (Month 6), at Month 3 follow-up (Month 9) (cycle length=21 days)|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.|||ng day/mL||Standard Deviation|Mean
2616164|NCT01992653|Secondary|Number of Participants With Anti-Obinutuzumab Antibodies|The ADA screening assay was optimized to tolerate drug interference and was able to detect 500 ng/mL of the ADA-positive control sample in the presence of 50 micrograms/mL of obinutuzumab. Obinutuzumab concentrations were determined for each ADA sample. Out of a total of 48 ADA samples that were measured for obinutuzumab, 9 samples had levels less than 50 micrograms/mL of obinutuzumab. Obinutuzumab concentrations in ADA samples ranged from 0.282 micrograms/mL to 522 micrograms/mL with a median concentration of 210 micrograms/mL. Therefore, it is possible that samples with obinutuzumab concentrations greater than 50 micrograms/mL might be false negative for ADA.|Baseline up to Month 9 (assessed prior to obinutuzumab infusion [0 Hr] on D1 of Cy 1, 2, 4 and at 3 months post-treatment [Month 9]; cycle length=21 days)|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.|||Participants|||Count of Participants
2616165|NCT01992653|Secondary|Number of Participants With Anti-Polatuzumab Vedotin Antibodies|The Anti-Drug Antibody (ADA) screening assay was optimized to tolerate drug interference and was able to detect 90 and 500 ng/mL of the positive control sample in the presence of 20 μg/mL of polatuzumab vedotin. Polatuzumab vedotin total antibody concentrations were determined for each ADA sample. Out of a total of 186 ADA samples that were measured for polatuzumab vedotin total antibody, 184 samples had levels less than 20 μg/mL. Polatuzumab vedotin total antibody concentrations ranged from <0.050 μg/mL to 52.1 μg/mL with a median concentration of 3.38 μg/mL.|Baseline up to Month 9 (assessed prior to polatuzumab vedotin infusion [0 hour; Hr] on Day 2 [D2] of Cy 1 and 2, D1 of Cy 4, treatment completion/early termination [Month 6], and at 3 months post-treatment [Month 9]; cycle length=21 days)|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL and Non-DLBCL.|||Participants|||Count of Participants
2616166|NCT01992653|Secondary|Percentage of Participants With Objective Response (CR or Partial Response [PR]), as Assessed by Investigator Using Cheson Criteria for Non-DLBCL Population|Complete Response (CR) rate was defined as the percentage of participants with CR at the end of treatment, as assessed by the investigator, with and without FDG-PET. The overall response rate was defined as the percentage of participants with CR or PR at the end of treatment, as assessed by the investigator, with and without FDG-PET.|At the end of treatment (Month 6)|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.|||Percentage of Participants||90% Confidence Interval|Number
2616178|NCT01992536|Secondary|25. Number of Subjects With Unsolicited Adverse Events Following Booster Vaccination in This Study.|Number of subjects reporting any serious unsolicited AEs (SAEs), possibly related SAEs, medically attended AEs, unsolicited AEs leading to withdrawal and deaths after receiving a booster dose of MenABCWY vaccine or placebo, are reported for the entire study period.|Day 1 to Day 365|Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.|||Participants|||Number
2616168|NCT01992653|Primary|Number of Participants With DLTs in Non-DLBCL Population|All dose-escalation cohorts will consist of at least 3 participants. If a DLT is observed in 1 participant at a given dose level during the DLT observation period before dose escalation, additional participants will be enrolled at that dose level for a total of at least 6 participants. DLT assessment forms part of determining the Maximum Tolerated Dose (MTD). The highest dose level resulting in DLTs in less than one-third of a minimum of 6 participants will be declared the MTD.|Cycle (Cy) 1 Day 1 (D1) to Cy 2 D1 (cycle length=21 days)|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.|||Participants|||Count of Participants
2616169|NCT01992653|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in DLBCL Population|All dose-escalation cohorts will consist of at least 3 participants. If a DLT is observed in 1 participant at a given dose level during the DLT observation period before dose escalation, additional participants will be enrolled at that dose level for a total of at least 6 participants. DLT assessment forms part of determining the Maximum Tolerated Dose (MTD). The highest dose level resulting in DLTs in less than one-third of a minimum of 6 participants will be declared the MTD.|Cycle (Cy) 1 Day 1 (D1) to Cy 2 D1 (cycle length=21 days)|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.|||Participants|||Count of Participants
2616170|NCT01992653|Primary|Number of Participants With Adverse Events in Non-DLBCL Population|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).|Baseline up to 5 years|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with Non-DLBCL.|||Participants|||Count of Participants
2616171|NCT01992653|Primary|Number of Participants With Adverse Events in Diffuse Large B-Cell Lymphoma (DLBCL) Population|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).|Baseline up to 5 years|The safety population was defined as all participants who have received at least one dose of study medication. Results were reported for participants with DLBCL.|||Participants|||Count of Participants
2616172|NCT01992549|Secondary|The Occurrence of Any Adverse Event (AE)|The frequency of AEs, as monitored throughout the whole study by the number of patients with at least one adverse event occurrence.|Maximum 2 years|The analysis was performed for the safety (SAF) population which includes all patients who received at least 1 infusion of Human-cl rhFVIII (n=48).|||Participants|||Count of Participants
2616173|NCT01992549|Secondary|Efficacy of Human-cl rhFVIII for Surgical Prophylaxis|"An overall efficacy assessment to assess the efficacy of human-cl rhFVIII in surgical prophylaxis of minor and major surgeries. The efficacy assessment was analyzed using a four-point scale (excellent, good, moderate, none). If surgeries could not be assessed due to limited data available or having taken place outside the study site, the results were classified as not done."|Maximum 2 years|The analysis population includes 3 patients that received Human-cl rhFVIII for surgical prophylaxis during a total of 4 surgeries (SURG population). Of these, 1 patient had two minor surgeries and 2 patients had one major surgery each.|||Surgeries|Surgeries||Count of Units
2616174|NCT01992549|Secondary|Efficacy of Human-cl rhFVIII for the Treatment of Bleeds|A personal efficacy assessment (final outcome) to assess the efficacy of Human-cl rhFVIII for the on-demand treatment of bleeding episodes (BEs) at the end of a BE. Efficacy was assessed using a four-point scale (excellent, good, moderate, none) by the patient's parent(s)/legal guardian(s) together with the investigator in case of on site treatment.|Maximum 2 years|The analysis population included all patients who received on-demand treatment with Human-cl rhFVIII for bleeding episodes (BLEED population; n=29).|||Bleeding episodes|Bleeding episodes||Count of Units
2616175|NCT01992549|Secondary|Frequency of Spontaneous Break-through Bleeds|The annualized bleeding rate (ABR) was calculated during the time of prophylactic treatment with Human-cl rhFVIII for spontaneous bleeding events (BEs).|Maximum 2 years|The analysis population includes all patients in PROPH population who received at least one prophylactic treatment with Human-cl rhFVIII (n=47).|||Events/year (ABR)||95% Confidence Interval|Mean
2616176|NCT01992549|Primary|Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors|"The number of patients developing FVIII inhibitors was observed during the observation period by assessing inhibitor development by the modified Bethesda assay (Nijmegen modification) using congenital FVIII-deficient human plasma spiked with Human-cl rhFVIII. The definition threshold for a positive inhibitor was if the modified Bethesda assay resulted in a titre ≥0.6 BU/mL at any time point during the observation period."|Maximum two years|The analysis was performed for the safety (SAF) population which includes all patients who received at least 1 infusion of Human-cl rhFVIII (N=48)|||participants||95% Confidence Interval|Number
2616177|NCT01992536|Secondary|26. Number of Subjects With Unsolicited Adverse Leading to New Onset Chronic Disease (NOCD) Before Study Vaccination.|Number of subjects reporting New Onset Chronic Disease (NOCD),from the end of the primary parental study V102_03 (NCT01272180) up to Day 1 visit in V102_03E1 study, is reported. (Any NOCD AEs: NOCD V102_03 (NCT01272180) vs. NOCD- Day 1, V102_03E1)|From primary parent study completion up to Day 1 in this study.|Analysis was done on the all enrolled set population. All screened subjects who have been enrolled (ie, attended the first clinic visit and received a subject ID).|||Participants|||Number
2616179|NCT01992536|Secondary|24. Number of Subjects With Unsolicited (Any AEs and Possibly Related AEs) Following Booster Vaccination in This Study.|"Number of subjects reporting unsolicited AEs (any AEs and at least possibly related AEs) after receiving a booster dose of MenABCWY vaccine or placebo from Day 1 to Day 30.~Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30."|Day 1 through Day 30|Analysis was done on the Unsolicited Safety Set. All subjects in the exposed population who provided information about post-vaccination AEs or safety records at Day 30.|||Participants|||Number
2616180|NCT01992536|Secondary|23. Number of Subjects With Solicited Local and Systemic Adverse Events Following Booster Vaccination in This Study.|Number of subjects reporting solicited local and systemic adverse events after receiving a booster dose of MenABCWY vaccine or placebo. the below reported events are Erythema- Injection site erythema, Induration- Injection site induration, Pain-injection site pain, Arthralgia, Chills, Fatigue, Headache, Loss of Appetite, Myalgia, Nausea, Rash, Fever, Prevention- Prevention of Pain and/or Fever, Treatment- Treatment of Pain and/or Fever and Analgesic/Antipyr.: use of Analgesic/Antipyretics in pain and fever.|From day 1 (6 hours) through day 7 after any vaccination|Analysis was done on the Solicited Safety Set, i.e. all exposed subjects who provide post vaccination solicited adverse event data.|||Participants|||Number
2616181|NCT01992536|Secondary|22. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A,C,W,Y at 12 Months After Booster Vaccination.|Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination in this study.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Percentages of Subjects||95% Confidence Interval|Number
2616182|NCT01992536|Secondary|21. The HT-hSBA GMTs Against Neisseria Meningitidis Strains of Serogroups B.|The HT-hSBA GMTs against Neisseria meningitidis strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Titers||95% Confidence Interval|Geometric Mean
2616183|NCT01992536|Secondary|20. The HT-hSBA GMTs Against Neisseria Meningitidis Serogroups A, C, W,Y and Strains of Serogroups B.|The HT-hSBA GMTs against Neisseria meningitidis serogroup A, C, W, Y and strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Titers||95% Confidence Interval|Geometric Mean
2616184|NCT01992536|Secondary|19. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.|Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitides strains of serogroups B at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Percentages of Subjects||95% Confidence Interval|Number
2616185|NCT01992536|Secondary|18. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.|Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y at Day 1, Day 30 (one month) and Day 365 (12 months) after the administration of MenABCWY booster vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Percentages of Subjects||95% Confidence Interval|Number
2616186|NCT01992536|Secondary|17. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.|The HT-hSBA GMTs against N. meningitidis strains of serogroups B, at 24 and 36 months after the primary vaccination.|Day 1 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Titers||95% Confidence Interval|Geometric Mean
2616187|NCT01992536|Secondary|16. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.|The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y, at 24 and 36 months after the primary vaccination.|Day 1 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Titers||95% Confidence Interval|Geometric Mean
2616188|NCT01992536|Secondary|15. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.|"Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, at 24 and 36 months after the primary vaccination.~Four-fold rise is defined as follows: for subjects with a pre-vaccination titer < 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase."|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster). All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Percentages of Subjects||95% Confidence Interval|Number
2616189|NCT01992536|Secondary|14. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B|Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B, at 24 and 36 months after the primary vaccination.|Day 1, Day 30 and Day 365|Analysis was done on FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Percentages of Subjects||95% Confidence Interval|Number
2616389|NCT01990768|Secondary|Number of Participants With Deep Vein Thrombosis (DVT)|Diagnosis of DVT|From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)|Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.|||Participants|||Count of Participants
2616190|NCT01992536|Secondary|13. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitidis Serogroups A, C, W,Y.|Percentage of subjects with HT-hSBA titer ≥ 1:8 against N. meningitidis serogroups A, C, W, Y, at 24 and 36 months after the primary vaccination.|Day 1 and Day 365|Analysis was done on the FAS Day 365 (Persistence of Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 365.|||Percentages of Subjects||95% Confidence Interval|Number
2616191|NCT01992536|Secondary|12. Percentage of Subjects With Seroresponse to N. Meningitidis Serogroups A, C, W and Y, at Day 30 After Booster Vaccination in This Study.|Percentage of subjects with seroresponse to N. meningitidis serogroup A, C, W and Y, at Day 30 after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.|Day 30|Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).|||Percentages of Subjects||95% Confidence Interval|Number
2616192|NCT01992536|Secondary|11. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 Against N. Meningitidis Serogroup B Strains.|Percentage of subjects with HT-hSBA titer ≥ 1:5 to N. meningitidis serogroup B strains at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).|||Percentages of Subjects||95% Confidence Interval|Number
2616193|NCT01992536|Secondary|10. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 Against N. Meningitidis Serogroups A,C,W,Y.|Percentage of subjects with HT-hSBA titer ≥ 1:8 to N. meningitidis serogroups A,C,W,Y at Day 1 and Day 30 (one month) after the administration of a booster dose of MenABCWY vaccine or placebo in this study, versus baseline.|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).|||Percentages of Subjects||95% Confidence Interval|Number
2616194|NCT01992536|Secondary|9. Percentage of Subjects With Four-fold Rise in HT-hSBA Titers Against N. Meningitidis Serogroup B Strains.|"Percentage of subjects with four-fold rise in HT-hSBA titers against N. meningitidis serogroup B strains, from Day 1 (baseline) to Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.~Four-fold rise is defined as follows: for subjects with a pre-vaccination titer < 1:2, a post-titer of ≥ 1:8; for subjects with a pre-vaccination titer ≥ 1:2 at least a four-fold increase."|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).|||Percentages of Subjects||95% Confidence Interval|Number
2616195|NCT01992536|Secondary|8. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroups B.|The HT-hSBA GMTs against N. meningitidis strains of serogroups B at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).|||Titers||95% Confidence Interval|Geometric Mean
2616196|NCT01992536|Secondary|7. The HT-hSBA GMTs Against N. Meningitidis Serogroups A, C, W, Y.|The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y at Day 1 and Day 30 (one month) after the administration of MenABCWY booster vaccination or placebo.|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).|||Titers||95% Confidence Interval|Geometric Mean
2616197|NCT01992536|Secondary|6. The HT-hSBA GMTs Against N. Meningitidis Strains of Serogroup B.|"The HT-hSBA GMTs against N. meningitidis strains of serogroup B prior the administration of MenABCWY booster vaccination or placebo.~Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180)."|Day 1 (Pre-vaccination)|Analysis was done on the FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.|||Titers||95% Confidence Interval|Geometric Mean
2616198|NCT01992536|Secondary|5. The HT-hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W,Y.|"The HT-hSBA GMTs against N. meningitidis serogroup A, C, W, Y prior the administration of MenABCWY booster vaccination or placebo.~Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180)."|Day 1 (Pre-vaccination)|Analysis was done on FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.|||Titers||95% Confidence Interval|Geometric Mean
2616199|NCT01992536|Secondary|4. Percentage of Subjects With HT-hSBA Titer ≥ 1:5 to N. Meningitidis Strains of Serogroup B.|"Percentage of subjects with HT-hSBA titer ≥ 1:5 against N. meningitidis strains of serogroup B assessed prior to the administration of MenABCWY booster vaccination or placebo.~Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180)."|Day 1 (Pre vaccination)|Analysis was done on the FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.|||Percentages of Subjects||95% Confidence Interval|Number
2616200|NCT01992536|Secondary|3. Percentage of Subjects With HT-hSBA Titer ≥ 1:8 to N. Meningitides Serogroups A, C, W, Y.|"Percentage of subjects with HT-hSBA titer ≥ 1:8 in serogroups A, C, W, Y against N. meningitides assessed prior to the administration of MenABCWY booster vaccination or placebo.~Pre vaccination is 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102_03 (NCT01272180)."|Day 1 (Pre vaccination)|Analysis was done on FAS Day 1 (Persistence) population. All subjects in the enrolled population who provided an evaluable serum sample at Day 1.|||Percentages of Subjects||95% Confidence Interval|Number
2616201|NCT01992536|Primary|2. Percentage of Subjects With HT-hSBA Titers ≥ 1:5 Against Strains of N. Meningitidis Serogroups B.|Percentage of subjects reporting HT-hSBA titers ≥ 1:5 against strains of N. meningitidis serogroups B at baseline (Day 1) and one month (Day 30) following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180).|Day 1 and Day 30|Analysis was done on FAS Day 30 (Booster) population. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).|||Percentages of Subjects||95% Confidence Interval|Number
2616202|NCT01992536|Primary|1. Percentages of Subjects With HT-hSBA (High-throughput Human Serum Bactericidal Assay) Seroresponse Against N. Meningitidis Serogroups A, C, W and Y.|Percentages of subjects having HT-hSBA seroresponse against N. meningitidis serogroups A, C, W and Y, following administration of a booster dose of MenABCWY, in the present study, in subjects who previously received the same MenABCWY vaccine formulation in study V102_03 (NCT01272180). Seroresponse to N. meningitidis serogroups A, C, W and Y is defined as: for subjects with a pre-vaccination HT-hSBA titer < 1:4, a post-vaccination hSBA titer ≥ 1:8; for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.|Day 30|Analysis was done on FAS Day 30 (Booster) population.. All subjects in the enrolled population who were randomized, actually received the study vaccination in V102_03E1 and provided an evaluable serum sample at Day 30 (for seroresponse, Day 1 and Day 30 samples were required).|||Percentages of Subjects||95% Confidence Interval|Number
2616203|NCT01992523|Secondary|Dyspnoea and/or Symptomatic Bradycardia|Percentage of participants with Occurrence of dyspnoea and/or symptomatic bradycardia|6 months|Continuous data were expressed as mean ± standard deviation or medians (quartiles) as appropriate, and categorical data as proportions (%)|||percentage of partecipants|||Number
2616204|NCT01992523|Secondary|Bleeding Events|Percentage of participants with Major, minor, minimal bleeding (TIMI criteria) events|48 hours||||percentage of partecipants|||Number
2616205|NCT01992523|Secondary|High Residual Platelet Reactivity|The percent of patients with a high residual platelet reactivity (PRU > 208) 1 hour after ticagrelor LD.|1 hour|Categorical data were expressed as proportions (%)|||percentage of partecipants|||Number
2616206|NCT01992523|Primary|Residual Platelet Reactivity|residual platelet reactivity by Platelet Reactivity Units (PRU) VerifyNow 1 hour after ticagrelor LD.|1 hour|Continuous data were expressed as mean ± standard deviation or medians (quartiles) as appropriate, and categorical data as proportions (%). A P value < .05 was considered statistically significant. All tests were two-sided.|||PRU (P2Y12 reaction units)||Inter-Quartile Range|Median
2616207|NCT01992354|Secondary|Device Complaints|Number of device complaints reported during a scan|One day||||Device complatints reported|||Number
2616208|NCT01992354|Primary|PET/MR Scan Obtained|One PET/MR scan per subject should be obtained. The scan images are evaluated by a subject matter expert for adequate diagnostic quality.|One (1) day||||scans completed|||Number
2616209|NCT01992185|Primary|Percent Repigmentation||90 days||||Percent Repigmentation||Standard Deviation|Mean
2616210|NCT01992172|Primary|Number of Pruritus Events in Last 30 Days||30 days from baseline||||Events||Standard Deviation|Mean
2616211|NCT01992159|Secondary|Area Under the Curve Through Month 12 of P1NP||Baseline, week 1 and months 1, 2, 3, 6, 9, and 12.|Randomized participants who received at least 10 doses of the assigned randomized treatment, had never received any dose of incorrect treatment, and had no missing P1NP measurements.|||ug*month/L||95% Confidence Interval|Least Squares Mean
2616212|NCT01992159|Secondary|Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP)||Baseline, week 1, and months 1, 2, 3, 6, 9, and 12|Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, had at least 1 postbaseline measurement, and with available data at each time point.|||percent change||Standard Deviation|Mean
2616213|NCT01992159|Secondary|Percent Change From Baseline in Osteocalcin||Baseline, week 1, and months 1, 2, 3, 6, 9, and 12|Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, had at least 1 postbaseline measurement, and with available data at each time point.|||percent change||Standard Deviation|Mean
2616214|NCT01992159|Secondary|Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX)||Baseline, week 1, and months 1, 2, 3, 6, 9, and 12|Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, had at least 1 postbaseline measurement, and with available data at each time point.|||percent change||Standard Deviation|Mean
2616215|NCT01992159|Secondary|Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP)||Baseline, week 1, and months 1, 2, 3, 6, 9, and 12|Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, had at least 1 postbaseline measurement and with available data at each time point.|||percent change||Standard Deviation|Mean
2616216|NCT01992159|Secondary|Percent Change From Baseline to 12 Months in Bone Mineral Density at the Femoral Neck|Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.|Baseline and 12 months|Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, and had at least 1 postbaseline measurement.|||percent change||95% Confidence Interval|Least Squares Mean
2616217|NCT01992159|Secondary|Percent Change From Baseline to 6 Months in Bone Mineral Density at the Femoral Neck|Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.|Baseline and 6 months|Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, and had at least 1 postbaseline measurement.|||percent change||95% Confidence Interval|Least Squares Mean
2616390|NCT01990768|Secondary|Number of Participants With Myocardial Infarction (MI)|Diagnosis of an acute myocardial infarction|From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)|Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.|||Participants|||Count of Participants
2616218|NCT01992159|Secondary|Percent Change From Baseline to 12 Months in Bone Mineral Density at the Total Hip|Bone density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.|Baseline and 12 months|Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, and had at least 1 postbaseline measurement.|||percent change||95% Confidence Interval|Least Squares Mean
2616219|NCT01992159|Secondary|Percent Change From Baseline at 6 Months in Bone Mineral Density at the Total Hip|Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.|Baseline and 6 months|Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, and had at least 1 postbaseline measurement.|||percent change||95% Confidence Interval|Least Squares Mean
2616220|NCT01992159|Secondary|Percent Change From Baseline at 6 Months in Bone Mineral Density at the Lumbar Spine|Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.|Baseline and 6 months|Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, and had at least 1 postbaseline measurement.|||percent change||95% Confidence Interval|Least Squares Mean
2616221|NCT01992159|Primary|Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine|Bone mineral density was measured using dual-energy X-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging reader.|Baseline and 12 months|Randomized participants who received at least 10 doses of the assigned randomized treatment, never received any dose of incorrect treatment, had no missing baseline values, and had at least 1 postbaseline measurement (primary efficacy subset).|||percent change||95% Confidence Interval|Least Squares Mean
2616222|NCT01992107|Secondary|Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group|Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting unsolicited AEs (day 1 to 22 for Previously vaccinated and day 1 to day 50 for Not previously vaccinated subjects), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 for Previously vaccinated and day 1 to day 210 for Not previously vaccinated subjects) after receiving one or two doses of either QIVc, TIV1c or TIV2c. For A/H1N1, A/H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c.|Day 1 to 210 post vaccination|Analysis was done on unsolicited safety data set i.e. all subjects in the exposed set with unsolicited adverse event data|||Subjects|||Number
2616223|NCT01992107|Secondary|Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata|Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting solicited local and systemic reactions, day 1 to 7 after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c.For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c.|Day 1 to 7 after last vaccination|Analysis was done on solicited safety data set i.e. all subjects in the exposed set with solicited adverse event data|||Subjects|||Number
2616224|NCT01992107|Secondary|Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc or TIV2c|"Immunogenicity of QIVc to comparator TIV2c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks after last vaccination with QIVc or TIV2c.~Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody does not exceed the margin of 0 points"|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS population|||percentages of subjects||95% Confidence Interval|Number
2616225|NCT01992107|Secondary|GMT in Subjects After Receiving One or Two Doses of Either QIVc,TIV2c Against B1 Strain|"Immunogenicity of QIVc to comparator TIV2c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses of either QIVc or TIV2c.~Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1"|Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS population|||Titers||95% Confidence Interval|Geometric Mean
2616226|NCT01992107|Secondary|Percentages of Subjects Achieving Seroconversion Against B2 Strain After One or Two Doses of Either QIVc or TIV1c|"Immunogenicity of QIVc to comparator TIV1c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks after last vaccination with QIVc or TIV1c.~Superiority criterion was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 0 points"|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS population|||percentages of subjects||95% Confidence Interval|Number
2616227|NCT01992107|Secondary|GMT in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c Against B2 Strain|"Immunogenicity of QIVc to comparator TIV1c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses of either QIVc or TIV1c.~Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody did not exceed the superiority margin of 1"|Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS population|||Titers||95% Confidence Interval|Geometric Mean
2616391|NCT01990768|Secondary|Number of Participants With Cerebral Ischemic Event|Diagnosis of cerebral ischemic event|From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)|Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.|||Participants|||Count of Participants
2616228|NCT01992107|Secondary|Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age|Immunogenicity was measured in subjects (Previously vaccinated and Not previously vaccinated) as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c .For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The CHMP criterion for GMR in adult population is >2.5|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS immunogenicity set|||Ratios||95% Confidence Interval|Geometric Mean
2616229|NCT01992107|Secondary|Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years|Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The Committee for Medicinal Products for Human Use (CHMP) criterion for an adult population was that the percentage of subjects achieving an HI titer ≥1:40 is >70%|Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS immunogenicity set|||percentages of subjects||95% Confidence Interval|Number
2616230|NCT01992107|Secondary|Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years|Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS immunogenicity set|||percentages of subjects||95% Confidence Interval|Number
2616231|NCT01992107|Secondary|Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years|"Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c.~The CBER criterion for adult population was that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%"|Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on FAS immunogenicity set (FAS) i.e. all subjects in the enrolled set who received at least one study vaccination and provided immunogenicity data at day 22 (day 50 for not previously vaccinated subjects)|||percentages of subjects||95% Confidence Interval|Number
2616232|NCT01992107|Secondary|Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years|"Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.~The Center for Biologics Evaluation, Research, and Review (CBER) criterion for an adult population is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%"|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on Full Analysis Set (FAS) immunogenicity set i.e. all subjects in the enrolled set who received ▫ Received at least one study vaccination and provided immunogenicity data at day 1 and day 22 (day 50 for not previously vaccinated subjects)|||percentages of subjects||95% Confidence Interval|Number
2616233|NCT01992107|Primary|Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c|Immunogenicity of QIVc to comparator TIVc (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase (at least a 4-fold increase in HI titer in subjects seropositive at baseline [i.e., HI titer ≥1:10 at Day 1] ) in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.|Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on PP population|||percentages of subjects||95% Confidence Interval|Number
2616244|NCT01992094|Secondary|4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts|Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70% and that for the ≥ 65 years age group should meet or exceed 60%|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set.|||percentages of subjects||95% Confidence Interval|Number
2616417|NCT01990612|Secondary|Maternal Postpartum Length of Hospital Stay||delivery through hospital discharge||||Participants|||Count of Participants
2616234|NCT01992107|Primary|Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c|"Immunogenicity of QIVc to comparator TIV1c (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by hemagglutination inhibition (HI) assay, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c.~Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5."|Day 1,Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)|Analysis was done on Per Protocol (PP) Population i.e. all subjects in the Full Analysis Set (FAS) efficacy/immunogenicity population correctly received the vaccine, had no major protocol deviations leading to exclusion as defined prior to unblinding/analysis and are not excluded due to other reasons defined prior to unblinding or analysis|||Titers||95% Confidence Interval|Geometric Mean
2616235|NCT01992094|Secondary|13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group|Safety was assessed in terms of number (%) of subjects reporting unsolicited AEs (day 1 to 22 after vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 post vaccination) after receiving one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)|Day 1 to 181 post vaccination|Analysis was done on unsolicited safety data set i.e. all subjects in the exposed set with unsolicited adverse event data|||Subjects|||Number
2616236|NCT01992094|Secondary|12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group|Safety was assessed in terms of number (%) of subjects reporting solicited local and systemic reactions, day 1 to 7 after vaccination with one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)|Day 1 to 7 post vaccination|Analysis was done on solicited safety data set i.e. all subjects in the exposed set with solicited adverse event data|||Subjects|||Number
2616237|NCT01992094|Secondary|11.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV2c Against B1 Strain|Immunogenicity of QIVc to TIV2c in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks (day 22) after vaccination with QIVc or TIV2c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points|Three weeks post vaccination (Day 22)|Analysis was done on FAS population|||percentages of subjects||95% Confidence Interval|Number
2616238|NCT01992094|Secondary|10.GMT in Subjects After Receiving One Dose of Either QIVc, TIV2c Against B1 Strain|"Immunogenicity of QIVc to TIV2c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV2c.~Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1"|Three weeks post vaccination (Day 22)|Analysis was done on FAS population|||Titers||95% Confidence Interval|Geometric Mean
2616239|NCT01992094|Secondary|9.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c Against B2 Strain|Immunogenicity of QIVc to TIV1c was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks (day 22) after vaccination with QIVc or TIV1c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points|Three weeks post vaccination (Day 22)|Analysis was done on FAS population|||percentages of subjects||95% Confidence Interval|Number
2616240|NCT01992094|Secondary|8.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c Against B2 Strain|"Immunogenicity of QIVc to TIV1c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV1c.~Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1."|Three weeks post vaccination (Day 22)|Analysis was done on FAS population|||Titers||95% Confidence Interval|Geometric Mean
2616241|NCT01992094|Secondary|7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts|Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c and TIV2c The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving an HI titer ≥1:40 is >70% and that for ≥ 61 years age group is >60%|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set.|||percentages of subjects||95% Confidence Interval|Number
2616242|NCT01992094|Secondary|6. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts|Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving seroconversion or significant increase in HI titer is >40% and that for ≥ 61 years age group is >30%|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set.|||percentages of subjects||95% Confidence Interval|Number
2616243|NCT01992094|Secondary|5.Geometric Mean Ratios (GMR) in Subjects After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts|Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of post-vaccination to pre-vaccination HI GMTs, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Committee for Medicinal Products for Human Use (CHMP) criterion for 18 to ≤60 years age group is >2.5 and that for ≥ 61 years age group is >2.0|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set.|||Ratio||95% Confidence Interval|Geometric Mean
2616245|NCT01992094|Secondary|3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts|Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against each vaccine strains, three weeks (day 22) after vaccination with ether QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% and that for the ≥ 65 years age group should meet or exceed 30%|Three weeks post vaccination (Day 22)|Analysis was done on FAS immunogenicity set i.e. all subjects in the enrolled set who receive the study vaccination and provide immunogenicity data at visit 1 and visit 2|||percentages of subjects||95% Confidence Interval|Number
2616246|NCT01992094|Primary|2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c|Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with one dose of either QIVc,TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer|Three weeks post vaccination (Day 22)|Analysis was done on PP population|||percentage of subjects||95% Confidence Interval|Number
2616247|NCT01992094|Primary|1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c|"Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of GMT in subjects measured by hemagglutination inhibition (HI) assay, three weeks after vaccination with one dose of either QIVc or TIV1c and TIV2c.~Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5."|Three weeks post vaccination (Day 22)|Analysis was done on Per Protocol (PP) Population i.e. all subjects in the Full Analysis Set (FAS) efficacy/immunogenicity population correctly receive the vaccine, have no major protocol deviations leading to exclusion as defined prior to unblinding/analysis and are not excluded due to other reasons defined prior to unblinding or analysis|||Titer||95% Confidence Interval|Geometric Mean
2616248|NCT01992016|Primary|Number of Participants With Increase in SUV Uptake|"Number of participants who had increased SUV uptake, as defined by any of the following:~SUVmax increase of 30% with a 2 unit absolute change.~SUVmean increase of 30% with a 0.75 unit absolute change.~SUVmean increase of 20% with a 1 unit absolute change."|Within 1 week after completion of ranolazine treatment|This study was closed to accrual early. Due to small numbers, no statistical or firm conclusions can be made on the basis of such small numbers.|||Participants|||Count of Participants
2616249|NCT01991990|Primary|Absolute Median Fluorescence Intensities of Neutrophil Adhesion Molecules|Neutrophil surface receptor expression may be used to characterize the activation status of neutrophils. Fresh (0 min), PBS control (30 min) and fMLP-stimulated (30 min) PMNs (5 × 10^6 PMNs/mL) were fixed with CellFIX, and 90 μL transferred to each tube containing antibody mixture (2 μL cluster of differentiation [CD] 11b-brilliant violet (BV) 421, 2 μL CD16-FITC, 5 μL CD62L-allophycocyanin (APC) and 5 μL CD162-phycoerythrin [PE]) or isotype control mixture of equivalent volumes. After 30 minutes of incubation on ice and in the dark, cold PBS was added to stop further reaction. Surface marker expressions were quantified by flow cytometry.|Day 4|Safety analysis population|||median fluoresence intensity||Standard Error|Mean
2616250|NCT01991990|Primary|Neutrophil Morphology: Change From Baseline to the Nadir (Day 4) in the Percentage of Neutrophils With Shape Change Measured by Microscopic Morphology|Neutrophil shape change is an indicator of the chemotactic ability of neutrophils to respond to and migrate to sites of inflammation. For determination of neutrophil shape change, fresh (0 min control), PBS control (30 min control) and fMLP-stimulated (30 min fMLP) PMNs (at 5 × 10^6 PMNs/ mL) were fixed with CellFIX, 90 μL transferred to each sample tube, and cold PBS added to stop further reaction. Shape change was assessed by microscopy with neutrophils classified as shape-changed if they contained > 1 cell surface bleb or irregularity and change from baseline in percentage of neutrophil with shape change on Day 4 was reported.|Baseline, Day 4|Safety analysis population|||percentage of shape changed neutrophils||Standard Error|Mean
2616251|NCT01991990|Primary|Neutrophil Morphology: Change From Baseline to the Nadir (Day 4) in the Percentage of Neutrophils With Shape Change Measured by Flow Cytometry (FSC-High Cells)|Neutrophil shape change is an indicator of the chemotactic ability of neutrophils to respond to and migrate to sites of inflammation. For determination of neutrophil shape change, fresh (0 min control), PBS control (30 min control) and fMLP-stimulated (30 min fMLP) PMNs (at 5 × 10^6 PMNs/ mL) were fixed with CellFIX, 90 μL transferred to each sample tube, and cold PBS added to stop further reaction. Shape change was assessed by measuring FSC on flow cytometry. Change from baseline in the percentage of neutrophils with shape change on Day 4 was reported.|Baseline, Day 4|Safety analysis population|||percentage of shape changed neutrophils||Standard Error|Mean
2616252|NCT01991990|Primary|Neutrophil Morphology: Change From Baseline to Nadir in the Number of Neutrophils With Shape Change Measured Using Flow Cytometry|Neutrophil shape change is an indicator of the chemotactic ability of neutrophils to respond to and migrate to sites of inflammation. For determination of neutrophil shape change, fresh (0 min control), phosphate-buffered saline (PBS) control (30 min control) and formyl-methionyl-leucyl-phenylalanine (fMLP)-stimulated (30 min fMLP) PMNs (at 5 × 10^6 PMNs/ milliliter [mL]) were fixed with CellFIX (organic solvent used as fixative for adherent cells), 90 microliters (μL) transferred to each sample tube, and cold PBS added to stop further reaction. Shape change was assessed by measuring forward scatter (FSC) on flow cytometry. Change from baseline in the number of neutrophils with shape change on Day 4 was reported.|Baseline, Day 4|Safety analysis population|||neutrophils with shape change||Standard Error|Mean
2616418|NCT01990612|Secondary|Number of Hours on the Labor and Delivery Unit|Median duration of stay in labor and delivery unit|Hours from admission to L&D to discharge from L&D|Excludes 7 women who delivered before admission to the labor and delivery unit. Data are missing for 2 women.|||hours||Inter-Quartile Range|Median
2616253|NCT01991990|Primary|Neutrophil Survival: Change From Baseline to the Nadir in the Percentage of Apoptotic Neutrophils as Measured by Flow Cytometry|Ageing neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of Annexin V (AV) to bind exposed phosphatidylserine. Propidium Iodide (PI) is normally membrane-impermeable but enters cells in late apoptosis when their plasma membrane becomes leaky. Neutrophils constitutively undergo apoptosis when cultured ex vivo, and this can be delayed by the addition of agents such as granulocyte-macrophage colony-stimulating factor (GM-CSF) or TNFα. Apoptosis was assessed by flow cytometry with fluorescein isocyanate-labeled recombinant human AV (AV-FITC) and PI staining and the change from baseline in the percentage of apoptotic neutrophils on Day 4 measured by flow cytometry is reported.|Baseline, Day 4|Safety analysis population|||percentage of apoptotic neutrophils||Standard Error|Mean
2616254|NCT01991990|Primary|Neutrophil Survival: Change From Baseline to the Nadir (Day 4) in the Percentage of Apoptotic Neutrophils as Measured by Microscopic Morphology|Neutrophil apoptosis was measured using microscopy method with slides stained with Diff-Quik (modified Wright Giemsa stain) and morphology examined under oil immersion light microscopy with 100 times magnification. Neutrophils constitutively undergo apoptosis when cultured ex vivo, and this can be delayed by the addition of agents such as granulocyte-macrophage colony-stimulating factor (GM-CSF) or TNFα. Apoptotic neutrophils were characterized with dark and pyknotic nuclei compared to the viable neutrophils. Change from baseline in the percentage of apoptotic neutrophils on Day 4 measured by microscopy is reported.|Baseline, Day 4|Safety analysis population|||percentage of apoptotic neutrophils||Standard Error|Mean
2616255|NCT01991990|Primary|Neutrophil Respiratory Burst: Change From Baseline to Nadir (Day 4) in the Production of Reactive Oxygen Species as Measured by Chemiluminescence (Relative Light Units - Absolute)|Neutrophils generate a respiratory burst using reactive oxygen species (ROS) to kill invading pathogens. When luminol is used as a substrate for ROS, a chemical reaction is produced resulting in photon emission (chemiluminescence) in primed and unprimed neutrophils following formyl-methionyl-leucyl-phenylalanine (fMLP) stimulation which is quantifiable. fMLP stimulation of the respiratory burst is mediated through activation of nicotinamide adenine dinucleotide phosphate (NADPH) oxidase in primed neutrophils. The maximal fMLP response is observed in primed neutrophils and is an ex vivo measure of the capacity of neutrophils to respond to pathogenic stimuli. In the current experiments, neutrophils were primed with tumor necrosis factor alpha (TNFα). Light emission was recorded on a luminometer. Absolute change from baseline in the production of ROS on Day 4 was reported.|Baseline, Day 4|Safety analysis population|||relative light units||Standard Error|Mean
2616256|NCT01991990|Primary|Neutrophil Phagocytosis: Change From Baseline to Nadir (Day 4) in Median Fluorescence Intensity (MFI) of eFluor670+ Neutrophils|Neutrophil phagocytosis was assessed by flow cytometry using heat-killed Staphylococcal pneumonia bacteria labeled with eFluor670. Phagocytosis was quantified by measuring the eFluor670 fluorescence from neutrophils containing phagocytosed bacteria. Experiments were performed using neutrophils (PMN) only, PMN plus S. pneumonia at 4˚C (to control for non-specific bacterial adherence to PMN cell surface), and PMN plus S. pneumonia at 37˚C. Change from baseline in the eFluor670+ MFI was calculated on Day 4.|Baseline, Day 4|Safety analysis population|||median fluoresence intensity||Standard Error|Mean
2616257|NCT01991990|Primary|Neutrophil Phagocytosis: Change From Baseline to Nadir (Day 4) in the Percentage of eFluor670-Positive (eFluoro670+) Neutrophils|Neutrophil phagocytosis was assessed by flow cytometry using heat-killed Staphylococcal pneumonia (S.pneumonia) bacteria labeled with eFluor670. Phagocytosis was quantified by measuring the eFluor670 fluorescence from neutrophils containing phagocytosed bacteria. Experiments were performed using neutrophils (PMN) only, PMN plus S. pneumonia at 4 degrees(˚) centigrade (C) (to control for non-specific bacterial adherence to PMN cell surface), and PMN plus S. pneumonia at 37˚C. Change from baseline in the percentage of eFluor670+ neutrophils was calculated on Day 4.|Baseline, Day 4|Safety analysis population.|||percentage of eFlouro+ neutrophils||Standard Error|Mean
2616258|NCT01991990|Primary|Neutrophil Redistribution Analysis on Day 10|On Day 4 participants had neutrophils isolated from 100 mL of ACD-anti-coagulated autologous venous blood and labeled with up to 2.5 MBq 111In-tropolonate before being reinjected. Participants rested for 45 min post-injection to allow for neutrophil equilibrium between the circulating and marginating neutrophil pools. Whole-body profiling was performed in a heavily shielded dedicated whole-body counter with 2 highly sensitive scintillation detectors with the recorded counts corrected for the physical decay of 111In to allow measurement of the effect of TCZ on the normal redistribution pattern of neutrophils and assessment of margination of neutrophils in the presence of TCZ. Distribution of radiolabelled neutrophils and peak counts, on Day 10 (6 days post re-injection) in liver/spleen and pelvic bone marrow were decay corrected and expressed as percentages of Day 4 (45 minutes post re-injection).|Day 10|Safety analysis population. One participant in the PMN-high group was excluded due to external contamination affecting profiling data.|||percentage of Day 4 counts||Standard Error|Mean
2616259|NCT01991990|Primary|Neutrophil Redistribution Analysis on Day 5|On Day 4 participants had neutrophils isolated from 100 mL of ACD-anti-coagulated autologous venous blood and labeled with up to 2.5 MBq 111In-tropolonate before being reinjected. Participants rested for 45 min post-injection to allow for neutrophil equilibrium between the circulating and marginating neutrophil pools. Whole-body profiling was performed in a heavily shielded dedicated whole-body counter with 2 highly sensitive scintillation detectors with the recorded counts corrected for the physical decay of 111In to allow measurement of the effect of TCZ on the normal redistribution pattern of neutrophils and assessment of margination of neutrophils in the presence of TCZ. Distribution of radiolabelled neutrophils and peak counts, on Day 5 (24-hours post re-injection) in liver/spleen and pelvic bone marrow were decay corrected and expressed as percentages of Day 4 (45 minutes post re-injection).|Day 5|Safety analysis population. One participant in the PMN-high group was excluded due to external contamination affecting profiling data.|||percentage of Day 4 counts||Standard Error|Mean
2616273|NCT01991977|Secondary|Progression Free Survival|The proportion of successes will be estimated by the number of successes divided by the total number of grade III evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. The distributions of progression free survival times and comparisons between these two groups will be estimated using the method of Kaplan-Meier.|Time from registration to the earliest date of documenting disease progression, assessed up to 5 years||2023-12-31|12/2023||||
2616260|NCT01991990|Primary|Neutrophil Redistribution Analysis on Day 4 (Neutrophil Nadir)|On Day 4 participants had neutrophils isolated from 100 milliliters (mL) of acid-citrate dextrose (ACD)-anti-coagulated autologous venous blood and labeled in autologous plasma with up to 2.5 megaBecquerel (MBq) 111 Indium (111In)-tropolonate before being reinjected. Participants rested for 45 minutes (min) post-injection to allow for neutrophil equilibrium between the circulating and marginating neutrophil pools. Whole-body profiling was performed in a heavily shielded dedicated whole-body counter with 2 highly sensitive scintillation detectors with the recorded counts corrected for the physical decay of 111In to allow measurement of the effect of TCZ on the normal redistribution pattern of neutrophils and assessment of margination of neutrophils in the presence of TCZ. Distribution of radiolabelled neutrophils on Day 4 (45 min post re-injection) in the blood, liver/spleen and pelvic bone marrow, expressed as percentages of total body counts (TBCs).|Day 4|Safety analysis population: Includes all the participants who received the single dose of randomized study medication. One participant in the polymorphonuclear leukocyte (PMN)-high group was excluded due to external contamination affecting profiling data.|||percentage of total body count||Standard Error|Mean
2616261|NCT01991977|Other Pre-specified|Timing of Accurate Identification of Progression Defined by 18F- DOPA Positron Emission Tomography, Perfusion Magnetic Resonance Imaging and Conventional Magnetic Resonance Imaging for Grade III Glioma Patients|Progression identification timing will be compared using Kaplan-Meier methods and paired t-tests to determine if differences exist between the modalities. An exploratory analysis of diffusion tensor imaging for detecting invasive non-enhancing tumor recurrence will also be performed.|Up to 5 years|||||||
2616262|NCT01991977|Other Pre-specified|Timing of Accurate Identification of Progression Defined by 18F- DOPA Positron Emission Tomography, Perfusion Magnetic Resonance Imaging and Conventional Magnetic Resonance Imaging for Grade IV Glioma Patients|The progression identification timing will be compared by calculating the percentage of time each modality was earlier than conventional magnetic resonance imaging. With a sample size of 72, if the observed percentage earlier than conventional magnetic resonance imaging is 30% for either modality, a two-sided 95% confidence interval for a single proportion using the large sample normal approximation will be +/- 10.6%. Progression identification timing will also be compared using Kaplan-Meier methods and paired t-tests to determine if differences exist between the modalities.|Up to 5 years|||||||
2616263|NCT01991977|Other Pre-specified|Radiation Therapy Treatment Volumes Defined by Magnetic Resonance Imaging Only or Defined With Both Positron Emission Tomography and Magnetic Resonance Imaging Information for Grade IV Glioma Patients|Paired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between treatment volumes defined by magnetic resonance imaging only and treatment volumes defined with both positron emission tomography and magnetic resonance imaging information. The analysis of volumes from 72 grade IV patients will have 90% power to detect differences in volumes with an effect size of 0.39 using a paired t-test with a 0.05 two-sided significance level. Alternate metrics for comparison will also be assessed, including spatial overlap, distan|Up to 5 years|||||||
2616264|NCT01991977|Other Pre-specified|Radiation Therapy Treatment Volumes Defined by Magnetic Resonance Imaging Only and Defined With Both Positron Emission Tomography and Magnetic Resonance Imaging Information for Grade III Glioma Patients|Paired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between treatment volumes defined by magnetic resonance imaging only and treatment volumes defined with both positron emission tomography and magnetic resonance imaging information.|Up to 5 years|||||||
2616265|NCT01991977|Other Pre-specified|Predictive Capabilities of 18F-DOPA Positron Emission Tomography, Perfusion Magnetic Resonance Imaging, and Diffusion Tensor Imaging for Localization of Recurrences|Compared by identifying the recurrence volume with each modality and correlating with identification of aggressive disease in the pre-radiation therapy planning images.|Up to 5 years|||||||
2616266|NCT01991977|Other Pre-specified|Patterns of Failure After Radiation Therapy Targeting Volumes by 18F-DOPA Positron Emission Tomography and Conventional Magnetic Resonance Imaging|Chi-square tests of proportions will be used to test for differences in the proportions of patients with central, in-field, marginal, or distant failures between the patients on this study and historical controls.|Up to 5 years|||||||
2616267|NCT01991977|Other Pre-specified|Magnetic Resonance Imaging-only Defined Volumes and the Volumes Defined With the Combination of Magnetic Resonance and Positron Emission Tomography Planning|Paired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between treatment volumes defined by magnetic resonance imaging only and treatment volumes defined with both positron emission tomography and magnetic resonance imaging information. The analysis of volumes from 72 grade IV patients will have 90% power to detect differences in volumes with an effect size of 0.39 using a paired t-test with a 0.05 two-sided significance level. Alternate metrics for comparison will also be assessed, including spatial overlap, distanc|Up to 5 years|||||||
2616268|NCT01991977|Other Pre-specified|Intra-observer Variability With or Without the Addition of 18F-DOPA Positron Emission Tomography Uptake for Radiotherapy Target Volume Delineation|The concordance correlation coefficient will be used to measure agreement between volumes generated with each method, as well as to evaluate inter-observer variability, where variability associated with magnetic resonance imaging will serve as the standard for comparison.|Up to 5 years|||||||
2616269|NCT01991977|Other Pre-specified|Inter-observer Variability With or Without the Addition of 18F-DOPA Positron Emission Tomography Uptake for Radiotherapy Target Volume Delineation|The concordance correlation coefficient will be used to measure agreement between volumes generated with each method, as well as to evaluate inter-observer variability, where variability associated with magnetic resonance imaging will serve as the standard for comparison.|Up to 5 years|||||||
2616270|NCT01991977|Secondary|Rate of Late Treatment-related Toxicities Using the Radiation Therapy Oncology Group/European Organization for Research and the Treatment of Cancer Toxicity Criteria||Up to 5 years||2023-12-31|12/2023||||
2616271|NCT01991977|Secondary|Rate of Acute Treatment-related Toxicities Graded Using Common Terminology Criteria for Adverse Events Version 4.0||Up to 5 years||2023-12-31|12/2023||||
2616272|NCT01991977|Secondary|Quality of Life Evaluated With the MD Anderson Symptom Inventory Brain Tumor Module and Mini-Mental Status Exam Questionnaires|Analysis will include change percent from baseline using t-tests and generalized linear models to test for changes at each time point and non-zero slope, respectively.|Up to 5 years||2023-12-31|12/2023||||
2616275|NCT01991977|Primary|Proportion of Grade IV MGMT Un-methylated Patients That Experience Confirmed-progression-free Survival at 6 Months (CPFS6)|"The proportion of Grade IV MGMT un-methylated patients that experience confirmed-progression-free survival at 6 months (CPFS6). Progression is defined by any of the following:~≥25% increase in the sum of products of perpendicular diameters of enhancing lesions compared to the smallest tumor measurement obtained either at baseline or best response, on stable or increasing doses of corticosteroids~Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids compared to baseline scan or best response following initiation of therapy, not due to co-morbid events~Any new lesion~Clear clinical deterioration not attributable to other causes apart from the tumor or changes in corticosteroid dose.~Failure to return for evaluation due to death or deteriorating condition~Clear progression of non-measurable disease"|Time from registration to the confirmed disease progression, assessed at 6 months|All Grade IV MGMT un-methylated patients meeting eligibility criteria who have signed a consent form and who have begun treatment with 18F-DOPA PET image-guided dose escalation RT will be evaluable for the endpoint.|||proportion of participants||95% Confidence Interval|Number
2616276|NCT01991860|Secondary|"Number of Participants With Total Response"|Total response is defined as no occurrence of vomiting/retching, no nausea score ≥ 1 and no use of rescue medication.|24 hours after the end of surgery||||Participants|||Count of Participants
2616277|NCT01991860|Secondary|The Number of Participants With no Significant Nausea|"Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. No significant nausea means no score ≥ 4."|24 hours after the end of surgery||||Participants|||Count of Participants
2616278|NCT01991860|Secondary|The Number of Participants With no Emesis, no Significant Nausea and no Use of Rescue Medication|No occurrence of vomiting/retching, no nausea score ≥ 4 on verbal response scale (where 0=no nausea at all and 10=the worst nausea imaginable) and no use of rescue medication.|24 hours after the end of surgery||||Participants|||Count of Participants
2616279|NCT01991860|Secondary|Number of Participants With no Use of Rescue Medication|Any agent given in the post-operative period with the intention of providing anti-emetic rescue was counted as rescue anti-emetic medication for the purposes of efficacy determination, even if it did not achieve control of emesis or was given incorrectly (e.g., wrong dosage or route). Any agent given in the post-operative period which would be expected, by virtue of its pharmacology, dosage and route, to exert a clinically meaningful anti-emetic effect was considered as rescue anti-emetic medication, even if administered inadvertently or without the intention of providing rescue.|24 hours after end of surgery||||Participants|||Count of Participants
2616280|NCT01991860|Secondary|Number of Participants With no Emesis|Emesis is defined as vomiting (production of even the smallest amount of stomach contents) or retching (muscular movements of vomiting but without expulsion of stomach contents, usually because of an empty stomach)|24 hours after end of surgery||||Participants|||Count of Participants
2616281|NCT01991860|Secondary|Number of Participants With no Nausea.|"Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. No nausea means no score ≥ 1."|24 hours after end of surgery||||Participants|||Count of Participants
2616282|NCT01991860|Primary|Number of Participants With Complete Response|The primary efficacy analysis was a comparison of the incidence of Complete Response, defined as no emesis (vomiting or retching) and no use of rescue medication in the 24 hours after the end of surgery, between the active group and the placebo group using Pearson χ2 test with Yates's continuity correction, and with a two-sided significance level of 5%.|24 hours after the end of surgery||||Participants|||Count of Participants
2616283|NCT01991821|Secondary|Use of Rescue Medication||24 hours after end of surgery||||Participants|||Count of Participants
2616284|NCT01991821|Secondary|Incidence of Significant Nausea|Count of participants with nausea score ≥ 4 on 0-10 verbal response scale|24 hours after end of surgery||||Participants|||Count of Participants
2616285|NCT01991821|Secondary|Incidence of Nausea|Count of patients experiencing an episode of nausea scored ≥ 1 of 0-10 verbal response scale during the 24 hours period after the completion of surgery|24 hours after end of surgery|mITT|||Participants|||Count of Participants
2616286|NCT01991821|Secondary|Incidence of Emesis (Vomiting/Retching)|An assessment of a participant experiencing an episode of emesis (vomiting/ retching) or received anti-emetic rescue medication during the 24hours after the completion of the surgery|24 hours after end of surgeryry||||Participants|||Count of Participants
2616287|NCT01991821|Secondary|Total Response (no Emesis, Nausea or Rescue Medication)||24 hrs after end of surgery|mITT|||Participants|||Count of Participants
2616288|NCT01991821|Secondary|Complete Response (no Emesis or Rescue Medication)||24 hrs after end of surgery||||Participants|||Count of Participants
2616289|NCT01991821|Primary|Complete Response (no Emesis, Significant Nausea or Rescue Medication)|The primary efficacy analysis was a comparison of the incidence of Complete Response (absence of PONV1) in the 0-24-hour period after surgery, between the active treatment group and the placebo group using Pearson square test with Yates's continuity correction at a two-sided significance level of 5%.|24 hours after end of surgery||||Participants|||Count of Participants
2616290|NCT01991808|Primary|Number of Participants With Adverse Events||2 years||||Participants|||Count of Participants
2616291|NCT01991795|Other Pre-specified|Permanent Discontinuation of Study Medication Due to Any Bleeding Event|Participants with permanent discontinuation of study medication due to any bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and the date of last dose of study medication|From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.|The population was the safety analysis set, which included all patients who received at least 1 dose of randomised ticagrelor or placebo|||Number of participants with event|||Number
2616292|NCT01991795|Other Pre-specified|PLATO Major Bleeding Event|Participants with PLATO major bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication|From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.|The population was the safety analysis set, which included all patients who received at least 1 dose of randomised ticagrelor or placebo|||Number of participants with event|||Number
2616293|NCT01991795|Other Pre-specified|TIMI Major or Minor Bleeding Event|Participants with TIMI major or minor bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication|From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.|The population was the safety analysis set, which included all patients who received at least 1 dose of randomised ticagrelor or placebo|||Number of participants with event|||Number
2616294|NCT01991795|Other Pre-specified|TIMI Major Bleeding Event (Primary Safety Objective)|Participants with TIMI major bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication|From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.|The population was the safety analysis set, which included all patients who received at least 1 dose of randomised ticagrelor or placebo|||Number of participants with event|||Number
2616295|NCT01991795|Secondary|All-cause Death|Participants with all-cause death. If no event, censoring occurs at the earliest of PACD and last endpoint assessment date. Includes deaths based on publically available vital status data in patients who have withdrawn consent.|From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.|The population was the full analysis set, which included all randomised patients except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor.|||Number of participants with event|||Number
2616296|NCT01991795|Secondary|Ischaemic Stroke|Participants with ischaemic stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and death date.|From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.|The population was the full analysis set, which included all randomised patients except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor.|||Number of participants with event|||Number
2616297|NCT01991795|Secondary|MI|Participants with myocardial infarction. If no event, censoring occurs at the earliest of primary analysis censoring date (PACD), last endpoint assessment date and death date|From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.|The population was the full analysis set, which included all randomised patients except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor.|||Number of participants with event|||Number
2616298|NCT01991795|Secondary|CV Death|Participants with Cardiovascular (CV) death. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date.|From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.|The population was the full analysis set, which included all randomised patients except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor.|||Number of participants with event|||Number
2616299|NCT01991795|Primary|Composite of Cardiovascular (CV) Death, MI or Stroke|Participants with Cardiovascular (CV) death, myocardial infarction (MI) or stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date.|From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.|The population was the full analysis set, which included all randomised patients except the 51 patients who were randomised to study drug at a site prematurely closed by sponsor.|||Number of participants with event|||Number
2616300|NCT01991743|Secondary|Abdominal Relaxation|Obstetrician rating of participants abdominal relaxation (Visual analog score: VAS score= 0 no relaxation- complete relaxation 100)|<20 minutes||||units on a scale||Inter-Quartile Range|Median
2616301|NCT01991743|Secondary|Pain Score During the Procedure|pain score during the procedure (Visual Analog Score: VAS=0 no pain -100 worst pain imaginable, scale)|< 20 minutes||||units on a scale||Inter-Quartile Range|Median
2616302|NCT01991743|Secondary|Indication of Cesarean Delivery||To time of delivery||||Participants|||Count of Participants
2616303|NCT01991743|Secondary|Mode of Delivery||To time of delivery||||count of participants|||Number
2616304|NCT01991743|Primary|Success Rate of External Cephalic Version|Rates of successful version evaluated among the 4 dose groups.|Completion of the procedure||||Participants|||Count of Participants
2616305|NCT01991548|Primary|User Acceptance of the New MiniMed 640G Insulin Pump and Guardian Link Transmitter|Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess subject acceptance of the MiniMed 640G, Guardian Link Transmitter, and the training materials. A response of 4 or greater will be considered positive on a Likert scale for training materials and product acceptance.|Four weeks of pump wear||||units on a scale||Standard Deviation|Mean
2616306|NCT01991522|Secondary|Retention of Clinical Skills|The Joint Advisory Group (JAG) Direct Observation of Procedural Skills (DOPS) tool is a tool to assess colonoscopic competency and includes ratings of the following domains: (i) assessment, consent and communication; (ii) safety and sedation; (iii) endoscopic skills during insertion and withdrawal; and, (iv) diagnostic and therapeutic ability. Scores range from 0-100, with higher scores representing higher colonoscopic competency. The tool will be used to assess participants during an integrated scenario. A change in these ratings before and after intervention is the secondary outcome.|4-6 weeks after intervention||||units on a scale||Standard Deviation|Mean
2616307|NCT01991522|Primary|Transfer of Skills to Clinical Colonoscopy|The Joint Advisory Group (JAG) Direct Observation of Procedural Skills (DOPS) tool is a tool to assess colonoscopic competency and includes ratings of the following domains: (i) assessment, consent and communication; (ii) safety and sedation; (iii) endoscopic skills during insertion and withdrawal; and, (iv) diagnostic and therapeutic ability. Scores range from 0-100, with higher scores representing higher colonoscopic competency. These were measured across two endoscopic procedures, performed consecutively within two weeks of completion of the course. Data from two procedures were used to limit the influence of spurious findings from single procedures.|less than 2 weeks||||units on a scale||Standard Deviation|Mean
2616419|NCT01990612|Secondary|Number Infants Admitted to NICU or Intermediate Care|Number infants admitted to intensive care unit (NICU) or intermediate care unit|delivery through hospital discharge||||Participants|||Count of Participants
2616420|NCT01990612|Secondary|Number of Infants With Neonatal Hypoglycemia|glucose < 35 mg/dl and requiring IV therapy|delivery through discharge||||Participants|||Count of Participants
2616308|NCT01991483|Secondary|Area Under the Plasma Concentration-Time Curve From 0 to 336 Hours AUC(0-336) During and Outside Dialysis|"Time frame for Cycle 2: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2d, 4d, 7d, 9d, 11d postdose;~Dialysis did not occur in cycle 1."|Cycle 1: Predose, end of infusion, 2hours, 4h, 2d, 4d, 7d, 9d, 11d postdose|All participants who received 300 mg LY2928057 or 600 mg LY2928057 during dialysis and non-dialysis day and had evaluable plasma values. Data were not collected in the 1000 mg LY2928057 arm.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2616309|NCT01991483|Secondary|Number of Participants With Anti-LY2928057 Antibodies||Baseline through 84 days|All participants who received at least one dose of study drug and had evaluable antibody values at baseline and post-baseline.|||participants|||Number
2616310|NCT01991483|Secondary|Pharmacokinetics: Area Under the Concentration Curve From Time Zero to Infinity (AUC[0-inf]) of LY2928057|"Time frame for Cycle 2: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2d, 4d, 7d, 9d, 11d postdose;~Time frame for Cycle 3: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2d, 4d, 7d, 9d, 11d, 14d postdose;"|Cycle 1: Predose, end of infusion, 2hours(h), 4h, 2d, 4d, 7d, 9d, 11d postdose|All participants who received at least one dose of LY2928057 and had evaluable plasma values.|||micrograms x hours/milliliter(µg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2616311|NCT01991483|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2928057|"Time frame for Cycle 2: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2 days (d), 4d, 7d, 9d, 11d postdose;~Time frame for Cycle 3: Predose, end of infusion, prior to end of dialysis or 2h, post dialysis or 4h, 2d, 4d, 7d, 9d, 11d, 14d postdose"|Cycle 1: Predose, end of infusion, 2hours(h), 4h, 2d, 4d, 7d, 9d, 11d postdose;|All participants who received at least one dose of LY2928057 and had evaluable plasma values.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2616312|NCT01991483|Secondary|Pharmacodynamics (PD): Maximum Change in Ferritin||Baseline through 6 weeks|All participants who received at least one dose of study drug and had evaluable ferritin values at baseline and post-baseline.|||micrograms/liter (ug/L)||Standard Deviation|Mean
2616313|NCT01991483|Secondary|Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Hemoglobin Concentration (MCHC)||Baseline through 6 weeks|All participants who received at least one dose of study drug and had evaluable MCHC values at baseline and post-baseline.|||millimoles/liter of iron (mml/L-Fe)||Standard Deviation|Mean
2616314|NCT01991483|Secondary|Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Hemoglobin (MCH)||Baseline through 6 weeks|All participants who received at least one dose of study drug and had evaluable MCH values at baseline and post-baseline.|||femtomoles of iron (fmol[Fe])||Standard Deviation|Mean
2616315|NCT01991483|Secondary|Pharmacodynamics (PD): Maximum Change in Mean Corpuscular Volume (MCV)||Baseline through 6 weeks|All participants who received at least one dose of study drug and had evaluable MCV values at baseline and post-baseline.|||femtoliters (fL)||Standard Deviation|Mean
2616316|NCT01991483|Secondary|Pharmacodynamics (PD): Maximum Change in Red Blood Cell (RBC) Count||Baseline through 6 weeks|All participants who received at least one dose of study drug and had evaluable RBC values at baseline and post-baseline.|||tera per liter (TI/L)||Standard Deviation|Mean
2616317|NCT01991483|Secondary|Pharmacodynamics (PD): Maximum Change in Reticulocyte Count||Baseline through 6 weeks|All participants who received at least one dose of study drug and had evaluable reticulocyte values at baseline and post-baseline.|||gigaparticles per liter (GI/L)||Standard Deviation|Mean
2616318|NCT01991483|Secondary|Pharmacodynamics (PD): Maximum Change in Concentration of Hemoglobin in Reticulocytes (CHr)||Baseline through 6 weeks|All participants who received at least one dose of study drug had evaluable CHr values at baseline and post-baseline.|||picograms (pg)||Standard Deviation|Mean
2616319|NCT01991483|Secondary|Pharmacodynamics (PD): Maximum Change in Transferrin Saturation (TSat)||Baseline through 6 weeks|All participants who received at least one dose of study drug and had evaluable TSat values at baseline and post-baseline.|||percentage change in TSat||Standard Deviation|Mean
2616320|NCT01991483|Secondary|Pharmacodynamics (PD): Geometric Mean Ratio of Serum Iron (Fe) Concentrations Relative to Baseline|Pharmacodynamics (PD): Geometric Mean Ratio of Serum Iron (Fe) Concentrations relative to baseline.|Baseline, 6 weeks|All participants who received at least one dose of study drug and had evaluable serum Fe values at baseline and post-baseline.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2616321|NCT01991483|Secondary|Pharmacodynamics (PD): Maximum Change in Hemoglobin||Baseline through 6 Weeks|All participants who received at least one dose of study drug had evaluable hemoglobin values at baseline and post-baseline.|||millimoles per liter of iron (mml/L-Fe)||Standard Deviation|Mean
2616322|NCT01991483|Primary|Change From Baseline in Hemoglobin at 6 Week Endpoint||Baseline, Day 42|All participants who received three doses of study drug, had pharmacodynamics assessment at Week 6, and/or received anti-anemic rescue therapy per protocol, regardless of whether they completed treatment.|||grams per deciliter (g/dL)||Standard Deviation|Mean
2616323|NCT01991483|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|A summary of other nonserious adverse events (AEs) and all SAEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline to Study Completion (up to Day 137)|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2616324|NCT01991470|Secondary|Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With GST3C Transmitter, Using One Additional Calibration During FST|Enlite 3 Sensor accuracy using GST3C transmitter used as a recorder compared to YSI or SMBG reference values, with one additional calibration during FST. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose.|7 Days|A total of 41 subjects did not have device data.|||percentage of difference||Standard Deviation|Mean
2616421|NCT01990612|Secondary|Number of Infants With Hyperbilirubinemia|Hyperbilirubinemia requiring phototherapy or exchange transfusion|delivery through discharge|Data were missing for 4 participants.|||Participants|||Count of Participants
2616422|NCT01990612|Secondary|Number of Infants Who Had Transfusion of Blood Products or Blood||delivery through hospital discharge||||Participants|||Count of Participants
2616325|NCT01991470|Secondary|Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System, Using One Additional Calibration During FST|Enlite 3 Sensor accuracy using Guardian Mobile System compared to YSI or SMBG reference values, with one additional calibration during FST. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose.|7 Days|A total of 34 subjects did not have device data.|||percentage of difference||Standard Deviation|Mean
2616326|NCT01991470|Secondary|Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump, Using One Additional Calibration During FST|Enlite Sensor accuracy relative to the YSI reference, using one additional calibration during FST. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days were pooled together for reporting purpose.|6 Days|A total of 34 subjects did not have device data.|||percentage of difference||Standard Deviation|Mean
2616327|NCT01991470|Secondary|Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump, Using One Additional Calibration During FST|Enlite Sensor accuracy relative to the YSI reference, using one additional calibration during FST. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days were pooled together for reporting purpose.|6 Days|A total of 32 subjects did not have device data.|||percentage of difference||Standard Deviation|Mean
2616328|NCT01991470|Secondary|Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump|Enlite Sensor accuracy relative to the YSI reference. Each subject wore two 530G pumps. The results for the higher serial number pump worn by each subject were arbitrarily selected and pooled across subjects for the secondary dataset. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days were pooled together for reporting purpose.|6 Days|All subjects wearing Enlite sensors with high serial number 530G pump. A total of 35 subjects did not have device data.|||percentage of difference||Standard Deviation|Mean
2616329|NCT01991470|Secondary|Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the GST3C Transmitter|Enlite 3 Sensor accuracy using GST3C transmitter used as a recorder compared to YSI or SMBG reference values. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose.|7 days|A total of 41 subjects did not have device data.|||percentage of difference||Standard Deviation|Mean
2616330|NCT01991470|Primary|Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System|Enlite 3 Sensor accuracy using Guardian Mobile System compared to YSI or SMBG (Self-Monitoring of Blood Glucose) reference values. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose.|7 days|a total of 25 subjects do not have device data|||percentage of difference||Standard Deviation|Mean
2616331|NCT01991470|Primary|Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump|Enlite Sensor accuracy relative to the YSI (Yellow Spring Instruments) reference. Each subject wore two 530G pumps. The results for the lower serial number pump worn by each subject were arbitrarily selected and pooled across subjects for the primary dataset. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days were pooled together for reporting purpose.|6 days|All subjects wearing Enlite sensor with lower serial number of 530G pump. A total of 30 subjects did not have device data.|||percentage of difference||Standard Deviation|Mean
2616332|NCT01991314|Secondary|Changes in Stress Levels|Perceived Stress Questionnaire (PSQ)-G is a 30-question measure of perceived stress giving total scores ranging between 30 (very unstressed) to 120 (very stressed).|Baseline (0 weeks) and end of trial (6 weeks)|Per protocol analysis|||units on a scale||Standard Error|Mean
2616333|NCT01991314|Secondary|Changes in Fatigue|Multidimensional Fatigue Inventory (MFI) is a 20 question-based scale with total scores ranging between 20 (very good) and 100 (very severe fatigue).|Baseline (0 weeks) and end of trial (6 weeks)|Per protocol|||units on a scale||Standard Error|Mean
2616334|NCT01991314|Secondary|Changes in Anxiety|Hospital Anxiety and Depression Score (HADS)-A, a scale of 7 questions score 0-3 each, so that total score 0 is good and 21 very severe anxiety.|Baseline (0 weeks) and end of trial (6 weeks)|Per protocol|||units on a scale||Standard Error|Mean
2616335|NCT01991314|Secondary|Change in Quality of Life Score|Short Inflammatory Bowel Disease Questionnaire (SIBDQ score), a health-related quality of life tool measuring physical, social, and emotional status (summated to produce a score of minimum 10 to maximum 70, representing poor to good quality of life, respectively). (Reporting of individual domain subscores is not valid).|Baseline (0 weeks) to end (6 weeks)|Per protocol analysis|||scores on a scale||Standard Error|Mean
2616336|NCT01991314|Secondary|Change in Disease Activity (Stool Calprotectin)|Difference between faecal calprotectin measured at baseline and at end of study|Baseline (0 weeks) and end of trial (6 weeks)|Per protocol analysis|||ug/g||Standard Error|Mean
2616337|NCT01991314|Secondary|Intolerance of Oral Iron|Numbers of patients who reported intolerance of oral iron (abdominal pain, nausea, vomiting, constipation, diarrhoea or headache)|Baseline (0 weeks) to end of trial (6 weeks)||||Participants|||Count of Participants
2616338|NCT01991314|Primary|Mean Change in Haemoglobin Concentration.|Change in serum Hb concentration in g/dl after 6 weeks of oral iron|Baseline (0 weeks) and end of trial (6 weeks)|Intention to treat population|||g/dl||Standard Error|Mean
2616339|NCT01990898|Primary|Symptom Improvement of Interstitial Cystitis|Number of participants with > 30% Improved Interstitial Cystitis Symptoms Index (ICSI) which is measured on a scale from 0 - 19 where the higher numbers are worse. No additional analyses have been done.|3 Months||||Participants|||Number
2616340|NCT01990859|Secondary|Percent of Participants With Best Overall Response (BOR) of Complete Response or Partial Response|Best Overall Response Rate (BORR) was defined as the total number of participants whose Best Overall Response (BOR) is Complete Response (CR) or Partial Response (PR) divided by the total number of treated participants (%). A two-sided, exact 95% Confidence Interval (Clopper and Pearson) for the BORR was calculated. Overall response (OR) was determined using modified World Health Organization (mWHO) criteria: Complete Response = complete disappearance of all index and non-index lesions, and no new lesions. Partial Response = decrease in index lesions of 50% or greater in a SPD relative to baseline, and no new lesions. BOR=an overall response of CR or PR at Week 12 or after Week 12.|Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)|All participants in the study who received at least one dose of treatment with ipilimumab were summarized.|||percentage of participants||95% Confidence Interval|Number
2616341|NCT01990859|Secondary|Number of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease as the Best Overall Response|Overall response (OR) was determined using modified World Health Organization (mWHO) criteria. Complete response (CR): complete disappearance of all index and non-index lesions, and no new lesions. Partial response (PR): decrease in index lesions of 50% or greater in a sum of the products of diameters (SPD) relative to baseline, and no new lesions. Stable Disease (SD): Does not meet criteria for CR or PR, in the absence of PD in index lesions and no change or any change with persistence of one or more non-index lesions, and no new lesions. Progressive Disease (PD): At least 25% increase in SPD relative to nadir in index lesions and unequivocal progression of non-index lesions, along with new lesions or no new lesions; or PD: new lesions with any response with index or non-index lesions. Not Evaluable: Response cannot be determined.|Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)|All participants in the study who received at least one dose of treatment with ipilimumab were summarized.|||participants|||Number
2616342|NCT01990859|Secondary|Number of Participants With Renal Laboratory Abnormalities|Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Renal parameter=Creatinine. The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28).|Baseline to 90 days post last dose, up to July 2014|All participants in the study who received at least one dose of treatment with ipilimumab and had laboratory data were summarized. Data included up to July 2014.|||participants|||Number
2616343|NCT01990859|Secondary|Number of Participants With Liver Function Laboratory Abnormalities|Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Liver Function parameters included: alanine aminotransaminase (ALT), aspartate aminotransferase (AST), Total Bilirubin, and Alkaline Phosphatase (Alk Phos). The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28).|Baseline to 90 days post last dose, up to July 2014|All participants in the study who received at least one dose of treatment with ipilimumab and had laboratory data were summarized. Data included up to July 2014.|||participants|||Number
2616344|NCT01990859|Secondary|Number of Participants With Hematology Laboratory Abnormalities|Abnormal laboratory results were reported after the induction period start and within 90 days after induction period end date. Induction Period was 1 dose every 3 weeks for 4 doses (12 weeks). Common Terminology Criteria (CTC) version 3.0 was used in this study; Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Hematology parameters included: White Blood Cell Count (WBC), Absolute Neutrophil Count, Platelet Count, Hemoglobin, and Lymphocyte Count (absolute). The most recent assessment on or before Day 1 of study medication was taken as baseline (in addition, baseline laboratory must have been collected no earlier than Day -28).|Baseline to 90 days post last dose, up to July 2014|All participants in the study who received at least one dose of treatment with ipilimumab and had laboratory data were summarized. Data included up to July 2014.|||participants|||Number
2616345|NCT01990859|Secondary|Number of Participants Who Died - All Treated Participants|Total number of deaths that occurred in all treated participants by study completion are reported.|Day 1 to 90 days post last dose, up to February 2015 (approximately 2 years)|All participants in the study who received at least one dose of treatment with ipilimumab were summarized.|||participants|||Number
2616346|NCT01990859|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) - All Treated Participants|AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related.|Day 1 to 90 Days after the last dose, up to July 2014|All participants in the study who received at least one dose of treatment with ipilimumab were summarized.|||participants|||Number
2616358|NCT01990794|Primary|Cobalt Serum Concentrations|The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing.|Before, during and after cobalt supplementation|Participants that completed three months of cobalt supplementation|||µg Co/L||Standard Deviation|Mean
2616423|NCT01990612|Secondary|Shoulder Dystocia||delivery||||Participants|||Count of Participants
2616424|NCT01990612|Secondary|Number of Infants With Cephalohematoma||delivery through hospital discharge||||Participants|||Count of Participants
2616347|NCT01990859|Primary|Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants|AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Primary endpoint (PE) includes results from Day 1 to 12 weeks after initial dose of last participant. Data evaluated at PE last patient, last visit (LPLV).|Day 1 to 90 Days after the last dose, up to May 2014|All participants in the study who received at least one dose of treatment with ipilimumab were summarized. Data up to May 2014 included.|||participants|||Number
2616348|NCT01990820|Primary|Quality of Life (QoL) Outcomes Between Adenoidectomy + Maxillary Sinus Irrigation With or Without the Use of Balloon Dilation or Maxillary Sinus Ostia.|"The care giver for each subject will be asked to complete SN-5 Pediatric sinonasal symptom survey (SN-5) at baseline (prior to surgery) and 6 and 12 months post surgery.~The SN-5 is a health-related qualify of life (QOL) questionnaire which consists of 5 questions about sinus problems (sinus infection, nasal obstruction, allergy symptoms, emotional distress, activity limitations) each of which is scored by the caregiver on a 7 point response scale. The 5 responses are then averaged into an SN-5 overall score (1-7). 1 is the minimum value for the overall SN-5 (best QoL) and 7 is the maximum value (worst QoL) The questionnaire also asks the caregiver to grade overall health related quality of life using a visual analog scale from 0 (worse possible quality of life) to 10 (best possible quality of life). The visual analog scale is scored separately from the SN-5 average score."|6 and 12 months postoperatively||||score on a scale||Standard Deviation|Mean
2616349|NCT01990794|Secondary|Changes in Neurological Function (Velocity)|Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90, and ~4-6 post-weeks).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||m/s||Standard Deviation|Mean
2616350|NCT01990794|Secondary|Changes in Neurological Function (Sural Sensory Amplitude)|Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90, and ~4-6 post-weeks).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||Sural Sensory Amplitude (µV)||Standard Deviation|Mean
2616351|NCT01990794|Secondary|Changes in Visual Function (Mean Deviation and PSD)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion||||dB||Standard Deviation|Mean
2616352|NCT01990794|Secondary|Changes in Visual Function (VFI)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion||||VFI (%)||Standard Deviation|Mean
2616353|NCT01990794|Secondary|Changes in Visual Function (Cup Volume)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion||||mm^3||Standard Deviation|Mean
2616354|NCT01990794|Secondary|Changes in Visual Function (Average C:D Ratio)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||ratio||Standard Deviation|Mean
2616355|NCT01990794|Secondary|Changes in Visual Function (Average RNFL Thickness)|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||Average RNFL thickness (µm)||Standard Deviation|Mean
2616356|NCT01990794|Secondary|Changes in Cardiac Function (LA Volume Index)|Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||LA volume index (mL/m^2)||Standard Deviation|Mean
2616357|NCT01990794|Secondary|Changes in Cardiac Function (LVEF)|Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||LVEF (2D est) (%)||Standard Deviation|Mean
2616425|NCT01990612|Secondary|Duration of Respiratory Support|including ventilator, CPAP, high-flow nasal cannula (HFNC)|delivery through hospital discharge|One neonate had cardiorespiratory resuscitation and 0 days on mechanical ventilation, continuous positive airway pressure or high flow nasal cannula.|||Participants|||Count of Participants
2616359|NCT01990794|Secondary|Cobalt Urine Concentrations After Cessation of Cobalt Supplementation|A 24 hr urine collection for cobalt analysis was performed on three volunteers (two females and one male) at one, two, six and ten weeks post-dosing. The one male volunteer provided three consecutive 24-hr urine samples at the one and two week post-dosing time points; data for individual urine collections were averaged together to give an average one and two week post-dosing data concentration.|After cobalt supplementation|"Participants that completed three months of cobalt supplementation and volunteered to do additional urine collections after stopping cobalt supplementation. n represents the number of urine samples analyzd at each time point."|||µg/L||Standard Deviation|Mean
2616360|NCT01990794|Secondary|Cobalt Urine Concentrations|A 24 hr urine collection for cobalt analysis was performed at Day 14/16, Day 43/44 and Day 88/90.|During cobalt supplementation|Participants that completed three months of cobalt supplementation|||µg/L||Standard Deviation|Mean
2616361|NCT01990794|Secondary|Glucose Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual male baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For females, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.|||mg/dL||Standard Deviation|Mean
2616362|NCT01990794|Secondary|Triglyceride Levels After 3 Months of Cobalt Supplementation|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Triglyceride levels were assessed before cobalt dietary supplementation and after three months of supplementation.|Study volunteers were assessed before and at the end of cobalt supplementation|Participants that completed three months of cobalt supplementation|||mg/dL||Standard Deviation|Mean
2616363|NCT01990794|Secondary|Total Cholesterol Levels After 3 Months of Cobalt Supplementation|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Total cholesterol levels were assessed before cobalt dietary supplementation and after three months of supplementation.|Study volunteers were assessed before and at the end of cobalt supplementation|Participants that completed three months of cobalt supplementation|||mg/dL||Standard Deviation|Mean
2616364|NCT01990794|Secondary|HDL Cholesterol Levels After 3 Months of Cobalt Supplementation|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. HDL cholesterol levels were assessed before cobalt dietary supplementation and after three months of supplementation.|Study volunteers were assessed before and at the end of cobalt supplementation|Participants that completed three months of cobalt supplementation|||mg/dL||Standard Deviation|Mean
2616365|NCT01990794|Secondary|Aspartate Aminotransferase (AST) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||U/L||Standard Deviation|Mean
2616366|NCT01990794|Secondary|Alanine Aminotransferase (ALT) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||U/L||Standard Deviation|Mean
2616367|NCT01990794|Secondary|Creatinine Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||mg/dL||Standard Deviation|Mean
2616368|NCT01990794|Secondary|Creatine Creatine Kinase-Myocardial Band (CK-MB) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual female baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For males, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.|||ng/mL||Standard Deviation|Mean
2616369|NCT01990794|Secondary|Ferritin Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual female baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For males, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.|||ng/mL||Standard Deviation|Mean
2616370|NCT01990794|Secondary|Total Iron Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||µg/dL||Standard Deviation|Mean
2616371|NCT01990794|Secondary|T4 Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation.Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||ng/dL||Standard Deviation|Mean
2616372|NCT01990794|Secondary|Thyroid-Stimulating Hormone (TSH) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||mIU/L||Standard Deviation|Mean
2616373|NCT01990794|Secondary|Albumin Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||g/dL||Standard Deviation|Mean
2616374|NCT01990794|Secondary|Protein Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||g/dL||Standard Deviation|Mean
2616375|NCT01990794|Secondary|Hematocrit Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||Percentage||Standard Deviation|Mean
2616376|NCT01990794|Secondary|Red Blood Cell (RBC) Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual male baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together. For females, the average baseline is the 1-wk predose data only because there was a significant difference between the 1-wk predose draw and the day 1 (predose) draw.|||million cells/µL||Standard Deviation|Mean
2616387|NCT01990768|Secondary|Number of Participants With Any Thromboembolic Event|Diagnosis of one or more of the following: cerebral ischemic event, myocardial infarction (MI), deep vein thrombosis (DVT), pulmonary embolism (PE), or any other thromboembolic event|From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)|Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.|||Participants|||Count of Participants
2617050|NCT01984424|Secondary|Percentage of Participants Who Achieved LDL-C at Week 24 of Less Than 70 mg/dL||Week 24|Participants randomized and dosed in Part B of the study|||percentage of participants||95% Confidence Interval|Number
2616377|NCT01990794|Secondary|White Blood Cell (WBC) Levels After 1, 2 and 3 Months of Cobalt Dietary Supplementation|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||thousand cells/µL||Standard Deviation|Mean
2616378|NCT01990794|Primary|Cobalt Whole Blood Concentrations|The cobalt concentration in whole blood and serum was determined one to two weeks pre-dosing and on the day of the first day of dosing before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, and Day 88/90. Cobalt concentration in whole blood and serum was also determined at one, two, six, ten and 16 weeks post-dosing.|Before, during and after cobalt supplementation|Participants that completed three months of cobalt supplementation|||µg Co/L||Standard Deviation|Mean
2616379|NCT01990794|Secondary|Changes in Neurological Function (Peroneal Motor Amplitude)|Values of the sural sensory and peroneal motor variables. Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90, and ~4-6 post-weeks).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||Peroneal Motor Amplitude (mV)||Standard Deviation|Mean
2616380|NCT01990794|Secondary|Changes in Visual Function|Ophthalmology studies included an assessment of visual acuity, slit lamp evaluations, and visual field testing. Retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) were assessed using optical coherence tomography (OCT). Volunteers served as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||mm^2||Standard Deviation|Mean
2616381|NCT01990794|Secondary|Changes in Cardiac Function|Two-dimensional and Doppler echocardiographic examinations were used to assess cardiac anatomy, structure, and function during the study with volunteers serving as their own baseline controls for changes during the study (i.e., week 0, ~day 45, ~day 90).|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||cm||Standard Deviation|Mean
2616382|NCT01990794|Secondary|Changes in Audiological Function|Audiologic assessments including pure tone threshold determination at frequencies ranging from 250 to 16000 Hz were performed with volunteers serving as their own baseline controls for receptive changes during the study (i.e., week 0, ~day 45, ~day 90). Audiologic assessments including a pure-tone threshold determination at frequencies that ranged from 250 to 16000 Hz were performed with volunteers serving as their own baseline controls for receptive changes during the study. Decreases in hearing were considered clinically significant when one of the following 3 American Speech-Language-Hearing Association criteria were met: 1) a ≥20-dB decrease in the pure-tone threshold at one test frequency, 2) a ≥10-dB decrease at 2 adjacent test frequencies, or 3) the loss of 3 consecutive test frequencies where responses were previously obtained.|Baseline, at the study midpoint, and at the study completion|Participants that completed three months of cobalt supplementation|||dB||Standard Deviation|Mean
2616383|NCT01990794|Secondary|Hemoglobin Levels After 1, 2 and 3 Months of Dosing|Blood chemistries assessed during the study included a lipid panel, comprehensive metabolic panel, creatine kinase-myocardial band, thyroid stimulating hormone, free thyroxine, and complete blood count with differential, total iron, and ferritin. Blood chemistries were assessed at one or two week pre-dose, pre-dose/ Day 1 before taking the supplement, Day 29/30, Day 57/58, Day 88/90 and one and two weeks post-dose.|Study volunteers were assessed before, during and after cobalt supplementation (2 wk post)|Participants that completed three months of cobalt supplementation. Individual baseline values for the 1-wk predose draw and the day 1 (predose) draw were averaged together to give one baseline value.|||g/dL||Standard Deviation|Mean
2616384|NCT01990794|Secondary|Effects on the Immune System|Sensitivity to metals before and after cobalt supplementation was assessed by an in vitro lymphocyte transformation test (LTT) performed at week 0 and after three months of cobalt supplementation. The average proliferation rate for each metal treatment was normalized to individual proliferation rates of untreated control cells which generated a stimulation index (SI). According to the manufacture, the SI ranges from 0-15, with an SI from 2 to 4 indicated mild reactivity, from 5 to 8 indicated moderate reactivity, and >8 indicated high reactivity to the metal. The data is presented as the averaged normalized lymphocyte transformation response to each metal in men and women combined (n = 10).|0 weeks and three months|Participants that completed three months of cobalt supplementation|||units on a scale: stimulation index (SI)||Standard Deviation|Mean
2616385|NCT01990794|Secondary|Albumin Bound Cobalt Fraction in Serum|The fraction of albumin bound cobalt in serum was determined one to two weeks pre-dosing and on the day of the first dose before taking the supplement. Samples were also analyzed during the dosing period as follows: Day 4/5, Day 8/9, Day 14/16, Day 22/23, Day 29/30, Day 43/44, Day 57/58, Day 71/72, Day 88/90 and the fraction of albumin bound cobalt in serum was also determined at one and two weeks post-dosing.|Study volunteers will be followed for the duration of the study, an average of about 8 months for most volunteers|Analysis was carried out on the first 12 participants of the study|||percentage of total blood cobalt||Standard Deviation|Mean
2616386|NCT01990768|Other Pre-specified|Fibrinolysis at Hospital Admission|Alterations in fibrinolysis based on fibrinolytic pathway mediators and degree of clot lysis based on kaolin-activated thromboelastography (TEG) and defined as LY30 or the per cent lysis that occurs 30 minutes after maximum amplitude (MA) is achieved. LY30 is categorized as <0.8% (fibrinolysis shutdown), 0.8-3% (normal), and >3% (hyperfibrinolysis).|First blood draw (average of 1.6 hours post-injury)|Subjects with an LY30 measurement at hospital admission are included. Subjects who were transported to trauma centers without a TEG machine, who died prior to the initial blood draw, or who withdrew or refused a blood draw were excluded. Additional exclusions included blood draw missed by study staff and technical difficulties with processing.|||Participants|||Count of Participants
2616426|NCT01990612|Secondary|Number of Participants With Indications for Cesarean Delivery|Number of participants with indications for cesarean delivery including dystocia, non-reassuring fetal status or other indication|Labor and delivery||||Participants|||Count of Participants
2616392|NCT01990768|Secondary|Number of Participants With Seizure|Seizures may cause involuntary changes in body movement or function, sensation, awareness, or behavior. Seizures are often associated with a sudden and involuntary contraction of a group of muscles and loss of consciousness. Seizures or episodes of seizure-like activity were reported by medics in the field following the start of study drug infusion through hand-off to the trauma center and by trauma center staff through discharge. Reported events were included if providers gave anti-seizure medication and/or the event was confirmed by EEG.|From start of study drug infusion through 28 days or the end of the hospital stay if sooner (average of 9 days)|Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.|||Participants|||Count of Participants
2616393|NCT01990768|Secondary|Ventilator-free Days|Ventilator-free days count any day from hospital admission through day 28 that the patient is alive and does not require mechanical ventilatory support. Subjects who die prior to discharge (even if after 28 days) are assigned a value of 0.|From hospital admission through day 28|Subjects for whom study drug administration was started and for whom number of ventilator days through 28 days was known. Subjects who withdrew prior to discharge make up most of the subjects who were excluded from this analysis.|||days||Standard Deviation|Mean
2616394|NCT01990768|Secondary|Intensive Care Unit (ICU)-Free Days|ICU-free days count any day from hospital admission through day 28 that the patient is alive and not in the ICU. Subjects who die prior to discharge (even if after 28 days) are assigned a value of 0.|From hospital admission through day 28|Subjects for whom study drug administration was started and for whom number of ICU days through 28 days was known. Subjects who withdrew prior to discharge make up most of the subjects who were excluded from this analysis.|||days||Standard Deviation|Mean
2616395|NCT01990768|Secondary|Hospital-free Days|Hospital-free days count any day from hospital admission through day 28 that the patient is alive and out of the hospital.|From hospital admission through day 28|Subjects for whom study drug administration was started and for whom discharge status was known. Subjects who withdrew prior to discharge make up most of the subjects who were excluded from this analysis.|||days||Standard Deviation|Mean
2616396|NCT01990768|Secondary|Number of Participants With One or More Neurosurgical Interventions|Neurosurgical interventions include craniotomy, craniectomy, and placement of a neuromonitoring or drainage device. Counts are of subjects with one or more neurosurgical interventions.|From hospital admission through 28 days or the end of the hospital stay if sooner (average of 9 days)|Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.|||Participants|||Count of Participants
2616397|NCT01990768|Secondary|Rotterdam Computed Tomography (CT) Score Among Subjects With Intracranial Hemorrhage (ICH) on Initial Head CT|The Rotterdam classification includes four independently scored elements: degree of basal cistern compression, degree of midline shift, presence of epidural hematomas, and presence of intraventricular or subarachnoid blood. The elements are combined to form an overall score from 1 to 6 with higher scores having worse prognosis and survival.|Initial head CT (average of 1.9 hours post-injury)|Subjects determined by the central image reviewer to have an intracranial hemorrhage (ICH) on the initial head computed tomography (CT) scan and sufficient information to assign the Rotterdam score.|||Participants|||Count of Participants
2616398|NCT01990768|Secondary|Marshall Computed Tomography (CT) Score on Initial Head CT|The Marshall classification categorizes patients into one of six categories (I to VI) of increasing severity on the basis of findings on non-contrast CT scan of the brain. Higher categories have worse prognosis and survival.|Initial head CT (average of 1.9 hours post-injury)|Subjects who received an initial head computed tomography scan with sufficient information to be scored.|||Participants|||Count of Participants
2616399|NCT01990768|Secondary|Number of Participants With Intracranial Hemorrhage (ICH) Progression|All clinically indicated head computed tomography (CT) scans obtained during the initial hospitalization or within the first 28 days were assessed for ICH. Parenchymal (IPH), subdural (SDH) and epidural (EDH) hemorrhage volumes were measured and quantified using volumetric software and verified by manual calculations based on the previously validated ABC/2 technique. The sum of the IPH, SDH, and EDH volumes were compared across scans. A relative increase of 33% (and at least a 1 ml increase) on any subsequent scan compared to the initial scan was defined as a progression.|From hospital admission through 28 days or the end of the hospital stay if sooner (average of 13 days among patients with multiple scans)|Subjects for whom study drug administration was started and for whom two or more analyzable head CT scans were obtained prior to a hematoma evacuation. Excluded subjects primarily include those who died or withdrew before an initial or second CT scan was taken, who had a hematoma evacuation prior to a second scan, or who had only one negative CT.|||Participants|||Count of Participants
2616400|NCT01990768|Secondary|Disability Rating Scale (DRS) at Discharge|The DRS is designed to classify patients based on their degree of function after brain injury. The DRS consists of 8 items that fall into 4 categories: (a) arousability, awareness and responsivity, (b) cognitive ability for self-care activities, (c) dependence on others, and (d) psychosocial adaptability. The score ranges from 0 (no disability) to 30 (death).|At the end of the hospital stay (average of 9 days post injury)|Subjects for whom study drug administration was started and for whom discharge Disability Rating Scale was obtained. Subjects who withdrew prior to discharge make up most of the subjects who were excluded from this analysis.|||score on a scale||Standard Deviation|Mean
2616401|NCT01990768|Secondary|Number of Participants With Unfavorable Outcome on Dichotomized Glasgow Outcome Scale Extended (GOS-E) at Discharge|GOS-E subdivides the categories of severe and moderate disability and good recovery using a scale of 1 to 8 where 1 = death, 2 = vegetative state, 3 = lower severe disability, 4 = upper severe disability, 5 = lower moderate disability, 6 = upper moderate disability, 7 = lower good recovery, and 8 = upper good recovery. Structured telephone interviews have been developed and validated for the GOS-E and these questions were incorporated into the follow-up survey. GOS-E was dichotomized into unfavorable (1 to 4) and favorable (5 to 8) outcomes. The number of subjects with unfavorable outcome is reported.|At the end of the hospital stay (average of 9 days post injury)|Subjects for whom study drug administration was started and for whom Glasgow Outcome Score Extended was obtained at discharge. Subjects who withdrew prior to discharge make up most of the subjects who were excluded from this analysis.|||Participants|||Count of Participants
2616427|NCT01990612|Secondary|Number of Participants With Venous Thromboembolism|Maternal deep venous thrombosis or pulmonary embolism|delivery through discharge||||Participants|||Count of Participants
2616402|NCT01990768|Secondary|Disability Rating Scale (DRS) at 6 Months|The DRS is designed to classify patients based on their degree of function after brain injury. The DRS consists of 8 items that fall into 4 categories: (a) arousability, awareness and responsivity, (b) cognitive ability for self-care activities, (c) dependence on others, and (d) psychosocial adaptability. The score ranges from 0 (no disability) to 30 (death).|6 months post-injury|Subjects for whom study drug administration was started and DRS questions were obtained at 6 months. Excluded subjects include those who withdrew prior to 6 months after injury and those lost to follow-up.|||score on a scale||Standard Deviation|Mean
2616403|NCT01990768|Secondary|Number of Participants Who Died Within 28 Days|The counts of patients who died on or before day 28 are reported.|28 days after hospital arrival|Subjects for whom study drug administration was started and 28-day vital status was definitively obtained. Patients excluded from the counts include subjects who withdrew from the study prior to day 28 and subjects who were lost to follow-up.|||Participants|||Count of Participants
2616404|NCT01990768|Primary|Dichotomized Glasgow Outcome Scale Extended (GOS-E) at 6 Months|GOS-E subdivides the categories of severe and moderate disability and good recovery using a scale of 1 to 8 where 1 = death, 2 = vegetative state, 3 = lower severe disability, 4 = upper severe disability, 5 = lower moderate disability, 6 = upper moderate disability, 7 = lower good recovery, and 8 = upper good recovery. Structured telephone interviews have been developed and validated for the GOS-E and these questions were incorporated into the follow-up survey. GOS-E was dichotomized into unfavorable (1 to 4) and favorable (5 to 8) outcomes.|6 months post-injury|Subjects for whom study drug administration was started minus one Bolus Only arm subject who was mistakenly enrolled while in police custody.|||Participants|||Count of Participants
2616405|NCT01990742|Other Pre-specified|Number of Nursing Home Residents in Moderate-to-severe Pain|Presence of moderate-to-severe pain within 6 months of the date of death, among decedents cared for in the enrolled nursing homes. The verbal descriptor pain scale, where the resident is asked to rate the intensity of their worst pain in the last five day was most often used, where 0 = no pain, 1 = mild pain , 2 = moderate pain, 3 = severe pain, 4 = very severe pain, and 9 = unable to answer. Lower numbers (0 or 1 ) on the scale are preferred, and a lower percentage of residents reporting pain intensity in the moderate or higher ranges is a better outcome. The verbal descriptor scale can be shared with elders verbally, as the name implies, or by asking the resident to point to a setting on a visual thermometer with these word choices.|up to 6 months prior to death|Decedents cared for in assigned nursing home facilities for whom data on pain was available|||Participants|||Count of Participants
2616406|NCT01990742|Secondary|Hospitalizations|Number of hospitalizations in the last 90 days of life among decedents being cared for in the enrolled nursing homes|The last 90 days of life|Decedents with data on hospitalizations in the last 90 days of life|||Mean number of hospitalizations||Standard Deviation|Mean
2616407|NCT01990742|Primary|Hospital Site of Death: Number of Decedents Cared for in an Enrolled and Assigned NH Facility, Who Were Transferred to a Hospital and Died in the Hospital During the Study Period|This outcome measure, Hospital Site of Death, assesses whether death occured in a nursing home or in a hospital following transfer from the nursing home, among nursing home residents who were cared for in an enrolled facility.|1 year|Nursing home residents cared for in an assigned facility, who died during the study timeframe|||Participants|||Count of Participants
2616408|NCT01990703|Secondary|Time to Lactogenesis Stage 2|To evaluate potential delay in lactogenesis caused by immediate postpartum insertion of the LNG IUD.|First 5 days after birth||||Hours||Standard Deviation|Mean
2616409|NCT01990703|Primary|Breastfeeding Continuation Rates at 8 Weeks Postpartum|To determine breastfeeding continuation rates at 8 weeks in women randomized to immediate post-placental vs. delayed (4-8 weeks) postpartum levonorgestrel IUD insertion.|8 weeks postpartum|147 Early IUD Insertion participants at baseline drops to 112 at 8 weeks due to exclusions for medical complications (n=15), inability to provide immediate IUD (n=7) and loss to follow up (n=13). In the Standard Insertion group 138 at baseline drops to 102 at 8 weeks with medical comps (n=11), failure to receive IUD (n=24), and 1 loss to follow up.|||Participants|||Count of Participants
2616410|NCT01990677|Other Pre-specified|Proportion of Eyes Demonstrating a Reduction in Subretinal Fluid on OCT|Proportion of eyes having a decrease in subretinal fluid on spectral domain OCT from baseline to month 2 in chronic CSCR patients receiving placebo versus eplerenone.|Baseline and Month 2|Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.|||Eyes|Eyes||Count of Units
2616411|NCT01990677|Secondary|Mean Change in Subfoveal Fluid Height Based on OCT Measurement|Mean change in subfoveal fluid height based on spectral domain OCT measurement from baseline to month 2 in chronic CSCR patients receiving placebo versus eplerenone.|Baseline and Month 2|Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.|||microns|Eyes|Standard Deviation|Mean
2616412|NCT01990677|Primary|Mean Change in Maximal Subretinal Fluid Height Based on Spectral Domain Optical Coherence Tomography (OCT) Measurement.|Mean change in maximal subretinal fluid height based on spectral domain OCT from baseline to month 2 in chronic central serous chorioretinopathy (CSCR) patients receiving placebo versus eplerenone.|Baseline and 2 months|Significant acute data collection missing therefore only chronic arm data analysis was reviewed and entered into results data.|||microns|Eyes|Standard Deviation|Mean
2616413|NCT01990664|Primary|Proportion of Successfully Re-fitted Subjects|Percentage of lapsed contact wearers who were successfully refitted among subjects who have lapsed from contact lens use more than 6 months prior to the date of enrollment in the study. Successful fit was assessed by on eye care practitioner (ECP) judgment of acceptable physiology.|4 weeks|The analysis population includes all subjects who have completed all study visits without a major protocol deviation.|||percentage of Subjects|||Number
2616414|NCT01990612|Secondary|Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery|Breastfeeding status includes breastfeeding, breastfeeding and formula feeding, or formula feeding|4-8 weeks after delivery|breastfeeding status at 4-8 wk after delivery missing in 642 (299 IOL; 343 EM)|||Participants|||Count of Participants
2616415|NCT01990612|Secondary|Number of Participants With Indications for Operative Vaginal Delivery|Number of participants with indications for operative vaginal delivery including dystocia, non-reassuring fetal status and other indications|Labor and delivery||||Participants|||Count of Participants
2616416|NCT01990612|Secondary|Neonatal Length of Hospital Stay||delivery through hospital discharge|Data is missing for 5 participants|||Participants|||Count of Participants
2616428|NCT01990612|Secondary|Number of Participants With Maternal Postpartum Infection|"Defined as any of the following:~Clinical diagnosis of endometritis~Wound reopened for hematoma, seroma, infection or other reasons~Cellulitis requiring antibiotics~Pneumonia~Pyelonephritis~Bacteremia - unknown source~Septic pelvic thrombosis"|delivery through discharge||||Participants|||Count of Participants
2616429|NCT01990612|Secondary|Labor Pain Scores|Labor pain was scored according to a 10-point Likert scale, with higher scores indicating greater pain; included are women who had spontaneous labor, labor that started spontaneously but then was augmented, or induced labor.|During labor and delivery|Data on worst score are missing for 274 women (110 in the induction group and 164 in the expectant-management group); data on overall score are missing for 275 women (110 in the induction group and 165 in the expectant-management group).|||score on a scale||Inter-Quartile Range|Median
2616430|NCT01990612|Secondary|Labor Agentry Scale Scores|Scores on the Labor Agentry Scale range from 29 to 203, with higher scores indicating greater perceived control during childbirth; included are women who had spontaneous labor, labor that started spontaneously but then was augmented, or induced labor.|Between 6 hours after delivery and 8 weeks after delivery|Data for 6 to 96 hours after delivery are missing for 288 women (127 in the induction group and 161 in the expectant-management group); data for 4 to 8 weeks after delivery are missing for 736 women (349 in the induction group and 387 in the expectant-management group).|||score on a scale||Inter-Quartile Range|Median
2616431|NCT01990612|Secondary|Number of Participants With Postpartum Hemorrhage|"defined as any of the following:~Transfusion~Non-elective hysterectomy~Use of two or more uterotonics other than oxytocin~Other surgical interventions such as uterine compression sutures, uterine artery ligation, embolization, hypogastric ligation, or balloon tamponade~Curettage"|delivery through hospital discharge||||Participants|||Count of Participants
2616432|NCT01990612|Secondary|Number of Participants Experiencing Hypertensive Disorder of Pregnancy||Randomization to hospital discharge||||Participants|||Count of Participants
2616433|NCT01990612|Secondary|Number of Participants Admitted to Intensive Care Unit (ICU)|Admission of the participant to the intensive care unit (ICU)|delivery through hospital discharge||||Participants|||Count of Participants
2616434|NCT01990612|Secondary|Number of Maternal Deaths|Maternal death at anytime between randomization and hospital discharge.|from randomization to hospital discharge||||Participants|||Count of Participants
2616435|NCT01990612|Secondary|Number of Participants With Third or Fourth Degree Perineal Laceration||delivery||||Participants|||Count of Participants
2616436|NCT01990612|Secondary|Number of Participants Who Had Chorioamnionitis|Chorioamnionitis, defined as a clinical diagnosis before delivery|at any time from randomization through delivery||||Participants|||Count of Participants
2616437|NCT01990612|Secondary|Participants Who Had Operative Vaginal Delivery||delivery||||Participants|||Count of Participants
2616438|NCT01990612|Secondary|Number of Participants Who Had Uterine Incisional Extension at Cesarean Delivery|Incisional extensions at cesarean section, including J shape or T shape; or cervical traumas|delivery|Neonatal length of hospital stay missing in 5 (2 induction group (IOL); 3 expectant-management group (EM)); incisional extensions at cesarean section missing in 9 (5 IOL; 4 EM); breastfeeding status at 4-8 wk after delivery missing in 642 (299 IOL; 343 EM).|||Participants|||Count of Participants
2616439|NCT01990612|Secondary|Number of Participants With Cesarean Delivery||delivery||||Participants|||Count of Participants
2616440|NCT01990612|Primary|Hypotension Requiring Vasopressor Support (Component of Primary Outcome)||delivery through discharge||||Participants|||Count of Participants
2616441|NCT01990612|Primary|Number of Infants With Intracranial or Subgaleal Hemorrhage (Component of Primary Outcome)|Intracranial or subgaleal hemorrhage includes Intraventricular hemorrhage grades III or IV, subdural hematoma, subarachnoid hematoma, and subgaleal hematoma|delivery through disharge||||Participants|||Count of Participants
2616442|NCT01990612|Primary|Number of Infants With Birth Trauma (Component of Primary Outcome)|Birth trauma includes clavicular, skull or other fracture; brachial plexus palsy, facial nerve palsy, retinal hemorrhage or vocal cord paralysis|During the Delivery process||||Participants|||Count of Participants
2616443|NCT01990612|Primary|Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome)||Delivery through discharge||||Participants|||Count of Participants
2616444|NCT01990612|Primary|Number of Infants With Neonatal Infection (Component of Primary Outcome)|Neonatal infection includes confirmed sepsis and/or confirmed pneumonia|delivery through discharge||||Participants|||Count of Participants
2616445|NCT01990612|Primary|Number of Infants With Neonatal Seizure (Component of Primary Outcome)||Delivery through discharge||||Participants|||Count of Participants
2616446|NCT01990612|Primary|Number of Infants With Neonatal Hypoxic-ischemic Encelphalopathy (Component of Primary Outcome)||delivery through discharge||||Participants|||Count of Participants
2616447|NCT01990612|Primary|Number of Infants With Apgar Score ≤3 at 5 Minutes (Component of Primary Outcome)|The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.|Delivery through 5 minutes after birth||||Participants|||Count of Participants
2616448|NCT01990612|Primary|Number of Participant Infants Requiring Respiratory Support (Component of Primary Outcome)|Respiratory support includes mechanical ventilation, continuous positive airway pressure or high flow nasal cannula and cardiorespiratory resuscitation|Delivery through discharge||||Participants|||Count of Participants
2616449|NCT01990612|Primary|Perinatal Death (Component of Primary Outcome)|Perinatal death includes antepartum stillbirth, intrapartum stillbirth and neonatal death|antepartum pregnancy period through hospital discharge||||Participants|||Count of Participants
2616450|NCT01990612|Primary|Composite of Severe Neonatal Morbidity and Perinatal Mortality|"Includes any one of:~Perinatal death~Need for respiratory support within 72 hours after birth~Apgar score of 3 or less at 5 minutes~Hypoxic-ischemic encephalopathy~Seizure~Infection (confirmed sepsis or pneumonia)~Meconium aspiration system~Birth trauma (bone fracture, neurologic injury or retinal hemorrhage)~Intracranial or subaleal hemorrhage~Hypotension requiring vasopressor support"|delivery through 72 hours after birth|The analysis was intent to treat.|||Participants|||Count of Participants
2616451|NCT01990573|Secondary|Cmax of R and S Methadone|Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose.|96 hours|Methadone clearance was only measured in the two groups that received methadone|||ng/ml||Standard Deviation|Mean
2616452|NCT01990573|Primary|Pain Scores|Assessments are made in the postoperative period by a trained member of the research team blinded to intraoperative use of methadone. These will be conducted on each post-operative day until discharge or post op day 6, whichever comes first. Pain intensity is assessed using the numeric pain score (0-10) scale employed by the inpatient nursing staff and previously validated .|6 days||||score on a scale||Standard Deviation|Mean
2616453|NCT01990573|Primary|Total Opioid Consumption (Morphine Equivalent)|Measure of overall morphine consumption|6 days||||mg/kg||Standard Deviation|Mean
2616454|NCT01990560|Secondary|State Trait Anxiety Inventory (STAI)|Change in Quality of Life - as assessed by the State Trait Anxiety Inventory (STAI). The State-Trait Anxiety Inventory both state and trait anxiety separately. Each type of anxiety has its own scale of 20 different questions that are scored and averaged. Total scores range from 20 to 80, with higher scores correlating with greater anxiety.|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
2616455|NCT01990560|Secondary|Quality of Life|Change in Quality of Life as assessed by the Beck Depression Inventory. a 21-question multiple choice, self-report inventory that is used for measuring the severity of anxiety. Scoring is from a 0 (not at all) to 3 (severe) with a total score range of 0-63. Higher total scores indicate more severe anxiety symptoms.|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
2616456|NCT01990560|Secondary|Hospital Anxiety and Depression Scale (HADS)|Change in Quality of Life as assessed by the Hospital Anxiety and Depression Scale (HADS). Questionnaire with 7 items for anxiety and 7 items for depression, each item is scored on a 4 point response 0 - 3, with full range from 0 to 42, with higher score indicating more severe anxiety or depression|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
2616457|NCT01990560|Secondary|Nottingham Health Profile (NHP)|Change in Quality of Life as assessed by the Nottingham Health Profile (NHP) which is a patient reported questionnaire to measure a patient's view of their own health status. There are 6 sections (Energy level, Pain, Emotional Reaction, Sleep, Social Isolation, and Physical Abilities. All questions have only yes/no answer options and each section score is weighted so that the possible score range for any section is 0-100. The higher the score, the greater the number and severity of problems.|Baseline and 6 months||||units on a scale||Inter-Quartile Range|Mean
2616458|NCT01990560|Secondary|CushingQoL|Change in Quality of Life - as assessed by the Cushing's Quality of Life questionnaire (CushingQoL). Patient completed questionnaire, 12 items, each scored on a 5 point score, resulting in a score of 12 (worst) to 60 (best) where higher scores indicate more favorable QOL.|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
2616459|NCT01990560|Secondary|Weight|Change in metabolic syndrome as assessed by weight|Baseline and 6 months|one participant had data missing at 6 months|||kg||Standard Deviation|Mean
2616460|NCT01990560|Secondary|Fasting Lipid Profile|Change in metabolic syndrome as assessed by fasting lipid profile which includes Low-density lipoproteins ( LDL), High-density lipoproteins (HDL), and Triglycerides (Trigs) levels, and total cholesterol which is the sum of HDL plus LDL and 20% of trigs.|Baseline and 6 months|one participant data missing at 6 month|||mg/dL||Standard Deviation|Mean
2616461|NCT01990560|Secondary|Body Mass Index (BMI)|Change in metabolic syndrome as assessed by BMI|Baseline and 6 months||||kg/m2||Standard Deviation|Mean
2616462|NCT01990560|Secondary|Waist Circumference|Change in metabolic syndrome as assessed by waist circumference|Baseline and 6 months||||cm||Standard Deviation|Mean
2616463|NCT01990560|Primary|HOMA-IR|Change in hyperglycemia assessed by Homeostatic Model Assessment of Insulin Resistance, HOMA-IR (a validated assessment of insulin resistance). HOMA-IR = fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.|Baseline and 6 months|one participant on insulin. another participant had data missing at 6 months.|||HOMA-IR score||Standard Deviation|Mean
2616464|NCT01990560|Primary|A1C Level|Change in hyperglycemia assessed by HbA1c, also known as glycated hemoglobin|Baseline, 3 months, and 6 months||||percentage of red blood cells||Standard Deviation|Mean
2616465|NCT01990534|Secondary|Number of Participants With Antitherapeutic Antibodies (ATA)|Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA development) using a laboratory test. Confirmed ATA-positive response was categorized as transient (defined as 1 or 2 post-Baseline confirmed ATA-positive responses) and persistent (defined as more than 2 post-Baseline confirmed ATA positive responses) and neutralizing ATA (nATA) status. The confirmed ATA-positive samples were assessed for ATA titer and delineated into having high or low titers.|Day 1 of every 3-week cycle up to 16 cycles and EOT (Up to 12.2 months)|Participants from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis.|||participants|||Number
2616466|NCT01990534|Secondary|Monomethyl Auristatin E (MMAE) Serum Concentrations|Blood samples were collected and tested for MMAE serum concentrations.|Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 12.2 months)|"PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. n in the categories is the number of participants with data available at the given time-point."|||pg/mL||Standard Deviation|Mean
2616467|NCT01990534|Secondary|Serum Concentration of Total Antibodies (Conjugated and Unconjugated)|Blood samples were collected and tested for conjugated and unconjugated antibodies.|Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 12.2 months)|"PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. n in the categories is the number of participants with data available at the given time-point."|||ng/mL||Standard Deviation|Mean
2616493|NCT01989975|Secondary|Number of Participants With Serious Adverse Events|Descriptive summary of number and type of serious adverse events (SAE)|Outcome measured after 15 days of use of the CareLink Connect Device||||Participants|||Count of Participants
2616468|NCT01990534|Secondary|Antibody-drug Conjugate (ADC) Serum Concentrations|Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.|Cycle 1 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 2 pre-dose and 10 minutes post-dose; Cycle 3 pre-dose and 10 minutes, 24 hours and 336 hours post-dose; Cycle 4 to 16 pre-dose and 10 minutes post-dose; EOT (Up to 12.2 months)|"Pharmacokinetic (PK) evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. n in the categories is the number of participants with data available at the given time-point."|||ng/mL||Standard Deviation|Mean
2616469|NCT01990534|Secondary|Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs|Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.|From the first dose through 30 days after the last dose of study medication (Up to 12.2 months)|Safety population was defined as all enrolled participants who received at least one dose of brentuximab vedotin.|||participants|||Number
2616470|NCT01990534|Secondary|Number of Participants With Adverse Events (AEs), Drug-Related AEs, Grade 3 or Higher AEs, Serious Adverse Events (SAEs), Drug-Related SAEs and Grade 3 or Higher SAEs|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. AEs Grade 3 and higher are severe.|From first dose through 30 days after the last dose of study medication [Up to 12.2 months, except for peripheral neuropathy (PN), all PN events will be followed for all changes in severity until resolution to baseline or study closure (Up to 24 months)]|Safety population was defined as all enrolled participants who received at least one dose of brentuximab vedotin.|||participants|||Number
2616471|NCT01990534|Secondary|Percentage of Participants Who Received Stem Cell Transplantation (SCT)||Baseline up to EOS (Up to 24 months)|ITT population included all participants who were enrolled in the study.|||percentage of participants|||Number
2616472|NCT01990534|Secondary|Overall Survival (OS)|OS is the time in months from start of study treatment to date of death due to any cause.|Every 3 months for 18 months after EOT, thereafter, every 6 months until the sooner of death, study closure, or 5 years after enrollment of the last participant up to data cut-off: 24 March 2016 (approximate median follow-up 16.6 months)|ITT population included all participants who were enrolled in the study. In the absence of confirmation of death, survival time is censored at the last date the participant is known to be alive, including study closure.|||months||95% Confidence Interval|Median
2616473|NCT01990534|Secondary|Duration of Complete Remission (CR)|Duration of CR is defined as the time from the date of first documentation of a CR or to the date of first documentation of tumor progression or progressive disease (PD) per IRF assessment according to IWG criteria. CR is defined as the disappearance of all evidence of disease and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.|From first documented response until disease progression (Up to 24 months)|ITT population included all participants who were enrolled in the study. In the absence of confirmation of death, survival time is censored at the last date the patient is known to be alive, including study closure.|||months||95% Confidence Interval|Median
2616474|NCT01990534|Secondary|Complete Remission Rate|Complete remission rate is defined as percentage of participants with CR per IRF response assessment based on IWG criteria are reported. CR is defined as the disappearance of all evidence of disease.|Baseline until disease progression, death or EOS (Up to 24 months)|ITT population included all participants who were enrolled in the study. In the absence of confirmation of death, survival time is censored at the last date the participant is known to be alive, including study closure.|||percentage of participants||95% Confidence Interval|Number
2616475|NCT01990534|Secondary|Progression Free Survival (PFS)|PFS is defined as time in months from start of study treatment to first documentation of objective tumor progression per IRF assessment or up to death due to any cause, whichever occurs first.|Baseline until disease progression, death or end of treatment (EOT), and then every 3 months up to data cut-off: 24 March 2016 (approximate median follow-up 6.9 months)|ITT population included all participants who were enrolled in the study. For a participant that has not progressed and has not died, PFS is censored at the last response assessment that is SD or better.|||months||95% Confidence Interval|Median
2616476|NCT01990534|Secondary|Duration of Response (DOR)|DOR is defined as the time in months from the date of first documentation of a CR response to the date of first documentation of tumor progression or progressive disease (PD) per IRF assessment according to IWG criteria. CR is defined as the disappearance of all evidence of disease and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.|From first documented response until disease progression (Up to 24 months)|ITT population included all participants who were enrolled in the study. All responders were evaluated in this outcome measure. For a participant that has not progressed, DOR is censored at the last response assessment that is SD or better.|||months||95% Confidence Interval|Median
2616477|NCT01990534|Primary|Objective Response Rate (ORR)|Objective response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.|Baseline until disease progression, death or end of study (EOS) (Up to 24 months)|Intent-to-Treat (ITT) population included all participants who were enrolled in the study.|||percentage of participants||95% Confidence Interval|Number
2616729|NCT01987609|Secondary|Change in Toll-like Receptor 9 (TLR-9) Expression|RT-PCR techniques will be used to determine expression levels of the TLR-9 in all skin biopsies. The expression levels of this receptor in skin biopsies at week 4 will be compared to the expression levels at baseline.|4 weeks|Data not collected.||||||
2616478|NCT01990339|Secondary|Frequency of Adverse Events (Adverse Drug Reactions)|Adverse events observed during the observation period were collected by symptom. For adverse drug reactions, frequencies were tabulated by type and seriousness. Adverse events were defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of lansoprazole whether or not it was considered related to treatment. Among these, events that were considered as having a causal relationship with lansoprazole were defined as adverse drug reactions. The rate of participants with adverse events (adverse drug reactions) was reported.|4 Weeks|Safety analysis set included all enrolled participants with data available (8 patients were excluded for Investigator's medical reasons; 41 were excluded for other reasons), 1402 patients who did not visit the study site after initial prescription were also excluded.|||percentage of participants|||Number
2616479|NCT01990339|Primary|Subjective Symptom Improvement Rate|"Subjective symptoms were evaluated as Disappeared, Improved, No change, Worsened, or Unclear. These categories were based on investigator's definitions. At Week 4, the rate of improvement (i.e. the frequency of an evaluation of Disappeared + Improved) was calculated for each symptom. The percentage of participants with Improvement by symptom was reported."|Start of treatment and Week 4|Efficacy set included all enrolled participants with data available (8 patients were excluded for Investigator's medical reasons; 41 were excluded for other reasons), 1402 patients who did not visit the study site after initial prescription and 861 patients whose questionnaires were not reviewed at either Week 2 or Week 4 were also excluded.|||percentage of participants|||Number
2616480|NCT01990313|Primary|Sample Beta Entropy|Sample entropy is a measure of estimated conditional predictability, calculated within a frequency range of a patient's local field potential. Freezers are subjects who have clinical history of freezing of gait symptoms and/or if the subject displayed freezing behavior pre-operatively or during the in-study gait tasks relative to non-freezers, those who have never experienced freezing of gait. We measured sample beta (13-30 Hz) entropy in subjects' local field potential. Higher values of sample entropy indicate lower estimated conditional predictability. Testing occurred over one day, at a range of approximately 1 month to 7 months post DBS device implantation.|1 day|6 participants excluded; 3 due to tremor which may alter neural signal, 2 didn't have adequate amount of neural signal for analysis, 1 was lost to follow-up|||Sample Entropy||Standard Deviation|Mean
2616481|NCT01990313|Primary|Change in Resting State Beta Band Power Over Time|We compared the beta band (13-30 Hz) power in the neural signal at the initial programming visit (baseline) and at the 12 month follow-up visit (1 year) after turning off deep brain stimulation therapy. Beta band power is normalized to average beta band power at the initial programming visit. Using a linear mixed model for repeated measures over time, regression beta coefficient was obtained to determine if beta power changed significantly between the initial programming and the 12 month follow-up visit.|Baseline and 1 Year|2 subjects excluded; 1 lost to follow-up, 1 had ECG artifact in neural signal|||regression beta coefficient|||Number
2616482|NCT01990300|Secondary|Changes From Baseline in Fasting Blood Glucose (FBG)|Reported data are changes in fasting blood glucose level from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months).|Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.|||mg/dL||Standard Deviation|Mean
2616483|NCT01990300|Primary|Changes From Baseline in Glycosylated Hemoglobin (HbA1c)|Reported data are changes in HbA1c from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months).|Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percent HbA1c||Standard Deviation|Mean
2616484|NCT01990300|Primary|Number of Participants Who Experience at Least One Adverse Events||Up to 12 Months|The safety analysis set was defined as all participants who were enrolled and completed the study.|||Participants|||Count of Participants
2616485|NCT01990261|Secondary|Overall Survival According to Prior Chemotherapy Treatment.|Prior chemotherapy treatment is presented as reported by the investigators.|Up to 12 months|Analysis was performed on all enrolled participants.|||days||Standard Error|Mean
2616486|NCT01990261|Secondary|Percentage of Participants With Adverse Events (AEs)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 12 months|Analysis was performed on all enrolled participants.|||percentage of participants|||Number
2616487|NCT01990261|Secondary|Overall Survival (OS)|OS is defined as time from first administration of study drug until death from any cause.|Up to 12 months|Analysis was performed on all enrolled participants.|||days||Standard Error|Mean
2616488|NCT01990261|Primary|Progression Free Survival (PFS) at Month 12|PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.|From inclusion up to disease progression or death whichever occurs first (up to 12 months)|Analysis was performed on all enrolled participants.|||days||95% Confidence Interval|Median
2616489|NCT01990261|Primary|Progression Free Survival (PFS) at Month 6|PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first. Disease progression was determined according to local treatment guidelines.|From inclusion up to disease progression or death whichever occurs first (up to 6 months)|Analysis was performed on all enrolled participants.|||days||95% Confidence Interval|Median
2616490|NCT01990261|Primary|Survival Rate at Month 12||Month 12|Analysis was performed on all enrolled participants.|||percentage of participants|||Number
2616491|NCT01990261|Primary|Survival Rate at Month 6||Month 6|Analysis was performed on all enrolled participants.|||percentage of participants|||Number
2616492|NCT01989975|Secondary|Number of Participants With Investigational Device Deficiencies|"Subjects were instructed to report any inadequacies of a medical device including:~Lack of connection between the CareLink Connect device and the Veo pump (Connectivity issues)~Device Battery issue~Device information display issue"|Outcome measured after 15 days of use of the CareLink Connect Device||||Participants|||Count of Participants
2616494|NCT01989975|Primary|Subject Experience After Using the Carelink Connect Device|Subject experience after using the Carelink Connect device was evaluated with questionnaires. Subjects were asked the question: I felt that I had good control over my diabetes. Likert Scale of 1-7 was used in the study to evaluate the question (1 being the the worse, 4 being neutral and 7 being the best).|Outcome measured after 15 days of use of the CareLink Connect Device||||Scores on a Scale||Standard Deviation|Mean
2616495|NCT01989975|Primary|CareLink Connect Activity: % of the Time Per Day When Cellular Connection Was Established|"The overall system connectivity between the pump, the CareLink Connect device, and the CareLink server will be measured. CareLink Connect activity will be measured by:~Date and time of CareLink Connect transmissions~Transmission type and data sent in CareLink Connect transmissions (includes RF messages and history uploads)"|Outcome measured after 15 days of use of the CareLink Connect Device||||percentage of time spent connected||Standard Deviation|Mean
2616496|NCT01989910|Secondary|The Proportion of Treatment Failure at Week 48 for Both Arms.|The proportion of treatment failure, defined as detectable HIV RNA copies copies/mL, at week 48 for both arms.|At week 48 of both arms||||Participants|||Count of Participants
2616497|NCT01989910|Secondary|The Change From Baseline in Cluster of Differentiation 4(CD4) Cell Counts at Week 48 for Both Arms.|The change from baseline in cluster of differentiation 4(CD4) cell counts at week 48 for both arms.|At week 48 of both arms.|||||||
2616498|NCT01989910|Secondary|The Proportion of Patients With Achievement of Less Than 400 HIV RNA Copies Per ml at Week 48 for Both Arms.|Virological response to achieve HIV RNA copies <400 copies/mL at week 48 of both arms.|At week 48 of both arms||||Participants|||Count of Participants
2616499|NCT01989910|Primary|The Proportion of Patients Who Can Achieve of Less Than 20 HIV RNA Copies Per ml at Week 48 of Both Arms.|Virological response to achieve HIV RNA copies <20 copies/mL at week 48 of both arms.|At week 48 of both arms||||Participants|||Count of Participants
2616500|NCT01989793|Secondary|Number of Participants Experiencing Any Amount of Decrease in Frailty|Number of participants experiencing any amount of decrease in frailty score from baseline to Week 24 (i.e., improvement in frailty status)|from baseline to 24 weeks|Compliant completers: participants who continued treatment during the entire 24 week study. and completed the final visit at 24 weeks. 10 out of the 18 participant who were given losartan completed the study and 15 out of 19 who received the placebo participant completed the study.|||Participants|||Count of Participants
2616501|NCT01989793|Secondary|Number of Participants Experiencing Any Amount of Decrease in Frailty|Number of participants experiencing any amount of decrease in frailty score from baseline to Week 16 (i.e., improvement in frailty status)|from baseline to 16 weeks|Compliant completers: participants who continued treatment during the entire 24 week study. and completed the final visit at 24 weeks. 10 out of the 18 participant who were given losartan completed the study and 15 out of 19 who received the placebo participant completed the study.|||Participants|||Count of Participants
2616502|NCT01989793|Secondary|Number of Participants Experiencing Any Amount of Decrease in Frailty|Number of participants experiencing any amount of decrease in frailty score from baseline to Week 8 (i.e., improvement in frailty status)|from baseline to 8 weeks|Compliant completers: participants who continued treatment during the entire 24 week study. and completed the final visit at 24 weeks. 10 out of the 18 participant who were given losartan completed the study and 15 out of 19 who received the placebo participant completed the study.|||Participants|||Count of Participants
2616503|NCT01989793|Primary|Fatiguability|"Fatiguability was tested using bilateral knee extension with an external load equal to 40% of the maximal voluntary contraction force.~Fatiguability was defined as the ratio (expressed as a percentage) of the total work in the last 3 of the 10 repetitions to that of the first 3 of the 10 repetitions, where the total work for n repetitions is defined as the sum of peak torque (FT-LBS) over n repetitions (i.e., last three reps/first three reps). The maximum of the two sides was used in the analysis."|Week 24|Compliant Completers: Participants who discontinued treatment during study but who continued follow-up visits and completed a final visit at 24 weeks.|||percentage of work||Standard Deviation|Mean
2616504|NCT01989793|Primary|Fatiguability|"Fatiguability was tested using bilateral knee extension with an external load equal to 40% of the maximal voluntary contraction force.~Fatiguability was defined as the ratio (expressed as a percentage) of the total work in the last 3 of the 10 repetitions to that of the first 3 of the 10 repetitions, where the total work for n repetitions is defined as the sum of peak torque (FT-LBS) over n repetitions (i.e., last three reps/first three reps). The maximum of the two sides was used in the analysis."|Week 16|Compliant Completers: Participants who discontinued treatment during study but who continued follow-up visits and completed a final visit at 24 weeks.|||percentage of work||Standard Deviation|Mean
2616505|NCT01989793|Primary|Fatiguability|"Fatiguability was tested using bilateral knee extension with an external load equal to 40% of the maximal voluntary contraction force.~Fatiguability was defined as the ratio (expressed as a percentage) of the total work in the last 3 of the 10 repetitions to the total work in the first 3 of the 10 repetitions, where the total work for n repetitions is defined as the sum of peak torque (FT-LBS) over n repetitions (i.e., last three reps/first three reps). The maximum of the two sides was used in the analysis."|Week 8|Compliant Completers: Participants who discontinued treatment during study but who continued follow-up visits and completed a final visit at 24 weeks.|||percentage of work||Standard Deviation|Mean
2616506|NCT01989793|Primary|Change From Baseline in Isokinetic Strength|"Isokinetic Strength was measured by knee extension exercises where bilateral knee concentric strength was measured using a Biodex System 3 dynamometer set at an angular velocity of 30deg/sec through a joint arc from 90 degrees to 30 degrees (0 degrees- full extension).~The change in strength between baseline and week 24 (i.e., baseline minus week 24) was the outcome of the analysis. A negative number indicates a decrease in strength from week 0 to week 24."|Baseline to Week 24|Compliant Completers: Participants who discontinued treatment during study but who continued follow-up visits and completed a final visit at 24 weeks.|||Newton||Standard Deviation|Mean
2616526|NCT01989572|Secondary|5-year Overall Survival Rate|Overall survival is defined as time from randomization to death from any cause, and 5-year overall survival rate is estimated via Kaplan-Meier method.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all randomized patients, regardless of eligibility|||percentage of participants||95% Confidence Interval|Number
2616507|NCT01989793|Primary|Change From Baseline in Isokinetic Strength|"Isokinetic Strength was measured by knee extension exercises where bilateral knee concentric strength was measured using a Biodex System 3 dynamometer set at an angular velocity of 30deg/sec through a joint arc from 90 degrees to 30 degrees (0 degrees- full extension).~The change in strength between baseline and week 16 (i.e., baseline minus week 16) was the outcome of the analysis. A negative number indicates decrease in strength from week 0 to week 16."|Baseline to Week 16|Compliant Completers: Participants who discontinued treatment during study but who continued follow-up visits and completed a final visit at 24 weeks.|||Newton||Standard Deviation|Mean
2616508|NCT01989793|Primary|Change From Baseline in Isokinetic Strength|"Isokinetic Strength was measured by knee extension exercises where bilateral knee concentric strength was measured using a Biodex System 3 dynamometer set at an angular velocity of 30deg/sec through a joint arc from 90 degrees to 30 degrees (0 degrees- full extension).~The change in strength between baseline and week 8 (i.e., baseline minus week 8) was the outcome of the analysis. A negative number indicates that there was a decrease in isokinetic strength from week 0 to week 8."|Baseline to Week 8|Compliant Completers: Participants who discontinued treatment during study but who continued follow-up visits and completed a final visit at 24 weeks.|||Newton||Standard Deviation|Mean
2616509|NCT01989754|Secondary|Cardiovascular (CV) Death|Analyses were using adjudicated events, i.e. CV death events, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. Event rate was estimated based on the time to the first occurrence of the event.|Approximately 3 years|ITT population included all participants who were randomized.|||Events per 1000 patient-years|||Number
2616510|NCT01989754|Secondary|Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure|Analyses were using adjudicated events, that is (i.e.) CV death events or hospitalization due to heart failure, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. Event rate was estimated based on the time to the first occurrence of the event.|Approximately 3 years|ITT population included all participants who were randomized.|||Events per 1000 patient-years|||Number
2616511|NCT01989754|Primary|Progression of Albuminuria|Progression defined as the development of micro-albuminuria (Urine Albumin Creatinine Ratio [UACR] 30 to 300 milligram per gram [mg/g]) or macroalbuminuria (Albumin/creatinine ratio [ACR] of greater than [>] 300 mg/g) in a participant with baseline normoalbuminuria (ACR less than [<] 30 mg/g) or the development of macro-albuminuria in a participant with baseline microalbuminuria with an ACR increase greater than or equal to (>=) 30 percent from baseline. Participants with macroalbuminuria at baseline (ACR>300 mg/g) were excluded from the analysis. Event rate was estimated based on the time to the first occurrence of the event.|Up to 3 years|The intent to treat (ITT) population included all participants who were randomized. Here 'N' signifies number of participants who were evaluable for this endpoint.|||Events per 1000 patient-year|||Number
2616512|NCT01989689|Primary|Vascular Function as Measured by Brachial Artery Flow Mediated Dilation (FMD)|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter − 6 month diameter)/6 month diameter × 100.|6 months||||percentage of brachial artery diameter||Standard Deviation|Mean
2616513|NCT01989689|Primary|Vascular Function as Measured by Brachial Artery Flow Mediated Dilation (FMD)|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter − 3 month diameter)/3 month diameter × 100.|3 months||||percentage of brachial artery diameter||Standard Deviation|Mean
2616514|NCT01989689|Primary|Vascular Function as Measured by Brachial Artery Flow-mediated Dilation (FMD)|Ultrasonography of the brachial artery performed at the bedside using a high-resolution 10-megahertz (MHz) ultrasound transducer before and after suprasystolic inflation of a blood pressure cuff for 5 minutes in the ipsilateral upper arm. Brachial artery FMD was calculated as (hyperemic diameter − baseline diameter)/baseline diameter × 100.|Baseline||||percentage of brachial artery diameter||Standard Deviation|Mean
2616515|NCT01989676|Secondary|Neutralizing Antibodies (Nab) Incidence at Cycle 1 Day 1 Prior to Treatment: Safety Population|Human serum samples testing positive for the presence of ADA (anti-PF-05280014 or anti-trastuzumab-EU) were analyzed for the presence or absence of NAb (neutralizing anti-PF-05280014 or neutralizing anti-trastuzumab-EU antibodies) following a tiered approach using screening and titer determination. All samples at baseline (prior to treatment) or post-treatment were taken prior to dosing. All participants with the exception of 1 participant in the trastuzumab-EU group tested negative for ADA (titer <1.00) from Cycle 1, Day 1 post-treatment through Cycle 17, Day 1. The corresponding NAb result for this Cycle 17, Day 1 ADA positive sample was not yet available; thus, not reported. The number of participants at Baseline (prior to treatment) with a positive NAb sample (titer≥1.48) is provided.|Available data from Baseline to Cycle 17, Day 1 as of the data cutoff date of 24 August 2016, except the EOT visit and unplanned records.|Safety population was used for analysis, including all participants who received at least 1 dose of study drug. “Number of participant analyzed” refers to number of participants included in the evaluated for ADA at each visit.|||Participants|||Number
2616516|NCT01989676|Secondary|Anti-Drug Antibodies (ADA) Incidence: Safety Population|Two sensitive, specific, and semi-quantitative electrochemiluminescent (ECL) immunoassays, 1 for detecting antibodies against PF-05280014 and the other for detecting antibodies against trastuzumab, were used to analyze ADA samples. Serum samples were first screened for ADA. Any samples that were positive in the screening assay were further analyzed to confirm the positive result and determine the antibody titers. All samples were taken prior to dosing. The number of participants with a positive sample (titer≥1.0) is provided.|Available data from Baseline through Cycle 17, Day 1 as of the data cutoff date of 24 August 2016, except the EOT visit and unplanned records.|Safety population was used for analysis, including all participants who received at least 1 dose of study drug. “Number of participants analyzed” refers to number of participants included in the evaluated for ADA at each visit.|||Participants|||Number
2616730|NCT01987609|Secondary|Change in Toll-like Receptor 8 (TLR-8) Expression|RT-PCR techniques will be used to determine expression levels of the TLR-8 in all skin biopsies. The expression levels of this receptor in skin biopsies at week 4 will be compared to the expression levels at baseline.|4 weeks|Data not collected||||||
2616517|NCT01989676|Secondary|Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population|Human PK serum samples were analyzed for concentrations of trastuzumab-EU using a validated, sensitive, and specific ELISA.|Available trough concentrations collected from Cycle 1, Day 1 to Cycle 17, Day 1 as of the data cutoff date of 24 August 2016, except the EOT visit and unplanned records.|PK population was used for analysis, including all participants receiving PF-05280014 or trastuzumab-EU and had no major protocol deviations that influenced PK assessments, and had at least 1 post dose concentration measurement. “Number of participant analyzed” refers to number of participants with measured PK concentrations for each visit.|||µg/mL||Full Range|Median
2616518|NCT01989676|Secondary|Serum Trough (Pre-dose) Concentration of PF-05280014 at Selected Cycles: PK Population|Human PK serum samples were analyzed for concentrations of PF-05280014 using a validated, sensitive, and specific ELISA.|Available trough concentrations collected from Cycle 1, Day 1 to Cycle 17, Day 1 as of the data cutoff date of 24 August 2016, except the EOT visit and unplanned records.|PK population was used for analysis, including all participants receiving PF-05280014 or trastuzumab-EU and had no major protocol deviations that influenced PK assessments, and had at least 1 post dose concentration measurement. “Number of participant analyzed” refers to number of participants with measured PK concentrations for each visit.|||µg/mL||Full Range|Median
2616519|NCT01989676|Secondary|Serum Peak (1 Hour Post End of Infusion) Concentration of Trastuzumab-EU at Selected Cycles: PK Population|Human PK serum samples were analyzed for concentrations of trastuzumab-EU using a validated, sensitive, and specific ELISA.|Available peak PK concentration data collected at Cycle 1, Day 1 and Cycle 5, Day 1 as of the data cutoff date of 24 August 2016|PK population was used for analysis, including all participants receiving PF-05280014 or trastuzumab-EU and had no major protocol deviations that influenced PK assessments, and had at least 1 post dose concentration measurement. “Number of participant analyzed” refers to number of participants with measured PK concentrations for each visit.|||µg/mL||Full Range|Median
2616520|NCT01989676|Secondary|Serum Peak (1 Hour Post End of Infusion) Concentration of PF-05280014 at Selected Cycles: Pharmacokinetics (PK) Population|Human PK serum samples were analyzed for concentrations of PF-05280014 using a validated, sensitive, and specific enzyme-linked immuno-sorbent assay (ELISA).|Available peak PK concentration data collected at Cycle 1, Day 1 and Cycle 5, Day 1 as of the data cutoff date of 24 August 2016|PK population was used for analysis, including all participants receiving PF-05280014 or trastuzumab-EU and had no major protocol deviations that influenced PK assessments, and had at least 1 post dose concentration measurement. “Number of participant analyzed” refers to number of participants with measured PK concentrations for each visit.|||µg/mL||Full Range|Median
2616521|NCT01989676|Secondary|One-year Survival Rate: ITT Population|One-year survival rate was analyzed based on the time from date of randomization to the date of death due to any cause while the participant was on the study. The 95% CI for the median time to event was based on the Brookmeyer and Crowley method. The 95% CI for the hazard ratio was based on the Cox's proportional hazards model.|From the date of randomization until 378 days post-randomization as of the cutoff date of 24 August 2016.|The ITT population was defined as all participants who were randomized to study drug.|||Months||95% Confidence Interval|Median
2616522|NCT01989676|Secondary|Duration of Response (DOR) Per Central Radiology Assessments: ITT Population|DOR was defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of PD, or to death due to any cause in the absence of documented PD, based on the assessments of the central radiology review in accordance with RECIST 1.1. The 95% CI for the median time to event was based on the Brookmeyer and Crowley method. The 95% CI for the hazard ratio was based on the Cox's proportional hazards model.|From the date of randomization until 378 days post-randomization as of the cutoff date of 24 August 2016.|The ITT population was defined as all participants who were randomized to study drug.|||Months||95% Confidence Interval|Median
2616523|NCT01989676|Secondary|One-year Progression-Free Survival (PFS) Rate Derived From Central Radiology Assessments: ITT Population|One (1)-year PFS rate was analyzed based on the time from date of randomization to first documentation of progressive disease (PD), or death due to any cause in the absence of documented PD, based on the assessments of the central radiology review in accordance with RECIST 1.1. The 95% CI for the median time to event was based on the Brookmeyer and Crowley method. The 95% CI for the hazard ratio was based on the Cox's proportional hazards model.|From the date of randomization until 378 days post-randomization as of the cutoff date of 24 August 2016.|The ITT population was defined as all participants who were randomized to study drug.|||Months||95% Confidence Interval|Median
2616524|NCT01989676|Primary|Objective Response Rate (ORR) Derived From Central Radiology Assessments: ITT Population|ORR was defined as the percentage of participants who achieved complete response (CR, complete disappearance of all target lesions with the exception of nodal disease; all target nodes must have decreased to normal size [short axis <10 mm]) or partial response (PR, ≥30% decrease from Baseline of the sum of diameters of all target measurable lesions; the short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions) by Week 25 of the study and confirmed on a follow-up assessment (Week 33±14 days), based on the assessments of the central radiology review in accordance with RECIST 1.1.|From the date of randomization until the cutoff date of 24 August 2016 when all participants had either completed the Week 33 tumor assessment or discontinued study drug earlier than the Week 33 visit.|The ITT population was defined as all participants who were randomized to study drug.|||Percentage of participants||95% Confidence Interval|Number
2616525|NCT01989572|Secondary|5-year Recurrence Free Survival Rate|Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events, and 5-year overall survival rate is estimated via Kaplan-Meier method. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all randomized patients, regardless of eligibility|||percentage of participants||95% Confidence Interval|Number
2617051|NCT01984424|Secondary|Percentage of Participants Who Achieved a Mean LDL-C at Weeks 22 and 24 of Less Than 70 mg/dL||Weeks 22 and 24|Participants randomized and dosed in Part B of the study|||percentage of participants||95% Confidence Interval|Number
2616527|NCT01989572|Secondary|Recurrence Free Survival in HLA-A2 Positive Patients|Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all HLA-A2 positive patients|||months||95% Confidence Interval|Median
2616528|NCT01989572|Secondary|Overall Survival in Human Leukocyte Antigens-A2 (HLA-A2) Positive Patients|Overall survival is defined as time from randomization to death from any cause.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years,up to year 15|all HLA-A2 positive patients|||months||95% Confidence Interval|Median
2616529|NCT01989572|Primary|Recurrence Free Survival|Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all randomized patients, regardless of eligibility|||months||95% Confidence Interval|Median
2616530|NCT01989572|Primary|Overall Survival|Overall survival is defined as time from randomization to death from any cause.|assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15|all randomized patients, regardless of eligibility|||months||95% Confidence Interval|Median
2616531|NCT01989468|Secondary|Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC)|Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC).|From first dose of study treatment to last study visit, up to 3 years|Safety Set, based on Final Analysis. All subjects who took at least one dose of study treatment during the treatment period. A subject with multiple adverse events within a primary system organ class was counted only once in the total row. Deaths up to 28 days after the last dose are included. Only descriptive analysis done.|||Participants|||Count of Participants
2616532|NCT01989468|Secondary|Proportion of Patients With Enthesitis at Week 24 in the Subset of Patients Who Had Enthesitis at Baseline|The presence of Enthesitis was assessed using a validated enthesitis index that uses 6 sites for evaluation of enthesitis: lateral epicondyle humerus L + R, proximal achilles L + R and medial condyle femur. If enthesitis is present at any of the 6 sites, the subject is counted as a subject with enthesitis.|Week 24|The Enthesitis subset of the Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value at Baseline and post-basline, was considered.|||Participants|||Count of Participants
2616533|NCT01989468|Secondary|Proportion of Patients With Dactylitis at Week 24 in the Subset of Patients Who Had Dactylitis at Baseline|The presence of dactylitis was assessed by dactylitis count (number of fingers and toes with dactylitis, with a range of 0-20). If dactylitis is present with any finger or toe, the patient is counted as a patient with dactylitis.|Week 24|The Dactylitis subset of the Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value at Baseline and post-basline, was considered.|||Participants|||Count of Participants
2616534|NCT01989468|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) in Subjects Treated With Secukinumab Versus Placebo at Week 24|The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. In this trial, only the disability dimension was used. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Within each of the 8 categories, only the item indicating the most severe impairment contributes to the category score. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from baseline indicates improvement.|Week 24|The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.|||Unit on a scale||Standard Error|Least Squares Mean
2616535|NCT01989468|Secondary|Percentage of Subjects Achieving a Psoriatic Area and Severity Index 90 (PASI90) Response in Subjects Treated With Secukinumab Versus Placebo at Week 24|PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI90 represents an improvement in the PASI score of at least 90% as compared with baseline.|Week 24|The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.|||Participants|||Count of Participants
2616536|NCT01989468|Secondary|Change From Baseline in Physical Function Component of the Short-form Health Survey (SF-36-PCS) in Subjects Treated With Secukinumab Versus Placebo at Week 24|SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Week 24|The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.|||Unit on a scale||Standard Error|Least Squares Mean
2616537|NCT01989468|Secondary|Proportion of Subjects Achieving a Psoriatic Area and Severity Index 75 (PASI75) Response in Subjects on Secukinumab Versus Placebo at Week 24|PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI75 represents an improvement in the PASI score of at least 75% as compared with baseline.|Week 24|The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.|||Participants|||Count of Participants
2616538|NCT01989468|Secondary|Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing hsCRP) in Subjects Treated With Secukinumab Versus Placebo at Week 24|DAS28-CRP is a measure of disease activity based on 28-Swollen and Tender Joint Count [proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2)], CRP, and the Patient's Global Assessment of disease activity. Values range from 2.0 to 10.0 where higher values mean a higher disease activity. DAS28-CRP < 2.6 is interpreted as remission.|Week 24|The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.|||Unit on a scale||Standard Error|Least Squares Mean
2616539|NCT01989468|Secondary|Proportion of Patients Achieving American College of Rheumatology 50 (ACR50) Response Criteria on Secukinumab Versus Placebo at Week 24|A patient will be considered as improved according the ACR50 criteria if she/he has at least 50% decreases in the swollen and tender joint count, and at least 50% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]|Week 24|The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.|||Participants|||Count of Participants
2616540|NCT01989468|Primary|Proportion of Patients Achieving American College of Rheumatology 20 (ACR20) Response Criteria on Secukinumab Versus Placebo at Week 24|A patient will be considered as improved according the ACR20 criteria if she/he has at least 20% decrease in the swollen and tender joint count, and at least 20% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]|Week 24|The Full Analysis Set (FAS) based on Primary Analysis, which consisted of all participants with an observed value, was considered.|||Participants|||Count of Participants
2616541|NCT01989455|Secondary|Safety and Tolerability of a Single 1000 mg Oral Dose of Deferiprone|The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of oral deferiprone. Note: All subjects in the 1000 mg cohort received active product, including the 2 who had received placebo for the intravenous infusion.|From dosing until 24 hours post-dose|The safety population included all subjects who received study product.|||participants|||Number
2616542|NCT01989455|Secondary|Absolute Bioavailability of Deferiprone|The pharmacokinetic profile was assessed over a 14-hour interval for deferiprone in healthy volunteers who received a single intravenous dose of 1000 mg and then one week later received a single oral dose of 1000 mg deferiprone oral solution. In both cases, blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||μg*h/mL||Standard Deviation|Mean
2616543|NCT01989455|Secondary|Comparison of Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide Between Deferiprone for Infusion and Oral Deferiprone|Cmax was assessed over a 14-hour interval for deferiprone in healthy volunteers who received a single intravenous dose of 1000 mg and then one week later received a single oral dose of 1000 mg deferiprone oral solution. In both cases, blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||μg/mL||Standard Deviation|Mean
2616544|NCT01989455|Primary|Safety and Tolerability of Single Ascending Doses of Deferiprone When Administered by Intravenous Infusion in Healthy Volunteers.|The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of intravenous deferiprone.|From start of intravenous dosing until Day 5 post-dose for all subjects; and from time of oral dose until 24 hours post-dose for subjects who additionally received oral deferiprone|The safety population included all subjects who received study product.|||participants|||Number
2616545|NCT01989455|Primary|The Terminal Elimination Half-life (T1/2el) for Serum Deferiprone and Deferiprone 3-O-glucuronide|T1/2el was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||hour||Standard Deviation|Mean
2616546|NCT01989455|Primary|Area Under the Curve From Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUC0-∞ was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||μg*h/mL||Standard Deviation|Mean
2616561|NCT01989156|Primary|Concentration of S-phenylmercapturic Acid (S-PMA)|Concentrations measured in urine, adjusted for creatinine, at Day 5 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.|||pg/mg creat||95% Confidence Interval|Geometric Mean
2616547|NCT01989455|Primary|Time to Maximum Observed Serum Concentration (Tmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide|"Tmax was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.~The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation)."|14-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||hour||Full Range|Median
2616548|NCT01989455|Primary|Maximum Measured Serum Concentration (Cmax) for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax was assessed over a 14-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers who received single intravenous doses of 500 mg, 1000 mg, 1500 mg, and 2000 mg of intravenous deferiprone. Blood samples were obtained pre-dose and at 0.17, 0.33, 0.50, 0.75, 1, 1.33, 1.67, 2, 2.5, 3, 4, 6, 9, 12, and 14 hours post-dose.|14-hour interval||||μg/mL||Standard Deviation|Mean
2616549|NCT01989208|Other Pre-specified|Assessing Potential Clinical Benefits of SG1002 Administration by Analyzing BNP Levels.|BNP levels were measured for the each subject prior to treatment and after 7 days on each treatment dose, thus representing a change in BNP over the 21 day treatment period. Increased BNP levels are associated with worsening heart failure.|7 days at each dose.|Levels of BNP were recorded at baseline and every 7 days in the placebo group or the SG1002 dose escalation group.|||pg/ml||Standard Error|Mean
2616550|NCT01989208|Secondary|Assessing Changes in Peak Hydrogen Sulfide Levels in Heart Failure Subjects Following SG1002 Administration.|At the start of each dose, blood samples will be obtained and circulating hydrogen sulfide levels will be assessed over a 24 hour period to determine whether SG1002 can overcome the deficits reported in heart failure patients. Peak hydrogen sulfide levels were measured during the first 4 hours post-administration when maximum concentrations of hydrogen sulfide were reached.|24 hours|Heart failure subject (n=6) had baseline levels of hydrogen sulfide recorded at 0, 0.5, 1, 2, 4, 6, 12 and 24 hours after the administration of the first dose of each of the escalating doses of SG1002.|||Free H2S (uM)||Standard Error|Mean
2616551|NCT01989208|Primary|Number of Subjects With Adverse Events|The number of subjects reporting Treatment Emergent Adverse Events at any time during the study period.|Following 7 days of treatment at each of three doses||||participants|||Number
2616552|NCT01989195|Secondary|Heart Rate: SAFETY AND TOLERABILITY OF MANGANESE CONTRAST REAGENT|"SUBJECTS UNDERWENT PRE- AND POST-MRI EKG TESTING TO ASSESS ANY ADVERSE SYMPTOMS OR SIGNS. THE POST EKG WAS PERFORMED AFTER MEMRI SCAN WERE COMPLETE. EKG WAS NOT OBTAINED BEFORE AND AFTER DEMRI.~Measured the difference in heart rate per EKG before and after MEMRI study."|Pre MRI and Post MRI on same day (Day 1)||||Heart Rate change in beats per minute||Standard Deviation|Mean
2616553|NCT01989195|Secondary|Significant Cardiovascular Event|Hospitalization and procedures for chest pain, arrhythmias, and all-cause mortality|1 year||||participants|||Number
2616554|NCT01989195|Secondary|SAFETY AND TOLERABILITY OF MANGANESE CONTRAST REAGENT|"QRS Duration: SUBJECTS UNDERWENT PRE- AND POST-MRI EKG TESTING TO ASSESS ANY ADVERSE SYMPTOMS OR SIGNS. THE POST EKG WAS PERFORMED AFTER MEMRI SCAN WERE COMPLETE. EKG WAS NOT OBTAINED BEFORE AND AFTER DEMRI.~Measured the difference in heart rate per EKG before and after MEMRI study."|Pre MRI and Post MRI on same day (Day 1)||||Change in QRS Duration in milliseconds||Standard Deviation|Mean
2616555|NCT01989195|Primary|COMPARISON OF MYOCARDIAL INFARCTION SIZE MEASUREMENTS USING INVESTIGATIONAL MANGANESE-ENHANCED MRI (MEMRI) OR DELAYED GADOLINIUM ENHANCED MRI (DEMRI)|Measured as percentage of myocardial injury volume to the total left ventricular myocardial volume|Day 1 (1 MRI)||||percentage of infarct to Left Ventricle||Standard Deviation|Mean
2616556|NCT01989169|Primary|Maximum Plasma Concentration (Cmax) of Midazolam|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng/mL||Standard Deviation|Mean
2616557|NCT01989169|Primary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Midazolam|AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*h/ml||Standard Deviation|Mean
2616558|NCT01989169|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of Midazolam|AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last non-zero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*hr/mL||Standard Deviation|Mean
2616559|NCT01989156|Primary|Levels of Carboxyhemoglobin (COHb)|Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Blood measurements performed in the evening of Day 5, for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.|||% of saturation of hemoglobin||95% Confidence Interval|Geometric Mean
2616560|NCT01989156|Primary|Levels of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol (Total NNAL)|Concentrations measured in urine, adjusted for creatinine, at Day 90 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.|90 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.|||pg/mg creat||95% Confidence Interval|Geometric Mean
2616562|NCT01989156|Primary|Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)|Concentrations measured in urine, adjusted for creatinine, at Day 5 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.|||ng/mg creat||95% Confidence Interval|Geometric Mean
2616563|NCT01989156|Primary|Concentration of Monohydroxybutenylmercapturic Acid (MHBMA)|Concentrations measured in urine, adjusted for creatinine, at Day 5 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.|||pg/mg creat||95% Confidence Interval|Geometric Mean
2616564|NCT01989130|Primary|Resolution of Symptoms|Number of patients that report having no symptoms 7 to 10 days after initial encounter|one year|Analysis of patients who completed the 7-10 day follow-up phone call|||Participants|||Count of Participants
2616565|NCT01989130|Primary|Healthcare Cost|To quantify the amount billed to insurance companies and out of pocket expenses for initial encounter|one year|This outcome measure was not measured, as insurance coverage for hospital and physician charges was unavailable.||||||
2616566|NCT01989130|Primary|Health Utilization|Number of participants with visits to healthcare facilities/providers and non-ED related medications purchased in 7-10 days after enrollment|one year|Analysis included patients that responded to the 7-10 day follow-up phone call.|||Participants|||Count of Participants
2616567|NCT01989130|Primary|Percentage of Participants Prescribed Antibiotic Treatment|Measurement of the number and type of antibiotics prescribed to CT/NG + v. CT/NG - in both groups|one year||||percentage of 70 participants|||Number
2616568|NCT01988922|Primary|The Effects of CYP2B6 Genetic Variants on Ketamine Metabolism and Clearance by CYP2B6*6 Hetero or Homozygote Genotype.|Ketamine metabolism, measured as the plasma norketamine/ketamine AUC ratio in CYP2B6*6 carriers (CYP2B6*6 hetero or homozygotes) compared to the wild-type CYP2B6*1/*1 genotype Ketamine, norketamine, and dehydronorketamine concentrations in plasma and urine were determined by enantioselective HPLC tandem mass spectrometry, using solid phase extraction, based on a modification of a published method.|up to 24 hours|3 genotype groups, metabolism measured for both R- and S-ketamine|||ng/ml*hr||Standard Deviation|Mean
2616569|NCT01988857|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (From Day 0 to Day 30)||||Participants|||Count of Participants
2616570|NCT01988857|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days (Days 0-30) post vaccination period||||Participants|||Count of Participants
2616571|NCT01988857|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 4 days (Days 0-3) post vaccination period||||Participants|||Count of Participants
2616572|NCT01988857|Primary|Numbers of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|Within 4 days (Days 0-3) post vaccination period||||Participants|||Count of Participants
2616573|NCT01988779|Secondary|Change in the Total Bacterial Community Following Treatment as Determined by DNA Sequencing.|The bacterial community was determined using a 16S rRNA quantitative PCR processed using Quantitative Insights into Microbial Ecology (QIIME) software, version 1.8 to yield the operational taxonomic units in each subject sample. The scale is bounded at zero with an increasing score indicating a larger number of distinct bacterial species.|14 days after treatment|Data was only collected on the first consecutive 8 randomized participants and had equal numbers in each group|||units on a scale||Standard Deviation|Mean
2616574|NCT01988779|Secondary|Post-treatment Culture Negativity|Post-treatment culture negativity, defined as less than 1+ growth of organisms. A subject is counted '1' if both nares are free of bacterial growth, and '0' if growth is 1+ of more|14 days after treatment||||Participants|||Count of Participants
2616575|NCT01988779|Secondary|Change in Bilateral Endoscopy Findings Using POSE Scores|"The Perioperative Sinus Endoscopy (POSE) instrument is a specific tool to endoscopically assess the sinus cavities of patients who have undergone endoscopic sinus surgery.~Each POSE score has a minimum of 0 and a maximum of 16, with a higher score indicating a worse outcome.~Here, the Left and Right POSE scores are summed and the difference between baseline and the 14 day after treatment is reported.~The change in bilateral POSE score can in principle be -32 to +32, with increased scores indicating worse outcome and negative scores indicating improvement over the treatment period."|14 days after treatment||||units on a scale||Standard Deviation|Mean
2616576|NCT01988779|Secondary|Change in Sino-nasal Outcome Test (SNOT-22) Score|"The Sino-nasal outcome test is a 22-item questionnaire completed by the patient or subject. Each item has a value of zero to five, a higher score indicates a self-perception of worse symptoms. The minimum score is zero and the maximum score is 110.~The difference score here is the post-treatment score minus the pre-treatment score, with lower meaning more improvement"|14 days after treatment||||units on a scale||Standard Deviation|Mean
2616731|NCT01987609|Secondary|Change in Toll-like Receptor 7 (TLR-7) Expression|RT-PCR techniques will be used to determine expression levels of the TLR-7 in all skin biopsies. The expression levels of this receptor in skin biopsies at week 4 will be compared to the expression levels at baseline.|4 weeks|Data not collected.||||||
2616577|NCT01988779|Primary|Change in Rhinosinusitis Disability Index (RSDI) Scores|"The Rhinosinusitis Disability Index is a 30-item questionnaire completed by the patient or subject. Each item has a value of zero to four, a higher score indicates a self-perception of worse symptoms. The minimum score is zero and the maximum score is 120.~The difference score here is the post-treatment score minus the pre-treatment score, with lower meaning more improvement"|14 days after treatment||||units on a scale||Standard Deviation|Mean
2616578|NCT01988662|Primary|Percent Change From Baseline at Month 3 in Plasma VEGF Following Intravitreal (IVT) Injection of Anti-VEGF Agent|Percent change in blood VEGF level is calculated as the difference in blood VEGF level measured after 3 month of anti-VEGF agent IVT treatment (Ranibizumab or Aflibercept) when compared to baseline blood VEGF level.|Change from baseline at Month 3|Full Analysis Set (FAS): The FAS consisted of all randomized patients who received at least one dose of study treatment. FAS was the analysis set. However, patients who were randomized due to erroneous use of the IRT system and who did not receive at least one dose of study treatment were excluded from the FAS.|||Percent change||Standard Error|Least Squares Mean
2616579|NCT01988662|Secondary|Number of Patients With Ocular and Systemic Adverse Events|The incidence of reported treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE).|Day 1 to day 85|Safety (SAF) analysis set: The SAF analysis set included all patients who received at least one dose of study treatment and had at least one post-baseline safety assessment.|||Participants|||Number
2616580|NCT01988662|Secondary|Mean Change From Baseline in Central Retinal Thickness (CRT) of the Study Eye Over Time|"CRT in micrometers assessed by Optical Tomography (OCT) at each single study visit. A reduction is thickness indicates an improvement is the lesion area.~Change from baseline calculated as observed post-baseline - baseline value."|Baseline, month 1, month 2, month 3|FAS: The FAS consisted of all randomized patients who received at least one dose of study treatment. FAS was the analysis set. However, patients who were randomized due to erroneous use of the IRT system and who did not receive at least one dose of study treatment were excluded from the FAS.|||micrometers||Standard Deviation|Mean
2616581|NCT01988662|Secondary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye Over Time|BCVA score is assessed on study eye based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts at a testing distance of 4 meters. An increase in score indicates an improvement in acuity. Change from baseline calculated as observed post-baseline value - baseline value.|Baseline, month 1, month 2, month 3|FAS: The FAS consisted of all randomized patients who received at least one dose of study treatment. FAS was the analysis set. However, patients who were randomized due to erroneous use of the IRT system and who did not receive at least one dose of study treatment were excluded from the FAS.|||Letter||Standard Deviation|Mean
2616582|NCT01988662|Secondary|Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime|VEGF level and anti-VEGF concentration measured in the blood at each single visit, including pre- and post-dose measurement at the dosing visits.|pre-dose to post-dose at Baseline, week 1, week 2, month 1, month 2, and month 3|FAS|||pearson correlation coefficient||95% Confidence Interval|Number
2616583|NCT01988662|Secondary|Percent Change From Baseline in Plasma VEGF Level Overtime|Plasma VEGF measurement performed at all visits and compared to baseline level|Change from baseline up to month 3|FAS: The FAS consisted of all randomized patients who received at least one dose of study treatment. FAS was the analysis set. However, patients who were randomized due to erroneous use of the IRT system and who did not receive at least one dose of study treatment were excluded from the FAS.|||Percent change||Standard Error|Least Squares Mean
2616584|NCT01988493|Secondary|Phase 2: Percentage of Participants With Disease Control Based on Tumor Assessment by Investigator According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) Criteria|Disease control was defined as CR, PR, or stable disease (SD) as the best overall response according to radiological assessments as adjudicated by the IRC from randomization until the first occurrence of PD. CR defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. PD was defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started. Percentage of participants with disease control were reported.|Approximately up to 2.8 years|The mITT analysis set in the Phase 2 part of this study included all participants with MET+ HCC who were randomized to study treatment.|||Percentage of Participants||90% Confidence Interval|Number
2616585|NCT01988493|Secondary|Phase 2: Objective Response Rate (ORR) Based on Tumor Assessment by the Investigator|The objective response rate was defined as the percentage of participants who had achieved CR or PR as the best overall response according to radiological assessments as adjudicated by the investigator from randomization until the first occurrence of PD. CR defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. PD was defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started.|Time from randomization until the first occurrence of PD assessed up to 2.8 years|The mITT analysis set in the Phase 2 part of this study included all participants with MET+ HCC who were randomized to study treatment.|||Percentage of participants||90% Confidence Interval|Number
2616594|NCT01988493|Secondary|Phase 1b: Apparent Volume of Distribution During the Terminal Phase (Vz/f) of Tepotinib|The Vz/f was defined as the theoretical volume in which the total amount of required to uniformly distribute to produce the desired plasma concentration. Apparent volume of distribution after oral dose (Vz/F) was influenced by the fraction absorbed. The Vz/f was calculated by dividing the dose with area under the concentration time curve from time zero to infinity multiplied with terminal elimination rate constant Lambda(z). Vz/f=Dose/AUC(0-inf)* Lambda(z).|Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|The PK analysis included all participants who had received at least 1 dose of Tepotinib and who had provided at least 1 plasma concentration measurement of Tepotinib after the first dose.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2616586|NCT01988493|Secondary|Phase 2: Progression-free Survival (PFS) Based on Tumor Assessment by the Investigator|Progression-free survival (assessed by the Investigator) time was defined as the time in months from randomization to either first observation of radiologically confirmed progression disease by the investigator or occurrence of death due to any cause within 84 days of either randomization or the last tumor assessment. PD is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must also demonstrate an absolute increase of at least 5 mm. PFS was measured using Kaplan-Meier (KM) estimates.|Time from randomization to disease progression or occurrence of death due to any cause within 84 days of either randomization or the last tumor assessment, assessed up to 2.8 years|The mITT analysis set in the Phase 2 part of this study included all participants with MET+ HCC who were randomized to study treatment.|||Months||90% Confidence Interval|Median
2616587|NCT01988493|Secondary|Phase 2: Percentage of Participants With Disease Control Based on Tumor Assessment by IRC According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) Criteria|Disease control was defined as CR, PR, or stable disease (SD) as the best overall response according to radiological assessments as adjudicated by the IRC from randomization until the first occurrence of PD. CR defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. PD was defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started. Percentage of participants with disease control were reported.|Time from randomization until the first occurrence of PD assessed up to 2.8 years|The mITT analysis set in the Phase 2 part of this study included all participants with MET+ HCC who were randomized to study treatment.|||Percentage of participants||90% Confidence Interval|Number
2616588|NCT01988493|Secondary|Phase 2: Objective Response Rate (ORR) Based on Tumor Assessment by the IRC|The objective response rate (ORR) was defined as the percentage of participants who had achieved complete response (CR) or partial response (PR) as the best overall response according to radiological assessments as adjudicated by the IRC from randomization until the first occurrence of PD. CR: Complete Response (CR) defined as disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial response (PR) defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. PD defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum of the diameters of target lesions recorded since treatment started.|Time from randomization until the first occurrence of PD assessed up to 2.8 years|The mITT analysis set in the Phase 2 part of this study included all participants with MET+ HCC who were randomized to study treatment.|||Percentage of participants||90% Confidence Interval|Number
2616589|NCT01988493|Secondary|Phase 2: Time-to-Symptomatic Progression (TTSP)|Time-to-symptomatic progression was defined as time (in months) from first study drug administration to the date of deterioration of symptoms assessed by Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index 8 (FHSI-8) (defined as at least a 4-point increase, i.e., higher score, compared with baseline value), or deterioration to Eastern Cooperative Oncology Group (ECOG) performance score 4, or death. FHSI-8 assesses hepatobiliary cancer symptoms with total score ranges from 0 to 32 (0 = the best quality of life; 32 = the worst quality of life with severe symptoms). ECOG assess participant's performance status on a scale of 0 to 5, where 0=fully active and 5=dead.|Up to 2.8 years|The mITT analysis set in the Phase 2 part of this study included all participants with MET+ HCC who were randomized to study treatment. As per planned analysis, data for this outcome was analyzed only for phase 2 based on combined analysis of both FHSI-8 and ECOG.|||Months||90% Confidence Interval|Median
2616590|NCT01988493|Secondary|Phase 1b: Apparent Terminal Half-life (t1/2) of Tepotinib|Apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50 percent in the final stage of its elimination.|Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|The PK analysis included all participants who had received at least 1 dose of Tepotinib and who had provided at least 1 plasma concentration measurement of Tepotinib after the first dose.|||Hours||Full Range|Median
2616591|NCT01988493|Secondary|Phase 1b: Apparent Terminal Elimination Rate Constant Lambda(z) of Tepotinib|Lambda(z) was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression method.|Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|The PK analysis included all participants who had received at least 1 dose of Tepotinib and who had provided at least 1 plasma concentration measurement of Tepotinib after the first dose.|||1 per hour||Geometric Coefficient of Variation|Geometric Mean
2616592|NCT01988493|Secondary|Phase 1b: Apparent Volume of Distribution During the Steady State (Vss/f) of Tepotinib|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss/f after oral dose was influenced by the fraction absorbed.|Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|The PK analysis included all participants who had received at least 1 dose of Tepotinib and who had provided at least 1 plasma concentration measurement of Tepotinib after the first dose.|||liter||Geometric Coefficient of Variation|Geometric Mean
2616593|NCT01988493|Secondary|Phase 1b: Apparent Total Body Clearance From Plasma (CL/f) of Tepotinib|The CL/f is a measure of the rate at which it was metabolized or eliminated by normal biological processes. Clearance obtained after oral dose was influenced by the fraction of the dose absorbed. The CL/F from plasma was calculated using the formula: Dose divided by area under the concentration time curve from time zero to infinity (AUC0-inf).|Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|The PK analysis included all participants who had received at least 1 dose of Tepotinib and who had provided at least 1 plasma concentration measurement of Tepotinib after the first dose.|||liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2617052|NCT01984424|Secondary|Change From Baseline in LDL-C at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||mg/dL||Standard Error|Least Squares Mean
2616595|NCT01988493|Secondary|Phase 1b: Time to Reach Maximum Plasma Concentration (Tmax) of Tepotinib|Tmax is time to reach maximum observed plasma concentration obtained directly from the concentration versus time curve.|Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|"The PK analysis set was used. Here “Number Analyzed signifies those participants who were evaluable for specified time point."|||Hours||Full Range|Median
2616596|NCT01988493|Secondary|Phase 1b: Average Observed Plasma Concentration (Cav) of Tepotinib|Cavg is the average plasma concentration within 1 dosing interval obtained directly from the concentration versus time curve.|Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 15 of Cycle 1 (each Cycle is 21 days)|"The PK analysis set was used. Here, “Number of participants analyzed signifies those participants who were evaluable for specified time point."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2616597|NCT01988493|Secondary|Phase 1b: Minimum Observed Plasma Concentration (Cmin) of Tepotinib|Cmin is minimum observed plasma concentration obtained directly from the concentration versus time curve.|Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 15 of Cycle 1 (each Cycle is 21 days)|"The PK analysis set was used. Here, “Number of participants analyzed signifies those participants who were evaluable for specified time point."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2616598|NCT01988493|Secondary|Phase 1b: Maximum Observed Plasma Concentration (Cmax) of Tepotinib|Cmax is the maximum observed plasma concentration obtained directly from the concentration versus time curve.|Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|"The PK analysis set was used. Here “Number Analyzed signifies those participants who were evaluable for specified time point."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2616599|NCT01988493|Secondary|Phase 1b: Area Under the Plasma Concentration-Time Curve Within 1 Dosing Interval (AUC 0-tau) of Tepotinib|AUC (0-tau) is the area under the plasma concentration time curve within 1 dosing interval.|Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|"The PK analysis set was used. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and “Number Analyzed signifies those participants who were evaluable at each specified time point."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2616600|NCT01988493|Secondary|Phase 1b: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of Tepotinib|Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration is at or above the lower limit of quantification (LLLQ). AUC(0-t) was calculated according to the mixed log-linear trapezoidal rule.|Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|"The PK analysis set was used. Here, Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and “Number Analyzed signifies those participants who were evaluable at each specified time point."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2616601|NCT01988493|Secondary|Phase 1b: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Tepotinib|The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.|Predose and at 0.25, 0.5, 1, 2, 4, 8, 10, and 24 hours postdose; Day 1 and Day 15 of Cycle 1 (each Cycle is 21 days)|The Pharmacokinetic (PK) analysis included all participants who had received at least 1 dose of Tepotinib and who had provided at least 1 plasma concentration measurement of Tepotinib after the first dose.|||nanogram hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2616602|NCT01988493|Secondary|Phase 2: Time to Progression (TTP) Based on Tumor Assessment by Investigator|TTP was defined as the time in months from randomization to date of the observation of radiological PD (based on RECIST v1.1) assessed by the investigator. PD is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must also demonstrate an absolute increase of at least 5 mm.|From randomization to date of the observation of radiological progressive disease, assessed up to maximum 2.8 years|The mITT analysis set in the Phase 2 part of this study included all participants with MET+ HCC who were randomized to study treatment.|||Months||90% Confidence Interval|Median
2616603|NCT01988493|Secondary|Phase 2: Overall Survival (OS)|Overall survival time was measured as time in months between the date of randomization and the date of death.|Time from randomization to the date of death or up to 2.8 years|The mITT analysis set in the Phase 2 part of this study included all participants with MET+ HCC who were randomized to study treatment.|||Months||90% Confidence Interval|Median
2616604|NCT01988493|Secondary|Phase 2: Progression Free Survival (PFS) Time Based on Tumor Assessment by the Independent Review Committee (IRC)|Progression-free survival (PFS) time was defined as the time in months from randomization to either first observation of disease progression (based on RECIST v1.1) or occurrence of death due to any cause within 84 days of either randomization or the last tumor assessment. PD is defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must also demonstrate an absolute increase of at least 5 millimeter(mm). PFS was measured using Kaplan-Meier (KM) estimates.|Up to 2.8 years|The mITT analysis set in the Phase 2 part of this study included all participants with MET+ HCC who were randomized to study treatment.|||Months||90% Confidence Interval|Median
2616605|NCT01988493|Primary|Phase 2: Time to Progression (TTP) Based on Tumor Assessment by an Independent Review Committee (IRC)|TTP was defined as the time in months from randomization to date of the observation of radiological progressive disease (PD) (based on Response Evaluation Criteria in Solid Tumors [RECIST] v1.1) assessed by an IRC. PD is defined as at least 20 percent (%) increase in sum of diameters of target lesions, taking as reference as smallest sum on study; and/or unequivocal progression of existing non-target lesions and/or the presence of new lesions. The sum must demonstrate an absolute increase of at least 5 millimeter (mm).|From randomization to date of the observation of radiological progressive disease, assessed up to maximum 2.8 years|The modified intent-to treat (mITT) analysis set in the Phase 2 part of this study included all participants with Mesenchymal-epithelial transition (MET)+ hepatocelluar carcinoma (HCC) who were randomized to study treatment.|||Months||90% Confidence Interval|Median
2616606|NCT01988493|Primary|Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs|An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and assessed up to 94 weeks. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline up to Day 30 after the last dose of study treatment, assessed up to 94 weeks|The safety analysis set included all participants who had received any dose of the study medication.|||Participants|||Count of Participants
2616607|NCT01988493|Primary|Phase 1b: Number of Participants Experiencing Dose Limiting Toxicity|Dose limiting toxicity (DLT) was defined as toxicities at any dose level and judged to be related to the study treatment by investigator and/or the sponsor. DLTs included Grade 4 neutropenia for more than 7 days; Grade greater than or equal to (>=) 3 febrile neutropenia for more than 1 day; Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with non-traumatic bleeding; Grade >= 3 uncontrolled nausea/vomiting and/or diarrhea despite adequate and optimal treatment and Grade >= 3 any non-hematological adverse event (AE), except the aforementioned gastrointestinal events and alopecia. Number of participants who experienced DLT during phase 1b were reported.|Day 1 to Day 21 of Cycle 1 (each cycle is 21 days)|Dose Limiting Toxicity (DLT) set included all participants who experienced a DLT during Cycle 1, or received at least 80 percent of all planned doses of treatment during Cycle.|||Participants|||Count of Participants
2616608|NCT01988415|Primary|Percentage of Eyes Losing More Than 2 Lines of Best-corrected Distance Visual Acuity|Primary Safety Outcome Measure: percentage of eyes losing more than 2 lines of best-corrected distance visual acuity|3 Months|The analysis population was all evaluable eyes.|||percentage of eyes|Participants||Number
2616609|NCT01988415|Primary|Mean Postoperative Spherical Aberration|Primary Efficacy Outcome Measure: mean spherical aberration of eyes treated with the VSS-Rx1 OPM treatment planning software compared to that of eyes treated with the commercial iDesign treatment planning software.|3 months|The analysis population was all evaluable eyes.|||µm|Participants|Standard Deviation|Mean
2616610|NCT01988402|Secondary|Serum Uric Acid Level|Blood test (serum) for uric acid level|day 28||||mg/dl||Standard Error|Mean
2616611|NCT01988402|Secondary|Physician Global Assessment of Gout Activity at Day 28|Physician rated gout activity is measured on a Likert scale 0-10.|Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported||||units on a Likert scale||95% Confidence Interval|Mean
2616612|NCT01988402|Secondary|Pain Day 28|Patient rated pain on a Likert pain score of 0-10|Pateints are assessed at five time intervals over 28 days: days 1, 3-4, 10-15, 20-25, and 28; Day 28 reported||||units on a Likert scale||95% Confidence Interval|Mean
2616613|NCT01988402|Primary|Resolution of the Acute Gout Attack|The primary outcome unit of measurement is time (in days) to resolution of the acute gout attack|1-28 Days||||days||Standard Deviation|Mean
2616614|NCT01988376|Primary|the Percentage of Smears, That Were Difficulty in Making a Definite Diagnosis|Comparing the percentage of smears, that were difficulty in making a definite diagnosis from smear owing to insufficient cells, between Surepath® and Conventional Smear in Women after Radiation Therapy for Cervical Cancer|1 year|Patients with cervical cancer who received radiation therapy|||percentage of smears|||Number
2616615|NCT01988129|Secondary|Change Firefighters' and Families' Job Satisfaction and Ability to Cope With Extended Work Hours|In developing the study detail with the department, it became apparent that it would be impractical to assess firefighters' and families' job satisfaction and ability to cope with extended work hours in a meaningful way. We therefore did not address this aim.|Baseline to 12 months|In developing the study detail with the department, it became apparent that it would be impractical to assess firefighters’ and families’ job satisfaction and ability to cope with extended work hours in a meaningful way. We therefore did not address this aim.||||||
2616616|NCT01988129|Secondary|Change in Firefighters' Health, as Determined by General Health Indices;|"The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.~A higher health index is indicative of better health. We assessed general health with the question ' In general, would you say your health is Excellent/Very good/Good/Fair/Poor?' and coded the answers from 5-1, respectively."|Baseline to 12 months|Within-subject pre- versus post-study. Only 97/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.|||units on a scale||Standard Deviation|Mean
2616617|NCT01988129|Secondary|Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Stopped in Traffic|"A lower number of times reported sleeping while stopped in traffic is indicative of better alertness and cognitive performance.~The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.~The analysis for the number of times individuals reported sleeping while stopped in traffic is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 82/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.|||Incidents/month||Standard Deviation|Mean
2616618|NCT01988129|Secondary|Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping While Driving|"A lower number of times reported sleeping while driving is indicative of better alertness and cognitive performance.~The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.~The analysis for the number of times individuals reported being sleepy while driving is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 81/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.|||Incidents/month||Standard Deviation|Mean
2616619|NCT01988129|Other Pre-specified|Number of Participants With Sleep Disorders According to Voluntary Sleep Disorders Screening Questionnaire|Firefighters were instructed to attend a mandatory 30-min education training presentation as operations allowed. Following the education, firefighters were invited and encouraged to complete a voluntary sleep disorders screening questionnaire. This questionnaire used validated, self-report screening tools for Obstructive Sleep Apnea (OSA), moderate to severe insomnia, restless legs syndrome and shift work disorder. All of the respondents who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a local American Academy of Sleep Medicine-certified, partnering sleep clinics if they chose to follow-up. Participants were also free to seek medical follow-up elsewhere. Telephone calls were made to all high risk participants to ensure that they were aware of the results, and to facilitate clinic scheduling. Participants were asked to provide voluntary medical records release consent for tracking diagnoses.|Baseline (Study start)|A total of 431 firefighters completed the sleep disorders screening survey including 416 from the intervention stations and 15 who were temporarily assigned to duty in the intervention stations on the day of the survey. We did not consider these 15 firefighters as a separate population.|||participants|||Number
2616620|NCT01988129|Primary|Firefighters' Performance, as Determined by Response Time Over 12 Months|"A lower response time is indicative of better performance.~Following detailed review of departmental procedures and records, we determined that 'turn-out time' was already very rapid and not considered an accurate measure of firefighters' performance by the department. Similarly, 'clearance time' (time from the start until the end of the event), which could last for many hours, was also not considered an appropriate measure of firefighter' performance in relation to sleep and alertness given the multiple factors, many of which are not under the control of the firefighters, that could affect clearance times. We therefore did not address this aim."|12 months|Following review of departmental records, we determined that ‘turn-out time’ and ‘clearance time’ were not appropriate measures of firefighter’ performance in relation to sleep and alertness given the multiple factors that could affect them. We therefore did not address this aim.||||||
2616621|NCT01988129|Secondary|Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleeping on the Telephone|"A lower number of times reported sleeping on the telephone is indicative of better alertness and cognitive performance.~The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.~The analysis for the number of times individuals reported sleeping on the telephone is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 88/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.|||Incidents/month||Standard Deviation|Mean
2616622|NCT01988129|Secondary|Change in the Mean Alertness and Cognitive Performance of Firefighters - Sleepy During Meetings|"A lower number of times reported falling asleep during meetings is indicative of better alertness and cognitive performance.~The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.~The analysis for the number of times individuals reported sleeping during meetings is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 27/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.|||Incidents/month||Standard Deviation|Mean
2616623|NCT01988129|Secondary|Change in the Mean Total Sleep Time|"A higher total sleep time is indicative of better sleep. The outcome measure was assessed in the intervention group only at the start and end of the program. There are no data for the control group and therefore they have not been added or reported as a separate study arm.~The analysis for total sleep time is limited to those individuals in the intervention stations who participated in the program, completed both the study start and 12-month follow-up survey, and had at least 1 week of work scheduled in the 4 weeks prior to each survey."|Baseline to 12 months|Within-subject pre- versus post-study. Only 62/100 individuals in the intervention group who completed the end-of-year survey responded to this question at both time points.|||Hours/week||Standard Deviation|Mean
2616624|NCT01988129|Primary|Firefighter Safety, as Determined by On-the-job Injuries Over 12 Months|Fewer on-the-job injuries is indicative of better health. We assessed injuries cumulatively over 12 months. Injuries that triggered the filing of an official city government accident report as the result of following normal departmental procedures were included in this study.|12 months||||injury report/firefighter||Standard Deviation|Mean
2616625|NCT01988129|Primary|Firefighter Safety, as Determined by Motor Vehicle Crashes Over 12 Months|Fewer motor vehicle crashes is indicative of better health. We assessed motor vehicle crashes cumulatively over 12 months. Accidents were counted as any incident that resulted in the filing and review of a departmental Fleet Accident Report.|12 months||||incidents/firefighter||Standard Deviation|Mean
2616626|NCT01988129|Primary|Firefighters' Health, as Determined by Number of 'Sick' Days Over 12 Months|We assessed 'sick days' cumulatively over 12 months in two ways from departmental payroll records; the number of 24-hour pay periods coded as 'sick' time per firefighter and the number of 24-hr pay periods coded as injury and disability per firefighter. Fewer sick days is indicative of better health.|12 months||||days/firefighter||Standard Deviation|Mean
2616634|NCT01988103|Secondary|Change From Baseline in Pruritus Visual Analogue Scale 100-mm (VAS) at Week 16|The pruritus visual analog scale (VAS) was used to measure the amount of itching and discomfort a participant experiences. Participant's assessment of pruritus (Itch) asked: On average, how much itch have you had because of your condition in the past week? Higher scores correspond to more severe symptom or disease. The participant places a vertical line on a 100-mm VAS on which the left-hand boundary represents no itch at all and the right-hand boundary represents the worst itch imaginable. The distance from the vertical line to the left-hand boundary is recorded. VAS scores range from 0 to 100 mm, where higher scores correspond to worse pruritis (itch).|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of IP. Participants were included in the treatment group in which they were randomized. Missing values were imputed using the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2616627|NCT01988103|Secondary|Number of Participants With Adverse Events (AE) in the During the Apremilast-exposure Period|An AE was any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|From the first dose of apremilast (either Week 0 or Week 16 for participants originally randomized to placebo who were re-randomized at Week 16) until 28 days after the last dose of apremilast.|All participants who received apremilast at any time during the trial.|||participants|||Number
2616628|NCT01988103|Secondary|Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase|An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.|Baseline to Week 16|Safety population consisted of all participants who were randomized and received at least one dose of IP|||participants|||Number
2616629|NCT01988103|Secondary|Percent Change From Baseline in Physical Function Assessment Using the Health Assessment Questionnaire Disability Index (HAQ-DI)|Change from baseline in physical function assessment using HAQ-DI; The HAQ-DI is a 20-question, self-administered instrument that measures the subject's functional ability on a 4-level difficulty scale (0-3, with 0 representing normal or no difficulty; and 3 representing inability to perform). Eight categories of functioning are included: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities.|Baseline to Week 16|Due to the small sample size for the change from baseline in physical function assessment using the HAQ-DI, the analysis was not conducted. The decision not to perform the analysis was authorized by the lead therapeutic executive and there is no data available to analyze. No resources are available to conduct the analysis for the end point.||||||
2616630|NCT01988103|Secondary|Percent Change From Baseline Psoriatic Arthritis Pain Visual Analogue Scale (VAS)|Change from baseline in psoriatic arthritis pain 100-mm VAS; The participant places a vertical line on a 100-mm VAS on which the left-hand boundary represents no pain at all and the right-hand boundary represents the worst possible pain. The distance from the vertical line to the left-hand boundary is recorded.|Baseline to Week 16|Due to the small sample size in the study for change from baseline in psoriatic arthritis pain VAS, the analysis was not conducted. The decision not to perform the analysis was authorized by the lead therapeutic executive and there is no data to analyze. No resources are available to conduct the analysis for the end point.||||||
2616631|NCT01988103|Secondary|Number of Participants Who Achieved an American College of Rheumatology Criteria (ACR) 20% Improvement (ACR 20)|The ACR 20 is defined as a 20% improvement in joint tenderness (78 joint count) and joint swelling scores (76 joint count) compared to baseline plus 20% improvements in 3 of the following 5 assessments (compared to baseline): subject global assessment of disease activity (measured on a 100-mm visual analog scale [VAS]); physician global assessment of disease activity (measured on a 100-mm VAS); subject self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI] score); subject assessment of pain (measured on a 100-mm VAS); and CRP level.|Baseline to Week 16|Due to the small sample size in the study for the ACR 20 % improvement, the analysis was not conducted. The decision not to perform the analysis was authorized by the lead therapeutic executive and there is no data available to analyze. No resources are available to conduct the ACR 20% improvement endpoint for this population.||||||
2616632|NCT01988103|Secondary|Change From Baseline in Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16|SF-36 is a 36-item general health status instrument often used in clinical trials and health services research. It consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better quality of life (better functioning)|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of IP. Participants were included in the treatment group in which they were randomized.|||units on a scale||Standard Error|Least Squares Mean
2616633|NCT01988103|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16|"Dermatology Life Quality Index (DLQI) was developed as a practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains 10 items dealing with the participants skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if No, then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being A lot, A little, or Not at all (scores 2, 1, or 0 respectively). The DLQI total score has a possible range from 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best."|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of IP. Participants were included in the treatment group in which they were randomized. Missing values were imputed using the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2616635|NCT01988103|Secondary|Percentage of Participants Who Achieved a 50% Improvement From Baseline (Response) Reduction in the PASI-50 at Week 16|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of IP. Participants were included in the treatment group in which they were randomized. Missing values were imputed using the LOCF method.|||percentage of participants|||Number
2616636|NCT01988103|Secondary|Percent Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score|The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. The PASI is a validated instrument that has become standard in clinical trials for psoriasis. The PASI scores range from 0 to 72, with higher scores reflecting a greater disease severity.|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of IP. Participants were included in the treatment group in which they were randomized. Missing values were imputed using the LOCF method.|||percent change||Standard Error|Least Squares Mean
2616637|NCT01988103|Secondary|Percent Change From Baseline in the Psoriasis Affected Body Surface Area (BSA) at Week 16|"BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the subject's hand (entire palmar surface or handprint including the fingers), which equates to approximately 1% of total body surface area."|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of IP. Participants were included in the treatment group in which they were randomized. Missing values were imputed using the LOCF method.|||percent change||Standard Error|Least Squares Mean
2616638|NCT01988103|Secondary|Percentage of Participants Who Achieved a Static Physician's Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Point Reduction From Baseline to Week 16|The sPGA is a measure of psoriasis disease severity at the time of evaluation by the Investigator. It does not compare assessments across visits or rely on investigator recall or prior disease. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examines all of the lesions on the participant and assigns a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equals the overall sPGA score.|Baseline to Week 16|mITT population with a sPGA greater than 2 at baseline. Participants were included in the treatment group in which they were randomized. Missing values were imputed using the LOCF method.|||percentage of participants|||Number
2616639|NCT01988103|Primary|Percentage of Participants Who Achieved a 75% Improvement (Response) From Baseline in the Psoriasis Area and Severity Index (PASI-75) at Week 16|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.|Baseline to Week 16|mITT consisted of all participants who were randomized and received at least one dose of IP. Participants were included in the treatment group in which they were randomized. Missing values were imputed using the Last observation carried forward (LOCF) method.|||percentage of participants|||Number
2616640|NCT01988090|Other Pre-specified|Grip Strength|Exploratory Endpoints For each patient on the study, grip strength will be correlated with AIA score using Spearman correlation at three time points throughout the study - baseline, week 12, and week 52.|52 weeks|||||||
2616641|NCT01988090|Secondary|Association Between Vitamin D Levels Changes and Treatment.|Patients' serum 25-hydroxyvitamin D level were tested at baseline and week 12. The changes between baseline and week 12 were calculated.|12 weeks|Patients who had serum 25-hydroxyvitamin D level tested at baseline and week 12 were included in the analysis.|||ng/mL||Standard Deviation|Mean
2616642|NCT01988090|Secondary|Compliance With Anti-Cancer Treatment|We checked compliance of aromatase inhibitor therapy during the study by reviewing the patient's use of AI drug. This will be done by counting remaining pills in patient's bottles of AI at 52 weeks. A percentage of the number of pills were actually taken of the number of pills should be taken was calculated.|52 Weeks|"Compliance was assessed at week 52. Only 14 patients have compete the data collection.~Form was not completed due to not starting the treatment, or not finishing the treatment, or no source data."|||percentage of pills taken||Standard Deviation|Mean
2616643|NCT01988090|Primary|Number of Participants With Aromatase Inhibitor Induced Arthralgia (AIA) After 12 Weeks of Therapy|Aromatase Inhibitor Arthralgia (AIA) was assessed by a questionnaire that describe the level of pain experienced by the participant. The questionnaire asks 20 questions scored 0-3 in 8 categories of functioning: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. An average composite score on the HAQ-II was calculated. The visual analog scale is the other major component of the HAQ-II, which we ask patients to mark where their pain lies on a horizontal line and we converts the number into a score from 0 to 3. For the purposes of this study, AIA will be defined as any of the following criteria: 1) increase in HAQ-II score from baseline by 0.2 or greater; or 2) increase in visual analog pain score by 0.3 or greater.|12 weeks|ITT population. All patients who were randomized in the study were included in the overall evaluation of response (intent-to-treat analysis).|||Participants|||Count of Participants
2616644|NCT01988012|Secondary|Immunogenicity: Change From Week 1 in Soluble Interleukin-6 Receptor (sIL-6R) Levels|A positive change from Week 1 indicates an increase in sIL-6R levels.|Week 1, Week 12, Week 24, Follow-up Week 32 and Early Withdrawal|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
2616645|NCT01988012|Secondary|Immunogenicity: Tocilizumab Levels||Week 12, Week 24, Follow-up Week 32 and Early Withdrawal|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||microgram/milliliter (mcg/mL)||Standard Deviation|Mean
2616646|NCT01988012|Secondary|Immunogenicity: Percentage of Participants With Anti-tocilizumab Antibodies|Reported is the percentage of participants positive for anti-tocilizumab antibodies in the confirmatory anti-tocilizumab antibody assay, which followed an initial anti-tocilizumab screen. Participants, who withdrew from the study|Baseline, Week 24, Follow-up Week 32 and Early Withdrawal|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||percentage of participants|||Number
2616647|NCT01988012|Secondary|Percentage of Participants Who Required Dose Modifications or Discontinued Study Due to AEs||Up to Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants|||Number
2616648|NCT01988012|Secondary|Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest (AESIs)|An AE is any untoward medical occurrence in a participant administered a drug and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, whether or not considered related to the drug. Preexisting conditions which worsen during a study are also considered as AEs. AESIs are AEs that occur in categories of special interest with regard to the benefit-risk profile and overall safety of a drug. The following nine categories of AESIs were identified for tocilizumab: 1) serious and/or medically significant infections, 2) myocardial infarction/acute coronary syndrome, 3) gastrointestinal perforations, 4) malignancies, 5) anaphylaxis/hypersensitivity reactions, 6) demyelinating disorders, 7) stroke, 8) serious and/or medically significant bleeding events, and 9) serious and/or medically significant hepatic events.|Up to Follow-up Week 32|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants|||Number
2616649|NCT01988012|Primary|Total Scores on Hamilton Depression Rating Scale (HDRS) and Hamilton Anxiety Scale (HAS)|The HDRS is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome. HAS is a clinician-administered assessment to measure the severity of anxiety symptoms and consists of 14 items with a total score range from 0 to 56. A higher score indicates a worse outcome.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2616650|NCT01988012|Primary|Change From Baseline in Patient Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)|The symptom-specific measure FACIT-F assesses chronic illness therapy with special emphasis on fatigue in the past 7 days and consists of 5 dimensions: 1) physical well- being, 2) social/family well-being, 3) emotional well-being, 4) functional well-being, and 5) additional concerns. Each of the questions is categorically answered using the scales 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much for a total possible FACIT-F score of 0 to 52. The figures are reversed during score calculations, so that higher score values indicate more favorable conditions. A positive change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2616651|NCT01988012|Primary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities and 20 questions. Each category contains multiple questions, which were answered using a 4-point scale from 0 (without any difficulty) to 3 (unable to do). The overall index score was an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2616652|NCT01988012|Primary|Change From Baseline in Patient Pain VAS|Patient Pain VAS represents the participant's assessment of his/her current level of pain on a 100 mm horizontal VAS scale from 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2616653|NCT01988012|Primary|Change From Baseline in Patient Global Assessment of Disease Activity Visual Analog Scale (PGA VAS)|PGA VAS represents the participant's overall assessment of their current disease activity on a 100 millimeter (mm) horizontal VAS scale from 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2616654|NCT01988012|Primary|Change From Baseline in Percentage of Participants on Tocilizumab Monotherapy|Participants were either on tocilizumab monotherapy or tocilizumab plus non-biologic disease modifying anti-rheumatic drugs (DMARDs). Reported here is the percentage of participants on tocilizumab monotherapy at baseline and the change from baseline at Week 24. A positive change from baseline at Week 24 indicates the percentage of participants, who discontinued DMARDs during the study.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants|||Number
2616655|NCT01988012|Primary|Change From Baseline in TJC and SJC|The number of tender joints (based on 68 joints) and swollen joints (based on 66 joints) were counted at each visit. TJC was determined by identifying the joints that were painful under pressure or to passive motion; no tenderness =0, tenderness =1. SJC was determined by identifying swelling; no swelling =0, swelling =1. A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||joint count||Standard Deviation|Mean
2616656|NCT01988012|Primary|Percentage of Participants With Good to Moderate European League Against Rheumatism (EULAR) Response|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from the reference visit. Participants with a score lesser than or equal to (</=) 3.2 and reduction of greater than (>) 1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction <=0.6 points, were assessed as non-responders with response recorded as 'none.'|Week 24|The analysis population included those participants from the FAS for whom evaluable data for this outcome measure were available. The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants|||Number
2616657|NCT01988012|Primary|Percentage of Participants Achieving 20%, 50% and 70% Improvement in American College of Rheumatology (ACR) Response Scores (ACR20, ACR50 and ACR70)|An ACR20 response requires at least 20% improvement compared to baseline in SJC (based on 66 joints) and TJC (based on 68 joints) as well as at least 20% improvement in 3 of the following 5 assessments: 1) PGA pain VAS, 2) PGA VAS; 3) physician's global assessment of disease activity VAS, 4) Health Assessment Questionnaire-Disability Index (HAQ-DI) with 20 questions consisting of 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do; and 5) CRP in mg/L or ESR in mm/hr. ACR50 and ACR70 responses are defined in a similar way except that they required a 50% and 70% improvement from baseline, respectively. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity).|Week 24|The analysis population included those participants from the FAS for whom evaluable data for this outcome measure were available. The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants|||Number
2616658|NCT01988012|Primary|Change From Baseline in Disease Activity Score 28-Erythrocyte-Sedimentation Rate (DAS28-ESR)|The DAS28-ESR score is a measure of the patient's disease activity calculated using the tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), patient's global assessment (PGA) of disease activity based on visual analog scale (VAS) and the erythrocyte sedimentation rate (ESR) in millimeter/hour (mm/hr). VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total possible score ranged from 0 to 10. Higher scores represent higher disease activity. A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2616659|NCT01988012|Primary|Change From Baseline in SDAI|Simplified Disease Activity Index (SDAI) was an index for measuring disease activity in RA and had a good correlation with the DAS28. The index was calculated using the following formula: SDAI: SJC28 + TJC28 + PGA (10 cm VAS) + PhGA (10 cm VAS + C-Reactive Protein (CRP) in mg/L. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2616660|NCT01988012|Primary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission and SDAI Low Disease Activity|Simplified Disease Activity Index (SDAI) was an index for measuring disease activity in RA and had a good correlation with the DAS28. The index was calculated using the following formula: SDAI: SJC28 + TJC28 + PGA (10 cm VAS) + PhGA (10 cm VAS + C-Reactive Protein (CRP) in milligram/liter (mg/L). VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. An SDAI score of ≤ 3.3 represents clinical remission, a score of ≤ 11.0 represents low disease activity.|Week 24|The analysis population included those participants from the FAS for whom evaluable data for this outcome measure were available. The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants|||Number
2616661|NCT01988012|Primary|Change From Baseline in CDAI|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. A negative change from baseline indicates an improvement.|Baseline, Week 24|The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here n is the number of participants with evaluable data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2616674|NCT01987908|Secondary|Analgesic Use|Analgesic use assessed with pain levels by numerical pain rating scale (NPRS) and brief pain inventory (BPI).|Throughout the study period (approximately 9 weeks)|Data not collected for this outcome measure. Study terminated early.||||||
2616732|NCT01987609|Secondary|Change in Interferon Alpha (IFNα) Expression|RT-PCR techniques will be used to determine expression levels of the inflammatory cytokine IFNα in all skin biopsies. The expression levels of this cytokine in skin biopsies at week 4 will be compared to the expression levels at baseline.|4 weeks|Data not collected.||||||
2617053|NCT01984424|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 22 and 24||Baselie and weeks 22 and 24|Participants randomized and dosed in Part B of the study|||mg/dL||Standard Error|Least Squares Mean
2616662|NCT01988012|Primary|Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission and CDAI Low Disease Activity|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in rheumatoid arthritis (RA). The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. Remission is defined as CDAI ≤2.8 and Low Disease Activity (LDA) is defined as 2.8< CDAI ≤10.|Week 24|The analysis population included those participants from the full analysis set (FAS) for whom evaluable data for this outcome measure were available. The FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants|||Number
2616663|NCT01987986|Other Pre-specified|Subject Global Assessment of Aesthetic Improvement (C-GAIS)|Subjects's assessment of aesthetic improvement (C-GAIS) scores ranged from 3 to -1 as follows: 3 (very much improved), 2 (much improved), 1 (improved), 0 (no change), -1 (worse).|Day 73|All subjects who received at least one injection of study medication and had at least one post injection efficacy measurement.|||units on a scale||Standard Deviation|Mean
2616664|NCT01987986|Other Pre-specified|Subject Global Assessment Cellulite (SGA-C)|Subjects assessed their cellulite based on a 5-point scale from -1 (slightly worse), 0 (same), 1 (slightly improved), 2 (moderately improved), to 3 (much improved) on Day 73|Day 73|All subjects who at least one injection of study drug and had at least one post-injection efficacy measurement.|||units on a scale||Standard Deviation|Mean
2616665|NCT01987986|Other Pre-specified|Subject Satisfaction With Treatment Assessment (SCTA)|Subjects rated their treatment satisfaction at the Day 73 visit on a 5-point scale ranging from -2 (very dissatisfied) to +2 (very satisfied)|Day 73|All subjects who received at least one injection of study drug and had at least one post -injection efficacy measurement.|||units on a scale||Standard Deviation|Mean
2616666|NCT01987986|Other Pre-specified|Subject-reported Cellulite Impact Scale (SR-CIS)-Change From Baseline|"Subjects were asked to answer 6 exploratory questions regarding the appearance of their cellulite on a scale of 0 to 10 with 0 representing not at all and 10 representing extremely. A SR-CIS total score was derived from these 6 questions with values varying from 0 (No negative impact) to 60 (Extreme negative impact). Change from baseline is Day 73 value minus baseline value; negative change reflects an improvement."|Baseline, Day 73|All subjects who received at least one injection and who had at least one post-injection efficacy measurement.|||units on a scale||Standard Deviation|Mean
2616667|NCT01987986|Other Pre-specified|Subject Global Bother Assessment (SGBA)- Change From Baseline|Subjects rated their cellulite on a scale from 0 (not at all bothered) to 4 (extremely bothered). Change from baseline is Day 73 study visit value minus baseline value; negative change reflects an improvement in the amount the subject was bothered by cellulite; positive change reflects a worsening in the amount the subject is bothered by cellulite.|Baseline, Day 73|All subjects who received at least one injection of study drug and had at least one post-injection efficacy measurement.|||units on a scale||Standard Deviation|Mean
2616668|NCT01987986|Other Pre-specified|Subject Cellulite Severity Item (CSI)-Change From Baseline|CSI scores ranged from 0 (no cellulite present), 1 (very mild), 2 (mild), 3 (moderate), 4 (severe) to 5 (very severe). Change is Day 73 study visit rating minus baseline rating; negative values indicate a lessening in cellulite severity.|Baseline, Day 73|All subjects who received at least one injection of study drug and had at least one post-injection efficacy measurement.|||units on a scale||Standard Deviation|Mean
2616669|NCT01987986|Other Pre-specified|Investigator Cellulite Severity Score (CSS) Total Score- Change From Baseline|The CSS is a photonumeric scale that was used to evaluate 5 morphologic features of cellulite; (A) number of evident depressions, (B) depth of depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or sagging of skin, and (E) current classification scale based on medical literature including Nuernberger and Mueller. The severity of each feature is rated on a scale from 0 (none) to 3 (most severe). The CSS total score is the sum of the 5 cellulite features (range: 0 to 15, with higher scores corresponding to more severe cellulite). Change is Day 73 study visit rating minus baseline rating; negative values indicate improvement in cellulite.|Baseline, Day 73|All subjects who received at least one injection of study drug and had at least one post-injection efficacy measurement.|||units on a scale||Standard Deviation|Mean
2616670|NCT01987986|Primary|Investigator Global Assessment of Aesthetic Improvement|Investigators assessment of aesthetic improvement (I-GAIS) scores ranged from 3 to -1 as follows: 3 (very much improved), 2 (much improved), 1 (improved), 0 (no change), -1 (worse).|Baseline, Day 73|All subjects who received at least one injection of study drug and had at least one post-injection efficacy measurement.|||units on a scale||Standard Deviation|Mean
2616671|NCT01987960|Secondary|Global Clinical Impression Severity of Illness (CGI-S) Score|Clinical Global Impression - Severity of Illness (CGI-S) The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).|Period 2: Baseline to Week 12 (of randomized period)|Due to the low number of enrolled patients eligible for randomization and the sponsor's early termination of the study, the data presented are descriptive i.e. the primary and key secondary efficacy analyses were not done.|||Score||Standard Deviation|Mean
2616672|NCT01987960|Primary|PTSD Symptoms Using CAPS-2 Total Score|Clinician-Administered PTSD Scale Part 2 (CAPS-2): 17 items in criteria B, C and D (Corresponding to CAPS-2) will be administered to provide a total score. They are rated on a 5 point scale for frequency from 0 (never or none) to 4 (daily or almost every day), and intensity from 0 (none) to 4 (extreme). The sum of the 17 items gives a toal score ranging from 0 to 136, with a higher score indicating greater symptom severity.|Period 2: Baseline to Week 12 (of randomized period)|Due to the low number of enrolled patients eligible for randomization and the sponsor's early termination of the study, the data presented are descriptive i.e. the primary and key secondary efficacy analyses were not done|||Score||Standard Deviation|Mean
2616673|NCT01987908|Secondary|Reduction in Sickle Cell-specific Complications||Throughout the study period (approximately 9 weeks)|Data not collected for this outcome measure. Study terminated early.||||||
2616675|NCT01987908|Secondary|Brief Pain Inventory (BPI): Interference of Pain With Aspects of Life (General Activity) During Post-treatment Observation Period - Change From Baseline|"Participants rated the degree to which their pain interfered with various daily functions by using the BPI short form. Interference with general activity was rated on a scale from 0 (does not interfere) to 10 (completely interferes).~Baseline was defined as the most recent value obtained prior to the start of the dosing on Day 1 of the double-blind dosing period."|At baseline and Day 49 during the post-treatment observation period|Participants who provided baseline data and at least one other data point for this outcome measure.|||score on a scale||Standard Deviation|Mean
2616676|NCT01987908|Secondary|Brief Pain Inventory (BPI): Interference of Pain With Aspects of Life (General Activity) During Double-blind Treatment Period - Change From Baseline|"Participants rated the degree to which their pain interfered with various daily functions by using the BPI short form. Interference with general activity was rated on a scale from 0 (does not interfere) to 10 (completely interferes).~Baseline was defined as the most recent value obtained prior to the start of the dosing on Day 1 of the double-blind dosing period.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline, Day 7 and Day 28 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure.|||score on a scale||Standard Deviation|Mean
2616677|NCT01987908|Secondary|Brief Pain Inventory (BPI): Worst Pain Level in Last 24 Hours (Post-treatment Observation Period) - Change From Baseline|"Participants rated the severity of their pain by using the BPI short form. Pain was rated on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain.~Baseline was defined as the most recent value obtained prior to the start of the dosing on Day 1 of the double-blind dosing period."|At baseline and Day 49 during the post-treatment observation period|Participants who provided baseline data and at least one other data point for this outcome measure.|||score on a scale||Standard Deviation|Mean
2616678|NCT01987908|Secondary|Brief Pain Inventory (BPI): Worst Pain Level in Last 24 Hours (Double-blind Treatment Period) - Change From Baseline|"Participants rated the severity of their pain by using the BPI short form. Pain was rated on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain.~Baseline was defined as the most recent value obtained prior to the start of the dosing on Day 1 of the double-blind dosing period.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline, Day 7 and Day 28 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure.|||score on a scale||Standard Deviation|Mean
2616679|NCT01987908|Secondary|Brief Pain Inventory (BPI): Average Pain Level in Last 24 Hours (Double-blind Treatment Period) - Change From Baseline|"Participants rated the severity of their pain by using the BPI short form. Pain was rated on a scale from 0 (no pain) to 10 (pain as bad as you can imagine). A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain.~Baseline was defined as the most recent value obtained prior to the start of the dosing on Day 1 of the double-blind dosing period.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline, Day 7 and Day 28 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure.|||score on a scale||Standard Deviation|Mean
2616680|NCT01987908|Secondary|Numerical Pain Rating Scale (NPRS): Worst Pain (Weekly Average) in the Post-treatment Observation Period - Change From Last Day of Double-blind Treatment Period (Day 28) - AUC|Participants assessed their pain levels by using the 0-10 Numeric Rating Scale: 0 = No pain 1-3 = Mild pain (nagging, annoying, interfering little with activities of daily living [ADLs]) 4-6 = Moderate pain (interferes significantly with ADLs) 7-10 = Severe pain (disabling; unable to perform ADLs A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain. Baseline was defined as the most recent value obtained on the last day of the double-blind dosing period (Day 28). Area under the curve (AUC) was computed using change from baseline (Day 28) in weekly average values at Day 35, Day 42 and Day 49.|Participants assessed and recorded their pain level daily. Weekly averages were calculated for the Day 35, Day 42 and Day 49 assessments||||NPRS score*week||Standard Deviation|Mean
2616681|NCT01987908|Secondary|Numerical Pain Rating Scale (NPRS): Worst Pain (Weekly Average) in the Post-treatment Observation Period - Change From Last Day of Double-blind Treatment Period (Day 28)|"Participants assessed their pain levels by using the 0-10 Numeric Rating Scale: 0 = No pain 1-3 = Mild pain (nagging, annoying, interfering little with activities of daily living [ADLs]) 4-6 = Moderate pain (interferes significantly with ADLs) 7-10 = Severe pain (disabling; unable to perform ADLs A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain. Baseline was defined as the most recent value obtained on the last day of the double-blind dosing period (Day 28).~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Participants assessed and recorded their pain level daily. Weekly averages were calculated for the Day 35, Day 42 and Day 49 assessments||||score on a scale||Standard Deviation|Mean
2616682|NCT01987908|Secondary|Numerical Pain Rating Scale (NPRS): Worst Pain (Weekly Average) in the Post-treatment Observation Period - AUC|Participants assessed their pain levels by using the 0-10 Numeric Rating Scale: 0 = No pain 1-3 = Mild pain (nagging, annoying, interfering little with activities of daily living [ADLs]) 4-6 = Moderate pain (interferes significantly with ADLs) 7-10 = Severe pain (disabling; unable to perform ADLs A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain. Baseline was defined as the average of all measures taken from screening through the period prior to start of dosing on Day 1. Area under the curve (AUC) was computed using change from baseline in weekly average values at Day 7, Day 14, Day 21, Day 28, Day 35, Day 42 and Day 49.|Participants assessed and recorded their pain level daily. Weekly averages were calculated for the Day 35, Day 42 and Day 49 assessments||||NPRS score*week||Standard Deviation|Mean
2616725|NCT01987752|Primary|Percentage of Participants Reporting Adverse Events|An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|Up to 2.6 Years|Safety Population included all participants who received study drug.|||Percentage of participants|||Number
2616683|NCT01987908|Secondary|Numerical Pain Rating Scale (NPRS): Worst Pain (Weekly Average) in the Post-treatment Observation Period - Change From Baseline|"Participants assessed their pain levels by using the 0-10 Numeric Rating Scale: 0 = No pain 1-3 = Mild pain (nagging, annoying, interfering little with activities of daily living [ADLs]) 4-6 = Moderate pain (interferes significantly with ADLs) 7-10 = Severe pain (disabling; unable to perform ADLs A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain. Baseline was defined as the average of all measures taken from screening through the period prior to start of dosing on Day 1.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Participants assessed and recorded their pain level daily. Weekly averages were calculated for the Day 35, Day 42 and Day 49 assessments||||score on a scale||Standard Deviation|Mean
2616684|NCT01987908|Secondary|Numerical Pain Rating Scale (NPRS): Worst Pain (Weekly Average) in the Double-blind Treatment Period - AUC|Participants assessed their pain levels by using the 0-10 Numeric Rating Scale: 0 = No pain 1-3 = Mild pain (nagging, annoying, interfering little with activities of daily living [ADLs]) 4-6 = Moderate pain (interferes significantly with ADLs) 7-10 = Severe pain (disabling; unable to perform ADLs A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain. Baseline was defined as the average of all measures taken from screening through the period prior to start of dosing on Day 1. Area under the curve (AUC) was computed using change from baseline in weekly average values at Day 7, Day 14, Day 21. and Day 28.|Participants assessed and recorded their pain level daily. Weekly averages were calculated for the Day 7, Day 14, Day 21, and Day 28 assessments||||NPRS score*week||Standard Deviation|Mean
2616685|NCT01987908|Secondary|Numerical Pain Rating Scale (NPRS): Worst Pain (Weekly Average) in the Double-blind Treatment Period - Change From Baseline|"Participants assessed their pain levels by using the 0-10 Numeric Rating Scale: 0 = No pain 1-3 = Mild pain (nagging, annoying, interfering little with activities of daily living [ADLs]) 4-6 = Moderate pain (interferes significantly with ADLs) 7-10 = Severe pain (disabling; unable to perform ADLs A negative mean change denotes a pain decrease. A positive mean change denotes an increase in pain. Baseline was defined as the average of all measures taken from screening through the period prior to start of dosing on Day 1.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Participants assessed and recorded their pain level daily. Weekly averages were calculated for the Day 7, Day 14, Day 21, and Day 28 assessments||||score on a scale||Standard Deviation|Mean
2616686|NCT01987908|Secondary|Patients´ Global Impression of Change (PGIC) During the Post-treatment Observation Period - Change From Last Day of Double-blind Treatment Period|"Participants assessed the change in activity limitations, symptoms, emotions, and overall quality of life by using the 1- to 7-point PGIC scale. The question and scale was as follows: Since beginning treatment at this clinic, how would you describe the change in your sickle cell condition? Please circle the number that matches your overall judgment. -3 - much worse -2 - moderately worse -1 - minimally worse 0 - no change +1 - minimally improved +2 - moderately improved +3 - much improved.~Baseline was defined as the most recent value obtained on the last day of the double-blind treatment period.~Categories contain Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline and once weekly on Days 35, 42, and 49 during the post-treatment observation period||||score on a scale||Standard Deviation|Mean
2616687|NCT01987908|Secondary|Patients´ Global Impression of Change (PGIC) During the Post-treatment Observation Period - Change From Baseline|"Participants assessed the change in activity limitations, symptoms, emotions, and overall quality of life by using the 1- to 7-point PGIC scale. The question and scale was as follows: Since beginning treatment at this clinic, how would you describe the change in your sickle cell condition? Please circle the number that matches your overall judgment. -3 - much worse -2 - moderately worse -1 - minimally worse 0 - no change +1 - minimally improved +2 - moderately improved +3 - much improved.~Baseline defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline and once weekly on Days 35, 42, and 49 during the post-treatment observation period||||score on a scale||Standard Deviation|Mean
2616688|NCT01987908|Secondary|Patients´ Global Impression of Change (PGIC) During the Double-blind Treatment Period - Change From Baseline|"Participants assessed the change in activity limitations, symptoms, emotions, and overall quality of life by using the 1- to 7-point PGIC scale. The question and scale was as follows: Since beginning treatment at this clinic, how would you describe the change in your sickle cell condition? Please circle the number that matches your overall judgment. -3 - much worse -2 - moderately worse -1 - minimally worse 0 - no change +1 - minimally improved +2 - moderately improved +3 - much improved.~Baseline defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period. No values available for placebo group for Day 28.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline and once weekly on Days 7, 14, 21, and 28 during the double-blind treatment period||||score on a scale||Standard Deviation|Mean
2616689|NCT01987908|Secondary|Exercise Tolerance: Cardiopulmonary Exercise Test [CPET]|CPET was optional, based on capacity of participant to complete the test.|On last day of double-blind treatment period (Day 28)|Following an external review and report of CPET capabilities of the external service provider, all CPET testing was suspended and the decision made to not collect or analyze CPET data.||||||
2616690|NCT01987908|Secondary|Exercise Tolerance: 6-Minute Walk Distance on Day 49 of the Post-treatment Observation Period - Change From Last Day of Double-blind Treatment Period (Day 28)|Functional exercise capacity was evaluated by using the 6-minute walk test (6MWT) which measures the distance that a subject can quickly walk on a flat, hard surface in a period of 6 minutes. Guidelines developed by the American Thoracic Society were used for conducting the test and interpreting the results.|On last day of double-blind treatment period (Day 28) and on Day 49 of the post-treatment observation period|Participants who provided baseline data and at least one other data point for this outcome measure.|||meters||Standard Deviation|Mean
2616726|NCT01987609|Other Pre-specified|Adverse Events|Any adverse events that subjects have during the course of the study will be recorded at each visit.|3 weeks|||||||
2616691|NCT01987908|Secondary|Exercise Tolerance: 6-Minute Walk Distance on Day 49 of the Post-treatment Observation Period - Change From Baseline|"Functional exercise capacity was evaluated by using the 6-minute walk test (6MWT) which measures the distance that a subject can quickly walk on a flat, hard surface in a period of 6 minutes. Guidelines developed by the American Thoracic Society were used for conducting the test and interpreting the results.~Baseline defined as the most recent value obtained prior to the start of dosing on Day 1."|Prior to dosing at baseline and on Day 49 of the post-treatment observation period|Participants who provided baseline data and at least one other data point for this outcome measure.|||meters||Standard Deviation|Mean
2616692|NCT01987908|Secondary|Exercise Tolerance: 6-Minute Walk Distance During the Double-blind Treatment Period - Change From Baseline|"Functional exercise capacity was evaluated by using the 6-minute walk test (6MWT) which measures the distance that a subject can quickly walk on a flat, hard surface in a period of 6 minutes. Guidelines developed by the American Thoracic Society were used for conducting the test and interpreting the results.~Baseline defined as the most recent value obtained prior to the start of dosing on Day 1.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 4, Day 7, Day 14 and Day 28||||meters||Standard Deviation|Mean
2616693|NCT01987908|Secondary|Body Weight - Change From Baseline|"A negative change in body weight denotes a weight decrease, a positive change in body weight denotes a weight increase.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 1, Day 4, Day 7, Day 14, Day 21 and Day 28||||kg||Standard Deviation|Mean
2616694|NCT01987908|Secondary|N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) Levels- Change From Baseline|Category title includes number of participants with available data (n) for participants treated with study product.|At baseline, Day 1, Day 7, Day 14 and Day 28 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure. Summary tables for placebo group not done as data not collected. Study terminated early.|||pmol/L||Standard Deviation|Mean
2616695|NCT01987908|Secondary|Serum Ferritin Levels - Change From Baseline||At baseline, Day 1 and Day 7 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure. Summary tables for placebo group not done as data not collected. Study terminated early.|||mircograms/L||Standard Deviation|Mean
2616696|NCT01987908|Secondary|C Reactive Protein Levels - Change From Baseline|Category title includes number of participants with available data (n) for participants treated with study product.|At baseline, Day 1 and Day 7 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure. Summary tables for placebo group not done as data not collected. Study terminated early.|||mg/L||Standard Deviation|Mean
2616697|NCT01987908|Secondary|LDH Isoform - Change From Baseline||Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 1, Day 7, Day 14 and Day 28|Summary tables for this outcome measure were not done as baseline data missing. Study terminated early.||||||
2616698|NCT01987908|Secondary|Direct Bilirubin - Change From Baseline|Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo.|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 1, Day 7, Day 14, Day 21 and Day 28||||mircomoles/L||Standard Deviation|Mean
2616699|NCT01987908|Secondary|Reticulocyte Percent- Change From Baseline|Category title includes number of participants with available data (n) for participants treated with study product.|At baseline, Day 1 and Day 7 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure. Summary tables for placebo group not done as data not collected. Study terminated early.|||percent||Standard Deviation|Mean
2616700|NCT01987908|Secondary|Hemoglobin Levels - Change From Baseline|"A clinical laboratory endpoint that reflects the amount of red blood cells present in the blood. Baseline defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 1, Day 4, Day 7, Day 14, Day 21 and Day 28||||g/L||Standard Deviation|Mean
2616701|NCT01987908|Secondary|Lactate Dehydrogenase (LDH) Levels - Change From Baseline|"LDH levels were measured as a biomarker for intravascular hemolysis. The results are based on the LDH Total measurement. Baseline defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 1, Day 7, Day 14 and Day 28||||U/L||Standard Deviation|Mean
2616702|NCT01987908|Secondary|Hematocrit Levels - Change From Baseline|"Baseline defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 1, Day 7, Day 14 and Day 28||||L/L||Standard Deviation|Mean
2616703|NCT01987908|Secondary|Plasma Erythropoietin (EPO) Levels - Change From Baseline|"Erythropoietin (EPO) is a hormone produced by the kidney that promotes the formation of red blood cells by the bone marrow. EPO can be detected and measured in the blood.~Baseline defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|At baseline and Day 28 during the double-blind treatment period|Participants who provided baseline data and at least one other data point for this outcome measure.|||U/L||Standard Deviation|Mean
2616727|NCT01987609|Other Pre-specified|Adverse Events|Any adverse events that subjects have during the course of the study will be recorded at each visit.|2 weeks|||||||
2616704|NCT01987908|Secondary|Oxygen Binding p50/p20 Value - Change From Baseline|"A measure of the ability of hemoglobin to bind oxygen. The p50 is the oxygen level at which 50% of the hemoglobin contains oxygen. The p20 is the oxygen level at which 20% of the hemoglobin contains oxygen. Baseline is defined as the most recent value obtained prior to start of dosing on Day 1 of the double-blind treatment period.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|During the double-blind treatment period at baseline, Day 1, Day 4 and Day 7||||ratio||Standard Deviation|Mean
2616705|NCT01987908|Secondary|Resting Oxygen Saturation as Measured by Oximetry (SpO2) - Change From Baseline|"A measure of the amount of oxygen in the blood. Oxygen saturation was determined by pulse oximetry. A pulse oximeter was placed over a nail polish-free finger nail to determine peripheral oxygen saturation (SpO2).~Baseline was defined as the most recent value obtained prior to the start of dosing on Day 1 of the double-blind treatment period. A mean change from baseline >0 indicates an increase in oxygen saturation, a mean change <0 indicates a decrease in oxygen saturation.~Category title includes number of participants with available data (n) for participants treated with study product, followed by participants treated with placebo."|Prior to, during and after the end of dosing in the double-blind treatment period, i.e., at baseline, Day 4, Day 7, Day 14 and Day 28||||percent saturation||Standard Deviation|Mean
2616706|NCT01987908|Primary|PK: - Plasma AUC, Cmax, Tmax, and T1/2 of Aes-103 and Its Metabolite, HMFA - RBC Hemolysate AUC (0-8h), Cmax, Tmax, and T1/2 of Aes-103 - Percentage of Hemoglobin Bound to Aes-103|"Pharmacokinetic endpoints in the study protocol were as follows:-~Plasma Area under curve (AUC), Maximum plasma concentration (Cmax), time at which Cmax observed (Tmax), and terminal half-life (T1/2) of Aes-103 and its metabolite, 5-hydroxymethyl-2-furoic acid (HMFA)~red blood cell (RBC) hemolysate Area under curve between 0 and 8 hours (AUC [0-8h]), Cmax, Tmax, and T1/2 of Aes-103~Percentage of hemoglobin bound to Aes-103"|PK blood samples were to be taken within 10 minutes before dosing and 0.5, 1, 2, 4, and 6 hours after the first dose of study product on Days 1 and 7 and at the same time points on Day 28 (or early termination)|PK data were not determined as the assay collection method was found to be faulty rendering all samples unevaluable.||||||
2616707|NCT01987908|Primary|Number of Clinically Significant Observations of Vital Signs, 12-lead ECGs, Clinical Laboratory Assessments, and Physical and Neurological Examinations|Vital signs, 12-lead ECGs, clinical laboratory assessments, and physical and neurological examinations that were deemed clinically significant by the investigator in agreement with the sponsor study director.|Throughout the study period (approximately 9 weeks)|safety analysis dataset|||clinically significant observations|||Number
2616708|NCT01987908|Primary|Number of Participants With Sickle-Cell Disease-related Symptoms||Placebo lead-in period of 14 days (Day -14 to Day -1), double-blind treatment period of 28 days (Day 1 to Day 28) and post-treatment observation period of 21 days (Day 29 to Day 49)||||participants|||Number
2616709|NCT01987908|Primary|Number of Participants With Adverse Events, Including Sickle-cell Specific Symptoms, During the Post-treatment Observation Period|Number of participants with adverse events (AEs) reported during the post-treatment observation period. AEs included clinically-significant changes in vital signs, ECG, clinical laboratory assessments, physical and neurological examinations. Sickle cell-specific symptoms included the development of new skin ulcers, hospitalization or ambulatory acute care, intravenous analgesics visit for pain episodes (i.e., sickle-cell disease related pain), acute chest syndrome, priapism, and stroke.|Post-treatment observation period of 21 days (Day 29 to Day 49)||||participants|||Number
2616710|NCT01987908|Primary|Number of Participants With Adverse Events, Including Sickle-cell Specific Symptoms, During the Placebo lead-in Period|Number of participants with adverse events (AEs) reported during the placebo lead-in period. AEs included clinically-significant changes in vital signs, ECG, clinical laboratory assessments, physical and neurological examinations. Sickle cell-specific symptoms included the development of new skin ulcers, hospitalization or ambulatory acute care, intravenous analgesics visit for pain episodes (i.e., sickle-cell disease related pain), acute chest syndrome, priapism, and stroke.|Placebo lead-in period of 14 days (Day -14 to Day -1)||||participants|||Number
2616711|NCT01987908|Primary|Number of Participants With Adverse Events, Including Sickle Cell-specific Symptoms, During the Double-blind Treatment Period|Number of participants with adverse events (AEs) reported during the double-blind treatment period. AEs included clinically-significant changes in vital signs, ECG, clinical laboratory assessments, physical and neurological examinations. Sickle cell-specific symptoms included the development of new skin ulcers, hospitalization or ambulatory acute care, intravenous analgesics visit for pain episodes (i.e., sickle-cell disease related pain), acute chest syndrome, priapism, and stroke.|Double-blind treatment period of 28 days (Day 1 to Day 28)||||participants|||Number
2616712|NCT01987895|Other Pre-specified|Recurrence Rate|Recurrence is defined as the occurrence of a new episode of diarrhea (> 3 unformed bowel movements on any day between end-of-treatment + 3 days and end-of-treatment + 30 days ) Recurrence rates is the percentage of subjects assessed as having a recurrence out of subjects with Clinical Cure.|Between Day 13 and Day 40 on average (from end-of-treatment + 3 days and end-of-treatment + 30 days)|Subjects from the modified intent-to-treat analysis set with clinical cure|||percentage of participants||95% Confidence Interval|Number
2616713|NCT01987895|Other Pre-specified|Sustained Cure Rate (SCR) in the Per-protocol Population|Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The analyses performed on the modified intent-to- treat set (mITT) are repeated on the per-protocol set (PPS) for sensitivity.|Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)|All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD and without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable.|||Percentage of participants||95% Confidence Interval|Number
2616714|NCT01987895|Other Pre-specified|Investigator's Assessment of Sustained Response Rate (ISR Rate) at Visit 5|"ISR rate (%) is the percentage of subjects assessed as Sustained Cure at Visit 5, according to the investigator's own judgement. Sustained Cure is defined for each subject having Clinical Cure and no recurrence. Subjects with missing assessment are considered as having 'Not Sustained Cure' for the analysis.~ISR rate is used as a supportive measure of the secondary efficacy endpoint (SCR). Analyses are performed on the modified intent-to-treat set (mITT)."|Between Day 38 and Day 42 on average (end-of-treatment + 28 to 32 days)|All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD.|||Percentage of participants||95% Confidence Interval|Number
2616715|NCT01987895|Other Pre-specified|Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Per-protocol Population|ICR rate (%) is the percentage of subjects with clinical response assessed as cured according to the investigator's own judgement. ICR rate (%) is the percentage of subjects with ICR assessed as cured. Subjects with missing assessment are considered as not cured for the analysis. ICR rate is used as a supportive measure of the primary efficacy endpoint (CCR). Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below.|Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)|All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD and without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable.|||Percentage of participants||95% Confidence Interval|Number
2616716|NCT01987895|Other Pre-specified|Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Modified Intent-to-treat Population|ICR rate (%) is the percentage of subjects with clinical response assessed as cured according to the investigator's own judgement. Subjects with missing assessment are considered as not cured for the analysis. ICR rate is used as a supportive measure of the primary efficacy endpoint (CCR). Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below.|Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)|All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD.|||Percentage of participants||95% Confidence Interval|Number
2616717|NCT01987895|Secondary|Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores|CDI-DaySyms PRO is a questionnaire assessing 10 symptoms relevant to subjects with CDAD and grouped into 3 domains: Diarrhea symptoms, Abdominal symptoms and Systemic/Other. The subjects rate the severity of each item as None, Mild, Moderate, Severe or Very severe, converted to numeric scores from 0 to 4, respectively. The daily domain score is calculated as the mean of the non-missing responses for that domain on that day. A negative value for change from baseline corresponds to an improvement in domain score. The three domains are evaluated in a hierarchical manner, starting with Diarrhea Symptoms, then Abdominal Symptoms, and finally Systemic/Other Symptoms. The least squares means (LSM) are computed on the scores.|Day 1 (baseline) and Day 3|All subjects from the modified intent-to-treat population, excluding those who participated in the validation sub-study. No imputation of missing scores is performed prior to deriving response status. Subjects with missing values at baseline or at Day 3 are considered to be non-responders.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2616718|NCT01987895|Secondary|Kaplan-Meier Estimates for Resolution of Diarrhea|"Resolution of Diarrhea (ROD) is defined as no more than 3 unformed bowel movements per day for at least two consecutive days for subjects on study treatment.~The Kaplan-Meier estimates (KM estimates) for having an event (ROD) are reported for each time point."|Up to Day 10|The analyses were performed on the modified intention-to-treat population: all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD|||KM estimate (%)||95% Confidence Interval|Number
2616719|NCT01987895|Secondary|Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population|Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The main analysis is performed on the modified intent-to-treat set (mITT).|Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)|All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD.|||Percentage of participants||95% Confidence Interval|Number
2616720|NCT01987895|Primary|Clinical Cure Rate (CCR) in the Per-protocol Population|Clinical Cure (CC) is defined as: • Resolution of Diarrhea (≤ 3 unformed bowel movement per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant between first dose of study drug and 2 days after EOT. CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below.|Up to Day 12 on average (end-of-treatment + 2 days)|All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD and without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable.|||Percentage of participants||95% Confidence Interval|Number
2616721|NCT01987895|Primary|Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population|"Clinical Cure (CC) is defined as: • Resolution of Diarrhea (≤ 3 unformed bowel movement per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant between first dose of study drug and 2 days after EOT.~CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below."|Up to Day 12 on average (end-of-treatment + 2 days)|All subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD.|||Percentage of participants||95% Confidence Interval|Number
2616722|NCT01987765|Primary|Change From Baseline in Eye Symptoms Total Score on a 4-Point Scale|Itchiness, conjunctival hyperaemia (redness), lacrimation (tearing), and foreign body sensation were each evaluated on a 4-point scale ranging from 0 (best) to 3 (worst). The eye symptom total score is the sum of the individual symptom scores and ranges from 0 (best) to 12 (worst). A negative number change from baseline indicates an improvement.|Baseline, 2 Weeks|Efficacy Assessment Population: included all patients in the Safety Assessment Population whose data was available for analysis.|||Scores on a Scale||Standard Deviation|Mean
2616723|NCT01987765|Primary|Percentage of Patients Reporting Adverse Events|An adverse event is any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|Up to 10 Months|Safety Assessment Population: included all patients who completed the study.|||Percentage of Patients|||Number
2616724|NCT01987752|Primary|Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. The study doctor classified the overall improvement of the IOP change from Baseline into 3 categories: Improvement (effective), No Change or Exacerbation (ineffective). The percentage of participants with Improvement is reported.|Baseline, Week 4|Efficacy Population included all participants who received study drug for > 4 weeks and had overall assessment data available.|||Percentage of participants|||Number
2616733|NCT01987609|Secondary|Change in Tumor Necrosis Factor Alpha (TNFα) Expression|RT-PCR techniques will be used to determine expression levels of the inflammatory cytokine TNFα in all skin biopsies. The expression levels of this cytokine in skin biopsies at week 4 will be compared to the expression levels at baseline.|4 weeks|Data not collected||||||
2616734|NCT01987609|Secondary|Change in Histologic Appearance of Psoriatic Plaques|The histologic appearance of a skin biopsy taken from each of the plaques of interest at the end of the study (4 weeks) will be compared to biopsies taken at baseline. The most important feature to be observed is the number of dendritic cells in the different biopsy specimens.|baseline and 4 weeks|Visual data was collected on CD123 staining of dendritic cells in two subjects. Data on the number of dendritic cells were not collected. Further histology/staining was not done given no significant difference was observed in primary endpoint of clinical improvement at interim analysis.||||||
2616735|NCT01987609|Secondary|Physician Global Assessment (PGA)|The Physician Global Assessment (PGA) of the psoriatic plaques of interest will be measured and compared to baseline values on a 0-5 scale where 0 is no evidence of erythema, induration, or scaling, and 5 is severe evidence of these symptoms.|1 week||||units on a scale|psoriatic plaque|Standard Deviation|Mean
2616736|NCT01987609|Secondary|Physician Global Assessment (PGA)|The Physician Global Assessment (PGA) of the psoriatic plaques of interest will be measured and compared to baseline values on a 0-5 scale where 0 is no evidence of erythema, induration, or scaling, and 5 is severe evidence of these symptoms.|2 weeks||||units on a scale|plaques|Standard Deviation|Mean
2616737|NCT01987609|Secondary|Physician Global Assessment (PGA)|The Physician Global Assessment (PGA) of the psoriatic plaques of interest will be measured and compared to baseline values on a 0-5 scale where 0 is no evidence of erythema, induration, or scaling, and 5 is severe evidence of these symptoms.|3 weeks||||units on a scale|psoriatic plaque|Standard Deviation|Mean
2616738|NCT01987609|Secondary|Plaque Area|A ruler/measuring tape will be used to measure the area of the subject's psoriatic plaques of interest.|1 weeks||||centimeter^2||Standard Deviation|Mean
2616739|NCT01987609|Secondary|Plaque Area|A ruler/measuring tape will be used to measure the area of the subject's psoriatic plaques of interest.|3 weeks||||centimeter^2||Standard Deviation|Mean
2616740|NCT01987609|Secondary|Plaque Area|A ruler/measuring tape will be used to measure the area of the subject's psoriatic plaques of interest.|2 weeks||||centimeter^2|Arms|Standard Deviation|Median
2616741|NCT01987609|Secondary|Plaque Area|A ruler/measuring tape will be used to measure the area of the subject's psoriatic plaques of interest.|4 weeks||||centimeter^2|arms|Standard Deviation|Mean
2616742|NCT01987609|Primary|Psoriasis Area Severity Index|The Psoriasis Area Severity Index (PASI) of the psoriatic plaques of interest will be measured and compared to baseline values. The PASI is the most widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).|4 weeks||||score on a scale|arms|Standard Deviation|Median
2616743|NCT01987583|Primary|Diastolic Blood Pressure After 4 Weeks||1 month||||mmHg||Standard Deviation|Mean
2616744|NCT01987583|Secondary|Incidence of Wet Cupping Side Effects in Intervention Group|"Immediate side effects of wet cupping will be assessed through a checklist on the after each cupping session.~Delayed side effects of wet cupping will be assessed through another checklist after 1 month of the final hijama session."|1 month|||||||
2616745|NCT01987583|Primary|Systolic Blood Pressure After 4 Weeks||1 month||||mmHg||Standard Deviation|Mean
2616746|NCT01987557|Secondary|Static Posturography (Balance/Postural Control)|A Balance SD system from BIODEX (Shirley, NY) will be used to assess postural control. Changes from pre to post are what is being examined.|pre test occurs within the week prior to the start of the treadmill training program. Post testing will occur during the week immediately following the 6 week treadmill training program.|||||||
2616747|NCT01987557|Secondary|Spatiotemporal Aspects of Gait|"Participants will walk on a pressure sensitive GAITRite carpet (Sparta, NJ), at both comfortable and fast paced walking speeds. Changes in gait characteristics from pre to post are what is being examined.~Quantitative measures of gait such as step time, step length, walking velocity, and others will be used in the analysis.~Spotters are always present to ensure safety during this assessment."|pre test occurs within the week prior to the start of the treadmill training program. Post testing will occur during the week immediately following the 6 week treadmill training program.|||||||
2616748|NCT01987557|Primary|Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III)|"A measure of the motor symptom severity within Parkinsons. UPDRS III is a qualitative assessment performed by a trained clinician. Specifically, a change in UPDRS III from pre to post is the main outcome measure.~The UPDRS-III score is a summation of 27 tasks that are scored from 0-4. 0 meaning no impairment, and 4 representing extreme impairment, inability to complete task. Possible scores on the UPDRS-III range from 0 (no impairment) to 108 (extreme impairment)."|Pre assessments are conducted in the week prior to the treadmill program. Post are conducted during the week immediately following the program. Changes after the 6 week treadmill program are being examined||||units on a scale (0-4)||Standard Deviation|Mean
2616749|NCT01987505|Secondary|Treatment Response Rate|Treatment response rate was classified according to the International Working Group (IWG) response criteria: CR/Cru, partial response (PR), stable disease (SD) and PD. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus > 75% decrease in residual lymph node mass, indeterminate bone marrow; PR: >/= 50% decrease lymph nodes and nodal mass size; decrease in liver/spleen size, no new sites; SD: less than a PR, but is not PD; PD: >/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.|4-6 weeks after the last dose of Induction (Up to approximately 8 months)|ITT population included all enrolled participants.|||percentage of participants|||Number
2616779|NCT01987479|Primary|Percentage of Participants With Adverse Events|An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events included serious as well as non-serious adverse events.|Baseline up to Week 32|FAS population|||percentage of participants|||Number
2617054|NCT01984424|Primary|Percent Change From Baseline in LDL-C at Week 24||Baseline and week 24|Participants randomized and dosed in part B of the study|||percent change||Standard Error|Least Squares Mean
2616750|NCT01987505|Secondary|Disease-Free Survival (DFS)|DFS was assessed in participants achieving complete response (CR) including complete response unconfirmed (Cru) and was defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus > 75% decrease in residual lymph node mass, indeterminate bone marrow. Reported here is the truncated mean estimate based on Kaplan-Meier analysis.|From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)|ITT population included all enrolled participants.|||months||95% Confidence Interval|Mean
2616751|NCT01987505|Secondary|Overall Survival (OS)|OS was defined as the time from first dose of rituximab IV to death from any cause.|From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)|ITT population included all enrolled participants.|||months||95% Confidence Interval|Mean
2616752|NCT01987505|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from first dose of rituximab IV to the first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or death from any cause. PD: >/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.|From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)|ITT population included all enrolled participants.|||months||95% Confidence Interval|Mean
2616753|NCT01987505|Secondary|Event-Free Survival (EFS)|EFS was defined as the time from first dose of rituximab IV to first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or initiation of a non-protocol-specified anti-lymphoma therapy or death, whichever occurs first. PD: >/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.|From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)|Intent-to-Treat (ITT) population included all enrolled participants.|||months||95% Confidence Interval|Mean
2616754|NCT01987505|Secondary|Percentage of Participants With At Least One Serious Adverse Event (SAE)|SAE was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.|From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)|Safety Population included all enrolled participants who received at least one dose of study medication.|||percentage of participants|||Number
2616755|NCT01987505|Secondary|Percentage of Participants With At Least One Grade >/= 3 Infusion/ Injection Related Reactions (IIRRs)|Grading of IIRRs was completed according to the CTCAE, version 4.0.|From start of treatment to end of treatment (up to 32 months)|Safety Population included all enrolled participants who received at least one dose of study medication.|||percentage of participants|||Number
2616756|NCT01987505|Secondary|Percentage of Participants With At Least One Grade >/= 3 Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events. Grading was completed according to the CTCAE, version 4.0.|From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)|Safety Population included all enrolled participants who received at least one dose of study medication.|||percentage of participants|||Number
2616757|NCT01987505|Primary|Percentage of Participants With Administration-Associated Reactions (AARs)|AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab SC administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.|From start of treatment to end of treatment (up to 32 months)|Safety Population included all enrolled participants who received at least one dose of study medication.|||percentage of participants|||Number
2616758|NCT01987479|Secondary|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score|The FACIT-F score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.|||units on a scale||Standard Deviation|Mean
2616759|NCT01987479|Secondary|Percentage of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records|A diary card was provided to participants to record home injections. Participants were asked to return all empty drug supply boxes, unused pre-filled syringe, and diary cards to the clinic at each visit as a measure of drug accountability and participant compliance. A participant was considered compliant if the participant correctly administered all scheduled doses of SC tocilizumab during the assessment period.|Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24)|FAS population. “n” = participants who were evaluable at specified timepoint.|||percentage of participants|||Number
2616783|NCT01987453|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||Percentage of participants|||Number
2616760|NCT01987479|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.|||units on a scale||Standard Deviation|Mean
2616761|NCT01987479|Secondary|Patient Pain VAS Scores|This assessment represents the participant's assessment of his/her current level of pain on a 100 mm horizontal VAS where 0 mm= no pain to 100 mm= unbearable pain.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Early withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.|||mm||Standard Deviation|Mean
2616762|NCT01987479|Secondary|Patient Global Assessment of Disease Activity VAS Scores|Patient global assessment of disease activity was measured on a 0 to 100 mm horizontal VAS where 0 mm=no disease activity and 100 mm=maximum disease activity.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Early withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.|||mm||Standard Deviation|Mean
2616763|NCT01987479|Secondary|Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs)||Baseline, Weeks 12 and 24, Early Withdrawal (up to Week 24), Follow-up Visit (8 weeks after last dose of tocilizumab, up to 32 weeks)|FAS population. “n” = participants who were evaluable at specified timepoint.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2616764|NCT01987479|Secondary|Serum Levels of Tocilizumab||Baseline, Weeks 12 and 24, Early Withdrawal (up to Week 24), Follow-up Visit (8 weeks after last dose of tocilizumab, up to 32 weeks)|FAS population. “n” = participants who were evaluable at specified timepoint.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
2616765|NCT01987479|Secondary|Percentage of Participants With Anti-Tocilizumab Antibodies||Baseline, Weeks 12 and 24, early withdrawal (up to Week 24), follow-up visit (8 weeks after last dose of tocilizumab, up to 32 weeks)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.|||percentage of participants|||Number
2616766|NCT01987479|Secondary|Time to Discontinuation or First Dose Reduction of Corticosteroids or NSAIDs|Time to discontinuation or first dose reduction of corticosteroids or NSAIDs (weeks) = (Date of the first dose reduction or end date of corticosteroids or NSAIDs treatment - date of first drug intake of this study) + 1. Time to discontinuation or first dose reduction was based on the first occurring event (corticosteroid discontinuation or corticosteroid first dose reduction or NSAIDs discontinuation or NSAIDs first dose reduction, whichever occurred first).|Baseline up to Week 32|FAS population|||weeks||95% Confidence Interval|Median
2616767|NCT01987479|Secondary|Percentage of Participants With Corticosteroid Dose Reductions or Discontinuation Categorized by Reasons|Results are reported for percentage of participants who had corticosteroid dose reductions or discontinuation by reasons for dose reductions or discontinuation (unknown reasons, safety reasons, other reasons, lack of efficacy, and discomfort).|From Week 16 and before Week 20; From Week 20 and before Week 24|FAS population|||percentage of participants|||Number
2616768|NCT01987479|Secondary|Percentage of Participants With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Dose Reductions or Discontinuation Categorized by Reasons|Results are reported for percentage of participants who had NSAIDs dose reductions or discontinuation by reasons for dose reductions or discontinuation (unknown reasons, safety reasons, other reasons, lack of efficacy, and discomfort).|From Week 16 and before Week 20; From Week 20 and before Week 24|FAS population|||percentage of participants|||Number
2616769|NCT01987479|Secondary|Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal|Number of swollen joints was determined by examination of 28 joints for SJC28 and 66 joints for SJC66 and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28 for a SJC28 and 66 for a SJC66. A reduction in number of swollen joints compared to baseline indicates improvement.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.|||swollen joints||Standard Deviation|Mean
2616770|NCT01987479|Secondary|Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal|Number of tender joints was determined by examining 28 joints for TJC28 and 68 joints for TJC68, and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28 for a TJC28 and 68 for a TJC68. A reduction in number of tender joints compared to baseline indicates improvement.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.|||tender joints||Standard Deviation|Mean
2616771|NCT01987479|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 16, 20, 24, and Early Withdrawal|The CDAI is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician's global assessment of disease activity assessed on 0-10 cm VAS (0 cm= no disease activity and 10 cm= worst disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at specified timepoint.|||units on a scale||Standard Deviation|Mean
2616780|NCT01987453|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit confirmed with 2 consecutive values or last available posttreatment measurement"|Up to posttreatment Week 24|Full Analysis Set|||Percentage of participants|||Number
2616772|NCT01987479|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician global assessment of disease activity assessed on 0-10 centimeter (cm) VAS (0 cm= no disease activity and 10 cm= worst disease activity), and CRP in milligrams per liter (mg/L). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity .|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. Here, “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome. “n” = participants who were evaluable at specified timepoint.|||units on a scale||Standard Deviation|Mean
2616773|NCT01987479|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR|DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). DAS28-ESR scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. The DAS28-ESR based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1. Participants with change from baseline >0.6 to ≤1.2 with a DAS28 score >5.1, or any score with change from baseline ≤0.6, were assessed as non-responders.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. “n” = participants who were evaluable at specified timepoint.|||percentage of participants|||Number
2616774|NCT01987479|Secondary|Percentage of Participants Achieving an ACR90 Response|A participant had an ACR90 response if there was at least a 90% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0 mm=no pain to 100 mm=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR).|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. “n” = participants who were evaluable at specified timepoint.|||percentage of participants|||Number
2616775|NCT01987479|Secondary|Percentage of Participants Achieving an ACR70 Response|A participant had an ACR70 response if there was at least a 70% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0 mm=no pain to 100 mm=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR).|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. “n” = participants who were evaluable at specified timepoint.|||percentage of participants|||Number
2616776|NCT01987479|Secondary|Percentage of Participants Achieving an ACR50 Response|A participant had an ACR50 response if there was at least a 50% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0 mm=no pain to 100 mm=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR).|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. “n” = participants who were evaluable at specified timepoint.|||percentage of participants|||Number
2616777|NCT01987479|Secondary|Percentage of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response|A participant had an ACR20 response if there was at least a 20 percent (%) improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0 mm=no pain to 100 mm=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either C-reactive protein [CRP] or ESR).|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. “n” = participants who were evaluable at specified timepoint.|||percentage of participants|||Number
2616778|NCT01987479|Secondary|Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal|DAS28 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR; millimeters per hour [mm/hour]), and patient's global assessment of disease activity (measured on a 0 to 100 mm Visual Analog Scale [VAS] where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR less than or equal to (≤) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-ESR less than (<) 2.6 implied clinical remission.|Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)|FAS population. Here, “n” = participants who were evaluable at the specified timepoint.|||units on a scale||Standard Deviation|Mean
2616781|NCT01987453|Secondary|Change in HCV RNA From Baseline||Baseline to Week 8|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
2616785|NCT01987453|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.|Post-treatment Week 12|Full Analysis Set: participants enrolled into the study and received at least 1 dose of study drug|||Percentage of participants|||Number
2616786|NCT01987427|Secondary|Change From Baseline in Waist to Hip Circumference Ratio at Week 12||Baseline and Week 12 (end of treatment)|The MITT set included all randomized participants who received at least one dose of the study drug and had a Baseline weight measurement and a post-randomization weight measurement. Participants who were evaluable for this measure at given time period were included in the assessment.|||ratio||Standard Deviation|Mean
2616787|NCT01987427|Secondary|Change From Baseline in Waist Circumference and Hip Circumference at Week 12||Baseline and Week 12 (end of treatment)|The MITT population consisted of all randomized participants who received at least one dose of the study drug and had a Baseline weight measurement and a post-randomization weight measurement. Participants who were evaluable for this measure at given time period were included in the assessment.|||centimeter (cm)||Standard Deviation|Mean
2616788|NCT01987427|Secondary|Percentage of Participants Who Achieved Greater Than or Equal to (>=) 5 Percent (%) Weight Reduction at Week 12||Week 12 (end of treatment)|The MITT set included all randomized participants who received at least one dose of the study drug and had a Baseline weight measurement and a post-randomization weight measurement.|||percentage of participants|||Number
2616789|NCT01987427|Secondary|Percent Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12||Baseline, Weeks 1, 2, 4, 8 and 12|The MITT set included all randomized participants who received at least one dose of the study drug and had a Baseline weight measurement and a post-randomization weight measurement. Participants who were evaluable for this measure at given time period were included in the assessment.|||percent change||Standard Deviation|Mean
2616790|NCT01987427|Secondary|Mean Change From Baseline in Body Weight at Weeks 1, 2, 4, 8, and 12||Baseline, Weeks 1, 2, 4, 8 and 12|The Modified Intent-to-Treat (MITT) set included all randomized participants who received at least one dose of the study drug and had a Baseline weight measurement and a post-randomization weight measurement. Participants who were evaluable for this measure at given time period were included in the assessment.|||kilogram (kg)||Standard Deviation|Mean
2616791|NCT01987427|Secondary|Number of Participants With Treatment-Emergent Markedly Abnormal Laboratory Values||Baseline up to Week 16|The safety analysis set included all randomized participants who received at least one dose of study drug and had at least one post-baseline safety assessment. Participants who were evaluable for this measure for given laboratory parameter were included in the assessment.|||Participants|||Count of Participants
2616792|NCT01987427|Secondary|Number of Participants With Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE) and AEs Leading to Study Drug Discontinuation||Baseline up to Week 16|The safety analysis set included all randomized participants who received at least one dose of study drug and had at least one post-baseline safety assessment.|||Participants|||Count of Participants
2616793|NCT01987427|Primary|Percentage of Participants Reporting at Least One of Nine Adverse Events (AEs) of Main Interests That May Related to Serotonergic Reaction|The nine common serotonergic AEs were headache, dizziness, nausea, fatigue, dry mouth, diarrhea, vomiting, insomnia, and/or anxiety.|Baseline up to Week 12 (end of treatment)|The full analysis set included all randomized participants who received at least one dose of the study drug.|||percentage of participants|||Number
2616794|NCT01987414|Secondary|Upper Extremity Strength - Lateral Pinch|A pinch gauge will be used to measure pinch strength in pounds. Participants are asked to complete this task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||lbs||Standard Deviation|Mean
2616795|NCT01987414|Secondary|Upper Extremity Strength - Palmar Pinch|A pinch gauge will be used to measure pinch strength in pounds. Participants are asked to complete this task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||lbs||Standard Deviation|Mean
2616796|NCT01987414|Secondary|Upper Extremity Strength - Grip|A Jamar Dynamometer will be used to measure grip strength in pounds. Participants are asked to complete this task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||lbs||Standard Deviation|Mean
2616797|NCT01987414|Secondary|Upper Extremity Strength - Wrist Extension|A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||lbs||Standard Deviation|Mean
2616798|NCT01987414|Secondary|Upper Extremity Strength - Forearm Supination|A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||lbs||Standard Deviation|Mean
2616799|NCT01987414|Secondary|Upper Extremity Strength - Forearm Pronation|A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||lbs||Standard Deviation|Mean
2616800|NCT01987414|Secondary|Upper Extremity Strength - Elbow Extension|A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||lbs||Standard Deviation|Mean
2616801|NCT01987414|Secondary|Upper Extremity Strength - Shoulder Abduction|A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||lbs||Standard Deviation|Mean
2616802|NCT01987414|Secondary|Upper Extremity Strength - Shoulder Flexion|A hand-held dynamometer will be used to measure upper extremity strength in pounds. Participants are asked to complete each task 3 times. Reported data is the mean of 3 attempts. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||lbs||Standard Deviation|Mean
2616803|NCT01987414|Secondary|Goniometric Measurements - Wrist Extension|A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||degrees||Standard Deviation|Mean
2616804|NCT01987414|Secondary|Goniometric Measurements - Forearm Supination|A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||degrees||Standard Deviation|Mean
2616805|NCT01987414|Secondary|Goniometric Measurements - Forearm Pronation|A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||degrees||Standard Deviation|Mean
2616806|NCT01987414|Secondary|Goniometric Measurements - Elbow Extension|A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||degrees||Standard Deviation|Mean
2616807|NCT01987414|Secondary|Goniometric Measurements - Shoulder Abduction|A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||degrees||Standard Deviation|Mean
2616808|NCT01987414|Secondary|Goniometric Measurements - Shoulder Flexion|A goniometer will be used to measure active and passive range of motion of the upper extremity in degrees. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||degrees||Standard Deviation|Mean
2616809|NCT01987414|Primary|Motor Activity Log (MAL) - How Well|This test is used to measuring participants' actual use of the involved arm in the real world. This interview-style test contains 30 items. Participants are asked how well they use their non-dominant arm/hand to complete each of the 30 tasks. Scores range from 0 (never use non-dominant hand) to 5 (normal use of non-dominant hand). The total score is a mean of 30 item scores. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||units on a scale||Standard Deviation|Mean
2616810|NCT01987414|Primary|Motor Activity Log (MAL) - Amount of Use|This test is used to measuring participants' actual use of the involved arm in the real world. This interview-style test contains 30 items. Participants are asked how often they use their non-dominant arm/hand to complete each of the 30 tasks. Scores range from 0 (never use non-dominant hand) to 5 (normally use non-dominant hand). The total score is a mean of 30 item scores. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||score on a scale||Standard Deviation|Mean
2616811|NCT01987414|Primary|Wolf Motor Function Test (WMFT) - Function|This test will be used to quantitatively assess participants' motor function of the upper extremity. Participants will be asked to complete 15 tasks, each within a 120-second window. Participants are scored on their ease of completing each task. Scores range from 1 to 3, with higher scores representing greater ease of task completion. The total score is mean value of the 15 item scores. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||score on a scale||Standard Deviation|Mean
2616812|NCT01987414|Primary|Wolf Motor Function Test (WMFT) - Time|This test will be used to quantitatively assess participants' motor function of the upper extremity. Participants will be asked to complete 15 tasks, each within a 120-second window. The number of seconds required to complete the task is recorded. If the participant exceeds 120 seconds, no additional time will be added and 120 seconds will be recorded. The total score is calculated as a mean of score (in seconds) from the 15 tasks. Collected data will be used to measure changes within and between groups between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||seconds||Standard Deviation|Mean
2616813|NCT01987414|Primary|Canadian Occupational Performance Measure (COPM) - Satisfaction|Used to evaluate participants' self-perceived satisfaction with performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their satisfaction of how well they are able to complete each task on a scale of 1 (unsatisfied) to 10 (completely satisfied). Total scores are an mean of individual task scores and also range from 1 (unsatisfied) to 5 (completely satisfied). Collected data will be used to measure changes within and between groups on self-perceived satisfaction with performance between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||score on a scale||Standard Deviation|Mean
2616814|NCT01987414|Primary|Canadian Occupational Performance Measure (COPM) - Performance|Used to evaluate participants' self-perceived functional performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their perception of how well they are able to complete each task on a scale of 1 (unable to perform) to 10 (able to perform extremely well). Total scores are an mean of individual task scores and also range from 1 (unable to perform tasks) to 5 (able to perform tasks extremely well). Collected data will be used to measure changes within and between groups on self-perceived performance between week 1 and 8, week 1 and 15, as well as week 8 and 15.|Week 1, 8, and 15||||score on a scale||Standard Deviation|Mean
2616815|NCT01987401|Primary|Participation Rates|From the national sample, the investigators will compare participation rates for the mailed survey and telephone survey. Among a sample of Veterans living in the greater Boston area, the investigators will calculate participation rate for the in-person survey.|18 months||||Participants|||Count of Participants
2616816|NCT01987349|Other Pre-specified|Lymphocyte Response to Influenza Immunization|Compare lymphocyte responses at Days 6-14 and the lymphocyte and serology responses at Day 28 post-immunization following annual administration of the influenza vaccines|Day 6-28 post-immunization|||||||
2616819|NCT01987232|Other Pre-specified|Duration of Response|"Duration of response (DOR) was calculated for participants who achieved a confirmed CR or PR. defined as the time from first evidence of confirmed PR/CR to disease progression or death due to any cause. Median DOR was calculated using Kaplan-Meier methods. Participants with no baseline disease assessments, who started a new anticancer therapy before documentation of PD or death, with death or PD immediately after more than 1 consecutively missed disease assessment visit or alive without documentation of PD before the data cutoff date were censored.~DOR was originally specified as a secondary endpoint for the phase 2 portion of the study. Since phase 2 did not proceed, DOR was analyzed in phase 1b participants on an exploratory basis."|From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks.|Participants with a confirmed response of PR or CR.|||months||95% Confidence Interval|Median
2616820|NCT01987232|Other Pre-specified|Overall Response Rate|"The overall response rate (ORR) was defined as the percentage of participants for whom the best overall confirmed response was either complete response (CR) or partial response (PR) assessed by the investigator according to RECIST v1.1 criteria.~CR: Disappearance of all target and non-target lesions, no new lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.~PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker levels above normal limits."|From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks.|All participants who received at least 1 dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2616821|NCT01987232|Other Pre-specified|Progression-free Survival|"Progression-free survival (PFS) was specified as a primary endpoint for the phase 2 portion of the study. Since phase 2 did not proceed PFS was analyzed in phase 1b participants on an exploratory basis. PFS was defined as the time from the start of treatment to documented disease progression or death due to any cause, whichever occurred first. Disease progression was determined by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, defined as at least a 20% increase in the size of target lesions (absolute increase ≥ 5 mm), unequivocal progression of existing non-target lesions, or any new lesions.~Median PFS was calculated using Kaplan-Meier methods. Participants with no baseline disease assessments, who started a new anticancer therapy before documentation of PD or death, with death or PD immediately after more than 1 consecutively missed disease assessment visit or alive without documentation of PD before the data cutoff date were censored."|From first dose of study drug until the end of treatment; median duration of treatment was 16 weeks.|All participants who received at least 1 dose of study treatment.|||months||95% Confidence Interval|Median
2616822|NCT01987232|Secondary|Area Under Plasma Concentration-Time Curve - Phase 2|Pharmacokinetic (PK) analyses were specified as secondary endpoints for the phase 2 portion of the study; since phase 2 was not conducted, PK analyses were not performed.|Cycle 1 Day 2|Phase 2 participants||||||
2616823|NCT01987232|Secondary|Time of Maximum Plasma Concentration - Phase 2|Pharmacokinetic (PK) analyses were specified as secondary endpoints for the phase 2 portion of the study; since phase 2 was not conducted, PK analyses were not performed.|Cycle 1 Day 2|Phase 2 participants||||||
2616824|NCT01987232|Secondary|Maximum Plasma Concentration - Phase 2|Pharmacokinetic (PK) analyses were specified as secondary endpoints for the phase 2 portion of the study; since phase 2 was not conducted, PK analyses were not performed.|Cycle 1 Day 2|Phase 2 participants||||||
2616825|NCT01987232|Secondary|Overall Survival (OS) - Phase 2|Overall Survival (OS) is defined as the time from randomization to the date of death. Overall survival was a specified secondary endpoint for the phase 2 portion of the study; since phase 2was not conducted, OS was not analyzed.|30 months|Participants enrolled in phase 2||||||
2616826|NCT01987232|Secondary|Number of Participants With Adverse Events (AEs)|"The severity of each adverse event was assessed using the NCI-CTCAE Version 4.03 according to the following:~Grade 1 - Mild: Asymptomatic or mild symptoms; intervention not indicated~Grade 2 - Moderate: Minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL)~Grade 3 - Severe: Medically significant but not life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL~Grade 4 - Life-threatening~Grade 5 - Fatal.~A serious AE is an AE that met one or more of the following criteria:~Death~Life-threatening~Required inpatient hospitalization or prolongation of an existing hospitalization~Resulted in persistent or significant disability/incapacity~A congenital anomaly/birth defect~Important medical events that required medical or surgical intervention to prevent one of the outcomes above."|From first day of any study treatment (i.e., carfilzomib, carboplatin, or etoposide) up to 30 days after the last day of study treatment. The median overall duration of treatment was 16 weeks.|All participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2616827|NCT01987232|Primary|Number of Participants With Dose-limiting Toxicities|"The maximum tolerated dose (MTD) was defined as the highest dose level at which < 33% of participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle. Dose-limiting toxicities were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. A DLT was defined as:~A grade 3 or greater non-hematologic toxicity that was assessed as related to carfilzomib by the investigator except in the case of neuropathy. A grade 2 or higher neuropathy with pain was considered a DLT.~Grade 4 neutropenia: absolute neutrophil count (ANC) < 500 mm³, lasting ≥ 7 days despite granulocyte colony stimulating factor support, or any febrile (temperature > 38.3°C) neutropenia (ANC < 1000 mm³).~Thrombocytopenia of any grade associated with clinically significant bleeding or platelet/blood transfusion~Grade 4 fatigue lasting ≥ 7 days~Grade 3 nausea, vomiting or diarrhea lasting ≥ 7 days."|First 21-day Cycle|All participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2616828|NCT01987219|Secondary|Change in Forced Expiratory Flow Between 25-75% (FEF25-75)|FEF25-75 is measured in liters of air per second at 25-75%|pre and 30 minutes post intervention||||percentage change from baseline||Standard Deviation|Mean
2616829|NCT01987219|Secondary|Change in Forced Expiratory Volume (FEV) From Baseline|Forced expiratory volume is measured in liters of air per second. FEV was measured during the first second of exhalation.|Pre and 30 post study drug admistration||||percentage change from baseline||Standard Deviation|Mean
2616830|NCT01987219|Primary|Change in Respiratory Function (Airway Resistance at 5 Hz) From Baseline|The percentage change in respiratory function from baseline is measured in percentage change in Resistance, kPa/(L/s).|Pre and 30 minutes post study drug administration||||percentage change from baseline||Standard Deviation|Mean
2616831|NCT01987219|Primary|Change From Baseline of Forced Vital Capacity|FVC is a measure of the amount of air exhaled, and is measured in liters of air per second. The percentage in the change in the amount of air exhaled from baseline, measured in liters of air per second. Increase in the percentage of air exhaled from baseline indicates improvement in respiratory function.|Pre and 30 minutes post study drug administration|Per protocol|||percentage change from baseline||Standard Deviation|Mean
2616832|NCT01987102|Secondary|Characterization (Number/Severity) of All Reported AEs During the ENTIRE STUDY PERIOD.|The severity of AEs have been done using NCI CTCAE v4.0. Total number of AEs per severity grade are presented for all AEs and for AEs related to MTX. For AEs related to MTX the number of AEs occurring per preferred term and severity grade are detailed.The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE; Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening, and Grade 5 Death related to AE.|From the start of HDMTX administration through 8 days post dose for all 4 courses of HDMTX in total|The All Patients Treated Set (APTS) included all patients receiving at least one bolus injection of Modufolin (MOD).|||Number of AEs|||Number
2616833|NCT01987102|Secondary|Number of Grade A1, Grade A2, Grade B, Grade C, or Grade D Excretion Toxicities as Listed in the MTX-toxicity Management Instructions|The MTX-toxicity management instructions provided in the protocol are based on the Children's Oncology Group (COG) treatment management recommendations used in study protocol AOST0331, EURAMOS 1. The COG recommend changes in the hydration and the rescue frequency and/or dose to be done if pre-specified toxicities of different severity grades occur.|Time from start of MTX treatment until serum MTX level is ≤ 0.1 μmol/L|The All Patients Treated Set (APTS) included all patients receiving at least one bolus injection of Modufolin (MOD).|||Number of MTX excretion toxicities|||Number
2616834|NCT01987102|Secondary|Number of HDMTX Courses With Delayed Late MTX Elimination (Definition F).|"Definition F: Delayed late MTX elimination (according to US label for Calcium Folinate)~S-MTX level:~> 0.2 μmol/L at 72 hours AND > 0.1 μmol/L at 96 hours after start of MTX administration."|Time from start of MTX treatment until serum MTX level is ≤ 0.1 μmol/L|The All Patients Treated Set (APTS) included all patients receiving at least one bolus injection of Modufolin (MOD).|||Number of courses|||Number
2616835|NCT01987102|Secondary|Number of HDMTX Courses With Delayed Early MTX Elimination (Definition E).|"Definition E: Delayed early MTX elimination (according to US label for Calcium Folinate)~S-MTX levels of:~50 μmol/L at 24 hours after start of MTX administration, OR~5 μmol/L at 48 hours after start of MTX administration OR An increase in S-Creatinine level of 100% or greater at 24 hours after start of MTX administration."|Time from start of MTX treatment until serum MTX level is ≤ 0.1 μmol/L|The All Patients Treated Set (APTS) included all patients receiving at least one bolus injection of Modufolin (MOD).|||Number of courses|||Number
2616836|NCT01987102|Secondary|Number of HDMTX Courses With Delayed MTX Elimination (Definition D).|"Definition D: Delayed MTX elimination (according to COGs excretion toxicity management instructions)~S-MTX levels of:~> 10 μmol/L at 24 h after start of MTX administration, OR > 1 μmol/L at 48 h after start of MTX administration, OR > 0.1 μmol/L at 72 h after start of MTX administration or later"|Time from start of MTX treatment until serum MTX level is ≤ 0.1 μmol/L|The All Patients Treated Set (APTS) included all patients receiving at least one bolus injection of Modufolin (MOD).|||Number of courses|||Number
2616837|NCT01987102|Secondary|Number of HDMTX Courses in Which the Initial Hydration Was Increased||Time from start of MTX treatment until serum MTX level is ≤ 0.1 μmol/L|The All Patients Treated Set (APTS) included all patients receiving at least one bolus injection of Modufolin (MOD).|||HDMTX courses|||Number
2616838|NCT01987102|Secondary|Time to Successful MTX Elimination (Definition C)|Definition C: Time to successful MTX elimination = Time from start of MTX treatment until serum MTX level is ≤ 0.1 μmol/L|Time from start of MTX treatment until serum MTX level is ≤ 0.1 μmol/L|The All Patients Treated Set (APTS) included all patients receiving at least one bolus injection of Modufolin (MOD).|||hours||Standard Deviation|Mean
2616839|NCT01987102|Secondary|Number of Administered MAP Cycles Classified as Having Met the Criteria for Successful Advancement to Next MAP Cycle According to Definition B.|"Definition B: Successful advancement to next MAP cycle~Fulfilling all of the following criteria 8 days after start of the second HDMTX course in previous MAP cycle:~Serum MTX: ≤ 0.1 μmol/L~Neutrophils: ≥ 0.75 x 109/L~Platelets: ≥ 75 x 109/L~Serum bilirubin: ≤ 1.25 x ULN~GFR ≥ 70 mL/min/1.73 m2~No AE Grade 2 or more (NCI CTCAE v4.0) related to HDMTX hindering a potential Adriamycin/Doxorubicin and Cisplatin (AP) administration, at the discretion of the investigator"|8 days after start of second HDMTX course in a MAP cycle|The All Patients Treated Set (APTS) included all patients receiving at least one bolus injection of Modufolin (MOD).|||Number of courses|||Number
2616840|NCT01987102|Secondary|Number of Administered MAP Cycles Classified as Having Met the Criteria for Successful Advancement From First to Second HDMTX Course Within the Same MAP Cycle According to Definition A.|"Definition A: Successful advancement from first to second HDMTX course within the same MAP cycle~Fulfilling all of the following criteria 8 days after start of first HDMTX course within the same MAP cycle:~Serum MTX: ≤ 0.1 μmol/L~Neutrophils: ≥ 0.25 x 109/L~Platelets: ≥ 50 x 109/L~Serum bilirubin: ≤ 1.25 x ULN~GFR ≥ 70 mL/min/1.73 m2~No AE Grade 2 or more (NCI CTCAE v4.0) related to HDMTX hindering a potential HDMTX administration, at the discretion of the investigator"|8 days after start of first HDMTX course in a MAP cycle|The All Patients Treated Set (APTS) included all patients receiving at least one bolus injection of Modufolin (MOD).|||Number of courses|||Number
2616858|NCT01986946|Secondary|Patient Satisfaction With Perioperative Analgesia|Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit. Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).|Post-operative Day 1|Analyasis was completed on all participants who completed the patient satisfaction with perioperative analgesia assessment.|||units on a scale||Standard Deviation|Mean
2616859|NCT01986946|Primary|Post-operative Pain as Assessed by Visual Analogue Scale (VAS)|The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.|Postoperative day 1|Participant that provided a VAS score at postoperative day 1 time point.|||units on a scale||Standard Deviation|Mean
2616841|NCT01987102|Secondary|Number of Administered HDMTX Courses Classified as Having Met the Criteria for Successful Advancement According to Definition A and/or Definition B|"Definition A: Successful advancement from 1st to 2nd HDMTX course within the same MAP cycle. Fulfilling all of the following criteria 8 days after start of first HDMTX course within the same MAP cycle:~Serum MTX: ≤0.1μmol/L~Neutrophils: ≥0.25x109/L~Platelets: ≥50x109/L~Serum bilirubin: ≤1.25 x upper limit of normal (ULN)~Glomerular filtration rate (GFR) ≥70 mL/min/1.73m2~No AE Grade 2 or more related to HDMTX hindering a potential HDMTX administration, at the discretion of the investigator~Definition B: Successful advancement to next MAP cycle~Fulfilling all of the following criteria 8 days after start of the second HDMTX course in previous MAP cycle:~Serum MTX: ≤0.1μmol/L~Neutrophils: ≥ 0.75 x 109/L~Platelets: ≥75x109/L~Serum bilirubin: ≤1.25xULN~GFR ≥70 mL/min/1.73m2~No AE Grade 2 or more related to HDMTX hindering a potential Adriamycin/Doxorubicin and Cisplatin (AP) administration, at the discretion of the investigator"|8 days after start of first and/or second HDMTX course in a MAP cycle|The All Patients Treated Set (APTS) included all patients receiving at least one bolus injection of Modufolin (MOD).|||Number of courses|||Number
2616842|NCT01987102|Primary|Number of Ongoing HDMTX Related AEs Per HDMTX Course|Characterization (frequency and severity grade) of toxicity reported for each course of HDMTX treatment with folate rescue therapy and continuing until eight (8) days after start of HDMTX administration, per NCI CTCAE v4.0 (Grade refers to the severity of the AE). The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE; Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening, and Grade 5 Death related to AE.|From the start of HDMTX administration through 8 days post dose for each course of HDMTX|The All Patients Treated Set (APTS) included all patients receiving at least one bolus injection of Modufolin (MOD).|||Number of AEs|||Number
2616843|NCT01987102|Primary|Number of Ongoing AEs Per HDMTX Course|Characterization (frequency and severity grade) of toxicity reported for each course of HDMTX treatment with folate rescue therapy and continuing until eight (8) days after start of HDMTX administration, per NCI CTCAE v4.0 (Grade refers to the severity of the AE). The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE; Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening, and Grade 5 Death related to AE.|From the start of HDMTX administration through 8 days post dose for each course of HDMTX|The All Patients Treated Set (APTS) included all patients receiving at least one bolus injection of Modufolin (MOD).|||Number of AEs|||Number
2616844|NCT01987102|Primary|Number of HDMTX Related AEs Per Severity (All Courses)|Characterization (frequency and severity grade) of toxicity reported for each course of HDMTX treatment with folate rescue therapy and continuing until eight (8) days after start of HDMTX administration, per NCI CTCAE v4.0 (Grade refers to the severity of the AE). The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE; Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening, and Grade 5 Death related to AE.|From the start of HDMTX administration through 8 days post dose for each course of HDMTX in total|The All Patients Treated Set (APTS) included all patients receiving at least one bolus injection of Modufolin (MOD).|||Number of AEs|||Number
2616845|NCT01987102|Primary|Number of AEs Per Severity (All Courses)|Characterization (number and severity grade) of toxicity reported for each course of HDMTX treatment with folate rescue therapy and continuing until eight (8) days after start of HDMTX administration, per NCI CTCAE v4.0 (Grade refers to the severity of the AE). The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE; Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening, and Grade 5 Death related to AE.|From the start of HDMTX administration through 8 days post dose for each course of HDMTX in total|The All Patients Treated Set (APTS) included all patients receiving at least one bolus injection of Modufolin (MOD).|||Number of AEs|||Number
2616846|NCT01986985|Primary|PET/MR Images Clinical Usefulness|Clinically relevant images are obtained|1 day|Subjects with images successfully collected using PET/ MR|||Participants|||Number
2616847|NCT01986946|Secondary|Wound Infection Rates||during hospitalization (approximately 3-8 days)|Data not collected||||||
2616848|NCT01986946|Secondary|Length of Hospital Stay||during hospitalization (approximately 3-8 days)||||days||Standard Deviation|Mean
2616849|NCT01986946|Secondary|Number of Participants Readmitted to Hospital Within 30 Days of Surgery||Post-operative Day 30||||participants|||Number
2616850|NCT01986946|Secondary|Number of Participants Experiencing Delirium||Post-operative Day 3|Participants who were evaluated for Delirium on Day 3|||participants|||Number
2616851|NCT01986946|Secondary|Number of Participants Experiencing Delirium||Post-operative Day 2|Participants who were evaluated for Delirium on Day 2|||participants|||Number
2616852|NCT01986946|Secondary|Number of Participants Experiencing Delirium||Post-operative Day 1|Only participants who had assessment for delirium are include in the analysis.|||participants|||Number
2616853|NCT01986946|Secondary|Total Post-operative Opioid Consumption||during hospitalization (approximately 3-8 days)||||oral morphine equivilant (mg)||Standard Deviation|Mean
2616854|NCT01986946|Secondary|Number of Participants With Adverse Events Related to the Study|Patients will be assessed in the recovery room and each day of their epidural or intravenous opioid infusions, and at their surgical follow-up visit.|6-week Follow up Visit||||participants|||Number
2616855|NCT01986946|Secondary|Number of Participants With Events of Special Interest|Patients will be assessed for development of a deep vein thrombosis after surgery, and surgical site infection.|Post-operative Day 30|Data not collected||||||
2616856|NCT01986946|Secondary|Patient Satisfaction With Overall Care|Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).|6-Week Follow up Visit|Participants who completed the patient satisfaction scale at the 6 week follow up visit.|||units on a scale||Standard Deviation|Mean
2616857|NCT01986946|Secondary|Patient Satisfaction With Perioperative Analgesia|Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit. Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).|6-Week Follow up Visit|Participants who completed the patient satisfaction scale at the 6 week follow up visit.|||units on a scale||Standard Deviation|Mean
2617055|NCT01984424|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 22 and 24||Baseline and weeks 22 and 24|Participants randomized and dosed in part B of the study|||percent change||Standard Error|Least Squares Mean
2616860|NCT01986920|Secondary|Subject's Self Assessment Scale|Subjects self assessment of the condition of their lesions based on a scale of Clear (Grade 0), Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3).|Visit 9 (Day 78)|A total of 35 subjects were enrolled with 34 subjects in the analysis population. Each target lesion on a subject was treated with one of the 4 study medications in a random fashion.|||Participants|||Count of Participants
2616861|NCT01986920|Primary|Mean Change in Physician Lesion Assessment Scale|"Mean Change in Score on the Physician Lesion Assessment Scale (PLA) of each Target Lesion. The PLAS is a four point scale from 0-3 with 0 being clear and 3 being the worst lesion.~The primary effectiveness will consist of the mean change from Visit 2 to Visit 9 in PLA performed using Analysis of Covariance (ANCOVA) with Visit 2 PLAS as the covariate. Comparisons between vehicle and each active treatment group will be performed within the model using least-squares means and the common error term."|Visit 2 to visit 9 (78 days)|A total of 35 subjects were enrolled with 34 subjects in the analysis population. Each target lesion on a subject was treated with one of the 4 study medications in a random fashion.|||Change in Score on a scale||Standard Deviation|Mean
2616862|NCT01986907|Primary|Number of Eyes With Ocular Drug-related Adverse Events|Monitoring and recording all adverse events, including serious adverse events.|Baseline to Month 12|Safety Set|||eyes|eyes||Number
2616863|NCT01986907|Secondary|Mean Number of Injections Per Patient|Number of injections per patient|Baseline to month 12|Safety set|||injections||Standard Deviation|Mean
2616864|NCT01986907|Secondary|Time Interval Between Injections in Bilateral Disease|Mean number of days between two consecutive injections per eye|Baseline to month 12|This analysis population includes all eyes naïve to ranibizumab, i.e., had not been treated with the study medication (or with the equivalent commercial formulation) before the first study drug injection, regardless of whether the contralateral eye had been treated.|||days|eyes|Standard Deviation|Mean
2616865|NCT01986907|Secondary|Overall Number of Ranibizumab Injections||Baseline to month 12|Safety Set|||injections per patient||Standard Deviation|Mean
2616866|NCT01986907|Primary|Number of Participants With Systemic Drug-related Adverse Events|Monitoring and recording all adverse events, including serious adverse events.|Baseline to Month 12|Safety Set|||participants|||Number
2616867|NCT01986855|Secondary|Percentage of Participants With A1C <7.0% (<53 mmol/Mol) at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Week 26|The analysis population included all randomized participants with a Baseline eGFR ≥45 to <60 mL/min/1.73m^2 and who took at least 1 dose of study treatment and had at least 1 assessment at Week 26 for the percentage of participants with an A1C <7% at Week 26 endpoint.|||Percentage of participants|||Number
2616868|NCT01986855|Secondary|Change From Baseline in FPG at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach|This change from baseline reflects the Week 26 FPG minus the Week 0 FPG. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants with a Baseline eGFR ≥45 to <60 mL/min/1.73m^2 and who took at least 1 dose of study treatment and had at least 1 assessment at or after baseline for the change from baseline at Week 26 FPG endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
2616869|NCT01986855|Secondary|Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach|This change from baseline reflects the Week 26 sitting systolic blood pressure minus the Week 0 sitting systolic blood pressure. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants with a Baseline eGFR of ≥45 to <60 mL/min/1.73m^2 and who took at least 1 dose of study treatment and had at least 1 assessment at or after baseline for the change from baseline at Week 26 sitting systolic blood pressure endpoint.|||mmHg||95% Confidence Interval|Least Squares Mean
2616870|NCT01986855|Secondary|Change From Baseline in Body Weight at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach|This change from baseline reflects the Week 26 body weight minus the Week 0 body weight. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants with a Baseline eGFR of ≥45 to <60 mL/min/1.73m^2 and who took at least 1 dose of study treatment and had at least 1 assessment at or after baseline for the change from baseline at Week 26 body weight endpoint.|||Kilograms||95% Confidence Interval|Least Squares Mean
2616871|NCT01986855|Secondary|Change From Baseline in A1C at Week 26 - Baseline eGFR ≥45 to <60 mL/Min/1.73m^2 Stratum - Excluding Rescue Approach|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants with a Baseline eGFR of ≥45 to <60 mL/min/1.73m^2 and who took at least 1 dose of study treatment and had at least 1 assessment at or after baseline for the change from baseline at Week 26 A1C endpoint.|||Percentage||95% Confidence Interval|Least Squares Mean
2616872|NCT01986855|Primary|Percentage of Participants Who Discontinued Study Treatment Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 52 weeks|The analysis population included all randomized participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
2616892|NCT01986751|Secondary|Compare the Opioid Consumption During the First 24 Hours Between the Study Group and the Control Group|Mg equivalent of morphine consumption during the first 24 hours between the study group and the control group|baseline to 24 hours post block|Study was prematurely terminated. No data were collected for this assessment||||||
2616873|NCT01986855|Primary|Percentage of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 54 weeks|The analysis population included all randomized participants who received at least 1 dose of study treatment.|||Percentage of participants|||Number
2616874|NCT01986855|Primary|Change From Baseline in A1C at Week 26 - Excluding Rescue Approach|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding rescue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.|Baseline and Week 26|The analysis population included all randomized participants who took at least 1 dose of study treatment and had at least 1 assessment at or after baseline for the change from baseline at Week 26 A1C endpoint.|||Percentage||95% Confidence Interval|Least Squares Mean
2616875|NCT01986829|Secondary|Change in Pain Following Ablation Procedure|Measured using the Brief Pain Inventory. Final assessment at time of disease progression. Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean BPI scores between any two times. All analyses will be two-sided at a significance level of 0.05.|Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)|The data for this outcome measure was not collected as participant's pain was collected via the Fact G7 questionnaire.||||||
2616876|NCT01986829|Secondary|Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Pain|"Measured with the FACT-G7 validated survey. Final assessment at time of disease progression.~The question participant was asked was I have pain~7 questions about quality of life with answers that range from 0=not at all to 4 = very much~Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small."|Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)|-2 participants were not evaluable for the outcome measure as they did not complete the surveys. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.|||Participants|||Count of Participants
2616877|NCT01986829|Secondary|Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Contentment of the Participant's Qualify of Life|"Measured with the FACT-G7 validated survey. Final assessment at time of disease progression.~The question participant was asked was I am content with the quality of my life right now~7 questions about quality of life with answers that range from 0=not at all to 4 = very much~Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small."|Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)|-2 participants were not evaluable for the outcome measure as they did not complete the surveys. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.|||Participants|||Count of Participants
2616878|NCT01986829|Secondary|Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Sleep Well|"Measured with the FACT-G7 validated survey. Final assessment at time of disease progression.~The question participant was asked was I am sleeping well~7 questions about quality of life with answers that range from 0=not at all to 4 = very much~Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small."|Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)|-2 participants were not evaluable for the outcome measure as they did not complete the surveys. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.|||Participants|||Count of Participants
2616879|NCT01986829|Secondary|Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Ability of the Participant to Enjoy Life|"Measured with the FACT-G7 validated survey. Final assessment at time of disease progression.~The question participant was asked was I am able to enjoy life~7 questions about quality of life with answers that range from 0=not at all to 4 = very much~Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small."|Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)|-2 participants were not evaluable for the outcome measure as they did not complete the surveys. 1 participant did not complete this question on the survey at pre-treatment. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.|||Participants|||Count of Participants
2616893|NCT01986751|Secondary|Compare the Mean VAS Scores at 24 Hours Post Procecure to Determine the Effectiveness of Perineural Clonidine on Duration of Postoperative Analgesia Between the Control Group and Study Group|The VAS score is measured as 0 - 10 with 0 being no pain to 10 being the worst pain imaginable to assess the efficacy of clonidine to control postoperative pain and patient satisfaction at the time of discharge.|baseline to 24 hours post block|Study was prematurely terminated. No data were collected for this assessment||||||
2617056|NCT01984398|Primary|Androxal Cmax Formulation B|To determine and compare the PK parameter Cmax between two formulations of Androxal|24 hours|Safety and PK populations are the same|||ng/mL||Standard Deviation|Mean
2616880|NCT01986829|Secondary|Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Worry That the Condition Will Get Worse|"Measured with the FACT-G7 validated survey. Final assessment at time of disease progression.~The question participant was asked was I worry that my condition will get worse~7 questions about quality of life with answers that range from 0=not at all to 4 = very much~Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small."|Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)|-2 participants were not evaluable for the outcome measures as they did not complete the surveys. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.|||Participants|||Count of Participants
2616881|NCT01986829|Secondary|Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Nausea|"Measured with the FACT-G7 validated survey. Final assessment at time of disease progression.~The question participant was asked was I have nausea~7 questions about quality of life with answers that range from 0=not at all to 4 = very much~Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small."|Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)|-2 participants were not evaluable for the outcome measures as they did not complete the surveys. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.|||Participants|||Count of Participants
2616882|NCT01986829|Secondary|Change in Quality of Life (QOL) Following Ablation Procedure as Measured by the Participant's Lack of Energy|"Measured with the FACT-G7 validated survey. Final assessment at time of disease progression.~The question participant was asked was I have a lack of energy~7 questions about quality of life with answers that range from 0=not at all to 4 = very much~Generalized estimating equation (GEE) analysis will be used to take into account the correlation of repeated measures from the same subject. Contrast statements will be used to compare mean QOL scores between any two times. All analyses will be two-sided at a significance level of 0.05. This statistical analysis was not able to be performed due to the sample size being too small."|Pre-treatment (baseline), post-treatment (1-month post ablation), and disease progression (up to 5 years post-ablation)|-2 participants were not evaluable for the outcome measures as they did not complete the surveys. An additional participant did not complete the survey at progression. 2 additional participants did not progress and did not complete the surveys at disease progression.|||Participants|||Count of Participants
2616883|NCT01986829|Secondary|Overall Survival (OS)|-Defined as time from diagnosis of metastatic disease to the time of death|Assessed up to 5 years||||months||Full Range|Median
2616884|NCT01986829|Primary|Progression-free Rate|Defined as the percentage of patients with no progression (local recurrence of an ablated lesion or the appearance of a new lesion) after ablation.|3 months||||Participants|||Count of Participants
2616885|NCT01986790|Primary|Satisfaction|A survey will be administered in order to measure the extent to which participants are satisfied with the information presented to them. Satisfaction was scored on a scale from 1 to 4, with higher scores indicating higher levels of satisfaction. Bivariate outcome data can be found below.|1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)|Analysis is represented as mean (standard deviation) of calculated satisfaction.|||Units on a scale||Standard Deviation|Mean
2616886|NCT01986790|Primary|Uncertainty|A survey will be administered in order to measure participants' confidence in the features of health insurance plans that matter most to them and the insurance plan they chose of the ones presented. Confidence in choice is scored on a scale from 0 to 100, with higher scores indicating more decisional conflict/more uncertainty/less confidence in choice. Bivariate outcome data can be found below.|1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)|Analysis is represented as mean (standard deviation) of calculated uncertainty.|||Units on a scale||Standard Deviation|Mean
2616887|NCT01986790|Primary|Knowledge|Knowledge measures the degree at which participants understand the details about health insurance plans. Knowledge was scored on a scale from 0 to 7 based on number of correct answers to the 7 items. A higher value is considered to be a better outcome. Bivariate outcome data can be found below.|1 day (Immediately following showing the participant the assigned intervention (plain language table, plain language table + visuals, or plain language table + narratives)|Analysis is represented as mean (standard deviation) of calculated knowledge.|||Units on a scale||Standard Deviation|Mean
2616888|NCT01986751|Secondary|Compare the Mean VAS Scores at 24 Hours Post Procedure to Determine the Patient Satisfaction on Duration of Postoperative Analgesia Between Control Group and Study Group|Compare the mean VAS scores at 24 hours between the study group and the control group to assess the efficacy of clonidine to control postoperative pain and patient satisfaction at the time of discharge.|baseline to 24 hours|Study was prematurely terminated. No data were collected for this assessment||||||
2616889|NCT01986751|Secondary|Mean Time to First Analgesic Intake Postoperative Between the Control Group and the Study Group.|Comparing the mean time to the first analgesic intake postoperative between the control group and the study group|baseline to 24 hours post block|Study was prematurely terminated. No data were collected for this assessment||||||
2616890|NCT01986751|Secondary|the Mean Time to Discharge After Start of Procedure for Each Group - Control and Study Group.|Comparing the mean hours from start of procedure to discharge between the study group and the control group|baseline to discharge (approximately 72 hours)|Study was prematurely terminated. No data were collected for this assessment||||||
2616891|NCT01986751|Secondary|Compare the Subjects Mean Arterial Blood Pressure Effect of Perineural Clonidine Versus Placebo|Comparing the mean arterial blood pressure between the study group and the control group to assess the effect of clonidine on blood pressure.|baseline to discharge from hospital (expected 3 days)|Study was prematurely terminated. No data were collected for this assessment||||||
2616894|NCT01986751|Primary|Compare the Mean Duration of Sensory and/or Motor Block Between the Study Group and the Control Group|Mean duration of sensory and/or motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.|baseline to 72 hours|Study was prematurely terminated. No data were collected for this assessment||||||
2616895|NCT01986751|Primary|Mean Time to Onset of Sensory and Motor Block Between the Study Group and the Control Group|Mean time onset of sensory block and motor block between the study group and the control group to assess the efficacy of clonidine to prolong the block duration.|baseline to 72 hours|Study was prematurely terminated. No data were collected for this assessment.||||||
2616896|NCT01986686|Secondary|Recurrence and Treatment|Data will be collected on recurrence and treatment for recurrent diverticulitis|2 years|||||||
2616897|NCT01986686|Secondary|Post Operative Complications|Data will be collected on percent and type of complications for the surgery arm.|30 days|||||||
2616898|NCT01986686|Secondary|Readmission|Data will be collected on percent of patients who are readmitted for recurrence or postoperative complications during the follow-up period after enrollment.|30 days|||||||
2616899|NCT01986686|Secondary|Mortality|Data will be collected on percent of patients who die during the follow-up period after enrollment.|4 years|||||||
2616900|NCT01986686|Secondary|Measure Length of Hospital Stay for Surgery vs Non Surgery Patients|Data collected will include length of hospital stay from the date of admission to discharge day for nonoperative management of the first episode of Hinchey II diverticulitis.|4 years|||||||
2616901|NCT01986686|Primary|Primary Study Endpoint|The primary outcome measure is recurrent diverticulitis of the colon defined as an acute episode confirmed at CT scan and requiring hospitalization with IV antibiotics.|Minimum of 1 year after enrollment||||Participants|||Count of Participants
2616902|NCT01986647|Other Pre-specified|Attendance Rates|The number of participants attending 20 or more exercise classes|12 weeks||||Participants|||Count of Participants
2616903|NCT01986647|Secondary|Change in Narrow Walk Time From Baseline to 12 Weeks|Time to walk narrow pathway. Greater values (times) indicate poorer performance.|12 weeks||||seconds||Standard Deviation|Mean
2616904|NCT01986647|Secondary|Change in Stance Time Variability From Baseline to 12weeks|variability of individual stance times during walking as measured from a electronic walkway. Measured as the standard deviation of all stance times. greater values represent greater variability which is related to poorer outcomes.|12 week||||seconds||Standard Deviation|Mean
2616905|NCT01986647|Secondary|Change in Short Physical Performance Battery From Baseline to 12weeks|Short physical Performance Battery is a performance test that includes gait speed, 5 time sit to stand and standing balance. Scores range from 0-12 with greater scores indicating better performance.|12 week||||units on a scale||Standard Deviation|Mean
2616906|NCT01986647|Secondary|Change in Modified Gait Efficacy Scale From Baseline to 12 Weeks|Confidence in walking was measured by the modified gait efficacy scale (mGES). Scores range from 0-100 with higher scores indicating greater confidence.|12 weeks||||units on a scale||Standard Deviation|Mean
2616907|NCT01986647|Secondary|Change in Figure 8 Walk Test From Baseline to 12 Weeks|Time it takes to walk a figure 8 around 2 cones 5 feet apart. Greater time in seconds represents poorer performance|12 weeks||||seconds||Standard Deviation|Mean
2616908|NCT01986647|Secondary|Number of Participants Who Reported They Would Definitely or Probably Continue With the Program|Question from the satisfaction questionnaire.|12 weeks||||Participants|||Count of Participants
2616909|NCT01986647|Secondary|Number of Participants Who Reported They Were Satisfied or Very Satisfied With the Program.|Question from the satisfaction questionnaire.|12 weeks||||Participants|||Count of Participants
2616910|NCT01986647|Secondary|Number of Participants Who Reported That They Felt Safe or Very Safe During the Exercise.|Question from the satisfaction questionnaire.|12 weeks||||Participants|||Count of Participants
2616911|NCT01986647|Secondary|Number of Participants Reporting That They Received a Just Right Amount of Individualized Instruction|Question from satisfaction questionnaire - that asked participants their opinion on the amount of individualized instruction they received.|12 weeks||||Participants|||Count of Participants
2616912|NCT01986647|Secondary|Number of Participants Who Reported That the Class Was at Least Somewhat Challenging|Measured by question on the satisfaction questionnaire. Question asked participants to rate how challenging the class was.|12 weeks||||Participants|||Count of Participants
2616913|NCT01986647|Secondary|Number of Participants Who Reported They Benefited a Good Bit or Somewhat From the Class|Participant satisfaction will be measured by satisfaction surveys and personal interviews. Benefited from class a good bit or somewhat|12 weeks||||Participants|||Count of Participants
2616914|NCT01986647|Primary|Change in Six Minute Walk Distance From Baseline to 12 Weeks|distance walked in 6 minutes|12 weeks||||meters||Standard Error|Mean
2616915|NCT01986647|Primary|Change in Gait Speed From Baseline to 12 Weeks|Gait speed in m/s|12 weeks||||m/s||Standard Error|Mean
2616916|NCT01986647|Primary|Change in Self-reported Disability From Baseline to 12 Weeks|Late Life Function and Disability Instrument (LLFDI) disability frequency component. Scores range from 0-100 with higher scores representing better (less) disability.|12 weeks||||units on a scale||Standard Error|Mean
2616917|NCT01986647|Primary|Change in Self-reported Overall Function From Baseline to 12 Weeks|Late Life Function and Disability Index (LLFDI) overall function. Scores range from 0-100 with higher score representing better function.|baseline and 12 weeks||||units on a scale||Standard Error|Mean
2616929|NCT01986140|Other Pre-specified|Improved Quality of Life|Improved quality of life as a result of reduced hair loss is a primary motivator for developing the Paxman Scalp Cooling device. Quality of life will be assessed at baseline and 2-3 weeks after each course of chemotherapy. Three widely used and validated scales will be used: the EORTC QLQ C-30, HADS and BIS. Subjects will be evaluated at multiple time points and data will be analyzed using descriptive methods with median and inter quartile rang to assess the effect of treatment group and alopecia status on functioning, quality of life and depression.|4 to 8 Months|||||||
2616930|NCT01986140|Secondary|Time to First Recurrence and Overall Survival|A safety follow-up for safety data will be done yearly for 5 years looking at time to first recurrence of breast cancer, overall survival, site of first recurrence, and incidence of isolated scalp metastasis. This will be collected during routine clinical observation|5 years||2022-02-28|02/2022||||
2616918|NCT01986361|Secondary|Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Scale (STS) Over the 3 Hours Post-baseline (STS SPID3)|"The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: Circle the number that shows how sore your throat is now when you swallow. STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours, for a total of 24 post-dose measurements.~The time-weighted SPID combines relief magnitude (PID = change from baseline) as weighted by duration interval between ratings. SPID3 refers to measurements taken up to 3 hours post-baseline, and has a full range of -1332 (complete pain relief within 5 minutes of dosing that lasts for 3 hours) to 468 (drug escalates level of pain to a score of 10 and the pain stays at that level for 3 hours) using the mean baseline STS value 7.4 for this study."|Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1|Intent to treat|||units on a scale||95% Confidence Interval|Mean
2616919|NCT01986361|Secondary|Percentage of Participants With Perceived Pain Relief|Defined as the percentage of participants who pressed the first stopwatch during the 3 hour evaluation period.|up to 3 hours post dose on Day 1|Intent to treat|||percentage of participants||95% Confidence Interval|Number
2616920|NCT01986361|Secondary|Percentage of Participants With Meaningful Pain Relief|Defined as the percentage of participants who pressed the second stopwatch during the 3 hour evaluation period.|up to 3 hours post dose on Day 1|Intent to treat|||percentage of participants||95% Confidence Interval|Number
2616921|NCT01986361|Secondary|Change From Baseline at Individual Timepoints in Sore Throat Scale (STS)|"The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: Circle the number that shows how sore your throat is now when you swallow. The STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours."|Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1|Intent to treat|||units on a scale||Standard Deviation|Mean
2616922|NCT01986361|Secondary|Kaplan-Meier Estimates for Time of First Perceived Pain Reduction on the Sore Throat Scale (STS) Which is Followed by ≥ 20% Pain Reduction on the Sore Throat Pain Intensity Scale (STPIS)|"Time to pain reduction on the STS (defined as any reduction or decrease observed during the 3 hours post dose) for participants whose improvement was confirmed by a >=20% reduction in pain on the STPIS.~STS: The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: Circle the number that shows how sore your throat is now when you swallow. The STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours.~STPIS: The participant was instructed to swallow and: Place a line on the Sore Throat Scale that best characterizes the severity of your sore throat now: 0mm=no pain and 100mm=severe pain. The STPIS was obtained at baseline, after the participant depressed the second stopwatch, and at 1, 2, and 3 hours postdose."|Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1|Intent to treat|||minutes||95% Confidence Interval|Median
2616923|NCT01986361|Secondary|Kaplan-Meier Estimates for Time of First Indication of Sore Throat Relief as Measured By Any Reduction in the Sore Throat Scale (STS)|"Time to first indication of sore throat relief, defined as any reduction or decrease in STS observed during the 3 hours post dose. Participants who did not have any reduction in STS from baseline within 3 hours were censored to 3 hours.~The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: Circle the number that shows how sore your throat is now when you swallow. The STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours."|up to 3 hours post dose on Day 1|Intent to treat|||minutes||95% Confidence Interval|Median
2616924|NCT01986361|Secondary|Kaplan-Meier Estimates for Time to First Perceived Pain Relief That Is Confirmed By Meaningful Pain Relief|Time to first perceived pain relief on the first stopwatch that was confirmed by meaningful pain relief on the second stopwatch. Participants who had no meaningful pain relief within 3 hours from baseline were censored to 3 hours.|up to 3 hours post dose on Day 1|Intent to treat|||minutes||95% Confidence Interval|Median
2616925|NCT01986361|Secondary|Kaplan-Meier Estimates for Time of First Perceived Pain Relief|"Time to first perceived pain relief is a patient-reported outcome (PRO) captured as part of the double stopwatch method. Participants depress the first stop watch when they experience any pain relief, termed perceived pain relief. Instructions to participants are: Stop the first stopwatch when you first feel any sore throat pain relief whatsoever. This does not mean you feel completely better, although you might, but when you first feel any relief of the throat pain you have now. Participants who did not have perceived pain relief were censored at 3 hours."|up to 3 hours post dose on Day 1|Intent to treat|||minutes||95% Confidence Interval|Median
2616926|NCT01986361|Primary|Kaplan-Meier Estimates for Time to Meaningful Pain Relief|"Time to meaningful pain relief is a patient-reported outcome (PRO) captured as part of the double stopwatch method. Participants depress the second stop watch when they experience what they perceive as meaningful pain relief. Instructions to participants are: Stop the second stopwatch when the sore throat pain relief is meaningful to you. This does not mean you feel completely better, although you might, but when you feel relief of throat pain that is meaningful to you. Participants who did not have perceived pain relief were censored at 3 hours."|up to 3 hours post dose on Day 1|Intent to treat population|||minutes||95% Confidence Interval|Median
2616927|NCT01986231|Secondary|Assess Difference in Hepatic Glycogen Measured in the Fed State Before vs. After Repeated Glucagon Administration|The mean difference in estimated hepatic glycogen will be assessed using Carbon 13 Magnetic Resonance Spectroscopy before vs. after glucagon administration in the fed state.|Baseline and 41 hours||||g/L||Standard Deviation|Mean
2616928|NCT01986231|Primary|Assess Difference in Hepatic Glycogen Measured in the Fasting State Before vs. After Repeated Glucagon Administration|The mean difference in estimated hepatic glycogen will be assessed using Carbon 13 Magnetic Resonance Spectroscopy before vs. after glucagon administration in the fasting state.|Baseline and 41 hours||||g/L||Standard Deviation|Mean
2616959|NCT01985685|Secondary|Change in Central Venous Oxygen Saturation|Change in central venous oxygen saturation|6 hrs||||percent||Inter-Quartile Range|Median
2616960|NCT01985685|Secondary|Percentage Change in Serum Lactate|Percentage change in serum lactate|6 hrs||||percentage change||Inter-Quartile Range|Median
2616931|NCT01986140|Primary|Hair Preservation|The primary efficacy endpoint will be success in hair preservation, defined as CTCAE v 4 alopecia grade <2, and will be assessed by a healthcare professional who is blinded to study treatment.|4 to 8 Months|Randomized patients who underwent at least one cycle of chemotherapy were evaluable for efficacy. 27 patients in the cooling group and 25 patients in the non-cooling group did not start chemotherapy or discontinued during the 1st cycle were excluded from the efficacy analysis.|||Participants|||Count of Participants
2616932|NCT01986114|Secondary|Number of Subjects Who Experienced Recurrence/Relapse of Any Mood Event From Clinical Stability of Bipolar Disorder.|The number and percentage of subjects who experienced recurrence/relapse of any mood event from clinical stability of bipolar disorder.|Baseline to 52 weeks||||Participants|||Count of Participants
2616933|NCT01986114|Secondary|Change From Long Term Study Baseline to LOCF Endpoint in the Young Mania Rating Scale (YMRS) Total Score.|"YMRS (Young Mania Rating Scale) is a clinician-rated assessment of the severity of mania in subjects with a diagnosis of bipolar disorder.~The YMRS total score ranges from a minimum of 0 to a maximum of 60. For the YMRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The YMRS contains eleven (11) items. The total score is computed as the sum of the scores for the 11 items."|Baseline, 52 weeks and each month||||units on a scale||Standard Deviation|Mean
2616934|NCT01986114|Secondary|Change From Long Term Study Baseline to LOCF Endpoint in the Montgomery-Asberg Depression Rating Scale (MADRS) Score|"Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression.~The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items."|Baseline, 52 weeks and each month||||units on a scale||Standard Deviation|Mean
2616935|NCT01986114|Primary|Number of Subjects With at Least One Adverse Event (AE) and Adverse Drug Reaction (ADR)|The number and percentage of subjects with at least one adverse event and adverse drug reaction|28, 52 weeks||||Participants|||Count of Participants
2616936|NCT01986101|Secondary|Change From Baseline in the HAM-A Total Score at Week 6 (LOCF)|"The Hamilton Rating Scale for Anxiety (HAM-A) scale is a rating scale developed to quantify the severity of anxiety symptomatology.~The HAM-A total score ranges from a minimum of 0 to a maximum of 56. For the HAM-A total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The HAM-A contains fourteen (14) items. The total score is computed as the sum of the scores for the 14 items."|Baseline to 6 weeks|Intention-to-treat population is analyzed. Values were missing for some subjects.|||units on a scale||Standard Error|Least Squares Mean
2616937|NCT01986101|Secondary|Change From Baseline in the YMRS Total Score at Week 6|"YMRS (Young Mania Rating Scale) is a clinician-rated assessment of the severity of mania in subjects with a diagnosis of bipolar disorder.~The YMRS total score ranges from a minimum of 0 to a maximum of 60. For the YMRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The YMRS contains eleven (11) items. The total score is computed as the sum of the scores for the 11 items."|Baseline to 6 weeks|Intention-to-Treat Population is analyzed.|||units on a scale||Standard Error|Least Squares Mean
2616938|NCT01986101|Secondary|Change From Baseline in the SDS Total Score at Week 6 (LOCF)|"Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of functional impairment in work/school, social life and family life/home responsibilities.~The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items."|Baseline to 6 weeks|Intention-to-Treat Population is analyzed. Values were missing for some subjects.|||units on a scale||Standard Error|Least Squares Mean
2616939|NCT01986101|Secondary|Change From Baseline in the CGI-BP-S (Depression) Score at Week 6|"Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression.~The CGI depression score ranges from a minimum of 1 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome."|Baseline to 6 weeks|Intention-to-treat population is analyzed.|||units on a scale||Standard Error|Least Squares Mean
2616940|NCT01986101|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6|"Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression.~The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.~The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items."|Baseline to 6 weeks|Intention-to-treat population is analyzed.|||units on a scale||Standard Error|Least Squares Mean
2616941|NCT01986062|Secondary|PERM-P Scores - Number of Problems Correct|Permanent Product Measure of Performance (PERMP) assessments measured during Laboratory Classroom Days. The PERMP is an individualized, five-page math exam consisting of 400 problems. Subjects are instructed to complete as many math problems as possible in 10 minutes. Performance is evaluated using the number of problems attempted (maximum score = 400) and the number of problems correct (maximum score = 400).|0.75, 2, 4, 6, 8, and 10 hours post-dose|ITT|||number of problems correct||Standard Deviation|Mean
2616942|NCT01986062|Secondary|PERM-P Scores - Number of Problems Attempted|Permanent Product Measure of Performance (PERMP) assessments measured during Laboratory Classroom Days. The PERMP is an individualized, five-page math exam consisting of 400 problems. Subjects are instructed to complete as many math problems as possible in 10 minutes. Performance is evaluated using the number of problems attempted (maximum score = 400) and the number of problems correct (maximum score = 400).|0.75, 2, 4, 6, 8, and 10 hours post-dose|ITT|||number of problems attempted||Standard Deviation|Mean
2616943|NCT01986062|Secondary|SKAMP Subscale - Deportment Scores|The SKAMP scale is a validated subjective measure of ADHD symptoms. It is comprised of 13 items (grouped under the subcategories of attention, deportment, quality of work, and compliance) on which subjects are rated according to a 7-point scale (0 = normal to 6 = maximal impairment). The SKAMP-Deportment subscale score is comprised of four of the 13 items with a maximum score of 24.|0.75, 2, 4, 6, 8, and 10 hours post-dose||||units on a scale||Standard Deviation|Mean
2616944|NCT01986062|Secondary|SKAMP Subscale - Attention Scores|The SKAMP scale is a validated subjective measure of ADHD symptoms. It is comprised of 13 items (grouped under the subcategories of attention, deportment, quality of work, and compliance) on which subjects are rated according to a 7-point scale (0 = normal to 6 = maximal impairment). The SKAMP-Attention subscale score is comprised of four of the 13 items with a maximum score of 24.|0.75, 2, 4, 6, 8, and 10 hours post-dose||||units on a scale||Standard Deviation|Mean
2616945|NCT01986062|Secondary|SKAMP-Combined Scores|Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale [SKAMP]-combined scores measured during Laboratory Classroom Days. The SKAMP scale is a validated subjective measure of ADHD symptoms in a laboratory classroom, comprised of 13 items on which subjects are rated according to a 7 point scale (0=normal to 6=maximal impairment); maximum score 78. The SKAMP-combined score is obtained by summing the rating values for each of the 13 items, whereby the higher the SKAMP score, the greater the impairment.|0.75, 4, 6, 8, 10 hours post-dose||||units on a scale||Standard Deviation|Mean
2616946|NCT01986062|Primary|SKAMP-Combined Scores|Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale [SKAMP]-combined scores measured during Laboratory Classroom Days. The SKAMP scale is a validated subjective measure of ADHD symptoms in a laboratory classroom, comprised of 13 items on which subjects are rated according to a 7 point scale (0=normal to 6=maximal impairment); maximum score 78. The SKAMP-combined score is obtained by summing the rating values for each of the 13 items, whereby the higher the SKAMP score, the greater the impairment.|2 hours post-dose|ITT Population|||units on a scale||Standard Deviation|Mean
2616947|NCT01985971|Primary|Number of Participants With Adverse Events||2 year||||Participants|||Count of Participants
2616948|NCT01985958|Primary|Number of Participants With Adverse Events||One Year||||Participants|||Count of Participants
2616949|NCT01985932|Primary|Number of Participants With Adverse Events||2 years||||Participants|||Count of Participants
2616950|NCT01985763|Secondary|Overall Survival (OS)|Overall Survival - Number of months still living since baseline|up to 50 months||||months||95% Confidence Interval|Median
2616951|NCT01985763|Secondary|Percent of Patients With Progression Free Survival (PFS) at 6 Months and 12 Months|"Patients monitored for progression during the study period and 1 year following.~Progression-free survival (PFS) is the length of time during and after the treatment that a patient lives with the disease but it does not get worse."|6 month and 12 month||||percentage of participants||95% Confidence Interval|Number
2616952|NCT01985763|Secondary|Progression Free Survival (PFS)|Patients monitored for progression. Progression-free survival (PFS) is the length of time during and after the treatment that a patient lives with the disease but it does not get worse.|up to 50 months||||months||95% Confidence Interval|Median
2616953|NCT01985763|Secondary|Number of Participants With Best Overall Response Rate (ORR)|The number of participants with best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.|up to 50 months||||Participants|||Count of Participants
2616954|NCT01985763|Secondary|Best Overall Response Rate RECIST Criteria|"Best Overall Response Rate (ORR) as measured by radiologic RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.~SD - target lesion SD, non target lesions Non-PD, and no new lesions. PR - target lesion CR, non target lesions Incomplete response/SD and no new lesions; or target lesion PR, non target lesions Non-PD, and no new lesions.~PD - target lesions PD, non target lesions Any, can have new lesions; or target lesions Any, non target lesions PD, can have new lesions; or target lesions Any, non target lesions Any, have new lesions."|up to 50 months||||Participants|||Count of Participants
2616955|NCT01985763|Secondary|Number of Participants With an Overall Response Rate (ORR)|Number of participants with an ORR - the portion of patients with a tumor size reduction of a predefined amount for a minimum time period|up to 50 months||||Participants|||Count of Participants
2616956|NCT01985763|Secondary|Response Rate RECIST Criteria|"Response Rate (RR) as measured by radiologic RECIST criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|end of Cycle 6||||Participants|||Count of Participants
2616957|NCT01985763|Primary|Percent Change in Tumor Size|Percent change in tumor size after cycle 6. Each cycle is 21 days.|end of Cycle 6||||Percent change||95% Confidence Interval|Median
2616958|NCT01985763|Primary|Number of Adverse Events|Number of adverse events to assess tolerability of genistein treatment. Evaluation of side effects conducted every 14 days before each chemotherapy/genistein cycle.|up to 6 months||||events|||Number
2616962|NCT01985581|Secondary|Evaluate the Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in Clinical Global Impression of Improvement (CGI-I) Scale|CGI-I is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Subjects who felt very much improved or much improved are considered improved.The outcome measure is reporting the percentage of participants showing improvement|comparison from baseline to end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.|||percentage of subjects|||Number
2616963|NCT01985581|Secondary|Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change on the Clinical Global Impression of Severity (CGI-S) Scale|The Clinical Global Impression- Severity scale is a scale of illness ranging from 1 (normal) to 7 (among the most severely ill patients). Subjects who felt normal, not at all ill or borderline mentally ill are considered improved. The outcome measure is reporting the percentage of participants showing improvement|comparison from baseline to end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.|||percentage of subjects|||Number
2616964|NCT01985581|Secondary|Evaluate the Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Parent Questionnaire.|The KINDL is a quality of life questionnaire of 24 items completed by the parent (KINDL-parent). It is a generic instrument for assessing Health Related quality of life in children and adolescents aged 3 years and older. Norm values are given based on representative German data from the German National Health Interview and Examination Survey for Children and Adolescents (KiGGS) study, a broad survey realized by the German Robert-Koch Institute. The KINDL scores were converted to range between 0 and 100 with higher scores indicating better quality of life as reported by the parent.|Measured at baseline and end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.|||units on a scale||Standard Error|Mean
2616965|NCT01985581|Secondary|Subjects Experiencing Suicidal Ideation, Suicidal Behaviour and Self-injurious Behaviour Without Suicidal Intent and Incident of Serious Adverse Events in Each Treatment Arm|To compare the number of subjects experiencing suicidal ideation, suicidal behaviour and self-injurious behaviour without suicidal intent as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) and incident of Serious Adverse Events (SAEs) in each treatment arm|Measured up to 30 weeks|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.|||subjects|||Number
2616966|NCT01985581|Secondary|Effect of Adjunct Therapy on ADHD Symptom Control as Assessed by the Change in the ADHD Rating Scale (ADHD-RS-IV)|The ADHD-RS-IV is completed by the Investigator familiar with the scale. It is an 18 item scale designed to reflect current symptomatology of ADHD based on the DSM-5 criteria. Each item is scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, with higher scores reflecting more severe symptoms|comparison from baseline to end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.|||units on a scale||Standard Error|Mean
2616967|NCT01985581|Secondary|Effect of Adjunctive INTUNIV Extended Release Treatment on Change in Quality of Life as Assessed by the KINDL®-Child Questionnaire.|The KINDL is a quality of life questionnaire of 24 items completed by the subject (KINDL-child). It is a generic instrument for assessing Health Related quality of life in children and adolescents aged 3 years and older. Norm values are given based on representative German data from the German National Health Interview and Examination Survey for Children and Adolescents (KiGGS) study, a broad survey realized by the German Robert-Koch Institute. The KINDL scores were converted to range between 0 and 100 with higher scores indicating better quality of life as reported by the child|Measured at baseline and end of each 12 week treatment arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline questionnaire during either period 1 or period 2.|||units on a scale||Standard Error|Mean
2616968|NCT01985581|Primary|Effect of Adjunctive INTUNIV Extended Release Treatment on Executive Function as Assessed by Change From Baseline on the BRIEF-parent Questionnaires|The Behavioural Rating Inventory of Executive Function (BRIEF) was developed to assess such real-world expressions of executive function in the home (BRIEF-P) as assessed by the parent. This is an 86 item questionnaire completed by the parents. The score is converted to a t-score with a score less than 65 being considered within the normal range. Higher scores are worsening in function.|measured at baseline and end of each 12 week treament arm|ITT population - consisting of subjects who took at least one dose of treatment and completed at least one non-baseline BRIEF questionnaire during either period 1 or period 2.|||units on a scale||Standard Error|Mean
2616969|NCT01985425|Secondary|Post-operative Infection||Post-operative Day 1 until Postoperative Day 30||||Participants|||Count of Participants
2616970|NCT01985425|Secondary|Transient Ischemic Attack (TIA)|New focal neurological deficit thought to be vascular in origin with signs and symptoms lasting less than 24 hours.|Post-operative Day 1 until Postoperative Day 30||||Participants|||Count of Participants
2616971|NCT01985425|Secondary|Stroke|New focal neurological deficit thought to be vascular in origin with signs and symptoms lasting more than 24 hours and cerebral imaging consistent with acute stroke.|Post-operative Day 1 until Postoperative Day 30||||Participants|||Count of Participants
2616972|NCT01985425|Secondary|Myocardial Injury After Non-Cardiac Surgery (MINS)|"Requires one of the following criteria:~A) Elevated troponin or CK-MB measurement with one or more of the following defining features:~Ischemic signs or symptoms (i.e., chest, arm, neck, or jaw discomfort; shortness of breath, pulmonary edema);~Development of pathologic Q waves present in any two contiguous leads that are >30 milliseconds;~Electrocardiogram (ECG) changes indicative of ischemia (i.e., ST segment elevation [>2 mm in leads V1, V2, or V3 OR >1 mm in the other leads], ST segment depression [>1 mm], OR symmetric inversion of T waves >1 mm) in at least two contiguous leads;~New LBBB; or v. new or presumed new cardiac wall motion abnormality on echocardiography or new or presumed new fixed defect on radionuclide imaging;~B) Elevated troponin measurement after surgery with no alternative explanation (e.g., pulmonary embolism, sepsis) to myocardial injury"|Post-operative Day 1 until Postoperative Day 30||||Participants|||Count of Participants
2616975|NCT01985425|Primary|Clinically Significant Atrial Fibrillation|New atrial fibrillation that results in angina, congestive heart failure, symptomatic hypotension, or that requires treatment with a rate controlling drug, antiarrhythmic drug, or electrical cardioversion, or that lasts for longer than 30 seconds.|Post-operative Day 1 until Postoperative Day 30||||Participants|||Count of Participants
2616976|NCT01985334|Secondary|Mean Change From Baseline Reported Symptoms of COPD for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC|Patient-reported symptoms of COPD combined will be measured using eDiary data reported over the 12 week treatment period. The mean total symptom scores and mean individual symptom scores for the patient were calculated for the whole study period. The mean change from baseline in the total scores and in the individual scores were summarized by treatment and were analyzed for the percentage of nights with no nighttime awakenings and percentage of days with no symptoms.|Baseline, 12 weeks|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups|||Percentage of days||Standard Deviation|Mean
2616977|NCT01985334|Secondary|Mean Number of Puffs of Rescue Medication Use for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC|Mean number of puffs of rescue medication use will be measured using eDiary data over 12 weeks of treatment.|12 weeks|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups|||Number of puffs||Standard Deviation|Mean
2616978|NCT01985334|Secondary|Change From Baseline on Total Score of Clinical COPD Questionnaire (CCQ) for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC|"The Clinical COPD Questionnaire (CCQ) is a self-administered 10-item questionnaire developed to measure clinical control in patients with COPD. Patients will be instructed to recall their experiences during the previous week. They respond to each question using a 7-point scale from 0 = asymptomatic/no imitation to 6 = extremely symptomatic/totally limited. The questionnaire is divided into 3 domains (symptoms [items 1, 2, 5, and 6] functional [items 7, 8, 9, and 10] and mental state [items 3 and 4]). The overall clinical COPD control score and the scores of the domains are calculated by adding all the scores together and dividing this sum by the number of questions.~Thus, the overall clinical COPD control score as well as the score on each of the three domains varies between 0 (very good control) to 6 (extremely poor control)."|Day 1 (baseline) and Week 12|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups|||Score||Standard Deviation|Mean
2616979|NCT01985334|Secondary|Change From Baseline on Total Score of COPD Assessment Test (CAT) for Groups: Glycopyrronium and Indacaterol Maleate and Glycopyrronium Bromide FDC|Total score of COPD Assessment Test (CAT) will be measured at baseline and at week 12. This questionnaire is completed by the patient. The score ranges from 0-40 where higher scores represent worse health status. CAT scores ≥ 10 are associated with significantly impaired health status.|Day 1 (baseline) and Week 12|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups|||Score||Standard Deviation|Mean
2616980|NCT01985334|Secondary|Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC|Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.|Day 1 (baseline) and week 12|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups|||Score on a scale||95% Confidence Interval|Least Squares Mean
2616981|NCT01985334|Secondary|Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA or LAMA Monotherapy or LABA and ICS in Free or FDC on Trough FEV1 at Week 12.|Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.|12 Weeks|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups|||Liters||95% Confidence Interval|Least Squares Mean
2616982|NCT01985334|Secondary|Change From Baseline on on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) or Long-acting Bronchodilators (LABA or LAMA Monotherapy)|Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.|Day 1 (baseline) and week 12|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups|||Score on a scale||95% Confidence Interval|Least Squares Mean
2616993|NCT01985321|Primary|Clinician Assessed Duration of Complete Healing of the Herpetic Episode||Days 1-14|Modified Intent to Treat Population: 2 subjects in placebo group violated protocol and could not be evaluated for Complete Healing (83-2=81). 5 subjects in active group started treatment prior to contacting site; 1 subject in active group lost to follow-up with no site visits. These 6 active subjects not used in Complete Healing analysis (90-6=84)|||hours||Full Range|Median
2616983|NCT01985334|Secondary|Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) or vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)|Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval|12 Weeks|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups|||Liters||95% Confidence Interval|Least Squares Mean
2616984|NCT01985334|Primary|Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)|Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.|Day 1 (baseline) and week 12|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups|||Units on a scale||95% Confidence Interval|Least Squares Mean
2616985|NCT01985334|Primary|Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC|Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.|Day 1 (baseline) and week 12|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups|||Units on a scale||95% Confidence Interval|Least Squares Mean
2616986|NCT01985334|Primary|Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)|Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.|Day 1 (baseline) and week 12|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups|||Units on a scale||95% Confidence Interval|Least Squares Mean
2616987|NCT01985334|Primary|Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)|Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.|Day 1 (baseline) and week 12|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups|||Units on a scale||95% Confidence Interval|Least Squares Mean
2616988|NCT01985334|Primary|Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)|Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.|Week 12 (Visit 4)|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups|||Liters||95% Confidence Interval|Least Squares Mean
2616989|NCT01985334|Primary|Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC|Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval.|Week 12 (Visit 4)|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups|||Liters||95% Confidence Interval|Least Squares Mean
2616990|NCT01985334|Primary|Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy)|Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval|Week 12 (Visit 4)|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups|||Liters||95% Confidence Interval|Least Squares Mean
2616991|NCT01985334|Primary|Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC)|Trough FEV1 at visit 4 is defined as FEV1, computed as the mean of forced expiratory volume in 1 second 15min and 45 min pre dose measurements, at the end of the dosing interval|Week 12 (Visit 4)|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and who were getting the appropriate medication, be it glycopyrronium, indacaterol + glycopyrronium or comparative treatment (baseline therapy) in the respective comparisons of the different groups|||Liters||95% Confidence Interval|Least Squares Mean
2616994|NCT01985126|Secondary|Time to Disease Progression|Time to progression was defined as the number of days from the date of first dose of daratumumab to the date of first record of disease progression.|Up to 14.4 Months|All treated analysis set included all participants who received at least 1 dose of daratumumab.|||months||95% Confidence Interval|Median
2616995|NCT01985126|Secondary|Progression Free Survival|Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first.|Up to 14.4 Months|All treated analysis set included all participants who received at least 1 dose of daratumumab.|||months||95% Confidence Interval|Median
2616996|NCT01985126|Secondary|Time to Response|Time to response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better).|Up to 14.4 Months|Responders in all treated analysis set. Only those participants with confirmed PR were analyzed.|||months||Full Range|Median
2616997|NCT01985126|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit rate defined as percentage of participants who achieved minimal response (MR) or better. MR: >=25% but <= 49% reduction of serum M-protein and reduction in urine M-protein by 50%-89%. If present at baseline 25% to 49% reduction in size of soft tissue plasmacytomas.|Up to 14.4 Months|All treated analysis set included all participants who received at least 1 dose of daratumumab.|||percentage of participants||95% Confidence Interval|Number
2616998|NCT01985126|Secondary|Overall Survival|Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.|Approximately up to 3 years|All treated analysis set included all participants who received at least 1 dose of daratumumab.|||months||95% Confidence Interval|Median
2616999|NCT01985126|Secondary|Duration of Response|Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in IMWG criteria. Disease progression (IMWG criteria): increase of 25 percent (%) from lowest response level in Serum M-component (the absolute increase must be >=0.5 g/dL) and/or; urine M-component (the absolute increase must be >=200 mg/24 hours) and/or; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels (absolute increase must be >10 milligram per deciliter (mg/dL); Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 millimole per liter [mmol/L]) that can be attributed solely to the plasma cell proliferative disorder.|Up to 14.4 Months|Responders in all treated analysis set. Only those participants with confirmed PR and those who experienced progressive disease were analyzed.|||months||95% Confidence Interval|Median
2617000|NCT01985126|Primary|Percentage of Participants With Overall Response|Overall response defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). Per IMWG criteria, sCR: is defined as normal free light chain (FLC) ratio, and absence of clonal plasma cells (PCs) by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5 % plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein plus urine M-protein level < 100mg/24 hours; PR: >= 50 % reduction of serum M-protein and reduction in 24 hour urinary M-protein by >= 90% or to <200 mg/24 hours; if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria.|Up to 14.4 Months|All treated analysis set included all participants who received at least 1 dose of daratumumab.|||percentage of participants||95% Confidence Interval|Number
2617001|NCT01984892|Other Pre-specified|Overall Survival in Treated Patients|Patients who are alive on the date of closing follow-up, or 30 months after completing all study treatments, will be censored on that date|up to 30 months||||Participants|||Count of Participants
2617002|NCT01984892|Secondary|Therapeutic Effect in Treated Patients|Induction of innate and/or an adaptive, specific anti-tumor T cell immune response in the injected tumor lesion and also systemically.|24 months|study terminated early, data not collected. study terminated before all study visits completed. this 24 month visit was not done.||||||
2617003|NCT01984892|Primary|Progression-free Survival|"Progression-free survival defined as the time in weeks from study entry until tumor progression defined using the Wolchok criteria or death. Patients who are alive and free from progression on the date of closing follow-up will be censored on that date.~In order to minimize the potential for misdiagnosis of pseudoprogression, related to early inflammation, tumor measurement for determination of progression will be made at the earliest at 26 weeks."|average 52 weeks||||weeks|||Number
2617004|NCT01984697|Other Pre-specified|Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36|Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively. These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay.|Month 36|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
2617005|NCT01984697|Other Pre-specified|Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 36|Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|Month 36|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
2617042|NCT01984424|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
2617006|NCT01984697|Other Pre-specified|Antibody Persistence: Percentage of Participants With Seroconversion to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24|Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Seroconversion to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were defined as a titer >=41, 24, 34, 39, 24, 18, 12, 16, and 12 mMU/mL, respectively. These cutoffs differ from analyses performed on samples collected up to Month 13; the antibody persistence analysis employed a new version of the assay.|Month 24|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
2617007|NCT01984697|Other Pre-specified|Antibody Persistence: Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 24|Antibodies to HPV VLP types were measured using a competitive Luminex immunoassay. This outcome measure assessed the long-term persistence of antibody response. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|Month 24|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV types, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
2617008|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 58 was defined as a titer >=8 mMU/mL.|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
2617009|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 52 was defined as a titer >=8 mMU/mL.|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
2617010|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 45 was defined as a titer >=8 mMU/mL.|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
2617011|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 33 was defined as a titer >=8 mMU/mL.|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
2617012|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 31 was defined as a titer >=10 mMU/mL.|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
2617013|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 18 was defined as a titer >=24 mMU/mL.|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
2617014|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 16 was defined as a titer >=20 mMU/mL.|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
2617043|NCT01984424|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 22 and 24||Baseline and weeks 22 and 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
2617044|NCT01984424|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
2617015|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 11 was defined as a titer >=16 mMU/mL.|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
2617016|NCT01984697|Primary|Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
2617017|NCT01984697|Primary|Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
2617018|NCT01984697|Primary|Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
2617019|NCT01984697|Primary|Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
2617020|NCT01984697|Primary|Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
2617021|NCT01984697|Primary|Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
2617022|NCT01984697|Primary|Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
2617023|NCT01984697|Primary|Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
2617024|NCT01984697|Secondary|Percentage of Participants With Seroconversion to HPV Type 6 at Four Weeks After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV VLP type 6 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 6 was defined as a titer >=30 mMU/mL.|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||Percentage of participants||95% Confidence Interval|Number
2617045|NCT01984424|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 22 and 24||Baseline and weeks 22 and 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
2617025|NCT01984697|Primary|Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen|Antibodies to HPV virus-like particles (VLP) type 6 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).|4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13)|All participants who 1) received all vaccinations in the planned regimen, 2) had a serum sample collected 4 weeks after the last vaccination in the planned regimen, 3) were seronegative at Day 1 for the relevant HPV type, and 4) had no protocol violations that would interfere with evaluation of the immune response.|||mMU/mL||95% Confidence Interval|Geometric Mean
2617026|NCT01984684|Secondary|Investigator-assessed Response of Signs and Symptoms of Infection at the Late Follow-up Visit|"A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.~A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing)."|Study Day 21 to 28||||Participants|||Count of Participants
2617027|NCT01984684|Secondary|Investigator-assessed Response of Signs and Symptoms of Infection at the Follow up Visit (European Medicines Agency [EMA] Primary Endpoint)|"A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.~A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing)."|Study Day 14 ± 1|ITT Population|||Participants|||Count of Participants
2617028|NCT01984684|Primary|Objective Response of ≥20% Reduction in Lesion Erythema Area Compared to Baseline at 48 to 72 Hours After Initiation of Treatment as Determined by Digital Measurements of the Leading Edge.|A patient was considered a responder if s/he had a ≥20% reduction in size of the area of erythema associated with the baseline ABSSSI, as determined by digital planimetry of the leading edge and had none of the reasons for clinical failure; a patient was considered a non-responder (failure) if s/he had <20% reduction in size of the area of erythema associated with the baseline ABSSSI as determined by digital planimetry of the leading edge, or had major intervention such as another antibiotic or surgical intervention or died within 74 hours after initiation of study drug.|48 to 72 hrs after starting treatment|ITT Population|||Participants|||Count of Participants
2617029|NCT01984515|Secondary|Patient Health Questionnaire-9 Item|9 symptoms of depression are measured on a 0-3 scale. Total scale range is 0-27, with higher scores indicating worse depression.|Referral Management Initiation, 1 month post initiation, 3 months post initiation||||units on a scale||Standard Deviation|Mean
2617030|NCT01984515|Secondary|PTSD Checklist-Specific|Measures the 17 symptoms of PTSD according to the DSM-IV. Scale for each item ranges from 1-5. Total scale score ranges from 17-85. 17 represents no PTSD symptoms and 85 represented the most severe PTSD symptoms.|Referral Management Initiation, 1 month post initiation, 3 months post initiation||||units on a scale||Standard Deviation|Mean
2617031|NCT01984515|Primary|Engagement in Evidence-based Psychotherapy for PTSD|Engagement will be assessed by how many patients attend at least 2 sessions of an evidence-based psychotherapy for PTSD and how many complete treatment. Completion is defined as 8 sessions.|From initiation of the Referral Management System to 6 months after initiation||||participants|||Number
2617032|NCT01984424|Secondary|Percent Change From Baseline in VLDL-C at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
2617033|NCT01984424|Secondary|Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 22 and 24||Baseline and weeks 22 and 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
2617034|NCT01984424|Secondary|Percent Change From Baseline in HDL-C at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
2617035|NCT01984424|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 24||Baseline and weeks 22 and 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
2617036|NCT01984424|Secondary|Percent Change From Baseline in Triglycerides at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
2617037|NCT01984424|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 22 and 24||Baseline and weeks 22 and 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
2617038|NCT01984424|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
2617039|NCT01984424|Secondary|Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 22 and 24||Baseline and Weeks 22 and 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
2617040|NCT01984424|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24||Baseline and week 24|Participants randomized and dosed in Part B of the study|||percent change||Standard Error|Least Squares Mean
2617041|NCT01984424|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 22 and 24||Baseline and Weeks 22 and 24|Participants randomized and dosed in Part B of the study.|||percent change||Standard Error|Least Squares Mean
2617058|NCT01984294|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2617059|NCT01984294|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 8 weeks|Full Analysis Set|||percentage of participants|||Number
2617060|NCT01984294|Secondary|Percentage of Participants With Sustained Virologic Response at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)|SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA < LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 2, 4, 8, and 24|Full Analysis Set|||percentage of participants|||Number
2617061|NCT01984294|Primary|Percentage of Participants Permanently Discontinuing Any Study Drug Due to an Adverse Event||Up to 8 weeks|Safety Analysis Set: participants were randomized and received at least one dose of study drug.|||percentage of participants|||Number
2617062|NCT01984294|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants were randomized and received at least one dose of study drug.|||percentage of participants|||Number
2617063|NCT01984242|Other Pre-specified|EuroQoL 5 Dimension (EQ-5D) Questionnaire Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Days 1 and 22 of Cycles 1 to 24; Day 1 of Cycle 25; treatment discontinuation (up to approximately 2.75 years) (1 cycle=6 weeks)|As this outcome was pre-specified as an exploratory outcome, no results are reported.||||||
2617064|NCT01984242|Secondary|Brief Fatigue Inventory (BFI) Fatigue Level Score|BFI questionnaire comprises of 2 parts: fatigue level (3 items), interference with daily life (1 item with 6 sub-items). Each items in the fatigue level score was answered on a scale of 0 (no fatigue) to 10 (as bad as you can imagine). The mean score of all 3 items was reported on the scale of 0 (no fatigue) to 10 (as bad as you can imagine).|Days 1 and 22 of Cycles 1 to 24; Day 1 of Cycle 25; treatment discontinuation (up to approximately 2.75 years) (1 cycle=6 weeks)|PRO-evaluable population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure. ‘Number Analyzed’=participants evaluable for this outcome measure at specified timepoint for each arm respectively.|||units on a scale||Standard Deviation|Mean
2617065|NCT01984242|Secondary|M.D. Anderson Symptom Inventory (MDASI) Interference Score|MDASI questionnaire comprises of 2 parts: symptoms (16 items), interference with daily life (6 items). Participants were asked to rate how much their symptoms interfered with general activity, mood, work, relations with other people, walking, and enjoyment of life during the last 24 hours. Each item in the interference score was answered on a scale of 0 (did not interfere) to 10 (interfered completely). The mean score of all 6 items was reported on the scale of 0 (did not interfere) to 10 (interfered completely).|Days 1 and 22 of Cycles 1 to 24; Day 1 of Cycle 25; treatment discontinuation (up to approximately 2.75 years) (1 cycle=6 weeks)|Patient Reported Outcome (PRO)-evaluable population: randomized participants who had non-missing baseline assessment and at least 1 post-baseline assessment. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome. ‘Number Analyzed’=participants evaluable for this outcome at specified timepoint for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2617066|NCT01984242|Secondary|Cmin of Bevacizumab||For Atezolizumab and Bevacizumab Arm: at First-line treatment discontinuation (up to approximately 2.75 years); For Crossover Arms: pre-infusion (0 hour) on Day 1 of Cycle 2 (1 cycle=6 weeks) (infusion length=30-90 minutes)|PK evaluable population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2617067|NCT01984242|Secondary|Cmax of Bevacizumab||30 minutes after end of infusion on Day 1 of Cycles 1 and 2 (1 cycle=6 weeks) (infusion length=30-90 minutes)|PK evaluable population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2617068|NCT01984242|Secondary|Minimum Serum Concentration (Cmin) of Atezolizumab||Pre-infusion (0 hour) on Day 1 of Cycles 2 and 4; Day 22 of Cycles 1, 2, and 4 (1 cycle=6 weeks) (infusion length=30-60 minutes)|PK evaluable population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure. ‘Number Analyzed’=participants evaluable for this outcome measure at specified timepoint for each arm respectively.|||mcg/mL||Standard Deviation|Mean
2617069|NCT01984242|Secondary|Maximum Serum Concentration (Cmax) of Atezolizumab||30 minutes after end of infusion on Cycle 1 Day 1 (1 cycle=6 weeks) (infusion length for first dose=60 minutes)|The pharmacokinetic (PK) evaluable population included participants who received at least one dose of study drug and had sufficient PK sample collected within the time specified in the protocol. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
2617070|NCT01984242|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Atezolizumab|This outcome measure was planned to be analyzed in 'Atezolizumab' and 'Atezolizumab and Bevacizumab' arms only.|Cycle 1 Day 1 until treatment discontinuation (until data cut-off date 17 October 2016, up to approximately 2.75 years) (1 cycle=6 weeks)|ATA evaluable population included participants at baseline who had a baseline ATA sample and post-baseline participants who had at least one ATA sample and had received at least one dose of study treatment.|||percentage of participants|||Number
2617118|NCT01984229|Secondary|Tmax of RO5468924: Cohort A|RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK analysis population [Cohort A]|||hours||Full Range|Median
2617071|NCT01984242|Secondary|PFS Per RECIST v.1.1 Via Investigator Assessment in Crossover Population|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.|From start of crossover treatment until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Crossover population|||months||95% Confidence Interval|Median
2617072|NCT01984242|Secondary|Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in Crossover Population|PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.|From start of crossover treatment until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Crossover population|||percentage of participants|||Number
2617073|NCT01984242|Secondary|DOR Per RECIST v1.1 Via Investigator Assessment in Crossover Population|DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate DOR.|From start of crossover treatment until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Crossover population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2617074|NCT01984242|Secondary|Percentage of Participants With Objective Response Per RECIST v1.1 Via Investigator Assessment in Crossover Population|Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits.|From start of crossover treatment until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Crossover population included participants in atezolizumab or sunitinib arms who had crossed over to the atezolizumab and bevacizumab arm. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2617075|NCT01984242|Secondary|OS in IC1/2/3 Population|OS was defined as the time from the date of randomization to the date of death due to any cause. Kaplan-Meier methodology was used to estimate OS.|Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||months||95% Confidence Interval|Median
2617076|NCT01984242|Secondary|Percentage of Participants Who Died in IC1/2/3 Population||Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||percentage of participants|||Number
2617077|NCT01984242|Secondary|Overall Survival (OS) in ITT Population|OS was defined as the time from the date of randomization to the date of death due to any cause. Kaplan-Meier methodology was used to estimate OS.|Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||months||95% Confidence Interval|Median
2617078|NCT01984242|Secondary|Percentage of Participants Who Died in ITT Population||Randomization until death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||percentage of participants|||Number
2617079|NCT01984242|Secondary|DOR Per Modified RECIST Via Investigator Assessment in IC1/2/3 Population|DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target and all new measurable lesions, taking as reference the baseline sum of diameters, in absence of CR. PD: at least a 20% increase in the sum of diameters of all target and new measurable lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm. Kaplan-Meier methodology was used to estimate DOR.|From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2617080|NCT01984242|Secondary|DOR Per Modified RECIST Via Investigator Assessment in ITT Population|DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target and all new measurable lesions, taking as reference the baseline sum of diameters, in absence of CR. PD: at least a 20% increase in the sum of diameters of all target and new measurable lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm. Kaplan-Meier methodology was used to estimate DOR.|From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2617119|NCT01984229|Secondary|Tmax of Alectinib: Cohort B||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort B]|||hours||Full Range|Median
2617081|NCT01984242|Secondary|DOR Per RECIST v1.1 Via Investigator Assessment in IC1/2/3 Population|DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate DOR.|From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2617082|NCT01984242|Secondary|DOR Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population|DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate DOR.|From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2617083|NCT01984242|Secondary|DOR Per RECIST v1.1 Via Investigator Assessment in ITT Population|DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate DOR.|From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2617084|NCT01984242|Secondary|Duration of Response (DOR) Per RECIST v1.1 Via IRC Assessment in ITT Population|DOR was defined as the time from first observation of an objective response (CR or PR) until first observation of PD. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate DOR.|From CR or PR until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population. ‘Overall Number of Participants Analyzed’=participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2617085|NCT01984242|Secondary|PFS Per Modified RECIST Via Investigator Assessment in IC1/2/3 Population|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of all target and new measurable lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||months||95% Confidence Interval|Median
2617086|NCT01984242|Secondary|Percentage of Participants With Disease Progression Per Modified RECIST Via Investigator Assessment or Death in IC1/2/3 Population|PD: at least a 20% increase in the sum of diameters of all target and new measurable lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||percentage of participants|||Number
2617087|NCT01984242|Secondary|PFS Per Modified RECIST Via Investigator Assessment in ITT Population|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of all target and new measurable lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||months||95% Confidence Interval|Median
2617088|NCT01984242|Secondary|Percentage of Participants With Disease Progression Per Modified RECIST Via Investigator Assessment or Death in ITT Population|PD: at least a 20% increase in the sum of diameters of all target and new measurable lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||percentage of participants|||Number
2617089|NCT01984242|Secondary|Percentage of Participants With Objective Response Per Modified RECIST Via Investigator Assessment in IC1/2/3 Population|Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target and all new measurable lesions, taking as reference the baseline sum of diameters, in absence of CR.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||percentage of participants||95% Confidence Interval|Number
2617090|NCT01984242|Secondary|Percentage of Participants With Objective Response Per Modified RECIST Via Investigator Assessment in ITT Population|Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target and all new measurable lesions, taking as reference the baseline sum of diameters, in absence of CR.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||percentage of participants||95% Confidence Interval|Number
2617091|NCT01984242|Secondary|Percentage of Participants With Objective Response Per RECIST v1.1 Via Investigator Assessment in IC1/2/3 Population|Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||percentage of participants||95% Confidence Interval|Number
2617092|NCT01984242|Secondary|Percentage of Participants With Objective Response Per RECIST v1.1 Via Investigator Assessment in ITT Population|Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||percentage of participants||95% Confidence Interval|Number
2617093|NCT01984242|Secondary|Percentage of Participants With Objective Response Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population|Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||percentage of participants||95% Confidence Interval|Number
2617094|NCT01984242|Secondary|Percentage of Participants With Objective Response (Complete Response [CR] or Partial Response [PR]) Per RECIST v1.1 Via IRC Assessment in ITT Population|Objective Response was defined as CR or PR. CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to less than (<) 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||percentage of participants||95% Confidence Interval|Number
2617095|NCT01984242|Secondary|PFS Per RECIST v1.1 Via Investigator Assessment in IC1/2/3 Population|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||months||95% Confidence Interval|Median
2617096|NCT01984242|Secondary|Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in IC1/2/3 Population|PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||percentage of participants|||Number
2617097|NCT01984242|Secondary|PFS Per RECIST v1.1 Via Investigator Assessment in ITT Population|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||months||95% Confidence Interval|Median
2617120|NCT01984229|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib: Cohort A||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK analysis population [Cohort A]|||hours||Full Range|Median
2617098|NCT01984242|Secondary|Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in ITT Population|PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||percentage of participants|||Number
2617099|NCT01984242|Secondary|PFS Per RECIST v1.1 Via Investigator Assessment in Participants Who Have Tumors With Higher Than the 33rd Percentile Expression of an Immune Gene Signature|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Biomarker evaluable population. Participants with higher than the 33rd percentile expression of an immune gene signature were included in this analysis.|||months||95% Confidence Interval|Median
2617100|NCT01984242|Secondary|Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in Participants Who Have Tumors With Higher Than the 33rd Percentile Expression of an Immune Gene Signature|PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Biomarker evaluable population. Participants with higher than the 33rd percentile expression of an immune gene signature were included in this analysis.|||percentage of participants|||Number
2617101|NCT01984242|Secondary|PFS Per RECIST v1.1 Via IRC Assessment in Participants Who Have Tumors With Higher Than the 33rd Percentile Expression of an Immune Gene Signature|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Biomarker evaluable population. Participants with higher than the 33rd percentile expression of an immune gene signature were included in this analysis.|||months||95% Confidence Interval|Median
2617102|NCT01984242|Secondary|Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Participants Who Have Tumors With Higher Than the 33rd Percentile Expression of an Immune Gene Signature|PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Biomarker evaluable population. Participants with higher than the 33rd percentile expression of an immune gene signature were included in this analysis.|||percentage of participants|||Number
2617103|NCT01984242|Secondary|PFS Per RECIST v1.1 Via Investigator Assessment in Participants Who Have Tumors With Higher Than Median Expression of an Immune Gene Signature|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Biomarker evaluable population. Participants with higher than median expression of an immune gene signature were included in this analysis.|||months||95% Confidence Interval|Median
2617104|NCT01984242|Secondary|Percentage of Participants With Disease Progression Per RECIST v1.1 Via Investigator Assessment or Death in Participants Who Have Tumors With Higher Than Median Expression of an Immune Gene Signature|PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Biomarker evaluable population. Participants with higher than median expression of an immune gene signature were included in this analysis.|||percentage of participants|||Number
2617105|NCT01984242|Secondary|PFS Per RECIST v1.1 Via IRC Assessment in Participants Who Have Tumors With Higher Than Median Expression of an Immune Gene Signature|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Biomarker evaluable population. Participants with higher than median expression of an immune gene signature were included in this analysis.|||months||95% Confidence Interval|Median
2617121|NCT01984229|Secondary|AUC0-inf of RO5468924: Cohort B|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||h*ng/mL||Standard Deviation|Mean
2617106|NCT01984242|Secondary|Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Participants Who Have Tumors With Higher Than Median Expression of an Immune Gene Signature|PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|Biomarker evaluable population included ITT participants whose tumor samples had sufficient material available for gene signature expression analyses. Participants with higher than median expression of an immune gene signature were included in this analysis.|||percentage of participants|||Number
2617107|NCT01984242|Primary|PFS Per RECIST v1.1 Via IRC Assessment in IC1/2/3 Population|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population|||months||95% Confidence Interval|Median
2617108|NCT01984242|Primary|Percentage of Participants With Disease Progression Per RECIST v1.1 Via IRC Assessment or Death in Immune Cell 1/2/3 (IC1/2/3) Population|PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|IC1/2/3 population included ITT participants with programmed death-ligand 1 (PD-L1) expression of greater than or equal to (>=) 1% on tumor-infiltrating immune cells.|||percentage of participants|||Number
2617109|NCT01984242|Primary|Progression-Free Survival (PFS) Per RECIST v1.1 Via IRC Assessment in ITT Population|PFS was defined as the time from randomization to the first occurrence of PD or death due to any cause. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 mm; appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions. Kaplan-Meier methodology was used to estimate PFS.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||months||95% Confidence Interval|Median
2617110|NCT01984242|Primary|Percentage of Participants With Disease Progression Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Via Independent Review Committee (IRC) Assessment or Death in Intent-to-Treat (ITT) Population|Progressive Disease (PD): at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, and an absolute increase of at least 5 millimeters (mm); appearance of one or more new target or non-target lesions; or unequivocal progression of existing non-target lesions.|From randomization until disease progression or death due to any cause (until data cut-off date 17 October 2016, up to approximately 2.75 years)|ITT population|||percentage of participants|||Number
2617111|NCT01984229|Secondary|t1/2 of RO5468924: Cohort B|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||hours||Standard Deviation|Mean
2617112|NCT01984229|Secondary|t1/2 of RO5468924: Cohort A|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK analysis population [Cohort A]. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Standard Deviation|Mean
2617113|NCT01984229|Secondary|t1/2 of Alectinib: Cohort B|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||hours||Standard Deviation|Mean
2617114|NCT01984229|Secondary|Terminal Half-life (t1/2) of Alectinib: Cohort A|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK analysis population [Cohort A]|||hours||Standard Deviation|Mean
2617115|NCT01984229|Secondary|Metabolite/Parent Ratio for Cmax: Cohort B|RO5468924 is M4 metabolite of Alectinib. The ratio is molecular weight adjusted.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||ratio||Standard Deviation|Geometric Mean
2617116|NCT01984229|Secondary|Metabolite/Parent Ratio for AUC0-inf: Cohort B|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of Alectinib. The ratio is molecular weight adjusted.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||ratio||Standard Deviation|Geometric Mean
2617117|NCT01984229|Secondary|Tmax of RO5468924: Cohort B|RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||hours||Full Range|Median
2620549|NCT01954160|Secondary|LV End Systolic Dimension (LVESd)|Echo: LV end systolic dimension (LVESd)|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2617122|NCT01984229|Secondary|AUClast of RO5468924: Cohort B|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||h*ng/mL||Standard Deviation|Mean
2617123|NCT01984229|Secondary|Cmax of RO5468924: Cohort B|RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||ng/mL||Standard Deviation|Mean
2617124|NCT01984229|Secondary|AUC0-inf of RO5468924: Cohort A|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort A]. Here, number of participants analyzed = participants who were evaluable for this outcome.|||h*ng/mL||Standard Deviation|Mean
2617125|NCT01984229|Secondary|AUClast of RO5468924: Cohort A|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort A]|||h*ng/mL||Standard Deviation|Mean
2617126|NCT01984229|Secondary|Cmax of RO5468924: Cohort A|RO5468924 is M4 metabolite of Alectinib.|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort A]|||ng/mL||Standard Deviation|Mean
2617127|NCT01984229|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of RO5424802: Cohort B|AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||h*ng/mL||Standard Deviation|Mean
2617128|NCT01984229|Primary|AUClast of Alectinib: Cohort B|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B]|||h*ng/mL||Standard Deviation|Mean
2617129|NCT01984229|Primary|Cmax of Alectinib: Cohort B||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosing|PK Analysis Population [Cohort B] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.|||ng/mL||Standard Deviation|Mean
2617130|NCT01984229|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Alectinib: Cohort A|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|PK Analysis Population [Cohort A]|||hours*nanograms per milliliter (h*ng/mL)||Standard Deviation|Mean
2617131|NCT01984229|Primary|Maximum Observed Plasma Concentration (Cmax) of Alectinib: Cohort A||Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period|Pharmacokinetic (PK) Analysis Population [Cohort A] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2617132|NCT01983969|Primary|Participants With Event-free Survival (EFS)|EFS is defined as the time from transplantation to either relapse, second tumors, or death, whichever occurred first, or last contact. EFS was analzyed by the individual disease groups rather than the cohort dose levels.|Enrollment up to 100 days post transplant.||||Participants|||Count of Participants
2617133|NCT01983969|Primary|Frequency of DLT|Maximum tolerated dose (MTD) of azacitidine based on DLT was defined as any Grade 4 nonhematologic and noninfectious toxicity or any grade 3 mucositis or skin toxicity lasting > 3 days at peak severity. For dose finding, the continunal reassessment method was used with a target DLT probability per cohort of 25%. Azacitidine doses were chosen adaptively for sucessive cohorts with a minimum size of 2 patients. Toxicity scoring followed the National Cancer Institute Common Toxicity Criteria, version 3.|Enrollment up to day 30 post transplant for each dosing cohort||||Dose-limiting toxicities|||Number
2617134|NCT01983930|Secondary|Change in Functional Magnetic Resonance Imaging (fMRI) Connectivity|FMRI scans will be obtained at baseline and after 12 weeks follow up. Default mode network findings were analyzed and significant effects were identified for yoga and memory enhancement training groups.|12 weeks||||p-value|||Number
2617135|NCT01983930|Secondary|Geriatric Depression Scale (GDS)|Secondary outcomes measures included mood assessments with the GDS, a self-assessment scale often used in geriatric depression trials. The GDS is a 30-item screening tool used to identify depression in older adults. In scoring the Geriatric Depression Scale, each item is scored 0 or 1. The total score on the scale ranges from 0 to 30 with higher scores indicating worse outcome.|Baseline and Week 24||||units on a scale||Standard Deviation|Mean
2617136|NCT01983930|Secondary|Clinical Global Impression Scale|The CGI measures severity of illness and global improvement. The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI global improvement scores range from 1 (very much improved) through to 7 (very much worse).|Baseline, weeks 2, 4, 6, 8, 10, 12, 24|Data were not collected.||||||
2617148|NCT01983826|Primary|Change in Functional Capacity - Distance Walked in 6 Minutes|6-minute walk tests will be performed before and after treatment to assess functional capacity. The main comparisons will be changes distance walked in 6 minutes after 8 weeks of dietary nitrate supplementation.|Pre and post 8 weeks of dietary nitrate supplementation||||meters||Standard Deviation|Mean
2617137|NCT01983930|Primary|Cognitive Measures - Hopkins Verbal Learning Test (HVLT) Total Recall Score|Primary outcome measures were administered by a cognitive battery of neuropsychological and included memory and executive functioning. Verbal memory was measured with the Hopkins Verbal Learning Test (HVLT) total recall scores. The HVLT form contains 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. When scoring the HVLT, the three learning trials are combined to calculate a total recall score. Total scores range from 0-36 with higher scores indicating better outcome.|At baseline and at 6 months||||units on a scale||Standard Deviation|Mean
2617138|NCT01983878|Secondary|PK: Area Under the Curve Time Zero to Infinity (AUC[0-∞]) of Ramucirumab||Cycle 1 Day 1: Pre-Dose, End of Infusion: 1, 4, 23, 47, 95, 167, 263, and 335 Hours Post-Dose|PK population: Enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data.|||hours x micrograms/milliliters (h*μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2617139|NCT01983878|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab||Cycle 1 Day 1: Pre-Dose, End of Infusion. 1, 4, 23, 47, 95, 167, 263, and 335 Hours Post-Dose|PK population: enrolled participants who received at least one dose of the study drug and had evaluable ramucirumab PK data.|||micrograms/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2617140|NCT01983878|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|A sample will be considered positive for circulating anti-ramucirumab antibodies if it exhibits a post-baseline antibody level that exceeds the upper 95% confidence interval of the mean determined from the normal anti-ramucirumab level seen in healthy untreated individuals. A participant will be considered to have an anti-ramucirumab response if there are 2 consecutive positive samples or if the final sample tested is positive.|Cycle 1: Pre-infusion, Cycle 2: Pre-infusion, Cycle 3: Pre-infusion, Follow Up|All enrolled participants who received at least one dose of study drug and had evaluable immunogenicity data.|||participants|||Number
2617141|NCT01983878|Secondary|Overall Survival (OS)|The OS time is defined as the time from baseline to the date of death from any cause. If a participant is not known to have died on or before the date of data cut-off, OS data will be censored on the last date (on or before the cut-off date) the participant was known to be alive.|Baseline to Death from Any Cause (Up to 13 Months)|FAS: all enrolled participants who received at least one dose of the study drug. 18 participants were censored.|||Months||90% Confidence Interval|Median
2617142|NCT01983878|Secondary|Percentage of Participants Achieving Stable Disease (SD) or a Confirmed CR or PR [Disease Control Rate (DCR)]|Participants achieved disease control if they had a best overall response of CR, PR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control = (number of participants with CR, PR, or SD)/(number of participants assessed)*100.|Baseline to Measured PD or Death from Any Cause (Up to 12 Months)|FAS: all enrolled participants who received at least one dose of the study drug.|||Percentage of Participants||90% Confidence Interval|Number
2617143|NCT01983878|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]|Participants achieved an objective response if they had a best overall response of CR or PR. According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels [if tumor markers were initially above the upper limit of normal (ULN)]. The percentage of participants who achieved an objective response = (number of participants with CR or PR)/(number of participants assessed)*100.|Baseline to Measured PD or Death from Any Cause (Up to 38.0 Weeks)|FAS: all enrolled participants who received at least one dose of the study drug.|||Percentage of Participants||90% Confidence Interval|Number
2617144|NCT01983878|Secondary|Progression-Free Survival (PFS)|The time from baseline to measured Progressive Disease (PD) as defined by RECIST v.1.1 [defined as > 20% increase from smallest sum of longest diameter recorded since treatment started (best response)], or death due to any cause, whichever is first.|Baseline to Measured PD or Death from Any Cause (Up to 30.3 weeks)|FAS: all enrolled participants who received at least one dose of the study drug. 8 participants were censored.|||Weeks||90% Confidence Interval|Median
2617145|NCT01983878|Primary|Percentage of Participants Who Are Progression-Free at 12 Weeks (Progression-Free Survival [PFS] Rate at 12 Weeks)|The 12-week PFS rate is the probability of participants who survived during the first 12 weeks in the study without disease progression. It was estimated using the Kaplan-Meier method for the main analysis of the 12-week PFS rate.|12 Weeks|Full Analysis Set (FAS): all enrolled participants who received at least one dose of the study drug. 8 participants were censored.|||Percentage of Participants||90% Confidence Interval|Number
2617146|NCT01983839|Primary|Area Under the Free Concentration-time Curve (fAUC0-24)|"The moxifloxacin plasma concentration-time profiles were described with a one compartment model with first-order absorption and elimination rate. The model estimated median values of fAUC0-24 for the current study population were reported.~fAUC0-24 were divided by the ECOFF MIC for S. pneumoniae (0.5 mg/L), H. influenzae (0.125 mg/L) and L. pneumophilia (1.0 mg/L)"|The second day of Moxifloxacin treatment|The model estimated median values of fAUC0-24 for the current study population were32.78 mg.hr/L (IQR 22.75; 47.31). respectively.|||mg.hr/L||Inter-Quartile Range|Median
2617147|NCT01983839|Primary|Total Peak Plasma Concentration (Cmax)|"The moxifloxacin plasma concentration-time profiles were described with a one compartment model with first-order absorption and elimination rate. The model estimated median values of total Cmax for the current study population were reported.~Each individual model predicted Cmax were divided by the ECOFF MIC for S. pneumoniae (0.5 mg/L), H. influenzae (0.125 mg/L) and L. pneumophilia (1.0 mg/L)"|The second day of Moxifloxacin treatment||||mg/L||Inter-Quartile Range|Median
2617149|NCT01983826|Primary|Change in Arterial Stiffness|ECG gated arterial waveforms will be obtained via applanation tonometry from the carotid and femoral arteries. The pulse wave velocity (PWV; index of arterial stiffness) will be determined between the carotid and femoral measurement sites (cfPWV). The time (t) between the feet of recorded pressure waves will be determined as the mean of 10 consecutive cardiac cycles. PWV is calculated from the distance (D; meters) between measurement points and the measured time delay (t): PWV = D/Δt (m/s).|Pre and post 8 weeks of dietary nitrate supplementation|We were only able to obtain quality PWV measures in 11 subjects in the sodium nitrate group and 6 in the placebo group.|||m/sec||Standard Deviation|Mean
2617150|NCT01983826|Primary|Change in Vasodilator Capacity|Forearm and calf blood flow will be measured independently by venous occlusion plethysmography using mercury-in-silastic strain gauges. Plethysmographic measurements will be made at rest and following 5 minutes of ischemia (reactive hyperemia) of the distal limb (forearm and calf). Peak blood flow will be determined as the highest flow recorded during the post deflation period. Total blood flow will be measured as the area under the time-curve after resting flow is subtracted. Vascular conductance will be calculated using blood flow/mean arterial pressure (via finger plethysmograph).|Pre and post 8 weeks of dietary nitrate supplementation|Calf blood flow measures were only performed in 11 of the subjects in the NaNO3 group and 7 of the subjects in the Placebo group.|||ml/100ml tissue/min||Standard Deviation|Mean
2617151|NCT01983787|Secondary|MIC of Pathogen Detected in Sputum Sample, Prior to Initiation of Treatment.|MIC to piperacillin/tazobactam was obtained by using E-tests (AB Biodisk, Solna, Sweden) on Mueller-Hinton agar plates incubated at 35 ± 2 degrees Celcius with inoculum, incubation time and atmosphere in accordance to the E-test application guide.|Sputum sample was collected 3 to 7 days before treatment initiation.||||mg/L|||Number
2617152|NCT01983787|Secondary|The Time Above the Minimum Inhibitory Concentration (T>MIC)|"The time, expressed in percentage, for which the plasma concentration of Piperacillin lies above the minimum inhibitory concentration for the pathogen,during the treatment. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%. MIC for the pathogen in sputum was not reported in patient 5. Therefore,T>MIC for this patient could not be estimated.~Patient 1-5 were treated with piperacillin 16g/day. Patient 6-10 were treated with piperacillin 12g/day."|Patients will be followed for the duration of treatment, which is approximately 2 weeks.||||% of time above the MIC|||Number
2617153|NCT01983787|Primary|Blood-plasma Concentration of Piperacillin|"The free, non-protein bound fraction of plasma piperacillin for each patient was determined using Ultra High Performance Liquid Chromatography. The concentration was compared to the MIC-value (Minimal Inhibitory Concentration) of the pathogen isolated in a sputum sample collected prior to initiation of antibiotic treatment.~Infusion pumps with 16 g of piperacillin per 24 hours were initially used and five patients had piperacillin plasma-concentrations monitored during this treatment regimen. However, in three of these patients, the piperacillin plasma concentrations were unexpectedly low and dropped to a level below the MIC. This was found to be due to antibiotic crystallization within the infusion pumps as a result of the antibiotic concentration being too high. Consequently, infusion pumps with 12 g of piperacillin per 24 hours were used in stead. The median piperaillin concentrations reported below are derived from all measurements within the two weeks of treatment."|Piperacillin plasma-concentration was determined 3-5 times for each patient, during the 2 weeks of piperacillin treatment||||mg/L||Inter-Quartile Range|Median
2617154|NCT01983683|Other Pre-specified|Recurrence Rate|Recurrence is defined as the occurrence of a new episode of diarrhea (> 3 unformed bowel movements on any day between end-of-treatment + 3 days and end-of-treatment + 30 days ) Recurrence rates is the percentage of subjects assessed as having a recurrence out of subjects with Clinical Cure.|Between Day 13 and Day 40 on average (from end-of-treatment + 3 days and end-of-treatment + 30 days)|Subjects from the modified intent-to-treat analysis set (mITT) with clinical cure|||Percentage of participants||95% Confidence Interval|Number
2617155|NCT01983683|Other Pre-specified|Sustained Cure Rate (SCR) in the Per-protocol Population|Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The analyses performed on the modified intent-to- treat set (mITT) are repeated on the per-protocol set (PPS) for sensitivity.|Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)|Per-protocol population: all subjects from the mITT population without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable.|||Percentage of participants||95% Confidence Interval|Number
2617156|NCT01983683|Other Pre-specified|Investigator's Assessment of Sustained Response Rate (ISR Rate) at Visit 5|ISR rate (%) is the percentage of subjects assessed as Sustained Cure at Visit 5, according to the investigator's own judgement. Sustained Cure is defined for each subject having Clinical Cure and no recurrence. Subjects with missing assessment are considered as having 'Not Sustained Cure' for the analysis. ISR rate is used as a supportive measure of the secondary efficacy endpoint (SCR). Analyses are performed on the modified intent-to-treat set (mITT).|Between Day 38 and Day 42 on average (end-of-treatment + 28 to 32 days)|Modified intent-to-treat population (mITT): all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD, and excluding 22 randomized subjects due to potential data integrity issues.|||Percentage of participants||95% Confidence Interval|Number
2617157|NCT01983683|Other Pre-specified|Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Per-protocol Population|ICR rate (%) is the percentage of subjects with clinical response assessed as cured according to the investigator's own judgement. ICR rate (%) is the percentage of subjects with ICR assessed as cured. Subjects with missing assessment are considered as not cured for the analysis. ICR rate is used as a supportive measure of the primary efficacy endpoint (CCR). Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below.|Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)|Per-protocol population: all subjects from the mITT analysis set without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable.|||Percentage of participants||95% Confidence Interval|Number
2617178|NCT01983553|Primary|Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23)|Episodes were defined as the number of hospitalized VCD episodes.|Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23|Analysis was performed on FupAS.|||Episodes|||Number
2617158|NCT01983683|Other Pre-specified|Investigator's Assessment of Clinical Response (ICR) Rate at Visit 4 in the Modified Intent-to-treat Population|ICR rate (%) is the percentage of subjects with clinical response assessed as cured according to the investigator's own judgement. Subjects with missing assessment are considered as not cured for the analysis. ICR rate is used as a supportive measure of the primary efficacy endpoint (CCR). Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below.|Up to Day 12 on average (up to end-of-treatment + 2 to 4 days)|Modified intent-to-treat population: all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD, and excluding 22 randomized subjects due to potential data integrity issues.|||Percentage of participants||95% Confidence Interval|Number
2617159|NCT01983683|Secondary|Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores|CDI-DaySyms PRO is a questionnaire assessing 10 symptoms relevant to subjects with CDAD and grouped into 3 domains: Diarrhea symptoms, Abdominal symptoms and Systemic/Other. The subjects rate the severity of each item as None, Mild, Moderate, Severe or Very severe, converted to numeric scores from 0 to 4, respectively. The daily domain score is calculated as the mean of the non-missing responses for that domain on that day. A negative value for change from baseline corresponds to an improvement in domain score. The three domains are evaluated in a hierarchical manner, starting with Diarrhea Symptoms, then Abdominal Symptoms, and finally Systemic/Other Symptoms.|Baseline to End of Treatment (10 days after starting study drug) + 2 days|All subjects from the modified intent-to-treat population, excluding those who participated in the validation sub-study. No imputation of missing scores is performed prior to deriving response status. Subjects with missing values at baseline or at Day 3 are considered to be non-responders.|||Scores on a scale||95% Confidence Interval|Number
2617160|NCT01983683|Secondary|Kaplan-Meier Estimates for Resolution of Diarrhea (ROD)|"Resolution of Diarrhea (ROD) is defined as no more than 3 unformed bowel movements per day for at least two consecutive days for subjects on study treatment.~The Kaplan-Meier estimates (KM estimates) for having an event (ROD) are reported for each time point."|Up to Day 10|Modified intent-to-treat population (mITT): all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD, and excluding 22 randomized subjects due to potential data integrity issues.|||KM estimate (% subjects with ROD)||95% Confidence Interval|Number
2617161|NCT01983683|Secondary|Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population|Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The main analysis is performed on the modified intent-to-treat set (mITT).|Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)|Modified intent-to-treat population (mITT): all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD, and excluding 22 randomized subjects due to potential data integrity issues.|||Percentage of subjects||95% Confidence Interval|Number
2617162|NCT01983683|Primary|Clinical Cure Rate (CCR) in the Per-protocol Population|Clinical Cure (CC) is defined as: • Resolution of Diarrhea (≤ 3 unformed bowel movement per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant between first dose of study drug and 2 days after EOT. CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below.|Up to Day 12 on average (end-of-treatment + 2 days)|per-protocol population: all subjects from the mITT population without protocol deviations that might affect the evaluation of the effect of the study drug on the primary variable.|||Percentage of participants||95% Confidence Interval|Number
2617163|NCT01983683|Primary|Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population|Clinical Cure is defined as: • Resolution of Diarrhea (ROD) (≤ 3 unformed bowel movement (UBM) per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant (FMT) between first dose of study drug and 2 days after EOT (inclusive). CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below.|Up to Day 12 on average (end-of-treatment + 2 days)|Modified intent-to-treat population (mITT): all subjects who received at least one dose of study drug and had a confirmed diagnosis of CDAD, and excluding 22 randomized subjects due to potential data integrity issues.|||Percentage of participants||95% Confidence Interval|Number
2617164|NCT01983566|Secondary|AUC(0-inf)|Area under the concentration-time curve of deleobuvir in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)|1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration|PKS - Due to premature discontinuation of the study, this endpoint was not evaluated.||||||
2617165|NCT01983566|Primary|Cmax|Maximum measured concentration of deleobuvir in plasma (Cmax)|1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration|PKS|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2617166|NCT01983566|Primary|AUC(0-tz)|Area under the concentration-time curve of deleobuvir in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)|1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration|Pharmacokinetic set (PKS): included all subjects in the Treated Set who provided at least 1 observation for at least 1 primary pharmacokinetic (PK) endpoint that was not affected by important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2617177|NCT01983553|Primary|Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)|Event rate per 100 participant-years for hospitalized VCD cases, due to any and each serotype (1, 2, 3 and 4) following vaccination with either CYD Dengue vaccine or Placebo in the previous study (CYD23) were reported. Endpoint values <0.1 were rounded to 0.1.|Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23|"Analysis was performed on FupAS. Here, number analyzed signifies participants with available data for each specified category."|||Events per 100 participant-years||95% Confidence Interval|Number
2617167|NCT01983553|Primary|Number of Episodes of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)|Episodes were defined as the number of hospitalized virologically confirmed dengue episodes meeting WHO criteria. The WHO criteria was fever, any haemorrhagic manifestations, thrombocytopenia, plasma leakage or pleural effusion and/or ascites and/or hypoalbuminemia. Dengue haemorrhagic fever was graded as Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test. Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhages. Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness. Grade IV: Profound shock with undetectable blood pressure and pulse.|Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23|Analysis was performed on FupAS.|||Episodes|||Number
2617168|NCT01983553|Primary|Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) and Meeting WHO 1997 Criteria Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)|Cases were defined as the number of participants with at least one hospitalized VCD episode meeting WHO criteria. The WHO criteria was fever, any haemorrhagic manifestations, thrombocytopenia, plasma leakage or pleural effusion and/or ascites and/or hypoalbuminemia. Dengue hemorrhagic fever was graded as - Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation was a positive tourniquet test. Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhages. Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness. Grade IV: Profound shock with undetectable blood pressure and pulse.|Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23|Analysis was performed on FupAS.|||Cases|||Number
2617169|NCT01983553|Primary|Event Rate Per 100 Participant-years for Hospitalized VCD Cases Due to Any and Each Serotype and Meeting World Health Organization (WHO) 1997 Criteria Collected Following Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)|Event rate per 100 participant-years for hospitalized VCD cases, due to any and each serotype (1, 2, 3 and 4) following vaccination with either CYD Dengue vaccine or Placebo in the previous study (CYD23) were reported. Endpoint values <0.1 were rounded to 0.1. The WHO criteria were fever, any haemorrhagic manifestations, thrombocytopenia, plasma leakage or pleural effusion and/or ascites and/or hypoalbuminemia. Dengue haemorrhagic fever was graded as Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test. Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhages. Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness. Grade IV: Profound shock with undetectable blood pressure and pulse.|Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23|Analysis was performed on FupAS.|||Events per 100 participant-years||95% Confidence Interval|Number
2617170|NCT01983553|Primary|Non-Serotype Specific Dengue Viremia Among Hospitalized VCD Cases Following Vaccination With CYD Dengue Vaccine or Placebo in Previous Study (CYD23)|Quantified viremia was defined as greater than or equal to (>=) lower limit of quantitation (log10 plaque forming unit [pfu]/mL).|Year 1 to Year 4 post-vaccination after 3rd vaccination at Month 12 in CYD23 at each of the following time points: Anytime, 0-3 days, 4-7 days, 0-7 days, After 7 days during the sample collection time interval of 14 days|Analysis was performed on FupAS. Here, 'number analyzed' = number of hospitalized VCD episodes in the specified time period.|||log10 pfu/mL||Standard Deviation|Mean
2617171|NCT01983553|Primary|Number of Cases of Non-Serotype Specific Dengue Viremia Among Hospitalized VCD Cases Following Vaccination With CYD Dengue Vaccine or Placebo in Previous Study (CYD23)|Cases were defined as the number of participants with at least one non-serotype specific dengue viremia among hospitalized VCD cases.|During Year 1 to Year 4 post 3rd vaccination at Month 12 in CYD23 at each of the following time points: Anytime, 0-3 days, 4-7 days, 0-7 days, After 7 days during the sera sample collection time interval of 14 days|Analysis was performed on FupAS. Here, 'number analyzed' = number of hospitalized VCD episodes in the specified time period.|||Participants|||Number
2617172|NCT01983553|Primary|Number of Episodes of Clinically Severe Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)|Episodes were defined as the number of hospitalized VCD episodes.|Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23|Analysis was performed on FupAS.|||Episodes|||Number
2617173|NCT01983553|Primary|Number of Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)|Cases were defined as the number of participants with at least one hospitalized VCD episode.|Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23|Analysis was performed on FupAS.|||Cases|||Number
2617174|NCT01983553|Primary|Event Rate Per 100 Participant-years for Clinically Severe Hospitalized VCD Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)|Event rate per 100 participant-years for Clinically Severe hospitalized VCD cases, due to any and each serotype (1, 2, 3 and 4) following vaccination with either CYD Dengue vaccine or Placebo in the previous study (CYD23) were reported. Endpoint values <0.1 were rounded to 0.1.|Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23|Analysis was performed on FupAS.|||Events per 100 participant-years||95% Confidence Interval|Number
2617175|NCT01983553|Primary|Number of Episodes of Hospitalized VCD Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)|Episodes were defined as the number of hospitalized VCD episodes.|Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23|Analysis was performed on FupAS. Here, “number analyzed” signifies participants with evaluable data for each specified category.|||Episodes|||Number
2617176|NCT01983553|Primary|Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Collected By Age Group (Aged: 4-5; 6-11 Years) Following Vaccination With Either CYD Dengue Vaccine or Placebo in a Previous Study (CYD23)|Cases were defined as the number of participants with at least one hospitalized VCD episode.|Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23|Analysis was performed on FupAS. Here, “number analyzed” signifies participants with evaluable data for each specified category.|||Cases|||Number
2617179|NCT01983553|Primary|Number of Hospitalized VCD Cases Due to Any and Each Serotype (1, 2, 3 and 4) Following Vaccination With Either CYD Dengue Vaccine or a Placebo in a Previous Study (CYD23)|Cases were defined as the number of participants with at least one hospitalized VCD episode.|Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23|Analysis was performed on FupAS.|||Cases|||Number
2617180|NCT01983553|Primary|Event Rate Per 100 Participant-years for Hospitalized Virologically-Confirmed Dengue (VCD) Cases Due to Any and Each Serotype Following Vaccination With Either CYD Dengue Vaccine or Placebo in the Previous Study (CYD23)|Event rate per 100 participant-years for hospitalized VCD cases, due to any and each serotype (1, 2, 3 and 4) following vaccination with either CYD Dengue vaccine or Placebo in the previous study (CYD23) were reported.|Year 1 to Year 4 post- 3rd vaccination at Month 12 in CYD23|Analysis was performed on FupAS.|||Events per 100 participant-years||95% Confidence Interval|Number
2617181|NCT01983293|Primary|Number of Patients With Improved Clinical Composite Score|"Evaluate the Clinical Composite Score (CCS) at 12 months in NLBBB patients using a standard of care vs. latest electrical delay (QLV) implant strategy. The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are markedly worse, moderately worse, slightly worse, no change, slightly better, moderately better, markedly better. CCS components were used to classify or score subjects as IMPROVED (at least one-class improvement in NYHA Class or improvement by PGA moderately or markedly better AND no HF events AND no cardiovascular death), or WORSENED (worsening in NYHA Class OR worsening by PGA moderately or markedly worse OR presence of HF events OR Cardiovascular death, or UNCHANGED (neither improved or worsened). Note CCS is not a numeric score."|12 months|Of the 242 subjects enrolled, 44 withdrew for reasons other than cardiac death, six had a missing 12-month visit for reasons other than a heart failure event and two had missing Patient Global Assessments or NYHA classification assessments. As a result, the primary endpoint analysis included 190 enrolled subjects (128 QLV arm; 62 control arm).|||Participants|||Count of Participants
2617182|NCT01983254|Other Pre-specified|Total Weeks at Home Post-randomization|here reported as weeks (instead of days) not at home for simplicity|over 6 months follow up|patients|||weeks not at home during follow up|weeks|Standard Deviation|Mean
2617183|NCT01983254|Secondary|Impact of Events Scale-revised (IES-R) Score|"The IES-R evaluates subjective distress caused by traumatic events and assesses manifestations of post-traumatic stress disorder (PTSD) or acute stress disorder. It is not diagnostic but possesses excellent reliability and validity for manifestations of PTSD. The IES-R has three subscales (eight items on intrusion, eight items on avoidance, and six items on hyperarousal). Each item is scored on a four point scale: 0 = not at all, 1 = a little bit, 2 = moderately often, 3 = quite a bit, and 4 = extremely often. The total score of each subscale may be averaged and a cumulative score of 30 is indicative of the presence of PTSD. The maximum score for each subscale is 32 for intrusion, 32 for avoidance, and 24 for hyperarousal. The minimum cumulative score is 0 and the maximum cumulative score possible is 88.3 months post-randomization is main time point while The 3 month IES-R score will be the primary analysis, though 6 month changes will be tested as well."|3 & 6 months post-randomization|Patients who completed the IES-R scale at 3 & 6 months post-randomization.|||units on a scale (IES-R)||Standard Error|Mean
2617184|NCT01983254|Primary|Hospital Anxiety and Depression Scale Score|Hospital Anxiety and Depression Scale (HADS) questionnaire: The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale. The 3 month measure is primary outcome timing, though changes at 6 months will be tested as well|3 & 6 months post-randomization|Patients who completed the HADS scale at 3 & 6 months post-randomization.|||units on a scale (HADS summary score)||Standard Error|Mean
2617185|NCT01983111|Secondary|Patient Global Impressions of Change(PGIC)|"In the PP set, Number of participants with categorical change in overall satisfaction.~PGIC: a participant-rated instrument assessing change in participant's overall satisfaction from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse)."|6 weeks|Per protocol set: Analyze the within-group change in the PGIC from Baseline (Week 0) to Week 6 by using a paired t-test, and analyze the between-group difference in the change of satisfaction by using a t-test.|||Scores on 1 to 7point||Standard Deviation|Mean
2617186|NCT01983111|Secondary|Clinical Global Impression of Change(CGIC)|The number of patients who choose the best opinion of overall satisfaction among Clinical Global Impression of Change Scale(CGIC) among 7 point scale. Missing data was imputed by LOCF. Scores measure from 1: Very much improved to 7:very much worse.|6 weeks|In the per protocol: Analyze the within-group change in the CGIC from Baseline (Week 0) to Week 6 of the investigational product administration by using a paired t-test, and analyze the between-group difference in the change of satisfaction by using a t-test.|||Scores on 1 to 7 point||Standard Deviation|Mean
2617187|NCT01983111|Secondary|Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)|The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' (score = 100) and 'Worst imaginable health state' (score = 0). Higher points were positive results and positive points of difference gap means improvement results.|Baseline and at 6weeks|In the PP set, the change in the your today health score from Visit 1 (Baseline) to Week 6 of the investigational product administration was analyzed.|||scores on a scale||Standard Deviation|Mean
2617188|NCT01983111|Secondary|Change in the Quality of Life (EQ-5D) Score From Visit 1 (Baseline) to Week 6 Post-dose|"EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions for 'Motor capability', 'Self-care', 'Daily activities', 'Pain/discomfort', 'Depression/anxiety' and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)).~*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)~EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by 1 means that the healthy condition and high quality of life."|Baseline and at 6 weeks|In the PP set, the change in the quality of life (EQ-5D) total score from Visit 1 (Baseline) to Week 6 of the investigational product administration was analyzed.|||EQ-5D Total score||Standard Deviation|Mean
2617189|NCT01983111|Secondary|Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to Week 2 of the Investigational Product Administration|NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week 2/ET minus mean score at Baseline.|2 weeks|In the PP set, the reduction in the pain intensity score from Visit 1 (Baseline) to Week 2 of the investigational product administration was analyzed.|||Scores on a scale||Standard Deviation|Mean
2617190|NCT01983111|Primary|Change in the Pain Intensity Score (0-10 NRS) From Visit 1 (Baseline) to 6weeks After Treatment.|NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week6/ET minus mean score at Baseline.|baseline and 6 weeks|In the PP set, the change in the pain intensity score from Visit 1 (Baseline) to Week 6 of the investigational product administration was analyzed.|||Scores on a scale||Standard Deviation|Mean
2617191|NCT01983020|Primary|Pain Intensity|The primary outcome will be average pain intensity at rest on postoperative day 1 - 3. Pain Intensity rated from 0 (none) to 10 (severe).|postoperative day 1 - 3||||units on a scale||Standard Deviation|Mean
2617192|NCT01982812|Secondary|Sequelae|"Neurologic outcome in 3 categories--~Neurologically intact at discharge~Neurologic sequelae at discharge--specifically new sensory or motor deficits, ongoing seizures, or behavioral abnormalities based upon a physician examination at discharge~Died during admission, never discharged"|7 days||||participants|||Number
2617193|NCT01982812|Secondary|Mean Time From Admission to BCS >/= 4|"The mean time in hours from admission until the subject reaches Blantyre Coma Scale of greater than or equal to 4. Participants who died are excluded from this analysis.~The Blantyre Coma Score has ranges from 0-5 based upon the a sum of the following 3 domains- Eye movement~1 - Watches or follows 0 - Fails to watch or follow~Best motor response 2 - Localizes painful stimulus 1 - Withdraws limb from painful stimulus 0 - No response or inappropriate response~Best verbal response 2 - Cries appropriately with pain, or, if verbal, speaks~1 - Moan or abnormal cry with pain 0 - No vocal response to pain"|7 days|Comparing mean time to coma resolution in hours among survivors|||hours of coma from admission||Standard Deviation|Mean
2617194|NCT01982812|Secondary|Required Additional AED|Additional AEDs required (including for breakthrough seizures in LVT group) during admission for seizure control (yes/no)|7 days||||Participants requiring additional AEDs|||Number
2617195|NCT01982812|Primary|Minutes With Seizure on EEG|Comparing LVT to standard AED the number of minutes spent in seizure per cEEG in the 72 hours after treatment allocation.|72 hours||||minutes with seizure||Standard Deviation|Mean
2617196|NCT01982773|Primary|Beck Scale for Suicidal Ideation|measures self-report severity of suicidal ideation during the past week using 21 items. Three factors are assessed: desire for death, preparation for suicide and actual suicide desire. This measure assess an individual's thoughts, attitudes and intentions regarding suicide. Scores could range from 0 - 48.The higher the score indicated the greater risk for suicidal ideation.|12 week follow up||||units on a scale||Standard Deviation|Mean
2617197|NCT01982773|Primary|Beck Scale for Suicidal Ideation|measures self-report severity of suicidal ideation during the past week using 21 items. Three factors are assessed: desire for death, preparation for suicide and actual suicide desire. This measure assess an individual's thoughts, attitudes and intentions regarding suicide. Scores could range from 0 - 48.The higher the score indicated the greater risk for suicidal ideation.|6 week follow up||||units on a scale||Standard Deviation|Mean
2617198|NCT01982773|Primary|Beck Scale for Suicidal Ideation|measures self-report severity of suicidal ideation during the past week using 21 items. Three factors are assessed: desire for death, preparation for suicide and actual suicide desire. This measure assess an individual's thoughts, attitudes and intentions regarding suicide. Scores could range from 0 - 48.The higher the score indicated the greater risk for suicidal ideation.|3 week follow up||||units on a scale||Standard Deviation|Mean
2617199|NCT01982773|Primary|Beck Scale for Suicidal Ideation|measures self-report severity of suicidal ideation during the past week using 21 items. Three factors are assessed: desire for death, preparation for suicide and actual suicide desire. This measure assess an individual's thoughts, attitudes and intentions regarding suicide. Scores could range from 0 - 48. The higher the score indicated the greater risk for suicidal ideation.|Baseline||||units on a scale||Standard Deviation|Mean
2617200|NCT01982695|Primary|Cardiac Ejection Fraction as Measured by Echocardiogram|Mean cardiac ejection fraction as measured by echocardiogram at 12 month study visit. Cardiac ejection fractions were measured using the biplane Simpson's rule using images obtained from the apical 4 chamber views of the heart.|12 month visit|All patients that received a 12 month echocardiogram evaluation|||percentage of blood leaving the heart||Standard Deviation|Mean
2617201|NCT01982682|Secondary|Median Pace of T Cell Immune Recovery at 90 Days Post Hematopoietic Stem Cell Transplantation (HSCT)|An excess amount of residual T-lymphocytes in the Peripheral Blood Stem Cell Collection (PBSC) product may increase the risk of GVHD. The ideal amount of T-cells left in the PBSC product is no greater than 5x104/kg. Every effort will be made to keep T-cell amounts to below this threshold. The median pace of T-cell immune recovery at 90 days will be monitored by collecting cluster of differentiation (CD24) and (CD38).|90 days post HSCT|5 subjects were not evaluable for this outcome measure.|||cells/ul||Full Range|Median
2617202|NCT01982682|Secondary|Median Pace of T Cell Immune Recovery at 28 Days Post Hematopoietic Stem Cell Transplantation (HSCT)|An excess amount of residual T-lymphocytes in the Peripheral Blood Stem Cell Collection (PBSC) product may increase the risk of GVHD. The ideal amount of T-cells left in the PBSC product is no greater than 5x104/kg. Every effort will be made to keep T-cell amounts to below this threshold. The median pace of T-cell immune recovery at 28 days will be monitored by collecting cluster of differentiation (CD24) and (CD38).|At 28 days post HSCT|3 subjects were not evaluable for this outcome measure.|||cells/ul||Full Range|Median
2617221|NCT01982435|Primary|Number of Participants With Non-severe Ocular Adverse Events|As identified by eye examination (including visual acuity testing), identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.|12 months|Patients who exited the study early were accounted by using a last observation carried forward approach.|||Participants|||Count of Participants
2620702|NCT01953328|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2617203|NCT01982682|Secondary|Count of Participants That Experienced Death as a Result of Graft-versus-host Disease (GVHD)|"Graft versus host disease was clinically characterized based on 4 stages of progression for three major body areas, skin, liver, gut. Subjects who experienced life threatening reactions in their skin, liver and gut ultimately experienced functional impairment and expired.~Life threatening reactions in the Skin were characterized by desquamation (the shedding of the outer layers of skin) and bullae (a bubblelike cavity filled with air or fluid, in particular).~Life threatening reactions in the Liver were characterized by Bilirubin, > 15 mg/dl Life threatening reactions in the Gut were characterized by Pain +/- ileus (a painful obstruction of the ileum or other part of the intestine.)"|Up to 1 year after HSCT||||Participants|||Count of Participants
2617204|NCT01982682|Secondary|Number of Participants With Successful Engraftment|Will be reported descriptively. Successful engraftment is defined as ANC (absolute neutrophil count, the number of white blood cells (WBCs) that are neutrophils) ≥ 0.5x109/L for at least 30 days and Platelet engraftment > 20,000 with no transfusion x 7 days.|Up to 1 year after HSCT|One subject was inevaluable|||Participants|||Count of Participants
2617205|NCT01982682|Primary|Count of Participants That Experience 1 Year Relapse Free Survival After Undergoing Hematopoietic Stem Cell Transplantation (HSCT) Using the Thomas Jefferson University 2 Step Approach||Up to 1 year after HSCT|One subject was inevaluable.|||Participants|||Count of Participants
2617206|NCT01982643|Primary|"Participants Categorized as Responders"|"Study Responders were defined as participants providing six MA-negative urine tests of eight administered in the evaluation period (the last four weeks of the active medication phase), including the last test collected in the final study week of the active medication phase."|Weeks 4-8||||Participants|||Count of Participants
2617207|NCT01982539|Secondary|Percentage Difference of Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration.|Numeric Pain Rating Scale (NPRS) measures the subject intensity of pain on an 11-point scale. 0 = No Pain, 10 = Worst Pain at baseline to (1) the first hour and (2) the second hour after the first dose of Zipsor® administration.|From Baseline to 1st and 2nd hour|Full Analysis Set are enrolled patients who had available valid NPRS scores recorded on Day 1, received at least 1 dose of Zipsor, and completed at least 1 postbaseline NPRS score with a valid score. The Full Analysis Set was the primary population for the efficacy analysis. Safety Analysis Set has n=25.|||percentage difference of NPRS Score||Standard Deviation|Mean
2617208|NCT01982539|Secondary|Changes in the Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration.|Numeric Pain Rating Scale (NPRS) measures the subject intensity of pain on an 11-point scale. 0 = No Pain, 10 = Worst Pain at baseline to (1) the first hour and (2) the second hour after the first dose of Zipsor® administration.|From Baseline to 1st and 2nd hour|Full Analysis Set are enrolled patients who had available valid NPRS scores recorded on Day 1, received at least 1 dose of Zipsor, and completed at least 1 postbaseline NPRS score with a valid score. The Full Analysis Set was the primary population for the efficacy analysis. Safety Analysis Set has n=25.|||score on a scale||Standard Deviation|Mean
2617209|NCT01982539|Primary|Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years|"Safety Endpoints:~Treatment emergent AEs (TEAEs)~Serious adverse events (SAEs)~Withdrawals due to AEs~Deaths~Observed values and changes in vital sign measurements~Observed values and changes in clinical laboratory results~Physical examination findings"|First dose to 30 days after the last dose|The Safety population included all subjects who received at least 1 dose of the study drug.|||participants|||Number
2617210|NCT01982435|Secondary|Number of Participants With Nonperfusion|Number of participants with peripheral nonperfusion in their study eye from baseline to months 3, 6, and 12 (i.e. presence of ischemia).|3, 6 and 12 months||||Participants|||Count of Participants
2617211|NCT01982435|Secondary|Number of Participants With Angiographic Leakage|Number of participants with angiographic leakage in their study eye measured from baseline to months 3, 6 and 12 (i.e. presence of leakage).|3, 6 and 12 months||||Participants|||Count of Participants
2617212|NCT01982435|Secondary|Participants With BCVA at 20/40 or Better|Number of participants with 20/40 or better best-corrected visual acuity in their study eye at months 6 and 12.|Months 6 and 12||||Participants|||Count of Participants
2617213|NCT01982435|Secondary|Loss in Vision Greater Than or Equal to 15 Letters|Number of participants that lost greater than or equal to 15 letters of vision in their study eye at months 6 and 12.|Months 6 and 12||||Participants|||Count of Participants
2617214|NCT01982435|Secondary|Gain in Vision Greater Than or Equal to 15 Letters|Number of participants that gained greater than or equal to 15 letters of vision in their study eye at months 6 and 12.|Months 6 and 12||||Participants|||Count of Participants
2617215|NCT01982435|Secondary|Anatomically Dry Eyes by SDOCT|"Number of participants with an anatomically dry study eye by SDOCT at months 6 and 12"|Months 6 and 12||||Participants|||Count of Participants
2617216|NCT01982435|Secondary|Mean Change in Central Foveal Thickness|Mean absolute change from baseline central foveal thickness at months 6 and 12 as measured by SDOCT (defined as the average thickness within the central 1 mm subfield)|Months 6 and 12||||microns||Standard Deviation|Mean
2617217|NCT01982435|Secondary|Mean Change in BCVA|Mean change in best-corrected visual acuity as assessed by the number of letters read correctly on the electronic ETDRS eye chart from baseline to months 6 and 12.|Months 6 and 12||||ETDRS letters||Standard Deviation|Mean
2617218|NCT01982435|Primary|Number of Participants With Severe Non-ocular Adverse Event|As identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.|12 months||||Participants|||Count of Participants
2617219|NCT01982435|Primary|Number of Participants With Non-severe Non-ocular Adverse Event|As identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.|12 months||||Participants|||Count of Participants
2617220|NCT01982435|Primary|Number of Participants With Severe Ocular Adverse Events|As identified by eye examination (including visual acuity testing), identified by physical examination, subject reporting, and changes in vital signs.|12 months||||Participants|||Count of Participants
2617222|NCT01982383|Primary|Resolution of Fluid Build-up|Central Serous Choroidopathy is a disease that causes fluid to build up under the retina,the back part of the inner eye that sends sight information to the brain. The objective here is to apply 577nm of micropulse laser to see if CSC resolution occurs and measuring it through ocular coherence tomography (retinal imaging), vision score, and visual field testing for retinal sensitivity.|within 1 week to 3 months after the laser procedure is completed|No data analyzed. Study terminated due to lack of enrollment||||||
2617223|NCT01982331|Secondary|Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab|Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.|Days 1-6 and Days 29-34||||Participants|||Count of Participants
2617224|NCT01982331|Secondary|Percentage of Subjects Shedding Influenza A Virus Using Throat Swab|Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.|Days 0-6 and Days 28-34||||Participants|||Count of Participants
2617225|NCT01982331|Secondary|Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab|Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.|Days 0-6 and Days 28-34||||Participants|||Count of Participants
2617226|NCT01982331|Secondary|Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab|Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.|Days 0-6 and Days 28-34||||Participants|||Count of Participants
2617227|NCT01982331|Secondary|Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies Detected in Saliva Specimens|Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination.|Day 28 and Day 56|Subjects that received each vaccination (vaccination 1 for day 28, vaccination 2 for days 56 and 112), did not withdraw from the study, and that had viable immunologic data.|||Participants|||Count of Participants
2617228|NCT01982331|Secondary|Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa|Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination.|Day 28 and Day 56|Subjects that received each vaccination (vaccination 1 for day 28, vaccination 2 for days 56 and 112), did not withdraw from the study, and that had viable immunologic data.|||Participants|||Count of Participants
2617229|NCT01982331|Secondary|Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies|Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days. Measured by enzyme-linked immunosorbent assay (ELISA).|Day 28, Day 56 and Day 112|Subjects that received each vaccination (vaccination 1 for day 28, vaccination 2 for days 56 and 112), did not withdraw from the study, and that had viable immunologic data.|||Participants|||Count of Participants
2617230|NCT01982331|Secondary|Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies|Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days. Measured by enzyme-linked immunosorbent assay (ELISA).|Day 28, Day 56 and Day 112|Subjects that received each vaccination (vaccination 1 for day 28, vaccination 2 for days 56 and 112), did not withdraw from the study, and that had viable immunologic data.|||Participants|||Count of Participants
2617231|NCT01982331|Secondary|Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies|Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days. Measured by microneutralization assay.|Day 28, Day 56 and Day 112|Subjects that received each vaccination (vaccination 1 for day 28, vaccination 2 for days 56 and 112), did not withdraw from the study, and that had viable immunologic data.|||Participants|||Count of Participants
2617232|NCT01982331|Secondary|Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies|Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days.|Day 28, Day 56 and Day 112|Subjects that received each vaccination (vaccination 1 for day 28, vaccination 2 for days 56 and 112), did not withdraw from the study, and that had viable immunologic data.|||Participants|||Count of Participants
2617233|NCT01982331|Primary|Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2|All other adverse events (including unsolicited events and abnormal laboratory parameters) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff.|7 days following each vaccination||||Participants|||Count of Participants
2617234|NCT01982331|Primary|Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1|All other adverse events (including unsolicited events and abnormal laboratory parameters) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff.|7 days following each vaccination||||Participants|||Count of Participants
2617235|NCT01982331|Primary|Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2|Adverse events commonly associated with intranasal vaccination occurring greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. Solicited local reactions included: dryness of the nose, nose bleeds, ticklish nose, nasal congestion, runny nose, ticklish throat, catarrhal nasopharynx. Solicited systemic reactions included: body temperature, feverishness/subjective fever, chills, cough, difficulty breathing, sore throat, headache, confusion, convulsions/seizures, fatigue/malaise, joint aches, muscle aches, pink or red eyes, draining eyes, swollen eyelids, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting.|7 days||||Participants|||Count of Participants
2617236|NCT01982331|Primary|Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1|Adverse events commonly associated with intranasal vaccination occurring greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. Solicited local reactions included: dryness of the nose, nose bleeds, ticklish nose, nasal congestion, runny nose, ticklish throat, catarrhal nasopharynx. Solicited systemic reactions included: body temperature, feverishness/subjective fever, chills, cough, difficulty breathing, sore throat, headache, confusion, convulsions/seizures, fatigue/malaise, joint aches, muscle aches, pink or red eyes, draining eyes, swollen eyelids, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting.|7 days||||Participants|||Count of Participants
2617238|NCT01982292|Secondary|Pharmacokinetics of RLX030: Clearance of Serelaxin (CL)|Clearance (CL) was calculated using concentration at steady state (Css) and the actual delivered dose rate. n: Number of patients with valid PK parameters available within 48 hours post each infusion.|48 hours post each infusion|PK analysis set (PK) - All patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||mL/hr/kg||Standard Deviation|Mean
2617239|NCT01982292|Secondary|Pharmacokinetics of RLX030: Cmax Steady State (Cmaxss) Concentration at 48 Hours|This analysis was not done due to sparse PK sampling.|48 hours post each infusion|Due to sparse PK sampling, this analysis was not done.||||||
2617240|NCT01982292|Secondary|Pharmacokinetics of RLXL030: Actual Concentrations at Steady State (Css)|Concentration at steady state (Css) was estimated using C48 or C24 for patients who received the intended rate of infusion for at least 24hours. n: Number of patients with valid PK parameters available|pre-infusion and 24, 48 hours post each infusion|PK analysis set (PK) - All patients with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data.|||ng/ml||Standard Deviation|Mean
2617241|NCT01982292|Secondary|Pharmacokinetics of RLX030: Area Under the Plasma Concentration Time Curve From Time Zero up to 48 Hours Post Dose (AUC 0-48)|Due to sparse PK sampling, AUC 0-48 hours was not analyzed.|pre-infusion and 8, 24 and 48 hours post each infusion.|Due to sparse PK sampling, this analysis was not done.||||||
2617242|NCT01982292|Secondary|Number of Participants With Adverse Events Such as Adjudicated Potential Hypersensitivity or Infusion Reactions|Incidence rate of special interest, indicative of hypersensitivity reactions which occur during and after administration of repeated infusions of serelaxin relative to placebo in subjects with chronic heart failure is reported. Hypersensitivity reactions or infusion reactions can be headache, nausea, fever, chills, dizziness, flush, pruritus, chest and/or back pain.|16 weeks|Safety set (SAF) - All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment.|||Participants|||Number
2617243|NCT01982292|Secondary|Percentage of Participants With Chronic Heart Failure With Positive Antibody Status Who Develop Non-neutralizing Anti-serelaxin Antibodies Following 3 Repeated Infusions (i.e. at Week 4, Week 8, and Week 12)|"A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive.~n = the total number of subjects with evaluable antibody status after specified number of infusions"|At Week 4, Week 8, Week 12|All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment|||Percentage of participants||90% Confidence Interval|Number
2617244|NCT01982292|Secondary|Antibody Titers in Participants With Chronic Heart Failure Who Develop Positive Anti-serelaxin Antibodies (Neutralizing, Non-neutralizing or Both) at Any Time Following 3 Repeated Infusions and at Week 4, Week 8 and Week 12||Week 4, Week 8, Week 12|Safety set:All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment|||In international Units||Standard Deviation|Mean
2617245|NCT01982292|Secondary|Percentage of Participants With Chronic Heart Failure Who Develop Positive Anti-serelaxin Antibodies After a Single Infusion of Serelaxin Over Time up to Week 16|A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive. Each time period is defined as the time frame from study drug initiation (or the visit if there is no infusion) to prior to study drug initiation of the next period (or the visit if no there is no infusion). n= The total number of subjects with evaluable antibody status during the defined period.|Randomization to Week 4, Week 4 to Week 8, Week 8 to Week 12, week 12 to week 16|All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment.|||Percentage of patients||90% Confidence Interval|Number
2617246|NCT01982292|Primary|Percentage of Participants With Chronic Heart Failure (CHF) Who Develop Anti-serelaxin Antibodies at Any Time Following Repeat Administration of IV Continuous Infusions of Serelaxin Administered for up to 48 Hours in 16 Weeks|"A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive.~A patient is considered antibody negative during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were negative. A patient's antibody status is considered to be undetermined during the study if it is not defined as positive or negative."|16 weeks|Safety Set: All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment. In this reported analysis, patients with undetermined antibody status are excluded from analysis population|||Percentage of participants||90% Confidence Interval|Number
2617247|NCT01982253|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12|The change between the FPG value collected at week 12 or final visit relative to baseline.|Baseline and Week 12|In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.||||||
2617248|NCT01982253|Primary|Change From Baseline in HbA1c at Week 12.|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit relative to baseline.|Baseline and Week 12|In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.||||||
2617249|NCT01982240|Secondary|Change From Baseline in Straining Score Over 12-Week Treatment Period, Mean Replacement Approach|Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly average straining score was derived from the straining scores reported during the Treatment Period in the Daily Symptom Diary. The severity of straining during bowel movements was assessed on a 5-point Likert scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.|12-Week Treatment Period|The ITT (Intent-to-treat) population was used for analysis.|||score on a scale||Standard Deviation|Mean
2617250|NCT01982240|Secondary|Change From Baseline in Stool Consistency Score Over the 12-week Treatment Period, Mean Replacement Approach|"The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale [BSFS] from 1 to 7.~= separate hard lumps like nuts (difficult to pass)~= sausage shaped but lumpy~= like a sausage but with cracks on its surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges (passed easily)~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces (entirely liquid)"|12-Week Treatment Period|The ITT (Intent-to-treat) population was used for analysis.|||score on a scale||Standard Deviation|Mean
2617251|NCT01982240|Secondary|Change From Baseline in SBM (SBMs/Week) Over 12-week Treatment Period, Mean Replacement Approach|The change from baseline in the number of Spontaneous Bowel Movement (SBM) over the 12-week Treatment Period was assessed. Baseline was the mean number of SBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly SBM totals were derived from the daily diary entries reported during the Treatment Period in the BM and Symptom Diary.|12-Week Treatment Period|The ITT (Intent-to-treat) population was used for analysis.|||SBMs per week||Standard Deviation|Mean
2617252|NCT01982240|Secondary|Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach|A Complete Spontaneous Bowel Movement (CSBM) was a Bowel Movement (BM) that occurred in the absence of laxative use within 24 hours of the BM and the patient reported a feeling of complete evacuation. A weekly responder had 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week.|12-Week Treatment Period|The ITT (Intent-to-treat) population was used for analysis.|||CSBMs per week||Standard Deviation|Mean
2617253|NCT01982240|Primary|Number of Durable Overall CSBM Responders , Mean Replacement Approach|A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, included at least 3 of the last 4 weeks. A CSBM weekly responder was defined as a patient who has ≥ 3 Complete Spontaneous Bowel Movements (CSBMs) per week and an increase from baseline of ≥1 CSBM for that week. A CSBM was a bowel movement that occurred in the absence of laxative use within 24 hours and was associated with the feeling of complete evacuation.|12-week Treatment Period|The ITT (Intent-to-treat) population was used for analysis.|||Participants|||Count of Participants
2617254|NCT01982123|Secondary|Radiation Dose With 50% Decrease in Lung Perfusion, Assessed Using 99mTc-MAA and 99mTc-DTPA SPECT/CT|For lung tissue inside the radiation field, changes in tracer uptake at the global lung, regional lung, and lung image voxel scales (compared to baseline) will be plotted against the radiation dose at the same scales to generate multiscale radiation dose response curves. These curves will be fit to linear and sigmoid dose-response functions. Lung regions in the upper quartile and lower quartile of ventilation and perfusion will also be separated out, and separate radiation dose response curves per region will be generated. We report here the dose at which there is a 50% decrease in lung perfusion based on the above analysis.|Baseline to up to 3 months post-treatment||||Gy||Full Range|Median
2617255|NCT01982123|Primary|Spatial Stability of Lung Perfusion and Ventilation Over Time, as Assessed Using 99mTc-MAA SPECT/CT|Perfusion and ventilation on SPECT/CT pre-radiation, mid-radiation, and post-radiation were compared to assess stability over time. Coefficient of determination (R²) was generated based on voxel-based comparisons between scans (R²=1 means perfect reproducibility in perfusion and ventilation between scans), based on regions outside the radiation field.|Baseline to up to 3 months post-treatment||||correlation coefficient|||Number
2617256|NCT01981967|Secondary|Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV®|Adverse Events of Special Interest (AESIs) included hypersensitivity/allergic reactions, neurological events (including febrile convulsions), and vaccine failure.|Day O up to Day 60 post-vaccination|Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set|||Participants|||Number
2617257|NCT01981967|Primary|Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV®||Day O up to Day 60 post-vaccination|Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set|||Participants|||Number
2617258|NCT01981967|Primary|Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV®||30 minutes post-vaccination up to Day 60 post-vaccination|Safety outcome were assessed in subjects who had received the study vaccine, the Safety Analysis Set|||Participants|||Number
2617259|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Family Cohesion Impact Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
2617260|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Time Impact Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
2617261|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Parent-Emotional Impact Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
2617262|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Change in Health Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
2617263|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 - General Health Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
2617264|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Behaviour Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
2617265|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Temperament and Moods Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
2617266|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Pain Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
2617267|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Growth and Development Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
2617268|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in ITQoL SF-47 - Physical Abilities Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with data available at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
2617269|NCT01981954|Secondary|Change From Baseline to Week 24 and 52 in Infant and Toddler Quality of Life Short Form-47 Questionnaire (ITQoL SF-47) - Overall Health Score|The ITQoL SF-47 consisted of 47 individual items and was filled in by the child's parent. The individual items are based on Likert scales with either 5 responses (coded as 1 through to 5) or 4 responses (coded as 1 through to 4). From subsets of these coded values, 11 scales are derived: overall health, physical activities, development, discomfort, moods and temperaments, perceptions of current past and future health and perception of changes. Each scale score ranges from 0 (worst possible) to 100 (best possible).|Baseline and Weeks 24, 52|FAS population with available data at baseline and at each time point.|||units on a scale||Standard Deviation|Mean
2617270|NCT01981954|Secondary|Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 52|Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 52 visit|FAS population.|||percentage of days with incontinence|Days||Number
2617271|NCT01981954|Secondary|Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 36|Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 36 visit|FAS population.|||percentage of days with incontinence|Days||Number
2617272|NCT01981954|Secondary|Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 24|Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 24 visit|FAS population.|||percentage of days with incontinence|Days||Number
2617273|NCT01981954|Secondary|Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 12|Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 12 visit|FAS population|||percentage of days with incontinence|Days||Number
2617274|NCT01981954|Secondary|Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 9|Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 9 visit|FAS population.|||percentage of days with incontinence|Days||Number
2617275|NCT01981954|Secondary|Percentage of Days With Incontinence for Each Hour of 24 Hour Day During Week 6|Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 6 visit|FAS population.|||percentage of days with incontinence|Days||Number
2617276|NCT01981954|Secondary|Percentage of Days With of Incontinence for Each Hour of 24 Hour Day During Week 3|Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 3 visit|FAS population.|||percentage of days with incontinence|Days||Number
2617277|NCT01981954|Secondary|Percentage of Days With Incontinence for Each Hour of 24 Hour Day at Baseline|Incontinence was defined as leakage where a diaper is not used, or dampness where a diaper is used. For each one hour period of the 24 hour day, the percentage of days with incontinence was assessed as the number of days with incontinence occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Baseline visit|FAS population.|||percentage of days with incontinence|Days||Number
2617278|NCT01981954|Secondary|Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 52|For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all subjects. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 52 visit|FAS population.|||percentage of days with catheterization|Days||Number
2617279|NCT01981954|Secondary|Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 36|For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 36 visit|FAS population.|||percentage of days with catheterization|Days||Number
2617280|NCT01981954|Secondary|Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 24|For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 24 visit|FAS population.|||percentage of days with catheterization|Days||Number
2617281|NCT01981954|Secondary|Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 12|For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 12 visit|FAS population.|||percentage of days with catheterization|Days||Number
2617282|NCT01981954|Secondary|Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 9|For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 9 visit|FAS population.|||percentage of days with catheterization|Days||Number
2617283|NCT01981954|Secondary|Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 6|For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 6 visit|FAS population.|||percentage of days with catheterization|Days||Number
2617284|NCT01981954|Secondary|Percentage of Days With Catheterizations for Each Hour of 24 Hour Day During Week 3|For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Week 3 visit|FAS population.|||percentage of days with catheterization|Days||Number
2617285|NCT01981954|Secondary|Percentage of Days With Catheterizations for Each Hour of 24 Hour Day at Baseline|For each one hour period of the 24 hour day, the percentage of days with catheterization was assessed as the number of days with catheterization occurring within the one hour period divided by the number of valid diary days over all participants. Each participant contributed to up to three days of valid diary data for each visit.|3 days prior to Baseline visit|FAS population.|||percentage of days with catheterization|Days||Number
2617286|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Mean Number of Periods Between the Clean Intermittent Catheterizations (CICs) With Incontinence Per 24 Hours|Participants were required to have 4-6 CICs per day on a schedule fixed for the duration of the study. To calculate the number of periods between CICs with incontinence in a diary day, the diary day was divided into periods between CICs (i.e. inter-CIC periods). The hour period, rather than the exact time, of each CIC and incontinence episode was recorded in the diary. When an incontinence episode and a CIC were marked in the same hour period, the incontinence episode was counted as occurring prior to the CIC (when the bladder had not yet emptied), rather than after it (when the bladder had recently been emptied), i.e. the inter-CIC period ended with the hour in which the CIC was recorded. The mean number of periods between CICs with incontinence per 24 hours was the number of periods between CICs when incontinence occurred, divided by the total number of valid diary days.|Baseline and Weeks 3, 6, 9, 12, 24, 36, 52|FAS population with data available at baseline and at each time point.|||periods||Standard Deviation|Mean
2617287|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average First Morning Catheterized Volume|The first morning catheterized volume was the volume associated with the first morning catheterization. The average first morning catheterized volume was calculated as the average of the available first morning catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days are concurrent.|Baseline and Weeks 3, 6, 9, 12, 24, 36, 52|FAS population with data available at baseline and at each time point.|||mL||Standard Deviation|Mean
2617288|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Maximum Catheterized Volume (MCV)|The maximum catheterized volume per day was calculated using all available (non-zero) catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days were concurrent. The maximum value was calculated separately for each measuring day and the mean of these two values was used.|Baseline and Weeks 3, 6, 9, 12, 24, 36, 52|FAS population with data available at baseline and at each time point.|||mL||Standard Deviation|Mean
2617289|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24, 36 and 52 in Average Catheterized Volume Per Catheterization|The average catheterized volume per catheterization was calculated using all available (non-zero) catheterized volumes recorded over both of the 2 measuring days in the diary, whether or not these 2 days were concurrent. Catheterized volumes were recorded for 2 days in a participant diary prior to each visit. Four to six catheterizations were performed every day.|Baseline and Weeks 3, 6, 9, 12, 24, 36, 52|FAS population with data available at baseline and at each time point.|||mL||Standard Deviation|Mean
2617290|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until Leakage or End of Bladder-Filling||Baseline and Weeks 3, 6, 9, 12, 24, 52|FAS population with data available at baseline and at each time point.|||contractions||Standard Deviation|Mean
2617291|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 30 cmH20 Detrusor Pressure|Bladder volume as assessed by urodynamics.|Baseline and Weeks 3, 6, 9, 12, 24, 52|FAS population with data available at baseline and at each time point and whose pressure reached 30 cmH2O.|||mL||Standard Deviation|Mean
2617292|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 20 cmH20 Detrusor Pressure|Bladder volume as assessed by urodynamics.|Baseline and Weeks 3, 6, 9, 12, 24, 52|FAS population with data available at baseline and at each time point and whose pressure reached 20 cmH2O.|||mL||Standard Deviation|Mean
2617293|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume at 10 cmH20 Detrusor Pressure|Bladder volume as assessed by urodynamics.|Baseline and Weeks 3, 6, 9, 12, 24, 52|FAS population with data available at baseline and at each time point and whose pressure reached 10 cmH2O.|||mL||Standard Deviation|Mean
2617294|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Volume Until First Detrusor Contraction (> 15 cmH2O)|Bladder volume as assessed by urodynamics.|Baseline and Weeks 3, 6, 9, 12, 24, 52|FAS population with data available at baseline and at each time point and excluding participants who did not have a detrusor contraction.|||mL||Standard Deviation|Mean
2617295|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Catheterized Volume 5 Minutes After End of Bladder-Filling|Catheterized volume was measured when the bladder was emptied via catheterization 5 minutes after the end of bladder-filling.|Baseline and Weeks 3, 6, 9, 12, 24, 52|FAS population with available data at baseline and at each time point.|||mL||Standard Deviation|Mean
2617296|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure 5 Minutes After End of Bladder-Filling|Detrusor pressure was expressed as bladder pressure minus intra-abdominal pressure as assessed by urodynamics.|Baseline and Weeks 3, 6, 9, 12, 24, 52|FAS population with with available data at baseline and at each time point.|||cmH2O||Standard Deviation|Mean
2617297|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Detrusor Pressure at End of Bladder-Filling|Detrusor pressure was expressed as bladder pressure minus intra-abdominal pressure as assessed by urodynamics.|Baseline and Weeks 3, 6, 9, 12, 24, 52|FAS population with available data at baseline and at each time point.|||cmH2O||Standard Deviation|Mean
2617298|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12, 24 and 52 in Bladder Compliance|Bladder compliance gives an indication of the elasticity of the bladder wall. Bladder compliance was calculated by dividing the change in volume during the filling of the bladder by the change in detrusor pressure during that change in bladder volume using urodynamic assessments. The values for bladder volume and detrusor pressure at the beginning and end of filling were taken and used.|Baseline and Weeks 3, 6, 9, 12, 24, 52|FAS population with available data at baseline and at each time point.|||mL/cmH2O||Standard Deviation|Mean
2617352|NCT01981057|Secondary|Calcium|"Prescriptions for calcium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks|||||||
2617299|NCT01981954|Secondary|Change From Baseline to Weeks 3, 6, 9, 12 and 52 in MCC|MCC was the volume instilled into the bladder prior to leakage or end of bladder-filling (whichever was reached first) as assessed by urodynamics (procedure: the bladder was to be filled until voiding/leakage began, or until it was stopped because either the participant experienced pain or discomfort or 135% of EBC was reached for participants ≥ 2 years or of MCV for participants aged 6 months to < 2 years. The participants' bladder was emptied via catheterization).|Baseline and Weeks 3, 6, 9, 12, 52|FAS population with available data at baseline and at each time point.|||mL||Standard Deviation|Mean
2617300|NCT01981954|Primary|Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)|MCC was the volume instilled into the bladder prior to leakage or end of bladder-filling (whichever was reached first), as assessed by urodynamics (procedure: the bladder was to be filled until voiding/leakage began, or until it was stopped because either the participant experienced pain or discomfort or 135% of expected bladder capacity [EBC] was reached for participants ≥ 2 years or of maximum catheterized volume [MCV] for participants aged 6 months to < 2 years; the participants' bladder was emptied via catheterization).|Baseline and Week 24|Full Analysis Set (FAS), which consisted of all participants who took at least one dose of study drug and provided both valid baseline and at least one post-baseline value for the primary efficacy endpoint.|||mL||Standard Deviation|Mean
2617301|NCT01981863|Other Pre-specified|Length of Time Between Incision and Cardiopulmonary Bypass|Mean Length of Time from Incision to Cardiopulmonary Bypass|From incision to bypass, up to 3 hours||||Minutes||Standard Deviation|Mean
2617302|NCT01981863|Secondary|Value of Thromboelastography as Monitor of Fibrinolysis|Thromboelastography may display if fibrinolysis is present|6 months||||percentage of clot||Full Range|Median
2617303|NCT01981863|Primary|Di-Dimer Increase Before Cardiopulmonary Bypass|Change in Di-dimer between preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients.|6 months|D-Dimer from preoperative value and value immediately before cardiopulmonary bypass in cardiac surgery patients|||ng/mL||Full Range|Median
2617304|NCT01981759|Secondary|Change in Alternate Beliefs Exercise (ABE)|"The Alternate Belief Exercise is a measurement of cognitive flexibility. The scores range from 0-21, and a higher score indicates an increased number of alternative beliefs reported.~This outcome measurement reports the change in number of alternate beliefs generated from weeks 3 to 4 as a predictor of improvement of the PSYRATS Delusions Subscale total score at 12 weeks. Thus a higher score in this outcome measurement indicates a greater number of alternative beliefs reported at week 4 as compared to week 3. This implies greater cognitive flexibility at week 4 as compared to week 3 directly after drug administration."|Week 3 to Week 4|Two participants were randomized and took medication (placebo or DCS) at week 3, but were lost to follow up between week 3 and week 4. One participant was randomized at week 3 but did not take medication or complete the ABE exercise at week 3. These three participants are not included in the reported data.|||Change in a score||Standard Deviation|Mean
2617305|NCT01981759|Secondary|Change in Logical Memory Test-WMS-III|"The Logical Memory Test of the Wechsler Memory Scale is a measure of verbal declarative memory. We are using it to evaluate memory consolidation by analyzing the number of thematic elements recalled after a delay of 7 days. Participants are read two different stories—one at Screening visit #2 and one at Baseline. They are asked to recall specific items and narrative themes after 7 days. Scores range from 0-7, 7 indicating perfect thematic recall, and 0 indicating no thematic elements were remembered and worse thematic recall.~We hypothesize that improved memory consolidation (assessed with the Logical Memory Test) tested 7 days after the first dose of D-cycloserine will predict improvement of delusional scores measured by the PSYRATS-D.~The reported outcome (change in Logical Memory Test score) was calculated by subtracting the screening visit 2 score from the baseline score for each participant."|7 days after Baseline, and 7 days after Screening visit 2|Reported summary statistics are for participants randomized at three weeks. One randomized participant is excluded from these results as they did not complete the Logical Memory Test at the baseline visit.|||Change in a score||Standard Deviation|Mean
2617306|NCT01981759|Primary|Change in Psychotic Symptoms Rating Scale-Delusions (PSYRATS-D)|The change in the Delusions subscale total of the Psychotic Symptoms Rating Scale (PSYRATS) from Baseline to Week 12. The Delusions subscale is a composite score of 6 items each rated from 0-4 with 4 indicating more severe symptomology. The Delusions subscale has a possible range of 0-24.|Baseline to Week 12|For week 12 values, only those who completed the week 12 assessments are included in the analysis.|||units on a scale||Standard Deviation|Mean
2617307|NCT01981616|Secondary|Number of Participants With Adverse Events (AEs)|"An AE was defined as any untoward medical occurrence in a subject administered a pharmaceutical product; the untoward medical occurrence did not necessarily have a causal relationship with this treatment.~Serious adverse event (SAE) meant any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly/birth defect or was a medically important event. Relationship of each AE to study drug was determined by the Investigator."|From the first dose of study medication through Day 127|The Safety Population was defined as all participants who received any amount of study drug (vedolizumab or placebo) based on what they actually received.|||participants|||Number
2617308|NCT01981616|Secondary|Anti-Hepatitis B Surface Antibody Over Time||Baseline and Days 18, 32, 60 and 74|"Per Protocol Population; n indicates the number of participants with available data at each time point."|||IU/L||Geometric Coefficient of Variation|Geometric Mean
2617309|NCT01981616|Secondary|Percentage of Participants With an Immune Response to Oral Cholera Vaccine|A positive immune response was defined as an increase of greater than 4-fold over the Baseline immunoglobulin M (IgM), IgG, or IgA anticholera antibodies.|Baseline and Day 74|The Dukoral Population was defined as all participants who had evaluable samples for assessing immune response to cholera vaccine (Dukoral) vaccine at any visit.|||percentage of participants||95% Confidence Interval|Number
2617310|NCT01981616|Primary|Percentage of Participants With an Immune Response to Hepatitis B Vaccine at Day 74|Immune response was defined as hepatitis B surface antibody (anti-HBs) ≥ 10 IU/L.|Day 74|The Per Protocol Population consisted of all participants who received any amount of study drug and who met predefined evaluability criteria, including receiving the correct and complete dose of study drug, completed both Baseline and day 72 serology assessments and full schedule of hepatitis B vaccine and immunomodulator or corticosteroid use.|||percentage of participants||95% Confidence Interval|Number
2617311|NCT01981590|Secondary|Number of Observed Side Effects|All observed side effects like potential physiologic changes or side effects associated with transvenous nerve stimulation such as pain, hiccup, skeletal muscular tremor, nausea, and sinus node activation|From procedure to 2-4 weeks post-procedure|All 15 enrolled patients who were undergoing an atrial flutter or atrial fibrillation ablation procedure|||Side Effect|||Number
2617312|NCT01981590|Secondary|Number of Patients With Observed Side Effects|Number of patients with observed side effects like potential physiologic changes or side effects associated with transvenous nerve stimulation|From procedure to 2-4 weeks post-procedure|All 15 enrolled patients who were undergoing an atrial flutter or atrial fibrillation ablation procedure|||Participants|||Count of Participants
2617313|NCT01981590|Secondary|Number of Patients With Response to Stimulation (Tidal Volume)|Number of Patients With Response to Stimulation, defined by measured tidal volume of 200 ml or more induced by a pacing stimulus with pulse amplitude of 4 V or less|one hour|All 15 enrolled patients who were undergoing an atrial flutter or atrial fibrillation ablation procedure|||Participants|||Count of Participants
2617314|NCT01981590|Primary|Number of Patients With Response to Stimulation (Diaphragmatic Movement Achieved)|Number of Patients With Response to Stimulation, defined by Presence of Movement of the Diaphragm Induced by a Pacing Stimulus With Pulse Amplitude of 10 V or Less|one hour|All 15 enrolled patients who were undergoing an atrial flutter or atrial fibrillation ablation procedure|||Participants|||Count of Participants
2617315|NCT01981564|Secondary|Emergency Department (ED) Visits for Asthma|Number of emergency department visits for asthma in the past 3 months|3 months|No data for one participant in the control group for this outcome|||visits||Standard Deviation|Mean
2617316|NCT01981564|Primary|Symptom Days|Symptom days for asthma during past 14 days|3 months||||symptom days over past 14 days||Standard Deviation|Mean
2617317|NCT01981551|Secondary|Mean MD Anderson Symptom Inventory Scores After Treatment|The MD Anderson Symptoms Inventory (MDSAI) questionnaire includes questions regarding 13 symptoms commonly experienced by patients with cancer and 6 additional items that assess the extent to which these symptoms interfered with how patients felt and were able to function. The 0-10 scale (0=none, 1-4=mild, 5-6=moderate, and 7-10=severe) assesses how patients felt and were able to function over the previous 24 hours. A component score representing symptom severity is obtained by taking the average of the 13 symptom items (e.g., pain, fatigue, etc.) together. A component score representing symptom distress is obtaining by averaging the 6 symptom interference items (e.g., general activity, mood, etc.).|At baseline prior to drug administration and at least every 6 cycles of drug (18 weeks) up to 20 months of treatment.||||Scores on a scale||Standard Deviation|Mean
2617318|NCT01981551|Secondary|Number of Participants With Somatic or Germline Mutations Identified in Adenomatous Polyposis Coli Gene (APC) or Catenin Beta-1 (CTNNB1) Genes|Tumor and blood samples were obtained from participants and genotyped for somatic and germline mutations.|Baseline||||Participants|||Count of Participants
2617319|NCT01981551|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 66 months and 27 days.||||Participants|||Count of Participants
2617320|NCT01981551|Primary|Number of Participants With a Complete Response (CR) + Partial Response (PR)|Complete Response + Partial Response was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progressions. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|20 months||||Participants|||Count of Participants
2617321|NCT01981473|Secondary|Correlation of Antidrug Antibody Titers With Trough Drug Concentration.|Correlation of antidrug antibody titers with trough drug concentration analysed using Spearman correlation coefficient.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. No participants for etanercept arm were antibody positive, therefore there is no correlation to report.|||Correlation coefficient|||Number
2617322|NCT01981473|Secondary|Correlation of Antidrug Antibody Titers With Efficacy Measures.|Correlation of antidrug antibody titers with efficacy measures analysed using Spearman correlation coefficient.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit. No participants for etanercept arm were antibody positive, therefore there is no correlation to report.|||Correlation coefficient|||Number
2617323|NCT01981473|Secondary|Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|HAQ DI (<=0.5) scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||percentage of participants|||Number
2617353|NCT01981057|Secondary|Potassium|"Prescriptions for Potassium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks|||||||
2617324|NCT01981473|Secondary|Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|"The HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing no difficulty, 1 as some difficulty, 2 as much difficulty, and 3 as unable to do. Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. The total score range for the HAQ-DI scale, minimum score was 0 (best), maximum score was 3 (worst)."|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||Units on a scale||Standard Deviation|Mean
2617325|NCT01981473|Secondary|Disease Activity Score, 28 Joint Count, Calculated With C-reactive Protein (DAS28-CRP) for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0 100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0-100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject's General Health VAS assessment.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||Units on a scale||Standard Deviation|Mean
2617326|NCT01981473|Secondary|Disease Activity Score Based on a 28-joint Count (DAS28), Calculated With Erythrocyte Sedimentation Rate for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0-100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0- 100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject's General Health VAS assessment.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||Units on a scale||Standard Deviation|Mean
2617327|NCT01981473|Secondary|The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|The SDAI Total Scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. SDAI = DAS 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician's Global Assessment (0-10) + Subject's Global Assessment (0-10) + C-reactive protein (CRP) (in mg/dL). The total score range is 0-86. Score interpretation: Remission SDAI ≤ 3.3; Low Disease Activity SDAI > 3.3 and ≤ 11; Moderate Disease Activity SDAI > 11 and ≤ 26; High Disease Activity SDAI > 26.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||units on a scale||Standard Deviation|Mean
2617328|NCT01981473|Secondary|The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|The CDAI total scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. CDAI = Disease activity score (DAS) 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician's Global Assessment (0-10) + Subject's Global Assessment (0-10). The total score range is 0-76. Score interpretation: Remission ≤ 2.8; Low Disease Activity CDAI > 2.8 and ≤ 10; Moderate Disease Activity CDAI > 10 and ≤ 22; High Disease Activity CDAI > 22.|1 Day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||units on a scale||Standard Deviation|Mean
2617329|NCT01981473|Secondary|Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab.|Percentage of participants positive for antidrug antibodies among those treated with etanercept, adalimumab, or infliximab were determined.|1 Day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||Percentage of participants|||Number
2617330|NCT01981473|Secondary|Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.|Serum trough drug concentrations for etanercept, adalimumab, and infliximab compared between participants who are antidrug antibody positive versus negative. Units of measurement for Serum trough drug concentration is µg/mL.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||µg/mL||Standard Deviation|Mean
2617354|NCT01981057|Secondary|Sodium|"Prescriptions for sodium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks|||||||
2620703|NCT01953237|Primary|Adherence to Antipsychotic Medications|A measure of the extent to which participants self-reported taking their antipsychotic medications as prescribed|3 month period||||percentage of days adherent||Standard Deviation|Mean
2617331|NCT01981473|Secondary|Percentage of Participants With Low Disease Activity (LDA) (DAS28 ESR Score ≤ 3.2) Among Those Who Are Antidrug Antibody Positive Versus Negative (All Patients Receiving Etanercept, Adalimumab, or Infliximab Combined).|Percentage of participants with Low Disease Activity (LDA) (Disease Activity Score based on a 28-joint count [DAS28] Erythrocyte sedimentation rate [ESR] score ≤3.2) among those who are antidrug antibody positive versus negative (all participants receiving etanercept, adalimumab, or infliximab combined).|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||percentage of participants|||Number
2617332|NCT01981473|Primary|Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab).|Percentage of participants positive for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab) was determined.|1 day|FAS included participants who were diagnosed of RA and who received continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months to 24 months prior to study assessment visit.|||Percentage of participants|||Number
2617333|NCT01981356|Secondary|Experimental Treatment Acceptability|Assessed by patient reported therapeutic alliance, measured by the well-validated Working Alliance Inventory (WAI; Horvath & Greenberg, 1989; range 1 to 7, higher score indicated better outcome).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).||||units on a scale||Standard Deviation|Mean
2617334|NCT01981356|Secondary|Experimental Treatment Acceptability|Assessed by patient reported treatment satisfaction, as assessed by the well-validated Client Satisfaction Questionnaire - 8 (CSQ-8; Attkisson & Zwick, 1982; range 0 to 5, higher scores indicate better outcome).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).||||units on a scale||Standard Deviation|Mean
2617335|NCT01981356|Secondary|Experimental Treatment Safety|Assessed by the occurrence of zero adverse events attributable to ACT.|8-month study period|Although 18 participants were randomized to treatment condition, the consent of two participants was invalid. Thus, their data could not be utilized and is not reported other than for identification of participant flow.|||adverse events|||Number
2617336|NCT01981356|Secondary|Experimental Treatment Acceptability|Assessed by patient attendance of at least 3 out of 4 sessions on average.|8-month study period||||sessions||Standard Deviation|Mean
2617337|NCT01981356|Secondary|Experimental Treatment Feasibility|Assessed by our ability to recruit and consent 2 eligible participants per week (for 40 weeks) to participate in random assignment to ACT + TAU or TAU.|8-month study period|Although 18 participants were randomized to treatment condition, the consent of two participants was invalid. Thus, their data could not be utilized and is not reported other than for identification of participant flow.|||participants|||Number
2617338|NCT01981356|Secondary|Barriers and Facilitators to Implementation|We will conduct 30-60 minute semi-structured interviews structured around the RE-AIM framework (Glasgow et al., 1999), and utilizing the RE-AIM Planning Tool (Forman et al., 2010). The RE-AIM framework identifies, for example, barriers that limit patients, staff, and site participation in the intervention and how to address them, and provider and patient perceptions about why the intervention is successful at achieving better outcomes.|8-month study period|Data regarding barriers and facilitators was not obtained from patient participants, but was obtained from study staff, who were not assigned to treatment condition.|||Participants providing data|||Number
2617339|NCT01981356|Secondary|Cost of Stay|Obtained by: (a) obtaining length obtained by: (a) obtaining length-of-stay (in hours) on the inpatient unit for all study participants, (b) calculating the cost of stay for each participant by multiplying the length-of-stay by the dollar amount associated with inpatient treatment of psychosis (e.g., $1,297/day or $54/hour in 2011; Blow et al., 2011), and (c) summing the cost of stay across participants in each treatment condition.|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|Data regarding length of stay not available for one participant in each condition, both of whom had not been discharged by the end of the study period.|||Dollars||Standard Deviation|Mean
2617340|NCT01981356|Secondary|Positive and Negative Affect Scale (Watson et al., 1988)|Assesses short-term changes in global positive and negative affect in addition to changes in specific types of emotions (e.g., afraid, excited, guilty). Positive and negative affect subscales consist of ten items each, averaged to obtain scale scores. Scale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest (5) to lowest (1) possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest (1) to highest (5) possible value on scale from baseline to follow-up. Increases in positive affect percentage change and decreases in negative affect change are considered better outcomes.|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).||||percentage of total possible change||Standard Deviation|Mean
2617341|NCT01981356|Secondary|Acceptance and Action Questionnaire - II (Bond et al.., 2011)|Assesses changes in the primary mechanism thought to contribute to change in ACT: acceptance. All scale items were averaged to obtain a total scale score. Total scale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest (7) to lowest (1) possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest (1) to highest (7) possible value on scale from baseline to follow-up. Increases in percentage change are considered better outcomes (i.e., increased acceptance).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|Out of participants who completed follow-up assessments, one participant in each condition did not complete the Acceptance and Action Questionnaire - II.|||percentage of total possible change||Standard Deviation|Mean
2617499|NCT01978912|Secondary|Number of Participants Serum Concentrations of KTP-001 Below the Limit of Quantification (BLQ)|The serum concentrations of KTP-001 were below the limit of quantification (BLQ) (<100 ng/mL) at all time points in all participants|13 weeks||||Participants|||Count of Participants
2617342|NCT01981356|Secondary|Frequency, Believability, and Distress Symptom Scale (Gaudiano & Herbert, 2006)|Assesses changes in the frequency, believability, and associated distress of psychosis symptoms. Frequency, believability, and distress subscales consist of two items each, one assessing delusions and one assessing hallucinations, averaged to obtain subscale scores. Subscale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest to lowest possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest to highest possible value on scale from baseline to follow-up. Decreases in percentage change are considered better outcomes (i.e., reduced frequency, believability and distress).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).|Out of participants who completed follow-up assessments, one participant in each condition did not complete the Frequency, Believability, and Distress Symptom Scale.|||percentage of total possible change||Standard Deviation|Mean
2617343|NCT01981356|Primary|Brief Psychiatric Rating Scale (Overall & Gorham, 1962)|Assesses changes in broad symptom domains (affect disturbance, positive symptoms, negative symptoms, resistance/hostility, activation) and specific symptoms (e.g., delusions). All scale items were averaged to obtain a total scale score. Scale scores are reported as percentage of total possible change, calculated as follow-up score minus baseline score divided by total points in scale. Minimum score is -100% change (a decrease of 100% of total possible score from baseline to follow-up assessment). Minimum score is akin to a change from the highest (7) to lowest (1) possible value on scale from baseline to follow-up. Maximum score is +100% change (an increase of 100% of total possible score from baseline to follow-up assessment). Maximum score is akin to a change from the lowest (1) to highest (7) possible value on scale from baseline to follow-up. Decreases in percentage change are considered better outcomes (i.e., reduced symptoms).|Participants were followed for the duration of hospital stay (Mean = 24.0 days, SD = 15.8).||||percentage of total possible change||Standard Deviation|Mean
2617344|NCT01981122|Primary|To Evaluate Peripheral PA2024-specific T Cell Proliferation Response to Sipuleucel-T Over Time Via a T Cell Stimulation Index (SI).|PA2024-specific T cell proliferation responses over time will be compared between the concurrent arm and sequential arm using a repeated measurement mixed model analysis. The unit of analysis for the T cell proliferation data is the stimulation index, defined as the median 3H uptake of 3 wells exposed to antigen divided by the median 3H thymidine uptake of 3 wells exposed to media. The stimulation index will be log-transformed prior to analysis.|Each patient was followed for up to 52 weeks after the first dose of sipuleucel-T. Immune sample draws during the treatment period (Week 0 through Week 4) were to be performed at the patient's pre-leukapheresis visits (Pre-Leuk 2 and Pre-Leuk 3).|Summary of Cellular Proliferation Data Through Week 52. All patients with reported data at a specified time-point were analyzed. Number of patients at each time-point differed across the time-points resulting in patient numbers at each time-point that are not equal to the total number of patients analyzed.|||10^3 cells/mL||Standard Deviation|Mean
2617345|NCT01981109|Primary|Occurrence Measured in Time of an Image Showing Positive for M1 (Metastatic Disease) at Baseline to Registration|The primary endpoint for the study will be the occurrence of an imaging study at baseline that is positive for M1 (yes or no) among all patients in the primary analysis population.The primary analysis population consists of patients who had a current diagnosis of having non metastatic (M0) disease at baseline. These patients underwent imaging scans at baseline and were assessed for metastatic (M1) versus non metastatic (M0) disease.|Each enrolled subject will be evaluated at baseline for the occurrence of metastatic disease by positive imaging scan.|There were 206 patients at baseline that had a valuable data that were assessed. The results were 151 patients that had non-metastatic (M0) and 55 patients that had metastatic disease (M1) disease. The study terminated early therefore no further statistical analysis was performed.|||years||Standard Deviation|Mean
2617346|NCT01981096|Secondary|Depressive Symptoms|Children's Depression Inventory: a 27-item validated patient-report measure of depressive symptoms in the past 2 weeks (scores 0 = no depressive symptoms to 54 = most severe symptoms; lower score means less depression/better outcomes)|Baseline, Post-treatment, 3-month follow-up|20 participants randomized to each group. 4 participants dropped out prior to post-treatment and follow-up assessments.|||score on a scale||Standard Deviation|Mean
2617347|NCT01981096|Secondary|Functional Disability|Validated 15-item patient-report measure of difficulties in physical, social and recreational activities in the past 2 weeks (score Min = 0, Max = 60; Lower score means less disability/better outcome)|Baseline, post-treatment and 3-month follow-up|20 participants randomized to each group. 4 participants dropped out prior to post-treatment and follow-up assessments.|||units on a scale||Standard Deviation|Mean
2617348|NCT01981096|Primary|Average Pain Intensity|Average pain intensity in the past week marked on a paper-pencil Visual Analog Scale (Min = 0 {no pain} to Max = 10 {pain as bad as it can be}). Lower scores mean better outcomes.|Baseline, post-treatment and 3-month follow-up|20 participants randomized in each group. 3 dropped out of study before post-treatment and follow-up assessments.|||units on a scale||Standard Deviation|Mean
2617349|NCT01981057|Secondary|Osmolarity|"Osmolarity in parenteral nutrition solutions will be calculated individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks|||||||
2617350|NCT01981057|Secondary|Phosphorous|"Prescriptions for phosphorous in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks|||||||
2617351|NCT01981057|Secondary|Magnesium|"Prescriptions for magnesium in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks|||||||
2617500|NCT01978912|Primary|Number of Participants With Change in 12-lead Electrocardiogram (ECG) and Clinical Laboratory Tests (CLT)|Assessment of the number of participants with change in 12-lead ECG and CLT were assessed from baseline, 24 hours and 13 weeks.|13 weeks||||Participants|||Count of Participants
2617355|NCT01981057|Secondary|Fat|"Prescriptions for fat in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks|||||||
2617356|NCT01981057|Secondary|Carbohydrates|"Prescriptions for carbohydrates in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks|||||||
2617357|NCT01981057|Secondary|Energy|"Prescriptions for energy in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations"|6 weeks|||||||
2617358|NCT01981057|Primary|Protein|"Prescriptions for protein in parenteral nutrition solutions will be ordered individually and flipped with Numeta or vice versa. This mirroring will be performed with the Cato-Pan prescription software. Subsequently the following nutrients will be calculated and compared with each other and with the ESPGHAN recommendations."|6 weeks||||g/kg/d||Full Range|Median
2617359|NCT01980992|Secondary|Incidence of All Serious Adverse Events During the Study.||1 year and 2 Years|Data was available for 22 participants in the Wheat OIT group and 21 participants for the Placebo Crossover group at the end of the study.|||Participants|||Count of Participants
2617360|NCT01980992|Secondary|Number of Subjects That Achieve Desensitization in the Placebo Cross Over Group|The number of subjects that achieve desensitization in the placebo cross over group after 1 year of dosing. Able to consume at least 4443 mg wheat protein on the Week 52 Crossover OFC (4443 mg wheat protein is the amount that was used for the primary endpoint).|2 Years|Two Placebo subjects did not crossover. This outcome measure is only for the Placebo crossover group.|||Participants|||Count of Participants
2617361|NCT01980992|Secondary|Number of Subjects Who Achieve the Targeted Maintenance Dose of Wheat OIT|The number of subjects who achieve the targeted maintenance dose of wheat OIT during the desensitization phase of the study. For Wheat OIT group, reached target dose of 2035 mg wheat powder/1445 mg wheat protein. For placebo group, reached target dose of 2035 mg placebo powder.|44 Weeks||||Participants|||Count of Participants
2617362|NCT01980992|Secondary|Number of Subjects Who Successfully Consume a Wheat Protein Oral Food Challenge|The number of subjects who successfully consume a 7443 mg wheat protein oral food challenge (OFC) 8-10 weeks after therapy discontinuation and after passing the 7443 mg wheat protein OFC at the 2 year time point.This OFC will only be administered to subjects in the initial active treatment group.|8 to 10 weeks after passing the 2 Year OFC|This is not applicable for the Placebo Crossover subjects as they did not complete at 2 Year Tolerance OFC per the protocol.|||Participants|||Count of Participants
2617363|NCT01980992|Primary|The Percentage of Desensitized Participants as Measured by the Ability to Consume at Least 4443 mg of Wheat Protein During a 7443 mg Wheat Protein Oral Food Challenge (OFC) Performed 1 Year After Initiating Treatment.|Determine in wheat allergic children, whether relative to placebo, daily oral administration of Vital Wheat Gluten escalated to a maximum of 2035 mg/day of Vital Wheat Gluten increases desensitization as measured by consuming without dose limiting symptoms 4443 mg of wheat protein on a 7443 mg wheat protein OFC performed 1 year after initiating treatment.|1 Year|All randomized participants were included.|||Participants|||Count of Participants
2617364|NCT01980940|Secondary|Study Parts 1 and 2: Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Study Part 1: up to Day 47; Study Part 2: up to Day 28|Safety analysis set defined as all treated participants (etoricoxib or placebo) based on the treatment received rather than the randomized assignment.|||Participants|||Number
2617365|NCT01980940|Secondary|Study Parts 1 and 2: Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Study Part 1: up to Day 47; Study Part 2: up to Day 28|Safety analysis set defined as all treated participants (etoricoxib or placebo) based on the treatment received rather than the randomized assignment.|||Participants|||Number
2617366|NCT01980940|Secondary|Study Part 2: Percentage of Participants by Category on Patient Global Assessment of Response to Therapy (PGART)|The PGART is a self-administered questionnaire completed by participants. Participant assessment of response of arthritis to study medication was assessed on a 5-point Likert scale ('very well', 'well', 'fair', 'poor', and 'very poor').|Day 2, Day 4, Day 7, Day 11, Day 14, post-trial (up to Day 28)|FAS defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment|||Percentage of participants|||Number
2617367|NCT01980940|Secondary|Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Physical Functioning Scale|The WOMAC VA 3.1 Physical Functioning subscale is a self-administered questionnaire assessing lower extremity physical function due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Physical Functioning subscale had 17 questions with answers to each item assessed on a 100 mm VA scale (0 = no difficulty; 100 = extreme difficulty). The score for each item was summed and the overall score ranged from 0 to 1700 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in physical function.|Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14|FAS defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment|||Units on a scale||Standard Deviation|Mean
2617624|NCT01977625|Secondary|Change in BADDS Total Score|The total BADDS ranged from 0-120 with higher scores meaning greater problems with memory, attention and focus. Difference in BADDS score from Baseline to End of Treatment for each study Arm was calculated.|10 weeks|Participants who completed all 3 scans.|||change in units||Standard Deviation|Mean
2617368|NCT01980940|Secondary|Study Part 2: Change From Baseline in Mean Participant Score on the WOMAC VA 3.1 Stiffness Scale|The WOMAC VA 3.1 Stiffness subscale is a self-administered questionnaire assessing lower extremity stiffness due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Stiffness subscale had two questions with answers to each item assessed on a 100 mm VA scale (0 = no stiffness; 100 = extreme stiffness). The score for each item was summed and the overall score ranged from 0 to 200 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in stiffness.|Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14|FAS defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment|||Units on a scale||Standard Deviation|Mean
2617369|NCT01980940|Primary|Study Part 2: Change From Baseline in Mean Participant Score on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Visual Analog (VA) 3.1 Pain Scale|The WOMAC VA 3.1 Pain subscale is a self-administered questionnaire assessing lower extremity pain due to osteoarthritis that was completed by participants 2 to 3 hours post morning dose. The WOMAC Pain Subscale had five questions with answers to each item assessed on a 100 mm VA scale (0 = no pain; 100 = extreme pain). The score for each item was summed and the overall score ranged from 0 to 500 (increasing severity). The time weighted average up to day x was calculated as the sum of rectangles under the curve for successive intervals prior to day x as defined by timepoints at which assessments were made. The time weighted change from baseline was calculated. A negative mean change from baseline indicates improvement in pain.|Baseline (Day -1), Day 2, Day 4, Day 7, Day 11, Day 14|Full analysis set (FAS) defined as all treated participants (etoricoxib or placebo) without major entry criteria violation and with at least one valid post-baseline primary efficacy assessment|||Units on a scale||Standard Deviation|Mean
2617370|NCT01980940|Primary|Study Part 1: Area Under the Concentration-time Curve of ETOR From Time 0 to Last (AUC0-last) After Single Dosing|Area under the observed concentration-time curve from time zero to the last quantifiable time point determined for the period up to 72 hours post-single application. The area was calculated according to the linear up/log down trapezoidal rule. AUC0-last is an estimate of total plasma exposure. Descriptive statistics are expressed as the GLSM. AUC with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).|Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application|PK analysis set defined as all participants treated with etoricoxib with sufficient PK data for reliable estimation of the PK parameter of interest (AUC0-last) without any protocol violation that interferes with PK data interpretation|||mg||90% Confidence Interval|Least Squares Mean
2617371|NCT01980940|Primary|Study Part 1: Time to Maximum Concentration (Tmax) of ETOR After Single Dosing|Tmax determined for the period up to 72 hours post-single application.|Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application|PK analysis set defined as all participants treated with etoricoxib with sufficient PK data for reliable estimation of the PK parameter of interest (Tmax) without any protocol violation that interferes with PK data interpretation|||hour||Full Range|Median
2617372|NCT01980940|Primary|Study Part 1: Maximum Concentration (Cmax) of ETOR After Single Dosing|Cmax determined for the period up to 72 hours post-single application. Descriptive statistics are expressed as the geometric least squares mean (GLSM). Cmax with value 0 included in calculation of GLSMs with a value of 0.5*LLOQ (=0.5 h*ng/ml).|Predose and 0.5, 1, 2, 3, 4, 5, 6, 7, 9, 12, 16, 24, 36, 48, and 72 hours post-application|PK analysis set defined as all participants treated with etoricoxib with sufficient PK data for reliable estimation of the PK parameter of interest (Cmax) without any protocol violation that interferes with PK data interpretation|||mg||90% Confidence Interval|Least Squares Mean
2617373|NCT01980914|Secondary|Alteration in Cardiac Rhythm|To determine if there is a correlation between hypoglycemia and cardiac rhythm, alterations in cardiovascular autonomic function and myocardial ischemia.|6 days||||Participants|||Count of Participants
2617374|NCT01980914|Primary|Number of Participants With Hypoglycemia (Blood Sugar Level <70 mg/dl|Track hypoglycemia with continuous glucose monitor. Subjects had measured their glucose using a glucometer 4 times each day during this period and were also got a log book to keep track of glucose values. They were also asked to record any symptoms of hypoglycemia. At the end of 6 days the sensor was removed.|6 days|Only participants who completed the study were analyzed|||Participants|||Count of Participants
2617375|NCT01980888|Secondary|Minimal Residual Disease Negativity Rate at Week 36|Minimal residual disease (MRD) negativity rate is defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation or at least 12 weeks after the last dose of rituximab or bendamustine (whichever is later) for participants receiving the final dose of rituximab after the original scheduled date. MRD negativity rate was to be assessed by an IRC.|Up to 22 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
2617376|NCT01980888|Secondary|Overall Survival|Overall survival is defined as the interval from randomization to death from any cause. Overall survival was to be assessed by an IRC.|Up to 22 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
2617377|NCT01980888|Secondary|Complete Response Rate|Complete response rate is defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.|Up to 22 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
2617378|NCT01980888|Secondary|Nodal Response Rate|Nodal response rate is defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.|Up to 22 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
2617379|NCT01980888|Secondary|Overall Response Rate|Overall response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an IRC.|Up to 22 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
2617380|NCT01980888|Primary|Progression-Free Survival|Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).|Up to 22 months|"Intent to Treat (ITT) analysis set: all participants who are randomized in the study with treatment group designated according to initial randomization.~Due to early study termination, the prespecified efficacy analyses were not conducted. The PFS data presented are investigator assessments rather than IRC assessments."|||months||95% Confidence Interval|Median
2617381|NCT01980875|Secondary|Minimal Residual Disease Negativity Rate at Week 36|Minimal residual disease (MRD) negativity rate is defined as the proportion of participants with MRD < 10^-4 assessed by flow cytometry in bone marrow at Week 36 after therapy initiation. For participants receiving the final dose of obinutuzumab after the original scheduled date, the MRD assessment was performed no less than 12 weeks after the last dose of obinutuzumab. MRD negativity rate was to be assessed by an IRC.|Up to 11 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
2617382|NCT01980875|Secondary|Overall Survival|Overall survival is defined as the interval from randomization to death from any cause. Overall survival was to be assessed by an IRC.|Up to 11 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
2617383|NCT01980875|Secondary|Complete Response Rate|Complete response rate is defined as the proportion of participants who achieve a confirmed complete response. Complete response rate was to be assessed by an IRC.|Up to 11 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
2617384|NCT01980875|Secondary|Nodal Response Rate|Nodal response rate is defined as the proportion of participants who achieve a 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Nodal response rate was to be assessed by an IRC.|Up to 11 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
2617385|NCT01980875|Secondary|Overall Response Rate|Overall response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete or partial response. ORR was to be assessed by an IRC.|Up to 11 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
2617386|NCT01980875|Primary|Progression-Free Survival|Progression-free survival (PFS) is defined as the interval from randomization to the first documentation of definitive disease progression or death from any cause. Definitive disease progression is CLL progression based on standard criteria, excluding lymphocytosis alone. PFS was to be assessed by an independent review committee (IRC).|Up to 11 months|The study was terminated in agreement with the FDA due to urgent safety measures. Complete data were not collected for any participant.||||||
2617387|NCT01980771|Primary|Sexual Behavior|Self-reported sexual behavior is the number of participants that report any unprotected anal and/or vaginal sex in the past ninety days.|Six month follow-up|"352 men completed the six month assessment in the intervention arm; of these 347 provided complete data needed to calculate the outcome measure.~305 men completed the six month assessment in the control arm; of these 303 provided complete data needed to calculate the outcome measure."|||Participants|||Count of Participants
2617388|NCT01980706|Other Pre-specified|Self-reported Sedation on at Least One Occasion by a Participant|Any reporting of feeling sedated/sleepy/drowsy|Every 1-2 weeks up to 16 weeks of active trial|Post-randomization data were unavailable for 2 participants.|||Participants|||Count of Participants
2617389|NCT01980706|Secondary|Carbohydrate-deficient Transferrin|Lab test assessing history of heavy drinking with greater specificity than GGT. Higher levels are indicative of greater levels of drinking.|End of trial, generally 16 weeks|Post-randomization CDT was not collected for all participants.|||% CDT||Standard Error|Least Squares Mean
2617390|NCT01980706|Secondary|Mean Penn Alcohol Craving Scale Score|Penn Alcohol Craving Scale (PACS) is a five-item self administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking as well as the ability to resist drinking. Scores range from a minimum of zero to a maximum of 30. Lower scores are associated with lower level of craving for alcohol. Scores are averaged over the trial.|Every 1-2 weeks up to 16 weeks of active trial||||units on a scale||Standard Error|Least Squares Mean
2617391|NCT01980706|Secondary|Mean Spielberger State-Trait Anxiety Inventory Score [State]|The Spielberger State and Trait Anxiety Inventory (STAI) is a validated self-reporting instrument used to assess anxiety in adults.The inventory consists of state anxiety, which evaluates how the subject feels currently (transient anxiety). The State scale consists of 20 questions, each question rated 1-4, and a higher score indicates greater anxiety. Total score ranges from 20 (no anxiety) to 80 (maximum anxiety). The scores are averaged over the trial.|Every 1-2 weeks up to 16 weeks of active trial||||units on a scale||Standard Error|Least Squares Mean
2617392|NCT01980706|Primary|Mean Percentage of Abstinent Drinking Days|Percent of abstinent days over the course of the trial.|Every 1-2 weeks up to 16 weeks of active trial|Post-randomization data were unavailable for 2 participants.|||percentage of days||Standard Error|Least Squares Mean
2617393|NCT01980706|Primary|Mean Percentage of Heavy Drinking Days|The frequency of heavy drinking days (5 or more drinks for a man and 4 or more drinks for a woman) as percentage during the treatment phase.|Every 1-2 weeks up to 16 weeks of active trial|Post-randomization data were unavailable for 2 participants.|||percentage of heavy drinking days||Standard Error|Least Squares Mean
2617394|NCT01980654|Secondary|Number of Participants With Treatment-emergent Adverse Events|Frequency, severity, and relatedness of treatment-emergent adverse events (AEs) Frequency of treatment-emergent AEs requiring discontinuation of study drug or dose reductions|Up to 45 months||||Participants|||Count of Participants
2617395|NCT01980654|Secondary|Overall Survival (OS)|Subjects will be followed for survival information up to three years after the last dose of study treatment, until new treatment or death, whichever occurs first. OS is defined as the duration of time from the date of the first dose to the date of death from any cause.|Up to 45 months||||months||95% Confidence Interval|Median
2617396|NCT01980654|Secondary|Progression Free Survival (PFS)|PFS is defined as the time interval between the date of the first dose and the date of the earliest occurrence of PD or death due to any cause, whichever occurs first. PD is characterized by any new lesion or increase by >=50% of previously involved sites from nadir.|Up to 45 months||||months||95% Confidence Interval|Median
2617397|NCT01980654|Secondary|Duration of Response (DOR)|DOR is defined as the interval between the date of the first documented response (CR, PR) and the date of the first documented evidence of progressive disease (PD) or death. DOR will be analyzed for the subjects who achieve an overall response during the duration of study.|Up to 45 months||||months||95% Confidence Interval|Median
2617398|NCT01980654|Primary|Overall Response Rate (ORR): Proportion of Subjects Achieving the Best Overall Responses of Complete Response (CR) or Partial Response (PR)|Number of subjects achieving the best overall responses of CR or PR prior to the initiation of the next line of antineoplastic therapy as assessed by investigator per the Cheson et al, 2007 criteria. Target lesions are measured by CT, unless MRI is used as the assessment modality for lesions in anatomical locations not amenable to CT. CR is defined as the disappearance of all evidence of disease. PR is defined as >=50% decrease in the sum of the product of the diameters of up to 6 largest dominant masses.|Subjects in Arm 1 will have imaging assessments every 12 weeks for the first 8 assessments, then every 24 weeks. Subjects in Arm 2 will have imaging assessments starting at week 9, then every 12 weeks for 8 assessments, then every 24 weeks.||||Participants|||Count of Participants
2617399|NCT01980628|Secondary|DOR (Duration of Response)|The DOR analyses is performed on the subset of subjects that achieve CR or PR as determined by IRC. DOR is calculated as the duration of time from the date of first response to the date of progression or death due to any cause.|Analysis was conducted with the cutoff date of 02 Nov 2017, with a median follow-up time of 33.1 months.||||Months||95% Confidence Interval|Median
2617400|NCT01980628|Primary|ORR (Overall Response Rate)|"ORR is defined as the proportion of subjects who achieved complete response (CR), partial response (PR). Response criteria are as outlined in the International Working Group Criteria for NHL, Cheson (2007), with disease assessments performed by an independent review committee (IRC).~Per Cheson:~CR is defined as disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites."|Analysis was conducted with the cutoff date of 02 Nov 2017, with a median follow-up time of 33.1 months.||||Percentage of Participants||95% Confidence Interval|Mean
2617401|NCT01980589|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 and using the following scale:~Grade 1 = Mild, Grade 3 = Moderate; Grade 3 = Severe, Grade 4 = Life-threatening; Grade 5 = Fatal."|From first dose of study drug until 30 days after last dose; median duration of treatment was 31 weeks.|Safety population|||participants|||Number
2617402|NCT01980589|Secondary|Time To Response (TTR)|Time to response is defined as months from treatment start to first documentation of response of partial response or better. Summary of time to response includes confirmed responders of PR or better only.|Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.|Participants with an overall response|||months||Full Range|Median
2617403|NCT01980589|Secondary|Overall Response Rate (ORR)|Participants were evaluated for disease response and progression by the investigator according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). Disease response and progression assessments included serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), serum immunofixation, serum free light chain (SFLC), bone marrow sample (including fluorescent in situ hybridization [FISH]), plasmacytoma evaluation, and skeletal survey. Overall response rate is defined as the percentage of participants with a best response of stringent complete response, complete response, very good partial response (VGPR), or partial response.|Disease response was assessed at the end of each cycle and 30 days after the last treatment; maximum treatment duration was 32 weeks.|Safety population|||percentage of participants||95% Confidence Interval|Number
2617404|NCT01980589|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)|"The MTD is defined as the highest carfilzomib dose at which fewer than 33% of participants experience a treatment-related dose-limiting toxicity (DLT) during the first 28-day cycle. The number of participants who experienced a DLT is reported.~Dose-limiting toxicities are defined as any of the following carfilzomib-related adverse events:~Nonhematologic:~≥ Grade 3 non-hematological toxicity~≥ Grade 3 acute kidney injury (creatinine > 3 × baseline or > 4.0 mg/dL) lasting > 72 hours~Hematologic:~Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 10^9/L) lasting for > 7 days~Febrile neutropenia (ANC < 1.0 × 10^9/L with a fever ≥ 38.3ºC) of any duration~Grade 4 thrombocytopenia (< 25 × 10^9/L) that persists for > 14 days, despite holding treatment~Grade 3 or 4 thrombocytopenia associated with > Grade 1 bleeding"|First cycle treatment over 28-days|The Safety population is defined as all enrolled participants who received any study treatment.|||participants|||Number
2617405|NCT01980524|Other Pre-specified|Stroke Volume|Stroke volume before and after administration of acipimox or placebo|180 minutes||||ml/m2||Standard Deviation|Mean
2617406|NCT01980524|Secondary|Ejection Fraction|Left ventricular ejection fraction before and after administration of acipimox or placebo|180 minutes||||percentage||Standard Deviation|Mean
2617407|NCT01980524|Primary|MYCL|Intramyocardiocellular lipid content (MYCL) before and after administration of acipimox or placebo|180 minutes||||percentage of water signal||Standard Deviation|Mean
2617408|NCT01980485|Primary|Sustained Tobacco Abstinence|Among those who have not smoked in the previous week at visit 7, sustained tobacco abstinence (including no tobacco use in prior 7 days), validated by exhaled CO < 10 ppm at the 6 month visit(8) AND not smoking for any 7 consecutive days during the prior 5 months (definition of a relapse in this study)|6 months|Those who were quit at 1 month|||Participants|||Count of Participants
2617409|NCT01980485|Primary|Number of Participants Reporting no Tobacco Use in the Past 7 Days and Have a Validated CO <10ppm|Exhaled CO <10 ppm and no tobacco use in the past 7 days|28 days post quit date||||Participants|||Count of Participants
2617425|NCT01979952|Secondary|6MWT Total Distance Walked Change From Baseline at 6 Months|"Change in total distance covered in 6-minute walk test (6MWT) from baseline at 6 month is presented.~The 6-Minutes Walk Test (6-MWT) was conducted according to the American Thoracic Society (ATS) Criteria."|Baseline and 6 Months|TS (Only patients with observed cases (OC) values were analysed)|||meters||Standard Error|Least Squares Mean
2617410|NCT01980342|Secondary|Cervical Mucus Quality|Cervical mucus quality will be assessed twice weekly throughout the study period. The etonogestrel implant exerts a secondary contraceptive effect by causing cervical mucus to become thick and sticky, and therefore less permissive to the movement of sperm through the female genital tract. We will assess whether efavirenz causes a change in cervical mucus quality that would make sperm penetration more likely, and therefore indicate a reduction in the implant's contraceptive effect.|6 weeks|No data was collected for this outcome measure as the study was terminated prematurely after enrolling only 1 participant.||||||
2617411|NCT01980342|Secondary|Transvaginal Ultrasound to Assess for Ovarian Follicular Development|For the entire 6 week period of the study, participants will undergo twice-weekly transvaginal ultrasound to assess for the development of ovarian follicles. This direct assessment of follicular development will be combined with serum hormone concentrations to determine if efavirenz increases the incidence of ovulation in women using the etonogestrel implant for contraception.|6 weeks|No data was collected for this outcome measure as the study was terminated prematurely after enrolling only 1 participant.||||||
2617412|NCT01980342|Secondary|Serum Hormone Markers of Ovulation|We will test serial blood samples for levels of luteinizing hormone (LH), follicle stimulating hormone (FSH), estradiol, and progesterone to determine whether the etonogestrel implant is able to suppress ovulation during and after a course of efavirenz.|6 weeks|No data was collected for this outcome measure as the study was terminated prematurely after enrolling only 1 participant.||||||
2617413|NCT01980342|Secondary|Serum Efavirenz Concentrations at the Start and End of the 2-week Dosing Period|We will assess serum efavirenz concentrations at the beginning and end of the 2-week dosing period. By comparing these concentrations to historical controls, we will determine whether taking efavirenz while using the etonogestrel implant alters the serum concentration of efavirenz.|2 weeks|No data was collected for this outcome measure as the study was terminated prematurely after enrolling only 1 participant.||||||
2617414|NCT01980342|Primary|Serum Concentration of Etonogestrel Before and After Two Weeks of Efavirenz|We will draw a baseline serum etonogestrel immediately prior to a participant starting the 2-week course of efavirenz. Serial blood samples will subsequently be drawn over the next 6 weeks to assess for changes in serum etonogestrel concentration. We will be looking to see if the serum etonogestrel concentration decreases below the level necessary for reliable ovulation suppression.|6 weeks|No data was collected for this outcome measure as the study was terminated prematurely after enrolling only 1 participant.||||||
2617415|NCT01980095|Other Pre-specified|H. Pylori Eradication|The occurrence of H. pylori eradication in Placebo and Active Drug Eradication Failure Patients treated with Standard of Care (SOC) treatment|28-56 days after completion of SOC treatment|Eradication Failure Subjects at Visit 4 were treated with standard of care therapy by the investigator and performed a 13C Urea Breath Test at Visit 8 to confirm H. pylori eradication. This population included 27 subjects in the placebo group and 4 subjects in the active drug eradication failure subjects.|||Participants|||Count of Participants
2617416|NCT01980095|Primary|The Occurrence of H. Pylori Eradication as Confirmed Via 13C UBT Testing|Modified intent-to-treat (mITT) population analyzed included all participants whok received at least 1 dose of study drug and underwent a 13C Urea Breath Test (UBT) at Visit 4. Participants with negative test results were to be considered treatment successes. Patients who tested positive for H. pylori infection, and those with indeterminate, not assessable, or missing results were to be considered treatment failures. The statistical hypothesis that the active treatment is superior to 70% was to be tested against the alternative hypothesis that the active treatment is statistically indistinguishable or less than 70% effective using a one-sample Z-test.|28-56 days after completion of treatment|The mITT Population included all subjects who received at least 1 dose of randomized study treatment and underwent a 13C UBT test at Visit 4. This population consisted in 66 subjects in the RHB-105 group and 37 subjects in the placebo group.|||Participants|||Count of Participants
2617417|NCT01980056|Secondary|Number of Transfusions Required During Treatment With Vosaroxin|Characterize the blood product transfusion requirements in this patient population when treated with vosaroxin|15 months||||Transfusions||Full Range|Mean
2617418|NCT01980056|Secondary|Number of Subjects Who Experience a Response|Evaluate the clinical activity of vosaroxin in MDS subjects by observing number of patients who achieve complete remission.|15 months||||Participants|||Count of Participants
2617419|NCT01980056|Primary|Dosage Determination for IV-infusion of Vosaroxin in Int-2 or High-risk Mds|Maximum tolerated dose of vosaroxin for short IV infusion in INT-2 or high-risk MDS|1 year|All participants who received at least one dose of Vosaroxin were assessed for DLT in the first cycle of therapy. For this study. MTD is defined as the highest dose level at which no more than 33% of the patients observed at a given dose level experience a DLT.|||mg/m^2|||Number
2617420|NCT01979952|Secondary|Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbations at 6 Months|Percentage of subjects experienced first acute IPF exacerbations (based on Investigator reported adverse events) between 0 to 6 months are presented.|6 Months|TS|||Percentage of participants|||Number
2617421|NCT01979952|Secondary|Respiratory Mortality at 6 Months|Percentage of subjects who died due to respiratory cause between 0 to 6 months are presented.|6 Months|TS|||Percentage of participants|||Number
2617422|NCT01979952|Secondary|Respiratory Hospitalizations at 6 Months|Percentage of subjects hospitalized due to respiratory problems between 0 to 6 months are presented.|6 Months|TS|||Percentage of participants|||Number
2617423|NCT01979952|Secondary|All-cause Mortality at 6 Months|Percentage of subjects died from all causes between 0 to 6 months are presented.|6 Months|TS|||Percentage of participants|||Number
2617424|NCT01979952|Secondary|University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) Change From Baseline at 6 Months|"University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) change from baseline at 6 months is presented. Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at month 6)."|Baseline and 6 Months|TS (Only patients with observed cases (OC) values were analysed)|||Units on a scale||Standard Error|Least Squares Mean
2617426|NCT01979952|Secondary|St. George's Respiratory Questionnaire (SGRQ) Total Score Change From Baseline at 6 Months|"SGRQ total score change from baseline at 6 months is presented. SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact.~The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.~Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at month 6)."|Baseline and 6 Months|TS (Only patients with observed cases (OC) values were analysed)|||Units on a scale||Standard Error|Least Squares Mean
2617427|NCT01979952|Secondary|Categorical Change in FVC From Baseline at 6 Months|Percentage of participants reporting categorical change in FVC from baseline at 6 months are presented.|Baseline and 6 Months|TS (Only patients with observed cases (OC) values were analysed)|||Percentage of participants|||Number
2617428|NCT01979952|Secondary|Relative Change in FVC From Baseline at 6 Months|Relative change in FVC from baseline at 6 months is presented.|Baseline and 6 Months|TS (Only patients with observed cases (OC) values were analysed)|||percentage of change||Standard Error|Least Squares Mean
2617429|NCT01979952|Secondary|Absolute Change in Forced Vital Capacity (FVC) From Baseline at 6 Months|Absolute change in Forced Vital Capacity (FVC) from baseline at 6 months is presented.|Baseline and 6 Months|Treated Set (TS) (Only patients with observed cases (OC) values were analysed)|||milliliter (mL)||Standard Error|Least Squares Mean
2617430|NCT01979952|Secondary|Effect of Six Month Delayed Treatment Onset: Relative Change From Baseline in HRCT QLF Score at 12 Months|"Relative change from baseline in HRCT QLF score at 12 months was calculated as the ratio of the QLF score at 12 months to baseline. Greater values of the QLF score represented a worse health status and hence smaller relative changes from baseline (i.e., ratios) were considered favorable.~HCRT assessment obtained during screening visit was considered as baseline. Note that due to the change in study design, patients randomized to the placebo group were treated with nintedanib after completion of the first 6-month treatment period. Therefore, this new endpoint was defined to address the effect of a 6-month delayed onset of nintedanib treatment."|Baseline and 12 Months|Observed Cases (12 months) (OC12): The OC12 consisted of all patients in OC6 with observed QLF data at 12 months.|||percent change||Standard Error|Least Squares Mean
2617431|NCT01979952|Primary|Relative Change From Baseline in High Resolution Computerized Tomography (HRCT) Quantitative Lung Fibrosis (QLF) Score at 6 Months|Relative change from baseline in HRCT QLF score at 6 months was calculated as the difference of the QLF score at month 6 minus the QLF score at baseline divided by the baseline QLF score. The QLF score itself ranges from 0 to 100%, where greater values represent a greater amount of lung fibrosis and are considered a worse health status. Hence smaller relative changes from baseline (i.e., ratios) were considered favorable. HCRT assessment obtained during screening visit was considered as baseline.|Baseline and 6 Months|Observed Cases (6 months) (OC6): The OC6 consisted of all patients in the TS (all patients who were randomized to a treatment group and received at least 1 dose of study drug) with observed data for the primary endpoint (relative change from baseline in HRCT QLF score at 6 months).|||percent change||Standard Error|Least Squares Mean
2617432|NCT01979835|Secondary|Complications|Number of participants with complications and removals at the end of the 5-year follow-up period|5 years||||Participants|||Count of Participants
2617433|NCT01979835|Primary|Serosal-anchor Measurement|endovaginal ultrasound measurement of the distance from the anchor of the device and the serosal surface of the uterus|6-8 weeks||||mm||Standard Deviation|Mean
2617434|NCT01979614|Secondary|Systemic Clearance of Serelaxin|Systemic clearance was estimated using the rate of serelaxin infusion and the steady state concentration|From pre-dose on Day 1 until 48h after the start of drug infusion|"Pharmacokinetic Analysis Set~The PK analysis set includes all participants with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data"|||mL/hr/kg||Standard Deviation|Mean
2617435|NCT01979614|Secondary|Serum Concentration of Antibodies to Serelaxin|"Frequency and percentage of anti-Serelaxin antibodies~Blood samples were taken to measure antibodies to serelaxin concentration at Pre-dose on Day 1, and at Day 30 after the start of the 48h drug infusion"|From pre-dose on Day 1 until Day 30 after the start of drug infusion|Safety Analysis Set|||percentage of participants|||Number
2617436|NCT01979614|Secondary|Serum Concentration of Serelaxin|"Summary statistics of serelaxin serum PK concentrations~Blood samples were taken to measure serelaxin concentration"|Day1, Day 2, Day 3 and Day 30 after the start of infusion|"Pharmacokinetic Analysis Set~The PK analysis set includes all participants with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug and experienced no protocol deviations with relevant impact on PK data"|||pg/mL||Standard Deviation|Mean
2617437|NCT01979614|Secondary|Change From Baseline in Pulse Wave Velocity Measured From Carotid-femoral Pulse Wave Analysis|Pulse wave velocity was assessed by the SphygmoCor device|Day1, Day 2, Day 3, Day 30 and Day 180 after the start of infusion|The Pharmacodynamic (PD) analysis set included all patients with available PD data who received any study drug and experienced no protocol deviations with relevant impact on PD data. Any patients who had a reduced flow rate of infusion were excluded from this analysis|||meters/second||Standard Deviation|Mean
2617438|NCT01979614|Secondary|Statistical Analysis of Change From Baseline in Augmentation Index Using Repeated Measures Analysis of Covariance|"The change from baseline in Augmentation Index was analyzed using a repeated measures analysis of covariance including treatment, time, treatment by time, baseline by time interactions and baseline as fixed factors with an unstructured variance-covariance matrixStatistical analysis of change from baseline in augmentation index using repeated measures Analysis of Covariance~For analysis of change from baseline, only subjects with results at both baseline and post-baseline could be included~The augmentation index is a ratio calculated from the blood pressure waveform, it is a measure of wave reflection and arterial stiffness. Augmentation index is commonly accepted as a measure of the enhancement (augmentation) of central aortic pressure by a reflected pulse wave"|Day1, Day 2, Day 3, Day 30 and Day 180 after the start of infusion|PD Analysis Set|||ratio||95% Confidence Interval|Mean
2617609|NCT01977794|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP) After 18 Weeks of Treatment|Baseline was defined as the latest DBP before study treatment administration.|Baseline, Week 18|MITT analysis set was defined as all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP. Here “Number of subjects analyzed” signifies those subjects who were evaluable for this outcome measure.|||mmHg||Standard Deviation|Mean
2617439|NCT01979614|Secondary|Change From Baseline in Augmentation Index Measured From Sphygmocor Device|"Summary of values and change from baseline in augmentation index by time and treatment~The change from baseline in Augmentation Index was analyzed using a repeated measures analysis of covariance including treatment, time, treatment by time, baseline by time interactions and baseline as fixed factors with an unstructured variance-covariance matrixStatistical analysis of change from baseline in augmentation index using repeated measures Analysis of Covariance"|Day1, Day 2, Day 3, Day 30 and Day 180 after the start of infusion|PD Analysis Set For analysis of change from baseline, only subjects with results at both baseline and post-baseline could be included|||ratio||Standard Deviation|Mean
2617440|NCT01979614|Secondary|Change From Baseline in Aortic Velocity|"Summary table for measurements of arterial velocity from cardiac MRI - Mean (SD) [n]~Aortic distensibility was assessed by MRI and pulse wave velocity using the SphygmoCor device"|At pre-dose on Day 1 (baseline) until Day 180 after the start of drug infusion|PD Analysis Set|||cm/s||Standard Deviation|Mean
2617441|NCT01979614|Secondary|Change From Baseline in Aortic Distensibility Measured by MRI|"Measurements of arterial stiffness from cardiac MRI - Mean (SD) [n]~Aortic distensibility was assessed by MRI and pulse wave velocity using the SphygmoCor device.~(mmHg-1)"|At pre-dose on Day 1 (baseline) until Day 180 after the start of drug infusion|PD Analysis Set|||mmHg-1||Standard Deviation|Mean
2617442|NCT01979614|Primary|Statistical Analysis of Change From Baseline to Day 3 in Myocardial Perfusion Endpoints Compared With Mid Perfusion Reserve Index Using ANCOVA End Points|Global MPRI (Myocardial Perfusion Reserve Index) is defined as ratio between mean global myocardial blood flow values at rest and during adenosine stress with Mid Perfusion Reserve Index or Midl PRI (Mid Perfusion Reserve Index) which is defined as ratio between mid myocardial blood flow values at rest and during adenosine stress|baseline to Day 3|"The Pharmacodynamic (PD) analysis set included all patients with available PD data who received any study drug and experienced no protocol deviations with relevant impact on PD data.~Participants who did not receive study drug as per study protocol, i.e. a reduced infusion rate, were excluded from this analysis"|||ratio||95% Confidence Interval|Mean
2617443|NCT01979523|Other Pre-specified|Gnaq/11 Mutational Status|Clinical response will be associated with Gnaq/11 mutational status using Wilcoxon rank sum test.|Up to 4 weeks from last treatment|Analysis across the sample set unable to be completed due to patient-specific issues (participants skipped biopsy for safety, insufficient cores for extra DNA extraction)||||||
2617444|NCT01979523|Other Pre-specified|Circulating Tumor DNA Levels|The numeric data will be summarized by clinical response.|Up to 4 weeks from last treatment|Data were not analyzed due to lack of funding.||||||
2617445|NCT01979523|Other Pre-specified|Change in Suppression of Phosphorylated (p)-ERK, AKT, and Cyclin-D1|Association between suppression and response to treatment will be assessed using Fisher's exact test.|Baseline to 4 weeks from last treatment|The size of the cores from the acquired samples in almost all participants were small and the quality was insufficient to analyze across the sample set.||||||
2617446|NCT01979523|Other Pre-specified|Change in Apoptosis in Paired Samples as Assessed by Caspase 3 Cleavage||Baseline to 4 weeks from last treatment|The size of the cores from the acquired samples in almost all participants were small and the quality was insufficient to analyze across the sample set.||||||
2617447|NCT01979523|Secondary|Response Rate (Complete Response+ Partial Response) Using the RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.|From date of randomization until the date of death from any cause or 4 weeks from last treatment of the initial treatment assignment, whichever came first, assessed up to 12 months|This assessment corresponds to the participants' initial treatment assignment.|||participants|||Number
2617448|NCT01979523|Secondary|Overall Survival (OS) Per RECIST Criteria|OS curves will be generated using Kaplan-Meier methodology.|up to 36 months|This assessment corresponds to the participants' initial treatment assignment.|||weeks||Full Range|Median
2617449|NCT01979523|Secondary|Number of Participants With Toxicity, Graded According to the National Cancer Institute CTCAE v4.0, Who Were Treated and Did Not Withdraw Consent|Graded according to the National Cancer Institute CTCAE v4.0. Please see AE/SAE Section for specifics.|From date of randomization until the date of death from any cause or 4 weeks from last treatment of the initial treatment assignment, whichever came first, assessed up to 12 months|This assessment corresponds to the participants' initial treatment assignment.|||Participants|||Count of Participants
2617450|NCT01979523|Primary|Time to Progression (Progression-free Survival [PFS]), Defined From the Date of Randomization to the Date of Documented Progression or Death Per RECIST|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|from randomization to the earlier date of objective disease progression or death|This assessment corresponds to the participants' initial treatment assignment.|||weeks||Full Range|Median
2617451|NCT01979445|Secondary|Bleeding Events In Accordance With GUSTO Scale|"Bleeding was assessed by history, physical exam, and complete blood count (CBC) that was performed on study Day 1. Reports of bleeding were to be evaluated by performance of a CBC. Participants were assessed for bleeding events in accordance with the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) scale.~The severity of bleeding events by GUSTO Criteria is defined as the following:~Severe/life-threatening: fatal, intracranial hemorrhage, or if hemodynamic compromise results~Moderate: transfusion required~Mild: no transfusion or hemodynamic compromise~A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Screening through the follow-up period (5 to 7 days after Day 1)|Safety Population included all participants who received at least 1 dose of study drug.|||bleeding events|||Number
2617855|NCT01975701|Secondary|Overall Survival|To further assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes that harbor FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 and 3 based on Overall Survival|5 years|full analysis set|||months||95% Confidence Interval|Median
2617452|NCT01979445|Secondary|Extent of Preservation of Platelet Inhibitory Effect of Cangrelor Treatment After Prasugrel or Clopidogrel Compared to Treatment With Cangrelor Alone Determined By VerifyNow P2Y12 Assay|A reference point for cangrelor was chosen for comparison and designated as the administration time of prasugrel 60 mg or clopidogrel 600 mg (2.5, 2, 1.5, or 1 hrs). Platelet function was assessed using the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was assessed by PRU, determined by the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay is designed to directly measure the effects of drugs on the P2Y12 receptor, using prostaglandin E1 in addition to ADP to increase intraplatelet cAMP. Platelet reactivity was expressed in PRU.|Day 1 at 1, 1.5, 2, or 2.5 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 1.75 and 2 hrs after initiation of cangrelor infusion|Participants treated with cangrelor and prasugrel or clopidogrel were used for the analysis and presentation of data.|||PRU||Standard Deviation|Mean
2617453|NCT01979445|Secondary|Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor to Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone Determined By VerifyNow P2Y12 Assay|A reference point for prasugrel or clopidogrel was chosen for comparison and designated at 6 or 5.5 hrs after the administration of prasugrel or clopidogrel as the reference for the effect of the oral drug. Platelet function was assessed using the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was assessed by platelet reaction units (PRU), determined by the VerifyNow P2Y12 assay. The VerifyNow P2Y12 assay is designed to directly measure the effects of drugs on the P2Y12 receptor, using prostaglandin E1 in addition to ADP to increase intraplatelet cyclic adenosine monophosphate (cAMP). Platelet reactivity was expressed in PRU.|Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusion|Participants treated with cangrelor and prasugrel or clopidogrel were used for the analysis and presentation of data.|||PRU||Standard Deviation|Mean
2617454|NCT01979445|Primary|Extent Of Preservation Of Platelet Inhibitory Effect Of Cangrelor Treatment After Prasugrel Or Clopidogrel Compared To Treatment With Cangrelor Alone|A reference point for cangrelor was chosen for comparison and designated as the administration time of prasugrel 60 mg or clopidogrel 600 mg (2.5, 2, 1.5, or 1 hrs). Platelet function was assessed using LTA. LTA measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was examined using LTA and expressed as % aggregation in response to 20 μM ADP at 300 sec (final/terminal aggregation response).|Day 1 at 1, 1.5, 2, or 2.5 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 1.75 and 2 hrs after initiation of cangrelor infusion|Participants treated with cangrelor and prasugrel or clopidogrel were used for the analysis and presentation of data.|||% aggregation||Standard Deviation|Mean
2617455|NCT01979445|Primary|Extent of Preservation Of Platelet Inhibitory Effect After Transition From Cangrelor To Prasugrel Or Clopidogrel Compared With Effect Observed With Prasugrel Or Clopidogrel Alone|A reference point for prasugrel or clopidogrel was chosen for comparison and designated at 6 or 5.5 hrs after the administration of prasugrel or clopidogrel as the reference for the effect of the oral drug. Platelet function was assessed using light transmittance aggregometry (LTA). LTA measures the aggregation or cross linking of platelets by fibrinogen and requires the activation of platelets plus the binding of fibrinogen. The extent of aggregation was expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (sec) (final/terminal aggregation response).|Day 1 at 5.5 or 6 hrs after administration of prasugrel or clopidogrel (reference) and Day 1 at 2.25, 2.5, 2.75, 3, 4, and 5.5 hrs after initiation of cangrelor infusion|Participants treated with cangrelor and prasugrel or clopidogrel were used for the analysis and presentation of data.|||% aggregation||Standard Deviation|Mean
2617456|NCT01979276|Secondary|Time to Disease Progression (Progression Free Survival)||From start of treatment, to date of disease progression (on average, ten 28-day cycles)||||cycles (defined as 28 days)||Full Range|Mean
2617457|NCT01979276|Primary|Efficacy of Study Regimen Combination|The efficacy (as assessed by clinical response) of the combination of pomalidomide (CC-4047®) and romidepsin as therapy for patients with relapsed or refractory multiple myeloma (MM) (phase II portion) was evaluated using the IMWG Response Criteria for disease assessment. The best response was reported. (Criteria can be found at the following link, due to length and complexity of the response criteria: http://imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/)|From baseline to cycle of maximum response, which occurred on average after 2 cycles; 1 cycle = 28 days||||Participants|||Count of Participants
2617458|NCT01979276|Primary|Maximum Tolerated Dose (MTD) of Romidepsin in Combination With Pomalidomide and Dexamethasone|Establish a maximum tolerated dose (MTD) of romidepsin in combination with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma (phase I)|During the duration of the study (from first to last dose of study drug, on average ten 28-day cycles)|MTD not established as study terminated while only 2 subjects enrolled. Only romidepsin dose tested was 9mg/mg2||||||
2617459|NCT01979185|Primary|Maximum Plasma Concentration (Cmax) of Simvastatin|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng/mL||Standard Deviation|Mean
2617460|NCT01979185|Primary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Simvastatin|AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*h/ml||Standard Deviation|Mean
2617861|NCT01975675|Primary|Percentage of Participants With Sustained Virologic Response at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set|||percentage of participants|||Number
2617461|NCT01979185|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) for Simvastatin|AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last nonzero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 72 hours post-dose|Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*h/ml||Standard Deviation|Mean
2617462|NCT01979159|Secondary|Changes in Speech Intelligibility on the Assessment of Intelligibility of Dysarthric Speech|Speech intelligibility (understandability of speech) was measured by having participants produce 50 words from the Assessment of Intelligibility of Dysarthric Speech (ASSIDS) Two speech-language (blinded) scored pre and post treatment ASSIDS samples. The percentage of words correctly understood was calculated for each participant. The ASSIDS is not a scale - it is a procedure for calculating intelligibility. Speech intelligibility can range from 0% to 100% intelligible (no words understood to all words understood). The higher the percentage, the better the speech is understood by the listener. Change in percent words intelligible has the potential to be a negative (reflecting a poor outcome of less intelligible speech) or positive (reflecting a good outcome of more intelligible speech). The maximum possible amount of gain in intelligibility for these 4 participants, based on their pretreatment performance, ranged from +2% to +25%.|pre and post treatment - prior to the start of treatment and at 6 weeks following the completion of treatment|Change in percent of words that were intelligible|||percentage of change-intelligible words||Full Range|Mean
2617463|NCT01979159|Primary|Change in Production of Language Content for Untreated Sets - Generalization Measured in Effect Sizes|Correct Information Units (CIUs) is a measure of the amount of relevant content produced in connected language tallied according to operationalized criteria. CIU is not a test or scale - it is a measure that is applied to language samples - in this case, description of untreated pictures. Participants described experimental pictures, responses were transcribed and CIUs counted. CIUs can range from 0 to an unlimited maximum. Effect sizes (ESs) were calculated as an indication of the magnitude of change in number of CIUs produced (pre treatment to post treatment. ESs can range from negative (poorer performance post-treatment) to positive values (better performance post-treatment), with larger positive values reflecting greater gains. Benchmarks are as follows: >9.53 = large, 9.52 - 5.52 = medium, 6.55 - 3.29 = small, <3.29 = negligible. Small to large ESs indicate production of measurably more CIUs in picture descriptions post-treatment. Larger the ES, the greater the change.|baseline (prior to treatment) through follow-up at 6 weeks post treatment|One participant received treatment on all sets; consequently, generalization to an untreated set could not be calculated|||units on a scale||Full Range|Mean
2617464|NCT01979159|Primary|Change in Language Content Production for Treated Stimuli: Effect Sizes (Magnitude of Change From Baseline to Follow-up)|Correct Information Units (CIUs) is a measure of the amount of relevant content produced in connected language tallied according to operationalized criteria. CIU is not a test or scale - it is a measure that is applied to language samples - in this case, description of treated pictures. Participants described experimental pictures, responses were transcribed and CIUs counted. CIUs can range from 0 to an unlimited maximum. Effect sizes (ESs) were calculated as an indication of the magnitude of change in number of CIUs produced (pre treatment to post treatment. ESs can range from negative (poorer performance post-treatment) to positive values (better performance post-treatment), with larger positive values reflecting greater gains. Benchmarks are as follows: >11.14 = large, 11.13 - 6.56 = medium, 6.55 - 3.88 = small, <3.88 = negligible. Small to large ESs indicate production of measurably more CIUs in picture descriptions post-treatment. Larger the ES, the greater the change.|Following completion of treatment at 6 weeks post||||units on a scale||Full Range|Mean
2617465|NCT01979133|Primary|Change in Young Mania Rating Scale (YMRS) From Baseline to Week 8 (Exit)|"The YMRS is an 11-item observer-rated measure of mania symptomatology:~7 individual items are scored between 0-4.~4 individual items are scored between 0-8.~Total score range is 0-60, with no subscales. Higher score is indicative of more manic symptoms. Lower score represents better outcomes.~Total score is obtained by adding items on the scale together."|Baseline vs. Week 8 (Exit)|The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.|||YMRS units on a scale||Standard Deviation|Mean
2617466|NCT01979133|Primary|Change in Days of Alcohol Use From Baseline to Week 8 (Exit)|"Total score range is 0-7 (no days of alcohol use - 7 days of alcohol use). The lower score represents better outcome.~Participants are asked to identify days on which they used alcohol in the past week (not including the day of visit)."|Baseline vs. Week 8 (Exit)|The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.|||Days Per Week||Standard Deviation|Mean
2617467|NCT01979133|Primary|Change in Number of Heavy Drinking Days From Baseline to Week 8 (Exit)|"Heavy drinking day is defined as 5 standard drinks per day for men, and 4 standard drinks per day for women.~Minimum score is 0 (no drinks); maximum score is unique to each individual participant. Lower score represents a better outcome.~Average number of heavy drinking days per week is calculated by asking participants to identify the number of drinks they had on each day during the past 7 days (not including the day of visit).~See outcome measure description for standard drinks per week for standard drinks convention."|Baseline vs. Week 8 (Exit)|The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.|||Days Per Week||Standard Deviation|Mean
2617497|NCT01978912|Other Pre-specified|Changes in Lower Back Pain or Leg Pain Assessed by 11-point Numerical Rating Scale|"Lower back and leg pain were assessed using an 11-point numerical rating scale (0 = no pain and 10 = worst possible pain).~The endpoint was mean change from baseline at 6 and 13 weeks post-dose; with a negative number suggesting an improvement in pain while a positive number suggests a worsening in pain."|Baseline, 6 weeks and 13 weeks post-dose|The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.|||score on a scale||Standard Deviation|Mean
2617468|NCT01979133|Primary|Change in Number of Standard Drinks of Alcohol Per Week Baseline vs. Week 8 (Exit)|"Participants are asked to identify the number of alcoholic drinks they consumed on each day within the last 7 days from the day of visit (not including the day of visit). Participants are asked to provide alcohol name and the amount of alcohol they consumed. These values are then converted to standard drinks using a standard drinks calculator.~The minimum number of drinks per week is 0. There is no maximum number of drinks per week, as the maximum number is unique to each participant.~The general convention for standard drinks used in this study is as follows (oz per one standard drink):~beer: 12 fl oz (5% ABV)~wine: 5 fl oz (10-12% ABV or 18-20% ABV for fortified wine)~hard liquor: 1.5 fl oz (40% ABV)"|Baseline vs. Week 8 (Exit)|The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.|||Drinks per week||Standard Deviation|Mean
2617469|NCT01979133|Primary|Change in Quick Inventory of Depressive Symptomatology (QIDS) Score From Baseline to Week 8|"The QIDS is a 16-item self-report measure of depressive symptomatology:~16 items rated on a scale from 0-3. No subscales for this instrument.~Total score range is 0-27, where higher score represents higher levels of depression. Lower scores associated with better outcomes.~Total score is obtained using the following formula: highest score on items 1-4 + item 5 + highest score on items 6-9 + item 10+item 11+item12+item13+item14+highest score on items 15-16"|Baseline vs. Week 8 (Exit)|The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a result, the overall number of participants included in the analysis was 9.|||QIDS units on a scale||Standard Deviation|Mean
2617470|NCT01979133|Primary|Change in Hamilton Rating Scale of Anxiety From Baseline to Week 8 (Exit)|"HAMA is a 14-item observer rated measure of anxiety symptomatology:~14 items in a scale, no subscales. Individual items are score 0 (no anxiety) to 4 (very severe anxiety).~Total scores range from 0-56.~Total scores represent more severe anxiety. Lower scores represent a better outcome."|Baseline vs. Week 8 (Exit)|The planned enrollment was 10 participants. One participant dropped out during Baseline II visit, thus researchers were unable to assess change from baseline to week 8 in this participant. As a results, the overall number of participants analyzed was 9.|||HAMA units on a scale||Standard Deviation|Mean
2617471|NCT01979133|Primary|Change in Hamilton Rating Scale of Depression (HAMD) From Baseline to Week 8 (Exit)|"HAMD is an observer-rated measure of depressive symptomatology:~17 questions (answers for individual questions range between 0-3 and 0-4). Total score range: 0-52. No subscales for this measure.~0 - no depression; 52 - very severe depression (lower score corresponds to a better outcome).~Total score is obtained by summing questions 1-17."|Baseline vs. Week 8 (Exit)|The total enrollment goal was 10. One participant dropped out during the baseline II visit, thus week 8 score was not obtained for that participant and the change from baseline to week 8 could not be collected. Thus, the analysis includes 9 participants instead of proposed 10.|||HAMD scale units||Standard Deviation|Mean
2617472|NCT01979029|Other Pre-specified|Systemic Blood Pressure||after ligating the inferior mesentric artery and measuring the blood pressure of the marginal artery of distal colon||||mmHg||Standard Deviation|Mean
2617473|NCT01979029|Secondary|Distal Colon Length||after digestive tract reconstruction||||cm||Standard Deviation|Mean
2617474|NCT01979029|Primary|The Blood Pressure of the Arterial Arcade||after ligating the inferior mesentric artery or superior rectal artery||||mmHg||Standard Deviation|Mean
2617475|NCT01979016|Secondary|Changes From Baseline in GISS Cumulative Score to Week 16|Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).Values after first rescue medication use were set to missing and missing values were imputed by LOCF.|Baseline to Week 16|FAS population was used.|||units on a scale||Standard Error|Least Squares Mean
2617476|NCT01979016|Secondary|Change From Baseline in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) to Week 16|Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none, 1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).Values after first rescue medication use were set to missing and missing values were imputed by LOCF.|Baseline to Week 16|FAS population was used.|||units on a scale||Standard Error|Least Squares Mean
2617477|NCT01979016|Secondary|Percent Change From Baseline in Participant's Oriented Eczema Measure (POEM) Score to Week 16|POEM was a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.|Baseline to Week 16|FAS population was used.|||percent change||Standard Error|Least Squares Mean
2617478|NCT01979016|Secondary|Absolute Change From Baseline in Participant's Oriented Eczema Measure (POEM) Score to Week 16|POEM was a 7-item questionnaire that assessed disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.|Baseline to Week 16|FAS population was used.|||units on a scale||Standard Error|Least Squares Mean
2617488|NCT01979016|Primary|Percent Change From Baseline in the Eczema Area Severity Index Score (EASI) to Week 16|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Values after first rescue medication use were set to missing and missing values imputed by last observation carried forward (LOCF).|Baseline to Week 16|Full analysis set (FAS) population that included all participants who were randomized into this study and received at least 1 dose of study drug.|||percent change||Standard Error|Least Squares Mean
2617479|NCT01979016|Secondary|Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in SCORAD Score (SCORAD-50, SCORAD-75 and SCORAD-90 Respectively) at Week 16|SCORAD was a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). SCORAD-50, SCORAD-75 and SCORAD-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% respectively, overall improvement in SCORAD score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing SCORAD score at Week 16 were counted as non-responders.|Baseline to Week 16|FAS population was used.|||percentage of participants|||Number
2617480|NCT01979016|Secondary|Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in EASI Score ( EASI-50, EASI-75, and EASI-90 Respectively) at Week 16|EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranged from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50, EASI-75 and EASI-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% respectively, overall improvement in EASI score from baseline to Week 16. Values after first rescue treatment were set to missing and participants with missing EASI score at Week 16 were counted as non-responders.|Baseline to Week 16|FAS population was used.|||percentage of participants|||Number
2617481|NCT01979016|Secondary|Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score to Week 16|SCORAD is a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.|Baseline to Week 16|FAS Population was used.|||percent change||Standard Error|Least Squares Mean
2617482|NCT01979016|Secondary|Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score to Week 16|SCORAD was a clinical tool for assessing the severity of atopic dermatitis developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) were assessed and scored. Total score ranged from 0 (absent disease) to 103 (severe disease). Values after first rescue medication use were set to missing and missing values were imputed by LOCF.|Baseline to Week 16|FAS population was used.|||units on a scale||Standard Error|Least Squares Mean
2617483|NCT01979016|Secondary|Absolute Change From Baseline in EASI Score to Week 16|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Values after first rescue medication use were set to missing and missing values were imputed by LOCF.|Baseline to Week 16|FAS population was used.|||units on a scale||Standard Error|Least Squares Mean
2617484|NCT01979016|Secondary|Percent Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Values after first rescue treatment were set to missing and missing values were imputed by LOCF.|Baseline to Week 16|FAS population. Here, number of participants analyzed = participants with available data for this endpoint.|||percent change||Standard Error|Least Squares Mean
2617485|NCT01979016|Secondary|Absolute Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). Values after first rescue treatment were set to missing and missing values were imputed by LOCF.|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Error|Least Squares Mean
2617486|NCT01979016|Secondary|Percentage of Participants Who Achieved IGA Score Reduction From Baseline of ≥2 Points at Week 16|IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Participants with reduction in IGA score from baseline of ≥2 points at Week 16 were reported. Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as non-responders.|Baseline to Week 16|FAS population was used.|||percentage of participants|||Number
2617487|NCT01979016|Secondary|"Percentage of Participants With Investigator's Global Assessment (IGA) Score of 0 or 1 at Week 16"|IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were considered as non-responders.|Week 16|FAS population was used.|||percentage of participants|||Number
2617496|NCT01978912|Other Pre-specified|Number of Participants With Changes to Spinal Flexion and Tension Using the Straight-Leg Rising and/or Femoral Stretch Test|The changes to spinal flexion and tension were assessed using Straight-Leg Rising (SLR) and Femoral Stretch (FS) tests which are on a scale of no change, positive to negative or negative to positive and where a positive result for SLR may indicate between 30 and 70 degrees, where a positive result for FS may indicate pain in the anterior thigh of the test leg and the elicited pain.|Baseline, 6 weeks and 13 weeks post-dose||||Participants|||Count of Participants
2617489|NCT01978938|Secondary|Participants In The Microbiologically Evaluable (ME) Population With A Microbiological Response|This outcome measure (FDA and EMA) compared the microbiological responses of eravacycline to levofloxacin for both treatment groups in the ME population. Responses were either success or failure. Indeterminate/missing responses were not included. Success was considered a reduction of the baseline pathogen(s) to <10^4 CFU/mL. Failure required blood cultures at or beyond EOT to be positive for baseline pathogen(s), or urine culture to grow ≥10^4 CFU/mL of the baseline pathogen(s). Indeterminate/missing indicated no interpretable culture data available. Populations: ME, all micro-ITT and clinically-evaluable (CE) participants with a suitable urine specimen and an interpretable urine culture; micro-ITT, all participants with ≥1 baseline bacterial pathogen from a urine or blood culture that caused a UTI against which eravacycline had expected antibacterial activity; ITT, all randomized participants, regardless of receiving study drug or not.|PT Visit|ME: all micro-ITT and CE participants with a suitable urine specimen and an interpretable urine culture. CE: all randomized participants dosed with no other antimicrobials (unless allowed by protocol), had an investigator clinical response assessment of “success” or “failure” at the assessment visit, and had no other major protocol violations.|||Participants|||Count of Participants
2617490|NCT01978938|Secondary|Participants In The Microbiological Modified ITT (Micro-MITT) Population With A Microbiological Response|This outcome measure (FDA and the European Medicines Agency [EMA]) compared the microbiological responses of eravacycline to levofloxacin for both treatment groups in the micro-MITT population. Responses were success, failure, or indeterminate/missing. Success was considered a reduction of the baseline pathogen(s) to <10^4 CFU/mL. Failure required blood cultures at or beyond end of therapy (EOT) to be positive for baseline pathogen(s), or urine culture to grow ≥10^4 CFU/mL of the baseline pathogen(s). Indeterminate/missing indicated no interpretable culture data available.|PT Visit|micro-MITT included all micro-ITT participants who received ≥1 dose of study drug. micro-ITT: all ITT participants with ≥1 baseline bacterial pathogen from a urine or blood culture that caused a UTI against which eravacycline had expected antibacterial activity. ITT: all randomized participants, regardless of receiving study drug or not.|||Participants|||Count of Participants
2617491|NCT01978938|Primary|Participants In The Microbiological Intent-To-Treat (Micro-ITT) Population With A Responder Outcome At The Post-Treatment (PT) Visit|This was the primary outcome measure for the Food and Drug Administration (FDA). The primary objective was to demonstrate the non-inferiority (NI) of eravacycline to levofloxacin in responder outcome, which was derived from both clinical and microbiological responses, in the micro-ITT population. Clinical responses were either cure, failure, or indeterminate/missing; microbiological responses were characterized programmatically as either success, failure, or indeterminate/missing. Clinical cure was defined as complete resolution or significant improvement of signs or symptoms of the infection; microbiological success was a reduction of the baseline pathogen(s) to <10^4 colony-forming units/milliliter (CFU/mL). An outcome of Responder required a clinical response of cure and a microbiological response of success. Any other combination of the clinical and microbiological responses was considered either Non-responder or Indeterminate.|PT Visit|micro-ITT included all participants in the ITT population who had at least 1 baseline bacterial pathogen from a urine or blood culture that caused a urinary tract infection (UTI) against which eravacycline had expected antibacterial activity. ITT included all randomized participants, regardless of receiving study drug or not.|||Participants|||Count of Participants
2617492|NCT01978912|Other Pre-specified|Changes in Serum Concentrations of Keratan Sulfate|The endpoint was change from baseline at 6 and 24 hours post-dose, and at the 1-, 2-, 4-, 6-, and 13-week follow-up visits or early termination visit.|Baseline, 6 and 24 hours and 1, 2, 4, 6 weeks and 13 weeks post-dose|The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.|||ng/ml||Standard Deviation|Mean
2617493|NCT01978912|Other Pre-specified|Patient Global Impression of Change (PGI-C)|The Patient Global Impression Change PGI-C scale was used where the scale ranges are from 1 (no change or condition has got worse) to 7 (a great deal better, and a considerable improvement). The endpoint was the value at 6 and 13 weeks post-dose.|Baseline, 6 weeks and 13 weeks post-dose|The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.|||score on a scale||Standard Deviation|Mean
2617494|NCT01978912|Other Pre-specified|Changes in Quality of Life as Assessed by Short Form-12 (SF-12)|The endpoint was change from baseline at Week 6 and 13 hours post-dose. The Short Form-12 (SF-12) is a Quality of Life questionnaire which measures functional health and well-being from a participant's perspective across eight health domains. Each participant answers questions on a 5-point Likert scale, which rates responses according to how much the participant agrees or disagrees with a particular statement on their health and wellbeing, including vitality/physical functioning/bodily pain/general health perceptions/physical role functioning/emotional role functioning/social role functioning and mental health. Each scale is transformed into a 0-100 scale, assuming each question carries equal weight. Lower scores mean greater disability and higher scores mean less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Baseline, 6 weeks and 13 weeks post-dose|The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.|||score on a scale||Standard Deviation|Mean
2617495|NCT01978912|Other Pre-specified|Number of Participants With Changes in the Oswestry Disability Index|"The Oswestry Disability Index (ODI) score is calculated as participant score divided by possible score multiplied by 100, where the following scores can be interpreted to indicate:~0-20% = Minimal disability; 20-40% = Moderate disability; 40-60% = Severe disability; 60-80% = Crippled; 80-100% = Bed bound;"|Baseline, 6 weeks and 13 weeks post-dose|The Full Analysis Set (FAS) was used which consists of any subject who was enrolled into the study, received study drug, and had at least 1 efficacy evaluation after receiving study drug. In some cohorts, number of subjects are below 6 participants due to discontinuation and/or data missing.|||Participants|||Count of Participants
2617498|NCT01978912|Secondary|Number of Participants With Anti-KTP-001 Antibody||13 weeks||||Participants|||Count of Participants
2617501|NCT01978912|Primary|Safety Assessed by Adverse Events, Magnetic Resonance Imaging (MRI), X-ray Imaging, Physical Examination, Neurologic Examination and Vital Signs|"Any clinically significant changes were recorded as adverse events. They are described in the adverse events section of the results.~AEs related to MRI, X-ray Imaging, Physical examination, and Neurologic examination are considered as adverse events of special interest (AESI). A treatment-emergent AE (TEAE) was defined as an AE that was not present prior to treatment with study drug, but appeared following treatment or was present at treatment initiation but worsened in severity during treatment."|24 months||||Participants|||Count of Participants
2617502|NCT01978743|Secondary|Change in Level of EFV and Metabolites|Correlate change in level of EFV and metabolites with neurocognitive and neuroimaging changes|week 0 and week 8|Level of EFV (efavirenz) in Atripla and its two known metabolites known to cause cerebral side effects, 7-hydroxy (OH) EFV and 8-OH EFV, were measured in the plasma prior to switch off Atripla and after 8 weeks of RAL-based regimen (no EFV).|||participants|||Number
2617503|NCT01978743|Secondary|Markers of Immune Activation|Change in markers of immune activation and inflammation associated with change to RAL (ie, sCD14, IL-6, hsCRP, D-dimer, CRP, LPS, sCD163, EndoCab)|week 0 and week 8||||pg/ml||Standard Deviation|Mean
2617504|NCT01978743|Secondary|ART Regimen Preference|Evaluate patient preference in ART regimen (Atripla, EFV/FTC/TDF versus RAL + FTC/TDF) through self-administered questionnaires.|week 0 and week 8|Each participant was asked a single self-administered question on their ART preference and asked to chose one of the 3 answers; 1. prefer to take Atripla, 2. prefer RAL-based regimen (that they received in study) or 3. no preference.|||participants|||Number
2617505|NCT01978743|Secondary|Sleep Quality|Assess for changes in sleep pattern and quality prior to and after switching off EFV-based regimen through a self-administered Pittsburg Sleep Quality Index (PSQI). Measure consists of 19 items with each weighted on 0-3 scale and the sum produces a total score, which ranges from 0-21. The lower the score the healthier the sleep quality.|week 0 and week 8||||units on a scale||Standard Deviation|Mean
2617506|NCT01978743|Secondary|Fasting Lipid Profile|Measure the change in fasting lipid panel prior to and after switching off EFV-based regimen.|week 0 and week 8|Change in lipid panel pre- and post-switch to RAL-based regimen|||mg/dL||Standard Deviation|Mean
2617507|NCT01978743|Secondary|Neurocognitive Changes Measured by a Panel of Indexes: WAIS-R, HAMD, DASS-21, FRSBE, STAI|"Assess for changes in cognitive and affective function prior to and after switching off EFV-based regimen. Indexes used to access neurocognitive changes included:~Wechsler Adult Intelligence Scale (WAIS-R) Digital Symbol Substitution Test: sensitive to brain dmamage, dementia, age and depressive changes. Range of 0-100, the higher the score the better the person's performance~Hamilton Rating Scale for Depression (HAMD): Measure of depression. Score of 0-7 is normal, score of >20 is moderate/severe depression~Depression Anxiety Stress Scale (DASS-21) the lower the score, the less severe depression, anxiety and stress. Scale range of 0-63~Frontal Systems Behavior Scale (FRSBE): Increased score indicates greater behavioral impairment associated with frontal systems, range 37.2 to 186~Spielberger state trait anxiety inventory (STAI): the higher the score the greater then anxiety level, range of 20 to 80."|week 0 and week 8||||units on a scale||Standard Deviation|Mean
2617508|NCT01978743|Secondary|Other Neurometabolite Changes Measured by MRS|Use MRS to evaluate a fuller panel of known neurometabolites (in addition to the primary endpoints) to evaluate for prominent and significant changes associated with EFV use.|week 0 and week 8|The arbitrary units are expressed as the output from MRS software. While similar to concentration (mM) due to assumptions in the software, it is best expressed as arbitrary units for comparison from week 0 to week 8.|||arbitrary units||Standard Deviation|Mean
2617509|NCT01978743|Primary|Neural Activation Networks Using Functional Magnetic Resonance Imaging (fMRI)|Assess changes in neural activation correlated with affective disturbances associated with EFV vs. RAL using fMRI employing a paradigm that probes affective symptomatologies typical with EFV use; anxiety/dysphoria and affective dysregulation, and their association with changes in cognitive function. Four brain regions of interests (ROIs) are specified to show the differential frontal-limbic activation patterns in the task-evoked neural responses to the 3 linear contrasts of Pre-/Post-/ Pre-vs. Post-switch: [Negative Word vs. Neutral Word] x [No-Go Trial Block vs. Go Trial Block]: anterior Frontal Pole (aFP), posterior Cingulate Gyrus (pCG), dorsal anterior Cingulate Gyrus (daCG), Left Hippocampus (LHC). A linear mixed-effects model is utilized to examine the effect sizes of the key Regimen/Condition contrasts, with the Subject factor as the random-effect, and Age incorporated as a co-variate of no interest. A z-score is the Mean with a SD=1 and Measure of Dispersion equal to 1.|week 0 and week 8|8 of 10 enrolled patients passed QA testing to qualify for final fMRI data analyses. The 3 linear contrasts of Pre-switch/Post-switch/Pre- vs. Post-switch: [Neg vs.Neu] x [No-Go vs. Go] are reported as z-score (standardized effect size measures with SD=1). Z-score is obtained for each subject, group Z-score is obtained via a mixed-effects model.|||z-score|||Number
2617510|NCT01978743|Primary|Neurometabolites Based on Magnetic Resonance Spectroscopy (MRS)|Assess the levels of neuro-metabolites measured by MRS at week 0 before switching to the efavirenz-based therapy. Two areas of the brain: 1) posterior cingulate gyrus and 2) anterior cingulate will be assessed for the levels of brain creatine (Cr), gamma-aminobutyric acid (GABA) and glutathione (GLU).|week 0 and week 8|The arbitrary units are expressed as the output from MRS software. While similar to concentration (mM) due to assumptions in the software, it is best expressed as arbitrary units for comparison from week 0 to week 8.|||arbitrary units||Standard Deviation|Mean
2617511|NCT01978600|Secondary|Mean 24-hour IOP at Week 4|24-hour IOP (fluid pressure inside the eye) is the mean of all the time points assessed (8 AM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM|This analysis population includes all participants who received study medication and had at least one on-therapy study visit.|||mmHg||Standard Deviation|Mean
2617610|NCT01977794|Primary|Mean Reduction In Systolic Blood Pressure (SBP) After 18 Weeks of Treatment From Baseline|Baseline was defined as the latest SBP under monotherapy.|Baseline, Week 18|MITT analysis set was defined as all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP. Here “Number of subjects analyzed” signifies those subjects who were evaluable for this outcome measure.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2617512|NCT01978600|Secondary|Mean Diurnal IOP at Week 4|Diurnal IOP (fluid pressure inside the eye) is the mean of the diurnal time points assessed (8 AM to 8 PM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM|This analysis population includes all participants who received study medication and had at least one on-therapy study visit.|||mmHg||Standard Deviation|Mean
2617513|NCT01978600|Primary|Mean Nocturnal IOP at Week 4|Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 4: 10PM, 12AM, 2AM, 4AM, 6AM|This analysis population includes all participants who received study medication and had at least one on-therapy study visit.|||mmHg||Standard Deviation|Mean
2617514|NCT01978535|Primary|Cardiovascular Indices-interval Change in Heart Rate During 10-minute Head up Tilt Table Test|This study will assess whether a single infusion of iron sucrose will improve cardiovascular indices, specifically a reduction in the interval of measured heart rate change, during a ten minute head up tilt, in adolescent subjects with POTS and non-anemic iron deficiency|7 (+/- 2) days following intervention|The outcome measure was not analyzed because there were insufficient data.||||||
2617515|NCT01978314|Secondary|To Evaluate the Correlation Between FAST's Plasma Volume Method and Standard Clinical Estimates of Plasma Volume.|This analysis will compare estimates of plasma volume derived by FAST's plasma volume method with that derived using the conventional Nadler's Formula for plasma volume.|Baseline through day 22||||mL||Standard Deviation|Mean
2617516|NCT01978314|Secondary|To Compare the Results From the GFR Determined From the FAST VFI™ to GFR Derived From Iohexol Clearance Methods.|This analysis will compare estimates of kidney function derived from the results of FAST VFI™ to those derived through conventional Iohexol clearance methods.|Baseline through Day 22|The subject in Cohort 4 did not receive Iohexol. One subject in Cohort 5 withdrew from the study before receiving Iohexol. Samples were missing for 1 subject in each of Cohorts 1 and 3.|||mL/min||Standard Deviation|Mean
2617517|NCT01978314|Secondary|AUCinf/Dose of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|AUCinf/Dose = area under the concentration-time curve (time 0 extrapolated to infinity based on the last observed concentration)/Dose|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||[(ng∙hr/mL)/(mg/m^2)]||Standard Deviation|Mean
2617518|NCT01978314|Secondary|Cmax/Dose of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|Cmax/Dose = maximum observed concentration occurring at Tmax/Dose|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||[(ng/mL)/(mg/m^2)]||Standard Deviation|Mean
2617519|NCT01978314|Secondary|CL of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|CL = total body clearance|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||mL/hr/m^2||Standard Deviation|Mean
2617520|NCT01978314|Secondary|Vss of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|Vss = volume of distribution at steady state|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||mL/m^2||Standard Deviation|Mean
2617521|NCT01978314|Secondary|Vz of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|Vz = volume of distribution based upon terminal phase|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||mL/m^2||Standard Deviation|Mean
2617522|NCT01978314|Secondary|T1/2, z of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|T1/2 = terminal half-life = ln(2)/λz|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||hr||Standard Deviation|Mean
2617523|NCT01978314|Secondary|AUCinf of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|AUCinf = area under the concentration-time curve (time 0 extrapolated to infinity based on the last observed concentration)|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||ng∙hr/mL||Standard Deviation|Mean
2617856|NCT01975701|Secondary|Overall Response Rate|To further assess the anti-tumor activity of BGJ398 for patients with GBM with an amplification, translocation, or activating mutation in FGFR1,2,3 or 4, based on Objective Response Rate (ORR - patients with measurable disease - as defined by RANO criteria as assessed by the investigator|5 years|full analysis set|||Participants|||Count of Participants
2617524|NCT01978314|Secondary|AUCall of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|AUCall = area under the concentration-time curve (time 0 to last scheduled sample)|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||ng∙hr/mL||Standard Deviation|Mean
2617525|NCT01978314|Secondary|AUClast of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|AUClast = area under the concentration-time curve (time 0 to last sample with a quantifiable measurable concentration)|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||ng∙hr/mL||Standard Deviation|Mean
2617526|NCT01978314|Secondary|Tmax of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|Tmax = time of maximum observed concentration|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||hr||Standard Deviation|Mean
2617527|NCT01978314|Secondary|Cmax of FD001 and FD003 Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|Cmax = maximum observed concentration occurring at Tmax|PK parameters were evaluated using samples collected pre and post dose at day 2, as well as post dose on days 4, 8, 15, 22.|Intent-to-treat subject population analyzed. PK was not evaluated in Cohort 1 due to a contamination problem caused by the sample collection catheter used in this cohort. In addition, PK data was not collected for the single subject dosed in Group 4.|||ng/mL||Standard Deviation|Mean
2617528|NCT01978314|Primary|Number of Adverse Events Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product or investigational medical device.|Baseline through day 22|Intent-to-treat subject population|||adverse events|||Number
2617529|NCT01978314|Primary|Number of Subjects With Adverse Events Following Administration of VFI™ in Patients With Varying Degrees of Kidney Function|An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product or investigational medical device.|Baseline through day 22|Intent-to-treat subject population|||participants|||Number
2617530|NCT01978262|Other Pre-specified|Cytokine Responses to Influenza Vaccine|Identify optimal biomarkers of the inflammatory response after vaccination.|2 days|||||||
2617531|NCT01978262|Other Pre-specified|Cytokine Effect on Reproductive Hormone Levels|To explore whether inflammatory cytokine responses to IIV receipt are associated with changes in reproductive and stress hormone levels.|2 months|||||||
2617532|NCT01978262|Primary|Change in Levels of Progesterone After Influenza Vaccination|To explore whether receipt of IIV during the second week of the menstrual cycle (i.e., the week prior to ovulation) is associated with changes in steroid hormone levels, particularly decreases in progesterone, following ovulation.|2 months||||ng/ml||Standard Deviation|Mean
2617533|NCT01978236|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE were collected from the time the first dose of study treatment is administered until 30 days following discontinuation of study treatment regardless of initiation of a new cancer therapy using Medical Dictionary for Regulatory Activities (MedDRA)|Up to 2 years|Safety Set Population The Safety Set comprised of all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2617534|NCT01978236|Secondary|Number of Participants With Abnormal Clinical Laboratory Assessments|Laboratory assessments included parameters like Hematology, Standard Chemistry, Coagulation, Serum Pregnancy. Assessment of these parameters were planned to be performed by the central laboratory on screening, Day prior to surgery, Every 4 weeks after restart and Discontinuation, but were not analyzed as the study was terminated due to low enrollment.|Up to 2 years|Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment.||||||
2617535|NCT01978236|Secondary|Number of Participants With Abnormal Echocardiogram (ECHO)|ECHO include an evaluation for Left ventricular ejection fraction (LVEF) and both right- and left-sided valvular lesions. ECHO was planned to be performed at screening, Week 8 and every 16 weeks till discontinuation. data for ECHO was not summarized and listed as the study was terminated.|Up to 2 years|Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment.||||||
2617536|NCT01978236|Secondary|Number of Participants With Abnormal 12-lead Electrocardiograms (ECG)|112-lead ECGs were planned to be obtained at screening during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. At each assessment a 12-lead ECG was planned to be performed by qualified personnel at the site after at least a five-minute rest with the participants in a semi-recumbent or supine position. But data for 12-lead ECGs were not summarized and listed as the study was terminated.|Screening|Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment.||||||
2622815|NCT01936389|Primary|Evaluate the Ocular Hypotensive Efficacy of Rho Kinase Inhibitor (AR-12286 0.5% and 0.7%)|Goldmann Aplanation Tonometry (IOP mmHg) will be used to measure the ocular hypotensive efficacy.|6 months||||mmHg||Standard Deviation|Mean
2617537|NCT01978236|Secondary|Number of Participants With Abnormal Physical Examinations|A complete physical examination was planned which included assessments of the head, eyes, ears, nose, throat, skin, thyroid, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes, and extremities. Height and weight was also planned to be measured and recorded. A complete physical exam including a thorough genitourinary examination for female participants, inspection of the head and neck region, and digital rectal examination for both male and female participants was planned to be performed at Screening, and Month 12 or at discontinuation if discontinuation occurs prior to Month 12. If the participants had a genitourinary and rectal exam within 6 months of screening, these assessments need not to be repeated at screening. But data for physical examinations were not summarized and listed as the study was terminated.|Up to 2 years|Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment.||||||
2617538|NCT01978236|Secondary|Number of Participants With Abnormal Vital Signs|Vital sign measurements including temperature, respiratory rate, systolic and diastolic blood pressure, and pulse rate were planned to be performed but were neither summarized nor listed as the study was terminated.|Up to 2 years|Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment.||||||
2617539|NCT01978236|Secondary|Percentage of Participants With Overall Survival|Overall survival, defined as the time from first dose of study treatment to death for any reason, was planned to summarize using Kaplan-Meier quartile estimates along with two sided 95% confidence intervals. But were not performed as the study was terminated due to low enrollment.|Approximately 2 years or death whichever occurs first|Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment.||||||
2617540|NCT01978236|Secondary|Percentage of Participants With Overall Extracranial Response Rate in Unresected Lesions|Overall Extracranial Response Rate was defined as the percentage of participants with Complete response (CR) or Partial response (PR) at anytime as per modified Response Evaluation Criteria in Solid Tumors (RECIST). The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence and is determined programmatically based on the investigator's assessment of response at each time point. Overall Extracranial Response Rate was planned but not analyzed as the study was terminated due to low enrollment.|Approximately 2 years or death whichever occurs first|Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment.||||||
2617541|NCT01978236|Secondary|Maximum Percent Change From Baseline in the SLD of Unresected Intracranial Target Lesions|The maximum change from Baseline in the SLD of unresected intracranial target lesions was planned to be calculated as a percentage change from the baseline SLD. It was planned to be reported for the V600E and V600K analysis populations for each cohort and also aggregately if appropriate. This analysis was planned but not performed as the study was terminated due to low enrollment.|Up to 2 years|Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment.||||||
2617542|NCT01978236|Secondary|Percent Change From Baseline to Pre-surgery in the Sum of the Longest Diameters (SLD) of Intracranial Target Lesions|The change from Baseline to the pre-surgery intracranial disease assessment in the SLD of intracranial target lesions was planned to be calculated as a percentage change from the baseline SLD. It was planned to be reported for the V600E and V600K analysis populations for each cohort and also aggregately if appropriate. This analysis was planned but not performed as the study was terminated due to low enrollment.|Up to 2 years|Full Analysis Set. This analysis was planned but not performed as the study was terminated due to low enrollment.||||||
2617543|NCT01978236|Secondary|Number of Participants With Changes in Radiographic Tumors|Changes in the radiographic characteristics of the tumors were planned to be compared to (1) levels of dabrafenib, its metabolites and trametinib (where appropriate) in the brain metastases, plasma, and CSF, and (2) MAPK pathway activation status in tumors at the time of surgery. Results were planned to be compared to the analysis of early clinical responses in extracranial metastases, as determined by the Positron emission tomography (PET-CT) imaging. This analysis was planned but not performed as the study was terminated due to low enrollment|Up to 2 years|Full Analysis Set. Analysis was planned but not performed as the study was terminated due to low enrollment.||||||
2617544|NCT01978236|Secondary|Number of Participants With Changes in Mitogen-activated Protein Kinase (MAPK) Pathway Markers|Changes in MAPK pathway markers in paired extracranial biopsies taken pre-treatment, during craniotomy, and at disease progression, and changes in markers between post-operative intracranial and extracranial biopsies was planned but not performed as the study was terminated due to low enrollment.|Up to Day 15|Full Analysis Set. Analysis was planned but not performed as the study was terminated due to low enrollment.||||||
2617545|NCT01978236|Secondary|Concentrations of Dabrafenib, Its Metabolites Hydroxy-, Carboxy- and Desmethyl-dabrafenib) in Cerebrospinal Fluid (CSF) Samples|Concentrations of dabrafenib, its metabolites hydroxy-, carboxy- and desmethyl-dabrafenib) and trametinib in CSF (in participants who agree for optional collection of CSF at the time of brain tumor resection). Optional collection of CSF was obtained in the operating room on the day of brain metastasis resection. CSF samples for only one participant were collected and analyzed.|Day 15|Pharmacokinetic Analysis Set|||ng/mL|||Number
2617546|NCT01978236|Primary|Concentrations of Dabrafenib, Its Metabolites Hydroxy-, Carboxy- and Desmethyl-dabrafenib) and Trametinib (Cohort B Only) in CSF Samples.|Blood samples for pharmacokinetic analysis of dabrafenib and its active metabolites, including hydroxy-, carboxy-, and desmethyl-dabrafenib and trametinib (as appropriate), were planned but not collected.|Pre-surgery and post-surgery on Day 15|Pharmacokinetic Analysis Set||||||
2617547|NCT01978236|Primary|Concentrations of Dabrafenib, Its Metabolites Hydroxy-, Carboxy- and Desmethyl-dabrafenib in Parenchymal Brain Metastases|Concentrations of dabrafenib, its metabolites, hydroxy-, carboxy, and desmethyl-dabrafenib, and possibly other drug-related species were quantified in the pharmacokinetic tissue sample by an investigative Liquid chromatography- mass spectrometry (LC-MS)/MS method. The spatial distribution of dabrafenib, its metabolites, hydroxy-, carboxy, and desmethyl-dabrafenib and possibly other drug-related species in the tissue samples were determined using an investigative matrix assisted laser desorption ionization (MALDI) analysis method. Parenchymal brain metastases and extracranial metastases using MALDI imaging was not determined for all participants (completed by GSK for the first two participants enrolled)|Day 15|Pharmacokinetic Analysis Set|||ng/mL|||Number
2617548|NCT01978236|Primary|Concentrations of Dabrafenib, Its Metabolites Hydroxy-, Carboxy- and Desmethyl-dabrafenib in Peripheral Blood (Plasma)|Blood samples for pharmacokinetic analysis of dabrafenib and its active metabolites, including hydroxy-, carboxy-, and desmethyl-dabrafenib were collected on day of surgical resection of the brain metastasis(es), Two samples were collected before surgery and 2 samples after surgery with one hour gap in between. Upon collection blood was placed on wet ice. Plasma was isolated within 60 minutes of collection and frozen at -20 degree celsius.|Pre-surgery and post-surgery on Day 15|The Pharmacokinetic analysis set included all participants who provided at least one evaluable Pharmacokinetic concentration.|||Nano grams per milliliter (ng/mL)|||Number
2617549|NCT01978184|Secondary|Rate of R0 Resection|The proportion of participants having resection for cure or complete remission, in which the surgical margins are negative for tumor cells. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.|At the time of surgery (≥2 weeks and ≤6 weeks post chemotherapy)|Participants that were assigned to treatment and did not withdraw consent prior to being given drug.|||proportion of participants||95% Confidence Interval|Mean
2617550|NCT01978184|Secondary|Positive Lymph Node Involvement|The proportion of participants with positive (disease) lymph nodes involvement.|At the time of surgery (≥2 weeks and ≤6 weeks post chemotherapy)|Participants that were assigned to treatment and did not withdraw consent prior to being given drug.|||proportion of participants||95% Confidence Interval|Number
2617551|NCT01978184|Secondary|Carbohydrate Antigen 19-9 (CA19-9) Response|Levels of Carbohydrate antigen 19-9 (CA19-9) response to pre-operative gemcitabine/ nab-paclitaxel measured in the serum (original scale).|After treatment (50-67 days post treatment/surgery)|Participants that were assigned to treatment and did not withdraw consent prior to being given drug.|||units per milliliter (U/mL)||Standard Deviation|Mean
2617552|NCT01978184|Secondary|Carbohydrate Antigen 19-9 (CA19-9) Response|Levels of Carbohydrate antigen 19-9 (CA19-9) response to pre-operative gemcitabine/ nab-paclitaxel measured in the serum (original scale)|Prior to treatment (average 73.3 +/- 9.9 days prior to surgery)|Participants that were assigned to treatment and did not withdraw consent prior to being given drug.|||units per milliliter (U/mL)||Standard Deviation|Mean
2617553|NCT01978184|Primary|Age-Adjusted Charlson Comorbidity Index|The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis codes found in administrative data, such as hospital abstracts data. Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. Up to 12 comorbidities with various weightings can result in a maximum score of 24. The minimum score is zero.|Prior to treatment|Patients who went to surgery and were evaluable for Evans Grade Histopathologic Response.|||Participants|||Count of Participants
2617554|NCT01978184|Primary|Robotic Resection Surgery|The number of participants who had robotic resection surgery. (Robotic surgery variable used in the proportional odds logistic regression, secondary analysis of Evans Grade).|At the time of surgery (≥2 weeks and ≤6 weeks post chemotherapy)|Patients who went to surgery and were evaluable for Evans Grade Histopathologic Response.|||Participants|||Count of Participants
2617555|NCT01978184|Primary|Type of Surgical Procedure (Operation)|The number of participants in having each type of surgical resection procedure: Celiac Axis Resection With Distal Pancreatectomy (DPCAR) (Modified Appleby), Distal Pancreatectomy, Total Pancreatectomy, or Whipple. (Operation variable used in the proportional odds logistic regression, secondary analysis of Evans Grade).|At the time of surgery (≥2 weeks and ≤6 weeks post chemotherapy)|Patients who went to surgery and were evaluable for Evans Grade Histopathologic Response.|||Participants|||Count of Participants
2617556|NCT01978184|Primary|Cancer Diagnosis Stage|"The number of participants in cancer diagnosis stage groups. Stage 0: cancer hasn't spread to nearby tissues/located in the same of origin.Stage I: cancers hasn't grown deeply into nearby tissues or spread to lymph nodes or other parts of the body. Stage II and III: cancers have grown more deeply into nearby tissues (may have metastasized to lymph nodes but not other parts of the body). Stage IV: most advanced stage (metastatic cancer) ; cancer has spread to other parts of the body. Stages subdivided further into the categories A (less agressive disease) and B (more advanced cancer). Example: stage IIA is less aggressive than stage IIB, but stage IIIA is more aggressive than stage IIB. (Stage variable used in the proportional odds logistic regression, secondary analysis of Evans Grade)."|Baseline - At the time of diagnosis, prior to treatment|Patients who went to surgery and were evaluable for Evans Grade Histopathologic Response.|||Participants|||Count of Participants
2617557|NCT01978184|Primary|CT Tumor Size|Tumor size as measured via computerized tomography (CT) scan (as a variable in the proportional odds logistic regression, secondary analysis of Evans Grade).|Baseline - At the time of diagnosis, prior to treatment|Patients who went to surgery and were evaluable for Evans Grade Histopathologic Response.|||centimeters||Standard Deviation|Mean
2617558|NCT01978184|Primary|Age at Diagnosis|The mean age of patients at the time of diagnosis of disease (as a variable in the proportional odds logistic regression, secondary analysis of Evans Grade).|Baseline - At the time of diagnosis, prior to treatment|Patients who went to surgery and were evaluable for Evans Grade Histopathologic Response.|||years||Standard Deviation|Mean
2617559|NCT01978184|Primary|Evans Grade Histopathologic Response|The number of patients who exhibited an Evans grade Histologic response (I, IIA, IIB, or III) to pre-operative gemcitabine / nab-paclitaxel. Histological response validated scoring system by Evans is as follows: Grade I: 1-9% tumor destruction, Grade II: 10 - 90%, Grade III: >90% tumor destruction (Grade IIA = 10-50% of tumor cells destroyed; Grade IIB = 50-90% of tumor cells destroyed), Grade IV: Absence of viable tumor cells.|Up to 4 years|Patients who went to surgery and were evaluable for Evans Grade Histopathologic Response.|||number of participants|||Number
2617611|NCT01977781|Secondary|Intraocular Pressure|Intraocular pressure is the measure of the fluid pressure within the eye as measured by tonometry. Intraocular pressure is normally measured in millimeters of mercury (mmHg). The normal range for intraocular pressure is 12-20 mmHg, there is no better or worse measurement.|10 weeks|Measurements are reported from the 10 week study visit. At this time 3 subjects were lost to follow-up and 4 subjects dropped out of the study due to burning sensations. 3 subjects dropped out from the Tacrolimus arm and 1 subject dropped out of the Methylprednisolone arm.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2617560|NCT01978145|Secondary|Change From Baseline in COPD Assessment Test (CAT) Scores at Week 12|The CAT is a participant-completed instrument designed to provide a simple and reliable measure of health status in COPD for the assessment and long-term follow-up of the individual participant. The CAT consists of eight items, each formatted on a semantic differential scale. Participants rated their experience on a 6-point scale for each question, ranging from 0 to 5 with a maximum total score of 40. Higher scores indicate greater disease impact. CAT of each participant was assessed at Baseline (Day 1) and Week 12 (Day 85) of each treatment period. Change from Baseline within each period was calculated as values at Week 12 minus period specific Baseline value. The change from Baseline in CAT overall score at Week 12 was analyzed using a mixed effects ANCOVA model, with participant-level Baseline CAT overall score, adjusted treatment period specific Baseline CAT overall score, treatment group, treatment period as fixed effects and participant as a random effect.|Baseline and Week 12 of each treatment period|ITT population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2617561|NCT01978145|Secondary|Change From Baseline in St George's Respiratory Questionnaire-COPD (SGRQ C) Score at Week 12|The SGRQ-C is a 40-item COPD-specific questionnaire designed to measure the effect of COPD and its treatment on the participant's health-related quality of life (HRQoL). The SGRQ-C includes 14 questions with a total of 40 items grouped into three components (symptoms, activity, and impacts). Each questionnaire response has a unique empirically derived weight. The lowest possible weight is zero and the highest is 100. Higher scores indicate greater impairment of HRQoL. HRQoL of participants was assessed using the SGRQ-C at Baseline (Day 1) and Week 12 of each treatment period. Change from Baseline was calculated as value at Week 12 minus the period specific Baseline value. Change from Baseline in SGRQ total score at Week 12 was analyzed using a mixed effects ANCOVA model, with participant-level Baseline SGRQ total score, adjusted treatment period-specific Baseline SGRQ total score, treatment group, and treatment period as fixed effects and participant as a random effect.|Baseline and Week 12 of each treatment period|ITT population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2617562|NCT01978145|Secondary|Change From Baseline in Transition Dyspnoea Index (TDI) Focal Score at Days 28, 56 and 85|Baseline Dysponea Index (BDI) and Transition Dyspnoea Index (TDI) are interview-based measurements of breathlessness due to COPD related daily living activities. Scores depend on ratings for 3 categories: functional impairment, magnitude of task and magnitude of effort. BDI was collected at Day 1 and TDI at Days 28, 56 and 85 of each treatment (trt) period. Each BDI scale has 5 possible scores ranging from 0 to 4, with 0 (worst) to 12 (best) as the total range. Each TDI scale has 7 possible scores ranging from -3 to +3, with -9 (worst) to +9 (best) as the total range. TDI focal score >=1 is considered to be a clinically meaningful change. Change from Baseline was calculated as TDI minus BDI values. Analysis was performed using MMRM by par. level BDI focal score, adjusted period-specific BDI focal score, trt group, trt period, visit, visit*trt group, visit*par. level BDI focal score, visit*adjusted period-specific BDI focal score as a fixed effect and with par. as a random effect.|Baseline, and Days 28, 56 and 85|ITT population. Only those participants available at the specified time points were analyzed (n=X, X in the category title).|||Scores on a scale||Standard Error|Least Squares Mean
2617563|NCT01978145|Secondary|FEV1 Area Under the Curve From 0 to 10 Hours (AUC [0-10]) on Day 85 of Each Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1. The FEV1 was measured on Day 85 of each treatment period at time 0 (predose),15 minutes, 30 minutes, 1, 2, 4, 6, and 10 hours post morning dosing for determination of AUC 0 to10 hours. The AUC was analyzed using a mixed effects analysis of covariance (ANCOVA) with participant-level Baseline (Day 1 trough FEV1), adjusted period-specific Baseline (Day 1 trough FEV1), treatment group and period as fixed effects and participant as a random effect.|Day 85 of each treatment period|ITT population. Only those participants available at the specified time points were analyzed.|||Liter*hours||Standard Error|Least Squares Mean
2617564|NCT01978145|Secondary|Change From Baseline in Trough Morning Forced Expiratory Volume in 1 Second (FEV1) at Day 28 and 56|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The trough FEV1 at Days 28 and 56 is defined as morning prebronchodilator and predose (12 hours after the last evening dose Days 27 and 55). Trough FEV1 was measured electronically by spirometer in the morning, before using the bronchodilator and predose, at Days 28 and 56 of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on day 1 in each treatment period. Change from Baseline within each period was calculated as trough FEV1 at Day 85 minus the period specific Baseline value. The change from Baseline in trough FEV1 was analyzed using mixed model for repeated measures analysis, having fixed effect participant level Baseline, adjusted period-specific Baseline, treatment group, period, visit, visit by treatment, visit by participant level Baseline, visit by adjusted period-specific Baseline, with participant as random effect.|Baseline and Days 28 and 56 of each treatment period|Intent-to-Treat (ITT) Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Liters (L)||Standard Error|Least Squares Mean
2617565|NCT01978145|Primary|Change From Baseline in Trough Morning Forced Expiratory Volume in 1 Second (FEV1) at Day 85|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The trough FEV1 is defined as morning prebronchodilator and predose (12 hours after the last evening dose Day 84). Trough FEV1 was measured electronically by spirometer in the morning, before using the bronchodilator and predose, at Week 12 (Day 85) of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on day 1 in each treatment period. Change from Baseline within each period was calculated as trough FEV1 at Day 85 minus the period specific Baseline value. The change from Baseline in trough FEV1 was analyzed using mixed model for repeated measures analysis, having fixed effect participant level Baseline, adjusted period-specific Baseline, treatment group, period, visit, visit by treatment, visit by participant level Baseline, visit by adjusted period-specific Baseline, with participant as random effect.|Baseline and Day 85 of each treatment period|Intent-to-Treat (ITT) Population: all participants randomly assigned to treatment who received at least one dose of randomized study treatment in the treatment period. Only those participants available at the specified time points were analyzed.|||Liters (L)||Standard Error|Least Squares Mean
2618402|NCT01971723|Primary|Estrogen Outcomes|Measurements for estrogen will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark||||pg/ml||Standard Deviation|Mean
2617566|NCT01978119|Secondary|Change From Baseline in the Percentage (%) of Rescue-free Days Over 12 Weeks (From Paper Diary Card) for Each Treatment Period(TP)|A rescue-free day is defined as a 24-hour period with no rescue medication usage recorded (i.e. both the day-time and night-time numbers of puffs of Salbutamol/Albuterol are zero). Percentage of Rescue-Free Days was calculated over each 12-week Treatment Period, dividing the number of rescue-free days by the length of the TP. The BL value of change from BL in % rescue free days is defined as an average of the last 7 available recorded values the Screening Period (for treatment period 1) and of the Washout Period (for treatment period 2). Change from BL was the difference over 12 weeks for each treatment period compared to BL. The change from BL in the % of rescue medication-free days averaged over the 12-week TP was analyzed, using mixed effects ANCOVA model, with par level BL % of rescue-free days, adjusted period-specific BL % of rescue-free days treatment group and period as fixed effects and par as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed|||Percentage of rescue-free days||Standard Error|Least Squares Mean
2617567|NCT01978119|Secondary|Change From Baseline in Asthma Control Test (ACT) Over 12 Weeks for Each Treatment Period|The ACT is a 5-item questionnaire with a score of 1 to 5 for each item (1=poor control and 5=good control). The scores from each question were added to give an overall score. Baseline was defined as the value obtained predose (0 minutes) on day 1 of each Treatment Period. Change from Baseline was the difference in ACT score at the timepoint compared to Baseline score. The change from Baseline in overall ACT score was analysed, using mixed effects ANCOVA model, with participant level Baseline overall ACT score, adjusted period-specific Baseline overall ACT score, treatment group and period as fixed effects and participant as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed|||Scores on the scale||Standard Error|Least Squares Mean
2617568|NCT01978119|Secondary|Change From Baseline in the Percentage of Symptom-Free Days From Paper Diary Card Over 12 Weeks|A Symptom-Free day was defined as a 24-hour period with no symptoms recorded. Percentage of Symptom-Free Days was calculated dividing number of Symptom-Free days by the length of the Treatment Period. The baseline value of change from baseline in % of symptom free days is defined as an average of the last 7 available recorded values the Screening Period (for treatment period 1) and of the Washout Period (for treatment period 2). Change from Baseline was the difference in percentage of Symptom-Free days at week 12 compared to Baseline. The change from Baseline in the percentage of Symptom-Free days averaged over the 12-week Treatment Period was analyzed, using mixed effects ANCOVA model, with participant level Baseline percentage of Symptom-Free days, adjusted period-specific Baseline percentage of Symptom-Free days, treatment group and period as fixed effects and participant as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed|||Percentage of symptom-free days||Standard Error|Least Squares Mean
2617569|NCT01978119|Secondary|Change From Baseline in Day-time(AM) and Night-time (PM) Asthma Symptoms(Sy) From Paper Diary Card (PDC) Over 12 Weeks(wk) for Each Treatment Period(TP)|AM Sy scores were recorded nightly on PDC using the scale:0=No Sy during day,1=Sy for one short period during day,2=Sy for two or more short periods during day,3=Sy for most of day-not affecting normal daily activities,4=Sy for most of day-did affect normal daily activities,5=Sy so severe-could not go to work or perform normal daily activities. Similarly, PM Sy scores were recorded every morning using the scale:0=No Sy during night,1=Sy causing me to wake once(or early),2=Sy causing me to wake twice or more(or early),3=Sy causing me to be awake most of night,4=Sy severe-did not sleep. BL= average of last 4 available of the last 7 days of Screening Period(TP 1) and of Washout Period(TP 2). Change from BL in average of daily scores=difference over 12 wks for each TP compared to BL. AM and PM Sy Scores were separately averaged over each of the two 12-wk TP. Total value of each endpoint over 12-wk TP was divided by number of days with non-missing data to obtain an average for each subject|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Participants at each time point may have been different therefore a total of 82 participants analyzed represents the overall ITT population.|||Scores on the scale||Standard Deviation|Mean
2617570|NCT01978119|Secondary|Change From Baseline (BL) in Rescue Medication Use Over 12 Weeks (From Paper Diary Card) for Each Treatment Period (TP)|Rescue medication usage for each 24-hour period is defined as the total numbers of puffs of Salbutamol/Albuterol within 24 hours (i.e. number taken during the day and number taken during the night). The total usage over the 12 week TP was divided by the number of days with nonmissing rescue medication data to get an average usage per participant. BL is the average of the last 4 available recorded values during the last 7 days of the Screening Period (for TP 1) and of the Washout Period (for TP 2). Change from BL in average usage of rescue medication was the difference over 12 weeks for each TP compared to BL. The change from BL in the percentage of rescue medication use averaged over the 12-week TP was analysed using mixed effects ANCOVA model, with par level BL rescue medication use, adjusted period-specific BL rescue medication use, treatment group and period as fixed effects and par as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed|||Puffs per day||Standard Error|Least Squares Mean
2617571|NCT01978119|Secondary|Change From Baseline (BL) in Morning Peak Expiratory Flow Rate (PEFR) Over 12 Weeks (From Paper Diary Card) for Each Treatment Period(TP)|The PEFR is a paricipant's(par) maximum speed of expiration, as measured with a peak flow meter(PFM). All par were issued a PFM and instructed to perform the activity in triplicate in the morning prior to taking the bronchodilator. The best among the 3 readings was selected. Efficacy measurement was recorded by the par in the paper Diary Card for morning PEFR. The total PEFR over the 12 week TP was divided by the number of days with non-missing PEFR data to obtain an average for each par. Change from BL in average morning PEFR is the difference over 12 weeks for each TP compared to BL. BL is the average of the last 4 available recorded values during the last 7 days of the Screening Period (for TP 1) and of the Washout Period (for TP 2). The change from BL in the PEFR averaged over the 12-week TP was analysed using a mixed effects ANCOVA model with participant level BL PEFR, adjusted period-specific BL PEFR, treatment group, and period as fixed effects, and par as a random effect.|Baseline and up to Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed|||Liters per minute||Standard Error|Least Squares Mean
2617572|NCT01978119|Secondary|Change From Baseline in Morning Trough FEV1 at Day 28 and Day 56|Pulmonary function was measured by FEV1, a measure of lung function, and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry at predose (Baseline), on Days 28 and 56 of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on Day 1of each Treatment Period. Change from Baseline within each period was calculated as trough FEV1 at Day 28 and 56 minus the period specific Baseline value.The change from Baseline in trough FEV1 at Day 28 and Day 56 was analysed via the primary analysis model. Least Squares mean values for the change from Baseline in trough FEV1 at Day 28 and Day 56 were obtained from the primary analysis model (for each treatment and for the treatment difference), and displayed alongside corresponding 95% confidence intervals.|Baseline, Day 28, and Day 56|ITT population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Participants at each time point may have been different therefore a total of 82 participants analyzed represents the overall ITT population.|||Liter||Standard Error|Least Squares Mean
2617573|NCT01978119|Secondary|FEV1 AUC (0-12) at Day 85 of Each Treatment Period|The AUC was analysed using a mixed effects analysis of covariance (ANCOVA) with participant-level baseline (day 1 trough FEV1), adjusted period-specific baseline (day 1 trough FEV1), treatment group and period as fixed effects and participant as a random effect.|Day 85 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed.|||Liter*hours||Standard Error|Least Squares Mean
2617574|NCT01978119|Secondary|FEV1 Area Under the Curve From 0 to 12 Hours (AUC [0-12]) on Day 1 of Each Treatment Period|The AUC was analysed using a mixed effects analysis of covariance (ANCOVA) with participant-level baseline (day 1 trough FEV1), adjusted period-specific baseline (day 1 trough FEV1), treatment group and period as fixed effects and participant as a random effect.|Day 1 of each Treatment Period|ITT population, Only those participants available at the specified time points were analyzed.|||Liter*hours||Standard Error|Least Squares Mean
2617575|NCT01978119|Primary|Change From Baseline in Trough Morning Forced Expiratory Volume in 1 Second (FEV1) at Day 85|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The trough FEV1 is defined as morning prebronchodilator and predose (12 hours after the last evening dose Day 84). Trough FEV1 was measured electronically by spirometer in the morning, before using the bronchodilator and predose, at Week 12 (Day 85) of each Treatment Period. Baseline was defined as the value obtained predose (0 minutes) on day 1 in each treatment period. Change from Baseline within each period was calculated as trough FEV1 at Day 85 minus the period specific Baseline value. The change from Baseline in trough FEV1 was analysed using Mixed Model for Repeated Measures analysis, having fixed effect Participant level Baseline, Adjusted period-specific Baseline, Treatment group, Period, Visit, Visit by treatment, Visit by Participant level Baseline, Visit by Adjusted period-specific Baseline, with participant as a random effect.|Baseline and Day 85|Intent-to-Treat (ITT) Population: all participants randomly assigned to treatment who received at least one dose of randomised study treatment in the Treatment Period. Only those participants available at the specified time points were analyzed.|||Liter||Standard Error|Least Squares Mean
2617576|NCT01978093|Secondary|Percentage of Subjects Reporting Any Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 to Month 17-20)|The analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose Total Vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.|||Percentage of subjects||95% Confidence Interval|Number
2617577|NCT01978093|Secondary|Percentage of Subjects Reporting Any Unsolicited AEs.|"Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited adverse event."|During 31 days (Day 0 to Day 30) after all vaccines post-primary (Dose 1-3) and post-fourth dose (Dose 4)|The analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose Total Vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.|||Percentage of subjects||95% Confidence Interval|Number
2617578|NCT01978093|Secondary|Percentage of Subjects Reporting Any Solicited General AEs.|Solicited general AEs include fever [defined as temperature ≥38.0 degrees Celsius (°C) by any method], drowsiness, irritability/fussiness and loss of appetite.|4 days (Day 0 to Day 3) after all vaccines post-primary and post-fourth dose.|The analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose Total Vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.|||Percentage of subjects||95% Confidence Interval|Number
2617579|NCT01978093|Secondary|Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE).|Solicited local adverse events include pain, redness and swelling at injection site.|4 days (Day 0 to Day 3) after all vaccines post-primary and post-fourth dose|This analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose total vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.|||Percentage of subjects||95% Confidence Interval|Number
2617580|NCT01978093|Secondary|Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F|The cut-off values are 0.15, 0.26, 0.35 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups|1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14)|This analysis was perfomed on First three doses ATP for analysis of immunogenicity and on the Fourth dose ATP cohort for analysis of immunogenicity which included all evaluable subjects for whom data were available.|||Percentage of subjects||95% Confidence Interval|Number
2617581|NCT01978093|Secondary|GMCs for Anti-HAV Antibodies ≥15mIU/mL.|The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups|1 month post-dose 2 of HAV (Month 17-20).|This analysis was performed on Havrix ATP cohort for analysis of immunogenicity which included all evaluable subjects who have received the first and second dose of Havrix and for whom assay results were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2617582|NCT01978093|Secondary|Anti-HAV GMCs ≥ 15 mIU/mL|The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups|1 month post-dose 1 of HAV (M11-14).|The analysis was performed on the Fourth dose ATP cohort for analysis of immunogenicity, which included all vaccinated subjects for whom data are available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2617583|NCT01978093|Secondary|Percentage of Subjects With Anti-HAV Antibodies ≥ 15 mIU/mL|The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.|1 month post-dose 1 of Havrix (Month 11-14)|The analysis was performed on the Fourth dose ATP cohort for analysis of immunogenicity, which included all vaccinated subjects for whom data are available.|||percentage of subjects||95% Confidence Interval|Number
2617584|NCT01978093|Secondary|Percentage of Subjects With Anti-rotavirus IgA Antibody Concentrations ≥ 20 Units (U)/mL|The cut-off value is 20 Units (U)/mL Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.|2 month post-dose 2 of Rotarix (Month 4)|The analysis was performed on the Rota ATP cohort for analysis of immunogenicity which included all vaccinated subjects for whom data were available.|||Percentage of subjects||95% Confidence Interval|Number
2617585|NCT01978093|Secondary|Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY|The cut-off values are dilutions of 1:8, 1:16 and 1:32. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.|1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14).|The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months11-14) which included all evaluable subjects for whom immunogenicity results were available.|||Titres||95% Confidence Interval|Geometric Mean
2617586|NCT01978093|Secondary|Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32.|The cut off values are dilutions of 1:8, 1:16 and 1:32. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.|1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14).|The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months11-14) which included all evaluable subjects for whom immunogenicity results were available.|||Percentage of subjects||95% Confidence Interval|Number
2617587|NCT01978093|Secondary|Percentage of Subjects With Anti-PRP Antibody Concentrations ≥1.0 µg/mL|The cut-off value for this assay was 1.0 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.|2 months post-dose 2 [PedHib group only (Month 4)] and 1 month postdose 3 [HibCY group only (Month 5)].|The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 4 and Month 5) which included all evaluable subjects for whom immunogenicity results were available.|||Percentage of subjects||95% Confidence Interval|Number
2617588|NCT01978093|Secondary|Anti-PRP GMCs≥ 0.15 µg/mL.|"Anti-PRP antibody concentrations were assessed by Enzyme-Linked-Immunosorbent-Assay (ELISA), tabulated as Geometric Mean Concentrations (GMCs) and expressed in micrograms per mililiter (µg/mL).The cut-off value for this assay was 0.15 µg/mL.~Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups."|2 months post-dose 2 [PedHib Group only (Month 4)], 1 month post-dose 3 (Month 5 for HibCY group and Month 11-14 for PedHib Group) and 1 month post-dose 4 [HibCY Group only (Month 11-14)]|The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 4 and Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months 11-14) which included all evaluable subjects for whom immunogenicity results were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2617612|NCT01977781|Secondary|Visual Acuity|Visual acuity is measured by asking subjects to read letters on a chart that consists of different rows of letters. Each row of letters corresponds to different levels of visual acuity. The Logarithm of the Minimum Angle of Resolution (LogMAR) scale generally ranges from 0 to 1, with 0 corresponding to 20/20 vision and 1 corresponding to 20/200 vision. The range from 0-1 is not absolute, however, as patients who have vision better than 20/20 or vision worse than 20/200 will score out side of the 0 to 1 range.|10 weeks|Measurements are reported from the 10 week study visit. At this time 3 subjects were lost to follow-up and 4 subjects dropped out of the study due to burning sensations. 3 subjects dropped out from the Tacrolimus arm and 1 subject dropped out of the Methylprednisolone arm.|||LogMAR Scale||Standard Deviation|Mean
2617589|NCT01978093|Secondary|Percentage of Subjects With Anti-PRP Antibody Concentrations ≥0.15 µg/mL.|The cut-off value for this assay was 0.15 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.|2 months post-dose 2 [PedHib Group only (Month 4)], 1 month post-dose 3 (Month 5 for HibCY group and Months 11-14 for PedHib Group) and 1 month post-dose 4 [HibCY Group only (Month 11-14)]|The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 4 and Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months 11-14) which included all evaluable subjects for whom immunogenicity results were available.|||Percentage of subjects||95% Confidence Interval|Number
2617590|NCT01978093|Primary|Anti-S. Pneumoniae GMCs|"Antibody concentrations against S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F were assessed by ELISA, tabulated as GMCs and expressed in µg/mL.~Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch"|1 month post-dose 4 of Prevnar 13 (Month 11-14)|The analysis was performed on the Forth dose ATP cohort for analysis of immunogenicity, which included all evaluable subjects who have received four doses of Prevnar 13 vaccine and for whom immunogenicity results were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2617591|NCT01978093|Primary|Percentage of Subjects With Anti-Hepatitis A (Anti-Havrix) Antibody Concentrations ≥ 15mIU/mL|"Percentage of subjects with Anti-Havrix (Anti-HAV) antibody concentrations was assessed. The cut-off value is ≥15 mIU/mL.~Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch"|1 month post-dose 2 of Havrix (Month 17-20)|The analysis was performed on the Havrix ATP cohort for analysis of immunogenicity which include all evaluable subjects who received two doses of Havrix vaccine and for whom immunogenicity results were available.|||Percentage of subjects||95% Confidence Interval|Number
2617592|NCT01978093|Primary|Anti-Streptococcus (S) Pneumoniae GMCs|"Antibody concentrations against S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F were assessed by ELISA, tabulated as GMCs and expressed in µg/mL.~Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch."|1 month post-dose 3 of Prevnar 13 (Month 5)|The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity, which included all evaluable subjects who have received three doses of Prevnar 13 vaccine and for whom immunogenicity results were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2617593|NCT01978093|Primary|Anti-rotavirus Serum Immunoglobulin A (IgA) Geometric Mean Concentrations (GMCs).|"Anti-rotavirus serum IgA was assessed by ELISA, tabulated as GMCs and expressed in Units per mililiter (U/mL).Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.~Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per a hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch"|2 months post-dose 2 of Rotarix (Month 4)|The analysis was performed on the Rota ATP cohort for analysis of immunogenicity, which included all evaluable subjects who received the two doses of Rotarix vaccine and for whom immunogenicity results were available.|||U/mL||95% Confidence Interval|Geometric Mean
2617594|NCT01978093|Primary|Percentage of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 1.0 µg/mL|"Percentage of subjects with Anti-PRP antibody concentrations≥1.0 µg/mL were assessed.~Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts. Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch."|1 month after the fourth dose for HibCY Group and 1 month after third dose for PedHIB Group [Month (M) 11-14]|The analysis was performed on the Fourth dose According to Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who have received 3 vaccine doses in the first 3-doses vaccination course and who have received the fourth vaccine dose and the first Havrix dose.|||Percentage of subjects||95% Confidence Interval|Number
2617595|NCT01977937|Secondary|Opiate Usage in the Gabapentin Group Versus Control.|Total the amount of Hydromorphone and Oxycodone used in milligrams per kilogram in each patient post-operatively, convert this amount to morphine equivalents, and determine if there is a significant difference between the Gabapentin versus Placebo group.|Five Days||||morphine equivalents mg per kg||Standard Deviation|Mean
2618466|NCT01971086|Secondary|Subjective Assessment of the Physicians of Overall Treatment Efficacy at the Closing/Final Visit.|The efficacy of the treatment was rated by the physician at the closing/final visit for every patient.|up to day 11|Patients from FAS.|||participants|||Number
2617596|NCT01977937|Primary|Difference in Pain Control When Adding Gabapentin to a Multimodal Pain Management Protocol in Pediatric Post-operative Posterior Spinal Fusion Patients.|"Patients will rate their pain using the Visual Analog Pain Scale (VAS). The VAS is a 10 cm line with anchors of no pain and worst pain imaginable. Patients rate their pain by marking on the 10 cm line where they feel their pain is at the time. The mark is then measured according to where it is along the 10 cm line and reported (range is 0.0 at the no pain end on the left up to 10.0 at the worst pain imaginable on the right). Lower pain scores on the VAS scale are considered a better outcome. The numbers seen in the outcome measure data table below represent an average of the total postoperative VAS scores recorded for each patient from each arm for the duration of their hospital stay."|five days||||pain score on a scale||Standard Deviation|Mean
2617597|NCT01977846|Secondary|Yearly Rate of Loss of the Central Ring Retinal Thickness|Yearly decrease of the central ring retinal thickness using SD-OCT scans from a 20° x 20° scan area centered on the fovea. Central area defined as ETDRS fields 9. Data are only available for the Prospective cohort.|Participants followed at Baseline, 6 months, 12 months and 24 months|All visits of eligible eyes of the 258 participants with gradable thickness in the inner ring. Only OCT scans with adequate and fair quality are included|||microns/year|eyes|95% Confidence Interval|Mean
2617598|NCT01977846|Secondary|Yearly Rate of Loss of the Inner Ring Retinal Thickness|Yearly decrease of the inner ring retinal thickness using SD-OCT scans from a 20° x 20° scan area centered on the fovea. Inner ring defined as ETDRS fields 5-8. Data are only available for the Prospective cohort.|Participants followed at Baseline, 6 months, 12 months and 24 months|All visits of eligible eyes of the 258 participants with gradable thickness in the inner ring. Only OCT scans with adequate and fair quality are included|||microns/year|eyes|95% Confidence Interval|Mean
2617599|NCT01977846|Secondary|Yearly Rate of Loss of Outer Ring Retinal Thickness|Yearly decrease of outer ring retinal thickness using SD-OCT scans from a 20° x 20° scan area centered on the fovea. Outer ring defined as ETDRS fields 1-4.|Participants followed at Baseline, 6 months, 12 months and 24 months|All visits of eligible eyes of the 258 participants with gradable thickness in the outer ring. Only OCT scans with adequate and fair quality are included|||microns/year|eyes|95% Confidence Interval|Mean
2617600|NCT01977846|Secondary|Yearly Rate of Loss of Overall Retinal Thickness|Yearly decrease of overall retinal thickness using spectral domain optical coherence tomography (SD-OCT) scans from a 20° x 20° scan area centered on the fovea. Data are only available for the Prospective cohort.|Participants followed at Baseline, 6 months, 12 months and 24 months|All visits of eligible eyes of the 258 participants with gradable overall thickness. Only OCT scans with adequate and fair quality are included|||microns/year|eyes|95% Confidence Interval|Mean
2617601|NCT01977846|Secondary|Difference in the Rate of Retinal Sensitivity Change Per Year Between Photopic and Scotopic Micro-perimetry Testing|Difference in the yearly rate of change in retinal sensitivity under photopic and scotopic conditions. Sensitivity tested with a Nidek MP-1. Scotopic sensitivity was obtained using a 40 points test pattern, and photopic sensitivity was obtained using a 68 points test pattern in a subset of Prospective cohort patients|2 years|Photopic microperimetry was obtained in a subset of patients, in a single designated study eye|||dB/year|eyes|95% Confidence Interval|Mean
2617602|NCT01977846|Secondary|Yearly Rate of Visual Acuity Loss|Yearly change of visual acuity. Visual acuity measures of best-corrected or presenting VA extracted from medical record charts. Prospective cohort is best-corrected visual acuity using Early-Treatment Diabetic Retinopathy study methods|2-12 years||||logMAR/year|eyes|95% Confidence Interval|Mean
2617603|NCT01977846|Secondary|Yearly Rate of Loss of Retinal Sensitivity as Measured by Scotopic Microperimetry (MP)|The yearly rate of change in retinal sensitivity. Sensitivity tested with a Nidek MP-1 machine using a modified Humphrey 10-2 grid. The sensitivity was the average sensitivity from a 68-points test pattern (Prospective cohort only)|2 years|Microperimetry data are available for only the Prospective cohort at centers with required equipment|||dB/year|eyes|95% Confidence Interval|Mean
2617604|NCT01977846|Primary|Yearly Progression Rate of Atrophic Lesions Using Fundus Autofluorescence (FAF) Images|Yearly increase in area of decreased auto-fluorescence (DAF) which is defined as the sum of definite and questionable decreased auto-fluorescence|2-12 years|Eyes of participants with at least 2 visits with gradable fundus auto-fluorescence images with atrophic lesions present|||mm^2/year|eyes|95% Confidence Interval|Mean
2617605|NCT01977820|Primary|Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Death and AEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Screening up to 24 weeks + 4-week follow-up|The safety analysis population included all the randomized subjects who received at least one dose of study treatment.|||Subjects|||Number
2617606|NCT01977794|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, AEs Leading to Discontinuation and AEs Leading to Death|An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs was AEs that started or worsened in severity on or after the date of first dose of IMP until the end of the study. AEs leading to death and discontinued were also presented.|Baseline up to Day 127 (end of trial)|Safety analysis set included all subjects who received at least 1 dose of IMP.|||subjects|||Number
2617607|NCT01977794|Secondary|Change From Baseline in Heart Rate (HR) After 18 Weeks of Treatment|Baseline was defined as the latest HR before study treatment administration|Baseline, Week 18|MITT analysis set was defined as all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP. Here “Number of subjects analyzed” signifies those subjects who were evaluable for this outcome measure.|||beats per minute||Standard Deviation|Mean
2617608|NCT01977794|Secondary|Percentage of Subjects With Controlled Blood Pressure||Baseline up to Week 18|MITT analysis set included all randomized and treated subjects with at least 1 SBP measurement after the date of first dose of IMP.|||percentage of subjects|||Number
2617613|NCT01977781|Secondary|Tear Film Break-Up Time|Tear Film Break-Up Time measures the amount of time, in seconds, that the tear film completely coats the ocular surface after each blink. The longer the amount of time the tear film completely coats the ocular surface is considered to be better than a shorter amount of time.|10 weeks|Measurements are reported from the 10 week study visit. At this time 3 subjects were lost to follow-up and 4 subjects dropped out of the study due to burning sensations. 3 subjects dropped out from the Tacrolimus arm and 1 subject dropped out of the Methylprednisolone arm.|||Seconds||Standard Deviation|Mean
2617614|NCT01977781|Secondary|Schirmer Tear Test (mm)|Schirmer tear test measures the amount of tear secretion produced by a patient in millimeters (mm). Generally, the greater amounts of tear secretion is better than smaller amounts of tear secretion. The minimum value of this scale is 0 mm of tear secretion and there is no maximum value to this scale.|10 weeks|Measurements are reported from the 10 week study visit. At this time 3 subjects were lost to follow-up and 4 subjects dropped out of the study due to burning sensations. 3 subjects dropped out from the Tacrolimus arm and 1 subject dropped out of the Methylprednisolone arm.|||millimeter (mm)||Standard Deviation|Mean
2617615|NCT01977781|Secondary|Corneal Epitheliopathy (Corneal Fluorescein Staining Using the NEI Grading Scheme)|Corneal fluorescein staining is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The corneal fluorescein staining scale ranges from 0 to 15, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.|10 weeks|Measurements are reported from the 10 week study visit. At this time 3 subjects were lost to follow-up and 4 subjects dropped out of the study due to burning sensations. 3 subjects dropped out from the Tacrolimus arm and 1 subject dropped out of the Methylprednisolone arm.|||units on a scale||Standard Deviation|Mean
2617616|NCT01977781|Secondary|Ocular Surface Disease Index (OSDI) Questionnaire|The OSDI questionnaire is a 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate each of the dry eye symptoms on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.|10 weeks|Measurements are reported from the 10 week study visit. At this time 3 subjects were lost to follow-up and 4 subjects dropped out of the study due to burning sensations. 3 subjects dropped out from the Tacrolimus arm and 1 subject dropped out of the Methylprednisolone arm.|||units on a scale||Standard Deviation|Mean
2617617|NCT01977781|Primary|Ocular Burning Sensation, Ocular Discharge, Ocular Redness, Ocular Itching, Foreign Body Sensation|Ocular burning sensation, ocular discharge, ocular redness, ocular Itching, and foreign body sensation were measured to evaluate the safety and tolerability of topical tacrolimus 0.05% twice a day in the treatment of patients with ocular GVHD. Safety and tolerability of topical tacrolimus 0.05% twice a day will be monitored by the occurrence of systemic and ocular adverse events in addition to symptoms directly related to the instillation or use of the investigational medication. Subjects will be monitored at each study visit for the occurrence of any adverse events found through examination or patient reports. Tolerability will be evaluated at every visit with a self-response questionnaire that assessed burning sensation, discharge, redness, itchiness, and foreign body sensation on a scale from 0 to 4 (none = 0, trace = 1, mild = 2, moderate = 3, and severe = 4). Where a higher value represents more symptoms (less tolerability).|10 weeks|The results are taken from the week 10 study assessment|||units on a scale||Standard Deviation|Mean
2617618|NCT01977729|Other Pre-specified|Positive and Negative Affect Scale for Children|Positive and Negative Affect Scale for Children (PANAS-C). Negative affect (NA) will be assessed using the NA subscale on the PANAS-C. The 15 NA items (e.g., sad, miserable) on the 27-item PANAS-C are scored 1 (very slightly or not at all) to 5 (extremely). Higher scores in the NA subscale indicate higher levels of negative affect.|20 weeks from enrollment|No data collected.||||||
2617619|NCT01977729|Secondary|Multidimensional Anxiety Scale for Children|Multidimensional Anxiety Scale for Children (MASC-2; Self-report and Parent completed). Treatment outcome will be assessed on a specific symptom level from the youth's and parent's perspective using the MASC-2. The MASC-2 consists of 50 items across 5 factors: Separation Anxiety/Phobias, Generalized Anxiety Disorder, Social Anxiety, Obsessions & Compulsions, and Harm Avoidance. MASC T-scores less than 65 indicate the child is no longer in the clinical range of anxiety symptoms.|20 weeks from enrollment|Study was terminated before randomization.||||||
2617620|NCT01977729|Primary|Clinical Global Impression Severity & Improvement Scales|Youth outcome will be assessed on a global level using the Clinical Global Impression (CGI) Severity Scale, ranging from 1 (not at all) to 7 (among the most extremely ill patients). Higher ratings indicate greater anxiety symptom severity. The CGI Improvement Scale ranges from 1 (very much improved) to 7 (very much worse). Lower ratings indicate greater improvement on anxiety symptom severity. A CGI Improvement Scale rating of 1 or 2 indicates clinically meaningful improvements in anxiety symptom severity.|20 weeks from enrollment|Medication was never given, and tests were never done.||||||
2617621|NCT01977690|Primary|Average Neck Pain Level|Patients self-recorded their average level of pain on a scale from 1 to 10 for each post-surgery day beginning on postoperative day 2. 1 Meaning least pain, 10 meaning worst level of pain|1 month|4 participants in the Clavicle brace group did not tolerate the brace and are included in the standard management group for this analysis. Only participants will available data are included in the analysis.|||units on a scale (VAS pain scale)||Standard Deviation|Mean
2617622|NCT01977677|Primary|Participants Alive and Without Disease Progression At 6 Months After the Start of the Irradiation|Progression free survival based on the Response Assessment for Neuro-Oncology (RANO) criteria, using both clinical examinations and MRIs with and without contrast summarized with Kaplan Meier estimates.|6 months from start of irradiation||||Participants|||Count of Participants
2617623|NCT01977677|Primary|Dose-limiting Toxicity|Dose Limiting Toxicity is defined as defined as any hematologic or on-hematologic adverse events grade 3 or higher using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 with a suspected causal relationship to Plerixafor (including electrocardiogram changes indicative of ischemia, ventricular tachycardia)|Up to 30 days post plerixafor||||Participants|||Count of Participants
2617625|NCT01977625|Primary|Percent Change in Blood Oxygen Level Dependent (BOLD) Signal|Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. BOLD signals were compared from baseline, first intervention and second intervention.|10 weeks|All participants who completed all phases of the study were included in the outcome analysis.|||percent change||Standard Deviation|Mean
2617626|NCT01977612|Secondary|Median Patient Satisfaction Score of Scar Appearance|"Patients will be asked to rate the general appearance, location and comfort of the scar. This was collected as a continuous variable. Patients were given a paper survey and asked to please draw a single slash across a provided line indicating how satisfied they were with the appearance of their scar. The beginning of the line was designated very unsatisfied or 0% and the end of the line was very satisfied or 100%."|4-8 weeks post-operative|-Data was not collected on 13 patients in the Stainless Steel Staple arm and 12 patients in the 4-0 Monocryl Suture arm|||Patient Satisfaction Score||Inter-Quartile Range|Median
2617627|NCT01977612|Secondary|Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score|"Ranges from 0 (worst) to 5 (best)~Sum of width, height, color, hatch, and overall appearance where a better outcome has a value of 5 and a worse outcome has a value of 0"|4-8 weeks post-operative|-Data was not collected from 10 patients in the Stainless Steel Staple arm and 9 patients in the 4-0 Monocryl Suture arm|||units on a scale||Inter-Quartile Range|Median
2617628|NCT01977612|Secondary|Analog Pain Score on Postoperative Days 3-4|The highest pain score as recorded by nursing staff at a minimum of every 8 hours between 72-96 hours postoperatively.|3-4 days post-surgery|Data was not collected from any patients for this outcome measure||||||
2617629|NCT01977612|Secondary|Operative Time|Time from skin incision to the end of skin closure|During surgery|Data was not collected from 3 patients in the stainless steel staple arm and 1 patient in the 4-0 Monocryl suture arm|||minutes||Inter-Quartile Range|Median
2617630|NCT01977612|Secondary|Incidence of Wound Infection|Purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection.|4-8 weeks post-surgery||||Participants|||Count of Participants
2617631|NCT01977612|Secondary|Incidence of Wound Disruption||4-8 weeks post-surgery|-Data on incidence of wound disruption was not collected on 9 patients in the stainless steel staple arm and 9 patients in the 4-0 Monocryl suture arm.|||Participants|||Count of Participants
2617632|NCT01977612|Primary|Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery.||4-8 weeks post-surgery||||Participants|||Count of Participants
2617633|NCT01977573|Secondary|Number of Weeks Dose Withheld Because Hemoglobin (Hgb) Exceeded the Upper Limit|Number of Weeks dose was withheld because hemoglobin exceed the upper limit is presented as the number of participants with withheld dose during the time periods categorized by Weeks.|From Week 4 up to Week 24|ITT population.|||participants|||Number
2617634|NCT01977573|Secondary|Number of Participants Receiving Additional Therapies of Blood Transfusions, Intravenous (IV) Iron or rhEPO at Any Time Post-Baseline|Participants receiving additional therapies of blood transfusions, intravenous (IV) iron or rhEPO any time Post Baseline were analyzed. RhEPO was not applicable for the control arms since it was a planned therapy in those arms, hence presented as NA. (EudraCT only: A value of 99999 is used where no data is available or NA.)|From Day 1 up to Week 28|ITT Population|||participants|||Number
2617635|NCT01977573|Secondary|Number of Participants With at Least One Dose Cycle up to 24 Weeks|A dose cycle is a series of three directional dose changes (that is, increase, decrease, increase; or decrease, increase, decrease). participants|Up to 24 weeks|Completers population. Only participants in the GSK1278863 arms with dose cycles were analyzed.|||participants|||Number
2617636|NCT01977573|Secondary|Number of Participants With at Least One Hemoglobin (Hgb) Cycle up to 24 Weeks|A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter. A Hgb cycle is two consecutive Hgb excursions in different directions.|Up to 24 weeks|Completers population.|||participants|||Number
2617637|NCT01977573|Secondary|Number of Participants With at Least One Hemoglobin (Hgb) Excursion up to 24 Weeks.|A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter.|Up to 24 weeks|Completers population.|||participants|||Number
2617638|NCT01977573|Secondary|Number of Dose Cycles up to 24 Weeks|A dose cycle is a series of three directional dose changes (that is, increase, decrease, increase; or decrease, increase, decrease).|Up to 24 weeks|Completers population. Only participants in the GSK1278863 arms with dose cycles were analyzed.|||number|||Number
2617639|NCT01977573|Secondary|Number of Hemoglobin (Hgb) Cycles up to 24 Weeks|A Hgb cycle is calculated as two consecutive Hgb excursions in different directions. A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter.|Up to 24 Weeks|Completers population. Only participants with Hgb cycles were analyzed.|||number of Hgb cycles|||Number
2617640|NCT01977573|Secondary|Number of Hemoglobin (Hgb) Excursions|A Hgb excursion is a series of decreasing or increasing Hgb values differing by >=1.5 grams per deciliter. Hgb cycle is calculated as two consecutive Hgb excursions in different directions.|Up to 24 Weeks.|Completers Population: ITT participants who fully completed study without prematurely discontinuing study drug. Only participants with Hgb excursions were analyzed.|||number of excursions|||Number
2617641|NCT01977573|Secondary|Mean Final Dose of GSK1278863 up to 24 Weeks|The starting dose was kept constant for the first 4 Weeks after randomization. Later, the need to adjust the dose of GSK1288863 was evaluated at every scheduled visit according to a pre-specified algorithm, to achieve and maintain hemoglobin within the specified target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.|Up to 24 Weeks|ITT population.|||milligrams per day||Standard Deviation|Mean
2617642|NCT01977573|Secondary|Mean Total Cumulative Dose of GSK1278863 up to 24 Weeks|The starting dose was kept constant for the first 4 Weeks after randomization. Later, the need to adjust the dose of GSK1288863 was evaluated at every scheduled visit according to a pre-specified algorithm, to achieve and maintain hemoglobin within the specified target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.|Up to 24 Weeks|ITT population.|||milligrams||Standard Deviation|Mean
2617643|NCT01977573|Secondary|Timing of Dose Adjustments at Weeks 4, 8, 12, 16, and 20|After 4 Weeks, the need to adjust the dose of GSK1278863 was evaluated at every scheduled visit, to maintain hemoglobin within the target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. Dose adjustments were assigned automatically via the interactive voice/web response system. The number of participants with an adjustment are presented at the timings at which adjustments were done.|From Week 4 up to Week 20|ITT population. Only those participants with at least one dose adjustment of GSK1278863 were analyzed.|||Participants|||Number
2617644|NCT01977573|Secondary|Number of Participants With Dose Adjustments up to 24 Weeks, as a Measure of Dose Adjustment Frequency|After 4 Weeks, the need to adjust the dose of GSK1278863 was evaluated at every scheduled visit, to maintain hemoglobin within the target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. Dose adjustments were assigned automatically via the interactive voice/web response system. Frequency is presented as the number of participants with dose adjustment(s) once, twice, thrice, four times, or five times.|From week 4 up to 24 weeks|Intent-to-Treat population. Only those participants with at least one dose adjustment of GSK1278863 were analyzed.|||participants|||Number
2617645|NCT01977573|Secondary|Mean Number of Dose Adjustments up to 24 Weeks|After 4 Weeks, the need to adjust the dose of GSK1278863 was evaluated at every scheduled visit, to maintain hemoglobin within the target range. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL. Dose adjustments were assigned automatically via the interactive voice/web response system.|From Week 4 up to 24 Weeks|Intent-to-Treat population. Only those participants with at least one dose adjustment of GSK1278863 were analyzed.|||number of adjustments||Standard Deviation|Mean
2617646|NCT01977573|Secondary|Concentration of GSK1278863 and Relevant Metabolites as a Population Pharmacokinetic Endpoint|Blood samples were collected for individual plasma GSK1278863 and metabolite (GSK2391220, GSK2487818, GSK2506102, GSK2531398, GSK2531401, and GSK2531403) concentration measurement on Day 1 (pre-dose), Wk 4 (6-12 hour, 7-13 hour, 8-14 hour, 9-15 hour post-dose), and Wk 20 (pre-dose, 1 hour, 2 hour, 3 hour post-dose). Participants available in each arm at the specified time points have been presented.|Day 1 (pre-dose), Week (Wk) 4 (6-12 hour, 7-13 hour, 8-14 hour, 9-15 hour post-dose), and Wk 20 (pre-dose, 1 hour, 2 hour, 3 hour post-dose)|Pharmacokinetics (PK) population: All participants from whom a PK sample was obtained and analyzed. This population did not include participants from the control groups.|||nanograms per milliliter||Standard Deviation|Mean
2617647|NCT01977573|Secondary|Change From Baseline in Reticulocyte Cell Count at Week 24|Reticulocyte count is a blood test that measures the percentage of reticulocytes in the blood. Reticulocytes are slightly immature red blood cells. Baseline is the last pre-dose red reticulocyte count. Change from Baseline in reticulocyte cell count was calculated by subtracting the Baseline count from the Week 24 count.|Baseline and Week 24|ITT population. Only participants with data available at specific timepoint were analyzed.|||percentage of reticulocytes||Standard Deviation|Mean
2617648|NCT01977573|Secondary|Change From Baseline in Red Blood Cell Count at Week 24|Baseline is the last pre-dose red blood cell count. Change from Baseline in red blood cell count was calculated by subtracting the Baseline count from the post-dose count.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.|||10^12 cells per liter||Standard Deviation|Mean
2617649|NCT01977573|Secondary|Change From Baseline in Hematocrit at Week 24|Baseline is the last pre-dose hematocrit value. Change from Baseline was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with data available at specific timepoint were analyzed.|||percentage change in Fraction of 1||Standard Deviation|Mean
2617650|NCT01977573|Secondary|Change From Baseline in Reticulocyte Hemoglobin (CHr) at Week 24|Reticulocytes are slightly immature red blood cells. Reticulocyte Hgb content is used to differentiate iron deficiency from other causes of anemia. Baseline is the last pre-dose CHr value. Change from Baseline in reticulocyte Hgb was calculated by subtracting the Baseline value from the post-dose value.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.|||picogram||Standard Deviation|Mean
2617651|NCT01977573|Secondary|Change From Baseline in Total Iron Binding Capacity (TIBC) at Week 24|TIBC measures the blood's capacity to bind iron with transferrin. Baseline is the last pre-dose TIBC value. Change from Baseline in TIBC was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with data available at specific timepoint were analyzed.|||micromoles per liter||Standard Deviation|Mean
2617652|NCT01977573|Secondary|Change From Baseline in Total Iron at Week 24|Baseline is the last pre-dose total iron value. Change from Baseline was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with available total iron values at Baseline and Week 24 were analyzed.|||micromoles per liter||Standard Deviation|Mean
2617653|NCT01977573|Secondary|Percent Change From Baseline in Transferrin Saturation at Week 24|Transferrin saturation is measured as a percentage; it is a ratio of serum iron and total iron-binding capacity. Baseline is the last pre-dose transferrin saturation value. Percent change was calculated as 100 multiplied by (exponential of mean change on log scale minus 1). Change was calculated by subtracting the Baseline value from the post-dose value.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.|||percent change||95% Confidence Interval|Geometric Mean
2617654|NCT01977573|Secondary|Change From Baseline in Transferrin Concentration at Week 24|Baseline is the last pre-dose transferrin value. Change from Baseline in transferrin was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.|||grams per liter||Standard Deviation|Mean
2617655|NCT01977573|Secondary|Change From Baseline in Ferritin Concentration at Week 24|Baseline is the last pre-dose ferritin value. Change was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|ITT population. Only participants with data available at specific time point were analyzed.|||micrograms per liter||Standard Deviation|Mean
2619518|NCT01963091|Secondary|Likert Scale Rating of Subjective Stress|Subjects will rate subjective stress on 10-point Likert scale with 0 being 'not at all' and 10 being 'extremely'|0 minutes post 15 minute stress task||||units on a scale||Standard Deviation|Mean
2617656|NCT01977573|Secondary|Percentage of Time Within, Below, and Above Hemoglobin (Hgb) Target Range, Between Weeks 12 and 24|The number of days a participant's Hgb was within target range was calculated by estimating (using linear interpolation) the number of days within target range between two scheduled Hgb visits. Percentage of time within range for a participant was calculated by dividing the total number of days that Hgb was within range during Weeks 12 to 24 by the total number of days the participant remained on treatment during Weeks 12 to 24. Similary, percent of time above and below Hgb target range was calculated. Target range was defined as: Original Hgb Criteria of 9.0 to 10.5 g/dL, and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.|Weeks 12 to 24|ITT population. Only participants with data available at specific time points were analyzed.|||percentage of days||Standard Deviation|Mean
2617657|NCT01977573|Secondary|Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)|Blood samples for control arm were collected pre-dose for VEGF measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose ), Week 4 (6-12 hours post-dose ), Week 4 (7-13, 8-14, 9-15, hours post-dose ), Week 8 (pre -dose ), Week 12 (pre -dose ), Week 16 (pre -dose ), Week 20 (pre -dose , 3 hour post-dose ) Week 24 (pre -dose ), and Week 28 (pre -dose ) for VEGF measurement. The maximum observed change from baseline in VEGF was recorded for each arm . Baseline value for VEGF is the pre-dose value on Day 1. Change from Baseline in VEGF was calculated as the individual post-baseline values minus the Baseline value.|Baseline and up to Week 24|ITT population. Only participants with data available at Baseline and a maximum observed change were analyzed.|||percent change in VEGF concentration||95% Confidence Interval|Geometric Mean
2617658|NCT01977573|Secondary|Maximum Observed Change From Baseline in Serum Erythropoietin (EPO)|Blood samples for control arm were collected pre-dose for EPO measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose ), Week 4 (6-12 hours post-dose ), Week 4 (7-13, 8-14, 9-15, hours post-dose ), Week 8 (pre -dose ), Week 12 (pre -dose ), Week 16 (pre -dose ), Week 20 (pre -dose , 3 hour post-dose ) Week 24 (pre -dose ), and Week 28 (pre -dose ) for EPO measurement. The maximum observed change from baseline in EPO was recorded for each arm. Baseline value for EPO is the pre-dose value on Day 1. Change from Baseline in EPO was calculated as the individual post-baseline values minus the Baseline value.|Baseline to Week 24|ITT population. Only participants having a Baseline EPO measurement and at least one post-baseline EPO measurement were analyzed.|||International Units per liter||Standard Deviation|Mean
2617659|NCT01977573|Secondary|Percent Change From Baseline in Hepcidin Concentration at Week 24|Baseline is the last pre-dose hepcidin value. Percent change was calculated as 100 multiplied by (exponential of mean change on log scale minus 1). Change was calculated by subtracting the Baseline value from the Week 24 value.|Baseline and Week 24|Intent-to-Treat (ITT) population consisted all randomized participants who received at least one dose of study drug, had a Baseline and at least one corresponding on-treatment assessment. Only participants with available hepcidin values at Baseline and Week 24 were analyzed.|||percent change in Hepcidin||95% Confidence Interval|Geometric Mean
2617660|NCT01977573|Secondary|Number of Participants Reaching Pre-defined Hgb Stopping Criteria|The Hgb stopping criteria was a value of <7.5 mg/dL obtained on-site via a validated point-of-care Hgb measurement device, which necessitated permanent discontinuation of the study medication. None of the participants met the stopping criteria therefore there is no data to present for this outcome measure.|Over a period of 24 Weeks|ITT population.|||Participants|||Number
2617661|NCT01977573|Secondary|Number of Participants With Hemoglobin (Hgb) in the Target Range at Week 24|Target range is defined as: Original Hgb Criteria of 9.0 to 10.5 gram/deciliter (g/dL), and Amended Hgb Criteria of 10.0 to 11.5 g/dL. Sites in the USA used 9.0 to 10.5 g/dL.|Week 24|ITT population. Only participants who were available at the indicated time point were analyzed.|||participants|||Number
2617662|NCT01977573|Primary|Summary of Hemoglobin (Hgb) Concentration at Week 24|"The original Hgb Criteria for Group 1- rhEPO naive participants with a stable baseline Hgb of 8.0-10.0 g/dL (8.0-10.0 g/dL USA site only) and for Group 2- rhEPO users with a stable baseline Hgb of 9.0-10.5 g/dL (9.0-10.5 g/dL USA site only); the Hgb target range was 9.0 to 10.5 g/dL (9.0-10.5 g/dL USA site only). The study amended Hgb Criteria for Group 1- rhEPO naive participants with a stable baseline Hgb of 8.0-11.0 g/dL and Group 2- rhEPO users with a stable baseline Hgb of 9.0-11.5 g/dL; Hgb target range - 10.0 to 11.5 g/dL. Data are presented for those participants following the original criteria (Original) and those following the amended (Amended) criteria. The primary objective was to characterize the ability of GSK1278863 to achieve mean Hgb response within the target range."|Week 24|Intent-to-Treat (ITT): The ITT population consisted of all randomized participants who received at least one dose of study drug, had a Baseline and at least one corresponding on-treatment assessment. Only participants who were available at the indicated time point were analyzed.|||grams per deciliter||Standard Deviation|Mean
2617663|NCT01977482|Secondary|Change From Baseline in Reticulocyte Count at Week 24|A reticulocyte count is a blood test that measures the percentage of reticulocytes in the blood. Reticulocytes are slightly immature red blood cells. Baseline value for reticulocyte count is the pre-dose value on Day 1. Change from Baseline in reticulocyte count was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||Percentage of reticulocytes in blood||Standard Deviation|Mean
2617664|NCT01977482|Secondary|Change From Baseline in Red Blood Cells at Week 24|Baseline value for red blood cells is the pre-dose value on Day 1. Change from Baseline in red blood cells was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||10^12 cells/Liter||Standard Deviation|Mean
2617665|NCT01977482|Secondary|Change From Baseline in Hematocrit at Week 24|Hematocrit is the ratio of the volume of red blood cells to the total volume of blood. Baseline value for hematocrit is the pre-dose value on Day 1. Change from Baseline in hematocrit was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||Ratio||Standard Deviation|Mean
2617666|NCT01977482|Secondary|Change From Baseline in Reticulocyte Hemoglobin at Week 24|Baseline value for reticulocyte hemoglobin is the pre-dose value on Day 1. Change from Baseline in reticulocyte hemoglobin was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||Picogram||Standard Deviation|Mean
2617667|NCT01977482|Secondary|Change From Baseline in Total Iron Binding Capacity at Week 24|Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline value for total iron binding capacity is the pre-dose value on Day 1. Change from Baseline in total iron binding capacity was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||Micromoles/Liter||Standard Deviation|Mean
2617668|NCT01977482|Secondary|Change From Baseline in Total Iron at Week 24|Baseline value for total iron is the pre-dose value on Day 1. Change from Baseline in total iron was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||Micromoles/Liter||Standard Deviation|Mean
2617669|NCT01977482|Secondary|Percent Change From Baseline in Transferrin Saturation at Week 24|Transferrin saturation is measured as a percentage, it is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change from Baseline =: 100*(exp(Mean change log scale)-1).|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||Percent change||95% Confidence Interval|Geometric Mean
2617670|NCT01977482|Secondary|Change From Baseline in Transferrin at Week 24|Baseline value for transferrin is the pre-dose value on Day 1. Change from Baseline in transferrin was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||grams (g)/Liter (L)||Standard Deviation|Mean
2617671|NCT01977482|Secondary|Change From Baseline in Ferritin at Week 24|Baseline value for ferritin is the pre-dose value on Day 1. Change from Baseline in ferritin was calculated as the Week 24 value minus the Baseline value.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||Micrograms/Liter||Standard Deviation|Mean
2617672|NCT01977482|Secondary|Percent Change From Baseline in Hepcidin at Week 24|Hepcidin is a regulator of iron metabolism. Baseline value for transferrin saturation is the pre-dose value on Day 1. Percent change from Baseline was calculated as 100 multiplied by exponential of mean change in log scale minus 1.|Baseline (Day 1) and Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||Percent change||95% Confidence Interval|Geometric Mean
2617673|NCT01977482|Secondary|Population Plasma PK Parameters of GSK1278863 and Metabolites|Blood samples were collected for individual plasma GSK1278863and metabolite (GSK2391220, GSK2499166, GSK2531403, GSK2531400, GSK2531399, and GSK2531398) concentrations measurement on Day (D) 1 (pre-dose [PrD), at Week (W) 4 (6-12, 7-13, 8-14, and 9-15 hour [hr] post-dose [PoD), and at W20 (PrD, 1, 2, and 3 hour PoD). Pharmacokinetic population: All participants from whom a PK sample has been obtained and analyzed.|Day 1, Week 4, and Week 20|Pharmacokinetic Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points; thus, the overall number of participants analyzed reflects everyone in the pharmacokinetic population|||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
2617674|NCT01977482|Secondary|Maximum Observed Percent Change From Baseline in Vascular Endothelial Growth Factor (VEGF)|Blood samples for control arm were collected on Day 1 (pre-dose), Week 4 (5-15 minutes post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 5-15 minutes post-dose), Week 24 (pre-dose), and Week 28 (pre-dose) for VEGF measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose), Week 4 (7-13, 8-14, 9-15, hours post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 3 hour post-dose) Week 24 (pre-dose), and Week 28 (pre-dose) for VEGF measurement. The maximum observed percent change from Baseline in VEGF was recorded for each arm. Baseline value for VEGF is the pre-dose value on Day 1. Percent change from Baseline was calculated as 100 multiplied by exponential of mean change in log scale minus 1.|Baseline (Day 1) to Week 28|ITT Population. Only participants with data available at specific time point were analyzed.|||Percent change||95% Confidence Interval|Geometric Mean
2617675|NCT01977482|Secondary|Maximum Observed Change From Baseline in Erythropoietin (EPO)|Blood samples for control arm were collected on Day 1 (pre-dose), Week 4 (5-15 minutes post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 5-15 minutes post-dose), Week 24 (pre-dose), and Week 28 (pre-dose) for EPO measurement. Blood samples for GSK1278863 arms were collected on Day 1 (pre-dose), Week 4 (6-12 hours post-dose), Week 4 (7-13, 8-14, 9-15, hours post-dose), Week 8 (pre-dose), Week 12 (pre-dose), Week 16 (pre-dose), Week 20 (pre-dose, 3 hour post-dose) Week 24 (pre-dose), and Week 28 (pre-dose) for EPO measurement. The maximum observed change from baseline in EPO was recorded for each arm. Baseline value for EPO is the pre-dose value on Day 1. Change from Baseline in EPO was calculated as the individual post-dose values minus the Baseline value.|Baseline (Day 1) to Week 28|ITT Population. Only participants with data available at specific time point were analyzed.|||international units(IU)/Liter (L)||Standard Deviation|Mean
2617676|NCT01977482|Secondary|Number of Participants Reaching Pre-defined Hgb Stopping Criteria|The number of participants who reached the Hgb stopping criteria of Hgb concentration <7.5 g/dL were presented.|Up to 24 weeks|ITT Population|||Participants|||Number
2617677|NCT01977482|Secondary|Number of Participants With Hgb in the Target Range at Week 24|The number of participants with Hgb in the target range of 10.0 to 11.5 g/dL at Week 24 was recorded for each arm.|Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||Participants|||Number
2617678|NCT01977482|Secondary|Percentage of Time Within, Below, and Above Hgb Target Range Between Weeks 20 and 24|The percentage of time in Hgb target range between Weeks 20 and 24 for a participant was calculated by dividing the total number of days that Hgb was within the target range (10.0 to 11.5 g/dL) while on treatment during Weeks 20 to 24 (using linear interpolation) by the total number of days the participant remained on treatment during the defined period. Similarly, percentage of time above Hgb target range and percentage of time below Hgb target range were calculated.|Week 20 to Week 24|ITT population. Only participants with data available at specific timepoint were analyzed.|||Percentage of days||Standard Deviation|Mean
2617679|NCT01977482|Secondary|Hgb Concentration at Week 24|Hgb values measured at Week 24 are presented.|Week 24|ITT Population. Only participants with data available at specific time point were analyzed.|||g/dL||Standard Deviation|Mean
2617680|NCT01977482|Primary|Change From Baseline in Hemoglobin (Hgb) at Week 4|Baseline Hgb value was the average of three Hgb values taken during screening period at Week (W) -4, W-2 and Day 1. Change from Baseline in Hgb was calculated as W4 value minus the Baseline value. To model the dose-response relationship a four-parameter Emax model was used. The dose response dataset was based on all non-missing data collected up to W4. Participants (par.) who had a Week 2 Hgb measurement, but a missing Week 4 Hgb measurement were included with a change from Baseline at Week 4 value imputed as twice the change from Baseline at Week 2. E0 is the expected Hgb change from Baseline for a par. receiving placebo and experiencing the average Hgb Baseline observed in the study. Emax is the expected Hgb change from Baseline for a par. receiving the highest dose above which no further increase in response can be achieved. ED50 is the dose that attains the intermediate response. Gamma is the slope parameter. Alpha is the coefficient of the model covariate for centred Baseline.|Baseline (Week -4, Week-2 and Day 1) and Week 4|ITT Population. Only participants with data available at specific time point were analyzed.|||grams (g)/deciliter (dL)||Standard Deviation|Mean
2617681|NCT01977456|Other Pre-specified|The Number of Participants With Good Outcomes According to the Modified Rankin Score.|Modified Rankin score (mRS) dichotomized to good outcome (mRS 0-1 or return to baseline), poor outcome (all others including death). Results reported are good outcome.|90 days from the date of stroke onset||||participants|||Number
2617682|NCT01977456|Secondary|The Number of Patients Who Develop Parenchymal Hemorrhage Types 1( PH-1) and 2 (PH-2).|Any parenchymal hemorrhage types PH-1 or PH-2 as visualized on CT|within 36 hours after stroke onset||||participants|||Number
2617683|NCT01977456|Secondary|The Number of Patients Who Experience Any Intracerebral Hemorrhage (ICH).|Any ICH symptomatic (as defined above) or asymptomatic (that visualized on CT or MRI only)|within 36 hours after stroke onset||||participants|||Number
2617684|NCT01977456|Primary|The Number of Patients Who Experience Symptomatic Intracerebral Hemorrhage (sICH).|Any ICH related to a decline in neurologic status or the development of new neurologic symptoms which in the judgment of the clinical investigator was related to the ICH. Judgment of significant neurological decline was made by the local clinical investigator|within 36 hours after stroke onset||||participants|||Number
2617685|NCT01977352|Secondary|Sleep Quality|scale of 0-10, 0=horrible, up all night; 10=perfect sleep|Post op Day 1, post op Day 2, post op day 3, post op 1 week||||units on a scale||Standard Deviation|Mean
2617686|NCT01977352|Secondary|Incidence of Postoperative Nausea and Vomiting||72 hours||||percentage of participants|||Number
2617687|NCT01977352|Secondary|Time to Discharge Home|data not collected|72 hours|||||||
2617688|NCT01977352|Secondary|Time to First Pain Medicine||72 hours||||minutes||Standard Deviation|Mean
2617689|NCT01977352|Secondary|Sensory and Motor Block|Measurement of brachial plexus blockade upon completion of the peripheral nerve block and prior to surgery. Sensory block will be assessed by pinprick with a paper clip using a 1-3 scale: 1, no block (complete sensation); 2, parasthesia (light touch); 3, anesthesia (no sensation). Motor block uses the same 1-3 scale: 1 = no block, 2= parasthesia and 3=anesthesia. Evaluation of sensory block will also be undertaken at one after arrival to the Post Anesthesia Care Unit (PACU). The first occurrence of pain perceived by the patient will be used as a surrogate for return of the sensory function.|at 20 min and at 1 hour||||units on a scale||Standard Deviation|Mean
2617690|NCT01977352|Secondary|Quality of Analgesia|The Numeric Rating Scale (NRS-11) is an 11-point scale, from 0 = no pain to 10 = Severe Pain, for patient self-reporting of pain.|Post op Day 1, post op Day 2, post op day 3, post op 1 week||||units on a scale||Standard Deviation|Mean
2617691|NCT01977352|Primary|Total Opioid Consumption|Compare total opioid consumption up to 1 week post operatively between patients receiving bupivacaine 0.25% (20 cc) and liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc) for interscalene brachial plexus block.|Post op Day 1, post op Day 2, post op day 3, post op 1 week||||number of percocet tabs||Standard Deviation|Mean
2617692|NCT01977222|Other Pre-specified|Change in VE/VCO2 Slope (Ratio) During Exercise||Baseline and after 12 weeks of training||||ratio||Standard Deviation|Mean
2617693|NCT01977222|Other Pre-specified|Change in Peak Work Rate During Exercise||Baseline and after 12 weeks of training||||Watts||Standard Deviation|Mean
2617694|NCT01977222|Other Pre-specified|Change in Oxygen Pulse at Peak Exercise||12 weeks||||mL/beat||Standard Deviation|Mean
2617695|NCT01977222|Other Pre-specified|Change in Maximal Inspiratory Pressure||Baseline and after 12 weeks of training||||cmH2O||Standard Deviation|Mean
2617696|NCT01977222|Other Pre-specified|Change in Maximum Voluntary Ventilation||12 weeks||||L/min||Standard Deviation|Mean
2617697|NCT01977222|Secondary|Change in SF-36 Health Survey Score (Physical Component Summary)|The 36-Item Short Form (SF-36) Health Survey is a disease-generic survey of an individual's perceived health status and health-related quality of life. There are eight scaled scores, which are the weighted sums of the questions in their section. Each scale is transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. These eight scales are then used to calculate (using a proprietary formula) two summary scores: the physical component score (PCS), representing the four physical health scales (physical functioning, role physical, bodily pain, general health), and the mental component score (MCS), representing the four mental health scales (mental health, role emotional, vitality, social functioning). Component scores are norm-based with a mean of 50 (standardized to the US population) and a standard deviation of 10.|12 weeks||||units on a scale||Standard Deviation|Mean
2617698|NCT01977222|Secondary|Change in Innocor Measurement (Inert Gas Rebreathing Method) of Cardiac Output at Peak Exercise||12 weeks|One individual failed to sustain maximal exercise long enough to complete measurement of cardiac output on her post-intervention study. That individual was therefore left out of the data analysis for cardiac output at peak exercise ONLY.|||L/min||Standard Deviation|Mean
2617699|NCT01977222|Primary|Change in Peak VO2 Between Baseline and Post-inspiratory Muscle Training Measurements.||Baseline and after 12 weeks of training||||ml/kg/min||Standard Deviation|Mean
2617700|NCT01977092|Primary|Change in Worries About HIV in Past 6 Months.|Measured by whether or not the participant was worried about HIV in past 6 months.|Baseline, 6 months, and 12 months|330 participants were interviewed at baseline. We attempted to follow up with all participants, whether or not they stayed at the sober living house, for 6 and 12 month follow up interviews. We were not able to find all of them for follow up interviews.|||Participants|||Count of Participants
2617701|NCT01977092|Primary|Change in Alcohol and Drug Use (Timeline Follow Back)|Measured by whether or not the participant reports complete abstinence from all substance use for last 6 months on Timeline Followback (TLFB).|Baseline, 6 months, and 12 months|330 participants were interviewed at baseline. We attempted to follow up with all participants, whether or not they stayed at the sober living house, for 6 and 12 month follow up interviews.|||Participants|||Count of Participants
2617702|NCT01977092|Primary|Change in Criminal Justice Outcomes|Measured by dichotomous measure of whether or not any time spent incarcerated in past 6 months.56 follow-up interviews were conducted in jails, when allowed and the participant was comfortable, but we did not conduct interviews in prison. See participant flow for number of participants in prison.|Baseline, 6 months, and 12 months|330 participants were interviewed at baseline. We attempted to follow up with all participants, whether or not they stayed at the sober living house, for 6 and 12 month follow up interviews. We were not able to find all of them for follow up interviews.|||Participants|||Count of Participants
2617703|NCT01977040|Primary|Gestational Age of Infant at Birth|Gestational age of the infant noted in weeks at the time of birth|At birth.|Mean Gestational age at delivery as well as Mean Gestational Age for those patients who delivered emergently and non-emergent are presented.|||weeks||Standard Deviation|Mean
2617704|NCT01977040|Primary|Mode of Delivery Stratified by Diagnostic Profile.|Mode of delivery (C/S - emergent, non-emergent, vaginal) stratified by diagnostic profile|At birth.||||Participants|||Count of Participants
2617705|NCT01977040|Primary|Gestational Age at Time of Diagnosis Stratified by Diagnostic Profile.||Participants will be followed from time of diagnosis of vasa previa during the second trimester up until delivery.|Only 64 participants had vasa previa diagnosed via ultrasound during the antenatal period.|||weeks||Full Range|Mean
2617706|NCT01977040|Primary|Diagnostic Profile of Techniques Utilized to Screen for and Diagnose Vasa Previa During Pregnancy.|The primary outcome of the study it to describe antenatal techniques utilized to screen for and diagnose vasa previa. Vasa previa is when unprotected blood vessels implanted in the membranes or sac run from the placenta across the inside of the woman's cervix. Antepartum ultrasounds were conducted according to standard of care. Here we report the count of participants who were diagnosed during routine ultrasound exam. After initial diagnosis by ultrasound, Vasa Previa's were followed up by routine ultrasounds for confirmation prior to delivery.|Participants will be followed from time of diagnosis of vasa previa until the baby is born, an expected time frame of 9 months||||Participants|||Count of Participants
2617707|NCT01976988|Secondary|Number of Participants With VTE Within 30-day After Surgery|any VTE occuring within 30-days after surgery - clinical or asymptomatic - detected by venous duplex ultrasound, vq scan or ct pulmonary angiogram.|30 day postop period||||participants|||Number
2617708|NCT01976988|Secondary|Hospital Stay|Length of postoperative hospital stay|30 day postop period||||days||Inter-Quartile Range|Median
2617709|NCT01976988|Secondary|Number of Participants With Surgical Complications|Major or minor medical and surgical complications|30 day postop period||||participants|||Number
2617710|NCT01976988|Secondary|Number of Participants With Postoperative Thrombocytopenia|Thrombocytopenia defined as >50% or greater drop in platelet count|30 day postop period||||participants|||Number
2617711|NCT01976988|Secondary|Number of Participants With Bleeding Complications|"Major bleeding defined as any intracranial or intraocular hemorrhage or bleeding from any site associated with >2g/dL drop in hemoglobin or transfusion of >2 unit packed RBCs (including operative site bleeding, unexpected upper or lower gastrointestinal hemorrhage, or retroperitoneal hemorrhage) or any hemorrhage needing surgical intervention/reoperation or leading to death.~Minor bleeding defined as wound hematoma, ecchymosis >10 cm, epistaxis of more than 2 minute duration, macroscopic hematuria, unexpected upper or lower GI hemorrhage associated with <2g/dL drop in hemoglobin or <2 unit packed RBC transfusion"|30 day postop period||||participants|||Number
2617712|NCT01976988|Primary|Number of Participants With Postoperative VTE Within 48 Hours After Surgery|Number of participants with postoperative VTE (deep venous thrombosis (DVT) or pulmonary embolism (PE) as demonstrated by duplex sonography or high probability on ventilation-perfusion scan or CT chest angiography within 48 hour postop period|48 hour postop period||||participants|||Number
2617713|NCT01976975|Secondary|Symptom Severity at 6 Month Follow-up|"Beck Depression Inventory (BDI-II). Severity of depressive symptoms, from 0 (no symptoms) to 63 (severely depressed)~Young Mania Rating Scale (YMRS). Severity of manic symptoms, from 0 (not manic) to 60 (severely manic)~Temporal Experience of Pleasure Scale (TEPS). The TEPS is an 18-item questionnaire. Ten items make up the TEPS-Anticipatory Pleasure scale with a range from 10 (not motivated) to 60 (highly motivated).~The other eight TEPS items make up the TEPS-Consummatory Pleasure scale; range from 8 (not responsive) to 48 (highly responsive)~Mood and Anxiety Symptom Questionnaire - Anhedonic Depression (MASQ-AD). The MASQ is a 62-item self-report on the severity of anxiety and depressive symptoms. The AD subscale is a 22-item measure of severity of anhedonic symptoms. Range: 22 -110 (higher scores mean greater severity)~Barrett Impulsiveness Scale 11 (BIS-11): a 30-item assessment of Trait Impulsivity. Range: 30-120 (higher scores mean more impulsiveness)"|6 months|Population includes patients and controls who completed the 6-month follow up session|||units on a scale||Full Range|Mean
2617714|NCT01976975|Primary|Mean Accuracy on Gain Trials During an Instrumental Learning Task|The instrumental learning task requires participants to choose between two abstract symbols. Each symbol in the pair is associated with an 80% or 20% probability of a given outcome (gain: win $1 or $0; loss: lose $1 or $0; neutral: view a gray square or see the word 'nothing'). The task consists of three blocks. Behavioral performance focuses on the number of times the participant chose the symbol that was associated more frequently associated with the more desirable outcome. A participant scores 1 if they choose correctly, and 0 if they choose in correctly, and correct choices across all three blocks are added and converted to a percentage relative to the total number of trials in that condition (i.e., gain, loss, or neutral). This study focused on percent of accuracy responses in the gain condition.|Administered in session 3 during 1.5 hour MR scan|All participants who had readable Pessiglione task data|||Percent of accurate responses||Full Range|Mean
2617857|NCT01975701|Primary|Progression Free Survival|To assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes that harbor FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3 based on PFS6 (PFS rate at 6 months as defined by RANO criteria as assessed by the investigator)|6 months|full analysis set, patients censored|||months||95% Confidence Interval|Median
2617715|NCT01976975|Primary|Change in Response Bias|"The Probabilistic Reward Task (PRT) is a behavioral task that measures an individual's ability to learn to choose a more rewarding outcome versus a less rewarding one (Response Bias). The response bias score is a ratio of the number of times a participant correctly chooses the high reward stimulus (the rich stimulus) versus the low reward stimulus (the lean stimulus). Response bias scores range between -1 and +1. A higher Response Bias score indicates a stronger bias toward the rich stimulus, and a negative Response Bias indicates a stronger bias toward the lean stimulus. The Change-in-Response-Bias is calculated by subtracting Response Bias in block 1 (trials 0-100) of the task from Response Bias in block 3 (trials 201-300) of the task. This metric represents the degree to which an individual is able to update behavior as a function of the asymmetrical reinforcement schedule."|Administered during the first session.|Population includes patients and healthy controls who completed the PRT during the first session.|||log-transformed ratio of scores||Full Range|Mean
2617716|NCT01976871|Secondary|The Clinician Global Impression of Change Scale|The Clinician Global Impression of Change scale (CGIC) will be used to assess patient satisfaction with treatment.|Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)||||participants|||Number
2617717|NCT01976871|Secondary|The Patient Global Impression of Change Scale|"The Patient Global Impression of Change scale (PGIC) will be used to assess patient satisfaction with treatment.~The PGIC assesses subjective changes in symptoms during clinical trials. This single-item scale asks participants to rate their symptoms as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. The measure provides a responsive and easily interpretable assessment of participants' evaluations of the importance of their improvement or worsening."|Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)||||participants|||Number
2617718|NCT01976871|Secondary|Preference of Medication Scale (POM)|"The POM will be used to assess patient satisfaction with treatment.~The POM scale is designed to summarize subjects' preference for the study medication compared to prior therapy. It asks a single question: How does this current medicine compare to the previous RLS medicine(s) you were taking? The response set is as follows: (1) Much Better, I prefer this medication (indicating preference for rotigotine); (2) Slightly Better; (3) About the Same; (4) Slightly Worse; (5) Much Worse, I much prefer my previous medication (indicating preference for oral dopamine agonist)."|Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)||||participants|||Number
2617719|NCT01976871|Secondary|RLS-6 Scale|"The RLS-6 scale will be used to determine the overall efficacy of RLS symptom control on rotigotine, calculated as a mean score for each scale during the final treatment week vs baseline.~The RLS-6 scale are 11-point (0=not present to 10=very severe) metrics for measuring RLS severity. Four questions delineate a severity profile of RLS during different night and daytime periods: at bedtime, during the night, during the day at rest, during daily activities. The final two questions assess satisfaction with sleep and severity of sleepiness during the day. The RLS-6 scales have been validated on a day-to-day basis, with relatively low placebo effect compared to other RLS rating scales.~Minimum score 0, maximum score 60. A decrease in the RLS-6 score indicates a better outcome. The RLS-6 scale was completed each day of the study and averaged for the baseline week (approximately days 1-7 of the study) and the final week (approximately days 21-28 of the maintenance period)."|Average of Baseline titration week (approximately days 1-7 of the study) vs. Average of Final Treatment week (integrating data from days 28-35 after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)||||units on a scale||Standard Deviation|Mean
2617720|NCT01976871|Secondary|International Restless Legs Scale (IRLS)|"The IRLS will be used to determine the overall efficacy of RLS symptom control on rotigotine.~The IRLS is a well-validated instrument for measuring RLS severity during the past week. It includes 10 questions encompassing intensity and frequency of symptoms, associated sleep problems, and the impact of symptoms on the patients' mood and daily functioning. This scale has been shown to have high internal consistency, inter-examiner reliability, test-retest reliability, and convergent validity.~Minimum score 0, maximum score 40. A decrease in the IRLS score indicates a better outcome."|Study Visit 1 (Day 1) and Study Visit 3 (approximately 35 days after initiating the switch from the oral dopamine agonist to the transdermal rotigotine)||||units on a scale||Standard Deviation|Mean
2617721|NCT01976871|Primary|Proportion of Patients Completing the Switch and Their Adverse Events|"The primary endpoint will be the safety and tolerability of switching from an oral dopamine agonist to rotigotine.~The CGIC scales were developed to assess treatment outcomes in pharmacological studies. The scales are meant completed by the clinician in person after assessment of the subject. They include 4 global scales describing the severity of illness, change in severity from baseline, therapeutic efficacy, and tolerability of treatment.~Clinical Global Impression - Improvement scale (CGI-I) rated as: 1, very much improved since the baseline week; 2, much improved; 3, minimally improved; 4, no change from baseline; 5, minimally worse; 6, much worse; or 7, very much worse since the baseline week. The CGI-I was performed at baseline and at Week 5 to see which participants rated as much or very much improved.~Adverse Events are reported in the Adverse Events module."|Participants will be monitored for the duration of the study, approximately 6-10 weeks depending upon scheduling of visits||||participants|||Number
2617722|NCT01976845|Secondary|Produces Amnesia(Memory Recall)|"Ability to recall (memory of):~•recall of 2 pictures"|one day|Subjects who recall the picture|||participants|||Number
2617723|NCT01976845|Secondary|Scores on the Verbal Rating Scale For Sleepiness (Sedation)|Using the verbal rating scale (VRS) for anxiety (0= none to 10 = extremely sleepiness)|one day||||Scores on a Scale (0-10)||Standard Deviation|Mean
2617724|NCT01976845|Primary|Scores on the Verbal Rating Scale For Anxiety|Using the verbal rating scale (VRS) for anxiety (0= none to 10 = extremely nervous)|one day||||Scores on a Scale (0-10)||Standard Deviation|Mean
2617725|NCT01976819|Primary|Device Preference Rating.|"Patients were asked to rate the devices on a scale from 0-10, where 10 indicates the best score and 0 the worst score. The overall mean satisfaction with the speaking valve was rated."|Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)||||units on a scale||Standard Deviation|Mean
2617726|NCT01976819|Primary|Hours of HME Use Per Day.|The mean number of hours of TW use per 24 hours was calculated.|Weeks 1 and 2 (Old device, data averaged) and Week 3 (Updated device)||||hours per day||Standard Deviation|Mean
2617727|NCT01976819|Primary|Evaluate Patient Experiences Associated With Exposure to the Speaking Valve With a Heat- and Moisture Exchanger (TW) for Tracheotomized Patients Based on Results From Questionnaires.|"Patients were asked to use either the old TW15 and the TW22 HME device for a week, data combined for the two devices (the device used was recorded). After each week, patients completed a device specific questionnaire (Borg Scale).~After the re-design (ie Updated speaking valve), patients were asked to use the new Speaking Valve for a week and then to complete relevant sections of the same questionnaire. Both at baseline and in the follow-up, patients were asked about their breathing using a Borg scale at a particular moment. This scale has a range from 0-6 where a score close to 0 indicates less breathing problems."|3 weeks including Baseline, week 1, 2 (old device) and week 3 (updated device).||||units on a scale||Standard Deviation|Mean
2617728|NCT01976806|Other Pre-specified|Change in Red Blood Cell Membrane Docosahexaenoic Acid|Red blood cell phospholipid fatty acids were measured at baseline and 3-month follow up as a measure of adherence.|Baseline and 3 months||||% of total RBC FA||Standard Error|Mean
2617729|NCT01976806|Secondary|Urine N-Terminal Telopeptides|Urine N-Terminal Telopeptides are a measure of systemic bone turnover.|Baseline and 3 months||||nM BCE||Standard Error|Mean
2617730|NCT01976806|Secondary|Serum Soluble Vascular Cell Adhesion Molecule|Serum soluble vascular cell adhesion molecule (VCAM) is a measure of systemic inflammation.|Baseline and 3 months||||ng/mL||Standard Error|Mean
2617731|NCT01976806|Secondary|Serum High-sensitivity Interleukin-6|Serum high-sensitivity interleukin-6 is a measure of systemic inflammation.|Baseline and 3 months||||pg/mL||Standard Error|Mean
2617732|NCT01976806|Secondary|Serum High-sensitivity C-reactive Protein|Serum high-sensitivity C-reactive protein is a measure of systemic inflammation.|Baseline and 3 months||||mg/L||Standard Error|Mean
2617733|NCT01976806|Secondary|Gingival Crevicular Fluid Interleukin-1 Beta|Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-1 beta, which is a measure of local gingival inflammation.|Baseline and 3 months|Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected.|||pg/mL||Standard Error|Mean
2617734|NCT01976806|Secondary|Gingival Crevicular Fluid Interleukin-6|Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-6, which is a measure of local gingival inflammation.|Baseline and 3 months|Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected.|||pg/mL||Standard Error|Mean
2617735|NCT01976806|Secondary|Gingival Crevicular Fluid High Sensitivity C-reactive Protein|Gingival crevicular fluid (GCF) is the fluid bathing the teeth under the gum line. GCF samples were analyzed for high sensitivity C-reactive protein as a measure of local gingival inflammation.|Baseline and 3 months|Performed in all participants with baseline and 3 month visits in whom usable GCF samples could be collected.|||ng/mL||Standard Error|Mean
2617736|NCT01976806|Secondary|Sites With Bleeding on Probing (Yes/no)|Bleeding On Probing (BOP) is a measure of gingival inflammation and tissue destruction, which describes whether or not bleeding at the dental pocket occurred following probing.|3 months|Results presented at 3 months; 3-months results also compared to baseline BOP using logistic regression as described in manuscript.|||Sites|Sites||Count of Units
2617737|NCT01976806|Secondary|Change in Plaque Index (0-3)|"Plaque Index (PI) is a measure of gingival inflammation as induced by bacterial plaque deposition at and under the gum line.~Score Criteria:~0: No plaque~A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which can not be seen with the naked eye. But only by using disclosing solution or by using probe.~Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye.~Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin."|Baseline and 3 months||||Plaque index units||Standard Error|Mean
2617738|NCT01976806|Secondary|Change in Gingival Index (0-3)|"Gingival Index (GI) is a measure of gingival inflammation, which is assigned a score (0-3).~Score Criteria:~0: No inflammation.~Mild inflammation, slight change in color, slight edema, no bleeding on probing.~Moderate inflammation, moderate glazing, redness, bleeding on probing.~Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding."|Baseline and 3 months||||GI units||Standard Error|Mean
2617739|NCT01976806|Primary|Change in Pocket Depth (mm)|Pocket probing depth (PD) is the depth a dental probe can be inserted into a gingival pocket at a particular site (6 sites per tooth) measured in millimeters among teeth with PD greater than or equal to 5 mm (N=533 dental sites total).|Baseline and 3 months||||mm||Standard Error|Mean
2617740|NCT01976741|Secondary|Tlast,md (Time of Last Plasma Concentration Above LLOQ After Multiple-dose Administration) of BAY1163877 on Cycle 1, Day 15|Tlast,md (time of last plasma concentration above LLOQ after multiple-dose administration) of BAY1163877. Median and full range were reported.|pre-dose (before morning dose), and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose|All participants with valid PK data on Cycle 1, Day 15. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants received 800 mg BID in either escalation or expansion phase were combined as there was no significant difference of PK between tumor groups observed.|||hours||Full Range|Median
2617741|NCT01976741|Secondary|Tmax,md (Time to Reach Maximum Drug Concentration in Plasma After Multiple-dose Administration) of BAY1163877 on Cycle 1, Day 15|Tmax,md (time to reach maximum drug concentration in plasma after multiple-dose administration) of BAY1163877. Median and full range were reported.|pre-dose (before morning dose), and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose|All participants with valid PK data on Cycle 1, Day 15. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants received 800 mg BID in either escalation or expansion phase were combined as there was no significant difference of PK between tumor groups observed.|||hours||Full Range|Median
2617742|NCT01976741|Secondary|T1/2 (Half-life Associated With the Terminal Slope) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3 and Cycle 1, Day 1|T1/2 (half-life associated with the terminal slope) of BAY1163877 after single dose administration on Cycle 1, Day -3 and Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hour(s) post-dose|All participants with valid PK data on Cycle 1, Day -3 and on Cycle 1, Day 1. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants received 800 mg BID in either escalation or expansion phase were combined as there was no significant difference of PK between tumor groups observed.|||hours||Geometric Coefficient of Variation|Geometric Mean
2617743|NCT01976741|Secondary|Tlast (Time of Last Plasma Concentration Above LLOQ) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3 and Cycle 1, Day 1|Tlast (time of last plasma concentration above LLOQ) of BAY1163877 after single dose administration on Cycle 1, Day -3 and Cycle 1, Day 1. Median and full range were reported.|pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hour(s) post-dose|All participants with valid PK data on Cycle 1, Day -3 and on Cycle 1, Day 1. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants received 800 mg BID in either escalation or expansion phase were combined as there was no significant difference of PK between tumor groups observed.|||hours||Full Range|Median
2617744|NCT01976741|Secondary|Tmax (Time to Reach Maximum Drug Concentration in Plasma) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3 and Cycle 1, Day 1|Tmax (time to reach maximum drug concentration in plasma) of BAY1163877 after single dose administration on Cycle 1, Day -3 and Cycle 1, Day 1. Median and full range were reported.|pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hour(s) post-dose|All participants with valid PK data on Cycle 1, Day -3 and on Cycle 1, Day 1. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants received 800 mg BID in either escalation or expansion phase were combined as there was no significant difference of PK between tumor groups observed.|||hours||Full Range|Median
2617745|NCT01976741|Secondary|Evaluation of Relative Bioavailability of the Tablet Formulation in Comparison to the Solution Formulation of BAY1163877|In order to evaluate the relative bioavailability of the tablet formulation, tablet Cmax/D, AUC(0-tlast)/D, and AUC/D on Cycle 1, Day -3 was compared to solution Cmax/D, AUC(0-tlast)/D, AUC/D on Cycle 1, Day 1 for all analytes. The logarithms of the PK parameters was analyzed using analysis of variance (ANOVA) including subject and formulation effects. Based on these analyses, point estimates (LS-means) and exploratory 90% confidence intervals for the ratios (tablet/solution) of Cmax/D, AUC(0- tlast)/D, and AUC/D was calculated by re-transformation of the logarithmic data using the intra-individual standard deviation of the ANOVA.|On Cycle 1, Day -3 and Cycle 1, Day 1|Participants received both tablet and solution formulation.|||ratio||90% Confidence Interval|Geometric Least Squares Mean
2617746|NCT01976741|Secondary|Evaluation of Pharmacodynamic Parameters (PD) - Change of QT Intervals From Baseline up to Cycle 1, Day 15||From baseline up to Cycle 1, Day 15|Safety Analysis Set (SAF): All participants who received at least one dose of the study medication, and valid data for this outcome measure.|||msec||Standard Deviation|Mean
2617747|NCT01976741|Secondary|Evaluation of Pharmacodynamic Parameters (PD) - Change of Blood Pressure (BP) From Baseline to End of Study||From baseline up to 2 years|Participants received at least one dose of Rogaratinib and have valid data for this outcome measure. Participants were grouped as described in the SAP to allow a comparison of all dose escalation patients (all dose levels pooled together), dose expansion patients (four groups) and total number of patients (overview summaries) in the same table.|||mmHg||Standard Deviation|Mean
2617748|NCT01976741|Secondary|Evaluation of Pharmacodynamic Parameters (PD) - Change of Heart Rate (HR) From Baseline to End of Study||From baseline up to 2 years|Participants received at least one dose of Rogaratinib and have valid data for this outcome measure. Participants were grouped as described in the SAP to allow a comparison of all dose escalation patients (all dose levels pooled together), dose expansion patients (four groups) and total number of patients (overview summaries) in the same table.|||beats per minute||Standard Deviation|Mean
2617749|NCT01976741|Secondary|Evaluation of Biomarker Status - Number of Participants With Any Significant Change in FGF23 (Fibroblast Growth Factor 23) From Baseline to End of Study||From baseline up to 2 years|The study team grouped the patients as described in the SAP in order to allow a comparison of all dose escalation patients (all dose levels pooled together), dose expansion patients (four groups) and total number of patients (overview summaries) in the same table.|||Participants|||Count of Participants
2617750|NCT01976741|Secondary|Duration of Treatment (DOT)||Up to 2 years|Participants received at least one dose of Rogaratinib and have post-baseline efficacy data available. Participants were grouped as described in the SAP to allow a comparison of all dose escalation patients (all dose levels pooled together), dose expansion patients (four groups) and total number of patients (overview summaries) in the same table.|||Days||95% Confidence Interval|Median
2617751|NCT01976741|Secondary|Duration of Response (DOR)|DOR (for partial and complete response (PR/CR)) was defined as the time (days) from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). DOR was calculated for responders only, i.e. participants with complete or partial response. Therefore, the dose escalation group is not displayed.|Up to 2 years|Participants with a documented objective response of PR or CR.|||Days||95% Confidence Interval|Median
2617752|NCT01976741|Secondary|Time to Progression (TTP)|TTP was defined as the time from start of study treatment until first observed disease progression (radiological or clinical). Progression is defined using RECIST v1.0, as at least a 20% increase in the sum of diameters of the target lesions, taking as a references the smallest sum on study.|Up to 2 years|Participants received at least one dose of Rogaratinib and have post-baseline efficacy data available. Participants were grouped as described in the SAP to allow a comparison of all dose escalation patients (all dose levels pooled together), dose expansion patients (four groups) and total number of patients (overview summaries) in the same table.|||Days||95% Confidence Interval|Median
2617753|NCT01976741|Secondary|Progression-free Survival (PFS)|PFS was defined as the time (days) from the date of the first dose of study drug to the date of the first observed disease progression (radiological or clinical) or death due to any cause, if death occurred before progression was documented. PFS for participants without tumor progression at the time of analysis was censored at their last date of tumor evaluation.|Up to 2 years|Participants received at least one dose of Rogaratinib and have post-baseline efficacy data available. Participants were grouped as described in the SAP to allow a comparison of all dose escalation patients (all dose levels pooled together), dose expansion patients (four groups) and total number of patients (overview summaries) in the same table.|||Days||95% Confidence Interval|Median
2617858|NCT01975675|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug|||percentage of participants|||Number
2619519|NCT01963091|Primary|Salivary Cortisol Levels|salivary cortisol|0 minutes post 15 minute stress task||||mg/dl||Standard Deviation|Mean
2617754|NCT01976741|Secondary|Response Rate as Defined by RECIST Version 1.1 Reported as Number of Participants With Different Response Type|Response as defined by RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1: complete response (CR: disappearance of all target lesions), partial response (PR: at least a 30% decrease in the sum of diameters of target lesions taking as the reference the baseline sum of diameters), stable disease (SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference, the smallest sum of diameters while in the trial), progressive disease (PD: at least a 20% increase in the sum of diameters of the target lesions, taking as a references the smallest sum on study).|Up to 2 years|Participants received at least one dose of Rogaratinib and have post-baseline efficacy data available. Participants were grouped as described in the SAP to allow a comparison of all dose escalation patients (all dose levels pooled together), dose expansion patients (four groups) and total number of patients (overview summaries) in the same table.|||Participants|||Count of Participants
2617755|NCT01976741|Primary|AE,ur(12-24) (Amount of Drug Excreted Via Urine During the Collection Interval 12 - 24 Hours Post Administration) of BAY1163877|AE,ur(12-24) (amount of drug excreted via urine during the collection interval 12 - 24 hours post administration) of BAY1163877.|On Cycle1, Day 1|All participants from the 800 mg BID escalation as well as the 800 mg BID expansion cohorts were combined into a pooled 800 mg BID group for PK statistics, as there was no significant difference of PK between tumor groups observed.|||mg||Standard Deviation|Mean
2617756|NCT01976741|Primary|AE,ur(0-24) (Amount of Drug Excreted Via Urine During the Collection Interval 0 - 24 Hours Post Administration) of BAY1163877|AE,ur(0-24) (amount of drug excreted via urine during the collection interval 0 - 24 hours post administration) of BAY1163877.|On Cycle1, Day 1|All participants from the 800 mg BID escalation as well as the 800 mg BID expansion cohorts were combined into a pooled 800 mg BID group for PK statistics, as there was no significant difference of PK between tumor groups observed.|||mg||Standard Deviation|Mean
2617757|NCT01976741|Primary|AE,ur(0-12) (Amount of Drug Excreted Via Urine During the Collection Interval 0 - 12 Hours Post Administration) of BAY1163877|AE,ur(0-12) (amount of drug excreted via urine during the collection interval 0 - 12 hours post administration) of BAY1163877.|On Cycle1, Day 1|All participants from the 800 mg BID escalation as well as the 800 mg BID expansion cohorts were combined into a pooled 800 mg BID group for PK statistics, as there was no significant difference of PK between tumor groups observed.|||mg||Standard Deviation|Mean
2617758|NCT01976741|Primary|AUC(0-tlast)/Dmd (AUC(0-tlast) Divided by Dose After Multiple-dose Administration) of BAY1163877 on Cycle 1, Day 15|AUC(0-tlast)/Dmd (AUC(0-tlast) divided by dose after multiple-dose administration) of BAY1163877. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose (before morning dose), and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose|All participants with valid PK data on Cycle 1, Day 15. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants received 800 mg BID in either escalation or expansion phase were combined as there was no significant difference of PK between tumor groups observed.|||h/L||Geometric Coefficient of Variation|Geometric Mean
2617759|NCT01976741|Primary|AUC(0-tlast)md (AUC(0-tlast) After Multiple Dose Administration) of BAY1163877 on Cycle 1, Day 15|AUC(0-tlast)md (AUC(0-tlast) after multiple dose administration) of BAY1163877. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose (before morning dose), and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose|All participants with valid PK data on Cycle 1, Day 15. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants received 800 mg BID in either escalation or expansion phase were combined as there was no significant difference of PK between tumor groups observed.|||µg*h/L||Geometric Coefficient of Variation|Geometric Mean
2617760|NCT01976741|Primary|AUC(0-12)/Dmd (AUC(0-12) Divided by Dose After Multiple-dose Administration) of BAY1163877 on Cycle 1, Day 15|AUC(0-12)/Dmd (AUC(0-12) divided by dose after multiple-dose administration) of BAY1163877. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose (before morning dose), and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose|All participants with valid PK data on Cycle 1, Day 15. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants received 800 mg BID in either escalation or expansion phase were combined as there was no significant difference of PK between tumor groups observed.|||h/L||Geometric Coefficient of Variation|Geometric Mean
2617761|NCT01976741|Primary|AUC(0-12)md (AUC(0-12) After Multiple-dose Administration) of BAY1163877 on Cycle 1, Day 15|AUC(0-12)md (AUC(0-12) after multiple-dose administration) of BAY1163877. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose (before morning dose), and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose|All participants with valid PK data on Cycle 1, Day 15. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants received 800 mg BID in either escalation or expansion phase were combined as there was no significant difference of PK between tumor groups observed.|||µg*h/L||Geometric Coefficient of Variation|Geometric Mean
2617762|NCT01976741|Primary|Cmax/Dmd (Cmax Divided by Dose After Multiple-dose Administration) of BAY1163877 on Cycle 1, Day 15|Cmax/Dmd (Cmax divided by dose after multiple-dose administration) of BAY1163877. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose (before morning dose), and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose|All participants with valid PK data on Cycle 1, Day 15. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants received 800 mg BID in either escalation or expansion phase were combined as there was no significant difference of PK between tumor groups observed.|||/L||Geometric Coefficient of Variation|Geometric Mean
2617763|NCT01976741|Primary|Cmax,md (Cmax After Multiple-dose Administration) of BAY1163877 on Cycle 1, Day 15|Cmax,md (Cmax after multiple-dose administration) of BAY1163877. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose (before morning dose), and 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post-dose|All participants with valid PK data on Cycle 1, Day 15. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants received 800 mg BID in either escalation or expansion phase were combined as there was no significant difference of PK between tumor groups observed.|||µg/L||Geometric Coefficient of Variation|Geometric Mean
2623139|NCT01932970|Secondary|Percent Change From Baseline in Parathyroid Hormone During the Treatment Period||Baseline and weeks 2, 3 and 4|Full analysis set with available data at each time point|||percent change||Standard Error|Mean
2617764|NCT01976741|Primary|AUC/D (AUC Divided by Dose) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1|AUC divided by dose (AUC/D) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2)|All participants with valid PK data on Cycle 1, Day 1. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants received 800 mg BID in either escalation or expansion phase were combined as there was no significant difference of PK between tumor groups observed.|||h/L||Geometric Coefficient of Variation|Geometric Mean
2617765|NCT01976741|Primary|AUC/D (AUC Divided by Dose) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3|AUC divided by dose (AUC/D) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1)|All participants with valid PK data on Cycle 1, Day -3. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect.|||h/L||Geometric Coefficient of Variation|Geometric Mean
2617766|NCT01976741|Primary|AUC(0-tlast)/D (Area Under the Plasma Concentration vs Time Curve From Time Zero to the Last Data Point > LLOQ Divided by Dose) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1|Area under the plasma concentration vs time curve from time zero to the last data point > LLOQ divided by dose (AUC(0-tlast)/D) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2)|All participants with valid PK data on Cycle 1, Day 1. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants received 800 mg BID in either escalation or expansion phase were combined as there was no significant difference of PK between tumor groups observed.|||h/L||Geometric Coefficient of Variation|Geometric Mean
2617767|NCT01976741|Primary|AUC(0-tlast)/D (Area Under the Plasma Concentration vs Time Curve From Time Zero to the Last Data Point > LLOQ Divided by Dose) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3|Area under the plasma concentration vs time curve from time zero to the last data point > LLOQ divided by dose (AUC(0-tlast)/D) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1)|All participants with valid PK data on Cycle 1, Day -3. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect.|||h/L||Geometric Coefficient of Variation|Geometric Mean
2617768|NCT01976741|Primary|AUC(0-12)/D (Area Under the Plasma Concentration vs Time Curve From Time Zero to 12 Hours Divided by Dose) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1|Area under the plasma concentration vs time curve from time zero to 12 hours divided by dose (AUC(0-12)/D) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2)|All participants with valid PK data on Cycle 1, Day 1. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants received 800 mg BID in either escalation or expansion phase were combined as there was no significant difference of PK between tumor groups observed.|||h/L||Geometric Coefficient of Variation|Geometric Mean
2617769|NCT01976741|Primary|AUC(0-12)/D (Area Under the Plasma Concentration vs Time Curve From Time Zero to 12 Hours Divided by Dose) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3|Area under the plasma concentration vs time curve from time zero to 12 hours divided by dose (AUC(0-12)/D) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1)|All participants with valid PK data on Cycle 1, Day -3. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect.|||h/L||Geometric Coefficient of Variation|Geometric Mean
2617770|NCT01976741|Primary|Cmax/D (Maximum Drug Concentration in Plasma Divided by Dose) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1|Maximum drug concentration in plasma divided by dose (Cmax/D) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2)|All participants with valid PK data on Cycle 1, Day 1. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants received 800 mg BID in either escalation or expansion phase were combined as there was no significant difference of PK between tumor groups observed.|||/L||Geometric Coefficient of Variation|Geometric Mean
2617771|NCT01976741|Primary|Cmax/D (Maximum Drug Concentration in Plasma Divided by Dose) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3|Maximum drug concentration in plasma divided by dose (Cmax/D) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1)|All participants with valid PK data on Cycle 1, Day -3. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect.|||/L||Geometric Coefficient of Variation|Geometric Mean
2617772|NCT01976741|Primary|AUC (Area Under the Plasma Concentration vs Time Curve From Zero to Infinity) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1|Area under the plasma concentration vs time curve from zero to infinity (AUC) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2)|All participants with valid PK data on Cycle 1, Day 1. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants received 800 mg BID in either escalation or expansion phase were combined as there was no significant difference of PK between tumor groups observed.|||µg*h/L||Geometric Coefficient of Variation|Geometric Mean
2618151|NCT01973231|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline|Change from baseline in FPG after 26 weeks of treatment.|Week 0, week 26|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing FPG post baseline data, 194 and 189 subjects in liraglutide and lixisenatide treatment group, respectively were included in the FPG analysis.|||mmol/L||Standard Deviation|Mean
2617773|NCT01976741|Primary|AUC (Area Under the Plasma Concentration vs Time Curve From Zero to Infinity) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3|Area under the plasma concentration vs time curve from zero to infinity (AUC) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1)|All participants with valid PK data on Cycle 1, Day -3. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect.|||µg*h/L||Geometric Coefficient of Variation|Geometric Mean
2617774|NCT01976741|Primary|AUC(0-tlast) (Area Under the Plasma Concentration vs Time Curve From Time Zero to the Last Data Point > LLOQ [Lower Limit of Quantification]) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1|Area under the plasma concentration vs time curve from time zero to the last data point > LLOQ [lower limit of quantification] (AUC(0-tlast)) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2)|All participants with valid PK data on Cycle 1, Day 1. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants received 800 mg BID in either escalation or expansion phase were combined as there was no significant difference of PK between tumor groups observed.|||µg*h/L||Geometric Coefficient of Variation|Geometric Mean
2617775|NCT01976741|Primary|AUC(0-tlast) (Area Under the Plasma Concentration vs Time Curve From Time Zero to the Last Data Point > LLOQ [Lower Limit of Quantification]) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3|Area under the plasma concentration vs time curve from time zero to the last data point > LLOQ [lower limit of quantification] (AUC(0-tlast)) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1)|All participants with valid PK data on Cycle 1, Day -3. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect.|||µg*h/L||Geometric Coefficient of Variation|Geometric Mean
2617776|NCT01976741|Primary|AUC(0-12) (Area Under the Plasma Concentration vs Time Curve From Time Zero to 12 Hours) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1|Area under the plasma concentration vs time curve from time zero to 12 hours (AUC(0-12)) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2)|All participants with valid PK data on Cycle 1, Day 1. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants received 800 mg BID in either escalation or expansion phase were combined as there was no significant difference of PK between tumor groups observed.|||µg*h/L||Geometric Coefficient of Variation|Geometric Mean
2617777|NCT01976741|Primary|AUC(0-12) (Area Under the Plasma Concentration vs Time Curve From Time Zero to 12 Hours) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3|Area under the plasma concentration vs time curve from time zero to 12 hours (AUC(0-12)) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1)|All participants with valid PK data on Cycle 1, Day -3. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect.|||µg*h/L||Geometric Coefficient of Variation|Geometric Mean
2617778|NCT01976741|Primary|Cmax (Maximum Drug Concentration in Plasma) of BAY1163877 After Single Dose Administration on Cycle 1, Day 1|Maximum drug concentration in plasma (Cmax) of BAY1163877 after single dose administration on Cycle 1, Day 1. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day 1) and 48 hour(s) post-dose (Day 2)|All participants with valid PK data on Cycle 1, Day 1. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect, and participants received 800 mg BID in either escalation or expansion phase were combined as there was no significant difference of PK between tumor groups observed.|||µg/L||Geometric Coefficient of Variation|Geometric Mean
2617779|NCT01976741|Primary|Cmax (Maximum Drug Concentration in Plasma) of BAY1163877 After Single Dose Administration on Cycle 1, Day -3|Maximum drug concentration in plasma (Cmax) of BAY1163877 after single dose administration on Cycle 1, Day -3. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.|pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (Day -2) and 48 hour(s) post-dose (Day -1)|All participants with valid pharmacokinetic (PK) data on Cycle 1, Day -3. Some of the participants from the expansion cohorts were included in Rogaratinib expansion food effect.|||µg/L||Geometric Coefficient of Variation|Geometric Mean
2617780|NCT01976741|Primary|Number of DLTs During Cycle 1|DLT was defined as any of the pre-defined adverse events occurring during Cycle 1 of a dose level and regarded by the investigators and/or sponsor to be related to the investigational drug.|Up to 21 days|All participants in the dose escalation phase.|||DLTs|||Number
2617781|NCT01976741|Primary|Maximum Tolerated Dose (MTD), Defined as Maximum Dose at Which the Incidence of Drug Limiting Toxicities (DLTs) During Cycle 1 is Below 20%|The MTD was defined as maximum dose at which the incidence of Drug Limiting Toxicities (DLTs) during Cycle 1 is below 20%. DLT was defined as any of the pre-defined adverse events occurring during Cycle 1 of a dose level and regarded by the investigators and/or sponsor to be related to the investigational drug. BID=twice daily.|Up to 21 days|All participants in the dose escalation phase.|||mg BID|||Number
2617782|NCT01976663|Secondary|Mean Change From Baseline in Overall Nasolabial Folds FACE-Q Score|Subjects evaluate nasolabial folds on the 5-item Nasolabial Folds module of the FACE-Q questionnaire. Responses to the 5 items are combined to create a scale score that ranged from 0 to 100, where 0 indicates that the subject is extremely bothered and 100 indicates that the subject is not all bothered by the appearance of the nasolabial fold. Change from baseline is defined as the score at Month 12 minus the baseline score. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, Month 12|modified intent-to-treat (mITT): all randomized and treated subjects with data at this time point|||Scores on a Scale||Standard Deviation|Mean
2618168|NCT01973062|Secondary|Progression Free Survival|The number of patients without an unequivocal increase in tumor size or the appearance of new lesions by MRI|Up to 2 years|Only one patient registered. No patient data analyzed||||||
2617783|NCT01976663|Secondary|Percentage of Nasolabial Folds With ≥1-Point Improvement|Nasolabial fold severity is evaluated by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). The percentage of nasolabial folds with ≥1-point improvement from baseline (i.e., decrease in severity) are reported.|Baseline, Month 12|modified intent-to-treat (mITT): all randomized and treated subjects with data for this outcome measure|||Percentage of Nasolabial Folds||95% Confidence Interval|Number
2617784|NCT01976663|Primary|Percentage of Nasolabial Folds With ≥1-Point Improvement|Nasolabial fold severity is evaluated by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). The percentage of nasolabial folds with ≥1-point improvement from baseline (i.e., decrease in severity) are reported.|Baseline, Month 6|modified intent-to-treat (mITT): all randomized and treated subjects with data for this outcome measure|||Percentage of Nasolabial Folds||95% Confidence Interval|Number
2617785|NCT01976663|Primary|Mean Change From Baseline in Nasolabial Fold Severity Using the 5-Point Nasolabial Fold Severity Scale (NLFSS)|Nasolabial fold severity is assessed by the Evaluating Investigator on the 5-point Nasolabial Fold Severity Scale (ranging from 0=None [no wrinkle] to 4=Extreme [very deep wrinkle, redundant fold]). Mean change from baseline in NFLSS is defined as score at baseline minus score at Month 6. A negative number change from baseline indicated improvement and a positive number change from baseline indicated worsening.|Baseline, Month 6|modified intent-to-treat (mITT): all randomized and treated subjects|||Scores on a Scale||Standard Deviation|Mean
2617786|NCT01976650|Secondary|Percentage of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved and was considered 'effective'. The percentage of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.|4 Years|Efficacy Population: all patients who were treated per protocol who had data available for analysis|||Percentage of Participants|||Number
2617787|NCT01976650|Primary|Number of Patients With Adverse Events or Adverse Drug Reactions|An Adverse Event is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction is a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.|4 Years|Safety Population: all patients who were treated per protocol and completed a survey|||Patients|||Number
2617788|NCT01976624|Secondary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicated an improvement. The median total treatment duration for participants was 63.0 days.|Baseline, Week 4|Efficacy population included all participants who were treated for on-label indications with data available for analysis.|||mmHg||Standard Deviation|Mean
2617789|NCT01976624|Primary|Number of Participants With Adverse Events and Adverse Drug Reactions|An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.|Up to 51 months|Safety population included all participants treated for on-label indications.|||participants|||Number
2617790|NCT01976572|Secondary|T1/2|Apparent plasma terminal elimination half-life|0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose||||hr||Standard Deviation|Mean
2617791|NCT01976572|Secondary|Tmax|Time of maximum observed plasma concentration|0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose||||hr||Full Range|Median
2617792|NCT01976572|Primary|Cmax of Candesartan|Maximum observed plasma concentration|0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose|PK Population: All subjects who receive at least one dose of candesartan and have sufficient interpretable PK data.|||ng/mL||Standard Deviation|Mean
2617793|NCT01976572|Primary|AUC0-t of Candesartan|Area under the plasma concentration-time curve from time zero up to the last quantifiable time-point|0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, and 48 hours post-dose|PK Population: All subjects who receive at least one dose of candesartan and have sufficient interpretable PK data.|||ng*hr/mL||Standard Deviation|Mean
2617794|NCT01976507|Secondary|Number of Participants With Minor Bleeding Events||Within 4 months following procedure (+/- 4 days)||||Participants|||Count of Participants
2617795|NCT01976507|Secondary|Dabigatran Serum Drug Levels in Patients Experiencing a Major Bleeding or Thrombo-embolic Event.||Within 4 months following procedure (+/- 4 days)|This measure was removed from the protocol. No blood draws were done on any participants.||||||
2617796|NCT01976507|Primary|Frequency of Major Thrombo-embolic Events in Patients Administered Dabigatran Following RF Ablation.||Within 4 months following procedure (+/- 4 days)||||number of events|||Number
2617797|NCT01976507|Primary|Frequency of Major Bleeding Complications in Patients Administered Dabigatran Following RF Ablation.||Within 4 months following procedure (+/- 4 days)||||number of events|||Number
2617798|NCT01976442|Primary|Survial Rate at 5 Years|The percentage of patients who were alive at 5 years after transfusion.|5 years||||percentage of participants|||Number
2617799|NCT01976442|Primary|Survial Rate at 100 Days|The percentage of patients who were alive at 100 days after transfusion.|100 days||||percentage of participants|||Number
2617800|NCT01976442|Primary|Survial Rate at 60 Days|The percentage of patients who were alive at 60 days after transfusion.|60 days||||percentage of participants|||Number
2617801|NCT01976442|Primary|Survial Rate at 30 Days|The percentage of patients who were alive at 30 days after transfusion.|30 days||||percentage of participants|||Number
2617802|NCT01976416|Primary|Number of Malaria Episodes|Malaria is defined as the presence of P. falciparum or P. malariae on the peripheral smear of any child brought in for medical evaluation of fever. P. vivax, P. ovale and P. knowlesi are not known to be present in this region, but if a child is seen with suspected infection with any of these malaria parasites, this will also be recorded as a case of malaria. Incidence will be reported in the number of cases per 100 patient years.|12 months||||malaria episodes|person-years||Number
2617803|NCT01976338|Secondary|Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12|The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.|Baseline, months 3, 6 and 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. n=the number of patients with a value for both baseline and the specific post-baseline visit.|||Scores on a Scale||Standard Deviation|Mean
2617804|NCT01976338|Secondary|Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time|Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes|Months 3, 6 and 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)|||mm^2||Standard Deviation|Mean
2617805|NCT01976338|Secondary|Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time|Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes|Months 3, 6 and 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)|||mm^2||Standard Deviation|Mean
2617806|NCT01976338|Secondary|Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time|Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes|month 3, 6 and 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)|||mm^2||Standard Deviation|Mean
2617807|NCT01976338|Secondary|Change in Central-Sub-Field- Thickness (CSFT) Over Time|OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center|Month 1 to month 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)|||µm||Standard Deviation|Mean
2617808|NCT01976338|Secondary|Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye|Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.|Baseline to 12 months|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)|||Participants|||Number
2617809|NCT01976338|Secondary|Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters|Baseline to month 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)|||Participants|||Number
2617810|NCT01976338|Secondary|Best Corrected Visual Acuity (BCVA) Change Over Time|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline|Month 1 through Month 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)|||Letters||Standard Deviation|Mean
2617811|NCT01976338|Secondary|Average Change of Best Corrected Visual Acuity (BCVA) in Patients From Baseline to Month 1 Through Month 12|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline|Baseline to Month 1 through Month 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)|||Letters||Standard Deviation|Mean
2617812|NCT01976338|Primary|Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 6 and compared to Baseline.|Baseline to Month 1 through Month 6|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)|||Letters||Standard Deviation|Mean
2617813|NCT01976312|Secondary|The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline|The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.|Month 3,6 and 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. n= is the number of patients with a value for both baseline and the specific post-baseline visit.|||Scores on a scale||Standard Deviation|Mean
2617814|NCT01976312|Secondary|Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time|Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.|Month 1 to 12 months|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Participants|||Number
2617815|NCT01976312|Secondary|Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.|Month 1 to month 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Participants|||Number
2617816|NCT01976312|Secondary|Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time|OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center.|Month 1 to month 12|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||microns||Standard Deviation|Mean
2617817|NCT01976312|Secondary|Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline|Month 1 to 12 months|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Letters||Standard Deviation|Mean
2617818|NCT01976312|Secondary|Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline|Baseline, 12 months|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Letters||Standard Deviation|Mean
2617819|NCT01976312|Primary|Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3|"Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.~Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 3 and compared to Baseline."|Baseline, 3 Months|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Letters||Standard Deviation|Mean
2617820|NCT01976299|Secondary|Secondary Endpoint 3- Change in Kidney Function.|Change in kidney function by analyzing eGFR 3 to 5 days post procedure.|3-5 days||||mL/min/1.73m²||Standard Deviation|Mean
2617821|NCT01976299|Secondary|Secondary Endpoint 2- Comparison of Serious Adverse Events.|Comparing event rates of serious adverse events 30 days following the index procedure.|30 Days||||events|||Number
2617822|NCT01976299|Secondary|Secondary Endpoint 1-|Comparison in contrast media volume required between active treament and standard of care.|30 Days|Reduction in volume of contrast was analysed in an interim analysis once half the patient population was enrolled. Additionally, only subjects that completed the procedure were analyzed for this endpoint.|||Contrast Volume (ml)||Standard Deviation|Mean
2617823|NCT01976299|Primary|Primary Safety Endpoint- Number of Participants Experiencing a Device Related Serious Adverse Event|Analyze the incidence of device related serious adverse events within the treatment arm.|30 days||||Participants|||Count of Participants
2617824|NCT01976299|Primary|Primary Effectiveness Endpoint|Reduction in the incidence of Contrast Induced Nephropathy (CIN) by evaluating Serum Creatinine levels in subjects for up to 5 days.|3-5 days|Only subjects that completed blood draws were analyzed for this outcome.|||Participants|||Count of Participants
2618169|NCT01973062|Primary|Radiographic Response Assessed by MRI or FDG-PET/MRI|Number of patients with at least a 50% reduction in tumor size on a MRI scan with stable or decreasing dose of corticosteroids|Up to 2 years|Only one patient registered. No patient data analyzed||||||
2618170|NCT01973036|Secondary|Maternal Length of Stay From Delivery to Discharge (Hours)||Duration of hospital stay (average 3.4 days)||||hours||Inter-Quartile Range|Median
2617825|NCT01976273|Primary|Visual Analog Scale (VAS) of Improvement Rated by a Blinded Dermatologist From at Week 10|The primary outcome was a blinded rating of improvement of the treatment area (1064nm Q-switch Laser Versus Glycolic Acid Peels) using a Visual Analog Scale (VAS). A dermatologist blindly evaluated the treated areas of each side from live subjects at baseline on the final follow up visit (week 10). The VAS of improvement was rated on a scale of 0 to10, with 0 being no improvement and 10 being the most improvement seen by the treatment.|Week 10||||units on a scale||Standard Deviation|Mean
2617826|NCT01976104|Other Pre-specified|Number of Participants Experiencing an Adverse Event|Safety assessments consisted of monitoring and recording all adverse events (AEs) and serious adverse events, including platelet transfusion-related complications; routine laboratory evaluation for hematology, serum chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); the performance of physical examinations; and Doppler sonography. AE severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death related to the AE. All AEs graded as 4 or 5 were considered to be serious. Treatment-emergent adverse events (TEAEs) were defined as an AE that started on or after the date of first dose of study drug, up to 30 days after the last dose of study drug. Treatment-related AEs were considered by the investigator to be possibly or probably related to study drug.|From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years and 2 months|Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment. One participant in the High Baseline Platelet Count Cohort received 60 mg avatrombopag and hence was included in the <40×10^9/L Low Baseline Platelet Count Cohort in all safety analyses.|||Participants|||Count of Participants
2617827|NCT01976104|Other Pre-specified|Percentage of Participants With a World Health Organization (WHO) Bleeding Score Greater Than or Equal to 2 After Randomization and up to 7 Days After an Scheduled Procedure|The severity of bleeding events was assessed by the investigator (or appropriately delegated study site personnel) using the WHO bleeding scale. The WHO bleeding scale is a clinical investigator-assessed five-point scale with Grade 0 = No bleeding, Grade 1 = Petechial bleeding, Grade 2 = Mild blood loss (clinically significant), Grade 3 = Gross blood loss requires transfusion (severe), and Grade 4 = Debilitating blood loss, retinal or cerebral associated with fatality. Participants with missing information are considered as having a WHO bleeding score greater than or equal to 2 in the analysis.|Baseline (Visit 2) up to 7 days post scheduled procedure|FAS|||Percentage of participants|||Number
2617828|NCT01976104|Secondary|Change From Baseline in Platelet Counts on Scheduled Procedure Day|Last observation carried forward was used for participants with a missing platelet count on the scheduled procedure day. Platelet count was measured preprocedure and before any platelet transfusion.|Baseline (Visit 2) to Procedure Day 10 to Day 13 (Visit 4)|FAS. Only those participants with data available at both Baseline and post-Baseline were analyzed.|||platelet count x 10^9 per liter||Standard Deviation|Mean
2617829|NCT01976104|Secondary|Percentage of Participants Who Achieved a Platelet Count Greater Than or Equal to 50 x 10^9/L on Scheduled Procedure Day|Responders were defined as participants who achieved a platelet count greater than or equal to 50 x 10^9/L on the procedure day. Participants missing a platelet count on the procedure day were conservatively considered as not achieving a platelet count of 50x10^9/L in the analysis, (i.e. Non-responders).|Day 10 to Day 13 (Visit 4)|FAS|||Percentage of participants||95% Confidence Interval|Number
2617830|NCT01976104|Primary|Percentage of Participants Who Did Not Require a Platelet Transfusion After Randomization and up to 7 Days Following a Scheduled Procedure|Responders were defined as participants who did not require a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure. Participants with missing information due to early withdrawal or other reasons were conservatively considered as having received a transfusion in the analysis, (i.e. a Non-responder).|Randomization (Visit 2), up to 7 Days following a scheduled procedure|Full analysis Set (FAS) was defined as the group of all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2617831|NCT01975974|Primary|Successful First Attempt Peripheral Venous Cannulation|we will compare the first attempt success rate using proposed ultrasound technique in total of 100 obese (BMI>30) surgical patients with existing published data. Mata-analysis of first attempt success rate using ultrasound for intravenous cannulation is 61.8% We predict 90% (50% improvement) success rate using the proposed ultrasound technique. Based on this prediction, a sample size of 100 patients provided more than 90% power to compare there two groups at the 0.05 significance level with a two-sided Chi square test.|one day||||participants|||Number
2617832|NCT01975948|Other Pre-specified|Between Group Change in Sheehan Disability Scale (SDS)|The SDS is a visual analog scale which asks respondents to rate from 0-10 the extent to which symptoms have disputed: a: work/school work; b) social life/leisure activities; c) family life/home responsibilities. Total scores can range from 0-30, with lower scores indicating less disruption. We ompared between-group mean differences of SDS scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal SDS ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.|Baseline, 1, 2, 3, and 6 months|All participants with at least one follow-up data (n=116) were included in the analysis|||units on a scale||Standard Deviation|Mean
2617833|NCT01975948|Other Pre-specified|Number of Patients That Were Prescribed Antidepressant (AD) at 6 Months|We compared between group use of antidepressant in both groups using the Client Service Receipt Inventory questionnaire at 6 months.|6 months|All participants with at least one follow-up data (n=116) were included in the analysis|||Participants|||Count of Participants
2617859|NCT01975675|Secondary|Percentage of Participants Experiencing Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~- Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2617834|NCT01975948|Other Pre-specified|Between Groups Changes in Quality of Life From Baseline to 6 Months.|The Medical Outcomes Short Form (SF-36) assesses quality of life. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table.We ompared between-group mean differences of SF-36 scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal SF-36 ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.|Baseline, 1, 2, 3 and 6 months|All participants with at least one follow-up data (n=116) were included in the analysis|||units on a scale||Standard Deviation|Mean
2617835|NCT01975948|Other Pre-specified|Between Goup Change in Client Satisfaction Inventory (CSI) From Baseline to 6 Months|The CSI is a 25-item scale to measure the degree or magnitude of client satisfaction with care received. Responses range from 1 to 7. Total raw scores range from 0 to 175, with higher scores representing higher levels of satisfaction. Total scores were averaged reducing the overall score to a 7-point scale. We compared between-group mean differences of CSI scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal CSI ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.|Baseline, 1, 2,3, and 6 months|All participants with at least one follow-up data (n=116) were included in the analysis|||units on a scale||Standard Deviation|Mean
2617836|NCT01975948|Other Pre-specified|Between Group Change in Physician Confidence and Comfort With Program Specific Tools and Skills|A modified version of a British Columbia (BC) developed survey, Practice Support Program Pre-Post Learning Module Questionnaire was used. Physicians were also asked to rate their level of familiarity, confidence and comfort with a variety of non-program specific mental health tools and skills for assisting patients with mental health concerns (e.g., CBIS manual, electronic hyperlinked mental health algorithm, Bounce Back program DVD, referrals for Bounce Back telephone coaching, ASW and coaching skills, Diagnostic Assessment Interview, Problem List Action Plan, CBIS resource list, CBIS skills handout, Family Physician Guide, and medication algorithm). Physician confidence was measured on a three point scale ranging from 'very confident' to 'not at all confident. Mean scores were averaged and can range from one to three, with lower mean scores indicating higher levels of comfort, confidence and familiarity. Cronbach's alpha was .98 at pre-test and .98 at post-test|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
2617837|NCT01975948|Other Pre-specified|Between Group Change in Physician Confidence and Comfort With Non-program Specific Tools and Skills|"A modified version of a British Columbia (BC) developed survey Practice Support Program Pre-Post Learning Module Questionnaire was used. Physicians were also asked to rate their level of familiarity, confidence and comfort with a variety of non-program specific mental health tools and skills for assisting patients with mental health concerns (e.g., PHQ9 & PHQ2, AUDIT, SMME, MOCA, GAF, GAD-7). Physician confidence was measured on a three point scale ranging from 'very confident' to 'not at all confident. Mean scores were averaged and can range from one to three, with lower mean scores indicating higher levels of comfort, confidence and familiarity. Cronbach's alpha for physicia was .90 at pre-test and .91 at post-test,~3"|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
2617838|NCT01975948|Other Pre-specified|Between Group Change at 6 Months From Baseline in Physician Confidence and Comfort in Managing Mental Illness|"A modified version of a British Columbia (BC) developed survey, Practice Support Program Pre-Post Learning Module Questionnaire was used. Physician confidence was measured on a three point scale ranging from 'very confident' to 'not at all confident.' Mean scores were averaged and can range from one to three, with lower scores indicating higher confidence. Physicians were asked to their level of confidence to:~diagnose depression~screen for addictions~screen for other mental health conditions~treat depression~treat other mental health disorders~prescribe medications for mental health conditions~assess patients' problems and strengths~overall confidence in quality of mental health care provided~knowledge/awareness of non-pharmaceutical interventions~knowledge/awareness of regional mental health resources for patients~Cronbach's alpha .84 at pre-test and .87 at post-test"|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
2617839|NCT01975948|Secondary|Economic Impact|Health care costs in the two groups will be estimated using data gathered from the self report Client Service Receipt Inventory questionnaire, additional information will be obtained from Health Data Nova Scotia (HDND) registry. Administrative data will be collected from six of the HDNS registries: (1) Medical Services Insurance (MSI) Physician Billings, (2) Canadian Institute for Health Information (CIHI) Hospital Discharge Abstract Database, (3) Pharmacare Prescriptions, (4) Insured Patient Registry, (5) Patient Geography, (6) Licensed Provider Registry|January 1st, 2013 - September 31st, 2015 or end of available data||2020-12-31|12/2020||||
2617840|NCT01975948|Secondary|Between Group Changes in Occupational Functioning From Baseline to 6 Months|Lam's Employment Absence and Productivity Scale (LEAPS) is a 7 item scale that assesses workplace impact of major depression. Each item is rated on a 5-point Likert scale with the following response format: none of the time (0%), some of the time (25%), half the time (50%), most of the time (75%), or all the time (100%), scored as 0-4, respectively. Total scores can range from 0-28 with lower scores indicating less disruption.We compared between-group mean differences of LEAPs scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal LEAPs ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.|Baseline, 1, 2, 3, and 6 months|All participants with at least one follow-up data (n=116) were included in the analysis|||units on a scale||Standard Deviation|Mean
2617860|NCT01975675|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
2617841|NCT01975948|Primary|Between Group Changes in Total Score on the Opening Minds Scale for Health Care Providers (OMS-HC)|The Opening Minds Scale for Health Care Providers (OMS-HC) is a 15 item validated scale that also captures three main dimensions of stigma; negative attitudes, health professionals' own willingness to disclose/seek help for a mental illness, and preference for greater social distance. Items are rated on a 5-point scale: from strongly agree to strongly disagree. Total scores can range from 15 to 75 for the overall total score, 6 to 30, 4-29, 5-25 for sub-scales respectively. Total scores are averaged to result in mean scores range from 1 to 5 with lower scores indicating less stigma. This scale has been widely validated and used in evaluations of anti-stigma interventions in Canada. The analysis was conducted using a multi-level mixed model in which physicians were clustered within practices and stigma ratings were clustered within physicians (one or two observations per physician). The effect of the intervention was measured in this analysis as an intervention by time interaction.|Baseline and at 6 months||||units on a scale||Standard Deviation|Mean
2617842|NCT01975948|Primary|Depression Severity (Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline|The Patient Health Questionnaire-9 (PHQ-9) covers nine symptom-based Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder. Scores range from 0-27, with higher scores indicating more severe depression severity. We compared between-group mean differences of PHQ-9 scores during follow-up, assessed as a group-by-time interaction. We used a multi-level mixed model analysis: physicians clustered within practices, patients clustered within their corresponding physicians, and longitudinal PHQ-9 ratings clustered within patients. The four follow-up time points were represented by indicator variables. The effect of the intervention was measured as an intervention by time interaction, and the time-by-group interaction was assessed using a likelihood ratio test.|Baseline, 1, 2, 3, and 6 months|All participants with at least one follow-up data (n=116) were included in the analysis|||units on a scale||Standard Deviation|Mean
2617843|NCT01975935|Secondary|Change in Weight|Change in weight (kilograms) as measured at baseline and week 12 visits.|12 week|The number of participants analyzed at week 12 differs from the overall number analyzed at baseline because 1 treatment group and 3 placebo group participants dropped from the study before their week 12 visit.|||kilograms||Standard Deviation|Mean
2617844|NCT01975935|Secondary|Hepatic Steatosis as Measured by MRI|Improvement in hepatic steatosis by MRI is shown by a decrease in percent fat from baseline to week 12 visit.|12 weeks|One placebo patient was an early termination and did not have an MRI scan done at the 12 week visit. A total of 20 patients received MRI scans due to funding limitations.|||% fat||Standard Deviation|Mean
2617845|NCT01975935|Primary|Difference in Hemoglobin A1c Values|Difference in hemoglobin A1c as measured at baseline and week 12 visits|12 weeks (measured at baseline and 12 weeks)|The number of participants analyzed at week 12 differs from the overall number analyzed at baseline because 1 treatment group and 3 placebo group participants dropped from the study before their week 12 visit.|||percentage of hemoglobin glycated||Standard Deviation|Mean
2617846|NCT01975922|Secondary|Expressive Vocabulary at 4 Months After Baseline|Number of different words the child says during a 20-minute language sample.|4 months||||Number of Different words||Standard Deviation|Mean
2617847|NCT01975922|Primary|Language Skills at 4 Months After Baseline as Measured by the Pre-school Language Scale - 4th Edition|"Pre-school Language Scale - 4th Edition (a norm-referenced measure of receptive and expressive language) This scale measures the child's expressive and receptive language by going through a standard protocol of items, beginning based on the child's age, requiring a Basal of 3 consecutive correct responses and a Ceiling of 6 consecutive incorrect responses.~A higher score is considered better. A standard score of 100 is considered average for the child's age with scores ranging from 50-150."|4 months||||units on a scale||Standard Deviation|Mean
2617848|NCT01975909|Other Pre-specified|Percent Change From Baseline to Post Treatment on Mobility and Turning|"Mobility and turning is assessed by the timed up-and-go test (Podsiadlo & Richardson, 1991). The participant will be seated in an armed chair. On the word go, the subject will stand up using the arm rests if needed, walk (with assistive device if needed) around a cone placed three meters in front of the chair, return and sit down as quickly as possible."|Baseline and 1 week post treatment||||percentage change||Standard Deviation|Mean
2617849|NCT01975909|Other Pre-specified|Percent Change From Baseline to Post Treatment on Standing Postural Control|Postural control - assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during two, 30second trials of standing with eyes open on a stationary force platform (AMTI, Watertown, MA).|Baseline and 1 week post treatment||||percentage change||Standard Deviation|Mean
2617850|NCT01975909|Other Pre-specified|Percent Change From Baseline to Post Treatment on Gait Speed in 90 Second Walking Test|Two 90 second trials of walking at a preferred speed along a 80x4m indoor hallway. A wireless Noraxon DTS system (Noraxon Inc, Scottsdale, AZ) will be used simultaneously and continuously record bilateral foot placements, 3-dimensional trunk accelerations, and lower-extremity surface electromyography of eight muscles.|Baseline and 1 week post treatment||||percentage change||Standard Deviation|Mean
2617851|NCT01975909|Secondary|Percent Change From Baseline to Post Treatment on the 9-hole Peg Test|The test consists of a block with nine holes, into which the subject places and then removes 9 pegs. The time taken to complete the test will be recorded.|Baseline and 1 week post treatment||||percentage change||Standard Deviation|Mean
2617852|NCT01975909|Secondary|Percent Change From Baseline to Post Treatment on the Timed 25-Foot Walk|A quantitative assessment of mobility and leg function. Two trials of patients walking along a 25ft course as quickly and safely as possible. Time taken to complete course will be recorded and averaged across trials.|Baseline and 1 week post treatment||||percentage change of maximum gait speed||Standard Deviation|Mean
2617853|NCT01975909|Primary|Percent Change From Baseline to Post Treatment on the Scale for the Assessment and Rating of Ataxia (SARA)|Assess 8 items: gait, stance, sitting, speech, dysmetria, kinetic tremor, pro- and supinations of the hand, and the heel-shin slide. Each item is scored by the physician on a 4 to 8 numerical scale based upon the amount of dysfunction observed while performing the task. The maximum possible score for the total scale is 40. Lower scores of SARA represents better task performance.|Baseline and 1 week post treatment||||percentage change||Standard Deviation|Mean
2617854|NCT01975701|Secondary|Safety and Tolerability|Safety: type, frequency, and severity of AEs and SAEs; Tolerability: dose interruptions, reductions and dose intensity, and evaluations of laboratory values|5 years|Safety analysis set|||Participants|||Count of Participants
2617862|NCT01975675|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Treatment-naive participants in the Full Analysis Set (randomized, received at least 1 dose of study drug, and had chronic genotype 1 (1a, 1b, or mixed 1a/1b) HCV infection) without cirrhosis were analyzed.|||percentage of participants|||Number
2617863|NCT01975467|Secondary|Range of Motion and Strength|The ASES instrument will be used to assess range of motion and strength.|One time point|||||||
2617864|NCT01975467|Primary|DASH Score|Subjects that are one to three years post-treatment will undergo an evaluation of fracture outcome utilizing the DASH instrument for function.|One time point|Terminated due to low enrollment||||||
2617865|NCT01975389|Secondary|Percent Change From Baseline in Log-transformed High Sensitivity C-Reactive Protein (Hs-CRP) at Week 14||Baseline, Week 14|"Analysis was performed on FAS. Here, N signifies those participants who were evaluable for this outcome measure."|||Percent change||Standard Deviation|Mean
2617866|NCT01975389|Secondary|Percent Change From Baseline in Log-transformed Triglycerides and Lipoprotein (a) (Lp[a]) at Week 14||Baseline, Week 14|"FAS population. Here, number analyzed n signifies number of participants who were evaluable for the specified categories."|||Percent change||Standard Deviation|Mean
2617867|NCT01975389|Secondary|Percent Change From Baseline in Lipid Levels at Week 14|Lipids included non-high density lipoprotein cholesterol (non-HDL-C), very low density lipoprotein cholesterol (VLDL-C), remnant lipoprotein cholesterol (RLP-C), apolipoprotein B (Apo B), HDL-C, apolipoprotein A-I (Apo A-I) and total cholesterol.|Baseline, Week 14|"FAS population. Here, number analyzed n signifies number of participants who were evaluable for the specified categories."|||Percent change||Standard Error|Least Squares Mean
2617868|NCT01975389|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Last Post-baseline Measurement||Baseline, last post-baseline measurement (any time up to Week 140)|"Analysis was performed on FAS. Here, N signifies those participants who were evaluable for this outcome measure."|||Percent change||Standard Error|Least Squares Mean
2617869|NCT01975389|Secondary|Nominal Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 14||Baseline, Week 14|"Analysis was performed on FAS. Here, N signifies those participants who were evaluable for this outcome measure."|||mg/dL||Standard Error|Least Squares Mean
2617870|NCT01975389|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 14||Baseline, Week 14|"Analysis was performed on FAS. Here, Number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure."|||Percent change||Standard Error|Least Squares Mean
2617871|NCT01975389|Secondary|Event Rate Per 100 Participant-years for All-cause Death|Event rate per 100 participant-years for occurrence of all-cause death (adjudicated by Adjudication Committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of adjudicated and confirmed occurrence of all-cause death (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617872|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Any Arterial Revascularizations|Event rate per 100 participant-years for first occurrence of any arterial revascularizations (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of any arterial revascularizations (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617873|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Percutaneous Coronary Intervention (PCI)|Event rate per 100 participant-years for first occurrence of PCI (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of PCI (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617874|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Coronary Artery Bypass Graft Surgery (CABG)|Event rate per 100 participant-years for first occurrence of CABG (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of CABG (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617875|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Coronary Revascularization|Event rate per 100 participant-years for first occurrence of coronary revascularization (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of coronary revascularization (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617876|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Congestive Heart Failure (CHF)|Event rate per 100 participant-years for first occurrence of hospitalization for CHF (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for CHF (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617877|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Unstable Angina|Event rate per 100 participant-years for first occurrence of hospitalization for unstable angina (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617878|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Non-fatal Stroke|Event rate per 100 participant-years for first occurrence of non-fatal stroke (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of non-fatal stroke (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617879|NCT01975389|Secondary|Event Rate Per 100 Participant-years for Fatal Stroke|Event rate per 100 participant-years for occurrence of fatal stroke (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of adjudicated and confirmed occurrence of fatal stroke (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617880|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Any Stroke (Fatal or Non-fatal), of Any Etiology|Event rate per 100 participant-years for first occurrence of any stroke (fatal or non-fatal) of any etiology (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal) of any etiology (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617881|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Any Stroke (Fatal or Non-fatal)|Event rate per 100 participant-years for first occurrence of any stroke (fatal or non-fatal) (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal) (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617882|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Non-fatal Myocardial Infarction (MI)|Event rate per 100 participant-years for first occurrence of non-fatal MI (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of non-fatal MI (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617883|NCT01975389|Secondary|Event Rate Per 100 Participant-years for Fatal Myocardial Infarction (MI)|Event rate per 100 participant-years for occurrence of fatal MI (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of adjudicated and confirmed occurrence of fatal MI (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617901|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Coronary Artery Bypass Graft Surgery (CABG)|Event rate per 100 participant-years for first occurrence of CABG (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of CABG (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2617884|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Any Myocardial Infarction (Fatal or Non-fatal)|Event rate per 100 participant-years for first occurrence of any myocardial infarction (fatal or non-fatal) (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of any myocardial infarction (fatal or non-fatal) (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617885|NCT01975389|Secondary|Event Rate Per 100 Participant-years for Cardiovascular (CV) Death|Event rate per 100 participant-years for occurrence of CV death (adjudicated by Adjudication Committee) was reported. CV death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of adjudicated and confirmed occurrence of CV death (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617886|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), Non-fatal Stroke or Hospitalization for Unstable Angina|Event rate per 100 participant-years for first occurrence of composite endpoint of CV death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina (adjudicated by Adjudication Committee) was reported. CV death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of CV death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617887|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Hospitalization for Unstable Angina Needing Urgent Revascularization|Event rate per 100 participant-years for first occurrence of hospitalization for unstable angina needing urgent revascularization (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617888|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of All-cause Death, Non-fatal Myocardial Infarction (MI) or Non-fatal Stroke|Event rate per 100 participant-years for first occurrence of composite endpoint of all-cause death, non-fatal MI or non-fatal stroke (adjudicated by Adjudication Committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of all-cause death, non-fatal MI or non-fatal stroke (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617889|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of All-cause Death, Non-fatal Myocardial Infraction (MI), Non-fatal Stroke or Hospitalization for Unstable Angina Needing Urgent Revascularization|Event rate per 100 participant-years for first occurrence of composite endpoint of all-cause death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina needing urgent revascularization (adjudicated by Adjudication Committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of all-cause death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617902|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Coronary Revascularization|Event rate per 100 participant-years for first occurrence of coronary revascularization (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of coronary revascularization (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2620550|NCT01954160|Secondary|Global Longitudinal Strain|Echo: Global longitudinal strain Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2617890|NCT01975389|Secondary|Event Rate Per 100 Participant-years for First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Non-fatal Myocardial Infraction (MI) or Non-fatal Stroke|Event rate per 100 participant-years for first occurrence of composite endpoint of CV Death, non-fatal MI or non-fatal stroke (adjudicated by Adjudication Committee) was reported. CV death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of CV death, non-fatal MI or non-fatal stroke (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617891|NCT01975389|Primary|Event Rate Per 100 Participant-years for First Occurrence of Major Cardiovascular (CV) Event|Event rate per 100 participant-years for first occurrence of major CV event (adjudicated by Adjudication Committee) was reported. Major CV event was defined as any of the following: CV death [defined as sudden cardiac death, fatal myocardial infarction (MI), death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes] non-fatal MI, non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events per 100 participant-years||95% Confidence Interval|Number
2617892|NCT01975376|Secondary|Percent Change From Baseline in Log-Transformed High Sensitivity C-Reactive Protein (Hs-CRP) at Week 14||Baseline, Week 14|"Analysis was performed on FAS. Here, N signifies number of participants who were evaluable for this outcome measure."|||Percent change||Standard Deviation|Mean
2617893|NCT01975376|Secondary|Percent Change From Baseline in Log-Transformed Lipoprotein (a) (Lp[a]) and Triglycerides at Week 14||Baseline, Week 14|"Analysis was performed on FAS. Here, number analyzed n signifies number of participants who were evaluable for the specified categories."|||Percent Change||Standard Deviation|Mean
2617894|NCT01975376|Secondary|Percent Change From Baseline in Lipid Levels at Week 14|Lipids included non-high density lipoprotein cholesterol (non-HDL-C), total cholesterol, very low density lipoprotein cholesterol (VLDL-C), remnant lipoprotein cholesterol (RLP-C), apolipoprotein B (Apo B), HDL-C and apolipoprotein A-I (Apo A-I).|Baseline, Week 14|"Analysis was performed on FAS. Here, number analyzed n signifies number of participants who were evaluable for the specified categories."|||Percent Change||Standard Error|Least Squares Mean
2617895|NCT01975376|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Last Post-Baseline Measurement||Baseline, last post-baseline measurement (any time up to Week 140)|"Analysis was performed on FAS. Here, N signifies number of participants who were evaluable for this outcome measure."|||Percent Change||Standard Error|Least Squares Mean
2617896|NCT01975376|Secondary|Nominal Change From Baseline in Low Density Lipoprotein Cholesterol at Week 14||Baseline, Week 14|"Analysis was performed on FAS. Here, N signifies number of participants who were evaluable for this outcome measure."|||mg/dL||Standard Error|Least Squares Mean
2617897|NCT01975376|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 14||Baseline, Week 14|"Analysis was performed on FAS. Here, Number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure."|||Percent change||Standard Error|Least Squares Mean
2617898|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For All-Cause Death|Event rate per 100 participant-years for all-cause death (adjudicated by adjudication committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of adjudicated and confirmed occurrence of all-cause death (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2617899|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Any Arterial Revascularizations|Event rate per 100 participant-years for first occurrence of any arterial revascularizations (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of any arterial revascularizations (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2617900|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Percutaneous Coronary Intervention (PCI)|Event rate per 100 participant-years for first occurrence of PCI (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of PCI (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2618212|NCT01972841|Secondary|Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT|The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
2617903|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Hospitalization for Congestive Heart Failure (CHF)|Event rate per 100 participant-years for first occurrence of hospitalization for CHF (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for congestive heart failure (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2617904|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Hospitalization for Unstable Angina|Event rate per 100 participant-years for first occurrence of hospitalization for unstable angina (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2617905|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Non-Fatal Stroke|Event rate per 100 participant-years for first occurrence of non-fatal stroke (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of non-fatal stroke (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2617906|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For Fatal Stroke|Event rate per 100 participant-years for fatal stroke (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of fatal stroke (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2617907|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Any Stroke (Fatal or Non-Fatal), of Any Etiology|Event rate per 100 participant-years for first occurrence of any stroke (fatal or non-fatal), of any etiology (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal), of any etiology (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2617908|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Any Stroke (Fatal or Non-Fatal)|Event rate per 100 participant-years for first occurrence of any stroke (fatal or non-fatal) (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal) (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2617909|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Non-Fatal Myocardial Infarction|Event rate per 100 participant-years for first occurrence of non-fatal MI (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of non-fatal MI (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2617910|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For Fatal Myocardial Infarction|Event rate per 100 participant-years for fatal MI (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of adjudicated and confirmed occurrence of fatal MI (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2617930|NCT01975220|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Empagliflozin|AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Empagliflozin|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2617911|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Any Myocardial Infarction (Fatal or Non-Fatal)|Event rate per 100 participant-years for first occurrence of any MI (fatal or non-fatal) (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of any MI (fatal or non-fatal) (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2617912|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For Cardiovascular Death|Event rate per 100 participant-years for cardiovascular death (adjudicated by adjudication committee) was reported. Cardiovascular death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other cardiovascular causes. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of adjudicated and confirmed occurrence of cardiovascular death (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2617913|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Composite Endpoint of Cardiovascular Death, Non-Fatal Myocardial Infarction, Non-Fatal Stroke and Hospitalization for Unstable Angina|Event rate per 100 participant-years for first occurrence of composite endpoint of cardiovascular death, non-fatal MI, non-fatal stroke and hospitalization for unstable angina (adjudicated by adjudication committee) was reported. Cardiovascular death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other cardiovascular causes. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of cardiovascular death, non-fatal MI, non-fatal stroke and hospitalization for unstable angina (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2617914|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Hospitalization for Unstable Angina Needing Urgent Revascularization|Event rate per 100 participant-years for first occurrence of hospitalization for unstable angina needing urgent revascularization (adjudicated by adjudication committee) was reported. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2617915|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Composite Endpoint of All-Cause Death, Non-Fatal Myocardial Infarction, or Non-Fatal Stroke|Event rate per 100 participant-years for first occurrence of composite endpoint of all-cause death, non-fatal MI, or non-fatal stroke (adjudicated by adjudication committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of the all-cause death, non-fatal MI, or non-fatal stroke (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2617916|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Composite Endpoint of All-Cause Death, Non-Fatal Myocardial Infraction, Non-Fatal Stroke, or Hospitalization for Unstable Angina Needing Urgent Revascularization|Event rate per 100 participant-years for first occurrence of composite endpoint of all-cause death, non-fatal MI, non-fatal stroke, or hospitalization for unstable angina needing urgent revascularization (adjudicated by Adjudication Committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of all-cause death, non-fatal MI, non-fatal stroke, or hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2617931|NCT01975220|Primary|AUC 0-tz (Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point); Metformin|AUC 0-tz (area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point); Metformin|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2620551|NCT01954160|Secondary|Left Ventricular Ejection Fraction|Echo: Left Ventricular Ejection Fraction Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2617917|NCT01975376|Secondary|Event Rate Per 100 Participant-Years For First Occurrence of Composite Endpoint of Cardiovascular Death, Non-Fatal Myocardial Infraction, or Non-Fatal Stroke|Event rate per 100 participant-years for first occurrence of composite endpoint of CV death, non-fatal MI or non-fatal stroke (adjudicated by Adjudication Committee) was reported. Cardiovascular death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other cardiovascular causes. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of the CV death, non-fatal MI or non-fatal stroke (maximum duration: up to 3.4 years)|FAS: all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2617918|NCT01975376|Primary|Event Rate Per 100 Participant-Years For First Occurrence of Major Cardiovascular (CV) Event|Event rate per 100 participant-years for first occurrence of major CV event (adjudicated by Adjudication Committee) was reported. Major CV event was defined as any of the following: CV death (defined as sudden cardiac death, fatal myocardial infarction [MI], death due to heart failure, death due to stroke [fatal ischemic stroke or fatal stroke of undetermined etiology], or death due to other cardiovascular causes) non-fatal MI, non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization. Event rate was calculated as the number of events per 100 participant-years at risk.|From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years)|Full analysis set (FAS): all participants who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all participants enrolled at study Site 3027 where a quality-related event was identified.|||Events Per 100 Participant-Years||95% Confidence Interval|Number
2617919|NCT01975285|Secondary|Patient Satisfaction With Pain Management|Patient satisfaction with pain management: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied|3 days||||Scores on a scale||Standard Deviation|Mean
2617920|NCT01975285|Secondary|Patient Satisfaction With Regional Nerve Block|Patient satisfaction with regional nerve block: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied|3 days||||Scores on a scale||Standard Deviation|Mean
2617921|NCT01975285|Secondary|Length of Analgesia|Time in days and/or hours|3 days||||Hours||Inter-Quartile Range|Median
2617922|NCT01975285|Secondary|Opioid Consumption|Opioid consumption obtained from the recorded data Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts)|3 days||||Opioids consumption mg||Standard Deviation|Mean
2617923|NCT01975285|Primary|Postoperative Pain|"Postoperative pain will be measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No pain and 10 indicates= The worst possible pain"|3 days||||Scores on a scale||Standard Deviation|Mean
2617924|NCT01975246|Secondary|The Proportion of Patients With DBP<90 mmHg and SBP<140 mmHg as Seated Blood Pressure at Trough After 8 Weeks of the Double-blind Period|Patients with trough seated DBP =>90 mmHg or trough seated SBP >=140 mmHg at baseline were analysed.|baseline and week 8|FAS|||percentage of participants||95% Confidence Interval|Number
2617925|NCT01975246|Secondary|Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.|Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.|baseline and week 8|FAS|||mmHg||Standard Error|Mean
2617926|NCT01975246|Primary|Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.|Change from baseline in mean seated diastolic blood pressure (DBP) at trough after 8 weeks of the double-blind period. After patients had rested in a seated position for approximately 5 minutes, blood pressure was measured 3 times at approximately 2-minute intervals. The mean of the 3 measurements are used as endpoints.|baseline and week 8|Full analysis set (FAS): This analysis set was, conforming to the intent-to-treat principle, defined as all patients i) included in the treated set; and ii) taking measurements of seated DBP at reference baseline and at 1 or more time points during the double-blind period.|||mmHg||Standard Error|Mean
2617927|NCT01975220|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity); Metformin|AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity); Metformin|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2617928|NCT01975220|Primary|Cmax (Maximum Measured Concentration of the Analyte in Plasma); Metformin|Cmax (maximum measured concentration of the analyte in plasma); Metformin|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2617929|NCT01975220|Primary|Cmax (Maximum Measured Concentration of the Analyte in Plasma); Empagliflozin|Cmax (maximum measured concentration of the analyte in plasma); Empagliflozin|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|PKS: This set includes all subjects of the TS who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of PK endpoints.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2617932|NCT01975220|Primary|Area Under the Concentration -Time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC 0-tz); Empagliflozin|Area under the concentration -time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC 0-tz); Empagliflozin|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 20min, 1h 40min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 7h, 8h, 9h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration|Pharmacokinetic set (PKS): This set includes all subjects of the Treated set (TS) who provided at least one observation for at least one primary endpoint and had no important protocol violations with respect to the statistical evaluation of Pharmacokinetic (PK) endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2617933|NCT01975090|Secondary|Number of Participants With IVC Filter Related Complications|IVC filter related complications include, filter tilting, migration, embolization, fracture, vessel perforation, and symptomatic complications (symptomatic caval thrombosis, invasive filter intervention and filter-related death).|6months|Freedom from IVC Filter Related Complications was assessed by the site and reviewed by an Independent Core Lab. All subjects that had data collected were included in the analysis for population.|||participants|||Number
2617934|NCT01975090|Primary|Number of Subjects That Reported Clinical Success|"A Composite Endpoint including:~Technical success in deployment without acute Events; Freedom from Symptomatic Pulmonary Embolism; and Freedom from IVC filter related complications"|6 Months||||Participants|||Count of Participants
2617935|NCT01974895|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|"A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During the entire study period (Day 0 - Day 180)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.|||Subjects|||Number
2617936|NCT01974895|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|"An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010"|During a 28-day follow-up period (i.e. day of vaccination and 27 subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.|||Subjects|||Number
2617937|NCT01974895|Secondary|Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs)|"pIMDs were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject. Related pIMD was defined as a pIMD assessed by the investigator to be causally related to the study vaccination.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During the entire study period (Day 0 to Day 180)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.|||Subjects|||Number
2617938|NCT01974895|Secondary|Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)|"MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During the entire study period (Day 0 to Day 180)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.|||Subjects|||Number
2617939|NCT01974895|Secondary|Duration of Solicited Local and General Symptoms|"Duration was defined as number of days with any grade of local and general symptoms.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.|||Days||Full Range|Median
2617957|NCT01974687|Primary|Reduction in HCV RNA From Baseline on Day 8 Following Uprifosbuvir 50-450 mg for 7 Days in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)|Reduction in HCV RNA from baseline on Day 8 following uprifosbuvir 50-450 mg for 7 Days in Genotype 1, 2 and 3, HCV-infected participants was obtained.|Baseline and Day 8|Per-Protocol Population: participants who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||log10 IU/mL||Standard Deviation|Mean
2617940|NCT01974895|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Fever|"Any fever was defined as any fever ≥38.0 degrees Celsius (°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During a 4-day follow-up period (i.e. day of vaccination and 3 subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.|||Subjects|||Number
2617941|NCT01974895|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|"Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.Grade 3 fever was defined as axillary temperature above 39.0°C.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.|||Subjects|||Number
2617942|NCT01974895|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|"Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that made the subject cry when limb was moved/spontaneously painful. Grade 3 swelling was greater than 100 millimeters (mm) i.e. >100mm.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|During a 7-day follow-up period (i.e. day of vaccination and six subsequent days) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and for whom safety data were available.|||Subjects|||Number
2617943|NCT01974895|Secondary|Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Influenza Strains.|"MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria).~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
2617944|NCT01974895|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Four Vaccine Influenza Strains.|"A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria).~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects)|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2617945|NCT01974895|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains|"HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria).~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|On Day 0 and 28 days after the last vaccine (Day 28 and Day 56 for primed and unprimed subjects respectively)|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2617958|NCT01974687|Primary|Cumulative Urine Excretion of Unchanged M6 in Healthy Participants (Group A)|Cumulative urine excretion of unchanged M6 in healthy participants was obtained. All participants were fasted.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||umol||Standard Deviation|Mean
2618398|NCT01971723|Primary|Dihydrotestosterone Outcomes|Measurements for dihydrotestosterone (DHT) will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark||||ng/dL||Standard Deviation|Mean
2617946|NCT01974895|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Four Vaccine Influenza Strains.|"A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.~The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the Fluzone Group.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2617947|NCT01974895|Primary|Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of FluLaval® Quadrivalent Vaccine.|"A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.~The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the FluLaval Quadrivalent Group.~Vaccine primed subjects are subjects who had received a total of 2 or more doses of seasonal influenza vaccine since 01 July 2010.~Vaccine unprimed subjects are subjects who had never received any seasonal influenza vaccine or had received only one dose of seasonal influenza vaccine since 01 July 2010."|28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2617948|NCT01974817|Primary|Change From Baseline in Antibody Concentrations After 13-valent Conjugate Pneumococcal Vaccination in in Patients 50 Years or Older With End Stage Renal Disease on Dialysis|Study the immunologic response after administration of single dose 13-valent conjugate pneumococcal vaccine in patients 50 years or older with end stage renal disease on dialysis.|12 months||||µg/ml||95% Confidence Interval|Geometric Mean
2617949|NCT01974752|Secondary|Assessment of the Overall Survival (OS) in Patients Taking Selumetinib in Combination With Dacarbazine Compared With Those Taking Placebo in Combination With Dacarbazine|Overall Survival|From Randomization, up until death assessed up to 15th May 2015|All randomised patients and will compare the treatment groups on the basis of randomised treatment, regardless of the treatment actually received. Note, this is also known as the Full Analysis set (FAS).|||Number of Overall Survival Events|||Number
2617950|NCT01974752|Secondary|Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Change in Tumour Size at Week 6 by BICR|Percent change in tumour size at Week 6 using BICR according to RECIST 1.1|From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015|All randomised patients and will compare the treatment groups on the basis of randomised treatment, regardless of the treatment actually received. Note, this is also known as the Full Analysis set (FAS).|||percent change||Standard Deviation|Mean
2617951|NCT01974752|Secondary|Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine in Terms of Objective Response Rate (ORR) by BICR|ORR at Week 6 using BICR according to RECIST 1.1|From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015|Full Analysis Set|||number of responders|||Number
2617952|NCT01974752|Primary|Assessment of the Efficacy of Selumetinib in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine Measured as Progression Free Survival (PFS) Using BICR According to RECIST 1.1.|Progression free survival (PFS) using blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1). Progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From Randomization, then every 6 weeks up until progression or death (whichever is sooner) assessed up to 15th May 2015|All randomised patients and will compare the treatment groups on the basis of randomised treatment, regardless of the treatment actually received. Note, this is also known as the Full Analysis set (FAS).|||number of progression events|||Number
2617953|NCT01974700|Secondary|Number of Participants Who Returned to Work|The number who had returned to work in the timeframe of 6-12 months, inclusion of those that returned to part-time.|6 months - 12 months||||participants|||Number
2617954|NCT01974700|Secondary|Number of Participants Who Returned to Daily Activities.|The number who had returned to daily activities in the timeframe of 6-12 months, inclusion of those that returned to most of daily activities.|6 months - 12 months||||participants|||Number
2617955|NCT01974700|Primary|Incidence of Seizure|Reported via patient in follow-up phone call.|6 mo - 1 Year from Operative Procedure||||participants|||Number
2617956|NCT01974687|Primary|Maximum Reduction in log10 HCV RNA From Baseline - Normal Participants (From Groups B and C) vs. Mild Hepatic Impairment Participants (Group E)|Reduction in HCV RNA from baseline on Day 8 following uprifosbuvir 50-450 mg for 7 Days in Genotype (Gt) 1, HCV-infected participants was obtained.|Baseline and 28 days after last dose of study drug (Up to 42 days)|Per-Protocol Population: participants who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||log10 IU/mL||Standard Deviation|Mean
2618213|NCT01972841|Secondary|Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT|The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
2617959|NCT01974687|Primary|Cumulative Urine Excretion of Unchanged Uprifosbuvir in Healthy Participants (Group A)|Cumulative urine excretion of unchanged MK-3682 in healthy participants was obtained. All participants were fasted.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||umol||Standard Deviation|Mean
2617960|NCT01974687|Primary|t1/2 of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)|The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Geometric Coefficient of Variation|Geometric Mean
2617961|NCT01974687|Primary|t1/2 of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)|The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Geometric Coefficient of Variation|Geometric Mean
2617962|NCT01974687|Primary|t1/2 of M6 After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)|The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Geometric Coefficient of Variation|Geometric Mean
2617963|NCT01974687|Primary|t1/2 of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)|The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Geometric Coefficient of Variation|Geometric Mean
2617964|NCT01974687|Primary|t1/2 of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)|The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Geometric Coefficient of Variation|Geometric Mean
2617965|NCT01974687|Primary|t1/2 of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)|The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Geometric Coefficient of Variation|Geometric Mean
2617966|NCT01974687|Primary|t1/2 of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)|The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Geometric Coefficient of Variation|Geometric Mean
2617967|NCT01974687|Primary|t1/2 of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)|The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Geometric Coefficient of Variation|Geometric Mean
2617968|NCT01974687|Primary|t1/2 of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)|The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. All participants were fasted.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Geometric Coefficient of Variation|Geometric Mean
2617969|NCT01974687|Primary|Tmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)|Time to maximum plasma concentration was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Full Range|Median
2618399|NCT01971723|Primary|Free Testosterone Outcomes|Measurements for free testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark||||ng/dL||Standard Deviation|Mean
2617970|NCT01974687|Primary|Tmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1,HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)|Time to maximum plasma concentration was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Full Range|Median
2617971|NCT01974687|Primary|Tmax of M6 After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)|Time to maximum plasma concentration was obtained.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Full Range|Median
2617972|NCT01974687|Primary|Tmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)|Time to maximum plasma concentration was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Full Range|Median
2617973|NCT01974687|Primary|Tmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)|Time to maximum plasma concentration was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Full Range|Median
2617974|NCT01974687|Primary|Tmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)|Time to maximum plasma concentration was obtained.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Full Range|Median
2617975|NCT01974687|Primary|Tmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)|Time to maximum plasma concentration was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Full Range|Median
2617976|NCT01974687|Primary|Tmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)|Time to maximum plasma concentration was obtained.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Full Range|Median
2617977|NCT01974687|Primary|Tmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)|Time to maximum plasma concentration was obtained. All participants were fasted.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Full Range|Median
2617978|NCT01974687|Primary|Cmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)|Maximum observed plasma drug concentration was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2617979|NCT01974687|Primary|Cmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)|Maximum observed plasma drug concentration was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2617980|NCT01974687|Primary|Cmax of M6 After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)|Maximum observed plasma drug concentration was obtained.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2617981|NCT01974687|Primary|Cmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)|Maximum observed plasma drug concentration was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2617982|NCT01974687|Primary|Cmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)|Maximum observed plasma drug concentration was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2617983|NCT01974687|Primary|Cmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)|Maximum observed plasma drug concentration was obtained.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2617984|NCT01974687|Primary|Cmax of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)|Maximum observed plasma drug concentration was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2617985|NCT01974687|Primary|Cmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)|Maximum observed plasma drug concentration was obtained.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2617986|NCT01974687|Primary|Cmax of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)|Maximum observed plasma drug concentration was obtained. All participants were fasted.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2617987|NCT01974687|Primary|AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)|Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||h*umol/L||Geometric Coefficient of Variation|Geometric Mean
2617988|NCT01974687|Primary|AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)|Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||h*umol/L||Geometric Coefficient of Variation|Geometric Mean
2617989|NCT01974687|Primary|AUC0-inf of M6 After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)|Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||h*umol/L||Geometric Coefficient of Variation|Geometric Mean
2617990|NCT01974687|Primary|AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)|Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||h*umol/L||Geometric Coefficient of Variation|Geometric Mean
2617991|NCT01974687|Primary|AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)|Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||h*umol/L||Geometric Coefficient of Variation|Geometric Mean
2618214|NCT01972841|Secondary|Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT|The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 3 days prior to weeks 4, 8, 12 and EoT.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of particpants|||Number
2617992|NCT01974687|Primary|AUC0-inf of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)|Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||h*umol/L||Geometric Coefficient of Variation|Geometric Mean
2617993|NCT01974687|Primary|AUC0-inf of M6 After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)|Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||h*umol/L||Geometric Coefficient of Variation|Geometric Mean
2617994|NCT01974687|Primary|AUC0-inf of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)|Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||h*umol/L||Geometric Coefficient of Variation|Geometric Mean
2617995|NCT01974687|Primary|AUC0-inf of M6 After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)|Area under the drug concentration-time curve from time zero to infinity for M6, a metabolite of uprifosbuvir, estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only. All participants were fasted.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||h*umol/L||Geometric Coefficient of Variation|Geometric Mean
2617996|NCT01974687|Primary|t1/2 of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants, With Itraconazole (Group F)|The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Geometric Coefficient of Variation|Geometric Mean
2617997|NCT01974687|Primary|t1/2 of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)|The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Geometric Coefficient of Variation|Geometric Mean
2617998|NCT01974687|Primary|t1/2 of Uprifosbuvir After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)|The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Geometric Coefficient of Variation|Geometric Mean
2617999|NCT01974687|Primary|t1/2 of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants (Group C)|The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Geometric Coefficient of Variation|Geometric Mean
2618000|NCT01974687|Primary|t1/2 of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-infected Participants (Groups C and D)|The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Geometric Coefficient of Variation|Geometric Mean
2618001|NCT01974687|Primary|t1/2 of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-infected Participants (Group B)|The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Geometric Coefficient of Variation|Geometric Mean
2618400|NCT01971723|Primary|Bio-availableTestosterone Outcomes|Measurements for total testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark||||ng/dL||Standard Deviation|Mean
2618002|NCT01974687|Primary|t1/2 of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)|The time measured for the plasma concentration to decrease by one half (t1/2) was obtained.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Geometric Coefficient of Variation|Geometric Mean
2618003|NCT01974687|Primary|Observed Terminal Half-Life (t1/2) of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)|The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. All participants were fasted.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Geometric Coefficient of Variation|Geometric Mean
2618004|NCT01974687|Primary|Tmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants, With Itraconazole (Group F)|Time to maximum plasma concentration was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Full Range|Median
2618005|NCT01974687|Primary|Tmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)|AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Full Range|Median
2618006|NCT01974687|Primary|Tmax of Uprifosbuvir After Singe Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)|Time to maximum plasma concentration was obtained.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Full Range|Median
2618007|NCT01974687|Primary|Tmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants (Group C)|Time to maximum plasma concentration was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Full Range|Median
2618008|NCT01974687|Primary|Tmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-infected Participants (Groups C and D)|Time to maximum plasma concentration was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Full Range|Median
2618009|NCT01974687|Primary|Tmax of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-infected Participants (Group B)|Time to maximum plasma concentration was obtained.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Full Range|Median
2618010|NCT01974687|Primary|Tmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)|Maximum observed plasma drug concentration was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Full Range|Median
2618011|NCT01974687|Primary|Tmax of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)|Time to maximum plasma concentration was obtained.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Full Range|Median
2618012|NCT01974687|Primary|Time to Maximum Plasma Concentration (Tmax) of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)|Time to maximum plasma concentration was obtained. All participants were fasted.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||hours||Full Range|Median
2618078|NCT01973972|Secondary|Hypoglycemic Events|All episodes of hypoglycemia will be recorded by participants on provided standard log forms, noting the date, time, duration, symptoms, treatment received, and concurrent blood glucose. Participants will additionally be asked if they received medical attention for hypoglycemia, and the details if so, since the last assessment. Only one episode will be counted per 24 hours. Serious episodes, defined as <50 mg/dL or 50-69 mg/dL and requiring assistance, will supersede minor episodes in this case.|through 48 weeks||||events||95% Confidence Interval|Mean
2618013|NCT01974687|Primary|Cmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)|Maximum observed plasma drug concentration was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2618014|NCT01974687|Primary|Cmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)|Maximum observed plasma drug concentration was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2618015|NCT01974687|Primary|Cmax of Uprifosbuvir After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)|Maximum observed plasma drug concentration was obtained.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2618016|NCT01974687|Primary|Cmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)|Maximum observed plasma drug concentration was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2618017|NCT01974687|Primary|Cmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)|Maximum observed plasma drug concentration was obtained. All participants were fasted.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2618018|NCT01974687|Primary|Cmax of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)|Maximum observed plasma drug concentration was obtained.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2618019|NCT01974687|Primary|Cmax of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)|Maximum observed plasma drug concentration was obtained.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2618020|NCT01974687|Primary|Cmax of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)|Maximum observed plasma drug concentration was obtained.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2618021|NCT01974687|Primary|Maximum (Peak) Observed Plasma Drug Concentration (Cmax) of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)|Maximum observed plasma drug concentration was obtained. All participants were fasted.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2618022|NCT01974687|Primary|AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Tablet Formulation in Genotype 1, HCV-Infected Participants, With Itraconazole (Group F)|AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||h*umol/L||Geometric Coefficient of Variation|Geometric Mean
2618023|NCT01974687|Primary|AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)|AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||h*umol/L||Geometric Coefficient of Variation|Geometric Mean
2618079|NCT01973972|Primary|Hemoglobin A1c|measure of glycemic control|48 weeks||||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2618024|NCT01974687|Primary|AUC0-t of Uprifosbuvir After Single Dose of Uprifosbuvir as Capsule Formulation in Genotype 1, HCV-Infected Participants With Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)|AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||h*umol/L||Geometric Coefficient of Variation|Geometric Mean
2618025|NCT01974687|Primary|AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)|AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||h*umol/L||Geometric Coefficient of Variation|Geometric Mean
2618026|NCT01974687|Primary|AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)|AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||h*umol/L||Geometric Coefficient of Variation|Geometric Mean
2618027|NCT01974687|Primary|AUC0-t of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)|AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||h*umol/L||Geometric Coefficient of Variation|Geometric Mean
2618028|NCT01974687|Primary|AUC0-t of Uprifosbuvir After Multiple Doses of Uprifosbuvir Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A - Cohort 6a)|AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.|Days 1 & 7: predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||h*umol/L||Geometric Coefficient of Variation|Geometric Mean
2618029|NCT01974687|Primary|AUC0-t of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)|AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||h*umol/L||Geometric Coefficient of Variation|Geometric Mean
2618030|NCT01974687|Primary|Area Under the Plasma Drug Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Uprifosbuvir After Single Dose of Uprifosbuvir as the Capsule Formulation in Healthy Participants (Group A)|AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration. All participants were fasted.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours postdose|Pharmacokinetics (PK) Population: a subpopulation of the per-protocol population, selecting all participants exposed to uprifosbuvir who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis).|||h*umol/L||Geometric Coefficient of Variation|Geometric Mean
2618031|NCT01974687|Primary|Percentage of Participants Who Discontinued Study Drug Due to a Treatment-emergent AE|The percentage of participants who discontinued study drug due to an AE is presented.|Up to 14 days|Safety Population: all participants who received at least one dose of the study drug|||Percentage of Participants|||Number
2618032|NCT01974687|Primary|Percentage of Participants Who Experienced at Least One Treatment-emergent Grade 1, 2, 3, 4 or 5 Laboratory Abnormality|Laboratory abnormalities were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Treatment-emergent AEs (TEAEs)were graded as: Grade 1: Mild TEAE as Worst Severity; Grade 2: Moderate TEAE as Worst Severity; Grade 3: Severe TEAE as Worst Severity; Grade 4: Potentially Life-Threatening TEAE as Worst Severity; Grade 5: TEAE Leading to Death. The percentage of participants who experienced at least one Grade 1, 2, 3, 4 or 5 laboratory abnormality is presented.|Up to 42 days|Safety Population: all participants who received at least one dose of the study drug|||Percentage of Participants|||Number
2618033|NCT01974687|Primary|Percentage of Participants Who Experienced a Treatment-emergent Dose-limiting Toxicity (DLT)|A DLT was defined as any of the following events: Any SAE considered by the investigator to be at least reasonably or possibly related to study drug; Any Grade 3 clinical AE considered by the investigator to be at least reasonably or possibly related to study drug; Any Grade 3 confirmed laboratory abnormalities considered by the investigator to be at least reasonably or possibly related to study drug, except for asymptomatic Grade ¾ cholesterol and triglyceride; Any clinical or laboratory AE of any intensity that is considered by the investigator to be at least reasonably or possibly related to study drug that necessitates permanent discontinuation of study drug; Confirmed increase in QT interval corrected for heart rate using Fridericia's (QTcF) formula ≥60 msec over Baseline or an absolute QTcF ≥500 msec.|Up to 13 days|Safety Population: all participants who received at least one dose of the study drug|||Percentage of Participants|||Number
2618080|NCT01973777|Secondary|Acceptability|patient-reported acceptability|12 months||||participants|||Number
2618081|NCT01973777|Secondary|Complication|infection, perforation, pregnancy|12 months||||participants|||Number
2618034|NCT01974687|Primary|Percentage of Participants Who Experienced at Least One Treatment-emergent Serious AE (SAE)|An SAE was defined as any untoward medical occurrence that at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. The percentage of participants who experienced at least one SAE is presented.|Up to 42 days|Safety Population: all participants who received at least one dose of the study drug|||Percentage of Participants|||Number
2618035|NCT01974687|Primary|Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered study drug, and that does not necessarily have a causal relationship with the study drug(s). An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug(s), whether or not related to study drug(s). The percentage of participants who experienced at least one AE is presented.|Up to 42 days|Safety Population: all participants who received at least one dose of the study drug|||Percentage of Participants|||Number
2618036|NCT01974635|Secondary|Frisbee Test - Device|Testing proprioceptive sensation, the AMES device moves the subject's wrist through a 30 degree range, at variable speeds, as the subject attempts to identify when their wrist reaches a particular target, either by opening contact between the thumb and index finger (if possible) or blinking the eyes. The subject receives feedback about the accuracy of the testing.|After each treatment on the AMES device.|Eye-blink response device didn't perform as expected. Study terminated before any analysis performed.||||||
2618037|NCT01974635|Primary|Joint Position Test - AMES Device|Testing proprioceptive sensation, the subject, with eyes closed, attempts to identify verbally the direction of motion (i.e., flexion or extension) as the AMES device randomly moves the subject's thumb and fingers, or the whole hand, into flexion and extension.|Immediately after each treatment on the AMES Device|Device used for eye-blinks did not perform as expected. Study terminated prior to any further analyses.||||||
2618038|NCT01974323|Secondary|Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Redness on a the 5-Point ASIS Scale|The patient assessed their facial redness using item 8 on the 5-point ASIS. Item 8 scores ranged from 0 (Not at all red) to 4 (Very red). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial redness are reported.|Baseline, Week 12|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
2618039|NCT01974323|Secondary|Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Oiliness on a the 5-Point ASIS Scale|The patient assessed their facial oiliness using item 1 on the 5-point ASIS. Item 1 scores ranged from 0 (Not at all oily) to 4 (Very oily). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial oiliness are reported.|Baseline, Week 12|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
2618040|NCT01974323|Secondary|Change From Baseline in the 9-Item ASIS Sign Domain Score|The patient assessed signs of acne vulgaris using the ASIS. The sign domain is a composite of 9 items of the 17 items on the overall scale. Each of the items is assessed on a 5-point scale: 0 (best) to 4 (worst). The sign domain score is calculated as the average of the 9 items for a total possible score of 0 to 4. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 12|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
2618041|NCT01974323|Secondary|"Percentage of Patients Reporting Very Good or Excellent on Item 10 of the 5-Point Acne Symptom Impact Scale (ASIS)"|"The patient assessed the impact of their acne vulgaris on the look of their face using item 10 on the 5-point ASIS. Item 10 scores range from 1 (Excellent) to 5 (Bad). The percentage of patients who had an ASIS score of 4 (Fair) or 5 (Bad) at baseline and who reported Very good or Excellent at Week 12 are reported."|Week 12|Intent-to-Treat: all randomized patients with data at this time point|||Percentage of Patients|||Number
2618042|NCT01974323|Secondary|Percentage Change From Baseline in Total Lesion Counts|The Investigator evaluated the patient's Inflammatory (papule, pustule and nodule/cyst) and Non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative percent change from baseline indicates a reduction in lesion counts (improvement) and a positive percent change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients|||Percent Change in Lesion Count||Standard Error|Least Squares Mean
2618043|NCT01974323|Secondary|Change From Baseline in Total Lesion Counts|The Investigator evaluated the patient's inflammatory (papule, pustule and nodule/cyst) and non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients|||Total Lesion Counts||Standard Error|Least Squares Mean
2618044|NCT01974323|Primary|Change From Baseline in Noninflammatory Facial Lesion Counts|The Investigator evaluated the patient's noninflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients|||Number of Noninflammatory Lesions||Standard Error|Mean
2618045|NCT01974323|Primary|Change From Baseline in Inflammatory Facial Lesion Counts|The Investigator evaluated the patient's inflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients|||Number of Inflammatory Lesions||Standard Error|Mean
2618082|NCT01973777|Primary|Expulsion Rate|The device being expelled from the uterus as documented by ultrasound or by seeing the actual device outside the uterus|at 6-8 weeks||||participants|||Number
2618046|NCT01974323|Primary|Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS)|The Investigator evaluated the patient's acne severity using the 5-point GAAS scale with 0 being none and 4 being severe. The complete scale is as follow: Grade 0 (none) = No evidence of facila acne vulgaris; Grade 1 (minimal) = Few noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) may be present, no nodulo-cyctic lesions are allowed; Grade 2 (mild) = Several to many noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 3 (moderate) = Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 4 (severe) = Significant degree of inflammatory disease, papules/pustules are a predominant feature, a few nodulo-cystic lesions may be present, comedones may be present.|Week 12|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
2618047|NCT01974284|Secondary|Patient Satisfaction|"Patient satisfaction will be assessed by evaluating the following: pain with the Brief Pain Inventory (BPI), voice with the Voice Handicap Index (VHI) and cosmesis with the Patient and Observer Scar Assessment Scale (POSAS). The BPI is a simple, well-accepted instrument for the objective assessment of pain. The VHI is an established tool used to assess voice after an intervention. POSAS is a validated tool for the evaluation of surgical scars."|5 years|Patients were not followed as the study was terminated.||||||
2618048|NCT01974284|Secondary|Quality of Life|The Short-Form-36 (SF-36) health survey is a patient-reported survery that evaluates the patient's health status. It consists of 8 scaled scores which are the weighted sums of the questions in each section. The 8 sections that are tested are vitality, physical functioning, bodily pain, general role functioning, emotional role functioning, social role functioning, and mental health. Each scale is directly transformed into a 0-100 scale; the higher the score, the less disability (i.e. the score of 0 is equivalent to maximal disability, and the score of 100 is equivalent of no disability). The SF-36 is a set of easily-administered quality-of-life measures and is a validated tool to evaluate patient quality of life.|5 years|Patients were not followed as the study was terminated.||||||
2618049|NCT01974284|Primary|Overall Survival|Primary endpoint of the study consists of the oncological outcome, which includes the overall survival of the patients.|5 years|Patients were not followed as the study was terminated.||||||
2618050|NCT01974284|Primary|Disease-free|Primary endpoint of the study consists of the oncological outcome, which includes the disease-free status of the patients.|5 years|Patients were not followed as the study was terminated.||||||
2618051|NCT01974245|Other Pre-specified|Change From Baseline in Expression in Monocytes of Vitamin D Receptor, α 1-hydroxylase and 24-hydroxylase Enzymes, and Interleukin-6 at 12 Weeks||12 weeks|||||||
2618052|NCT01974245|Secondary|Change From Baseline in C-reactive Protein at 12 Weeks||12 weeks|||||||
2618053|NCT01974245|Primary|Change From Baseline in Interleukin-6 at 12 Weeks.||12 weeks||||pg/mL||Standard Deviation|Mean
2618054|NCT01974141|Secondary|Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Redness on a the 5-Point ASIS Scale|The patient assessed their facial redness using item 8 on the 5-point ASIS. Item 8 scores ranged from 0 (Not at all red) to 4 (Very red). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial redness are reported.|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations|||Percentage of Patients|||Number
2618055|NCT01974141|Secondary|Percentage of Patients Reporting at Least a 1-Grade Improvement From Baseline in Facial Oiliness on a the 5-Point ASIS Scale|The patient assessed their facial oiliness using item 1 on the 5-point ASIS. Item 1 scores ranged from 0 (Not at all oily) to 4 (Very oily). The percentage of patients who reported at least a 1-grade improvement from baseline in their facial oiliness are reported.|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations|||Percentage of Patients|||Number
2618056|NCT01974141|Secondary|Change From Baseline in the 9-Item ASIS Sign Domain Score|The patient assessed signs of acne vulgaris using the ASIS. The sign domain is a composite of 9 items of the 17 items on the overall scale. Each of the items is assessed on a 5-point scale: 0 (best) to 4 (worst). The sign domain score is calculated as the average of the 9 items for a total possible score of 0 to 4. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations|||Scores on a Scale||Standard Deviation|Mean
2618057|NCT01974141|Secondary|"Percentage of Patients Reporting Very Good or Excellent on Item 10 of the 5-Point Acne Symptom Impact Scale (ASIS)"|"The patient assessed the impact of their acne vulgaris on the look of their face using item 10 on the 5-point ASIS. Item 10 scores range from 1 (Excellent) to 5 (Bad). The percentage of patients who had an ASIS score of 4 (Fair) or 5 (Bad) at baseline and who reported Very good or Excellent at Week 12 are reported."|Week 12|Intent-to-Treat: all randomized patients with data at this time point, excluding patients from a site with Good Clinical Practice violations|||Percentage of Patients|||Number
2618058|NCT01974141|Secondary|Percentage Change From Baseline in Total Lesion Counts|The Investigator evaluated the patient's Inflammatory (papule, pustule and nodule/cyst) and Non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative percent change from baseline indicates a reduction in lesion counts (improvement) and a positive percent change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations|||Percent Change in Lesion Count||Standard Error|Least Squares Mean
2618083|NCT01973608|Secondary|Number of Subjects With Treatment-Emergent Adverse Events (AEs) or Serious AEs|TEAE was defined as an AE that started on or after the first administration of SBRT. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/ significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years|Safety analysis set included all subjects who signed informed consent, were enrolled into the study and received at least 1 dose of MSB0010445.|||subjects|||Number
2618059|NCT01974141|Secondary|Change From Baseline in Total Lesion Counts|The Investigator evaluated the patient's inflammatory (papule, pustule and nodule/cyst) and non-inflammatory (blackhead and whitehead) lesions. A papule is a small, red, solid elevation less than 1.0 cm in diameter, a pustule is a small, circumscribed elevation of the skin that contains yellow-white exudate and a nodule/cyst is a circumscribed, elevated, solid lesion generally more than 0.5 cm in diameter with palpable depth. The total lesion count was the sum of the inflammatory and non-inflammatory lesion counts. A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations|||Total Lesion Counts||Standard Error|Least Squares Mean
2618060|NCT01974141|Primary|Change From Baseline in Noninflammatory Facial Lesion Counts|The Investigator evaluated the patient's noninflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations|||Number of Noninflammatory Lesions||Standard Error|Mean
2618061|NCT01974141|Primary|Change From Baseline in Inflammatory Facial Lesion Counts|The Investigator evaluated the patient's inflammatory lesions (papule, pustule and nodule/cyst). A negative change from baseline indicates a reduction in lesion counts (improvement) and a positive change from baseline indicates an increase in lesion counts (worsening).|Baseline, Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations|||Number of Inflammatory Lesions||Standard Error|Mean
2618062|NCT01974141|Primary|Percentage of Patients With a Score of 0 (None) or 1 (Minimal) on the 5-point Global Acne Assessment Score (GAAS)|The Investigator evaluated the patient's acne severity using the 5-point GAAS scale with 0 being none and 4 being severe. The complete scale is as follow: Grade 0 (none) = No evidence of facila acne vulgaris; Grade 1 (minimal) = Few noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) may be present, no nodulo-cyctic lesions are allowed; Grade 2 (mild) = Several to many noninflammatory lesions (comedones) are present, a few inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 3 (moderate) = Many noninflammatory (comedones) and inflammatory lesions (papules/pustules) are present, no nodulo-cystic lesions are allowed; Grade 4 (severe) = Significant degree of inflammatory disease, papules/pustules are a predominant feature, a few nodulo-cystic lesions may be present, comedones may be present.|Week 12|Intent-to-Treat: all randomized patients, excluding patients from a site with Good Clinical Practice violations|||Percentage of Patients|||Number
2618063|NCT01974089|Primary|Re-hospitalization|The rate of re-hospitalization within 30 days of discharge|30 days after discharge||||Participants|||Count of Participants
2618064|NCT01974089|Primary|30 Day Mortality|Death within 30 days of discharge|30 days after discharge||||Participants|||Count of Participants
2618065|NCT01974089|Primary|Intra Hospital Mortality|Intra hospital mortality is death while the patient is hospitalized|With in 10 days from admission||||Participants|||Count of Participants
2618066|NCT01974050|Other Pre-specified|Pregnancy Outcome|Pregnancy outcome including termination, preterm birth, term birth or stillbirth|9 months|||||||
2618067|NCT01974050|Other Pre-specified|Pregnancy Complication|Problems reported during pregnancy|9 months|||||||
2618068|NCT01974050|Other Pre-specified|Number of Participants With a Fever in Days 0 to 2 Post-vaccination|Number of participants with any fever on days 0 to 2 post-vaccination|2 days||||Participants|||Count of Participants
2618069|NCT01974050|Secondary|Number of Women Enrollees Who Continue to Text Pregnancy-related Outcomes Through the End of Pregnancy|Feasibility of text messaging to monitor pregnancy outcomes through the end of pregnancy: Number of women enrollees who continue to text pregnancy-related outcomes through the end of their pregnancy|9 months||||Participants|||Count of Participants
2618070|NCT01974050|Secondary|Number of Participants Who Replied to Text Messaging to Assess Fever Frequency in the d0-2 Post-vaccination With IIV|Number of enrollees who text temperature-related information for the d0-2 period post-vaccination|on vaccination day and the next 2 days (D0-2)||||participants|||Number
2618071|NCT01974050|Primary|Number of Recruited Eligible Pregnant Women <20 Weeks Gestational Age|Number of eligible pregnant women <20 weeks gestational age who receive IIV who will be willing to enroll in a text messaging-based vaccine adverse event monitoring program|3 months||||Participants|||Count of Participants
2618072|NCT01973998|Other Pre-specified|Assess Tolerance of Roflumilast vs. Placebo in Hospitalized AECOPD|Reported adverse events during the course of the study. Need to withdraw study drug due to adverse events|180 days||||reported events|||Number
2618073|NCT01973998|Secondary|Respiratory Death or Respiratory Re-hospitalization|respiratory death or respiratory re-hospitalization during the 180 days post-randomization; rate of death or readmission during the 30 days post-discharge; treatment failure (see definition below); change in health status, FEV1 (forced expiratory volume at one second, and dyspnea during the 180 days post-randomization; length of hospital stay during the index hospitalization.|180 days||||number of events|||Number
2618074|NCT01973998|Primary|Time to All-cause Mortality or Re-hospitalization During the 180 Days Post-randomization.|A combined endpoint of time to all-cause mortality or re-hospitalization during the 180 days post-randomization was used.|180 days|Patients who completed 180 days of follow-up|||Days to event|Number of hospitalizations|80% Confidence Interval|Mean
2618075|NCT01973972|Secondary|Estimated Costs of Intervention Strategies|Estimates of intervention costs, utilities, direct and indirect costs using market lab cost estimates|through 48 weeks||||U.S. dollars||95% Confidence Interval|Mean
2618076|NCT01973972|Secondary|Weight|weight by electronic scale|48 weeks||||kg||Standard Deviation|Mean
2618077|NCT01973972|Secondary|Medication Effect Score|Antiglycemic medications, dosages, and schedules will be assessed carefully with the participant and updated at each visit. A Medication Effect Score (MES), based on the potencies and dosages of the medications in a patient's regimen, was devised to reflect the overall intensity of antiglycemic medication. The MES is calculated as the percentage taken of the maximum dose multiplied by the expected hemoglobin A1c lowering effect for each of a participant's medications, which are then summed. Its range is 0 to infinite, with higher scores meaning higher diabetes medication requirement.|48 weeks||||units on a scale||Standard Deviation|Mean
2618084|NCT01973608|Secondary|Number of Subjects With Best Overall Response (BOR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1|BOR was defined as a confirmed complete response (CR) or partial response (PR) during second-line treatment. For target lesions (TLs), CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For non-target lesions (NTLs), CR was defined as the disappearance of all NTLs and normalization of tumor marker levels.|Screening up to 28 days after last dose of drug; assessed up to maximum of 1.41 years|"Safety analysis set included all subjects who signed informed consent, were enrolled into the study and received at least 1 dose of MSB0010445. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||subjects|||Number
2618085|NCT01973608|Primary|Number of Subjects With at Least 1 Dose Limiting Toxicity (DLT)|DLT was defined as any Grade>= 3 toxicity related to drug, occurring during 21 days post first dose of drug except Grade 3 infusion-related adverse reaction resolving within 6 hours and Transient (<=6 hours) Grade 3 flu-like symptoms/fever controlled with medical management; Transient (<= 24 hours) Grade 3 fatigue, local reactions, headache, nausea, emesis that resolved to <= Grade 1; Grade 3 skin toxicity ,Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 8 x upper limit of normal (ULN)/total bilirubin < 5 x ULN resolving to <= Grade 1 in <7 days after medical management; Grade 3 diarrhea controlled with maximal medical management within 72 hours; Grade 4 lymphopenia that resolves to <= Grade 1 within 7 days & with no clinical manifestations; Grade 3 lab abnormality with no clinical correlation and resolves to <= Grade 1 within 7 days with adequate medical management Tumor flare defined as local pain, irritation or rash localized at sites of known/suspected tumor.|Baseline up to Day 21|Safety analysis set included all subjects who signed informed consent, were enrolled into the study and received at least 1 dose of MSB0010445.|||subjects|||Number
2618086|NCT01973595|Secondary|Diet Quality|"Three dietary recalls occurred per study arm, and each recall was scored for quality. The quality scores were averaged per arm and then compared between study arms for each subject/group using the Healthy Eating Index-2010.The Healthy Eating Index assesses diet quality based on 12 components, when summed has maximum points of 100 (HEI scale 0-100).~High component scores indicate intakes close to the recommended ranges or amounts; low component scores indicate less compliance with the recommended ranges or amounts.~National averages total score: children: 54.9 [4-8 years] and adults: 57.4 [31-50 years])"|Three week almond intervention vs. three week no almond intervention|29 Parents and 29 children were analyzed separately for almonds and no almond consumption; one parent-child pair withdrew prior to no almond consumption control.|||units on a scale||Standard Error|Mean
2618087|NCT01973595|Secondary|Gastrointestinal Function|Changes in average number of stools per week were measured using a Daily Questionnaire. Results were compared between treatment periods for each subject/group.|Pre-baseline (Week 0) and Week 3 of each intervention|29 parents and 29 children consumed almonds n=58; one parent-child pair withdrew prior to no almond consumption control intervention n=56; parents and children were analyzed for almonds and no almond consumption.|||average stools per week||Standard Error|Mean
2618088|NCT01973595|Secondary|Inflammatory Status|Levels of inflammatory markers in the blood (IL-6) were compared between baseline and final time points once the participants were on the Almonds intervention.. The data were collected at Baseline and Week four.|Change between Baseline to Week 4|Parents (Almonds baseline, n=29, final n=29, No almonds baseline n=28, final n= 28; one parent withdrew prior to no almond consumption control intervention) were analyzed for almonds and no almond consumption, no children were included in this analysis.|||ng/ml||Standard Error|Mean
2618089|NCT01973595|Primary|Gut Microbiota Community Composition|The mean of the change between baseline and final time points in stool lactic acid bacteria counts [log(CFU)] was compared for each study arm.|Baseline #1 (Week 1) to Final #1 (Week 4) of each intervention|Stool samples were analyzed only if all 4 were available from each participant. Therefore, only data from 21 parents and 20 children were analyzed.|||log (CFU)||Standard Error|Mean
2618090|NCT01973569|Secondary|Percent Change in Bone Mineral Density (BMD) From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo|The percent change from baseline in Bone Mineral Density (BMD) to month 12 was assessed. Bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA).|baseline to month 12|Bone mineral density was assessed in the Full Analysis Set.|||percent change||Standard Error|Mean
2618091|NCT01973569|Secondary|Change in Joint Space Narrowing From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo|Change from baseline in Joint Space Narrowing from baseline to month 12 was assessed. Joint Space Narrowing was defined for the sum of the joint level joint space narrowing scores among the 42 joints in both hands/wrist and both feet from radiographic assessments using the van der Heijde modified Sharp scoring method. The maximum radiographic Joint Space Narrowing from both hands/wrists and both feet is 168. Higher values represented greater damage.|baseline to month 12|Joint Space Narrowing was assessed in the Full Analysis Set.|||score on a scale||95% Confidence Interval|Mean
2618092|NCT01973569|Secondary|Change in Erosion Score From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo|Change from baseline in Erosion Score from baseline to month 12 was assessed. The Erosion Score was defined for the sum of the joint level erosion scores among the 44 joints in both hands/wrist and both feet from radiographic assessments using the van der Heijde modified Sharp scoring method. The maximum radiographic Erosion Score from both hands/wrist and both feet is 280. Higher values represented greater damage.|baseline to month 12|The Erosion Score was assessed in the Full Analysis Set.|||score on a scale||95% Confidence Interval|Mean
2618093|NCT01973569|Secondary|Change in Joint Space Narrowing From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo|Change from baseline in Joint Space Narrowing from baseline to month 6 was assessed. Joint Space Narrowing was defined for the sum of the joint level joint space narrowing scores among the 42 joints in both hands/wrist and both feet from radiographic assessments using the van der Heijde modified Sharp scoring method. The maximum radiographic Joint Space Narrowing from both hands/wrists and both feet is 168. Higher values represented greater damage.|baseline to month 6|Joint Space Narrowing was assessed in the Full Analysis Set.|||score on a scale||95% Confidence Interval|Mean
2618124|NCT01973348|Primary|Visual Acuity Change During 12 Weeks|Visual acuity change during 12 weeks: the difference of visual acuity at baseline and 12 weeks.|12 weeks|Visual acuity change over 12 weeks|||logMAR||Standard Deviation|Mean
2618125|NCT01973335|Other Pre-specified|All-cause Mortality||After 1 year of follow-up|||||||
2618094|NCT01973569|Secondary|Change in Erosion Score From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo|Change from baseline in Erosion Score from baseline to month 6 was assessed. The Erosion Score was defined for the sum of the joint level erosion scores among the 44 joints in both hands/wrist and both feet from radiographic assessments using the van der Heijde modified Sharp scoring method. The maximum radiographic Erosion Score from both hands/wrist and both feet is 280. Higher values represented greater damage.|baseline to month 6|The Erosion Score was assessed in the Full Analysis Set.|||score on a scale||95% Confidence Interval|Mean
2618095|NCT01973569|Secondary|Change in Total Sharp Score (TSS) From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo|Change from baseline in Total Sharp Score (TSS) from baseline to month 6 was assessed. The TSS was defined as the sum of the erosion score and the joint space narrowing scores from radiographic assessments. The maximum radiographic TSS from the both hands/wrists and both feet is 448. Higher values represented greater damage.|baseline to month 6|TSS was assessed in the Full Analysis Set.|||score on a scale||95% Confidence Interval|Mean
2618096|NCT01973569|Primary|Change in Total Sharp Score (TSS) From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo|Change from baseline in Total Sharp Score (TSS) from baseline to month 12 was assessed. The TSS was defined as the sum of the erosion score and the joint space narrowing scores from radiographic assessments. The maximum radiographic TSS from the both hands/wrists and both feet is 448. Higher values represented greater damage.|baseline to month 12|TSS was assessed in Full Analysis Set.|||score on a scale||95% Confidence Interval|Mean
2618097|NCT01973491|Secondary|Number of Subjects Experiencing Injection Site Reactions (ISRs)|Treatment-emergent ISRs were defined as any ISR with a start date on or after the date of first dose and within 7 days after the date of last dose in the current study. Injection site reactions were identified as erythema, induration, pruritus, nodules and/or cysts, ecchymosis, pain and local edema.|Baseline up to Week 22|The SAF Analysis Set included all subjects who received at least 1 dose of IMP.|||subjects|||Number
2618098|NCT01973491|Secondary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the date of first dose and within 28 days after the date of last dose in the current study. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline up to Week 25|The SAF Analysis Set included all subjects who received at least 1 dose of IMP.|||subjects|||Number
2618099|NCT01973491|Secondary|Change From Baseline in Total Multiple Sclerosis Functional Composite (MSFC) Score at Week 20|The MSFC is a multidimensional clinical outcome measure which consists of three sub-tests; Timed 25-Foot Walk, 9-Hole Peg Test and Paced Auditory Serial Addition Test-3(PASAT-3). The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The 9-Hole Peg Test is a quantitative measure of upper extremity (arm and hand) function. The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Standardized results (Z-scores) of these sub-tests and the overall MSFC Z-score as an average of these three Z-scores was calculated. Higher Z-scores reflect better neurological function and a positive change from baseline indicates improvement. An increase in score indicates an improvement (range -3 to +3). Baseline was defined as the last measurement taken prior to the first dose of study drug (Week 0).|Baseline (Week 0) and Week 20|"The mITT analysis set. Here, Number Analyzed signifies those subjects who were evaluable at the specified time point."|||Z-score||Standard Deviation|Mean
2618100|NCT01973491|Secondary|Change From Baseline in Total Expanded Disability Status Scale (EDSS) Score at Week 20|EDSS is an ordinal scale in half-point increments that qualifies disability in subjects with Multiple Sclerosis. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as any other neurological findings due to Multiple Sclerosis. Total EDSS score ranges from 0 (normal neurological examination) to 10 (death due to MS). Baseline was defined as the last measurement taken prior to the first dose of study drug (Week 0).|Baseline (Week 0) and Week 20|"The mITT analysis set. Here, Number Analyzed signifies those subjects who were evaluable at the specified time point."|||units on a scale||Standard Deviation|Mean
2618101|NCT01973491|Secondary|Time to First Relapse|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the subject and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Time to first relapse was defined as the time in days from the date of first dose of study treatment to the date of first multiple sclerosis relapse.|Baseline up to Week 36|The mITT analysis set included all enrolled subjects who received at least 1 dose of IMP and had 2 or more MRI scans during the Baseline Control Period and planned on-treatment visits (Weeks 12, 16, and 20) or end of treatment visit provided it occurred within 28 days of the last dose of IMP.|||days||95% Confidence Interval|Median
2618126|NCT01973335|Other Pre-specified|Incidence of Therapy-refractory Congestion|Need for combinational diuretic therapy with thiazide-type diuretics, bail-out ultrafiltration or renal replacement therapy|72h|||||||
2618127|NCT01973335|Other Pre-specified|4-point Likert Scale for Edema After 72 h||72h|||||||
2618128|NCT01973335|Other Pre-specified|4-point Likert Scale for Edema After 48 h||48h|||||||
2618129|NCT01973335|Other Pre-specified|4-point Likert Scale for Edema After 24 h||24h|||||||
2618130|NCT01973335|Other Pre-specified|Visual Analogue Scale Score for Dyspnea After 72 h||72h|||||||
2618102|NCT01973491|Secondary|Mean Annualized Relapse Rate|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the subject and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Annualized Relapse Rate was calculated as = 365.25 x (Number of relapses during Treatment Period) per (Number of days on treatment during Treatment Period).|Week 20|Analysis population included subset of mITT analysis set who had relapse.|||relapse per year||Standard Deviation|Mean
2618103|NCT01973491|Secondary|Change From Week 0 in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36|T1 CELs were measured using MRI scans.|Weeks 0, 12, 16, 20, 24, 28 and 36|The mITT analysis set. Here, “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure and “Number Analyzed” signifies those subjects who were evaluable at the specified time point.|||milliliter||Standard Deviation|Mean
2618104|NCT01973491|Secondary|Change From Week 0 in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36|T1 CELs were measured using MRI scans.|Week 0, 12, 16, 20, 24, 28 and 36|"The mITT analysis set. Here, Number of participants analyzed signifies those subjects who were evaluable for this outcome measure and Number Analyzed signifies those subjects who were evaluable at the specified time point."|||lesions||Standard Deviation|Mean
2618105|NCT01973491|Secondary|Total Number of New or Newly Enlarging Time Constant 2 (T2) Lesions|T2 lesions were measured using MRI scans.|Weeks 12, 16, 20, 24, 28 and 36|"The mITT analysis set. Here, Number Analyzed signifies those subjects who were evaluable at the specified time point."|||lesions||Standard Deviation|Mean
2618106|NCT01973491|Secondary|Change From Baseline in Total Volume of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36|T1 CELs were measured using MRI scans. Baseline was calculated as the average number of T1 CELs during the 3 visits in the Baseline Control Period (Weeks -8, -4 and 0).|Baseline (Weeks -8, -4, 0), Week 12, 16, 20, 24, 28 and 36|"The mITT analysis set. Here, Number Analyzed signifies those subjects who were evaluable at the specified time point."|||milliliter||Standard Deviation|Mean
2618107|NCT01973491|Secondary|Change From Baseline in Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) at Weeks 12, 16, 20, 24, 28 and 36|T1 CELs were measured using MRI scans. Baseline was calculated as the average number of T1 CELs during the 3 visits in the Baseline Control Period (Weeks -8, -4 and 0).|Baseline (Weeks -8, -4 and 0), Weeks 12, 16, 20, 24, 28 and 36|The mITT analysis set. Here, “Number Analyzed” signifies those subjects who were evaluable at the specified time point.|||lesions||Standard Deviation|Mean
2618108|NCT01973491|Secondary|Total Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs)|The number of T1 CELs were measured using MRI scans.|Weeks 12, 16, 20, 24, 28 and 36|The mITT analysis set. Here, “Number Analyzed” signifies those subjects who were evaluable at the specified time point.|||lesions||Standard Deviation|Mean
2618109|NCT01973491|Primary|Change From Baseline in the Average Number of Time Constant 1 (T1) Contrast-enhanced Lesions (CELs) Over On-treatment Scans|T1 CELs were measured using Magnetic Resonance Imaging (MRI) scans. Baseline value was calculated as the average number of T1 CELs during the 3 visits in the Baseline Control Period (Weeks -8, -4 and 0) and On-treatment value was calculated as the average number of T1 CELs during the 3 visits in the treatment period (Weeks 12, 16 and 20). The change from baseline in average number of T1 CELs was reported.|Baseline (Weeks -8, -4 and 0), Treatment Period (Weeks 12, 16 and 20)|The modified intention-to-treat (mITT) analysis set included all enrolled subjects who received at least 1 dose of IMP and had 2 or more MRI scans during the Baseline Control Period and planned on-treatment visits (Weeks 12, 16, and 20) or end of treatment visit provided it occurred within 28 days of the last dose of IMP.|||lesions||Standard Deviation|Mean
2618110|NCT01973439|Primary|Cmax of Abacavir on Once Daily Dosing|Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication.|Week 4||||mg/L||95% Confidence Interval|Geometric Mean
2618111|NCT01973439|Primary|AUC(0-24) of Abacavir on Once Daily Dosing|Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8, 12 and 24 hours post-ingestion of medication|Week 4||||h*mg/L||95% Confidence Interval|Geometric Mean
2618112|NCT01973439|Primary|Cmax of Abacavir on Twice Daily Dosing|Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.|Week 0||||mg/L||95% Confidence Interval|Geometric Mean
2618113|NCT01973439|Primary|Area Under Curve (AUC) (0-24) of Abacavir on Twice Daily Dosing|Blood samples were taken at 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 12 hours post-ingestion of medication.|Week 0||||h*mg/L||95% Confidence Interval|Geometric Mean
2618114|NCT01973413|Secondary|Glycemic Events|"Number of nights with >= 1 hypo- and hyperglycemic event occurring overnight during the camp study.~Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group."|6 nights|Data from OCL nights during which there were technical problems (infusion set failure, sensor error >20%, pump failure with >60-min interruption to closed-loop) were removed. Only nights with a minimum of 5h of OCL were included. For control, only data from nights where sensor error was <20% with a minimum of 5h were included.|||nights with >= 1 event|Participants||Number
2618131|NCT01973335|Other Pre-specified|Visual Analogue Scale Score for Dyspnea After 48 h||48h|||||||
2618401|NCT01971723|Primary|Insulin-like Growth Factor-I Outcomes|Measurements for insulin-like growth factor-I will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark||||ng/dL||Standard Deviation|Mean
2618115|NCT01973413|Secondary|Overnight Glucose|"Mean overnight glucose during camp study.~Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group."|6 nights|Data from OCL nights during which there were technical problems (infusion set failure, sensor error >20%, pump failure with >60-min interruption to closed-loop) were removed. Only nights with a minimum of 5h of OCL were included. For control, only data from nights where sensor error was <20% with a minimum of 5h were included.|||mg/dL|Participants|Standard Deviation|Mean
2618116|NCT01973413|Primary|Percent Time Near Normoglycemia|"Percent of time in a glucose target range of 70-150 mg/dl during camp study.~Participants were randomized to either closed-loop (experimental) or sensor-augmented pump therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session. Thus there were ~60 nights of data for each intervention. However, data from closed-loop nights during which there were technical problems such as infusion set failure, sensor error >20%, or pump failure resulting in a >60-min interruption to closed-loop control were removed to allow for analysis of algorithm performance. Only nights with a minimum of 5 hours of closed-loop were included, and all glucose data were included in the analysis. For comparison, only data from nights during which sensor error was, <20% with a minimum of 5 hours were included in the control group."|6 nights|Data from OCL nights during which there were technical problems (infusion set failure, sensor error >20%, pump failure with >60-min interruption to closed-loop) were removed. Only nights with a minimum of 5h of OCL were included. For control, only data from nights where sensor error was <20% with a minimum of 5h were included.|||percentage of time|Participants|Inter-Quartile Range|Median
2618117|NCT01973387|Secondary|Number of Participants With Clinically Relevant Shifts in Disease-Related Symptoms|The most common disease-related symptoms associated with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) (fatigue, weight loss, fevers, night sweats, and abdominal discomfort/splenomegaly) were reported by grade.|From the date of randomization to disease progression (Up to 3.7 years)|Intent-to-Treat (ITT) analysis set is defined as all participants randomized into the study and analyzed according to assigned treatment group, regardless of the actual treatment received.|||participants|||Number
2618118|NCT01973387|Secondary|Number of Participants With Sustained Hematologic Improvement|Sustained hematologic improvement was defined as hematological improvement that was sustained continuously for greater than or equal to (>=) 56 days without blood transfusion or growth factors: 1) Platelet counts greater than (>)100* 109/liter (L) if baseline less than or equal to (<=) 100*109/L or increase >= 50 percent (%) over baseline; 2) Hemoglobin >11 gram per deciliters (g/dL) if baseline <= 11 g/dL or increase >= 2 g/dL over baseline.|From the date of randomization to disease progression (Up to 3.7 years)|Intent-to-Treat (ITT) analysis set is defined as all participants randomized into the study and analyzed according to assigned treatment group, regardless of the actual treatment received.|||participants|||Number
2618119|NCT01973387|Secondary|Overall Survival (OS)|Overall survival was defined as the interval between the date of randomization and the date of death from any cause.|From the date of randomization to the date of death (Up to 3.7 years)|Intent-to-Treat (ITT) analysis set is defined as all participants randomized into the study and analyzed according to assigned treatment group, regardless of the actual treatment received.|||months||95% Confidence Interval|Median
2618120|NCT01973387|Secondary|Overall Response Rate (ORR)|ORR defined as number of participants achieving a complete response (CR), complete response with incomplete marrow recovery (CRi), nodular partial response (nPR) or partial response (PR). IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils >1.5*10^9/liter (L), platelets >100*10^9/L, Hgb >11 gram per deciliter (g/dL) and absolute lymphocyte count <4000/microliter (mcL); CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, may represent a clonal infiltrate; PR- >=50% drop in lymphocyte count from baseline or <=4.0*10^9/L with following: >=50% decrease in sum products of up to 6 lymph nodes, no new enlarged lymph nodes, When abnormal, >=50% decrease in enlargement of spleen from baseline or normalization and a response in 1 of following: Neutrophils >1.5*10^9/L, Platelets>100000/mcL and Hgb>11 g/dL or >=50% improvement over baseline in all.|From the date of randomization to disease progression (Up to 3.7 years)|Intent-to-Treat (ITT) analysis set is defined as all participants randomized into the study and analyzed according to assigned treatment group, regardless of the actual treatment received.|||participants|||Number
2618121|NCT01973387|Primary|Progression-free Survival (PFS)|Progression-free survival was defined as the interval between the date of randomization and the date of disease progression or death, whichever was first reported. International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for progressive disease (PD): New enlarged nodes greater than (>)1.5 centimeter (cm), new hepatomegaly or splenomegaly, or other organ infiltrates; greater than or equal to (>=)50 percent (%) increase from nadir in existing lymph node or >=50% increase from nadir in sum of product of diameters of multiple nodes; >=50% increase from nadir in enlargement of liver or spleen; >=50% increase from baseline in lymphocyte count (and to >=5*10^9/L) unless considered treatment-related lymphocytosis; New cytopenia (Hemoglobin b [Hgb] or platelets) attributable to chronic lymphocytic leukemia (CLL) and transformation to a more aggressive histology.|From the date of randomization to the date of disease progression or death, whichever was first reported (Up to 3.7 years)|Intent-to-Treat (ITT) analysis set is defined as all participants randomized into the study and analyzed according to assigned treatment group, regardless of the actual treatment received.|||months||95% Confidence Interval|Median
2618122|NCT01973348|Other Pre-specified|Significant Ocular Deviation Increase From the Baseline|The significant ocular deviation is defined as equal or over 10 degrees of deviation more than that of the baseline.|3 Months||||Participants|||Count of Participants
2618123|NCT01973348|Other Pre-specified|Reverse Amblyopia|it is defined that the strong eye of the patient decreases two logMAR lines over 3 months.|3 Months||||Participants|||Count of Participants
2618132|NCT01973335|Other Pre-specified|Visual Analogue Scale Score for Dyspnea After 24 h|Scale name and construct: Visual analogue scale presented as a line with a movable indicator. Far left of the line indicates no dyspnea at all and far right of the line indicates the worst imaginable dyspnea. The participant can move the indicator to one certain point among the line and the investigator can read at the back a number going from 0 to 100 with 0 indicating no dyspnea and 100 the worst imaginable dyspnea.|24h|||||||
2618133|NCT01973335|Other Pre-specified|Weight Change After 72 h|Body weight change after 72 h compared to admission.|72h|||||||
2618134|NCT01973335|Other Pre-specified|Diuresis 72 h|Total amount of urine output (L) after 72 h.|72h|||||||
2618135|NCT01973335|Other Pre-specified|Diuresis 48 h|Total amount of urine output (L) after 48 h.|48h|||||||
2618136|NCT01973335|Other Pre-specified|Diuresis 24 h|Total amount of urine output (L) after 24 h.|24h|||||||
2618137|NCT01973335|Other Pre-specified|Natriuresis 72 h|Total natriuresis (mmol) after 72 h.|72h|||||||
2618138|NCT01973335|Other Pre-specified|Natriuresis 48 h|Total natriuresis (mmol) after 48 h.|48h|||||||
2618139|NCT01973335|Secondary|Peak Plasma Renin Activity After 72 h|At three consecutive mornings after study inclusion, blood samples will be taken to assess plasma renin activity. The highest value will constitute the peak plasma renin activity (ng/mL/h).|72h||||µg/L/h||Inter-Quartile Range|Median
2618140|NCT01973335|Secondary|Peak Plasma Aldosterone Concentration After 72 h|At three consecutive mornings after study inclusion, blood samples will be taken to assess plasma aldosterone levels. The highest value will constitute the peak plasma aldosterone concentration (ng/L).|72h||||ng/L||Inter-Quartile Range|Median
2618141|NCT01973335|Secondary|Persistent Renal Impairment|Persistent renal impairment is defined as a persistently elevated serum creatine >0.3mg/dL or >20% decrease in estimated glomerular filtration rate by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, above the baseline value of the patient and will be assessed on a scheduled follow-up appointment 4 weeks after hospital discharge.|4 weeks after hospital discharge|9 patients died or were too sick for follow-up appointment; 9 refused a venous blood sample at the follow-up appointment (protocol violation)|||Participants|||Count of Participants
2618142|NCT01973335|Secondary|Number of Participants With Worsening Renal Function|Worsening renal function is defined as a rise in serum creatine >0.3 mg/dL or a >20% decrease in estimated glomerular filtration rate by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula compared to baseline at any time point before 72 h. Serum creatinine values are assessed at three consecutive mornings after study inclusion.|72h||||Participants|||Count of Participants
2618143|NCT01973335|Secondary|NT-proBNP Change After 72 h|Relative NT-proBNP change (%) after 72 h compared to baseline.|72h||||percentage change from baseline||Standard Deviation|Mean
2618144|NCT01973335|Primary|Spironolactone Arm: Incidence of Hypo- (Serum Potassium <3.5 mmol/L) or Hyperkalemia (Serum Potassium >5.0 mmol/L)|For the spironolactone arm of the study, the primary end-point is the incidence of either hypo- (serum potassium <3.5 mmol/L) or hyperkalemia (serum potassium >5.0 mmol/L) at any of 3 morning blood samples at consecutive days after randomization. Patients receiving upfront spironolactone (both the group receiving acetazolamide+low dose loop diuretics and the group receiving high-dose loop diuretic therapy) are compared with them receiving no spironolactone (both the group receiving acetazolamide+low dose loop diuretics and the group receiving high-dose loop diuretic therapy).|72h||||Participants|||Count of Participants
2618145|NCT01973335|Primary|Acetazolamide Arm: Natriuresis 24 h|For the acetazolamide arm of the study, the primary end-point is total natriuresis after 24 h (mmol). To assess this, urine is collected for 24 h after the first administration of diuretics according to the study protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L). Subsequently, patients receiving acetazolamide and low-dose loop diuretics (both the groups with and without upfront spironolactone together) are compared to patients not receiving acetazolamide but high-dose loop diuretics instead (both the groups with or without upfront spironolactone together)|24h|2 patients not analysed because of errors with 24 h urinary collection|||mmol||Standard Deviation|Mean
2618146|NCT01973231|Secondary|Number of Treatment Emergent Adverse Events (TEAEs)|A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.|Weeks 0-26|The safety analysis set (SAS) included all subjects who received at least one dose of any of the trial products.|||events|||Number
2618147|NCT01973231|Secondary|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) and no Weight Gain (Yes/no)|Subjects who achieved HbA1c below 7.0% (53 mmol/mol) and no weight gain after 26 weeks of treatment (yes/no).|After 26 weeks of treatment|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing HbA1c post-baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.|||percentage (%) of subjects|||Number
2618148|NCT01973231|Secondary|Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) (American Association of Clinical Endocrinologists [AACE] Target) (Yes/no)|Subjects who achieved HbA1c below equal to or below 6.5% (48 mmol/mol) after 26 weeks of treatment (yes/no).|After 26 weeks of treatment|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing HbA1c post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.|||percentage (%) of subjects|||Number
2618149|NCT01973231|Secondary|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association (ADA) Target) (Yes/no)|Subjects who achieved HbA1c below 7.0% (53 mmol/mol) after 26 weeks of treatment (yes/no).|After 26 weeks of treatment|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing HbA1c post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.|||percentage (%) of subjects|||Number
2618150|NCT01973231|Secondary|Change in Body Weight From Baseline|Change from baseline in body weight after 26 weeks of treatment.|Week 0, week 26|The FAS included all randomised subjects. Missing values were imputed using predicted values from the MMRM model. Due to missing body weight post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the body weight analysis.|||kg||Standard Deviation|Mean
2618152|NCT01973231|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects. Missing values were imputed using predicted values from the mixed model for repeated measurements (MMRM) model. Due to missing HbA1c post baseline data, 194 and 191 subjects in liraglutide and lixisenatide treatment group, respectively were included in the HbA1c analysis.|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
2618153|NCT01973218|Secondary|The Number of Subjects Reporting Unsolicited AEs After Any Vaccination, by Vaccine Group.|The number of subjects reporting any unsolicited AEs, serious adverse events (SAEs), AEs leading to premature withdrawal and medically attended AEs (throughout the study), following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.|Day 1 through Day 61|Analysis was done on the safety set for solicited AEs i.e all subjects in the Exposed Set who received the correct vaccination and provide post vaccination reactogenicity data.|||number of subjects|||Number
2618154|NCT01973218|Secondary|The Number of Subjects Reporting Solicited Adverse Events After Each Study Vaccination, by Vaccine Group.|The number of subjects reporting solicited local and systemic adverse events (AEs) following rMenB+OMV NZ vaccination or placebo/MenACWY-CRM, are reported.|Day 1 through day 7 after each vaccination|Analysis was done on the safety set for solicited AEs i.e all subjects in the Exposed Set who received the correct vaccination and provide post vaccination reactogenicity data.|||Number of subjects|||Number
2618155|NCT01973218|Secondary|The GMR of Post Versus Pre-vaccination ELISA GMCs Against Vaccine Antigen 287-953, by Vaccine Groups.|The GMR of post versus pre-vaccination GMCs against vaccine antigen 287-953, measured by ELISA at one month after second vaccination (day 61/day 1) are reported for each group.|Day 61/Day 1|Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.|||Ratio||95% Confidence Interval|Geometric Mean
2618156|NCT01973218|Secondary|The ELISA Geometric Mean Concentrations (GMCs) Against Vaccine Antigen 287-953, by Vaccine Group.|The GMCs against vaccine antigen 287-953 was measured by Enzyme-linked Immunosorbent Assay (ELISA) , at one month after second vaccination and are reported for each group.|Day 1 and Day 61|Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints|||IU/mL||95% Confidence Interval|Geometric Mean
2618157|NCT01973218|Secondary|The Percentages of Subjects With a Four-fold Increase in SBA Antibody Titers Against N.Meningitidis Serogroup B, by Vaccine Group.|Percentages of subjects with a four-fold increase in SBA antibody titers from baseline against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination are reported, for each group.|Day 61|Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.|||percentage of subjects||95% Confidence Interval|Number
2618158|NCT01973218|Secondary|The Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination SBA Titers Against N.Meningitidis Serogroup B, by Vaccine Group.|The GMR of post-vaccination versus pre-vaccination SBA titers against each of the three indicator strains of N.Meningitidis serogroup B, at one month after second vaccination (day 61/day 1) are reported, for each group.|Day 61/ Day 1|Analysis was done on the FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints|||Ratio||95% Confidence Interval|Geometric Mean
2618159|NCT01973218|Secondary|The SBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B, by Vaccine Group.|The SBA antibody titers against each of the three indicator strains of N.Meningitidis serogroup B at one month after second vaccination are reported as GMTs, for each group.|Day 1 and Day 61|Analysis was done on FAS population, i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.|||Titers||95% Confidence Interval|Geometric Mean
2618160|NCT01973218|Primary|Percentage of Subjects With Serum Bactericidal Antibody (SBA) Titers ≥1:4 Against Neisseria Meningitidis Serogroup B by Vaccine Group.|Percentage of subjects with SBA titers ≥1:4 against each of the three indicators strains H44/76, 5/99 and NZ98/254 of N. Meningitidis serogroup B, at one month after second vaccination, are reported for each group.|Day 1 and Day 61|Analysis was done on the Full Analysis Set (FAS) i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.|||percentage of subjects||95% Confidence Interval|Number
2618161|NCT01973205|Secondary|Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment.|Number of subjects who are free of phonophobia at the 2-hour assessment.|2 hours|Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing phonophobia free status at 2 hours (AA: N=403, Placebo: N = 411).|||participants|||Number
2618162|NCT01973205|Secondary|Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment.|Number of subjects who are free of photophobia at the 2-hour assessment.|2 hours|Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing photophobia free status at 2 hours (AA: N=403, Placebo: N = 411).|||participants|||Number
2618163|NCT01973205|Primary|Number of Subjects Who Are Nausea Free at the 2-hour Assessment|Number of subjects who are nausea free at the 2-hour assessment|2 hours|Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N=415) and had a non-missing nausea free status at 2 hours (AA: N=403, Placebo N= 411).|||participants|||Number
2618164|NCT01973205|Primary|Number of Subjects Who Are Pain Free at the 2-hour Assessment|Number of subjects who are pain free at the 2-hour assessment|2 hours|Number of participants analyzed includes only subjects who treated a migraine (AA: N=408, Placebo: N = 415) and had a non-missing pain free status at 2 hours (AA: N=408, Placebo: N = 415).|||participants|||Number
2618165|NCT01973062|Secondary|Dosimetry Calculations of Yttrium Y 90 Ibritumomab Tiuxetan Assessed by PET/MRI|Number of Gy delivered to each tumor as calculated using the MIRD dosimetry formula on PET data|At day 11|Only one patient registered. No patient data analyzed||||||
2618166|NCT01973062|Secondary|Establish the Toxicity Profile of Ibritumomab Tiuxetan in This Patient Population.|Number of patients with toxicities related to the study drug|Up to 30 days following the last dose of study treatment|Only one patient registered. No patient data analyzed||||||
2618167|NCT01973062|Secondary|Overall Survival|The number of patients alive up to two years after treatment|Up to 2 years|Only one patient registered. No patient data analyzed||||||
2618171|NCT01973036|Secondary|Rate of Chorioamnionitis|Chorioamnionitis defined as (Temperature greater than or equal to 100.4 degrees fahrenheit or 38 degrees celsius) with at least 2 of the following: uterine tenderness, maternal tachycardia (HR greater than or equal to 100 bpm), fetal tachycardia (HR greater than or equal to 160bpm), foul odor of the amniotic fluid, or maternal leukocytosis (greater than 15000 cells/cubic milliliter)|Duration of hospital stay (average 3.4 days)||||Participants|||Count of Participants
2618172|NCT01973036|Secondary|Overall Cesarean Delivery||Duration of hospital stay (average 3.4 days)||||Participants|||Count of Participants
2618173|NCT01973036|Secondary|Time From Induction to Delivery (Hours)|Time from induction to delivery (hours) excluding all those who were hospitalized with PPROM prior to 34 0/7 weeks|Time from induction to delivery (average 14.2 hours)||||hours||Standard Deviation|Mean
2618174|NCT01973036|Secondary|Number of Participants With Confirmed Histologic Chorioamnionitis/Funisitis|Chorioamnionitis/funisitis as determined by the pathologist examining the placenta|Duration of hospital stay (average 3.4 days)||||Participants|||Count of Participants
2618175|NCT01973036|Secondary|Neonatal Length of Stay||Duration of hospital stay (average 3.4 days)||||hours||Standard Deviation|Median
2618176|NCT01973036|Secondary|Neonatal Intensive Care Unit (NICU) Admission Rate||Duration of hospital stay (average 3.4 days)||||Participants|||Count of Participants
2618177|NCT01973036|Secondary|Rate of Neonatal Sepsis|Neonatal sepsis [positive blood or cerebrospinal fluid (CSF) cultures]|Duration of hospital stay (average 3.4 days)||||Participants|||Count of Participants
2618178|NCT01973036|Secondary|Arterial Cord Blood Gas (pH), When Obtained||Within 1 hour of delivery||||pH||Standard Deviation|Mean
2618179|NCT01973036|Secondary|Rate of Five Minute Apgar Score < 5|Apgar is a test for assessing a newborn shortly after birth to determine if extra medical care or emergency care may be needed. Usually administered at 1 and 5 minutes after birth, the test includes assessment of Appearance, Pulse, Grimace, Activity and Respiration. Scores range from 0 - 10.|Duration of hospital stay (average 3.4 days)||||Participants|||Count of Participants
2618180|NCT01973036|Secondary|Maternal Length of Stay, From Admission to Discharge (Days)||Duration of hospital stay (average 3.4 days)||||days||Inter-Quartile Range|Median
2618181|NCT01973036|Secondary|Rate of Endomyometritis|Endomyometritis defined as: Temperature ≥100.4°F + one of the following: fundal tenderness, maternal tachycardia (Heart Rate ≥ 100 BPM), purulent cervical discharge and no other source of fever|Duration of hospital stay (average 3.4 days)||||Participants|||Count of Participants
2618182|NCT01973036|Secondary|Rate of Failed Induction of Labor as the Indication for Cesarean|"This will be defined by a combination of provider documentation and cervical dilation of ≤4cm/90% effaced or ≤5cm/any effacement after a minimum of 12 hours of oxytocin in the setting of adequate contraction.~One patient was missing information for failed induction."|Duration of Labor (average 4.8 hours)||||Participants|||Count of Participants
2618183|NCT01973036|Secondary|Duration of First, Second and Third Stage of Labor (Minutes) for Those Undergoing Vaginal Deliveries||Duration of Labor (average 4.8 hours)||||Minutes||Inter-Quartile Range|Median
2618184|NCT01973036|Secondary|Number of Participants With Vaginal Delivery Within 24 Hours From Placement of Foley Catheter or Start Time of Oxytocin||Duration of Labor (average 4.8 hours)||||Participants|||Count of Participants
2618185|NCT01973036|Secondary|Number of Participants With Vaginal Delivery Within 12 Hours From Placement of Foley Catheter or Start Time of Oxytocin||Duration of Labor (average 4.8 hours)||||Participants|||Count of Participants
2618186|NCT01973036|Secondary|Number of Participants With Chorioamnionitis|"Number of participants with chorioamnionitis excluding all those who were hospitalized with preterm premature rupture of membranes (PPROM) prior to 34 0/7 weeks. Chorioamnionitis was defined as temperature 38°C (or 100.4°F) or greater with at least two of the following: purulent discharge, maternal tachycardia (heart rate 100 beats per minute or greater), fetal tachycardia (heart rate 160 beats per minute or greater), foul odor of the amniotic fluid, or maternal leukocytosis (greater than 15,000 cells/mL3).~Without Restriction = Chorioamnionitis was defined as temperature 38°C or greater and one of the following: purulent discharge, maternal tachycardia, fetal tachycardia, foul odor of the amniotic fluid, or maternal leukocytosis.~With Restriction = Chorioamnionitis was defined as temperature 38°C or greater and two of the following: purulent discharge, maternal tachycardia, fetal tachycardia, foul odor of the amniotic fluid, or maternal leukocytosis."|Duration of Labor (average 4.8 hours)|The number of participants analyzed excludes patients who were hospitalized with PPROM prior to 34 0/7 weeks (i.e., four patients in the Oxytocin arm and six patients in the Foley Catheter arm).|||Participants|||Count of Participants
2618187|NCT01973036|Primary|Time From Induction of Labor Until Delivery|Time from induction (i.e., start time of Foley catheter or oxytocin) to delivery (hours), analyzed for all deliveries|Time from induction to delivery (average 14.2 hours)||||hours||Standard Deviation|Mean
2618188|NCT01972841|Secondary|Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||bpm||Standard Error|Least Squares Mean
2618189|NCT01972841|Secondary|Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||nnHg||Standard Error|Least Squares Mean
2618190|NCT01972841|Secondary|Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||mmHg||Standard Error|Least Squares Mean
2618191|NCT01972841|Secondary|Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. Only participants with an increase (i.e., maximum 1-hour change from time-matched baseline ≥ 0 mmHg) were included in the analysis. LOCF was used for EoT.|||bpm||Standard Error|Least Squares Mean
2618192|NCT01972841|Secondary|Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. Only participants with an increase (i.e., maximum 1-hour change from time-matched baseline ≥ 0 mmHg) were included in the analysis. LOCF was used for EoT.|||mmHg||Standard Error|Least Squares Mean
2618193|NCT01972841|Secondary|Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. Only participants with an increase (i.e., maximum 1-hour change from time-matched baseline ≥ 0 mmHg) were included in the analysis. LOCF was used for EoT.|||mmHg||Standard Error|Least Squares Mean
2618194|NCT01972841|Secondary|Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||bpm||Standard Error|Least Squares Mean
2618195|NCT01972841|Secondary|Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||mmHg||Standard Error|Least Squares Mean
2618196|NCT01972841|Secondary|Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax (time to maximum concentration) window of mirabegron and solifenacin was from 4-6 hours postdose.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||mmHg||Standard Error|Least Squares Mean
2618197|NCT01972841|Secondary|Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)|Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2618198|NCT01972841|Secondary|Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)|Vital signs (blood pressure and pulse rate) were monitored using ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||mmHg||Standard Error|Least Squares Mean
2618199|NCT01972841|Secondary|Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)|Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.|Baseline and weeks 4, 12 and EoT (up to 12 weeks)|ABPM analysis set (ABPMAS), which consisted of all participants in the SAF for whom at least 1 ABPM variable could be calculated at baseline and postbaseline visit. Participants with data available at each time point were included in the analysis. LOCF was used for EoT.|||mmHg||Standard Error|Least Squares Mean
2618200|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume|PVR volume was assessed by ultrasonography or a bladder scanner.|Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|SAF participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||mL||Standard Deviation|Mean
2618215|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8 and 12 in TS-VAS|The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.|Baseline and week 4, 8 and 12|FAS participants with available data at each time point were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2618216|NCT01972841|Secondary|Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment||Baseline and week 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with both baseline and post-baseline values were included in the analysis.|||percentage of activity impairment||Standard Deviation|Mean
2618201|NCT01972841|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE refered to an adverse event (AE; defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment) which started or worsened in the period from first double-blind medication intake until 14 days after the last double-blind medication intake. Serious TEAEs with a start date reported until 30 days after the last double-blind medication intake were also summarized as TEAEs, and also included serious TEAEs upgraded by the sponsor based on review of the sponsor's list of Always Serious terms if any upgrade was done. Drug-related TEAEs may be possible or probable, as assessed by the investigator, or records where relationship is missing.|From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 16 weeks)|Safety Analysis Set (SAF), which comprised all randomized participants who received ≥ 1 dose of double-blind treatment and excluded participants from one site.|||Participants|||Count of Participants
2618202|NCT01972841|Secondary|Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT|The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the HRQL total score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
2618203|NCT01972841|Secondary|Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT|The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
2618204|NCT01972841|Secondary|Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT|The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
2618205|NCT01972841|Secondary|Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT|The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q HRQL total score at weeks 4, 8, 12 and EoT.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
2618206|NCT01972841|Secondary|Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT|The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score at weeks 4, 8, 12 and EoT.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
2618207|NCT01972841|Secondary|Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT|The percentage of participants with a major (≥ 2 points) improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
2618208|NCT01972841|Secondary|Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT|The percentage of participants with ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
2618209|NCT01972841|Secondary|Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT|The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 7 days prior to weeks 4, 8, 12 and EoT.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
2618210|NCT01972841|Secondary|Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT|The percentage of participants with micturition frequency normalization was defined as any participant who had ≥ 8 micturitions/24 hours at baseline and < 8 micturitions/24 h postbaseline at weeks 4, 8, 12 and EoT.|Weeks 4, 8 , 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
2618211|NCT01972841|Secondary|Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT|The percentage of participants with ≥ 50% decrease from baseline in mean number of incontinence episodes per 24 hours at each time point (weeks 4, 8, 12 and EoT).|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
2618290|NCT01972776|Primary|Change From Baseline in Lung Clearance Index (LCI) (Part 2)||Baseline, 8 weeks|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
2618217|NCT01972841|Secondary|Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment||Baseline and week 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with both baseline and post-baseline values were included in the analysis.|||percentage of overall work impairment||Standard Deviation|Mean
2618218|NCT01972841|Secondary|Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working||Baseline and week 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with both baseline and post-baseline values were included in the analysis.|||percentage of impairment while working||Standard Deviation|Mean
2618219|NCT01972841|Secondary|Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed|The WPAI:SHP was a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.|Baseline and week 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with both baseline and post-baseline values were included in the analysis.|||percentage of work time missed||Standard Deviation|Mean
2618220|NCT01972841|Secondary|Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression|The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and EoT (up to 12 weeks)|FAS participants with available data were included in the analysis. LOCF was used for EoT.|||participants|||Number
2618221|NCT01972841|Secondary|Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort|The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and EoT (up to 12 weeks)|FAS participants with available data were included in the analysis. LOCF was used for EoT.|||participants|||Number
2618222|NCT01972841|Secondary|Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities|The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and EoT (up to 12 weeks)|FAS participants with available data were included in the analysis. LOCF was used for EoT.|||participants|||Number
2618223|NCT01972841|Secondary|Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care|The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and EoT (up to 12 weeks)|FAS participants with available data were included in the analysis. LOCF was used for EoT.|||participants|||Number
2618224|NCT01972841|Secondary|Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility|The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).|Baseline and EoT (up to 12 weeks)|FAS participants with available data were included in the analysis. LOCF was used for EoT.|||participants|||Number
2618225|NCT01972841|Secondary|PGIC Scale: Impression in General Health at Week 12 and EoT|The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).|Week 12 and EoT (up to 12 weeks)|FAS participants with available data were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
2618226|NCT01972841|Secondary|Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT|The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).|Week 12 and EoT (up to 12 weeks)|FAS participants with available data were included in the analysis. LOCF was used for EoT.|||percentage of participants|||Number
2618227|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social|The Social score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
2618228|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep|The Sleep score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
2618291|NCT01972776|Primary|Percentage of Participants With Adverse Events (Part 1)|Adverse events were counted and corresponding percentages were tabulated.|14 days|All randomized part 1 participants|||percentage of participants|||Number
2618229|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern|The Concern score was calculated by adding 7 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
2618230|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping|The Coping score was calculated by adding 8 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
2618231|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score|The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion in the OAB-q (seen in this outcome measure) consisted of 25 HRQL items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction), scored 1-6. The total HRQoL score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.|Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
2618232|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score|The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion in the OAB-q (seen in this outcome measure) consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.|Baseline and weeks 4, 8 and 12|FAS participants with available data at each time point were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2618233|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)|The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.|Baseline and weeks 4, 8, 12, EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT .|||units on a scale||Standard Error|Least Squares Mean
2618234|NCT01972841|Secondary|Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT|The number of incontinence-free days with < 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||days||Standard Error|Mean
2618235|NCT01972841|Secondary|Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT|The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with less than 8 micturitions per day.|Weeks 4, 8,12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||days||Standard Error|Mean
2618236|NCT01972841|Secondary|Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT|The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||incontinence-free days||Standard Error|Mean
2618237|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours|The mean number of pads used per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.|Baseline and weeks 4, 8 and 12 (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 pad used at baseline were included in the analysis.|||pads||Standard Error|Least Squares Mean
2618238|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used||Baseline and weeks 4, 8, 12 and EOT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 pad used at baseline were included in the analysis.|||pads||Standard Error|Least Squares Mean
2618239|NCT01972841|Secondary|Number of Pads Used at Weeks 4, 8, 12 and EoT|The number of pads used was the number of times a participant recorded a new pad used on valid diary days during the 7-day micturition diary period prior to each visit.|Weeks 4, 8 and 12 (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 pad used at baseline were included in the analysis.|||pads||Standard Error|Mean
2618240|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours|The mean number of nocturia episodes per 24hr was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.|Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis.|||nocturia episodes||Standard Error|Least Squares Mean
2618241|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes||Baseline and weeks 4, 8, 12, and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis.|||nocturia episodes||Standard Error|Least Squares Mean
2618242|NCT01972841|Secondary|Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT|A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant went to bed with the intention to sleep until the time the patients got up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode on valid diary days during the 7-day micturition diary period prior to each visit.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis.|||nocturia episodes||Standard Error|Mean
2618243|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours|An urgency episode was a complaint of a sudden, compelling desire to pass urine, which was difficult to defer; it was recorded when a micturition or incontinence episode was recorded and the severity of urinary urgency recorded was 3 (severe urgency) or 4 (urgency incontinence) according to the Patient Perception of Intensity of Urgency Scale (PPIUS). The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.|Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 urgency episode at baseline were included in the analysis.|||urgency episodes||Standard Error|Least Squares Mean
2618244|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours|The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.|Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||urgency incontinence episodes||Standard Error|Least Squares Mean
2618245|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes||Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis. LOCF was used for EoT.|||urgency incontinence episodes||Standard Error|Least Squares Mean
2618246|NCT01972841|Secondary|Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT|An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the number of times a participant recorded an urgency incontinence episode on valid diary days during the 7-day micturition diary period prior to each visit.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis.|||urgency incontinence episodes||Standard Error|Mean
2618247|NCT01972841|Secondary|Change From Baseline to EoT in Corrected Micturition Frequency|Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline.|Baseline and Week 12|FAS. LOCF was used for EoT.|||micturitions||Standard Error|Least Squares Mean
2618248|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition||Baseline and weeks 4, 8 and 12|FAS participants with available data at each time point were included in the analysis.|||mL||Standard Error|Least Squares Mean
2618249|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours||Baseline and weeks 4, 8 and 12|FAS participants with available data at each time point data were included in the analysis.|||micturitions||Standard Error|Least Squares Mean
2618250|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours||Baseline and weeks 4, 8 and 12|FAS participants with available data at each time point were included in the analysis.|||incontinence episodes||Standard Error|Least Squares Mean
2618251|NCT01972841|Secondary|Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes||Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||incontinence episodes||Standard Error|Least Squares Mean
2618252|NCT01972841|Secondary|Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT|The number of incontinence episodes was calculated as the total number of incontinence episodes on valid diary days recorded during the 7-day micturition diary period.|Weeks 4, 8, 12 and EoT (up to 12 weeks)|FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.|||incontinence episodes||Standard Error|Mean
2618253|NCT01972841|Secondary|Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)|The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.|Baseline and EoT (up to 12 weeks)|FAS. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
2618254|NCT01972841|Secondary|Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score|The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement.|Baseline and EoT (up to 12 weeks)|FAS. LOCF was used for EoT.|||units on a scale||Standard Error|Least Squares Mean
2618255|NCT01972841|Secondary|Change From Baseline to EoT in Mean Volume Voided Per Micturition|The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period.|Baseline and EoT (up to 12 weeks)|FAS. LOCF was used for EoT.|||mL||Standard Error|Least Squares Mean
2618315|NCT01972516|Secondary|Overall Survival (OS) Evaluation|To evaluate the overall survival with and without maintenance therapy with Tivozanib in patients who have achieved a complete response following therapy for platinum sensitive disease.|2 Years|Outcome measure not analyzed due to low accrual and subsequent termination of the study.||||||
2618256|NCT01972841|Primary|Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours|A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.|Baseline and EoT (up to 12 weeks)|FAS. LOCF was used for EoT.|||micturitions||Standard Error|Least Squares Mean
2618257|NCT01972841|Primary|Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.|Baseline and EoT (up to 12 weeks)|FAS comprised all RAS patients who took ≥ 1 dose of double-blind treatment after randomization, reported ≥ 1 micturition in the baseline diary and ≥ 1 micturition postbaseline, reported ≥ 1 incontinence episode in the baseline diary and excluded participants from one site. Last observation carried forward (LOCF) was used for EoT.|||incontinence episodes||Standard Error|Least Squares Mean
2618258|NCT01972789|Secondary|The Number of Times a Participant Needs to Return to Monthly Treatments During the 24 Months.|Treatment requirements will be determined by the individual patient disease activity as measured by OCT, BCVA, colour fundus photography and fluorescein angiography (FA). Analysis was not performed.|Month 24|Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint.|||Visits||Standard Deviation|Mean
2618259|NCT01972789|Secondary|Proportion of Patients With Both SRF (Sub-retinal Fluid) and IRF (Intra-retinal Fluid) Who Despite Monthly Treatment do Not Resolve Their SRF|Assessed by Optical Coherence Tomography (OCT) and confirmed by a central reading centre.|Month 12 and 24|Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint|||Participants|||Number
2618260|NCT01972789|Secondary|Number of Participants With the Genotypes Associated With Age-Related Macular Degeneration (AMD) and Response to Treatment at Baseline; Correlation With Visual Acuity (VA) Outcome and Ability to Dry the Retina.|DNA will be extracted from saliva and genotyping performed on the significantly associated single nucleotide polymorphisms (SNPs) identified by the AMD Gene Consortium (Nature Genetics, March 2013). Genotypes will be derived through the use of a Sequenom Iplex protocol. No correlation analyses were performed.|Baseline or following consent|Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint|||Participants|||Number
2618261|NCT01972789|Secondary|Proportion of Patients Showing Less Than 15 Letters ETDRS Loss From Baseline to Month 12 and 24.|Best-corrected visual acuity with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and months 2, 12 and 24.|Baseline to months 12 and 24|Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint|||Participants|||Number
2618262|NCT01972789|Secondary|Proportion of Patients Showing Greater Than or Equal to 15 Letters Early Treatment Diabetic Retinopathy (ETDRS) Gain From Baseline to Month 12 and 24.|Best-corrected visual acuity (BCVA) with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and months 2, 12 and 24.|Baseline to months 12 and 24.|Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint|||Participants|||Number
2618263|NCT01972789|Secondary|Proportion of Patients Showing no IRF and SRF at Months 2, 12 and 24.|Assessed by Optical Coherence Tomography (OCT) and confirmed by a central reading centre.|Months 2, 12 and 24.|Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint|||Participants|||Number
2618264|NCT01972789|Secondary|Proportion of Patients Showing Newly Developed Geographic Atrophy (GA) at Months 12 and 24|A multimodal imaging approach will be used to assess the presence of new geographic atrophy (defined as incorporating both geographic atrophy and atrophy associated with the CNV) in the study eye at baseline, and month 12 and 24. Image modalities will include fundus autofluorescence (AF) imaging, infrared imaging, OCT and colour fundus (CF) photographs. Atrophy will be diagnosed if FA and one other modality confirm the presence of macular atrophy|Months 12 and 24|Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomized and whom have at least one post-Baseline efficacy value for the primary endpoint|||Participants|||Number
2618265|NCT01972789|Secondary|Mean Change in Area of New and Existing Geographic Atrophy From Baseline to Month 12 and 24.|Autofluorescence will be measured by multimodal imaging to assess the presence and development of geographic atrophy in the study at baseline, and month 12 and 24.|Baseline to months 12 and 24.|Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint|||mm^2||Standard Deviation|Mean
2618266|NCT01972789|Secondary|Mean Number of Injections From Baseline to Month 12 and 24|The number of injections will be determined by the individual patient response to ranibizumab therapy and potential for extension between injections based on specific criteria: loss of visual acuity, new retinal haemorrhage, and presence of IRF or SRF on OCT.|Baseline to month 12 to month 24.|Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint|||Injections||Standard Deviation|Mean
2618267|NCT01972789|Secondary|Mean Change in Central Retinal Thickness (CRT) From Baseline to Month 12 and 24.|Central retinal thickness will be measured by Optical Coherence Tomography (OCT) at every visit.|Baseline to month 12 and month 24|Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint|||μm||Standard Deviation|Mean
2618268|NCT01972789|Secondary|Mean Change in BCVA From Baseline to Month 12.|Best-corrected visual acuity (BCVA) with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and month 12.|Baseline to month 12|Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint|||Letters||Standard Deviation|Mean
2618269|NCT01972789|Primary|Mean Change in Best-corrected Visual Acuity (BCVA) From Baseline to 24 Months.|Best-corrected visual acuity (BCVA) with refraction will be taken using a logMAR chart at a distance of 3 metres in the study eye at baseline and month 24.|Baseline to month 24|Full Analysis Set (FAS): The Full Analysis Set (FAS) compromises all subjects randomised and whom have at least one post-Baseline efficacy value for the primary endpoint|||Letters||Standard Deviation|Mean
2618270|NCT01972776|Secondary|Change From Baseline in Scond/Sacin as Measured by Multiple Breath Nitrogen Washout (MBNW) (Part 2)||baseline, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
2618271|NCT01972776|Secondary|Change From Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLco) (Part 2)||baseline, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
2618272|NCT01972776|Secondary|Change From Baseline in Percentage Sputum Neutrophils (Part 2)||baseline, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
2618273|NCT01972776|Secondary|Tmax Between 0h and 24h (Part 2)||day 1, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
2618274|NCT01972776|Secondary|Cmax Between 0h and 24h (Part 2)||day 1, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
2618275|NCT01972776|Secondary|AUC0-24 (Part 2)||day 1, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
2618276|NCT01972776|Secondary|Change From Baseline in Forced Expirtory Flow 25-75 (FEF25-75), Forced Expiratory Volume 3 (FEV3)/Forced Vital Capacity (FVC), 1-(FEV3/FVC), FEV6, FEV1/FEV6 and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (Part 2)||baseline, day 56|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
2618277|NCT01972776|Secondary|Change From Baseline in Lung Clearance Index 2.5 (LCI2.5) (Part 1)|Lung clearance index (LCI) is a measure of abnormal ventilation distribution derived from the multiple breath inert gas washout (MBW) technique. LCI is equal to the cumulative expired volume/functional residual capacity. LCI was measured at baseline and day 14. LCI was analyzed using a Bayesian model for repeated measurements. The model may investigate effects for pre-dose baseline, treatment, time, age, COPD class, treatment by time interaction, and baseline by time interaction. A positive change from baseline indicates improvement.|baseline, day 14 pre-dose|All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.|||index score||Standard Error|Mean
2618278|NCT01972776|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) (Part 1)|FEV1 is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry and performed at approximately the same time of day on each visit to avoid diurnal variation. All spirometry calibrations and evaluations followed the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. A positive change from baseline in FEV1 indicates improvement in lung function.|baseline, day 14 pre-dose|All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.|||mL||Standard Error|Mean
2618279|NCT01972776|Secondary|Change From Baseline in Chemokine (C-X-C Motif) Receptor 2 (CXCR2) Receptor Occupancy (Part 1)|Whole blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein in order to measure CXCR2 receptor occupancy on neutrophils. A positive change from baseline indicates improvement.|baseline, day 14|All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.|||percent change|||Number
2618280|NCT01972776|Secondary|Change From Baseline in Cluster of Differentiation 11b (CD11b) (Part 1)|Whole blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein in order to measure CD11b expression on neutrophils. A negative change from baseline indicates improvement.|baseline, day 14|All Randomized Part 1 participants were considered for the analysis but participants with both baseline and day 14 values were analyzed.|||percentage change|||Number
2618281|NCT01972776|Secondary|Tmax,ss (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 14 (from pre-dose to 72 hours post dose)|All Part 1 participants who received active treatment.|||hours||Full Range|Median
2618282|NCT01972776|Secondary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 1 (from pre-dose to 12 hours post dose)|All Part 1 participants who received active treatment.|||hours||Full Range|Median
2618283|NCT01972776|Secondary|Cmax,ss (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 14 (from pre-dose to 72 hours post dose)|All Part 1 participants who received active treatment.|||ng/mL||Standard Deviation|Mean
2618284|NCT01972776|Secondary|Observed Maximum Plasma Concentration Following Drug Administration (Cmax) (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 1 (from pre-dose to 12 hours post dose)|All Part 1 participants who received active treatment.|||ng/mL||Standard Deviation|Mean
2618285|NCT01972776|Secondary|AUCtau, Steady State (AUCtau,ss) (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 14 (from pre-dose to 72 hours post dose)|All Part 1 participants who received active treatment.|||ng*h/mL||Standard Deviation|Mean
2618286|NCT01972776|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval, Tau (AUCtau) (Part 1)|Venous blood samples were collected for concentration-time profiles.|day 1 (from pre-dose to 12 hours post dose)|All Part 1 participants who received active treatment.|||ng*h/mL||Standard Deviation|Mean
2618287|NCT01972776|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) (Part 2)||Baseline, 8 weeks|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
2618288|NCT01972776|Primary|Change From Baseline in Transition Dyspnea Index (TDI) (Part 2)||Baseline, 8 weeks|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
2618289|NCT01972776|Primary|Change From Baseline in Absolute Number of Sputum Neutrophils (Part 2)||Baseline, 8 weeks|Part 2 was terminated early. Therefore, primary and secondary outcomes for part 2 were not assessed.||||||
2618292|NCT01972724|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 24|The change between the value of fasting serum glucose collected at Week 24 and fasting serum glucose collected at baseline. A negative change from baseline indicates improvement.|Baseline and Week 24|Intent-to-treat population was defined as all participants who took at least 1 dose of the study drug.|||mmol/L||Standard Deviation|Mean
2618293|NCT01972724|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|The change from baseline in glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Week 24. A negative change from baseline indicates improvement.|Baseline and Week 24|Intent-to-treat population was defined as all participants who took at least 1 dose of the study drug. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2618294|NCT01972659|Secondary|Postoperative Morphine Consumption||after 12 hour surgery|||||||
2618295|NCT01972659|Secondary|Rocuronium Supplementation||during surgery|||||||
2618296|NCT01972659|Secondary|Rocuronium Onset Time||during the surgery|||||||
2618297|NCT01972659|Primary|TOF 0.9 Achieving Time||end of the surgery||||minutes||Standard Deviation|Mean
2618298|NCT01972568|Primary|Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Day 1 as Baseline|SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score.|Week 24|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.|||percentage of subjects|||Number
2618299|NCT01972568|Post-Hoc|High Disease Activity Subpopulation (SLEDAI-2K >=10 at Screening): Logistic Regression of Percentage of Subjects With SRI-6 Response at Week 24|SRI-6 response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 6 points; no significant worsening in Physician's Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score. Logistic regression of number of subjects with SRI-6 response was analyzed by using Logistic regression model.|Week 24|mITT_HDA analysis set included mITT population with high disease activity (HDA) defined as screening SLE Disease Activity Index (SLEDAI) >=10.|||percentage of subjects|||Number
2618300|NCT01972568|Secondary|Change From Week 0 (Day 1) in SF-36 Components at Week 24|The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component summary scores. Total of 10 variables were analyzed (8 aspects, 2 component summary scores). The score for each of the 8 aspects and 2 component summary scores was scaled from 0 to 100, where 0 = lowest level of functioning and 100 = highest level of functioning.|Week 0 (Day 1) and Week 24|"mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. Here Number Analyzed signifies those subjects who were evaluable for this outcome measure at specified categories."|||units on a scale||Standard Deviation|Mean
2618301|NCT01972568|Secondary|Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs|An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 48 weeks. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline up to 24 weeks after last dose of study drug (assessed up to maximum of 48 weeks)|Safety analysis set included all randomized subjects who received at least 1 dose of IMP.|||percentage of subjects|||Number
2618302|NCT01972568|Secondary|Percentage of Subjects With British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA) Response at Week 24|The BICLA response is defined as BILAG-2004 improvement (all screening visit BILAG A improving to B/C/D, all screening visit BILAG B to C/D, and <=1 new BILAG B and no new BILAG A); no deterioration in SLEDAI total score; PGA increase by <10% (defined as <0.3 point increase for the statistical analyses) and no nonpermitted medication/treatment.|Week 24|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||percentage of subjects|||Number
2618303|NCT01972568|Secondary|Time From Randomization to First SRI Response During Treatment Period|SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score. Time to first SRI response during treatment period was presented.|Baseline up to 24 Weeks|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.|||weeks||95% Confidence Interval|Median
2618304|NCT01972568|Secondary|Change From Screening in Prednisolone-Equivalent Corticosteroid (CS) Daily Dose at Week 24|Change From screening visit to Week 24 of prednisolone-equivalent CS daily dose was presented.|Screening and Week 24|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.|||mg per day||Standard Deviation|Mean
2618316|NCT01972516|Secondary|Progression-Free Survival (PFS) Evaluation|To evaluate progression-free survival with no maintenance therapy in patients who have achieved a complete response following therapy for platinum sensitive disease.|2 Years|Outcome measure not analyzed due to low accrual and subsequent termination of the study.||||||
2618305|NCT01972568|Secondary|Percentage of Subjects With Patient Global Impression of Change (PGIC) Categories at Week 24|The PGIC is self-rated scale that asks the subject to describe the change in activity limitations, symptoms, emotions, and overall Quality of life (QoL) related to the subject's painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Percentage of subjects in the PGIC categories of very much or much improved (1 or 2), minimally improved or no change or minimally worse (3 or 4 or 5) and much or very much worse (6 or 7) at Week 24 were presented.|Week 24|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.|||percentage of subjects|||Number
2618306|NCT01972568|Secondary|Percentage of Subjects at Week 24 Whose Prednisone-Equivalent Corticosteroid (CS) Dose Reduced From Screening by >=25% and to a Dose of =<7.5mg/Day, and no British Isles Lupus Assessment Group (BILAG) A or 2B Flare in Disease Activity|BILAG A or 2B flare is defined by 1 new BILAG A organ domain score and/or 2 new BILAG B organ domain scores compared to the Screening Visit. The BILAG disease activity index evaluates systemic lupus erythematosus (SLE) activity in 8 organ systems, using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Disease sufficiently active requiring disease-modifying treatment (prednisone >20 mg daily or immunosuppressants); BILAG B: moderate disease activity requiring treatment with systemic low-dose oral glucocorticoids, intramuscular or intra-articular or soft tissue CS injection, topical CS or immunosuppressants, or symptomatic therapy such as antimalarials or NSAIDs. BILAG C: mild disease; BILAG D: system previously affected but now inactive and BILAG E: system never involved.|Week 24|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP. Here “Number of Participants Analyzed” signifies those subjects whose CS dose >=10 mg at Screening.|||percentage of subjects|||Number
2618307|NCT01972568|Primary|Percentage of Subjects With Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response at Week 24 Using Screening Visit as Baseline|SRI response, a composite measure of reduced SLE disease activity, was defined as a reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) disease activity score of greater than or equal to (>=) 4 points; no significant worsening in Physician's Global Assessment (PGA) score (<10 % increase, defined as <0.3 point increase for statistical analyses); no new British Isles Lupus Assessment Group (BILAG) A organ domain scores and <=1 (defined as no more than one) new BILAG B organ domain score.|Week 24|mITT analysis set included all randomized subjects who had received at least 1 dose of IMP.|||percentage of subjects|||Number
2618308|NCT01972529|Other Pre-specified|Number of Participants Experiencing an Adverse Event|Safety assessments consisted of monitoring and recording all adverse events (AEs) and serious adverse events, including platelet transfusion-related complications; routine laboratory evaluation for hematology, serum chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); the performance of physical examinations; and Doppler sonography. AE severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death related to the AE. All AEs graded as 4 or 5 were considered to be serious. Treatment-emergent adverse events (TEAEs) were defined as an AE that started on or after the date of first dose of study drug, up to 30 days after the last dose of study drug. Treatment-related AEs were considered by the investigator to be possibly or probably related to study drug.|From date of first dose of study drug up to 30 days after the last dose of study drug, up to approximately 3 years|Safety analysis set included all participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||Participants|||Count of Participants
2618309|NCT01972529|Other Pre-specified|Percentage of Participants With a World Health Organization (WHO) Bleeding Score Greater Than or Equal to 2 After a Scheduled Procedure|The severity of bleeding events was assessed by the investigator (or appropriately delegated study site personnel) using the WHO bleeding scale. The WHO bleeding scale is a clinical investigator-assessed five-point scale with Grade 0 = No bleeding, Grade 1 = Petechial bleeding, Grade 2 = Mild blood loss (clinically significant), Grade 3 = Gross blood loss (requires transfusion (severe)), and Grade 4 = Debilitating blood loss, retinal or cerebral associated with fatality. Participants with missing information are considered as having a WHO bleeding score greater than or equal to 2 in the analysis.|Baseline (Visit 2) up to 7 days post scheduled procedure|FAS|||Percentage of participants|||Number
2618310|NCT01972529|Secondary|Change From Baseline in Platelet Count on the Scheduled Procedure Day|Last observation carried forward was used for participants with a missing platelet count on the scheduled procedure day. Platelet count was measured preprocedure and before any platelet transfusion.|Baseline (Visit 2) to Procedure Day 10 to Day 13 (Visit 4)|FAS|||Platelet count x 10^9/per liter||Standard Deviation|Mean
2618311|NCT01972529|Secondary|Percentage of Participants Who Achieved a Platelet Count Greater Than or Equal to 50 x 10^9/L on the Scheduled Procedure Day|Responders were defined as participants who achieved a platelet count greater than or equal to 50 x 10^9/L on the procedure day. Participants with missing a platelet count on the procedure day were conservatively considered as not achieving a platelet count of 50x10^9/L in the analysis, (i.e. Non-responders).|Day 10 to Day 13 (Visit 4)|FAS|||Percentage of participants||95% Confidence Interval|Number
2618312|NCT01972529|Primary|Percentage of Participants Who Did Not Require a Platelet Transfusion or Any Rescue Procedure for Bleeding After Randomization Following a Scheduled Procedure|Responders were defined as participants who did not require a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure. Participants with missing information due to early withdrawal or other reasons were conservatively considered as having received a transfusion in the analysis, (i.e. a Non-responder).|Baseline (Visit 2) up to 7 days following a scheduled procedure|Full analysis Set (FAS) was defined as the group of all randomized participants.|||Percentage of participants||95% Confidence Interval|Number
2618313|NCT01972516|Secondary|Quality of Life (QOL) Evaluation|To evaluate the impact of treatment with Tivozanib versus placebo alone on the Quality of Life (QOL) through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC QLQ-Ovarian Cancer Module (EORTC QLQ-OV28) for functioning and symptoms.|2 Years|Outcome measure not analyzed due to low accrual and subsequent termination of the study.||||||
2618314|NCT01972516|Secondary|Toxicity Rate Comparison|To compare rates of toxicity with and without maintenance therapy with Tivozanib.|2 Years|Outcome measure not analyzed due to low accrual and subsequent termination of the study.||||||
2618317|NCT01972516|Primary|Progression-Free Survival (PFS) Comparison|"To compare progression-free survival of maintenance therapy with Tivozanib against standard of care in patients with ovarian, fallopian tube or primary peritoneal carcinoma who have achieved a complete response following therapy for platinum sensitive disease.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)"|2 Years|Reporting the number of cycles each patient completed. Each cycle = 4 weeks.|||Cycles|||Number
2618318|NCT01972464|Post-Hoc|Questionnaire on Smoking Urges (QSU)-Brief Score|Scale is scored from 10 to 70. Higher scores indicate more severe symptoms|treatment period; baseline through week 8, measured weekly||||units on a scale||Standard Deviation|Mean
2618319|NCT01972464|Post-Hoc|Time to Relapse|The Outcome Measure is reporting the time in weeks to relapse|baseline through 3-month post trial follow-up||||weeks||Inter-Quartile Range|Median
2618320|NCT01972464|Secondary|7-day Point Prevalence of Abstinence at End of Treatment (Week 8)|Abstinence was defined as self-report of no smoking in the past 7 days confirmed by a negative urine cotinine test (urine cotinine <100 ng/ml).|Week 8 of the trial period||||Participants|||Count of Participants
2618321|NCT01972464|Primary|Feasibility of Progesterone as a Relapse Prevention Intervention for Postpartum Women With Pre-conception Smoking: Retention|Feasibility in retention will be shown by at least 70% of women randomized to the progesterone group reamaining in the study at the 3-month follow-up|From randomization to 3-month follow-up: up to 5 months||||Participants|||Count of Participants
2618322|NCT01972464|Primary|Feasibility of Progesterone as a Relapse Prevention Intervention for Postpartum Women With Pre-conception Smoking: Adherence to Treatment|Feasibility will be shown by high adherence to treatment condition assessed by doses of study medication taken|8 weeks|Adherence to treatment as measured by mean (SD) doses of study medication taken by women in each arm of the study.|||doses of medication||Standard Deviation|Mean
2618323|NCT01972438|Secondary|Mean Change in Tear Composition (Tear Osmolarity) in the Fellow Eye at 6 Months Compared to Baseline|The fellow eye is the untreated eye. The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||mOsm/L|eyes|Standard Deviation|Mean
2618324|NCT01972438|Secondary|Mean Change in Tear Composition (Tear Osmolarity) in the Fellow Eye at 3 Months Compared to Baseline|The fellow eye is the untreated eye. The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||mOsm/L|eyes|Standard Deviation|Mean
2618325|NCT01972438|Secondary|Mean Change in Tear Composition (Tear Osmolarity) in the Study Eye at 6 Months Compared to Baseline|The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||mOsm/L|eyes|Standard Deviation|Mean
2618326|NCT01972438|Secondary|Mean Change in Tear Composition (Tear Osmolarity) in the Study Eye at 3 Months Compared to Baseline|The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||mOsm/L|eyes|Standard Deviation|Mean
2618327|NCT01972438|Secondary|Mean Change in Tear Stability (Tear Break-up Time) in the Fellow Eye at 6 Months Compared to Baseline|The fellow eye is the untreated eye. Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||seconds|eyes|Standard Deviation|Mean
2618328|NCT01972438|Secondary|Mean Change in Tear Stability (Tear Break-up Time) in the Study Eye at 6 Months Compared to Baseline|Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||seconds|eyes|Standard Deviation|Mean
2618329|NCT01972438|Secondary|Mean Change in Tear Stability (Tear Break-up Time) in the Fellow Eye at 3 Months Compared to Baseline|The fellow eye is the untreated eye. Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||seconds|eyes|Standard Deviation|Mean
2618330|NCT01972438|Secondary|Mean Change in Tear Stability (Tear Break-up Time) in the Study Eye at 3 Months Compared to Baseline|Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||seconds|eyes|Standard Deviation|Mean
2618377|NCT01972204|Secondary|Reasons for Discontinuation|Reasons for discontinuation of the Medication|48 weeks||||Participants|||Count of Participants
2618378|NCT01972204|Primary|Number of Participants With Medication Continuation|Number of Participants who Continue the Medication for 48 weeks|48 weeks||||participants|||Number
2623140|NCT01932970|Primary|Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL During the 4-week Treatment Period||4 weeks|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2618331|NCT01972438|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Fellow Eye at 6 Months Compared to Baseline.|The fellow eye is the untreated eye. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||ETDRS letters|eyes|Standard Deviation|Mean
2618332|NCT01972438|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 6 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||ETDRS letters|eyes|Standard Deviation|Mean
2618333|NCT01972438|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Fellow Eye at 3 Months Compared to Baseline|The fellow eye is the untreated eye. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||ETDRS letters|eyes|Standard Deviation|Mean
2618334|NCT01972438|Secondary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 3 Months Compared to Baseline.|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||ETDRS letters|eyes|Standard Deviation|Mean
2618335|NCT01972438|Secondary|Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Fellow Eye at 6 Months Compared to Baseline|"The fellow eye is the untreated eye. The CAS score is the sum of the scores on three separate assessments: Schirmer's tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome.~*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9."|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||scores on a scale|eyes|Standard Deviation|Mean
2618336|NCT01972438|Secondary|Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Study Eye at 6 Months Compared to Baseline|"The CAS score is the sum of the scores on three separate assessments: Schirmer's tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome.~*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9."|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||scores on a scale|eyes|Standard Deviation|Mean
2618337|NCT01972438|Secondary|Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Fellow Eye at 3 Months Compared to Baseline|"The fellow eye is the untreated eye. The CAS score is the sum of the scores on three separate assessments: Schirmer's tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome.~*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9."|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||scores on a scale|eyes|Standard Deviation|Mean
2618338|NCT01972438|Secondary|Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Study Eye at 3 Months Compared to Baseline|"The CAS score is the sum of the scores on three separate assessments: Schirmer's tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome.~*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9."|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||scores on a scale|eyes|Standard Deviation|Mean
2618379|NCT01972152|Secondary|Glucagon Tmax|Pharmacokinetic parameter: Time to maximum concentration of glucagon|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.|||minutes||Standard Deviation|Mean
2618339|NCT01972438|Secondary|Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Fellow Eye at 6 Months Compared to Baseline|The fellow eye is the untreated eye. Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||scores on a scale|eyes|Standard Deviation|Mean
2618340|NCT01972438|Secondary|Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Study Eye at 6 Months Compared to Baseline|Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 6 Months|Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.|||scores on a scale|eyes|Standard Deviation|Mean
2618341|NCT01972438|Secondary|Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Fellow Eye at 3 Months Compared to Baseline|The fellow eye is the untreated eye. Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||scores on a scale|eyes|Standard Deviation|Mean
2618342|NCT01972438|Secondary|Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Study Eye at 3 Months Compared to Baseline|Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 3 Months|Twelve participants completed the first crossover treatment period at Month 3.|||scores on a scale|eyes|Standard Deviation|Mean
2618343|NCT01972438|Secondary|Number of Participants Withdrawn From the Study Treatment Due to Vision Loss, Adverse Events or Treatment Failure||Study Duration, up to 24 months||||participants|||Number
2618344|NCT01972438|Secondary|Number of Systemic and Ocular Toxicities and Adverse Events||Study Duration, up to 24 months||||adverse events|||Number
2618345|NCT01972438|Primary|Proportion of Participants Who Experienced a ≥ 50% Reduction in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH/National Eye Institute (NEI) Visual Analogue Scale in the Study Eye From Baseline to Month 3.|A ≥ 50% reduction in the combined score was considered a treatment success. While the design is a crossover study, the primary outcome was assessed after the first period at Month 3. Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.|Baseline and 3 months|This analysis is conducted on the per-protocol population, defined as those who adhered to the protocol prior to drug unavailability, not on the intent-to-treat population due to lack of visit information beyond baseline for 3 participants. Three never started drug: one was unable to donate blood, one was ineligible at screening and one died.|||participants|eyes||Number
2618346|NCT01972308|Secondary|Change in Urgent Office Visit|Records or if not available patient report of an urgent office visit in the 6 months before baseline compared with record or report of urgent office visits in the 6 months prior to one year. An urgent office visit is one scheduled within 24 hours of the visit.|one year||||urgent visits per 6 months||95% Confidence Interval|Least Squares Mean
2618347|NCT01972308|Secondary|Risk of Prednisone Bursts|a new dose or an increase in already prescribed prednisone dose|baseline and one year||||risk of prednisone bursts||95% Confidence Interval|Least Squares Mean
2618348|NCT01972308|Secondary|Change in Hospitalizations|Participants will report hospitalizations verified if possible in participating health systems. We review records and if not available ask patient for hospititalizations over the 6 months before baseline and compare it with the record or report in the 6-months prior to one year.|one year||||hospitalizations per 6 months||95% Confidence Interval|Least Squares Mean
2618349|NCT01972308|Secondary|Change in Asthma-related Quality of Life|Asthma-related quality of life will be measured with the Mini-Asthma Quality of Life Questionnaire (AQLQ). This 15-item questionnaire with each item having a 7-point response scale that provides a mean summary score. A 0.5-unit change is considered clinically meaningful. the range is 1 - 7 with higher score better quality of life.|baseline to one year||||units on a scale||95% Confidence Interval|Least Squares Mean
2618350|NCT01972308|Secondary|Change in Emergency Department(ED) Visits at One Year|Emergency room visits in the 6 months before entry compared with emergency room visits in the 6 months prior to the one year timepoint|one year||||visits per 6 months||95% Confidence Interval|Least Squares Mean
2618380|NCT01972152|Secondary|Glucagon Cmax|Pharmacokinetic parameter: Maximum concentration of glucagon|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.|||pg/ml||Standard Deviation|Mean
2618351|NCT01972308|Primary|Change in Asthma Control at One Year|"Asthma Control Questionnaire: In a randomized controlled trial we will assess whether 6 months of the Patient Advocate Intervention improves asthma control relative to baseline compared with usual care (UC) and whether such a difference is sustained in the 6 months following the intervention's completion.~Asthma Control range is 0-6 with lower score better control (0= total control and 6 = extremetly uncontrolled. The minimally important clinical difference is 0.5. A score > 1.5 is considered inadequate control."|baseline and 1 year|18 years or more, physician’s diagnosis of asthma, prescribed an inhaled-steroid for asthma, moderate or severe persistent asthma, evidence of reversible airflow obstruction, at least one appointment scheduled with the asthma physician during the 1st 6 months of participation|||units on a scale||95% Confidence Interval|Least Squares Mean
2618352|NCT01972282|Primary|Death|All cause mortality|2 year follow-up|Patients who undergo WATCHMAN implant in a commercial clinical setting.|||Participants|||Count of Participants
2618353|NCT01972282|Primary|Ischemic Stroke|occurence of Ischemic stroke during the 2 years of FU. Expressed as nr events / 100 patient-years of FU|2 year follow-up|Patients who undergo WATCHMAN implant procedure in a commercial clinical setting|||Nr events/100 Patient-years||95% Confidence Interval|Number
2618354|NCT01972282|Primary|Procedural Complications|All device/procedure related Serious Adverse Events (with or without Major intervention)|7 days post-implant||||percentage of participants|||Number
2618355|NCT01972217|Secondary|Part B: Median Time to Second Progression or Death (PFS2)|The efficacy of olaparib when given in combination with abiraterone was assessed by PFS2, defined by local standard clinical practice and included objective radiological progression by RECIST 1.1 (soft tissue), symptomatic progression, rise in PSA level or death in the absence of overall progression.|From randomisation until analysis cut-off date (up to approximately 3 years).|The Full analysis set consisted of all randomised patients in Part B, regardless of treatment actually received.|||Months||95% Confidence Interval|Median
2618356|NCT01972217|Secondary|Part B: Median Overall Survival (OS)|"OS was determined to assess the efficacy of olaparib when given in addition to abiraterone, compared with placebo given in addition to abiraterone.~OS was performed at the time of the analysis of rPFS, and the median OS, calculated using the Kaplan-Meier technique, is presented."|From baseline, every 12 weeks up to Week 72, then every 24 weeks up to 24 months.|The Full analysis set consisted of all randomised patients in Part B, regardless of treatment actually received.|||Months||95% Confidence Interval|Median
2618357|NCT01972217|Secondary|Median Time to First Subsequent Therapy (TFST) and Median Time to Second Subsequent Therapy (TSST)|"The TFST and TSST were determined to assess the anti-tumour activity of olaparib when given in combination with abiraterone, compared with placebo given in addition to abiraterone.~TFST was defined as the time from randomisation to the earlier of first subsequent anti-cancer therapy start date following study treatment discontinuation, or death.~TSST was defined as the time from randomisation to the earlier of the second subsequent anti-cancer therapy start date following study treatment discontinuation, or death."|From randomisation until analysis cut-off date (up to approximately 3 years).|The Full analysis set consisted of all randomised patients in Part B, regardless of treatment actually received.|||Months||95% Confidence Interval|Median
2618358|NCT01972217|Secondary|Part B: Percentage of Patients With at Least One Objective Response (Objective Response Rate [ORR])|"The overall radiological ORR was calculated to assess the anti-tumour activity of olaparib in combination with abiraterone, compared with placebo in combination with abiraterone.~The best overall ORR was defined as the percentage of patients with at least 1 visit response of complete response (CR) or partial response (PR) in soft tissue disease assessed by RECIST 1.1 and also bone scan status of non-progressive disease or non-evaluable for their bone scans assessed by PCWG-2.~CR: Disappearance of all target lesions. Reduction of pathological lymph nodes to <10 millimetres.~PR: At least a 30% decrease in the sum of diameters of target lesions from baseline.~The percentage of patients with a response is presented."|From baseline, then every 4 weeks up to Week 52, and then every 12 weeks.|The Full analysis set consisted of all randomised patients in Part B, regardless of treatment actually received. Only patients with data available for analysis are presented. Only patients with measurable disease at baseline are included.|||Percentage of patients|||Number
2618359|NCT01972217|Secondary|Part B: Median Best Percentage Change From Baseline in Circulating Tumour Cell (CTC) Level|"The median best percentage change from baseline in CTC levels was determined to assess the anti-tumour activity of olaparib when given in combination with abiraterone, compared with placebo given in addition to abiraterone.~The best percentage change was defined as the biggest CTC level reduction compared with baseline or smallest increase in the absence of a decrease."|From baseline, then every 4 weeks up to Week 24, and then every 12 weeks.|The Full analysis set consisted of all randomised patients in Part B, regardless of treatment actually received. Only patients with data available for analysis are presented.|||Percentage change in CTC level||Full Range|Median
2618360|NCT01972217|Secondary|Part B: Percentage of Patients With PSA Responses|"The percentages of patients with single visit responses and with confirmed responses are presented to assess the anti-tumour activity of olaparib when given in addition to abiraterone, compared with placebo given in addition to abiraterone.~A single visit response was defined as any post-dose visit PSA level reduced by 50% or more compared with baseline.~A confirmed response was defined as a reduction in PSA level of 50% or more on 2 consecutive occasions at least 4 weeks apart compared with baseline.~Patients may have had more than 1 single visit response or confirmed response but were counted once."|From baseline, then every 4 weeks up to Week 24, and then every 12 weeks.|The Full analysis set consisted of all randomised patients in Part B, regardless of treatment actually received.|||Percentage of patients||80% Confidence Interval|Number
2618361|NCT01972217|Secondary|Part B: Median Best Percentage Change From Baseline in Prostate Specific Antigen (PSA) Levels|"The best percentage change from baseline in PSA levels was determined to assess the anti-tumour activity of olaparib when given in addition to abiraterone, compared with placebo given in addition to abiraterone.~The best percentage change was defined as the biggest reduction in PSA level compared with baseline or smallest increase in the absence of a decrease."|From baseline, then every 4 weeks up to Week 52, and then every 12 weeks.|The Full analysis set consisted of all randomised patients in Part B, regardless of treatment actually received. Only patients with data available for analysis are presented.|||Percentage change in PSA level||Full Range|Median
2618395|NCT01971723|Primary|Sex-hormone Binding Globulin Outcomes||Baseline, 2-week mark, 4-week mark||||nmol/l||Standard Deviation|Mean
2618362|NCT01972217|Secondary|Part B: Percentage of Patients Experiencing AEs|"The safety and tolerability of olaparib when given in combination with abiraterone was assessed during Part B of the study. The percentage of patients experiencing AEs, including information on seriousness, severity, study treatment relationship and those leading to discontinuation for all doses of olaparib and for abiraterone are presented.~Severity of AEs was assessed using the NCI Common Terminology CTCAE v4.0. AEs were assigned to a Grade from 1 through 5 as follows:~Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening requiring hospitalisation; Grade 4: Life-threatening consequences; Grade 5: Death related to AE.~'c-r' = causally related. 'discont' = discontinuation. 'ola/pla' = olaparib/placebo."|From first dose of study treatment following randomisation in Part B up to 30 days following last dose of study treatment (up to approximately 3 years).|Part B safety analysis set consisted of all patients randomised into Part B of the study who received at least 1 dose of olaparib/placebo.|||Percentage of patients|||Number
2618363|NCT01972217|Secondary|Part A PK: Abiraterone AUCss|"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone AUCss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented."|PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.|The PK analysis set consisted of all patients who received at least 1 dose of olaparib per the protocol, for whom there was at least 1 reportable PK concentration and who had no important protocol deviations or AEs that impacted on PK on all PK sampling days. Only patients with data available for analysis at each time point are presented.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2618364|NCT01972217|Secondary|Part A PK Analysis: Olaparib Area Under the Plasma Concentration-Time Curve at Steady State (AUCss)|"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib AUCss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented."|PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.|The PK analysis set consisted of all patients who received at least 1 dose of olaparib per the protocol, for whom there was at least 1 reportable PK concentration and who had no important protocol deviations or AEs that impacted on PK on all PK sampling days. Only patients with data available for analysis at each time point are presented.|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2618365|NCT01972217|Secondary|Part A PK: Abiraterone Cmin,ss|"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone Cmin,ss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented."|PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.|The PK analysis set consisted of all patients who received at least 1 dose of olaparib per the protocol, for whom there was at least 1 reportable PK concentration and who had no important protocol deviations or AEs that impacted on PK on all PK sampling days. Only patients with data available for analysis at each time point are presented.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2618366|NCT01972217|Secondary|Part A PK Analysis: Olaparib Minimum Plasma Concentration at Steady State (Cmin,ss)|"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib Cmin,ss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented."|PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.|The PK analysis set consisted of all patients who received at least 1 dose of olaparib per the protocol, for whom there was at least 1 reportable PK concentration and who had no important protocol deviations or AEs that impacted on PK on all PK sampling days. Only patients with data available for analysis at each time point are presented.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2618367|NCT01972217|Secondary|Part A PK: Abiraterone Tmax,ss|"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone tmax,ss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented."|PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.|The PK analysis set consisted of all patients who received at least 1 dose of olaparib per the protocol, for whom there was at least 1 reportable PK concentration and who had no important protocol deviations or AEs that impacted on PK on all PK sampling days. Only patients with data available for analysis at each time point are presented.|||Hours||Full Range|Median
2618368|NCT01972217|Secondary|Part A PK Analysis: Olaparib Time to Reach Maximum Plasma Concentration at Steady State (Tmax,ss)|"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib tmax,ss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented."|PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.|The PK analysis set consisted of all patients who received at least 1 dose of olaparib per the protocol, for whom there was at least 1 reportable PK concentration and who had no important protocol deviations or AEs that impacted on PK on all PK sampling days. Only patients with data available for analysis at each time point are presented.|||Hours (h)||Full Range|Median
2618396|NCT01971723|Primary|Cortisol Outcomes||Baseline, 2-week mark, 4-week mark||||ug/dl||Standard Deviation|Mean
2618397|NCT01971723|Secondary|Volume Performance Outcomes|During the four weeks, the volume ((weight x reps)set 1+(weight x reps)set 2+ (weight x reps)set 3….. ) will be calculated and measured for each exercise in each lifting session.|4 Weeks||||Repetitions||Standard Deviation|Mean
2618369|NCT01972217|Secondary|Part A PK: Abiraterone Cmax,ss|"Following multiple dosing to steady state of abiraterone 1000 mg once daily, the Cohort 2 abiraterone Cmax,ss is presented for abiraterone monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented."|PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.|The PK analysis set consisted of all patients who received at least 1 dose of olaparib per the protocol, for whom there was at least 1 reportable PK concentration and who had no important protocol deviations or AEs that impacted on PK on all PK sampling days. Only patients with data available for analysis at each time point are presented.|||nanograms per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2618370|NCT01972217|Secondary|Part A Pharmacokinetics (PK): Olaparib Maximum Plasma Concentration at Steady State (Cmax,ss)|"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib Cmax,ss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented."|PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.|The PK analysis set consisted of all patients who received at least 1 dose of olaparib per the protocol, for whom there was at least 1 reportable PK concentration and who had no important protocol deviations or AEs that impacted on PK on all PK sampling days. Only patients with data available for analysis at each time point are presented.|||micrograms per millilitre (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2618371|NCT01972217|Primary|Part B: Percentage of Patients With Progression Events or Death (rPFS)|"The efficacy of olaparib when given in combination with abiraterone was assessed by rPFS, defined as the time from randomisation to disease progression using RECIST version 1.1 (for soft tissue disease) and PCWG-2 (for bone disease) criteria, or death.~Progression using RECIST 1.1 criteria was defined as at least 20% increase from baseline in the sum of diameters of target lesions, progression of existing non-target lesions, or the appearance of at least 1 new lesion.~Progression using PCWG-2 criteria was determined if 2 or more new metastatic bone lesions were observed (with a total of at least 4 new lesions since baseline assessment if observed at the 12 week scan, or persistence of or increase in number of lesions if observed after the 12 week scan as determined by a confirmatory scan at least 6 weeks later or at next scheduled visit).~The percentage of patients with progression events is presented overall and according to RECIST 1.1 and/or PCWG-2 criteria, or death."|From baseline, every 12 weeks up to Week 72, then every 24 weeks up to 24 months.|The Full analysis set consisted of all randomised patients in Part B, regardless of treatment actually received.|||Percentage of patients|||Number
2618372|NCT01972217|Primary|Part B: Median Radiological Progression-Free Survival (rPFS) Time|"The efficacy of olaparib when given in combination with abiraterone was assessed by rPFS, defined as the time from randomisation to disease progression using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 (for soft tissue disease) and Prostate Cancer Working Group 2 (PCWG-2) (for bone disease) criteria, or death.~Progression using RECIST 1.1 criteria was defined as at least 20% increase from baseline in the sum of diameters of target lesions, progression of existing non-target lesions, or the appearance of at least 1 new lesion.~Progression using PCWG-2 criteria was determined if 2 or more new metastatic bone lesions were observed (with a total of at least 4 new lesions since baseline assessment if observed at the 12 week scan, or persistence of or increase in number of lesions if observed after the 12 week scan as determined by a confirmatory scan at least 6 weeks later or at next scheduled visit)."|From baseline, every 12 weeks up to Week 72, then every 24 weeks up to 24 months.|The Full analysis set consisted of all randomised patients in Part B, regardless of treatment actually received.|||Months||95% Confidence Interval|Median
2618373|NCT01972217|Primary|Part A: Number of Patients With Dose Limiting Toxicities (DLTs)|"DLTs were assessed by a Safety Review Committee (SRC) after a minimum of 3 patients had received at least 14 days of treatment in Part A.~A DLT was defined as any toxicity which was not a recognised AE of abiraterone or prednisolone, and was not attributable to the disease or disease-related processes under investigation, which occurred during a minimum period of 14 days treatment and which included: 1. haematological toxicity CTCAE v4.0 Grade 4 or higher present for more than 4 days (except anaemia); 2. non-haematological toxicity CTCAE v4.0 Grade 3 or higher including infection, corrected QT interval prolongation; 3. any other toxicity that was greater than that at baseline, was clinically significant and/or unacceptable, did not respond to supportive care, resulted in a disruption of dosing schedule of 7 days or more, or was judged to be a DLT by the SRC.~A DLT excluded alopecia and isolated laboratory changes of any grade without clinical sequelae or clinical significance."|From Day 1 for Cohort 1 and from Day 4 for Cohort 2 up to 14 days treatment with olaparib + abiraterone for 3 patients.|The Part A Safety analysis set consisted of all patients who received at least 1 dose of study treatment in Part A. Treatment group comparisons were based on the initial dose of olaparib actually received.|||Patients|||Number
2618374|NCT01972217|Primary|Part A: Percentage of Patients Experiencing Adverse Events (AEs)|"The safety and tolerability of olaparib in combination with abiraterone was assessed during Part A of the study. The percentage of patients experiencing AEs, including information on seriousness, severity, study treatment relationship and those leading to discontinuation for all doses of olaparib and for abiraterone are presented.~Severity of AEs was assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse events (CTCAE) v4.0. AEs were assigned to a Grade from 1 through 5 as follows:~Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life-threatening requiring hospitalisation; Grade 4: Life-threatening consequences; Grade 5: Death related to AE.~'c-r' = causally related 'discont' = discontinuation."|Cohort 1 and 2: From baseline in Part A (Day 1 for each cohort) up to 30 days following last dose of study treatment.|The Part A Safety analysis set consisted of all patients who received at least 1 dose of study treatment in Part A. Treatment group comparisons were based on the initial dose of olaparib actually received.|||Percentage of patients|||Number
2618375|NCT01972204|Secondary|Adverse Events|Adverse Events for each arm|Week 2, 12, 24, 48||||participants|||Number
2618376|NCT01972204|Secondary|Number of Participants With Medication Discontinuation Due to Change to Alicept or Generics|Number of Participants who descontinue the Clinical Trial Medication due to Change to Alicept (not for clinical trial) or Generics|48 weeks||||participants|||Number
2618381|NCT01972152|Secondary|Glucagon AUC|Pharmacokinetic parameter: Glucagon area under the curve from baseline to 240 minutes post-treatment|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.|||min*pg/ml||Standard Deviation|Mean
2618382|NCT01972152|Secondary|Glucose Tex|Pharmacodynamic parameter: Earliest reported time of MAE, based on within-subject changes from baseline|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.|||minutes||Standard Deviation|Mean
2618383|NCT01972152|Secondary|Glucose MAE|Pharmacodynamic parameter: Maximum absolute glucose excursion from baseline|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.|||mg/dL||Standard Deviation|Mean
2618384|NCT01972152|Secondary|Glucose AUCex|Pharmacodynamic parameter: Area Under the Glucose Excursion Curve|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.|||min*mg/dL||Standard Deviation|Mean
2618385|NCT01972152|Secondary|Glucose Tmax|Pharmacodynamic parameter: Time to Maximum Glucose Concentration|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.|||minutes||Standard Deviation|Mean
2618386|NCT01972152|Secondary|Glucose Cmax|Pharmacodynamic parameter: Maximum concentration of glucose|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.|||mg/dL||Standard Deviation|Mean
2618387|NCT01972152|Secondary|Glucose Area Under the Curve (AUC)|Pharmacodynamic parameter: Glucose area under the curve from baseline to 240 minutes post-treatment|Approximately 15 minutes before each injection and at 5, 10, 15, 20, 30, 45, 60, 120 and 240 minutes post-injection|Per protocol analysis set. Two subjects were excluded from all analyses: one who completed no treatment visits and had no evaluable data and another who violated eligibility criteria. A third subject was excluded from analysis for the one treatment visit at which the subject's blood samples were inadvertently diluted with saline during collection.|||min*mg/dL||Standard Deviation|Mean
2618388|NCT01972152|Primary|Serious Adverse Events|Number of serious adverse events (SAEs) per treatment group|From first dose until completion of the post-treatment follow-up visit, up to 6 weeks|All subjects receiving treatment were included in this analysis.|||events|||Number
2618389|NCT01972074|Primary|Treatment Responder|Treatment responders are defined as having a 25% reduction, from baseline to endpoint, in Social Responsiveness Scale, Second Edition: School-Age, Parent Report (SRS-2) total raw score and an Autism Spectrum Disorder Clinical Global Impression-Improvement (ASD CGI-I) score ≤2. The Social Responsiveness Scale, Second Edition (SRS-2) is a 65-item rating scale completed by the parents/guardians of children ages 4-18. It is used to measure the severity of autism spectrum disorder symptoms. Each item is rated on a 4-point Likert scale, ranging from 1=Not True to 4=Almost Always True. Higher scores indicate a higher severity of autism spectrum disorder symptoms. The Autism Spectrum Disorder Clinical Global Impression-Improvement subscale (ASD CGI-I) is a clinician-rated measure of the improvement of autism spectrum disorder symptoms. The subscale is rated on a 7-point Likert scale, ranging from 1=Very Much Improved to 7=Very Much Worse. Higher scores indicate less symptom improvement.|12 Weeks (from Baseline [Week 0] to Endpoint [Week 12])|Participants included in this analysis were exposed to study medication for at least 2 weeks. Participants in the Control Group were excluded from this analysis because they did not receive study medication and, therefore, cannot be categorized into Treatment Responders vs. Treatment Non-Responders.|||Participants|||Count of Participants
2618390|NCT01972061|Other Pre-specified|Number of Urinary Voids Per Day|Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation) and week 3 (post foot stimulation)|Week 1, Week 2, Week 3||||urinary voids per day||Standard Deviation|Mean
2618391|NCT01972061|Other Pre-specified|Bladder Volume as Recorded on CMG for Strong Desire to Void|Subject reports to the clinic for two CMGs. CMG #1 is the baseline measurement. CMG #2 is recorded during Foot Stimulation|CMG #1 and CMG#2||||ml|||Number
2618392|NCT01972061|Secondary|Number of Urinary Urgency Episodes Per Day|Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation), and week 3 (post foot stimulation). The average number per day urinary urgency episodes was calculated for week 1 and week 2 for each subject.|Week 1, Week 2, Week 3||||Urinary urgency episodes per day||Standard Deviation|Mean
2618393|NCT01972061|Primary|Number of Urinary Incontinence Episodes Per Day|Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation), and week 3 (post foot stimulation). The average number per day urinary incontinence episodes was calculated for week 1 and week 2 for each subject.|Week 1, Week 2, Week 3||||Urinary Incontinence Episodes||Standard Deviation|Mean
2618394|NCT01971723|Primary|Creatine-Kinase Outcomes||Baseline, 2-week mark, 4-week mark||||mkat/L||Standard Deviation|Mean
2618403|NCT01971723|Primary|Total Testosterone Outcomes|Measurements for testosterone will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark||||ng/dL||Standard Deviation|Mean
2618404|NCT01971723|Primary|Blood Lipid Outcomes|Measurements for blood lipid panels will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark||||mg/dl||Standard Deviation|Mean
2618405|NCT01971723|Primary|Insulin Outcomes|Measurements of insulin will occur on three occasions: prior to the start of supplementation and training, at the end of two weeks, and finally at the end of training.|Baseline, 2-week mark, 4-week mark||||ulU/ml||Standard Deviation|Mean
2618406|NCT01971723|Primary|Strength Performance Outcomes|"Measurement of one repetition maximums strength for all competition lifts included in a standard, ungeared, powerlifting competition (squat, bench, and deadlift). This testing will take place before the supplementation of either T+ or placebo and at the end of the four-week training period.~Each measure was only compared within it's own category against the baseline measurement and against that of the other group at the same time point."|Baseline measures and 4 weeks from start of study||||Kg||Standard Deviation|Mean
2618407|NCT01971645|Secondary|Post-operative Pain Scores|Visual Analogue Scale (VAS) pain scores (0 being no pain and 10 being worst pain) from arrival to post-anesthesia care unit (PACU) to 48 hours after discharge from surgery center.|Immediately post-operatively and up to 48 hours post-discharge, an average of 48 hours||||units on a scale||Inter-Quartile Range|Median
2618408|NCT01971645|Primary|Intra-operative and Post-operative Opioid Consumption|Number of doses of narcotic pain medicine administered during surgery and up to 48 hours after discharge from surgery center.|Intra-operative and up to 48 hours post-discharge, an average of 48 hours||||doses||Inter-Quartile Range|Median
2618409|NCT01971593|Other Pre-specified|Serum Creatinine||Baseline, 6 months, 12 months from eplerenone administration|Outcome analyzed only during the eplerenone period as specified in the protocol|||mg/dl||Standard Deviation|Mean
2618410|NCT01971593|Secondary|Quality of Life|Rand 36-item Short Score Physical Domain Scale (SF-36) Range: 0-100, Higher scores suggest better function|Baseline, 6 months, 12 months from eplerenone administration|Outcome analyzed only during the eplerenone period as specified in the protocol|||Score on a scale||Inter-Quartile Range|Mean
2618411|NCT01971593|Secondary|6 Minute Walk||Baseline, 6 months, 12 months from eplerenone administration|Outcome analyzed only during the eplerenone period as specified in the protocol|||Feet||Standard Deviation|Mean
2618412|NCT01971593|Primary|Galectin 3||Baseline, 6 months and 12 months from eplerenone administration|Outcome analyzed only during the eplerenone period as specified in the protocol|||ng/ml||Standard Deviation|Mean
2618413|NCT01971593|Primary|Procollagen III N-Terminal Peptide||Baseline, 6 months and 12 months from eplerenone administration|Outcome analyzed only during the eplerenone period as specified in the protocol|||ug/ml||Standard Deviation|Mean
2618414|NCT01971593|Primary|Procollagen N-terminal Peptide 1||Baseline, 6 months and 12 months from eplerenone administration|Outcome analyzed only during the eplerenone period as specified in the protocol|||ug/ml||Standard Deviation|Mean
2618415|NCT01971580|Secondary|Quality of Life|Change in Rand 36-item Short Form (SF-36) physical function score (0-100). On the Rand SF-36 questionnaire, a score closer to 100 (higher) suggests lesser disability, while a score closer to 0 (lower) suggests more disability.|12 weeks|In this crossover study, all patients received both therapies. Analysis was performed comparing baseline to after indicated therapy|||Change in score from baseline||95% Confidence Interval|Mean
2618416|NCT01971580|Primary|Change in VO2 Max||Baseline compared to 12 weeks therapy with either ambrisentan or placebo|In this crossover study, all patients received both ambrisentan and placebo. Data was analyzed comparing baseline measures to those after the period on ambrisentan and baseline measures to those after the period on placebo.|||Change in ml/kg min||95% Confidence Interval|Mean
2618417|NCT01971567|Secondary|Change in Baroflex Sensitivity (BRS)|Blood pressure and heart rate are acquired from 10 minute recordings of noninvasive finger arterial pressure measurements and ECG with participants lying quietly, supine. Systolic BP and beat to beat, RR intervals files generated via the data acquisition system at 1000 Hz, are analyzed using Nevrokard BRS software. Analysis is conducted on the first complete 5-minute epoch. Power spectral densities of systolic blood pressure (SBP) and R-R interval (RRI) oscillations are computed by 512 points Fast Fourier Transform (FFT) and integrated over specified frequency ranges (HF: 0.15-0.4 Hz). The square-root of the ratio of RRI's and SBP powers is computed to calculate HF alpha indices, which reflect BRS. The software scans the RRI and SBP records, identifies sequences, and calculates linear correlation between RRI and SBP for each sequence. The mean of all individual regression coefficients (slopes), a measure of sequence BRS, is then calculated for Sequence UP, DOWN and TOTAL (seq ALL).|8-10 weeks after completion of the intervention|Other entries were excluded due to missing or dropped heartbeats and were excluded from the analysis for continuity|||ms/mm Hg||Standard Error|Mean
2618418|NCT01971567|Secondary|Change in Heart Rate Variability (HRV)|Blood pressure and heart rate are acquired from 10 minute recordings of noninvasive finger arterial pressure measurements and ECG with participants lying quietly, supine. Systolic BP and beat to beat, RR intervals files generated via the data acquisition system (BIOPAC acquisition system and Acknowledge 4.2 software, Santa Barbara, CA), at 1000 Hz, are analyzed using Nevrokard BRS software (Nevrokard BRS, Medistar, Ljubljana, Slovenia). Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis. Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval (SDNN, milliseconds)and the root mean square of successive beat-to-beat differences in R-R interval duration (rMSSD milliseconds). For calculation of SDNN, the R-R intervals are visually inspected, and data considered as artifact is manually removed.|Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention|Other entries were excluded due to missing or dropped heartbeats and were excluded from the analysis for continuity|||ms||Standard Error|Mean
2618419|NCT01971567|Secondary|Change From Baseline in EQ-5D|Health-related quality of life will be measured by the EQ-5D. The EQ-5D consists of 5 items assessing an individual's current health status (values from 0-2), yielding scores ranging from 0-10. Higher scores denotes worse outcomes.|Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention||||units on a scale||Standard Error|Mean
2618420|NCT01971567|Secondary|Change From Baseline in Beck Anxiety Inventory (BAI)|Anxiety will be measured by the Beck Anxiety Inventory (BAI). The BAI is a 21-item questionnaire with response values from 0-3 for each item, yielding scores ranging from 0-63. Higher scores denotes worse outcomes.|Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention|Data not collected for one participant in the placebo group|||units on a scale||Standard Error|Mean
2618421|NCT01971567|Secondary|Change From Baseline in Beck Depression Inventory - II (BDI-II)|Depression will be measured by the Beck Depression Inventory-II (BDI-II). The BDI-II is a 21-item questionnaire with response values of 0-3 for each item, yielding scores ranging from 0-63. Higher scores denotes worse outcomes.|Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention||||units on a scale||Standard Error|Mean
2618422|NCT01971567|Secondary|Change in RestRefresh and SleepQual|This will be an online daily sleep diary to evaluate the amount and quality of sleep. This allows evaluation of the timing and trajectory of any improvements in sleep, including appreciation of the presence and duration of placebo effects. Participants were asked to report a self-rating on how well they felt rested and refreshed (RestRefresh) and to rate the quality of sleep they had (SleepQual). Both questions were rated on a 0 to 4 scale and higher scores denotes better outcomes for each.|Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention|Data was not able to be collected for all participants.|||units on a scale||Standard Error|Mean
2618423|NCT01971567|Secondary|Change in Total Sleep Time (TST)|This will be an online daily sleep diary to evaluate the amount and quality of sleep. This allows evaluation of the timing and trajectory of any improvements in sleep, including appreciation of the presence and duration of placebo effects. Participants recorded the total sleep time (TST) they had each night. The outcome indicates the average increase (in hours) of the amount of sleep that each group reported.|Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention|Data was not able to be collected for all participants.|||hours||Standard Error|Mean
2618424|NCT01971567|Secondary|Change From Baseline in Sleep Onset Latency and Wake After Sleep Onset|This will be an online daily sleep diary to evaluate the amount and quality of sleep. This allows evaluation of the timing and trajectory of any improvements in sleep, including appreciation of the presence and duration of placebo effects. Measurements of sleep onset latency (SOL) and wake after sleep onset (WASO) were recorded in minutes.|Baseline and 8-10 weeks after completion of intervention|Data was not able to be collected for all participants.|||minutes||Standard Error|Mean
2618425|NCT01971567|Primary|Change From Baseline in Insomnia Severity Index (ISI)|The ISI is a 7 question, self-reported measure to evaluate symptoms of insomnia, with responses from 0-4 for each question, yielding scores ranging from 0-28. Lower scores represent better outcomes. The primary outcome will be change from enrollment to 8-10 weeks after completion of the intervention.|Collected from the enrollment visit through completion of the primary data collection visit, 8-10 weeks after completion of the intervention||||units on a scale||Standard Error|Mean
2618426|NCT01971554|Secondary|Change From Baseline in 24-Hour Weighted Mean Glucose (24h-WMG) at Day 15|"The 24h-WMG was considered to provide an integrated assessment of the glycemic exposure over the 24-hour period, and was derived from 18 blood samples collected immediately prior to, and after each meal, and overnight and fasting one hour pre-dose. A weighted rather than a simple mean is used to avoid overrepresentation of post-meal glucose values. On each day (Day -1 and Day 14), the WMG was computed as a time-weighted average of the 18 individual measurements."|Baseline and Day 15|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model. Data from 1 participant at Day 14 (Placebo group) was missing as the participant had to leave the study site.|||mg/dL||Standard Error|Least Squares Mean
2618427|NCT01971554|Secondary|Time to Reach Cmax (Tmax)|Tmax is a measure of the time to reach the maximum concentration in the plasma after the dose of study drug. Pharmacokinetic parameter analysis was not performed on the Placebo group.|Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, and 24 hours postdose; Day 14 : Predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours postdose|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model. Pharmacokinetic testing was not performed on the Placebo group.|||hr||Full Range|Median
2618428|NCT01971554|Secondary|Maximum Plasma Drug Concentration After Dosing (Cmax)|Cmax is a measure of the maximum amount of drug in the plasma after the dose of study drug. Pharmacokinetic parameter analysis was not performed on the Placebo group. Method of dispersion for Cmax was geometric mean coefficient of variation percentage.|Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, and 24 hours postdose; Day 14 : Predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours postdose|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model. Pharmacokinetic testing was not performed on the Placebo group.|||μM||Geometric Coefficient of Variation|Geometric Mean
2618429|NCT01971554|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24h)|AUC0-last is a measure of the total amount of drug in the plasma from the dose to 24 hours after the dose of study drug. Pharmacokinetic parameter analysis was not performed on the Placebo group. Method of dispersion for AUC0-24h was geometric mean coefficient of variation percentage.|Day 1: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, and 24 hours postdose; Day 14 : Predose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48, 72 hours postdose|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model. Pharmacokinetic testing was not performed on the Placebo group.|||μM·hr||Geometric Coefficient of Variation|Geometric Mean
2618467|NCT01971086|Secondary|The Single Score of Quality of Life Improvement at the Closing/Final Visit for Quality of Sleep|"The following quality of life improvement question at the final/closing visit were answered by the patients: How did Rhinospray plus improve the quality of your sleep? and How did Rhinospray Plus improve the quality of your sleep?."|Up to day 11|Patients from FAS|||participants|||Number
2618430|NCT01971554|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 14 days|The Safety population consisted of all participants who received at least one dose of study medication.|||Participants|||Number
2618431|NCT01971554|Primary|Number of Participants Who Experienced at Least Once Adverse Event|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 28 days|The Safety population consisted of all participants who received at least one dose of study medication.|||Participants|||Number
2618432|NCT01971554|Primary|Change From Baseline in Fasting Plasma Glucose (FPG) at Day 15|Blood glucose was measured on a fasting basis (collected after an 8-hour fast). Blood was collected on Day -1 (pre-planned dose), predose on Days 1, 3, 7, and 14, and 24h postdose Day 14 (Day 15). The baseline measurement was computed as the average of the Day -1 and predose Day 1 measurements. FPG is expressed as mg/dL. This change from baseline reflects values for Day 15 FPG minus Day 0 FPG values.|Predose (Baseline) and 24 h postdose Day 14 (Day 15)|The Per-Protocol population is the subset of participants who complied with the protocol sufficiently to ensure that these data are likely to exhibit the effects of treatment, according to the underlying scientific model.|||mg/dL||Standard Error|Least Squares Mean
2618433|NCT01971476|Secondary|Half-Life (t1/2) of Volasertib|This outcome measure presents half-life of Volasertib.|Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.|Pharmacokinetic Set: All evaluable patients were included in the PK analysis. A patient was considered to be not evaluable, if the patient had an important protocol violation relevant to the evaluation of PK or had insufficient data.|||h||Geometric Coefficient of Variation|Geometric Mean
2618434|NCT01971476|Secondary|Area Under the Concentration-Time Curve (AUC0-∞, Norm) of Volasertib in Plasma|This outcome measure presents dose normalized area under the concentration-time curve of Volasertib in plasma over the time interval from zero extrapolated to infinity.|Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.|Pharmacokinetic Set: All evaluable patients were included in the PK analysis. A patient was considered to be not evaluable, if the patient had an important protocol violation relevant to the evaluation of PK or had insufficient data.|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2618435|NCT01971476|Secondary|Trough Concentration (Cpre, 2) of Volasertib|"This outcome measure presents pre-dose concentration of Volasertib in plasma immediately before administration of the second dose (Cpre,2).~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.|Pharmacokinetic Set: All evaluable patients were included in the PK analysis. A patient was considered to be not evaluable, if the patient had an important protocol violation relevant to the evaluation of PK or had insufficient data. The number of participants analysed are the number of participants with available data at the timepoint of interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2618436|NCT01971476|Secondary|Maximum Measured Concentration (Cmax, Norm) of Volasertib|This outcome measure presents dose normalized maximum measured concentration of Volasertib in plasma (Cmax, norm).|Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.|Pharmacokinetic Set (PKS): All evaluable patients were included in the PK analysis. A patient was considered to be not evaluable, if the patient had an important protocol violation relevant to the evaluation of PK or had insufficient data.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2618437|NCT01971476|Secondary|Overall Survival (OS) [in Leukaemia Patients]|Overall survival was defined as time from first infusion of Volasertib to death from any cause. For patients who were lost to follow-up, OS were censored on the last date the patients were known to be alive.|Up to 849 days.|"Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|||Months||95% Confidence Interval|Median
2618438|NCT01971476|Secondary|Event-Free Survival (EFS) [in Leukaemia Patients]|EFS was defined as the time from the first infusion of Volasertib to the date of PD or relapse, occurrence of secondary malignancy, or death from any cause, whichever occurred first. EFS was censored at the date of last disease assessment for patients who were not reported with PD, relapse, occurrence of secondary malignancy or death.|Up to 849 days.|"Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|||Months||95% Confidence Interval|Median
2618450|NCT01971346|Secondary|Interferon (IFN)-Alpha Signal Strength|Strength of IFN-alpha signatures will be measured in skin of study subjects at initiation, during and after treatment. The strength of these signals in skin will be done using bioinformatic approach quantifying transcriptional signature of these cytokines. The strength of the cytokine signals will be treated as a response variable in a univariate repeated measure analysis of variance, with PASI response profile and time as covariates. PASI response profile will be categorized according to improvement in PASI score: responders (greater than 75% reduction in PASI from baseline), intermediate-responders (those with greater than 25% and less than 75% reduction in PASI from baseline), and non-responders (less than 25% reduction in PASI from baseline).|Baseline, Week 6, Week 12|PASI response profile is only done for those subjects who completed the study, n=42. Biopsy not completed on one subject at baseline. Tissue not able to be processed for two subjects at baseline, Week 6 and Week 12. Biopsy not completed on three subjects at Week 6 visit. Biopsy not completed on three different subjects at Week 12 visit.|||rpkm||Standard Error|Least Squares Mean
2618439|NCT01971476|Secondary|Best Overall Response [in Leukaemia Patients]: (Complete Remission (CR)), CR With Incomplete Neutrophil or Platelet Recovery (CRi), Partial Remission (PR), Stable Disease (SD), Progressive Disease (PD) and Death in Aplasia|This outcome measure includes, CR: Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary (EM) disease; absolute neutrophil count ≥ 1.0 x 109/L (1000/μL); platelet count ≥80 x 109/L (80000/μL); independence of red blood cells transfusions. CRi: All CR criteria except for residual neutropenia (<1.0 x 109/L [1000/μL]) or thrombocytopenia (<800 x 109/L [80000/μL]), independence of red blood cell transfusions not required. PR: Decrease of bone marrow blast percentage to 5%-25%; decrease of pretreatment bone marrow (baseline) blast percentage by at least 50%; absence of EM disease. SD: Neither qualifies for CR, CRi, PR or PD. PD: At least one of the criteria a) 50% increase in bone marrow blast count over baseline b) 50% increase in peripheral blast count over baseline - evidence of new EM disease - clinically PD based on the judgment of the investigator. Death in aplasia: Deaths occurring ≥7 days after last administration of the trial drug while cytopenic.|Up to 849 days.|"Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|||Participants|||Number
2618440|NCT01971476|Secondary|The Number of Patients With Changes in Cardiac Activity (Prolonged QTc Interval) Reported as Clinically Relevant Observations|"This outcome measure presents the number of patients with changes in cardiac activity (prolonged QTc interval) reported as clinically relevant observations to assess cardiac activity based on Electrocardiogram (ECG) recordings (digital, triplicate) before and at the end of each Volasertib administration and at least at 2 more time points within the first 24 hours after end of the first Volasertib administration. Two methods of heart rate correction of the QT interval were used: the fixed corrections Fridericia's correction (QTcF) and Bazett's correction (QTcB).~SMQ: Standardised Medical Dictionary for Regulatory Activities (MedDRA) query."|Up to 879 days.|Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.|||Participants|||Number
2618441|NCT01971476|Secondary|Number of Patients With Clinically Relevant Laboratory Value Changes of Calcium (Hyper- and/or Hypocalcaemia) as Judged by the Investigator and Reported as AEs, CTCAE Grade ≥3|This outcome measure presents number of patients with clinically relevant laboratory value changes of calcium (hyper- and/or hypocalcaemia) as judged by the investigator and reported as AEs, CTCAE Grade ≥3. CTCAE Grade 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).|Up to 879 days.|Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.|||Participants|||Number
2618442|NCT01971476|Secondary|Number of Patients With Hepatic Injury Defined as Adverse Events of Special Interest (AESI)|This outcome measure presents number of patients with hepatic injury defined as AESI. Hepatic injury was defined by the following alterations of liver parameters: an elevation of Aspartate Transaminase (AST) and/or Alanine Transaminase (ALT) >3x Upper Limit of Normal (ULN) combined with an elevation of total bilirubin >2x ULN measured in the same blood sample.|Up to 879 days.|Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.|||Participants|||Number
2618443|NCT01971476|Primary|Maximum Tolerated Dose of Volasertib|This outcome measure presents MTD of Volasertib. The MTD was defined as the highest dose level at which DLTs were reported in not more than 1 in 6 evaluable patients during Cycle 1.|Up to 14 days.|Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.|||mg|||Number
2618444|NCT01971476|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)|This outcome measure presents number of participants with DLTs in the first cycle for the determination of MTD. DLTs were defined as drug related Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (haematological and nonhaematological) Adverse Events (AEs) with the exception of a) Reduced blood cell count (any grade) without associated clinical complications qualifying for DLT. b) Febrile neutropenia Grade 3. c) Infection Grade 3 with neutrophil count <1000/mm3. d) Uric acid Grade ≥3. e) Nausea, vomiting and/or diarrhoea managed by adequate therapy (i.e. recovery to CTCAE Grade ≤2).|Up to 14 days.|Treated Set: The treated set consisted of all patients who have received at least 1 dose of trial medication at the time of clinical cut-off.|||Participants|||Number
2618445|NCT01971463|Primary|The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS).|contralesional hemisphere|30 minutes after completion of saline bolus||||percent change from baseline flow||Inter-Quartile Range|Median
2618446|NCT01971463|Primary|The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS).|Ipsilesional hemisphere|30 minutes after completion of saline bolus||||percent change from baseline flow||Inter-Quartile Range|Median
2618447|NCT01971385|Secondary|Number of Adverse Events Reported|To assess the safety and tolerability of squaric acid solution the number of adverse events in each treatment arm will be collected and compared.|8 months|||||||
2618448|NCT01971385|Primary|Subjects With at Least One Form of Contact With Study Staff With no Herpes Labialis Outbreaks Within 119 Days of Sensitization|Percent of subjects with no reported herpes labialis outbreak within 119 days of sensitization over total number of subjects after one form of contact with study staff|8 months|Because most patients who received 2% SADBE for sensitization did not experience another herpes outbreak and thus did not receive a subsequent treatment dose, we grouped both squaric acid treatment arms together for analysis since both groups had received the same sensitization dose of 2%.|||percentage of particpants|||Number
2618449|NCT01971346|Secondary|Psoriasis Area and Severity Index (PASI) Response Profile|Subjects will be categorized according to improvement in Psoriasis Area and Severity Index (PASI) score: responders (greater than 75% reduction in PASI from baseline), intermediate-responders (those with greater than 25% and less than 75% reduction in PASI from baseline), and non-responders (less than 25% reduction in PASI from baseline).|12 Weeks||||Participants|||Count of Participants
2618465|NCT01971086|Secondary|Subjective Assessment of the Patient of Overall Treatment Efficacy at the Closing/Final Visit.|The efficacy of the treatment was rated by the patient at the closing/final visit.|up to day 11|Patients from FAS|||participants|||Number
2618451|NCT01971346|Secondary|Tumor Necrosis Factor (TNF)-Alpha Signal Strength|Strength of TNF-alpha signatures will be measured in skin of study subjects at initiation, during and after treatment. The strength of these signals will be done using bioinformatic approach quantifying transcriptional signature of these cytokines. The strength of the cytokine signals will be treated as a response variable in a univariate repeated measure analysis of variance, with PASI response profile and time as covariates. PASI response profile will be categorized according to improvement in PASI score: responders (greater than 75% reduction in PASI from baseline), intermediate-responders (those with greater than 25% and less than 75% reduction in PASI from baseline), and non-responders (less than 25% reduction in PASI from baseline).|Baseline, Week 6, Week 12|PASI response profile is only done for those subjects who completed the study, n=42. Biopsy not completed on one subject at baseline. Tissue not able to be processed for two subjects at baseline, Week 6 and Week 12. Biopsy not completed on three subjects at Week 6 visit. Biopsy not completed on three different subjects at Week 12 visit.|||rpkm||Standard Error|Least Squares Mean
2618452|NCT01971346|Primary|Change in Psoriasis Area and Severity Index (PASI) Score|A cumulative change in PASI score from baseline to week 12 will be calculated for each patient. The PASI is the industry standard to decrease/eliminate subjectivity in determining psoriasis severity. It is a quantitative rating scale for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. The severity of plaque characteristics (erythema, thickness and scaling) for body regions (head, upper limbs, trunk and lower limbs) is combined with the degree of plaque involvement in each body region to determine a single PASI score in the range of 0 (no disease) and 72 (maximal disease).|Baseline, 12 weeks|Only those subjects who finished the study (have a Week 0 and Week 12 visit with recorded PASI) are included in the analysis assessing a change from baseline.|||units on a scale||Standard Error|Mean
2618453|NCT01971255|Secondary|Number of Participants With Influenza Symptoms|This was determined by the presence or absence of influenza symptoms.|within 68 days after inoculation|The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)|||participants|||Number
2618454|NCT01971255|Secondary|Number of Symptoms|A simple count of the number of unique influenza symptoms the participant experienced.|within 68 days after inoculation|The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)|||Number||Inter-Quartile Range|Median
2618455|NCT01971255|Primary|Number of Patients With Mild to Moderate Influenza Disease (MMID)|This was determined by presence of the combination of symptoms of influenza and presence of a positive clinical test for influenza. If both were present then the participant had positive MMID.|Within 10 days of inoculation|The analysis included only those subjects who received the influenza challenge virus and were not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.) In addition this represents the number of people who were high or low titer at the time of challenge with influenza virus not at screening.|||participants|||Number
2618456|NCT01971255|Secondary|Duration of Symptoms (Days)|The number of days a participant experienced any influenza symptoms|within 68 days after inoculation|The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)|||Days||Inter-Quartile Range|Median
2618457|NCT01971255|Secondary|Duration of Shedding (Days)|The number of days total from the time a participant had the first positive test for influenza to their last positive test.|Within 14 days of inoculation|The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)|||Days||Inter-Quartile Range|Median
2618458|NCT01971255|Secondary|Clinical Disease Severity Score|This was measured using a validated participant directed questionnaire called FLUPRO. This is then scored daily with a range of score from 0-185. The total score is the sum of all time points the questionnaire is given, which is 16 time points. Therefore the total score range is from 0-2960. 0 would represent no symptoms over the 16 time points while 2960 would represent maximum symptoms and perceived severity at all 16 time points.|Within 28 days after inoculation|The analysis included only those subjects who received the influenza challenge virus and was not found to have a confounding infection (i.e. other respiratory virus infection, urinary tract infection, etc.)|||units on a scale||Inter-Quartile Range|Median
2618459|NCT01971203|Primary|MADRS|Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-administered, with overall score ranges from 0 (normal) to 54 (severe depression). Score at 16 weeks as compared to baseline.|baseline and 16 weeks||||units on a scale||Standard Deviation|Mean
2618460|NCT01971203|Secondary|Changes in Sexual Functioning Questionnaire (CSFQ)|Changes in Sexual Functioning Questionnaire (CSFQ) at week 16 as compared to baseline. The CSFQ assesses interest, functioning, and satisfaction in sex on a six-point scale, where 1 is greater than normal and 6 is totally absent, with full range from 5 (greater than normal) to 30 (totally absent).|baseline and week 16||||units on a scale||Standard Deviation|Mean
2618461|NCT01971203|Secondary|Clinical Global Impression Scales for Severity and Improvement|The Clinical Global Impression Scales for Severity and Improvement (CGI-I and CGI-S), both clinician rated, measures overall severity of symptoms and level of improvement on a seven-point scale from 0 (not applicable or not assessed) to 7, where 7 is the most severe. In order for a participant to be considered a treatment responder, he or she must receive a score of 1 (not ill or very much improved) or 2 (borderline mentally ill or much improved).|up to 16 weeks||||units on a scale||Standard Deviation|Mean
2618462|NCT01971203|Secondary|HAM-A|Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item clinician-administered scale measuring symptoms with total scale from 0 (not present) to 56 (severe) to severe anxiety.|baseline and 16 weeks||||units on a scale||Standard Deviation|Mean
2618463|NCT01971086|Secondary|Subjective Assessment of the Patient of Overall Treatment Tolerability at the Closing/Final Visit.|The efficacy of the treatment was rated by the patient at the closing/final visit.|up to day 11|Patients from TS|||participants|||Number
2618464|NCT01971086|Secondary|Subjective Assessment of the Physicians of Overall Treatment Tolerability at the Closing/Final Visit.|The tolerability of the treatment was rated by the physician at the closing/final visit for every patient.|up to day 11|Patients from TS.|||participants|||Number
2618468|NCT01971086|Secondary|The Single Score of Quality of Life Improvement at the Closing/Final Visit for Daytime Activities|"The following quality of life improvement question at the final/closing visit were answered by the patients: How did Rhinospray plus improve the quality of your daytime activities?"|up to 11 days|Patients from FAS|||participants|||Number
2618469|NCT01971086|Secondary|The Change From Baseline in the Single Symptoms Scores ( Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit|Patients scored the single symptoms (blocked nose, sneezing and running nose) at the end of each treatment day on a 4-point rating scale with 0=absent, 1=mild, 2=moderate, 3=severe. The changes in the 3 single scores were calculated by the single score at the final visit minus the single score at baseline. Therefore, a negative change represents an improvement of the single scores.|Baseline and up to day 11|Patients from FAS.|||units on a scale||Full Range|Median
2618470|NCT01971086|Primary|The Mean of the 2 Single Quality of Life Improvement Scores at the Closing/Final Visit for Daytime Activities and Quality of Sleep|"The mean score of the following two quality of life improvement questions at the final/closing visit was calculated: How did Rhinospray plus improve the quality of your daytime activities? and How did Rhinospray Plus improve the quality of your sleep?. The scores range from 1=strongly to 4=no improvement. Thus also the range of the mean score is from 1 to 4."|up to day 11|Patients from FAS|||units on a scale||Full Range|Median
2618471|NCT01971086|Primary|The Change From Baseline in the Mean of the 3 Single Symptom Scores (Blocked Nose, Sneezing and Running Nose) at the Closing/Final Visit.|Patients scored the symptoms (blocked nose, sneezing and running nose) on a 4-point rating scale with 0=absent, 1=mild, 2=moderate, 3=severe. The range of the mean score thus could be between 0 and 3. The change in the mean of the 3 single scores was calculated by the score at the final visit minus the score at baseline. Therefore, a negative change represents an improvement of the mean score.|Baseline and up to day 11|Patients from the Full Analysis Set (FAS) which includes all patients in the TS who have analysable data in at least one efficacy endpoint.|||units on a scale||Full Range|Median
2618472|NCT01970995|Primary|Concentration of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol) (Total NNAL)|"Concentrations measured at Day 90 in urine, adjusted for creatinine.~Geometric Least Squares (LS) means are provided as descriptive statistics."|90 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the period Day 60 to Day 90.|||pg/mg creat||95% Confidence Interval|Least Squares Mean
2618473|NCT01970995|Primary|Levels of Carboxyhemoglobin (COHb)|"% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.~Geometric Least Squares means are provided as descriptive statistics."|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.|||% of saturation of hemoglobin||95% Confidence Interval|Least Squares Mean
2618474|NCT01970995|Primary|Concentration of S-phenylmercapturic Acid (S-PMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares (LS) means are provided as descriptive statistics."|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.|||pg/mg creat||95% Confidence Interval|Least Squares Mean
2618475|NCT01970995|Primary|Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares (LS) means are provided as descriptive statistics."|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.|||ng/mg creat||95% Confidence Interval|Least Squares Mean
2618476|NCT01970995|Primary|Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares (LS) means are provided as descriptive statistics."|5 days|The analysis was performed on the Per Protocol set (PP) which included all randomized subjects who had no major protocol deviation impacting the evaluability during the confinement period.|||pg/mg creat||95% Confidence Interval|Least Squares Mean
2618477|NCT01970982|Primary|Levels of Carboxyhemoglobin (COHb)|"% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."|||% of saturation of hemoglobin||95% Confidence Interval|Least Squares Mean
2618478|NCT01970982|Primary|Concentration of S-phenylmercapturic Acid (S-PMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."|||pg/mg creat||95% Confidence Interval|Least Squares Mean
2618479|NCT01970982|Primary|Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."|||ng/mg creat||95% Confidence Interval|Least Squares Mean
2618480|NCT01970982|Primary|Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares LS) means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid biomarker of exposure (BoExp) measurement (THS 2.2, CC, SA arms)."|||pg/mg creat||95% Confidence Interval|Least Squares Mean
2618481|NCT01970943|Secondary|PET Diprenorphine|We sought to find if endogenous opioid levels and endogenous opioid release induced by placebo administration differentiates between the no intervention first, then placebo group compared to the placebo first, then no intervention group in migraine patients.|1 day|9 migraine subjects|||standard uptake value||Standard Deviation|Mean
2618482|NCT01970943|Secondary|Pain Stimulation fMRI BOLD Signal|"We imaged the subjects under an MRI scan. All data was collected on a Siemens 3 Tesla MR scanner using a PETcompatible eight-channel head coil. Structural T1 weighted MPRAGE Functional scans were preprocessed using slice timing correction, realignment, normalization, and smoothing (8 mm FWHM Gaussian filter), using SPM12. In each condition (placebo & no drug) subjects underwent four sets of pain stimulation at high and low temperatures (somatosensory control condition). The stimuli were modeled as boxcar time series, with additional regressors for temperature ramp-up, ramp-down, pain rating sequence, and six motion regressors.data were collected for each of the two PET-MR scans. Contrasts analyzed included pain stimulation.~The values for the 8 sets of stimulation, for both the migraine and the healthy group are combined"|1 day|9 migraine subjects|||arbitrary units||Standard Deviation|Mean
2618483|NCT01970943|Secondary|Pain Anticipation fMRI BOLD Signal|"We imaged the subjects under an MRI scan. All data was collected on a Siemens 3 Tesla MR scanner using a PETcompatible eight-channel head coil. Structural T1 weighted MPRAGE Functional scans were preprocessed using slice timing correction, realignment, normalization, and smoothing (8 mm FWHM Gaussian filter), using SPM12. In each condition (placebo & no drug) subjects underwent four sets of pain anticipation at high and low temperatures (somatosensory control condition). The stimuli were modeled as boxcar time series, with additional regressors for temperature ramp-up, ramp-down, pain rating sequence, and six motion regressors.data were collected for each of the two PET-MR scans. Contrasts analyzed included pain anticipation.~The values for the 8 sets of anticipation, for both the migraine and the healthy group are combined"|1 day|9 migraine subjects|||arbitrary units||Standard Deviation|Mean
2618484|NCT01970943|Primary|Visual Analogue Scale (VAS) 0-10 Pain Rating|"This study will investigate how placebo may reduce experimental pain induced by contact heat.~Patients rate heat stimulus intensity on a 0-10 scale, where 0 is no pain, and 10 is most intense pain possible. Data is reported to the placebo condition.~The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'most intense pain possible'. The patient is asked to mark his pain level on the line between the two endpoints."|1 day||||units on a scale||Standard Deviation|Mean
2618485|NCT01970878|Secondary|Change From Baseline in Average Daily Rescue Ventolin Use|Subjects recorded in their diary the number of puffs of rescue Ventolin HFA taken on each study day. The subject's average daily number of puffs of rescue Ventolin HFA was calculated over the entire 52-week treatment period. Missing values were ignored in both the numerator and denominator. Diary data recorded during the last 7 days of the 10-14 day screening period were used to calculate the baseline average. Change in rescue Ventolin HFA use was calculated by subtracting the baseline average from the 52-week average.|Baseline through Week 52|Subjects in the ITT population from the lead-in studies who had data for the parameter|||Puffs per day||95% Confidence Interval|Least Squares Mean
2618486|NCT01970878|Secondary|Change From Baseline in SGRQ Total Score|The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (best possible health status) to 100 (worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life. SGRQ Total Score was assessed at multiple visits post-baseline, and a model-based average of all visits starting from Week 12 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average SGRQ Total Score post-baseline.|Baseline and Weeks 12 to 52|Subjects in the ITT population from the lead-in studies who had data for the parameter|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2618487|NCT01970878|Secondary|Peak Change From Baseline in FEV1 Within 2 Hrs Post-dosing|Peak change from Baseline FEV1 Over 52 Weeks is a Model-Based Average (ITT Population). Peak FEV1 was assessed at multiple visits post-baseline, and a model-based average of all visits starting from Week 2 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average Peak FEV1 post-baseline.|Baseline and Weeks 2 to 52|Subjects in the ITT population from the lead-in studies who had data for the parameter.|||Liters||95% Confidence Interval|Least Squares Mean
2618488|NCT01970878|Secondary|Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks|SAC TDI focal score over 52 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9.|Baseline and Weeks 4 to 52|Subjects in the ITT population from the lead-in studies who had data for the parameter.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2618489|NCT01970878|Primary|Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks|Change From Baseline in Morning Pre-Dose Trough FEV1 Over 52 Weeks as a Model-Based Average (ITT Population). FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.|Baseline and Weeks 2 to 52|Subjects in the ITT population from the lead-in studies who had data for the parameter.|||Liters||95% Confidence Interval|Least Squares Mean
2618490|NCT01970865|Secondary|Change From Baseline in Total Scores for International Shopping List Test-Delayed Recall (Cognitive Function Assessment) (Phase 2)|This test was performed in the same way as the International Shopping List Test, with the exception that, the delayed recall condition required the participant to recall the words from the list 15 30 minutes later without having the list read again. During the recognition condition, the qualified personnel read a shopping list item that may or may not have been on the original list and the participant had to respond either affirmatively (if the item was on the original list) or negatively (if it was not). Total number of correct responses made in remembering the word list after a delay was recorded. Lower values of least square mean change from baseline indicate performance decline. Upper limit of 95% confidence interval of -0.00 or lower indicate statistically significant decline of performance over baseline at that cycle.|Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)|The analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment.|||units on a score||95% Confidence Interval|Least Squares Mean
2618491|NCT01970865|Secondary|Change From Baseline in Total Scores for International Shopping List Test (Cognitive Function Assessment) (Phase 2)|The International Shopping List task is a measure of verbal learning and uses a well validated list learning paradigm administered using a computer. High frequencies, high imagery, concrete nouns (items from a shopping list) were read to the participant at the rate of one word every 2 seconds. Once all 12 words had been read, the participant was asked to recall as many of the words as quickly as possible. The words recalled by the participant were marked on the computer screen. When the participant could recall no more words, the same list was read again. The words recalled by the participant were recorded. This was then repeated a third time. Total number of correct responses on 3 consecutive trials at a single assessment was recorded. Lower values of least square mean change from baseline indicate performance decline. Upper limit of 95% confidence interval of -0.00 or lower indicate statistically significant decline of performance over baseline at that cycle.|Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)|The analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment.|||units on a score||95% Confidence Interval|Least Squares Mean
2618492|NCT01970865|Secondary|Change From Baseline in Total Scores for One Back Test (Cognitive Function Assessment) (Phase 2)|"The One Back Test is a measure of working memory and uses a well validated n back paradigm with playing cards. In this task, the on-screen instructions ask: Is the previous card the same?. A playing card is presented in the center of the screen. The participant must decide whether the card is the same as the previous card. If it is the same the participant should press Yes, and if not press No. The participant is encouraged to work as quickly and accurately as possible. The speed and accuracy of each response are recorded, mean of the log10 transformed reaction times for correct responses is used to demonstrate speed of performance, and the arcsine transformation of the square root of the proportion of correct responses is used to demonstrate accuracy. Lower values of least square mean change from baseline indicate performance decline. Upper limit of 95% confidence interval of -0.00 or lower indicate statistically significant decline of performance over baseline at that cycle."|Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)|The analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment.|||units on a score||95% Confidence Interval|Least Squares Mean
2618493|NCT01970865|Secondary|Change From Baseline in Total Scores for Identification Test (Cognitive Function Assessment) (Phase 2)|"The Identification Test is a measure of visual attention and uses a well validated choice reaction time paradigm with playing card stimuli. In this task, the playing cards are all red or black jokers. The on-screen instructions ask: Is the card red?. A playing card is presented face down in the center of the screen. The card flips over so it is face up. As soon as it flips over the participant must decide whether the card is red or not. If it is red the participant should press Yes, and if it is not red the participant should press No. The participant is encouraged to work as quickly and accurately as possible. The speed and accuracy of each response are recorded and mean of the log10 transformed reaction times for correct responses is calculated. Lower values of least square mean change from baseline indicate performance decline. Upper limit of 95% confidence interval of -0.00 or lower indicate statistically significant decline of performance over baseline at that cycle."|Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)|The analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment.|||units on a score||95% Confidence Interval|Least Squares Mean
2618494|NCT01970865|Secondary|Change From Baseline in Total Scores for Detection Test (Cognitive Function Assessment) (Phase 2)|"The Detection Test is a measure of psychomotor function and uses a well validated simple reaction time paradigm with playing card stimuli. In this test, the on-screen instructions ask: Has the card turned over?. A playing card is presented face down in the center of the screen. The card flips over so it is face up. As soon as the card flips over the participant must press Yes. The participant is encouraged to work as quickly as they can and be as accurate as possible. The speed and accuracy of each response are recorded and mean of the log10 transformed reaction times for correct responses is calculated. Lower values of least square mean change from baseline indicate performance decline. Upper limit of 95% confidence interval of -0.00 or lower indicate statistically significant decline of performance over baseline at that cycle."|Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)|The analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment.|||units on a score||95% Confidence Interval|Least Squares Mean
2618495|NCT01970865|Secondary|Change From Baseline in Total Scores for Beck Depression Inventory (BDI)-II (Mood Assessment) (Phase 2)|The Beck Depression Inventory (BDI)-II is a 21-item self-report scale, with each item rated by participants on a 4-point scale (ranging from 0-3). The scale includes items capturing mood, (loss of pleasure, sadness, and irritability), suicidal ideation, and cognitive signs (punitive thoughts, self-criticism, self-dislike, pessimism, and poor concentration) as well as somatic signs (appetite, sleep, fatigue and libido). Scores were obtained by adding up the total points from the series of answers. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are as follows: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.|Baseline, Day 1 of Cycles 2-5, Day 1 of every other cycle from Cycle 6, and end of treatment (up to 3 years)|The analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment.|||units on score||95% Confidence Interval|Least Squares Mean
2618496|NCT01970865|Secondary|Number of Participants With Suicidal Ideation and Suicidal Behavior (Phase 2)|The Columbia Suicide Severity Rating Scale (C-SSRS) was used to analyze participants' suicidal ideation and behavior, and it is a unique, simple and short method of assessing both behavior and ideation that tracks all suicidal events and provides a summary of suicidality. It assesses the lethality of attempts and other features of ideation (frequency, duration, controllability, reasons for ideation and deterrents), all of which are significantly predictive of completed suicide.|3 years|The analysis set included all enrolled participants who received study treatment, had a baseline test assessment and at least 1 on-study test assessment.|||Participants|||Count of Participants
2624501|NCT01923480|Secondary|Plasma Concentration of Phenylalanine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
2618497|NCT01970865|Secondary|Number of Participants With Absolute Values and Change From Baseline in QTcF Meeting Pre-defined Criteria (Phase 1 and Phase 2)|Triplicate 12-lead electrocardiograms (ECGs) were performed approximately 2 minutes apart to determine mean QTc interval (QT interval corrected for heart rate). QT interval was corrected for heart rate using Fridericia's formula to provide QTcF. Absolute values and changes from baseline were summarized according to pre-defined criteria. Baseline was defined as the last evaluation on or prior to the first dose of study treatment.|Phase 1: baseline, Days 1, 8 and 15 of Cycle 1, Day 1 of Cycles 2-25, end of treatment (up to 3 years); Phase 2: baseline, Days 1, 8 and 15 of Cycle 1, Day 1 of Cycles 2-5, end of treatment (up to 3 years)|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.|||Participants|||Count of Participants
2618498|NCT01970865|Secondary|Number of Participants With Maximum Decrease From Baseline Greater Than or Equal to 20 Percent in Left Ventricular Ejection Fraction (LVEF) (Phase 1 and Phase 2)|Left Ventricular Ejection Fraction (LVEF) was determined by electrocardiogram (ECG) measurement. Baseline was defined as the measurement prior to the first dose of study treatment.|Baseline, Day 1 of Cycles 2-3, Day 1 of every other cycle from Cycle 5 up to 18 months for Phase 1 (up to 30 months for Phase 2), every 4 cycles thereafter, and end of treatment (up to 3 years)|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.|||Participants|||Count of Participants
2618499|NCT01970865|Secondary|Number of Participants With Vital Signs Data Meeting Pre-defined Criteria (Phase 1 and Phase 2)|Blood pressure (BP), including systolic BP (SBP) and diastolic BP (DBP), and pulse rate were recorded in sitting position. Body weight was also measured.|Baseline, Days 1, 8 and 15 of Cycle 1, Day 1 of Cycles 2-25 for Phase 1 (Cycles 2-38 for Phase 2), Day 1 of every other cycle thereafter, end of treatment (up to 3 years)|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.|||Participants|||Count of Participants
2618500|NCT01970865|Secondary|Number of Participants With Laboratory Abnormalities (Phase 1 and Phase 2) - Coagulation, Lipids and Urinalysis|Coagulation evaluation included activated partial thromboplastin time, international normalized ratio (INR), and prothrombin time. Lipid evaluation included total cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL) and triglycerides. Urinalysis included urine protein and urine blood.|3 years|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.|||Participants|||Count of Participants
2618501|NCT01970865|Secondary|Number of Participants With Laboratory Abnormalities (Phase 1 and Phase 2) - Chemistry|Chemistry evaluation included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose (non-fasted), albumin, phosphorus or phosphate, serum total amylase and serum lipase.|3 years|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.|||Participants|||Count of Participants
2618502|NCT01970865|Secondary|Number of Participants With Laboratory Abnormalities (Phase 1 and Phase 2) - Hematology|Hematology evaluation included hemoglobin, platelets, white blood cell, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils and absolute basophils.|3 years|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.|||Participants|||Count of Participants
2618503|NCT01970865|Secondary|Number of Participants With Treatment-Emergent Adverse Events (Phase 1 and Phase 2)|AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.|3 years|The safety analysis set included all enrolled participants who received at least 1 dose of PF-06463922.|||Participants|||Count of Participants
2618504|NCT01970865|Secondary|Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 2)|EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms, and improvement was defined as a decrease of at least 10 points, worsening was defined as an increase of at least 10 points. All scales which had not improved nor worsened were considered stable.|3 years|Patient reported outcome (PRO) evaluable analysis set included all enrolled participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment.|||Participants|||Count of Participants
2618505|NCT01970865|Secondary|Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 2)|European Organisation for Research and Treatment of Cancer Core Quality of Life Questionaires (EORTC QLQ)-C30 (version 3.0) consists of 30 questions assessing 5 functional domains (physical, role, emotional, cognitive and social), global quality of life (QoL), disease/treatment related symptoms (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation and diarrhoea), and the perceived financial impact of disease. Each scale was transformed to a range of 0 to 100 using standard EORTC algorithm. For global QoL and functional scales, higher score indicate better performance, and improvement was defined as an increase of at least 10 points, worsening was defined as a decrease of at least 10 points. For symptom scales, higher score indicates worse symptoms, and improvement was defined as a decrease of at least 10 points, worsening was defined as an increase of at least 10 points. All scales which had not improved nor worsened were considered stable.|3 years|Patient reported outcome (PRO) evaluable analysis set included all enrolled participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment.|||Participants|||Count of Participants
2624502|NCT01923480|Secondary|Plasma Concentration of Ornithine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
2618506|NCT01970865|Secondary|Number of Participants With ALK Mutation Based on Tumor Tissue Analysis (Phase 2)|Tumor tissues from archived tissue specimens and/or a de novo biopsy were analyzed for ALK kinase domain mutations. Number of participants with one or more ALK mutations is presented.|Screening|Tumor Tissue analysis set included all participants of the ITT analysis set who had at least 1 molecular tumor biomarker assayed from either the screening archival or screening de novo tumor biopsy sample (or both).|||Participants|||Count of Participants
2618507|NCT01970865|Secondary|Number of Participants With ALK Mutation Based on Plasma CNA Analysis (Phase 2)|Plasma CNA samples were analyzed for ALK kinase domain mutations by Next Generation Sequencing (NGS). Number of participants with one or more ALK mutations is presented.|Screening|CNA peripheral blood analysis set included all participants of the ITT analysis set who had at least 1 molecular biomarker assayed.|||Participants|||Count of Participants
2618508|NCT01970865|Secondary|Steady State Accumulation Ratio (Rss) of PF-06463922 Following Multiple Oral Doses (Phase 2)|Rss was calculated as Day 15 AUCtau/Day -7 AUCinf, where AUCtau was the area under the plasma concentration-time profile from time 0 to time tau (24 hours for QD dosing regimen which was adopted in Phase 2), and AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||ratio||Standard Deviation|Mean
2618509|NCT01970865|Secondary|Observed Accumulation Ratio (Rac) of PF-06463922 Following Multiple Oral Doses (Phase 2)|Rac was calculated as Day 15 AUCtau/Day -7 AUCtau, where AUCtau was the area under the plasma concentration-time profile from time 0 to time tau (24 hours for QD dosing regimen which was adopted in Phase 2).|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||ratio||Standard Deviation|Mean
2618510|NCT01970865|Secondary|Terminal Half-Life of PF-06463922 (Phase 2)|Terminal plasma half-life was defined as the time measured for the plasma concentration to decrease by one half, and calculated as loge(2)/kel, where kel was the rate constant for terminal phase.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||hours||Standard Deviation|Mean
2618511|NCT01970865|Secondary|Apparent Volume of Distribution (Vz/F) of PF-06463922 (Phase 2)|Vz/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug, and calculated as dose/(AUCinf*kel), where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time, kel was the rate constant for terminal phase.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||liters||Geometric Coefficient of Variation|Geometric Mean
2618512|NCT01970865|Secondary|Apparent Oral Clearance (CL/F) of PF-06463922 (Phase 2)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose/AUCinf, where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||liter/hour||Geometric Coefficient of Variation|Geometric Mean
2618513|NCT01970865|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06463922 (Phase 2)|Tau refers to the dosing interval, and it equals to 24 hours for QD dosing which was adopted in Phase 2. AUCtau was determined using linear/log trapezoidal method.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2618514|NCT01970865|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06463922 (Phase 2)|AUCinf was calculated as AUClast + (Clast*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the rate constant for terminal phase.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2618515|NCT01970865|Secondary|Time for Cmax (Tmax) of PF-06463922 (Phase 2)|Tmax of PF-06463922 was observed directly from data as time of first occurrence.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||hours||Full Range|Median
2618516|NCT01970865|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-06463922 (Phase 2)|Maximum observed plasma concentration (Cmax) of PF-06463922 was observed directly from data.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK concentration analysis set of PF-06463922 included all participants treated who had at least 1 concentration of PF-06463922.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2618517|NCT01970865|Secondary|Overall Survival (Phase 2)|OS was defined as the time from first dose to the date of death due to any cause. For participants still alive at the time of analysis, the OS time was censored on the last date the participants were known to be alive. Estimates of OS and its 95% confidence interval were determined using Kaplan-Meier method.|3 years|The intent-to-treat (ITT) analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.|||months||95% Confidence Interval|Median
2618518|NCT01970865|Secondary|Progression-Free Survival (PFS) (Phase 2)|PFS was defined as the time from the first dose of study treatment to the first documentation of objective disease progression or to death on study due to any cause, whichever came first. Results presented here were based on independent central review.|3 years|PFS analysis set included all participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.|||months||95% Confidence Interval|Median
2618519|NCT01970865|Secondary|Probability of First Event Being a Central Nervous System (CNS) Progression, Non CNS Progression, or Death (Phase 2)|"The probability of the first event being a CNS progression, a non-CNS progression, or death was evaluated with a competing risk approach by estimating cumulative incidence functions (range: 0-1) relative to the analysis set. The time to first event being a Competing Event (either CNS progression or non CNS progression or Death) was defined as time from first dose until the date of that specific event. Participants not known to have any of the Competing Events were censored on the date they were last assessed for disease status for PFS. Participants who presented one type of event were counted as a competing cause of failure for the analysis of other type of events. For each type of event, the cumulative incidence function corresponding to the nearest time point preceding 1 year is presented. The results are based on independent central review."|3 years|The intent-to-treat (ITT) analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.|||probability|||Number
2618520|NCT01970865|Secondary|Time to Tumor Progression （TTP) and Intracranial TTP (Phase 2)|Time to progression (TTP) was defined as the time from the first dose of study treatment to the first documentation of objective disease progression. Intracranial TTP was defined as the time from the first dose of study treatment to the date of the first documentation of objective progression of intracranial disease, based on either new brain metastases or progression of existing brain metastases. Results presented here were based on independent central review.|3 years|ITT analysis set was used for TTP determination and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; ITT participants with CNS metastases were analyzed for intracranial TTP.|||months||95% Confidence Interval|Median
2618521|NCT01970865|Secondary|Time to Progression (TTP) on the Last Prior Therapy (Phase 2)|TTP on the last prior therapy was defined as time from the first dose date of the last prior treatment regimen to the date of progression.|3 years|The intent-to-treat (ITT) analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922. As planned, this outcome measure was not analyzed for EXP-1 and EXP-6 groups.|||months||95% Confidence Interval|Median
2618522|NCT01970865|Secondary|Percentage of Participants Achieving Disease Control and Intracranial Disease Control at 12 Weeks (Phase 2)|Tumor response was evaluated according to RECIST version 1.1, and disease control was defined as confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD). Intracranial assessment was only performed for participants CNS metastases. Results presented here were based on independent central review.|12 weeks|The intent-to-treat (ITT) analysis set was used for overall response assessment, and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with CNS metastases in the ITT analysis set was used for intracranial response assessment.|||percentage of participants||95% Confidence Interval|Number
2618523|NCT01970865|Secondary|Duration of Response (DOR) and Intracranial DOR (Phase 2)|Duration of Response (DOR) was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first. DOR was only calculated for the subgroup of participants with a confirmed objective tumor response. Intracranial DOR was only calculated for participants with confirmed intracranial objective response. Results presented here were based on independent central review.|3 years|DOR analysis set included all ITT participants who had confirmed objective response; intracranial DOR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response.|||months||95% Confidence Interval|Median
2618524|NCT01970865|Secondary|Time to Tumor Response (TTR) and Intracranial TTR (Phase 2)|Time to tumor response (TTR) was defined as the time from the first dose of study treatment to the first documentation of objective tumor response (CR or PR). For participants whose objective response proceeded from PR to CR, the onset of PR was taken as the onset of response. TTR was only calculated for the subgroup of participants with a confirmed objective tumor response. Intracranial TTR was only calculated for participants with confirmed intracranial objective response. Results presented here were based on independent central review.|3 years|TTR analysis set included all ITT participants who had confirmed objective response; intracranial TTR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response.|||months||Full Range|Median
2618525|NCT01970865|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Score (Phase 1)|In Phase 1, the MMSE was collected to assess mental status. The MMSE is a 30 item questionnaire that tests 5 areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. The MMSE was removed under Amendment 6 of the study protocol, and not required for Phase 2, as the tool was not considered meaningful for assessment of cognitive function.|Baseline, Day 1 of each cycle, and end of treatment (up to 3 years)|MMSE assessment evaluable analysis set included all participants in the safety analysis set (all participants who received at least 1 dose of PF-06463922) who completed a baseline and at least 1 post-baseline assessment.|||units on a score||Standard Deviation|Mean
2618553|NCT01970865|Secondary|Progression-Free Survival (PFS) (Phase 1)|PFS was defined as the time from the first dose of study treatment to the first documentation of objective disease progression or to death on study due to any cause, whichever came first. Results presented here were based on independent central review.|3 years|PFS analysis set included all participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.|||months||95% Confidence Interval|Median
2618526|NCT01970865|Secondary|Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-LC13 (Phase 1)|EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms, and improvement was defined as a decrease of at least 10 points, worsening was defined as an increase of at least 10 points. All scales which had not improved nor worsened were considered stable.|Baseline, Day 1 of Cycles 2-25, Day 1 of every other cycle after Cycle 25, end of treatment (up to 3 years)|Patient reported outcome (PRO) evaluable analysis set included all enrolled participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment.|||Participants|||Count of Participants
2618527|NCT01970865|Secondary|Number of Participants Who Improved, Worsened or Remained Stable in EORTC QLQ-C30 (Phase 1)|European Organisation for Research and Treatment of Cancer Core Quality of Life Questionaires (EORTC QLQ)-C30 (version 3.0) consists of 30 questions assessing 5 functional domains (physical, role, emotional, cognitive and social), global quality of life (QoL), disease/treatment related symptoms (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation and diarrhoea), and the perceived financial impact of disease. Each scale was transformed to a range of 0 to 100 using standard EORTC algorithm. For global QoL and functional scales, higher score indicate better performance, and improvement was defined as an increase of at least 10 points, worsening was defined as a decrease of at least 10 points. For symptom scales, higher score indicates worse symptoms, and improvement was defined as a decrease of at least 10 points, worsening was defined as an increase of at least 10 points. All scales which had not improved nor worsened were considered stable.|Baseline, Day 1 of Cycles 2-25, Day 1 of every other cycle after Cycle 25, end of treatment (up to 3 years)|Patient reported outcome (PRO) evaluable analysis set included all enrolled participants who received at least 1 dose of PF-06463922 and completed a baseline and at least 1 post-baseline PRO assessment.|||Participants|||Count of Participants
2618528|NCT01970865|Secondary|Number of Participants With ALK Mutation Based on Tumor Tissue Analysis (Phase 1)|Tumor tissues from archived tissue specimens and/or a de novo biopsy were analyzed for ALK kinase domain mutations. Number of participants with one or more ALK mutations is presented.|Screening|Tumor Tissue analysis set included all participants of the ITT analysis set who had at least 1 molecular tumor biomarker assayed from either the screening archival or screening de novo tumor biopsy sample (or both).|||Participants|||Count of Participants
2618529|NCT01970865|Secondary|Number of Participants With ALK Mutation Based on Plasma CNA Analysis (Phase 1)|Plasma circulating nucleic acid (CNA) samples were analyzed for ALK kinase domain mutations by digital polymerase chain reaction (PCR) BEAMing technology. Number of participants with one or more ALK mutations is presented.|Screening|CNA peripheral blood analysis set included all participants of the ITT analysis set who had at least 1 molecular biomarker assayed.|||Participants|||Count of Participants
2618530|NCT01970865|Secondary|Terminal Half-Life of Midazolam (Phase 1)|Terminal plasma half-life was defined as the time measured for the plasma concentration to decrease by one half, and calculated as loge(2)/kel, where kel was the rate constant for terminal phase. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available.|||hr||Standard Deviation|Mean
2618531|NCT01970865|Secondary|Apparent Volume of Distribution (Vz/F) of Midazolam (Phase 1)|Vz/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug, and calculated as dose/(AUCinf*kel), where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time, kel was the rate constant for terminal phase. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available.|||L||Geometric Coefficient of Variation|Geometric Mean
2618532|NCT01970865|Secondary|Apparent Oral Clearance (CL/F) of Midazolam (Phase 1)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose/AUCinf, where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2618533|NCT01970865|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Midazolam (Phase 1)|AUCinf was calculated as AUClast + (Clast*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the rate constant for terminal phase. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2618534|NCT01970865|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam (Phase 1)|Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of midazolam was determined using linear/log trapezoidal method. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2618535|NCT01970865|Secondary|Time for Cmax (Tmax) of Midazolam (Phase 1)|Tmax of midazolam was observed directly from data as time of first occurrence. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflect the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflect the PK assessment after multiple doses of PF-06463922 were administered.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for midazolam included all participants who received at least 1 dose of midazolam and for which at least 1 midazolam PK parameter of interest was available.|||hours||Full Range|Median
2618536|NCT01970865|Secondary|Maximum Observed Plasma Concentration (Cmax) of Midazolam (Phase 1)|Cmax of midazolam was observed directly from data. Only participants in 25 mg and 150 mg QD groups were given midazolam. Day -7 data reflected the PK assessment before administration of PF-06463922, and Cycle 1 Day 15 data reflected the PK assessment after multiple doses of PF-06463922 were administered.|Pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Day -7 and pre-dose, 0.5, 1, 2, 4, 6, 8, 9 and 24 hours post-dose on Cycle 1 Day 15|PK concentration analysis set for midazolam included all participants treated with midazolam who had at least 1 concentration of midazolam.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2618537|NCT01970865|Secondary|Percent of PF-06463922 Recovered Unchanged in Urine up to Dosing Interval (AEtau%) (Phase 1)|Dosing interval was 24 hours for QD dosing regimen. Aetau% was calculated as 100*Ae24/dose, where Ae24 was the cumulative amount of drug recovered unchanged in urine up to 24 hours post-dose.|0-4 hours, 4-12 hours and 12-24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. As planned, this parameter was only analyzed for 100 mg QD group.|||percentage of recovered PF-06463922||Standard Deviation|Mean
2618538|NCT01970865|Secondary|Renal Clearance (CLr) of PF-06463922 (Phase 1)|Renal clearance was calculated as Aetau/AUCtau, where Aetau was the cumulative amount of drug recovered unchanged in urine up to dosing interval tau (24 hours for QD dosing regimen), and AUCtau was the area under the plasma concentration-time profile from time 0 to time tau (24 hours for QD dosing regimen).|0-4 hours, 4-12 hours and 12-24 hours post-dose on Cycle 1 Day 15|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922. As planned, this parameter was only analyzed for 100 mg QD group.|||ml/hour||Geometric Coefficient of Variation|Geometric Mean
2618539|NCT01970865|Secondary|Steady State Accumulation Ratio (Rss) of PF-06463922 Following Multiple Oral Doses (Phase 1)|Rss was calculated as Day 15 AUCtau/Day -7 AUCinf, where AUCtau was the area under the plasma concentration-time profile from time 0 to time tau (12 and 24 hours for BID and QD dosing regimen, respectively), and AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups)|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||ratio||Standard Deviation|Mean
2618540|NCT01970865|Secondary|Terminal Half-Life of PF-06463922 Following Single Oral Doses (Phase 1)|Terminal plasma half-life was defined as the time measured for the plasma concentration to decrease by one half, and calculated as loge(2)/kel, where kel was the rate constant for terminal phase.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||hours (hr)||Standard Deviation|Mean
2618541|NCT01970865|Secondary|Observed Accumulation Ratio (Rac) of PF-06463922 Following Multiple Oral Doses (Phase 1)|Rac was calculated as Day 15 AUCtau/Day -7 AUCtau or Day 1 AUCtau, where AUCtau was the area under the plasma concentration-time profile from time 0 to time tau (12 and 24 hours for BID and QD dosing regimen, respectively).|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups)|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||ratio||Standard Deviation|Mean
2618542|NCT01970865|Secondary|Apparent Volume of Distribution (Vz/F) of PF-06463922 Following Single Oral Doses (Phase 1)|Vz/F was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug, and calculated as dose/(AUCinf*kel), where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time, kel was the rate constant for terminal phase.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||liters (L)||Geometric Coefficient of Variation|Geometric Mean
2618822|NCT01968954|Secondary|Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
2618543|NCT01970865|Secondary|Apparent Oral Clearance (CL/F) of PF-06463922 Following Multiple Oral Doses (Phase 1)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose/AUCinf, where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups)|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2618544|NCT01970865|Secondary|Apparent Oral Clearance (CL/F) of PF-06463922 Following Single Oral Doses (Phase 1)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as dose/AUCinf, where AUCinf was the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||liter/hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2618545|NCT01970865|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06463922 Following Single Oral Doses (Phase 1)|AUCinf was calculated as AUClast + (Clast*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the rate constant for terminal phase.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2618546|NCT01970865|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06463922 Following Multiple Oral Doses (Phase 1)|Tau refers to the dosing interval, and it equals to 12 or 24 hours for BID or QD dosing, respectively. AUCtau was determined using linear/log trapezoidal method.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups)|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2618547|NCT01970865|Secondary|Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of PF-06463922 Following Single Oral Doses (Phase 1)|Tau refers to the dosing interval, and it equals to 12 or 24 hours for BID or QD dosing, respectively. AUCtau was determined using linear/log trapezoidal method.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, and 24 hours post-dose on Day -7 for all other groups.|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2618548|NCT01970865|Secondary|Time for Cmax (Tmax) of PF-06463922 Following Multiple Oral Doses (Phase 1)|Tmax of PF-06463922 was observed directly from data as time of first occurrence.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups).|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||hours||Full Range|Median
2618549|NCT01970865|Secondary|Time for Cmax (Tmax) of PF-06463922 Following Single Oral Doses (Phase 1)|Tmax of PF-06463922 was observed directly from data as time of first occurrence.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.|PK parameter analysis set for PF-06463922 included all enrolled participants who received at least 1 dose of PF-06463922 and had sufficient information to estimate at least one of the PK parameters of interest for PF-06463922.|||hours||Full Range|Median
2618550|NCT01970865|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-06463922 Following Multiple Oral Doses (Phase 1)|Maximum Observed Plasma Concentration (Cmax) of PF-06463922 was observed directly from data.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24 hours post-dose on Cycle 1 Day 15 (24-hour samples not collected for BID groups).|PK concentration analysis set for PF-06463922 included all participants treated who had at least 1 concentration of PF-06463922.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2618551|NCT01970865|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-06463922 Following Single Oral Doses (Phase 1)|Maximum observed plasma concentration (Cmax) of PF-06463922 was observed directly from data.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9 and 24 hours post-dose on Cylce 1 Day 1 for 25 mg QD and 150 mg QD groups; pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 9, 24, 48, 72, 96 and 120 hours post-dose on Day -7 for all other groups.|PK concentration analysis set for PF-06463922 included all participants treated who had at least 1 concentration of PF-06463922.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2618552|NCT01970865|Secondary|Overall Survival (OS) (Phase 1)|OS was defined as the time from first dose to the date of death due to any cause. For participants still alive at the time of analysis, the OS time was censored on the last date the participants were known to be alive. Estimates of OS and its 95% confidence interval were determined using Kaplan-Meier method.|3 years|The intent-to-treat (ITT) analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.|||months||95% Confidence Interval|Median
2618640|NCT01970241|Primary|Mean POC Glucose Level Between Groups|Primary outcome measure was mean blood glucose levels measured pre-meal and at bedtime in study patients and controls for the duration of the intervention. Values shown are the overall mean point of care blood glucose.|Assessed from enrollment to discharge or enrollment to day five.||||mg/dl||Standard Deviation|Mean
2618554|NCT01970865|Secondary|Probability of First Event Being a Central Nervous System (CNS) Progression, Non CNS Progression, or Death (Phase 1)|"The probability of the first event being a CNS progression, a non-CNS progression, or death was evaluated with a competing risk approach by estimating cumulative incidence functions (range: 0-1) relative to the analysis set. The time to first event being a Competing Event (either CNS progression or non CNS progression or Death) was defined as time from first dose until the date of that specific event. Participants not known to have any of the Competing Events were censored on the date they were last assessed for disease status for PFS. Participants who presented one type of event were counted as a competing cause of failure for the analysis of other type of events. For each type of event, the cumulative incidence function corresponding to the nearest time point preceding 1 year is presented. The results are based on independent central review."|3 years|The intent-to-treat (ITT) analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.|||probability|||Number
2618555|NCT01970865|Secondary|Percentage of Participants Achieving Disease Control and Intracranial Disease Control at 12 Weeks (Phase 1)|Tumor response was evaluated according to RECIST version 1.1, and disease control was defined as confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD). Intracranial assessment was only performed for participants CNS metastases. Results presented here were based on independent central review.|12 weeks|The intent-to-treat (ITT) analysis set was used for overall response assessment, and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with CNS metastases in the ITT analysis set was used for intracranial response assessment.|||percentage of participants||95% Confidence Interval|Number
2618556|NCT01970865|Secondary|Duration of Response (DOR) and Intracranial DOR (Phase 1)|Duration of Response (DOR) was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first. DOR was only calculated for the subgroup of participants with a confirmed objective tumor response. Intracranial DOR was only calculated for participants with confirmed intracranial objective response. Results presented here were based on independent central review.|3 years|DOR analysis set included all ITT participants who had confirmed objective response; intracranial DOR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response.|||months||95% Confidence Interval|Median
2618557|NCT01970865|Secondary|Time to Tumor Response (TTR) and Intracranial TTR (Phase 1)|Time to tumor response (TTR) was defined as the time from the first dose of study treatment to the first documentation of objective tumor response (CR or PR). For participants whose objective response proceeded from PR to CR, the onset of PR was taken as the onset of response. TTR was only calculated for the subgroup of participants with a confirmed objective tumor response. Intracranial TTR was only calculated for participants with confirmed intracranial objective response. Results presented here were based on independent central review.|3 years|TTR analysis set included all ITT participants who had confirmed objective response; intracranial TTR analysis set included all ITT participants who had CNS metastases and achieved confirmed intracranial objective response.|||months||Full Range|Median
2618558|NCT01970865|Secondary|Percentage of Participants With Overall and Intracranial Objective Response (Phase 1)|Objective response (OR) refers to confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Intracranial OR refers to confirmed CR or PR considering only lesions within brain. Results presented here were based on independent central review.|3 years|The intent-to-treat (ITT) analysis set was used for overall response assessment, and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with CNS metastases in the ITT analysis set was used for intracranial response assessment.|||percentage of participants||95% Confidence Interval|Number
2618559|NCT01970865|Primary|Percentage of Participants With Overall and Intracranial Objective Response (Phase 2)|Objective response (OR) refers to confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Intracranial OR refers to confirmed CR or PR considering only lesions within brain. Results presented here were based on independent central review.|3 years|The intent-to-treat (ITT) analysis set was used for overall response assessment, and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with central nervous system (CNS) metastases in the ITT analysis set were used for intracranial response assessment.|||percentage of participants||95% Confidence Interval|Number
2618560|NCT01970865|Primary|Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1|DLT was defined as any of the following adverse events (AEs) attributable to PF-06463922: (1) hematologic: grade 4 neutropenia for >7 days; febrile neutropenia; grade >=3 neutropenic infection; grade >=3 thrombocytopenia with bleeding; grade 4 thrombocytopenia; (2) non-hematologic: grade >=3 pancreatitis; grade >=3 toxicities (excluding grade >=3 laboratory abnormalities not requiring dose modifications) persisting after optimal treatment with standard medical therapy; symptomatic grade >=3 QTc prolongation, or asymptomatic grade >=3 prolongation that had been confirmed by repeat testing and re-evaluation by a qualified person, and persisted after correction of reversible causes; >=20% decrease from baseline in left ventricular ejection fraction (LVEF); (3) other: failure to deliver at least 16 out of the 21 prescribed daily total doses due to toxicities attributable to study drug; failure to restart dosing after 21 days (1 cycle) delay due to toxicities attributable to study drug.|Cycle 1 (21 days)|Maximum Tolerated Dose (MTD) evaluable population included all enrolled participants who received at least 75% of the planned PF-06463922 doses in Cycle 1. Participants who received less than 75% of the planned PF-06463922 doses in Cycle 1 due to DLT were also considered evaluable for MTD.|||Participants|||Count of Participants
2618561|NCT01970787|Secondary|Progression of HSIL to Cancer|Histologic progression of HSIL to cancer as measured in biopsies read at the central pathology lab. Data not collected and could not be analyzed.|12 months|||||||
2618562|NCT01970787|Secondary|Adverse Events|Any related adverse event occuring in patients enrolled in this study. Event type and relationship to the device or procedure will be measured.|12 months||||participants|||Number
2618641|NCT01969916|Primary|Number of Participants With Detected Stress-induced Perfusion Abnormalities by 3D Analysis of MDCT Images|Perfusion defect on stress CT images obtained at peak effect of Regadenoson, in the presence of coronary stenosis >50%.|At least 1 year||||Participants|||Count of Participants
2618563|NCT01970787|Secondary|Tolerability|"Subject tolerability of the RFA procedure as measured by severity. Mild: Awareness of signs and symptoms, but easily tolerated; are of a minor irritant type; causing no loss of time from normal activities; symptoms would not require medication or a medical intervention; asymptomatic lab findings; marginal clinical relevance; signs and symptoms are transient.~Moderate: Discomfort severe enough to cause interference with usual activities; minimal intervention.~Severe: Incapacitating with inability to do work or usual activities; signs and symptoms may be of systemic nature or require medical evaluation or treatment."|12 months||||participants|||Number
2618564|NCT01970787|Secondary|Feasibility and Ease of Technique|"Technical feasibility of applying RFA to the anal canal. Physician's assessment of ablation as optimal (complete ablation) versus sub-optimal (incomplete ablation)in the affected area in the anal canal.~Data not collected and could not be analyzed"|12 months|||||||
2618565|NCT01970787|Primary|Clearance of Anal HSIL (High Grade Squamous Intraepithelial Lesion (HSIL)|Participants with histologic clearance of anal HSIL within the ETZ (eligible treatment zone) at 12 months from first RFA treatment|12 months||||participants w histological clearance|||Number
2618566|NCT01970592|Secondary|Muscle Strength|The strength of the paretic lower leg muscles will be measured by asking the participants to contract their muscles as forcefully as possible. Testing will be conducted on a specialized machine called an isokinetic dynamometer. This testing is designed to assess the ability to generate muscle power. Before testing the participants will be asked to perform 5 minutes of low intensity cycling. Strength testing will include movements at the hip, knee and ankle in both legs.|8 weeks|Individuals completing POWER training|||foot pounds||Standard Deviation|Mean
2618567|NCT01970592|Primary|Gait Speed|"The speed the subject chooses to walk when instructed to walk at their comfortable speed"|8 weeks|Individuals completing POWER training|||meters per second||Standard Deviation|Mean
2618568|NCT01970540|Secondary|Overall Survival|Overall survival (OS) is defined as the time from the date of first infusion of study treatment to the date of death (due to any cause). Patients with no documented death were censored at the last date they are known to be alive|Time from the date of first administration to the date of death (of any cause), assessed up to 72 months|Cohort A: Events: 15 (20.5%); Cohort B: SCLC: Events: 22 (78.6%); Cohort B: Endometrial Events: 11 (57.9%)|||months||95% Confidence Interval|Median
2618569|NCT01970540|Secondary|Progression-free Survival|Progression-free survival (PFS) is defined as the time from the date of first infusion of study treatment to the date of progression or death (due to any cause). If progression or death has not occurred at the time of the analysis, the PFS was censored on the date of last tumor evaluation.|Time from the date of first administration to the date of PD or death (of any cause), whichever came first, assessed up to 72 months|Cohort A: 1 patient was not evaluable: extensive bone marrow involvement Events: 66 (91.7%) Cohort B: SCLC Events: 28 (100.0%) Cohort B: Endometrial: Events: 14 (73.7%)|||months||95% Confidence Interval|Median
2618570|NCT01970540|Secondary|Duration of Response|The duration of overall response was measured from the time measurement criteria are met for complete response (CR)/ PR, whichever is first recorded, until the first date in which progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started) or the date of death. In absence of disease progression or death, the duration of response was censored on the date of last tumor evaluation.|Time from the time measurement criteria are met for complete response, whichever is first recorded, until the first date in which progressive disease is objectively documented or the date of death, assessed up to 72 months|Cohort A: 26 patients showed response to treatment Events: 26 (100.0%) Cohort B SCLC: 10 patients showed response to treatment Events: 10 (100.0%) Cohort B: Endometrial: 8 patients showed response to treatment Events: 4 (50.0%)|||months||95% Confidence Interval|Median
2618571|NCT01970540|Secondary|Best Overall Tumor Response|Tumor response was evaluated according to the RECIST v.1.1 for target lesions and assessed by computed tomography (CT) scans or magnetic resonance imagings (MRIs): Progressive disease (PD) is declared when there is an increase in sum of target disease ≥ 20%, stable diease (SD) when the change is > -30% and ≤ 20%, partial response (PR) when there is a decrease in sum of target disease ≥ 30%, and complete response (CR) when all lesions have disappeared or all lesions have disapeared and all nodal disease is < 10 mm each.|Tumor assessments were done every six weeks up to study completion|Cohort A: 1 patient of 73 was not evaluable: extensive bone marrow involvement|||Participants|||Count of Participants
2618572|NCT01970540|Primary|Number of Participants With Dose-limiting Toxicities|DLT,dose-limiting toxicity Patients enrolled into this study were originally not allowed to receive primary G-CSF prophylaxis. However, the finding of dose-limiting febrile neutropenia in two patients treated at dose level I in the present study (see below) suggested that increasing doses of the DOX/PM01183 combination might require primary G-CSF prophylaxis to decrease the risk of febrile neutropenia. Therefore, a separate dose escalation was established to define the MTD and the RD of the DOX/PM01183 combination with compulsory primary G-CSF prophylaxis.|During the first cycle of treatment, up to 28 days|Patients evaluable for the primary endpoint (evaluable for DLT): 5 patients were not evaluable in Cohort A and 1 patient in Cohort B.|||Participants|||Count of Participants
2618573|NCT01970540|Primary|Recommended Dose (RD)|The DL immediately below the MTD, or DL4 if the MTD is not yet defined during dose escalation before the last DL (i.e., DL4) is reached, was to be initially expanded up to a minimum of nine evaluable patients. If less than three among the first nine evaluable patients treated within the expansion cohort experience a DLT during Cycle 1, this DL will be the RD.|During the first cycle of treatment, up to 28 days|Fifty-seven of the 61 patients treated in this cohort without primary G-CSF prophylaxis were evaluable for DLTs|||DOX mg/m2 PM01183 mg FD|||Number
2618574|NCT01970540|Primary|Maximum Tolerated Dose (MTD)|A minimum of three patients will be included at each DL. If no patients experience a DLT during Cycle 1, the dose will be escalated. If one of three patients experiences a DLT, three additional patients will be included at that level. If >1 evaluable patient during dose escalation at a given DL experience a DLT during Cycle 1, that DL will be considered the MTD and dose escalation will be terminated, except if all DLTs are related to neutropenia exclusively, in which case dose escalation may be resumed as originally planned in a new cohort of patients but with compulsory primary G-CSF prophylaxis.|During the first cycle of treatment, up to 28 days|Fifty-seven of the 61 patients treated in this cohort without primary G-CSF prophylaxis were evaluable for DLTs Eleven of the 12 patients treated with primary G-CSF prophylaxis in this cohort were evaluable for DLTs.|||DOX mg/m2 PM01183 mg FD|||Number
2618575|NCT01970527|Primary|Overall Survival|Will be estimated by the Kaplan-Meier method separately for previously untreated and previously treated metastatic patients who were treated at the MTD.|Time from first day of radiotherapy to death due to any cause or last patient contact alive, assessed at 12 months|Arms were stratified during tx for safety reasons, but the stated objective to calculate response rate per strata was re-assessed. Due to low accrual per-strata calculations lack the statistical power to draw robust conclusions. Results were not stratified during the statistical analysis of the study data and are reported.|||Days||Standard Deviation|Median
2618576|NCT01970527|Primary|Late Toxicities, Graded According to the Radiation Therapy Oncology Group/European Organization for Research, the Treatment of Cancer Late Morbidity Scoring System, and the Common Terminology Criteria for Adverse Events Version 4.0|Defined generally as an adverse event associated with the treatment which occurs beyond 30 days after last injection (i.e., adverse events which are observed months after treatment are most likely associated with SBRT). All dose-limiting toxicities and late toxicities will be graded and tabled by lesion site stratum and SBRT fraction dose level. Toxicity attribution to either SBRT or ipilimumab will be described if possible.|Up to 3 years||||Participants|||Count of Participants
2618577|NCT01970527|Primary|Immune-related Progression-free Survival (irPFS)|"irPFS will be estimated by the Kaplan-Meier method separately for previously untreated and previously treated metastatic patients who were treated at the MTD..~For some patients no scans were available for irRECIST reads, in which case change of management was determined to be the point of progression."|Time from first day of radiotherapy to first documented immune-related progressive disease, death due to any cause or last patient contact alive and progression-free, assessed at 6 months|Arms were stratified during tx for safety reasons, but the stated objective to calculate response rate per strata was re-assessed. Due to low accrual per-strata calculations lack the statistical power to draw robust conclusions. Results were not stratified during the statistical analysis of the study data and are reported as such here.|||Days||Standard Deviation|Median
2618578|NCT01970527|Primary|Immune-related Clinical Response, Defined as Proportion of Patients Treated at the Maximum-tolerated Dose (MTD) Who Achieve Either a Complete or Partial Immune-related Response|Scored on a non-index lesion using immune-related response criteria according to immune-related Response Evaluation Criteria in Solid Tumors version 1.1. The number of immune-related responses will be tabled by stratum and SBRT fraction dose level. At the MTD, the immune-related response rate and 95% exact confidence interval will be estimated separately for previously untreated and previously treated metastatic patients.|Up to 60 days after last ipilimumab injection|Arms were stratified during tx for safety reasons, but the stated objective to calculate response rate per strata was re-assessed. Due to low accrual per-strata calculations lack the statistical power to draw robust conclusions. Results were not stratified during the statistical analysis of the study data and are reported as such here.|||Participants|||Count of Participants
2618579|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 100 Response at Week 50|A PASI 100 response is a 100% improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 50|This analysis was performed in the re-randomized analysis set with available data.|||percentage of participants|||Number
2618580|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 100 Response at Week 32|A PASI 100 response is a 100% improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 32|This analysis was performed in the re-randomized analysis set with available data|||percentage of participants|||Number
2618581|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 100 Response at Week 16|A PASI 100 response is a 100% improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.|||percentage of participants|||Number
2618582|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 90 Response at Week 50|"A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and Week 50|This analysis was performed in the re-randomized analysis set with available data.|||percentage of participants|||Number
2618583|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 90 Response at Week 32|"A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and Week 32|This analysis was performed in the re-randomized analysis set with available data|||percentage of participants|||Number
2618584|NCT01970488|Post-Hoc|Percentage of Participants With a PASI 90 Response at Week 16|A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.|||percentage of participants|||Number
2618585|NCT01970488|Secondary|Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab|"Two validated assays were used to detect the presence of anti-drug antibodies. Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against ABP 501 and adalimumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501 or adalimumab (Neutralizing Antibody Assay).~Developing antibody incidence is defined as a negative or no antibody result at baseline and a positive antibody result at a post-baseline time point."|For 16 weeks in Part 1 and for 52 weeks for participants who were re-randomized in Part 2.|Results are reported for the anti-drug antibody analysis set (defined as the subset of participants in the Safety Analysis Set who had at least 1 evaluable antibody test) from Baseline to Week 16 for all randomized participants, and from baseline to Week 52 for participants who were re-randomized.|||percentage of participants|||Number
2618586|NCT01970488|Secondary|Number of Participants With Adverse Events|"The Investigator assessed whether each adverse event (AE) was possibly related to the investigational product. AEs were graded for severity according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03.~A serious AE is defined as an AE that meets at least 1 of the following serious criteria:~fatal~life threatening~requires inpatient hospitalization or prolongation of existing hospitalization~results in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event. Results are reported from Day 1 to week 16 for the Part 1 ABP 501 and Adalimumab groups, and from post week 16 to the end of study (week 52) for the Part 2 ABP 501/ABP 501, Adalimumab/Adalimumab and Adalimumab/ABP 501 groups."|From first dose of study drug until 28 days after the last dose. Treatment was for 16 weeks in Part 1 and 32 weeks in Part 2.|The safety analysis set includes all randomized participants who received at least 1 dose of study drug, based on actual treatment received.|||participants|||Number
2618587|NCT01970488|Secondary|Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50|"A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface.~Change from baseline is calculated as (value at post-baseline visit - value at baseline).~A decrease from Baseline (negative value) indicates improvement."|Baseline and week 50|This analysis was performed in the re-randomized analysis set with available data|||percentage of BSA||Standard Deviation|Mean
2618588|NCT01970488|Secondary|Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32|"A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface.~Change from baseline is calculated as (value at post-baseline visit - value at baseline).~A decrease from Baseline (negative value) indicates improvement."|Baseline and week 32|This analysis was performed in the re-randomized analysis set with available data|||percentage of BSA||Standard Deviation|Mean
2618589|NCT01970488|Secondary|Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16|"A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface.~Change from baseline is calculated as (value at post-baseline visit - value at baseline).~A decrease from baseline (negative value) indicates improvement."|Baseline and Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.|||percentage of BSA||Standard Deviation|Mean
2618590|NCT01970488|Secondary|Percentage of Participants With a sPGA Response at Week 50|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 50|This analysis was performed in the re-randomized analysis set with available data.|||percentage of participants|||Number
2618591|NCT01970488|Secondary|Percentage of Participants With a sPGA Response at Week 32|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 32|This analysis was performed in the re-randomized analysis set with available data|||percentage of participants|||Number
2618592|NCT01970488|Secondary|Percentage of Participants With a Static Physician's Global Assessment (sPGA) Response at Week 16|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.|||percentage of participants|||Number
2618593|NCT01970488|Secondary|Percent Improvement From Baseline in PASI at Week 50|"The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.~Percent improvement from baseline is calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline)."|Baseline and week 50|This analysis was performed in the re-randomized analysis set with available data|||percent change||Standard Deviation|Mean
2618594|NCT01970488|Secondary|Percent Improvement From Baseline in PASI at Week 32|"The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.~Percent improvement from baseline is calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline)."|Baseline and week 32|This analysis was performed in the re-randomized analysis set with available data|||percent change||Standard Deviation|Mean
2624503|NCT01923480|Secondary|Plasma Concentration of Methionine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
2618595|NCT01970488|Secondary|Percentage of Participants With a PASI 75 Response at Week 50|"A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and week 50|This analysis was performed in the re-randomized analysis set which includes all participants who were re-randomized at Week 16 in the study. Only participants with available data at week 50 are included.|||percentage of participants|||Number
2618596|NCT01970488|Secondary|Percentage of Participants With a PASI 75 Response at Week 32|"A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score.~The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis."|Baseline and week 32|This analysis was performed in the re-randomized analysis set which includes all participants who were re-randomized at Week 16 in the study. Only participants with available data at week 32 are included.|||percentage of participants|||Number
2618597|NCT01970488|Secondary|Percentage of Participants With a PASI 75 Response at Week 16|A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Week 16|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value.|||percentage of participants|||Number
2618598|NCT01970488|Primary|Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16|"The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.~Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline)."|Baseline and Week 16|This analysis was performed using the full analysis set which includes all participants initially randomized in the study. Last observation carried forward (LOCF) imputation was used for participants with at least one post-baseline value.|||percent change||Standard Deviation|Mean
2618599|NCT01970475|Secondary|Percentage of Participants Who Developed Antibodies to ABP 501 or Adalimumab|"Two validated assays were used to detect the presence of anti-drug antibodies. Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against ABP 501 and adalimumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501 or adalimumab (Neutralizing Antibody Assay).~Developing antibody incidence is defined as a negative or no antibody result at baseline and a positive antibody result at a post-baseline time point."|Up to week 26|Participants with at least 1 evaluable antibody test result (to either ABP 501 or adalimumab)|||percentage of participants|||Number
2618600|NCT01970475|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale:~1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal. A treatment-related AE is defined as an event where the answer to the question is there a reasonable possibility that the event may have been caused by the Investigational Medicinal Product was yes.~A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria:~fatal~life threatening (places the subject at immediate risk of death)~requires inpatient hospitalization or prolongation of existing hospitalization~results in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event."|From the time of first treatment up to 28 days following the last dose of study treatment; 26 weeks.|The safety analysis set (all participants who received at least 1 dose of study drug)|||participants|||Number
2618601|NCT01970475|Secondary|Percentage of Participants With an ACR70 Response at Week 24|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 70% improvement in tender joint count;~≥ 70% improvement in swollen joint count; and~≥ 70% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-Reactive Protein level."|Baseline and Week 24|Full analysis set with available data at week 24|||percentage of participants|||Number
2618602|NCT01970475|Secondary|Percentage of Participants With an ACR50 Response at Week 24|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-Reactive Protein level."|Baseline and week 24|Full analysis set with available data at week 24|||percentage of participants|||Number
2618638|NCT01970241|Other Pre-specified|Percentage of Point of Care Glucose Measurements Between 70 - 180 mg/dL|Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements between 70 - 180 mg/dl.|From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.||||Percentage of total measurements of gluc|||Number
2618603|NCT01970475|Secondary|Percentage of Participants With an ACR20 Response at Week 2 and Week 8|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-Reactive Protein level."|Baseline, week 2 and week 8|Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value (indicated by n).|||percentage of participants|||Number
2618604|NCT01970475|Secondary|Change From Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)|"The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP) level~Patient's global assessment of disease activity assessed on a score from 0 to 100 transformed from the result measured on a horizontal scale from 0 (no RA activity at all) to 10 (worst RA activity imaginable).~The DAS28-CRP score ranges from approximately zero to ten. Higher DAS28-CRP scores indicate higher disease activity.~A repeated measures analysis with the DAS28-CRP change from baseline as the response and the stratification variables, visit, treatment, treatment-by-visit interaction and the baseline DAS28-CRP measurement as predictors in the model was performed."|Baseline and weeks 2, 4, 8, 12, 18, and 24|Full analysis set with available data at each time point|||units on a scale||Standard Deviation|Least Squares Mean
2618605|NCT01970475|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24|"A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);~Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);~Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-Reactive Protein level."|Baseline and Week 24|The full analysis set (all randomized participants); missing values were imputed using the last observation carried forward (LOCF) method for participants with at least 1 postbaseline value.|||percentage of participants|||Number
2618606|NCT01970462|Other Pre-specified|Hypoglycemia|Number of subjects with glucose <70 mg/dl following time of discharge to 6 weeks.|6 weeks|The study was discontinued early and the group assignment was not available from the pharmacy for 3 subjects. therefore we are unable to provide group level data for the outcomes. There was no hypoglycemia reported in any of the 5 subjects for whom data were available at the 6 week timepoint.||||||
2618607|NCT01970462|Other Pre-specified|Adherence|adherence defined as 80% of all Sitagliptin doses respectively taken in previous week|6 weeks|The study was discontinued early and the group assignment was not available from the pharmacy for 3 subjects. therefore we are unable to provide group level data for the outcomes. Among the 5 subjects for whom data were available, 100% were adherent.||||||
2618608|NCT01970462|Other Pre-specified|Self Monitored Blood Glucose|Mean blood glucose at week 2|2 weeks|The study was discontinued early and the group assignment was not available from the pharmacy for 3 subjects. therefore we are unable to provide group level data for the outcomes. Among the 5 subjects for whom data were available the value was 130, 134.6, 96.5, 132, 98 mg/dl||||||
2618609|NCT01970462|Primary|Difference in Fasting Glucose|Difference in mean fasting glucose at 6 weeks post-discharge.|6 weeks|The study was discontinued early and the group assignment was not available from the pharmacy for 3 subjects. Therefore we are unable to provide group level data for the outcomes. Among the 4 subjects for whom data was available, the fasting 6 week glucose value was 158, 114, 83, 237 mg/dl.||||||
2618610|NCT01970397|Secondary|Subject's Global Assessment of Change in Appearance of Perioral Lines|The participant evaluated the change in the appearance of their perioral lines (the lines that radiate outward from the edges of the upper and lower lips) using a 7-point scale where: 1 = Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse.|Baseline, Days 7, 14, Days 7, 14 after touch-up, Months 1, 3 and 6|Participants from the Intent-to-treat population, all randomized treated participants, with data available at the given time-point.|||units on a scale||95% Confidence Interval|Mean
2618611|NCT01970397|Secondary|Participant Assessed Procedural and Post-Procedural Pain Levels|The participant assessed procedural and post-procedural pain using an 11-point scale where: 0=no pain to 10=worst pain imaginable.|During injection, immediately following injection, 15, 30, and 45 min post-injection|Intent-to-treat population included all randomized and treated participants.|||units on a scale||95% Confidence Interval|Mean
2618612|NCT01970397|Primary|Percentage of Participants With at Least a 1 Point Improvement From Baseline on the Perioral Lines Severity Scale (POLSS)|The investigator evaluated the severity of the participant's upper and low lip at Baseline (Pre-treatment) to Month 6 using the 4-point POLSS where None=No lines, Mild=Few, shallow lines, Moderate=Some, moderate lines or Severe=Many, deep lines or crevices. The percentage of participants with at least a 1 Point Improvement is reported.|Baseline, Month 6|Participants from the Intent-to-treat population, all randomized treated participants, with data available for analysis at Month 6.|||percentage of participants|||Number
2618613|NCT01970371|Secondary|Plasma Pharmacokinetics (PK): Minimum Observed Plasma Drug Concentration (Cmin)|PK specimens were collected on Days 1 and 4 using a sparse sampling scheme, and concentration-time data from these PK specimens were pooled with data from specimens collected for TDM. The pooled data were analyzed by population PK modeling, which described PK over the entire course of plazomicin treatment. The protocol allowed dose adjustments based on creatinine clearance; therefore, various dose regimens were used in the study, including regimens with dosing intervals of 12, 24, and 48 hours. To enable a combined summation of exposures across dose regimens, PK exposure parameters for the study were summarized for the first 48 hours of treatment. Thus, while exposures are summarized for the first 48 hours, the reported results considered patient data over the course of plazomicin treatment.|48 hours|PK population included all patients who had received at least 1 dose of plazomicin and had at least 1 quantifiable plazomicin plasma concentration available for analysis.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
2618614|NCT01970371|Secondary|Plasma Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax)|PK specimens were collected on Days 1 and 4 using a sparse sampling scheme, and concentration-time data from these PK specimens were pooled with data from specimens collected for TDM. The pooled data were analyzed by population PK modeling, which described PK over the entire course of plazomicin treatment. The protocol allowed dose adjustments based on creatinine clearance; therefore, various dose regimens were used in the study, including regimens with dosing intervals of 12, 24, and 48 hours. To enable a combined summation of exposures across dose regimens, PK exposure parameters for the study were summarized for the first 48 hours of treatment. Thus, while exposures are summarized for the first 48 hours, the reported results considered patient data over the course of plazomicin treatment.|48 hours|PK population included all patients who had received at least 1 dose of plazomicin and had at least 1 quantifiable plazomicin plasma concentration available for analysis.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
2618615|NCT01970371|Secondary|Plasma Pharmacokinetics (PK): Area Under the Curve From 0 to 24 Hours (AUC 0-24h)|PK specimens were collected on Days 1 and 4 using a sparse sampling scheme, and concentration-time data from these PK specimens were pooled with data from specimens collected for TDM. The pooled data were analyzed by population PK modeling, which described PK over the entire course of plazomicin treatment. The protocol allowed dose adjustments based on creatinine clearance; therefore, various dose regimens were used in the study, including regimens with dosing intervals of 12, 24, and 48 hours. To enable a combined summation of exposures across dose regimens, PK exposure parameters for the study were summarized for the first 48 hours of treatment. Thus, while exposures are summarized for the first 48 hours, the reported results considered patient data over the course of plazomicin treatment.|48 hours|PK population included all patients who had received at least 1 dose of plazomicin and had at least 1 quantifiable plazomicin plasma concentration available for analysis.|||mg*h/L (millgrams times hours per liter)||Geometric Coefficient of Variation|Geometric Mean
2618616|NCT01970371|Secondary|Percentage of Patients With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered to be drug related. An AE (also referred to as an adverse experience) can be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, and it does not imply any judgment about causality. Adverse events also include the exacerbation or worsening of a condition present at screening other than the index infection for which the patient was enrolled in the study. A TEAE is any AE that newly appeared, increased in frequency, or worsened in severity following initiation of study drug. The safety population included all randomized patients who received any amount of study drug.|Up to Day 67|The safety population included all randomized patients who received any amount of study drug.|||percentage of patients|||Number
2618617|NCT01970371|Secondary|Percentage of Patients With Dose Adjustment Due to Therapeutic Drug Management (TDM)|"After the initial plazomicin dose, subsequent doses were adjusted, as directed, with the use of TDM on Day 1, 4, and 8 as needed.~Note: Although it is generally expected that results for primary and secondary endpoints will be presented for all arms included at baseline, results for Cohort 1: Colistin are not presented here as TDM collection does not apply to and was not collected for patients in the colistin arm, as only plazomicin levels were measured."|Up to Day 14|The safety population included all randomized patients who received any amount of study drug.|||percentage of patients|||Number
2618618|NCT01970371|Secondary|Percentage of Patients With ACM at Day 14 in the mMITT Population in Cohort 1|"ACM at Day 14 was defined as a confirmed date of death within 14 days of the first dose of study drug, irrespective of causality.~Note: Although it is generally expected that results for primary and secondary endpoints will be presented for all arms included at baseline, results for Cohort 2 are not presented here as this Cohort was not part of the primary or key secondary endpoints per the protocol and SAP."|Day 14|The mMITT population was a subset of MITT population and included all patients who received ≥1 dose of study drug and had a CRE pathogen. CRE=meropenem MIC of ≥4 μg/mL or meropenem MIC=2 μg/mL and disk diffusion results (≤19 mm) indicating meropenem resistance.|||percentage of patients|||Number
2618619|NCT01970371|Secondary|Time to Death Through Day 28 in the mMITT Population in Cohort 1|"Time to death through Day 28 is defined as days from first dose of study drug to death from any cause on or before Day 28. Patients who were alive at Day 28 were censored on Day 28. Any patient whose survival status was not known at Day 28 was censored on the last known date alive.~Note: Although it is generally expected that results for primary and secondary endpoints will be presented for all arms included at baseline, results for Cohort 2 are not presented here as this Cohort was not part of the primary or key secondary endpoints per the protocol and SAP."|Up to Day 28|The mMITT population included all patients who received at least 1 dose of study drug and had a CRE pathogen. CRE=meropenem MIC of ≥4 μg/mL or meropenem MIC=2 μg/mL and disk diffusion results (≤19 mm) indicating meropenem resistance.|||percentage of patients|||Number
2618620|NCT01970371|Secondary|Percentage of Patients With Adjudicated Clinical Cure at the Test of Cure (TOC) Visit in the mMITT Population in Cohort 1|"Clinical response (CR) was assessed at end of treatment (EOT) in all patients and at TOC for those who were a clinical cure or had an indeterminate outcome at the most recent visit. Assessment of CR at TOC was not needed for those who were a clinical failure at an earlier visit. Clinical outcomes at both EOT and TOC were independently adjudicated by an external committee. The assessment was confounded by comorbidities and the occurrence of additional infections; thus, adjudicating CR of the baseline CRE infection was influenced by confounding signs and symptoms of unrelated infections or conditions. The difficulty assessing CR supports greater reliance on the more objective mortality-based primary endpoint in these patients.~Note: Although it is generally expected that results for primary and secondary endpoints will be presented for all arms included at baseline, results for Cohort 2 are not presented here as this Cohort was not part of the endpoints per the protocol and SAP."|Up to TOC (Day 23)|The mMITT population was a subset of MITT population and included all patients who received at least 1 dose of study drug and had a CRE pathogen. CRE=meropenem MIC of ≥4 μg/mL or meropenem MIC=2 μ/mL and disk diffusion results (≤19 mm) indicating meropenem resistance.|||percentage of patients|||Number
2618639|NCT01970241|Secondary|Episodes of Hypoglycemia Between NPH and Control Groups|Hypoglycemia was defined as point of care glucose less than 70 mg/dL.|Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown represent cumulative episodes of hypoglycemia per group.||||Hypoglycemic episodes.|||Number
2618621|NCT01970371|Secondary|Percentage of Patients With ACM at Day 28 in the mMITT Population in Cohort 1|"ACM at Day 28: confirmed date of death within 28 days of the first dose of study drug, irrespective of causality.~Note: Although it is generally expected that results for primary and secondary endpoints will be presented for all arms included at baseline, results for Cohort 2 are not presented here as this Cohort was not part of the primary or key secondary endpoints per the protocol and SAP."|Up to Day 28|The mMITT population was a subset of MITT population and included all patients who received at least 1 dose of study drug and had a CRE pathogen. CRE=meropenem MIC of ≥4 μg/mL or meropenem MIC=2 μg/mL and disk diffusion results (≤19 mm) indicating meropenem resistance.|||percentage of patients|||Number
2618622|NCT01970371|Primary|Percentage of Patients With All Cause Mortality (ACM) at Day 28 or Significant Disease-Related Complication (SDRC) in the Microbiological Modified Intent to Treat (mMITT) Population in Cohort 1|"ACM at Day 28: confirmed date of death within 28 days of the first dose of study drug, irrespective of causality. SDRCs for all patients: presence of 1 or more of the following complications within 7 days of randomization: new or worsening acute respiratory distress syndrome (ARDS), new lung abscess, new empyema, new onset of septic shock, new carbapenem-resistant Enterobacteriaceae (CRE) (HABP/VABP patients only); persistent bacteremia on study Day ≥5 (BSI patients only).~Note: Although it is generally expected that results for primary and secondary endpoints will be presented for all arms included at baseline, results for Cohort 2 are not presented here as this Cohort was not part of the primary or key secondary endpoints per the protocol and statistical analysis plan (SAP)."|Up to Day 28 for ACM, up to 7 Days for SDRCs in all patients, on or after Day 5 for BSI patients only.|The mMITT population was a subset of the MITT population and included all patients who received ≥1 dose of study drug and had a CRE pathogen. CRE=meropenem minimum inhibitory concentration (MIC) of ≥4 micrograms per milliliter (μg/mL) or meropenem MIC=2 μg/mL and disk diffusion results (≤19 millimetres [mm]) indicating meropenem resistance.|||percentage of patients|||Number
2618623|NCT01970241|Other Pre-specified|Correlation of C-peptide With Length of Stay||Measured once at the time of enrollment||||correlation coefficient|||Number
2618624|NCT01970241|Other Pre-specified|Correlation of C-peptide With Plasma Glucose||Measured the time of enrollment||||correlation coefficient|||Number
2618625|NCT01970241|Other Pre-specified|Correlation of C-peptide With Duration of Diabetes||Measured once at the time of enrollment||||correlation coefficient|||Number
2618626|NCT01970241|Other Pre-specified|Correlation of C-peptide With Hemoglobin A1c||Measured once at the time of enrollment||||correlation coefficient|||Number
2618627|NCT01970241|Other Pre-specified|Correlation of C-peptide With ALT||Measured once at the time of enrollment||||correlation coefficient|||Number
2618628|NCT01970241|Other Pre-specified|Correlation of C-peptide With Serum Creatinine||Measured once at the time of enrollment||||correlation coefficient|||Number
2618629|NCT01970241|Other Pre-specified|Correlation of C-peptide With eGFR||Measured once at the time of enrollment||||correlation coefficient|||Number
2618630|NCT01970241|Other Pre-specified|Correlation of C-peptide With BMI||Measured once at the time of enrollment||||correlation coefficient|||Number
2618631|NCT01970241|Other Pre-specified|Correlation of C-peptide With Age||plasma C-peptide was measured once at the time of enrollment||||correlation coefficient|||Number
2618632|NCT01970241|Other Pre-specified|Mean Point of Care (POC) Glucose Level in Both Groups.|The overall mean point of care glucose levels in the NPH group and control group on the last day of the study.|On day 5 or last day of hospitalization (if less than 5 days) glucose level as measured by point of care glucose before breakfast, lunch, dinner and bed time.|Point of care glucose checked before breakfast, lunch, dinner, and bed time on day 5 of study enrollment. The numbers indicated below show the mean point of care (POC) glucose readings in the two groups on the last day of the study.|||mg/dL (mean values)||95% Confidence Interval|Mean
2618633|NCT01970241|Other Pre-specified|Mean Point of Care (POC) Glucose Level in Both Groups.|The overall mean point of care glucose levels in the NPH group and control group on the first day of the study.|On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time.|Point of care glucose checked before breakfast, lunch, dinner, and bed time on day 1 of study enrollment. The numbers indicated below show the mean point of care (POC) glucose readings in the two groups on the first day of the study.|||mg/dL (mean values)||95% Confidence Interval|Mean
2618634|NCT01970241|Other Pre-specified|Difference in Length of Stay Between NPH and Control Group|Time difference of hospitalization between the NPH and control groups.|Measured from the day of admission till the day of discharge|Difference in mean length of stay between NPH group and usual care group|||Days||Full Range|Mean
2618635|NCT01970241|Other Pre-specified|Incidence of Hyperglycemia Defined as Point of Care Glucose > 400 mg/dL|Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements > 400 mg/dL.|From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.||||Percentage of total measurements|||Number
2618636|NCT01970241|Other Pre-specified|Incidence of Hyperglycemia Defined as Point of Care Glucose 300 - 400 mg/dl|Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements 300 - 400 mg/dl.|From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.||||Percentage of total measurements|||Number
2618637|NCT01970241|Other Pre-specified|Incidence of Hyperglycemia Defined as Point of Care Glucose 180 - 300 mg/dL|Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements 180 - 300 mg/dL.|From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.||||Percentage of total measurements|||Number
2624504|NCT01923480|Secondary|Plasma Concentration of Lysine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
2618642|NCT01969851|Secondary|Number of Subjects Experiencing at Least 1 Treatment-emergent Adverse Event From Baseline to End of Study (Approximately 32 Weeks)|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.|From Baseline to End of Study (approximately 32 weeks)|The Safety Set (SS) included all enrolled subjects who took at least 1 dose of lacosamide (LCM).|||Participants|||Count of Participants
2618643|NCT01969851|Secondary|Number of Subject Withdrawals Due to Adverse Events From Baseline to End of Study (Approximately 32 Weeks)|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.|From Baseline to End of Study (approximately 32 weeks)|The Safety Set (SS) included all enrolled subjects who took at least 1 dose of lacosamide (LCM).|||Participants|||Count of Participants
2618644|NCT01969851|Secondary|Mean Changes in Count of 3 Hz Spike-wave Discharges (During Waking Hours) on 24-hour Ambulatory EEG From Visit 2 to Visit 6|The mean change in the count of 3 Hertz (Hz) spike-wave discharges was presented. Visit 6 (Week 6) was the End of the Titration Period.|From Baseline (Day 1) to Visit 6 (Week 6)|The Safety Set (SS) included all enrolled subjects who took at least 1 dose of lacosamide (LCM).|||count of discharges||Standard Deviation|Mean
2618645|NCT01969851|Primary|Mean Change in Days With Any Generalized Seizures (Absence, Myoclonic, Clonic, Tonic, Tonic-clonic, Atonic, Partial Evolving to Secondarily Generalized) Per 28 Days From the Baseline Period to the Maintenance Period (Approximately 24 Weeks)|The mean change in the count of days with generalized seizures was presented.|Baseline Period to the Maintenance Period (approximately 24 weeks)|The Safety Set (SS) included all enrolled subjects who took at least 1 dose of lacosamide (LCM).|||days||Standard Deviation|Mean
2618646|NCT01969851|Primary|Mean Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 to Visit 6|The mean change in the count of generalized spike-wave discharges was presented. Visit 6 (Week 6) was the End of the Titration Period.|From Baseline (Day 1) to Visit 6 (Week 6)|The Safety Set (SS) included all enrolled subjects who took at least 1 dose of lacosamide (LCM).|||discharges||Standard Deviation|Mean
2618647|NCT01969799|Secondary|Clinical Relapse Rate|Clinical relapse rates (defined as a new episode of pneumonia requiring reinstitution of IV antibiotics) from Day 11 through Day 28|Day 11 - Day 28|MITT|||participants|||Number
2618648|NCT01969799|Secondary|Mortality From Day 1 Through Day 28|Mortality from Day 1 through Day 28, all causes, does not reflect just infection only|Day 1 - Day 28|MITT|||participants|||Number
2618649|NCT01969799|Secondary|Microbiological Response Rates in Patients Positive for Multi-drug Resistant Gram-negative Bacteria|Microbiological response rates at Day 14 in patients whose pre-study treatment bronchoalveolar lavage (BAL) was positive for multi-drug resistant Gram-negative bacteria. Response is defined as not have a positive tracheal aspirate culture on Day 14|Day 14|patients with MDR bacteria at baseline BAL|||Participants|||Count of Participants
2618650|NCT01969799|Secondary|Number of ICU Days From Day 1 Through Day 28||Day 1 - Day 28|MITT|||Days||Standard Deviation|Mean
2618651|NCT01969799|Secondary|Number of Days Free of Mechanical Ventilation From Day 1 Through Day 28|Number of days free of mechanical ventilation from Day 1 through Day 28 mean days.|Day 1 - Day 28|MITT|||Days ± SD||Standard Deviation|Mean
2618652|NCT01969799|Secondary|Composite Endpoint of Mortality and Ventilator-free Days|The hierarchical composite endpoint of mortality, then ventilator-free days. The table reflects winners of matched pairs, ties are not noted.|Day 1- Day 28|MITT|||participants|||Number
2618653|NCT01969799|Secondary|Composite Endpoint of Mortality and Clinical Cure|The hierarchical composite endpoint of mortality, then clinical cure (defined as both absence of Gram-negative bacteria and CPIS at Day 14 < 6). The tables reflect a winner of matched pairs, ties are not noted.|Day 1 - Day 28|MITT|||participants|||Number
2618654|NCT01969799|Primary|Change From Baseline in Clinical Pulmonary Infection Score (CPIS) For Each Patient, Value Obtained From a Daily Assessment Over the 10 Day Study Period Was Compared to Baseline, and the LSM Data Represent the Change From Baseline Data Over All Days .|Change from baseline in Clinical Pulmonary Infection Score (CPIS) For each patient, value obtained from a daily assessment over the 10 day study period was compared to baseline, and the LSM data represent the change from baseline data over all days. Daily CPIS will be determined by one blinded, central reviewer in order to minimize inter-observer variability. The scale ranges from 0 to 13, with 13 being the worst. The value of zero would be a healthy patient with no evidence of pneumonia. For each patient, there was a daily assessment for the 10 day study period.|10 day treatment period.|MITT|||units on a scale||Standard Error|Least Squares Mean
2618655|NCT01969747|Primary|Change From Baseline in 24 h UGE (g/24 h) After Seven Days of Treatment With Empagliflozin 2.5 mg, 10 mg, or 25 mg, or Placebo|"Change of urinary glucose excretion (UGE) (g/24 h) from baseline (refers to the last measurement prior to the first intake of any randomised trial medication) after seven days of treatment with empagliflozin 2.5 mg, 10 mg, or 25 mg, or placebo.~The treatment effect was estimated on the basis of the least square mean treatment difference at Day 7 extracted from the primary analysis model.~The primary endpoint is exploratory."|baseline (Day -1) and 7 days after first drug administration (Day 7)|"Full analysis set (FAS): all patients randomised, treated with at least one dose of study drug, had a baseline UGE (g/24 h) and a UGE (g/24 h) on Day 1 or Day 7.~The last observation carried forward (LOCF) approach was used as the primary method of imputation for missing data."|||g/24h||Standard Error|Mean
2618656|NCT01969721|Secondary|FEV1 Peak (0−3h) Change From Patient Baseline After 6 Weeks of Treatment|Change from patient baseline in Forced Expiratory Volume in one second (FEV1) peak (0-3 hours) after 6 weeks of treatment. FEV1 peak (0-3 hours) was defined as the maximum FEV1 value measured within the first three hours post dosing. Measured values presented are actually adjusted means.|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.|||Litres||Standard Error|Mean
2618706|NCT01969214|Secondary|Evaluation of Subjects' Energy Level|The subjective measure of subjects' daily energy level was determined by severity of weakness felt by the subjects, measured on visual analog scale (0-100mm, 100mm being most severe weakness).|96 hours|Only 85 subjects responded to Day 3 and only 67 subjects responded to Day 4 assessment of weakness|||mm||Standard Deviation|Mean
2618657|NCT01969721|Secondary|FEV1 AUC (12−24h) Change From Patient Baseline After 6 Weeks of Treatment|"Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 12 to 24 hours post-dose (AUC 12-24h) [L] after 6 weeks of treatment. Measured values presented are actually adjusted means.~The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient."|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.|||Litres||Standard Error|Mean
2618658|NCT01969721|Secondary|Trough FEV1 Change From Patient Baseline After 6 Weeks of Treatment|"Change from patient baseline in Trough Forced Expiratory Volume in one second (FEV1) after 6 weeks of treatment. Trough FEV1 was defined as the mean of the 23h and 23h 50min (minutes) post-dose FEV1 measurements. Measured values presented are actually adjusted means.~The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient."|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.|||Litres||Standard Error|Mean
2618659|NCT01969721|Secondary|FEV1 AUC (0−24h) Change From Patient Baseline After 6 Weeks of Treatment|"Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 24 hours post-dose (AUC 0-24h) [L] after 6 weeks of treatment.~Measured values presented are actually adjusted means. The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient."|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.|||Litres||Standard Error|Mean
2618660|NCT01969721|Primary|FEV1 AUC (0−12h) Change From Patient Baseline After 6 Weeks of Treatment|"Change from patient baseline in Forced Expiratory Volume in one second (FEV1) Area Under the FEV1-time Curve from 0 to 12hours post-dose (AUC 0-12h) [L] after 6 weeks of treatment. Measured values presented are actually adjusted means.~The period baseline is defined as the pre-dose measurement taken at on the day 1 of each period. The patient baseline is defined as the mean of non-missing period baselines for each patient."|Baseline and 6 weeks.|FAS (Full Analysis Set): Included all randomised patients who were documented to have had received any dose of trial medication and who had both baseline and any evaluable post-baseline measurement for the primary efficacy endpoint.|||Litres||Standard Error|Mean
2618661|NCT01969708|Secondary|Number of Study Eyes With Central Subfield Thickness <300 μm, no Subretinal Fluid, no Intraretinal Fluid, and no Cystoid Spaces|The measure is the number of study eyes with central subfield thickness <300 μm, no subretinal fluid, no intraretinal fluid, and no cystoid spaces at month 6|Month 0 to 6|All participants with central subfield thickness recorded at Month 6|||study eyes|||Number
2618662|NCT01969708|Secondary|Mean Change From Baseline in Spectral Domain Optical Coherence Tomography Central Subfield Thickness at Month 6|The measure is calculated by subtracting the baseline central subfield thickness from the month 6 central subfield thickness|Month 0 to 6|All participants with central subfield thickness recorded at baseline and Month 6|||um||95% Confidence Interval|Mean
2618663|NCT01969708|Secondary|Mean Spectral-domain Optical Coherence Tomography Central Subfield Thickness|The measure is the mean central subfield thickness at month 6 measured by spectral-domain optical coherence tomography|Month 0 to 6|All participants with central subfield thickness recorded at baseline and Month 6|||um||95% Confidence Interval|Mean
2618664|NCT01969708|Secondary|Number of Study Eyes With Visual Acuity Letter Score of 70 or Better at Month 6|The measure is the number of study eyes with a visual acuity letter score of 70 (Snellen equivalent of 20/40) or better at month 6|Month 0 to 6|All participants with visual acuity letter score recorded at Month 6|||study eyes|||Number
2618665|NCT01969708|Secondary|Number of Study Eyes With Gain of ≥15 Letters in Visual Acuity Letter Score at Month 6|The measure is the number of study eyes that gained at least 15 letters in their visual acuity letter score at month 6|Month 0 to 6|All participants with visual acuity letter score recorded at Month 6|||study eyes|||Number
2618666|NCT01969708|Primary|Mean Change From Baseline in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score at Month 6|The primary analysis is based on observed data at 6 months. The measure is calculated by subtracting the baseline visual acuity letter score from the month 6 visual acuity letter score. The participant is refracted for best corrected vision, and then reads single letters on an electronic visual acuity tester at a 3 meter distance according to a specific algorithm. A letter score is provided that ranges from 0 (unable to ready any letters) to 100. A visual acuity letter score of 85 corresponds to a visual acuity of 20/20 as a Snellen equivalent.|Month 0 to 6|All participants with visual acuity letter score recorded at Month 6|||letters read||95% Confidence Interval|Mean
2618667|NCT01969565|Secondary|Overall Response Rate (ORR), Defined as sCR, CR, Very Good Partial Response (VGPR), and PR at 4 Cycles|The ORR will be estimated based on the crude proportion of subjects for whom best overall response is sCR, CR, VGPR, and PR.|4 months|Patient withdrew consent before receiving treatment||||||
2618668|NCT01969565|Primary|Patients With ≥ VGPR (Very Good Partial Response)|VGPR will be estimated based on the crude proportion of subjects whose best response is Stringent Complete Response (sCR), Complete Response (CR), and VGPR.|4 months-8 months|Patient withdrew consent before receiving treatment||||||
2618669|NCT01969565|Primary|Tolerability and Safety of Increasing Doses of Carfilzomib in Combination With Dexamethasone.|Adverse events will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) adverse event dictionary. The results will be tabulated to examine their frequency, organ systems affected, and relationship to study treatment. The results of laboratory assessments will be evaluated similarly.|24 months|Patient withdrew consent before receiving treatment||||||
2618707|NCT01969214|Secondary|Time Off From Work||1 week||||Percentage of subjects|||Number
2618708|NCT01969214|Secondary|Abdominal Pain|Subjects feeling of abdominal pain was measured on visual analog scale of 0 - 100mm (no pain to severe pain).|96 hours|All 86 subjects recorded abdominal pain on day 1 and day 2. 85 subjects recorded abdominal pain on day 3 and 67 subjects recorded abdominal pain on day 4.|||mm||Standard Deviation|Mean
2618670|NCT01969539|Primary|Pre-dose Subtracted Maximum Measured Concentration of Albuterol|"Pre-dose subtracted maximum measured concentration (Cmax) of albuterol.~Standard pharmacokinetic (PK) analyses were not conducted due to a carry-over effect. As a consequence, the pre-specified primary endpoint (maximum measured concentration of ipratropium and albuterol) was not reported. The predose subtracted Cmax was calculated instead of the primary endpoint."|Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication|Treated set|||ng/ml||Standard Deviation|Mean
2618671|NCT01969539|Secondary|Area Under the Concentration-time Curve Over the Time Interval From 0 to 6 Hour (AUC 0-6) of Ipratropium and Albuterol|"Area under the concentration-time curve over the time interval from 0 to 6 hour (AUC 0-6) of ipratropium and albuterol.~This secondary endpoint was not calculated due to a carry-over effect."|Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication|Treated set||||||
2618672|NCT01969539|Primary|Pre-dose Subtracted Maximum Measured Concentration of Ipratropium|"Pre-dose subtracted maximum measured concentration (Cmax) of ipratropium.~Standard pharmacokinetic (PK) analyses were not conducted due to a carry-over effect. As a consequence, the pre-specified primary endpoint (maximum measured concentration of ipratropium and albuterol) was not reported. The predose subtracted Cmax was calculated instead of the primary endpoint."|Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication|Treated set|||pg/ml||Standard Deviation|Mean
2618673|NCT01969500|Secondary|Usability and Satisfaction|Usability and Satisfaction was measured using the USE (Usefulness, Satisfaction, and Ease of use) Questionnaire, which was designed to measure satisfaction, usefulness, ease of use and ease of learning.|4 weeks|This data was collected in a previous field trial, not in this randomized controlled trial.||||||
2618674|NCT01969500|Secondary|Change in System Use|System use was measured by the SOS application regarding the percent of SOS prompts and self-report interactions with the system.|4 weeks|This data was collected in a previous field trial, not in this randomized controlled trial.||||||
2618675|NCT01969500|Primary|Change in Social Functioning|Social Functioning was measured using two subscales from the Social Functioning Scale (SFS): Social Engagement (5-items) and Withdrawal & Communication (10-items). The item values range from 0 (almost never) to 3 (often). The two subscales were summed to give a score between 0-45. A higher score indicates greater social functioning.|Baseline, week 12|N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.|||units on a scale||Standard Error|Mean
2618676|NCT01969500|Primary|Change in Severity of Psychotic Symptoms|Severity of Psychotic Symptoms was assessed with the Psychotic Symptom Rating Scales (PSYRATS). The PSYRATS is comprised of 17 items inquiring about the specific dimensions of hallucinations and delusions, with each item being rated from 0 (absent) to 4 (severe). The PSYRATS has 2 subscales: the auditory hallucinations subscale (AHS) consisting of 11 items, and the delusions subscale (DS) consisting of 6 items. These subscale scores are added to create a total score ranging from 0-68. Higher scores indicate worse symptoms.|Baseline, week 12|N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.|||units on a scale||Standard Error|Mean
2618677|NCT01969448|Secondary|Breast Weight||At time of surgery (day 1)||||grams||Standard Deviation|Mean
2618678|NCT01969448|Secondary|Mean Operative Times for Mastectomy||At the time of surgery (day 1)||||minutes||Standard Deviation|Mean
2618679|NCT01969448|Secondary|Number of Participants With Tissue Expander||Up to 3 months post permanent implant placement||||Participants|||Count of Participants
2618680|NCT01969448|Secondary|Breast Q Score|-The BREAST-Q is a previously validated instrument which measures patient reported outcomes. It has several iterations including the one utilized here which is specific for implant-based breast reconstruction. Each of its 6 domains generates a Q-score from 0 (lowest) to 100 (highest). A higher number indicates a higher satisfaction or better quality of life than a lower number. Based on answers to the questions, each individual will generate a whole number score for each domain. The patient can be sampled preoperatively and postoperatively as well as over time to calculate the impact of intervention and time on this value. Q-scores are calculated for each domain, and the investigators report a mean value based on data from an entire cohort for the particular domain. Domains include evaluation of overall satisfaction with breasts, physical well being, sexual well being, as well as satisfaction with office staff, information provided, and the provider.|Up to 3 months post permanent implant placement|6 participants were not evaluable for this outcome measure in the inframammary fold incision cohort and 2 particpants were not evaluable for this outcome measure in the lateral radial incision cohort due to not completing the Breast Q score.|||units on a scale||Standard Deviation|Mean
2618681|NCT01969448|Primary|Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction|"Laser-assisted fluorescent angiography via the Spy Elite imaging device will be utilized to capture this data during mastectomy and immediate breast reconstruction. Standard postoperative patient follow up will assess for perfusion.~The Spy device quantifies perfusion by measuring relative fluorescence of indocyanine green bound to plasma proteins. This produces an intensity value of 0-255 based on an 8-bit greyscale. The investigators measured this value preoperatively when measured and compared to the post-intervention measurement. The device can calculate the cumulative intensity of a defined region of interest which the investigators categorized as the lateral, lower, medial, or nipple-areola region of the breast. The investigators also evaluated the cumulative value of these areas in total. Rate of perfusion was simply this value over time (90 seconds)."|At the time of surgery (day 1)||||percentage of original preop perfusion|||Number
2618702|NCT01969214|Secondary|Stool Consistency|"Stool consistency is measured by Bristol Stool Form Scale 1-7.~Separate hard lumps, like nuts (hard to pass)~Sausage-shaped, but lumpy~Like a sausage but with cracks on its surface~Like a sausage or snake, smooth and soft~Soft blobs with clear cut edges (easy to pass)~Fluffy pieces with ragged edges, a mushy stool~Watery, no solid pieces, entirely liquid Stool consistency is the mean of the scale measured each day."|96 hours|387, 278, 200 and 82 stool samples were obtained on day 1, 2, 3 and 4 respectively.|||score on a scale|stool samples|Standard Deviation|Mean
2618703|NCT01969214|Secondary|Associated Symptoms Such as Vomiting||96 hours||||Percentage of subjects|||Number
2618704|NCT01969214|Secondary|Occurrence of Adverse Events (AEs)||96 hours||||Adverse Events|||Number
2618682|NCT01969448|Primary|Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy|"Laser-assisted fluorescent angiography via the Spy Elite imaging device will be utilized to capture this data during mastectomy and immediate breast reconstruction. Standard postoperative patient follow up will assess for perfusion.~The Spy device quantifies perfusion by measuring relative fluorescence of indocyanine green bound to plasma proteins. This produces an intensity value of 0-255 based on an 8-bit greyscale. The investigators measured this value preoperatively when measured and compared to the post-intervention measurement. The device can calculate the cumulative intensity of a defined region of interest which the investigators categorized as the lateral, lower, medial, or nipple-areola region of the breast. The investigators also evaluated the cumulative value of these areas in total. Rate of perfusion was simply this value over time (90 seconds)."|At the time of surgery (day 1)||||percentage of original preop perfusion|||Number
2618683|NCT01969435|Post-Hoc|Overall Survival (OS) Rate||Median follow-up 15.4 months (range 4.7-24.6)||||percentage of participants|||Number
2618684|NCT01969435|Post-Hoc|Relapse Free Survival||1 year||||percentage of participants|||Number
2618685|NCT01969435|Post-Hoc|Progression-free Survival Rate (PFS)||1 year||||percentage of participants||95% Confidence Interval|Median
2618686|NCT01969435|Post-Hoc|Progression-free Survival (PFS) Rate|PFS - Time from start of treatment to the time of progression or death, whichever occurs first.|6 months||||percentage of participants||95% Confidence Interval|Median
2618687|NCT01969435|Secondary|Time to Engraftment (Platelet)|Time from the date of transplant to the date of platelet engraftment.|Assessed up to day 100|One patient did not have platelet engraftment by Day 100|||days||Full Range|Median
2618688|NCT01969435|Secondary|Time to Engraftment (Neutrophil)|Time from the date of the transplant to the date of neutrophil engraftment.|Assessed up to day 30||||days||Full Range|Median
2618689|NCT01969435|Secondary|Disease-free Survival|Percentage of patients who survive without any signs or symptoms of cancer at 2 years.|2 years||||percentage of participants|||Number
2618690|NCT01969435|Secondary|Disease-free Survival|Percentage of patients who survive without any signs or symptoms of cancer at 1 year.|1 year||||percentage of participants||95% Confidence Interval|Number
2618691|NCT01969435|Secondary|Efficacy as Measured by Response Rates|"The response rates according to each category of response Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) will be summarized by the proportion of patients meeting each criterion.~Evaluated using PET or CT scan and Revised Response Criteria for Malignant Lymphoma"|Up to Day 100||||percentage of participants|||Number
2618692|NCT01969435|Primary|Treatment-related Mortality (TRM)|TRM is defined as death not due to progressive lymphoma prior to Day 100 after transplant|100 days||||percentage of participants|||Number
2618693|NCT01969435|Primary|Safety and Toxicity as Measured by Treatment Related Non-hematologic Adverse Events|Adverse events will be assessed using the National Cancer Institute (NCI)-CTCAE version 4.0. Number of events, grade 2 or higher, occurring in 10% or greater of participants. Grade 2 diarrhea and Grade 2 nausea/vomiting were not recorded.|Day -7 through Day 30||||participants|||Number
2618694|NCT01969240|Secondary|Physician Trust|The trust in physician scale consists of 9 items scored from 1-5; the items are subtracted by 1, summed, divided by 9, and then multiplied by 25. The scale ranges from 0-100, where higher values are reflective of higher levels of patient trust in their physician.|Immediately after the visit (day 1)||||units on a scale||Standard Deviation|Mean
2618695|NCT01969240|Secondary|Decisional Conflict|Decisional conflict, which represents the degree of uncertainty patients experience related to feeling uninformed about the management options, is measured by the decisional conflict scale. The decisional conflict scale includes 16 items that are scored from 0-4; the items are summed, divided by 16, and then multiplied by 25. The scale is from 0-100, where higher scores are reflective of increased patient uncertainty about the choice.|Immediately after the visit (day 1)||||units on a scale||Standard Deviation|Mean
2618696|NCT01969240|Secondary|Total Testing Within 45 Days (a Component of Healthcare Utilization)|In addition to measuring the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days, we measured the total number of tests of any type within 45 days. Although we pre-specified 30-day healthcare utilization, on further discussion among the investigative team the consensus was that we collected utilization data out to 45 days and reporting testing utilization at 45 days will provide more robust results.|45 days||||number of tests obtained||Standard Deviation|Mean
2618697|NCT01969240|Secondary|Major Adverse Cardiac Event (MACE)|A MACE was defined as acute myocardial infarction, death due to a cardiac or unknown cause, emergency revascularization, ventricular arrhythmia, or cardiogenic shock.|within 30 days of enrollment||||participants|||Number
2618698|NCT01969240|Secondary|Test if the Decision Aid Safely Improves Patient Engagement.|1) Patient engagement in the decision-making process as measured by the OPTION scale. The OPTION scale is composed of 12 items with a value of 0-4; they are summed, divided by 48, and then multiplied by 100. Scores range from 0-100, where higher scores are reflective of higher levels of patient engagement.|Immediately after the intervention (on day 1)||||units on a scale||Standard Deviation|Mean
2618699|NCT01969240|Secondary|Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment.|We will measure the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days of enrollment.|Within 30 days of study enrollment||||participants|||Number
2618700|NCT01969240|Primary|Test if Chest Pain Choice Safely Improves Patient Knowledge.|Patient knowledge was measured by immediate post-visit survey that included 8 questions about the patient's risk for acute coronary syndrome and the available management options.|Directly following intervention (on day 1)||||number of questions correct||Standard Deviation|Mean
2618701|NCT01969214|Secondary|Severity of Nausea|Subjects feeling of nausea was measured on visual analog scale of 0 - 100mm (no nausea to severe nausea).|96 hours|All 86 subjects recorded nausea on day 1 and day 2. 85 subjects recorded nausea on day 3 and 67 subjects recorded nausea on day 4.|||mm||Standard Deviation|Mean
2618705|NCT01969214|Secondary|Global Evaluation of Safety and Efficacy by Subjects and Investigators|"The subjects and investigators will evaluate independently the safety of the investigational device (global scaled evaluation with very good, good, moderate and poor)."|96 hours||||participants|||Number
2618714|NCT01969214|Primary|Time (in Hours) Between the 1st Intake of IQP-MM-101 and First Formed or Hard Stool (Type 6 to 1) Followed by a Non Watery Stool (Type 6 to 1)|In essence the definition of recovery would be two consecutive non-watery stool (type 6 to 1) when stool before 1st intake of IQP-MM-101 is primarily watery (type 7).|96 hours|6 participants recovered before first intake of IQP-MM-101, while in another, there was no defecation reported.|||hours||Standard Deviation|Mean
2618715|NCT01969201|Secondary|Cumulative Pregnancy Rate|Patients who will not get pregnant during the study, will be allowed to perform a frozen embryo transfer. Cumulative pregnancy rate will include also pregnancies achieved after a frozen embryo transfer.|2 years||||percentage of participants|||Number
2618716|NCT01969201|Secondary|Delivery Rate||9 months|For 4 patients, 3 allocated to the Fostimon® group and 1 allocated to the Gonal-F® group this information was not available because of lost to follow-up.|||percentage of participants|||Number
2618717|NCT01969201|Secondary|Positive Serum Pregnancy Test Rate|Two weeks after embryo transfer, a serum pregnancy test will be performed.|2 weeks after embryo transfer||||percentage of participants|||Number
2618718|NCT01969201|Secondary|Embryo Quality (Number of Top Quality Embryos Transferred Per Patient)|The embryo quality evaluation will be performed on culture day 3, just before embryo transfer and will consist in the assessment of blastomeres number and 2 embryo morphology parameters: degree of fragmentation and cell division aspect.|On culture day 3|Subject with at least one embryo transferred, with embryo scoring available.|||Top embryos||Standard Deviation|Mean
2618719|NCT01969201|Secondary|Fertilization Rate||end of treatment period, approximately 2 - 3 weeks|subjects with at least one oocyte inseminated.|||percentage of oocytes||Standard Deviation|Mean
2618720|NCT01969201|Secondary|Total Number of Oocytes Retrieved||end of treatment period, approximately 2 - 3 weeks.|subjects who underwent oocytes retrieval|||oocytes||Standard Deviation|Mean
2618721|NCT01969201|Secondary|Number of Follicles >16 mm on the Day of hCG Injection||10-15 days after starting FSH stimulation|Subject with available data.|||follicles >16 mm||Standard Deviation|Mean
2618722|NCT01969201|Primary|Clinical Pregnancy Rate|A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation;|8 weeks||||percentage of participants|||Number
2618723|NCT01969162|Primary|Tear Lipid Composition Profile|Basal (non-stimulated) tear samples were collected from one eye for lipid analysis. 13 different lipids classes were detected in individual tear samples. The concentration of each lipid class is reported in picomoles (pmole).|Day 1|A subset of enrolled participants who had non-stimulated (basal) tear samples.|||pmole||Standard Deviation|Mean
2618724|NCT01969084|Secondary|Changes in Circulating Endothelial Progenitor Cell Phenotypes|The measurements of the various EPC phenotypes were performed at the Beth Israel Deaconess Flow Cytometry Core Facility. Immunofluorescent cell staining was performed on peripheral blood with the use of the fluorescent conjugated antibodies. 1.000.000 events per sample were acquired using a FACS LSR II analyzer (Becton Dickinson, Franklin Lakes, NJ, USA) and the results were analyzed using the Beckman Coulter Kaluza analysis software (Beckman Coulter Inc., Brea, CA, USA).|Baseline and 12 weeks||||Events per million||Inter-Quartile Range|Median
2618725|NCT01969084|Secondary|Changes in SDF1-α and Substance P||Baseline and 12 weeks||||pg/ml||Inter-Quartile Range|Median
2618726|NCT01969084|Secondary|Changes in Vascular Reactivity in the Micro- and Macro-circulation.|Change in markers of macro- and microvascular function from the baseline visit to the post-treatment visit between the two groups.|Baseline and 12 weeks||||percent change||Inter-Quartile Range|Median
2618727|NCT01969084|Secondary|Change in Muscle Oxygenation Recovery Time|Change in muscle oxygenation after ischemia inducing occlusion for 4 minutes.|Baseline and 12 weeks||||seconds||Inter-Quartile Range|Median
2618728|NCT01969084|Primary|Phosphocreatine (PCR) Recovery Time After Exhaustive or up to 6 Minutes of Leg Exercise.|Change in the time to phosphocreatine recovery between the baseline visit and post-treatment visit following the graded exercise test.|Baseline and 12 weeks||||seconds||Inter-Quartile Range|Median
2618729|NCT01969058|Secondary|Primary Targeted Adverse Events|Targeted events for A5325 include: events that meet the International Conference on Harmonization (ICH) definitions for a serious adverse event, post-entry signs/symptoms and laboratory abnormalities of Grade ≥3 or that lead to a change in treatment regardless of grade, and any diagnoses.|from study entry to end of study (week 28)|all enrolled participants|||Participants|||Count of Participants
2618730|NCT01969058|Secondary|Pharmacokinetics - 12-hour Levels of EFV for Isotretinoin Arm|"Isotretinoin arm (Arm A) only, 12-hour levels of EFV (Efavirenz) is defined as the average of 'eligible' concentrations, where 'eligible' means the time from the previous dose to the blood draw of the sample must have been in the 9-to-15 hour range, and the participant must have taken at least 3 doses in the prior 4 days.~EFV trough during Isotretinoin administration is the average of 'eligible' concentrations from weeks 8, 12, and 16; EFV trough without Isotretinoin administration is the average of 'eligible' concentrations from weeks 0 and 20.~(Week 28 data is not available.)"|weeks 0, 8, 12, 16, 20|Included only Isotretinoin arm participants who were on EFV and on Isotretinoin for 8 weeks of more, and with available EFV 12-hour levels.|||ng/mL||Inter-Quartile Range|Median
2618731|NCT01969058|Secondary|Pharmacokinetics - Trough Concentrations of TDF for Isotretinoin Arm|"Isotretinoin arm (Arm A) only, trough concentrations of TDF (Tenofovir) is defined as the average of 'eligible' concentrations, where 'eligible' means the time from the previous dose to the blood draw of the sample must have been in the 20-to-28 hour range, and the participant must have taken at least 3 doses in the prior 4 days.~TDF trough during Isotretinoin administration is the average of 'eligible' concentrations from weeks 8, 12, and 16; TDF trough without Isotretinoin administration is the average of 'eligible' concentrations from weeks 0 and 20.~(Week 28 data is not available.)"|weeks 0, 8, 12, 16, 20|Included only Isotretinoin arm participants who were on TDF and on Isotretinoin for 8 weeks of more, and with available TDF trough.|||ng/mL||Inter-Quartile Range|Median
2618732|NCT01969058|Secondary|Pharmacokinetics - Steady-state Trough Concentrations of Isotretinoin for Isotretinoin Arm|Isotretinoin arm (Arm A) only, steady-state trough concentrations of Isotretinoin is defined as the average of 'eligible' concentrations at weeks 8, 12, and 16, where 'eligible' means the time from the previous dose to the blood draw of the sample must have been in the 14-to-30 hour range, and the participant must have taken at least 3 doses in the prior 4 days.|weeks 8, 12, 16|Included only Isotretinoin arm participants who were on Isotretinoin for 8 weeks of more and have steady state troughs available.|||pmol/mL||Inter-Quartile Range|Median
2618733|NCT01969058|Secondary|Pharmacokinetics - Endogenous Levels of Retinoid Metabolites for Isotretinoin Arm|Isotretinoin Arm (Arm A) only. Endogenous retinoid metabolites are defined as the average concentrations of Retinol, and Total Retinyl Ester from weeks 0, 20, and 28.|weeks 0, 20, 28|Included only Isotretinoin arm participants who were on Isotretinoin for 8 weeks of more.|||nmol/mL||Inter-Quartile Range|Median
2618734|NCT01969058|Secondary|Change in Th17 Frequency (%IFNg-/IL17+(CD161+/CCR6+))|"Th17 (T-helper 17) cells are a subset of pro-inflammatory T helper cells defined by their production of interleukin 17 (IL-17).~The outcome is the change in percent IFNg-/IL17+(CD161+/CCR6+) from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||percentage of CD161+/CCR6+ cells||Inter-Quartile Range|Median
2618735|NCT01969058|Secondary|Change in Treg Frequency (%FoxP3+/CD25hi+/CD39+/CD127-(CD4+))|"Treg (T Regulatory) Cells are a subpopulation of T cells which modulate the immune system.~The outcome measure is the change in percent FoxP3+/CD25hi+/CD39+/CD127-(CD4+) from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||percentage of CD4 cells||Inter-Quartile Range|Median
2618736|NCT01969058|Secondary|Cell-associated HIV-1 DNA|"Cell-associated HIV-1 DNA in blood at baseline, week 14/16, and week 28. Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.~For cell-associated HIV-1 DNA results below the assay limit, the lowest value of the sample was imputed to these results and considered lowest ranks (1.62 log10 copies/10^6 CD4 cells).~It was originally planned to summarize the absolute changes for cell-associated HIV-1 DNA. However, since there are many results below limit of detection, analyzing the absolute changes would be inappropriate in this case.~Instead, the baseline, week 14/16, and week 28 levels were summarized."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16~have cell-associated HIV-1 DNA data"|||log10 copies/million CD4 cells||Inter-Quartile Range|Median
2618737|NCT01969058|Secondary|Change in Cell-associated HIV-1 RNA|"Cell-associated HIV-1 RNA in blood from baseline to week 14/16(week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16.~For cell-associated HIV-1 RNA results below the assay limit, the lowest value of the sample was imputed to these results (1.32 log10 copies/10^6 CD4 cells).~Since there are only a few results below the assay limit, it is still reasonable to summarize the absolute changes for cell-associated HIV-1 RNA, where changes were calculated based on the imputed values (described above) for below assay limit results."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16~have cell-associated HIV-1 RNA data"|||log10 copies/million CD4 cells||Inter-Quartile Range|Median
2618738|NCT01969058|Secondary|Change in CD4+ T-cell Count|"Change in peripheral total CD4 cell count from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||cells/mm^3||Inter-Quartile Range|Median
2618739|NCT01969058|Secondary|Change in sCD163|"sCD163 (soluble CD 163) is a marker of macrophage activation Change in log10 transformed sCD163 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||log10 ng/mL||Inter-Quartile Range|Median
2618740|NCT01969058|Secondary|Change in TF|"TF (Tissue Factor) is a marker of Coagulation. Change in log10 transformed TF from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||log10 pg/mL||Inter-Quartile Range|Median
2618750|NCT01968980|Secondary|Percentage of Participants With Positive Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)|Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported in this outcome measure. ADA titer greater than or equal to (>=) 6.23 were considered as ADA positive and nAb titer level >=1.58 were considered as nAb positive.|Baseline up to the end of study (up to 58 weeks)|Analysis was performed on all participants who received at least 1 dose of PF-04950615.|||percentage of participants|||Number
2618741|NCT01969058|Secondary|Change in D-dimer|"D-dimer (or D dimer) is a marker of coagulation activation. Change in log10 transformed D-dimer from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||log10 ng/mL||Inter-Quartile Range|Median
2618742|NCT01969058|Secondary|Change in sTNF-r2|"sTNF-r2 (soluble tumour necrosis alpha receptor 2) is a marker of inflammation. Change in log10 transformed sTNF-r2 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||log10 pg/mL||Inter-Quartile Range|Median
2618743|NCT01969058|Secondary|Change in sTNF-r1|"sTNF-r1 (soluble tumour necrosis alpha receptor 1) is a marker of inflammation. Change in log10 transformed sTNF-r1 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||log10 pg/mL||Inter-Quartile Range|Median
2618744|NCT01969058|Secondary|Change in hsCRP|"hsCRP (high-sensitivity C-reactive protein) is a marker of inflammation. Change in log10 transformed hsCRP from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||log10 ng/mL||Inter-Quartile Range|Median
2618745|NCT01969058|Secondary|Change in IL-6|"IL-6 (Interleukin-6) is a marker of systemic inflammation. The outcome measures are changes in log10 transformed IL-6 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||log10 pg/mL||Inter-Quartile Range|Median
2618746|NCT01969058|Secondary|Change in I-FABP|"I-FABP (intestinal-fatty acid binding protein) is a marker of intestinal cell damage and turnover.~The outcome measures are changes in log10 transformed I-FABP from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||log10 pg/mL||Inter-Quartile Range|Median
2618747|NCT01969058|Secondary|Change in sCD14|"sCD14 (soluble cluster of differentiation 14) is a marker of gut microbial translocation and monocyte activation.~The outcome measures are changes in log10 transformed sCD14 from baseline to week 14/16 (week 14/16 - baseline), from week 14/16 to week 28 (week 28 - week 14/16), and from baseline to week 28 (week 28 - baseline).~Levels measured at pre-entry and entry were averaged for baseline, levels measured at week 14 and week 16 were averaged for week 14/16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||log10 pg/mL||Inter-Quartile Range|Median
2618748|NCT01969058|Secondary|Change in CD8+ T-cell Activation|"Level of CD8+ T-cell activation was determined by measuring the percentage of CD8+ T-cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+.~The endpoint is measuring the change from week 14/16 to week 28 (week 28 - week 14/16) and from baseline to week 28 (week 28 - baseline).~Baseline is defined as the average of pre-entry and entry, and week 14/16 is defined as the average of week 14 and week 16."|baseline, week 14/16, week 28|"The analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||percentage of cells||Inter-Quartile Range|Median
2618749|NCT01969058|Primary|Change in CD8+ T-cell Activation From Baseline to Week 14/16|"Level of CD8+ T-cell activation was determined by measuring the percentage of CD8+ T-cells that expressed both the activation marker CD38+ and Human leukocyte antigen (HLA)-DR+. The endpoint is measuring the change from baseline to week 14/16, where baseline is defined as the average of pre-entry and entry, and week 14/16 is defined as the average of week 14 and week 16.~Change = (week 14/16 - baseline)."|baseline, week 14/16|"The primary analysis is complete case as-treated, and is limited to participants who:~have data for both baseline and week 14/16~(for the Isotretinoin arm) completed treatment (allowing ≤8 missed doses)~did not use prohibited medications~did not experience virologic failure from baseline to week 16"|||percentage of cells||Inter-Quartile Range|Median
2618751|NCT01968980|Secondary|Number of Participants With Adverse Events Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions|Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reaction is a reaction at the site of the subcutaneous injection and characterized by the symptoms of erythema, swelling, tenderness and warmth. Participants with any of the above type 1 or type 3 hypersensitivity reactions and participants with any of the above injection site reactions were reported in this outcome measure.|Baseline up to the end of study (up to 58 weeks)|Safety analysis set included all participants who received at least 1 dose of study treatment.|||participants|||Number
2618752|NCT01968980|Secondary|Plasma PF-04950615 Concentrations at Week 12, 24 and 52||Week 12, 24, 52|Analysis was performed on all participants who received at least 1 dose of PF-04950615. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||microgram per milliliter||Standard Deviation|Mean
2618753|NCT01968980|Secondary|Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Liter) at Week 12, 24 and 52||Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percentage of participants|||Number
2618754|NCT01968980|Secondary|Percentage of Participants Achieving Low Density Lipoprotein Cholesterol (LDL-C) Level Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Liter) at Week 12, 24 and 52||Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percentage of participants|||Number
2618755|NCT01968980|Secondary|Absolute Change From Baseline in Ratio of Apolipoprotein B to Apolipoprotein A-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||ratio||Standard Deviation|Mean
2618756|NCT01968980|Secondary|Absolute Change From Baseline in Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||ratio||Standard Deviation|Mean
2618757|NCT01968980|Secondary|Absolute Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2618758|NCT01968980|Secondary|Absolute Change From Baseline in Lipoprotein (a) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2618759|NCT01968980|Secondary|Absolute Change From Baseline in Apolipoprotein B (ApoB) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2618760|NCT01968980|Secondary|Absolute Change From Baseline in Non- High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2618761|NCT01968980|Secondary|Absolute Change From Baseline in Total Cholesterol (TC) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||mg/dL||Standard Deviation|Mean
2618762|NCT01968980|Secondary|Absolute Change From Baseline in Low Density Lipoprotein (LDL-C) at Week 12||Baseline, Week 12|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2618763|NCT01968980|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
2618764|NCT01968980|Secondary|Percent Change From Baseline in Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
2618765|NCT01968980|Secondary|Percent Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
2618766|NCT01968980|Secondary|Percent Change From Baseline in Triglycerides (TG) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
2618767|NCT01968980|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||percent change||Standard Deviation|Mean
2618768|NCT01968980|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
2618769|NCT01968980|Secondary|Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
2618770|NCT01968980|Secondary|Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
2618771|NCT01968980|Secondary|Percent Change From Baseline in Total Cholesterol (TC) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
2618772|NCT01968980|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
2618773|NCT01968980|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
2618774|NCT01968980|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
2618775|NCT01968980|Secondary|Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
2618776|NCT01968980|Secondary|Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non HDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
2618777|NCT01968980|Secondary|Percent Change From Baseline in Total Cholesterol (TC) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
2618778|NCT01968980|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
2618779|NCT01968967|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Extension Period|Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 (log2) unit was considered to be ADA positive and nAb titer >=1.58 (log2) unit was considered to be nAb positive.|Week 58 follow-up visit, Week 71, Week 84, Week 97, Week 110|"All participants who consented for extension period. This outcome measure was planned not to be analyzed for reporting arms Placebo (Extension period) and Bococizumab ADA negative (Extension period). Here, n signifies number of participants who were evaluable at specified time points."|||Percentage of participants|||Number
2618780|NCT01968967|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 58 Follow-up Visit, 71, 84, 97 and 110: Extension Period||Baseline, Week 58 follow-up visit, 71, 84, 97, 110|"All participants who consented for extension period. This outcome measure was planned not to be analyzed for reporting arms: Placebo (Extension Period) and Bococizumab ADA negative (Extension Period). Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
2618781|NCT01968967|Secondary|Number of Participants Who Changed Concomitant Medication During Extension Period|In this outcome measure, total number of participants who changed their lipid-lowering medications or added a monoclonal antibody medication during the extension period were reported.|Week 58 follow-up visit to Week 110|All participants who consented for extension period.|||Participants|||Count of Participants
2618782|NCT01968967|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb): Treatment Period|Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. ADA titer >=6.23 (log2) unit was considered to be ADA positive and nAb titer >=1.58 (log2) unit was considered to be nAb positive.|Baseline up to Week 58|"Safety analysis population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure for each reporting arm respectively."|||Percentage of participants|||Number
2618783|NCT01968967|Secondary|Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions|Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia's, polysynovitis, fever and if severe then included glomerulonephritis. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, inflammation, mass, pain, paraesthesia, pruritus, swelling, vesicles, warmth, scab and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.|Baseline up to Week 58|Safety analysis set included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2618784|NCT01968967|Secondary|Plasma Concentration of PF-04950615 at Week 12, 24 and 52|Plasma concentration of PF-04950615 at Week 12, 24 and 52 was reported.|Week 12, 24, 52|"Analysis set included participants who received at least 1 dose of PF-04950615. Here, n signifies those participants who were evaluable at specified time points."|||Microgram per milliliter||Standard Deviation|Mean
2618785|NCT01968967|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm respectively.|||percentage of participants|||Number
2618786|NCT01968967|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm respectively.|||percentage of participants|||Number
2618787|NCT01968967|Secondary|Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants evaluable at specified time points."|||Ratio||Standard Deviation|Mean
2618788|NCT01968967|Secondary|Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||Ratio||Standard Deviation|Mean
2618789|NCT01968967|Secondary|Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
2618790|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
2618791|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
2618792|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
2618793|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
2618794|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
2618795|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12||Baseline, Week 12|"A subset of FAS included all participants who were randomized and had TG >=200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
2618796|NCT01968967|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12||Baseline, Week 12|"A subset of FAS included all participants who were randomized and had TG <200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."|||mg/dL||Standard Deviation|Mean
2618797|NCT01968967|Secondary|Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
2618798|NCT01968967|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
2618799|NCT01968967|Secondary|Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
2618800|NCT01968967|Secondary|Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
2618801|NCT01968967|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24, 52: Treatment Period||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, “N” signifies number of participants who were evaluable for this outcome measure.|||percent change||Standard Deviation|Mean
2618802|NCT01968967|Secondary|Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at specified time points."|||percent change||Standard Deviation|Mean
2618803|NCT01968967|Secondary|Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."|||percent change||Standard Deviation|Mean
2618804|NCT01968967|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"A subset of FAS included all participants who were randomized and had TG >=200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."|||percent change||Standard Deviation|Mean
2618805|NCT01968967|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides (TG) Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"A subset of FAS included all participants who were randomized and had TG <200 mg/dL at pre-randomization. Here, n signifies number of participants evaluable at specified time points."|||percent change||Standard Deviation|Mean
2618806|NCT01968967|Secondary|Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."|||percent change||Standard Deviation|Mean
2618807|NCT01968967|Secondary|Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."|||percent change||Standard Deviation|Mean
2618808|NCT01968967|Secondary|Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|"FAS included all participants who were randomized. Here, n signifies number of participants who were evaluable at the specified time points."|||percent change||Standard Deviation|Mean
2618809|NCT01968967|Primary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, Number of participants analyzed (N) signifies number of participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
2618810|NCT01968954|Other Pre-specified|Absolute Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
2618811|NCT01968954|Other Pre-specified|Absolute Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
2618812|NCT01968954|Other Pre-specified|Absolute Change From Baseline in Triglyceride (TG) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
2618813|NCT01968954|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)|Percentage of participants with at least 1 positive ADA titer or 1 positive nAb titer were reported. Participants with their ADA titer >=6.23 were considered to be ADA positive and participants with their nAb titer >=1.58 were considered to be nAb positive.|Baseline up to the end of study (up to 58 weeks)|"Safety analysis set included all participants who received at least 1 dose of study treatment. Participants who received at least 1 dose of PF-04950615 were evaluable for this outcome measure. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2618814|NCT01968954|Secondary|Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions|Type 1 hypersensitivity or allergic reactions were possible in response to any injected protein and included shortness of breath, urticaria, anaphylaxis and angioedema. Type 3 hypersensitivity reactions were similar to Type 1 hypersensitivity reactions but were likely to be delayed from the time of injection and included symptoms such as rash, urticaria, polyarthritis, myalgia's, polysynovitis, fever and if severe then included glomerulonephritis as well. Injection site reactions included injection site bruising, discolouration, erythema, haematoma, haemorrhage, nodule, induration, pain, pruritus and rash. Participants with type 1 or type 3 hypersensitivity reactions and participants with injection site reactions were reported in this outcome measure.|Baseline up to the end of study (up to 58 weeks)|Safety analysis set included all participants who received at least 1 dose of study treatment.|||participants|||Number
2618815|NCT01968954|Secondary|Plasma PF-04950615 Concentrations at Week 12, 24 and 52||Week 12, 24, 52|Analysis set included participants who received at least 1 dose of PF-04950615. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||microgram per milliliter||Standard Deviation|Mean
2618816|NCT01968954|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (1.81 Millimoles Per Litre) at Week 12, 24 and 52||Week 12, 24 and 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percentage of participants|||Number
2618817|NCT01968954|Secondary|Percentage of Participants Achieving Fasting Low Density Lipoprotein-Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (2.59 Millimoles Per Litre) at Week 12, 24 and 52||Week 12, 24 and 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percentage of participants|||Number
2618818|NCT01968954|Secondary|Absolute Change From Baseline in Ratio of Apolipoprotein B to ApolipoproteinA-I (ApoB/ApoA-I Ratio) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||ratio||Standard Deviation|Mean
2618819|NCT01968954|Secondary|Absolute Change From Baseline in Ratio of Fasting Total Cholesterol to High Density Lipoprotein-Cholesterol (TC/HDL-C Ratio) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||ratio||Standard Deviation|Mean
2618820|NCT01968954|Secondary|Absolute Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
2618821|NCT01968954|Secondary|Absolute Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
2618823|NCT01968954|Secondary|Absolute Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
2618824|NCT01968954|Secondary|Absolute Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
2618825|NCT01968954|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
2618826|NCT01968954|Secondary|Absolute Change From Baseline in Fasting Low Density Lipoprotein-C (LDL-C) at Week 12 by Trigylceride Cut-Off|Absolute change from baseline among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.|Baseline, Week 12|FAS included all participants who were randomized.‘Number of participants analyzed’ signifies those participants who were evaluable for this outcome measure and ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||mg/dL||Standard Deviation|Mean
2618827|NCT01968954|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
2618828|NCT01968954|Secondary|Percent Change From Baseline in ApolipoproteinA-II (ApoA-II) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
2618829|NCT01968954|Secondary|Percent Change From Baseline in ApolipoproteinA-I (ApoA-I) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
2618830|NCT01968954|Secondary|Percent Change From Baseline in Fasting Triglyceride (TG) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
2618831|NCT01968954|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52 by Triglyceride Cut-off|Percent change from baseline in fasting LDL-C among participants with TG cut-off of <200 mg/dL and >=200 mg/dL (2.26 mmol/L) were reported in this outcome measure.|Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
2618832|NCT01968954|Secondary|Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Week 24 and 52||Baseline, Week 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
2618833|NCT01968954|Secondary|Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Mixed Dyslipidemia|Participants with mixed dyslipidemia are defined as TG level greater than or equal to (>=) 200 mg/dL (2.26 mmol/L) at pre-randomization.|Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
2618834|NCT01968954|Secondary|Percent Change From Baseline in Fasting Low-Density Lipoprotein-Cholesterol (LDL-C) at Week 12 in Participants With Primary Hyperlipidemia|Participants with primary hyperlipidemia are defined as participants with triglycerides (TG) level less than (<) 200 milligram per decilitre (mg/dL) (2.26 millimoles per litre [mmol/L]) at pre-randomization.|Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
2618835|NCT01968954|Secondary|Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
2618836|NCT01968954|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
2618837|NCT01968954|Secondary|Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
2618838|NCT01968954|Secondary|Percent Change From Baseline in Non- High Density Lipoprotein-Cholesterol (Non HDL-C) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
2618839|NCT01968954|Secondary|Percent Change From Baseline in Total Cholesterol (TC) at Week 12, 24 and 52||Baseline, Week 12, 24, 52|FAS included all participants who were randomized. Here, ‘n’ signifies those participants who were evaluable at specified time points for each arm.|||percent change||Standard Deviation|Mean
2618840|NCT01968954|Primary|Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"FAS included all participants who were randomized. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
2618851|NCT01968447|Secondary|Vomiting|The effect of low versus normal pCO2 concentrations on the incidence of postoperative vomiting will be studied. The incidence of vomiting is expressed as a precentage of the patients per arm.|from the end of surgery untill 2 hours postoperative||||percentage of patients|||Number
2618841|NCT01968811|Primary|To Evaluate the Performance of the Dressing Kit as Part of a Negative Pressure System in Post Market Clinical Follow-up Settings|"Outcome of each subject was evaluated and presented individually. Questionnaires answered by surgeon at application and removal of the kit; Baseline Overall ease of application of the kit: No. of surgeons rated as; Very easy= 4/Easy=3/Somewhat easy=2/Not easy Overall satisfaction with the kit:No. of surgeons rated as Very satisfied=3/ Satisfied=5/ Unsatisfied=2/ Very unsatisfied=0~Questionnaires were answered by surgeon at application and removal of the kit; Visit 2 Overall ease of application of the kit:No.of surgeons rated as Very easy= 2/Easy=5/Somewhat easy=0/Not easy=1 Overall satisfaction with the kit: No.of surgeons rated as Very satisfied=1/ Satisfied=3/ Unsatisfied=4/ Very unsatisfied=0 Visit 3 Overall ease of application of the kit: No.of surgeons rated as Very easy= 0/Easy=6/Somewhat easy=0/Not easy=0 Overall satisfaction. No of surgeons rated as Very satisfied=0, satisfied=4, unsatisfied=2, very unsatisfied=0"|From 1 to 3 visit, depending on each subject/wound, up to 4 days.|10 patients were enrolled and individually analysed and presented in the study|||number of surgeons|||Number
2618842|NCT01968811|Secondary|- Fascial/Skin Closure of the Open Abdomen|The performance objective is assessed through general application and removal questions after each investigational device handling.|End of treatment, up to 4 days.|No. Analysed for efficacy ITT 10 , PP 9,|||participants|||Number
2618843|NCT01968694|Secondary|Change in Hospital Anxiety and Depression Scale (HADS)|"The Hospital Anxiety and Depression Scale (HADS) consists of 14 items rated from 0-3 and 2 subscales Depression (7 items) and Anxiety (7 items). A higher score on each item represents more of each symptom (i.e., more depression or more anxiety). Each subscale score is the sum of the 7 items from each subscale.~A score of 0-7 = Normal, 8-10=Borderline abnormal (borderline case), and 11-21=Abnormal (case).~Change scores are calculated from baseline (pre-infusion) at 1 day, 1 week, and 1 month post-treatment:~(1 day post-treatment value - BL pre-infusion value)~(1 week post-treatment value - BL pre-infusion value)~(1 month post-treatment value - BL pre-infusion value)"|1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)|In the IV diphenhydramine arm 1 pt is missing HADS scores at 1 week, and 3 pts are missing scores at 1 month. In the IV Lidocaine arm 3 pts are missing HADS scores at 1 month.|||units on a scale||Inter-Quartile Range|Median
2618844|NCT01968694|Secondary|Change in Brief Pain Inventory (BPI): Pain on Average|"The Pain on Average score in the Brief Pain Inventory is rated from 0-10, where 0 is no pain, and 10 is pain as bad as you can imagine.~Change scores are calculated from baseline (pre-infusion) at 1 day, 1 week, and 1 month post-treatment:~(1 day post-treatment value - BL pre-infusion value)~(1 week post-treatment value - BL pre-infusion value)~(1 month post-treatment value - BL pre-infusion value)"|1 day, 1 week, and 1 month post-treatment from BL (pre-infusion)|In the IV diphenhydramine arm 1 pt is missing BPI avg pain score at 1 week, and 2 are missing scores at 1 month. In the IV Lidocaine arm 1 pt is missing a score at 1 day, 1 is missing a score at 1 week, and 4 are missing scores at 1 month.|||units on a scale||Inter-Quartile Range|Median
2618845|NCT01968694|Secondary|Change in Short Form McGill Pain Questionnaire 2|"Short-form McGill Pain Questionnaire version 2 consists of 22 pain items (Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-burning, Aching, Heavy, Tender, Splitting, Tiring-exhausting, Sickening, Fearful, Punishing-cruel, Electric-shock, Cold-freezing, Piercing, Pain caused by light touch, Itching, Tingling or 'pins and needles', and Numbness). Each item is rated on a scale from 0-10, where 0=none, and 10=worst possible pain. The total pain score is the sum of these 22 items, ranging from 0-220.~Change scores are calculated from baseline (pre-infusion) at 30 minutes, 1 week, and 1 month post-treatment:~(30 minutes post-treatment value - BL pre-infusion value)~(1 week post-treatment value - BL pre-infusion value)~(1 month post-treatment value - BL pre-infusion value)"|30 minutes, 1 week, and 1 month post-treatment from BL (pre-infusion)|"participant in the IV diphenhydramine arm is missing SFMPQ total score 1 week post-treatment.~participants in the IV diphenhydramine arm are missing SFMPQ total score 1 month post-treatment.~participants in the IV Lidocaine arm are missing SFMPQ total score 1 month post-treatment."|||units on a scale||Inter-Quartile Range|Median
2618846|NCT01968694|Primary|Change in Visual Analogue Scale (VAS)|"Visual Analogue Scale (VAS) ranges from 0 (no pain) to 10 (the worse imaginable pain).~Change scores are calculated from baseline (pre-infusion) at 15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete:~(15 minutes after start of infusion value - BL pre-infusion value) (30 minutes after start of infusion value - BL pre-infusion value) (30 minutes after infusion complete value - BL pre-infusion value)"|15 minutes after start of infusion, 30 minutes after start of infusion, and 30 minutes after infusion complete from BL (pre-infusion)|"2 participants in the IV Lidocaine arm are missing VAS 30 minutes after infusion started.~3 participants in the IV Lidocaine arm are missing VAS 30 minutes after infusion complete."|||units on a scale||Inter-Quartile Range|Median
2618847|NCT01968551|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Full Analysis Set (FAS) included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study. Participants with available data were analyzed.|||cells/μL||Standard Deviation|Mean
2618848|NCT01968551|Secondary|Change From Baseline in CD4+ Cell Count at Week 24||Baseline; Week 24|Full Analysis Set (FAS) included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study. Participants with available data were analyzed.|||cells/μL||Standard Deviation|Mean
2618849|NCT01968551|Secondary|Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set included participants who (1) were randomized into Cohort 2 and (2) had received at least one dose of study drug during the OL phase of the study.|||percentage of participants|||Number
2618850|NCT01968551|Primary|Percentage of Participants in Each Treatment Arm in Cohort 2 With HIV-1 RNA < 50 Copies/mL at Week 24|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set (FAS) in Cohort 2, included all participants who (1) were randomized to Cohort 2 and (2) received at least 1 dose of study drug during the open-label Phase.|||percentage of participants|||Number
2618852|NCT01968447|Secondary|Nausea|The effect of low versus normal pCO2 concentrations on the incidence of postoperative nausea will be studied. The incidence is expressed as the percentage of people experiencing nausea per arm.|from the end of surgery untill 2 hours postoperative||||percentage of patients|||Number
2618853|NCT01968447|Secondary|Sedation|The effect of low versus normal pCO2 concentrations on postoperative sedation will be studied using the using the validated Leiden Observer's Assessment of Alertness/Sedation (0 (awake) - 6 (unarousable)) scale at 15 min intervals. The data are averaged over time.|from the end of surgery untill 2 hours postoperative||||units on a scale||Standard Deviation|Mean
2618854|NCT01968447|Secondary|Pain Intensity on an 11-point Scale in the Postoperative Period|The effect of low versus normal pCO2 concentrations on postoperative pain will be studied. Painscores are obtained at 15 minutes intervals and are expressed as a number on a 10 point scale (numeric rating scale; 1 (low)-10(maximum)). The data is avaraged over time|from the end of surgery untill 2 hours postoperative||||units on a scale||Standard Deviation|Mean
2618855|NCT01968447|Secondary|Respiratory Function|The effect of low versus normal pCO2 concentrations on the postoperative respiratory function will be studied. Postoperative saturations are obtained at 15 minutes intervals. The data are averaged over time.|from the end of surgery untill 2 hours postoperative||||percentage of oxygen saturation||Standard Deviation|Mean
2618856|NCT01968447|Secondary|Hemodynamics|Hemodynamic conditions are studied during low arterial CO2 concentration and normal arterial CO2 concentration. The average of the measured mean arterial pressures at 15 minute intervals during anesthesia are presented|peroperative||||millimeters of mercury||Standard Deviation|Mean
2618857|NCT01968447|Primary|Surgical Rating Scale|During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The surgeon will score the condition at 15 minute intervals.The values given on the surgical rating scale are averaged and the average value is used in the data analysis.|Peroperative||||units on a scale||Standard Deviation|Mean
2618858|NCT01968434|Secondary|Change in Day Cough Score at End of Study (From D0 to D4)|"A validated cough questionnaire measuring 3 aspects of daytime cough (frequency, severity, bothersomeness) on a 7 point Likert scale was used each evening to rate the passed day, as regards these aspects. The scale rates each parameter from 0 (not at all) to 6 (extremely). Every day of the trial is rated. The last evening of the study (D4) the parents rated the passed day by scoring from 0-6 each of the 3 aspects of day cough. The summed score for all aspects gives the combined day cough score. This score, ranging between 0-18, was subtracted from the sum of all aspects, also ranging between 0-18, form the basal day cough score of the day before enrollment (D0). This change is recorded as change in combined day cough score and it refers to the change from D0 to D4. Negative values of the change indicate an improvement in the condition of the patient."|4 nights (onset of trial Night 1 to Night 4) and 3 days|78 patients were enrolled in the protective syrup Group and 72 in the carbocysteine Group. 3 patients in the protective syrup group and 6 in the carbocysteine group never began the study. 6 patients from the protective syrup group and twelve 11 patients from the carbocysteine group did not answer the questions for the last day.|||change in combined day cough score||Standard Error|Mean
2618859|NCT01968434|Secondary|Change in Night Cough Score at End of Study (From N0 to N4)|"A validated cough questionnaire measuring 5 aspects of night cough (frequency, severity, bothersomeness, child sleep and parents' sleep) on a 7 point Likert scale was used each morning to rate the passed night. The scale rates each parameter from 0 (not at all) to 6 (extremely). Every night of the trial is rated. The morning after the last night of the study (N4) the parents rated the passed night by scoring from 0-6 each of the 5 aspects of night cough. The summed score for all aspects gives the combined night cough score. This score, ranging between 0-30, was subtracted from the sum of all aspects, also ranging between 0-30, form the basal night cough score of the night before enrollment (N0). This change is recorded as change in combined night cough score and it refers to the change from N0 to N4. Negative values of the change indicate an improvement in the condition of the patient."|4 nights (onset of trial Night 1 to Night 4) and 3 days|78 patients were enrolled in the protective syrup Group and 72 in the carbocysteine Group. 3 patients in the protective syrup group and 6 in the carbocysteine group never began the study. 7 patients from the protective syrup group and twelve 12 patients from the carbocysteine group did not answer the questions for the last night.|||change in combined night cough score||Standard Error|Mean
2618860|NCT01968434|Primary|Change in Night Cough Score on First Night of Treatment (From N0 to N1)|"Night cough is most bothersome to the child and family. Cough was measured with a validated questionnaire which asks parents to rate 5 aspects of night cough: frequency, severity, bothersomeness, child sleep and parent sleep according to a 7 point Likert scale, from 0 (not at all) to 6 (extremely). Lower scores indicate a better condition. The morning after the first night of treatment (N1) the parents rated the passed night by scoring from 0-6 each of the 5 aspects of night cough. The sum of scores for all 5 aspects gives the combined night cough score. This score, ranging between 0-30, was subtracted from the sum of all aspects, also ranging between 0-30, form the basal night cough score of the night before enrollment (N0). This change is recorded as change in combined night cough score and it refers to the change from N0 to N1. Negative values of the change indicate an improvement in the condition of the patient."|1 night from before enrollment (N0) to first night after treatment (N1)|the population analyzed are the children who completed the protocol and submitted the complete questionnaire for night and day cough. 78 patients were enrolled in the protective syrup Group and 72 in the carbocysteine Group. 3 patients in the protective syrup group and 6 in the carbocysteine group never began the study.|||change in combined night cough score||Standard Error|Mean
2618861|NCT01968421|Other Pre-specified|Rescue Medication|Use of antibiotics and rapid-acting bronchodilator|1 year|||||||
2618862|NCT01968421|Secondary|Lung Function|Lung function parameters: FEV1, FVC, FEV1/FVC;|1 year|||||||
2618863|NCT01968421|Secondary|Life Quality|(1)St George' s Respiratory Questionnaire (SGRQ); (2)Leicester Cough Questionnaire (LCQ)|1 year|||||||
2618864|NCT01968421|Primary|Bronchiectasis Exacerbation|the proportion of acute exacerbations|1 year||||proportion of acute exacerbations||Standard Deviation|Mean
2618865|NCT01968382|Secondary|Cytokine Data|Changes in cytokine profile across study arms at day 28|28 days|Data not collected||||||
2618866|NCT01968382|Secondary|Time to 50% Drop in Bilirubin|Length of time to a drop in bilirubin of 50% measured in days|180 days|Data not collected||||||
2618868|NCT01968382|Secondary|SOFA Score|SOFA is a single score based on patient status of six different biological systems: respiratory, cardiovascular, hepatic, coagulation, renal, and neurological. Scores range from 0 to 24 with higher scores indicated worse status.|30 days|Data not collected||||||
2618869|NCT01968382|Secondary|Change in Liver Function|Model for end-stage liver disease (MELD) score ranges from 6 to 40 with higher number indicating worse liver function.|90 days||||score on a scale||Standard Deviation|Mean
2618870|NCT01968382|Secondary|Mortality|Number of deaths due to any cause|180 days||||Participants|||Count of Participants
2618871|NCT01968382|Secondary|Lille Model Score|Number of participants who meet Lille criteria indicating failure to respond to treatment|7 days||||Participants|||Count of Participants
2618872|NCT01968382|Secondary|Change in Circulating Endotoxin Levels|Changes in endotoxin levels as measured using a standard blood assay|Baseline, day 28||||ng/mL||Standard Deviation|Mean
2618873|NCT01968382|Secondary|Bowel Gastrointestinal Safety Endpoints|Number of participants who experience diarrhea|30 Days|Data were not collected separately for participants who suffered diarrhea. All gastrointestinal events (including diarrhea) were recorded as generic gastrointestinal events and reported in primary outcome #1.||||||
2618874|NCT01968382|Primary|Other Safety Endpoints|Number of incidents of all other serious adverse events and other adverse events not already assessed as a primary outcome.|30 Days||||Events|||Number
2618875|NCT01968382|Primary|Infection Safety Endpoints|Number of incidents of sepsis.|30 Days||||Incidents|||Number
2618876|NCT01968382|Primary|Combined Kidney, Brain, and Lung Safety Endpoints|Number of incidents of the following: renal failure, encephalopathy or pulmonary compromise.|30 Days||||incidents|||Number
2618877|NCT01968382|Primary|Gastrointestinal Safety Endpoints|Number of events and severity of gastrointestinal events, including nausea, vomiting, and diarrhea|30 Days||||Incidents|||Number
2618878|NCT01968226|Primary|Target to Background Ratio (TBR)|To assess uptake of [F-18]RGD-K5 by carotid plaque with PET/CT imaging (which will be expressed as a target to background ratio (TBR) of the standard uptake value (SUV)) in participants prior to carotid endarterectomy. The TBR of [F-18]RGD-K5 in the plaque will serve as a surrogate marker of plaque inflammation in participants being considered for carotid endarterectomy.|Baseline|no subject analysis done||||||
2618879|NCT01968213|Secondary|Individual Model Parameter Estimates of Rucaparib and Covariates Identification|Concentration summary statistics|Study data collection expected to last for ~7 months.|All patients who are treated with rucaparib with at least one pharmacokinetic (PK) measurement|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2618880|NCT01968213|Secondary|Overall Survival (OS)|The final OS analysis has not been performed yet and will be performed when 70% of the events have been collected.|Continuously for ~5 years after patient enrolls into study.||2021-01-31|01/2021||||
2618881|NCT01968213|Secondary|Time to an 8-point Decrease in the Total Score of the FOSI-18|The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related physical, emotional and treatment-related symptoms, and is based on numerical point scoring of symptoms. The questionnaire is designed to evaluate changes in the total score in individual assessments over time. This study looked at the time to an 8-point reduction in the total score as an indicator of improvement in disease-related symptoms on cancer therapy|Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Study data collection expected to last for ~3 years.||2021-01-31|01/2021||||
2618882|NCT01968213|Secondary|Time to a 4-point Decrease in the Disease-related Symptoms - Physical (DRS-P) Subscale of the FOSI-18|The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related symptoms and is based on numerical point scoring of symptoms. The DRS-P subscale of the questionnaire is specifically designed to assess physical symptoms of ovarian cancer and evaluate changes in the subscale point score in individual assessments over time. This study looked at the time to a 4-point reduction in subscale score as an indicator of improvement in disease-related physical symptoms on cancer therapy.|Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Study data collection expected to last for ~3 years.||2021-01-31|01/2021||||
2618883|NCT01968213|Secondary|Disease Progression According to RECIST v1.1, as Assessed by Independent Radiology Review (IRR), or Death From Any Cause (irrPFS)|To evaluate PFS by RECIST, as assessed by independent radiology review (IRR)|Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Study data collection expected to last for ~3 years.|Intent-to-treat: All patients randomized|||months||95% Confidence Interval|Median
2618884|NCT01968213|Primary|Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS)|Progression-free survival by Investigator (invPFS) is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first. Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).|Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Study data collection expected to last for ~3 years.|Intent-to-treat: All patients randomized|||Months||95% Confidence Interval|Median
2618885|NCT01968135|Secondary|Number of Days to Recurrence of Bleeding After Discontinuation of Therapy||Up to six months||||days||Full Range|Median
2618886|NCT01968135|Secondary|Number of Days Without Bleeding During Therapy||Over the 14 day course of study drug||||days||Full Range|Median
2618887|NCT01968135|Secondary|Number of Days Until Temporary Interruption of Bleeding During Therapy Occurred||over the 14 day course of study drug||||days||Full Range|Median
2618888|NCT01968135|Primary|Cessation of Vaginal Bleeding|Proportion of women in each group who stopped bleeding during therapy and continued to report no bleeding at the end of the 14-day treatment period.|At day 3 of 14 day course of study drug||||percentage of participants|||Number
2618889|NCT01968070|Secondary|PK: Tmax of Multiple Doses LY3127760||Post-last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 Hours|All randomized participants who received at least one dose of study drug for multiple dosing in Part 2 and had evaluable Tmax data.|||hour||Full Range|Median
2618890|NCT01968070|Secondary|PK: Cmax of Multiple Doses LY3127760||Post last dose on Day 28: 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 72, and 168 Hours|All randomized participants who received at least one dose of study drug for multiple dosing in Part 2 and had evaluable Cmax data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2618891|NCT01968070|Secondary|PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC-tau (τ)] of Multiple Doses LY3127760|AUC-tau (τ) where τ is 24-hours for the 20 mg, 60 mg, and 200 mg cohorts, and 12-hours for the 300 mg cohort.|Day 28: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, and 24 Hours|All randomized participants who received at least one dose of study drug for multiple dosing in Part 2 and had evaluable AUC data.|||ng•hr/ml||Geometric Coefficient of Variation|Geometric Mean
2618892|NCT01968070|Secondary|PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760||Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours|All randomized participants who received at least one dose of study drug for the single dose in Part 1 and had evaluable Tmax data.|||Hour||Full Range|Median
2618893|NCT01968070|Secondary|PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760||Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours|All randomized participants who received at least one dose of study drug for the single dose in Part 1 and had evaluable Cmax data.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2618894|NCT01968070|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760||Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours|All randomized participants who received at least one dose of study drug for the single dose in Part 1 and had evaluable AUC data.|||nanograms•hour/milliliter (ng•hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2618895|NCT01968070|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.|Baseline to Study Completion (Up To Day 42)|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2618896|NCT01968057|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib||Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ciclosporin in Period 2) and had PK data to calculate Tmax of baricitinib.|||hours||Full Range|Median
2618897|NCT01968057|Primary|PK: Area Under the Concentration Curve From Time Zero to Infinity [AUC (0-∞)] of Baricitinib||Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ciclosporin in Period 2) and had PK data to calculate AUC (0-∞) of baricitinib.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2618898|NCT01968057|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib||Days 1 and 4: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ciclosporin in Period 2) and had PK data to calculate Cmax of baricitinib.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2618899|NCT01967940|Secondary|Part 2: Change From Baseline in CD4+ Percentage at Week 48||Baseline; Week 48|Participants in the Part 2 Full Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2618900|NCT01967940|Secondary|Part 2: Change From Baseline in CD4+ Percentage at Week 24||Baseline; Week 24|Participants in the Part 2 Full Analysis Set with available data were analyzed.|||percentage change||Standard Deviation|Mean
2618901|NCT01967940|Secondary|Part 2: Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Part 2 Full Analysis Set with available data were analyzed.|||cells/μL||Standard Deviation|Mean
2618902|NCT01967940|Secondary|Part 2: Change From Baseline in CD4+ Cell Count at Week 24||Baseline; Week 24|Participants in the Part 2 Full Analysis Set with available data were analyzed.|||cells/μL||Standard Deviation|Mean
2618903|NCT01967940|Secondary|Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Week 48||Baseline; Week 48|Participants in the Part 2 Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2618904|NCT01967940|Secondary|Part 2: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Week 24||Baseline; Week 24|Participants in the Part 2 Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2618905|NCT01967940|Secondary|Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Week 48|The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Part 2 Full Analysis Set|||percentage of participants|||Number
2618906|NCT01967940|Secondary|Part 2: Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24|The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Part 2 Full Analysis Set|||percentage of participants|||Number
2618907|NCT01967940|Secondary|Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 48|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Part 2 Full Analysis Set: participants who enrolled into Part 2 of the study and received at least one dose of study drug in Part 2.|||percentage of participants|||Number
2618908|NCT01967940|Secondary|Part 2: Percentage of Participants With Plasma HIV-1 RNA < 50 Copies/mL as Defined by the FDA Snapshot Analysis at Week 24|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Part 2 Full Analysis Set|||percentage of participants|||Number
2618909|NCT01967940|Secondary|Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event Through Week 48||Up to Week 48|Part 2 Safety Analysis Set|||percentage of participants|||Number
2618910|NCT01967940|Secondary|Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Any Treatment-Emergent Adverse Event Through Week 24||Up to Week 24|Part 2 Safety Analysis Set|||percentage of participants|||Number
2618911|NCT01967940|Secondary|Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities Through Week 48||Up to Week 48|Part 2 Safety Analysis Set|||percentage of participants|||Number
2618912|NCT01967940|Secondary|Part 2: Safety of E/C/F/TAF STR Plus ATV in Participants Who Switched From a Failing Regimen as Assessed by the Percentage of Participants Experiencing Grade 3 or 4 Laboratory Abnormalities Through Week 24||Up to Week 24|Part 2 Safety Analysis Set: participants who enrolled into Part 2 of the study and received at least one dose of study drug in Part 2.|||percentage of participants|||Number
2618913|NCT01967940|Secondary|Part 1: Change From Baseline in Plasma log10 HIV-1 RNA (Copies/mL) at Day 10||Baseline; Day 10|Part 1 Full Analysis Set|||log10 copies/mL||Standard Deviation|Mean
2618914|NCT01967940|Primary|Part 1: Percentage of Participants With Plasma HIV-1 RNA Decreases From Baseline Exceeding 0.5 log10 at Day 10||Day 10|Part 1 Full Analysis Set: participants who enrolled into Part 1 of the study and received at least one dose of study drug in Part 1.|||percentage of participants|||Number
2618915|NCT01967888|Secondary|Number of Serious Treatment Emergent Adverse Events Related to Investigational Product|"Serious Treatment emergent adverse events - possibly, probably and highly probably - related to investigational product are called serious Adverse reactions.~A serious adverse reaction is defined as any untoward medical occurrence with a causal relationship with the administered medicinal product, that at any dose:~Resulted in death~Was life-threatening (ie, the patient was at risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death if it were more severe.)~Required patient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was an important medical event that, based upon appropriate medical judgment, may have jeopardized the patient and may have required medical or surgical intervention to prevent one of the outcomes listed above"|Throughout the study From Day -1 to hospital discharge for all adverse events, and from then to day 365 post-transplantation only for serious adverse events|Safety population: Safety Population consists of all randomized patients. Summarization and analysis of this population were based on treatment received. Patients randomized but not treated were analyzed in the total summary statistics only.|||Number of events|||Number
2618916|NCT01967888|Secondary|Number of Treatment Emergent Adverse Events Related to Investigational Product|"Treatment emergent adverse events - possibly, probably and highly probably - related to investigational product are called Adverse reactions (ADR).~An adverse reaction is defined as any untoward medical occurrence in a patient or clinical investigation patient, which has a causal relationship with the administered medicinal product."|Throughout the study From Day -1 to hospital discharge|Safety Population:Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.|||Number of events|||Number
2618917|NCT01967888|Secondary|Change From Baseline in Post-transplant Aspartate Aminotransferase (AST)|"Data are reported as model estimates over all timepoints.~This safety parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:~baseline; N=50; 52~Day 2 post-transplant; N=49; 51~Day 3 post-transplant; N=47; 50~Day 7 post-transplant; N=47; 50~Day 75 post-transplant; N=44; 47"|Baseline, Days 2, 3, 7, 75±14 after the transplant|Safety population: Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated.|||U/L||Standard Error|Least Squares Mean
2618918|NCT01967888|Secondary|Change From Baseline in Post-transplant Alanine Aminotransferase (ALT)|"Data are reported as model estimates over all timepoints.~This safety parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:~baseline; N=50; 52~Day 2 post-transplant; N=49; 51~Day 3 post-transplant; N=47; 50~Day 7 post-transplant; N=47; 50~Day 75 post-transplant; N=44; 47"|Baseline, Days 2, 3, 7, 75 ±14 after the transplant|Safety Population: Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated.|||U/L||Standard Error|Least Squares Mean
2618919|NCT01967888|Secondary|Time-to-peak C-peptide at Day 365 After the Transplant|The time to peak value in minutes will be computed as the time of the peak value (HH:MM on a 24-hour clock) minus the end time of the mixed meal (HH:MM on a 24-hour clock) as recorded on the mixed meal tolerance test CRF.|Day 365±14 after the transplant|ITT Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.|||minutes||Standard Deviation|Mean
2618920|NCT01967888|Secondary|Time-to-peak C-peptide at Day 75 After the Transplant|The time-to-peak value in minutes was computed as the time of the peak value (HH:MM on a 24-hour clock) minus the end time of the mixed meal (HH:MM on a 24-hour clock) as recorded on the mixed meal tolerance test Case Report Form.|day 75±14 and day 365±14 after the transplant|ITT Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.|||minutes||Standard Deviation|Mean
2618921|NCT01967888|Secondary|Peak C-peptide at Day 365 After the Transplant|Peak C-peptide (C-P) is a known predictor of Type 1 Diabetes.|Day 365±14 after the transplant|ITT Population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.|||ng/mL||Standard Deviation|Mean
2618922|NCT01967888|Secondary|Peak C-peptide at Day 75 After the Transplant|Peak C-peptide (C-P) is a known predictor of Type 1 Diabetes.|Day 75±14 after the transplant|ITT population: ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.|||ng/mL||Standard Deviation|Mean
2618923|NCT01967888|Secondary|Cumulative Number of Diabetic Ketoacidosis-related Events|"A diabetic ketoacidosis event is defined as the presence of:~hyperglycemia (blood glucose >200 mg/dL);~pH <7.3 or HCO3 <15;~ketones positive in the serum or urine."|from day 75±14 to day 365±14 after the transplant|Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.|||number of events||Standard Deviation|Mean
2618924|NCT01967888|Secondary|Cumulative Number of Episodes of Documented Symptomatic Hypoglycemia From Day 75±14 to Day 365±14 After the Transplant|"The following definition applies:~- Documented symptomatic hypoglycemia = An event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <70mg/dL."|from day 75±14 to day 365±14 after the transplant|Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.|||number of episodes||Standard Deviation|Mean
2618925|NCT01967888|Secondary|Cumulative Number of Episodes of Documented Asymptomatic Hypoglycemia From Day 75±14 to Day 365±14 After the Transplant|"The following definition applies:~- Asymptomatic hypoglycemia = An event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration <70mg/dL."|from day 75±14 to day 365±14 after the transplant|Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.|||number of episodes||Standard Deviation|Mean
2618926|NCT01967888|Secondary|Proportion of Patients by Steatorrhea Severity at Day 365±14 After the Transplant|"Levels of steatorrhea severity (evaluated in the 4 weeks prior to day 75±14 and 365±14), are defined as:~No steatorrhea;~Steatorrhea few times per week;~Steatorrhea daily;~Stool incontinence."|day 365±14 after the transplant|Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.|||percentage of participants||95% Confidence Interval|Number
2618927|NCT01967888|Secondary|Proportion of Patients by Steatorrhea Severity at Day 75±14 After the Transplant|"Levels of steatorrhea severity (evaluated in the 4 weeks prior to day 75±14 and 365±14), are defined as:~No steatorrhea;~Steatorrhea few times per week;~Steatorrhea daily;~Stool incontinence."|day 75±14 after the transplant|Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.|||percentage of participants||95% Confidence Interval|Number
2618928|NCT01967888|Secondary|Proportion of Patients Falling Into One of the Following Malnutrition Risk Levels (Poor Prognosis, Significant Risk, Increased Risk, Normal) According to Pre-albumin Level at Day 365±14 After the Transplant|"Malnutrition risk levels are defined as:~Poor prognosis = pre-albumin level <5.0 mg/dL~Significant risk = pre-albumin level 5.0 to 10.9 mg/dL~Increased risk = pre-albumin level 11.0 to 15.0 mg/dL~Normal = pre-albumin level > 15.0 (up to 35.0) mg/dL"|day 365±14 after the transplant|Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.|||percentage of participants||95% Confidence Interval|Number
2618929|NCT01967888|Secondary|Proportion of Patients Falling Into One of the Following Malnutrition Risk Levels (Poor Prognosis, Significant Risk, Increased Risk, Normal) According to Pre-albumin Level at Day 75±14 After the Transplant|"Malnutrition risk levels are defined as:~Poor prognosis = pre-albumin level <5.0 mg/dL~Significant risk = pre-albumin level 5.0 to 10.9 mg/dL~Increased risk = pre-albumin level 11.0 to 15.0 mg/dL~Normal = pre-albumin level > 15.0 (up to 35.0) mg/dL"|day 75±14 after the transplant|Safety Population consists of all randomized patients. Summarization and analysis of this population was based on treatment actually received. Patients randomized but not treated were analyzed in the total summary statistics only.|||percentage of patients||95% Confidence Interval|Number
2618930|NCT01967888|Secondary|Incidence and Severity of Adverse Events and Serious Adverse Events Throughout the Study|"The percentages of patients with any treatment emergent adverse events (TEAE, serious and non serious) and with serious TEAE by severity are presented.~Patients with multiple events within a particular system organ class or preferred term were counted only under the category of their most severe event within that system organ class or preferred term.~A serious AE was defined as any untoward medical occurrence that at any dose:~Resulted in death~Was life-threatening (ie, the patient was at risk of death at the time of the event)~Required inpatient hospitalization or prolongation of existing hospitalization~Resulted in persistent or significant disability/incapacity~Was a congenital anomaly/birth defect~Was an important medical event that, based upon appropriate medical judgment, may have jeopardized the patient and may have required medical or surgical intervention to prevent one of the outcomes listed above"|up to day 365±14 after the transplant|"ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.~Eligible patients are included in this population whether or not they receive IAT."|||percentage of patients|||Number
2618983|NCT01967277|Primary|Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.|At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.|baseline and 17 weeks||||terminal hairs||Standard Deviation|Mean
2618931|NCT01967888|Secondary|Proportion of Patients With an HbA1c <6.5% at Day 365±14 After the Transplant AND Free of Severe Hypoglycemic Events From Day 75±14 to Day 365±14 After the Transplant Inclusive|"Percentage of patients with an HbA1c <6.5% at day 365±14 after the transplant AND free of severe hypoglycemic events from day 75±14 to day 365±14 after the transplant inclusive.A severe hypoglycemic event is defined as an event with one of the following symptoms: memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure, loss of consciousness, or visual symptoms, in which the subject was unable to treat him/herself and which was associated with either a blood glucose level <54mg/dL or prompt recovery after oral carbohydrate, i.v. glucose, or glucagon administration."|from day 75±14 to day 365±14 after the transplant|"ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.~Eligible patients are included in this population whether or not they receive IAT."|||percentage of participants||95% Confidence Interval|Number
2618932|NCT01967888|Secondary|Cumulative Number of Severe Hypoglycemic Events From Day 75±14 to Day 365±14 After the Transplant|"A severe hypoglycemic event is defined as an event with one of the following symptoms: memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure, loss of consciousness, or visual symptoms, in which the subject was unable to treat him/herself and which was associated with either a blood glucose level <54mg/dL or prompt recovery after oral carbohydrate, i.v. glucose, or glucagon administration."|from day 75±14 to day 365±14 after the transplant|"ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.~Eligible patients are included in this population whether or not they receive IAT."|||number of events||Standard Deviation|Mean
2618933|NCT01967888|Secondary|Proportion of Patients With an HbA1c <6.5% at Day 365±14 After the Transplant|Percentage of patients with a glycated haemoglobin (HbA1c) <6.5% at day 365±14 after the transplant.|day 365±14 after the transplant|"ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.~Eligible patients are included in this population whether or not they receive IAT"|||percentage of participants||95% Confidence Interval|Number
2618934|NCT01967888|Secondary|β-cell Function at Day 365±14 After the Transplant|"This variable is assessed by β-score (assessment of β-cell function after islet transplantation). The total score is calculated on a 0-8 scoring system (higher is a better outcome) that gives 0-2 points each for glucose, HbA1c, stimulated C-peptide and insulin requirement subscales.~The higher the total score the better the outcome.~Fasting (or before breakfast) plasma glucose (mg/dL) : ≤99, Score 2; 100-124, Score 1; ≥ 125, Score 0 (the higher the subscore the better the outcome)~HbA1c (%): ≤6.1, Score 2; 6.2-6.9, Score 1; ≥ 7.0, Score 0 (the higher the subscore the better the outcome)~Daily average (previous week) insulin (IU/kg/day): ---, Score 2; 0.01-0.24, Score 1; ≥ 0.25, Score 0 (the higher the subscore the better the outcome)~Stimulated C-peptide (ng/mL): ≥ 0.9, Score 2; 0.3-0.89, Score 1; ≤0.3, Score 0 (the higher the subscore the better the outcome)"|day 365±14 after the transplant|"ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.~Eligible patients are included in this population whether or not they receive IAT."|||score on a scale||Standard Deviation|Median
2618935|NCT01967888|Secondary|β-cell Function at Day 75±14 After the Transplant|"This variable is assessed by β-score (assessment of β-cell function after islet transplantation). The total score is calculated on a 0-8 scoring system (higher is a better outcome) that gives 0-2 points each for:~fasting plasma glucose,~HbA1c,~stimulated C-peptide~insulin requirement subscales. The higher the total score, the better the outcome.~Fasting (or before breakfast) plasma glucose (mg/dL) : ≤99, Score 2; 100-124, Score 1; ≥ 125, Score 0 (the higher the subscore the better the outcome)~HbA1c (%): ≤6.1, Score 2; 6.2-6.9, Score 1; ≥ 7.0, Score 0 (the higher the subscore the better the outcome)~Daily average (previous week) insulin (IU/kg/day): ---, Score 2; 0.01-0.24, Score 1; ≥ 0.25, Score 0 (the higher the subscore the better the outcome)~Stimulated C-peptide (ng/mL): ≥ 0.9, Score 2; 0.3-0.89, Score 1; ≤0.3, Score 0 (the higher the subscore the better the outcome)"|day 75±14 after the transplant|"ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.~Eligible patients are included in this population whether or not they receive IAT."|||score on a scale||Standard Deviation|Mean
2618936|NCT01967888|Secondary|Time Course From Basal to 240 Min of Insulin Derived From the Mixed Meal Tolerance Test (MMTT) at Day 365±14 After the Transplant|"Data are reported as model estimates over all timepoints.~This parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:~basal; N=34; 41 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal)~15 min; N=34; 41~30 min; N=34; 41~60 min; N=34; 41~90 min; N=34; 41~120 min; N=34; 41~180 min; N=33; 41~240 min; N=33; 40"|day 365±14 after the transplant|ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.|||UIU/mL||Standard Error|Least Squares Mean
2618937|NCT01967888|Secondary|Time Course From Basal to 240 Min of Insulin Derived From the Mixed Meal Tolerance Test (MMTT) at Day 75±14 After the Transplant|"Data are reported as model estimates over all timepoints.~This parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:~basal; N=43; 48 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).~15 min; N=43; 47~30 min; N=41; 47~60 min; N=41; 47~90 min; N=41; 47~120 min; N=42; 47~180 min; N=41; 47~240 min; N=40; 44"|day 75±14 after the transplant|ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.|||UIU/mL||Standard Error|Least Squares Mean
2618938|NCT01967888|Secondary|Time Course From Basal to 240 Min of C-peptide Derived From the Mixed Meal Tolerance Test (MMTT) at Day 365±14 After the Transplant|"Data are reported as model estimates over all timepoints.~This parameters was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:~basal; N=33; 41 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).~15 min; N=34; 41~30 min; N=34; 41~60 min; N=33; 41~90 min; N=34; 41~120 min; N=34; 41~180 min; N=33; 40~240 min; N=33; 41"|day 365±14 after the transplant|ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.|||ng/mL||Standard Error|Least Squares Mean
2618939|NCT01967888|Secondary|Time Course From Basal to 240 Min of C-peptide Derived From the Mixed Meal Tolerance Test (MMTT) at Day 75±14 After the Transplant|"Data are reported as model estimates over all timepoints.~This parameters was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:~basal; N=44; 48 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).~15 min; N=43; 47~30 min; N=41; 47~60 min; N=42; 47~90 min; N=42; 47~120 min; N=42; 47~180 min; N=41; 47~240 min; N=40; 44"|day 75±14 after the transplant|ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.|||ng/mL||Standard Error|Least Squares Mean
2618940|NCT01967888|Secondary|Time Course From Basal to 240 Min of Glucose Derived From the Mixed Meal Tolerance Test (MMTT) at Day 365±14 After the Transplant|"Data are reported as model estimates over all timepoints~This parameters was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:~basal; N=34; 42 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).~15 min; N=34; 41~30 min; N=34; 41~60 min; N=34; 41~90 min; N=34; 41~120 min; N=34; 41~180 min; N=33; 41~240 min; N=33; 41"|day 365±14 after the transplant|ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.|||mg/dL||Standard Error|Least Squares Mean
2618941|NCT01967888|Secondary|Time Course From Basal to 240 Min of Glucose Derived From the Mixed Meal Tolerance Test (MMTT) at Day 75±14 After the Transplant|"Data of this outcome are reported as model estimates over all timepoints.~This parameter was assessed at the following timepoints on the following numbers of patients for Reparixin and placebo, respectively:~basal; N=43; 48 (Basal is: 2 basal samples taken separately between -20 to 0 minutes before the meal followed by samples through 240 minutes after the meal).~15 min; N=42; 46~30 min; N=40; 46~60 min; N=40; 46~90 min; N=40; 46~120 min; N=41; 46~180 min; N=40; 46~240 min; N=39; 44"|day 75±14 after the transplant|"ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.~Eligible patients are included in this population whether or not they receive IAT"|||mg/dL||Standard Error|Least Squares Mean
2618942|NCT01967888|Secondary|Average Daily Insulin Requirements at Day 365±14 After the Transplant|Daily insulin is reported as IU/kg and intake averaged over the previous week.|day 365±14 after the transplant|"ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.~Eligible patients are included in this population whether or not they receive IAT."|||IU/kg/day||Standard Deviation|Mean
2618943|NCT01967888|Secondary|Average Daily Insulin Requirements at Day 75±14 After the Transplant|Daily insulin is reported as IU/kg and intake averaged over the previous week.|day 75±14 after the transplant|"ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.~Eligible patients are included in this population whether or not they receive IAT."|||IU/kg/day||Standard Deviation|Mean
2618944|NCT01967888|Secondary|Area Under the Curve (AUC) for the Serum C-peptide Level at Day 365±14 After the Transplant|AUC for the serum C-peptide level is calculated during the first 4 hours of a mixed meal tolerance test (MMTT), normalized by the number of Islet Equivalent (IEQ)/kg|day 365±14 after the transplant|"ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.~Eligible patients are included in this population whether or not they receive IAT"|||(ng/mL)/(IEQ/kg)*1000||Standard Deviation|Mean
2618945|NCT01967888|Secondary|Area Under the Curve (AUC) for the Serum C-peptide Level at Day 75±14 After the Transplant|AUC for the serum C-peptide level is calculated during the first 4 hours of an MMTT, normalized by the number of Islet Equivalent (IEQ)/kg|day 75±14 after the transplant|"ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.~Eligible patients are included in this population whether or not they receive IAT."|||(ng/mL)/(IEQ/kg)*1000||Standard Deviation|Mean
2618946|NCT01967888|Primary|Percentage of Patients Who Were Insulin Independent After Islet Autotransplantation (IAT) at Day 365±14 Days After Transplant.|"Insulin-independence is defined as freedom from the need to take exogenous insulin for 14 or more consecutive days, with adequate glycemic control, as defined by:~a glycated hemoglobin (HbA1c) level <6.5%;~fingerstick fasting blood glucose not exceeding 126 mg/dL more than three times in the past week (based on a minimum of one daily measurement;~a 2 hour post-prandial blood glucose not exceeding 180 mg/dL more than four times in the past week (based on a minimum of one daily measurement);~a laboratory fasting glucose in the non-diabetic range (<126 mg/dL)."|day 365±14 after the transplant|"ITT Population consists of all patients who were randomized and received the Investigational Product (either reparixin or placebo). Summarization and analysis of this population is based on randomized treatment, regardless of treatment actually received.~Eligible patients are included in this population whether or not they receive IAT."|||Percentage of participants|||Number
2618947|NCT01967836|Secondary|Clinic Nurse Observation of Subjects, Who Used Intervention Device, at the Next Clinic Visit|"The secondary outcomes of the study are clinic nurse observed problems. Percentage of yes responses of nurse observations of site at clinic visit~Line dressing intact (Yes) is in place (reporting on 20 lines on 28 RN observations)~Absence (No) of local skin irritation,~Dislodgement of the IV line/needle (No) with the IV site upon subject return to the clinic and verification by the subject ."|Inspection of central line site and dressing upon return to schduled clinic visit up to 30 days|Nurse questionnaire evaluation forms were completed relative to subjects questionnaires being returned at next clinic visit|||percentage of observation|Nurse Observation of IV Site||Number
2618948|NCT01967836|Primary|Patient Satisfaction Mean on a 0-10 Likert Scale on the Use of Glad Press 'n Seal During Showering. 40 Subjects Reports.|0 Not at all satisfied 10 Very satisfied|Reported afer each subject showering survey completion||||units on a scale||Standard Deviation|Mean
2618949|NCT01967836|Primary|Patient Subject Questionnaire Post Shower Evaluation|"Percentage of responses to evaluation questions (Percentage reported are yes responses) for the following questions. 40 surveys were returned from 11 patient subjects.~Did you need assistance to place the Glad Press 'n Seal to your IV area?~Was the area covered by the Glad Press 'n Seal dry after taking it off?~Was the dressing covering your IV undamaged after taking off the Glad Press 'n Seal?~Did you feel the IV Line was accidentally pulled at all with the use of the Glad Press 'n Seal?~Likert Scale response to the following question On a scale of 0 (would not use) to 10 (would continue to use) how satisfied were you in using Glad Press n Seal?"|complete one evaluation after each shower when using product|10 oncology and 1 ambulatory subjects returned 39 evaluation forms for primary analysis|||percentage of yes responses|||Number
2618950|NCT01967784|Primary|Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Quadrivalent Influenza Vaccine|Solicited Injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Injection site Grade 3 (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, Induration, and Ecchymosis, ≥ 50 mm. Injection site Grade 3 (12 to 17 years): Pain, Significant; prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, > 100 mm. Systemic Grade 3 (9 to 17 years): Fever, ≥ 39.0°C; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were analyzed in the Safety Analysis Set.|||Percentage of participants|||Number
2618951|NCT01967784|Primary|Geometric Mean Titers Ratios of Influenza Antibodies Following Vaccination With a Quadrivalent Influenza Vaccine|Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titers ratios were analyzed in the Immunogenicity Analysis Set.|||Titers ratio||95% Confidence Interval|Geometric Mean
2618952|NCT01967784|Primary|Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Quadrivalent Influenza Vaccine|Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as participants with a pre-vaccination titer <10 (1/dil) to a post-vaccination titer ≥40 (1/dil) or significant increase was defined as participants with a pre-vaccination titer ≥10 (1/dil) and ≥4-fold increase of the titer.|Day 21 post-vaccination|Seroconversion or significant increase in influenza antibody titers was analyzed in the Immunogenicity Analysis Set.|||Percentage of participants|||Number
2618953|NCT01967784|Primary|Percentage of Participants With Seroprotection Before and Following Vaccination With a Quadrivalent Influenza Vaccine|Immunogenicity of the Quadrivalent Influenza vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 (pre-vaccination) and on Day 21 post-vaccination.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroprotection was analyzed in the Immunogenicity Analysis Set.|||Percentage of participants|||Number
2618954|NCT01967784|Primary|Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Quadrivalent Influenza Vaccine|Immunogenicity of the Quadrivalent Influenza Vaccine virus was evaluated using the hemagglutination inhibition (HAI) technique.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Geometric mean titers were analyzed in the Immunogenicity Analysis Set.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2618955|NCT01967732|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of THS 2.2, CC and NNS|"Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares means are provided."|3 days|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.|||h*ng/mL||95% Confidence Interval|Least Squares Mean
2618956|NCT01967732|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NNS|"Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares means are provided."|3 days|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.|||ng/mL||95% Confidence Interval|Least Squares Mean
2618957|NCT01967719|Primary|Area Under the Plasma Nicotine Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS 2.2, mCC and NNS|"Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares means are provided."|3 days|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.|||h*ng/mL||95% Confidence Interval|Least Squares Mean
2619010|NCT01966978|Secondary|Composite End-point|Percentage of participants with glycosylated Hemoglobin A1c (A1c)<8% AND no documented severe hypoglycemia (<56 mg/dL) during the study AND no significant weight gain (>3% from baseline)|Week 0 (Randomization) , Week 26||||percentage of participants|||Number
2618958|NCT01967719|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS 2.2, mCC and NNS|"Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares (geometric LS) means are provided."|3 days|Pharmacokinetics (PK) populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.|||ng/mL||95% Confidence Interval|Least Squares Mean
2618959|NCT01967706|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS, mCC and NRT|"T0 = start of single product use.~Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares means are provided."|Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.|||ng*h/mL||95% Confidence Interval|Least Squares Mean
2618960|NCT01967706|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS, mCC and NRT|"T0 = start of single product use.~Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares means are provided."|Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.|||ng/mL||95% Confidence Interval|Least Squares Mean
2618961|NCT01967641|Secondary|Pain Measurement|The primary pain measure was the Pain Assessment and Documentation Tool (PADT). Total score ranging from 0-11 reported. Higher score considered indicative of more pain. Lower score is indicative of less pain.|assessed twice weekly during course of 19 weeks or length of participation, only screening and last assessment reported.||||units on a scale||Standard Deviation|Mean
2618962|NCT01967641|Secondary|Number of Participants Abstinent From Opioids|Relapse was number of participants with opioid-negative urine toxicology in last week of study participation.|at week 19 or length of study participation||||participants|||Number
2618963|NCT01967641|Primary|Number of Participants Retained in Study|Retention was number of participants retained at study end (Week 19).|week 19||||participants|||Number
2618964|NCT01967628|Primary|Antimicrobial Activity by Airway Surface Liquid (ASL) as Measured by Relative Light Units (RLU)|We investigated the effect of vitamin D3 supplementation on airway surface liquid antimicrobial activity using a bioluminescent bacterial challenge. We challenged airway surface liquid samples with bioluminescent bacteria and measured live bacteria by relative light units (RLU) after 2 minutes as a surrogate of antimicrobial activity. We interpreted a reduction in live bacteria after challenge in relative light units as increased antimicrobial activity|3 months||||Relative Light Units (RLU)||95% Confidence Interval|Mean
2618965|NCT01967550|Primary|Measure: Pain On Movement (POM)|POM will be assessed by subject on a 100 mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 with higher score indicating higher levels of pain.|2 weeks|The modified ITT (mITT) population excludes subjects in the ITT population who were incorrectly instructed by the investigator to treat only one knee. The mITT population is primary for the analysis of efficacy.|||units on a scale||Standard Deviation|Mean
2618966|NCT01967537|Secondary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 50 months and 17 days.||||Participants|||Count of Participants
2618967|NCT01967537|Secondary|The Number of Tumors Identified in Participants by the Radiation Detector During Radio-guided Surgery Using 68Gallium-DOTATATE|Radio-guided surgery in neuroendocrine tumors using 68Gallium-DOTATATE was performed to detect tumors in the stomach and small bowel neuroendocrine tumors, pancreas, metastatic sites to lymph nodes and liver, and pheochromocytoma or paraganglioma. The number of tumors identified by the radiation detector were assessed.|Radio-guided surgery, up to 2 hours|As of 02.14.2018 when the analysis was performed, 44/326 subjects required surgical intervention with intraoperative radiation detector and thus were analyzed for the number of tumors identified. 282 participants were not surgical candidates and did not receive intraoperative dose of 68 Gallium-DOTATATE and did not have radiation detector used.|||Number of tumors|||Number
2618968|NCT01967537|Secondary|Median Radioactivity of Tumors With High Expression of Somatostatin Receptor 2 Compared to Tumors With Intermediate Expression of Somatostatin Receptor 2|High expression of somatostatin receptor 2 (SSTR2) is based on the intensity grading on immunohistochemistry. High SSTR2 expression may be associated with well-differentiated tumor and high avidity on DOTATATE scan, compared to intermediate or low expression of SSTR that can be seen in poorly differentiated and often aggressive neuroendocrine tumors. Because the correlation can only be from the comparison of preoperative DOTATATE and the tumors that were removed, it is a one time analysis. Subsequent DOTATATE studies are for surveillance and follow up for disease progression or recurrence.|During PET Scan, up to 2 hours annually|As of 12/22/14 when the analysis was performed, 12/140 subj. required surgical intervention with intraoperative radiation detector & thus were analyzed. 12 subj. had their tumors analyzed for the expression of SSTR, 126 subj. were not surgical candidates or did not receive intraoperative dose of 68Gallium-DOTATATE & did not have radiation detector.|||Tumor to background ratio||Full Range|Median
2619011|NCT01966978|Primary|Mean Change From Randomization in A1c at Week 26|Change in glycosylated Hemoglobin A1c (A1c) from randomization to 26 weeks of therapy|Baseline and Week 26||||Percentage of glycosylated hemoglobin||95% Confidence Interval|Mean
2618969|NCT01967537|Secondary|Tumor Volume of Neuroendocrine Tumors Assessed by the 68Gallium-DOTATATE Scan|Participants were scanned using the 68Gallium-DOTATATE Scan. Tumor volume more than 7ml is associated with shorter time to disease progression. Tumor volume more than 36 ml is associated with shorter disease specific survival.|During radioguided surgery, up to 2 hours|184/341 participants were analyzed because 52 withdrew consent and 2 refused treatment, 22 did not have a diagnosis of neuroendocrine tumor, and 81 had no 68Ga-DOTATATE uptake and were excluded.|||ml||Full Range|Median
2618970|NCT01967537|Secondary|Mean Radiation Activity Between Low Grade and Intermediate Grade Neuroendocrine Tumor|The radioactivity was assessed using intraoperative radiation detector following the 68Gallium-DOTATATE injection. Low grade neuroendocrine tumors is defined as tumors with slow cell division determined in histology. Low grade tumors is associated with the best outcome. Intermediate grade tumor is defined as the tumor with medium (3-20%) rate of actively dividing cells and is associated with less favorably outcome.|During radioguided surgery, up to 2 hours|As of 12/22/14 when the analysis was performed, 14/140 subjects required surgical intervention with intraoperative radiation detector and thus were analyzed. 126 participants were not surgical candidates or did not receive intraoperative dose of 68Gallium-DOTATATE and did not have radiation detector.|||511KeV count per ten seconds||Standard Deviation|Mean
2618971|NCT01967537|Primary|Number of Lesions Detected Using the 68Gallium-DOTATATE Positron Emission Tomography (PET/Computed Tomography (CT)) Scan|Patients with neuroendocrine tumors (NETs) were scanned with the 68Gallium-DOTATATE Positron Emission Tomography (PET/Computed Tomography (CT)) and the number of lesions detected are collected.|During PET Scan, up to 2 hours annually for up to 5 years|Analysis was performed in the initial 131/341 participants scanned because 52 withdrew consent and 2 refused treatment. Subsequent scans in the remaining 156 participants were used to assess secondary objectives.|||Number of lesions|||Number
2618972|NCT01967433|Secondary|24 Hour Follow up Amnesia Score|Patient were also asked to rate amnesia on a 10 point scale 24 after discharge. minimum= 0 (worse) maximum =10 (better)|At about 24 after the procedure||||score on a 10 point point scale||Standard Deviation|Mean
2618973|NCT01967433|Secondary|Dosage of Midazolam|Moderate sedation (using the American Society of Anesthesiologists definition of maintaining purposeful response to verbal or tactile stimulation, adequate ventilation requiring no airway protection, and maintenance of cardiovascular function) was then achieved using incremental doses of the combination of intravenous midazolam (1 mg) and fentanyl (25 μg) given every 2 to 3 minutes. To minimize any crossover, additional diphenhydramine was not permitted.|From induction (first dose of sedative) to end of procedure||||mg||Standard Deviation|Mean
2618974|NCT01967433|Secondary|24 Hour Follow up Pain Score|"At 24 hr follow up patients were asked to rate the level of pain during the procedure using 10 point scale.~10 point visual analogue scale minimum= 0 (better) maximum =10 (worse)"|About 24 hours after the procedure||||score on a scale||Standard Deviation|Mean
2618975|NCT01967433|Secondary|Number of Participants With Adverse Events|Following adverse events will be recorded: (1)Hypoxia defined as O2 saturation less than 89% lasting for more than 30 seconds, (2)hypotension defined as systolic BP less than 90 mmhg and (3)use of reversal agents i.e Naloxone or Flumazenil|From induction (first dose of sedative) to discharge||||Participants|||Count of Participants
2618976|NCT01967433|Secondary|Duration of Procedure|Induction period (time from first dose of fentanyl to scope insertion), procedural time (time from scope insertion to scope out), and recovery time (time from scope out to discharge) were recorded by the nursing staff in their standard documentation.|Time from induction (first dose of sedative) to discharge||||minutes||Standard Deviation|Mean
2618977|NCT01967433|Secondary|Quality of Sedation|"Quality of sedation will be accessed by the nurse and the physician at the end of procedure.~Name: 10 point visual analogue scale Minimum score: 1 (worse) Maximum score: 10 (better)"|During the colonoscopy and 24 hours after discharge||||score on a scale||Standard Deviation|Mean
2618978|NCT01967433|Primary|Dosage of Fentanyl|Moderate sedation (using the American Society of Anesthesiologists definition of maintaining purposeful response to verbal or tactile stimulation, adequate ventilation requiring no airway protection, and maintenance of cardiovascular function) was then achieved using incremental doses of the combination of intravenous midazolam (1 mg) and fentanyl (25 μg) given every 2 to 3 minutes. To minimize any crossover, additional diphenhydramine was not permitted.|From induction (first dose of sedative) to end of procedure||||(μg)||Standard Deviation|Mean
2618979|NCT01967342|Secondary|Patient Global Impression of Change (PGIC), Pain Intensity|"The Patient Global Impression of Change (PGIC) assesses self-perceived changes in pain intensity. Scores were dichotomized such that responses of very much better and much better were recoded as 1 and all other responses were coded as zero, as performed by Cherkin et al. (2016), in order to indicate clinically meaningful improvement on pain intensity. The following outcome measure data table reports the number of participants per group reporting clinically meaningful improvement at post-treatment (10-weeks) and follow-up (6-months)."|Retrospective self-report at post-treatment (10-weeks) and follow-up (6-months).|Only participants who completed the post-treatment (10-weeks) and follow-up (6-months) assessments were included in the following analyses.|||Participants|||Count of Participants
2618980|NCT01967342|Secondary|Patient Health Questionnaire - 9 (PHQ-9)|Depressive symptoms were assessed using the Patient Health Questionnaire-9 (PHQ-9; range 0-27; higher scores indicate greater severity).|Post-treatment (10-weeks) and follow-up (6 months)|The predicted mean estimates were based on latent growth modeling from mplus using all participants.|||units on a scale||Standard Deviation|Mean
2618981|NCT01967342|Secondary|Brief Pain Inventory-Interference (BPI-Interference)|Brief Pain Inventory-Intensity indicates level of pain interference. Higher scores (range 0-10) reflect higher perceived pain interference.|Post-treatment (10-weeks) and follow-up (6 months)|The predicted mean estimates were based on latent growth modeling from mplus using all participants.|||units on a scale||Standard Deviation|Mean
2618982|NCT01967342|Primary|Brief Pain Inventory-Intensity (BPI-Intensity)|Brief Pain Inventory-Intensity indicates level of pain intensity. Higher scores (range 0-10) reflect higher perceived pain severity.|Post-treatment (10-weeks) and follow-up (6 months)|The predicted mean estimates were based on latent growth modeling from mplus using all participants.|||units on a scale||Standard Deviation|Mean
2619091|NCT01966380|Primary|Absorption of Wound Exudates.|Absorption capacity measured subjectively: NA/POOR/GOOD/VERY GOOD/EXCELLENT|2-3 weeks|Participants served as their own controll, those the total amount of participants is reflekted in both of the outcome measurements.|||Total no. assess. in each wounddressing|Participants||Number
2618984|NCT01967277|Primary|Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.|At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.|baseline and 17 weeks||||percent change||Standard Deviation|Mean
2618985|NCT01967225|Secondary|Reduction Ratio of the Lesion Size From the Screening Visit to Day 3 to Day 4 Visit (Only Skin and Soft Tissue Infection [SSTI])|Lesion size was measured by the masked investigators of erythema, edema, or induration whichever is largest. Reduction ratio (%) = 100 * (the post baseline value - baseline value) / baseline value. Negative values represent reduction of lesion size compared to baseline.|Baseline and Day 3/4, Day 5/13, EOT, TOC|This outcome measure was analyzed based on the microbiological evaluable population-ME-MRSA analysis set. The ME-MRSA consisted of clinical evaluable population at test of Cure (CE-TOC) analysis population who had an MRSA isolated as pathogen at the baseline. Data of SSTI target participants were reported for this outcome measure.|||Percentage||Standard Deviation|Mean
2618986|NCT01967225|Secondary|Change of the Lesion Size From the Screening Visit by Visit (Only Skin and Soft Tissue Infection [SSTI])|Lesion size was measured by the masked investigators of erythema, edema, or induration whichever is largest.|Multiple time points up to 7-14 days after the end of treatment|This outcome measure was analyzed based on the microbiological evaluable population-ME-MRSA analysis set. The ME-MRSA consisted of clinical evaluable population at test of Cure (CE-TOC) analysis population who had an MRSA isolated as pathogen at the baseline. Data of SSTI target participants were reported for this outcome measure.|||cm^2||Standard Deviation|Mean
2618987|NCT01967225|Secondary|Microbiological Response at End of Treatment (EOT)|Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.|7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration|This outcome measure was analyzed based on the microbiological evaluable population-methicillin-resistant Staphylococcus aureus (ME-MRSA) analysis set. The ME-MRSA consisted of clinical evaluable population at test of Cure (CE-TOC) analysis population who had an MRSA isolated as pathogen at the baseline.|||Percentage of participants|||Number
2618988|NCT01967225|Secondary|Clinical Response at End of Treatment Visit (EOT)|Clinical response was evaluated by the masked investigator as effective, ineffective and indeterminate on the basis of the clinical symptoms/findings, vital sign and laboratory data from screening period to each evaluation point. Measurements for the assessment of clinical response included body temperature, pulse/heart rate, respiration rate, and white blood cell or band cell count.|7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia from the study drug administration|This outcome measure was analyzed based on the microbiological evaluable population-methicillin-resistant Staphylococcus aureus (ME-MRSA) analysis set. The ME-MRSA consisted of clinical evaluable population at test of Cure (CE-TOC) analysis population who had an MRSA isolated as pathogen at the baseline.|||Percentage of participants|||Number
2618989|NCT01967225|Primary|Microbiological Response at Test of Cure (TOC)|Microbiological response was assessed in accordance with the Guidance for the method of microbiological assessment by Japanese Chemotherapy Society.|7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia|This outcome measure was analyzed based on the microbiological evaluable population-methicillin-resistant Staphylococcus aureus (ME-MRSA) analysis set. The ME-MRSA consisted of clinical evaluable population at test of Cure (CE-TOC) analysis population who had an MRSA isolated as pathogen at the baseline.|||Percentage of participants|||Number
2618990|NCT01967225|Primary|Clinical Response at Test of Cure (TOC)|Clinical response was evaluated by the masked investigator as clinical cure, clinical failure and indeterminate on the basis of the clinical symptoms/findings, vital sign and laboratory data from screening period to each evaluation point. Measurements for the assessment of clinical response included body temperature, pulse/heart rate, respiration rate, and white blood cell or band cell count.|7-14 days after the end of treatment (EOT) for skin and soft tissue infections (SSTI) and 4-6 weeks after EOT for bacteremia|This outcome measure was analyzed based on the microbiological evaluable population-methicillin-resistant Staphylococcus aureus (ME-MRSA) analysis set. The ME-MRSA consisted of clinical evaluable population at test of Cure (CE-TOC) analysis population who had an MRSA isolated as pathogen at the baseline.|||Percentage of participants|||Number
2618991|NCT01967173|Primary|The Primary Outcome is a Composite Measure That Uses Exacerbations, Asthma Control Days During the Last 12 of 14 Weeks of a Treatment Regimen, and Percent Predicted FEV1 at the End of a Treatment Regimen.|This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of exacerbations. If one treatment results in fewer exacerbations than another, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by exacerbations, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response.|The last 12 weeks of each 14-week treatment period|Not all treatments were used in all participants. Flovent 500 was not used in children and Flovent 100 was not used in adolescents and adults|||probability|||Number
2618992|NCT01967147|Secondary|Change From Baseline in IDEEL Treatment Inconvenience Score at Day 35|The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject responded to treatment inconvenience questions (Questions 6, 8-10) using a 0-4 Likert-type scale, where 0=All of the time and 4=None of the time. The IDEEL treatment inconvenience score was calculated as the sum of the responses from Questions 6, 8-10 divided by the number of questions (6, 8-10) answered, multiplied by 25, for a resultant overall score of 0-100. A positive change number represents perceived improvement.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.|||units on a scale||Standard Error|Mean
2619140|NCT01965899|Primary|Success of Wireless Transmissions|To assess the percentage of successful automatic wireless transmissions from the system within the first 30 days of implant.|30 days|All 151 subjects received a CareLink monitor software update. Subjects contributed 4,511 follow-up days in their first 30 days.|||percentage of successful transmissions|Participants|95% Confidence Interval|Number
2618993|NCT01967147|Secondary|Change From Baseline in IDEEL Treatment Effectiveness Score at Day 35|The IDEEL is a 10-item questionnaire designed to assess the subject's general satisfaction with treatment use. The subject responded to treatment effectiveness questions (Questions 2-5) using a 0-4 Likert-type scale, where 0=None of the time and 4=All of the time. The IDEEL treatment effectiveness score was calculated as the sum of the responses from Questions 2-5 divided by the number of questions (2-5) answered, multiplied by 25, for a resultant overall score of 0-100. A positive change number represents perceived improvement.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.|||units on a scale||Standard Error|Mean
2618994|NCT01967147|Secondary|Change From Baseline in OSDI Score at Day 35|The OSDI is a 12-item quality of life questionnaire designed to assess ocular surface symptoms, their severity, and their impact on the subject's ability to function. Each item was scored by the subject on a 0-4 Likert-type scale (0=None, 4=All of the Time), with a resultant overall score of 0-100 (0=no disability, 100=complete disability). A negative change number represents a perceived improvement in ocular health.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.|||units on a scale||Standard Error|Mean
2618995|NCT01967147|Secondary|Change From Baseline in TOSS Score at Day 35|The TOSS score (a cumulative cornea and conjunctival staining score) was assessed by the investigator using ophthalmic dye and a biomicroscope. Three areas of the ocular surface were graded for dryness on a 0-5 scale (0=Absent, 5=Severe), with a resultant overall score of 0-15. A negative change indicates an improvement in dry eye-related staining. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.|||units on a scale||Standard Error|Mean
2618996|NCT01967147|Primary|Change From Baseline in TFBUT at Day 35|TFBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using ophthalmic dye and a biomicroscope and measured in seconds. Subjects were dosed in the office 1 hour ±10 minutes prior to TFBUT assessment. A shorter TFBUT indicates a higher likelihood of dry eye symptoms. A positive change indicates an improvement in TFBUT. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 35|This analysis population includes all randomized subjects.|||seconds||Standard Error|Mean
2618997|NCT01967134|Secondary|Median % Change in Response to Peptides From Vaccine Antigen Ag85AB From Pre-vacc to Day 210|Responses to vaccine antigen Ag85B measure by Interferon gamma (IFN-γ) ELISpot assay Unstimulated-subtracted IFN-γ ELISpot Response (Spot forming units/10^6 PBMC) Antigen: Ag85B|Study Day 210|Subjects in all vaccinated population with available data|||percent change||95% Confidence Interval|Median
2618998|NCT01967134|Secondary|Number of Participants Who Received at Least Two Vaccinations and Tested Positive for Mtb Infection on Day 210|Measure of Mtb positivity by QuantiFERON-TB Gold In-Tube Number of Positive Responses and Shift from Screening to Study Day 210 Post-Vaccination Responses|Study Day 210|All vaccinated subjects|||Participants|||Count of Participants
2618999|NCT01967134|Secondary|Median % Change in Response to Peptides From Vaccine Antigen ESAT-6 From Pre-vaccination to Day 70 in Participants Who Received Two Vaccinations|"Percent Antigen-Specific T Cell UNS-subtracted Cytokine Response 12-Hour Whole Blood Intracellular Cytokine Staining (ICS) Assay Antigen: ESAT6 Cytokine(s): G+2+17+T+~%CD4+ T Cell Response"|Study Day 70|All vaccinated subjects|||% change from pre-vacc to day 70||95% Confidence Interval|Median
2619000|NCT01967134|Secondary|Median % Change in Response to Peptides From Vaccine Antigen Ag85B From Pre-vaccination to Day 70 in Participants Who Received Two Vaccinations|"Whole blood ICS Percent Antigen-Specific T Cell UNS-subtracted Cytokine Response Antigen: Ag85B Cytokine(s): G+2+17+T+~%CD4+ T Cell Response"|Study Day 70|All vaccinated subjects|||% change from pre-vacc to day 70||95% Confidence Interval|Median
2619001|NCT01967134|Primary|Number of Participants With at Least One Adverse Event (AE) Through Day 210|Solicited AEs: through 14 days after each vaccination Unsolicited AEs: post-vaccination on Study Days 0, 56, and 112 through 28 days after vaccination Injection site reactions and axillary lymphadenopathy: post-injection on the day of each vaccination, and Study Days 2 , 7, 14, and 28 days after each vaccination Serious adverse events (SAE): through Study Day 210|Through Study Day 210|Safety population|||Participants|||Number
2619002|NCT01967121|Primary|Pain Scores on the Visual Analog Scale|Visual Analog Scale for Muscle Soreness scale The scale for measuring the intensity of muscle soreness will be a 10 cm visual analog scale, spaced by one centimeter increments from one to 10. Ten will represent the maximum amount of soreness and zero represents no soreness at all. Subjects will be asked to complete this scale once per day at the same time of day until the soreness has dissipated. The Visual Analog Scale for muscle soreness is measured as 'scores on a scale'.|Day 1 through Day 5||||scores on a scale||Standard Deviation|Mean
2619003|NCT01967069|Primary|Percentage of Participants With Treatment Success According to the Investigator's Global Assessment (IGA)|IGA of clear or almost clear|Day 15|Intent to Treat|||percentage of subjects||95% Confidence Interval|Number
2619004|NCT01966978|Secondary|Change in Short Form-36 (SF-36) Questionnaire Score|Quality of life questionnaires will be completed by the patient at the randomization and end-of study visits. SF-36 is scored on a 1-100 scale; a higher score represents a better self-assessed health - for all domains.|Week 0 (Randomization) , Week 26||||score on a scale||95% Confidence Interval|Least Squares Mean
2619005|NCT01966978|Secondary|Change in Diabetes Quality of Life (DQOL)Questionnaire Score- Least Squares Means|Diabetes Quality of Life (DQOL) questionnaires will be completed by the patient at the randomization and end-of study visits. ALL D-QOL domains are scored on a 1-5 scale, with a lower number representing better quality of life or treatment satisfaction. Outcome reported is difference between mean baseline and mean Week 26 score.|Week 0 (Randomization) , Week 26||||score on a scale||95% Confidence Interval|Least Squares Mean
2619006|NCT01966978|Secondary|Hypoglycemic Episodes|Percentage of participants experiencing any episodes of documented hypoglycemia defined as CBG reading of <70 mg/dl|Week 0 (Randomization) , Week 2, week 4, week 13, Week 26||||percentage of participants|||Number
2619007|NCT01966978|Secondary|Mean Change From Randomization in Body Weight|Change in body weight from randomization to end of study.|Week 0 (Randomization) , Week 26||||kilogram||95% Confidence Interval|Mean
2619008|NCT01966978|Secondary|"Percentage of Participants Reaching Pre-specified Treatment Failure Outcome"|Treatment Failure defined as A1c>10% at week 13 (visit 5)|week 13||||percentage of participants|||Number
2619009|NCT01966978|Secondary|Percentage of Participants Reaching Target A1c of <7% at Week 26||Week 26||||percentage of participants|||Number
2619012|NCT01966926|Secondary|Changes in Perceptions of Weight Tracking|Perceptions of weight tracking (ease of remembering and understanding, usefulness, awareness, interest, reward value, satisfaction, motivational value) were assessed at three and six months using a scale created for the study. The scale has a range of 0 to 64, with higher scores indicating greater perceptions of favorability of weight tracking. A comparison of perceptions scores between groups and over time from 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.|three to six months||||units on a scale||Standard Deviation|Mean
2619013|NCT01966926|Secondary|Changes in Barriers to Weight Tracking|Perceived barriers to self-weighing were assessed at baseline, three, and six months using a scale created for this study. The scale has a range of 18 to 90, with higher scores indicating greater perceptions of barriers to self-weighing. A comparison of barriers scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.|baseline to 6 months||||units on a scale||Standard Deviation|Mean
2619014|NCT01966926|Secondary|Changes in Body Image|Changes in self-reported body image were assessed at baseline, three, and six months using the Appearance subscale of the Multidimensional Body Image Questionnaire. The subscale has a range of 0 to 42, with higher scores indicating better body image. A comparison of body image scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.|baseline to 6 months||||units on a scale||Standard Deviation|Mean
2619015|NCT01966926|Secondary|Changes in Anxiety|Ratings of anxiety, assessed by the Beck Anxiety Inventory, were assessed at baseline, three, and six months; a comparison of anxiety scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA. Possible scores on the scale range from 0-63. Scores from 0-7 indicate minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety.|baseline to 6 months||||units on a scale||Standard Deviation|Mean
2619016|NCT01966926|Secondary|Changes in Depression Ratings|Ratings of depressed mood, assessed by the Beck Depression Inventory, were obtained at baseline, three, and six months; the comparison of depression scores between groups and over time from baseline to 3 and 6 months was considered as a secondary outcome and analyzed using repeated measures multivariate analysis of variance (MANOVA). Scores on the inventory range from 0 to 63, with higher scores indicating greater presence of depressive symptoms. Scores from 0-10 represent normal mood; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; > 40 = extreme depression.|baseline to 6 months||||units on a scale||Standard Deviation|Mean
2619017|NCT01966926|Primary|Adherence to Weight Tracking Instructions|Participants were assigned to daily or weekly weight tracking, and were asked to return postcards once a week with weights recorded (7 for daily, 1 for weekly).|6 months|All participants were included in the analysis.|||percentage of postcards returned|||Number
2619018|NCT01966900|Primary|Number of Participants With Vaccine Related Serious Adverse Events (SAEs) Collected Throughout the Study Period||13 months||||Participants|||Count of Participants
2619019|NCT01966900|Primary|Number of Participants With Moderate or Greater and/or Vaccine-related Unsolicited Adverse Events (AEs)|Including safety laboratory (biochemical, haematological) parameters, from the day of each vaccination up to 28 days post each vaccination.|28 days||||Participants|||Count of Participants
2619020|NCT01966900|Primary|Number of Participants With Moderate or Greater Reactogenicity (i.e., Solicited Adverse Events)||7 days||||Participants|||Count of Participants
2619021|NCT01966809|Secondary|Tumor Response.|To measure complete response, partial response, stable disease or progressive disease using the response assessment for Neuro-Oncology (RANO) criteria with the follow-up medical imaging, which specifically incorporates volumetric measurements of brain tumor enhancement and clinical measures of neurological decline and to compare these outcomes to historical controls.|Six months from PDT|Participant lost to followup before secondary outcome was assessed.||||||
2619022|NCT01966809|Secondary|Progression-free Survival and Overall Survival.|To further explore and report progression-free survival and overall survival for three years post PDT treatment.|Three years from PDT|Study closed before three year period was completed. Only one participant was enrolled.||||||
2619023|NCT01966809|Secondary|Remission Rate.|To obtain preliminary data toward determining whether this combination results in higher remission rate when compared to historical data.|Three years from PDT|Study closed before three year period was completed. Only one participant was enrolled.||||||
2619024|NCT01966809|Primary|Six Month Relapse-free Survival (RFS).|Relapse free survival is the proportion of subjects who have gone six months since PDT without the disease getting worse.|Six months from PDT||||participants|||Number
2619025|NCT01966770|Primary|Overall Ease of Lens Handling (Day 2 Study Lenses)|Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 2. (0-100, 0=very difficult, 100=very easy|Day 2 - After Removal||||units on a scale||Standard Deviation|Mean
2619026|NCT01966770|Primary|Overall Ease of Lens Handling (Day 1 Study Lenses)|Participant rating of overall lens handling regarding insertion and removal. Collected at post-removal for each lens on Day 1. (0-100, 0=very difficult, 100=very easy|Day 1 - After Removal||||units on a scale||Standard Deviation|Mean
2619027|NCT01966770|Primary|Investigator Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)|Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 2 - Insertion||||percentage of investigators|||Number
2619028|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)|Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 2 - Insertion||||percentage of investigators|||Number
2619029|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)|Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 2 - Insertion||||percentage of investigators|||Number
2619030|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)|Investigator rating of fit preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 1 - 30 minutes||||percentage of investigators|Participants||Number
2619031|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)|Investigator rating of fit preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 1- 30 minutes||||percentage of investigators|Participants||Number
2619032|NCT01966770|Primary|Investigator Fit Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)|Investigator rating of fit preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of investigators that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strong R, Slight R, No Pref, Slight L, Strong L)|Day 1- 30 minutes||||percentage of investigators|Participants||Number
2619033|NCT01966770|Primary|Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 2 Study Lenses)|Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens.(Upgaze Lag and Post-blink Movement in mm)|Day 2 - 30 minutes||||millimeters|Participants|Standard Deviation|Mean
2619034|NCT01966770|Primary|Lens Fitting Characteristics, Push-up Tightness (Day 2 Study Lenses)|Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)|Day 2 - 30 minutes||||percentage|Participants|Standard Deviation|Mean
2619035|NCT01966770|Primary|Lens Fitting Characteristics, Centration (Day 2 Study Lenses)|Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)|Day 2 - 30 minutes||||percentage of lenses|Participants||Number
2619036|NCT01966770|Primary|Lens Fitting Characteristics, Upper Gaze Lag and Post-blink Movement (Day 1 - Study Lenses)|Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. (Upgaze Lag and Post-blink Movement in mm)|Day 1 - 30 minutes||||millimeter|Participants|Standard Deviation|Mean
2619037|NCT01966770|Primary|Lens Fitting Characteristics, Push-up Tightness (Day 1 Study Lenses)|Assessment of lens fitting characteristics. Collected at 30 minutes after lens settling of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)|Day 1 - 30 minutes||||percentage|Participants|Standard Deviation|Mean
2619038|NCT01966770|Primary|Lens Fitting Characteristics, Centration (Day 1 Study Lenses)|Assessment of lens fitting characteristics for the percentage of lenses with optimal centration. Collected at 30 minutes after lens settling of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)|Day 1 - 30 minutes||||percentage of lenses|Participants||Number
2619039|NCT01966770|Primary|Lens Fitting Characteristics, Upgaze Lag and Post-blink Movement (Habitual Lens)|Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens.(Upgaze Lag and Post-blink Movement in mm)|Baseline||||millimeters|Participants|Standard Deviation|Mean
2619040|NCT01966770|Primary|Lens Fitting Characteristics, Tightness (Habitual Lens)|Assessment of habitual lens fitting characteristics. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. Digital push up test. (Continuous scale 0-100%, 0%=falls from cornea without lid support, 50%=optimum, 100%=no movement)|Baseline||||percentage|Participants|Standard Deviation|Mean
2619041|NCT01966770|Primary|Lens Fitting Characteristics, Centration (Habitual Lens)|Assessment of habitual lens fitting characteristics for the percentage of lenses with optimal centration. Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (Optimal Centration for Right and Left eyes; Optimum, Decentration Acceptable, Decentration unacceptable)|Baseline||||percentage of eyes|Participants||Number
2619042|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 3)|Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right)|Day 2 - 30 minutes||||percentage of participants|||Number
2619043|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 2)|Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly prefer Left, No Preference, Slightly prefer Right, Strongly prefer Right)|Day 2 - 30 minutes||||percentage of participants|||Number
2619044|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 2 Study Lenses - Pair 1)|Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 2 - 30 minutes||||percentage of participants|||Number
2619045|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 3)|Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 2 - Insertion||||percentage of participants|||Number
2619046|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 2)|Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 2 - Insertion||||percentage of participants|||Number
2619047|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 2 Study Lenses - Pair 1)|Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 2 - Insertion||||percentage of participants|||Number
2619048|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 3)|Participant rating of comfort preference upon contact lens settling of pair 3. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - 30 minutes||||percentage of participants|||Number
2619049|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 2)|Participant rating of comfort preference upon contact lens settling of pair 2. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - 30 minutes||||percentage of participants|||Number
2619050|NCT01966770|Primary|Comfort Preference Contact Lens 30 Minutes Wear (Day 1 Study Lenses - Pair 1)|Participant rating of comfort preference upon contact lens settling of pair 1. Collected at 30 minutes post settling for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - 30 minutes||||percentage of participants|||Number
2619051|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 3)|Participant rating of comfort preference upon contact lens insertion of pair 3. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - Insertion||||percentage of participants|||Number
2619052|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 2)|Participant rating of comfort preference upon contact lens insertion of pair 2. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 Insertion||||percentage of participants|||Number
2619053|NCT01966770|Primary|Comfort Preference Contact Lens Insertion (Day 1 Study Lenses - Pair 1)|Participant rating of comfort preference upon contact lens insertion of pair 1. Collected at insertion for each lens. Percent of participants that strongly prefer lens or have No Preference. (forced choice preference for right or left eye; Strongly Prefer Left, Slightly Prefer Left, No Preference, Slightly Prefer Right, Strongly Prefer Right)|Day 1 - Insertion||||percentage of participants|||Number
2619054|NCT01966770|Primary|Comfort Contact Lens 30 Minutes Wear (Day 2 Study Lenses)|Participant rating of comfort upon contact lens insertion. Collected after 30 minutes of wear at Day 2 for each lens . (0-100, 0=cannot be be worn causes pain, 100=cannot be felt ever|Day 2 - 30 minutes||||units on a scale||Standard Deviation|Mean
2619055|NCT01966770|Primary|Comfort Contact Lens Insertion (Day 2 Study Lenses)|Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 2 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever|Day 2 - Insertion||||units on a scale||Standard Deviation|Mean
2619056|NCT01966770|Primary|Comfort Contact Lens 30 Minutes Wear (Day 1 Study Lenses)|Participant rating of comfort after contact lens settling. Collected at 30 minutes wear for each lens. (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever)|Day 1 - 30 minutes||||units on a scale||Standard Deviation|Mean
2619057|NCT01966770|Primary|Comfort Contact Lens Insertion (Day 1 Study Lenses)|Participant rating of comfort upon contact lens insertion. Collected after insertion at Day 1 for each lens . (0-100, 0=cannot be worn causes pain, 100=cannot be felt ever)|Day 1 - Insertion||||units on a scale||Standard Deviation|Mean
2619058|NCT01966770|Primary|Visual Acuity (VA) logMAR (Study Lenses)|Assessment of high contrast distance visual acuity (VA). Collected at dispense of study lens. (logMAR)|Dispense||||LogMAR||Standard Deviation|Mean
2619059|NCT01966770|Primary|Visual Acuity (VA) logMAR (Habitual Lenses)|Assessment of high contrast distance visual acuity (VA). Collected at baseline with subject wearing habitual lens prior to dispense of study lens. (logMAR)|Baseline||||LogMar||Standard Deviation|Mean
2619060|NCT01966718|Secondary|Change From Baseline in the C-Reactive Protein (CRP) Level|CRP was measured at Baseline and Week 16. Change was calculated by subtracting week 16 value from baseline value, with a positive value indicating a decrease from baseline.|From baseline to week 16||||mg/dL||Full Range|Mean
2619061|NCT01966718|Secondary|Change From Baseline in the Erythrocyte Sedimentation Rate (ESR)|ESR was measured at baseline at week 16. Change was measured by subtracting week 16 score from baseline score. A positive number indicates that the ESR decreased|From baseline to week 16||||mm/hr||Full Range|Mean
2619062|NCT01966718|Primary|Change From Baseline in the 20-item Health Assessment Questionnaire Score|"Subjects completed the Health Assessment Questionnaire, a 20-item scale that measures health-related quality of life. Participants are asked to rate activities on a scale from able to do with no difficulties to unable to do. A score of 0 indicates the participant has no problems performing daily activities, while a score of 3 indicates that the participant is completely disabled. Scores were calculated by subtracting score at week 16 from baseline score. A positive number indicates the score went down from baseline to week 16."|From baseline to week 16||||units on a scale||Full Range|Mean
2619063|NCT01966718|Primary|Change From Baseline in the Ritchey-Camp Articular Index|Change in the Number of Joints that had Tenderness and/or Swelling According to the Ritchey-Camp Articular Index. Change was calculated using baseline and week 16 time points.|From baseline to week 16||||joints|Participants|Full Range|Mean
2619224|NCT01965288|Secondary|Lower Palpebral Hyperaemia|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
2619064|NCT01966458|Secondary|Number of Participants With Stroke-Free Success|Success is defined as alive on the originally implanted device, electively transplanted or explanted due to subject recovery and free from disabling stroke (Modified Rankin Scale >=4).|Implant to 12 Months|Subjects were excluded if they had no associated 24 week post-stroke Modified Rankin Scale value, or if the subject withdrew or was lost to follow-up on original device, and no other failure outcome occurred within 1 year post original implant.|||Participants|||Count of Participants
2619065|NCT01966458|Secondary|Number of HeartWare VAS Participants With Stroke/TIA|The first secondary endpoint is the number of HeartWare VAS participants with stroke/TIA at 12 months on the originally implanted device.|Implant to 12 Months|Subjects were excluded if they withdrew or were lost to follow up on the original device.|||Participants|||Count of Participants
2619066|NCT01966458|Primary|Number of Participants With Neurologic Injury|The primary endpoint is the percent of participants at 12 months on the originally implanted device with neurologic injury, defined as a stroke with Modified Rankin Scale (MRS) > 0 at 24-weeks post-stroke, or a transient ischemic attack (TIA), or a spinal cord infarction (SCI). The Modified Rankin Scale is scored from 0 to 6, where 0 indicates an absence of symptoms and 6 indicates death. A score of 4 or higher indicates moderately severe or greater disability.|Implant to 12 Months|Subjects were excluded if they withdrew, were lost to follow-up or have missing outcomes on original device.|||Participants|||Count of Participants
2619067|NCT01966445|Secondary|Percentage of Cluster of Differentiation (CD) Marker|Blood samples were collected on Day (D) 1 at pre-dose (pre) and at 1 hour (h) and 6 h post infusion for the analysis of markers to evaluate biological activity of GSK2849330. A pre-dose blood sample was collected on D8, D15 and D29 with additional blood sample collected at progression of disease. CDX241 represent CD45+CD3-CD56+CD16+CD69+CD107+, CDX243=CD45+CD3-CD56+CD16+CD69+CD107-; CDX244=CD45+CD3-CD56+CD16+CD69-CD107+ and CDX245=CD45+CD3-CD56+CD16+CD69-CD107-. For participants in GSK2849330 3 mg/kg weekly arm, two samples (S1 and S2) were collected for D15 analysis. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.|Median of 6.143 weeks of drug exposure|PD Population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles)|||Percentage of CD marker cells||Standard Deviation|Mean
2619068|NCT01966445|Secondary|Number of Participants With Antibodies to GSK2849330 in Serum|Serum samples were collected for the determination of anti-GSK2849330 antibodies using a validated immunoelectrochemiluminescent (ECL) assay. The assay involved screening, confirmation and titration steps (tiered-testing approach). If serum samples contained anti-GSK2849330 antibodies, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive samples were titrated to obtain the titers of antibodies. The number of participants who tested positive for anti-GSK2849330 antibody in confirmatory testing on Day 1 and at any time post-Baseline is presented. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.|Median of 6.143 weeks of drug exposure|All Treated Population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles)|||Participants|||Count of Participants
2619069|NCT01966445|Secondary|Overall Response Rate (ORR)-Parts 1 and 2|ORR was determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST v 1.1). ORR was calculated as the number of participants with best overall response of complete response (CR) and partial response (PR). CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter (mm) in the short axis and PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters (e.g., percent change from Baseline). An estimate to the true response rate for the number of participants analyzed is given. The 95% confidence interval was the exact confidence interval based on binomial proportion for ORR. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.|Median of 6.143 weeks of drug exposure|All Treated Population|||Participants||95% Confidence Interval|Number
2619070|NCT01966445|Secondary|Serum HER3 From Tumor Tissue-Parts 1 and 2|Pre-treatment and on-treatment biopsy tissues (tumor and normal skin) were analyzed for markers of HER3 pathway such as HER3 that may indicate a pharmacodynamic (PD) response to GSK2849330. Serum HER3 (soluble HER3) analyses was performed. The analysis was performed on PD population which comprised of all participants who received at least one dose of GSK2849330 and for whom at least one evaluable paired pre-treatment PD sample and on-treatment PD sample were obtained and analyzed. Mean and standard deviation for serum HER3 is presented. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.|Day 1 (pre-dose, 1 hour, 6 hours), Day 2, Day 8, Day 15, Day 29 and follow-up (28 days post last dose)|PD Population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).|||Nanomoles||Standard Deviation|Mean
2619071|NCT01966445|Secondary|AUC(0 to 168) and AUC(0 to 336) for GSK2849330-Part 2|PK parameters for Part 2 were not analyzed due to sparse sampling. The protocol was written in a flexible way to either pursue or not pursue additional analyses in Part 2.|Day 1 (pre-dose, 1 and 6 hours post-dose), Day 8, Day 15, Day 29, and every 12 weeks from first dose|PK Parameter Population. PK parameters for Part 2 were not analyzed due to sparse sampling.||||||
2619072|NCT01966445|Secondary|Area Under the Concentration Time Curve (AUC) to a Fixed Nominal Time (AUC[0 to 168]) and AUC(0 to 336) for GSK2849330-Part 1|The AUC to a fixed nominal time AUC(0-168) and AUC(0-336) were calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at indicated time points for determination of PK parameters.|Day 1 (pre-dose, 1 and 6 hours post-dose), Day 8, Day 15, Day 29, and every 12 weeks from first dose|PK Parameter Population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2619073|NCT01966445|Secondary|Tmax for GSK2849330-Part 2|PK parameters for Part 2 were not analyzed due to sparse sampling. The protocol was written in a flexible way to either pursue or not pursue additional analyses in Part 2.|Day 1 (pre-dose, 1 and 6 hours post-dose), Day 8, Day 15, Day 29, and every 12 weeks from first dose|PK Parameter Population. PK parameters for Part 2 were not analyzed due to sparse sampling.||||||
2620552|NCT01954160|Secondary|Left Ventricular End Systolic Volume|Echo: Left ventricular end systolic volume Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2619074|NCT01966445|Secondary|Time of Occurrence of Cmax (Tmax) for GSK2849330-Part 1|The time at which Cmax is observed was determined directly from the raw concentration-time data is defined as Tmax. Blood samples were collected at indicated time points for evaluation of pharmacokinetic parameters.|Day 1 (pre-dose, 1 and 6 hours post-dose), Day 8, Day 15, Day 29, and every 12 weeks from first dose|PK Parameter Population|||Hours||Full Range|Median
2619075|NCT01966445|Secondary|Cmax of GSK2849330-Part 2|PK parameters for Part 2 were not analyzed due to sparse sampling. The protocol was written in a flexible way to either pursue or not pursue additional analyses in Part 2.|Day 1 (pre-dose, 1 and 6 hours post-dose), Day 8, Day 15, Day 29, and every 12 weeks from first dose|PK Parameter Population. PK parameters for Part 2 were not analyzed due to sparse sampling.||||||
2619076|NCT01966445|Secondary|Maximum Observed Plasma Concentration (Cmax) of GSK2849330-Part 1|The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data is defined as Cmax. Blood samples were collected at indicated time points. The analysis was performed on pharmacokinetic (PK) parameter population which comprised of all participants from the PK concentration population (participants who received at least one dose of GSK2849330 and for whom at least one post-dose PK sample was obtained and analyzed) for whom valid and valuable PK parameters were derived.|Day 1 (pre-dose, 1 and 6 hours post-dose), Day 8, Day 15, Day 29, and every 12 weeks from first dose|PK Parameter Population|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2619077|NCT01966445|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings-Parts 1 and 2|A 12-lead ECG was measured using an automated ECG machine after at least 5 minutes of rest for the participant in a semi-recumbent or supine position. Number of participants with abnormal ECG findings at any time post-Baseline is presented. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.|Median of 6.143 weeks of drug exposure|All Treated Population|||Participants|||Count of Participants
2619078|NCT01966445|Primary|Number of Participants With Change From Baseline in Vital Signs-Parts 1 and 2|Vital sign measurements included systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature (Temp) and heart rate (HR). Vital signs were graded according to NCI-CTCAE version 4.0. The following criteria was used to flag vital signs of potential clinical importance: change from Baseline in HR (decrease to <60 beats per minute and increase to >100 beats per minute); increase in SBP from Baseline (>=120 to <140 millimeters of mercury [mmHg] Grade 1; >=140 to <160 mmHg [Grade 2]; >=160 [Grade 3]); increase in DBP from Baseline (>=80 to <90 [Grade 1]; >=90 to <100 [Grade 2]; >=100 mmHg [Grade 3]) and change in temperature from Baseline (increase to >=38 or decrease to <=35 degree Centigrade). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as visit value minus Baseline value. The data for worst-case post Baseline is presented.|Baseline and median of 6.143 weeks of drug exposure|All Treated Population|||Participants|||Count of Participants
2619079|NCT01966445|Primary|Number of Participants With Change From Baseline in Urinalysis Data With Respect to Normal Range-Parts 1 and 2|Urine samples were collected for the analysis of urine potential of hydrogen (pH) and urine specific gravity. A laboratory value that was outside the reference range was considered either high abnormal (value above the upper limit of the reference range) or low abnormal (value below the lower limit of the reference range). Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Change from Baseline was calculated as visit value minus Baseline value. The data for worst-case post Baseline is presented. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.|Baseline and median of 6.143 weeks of drug exposure|All Treated Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2619080|NCT01966445|Primary|Number of Participants With Change From Baseline in Hematology Data With Respect to Normal Range-Parts 1 and 2|Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, hematocrit, mean corpuscle hemoglobin concentration (MCHC), mean corpuscle hemoglobin (MCH), mean corpuscle volume (MCV), monocytes, red blood cell count (RBC) and reticulocytes. A laboratory value that was outside the reference range was considered either high abnormal (value above the upper limit of the reference range) or low abnormal (value below the lower limit of the reference range). Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Change from Baseline was calculated as value at visit minus Baseline value. Number of participants with change from Baseline in hematology data at worst-case post Baseline is presented. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.|Baseline and median of 6.143 weeks of drug exposure|All Treated Population|||Participants|||Count of Participants
2619081|NCT01966445|Primary|Number of Participants With Grade Change From Baseline in Hematology Data-Parts 1 and 2|Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, total neutrophils, platelet count, and white blood cell (WBC). The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Change from Baseline was calculated as visit value minus Baseline value. Number of participants with any grade increase, increase to Grade 3 and increase to Grade 4 in hematology data at worst-case post Baseline is presented. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.|Baseline and median of 6.143 weeks of drug exposure|All Treated Population|||Participants|||Count of Participants
2619092|NCT01966354|Secondary|Infectious Complications|The incidence of bacterial catheter colonization and catheter-related blood stream infection will be registered once the central venous catheter has been withdrawn. Patients will be followed for the duration of central venous access, an expected average of 8 weeks. The number of patients with bacterial colonization and catheter-related blood stream infection will be registered.|Once the central venous catheter is withdrawn (2 months)||||participants|||Number
2619225|NCT01965288|Secondary|Lower Palpebral Hyperaemia|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
2619082|NCT01966445|Primary|Number of Participants With Change From Baseline in Clinical Chemistry Data With Respect to Normal Range-Parts 1 and 2|Blood samples were collected for the analysis of following clinical chemistry parameters: direct bilirubin (D.Bil.), cancer antigen (CA)-125, CA-15.3, CA19-9, chloride, carbon dioxide (CO2)/bicarbonate (HCO3), luteinizing hormone (LH), total protein and urea or blood urea nitrogen (BUN). Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Change from Baseline was calculated as visit value minus Baseline value. A laboratory value that is outside the reference range was considered either high abnormal (value above the upper limit of the reference range) or low abnormal (value below the lower limit of the reference range). Number of participants with change from Baseline in clinical chemistry data at worst-case post Baseline is presented. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.|Baseline and median of 6.143 weeks of drug exposure|All Treated Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2619083|NCT01966445|Primary|Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Parts 1 and 2|Blood samples were collected for the analysis of following clinical chemistry parameters: albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (Total bil), calcium, creatinine, gamma glutamyl transferase (GGT), glucose, potassium, magnesium, sodium, phosphorus, uric acid. Laboratory parameters were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Change from Baseline was calculated as visit value minus Baseline value. Data for worst-case post Baseline is presented. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.|Baseline and median of 6.143 weeks of drug exposure|All Treated Population. Only those participants with data available at specified time points were analyzed (represented by n=X in category titles).|||Participants|||Count of Participants
2619084|NCT01966445|Primary|Number of Participants With Dose-limiting Toxicities (DLTs)-Parts 1 and 2|An event was considered a DLT if it occured within the first 4 weeks (28 days) of treatment, and met one of the following criteria unless it could be established that the event was unrelated to treatment: Grade 3 or greater non-hematologic toxicity; Grade 4 neutropenia lasting >5 days; Febrile neutropenia, of any grade or duration; Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia associated with bleeding; Alanine aminotransferase (ALT) >3 times upper limit of normal (ULN) with bilirubin >2 times ULN; Any Grade 2 or greater toxicity that in the judgment of the investigator and GlaxoSmithKline (GSK) Medical Monitor, would be considered dose-limiting; Grade 3 or greater decrease in LVEF. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.|Up to 28 days|All Treated Population|||Participants|||Count of Participants
2619085|NCT01966445|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Parts 1 and 2|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; and left ventricular ejection fraction (LVEF) meeting stopping criteria. AEs were collected in All Treated Population which comprised of all participants who received at least one dose of GSK2849330. Treatment groups with same dose and administration frequency were combined as pre-specified in reporting and analysis plan.|Median of 6.143 weeks of drug exposure|All Treated Population|||Participants|||Count of Participants
2619086|NCT01966432|Primary|Treatment for Drug Use or Alcohol|Percentage of patients who received substance abuse or alcohol treatment (self reported)|Baseline, Six Month Follow-up|All subjects who completed the assessments were included.|||percentage of participants||95% Confidence Interval|Number
2619087|NCT01966432|Primary|Percentage of Participants Who Reported Substance Use at 6 Month|For SBI and SBIRT groups: Proportion of baseline substance users (SBI, SBIRT) who continue substance use during the study (self reported) For S group: Proportion of baseline non-users (S) who report substance use during follow-up visit|Baseline, Six Month Follow-up|All subjects who completed the assessments were included.|||percentage of participants||95% Confidence Interval|Number
2619088|NCT01966432|Primary|Alcohol Use Status|Results of AUDIT-C survey. The AUDIT-C is a 3-item alcohol screen that can help identify people who are hazardous drinkers or have active alcohol use disorders. AUDIT-C is scored on a scale of 0-12. The higher the score, the more likely it is that the person's drinking is affecting his/her safety|Baseline, Six Month Follow-up|All subjects who completed the assessments were included.|||units on a scale||95% Confidence Interval|Mean
2619089|NCT01966432|Primary|Cigarette Smoking Status and Nicotine Dependence|Results from Fagerstrom Test for Nicotine Dependence. The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.|Baseline, Six Month Follow-up|All subjects who completed the assessments were included.|||units on a scale||95% Confidence Interval|Mean
2619090|NCT01966432|Primary|Drug Use Status and Frequency|Results of DAST-10 survey to determine use of illicit or nonmedical drugs.The Drug Abuse Screening Test (DAST-10) is a 10-item brief screening tool that assesses drug use, not including alcohol or tobacco use, in the past 12 months. Each question requires a yes or no response, and the tool can be completed in less than 8 minutes. DAST-10 scores on a 10-point scale. A score of 0 indicates no problems and 10 indicates a severe level of problems are associated with drug abuse.|Baseline, Six Month Follow-up|All subjects who completed the assessments were included.|||units on a scale||95% Confidence Interval|Mean
2619093|NCT01966354|Secondary|Mechanical Complications|The incidence of the following mechanical complications will be registered: number of patients with accidental arterial puncture, number of patients with puncture site bleeding, number of patients with puncture site haematoma, number of patients with pneumothorax, number of patients catheter tip misplacement. This outcome measure will be registered at the end of the cannulation process, and once a control chest x-Ray has been performed.|At the end of the cannulation process (180 seconds, maximum)||||participants|||Number
2619094|NCT01966354|Secondary|Cannulation Time|Time elapsed (seconds) from the moment the Seldinger needle pierces the skin to the moment the guidewire is inserted inside the vein. This outcome measure will be registered at the end of the cannulation process.|At the end of the cannulation process (180 seconds, maximum)||||seconds||Standard Deviation|Mean
2619095|NCT01966354|Secondary|First Attempt Cannulation|"Any cannulation that has been accomplished with a single cannulation attempt will be considered a first attempt cannulation. This outcome measure will be registered at the end of the cannulation process."|At the end of the cannulation process (180 seconds, maximum)||||participants|||Number
2619096|NCT01966354|Secondary|Number of Cannulation Attempts|Number of cannulation attempts that have taken place before cannulation success. Any withdrawal of the needle followed by an advance will be considered a separated cannulation attempt.This outcome measure will be registered at the end of the cannulation process.|At the end of the cannulation process (180 seconds, maximum)||||attempts||Standard Deviation|Mean
2619097|NCT01966354|Primary|Cannulation Success|"Cannulation will be considered as successful once a flexible guidewire has been inserted into the internal jugular vein during the first 180 seconds from the moment the Seldinger needle pierces the skin. If time spent until guidewire insertion is more than 180 seconds, or if guidewire cannot be inserted into the internal jugular vein chosen, cannulation will be considered unsuccessful. This outcome measure will be registered at the end of the cannulation process."|At the end of the cannulation process (180 seconds, maximum)||||participants|||Number
2619098|NCT01966159|Other Pre-specified|Target Lesion Failure (TLF) Rate|Target lesion failure is any ischemia-driven revascularization of the target lesion, MI (Q-wave and non-Q-wave) related to the target vessel, or (cardiac) death.|12 months post-index procedure||||percentage of participants|||Number
2619099|NCT01966159|Secondary|Target Lesion Revascularization (TLR) Rate|Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 months post-index procedure||||percentage of participants|||Number
2619100|NCT01966159|Primary|The In-stent Late Loss Measured by Quantitative Coronary Angiography||at 9 months post-index procedure.||||mm||Standard Deviation|Mean
2619101|NCT01966120|Primary|Overall Patient Complete Response 12 Weeks After the Last PDT (PP)|"All efficacy variables were evaluated for the FAS. The primary efficacy variable was also analyzed for the PP population. All subgroup analyses were carried out for the FAS. Data for size and grade of AK lesions were analyzed using the last observation carried forward (LOCF) approach, affecting the response rates evaluation.~Due to the small amount of missing data in the study, which did not have any relevant impact on primary results, sensitivity analyses for missing data were not performed.~The primary efficacy variable was the overall patient complete response 12 weeks after the last PDT. An overall complete responder was defined as a patient in whom all treated AK lesions were cleared (Olsen score of 0) after the last PDT, i.e. after PDT 1 or after PDT 2 if re-treatment was performed."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Per Protocol Set (PP)|||percentage of participants||95% Confidence Interval|Number
2619102|NCT01966120|Secondary|Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 1 to 3|"Study personnel assessed and recorded the skin quality of the treated field(s) at baseline and at the end-of-study visit including skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring and atrophy.~Upon visual examination of the treated field(s), the investigator coded the intensity of each skin parameter on a scale of 0 to 3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.~The cosmetic outcome evaluations were based on the sum score of the skin quality assessment (sum of all ratings for each skin parameter) at the end-of-study visit (Visit 4 or Visit 6, if retreated).~The outcome was calculated using a 5-point scale ranging from very good (0) to impaired (4) based on the change of the skin quality assessments compared to baseline (0 = 2 points improvement; 1 = 1 point improvement; 2 = no change; 3 = 1 point worsened; 4 = at least 2 points worsened)."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)|||percentage of participants||95% Confidence Interval|Number
2619103|NCT01966120|Secondary|Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 0 to 3|"Study personnel assessed and recorded the skin quality of the treated field(s) at baseline and at the end-of-study visit including skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring and atrophy.~Upon visual examination of the treated field(s), the investigator coded the intensity of each skin parameter on a scale of 0 to 3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.~The cosmetic outcome evaluations were based on the sum score of the skin quality assessment (sum of all ratings for each skin parameter) at the end-of-study visit (Visit 4 or Visit 6, if retreated).~The outcome was calculated using a 5-point scale ranging from very good (0) to impaired (4) based on the change of the skin quality assessments compared to baseline (0 = 2 points improvement; 1 = 1 point improvement; 2 = no change; 3 = 1 point worsened; 4 = at least 2 points worsened)."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)|||percentage of participants||95% Confidence Interval|Number
2619104|NCT01966120|Secondary|Change of Total Lesion Area 12 Weeks After Last PDT|The fifth key secondary efficacy variable in the hierarchic test procedure was the change from baseline in the total lesion area per patient assessed at 12 weeks after last PDT.|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)|||percentage of lesion area change||Standard Deviation|Mean
2620704|NCT01953224|Other Pre-specified|Number of Participants With Adverse Events|We will inquire about potential adverse events during counseling calls and assessment visits. Discrete events will be summed, and the number of participants with events will be summed.|12 weeks|||||||
2619105|NCT01966120|Secondary|Patient Partial Response 12 Weeks After Last PDT|The fourth key secondary efficacy variable in the hierarchic test procedure was the patient partial response (defined as complete clearance of at least 75% of treated AK lesions) assessed at 12 weeks after last PDT.|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)|||percentage of participants||95% Confidence Interval|Number
2619106|NCT01966120|Secondary|Lesion Complete Response 12 Weeks After Last PDT|The third key secondary efficacy variable in the hierarchic test procedure was the lesion complete response (completely cleared individual AK lesions) assessed at 12 weeks after last PDT.|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)|||percentage of lesions|Number of Lesions Analyzed|95% Confidence Interval|Number
2619107|NCT01966120|Secondary|Patient Complete Response 12 Weeks After PDT 1|The second key secondary efficacy variable in the hierarchic test procedure was the patient complete response (complete clearance of all treated AK lesions) assessed at 12 weeks after PDT 1.|12 weeks after PDT 1|Full Analysis Set (FAS)|||percentage of participants||95% Confidence Interval|Number
2619108|NCT01966120|Secondary|Patient Histopathological Confirmed Response Rate|"For the secondary confirmatory analysis, several superiority hypotheses were tested within a pre-defined hierarchic multiple testing procedure as described in the Statistical Analysis Protocoll (SAP).~The key secondary efficacy variables were tested strictly in a pre-defined order to ensure the family-wise error rate (FWER) and the testing procedure had to be stopped once the first non-significant test was obtained.~The results of the confirmatory analysis are presented in the order pre-defined by the confirmatory testing procedure.~Assessments of the patient histopathological confirmed response (HCR) rates were based on the results from the biopsy taken 12 weeks after the last PDT from a representative AK lesion selected at screening. If the biopsy result for a patient revealed a residual AK, the patient was considered not cleared for the analysis irrespectively of the investigator's clinical assessment."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS) 6 patients (1 BF-200 ALA and 5 Placebo patients) had a missing evaluation of the second biopsy 12 weeks after PDT.|||percentage of participants||95% Confidence Interval|Number
2619109|NCT01966120|Primary|Overall Patient Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT)|"All efficacy variables were evaluated for the FAS. The primary efficacy variable was also analyzed for the PP population. All subgroup analyses were carried out for the FAS. Data for size and grade of AK lesions were analyzed using the last observation carried forward (LOCF) approach, affecting the response rates evaluation.~Due to the small amount of missing data in the study, which did not have any relevant impact on primary results, sensitivity analyses for missing data were not performed.~The primary efficacy variable was the overall patient complete response 12 weeks after the last PDT. An overall complete responder was defined as a patient in whom all treated actinic keratosis (AK) lesions were cleared (Olsen score of 0) after the last PDT, i.e. after PDT 1 or after PDT 2 if re-treatment was performed."|12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT|Full Analysis Set (FAS)|||percentage of participants||95% Confidence Interval|Number
2619110|NCT01966107|Primary|Number of Participants With Major Adverse Cardiovascular Event (MACE) - on Study Analysis|To assess the cardiovascular (CV) safety of aclidinium bromide on MACEs. The number of subjects with an adjudicated composite MACE with treatment group, baseline CV severity, and smoking status as factors. MACE for the analyses was defined as any adjudicated event which was a composite of the total of CV death, non-fatal myocardial infarction (MI), or non-fatal stroke (on-study analysis).|At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU)|The Full Analysis Set (FAS) population consisted of all subjects in the Randomized Population who took at least one dose of the double-blind IP (aclidinium bromide or placebo). Subjects were analyzed according to their randomized treatment.|||Participants|||Count of Participants
2619111|NCT01966107|Secondary|Number of Participants With Major Adverse Cardiovascular Event (MACE) or Other Serious Cardiovascular Events of Interest - On-study Analysis|"To assess the CV safety of aclidinium bromide on MACEs. The number of subjects with an adjudicated MACE or other serious CV events of interest with treatment group, baseline CV severity, and smoking status as factors.~Other serious CV events included events from Cardiac tachyarrhythmias plus preferred terms (PTs) Tachycardia, Heart rate increase, and Palpitation; Cardiac failure; Bradycardia and PTs Sinus arrest and Sinus bradycardia; Conduction defects; Conditions associated with Central nervous system haemorrhages and cerebrovascular accidents; and selected PTs included in the Other ischemic heart disease."|At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU)|The Full Analysis Set (FAS) population consisted of all subjects in the Randomized Population who took at least one dose of the double-blind IP (aclidinium bromide or placebo). Subjects were analyzed according to their randomized treatment.|||Participants|||Count of Participants
2619112|NCT01966107|Secondary|Rate of Hospitalizations Due to COPD Exacerbation Per Subject Per Year During the First Year of Treatment- on Treatment Analysis|To assess whether aclidinium bromide reduces moderate or severe COPD exacerbations. The rate of hospitalization (number of events per subject per year) due to COPD exacerbations during the first year of treatment based on on-treatment analysis with treatment group, baseline ICS use, baseline COPD severity, history of at least 1 exacerbation in the past year, and smoking status as factors and the log of the exposure time adjusted for the time the subjects experienced exacerbations as an offset variable.|12 months|The Full Analysis Set (FAS) population consisted of all subjects in the Randomized Population who took at least one dose of the double-blind IP (aclidinium bromide or placebo). Subjects were analyzed according to their randomized treatment.|||Events per subject per year||95% Confidence Interval|Number
2619138|NCT01965899|Primary|R-wave Amplitudes Greater Than or Equal to 200 μV|The proportion of R-wave amplitudes that are greater than or equal to 200 μV will be estimated at implant and one month.|30 days|For each subject implanted with a Reveal LINQ device an R-wave amplitude measurement is collected at implant and 1 month follow-up.|||Percentage of subjects|||Number
2619139|NCT01965899|Primary|R-wave Amplitude|To characterize the signal quality of the R-wave amplitude at implant and one month.|30 days|For each subject implanted with a Reveal LINQ device an R-wave amplitude measurement is collected at implant and 1 month follow-up.|||μV||Standard Deviation|Mean
2619113|NCT01966107|Primary|Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Subject Per Year During the First Year of Treatment|The rate (number of events per subject per year) of moderate or severe COPD exacerbations during the first year of treatment based on on-treatment analysis with treatment group, baseline inhaled corticosteroids (ICS) use, baseline COPD severity, history of at least 1 exacerbation in the past year, and smoking status as factors and the log of the exposure time adjusted for the time the subjects experienced exacerbations as an offset variable.|12 months|The Full Analysis Set (FAS) population consisted of all subjects in the Randomized Population who took at least one dose of the double-blind IP (aclidinium bromide or placebo). Subjects were analyzed according to their randomized treatment.|||Events per subject per year||95% Confidence Interval|Number
2619114|NCT01966068|Primary|Difference Between Number of Families Who Adopted MyAsthma Portal Use and Number of Families With Sustained Use|Implementation success was measure by comparing the of the number of enrolled families (parent/guardian) who logged on to the MyAsthma Portal once (adoption) with the number of enrolled families (parent/guardian) who logged on more than once (sustained use). Parents/guardians were asked to log on and complete the same survey on the MyAsthma Portal 3 times during a 6 month period.|Up to 6 Months|Analysis population included every subject (parent/guardian) who logged on to the MyAsthma Web Portal at least once.|||participants|||Number
2619115|NCT01966042|Secondary|Functional Change Evaluation|Analysis of objective improvement in myocardial ischemia (in %), by stress technetium scintigraphy.|Baseline, 6 and 12 months||||percentage of area change||Standard Deviation|Median
2619116|NCT01966042|Other Pre-specified|Life Quality|"Analysis of the variation in life quality questionnaire - Short Form Health Survey (SF-36) was performed. Each domain of the questionnaire was evaluated as a quantitative variable and the medians were retrieved before and after the procedure.~The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.~It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.~One patient was lost before answering the questionnaire post procedure."|Baseline and 12 months||||units on a scale||Standard Deviation|Median
2619117|NCT01966042|Secondary|Functional Change Evaluation|Analysis of Left Ventricular Ejection Fraction (in %), by echocardiogram.|Baseline and 12 months||||percentage of Left Ventrical Ejection||Standard Deviation|Median
2619118|NCT01966042|Primary|Angina Class Variation|"It was evaluated in accordance with the percentage of participants that change the functional class of angina according to CCSAC (Canadian Cardiovascular Society Angina Classification - description below), after treatment. The functional class of angina was also analyzed as an ordinal variable and the median of the functional class was calculated before and after the procedure, at the time of interest (3, 6 and 12 months post treatment), in comparison to baseline, ie. value at 3 months minus value at baseline.~Screening of Functional Graduation of Stable Angina:~I - Angina only occurs after a fast or prolonged and strenuous effort during work or recreation.~II - Slight limitation to everyday activities. III - Considerable limitation of common physical activity. IV - Inability to perform any physical activity without discomfort, the symptoms can be present at rest."|3, 6 and 12 months||||Angina Classification||Standard Deviation|Median
2619119|NCT01966003|Secondary|Overall Survival|"Overall survival (OS) was defined as the time from the randomization date to date of death. Participants alive at the end of study were censored at the last date known to be alive, derived from dates collected within the study that implied a participant was alive.~Participants were followed for survival status during the treatment phase and thereafter every 9 weeks until the end of the clinical study, consent was withdrawn, they were lost to follow-up, died, or had proscribed therapy (eg, commercial bevacizumab, non-study anti-cancer treatment)."|From randomization until the end of study; The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.|Safety analysis population|||months||95% Confidence Interval|Median
2619120|NCT01966003|Secondary|Number of Participants Who Developed Anti-drug Antibodies|Two validated assays were used to detect the presence of anti-ABP 215 antibodies. Samples were first tested in an electrochemiluminescence (ECL)- based bridging immunoassay to detect antibodies capable of binding to ABP 215 (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based target binding assay to determine neutralizing activity against ABP 215 (Neutralizing Antibody Assay). If a post-dose sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.|44 weeks (6 months after end of treatment)|Safety analysis population with available data|||participants|||Number
2619121|NCT01966003|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4, and according to the following scale: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death due to AE.~A serious adverse event (SAE) is defined as an AE that meets at least 1 of the following serious criteria:~fatal~life-threatening~required inpatient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event"|up to 19 weeks|Safety analysis population consisted of all participants who received any amount of study drug.|||participants|||Number
2619122|NCT01966003|Secondary|Progression-free Survival|"Progression-free survival (PFS) was defined as the time from the randomization date to the date of disease progression using RECIST v1.1 based on the central, independent, blinded radiologists' review, or death. Participants who were alive and did not meet the criteria for progression by the end of the study were censored at their last evaluable disease assessment date. Participants with no evaluable tumor assessments after randomization who did not die by the end of the study were censored on the randomization date.~Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm, or, unequivocal progression of existing non-target lesions, or any new lesions."|From randomization until the end of study; The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.|Intent-to-treat population|||months||95% Confidence Interval|Median
2619123|NCT01966003|Secondary|Duration of Response|"Duration of response (DOR) was calculated as the time from the first objective response (PR or CR) to disease progression per RECIST v1.1 based on the central, independent, blinded radiologists' review.~DOR was only calculated for participants with an objective response. For responders not meeting the criterion for progression by the end of the study, DOR was censored at the date of the last evaluable tumor assessment.~Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm, or, unequivocal progression of existing non-target lesions, or any new lesions."|Disease assessments were performed at weeks 1, 7, 13, 19, and approximately every 9 weeks thereafter. The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.|Intent-to-treat population with an objective response|||months||95% Confidence Interval|Median
2619124|NCT01966003|Primary|Percentage of Participants With an Objective Response|"Tumor assessments were performed by central, independent, blinded radiologists according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest and abdomen. Objective response is defined as a best overall response of partial response (PR) or complete response (CR) as defined by RECIST v1.1. All participants who did not meet the criteria for CR or PR by the end of the study were considered non-responders.~CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must be reduced in short axis to < 10 mm.~PR: Disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions, or, at least a 30% decrease in the sum of diameters of target lesions, with no progression of existing non-target lesions and no new lesions."|Disease assessments were performed at weeks 1, 7, 13, 19, and approximately every 9 weeks thereafter. The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.|Intent-to-treat population which consisted of all randomized participants.|||percentage of participants|||Number
2619125|NCT01965938|Secondary|Alternate Device Used||<100 seconds||||number times an alternate device used|||Number
2619126|NCT01965938|Other Pre-specified|Oropharyngeal Injuries|Number of patients with any notation of any trauma to lips, teeth, soft tissue, etc.|24 hours||||participants|||Number
2619127|NCT01965938|Secondary|Lowest Pulse Oximetry Saturation Value Reading During Intubation|Lowest pulse oximetry saturation value reading collected from any participant during intubation|<100 seconds||||percentage of saturated hemoglobin|||Number
2619128|NCT01965938|Secondary|Assistance Maneuvers, if Any, Provided by the Attending Anesthesiologist|Number of patients that required Assistance Maneuvers provided by the attending anesthesiologist such as jaw lift, tongue protrusion, laryngeal pressure, etc|<100 seconds||||participants|||Number
2619129|NCT01965938|Secondary|Grade of Glottic View|According to McCormack and Lehane|<100 seconds|data was not collected||||||
2619130|NCT01965938|Secondary|Number of Attempts Performed During Airway Management||<100 seconds||||number attempts||Standard Deviation|Mean
2619131|NCT01965938|Secondary|Number of Participants With Successful Intubation|Successful intubation defined as confirming tube placement by the presence of etCO2;|<100 seconds||||participants|||Number
2619132|NCT01965938|Primary|Time Until Proper Endotracheal Tube Placement|Time (in seconds) from first placement of the intubating scope in the oral cavity until proper endotracheal tube placement is confirmed by the presence of End Tidal Co2 (etCO2). Time to successful intubation was defined as the period from when the tip of the RIFL or FOB passed the incisors until withdrawal past that same point after successful intubation.|usually <100 seconds||||seconds||Inter-Quartile Range|Median
2619133|NCT01965899|Secondary|Survey of the Patient Experience Over Time|"To understand the study subjects' experience with the Reveal LINQ, the patient assistant and the patient home monitor. Patient responses to survey questions will be characterized. Below we will summarize the responses to question Based on your experience to date, please rate your satisfaction with the Reveal LINQ device over 1 month, 6 month, and 12 month follow-up visit."|12 months|"There were 149 patient surveys from 150 1-month follow-up visits collected, 145 surveys from 147 6-month visits, and 143 surveys from 144 12-month visits. Thus, 437 surveys were collected from 441 follow-up visits. The question Based on your experience to date, please rate your satisfaction with the Reveal LINQ device was answered 434 times."|||Percentage of surveys|Participants||Number
2619134|NCT01965899|Secondary|Survey of the Implanting Physicians|"To understand the implanting physicians' experience with the implant of the Reveal LINQ, and the accompanying implanter tools. Responses to survey questions will be characterized. Below we summarize the responses to survey question Overall, how would you rate the ease of entire implant procedure?."|Day of implant|"There have been 151 implant procedures in the study, and 151 physician implant surveys were collected. Of these 151 surveys, 149 answered the question Overall, how would you rate the ease of entire implant procedure?."|||Percentage of surveys|||Number
2619135|NCT01965899|Secondary|Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor|To compare the Reveal LINQ atrial fibrillation detection accuracy with atrial fibrillation detection from Holter monitoring. The true positive rate (sensitivity), specificity, positive predictive value and negative predictive value will be estimated using Holter recordings as the gold standard. Sensitivity measures the proportion of positives that are correctly identified as such. Specificity measures the proportion of negatives that are correctly identified as such. The positive and negative predictive values are the proportion of positive and negative detected patients that are true positive and true negative, respectively. Accuracy measures the proportion of all patients that are correctly identified as negative or positive.|48 hours|A Holter recording was performed in all 150 patients (one patient exited before 1 month), of which 141 were suitable for analysis after excluding recordings with technical issues, such as loss of telemetry or inability to process the data.|||Percentage of patients|||Number
2619136|NCT01965899|Secondary|Safety Endpoint|To characterize the system-related and procedure-related adverse events.|12 months||||Number of events|||Number
2619137|NCT01965899|Secondary|Accuracy of Reveal LINQ Device Detected Atrial Fibrillation|To assess atrial fibrillation detection by the Reveal LINQ insertable cardiac monitor (ICM). True and false positives will be reported.|4 months||||Episodes|Participants||Number
2620705|NCT01953224|Other Pre-specified|Number of Counseling Calls Completed From Baseline to 12 Weeks|Based on counselor logs, we will determine the number of counseling phone calls completed for each participant|12 weeks|||||||
2619141|NCT01965834|Secondary|Proportion of Participants Achieving Progression-Free Survival|Proportion of participants achieving progression-free survival. Measured from date of initiation of treatment (Day 1) to the earliest occurrence of any of the following events: documented disease progression, or death from any cause. Patients who are alive and progression-free will be censored at the date of last documented progression-free status.|6 months, 12 months||||participants|||Number
2619142|NCT01965834|Secondary|Number of Subjects Experiencing Adverse Events|To evaluate safety and tolerability of fenofibrate therapy in patients with multiple myeloma.|Up to 8 months||||participants|||Number
2619143|NCT01965834|Primary|Rate of Response in Participants Receiving Fenofibrate Therapy|To determine response rate (Strict Complete Response (sCR), Complete response (CR), Very Good Partial Response (VgPR), and Partial Response (PR)) in multiple myeloma patients receiving oral fenofibrate therapy. Response will be measured by serum and urine protein electrophoresis and immunofixation, as well as by percentage of plasma cells present on bone marrow biopsy.|After two cycles, about 2 months|No participants achieved response to protocol therapy (Strict Complete Response (sCR), Complete response (CR), Very Good Partial Response (VgPR), or Partial Response (PR)). Two (2) patients had stable disease (SD); one (1) patient achieved Stable Disease/clinical Progressive Disease, and three (3) patients had progressive disease (PD).|||participants|||Number
2619144|NCT01965782|Secondary|Relative Abundance of LY3023703 and the Metabolites of LY3023703 in Plasma||One hour post-dose up to 72 hours post dose|No drug was given or data collected due to the study being terminated.||||||
2619145|NCT01965782|Secondary|Relative Abundance of LY3023703 and the Metabolites of LY3023703 in Urine and Feces||Predose up to 168 hours post dose|No drug was given or data collected due to the study being terminated.||||||
2619146|NCT01965782|Secondary|Pharmacokinetics of LY3023703 and Radioactivity Area Under The Concentration-Time Curve From Time Zero to the Last Timepoint With a Measurable Concentration [AUC (0 to Tlast)]||Predose up to 168 hours post dose|No drug was given or data collected due to the study being terminated.||||||
2619147|NCT01965782|Secondary|Pharmacokinetics of LY3023703 and Radioactivity Time of Maximum Observed Concentration (Tmax)||Predose up to 168 hours post dose|No drug was given or data collected due to the study being terminated.||||||
2619148|NCT01965782|Secondary|Pharmacokinetics of LY3023703 and Radioactivity Maximum Observed Concentration (Cmax)||Predose up to 168 hours post dose|No drug was given or data collected due to the study being terminated.||||||
2619149|NCT01965782|Primary|Urinary Excretion of LY3023703 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered||Predose up to 168 hours post dose|No drug was given or data collected due to the study being terminated.||||||
2619150|NCT01965782|Primary|Fecal Excretion of LY3023703 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered||Predose up to 168 hours post dose|No drug was given or data collected due to the study being terminated.||||||
2619151|NCT01965756|Other Pre-specified|Cerebrospinal Fluid Phosphorylated Tau Concentration||baseline and 8 weeks|CSF was only collected from all participants at baseline and again at week 8 (total of two lumbar punctures). This was pre-specified in the protocol, to ensure adequate tolerability for subjects (total of two lumbar punctures, rather than three). Thus, there is a maximum of 10 data points for each category: 10 for MET-->PBO, and 10 for PBO-->MET|||pg/mL||Standard Deviation|Mean
2619152|NCT01965756|Other Pre-specified|Cerebrospinal Fluid Total Tau Concentration||baseline and 8 weeks|CSF was only collected from all participants at baseline and again at week 8 (total of two lumbar punctures). This was pre-specified in the protocol, to ensure adequate tolerability for subjects (total of two lumbar punctures, rather than three). Thus, there is a maximum of 10 data points for each category: 10 for MET-->PBO, and 10 for PBO-->MET|||pg/mL||Standard Deviation|Mean
2619153|NCT01965756|Other Pre-specified|Cerebrospinal Fluid Amyloid Beta Concentration||baseline and 8 weeks|CSF was only collected from all participants at baseline and again at week 8 (total of two lumbar punctures). This was pre-specified in the protocol, to ensure adequate tolerability for subjects (total of two lumbar punctures, rather than three). Thus, there is a maximum of 10 data points for each category: 10 for MET-->PBO, and 10 for PBO-->MET|||pg/mL||Standard Deviation|Mean
2619154|NCT01965756|Secondary|Trails-B|Standard Trails-B assessment, in which subject is asked to begin at Number 1 and draw a line to Letter A, then to Number 2, then to Letter B, then so forth until he/she reaches the END, without lifting their pencil. They should draw the line as fast as possible, and are timed (in seconds).|16 weeks- measured at baseline, week 8 (crossover), and week 16||||Seconds||Standard Deviation|Mean
2619155|NCT01965756|Primary|Word List Memory Total - ADAS-cog|Alzheimer's Disease Assessment Scale- Cognitive Sub scale (ADAS-COG). Three trials of 10 words each (30 words total)|16 weeks (total) - measured at baseline, week 8 (crossover), and week 16||||Words recalled||Standard Deviation|Mean
2619156|NCT01965665|Primary|Change in Sepsis Rate|Patients will be assessed weekly for sepsis or until frame is removed.|weekly from baseline until frame removal, up to 16 weeks|Data not collected||||||
2619157|NCT01965665|Primary|Number of Patients With Pin Site Infection|Patients will be assessed weekly for pin site infection up until frame removal.|weekly from baseline until frame removal, up to 16 weeks||||participants|||Number
2619158|NCT01965665|Primary|Total Number of Pin Sites|total number of pin sites for all patients enrolled|Day of surgical intervention approximately 3hrs.||||total number of pin sites|||Number
2619159|NCT01965652|Secondary|Participant Global Satisfaction|"Participants were asked to rate their degree of satisfaction of constipation and abdominal symptoms from the start of study drug dosing to Week 52 (or early termination).~Satisfaction was rated based on the following seven grades:~Grade 1 = markedly worsened~Grade 2 = moderately worsened~Grade 3 = slightly worsened~Grade 4 = unchanged~Grade 5 = slightly improved~Grade 6 = moderately improved~Grade 7 = markedly improved"|Week 52 or early termination visit|Intent-to-treat population|||percentage of participants|||Number
2619193|NCT01965431|Secondary|Maximum Mean Placebo-corrected HR Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy|Maximum mean placebo-corrected heart rate (HR) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. HR was derived from the RR interval.|20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1|ECG analysis set (ECGS)|||bpm||Standard Error|Mean
2619160|NCT01965652|Secondary|Change From Baseline in the Satisfaction Domain of PAC-QOL|"The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants' daily life during the past 2 weeks.~Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The satisfaction domain consists of 5 questions related to participants' feelings of satisfaction with their bowel function. The satisfaction domain score was calculated as the mean of the 5 individual scores. A negative change from baseline value indicates improvement."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
2619161|NCT01965652|Secondary|Change From Baseline in the Worries and Concerns Domain of PAC-QOL|"The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants' daily life during the past 2 weeks.~Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The worries and concerns domain consists of 11 questions related to participants' feelings and concerns about their constipation. The worries and concerns domain score was calculated as the mean of the 11 individual scores. A negative change from baseline value indicates improvement."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
2619162|NCT01965652|Secondary|Change From Baseline in the Psychosocial Discomfort Domain of PAC-QOL|"The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants' daily life during the past 2 weeks.~Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The psychosocial discomfort domain consists of 8 questions related to participants' embarrassment regarding their constipation and effects of constipation on eating habits and appetite.~The psychosocial discomfort score was calculated as the mean of the 8 individual scores. A negative change from baseline value indicates improvement."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
2619163|NCT01965652|Secondary|Change From Baseline in the Physical Discomfort Domain of PAC-QOL|"The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants' daily life during the past 2 weeks.~Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The physical discomfort domain consists of 4 questions related to bloating, feeling heavy, how much of the time participants felt any physical discomfort and how much time they felt the need to open their bowel but were not able to. The physical discomfort score was calculated as the mean of the 4 individual scores. A negative change from baseline value indicates improvement."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
2619164|NCT01965652|Secondary|Change From Baseline in the Patient Assessment of Constipation Quality of Life Overall Score|"The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) consists of 28 questions designed to measure the impact constipation has had on participants' daily life during the past 2 weeks.~Each question was evaluated by the participant on a five-point scale ranging from 0 (not at all or none of the time) to 4 (extremely or all of the time), where higher scores represent poorer quality of life. The overall score was calculated as the mean of all 28 item scores. A negative change from baseline value indicates improvement."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat|||units on a scale||Standard Error|Least Squares Mean
2619165|NCT01965652|Secondary|Change From Baseline in the PAC-SYM Stool-symptoms Domain Score|"The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) asked participants to rate the severity of 12 constipation symptoms in the last 2 weeks on a scale from 0 (absent) to 4 (very severe). The stool-symptom domain score was calculated as the mean of the following 5 items: incomplete bowel movements, bowel movements that were too hard, bowel movements that were too small, straining or squeezing to try to pass bowel movements, and false-alarm bowel movements.~A negative change from baseline value indicates improvement in symptoms."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
2619166|NCT01965652|Secondary|Change From Baseline in the PAC-SYM Rectal-symptoms Domain Score|The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) asked participants to rate the severity of 12 constipation symptoms in the last 2 weeks on a scale from 0 (absent) to 4 (very severe). The abdominal-symptom domain score was calculated as the mean of the following 3 items: painful bowel movements, rectal burning during or after a bowel movement, and rectal bleeding or tearing during or after a bowel movement. A negative change from baseline value indicates improvement in symptoms.|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
2619167|NCT01965652|Secondary|Change From Baseline in the PAC-SYM Abdominal-symptoms Domain Score|"The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) asked participants to rate the severity of 12 constipation symptoms in the last 2 weeks on a scale from 0 (absent) to 4 (very severe). The abdominal-symptom domain score was calculated as the mean of the following 4 items: abdominal discomfort, abdominal pain, abdominal bloating and stomach cramps.~A negative change from baseline value indicates improvement in symptoms."|Baseline and Weeks 2, 12, 24, 36, and 52|Intent-to-treat population|||units on a scale||Standard Error|Least Squares Mean
2619168|NCT01965652|Secondary|Change From Baseline in the Overall Score for Patient Assessment of Constipation Symptoms|The Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) asked participants to rate the severity of 12 constipation symptoms in the last 2 weeks on a scale from 0 (absent) to 4 (very severe). The overall score was calculated as the mean of all 12 items and ranges from 0 (best) to 4 (worst). A negative change from baseline value indicates improvement.|Baseline and Weeks 2, 12, 24, 36, and 52|The intent-to-treat population includes all randomized participants. Five participants were excluded due to double enrollment at different sites.|||units on a scale||Standard Error|Least Squares Mean
2620706|NCT01953224|Other Pre-specified|Frequency of App Use Over 12 Weeks|Based on objective measures taken from individual game accounts, we will determine the discrete number of uses of the game app|12 weeks|||||||
2619169|NCT01965652|Secondary|Percentage of Participants Meeting Each Criterion of Laxative Use|"Participants who were taking stable routine/regular laxatives at Screening were to continue taking the same regimen throughout the study.~The percentage of participants meeting each of the criteria below are reported:~1. Participants not on stable laxatives, defined as participants who did not use laxatives from 28 days prior to the Screening Period to the final dose of study drug or who received only rescue laxative. Rescue is defined as any laxative taken for the first time during the Treatment Period.~1a. Out of participants who were not on stable laxatives, participants who received rescue laxatives.~2. Participants on stable laxatives, defined as participants who may have had at least one/any stable laxative use reported from 28 days prior to Screening Period to the final dose of study drug.~2a. Out of participants who were on stable laxatives, participants who received rescue laxatives.~3. Participants who did not meet criteria 1 or 2."|From 28 days prior to screening until the end of the treatment period (total of 56 weeks)|Intent-to-treat population|||percentage of participants|||Number
2619170|NCT01965652|Secondary|Change From Baseline in the Number of Bowel Movements Per Week|Participants monitored their bowel movements and completed a daily bowel habits diary the week prior to study visits (i.e. during Weeks 11, 23, 35, and 51).|Baseline and Weeks 12, 24, 36, and 52|The intent-to-treat population includes all randomized participants. Five participants were excluded due to double enrollment at different sites.|||bowel movements / week||Standard Error|Least Squares Mean
2619171|NCT01965652|Primary|Number of Participants With Adverse Events|"A serious adverse event was defined as any adverse event (AE) that resulted in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization were considered an SAE when, based upon appropriate medical judgment, they jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Adverse drug reactions (ADRs) were defined as adverse events that were considered by the investigator to be definitely, probably, or possibly related to study drug. Serious ADRs were defined as serious AEs considered by the investigator to be definitely, probably, or possibly related to study drug."|From the first dose of study drug up to 14 days after the last dose of study drug (54 weeks).|Safety population|||participants|||Number
2619172|NCT01965600|Secondary|Time to Cmax (Tmax) of PF-06282999||Day 3|Due to early termination of the study, no data was collected for this endpoint.||||||
2619173|NCT01965600|Secondary|Area Under the Concentration-time Profile From Time 0 to End of Dosing Interval, Tau (AUCtau) of PF-06282999||Day 3|Due to early termination of the study, no data was collected for this endpoint.||||||
2619174|NCT01965600|Secondary|Maximum Plasma Concentration (Cmax) of PF-06282999||Day 3|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.||||||
2619175|NCT01965600|Secondary|Peak (AUC0.5-2hours and AUC0-2hours) of MPO Activity/MPO Mass|MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.|Days 1, 3-5|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.||||||
2619176|NCT01965600|Secondary|Concentrations of TNF-alpha, IL-1 Beta, IL-6, IL-8, and hsCRP|The effect of multiple oral doses of PF-06282999 on inflammatory biomarkers was a secondary objective in this study. The biomarkers are tumor necrosis factor (TNF)-alpha, interleukin (IL)-1 beta, IL-6, IL-8, and high-sensitivity C-reactive protein (hsCRP).|Days 1, 3, and 4|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.||||||
2619177|NCT01965600|Primary|Number of Participants With Abnormal Urinary Biomarker Values|Urinary biomarkers included albumin, neutrophil gelatinase-associated lipocalin (NGAL) and Cystatin-C.|Days 1-3 prior to dosing with PF-06282999/Placebo; and Days 4-5|Analysis not done due to early termination of study.||||||
2619178|NCT01965600|Primary|Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria|Criteria for ECG (12-lead) values meeting categorical summarization criteria were: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval >=300 milliseconds (msec) and increase from baseline >=25/50%; time from the beginning of the ECG Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec and increase of >=50%; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval >=500 msec; QT corrected using the Fridericia formula (QTcF) of 450 to <480 msec, 480 to <500 msec, and >=500 msec, or an increase of 30 to <60 msec or >=60 msec. Due to early termination of the study, only ECG data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.|Screening; Days 1-5 and approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2|All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings.|||participants|||Number
2619179|NCT01965600|Primary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria|Categorical summarization criteria in vital signs included: sitting, supine, and standing systolic blood pressure (SBP) of less than (<)90 millimeters of mercury (mm Hg) or change (increase [inc] or decrease [dec]) in sitting, supine and standing SBP of more than or equal to (>=)30 mm Hg; supine, sitting, and standing diastolic blood pressure (DBP) of <50 mm Hg or change (inc or dec) in sitting, supine, and standing DBP of >=20 mm Hg; supine and sitting pulse rate (PR) of <40 or more than (>)120 beats per minute (bpm); and standing PR of <40 or >140 bpm. Due to early termination of the study, only vital signs data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.|Screening and Days 1-2, 4-5, and approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2 for orthostatic (orth) measurements; Day 3 for supine measurements|All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings. n=number of participants evaluable for that parameter|||participants|||Number
2619180|NCT01965600|Primary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy). Due to early termination of the study, only laboratory data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.|Baseline up to 7-10 days following the last dose of PF-06282999/Placebo in Period 2|All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings.|||participants|||Number
2619181|NCT01965600|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as newly occurring AEs or those worsening after first dose. Due to early termination of the study, only AE data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.|From Day 0 till approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2 (up to approximately 2 months)|All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings.|||participants|||Number
2619182|NCT01965600|Primary|MPO Activity (Area Under the Concentration-time Profile From 0 to 2 Hours [AUC0-2hrs]) Following Inflammatory Stimulus|MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.|Days 1, 3-5|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.||||||
2619183|NCT01965600|Primary|MPO Activity (Area Under the Concentration-time Profile From 0.5 to 2 Hours [AUC0.5-2hrs]) Following Inflammatory Stimulus|MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.|Days 1, 3-5|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.||||||
2619184|NCT01965600|Primary|Peak Myeloperoxidase (MPO) Activity Following Inflammatory Stimulus|MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.|Days 1, 3-5|Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.||||||
2619185|NCT01965561|Secondary|Pain During Tourniquet Application|Pain during tourniquet application as measured on a visual analog scale (VAS). The pain scale was a 100-mm-long line on a piece of paper. The subject made a cross mark on the line, which went from the left limit (0 mm) at no pain to the right limit (100 mm) at very severe pain.|1 minute||||mm on VAS||Standard Deviation|Mean
2619186|NCT01965561|Primary|Effectiveness at Stopping Distal Pulse|Percentage of participants whose distal pulse ceased within 1 minute of junctional tourniquet application.|1 min||||percentage of participants|||Number
2619187|NCT01965535|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure is defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2619188|NCT01965535|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12||Baseline; Weeks 1, 2, 4, 8, and 12|Participants in Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2619189|NCT01965535|Secondary|Percentage of Participants With HCV RNA < LLOQ (ie, < 25 IU/mL) at Weeks 1, 2, 4, 8, 12, and 24||Weeks 1, 2, 4, 8, 12, and 24|Full Analysis Set|||percentage of participants|||Number
2619190|NCT01965535|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
2619191|NCT01965535|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|"SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.~1 participant who was randomized to the LDV/SOF + RBV group who received placebo discontinued prior to receiving LDV/SOF + RBV and is excluded from the Full Analysis Set.~1 participant who was randomized to the LDV/SOF + RBV group received LDV/SOF + placebo, and is counted in the LDV/SOF group for the safety analysis, and in the LDV/SOF+RBV group for the efficacy analysis (ie, in the Full Analysis Set)."|Posttreatment Week 12|Full Analysis Set: participant with genotype 1 HCV infection who were randomized and received at least 1 dose of active study drug.|||percentage of participants|||Number
2619192|NCT01965431|Secondary|Minimum Mean Placebo-corrected HR (Heart Rate) Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy|Minimum mean placebo-corrected HR (heart rate) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated. HR was derived from the RR interval.|20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1|ECG analysis set (ECGS)|||bpm||Standard Error|Mean
2620707|NCT01953224|Other Pre-specified|Acceptability|Acceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability|12 weeks|||||||
2619194|NCT01965431|Secondary|Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 6 Hours on Day 1 for the Moxifloxacin Treatment|"Maximum mean placebo-corrected QTcN change from baseline between 1 to 6 hours on Day 1 for the Moxifloxacin treatment is estimated.~QTcN denotes the population heart rate corrected QT interval length, based on a parabolic model. 'Baseline' denotes the mean of the pre-dose ECG measurements prior to (first) dose at Visits 2, 3 or 4, determined separately for each treatment period. 'Global baseline' refers to the mean of all available period baseline values."|20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h and 6h after drug adminstration on day 1|ECG analysis set (ECGS)|||ms||Standard Error|Mean
2619195|NCT01965431|Primary|Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy|"Maximum mean placebo-corrected QT interval corrected for heart rate according to a parabolic population model (QTcN) change from baseline between 1 to 24 hours on Day 1 for the combination therapy is estimated.~QTcN denotes the population heart rate corrected QT interval length, based on a parabolic model. 'Baseline' denotes the mean of the pre-dose ECG measurements prior to (first) dose at Visits 2, 3 or 4, determined separately for each treatment period. 'Global baseline' refers to the mean of all available period baseline values."|20min,15min and 10min prior to drug administration on day -2 (baseline) and 1h (hours), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h and 24h after drug adminstration on day 1|Electrocardiogram (ECG) analysis set (ECGS): all subjects in the treated set who had at least 1 baseline and post-baseline assessment for at least 1 ECG endpoint.|||ms||Standard Error|Mean
2619196|NCT01965366|Secondary|Change in The PTSD Symptom Scale Scores|"The PTSD Symptom Scale (PSS) is a 17-item interview used to aid in the detection and diagnosis of PTSD. The structure and content of the PSS mirror the DSM-IV criteria for PTSD. For each item, the interviewer assigns a rating to reflect a combination of frequency and severity (from O = not at all to 3 = 5 or more times per week/very much). Scores range from 0-51, with higher scores indicating more reported symptoms of PTSD. A score of 13 or higher indicates the likelihood of PTSD."|Baseline and immediate post treatment (up to 12 weeks from baseline)||||units on a scale||Standard Deviation|Mean
2619197|NCT01965366|Primary|Change in The Clinician Administered PTSD Scale (CAPS)Scores|The Clinician Administered PTSD Scale (CAPS) provides a diagnostic measure of PTSD and a continuous measure of the severity, frequency, and intensity of the three symptom clusters (intrusion, avoidance, and arousal) and overall PTSD. The assessor combines information about frequency and intensity of an item into a single severity rating. Severity Rating: 0. Absent; 1. Mild / subthreshold;2. Moderate / threshold; 3. Severe / markedly elevated; 4.Extreme / incapacitating. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Scores may range from 0-80, with a higher score indicating more reported symptoms of PTSD.|Baseline and immediate post treatment (up to 12 weeks from baseline)||||units on a scale||Standard Deviation|Mean
2619198|NCT01965327|Secondary|Change in Total Friedreich Ataxia Rating Scale (FARS) Score|The Friedreich Ataxia Rating Scale (FARS) is neurological rating scale specifically developed and validated for FRDA. The FARS includes assessments of stance, gait, upper and lower limb coordination, speech, proprioception and strength. In addition to the standard neurological examination, the FARS contains three quantitative performance measures and a component that assesses activities of daily living (ADL). Quantitative performance measures include the nine-hole peg test, and a timed 25-foot walk. FARS scores correlate significantly with functional disability, activities of daily living scores and disease duration. The scores from the three subscales are added to generate a total score ranging from 0 to 159, with a higher score indicating a greater level of disability.|FARS score was calculated at the beginning and conclusion of treatment (baseline and 12 weeks)|The analysis was based on an intent-to-treat approach and included all subjects with baseline FARS assessment.|||units on a scale||Standard Deviation|Mean
2619199|NCT01965327|Primary|Change in Whole Blood Frataxin Levels|Assessment of the change in whole blood frataxin levels as assessed by lateral flow assay using an immunoassay for frataxin. Frataxin levels in the blood were measured at each study visit. Change in frataxin level at the end of treatment (week 12) relative to frataxin level at baseline was analyzed.|Frataxin levels were measured at the beginning and conclusion of treatment (baseline and 12 weeks)|The primary analysis was based on an intent-to-treat approach including all subjects who had baseline frataxin blood levels collected.|||percentage of baseline frataxin level||Standard Deviation|Mean
2619200|NCT01965288|Secondary|Participant Preference for Either of the Study Lenses|"Percentage of participants that answer the question, Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance? Collected at study end. (Forced choice; first study lenses, second study lenses, neither)"|8 weeks|All 60 subjects wore habitual lenses prior to randomization of study lenses.|||percentage of participants|||Number
2619201|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or Either of the Study Lenses|"Percentage of participants that answer the question, Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance? Collected at study end. (Forced choice; habitual lenses, first study lenses, second study lenses)"|8 weeks|All 60 subjects wore habitual lenses prior to randomization of study lenses.|||percentage of participants|||Number
2619202|NCT01965288|Secondary|Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues.|"Percentage of participants that answer the question, How likely are they to recommend either the first pair of study lenses or the second pair of study lenses to friends, family or colleagues? Collected at study end. (4 point Likert scale; very likely, likely, unlikely, very unlikely)"|8 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619203|NCT01965288|Secondary|Participant Recommendation of a Study Lens to Friends, Family or Colleagues|"Percentage of participants that answer the question, What study lens they will most likely recommend to friends, family or colleagues? Collected at end of study. (Forced choice; First Study Lenses, Second Study Lenses)"|8 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619204|NCT01965288|Secondary|Participants Likelihood of Continuing to Wear the Study Lenses.|"Participants likelihood of continuing to wear either of the pairs of study lenses when asked; How likely are they to continue to wearing either the first study lenses or the second study lenses? Collected at 4 weeks fore each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)"|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619205|NCT01965288|Secondary|Participants Likelihood of Switching From Habitual Lenses to the Study Lenses|"Participants likelihood of switching from habitual lenses to either pair of the study lenses when asked; How likely are they to switch from their habitual lenses to either the first study lenses or the second study lenses? Collected at 4 weeks for each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)"|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of particpants|||Number
2619206|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)|Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)|4 weeks|All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.|||percentage of participants|||Number
2619207|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)|Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)|4 weeks|All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.|||percentage of participants|||Number
2619208|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)|Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)|2 weeks|All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.|||percentage of patients|||Number
2619209|NCT01965288|Secondary|Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)|Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)|2 weeks|All 60 subjects were habitual lense wearers and randomized to both sets of study lenses.|||percentage of patients|||Number
2619210|NCT01965288|Secondary|Corneal Infiltrates|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
2619211|NCT01965288|Secondary|Corneal Infiltrates|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
2619212|NCT01965288|Secondary|Corneal Infiltrates|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
2619213|NCT01965288|Primary|Overall Fit Acceptance|Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 4 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619214|NCT01965288|Primary|Overall Fit Acceptance|Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 2 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619215|NCT01965288|Primary|Overall Stability|Assessment of Lens Fit Performance for overall lens stability. Collected at 4 weeks for each lens. (Excellent or Good.|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619216|NCT01965288|Primary|Overall Stability|Assessment of Lens Fit Performance for overall lens stability. Collected at 2 weeks for each lens. (Excellent or Good.|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619217|NCT01965288|Secondary|Corneal Neovascularization|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
2619218|NCT01965288|Secondary|Corneal Neovascularization|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
2619219|NCT01965288|Secondary|Corneal Neovascularization|Investigators' objective assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
2619220|NCT01965288|Secondary|Corneal Stromal Haze|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
2619221|NCT01965288|Secondary|Corneal Stromal Haze|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
2619222|NCT01965288|Secondary|Corneal Stromal Haze|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
2619223|NCT01965288|Secondary|Lower Palpebral Hyperaemia|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
2619226|NCT01965288|Secondary|Bulbar Hyperaemia|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
2619227|NCT01965288|Secondary|Bulbar Hyperaemia|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
2619228|NCT01965288|Secondary|Bulbar Hyperaemia|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
2619229|NCT01965288|Secondary|Limbal Hyperaemia|Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
2619230|NCT01965288|Secondary|Limbal Hyperaemia|Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of eyes|Participants||Number
2619231|NCT01965288|Primary|Lens Stability 5-10 Min|Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 4 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619232|NCT01965288|Primary|Lens Stability 5-10 Min|Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 2 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619233|NCT01965288|Primary|Lens Stability on Blink|Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 4 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619234|NCT01965288|Primary|Lens Stability on Blink|Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 2 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619235|NCT01965288|Primary|Lens Marking Visibility|Assessment of Lens Fit Performance for lens marking visibility. Collected at 4 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619236|NCT01965288|Primary|Lens Marking Visibility|Assessment of Lens Fit Performance for lens marking visibility. Collected at 2 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619237|NCT01965288|Primary|Post Blink Movement|Assessment of Lens Fit Performance for post blink movement. Collected at 4 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)|4 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale|Participants|Standard Deviation|Mean
2619238|NCT01965288|Primary|Post Blink Movement|Assessment of Lens Fit Performance for post blink movement. Collected at 2 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)|2 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale|Participants|Standard Deviation|Mean
2619239|NCT01965288|Primary|Corneal Coverage|Assessment of Lens Fit Performance for corneal coverage. Collected at 4 weeks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619240|NCT01965288|Primary|Corneal Coverage|Assessment of Lens Fit Performance for corneal coverage. Collected at 2 weks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619241|NCT01965288|Primary|Centration|Assessment of Lens Fit Performance for centration. Collected at 4 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619242|NCT01965288|Primary|Centration|Assessment of Lens Fit Performance for centration. Collected at 2 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619243|NCT01965288|Primary|Lens Surface Deposits|Assessment of lens front surface deposits. Collected at 4 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)|4 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale|Participants|Standard Deviation|Mean
2619244|NCT01965288|Primary|Lens Surface Deposits|Assessment of lens front surface deposits. Collected at 2 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)|2 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale|Participants|Standard Deviation|Mean
2619245|NCT01965288|Primary|Rotational Recovery 30/45 Deg|Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)|4 weeks|All 60 subjects randomized to both sets of lenses.|||degrees|Participants|Standard Deviation|Mean
2619246|NCT01965288|Primary|Rotational Recovery 30/45 Deg|Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)|2 weeks|All 60 subjects randomized to both sets of lenses.|||degrees|Participants|Standard Deviation|Mean
2619247|NCT01965288|Primary|Lens Orientation Primary Gaze|Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 4 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)|4 weeks|All 60 subjects randomized to both sets of lenses.|||degrees|Participants|Standard Deviation|Mean
2619248|NCT01965288|Primary|Lens Orientation Primary Gaze|Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 2 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)|2 weeks|All 60 subjects randomized to both sets of lenses.|||degrees|Participants|Standard Deviation|Mean
2619249|NCT01965288|Primary|Visual Acuity logMAR|"Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 4 weeks for each lens. logMAR (VA).~Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)"|4 Weeks|All 60 subjects randomized to both sets of lenses.|||logMAR||Standard Deviation|Log Mean
2619250|NCT01965288|Primary|Visual Acuity logMAR|"Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 2 weeks for each lens. logMAR (VA).~Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)"|2 Weeks|All 60 subjects randomized to both sets of lenses.|||logMAR||Standard Deviation|Log Mean
2619251|NCT01965288|Primary|Wavefront Aberrations RMS (5mm)|Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).|4 Weeks|All 60 subjects randomized to both sets of lenses.|||microns|Participants|Standard Deviation|Mean
2619252|NCT01965288|Primary|Wavefront Aberrations RMS (5mm)|Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).|2 Weeks|All 60 subjects randomized to both sets of lenses.|||microns|Participants|Standard Deviation|Mean
2619253|NCT01965288|Primary|Wavefront Aberrations RMS (3mm)|Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).|4 Weeks|All 60 subjects randomized to both sets of lenses.|||microns|Participants|Standard Deviation|Mean
2619254|NCT01965288|Primary|Wavefront Aberrations Root Mean Square (RMS) (3mm)|Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).|2 Weeks|All 60 subjects randomized to both sets of lenses.|||microns|Participants|Standard Deviation|Mean
2619255|NCT01965288|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619256|NCT01965288|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619257|NCT01965288|Primary|Lens Fit Satisfaction|Participant rating for lens fit satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619258|NCT01965288|Primary|Lens Fit Satisfaction|Participant rating for lens fit satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619259|NCT01965288|Primary|Vision Satisfaction|Participant rating for vision satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619260|NCT01965288|Primary|Vision Satisfaction|Participant rating for vision satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619261|NCT01965288|Primary|Handling Satisfaction|Participant rating for handling satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619262|NCT01965288|Primary|Handling Satisfaction|Participant rating for handling satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619263|NCT01965288|Primary|Dryness Satisfaction|Participant rating for dryness satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619264|NCT01965288|Primary|Dryness Satisfaction|Participant rating for dryness satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619265|NCT01965288|Primary|Comfort Satisfaction|Participant rating for comfort satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619266|NCT01965288|Primary|Comfort Satisfaction|Participant rating for comfort satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619267|NCT01965288|Primary|Overall Sensation of Smoothness|Participant rating for overall sensation of smoothness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619268|NCT01965288|Primary|Overall Sensation of Smoothness|Participant rating for overall sensation of smoothness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619269|NCT01965288|Primary|Overall Sensation of Moistness|Participant rating for overall sensation of moistness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)|4 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619270|NCT01965288|Primary|Overall Sensation of Moistness|Participant rating for overall sensation of moistness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)|2 weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619271|NCT01965288|Primary|Vision Stability on Insertion, During Day, End Day|Participant rating of vision stability on insertion, during the day, end of day. Collected at 4 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)|4 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
2619272|NCT01965288|Primary|Vision Stability on Insertion, During Day, End Day|Participant rating of vision stability on insertion, during the day, end of day. Collected at 2 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)|2 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
2619273|NCT01965288|Primary|Vision Quality Insertion, During Day, End Day, Night|Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 4 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|4 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
2619274|NCT01965288|Primary|Vision Quality Insertion, During Day, End Day, Night|Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 2 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|2 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
2619275|NCT01965288|Primary|Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction|Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 4 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)|4 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
2619276|NCT01965288|Primary|Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction|Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 2 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)|2 weeks|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
2619277|NCT01965288|Primary|Participants Use of Rewetting Drops|Proportion of subjects using rewetting drops. Collected at 4 weeks for each lens. (Yes, No)|4 Weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619278|NCT01965288|Primary|Participants Use of Rewetting Drops|Proportion of subjects using rewetting drops. Collected at 2 weeks for each lens. (Yes, No)|2 Weeks|All 60 subjects randomized to both sets of lenses.|||percentage of participants|||Number
2619279|NCT01965288|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at 4 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)|4 weeks|All 60 subjects randomized to both sets of lenses.|||hours||Standard Deviation|Mean
2619280|NCT01965288|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at 2 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)|2 weeks|All 60 subjects randomized to both sets of lenses.|||hours||Standard Deviation|Mean
2619281|NCT01965288|Primary|Overall Fit Acceptance|Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at dispense for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)|Dispense|All 60 subjects randomized to both sets of lenses.|||percentage of lenses fitted|Participants||Number
2619282|NCT01965288|Primary|Rotational Recovery 30/45 Deg|Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at dispense for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)|Dispense|All 60 subjects randomized to both sets of lenses.|||degrees|Participants|Standard Deviation|Mean
2619283|NCT01965288|Primary|Lens Overall Stability|Assessment of Lens Fit Performance for overall lens stability. Collected at dispense for each lens. (Excellent or Good)|Dispense|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619284|NCT01965288|Primary|Lens Stability 5-10 Min|Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at dispense for each lens. (Varied less than 5 degrees from lens marking location between 5-10 min)|Dispense|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619285|NCT01965288|Primary|Lens Stability on Blink|Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at dispense for each lens. (No rotation and 5-10 degrees rotation from axis location mark)|Dispense|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619286|NCT01965288|Primary|Lens Marking Visibility|Assessment of Lens Fit Performance for lens marking visibility. Collected at dispense for each lens. (1-3, 1=excellent, 2=average, 3=poor)|Dispense|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619287|NCT01965288|Primary|Lens Orientation Primary Gaze|Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Collected at dispense for each lens. (Degree of mislocation relative to lens axis mark.)|Dispense|All 60 subjects randomized to both sets of lenses.|||degrees|Participants|Standard Deviation|Mean
2619288|NCT01965288|Primary|Post Blink Movement|Assessment of Lens Fit Performance for post blink movement. Collected at dispense for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)|Dispense|All 60 subjects randomized to both sets of lenses.|||units on a scale|Participants|Standard Deviation|Mean
2619289|NCT01965288|Primary|Corneal Coverage|Assessment of Lens Fit Performance for corneal coverage. Collected at dispense for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)|Dispense|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619290|NCT01965288|Primary|Centration|Assessment of Lens Fit Performance for centration. Collected at dispense for each lens. (Biomicroscopy; centered or slightly decentered)|Dispense|All 60 subjects randomized to both sets of lenses.|||percentage of lenses|Participants||Number
2619291|NCT01965288|Primary|Visual Acuity logMAR|Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at dispense for each lens. logMAR (VA).|Dispense|All 60 subjects randomized to both sets of lenses.|||logMAR|Participants|Standard Deviation|Log Mean
2619292|NCT01965288|Primary|Vision Stability Upon Contact Lens Insertion|Participant rating of vision stability on insertion. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|Dispense|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
2619293|NCT01965288|Primary|Vision Quality With Contact Lens Prescription|Participant rating of Vision Quality with contact lens prescription. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|Dispense|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
2619294|NCT01965288|Primary|Vision Satisfaction Upon Contact Lens Insertion|Participant rating of vision satisfaction upon insertion. Collected at dispense for each lens. (0-10; 10= Very Satisfied)|Dispense|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
2619295|NCT01965288|Primary|Comfort Upon Contact Lens Insertion|Participant rating of comfort upon insertion. Collected at dispense for each lens. (0-10; 10=Can't Feel)|Dispense|All 60 subjects randomized to both sets of lenses.|||units on a scale||Standard Deviation|Mean
2619296|NCT01965288|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline||||percentage of participants|||Number
2619297|NCT01965288|Primary|Vision Satisfaction|Participant rating for vision satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline||||percentage of participants|||Number
2619298|NCT01965288|Primary|Lens Fit Satisfaction|Participant rating for lens fit satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline||||percentage of participants|||Number
2619299|NCT01965288|Primary|Handling Satisfaction|Participant rating for handling satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline||||percentage of participants|||Number
2619300|NCT01965288|Primary|Dryness Satisfaction|Participant rating for dryness satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline||||percentage of participants|||Number
2619301|NCT01965288|Primary|Comfort Satisfaction|Participant rating for comfort satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)|Baseline||||percentage of participants|||Number
2619302|NCT01965288|Primary|Overall Sensation of Smoothness|Participant rating for overall sensation of smoothness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)|Baseline||||percentage of participants|||Number
2619303|NCT01965288|Primary|Overall Sensation of Moistness|Participant rating for overall sensation of moistness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)|Baseline||||percentage of subjects|||Number
2619304|NCT01965288|Primary|Vision Stability Insertion, During Day, End Day|Participant rating of vision stability on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)|Baseline||||units on a scale||Standard Deviation|Mean
2619305|NCT01965288|Primary|Vision Quality Insertion, During Day, End Day|Participant rating of vision quality on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)|Baseline||||units on a scale||Standard Deviation|Mean
2619306|NCT01965288|Primary|Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction|Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at baseline for all habitual lenses. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)|Baseline||||units on a scale||Standard Deviation|Mean
2619307|NCT01965288|Secondary|Limbal Hyperaemia|Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)|Baseline||||percentage of eyes|Participants||Number
2619308|NCT01965288|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses. (The hours of average comfortable wearing time and average daily wearing time.)|Baseline||||hours||Standard Deviation|Mean
2619309|NCT01965262|Primary|Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.|1 week|11 subjects discontinued the study. Missing data of 1 subject for hema-copolymer group.|||units on a scale||Standard Deviation|Mean
2619310|NCT01965262|Primary|Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.|Baseline|8 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
2619311|NCT01965262|Primary|Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.|1 week|11 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
2619312|NCT01965262|Primary|Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.|Baseline|8 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
2619313|NCT01965262|Primary|Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of handling (ease of insertion and ease of removal) for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unmanageable, 100= excellent.|1 week|11 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
2619314|NCT01965262|Primary|Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of ocular redness for hema-copolymer and etafilcon A lenses lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.|1 week|11 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
2619315|NCT01965262|Primary|Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of peripheral blur assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.|1 week|11 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
2619316|NCT01965262|Primary|Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of peripheral blur is assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.|Baseline|8 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
2619317|NCT01965262|Primary|Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.|1 week|11 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
2619318|NCT01965262|Primary|Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.|Baseline|8 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
2619319|NCT01965262|Primary|Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of comfort preference after insertion and before removal for hema-copolymer and etafilcon A lenses is assessed at 1 week. Scale 0-100, 0=causes pain, 100= excellent.|1 week|11 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
2619320|NCT01965262|Primary|Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A|Subjective Assessment of comfort preference for hema-copolymer and etafilcon A assessed at baseline. Scale 0-100, 0=causes pain, 100= excellent.|Baseline|7 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
2619321|NCT01965262|Primary|Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A|Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive|1 week|11 subjects discontinued the study.|||Eyes|Eyes||Number
2619322|NCT01965262|Primary|Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A|Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive|Baseline|All 30 subjects were dispensed lenses, and lens movement measurements were obtained at baseline.|||Eyes|Eyes||Number
2619323|NCT01965262|Primary|Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A|Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive|1 week|11 subjects discontinued the study.|||Eyes|Eyes||Number
2619324|NCT01965262|Primary|Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A|Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive|Baseline|All 30 subjects were dispensed lenses, and lens fit of corneal centration measurements were obtained at baseline.|||Eyes|Eyes||Number
2619325|NCT01965262|Primary|Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A|Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior|1 week|11 subjects discontinued the study.|||Eyes|Eyes||Number
2619326|NCT01965262|Primary|Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A|Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior|Baseline|All 30 subjects were dispensed lenses, and lens fit of vertical centration measurements were obtained at baseline.|||Eyes|Eyes||Number
2619327|NCT01965262|Primary|Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A|Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal|1 week|11 subjects discontinued the study.|||Eyes|Eyes||Number
2619328|NCT01965262|Primary|Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A|Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal|Baseline|All 30 subjects were dispensed lenses, and lens fit of horizontal centration measurements were obtained at baseline.|||Eyes|Eyes||Number
2619329|NCT01965262|Primary|Lens Surface - Wettability - Hema-copolymer and Etafilcon A|Lens surface of wettability for hema-copolymer and etafilcon A pair lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.|1 week|11 subjects discontinued the study.|||participants|||Number
2619330|NCT01965262|Primary|Lens Surface - Wettability - Hema-copolymer and Etafilcon A|Lens surface of wettability for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.|Baseline|All 30 subjects were dispensed lenses, and lens surface of wettability measurements were obtained at baseline.|||participants|||Number
2619331|NCT01965262|Primary|Lens Surface - Debris - Hema-copolymer and Etafilcon A|Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.|1 week|11 subjects discontinued the study.|||participants|||Number
2619332|NCT01965262|Primary|Lens Surface - Debris - Hema-copolymer and Etafilcon A|Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.|Baseline|All 30 subjects were dispensed lenses, and lens surface of debris measurements were obtained at baseline.|||participants|||Number
2619333|NCT01965262|Primary|Lens Surface - Deposition - Hema-copolymer and Etafilcon A|Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.|1 week|11 subjects discontinued the study.|||participants|||Number
2619334|NCT01965262|Primary|Lens Surface - Deposition - Hema-copolymer and Etafilcon A|Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.|Baseline|All 30 subjects were dispensed lenses, and lens surface of deposition measurements were obtained at baseline.|||participants|||Number
2619335|NCT01965262|Primary|Biomicroscopy - Hema-copolymer and Etafilcon A|Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe).|1 week|11 subjects discontinued the study.|||units on a scale||Standard Deviation|Mean
2619336|NCT01965262|Primary|Visual Acuity - Hema-copolymer and Etafilcon A|Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week.|1 week|11 subjects discontinued the study. Missing data of 1 subject for hema-copolymer group.|||logMAR||Standard Deviation|Mean
2619337|NCT01965262|Primary|Visual Acuity - Hema-copolymer and Etafilcon A|Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline.|Baseline|All 30 subjects were dispensed lenses, and visual acuity measurements were obtained at baseline.|||logMAR||Standard Deviation|Mean
2619338|NCT01965158|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements With No Straining Per Week|"A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation.~The severity of straining with each bowel movement was assessed on the following scale: 0=no straining, 1=mild straining, 2=moderate straining, 3=severe straining, 4=very severe straining. SBMs without straining were defined as SBMs with a straining score of 0."|Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)|Intent-to-treat population|||SBMs with no straining / week||Standard Error|Least Squares Mean
2619339|NCT01965158|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Spontaneous Bowel Movements Per Week|A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. A complete spontaneous bowel movement (CSBM) was defined as an SBM which was accompanied by the feeling of complete evacuation.|Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)|Intent-to-treat population|||complete spontaneous BMs / week||Standard Error|Least Squares Mean
2619340|NCT01965158|Secondary|Change From Baseline to Week 1 in the Number of Spontaneous Bowel Movements Per Week|"A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of a rescue laxative therapy during the 24 hours prior to the BM.~Baseline was defined as the 14 days in the screening period prior to study drug administration."|Baseline and Week 1|Intent-to-treat population|||spontaneous bowel movements / week||Standard Error|Least Squares Mean
2619341|NCT01965158|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week|"A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of a rescue laxative therapy during the 24 hours prior to the BM.~Baseline was defined as the 14 days in the screening period prior to study drug administration."|Baseline and the last 2 weeks of the treatment period (Weeks 11 and 12 for participants who completed 12 weeks of treatment)|Intent-to-treat population|||spontaneous bowel movements / week||Standard Error|Least Squares Mean
2619342|NCT01965158|Primary|Percentage of Participants With a Spontaneous Bowel Movement (SBM) Response|"A bowel movement and constipation assessment (BMCA) was completed by participants every day during the screening and treatment periods to record information about bowel movements (BMs) and constipation. An SBM was defined as a bowel movement that occurred without the use of rescue laxative therapy during the 24 hours prior to the BM.~A responder was defined as a participant having 9 or more positive response weeks out of the 12-week Treatment Period and 3 positive response weeks out of last 4 weeks of the 12-week Treatment Period. A positive response week was defined as ≥ 3 SBMs per week and an increase from baseline of ≥ 1 SBM per week for that week. If a participant had less than 4 days of diary entries for a week, that week was treated as a non-response week.~Any participant with insufficient primary endpoint data (data for less than 9 out of 12 weeks of the Treatment Period or less than 3 out of the last 4 weeks of the 12-week Treatment Period) was treated as a non-responder."|12-week treatment period|Intent-to-treat population|||percentage of participants||95% Confidence Interval|Number
2619343|NCT01965067|Secondary|Heart Rate|From the start of administration of sugammadex to recovery of the TOF ratio to 0.7 or 0.8 in both groups, Heart rate at 1 min before reversal(pre-reversal), 1 min after reversal(post-reversal), recovery and 1 day after surgery (post-anesthetic visit).|1 min before reversal, 1 min after reversal, 1 day after surgery||||beats/min||Standard Deviation|Mean
2619344|NCT01965067|Secondary|Mean Arterial Blood Pressure|From the start of administration of sugammadex to recovery of the TOF ratio to 0.7 or 0.8 in both groups, mean arterial blood pressure at 1 min before reversal(pre-reversal), 1 min after reversal(post-reversal), recovery and 1 day after surgery (post-anesthetic visit).|1 min before reversal, 1 min after reversal, 1 day after surgery||||mmHg||Standard Deviation|Mean
2619345|NCT01965067|Other Pre-specified|Adverse Events|adverse effect of sugammadex(hypersensitivity, dry mouth, hypertension etc.)|During 7days after operation||||participants|||Number
2619346|NCT01965067|Other Pre-specified|Post-operative Nausea and Vomiting||During 7days after operation||||participants|||Number
2619347|NCT01965067|Other Pre-specified|Incidence of Residual Neuromuscular Blockade||During 1day after operation||||participants|||Number
2619348|NCT01965067|Primary|Reversal Time of Rocuronium|The time from the administration of sugammadex to recovery of the TOF ratio to 0.9 in deep neuromuscular block (1-2 twitches post-tetanic count) induced by rocuronium during mild hypothermia with core temperatures between 34.5°C and 35°C, and compared with the normal thermal condition.|The recovery time to the TOF ratio of 0.9 after the administration of the sugammadex, an expected average of 5 minutes||||seconds||Standard Deviation|Mean
2619349|NCT01965002|Secondary|Percent Successful Tumor Ablation|In the resected tumor specimen, the volume of the ablated area will be determined by obtaining a digital photograph of each pathology slice. The region of interest corresponding to the ablated area will be traced, and the ablated area will be calculated for each slice and summed. Accuracy is assessed as the percent ablated volume relative to pre-treatment tumor volume.|Up to 1 week|Due to the complexity of 3-dimensional mapping of tumors in soft tissues, the precision necessary to capture baseline tumor volume exceeded the capability of the equipment. Baseline data per protocol for the outcome calculation was only obtained from a single participant, resulting in an inability to conduct a robust per protocol analysis.|||percent ablated volume|||Number
2619350|NCT01965002|Secondary|Adverse Event Severity|"Safety is further assessed by an evaluation of severity for the treatment-related adverse events, reported as the number of adverse events for each of the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grades.~CTCAE Severity:~mild~moderate~severe~life-threatening~fatal"|6 months||||Treatment-related adverse events|||Number
2619351|NCT01965002|Primary|Overall Safety - Incidence of Any Device-related Adverse Events|Safety determined by evaluating for the incidence of any device-related adverse events. Patients will be assessed for pain and limb function, and by clinical examination before and after treatment to collect adverse events related to the treatment. Safety is reported as the total incidence of device-related adverse events.|1 week|All participants were evaluated for adverse events.|||device-related adverse events|||Number
2619352|NCT01964976|Secondary|Change From Baseline in Fasting Insulin Level|The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had fasting insulin data at baseline and post-baseline time points available.|||microunits per milliliter||Standard Deviation|Mean
2619353|NCT01964976|Secondary|Change From Baseline in Fasting Blood Glucose|The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the biguanide treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had fasting blood glucose data at baseline and post-baseline time points available.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2619354|NCT01964976|Secondary|Percentage of Participants of Achieving Objective Glycemic Control|The rate of achieving objective glycemic control in HbA1c level, was calculated at 12 month or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as <8.0%, <7.0%, and <6.0% of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.|Baseline and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
2619355|NCT01964976|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of biguanide treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2619356|NCT01964976|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who completed the study and had safety data available.|||participants|||Number
2619709|NCT01961167|Secondary|Change in Functional Status - EQ5D- Mobility|Change in functional status (EQ5D - Mobility) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.|30 days|Population includes subjects followed for at least 23 days and had relevant data.|||Participants|||Count of Participants
2619357|NCT01964976|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who completed the study and had safety data available.|||participants|||Number
2619358|NCT01964963|Secondary|Change From Baseline in Fasting Blood Glucose|The change in the value of fasting blood glucose level collected at final assessment point (up to Month 36) relative to baseline.|Baseline, and final assessment point (up to Month 36)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Milligram (mg)/ deciliter (dL)||Standard Deviation|Mean
2619359|NCT01964963|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final assessment point (up to Month 36) relative to baseline.|Baseline, and final assessment point (up to Month 36)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. The number analyzed is the number of participants with data available for analysis at the given time-point.|||Percent HbA1c||Standard Deviation|Mean
2619360|NCT01964963|Primary|Percentage of Participants Who Had One or More Adverse Events||Up to Month 36|Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.|||Percentage of Participants|||Number
2619361|NCT01964950|Secondary|Change From Baseline in Fasting Insulin Level|The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.|Months 1, 3, 6, 12, and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had fasting insulin data at baseline and post-baseline time points available.|||micro units per milliliter (mcU/mL)||Standard Deviation|Mean
2619362|NCT01964950|Secondary|Change From Baseline in Fasting Blood Glucose|The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the SU treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had fasting blood glucose data at baseline and post-baseline time points available.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2619363|NCT01964950|Secondary|Percentage of Participants Achieving Objective Glycemic Control|The rate of achieving objective glycemic control in HbA1c level was calculated at baseline and final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as <8.0%, <7.0%, and <6.0% of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.|Baseline and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of participants|||Number
2619364|NCT01964950|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)|The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2619365|NCT01964950|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reaction|Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + SU and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who completed the study and had safety data available.|||participants|||Number
2619366|NCT01964950|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + SU and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who completed the study and had safety data available.|||participants|||Number
2619367|NCT01964924|Other Pre-specified|Protein Intensity Fold-change Ratios Assessed by Reverse Phase Protein Assay Intensity Values|Ratios between tumors sampled prior to initiating trametinib single agent treatment and at time of progression (TOP) on either single agent trametinib or the combination (TOP/pre-treat ratio), will be calculated. These ratios will be median-centered and clustered using Cluster 2.0 software. Student's t-test for differences between average protein intensity ratios at these intervals will be calculated using Microsoft Excel by grouping all the ratios for individual clusters.|Up to 52 weeks|||||||
2619368|NCT01964924|Other Pre-specified|Predictive Value of PTEN and Other Biomarkers on Patient Outcome (Survival, ORR, and CBR)||At time of disease progression, assessed up to 52 weeks|||||||
2619369|NCT01964924|Secondary|Tolerability of the Regimen Defined as the Number of Patients Who Required Dose Modifications and/or Dose Delays||Up to 52 weeks||||Participants|||Count of Participants
2619370|NCT01964924|Secondary|Proportion of Patients Who Refuse Further Treatment for Lesser Toxicities That Inhibit Their Willingness to Continue Participation on the Trial||Up to 52 weeks|The proportion of patients who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial was in Part I|||Participants|||Count of Participants
2619371|NCT01964924|Secondary|Proportion of Patients Who go Off Treatment Due to Adverse Reactions|The proportion of patients who go off treatment due to adverse reactions or even those who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial was captured. These tolerability measures were assessed within each of the treatment parts independently. All patients who have received at least one dose of any of the therapeutic agents was evaluable for toxicity and tolerability.|Up to 52 weeks||||Participants|||Count of Participants
2619372|NCT01964924|Secondary|Progression-free Survival|The Kaplan-Meier method will be used to estimate progression-free survival distribution.|The duration of time from start of treatment to time of progression or death, whichever comes first, assessed up to 52 weeks||||weeks||95% Confidence Interval|Median
2619373|NCT01964924|Secondary|Overall Survival|The Kaplan-Meier method will be used to estimate overall survival distribution.|Start date of the treatment to the date of the event (i.e., death) or the date of last follow-up to evaluate that event, assessed up to 52 weeks|overall survival analyzed for all patients regardless of (part 1 only) or (part 1 and 2) participation|||weeks||95% Confidence Interval|Median
2619374|NCT01964924|Secondary|Incidence of Severe (Grade 3+) Adverse Events or Toxicities Graded Per NCI CTCAE Version 4.0|NCI CommonTerminology Criteria for Adverse Events (CTCAE) version 4.0 was utilized for grading incidence of toxicities (grade 3+).|Up to 52 weeks||||number of adverse events|||Number
2619375|NCT01964924|Secondary|Incidence of Adverse Events That Are Classified as Either Possibly, Probably, or Definitely Related to Study Treatment|Incidence of adverse events for patients that are classified as either possibly, probably, or definitely related to study treatment graded by National Cancer Institute (NCI) CTCAE v4.0|Up to 52 weeks||||number of adverse events|||Number
2619376|NCT01964924|Secondary|Duration of Objective Response|Summary statistics of duration of response for patients with objective response|up to 52 weeks||||days of response||Standard Deviation|Mean
2619377|NCT01964924|Secondary|Clinical Benefit Rate (CBR = CR+PR+Stable Disease [SD])|The clinical benefit rate (CR+PR+SD) will be reported for patients after Part 1 and after Part 2.|Up to 52 weeks||||Participants|||Count of Participants
2619378|NCT01964924|Primary|Objective Response Rate (ORR), Defined as the Proportion of Patients Who Have Had a Partial Response (PR) or Complete Response (CR) (RECIST 1.1 Based) Within the First 6 Months After Initiation of Therapy With Trametinib|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 months||||Participants|||Count of Participants
2619379|NCT01964898|Secondary|Negative Affect|As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.|Baseline to 6 months||||units on a scale||Standard Error|Mean
2619380|NCT01964898|Secondary|Positive Affect|As measured by the 10 item Positive Affect Negative Affect Scales (PANAS). The positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect in the past week. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance|Baseline to 6 months||||units on a scale||Standard Error|Mean
2619381|NCT01964898|Secondary|Depression: 10 Item Center for Epidemiologic Studies Depression Scale (CESD)|The 10 item Center for Epidemiologic Studies Depression Scale ranges from 0-30 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.|Baseline to 6 months||||units on a scale||Standard Error|Mean
2619382|NCT01964898|Secondary|Depression: 9 Item Patient Health Questionnaire (PHQ-9)|The 9 item Patient Health Questionnaire (PHQ-9) ranges from 0-27 with higher scores indicating higher depression symptoms. Adjusted for anti-depressant medication use and for cardiac rehabilitation attendance.|Baseline to 6 months||||units on a scale||Standard Error|Mean
2619383|NCT01964898|Primary|Time to Smoking Lapse|Time in days to first lapse (i.e., first puff of a cigarette) after discharge, which were determined through timeline follow back interviewing. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.|6 months||||Days||Standard Error|Mean
2619384|NCT01964898|Primary|Time to Smoking Relapse|Time in days to first relapse (i.e., smoking on 7 consecutive days or smoking in 2 consecutive 7 day periods), which were determined through timeline follow back interviewing. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.|6 months||||Days||Standard Error|Mean
2619385|NCT01964898|Primary|Continuous Abstinence From Smoking Since Discharge|Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.|6 months||||proportion of participants||95% Confidence Interval|Number
2619386|NCT01964898|Primary|Smoking Cessation: 7 Day Point Prevalence Abstinence|No smoking, not even a puff, for 7 days; verified by carbon monoxide measurement. Results are adjusted for nicotine patch use and concurrent medication treatment targeting cessation.|6 months||||proportion of participants||95% Confidence Interval|Number
2619387|NCT01964755|Secondary|Measurement of Immune Activation Markers and Inflammation in Peripheral Blood|Measurement of immune activation markers and inflammation in peripheral blood in response to treatment and EBV reactivation.|Through Duration of Response to Protocol Therapy Until Disease Progression, Up to 5 years|This outcome measure was added via amendment for new participants enrolled after December 2016 however; no new participants were enrolled. No data were collected for this outcome measure.||||||
2619388|NCT01964755|Secondary|Baseline Tumor EBV Gene Expression Profile in Study Participants|Determine baseline tumor EBV gene expression profile to assess viral thymidine kinases. (BXLF1/vTK and BGLF4/PK), EBV latency pattern (I, II or III) and lytic phase.|Baseline|This outcome measure was added via amendment for new participants enrolled after December 2016 however; no new participants were enrolled. No data were collected for this outcome measure.||||||
2619389|NCT01964755|Secondary|EBV Reactivation in Circulating Peripheral Blood Memory B-cells Before and After Protocol Therapy.|Measurement of EBV reactivation in circulating peripheral blood memory B-cells before and after treatment with chemotherapy/Zidovudine (ZDV) in order to assess the drug effect on EBV latency.|From Baseline Up to 1 year Post-Therapy|This outcome measure was added via amendment for new participants enrolled after December 2016 however; no new participants were enrolled. No data were collected for this outcome measure.||||||
2619390|NCT01964755|Secondary|EBV Viral Load in Peripheral Blood Before, During and After Protocol Therapy|Measurement of Epstein Barr Virus (EBV) viral load in peripheral blood in study participants before, after treatment, and during surveillance in order to correlate the presence of with tumor load and disease status.|From Baseline Up to 1 year Post-Therapy|Serum EBV viral load levels were below the limit of detection in subjects before therapy. Data were not collected during and after therapy.||||||
2619391|NCT01964755|Secondary|T-Cell Subset Levels in Peripheral Blood in Positive Participants Before, During and After Protocol Therapy|Measurement of T-cell subset levels (CD4, CD8) in peripheral blood before, during and after protocol therapy to assess the effect of protocol therapy on immune re-constitution or exhaustion.|From Baseline Up to 1 Year Post-Therapy|Per protocol, evaluable participants are those who receive 3 or more cycles of treatment. Three of these participants were HIV-positive. Data for T-cell subset levels (CD4, CD8) were available during and after for two of these three participants.|||cells/mm^3||Standard Deviation|Mean
2619392|NCT01964755|Secondary|HIV Viral Load in Positive Subjects Before, During and After Protocol Therapy|Measurement of HIV Viral Load in positive subjects before, during and after protocol therapy to assess the effect of protocol therapy on immune reconstitution or exhaustion.|From Baseline Up to 1 Year Post-Therapy|Per protocol, evaluable participants are those who receive 3 or more cycles of treatment. Three of these participants were HIV-positive. Before therapy, HIV viral load was undetectable in 2 participants.|||copies/ml|||Number
2619393|NCT01964755|Secondary|Rate of Toxicity Related to Protocol Therapy|Rate of adverse events, serious adverse events or other toxicities related to protocol therapy in study participants.|Through Duration of Protocol Therapy, Up to six 21-day cycles (+/- 7 days)|Participants starting at least once cycle of protocol therapy. Participants experiencing toxicity are tabulated by grade (gr.) of toxicity.|||Participants|||Count of Participants
2619394|NCT01964755|Secondary|One-Year Rate of Failure-Free Survival (FFS)|Rate of failure-free survival of study participants one-year after start of protocol therapy. Failure-free survival (FFS) will be measured from the date of treatment initiation until date of documented disease progression, relapse after response, or death from any cause. For patients alive and free of relapse or progression, follow-up time will be censored at the last documented date of failure-free status. Kaplan-Meier estimate of failure-free survival at one-year.|12 months|Participants receiving at least one cycle of protocol therapy.|||percentage of participants||95% Confidence Interval|Number
2619395|NCT01964755|Secondary|One-year Rate of Overall Survival|Rate of overall survival of study participants at one year since initiation of protocol therapy. Overall survival (OS) will be measured from the date of initiation of study treatment until date of death from any cause. In the absence of death, the follow-up will be censored at date of last contact (censored observation). Kaplan-Meier estimate of overall survival at one-year.|12 months|Participants receiving at least one cycle of protocol therapy.|||percentage of participants||95% Confidence Interval|Number
2619396|NCT01964755|Primary|Rate of Complete Response to Protocol Therapy|"Complete Response (CR) rate in study participants to protocol therapy. Response will be assessed via CT Scan and bone marrow aspirate/biopsy, if applicable. Complete response criteria include:~Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to Non Hodgkin's Lymphoma (NHL);~All lymph nodes and tumor masses disappeared or regressed to normal size (≤ 1.5 cm in their greatest transverse diameters for nodes > 1.5 cm before therapy);~Previously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter (GTD) before treatment must have decreased to ≤ 1 cm in their GTD after treatment, or by more than 75% bin the sum of the products of the greatest diameters (SPD);~No new sites of disease."|About 21 days|Participants who started at least one cycle of protocol therapy.|||Participants|||Count of Participants
2619397|NCT01964716|Secondary|Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series|"Antibody geometric mean titers as measured by OPA assay for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMTs were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the titers. Here n= participants evaluable =specified category."|1 month after the infant series|Evaluable immunogenicity population:participants who received vaccine (randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. OPA analysis was performed in a subset of randomly selected participants from each group.|||titer||95% Confidence Interval|Geometric Mean
2619398|NCT01964716|Secondary|Percentage of Participants Achieving a Serotype-Specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit of Quantitation (LLOQ) 1 Month After Infant Series|"Percentage of participants achieving OPA Titer >= lower limit of quantitation (LLOQ) along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. The LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43, Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; and Pn23F, 13. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here n= Number of participants with an antibody titer ≥ LLOQ for the given serotype."|1 month after the infant series|Evaluable immunogenicity population:participants who received vaccine (randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations. OPA analysis was performed in a subset of randomly selected participants from each group.|||percentage of participants||95% Confidence Interval|Number
2619705|NCT01961167|Secondary|Change in Functional Status - EQ5D - Usual Activities|Change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.|30 days|Population includes subjects followed for at least 23 days and had relevant data.|||Participants|||Count of Participants
2619399|NCT01964716|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Dose 1|An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Adverse events were also reported in participants who provided consent but were not randomized in this study. The data of these participants has been reported under 'Screened Only' arm.|Informed consent up to Dose 1|Safety population: participants who received at least 1 dose of study vaccine. Here “N”= participants evaluable for this outcome measure.|||participants|||Number
2619400|NCT01964716|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in the Infant Series|An AE was any untoward medical occurrence in a participants who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 to 42 days after last dose that were absent before treatment or that worsened relative to pretreatment state|Dose 1 up to 28 to 42 days after dose 3|Safety population included all participants who received at least 1 dose of study vaccine.|||participants|||Number
2619401|NCT01964716|Primary|Number of Participants Reporting Systemic Events Within 5 Days After Dose 3 in MDV and SDS Group|Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 5 days after Dose 3 (Day 2 to Day 6) of infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days. ‘n’ included participants whose response was “Yes” for any day or “No” for all days for specified systemic event.|||participants|||Number
2619402|NCT01964716|Primary|Number of Participants Reporting Systemic Events Within 5 Days After Dose 2 in MDV and SDS Group|Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 5 days after Dose 2 (Day 2 to Day 6) of infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days. ‘n’ included participants whose response was “Yes” for any day or “No” for all days for specified systemic event.|||participants|||Number
2619403|NCT01964716|Primary|Number of Participants Reporting Systemic Events Within 5 Days After Dose 1 in MDV and SDS Group|Systemic events (any fever greater than or equal to [>=] 38.0 degrees Celsius [C], decreased appetite was scaled as; Moderate (decreased oral intake); Severe (refusal to feed). Irritability scaled as; Mild (easily consolable); Moderate (requiring increased attention); Severe (Inconsolable, crying that cannot be comforted). Increased sleep was scale as; mild (increased or prolonged sleeping bouts); Moderate (slightly subdued interfering with daily activity); Severe (Disabling not interested in usual daily activity) and use of antipyretic medication were reported using an electronic diary. Participants may be represented in more than 1 category.|Within 5 days after Dose 1 (Day 2 to Day 6) of infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days. ‘n’ included participants whose response was “Yes” for any day or “No” for all days for specified systemic event.|||participants|||Number
2619404|NCT01964716|Primary|Number of Participants Reporting Local Reaction Within 5 Days After Dose 3 in MDV and SDS Group|Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.|Within 5 days after Dose 3 (Day 2 to Day 6) of the infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days.|||participants|||Number
2619405|NCT01964716|Primary|Number of Participants Reporting Local Reaction Within 5 Days After Dose 2 in MDV and SDS Group|Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.|Within 5 days after Dose 2 (Day 2 to Day 6) of the infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days and 'n' = participants whose response was “Yes” for any day or “No” for all days for specified local reaction.|||participants|||Number
2619569|NCT01962675|Secondary|Change From Baseline Score on Toe Tap Test|Measuring the Time required to perform toe taps|Two times, 1) Baseline, and 2) Up to 1 hour after intervention.|Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.||||||
2619406|NCT01964716|Primary|Number of Participants Reporting Local Reaction Within 5 Days After Dose 1 in MDV and SDS Group|Local reactions were reported within 5 days (day 2 to day 6) using an electronic diary. Tenderness was scaled as Any (tenderness present); Mild (hurt if gently touched; Moderate (hurt if gently touched with crying); Severe (caused limitation of limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.1 to 7.0 cm); Severe (greater than [>] 7.0 cm). Participants may be represented in more than 1 category.|Within 5 days after Dose 1(Day 2 to Day 6) of the infant series|Safety population included participants who received at least 1 dose of study vaccine. ‘N’ (number of participants analyzed) included participants whose response was “Yes” for any day or “No” for all days.|||participants|||Number
2619407|NCT01964716|Primary|Geometric Mean Concentration (GMC) for Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series for Each Vaccine Group|"Antibody GMC for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. CIs were back transformations of a confidence interval based on the Student t distribution for the mean logarithm of the concentrations. Here n= participants with valid and determinate IgG concentration to the given serotype."|1 month after the infant series|Evaluable immunogenicity population: eligible participants who received vaccine (as randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations.|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
2619408|NCT01964716|Primary|Percentage of Participants Achieving a Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal To (>=) 0.35 Microgram Per Milliliter (mcg/mL) 1 Month After the Infant Series for Each Vaccine Group|"Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided confidence interval (Clopper and Pearson) based on the observed proportion of participants. Here n= participants with valid and determinate IgG concentration to the given serotype."|1 month after the infant series|Evaluable immunogenicity population: eligible participants who received vaccine (as randomized) at all 3 doses, had blood drawn within protocol-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2619409|NCT01964547|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of subjects who experienced an adverse event during the course of the study is presented.|0-50 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||participants|||Number
2619410|NCT01964547|Secondary|Change From Baseline to End of Treatment in Timed 10-meter Walk Times.|Only those patients for whom it was appropriate (i.e. ambulatory patients) were timed for how long it took to walk 10 metres. If a patient started the 10-meter walk but was unable to complete it, an estimated time for completion was calculated based on the available data. A negative difference from baseline indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||seconds||Standard Deviation|Mean
2619411|NCT01964547|Secondary|The Number of Patients With a Treatment-emergent Flag Using the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Course of the Study.|"Patients were scored at each clinic visit for the following outcomes using the C-SSRS: suicidal ideation, suicidal behaviour, suicidality (including complete suicidality). Possible flags were as follows: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation Without Intent, Active Suicidal Ideation With Intent, No Plan, Active Suicidal Ideation With Intent and Plan. The number of patients with a treatment-emergent flag is presented."|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||participants|||Number
2619412|NCT01964547|Secondary|Change From Baseline to End of Treatment in Number of Visits to a Healthcare Professional.|At baseline, patients were asked how many times they had visited a healthcare professional in the previous 12 weeks. At subsequent visits, patients were asked how many times they had visited a healthcare professional since their last study visit. The change from baseline to the end of treatment is presented. A decrease in number indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||visits||Standard Deviation|Mean
2619413|NCT01964547|Secondary|Change From Baseline to End of Treatment in Modified Ashworth Scale Total Score.|All 20 muscle groups were assessed for spasticity (using a 0-5 scale): 0= 'no increase in muscle tone' to 5= 'affected part(s) rigid in flexion or extension'. The score for all 20 muscle groups were added to give a total score out of 100. A decrease in score indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2619414|NCT01964547|Secondary|Physician's Global Impression of Change (PGIC) in the Severity of the Patient's Spasticity at the End of Treatment.|"Physicians were asked the following question to be rated on a seven-point scale:~How has the subject's spasticity changed since Visit 1? The markers were: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better.~The number of patients for each of the markers is presented at the final study visit."|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||participants|||Number
2619415|NCT01964547|Secondary|Caregiver's Global Impression of Change (CGIC) in the Severity of the Patient's Spasticity at the End of Treatment.|"Caregivers were asked the following question to be rated on a seven-point scale:~How has the subject's spasticity changed since Visit 1? The markers were: Very much worse, Much worse, Minimally worse, No change, Minimally better, Much better, Very much better.~The number of patients for each of the markers is presented at the final study visit."|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||participants|||Number
2619416|NCT01964547|Secondary|Subject Global Impression of Change (SGIC) in the Severity of Their Spasticity at the End of Treatment.|"Patients were asked the following question, to be rated on a seven-point scale:~Please assess the change in your spasticity since immediately before receiving the first dose of study treatment (Visit 1) using the scale below.~The markers were: 'Very much worse', 'Much worse', 'Minimally worse', 'No change', 'Minimally better', 'Much better' or 'Very much better'.~The number of patients for each of the markers is presented at the final study visit."|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||participants|||Number
2619417|NCT01964547|Secondary|Change From Baseline to the End of Treatment in Beck Depression Inventory-II (BDI-II) Total Score.|The BDI-II is a multiple choice self-reported inventory that is one of the most widely used instruments for measuring the severity of depression. There are 21 questions or items, each having four possible responses. Each response is assigned a score ranging from zero to three, indicating the severity of the symptom. Items 1 to 13 assess symptoms that are psychological in nature, while items 14 to 21 assess symptoms that are more physical. The sum of all BDI-II item scores indicates the severity of depression. For patients eligible for this study, a score of 21 or over represents depression. The BDI-II can distinguish between different subtypes of depressive disorders, such as major depression and dysthymia. A reduction in score indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2619418|NCT01964547|Primary|Change From Baseline to the End of Treatment in Paced Auditory Serial Addition Test (PASAT) Total Score.|The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Stimulus presentation rates were adapted for use with multiple sclerosis patients. The PASAT is presented on audio compact disk to control the rate of stimulus presentation. Single digits are presented either every 3 seconds (PASAT 1) or every 2 seconds (PASAT 2), and the patient must add each new digit to the one immediately prior to it. The test score is the sum of the total number of correct sums given (out of 60 possible) in each trial. An increase in score indicates an improvement in condition.|0-48 weeks|All randomized patients who received at least one dose of study medication and yielded on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2619419|NCT01964521|Secondary|Levels of Pain in Connection to Dressing Changes.|Levels of pain measured by VAS, visual analog scale. 1 to 100 mm, 1= low pain, 100= worse pain.|4 weeks|For some patients pain assessment was not performed at all predefined timepoints. Therefore some data were not collected.|||units on a scale||Standard Deviation|Mean
2619420|NCT01964521|Primary|Changes in Signs and Symptoms of Local Infection|Evaluation of signs of infection (exudate) from baseline|4 weeks|ITT|||Participants|||Count of Participants
2619421|NCT01964430|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE's)|"TEAEs are defined as any adverse event (AE) that begin or worsen on or after the start of study drug or procedure of the study period through the maximum duration of the period plus 28 days. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death. Relation to study drug was determined by the investigator. A treatment-related TEAE is defined as TEAE which was considered to be related to one or both of the study drugs and reported as 'Suspected' on the case report form. AEs with a missing relationship were treated as 'treatment-related' in data summaries. IP (investigational product) refers to nab-Paclitaxel and/or Gemcitabine. Related TEAE refers to relation to study drug (IP)."|From day 1 of study drug up to 28 days after the last dose of study drug; up to the data cut off date of 31 December 2018. up to 57 months.|Treated Population consisted of randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2619422|NCT01964430|Secondary|Kaplan Meier Estimate of Overall Survival (OS)|Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the end of study or clinical data cut were censored on the last-known-to-be-alive date or the clinical cutoff date, whichever was earlier.|From randomization date up to data cut off date of 31 Dec 2018; median OS follow-up time for censored participants was 38.702 months for nab-Paclitaxel and gemcitabine and 37.979 months for gemcitabine alone|The intent-to-treat population consisted of all randomized participants regardless of whether the participant received any IP or had any efficacy assessment collected.|||months||95% Confidence Interval|Median
2619423|NCT01964430|Primary|Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee|Disease free survival was defined as the time from the date of randomization to the date of disease recurrence or death, whichever occurred earlier. Disease recurrence was determined by the independent radiological review of computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants who did not have disease recurrence or did not die were censored at the last tumor assessment date with disease-free status or the randomization date if the last tumor assessment with disease-free status was missing. Disease-free status referred to a status that was neither being disease recurrent nor indeterminate or not evaluable. Participants who received new anti-cancer therapy or cancer-related surgery prior to disease recurrence or death were censored at the date of last tumor assessment with disease-free status prior to the start of new anti-cancer therapy or cancer-related surgery or the randomization date.|Date of randomization up to data cut off date of 31 December 2018; median DFS follow-up time for censored participants was 22.242 months for nab-Paclitaxel and gemcitabine and 13.832 months for gemcitabine alone|The intent-to-treat population consisted of all randomized participants regardless of whether they received any investigational product (IP) or had any efficacy assessment collected.|||months||95% Confidence Interval|Median
2619470|NCT01963611|Secondary|Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan|Change from baseline in volume of T1 Gd-enhancing lesions per subject was calculated using 5 Serial MRI Scans.|Baseline, Weeks 12, 24, 28, 32, 36, 40|ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.|||cubic millimeter (mm^3)||Standard Deviation|Mean
2619424|NCT01964378|Other Pre-specified|Change From Baseline to End-of-Treatment Visit in Chronic Pain Sleep Inventory (CPSI) Scores|The CPSI measures 5 items on 100-mm visual analog scales: trouble falling asleep (CPSI1), needing sleep medication (CPSI2), awakened by pain during the night (CPSI3) and in the morning (CPSI4) [all with anchors for 0 = never and 100 = always], and overall quality of sleep (CPSI5) [with anchors of 0 = very poor and 100 = excellent]. The sleep problem index is the sum of items CPSI1, CPSI3 and CPSI4. The minimum sleep problem index is 0 mm, the maximum 300 mm, the higher the worse. For the overall quality of sleep, minimum and maximum are 0 and 100 mm, the higher the better. A decrease in the sleep problem index indicates an improvement as does an increase in the overall quality of sleep. Changes from baseline to the End-of-Treatment Visit of the Maintenance Phase (scheduled for Week 6) were calculated.|Baseline; End-of-Treatment Visit (6 weeks)|Full Analysis Set|||units on a scale||Standard Deviation|Mean
2619425|NCT01964378|Other Pre-specified|Change in Weekly Mean of the Daily Worst Pain Intensity Score From Baseline|"Participants will be asked: Please rate your pain by selecting the one number that best describes your pain at its worst during the last 24 hours. every day in the morning. They will score their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The weekly mean value of the 24 h worst pain intensity will be calculated as a mean score of these daily entries of worst pain intensity for each trial week. A positive change from baseline will indicate a worsening, whilst a negative change will indicate an improvement of pain."|Baseline; End-of-Treatment Visit (6 weeks)|Full analysis set (FAS)|||units on a scale||Standard Deviation|Mean
2619426|NCT01964378|Other Pre-specified|Overall Score of the Patient Assessment of Constipation Symptoms (PAC-SYM)|The PAC-SYM is a 12-item self-administered questionnaire that assesses the severity of constipation-related symptoms during past 2 weeks. Items are rated on a 5-point Likert scale, where 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.The PAC-SYM contains 3 subscales: stool symptoms (5 items), abdominal symptoms (4 items), rectal symptoms (3 items). If at least 6 items are assessed, the PAC-SYM overall score is calculated as the sum of the scores of all non-missing items divided by number of non-missing items. The minimum overall score is 0, the maximum overall score is 4. If more than 6 items are missing, no overall score is calculated. Changes from baseline for the overall score are presented. If the changes in the overall (or subscale) scores are positive then there is a worsening in symptoms associated with constipation.|Baseline; End-of-Treatment Visit (6 weeks)|Safety Set; number of participants with data available.|||units on a scale||Standard Deviation|Mean
2619427|NCT01964378|Other Pre-specified|Clinical Global Impression of Change (CGIC)|In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change in patient's condition over the treatment period as compared to patient's condition prior to the start of treatment. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End-of-Treatment Visit (6 weeks)|Full Analysis Set (FAS). End of Treatment (End of Maintenance Period Visit). Participants with data available.|||Participants|||Count of Participants
2619428|NCT01964378|Other Pre-specified|Patient Global Impression of Change (PGIC)|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period compared to his condition prior to the start of treatment. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Baseline; End-of-Treatment Visit (6 weeks)|Full Analysis Set (FAS). End of Treatment (End of Maintenance Period Visit). Participants with data available.|||Participants|||Count of Participants
2619429|NCT01964378|Other Pre-specified|Change in the Physical and Mental Component Scores From the Short Form 12® Health Survey (SF-12)|"The Physical and Mental Component Scores are calculated from the responses by participants to 12 questions. These 12 questions cover 8 domains, (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role participation with emotional health problems, and mental health) that a participant was asked to rate over the last week. Questions are scored on a Likert-scale.~The Physical and Mental Component Scores were not derived as the trial was terminated.~Changes in the individual item scores are therefore reported. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.~If the values are positive there was an improvement. The higher the value the greater the improvement."|Baseline; End-of-Treatment Visit (6 weeks)|Full Analysis Set (FAS). End of Treatment (End of Maintenance Period Visit).|||units on a scale||Standard Deviation|Mean
2619430|NCT01964378|Other Pre-specified|EuroQol-5 Dimension (EQ-5D) Health Questionnaire: Visual Analog Scale (VAS) Score|The EuroQol-5 Dimension Health Questionnaire is a generic health related quality of life instrument. EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.|Baseline; End-of-Treatment Visit (6 weeks)|Full Analysis Set; means (standard deviations) are presented for the number of participants at the End-of-Treatment Visit with respective data available.|||units on a scale||Standard Deviation|Mean
2619431|NCT01964378|Other Pre-specified|EuroQol-5 Dimension (EQ-5D) Health Questionnaire: Weighted EQ-5D Health Status Index|"The EuroQol-5 Dimension Health Questionnaire is a generic health related quality of life instrument. The participants will answer 5 questions on 5 dimensions of their health related quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each question has 3 possible answers reflecting 3 levels of impact on the quality of life. The weighted EQ-5D health status index values are derived and reported as change from baseline. The responses to the 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group.~A positive change indicates an improvement."|Baseline; End-of-Treatment Visit (6 weeks)|Full Analysis Set; means (standard deviations) are presented for the number of participants at the End-of-Treatment Visit with respective data available.|||units on a scale||Standard Deviation|Mean
2619774|NCT01960790|Secondary|Changes in C-reactive Protein (CRP)|The change in CRP from baseline through the end of the study was assessed.|Up to Week 156|All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy.|||mg/dL||Standard Deviation|Mean
2619432|NCT01964378|Other Pre-specified|Overall Score of the Neuropathic Pain Symptom Inventory (NPSI)|"Participants with neuropathic pain (determined by the completion of the Douleur Neuropathique En 4 Questions [DN4] questionnaire at allocation) rated their symptoms of neuropathic pain on the Neuropathic Pain Symptom Inventory (NPSI). Ten out of 12 questions were answered on an 11-point scale 0 (no symptom present) to 10 (worst imaginable); 2 out of 12 questions assessed the duration of spontaneous pain and the number of pain attacks and were answered by selecting 1 of 5 possible responses.~Mean scores of NPSI were calculated. The overall NPSI score was calculated by the summation of all responses in the ranges between 0 (all symptoms absent) and 1 (all symptoms present and at the worst intensity). A negative change indicates that the intensity of all the neuropathic symptom components have decreased since the start of treatment."|Baseline; End-of-Treatment Visit (Week 6)|Subset of participants that were assessed to have Neuropathic Pain (using the DN4 questionnaire) at baseline.|||units on a scale||Standard Deviation|Mean
2619433|NCT01964378|Other Pre-specified|Response Rate to Treatment|Pain intensity will be recorded daily by each participant in the morning on an 11-point Numerical Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain). From this, the weekly average 24-hour pain intensity will be calculated. The number of participants with a 0, 10, 20, 30, up to a 100% reduction in weekly mean pain intensity will be reported over each week and over the last 2 weeks of the maintenance period.|Baseline; last 2 weeks of the expected 6-week treatment period|Full Analysis Set (FAS). Worsening in 24-hour pain or premature discontinuation due to lack of efficacy or Adverse Event was regarded a non-response, other missing data is imputed using last observation carried forward (LOCF).|||Participants|||Count of Participants
2619434|NCT01964378|Other Pre-specified|Change in Weekly Mean of the Daily Average Pain Intensity Score From Baseline|"Participants will be asked: Please rate your pain by selecting the one number that best describes your pain on average during the last 24 hours. every day in the morning. They will score their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The weekly mean value of the 24-h average pain intensity will be calculated as a mean score of these daily entries of average pain intensity for each trial week."|Baseline; last 2 weeks of the expected 6-week treatment period|Full Analysis Set (FAS)|||units on a scale||Standard Deviation|Mean
2619435|NCT01964378|Secondary|Proportion of Participants With Clinically Relevant Pain Reduction at the End of the Maintenance Period|"Each participant indicated the level of pain on an 11-point numerical rating scale (NRS), where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The participants entered their pain intensity in their diary on a daily basis. The pain intensity score in the 2 weeks prior to the final evaluation in the maintenance period was compared with the baseline, the baseline pain intensity was calculated based on the 3 days prior to treatment allocation.~The definition of a clinically relevant pain reduction (yes/no) was the presence of at least 1 of the 3 following conditions:~Average pain intensity (i.e., average of the 24-hour pain intensities over the last 2 weeks of the Maintenance Phase) of less than 4 points on the 11-point NRS, or~Reduction in average pain intensity by at least 30% (compared to the baseline assessment), or~Reduction in average pain intensity by at least 2 points (compared to the baseline assessment)."|The last 2 weeks of the expected 6-week treatment period.|Full Analysis Set (FAS). Clinically relevant pain reduction (Yes/No) in Maintenance Week 3 and Week 4. Missing data were imputed using a multiple imputation on the weekly average pain intensity. Participants that discontinued from the trial due to a lack of efficacy were classified as non-responders.|||Participants|||Count of Participants
2619436|NCT01964378|Primary|Average Amount of Daily Rescue Medication at the End of the Maintenance Period (Full Analysis Set)|Morphine sulfate IR 10 mg tablets were supplied as rescue medication to trial participants. No dose adjustments of the morphine prolonged release or cebranopadol were allowed during the maintenance period. The daily use of morphine sulfate 10 mg IR tablets was documented by each participant in the trial. The total daily amount of morphine IR was subject to an upper limit recommendation. The primary endpoint is the average amount of daily rescue medication intake over the last 2 weeks of the maintenance period.|The last 2 weeks of the expected 6-week treatment period.|The Full Analysis Set includes all allocated participants who took at least 1 dose of the investigational medicinal product (IMP) and had at least 1 day with information for the amount of rescue medication intake after the first intake of double-blind IMP (study drug).|||milligram(s)/24 hours||Standard Error|Least Squares Mean
2619437|NCT01964378|Primary|Average Amount of Daily Rescue Medication at the End of the Maintenance Period (Per Protocol Set)|Morphine sulfate immediate release (IR) 10 mg tablets were supplied as rescue medication to trial participants. No dose adjustments of the morphine prolonged release or cebranopadol were allowed during the maintenance period. The daily use of morphine sulfate 10 mg IR tablets was documented by each participant in the trial. The total daily amount of morphine IR was subject to an upper limit recommendation. The primary endpoint is the average amount of daily rescue medication intake over the last 2 weeks of the maintenance period.|The last 2 weeks of the expected 6-week treatment period.|The Per Protocol Set (PPS) describes a subset of subjects in the Full Analysis Set (FAS). The PPS included all allocated participants who completed at least 2 weeks of treatment in the maintenance phase and had no major protocol deviations relevant for efficacy evaluations.|||milligram(s)/24 hours||Standard Error|Least Squares Mean
2619438|NCT01964352|Secondary|FVC AUC0-3h Response (Change From Baseline)|The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS|||L||Standard Error|Mean
2619455|NCT01964222|Secondary|Self-efficacy for Communicating About Cancer Clinical Trials|A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include an item in which participants rank their self-efficacy for finding information about cancer clinical trials on a 5-point scale with higher numbers indicating greater self-efficacy. Participation in study concludes upon completion of questionnaire.|1 day (Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of participant-reported self-efficacy for finding information about cancer clinical trials.|||units on a scale of 1 to 5||Standard Deviation|Mean
2619439|NCT01964352|Secondary|TDI Focal Score|"This endpoint was evaluated based on the data from this individual trial and also based on the data from the combined dataset from this trial and the replicate study NCT02006732. The results for the combined dataset are included in the disclosure for NCT02006732 as specified in the analysis plan. Mahler Transitional Dyspnoea Index (TDI) focal score was performed to measure the effect of the treatment on patients' dyspnoea.(Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9).~The adjusted mean (SE) are obtained from fitting an MMRM model including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks|Patients from FAS|||Units on a scale||Standard Error|Mean
2619440|NCT01964352|Secondary|Trough Forced Vital Capacity (FVC) Response (Change From Baseline)|Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FVC measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FVC response was defined as trough FVC minus baseline FVC. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS|||L||Standard Error|Mean
2619441|NCT01964352|Primary|St. George's Respiratory Questionnaire (SGRQ) Total Score|"This endpoint was evaluated based on the data from this individual trial and also based on the data from the combined dataset from this trial and the replicate study NCT02006732. The results for the combined dataset are included in the disclosure for NCT02006732 as specified in the analysis plan. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom."|12 weeks treatment|Patients from FAS|||units on a scale||Standard Error|Mean
2619442|NCT01964352|Primary|Trough FEV1 Response (Change From Baseline)|Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours). It was calculated as the mean of the 2 FEV1 measurements performed 23 h and at 23 h 50 min after inhalation of study medication at day 85. Trough FEV1 response was defines as trough FEV1 minus baseline FEV1. The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from FAS|||L||Standard Error|Mean
2619443|NCT01964352|Primary|FEV1 AUC0-3h Response|Forced expiratory volume in one second (FEV1) Area under the curve (AUC) 0-3h was calculated as the area under the FEV1-time curve from 0 to 3h post-dose using the trapezoidal rule, divided by the duration (3h) to report in litres. FEV1 AUC0-3h response was defined as FEV1 AUC0-3h minus baseline FEV1. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment by test day interaction, baseline, and baseline by test day interaction; patient as a random effect; spatial power covariance structure for within−patient errors and Kenward−Roger approximation of denominator degrees of freedom.|baseline and 12 weeks|Patients from the Full Analysis Set (FAS): This patient set included all randomized and treated patients who had a baseline and at least one postbaseline measurement for any of the primary efficacy endpoints. The patient that entered the study with two different patient numbers was excluded from the FAS.|||L||Standard Error|Mean
2619444|NCT01964326|Secondary|"Percentage of Participants Who Stopped Study Medication Use and Asked a Doctor if They Experienced Any of the Labeled Stop Use and Ask a Doctor Symptoms"|"Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The Stop use and ask a doctor symptoms included: (a) unexplained muscle pain or weakness or tenderness, (b) unusual fatigue, (c) loss of appetite (d) upper belly pain (e) dark-colored urine or (f) yellowing of the whites of eyes or skin. The behavior of the participants was considered correct if participants stopped use and contacted a doctor within 7 days after the event (symptom development).The behavior was considered acceptable if participants either stopped use or contacted a doctor (but did not do both) within the 7 days' timeframe."|Day 1 up to Week 26|"The analysis was performed on the participants from the user set who experienced any of the labeled Stop use and ask a doctor symptoms."|||Percentage of participants||95% Confidence Interval|Number
2619445|NCT01964326|Secondary|"Percentage of Participants Taking an Ask a Doctor or Pharmacist Before Use Medication Who Followed the Labeling and Contacted a Doctor or Pharmacist Before Using Study Medication"|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. 'Ask a doctor or pharmacist before use' medication included human immunodeficiency virus (HIV) medicine, digoxin, telaprevir, rifampin, colchicine, or oral contraceptives. The behavior of the participants was considered correct if participants asked a doctor or pharmacist before use. The behavior was considered acceptable if participants contacted a doctor or pharmacist within 7 days of initiating therapy.|Day 1 up to Week 26|"The analysis was performed on the participants from the user set who reported the use of any Ask a doctor or pharmacist before use medication."|||Percentage of participants||95% Confidence Interval|Number
2619469|NCT01963611|Secondary|Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan|Change from baseline per subjects in volume of T2 Gd-enhancing lesions was calculated using 5 series MRI scan.|Baseline, Weeks 12, 24, 28, 32, 36, 40|ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.|||cubic millimeter (mm^3)||Standard Deviation|Mean
2619706|NCT01961167|Secondary|Change in Functional Status - EQ5D - Self Care|Change in functional status (EQ5D - Self Care) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.|6 Months|Population includes subjects followed for at least 150 days and had relevant data.|||Participants|||Count of Participants
2619446|NCT01964326|Primary|Percentage of Participants Who Took Appropriate Action Based on Their LDL-C Results|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants self-reported an LDL-C level below 130 milligram per deciliter (mg/dL) or normal, or low and decided to continue with atorvastatin OTC or if participants self-reported an LDL-C below 130 mg/dL, or normal, or low but stopped the use because of new conditions preventing them from continuing use. The behavior was considered acceptable if participants self-report LDL-C level between 130 and 135 mg/dL and continued to use atorvastatin OTC without contacting a physician or other health care practitioner or if participants self-reported LDL-C greater than or equal to (>=) 130 mg/dL('borderline high' or 'high' LDL-C), and contacted a physician after getting the LDL-C test results.|Day 1 up to Week 26|The analysis was performed on continuing users who checked their LDL-C during the study.|||Percentage of participants||95% Confidence Interval|Number
2619447|NCT01964326|Primary|Percentage of Participants Who Complied With the Direction to Check Their Low-density Lipoprotein Cholesterol (LDL-C) Level|Percentage of participants whose behavior was either correct or acceptable were considered to be compliant. The behavior was considered correct if participants had their LDL-C checked between Weeks 4 and 12. The behavior was considered acceptable if participants had their LDL-C checked between Weeks 2 and 3 (before Week 4) or between Weeks 13 (after Week 12) and 26 or if participants were instructed by a physician that an LDL-C test was not needed.|Day 1 up to Week 26|The analysis was performed on the continuing users set which is a subset of the users set, defined as the users who continued taking the study medication for at least 6 weeks since the first date of the study treatment.|||Percentage of participants||95% Confidence Interval|Number
2619448|NCT01964300|Secondary|Progression-free Survival (PFS)|PFS estimates for each stratum were estimated using the method of Kaplan and Meier. PFS was defined as the time interval from date on treatment to the earliest date of disease progression, second malignancy, or death; or to date of last contact for patients without events. One- and two-year PFS estimates are reported by stratum. Only eligible patients were included in this analysis (7 stratum 1 patients and 11 stratum 2 patients).|2 years after treatment start|The one ineligible stratum 2 patient enrolled on the study was excluded from this analysis, leaving 7 stratum 1 patients and 11 stratum 2 patients.|||percentage of participants||95% Confidence Interval|Number
2619449|NCT01964300|Secondary|Sustained Objective Response (PR+CR) Rate Observed During the First Year of Treatment (for Stratum 1 Patients Only)|Objective responses had to be sustained for 3 months. The percentage of participants with sustained objective responses is reported with an exact 95% confidence interval of the true sustained objective response rate.|Up to 1 year|The seven stratum 1 patients are included in this analysis. This outcome measure was a *primary* outcome measure for stratum 2 patients and is therefore reported as a separate outcome measure for stratum 2.|||percentage of participants||95% Confidence Interval|Number
2619450|NCT01964300|Primary|Sustained Objective Response (PR+CR) Rate Observed During the First Year of Treatment (for Stratum 2 Patients Only)|Objective responses had to be sustained for 3 months. The percentage of participants with sustained objective responses is reported with an exact 95% confidence interval of the true sustained objective response rate.|Up to 1 year|Only eligible stratum 2 patients are included in this analysis. This is a *secondary* outcome measure for stratum 1 patients and is therefore reported as a separate outcome measure.|||percentage of participants||95% Confidence Interval|Number
2619451|NCT01964300|Primary|Rate of Disease Stabilization at 1 Year (i.e., 9 Courses of Treatment) (for Stratum 1 Patients Only)|The percentage of stratum 1 patients with disease stabilization at 1 year is reported, along with a 95% exact confidence interval for the estimate of the true 1-year disease stabilization rate.|Up to 1 year|This primary outcome measure only relates to stratum 1 patients.|||percentage of participants||95% Confidence Interval|Number
2619452|NCT01964222|Secondary|Attitudes About Cancer Clinical Trials|A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include two items in which participants rank their intent to participate in a cancer clinical trial and their intent to encourage others to participate in a cancer clinical trial on a 5-point scale with higher numbers indicating greater intent. Participation in study concludes upon completion of questionnaire.|1 day (Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of participant-reported intent.|||units on a scale of 1 to 5||Standard Deviation|Mean
2619453|NCT01964222|Primary|Uncertainty in Choice|"A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include the Uncertainty Subscale to evaluate decisional conflict. The subscale includes two items from the ten-item Low Literacy Decisional Conflict Scale, each with three response categories. The combined score on the two items will be divided by 2 and multiplied by 25 to produce an overall uncertainty score from 0 to 100. Higher values represent more uncertainty. Participation in study concludes upon completion of questionnaire."|1 day Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of calculated uncertainty.|||units on a scale of 0 to 100||Standard Deviation|Mean
2619454|NCT01964222|Primary|Clarity of Values|"A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include the Values Clarity Subscale to evaluate decisional conflict. The subscale includes two items from the ten-item Low Literacy Decisional Conflict Scale, each with three response categories. The combined score on the two items will be divided by 2 and multiplied by 25 to produce an overall values clarity score from 0 to 100. Higher values represent less clarity. Participation in study concludes upon completion of questionnaire."|1 day (Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of calculated values clarity.|||units on a scale of 0 to 100||Standard Deviation|Mean
2619707|NCT01961167|Secondary|Change in Functional Status - EQ5D - Self Care|Change in functional status (EQ5D - Self Care) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.|30 days|Population includes subjects followed for at least 23 days and had relevant data.|||Participants|||Count of Participants
2619456|NCT01964222|Primary|Knowledge About Cancer Clinical Trials|"A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials. The questionnaire will include eleven knowledge items such as Only very sick patients are asked to take part in a cancer research study and Cancer research studies almost never involve the use of a placebo or sugar pill alone. Participants will indicate each item as True, False, or I don't know. An overall knowledge composite score will be created with the average percentage of items participants in each condition correctly answer. Participation in study concludes upon completion of questionnaire."|1 day (Immediately following either showing the participant the experimental or control information (same day)|Analysis is represented as mean (standard deviation) of percentage of knowledge questions answered correctly.|||percentage questions answered correctly||Standard Deviation|Mean
2619457|NCT01964105|Primary|Breast Q Augmentation Module|BREAST-Q is a validated measures of patient reported outcomes (this is not an acronym). For this study we utilized the preoperative and postoperative BREAST -Q designed to analyze outcomes following breast augmentation The BREAST-Q is measured as a Q-score on a scale of 0-100. 0 is a poor score, 100 is an optimal score. Q-scores stand independently and are not combined to create a total score.|up to 6 months postop visit.||||units on a scale||Standard Deviation|Mean
2619458|NCT01963845|Secondary|HOMA-IR, Homeostatic Model Assessment of Insulin Resistance|HOMA-IR, calculated as [(glucose (mg/dL) X insulin (mg/dL)) / 405 ] at baseline and 24 weeks|Baseline and 24 weeks|All participants with HOMA-IR calculated at baseline and 24 weeks|||HOMA-IR score||Inter-Quartile Range|Median
2619459|NCT01963845|Secondary|LDL, Low-density Lipoprotein|LDL, measured in mg/dL at baseline and 24 weeks|Baseline and 24 weeks|All participants with LDL measurements at baseline and 24 weeks|||mg/dL||Inter-Quartile Range|Median
2619460|NCT01963845|Secondary|ALT, Alanine Aminotransferase|ALT, measured in IU/L at baseline and 24 weeks|Baseline and 24 weeks|All participants with ALT measurements at baseline and 24 weeks|||IU/L||Inter-Quartile Range|Median
2619461|NCT01963845|Secondary|AST, Aspartate Aminotransferase|AST, measured in IU/L at baseline and 24 weeks|Baseline and 24 weeks|All participants with AST measurements at baseline and 24 weeks|||IU/L||Inter-Quartile Range|Median
2619462|NCT01963845|Primary|Percentage Change in Liver Fat Relative to Baseline Assessed by MRI-PDFF|Participants liver fat was measured at baseline and 24 weeks. This is the percentage change in liver fat assessed by MRI-PDFF and stratified by treatment group.|Baseline and 24 weeks||||percentage change in liver fat||Standard Deviation|Mean
2619463|NCT01963767|Secondary|Cognitive Performance|The secondary endpoint will be improvement in cognitive performance over the two-month follow-up period on the paper and pencil tests of cognitive ability. The test that was used here is the Identical Pictures test, from the Educational Testing Services battery (Ekstrom RB, French JW, Harman HH, Dermen D. Manual for kit of factor referenced cognitive tests. Educational Testing Service, Princeton, NJ, 1976.). This test evaluates the number of pictures that persons can match within a 90 second period. There are two trials at 90 seconds and the maximum score is 48 matches (minimum is 0). Higher scores indicate better performance because participants are able to make more matches within the 90 second interval. This test provides an index of processing speed, the ability to do a task rapidly.|Measured at baseline and two months||||units on a scale||Standard Error|Mean
2619464|NCT01963767|Primary|Delay Eyeblink Conditioning|"Participants will be tested on eyeblink classical conditioning at the USF Health Byrd Alzheimer's Institute. Participants will receive 60 trials of eyeblink conditioning at the two-month follow-up point. Participants watch an entertaining silent video (e.g., Milo and Otis). The airpuff is delivered through a nozzle held in front of the participant and blink latency is recorded.~The outcome measure is an index of the percentage of eyeblinks that are made to a tone (conditioned stimulus) after the learning period is complete. The percentage can range from 0% (no conditioned learning has occurred) to 100% (all responses are conditioned; Woodruff-Pak, D. S. (2001). Eyeblink classical conditioning differentiates normal aging from Alzheimer's disease. Integrative Physiological and Behavioral Science, 36(2), 87-108.)."|Measured at the end of the intervention period, which is two months after initiation of the placebo of NT-020 doses|From the 105 persons with complete data on the second outcome, only 102 had complete data on this outcome. The three who did not contribute to this analysis were because there were two equipment failures and one person had a glass eye and the procedure could not be performed.|||percentage of conditioned responses||Standard Deviation|Mean
2619465|NCT01963676|Secondary|Persistence of Decrease in AHRS Score Over Time|We will re-assess patients one month after the completion of stimulation to evaluate whether their change from baseline to day 5 score on the AHRS persisted over time, namely 30 days.|Day 5, One month|Per protocol; All participants who completed every session of the study from the initial session through the one month follow-up.|||units on a scale||Standard Deviation|Mean
2619466|NCT01963676|Primary|Change in Auditory Hallucination Rating Scale (AHRS)Score From Baseline to Day 5|Examining AHRS total score after 5 days of stimulation compared to baseline assessment total.|Baseline, Day 5|Per protocol; All participants who completed every session of the study from the initial session through the one month follow-up.|||units on a scale||Standard Deviation|Mean
2619467|NCT01963611|Secondary|Mean Change From Baseline in Brain Volume Per Subject|Change from baseline in brain volume per subject was calculated using 5 series MRI scan.|Baseline, Weeks 24, 28, 32, 36, 40|The Outcome Measure was not derived due to early termination of the study.||||||
2619468|NCT01963611|Secondary|Time to First Relapse|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0.|Baseline up to Week 40|The Outcome Measure was not derived due to early termination of the study.||||||
2619483|NCT01963403|Primary|Number of Participants With Bleeding Improvement|Bleeding improvement will be measured by participant response to the question of whether she feels her bleeding is improved and she is satisfied with the treatment.|Bleeding improvement will be evaluated during first cycle of study treatment (28 days)|1 person in each group LTFU at one month, which was the primary outcome|||Participants|||Count of Participants
2619471|NCT01963611|Secondary|Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan|New, unenhancing T1 lesions (Black Holes) per subject and scan was calculated using 5 Serial MRIs.|Weeks 12, 24, 28, 32, 36, 40|ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.|||lesions/subject/scan||Standard Deviation|Mean
2619472|NCT01963611|Secondary|Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan|New or enlarging Time Constant 2 (T2) lesions per subject and scan was calculated using 5 serial MRI scans.|Weeks 12, 24, 28, 32, 36,40|ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.|||lesions/subject/scan||Standard Deviation|Mean
2619473|NCT01963611|Secondary|Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan|T1 Gd-enhancing lesions per subject and scan was measured using 5 serial MRI scans.|Weeks 12, 24, 28, 32, 36, 40|"ITT analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||lesions/subject/scan||Standard Deviation|Mean
2619474|NCT01963611|Secondary|Percentage of Subjects Remaining Relapse-Free|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0.|Baseline up to Week 40|Safety Analysis Set (SAF) includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).|||percent subjects|||Number
2619475|NCT01963611|Secondary|Mean Annualized Relapse Rate (ARR)|Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Annualized Relapse Rate was calculated as = 365.25 x (Number of relapses during Treatment Period) per (Number of days on treatment during Treatment Period).|Baseline up to Week 40|Safety Analysis Set (SAF) includes all randomized subjects who had received at least 1 dose of investigational medicinal product (IMP).|||percent relapse||Standard Deviation|Mean
2619476|NCT01963611|Primary|Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan|Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions per Subject and Scan was calculated using 5 serial magnetic resonance imaging (MRI) scans.|Baseline , Week 12, 24, 28, 32, 36, 40|Intent to Treat (ITT) analysis set included all randomized subjects with at least 1 post-baseline efficacy (MRI) assessment. Here 'n' signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively.|||lesions per subjects per scan||Standard Deviation|Mean
2619477|NCT01963481|Secondary|Clinical Benefit Rate Score|Clinical benefit rate is defined as the percentage of patients who have achieved objective response or stable disease for at least 24 weeks. Evaluation of response and disease progression is based on RESIST guideline version 1.1. Response and progression are assessed every 12 weeks.|3 years||||percent of participants||95% Confidence Interval|Number
2619478|NCT01963481|Secondary|Response Rate (RR) - Complete Response and Partial Response|Complete response (CR) is defined as the disappearance of all target lesions, while partial response (PR) is when at least a 30% decrease in the sum of the diameters of target lesions. Evaluation of response is based on RESIST guideline version 1.1. RR is reported as percentage of participants with a CR and/or PR at 2 years.|2 years||||percent of participants||95% Confidence Interval|Number
2619479|NCT01963481|Primary|Progression-free Survival (PFS) Rate at 3 Months|PFS is defined as the time from first treatment day until objective disease progression or death from any cause. Assessment of disease progression based on Response Evaluation Criteria in Solid Tumor (RESIST) guideline version 1.1 is performed every 12 weeks on study. The percent of participants with PFS at 3 months will be reported.|3 months||||percent of participants||95% Confidence Interval|Number
2619480|NCT01963403|Other Pre-specified|Bleeding Patterns and Number of Participants With Bleeding Improvement|"Bleeding improvement in women who received placebo but opted for open-label treatment after first cycle~Bleeding improvement over the 84 days of study participation~Bleeding patterns in placebo vs. combined oral contraceptive users"|Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months||||Participants|||Count of Participants
2619481|NCT01963403|Other Pre-specified|Number of Participants withTreatment Success or Failure|"Treatment success will be measured by desire to continue treatment because the initial treatment made the bleeding better.~Partial failure of the study treatment will be measured by the desire to continue treatment because the initial treatment did not work~Complete failure of treatment will be measured by the desire to:~discontinue treatment because it did not work; no further treatment requested~ETG implant removal~Desire to use non-study treatment"|Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months|one month evaluation; 1 subject LTFU at one month in each group|||Participants|||Count of Participants
2619482|NCT01963403|Secondary|Number of Participants With Adverse Events|Participants will be evaluated for adverse events while using a combined oral contraceptive with ETG implant.|Adverse events will be evaluated at each contact (visits at 1 and 3 months, phone contact at 2 months) with the participant|Outcomes at one month; 1 person LTFU at one month in each group|||Participants|||Count of Participants
2619517|NCT01963091|Secondary|Likert Scale Rating of Subjective Craving|Subjects will rate craving on 10-point Likert scale before and after drug administration and stress task with 0 being 'not at all' and 10 being 'extremely'|0 mintues post 15 minute stress task||||units on a scale||Standard Deviation|Mean
2619484|NCT01963260|Secondary|Maximum Concentration (Cmax) of MK-8723 Among Healthy Participants and Participants With ITP|Serum samples for determination of Cmax were collected at pre-specified time-points.|All dose groups: Predose and 4 (end of infusion), 6, 12, 24 hrs postdose and Days 3, 4, 5, 7, 10, 14, 21, 28; 30 mg/kg and 100 mg/kg dose groups: Days 43, 56, 71, 84|The per protocol population consisting of all participants in compliance with the protocol (e.g., availability of measurements, absence of major protocol violations) was used for this pharmacokinetic (Cmax) analysis.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2619485|NCT01963260|Secondary|Area Under the Concentration-time Curve of MK-8723 From Time 0 to Infinity (AUC0-∞) Among Healthy Participants and Participants With ITP|AUC0-∞ is a measure of total body exposure to drug. Serum samples for determination of AUC0-∞ were collected at pre-specified time-points.|All dose groups: Predose and 4 (end of infusion), 6, 12, 24 hrs postdose and Days 3, 4, 5, 7, 10, 14, 21, 28; 30 mg/kg and 100 mg/kg dose groups: Days 43, 56, 71, 84|The per protocol population consisting of all participants in compliance with the protocol (e.g., availability of measurements, absence of major protocol violations) was used for the pharmacokinetic (AUC0-∞) analysis.|||hr*μg/mL||Geometric Coefficient of Variation|Geometric Mean
2619486|NCT01963260|Primary|Number of Participants With a Positive Platelet Response to MK-8723|In participants with ITP, platelet response is a rapid, sensitive, and highly qualitative measure of response to anti-inflammatory therapy. A positive platelet response was defined as: 1) A doubling of platelet counts at the time point of maximum response (through Day 14) as compared to Day 0 AND an increase to an absolute level of ≥50,000/μL in participants with a baseline platelet count of <50,000/μL, OR 2) A 50% increase in the platelet count at the time point of maximum response (through Day 14) as compared to Day 0 in participants with a baseline platelet count of ≥50,000/μL. The analysis was specified only for participants with ITP (Part 2) that received treatment with MK-8723 or matching placebo.|Up to Day 14|The per protocol population consisting of all participants in compliance with the protocol (e.g., availability of measurements, absence of major protocol violations) was used for the pharmacodynamic (platelet response) analysis.|||Participants|||Number
2619487|NCT01963260|Primary|Number of Participants Discontinuing Study Due to an Adverse Event (AE)|An AE is defined as any unfavorable and unintended medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 84 Days|The APaT population consisting of all participants who received at least one dose of study drug was used for the safety analysis.|||Participants|||Number
2619488|NCT01963260|Primary|Number of Participants Experiencing an Adverse Event|An AE is defined as any unfavorable and unintended medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 84 days|The All Participants as Treated (APaT) population consisting of all participants who received at least one dose of study drug was used for the safety analysis.|||Participants|||Number
2619489|NCT01963234|Secondary|Total Costs for Clinic|This includes the clinic operating costs and clinic implementation costs of the intervention.|6 months|"This outcome measure was analyzed at the clinic level. Thus, NA is indicated for Overall number of participants analyzed."|||US dollars|clinic||Number
2619490|NCT01963234|Secondary|Clinical Adoption|We analyzed computerized system log files to produce patterns of system adoption of the staff.|up to 3 years|This is the number of primary care clinical staff at the 3 sites who adopted using Seva.|||Participants|||Count of Participants
2619491|NCT01963234|Secondary|Number of Patients Using System|Analysis for measure was done for the total of all three sites combined.|up to 3 years||||Participants|||Count of Participants
2619492|NCT01963234|Primary|Patients Partook in HIV Testing in the Last 6 Months|Analysis for measure was done for the total of all three sites combined.|6 months|Overall number of participants analyzed is lower because data is self reported and patients could chose not to answer some questions.|||Participants|||Count of Participants
2619493|NCT01963234|Primary|Patients Partook in HIV Risky Behavior in the Last 6 Months|Analysis for measure was done for the total of all three sites combined.|6 months||||Participants|||Count of Participants
2619494|NCT01963234|Primary|Patients, Within the Last 6 Months Have Received Other Addiction Treatment|Analysis for measure was done for the total of all three sites combined.|6 months||||Participants|||Count of Participants
2619495|NCT01963234|Primary|Patient Had Any Drink or Drug Use Within the Last 30 Days|Analysis for measure was done for the total of all three sites combined.|6 months|Overall number of participants analyzed because data was self reported and patients were allowed to not answer questions if they chose.|||Participants|||Count of Participants
2619496|NCT01963234|Primary|Patient Had Illicit Drug Use Within the Last 30 Days|Analysis for measure was done for the total of all three sites combined.|6 months|Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.|||Participants|||Count of Participants
2619497|NCT01963234|Primary|Patient Had Any Drink Within the Last 30 Days|Analysis for measure was done for the total of all three sites combined.|6 months|Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.|||Participants|||Count of Participants
2619498|NCT01963234|Primary|Mental Subscale Quality of Life|Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. This consisted of 4 questions that had scaled ranging from 1 to 5. The scores of the scales were summed and values could range from 4 to 20.|6 months|Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.|||score on a scale||Standard Deviation|Mean
2619499|NCT01963234|Primary|Physical Subscale Quality of Life|Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. This scare consisted of 4 questions that had scales ranging from 1 to 5. The scores were summed and values could range from 4 to 20.|6 months|Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.|||score on a scale||Standard Deviation|Mean
2619500|NCT01963234|Primary|Overall Quality of Life|Analysis for measure was done for the total of all three sites combined. Higher values represent better quality of life. Value was calculated by adding the mental and physical subscale values. Values could range from 8 to 40.|6 months|Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.|||score on a scale||Standard Deviation|Mean
2619501|NCT01963234|Primary|Illicit Drug-use Within the Last 30 Days|Analysis for measure was done for the total of all three sites combined.|6 months|Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.|||days||Standard Deviation|Mean
2619502|NCT01963234|Primary|Risky Drinking Days in the Last 30 Days|Analysis for measure was done for the total of all three sites combined.|6 months|Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.|||days||Standard Deviation|Mean
2619503|NCT01963234|Primary|Any Drinking Days in Last 30 Days||6 months|Measure analyzed as a total among all three clinics. We told clinics that we would not report at the site level. We believed that it could reflect poorly on the organization if a site appeared poorly with regard to outcomes in relation to others.|||days||Standard Deviation|Mean
2619504|NCT01963234|Primary|Implementation Status|The number of implementation milestones completed|up to 3 years|These are milestones achieved for each site.|||milestones|Milestones||Number
2619505|NCT01963169|Primary|Changes in Exercise Time|Exercise behavior was assessed using the 6-item exercise subscale that is part of the Yale Physical Activity Survey. (Higher value is better.)|8 weeks|Participants who completed the 8-week survey.|||minutes||Standard Deviation|Mean
2619506|NCT01963169|Primary|Changes in Calcium Intake|Dietary calcium intake was estimated using a short screening tool developed by Blalock et al. 4. It includes 22 items that assess both frequency and portions various foods that contain calcium and vitamin D. (Higher values are better.)|8 weeks|Participants who completed the 8-week survey.|||mg||Standard Deviation|Mean
2619507|NCT01963169|Primary|Changes in Osteoporosis Knowledge, Self-efficacy/Outcome Expectations for Calcium Intake and Exercise, Health Behaviors (Calcium Intake, Exercise)|"The 16-item knowledge on osteoporosis was measured using the revised Osteoporosis Knowledge Test (Range: 0 - 23 [higher better])~The 11-item self-efficacy for calcium intake subscale of the Osteoporosis Health Belief Scale. (Range: 11 - 110 [higher better])~The 9-item self-efficacy for Exercise scale. (Range: 0 - 90 [higher better])~The 6-item calcium intake outcome expectation subscale of the Osteoporosis Health Belief Scale (Range: 6 -30[higher better])~The 9-item outcome expectations for Exercise Scale. (scoring: range: 9 - 45 [higher better])"|8 weeks|Participants who completed the 8-week survey.|||units on a scale||Standard Deviation|Mean
2619508|NCT01963143|Secondary|Secondary Bioequivalence Analysis - IgG Trough Levels||After a minimum 5 infusions on each product, at pre-infusion.||||ratio Gammaplex 10%/Gammaplex 5%||90% Confidence Interval|Geometric Mean
2619509|NCT01963143|Secondary|Secondary Bioequivalence Analysis - Area Under the Curve Within a 21-Day Dosing Interval (AUC0-21) in Adult Subjects||After a minimum 5 infusions on each product, at pre-infusion, 10 minutes before end of infusion, 1, 3, 6, 24, 48 hours, 4, 7, 14 and 21 days post-infusion||||ratio Gammaplex 10%/Gammaplex 5%||90% Confidence Interval|Geometric Mean
2619510|NCT01963143|Primary|Primary Bioequivalence Analysis - Area Under the Curve Within a 28-day Dosing Interval (AUC0-28) in Adult Subjects||After a minimum 5 infusions on each product, at pre-infusion, 10 minutes before end of infusion, 1, 3, 6, 24, 48 hours, 4, 7, 14, 21 and 28 days post-infusion|PK population|||ratio Gammaplex 10%/Gammaplex 5%||90% Confidence Interval|Geometric Mean
2619511|NCT01963117|Secondary|Overall Survival Rate After Combined Hyperthermia and RT|Overall survival will be measured from the date of RT start to the date of death or last follow-up visit.|Pathient will be evaluated at 3 month after combined hyperthermia and RT.||||Months||95% Confidence Interval|Mean
2619512|NCT01963117|Secondary|Adverse Event After Combined Hyperthermia and RT.|All grade III or higher toxicities (repeated measure)|Adverse event will be evaluated at 3 month. The common terminology criteria for adverse events (CTCAE) version 4.0 will be used.||||participants|||Number
2619513|NCT01963117|Secondary|Local Tumor Progression Free Survival Rate After Combined Hyperthermia and RT|Local progression will be defined as more than 20% size increase of metastatic lesions or new metastatic lesion in liver. Local progression free survival will be measured from the date of RT start to the date of local progression or last follow-up visit.|Response will be evaluated at 3 month after combined hyperthermia and RT. Modified RECIST will be used to define resopnse.||||Months||95% Confidence Interval|Mean
2619514|NCT01963117|Secondary|Change in the Grade of Quality of Life at 3 Months From That Before the Combined Hyperthermia and RT|To measure the quality of life, European Organisation for Research and Treatment of Cancer (EORTC)- quality of life questionnaire (QLQ) 30 and Functional Assessment of Cancer Therapy-Hepatobiliary will be used. (grade 1 to 4, 1; not at all, 2; a little, 3; quite a bit, 4; very much)|Quality of life will be ssessed at baseline and 3 months after combined hyperthemica and RT, data reported 3 months after combined hyperthemica and RT with grade from 1 to 4.|European Organisation for Research and Treatment of Cancer (EORTC)- quality of life questionnaire (QLQ) 30 and Functional Assessment of Cancer Therapy-Hepatobiliary will be used from grade 1 to 4.|||score on a scale||Full Range|Median
2619515|NCT01963117|Secondary|Objective Response Rate of Combined Hyperthermia and RT||Response will be evaluated at 3 month after combined hyperthermia and RT. Modified RECIST will be used to define resopnse.||||participants|||Number
2619516|NCT01963117|Primary|Time to Local Tumor Progression After Combined Hyperthermia and RT|Local progression will be defined as more than 20% size increase of metastatic lesions or new metastatic lesion in liver. Time to local tumor progression will be measured from the date of RT start to the date of local progression or last follow-up visit.|Patient will be evaluated after combined hyperthermia and RT until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 19 months.|Patients who underwent combined hyperthermia and radiation therapy|||Months||95% Confidence Interval|Mean
2619520|NCT01963078|Primary|Change in Amygdala Activation- Oxy Minus Placebo|Bold signal response to facial recognition task was contrasted between oxytocin and saline administrations. Participants with PTSD and Resilient Controls each underwent 2 sets of scanning procedures, one with placebo and one with Oxytocin. Participants were randomly assigned to received Oxytocin on Day 1 or Day 2, and placebo on the opposite day, to mitigate crossover effects. Outcome measure is change in bold signal response between the two days; bold signal response on placebo was subtracted from bold signal response on Oxytocin to obtain change score.|Days 1 and 2|Population analyzed are participants who completed both scans and had usable MRI data.|||percentage of BOLD signal change||Standard Deviation|Mean
2619521|NCT01962974|Secondary|Percentage of Participants Who Acheived ACR 20 Response at Week 24 With Trough Infliximab Levels Below the Lower Limit of Quantification (LLOQ)|The ACR 20 Response is defined as >= 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (010 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR.|Week 24|Due to early study termination, data for this outcome measure was not collected and therefore the analyses could not be conducted.||||||
2619522|NCT01962974|Secondary|Percentage of Participants Who Achieved an ACR 20 Response at Week 24 With Confirmed Presence of Antibodies to Infliximab|The ACR 20 Response is defined as >= 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (010 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR.|Week 24|Due to early study termination, data for this outcome measure was not collected and therefore the analyses could not be conducted.||||||
2619523|NCT01962974|Primary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 24|The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and erythrocyte sedimentation rate (ESR).|Week 24|Due to early study termination, data for this outcome measure was not collected and therefore the analyses could not be conducted.||||||
2619524|NCT01962961|Primary|Change in Flow-mediated Dilation (FMD) of the Brachial Artery|Measure of endothelial function|Baseline and 8 weeks|Analysis population includes those who completed the 8 week trial and had both baseline and week 8 values available.|||Percentage of vessel diameter||Standard Deviation|Mean
2619525|NCT01962961|Primary|Change in Circulating F2-isoprostane Levels|Oxidative stress measure|Baseline and 8 weeks|Analysis population includes those who completed the 8 week trial and had both baseline and week 8 values available.|||pg/mL||Standard Deviation|Mean
2619526|NCT01962961|Primary|Change in Circulating Malondialdehyde Levels|Measure of oxidative stress|Baseline and 8 weeks|Analysis population includes those who completed the 8 week trial and had both baseline and week 8 values available.|||micromolar||Standard Deviation|Mean
2619527|NCT01962922|Primary|Evaluation of C(Min) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 21|For this outcome measure the Protocol PK population N= 46 was used.|||ng/mL||Standard Deviation|Mean
2619528|NCT01962922|Primary|Evaluation of C(Max) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 21|For this outcome measuure the Protocol PK population of N = 46 was used.|||ng/mL||Standard Deviation|Mean
2619529|NCT01962922|Primary|Evaluation of AUC(0-24) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 21|For this outcome measure the PK population N=46 was used.|||ng*hr/mL||Standard Deviation|Mean
2619530|NCT01962922|Primary|Evaluation of C(Min) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours"|Day 14|For this outcome measuure the Protocol PK population N= 46 was used.|||ng/mL||Standard Deviation|Mean
2619531|NCT01962922|Primary|Evaluation of C(Max) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 14|For this outcome measuure the Protocol PK population of N = 46 was used.|||ng/mL||Standard Deviation|Mean
2619532|NCT01962922|Primary|Evaluation of AUC(0-24) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 14|For this outcome measure the PK population N=46 was used|||ng*hr/mL||Standard Deviation|Mean
2619533|NCT01962922|Primary|Evaluation of C(Min) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 7|For this outcome measure the Protocol PK population N= 46 was used.|||ng/mL||Standard Deviation|Mean
2619534|NCT01962922|Primary|Evaluation of C(Max) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 7|For this outcome measuure the Protocol PK population of N = 46 was used.|||ng/mL||Standard Deviation|Mean
2619535|NCT01962922|Primary|Evaluation of AUC(0-24) for Envarsus XR and IR-Tac|"Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below.~Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours."|Day 7|For this outcome measure the PK population N=46 was used.|||ng*hr/mL||Standard Deviation|Mean
2619536|NCT01962896|Secondary|The Progression-free Interval (PFI) for Patients With Germ Cell Tumors With and Without Evidence of EGFR/mTOR Pathway Activation With This Drug Combination.||3 years|Analysis was not performed as the study was terminated early without sufficient enrollment to analyze this objective.||||||
2619537|NCT01962896|Secondary|The Incidence of EGFR and mTOR Pathway Activation in Banked Tumor Specimens.||3 years|Analysis was not performed as the study was terminated early without sufficient enrollment to analyze this objective.||||||
2619538|NCT01962896|Primary|The Toxicities of the Combination of Sirolimus and Erlotinib Administered on This Schedule.|The number of patients with drug related grade III, IV, or V adverse events according to the Common Terminology Criteria for Adverse Events version 4.0.|2 years||||Participants|||Count of Participants
2619539|NCT01962896|Primary|The PFR, Defined as the Proportion of Patients With Refractory Germ Cell Tumors Free of Objective Disease Progression After 4 Cycles (16 Weeks) of Therapy With Erlotinib and Sirolimus|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Progressive Disease (PD), >= 20% increase in the sum of the longest diameter of target lesions or the development of any new lesions|16 weeks||||percentage of patients|||Number
2619540|NCT01962870|Secondary|Change From Baseline in Plasma Vasopressin Levels During Treatment.|There are no clinical laboratory tests that establish a normative range for vasopressin. Measurements prior to treatment were intended to evaluate vasopressin level as a predictor of response. Plasma vasopressin levels post treatment were not quantified. Baseline vasopressin levels are included in the outcome data below.|Baseline|Participants with available data were included in the analysis.|||pg/ml||Standard Error|Mean
2619541|NCT01962870|Secondary|Change From Baseline in a Developmental Neuropsychological Assessment, Second Edition. (NEPSY-II) Affect Recognition Scores During Treatment.|"Higher Affect Recognition scores mean better affect recognition abilities, lower Affect Recognition scores mean worse affect recognition abilities.~Scores can range from 1 to 19."|Baseline; Week 4|Participants with available data were included.|||units on a scale||Standard Error|Least Squares Mean
2619542|NCT01962870|Secondary|Change From Baseline in the Awareness of Social Inference Test Revised (TASIT-R) Scores During Treatment.||Baseline, Week 4|Data were not not collected for this outcome.||||||
2619543|NCT01962870|Secondary|Change From Baseline in Body Temperature After Treatment||Baseline; Week 4|Participants with available data are included in the analysis.|||Degrees (Farenheit)||Standard Error|Least Squares Mean
2619544|NCT01962870|Secondary|Change From Baseline in Body Weight After Treatment.||Baseline; Week 4|Participants with available data are included in the analysis.|||kilograms||Standard Error|Least Squares Mean
2619545|NCT01962870|Secondary|Change From Baseline in Blood Pressure After Treatment|Sitting Systolic and Diastolic blood pressure.|Baseline; Week 4|Participants with available data are included in the analysis.|||mmHG||Standard Error|Least Squares Mean
2619546|NCT01962870|Secondary|Change From Baseline in Laboratory Based Social Mimicry Abilities During Treatment.||Baseline; Week 4|Data were not not collected for this outcome.||||||
2619547|NCT01962870|Secondary|Change From Baseline in Laboratory Based Eye-gaze to Social Cues During Treatment.||Baseline; Week 4|Data were not not collected for this outcome.||||||
2619548|NCT01962870|Secondary|Change From Baseline in Clinical Chemistry Labs (NA+, K+, Cl-) During Treatment.|Clinical chemistry labs(sodium, potassium, chloride)|Baseline; Week 4|Participants with available data are included in the analysis.|||mmol/L||Standard Error|Least Squares Mean
2619549|NCT01962870|Secondary|Change From Baseline in Parent Rated Vineland Adaptive Behavior Scales Second Edition (VABS-II) - Social and Communication Subscales During Treatment.|Higher Social Standard Score means better social skills, lower Social Standard Score means worse social skills. Higher Communication Standard Score means better communication skills, lower Communication Standard Score means worse communication skills. Standard Scores can range from 20 to 160.|Baseline; Week 4|Not all participants were able to fully complete the measure so not all of the numbers analyzed are the same.|||units on a scale||Standard Deviation|Mean
2619550|NCT01962870|Secondary|Change From Baseline in Parent Rated Pediatric Quality of Life (PedQL) Inventory Scores During Treatment.|Higher scores mean better quality of life and lower scores mean worse quality of life (Range: Minimum=0; Maximum=100).|Baseline; Week 4|Participants with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2619570|NCT01962675|Secondary|Change From Baseline Scores of a 10 m Walk Test|Change from baseline score of the time required to perform 10 m walking.|Two times, 1) Baseline, and 2) Up to 1 hour after intervention.|Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.||||||
2619551|NCT01962870|Secondary|Change From Baseline in Parent Rated Aberrant Behavior Checklist (ABC) Scores During Treatment.|Higher scores indicate more symptoms, lower scores indicate fewer symptoms. Irritability scores can range from 0-45. Lethargy scores can range from 0-48. Stereotypy scores can range from 0-21. Hyperactivity scores can range from 0-48. Inappropriate speech scores can from 0-12.|Baseline; Week 4|Participants with available data were included in analysis.|||units on a scale||Standard Deviation|Mean
2619552|NCT01962870|Secondary|Change From Baseline in Heart Rate After Treatment.|Sitting heart rate (beats per minute).|Baseline; Week 4|Participants who completed the protocol are included in the analysis.|||Beats per minute||Standard Error|Least Squares Mean
2619553|NCT01962870|Secondary|Change From Baseline on the Overt Aggression Scale (OAS) During Treatment.|Count of participants reporting an increase of aggression during treatment compared to baseline (pretreatment).|Baseline through Week 4|Participants with available data are included in the analysis.|||Participants|||Count of Participants
2619554|NCT01962870|Secondary|Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment|Dosage Record Treatment Emergent Symptom Scale (DOTES) side effects reported by parents during 4-weeks of treatment. Participant Counts are used.|Baseline through Week 4|Participants who completed the protocol are included in the analysis.|||participants|||Number
2619555|NCT01962870|Secondary|Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment.|Scale measuring severity of anxiety symptoms. Higher scores mean higher levels of anxiety, lower scores mean lower levels of anxiety. (Raw Score Range: 0 - 114)|Baseline; Week 4|Participants with available data were analyzed.|||units on a scale||Standard Error|Least Squares Mean
2619556|NCT01962870|Secondary|Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.|Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129)|Baseline; Week 4|Participants with available data were analyzed.|||units on a scale||Standard Error|Mean
2619557|NCT01962870|Secondary|Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment.|Higher scores mean better facial emotion recognition abilities. Lower scores mean worse facial emotion recognition abilities (Range: 0-42).|Baseline; Week 4|Participants with available data are included in the analysis.|||units on a scale||Standard Error|Mean
2619558|NCT01962870|Secondary|Change From Baseline in Reading the Mind in the Eyes Test, Child Version (RMET-child) Scores During Treatment.|Higher scores mean better ability to read emotions and lower scores mean worse ability to read emotions. Range 0-28.|Baseline; Week 4|Participants with available data are included in the analysis.|||units on a scale||Standard Error|Mean
2619559|NCT01962870|Secondary|Change From Baseline in Clinical Global Impression (CGI) Severity, Social and Communication Scores During Treatment.|Higher Scores on the CGI severity scale mean more greater social and communication deficits (Range 1-7)|Baseline; Week 4|Participants with available data are included.|||units on a scale||Standard Error|Least Squares Mean
2619560|NCT01962870|Primary|Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.|Social Responsiveness Scale, 2nd Edition (SRS) scores measure social abilities with lower scores meaning better social abilities. (T-Score Range: 37- above 90 )|Baseline; Week 4|Participants who completed the protocol are included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2619561|NCT01962714|Primary|NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Score|Depression was assessed using the National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) depression measure. This scale utilizes item-response theory and is scored using a T-score metric with a mean of 50 and SD=10 in the US general population. Higher scores indicate more severe depression.|6 months post-intervention||||units on a scale||95% Confidence Interval|Mean
2619562|NCT01962714|Primary|Clinician Administered PTSD Scale (CAPS-5) Score|PTSD diagnostic severity was measured using the 30-item CAPS-5 structured interview (range 0-80; higher scores indicate worse PTSD). Linear mixed effects models (LMM) were used to analyze continuous outcomes, with time and time by treatment interaction included as fixed effects to determine if differences exist between conditions by time. Non-inferiority of LKM to CPT-C was claimed if the lower limit of the 95% confidence interval for difference in change rate from baseline to 6-month follow-up in mean CAPS or depression score was greater than (i.e., did not extend beyond) negative delta (defined as 5 points on the CAPS-5 measure). A 2-sided 95% confidence interval of the difference in change rate from baseline to 6-month follow-up between groups (CPT-C minus LKM) was calculated, with a positive value indicating a greater reduction in scores from baseline for LKM compared to CPT-C.|6 months post-intervention||||units on a scale||95% Confidence Interval|Mean
2619563|NCT01962688|Secondary|Length of Stay|length of stay in the hospital for inpatient arms only|up to 6 months|Data not collected||||||
2619564|NCT01962688|Secondary|Change in Health Related Quality of Life|Change in Health related quality of life at 6 months as compared to at 1 month|1 month and 6 months|Data not collected||||||
2619565|NCT01962688|Secondary|Number of Participants in Each New York Heart Association Class|"New York Heart Association (NYHA) Classification Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.~Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.~Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100m). Comfortable only at rest.~Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients."|6 months|Analyzed total 96 visits|||visits|Number of Visits||Number
2619566|NCT01962688|Primary|Diuretic Change Post-visit|Differences in Changes made in Diuretic doses after Heart failure related visit|6 months followup||||Number of visits|Number of visits||Count of Units
2619567|NCT01962688|Primary|Number of Participants Hospitalized for Non-cardiac Reasons|hospitalization information will be recorded throughout the length of the study for the inpatient arms|up to 6 months|All patients in clinical assessment only group were hospitalized for non-cardiac reasons|||Participants|||Count of Participants
2619568|NCT01962688|Primary|Number of Participants Hospitalized for Cardiovascular Reasons|hospitalization information will be recorded throughout the length of the study for the outpatient arms|up to 6 months||||Participants|||Count of Participants
2619571|NCT01962675|Primary|Change From Baseline Active Motor Threshold|Measuring Active motor threshold using single pulse transcranial magnetic stimulation (TMS) of Motor cortex M1 area|Two times, 1) Baseline, and 2) Up to 1 hour after intervention.|Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.||||||
2619572|NCT01962675|Primary|Change From Baseline Midswing Ankle ROM|Measuring Ankle range of motion (ROM) first at Baseline and then up to 1 hour after intervention at the Midswing phase during Gait.|Two times, 1) Baseline, and 2) Up to 1 hour after intervention.|Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.||||||
2619573|NCT01962558|Other Pre-specified|Change in Tinnitus Functional Index (TFI)|Assess the change in TFI score for both groups and compare between the groups. The TFI has eight subscales that address the intrusiveness of tinnitus, the sense of control the patient has, cognitive interference, sleep disturbance, auditory issues, relaxation issues, quality of life, and emotional distress. There are a total of 25 questions, with a range of 0 to 10 on each item (0 to 250) total. All valid answers are summed, divided by the number of questions which were answered, and multiplied by 10 (0-100 range). Score range from 0 to 100 with higher scores indicating worse tinnitus.|6-weeks (pre-implant to after 6-weeks of VNS)||||units on a scale||95% Confidence Interval|Mean
2619574|NCT01962558|Secondary|Change in Tinnitus Handicap Questionnaire (THQ)|Assess the change in THQ score for both groups and compare between the groups. The THQ is a patient questionnaire with 27 questions with each question having a score from 1 to 100. Scoring includes three factors - Factor 1 (Social, Emotional, Behavioral), Factor 2 (Tinnitus and Hearing), Factor 3 (Outlook). Fifteen questions are included in Factor 1, 8 questions in Factor 2, and 4 questions in Factor 3. A total score is calculated by adding the scores for Factor 1 questions and multiplying by 15/27, adding the scores for Factor 2 and multiplying by 8/27, and adding the scores for Factor 3 and multiplying by 4/27. This is then summed for the total score. Total score ranges from 0 to 100, with higher scores indicating more severe tinnitus.|6-weeks (pre-implant to after 6-weeks of VNS)||||units on a scale||95% Confidence Interval|Mean
2619575|NCT01962558|Secondary|Percent Change in Tinnitus Handicap Inventory (THI)|Assess the change in THI score for both groups and compare between the groups. The THI is a questionnaire that asks subjects to assess their perception of their tinnitus by rating each question as a Yes (4 points), No (0 points) or Sometimes (2 points). There are 25 questions, scores are summed, so the scale ranges from 0 to 100. Scores are graded as: Grade 1 - Slight (0-16) Only heard in a quiet environment; Grade 2 - Mild (18-36) Easily masked by environmental sounds and easily forgotten with activities.; Grade 3 - Moderate (38-56) Noticed in presence of background noise, although daily activities can still be performed.; Grade 4 - Severe (58-76) Almost always heard, leads to disturbed sleep patterns and can interfere with daily activities.; Grade 5 - Catastrophic (78-100) Always heard, disturbed sleep patterns, difficulty with any activities.|6-weeks (pre-implant to after 6-weeks of VNS)||||percentage change of THI||95% Confidence Interval|Mean
2619576|NCT01962558|Secondary|Change in Minimum Masking Level (MML) in Units of dB (Decibels)|Asses the change in minimum masking level (MML) for both groups and compare between the groups.|6-weeks (pre-implant to after 6-weeks of VNS)||||dB (decibels)||95% Confidence Interval|Mean
2619577|NCT01962558|Secondary|Number of Participants With Adverse Events|Assess the number of adverse events during the study, and compare between groups to indicate if there are more in the treatment group than the control group.|6-weeks||||participants|||Number
2619578|NCT01962558|Primary|Number of Participants With Serious Adverse Events|Assess the number of serious adverse events during the study, and compare between groups to indicate if there are more in the treatment group than the control group.|6-weeks||||participants|||Number
2619579|NCT01962493|Secondary|Overall Gingival and Interproximal MLSI at Week 6|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 6 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.|||Score on a Scale||Standard Deviation|Mean
2619580|NCT01962493|Secondary|Overall Gingival and Interproximal MLSI at Week 3|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 3 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.|||Score on a Scale||Standard Deviation|Mean
2619581|NCT01962493|Secondary|Overall Interproximal MLSI at Week 6|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 6 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.|||Score on a Scale||Standard Deviation|Mean
2619595|NCT01962428|Secondary|Bleeding Events||follow-up for 28 days after the loading dose of ticagrelor|||||||
2619582|NCT01962493|Secondary|Overall Interproximal MLSI at Week 3|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 3 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.|||Score on a Scale||Standard Deviation|Mean
2619583|NCT01962493|Secondary|Overall Facial MLSI at Week 6|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 6 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.|||Score on a Scale||Standard Deviation|Mean
2619584|NCT01962493|Secondary|Overall Facial MLSI at Week 3|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 3 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.|||Score on a Scale||Standard Deviation|Mean
2619585|NCT01962493|Secondary|Overall MLSI at Week 3|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 3 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 3 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.|||Score on a Scale||Standard Deviation|Mean
2619586|NCT01962493|Primary|Modified Lobene Stain Index (MLSI) at Week 6|An assessment of the area and intensity of dental stain on the study teeth was performed using the MLSI after usage of 0.2% w/v chlorhexidine digluconate mouthwash for 6 weeks. The intensity of stain was scored on a scale of 0 to 3 (0 - no stain, 1- light stain, 2 - moderate stain, 3 - heavy stain). The area of stain was scored on the following scale: 0 - no stain; 1 - stain up to 1/3 of the area affected; 2- stain between 1/3 and 2/3 of the area affected; and 3 - stain more than 2/3 of area affected. Intensity X Area was thus analyzed on a scale of 0 (best score) to 9 (worst score).|Week 6 post treatment administration|The efficacy analysis was performed on the Intent-to-treat (ITT) population which consisted of all participants who were randomized and received the study treatment and completed one of the post-baseline efficacy assessments.|||Score on a Scale||Standard Deviation|Mean
2619587|NCT01962441|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2619588|NCT01962441|Secondary|Percentage of Participants Experiencing On-Treatment Virologic Failure|"On-treatment virologic failure was defined as:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
2619589|NCT01962441|Secondary|Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12||Baseline; Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2619590|NCT01962441|Secondary|HCV RNA at Weeks 1, 2, 4, 8, and 12||Weeks 1, 2, 4, 8, and 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2619591|NCT01962441|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24||Weeks 1, 2, 4, 8, 12, 16, 20, and 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2619592|NCT01962441|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
2619593|NCT01962441|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2619594|NCT01962441|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2619597|NCT01962428|Primary|Platelet Reactivity Index(PRI) Measured by VASP-P|Vasodilator-stimulated phosphoprotein(VASP) phosphorylation, a measure of P2Y12 receptor reactivity, was determined by flow cytometry with the use of the Platelet VASP-FCM Kit (Stago, France)and recorded as the platelet reactivity index (PRI).|2 hours after the loading dose of ticagrelor||||percentage of 100||Inter-Quartile Range|Median
2619598|NCT01962298|Other Pre-specified|Centroid Frequency of the EMG, as Trend Variability (Change in %) From First to Last Recording||From the start of spontaneous breathing till extubation, limited to maximum one hour after the onset of spontaneous breathing|||||||
2619599|NCT01962298|Secondary|Electric Activity of the Intercostal Muscles||From the start of spontaneous breathing till extubation, limited to maximum ten minutes after the onset of spontaneous breathing||||microvolt||Inter-Quartile Range|Median
2619600|NCT01962298|Primary|Electric Activity of the Diaphragm (Microvolts)||From the start of spontaneous breathing till extubation, limited to maximum ten minutes after the onset of spontaneous breathing||||microvolt||Inter-Quartile Range|Median
2619601|NCT01962207|Secondary|Booster Phase: Percentage of Participants With New Onset Chronic Illness Up to 6 Months Post Booster Vaccination|New onset chronic illness included autoimmune disorders, asthma, type I diabetes, allergies.|Up to 6 months post booster vaccination|Analysis population included all participants who received a booster dose of study vaccine MenACWY-TT in the booster stage.|||percentage of participants|||Number
2619602|NCT01962207|Secondary|Booster Phase: Percentage of Participants With Serious Adverse Events (SAEs) Up to 6 Months Post Booster Vaccination|An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to 6 months post booster vaccination|Analysis population included all participants who received a booster dose of study vaccine MenACWY-TT in the booster stage.|||percentage of participants|||Number
2619603|NCT01962207|Secondary|Booster Phase: Percentage of Participants With Unsolicited Adverse Events up to 31 Days Post Booster Vaccination|An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Up to 31 days post booster vaccination|Analysis population included all participants who received a booster dose of study vaccine MenACWY-TT in the booster stage.|||percentage of participants|||Number
2619604|NCT01962207|Secondary|Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination|Solicited general events: fatigue, gastrointestinal (GI) events (nausea, vomiting, diarrhea and/or abdominal pain, headache (0= normal, 1=mild/easily tolerated, 2=moderate/interfered with normal activity, 3=severe/prevented normal activity) and fever (>=37.5°C for oral/axillary/tympanic route, >=38.0°C for rectal route). Solicited local events: pain (0=none, 1=mild, not interfered/prevented normal activity, 2=moderate, painful when limb moved/interfered with normal activity, 3=severe, significant pain at rest/prevented normal activity), redness and swelling at injection site (record greatest surface diameter in millimeter (mm) as 0 to <=20 mm, >20 to <=50 mm, >50 mm). Participants may be represented in more than 1 category. Only categories with at least 1 participant reported. 'Medical advice' signifies medical advice received to resolve any event. 'Related'=relationship to study vaccine assessed by investigator.|Up to 4 days post booster vaccination|Analysis population included all participants who received a booster dose of study vaccine MenACWY-TT in the booster stage. “Number analyzed”: participants analyzed for specified category.|||percentage of participants|||Number
2619605|NCT01962207|Secondary|Persistence Phase: Percentage of Participants With Serious Adverse Events (SAEs) Related to Vaccination or Any Adverse Event (AE) Related to Lack of Vaccine Efficacy|"An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs related to lack of vaccine efficacy were as judged by the investigator."|Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination)|All the participants enrolled in the study.|||percentage of participants|||Number
2619606|NCT01962207|Secondary|Booster Phase: Percentage of Participants With hSBA Booster Response at 1 Month After Booster Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY. hSBA booster response to meningococcal antigens (A,C, W-135 and Y) is defined as: hSBA antibody titer >= 1:8 one month after vaccination, and at least 4-fold increase in hSBA titers one month after vaccination.|1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)|All eligible participants: received primary vaccination in study MenACWY-TT-027, booster vaccination in study MenACWY-TT-100, had available assay results for 1 month post booster vaccination blood sample. “N”: number of participants evaluable for this measure. “Number analyzed”: participants analyzed for specified serogroup.|||percentage of participants||95% Confidence Interval|Number
2619607|NCT01962207|Secondary|Booster Phase: Geometric Mean Titers Using hSBA For Each of the 4 Serogroups at 1 Month After Booster Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)|All eligible participants: received primary vaccination in study MenACWY-TT-027, booster vaccination in study MenACWY-TT-100, had available assay results for 1 month post booster vaccination blood sample. “N”: number of participants evaluable for this measure. “Number analyzed”: participants analyzed for specified serogroup titers cut off.|||titers||95% Confidence Interval|Geometric Mean
2619637|NCT01962103|Secondary|Phase 1: Volume of Distribution (Vss)||Cycle 1 Day 1 (Participants ≥ 6 years: 1-2 minutes prior to the end of infusion [EOI], and 15 minutes, 1, 3, 5, 8, 24, 48, and 72 hours after the EOI. Participants <6 years: 1-2 minutes prior to the EOI, and 15 minutes, 3, 5, and 24 hours after the EOI.)|PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data.|||liters||Geometric Coefficient of Variation|Geometric Mean
2619608|NCT01962207|Secondary|Booster Phase: Percentage of Participants With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)|All eligible participants: received primary vaccination in study MenACWY-TT-027, booster vaccination in study MenACWY-TT-100, had available assay results for 1 month post booster vaccination blood sample. “N”: number of participants evaluable for this measure. “Number analyzed”: participants analyzed for specified serogroup titers cut off.|||percentage of participants||95% Confidence Interval|Number
2619609|NCT01962207|Secondary|Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY. rSBA booster response to meningococcal antigens (A,C, W-135 and Y) is defined as: rSBA antibody titer >= 1:32 one month after vaccination, and at least 4-fold increase in rSBA titers one month after vaccination.|1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)|All eligible participants who received primary vaccination in study MenACWY-TT-027 and booster vaccination in this study (MenACWY-TT-100), had available assay results for 1 month post booster vaccination blood sample. “N”: number of participants evaluable for this measure. “Number analyzed”: participants analyzed for specified serogroup.|||percentage of participants||95% Confidence Interval|Number
2619610|NCT01962207|Secondary|Booster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)|All eligible participants who received primary vaccination in study MenACWY-TT-027 and booster vaccination in this study (MenACWY-TT-100) and had available assay results for the 1 month post booster vaccination blood sample. “N”: number of participants evaluable for this measure.|||titers||95% Confidence Interval|Geometric Mean
2619611|NCT01962207|Secondary|Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)|All eligible participants who received primary vaccination in study MenACWY-TT-027 and booster vaccination in MenACWY-TT-100, had available assay results for 1 month post booster vaccination blood sample. “N”: number of participants evaluable for this measure. “Number analyzed”: participants analyzed for specified serogroup titers cut off.|||percentage of participants||95% Confidence Interval|Number
2619612|NCT01962207|Secondary|Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100)|All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. “N”: number of participants evaluable for this measure. “Number analyzed”: participants analyzed for specified serogroup.|||titers||95% Confidence Interval|Geometric Mean
2619613|NCT01962207|Secondary|Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100)|All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. “N”: number of participants evaluable for this measure. “Number analyzed”: participants analyzed for specified serogroup titers cut off.|||percentage of participants||95% Confidence Interval|Number
2619614|NCT01962207|Primary|Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|10 years after primary vaccination (Year 5 of study MENACWY-TT-100)|All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. “N”: number of participants evaluable for this measure. “Number analyzed”: participants analyzed for specified serogroup.|||titers||95% Confidence Interval|Geometric Mean
2619615|NCT01962207|Primary|Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|9 years after primary vaccination (Year 4 of study MENACWY-TT-100)|All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. “N”: number of participants evaluable for this measure. “Number analyzed”: participants analyzed for specified serogroup.|||titers||95% Confidence Interval|Geometric Mean
2619616|NCT01962207|Primary|Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|8 years after primary vaccination (Year 3 of study MENACWY-TT-100)|All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. “N”: number of participants evaluable for this measure.|||titers||95% Confidence Interval|Geometric Mean
2619617|NCT01962207|Primary|Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|7 years after primary vaccination (Year 2 of study MENACWY-TT-100)|All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. “N”: number of participants evaluable for this measure. “Number analyzed”: participants analyzed for specified serogroup.|||titers||95% Confidence Interval|Geometric Mean
2619618|NCT01962207|Primary|Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|6 Years after primary vaccination (Year 1 of study MENACWY-TT-100)|All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027 and had available assay results for at least 1 tested antigen. “N”: number of participants evaluable for this measure.|||titers||95% Confidence Interval|Geometric Mean
2619619|NCT01962207|Primary|Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|10 years after primary vaccination (Year 4 of study MENACWY-TT-100)|All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. “N”: number of participants evaluable for this measure. “Number analyzed”: participants analyzed for specified serogroup titers cut off.|||percentage of participants||95% Confidence Interval|Number
2619620|NCT01962207|Primary|Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|9 years after primary vaccination (Year 4 of study MENACWY-TT-100)|All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. “N”: number of participants evaluable for this measure. “Number analyzed”: participants analyzed for specified serogroup titers cut off.|||percentage of participants||95% Confidence Interval|Number
2619621|NCT01962207|Primary|Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|8 years after primary vaccination (Year 3 of study MENACWY-TT-100)|All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027 and had available assay results for at least 1 tested antigen. “N”: number of participants evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2619622|NCT01962207|Primary|Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|7 years after primary vaccination (Year 2 of study MENACWY-TT-100)|All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. “N”: number of participants evaluable for this measure. “Number analyzed”: participants analyzed for specified serogroup titers cut off.|||percentage of participants||95% Confidence Interval|Number
2619623|NCT01962207|Primary|Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination|Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY).|6 years after primary vaccination (Year 1 of study MENACWY-TT-100)|All eligible participants who received primary vaccination with MenACWY-TT, Meningitec, or Mencevax ACWY during study MenACWY-TT-027 and had available assay results for at least 1 tested antigen. Here, “Overall Number of Participants Analyzed” (N) signifies number of participants evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2619624|NCT01962103|Secondary|Phase 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An AE was defined as any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A SAE is any AE occurring at any dose that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAEs were defined as AEs that began or worsened in severity on or after the date of the first dose of study drug and within 28 days of the date of the last dose of study drug. The severity of the AEs was graded according to the Common Terminology Criteria for Adverse Events, Version 4.0. Participants were followed for 28 days after discontinuing treatment for safety and monitoring of AEs.|Median treatment duration in Phase 2 per group: Ewings Sarcoma = 14 weeks (3-31), Neuroblastoma = 7 weeks (3-23), Rhabdomyosarcoma = 5 weeks (1-13). Participants were followed for 28 days after discontinuing treatment for safety and monitoring of AEs.|Safety Population: all participants who took at least 1 dose of study drug.|||Participants|||Count of Participants
2619625|NCT01962103|Secondary|Phase 2: Kaplan-Meier Estimate of Overall Survival Rate at 1 Year|Overall survival was defined as the time from the first dose date to date of death (any cause). Participants who were alive were censored at the last known time that the participant was alive.|1 year|Efficacy Evaluable Population: participants who met eligibility criteria for Phase 2, completed ≥1 dose of study drug, and had baseline and ≥1 postbaseline efficacy assessment if having not discontinued the investigational product prior to postbaseline efficacy assessment due to disease progression or systematic deterioration.|||percentage of participants||95% Confidence Interval|Number
2619626|NCT01962103|Secondary|Phase 2: Progression-Free Survival (PFS)|PFS was defined as the time from the first dose date to the start of disease progression or participant death (any cause), whichever occurred first. Disease progression was classed as either a disease progression observed as a response assessment, or a disease progression or symptomatic deterioration at treatment/study discontinuation. Participants who did not have disease progression or had not died were censored at the last known time that the participant was progression free. Disease progression was considered according to RECIST version 1.1 for Phase 2 Ewing's sarcoma and rhabdomyosarcoma participants. (For Phase 2 neuroblastoma participants who had both RECIST 1.1 and Curie score tumor evaluations, both tumor responses results were considered and an overall response was derived.) Median PFS time was estimated through Kaplan-Meier methods. 95% confidence interval about the median time to PFS event was obtained using Greenwood's method.|Median treatment duration in Phase 2 per group: Ewings Sarcoma = 14 weeks (3-31), Neuroblastoma = 7 weeks (3-23), Rhabdomyosarcoma = 5 weeks (1-13). Participants were followed until disease progression (if applicable) up to a maximum of 100.3 weeks.|Efficacy Evaluable Population: participants who met eligibility criteria for Phase 2, completed at least 1 dose of study drug, and had baseline and at least 1 postbaseline efficacy assessment if having not discontinued the investigational product prior to postbaseline efficacy assessment due to disease progression or systematic deterioration.|||weeks||95% Confidence Interval|Median
2619681|NCT01961323|Primary|Improvement in Exercise Tolerance|measured by stress echocardiogram, number of participants who had improvement in METS and improvement in exercise time as compared to their baseline.|at 6 months|Study results only for those who completed the study|||Participants|||Count of Participants
2619627|NCT01962103|Secondary|Phase 2: Disease Control Rate (DCR)|Disease control rate was defined as the percentage of participants who achieved either a stable disease maintained for ≥ 16 weeks or confirmed CR (confirmed no less than 4 weeks after criteria for response were first met) or confirmed PR (confirmed no less than 4 weeks after criteria for response were first met) over the total number of participants available for the analysis. Confidence interval was obtained using the Clopper-Pearson method.|Median treatment duration in Phase 2 per group: Ewings Sarcoma = 14 weeks (3-31), Neuroblastoma = 7 weeks (3-23), Rhabdomyosarcoma = 5 weeks (1-13).|Efficacy Evaluable Population: participants who met eligibility criteria for Phase 2, completed at least 1 dose of study drug, and had baseline and at least 1 postbaseline efficacy assessment if having not discontinued the investigational product prior to postbaseline efficacy assessment due to disease progression or systematic deterioration.|||percentage of participants||95% Confidence Interval|Number
2619628|NCT01962103|Secondary|Phase 2: Duration of Response (DOR)|Duration of response was defined as the time from the date of the first response (CR/PR, using RECIST version 1.1 guidelines) to disease progression for participants with a confirmed CR or PR. Participants who did not have disease progression or had not died were censored at the time of their last disease assessment or at time of start of new anticancer therapy, whichever occurred first. (For Phase 2 neuroblastoma patients who had both RECIST version 1.1 and Curie Score tumor evaluations, both tumor responses results were considered and an overall response was derived.)|Median treatment duration in Phase 2 per group: Ewings Sarcoma = 14 weeks (3-31), Neuroblastoma = 7 weeks (3-23), Rhabdomyosarcoma = 5 weeks (1-13). Participants were followed until disease progression (if applicable) up to a maximum of 100.3 weeks.|Efficacy Evaluable Population: participants (with response) who met eligibility criteria for Phase 2, completed ≥ 1 dose of study drug, and had baseline and ≥ 1 postbaseline efficacy assessment if having not discontinued the investigational product prior to postbaseline efficacy assessment due to disease progression or systematic deterioration.|||weeks||Full Range|Median
2619629|NCT01962103|Secondary|Phase 1 and 2 Population PK: Volume of Distribution of the Second Peripheral Compartment (V3)|Population PK analysis was performed using nonlinear mixed effect modeling. The estimated allometric function for V3 was 0.888.|Cycle 1 Day 1 (Participants ≥ 6 years: 1-2 minutes prior to the end of infusion [EOI], and 15 minutes, 1, 3, 5, 8, 24, 48, and 72 hours after the EOI. Participants < 6 years: 1-2 minutes prior to the EOI, and 15 minutes, 3, 5, and 24 hours after the EOI.)|PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data.|||liters|||Number
2619630|NCT01962103|Secondary|Phase 1 and 2 Population PK: Volume of Distribution of the First Peripheral Compartment (V2)|Population PK analysis was performed using nonlinear mixed effect modeling. The estimated allometric function for V2 was 0.888.|Cycle 1 Day 1 (Participants ≥ 6 years: 1-2 minutes prior to the end of infusion [EOI], and 15 minutes, 1, 3, 5, 8, 24, 48, and 72 hours after the EOI. Participants < 6 years: 1-2 minutes prior to the EOI, and 15 minutes, 3, 5, and 24 hours after the EOI.)|PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data.|||liters|||Number
2619631|NCT01962103|Secondary|Phase 1 and 2 Population PK: Intercompartmental CL Between the Central Compartment and the Second Peripheral Compartment (Q3)|Population PK analysis was performed using nonlinear mixed effect modeling. The estimated allometric function for Q3 was 1.12.|Cycle 1 Day 1 (Participants ≥ 6 years: 1-2 minutes prior to the end of infusion [EOI], and 15 minutes, 1, 3, 5, 8, 24, 48, and 72 hours after the EOI. Participants < 6 years: 1-2 minutes prior to the EOI, and 15 minutes, 3, 5, and 24 hours after the EOI.)|PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data.|||L/h|||Number
2619632|NCT01962103|Secondary|Phase 1 and 2 Population PK: Intercompartmental CL Between the Central Compartment and the First Peripheral Compartment (Q2)|Population PK analysis was performed using nonlinear mixed effect modeling. The estimated allometric function for Q2 was 1.12.|Cycle 1 Day 1 (Participants ≥ 6 years: 1-2 minutes prior to the end of infusion [EOI], and 15 minutes, 1, 3, 5, 8, 24, 48, and 72 hours after the EOI. Participants < 6 years: 1-2 minutes prior to the EOI, and 15 minutes, 3, 5, and 24 hours after the EOI.)|PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data.|||L/h|||Number
2619633|NCT01962103|Secondary|Phase 1 and 2 Population PK: Concentration in the Central Compartment at 50% of VMEL (KMEL)|Population PK analysis was performed using nonlinear mixed effect modeling.|Cycle 1 Day 1 (Participants ≥ 6 years: 1-2 minutes prior to the end of infusion [EOI], and 15 minutes, 1, 3, 5, 8, 24, 48, and 72 hours after the EOI. Participants < 6 years: 1-2 minutes prior to the EOI, and 15 minutes, 3, 5, and 24 hours after the EOI.)|PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data|||μg/L|||Number
2619634|NCT01962103|Secondary|Phase 1 and 2 Population PK: Maximum Elimination Rate From the Central Compartment (VMEL)|Population PK analysis was performed using nonlinear mixed effect modeling. The estimated allometric function for VMEL was 1.12.|Cycle 1 Day 1 (Participants ≥ 6 years: 1-2 minutes prior to the end of infusion [EOI], and 15 minutes, 1, 3, 5, 8, 24, 48, and 72 hours after the EOI. Participants < 6 years: 1-2 minutes prior to the EOI, and 15 minutes, 3, 5, and 24 hours after the EOI.)|PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data|||μg/h|||Number
2619635|NCT01962103|Secondary|Phase 1 and 2 Population PK: Volume of Distribution of the Central Compartment (V1)|Population PK analysis was performed using nonlinear mixed effect modeling. The estimated allometric function for V1 was 0.888.|Cycle 1 Day 1 (Participants ≥ 6 years: 1-2 minutes prior to the end of infusion [EOI], and 15 minutes, 1, 3, 5, 8, 24, 48, and 72 hours after the EOI. Participants < 6 years: 1-2 minutes prior to the EOI, and 15 minutes, 3, 5, and 24 hours after the EOI.)|PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data.|||liters|||Number
2619636|NCT01962103|Secondary|Phase 1: Vss - BSA-Normalized||Cycle 1 Day 1 (Participants ≥ 6 years: 1-2 minutes prior to the end of infusion [EOI], and 15 minutes, 1, 3, 5, 8, 24, 48, and 72 hours after the EOI. Participants <6 years: 1-2 minutes prior to the EOI, and 15 minutes, 3, 5, and 24 hours after the EOI.)|PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data.|||L/m^2||Geometric Coefficient of Variation|Geometric Mean
2619682|NCT01961297|Secondary|Voice Tremor Severity|Visual analog scale of severity (0 for none, 100 for most severe/profound)|baseline and Day 1|Only alcohol-responsive participants with voice tremors were included in analysis|||units on a scale||Standard Deviation|Mean
2619638|NCT01962103|Secondary|Phase 1: CL - Body Surface Area (BSA)-Normalized|Measurement of renal clearance from the body.|Cycle 1 Day 1 (Participants ≥ 6 years: 1-2 minutes prior to the end of infusion [EOI], and 15 minutes, 1, 3, 5, 8, 24, 48, and 72 hours after the EOI. Participants <6 years: 1-2 minutes prior to the EOI, and 15 minutes, 3, 5, and 24 hours after the EOI.)|PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data.|||L/h/m^2||Geometric Coefficient of Variation|Geometric Mean
2619639|NCT01962103|Secondary|Phase 1: Clearance (CL)|Measurement of renal clearance from the body.|Cycle 1 Day 1 (Participants ≥ 6 years: 1-2 minutes prior to the end of infusion [EOI], and 15 minutes, 1, 3, 5, 8, 24, 48, and 72 hours after the EOI. Participants <6 years: 1-2 minutes prior to the EOI, and 15 minutes, 3, 5, and 24 hours after the EOI.)|PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2619640|NCT01962103|Secondary|Phase 1: AUC - Dose-Normalized|Measurements include: AUC24 and AUCinf.|Cycle 1 Day 1 (Participants ≥ 6 years: 1-2 minutes prior to the end of infusion [EOI], and 15 minutes, 1, 3, 5, 8, 24, 48, and 72 hours after the EOI. Participants <6 years: 1-2 minutes prior to the EOI, and 15 minutes, 3, 5, and 24 hours after the EOI.)|PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data for given measure.|||ng*h/mL/[mg]||Geometric Coefficient of Variation|Geometric Mean
2619641|NCT01962103|Secondary|Phase 1: Area Under the Plasma Concentration-Time Curve (AUC)|Measurements include: AUC from time zero to the last measurable concentration (AUCt), AUC from time zero to 24 hours (AUC24), and AUC from time zero to infinity (AUCinf).|Cycle 1 Day 1 (Participants ≥ 6 years: 1-2 minutes prior to the end of infusion [EOI], and 15 minutes, 1, 3, 5, 8, 24, 48, and 72 hours after the EOI. Participants <6 years: 1-2 minutes prior to the EOI, and 15 minutes, 3, 5, and 24 hours after the EOI.)|PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data for given measure.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2619642|NCT01962103|Secondary|Phase 1: Cmax - Dose-Normalized||Cycle 1 Day 1 (Participants ≥ 6 years: 1-2 minutes prior to the end of infusion [EOI], and 15 minutes, 1, 3, 5, 8, 24, 48, and 72 hours after the EOI. Participants <6 years: 1-2 minutes prior to the EOI, and 15 minutes, 3, 5, and 24 hours after the EOI.)|PK population: all participants who received at least one dose of nab-paclitaxel and had evaluable concentration data.|||ng/mL/[mg]||Geometric Coefficient of Variation|Geometric Mean
2619643|NCT01962103|Secondary|Phase 1: Maximum Observed Concentration of Paclitaxel in Blood Plasma (Cmax)||Cycle 1 Day 1 (Participants ≥ 6 years: 1-2 minutes prior to the end of infusion [EOI], and 15 minutes, 1, 3, 5, 8, 24, 48, and 72 hours after the EOI. Participants <6 years: 1-2 minutes prior to the EOI, and 15 minutes, 3, 5, and 24 hours after the EOI.)|Pharmacokinetic (PK) population: all participannts who received at least one dose of nab-paclitaxel and had evaluable concentration data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2619644|NCT01962103|Secondary|Phase 1: ORR|Overall response rate was defined as the percentage of participants who achieved a complete response (CR; disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) confirmed no less than 4 weeks after the criteria for response were first met) using RECIST version 1.1 guidelines over the total number of participants available for the analysis. Confidence interval was obtained using the Clopper-Pearson method.|Median treatment duration in Phase 1 was 7.0 weeks, with minimum and maximum duration of 1 and 49 weeks, respectively.|Efficacy Evaluable Population: participants who met eligibility criteria for Phase 1, completed at least 1 dose of study drug, and had baseline and at least 1 postbaseline efficacy assessment if having not discontinued the investigational product prior to postbaseline efficacy assessment due to disease progression or systematic deterioration.|||percentage of participants||95% Confidence Interval|Number
2619645|NCT01962103|Primary|Phase 2: Overall Response Rate (ORR)|Overall response rate was defined as the percentage of participants who achieved a complete response (CR; disappearance of all target lesions) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) confirmed no less than 4 weeks after the criteria for response were first met using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. (For Phase 2 neuroblastoma participants who had both RECIST and Curie Score tumor evaluations, both tumor response results were considered and an overall response was derived.) Confidence interval was obtained using the Clopper-Pearson method.|Median treatment duration in Phase 2 per group: Ewings Sarcoma = 14 weeks (3-31), Neuroblastoma = 7 weeks (3-23), Rhabdomyosarcoma = 5 weeks (1-13).|Efficacy Evaluable Population: participants who met eligibility criteria for Phase 2, completed at least 1 dose of study drug, and had baseline and at least 1 postbaseline efficacy assessment if having not discontinued the investigational product prior to postbaseline efficacy assessment due to disease progression or systematic deterioration.|||percentage of participants||95% Confidence Interval|Number
2619646|NCT01962103|Primary|Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was defined as any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE (SAE) is any AE occurring at any dose that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. TEAEs were defined as AEs that began or worsened in severity on or after the date of the first dose of study drug and within 28 days of the date of the last dose of study drug. The severity of an AE was graded according to the CTCAE, Version 4.0.|Median treatment duration in Phase 1 was 7.0 weeks, with minimum and maximum duration of 1 and 49 weeks, respectively. Participants were followed for 28 days after discontinuing treatment for safety and monitoring of AEs.|Safety Population: all participants who took at least 1 dose of study drug.|||Participants|||Count of Participants
2619683|NCT01961297|Secondary|Breathlessness Severity|Visual analog scale of severity (0 for none, 100 for most severe/profound)|baseline and Day 1|Only alcohol-responsive participants were included in analysis|||units on a scale||Standard Deviation|Mean
2619684|NCT01961297|Secondary|Voice Harshness Severity|Visual analog scale of severity (0 for none, 100 for most severe/profound)|baseline and Day 1|Only alcohol-responsive participants were included in analysis|||units on a scale||Standard Deviation|Mean
2619647|NCT01962103|Primary|Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)|"A DLT was defined as investigational product (IP)-related adverse events occurring during the DLT assessment period that led to treatment discontinuation or met one of the following criteria: - Common Terminology Criteria for Adverse Events (CTCAE) Grade (Gr) 3 or 4 nonhematologic toxicity (excluding transient transaminitis) - CTCAE Gr 3 or 4 nausea or vomiting that persisted > 5 days despite maximal anti-emetic treatment - CTCAE Gr 4 thrombocytopenia or anemia that persisted > 7 days or required transfusion > 7 days - CTCAE Gr 3 thrombocytopenia with bleeding - CTCAE Gr 4 uncomplicated neutropenia lasting > 7 days - Febrile neutropenia with confirmed bacterial infection - CTCAE Gr 3 hematologic toxicity requiring treatment (tx) delay > 21 days. Use of ... in the table rows signifies the continuation of row title per the above list."|DLT assessment period: For participants > 10 kg: the first 28-day cycle including Cycle 2 Day 1 predose evaluations; for participants ≤ 10 kg: the first two 28-day cycles including Cycle 3 Day 1 predose evaluations|Dose Determining Set (DDS): all Phase 1 participants who received all 3 weekly doses of nab-paclitaxel at the cohort planned dose during Cycle 1 and had adequate safety assessments during the DLT assessment period or experienced a DLT. The DDS did not include participants who were enrolled at each dose once the dose had been determined to be safe.|||Participants|||Count of Participants
2619648|NCT01961921|Secondary|Change From Baseline in Nutritional Status (Modified Body Mass Index, mBMI)|Nutritional status of patients was evaluated using the mBMI, calculated as BMI (kg/m^2) multiplied by albumin (g/L). An increase from baseline in mBMI suggests improvement, and a decrease from baseline suggests worsening.|Baseline, Month 24|Full Analysis Set: All participants who were enrolled were included in the full analysis set. The number of participants analyzed is the number for whom evaluable data were available.|||kg/m^2 x albumin g/L||Full Range|Median
2619649|NCT01961921|Secondary|Mean Change From Baseline in Hand Grip Strength|The mean (SEM) hand grip strength change from baseline at 24 months between patients who used patisiran with or without a concomitant TTR stabilizer.|Baseline, Month 24|Full Analysis Set: All participants who were enrolled were included in the full analysis set. The number of participants analyzed is the number for whom evaluable data were available.|||kg||Full Range|Median
2619650|NCT01961921|Secondary|Change in Gait Speed With 10-meter Walk Test|The 10-meter walk test measures the time (in seconds) that it takes a patient to walk 10 meters.|Baseline, Month 24|Full Analysis Set: All participants who were enrolled were included in the full analysis set. The number of participants analyzed is the number for whom evaluable data were available.|||m/sec||Full Range|Median
2619651|NCT01961921|Secondary|Change From Baseline in Quality of Life and Disability as Assessed by the EuroQoL (Quality of Life)-5 Dimensions (EQ-5D), EuroQoL Visual Analog Scale (EQ-VAS) Questionnaires and Rasch-built Overall Disability Scale (R-ODS)|The overall EQ-5D is measured on a scale from 0 to 1, with 0 being worst and 1 best. The EQ-VAS is measured on a scale of 0-100, with 0 being the worst and 100 the best. The R-ODS captures activity and social participation limitations in patients. The R-ODS score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).|Baseline, Month 24|Full Analysis Set: All participants who were enrolled were included in the full analysis set. The number of participants analyzed is the number for whom evaluable data were available.|||Score on a scale||Full Range|Median
2619652|NCT01961921|Secondary|Change From Baseline in the Modified Neuropathy Impairment Score +7 (mNIS+7)|The mNIS+7 assessment is a composite measure of neurologic impairment that provides a comprehensive measure of large and small fiber function that encompasses the totality of the motor, sensory, and autonomic deficits seen in hereditary transthyretin-mediated amyloidosis (hATTR) patients with polyneuropathy. The minimum and maximum values are 0 and 304, respectively. A higher score indicates a worse outcome.|Baseline, Month 24|Full Analysis Set: All participants who were enrolled were included in the full analysis set. The number of participants analyzed is the number for whom evaluable data were available.|||score on a scale||Full Range|Median
2619653|NCT01961921|Secondary|Percentage Change From Baseline in Serum TTR Levels|TTR levels, measured using the enzyme-linked immunosorbent assay (ELISA) method.|From Baseline up to 56 days post last dose|Full Analysis Set: All participants who were enrolled were included in the full analysis set.|||Percent Change||Standard Error|Mean
2619654|NCT01961921|Primary|The Number of Participants Experiencing Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Drug Discontinuation|An AE is any untoward medical occurrence in a patient or clinical investigational patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.|From Baseline up to 56 days post last dose|Safety Analysis Set: All participants who received at least one dose of study drug.|||participants|||Number
2619655|NCT01961609|Secondary|Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 2 Period|The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score.|Baseline, 48 and 72 weeks|The full analysis set was considered for the analysis. Only participants with measurements at each given time point were analyzed for that time point.|||percent change||Standard Deviation|Mean
2619656|NCT01961609|Secondary|Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Maintenance 1 Period|The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score.|Baseline, 16, 24 and 48 weeks|The full analysis set was considered for the analysis. Only participants with measurements at each given time point were analyzed for that time point.|||percent change||Standard Deviation|Mean
2619685|NCT01961297|Secondary|Number of Voice Breaks|The number of SD-characteristic voice breaks in each sentence at pre-drug and post-drug assessment|baseline and Day 1|Only alcohol-responsive participants were included in analysis|||voice breaks||Standard Deviation|Mean
2619657|NCT01961609|Secondary|Mean Percent Change in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment Scores (From 0 to 100) - Initiation Period|The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score.|Baseline, 12 and 16 weeks|The full analysis set was considered for the analysis. Only participants with measurements at each given time point were analyzed for that time point.|||percent change||Standard Deviation|Mean
2619658|NCT01961609|Secondary|Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 2 Period|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change from baseline indicates improvement."|Baseline, 48 and 72 weeks|The full analysis set was considered for the analysis. Only participants who had both baseline and post baseline measurements for a given time point were analyzed for that time point.|||score on a scale||Standard Deviation|Mean
2619659|NCT01961609|Secondary|Mean Change From Baseline in Dermatology Life Quality Index (DLQI)Total Scores - Maintenance 1 Period|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change from baseline indicates improvement."|Baseline, 16, 24 and 48 weeks|The full analysis set was considered for the analysis. Only participants who had both baseline and post baseline measurements for a given time point were analyzed for that time point.|||score on a scale||Standard Deviation|Mean
2619660|NCT01961609|Secondary|Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Total Scores - Initiation Period|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative change from baseline indicates improvement."|Baseline, week 12, and week 16|The full analysis set was considered for the analysis. Only participants who had both baseline and post baseline measurements for a given time point were analyzed for that time point.|||score on a scale||Standard Deviation|Mean
2619661|NCT01961609|Secondary|Percentage of Participants Achieving NICE Continuation Criteria (PASI 75 or PASI 50 Plus a 5 Point Improvement in DLQI) at 16 Weeks|PASI 75 is defined as participants achieving ≥ 75% improvement from baseline. The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases. The measure is widely used: it has been tested across 32 different skin conditions and is available in 55 languages. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.|16 Weeks|The full analysis set was analyzed.|||Percentage of participants|||Number
2619662|NCT01961609|Secondary|Percentage of Participants Who Have Failed on One Anti-TNFα Achieving PASI 75 (Subgroups 1 and 2 Combined) at 16 Weeks|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline.|16 Weeks|The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).|||Percentage of participants|||Number
2619663|NCT01961609|Secondary|Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 2 Period|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively.|48 and 72 Weeks|The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).|||Percentage of participants|||Number
2620708|NCT01953224|Other Pre-specified|Number of Participants Who Drop Out of the Study From Baseline to 12 Weeks|We will investigate the number of participants who drop out of the intervention group in comparison to the control group and to norms for similar studies|12 weeks|||||||
2619664|NCT01961609|Secondary|Percentage of Participants Achieving PASI 50 and PASI 90 - Maintenance 1 Period|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively.|16, 24 and 48 Weeks|The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).|||Percentage of participants|||Number
2619665|NCT01961609|Secondary|Percentage of Participants Achieving PASI 50 and PASI 90 - Initiation Period|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50 and PASI 90 are defined as participants achieving ≥ 50% and ≥ 90% improvement from baseline, respectively.|2, 4, 8, 12, 16 Weeks|The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).|||Percentage of participants|||Number
2619666|NCT01961609|Secondary|Percentage of Participants Achieiving PASI 75 - Maintenance 2 Period|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline.|48 and 72 Weeks|The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).|||Percentage of participants|||Number
2619667|NCT01961609|Secondary|Percentage of Participants Achieiving PASI 75 - Maintenance 1 Period|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline.|16, 24 and 48 Weeks|The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).|||Percentage of participants|||Number
2619668|NCT01961609|Secondary|Percentage of Participants Achieiving PASI 75 - Initiation Period|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline.|2 ,4, 8, 12 and 16 Weeks|The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).|||Percentage of participants|||Number
2619669|NCT01961609|Secondary|Percentage of Participants Achieving PASI 75 According to 3 Key Participant Subgroups (Primary Inadequate Response (IR), Secondary IR and IR After More Than One Anti-TNFalpha Therapies) at 16 Weeks|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline.|16 Weeks|The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).|||Percentage of participants|||Number
2619686|NCT01961297|Primary|Number of Participants Who Reported Positive Effects.|Number of participants who had reported positive effects of at least one alcohol drink on their voice symptoms|Day 1|Only alcohol-responsive participants were in this analysis which is 23 from the SD group and 22 from the SD/VT group.|||Participants|||Count of Participants
2619687|NCT01961271|Secondary|Secondary Efficacy Outcome -- Incidence of Early Treatment Discontinuation Due to Lack of Efficacy.||From time of enrolment to Visit 6 (ie. up to119 days from enrolment)||||participants|||Number
2619708|NCT01961167|Secondary|Change in Functional Status - EQ5D- Mobility|Change in functional status (EQ5D - Mobility) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.|6 Months|Patient population includes subjects followed for at least 150 days and had relevant data.|||Participants|||Count of Participants
2619670|NCT01961609|Secondary|Percentage of Secukinumab 150 mg Participants Achieving PASI 75 at 16 Weeks|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline.|16 Weeks|The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).|||Percentage of participants|||Number
2619671|NCT01961609|Primary|Percentage of Secukinumab 300 mg Participants Achieving PASI 75 at 16 Weeks|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs); each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 is defined as participants achieving ≥ 75% improvement from baseline.|16 weeks|The full analysis set was analyzed. Missing values with respect to response variables based on PASI score have been imputed with non-response throughout regardless of the reason for missing data (e.g. premature study discontinuation, missed visit, administrative issues).|||Percentage of participants|||Number
2619672|NCT01961544|Secondary|Disease Control Rate (DCR)|DCR is defined as the number of participants with complete response (CR), partial response (PR), and stable disease (SD). The Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used to assess the tumor response. Tumor response was evaluated by investigators. CR is defined as the disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to <10 millimeters (mm) in the short axis. PR is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (SLD increased by at least 20% from the smallest value on study [including baseline, if that is the smallest]. The SLD must also demonstrate an absolute increase of at least 5 mm. [Two lesions increasing from 2 mm to 3 mm, for example, does not qualify]).|mean of 3.76 months|Full Analysis Set: participants who were administered investigational product at least once after enrollment and had at least one primary efficacy data value since Baseline|||Participants|||Number
2619673|NCT01961544|Primary|Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-emergent Serious Adverse Event (SAE)|An AE is defined as any harmful, untoward sign (including abnormal laboratory value, etc.), symptom, or disease in a participant administered investigational product that does not necessarily have a causal relationship with treatment. An SAE is defined as an AE that is life threatening or results in death, results in hospitalization (initial or prolonged), results in a disability (significant, persistent, or permanent change, impairment, damage or disruption in the participant's body function/structure, physical activities, or quality of life), results in a congenital anomaly, or requires intervention to prevent permanent impairment or damage. TEAEs are defined as those events that started on or after the date and time of administration of the first dose of study drug and those events that were present prior to the administration of the first dose of study drug and increased in severity during the study.|mean of 3.76 months|Safety Set: all participants who are administered investigational product at least once for the analysis|||Participants|||Number
2619674|NCT01961362|Secondary|Fatigue Severity Scale|The Fatigue Severity Scale is a 9-item questionnaire, scored from 9-63, with higher scores indicating more severe fatigue.|One month after daily-use supplemental oxygen implementation||||units on a scale||Standard Error|Mean
2619675|NCT01961362|Secondary|Change in Physical Component Summary (PCS) Score From the Medical Outcomes Study Short-Form, 36-item Questionnaire (SF-36).|The PCS of the SF-36 assesses a domain of quality of life. Its scores range from 0-100, with higher scores indicating better quality of life on this domain.|One month after daily-use supplemental oxygen implementation||||units on a scale||Standard Error|Mean
2619676|NCT01961362|Primary|Change in University of California San Diego Shortness of Breath Questionnaire From Immediately Prior to One Month After Starting Daily-use Supplemental Oxygen|"The University of California San Diego Shortness of Breath Questionnaire (or UCSD SOB) is a tool that measures shortness of breath using 24 items, each with response options ranging from 0 to 5, corresponding to None at all and Maximally or unable to do because of breathlessness. Thus, scores for the UCSD SOB range from 0 to 120, with higher scores indicating greater shortness of breath."|UCSD SOB score at one month after being prescribed supplemental O2||||points||Standard Deviation|Mean
2619677|NCT01961349|Primary|Achivement of Target Sedation|The target sedation is defined as MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scores 2 to 4 for ≥50% of all MOAA/S measurements from scope-in to scope-out.|from scope-in to scope-out|FAS (Full Analysis Set)|||% of patients||95% Confidence Interval|Number
2619678|NCT01961349|Secondary|PSSI Total Score|PSSI (Statistics of Patient Satisfaction with Sedation Instrument) total score obtained from 20 questions (1 to 7 points for each) adjusted to have range of 0 ( very dissatisfied: all items scored with 1 point) to 100 (very satisfied: all items scored with 7 points)|at 24-48 h after endoscopy|FAS (Full Analysis Set)|||Score on a scale (0 - 100)||Standard Deviation|Mean
2619679|NCT01961323|Secondary|Untwist Rate of the Left Ventricle|measured as a part of stress echocardiogram, number of participants with significant improvement in the LV untwist after Nebivolol treatment in patients who completed the study|at 6 months||||Participants|||Count of Participants
2619680|NCT01961323|Secondary|E Velocity Indexed to e' (E/e' Ratio) of the Left Ventricle|measured as a part of stress echocardiogram, E/e' ratio: The normal E/e' ratio from the medial annulus is <8 and suggests a normal left atrial pressure. While values between 8 and 12 are indeterminate, a value >12 is indicative of an elevated left atrial pressure or PCWP (>18mmHg). The ranges for E/e' from the lateral mitral annulus are <5, 5 -10 and >10 respectively.|at 6 months|Results for the participants who had improved exercise capacity only (from Outcome Measure 1)|||ratio||Standard Deviation|Mean
2619688|NCT01961271|Secondary|Secondary Efficacy Outcome on Physicians' and Patients' Treatment Satisfaction Assessed Using Physician's Global Impression of Change Scale and Patient's Global Impression of Change Scale Respectively|"The overall assessment of the change in pain intensity from baseline is measured at Visit 6.~Physician's Global Impression of Change scale: Investigator's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse Patient's Global Impression of Change scale: Subject's opinion on a scale of 1 to 7 where 1 is very much improved and 7 is very much worse"|At visit 6 (anywhere between Day 91 to 119 after enrolment depending on how long titration took)||||units on a scale||Standard Deviation|Mean
2619689|NCT01961271|Secondary|Secondary Efficacy Outcome as Measured by Number of Subjects Requiring at Least 1 Breakthrough (Rescue) Pain Medication|Daily use of breakthrough pain medication from visits 1-6, assessed from patient diaries.|Approximately 17 weeks starting from enrolment||||participants|||Number
2619690|NCT01961271|Secondary|Treatment-emergent Adverse Events (TEAE's) as Measured by Number of Subjects With at Least 1 TEAE|Side effects of the transdermal patch treatment will be analysed.|From time of enrolment up to 7 days after completion / discontinuation visit (up to 140 days)||||participants|||Number
2619691|NCT01961271|Secondary|Secondary Efficacy Outcome Determined by Change in Percentage of Subjects Who Met Criteria on EQ5D-3L Quality of Life Questionnaire From Pre- to Post-intervention|"Pre-intervention: Visit 1 Post-intervention: Visit 6~There are 5 dimensions in the EQ5D-3L questionnaire answered by the subjects, classified into 5 categories here:~Mobility -- change in % of subjects who have no problem in walking around Self-care -- change in % of subjects who have no problem in self-care Usual activities -- change in % of subjects who have no problem with performing their usual activities Pain/ discomfort -- change in % of subjects who do not experience pain or discomfort Anxiety/ depression -- change in % of subjects who do not feel anxious or depressed"|approximately 17 weeks starting from enrolment||||percentage of subjects|||Number
2619692|NCT01961271|Primary|Efficacy According to BS-11 Pain Score Reduction|"The primary efficacy outcome analysis is the pre- and post-intervention change in BS-11 pain score. The reduction in scores were calculated by subtracting the post-intervention score from the baseline score.~BS-11 is known as Box scale-11; it is an 11-point scale measuring pain intensity. It ranges from 0 to 10, whereby 0 represents no pain and 10 represents the worst imaginable pain. Subjects selected a number based on the pain intensity they were feeling at that time."|Maximum 17 weeks starting from enrolment|Subjects of the analysis population met the eligibility criteria. It consists of subjects who completed the study and who withdrew for any reason.|||units on a scale||Standard Deviation|Mean
2619693|NCT01961167|Other Pre-specified|Freedom From Major Amputation of the Treated Leg(s)|Number of subjects experiencing a major amputation of the treated leg(s), resulting from a vascular event within 6 months - component|6 Months|Population includes subjects followed for at least 150 days.|||Participants|||Count of Participants
2619694|NCT01961167|Other Pre-specified|Freedom From Myocardial Infarction (MI)|Number of subjects experiencing a myocardial infarction (MI) within 30 days - component of primary outcome.|30 Days|Population includes subjects followed for at least 30 days.|||Participants|||Count of Participants
2619695|NCT01961167|Other Pre-specified|Device or Procedure-related Death|Number of subjects experiencing a device or procedure-related death within 30 days - component of primary outcome.|30 Days|Population includes subjects followed for at least 30 days.|||Participants|||Count of Participants
2619696|NCT01961167|Secondary|Number of Participants With Improvement in Differential Diagnoses at 180 Days - Walking Impairment Questionnaire (WIQ)|Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 180 days.|6 Months|Population includes subjects followed for at least 6 Months and had relevant data.|||Participants|||Count of Participants
2619697|NCT01961167|Secondary|Number of Participants With Improvement in Differential Diagnoses at 30 Days - Walking Impairment Questionnaire (WIQ)|Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.|30 day|Population includes subjects followed for at least 30 days and had relevant data.|||Participants|||Count of Participants
2619698|NCT01961167|Secondary|Change in Functional Status - EQ5D- Own Health State|Change in functional status (EQ5D - Own Health State) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.|6 Months|Population includes subjects followed for at least 150 days and had relevant data.|||Participants|||Count of Participants
2619699|NCT01961167|Secondary|Change in Functional Status - EQ5D- Own Health State|Change in functional status (EQ5D - Own Health State) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||Participants|||Count of Participants
2619700|NCT01961167|Secondary|Change in Functional Status - EQ5D - Anxiety/Depression|Change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.|6 Months|Population includes subjects followed for at least 150 days and had relevant data.|||Participants|||Count of Participants
2619701|NCT01961167|Secondary|Change in Functional Status - EQ5D - Anxiety/Depression|Change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||Participants|||Count of Participants
2619702|NCT01961167|Secondary|Change in Functional Status - EQ5D - Pain/Discomfort|Change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.|6 Months|Population includes subjects followed for at least 150 days and had relevant data.|||Participants|||Count of Participants
2619703|NCT01961167|Secondary|Change in Functional Status - EQ5D - Pain/Discomfort|Change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days. EQ5D is a standard instrument for use as a measure of health outcome.|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||Participants|||Count of Participants
2619704|NCT01961167|Secondary|Change in Functional Status - EQ5D - Usual Activities|Change in functional status (EQ5D - Usual Activities) from pre-procedure at 6 months. EQ5D is a standard instrument for use as a measure of health outcome.|6 Months|Population includes subjects followed for at least 150 days and had relevant data.|||Participants|||Count of Participants
2619710|NCT01961167|Secondary|Freedom From Major Adverse Events (MAEs)|Number of subjects experiencing freedom from procedure- or device-related events causing death, occurring within 30 days of the index procedure; and myocardial infarction (MI) occurring within 30 days of the index procedure; and target lesion revascularization (TLR) occurring within 6 months of the index procedure; and major amputation of the treated leg(s), resulting from a vascular event, occurring within 6 months of the index procedure.|6 months|Population includes number of subjects enrolled into the study who either had defined event or were followed for at least 150 days.|||Participants|||Count of Participants
2619711|NCT01961167|Secondary|Change in Ankle Brachial Index (ABI)|Change in Ankle Brachial Index(ABI) from pre-procedure at 6 months. Larger values indicate a better outcome.The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm|6 Months|Population includes subjects followed for at least 150 days and had relevant data.|||ratio|limbs|Full Range|Mean
2619712|NCT01961167|Secondary|Change in Ankle Brachial Index (ABI)|Change in Ankle Brachial Index (ABI) from pre-procedure at 30 days. Larger values indicate a better outcome. The ABI is the systolic pressure at the ankle, divided by the systolic pressure at the arm|30 Days|Population includes subjects followed for at least 23 days and had relevant data.|||ratio|limbs|Full Range|Mean
2619713|NCT01961167|Secondary|Number of Participants With Change in Rutherford Category|"Change in Rutherford Category from pre-procedure at 6 months.~Rutherford categories include:~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene"|6 Months|Population includes subjects followed for at least 150 days and had relevant data.|||Participants|||Count of Participants
2619714|NCT01961167|Secondary|Number of Participants With a Change in Rutherford Category|"Change in Rutherford Category from pre-procedure at 30 days.~Rutherford categories include:~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene"|30 Days|Population includes subjects followed for at least 23 days and had relevant data.|||Participants|||Count of Participants
2619715|NCT01961167|Secondary|Freedom From Target Vessel Revascularization (TVR)|Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 6 months. TVR is defined as revascularization of the vessel treated at the time of the index procedure by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.|6 Months|Population includes subjects followed for at least 180 days.|||percentage of vessel||95% Confidence Interval|Number
2619716|NCT01961167|Secondary|Freedom From Target Vessel Revascularization (TVR)|Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days. TVR is defined as revascularization of the vessel treated at the time of the index procedure by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.|30 Days|Population includes subjects followed for at least 30 days.|||Vessel||95% Confidence Interval|Number
2619717|NCT01961167|Secondary|Freedom From Target Lesion(s) Revascularization (TLR)|Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 6 months. TLR is defined as revascularization occurring within the treated segment(s) by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.|6 Months|Population includes subjects followed for at least 180 days.|||percentage of lesions||95% Confidence Interval|Number
2619718|NCT01961167|Secondary|Freedom From Target Lesion(s) Revascularization (TLR)|Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days. TLR is defined as revascularization occurring within the treated segment(s) by means of a percutaneous vascular intervention, surgical bypass, thrombolysis, or other invasive means.|30 Days|Population includes subjects followed for at least 30 days.|||percentage of lesions||95% Confidence Interval|Number
2619719|NCT01961167|Secondary|Secondary Patency|Kaplan-Meier estimate of secondary patency at 6 months. Secondary patency is defined as presence of blood flow, with or without reintervention, in the originally treated segment(s), including the proximal and distal margins.|6 Months|Population includes subjects followed for at least 180 days and had relevant data.|||percentage of lesions||95% Confidence Interval|Number
2619720|NCT01961167|Secondary|Secondary Patency|Kaplan-Meier estimate of secondary patency at 30 days. Secondary patency is defined as presence of blood flow, with or without reintervention, in the originally treated segment(s), including the proximal and distal margins.|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||percentage of lesions||95% Confidence Interval|Number
2619721|NCT01961167|Secondary|Primary Assisted Patency|Kaplan-Meier estimate of primary assisted patency at 6 Months. Primary assisted patency is defined as blood flow maintained with or without reintervention in the originally treated segment(s), including the proximal and distal margins.|6 Months|Population includes subjects followed for at least 180 days and had relevant data.|||Lesions||95% Confidence Interval|Number
2619722|NCT01961167|Secondary|Primary Assisted Patency|Kaplan-Meier estimate of primary assisted patency at 30 days. Primary assisted patency is defined as blood flow maintained with or without reintervention in the originally treated segment(s), including the proximal and distal margins.|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||percentage of lesions||95% Confidence Interval|Number
2619723|NCT01961167|Secondary|Primary Patency|Kaplan-Meier estimate of primary patency at 6 months. Primary patency is defined as blood flow in the treated segment(s), without reintervention.|6 Months|Population includes subjects followed for at least 180 days and had relevant data.|||percentage of lesions||95% Confidence Interval|Number
2619724|NCT01961167|Secondary|Primary Patency|Kaplan-Meier estimate of primary patency at 30 days. Primary patency is defined as blood flow in the treated segment(s), without reintervention.|30 Days|Analysis includes subjects followed for at least 30 days and had relevant data.|||percentage of lesions||95% Confidence Interval|Number
2620730|NCT01952691|Secondary|Adduction Angle|we aimed to see the change in hallux valgus angle during treatment.|baseline and 30th days.||||degrees|Participants|Standard Deviation|Mean
2619725|NCT01961167|Secondary|Thirty-day Clinical Success|"Number of subjects who experienced 30-day clinical success defined as an improvement of at least one Rutherford Category at the 30-day visit as compared to pre-procedure and no device- or procedure-related serious adverse events (SAEs) within 30 days of the index procedure.~Rutherford categories include:~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene"|30 Days|Population includes subjects followed for at least 30 days and had relevant data.|||Participants|||Count of Participants
2619726|NCT01961167|Secondary|Acute Procedural Success|Number of subjects who experience acute procedural success defined as less than or equal to 30% residual stenosis prior to procedure completion and no device- or procedure-related SAEs before discharge at day 1.|Discharge|Population includes subjects followed through discharge at day 1 and had relevant procedural data.|||Participants|||Count of Participants
2619727|NCT01961167|Primary|Composite of Major Adverse Events (MAEs)|"Percentage of study subjects experiencing a major adverse event (MAE) defined as:~Device- or procedure-related death within 30 days of the index procedure; and~Myocardial Infarction (MI) occurring within 30 days of the index procedure; and~Amputation above the metatarsals in the treated leg, resulting from a vascular event, occurring within 30 days of the index procedure."|30 days|Population includes enrolled subjects who either experienced the defined event or were followed for at least 30 days.|||percentage of subjects experiencing MAE||95% Confidence Interval|Number
2619728|NCT01961115|Secondary|Time to Tumor Progression Using RECIST or irRC_v2||Up to 1 year|Data were not collected||||||
2619729|NCT01961115|Secondary|Overall Survival_v2||From the time measurement criteria are met for complete response or partial response until the first date that recurrent and progressive disease is objectively documented, assessed up to 1 year|Data were not collected||||||
2619730|NCT01961115|Secondary|Overall Response Rate Using the RECIST or Immune-Related Response Criteria (irRC)_v2||Up to 1 year|Data were not collected||||||
2619731|NCT01961115|Secondary|Incidence of Adverse Events Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0_v2||Up to 1 year|Data were not collected||||||
2619732|NCT01961115|Secondary|Changes in the Level or Character of the Vaccine-induced CD8+ and CD4+ Specific T-cell Immune Responses by IFN-gamma ELISPOT_v2|Assessment of immunologic response will be based on a fold-increase measure from baseline as well as using a positivity threshold|Baseline to up to 16 weeks|Data were not collected||||||
2619733|NCT01961115|Secondary|Changes in Expression of IDO1 Protein by IHC in Tumor or Tumor-infiltrating Cells_v2||Baseline to up to 16 weeks|Data were not collected||||||
2619734|NCT01961115|Secondary|Change in the Number and Character of PBMC Populations, Including T and NK Cells, as Evaluated by Multiparameter Flow Cytometry_v2||Baseline to up to 1 year|Data were not collected||||||
2619735|NCT01961115|Secondary|Change in PBMC Transcriptome_v2|Analysis of PBMC gene signature. This may be compared to immunologic response, tumor biopsy data and clinical response|Baseline to up to 16 week|Data were not collected||||||
2619736|NCT01961115|Primary|Changes in the Concentration and Number of CD8+ Cells Infiltrating Tumor by IHC by Normalization of Kyn/Trp Ratios in Combination With MELITAC 12.1|Immunohistochemistry: Tumors (day 21 & day 42) were assessed by IHC for pattern of T-cell distribution and infiltration of cells expressing CD3 and CD8.|Day 21 up to Day 42|"Neither subject in cohort A had day 42 tumor biopsy material available. For analysis of Cohort All Other Patients n = 6 due to either a day 21 biopsy missing or a missing day 42 biopsy."|||Mean Ratio: Day42CD8s/Day21CD8s||Full Range|Mean
2619737|NCT01961115|Primary|Changes in the Concentration and Number of CD8+ Cells Infiltrating Tumor by IHC by Normalization of Kyn/Trp Ratios.|Immunohistochemistry: Tumors were assessed by IHC for pattern of T-cell distribution and infiltration of cells expressing CD3 and CD8.|Baseline to up to day 21|"For one subject in cohort A day 21 tumor biopsy material was not obtained (For analysis of Cohort A n = 1). For analysis of Cohort All Other Patients n = 7 due to day 21 biopsy not being obtained in 2 other subjects. In addition, for one of those subjects there was no baseline tumor biopsy obtained."|||Ratio: Day21CD8s/Day0CD8s||Full Range|Mean
2619738|NCT01961089|Primary|Agreement With Predicate Devices in Terms of Agreement 2|"Assessed Parameters:~Simulated Corneal Curvature (SimK; G6, IOLM, LS)"|3 months|SimK|||Diopters||Standard Deviation|Mean
2619739|NCT01961089|Secondary|Agreement With Devices of the Same Type in Terms of Repeatability|"Assessed parameters:~Axial Length (AL) Central Corneal Thickness (CCT) Anterior Chamber Depth (ACD) Lens Thickness (LT) Corneal Curvature (SimK) White-to-White (WtW)"|3 months|The IOLM does not measure CCT and LT. Thus, repeatability results are available with the G6 and the LS, but not with the IOLM. The IOL Master displays one average value only for WtW, which does not permit the calculation of repeatability under the present study design.|||Coefficient of variation|Eyes||Number
2619740|NCT01961089|Primary|Agreement With Predicate Devices in Terms of Agreement 1|"Assessed parameters:~Axial Length (AL; G6, IOLM, LS) Central Corneal Thickness (CCT; G6, LS)) Anterior Chamber Depth (ACD; G6, IOLM, LS) Lens Thickness (LT; G6, LS) Corneal Curvature (SimK; G6, IOLM, LS) White-to-White (WtW; G6, IOL, LS)"|3 months|The measurement of Central Corneal Thickness (CCT) and Lens Thickness (LT) is not possible with the IOLM: the IOLM cannot measure these two parameters and does therefore not display results for CCT and LT. As a consequence, the comparison in CCT and LT is only possible between the G6 and the LS, but not with respect to the IOLM.|||Units are mm|eyes|Standard Deviation|Mean
2619741|NCT01960907|Post-Hoc|Difference of Hospitalization Rate|Difference between the hospitalization rate during the study and the previous year. For each patient, hospitalization rate was defined as the number of hospital admissions during a period divided by the length (in days) of the period. Number of hospitalizations was collected by the hospital clinical records.|Baseline and 9 months||||hospitalizations/year/patient||Inter-Quartile Range|Median
2619775|NCT01960790|Secondary|Number of Participants With Degree of Improvement of Endoscopic Findings|The number of participants with improvement in endoscopic findings is assessed.|Up to Week 156|All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy.|||Participants|||Count of Participants
2619742|NCT01960907|Primary|Final Utility Index of EQ-5D Questionnaire|The quality of life of patients as quantified by the final utility index of the EQ-5D questionnaire. The utility index ranges from -0.074 to 1 with 1 being the highest possible quality of life.|9 months|An intention to treat analysis has been applied for the primary outcomes of the trial. Multiple Imputation (MI) was used to assign values were data were missing. However for a limited number of patient, due to the fact that all data were missing, we couldn't apply any imputation method and therefore they have been excluded.|||units on a scale||Standard Deviation|Mean
2619743|NCT01960907|Primary|Time to First Hospitalization|It represents the number of days, since the enrolment into the study, to the first hospitalization|From enrolment up to 9 months|An intention to treat analysis has been applied for the primary outcomes of the trial and all the randomized patients have been retained for the analysis.|||days||Inter-Quartile Range|Mean
2619744|NCT01960855|Secondary|Number of Subjects Achieving CR Based on DAS28 at Week 12|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hs CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. LOCF was used.|Baseline (Week 0) and Week 12|Subjects in the mITT population with a baseline value and at least 1 post-baseline value.|||Participants|||Count of Participants
2619745|NCT01960855|Secondary|Number of Subjects Achieving Low Disease Activity (LDA) Based on Disease Activity Score (DAS28) or Clinical Remission (CR) Based on (DAS28) at Week 12|LDA is defined as DAS28 from 2.6 to < 3.2 at Week 12. CR is defined as DAS28 (CRP) < 2.6 at Week 12. The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, hs CRP, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. LOCF was used.|Baseline (Week 0) and Week 12|Subjects in the mITT population with a baseline value and at least 1 post-baseline value.|||Participants|||Count of Participants
2619746|NCT01960855|Secondary|Number of Subjects Achieving American College of Rheumatology 70% (ACR70) Response at Week 12|Response defined as at least 70% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hs CRP. LOCF was used.|Baseline (Week 0) and Week 12|Subjects in the mITT population with a baseline value and at least 1 post-baseline value.|||Participants|||Count of Participants
2619747|NCT01960855|Secondary|Number of Subjects Achieving American College of Rheumatology 50% (ACR50) Response at Week 12|Response defined as at least 50% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, PtGA; PGA, HAQ-DI, and hs CRP. LOCF was used.|Baseline (Week 0) and Week 12|Subjects in the mITT population with a baseline value and at least 1 post-baseline value.|||Participants|||Count of Participants
2619748|NCT01960855|Primary|Number of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 12|Response defined as at least 20% reduction (improvement) compared with baseline in tender joint count (TJC68), swollen joint count (SJC66), and at least 3 of the 5 remaining ACR core set measures: patient's assessment of pain, patient's global assessment of disease activity (PtGA); physician's global assessment of disease activity (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), and high-sensitivity C-reactive protein (hs CRP). Last observation carried forward (LOCF) was used for missing data.|Baseline (Week 0) and Week 12|Subjects in the modified intent-to-treat (mITT) population with a baseline value and at least 1 post-baseline value|||Participants|||Count of Participants
2619749|NCT01960842|Other Pre-specified|Physical Examination|Any abnormal findings are recorded as an adverse event after the first study drug administration; please see the AE section below. Further analysis for physical examination findings was not performed per protocol.|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|||||||
2619750|NCT01960842|Other Pre-specified|Neurological Examination|Any abnormal findings are recorded as an adverse event after the first study drug administration; please see the AE section below. Further analysis for neurological examination findings was not performed per protocol.|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|||||||
2619751|NCT01960842|Secondary|Number of Participants With Potentially Clinically Significant Values for 12-lead Electrocardiogram (ECG)|Terms abbreviated in the table include heart rate (HR) in beats per minute (bpm), PR interval (PRI), QT interval corrected for heart rate using Bazett's formula (QTcB), QT interval corrected for heart rate using Fridericia's formula (QTcF), and baseline (BL). Increase and decrease are signified by ↑ and ↓, respectively. n = the number of participants with available data at each time point.|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|Safety analysis set.|||participants|||Number
2619752|NCT01960842|Secondary|Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters|Terms abbreviated in the table include upper limit of normal (ULN), male (m), and female (f).|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|Safety analysis set.|||participants|||Number
2619753|NCT01960842|Secondary|Number of Participants With Potentially Clinically Significant Values for Hematology Parameters|Terms abbreviated in the table include females (f), males (m), and femtoliters (fL).|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|Safety analysis set.|||participants|||Number
2619754|NCT01960842|Secondary|Number of Participants With Potentially Clinically Significant Vital Sign Parameters|Terms abbreviated in the table include supine systolic blood pressure (SuSBP), standing systolic blood pressure (StSBP), orthostatic systolic blood pressure (OSBP), supine diastolic blood pressure (SuDBP), standing diastolic blood pressure (StDBP), orthostatic diastolic blood pressure (ODBP), supine pulse (SuP) in beats per minute (bpm), standing pulse (StP), body temperature (Temp), and baseline (BL). Increase and decrease are signified by ↑ and ↓, respectively.|From Baseline (end of screening period) to Final PEG-J Visit (up to week 12)|Safety analysis set.|||participants|||Number
2620007|NCT01958606|Other Pre-specified|Change in Transcranial Magnetic Stimulation (TMS) Responses From Baseline to 4 Weeks|Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency, corticomotor map size and volume and intracortical inhibition|Baseline and 4 weeks|measure not used||||||
2619755|NCT01960842|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|"An adverse event (AE) is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent AEs (TEAEs) are defined as any event that began or worsened in severity after N-J placement. The investigator assessed the relationship of each event to the use of study drug as Reasonable Possibility or No Reasonable Possibility.~For more details on adverse events please see the AE section below."|From N-J placement to the end of study or early termination of treatment, including the removal of PEG-J (up to 17 weeks), plus 30 days.|Safety Analysis Set: All subjects who had undergone the N-J placement procedure.|||participants|||Number
2619756|NCT01960842|Secondary|"Average Daily Normalized Off Time at Baseline and Each Visit: Change From Baseline To The Final PEG-J Visit"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. n= the number of participants with available data at each time point."|Baseline (end of screening period) and Weeks 2, 4, 6, 8, 10, and 12|All participants in the FAS with available data.|||hours||Standard Deviation|Mean
2619757|NCT01960842|Secondary|"Average Daily Normalized Off Time Including All PD Diaries Regardless if They Were Completed After the Subject Had Used a Concomitant Anti-Parkinsonian Medication: Change From Baseline To The Final PEG-J Visit"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.|||hours||Standard Deviation|Mean
2619758|NCT01960842|Secondary|"Average Daily Normalized Off Time Excluding Subjects Who Did Not Receive LCIG During the Entire PEG-J Period: Change From Baseline To The Final PEG-J Visit"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.|||hours||Standard Deviation|Mean
2619759|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0 to 23 and higher scores are associated with more disability.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.|||units on a scale||Standard Deviation|Mean
2619760|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0 to 16 and higher scores are associated with more disability.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.|||units on a scale||Standard Deviation|Mean
2619761|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Total Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0 to176, with 176 representing the worst (total) disability, and 0 representing no disability.|Baseline and Final PEG-J Visit (up to Week 12)|All participants in the FAS.|||units on a scale||Standard Deviation|Mean
2619762|NCT01960842|Secondary|Parkinson's Disease Questionnaire (PDQ-39) Mobility, Emotional Well-Being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort Domain Scores: Change From Baseline To The Final PEG-J Visit|The PDQ-39 is a self-administered questionnaire which comprises 39 items (each question answered on a 5-point scale) addressing 8 domains of health in Parkinson's disease patients: Mobility (e.g., fear of falling when walking) includes 10 questions; Emotional Well-being (e.g., feelings of isolation) includes 6 questions; Stigma (e.g., social embarrassment) includes 4 questions; Social Support includes 3 questions; Cognition includes 4 questions; Communication includes 3 questions; and Bodily Discomfort includes 3 questions. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.|||units on a scale||Standard Deviation|Mean
2619776|NCT01960790|Secondary|Number of Participants With Accessory Symptoms of Behcet's Disease|The presence or absence of symptoms including arthritis without deformity or stiffness, epididymitis, vascular lesions and moderate to severe central nervous system (CNS) lesions was assessed at weeks 52, 104 and 156 against presence or absence at baseline.|Up to Week 156|All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy.|||Participants|||Count of Participants
2619763|NCT01960842|Secondary|"Average Daily Normalized On Time With Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from baseline for on time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.|||hours||Standard Deviation|Mean
2619764|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part IIl Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.|||units on a scale||Standard Deviation|Mean
2619765|NCT01960842|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score: Change From Baseline To The Final PEG-J Visit|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.|||units on a scale||Standard Deviation|Mean
2619766|NCT01960842|Secondary|Patient Global Impression of Change (PGI-C) Score at the Final PEG-J Visit|"The PGI-C is a 7-point response scale. The subjects were to rate their change in status from Screening Visit 1 using the following 7-point scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse. The responses of Minimally improved, Much improved, and Very much improved on the PGI-C were used to define responders."|Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.|||units on a scale||Standard Deviation|Mean
2619767|NCT01960842|Secondary|Clinical Global Impression - Change (CGI-I) Score at the Final PEG-J Visit|The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.|Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.|||units on a scale||Standard Deviation|Mean
2619768|NCT01960842|Secondary|Parkinson's Disease Questionnaire (PDQ-39) Summary Index: Change From Baseline To The Final PEG-J Visit|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS.|||units on a scale||Standard Deviation|Mean
2619769|NCT01960842|Secondary|"Average Daily Normalized On Time Without Troublesome Dyskinesia: Change From Baseline To The Final PEG-J Visit"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from baseline for on time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the FAS with available data.|||hours||Standard Deviation|Mean
2619770|NCT01960842|Primary|"Average Daily Normalized Off Time: Change From Baseline To The Final PEG-J Visit"|"Based on the Parkinson's Disease Symptom Diary. On time is when PD symptoms are well controlled by the drug. Off time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for off time indicates improvement."|Baseline (end of screening period) and Final PEG-J Visit (up to week 12)|All participants in the Full Analysis Set (FAS; all enrolled participants who received at least 1 dose of LCIG infusion during the PEG-J Period and had data for baseline and at least 1 post-PEG-J efficacy assessment) with available data.|||hours||Standard Deviation|Mean
2619771|NCT01960816|Post-Hoc|NOSE Score at 90-day Follow-up|The Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific health status outcomes instrument, used to assess severity of nasal obstruction symptoms. Score ranges from 0 to 100. Higher scores indicate increased symptoms/symptom severity. Each subject's NOSE score at the 90-day follow-up was compared to that subject's baseline NOSE score to determine change in nasal obstruction symptoms.|90 days|Subjects with 90-day follow-up data|||units on a scale||Standard Deviation|Mean
2619772|NCT01960816|Primary|Technical Feasibility as Assessed by the Ability of the InFlux Device to Deliver RF Energy to Target Tissue|Ability of the InFlux device to deliver RF energy at the selected power setting, and to reach and maintain the selected target temperature.|Procedure, up to 1 hour (average, 16 minutes)|All enrolled subjects underwent the procedure.|||participants|||Number
2619773|NCT01960816|Primary|Incidence of Unanticipated Serious Adverse Device Effects|The study will be considered to have met its primary safety endpoint if no subject experiences an unanticipated serious adverse device effect (USADE defined as any serious adverse effect caused by, or associated with, the investigational device, that was not previously identified in nature, severity, or degree of incidence in the protocol)|90 Days|One subject was lost-to-follow-up prior to the 90-day follow-up visit. Therefore, 32 subjects were available for analysis at the 90-day time point.|||events|||Number
2619777|NCT01960790|Secondary|Number of Participants With Cardinal Symptoms of Behcet's Disease|The presence or absence of symptoms including recurrent aphthous ulcers of oral mucosa, cutaneous symptoms, eye symptoms and ulceration of vulva was assessed at weeks 52, 104 and 156 against presence or absence at baseline.|Up to Week 156|All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy.|||Participants|||Count of Participants
2619778|NCT01960790|Secondary|Global Assessment of Gastrointestinal Symptoms of Behcet's Disease|Study participants completed a global assessment of their gastrointestinal symptoms (including abdominal pain, diarrhea and other gastrointestinal symptoms such as abdominal distension, abdominal tenderness, and hemorrhage) on a 5-grade scale. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed since the last visit, but did not affect participant's daily life; 2=symptoms existed since the last visit and slightly affected participant's daily life; 3=symptoms existed since the last visit and affected participant's daily life; 4=symptoms existed since the last visit and critically affected participant's daily life.|Up to Week 156|All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy.|||Participants|||Count of Participants
2619779|NCT01960790|Secondary|Global Assessment of Gastrointestinal Symptoms|Study participants completed a global assessment of their gastrointestinal symptoms on a 5-grade scale. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed since the last visit, but did not affect participant's daily life; 2=symptoms existed since the last visit and slightly affected participant's daily life; 3=symptoms existed since the last visit and affected participant's daily life; 4=symptoms existed since the last visit and critically affected participant's daily life.|Up to Week 156|All participants who received Humira® to treat gastro-intestinal Behcet's disease and were evaluable for efficacy.|||Participants|||Count of Participants
2619780|NCT01960790|Primary|Number of Participants With Adverse Drug Reactions|The number of participants with adverse drug reactions with evaluation beginning upon administration of Humira® is assessed.|Up to Week 156|Safety analysis set: All participants who received at least one administration of Humira® during the study (after informed consent or first administration of Humira®) and for 70 days following the last scheduled administration of Humira®.|||Participants|||Count of Participants
2619781|NCT01960725|Other Pre-specified|Serious Adverse Event Assessment|Proportions of subjects in each vaccine group reporting an adverse event in the period following each dose and any dose of RV5 will be determined|After each dose and up to 10 months post-vaccination||||Proportion of participants|||Number
2619782|NCT01960725|Other Pre-specified|Adverse Event Assessment|Proportions of subjects in each vaccine group reporting an adverse event in the period following each dose and any dose of RV5 will be determined|28 days after each dose, up to 10 months post-vaccination||||Proportion of participants|||Number
2619783|NCT01960725|Other Pre-specified|Reactogenicity Assessment|Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any dose of RV5 will be determined|7 days after each dose, up to 10 months post-vaccination|Proportions of subjects in each vaccine group reporting a reactogenicity event in the period following each dose and any does of RV5 will be determined|||Proportion of participants|||Number
2619784|NCT01960725|Other Pre-specified|Serum Rotavirus Immunoglobulin A|Post dose 3 serum rotavirus Immunoglobulin A geometric mean titer (GMT)|1 month following vaccine series completion|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||titers||95% Confidence Interval|Geometric Mean
2619785|NCT01960725|Secondary|P1 Serum-neutralizing Antibody|Post dose 3 P1 serum-neutralizing antibody(SNA) geometric mean titer (GMT)|1 month following vaccine series completion|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||titers||95% Confidence Interval|Geometric Mean
2619786|NCT01960725|Secondary|G4 Serum-neutralizing Antibody|Post dose 3 G4 serum-neutralizing antibody(SNA) geometric mean titer (GMT)|1 month following vaccine series completion|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||titers||95% Confidence Interval|Geometric Mean
2619787|NCT01960725|Secondary|G3 Serum-neutralizing Antibody|Post dose 3 G3 serum-neutralizing antibody(SNA) geometric mean titer (GMT)|1 month following vaccine series completion|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||titers||95% Confidence Interval|Geometric Mean
2619788|NCT01960725|Secondary|G2 Serum-neutralizing Antibody|Post dose 3 G2 serum-neutralizing antibody(SNA) geometric mean titer (GMT)|1 month following vaccine series completion|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||titers||95% Confidence Interval|Geometric Mean
2619789|NCT01960725|Primary|G1 Serum-neutralizing Antibody|Post dose 3 G1 serum-neutralizing antibody (SNA) geometric mean titer (GMT)|1 month following vaccine series completion|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported.|||titers||95% Confidence Interval|Geometric Mean
2619790|NCT01960530|Primary|AUC0-t|Derived PK for Serum Cortisol: Area under the curve from 0-24 hours|Hourly from 0 to 24 hours|All randomised subjects who received no IMP (no treatment), dexamethasone, oral Infacort®, hydrocortisone tablet and i.v. hydrocortisone, had sufficient serum cortisol concentration by time profiles and who did not violate the protocol|||nmol*h/L||Standard Deviation|Geometric Mean
2619791|NCT01960530|Secondary|PK and Metabolism of Cortisol|Blood: Serum cortisol under physiological conditions and after administration of dexamethasone and Infacort® Granules, Hydrocortisone Tablets and i.v Hydrocortisone Injection.|Blood, urine & saliva samples on Day 1 and/or Day 2 of each Study Period||||nmol/L||Standard Deviation|Mean
2619792|NCT01960530|Secondary|Insulin Sensitivity Under Physiological Conditions and After Administration of Dexamethasone and Infacort®, Hydrocortisone Tablets and i.v Hydrocortisone.|A standardised mixed meal elevates blood glucose and provides a reproducible stimulation of insulin release. Lower levels of insulin secretion, whilst maintaining normoglycaemia would indicate enhanced insulin sensitivity and glucose disposal; higher insulin levels will reflect insulin resistance.|Blood samples on Day 1 and/or Day 2 of each Study Period||||uIU/mL||Standard Deviation|Mean
2619793|NCT01960530|Secondary|Concentrations of Cortisol Binding Protein|Cortisol protein binding under physiological conditions and after the administration of dexamethasone and hydrocortisone.|Blood samples on Day 1 and/or Day 2 of each Study Period||||ug/mL||Standard Deviation|Mean
2619794|NCT01960530|Secondary|Adverse Events (AEs)|Number of subjects with adverse events throughout the study.|Days 1-2 during each Study Period||||participants|||Number
2619795|NCT01960530|Primary|Maximum Serum Concentration (Cmax)|Derived PK for Serum Cortisol: Maximum serum concentration (Cmax)|Hourly from 0 to 24 hours|All randomised subjects who received no IMP (no treatment), dexamethasone, oral Infacort®, hydrocortisone tablet and i.v. hydrocortisone, had sufficient serum cortisol concentration by time profiles and who did not violate the protocol|||nmol/L||Standard Deviation|Geometric Mean
2619796|NCT01960413|Primary|Change in Soluble Vascular Cell Adhesion Molecule-1 (sVCAM)|The primary outcome measure is based on a 30% reduction, which would be ~106 ng/ml reduction. The study was designed with 25 in each group in order to explore all three aims and potential confounders. However, if the investigators are not able to accrue 25 subjects in each arm, the investigators would still be able to detect a 30% difference in sVCAM with 17 subjects in each group. The 95% confidence interval for detecting a 30% difference is between 204 ng/ml and 290 ng/ml (or an 18-42% reduction in sVCAM). Importantly, the lower limit of the 95% confidence interval (18%) is still a clinically relevant reduction in sVCAM. Thus, if the investigators detect a 30% or larger difference in sVCAM in this study, the investigators will be assured that, based on the 95% confidence interval, these data are clinically important.|baseline to eight weeks||||ng/mL||Inter-Quartile Range|Median
2619797|NCT01960400|Secondary|State Anxiety|The State-Trait Anxiety Inventory (STAI) was used to assess the state of anxiety at the moment (Spielberg et al., 1983). The total score is obtained by adding the scores for all 20 questions range from 20 to 80; the higher the result is, the higher is the anxiety about an event.|Before (T0) and after treatment (6 weeks) (T1)||||units on a scale||Standard Deviation|Mean
2619798|NCT01960400|Secondary|Kinesiophobia|The Tampa Scale of kinesiophobia (TSK) (Kori et al., 1990) was used to assess fear of movement and injury/(re)injury. The TSK questionnaires consist of 17 items. Each item, composed of a statement, is scored by the patient on a 4-point Likert scale of 1 (strongly disagree) to 4 (strongly agree). The total scores range from 17 to 68, with higher scores representing stronger fear-avoidance beliefs (Clark, Kori, Brockel, 1996).|Before (T0) and after treatment (6 weeks) (T1)||||units on a scale||Standard Deviation|Mean
2619799|NCT01960400|Secondary|Pain Catastrophizing|"The Pain catastrophizing scale (PCS) (Sullivan et al., 1995) was used to evaluate the feelings, thoughts, and emotions related to pain catastrophizing of the patient. The PCS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness.~* The scores ranging from 0 to 52 points (sum of the tree subscales), with higher scores representing stronger pain catastrophizing (Sullivan et al., 1995)."|Before (T0) and after treatment (6 weeks) (T1)||||units on a scale||Standard Deviation|Mean
2619800|NCT01960400|Primary|Pain Severity|"The choice of outcome measures was performed in accordance with Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT) guidelines (Dworkin et al., 2005). All instruments were used before (T0) and after 6 weeks of treatment (T1).~The primary outcome measure was pain severity as measured with the Brief pain inventory short-form (BPI-sf) (Poundja et al., 2007). The BPI-sf includes four questions on pain levels, where subjects were asked to rate intensity on a scale of 0 (no pain) to 10 (worst possible pain) for: (1) pain at its worst in the last 24 hours; (2) pain at its least in the last 24 hours; (3) pain on average in the last 24 hours; (4) pain right now. The total score ranges from 0 to 40 (sum of the four subscales). The higher the score, the greater the severity of the pain is severe."|Before (T0) and after treatment (6 weeks) (T1)||||units on a scale||Standard Deviation|Mean
2619801|NCT01960387|Secondary|Predictive Factors for Response to Treatment.|Evaluation of potential factors that are predictive of clinical response in newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day).|Up to 1 year|Results data are not available due to low/insufficient subject accrual from early [trial] termination.||||||
2619802|NCT01960387|Secondary|Relapse Free Survival|Number of months of relapse free survival for newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day).|Up to 24 months|Results data are not available due to low/insufficient subject accrual from early [trial] termination.||||||
2619803|NCT01960387|Secondary|Overall Survival|Number of months of survival for newly diagnosed Acute Myeloid Leukemia patients treated with Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day).|Up to 24 months|Results data are not available due to low/insufficient subject accrual from early [trial] termination.||||||
2619804|NCT01960387|Primary|Complete Clinical Response|Number of patients with newly diagnosed Acute Myeloid Leukemia who achieved Complete Response to therapy as determined by bone marrow biopsy evaluation. A CR designation required that the patient achieved a morphologic leukemia-free state and an absolute neutrophil count greater than or equal to 1.0 x 10^9/l, a platelet count greater than or equal to 100 x 10^9/l, and no evidence of extramedullary disease.|Between 14 and 28 days from start of study treatment|Newly diagnosed Acute Myeloid Leukemia patients who received clofarabine (1-2 hour intravenous infusion of 40mg/m2 daily dose) plus cytarabine (2-4 hours maximum intravenous infusion of 1g/m2 daily dose) starting 3-4 hours post completion of clofarabine administration on days 1 through 5, who were evaluable for response by bone marrow biopsy.|||participants|||Number
2620008|NCT01958606|Other Pre-specified|Change in Gait Kinematics/Kinetics During Session 1|3D motion capture and force plates|During session 1|measure not used||||||
2620009|NCT01958606|Other Pre-specified|Change in Gait Kinematics/Kinetics From Baseline to Post Session 1|3D motion capture and force plates|Baseline and after session 1|measure not used||||||
2619805|NCT01960348|Secondary|Autonomic Symptoms Questionnaire (Composite Autonomic Symptom Score [COMPASS 31])|The difference between the patisiran (ALN-TTR02) and placebo groups in the change from baseline in COMPASS 31 at 18 months. The COMPASS 31 is a measure of autonomic neuropathy symptoms. The questions evaluated 6 autonomic domains (orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor). The minimum and maximum values are 0 and 100, respectively. A higher score indicates a worse outcome.|18mo|Per protocol (PP) population: All randomized participants who received at least 1 dose of patisiran-LNP or placebo, completed baseline and the 18-month COMPASS 31 assessments, and did not experience any major protocol deviations that may have impacted the efficacy results.|||score on a scale||Standard Error|Least Squares Mean
2619806|NCT01960348|Secondary|Modified Body Mass Index (mBMI)|The difference between the patisiran (ALN-TTR02) and placebo groups in the change from baseline in mBMI at 18 months. The nutritional status of patients was evaluated using the mBMI; calculated as the product of BMI (weight in kilograms divided by the square of height in meters) and serum albumin (g/L).|18mo|Per protocol (PP) population: All randomized participants who received at least 1 dose of patisiran-LNP or placebo, completed baseline and the 18-month mBMI assessments and did not experience any major protocol deviations that may have impacted the results..|||kg/m^2 × albumin g/L||Standard Error|Least Squares Mean
2619807|NCT01960348|Secondary|Timed 10-meter Walk Test (10-MWT, Gait Speed)|The difference between the patisiran (ALN-TTR02) and placebo groups in the change from baseline in 10-MWT at 18 months. Ability to ambulate (gait speed) was assessed through the 10-meter walk test (10-MWT). The walk had to be completed without assistance from another person; ambulatory aids such as canes and walkers were permitted.|18mo|Per protocol (PP) population: All randomized participants who received at least 1 dose of patisiran-LNP or placebo, completed baseline and the 18-month 10-MWT assessments, and did not experience any major protocol deviations that may have impacted the efficacy results.|||m/sec||Standard Error|Least Squares Mean
2619808|NCT01960348|Secondary|Rasch-built Overall Disability Scale (R-ODS) Score|The difference between the patisiran (ALN-TTR02) and placebo groups in the change from baseline in R-ODS score at 18 months. The R-ODS is comprised of a 24-item linearly weighted scale that specifically captures activity and social participation limitations in patients. The minimum and maximum values are 0 and 48, respectively. A higher score indicates a better outcome.|18mo|Per protocol (PP) population: All randomized participants who received at least 1 dose of patisiran-LNP or placebo, completed baseline and either the 18-month R-ODS assessments, and did not experience any major protocol deviations that may have impacted the efficacy results.|||score on a scale||Standard Error|Least Squares Mean
2619809|NCT01960348|Secondary|Neurological Impairment Score-Weakness (NIS-W) Score|The difference between the patisiran (ALN-TTR02) and placebo groups in the change from baseline in NIS-W at 18 months. NIS-W is a measure of motor strength, comprised of cranial nerve and both upper and lower limb motor assessments. The minimum and maximum values are 0 and 192, respectively. A higher score indicates a worse outcome.|18mo|Per protocol (PP) population: All randomized participants who received at least 1 dose of patisiran-LNP or placebo, completed baseline and the 18-month NIS-W assessments, and did not experience any major protocol deviations that may have impacted the efficacy results.|||score on a scale||Standard Error|Least Squares Mean
2619810|NCT01960348|Secondary|Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QoL-DN) Questionnaire|The difference between the patisiran (ALN-TTR02) and placebo groups in the change from baseline in Norfolk QoL-DN at 18 months. The Norfolk QoL-DN questionnaire is a standardized 35-item patient-reported outcomes measure that is sensitive to the different features of diabetic neuropathy - small fiber, large fiber, and autonomic nerve function. The minimum and maximum values are -4 and 136, respectively. A higher score indicates a worse outcome.|18mo|Per protocol (PP) population: All randomized participants who received at least 1 dose of patisiran-LNP or placebo, completed baseline and the 18-month Norfolk QoL-DN assessments, and did not experience any major protocol deviations that may have impacted the efficacy results.|||score on a scale||Standard Error|Least Squares Mean
2619811|NCT01960348|Primary|Modified Neuropathy Impairment Score +7 (mNIS+7)|The difference between the patisiran (ALN-TTR02) and placebo groups in the change from baseline in mNIS+7 at 18 months. The mNIS+7 is a composite score that quantitates motor, sensory, and autonomic neurologic impairment due to injury of large and small nerves. The minimum and maximum values are 0 and 304, respectively. A higher score indicates a worse outcome.|18mo|Per protocol (PP) population: All randomized participants who received at least 1 dose of patisiran-LNP or placebo, completed baseline and the 18-month mNIS+7 assessments, and did not experience any major protocol deviations that may have impacted the efficacy results.|||score on a scale||Standard Error|Least Squares Mean
2619812|NCT01960296|Secondary|Development of Myocardial Infarction or Thrombosis||up to 90 days||||participants|||Number
2619813|NCT01960296|Secondary|Same Day Discharged|Number of patients discharged on the day of surgery|up to 90 days||||participants|||Number
2619814|NCT01960296|Secondary|Average Length of Hospital Stay||up to 90 days||||days||Standard Deviation|Mean
2619815|NCT01960296|Secondary|Average Change in Hematocrit|hematocrit levels change from preoperative to postoperative|baseline and Day 1||||percent change||Standard Deviation|Mean
2619816|NCT01960296|Secondary|Procedure Time||Day 1||||minutes||Standard Deviation|Mean
2619817|NCT01960296|Primary|Perioperative Bleeding Complications|Development of perioperative bleeding complications as indicated for need for blood transfusions, hematoma, and bleeding requiring re-operation.|up to 90 days postop||||participants|||Number
2619818|NCT01960296|Secondary|Procedure Estimated Blood Loss||up to 90 days postop|Quantitative estimation of blood loss was available in 31 of the 43|||mL||Standard Deviation|Mean
2619819|NCT01960296|Primary|Bleeding-related Re-hospitalization|Perioperative Bleeding Complications as indicated by bleeding requiring re-admission.|up to 90 days post op||||participants|||Number
2619820|NCT01960140|Primary|PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Simvastatin and Simvastatin Acid|The AUC(0-∞) of simvastatin (a CYP3A substrate) and its active acid metabolite (simvastatin acid) is reported.|Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose|Participants who received study drug (simvastatin in Period 1 and at least 1 dose of baricitinib and simvastatin in Period 2) and had evaluable PK data.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2619821|NCT01960140|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Simvastatin and Simvastatin Acid|The Cmax of simvastatin [a cytochrome P450 (CYP) 3A substrate] and its active acid metabolite (simvastatin acid) is reported.|Period 1, Day 1 and Period 2, Day 6: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24 and 48 hours postdose|Participants who received study drug (simvastatin in Period 1 and at least 1 dose of baricitinib and simvastatin in Period 2) and had evaluable PK data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2619822|NCT01960114|Secondary|Patient Global Evaluation|Patient Assessment of the pain medication - Number of subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent.|12 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||percentage of participants|||Number
2619823|NCT01960114|Secondary|Duration of Pain Relief|Minutes until rescue medication was given.|Within 12 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||Minutes||95% Confidence Interval|Median
2619824|NCT01960114|Secondary|Time to Meaningful Pain Relief|Minutes until meaningful pain relief was achieved. Stopwatch was started after the subject took the study medication. The subjects were instructed to stop the stopwatch when the relief from the starting pain was meaningful to them.|Within 12 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||Minutes||95% Confidence Interval|Median
2619825|NCT01960114|Secondary|Time to Confirmed First Perceptible Pain Relief|Minutes until confirmed first perceptible pain relief was achieved. Stopwatch was started after the subject took the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relief. The first perceptible pain relief was confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.|Within 12 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||Minutes||95% Confidence Interval|Median
2619826|NCT01960114|Primary|Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)|Time weighted sum of pain intensity difference scores from baseline over 10 hours. Pain intensity was evaluated using a 0-10 numerical rating scale (NRS) where 0 = no pain and 10 = very severe pain. SPID 0-10 = 0.25 x (PID at 15 min + PID at 30 min + PID at 45 min + PID at 60 min + PID at 75 min + PID at 90 min) + 0.5 x (PID at 120 min) + PID at 3 h + PID at 4 h + PID at 5 h + PID at 6 h + PID at 7 h + PID at 8 h + PID at 9 h + PID at 10 h.|10 Hours|Analysis was based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.|||units on a scale||Standard Error|Least Squares Mean
2619827|NCT01960075|Other Pre-specified|Number of Participants With Safety Outcome: Acute Seizure Recurrence|acute seizure recurrence 60 minutes to 12 hours after start of study drug infusion|60 minutes to 12 hours after start of study drug infusion|The first 400 patients were analyzed for this outcome. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility.|||Participants|||Count of Participants
2619828|NCT01960075|Other Pre-specified|Number of Participants With Safety Outcome: Death|Safety outcome: Death|30 days|The first 400 patients were analyzed for this outcome. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility.|||Participants|||Count of Participants
2619829|NCT01960075|Other Pre-specified|Number of Participants With Safety Outcome: Purple Glove Syndrome|Purple glove syndrome is defined as the presence of all three of the findings of the objective edema: discoloration, and pain in the distal extremity in which study drug was administered, with or without known extravasation, and for which there is no other evident etiology.|24 hours|The first 400 patients were analyzed for this outcome. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility.|||Participants|||Count of Participants
2619830|NCT01960075|Other Pre-specified|Number of Participants With Safety Outcome: Hepatic Transaminase or Ammonia Elevations|Safety outcome: Hepatic transaminase or ammonia elevations|24 hours|The first 400 patients were analyzed for this outcome. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility.|||Participants|||Count of Participants
2619831|NCT01960075|Other Pre-specified|Number of Participants With Safety Outcome: Acute Respiratory Depression|Respiratory depression is defined as impairment of ventilation or oxygenation necessitating definitive endotracheal intubation and mechanical ventilation. It is distinct from intubations performed only for airway protection in those with decreased levels of consciousness. It does not include those getting only supraglottic airways or transient bag‐valve‐mask support.|24 hours|The first 400 patients were analyzed for this outcome. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility.|||Participants|||Count of Participants
2619832|NCT01960075|Other Pre-specified|Number of Participants With Safety Outcome: Acute Anaphylaxis|Acute anaphylaxis is defined as a clinical presentation consistent with life threatening allergic reaction occurring within 6 hours of the start of study drug infusions and manifested as urticaria in combination with either (1) a systolic blood pressure of < 90 mmHg sustained for greater than 5 minutes, or (2) objective evidence of airway obstruction, and for which the patient was treated with antihistamines and/or steroids.|within 6 hours of the start of study drug infusions|The first 400 patients were analyzed for this outcome. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility.|||Participants|||Count of Participants
2619833|NCT01960075|Other Pre-specified|Number of Participants With Safety Outcome: Endotracheal Intubation|Endotracheal intubation within 60 minutes of start of study drug infusion|within 60 minutes of start of study drug infusion|The first 400 patients were analyzed for this outcome. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility.|||Participants|||Count of Participants
2619834|NCT01960075|Other Pre-specified|Number of Participants With Safety Outcome: Life-threatening Cardiac Arrhythmia|Life-threatening cardiac arrhythmia within 60 minutes of the start of study drug infusion|within 60 minutes of the start of study drug infusion|The first 400 patients were analyzed for this outcome. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility.|||Participants|||Count of Participants
2620010|NCT01958606|Other Pre-specified|Change in Gait Kinematics/Kinetics From Baseline to 4 Weeks|3D motion capture and force plates|Baseline and 4 weeks|Measure not used||||||
2620011|NCT01958606|Other Pre-specified|Change in Montreal Cognitive Assessment||Baseline and 4 weeks|Measure not used||||||
2619835|NCT01960075|Other Pre-specified|Number of Participants With Safety Outcome: Life Threatening Hypotension|Life-threatening hypotension within 60 minutes of the start of study drug infusion|within 60 minutes of the start of study drug infusion|The first 400 patients were analyzed for this outcome. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility.|||Participants|||Count of Participants
2619836|NCT01960075|Secondary|Length of Hospital Stay|Length of hospital stay in days|length of hospital stay|The difference from Participant Flow is because the total of 384 is from the first 400 patients and excludes 16 re-enrollers in the study. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility.|||days||Inter-Quartile Range|Median
2619837|NCT01960075|Secondary|Number of Participants With Seizure Cessation Within 20 Minutes for Patients With Treatment Success|Number of participants with seizure cessation within 20 minutes of study drug initiation for patients with treatment success. This outcome measure was only reported in the Supplementary materials to the Primary Paper.|within 20 minutes|The population is different than Participant flow because it is only those with treatment success. This outcome measure was only reported in the Supplementary materials to the Primary Paper.|||Participants|||Count of Participants
2619838|NCT01960075|Secondary|Minutes From Start of Trial Drug Infusion to Termination of Seizures for Patients With Treatment Success|The time to termination of seizures is the interval from the start of study drug infusion to cessation of clinically apparent seizure in those who meet the primary outcome.|start of drug infusion to seizure cessation|The analysis population here is different than Participant Flow because it includes only the patients who had this data available. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility.|||minutes||Inter-Quartile Range|Median
2619839|NCT01960075|Secondary|Length of ICU Stay|Length of stay is determined by the number of calendar days after the day of ED arrival until hospital discharge or subject end-of-study.|number of calendar days after the day of ED arrival until hospital discharge or subject end-of-study|The difference from Participant Flow is because the total of 384 is from the first 400 patients and excludes 16 re-enrollers in the study. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility.|||days||Inter-Quartile Range|Median
2619840|NCT01960075|Secondary|Number of Participants With Admission to Intensive Care Unit|ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient.|Admission to intensive care unit after start of study drug infusion, where the ICU is the initial inpatient unit for the patient|The difference from Participant Flow is because the total of 384 is from the first 400 patients and excludes 16 re-enrollers in the study. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility.|||Participants|||Count of Participants
2619841|NCT01960075|Primary|Number of Participants With Clinical Cessation of Status Epilepticus - Adjudicated Outcomes Analysis|Determined by the absence of clinically apparent seizures and improving consciousness at 1 hour without other anticonvulsant medications. The Adjudicated outcomes analysis is different from Outcome measure 1 because a central clinical phenomenology core of four neurologists adjudicated from the medical records the time to seizure cessation, the time in status epilepticus before trial-drug initiation, and the cause of the seizure. For each enrollment, two neurologists from this core group conducted independent initial reviews and then determined a consensus or consulted a third adjudicator, as needed. Adjudicators were unaware of the treatment assignments and made determinations by medical record review.|Within 60 minutes after the start of study drug infusion|The difference from Participant Flow is because the total of 384 is from the first 400 patients and excludes 16 re-enrollers in the study. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility.|||Participants|||Count of Participants
2619842|NCT01960075|Primary|Number of Participants With Clinical Cessation of Status Epilepticus - Per-protocol Analysis|Determined by the absence of clinically apparent seizures and improving consciousness at 1 hour without other anticonvulsant medications. Per-protocol analysis|Within 60 minutes after the start of study drug infusion|The analysis population for this outcome is the Per-protocol population, which is all patients who completed the study without major protocol deviations.|||Participants|||Count of Participants
2619843|NCT01960075|Primary|Number of Participants With Clinical Cessation of Status Epilepticus - Intention to Treat|Determined by the absence of clinically apparent seizures and improving consciousness at 1 hour without other anticonvulsant medications. Intention to treat|Within 60 minutes after the start of study drug infusion|The difference from Participant Flow is because the total of 384 is from the first 400 patients and excludes 16 re-enrollers in the study. The first 400 patients were used because of the prespecified stopping rule and the trial stopped for futility.|||Participants|||Count of Participants
2619844|NCT01959945|Secondary|Seroprotection to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Seroprotection is defined as: A titer ≥ 40 (l/dil) at pre vaccination and at Day 28 after the final vaccination.|Day 28 after final vaccination|The evaluable immunogenicity population includes randomized subjects who received the assigned number of doses of study vaccine and have HAI titers available from blood draws taken at baseline and ~28 days following completion of immunization (~Day 56 for 2-dose subjects), which accounts for the discrepancy in Participants Analyzed.|||percentage of participants||95% Confidence Interval|Number
2619845|NCT01959945|Secondary|Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Seroconversion is defined as: Either a pre vaccination titer < 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at Day 28 after the final vaccination.|Day 28 after final vaccination|The evaluable immunogenicity population includes randomized subjects who received the assigned number of doses of study vaccine and have HAI titers available from blood draws taken at baseline and ~28 days following completion of immunization (~Day 56 for 2-dose subjects), which accounts for the discrepancy in Participants Analyzed.|||percentage of participants||95% Confidence Interval|Number
2619867|NCT01959841|Secondary|Time to Cessation of New Lesion Formation|"The investigator assessed the Number of rashes (erythemas/papulae and vesicles/pustules). The new lesion formation was defined as the state in which the number of rashes is increasing."|29days|The full analysis set(FAS).The FAS was defined as patients who were diagnosed with herpes zoster at the time of case registration, who subsequently received the study drugs, and had any efficacy variable measured.|||days||Inter-Quartile Range|Median
2619846|NCT01959945|Secondary|Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine|Immunogenicity will be evaluated prior to vaccination and at 28 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) and seroprotection and seroconversion will be calculated.|Day 0 and Day 28 after final vaccination (Cohort B includes 1-Dose subjects at Day 28 and 2-Dose subjects at Day 56)|The evaluable immunogenicity population includes randomized subjects who received the assigned number of doses of study vaccine and have HAI titers available from blood draws taken at baseline and ~28 days following completion of immunization (~Day 56 for 2-dose subjects), which accounts for the discrepancy in Participants Analyzed.|||titer||95% Confidence Interval|Geometric Mean
2619847|NCT01959945|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Events and Unsolicited Adverse Events Following Vaccination With Quadrivalent Vaccine.|Solicited injection site reactions: Pain, Bruising, Redness, and Swelling; Solicited systemic reactions: Headache, Chills, Fever, Fatigue, Muscle Pain, Joint Pain and Nausea.|Day 0 up to Day 28 post vaccination||||participants|||Number
2619848|NCT01959932|Primary|Levels of Carboxyhemoglobin (COHb)|"% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."|||% of saturation of hemoglobin||95% Confidence Interval|Least Squares Mean
2619849|NCT01959932|Primary|Concentration of S-phenylmercapturic Acid (S-PMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."|||pg/mg creat||95% Confidence Interval|Least Squares Mean
2619850|NCT01959932|Primary|Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid BoExp measurement (THS 2.2, CC, SA arms)."|||ng/mg creat||95% Confidence Interval|Least Squares Mean
2619851|NCT01959932|Primary|Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)|"Concentrations measured at Day 5 in urine, adjusted for creatinine.~Geometric Least Squares (LS) means are provided as descriptive statistics."|5 days|"The analysis was performed on the full analysis set (FAS) population.~The FAS consisted of all the randomized subjects who had at least 1 post randomization product use experience (if randomized to THS 2.2 or CC) and had at least 1 valid biomarker of exposure (BoExp) measurement (THS 2.2, CC, SA arms)."|||pg/mg creat||95% Confidence Interval|Least Squares Mean
2619852|NCT01959919|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) was any untoward medical occurrence in a participant who received treatment using Refacto AF Fusnego without regard to possibility of causal relationship. Serious adverse event was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious AEs.|Baseline up to 28 days after last dose of drug (up to Month 12)|Safety population included all the participants who were enrolled and received at least 1 dose of Refacto AF FuseNGO.|||participants|||Number
2619853|NCT01959919|Primary|Overall Satisfaction Score With Refacto AF FuseNGO|HaemoPREF: participant rated 14-item instrument to measure experience of clotting factor treatment. 14 items: 1) ease to prepare treatment for injection, 2) ease to store treatment, 3) ease to dispose container, syringe, needle once used and 4) ease to use treatment, 5) time consumed with treatment, 6) difficulty in finding a vein to inject treatment, 7) difficulty to travel, 8) difficulty to do daily activities, 9) difficulty to do social or leisure activities, 10) worried for getting infected with other disease while using the treatment, 11) worried to contaminate the treatment while preparing for injection, 12) worried to inject by own, 13) importance of family's opinion to use treatment, 14) importance what others use for their hemophilia. Each item was scaled from 0 (no satisfaction) to 10 (maximum satisfaction). Overall satisfaction score was the sum of 14 items, ranged from 0 (no satisfaction) to 140 (maximum satisfaction). Higher scores indicate greater treatment satisfaction.|Final Visit (Month 8)|"Per-protocol population included all participants who received at least 1 treatment using the Refacto AF FuseNGo and completed the two final questionnaires. Here N signifies number of participants evaluable for this outcome measure."|||units on a scale||Standard Deviation|Mean
2619854|NCT01959919|Primary|Risk Associated With Clotting Factor Treatment Score|HaemoPREF is a participant rated 14-item instrument to measure experience of clotting factor treatment including ease of use, burden, impact, risk and influence of others on treatment choices. For determining score for risk associated with clotting factor treatment, 3 items were assessed by participants: 1) worried about getting infected with other disease while using the treatment, 2) worried to contaminate the treatment while preparing for injection and 3) worried to inject treatment by own. Each of the 3 items was scored on a scale of 0 (most concerned) to 10 (not at all concerned), and summed up to give a total overall score range of 0 (most worried) to 30 (least worried). Higher scores indicate lower levels of worry associated with treatment.|Final Visit (Month 8)|Per-protocol population included all participants who received at least 1 treatment using the Refacto AF FuseNGo and completed the two final questionnaires.|||units on scale||Standard Deviation|Mean
2619866|NCT01959841|Secondary|Time to Complete Crusting|"We defined the following state as Complete crusting.~A condition where all lesions of erythemas/papulae, vesicles/pustules, and erosions/ulcers have disappeared, and all rashes are crusted (epithelialization of the base of crusts is not required).~In subjects with no formation of vesicles or pustules, a condition where all lesions of erythemas/papulae have disappeared."|29days|The full analysis set(FAS).The FAS was defined as patients who were diagnosed with herpes zoster at the time of case registration, who subsequently received the study drugs, and had any efficacy variable measured.|||days||Inter-Quartile Range|Median
2619855|NCT01959919|Primary|Impact of Clotting Factor Treatment Score|HaemoPREF is a participant rated 14-item instrument to measure experience of clotting factor treatment including ease of use, burden, impact, risk and influence of others on treatment choices. For determining score for impact of clotting factor treatment, 3 items were assessed by participants: 1) difficulty to travel for holidays or works, 2) difficulty to perform daily activities including work or study and 3) difficulty to perform social or leisure activities. Each of the 3 items was scored on a scale of 0 (most challenging) to 10 (least challenging), and summed up to give a total overall score range of 0 (greatest negative impact) to 30 (least negative impact). Higher scores indicate less negative impact on daily life.|Final Visit (Month 8)|Per-protocol population included all participants who received at least 1 treatment using the Refacto AF FuseNGo and completed the two final questionnaires.|||units on scale||Standard Deviation|Mean
2619856|NCT01959919|Primary|Burden of Clotting Factor Treatment Score|HaemoPREF is a participant rated 14-item instrument to measure experience of clotting factor treatment including ease of use, burden, impact, risk and influence of others on treatment choices. For determining the score for burden of clotting factor treatment, 2 items were assessed by participants: 1) time consumption to treat with treatment and 2) difficulty in finding vein to inject treatment in to. Each of the 2 items was scored on a scale of 0 (most difficult) to 20 ( least difficult) and summed up to give a total overall score range of 0 (most burdened) to 40 (least burdened). Higher scores indicate a lower burden of treatment.|Final Visit (Month 8)|Per-protocol population included all participants who received at least 1 treatment using the Refacto AF FuseNGo and completed the two final questionnaires.|||units on scale||Standard Deviation|Mean
2619857|NCT01959919|Primary|Time for Reconstructing the Drug|In this outcome measure time consumed for performing steps to reconstitute the drug prior to infusion of drug is reported.|Final Visit (Month 8)|"Per-protocol population all participants who received at least 1 treatment using the Refacto AF FuseNGo and completed the two final questionnaires. Here Number of Participants Analyzed (N) signifies number of participants who were evaluable for this outcome measure."|||minutes||Standard Deviation|Mean
2619858|NCT01959919|Primary|Ease of Using Clotting Factor Treatment Score|HaemoPREF is a participant rated 14-item instrument to measure experience of clotting factor treatment including ease of use, burden, impact, risk and influence of others on treatment choices. For determining score for ease of using clotting factor treatment, 4 items assessed by participants were: 1) ease to prepare treatment for injection, 2) ease to store treatment, 3) ease to dispose of containers, syringe and needle once used and 4) ease to use current treatment. Each of the 4 items was scored on a scale of 0 (not at all easy) to 10 (extremely easy), and were summed up, to give a total overall score range of 0 (no ease) to 40 (maximum ease). Higher scores indicate greater ease in using clotting factor treatment.|Final Visit (Month 8)|Per-protocol population included all participants who received at least 1 treatment using the Refacto AF FuseNGo and completed the two final questionnaires.|||units on a scale||Standard Deviation|Mean
2619859|NCT01959880|Primary|6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|6 years|All enrolled subjects are included.|||percentage of subjects||95% Confidence Interval|Number
2619860|NCT01959880|Primary|6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|6 years|All enrolled subjects are included.|||percentage of subjects||95% Confidence Interval|Number
2619861|NCT01959880|Primary|6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture|"Baker III was identified as firm with visible distortion and Baker IV was identified as obvious spherical distortion. Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest."|6 years|All enrolled subjects are included.|||percentage of subjects||95% Confidence Interval|Number
2619862|NCT01959880|Primary|6-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation|Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest.|6 years|All enrolled subjects are included.|||percentage of subjects||95% Confidence Interval|Number
2619863|NCT01959841|Secondary|Time to Virus Disappearance|Virus desiappearance was defined as the participants who who reached virus-negative status according to the virus isolation and culture assay or whose samples were not available because of complete crusting or healing|29days|The full analysis set(FAS).The FAS was defined as patients who were diagnosed with herpes zoster at the time of case registration, who subsequently received the study drugs, and had any efficacy variable measured.|||days||Inter-Quartile Range|Median
2619864|NCT01959841|Secondary|Time to Pain Resolution|Investigators assessed the pain using NRS. The date of pain resolution is defined as the first day when all NRS scores are rated as 2 or less, and such scores are continuously observed until Day 92 or discontinuation visit.|29days|The full analysis set(FAS).The FAS was defined as patients who were diagnosed with herpes zoster at the time of case registration, who subsequently received the study drugs, and had any efficacy variable measured.|||days||Inter-Quartile Range|Median
2619865|NCT01959841|Secondary|Time to Healing|"We defined the following state as Healing.~A condition where all lesions of erythemas/papulae, vesicles/pustules, and erosions/ulcers have disappeared, and complete disappearance of crusts or complete epithelialization of the base of crusts are considered to have been achieved.~In subjects with no formation of vesicles or pustules, a condition where all lesions of erythemas/papulae have disappeared"|29days|The full analysis set(FAS).The FAS was defined as patients who were diagnosed with herpes zoster at the time of case registration, who subsequently received the study drugs, and had any efficacy variable measured.|||days||Inter-Quartile Range|Median
2620012|NCT01958606|Other Pre-specified|Change in Self-Efficacy and Outcome Expectations for Exercise Scale||Baseline and 4 weeks|Outcome measure not used||||||
2619868|NCT01959841|Primary|The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment|"The investigator assessed the Number of rashes (erythemas/papulae and vesicles/pustules). The new lesion formation was defined as the state in which the number of rashes is increasing."|4days|The full analysis set(FAS).The FAS was defined as patients who were diagnosed with herpes zoster at the time of case registration, who subsequently received the study drugs, and had any efficacy variable measured.|||percentage of Participants|||Number
2619869|NCT01959685|Primary|Cmax of a Single Dose of 250 mg Androxal||24 hours|Safety population|||ng/dL||Standard Deviation|Mean
2619870|NCT01959685|Primary|Pharmacokinetics|Cmax of a single dose 125 mg of Androxal|24 hrs|Safety population|||ng/dL||Standard Deviation|Mean
2619871|NCT01959672|Other Pre-specified|Number of Participants With CA-125-Specific T-cell Signal.|The percentage of patients responding will be summarized using frequencies and percentages.|Baseline to up to week 12||||Participants|||Count of Participants
2619872|NCT01959672|Secondary|Tumor Response Rate, Evaluated on the Pathology Specimen|The percentage of patients responding will be summarized using frequencies and percentages. Define poor, intermediate and good response as follows: Score 1-3: poor response to neoadjuvant therapy (still have majority of cancer at the time of surgery) Score 4-6: intermediate response to neoadjuvant therapy (still have moderate amount of cancer at the time of surgery) Score 7-9: good response to neoadjuvant therapy (have minimal amount of residual cancer at the time of surgery)|Up to week 18||||Participants|||Count of Participants
2619873|NCT01959672|Secondary|Surgical Complete Resection (Negative Margin) Rate|The percentage of patients who will undergo R0 resection|Up to week 18||||Participants|||Count of Participants
2619874|NCT01959672|Secondary|Overall Survival|Analyzed using Kaplan-Meier plots, medians and ranges.|Date of first of study drug to the date of death, assessed up to 5 years||||months||95% Confidence Interval|Median
2619875|NCT01959672|Secondary|Distant Failure-free Survival|Analyzed using Kaplan-Meier plots, medians and ranges.|Date of administration study drug to the date of first appearance of tumor lesions by imaging, or death, assessed up to 5 years||||months||95% Confidence Interval|Median
2619876|NCT01959672|Primary|Number of Participants With Progressive Disease,|Rate of progressive disease defined as at least a 25% increase in the longest diameter of a lesion, taking as reference the longest diameter recorded since the treatment started. An exact one-sided 90% confidence interval will be constructed round the progressive disease rate.|Up to 4 months|Analysis of the primary endpoint (progression at 4 months) demonstrated that of the ten patients who remained alive, two (20%) had progressed at 4 months.|||Participants|||Count of Participants
2619877|NCT01959607|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of THS 2.2, CC and NRT|"T0 = start of single product use.~Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares means are provided."|Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.|||ng*h/mL||95% Confidence Interval|Least Squares Mean
2619878|NCT01959607|Primary|Maximum Concentration (Cmax) of Nicotine Following Single Use of THS 2.2, CC and NRT|"T0 = start of single product use.~Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).~Geometric Least Squares means are provided."|Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0|PK populations consisted of all the randomized subjects who completed at least 1 of the single use days (Days 1 or 3), and for whom at least 1 PK parameter could be derived. Subjects with major protocol deviations that impacted the evaluability of the results were excluded from the PK populations.|||ng/mL||95% Confidence Interval|Least Squares Mean
2619879|NCT01959581|Primary|Change in Time Contacting Objects|Percent of the assessment time participants are able to contact objects across different locations. Change within each session with versus without the exoskeleton donned. Slope of change across time in the intervention phase relative to in the baseline phase.|7 months|infants born with significant brain injury and toddlers with a diagnosis of arthrogryposis multiplex congenita|||percentage of time||Standard Deviation|Mean
2619880|NCT01959529|Secondary|Change in Glycosylated Haemoglobin (HbA1c)|Mean change in HbA1c from week 0 to month 24.|Randomisation to 24 months|The analysis was based on the FAS. The number of subjects analysed are the number of subjects with the available data after 24 months.|||percentage of HbA1c||Standard Deviation|Mean
2619881|NCT01959529|Secondary|Occurrence of at Least One EAC Confirmed Severe Hypoglycaemic Episode Within a Subject (Yes/no)|Occurrence of at least one EAC-confirmed severe hypoglycaemic episode within a subject from week 0 to the last assessment (up to 35.6 months). The episode of severe hypoglycaemia is an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions.|From randomisation to individual end of trial date (maximum patient year observation: 2.75 years)|The analysis was based on the FAS, which included all randomised subjects.|||Participants|||Count of Participants
2619882|NCT01959529|Secondary|Number of EAC-confirmed Severe Hypoglycaemic Episodes|Number of severe hypoglycaemic episodes from week 0 to the last assessment (up to 35.6 months). The episode of severe hypoglycaemia is an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The trial was event driven and planned to last up to a maximum of 60.5 months. The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months. The maximum trial duration for a single subject was 33.1 months.|From randomisation to individual end of trial (maximum patient year observation: 2.75 years)|The analysis was based on the FAS, which included all randomised subjects.|||Number of severe episodes|||Number
2619910|NCT01959243|Secondary|Drop Comfort Assessment as Assessed by the Participant|"Drop comfort assessment (0-10 unit scale in which a score of 0 denotes very comfortable and 10 is very uncomfortable) was performed by the participant. Participant's average score across eyes at each time point were used for analysis."|At dose installation, 30 seconds postdose installation, and 1 minute postdose installation on Day 1|All randomized participants who received at least 1 dose of study drug (Safety Population).|||units on a scale||Standard Deviation|Mean
2619883|NCT01959529|Primary|Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke|Time from randomisation to first occurrence of an event adjudication committee (EAC)-confirmed 3-component major adverse cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction, or nonfatal stroke. Events with EAC-confirmed onset date between randomisation and individual end of trial were included in the analyses. The number of subjects experiencing first EAC-confirmed MACEs, date between randomisation to the end of trial, both days included were presented. The trial was event driven and planned to last up to a maximum of 60.5 months. The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months. The maximum trial duration for a single subject was 33.1 months.|From randomisation to individual end of trial date (maximum patient year observation: 2.75 years)|The analysis was based on the FAS, which included all randomised subjects.|||Participants|||Count of Participants
2619884|NCT01959516|Secondary|Comparison of Glycopyrronium QD Versus Tiotropium QD on Symptoms Outcome|"Comparison of symptoms outcome between glycopyrronium QD versus tiotropium QD will be conducted via the PROMorning COPD Symptoms questionnaire. This questionnaire will be completed by participants at waking-up, pre-inhalation of study treatment (at home), and they will complete Part 2 of PRO-Morning COPD Symptoms questionnaire at site, 3hours post-inhalation of study treatment. The PRO-Morning COPD Symptoms Questionnaire is a self-administered patient reported outcome (PRO) instrument developed by the sponsor to evaluate patients' experience of early morning symptoms of COPD. The questionnaire consists of two parts : predose and postdose.~Each part has 6 questions and for each question a scale of 0 to 10 can be reached. For the predose and postdose part of the questionnaire you will have then each a total score of 0-60 by adding the sub-scores for each question, higher scores represent worse severity of COPD morning symptoms"|day 1 (baseline) and week 4|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and had at least one post-dose value of FEV1|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2619885|NCT01959516|Primary|Forced Expiratory Volume in 1 Second (FEV1) AUC0-4h After First Dose of Treatment.|Forced Expiratory Volume in 1 second (FEV1) Area Under the Curve (AUC) will measured via spirometry and calculated from 0 to 4 hours post-dose on day 1 of study treatment.|Day 1|The intention-to-treat (ITT) population consisted of all randomized patients who received at least one dose of the study treatment and had at least one post-dose value of FEV1|||Liters*hours||95% Confidence Interval|Least Squares Mean
2619886|NCT01959503|Secondary|Proportion of Subjects With Device-Related Serious Adverse Events Following Assigned Treatment Through 30 Days||30 days post procedure|One subject in Progel Vascular Sealant and one subject in Gelfoam Plus discontinue before 30days and do not have device-related SAE. They are considered as not evaluable and are not included in this analysis, thus makes the difference compared to population in baseline.|||participants|||Number
2619887|NCT01959503|Secondary|Incidence of Reoperations for Aortic Bleeding Complications Following Treatment.||30 days post procedure||||participants|||Number
2619888|NCT01959503|Secondary|Time Between Cross Clamp Removal and Request of Surgical Wires for Sternal Closure.||Intra-procedurally|In the Vascular group two subjects were not evaluable as information was not collected for this endpoint, which changes the number from 106 to 104, compare to baseline characteristics.|||minutes||Standard Deviation|Mean
2619889|NCT01959503|Secondary|Proportion of Subjects Who Received Transfusion Within 24 Hours Following Surgery||24 hours post procedure|In the Gelfoam Plus group one subject was not evaluable as information was not collected for this endpoint, which change the number from 50 to 49, compare to baseline characteristics.|||participants|||Number
2619890|NCT01959503|Secondary|Chest Tube Drainage Volume Following Surgery.||24 hours post procedure|In the Gelfoam Plus group one subject was not evaluable as information was not collected for this endpoint, which change the number from 50 to 49, compare to baseline characteristics.|||mL||Standard Deviation|Mean
2619891|NCT01959503|Secondary|Proportion of Subjects Who Achieve Immediate Hemostasis, Defined as 0 Seconds, at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.||0 seconds to 10 minutes||||percentage of participants|||Number
2619892|NCT01959503|Secondary|Proportion of Subjects Who Achieve Successful Hemostasis at All Treated Aortic Anastomotic Suture Lines Following Assigned Treatment.||5 minutes after application|In the Progel group one subject was not evaluable as information was not collected for this endpoint, which change the number from 106 to 105, compare to baseline characteristics.|||percentage of participants|||Number
2619893|NCT01959503|Primary|Time to Achieve Hemostasis at the Aortic Anastomotic Suture Line From the Time Surgical Clamps Are Released to Cessation of Leakage at the Treated Anastomotic Site With Either Progel or Gelfoam.||0 seconds to 600 seconds|In the Progel group one subject was not evaluable as information was not collected for the primary end-point changing the number from 106 to 105, compare to baseline characteristics.|||seconds||Standard Deviation|Mean
2619894|NCT01959490|Other Pre-specified|Descriptive Statistics of PET/CT Scan|Qualitative and quantitative image analysis will be performed and descriptively summarized. For the 10 patients in the PET/CT sub-study of cohort 1.|Up to 30 days after last cycle of treatment|Outcome not determined because low accrual prevented appropriate analysis and calculation of the prediction measure.||||||
2619895|NCT01959490|Secondary|"The Number of Patients With a pCR Predicted by Changes in Texture on Breast DCE-MRI After a Two-week run-in Treatment With Trastuzumab, Pertuzumab, or Bevacizumab"|Determine if changes in regularity and entropy range predict pCR and in an exploratory fashion determine if specific texture features exist in each molecular subtype that predict pCR.|At 2 weeks after start of run-in period|Data not collected||||||
2619896|NCT01959490|Secondary|The Number of Patients With a pCR Predicated by Copy Number Alterations.||Up to 30 days after last cycle of treatment|Data not collected||||||
2619897|NCT01959490|Secondary|The Number of HER2 Positive Patients With a pCR Predicted by the AKT Signature and IGF Signature.||Up to 30 days after last cycle of treatment|Data not collected||||||
2619898|NCT01959490|Secondary|The Number of HER2 Negative Patients With a pCR Predicted by the TGF-B Response Signature||Up to 30 days after last cycle of treatment|Data not collected||||||
2619899|NCT01959490|Secondary|The Number of HER2 Positive Patients With a Pathological Complete Response (pCR) Predicted by a Trastuzumab and Pertuzumab Response Signature||Up to 30 days after last cycle of treatment|Data not collected||||||
2619900|NCT01959490|Primary|Number of Patients With a Pathological Complete Response (pCR) Who Received Targeted Therapy With Trastuzumab and Pertuzumab or Bevacizumab Predicted by Genomically-derived Molecular Subtypes.|Number of patients with a pathological complete response (pCR) who received targeted therapy with trastuzumab and pertuzumab or bevacizumab predicted by genomically-derived molecular subtypes (HER2 positive or HER2 negative. pCR is defined as absence of invasive cancer in breast or lymph nodes after neoadjuvant chemotherapy.|Up to 30 days after last cycle of treatment|All participants enrolled in study and who received treatment.|||Participants|||Count of Participants
2619901|NCT01959412|Secondary|Change From Period Baseline in FVC (L) AUC (0-24h)|Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.|Day 1 (24 hours)|The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables|||Liters||Standard Error|Least Squares Mean
2619902|NCT01959412|Secondary|Change From Period Baseline in Trough FEV1 (L)|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 is defined as the mean of two measurements at different time points.|Day 1 (24 hours)|The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables|||Liters||Standard Error|Least Squares Mean
2619903|NCT01959412|Secondary|Change From Period Baseline in Peak FEV1 (L)|Spirometry will be conducted according to internationally accepted standards. Peak Forced Expiratory Volume in 1 second (FEV1) is the maximum FEV1 recorded between different time points.|Day 1 (24 hours)|The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables|||Liters||Standard Error|Least Squares Mean
2619904|NCT01959412|Secondary|Change From Period Baseline in FEV1 (L) AUC(0-12h) and FEV1 (L) AUC(12- 24h)|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 12 hours post-dose period.|Day 1 (12 hours)|The Full Analysis Set (FAS) consisted of all patients in the RAN who received at least 1 dose of study drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables|||liters||Standard Error|Least Squares Mean
2619905|NCT01959412|Primary|Change From Period Baseline in FEV1 (L) AUC(0-24h)|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured pre-dose and over a 24 hours post-dose period.|Day 1 (24 hours)|drug. Following the intent-to-treat principle, data for patients in the FAS were analyzed according to the treatment they were randomized to in the assigned treatment sequence. The FAS was used in the analysis of all efficacy variables|||Liters||Standard Error|Least Squares Mean
2619906|NCT01959334|Primary|Number of Participants With At Least One Adverse Event|"Safety parameters assessed included the occurrence of adverse events, the measurement of clinical laboratory parameters; vital signs, ECGs, physical examination, blood glucose, and examination of the injection site (following the IM administration). An AE was defined as any untoward medical occurrence in a clinical investigation subject administered the investigational product and which did not necessarily have a causal relationship with this treatment~A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section."|First dose of study drug through the post-study completion (up to 10 weeks)|Participants who received at least one dose of glucagon (IM or NG).|||Participants|||Count of Participants
2619907|NCT01959334|Primary|Percentage of Participants With Neutralizing Antibodies||Baseline through study completion (up to 10 weeks)|All enrolled participants who received at least 1 dose of study drug and either had baseline and at least 1 post-baseline evaluable samples or had no evaluable baseline and all negative post-baseline anti-drug antibody negative samples.|||percentage of participants|||Number
2619908|NCT01959334|Primary|Percentage of Participants With Treatment-emergent Anti-Drug Antibody (ADA)|Glucagon anti-drug antibodies (ADA) were assessed at baseline through study completion. Percentage of participants (Pts) with ADA=(number of Pts with treatment-emergent ADA/number of Pts assessed)*100. Treatment-Emergent ADA includes treatment-induced ADA and treatment boosted ADA. Treatment-induced is defined as participants with 'Not Detected' ADA at baseline (drug-naive) and at least one post-baseline ADA 'Detected' sample with a corresponding titer that is one 2-fold dilution higher than the MRD (minimal required dilution) of the assay. For the nasal glucagon Tier 1-3 ADA screening assay, the MRD is 1:20. Treatment-boosted is defined as Patient with ADA 'Detected' at baseline (drug-naive) and at least one post-baseline ADA 'Detected' sample with a corresponding titer that is at least (>or=) 4-fold higher than the baseline titer.|Baseline through study completion (up to 10 weeks)|All enrolled participants who received at least 1 dose of study drug with an evaluable baseline ADA result and a post-baseline ADA result.|||percentage of participants|||Number
2619909|NCT01959243|Secondary|Number of Participants Who Were Fully Alert as Assessed by the Investigator on Days 1, 8, 15, and 29|An alertness evaluation was performed by the Investigator asking the participant and/or participant's parent/legal guardian (pediatric participants only) a few questions based on the previous week. Using those answers, along with his/her clinical opinion, the Investigator made an assessment of the participant's level of alertness using the following 6-point scale: fully alert, alert, lethargy, obtunded, stupor, or coma.|Predose installation on Day 1 and 90-180 minutes postdose installation on Days 1, 8, 15, and 29|All randomized participants who received at least 1 dose of study drug (Safety Population) with evaluable alertness data.|||Participants|||Count of Participants
2620013|NCT01958606|Secondary|Change in Fractional Utilization|Metabolic cost of gait as a percentage of aerobic capacity|Baseline and 4 weeks|Subjects with available data|||percentage of aerobic capacity||95% Confidence Interval|Mean
2619911|NCT01959243|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|TEAE is defined as any untoward medical occurrence or undesirable event(s) that begins or worsens following administration of the study drug, whether or not considered related to the treatment by the Investigator. A TEAE is considered serious if, in the view of the Investigator or Sponsor, it results in any of the following outcomes: death, a life-threatening TEAE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, an important medical event that jeopardized the participant and required medical intervention, or sight-threatening (possibly resulting in persistent or significant loss of vision). A summary of other non-serious adverse events (AEs) and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to Day 29|All randomized participants who received at least 1 dose of study drug (Safety Population).|||Participants|||Count of Participants
2619912|NCT01959230|Secondary|Change From Predose Ocular Redness Score as Measured by the Investigator Using the Ora Calibra Ocular Hyperemia Scale|Ocular redness using the Ora Calibra Ocular Hyperemia Scale was scored by the Investigator using the following scale (allowing half unit increments): 0=None; 1.0=Mild-Slightly dilated blood vessels, color of vessels is typically pink, can be quadrantal; 2.0=Moderate-More apparent dilation of blood vessels, vessel color is more intense (redder), involves the majority of the vessel bed; 3.0=Severe-Numerous and obvious dilated blood vessels, in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4.0=Extremely Severe-Large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed. A lower score is indicative of less redness.|0 (predose), 1, 360, and 480 minutes (min) postdose on Day 1 and 0 (predose), 1, and 5 min postdose on Days 15 and 29|All randomized participants who received at least 1 dose of study drug and completed at least 1 post instillation ocular redness evaluation at Baseline (ITT Population) with evaluable Investigator-recorded ocular redness data.|||units on a scale||Standard Deviation|Mean
2619913|NCT01959230|Secondary|Ocular Redness as Measured by the Participant|Ocular redness was scored daily pre-dose and post-dose on Days 1 to 29 and scored daily on Days 30 to 36 by the participant using a 0 to 4 unit scale (not allowing half unit increments). A lower score was indicative of less redness. The LOCF method used for this Secondary Outcome Measure was for imputing missing daily post-dose mean scores for entire days. If ≥1 score was provided for a day, imputation was not done. Imputation was done within the dosing period and separately within the follow-up period. The average (mean) daily pre-dose and post-dose scores for the dosing period Day 1 to Day 15 and dosing period Day 15 to Day 29, and the average (mean) daily score for the follow-up period Day 29 to Day 36 are reported.|Day 1 to Day 15; Day 15 to Day 29; Day 29 to Day 36|All randomized participants who received at least 1 dose of study drug and completed at least 1 post instillation ocular redness evaluation at Baseline (ITT Population) with evaluable participant-recorded ocular redness data. LOCF method used as described in the Outcome Measure Description.|||units on a scale||Standard Deviation|Mean
2619914|NCT01959230|Primary|Ocular Redness as Measured by the Investigator Using the Ora Calibra™ Ocular Hyperemia Scale|Ocular redness using the Ora Calibra Ocular Hyperemia Scale was scored by the Investigator using the following scale (allowing half unit increments): 0=None; 1.0=Mild-Slightly dilated blood vessels, color of vessels is typically pink, can be quadrantal; 2.0=Moderate-More apparent dilation of blood vessels, vessel color is more intense (redder), involves the majority of the vessel bed; 3.0=Severe-Numerous and obvious dilated blood vessels, in the absence of chemosis the color is deep red, may be less red or pink in presence of chemosis, is not quadrantic; 4.0=Extremely Severe-Large, numerous, dilated blood vessels characterized by unusually severe deep red color, regardless of grade of chemosis, which involves the entire vessel bed. A lower score is indicative of less redness.|0 (predose), 5, 15, 30, 60, 90, 120, 180, and 240 minutes postdose on Day 1|All randomized participants who received at least 1 dose of study drug and completed at least 1 post instillation ocular redness evaluation at Baseline (Intent-to-Treat [ITT] Population). Last Observation Carried Forward (LOCF) was used to impute missing data.|||units on a scale||Standard Deviation|Mean
2619915|NCT01959165|Secondary|Number of Participants With Response at Week 12|Response at Week 12 was assessed by Partial Mayo Score. Response was defined as reduction by 2 or more points and 25% in Partial Mayo Score compared to baseline.|12 weeks|All randomised participants who received at least one dose of investigational drug during the double-blind phase|||Participants|||Count of Participants
2619916|NCT01959165|Secondary|Number of Participants With Mucosal Healing at Week 8|Mucosal healing was defined as an absolute Mayo subscore for rectosigmoidoscopy of 0 or 1.|8 weeks|All randomised participants who received at least one dose of investigational drug during the double-blind phase|||Participants|||Count of Participants
2619917|NCT01959165|Secondary|Number of Participants With Response at Week 8|Response at Week 8 was assessed by total Mayo score. Response was defined as decrease 3 points or more and 30 percents in total Mayo score compared to baseline, and with an accompanying decrease in the subscore for rectal bleeding of 1 point or more, or with an absolute subscore for rectal bleeding of 0 or 1.|8 weeks|All randomised participants who received at least one dose of investigational drug during the double-blind phase|||Participants|||Count of Participants
2619918|NCT01959165|Primary|Number of Participants With Remission at Week 8|Remission at Week 8 was defined as a total Mayo score 2 points or smaller, and with no individual subscore more than 1 point.|8 weeks|All randomised participants who received at least one dose of investigational drug during the double-blind phase|||Participants|||Count of Participants
2619919|NCT01959139|Other Pre-specified|Tumor Expression of HA||Within 2 years of end of study|||||||
2619920|NCT01959139|Other Pre-specified|Plasma Expression of Hyaluronan (HA)||Within 2 years of end of study|||||||
2619921|NCT01959139|Other Pre-specified|Cancer Antigen (CA) 19-9 Levels|Explore correlation of maximum decrease in CA 19-9 levels to maximum decrease in CA 19-9 levels with overall survival, progression-free survival and response.|Within 2 years of the end of the study|||||||
2619959|NCT01958918|Primary|Mean of the Absolute Values of CSRT Difference Month 3 to Month 6|The thickness of the retina was measured by Spectral Domain Optical Coherence Topography (SD-OCT). The mean of the absolute values of the CSRT difference between Month 3 and 4, Month 4 and 5, and Month 5 and 6 was calculated (ie, CSRT fluctuation). A lower average CSRT fluctuation demonstrates greater retinal stability. One eye (study eye) contributed to the analysis.|Month 3, Month 4, Month 5, Month 6|FAS. Number analyzed is the number of patients with a measurement|||micrometers||Standard Error|Mean
2619922|NCT01959139|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|"Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.~Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living e.g. bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.~Grade 4: Life-threatening consequences; urgent intervention indicated.~Grade 5: Death related to adverse event"|Duration of treatment and follow up until death or 3 years post registration|Patients who received at least one dose of protocol treatment. Only 105 participants in the phase II trial were assessed for AEs, as 6 participants did not receive protocol treatment.|||Participants|||Number
2619923|NCT01959139|Secondary|Objective Tumor Response Rate (Confirmed and Unconfirmed, Complete and Partial)|"Objective tumor response rate (complete response, unconfirmed complete response, partial response, unconfirmed partial response) in patients with measurable disease were assessed in each arm and compared between arms using Chi-squared test.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions"|Up to 3 years|Participants with measurable disease|||percent of participants||95% Confidence Interval|Number
2619924|NCT01959139|Secondary|Progression Free Survival (PFS) (Phase II)|Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause. Participants last known to be alive without report of progression are censored at date of last contact.|From date of registration to date of death due to any cause, assessed up to 3 years|Eligible and analyzable participants|||months||95% Confidence Interval|Median
2619925|NCT01959139|Primary|Phase II: Overall Survival|"Time from date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact.~Assessed using the logrank test."|From date of registration to date of death due to any cause, assessed up to 3 years|Eligible and analyzable participants|||months||95% Confidence Interval|Median
2619926|NCT01959139|Primary|Phase I: Maximum Tolerated Dose (MTD) of PEGPH20 in Combination With mFOLFIRINOX|"Assess safety of mFOLFIRINOX in combination with PEGPH20 and select the optimal dose of PEGPH20 for the Phase II portion.~MTD of PEGPH20 in combination with mFOLFORINOX was evaluated by testing decreasing doses of PEGPH20 from 3mcg/kg on Day 1 and Day 3/4, to 3mcg/kg on Day 1 only and to 1.6 mcg/kg on Day 1 only.~MTD reflects the highest dose that had a dose-limiting toxicity (DLT) rate of ≤ 17%. DLTs were defined as treatment regimen related: grade ≥ 3 non-hematologic toxicity; grade 4 absolute neutrophil count (ANC) anemia or thrombocytopenia; grade 4 ANC lasting > 7 days; grade ≥ 3 febrile neutropenia; grade ≥ 3 elevation of aspartate aminotransferase (AST)/alanine aminotransferase (ALT), total bilirubin, and creatinine; delay in starting the 2nd cycle of mFOLFIRINOX by > 2 weeks due to drug related toxicity.~DLT were graded using the NCI CTCAE version 4. Note: the third and lowest dose level was not reached."|2 cycles of 14 days|All analyzable patients who experienced a dose limiting toxicity attributable to PEGPH20 and/or mFOLFIRINOX in the first cycle|||ug/kg|||Number
2619927|NCT01959048|Secondary|Morbidity|immediate colonoscopy-related complications, secondary infection|1 weeks||||Participants|||Count of Participants
2619928|NCT01959048|Secondary|Need for Colectomy|Number of Participants who undergo colectomy due to CDAD|30 days||||Participants|||Count of Participants
2619929|NCT01959048|Secondary|All Cause Mortality||30 days||||Participants|||Count of Participants
2619930|NCT01959048|Primary|Number of Participants With Relapse of CDAD|Number of Participants with evidence of relapse of C. diff. associated diarrhea|2 weeks||||Participants|||Count of Participants
2619931|NCT01959048|Primary|Number of Participants With Resolution of Severe CDAD|Resolution of diarrhea, time to decrease in elevated WBC count|2 weeks||||participants|||Number
2619932|NCT01959035|Secondary|Patients Categorised As Sexually Dysfunctional Measured at Week 12 on the ASEX Scale|"The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient's recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction). The presence of sexual dysfunction based on the ASEX scale was defined as an ASEX total score of ≥19, or a score of ≥5 on any item, or a score of ≥4 on any 3 items."|Week 12|This analysis is based on all patients who received at least one dose of IMP in Study 14724B (APTS). At Week 12, the analysis for the number of patients categorised as sexually dysfunctional was based on the 82 patients who had a measure for this outcome|||participants|||Number
2619933|NCT01959035|Secondary|Change From Baseline to Week 12 in ASEX Total Score|"The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient's recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction)."|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for ASEX total score was based on the 82 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
2619941|NCT01959035|Secondary|Change From Baseline to Week 12 in CGI-S Score|Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for CGI-S score was based on the 83 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
2620014|NCT01958606|Secondary|Change in Fastest Treadmill Speed (Steep Ramp Test)|fastest safe treadmill walking speed|Baseline and 4 weeks||||meters per second||95% Confidence Interval|Mean
2619934|NCT01959035|Secondary|Change From Baseline to Week 12 in the WoRQ Total Score|The Readiness for Work Questionnaire (WoRQ) is a clinician-rated scale designed to measure a schizophrenic patient's ability to work. The WoRQ consists of 8 items: the clinician had to rate 7 statements and answer 1 question. The statements were rated on a four-point scale, from 'strongly agree', 'agree', 'disagree' or 'strongly disagree' based on all material available (for example, personal notes, medical records, input from other health professionals, family members or caregivers); and in the final item, the clinician had to indicate if the patient was ready for work or not (by indicating either 'yes' or 'no'). Possible total scores range from 4 to 28. Lower WoRQ total scores indicate better functioning.|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for WoRQ total score was based on the 82 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
2619935|NCT01959035|Secondary|Change From Baseline to Week 12 in the TooL Total Score|Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for TooL total score was based on the 82 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
2619936|NCT01959035|Secondary|Change From Baseline to Week 12 in the 'Instrumental Role' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Instrumental Role' QLS domain score was based on the 81 patients who had a measure for this outcome|||units on a scale||Standard Deviation|Mean
2619937|NCT01959035|Secondary|Change From Baseline to Week 12 in the 'Interpersonal Relations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Interpersonal Relations' QLS domain score was based on the 82 patients who had a measure for this outcome|||units on a scale||Standard Deviation|Mean
2619938|NCT01959035|Secondary|Change From Baseline to Week 12 in the 'Intrapsychic Foundations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Intrapsychic Foundations' QLS domain score was based on the 82 patients who had a measure for this outcome|||units on a scale||Standard Deviation|Mean
2619939|NCT01959035|Secondary|Change From Baseline to Week 12 in the 'Common Objects and Activities' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for 'Common Objects and Activities' QLS domain score was based on the 82 patients who had a measure for this outcome|||units on a scale||Standard Deviation|Mean
2619940|NCT01959035|Secondary|Change From Baseline to Week 12 in QLS Total Score|The Quality of Life Scale (QLS) is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for QLS total score was based on the 82 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
2619942|NCT01959035|Secondary|Change From Baseline to Week 12 in SWN-S Total Score|The Subjective Well-Being under Neuroleptic Treatment - Short Version (SWN-S) is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.|Baseline and Week 12|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 12, the analysis for SWN-S total score was based on the 82 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
2619943|NCT01959035|Secondary|Patients Categorised As Sexually Dysfunctional Measured at Week 24 on the ASEX Scale|"The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient's recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction). The presence of sexual dysfunction based on the ASEX scale was defined as an ASEX total score of ≥19, or a score of ≥5 on any item, or a score of ≥4 on any 3 items."|Week 24|This analysis is based on all patients who received at least one dose of IMP in Study 14724B (APTS). At Week 24, the analysis for the number of patients categorised as sexually dysfunctional was based on the 75 patients who had a measure for this outcome|||participants|||Number
2619944|NCT01959035|Secondary|Change From Baseline to Week 24 in ASEX Total Score|"The Arizona Sexual Experience Scale (ASEX) is a five-item, patient-rated scale that evaluates a patient's recent sexual experiences. The ASEX is used to identify individuals with sexual dysfunction. Patients were asked to assess their own experiences over the last week (for example, How strong is your sex drive?, Are your orgasms satisfying?) and respond on a six-point scale for each item. Possible total scores range from 5 to 30. Higher ASEX total scores indicate more sexual dysfunction (hypofunction)."|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for ASEX total score was based on the 75 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
2619945|NCT01959035|Secondary|Change From Baseline to Week 24 in the WoRQ Total Score|The Readiness for Work Questionnaire (WoRQ) is a clinician-rated scale designed to measure a schizophrenic patient's ability to work. The WoRQ consists of 8 items: the clinician had to rate 7 statements and answer 1 question. The statements were rated on a four-point scale, from 'strongly agree', 'agree', 'disagree' or 'strongly disagree' based on all material available (for example, personal notes, medical records, input from other health professionals, family members or caregivers); and in the final item, the clinician had to indicate if the patient was ready for work or not (by indicating either 'yes' or 'no'). Possible total scores range from 4 to 28. Lower WoRQ total scores indicate better functioning.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for WoRQ total score was based on the 77 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
2619946|NCT01959035|Secondary|Change From Baseline to Week 24 in the TooL Total Score|Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for TooL total score was based on the 75 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
2619947|NCT01959035|Secondary|Change From Baseline to Week 24 in the 'Instrumental Role' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for 'Instrumental Role' QLS domain score was based on the 78 patients who had a measure for this outcome|||units on a scale||Standard Deviation|Mean
2619948|NCT01959035|Secondary|Change From Baseline to Week 24 in the 'Interpersonal Relations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for 'Interpersonal Relations' QLS domain score was based on the 78 patients who had a measure for this outcome|||units on a scale||Standard Deviation|Mean
2620005|NCT01958606|Other Pre-specified|Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 12|Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition|Before and after training session 12|measure not used||||||
2619949|NCT01959035|Secondary|Change From Baseline to Week 24 in the 'Intrapsychic Foundations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for 'Intrapsychic Foundations' QLS domain score was based on the 78 patients who had a measure for this outcome|||units on a scale||Standard Deviation|Mean
2619950|NCT01959035|Secondary|Change From Baseline to Week 24 in the 'Common Objects and Activities' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for 'Common Objects and Activities' QLS domain score was based 78 patients who had a measure for this outcome|||units on a scale||Standard Deviation|Mean
2619951|NCT01959035|Secondary|Change From Baseline to Week 24 in QLS Total Score|The Quality of Life Scale (QLS) is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for QLS total score was based on the 78 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
2619952|NCT01959035|Secondary|Change From Baseline to Week 24 in CGI-S Score|Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for CGI-S score was based on the 78 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
2619953|NCT01959035|Secondary|Change From Baseline to Week 24 in SWN-S Total Score|The Subjective Well-Being under Neuroleptic Treatment - Short Version (SWN-S) is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.|Baseline and Week 24|Effectiveness data is based on all patients who received at least one dose of IMP in Study 14724B (APTS). Effectiveness was measured at Weeks 0, 12, and 24. At Week 24, the analysis for SWN-S total score was based on the 75 patients who had a measure for this outcome|||units on a scale||95% Confidence Interval|Least Squares Mean
2619954|NCT01959035|Primary|Safety and Tolerability|Number of treatment emergent adverse events (TEAEs).|Up to 24 weeks and 4-week safety follow up|Safety data is based on all patients who received at least one dose of investigational medicinal product (IMP) in Study 14724B.|||number of events|||Number
2619955|NCT01958918|Secondary|Correlations Between CSRT Fluctuation (Month 3 to 6) and Functional Outcomes at Month 12 (Full Analysis Set)|Correlation coefficient calculated based on Pearson's correlation between each corresponding parameter and CSRT stability.|Month 3 to Month 6, Month 12|Full Analysis Set with measure. No statistical analysis was performed.|||correlation coefficient|||Number
2619956|NCT01958918|Secondary|National Eye Institute Visual Functioning Questionnaire Composite Score (VFQ-25) at Month 12|Vision-related quality of life was assessed by the patient using the National Eye Institute Visual Function Questionnaire. The scores of 12 subscales (general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision) were added together for a total (composite) score, which ranged from 0 to 100. A higher score indicates poorer function.|Month 12|FAS with measurement at Month 12. No statistical analysis was performed.|||units on a scale||Standard Deviation|Mean
2619957|NCT01958918|Secondary|IREST at Month 12|Number of incorrectly read words (IREST) was assessed using International Reading Speed Texts (IResT) and measured in words per minute.|Month 12|FAS with measurement at Month 12. No statistical analysis was performed.|||incorrect words per minute||Standard Deviation|Mean
2619958|NCT01958918|Secondary|Total Best Corrected Visual Acuity (BCVA) Score Measured in ETDRS Letters at Month 12|Visual acuity was assessed in a sitting position with refraction using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. A higher score indicates better visual acuity. ETDRS scale ranges from 0-100 letters. A score of 65 to 70 letters represents a low to moderate visual acuity|Month 12|FAS with measurement at visit Month 12. No statistical analysis was performed.|||letters||Standard Deviation|Mean
2619960|NCT01958827|Secondary|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either Reasonable possibility or No reasonable possibility of being related to study drug.~For more details on adverse events please see the AE section below."|60 weeks|Safety Analysis Set|||participants|||Number
2619961|NCT01958827|Secondary|Body Temperature: Mean Change From Baseline (Week 0) to Each Visit|n=the number of participants with available data at each time point.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Safety Analysis Set|||degrees Celcius||Standard Deviation|Mean
2619962|NCT01958827|Secondary|Heart Rate: Mean Change From Baseline (Week 0) to Each Visit|Heart rate was measured while the participant was sitting. n=the number of participants with available data at each time point.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Safety Analysis Set|||bpm||Standard Deviation|Mean
2619963|NCT01958827|Secondary|Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit|Blood pressure was measured while the participant was sitting. n=the number of participants with available data at each time point.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Safety Analysis Set|||mm Hg||Standard Deviation|Mean
2619964|NCT01958827|Secondary|Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit|Blood pressure was measured while the participant was sitting. n=the number of participants with available data at each time point.|Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Safety Analysis Set|||mm Hg||Standard Deviation|Mean
2619965|NCT01958827|Secondary|Number of Participants With Potentially Significant Clinical Chemistry Parameters|Blood was collected for analysis at designated study visits; chemistry results were provided by a central laboratory. The number of participants with an abnormal laboratory result (higher than upper limit of normal [ULN] or lower than lower limit of normal [LLN]) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized. n=the number of participants with CTC Grade <3 at baseline and a post-baseline value for each parameter.|52 weeks|Safety Analysis Set|||participants|||Number
2619966|NCT01958827|Secondary|Number of Participants With Potentially Significant Hematology Parameters|Blood was collected for analysis at designated study visits; hematology results were provided by each site laboratory. The number of participants with an abnormal laboratory result (higher than upper limit of normal [ULN] or lower than lower limit of normal [LLN]) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized. Increase is signified by ↑. n=the number of participants with CTC Grade <3 at baseline and a post-baseline value.|52 weeks|Safety Analysis Set: All enrolled participants who received at least one dose of study drug.|||participants|||Number
2619967|NCT01958827|Other Pre-specified|Change in Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 52|Serum samples with adalimumab concentration below 2 μg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 20 ng/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose.|Baseline (Week 0) to Week 52|FAS|||participants|||Number
2619968|NCT01958827|Other Pre-specified|Change in Mean Serum Adalimumab Concentration From Baseline (Week 0) to Week 52|Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated heterogeneous electrochemiluminescence (ECL)-immunoassay method. The assay captures adalimumab via biotinylated anti-idiotypic antibody, and detects it via sulfo-tagged TNF-alpha. n=the number of participants with available data at each time point.|Baseline (Week 0) to Week 52|All participants in the FAS with available data at both time points.|||µg/mL||Standard Deviation|Mean
2619969|NCT01958827|Secondary|C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52|C-reactive protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 0.3 mg/dL, slightly increasing with age. Last Observation Carried Forward (LOCF) was used for missing data.|Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS|||mg/dL||Standard Deviation|Mean
2619970|NCT01958827|Secondary|Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS|||percentage of participants||95% Confidence Interval|Number
2619971|NCT01958827|Secondary|Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS|||percentage of participants||95% Confidence Interval|Number
2619972|NCT01958827|Secondary|Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used. Week 8 was the primary outcome measure.|Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS|||percentage of participants||95% Confidence Interval|Number
2620006|NCT01958606|Other Pre-specified|Change in Transcranial Magnetic Stimulation (TMS) Responses Associated With Training Session 2|Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition|Before and after training session 2|measure not used||||||
2619973|NCT01958827|Secondary|Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|FAS|||percentage of participants||95% Confidence Interval|Number
2619974|NCT01958827|Primary|Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8|CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.|Week 8|Full Analysis Set (FAS): All enrolled participants who received at least one dose of study drug and had at least one post-treatment efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
2619975|NCT01958788|Secondary|Beck Depression Inventory, 2nd Edition (BDI-II)|The BDI-II is a self-report questionnaire assessing a variety of depressive symptoms, including low mood, anhedonia, and worthlessness. Scores range from 0 to 63, with greater scores indicating greater depressive symptoms. The BDI-II was used to evaluate change from baseline in self-reported depressive symptoms.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up||||units on a scale||Standard Deviation|Mean
2619976|NCT01958788|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self-report questionnaire assessing affective, cognitive, and somatic anxiety over the preceding week. Scores range from 0 to 63, with greater scores representing greater self-reported anxiety. The BAI was used to evaluate change from baseline in self-reported anxiety.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up||||units on a scale||Standard Deviation|Mean
2619977|NCT01958788|Secondary|GAD Safety Behaviours Questionnaire (GAD-SBQ)|The GAD-SBQ is a self-report questionnaire assessing the tendency to use safety behaviours to cope with anxiety, such as reassurance-seeking and overpreparation. Scores range from 18 to 90, with greater scores indicating greater use of safety behaviours. The GA-SBQ was used to evaluate change from baseline in self-reported safety behaviours.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up||||units on a scale||Standard Deviation|Mean
2619978|NCT01958788|Secondary|Penn State Worry Questionnaire (PSWQ)|The PSWQ is a self-report questionnaire assessing excessive and uncontrollable worry. Scores range from 16 to 80, with greater scores indicating greater worry. The PSWQ was used to evaluate change from baseline in self-reported worry.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up||||units on a scale||Standard Deviation|Mean
2619979|NCT01958788|Secondary|Intolerance of Uncertainty Scale (IUS)|The IUS is a self-report questionnaire assessing intolerance of uncertainty, or the tendency to view uncertainty and its consequences as negative. Scores range from 27 to 135, with higher scores representing greater intolerance of uncertainty. The IUS was used to assess change from baseline in self-reported intolerance of uncertainty.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up||||units on a scale||Standard Deviation|Mean
2619980|NCT01958788|Secondary|Worry and Anxiety Questionnaire (WAQ)|The WAQ is a questionnaire assessing self-reported symptoms of GAD. Scores range from 0 to 56, with higher scores indicating greater severity of self-rated GAD symptoms. The measure was used to assess change from baseline in self-reported GAD symptoms (WAQ).|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up||||units on a scale||Standard Deviation|Mean
2619981|NCT01958788|Primary|Clinician's Severity Rating (CSR) Scale of Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV)|The CSR is a severity rating scale ranging from 0-8. Scores of 4 or greater represent clinically significant symptoms, whereas scores lower than 4 indicate subclinical symptoms. Lower scores represent improved outcome. This measure was used to evaluate change from baseline in the severity of GAD symptoms as assessed by the ADIS-IV, a semi-structured clinical interview for Axis I disorders.|Pretreatment to posttreatment (12 weeks) and 6-month Follow-Up||||units on a scale||Standard Deviation|Mean
2619982|NCT01958671|Secondary|Change From Baseline in DBP at Week 26|The change from baseline is the Week 26 DBP minus the Week 0 DBP. Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline DBP measurement or at least 1 post-randomization DBP measurement subsequent to at least 1 dose of study treatment.|||mmHg||95% Confidence Interval|Least Squares Mean
2619983|NCT01958671|Secondary|Baseline Sitting Diastolic Blood Pressure (DBP)|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Change from baseline in DBP at Week 26 data are presented in the following outcome measure.|Baseline|Analysis population consisted of all randomized participants who had a baseline DBP measurement.|||mmHg||Standard Deviation|Mean
2619984|NCT01958671|Secondary|Change From Baseline in SBP at Week 26|The change from baseline is the Week 26 SBP minus the Week 0 SBP. Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline SBP measurement or at least 1 post-randomization SBP measurement subsequent to at least 1 dose of study treatment.|||mmHg||95% Confidence Interval|Least Squares Mean
2619985|NCT01958671|Secondary|Baseline Sitting Systolic Blood Pressure (SBP)|Sitting blood pressure was measured in triplicate and the average of the measurements taken at a single assessment time was analyzed. Change from baseline in SBP at Week 26 data are presented in the following outcome measure.|Baseline|Analysis population consisted of all randomized participants who had a baseline SBP measurement.|||mmHg||Standard Deviation|Mean
2619986|NCT01958671|Secondary|Change From Baseline in 2-hr PPG at Week 26|The change from baseline is the Week 26 2-hr PPG minus the Week 0 2-hr PPG. Laboratory measurements were performed 120 minutes following the start of the administration of the meal for the MMTT. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline 2-hr PPG measurement or at least 1 post-randomization 2-hr PPG measurement subsequent to at least 1 dose of study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
2619987|NCT01958671|Secondary|Baseline 2-hour Post-prandial Glucose (2-hr PPG) Level|Laboratory measurements were performed 120 minutes following the start of the administration of the meal for the Mixed Meal Tolerance Test (MMTT). Change from baseline in 2-hr PPG level at Week 26 data are presented in the following outcome measure.|Baseline|Analysis population consisted of all randomized participants who had a baseline 2-hr PPG measurement.|||mg/dL||Standard Deviation|Mean
2619988|NCT01958671|Secondary|Percentage of Participants With A1C <7% (<53 mmol/Mol) at Week 26|A1C is measured as percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline A1C measurement or at least 1 post-randomization A1C measurement subsequent to at least 1 dose of study treatment.|||Percentage of participants|||Number
2619989|NCT01958671|Secondary|Change From Baseline in Body Weight at Week 26|The change from baseline is the Week 26 body weight minus the Week 0 body weight. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline body weight measurement or at least 1 post-randomization body weight measurement subsequent to at least 1 dose of study treatment.|||Kilograms||95% Confidence Interval|Least Squares Mean
2619990|NCT01958671|Secondary|Change From Baseline in FPG at Week 26|The change from baseline is the Week 26 FPG minus the Week 0 FPG. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of glycemic rescue therapy.|Baseline and Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline FPG measurement or at least 1 post-randomization FPG measurement subsequent to at least 1 dose of study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
2619991|NCT01958671|Primary|Percentage of Participants Discontinuing Study Treatment Due to an AE|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.|Up to 52 weeks|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment. Participants were classified according to randomized treatment.|||Percentage of participants|||Number
2619992|NCT01958671|Primary|Percentage of Participants Experiencing An Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.|Up to 54 weeks (including 2 weeks following last dose)|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment. Participants were classified according to randomized treatment.|||Percentage of participants|||Number
2619993|NCT01958671|Primary|Change From Baseline In A1C at Week 26|A1C is measured as percent. The change from baseline is the Week 26 A1C percent minus the Week 0 A1C percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.|Baseline and Week 26|Analysis population consisted of all randomized participants who received at least 1 dose of study treatment and had a baseline A1C measurement or at least 1 post-randomization A1C measurement subsequent to at least 1 dose of study treatment.|||Percent||95% Confidence Interval|Least Squares Mean
2619994|NCT01958645|Secondary|Change From Baseline D-dimer Concentration||predose and 1-8 hours||||mg/L||Standard Deviation|Mean
2619995|NCT01958645|Secondary|Change From Baseline Factor II Concentrations by Clot Assay||Predose and 1-8 hours||||% (concentration)||Standard Deviation|Mean
2619996|NCT01958645|Secondary|Change From Baseline Factor II Concentrations by ECL Assay||Predose and 1-8 hours||||umol/L||Standard Deviation|Mean
2619997|NCT01958645|Secondary|Change From Baseline Endogenous Thrombin Potential (ETP)|For the baseline variables and adverse events the two placebo arms (placebo dose 1 and placebo dose 2) are recorded as one. For the secondary outcome measures the two placebo arms are recorded separately.|Predose and Days 1-5||||nM*min||Standard Deviation|Mean
2619998|NCT01958645|Primary|Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination||From screening and up to the lab follow-up visit (Day 29)||||Participants|||Number
2619999|NCT01958619|Secondary|Piperaquine AUC0-∞|Piperaquine Area under plasma concentration time curve from time zero extrapolated to infinity.|Days 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours (Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5) and 168 (Day 8) hours post-dose. Sampling will also be done on Day 11, 15, 29 and 43.||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2620000|NCT01958619|Secondary|Piperaquine Cmax|Piperaquine Observed maximum drug plasma concentration|Days 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours (Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5) and 168 (Day 8) hours post-dose. Sampling will also be done on Day 11, 15, 29 and 43.||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2620001|NCT01958619|Primary|OZ439 AUC0-∞|OZ439 Area under plasma concentration time curve from time zero extrapolated to infinity.|Days 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours (Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5) and 168 (Day 8) hours post-dose. Sampling will also be done on Day 11, 15, 29 and 43.||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2620002|NCT01958619|Primary|OZ439 Cmax|OZ439 observed maximum drug plasma concentration|Days 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours (Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5) and 168 (Day 8) hours post-dose. Sampling will also be done on Day 11, 15, 29 and 43.||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2620003|NCT01958606|Other Pre-specified|Change in Stroke Impact Scale|Cognition Domain Score of Stroke Impact Scale. Scores range from 0 to 100 (higher is better) and represent a sum of scores from multiple questions related to cognition.|Baseline and 4 weeks||||units on a scale from 0-100||Standard Deviation|Mean
2620004|NCT01958606|Other Pre-specified|Change in Daily Physical Activity (Activity Monitor)||Baseline and 4 weeks|measure not used||||||
2620015|NCT01958606|Secondary|Change in Gait Economy (Mean Oxygen Uptake at Comfortable Walking Speed)|mean oxygen uptake at comfortable walking speed reported in units mLO2 per kilogram body weight per meter|Baseline and 4 weeks|Subjects with available data|||mLO2/kg/m||95% Confidence Interval|Mean
2620016|NCT01958606|Secondary|Change in 6-Minute Walk Test|distance walked in 6 minutes|Baseline and 4 weeks||||meters||95% Confidence Interval|Mean
2620017|NCT01958606|Secondary|Change in Gait Velocity (10 Meter Walk Test)||Baseline and 4 weeks||||m/s||95% Confidence Interval|Least Squares Mean
2620018|NCT01958606|Secondary|Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold)||Baseline and 4 weeks|ventilatory threshold was not identifiable for one participant|||ml/kg/min||95% Confidence Interval|Least Squares Mean
2620019|NCT01958606|Primary|Change in Peak Aerobic Capacity (VO2-peak)||Baseline and 4 weeks|on treatment analysis|||ml/kg/min||95% Confidence Interval|Least Squares Mean
2620020|NCT01958489|Primary|PK: Time of Maximum Observed Concentration (Tmax) of Pravastatin||Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose|All enrolled participants with evaluable tmax results at the specific time points.|||hours||Full Range|Median
2620021|NCT01958489|Primary|PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pravastatin||Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose|All participants who had evaluable AUC(0-∞) at the specific time points.|||nanograms*hours/milliliters (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2620022|NCT01958489|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Pravastatin||Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose|All participants who had evaluable Cmax results at the specific time points.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2620023|NCT01958476|Post-Hoc|Number of Infants Needing a Dose Increase|"One Finnegan score ≥12, or two consecutive scores ≥8 affirms the requirement for pharmacological treatment or increasing treatment dosage. If the infant continued to have two consecutive Finnegan Scores ≥8 two times consecutively, or one ≥12, the dose was increased to the next level. (Level I: 0.3 mg/kg/day) (Level II: 0.5 mg/kg/day) (Level III: 0.7 mg/kg/day)~A higher Finnegan score indicates greater severity of NAS (min 0, max 50)."|Participants were monitored for the duration of their hospitalization, an average of 22 days.||||Participants|||Count of Participants
2620024|NCT01958476|Other Pre-specified|Cognitive, Language, and Motor Development From 18 Month Bayley III Neurodevelopmental Assessment|The Bayley Scales of Infant and Toddler Development (BSID-III) assesses the development of infants and children (1-42 months) through a series of developmental play tasks, identifying children with developmental delay. Raw scores of completed items are summarized within three distinct scale scores (Cognitive Scale, Language Scale, Motor Scale). Scale scores are each converted to composite scores to determine the child's performance compared with scores of age-matched children of typical development (percentile rank). A higher composite score indicates more ideal developmental outcome (range 40-160). At 18 month follow-up visit, participants were assessed using the BSID-III for cognitive, language and motor scale composite score outcomes.|Assessment at 18 month follow-up visit|Includes subjects who were randomized and remained enrolled at 18 month follow-up visit.|||scores on a scale (Composite)||Standard Deviation|Mean
2620025|NCT01958476|Secondary|Growth Outcome: Length at 18 Months|Average length (cm) at 18 month follow-up visit.|18 month follow-up visit|Participants who were continuously enrolled and attended the 18 month follow-up visit for developmental and growth measures.|||cm||Standard Deviation|Mean
2620026|NCT01958476|Secondary|Maximum Finnegan Score|Maximum Finnegan score during the hospitalization|Participants monitored for the duration of their hospitalization.|Data were not collected due to insufficient funding to carry out data collection.||||||
2620027|NCT01958476|Secondary|Growth Outcome: Head Circumference at 18 Months|Average head circumference growth outcome at 18 month follow-up visit.|18 month follow-up visit|Participants who were continuously enrolled and attended the 18 month follow-up visit for developmental and growth measures.|||cm||Standard Deviation|Mean
2620028|NCT01958476|Secondary|Growth Outcome: Weight Change From Birth to 18 Months|Growth outcome weight (lbs) depicted as difference in averaged weights from birth to 18 month follow-up visit. Standard deviations were averaged between birth and 18 mo time points.|Birth to 18 month follow-up visit|Participants who were continuously enrolled and attended the 18 month follow-up visit for developmental and growth measures.|||lbs||Standard Deviation|Mean
2620029|NCT01958476|Secondary|Number of Infants Needing a Second NAS Medication|Number of infants treated with a second medication following protocol, phenobarbital. If the Finnegan Score remained elevated (still scored ≥8 two times consecutively, or still scored once ≥12) despite increasing to a predetermined maximal opioid dose (methadone or morphine), phenobarbital was administered (20-mg/kg loading dose followed by 4-5 mg/kg daily).|Participants were monitored for the duration of their hospitalization, an average of 22 days.|Includes infants requiring treatment for NAS who were randomized to either methadone or morphine study intervention. Analysis does not include Standard Clinical Care cohort.|||Participants|||Count of Participants
2620030|NCT01958476|Secondary|Mean Finnegan Score (FS)|Mean Finnegan withdrawal score during the duration of hospitalization.|Participants were monitored during their entire hospitalization|Data were not collected due to insufficient funding to carry out data collection.||||||
2620031|NCT01958476|Secondary|Maximum Daily Dose of Replacement Opioid|Maximum daily dose of neonatal morphine solution or methadone during the hospitalization|Participants were monitored for the duration of their hospitalization.|Data were not collected due to insufficient funding to carry out data collection.||||||
2620032|NCT01958476|Secondary|Length of Treatment (LOT)|Total number of days infant treated with replacement opioids while admitted to the hospital.|Participants were monitored for the duration of their hospitalization.|Includes infants requiring treatment for NAS who were randomized to either methadone or morphine study intervention. Analysis does not include Standard Clinical Care cohort.|||days||Standard Deviation|Mean
2620033|NCT01958476|Secondary|Length of Hospital Stay (LOS) Due to Neonatal Abstinence Syndrome (NAS)|Participants were monitored for the duration of their hospitalization attributable to NAS only.|Participants were monitored for the duration of their hospitalization, expected mean 22 days.|Includes infants requiring treatment for NAS who were randomized to either methadone or morphine study intervention. Analysis does not include Standard Clinical Care cohort.|||days||Standard Deviation|Mean
2620034|NCT01958476|Primary|Length of Hospital Stay (LOS)|Participants were monitored for the duration of their hospitalization, an expected mean of 22 days.|Participants will be monitored during their entire hospitalization, expected mean 22 days.|Includes infants requiring treatment for NAS who were randomized to either methadone or morphine study intervention. Analysis does not include Standard Clinical Care cohort.|||days||Standard Deviation|Mean
2620035|NCT01958437|Primary|Egocentric|Number of turns correctly recalled for each egocentric environment|Outcome assessed after each of the 2 sessions|Participants from each group were excluded due to movement artifact that invalidated fMRI data.|||Correct turns||Standard Deviation|Mean
2620036|NCT01958437|Primary|Dorsal Attention Network Connectivity During Resting-state fMRI|Change in resting state functional connectivity strength between active and sham tDCS sessions. Strength is measured by Pearson r correlations between nodes, which are z-transformed, and summated.|change between active and sham tDCS sessions (<1month)|Participants from each group were excluded due to movement artifact that invalidated fMRI data.|||arbitrary units||Standard Deviation|Mean
2620037|NCT01958437|Primary|Hippocampal BOLD Signal During Task-based fMRI|BOLD signal change comparing active to sham tDCS during Allocentric navigation (i.e., active HD-tDCS > sham HD-tDCS). Activation maps thresholded at p<.01 with minimum cluster size of 5 voxels.|change between active and sham tDCS sessions (<1month)|Participants from each group were excluded due to movement artifact that invalidated fMRI data.|||Percent signal change||Standard Deviation|Mean
2620038|NCT01958437|Primary|Accuracy in Centimeters From Target Location for Allocentric|"1 active tDCS; 1 sham tDCS for each measure. Participants touched a screen (using a ELO 19 touchscreen monitor) to document the location of the landmark. The distance between the actual vs. selected location served as the dependent measure."|Outcome assessed after each of 2 sessions (estimated within 1 week of each other)|Computer errors caused missing data for a subset (n=4) of participants; those data have simply been omitted from analyses below.|||Centimeters (cm)||Standard Deviation|Mean
2620039|NCT01958346|Secondary|Sore Throat Grade on First Postoperative Day|Patients will be asked to rate their sore throat qualitatively as none, mild, moderate, or severe|Postoperative day one||||participants|||Number
2620040|NCT01958346|Primary|Number of Participants With Successful Intubations on First Attempt; Grade(s) Were Not Measured.||At Intubation||||participants|||Number
2620041|NCT01958320|Other Pre-specified|Incidence of Pulmonary Hemorrhage|incidence of pulmonary hemorrhage|through hospital discharge (approximately 6 months unless death occurs first)||||Participants|||Count of Participants
2620042|NCT01958320|Other Pre-specified|Incidence of Bacteremia|incidence of bacteremia|through hospital discharge (approximately 6 months unless death occurs first)||||Participants|||Count of Participants
2620043|NCT01958320|Other Pre-specified|Number of Infants Who Received Dopamine for ≥3 Days|number of infants who received dopamine for ≥3 days|through hospital discharge (approximately 6 months unless death occurs first)||||Participants|||Count of Participants
2620044|NCT01958320|Secondary|Number of Infants Receiving ≥ 14 Days of Diuretic Treatment|number of infants receiving ≥ 14 days of diuretic treatment|through hospital discharge (approximately 6 months unless death occurs first)||||Participants|||Count of Participants
2620045|NCT01958320|Secondary|the Incidence of Rescue Treatment Eligibility Criteria Met|"Infants were eligible for rescue PDA drug treatment if they met one or more of the following prespecified Rescue criteria: 1) Inotrope-dependent hypotension for at least 3 days. 2) Oliguria that persisted for at least 2 days with no obvious cause, other than the moderate PDA, to explain the condition. 3) Requirement for gavage feedings beyond 35 weeks corrected age due to increased work of breathing. 4) Respiratory support needed after the following postnatal ages that surpassed specific minimal ventilation and FiO2 requirements: >15 days (if still required intubation and FiO2 >0.30), >20 days (if still required intubation and FiO2 ≤0.30; or still required Nasal CPAP or Nasal ventilation and FiO2 >0.30), >30 days (if still required Nasal CPAP or Nasal ventilation and FiO2 0.25-0.30), and >45 days (if still required Nasal CPAP or Nasal ventilation and FiO2 <0.25)."|through hospital discharge (approximately 6 months unless death occurs first)||||Participants|||Count of Participants
2620046|NCT01958320|Secondary|the Incidence of Persistent Moderate-to-large PDA Shunt 10 Days After Enrollment|"the incidence of persistent moderate-to-large PDA shunt 10 days after enrollment The echocardiographic studies included two dimensional imaging, M-mode, color flow mapping and Doppler interrogation as previously described. A moderate-to-large PDA was defined by a ductus internal diameter ≥ 1.5mm (or PDA:left pulmonary artery diameter ratio ≥0.5) and one or more of the following echocardiographic criteria: a) left atrium-to-aortic root (LA/Ao) ratio ≥1.6, b) ductus flow velocity ≤2.5m/sec or mean pressure gradient across the ductus ≤8mm, c) left pulmonary artery diastolic flow velocity > 0.2 m/sec, and/or d) reversed diastolic flow in the descending aorta. Ductus that failed to meet these criteria were considered to be constricted (small or closed) and not eligible for enrollment or treatment."|10 days after enrollment||||Participants|||Count of Participants
2620047|NCT01958320|Secondary|Incidence of Death|incidence of death|through hospital discharge (approximately 6 months unless death occurs first)||||Participants|||Count of Participants
2620048|NCT01958320|Secondary|Incidence of Bronchopulmonary Dysplasia or Death|incidence of bronchopulmonary dysplasia or death|determined between 36-37 weeks corrected age||||Participants|||Count of Participants
2620049|NCT01958320|Secondary|the Average Daily Weight Gain|the average daily weight gain|up to 20 weeks of age||||gm/kg/day||Standard Deviation|Mean
2620050|NCT01958320|Secondary|Incidence of Necrotizing Enterocolitis or Spontaneous Perforation|incidence of necrotizing enterocolitis or spontaneous perforation|through hospital discharge (approximately 6 months unless death occurs first)||||Participants|||Count of Participants
2620051|NCT01958320|Secondary|Duration of Gavage Feeding Assistance|duration of gavage feeding assistance|up to 20 weeks of age||||days||Inter-Quartile Range|Median
2620052|NCT01958320|Primary|Number of Infants Who Undergo in Hospital PDA Ligations or Who Have an Open Ductus at the Time of Discharge (That Need Future Outpatient Cardiology Follow-up Visits)|Number of infants who undergo in hospital PDA ligations or who have an open ductus at the time of discharge (that need future outpatient cardiology follow-up visits)|through hospital discharge (approximately 6 months unless death occurs first)||||Participants|||Count of Participants
2624505|NCT01923480|Secondary|Plasma Concentration of Leucine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
2620053|NCT01958294|Secondary|Procedural Success|Procedure Success - Procedural success is the ability to deliver therapeutic devices (balloons, stents, etc.) through the Transcervical Arterial Sheath and the ability to provide embolic protection throughout the procedure with the freedom of device related Major Adverse Events at 30 days.|Through 30-day Follow-up period|Successful delivery of therapeutic devices (balloons, stents, etc.) through the Transcervical Arterial Sheath and ability to provide embolic protection throughout the procedure with freedom from device related Major Adverse Events at 30 days|||participants|||Number
2620054|NCT01958294|Secondary|Acute Device Success|Acute device success - Defined as MICHI™ NPS was delivered (vascular access achieved), reverse flow was attempted and established and the device retrieved / removed from vasculature.|Intra procedural (1 day)|Subjects meeting the description of the outcome measures in which vascular access was achieved, reverse flow was successfully established, and the device retrieved from the vasculature.|||participants|||Number
2620055|NCT01958294|Primary|Composite of Any Stroke, Myocardial Infarction and Death|Composite Major Adverse Event (MAE) Rate of any stroke, myocardial infarction and death during the 30-day post procedural period.|30-days post-procedurally|Composite Major Adverse Event (MAE) Rate of any stroke, myocardial infarction and death during the 30-day post procedural period.|||participants|||Number
2620056|NCT01958281|Secondary|PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)|t1/2 is defined as the estimate of the terminal elimination half-life of the drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4|Participants in the PK Analysis Set from Cohort 3 with available data were analyzed.|||hours||Inter-Quartile Range|Median
2620057|NCT01958281|Secondary|PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)|t1/2 is defined as the estimate of the terminal elimination half-life of the drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||hours||Inter-Quartile Range|Median
2620058|NCT01958281|Secondary|PK Parameter: t1/2 of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)|t1/2 is defined as the estimate of the terminal elimination half-life of the drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||hours||Inter-Quartile Range|Median
2620059|NCT01958281|Secondary|PK Parameter: λz of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)|λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4|Participants in the PK Analysis Set from Cohort 3 with available data were analyzed.|||1/hour||Standard Deviation|Mean
2620060|NCT01958281|Secondary|PK Parameter: λz of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)|λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||1/hour||Standard Deviation|Mean
2620061|NCT01958281|Secondary|PK Parameter: λz of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)|λz is defined as the terminal elimination rate constant, estimated by linear regression of the terminal elimination phase of the log plasma concentration of drug versus time curve of the drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2|Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed.|||1/hour||Standard Deviation|Mean
2620062|NCT01958281|Secondary|PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)|Tlast is defined as the time (observed time point) of Clast.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4|Participants in the PK Analysis Set from Cohort 3 with available data were analyzed.|||hours||Inter-Quartile Range|Median
2620063|NCT01958281|Secondary|PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)|Tlast is defined as the time (observed time point) of Clast.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||hours||Inter-Quartile Range|Median
2620064|NCT01958281|Secondary|PK Parameter: Tlast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)|Tlast is defined as the time (observed time point) of Clast.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2|Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed.|||hours||Inter-Quartile Range|Median
2620065|NCT01958281|Secondary|PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)|Tmax is defined as the time (observed time point) of Cmax.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4|Participants in the PK Analysis Set from Cohort 3 with available data were analyzed.|||hours||Inter-Quartile Range|Median
2620066|NCT01958281|Secondary|PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)|Tmax is defined as the time (observed time point) of Cmax.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||hours||Inter-Quartile Range|Median
2620067|NCT01958281|Secondary|PK Parameter: Tmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)|Tmax is defined as the time (observed time point) of Cmax.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2|Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed.|||hours||Inter-Quartile Range|Median
2620068|NCT01958281|Secondary|PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)|Clast is defined as the last observable concentration of drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4|Participants in the PK Analysis Set from Cohort 3 with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2620069|NCT01958281|Secondary|PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)|Clast is defined as the last observable concentration of drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2620070|NCT01958281|Secondary|PK Parameter: Clast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)|Clast is defined as the last observable concentration of drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2|Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed.|||ng/mL||Standard Deviation|Mean
2620071|NCT01958281|Secondary|PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)|AUClast is defined as the concentration of drug from time zero to the last observable concentration.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4|Participants in the PK Analysis Set from Cohort 3 with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
2620072|NCT01958281|Secondary|PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)|AUClast is defined as the concentration of drug from time zero to the last observable concentration.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
2620073|NCT01958281|Secondary|PK Parameter: AUClast of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)|AUClast is defined as the concentration of drug from time zero to the last observable concentration.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2|Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed.|||h*ng/mL||Standard Deviation|Mean
2620074|NCT01958281|Secondary|Percentage of Participants With Overall Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2620075|NCT01958281|Secondary|Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)|SVR4 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2620076|NCT01958281|Secondary|Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2620077|NCT01958281|Primary|PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)|Ctau is defined as the observed drug concentration at the end of the dosing interval.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4|Participants in the PK Analysis Set from Cohort 3 with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2620078|NCT01958281|Primary|PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)|Ctau is defined as the observed drug concentration at the end of the dosing interval.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2620079|NCT01958281|Primary|PK Parameter: Ctau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)|Ctau is defined as the observed drug concentration at the end of the dosing interval.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2|Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed.|||ng/mL||Standard Deviation|Mean
2620080|NCT01958281|Primary|PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)|Cmax is defined as the maximum concentration of drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4|Participants in the PK Analysis Set from Cohort 3 with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2620081|NCT01958281|Primary|PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)|Cmax is defined as the maximum concentration of drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2620082|NCT01958281|Primary|PK Parameter: Cmax of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)|Cmax is defined as the maximum concentration of drug.|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2|Participants in the PK Analysis Set from Cohorts 1 and 2 were analyzed.|||ng/mL||Standard Deviation|Mean
2620083|NCT01958281|Primary|PK Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and LDV at Week 2 or 4 (Cohort 3)|AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2 or 4|Participants in the PK Analysis Set from Cohort 3 with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
2620084|NCT01958281|Primary|PK Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 12 (Cohorts 1 and 2)|AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 12|Participants in the PK Analysis Set from Cohorts 1 and 2 with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
2620085|NCT01958281|Primary|Pharmacokinetic (PK) Parameter: AUCtau of SOF, Its Metabolites (GS-566500 and GS-331007), and RBV at Week 2 (Cohorts 1 and 2)|AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).|Predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose at Week 2|Participants in the PK Analysis Set (all enrolled participants who took at least 1 dose of study drug and have at least 1 nonmissing postdose PK concentration value) from Cohorts 1 and 2 with available data were analyzed.|||h*ng/mL||Standard Deviation|Mean
2620086|NCT01958281|Primary|Percentage of Participants Experiencing Treatment-Emergent Adverse Events Associated With Vital Sign Abnormalities||Up to 24 weeks plus 30 days|Safety Analysis Set|||percentage of participants|||Number
2620087|NCT01958281|Primary|Percentage of Participants Experiencing Clinically Significant 12-lead Electrocardiogram (ECG) Abnormalities||Up to 24 weeks plus 30 days|Safety Analysis Set|||percentage of participants|||Number
2620088|NCT01958281|Primary|Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities|Treatment-emergent laboratory abnormalities were defined as values that increased by at least 1 toxicity grade from baseline at any time postbaseline up to the date of last dose of study drug plus 30 days.|Up to 24 weeks plus 30 days|Safety Analysis Set|||percentage of participants|||Number
2620089|NCT01958281|Primary|Percentage of Participants Experiencing Treatment-Emergent Adverse Events||Up to 24 weeks plus 30 days|Safety Analysis Set|||percentage of participants|||Number
2620090|NCT01958281|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled and took at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2620091|NCT01958164|Secondary|Percentage of Participants Who Achieved Restored CVAD Function After 1 Dose and 2 Doses, in Patients From the Actilyse Treatment Group.|This endpoint was defined as the number of doses required to achieve restored CVAD function in patients from the actilyse treatment group but was analysed as the percentage of participants who achieved restored CVAD function after 1 dose and 2 doses, in patients from the actilyse treatment group.|0 minutes and 240 minutes|All patients in the FAS who were randomised to the Actilyse treatment group|||percentage of participants|||Number
2620092|NCT01958164|Secondary|Restored CVAD Function 120 Minutes After Administration of the Second Dose of Study Medication Actilyse|Percentage of patients with restored CVAD function 120 minutes after administration of the second dose of study medication Actilyse (240 minutes after time 0)|240 minutes after first drug administration|All patients in the FAS who did not have restored CVAD function 120 minutes after first drug administration|||percentage of participants||95% Confidence Interval|Number
2620093|NCT01958164|Secondary|Restored CVAD Function 30 Minutes After Administration of the Second Dose of Study Medication Actilyse|Percentage of patients with restored CVAD function 30 minutes after administration of the second dose of study medication Actilyse (150 minutes after time 0)|150 minutes after first drug administration|All patients in the FAS who did not have restored CVAD function 120 minutes after first drug administration|||percentage of participants||95% Confidence Interval|Number
2620094|NCT01958164|Secondary|Restored CVAD Function 30 Minutes After Administration of Study Medication at Time 0|Percentage of patients with restored CVAD function 30 minutes after administration of study medication at time 0 (i.e. Actilyse® or saline solution)|30 minutes after first drug administration|Full analysis set (FAS) which included all randomised patients who received at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2620095|NCT01958164|Primary|Proportion of Patients With Restored CVAD Function at 120 Min After Administration of the First Dose of Study Medication|Proportion (percentage) of patients with restored central venous access device (CVAD) function at 120 min after administration of the first dose of study medication (i.e. Actilyse® or saline solution).|120 minutes after first drug administration|Full analysis set (FAS) which included all randomised patients who received at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2620096|NCT01958125|Secondary|Comparison of the Headache Pain Free Attack Rates at 30 Minutes Following the Treatment|"The headache pain was collected at the beginning of the attack and 30 minutes post treatment in the patient diary.~The number of pain free (no pain) attacks are compared to all attacks treated"|2 weeks|ITT-Intention To Treat population|||Number of attacks|||Number
2620097|NCT01958125|Secondary|Patients Who Used Any Type of Rescue Medication|Following treatment at 15 minutes, patients recorded use of any rescue medication(s) in the diary'|2 weeks|ITT-Intention To Treat population|||participants|||Number
2620098|NCT01958125|Secondary|Mean Change of Questionnaire EQ-5D-3L (Euroqol- 5D-3L) From Baseline to After 2 Weeks Treatment|"EQ-5D-3L descriptive system comprises 5 dimensions: mobility, self-care, activity, pain and anxiety. Each dimension has 3 levels: 1 = no problems, 2 = moderate problems, 3=extreme problems. Subjects indicate health state by ticking choosing appropriate statement in each dimension and a VAS scale (Overall health) from 0-100 mm where higher score is better (100) than lower score (0).~Patients completed the EQ-5D-3L at baseline (the start of the randomized period and at 2 weeks)."|2 weeks|Safety population, three patients in the Sham group had no data for EQ-5D-3L|||units on a scale||Standard Error|Mean
2620099|NCT01958125|Secondary|Change in Disability From Baseline (Randomization) to 2 Weeks After Baseline|"Mean difference of scores on a 5 step disability scale. Disability was measured at baseline and after the randomization phase (2 weeks later). Lowest score is 1 and is better than the higher score at 5 that is the worst. An increase, higher scores, means worsening.~minor~minor/moderate~moderate~moderate/severe~severe"|2 weeks|Safety population, three patients in the Sham device group have no data|||units on a scale||Standard Error|Mean
2620100|NCT01958125|Primary|Comparison of the Headache Pain Free Attack Rates at 15 Minutes Following the Treatment|"Headache pain was collected at the beginning of the attack (all treated attacks) and 15 minutes post treatment pain free attacks.~Data was collected in the patient diary."|2 weeks|ITT-Intention To Treat population|||Number of attacks|||Number
2620101|NCT01958112|Secondary|Overall Survival|Overall survival will be determined for subjects on this study|2 years||||months||95% Confidence Interval|Median
2620102|NCT01958112|Secondary|Mutation and Co-mutation Rates of Genes in the PI3K and RAS ERK Signaling Pathways in Recurrent Cervical Cancer Using High Throughput Targeted Mutational Analysis on Participant Tumor Samples.|The mutation and co-mutation rates of genes in the PI3K and RAS ERK signaling pathways in recurrent cervical cancer will be interrogated using high throughput targeted mutational analysis on participant tumor samples.|2 Years|Observed mutations and amplifications in genes related to PI3K or RAS signaling in the 13 patients with tissue available for testing. One patient did not have archival tissue available for testing, five patients did not have detected alterations.|||Participants|||Count of Participants
2620103|NCT01958112|Secondary|Toxicity of GSK1120212 (Trametinib) and GSK2141795 as Measured by the Number of Participants With Adverse Events|Toxicity was assessed for this combination by version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) in this cohort of patients. Toxicities reported were deemed related to study treatment.|2 Years||||Participants|||Count of Participants
2620104|NCT01958112|Secondary|Duration of Progression-free (PFS)|The duration of progression-free (PFS) following initiation of therapy with GSK1120212 (trametinib) and GSK2141795 will be measured.|2 Years|PFS events were determined by RECIST 1.1, clinical progression and death.|||months||95% Confidence Interval|Median
2620105|NCT01958112|Primary|Response Rate for the Combination of GSK1120212 (Trametinib) and GSK2141795 in Patients With Recurrent or Persistent Cervical Cancer.|Response rate will be assessed by RECIST version 1.1.|2 Years|Response rate assessed by RECIST version 1.1.|||Participants|||Count of Participants
2620106|NCT01958060|Secondary|AUC0-tz|Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose (AUC0-tz ).|2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.|Pharmacokinetic set (PKS)|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2620107|NCT01958060|Secondary|AUC0-inf|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).~AUC0-inf could be assessed only in 50 mg iv dose group as terminal phase was below lower limit of quantification (BLQ) for other dose groups. Therefore dose proportionality for AUC0-inf could not be performed in this trial."|2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.|Pharmacokinetic set (PKS):|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2620108|NCT01958060|Secondary|Cmax|Maximum measured concentration of BI 1034020 in plasma (Cmax).|2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.|Pharmacokinetic Set (PKS): This subject set included all subjects in the treated set who provide at least 1 observation for at least 1 secondary Pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2620109|NCT01958060|Primary|Percentage of Subjects With Drug Related Adverse Events|Percentage of subjects with investigator defined drug-related adverse events|from the first drug administration to end of trial, up to 50 days|Treated Set (TS)|||percentage of participants|||Number
2620110|NCT01958021|Secondary|QTc Interval|Time between the start of the Q wave and the end of the T wave corrected for heart rate|Baseline, cycle 1 day 15, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1, cycle 5 day 1, cycle 6 day 1, cycle 7 day 1, cycle 8 day 1, cycle 9 day 1|||||||
2620111|NCT01958021|Secondary|Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (QOL) Scale Score of the EORTC QLQ-C30|The time to definitive 10% deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10% relative to baseline worsening of the corresponding scale score (without further improvement above the threshold) or death due to any cause.|Up to approximately 20 months|||||||
2620112|NCT01958021|Secondary|Safety and Tolerability of LEE011|Safety will be determined by type, frequency and severity of adverse events per CTCAE version 4.03 and type, frequency and severity of laboratory toxicities per CTCAE version 4.03.|Up to approximately 21 months|||||||
2620113|NCT01958021|Secondary|Time to Definitive Deterioration of ECOG Performance Status in One Category of the Score|Time to definitive deterioration of ECOG performance status in one category of score is defined as the time from the date of randomization to the date of event, which is defined as at least one score lower than the baseline.|Up to approximately 20.5 months|||||||
2620114|NCT01958021|Secondary|Clinical Benefit Rate (CBR)|Clinical Benefit Rate (CBR) is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting more than 24 weeks as defined in RECIST 1.1.|Up to approximately 20 months|||||||
2620115|NCT01958021|Secondary|Overall Survival (OS)|Time from date of randomization to the date of death from any cause.|Up to approximately 65 months|||||||
2620116|NCT01958021|Secondary|Overall Response Rate (ORR) as Per Investigator Assessment|Overall response rate (ORR) is defined as the proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|Up to approximately 20 months|The Full Analysis Set (FAS- population) consisted of all randomized patients.|||percentage of participants||95% Confidence Interval|Number
2620117|NCT01958021|Primary|Progression Free Survival (PFS) Per Investigator Assessment|PFS, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1|Up to approximately 20 months|The Full Analysis Set (FAS- population) consisted of all randomized patients.|||months||95% Confidence Interval|Median
2620118|NCT01958008|Secondary|R(A,AUC)|R(A,AUC) (accumulation ratio of the BI 113608 in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of AUC at steady state and after first dose)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS|||ratio||Geometric Coefficient of Variation|Geometric Mean
2620119|NCT01958008|Secondary|R(A,Cmax)|R(A,Cmax) (accumulation ratio of the BI 113608 in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of Cmax at steady state and after first dose)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS|||ratio||Geometric Coefficient of Variation|Geometric Mean
2620120|NCT01958008|Secondary|T1/2,ss|T1/2,ss (terminal half life of the BI 113608 in plasma at steady state)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS|||hours||Geometric Coefficient of Variation|Geometric Mean
2620121|NCT01958008|Secondary|Tmax,ss|Tmax,ss (time from last dosing to maximum concentration of the BI 113608 in plasma at steady state)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS|||hours||Full Range|Median
2620122|NCT01958008|Secondary|AUC Tau,ss|AUC tau,ss (area under the concentration-time curve of the BI 113608 in plasma at steady state over a uniform dosing interval tau)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|PKS|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2620123|NCT01958008|Secondary|Cmax,ss|Cmax,ss (maximum measured concentration of BI 113608 in plasma at steady state over a uniform dosing interval tau)|Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration|Pharmacokinetic set (PKS): The patient set for the evaluation of PK endpoints included all evaluable patients in the treated set which provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2620124|NCT01958008|Primary|Number (%) of Patients With Drug-related Adverse Events (AEs)|Number (%) of patients with drug-related adverse events (AEs)|AE's occuring upto end of treatment + 3 days follow up (Up to 31 days)|Treated set (TS)|||percentage of participants|||Number
2620125|NCT01957930|Other Pre-specified|Microvascular Endothelial Function|Microvascular function is measured with a single point iontophoresis after stimulation with topically applied acetylcholine (ACh) [endothelial-dependent], sodium nitroprusside (SNP) [endothelial-independent], and capsaicin [C-nociceptive dependent] vasculature response.|7 years|||||||
2620126|NCT01957930|Primary|Ischemic Foot Ulcer|The study outcome is the first hospitalization for ischemic foot ulcer, defined by the ICD-10 discharge code|Until hospitalization for ischemic foot ulcer or until 31 December 2011|Data for Healthy Controls was not collected for this Outcome Measure.|||participants|||Number
2620127|NCT01957865|Secondary|HIV RNA Suppression|HIV RNA suppression (<100 copies/ml) in each study arm|After month 9|Note: Missing data equals lack of suppression. The participant found to be HIV negative was not included in the analysis.|||number of participants|||Number
2620128|NCT01957865|Primary|Antiretroviral Therapy (ART) Adherence Levels|ART adherence in each study arms. Adherence is measured by the Wisepill real-time adherence monitor and calculated as the number of monitor opening signals received divided by the number of monitor opening signals expected, capped at 100%.|real time (for 9 months)|The participant found to be HIV negative was not included in the analysis.|||Percent adherence||Standard Deviation|Mean
2620129|NCT01957787|Other Pre-specified|Change From Baseline in Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure at Month 1 and Month 3|The SF-12 is a shortened version of the well-known SF-36. The SF-12 assesses 8 domains (physical functioning, role limitations due to physical health problems, bodily pain, social functioning, general mental health, role limitations due to emotional problems, vitality, general health perception). The shorter instrument provides a general measurement of quality of life. Assessments were made by examining the change in the baseline scores to those reported post-operatively. The scores range from 0 to 100. A higher value indicates a better quality of life of the participant.|Baseline, Month 1 and Month 3|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population) and evaluable SF-12 scores.|||units on a scale||Standard Deviation|Mean
2620130|NCT01957787|Other Pre-specified|Change From Baseline in Physical Function as Assessed by the Karnofsky Performance Status (KPS) Scale at Months 1, 3, 6, 12, 18, and 24|The KPS scale is a standard way of measuring the ability of cancer participants to perform ordinary tasks. KPS may be used to determine a participant's prognosis and to measure changes in a participant's ability to function. Assessments were made by examining the change in the baseline scores to those reported post-operatively. KPS scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities.|Baseline, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population) and evaluable KPS scores.|||units on a scale||Standard Deviation|Mean
2620131|NCT01957787|Other Pre-specified|Cryoablation Technical Success at Month 1|A technically successful treatment was defined by the presence of an ablation zone, ground glass opacity, or frank consolidation encompassing the targeted index tumor(s) at no later than the 1 month follow up visit after the cryoablation procedure. Technical success rates and 95% confidence intervals (CIs) were calculated using random effects logistic regression on a tumor level.|Up to Month 1|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population).|||percentage of tumors|Number of Tumors|95% Confidence Interval|Number
2620132|NCT01957787|Other Pre-specified|Time to Untreatable Metastatic Lung Disease Control With Focal Therapy (Free From Metastatic Lung Disease)|Time to untreatable metastatic lung disease control with focal therapy defined as the time in days from the first cryoablation procedure to the time when the metastatic lung disease cannot be treated by focal (for example, ablation, surgery, SBRT) intervention for control of metastatic lung disease. The percentage of participants free from metastatic disease that is untreatable with focal therapy at the intervals of time of Days 181 to 365 and Days 495 to 730 is presented.|Month 12 (Days 181-365) and Month 24 (Days 495-730)|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population) with available data at the respective time point.|||percentage of participants|||Number
2620141|NCT01957761|Primary|Clostridium Difficile Infections Strain Type Based on Restriction Endonuclease Analysis|Stool samples taken from patients with Clostridium Difficile Infections infection at the time of diagnosis will be assessed by restriction endonuclease analysis to determine strain type. In order to study the relationship between strain type and outcome of their infection (e.g, treatment failure, recurrence, complication of illness), patients will be followed throughout their illness and for 8 weeks after developing their infection.|On day 1 of diagnosis of Clostridium difficile infection||||cases of BI/NAP1/027|||Number
2620133|NCT01957787|Other Pre-specified|Time to Untreatable Metastatic Lung Disease Control With Cryoablation (Free From Metastatic Lung Disease)|Time to untreatable metastatic lung disease control with cryoablation is defined as the time in days from the first cryoablation procedure to the time when the metastatic lung disease cannot be treated with cryoablation. The percentage of participants free from metastatic disease that is untreatable with cryoablation at the intervals of time of Days 181 to 365 and Days 495 to 730 is presented.|Month 12 (Days 181-365) and Month 24 (Days 495-730)|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population) with available data at the respective time point.|||percentage of participants|||Number
2620134|NCT01957787|Other Pre-specified|Local Tumor Control With Additional Cryoablation Galil Medical Technology Treatment(s) of a Previously Treated Index Tumor|Local tumor control, defined as absence of local treatment failure 12 months following study cryoablation based on site-reported data, was achieved if 3-axis measurement (that is, greatest trans-axial diameter plus 2 perpendicular diameters) of a tumor at Month 12 was <20% larger than 3-axis measurement of the tumor at Month 1 following study cryoablation. Separate evaluation of local tumor control at Month 12 following cryoablation was completed per index tumor. Follow-up visits were re-started after additional treatment, per study protocol and continued through the Month 24 visit after the last study cryoablation. Month 1 data served as baseline for analysis; if Month 1 data was missing, Month 3 data were used. Tumors with a local failure at prior study visit and with repeat cryoablation procedures prior to Month 12 were counted as failures. Tumor measurement imaging performed using CT or 18 F-fluorodeoxyglucose positron emission tomography-CT with or without contrast.|Up to Month 12|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population) and underwent an additional Cryoablation Galil Medical Technology Treatment.|||percentage of tumors|Number of Tumors||Number
2620135|NCT01957787|Other Pre-specified|Time to Overall Cancer Progression|Time to overall cancer progression was defined as the time in days from the first cryoablation procedure to cancer progression (that is, any location of active cancer disease). Participants without cancer progression were censored at the date of their last visit or their date of death (due to any cause).|Up to Month 24|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population).|||days||95% Confidence Interval|Median
2620136|NCT01957787|Other Pre-specified|Time to Metastatic Lung Disease Progression Beyond the Index Tumor(s)|Time to metastatic lung disease progression beyond the index tumor was defined as the time in days from the first cryoablation procedure to metastatic disease beyond the index tumor site. Participants without metastatic lung disease progression were censored at the date of their last visit or their date of death (due to any cause).|Up to Month 24|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population).|||days||95% Confidence Interval|Median
2620137|NCT01957787|Other Pre-specified|Overall Participant Survival Post-cryoablation|Overall survival rate was defined as the time in days from the first cryoablation procedure to death. Participants who were alive were censored at the date of the last visit.|Up to Month 24|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population).|||percentage of participants|||Number
2620138|NCT01957787|Other Pre-specified|Local Tumor Control for Each Index Tumor at Month 18 and Month 24|Local tumor control defined as the absence of local treatment failure 18 and 24 months following study cryoablation based on site-reported data. Local control was achieved if the 3-axis measurement (that is, the greatest trans-axial diameter plus the 2 perpendicular diameters) of a tumor at Month 12 was less than 20% larger than the 3-axis measurement of the tumor at Month 1 following study cryoablation. A separate evaluation of local tumor control at Month 12 following cryoablation was completed per index tumor. Month 1 data served as the baseline for this analysis; if Month 1 data was missing, Month 3 data were used. Tumors with a local failure at the prior study visit and those with repeat cryoablation procedures prior to Month 12 were counted as failures. Imaging for assessment of tumor measurements was performed using CT or 18 F-fluorodeoxyglucose positron emission tomography-CT with or without contrast.|Month 1 (Month 3 if Month 1 Data was missing), Month 18 and Month 24|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population). Multiple imputation methods for missing data were applied.|||percentage of tumors|Number of Tumors|95% Confidence Interval|Number
2620139|NCT01957787|Secondary|Number of Participants With an Intra- or Post-operative Adverse Event, a Serious Adverse Event, or an Unanticipated Adverse Device Effect|The number of participants with the following categories of adverse events is presented: an intra-operative, a post-operative, a serious adverse event, or an unanticipated adverse device effect. The adverse events that are presented are related to the cryoablation procedure. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to 30 days post-cryoablation|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population).|||Participants|||Count of Participants
2620140|NCT01957787|Primary|Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 12|Local tumor control defined as the absence of local treatment failure 12 months following study cryoablation based on site-reported data. Local control was achieved if the 3-axis measurement (that is, the greatest trans-axial diameter plus the 2 perpendicular diameters) of a tumor at Month 12 was less than 20% larger than the 3-axis measurement of the tumor at Month 1 following study cryoablation. A separate evaluation of local tumor control at Month 12 following cryoablation was completed per index tumor. Month 1 data served as the baseline for this analysis; if Month 1 data was missing, Month 3 data were used. Tumors with a local failure at the prior study visit and those with repeat cryoablation procedures prior to Month 12 were counted as failures. Imaging for assessment of tumor measurements was performed using CT or 18 F-fluorodeoxyglucose positron emission tomography-CT with or without contrast.|Month 1 (Month 3 if Month 1 Data was missing) and Month 12|Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed and met all study entry criteria (mITT population). Multiple imputation methods for missing data were applied.|||percentage of tumors|Number of Tumors|95% Confidence Interval|Number
2620174|NCT01957579|Primary|Number of Participants With Adverse Events||From baseline to 30 days after the last dose of study drug|All patients who received at least 1 dose of MEDI-551.|||Participants|||Number
2620142|NCT01957709|Secondary|Changes in Immune Response|To examine changes in the immune response to MRCL and SS by examining changes in the immune infiltrates, antibody response and antigen specific T cell response before and after IFNg treatment.|Baseline to 2 weeks post biopsy||||percentage of T cells||Full Range|Median
2620143|NCT01957709|Secondary|MHC Class II Expression|To determine whether systemic administration of IFNg will increase class II MHC expression in SS and MRCL tumors.|Baseline to 2 weeks post biopsy.||||percentage of MHC Class II on tumor cell||Full Range|Median
2620144|NCT01957709|Primary|Change in Class I Major Histocompatibility Complex (MHC) Expression After Treatment With IFN Gamma|It would be highly relevant to observe marked increase macrophages (effect size > 2.5). Four patients gives over 90% power to detect such a large increase with a two-tailed alpha of 0.05.|Baseline to up to 2 weeks post-surgery||||percentage of MHC Class I+ on tumor cell||Full Range|Median
2620145|NCT01957657|Secondary|Cmax (Maximum Measured Concentration of Faldaprevir in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.||||||
2620146|NCT01957657|Secondary|Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.||||||
2620147|NCT01957657|Secondary|Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.||||||
2620148|NCT01957657|Secondary|Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.||||||
2620149|NCT01957657|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of Faldaprevir in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.||||||
2620150|NCT01957657|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168 Acylglucuronide) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.||||||
2620151|NCT01957657|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (BI 208333) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.||||||
2620177|NCT01957475|Primary|Degree of Leakage|"The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (best possible outcome) and 32 points represents full-plate leakage (worst possible outcome).~The degree of leakage was measured at each baseplate change."|14 days||||units on a scale|Participants|Standard Deviation|Mean
2620152|NCT01957657|Secondary|AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) Metabolite (CD 6168) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.||||||
2620153|NCT01957657|Secondary|Number (%) of Subjects With Drug-related Adverse Events|Number (percentage) of subjects with drug-related adverse events|From the first drug administration until last drug administration, up to 10 days|Treated set (TS) included all enrolled subjects, who had taken at least one dose of trial medication.|||percentage of participants|||Number
2620154|NCT01957657|Primary|Cmax (Maximum Measured Concentration of Deleobuvir (BI 207127) in Plasma)|Blood sampling for PK profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined||||||
2620155|NCT01957657|Primary|AUC 0-infinity (Area Under the Concentration-time Curve of Deleobuvir (BI 207127) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|Blood sampling for Pharmacokinetic (PK) profiles was performed after the last dosing of the combination treatment on Day 4 at the following time points: for deleobuvir (BI 207127) and metabolites at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 10, 12, 24, 48 and 72 h after dosing; for faldaprevir at 0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration in the morning.|Day 4|Boehringer Ingelheim decided to stop the further development of the interferon-free combination therapy for Hepatitis C and terminated the trial prematurely on 27 Dec 2013. Since the sample size achieved at trial termination was much smaller than the planned sample size the pharmacokinetic endpoints were not determined.||||||
2620156|NCT01957644|Secondary|Percentage of Patients With Objective Response (OR)|"OR was defined as best overall response of complete remission (CR) or partial remission (PR) defined according to the International Working Group (IWG) 2006 criteria.~Complete remission (CR):~Bone marrow: <5 % myeloblasts with normal maturation of all cell lines*~Persistent dysplasia will be noted*~Peripheral blood:~hemoglobin (Hgb) > 11 Grams Per Decilitre (g/dL)~Platelets >100 x 109/L~Neutrophils > 1.0 x 109/L~Blasts 0 % *Dysplastic changes should consider the normal range of dysplastic changes~Partial remission (PR):~All CR criteria if abnormal before treatment except:~Bone marrow blasts decreased by >50% to pre-treatment but still >5%~Cellularity and morphology not relevant"|From randomisation until data cut-off (16Dec2016); up to 159 weeks|Efficacy set (ES): All the treated patients without any protocol violations related to efficacy|||percentage of participants|||Number
2620157|NCT01957644|Primary|Number of Participants With Dose Limiting Toxicities (DLT) in Cycle 1|Number of participants with Dose Limiting Toxicities (DLT) in Cycle 1 (escalation part to determine MTD) is presented .|4 weeks|MTD set|||participants|||Number
2620158|NCT01957644|Primary|Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in Cycle 1|"The primary objective of the dose-escalation part of this study was to determine the MTD of volasertib in combination with azacitidine. The MTD was to be identified based on the DLT information collected during the first treatment cycle of each dosing schedule. DLT was defined as a non-haematological drug-related toxicity of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3. The MTD corresponded to the highest dose of volasertib and azacitidine at which the incidence of DLT was ≤17% (i.e. 1/6 patients) during Cycle 1.~The planned dose escalation schedules of Part 2 were not completed because the trial was prematurely discontinued. Hence, a final conclusion of the MTD of volasertib in combination with azacitidine cannot be drawn in this trial.~Number of patients with DLT in cycle 1 in escalation part is presented to determine MTD."|4 weeks|MTD set: The MTD set was used for the first treatment cycle (Cycle 1) analysis and excluded any treated patients that missed any dose of trial medication in Cycle 1 for reasons other than DLT|||Milligram (mg)|||Number
2620159|NCT01957579|Secondary|Number of Participants With Tumour Response in MM Patients|"Tumour response is defined as complete response (CR) or partial response (PR) (Durie M et al 2006).~CR: Negative immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas and 5% or less plasma cells in bone marrow PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200mg per 24 h. If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. If serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition to the above listed criteria, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required."|From the baseline to30 days after the last dose of study drug|All patients with MM who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.|||Participants|||Number
2620175|NCT01957553|Primary|Preference|The subjects were asked which product they preferred (the Test product or SenSura) at the end of the investigation. The preference result shows the percentage of subjects preferring either the Test product or SenSura.|21+1 days|The ITT population was constituted by all randomized subjects with valid informed consent who had applied at least one test product and had valid information for the primary endpoint preference, or valid information for at least one product with respect to one of the secondary endpoints., who included all subject who contributed with endpoint data|||percentage of participants|||Number
2620176|NCT01957488|Primary|Leakage|The fraction of baseplates with No leakage/seeping under the baseplate was measured. Leakage/seeping under the baseplate was assessed after each baseplate change.|14 +- 1 days||||percentage of baseplates|Participants||Number
2620160|NCT01957579|Secondary|Number of Participants With Tumour Response in CLL Patients|"Tumour response is defined as complete remission (CR) or partial remission (PR) (Hallek M et al 2008).~CR: all of the following criteria have to be met, and patients have to lack disease-related constitutional symptoms; Lymphadenopathy: None; Hepatomegaly: None; Splenomegaly: None; Blood lymphocytes: <4000/μL; Marrow: Normocellular, <30%lymphocytes, no B-lymphoid nodules, hypocellular marrow defines CR with incomplete marrow recovery; Platelet count: >100000/μL; Hemoglobin: >11.0 g/dL; Neutrophils: >1500/μL PR: at least 2 of the criteria of group A plus 1 of the criteria of group B have to be met.~Group A: Lymphadenopathy: Decrease ≥50%; Hepatomegaly: Decrease ≥50%; Splenomegaly: Decrease ≥50%; Blood lymphocytes: Decrease ≥50% from baseline; Marrow: 50% reduction in marrow infiltrate, or B-lymphoid nodules.~Group B: Platelet count: 100000/μL or increase ≥50% over baseline; Hemoglobin: >11.0 g/dL or increase ≥50% over baseline; Neutrophils: >1500/μL or >50% improvement over baseline."|From the baseline to 30 days after the last dose of study drug|All patients with CLL who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.|||Participants|||Number
2620161|NCT01957579|Secondary|Number of Participants With Tumour Response in DLBCL Patients|"Tumour response is defined as complete remission (CR) or partial remission (PR) (Cheson BD et al 2007).~CR: Nodal Masses: (a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative; (b) Variably FDG-avid or PET negative; regression to normal size on CT; Spleen, Liver: Not palpable, nodules disappeared. Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative.~PR: Nodal Masses: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes; (a) FDG-avid or PET positive prior to therapy; ≥1 PET positive at previously involved site; (b) Variably FDG-avid or PET negative; regression on CT. Spleen, Liver: ≥50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified."|From the baseline to 30 days after the last dose of study drug|All patients with DLBCL who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.|||Participants|||Number
2620162|NCT01957579|Secondary|Number of Participants With Tumour Response in FL Patients|"Tumour response is defined as complete remission (CR) or partial remission (PR) (Cheson BD et al 2007).~CR: Nodal Masses: (a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative; (b) Variably FDG-avid or PET negative; regression to normal size on CT; Spleen, Liver: Not palpable, nodules disappeared. Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative.~PR: Nodal Masses: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes; (a) FDG-avid or PET positive prior to therapy; ≥1 PET positive at previously involved site; (b) Variably FDG-avid or PET negative; regression on CT. Spleen, Liver: ≥50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified."|From the baseline to 30 days after the last dose of study drug|All patients with FL who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.|||Participants|||Number
2620163|NCT01957579|Secondary|Anti-MEDI-551 Antibodies|Only 1 patient was tested positive for ADA at pre-dose of Cycle 1 Day 1. However, it was considered as false-positive because the titer value was close to the cut point, and this patient was tested negative for ADA at all subsequent cycles post-baseline.|From baseline to 30 days after the last dose of study drug|Patients who have at least one post-baseline sample for Anti-MEDI-551 antibodies.|||Participants|||Number
2620164|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 168|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 168|Patients who have trough concentration data at Day 168|||μg/mL||Standard Deviation|Mean
2620165|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 140|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 140|Patients who have trough concentration data at Day 140|||μg/mL||Standard Deviation|Mean
2620166|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 112|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 112|Patients who have trough concentration data at Day 112|||μg/mL||Standard Deviation|Mean
2620167|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day84|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 84|Patients who have trough concentration data at Day 84|||μg/mL||Standard Deviation|Mean
2620168|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 56|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 56|Patients who have trough concentration data at Day 56|||μg/mL||Standard Deviation|Mean
2620169|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 28|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 28|Patients who have trough concentration data at Day 28|||μg/mL||Standard Deviation|Mean
2620170|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 7|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 7|Patients who have trough concentration data at Day 7|||μg/mL||Standard Deviation|Mean
2620171|NCT01957579|Secondary|MEDI-551 Trough Concentration Levels at Day 0 (Pre-dose)|Lower limit of quantification for MEDI-551 was 0.1 μg/mL.|Day 0 (pre-dose)|Patients who have trough concentration data at Day 0 (pre-dose)|||μg/mL||Standard Deviation|Mean
2620172|NCT01957579|Secondary|Maximum Tolerated Dose|A dose was considered non-tolerated and dose escalation stopped if ≥2 of up to 6 evaluable patients experienced a DLT at any dose level. MTD is the last dose level before the non-tolerated dose.|From baseline to 28 days after the first dose of study drug|All subjects in the dose escalation phase who have received MEDI-551 at Day 1 and Day 8 and completed the safety follow-up through the dose-limiting toxicity (DLT) evaluation period (28 days), or who experienced a DLT.|||mg/kg|||Number
2620173|NCT01957579|Secondary|Number of Participants With Dose Limiting Toxicities|A MEDI-551 treatment-related AE of any toxicity grade that lead to an inability to receive a full cycle (2 doses) of MEDI-551, or, any Grade 3 or higher toxicity that could not be reasonably ascribed to another cause, such as disease progression or accident.|From baseline to 28 days after the first dose of study drug|All subjects in the dose escalation phase who have received MEDI-551 at Day 1 and Day 8 and completed the safety follow-up through the dose-limiting toxicity (DLT) evaluation period (28 days), or who experienced a DLT.|||Participants|||Number
2620178|NCT01957462|Primary|Degree of Leakage|"The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (the best possible outcome) and 32 points represents full plate leakage (worst possible outcome).~The degree of leakage is measured at each baseplate change"|14 days||||units on a scale|Participants|Standard Deviation|Mean
2620179|NCT01957410|Primary|Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Motor Evoked Potential (MEPs) Amplitudes at 4 Hours Postdose on Day 1|MEPs are generated when stimulation of the brain on the motor cortex (with Transcranial Magnetic Stimulation [TMS]) causes the spinal cord and peripheral muscles to produce neuroelectrical signals. MEPs are typically measured in the hand muscles. The Motor Evoked Response to Transcranial Magnetic Stimulation (TMS MEPs) was evaluated at baseline and regularly after study drug administration. Intracortical inhibition and facilitation was also evaluated using TMS. A figure-of-eight coil with external loop diameters of 9 cm was used to elicit motor responses in the contralateral first dorsal interosseus.|Baseline and Day 1 (4 hours postdose)|Efficacy analysis set included all participants who received a dose of ketamine and who had at least 1 postbaseline value of MEP.|||mV||Standard Deviation|Mean
2620180|NCT01957410|Primary|Comparison of Ketamine Responders and Ketamine Non-responders in the Change From Baseline in Somatosensory Evoked Potential (SEPs) Amplitudes at 4 Hours Postdose on Day 1|SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli - typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs was recorded using a 64-channel EEG system at baseline (predose) and regularly after study drug administration. The change from baseline was calculated as post-baseline value minus baseline value for each participant. Since the number of participants at baseline differ from the number of participants at post-baseline measure (that is [i.e.] not all baseline values are paired), the mean change is not equal to the difference between the means at the two time points.|Baseline and Day 1 (4 hours postdose)|Efficacy analysis set included all participants who received a dose of ketamine and who had at least 1 postbaseline value of SEP (P40).|||millivolts (mV)||Standard Deviation|Mean
2620181|NCT01957397|Primary|Degree of Leakage|The degree of leakage was measured with a 32 -point scale developed by Coloplast A/S, where 0 is the best possible outcome (no leakage) and 32 is the worst possible outcome (full leakage under the baseplate)|14 days||||units on a scale|Participants|Standard Deviation|Mean
2620182|NCT01957384|Primary|Degree of Leakage|The degree of leakage was measured on a 24-point scale 0 (best possible outcome) to 24 (worst possible outcome) developed by Coloplast A/S|Up to 14 days per test product||||units on a scale|Participants|Standard Deviation|Mean
2620183|NCT01957215|Secondary|Total Dose of Rescue Medication Use|Rescue medication use was monitored throughout a period of 14 days.|Baseline (Day 1) to Day 14|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Dose||Full Range|Median
2620184|NCT01957215|Secondary|Time to First Dose of Rescue Medication Use|Rescue medication use was monitored throughout a period of 14 days.|Baseline (Day 1) to Day 14|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Days||95% Confidence Interval|Median
2620185|NCT01957215|Secondary|Rate of Rescue Medication Use|Rescue medication use was monitored throughout a period of 14 days.|Baseline (Day 1) to Day 14|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Number of participants|||Number
2620186|NCT01957215|Secondary|Patients' Global Assessment to Treatment|Patients global assessment in response to treatment was measured at the end of the study on a scale of 0 to 4 where: 0- Poor; 1- Fair; 2- Good; 3- Very Good; 4- Excellent|Baseline (Day 1) to Day 14|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Score on scale||Standard Error|Least Squares Mean
2620187|NCT01957215|Secondary|Total Pain Relief (TOTPAR) on Movement|"TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, baseline), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs. Higher score indicated greater pain relief.~TOTPARt = ∑PR x (time t - time t-1). PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief]."|Baseline (Day 1) to Day 7|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Score on scale||Standard Error|Mean
2620188|NCT01957215|Secondary|Sum of Pain Intensity Difference and Pain Relief (SPRID) on Movement|"SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point.~SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time; 0 hr (Day 1, pre treatment), 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr, 12 hr, 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr, respectively.~PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [based on NRS which is a horizontal line with a scale from 0-10. where 0 represents No and 10 represents the worst possible pain]. NR scores were converted into PID scores by subtracting them from baseline pain scores.~PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]"|Baseline (Day 1) to Day 7|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Score on scale||Standard Error|Least Squares Mean
2620228|NCT01956773|Secondary|Number of Participants Reporting Comfort When Using the MeTree Tool|The study will assess comfort associated with using the MeTree tool via 3 months survey after completing the family health history collection. The participant were asked if the MeTree program was easy to use|3 months|Patients who completed 3 months post survey and reported on their level of comfort|||Participants|||Count of Participants
2620742|NCT01952665|Secondary|Participant Likelihood of Recommendation of a Study Lens|Participant likelihood of recommending a study lens to friends. Collected at study exit. (1-4; 1=Very Unlikely, 2=Unlikely, 3=Likely, 4=Very Likely).|4 weeks||||participants|||Number
2620189|NCT01957215|Secondary|Assessment of Sum of Pain Intensity Difference (SPID) on Movement|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, pre treatment), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (time t - time t-1).~Pain Intensity was assessed at baseline and at each time-point based on numerical rating scale (NRS) which is a horizontal line with a scale from 0-10, where 0 represents No and 10 represents the worst possible pain."|Baseline (Day 1) to Day 7|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Score on scale||Standard Error|Least Squares Mean
2620190|NCT01957215|Secondary|Time to Onset of Pain Relief|"Time to onset of pain relief was measured by the time to reach a pain relief score of 1 (A little or perceptible pain relief)."|Baseline (Day 1) to Day 3|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Days||Full Range|Median
2620191|NCT01957215|Secondary|Change From Baseline in NRS at Rest|Mean changes in pain intensity at each time point at rest twice daily (in the morning and afternoon) from treatment day 1 to day 7 between treatment groups at time points 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs, 84 hrs, 96 hrs, 108 hrs, 120 hrs, 132 hrs and 144 hrs was measured using NRS. The NRS is a horizontal line with a scale from 0-10. After application of patch (indomethacin or reference patch), participants were asked to choose a number that relates to their pain intensity on the scale of 0 to 10, where 0 represents no pain and 10 represents the worst possible pain.|Baseline (Day 1) to Day 7|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Score on scale||Standard Error|Least Squares Mean
2620192|NCT01957215|Secondary|NRS for Pain on Movement Over Time|"NRS was assessed for pain on movement (walking 5 steps on flat surface) at 30, 60 minutes and 2, 4, 8 and 12 hrs after the first dose of treatment (indomethacin or placebo patch) and twice daily during the period from 12 hours to 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr between treatment groups.~The NRS is a horizontal line with a scale from 0-10. After application of patch (indomethacin or reference patch), patients were asked to choose a number that relates to their pain intensity on the scale of 0 to 10, where 0 represents no pain and 10 represents the worst possible pain."|30 mins to 144 hr post treatment|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Score on scale||Standard Deviation|Mean
2620193|NCT01957215|Secondary|Pain Relief Score (PRS) on Movement Over Time|"PRS was assessed for pain on movement (walking 5 steps on flat surface) at 30, 60 minutes and 2, 4, 8 and 12 hrs after the first dose of treatment (indomethacin or placebo patch) and twice daily during the period from 12 hours to 24 hr, 36 hr, 48 hr, 60 hr, 72 hr, 84 hr, 96 hr, 108 hr, 120 hr, 132 hr and 144 hr between treatment groups.~Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score."|30 minutes (mins) to 144 hours (hrs) post treatment|Efficacy analysis was conducted on ITT population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement.|||Score on scale||Standard Deviation|Mean
2620194|NCT01957215|Primary|Sum of Pain Intensity Difference (SPID)1-3 Days|"SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0 hrs (Day 1, pre treatment), 0.5 hrs, 1 hr, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs and 48 hrs. Positive and higher scores indicate greater reduction in pain. SPIDt = ∑PID x (time t - time t-1).~Pain Intensity was assessed at baseline and at each time-point based on numerical rating scale (NRS) which is a horizontal line with a scale from 0-10, where 0 represents No and 10 represents the worst possible pain"|Baseline (Day 1) to Day 3|Efficacy analysis was conducted on the Intent-to-Treat (ITT) population, defined as those participants who received study treatment and had at least one post-baseline efficacy measurement|||Score on scale||Standard Error|Least Squares Mean
2620195|NCT01957202|Secondary|Weighted Mean of the Total Ocular Symptom Score (TOSS) (0-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 8 of Each Treatment Period|The TOSS (score of 0-9) is defined as the sum of the symptom scores for the three individual components (red, itchy, and tearing eyes , each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe], average of two eyes). TOSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen was administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TOSS was calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each treatment period (up to 80 days)|PD Population. Only those participants contributing data at the indicated time points were analyzed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2620196|NCT01957202|Secondary|Weighted Mean of the Magnitude of Symptom Relief on Total Ocular Symptom Score (TOSS) (2-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 1 of Each Treatment Period|Magnitude of symptom relief was assessed by calculating change from pre-dose weighted mean TOSS (2-4h) post start of the allergen chamber challenge at Day 1. The pre-dose value was the maximum of the three pre-dose measurements (1h 15 minutes (min), 1h 30 min and 1h 45 min post start of the allergen chamber challenge). The TOSS (score of 0-9) is defined as the sum of the symptom scores for the three individual components (red, itchy, and tearing eyes, each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe], average of two eyes).|Day 1 of each treatment period (up to 80 days)|PD Population|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2620230|NCT01956773|Primary|Number of Participants With Uptake of Genetic Counseling for Those at Risk of Hereditary Conditions at 1 Year|How many patients identified as meeting criteria for genetic counseling, how many providers ordered genetic counseling, and how many patients adhere to the provider recommendation at 1 year.|Baseline, 3 and 12 months|Patients who completed intervention and meeting criteria for genetic counseling|||Participants|||Count of Participants
2620197|NCT01957202|Secondary|Weighted Mean of the Magnitude of Symptom Relief on Total Nasal Symptom Score (TNSS) (2-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 1 of Each Treatment Period|Magnitude of symptom relief was assessed by calculating change from pre-dose weighted mean TNSS (2-4h) post start of the allergen chamber challenge at Day 1. The pre-dose value was the maximum of the three pre-dose measurements (1h 15 minutes (min), 1h 30 min and 1h 45 min post start of the allergen chamber challenge). The TNSS (score of 0-12) is defined as the sum of the symptom scores for the four individual components (nasal congestion, rhinorrhea, nasal itch and sneezing, each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe]).|Day 1 of each treatment period (up to 80 days)|PD Population|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2620198|NCT01957202|Primary|Weighted Mean of the Total Nasal Symptom Score (TNSS) (0-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 8 of Each Treatment Period|The TNSS (score of 0-12) is defined as the sum of the symptom scores for the four individual components (nasal congestion, rhinorrhea, nasal itch, and sneezing, each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe]). TNSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen was administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each treatment period (up to 80 days)|Pharmacodynamic (PD) Population: all participants in the All Subjects Population (defined as all participants who received at least one dose of investigational product) and who also provided data from at least one PD assessment. Only those participants contributing data at the indicated time points were analyzed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2620199|NCT01957163|Secondary|Change From Baseline in Weighted Mean (WM), 0-6 Hour FEV1 Obtained Post-dose at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The 0-6 hour weighted mean was derived by calculating the area under the FEV1/time curve over the nominal time points of 0 hour (trough value), 15 and 30 min, 1, 3 and 6 hours, using the trapezoidal rule, and then dividing by the actual time between dosing and the 6 hour assessment. Analysis was performed using MMRM with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, Day, and Day by Baseline and Day by treatment interactions. Baseline FEV1 is the mean of the two assessments made at 30 and 5 min pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value.|Day 84|ITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the ITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
2620200|NCT01957163|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 84. Analysis was performed using a mixed model repeated measures (MMRM) with covariates of treatment, Baseline FEV1, smoking status, Day, treatment, Day by baseline interaction and Day by treatment interaction, Day being nominal. Baseline FEV1 is the mean of the two assessments made at 30 and 5 minutes (min) pre-dose on Day 1. The change from baseline value is the difference between the on-treatment value and the baseline value.|Day 85|ITT Population: all pars. randomized to treatment who received ≥ 1 dose of randomized study medication in the Treatment Period. Number of pars. presented represent those with data available at given time point; however, all pars. in the ITT population without missing covariate information, with ≥ 1 post BL measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
2620201|NCT01957150|Secondary|Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4)|"BMD analysis performed on log (BMD ratio to baseline) using a repeated measures model with covariates of treatment group, age, gender, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the While on Treatment estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100."|Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percentage Change||95% Confidence Interval|Least Squares Mean
2620202|NCT01957150|Secondary|Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4) by Gender (Female Participants)|"BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the While on Treatment estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100."|Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent change||95% Confidence Interval|Least Squares Mean
2620229|NCT01956773|Secondary|Number of Participants Reporting Satisfaction When Using the MeTree Tool|The study will assess satisfaction associated with using the MeTree tool via 3 months survey after completing the family health history collection. The participant were asked their level of satisfaction with their experience using the web-based portal to enter information for their provider before their appointment|3 months|Patients who completed 3 months post survey and reported their level of satisfaction|||Participants|||Count of Participants
2620203|NCT01957150|Secondary|Percentage Change From Baseline in BMD Measurements at Lumbar Spine (L1 to L4) by Gender (Male Participants)|"BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the While on Treatment estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100."|Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent change||95% Confidence Interval|Least Squares Mean
2620204|NCT01957150|Secondary|Percentage Change From Baseline in BMD Measurements at Total Hip by Gender (Female Participants)|"BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the While on Treatment estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100."|Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent change||95% Confidence Interval|Least Squares Mean
2620205|NCT01957150|Secondary|Percentage Change From Baseline in BMD Measurements at Total Hip by Gender (Male Participants)|"BMD analysis performed on log (BMD ratio to baseline) using separate repeated measures models for each gender with covariates of treatment group, age, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the While on Treatment estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100."|Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|||Percent change||95% Confidence Interval|Least Squares Mean
2620206|NCT01957150|Primary|Percentage Change From Baseline in Bone Mineral Density (BMD) Measured at Total Hip|"BMD analysis performed on log (BMD ratio to baseline) using a repeated measures model with covariates of treatment group, age, gender, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the While on Treatment estimand of the difference in percentage change from baseline per annum between FF/VI ± BMD medication/SCS (systemic corticosteroids) and VI ± BMD medication/SCS. Baseline is defined as the measurement performed at Visit 1. Percentage change is calculated as (BMD value post-Baseline divided by Baseline value) -1 multiplied by 100."|Baseline (Visit 1) and 26, 52, 78, 104, 130 and 156 Weeks|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).All randomized participants who received at least one dose of study treatment were included in Safety Population.|||Percentage change||95% Confidence Interval|Least Squares Mean
2620207|NCT01957137|Secondary|Adverse Events - no Stimulation|Summary of adverse device effects when subjects were under no stimulation is provided. Percentage of subjects experiencing any type of Adverse Device Effect under no stimulation is presented.|4 Weeks|28 subjects who received no stimulation were included in the analysis.|||Percent of Subjects|||Number
2620208|NCT01957137|Secondary|Global Response Assessment - no Stimulation|Summary of GRA under no stimulation setting is provided. The GRA assessed incontinence symptoms as compared to symptoms prior to subject's entry into the study. Subjects were asked how much their incontinence changed since starting the study: markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved. The responses to the symptom change were categorized into three levels for the analysis: worse (markedly worse, moderately worse, mildly worse), same (same), better (slightly improved, moderately improved, or markedly improved).|4 Weeks|28 subjects who received no stimulation were included in the analysis.|||Percent of Subjects|||Number
2620209|NCT01957137|Secondary|Number of Pads Used Per Day - no Stimulation|Number of pad use were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.|4 Weeks|28 subjects who received no stimulation were included in the analysis.|||Pad use / day||Standard Deviation|Mean
2620210|NCT01957137|Secondary|Degree of Urgency - no Stimulation|Each UUI episode was rated on following scales: 0=None, 1=Mild, 2=Moderate, 3=Severe, which were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. The average degree of urgency per UUI episode was calculated from the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.|4 weeks|28 subjects who received no stimulation were included in the analysis.|||units on a scale||Standard Deviation|Mean
2620211|NCT01957137|Secondary|Number of UUI Episodes Per Day - no Stimulation|UUI episodes were collected through a diary on daily basis for approximately 4 weeks when subjects were under no stimulation. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.|4 Weeks|28 subjects who received no stimulation were included in the analysis.|||Number of UUI episodes/ Day||Standard Deviation|Mean
2620212|NCT01957137|Secondary|Global Response Assessment (GRA) - Randomized Portion|"Summary statistics of GRA at different cycling settings are provided. The GRA assessed incontinence symptoms as compared to symptoms prior to subject's entry into the study. Subjects were asked how much their incontinence changed since starting the study: markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved. The responses to the symptom change were categorized into three levels for the analysis: worse (markedly worse, moderately worse, mildly worse), same (same), better (slightly improved, moderately improved, or markedly improved).~Percentages of subjects reported worse, same or better under each cycling setting since starting the study are presented."|4 weeks|24 subjects who first completed unique randomization sequences were included in the analysis.|||Percent of Subjects|||Number
2620213|NCT01957137|Secondary|Number of Pads Used Per Day - Randomized Portion|Number of pad use were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.|4 weeks|24 subjects who first completed unique randomization sequences were included in the analysis.|||Pads per day||95% Confidence Interval|Least Squares Mean
2620214|NCT01957137|Secondary|Degree of Urgency - Randomized Portion|Each UUI episode was rated on following scales: 0=None, 1=Mild, 2=Moderate, 3=Severe, which were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. The average degree of urgency per UUI episode was calculated from the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.|4 week|24 subjects who first completed unique randomization sequences were included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2620215|NCT01957137|Primary|Number of Urinary Urge Incontinent (UUI) Episodes Per Day - Randomized Portion|Urinary urge incontinent episodes were collected through a diary on daily basis for approximately 4 weeks when subjects were under each cycling setting. Only the last 7-day diaries were used for the analysis. The first 3 weeks were used as an adjustment period.|4 weeks|24 subjects who first completed the unique randomization sequences were included in the analysis.|||Number of UUI episodes/ Day||Standard Deviation|Mean
2620216|NCT01957111|Secondary|Sleep Efficiency Percentage on Overnight Sleep Study|Participants will have their sleep measured with polysomnography for one night. The sleep of individuals with insomnia will be compared to that of good sleepers. Sleep quality is defined as sleep efficiency, which is calculated at total sleep time / total time spent in bed x 100. It indicates the % of time spent asleep while in bed.|1 night||||% sleep efficiency||Standard Deviation|Mean
2620217|NCT01957111|Primary|Number of Metabolites Elevated Relative to the Other Group.|Metabolomics analysis of blood samples were carried out using Spectroscopy. This approach allows for rapid, unbiased and quantitative metabolic profiles ('fingerprints) to be acquired. A total of 70 metabolites were measured and compared between individuals with insomnia and good sleepers.|48 hours||||Number of metabolites elevated|||Number
2620218|NCT01957085|Other Pre-specified|Number of Evaluable Patients by Prior Visits to the Health System|Number of evaluable patients with at least one prior health system visit in the past 3 years by hepatitis C viremia|Single 24 hour period|Number of evaluable patients|||participants|||Number
2620219|NCT01957085|Other Pre-specified|Association Between Evaluable Viremic Patients and Length of Stay in the Hospital|Association between hepatitis C infection and the patient's length of stay in the hospital.|Single 24 hour period|Length of stay in days|||Days||95% Confidence Interval|Median
2620220|NCT01957085|Other Pre-specified|Number of Patients With Hepatitis C Viremia by Race and Ethnicity|Association between the incidence of hepatitis C infection by race and ethnicity|Single 24 hour period|Number of evaluable patients|||Participants|||Number
2620221|NCT01957085|Other Pre-specified|Number of Evaluable Patients With Hepatitis C Viremia by Gender|Association between the incidence of hepatitis C infection and gender.|Single 24 hour period|Number of evaluable patients|||participants|||Number
2620222|NCT01957085|Other Pre-specified|Number of Evaluable Participants Age 50 or Older and Point Prevalence of Hepatitis C Viremia|Association between point prevalence of hepatitis C viremia and evaluable participants age 50 or older.|Single 24 hour period|Number of patients with evaluable plasma|||participants|||Number
2620223|NCT01957085|Primary|Point Prevalence of Hepatitis C Infection|The point prevalence of hepatitis C infection in our hospitalized patients will be measured on a single day. All leftover plasma/serum samples will be de-identified and tested for hepatitis C antibody and if antibody positive will be tested for hepatitis C polymerase chain reaction. Results reported as percentage of subjects who are viremic.|Single 24 hour period||||percentage of total subjects|||Number
2620224|NCT01956773|Secondary|Number of Providers Who Were Successfully Using MeTree in Their Clinical Work Flow|Evaluate which providers were successfully using MeTree in their clinical work flow and which patients are successfully using MeTree for their care. (surveys, monitoring of clinical workflow, patient recruitment reflects underlying clinic population)|1 year||||Participants|||Count of Participants
2620225|NCT01956773|Secondary|Number of Physicians Who Gave Their Perceptions of Satisfaction and the MeTree Tool's Impact on Work Load|Evaluate physicians' perceptions of satisfaction, the MeTree tool's impact on work load and its effectiveness via survey and informal interviews at 3 months.|3 months|Consented providers who completed provider post implementation survey|||Participants|||Count of Participants
2620226|NCT01956773|Secondary|Number of Participants Reporting Preparedness When Using the MeTree Tool|The study will assess preparedness associated with using the MeTree tool via 3 months survey after completing the family health history collection. The participants were asked if they had enough information about some people in their family when completing MeTree|3 months|Patients who completed 3 months post survey and reported on preparedness|||Participants|||Count of Participants
2620227|NCT01956773|Secondary|Number of Participants Reporting Anxiety When Using the MeTree Tool|The study will assess anxiety associated with using the MeTree tool via 3 months survey after completing the family health history collection. The participant were asked if answering the questions made them anxious|3 months|Patients who completed 3 months post survey and reported on anxiety with answering the questions|||Participants|||Count of Participants
2620553|NCT01954160|Secondary|Renal Resistive Index|Intra-renal hemodynamics as measured by Renal Resistive Index (RRI) by renal Doppler ultrasonography Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2620231|NCT01956435|Secondary|Subject Self-reported Assessment of Re-pigmentation for Treated Lesions|Subject reported level of re-pigmentation for treated lesions was assessed by improvement from baseline using a scale from 1 - 4 with 1 being the least amount of re-pigmentation and 4 being the most re-pigmentation: 1 = Worsening of the light spots that were treated (the light spots seem to have gotten lighter or I have more light spots in the areas that were treated); 2 = No Improvement of the light spots (light spots have not changed since starting this study); 3 = Mild improvement of the light spots (there is some darkening of the light spots, but not in more than half of them); 4 = Moderate improvement (there is some darkening of the light spots in more than half of the light spots, but not more than 75% of them).|12 weeks|healthy adult patients with bilateral IGH lesions on lower extremities|||units on a scale||Standard Deviation|Mean
2620232|NCT01956435|Primary|Efficacy Outcome|Effectiveness will be graded by the blinded observer scal via photographic comparisons at the end of the study. Efficacy was assessed by improvement from baseline using the following scale: -1 = Worsening of IGH; 0 = No Improvement (IGH remained stable); 1 = Mild improvement of IGH (some re-pigmentation on <50% IGH); 2 = Moderate improvement (some re-pigmentation on >50% or full re-pigmentation on <75% IGH); 3 = Full re-pigmentation on >75% IGH.|12 weeks|healthy adult patients with bilateral IGH lesions on lower extremities|||units on a scale||95% Confidence Interval|Mean
2620233|NCT01956240|Secondary|Scapular Kinematics After Pectoralis Minor Stretching Protocol|The scapular kinematics will be evaluated with electromagnetic device. The changes in the scapular kinematics will be described in degrees.|6 weeks of stretching||||degree||Standard Deviation|Mean
2620234|NCT01956240|Primary|Pectoralis Minor Length After Pectoralis Minor Stretching Protocol|The change of the pectoralis minor muscle will be evaluated with a tape measure and electromagnetic device. The length of the muscle will be recorded in centimeters.|6 weeks after stretching||||centimeters||Standard Deviation|Mean
2620235|NCT01956123|Secondary|Technical Malfunctions of the Administration Pen for Each Controlled Ovarian Stimulation Cycle|Incidences of confirmed technical malfunction of administration pen are presented.|End-of-stimulation (up to 20 stimulation days)|Safety analysis set (all exposed subjects).|||Percentage of subjects|||Number
2620236|NCT01956123|Secondary|Proportion (Percentage) of Subjects With Late OHSS (Including OHSS of Moderate/Severe Grade) for Each Controlled Ovarian Stimulation Cycle|Late OHSS was defined as OHSS with onset >9 days after triggering of final follicular maturation.|>9 days after triggering of final follicular maturation|Safety analysis set (all exposed subjects).|||Percentage of subjects|||Number
2620237|NCT01956123|Secondary|Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Subject During the Stimulation Period for Each Controlled Ovarian Stimulation Cycle|Subjects self-assessed injection site reactions (redness, itching, pain, swelling and bruising) immediately, 30 minutes and 24 hours after each injection. The injection site reactions were assessed as none, mild, moderate and severe. The frequency of injection site reactions (mild, moderate or severe) based on all assessment performed is presented.|End-of-stimulation (up to 20 stimulation days)|Safety analysis set (all exposed subjects).|||Percentage of events|||Number
2620238|NCT01956123|Secondary|Ongoing Implantation Rate for Each Controlled Ovarian Stimulation Cycle|Ongoing implantation rate was defined as the number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts transferred.|10-11 weeks after blastocyst transfer|Subjects with blastocyst transfer. In COS cycle 2, a total of 254 and 271 blastocysts were transferred in the FE 999049 and GONAL-F groups, respectively. In COS cycle 3, a total of 132 and 121 blastocysts were transferred in the FE 999049 and GONAL-F groups, respectively.|||Percentage||95% Confidence Interval|Number
2620239|NCT01956123|Secondary|Ongoing Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle|Ongoing pregnancy rate was defined as at least one intrauterine viable fetus 10-11 weeks after blastocyst transfer.|10-11 weeks after blastocyst transfer|mITT analysis set (all exposed subjects). This is equivalent to FAS.|||Percentage of subjects||95% Confidence Interval|Number
2620240|NCT01956123|Secondary|Implantation Rate for Each Controlled Ovarian Stimulation Cycle|Implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by number of blastocysts transferred.|5-6 weeks after blastocyst transfer|Subjects with blastocyst transfer. In COS cycle 2, a total of 254 and 271 blastocysts were transferred in the FE 999049 and GONAL-F groups, respectively. In COS cycle 3, a total of 132 and 121 blastocysts were transferred in the FE 999049 and GONAL-F groups, respectively.|||Percentage||95% Confidence Interval|Number
2620241|NCT01956123|Secondary|Vital Pregnancy Rate for Each Controlled Ovarian Stimulation Cycle|Vital pregnancy was defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after blastocyst transfer.|5-6 weeks after blastocyst transfer|mITT analysis set (all exposed subjects). This is equivalent to the FAS.|||Percentage of subjects||95% Confidence Interval|Number
2620242|NCT01956123|Secondary|Proportion (Percentage) of Subject With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response for Each Controlled Ovarian Stimulation Cycle|Proportion (percentage) of subjects with cycle cancellation due to poor ovarian response, excessive ovarian response, and triggering with gonadotropin-releasing hormone (GnRH) agonist are presented.|End-of-stimulation (up to 20 stimulation days)|mITT analysis set (all exposed subjects). This is equivalent to the FAS.|||Percentage of subjects|||Number
2620243|NCT01956123|Secondary|Proportion (Percentage) of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS for Each Controlled Ovarian Stimulation Cycle|The proportion (percentage) of subjects with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS, early OHSS and/or preventive interventions for early OHSS, and early OHSS of moderate or severe grade and/or preventive interventions for early OHSS are presented.|≤9 days after triggering of final follicular maturation.|Modified intention-to-treat (mITT) analysis set (all exposed subjects). This is equivalent to the full analysis set (FAS).|||Percentage of subjects|||Number
2620244|NCT01956123|Secondary|Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralising Capacity, After One and After Two Repeated Controlled Ovarian Stimulation Cycles|The proportion (percentage) of subjects with treatment-induced anti-FSH antibodies, overall as well as with neutralising capacity, after one and after two repeated COS cycles is presented.|Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose|Safety analysis set (all exposed subjects).|||Percentage of subjects||95% Confidence Interval|Number
2620245|NCT01956123|Secondary|Proportion (Percentage) of Subjects With Treatment-induced Anti-FSH Antibodies With Neutralising Capacity After up to Two Repeated Controlled Ovarian Stimulation Cycles|The proportion (percentage) of subjects with treatment-induced anti-FSH antibodies with neutralising capacity at any time point is presented. The cumulative incidences in COS cycle 2 and COS cycle 3 divided by subjects in COS cycle 2 are presented. Subjects with observations in both cycles are only counted once.|Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose|Safety analysis set (all exposed subjects).|||Percentage of subjects||95% Confidence Interval|Number
2620246|NCT01956123|Primary|Proportion (Percentage) of Subjects With Treatment-induced Anti-Follicle-Stimulating Hormone (FSH) Antibodies After up to Two Repeated Controlled Ovarian Stimulation Cycles|The proportion (percentage) of subjects with at least one treatment-induced anti-FSH antibody response at any time point is presented. The cumulative incidences in COS cycle 2 and COS cycle 3 divided by subjects in COS cycle 2 are presented. Subjects with observations in both cycles are only counted once.|Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose|Safety analysis set (all exposed subjects).|||Percentage of subjects||95% Confidence Interval|Number
2620247|NCT01956110|Secondary|Technical Malfunctions of the Administration Pen|Confirmed technical malfunction of administration pen.|End-of-stimulation (up to 20 stimulation days)|Safety analysis set (all randomised and exposed subjects). This is equivalent to the mITT (FAS).|||Percentage of subjects|||Number
2620248|NCT01956110|Secondary|Proportion of Subjects With Late OHSS|Late OHSS was defined as OHSS with onset >9 days after triggering of final follicular maturation.The proportion of subjects with late OHSS, and late OHSS of moderate or severe grade are presented.|>9 days after triggering of final follicular maturation|Safety analysis set (all randomised and exposed subjects). This is equivalent to the mITT (FAS).|||Percentage of subjects|||Number
2620249|NCT01956110|Secondary|Proportion of Subjects With Treatment-induced Anti-follicle-stimulating Hormone (FSH) Antibodies|The proportion of subjects with at least one treatment-induced anti-FSH antibody response at any time point.|Stimulation day 1, 7-10 days after last FE 999049 or GONAL-F dose and 21-28 days after last FE 999049 or GONAL-F dose|Safety analysis set (all randomised and exposed subjects). This is equivalent to the mITT (FAS).|||Percentage of subjects||95% Confidence Interval|Number
2620250|NCT01956110|Secondary|Changes in Maximum Abdominal Circumference|Change in maximum abdominal circumference from baseline to end-of-stimulation and from baseline to day of blastocyst transfer.|End-of-stimulation and day of blastocyst transfer|Safety analysis set (all randomised and exposed subjects). This is equivalent to the mITT (FAS).|||Centimeter||Standard Deviation|Mean
2620251|NCT01956110|Secondary|Changes in Body Weight|Change in body weight from baseline to end-of-stimulation and from baseline to day of blastocyst transfer.|End-of-stimulation and day of blastocyst transfer|Safety analysis set (all randomised and exposed subjects). This is equivalent to the mITT (FAS).|||Kg||Standard Deviation|Mean
2620252|NCT01956110|Secondary|Abdominal Discomfort Related to Controlled Ovarian Stimulation as Assessed by a Visual Analogue Scale (VAS)|The subject self-assessed abdominal discomfort related to controlled ovarian stimulation using a VAS going from 0 mm (no abdominal discomfort) to 100 mm (worst imaginable abdominal discomfort).|End-of-stimulation and day of blastocyst transfer|Safety analysis set (all randomised and exposed subjects). This is equivalent to the mITT (FAS).|||Millimeter||Standard Deviation|Mean
2620253|NCT01956110|Secondary|Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Subject During the Stimulation Period|Subjects self-assessed injection site reactions (redness, itching, pain, swelling and bruising) immediately, 30 minutes and 24 hours after each injection. The injection site reactions were assessed as none, mild, moderate and severe. The frequency of injection site reactions (mild, moderate or severe) based on all assessments performed is presented.|End-of-stimulation (up to 20 stimulation days)|Safety analysis set (all randomised and exposed subjects). This is equivalent to the mITT (FAS).|||Percentage of events|||Number
2620254|NCT01956110|Secondary|Proportion of Subjects With Investigator-requested Gonadotropin Dose Adjustments||End-of-stimulation (up to 20 stimulation days)|mITT analysis set (all randomised and exposed subjects). This is equivalent to the FAS.|||Percentage of subjects|||Number
2620255|NCT01956110|Secondary|Number of Stimulation Days||End-of-stimulation (up to 20 stimulation days)|mITT analysis set (all randomised and exposed subjects). This is equivalent to the FAS.|||Days||Standard Deviation|Mean
2620256|NCT01956110|Secondary|Total Gonadotropin Dose|The total gonadotropin dose was recorded.|End-of-stimulation (up to 20 stimulation days)|mITT analysis set (all randomised and exposed subjects). This is equivalent to the FAS.|||µg of dose||Standard Deviation|Mean
2620257|NCT01956110|Secondary|Number and Quality of Blastocysts on Day 5|Number of blastocysts (total and good-quality) on Day 5 are presented. A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher.|On day 5 after oocyte retrieval|Subjects with oocytes retrieved.|||Number of blastocytss||Standard Deviation|Mean
2620258|NCT01956110|Secondary|Number and Quality of Embryos on Day 3|Number of embryos (total and good-quality) on Day 3 are presented. A good-quality embryo was defined as an embryo with ≥6 blastomeres and fragmentation ≤20% on Day 3.|On day 3 after oocyte retrieval|Subjects with oocytes retrieved.|||Number of embryos||Standard Deviation|Mean
2620259|NCT01956110|Secondary|Fertilisation Rate|Fertilisation rate was defined as the number of oocytes with 2 pronuclei divided by the number of oocytes retrieved.|Day 1 after insemination|Subjects with oocytes retrieved.|||Percentage of oocytes||Standard Deviation|Mean
2620260|NCT01956110|Secondary|Percentage of Metaphase II Oocytes (Oocytes Inseminated Using ICSI [Intracytoplasmic Sperm Injection])|Number of oocytes in metaphase II prior to ICSI insemination is presented.|Prior to insemination|Subjects with all oocytes inseminated using ICSI.|||Number of oocytes||Standard Deviation|Mean
2620261|NCT01956110|Secondary|Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved||Day of oocyte retrieval|Subjects who underwent triggering of final follicular maturation.|||Percentage of subjects|||Number
2620262|NCT01956110|Secondary|Number of Oocytes Retrieved||Day of oocyte retrieval|Subjects who underwent triggering of final follicular maturation.|||Oocytes retrieved||Standard Deviation|Mean
2620554|NCT01954160|Secondary|Urine Albumin|Urine albumin|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2620263|NCT01956110|Secondary|Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response|Proportion of subjects with cycle cancellation due to poor ovarian response, excessive ovarian response, and triggering with gonadotropin-releasing hormone (GnRH) agonist are presented.|End-of-stimulation (up to 20 stimulation days)|mITT analysis set (all randomised and exposed subjects). This is equivalent to the FAS.|||Percentage of subjects|||Number
2620264|NCT01956110|Secondary|Proportion of Subjects With Early OHSS (Ovarian Hyperstimulation Syndrome) and/or Preventive Interventions for Early OHSS|The proportion of subjects with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS, early OHSS and/or preventive interventions for early OHSS, and early OHSS of moderate or severe grade and/or preventive interventions for early OHSS are presented.|≤9 days after triggering of final follicular maturation|mITT analysis set (all randomised and exposed subjects). This is equivalent to the FAS.|||Percentage of subjects|||Number
2620265|NCT01956110|Secondary|Proportion of Subjects With Extreme Ovarian Responses, Defined as <4, ≥15 or ≥20 Oocytes Retrieved||Day of oocyte retrieval|Subjects who underwent triggering of final follicular maturation.|||Percentage of subjects|||Number
2620266|NCT01956110|Secondary|Implantation Rate|Implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by number of blastocysts transferred.|5-6 weeks after blastocyst transfer|Subjects with blastocyst transfer (a total of 585 and 584 blastocysts were transferred in the FE999049 and GONAL-F groups, respectively).|||Percentage|||Number
2620267|NCT01956110|Secondary|Vital Pregnancy Rate|Vital pregnancy was defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after blastocyst transfer.|5-6 weeks after blastocyst transfer|mITT analysis set (all randomised and exposed subjects). This is equivalent to the FAS.|||Percentage of subjects|||Number
2620268|NCT01956110|Primary|Ongoing Implantation Rate|Ongoing implantation rate was defined as the number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of blastocysts transferred.|10-11 weeks after blastocyst transfer|Subjects with blastocyst transfer (a total of 585 and 584 blastocysts were transferred in the FE999049 and GONAL-F groups, respectively).|||Percentage|||Number
2620269|NCT01956110|Primary|Ongoing Pregnancy Rate|Ongoing pregnancy was defined as at least one intrauterine viable fetus 10-11 weeks after blastocyst transfer.|10-11 weeks after blastocyst transfer|Modified intention-to-treat (mITT) analysis set (all randomised and exposed subjects). This is equivalent to full analysis set (FAS).|||Percentage of subjects|||Number
2620270|NCT01956097|Secondary|Number of Participants With Adverse Events||8th weeks|"6 participants in the HX106 590mg group and 2 participant in the HX106 1180mg were dropped out."|||number of participants|||Number
2620271|NCT01956097|Secondary|Number of Participants With Adverse Events||4th weeks|"3 participants in the HX106 590mg group and 1 participant in the HX106 1180mg were dropped out."|||number of participants|||Number
2620272|NCT01956097|Secondary|Number of Participants With Adverse Events||1st week|"2 participants in the HX106 590mg group and 1 participant in the HX106 1180mg were dropped out."|||number of participants|||Number
2620273|NCT01956097|Primary|Changes From Baseline in White Matter Integrity Assessment||Baseline, 8th weeks|||||||
2620274|NCT01956097|Primary|Changes From Baseline in Working Memory Domain Z-score|"To assess the working memory performance, four well-established tests, including the symbol span from the Wechsler Memory Scale-IV, immediate recall domain from the Rey-Osterrieth Complex Figure Test, digit span, and letter number sequencing from the Korean version of the Wechsler Adult Intelligence Scale were chosen.~Each test score was adjusted with age, sex, intelligent quotient, years of education, and baseline test scores. The adjusted test scores were then standardized into z-scores using all participants' means and standard deviations. The relative improvement (positive z-scores) or decline (negative z-scores) in performance was measured in a unit-free manner using the obtained z-scores. The individual z-scores of each test were averaged to the composite score for working memory domain."|Baseline, 8th week||||z-score||Standard Error|Mean
2620275|NCT01956071|Primary|Pedal Desk Trial Questionnaire|"Full-time sedentary workers used the pedal desk for 15 minutes while they: 1) searched the internet, 2) composed an email, and 3) completed acceptability ratings using an online Likert scale anchored from 1/strongly disagree to 5/strongly agree. The Questionnaire assessed subjective opinions about exercise and use of the Pedal Desk. No subscale or total scores were generated, and there are no maximum or minimum values. Rather, the number and proportion of participants who rated strongly agree, etc. on each item was calculated."|Visit 1||||Participants|||Count of Participants
2620276|NCT01956032|Secondary|Median Time Spent for Health Care Utilization Outside the TM Care Chain|The time spent in minutes for health care utilization outside the TM care chain was assessed. Data are presented as time in minutes with a minimum and maximum range.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Minutes||Full Range|Median
2620277|NCT01956032|Secondary|Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact|The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of contact (other, telephone, home or outpatient visit, and hospitalization).|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Number of participants|||Number
2620278|NCT01956032|Secondary|Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider|The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of health care provider (general practitioner, emergency ward, other neurologist, and other).|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Number of participants|||Number
2620555|NCT01954160|Secondary|Creatinine Clearance From 24-hour Urine Creatinine|Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2620279|NCT01956032|Secondary|Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms|CGI-I was used to document the Investigator's impression of the participant's improvement in Parkinson's Disease symptoms throughout the study. The CGI-I was measured on a 7-point scale: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse, where 1 through 3 indicated positive answers. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
2620280|NCT01956032|Secondary|DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 14 (How satisfied were you with replacing the participant home visit with TM communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
2620281|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 13 (Compared to classic titration at hospital - how much time did you spend on TM communication based on time for other tasks between contacts?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
2620282|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 12 (Compared to classic titration at hospital - how much time did you spend on TM communication based on booked communication time for participant contact?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
2620283|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 11 (Compared to classic titration at hospital - how much time did you spend on TM communication based on real communication time for participant contact?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
2620284|NCT01956032|Secondary|Positive (Investigator and DNS) Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: Did You Lack Any Dimensions in the Assessment of the Participant Using TM That You Have in the Classical Titration at Hospital?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'yes' or 'no' for question number 10 (Did you lack any dimensions in the assessment of the participant using TM that you have in the classical titration at hospital?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
2620285|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 9 (How satisfied were you with the participant contact when using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
2620286|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 8 (How satisfied were you regarding participant safety using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
2620287|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 7 (How satisfied were you with the setup and maintenance of the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
2620288|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 6 (How satisfied were you with the user interphase for the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
2620289|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 5 (How satisfied were you with the sound quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
2620290|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 4 (How satisfied were you with the image quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
2620291|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 3 (How satisfied were you with using TM for clinical assessments?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
2620292|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 2 (How satisfied were you with using TM for communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
2620343|NCT01955707|Secondary|Change in Infarct Volume From 24 Hours (FLAIR) to Day 30 (FLAIR)|Relative growth in infarct volume from Baseline (relative growth = FLAIR Day 30 divided by FLAIR at 24 hours ). Geometric mean calculated as the exponential of the mean log relative growth.|24 hours, Day 30|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.|||mL||Inter-Quartile Range|Geometric Mean
2620293|NCT01956032|Secondary|Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?|The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 1 (How satisfied were you with the TM concept comports with your clinical needs?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
2620294|NCT01956032|Secondary|Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 16 for Caregiver: Knowing What You Know Now, Would You Rather Have Had Your Spouse in the Hospital to Start Duodopa Treatment?|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days. The experience of Duodopa home titration using TM was measured by the caregiver as 'yes' or 'no' for question number 16 (knowing what you know now, would you rather have had your spouse in the hospital to start Duodopa treatment?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
2620295|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 15 (How confident did you feel about helping with the pump?) where 1 was ' Very unconfident' and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
2620296|NCT01956032|Secondary|Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 14 for Caregiver: Where You Able to Perform Daily Activities During the Titration Period?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver as 'yes' or 'no' for question number 14 (Where you able to perform daily activities during the titration period?) where 'yes' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
2620297|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 13 (how satisfied were you with the titration at the participant's home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
2620298|NCT01956032|Secondary|Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Knowing What You Know Now, Would You Rather Have Stayed in the Hospital to Start Duodopa Treatment?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as 'yes' or 'no' for question number 12 (Knowing what you know now, would you rather have stayed in the hospital to start Duodopa treatment?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
2620299|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 11 (How secure did you feel being at home and communicating by TM, when titrating Duodopa?) where 1 was 'very unsecure' and 7 was 'very secure'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
2620556|NCT01954160|Secondary|Blood Urea Nitrogen (BUN) Level|Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2620300|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 10 (How confident do you feel regarding the pump and the dose adjustments?) where 1 was ' very unconfident' and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
2620301|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 9 (How satisfied were you with the technician's visits to set up and dismantle the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
2620302|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 8 (How satisfied were you with having the technical equipment in your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
2620303|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 7 (How satisfied were you with the amount of time the DNS were at your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
2620304|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 6 (How satisfied were you with the 3-part video conversations with Investigator and DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
2620305|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 5 (How satisfied were you with the video conversation with your DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
2620306|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 4 (How satisfied were you with the video conversation with your Investigator?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
2620557|NCT01954160|Secondary|Serum Cystatin C|Study terminated early, endpoints not measured|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2620307|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 3 (How easy was the TM equipment to use?) where 1 was 'very hard' and 7 was 'very easy'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
2620308|NCT01956032|Secondary|Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: Did You do Things When at Home That You Could Not Have Done if You Were Hospitalized During the Titration?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as 'yes' or 'no' for question number 2 (Did you do things when at home that you could not have done if you were hospitalized during the titration?) where 'yes' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
2620309|NCT01956032|Secondary|Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa?|The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 1 (How satisfied were you with using TM when starting Duodopa?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS with non-missing information.|||Percentage of participants|||Number
2620310|NCT01956032|Secondary|Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence|Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the total number of technical events (34).|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of technical events|||Number
2620311|NCT01956032|Secondary|Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence|Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the number of participants in the FAS population.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
2620312|NCT01956032|Secondary|Incidence of Consequences Due to Technical Events|Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the total number of consequences (43).|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of consequences|||Number
2620313|NCT01956032|Secondary|Percentage of Participants With Consequences|Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the number of participants in the FAS population.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
2620314|NCT01956032|Secondary|Incidence of Technical Events Experienced by Participants|Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the total number of technical events (34).|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of technical events|||Number
2620315|NCT01956032|Secondary|Percentage of Participants Who Experienced Technical Events|Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the number of participants in the FAS population.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Percentage of participants|||Number
2620316|NCT01956032|Secondary|Median Total Free Time of Participant|Participant's daily free time was a maximum 24 hours, and was defined as the time spent on activities (e.g. work, household, chores, leisure time, travel, sleep, etc.) other than time spent on health care professional (the DNS and the Investigator) communication, dose adjustments and pump handling. Time for dose adjustments, health care professional communication via TM and pump handling were subtracted from the amount of participant's daily free time. The participant was asked to note the time used for independent dose adjustments and pump handling in a participant diary. Participant's total free time was calculated as the sum of participant's daily free time for all days during the titration period. Data are presented as time in minutes per participant with a minimum and maximum range.|From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Minutes||Full Range|Median
2620317|NCT01956032|Secondary|Median Total Time for Titration|The total time for titration period was defined as the number of minutes from the start of the pump after application of the naso-jejunal tube (Day 1) until Investigator's decision to terminate Duodopa treatment. Data are presented as time in minutes per participant with a minimum and maximum range.|From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Minutes||Full Range|Median
2620318|NCT01956032|Primary|Median Number of Contacts|Contacts (total, TM, telephone, home visit, and other) during the study period between the participant, the health care professional (the DNS and the Investigator) and TM technician were counted and summarized by type. Data are presented as number of contacts per participant with a minimum and maximum range.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using FAS, defined as all participants that started Duodopa titration.|||Number of contacts||Full Range|Median
2620319|NCT01956032|Primary|Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant|Health care professional time was defined as the number of minutes the individual had contact with the participant visiting their home, assisting with TM equipment, or by telephone. TM technician time was defined as the number of minutes spent for setup, demounting, and adjustments to the TM equipment. Data are presented as the time in minutes for communication between the following individuals and summarized by the type of contact (all types, TM, telephone, home visit, and other): (1) Participant + Investigator time; (2) Participant + DNS time; (3) Participant + Investigator + DNS time; (4) Participant + TM technician time; (5) Total Investigator time; (6) Total DNS time; and (7) Total participant time.|From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days|The analysis was performed using full analysis set (FAS), defined as all participants that started Duodopa titration.|||Minutes||Full Range|Median
2620320|NCT01955954|Secondary|Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week||Measured at 12 months post-treatment||||Participants|||Count of Participants
2620321|NCT01955954|Secondary|Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week||Measured at 2 months post-treatment||||Participants|||Count of Participants
2620322|NCT01955954|Secondary|Percent of Subjects Achieving Zero Panic Attacks Reported in Previous Week||Measured post-treatment (week-5)||||Participants|||Count of Participants
2620323|NCT01955954|Secondary|Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)|"The Panic Disorder Severity Scale (PDSS) (Shear, 1997) is a widely used assessment tool measuring panic disorder symptom severity and impact. Seven questions are scored from 0 to 4 giving minimum and maximum scores of zero and 28 respectively. Higher scores represent more severe impact of symptoms.~A 40% decrease has been reported to be clinically significant (Furukawa et al 2009) and is defined as Response in this study."|Measured at 12 months post-treatment.||||Participants|||Count of Participants
2620324|NCT01955954|Secondary|Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)|"The Panic Disorder Severity Scale (PDSS) (Shear, 1997) is a widely used assessment tool measuring panic disorder symptom severity and impact. Seven questions are scored from 0 to 4 giving minimum and maximum scores of zero and 28 respectively. Higher scores represent more severe impact of symptoms.~A 40% decrease has been reported to be clinically significant (Furukawa et al 2009) and is defined as Response in this study."|Measured post-treatment (week-5)||||Participants|||Count of Participants
2620325|NCT01955954|Primary|Percent of Subjects Achieving a 40% Decrease in Overall PDSS Score (Clinically Significant Response)|"The Panic Disorder Severity Scale (PDSS) (Shear, 1997) is a widely used assessment tool measuring panic disorder symptom severity and impact. Seven questions are scored from 0 to 4 giving minimum and maximum scores of zero and 28 respectively. Higher scores represent more severe impact of symptoms.~A 40% decrease has been reported to be clinically significant (Furukawa et al 2009) and is defined as Response in this study."|Measured at 2 months post-treatment.||||Participants|||Count of Participants
2620326|NCT01955733|Secondary|The Percentage of Patients Who Meet the EULAR Response [Good Response, Moderate Response, or no Response] [Based on DAS28 Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4|This outcome measure presents percentage of patients who meet the EULAR response [good response, moderate response, or no response] [based on DAS28 improvement since baseline in trial 1301.1] at Week 48 of trial 1301.4.|Week 48|FAS. Subjects who did not complete Week 48 are not presented.|||Percentage of patients|||Number
2620327|NCT01955733|Secondary|The Percentage of Patients Who Meet the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Definition of Remission [Based on Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4|"To meet the ACR/EULAR Remission criteria*, the subject needed to satisfy the following criteria:~TCJ (68 joints) < 1~SJC (66 joints) < 1~CRP < 1 milligrams per decilitre~patient global assessment < 10. The patient global assessment for the definition of ACR/EULAR Remission was defined with a visual analog scale in millimetres (0-100).** The number of subjects meeting the ACR/EULAR Remission definition at Week 48 is presented."|Baseline in clinical trial 1301.1 up to Week 48 in clinical trial 1301.4.|The FAS consisted of all patients from the randomised set of clinical trial 1301.1 who received at least one dose of trial medication and had data recorded for at least 1 DAS28 (ESR or CRP) or ACR20.|||Percentage of patients|||Number
2620328|NCT01955733|Secondary|The Percentage of Patients Meeting the ACR20 [Based on Improvement Since Baseline in Trial 1301.1] at Week 48 of Trial 1301.4|"A subject has an ACR20 response if all of the following occur:~a > 20% improvement in the swollen joint count (66 joints)~a > 20% improvement in the tender joint count (68 joints)~a > 20% improvement in at least 3 of the following assessments: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function, as measured by the Health Assessment Questionnaire - Disability Index, or Acute phase reactant (CRP).~The number of subjects meeting the ACR20 response criteria at Week 48 is presented."|Baseline in clinical trial 1301.1 up to Week 48 in clinical trial 1301.4.|The FAS consisted of all subjects from the randomised set of clinical trial 1301.1 who received at least one dose of trial medication and had data recorded for at least 1 DAS28 (ESR or CRP) or ACR20.|||Percentage of patients|||Number
2620329|NCT01955733|Secondary|Change From Baseline in Clinical Trial 1301.1 in Disease Activity Score 28 (DAS28) (Erythrocyte Sedimentation Rate [ESR]) at Week 48 of Clinical Trial 1301.4|"DAS-28 (ESR)** is an index containing a 28-joint count for tenderness (TJC28), 28 joint count for swelling (SJC28), natural logarithm of ESR (inflammation) (Ln[ESR]) and a general health component (GH) which is the patient's global assessment of disease activity and was used to describe the severity of RA. The DAS28 (ESR) Score is calculated as:~DAS28(ESR) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.70*ln(ESR) + 0.014*(GH). DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. A clinically important change in DAS28 score is defined as an improvement in DAS28 score of at least 1.2.~The mean change from baseline (in clinical trial 1301.1) at Week 48 in the DAS28 (ESR) score is presented."|Baseline in clinical trial 1301.1 up to Week 48 in clinical trial 1301.4.|The Full Analysis Set (FAS) consisted of all subjects from the randomised set of clinical trial 1301.1 who received at least one dose of trial medication and had data recorded for at least 1 DAS28 (ESR or C-reactive Protein [CRP]) or American College of Rheumatology 20% response criteria (ACR20).|||Units on Scale||90% Confidence Interval|Least Squares Mean
2620330|NCT01955733|Primary|The Percentage of Patients With Drug Related Adverse Events During the Treatment Phase|This outcome measure presents percentage of patients with drug related adverse events during the treatment phase. Treatment Emergent Adverse Events (TEAEs) were defined as Adverse Events (AEs) that started or worsened in severity on or after the first dose of trial medication in this extension study [1301.4] and prior to the last date of trial medication + 180 days [inclusive]. Drug-related events were those considered by the investigator to have a causal relationship to trial medication.|Week 48|Safety Randomized Analysis Set (SAFRD): All subjects randomized in 1301.1 [excluding open-label safety run-in subjects of trial 1301.1] who receive at least one dose of trial medication and subjects will be classified according to treatment received in trial 1301.1. 2 subjects from 1301.1 safety run-in also received treatment in 1301.4, thus 88.|||Percentage of patients|||Number
2620331|NCT01955720|Secondary|Ae0-6 (Amount of Ida Eliminated in Urine From the Time Point 0 to Time Point 6 h)|"Ae0-6 (Amount of Ida Eliminated in Urine From the Time Point 0 to Time point 6 h).~PK Urine sampling time:~Urine sampling relative to DE administration: Planned times 72:00 - 73:55h, 73:55 - 80:00h, 80:00 - 86:00h, 86:00 - 98:00h, 98:00 - 122:00h, 122:00 - 146:00h; additional sampling for renal impaired: 146:00 - 170:00; 170:00 - 194:00h."|from 0 to 6 hours of post Ida dose (details in description)|PKS-Ida: The PKS-Ida included all treated subjects who have received at least 1 dose of idarucizumab and who provided data for at least 1 secondary or other PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by (important) protocol violations relevant to the statistical evaluation of PK endpoints.|||umol||Geometric Coefficient of Variation|Geometric Mean
2620332|NCT01955720|Secondary|Cmax (Maximum Measured Concentration of the Ida in Plasma)|"Cmax. PK/PD sampling time: (p=predose, D=day)~single medium or high dose, HS mid-age (45-64 yrs): D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00p, 21:00. D6: 9:00.~single low or high dose, healthy elderly or mild RI: D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for RI: D8: 9:00;D9: 9:00.~high 2 doses, moderate RI: D4: 8:55p, 9:00, 9:10,9:30,9:55p, 10:00,10:10,10:30,11:00, 13:00, 15:00, 19:00, 21:00, 01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for RI: D8:9:00; D9:9:00."|From Ida administration to 4 days post dose (details in description)|PKS-Ida|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2620333|NCT01955720|Secondary|Aet1-t2, ss (Amount of DE Eliminated in Urine From the Time Point t1 to Time Point t2)|"Urinary excretion of sum dabigatran from the time point t1 to t2 at steady state.~PK Urine sampling time:~Urine sampling relative to first DE administration: Planned times 72:00 - 73:55h, 73:55 - 80:00h, 80:00 - 86:00h, 86:00 - 98:00h, 98:00 - 122:00h, 122:00 - 146:00h; additional sampling for renal impaired: 146:00 - 170:00; 170:00 - 194:00h.~Ae0-26,ss was not measured in Period 3 (re-exposure period). Ae0-74,ss was not measured in healthy subjects aged 45 to 64 years."|From 0 to 74h post of last DE dose (details in description)|Pharmacokinetic Set - DE (PKS-DE): The PKS-DE included all treated subjects who have received at least 1 dose of DE and who provided data for at least 1 secondary or further PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints.|||μg||Geometric Coefficient of Variation|Geometric Mean
2620344|NCT01955707|Secondary|Change in Infarct Volume From 24 Hours (FLAIR) to Day 5 (FLAIR)|Relative growth of infarct volume from 24 hours (relative growth = FLAIR at Day 5 divided by FLAIR at 24 hours). Geometric mean calculated as the exponential of the mean log relative growth.|24 hours, Day 5|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.|||mL||Inter-Quartile Range|Geometric Mean
2620334|NCT01955720|Secondary|AUC2-12, ss (Area Under the Concentration-time Curve of Unbound Sum Dabigatran (DE) in Plasma at Steady State Over the Time Interval From 2 to 12h)|"PK/PD sampling time:(d=dose,D=Day,p=predose)~single medium or high dose,healthy, mid-age (45-64 yrs): D4: 7:00p,8:55p,9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00, 01:00; D5:9:00p,11:00,21:00p; D6:9:00p, 21:00p; D7:9:00p, 11:00.~single low or high dose,healthy elder or mild renal impaired: D4:7:00p,8:55p,9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00;D5:9:00;D6:9:00;D7:9:00; additional sampling for renal impaired: D8:9:00;D9:9:00.~high 2 doses, moderate renal impaired: D4:7:00p,8:55p,9:00,9:10,9:30,9:55p,10:00,10:10,10:30,11:00,13:00,15:00,19:00,21:00,01:00;D5:9:00;D6:9:00; D7:9:00; additional sampling for renal impaired: D8:9:00;D9:9:00."|from 2h to12h of post DE dose at steady state (details in description)|PKS-DE: The PKS-DE included all treated subjects who have received at least 1 dose of DE and who provided data for at least 1 secondary or further PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by (important) protocol violations relevant to the statistical evaluation of PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2620335|NCT01955720|Secondary|AUC0-infinity (Area Under the Concentration-time Curve of Idarucizumab (Ida) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"AUC0-infinity. PK/PD sampling time: (p=predose, D=day)~single medium or high dose, healthy subjects(HS) mid-age (45-64 yrs): D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00p, 21:00. D6: 9:00.~single low or high dose, HS elderly or mild renal impaired: D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for renal impaired: D8: 9:00;D9: 9:00.~high 2 doses, moderate renal impaired: D4: 8:55p, 9:00, 9:10,9:30,9:55p, 10:00,10:10,10:30,11:00, 13:00, 15:00, 19:00, 21:00, 01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for renal impaired: D8:9:00; D9:9:00."|From Day 4 to Day 9 (details in description)|Pharmacokinetic Set -Ida (PKS-Ida): included all treated subjects who have received at least 1 dose of idarucizumab and who provided data for at least 1 secondary or other PK endpoint in any treatment period, which was judged as evaluable for PK and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2620336|NCT01955720|Primary|The Percentage of Subjects With Drug-related Adverse Events|The percentage of subjects with possibly drug-related AEs (as defined by the investigator) during the treatment period.|From baseline up to the start of follow-up period (from Day 1 to Day 35)|Treated Set (TS): All randomised subjects who received at least 1 dose of trial medication were included in the treated set.|||percentage of participants|||Number
2620337|NCT01955720|Primary|Reversal of Dabigatran-induced Prolongation of Blood Coagulation Time|Percentage of subjects with at least one assay value from diluted thrombin time (dTT) or ecarin clotting time (ECT) reversed within 10min after completion of infusion. Reversal was defined as return to baseline, where the threshold for reversal to baseline was determined using PK/PD correlation between unbound sum dabigatran and the clotting parameters ECT and dTT. Measured at the end of the infusion and 10 min later.|End of last infusion and 10 minutes after completion of last infusion of BI 655075|PD Set (PDS): The PDS included all subjects from the TS who had at least 1 evaluable predose and on-treatment coagulation test measurement value for at least 1 coagulation test and who did not have important protocol violation relevant to the evaluation of PD.|||percentage of participants|||Number
2620338|NCT01955707|Secondary|Number of Participants Who Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Events were categorized as severe, moderate, or mild, and related or not related to study treatment.|Up to Day 90 ± 5 days|Safety population (all participants who were randomized and received any portion of the infusion of study treatment).|||participants|||Number
2620339|NCT01955707|Secondary|Barthel Index at Day 5, Day 30, and Day 90|The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility, and can be used to determine a baseline level of functioning and to monitor change in activities of daily living over time. The scores for each of the items are summed to create a total score up to a potential of 100, with higher scores representing a greater level of independence.|Day 5, Day 30, and Day 90|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment); n=participants with assessment at given time point.|||units on a scale||Full Range|Median
2620340|NCT01955707|Secondary|Modified Rankin Scale (mRS) Distribution at Day 5, Day 30, and Day 90|The mRS measures independence, rather than neurologic function, with specific tasks pre- and post-stroke, respectively. The scale consists of 7 grades, from 0 to 6, with 0 corresponding to no symptoms and 6 corresponding to death. The distribution of mRS scores was summarized at each timepoint. An excellent outcome on the mRS was defined as a score of 0 or 1, while a good outcome was defined as a score of 0, 1, or 2.|Day 5, Day 30, and Day 90|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment), using imputed data; n=number of participants with an assessment at given time point.|||participants|||Number
2620341|NCT01955707|Secondary|Change in National Institute of Health Stroke Scale (NIHSS) Score From Baseline to 24 Hours, Day 5, Day 30, and Day 90|The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. Scores for the NIHSS range from 0 to 42, with 0 representing no symptoms and 42 representing death.|Baseline, 24 hours, Day 5, Day 30, Day 90|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment); n=participants with assessments at Baseline and given time point.|||units on a scale||Standard Deviation|Mean
2620342|NCT01955707|Secondary|Change in Infarct Volume From Day 5 (FLAIR) to Day 30 (FLAIR)|Relative growth of infarct volume from Day 5 (relative growth = FLAIR at Day 30 divided by FLAIR at Day 5). Geometric mean calculated as the exponential of the mean log relative growth.|Day 5, Day 30|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.|||mL||Inter-Quartile Range|Geometric Mean
2620345|NCT01955707|Secondary|Change in Infarct Volume From Baseline (DWI) to Day 30 (FLAIR)|Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 30 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.|Baseline, Day 30|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.|||mL||Inter-Quartile Range|Geometric Mean
2620346|NCT01955707|Secondary|Change in Infarct Volume From Baseline (DWI) to 24 Hours (FLAIR)|Relative growth of infarct volume from Baseline (relative growth = FLAIR at 24 hours divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.|Baseline, 24 hrs|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.|||mL||Inter-Quartile Range|Geometric Mean
2620347|NCT01955707|Primary|Change in Infarct Volume From Baseline (Diffusion-Weighted Imaging [DWI]) to Day 5 (Fluid-Attenuated Inversion Recovery [FLAIR])|Relative growth of infarct volume from Baseline (relative growth = FLAIR at Day 5 divided by Baseline DWI). Geometric mean calculated as the exponential of the mean log relative growth.|Baseline, Day 5|Modified intention to treat (all participants who were randomized and received the entire infusion of study treatment) with assessments at both time points.|||mL||Inter-Quartile Range|Geometric Mean
2620348|NCT01955629|Secondary|Part 2: Aflibercept Biomarkers Evaluation|Blood and tumor samples were to be collected to evaluate proteomic biomarkers such as factors and receptors related to angiogenesis process, inflammation, and tumor progression.|Baseline (within 21 days before registration); Day 1/pre-dose of Cycle 1, 2 and 3 of induction phase and maintenance phase; 30 ± 3 days after the last aflibercept administration.|Due to premature recruitment discontinuation, no samples had been collected and none of the planned biomarker analyses was performed.||||||
2620349|NCT01955629|Secondary|Part 2: Pharmacodynamic Parameters: Modulation of Circulating Analytes|Blood and tumor samples were to be collected to evaluate the pharmacodynamic parameters including the assessment of the modulation of circulating analytes such as cytokines and angiogenic factors.|Baseline (within 21 days before registration); Day 1/pre-dose of Cycle 1, 2 and 3 of induction phase and maintenance phase; 30 ± 3 days after the last aflibercept administration.|Due to premature recruitment discontinuation, no samples had been collected and none of the planned efficacy/pharmacodynamic analyses was performed.||||||
2620350|NCT01955629|Secondary|Part 2: Number of Participants With CR or PR|Tumor assessment was performed by abdomino-pelvic computed tomography scan or MRI and chest X-ray or chest CT-scan to assess the disease status at baseline and then every 9 weeks during study treatment up to DP. Target lesions were evaluated using RECIST version 1.1, wherein CR = disappearance of all target lesions; PR = 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.|Baseline and every 9 weeks up to end of study completion (15 months).|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.||||||
2620351|NCT01955629|Secondary|Part 2: Overall Rate of Resectability of Metastatic Lesions|Overall metastases resection rate was defined as the percentage of participants reaching an R0 metastases resection, defined as the complete absence of invasive carcinoma on histological examination at the time of definitive surgery.|12 months after the last participant enrolled.|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.||||||
2620352|NCT01955629|Secondary|Part 2: Overall Survival (OS)|OS was defined as the time interval from the date of registration into the study to the date of death due to any cause. In the absence of confirmation of death, survival time was to be censored at the earliest between the last date the participant was known to be alive and the end of study date.|From the date of enrollment up to the date of death (up to 15 months).|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.||||||
2620353|NCT01955629|Secondary|Part 2: Progression Free Survival (PFS)|PFS was defined as the time interval from the date of registration into the study to the date of first observation of DP or death (due to any cause), whichever was first.|From the date of enrollment up to the date of DP or death, whichever occurred first (up to 15 months).|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.||||||
2620354|NCT01955629|Secondary|Part 1: Number of Participants With Tumor Responses (Complete Response [CR], Partial Response [PR], Stable Disease [SD] or Progressive Disease [PD])|Tumor assessment was performed by abdomino-pelvic computed tomography scan or magnetic resonance imaging (MRI) and chest X-ray or chest CT-scan to assess the disease status at baseline and then every 9 weeks during study treatment up to DP. Target lesions were evaluated using response evaluation criteria in solid tumors (RECIST) version 1.1, wherein CR = disappearance of all target lesions; PR = 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD; PD =20% increase in the sum of the LD of target lesions taking as reference the smallest sum in the study and SD = small changes that did not meet above criteria.|Baseline and every 9 weeks up to DP (up to 15 months).|Evaluable Population (EP) for tumor response was defined as a subset of ITT population (all participants who gave their informed consent and successfully registered into study) with measurable disease at study entry, who received at least 1 cycle of study treatment, with at least 1 post baseline tumor evaluation, except for early DP or death.|||Participants|||Number
2620355|NCT01955629|Primary|Part 2: Number of Participants With Progression Free Survival (PFS) at 6 Months After the Start of Maintenance Therapy|It describes the number of participants alive without progression at 6 months after the start of Aflibercept maintenance therapy.|6 months after the start of maintenance therapy.|Due to premature recruitment discontinuation, none of the planned efficacy analyses was performed.||||||
2620373|NCT01955473|Secondary|Dose Normalized Maximum Serum Concentration (Cmax) of Sym004 for the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized Cmax are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment. Dose normalized Cmax was calculated as Cmax/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004.|||μg/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2620356|NCT01955629|Primary|Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)|DLTs were assessed using the national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 4.03. DLTs were defined as any of following AEs: grade 4 neutropenia lasting >7 consecutive days; febrile neutropenia or neutropenic infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia associated with bleeding requiring transfusion; grade 4 non-hematological treatment related event; grade 3 nausea/vomiting or diarrhea lasting >/= 4 days despite corrective measures; grade 3 other non-hematological toxicities: anorexia, fatigue, hypertension only if G4 or not medically controlled and G3 peripheral sensory neuropathy that did not improve to G<2 at time of retreatment; urinary protein excretion of >3.5 gram per 24 hours that did not recover to <2.0 gram per 24 hours within 2 weeks; symptomatic arterial thromboembolic events including cerebrovascular accidents, myocardial infarction, transient ischemic attacks, new onset or worsening of pre-existing angina.|Cycle 1 (Up to 3 weeks)|Evaluable DLT population defined as the subset of the whole part 1 participants that were exposed to at least 1 dose (even incomplete) of the study treatment and had a DLT assessment at Cycle 1.|||Participants|||Number
2620357|NCT01955564|Secondary|Total Drug Exposure Over Time (AUC0-t) of NW-3509A at Doses Tested|"Plasma concentration data, derived PK parameters, and urine data were summarized as total drug exposure over time (AUC0-t).~The plasma concentrations of NW‑3509A in the samples taken from the subjects receiving placebo were below the limit of quantification (<1.00 ng/mL) in all cases (n=18)."|Baseline up to 32 hours post-dose||||ng.h/mL||Standard Deviation|Mean
2620358|NCT01955564|Secondary|Maximum Plasma Concentration of NW-3509A at Doses Tested|"Plasma concentration data, derived PK parameters, and urine data are summarized as maximum plasma concentration (Cmax).~The plasma concentrations of NW‑3509A in the samples taken from the subjects receiving placebo were below the limit of quantification (<1.00 ng/mL) in all cases (n=18)."|Baseline up to 32 hours post-dose||||ng/mL||Standard Deviation|Mean
2620359|NCT01955564|Primary|Physical Examination Shift Table|Physical examinations were carried out on the following: Lymph nodes, mouth, neck, nervous system, nose, skin and throat.|Day -1(pre-dose) through Day 8 (Discharge)||||Participants abnormal at end of study|||Number
2620360|NCT01955473|Secondary|Percentage of Participants With EGFR Amplification Using Fluorescent in Situ Hybridization (FISH) Method.||Week 1 (pre-dose) and Week 4.|The Biomarker analysis set consisted of all subjects who received at least 1 administration of Sym004 and who had at least 1 biomarker evaluation.|||percentage of subjects|||Number
2620361|NCT01955473|Secondary|Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression in Skin Tissues by Immunohistochemistry (IHC)|IHC is a staining process performed on fresh/frozen cancer tissue. IHC is used to show whether or not the cancer cells have Human Epidermal Growth Receptor (HER2) and/or hormone receptors on their surface. A value designated the IHC score was derived by summing the percentages of cells staining at each intensity multiplied by the weighted intensity of staining (0, 1+, 2+, 3+: 3+ indicates the strongest staining, 2+ indicates medium staining, 1+ indicates weak staining, and 0 indicates no staining). Minimum score of 0 to a maximum score of 300; the maximum score indicates the strongest expression.|Week 1 (pre-dose), Week 4 and Week 5|The Biomarker analysis set consisted of all subjects who received at least 1 administration of Sym004 and who had at least 1 biomarker evaluation.|||percentage of subjects|||Number
2620362|NCT01955473|Secondary|Anti-drug Antibody Titers||Week 1 (pre-dose) up to Follow-up assessment (up to maximum 45.1 Weeks)|Anti-drug Antibody (ADA) titer could not be estimated because there were no subjects who were confirmed to have ADA positive test results during the confirmatory analysis.||||||
2620363|NCT01955473|Secondary|Progression-free Survival Time|The Progression-free survival time was measured from the date of subject enrollment until the date that disease progression was objectively documented or death. Progression-free survival time estimated with using the Kaplan-Meier method. Progression-free survival time was planned to be reported for Part B alone and Part A/B combined reporting arms.|Time from enrollment until the date of objectively documented disease progression or death, up to 45.1 Weeks|Efficacy Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who had baseline tumor assessment and at least 1 tumor assessment according to RECISTv1.1 after first dose of trial medication.|||months||95% Confidence Interval|Median
2620364|NCT01955473|Secondary|Time to Progression|Time to progression was defined as the time from date of subject enrollment until the date that disease progression was objectively documented. TTP estimated using the Kaplan-Meier estimates. TTP was planned to be reported for Part B alone and Part A/B combined reporting arms.|Time from enrollment until the date of objectively documented disease progression or death, up to 45.1 Weeks|Efficacy Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who had baseline tumor assessment and at least 1 tumor assessment according to RECISTv1.1 after first dose of trial medication.|||months||95% Confidence Interval|Median
2620365|NCT01955473|Secondary|Duration of Disease Control|Duration of disease control measured from the time measurement criteria were first met for CR, PR, or SD (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented. CR: disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Week 7 and thereafter every 6 weeks until the first date of objectively documented recurrent or progressive disease, up to 45.1 weeks|Efficacy Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who had baseline tumor assessment and at least 1 tumor assessment according to RECISTv1.1 after first dose of trial medication. Here, “Number of Participants Analyzed” signifies those subjects who achieved disease control.|||Weeks||Full Range|Median
2620432|NCT01955122|Secondary|Sedation|Sedation dosage|During the procedure|Sedation dosage was not collected from any participant during the study||||||
2620558|NCT01954160|Secondary|Glomerular Filtration Rate|Estimated Glomerular Filtration Rate (GFR) by creatinine and cystatin C|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2620366|NCT01955473|Secondary|Percentage of Subjects With Disease Control|Percentage of subjects with disease control (defined as confirmed CR, confirmed PR, or confirmed SD) ) according to RECIST Version 1.1 was reported. CR: disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Confirmed CR or PR: response confirmed at an interval of at least 4 weeks. Confirmed SD: response confirmed at an interval of at least 6 weeks.|Week 7 and thereafter every 6 weeks, up to 4 weeks after last dose for Part A or up to 8 weeks after the last dose for Part B (up to 45.1 Weeks)|Efficacy Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who had baseline tumor assessment and at least 1 tumor assessment according to RECISTv1.1 after first dose of trial medication.|||percentage of subjects||95% Confidence Interval|Number
2620367|NCT01955473|Secondary|Duration of Overall Response|The duration of overall response was measured from the time measurement criteria were first met for CR or PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented. CR was defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Confirmed CR or PR was defined as the response that was confirmed at an interval of at least 4 weeks.|Week 7 and thereafter every 6 weeks until the first date of objectively documented recurrent or progressive disease, up to 45.1 Weeks|Efficacy Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who had baseline tumor assessment and at least 1 tumor assessment according to RECISTv1.1 after first dose of trial medication. Here, “Number of Participants Analyzed” signifies those subjects who achieved confirmed CR or PR.|||Weeks||Full Range|Median
2620368|NCT01955473|Secondary|Percentage of Subjects With Best Overall Response|Percentage of subjects with best overall response (defined as confirmed CR or PR) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) was reported. CR was defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimiter (mm). PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Confirmed CR or PR was defined as the response that was confirmed at an interval of at least 4 weeks.|Week 7 and thereafter every 6 weeks, up to 4 weeks after last dose for Part A or up to 8 weeks after the last dose for Part B (up to 45.1 Weeks)|Efficacy Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who had baseline tumor assessment and at least 1 tumor assessment according to RECISTv1.1 after first dose of trial medication.|||percentage of subjects|||Number
2620369|NCT01955473|Secondary|Time to Reach Maximum Concentration (Tmax) of Sym004 for the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Tmax are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004.|||hours||Full Range|Median
2620370|NCT01955473|Secondary|Time to Reach Maximum Concentration (Tmax) of Sym004 for the Weekly Regimen at Week 4: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Tmax are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||hours||Full Range|Median
2620371|NCT01955473|Secondary|Time to Reach Maximum Concentration (Tmax) of Sym004 at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Tmax are presented for both monoclonal antibodies.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||hours||Full Range|Median
2620372|NCT01955473|Secondary|Trough Concentrations (Ctrough) of Sym004|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Ctrough are presented for both monoclonal antibodies.|Pre-infusion at Week 2, 3, 5, 6, 7, 8, End of Trial (up to 41.1 weeks) and Follow up (up to 45.1 Weeks)|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified time frame."|||μg/mL||Standard Deviation|Mean
2620449|NCT01955044|Secondary|Resolvin Levels|resolvin, a metabolite of LCPUFA, will be measured at 2 weeks of life.|2 weeks of life||2018-02-28|02/2018||||
2620450|NCT01955044|Secondary|Resolvin Levels|Resolvin, a metabolite of LCPUFA, will be measured at 8 weeks of life.|8 weeks of life||2018-02-28|02/2018||||
2620451|NCT01955044|Secondary|LCPUFA Levels|LCPUFA levels will be measured at 8 weeks of life.|8 weeks of life||||wt% (g/100g)||Inter-Quartile Range|Median
2620374|NCT01955473|Secondary|Dose Nornamized Maximum Serum Concentration (Cmax) of Sym004 for the Weekly Regimen at Week 4: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized Cmax are presented for both monoclonal antibodies. Dose normalized Cmax was calculated as Cmax/Dose. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||μg/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2620375|NCT01955473|Secondary|Dose Normalized Maximum Serum Concentration (Cmax) of Sym004 at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Dose Normalized Cmax are presented for both monoclonal antibodies. Dose normalized Cmax was calculated as Cmax/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||μg/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2620376|NCT01955473|Secondary|Maximum Serum Concentration (Cmax) of Sym004 for the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Cmax are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2620377|NCT01955473|Secondary|Maximum Serum Concentration (Cmax) of Sym004 for the Weekly Regimen at Week 4: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Cmax are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2620378|NCT01955473|Secondary|Maximum Serum Concentration (Cmax) of Sym004 at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Cmax are presented for both monoclonal antibodies.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||microgram per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2620379|NCT01955473|Secondary|Volume of Distribution at Steady State (Vss) of Sym004 for the Biweekly Regimen at Week 5: Multiple Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug needed to be uniformly distributed to produce the desired serum concentration of a drug. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Vss are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||Liter||Geometric Coefficient of Variation|Geometric Mean
2620380|NCT01955473|Secondary|Volume of Distribution at Steady State (Vss) of Sym004 for the Weekly Regimen at Week 4: Multiple Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug needed to be uniformly distributed to produce the desired serum concentration of a drug. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Vss are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."|||Liter||Geometric Coefficient of Variation|Geometric Mean
2620452|NCT01955044|Primary|Long-chain Polyunsaturated Fatty Acid (LCPUFA) Levels|LCPUFA levels will be measured at 2 weeks of life in extremely low birth weight (ELBW) infants|2 weeks of life|2 subjects died prior to having 2 week levels drawn, from causes unrelated to study.|||weight % (g/100g)||Inter-Quartile Range|Median
2620381|NCT01955473|Secondary|Volume of Distribution at the Elimination Phase (Vz) of Sym004 at Week 1: Single Dose|Volume of distribution was defined as the theoretical volume in which the total amount of drug needed to be uniformly distributed to produce the desired serum concentration of a drug. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Vz are presented for both monoclonal antibodies.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."|||Liter||Geometric Coefficient of Variation|Geometric Mean
2620382|NCT01955473|Secondary|Clearance at Steady-state (CLss) of Sym004 for the Biweekly Regimen at Week 5: Multiple Dose|Clearance at steady state was reported. Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). CLss are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||Liter/hour||Geometric Coefficient of Variation|Geometric Mean
2620383|NCT01955473|Secondary|Clearance at Steady-state (CLss) of Sym004 for the Weekly Regimen at Week 4: Multiple Dose|Clearance at steady state was reported. Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). CLss are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."|||Liter/hour||Geometric Coefficient of Variation|Geometric Mean
2620384|NCT01955473|Secondary|Clearance (CL) of Sym004 at Week 1: Single Dose|Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). CL are presented for both monoclonal antibodies.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."|||Liter/hour||Geometric Coefficient of Variation|Geometric Mean
2620385|NCT01955473|Secondary|Terminal Half-life (t1/2) of Sym004 For the Biweekly Regimen at Week 5: Multiple Dose|Terminal half-life was defined as the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Terminal t1/2 are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||hours||Geometric Coefficient of Variation|Geometric Mean
2620386|NCT01955473|Secondary|Terminal Half-life (t1/2) of Sym004 for the Weekly Regimen at Week 4: Multiple Dose|Terminal half-life was defined as the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Terminal t1/2 are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."|||hours||Geometric Coefficient of Variation|Geometric Mean
2620387|NCT01955473|Secondary|Terminal Half-life (t1/2) of Sym004 at Week 1: Single Dose|Terminal half-life was defined as the time required for the serum concentration of drug to decrease 50 percent in the final stage of its elimination. Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Terminal t1/2 are presented for both monoclonal antibodies.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."|||hours||Geometric Coefficient of Variation|Geometric Mean
2620388|NCT01955473|Secondary|Dose Normalized Area Under Concentration-time Curve (AUC) From Start of First Infusion to Infinity (AUC0-inf) For the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were not applicable for Week 5 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was only applicable for Week 5 assessment. Dose normalized AUC for AUC0-inf was calculated as AUC(0-inf)/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2620389|NCT01955473|Secondary|Dose Normalized Area Under Concentration-time Curve (AUC) From Start of First Infusion to Infinity (AUC0-inf) for the Weekly Regimen at Week 4: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) were only applicable for Week 4 assessment. Biweekly dosing cohort (Part A: Sym004 18 mg/kg) was not applicable for Week 4 assessment. Dose normalized AUC for AUC0-inf was calculated as AUC(0-inf)/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."|||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2620390|NCT01955473|Secondary|Dose Normalized Area Under Concentration-time Curve (AUC) From Start of First Infusion to Infinity (AUC0-inf) at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Dose normalized AUC for AUC0-inf was calculated as AUC(0-inf)/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24, and 48 hours post-infusion at Week 1|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."|||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2620391|NCT01955473|Secondary|Area Under Concentration-time Curve (AUC) From Start of First Infusion to Infinity (AUC0-inf) For the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here AUC are presented for both monoclonal antibodies. Results were to be assessed for biweekly dosing cohort (Part A: Sym004 18 mg/kg) only.|Pre-infusion, end of infusion, 4, 8, 12 and 24 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here, Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2620392|NCT01955473|Secondary|Area Under Concentration-time Curve (AUC) From Start of First Infusion to Infinity (AUC0-inf) For the Biweekly Regimen at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here AUC are presented for both monoclonal antibodies. Results were to be assessed for biweekly dosing cohort (Part A: Sym004 18 mg/kg) only.|Pre-infusion, end of infusion, 4, 8, 12, 24, and 48 hours post-infusion at Week 1|The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2620393|NCT01955473|Secondary|Dose Normalized Area Under Concentration-time Curve (AUC) From Start of First Infusion to 336 Hours (AUC0-336hours) For the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Results were to be assessed for biweekly dosing cohort (Part A: Sym004 18 mg/kg) only. Dose normalized AUC for AUC0-336 was calculated as AUC(0-336)/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24, 168 and 336 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here, Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2620394|NCT01955473|Secondary|Dose Normalized Area Under Concentration-time Curve (AUC) From Start of First Infusion to 336 Hours (AUC0-336hours) For the Biweekly Regimen at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Results were to be assessed for biweekly dosing cohort (Part A: Sym004 18 mg/kg) only. Dose normalized AUC for AUC0-336 was calculated as AUC(0-336)/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48, 168, 336 hours post-infusion at Week 1|The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004.|||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2620559|NCT01954160|Secondary|24-hour Urine Sodium Excretion|Difference in 24-hour urine sodium excretion, compared between pre-RSD and 13 weeks after RSD.|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2620560|NCT01954160|Secondary|Urine Volume|Urine volume following furosemide therapy after sodium loading.|13 Weeks following Renal Denervation|Study terminated early, data not collected and therefore endpoints were not measured.||||||
2620395|NCT01955473|Secondary|Area Under Concentration-time Curve (AUC) From Start of First Infusion to 336 Hours (AUC0-336hours) For the Biweekly Regimen at Week 5: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here AUC are presented for both monoclonal antibodies. Results were to be assessed for biweekly dosing cohort (Part A: Sym004 18 mg/kg) only.|Pre-infusion, end of infusion, 4, 8, 12, 24, 168 and 336 hours post-infusion at Week 5|"The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here, Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2620396|NCT01955473|Secondary|Area Under Concentration-time Curve (AUC) From Start of First Infusion to 336 Hours (AUC0-336hours) For the Biweekly Regimen at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here AUC are presented for both monoclonal antibodies. Results were to be assessed for biweekly dosing cohort (Part A: Sym004 18 mg/kg) only.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48, 168, 336 hours post-infusion at Week 1|The PK Analysis Set consisted of all subjects who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2620397|NCT01955473|Secondary|Dose Nornamized Area Under Concentration-time Curve (AUC) From Start of First Infusion to 168 Hours (AUC0-168h) for the Weekly Regimen at Week 4: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Dose normalized AUC for AUC0-168 was calculated as AUC(0-168)/Dose. Results were to be assessed for weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) only.|Pre-infusion, end of infusion, 4, 8, 12, 24, and 168 hours post-infusion at Week 4|"The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed =subjects who were evaluable for this outcome and n =subjects who were evaluable for specified monoclonal antibody."|||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2620398|NCT01955473|Secondary|Dose Normalized Area Under Concentration-time Curve (AUC) From Start of First Infusion to 168 Hours (AUC0-168h) at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here dose normalized AUC are presented for both monoclonal antibodies. Dose normalized AUC for AUC0-168 was calculated as AUC(0-168)/Dose.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 and 168 hours post-infusion at Week 1|"The Pharmacokinetics (PK) Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||μg*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2620399|NCT01955473|Secondary|Area Under Concentration-time Curve (AUC) From Start of First Infusion to 168 Hours (AUC0-168h) for the Weekly Regimen at Week 4: Multiple Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here AUC are presented for both monoclonal antibodies. Results were to be assessed for weekly dosing cohorts (Part A: Sym004 6 mg/kg, Part A: Sym004 9/6 mg/kg, Part A: Sym004 12 mg/kg, Part B: Sym004 12 mg/kg) only.|Pre-infusion, end of infusion, 4, 8, 12, 24, and 168 hours post-infusion at Week 4|The PK Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here “Number of Participants Analyzed” =subjects who were evaluable for this outcome and “n” =subjects who were evaluable for specified monoclonal antibody.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2620400|NCT01955473|Secondary|Area Under Concentration-time Curve (AUC) From Start of First Infusion to 168 Hours (AUC0-168h) at Week 1: Single Dose|Sym004 is a mixture of two mouse-human chimeric immunoglobulin G1 anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (called monoclonal antibodies [mAb] 992 and mAb 1024). Here AUC are presented for both monoclonal antibodies.|Pre-infusion, end of infusion, 4, 8, 12, 24, 48 and 168 hours post-infusion at Week 1|The Pharmacokinetics (PK) Analysis Set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004 and who provided sufficient data for a concentration time profile for Sym004. Here “Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome measure.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2620401|NCT01955473|Primary|Number of Subjects With Treatment-emergent Adverse (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation or TEAEs Leading to Death|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. AEs were considered treatment emergent if they started on or after the day of first administration of the Sym004 or if they started prior to administration but worsened after receiving the first dose of treatment.|Baseline up to 4 weeks after the last Sym004 administration, up to a maximum of 41.1 weeks|Safety analysis set consisted of all subjects (from Parts A and B) who received at least 1 administration of Sym004.|||subjects|||Number
2620487|NCT01954394|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percentage of participants|||Number
2620402|NCT01955473|Primary|Number of Subjects With Dose Limiting Toxicities (DLTs) Determined in Part-A|DLT: any of the following National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Grade 4 hematologic or Grade 3/4 non-hematologic toxicities that occurred during DLT observation period of Part A, and were considered by Investigator to be at least possibly related to study treatment, and confirmed by Safety Monitoring Committee. Hematological toxicities: Grade 4 neutropenia, febrile neutropenia, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with bleeding episodes. Nonhematological toxicities: Grade 3 or higher non-hematological toxicity with exception of Grade 3 fatigue/skin toxicity; Grade 3 nausea/vomiting without appropriate prophylactic therapy; Grade 3 diarrhoea recovered within 2 days with adequate treatment or did not accompany fever/dehydration; Grade 3 or 4 laboratory liver parameter abnormalities with duration of less than 3 days.|Week 1 up to Week 4 (Part A)|DLT Analysis Set consisted of all subjects who received at least 3 of 4 weekly administrations (for weekly dosing cohort) or who received 2 biweekly administrations (for biweekly dosing cohort) and experienced a DLT during DLT observation period.|||subjects|||Number
2620403|NCT01955434|Other Pre-specified|Degradation of cIAP1 in PBMC|Continuous biomarker levels will be explored in a graphical manner including mean plots and plots of change and percent change from baseline and other summary measures. Any potential relationships between the baseline level or change in the level of each biomarker and clinical outcome such as confirmed overall response, 6-month progression-free survival, and adverse event incidence will be further analyzed using Wilcoxon rank sum tests or logistic regression methods, as appropriate. Association between a mutation status and confirmed overall response will be assessed using a chi-squared test.|Baseline up to 1 year|||||||
2620404|NCT01955434|Other Pre-specified|Changes in Serum Cytokines|Continuous biomarker levels will be explored in a graphical manner including mean plots and plots of change and percent change from baseline and other summary measures. Any potential relationships between the baseline level or change in the level of each biomarker and clinical outcome such as confirmed overall response, 6-month progression-free survival, and adverse event incidence will be further analyzed using Wilcoxon rank sum tests or logistic regression methods, as appropriate. Association between a mutation status and confirmed overall response will be assessed using a chi-squared test.|Baseline up to 1 year|||||||
2620405|NCT01955434|Other Pre-specified|Changes in Immune Cell Subsets|Continuous biomarker levels will be explored in a graphical manner including mean plots and plots of change and percent change from baseline and other summary measures. Any potential relationships between the baseline level or change in the level of each biomarker and clinical outcome such as confirmed overall response, 6-month progression-free survival, and adverse event incidence will be further analyzed using Wilcoxon rank sum tests or logistic regression methods, as appropriate. Association between a mutation status and confirmed overall response will be assessed using a chi-squared test.|Baseline up to 1 year|||||||
2620406|NCT01955434|Other Pre-specified|Change in Patient-reported Outcomes (Quality of Life and Symptoms)|Scale score trajectories over time will be examined using stream plots and mean plots with standard deviation error bars overall. Changes from baseline at each cycle will be statistically tested using paired t-tests, and standardized response means (mean of the change from baseline scores at a given cycle, divided by the standard deviation of the change scores) will be interpreted (after applying Middel's adjustment) using Cohen's cut-offs. Correlation between outcomes will employ Pearson and/or Spearman correlations at individual time points.|Baseline up to 1 year|||||||
2620407|NCT01955434|Other Pre-specified|Activating Mutations of the NFKB Pathway|Continuous biomarker levels will be explored in a graphical manner including mean plots and plots of change and percent change from baseline and other summary measures. Any potential relationships between the baseline level or change in the level of each biomarker and clinical outcome such as confirmed overall response, 6-month progression-free survival, and adverse event incidence will be further analyzed using Wilcoxon rank sum tests or logistic regression methods, as appropriate. Association between a mutation status and confirmed overall response will be assessed using a chi-squared test.|Up to 1 year|||||||
2620408|NCT01955434|Secondary|Overall Survival|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 1 year||||months||95% Confidence Interval|Median
2620409|NCT01955434|Secondary|Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)|The maximum grade for each type of adverse event, regardless of causality, will be recorded and reported for each patient, and frequency tables will be reviewed to determine adverse event patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event are reported below.|Up to 30 days after the last day of study drug treatment||||percentage of patients|||Number
2620410|NCT01955434|Secondary|Event-free Survival|The event-free survival time is defined as the time from registration to disease progression while receiving LCL161 and cyclophosphamide, death due to any cause, or subsequent treatment for multiple myeloma. Date of progression will be defined as the date that the criteria for progressive disease were first met after initiation of cyclophosphamide. If a patient goes off study treatment and never received cyclophosphamide, they will be censored on the date they went off study treatment. If a patient initiates cyclophosphamide but later discontinues cyclophosphamide due to toxicity and continues LCL161 alone, disease progression on LCL161 alone will be considered an event in this case. The distribution of event-free survival will be estimated using the method of Kaplan-Meier.|From registration to disease progression while receiving SMAC mimetic LCL161 and cyclophosphamide, death due to any cause, or subsequent treatment for multiple myeloma, assessed up to 1 year|Patients treated with combination of LCL161 and cyclophosphamide were included in this analysis.|||months||95% Confidence Interval|Median
2620411|NCT01955434|Secondary|Combination Agent Response Rate|The overall response rate (percentage) with the addition of cyclophosphamide will be estimated by the number of patients who achieve a confirmed overall response at any time (with SMAC mimetic LCL161 plus cyclophosphamide) divided by the number of evaluable patients times 100. 95% confidence intervals for the true confirmed overall response rate will be calculated by the exact binomial method.|Up to 1 year|Patients treated with combination of LCL161 and cyclophosphamide were included in this analysis.|||percentage of patients||95% Confidence Interval|Number
2620412|NCT01955434|Primary|Confirmed Overall Response Rate (Stringent Complete Response [sCR], Complete Response [CR], Very Good Partial Response [VGPR], or Partial Response [PR]) With Single Agent SMAC Mimetic LCL161|The primary endpoint of this study is the confirmed overall response rate with single agent LCL161 (prior to initiation of cyclophosphamide). A confirmed overall response is defined as sCR (CR as defined+Normal FLC ratio+Absence of clonal PCs by immunohistochemistry), CR (Negative immunofixation of serum and urine+Disappearance of any soft tissue plasmacytoma+<5% PCs in Bone Marrow+a normal FLC ratio), VGPR (Serum and urine M-component detectable by immunofixation but not on electrophoresis), or PR (If present at baseline, ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein or to <200 mg/24hrs) noted as the objective status on two consecutive evaluations while receiving single agent LCL161.The rate (percentage) of successes will be estimated by the number of successes divided by the total number of evaluable patients times 100. 95% confidence intervals for the true success percentage will be calculated by the exact binomial method.|Up to 1 year||||percentage of patients||95% Confidence Interval|Number
2620413|NCT01955382|Primary|Safety|To assess the safety of adjunct treatment with oAC; specifically, children were hospitalized while their vital signs were measured, IV site inspected, state of consciousness assessed, and selected symptoms (nausea, vomiting, diarrhea, constipation, abdominal pain, headache, and dizziness) surveyed at 0, 2, 4, 6, 8, and 12 hours, and then every 6 hours until 48 hours or until parasitemia became undetectable (one negative thick blood film), whichever was later.|During patient treatment up to 48 hours|Children who received treatment per protocol|||Participants|||Count of Participants
2620414|NCT01955382|Primary|Parasite Clearance Half-life|To compare parasite clearance half-life in patients treated with IV AS + oAC or IV AS alone; parasite clearance half-life is the time it takes for the parasite density to decrease by half, and can be assessed by analysing frequent parasite density counts at 0, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, and 48 hours after initiating treatment.|During patient treatment||||Hours||Standard Deviation|Mean
2620415|NCT01955369|Other Pre-specified|Gastrostomy|gastrostomy of ALS patients following weight loss and/or swallowing problems with aspiration|an average of 3 years||||participants|||Number
2620416|NCT01955369|Secondary|Tracheostomy|tracheostomy in ALS patients following respiratory failure|an average of 3 years||||participants|||Number
2620417|NCT01955369|Primary|Death|death of participating ALS patients independent of the cause of death|an average of 3 years||||participants|||Number
2620418|NCT01955161|Secondary|Change in Health-related Quality of Life (EQ-5D VAS)|"Change from baseline to Week 24 in EQ-5D Visual Analogue Scale (EQ-5D VAS).~The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state)."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2620419|NCT01955161|Secondary|Change in Health-related Quality of Life (EQ-5D) Utility Score|"Change from baseline to Week 24 in EuroQol 5-dimensional (EQ-5D) utility score~The EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). Each descriptive item is rated on a 3-point index ranging from 1 (no problems) to 3 (extreme problems) that is used for calculating a single summary index (from 0 to 1). A higher EQ-5D score indicates a worse outcome."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2620420|NCT01955161|Secondary|Change in Cognitive Aspects of Mental Function|Change from baseline to Week 24 in Mini Mental State Examination (MMSE). The Mini Mental State Examination (MMSE) is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2620421|NCT01955161|Secondary|Clinical Worsening|Clinical worsening at Week 24 (Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog above or equal to 4, change in ADCS-ADL23 below 0, and ADCS-CGIC above 4])|Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||Participants|||Count of Participants
2620422|NCT01955161|Secondary|Clinical Improvement|Clinical response at Week 24 (based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes [change in ADAS-cog below or equal to -4, change in ADCS-ADL23 at least 0, and ADCS-CGIC below or equal to 4])|Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||Participants|||Count of Participants
2620510|NCT01954264|Secondary|Number of Subjects With Other Medical History Characteristics, Overall|The medical history characteristics were as follows: -subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated Bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS).|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Participants|||Count of Participants
2620423|NCT01955161|Secondary|Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline|"Change from baseline to Week 24 in NPI anxiety item score in patients with an NPI anxiety item score of at least 2 at baseline~The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total score for the NPI anxiety item ranges from 0-12 (frequency multiplied by severity), where a higher score represents a worse outcome."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome/item measure assessed|||units on a scale||Standard Error|Least Squares Mean
2620424|NCT01955161|Secondary|Change in Individual Behavioural Disturbance Items|"Change in single NPI item scores at Week 24.~The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). Total score for each single NPI item ranges from 0-12 (frequency multiplied by severity), where higher scores represent worse outcome."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure/item assessed|||units on a scale||Standard Error|Least Squares Mean
2620425|NCT01955161|Secondary|Change in Behavioural Disturbance|"Change from baseline to Week 24 in Neuropsychiatric Inventory (NPI) total score.~The Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is rated for frequency (a 4-point scale from 1 [occasionally] to 4 [very frequent]) and severity (a 3-point scale from 1 [mild] to 3 [marked]). The total NPI score is the frequency ratings multiplied by the severity ratings and ranges from 0 to 144 (higher score indicates worse outcome)."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2620426|NCT01955161|Secondary|Change in Global Impression|"Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 24.~The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change is a semi-structured interview to assess clinically relevant changes in patients with AD. The items determine cognition, behavior, social and daily functioning. Severity at baseline is rated on a 7-point scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). The clinically relevant change from baseline is rated on a 7-point scale from 1 (marked improvement) to 7 (marked worsening)."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2620427|NCT01955161|Secondary|Change in Daily Functioning|"Change from baseline to Week 24 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score.~The Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) is a 23-item clinician-rated inventory to assess activities of daily living (conducted with a caregiver or informant). Each item comprises a series of hierarchical sub-questions, ranging from the highest level of independent performance to a complete loss for each activity. Total score of the 23 items ranges from 0 to 78 (higher score indicates lower disability)."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2620428|NCT01955161|Primary|Change in Cognition|"Change from baseline to Week 24 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score.~The Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog) is a 11-item neuropsychological test that assess the severity of cognitive impairment. The items determine the patient's orientation, memory, language, and praxis. Total score of the 11 items range from 0 to 70 (lower score indicates lower cognitive impairment)."|Baseline to Week 24|All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.|||units on a scale||Standard Error|Least Squares Mean
2620429|NCT01955122|Secondary|Patient Satisfaction|"Follow up phone call was done 24 hours post procedure. Patients were asked the following : On a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as you can imagine, how would you describe your colonoscopy experience? 0 1 2 3 4 5 6 7 8 9 10"|24 hours post procedure|Data was not analyzed since the patients satisfactory score was general estimation which could not be associated with either the standard colonoscopy or the EndoRings colonoscopy, therefore the intended endpoint failed.||||||
2620430|NCT01955122|Secondary|Colon Area Screened|Subjective evaluation of the additional area screened by the physician.|During the procedure|Evaluation of the additional area screened by the physician was not collected from any participant during the study||||||
2620431|NCT01955122|Secondary|Scope Centering Ability|Ability to center the scope inside the gastrointestinal tract.|During the procedure|Centering ability was not collected from any procedure during the study||||||
2620433|NCT01955122|Secondary|Procedure Time A Stopwatch Will be Used for Stopping the Timing of the Procedure for Any Polypectomy Performed and Then Restarting Once the Polypectomy is Completed, Meaning That Purely Procedure Time is Measured|The following will be recorded: a. Time for intubation to the cecum. b. Time for withdrawal from the cecum to the anal verge. c. Total procedure time A stopwatch will be used for stopping the timing of the procedure for any polypectomy performed and then restarting once the polypectomy is completed, meaning that purely procedure time is measured|During the procedure||||minutes||Standard Deviation|Mean
2620434|NCT01955122|Secondary|Total Number of Therapeutic Interventions Performed|Ability to perform therapeutic interventions, such as biopsies, polypectomies, APC etc. during the Standard Colonoscopy and during the EndoRings Colonoscopy. The number of interventions was not compared, this was just a safety outcome meant to prove there was no difficulty in performing interventions in both arms.|Interventions during procedure||||Total Interventions performed|||Number
2620435|NCT01955122|Primary|Adenoma and Polyp Miss Rate|"Group A- we measured the Adenoma&Polyp miss rates in the first procedure with Standard (based on what we discovered on the second procedure with the EndoRings).~Group B- we measured the Adenoma&Polyp miss rates in the first procedure with EndoRings (based on what we discovered on the second procedure with the Standard).~Adenoma/Polyp Miss Rate means: total number of adenomas or polyps detected during the second procedure per Group divided by the total number of adenomas/polyps detected overall per Group]*100"|30min for Standard colonoscopy and 30min for EndoRings colonoscopy- 1 hour in total.||||percentage of :Adenomas/Polyp missed||95% Confidence Interval|Number
2620436|NCT01955083|Post-Hoc|Percentage of Good Response After MIS|Postoperative 'VAS <=3' was traditionally defined as 'major response'. For a comprehensive profile of the outcomes, we further created another definition of 'fine response': 'postoperative VAS <=5 plus SOS >=60' post hoc in the present study. Accordingly, patients with a postoperative VAS <=3 or postoperative VAS <=5 plus SOS >=60' group was considered to have a 'good response'. Therefore, we calculated the 'good response' rate in the radiofrequency and pillar implant groups.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of Good Response||Standard Error|Mean
2620437|NCT01955083|Secondary|Percent Change in B1-Fmean After MIS|Percent change ([after value-before value]/[before value]*100) in B1-Fmean (Hz) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of B1-Fmean||Standard Error|Mean
2620438|NCT01955083|Secondary|Percent Change in B1-Fpeak After MIS|Percent change ([after value-before value]/[before value]*100) in B1-Fpeak (Hz) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of B1-Fpeak||Standard Error|Mean
2620439|NCT01955083|Secondary|Percent Change in B1-Imean After MIS|Percent change ([after value-before value]/[before value]*100) in B1-Imean (dB) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of B1-Imean||Standard Error|Mean
2620440|NCT01955083|Secondary|Percent Change in B1-Imax After MIS|Percent change ([after value-before value]/[before value]*100) in B1-Imax (dB) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of B1-Imax||Standard Error|Mean
2620441|NCT01955083|Secondary|Percent Change in B1-SI After MIS|Percent change ([after value-before value]/[before value]*100) in B1-SI (event/hour) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of B1-SI||Standard Error|Mean
2620442|NCT01955083|Secondary|Percent Change in Total-Fmean After MIS|Percent change ([after value-before value]/[before value]*100) in Total-Fmean (Hz) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of Total-Fmean||Standard Error|Mean
2620443|NCT01955083|Secondary|Percent Change in Total-Fpeak After MIS|Percent change ([after value-before value]/[before value]*100) in Total-Fpeak (Hz) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of Total-Fpeak||Standard Error|Mean
2620444|NCT01955083|Secondary|Percent Change in Total-Imean After MIS|Percent change ([after value-before value]/[before value]*100) in Total-Imean (dB) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of Total-Imean||Standard Error|Mean
2620445|NCT01955083|Secondary|Percent Change in Total-Imax After MIS|Percent change ([after value-before value]/[before value]*100) in Total-Imax (dB) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of Total-Imax||Standard Error|Mean
2620446|NCT01955083|Secondary|Percent Change in Total-SI After MIS|Percent change ([after value-before value]/[before value]*100) in Total-SI (event/hour) before and at 3 months after surgery was calculated.|baseline and 3 months following surgery|A total of 28 participants completed the follow-up protocol and two participants dropped out after surgery.|||percentage of Total-SI||Standard Error|Mean
2620447|NCT01955083|Secondary|Change in SOS Score After MIS|Change in SOS score at 3 months after radiofrequency or pillar implant were calculated.|baseline and 3 months following surgery|Twenty-eight participants completed the follow-up protocol and two participants dropped out after surgery.|||units on a scale||95% Confidence Interval|Mean
2620448|NCT01955083|Primary|Change in VAS Score After MIS|The mean change in subjective snoring severity (VAS) at 3 months after MIS was the primary outcome measurement.|baseline and 3 months following surgery|Twenty-eight patients completed the protocol; two study cases were not available for follow-up. Fourteen patients underwent radiofrequency surgery and 14 patients received pillar implant surgery. Accordingly, we analyzed the participants who completed the study protocol.|||units on a scale||95% Confidence Interval|Mean
2620453|NCT01955005|Secondary|Proportion of Participants Who Received One or More Duplicate Laboratory Tests in the Non-VA Provider Visit.|Therapeutic duplication will be defined as concurrent use of more than one medication from the same therapeutic class. For laboratory duplication, we will review non-VA and VA medical records 6 months prior to the non-VA provider visit. Each patient will be assigned a dichotomous indicator for whether they received therapeutic duplication and/or laboratory duplication during their non-VA provider visit|Typically within 1 month of non-VA provider visit|Some veterans had their laboratories drawn prior to the medical visit and were therefore excluded from this analysis.|||proportion of participants|||Number
2620454|NCT01955005|Secondary|Proportion of Total Number of Unique Medications Discrepant Between VA and Non-VA Medication Lists|A medication discrepancy metric was be calculated by comparing the current VA medication list with the non-VA provider medication list to determine the total number of distinct medications. The number of discrepant medications between these lists is the numerator and is divided by the total number of distinct medications on both lists combined. This will yield a range of scores between score between 0 and 1, with 1 indicating perfect agreement between the two lists.|Typically within 1 month of non-VA provider visit|Medication reconciliation was based on Medical Record Review, therefore there was better representation of the entire sample. 2 Veterans were not included in the Internet Skills Training group because the medical records sent from the Non-VA provider were not adequate to determine an accurate medication list.|||proportion of medications discrepant||Standard Deviation|Mean
2620455|NCT01955005|Primary|Percentage of Participants Who Brought Their VA Information From My HealtheVet to Their Visit With Their Non-VA Provider|The primary outcome is whether or not the veteran brings their VA information from My HealtheVet to their visit with their non-VA provider. Providers will be asked to complete a form during the appointment where assessment of sharing this information is embedded in a checklist of possible visit activities. Participants will also if they provided this information to the provider in the event the provider opts to not return the form.|Within 1-2 week of non-VA provider visit|This outcome was collected from the provider completed questionnaire. The reduced sample size is due to the response rate for the My Healthe Vet training group providers (74%) and the Internet Skills Training group (52%).|||Percentage of Participants|||Number
2620456|NCT01954927|Other Pre-specified|Absolute Change in Pain, Study Drug to Hospital Discharge Decision|To compare the change in pain score from time of administration of study drug to the point of decision for either admission or discharge to home, in the gabapentin and placebo groups. (0=no pain and 10=worst possible pain)|From time of presentation to the acute care setting until time of either discharge to home or admission to the hospital, up to 8 hours.|Patients with Sickle cell disease (any genotype) ages ≥1 year and <21 years seeking care for acute vaso-occlusive pain at St Jude Children's Hospital. Placebo arm: 6 subjects missed pain assessments at treatment. Gabapentin arm: 7 subjects missed pain assessment at treatment; 2 of the 7 missed the assessment at hospital discharge decision.|||score on a scale||Inter-Quartile Range|Median
2620457|NCT01954927|Other Pre-specified|Absolute Change in Pain From Study Drug to 3 Hours Post Administration of Study Drug|To compare the change in pain score from time of administration of study drug to assessment at 3 hours post administration of study drug in the gabapentin vs. placebo groups. (0=no pain and 10=worst possible pain)|Study drug administration to 3-hours post study drug administration|Patients with Sickle cell disease (any genotype) ages ≥1 year and <21 years seeking care for acute vaso-occlusive pain at St Jude Children’s Hospital. Placebo arm: 6 subjects missed pain assessments at treatment; 2 missed pain assessment at 3h. Gabapentin arm: 7 missed pain assessment at treatment; 2 of the 7 also missed the assessment at 3h.|||score on a scale||Inter-Quartile Range|Median
2620458|NCT01954927|Other Pre-specified|Hospital Admission|To compare the rate of admission related to pain management, in the gabapentin vs. placebo groups. (Outcome: binary response - admitted or discharged)|From time of presentation to the acute care setting until time of either discharge to home or admission to the hospital, up to 8 hours.|Patients with Sickle cell disease (any genotype) ages ≥1 year and <21 years seeking care for acute vaso-occlusive pain at St Jude Children’s Hospital.|||Participants|||Count of Participants
2620459|NCT01954927|Other Pre-specified|Morphine Equivalent Doses Administered From Presentation to the Point of Decision for Either Admission or Discharge to Home|To compare the total morphine equivalent dose (mg/kg) used to control pain during VOC between presentation to the acute care setting and the point of decision for either admission or discharge to home, in the gabapentin and placebo groups.|From time of presentation to the acute care setting until time of either discharge to home or admission to the hospital, up to 8 hours.|Patients with Sickle cell disease (any genotype) ages ≥1 year and <21 years seeking care for acute vaso-occlusive pain at St Jude Children’s Hospital.|||mg/kg||Inter-Quartile Range|Median
2620460|NCT01954927|Other Pre-specified|Number of Participants With Successful Pain Interventions by Arm Between Presentation and Point of Decision for Either Hospital Admission or Discharge to Home|For each patient, if the reduction of the pain scores (0=no pain and 10=worst possible pain) between presentation to the acute care setting and Point of decision for either hospital admission or discharge to home is 33% or greater, then this patient will be defined as having a successful intervention.|From time of presentation to the acute care setting until time of either discharge to home or admission to the hospital, up to 8 hours.|Patients with Sickle cell disease (any genotype) ages ≥1 year and <21 years seeking care for acute vaso-occlusive pain at St Jude Children’s Hospital. There were 2 subjects in the Gabapentin group that did not have a pain assessment admit/discharge decision. N=84 patients had assessments at both presentation and admit/discharge.|||Participants|||Count of Participants
2620461|NCT01954927|Secondary|Morphine Equivalent Doses Administered From Presentation to 3-hours Post Treatment With Gabapentin/Placebo|The equivalent dose of morphine in mg|The 3-hour pain assessment was the pain assessment closest in time to the 3-hour time and was typically within 30 minutes of target. The time period was extended for 12 patients that were sleeping.|Patients with Sickle cell disease (any genotype) ages ≥1 year and <21 years seeking care for acute vaso-occlusive pain at St Jude Children’s Hospital.|||mg/kg||Inter-Quartile Range|Median
2620561|NCT01954160|Primary|Urine Sodium Excretion|Within-subject comparison of increase in urine sodium excretion following saline loading before RSD and 13 weeks following RSD.|13 Weeks following Renal Denervation|Study terminated early, data not collected, endpoints not measured||||||
2620462|NCT01954927|Primary|Number of Participants With Successful Pain Interventions by Arm Between Presentation and 3 Hours Post Administration of Study Drug|Pain scales used are the numerical rating system, the Faces Pain Scale, and the Faces, Legs, Arms, Cry and Consolability (FLACC) pain scale (for patients 7 years or older, ages 4-6 years, or less than 4 years, respectively). For each patient, if the reduction of the pain scores (0=no pain and 10=worst possible pain) between presentation to the acute care setting and 3 hours post administration of study drug is 33% or greater, then this patient will be defined as having a successful intervention. The proportions of successful interventions in the gabapentin and placebo groups will be estimated and compared using Z-test.|Baseline and 3 hours (±30 minutes) post administration of study drug. The 3-hour pain assessment time-period was extended for subjects that were sleep until the first available measurement.|Patients with Sickle cell disease (any genotype) ages ≥1 year and <21 years seeking care for acute vaso-occlusive pain at St Jude Children’s Hospital. A total of 4 subjects were missing the pain assessment at 3 hours (2 in each arm). The resulting sample sizes were n=40 (Gabapentin arm) and n=42 (placebo arm), for a total sample size of n=82.|||Participants|||Count of Participants
2620463|NCT01954771|Secondary|HbA1c(%) at Endpoint||12 weeks|13 patients did not followed the study protocol.|||percentage||Inter-Quartile Range|Median
2620464|NCT01954771|Secondary|Number of Participants With Severe Hypoglycemia (≤50 mg/dL or 2.8mmol/L),Captured by SMBG Method and CGMS|Severe hypoglycemia is defined as glucose concentration of ≤2.8mmol/L (50 mg/dL).|12 weeks|13 patients did not followed the study protocol.|||participants|||Number
2620465|NCT01954771|Secondary|The Correlation Study Between HbA1c and Glycemic Profiles of MBG (Mean Blood Glucose) From SMBG Protocols and CGMS|A correlation coefficient of 0.5 is defined as large effect size.(Cohen Jacob.Statistical power analysis for the the behavioral sciences.2nd edition.Lawrence Erlbaum Associates.1988:80)|12 weeks|13 patients did not followed the study protocol.|||mmol/L||Inter-Quartile Range|Median
2620466|NCT01954771|Primary|Evaluation of Peak and Nadir Glucose Profiles From Continuous Glucose Monitoring System (CGMS)|The peak value:＞16.7mmol/L(which may precipitate ketosis),nadir:≤2.8mmol/L(Severe hypoglycemia).|12 weeks|13 patients did not followed the study protocol.|||mmol/L||Inter-Quartile Range|Median
2620467|NCT01954745|Secondary|Median Overall Survival (OS)|To evaluate the median overall survival (OS) for patients with advanced cholangiocarcinoma receiving cabozantinib|2 years|Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles|||months||95% Confidence Interval|Median
2620468|NCT01954745|Secondary|Objective Response Rate (ORR)|To evaluate the objective response rate (ORR) for patients with advanced cholangiocarcinoma receiving cabozantinib|2 Years|Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles|||percent|||Number
2620469|NCT01954745|Secondary|Number of Patients With Adverse Events|Evaluate the number of patients with advanced cholangiocarcinoma being treated with cabozantinib who have adverse events during treatment|2 Years|Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles|||participants|||Number
2620470|NCT01954745|Primary|Median Progression Free Survival (PFS)|To evaluate the median progression free survival (PFS) of cabozantinib in patients with advanced cholangiocarcinoma after progression on 1 or 2 prior systemic therapies.|2 Years|Patients treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles|||months||95% Confidence Interval|Median
2620471|NCT01954628|Secondary|AQX-1125 Concentrations in Plasma (Trough Values)|The secondary objectives are to evaluate the pharmacokinetics (PK) of AQX-1125 in plasma.|12 weeks|PK Population|||micrograms per Liter||Geometric Coefficient of Variation|Geometric Mean
2620472|NCT01954628|Secondary|Change From Baseline in FEV1|"The secondary objective is to evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on forced expiratory volume in 1 second [FEV1].~FEV1 was determined from post-bronchodilator spirometry testing done at clinic visits."|12 weeks|Full analysis set. Missing post-treatment data imputed using the last observation carried forward principle.|||Liter||95% Confidence Interval|Least Squares Mean
2620473|NCT01954628|Secondary|The Number of Subjects With at Least One COPD Exacerbation.|The number of subjects that presented with a COPD exacerbation during the 12 week treatment period.|12 weeks|Full analysis set.|||participants|||Number
2620474|NCT01954628|Secondary|Time to First COPD Exacerbation|The secondary objective is to evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on the time to first exacerbation requiring medical intervention of oral corticosteroids and/or antibiotics.|12 weeks|Full analysis set|||day(s)||Standard Deviation|Mean
2620475|NCT01954628|Secondary|Analysis of the Number of COPD Exacerbations (Medically Treated Event (MTE))|"The secondary objective is to evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on the number of COPD exacerbations (MTE).~COPD exacerbations were referred to as Medically Treated Exacerbations (MTEs) and identified as a change in symptoms and/or signs of COPD requiring prescription of one or both of: (1) Course of oral corticosteroids or (2) Antibiotic(s)."|12 weeks|Full analysis set was used and analyzed using the negative binomial regression model with fixed factors treatment, region and time in study as offset. Adjusted means for treatment group shows number of exacerbations/year.|||Number of exacerbations/year||95% Confidence Interval|Least Squares Mean
2620476|NCT01954628|Secondary|Change From Baseline in COPD Assessment Tool (CAT) Score|The secondary objective is to evaluate the treatment effect of once daily administrations of AQX-1125 compared to placebo over 12 weeks on the COPD Assessment Tool (CAT) score.The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. A negative change from baseline indicates improvement. The change in total CAT score from Day 1, before taking study drug (baseline), to end of the 12 week treatment period was compared between the two treatments using an ANOVA model adjusting for treatment and region and including the baseline score as a covariate.|12 weeks|Full analysis set. Missing post-treatment data imputed using the last observation carried forward principle.|||COPD Assessment Tool Score||95% Confidence Interval|Least Squares Mean
2620650|NCT01953874|Secondary|Biomarkers - Cardiovascular|Biomarkers of cardiovascular function reported as hs-CRP|Change from Baseline to 6 months|Not all participants had biomarker samples that were able to be analyzed. For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||mg/L||Standard Deviation|Mean
2620477|NCT01954628|Primary|The Primary Efficacy Variable Was the AAC for Daily EXACT Scores During the 12-week Treatment Period.|The primary variable (endpoint) of this study is the difference in the Area Above the Curve (AAC) for the daily EXACT score from baseline to Week 12 between subjects treated with AQX-1125 and placebo.The EXACT questionnaire is a patient reported outcome (PRO) measure designed to standardise the method for evaluating the frequency, severity and duration of acute exacerbations of COPD. The EXACT is a 14-item daily questionnaire where each item is assessed on a 5 or 6 point ordinal scale. Participants completed the EXACT questionnaire on a daily basis via an electronic diary from Day 1 (pre-dose) to Day 84 (week 12). Higher scores on the daily EXACT questionnaire indicate a more severe health state. When the post-treatment EXACT scores are lower (i.e. improved symptoms) than baseline EXACT, the AACs are positive.|12 weeks|Full Analysis Set (FAS). The FAS was all randomized subjects who have received at least one dose of the study drug and had at least one efficacy assessment (valid diary entries) post-baseline. Imputation, the mean of the last 5 days, counted backwards from day of last recording, in the treatment period will be used.|||Area Above Curve on Daily Exact Score||95% Confidence Interval|Least Squares Mean
2620478|NCT01954394|Secondary|Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 48, 96, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||ratio||Standard Deviation|Mean
2620479|NCT01954394|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 48, 96, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percent change||Standard Deviation|Mean
2620480|NCT01954394|Secondary|Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 48, 96, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percent change||Standard Deviation|Mean
2620481|NCT01954394|Secondary|Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 48, 96, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percent change||Standard Deviation|Mean
2620482|NCT01954394|Secondary|Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percent change||Standard Deviation|Mean
2620483|NCT01954394|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percent change||Standard Deviation|Mean
2620484|NCT01954394|Secondary|Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percent change||Standard Deviation|Mean
2620485|NCT01954394|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percent change||Standard Deviation|Mean
2620486|NCT01954394|Secondary|Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percentage of participants|||Number
2620651|NCT01953874|Secondary|Biomarkers - Inflammation|Biomarkers of inflammation reported as troponin I ultra-sensitive|Change from Baseline to 6 months|Not all participants had biomarker samples that were able to be analyzed. For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||ng/mL||Standard Deviation|Mean
2620488|NCT01954394|Secondary|Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percentage of participants|||Number
2620489|NCT01954394|Secondary|Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||mmol/L||Standard Deviation|Mean
2620490|NCT01954394|Secondary|Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|mITT population. Here, “Number analyzed” signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||mg/dL||Standard Deviation|Mean
2620491|NCT01954394|Secondary|Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168|Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.|Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168|Modified ITT (mITT) population: all enrolled and treated participants with 1 baseline (from parent study) and at least 1 post-baseline calculated LDL-C value on-treatment. “Number analyzed” = participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.|||percent change||Standard Deviation|Mean
2620492|NCT01954394|Primary|Percentage of Participants Who Experienced Adverse Events (AEs)|Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study +70 days). Clinically significant lab and vital sign abnormalities were to be reported as AEs.|Up to 10 weeks after last study drug administration (maximum of 176 weeks)|All enrolled participants who received at least one dose or part of a dose of alirocumab in this study.|||percentage of participants|||Number
2620493|NCT01954264|Secondary|Number of Subjects With Different P. Falciparum Parasite Densities, by House Information and Center|The malaria prevention and risk factor characteristics for this endpoint were the following: - Main house construction material (MHCM) walls, floor, roof, windows/eaves, nets; - Main source of drinking water (MSDW); - Presence of electricity (PE). Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. Closed water source = pipe water, tube well, dug well, protected well; Open water source = unprotected well, spring water, rainwater, tanker truck, surface water. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Participants|||Count of Participants
2620494|NCT01954264|Secondary|Number of Subjects With P. Falciparum by House Construction Material and Other House Information, Overall|The malaria prevention and risk factor characteristics for this endpoint were the following: - Main house construction material (MHCM) walls, floor, roof, windows/eaves, nets; - Main source of drinking water (MSDW); - Presence of electricity (PE). Note: *Natural floor = earth, sand, dung; Rudimentary floor = wood planks, palm, bamboo. % Closed water source (piper water, tube well, dug well, protected well); Open water source (unprotected well, spring water, rainwater, tanker truck, surface water).|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Participants|||Count of Participants
2620495|NCT01954264|Secondary|Number of Subjects With Different P. Falciparum Densities by Situation Area and Center|The malaria prevention and risk factor characteristics were the following: Situation area (urban, rural, semi-rural) and Type of Location*. Note: *Large city = >1 million habitants; Small city = >50000 & < 1 million habitants ; Town = > 10000 and < 50000 habitants; Countryside = < 10000 habitants. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Participants|||Count of Participants
2620496|NCT01954264|Secondary|Number of Subjects With P. Falciparum by Situation Area, Overall|The malaria prevention and risk factor characteristics for this endpoint were the following: Situation area (rural, urban, semi-rural) and Type of Location*. Note: *Large city = >1 million habitants; Small city = >50000 & < 1 million habitants ; Town = > 10000 and < 50000 habitants; Countryside = < 10000 habitants.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Participants|||Count of Participants
2620497|NCT01954264|Secondary|Descriptive Statistics for Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center|The malaria prevention and risk factor for this endpoint was: Number of subjects living in the same part of the house (PLSPH). Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Persons Living in Same Part of House||Standard Deviation|Mean
2624506|NCT01923480|Secondary|Plasma Concentration of Isoleucine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
2620498|NCT01954264|Secondary|Number of Subjects With Different P. Falciparum Parasite Densities, Living in the Same House, by Center|The malaria prevention and risk factor for this endpoint was: Number of subjects living in the same part of the house - persons enrolled in the study (PLSPH-PES), in the following combinations: < y/x, where x are persons enrolled in the study among less than y persons living in the same part of the house, y-z/x, where x are persons enrolled in the study among y to z persons living in the same part of the house, > z/x, where x persons are enrolled in the study among more than z persons living in the same part of the house, y-z/> x, where more than x persons enrolled in the study among y to z persons living in the same part of the house, > z/> x, where more than x persons enrolled in the study among more than z persons living in the same part of the house. Results are presented for the Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE) and Naikhar (Dakar area)-Senegal (DA-2-SE) centers.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Participants|||Count of Participants
2620499|NCT01954264|Secondary|Descriptive Statistics for Number of Persons With P. Falciparum Living in the Same Part of the House of Persons Enrolled in the Study (PLSPH-PES), Overall|The malaria prevention and risk factor presented in this endpoint was: Number of persons living in the same part of the house (PLSPH).|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Persons Living in Same Part of House||Standard Deviation|Mean
2620500|NCT01954264|Secondary|Number of Persons With P. Falciparum Living in the Same Part of the House of Persons Enrolled in the Study (PLSPH-PES), Overall|The malaria prevention and risk factor presented in this endpoint was: Number of persons living in the same part of the house - persons enrolled in the study (PLSPH-PES), in the following combinations: < y/x, where x are persons enrolled in the study among less than y persons living in the same part of the house, y-z/x, where x are persons enrolled in the study among y to z persons living in the same part of the house, > z/x, where x persons are enrolled in the study among more than z persons living in the same part of the house, y-z/> x, where more than x persons enrolled in the study among y to z persons living in the same part of the house, > z/> x, where more than x persons enrolled in the study among more than z persons living in the same part of the house.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Participants|||Count of Participants
2620501|NCT01954264|Secondary|Days With Fever, Overall|This endpoint presents results per total centers and across all age categories.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Days||Standard Deviation|Mean
2620502|NCT01954264|Secondary|Number of Subjects With Fever, Overall|Characteristics of fever were the following: Fever in the last 24 hours (F 24h) and Fever* at visit (F* at V). Note: *Fever set to Yes if temperature recorded at visit after axillary conversion was ≥ 37.5 ◦C.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Participants|||Count of Participants
2620503|NCT01954264|Secondary|Days of Malaria Treatment, Overall|This endpoint presents results per total centers and across all age categories.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Days||Standard Deviation|Mean
2620504|NCT01954264|Secondary|Number of Days With Therapy, Overall|The duration of anti-malarial therapy referred to the exact number of days of malaria treatment (EDMT) and the number of days of other medication (DOM). Note: * In case of several medication (malaria treatment or other medication) taken per subject, the maximum duration was computed for this study.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Days|||Number
2620505|NCT01954264|Secondary|Number of Subjects With Anti-malarial Therapy, Overall|Anti-malarial therapy included Malaria treatment (MT) in past 14 days, Other medication (OM) in past 14 days and Malaria hospitalization (MH) in the last 3 months.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Participants|||Count of Participants
2620506|NCT01954264|Secondary|Number of Subjects With Plasmodium Species Other Than P. Falciparum, by JTEG Age Group and Per Total Centers|Other Plasmodium species included: P. Malariae, P. Vivax, P. Ovale with Negative and Positive results. A subjects was defined as infected by a specified parasitemia if at least two of the subject`s blood slide readings were positive for the corresponding parasitemia. The results were tabulated according to JTEG age categorisation.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Participants|||Count of Participants
2620507|NCT01954264|Secondary|Number of Subjects by Gender, According to P. Falciparum Infection Status|The gender characteristics were summarized by P. falciparum infection status.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Participants|||Count of Participants
2620508|NCT01954264|Secondary|Number of Subjects by JTEG Age Group, According to P. Falciparum Infection Status|The JTEG categorisation referred to the distribution of subjects by different age groups: 6 months to 4 years of age inclusive (0.5Y-4Y category) and 5 to 9 years of age inclusive (5-9Y category), tabulated according to P. falciparum infection status.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Participants|||Count of Participants
2620509|NCT01954264|Secondary|Number of Subjects by Age, According to P. Falciparum Infection Status|The annual age extended over a 0 year-9 years range. The age characteristics were summarized by P. falciparum infection status.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Participants|||Count of Participants
2620511|NCT01954264|Primary|Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Niakhar Center in Dakar Area in Senegal|MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only one category available for 'Exact number of days of malaria treatment':1-3 days and 'How many holes of that size': ≥5. Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Unadjusted Odds Ratio||95% Confidence Interval|Number
2620512|NCT01954264|Primary|Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Keur Soce Center in Dakar Area in Senegal|MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only one category available for 'Exact number of days of malaria treatment':1-3 days, 'Use of Indoor residual spray - numbers of months ago': 9, 'Use of Commercial Repellents over 7 days': Missing/No - There were not enough values in the reference category ('<5') to compute the OR for HS. Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), UMc > 7D, UIs >7D, UCR > 7D, UTR > 7D, Una >7D.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Unadjusted Odds Ratio||95% Confidence Interval|Number
2620513|NCT01954264|Primary|Odds Ratio for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Ouagadougu Center in Burkina Faso|MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only the reference category for 'Use of Insecticide spray over 7 days': Missing/No and 'Use of Traditional Repellents over 7 days': Missing/No - The reference category ('2') for 'Use of indoor residual spray - number of month ago': 2 Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Unadjusted Odds Ratio||95% Confidence Interval|Number
2620514|NCT01954264|Primary|Odds Ratio (OR) for the Number of Subjects With MCI, Infected With P. Falciparum Parasitemia, for the Nouna Center in Burkina Faso|MCI = measurement of residual spraying, mosquito net usage, SMC, IPTi and ACT - therapy received within the last 14 days as indicator of MTI according to P. falciparum infection status. Note: - There was only the reference category available for 'Use of Traditional Repellents over 7 days': Missing/No - There was only one category available for 'Use of indoor residual spray - number of month ago': 2 Characteristics were as follows: Malaria treatment in past 14 days (Mt past 14D), Numbers of days of malaria treatment (NdMt), Other medication in the past 14 days (Om past 14D), Number of days of other medication (Ndom), Was the subject hospitalized in the last 3 months due to Malaria (Wsh3MM), Subject sleep under a mosquito net night before visit (Ssumnnbv), New net - less than 1 year (Nn < 1Y), Impregnated bednet (Ib), Pierced/torn bednet (P/tb), How many holes of that size (HS), UMc > 7D, UIs > 7D, UCR > 7D, UTR > 7D, Una >7D, Uirs past 12M.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Unadjusted Odds Ratio||95% Confidence Interval|Number
2620515|NCT01954264|Primary|Number of Subjects Infected With P.Falciparum Parasitemia Receiving Malaria Control Interventions (MCIs), by Infection Status|MCI = measurement of residual spraying, mosquito net usage, seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi) and Artemisinin-based combination therapy (ACT) - therapy received within the last 14 days as indicator of malaria transmission intensity (MTI) by center and JTEG according to P. Falciparum infection status. Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). Results presented for overall centers by the following characteristics: Use of Mosquito colis over 7 days (UMc > 7D), Use of Insecticide spray over 7 days (UIs > 7D), Use of Commercial Repellents over 7 days (UCR > 7D), Use of Traditional Repellents over 7 days (UTR > 7D), Use of none of above over 7 days (Una >7D), Use of indoor residual spray in past 12 months to spray interior walls (Uirs past 12M), Use of indoor residual spray - number of months ago (Uirs-nM)|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Participants|||Count of Participants
2620526|NCT01954251|Secondary|Geometric Mean Ratio for Flu HI Antibodies Post-vaccination Titer|The geometric mean ratio for Flu HI antibodies against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts/2/2012 Yamagata was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer.|At Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.|||Ratio||95% Confidence Interval|Geometric Mean
2620516|NCT01954264|Primary|Number of Subjects With Malaria Control Interventions (MCIs), Overall|MCI = measurement of residual spraying, mosquito net usage, seasonal malaria chemoprevention (SMC), intermittent preventative treatment in infants (IPTi) and Artemisinin-based combination therapy (ACT) - therapy received within the last 14 days as indicator of malaria transmission intensity (MTI) by center and JTEG according to P. Falciparum infection status. Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). Results presented for overall centers by the following characteristics: Use of Mosquito colis over 7 days (UMc > 7D), Use of Insecticide spray over 7 days (UIs > 7D), Use of Commercial Repellents over 7 days (UCR > 7D), Use of Traditional Repellents over 7 days (UTR > 7D), Use of none of above over 7 days (Una >7D), Use of indoor residual spray in past 12 months to spray interior walls (Uirs past 12M), Use of indoor residual spray - number of months ago (Uirs-nM)|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Participants|||Count of Participants
2620517|NCT01954264|Primary|Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), by Study Center|PFP = measurement of parasite prevalence (PP) by center according to joint technical expert group (JTEG). Centers: Nouna-Burkina Faso (NOU-BF), Ouagadougou-Burkina Faso (OUA-BF), Keur Soce [Dakar area)-Senegal (DA-1-SE), Naikhar (Dakar area)-Senegal (DA-2-SE). A subject was defined as infected by P. falciparum parasitemia, if at least two of the subject`s blood slide readings were positive for the corresponding parasitemia.|At Epoch 1 (Survey visit) (approximately 35 days)|The According to Protocol (ATP) cohort included all evaluable subjects for whom at least one laboratory result of the blood sample was available.|||Participants|||Count of Participants
2620518|NCT01954251|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From first vaccination up to Month 18 (study end)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
2620519|NCT01954251|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination up to Month 18 (study end)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
2620520|NCT01954251|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During 30 days (Days 0-29) after vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
2620521|NCT01954251|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0-6) across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.|||Subjects|||Number
2620522|NCT01954251|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.|||Subjects|||Number
2620523|NCT01954251|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Days 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.|||Subjects|||Number
2620524|NCT01954251|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|Within 7 days (Days 0-6) across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.|||Subjects|||Number
2620525|NCT01954251|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 (G3) pain = pain that prevented normal activity. Grade 3 (G3) redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|Within 7 days (Days 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered, on subjects with their symptom sheets completed.|||Subjects|||Number
2620527|NCT01954251|Secondary|Number of Seroconverted Subjects in Terms of HI Antibodies|The number of seroconverted subjects was assessed in terms of HI antibodies against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts/2/2012 Yamagata.|At Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2620528|NCT01954251|Secondary|FLU Haemagglutination Inhibition (HI) Antibody Titers|HI antibody titres against the four influenza vaccine strains Flu A/California/7/2009, Flu A/Texas/50/2012, Flu B/Brisbane/60/2008 Victoria (Vic) and Flu B/Massachusetts (Massach)/2/2012 Yamagata (Yamma) were expressed as geometric mean titers (GMTs).|At Day 0 (PRE) and Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2620529|NCT01954251|Secondary|Number of Seroprotected Subjects With HI Antibody Titers ≥ 1:40|Seroprotection rate is defined as the percentage of vaccines with a serum HI titer ≥1:40 that usually was accepted as indicating protection. FLU HI antibodies were assessed in four strains: Flu A/California/7/2009 H1N1, Flu A/Texas/50/2012 H3N2, Flu B/Brisbane/60/2008 Victoria (Vic) and Flu B/Massachusetts(Massach)/2/2012 Yamagata (Yama).|At Day 0 (PRE) and at Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2620530|NCT01954251|Secondary|Number of Subjects With FLU HI Antibody Titers ≥1:10|FLU HI antibodies were assessed in four strains: Flu A/California/7/2009 H1N1, Flu A/Texas/50/2012 H3N2, Flu B/Brisbane/60/2008 Victoria and Flu B/Massachusetts (Massach)/2/2012 Yamagata (Yama). Cut-off titer for seropositivity was 1:10.|At Day 0 (PRE) and 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2620531|NCT01954251|Primary|FLU Haemagglutination Inhibition (HI) Antibody Titers|"For each strain included in the FLU-D-QIV vaccine, an ANOVA model was used to analyze post-vaccination log-transformed titers. The fixed-effect model included the minimization variable (age cohorts) and the treatment as fixed effect. The pre-vaccination log-transformed concentrations were included as continuous covariate. Geometric Means (GM) of post-vaccination titers (Day 21) were calculated conditionally to the means of the pre-vaccination log-transformed titers (Month 0) for each strain.~Adjusted GMTs (GMTs adjusted for baseline titers) and Adjusted GMT ratios were calculated together with 2-sided 95% CIs."|At Day 21 post vaccination|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2620532|NCT01954251|Primary|Adjusted Geometric Mean ELISA Concentrations of Anti-gE Antibodies|Geometric means (GMs) of post-vaccination concentrations (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group) was calculated conditionally to the means of the pre-vaccination log-transformed concentrations for anti-gE (Month 0 for GSK1437173A + GSK2321138A group and Month 2 for Control group). Adjusted Least Squares (LS) means and difference of LS means between the groups were calculated together with 2-sided 95% CIs and back-transformed to the original units to provide GMCs.|At one month post-dose 2 (Month 3 for GSK1437173A + GSK2321138A group and Month 5 for Control group)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2620533|NCT01954251|Primary|Vaccine Response for Anti-gE Humoral Immunogenicity|"The vaccine response(VRR) for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA),was assessed only in subjects from the GSK1437173A + GSK2321138A Group. The VRR for anti-gE was defined as the percentage of subjects who had at least:~a 4-fold increase in the post-dose 2 anti-gE antibody concentration as compared to the pre-vaccination anti-gE antibody concentration, for subjects who were seropositive at baseline (cut-off ≥ 97 mIU/ml), or, a 4-fold increase in the post dose 2 anti-gE antibody concentrations as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who were seronegative at baseline (cut-off < 97 mIU/ml).Criterion used: the objective was met if the Lower Limit (LL) of the 95% confidence interval (CI) of the VRR for anti-gE antibody concentrations was at least 60%."|At one month post-dose 2 (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.|||Percentage||95% Confidence Interval|Number
2620534|NCT01954251|Primary|Number of Subjects With Vaccine Response to Anti-gE Antibodies|The vaccine response(VRR) for anti-gE humoral immunogenicity, as determined by enzyme-linked immunosorbent assay (ELISA),was assessed only in subjects from the GSK1437173A + GSK2321138A Group. The VRR for anti-gE was defined as the percentage of subjects who had at least: a 4-fold increase in the post-dose 2 anti-gE antibody concentration as compared to the pre-vaccination anti-gE antibody concentration, for subjects who were seropositive at baseline (cut-off ≥ 97 mIU/ml), or, a 4-fold increase in the post dose 2 anti-gE antibody concentrations as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who were seronegative at baseline (cut-off < 97 mIU/ml).|At one month post-dose 2 (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2620562|NCT01954121|Secondary|Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug|Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.|From Randomization (Week 1) up to Evaluation Visit (Week 30)|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.|||events|||Number
2620563|NCT01954121|Secondary|Time to First Seizure During the Evaluation Period|Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.|From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.|||events|||Number
2620564|NCT01954121|Secondary|Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period|Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.|From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.|||events|||Number
2620565|NCT01954121|Secondary|Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period||From Week 1 to Week 30|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.|||percentage of subjects|||Number
2620566|NCT01954121|Primary|Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period||6-months Evaluation Period (From Week 4 to Week 30)|The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock.|||percentage of subjects|||Number
2620567|NCT01954082|Other Pre-specified|Overall Health Status|Overall health status per recall from the parent/guardian (including survival, re-hospitalizations, surgeries, ongoing medications, and chronic illnesses).|22-26 Months Corrected Age|||||||
2620568|NCT01954082|Other Pre-specified|Cerebral Palsy|Cerebral palsy by severity category (absent/mild/moderate/severe).|22-26 Months Corrected Age|||||||
2620569|NCT01954082|Other Pre-specified|Hearing Loss|Hearing loss requiring that hearing aids be prescribed.|22-26 Months Corrected Age|||||||
2620570|NCT01954082|Other Pre-specified|Vision Loss|"Vision loss as diagnosed by an ophthalmologist as legally blind, and subdivided into ophthalmic origin, or not ophthalmic origin (i.e., cortical blindness is non-ophthalmic in origin and indicates that there is no retinal detachment or other abnormal fundus or ocular finding, except optic atrophy. Such cases will be considered central [neurologic] in origin.)"|22-26 Months Corrected Age|||||||
2620571|NCT01954082|Other Pre-specified|Neurodevelopment|Neurodevelopment at 22-26 months corrected age (i.e., 22-26 months past due date) using the Bayley Scales of Infant Development III.|22-26 months corrected age|||||||
2620572|NCT01954082|Other Pre-specified|Hearing Loss|Hearing loss as defined as never passing a hearing screening in one or both ears|NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth|||||||
2620573|NCT01954082|Other Pre-specified|Days on Oxygen, Days on Ventilator||NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth|||||||
2620574|NCT01954082|Other Pre-specified|Total Days on Parenteral Nutrition|Total days on parenteral nutrition (including amino acids and/or lipids)|NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth|||||||
2620575|NCT01954082|Other Pre-specified|Seizures|Seizures treated with an anticonvulsant for >72 hours|NRN infant status, i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth|||||||
2620576|NCT01954082|Other Pre-specified|Patent Ductus Arteriosus (PDA)|Occurrence of clinically significant patent ductus arteriosus (PDA), and if received intervention with prostaglandin inhibitors, and/or surgery.|NRN infant status, i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth|||||||
2620577|NCT01954082|Other Pre-specified|Late Onset Sepsis|culture positive septicemia/bacteremia (≥72 hours of age) treated with antibiotics for ≥ 5 days or died before treatment was completed.|NRN infant status, i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth|||||||
2620578|NCT01954082|Other Pre-specified|Isolated Gastrointestinal Perforation|judged not to be due to NEC|NRN infant status, i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth|||||||
2620579|NCT01954082|Other Pre-specified|Necrotizing Enterocolitis (NEC)|Stage II or worse, whether treated (medically or surgically) and if the infant survived (modified Bell's classification [Walsh 1986]).|NRN infant status, i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth|||||||
2620580|NCT01954082|Other Pre-specified|The Occurrence of Adverse Events and Serious Adverse Events||7 days post study drug discontinuation|||||||
2620581|NCT01954082|Secondary|Number of Participants With Severe Intraventricular Hemorrhage (IVH)|Severe IVH is defined as IVH Grades 3 or 4 on either side of the brain. The evaluation for IVH occurs early (within 28 days from birth) via a cranial sonogram and is classified as described by Papile.|by 28 days PMA|The analysis was performed on an intention to treat basis. Individuals for whom severe IVH status could not be defined were treated as missing completely at random, and excluded from the analyses (6 Inositol and 4 Placebo).|||Participants|||Count of Participants
2620582|NCT01954082|Secondary|Number of Participants With Type 2 or More Severe Retinopathy of Prematurity (ROP)|Defined as one or both eyes reaching Type 2 ROP (ETROP 2003) or the more severe Type 1 ROP (as defined previously) through the time that Acute/Final ROP status is reached (up to 55 weeks postmenstrual age (PMA)). Type 2 ROP is defined as (ETROP 2003): Stage 3 ROP without Plus Disease (i.e. Zone II) or Stage 1 or 2 ROP without Plus Disease (i.e. Zone I).|by 55 weeks PMA|The analysis was performed on an intention to treat basis. Individuals for whom ROP status and/or type could not be defined were treated as missing completely at random, and excluded from the analyses (54 Inositol and 36 Placebo).|||Participants|||Count of Participants
2620583|NCT01954082|Secondary|Number of Participants With Any Retinopathy of Prematurity (ROP)|ROP was identified by routine ophthalmologic examinations beginning at the latter of 31 weeks PMA or 4-6 weeks chronologic age. Any ROP is defined as ROP of any severity that is observed on at least 2 independent examinations in either eye through the time that Acute/Final ROP status is reached (up to 55 weeks postmenstrual age (PMA)).|by 55 weeks PMA|The analysis was performed on an intention to treat basis. Individuals for whom ROP status could not be defined were treated as missing completely at random, and excluded from the analyses (50 Inositol and 35 Placebo).|||Participants|||Count of Participants
2620584|NCT01954082|Secondary|Number of Participants With All Cause Death Before Retinopathy of Prematurity (ROP) Endpoint|Defined as death from any cause following randomization through primary study follow-up (up to 55 weeks postmenstrual age (PMA))|by 55 weeks PMA age|The analysis was performed on an intention to treat basis.|||Participants|||Count of Participants
2620585|NCT01954082|Secondary|Number of Participants With Bronchopulmonary Dysplasia (BPD) or Death From BPD|BPD is defined as supplemental oxygen required to maintain an oxygenation saturation of >90% at 36 weeks PMA (NICHD physiologic definition). Death from BPD prior to 37 weeks postmenstrual age (PMA) is defined when the cause of death is certified by the Center PI as BPD being the primary cause, or a significant co-contributing cause of death.|prior to 37 weeks PMA|The analysis was performed on an intention to treat basis. Individuals who died prior to 37 weeks PMA for whom the cause(s) of death are unknown or individuals for whom BPD outcome could not be obtained were treated as missing completely at random, and excluded from the analyses (1 Inositol and 5 Placebo).|||Participants|||Count of Participants
2620586|NCT01954082|Secondary|Number of Participants With Bronchopulmonary Dysplasia (BPD)|BPD is defined as supplemental oxygen required to maintain an oxygenation saturation of >90% at 36 weeks postmenstrual age (PMA) (NICHD physiologic definition).|36 weeks PMA|The analysis was performed on an intention to treat basis. Individuals for whom BPD outcome could not be obtained were treated as missing completely at random, and excluded from the analyses (45 Inositol and 33 Placebo).|||Participants|||Count of Participants
2620587|NCT01954082|Primary|Number of Participants With Unfavorable Outcome, Defined as Severe Retinopathy of Prematurity (ROP) or Death Prior to Reaching Acute/Final ROP Status|Death is defined as from any cause before Acute/Final ROP status is determined. ROP was identified by routine ophthalmologic examinations beginning at the latter of 31 weeks PMA or 4-6 weeks chronologic age. The favorable ROP endpoint requires that no ROP, or only mild ROP has occurred in both eyes and the eyes have matured beyond the risk of developing Type 1 ROP (severity meeting criteria for surgical intervention). The unfavorable ROP endpoint requires that one or both eyes reach Type 1 ROP. When ROP did not resolve by the time of discharge, participants were followed as outpatients until reaching an ROP endpoint, up to 55 weeks PMA. Since incomplete follow up is more likely among participants with mild or no ROP than for those with aggressive ROP, an independent adjudication process assigned an ROP endpoint of 'most likely never had Type 1 ROP', or 'most likely developed Type 1 ROP' based on clinical and ROP data review to reduce possible missing data bias.|by 55 weeks PMA|The analysis was performed on an intention to treat basis, including adjudicated ROP endpoints. Individuals for whom adjudicated ROP endpoints could not be obtained were treated as missing completely at random, and excluded from the primary analyses (4 Inositol and 1 Placebo).|||Participants|||Count of Participants
2620588|NCT01954056|Secondary|Number of Boluses Given|The number of fluid boluses given per participant, if any, before or during study drug administration between birth and 60 days of life|Birth to 60 days of life|The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.|||Boluses||Full Range|Median
2620589|NCT01954056|Secondary|Number of Participants With Fluid Boluses Given|This is measured as Yes if an infant received fluid boluses anytime before or during study drug administration between birth and 60 days of life; Otherwise, No.|Birth to 60 days of life|The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.|||Participants|||Count of Participants
2620590|NCT01954056|Secondary|Respiratory Severity|This is calculated as fraction of inspired oxygen (FiO2), as a percentage, multiplied by the mean airway pressure during study drug administration. Higher score means more severe.|Birth to 60 days of life|The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.|||Percentage of inspired oxygen * cmH2O||Standard Deviation|Mean
2620591|NCT01954056|Secondary|Oxygenation Index|This is calculated as fraction of inspired oxygen (FiO2), as a percentage, multiplied by the mean airway pressure divided by partial pressure of oxygen in arterial blood (PaO2), during study drug administration. A lower oxygenation index is better.|Birth to 60 days of life|The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.|||Oxygenation Index||Standard Deviation|Mean
2620592|NCT01954056|Secondary|Maximum Inotrope Dose|This is calculated as the maximum dose of all inotropes in the 10 days following the initiation of study drug administration. For the purposes of this calculation, dopamine and dobutamine doses were considered equivalent and 0.01 mcg/kg/min of epinephrine was equal to 5 mcg/kg/min of dopamine.|From start of study drug administration (7 days) through 3 days post study drug administration.|The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.|||mcg/kg/min||Standard Deviation|Mean
2620593|NCT01954056|Secondary|Inotrope Duration|This is calculated as the number of days on inotropes starting 24 hours prior to initiation of study drug, during the 7-day study drug administration period, and for 3 days after the study drug.|24 hours prior to study drug administration through 3 days post study drug administration.|The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.|||days||Full Range|Median
2620594|NCT01954056|Secondary|Number of Participants With Inotrope Exposure|This is measured as Yes if an infant was receiving inotropes on the specific day after the initiation of study drug.|24 hours prior to study drug administration through 3 days post study drug administration.|The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.|||Participants|||Count of Participants
2620595|NCT01954056|Secondary|Number of Participants With Need for ECMO Therapy|This is measured as Yes if an infant received ECMO treatment anytime between birth and 60 days of life; Otherwise, No. Extracorporeal membrane oxygenation (ECMO) is a treatment that uses a pump to circulate blood through an artificial lung back into the bloodstream of a very ill baby.|Birth to 60 days of life|The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.|||Participants|||Count of Participants
2620596|NCT01954056|Secondary|Number of Participants With Necrotizing Enterocolitis|This is measured as Yes if an infant necrotizing enterocolitis (NEC) between birth and 60 days of life; Otherwise, No. NEC could be proven with or without surgery|Birth to 60 days of life|The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.|||Participants|||Count of Participants
2620597|NCT01954056|Secondary|Number of Participants With Renal Insufficiency|This is measured as Yes if an infant had renal insufficieny between birth and 60 days of life; Otherwise, No. Renal insufficiency is defined as creatinine less than 2 during 7 days after first treatment|Birth to 60 days of life|The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.|||Participants|||Count of Participants
2620598|NCT01954056|Secondary|Hospital Length of Stay|This is measured as the number of days between birth and 60 days of life that an infant was in the hospital. Infants who died or transferred to another care facility were not included.|Birth to 60 days of life|The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.|||Days||Full Range|Median
2620599|NCT01954056|Secondary|Number of Participants With Need for Home Oxygen|This is measured as Yes if an infant was discharged to home while on oxygen between birth and 60 days of life; Otherwise, No.|Birth to 60 days of life|The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.|||Participants|||Count of Participants
2620600|NCT01954056|Secondary|Duration of Oxygen Requirement|This is measured as the number of days between birth and 60 days of life that an infant was on oxygen in the hospital.|Birth to 60 days of life|The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.|||Days||Full Range|Median
2620601|NCT01954056|Secondary|Number of Participants With Need for Gastronomy Tube|This is measured as Yes if a gastronomy tube was placed anytime prior to final status between birth and 60 days of life; Otherwise, No|Birth to 60 days of life|The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.|||Participants|||Count of Participants
2620602|NCT01954056|Secondary|Days to Full Feeds|The day of life at which full nipple feeds were reached between birth and 60 days of life. Full nipple feeds are defined as at least 120 mg/kg/day.|Birth to 60 days of life|The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. Excludes 4 infants (Hydrocortisone: 1, Placebo: 3) without information on full feeds.|||Days||Full Range|Median
2620603|NCT01954056|Secondary|Duration of Mechanical Ventilation|This is measured as the number of days between birth and 60 days of life of mechanical ventialtion of laryngeal intubation.|Birth to 60 days of life|The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.|||Days||Full Range|Median
2620604|NCT01954056|Primary|Number of Participants With Death or Neurodevelopmental Impairment|A composite outcome that measures the occurrence of death or neurodevelomental impairment between birth and 22-26 months corrected gestational age.|Birth to 22-26 months corrected gestational age|The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.|||Participants|||Count of Participants
2620605|NCT01954056|Primary|Number of Participants With Neurodevelopmental Impairment|This is measured as Yes if an any hearing impairment or visual impairment is noted, if non-normal gross motor function level is noted, any seizures have been noted, or if the cognitive, language, or motor scores of the Bayley III score are more than 1 standard deviation below the average; Otherwise, No.|Birth to 22-26 months corrected gestational age|The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.|||Participants|||Count of Participants
2620743|NCT01952665|Secondary|Participant Recommendation of a Study Lens|Participant most likely recommendation of which study lens to friends, family or colleagues. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2).|4 weeks||||participants|||Number
2620606|NCT01954056|Primary|Death|This is measured as Yes if an infant died between birth and 22-26 months corrected gestational age; Otherwise, No.|Birth to 22-26 months corrected gestational age|The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.|||Participants|||Count of Participants
2620607|NCT01954017|Secondary|Number of Patients With Fecal Shedding of STP6 and STP11 in High-Dose Treatment Groups|The presence of STP6 and STP11 was assessed in fecal cultures.|Prior to Week 1 Day 4 and at end of dosing/hospital discharge, up to 781 days|Safety population|||participants|||Number
2620608|NCT01954017|Secondary|Number of Patients With Fecal Shedding of STP6 and STP11 in Low-Dose Treatment Groups|The presence of STP6 and STP11 was assessed in fecal cultures.|Prior to Week 1 Day 4 and at end of dosing/hospital discharge, up to 781 days|Safety population|||participants|||Number
2620609|NCT01954017|Secondary|Number of Patients With Bronchopulmonary Dysplasia in High-Dose Treatment Groups|"Mild to Moderate = Need for < 30% O2 at 36 wk postmenstrual age (PMA) or discharge, whichever comes first.~Severe = Need for ≥ 30% O2, positive pressure or both at 36 wk PMA or discharge, whichever comes first.~For each event type, patients are counted only once if they had one or more events as this table tabulates the percentage of patients with one or more events."|Start of dosing to 6 months||||Participants|||Count of Participants
2620610|NCT01954017|Secondary|Number of Patients With Bronchopulmonary Dysplasia in Low-Dose Treatment Groups|"Mild to Moderate = Need for < 30% O2 at 36 wk postmenstrual age (PMA) or discharge, whichever comes first.~Severe = Need for ≥ 30% O2, positive pressure or both at 36 wk PMA or discharge, whichever comes first.~For each event type, patients are counted only once if they had one or more events as this table tabulates the percentage of patients with one or more events."|Start of dosing to 6 months||||Participants|||Count of Participants
2620611|NCT01954017|Secondary|Number of Patients With Intraventricular Hemorrhage in High-Dose Treatment Groups|IVH was assessed by cranial ultrasound between the ages of 5 and 7 days and, if clinically indicated and the neonate remained hospitalized, at 28 days. IVH is graded from I to IV, with increasing severity.|From 5 days to 28 days||||Participants|||Count of Participants
2620612|NCT01954017|Secondary|Number of Patients With Intraventricular Hemorrhage in Low-Dose Treatment Groups|IVH was assessed by cranial ultrasound between the ages of 5 and 7 days and, if clinically indicated and the neonate remained hospitalized, at 28 days. IVH is graded from I to IV, with increasing severity.|From 5 days to 28 days||||Participants|||Count of Participants
2620613|NCT01954017|Secondary|Number of Patients With Retinopathy of Prematurity in High-Dose Treatment Groups|ROP in each eye was assessed by indirect ophthalmoscope after pupillary dilation. ROP is categorized in zones 1 to 3, the lower number representing the smallest area affected, and stages 0 to 5, the lowest number indicating the mildest form and the highest number indicating retinal detachment.|Start of dosing to 6 months||||Participants|||Count of Participants
2620614|NCT01954017|Secondary|Number of Patients With Retinopathy of Prematurity in Low-Dose Treatment Groups|ROP in each eye was assessed by indirect ophthalmoscope after pupillary dilation. ROP is categorized in zones 1 to 3, the lower number representing the smallest area affected, and stages 0 to 5, the lowest number indicating the mildest form and the highest number indicating retinal detachment.|Start of dosing to 6 months|Intent-to-Treat|||Participants|||Count of Participants
2620615|NCT01954017|Secondary|Number of Patients With Feeding Intolerance in High-Dose Treatment Groups|Feeding tolerance was evaluated by abdominal evaluation (any excessive distension beyond what is expected with a feed, redness of abdominal wall, firmness, presence of normal bowel sounds). Neonates placed on NPO status for at least 12 hours were considered to have feeding intolerance.|Start of dosing to 6 months|Intent-to-Treat|||Participants|||Count of Participants
2620616|NCT01954017|Secondary|Number of Patients With Feeding Intolerance in Low-Dose Treatment Groups|Feeding tolerance was evaluated by abdominal evaluation (any excessive distension beyond what is expected with a feed, redness of abdominal wall, firmness, presence of normal bowel sounds). Neonates placed on NPO status for at least 12 hours were considered to have feeding intolerance.|Start of dosing to 6 months|Intent-to-Treat|||Participants|||Count of Participants
2620617|NCT01954017|Secondary|Number of Patients With Sepsis in High-Dose Treatment Groups|The presence of STP6 and STP11 was assessed in peripheral blood cultures.|Start of dosing to 6 months|Intent-to-Treat|||Participants|||Count of Participants
2620618|NCT01954017|Secondary|Number of Patients With Sepsis in Low-Dose Treatment Groups|The presence of STP6 and STP11 was assessed in peripheral blood cultures.|Start of dosing to 6 months|Intent-to-Treat|||Participants|||Count of Participants
2620619|NCT01954017|Secondary|Number of Patients With Confirmed Necrotizing Enterocolitis in High-Dose Treatment Groups|NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe).|Start of dosing to 6 months|Intent-to-Treat|||Participants|||Count of Participants
2620620|NCT01954017|Secondary|Number of Patients With Confirmed Necrotizing Enterocolitis in Low-Dose Treatment Groups|NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe).|Start of dosing to 6 months|Intent-to-Treat|||Participants|||Count of Participants
2620621|NCT01954017|Secondary|Number of Patients With Suspected Necrotizing Enterocolitis in High-Dose Treatment Groups|NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe).|Start of dosing to 6 months|Intent-to-Treat|||Participants|||Count of Participants
2620622|NCT01954017|Secondary|Number of Patients With Suspected Necrotizing Enterocolitis in Low-Dose Treatment Groups|NEC is staged from I to III, from suspected to definite to advanced. The 3 stages are further divided into A (less severe) and B (more severe).|Start of dosing to 6 months|Intent-to-Treat|||Participants|||Count of Participants
2620652|NCT01953874|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ)|The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
2620623|NCT01954017|Primary|Growth Assessment Classification in High-Dose Treatment Groups|"AGA is defined as both body weight (g) and head circumference (cm) are between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0.~SGA/Head-Spared is defined as body weight(g) is <10th percentile, and head circumference(cm) is between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0.~SGA/Head-Symmetric is defined as both body weight(g) and head circumference(cm) are <10th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0.~LGA is defined as both body weight(g) and head circumference(cm) are >90th percentile according to the growth percentile charts in Appendix D of Protocol v3.0."|End of dosing/hospital discharge, up to 781 days|Safety population|||participants|||Number
2620624|NCT01954017|Primary|Growth Assessment Classification in Low-Dose Treatment Groups|"Accelerated growth area (AGA) is defined as both body weight (g) and head circumference (cm) are between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0.~Small for gestational age (SGA) SGA/Head-Spared is defined as body weight(g) is <10th percentile, and head circumference(cm) is between 10th percentile and 90th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0.~SGA/Head-Symmetric is defined as both body weight(g) and head circumference(cm) are <10th percentile according to the gender specific growth percentile charts in Appendix D of Protocol v3.0.~Large for gestational age (LGA) is defined as both body weight(g) and head circumference(cm) are >90th percentile according to the growth percentile charts in Appendix D of Protocol v3.0."|End of dosing/hospital discharge, up to 781 days|Safety|||Participants|||Count of Participants
2620625|NCT01954017|Primary|Serious Adverse Events Experienced by Subjects in High-Dose Treatment Groups|Serious adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug|30 days after last administration of study drug|Safety|||Participants|||Count of Participants
2620626|NCT01954017|Primary|Serious Adverse Events Experienced by Subjects in Low-Dose Treatment Groups|Serious adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug|30 days after last administration of study drug|Safety|||Participants|||Count of Participants
2620627|NCT01954017|Primary|Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups|Grade 3 treatment-emergent adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug|30 days after last administration of study drug|Safety|||Participants|||Count of Participants
2620628|NCT01954017|Primary|Grade 3 Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups|Grade 3 treatment-emergent adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug|30 days after last administration of study drug|Safety|||Participants|||Count of Participants
2620629|NCT01954017|Primary|Treatment-emergent Adverse Events Experienced by Subjects in High-Dose Treatment Groups|Treatment-emergent adverse events experienced by subjects in high-dose treatment groups within 30 days of last exposure to study drug|30 days after last administration of study drug|Safety population|||Participants|||Count of Participants
2620630|NCT01954017|Primary|Treatment-emergent Adverse Events Experienced by Subjects in Low-Dose Treatment Groups|Treatment-emergent adverse events experienced by subjects in low-dose treatment groups within 30 days of last exposure to study drug|30 days after last administration of study drug|Safety population|||Participants|||Count of Participants
2620631|NCT01954017|Primary|Number and Severity of Adverse Events Experienced by Subjects in High-Dose Treatment Groups|The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups|30 days after the last dose of blinded study treatment|Safety population|||Participants|||Count of Participants
2620632|NCT01954017|Primary|Number and Severity of Adverse Events Experienced by Subjects in Low-dose Treatment Groups|The number and severity of adverse events, adverse events leading to study drug discontinuation, and number of deaths experienced by subjects randomized to the low-dose treatment groups|30 days after the last dose of blinded study treatment|Safety population|||Participants|||Count of Participants
2620633|NCT01953913|Secondary|Percentage of Participants With Drug-related (Afatinib-related) Adverse Events|Percentage of participants with drug-related (afatinib-related) adverse events.|From first drug administration up to 28 days after last drug administration, up to 1624 days.|TS|||Percentage of participants (%)|||Number
2620634|NCT01953913|Secondary|Time to Symptomatic Progression (TTSP)|Time to Symptomatic progression (TTSP) was defined as time from first administration of afatinib to date of first documented clinically significant symptomatic progression that required stopping the anti-cancer treatment according to investigator's assessment. 95% confidence intervals (CIs) for the median was calculated for TTSP using Greenwood' standard error estimate.|From first drug administration until date of first documented clinically significant symptomatic progression that required stopping afatinib treatment, up to 1624 days.|TS|||Months||95% Confidence Interval|Median
2620635|NCT01953913|Primary|Percentage of Participants With Serious Adverse Events (SAEs)|Percentage of participants with serious adverse events (SAEs).|From first drug administration up to 28 days after last drug administration, up to 1624 days.|Treated set (TS): It included all patients who were dispensed trial medication and documented to take at least one dose of investigational treatment (afatinib).|||Percentage of participants (%)|||Number
2620636|NCT01953874|Secondary|ESS|The Epworth Sleepiness Scale is a simple, 8-item self-administered questionnaire which provides a measurement of the subject's general level of daytime sleepiness. The individual is asked on a scale of 0-3 to score the likelihood of falling asleep in eight various situations. With a total range of 0 to 24, a higher score indicates increased severity.|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
2620653|NCT01953874|Secondary|NT Pro-BNP|Change in neurohumoral activation as measured by N-terminal pro b-type natriuretic peptide.|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||pg/mL||Standard Deviation|Mean
2620637|NCT01953874|Secondary|PSQI|"The Pittsburgh Sleep Quality Index is a 19-item subjective measurement of sleep. It is an effective instrument used to measure the quality and patterns of sleep in the older adult. It differentiates poor from good sleep by measuring seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction over the last month. The subject self-rates each of these seven areas of sleep. The seven component scores are then added to yield a total score with a range of 0-21 points, 0 indicating no difficulty and 21 indicating severe difficulties in all areas."|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
2620638|NCT01953874|Secondary|PHQ-9|The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a self-administered instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self-report tool. The tool rates the frequency of the symptoms which factors into the following scoring severity index: 0 - Not at all, 1 - Several Days, 2 - More than Half the Days, 3 - Nearly Every Day. Total score can range from 0 to 27. A higher score indicates increased severity.|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis|||scores on a scale||Standard Deviation|Mean
2620639|NCT01953874|Secondary|EQ-5D-5L Index|The EQ-5D-5L is a standardized self-report questionnaire that is used as a measure of health outcome. The EQ-5D-5L questionnaire is comprised of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses were indexed using the EQ-5D-5L US value set to scale the 5 dimensions. A score of -0.109 indicates extreme problems for all dimensions and a score of 1.000 indicates no problems for all dimensions. Therefore, a higher score indicates better general health.|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
2620640|NCT01953874|Secondary|DASI|The Duke Activity Status Index is a 12-item patient-reported outcome validated for the assessment of functional capacity based on the ability to perform everyday activities. With a total range of 0 to 58.20, a higher score indicates better quality of life.|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||scores on a scale||Standard Deviation|Mean
2620641|NCT01953874|Secondary|Time Dead/Hospitalized|Total days dead or hospitalized at study end|6 months||||number of days||Standard Deviation|Mean
2620642|NCT01953874|Secondary|Death|Rate of Cardiovascular and all-cause death|2 days, 1 week, 1, 2, 3, and 6 months||||Participants|||Count of Participants
2620643|NCT01953874|Secondary|Number of Subjects With HF Hospitalization|Rates of hospitalization or urgent clinic visit for worsening of heart failure and for any reason|2 days, 1 week, 1, 2, 3, and 6 months||||Participants|||Count of Participants
2620644|NCT01953874|Secondary|Sleep Parameters|Sleep and sleep disordered breathing parameters (AHI, nocturnal hypoxemia)|Change from Baseline to 6 months|Not all subjects in the active arm successfully measured ODI. For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||events per hour||Standard Deviation|Mean
2620645|NCT01953874|Secondary|Win Ratio|Patients in the new treatment and control groups are formed into matched pairs based on their risk profiles. For each matched pair, the new treatment patient is labeled a 'winner' or a 'loser' depending on who had a CV death first. If that is not known, they are labeled a 'winner' or 'loser' depending on who had a HF hospitalization first. Otherwise they are considered tied. The win ratio is the total number of winners divided by the total numbers of losers.|6 months||||Ratio||95% Confidence Interval|Number
2620646|NCT01953874|Secondary|ECHO Parameters - E/e' Ratio|Echocardiographic parameters, including LVEF (left ventricular ejection fraction) and LVESVI (left ventricular end-systolic volume index) for patients with HFrEF (heart failure with reduced ejection fraction), and E/e' (ratio between early mitral inflow velocity and mitral annular early diastolic velocity) for patients with HFpEF (heart failure with preserved ejection fraction).|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis. HFrEF and HFpEF subjects were separated accordingly.|||ratio||Standard Deviation|Mean
2620647|NCT01953874|Secondary|ECHO Parameters - LVESVI|Echocardiographic parameters, including LVEF (left ventricular ejection fraction) and LVESVI (left ventricular end-systolic volume index) for patients with HFrEF (heart failure with reduced ejection fraction), and E/e' (ratio between early mitral inflow velocity and mitral annular early diastolic velocity) for patients with HFrEF or HFpEF (heart failure with preserved ejection fraction).|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||mL/m^2||Standard Deviation|Mean
2620648|NCT01953874|Secondary|ECHO Parameters - LVEF|Echocardiographic parameters, including LVEF (left ventricular ejection fraction) and LVESVI (left ventricular end-systolic volume index) for patients with HFrEF (heart failure with reduced ejection fraction), and E/e' (ratio between early mitral inflow velocity and mitral annular early diastolic velocity) for patients with HFrEF or HFpEF (heart failure with preserved ejection fraction).|Change from Baseline to 6 months|For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||%EF||Standard Deviation|Mean
2620649|NCT01953874|Secondary|Biomarkers - Renal Function|Biomarkers of renal function reported as creatinine|Change from Baseline to 6 months|Not all participants had biomarker samples that were able to be analyzed. For endpoints that needed a change in measures from baseline to 6 months, if a subject missed one of the measurements, the subject was excluded from the analysis.|||mg/dL||Standard Deviation|Mean
2620690|NCT01953328|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2620654|NCT01953874|Secondary|Six-minute Walk Distance|Change in functional parameters as measured by 6-minute walk test (6MWT)|Change from Baseline to 6 months|"Reasons 6MWT was not performed:~In the MV ASV+OMT arm, 5 were discontinued prematurely, 3 participants could not walk, 4 participants were too critically ill, and 2 participants refused.~In the OMT only arm, 12 were discontinued prematurely, 1 participant could not walk, and 2 participants refused."|||meters||Standard Deviation|Mean
2620655|NCT01953874|Primary|Global Rank Endpoint|A rank order response based on survival free from CV hospitalization and improvement in functional capacity measured by 6MWD. All participants were first ranked by time to death, then ranked by time to CV hospitalization, and then ranked by percentage change in 6MWD. For time to event measures (time to death and time to hospitalization), the shorter the amount of time, the lower the rank assigned to that participant. For percentage changes in 6MWD, the smaller the percentage change, the lower the rank assigned to that participant. Each component was then combined to create a rank value that ranged between 0 and 100. Overall, higher rank values are associated with better outcomes.|Baseline, 6 months||||Standardized global rank order value||Standard Deviation|Mean
2620656|NCT01953601|Secondary|Part 1 (Base Study). Mean Percent Change From Baseline in Cerebrospinal Fluid (CSF) Total Tau Concentration at Week 104|Mean percent change from baseline at week 104 was calculated for Total Tau concentration in CSF, a measure of brain tau pathology. Per protocol, CSF Total Tau concentration was analyzed as part of a substudy in Part 1, with testing occurring only at select trial sites.|Baseline and Week 104 in Part 1|Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose observation for CSF Total Tau concentration; and 2) tested positive for cortical amyloid load by PET. CSF Total Tau concentration was analyzed at select trial sites as a Part 1 substudy.|||Percent Change||Standard Deviation|Mean
2620657|NCT01953601|Secondary|Part 1 (Base Study). Least Squares Mean Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment Version) (ADCS-ADL MCI) Score at Week 104|Least squares mean change from baseline at week 104 was assessed for the ADCS-ADL MCI score. The ADCS-ADL MCI is an 18-item assessment of recent, observed performance of activities of daily living administered to participants' trial partners in an interview format. For the 18 items, scores range from 0 (no independence) to (depending on the item) either 2 (5 items), 3 (9 items), or 4 (4 items), with higher scores indicating greater independence in activity performance. Scores from individual items sum to a total ADCS-ADL score (range: 0-53). Lower scores indicate less independence in activity performance and, as a result, greater AD severity. Further, increases in AD severity over time would be reflected by decreases in ADCS-ADL score.|Baseline and Week 104 in Part 1|Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose ADCS-ADL MCI observation; and 2) tested positive for cortical amyloid load by PET.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2620658|NCT01953601|Secondary|Part 1 (Base Study). Least Squares Mean Change From Baseline in Composite Cortical Amyloid Standard Uptake Value Ratio (SUVR) Assessed With Amyloid Tracer [18F]Flutemetamol Using Positron Emission Tomography (PET) Imaging at Week 104|[18F]Flutemetamol PET SUVR measures brain cortical amyloid load. The PET tracer [18F]Flutemetamol was given intravenously (IV). After 90 minutes, participants were scanned for 20 minutes. Using the PET scan images, SUVRs, the ratio of tracer signal in a specific region compared to a reference region (RR; subcortical white matter) are calculated for brain regions of interest (ROIs). SUVRs from a selected set of brain regions are averaged to compute a composite SUVR. Higher composite SUVR values indicate increased amyloid load in selected brain regions, with negative changes in composite cortical SUVR over time indicating decreases in brain amyloid load.|Baseline and Week 104 in Part 1|Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose SUVR observation; and 2) tested positive for cortical amyloid load by PET.|||Standard Uptake Value Ratio (SUVR)||95% Confidence Interval|Least Squares Mean
2620659|NCT01953601|Secondary|Part 1 (Base Study). Least Squares Mean Percent Change From Baseline in Total Hippocampal Volume (THV) at Week 104|Least squares mean percent change from baseline at week 104 was calculated for THV as measured by volumetric magnetic resonance imaging (vMRI). Negative percent changes from baseline indicate decreases in THV (i.e. increased hippocampal atrophy).|Baseline and Week 104 in Part 1|Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose THV observation; and 2) tested positive for cortical amyloid load by PET.|||Percent Change||95% Confidence Interval|Least Squares Mean
2620660|NCT01953601|Secondary|Part 1 (Base Study). Least Squares Mean Change From Baseline in the 3-Domain Composite Cognition Score (CCS-3D) at Week 104|CCS-3D is composed of individual cognitive tests, grouped into 3 domains: 1) episodic memory; 2) executive function; and 3) attention/processing speed. For each cognitive test, a z-score (Z) is calculated at each time point [Z = (observed value - study population mean at baseline) / study population standard deviation at baseline]. These individual Zs are first combined into domain-specific Zs, and then into a composite Z, (i.e. CCS-3D). Theoretically, 99.9% of CCS-3D will be ± 3; more positive CCS-3D indicate greater cognitive impairment relative to the total study population at baseline. Further, negative changes in CCS-3D over time indicate improved cognition relative to the total study population at baseline.|Baseline and Week 104 in Part 1|Includes all participants receiving ≥1 dose of study treatment who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose CCS-3D observation; and 2) tested positive for cortical amyloid load by PET.|||Z-score||95% Confidence Interval|Least Squares Mean
2620661|NCT01953601|Secondary|Part 1 (Base Study). Estimated Least Squares Mean Difference Between the Last (Week 104) and First (Week 13) Post-dose CDR-SB Assessment|LSM difference between weeks 104 and 13 was estimated for CDR-SB score, a clinical rating of global cognitive function, comprised of 6 domains: memory; orientation; judgment / problem solving; community affairs; home / hobbies; and personal care. For each domain, degree of impairment is scored by a semi-structured interview of the participant and the participant's caregiver (domain score range: 0 [no impairment] to 3 [severe impairment]). Domain scores sum to a total CDR-SB score (range: 0-18); higher scores indicate more severe cognitive impairment. Further, increased cognitive impairment is reflected by higher CDR-SB scores; larger differences between week 104 and week 13 scores indicates accelerated AD progression.|Week 13 and Week 104 in Part 1|Includes all participants receiving ≥1 dose of study treatment in Part 1 who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose CDR-SB observation; and 2) tested positive for cortical amyloid load by PET.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2620662|NCT01953601|Secondary|Part 1 (Base Study). Event-Rate Per 100 Participant Years for Progression to a Clinical Diagnosis of Probable AD Dementia|The event-rate per 100 participant-years for progression to a clinical diagnosis of probable AD dementia was calculated. Adjudication of a potential case was triggered if either: 1) in the investigator's own expert judgment, they think the participant may have progressed to dementia and/or 2) the participant's CDR-SB score is ≥2 points higher compared to baseline. Cases of progression to probable AD dementia confirmed by an external adjudication committee were counted as events in the analysis. The event-rate was calculated as the number of events divided by total follow-up time (participant-years) x 100; unit of measure is event-rate / 100 participant-years.|Up to Week 104 in Part 1|Includes all participants receiving ≥1 dose of study treatment in Part 1 who tested positive for cortical amyloid load by PET.|||Event-Rate / 100 Participant-Years|||Number
2620663|NCT01953601|Primary|Part 2 (Extension Study). Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event (AE)|The percentage of participants who discontinued from study drug due to an AE in Part 2 was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product is also an AE.|From Week 104 (start of treatment in Part 2) up to Week 208 (i.e., up to Week 104 in Part 2)|All randomized participants continuing to Part 2, receiving ≥1 dose of trial treatment in Part 2. For included participants, the data reflect discontinuations occurring in Part 2 only.|||Percentage of Participants|||Number
2620664|NCT01953601|Primary|Part 2 (Extension Study). Percentage of Participants Who Experienced ≥1 Adverse Event (AE)|The percentage of participants experiencing an AE in Part 2 was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product is also an AE.|From Week 104 (start of treatment in Part 2) up to Week 210 (up to 2 weeks following cessation of study treatment in Part 2)|All randomized participants continuing to Part 2, receiving ≥1 dose of trial treatment in Part 2. For included participants, the data reflect AEs occurring in Part 2 only.|||Percentage of Participants|||Number
2620665|NCT01953601|Primary|Part 1 (Base Study). Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event (AE)|The percentage of participants who discontinued from study drug due to an AE in Part 1 was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product is also an AE.|Up to Week 104 in Part 1|All randomized participants in Part 1, receiving ≥1 dose of study treatment.|||Percentage of Participants|||Number
2620666|NCT01953601|Primary|Part 1 (Base Study). Percentage of Participants Who Experienced ≥1 Adverse Event (AE)|The percentage of participants experiencing an AE in Part 1 was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product is also an AE.|Up to Week 106 (up to 2 weeks following cessation of study treatment in Part 1)|All randomized participants in Part 1, receiving ≥1 dose of study treatment.|||Percentage of Participants|||Number
2620667|NCT01953601|Primary|Part 2 (Extension Study). Mean Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score at Week 130|Mean change from baseline at week 130 was assessed for CDR-SB score, a clinical rating of global cognitive function, comprised of 6 domains: memory; orientation; judgment and problem solving; community affairs; home and hobbies; and personal care. For each domain, the degree of impairment is assessed by a semi-structured interview of the participant as well as the participant's caregiver. For each domain, potential scores range from 0 (no impairment) to 3 (severe impairment). Individual domain scores are summed to a total CDR-SB score (range: 0-18). Higher scores indicate more severe cognitive impairment. Further, increases in cognitive impairment would be reflected by increases in CDR-SB score. Per protocol, baseline refers to the baseline measurement obtained in Part 1.|Baseline and Week 130 (i.e., Week 26 of Part 2)|All randomized participants continuing to Part 2, with: 1) both a pre-dose baseline and ≥1 within-analysis-window, post-dose CDR-SB observation; 2) a positive test for cortical amyloid load by PET; and 3) a CDR-SB observation at week 130.|||Score on a Scale||Standard Deviation|Mean
2620668|NCT01953601|Primary|Part 1 (Base Study). Least Squares Mean (LSM) Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score at Week 104|LSM change from baseline at week 104 was assessed for CDR-SB score, a clinical rating of global cognitive function, comprised of 6 domains: memory; orientation; judgment and problem solving; community affairs; home and hobbies; and personal care. For each domain, the degree of impairment is assessed by a semi-structured interview of the participant as well as the participant's caregiver. For each domain, potential scores range from 0 (no impairment) to 3 (severe impairment). Individual domain scores are summed to a total CDR-SB score (range: 0-18). Higher scores indicate more severe cognitive impairment. Further, increases in cognitive impairment would be reflected by increases in CDR-SB score.|Baseline and Week 104 in Part 1|Includes all participants receiving ≥1 dose of study treatment in Part 1 who: 1) had both a pre-dose baseline and ≥1 within-analysis-window, post-dose CDR-SB observation; and 2) tested positive for cortical amyloid load by PET.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2620691|NCT01953328|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2620669|NCT01953575|Primary|Esophageal Mucosal Impedance (MI)|An endoscopically placed probe measured electrical impedance of the esophageal lining by direct mucosal contact. Impedance measurements of the esophageal mucosa were expressed in ohms as the ratio of voltage to current Impedance measurements were obtained at 2, 5, 10, and 15 cm above the gastroesophageal junction.|baseline to one year||||Ohms||Inter-Quartile Range|Mean
2620670|NCT01953432|Primary|Percentage of Cocaine-positive Urines|Over period of 12 weeks with 43 participants total (Doxazosin group = 22; Placebo group = 21), the overall percentage of cocaine positive urines per treatment group|Up to 12 weeks, or for the duration of the participant's involvement in the study|Study population was comprised of 43 cocaine-dependent individuals who met inclusion criteria for this study.|||percentage of cocaine-positive urines|||Number
2620671|NCT01953354|Secondary|Percent of Participants With Increase in Concurrent Ulcerative Colitis (UC) Medications or New Rescue Medications Added|New or increase in UC medications is defined as a need for dose-escalation of concurrent medications or need for rescue medications to treat UC through Week 16.|From Day 0 through Week 16|The Safety population included all subjects for whom study treatment was initiated.|||percentage of participants|||Number
2620672|NCT01953354|Secondary|Percent of Participants With Increase in Diarrhea|An increase in diarrhea is defined as an increase in the Mayo Score's Stool Frequency score by at least 1 point from baseline at any time during follow-up.|From Day 0 through end of follow-up, up to 36 weeks|The Safety population included all subjects for whom study treatment was initiated.|||percentage of participants|||Number
2620673|NCT01953354|Secondary|Percent of Participants With Colonoscopic Evidence of Visible Worm|Stool evaluations for ova and parasites confirmed the absence of T. suis. If evidence suggested a presence of T. suis, a colonoscopy would be performed to confirm invasion with a visible worm.|From Day 0 through end of follow-up, up to 36 weeks|The Safety population included all subjects for whom study treatment was initiated.|||percentage of participants|||Number
2620674|NCT01953354|Secondary|Time to Modified Clinical Response|Number of days to reach a modified clinical response. Modified clinical response is defined as a reduction in the modified Mayo score (i.e., minus the endoscopy component) of at least 2 points from baseline.|From Baseline through the day that modified clinical response is reached. Week 16 is the last visit that the modified Mayo score is assessed.|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects who achieved a modified clinical response are included in this analysis.|||Days||Full Range|Median
2620675|NCT01953354|Secondary|Percent of Participants With a Modified Clinical Response|Modified clinical response is defined as a reduction in the modified Mayo score (i.e., minus the endoscopy component) of at least 2 points from baseline.|From Day 0 through time of first clinical response or end of follow-up, whichever comes first, up to 12 Weeks|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects with baseline and at least one post-baseline modified clinical response result are included in this analysis.|||percentage of participants|||Number
2620676|NCT01953354|Secondary|Percent of Participants With Healed Colonic Mucosa at Week 12|Healed colonic mucosa is defined as a Mayo endoscopy score of 0 or 1.|Week 12|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects with a Mayo endoscopy score at Week 12 are included in this analysis.|||percentage of participants|||Number
2620677|NCT01953354|Secondary|Percent of Participants Who Achieved Remission at Week 12|Remission is defined as a Mayo score of less than or equal to 1 with absence of rectal bleeding and endoscopy score of 0 or 1.|Week 12|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects with remission results at Week 12 are included in this analysis.|||percentage of participants|||Number
2620678|NCT01953354|Primary|Percentage of Participants Who Achieved a Clinical Response at Week 12|Clinical response is defined as a reduction in the Mayo score of at least 3 points and at least a 30% reduction from Baseline, along with either a decrease from Baseline in the rectal bleeding subscore of more than 1 point or a rectal bleeding subscore of 0 or 1.|Week 12|The Modified Intent-to-Treat (mITT) population included all randomized subjects who received at least one dose of either TSO or placebo. Only mITT subjects with clinical response results at Week 12 are included in this analysis.|||percentage of participants|||Number
2620679|NCT01953328|Secondary|Percent Change From Baseline in VLDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2620680|NCT01953328|Secondary|Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2620681|NCT01953328|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2620682|NCT01953328|Secondary|Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2620683|NCT01953328|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2620684|NCT01953328|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2620685|NCT01953328|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2620686|NCT01953328|Secondary|Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2620687|NCT01953328|Secondary|Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12||Week 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2620688|NCT01953328|Secondary|Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL||Weeks 10 and 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2620689|NCT01953328|Secondary|Percent Change From Baseline in the Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2620709|NCT01953224|Secondary|Change in Motivation From Baseline to 12 Weeks|We will measure intrinsic motivation using the intrinsic regulation subscale from the Behavioral Regulation in Exercise Questionnaire-2. This measure uses a scale from 0 (not true for me) to 4 (very true for me). Positive changes indicate increases in intrinsic motivation over time. Baseline values were carried forward for participants lost to followup.|Baseline to 12 weeks|One participant did not provide usable data at baseline.|||units on a scale||Standard Deviation|Mean
2620710|NCT01953224|Secondary|Change in Weight From Baseline to 12 Weeks|We will measure weight using a calibrated scale. Baseline values were carried forward for participants lost to followup.|Baseline to 12 weeks||||pounds||Standard Deviation|Mean
2620711|NCT01953224|Secondary|Change in Blood Pressure From Baseline to 12 Weeks|Systolic and diastolic blood pressure will be measured using standard methods. Baseline values were carried forward for participants lost to followup.|Baseline to 12 weeks|Several participants did not provide usable data at baseline due to feasibility issues with our measurement protocols. Their data were not included here.|||mmHg||Standard Deviation|Mean
2620712|NCT01953224|Secondary|Change in Body Fat Percentage From Baseline to 12 Weeks|We will use dual x-ray absorptiometry to measure body fat percentage. Baseline values were carried forward for participants lost to followup.|Baseline to 12 weeks||||percent body fat||Standard Deviation|Mean
2620713|NCT01953224|Secondary|Change in Physical Fitness From Baseline to 12 Weeks|Maximal treadmill test to measure fitness (operationalized as the amount of oxygen used by the body during maximal effort). Baseline values were carried forward for participants lost to followup.|Baseline to 12 weeks|Several participants did not provide usable data at baseline due to feasibility issues with our measurement protocols. Their data were not included here.|||mL/kg/min||Standard Deviation|Mean
2620714|NCT01953224|Primary|Change in Physical Activity From Baseline to 12 Weeks|Minutes of physical activity measured over a 7 day period. Baseline values were carried forward for participants lost to followup.|Baseline to 12 weeks|Four participants' baseline data were found to be invalid based on standard protocols for accelerometer data cleaning/preparation (i.e., 4 days of 10+ hours wear time)|||minutes per day||Standard Deviation|Mean
2620715|NCT01953211|Primary|Follicle-stimulating Hormone|mean FSH on day 7 of the pill free interval|Serum blood samples were collected for hormone measurements at the same time daily during the 7 day hormone free interval.|Of note 1 person from the 20 and another from the 30 mcg EE groups hand significant loss of sample and poor processing due to limitations with processing and transport. As a result of this not all participants were able to contribute data for analysis|||milli international units per milliliter||Standard Deviation|Mean
2620716|NCT01953081|Secondary|Percentage of Gastric Retention by Scintigraphy at 240 Minutes Postdose|Mean gastric retention percentage after dosing.|240 minutes|ITT|||percentage of retention||Standard Deviation|Mean
2620717|NCT01953081|Secondary|Percentage Gastric Retention by Scintigraphy at 120 Minutes Postdose|Mean gastric retention percentage after dosing.|120 minutes|ITT|||percentage of retention||Standard Deviation|Mean
2620718|NCT01953081|Secondary|Percentage Gastric Retention by Scintigraphy at 60 Minutes Postdose|Mean gastric retention percentage after dosing.|60 minutes|ITT|||percentage of retention||Standard Deviation|Mean
2620719|NCT01953081|Secondary|Gastric Emptying by Breath Test|Time to 1/2 gastric emptying by breath test|180 minutes|One subject in the TD-8954 group did not receive the full dose of TD-8954 and was excluded from the TD-8954 analysis.|||minutes||Standard Deviation|Mean
2620720|NCT01953081|Secondary|Cmax|Maximum plasma concentration|72 hours|One subject did not receive the full dose of TD-8954 and was excluded from PK analysis for the TD-8954 group; Metoclopramide concentrations were not measured in the Metoclopramide group.|||pg/mL||Standard Deviation|Mean
2620721|NCT01953081|Secondary|AUC|Area under the plasma concentration time curve from 0 to 72 hours after dosing.|72 hours|One subject did not receive the full dose of TD-8954 and was excluded from PK analysis for the TD-8954 group; Metoclopramide concentrations were not measured in the Metoclopramide group.|||pg*hr/mL||Standard Deviation|Mean
2620722|NCT01953081|Secondary|Tmax|Time to maximal concentration in plasma|72 hours|PK Analysis set for subjects receiving TD-8954, metoclopramide concentrations were not measured in the metoclopramide group.|||hours||Full Range|Median
2620723|NCT01953081|Primary|Gastric Retention by Scintigraphy|Number of subjects with retention less than 13% at 180 minutes after dosing.|180 minutes|ITT|||participants|||Number
2620724|NCT01953081|Primary|Adverse Events|the number of subjects reporting adverse events by treatment group|6 Days|Safety Population|||participants|||Number
2620725|NCT01953003|Primary|Progression Free Survival (PFS)|The primary endpoint for the trial is progression-free survival calculated from the date of randomisation until the date of progression or the date of death whatever the cause of death. Patient who does not progressed will be censored at the date of last tumour assessment or the date of last contact of a follow-up showing no progression.|progression date will be assessed evey 6 weeks starting from the randomization date until first documented progression or date of death from any cause whichever came first assessed up to 3 years|The ITT population, comprised of all randomised patients|||Participants|||Count of Participants
2620726|NCT01952834|Secondary|Interleukin-12|This is a circulating plasma cytokine|Change before and after 6 weeks of probiotic|Subjects with plasma samples available pre and post probiotic supplementation|||pg/mL||Standard Error|Mean
2620727|NCT01952834|Secondary|Interleukin 8|Circulating cytokine measured in the plasma|Change before and after 6 weeks of daily Probiotic||||pg/mL||Standard Error|Mean
2620728|NCT01952834|Primary|Brachial Artery Flow Mediated Dilation|Flow Mediated Dilation is measured as the percent change in brachial artery diameter as measured by high resolution ultrasound based on arterial diameter prior to and following 5 minute flow occlusion to the forearm . We measured the percent change in brachial diameter before vancomycin was started and again 10 days after vancomycin|Change before and after 10 days of Vancomycin, approximately 12 weeks from baseline|Subgroup analyzed who volunteered to have vancomycin|||percent change||Standard Deviation|Mean
2620729|NCT01952834|Primary|Brachial Artery Flow Mediated Dilation|A measurement of endothelial function in humans that reports the percent change in brachial artery diameter to a flow stimulus in the arm induced by 5 minutes of occlusion of flow to the arm. It is measured as the percent change from baseline diameter.|% Change before and after 6 weeks of daily Probiotic||||percent change||Standard Deviation|Mean
2620731|NCT01952691|Secondary|FFI|We aimed to see the change in functional status with FFI (Foot function index) scale The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales used to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it required help) that best describes the patients' foot over the past week. Patients were instructed to mark a VAS score for each question. The total score was calculated using only the questions answered.|baseline, on the 3rd, 7th, 10th and 30th days during the treatment||||units on a scale|Participants|Standard Deviation|Mean
2620732|NCT01952691|Primary|Adduction Angle of Hallux With X RAY|X ray was obtained in non-weight bearing sitting position. It's aimed to see the treatment effects kinesio taping|up to 30 days after the treatment|35 feet's X Ray results were obtained from 22 patients before treatment protocol was performed.|||degrees|Participants|Standard Deviation|Mean
2620733|NCT01952678|Secondary|Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population|Overall percent agreement (OPA) regardless of image interpretation (analogous to accuracy; ratio of number of true results / number of all participants) for each racial group, was tested to determine if it was greater than 80% in both racial groups. The majority assessment was based on ≥2 of the 3 readers in agreement on the assessment.|Day 1|PP population consisted of all participants who met inclusion/exclusion criteria, had DaTscan™ image sets that were considered evaluable by ≥2 of the 3 blinded readers, and had no major protocol violations from any of the matched pair participants. Here, number of participants analyzed = participants with available data for this outcome measure.|||Overall percent agreement||95% Confidence Interval|Number
2620734|NCT01952678|Secondary|Overall Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population|Overall percent agreement (OPA) regardless of image interpretation (analogous to accuracy; ratio of number of true results / number of all participants) for each racial group, was tested to determine if it was greater than 80% in both racial groups. The majority assessment was based on ≥2 of the 3 readers in agreement on the assessment.|Day 1|The intent-to-diagnose (ITD) population that included all participants who underwent SPECT imaging after receiving DaTscan™ and enrolled in the study. Here, number of participants analyzed = participants with available data for this outcome measure.|||Overall percent agreement||95% Confidence Interval|Number
2620735|NCT01952678|Primary|Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population|The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the negative percent agreement (NPA, analogous to specificity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.|Day 1|PP population consisted of all participants who met inclusion/exclusion criteria, had DaTscan™ image sets that were considered evaluable by ≥2 of the 3 blinded readers, and had no major protocol violations from any of the matched pair participants. Here, number of participants analyzed = participants with available data for this outcome measure.|||Negative percent agreement||95% Confidence Interval|Number
2620736|NCT01952678|Primary|Negative Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population|The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the negative percent agreement (NPA, analogous to specificity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.|Day 1|ITD population that included all participants who underwent SPECT imaging after receiving DaTscan™ and enrolled in the study. Here, number of participants analyzed = participants with available data for this outcome measure.|||Negative percent agreement||95% Confidence Interval|Number
2620737|NCT01952678|Primary|Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Per Protocol (PP) Population|The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the positive percent agreement (PPA, analogous to sensitivity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.|Day 1|PP population consisted of all participants who met inclusion/exclusion criteria, had DaTscan™ image sets that were considered evaluable by ≥2 of the 3 blinded readers, and had no major protocol violations from any of the matched pair participants. Here, number of participants analyzed = participants with available data for this outcome measure.|||Positive percent agreement||95% Confidence Interval|Number
2620738|NCT01952678|Primary|Positive Percent Agreement of Blinded Visual Assessment of Each Participant's DaTscan Image - Intent-to-diagnose (ITD) Population|The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the positive percent agreement (PPA, analogous to sensitivity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.|Day 1|ITD population that included all participants who underwent SPECT imaging after receiving DaTscan™ and enrolled in the study. Here, number of participants analyzed = participants with available data for this outcome measure.|||Positive percent agreement||95% Confidence Interval|Number
2620739|NCT01952665|Primary|Lens Preference for Handling|Participant lens preference regarding handling. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).|4 weeks||||participants|||Number
2620740|NCT01952665|Primary|Lens Preference Comfort, Dryness, Vision and Overall.|Participant lens preference regarding comfort, dryness, vision and overall. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).|4 weeks||||participants|||Number
2620741|NCT01952665|Primary|Lens Preference|Participant lens preference in regard for comfort, dryness, handling, vision and overall. Collected at 4 weeks. (Forced Choice; Study Pair 1, Study Pair 2).|4 weeks||||participants|||Number
2620744|NCT01952665|Primary|Overall Satisfaction|Participant rating of satisfaction overall. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks||||participants|||Number
2620745|NCT01952665|Secondary|Likelihood to Continue Wearing the Study Lens|Participant likelihood of continuing wear of the study lense. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Very Likely, 2=Likely, 3=Unlikely, 4=Very Unlikely|4 weeks||||participants|||Number
2620746|NCT01952665|Secondary|Likelihood of Switching From Habitual Lens to Study Lens|Participant likelihood of switching from their habitual lens to the study lens. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=very likely, 2=likely, 3=unlikely, 4=very unlikely|4 weeks||||participants|||Number
2620747|NCT01952665|Secondary|Overall Fit Acceptance|Assessment of overall lens fit acceptance. Collected at 4 weeks. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)|4 Weeks||||lenses|lenses||Number
2620748|NCT01952665|Secondary|Push Up Test|Assessment of lens tightness. Collected at 4 weeks. Digital push up test. (Continuous Scale 0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)|4 Weeks||||units on a scale|lenses|Standard Deviation|Mean
2620749|NCT01952665|Secondary|Post Blink Movement|Assessment of post blink movement. Collected at 4 weeks. Assessed immediately after the blink. (Graded 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|4 Weeks||||units on a scale|lenses||Number
2620750|NCT01952665|Secondary|Corneal Coverage|Assessment of lens corneal coverage. Collected at 4 weeks. (Biomicroscopy; assessed in primary gaze, Normal Coverage or Not Covering)|4 Weeks||||lenses|lenses||Number
2620751|NCT01952665|Secondary|Centration|Assessment of lens centration. Collected at 4 weeks wear for both study lens pairs.. Biomicroscopy, by degree and direction in the primary position. (Optimal Centration or Not Optimal)|4 Weeks||||lenses|lenses||Number
2620752|NCT01952665|Secondary|Surface Deposition|Assessment of surface deposition by slit lamp. Collected at 4 weeks wear for both study lens pairs. (Grade 0-4 in 1/2 steps; 0=clean, 4=deposited)|4 Weeks||||units on a scale||Standard Deviation|Mean
2620753|NCT01952665|Secondary|Surface Wetting|Assessment of surface wetting by slit lamp. Collected at 4 weeks wear for both study lens pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)|4 Weeks||||units on a scale||Standard Deviation|Mean
2620754|NCT01952665|Secondary|Binocular Visual Acuity logMAR|Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart|4 Weeks||||logMAR||Standard Deviation|Mean
2620755|NCT01952665|Primary|Overall Vision Satisfaction|Participant rating of overall satisfaction for vision. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks||||participants|||Number
2620756|NCT01952665|Primary|Overall Handling Satisfaction|Participant rating of satisfaction regarding handling. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks||||participants|||Number
2620757|NCT01952665|Primary|Overall Dryness Satisfaction|Participant rating of satisfaction regarding dryness. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks||||participants|||Number
2620758|NCT01952665|Primary|Overall Comfort Satisfaction|Participant rating of satisfaction regarding comfort. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|4 weeks||||participants|||Number
2620759|NCT01952665|Primary|Overall Sensation of Smoothness|Participant rating of overall sensation for smoothness (deposit resistance). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.|4 weeks||||participants|||Number
2620760|NCT01952665|Primary|Overall Sensation of Moistness|Participant rating of overall sensation for moistness (hydration). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.|4 weeks||||participants|||Number
2620761|NCT01952665|Primary|Eye Whiteness/Redness|Participant rating for Eye Whiteness/Redness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Significant Redness, 10= Totally White)|4 weeks||||units on a scale||Standard Deviation|Mean
2620762|NCT01952665|Primary|Vision Satisfaction|Participant rating for vision satisfaction. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)|4 weeks||||units on a scale||Standard Deviation|Mean
2620763|NCT01952665|Primary|Handling|Participant rating for lens handling. Collected at 4 weeks. (0-10, 0= Very Difficult, 10= Very Easy).|4 weeks||||units on a scale||Standard Deviation|Mean
2620764|NCT01952665|Primary|Dryness|Participant rating for lens dryness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Dry, 10= No Dryness).|4 weeks||||units on a scale||Standard Deviation|Mean
2620765|NCT01952665|Primary|Comfort|Participant rating for lens comfort. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).|4 weeks||||units on a scale||Standard Deviation|Mean
2620766|NCT01952665|Primary|Rewetting Drops|Participant use of rewetting drops. Collected at 4 weeks wear for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).|4 weeks||||participants|||Number
2620767|NCT01952665|Primary|Average Daily Wearing Time|Participants measure of average daily wear time for study lenses at 4 weeks.|4 weeks||||hours||Standard Deviation|Mean
2620768|NCT01952665|Primary|Comfortable Wearing Time|Participant rating of lens Comfortable Wearing Time for both study pairs. Collected at 4 weeks wear. (The hours of average comfortable wearing time)|4 weeks||||hours||Standard Deviation|Mean
2620769|NCT01952665|Primary|Lens Preference, Pair 1 Lotrafilcon B|Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to lotrafilcon B as pair 1; Forced choice: Pair 1 or Habitual )|2 weeks||||participants|||Number
2620770|NCT01952665|Secondary|Overall Fit Acceptance|Assessment of overall lens fit acceptance. Collected at 2 weeks for both study pairs. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)|2 Weeks||||lenses|lenses||Number
2620771|NCT01952665|Secondary|Push Up Test|Assessment of lens tightness. Collected at 2 weeks for both study pairs. Digital push up test. (Continuous Scale 0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)|2 Weeks||||units on a scale|lenses|Standard Deviation|Mean
2620772|NCT01952665|Secondary|Post Blink Movement|Assessment of post blink movement. Collected at 2 weeks for both study lens pairs. Assessed immediately after the blink. (Graded 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|2 Weeks||||lenses|lenses||Number
2620773|NCT01952665|Secondary|Corneal Coverage|Assessment of lens corneal coverage. Collected at 2 weeks for both study pairs. Biomicroscopy; assessed in primary gaze. (Rated as Normal Coverage or Not Covering)|2 Weeks||||lenses|lenses||Number
2620774|NCT01952665|Secondary|Centration|Assessment of lens centration. Collected at 2 weeks. Biomicroscopy; by degree and direction in the primary position. Optimal versus not optimal|2 Weeks||||lenses|lenses||Number
2620775|NCT01952665|Secondary|Surface Deposition|Assessment of surface deposition by slit lamp. Collected at 2 weeks for both study lens pairs. (Grade 0-4 in 1/2 steps; 0=clean, 4=deposited)|2 Weeks||||units on a scale|eyes|Standard Deviation|Mean
2620776|NCT01952665|Secondary|Surface Wetting|Assessment of surface wetting by slit lamp. Collected at 2 weeks for both study lens pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)|2 Weeks||||units on a scale||Standard Deviation|Mean
2620777|NCT01952665|Secondary|Binocular Visual Acuity logMAR|Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart|2 Weeks||||logMAR||Standard Deviation|Mean
2620778|NCT01952665|Primary|Lens Preference, Pair 1 Comfilcon A|Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to comfilcon A as pair 1; Forced choice: Pair 1 or Habitual)|2 weeks||||participants|||Number
2620779|NCT01952665|Primary|Overall Satisfaction|Participant rating of satisfaction overall. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks||||participants|||Number
2620780|NCT01952665|Primary|Overall Vision Satisfaction|Participant rating of satisfaction regarding vision. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks||||participants|||Number
2620781|NCT01952665|Primary|Overall Handling Satisfaction|Participant rating of satisfaction regarding handling. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks||||participants|||Number
2620782|NCT01952665|Primary|Overall Dryness Satisfaction|Participant rating of satisfaction regarding dryness. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks||||participants|||Number
2620783|NCT01952665|Primary|Overall Comfort Satisfaction|Participant rating of satisfaction regarding comfort. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied|2 weeks||||participants|||Number
2620784|NCT01952665|Primary|Overall Sensation of Smoothness|Participant rating of overall sensation for smoothness (deposit resistance). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.|2 weeks||||participants|||Number
2620785|NCT01952665|Primary|Overall Sensation of Moistness|Participant rating of overall sensation for moistness (hydration). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.|2 weeks||||participants|||Number
2620786|NCT01952665|Primary|Eye Whiteness/Redness|Participant rating for Eye Whiteness/Redness. After 2 weeks wear for each study pair. (0-10, 0= Significant Redness, 10= Totally White)|2 weeks||||units on a scale||Standard Deviation|Mean
2620787|NCT01952665|Primary|Vision Satisfaction|Participant rating for vision satisfaction. After 2 weeks wear for each study pair. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)|2 weeks||||units on a scale||Standard Deviation|Mean
2620788|NCT01952665|Primary|Handling|Participant rating for lens handling. After 2 weeks wear for each study pair. (0-10, 0= Very Difficult, 10= Very Easy).|2 weeks||||units on a scale||Standard Deviation|Mean
2620789|NCT01952665|Primary|Dryness|Participant rating for lens dryness. After 2 weeks wear for each study pair. (0-10, 0= Very Dry, 10= No Dryness).|2 weeks||||units on a scale||Standard Deviation|Mean
2620790|NCT01952665|Primary|Comfort|Participant rating for lens comfort. After 2 weeks wear for each study pair. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).|2 weeks||||units on a scale||Standard Deviation|Mean
2620791|NCT01952665|Primary|Comfortable Wearing Time|Participant rating of lens Comfortable Wearing Time for both study pairs. After 2 weeks wear for each pair. (The hours of average comfortable wearing time)|2 weeks||||hours||Standard Deviation|Mean
2620792|NCT01952665|Secondary|Rewetting Drops|Participant use of rewetting drops. Collected at 2 weeks for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).|2 weeks||||participants|||Number
2620793|NCT01952665|Primary|Average Daily Wearing Time|Participants measure of average daily wear time for study lenses at 2 Weeks.|2 weeks||||hours||Standard Deviation|Mean
2620794|NCT01952665|Other Pre-specified|The Number of Trials Needed to Achieve Final Dispensing Pair of Study Lenses.|The number of trials needed to achieve final dispensing pair of study lenses. Number of lenses required to dispense the final pair of study lenses. Collected at dispense for both study lens pairs. (Number required; 1, 2, 3, >3)|Dispense||||number of trial lenses|lenses|Standard Deviation|Mean
2620795|NCT01952665|Secondary|Overall Fit Acceptance|Assessment of overall lens fit acceptance. Collected at dispense for both study pairs. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but okay to dispense, 4=perfect)|Dispense||||units on a scale|lenses|Standard Deviation|Mean
2620796|NCT01952665|Secondary|Push Up Test|Assessment of lens tightness. Collected at dispense for both study pairs. Digital push up test. Continuous Scale (0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)|Dispense||||units on a scale|lenses|Standard Deviation|Mean
2620797|NCT01952665|Secondary|Post Blink Movement|Assessment of post blink movement. Collected at dispense for both study lens pairs. Assessed immediately after the blink. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)|Dispense||||lenses|lenses||Number
2620798|NCT01952665|Secondary|Corneal Coverage|Assessment of lens corneal coverage. Collected at dispense for both study pairs. Biomicroscopy; assessed in primary gaze. (Rated as Normal Coverage or Not Covering)|Dispense||||lenses|lenses||Number
2620799|NCT01952665|Secondary|Centration|Assessment of lens centration. Collected at dispense for both study pairs. Biomicroscopy; by degree and direction in the primary position. (Rated as Optimal Centration or Not Optimal)|Dispense||||lenses|lenses||Number
2620800|NCT01952665|Secondary|Surface Deposition|Assessment of surface deposition by slit lamp. Collected at dispense for both study pairs. (Grade 0-4 in ½ steps; Clean= 0; Deposited = 4)|Dispense||||units on a scale|eyes|Standard Deviation|Mean
2620801|NCT01952665|Secondary|Surface Wetting|Assessment of surface wetting by slit lamp. Collected at dispense for both study pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)|Dispense||||units on a scale|eyes|Standard Deviation|Mean
2620802|NCT01952665|Secondary|Binocular Visual Acuity logMAR|Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart|Dispense||||logMAR||Standard Deviation|Mean
2620803|NCT01952665|Primary|Visual Quality|Participant rating of visual quality. Collected at dispense for both study pairs. (0-10, 0= Very Poor Vision, 10= Perfectly Sharp, Clear Vision)|Dispense||||units on a scale||Standard Deviation|Mean
2620804|NCT01952665|Primary|Comfort at Insertion|Participant rating for lens comfort on insertion. Collected at dispense for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot feel).|Dispense||||units on a scale||Standard Deviation|Mean
2620805|NCT01952600|Primary|Factors That Are Most Important to Patients|Differences in factors most important to patients were compared across chronic kidney disease, hemodialysis, and peritoneal dialysis patients.|Baseline||||% of patients|||Number
2620806|NCT01952574|Secondary|Change From Baseline in Monthly Migraine Attacks at Week 12|"A migraine attack is an episode of any qualified migraine headache or migraine specific medication intakes for aura only. A migraine attack that was interrupted by sleep or that temporarily remits and then recurs within 48 hours or an attack treated successfully with medication but that relapses within 48 hours was considered to be one attack.~The change from baseline in monthly migraine attacks was calculated as the number of migraine attacks during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine attacks during the 4-week baseline phase."|4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase|Participants who received at least 1 dose of investigational product and had ≥ 4 migraine days during the 4-week baseline phase (efficacy analysis set), and with at least one change from baseline value in monthly migraine attacks.|||migraine attacks/month||Standard Error|Least Squares Mean
2620807|NCT01952574|Secondary|Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Week 12|A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine without aura or a migraine with aura. Monthly migraine days were calculated as the number of migraine days in the 4-week baseline phase and during the last 4 weeks of double-blind treatment. At least a 50% reduction from baseline in monthly migraine days was determined if the change in monthly migraine days from the 4-week baseline phase to the last 4 weeks of the 12-week double-blind treatment phase * 100 / baseline monthly migraine days was less than or equal to -50%.|4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase|Participants who received at least 1 dose of investigational product and had ≥ 4 migraine days during the 4-week baseline phase (efficacy analysis set) with available data at week 12.|||percentage of participants|||Number
2620808|NCT01952574|Primary|Change From Baseline in Monthly Migraine Days at Week 12|A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura. The change from baseline in monthly migraine days was calculated as the number of migraine days during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine days during the 4-week baseline phase.|4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase|Participants who received at least 1 dose of investigational product and had ≥ 4 migraine days during the 4-week baseline phase (efficacy analysis set), and with at least one change from baseline value in monthly migraine days.|||migraine days / month||Standard Error|Least Squares Mean
2620809|NCT01952470|Secondary|BronkoTest (Sputum Colour) - Purulent Sputum Days|Sputum colour chart. Sputum colour has been shown to correlate with physiological infection in other chronic lung disease groups(22).|Daily up to 3 months.|Dropout / loss of data.|||days||Inter-Quartile Range|Median
2620838|NCT01952418|Primary|Adenoma Detection Rate (All Indications)|Number of patients with adenoma detected|within 2 weeks (range of 1 day-14 days) of the endoscopy|all indications|||Participants|||Count of Participants
2620810|NCT01952470|Secondary|Breathlessness, Cough and Sputum Scale (BCSS) - Exacerbations|"Self-reported symptom severity, used as a daily patient diary. The BCSS is a 12 point self-reported symptom severity score, consisting of 3 sections concerning how much difficulty the subject is having with breathing; subjective cough symptoms and trouble caused by sputum, each scoring between 0-4, combining to a total score of 0-12 (higher=worse). This scale is validated for daily use in Chronic Obstructive Pulmonary Disease (COPD)(21).~An exacerbation was defined as an increase in BCSS>1 with ≥5 days preceding stability."|Daily up to 3 months.||||Exacerbations||Standard Deviation|Mean
2620811|NCT01952470|Secondary|C-reactive Protein (CRP)|An inflammatory marker measured with routine blood tests on admission with LRTI. Taken during inpatient (IP) stay and routinely on outpatient (OP) follow-up. Existing / available data only will be used - no extra routine bloods will be taken on account of study inclusion.|1 month, 3 months.|Data only available when routinely collected.|||mg/L (change)||Inter-Quartile Range|Median
2620812|NCT01952470|Secondary|Number of Hospitalizations|Number of admissions to the acute setting.|Over study period (3 months).||||Hospitalizations|||Number
2620813|NCT01952470|Secondary|Oral, Inhaled or Intravenous Antibiotic (IVAB) Days.|Antibiotic use for the treatment of lower respiratory tract infections (LRTI) only.|Over study period (3 months).||||Days||Inter-Quartile Range|Median
2620814|NCT01952470|Secondary|Inpatient Days|Number of days spent in the acute inpatient setting.|Across study period (3 months).||||Days||Standard Deviation|Mean
2620815|NCT01952470|Secondary|St. George's Respiratory Questionnaire (SGRQ) - Change|"The SGRQ is a 2-part questionnaire, validated in chronic lung disease other than lung transplant(20).~50 items, 76 weighted responses. Scores range 0-100, higher=worse."|1 month, 3 months.|Dropout / lost data.|||units on a scale||Standard Deviation|Mean
2620816|NCT01952470|Secondary|Leicester Cough Questionnaire (LCQ) - Change|Cough specific quality of life questionnaire. The LCQ is a 19-question tool, validated in chronic lung disease other than lung transplant(19). Scale 1-7 for physical, psychological, social. Combined score of 3-21 for total. Lower=worse.|1 month, 3 months.|Dropout / loss of data.|||score on a scale||Standard Deviation|Mean
2620817|NCT01952470|Secondary|Forced Expiratory Ratio (FER)|FER represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC).|1 month, 3 months|Dropout|||Ratio||Standard Deviation|Mean
2620818|NCT01952470|Secondary|Forced Vital Capacity (FVC) Percent|Forced vital Capacity (FVC) is a measure of the amount of air someone can forcibly expel out of the lungs after taking a breath to fill the lungs as much as possible.|1 month, 3 months|Dropout|||Percent (%)||Standard Deviation|Mean
2620819|NCT01952470|Secondary|Forced Vital Capacity (FVC) Liters|Forced vital Capacity (FVC) is a measure of the amount of air someone can forcibly expel out of the lungs after taking a breath to fill the lungs as much as possible.|1 month, 3 months|Dropout|||Liters (L)||Standard Deviation|Mean
2620820|NCT01952470|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Percent.|FEV1 is the maximal amount of air you can forcefully exhale in one second.|1 month, 3 months|Dropout|||Percent (%)||Standard Deviation|Mean
2620821|NCT01952470|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Liters|FEV1 is the maximal amount of air you can forcefully exhale in one second.|1 month, 3 months.|Dropout|||Liters (L) - change||Standard Deviation|Mean
2620822|NCT01952470|Secondary|Functional Residual Capacity (FRC)|Volume of air remaining in the lungs after normal expiration.|1 month, 3 months|Dropout|||Liters (L)||Standard Deviation|Mean
2620823|NCT01952470|Secondary|Multiple Breath Washout (MBW)|"Multiple breath washout is a sensitive measure of respiratory function performed with the subject in a seated position, breathing a fixed tidal volume (1L) of inert gas (nitrogen) from functional residual capacity (FRC) via mouthpiece.~Two common outcomes of MBW are Sacin, a measure of gas mixing at the diffusion front, or acinar entrance in the airways, and Scond, in the proximal, conductive zones. An increase in either Sacin or Scond represents an increase in ventilation heterogeneity (deterioration). Both increase with age, normal values are non-zero between 0-0.25(Sacin) and 0-0.1(Scond)."|1 month, 3 months|Dropout|||Gas mixing index (Sacin / Scond)||Standard Deviation|Mean
2620824|NCT01952470|Primary|Lung Clearance Index 2% (LCI2%)|"A measure of ventilation inhomogeneity as measured during multiple breath washout (MBW) of inert tracer gases. It has been shown that this test is a potentially more sensitive measure of peripheral airway obstruction than regular spirometry in short term (4 week) mucolytic interventional studies in pediatric Cystic Fibrosis (CF)(17-18). This test would be performed within the respiratory physiology lung function laboratory on site at all assessment points, by an assessor who is blinded to group allocation for follow up data collection.~Conventionally used primary endpoints in this population, such as regular spirometry(3), may be unable to detect between group differences without large sample sizes and long treatment durations. Based on current evidence from non-lung transplant populations, LCI has been able to show short-term change, whereas regular spirometry has not shown change(17-18)."|1 month, 3 months|Dropout|||Index (change)||Standard Deviation|Mean
2620825|NCT01952444|Secondary|Number of Participants With Anti-ETI-204 Antibodies|Serum anti-ETI-204 antibody titers were determined for all subjects in the Safety Population. Blood samples were collected and serum samples were assayed at an initial dilution of 1:10. Samples that were positive at the 1:10 dilution were serially diluted 1:2 and assayed until a negative result was attained. The titer of the most dilute sample yielding a positive result was recorded as the titer for that time point. Immunogenicity was measured by the number of participants in each study arm with anti-ETI-204 antibody values post-treatment ≥ 4-times higher than baseline at Day 8, 43 or 71, or if the titer was negative at baseline, the post-treatment sample(s) required a titer of at least 1:20 for it to be considered positive.|On Day 1 at predose and on Days 9, 29, 43, and 71.|All subjects who received ETI-204 and were included in the Safety Population.|||Participants|||Count of Participants
2620839|NCT01952366|Secondary|Number of Patients With a Diagnosis of Dementia|One year after inclusion to the study, there will be a clinical assessment of the patient including a MMSE, if possible, and to evaluate if the patients have dementia.|1 year after inclusion to the study||||Participants|||Count of Participants
2620840|NCT01952366|Primary|Depression|Relapse/recurrence of depression|1 year after inclusion to the study|Inpatients|||participants|||Number
2624507|NCT01923480|Secondary|Plasma Concentration of Histidine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
2620826|NCT01952444|Secondary|Volume of Distribution at Steady State (Vss)|Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|On Day 1 at predose, at the end of ETI-204 infusion, 2.5, 4.5 and 7.5 hours after the start of the ETI-204 infusion, and on Days 2 (24 hours), 9, 16, 29, 43, and 71.|All subjects for whom Cmax, Tmax and AUC0-last were calculated minus 2 subjects (1 in the ETI-204 group and 1 in the ETI-204 + ciprofloxacin group) whose t1/2 values were > than 50% of the total sample collection interval. AUC0-inf and AUC0-inf-based parameters were not reported for those subjects in accordance with the statistical analysis plan.|||Liters||Standard Deviation|Mean
2620827|NCT01952444|Secondary|Volume of Distribution (Vd)|Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|On Day 1 at predose, at the end of ETI-204 infusion, 2.5, 4.5 and 7.5 hours after the start of the ETI-204 infusion, and on Days 2 (24 hours), 9, 16, 29, 43, and 71.|All subjects for whom Cmax, Tmax and AUC0-last were calculated minus 2 subjects (1 in the ETI-204 group and 1 in the ETI-204 + ciprofloxacin group) whose t1/2 values were > than 50% of the total sample collection interval. AUC0-inf and AUC0-inf-based parameters were not reported for those subjects in accordance with the statistical analysis plan.|||Liters||Standard Deviation|Mean
2620828|NCT01952444|Secondary|Systemic Clearance (CL)|Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|On Day 1 at predose, at the end of ETI-204 infusion, 2.5, 4.5 and 7.5 hours after the start of the ETI-204 infusion, and on Days 2 (24 hours), 9, 16, 29, 43, and 71.|All subjects for whom Cmax, Tmax and AUC0-last were calculated minus 2 subjects (1 in the ETI-204 group and 1 in the ETI-204 + ciprofloxacin group) whose t1/2 values were > than 50% of the total sample collection interval. AUC0-inf and AUC0-inf-based parameters were not reported for those subjects in accordance with the statistical analysis plan.|||Liters/day||Standard Deviation|Mean
2620829|NCT01952444|Secondary|Terminal Half-life (t1/2)|Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|On Day 1 at predose, at the end of ETI-204 infusion, 2.5, 4.5 and 7.5 hours after the start of the ETI-204 infusion, and on Days 2 (24 hours), 9, 16, 29, 43, and 71.|All subjects for whom Cmax, Tmax and AUC0-last were calculated minus 2 subjects (1 in the ETI-204 group and 1 in the ETI-204 + ciprofloxacin group) whose t1/2 values were > than 50% of the total sample collection interval. AUC0-inf and AUC0-inf-based parameters were not reported for those subjects in accordance with the statistical analysis plan.|||days||Standard Deviation|Mean
2620830|NCT01952444|Secondary|Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf)|Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|On Day 1 at predose, at the end of ETI-204 infusion, 2.5, 4.5 and 7.5 hours after the start of the ETI-204 infusion, and on Days 2 (24 hours), 9, 16, 29, 43, and 71.|All subjects for whom Cmax, Tmax and AUC0-last were calculated minus 2 subjects (1 in the ETI-204 group and 1 in the ETI-204 + ciprofloxacin group) whose t1/2 values were > than 50% of the total sample collection interval. AUC0-inf and AUC0-inf-based parameters were not reported for those subjects in accordance with the statistical analysis plan.|||µg.day/mL||Standard Deviation|Mean
2620831|NCT01952444|Secondary|Area Under the Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUC0-last))|Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|On Day 1 at predose, at the end of ETI-204 infusion, 2.5, 4.5 and 7.5 hours after the start of the ETI-204 infusion, and on Days 2 (24 hours), 9, 16, 29, 43, and 71.|All subjects who received ETI-204 and had at least one valid PK parameter were included in the PK Population: Two subjects who received a partial dose of ETI-204 due to AEs and 1 who withdrew prematurely on Day 1 for personal reasons after the IV infusions of ETI-204 and ciprofloxacin were excluded from the ETI-204 + ciprofloxacin group.|||µg.day/mL||Standard Deviation|Mean
2620832|NCT01952444|Secondary|Time to Maximum Observed Plasma Concentration of ETI-204 (Tmax)|Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|On Day 1 at predose, at the end of ETI-204 infusion, 2.5, 4.5 and 7.5 hours after the start of the ETI-204 infusion, and on Days 2 (24 hours), 9, 16, 29, 43, and 71.|The PK Population consisted of all subjects who received ETI-204 and had at least one valid PK parameter. Two subjects in the ETI-204 + ciprofloxacin group received partial doses of ETI-204 (discontinued study drug due to AEs) and were excluded from the PK Population.|||days||Full Range|Median
2620833|NCT01952444|Secondary|Maximum Observed Plasma Concentration of ETI-204 (Cmax)|Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|On Day 1 at predose, at the end of ETI-204 infusion, 2.5, 4.5 and 7.5 hours after the start of the ETI-204 infusion, and on Days 2 (24 hours), 9, 16, 29, 43, and 71.|The Pharmacokinetic (PK) Population consisted of all subjects who received ETI-204 and had at least one valid PK parameter. Two subjects in the ETI-204 + ciprofloxacin group received partial doses of ETI-204 (discontinued study drug due to AEs) and were excluded from the PK Population.|||µg/mL||Standard Deviation|Mean
2620834|NCT01952444|Primary|Number of Participants Who Experienced Adverse Events|Safety was assessed for all subjects in the Safety Population by collecting and monitoring vital signs, clinical laboratory tests, ECGs, physical assessments, skin assessments, infusion site assessments, and adverse events (AEs).|Up to 71 days or 101 days (30 days after the final study visit) for subjects with ongoing adverse events at the final study visit, for each group.|All randomized subjects who received study drug were included in the Safety Population.|||Participants|||Count of Participants
2620835|NCT01952418|Secondary|Polyp Detection Rate (Screening Exams Only)|Number of patients with polyps detected|recorded during endoscopy (immediate)|screening exams only|||Participants|||Count of Participants
2620836|NCT01952418|Secondary|Polyp Detection Rate (All Indications)|Number of patients with polyps detected|recorded during endoscopy (immediate)|all indications|||Participants|||Count of Participants
2620837|NCT01952418|Primary|Adenoma Detection Rate (Screening Exams Only)|Number of patients with adenoma detected|within 2 weeks (range of 1 day-14 days) of the endoscopy|screening exams only|||Participants|||Count of Participants
2620841|NCT01952366|Primary|Depression|"Response (50% improvement on the Montgomery and Asberg Depression Rating Scale (MADRS) score) Remission (defined as score of 9 or less on the MADRS)~The MADRS is a measurement of the severity of depression and consists of 10 items rated from 0 points (no symptoms) to 6 (severe symptoms)"|Patients were follow during their stay in the hospital; average days of stay in hospital = 68.3 (SD=46.8)|Patients with complete MADRS records|||participants|||Number
2620842|NCT01952301|Primary|Keratinized Tissue Width|Change in Keratinized Tissue width|6 months|Sample size was determined using 80% power fans assuming a paired t-test of non-inferiority with a non-inferiority margin of 1.0 mm, a within-subject standard deviation of 1.0 mm, and a one-sided alpha of 0.05, resulting in a sample size of 27. To account for potential loss-to-follow-up, 30 subjects were enrolled in the trial.|||mm||Standard Deviation|Mean
2620843|NCT01952145|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes were defined as either: Severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or an episode biochemically confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia.|During 26 weeks of treatment|The safety analysis set was used for analysis of this endpoint and this set included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation “as treated”. Confirmed hypoglycaemic episodes were reported by 79 subjects in IdegLira arm and by 137 subjects in IGlar arm.|||Number of episodes|||Number
2620844|NCT01952145|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight after 26 weeks of treatment|Week 0, week 26|FAS which included all randomised subjects was used for analysis of this endpoint. Missing values (including intermittent missing values) were imputed using LOCF method.|||Kg||Standard Deviation|Mean
2620845|NCT01952145|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, week 26|FAS was used for analysis of this endpoint. And FAS included all randomised subjects. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method.|||Percentage (%)||Standard Deviation|Mean
2620846|NCT01952080|Primary|Absolute Change in Parenteral Support (PN/IV) Volume at Week 16|Absolute change in PN/IV from the Baseline Visit to Week 16 Visit.|Baseline, Week 16|Absolute change in PN/IV volume from baseline to Week 16 based on prescribed data - Intent-to-Treat Population|||Liters/week||Standard Deviation|Mean
2620847|NCT01952080|Primary|Absolute Change in Parenteral Support (PN/IV) Volume at End of Treatment|Absolute change in PN/IV from the Baseline Visit to End of Treatment Visit.|Baseline, End of Treatment|Absolute change in PN/IV volume from baseline to End of Treatment based on prescribed data - Intent-to-Treat Population|||Liters/week||Standard Deviation|Mean
2620848|NCT01952080|Other Pre-specified|Absolute Change in Enteral Support (EN) Volume From Baseline at Week 16|Absolute change in enteral support requirements at Week 16 (liters/week)|Baseline, Week 16|Absolute change of EN volume from baseline to Week 16 based on subject diary data - Intent-to-Treat Population|||Liters/week||Standard Deviation|Mean
2620849|NCT01952080|Other Pre-specified|Absolute Change in Enteral Support (EN) Volume From Baseline at Week 12|Absolute change in enteral support requirements at Week 12 (liters/week)|Baseline, Week 12|Absolute change of EN volume from baseline to Week 12 based on subject diary data - Intent-to-Treat Population|||Liters/week||Standard Deviation|Mean
2620850|NCT01952080|Other Pre-specified|Percent Change in Enteral Support (EN) Volume From Baseline at Week 16|Percent change in enteral support requirements at Week 16 (liters/week)|Baseline, Week 16|Percent change of EN volume from baseline to Week 16 based on subject diary data - Intent-to-Treat Population|||percent change||Standard Deviation|Mean
2620851|NCT01952080|Other Pre-specified|Percent Change in Enteral Support (EN) Volume From Baseline at Week 12|Percent change in enteral support requirements at Week 12 (liters/week)|Baseline, Week 12|Percent change of EN volume from baseline to Week 12 based on subject diary data - Intent-to-Treat Population|||percent change||Standard Deviation|Mean
2620852|NCT01952080|Primary|Absolute Change in Parenteral Support (PN/IV) Volume at Week 12|Absolute change in PN/IV from the Baseline Visit to Week 12 Visit.|Baseline, Week 12|Absolute change in PN/IV volume from baseline to Week 12 based on prescribed data - Intent-to-Treat Population|||Liters/week||Standard Deviation|Mean
2620853|NCT01952080|Primary|Percent Change in Parenteral Support (PN/IV) Volume at Week 16|Percent change in PN/IV from the Baseline Visit to Week 16 Visit.|Baseline, Week 16|Percent change in PN/IV volume from baseline to Week 16 based on prescribed data - Intent-to-Treat Population|||percent change||Standard Deviation|Mean
2620854|NCT01952080|Primary|Percent Change in Parenteral Support (PN/IV) Volume at End of Treatment|Percent change in PN/IV from the Baseline Visit to End of Treatment Visit.|Baseline, End of Treatment|Percent change in PN/IV volume from baseline to End of Treatment based on prescribed data - Intent-to-Treat Population|||percent change||Standard Deviation|Mean
2620855|NCT01952080|Primary|Percent Change in Parenteral Support [Parenteral Nutrition (PN)/Intravenous (IV)] Volume at Week 12|Percent change in PN/IV from the Baseline Visit to Week 12 Visit.|Baseline, Week 12|Percent change in PN/IV volume from baseline to Week 12 based on prescribed data - Intent-to-Treat Population (ITT), defined as all participants who were enrolled in the study.|||percent change||Standard Deviation|Mean
2620856|NCT01952054|Secondary|The Changes in Urine N-telopeptide Level|The collection urine is performed at baseline, at week4 and the end of 3rd cycle (week13) to evaluate the level of N-telopeptide.|Baseline up to week 13||||nmol/mmol||Standard Deviation|Mean
2620857|NCT01952054|Secondary|The Changes of Epithelial-mesenchymal Transition (EMT) in CTCs|The change in Her2, Muc-1, GA733-2 (EpCAM), Twist, Akt, PI3K and ALDH-1 in CTCs after 1 st cycle of treatment with denosumab.|Baseline, week 4||||ng/uL||Standard Deviation|Mean
2620858|NCT01952054|Primary|The Effect of Denosumab in Reducing Circulating Tumor Cells (CTCs) Among Breast Cancer Patients With Bone Metastases.|The difference in number of CTCs in 7.5 ml whole blood from baseline to week4. CTC reduction from baseline to week4 is statistically analyzed using the two-sided paired t-test with the significance level of 0.05.|Baseline, week 4|The primary objective could not be met due to technical issues.||||||
2621038|NCT01950299|Primary|Acute Phase Response (CRP Levels)|Comparison of area-under-the-curve for CRP up to day 14|14 days||||mg x day/L (milligram x day/liter)||Inter-Quartile Range|Median
2620859|NCT01952041|Secondary|Social Functioning|Social Functioning was assessed using the Social Functioning Scale (SFS). This is a 76-item questionnaire that assesses various aspects of social functioning and generates a number of subscale scores including social withdrawal, interpersonal behavior, pro-social activities, and an overall score of social functioning. The item values range from 0 (almost never) to 3 (often). Total scores range from 0-228. A higher score indicates greater social functioning.|Assessed at baseline and every three months for one year.||||score on a scale||Standard Deviation|Mean
2620860|NCT01952041|Secondary|Depression|Depression measured using the Calgary Depression Scales (CDSS). This is a 9-item assessment with values of 0 (absent) to 3 (severe) of depressive symptoms separate from positive, negative and extrapyramidal symptoms in people with schizophrenia. Total scores range from 0-27. A higher score indicates more severe symptoms.|Assessed at baseline and every three months for one year.||||score on a scale||Standard Deviation|Mean
2620861|NCT01952041|Secondary|Psychotic Symptom Severity|Psychotic symptom severity assessed using the Brief Psychiatric Rating Scale (BPRS). This is an 18-item scale that rates severity of positive symptoms (including auditory hallucinations and persecutory ideation), and mood and behavioral symptoms. Items are rated by a clinical assessor on a scale of 1 (absent) to 7 (very severe). Total scores range from 18-126. Higher scores indicate worse symptoms.|Assessed at baseline and every three months for one year.||||score on a scale||Standard Deviation|Mean
2620862|NCT01952041|Primary|Time to Relapse|Time to first relapse was defined as the time from randomization until the first relapse. Participants who did not experience a relapse were censored at their last known time relapse-free. Time-to-first relapse was estimated using the Kaplan-Meier method.|From randomization date until first relapse (evaluated approximately every 3 months until their last study visit which occurred approximately 12 months from randomization for those who completed the study).||||months||95% Confidence Interval|Median
2620863|NCT01952041|Primary|Relapses in Participants|A count of participants who experienced relapse, as defined as one of the following events: psychiatric hospitalization, a significant increase in the level of psychiatric care (i.e. frequency and intensity of services), an increase in medication in addition to a 25% increase in Brief Psychiatric Rating Scale (BPRS) from last assessment, suicidal or homicidal ideation that was clinically significant in the investigator's judgement, deliberate self-injury, violent behavior resulting in damage to another person or property.|1 year||||Participants|||Count of Participants
2620864|NCT01952015|Secondary|Number of Patients With GPP-related Systemic and Topical Co-medication Over Time|Use of systemic and topical co-medication to treat generalized pustular psoriasis (GPP), in subjects who have active GPP treatment at baseline.|up to week 52|Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.|||Participants|||Number
2620865|NCT01952015|Secondary|Mean Health-related Quality of Life (The Dermatology Life Quality Index [DLQI] and Short Form Health Survey [SF-36]) Over Time|DLQI is a 10-item general dermatology disability index designed to assess HRQL in adults with skin diseases (Finlay & Khan 94). The measure is self-admin. & includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. DLQI total score is the sum of the 10 questions. Each item has four response categories, ranging from 0 (not at all) to 3 (very much). Scores range from 0 to 30 9higher scores indicate greater health-related quality of-life impairment). SF-36 is a widely used and extensively studied instrument to measure HRQL among healthy subjects with acute & chronic conditions (Ware et al. 93, 94). It consists of 8 subscales (based on a scale of 0-100) that can be scored individually: Two overall summary scores for SF-36, the Physical Component Summary (PCS) and the Mental Component Summary (MCS), were computed. DLQI total score decreases and SF-36 increases with improvement of quality of life.|Up to week 148 (end of treatment)|Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.|||scores on a scale||Standard Deviation|Mean
2620866|NCT01952015|Secondary|Change From Baseline in Observed Value of Components of the JDA Severity Index for GPP|"The observed value for the following components of the JDA severity index for GPP were reported: percentage of body surface area covered with erythema with pustules, percentage of body surface area covered with total erythema, percentage of body surface area covered with edema, fever (body temperature,°C), white blood cell (WBC) count (/μL), C-reactive protein (mg/L), serum albumin (g/dL).~Percent change=100 x Absolute change/post baseline."|up to week 148 (end of trial)|Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.|||Percent change||Standard Deviation|Mean
2620867|NCT01952015|Secondary|The Japanese Dermatological Association (JDA) Component Score for GPP Over Time|"The following components of the JDA severity index for generalized pustular psoriasis (GPP) were reported: body surface area (SA)covered with total erythema with pustules, body SA covered with total erythema, body SA covered with edema, fever, white blood cell (WBC) count, C-reactive protein, serum albumin.~The total score of JDA severity index was assigned a score of 0-17. Assessment of skin lesions: area of erythema with pustules, area of erythema, and area of edema; each score 0-3. Assessment of systemic manifestations and laboratory findings: fever, WBC count, CRP and serum albumin; each score 0-2.~The higher the JDA severity index for GPP score the worse the outcome."|up to week 148 (end of trial)|Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.|||mean scores on a scale||Standard Deviation|Mean
2620868|NCT01952015|Secondary|Summary of JDA Total Score Category for GPP by Visit up to End of Trial|Japanese dermatological association (JDA) severity index for generalized pustular psoriasis (GPP) included 3 categories (mild, moderate, and severe) in the severity index.|up to week 148 (End of Trial)|Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.|||Participants|||Number
2620869|NCT01952015|Secondary|Summary of Clinical Global Impression up to End of Trial|"Clinical Global Impression (CGI) has five categories: Very much improved, much improved, minimally improved, no change and worsened.~Two patients did not achieve treatment success at week 52 with CGI evaluated as missing and both were imputed as no treatment success."|up to week 148 (End of Trial)|Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.|||Participants|||Number
2620870|NCT01952015|Secondary|Number of Patients With Treatment Success at End of Trial Using Non-responder Imputation (Full Analysis Set)|"Clinical global impression (CGI) evaluated as very much improved, much improved, Minimally improved."|week 148|Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.|||Participants|||Number
2620871|NCT01952015|Secondary|Number of Patients With Treatment Success at Week 52 Using Non-responder Imputation (Full Analysis Set)|"Ten patients showed treatment success at week 52 with clinical global impression (CGI) evaluated as very much improved, much improved, minimally improved.~Two patients did not achieve treatment success at week 52 with CGI evaluated as missing and both were imputed as no treatment success."|52 weeks|Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.|||Participants|||Number
2620872|NCT01952015|Primary|Number of Patients With Treatment Success at Week 16 Using Non-responder Imputation (Full Analysis Set)|"Treatment success was defined as Minimally improved, Much improved or Very much improved in Clinical global impression (CGI).~Non-responder imputation assigns a value of nonresponse to missing data points, any patient who drops out is assumed to be a non-responder."|16 weeks|Full analysis set (FAS): The FAS was comprised of all patients who entered into the induction period.|||Participants|||Number
2620873|NCT01951963|Other Pre-specified|Pain Scale Rating Agreement Among Patient, Parent, and Research Staff|"FLACC scores were assessed on the patient using the FLACC scale (0-10) by the parent, treating RN/trained research assistant.~FLACC - Parents 30 Minutes Post dose~FLACC - Staff 30 Minutes Post dose~Wong-Baker Faces scale is a self-assessment of pain Scale of 1-10 pain."|Up to 3 hours post pain medication administration|Wong-Baker Faces scale is a self-assessment of pain Scale. FLACC Score (FLACC = Face, Legs, Activity, Crying and Consolability) is a behavioral observational pain rating scale that looks for specific behaviors and scores them. Both scales are scored 0-10 with 0 representing no pain. Lower scores are better outcomes.|||Scores on a scale||Standard Deviation|Mean
2620874|NCT01951963|Primary|Adverse Drug Reaction|Rate of pain medication related adverse events during their ED stay and at 24 hours post discharge from the ED. the research team will complete the Adverse Event case report form to determine any adverse events occurring during the study period. Family members will be contacted via telephone 24 hours (±8 hours) following their visit in the Emergency Department to complete the Discharge Adverse Event case report form.|3 hours post study drug administration|Rate of pain medication related adverse events during their ED stay and at 24 hours post discharge from the ED will be compared using unadjusted Fisher’s exact of a composite measure (≤ 1 events vs. > 1).|||Participants|||Count of Participants
2620875|NCT01951963|Primary|Cumulative Narcotic Consumption|All opioids administered were converted to morphine equivalents in milligrams (eq. mg) via standard equianalgesic calculations. Pre-study drug opioids information was also collected.The number of subjects who received a morphine dose after administration of the study drug, both within one hour or at all was included in the outcome measure results.|3 hours post study drug administration|The number of subjects in each group who received at least one dose of opioids post study drug.|||Participants|||Count of Participants
2620876|NCT01951950|Primary|Failure of Drug to Control Systolic Blood Pressure (SBP) < 140 mmHg||1 hour postoperatively||||participants|||Number
2620877|NCT01951820|Primary|Measurement of Pain Associated With Injection, in Millimeters, According to Visual Analog Scale|The investigation is trying to determine if the compounded topical anesthetic (Pliaglis) is more effective than the active control (benzocaine) in numbing the gums before needle penetration. The effectiveness of the topical anesthetics will be determined by the patient indicating their level of discomfort felt upon needle stick by using a Heft-Parker visual analog pain scale (scale of 0 - 170mm with 0mm equating to no pain and 170mm equating to maximum pain).|2.5 minutes||||mm||Full Range|Mean
2620878|NCT01951768|Secondary|Pathogen Eradication|Microbiological eradication of former infection|up to 38 days||||participants|||Number
2620879|NCT01951768|Secondary|Clinical Response|Clinical significant improvement is defined as significant improvement of infection but not complete cure (e.g., residual uninfected skin lesions).|up to 38 days||||participants|||Number
2620880|NCT01951768|Primary|Clinical Cure|Clinical Cure defined as the absence of any clinical, radiological or laboratory evidence of infection|Approximately day 38||||participants|||Number
2620881|NCT01951703|Primary|Subjective Overall Vision (Using CLUE )|Contact Lens User Experience Vision scores (CLUE) is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|2 weeks|Includes all subjects who completed all visits and did not have any major protocol deviation impacting the primary outcomes|||units on a scale||Standard Deviation|Mean
2620882|NCT01951703|Primary|Subjective Overall Comfort (Using CLUE )|Contact Lens User Experience Comfort scores (CLUE) is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.|2 weeks|Includes all subjects who completed all visits and did not have any major protocol deviation impacting the primary outcomes|||units on a scale||Standard Deviation|Mean
2620883|NCT01951651|Secondary|Monocyte Inflammatory Protein Nuclear Factor Kappa-B (NFkappaB) (%)|The percentage change in monocyte inflammatory proteins NFkappaB (%) from baseline.|6 months||||percentage change from baseline||Standard Error|Mean
2620884|NCT01951651|Secondary|Left Ventricular Ejection Fraction (LVEF)(%).|Left Ventricular Ejection Fraction following intervention as measured by magnetic resonance imaging in patients with type 2 diabetes.|6 months|One patient assigned to the glipizide treatment arm did not complete the Left Ventricular Ejection Fraction study (magnetic resonance imaging) following 6 months of treatment|||percent of Left ventricular function||Standard Error|Mean
2620885|NCT01951651|Primary|Hepatic Fat Content|Hepatic fat content following intervention in patients with type 2 diabetes|6 months|One patient assigned to the glipizide treatment arm did not complete the hepatic fat content study (MRS) following 6 months of treatment|||percent of hepatic fat||Standard Error|Mean
2620886|NCT01951651|Primary|Myocardial Fat Content|Myocardial fat content following intervention as measured by magnetic resonance imaging and spectroscopy (MRS) in patients with type 2 diabetes.|6 months|One patient assigned to the glipizide treatment arm did not complete the myocardial fat content study (MRS) following 6 months of treatment|||percentage of myocardium content||Standard Error|Mean
2620887|NCT01951586|Secondary|Number of Participants With Treatment-emergent Adverse Events|"An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment.~A serious adverse event is defined as an AE that meets at least 1 of the following criteria~fatal~life threatening~requires in-patient hospitalization or prolongation of existing hospitalization~results in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event Treatment-related AEs include only TEAEs for which the investigator indicated there was a reasonable possibility they may have been caused by study drug.~Fatal adverse events include only deaths reported on the Adverse Event Case Report Form."|From first dose of study drug to the end of study date; the median (min, max) duration was 10.0 (0.2, 41.4) and 9.4 (0.2, 42.9) months for Placebo and Denosumab respectively.|All randomized participants who received at least one dose of study drug (denosumab or placebo)|||participants|||Number
2620888|NCT01951586|Secondary|Serum Denosumab Trough Levels in Participants Who Received Q4W Dosing|Serum samples were analyzed for denosumab using enzyme-linked immunosorbent assay (ELISA) following a validated procedure. The lower limit of quantification for the assay was 20 ng/mL.|Prior to dosing at day 8 and weeks 4, 8, 12, 16, 20 and 24|Randomized participants who received denosumab every 4 weeks with at least one valid denosumab concentration measurement.|||ng/mL||Standard Deviation|Mean
2620889|NCT01951586|Secondary|Serum Denosumab Trough Levels in Participants Who Received Q3W Dosing|Serum samples were analyzed for denosumab using enzyme-linked immunosorbent assay (ELISA) following a validated procedure. The lower limit of quantification for the assay was 20 ng/mL.|Prior to dosing at day 8 and weeks 3, 6, 9, 12, 15, 18, 21 and 24.|Randomized participants who received denosumab every 3 weeks with at least one valid denosumab concentration measurement.|||ng/mL||Standard Deviation|Mean
2620890|NCT01951586|Secondary|Progression-free Survival (PFS)|Progression-free survival was defined as the time from randomization to the first observed disease progression per modified RECIST 1.1 criteria or death from any cause. Participants last known to be alive who did not experience disease progression were censored at their last imaging assessment date, last contact date if they were in the survival follow up phase, end of the study date, or the primary analysis cut-off date, whichever was first. If a participant underwent surgical resection while on study, the participant was censored at the last evaluable imaging assessment prior to the surgery.|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|All randomized participants|||months||95% Confidence Interval|Median
2620891|NCT01951586|Secondary|Clinical Benefit Rate|Clinical benefit rate was defined as the percentage of participants with an objective response (CR or PR) or stable disease (SD) or better for at least 16 weeks achieved over the study duration. If a participant underwent surgical resection while on study, the participant was not evaluated for response after the surgery. Participants who did not meet the criteria for clinical benefit by the analysis cutoff date were considered as non-responders.|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|Randomized participants with at least one baseline measurable lesion per modified RECIST 1.1.|||percentage of participants|||Number
2620892|NCT01951586|Secondary|Correlation of Tumor Tissue RANKL Expression With Objective Response Rate|"To assess whether the treatment effect on objective response rate (ORR) based on RECIST 1.1 was correlated with RANKL protein expression in tumor cells, RANKL expression in archival tumor samples was measured using immunohistochemistry. The intensity of stain in the cytoplasm was categorized as 0 (negative), 1+ (weak), 2+ (moderate) or 3+ (strong); All intensity is the sum of levels +1, +2 and +3. In addition, an H-score was calculated using the following formula: H-score=(percentage of cells of weak×1)+(percentage of cells of moderate×2)+(percentage of cells of strong×3). The maximum H-score was 300, corresponding to 100% of cells with strong intensity.~The correlation between RANKL expression level and ORR was evaluated within each treatment group using a logistical regression model that included RANKL expression value as an independent variable and stratified by the randomization stratification factors. The odds ratio and 95% confidence interval are reported."|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|All randomized participants with at least one baseline measurable lesion per modified RECIST 1.1 who had evaluable pre-treatment tumor RANKL expression.|||odds ratio||95% Confidence Interval|Number
2620893|NCT01951586|Secondary|Correlation of Tumor Tissue RANK Expression With Objective Response Rate|"To assess whether the treatment effect on objective response rate (ORR) based on RECIST 1.1 was correlated with RANK protein expression in tumor cells, RANK expression in archival tumor samples was measured using immunohistochemistry. The intensity of stain in the cytoplasm, membrane, and total was categorized as 0 (negative), 1+ (weak), 2+ (moderate) or 3+ (strong); All intensity is the sum of levels +1, +2 and +3. In addition, an H-score was calculated using the following formula: H-score=(percentage of cells of weak×1)+(percentage of cells of moderate×2)+(percentage of cells of strong×3). The maximum H-score was 300, corresponding to 100% of cells with strong intensity.~The correlation between RANK expression level and ORR was evaluated within each treatment group using a logistical regression model that included RANK expression value as an independent variable and stratified by the randomization stratification factors. The odds ratio and 95% confidence interval are reported."|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|All randomized participants with at least one baseline measurable lesion per modified RECIST 1.1 who had evaluable pre-treatment tumor RANK expression.|||odds ratio||95% Confidence Interval|Number
2620894|NCT01951586|Secondary|Objective Response Rate|"Objective response rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) based on modified RECIST 1.1 achieved over the study duration.~CR: Disappearance of all target and non target lesions, normalization of tumor marker levels and no new lesions.~PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, disappearance of target lesions with persistence of one or more non-target lesions and/or maintenance of tumor marker levels above normal limits and no new lesions.~Participants who underwent surgical resection while on study were not evaluated for response after the surgery. Participants who did not meet the criteria for an objective response by the analysis cutoff date were considered non-responders."|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|Randomized participants with at least one baseline measurable lesion per modified RECIST 1.1.|||percentage of participants|||Number
2620895|NCT01951586|Secondary|Correlation of Tumor Tissue RANK Ligand Expression With Overall Survival|"To assess whether the treatment effect on overall survival was correlated with RANK ligand (RANKL) protein expression in tumor cells, RANKL expression in archival tumor samples was measured using immunohistochemistry. The intensity of stain in the cytoplasm was categorized as 0 (negative), 1+ (weak), 2+ (moderate) or 3+ (strong); All intensity is the sum of levels +1, +2 and +3. In addition, an H-score was calculated using the following formula: H-score=(percentage of cells of weak×1)+(percentage of cells of moderate×2)+(percentage of cells of strong×3). The maximum H-score was 300, corresponding to 100% of cells with strong intensity.~The correlation between RANKL expression level and OS was evaluated using a Cox proportional hazard models that included RANKL expression level stratified by the randomization stratification factors in the corresponding treatment group."|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|All randomized participants who had evaluable pre-treatment tumor RANKL expression.|||hazard ratio||95% Confidence Interval|Number
2620896|NCT01951586|Secondary|Correlation of Tumor Tissue RANK Expression With Overall Survival|"To assess whether the treatment effect on overall survival was correlated with receptor activator of nuclear factor (NF)-κB (RANK) protein expression in tumor cells, RANK expression in archival tumor samples was measured using immunohistochemistry. The intensity of stain in the cytoplasm, membrane, and total was categorized as 0 (negative), 1+ (weak), 2+ (moderate) or 3+ (strong); All intensity is the sum of levels +1, +2 and +3. In addition, an H-score was calculated using the following formula: H-score=(percentage of cells of weak×1)+(percentage of cells of moderate×2)+(percentage of cells of strong×3). The maximum H-score was 300, corresponding to 100% of cells with strong intensity.~The correlation between RANK expression level and OS was evaluated using a Cox proportional hazard models that included RANK expression level stratified by the randomization stratification factors in the corresponding treatment group."|From randomization until the data cut-off date of 29 July 2016; median time on study was 9.64 months.|All randomized participants who had evaluable pre-treatment tumor RANK expression.|||hazard ratio||95% Confidence Interval|Number
2620897|NCT01951586|Primary|Overall Survival (OS)|Overall survival was calculated as the time from the date of randomization to the date of death from any cause. Participants last known to be alive were censored at the last contact date.|From randomization until the end of study; median time on study was 9.64 months.|All randomized participants|||months||95% Confidence Interval|Median
2620898|NCT01951573|Secondary|Over-refraction (OR) Monocular at Distance|OR (the amount of additional correction needed to improve VA) at distance (equivalent to 6 meters) was assessed monocularly (for each eye separately) in diopters (D). Both eyes contributed to the mean.|Dispense (Day 1), Hour 9|This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.|||Diopters|Participants|Standard Deviation|Mean
2620899|NCT01951573|Secondary|HC/HI Binocular VA at Distance|Distance VA was assessed binocularly (both eyes together) at 6 meters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.|Dispense (Day 1), Hour 9|This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.|||logMAR||Standard Deviation|Mean
2620900|NCT01951573|Primary|High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near|Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.|Dispense (Day 1), Hour 9|This analysis population includes all randomized subjects excluding those who met any of the specified deviation criteria.|||logMAR||Standard Deviation|Mean
2620901|NCT01951417|Other Pre-specified|Stinging/Burning|Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|As observed population|||participants|||Number
2620902|NCT01951417|Other Pre-specified|Dryness|Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|As observed population|||participants|||Number
2620903|NCT01951417|Other Pre-specified|Scaling|Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|As observed population|||participants|||Number
2620904|NCT01951417|Other Pre-specified|Erythema|Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|As observed population|||participants|||Number
2620905|NCT01951417|Secondary|Subject Questionnaire|Describe subject satisfaction after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.|Baseline, 2, 4, and 8 weeks|ITT population (all subjects who had at least 1 post-treatment administration evaluation)|||participants|||Number
2620906|NCT01951417|Secondary|Non-inflammatory Lesions|The change in non-inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks|Baseline, 2, 4, and 8 weeks|ITT population (all subjects who had at least 1 post-treatment administration evaluation)|||lesions||Standard Deviation|Mean
2620907|NCT01951417|Secondary|Inflammatory Lesions|The change in inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.|Baseline, 2, 4, and 8 weeks|ITT population (all subjects who had at least 1 post-treatment administration evaluation)|||lesions||Standard Deviation|Mean
2620908|NCT01951417|Primary|Total Lesion Count|The change in total lesion count after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.|Baseline, 2, 4, and 8 weeks|ITT population (all subjects who had at least 1 post-treatment administration evaluation)|||lesions||Standard Deviation|Mean
2621130|NCT01949480|Secondary|Respiratory Rate|Respiratory rate (RR) per minute after surgery.|24 hours postoperatively|There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.|||breaths per one minute||95% Confidence Interval|Mean
2620909|NCT01951391|Secondary|Relative Abundance of Staphylococcus Epidermidis of Intervention Arms|Total bacterial DNA abundance of S. epidermidis (relative to baseline) at baseline and 6 hours, before washing with any soap as measured by qPCR of 16S RNA|Baseline, 6 hours|The control soap data for all 10 subjects (5 from each treatment arm) was pooled for this analysis. The control soap subjects' forearms were were assessed at the following time points--baseline and 6 hours. The benzalkonium chloride and triclocarban forearms were assessed at the same time points.|||Percentage of Baseline||Standard Error|Mean
2620910|NCT01951391|Primary|Relative 16S Abundance - Control Soap|Total bacterial DNA abundance at baseline (relative to baseline), prior to washing with control soap (softsoap aquarium series hand soap) as measured by qPCR of 16S RNA|Baseline, 10 minutes, 6 hours, 24 hours|The control soap data for all 10 subjects (5 from each treatment arm) was pooled for this analysis. The control soap subjects' forearms were were assessed at the following time points--baseline, 10 minutes, 6 hours, and 24 hours.|||Percentage of Baseline||Inter-Quartile Range|Mean
2620911|NCT01951352|Primary|Normalized LL-37 Expression|LL-37 expression was measured using tape-stripping methods and expressed relative to baseline.|24 hours||||percentage of baseline||Standard Deviation|Mean
2620912|NCT01951352|Primary|Normalized LL-37 Expression|LL-37 expression was measured using tape-stripping methods and expressed relative to baseline.|5 minutes||||percentage of baseline||Standard Deviation|Mean
2620913|NCT01951352|Primary|Normalized LL-37 Expression|LL-37 was measured using tape-stripping methods and is expressed relative to baseline levels|4 hours||||percentage of baseline||Standard Deviation|Mean
2620914|NCT01951352|Primary|Normalized LL-37 Expression|LL-37 expression was measured using tape-stripping methods and expressed relative to baseline.|Baseline||||percentage of baseline||Standard Deviation|Mean
2620915|NCT01951339|Secondary|Change in (Non-invasively Measured) Deoxygenated Hemoglobin Concentration in the Vastus Lateralis During Exercise|Deoxygenated hemoglobin concentration will be measured using near-infrared spectroscopy during sub-maximal exercise before and after 3 months of study drug administration.|Pre-intervention (Baseline) and post-intervention (3 months)|This variable was listed as a secondary outcome of the study that was later dropped by the investigators after a careful review of the literature. We decided not to pursue this outcome because it was not scientifically useful to address the original hypothesis.||||||
2620916|NCT01951339|Secondary|Changes From Baseline in Echocardiographic Measures (Stroke Volume)|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication|Pre-intervention (Baseline) and post-intervention (3 months)||||mL/beat||Standard Deviation|Mean
2620917|NCT01951339|Primary|Changes From Baseline in 31P Measurement: pH|Potential change in muscle mitochondrial function will be assessed after three months of study medication treatment|Pre-intervention (Baseline) and post-intervention (3 months)|These data are quality control measures only.|||pH||Standard Deviation|Mean
2620918|NCT01951339|Primary|Changes From Baseline in 31P Measurement: Adenosine Diphosphate (ADP) Time Constant|Potential change in muscle mitochondrial function will be assessed after three months of study medication treatment|Pre-intervention (Baseline) and post-intervention (3 months)||||seconds||Standard Deviation|Mean
2620919|NCT01951339|Primary|Changes From Baseline in 31P Measurement: Adenosine Triphosphate (ATP) Peaks|Potential change in muscle mitochondrial function will be assessed after three months of study medication treatment|Pre-intervention (Baseline) and post-intervention (3 months)|These data are quality control measures only.|||mM||Standard Deviation|Mean
2620920|NCT01951339|Primary|Changes From Baseline in 31P Measurement: Free Pi Time Constant|Potential change in muscle mitochondrial function will be assessed after three months of study medication treatment. Data are represented as the change in Pi through the scan.|Pre-intervention (Baseline) and post-intervention (3 months)|These data are quality control measures only.|||seconds||Standard Deviation|Mean
2620921|NCT01951339|Primary|Change in Oxygen Uptake Kinetics (VO2 Kinetics)|Oxygen uptake kinetics will be tested on a stationary bike before and after 3 months of study medication. VO2 kinetics is reported as the time constant associated with the change in oxygen update from rest to steady state.|Pre-intervention (Baseline) and post-intervention (3 months)||||seconds||Standard Deviation|Mean
2620922|NCT01951339|Primary|Changes From Baseline in 31P Measurement: Phosphocreatine Time Constant|Potential change in muscle mitochondrial function will be assessed after three months of study medication treatment|Pre-intervention (Baseline) and post-intervention (3 months)||||seconds||Standard Deviation|Mean
2620923|NCT01951339|Primary|Peak Oxygen Consumption (VO2peak).|Subjects' peak oxygen consumption will be tested on a stationary bike before and after 3 months of study medication.|Pre-intervention (Baseline) and post-intervention (3 months)||||ml/min||Standard Deviation|Mean
2620924|NCT01951170|Secondary|Safety: Number of Participants With Confirmed Positive Assessment of Tocilizumab Immunogenicity|A tocilizumab antibody screen was performed at baseline and at the end of follow up (8 weeks after end of treatment at Week 32). A confirmatory anti-tocilizumab antibody test was performed on positive screen samples. A confirmed positive test indicates the presence of tocilizumab antibodies.|At baseline, Week 32 (end of follow up: 8 weeks after end of treatment)|The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||participants|||Number
2620925|NCT01951170|Secondary|Safety: Number of AEs Leading to Tocilizumab Dose Modification or Study Treatment Withdrawal||Up to Week 32 (end of follow up: 8 weeks after end of treatment)|The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||adverse events|||Number
2620926|NCT01951170|Secondary|Safety: Percentage of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to Week 32 (end of follow up: 8 weeks after end of treatment)|The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants|||Number
2624508|NCT01923480|Secondary|Plasma Concentration of Glycine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
2620927|NCT01951170|Secondary|Change From Baseline in RAMRIS Scoring of Osteitis|Osteitis (bone inflammation) was assessed by MRI at baseline and Week 24. Scans of 25 bone locations were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-3 on a 4-point scale, with 0= no osteitis, 1= 1-33% involvement of original articular bone, 2= 34-67% involvement of original articular bone and 3= 68-100% involvement of original articular bone. Total score was the sum of the 25 individual scores and ranged 0-75 with 0= no osteitis and 75= most severe osteitis. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.|||units on a scale||Standard Deviation|Mean
2620928|NCT01951170|Secondary|Change From Baseline in RAMRIS Scoring of Synovitis|Synovitis (synovial membrane inflammation) was assessed by MRI at baseline and Week 24. Scans of 8 joint locations were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-3 on a 4-point scale, with 0= no synovitis, 1= 1-33% volume enhancement, 2= 34-67% volume enhancement and 3= 68-100% volume enhancement. Total score was the sum of the 8 individual scores and ranged 0-24 with 0= no synovitis and 24= most severe synovitis. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.|||units on a scale||Standard Deviation|Mean
2620929|NCT01951170|Secondary|Change From Baseline in RAMRIS Scoring of Cartilage Loss|Cartilage loss was assessed by MRI at baseline and Week 24. Scans of 25 joints were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-4 on a 9-point scale, with 0= no cartilage loss and 4= complete cartilage loss. Total score was the sum of the 25 individual scores and ranged 0-100 with 0= no cartilage loss and 100= most severe cartilage loss. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.|||units on a scale||Standard Deviation|Mean
2620930|NCT01951170|Secondary|Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scoring of Bone Erosions|Bone erosions were assessed by magnetic resonance imaging (MRI) at baseline and Week 24. Scans of 25 bone locations were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-10 on an 11-point scale with 0= no erosion, 1= 1-10% erosion, 2= 11-20% erosion, and up to 10= 91-100% erosion. Total score was the sum of the 25 individual scores and ranged 0-250 with 0= no erosion and 250= most severe erosion. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.|||units on a scale||Standard Deviation|Mean
2620931|NCT01951170|Secondary|Change From Baseline in Swollen Joint Count (SJC)|SJC was counted based on 66 joints (SJC66) and based on 28 joints (SJC28). A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.|||swollen joints||Standard Deviation|Mean
2620932|NCT01951170|Secondary|Change From Baseline in Total Tender Joint Count (TJC)|TJC was counted based on 68 joints (TJC68) and based on 28 joints (TJC28). A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.|||tender joints||Standard Deviation|Mean
2620933|NCT01951170|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI)|The CDAI is a combined index for measuring disease activity in rheumatoid arthritis and calculated as CDAI = TJC28 + SJC28 + PGA VAS (in mm) + Physician Global Assessment of Disease Activity VAS (in mm) with a total CDAI score ranging from 0-76. Higher scores indicate greater disease activity. The SDAI scale is divided into the following categories: Clinical remission = score ≤ 2.8; Low disease activity = score > 2.8 and ≤ 10.0; Moderate disease activity = score > 10.0 and ≤ 22.0; Severe disease = score > 22.0. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.|||units on a scale||Standard Deviation|Mean
2620934|NCT01951170|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI)|The SDAI is a combined index for measuring disease activity in rheumatoid arthritis and calculated as SDAI = TJC28 + SJC28 + PGA VAS (in mm) + Physician Global Assessment of Disease Activity VAS (in mm) + C reactive protein (CRP) in milligrams/deciliter (mg/dL) with a total SDAI score ranging from 0 to 86. Higher scores indicate greater disease activity. The SDAI scale is divided into the following categories: Clinical remission = score ≤ 3.3; Low disease activity = score > 3.3 and ≤ 11.0; Moderate disease activity = score > 11.0 and ≤ 26.0; Severe disease = score > 26.0. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.|||units on a scale||Standard Deviation|Mean
2620935|NCT01951170|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)|The FACIT measurement system is a collection of health-related quality of life questionnaires targeted to the management of chronic illness and includes questions on physical well-being, social/family well-being, emotional well-being and functional well-being. The FACIT-F Scale measures an individual's level of fatigue during their usual daily activities. Total scores range from 0 to 52 with lower scores representing greater fatigue, and scores below 30 representing severe fatigue. A positive change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.|||units on a scale||Standard Deviation|Mean
2621197|NCT01948986|Primary|Change From Baseline in 24 Hour Fluid Balance|Fluid balance = fluid intake - urine output.|For 24 hours before Baseline (-48 to -24 hours) and up to 24 hours after dosing on Day 1 (Up to 24 hours)|The analysis population was defined as all treated participants who had at least one measurement for fluid balance.|||Milliliters||Standard Deviation|Mean
2620936|NCT01951170|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|HAQ-DI is the participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. A negative change from baseline indicates improvement.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.|||units on a scale||Standard Deviation|Mean
2620937|NCT01951170|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity|"The Physician Global Assessment of Disease Activity is the investigator's overall assessment of the participant's current disease activity. The disease activity is displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line is described as no disease activity (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) is described as maximum disease activity (maximum arthritis disease activity). The change in Physician Global Assessment of Disease Activity is determined as the difference in values from baseline. A negative change from baseline indicates improvement."|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.|||units on a scale||Standard Deviation|Mean
2620938|NCT01951170|Secondary|Change From Baseline in Patient's Global Assessment of Pain Using a Visual Analog Scale (PGA Pain VAS)|"The PGA pain VAS is the participant's overall assessment of pain. Pain is displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line is described as no pain and the right-hand extreme (100 mm) is described as unbearable pain. The change in PGA VAS is determined as the difference in values from baseline. A negative change from baseline indicates improvement."|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.|||units on a scale||Standard Deviation|Mean
2620939|NCT01951170|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity Visual Analog Scale (PGA VAS)|"PGA VAS is the participant's overall assessment of their current disease activity. The disease activity is displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line is described as no disease activity (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) is described as maximum disease activity (maximum arthritis disease activity). The change in PGA VAS is determined as the difference in values from baseline. A negative change from baseline indicates improvement."|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.|||units on a scale||Standard Deviation|Mean
2620940|NCT01951170|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response|EULAR response was calculated as the difference between DAS28-ESR scores at baseline and Week 24, and reported as the percentage of participants with good, moderate, or no response. Good responders = decrease from baseline >1.2 with a DAS28 score of ≤3.2; moderate responders = decrease from baseline >1.2 with a DAS28 score of >3.2, or decrease from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = decrease from baseline ≤0.6 or decrease from baseline >0.6 and ≤1.2 with a DAS28 score of >5.1.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants||95% Confidence Interval|Number
2620941|NCT01951170|Secondary|Percentage of Participants With Positive American College of Rheumatology 20/50/70 (ACR20/50/70) Responses|A positive ACR20 response requires at least 20% improvement compared to baseline in SJC (66 joints) and TJC (68 joints) as well as at least 20% improvement in 3 of the following 5 assessments: 1) PGA pain VAS, 2) PGA VAS; 3) physician's global assessment of disease activity VAS, 4) Health Assessment Questionnaire-Disability Index (HAQ-DI) with 20 questions consisting of 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do; and 5) acute phase reactant (C-reactive protein [CRP] - if not available, ESR was used). ACR50 and ACR70 responses are defined in a similar way except that they required a 50% and 70% improvement from baseline, respectively. VAS range for all assessments was 0=no disease activity to 100=maximum disease activity.|From baseline to Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants||95% Confidence Interval|Number
2620942|NCT01951170|Secondary|Percentage of Participants With Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count of 28 joints (TJC28), swollen joint count of 28 joints (SJC28), patient's global assessment of disease activity visual analog scale (PGA VAS) with 0=no disease activity to 100=maximum disease activity displayed on the 100-millimeter (mm) horizontal VAS and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to 10. Higher scores represent higher disease activity. DAS28-ESR remission is defined as a score < 2.6.|At Week 24|FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.|||percentage of participants||95% Confidence Interval|Number
2620943|NCT01951170|Primary|Change From Baseline in Genant-modified Total Sharp Score (mTSS)|The mTSS is a measure of joint damage that combines scores for bone erosion and joint-space narrowing (JNS). Erosion score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=normal to 3.5=very severe erosion. JNS score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=normal to 4.0=definite ankylosis (stiffness or fixation of a joint). mTSS scores ranged from 0 (normal) to 292 (worst possible total score). Change from baseline = mTSS score at Week 24 minus score at baseline. An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|From baseline to Week 24|Full Analysis Set (FAS) included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number analyzed represents the number of participants for whom the Week 24 X-ray was performed.|||units on a scale||Full Range|Median
2620944|NCT01951157|Secondary|Information on Quality of Life (QoL)|"The mean QoL scores self-reported by patients using the Lung Cancer Symptom Scale (LCSS) at baseline and after the start of the therapy in visits 3 or 6 (+/- 1 visit) and visit 9 for those patients in maintenance therapy.~Higher LCSS scores indicate more severe problems and the scale range is (0-100) Total score was calculated as the mean of the total scores of all nine patient ítems (Appetite, Fatigue, Cough, Dyspnea, Hemoptysis, Pain, Lung cancer symptoms, Normal activities, Global QoL)"|Baseline, Cycle 3 (~9 weeks), Cycle 6 (~18 weeks) and Cycle 9 (~27 weeks)|No patients in cycle 9 in arm A and arm C.|||units on a scale||95% Confidence Interval|Mean
2620945|NCT01951157|Secondary|Overall Survival (OS)|Overall survival (OS) will be defined as time from the date of first infusion to the date of death or last contact|From the date of first infusion to the date of death or last contact, up to 12 months after last patient inclusion|Arm B: 1 no treated, 1 no tumour assesment, 1 major protocol deviation Arm C: 2 no tumour assesment|||months||95% Confidence Interval|Median
2620946|NCT01951157|Secondary|Duration of Response|"Duration of response (DR) was defined as the time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented.~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."|The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 years|"Two patients with CR or PR to treatment as per the RECIST v.1.1 criteria were found in Arm A.~No patients with CR or PR to treatment as per the RECIST v.1.1 criteria were found in Arm B.~Four patients with CR or PR to treatment as per the RECIST v.1.1 criteria were found in Arm C."|||months||95% Confidence Interval|Median
2620947|NCT01951157|Secondary|Objective Response Per RECIST v.1.1|RECIST, Response Evaluation Criteria In Solid Tumors Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10mm Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Appearance of new lesions was considered PD Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum diameters while on study Treatment failure (TF) Symptomatic deterioration/death due to progression or treatment discontinuation due to treatment-related toxicity occurred before any appropriate tumor assessments had been performed|Time from the date of randomization until 30±7 days after the last treatment infusion, assessed up to 3 years|B- 1 no treated, 1 no tumour assesment, 1 major protocol deviation C- 2 no tumour assesment|||Participants|||Count of Participants
2620948|NCT01951157|Secondary|Overall Response Rate|"Overall response rate (ORR) was defined as the percentage of patients with a response, either CR or PR, according to RECIST v.1.1.~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."|Time from the date of randomization until 30±7 days after the last treatment infusion, assessed up to 3 years|B - 1 no treated, 1 no tumour assesment, 1 major protocol deviation C - 2 no tumour assesment|||percentage of participants||95% Confidence Interval|Number
2620949|NCT01951157|Secondary|Progression-free Survival Rate at Six Months (PFS6)|The rate estimate of the percentage of patients who are alive and progression-free at 24 weeks (~6 months) after randomization. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.|At month six after patient inclusion|B- 1 no treated, 1 no tumour assesment, 1 major protocol deviation C - 2 no tumour assesment|||percentage of participants||95% Confidence Interval|Number
2620950|NCT01951157|Secondary|Progression-free Survival|PFS, progression-free survival Progression-free survival (PFS), defined as the time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.|Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years|B- 1 no treated, 1 no tumour assesment, 1 major protocol deviation C - 2 no tumour assesment|||months||95% Confidence Interval|Median
2620951|NCT01951157|Primary|Progression-free Survival Rate at Four Months (PFS4)|The rate estimate of the percentage of patients who are alive and progression-free at 16 weeks (~4 months) after randomization. Progession disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.|At month four after patient inclusion|Arm B: 1 no treated, 1 no tumour assesment, 1 major protocol deviation Arm C: 2 no tumour assesment|||percentage of participants||95% Confidence Interval|Number
2620952|NCT01951105|Secondary|Percent of Residual Pain Stratified by Gender for Individuals Receiving Treatment|Residual pain is computed based on pain ratings from the week prior to treatment and last week of study participation (at ~6months)|6 months|This outcome is limited to arms involving medication intake, thus it only concerns to Carbidopa/Levodopa & Naproxen (males and females) and Placebo & Naproxen (males and females). It does not include the observation arm. However numbers for the observation arm are also displayed.|||% residual pain||Standard Error|Mean
2621336|NCT01947517|Secondary|Canadian Dry Eye Assessment Score|Describes the scores on a scale and range from 0-3. Higher score represents more severe dry eye. Score 0 = no dry eye symptoms, score 1 = mild dry eye symptoms, score 2 = moderate dry eye symptoms, score 3 = severe dry eye symptoms.|6 months||||scores on a scale||Standard Deviation|Mean
2620953|NCT01951105|Primary|Number of Participants With 20% Reduction in Pain on the NRS Pain Intensity Scale|Primary outcome is 20% reduction in pain intensity at p<0.1 based on pain ratings during 1 week prior to treatment and last week of study participation (at ~6months)|6 months|Note that one subject (out of 21) in the Carbidopa/Levodopa & Naproxen arm, and one subject (out of 28) in the Placebo & Naproxen arm, had missing NRS pain intensity scale ratings, hence they were excluded from primary outcome assessment.|||Participants|||Count of Participants
2620954|NCT01951092|Secondary|Efficacy|Exploratory end point of PVL <200 copies at the end of the study|6 months||||participants|||Number
2620955|NCT01951092|Primary|Number of Particpatns Who Considered the Intervention Feasible and Acceptable|A qualitative interview is completed at the end of the 6 month intervention where participants are queried on aspects of the texting intervention including: frequency of messaging, content of messaging, comfort with confidentiality with messaging, interactions between clinic staff as a result of messaging, and ideas on how to incorporate messaging clinic-wide.|6 months|All 20 participants who completed the study at 6 months participated in interviews and reported that the texting intervention was feasible and acceptable.|||participants|||Number
2620956|NCT01951066|Primary|Correlation Between Change in Level of Propermeability Factors With Change in Edema After Treatment With a Dexamethasone Implant or Anti-VEGF Agent|Changes in propermeability factor levels were correlated with changes in edema using the person correlation coefficient (this was calculated using data from all time points).|1, 2, 3, and 4 months after injection of a dexamethasone implant or anti-VEGF agent||||Pearson correlation coefficient (r)|||Number
2620957|NCT01950819|Secondary|Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death or Loss to Follow-up|Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death or loss to follow-up|Month 12 and 24|full analysis set|||Participants|||Count of Participants
2620958|NCT01950819|Secondary|Incidence of tBPAR (Excluding Grade IA Rejections) or GFR<50 mL/Min/1.73m2|Incidence of tBPAR (excluding grade IA rejections) or GFR<50 mL/min/1.73m2|Month 12 and 24|full analysis set|||Participants|||Count of Participants
2620959|NCT01950819|Secondary|Incidence of Composite of tBPAR (Treated Biopsy-proven Acute Rejection)or eGRF<50 mL/Min/1.73m2 by Subgroup|Incidence of composite of tBPAR or eGRF<50 mL/min/1.73m2 by subgroup|Month 12 and 24|full analysis set|||Participants|||Count of Participants
2620960|NCT01950819|Secondary|Incidence of tBPAR (Treated Biopsy-proven Acute Rejection) Excluding Grade IA Rejections|"Incidence of tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), excluding grade IA rejections. Grades for T-cell mediated rejection, with increasing severity:~Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IIA - Mild to moderate intimal arteritis~Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area~Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)"|Month 12 and 24|full analysis set|||Participants|||Count of Participants
2620961|NCT01950819|Secondary|Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Events)|"Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing severity:~Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IIA - Mild to moderate intimal arteritis~Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area~Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)"|Month 12 and 24|full analysis set|||events|||Number
2620962|NCT01950819|Secondary|Incidence tBPAR (Treated Biopsy-proven Acute Rejection) by Severity and Time to Event (Participants)|"Incidence tBPAR, defined as any condition where the subject received anti-rejection treatment and was histologically diagnosed as acute rejection (according to the Banff 2009 criteria), by severity (grade IA, IB, IIA, IIB, III) and time to event. Grades for T-cell mediated rejection, with increasing severity:~Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IIA - Mild to moderate intimal arteritis~Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area~Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)"|Month 12 and 24|full analysis set|||Participants|||Count of Participants
2620963|NCT01950819|Secondary|Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2 Among Compliant Subjects.|Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2 among compliant subjects.|Month 12 and 24|compliance set|||Participants|||Count of Participants
2620964|NCT01950819|Secondary|Incidence of Malignancies.|Incidence of malignancies.|Month 24|safety set|||Participants|||Count of Participants
2620965|NCT01950819|Secondary|Incidence of Major Cardiovascular Events.|Incidence of major cardiovascular events by Preferred Term|Month 24|safety set|||Participants|||Count of Participants
2620966|NCT01950819|Secondary|Urinary Protein and Albumin Excretion by Treatment Estimated by Urinary Protein/Creatinine and Urinary Albumin/Creatinine Ratios.|Mean urinary protein and albumin excretion by treatment estimated by mean urinary protein/creatinine and urinary albumin/creatinine ratios.|Baseline, Month 12 and 24|safety set with measure|||mg/g||Standard Deviation|Mean
2621337|NCT01947517|Primary|Length of Retention||6 months||||months||Standard Deviation|Mean
2620967|NCT01950819|Secondary|Incidence of Cytomegalovirus and BK Virus, New Onset Diabetes Mellitus, Chronic Kidney Disease With Associated Proteinuria and Calcineurin Inhibitor Associated Adverse Events.|Incidence of cytomegalovirus and BK virus, new onset diabetes mellitus, chronic kidney disease with associated proteinuria and calcineurin inhibitor associated adverse events.|Month 24|safety set|||Participants|||Count of Participants
2620968|NCT01950819|Secondary|Incidence of Adverse Events, Serious Adverse Events and Adverse Events Leading to Study Regimen Discontinuation.|Incidence of adverse events, serious adverse events and adverse events leading to study regimen discontinuation.|Month 24|safety set 24 months analysis|||Participants|||Count of Participants
2620969|NCT01950819|Secondary|Renal Function by Alternative Formulae (e.g. CKD-EPI). eGFR Values Reported|Mean Renal function as used in clinical practice, using different formula for calculation of renal function than MDRD4 (our primary efficacy parameter), and other alternate formulae (e.g. CKD-EPI). Analysis is done without considering missing values for analysis.|Month 12 and 24|full analysis set with measure|||mL/min/1.73m2||Standard Deviation|Mean
2620970|NCT01950819|Secondary|Renal Function Assessed by Creatinine Lab Values|Mean Renal function as assessed in clinical practice, by ceatinine values. Analysis is done without considering missing values for analysis.|Month 12 and 24|full analysis set with measure|||micromol/L||Standard Deviation|Mean
2620971|NCT01950819|Secondary|Evolution of Renal Function, as eGFR, Over Time by Slope Analysis.|Rate of change of renal function, as eGFR, calculated using MDRD4 formula (Coresh, 2003) and adjusted by covariates.|Month 12 and 24|full analysis set|||mL / min / 1.73m2 / day||Standard Error|Mean
2620972|NCT01950819|Secondary|Renal Allograft Function : Mean Estimated Glomerular Filtration Rate, eGFR|Renal allograft function : mean estimated glomerular filtration rate, eGFR|Baseline (week 4), Month 12 and 24|full analysis set|||mL/min/1.73m2||Standard Error|Mean
2620973|NCT01950819|Secondary|Incidence of eGFR < 50 mL/Min/1.73m2|Incidence of eGFR < 50 mL/min/1.73m2|Month 12 and 24|full analysis set|||Participants|||Count of Participants
2620974|NCT01950819|Secondary|Incidence of Death, Graft Loss, tBPAR, BPAR, tAR, AR and Humoral Rejection|Incidence of death, graft loss, tBPAR (treated biopsy proven acute rejection), BPAR (biopsy proven acute rejection), tAR (treated acute rejection), AR (acute rejection) and humoral rejection (aAMR : active antibody mediated rejection and cAMR: chronic antibody mediated rejection)|Month 12 and 24|full analysis set|||Participants|||Count of Participants
2620975|NCT01950819|Secondary|Incidence of Failure on the Composite Endpoint of Graft Loss or Death.|Incidence of failure on the composite endpoint of graft loss or death.|Month 12 and 24|full analysis set|||Participants|||Count of Participants
2620976|NCT01950819|Secondary|Incidence of Failure on the Composite Endpoint of tBPAR, Graft Loss, Death or eGFR < 50 mL/Min/1.73m2|Incidence of failure on the composite endpoint of tBPAR, graft loss, death or eGFR < 50 mL/min/1.73m2|Month 12 and 24|full analysis set|||Participants|||Count of Participants
2620977|NCT01950819|Secondary|Incidence of Failure on the Composite of (Treated Biopsy Proven Acute Rejection (tBPAR), Graft Loss or Death|Incidence of failure on the composite of (treated biopsy proven acute rejection (tBPAR), graft loss or death|Month 12 and 24|full analysis set|||Participants|||Count of Participants
2620978|NCT01950819|Primary|Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2.|Incidence of failure on the composite of treated biopsy-proven acute rejection (tBPAR) or estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2.|Month 12 is Primary, Month 24 secondary|full analysis set|||Participants|||Count of Participants
2620979|NCT01950780|Secondary|Percentage of Regrowth|Mean percentage of regrowth was calculated at the end of treatment for all subjects.|Up to 6 months||||percentage of regrowth||Standard Deviation|Mean
2620980|NCT01950780|Primary|Change in SALT Score|Severity of Alopecia Tool Score (SALT) calculation is based on a scoring system. The scalp is divided into the following 4 areas: 1) Vertex: 40% (0.4) of scalp surface area, 2) Right profile of scalp: 18% (0.18) of scalp surface area, 3) Left profile of scalp: 18% (0.18) of scalp surface area, and 4) Posterior aspect of scalp: 24% (0.24) of scalp surface area. The percentage of hair loss in any of these areas is the percentage hair loss multiplied by percent surface area of the scalp in that area. The SALT score is the sum of percentage of hair loss in all the above-mentioned areas, so a lower number indicates a better outcome. The reported SALT score range is from a minimum of 0 (no hair loss) to a maximum of 100 (100% hair loss).|Baseline, 3 months and 6 months||||score on a scale||Standard Deviation|Mean
2620981|NCT01950741|Secondary|VFQ (Visual Function Questionaire)-25 Score|Quality of life was assessed using VFQ -25 score . The VFQ-25 includes 25 questions, and the total score ranges from 0 to 100. Higher scores represents better functioning.|12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.|||scores on a scale||Inter-Quartile Range|Mean
2620982|NCT01950741|Secondary|Percentage of Patients Having Complete Resulution of Polypoidal Lesion in ICG Angiography|ICG angiography was assessed at 12 months. when no polypoidal lesion was detected, it was defined as complete resolution.|12 months|Among 45 patients who completed the study, data of 6 were inadequate for the analysis. 39 patients were included in the analysis.|||percentage of patients|||Number
2620983|NCT01950741|Secondary|Percentage of Patients With Visual Acuity >=20/40|Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients with visual acuity 70 ETDRS letters (equivalent to 20/40) or better was calculated.|12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.|||percentage of patients|||Number
2620984|NCT01950741|Secondary|Percentage of Patients With Visual Acuity >=20/200|Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. Percentage of patients with visual acuity 35 ETDRS letters (equivalent to 20/200) or better was calculated.|12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.|||percentage of patients|||Number
2624509|NCT01923480|Secondary|Plasma Concentration of Glutamine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
2620985|NCT01950741|Secondary|Change in Visual Acuity From Baseline to 12 Months|Mean changes of visual acuity in ETDRS letters. Visual acuity was assessed using ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning. A change of 5 letters is equivalent to a 1-line change.|Baseline and 12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.|||letters||Full Range|Mean
2620986|NCT01950741|Primary|Percentage of Patients Lose Visual Acuity Less Than 15 Letters|Visual acuity was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Visual acuity of 85 letters is equivalent to 20/20. Higher scores represents better functioning.|12 months|Among 45 patients who completed the study, data of 5 were inadequate for the analysis. Forty patients were included in the analysis as per protocol set.|||percentage of patients|||Number
2620987|NCT01950663|Primary|Per Patient Referral Accuracy|Accuracy will be reported as count of participants with referral status correctly identified, sensitivity, and specificity, with ETDRS photography and reading as the gold standard.|During a single visit, implicit time, measured by the RETeval device, and ETDRS photography, will be performed to support the analysis of the accuracy of the RETeval device.|Participants with gradeable fundus photos and RETeval measurements|||Participants|||Count of Participants
2620988|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 480-504 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2620989|NCT01950364|Secondary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, body weight, blood pressure and heart rate.|Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2620990|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 336-360 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2620991|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 144-168 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2620992|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 120-144 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2620993|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 96-120 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2620994|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 72-96 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2620995|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 48-72 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2620996|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 24-48 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2620997|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: 0-24 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2620998|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 3: Predose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2620999|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 480-504 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2621000|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 336-360 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2621001|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 144-168 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2621002|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 120-144 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2621003|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 96-120 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2621004|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 72-96 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2621005|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 48-72 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2621006|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 24-48 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2621007|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: 0-24 hours postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2621008|NCT01950364|Primary|Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.|Cycle 1: Predose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng||Standard Deviation|Geometric Mean
2621009|NCT01950364|Secondary|Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.|Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2621010|NCT01950364|Secondary|Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin|Participants with positive ATA at both Cycle 1 and 3, negative ATA at both Cycle 1 and 3, and transient positive (positive at one time point, but negative at the other) ATA for brentuximab vedotin were reported.|Day 1 of Cycle 1 and 3|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2621011|NCT01950364|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. AEs included both SAE and non-SAE.|Baseline up to 30 days after last dose of study drug (30 days after Cycle 16)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2621012|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 480 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621013|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 336 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621014|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 336 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621015|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 144 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621016|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 144 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621017|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 96 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621018|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 96 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621019|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 72 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621020|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 72 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621338|NCT01947491|Primary|Percentage of Participants With Success According to the Investigator Global Assessment (IGA)|IGA of clear or almost clear|Day 15|Efficacy was only done on DFD01 Spray and Vehicle Spray. Protocol specifically noted no efficacy would be done on comparator or its vehicle.|||percentage of patients||95% Confidence Interval|Number
2621021|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 48 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621022|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 48 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621023|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 24 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621024|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 24 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621025|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 4 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621026|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 4 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621027|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: 0.5 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621028|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 2: 0.5 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621029|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 1: 0.5 hour postdose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621030|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 3: Predose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621031|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.|Cycle 2: Predose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621032|NCT01950364|Secondary|Serum Concentration of Total Antibody (TAb)|The LLQ for all the observations was 12.5 ng/mL.|Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621033|NCT01950364|Secondary|Serum Concentrations of Antibody-drug Conjugate (ADC)|The LLQ for all the observations was 12.5 ng/mL.|Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dose|PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621034|NCT01950364|Primary|Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose|Metabolites of MMAE includes C4, C5, C7, C8 and C13. The lower limit of Quantification (LLQ) for all the observations was 0.01 nanogram/milliliter (ng/mL).|Cycle 1: Predose|Pharmacokinetic (PK) analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.|||ng/mL||Standard Deviation|Geometric Mean
2621035|NCT01950299|Secondary|Heart Failure|New onset of heart failure symptoms (NYHA II-IV)|12 months||||Participants|||Count of Participants
2621036|NCT01950299|Secondary|Left Ventricular Ejection Fraction|Placebo-corrected interval changes in left ventricular ejection fraction over 12 months|12 months||||% (Left ventricular ejection fraction)||Inter-Quartile Range|Median
2621037|NCT01950299|Secondary|Left Ventricular End-systolic Volume|Placebo corrected interval change in left ventricular end-systolic volume over 12 months|12 months||||mL (milliliters)||Inter-Quartile Range|Median
2621039|NCT01950273|Secondary|Percentage of Patients With Treatment Emergent Adverse Events (TEAEs) Selected for Comparability Assessment of BI 695500 and Rituximab (MabThera®)|This outcome measure presents percentage of patients with Treatment Emergent Adverse Events (TEAEs) selected for comparability assessment of BI 695500 and Rituximab (MabThera®).|Adverse Events (AEs) that started or worsened on or after the first dose of study medication and prior to the last date of study medication + 4 months (120 days) inclusive.|Safety Analysis Set (SAS): The patients who received at least one dose of trial medication and classified as per treatment received.|||Percentage of patients|||Number
2621040|NCT01950273|Secondary|Overall Response Rate (ORR) (Complete Response (CR) Plus Partial Response (PR)) Evaluated Approximately One Month After Last Dose of BI 695500 or Rituximab (MabThera®)|Overall Response Rate (ORR) comprised Complete Response (CR) plus Partial Response (PR) evaluated approximately one month after last dose of BI 695500 or Rituximab [MabThera®]. Overall Response as defined by the revised International Working Group (IWG) Criteria 2007, using the Investigator's assessment.|at Day 50.|Safety Analysis Set (SAS): The patients who received at least one dose of trial medication and classified as per treatment received.|||Percentage of subjects|||Number
2621041|NCT01950273|Secondary|Change From Baseline (%) of CD19+ B-cells in Peripheral Blood Measured After Seven Days on Day 8 (Day 8 Pre-infusion Time Point)|This outcome measure presents percent change from baseline of CD19+ B-cells in peripheral blood, measured after 7 days (i.e., Day 8 pre-infusion time point) (PCFBpre,2 CD19+).|Blood sampling was done at 168 hours from start of infusion.|The PK analysis Set Descriptive (PKSD) consisted of all randomized subjects who received at least one dose of trial medication BI 695500 or Rituximab [MabThera®], had at least one post-treatment PK concentration value and were without important protocol deviations that would significantly affect the PK of BI 695500 or Rituximab (MabThera®).|||Percentage (%) CFB of CD19+ B-cells||Standard Deviation|Mean
2621042|NCT01950273|Secondary|Area Under the Depletion-time Curve of the Cluster of Differentiation (CD)19+ B-cell Count (% Change From Baseline (CFB)) in Peripheral Blood From Pre-infusion on Day 1 Until Last Measurement on Day 8 (Pre-infusion)|This outcome measure presents area under the depletion-time curve of the CD19+ B-cell count (% change from baseline) in peripheral blood from pre-infusion on Day 1 until last measurement on Day 8 (pre-infusion) (AUC Day 1-Day 8, CD19+).|Blood samplings were done at pre-infusion and at end of infusion at 1, 2, and 4 hours from end of infusion, and at 24, 48, 72, 96 and 168 hours from start of infusion.|The PK analysis Set Descriptive (PKSD) consisted of all randomized subjects who received at least one dose of trial medication BI 695500 or Rituximab [MabThera®], had at least one post-treatment PK concentration value and were without important protocol deviations that would significantly affect the PK of BI 695500 or Rituximab (MabThera®).|||Percentage CFB of CD19+ B-cells*hour||Standard Deviation|Mean
2621043|NCT01950273|Secondary|Maximum Measured Concentration of Rituximab (MabThera®) and BI 695500 in Plasma (Cmax) Following Dose 4|This outcome measure presents maximum measured concentration of Rituximab (MabThera®) and BI 695500 in plasma (Cmax) following Dose 4.|Blood samplings were done at pre-infusion and at end of infusion at 1, 2, and 4 hours from end of infusion 4, and at 24, 48, 72, 96, 168, 336, 672, 1344, 2016 and 2880 hours from start of infusion 4.|The PK analysis Set Inferential (PKSI) used for inferential analysis of PK parameters, consisted of all randomized subjects who received at least one dose of trial medication and had estimable primary PK parameter value and were without important protocol deviations that would significantly affect the PK of BI 695500 or Rituximab (MabThera®).|||microgram/millilitre (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2621044|NCT01950273|Secondary|Maximum Measured Concentration of BI 695500 and Rituximab (MabThera®) in Plasma (Cmax) Following Dose 1|This outcome measure presents maximum measured concentration of BI 695500 and Rituximab (MabThera®) in plasma (Cmax) following Dose 1|Blood samplings were done at pre-infusion and at end of infusion at 1, 2, and 4 hours from end of infusion 1, and at 24, 48, 72, 96 and 168 hours from start of infusion 1.|The PK analysis Set Inferential (PKSI) used for inferential analysis of PK parameters, consisted of all randomized subjects who received at least one dose of trial medication and had estimable primary PK parameter value and were without important protocol deviations that would significantly affect the PK of BI 695500 or Rituximab (MabThera®).|||microgram/millilitre (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2621045|NCT01950273|Secondary|AUC of BI 695500 and Rituximab (MabThera®) Over the Fourth Dosing Interval (Pre-infusion on Day 22 to Day 29) (AUC Day 22-Day 29)|This outcome measure presents area under the concentration of BI 695500 and Rituximab (MabThera®) over the fourth dosing interval (pre-infusion on Day 22 to Day 29).|Blood samplings were done at pre-infusion and at end of infusion at 1, 2, and 4 hours from end of infusion 4, and at 24, 48, 72, 96 and 168 hours from start of infusion 4.|The PK analysis Set Inferential (PKSI) used for inferential analysis of PK parameters, consisted of all randomized subjects who received at least one dose of trial medication and had estimable primary PK parameter value and were without important protocol deviations that would significantly affect the PK of BI 695500 or Rituximab (MabThera®).|||microgram*hour/millilitre (µg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2621046|NCT01950273|Primary|Area Under the Concentration (AUC) Time Curve of BI 695500 and Rituximab (MabThera®) Over the First Dosing Interval (Pre-infusion on Day 1 to Pre-infusion on Day 8)|This outcome measure presents area under the concentration time curve of BI 695500 and Rituximab (MabThera®) over the first dosing interval (pre-infusion on Day 1 to pre-infusion on Day 8) (AUCDay 1-Day 8) for assessment of PK (Pharmacokinetics) similarity.|Blood samplings were done at pre-infusion and at end of infusion at 1, 2, and 4 hours from end of infusion 1, and at 24, 48, 72, 96 and 168 hours from start of infusion 1.|The PK analysis Set Inferential (PKSI) used for inferential analysis of PK parameters, consisted of all randomized subjects who received at least one dose of trial medication and had an estimable primary PK parameter value and were without important protocol deviations that would significantly affect the PK of BI 695500 or Rituximab (MabThera®).|||microgram*hour/millilitre (µg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2621060|NCT01949545|Secondary|Mean Residence Time (MRT) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
2621339|NCT01947335|Secondary|Incidence of Contrast-induced Nephropathy|Increase >= 0.5 mg/dl in basal serum creatinine|7 days||||percentage of participants|||Number
2621047|NCT01950260|Secondary|Change in Thyroid Specific Quality of Life|The mean change in quality of life scores was measured by the Thyroid Specific Questionnaire (TSQ). This questionnaire consists of 12 questions ranked on a four-point scale for each question where 0 is 'better than usual' and 3 is 'much less than usual'. A higher score indicates higher levels of dissatisfaction and a lower quality of life. The change between weeks 4 and 8 were assessed using a hierarchical linear model. The primary parameter of interest from the model was the treatment by time interaction term. Time was a collection of indicator values representing each assessment point.|4 weeks, 8 weeks||||units on a scale||Standard Deviation|Mean
2621048|NCT01950260|Secondary|Change in Hypothyroid-Health Related Quality of Life|"The mean change in Quality of life scores was measured by the Hypothyroid-Health Related Quality of Life (HRQL) questionnaire. This questionnaire consists of 27 questions specifying the severity of the discomfort or symptoms of hypothyroidism using a 5 point scale for each question with not at all=1 to all the time=5. Higher scores are associated with a lower quality of life. The change between weeks 4 and 8 were assessed using a hierarchical linear model. The primary parameter of interest from the model was the treatment by time interaction term. Time was a collection of indicator values representing each assessment point."|4 weeks, 8 weeks||||units on a scale||Standard Deviation|Mean
2621049|NCT01950260|Primary|Number of Participants With Overt Hypothyroidism|Incidence of overt hypothyroidism at 8 weeks post radioactive iodine treatment (RAI). Overt hypothyroidism was defined as thyroid stimulating hormone (TSH) test result > 3.0 milliunits per liter (mIU/L) or thyroid hormone free T4 (fT4) < 0.8 nanograms per deciliter (ng/dL). Free T4 is the portion of total T4 thyroid hormone that is available to your tissues in your bloodstream.|8 weeks||||Participants|||Count of Participants
2621050|NCT01950078|Secondary|Preoperative Pressure Pain Tolerance (PTO)|"The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say ok when they started to feel the pain became intolerable during the stimulation. The value from the LCD was recorded as the pressure pain tolerance."|30 minutes before the operation||||kg/cm2||Standard Deviation|Mean
2621051|NCT01950078|Primary|Preoperative Pressure Pain Threshold (PPT)|"The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say pain when they started to feel pain during the stimulation. The value from the LCD was recorded as the pressure pain threshold."|30 minutes before the operation||||kg/cm2||Standard Deviation|Mean
2621052|NCT01950013|Secondary|Change in Aided Profile of Hearing Aid Performance (PHAP) Score|Change in aided performance on the Profile of Hearing Aid Performance (PHAP), a self-report measure of the frequency of listening difficulties experienced by the individual. The aided PHAP scores are proportions of time difficulties encountered in various listening situations while wearing hearing aids. Low PHAP scores indicate less frequent difficulties and reflect better aided performance. The range of possible PHAP scores are 0.0 to 1.0.There are seven subscales of the PHAP and the scores reported are based on the arithmetic means of the five subscales that deal with speech communication, PHAP global. These include the following subscale scores: EC (Ease of Communication), FT (Familiar Talkers), BN (Background Noise), Reverberation (RV) and Reduced Cues (RC). Scores reported below are the CHANGE in aided PHAP global scores, baseline minus post-training.|Baseline (pre-training) and 6 weeks later (post training)||||proportion of time had difficulties||Standard Deviation|Mean
2621053|NCT01950013|Primary|Change in Connected Speech Test (CST) Score|"The CST is an objective measure of speech-understanding in noise that will be obtained when the patient's are wearing their hearing aids. The patient hears standardized recordings of the speech in noise and then reports the sentences that were heard. These are scored as percent correct. Baseline AIDED CST score was obtained prior to the intervention period and immediately following 6-week intervention. The results reflect the CHANGE in CST from pre- to post-intervention with positive numbers indicating improved speech understanding in noise following training."|Baseline (prior to training) and 6-weeks later (after training)||||percent-correct words||Standard Deviation|Mean
2621054|NCT01949870|Primary|The Number of Dose-limiting Toxicities|The number of dose-limiting toxicities in selumetinib in combination with cisplatin and gemcitabine|The first cycle with selumetinib until Day 1 of Cycle 2 of combination dosing|Evaluable = completed at least 75% of planned daily doses of selumetinib at least 50% of planned dose of cisplatin/gemcitabine planned on Cycle 1 Day 8 (therefore, in total with Cycle 1 Day 1, at least 75 % of planned dose is given in Cycle 1) and has enough information to be assessed for the combination regimen dose escalation.|||Participants|||Number
2621055|NCT01949844|Primary|Diagnostic Performance (Specificity and Sensitivity) for Detection of Myocardial Perfusion Deficits on Magnetic Resonance (MR) Images|In this study, the approach is to use nuclear myocardial perfusion (prior PET/SPECT scans for the enrolled patients) as the comparative standard for detection of myocardial ischemia (presence of perfusion deficits). Using this approach, the acquired MR images will be analyzed to determine the diagnostic performance (specificity and sensitivity) of the improved MRI technique for detection of myocardial perfusion deficits.|Baseline only|Patients who did not have diagnostically interpretable MRI data were not analyzed.|||percentage of true cases|||Number
2621056|NCT01949779|Secondary|Procedural Technical Success|Ability of TransForm™ OBC to Perform as Intended|post-procedure||||Catheters|||Number
2621057|NCT01949779|Secondary|Angiographic Assessment on Catheter|Visibility of TransForm™ OBC on angiography|intra-procedure||||Catheters|Catheters|Standard Deviation|Mean
2621058|NCT01949779|Primary|Catheters Visualized That Reached Intended Target|The number of TransForm™ OBC catheters that reached the intended target location confirmed by angiography visualization.|intra-procedure|The number of catheters exceeds the number of participants enrolled, as more than one catheter may have been used for each participant.|||Catheters|Catheters|Standard Deviation|Mean
2621059|NCT01949545|Secondary|Number of Participants With Adverse Events (AEs)|"Treatment-related adverse events (TRAEs) are adverse events considered related to carfilzomib by the investigator, including those with unknown relationship.~Adverse events were graded using National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, on a scale from 1 (mild) to 5 (death)."|From the first dose of carfilzomib until 30 days after last dose; the overall median duration of treatment was 4.2 weeks||||participants|||Number
2621061|NCT01949545|Secondary|Terminal Half-life for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
2621062|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||hours||Full Range|Median
2621063|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2621064|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2621065|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-519/M16||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2621066|NCT01949545|Secondary|Mean Residence Time (MRT) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
2621067|NCT01949545|Secondary|Terminal Half-life for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
2621068|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||hours||Full Range|Median
2621069|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2621070|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2621071|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-413/M15||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2621072|NCT01949545|Secondary|Mean Residence Time (MRT) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
2621073|NCT01949545|Secondary|Terminal Half-life for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
2621074|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||hours||Full Range|Median
2621075|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2621076|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2621340|NCT01947335|Secondary|Major Adverse Cardiac Events|Composite of death, myocardial infarction or repeat revascularization|30 days and 6 months||||participants|||Number
2621077|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) for Metabolite PR-389/M14||Cycle 1 day 16 and cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population, defined as all participants who had adequate carfilzomib exposure and plasma concentration versus time data for the estimation of PK parameters by a non-compartmental analysis at each time point.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2621078|NCT01949545|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||liters||Geometric Coefficient of Variation|Geometric Mean
2621079|NCT01949545|Secondary|Mean Residence Time (MRT) of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
2621080|NCT01949545|Secondary|Clearance of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||L/hour||Geometric Coefficient of Variation|Geometric Mean
2621081|NCT01949545|Secondary|Terminal Half-life of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
2621082|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||hours||Full Range|Median
2621083|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) of Carfilzomib 56 mg/m²||Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2621084|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Carfilzomib 56 mg/m²|The area under the curve from time zero extrapolated to infinity (AUC0-inf) following intravenous administration of carfilzomib 56 mg/m² on day 1 of cycle 2 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.|Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2621085|NCT01949545|Secondary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) of Carfilzomib 56 mg/m²|The area under the curve from time zero to the last concentration measured (AUC0-last) following intravenous administration of carfilzomib 56 mg/m² on day 1 of cycle 2 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.|Cycle 2 day 1 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2621086|NCT01949545|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib 27 mg/m²||Cycle 1 day 16 pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||liters||Geometric Coefficient of Variation|Geometric Mean
2621087|NCT01949545|Secondary|Mean Residence Time (MRT) of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
2621088|NCT01949545|Secondary|Terminal Half-life of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||hours||Geometric Coefficient of Variation|Geometric Mean
2621089|NCT01949545|Secondary|Clearance of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||L/hour||Geometric Coefficient of Variation|Geometric Mean
2621090|NCT01949545|Secondary|Time to Maximum Plasma Concentration (Tmax) of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||hours||Full Range|Median
2621091|NCT01949545|Secondary|Maximum Plasma Concentration (Cmax) of Carfilzomib 27 mg/m²||Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2621341|NCT01947335|Primary|Total Volume of Iodine Contrast Used During Procedure|Total volume of iodine contrast administered during the index procedure.|Day 1||||ml||Inter-Quartile Range|Median
2621092|NCT01949545|Primary|Area Under the Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Carfilzomib 27 mg/m²|The area under the curve from time zero extrapolated to infinity (AUC0-inf) following intravenous administration of carfilzomib 27 mg/m² on day 16 of cycle 1 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.|Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population with data to allow terminal phase characterization|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2621093|NCT01949545|Primary|Area Under the Concentration Time Curve From Time Zero to Last Concentration Measured (AUC0-last) of Carfilzomib 27 mg/m²|The area under the curve from time zero (defined as the start of carfilzomib infusion) to the last concentration measured (AUC0-last) following intravenous administration of carfilzomib 27 mg/m² on day 16 of cycle 1 was calculated using a non-compartmental approach, from the individual plasma concentration profiles of carfilzomib.|Cycle 1 day 16, pre-dose, 15 minutes after the start of infusion, immediately (within 2 minutes) before the end of infusion, and at 5, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.|Pharmacokinetic-evaluable population, defined as participants who received the intended carfilzomib dose (27 or 56 mg/m²) and who had plasma concentration versus time data for the estimation of each pharmacokinetic (PK) parameter by a non-compartmental analysis.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2621094|NCT01949532|Secondary|Number of Participants With Adverse Events (AEs)|"Determination of the severity of all adverse events was assessed following the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Fatal.~A Serious AE is an AE that meets one or more of the following criteria:~Death,~Life-threatening experience;~Requires in-patient hospitalization or prolongation of an existing hospitalization,~Results in persistent or significant disability/incapacity,~Is a congenital anomaly/birth defect,~Important medical events that may not result in death, be life-threatening, or require hospitalization.~Treatment-related adverse events (TRAEs) are adverse events considered related to carfilzomib by the investigator, including those with unknown relationship."|From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 12 October 2015; median duration of treatment was 14 weeks in the normal renal function group and 12 weeks in the ESRD group.|All treated participants|||participants|||Number
2621095|NCT01949532|Secondary|Terminal Half-life (T½) of Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||hours||Full Range|Median
2621096|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) for Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||hours||Full Range|Median
2621097|NCT01949532|Secondary|Maximum Observed Plasma Concentration (Cmax) for Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2621098|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) for Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2621099|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) for Metabolite PR-519/M16||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2621100|NCT01949532|Secondary|Terminal Half-life (T½) of Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants for whom the extrapolated portion of AUC0-∞ was > 20% were excluded.|||hours||Full Range|Median
2621101|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) for Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||hours||Full Range|Median
2621102|NCT01949532|Secondary|Maximum Observed Plasma Concentration (Cmax) for Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2621103|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) for Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants for whom the extrapolated portion of AUC0-∞ was > 20% were excluded.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2621104|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) for Metabolite PR-413/M15||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2621105|NCT01949532|Secondary|Terminal Half-life (T½) of Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population. Participants for whom the extrapolated portion of AUC0-∞ was > 20% were excluded. T½ could not be calculated for the ESRD group as the extrapolated portion (AUCextr) was greater than 20% in all participants.|||hours||Full Range|Median
2621106|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) for Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||hours||Full Range|Median
2621107|NCT01949532|Secondary|Maximum Observed Plasma Concentration for Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2621108|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) for Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population. Participants for whom the extrapolated portion of AUC0-∞ was > 20% were excluded. AUC0-∞ could not be calculated for the ESRD group as the extrapolated portion (AUCextr) was greater than 20% in all participants.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2621109|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) for Metabolite PR-389/M14||Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|"PK evaluable population; One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. n indicates the number of participants included in the analyses at each time point."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2621110|NCT01949532|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||liters||Geometric Coefficient of Variation|Geometric Mean
2621111|NCT01949532|Secondary|Mean Residence Time (MRT) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants with a coefficient of correlation (R²) < 0.8 were excluded.|||hours||Geometric Coefficient of Variation|Geometric Mean
2621112|NCT01949532|Secondary|Clearance (CL) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||liters/hour||Geometric Coefficient of Variation|Geometric Mean
2621113|NCT01949532|Secondary|Terminal Half-life (T½) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants with a coefficient of correlation (R²) < 0.8 were excluded.|||hours||Full Range|Median
2621114|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||hours||Full Range|Median
2621115|NCT01949532|Secondary|Maximum Observed Plasma Concentration (Cmax) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2621116|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site. Participants for whom the coefficient of correlation (R²) was < 0.8 were excluded.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2621514|NCT01945294|Secondary|Percentage of Participants With Anemia|The percentage of participants with anemia (hemoglobin [Hgb] <10 g/dL) was determined in each arm.|Up to 60 weeks|The All Participants as Treated (APaT) includes all participants who received ≥1 dose of study drug.|||Percentage of Participants|||Number
2621117|NCT01949532|Secondary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) of Carfilzomib Following 27 mg/m² Carfilzomib on Day 16 of Cycle 1||Cycle 1, day 16 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 1, day 16. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2621118|NCT01949532|Secondary|Volume of Distribution at Steady State (Vss) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||liters||Geometric Coefficient of Variation|Geometric Mean
2621119|NCT01949532|Secondary|Mean Residence Time (MRT) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||hours||Geometric Coefficient of Variation|Geometric Mean
2621120|NCT01949532|Secondary|Clearance (CL) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||liters/hour||Geometric Coefficient of Variation|Geometric Mean
2621121|NCT01949532|Secondary|Terminal Half-life (T½) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||hours||Full Range|Median
2621122|NCT01949532|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||hours||Full Range|Median
2621123|NCT01949532|Secondary|Maximum Observed Plasma Concentration (Cmax) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2621124|NCT01949532|Primary|Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2||Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm, distal to the infusion site.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2621125|NCT01949532|Primary|Area Under the Concentration Time Curve From Time 0 to Last Concentration (AUC0-last) of Carfilzomib Following 56 mg/m² Carfilzomib on Day 1 of Cycle 2|Carfilzomib plasma concentrations for pharmacokinetic (PK) analyses were measured by liquid chromatography with tandem mass spectrometry. The lower limit of quantitation (LLOQ) for the assay was 0.3 ng/mL.|Cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.|PK evaluable population for cycle 2, day 1. The PK evaluable population is defined as participants with sufficient carfilzomib plasma concentration versus time data for the estimation of PK parameters by non-compartmental analysis on cycle 1, day 16 and/or cycle 2, day 1. One participant was excluded due to samples taken from the infusion arm.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2621126|NCT01949480|Secondary|Total Number of Local Anesthetic Boluses in 24 Hours|Total Number of Local Anesthetic bolus doses given within the 24-hours post-operatively.|postoperatively, up to 24 hours|There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.|||number of boluses||95% Confidence Interval|Mean
2621127|NCT01949480|Secondary|Peak Expiratory Flow Rate(PEF)|Peak expiratory flow rate preoperatively (PEF) and at 24 - hour interval. Then values were analyzed as percentage in change from per-surgery measurement (post-surgery/pre-surgery).|Preoperatively and postoperatively|There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.|||percentage in change from per-surgery||95% Confidence Interval|Mean
2621128|NCT01949480|Secondary|Forced Expiratory Volume in 1 Sec (FEV1)|Forced expiratory volume in 1 sec (FEV1) preoperatively and at 24 - hour interval. Then the values were analyzed as percentage in change from per-surgery measurement (post-surgery/pre-surgery).|Preoperatively and postoperatively|There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.|||percentage in change from per-surgery||95% Confidence Interval|Mean
2621129|NCT01949480|Secondary|Forced Vital Capacity (FVC)|Forced vital capacity (FVC) measured preoperatively and at 24 - hour interval. Then values were analyzed as percentage in change from per-surgery measurement (post-surgery/pre-surgery).|Preoperatively and postoperatively|There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.|||percentage in change from per-surgery||95% Confidence Interval|Mean
2621131|NCT01949480|Secondary|Incentive Spirometry|Inspiratory Volume as measured by incentive spirometer preoperatively and at 24 hours post PCA initiation. The data is reported as a percentage in change from per-surgery measurements (post-surgery/pre-surgery).|Preoperatively and Postoperatively|There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.|||percentage in change from per-surgery||95% Confidence Interval|Mean
2621132|NCT01949480|Secondary|Inspired Oxygen Concentration and Blood Oxygen Saturation (SpO2)|Inspired oxygen concentration and SpO2 preoperatively and at 24 - hour interval. Value reported is an average of the preoperative and the 24-hour postoperative SpO2 measurements.|Pre-operatively and at 24 hour post-operative|There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.|||Percentage of SpO2||95% Confidence Interval|Mean
2621133|NCT01949480|Secondary|Total Local Anesthetic Infusions Over 24- Hour Period|The total local anesthetic infusions over 24- hour period.|24 hours postoperatively|There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.|||mL||95% Confidence Interval|Mean
2621134|NCT01949480|Secondary|Number of Local Anesthetic Boluses Requested by PCA|The number of local anesthetic boluses over 24- hour period post PCA initiation will also be recorded.|24 hours postoperatively|There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.|||Number of boluses requested||95% Confidence Interval|Mean
2621135|NCT01949480|Secondary|Pain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing|The pain level assessed using an 11-point numerical rating scale (NRS) with 0 indicating no pain and 10 indicating the worst pain possible with deep breathing and rest at 24 hours post PCA initiation.|24 hours post PCA initiation|There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.|||units on a scale||95% Confidence Interval|Mean
2621136|NCT01949480|Secondary|Sensory Level|Sensory level as assessed by temperature and pin prick test assessed every 5 min for 30 min after nerve block as defined as the patient returning to their bed. Data below are in number of patients who didn't have any change during the ice and pin prik test.|6 assessments starting 5 minutes after nerve block and ending 30 minutes after nerve block.|There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.|||Participants|||Count of Participants
2621137|NCT01949480|Primary|Opioid Consumption at 24 Hours Postoperatively|Hydromorphone (Dilaudid) consumption or opiate equivalent at 24-hour interval post PCA initiation at the post-anesthesia care unit (PACU).|24 hours after patient-controlled analgesia (PCA) was initiated|There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.|||mg||95% Confidence Interval|Mean
2621138|NCT01949389|Primary|Completion of All 7 Modules of the Intervention|"Participants will be followed for the duration of the intervention (7 individual modules, completed weekly, for an expected average of 7 weeks). Outcome measure will be characterized as the number completing all 7 modules of the program (dichotomous variable).~The intervention is a 7-week, self-administered course accessed via the Internet that includes instruction on psycho-education, stimulus control, relaxation training, sleep restriction, medication tapering, cognitive distortions, and mindfulness integrated into each module. Homework is assigned after each module. Participants are instructed to complete the sleep diary included in the program daily while participating in the program."|on average 7 weeks||||participants|||Number
2621139|NCT01949389|Primary|Insomnia Severity Index (Total), Change From Baseline to Follow-up|"Insomnia Severity Index (Total) following completion of the intervention (expected average of 7 weeks)~The Insomnia Severity Index is a self-report seven-item measure that targets the subjective symptoms and functional consequences of insomnia as well as the degree of concerns or distress caused by those difficulties, and corresponds to the diagnostic criteria of insomnia. Scores range from 0-28, higher scores indicate more severe insomnia, and scores ≥15 suggest moderate to severe insomnia."|pre-intervention, intervention completion (expected average of 7 weeks)|The number of individuals provided access to the program and reporting baseline and follow-up data|||units on a scale||Standard Deviation|Mean
2621140|NCT01949155|Secondary|Microbiological Response|Subjects whose samples tested positive for bacteria in either or both ears at baseline with documented eradication or presumed eradication post-baseline.|Day 15 - 2 weeks after dosing|Microbiologically Evaluable Set|||percentage of Microbiological response|||Number
2621141|NCT01949155|Secondary|Evaluation of Adverse Events, Otoscopic Exams, Audiometry and Tympanometry|Safety variables included the frequency of adverse events (AEs) and results from otoscopic examinations, tympanometry, audiometry measurements.|Up to one month|Safety Analysis Set (number of ears is equivalent to number of participants)|||percentage of ears|||Number
2621142|NCT01949155|Primary|Percentage of Participants Who Were Treatment Failures.|"Cumulative proportion of treatment failures:~The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up."|Day 15 - 2 weeks after dosing|Full Analysis Set|||percentage of treatment failures|||Number
2621143|NCT01949142|Secondary|Microbiological Response|Subjects whose samples tested positive for bacteria in either or both ears.|Day 15 - 2 weeks after dosing|Microbiologically Evaluable Set|||percentage of Microbiological response|||Number
2621144|NCT01949142|Secondary|Evaluation of Adverse Events, Otoscopic Exams, Audiometry, and Tympanometry|Safety variables included the frequency of adverse events (AEs) and results from otoscopic examinations, tympanometry, audiometry, vital sign measurements, and physical examinations.|Up to one month|Safety Analysis Set (number of ears is equivalent to number of participants)|||percentage of ears|||Number
2621145|NCT01949142|Primary|Percentage of Participants Who Were Treatment Failures|"Cumulative proportion of treatment failures:~The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up."|Day 15 - 2 weeks after dosing|Full Analysis Set|||percentage of treatment failures|||Number
2621146|NCT01949116|Secondary|Absolute Change From Baseline to Week 24 in Homing Molecule (CX3CR1+) Expression|CX3CR1+ is a cellular marker of immune activation. The outcome measured is the percentages of CX3CR1+ expressions in both parent CD4+ and CD8+ T cells. Absolute change from baseline (Week 24 - baseline) was analyzed on the measured scale, which is the percent of parent cells (either CD4+ or CD8+) that express CX3CR1+ cells.|From Baseline to Week 24|Adequately-dosed (AD) population included 129 participants who initiated study treatment with 24-week continuous dosing to at least 8 or more 15 mg doses of LDMTX/Placebo (59 in LDMTX, 70 in Placebo). 3 of these participants were not identified at the time of the specimen request for biomarker testing, other missing data are due to missed visits.|||Percent of Expression in Parent Cell||95% Confidence Interval|Mean
2621147|NCT01949116|Secondary|Absolute Change From Baseline to Week 24 in Adhesion and Activation Indices|The adhesion and activation indices of interest are the percentages of CD38+HLADR+ expressions in both parent CD4+ and CD8+ T cells. Absolute change from baseline (Week 24 - baseline) was analyzed on the measured scale, which is the percent of parent cells (either CD4+ or CD8+) that express CD38+HLADR+ cells.|From Baseline to Week 24|Adequately-dosed (AD) population included 129 participants who initiated study treatment with 24-week continuous dosing to at least 8 or more 15 mg doses of LDMTX/Placebo (59 in LDMTX, 70 in Placebo). 3 of these participants were not identified at the time of the specimen request for biomarker testing, other missing data are due to missed visits.|||Percent of Expression in Parent Cell||95% Confidence Interval|Mean
2621148|NCT01949116|Secondary|Absolute Change From Baseline to Week 24 in Monocyte Levels|Three categories of monocyte levels are presented: classical (CD14+CD16-), intermediate (CD14+CD16+), and non-classical (CD14dimCD16+). Absolute change from baseline (Week 24 - baseline) was analyzed on the measured scale, which is the percent of parent cells that express the subset of interest.|From Baseline to Week 24|Adequately-dosed (AD) population included 129 participants who initiated study treatment with 24-week continuous dosing to at least 8 or more 15 mg doses of LDMTX/Placebo (59 in LDMTX, 70 in Placebo). 3 of these participants were not identified at the time of the specimen request for biomarker testing, other missing data are due to missed visits.|||Percent of Expression in Parent Cell||95% Confidence Interval|Mean
2621149|NCT01949116|Secondary|Percentage Change From Baseline to Week 24 in D-Dimer|D-dimer (or D dimer) is a marker of coagulation activation. Change from baseline (Week 24 - baseline) was performed on the log10 scale and is thus presented as percentage change, i.e. (10^[fold-change] - 1) x 100%.|From Baseline to Week 24|Adequately-dosed (AD) population included 129 participants who initiated study treatment with 24-week continuous dosing to at least 8 or more 15 mg doses of LDMTX/Placebo (59 in LDMTX, 70 in Placebo). 3 of these participants were not identified at the time of the specimen request for biomarker testing, other missing data are due to missed visits.|||Percentage Change||95% Confidence Interval|Mean
2621150|NCT01949116|Secondary|Percentage Change From Baseline to Week 24 in Soluble CD 163 (sCD163)|sCD163 is a marker of Macrophage activation. Change from baseline (Week 24 - baseline) was performed on the log10 scale and is thus presented as percentage change, i.e. (10^[fold-change] - 1) x 100%.|From Baseline to Week 24|Adequately-dosed (AD) population included 129 participants who initiated study treatment with 24-week continuous dosing to at least 8 or more 15 mg doses of LDMTX/Placebo (59 in LDMTX, 70 in Placebo). 3 of these participants were not identified at the time of the specimen request for biomarker testing, other missing data are due to missed visits.|||Percentage Change||95% Confidence Interval|Mean
2621151|NCT01949116|Secondary|Percentage Change From Baseline to Week 24 in Interleukin-6 (IL-6)|IL-6 is a marker of systemic inflammation. Change from baseline (Week 24 - baseline) was performed on the log10 scale and is thus presented as percentage change, i.e. (10^[fold-change] - 1) x 100%.|From Baseline to Week 24|Adequately-dosed (AD) population included 129 participants who initiated study treatment with 24-week continuous dosing to at least 8 or more 15 mg doses of LDMTX/Placebo (59 in LDMTX, 70 in Placebo). 3 of these participants were not identified at the time of the specimen request for biomarker testing, other missing data are due to missed visits.|||Percentage Change||95% Confidence Interval|Mean
2621152|NCT01949116|Secondary|Percentage Change From Baseline to Week 24 in High-sensitivity C-reactive Protein (hsCRP)|hsCRP is a marker of inflammation. Change from baseline (Week 24 - baseline) was performed on the log10 scale and is thus presented as percentage change, i.e. (10^[fold-change] - 1) x 100%. One single hsCRP result at week 24 was above the limit of quantification, therefore excluded from analysis.|From Baseline to week 24|Adequately-dosed (AD) population included 129 participants who initiated study treatment with 24-week continuous dosing to at least 8 or more 15 mg doses of LDMTX/Placebo (59 in LDMTX, 70 in Placebo). 3 of these participants were not identified at the time of the specimen request for biomarker testing, other missing data are due to missed visits.|||Percentage Change||95% Confidence Interval|Mean
2621153|NCT01949116|Secondary|Change From Baseline to Week 24 in Peak Reactive Hyperemic (RH) Flow Velocity|The absolute change in peak RH flow velocity in cm/s of the brachial artery at week 24 from baseline.|From Baseline to Week 24|Intent-to-treat (ITT) population consists of all eligible participants who were randomized for the study.|||cm/s||Inter-Quartile Range|Median
2621154|NCT01949116|Secondary|Change From Baseline to Week 24 in Reactive Hyperemic (RH) Flow Rate|The absolute change in RH flow rate in cc/min of the brachial artery at week 24 from baseline.|From Baseline to Week 24|Intent-to-treat (ITT) population consists of all eligible participants who were randomized for the study.|||cc/min||Inter-Quartile Range|Median
2621155|NCT01949116|Secondary|Change From Baseline to Week 24 in Brachial Artery Resting Average Diameter|The absolute change in resting average diameter in millimeters of the brachial artery at week 24 from baseline.|From Baseline to Week 24|Intent-to-treat (ITT) population consists of all eligible participants who were randomized for the study.|||mm||Inter-Quartile Range|Median
2621156|NCT01949116|Secondary|Change From Baseline to Week 12 in Brachial Artery Resting Average Diameter|The change in resting average diameter in millimeters of the brachial artery at week 12 from baseline.|From Baseline to Week 12|Intent-to-treat (ITT) population consists of all eligible participants who were randomized for the study.|||mm||Inter-Quartile Range|Median
2621157|NCT01949116|Secondary|Change From Baseline to Week 12 in Brachial Artery FMD|The absolute change from baseline to week 24 FMD (%), defined as the maximum FMD calculated from reactive hyperemia (RH) 60 and RH 90 relative to resting artery diameter.|From Baseline to Week 12|Intent-to-treat (ITT) population consists of all eligible participants who were randomized for the study.|||Percent Dilation||Inter-Quartile Range|Median
2621158|NCT01949116|Primary|Primary Efficacy Endpoint of Change From Baseline to Week 24 in Brachial Artery Flow-mediated Vasodilation (FMD)|Flow-mediated vasodilation is defined as the maximum FMD (%) calculated from reactive hyperemia (RH) 60 and RH 90 relative to resting artery diameter. Absolute change of FMD at week 24 is calculated from baseline FMD.|From Baseline to Week 24|Intent-to-treat (ITT) population consists of all eligible participants who were randomized for the study.|||Percent Dilation||95% Confidence Interval|Mean
2621159|NCT01949116|Primary|Number of Participants Who Reached at Least One Safety Milestone Over the Duration of Study Follow-up (36 Weeks)|"Number of participants who experienced any one of the following safety milestones:~Entry CD4+ T-cell count less than 700 cells/mm^3, confirmed CD4+ decline greater than 33% of baseline AND to less than 350 cells/mm^3~Entry CD4+ T-cell count greater than or equal to 700 cells/mm^3, a confirmed CD4+ decline greater than 50% of baseline~Confirmed HIV-1 RNA Level Greater Than 200 Copies/mL in the Absence of an Interruption in ART~New or recurrent CDC category C AIDS-indicator condition~Evidence of HIV-associated infection including CMV end-organ disease, varicella zoster, EBV related clinical disease~Requirement for LDMTX discontinuation for confirmed Grade 3 or higher toxicity~Lymphoproliferative malignancies~Pulmonary toxicity which is defined as Grade 3 or 4 dyspnea, cough, shortness of breath which in the opinion of the local investigator is related to the study drug but not related to other clinical causes such as asthma, influenza, etc."|From study entry to week 36|Intent-to-treat (ITT) population consists of all eligible participants who were randomized for the study.|||Participants|||Count of Participants
2621160|NCT01949090|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (From Day 0 up to Month 12)|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2621161|NCT01949090|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 21-day (From Day 0 to Day 20) post-vaccination period after each dose|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2621162|NCT01949090|Secondary|Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)|An pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 42 up to Month 12|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2621163|NCT01949090|Secondary|Number of Subjects With Any Medically-attended Adverse Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.|From Day 42 up to Month 12|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2621164|NCT01949090|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Anhui/1/2013 (H7N9) Virus Strain|Vaccine response was defined as: For initially seronegative subjects antibody titer ≥ 1:56 at post-vaccination]; For initially seropositive subjects antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/Anhui/1/2013 (H7N9).|At Days 21 and 42 and at Month 6|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 21 and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6.|||Participants|||Count of Participants
2621165|NCT01949090|Secondary|Titers for Antibodies Against Flu A/Anhui/1/2013 Strain of Influenza Disease Vaccine-homologous (H7N9)|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/Anhui/1/2013. The reference seropositivity cut-off value was ≥ 1:28.|At Days 0, 21 and 42 and at Month 6|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6.|||Titers||95% Confidence Interval|Geometric Mean
2621166|NCT01949090|Secondary|Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9)|Seropositivity cut-off values assessed were equal to or above (≥) 1:28 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Anhui/1/2013 (H7N9).|At Days 0, 21 and 42 and at Month 6|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21 and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6.|||Participants|||Count of Participants
2621187|NCT01949090|Primary|Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values|Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].|At Day 7|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 7.|||Participants|||Count of Participants
2621167|NCT01949090|Secondary|Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain|Vaccine response was defined as: For initially seronegative subjects antibody titer ≥ 1:56 at post-vaccination]; For initially seropositive subjects antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).|At Days 21 and 42 and at Month 6|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 21 and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6.|||Participants|||Count of Participants
2621168|NCT01949090|Secondary|Titers for Serum Neutralizing Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1)|Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/mallard/NL/12/2000. The reference seropositivity cut-off value was ≥ 1:28.|At Days 0, 21 and 42 and at Month 6|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6.|||Titers||95% Confidence Interval|Geometric Mean
2621169|NCT01949090|Secondary|Number of Subjects With HI Neutralizing Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1)|Seropositivity cut-off values assessed were equal to or above (≥) 1:28 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).|At Days 0, 21 and 42 and Month 6|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Month 6 data was obtained from the ATP cohort for immunogenicity at Month 6.|||Participants|||Count of Participants
2621170|NCT01949090|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9)|GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9).|At Days 21 and 42 and at Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Fold increase||95% Confidence Interval|Geometric Mean
2621171|NCT01949090|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-heterologous (H7N9)|SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9).|At Days 21 and 42 and at Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Participants|||Count of Participants
2621172|NCT01949090|Secondary|Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-heterologous (H7N9)|Seroprotection (SPR) was defined as the proportion of subjects with H7N9 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9).|At Days 0, 21 and 42 and at Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Participants|||Count of Participants
2621173|NCT01949090|Secondary|Titers for Antibodies Against Flu A/Shanghai/2/2013 Strain of Influenza Disease Vaccine-heterologous (H7N9)|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9).|At Days 0, 21 and 42 and at Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Titers||95% Confidence Interval|Geometric Mean
2621174|NCT01949090|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-heterologous (H7N9)|Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/Shanghai/2/2013 (H7N9).|At Days 0, 21 and 42 and at Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Participants|||Count of Participants
2621175|NCT01949090|Secondary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1)|GMFR, also known as seroconversion factor (SCF), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).|At Days 21 and 42 and at Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Fold increase||95% Confidence Interval|Geometric Mean
2621196|NCT01948986|Secondary|Urinary Glucose Excretion Over 24 Hours (UGE0-24hr) for Ertugliflozin|Participants were asked to void at the end of each prescribed interval with forced voids prior to start and at the end of each interval.|0-4, 4-8, 8-12, 12-24 hours after dosing on Day 1|The analysis population was defined as all treated participants who had at least one concentration measurement for UGE0-24hr.|||Grams||Geometric Coefficient of Variation|Geometric Mean
2621176|NCT01949090|Secondary|Number of Seroconverted (SCR) Subjects for HI Antibodies for Vaccine-homologous (H7N1)|SCR was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer < 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post-vaccination reciprocal titer against the vaccine virus. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).|At Days 21 and 42 and at Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Participants|||Count of Participants
2621177|NCT01949090|Secondary|Number of Seroprotected (SPR) Subjects Against HI Antibodies for Vaccine-homologous (H7N1)|Seroprotection (SPR) was defined as the proportion of subjects with H7N1 reciprocal HI titers equal to or above (≥) 1:40 against the tested vaccine virus. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).|At Days 0, 21 and 42 and at Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Participants|||Count of Participants
2621178|NCT01949090|Secondary|Titers for Antibodies Against Flu A/Mallard/NL/12/2000 Strain of Influenza Disease Vaccine-homologous (H7N1)|Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).|At Days 0, 21, 42 and Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Titers||95% Confidence Interval|Geometric Mean
2621179|NCT01949090|Secondary|Number of Subjects With HI Antibody Concentrations Above the Cut-off Value for Vaccine-homologous (H7N1)|Seropositivity cut-off values assessed were equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was Flu A/mallard/NL/12/2000 (H7N1).|At Days 0, 21, 42 and Months 6 and 12|The analysis was performed on the adapted According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for which Days 0, 21, and 42 data were obtained from the ATP cohort for immunogenicity at Day 42; Months 6 and 12 data were obtained from the ATP cohorts for immunogenicity at Months 6 and 12 respectively.|||Participants|||Count of Participants
2621180|NCT01949090|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 up to Day 42|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2621181|NCT01949090|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|From Day 0 up to Day 42|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2621182|NCT01949090|Primary|Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)|Any pIMD was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.|From Day 0 up to Day 42|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2621183|NCT01949090|Primary|Number of Subjects With Any Medically-attended Adverse Events (MAEs)|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|From Day 0 up to Day 42|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2621184|NCT01949090|Primary|Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values|Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].|At Day 42|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 42.|||Participants|||Count of Participants
2621185|NCT01949090|Primary|Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values|Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].|At Day 28|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 28.|||Participants|||Count of Participants
2621186|NCT01949090|Primary|Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values|Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].|At Day 21|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available at Day 21.|||Participants|||Count of Participants
2624510|NCT01923480|Secondary|Plasma Concentration of Glutamic Acid||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
2621188|NCT01949090|Primary|Number of Subjects With Abnormal Haematological and Biochemical Laboratory Values|Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST], basophils [BAS], creatinine [CRE], eosinophils [EOS], hematocrit [HEM], hemoglobin [HgB], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].|At Day 0|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2621189|NCT01949090|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = general symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2621190|NCT01949090|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort (TVc), which included all vaccinated subjects for whom safety data were available.|||Participants|||Count of Participants
2621191|NCT01949090|Primary|Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain|GMFR, also known as seroconversion factor (SCR) or mean geometric increase (MGI), was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available. This primary outcome was centered on the groups that received GSK2789869A vaccine.|||Fold increase||95% Confidence Interval|Geometric Mean
2621192|NCT01949090|Primary|Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.|At Day 42|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available. This primary outcome measure was centered on the groups that received GSK2789869A vaccine.|||Participants|||Count of Participants
2621193|NCT01949090|Primary|Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/Mallard/NL/12/2000 (H7N1) Virus Strain|Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 10 post-vaccination], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/mallard/Netherlands/12/2000 NIBRG-63 (H7N1) (Flu A/mallard/NL/12/2000 H7N1).|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom data concerning immunogenicity outcome measure were available. This primary outcome measure was centered on the groups that received GSK2789869A vaccine.|||Participants|||Count of Participants
2621194|NCT01949051|Secondary|Weighted Mean of the Symptom Scores for the Four Individual Components of the Total Nasal Symptom Score (TNSS) (Nasal Congestion, Rhinorrhea, Nasal Itching and Sneezing) (0-4) Hours Post Start of the Allergen Chamber Challenge on Day 8|TNSS contains symtom scores for the four individual components (nasal congestion [NACG], rhinorrhea [RHSCR], nasal itching [NAITS] and sneezing [SNZS]), each scored on a 0 - 3 scale [0=none, 1=mild, 2=moderate, 3=severe]). TNSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen is administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. The participants recorded their symptom scores on an e-diary. The mean score for each participant was calculated using the available diary data from the assessment periods, taking the average of non-missing data during the period. Weighted mean of the individual symptoms of theTNSS were calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each treatment period (up to 13 Weeks)|ITT Population. Only those participants contributing data at the indicated time points were analyzed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2621195|NCT01949051|Primary|Weighted Mean of the Total Nasal Symptom Score (TNSS) (0-4) Hours (h) Post Start of Allergen Chamber Challenge on Day 8|The TNSS (score of 0-12) is defined as the sum of the symptom scores for the four individual components (nasal congestion, rhinorrhea, nasal itch, and sneezing, each scored on 0-3 scale [0=none, 1=mild, 2=moderate, 3=severe]). TNSS was measured at the pre-allergen chamber challenge, and then every 15 minutes from 0 to 4 hours post start of the allergen chamber challenge. In the Environmental Exposure Chamber (EEC), aerosolized allergen was administered in a sealed chamber to evaluate the efficacy of antihistamines/other treatments. Weighted mean TNSS was calculated by dividing the value of the area under the response time curve over the 0-4 hours (calculated by trapezoidal rule) by the time interval of available data.|Day 8 of each treatment period (up to 13 Weeks)|Per Protocol Population: all participants in the Intent-to-Treat Population (defined as all participants who were randomized and received >= 1 dose of study medication) and not identified as full protocol deviators with respect to criteria that were considered to impact the primary efficacy analysis. Only those participants contributing data at the|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2621198|NCT01948986|Primary|Change From Baseline in 24 Hour Inhibition of Glucose Reabsorption|Inhibition of Glucose Reabsorption = 100 * urinary glucose excretion / (eGFR(ML/MIN) * Weighted Mean Plasma Glucose * 0.0144). 0.0144 is a unit conversion factor used to make the ratio unitless. Geometric Coefficient of Variation was reported as a percent.|Baseline and 24 Hours|The analysis population was defined as all treated participants who had at least one concentration measurement for plasma glucose concentration.|||Percentage||Geometric Coefficient of Variation|Geometric Mean
2621199|NCT01948986|Primary|Renal Clearance (CLr) for Urinary Glucuronide Metabolite PF-06685948|"Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined.~CLr is Renal Clearance (Ae96 / AUC96), where Ae96 is the cumulative amount of drug recovered unchanged in urine to 96 hours post dose and AUC96 was the area under the concentration-time profile form time 0 to 96 hours. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined. Geometric Coefficient of Variation was reported as a percent."|0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1|The analysis population was defined as all treated participants who had at least one concentration measurement for CLr.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2621200|NCT01948986|Primary|Cumulative Amount of Drug Recovered Unchanged in Urine to 96 Hours Post Dose (Ae96) for Glucuronide Metabolite PF-06685948|"Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined.~Ae96 = Sum of [urine concentration × sample volume] for each collection interval from 0 to 96 hours post dose. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined. Geometric Coefficient of Variation was reported as a percent."|0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1|The analysis population was defined as all treated participants who had at least one concentration measurement for Ae96.|||Milligrams||Geometric Coefficient of Variation|Geometric Mean
2621201|NCT01948986|Primary|Terminal Half-life (t1/2) for Plasma Glucuronide Metabolite PF-06685948|T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. T1/2 = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined.|Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose|The analysis population was defined as all treated participants who had at least one concentration measurement for t1/2.|||Hours||Standard Deviation|Mean
2621202|NCT01948986|Primary|Time for Cmax (Tmax) for Plasma Glucuronide Metabolite PF-06685948|Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose and is observed directly from data as time of first occurrence. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined.|Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose|The analysis population was defined as all treated participants who had at least one concentration measurement for Tmax.|||Hours||Full Range|Median
2621203|NCT01948986|Primary|Maximum Observed Plasma Concentration (Cmax) for Glucuronide Metabolite PF-06685948|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined. Geometric Coefficient of Variation was reported as a percent.|Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose|The analysis population was defined as all treated participants who had at least one concentration measurement for Cmax.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2621204|NCT01948986|Primary|Area Under the Plasma Concentration-Time Profile for Glucuronide Metabolite PF-06685948 From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time profile from Time 0 to the time of the last quantifiable concentration (Clast). Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined. Geometric Coefficient of Variation was reported as a percent.|Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose|The analysis population was defined as all treated participants who had at least one concentration measurement for AUClast.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2621205|NCT01948986|Primary|Area Under the Plasma Concentration-Time Profile for Glucuronide Metabolite PF-06685948 From Time 0 Extrapolated to Infinite Time (AUCinf)|Area under the plasma concentration-time profile from Time 0 extrapolated to infinite time. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF-06685948 was determined. Geometric Coefficient of Variation was reported as a percent.|Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose|The analysis population was defined as all treated participants who had at least one concentration measurement for AUCinf.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2621206|NCT01948986|Primary|CLr for Urinary Glucuronide Metabolite PF-06481944|"Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined.~CLr is Renal Clearance (Ae96 / AUC96), where Ae96 is the cumulative amount of drug recovered unchanged in urine to 96 hours post dose and AUC96 was the area under the concentration-time profile form time 0 to 96 hours. Geometric Coefficient of Variation was reported as a percent."|0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1|The analysis population was defined as all treated participants who had at least one concentration measurement for CLr.|||mL/min.||Geometric Coefficient of Variation|Geometric Mean
2621207|NCT01948986|Primary|Cumulative Amount of Drug Recovered Unchanged in Urine to 96 Hours Post Dose (Ae96) for Glucuronide Metabolite PF-06481944|"Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined.~Ae96 = Sum of [urine concentration × sample volume] for each collection interval from 0 to 96 hours post dose. Geometric Coefficient of Variation was reported as a percent."|0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1|The analysis population was defined as all treated participants who had at least one concentration measurement for Ae96.|||Milligrams||Geometric Coefficient of Variation|Geometric Mean
2621515|NCT01945294|Secondary|Percentage of Participants With Neutropenia|The percentage of participants with neutropenia (neutrophil count <0.75 x10^9/L) is summarized for each arm.|Up to 60 weeks|The All Participants as Treated (APaT) includes all participants who received ≥1 dose of study drug.|||Percentage of Participants|||Number
2621208|NCT01948986|Primary|Terminal Half-life (t1/2) for Plasma Glucuronide Metabolite PF-06481944|T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. T1/2 = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF 06481944 was determined.|Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose|The analysis population was defined as all treated participants who had at least one concentration measurement for t1/2.|||Hours||Standard Deviation|Mean
2621209|NCT01948986|Primary|Time for Cmax (Tmax) for Plasma Glucuronide Metabolite PF-06481944|Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose and is observed directly from data as time of first occurrence. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF 06481944 was determined.|Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose|The analysis population was defined as all treated participants who had at least one concentration measurement for Tmax.|||Hours||Full Range|Median
2621210|NCT01948986|Primary|Maximum Observed Plasma Concentration (Cmax) for Glucuronide Metabolite PF-06481944|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF 06481944 was determined. Geometric Coefficient of Variation was reported as a percent.|Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose|The analysis population was defined as all treated participants who had at least one concentration measurement for Cmax.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2621211|NCT01948986|Primary|Area Under the Plasma Concentration-Time Profile for Glucuronide Metabolite PF-06481944 From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time profile from Time 0 to the time of the last quantifiable concentration (Clast). Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF 06481944 was determined. Geometric Coefficient of Variation was reported as a percent.|Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose|The analysis population was defined as all treated participants who had at least one concentration measurement for AUClast.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2621212|NCT01948986|Primary|Area Under the Plasma Concentration-Time Profile for Glucuronide Metabolite PF-06481944 From Time 0 Extrapolated to Infinite Time (AUCinf)|Area under the plasma concentration-time profile from Time 0 extrapolated to infinite time. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of glucuronide metabolite PF 06481944 was determined. Geometric Coefficient of Variation was reported as a percent.|Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose|The analysis population was defined as all treated participants who had at least one concentration measurement for AUCinf.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2621213|NCT01948986|Primary|Number of Participants Who Discontinued Study Due to an AE|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 5 days|The analysis population was defined as all treated participants.|||Participants|||Number
2621214|NCT01948986|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 19 days|The analysis population was defined as all treated participants.|||Participants|||Number
2621215|NCT01948986|Primary|Renal Clearance (CLr) for Urinary Ertugliflozin|"Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined.~CLr is Renal Clearance (Ae96 / AUC96), where Ae96 is the cumulative amount of drug recovered unchanged in urine to 96 hours post dose and AUC96 was the area under the concentration-time profile form time 0 to 96 hours. Geometric Coefficient of Variation was reported as a percent."|0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1|The analysis population was defined as all treated participants who had at least one concentration measurement for CLr.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2621216|NCT01948986|Primary|Percent of Dose Recovered Unchanged in Urine From 0 to 96 Hours Postdose (for Ertugliflozin Only) (Ae96%)|"Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined.~Ae96% = Ae96 / Dose × 100 Ae96 = Sum of [urine concentration × sample volume] for each collection interval from 0 to 96 hours post dose. Geometric Coefficient of Variation was reported as a percent."|0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1|The analysis population was defined as all treated participants who had at least one concentration measurement for Ae96.|||Percent||Geometric Coefficient of Variation|Geometric Mean
2621217|NCT01948986|Primary|Cumulative Amount of Drug Recovered Unchanged in Urine to 96 Hours Post Dose (Ae96)|"Urine samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined.~Ae96 = Sum of [urine concentration × sample volume] for each collection interval from 0 to 96 hours post dose. Geometric Coefficient of Variation was reported as a percent."|0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours after dosing on Day 1|The analysis population was defined as all treated participants who had at least one concentration measurement for Ae96.|||Milligrams||Geometric Coefficient of Variation|Geometric Mean
2621218|NCT01948986|Primary|Unbound Fraction (Fu) for Plasma Ertugliflozin|Fraction of unbound (not protein-bound) drug in plasma. Fu is determined using in vitro equilibrium dialysis method: concentration in buffer at equilibrium/concentration in plasma at equilibrium. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined.|Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose|The analysis population was defined as all treated participants who had at least one concentration measurement for Fu.|||Percent of Unbound Drug||Standard Deviation|Mean
2622230|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6)||Visit 7 (Month 6)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||participants|||Number
2621219|NCT01948986|Primary|Apparent Volume of Distribution Following Oral Administration (Vz/F) for Plasma Ertugliflozin|VzF is the apparent volume of distribution during terminal phase after oral / extravascular administration. VzF = Dose/(AUCinf × kel) where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Geometric Coefficient of Variation was reported as a percent.|Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose|The analysis population was defined as all treated participants who had at least one concentration measurement for Vz/F.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2621220|NCT01948986|Primary|Terminal Half-Life (t1/2) for Plasma Ertugliflozin|T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. T1/2 = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined.|Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose|The analysis population was defined as all treated participants who had at least one concentration measurement for t1/2.|||Hours||Standard Deviation|Mean
2621221|NCT01948986|Primary|Time for Cmax (Tmax) for Plasma Ertugliflozin|Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose and is observed directly from data as time of first occurrence. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined.|Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose|The analysis population was defined as all treated participants who had at least one concentration measurement for Tmax.|||Hours||Full Range|Median
2621222|NCT01948986|Primary|Maximum Observed Plasma Concentration (Cmax) for Ertugliflozin|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Geometric Coefficient of Variation was reported as a percent.|Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose|The analysis population was defined as all treated participants who had at least one concentration measurement for Cmax.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2621223|NCT01948986|Primary|Apparent Clearance (CL/F) for Plasma Ertugliflozin|CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes). Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Geometric Coefficient of Variation was reported as a percent.|Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose|The analysis population was defined as all treated participants who had at least one concentration measurement for CL/F.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2621224|NCT01948986|Primary|Area Under the Plasma Concentration-Time Profile for Ertugliflozin From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time profile from Time 0 to the time of the last quantifiable concentration (Clast). Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Geometric Coefficient of Variation was reported as a percent.|Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose|The analysis population was defined as all treated participants who had at least one concentration measurement for AUClast.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2621225|NCT01948986|Primary|Area Under the Plasma Concentration-Time Profile for Ertugliflozin From Time 0 Extrapolated to Infinite Time (AUCinf)|Area under the plasma concentration-time profile from Time 0 extrapolated to infinite time. Blood samples were taken at pre-dose up to 96 hours post-dose, from which the concentration of ertugliflozin was determined. Geometric Coefficient of Variation was reported as a percent.|Time 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours post-dose|The analysis population was defined as all treated participants who had at least one concentration measurement for AUCinf.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2621226|NCT01948947|Secondary|Percent Change in Depression Score From Baseline to 1-Week Post-treatment|Subjects assessed how their headaches interfered with their mood through the Hamilton Rating Scale for Depression assessment at baseline, 1-week follow-up and 1-month follow-up. The outcome was measured by adding the score of each question on the assessment and then comparing the averaged scores at the different time points. The larger the depression score, the more severe the depression. A larger percent change in depression score indicates a change in the severity of the depression.|Subjects will have a total of 9 visits over the span of 3 months and 3 of those visits will qualify as a time point at which outcome is measured.||||percent change in score from baseline||Standard Deviation|Mean
2621227|NCT01948947|Primary|Percent Change in Persistent Headache Prevalence|The persistent headache prevalence measure was assessed through a daily headache log over the course of the subjects participation in the study and collected at baseline, 1-week and 1-month. The persistent headache is defined as having had 3+ continuous headaches over the course of the time point periods and was coded as either yes or no. The results indicate the percent change in the prevalence of persistent headaches for the subjects at the time points. A larger reduction percent indicates a larger decrease in subjects with those persistent headaches.|Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured.||||percent change from baseline||Standard Deviation|Mean
2621228|NCT01948947|Primary|Percent Change in Persistent Headache Intensity|The persistent headache measure was assessed through a daily headache log over the course of the subjects participation in the study and averaged for the time point period of baseline, 1-week and 1-month results. The persistent headache is based on a scale of 0-10, the higher the persistent headache intensity averaged score the worse the persistent headache.|Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured and averaged.||||percent change from baseline||Standard Deviation|Mean
2621657|NCT01944059|Primary|Number of Migraine/Headache Days|The primary outcome measure will be the frequency of migraine and all headache days in the Theramine active group versus the Theramine placebo group during the treatment period.|4-6 months|Study funding ended prematurely. Blinding information not provided by Funder. Data analysis was not completed.||||||
2621229|NCT01948947|Primary|Percent Change in Composite Score of Debilitating Headache (Intensity x Duration x Frequency)|The primary outcome time-point measurement will be averaged from each day the subject is enrolled in the study for each of the 3 time point periods: pre-treatment baseline, 1-week follow-up and 1-month follow-up. The results depict change in the composite score: intensity (scale of 0-10) x duration (# of hours) x frequency (# headaches per week). The larger composite score for each subject, the worse the debilitating headaches.|Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured and averaged.||||percent change from baseline||Standard Deviation|Mean
2621230|NCT01948908|Secondary|Number of Patients With Physicians Who Were Satisfied or Very Satisfied With Ease of Medication Administration|This outcome is designed to examine MD satisfaction with ease of administration of intranasal medication - physicians who expressed that they were satisfied or very satisfied with ease of medication administration will be counted.|60 minutes||||participants|||Number
2621231|NCT01948908|Secondary|Observational Scale of Behavioral Distress - Revised|The Observational Scale of Behavioral Distress - revised (OSBD-r) is an eight-factor, weighted observational scale used to measure distress associated with medical procedures in children 1 to 20 years of age. The total OSBD-r score is the sum of the OSBD-r scores for predetermined clinically relevant phases of the procedure, with each phase assigned a score from 0 to 23.5 (0=no distress, 23.5=maximum distress), based on the frequency and types of behaviors observed during a pre-determined number of 15-second intervals during each phase.|60 minutes||||units||95% Confidence Interval|Mean
2621232|NCT01948908|Primary|Median Time (Minutes) After Administration of Intranasal Midazolam Until Patient Achieves Minimal Sedation|This outcome is designed to examine time to onset of minimal sedation, defined as a University of Michigan Sedation Score (UMSS) of 1.|20 minutes||||minutes||95% Confidence Interval|Median
2621233|NCT01948830|Secondary|Change From Baseline in Composite Score of the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25)|The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicates the best possible response. The composite score and score of each of each construct also ranged from 0 to 100 as they are calculated as total scores divided by the number of questions. The higher the values of total scores represent better outcome|Baseline, Month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and post-baseline value at the specific visit were included for this analysis|||Score on a scale||Standard Deviation|Mean
2621234|NCT01948830|Secondary|Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at|To evaluate presence of active CNV leakage on fluorescein angiography (FA) by reading center over time up to Month 12. The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the presence of leakage at study completion. These total counts are used as the denominator for the percentages.|Month 12|Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization.|||Percentage of participants|||Number
2621235|NCT01948830|Secondary|Change in Central Subfield Retinal Thickness (CSFT) Over Time|OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center. The Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit|Month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.|||microns||Standard Deviation|Mean
2621236|NCT01948830|Secondary|Percentage of Participants With Fluid Free Macula Over Time up to Month 12|OCT (optical coherence tomography) was used to assess intra-retinal fluid as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography). Fluid free macula refers to absence of macular edema (as assessed by the reading center). The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the macular edema (center involvement) at study completion. These total counts are used as the denominator for the percentages|Month 12|Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization|||Percentage of participants|||Number
2621237|NCT01948830|Secondary|The Average Number of Days Between Injections|The average dosing interval was measured as the average number of days between injections|Month 12|Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization|||days||Standard Deviation|Mean
2621238|NCT01948830|Secondary|The Mean Number of Treatment Frequency|The number of injections received|Month 12|Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization|||Number of injections||Standard Deviation|Mean
2621239|NCT01948830|Secondary|Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 12 indicates a positive outcome|Baseline and every month for 12 months|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.|||Number of participants|||Number
2622231|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5)||Visit 6 (Month 5)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||participants|||Number
2621240|NCT01948830|Secondary|Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit|Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.|Baseline and every month for 12 months|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.|||Number of participants|||Number
2621241|NCT01948830|Secondary|Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 12 as compared with baseline|Baseline and every month for 12 months|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis.|||Number of participants|||Number
2621242|NCT01948830|Secondary|Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and compare to Baseline|Baseline and every month for 12 months|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit.|||Letters (EDTRS)||Standard Deviation|Mean
2621243|NCT01948830|Secondary|Average BCVA Change From Baseline to Month 12|"Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.~Mean Visual Acuity was averaged over all monthly assessments from Baseline to Month 12"|Baseline and every month for 12 months|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and average visual acuity (VA) from month 1 to study completion were included in this analysis.|||Letters (EDTRS)||Standard Deviation|Mean
2621244|NCT01948830|Secondary|Change in BCVA From Baseline to Month 12|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters|Baseline to Month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and study completion after last observational carried forward (LOCF) were included in this analysis. LOCF was used as an imputation of missing data.|||Letters (EDTRS)||Standard Deviation|Mean
2621245|NCT01948830|Secondary|Number of Visits Scheduled|The number of visits scheduled according to the treat and extend regimen after treatment initiation|From Month1 to Month 11|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was analyzed.|||Number of visits||Standard Deviation|Mean
2621246|NCT01948830|Primary|Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement|Baseline to month 12|The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and study completion after last observational carried forward (LOCF) were included in this analysis. LOCF was used as an imputation of missing data.|||Letters (EDTRS)||Standard Error|Least Squares Mean
2621247|NCT01948791|Secondary|Change From Baseline in Caregiver Burden Inventory (CBI) Score|CBI, formulated by Novak and Guest in 1989, is a relatively complete and effective scale to measure caregiver burden that has been extensively adopted internationally. CBI has a total of 24 items in 5 domains, i.e., time dependency items (items 1-5), development items (items 6-10), physical health items (items 11-14), social relations items (items 15-18), and emotional heath items (items 19-24). Each item is scored on a 5-point scale based on the intensity of burden (0-4 points), so that the total score is 0-96, a higher score indicating heavier burden. It is a self-administered scale that takes about 10-15 minutes to complete. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated.|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window & had no major protocol violations.|||units on a scale||95% Confidence Interval|Mean
2621248|NCT01948791|Secondary|Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score|This scale assesses a larger scope of the behavior problems/disorders experienced in dementia patients, and identifies the frequency & severity of the behavior disorders, & allows rapid assessment using screening questions. 10 questions in behavior domain & 2 in autonomic nervous system domain were assessed by the investigator interviewing with the caregiver. The NPI-12 total score is the total score of the 12 items, among which the score for each domain is the product of frequency (range: 1-4 points) and severity (range: 1-3 points). The highest score for each domain is 12 points and all the domains have the same weight. Therefore the range of NPI-12 total score is 0-144 points. The NPI-10 total score is the total score of the first 10 items 0-120, which constitute the original form of this scale. A higher NPI total score indicates more severe behavior disorder. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated.|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window & had no major protocol violations.|||units on a scale||95% Confidence Interval|Mean
2621249|NCT01948791|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE)|MMSE was used to determine patient's eligibility to participate, is an easy & practical screening test to identify cognitive disorders. Test consists of 2 parts: language (time orientation, registration & attention) & performance (recall, response to written/verbal commands, writing ability & reproduction of complex polygons); total score range: 0-30; higher score = better function. Positive change score = improvement from baseline. To meet eligibility criteria, patient's MMSE total score at screening had to be 10-26 (inclusive). Interpretation of MMSE by 4 methods: Single Cut0ff: <24=abnormal; Range: <21=Increased odds of dementia; >25=Decreased odds of dementia; Education: 21- abnormal for 8th grade education, <23=abnormal for high school education, <24=abnormal for college education; Severity: 24-30=no cognitive impairment, 18-23=mild cognitive impairment, 0-17=severe cognitive impairment. 2-sided 95% CI of difference in means between baseline & post-baseline values were calculated|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window & had no major protocol violations.|||units on a scale||95% Confidence Interval|Mean
2621250|NCT01948791|Secondary|Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score|"ADCS-ADL is a scale based on caregiver's assessment of patient's activities of daily life. It is used in clinical studies on dementia & consists of 23 items and is designed to assess patient's basic & instrumental activities of daily life, such as the abilities necessary for personal care, communicating & interacting with other people, maintaining a household, conducting hobbies & interests, & making judgments & decisions. Response to each item is obtained by interview with the caregiver. The basic activities of daily life domain includes mandatory options for best response, or yes or no questions with separate sub-questions. Higher score & more yes answers indicate better level of self-care of patient. Therefore the higher the total score is, the better the patient's functions. The total score is the sum of the scores of all the items & sub-questions,& ranges from 0 to 78. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated."|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window & had no major protocol violations.|||units on a scale||95% Confidence Interval|Mean
2621251|NCT01948791|Primary|Mean Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog)|The Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) was used to measure change in cognitive function. Alzheimer's disease assessment scale (ADAS) is a scale to measure specific cognitive and behavior disorders in Alzheimer disease (AD) patients. The Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog) provides a total score range 0-70, and consists of 11 items with lower score indicating lighter impairment and higher total scores indicating more impairment. A negative change score indicates improvement from baseline. Two-sided 95% CI of the difference in the means between baseline and post-baseline values were calculated.|Baseline, Week 16|The Per Protocol (PP) population included all patients who had been enrolled to receive treatment, and who had received at least 1 dose of study drug, had 1 baseline assessment & at least 1 post-baseline efficacy assessment for primary efficacy variable within the Week 16 visit window, and had no major protocol violations.|||units on a scale||95% Confidence Interval|Mean
2621252|NCT01948518|Secondary|Change in 6 Minute Walk Distance|The change in 6 minutes walk distance from baseline one hour after receiving 20 mg of sildenafil orally will be measured.|Baseline and one hour||||feet||Standard Deviation|Mean
2621253|NCT01948518|Primary|Change in Diffusion Capacity Measured at Baseline and One Hour.|Determine the acute effect of oral sildenafil on diffusion capacity in patients with diffuse parenchymal lung disease and concomitant pulmonary hypertension|Baseline and one hour||||ml/min/mmHg||Standard Deviation|Mean
2621254|NCT01948388|Other Pre-specified|Participants With Increased and Decreased C-Reactive Protein (CRP) Values and Erythrocyte Sedimentation Rates (ESR)|comparisons not statistical analysis will be made from Baseline and Month 6 of the C- reactive Protein (CRP) values and Erythrocyte Sedimentation Rate (ESR) to determine the number of patients whose test result improved or worsenedCRP value (normal range <1.0 mg/dl). ESR (normal range 0-28 mm/hr) . If the value is increased, the disease activity worsened. If the value is reduced the disease activity is improved.|Month 6|Total number of Patients who complete 6 months of treatment in both groups doses weekly Group 1, and dosed twice a week Group 2|||Participants|||Count of Participants
2621255|NCT01948388|Secondary|Comparison of Clinical Disease Activity Index (CDAI) Scores to Positive Magnetic Resonance Imaging (MRI) Findings|"Comparison of the clinical findings as measured by the Clinical Disease Activity Index (CDAI) versus the structural findings as measured by Magnetic Resonance Imaging (MRI). Improvement is measured as a reduction in CDAI score from Baseline to Month 6 and improvement in MRI is regression of erosions, oseitis and synovitis at month 6. Norman MRI score is zero (0).~CDAI: 0.0-2.8 remission; 2.9-10.0 low disease activity; 10.1-22 moderate disease activity; 22.1-76 high disease activity. A decrease in CDAI score is improvement"|Month 6|Total number of Patients who complete 6 months of treatment in both groups doses weekly Group 1, and dosed twice a week Group 2|||participants|||Number
2621256|NCT01948388|Secondary|Number of Participants With Increased or Decreased Erosions of the Hand and Wrist|"Comparison of the change in the number of erosions seen in the joints of the hand and wrist as measured by Magnetic Resonance Imaging (MRI) findings.~Regression indicates improvement in the number of erosions seen from Baseline and Progression indicates worsening in the number of erosions seen from Baseline. Normal range is zero (0)."|Month 3 and Month 6|Total number of Patients with erosions who completed 6 months of treatment in both groups doses weekly Group 1, and dosed twice a week Group 2|||participants|||Number
2621257|NCT01948388|Secondary|Evaluation of MRI Structural Improvements|To compare the number of patients who have synovitis, oseitis and erosions at Baseline, Month 3 and Month 6. Normal range for synovitis, osteitis and erosions is zero (0)|Baseline, 3 months, 6 months|Total number of Patients who complete 6 months of treatment in both groups doses weekly Group 1, and dosed twice a week Group 2|||participants|||Number
2622184|NCT01941030|Primary|Change in Plaque Area as Assessed by IVUS|The pre- (Pre-Tx) and post-treatment (Post-Tx) plaque area. A positive value equates to a decrease in plaque area.|Pre-intervention, and post-balloon angioplasty|Not all subjects had reported IVUS data for each lesion pre- and post-treatment.|||area (mm^3/mm)|lesions|Inter-Quartile Range|Median
2621258|NCT01948388|Primary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score|To evaluate the effect of the use of 2 doses of corticotrophin (ACTH) as a treatment in patients with early onset rheumatoid arthritis as an alternative to conventional steroid therapy by evaluating the change from baseline in the clinical findings as measured by Clinical Disease Activity Index (CDAI) scores. The CDAI is calculated at the specified time points using the formula: CDAI = SJC(28) + TJC(28) + PGA + EGA SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees) Interpretation: A lower CDAI score from Baseline would mean improvement in disease activity and an increase in CDAI score from Baseline would mean an increase in disease activity or a worsening in disease activity. Scores: 0.0-2.8 = Range for Remission; 2.9-10.0 = Range for Low disease activity; 10.1-22.0 Range for Moderate disease activity; 22.1-76 Range for High disease activity.Total range is from 0-100, with the high scores representing high disease activity.|Baseline, Month 3 and Month 6|Total number of Patients who complete 6 months of treatment in both groups doses weekly Group 1, and dosed twice a week Group 2|||Participants|||Count of Participants
2621259|NCT01948375|Secondary|Acceptability of the Acupuncture Needle|"After the third acupuncture of each period, participants are asked to show their acceptance toward the needles with a 5-point scale: very difficult to accept, a little difficult to accept, acceptable, easy to accept, very easy to accept.~The needle acceptability between the placebo needle and real needle are compared.~Data of the acceptability of the placebo needle included rows 1-5, i.e., rows of placebo needle: very difficult to accept, placebo needle: a little difficult to accept, placebo needle: acceptable, placebo needle: easy to accept and placebo needle: very easy to accept.~Data of the acceptability of the real needle included rows 6-10, i.e., rows of real needle: very difficult to accept, real needle: a little difficult to accept, real needle: acceptable, real needle: easy to accept and real needle: very easy to accept."|in the third acupuncture session in each period||||participants|||Number
2621260|NCT01948375|Secondary|Degree of Acupuncture Pain|"The pain of acupuncture is assessed using visual analogue scale (VAS), where 0 means no pain, and 10 means the imaginable severest pain. The VAS value of each period is used to compare the difference of acupuncture pain between the placebo needle and the real needle.~A lower value represented a better outcome, which indicated that needles used induced less pain."|in the third acupuncture session in each period||||units on a scale||Standard Deviation|Mean
2621261|NCT01948375|Secondary|Southampton Needle Sensation Questionnaire—Degree of Needle Sensation|"The degree of needle sensation between the placebo needle and the real needle were compared.~The data of degree of needle sensation of the placebo needle included rows 1-4,i.e,, rows of placebo needle:no, placebo needle: mild, placebo needle: moderate and placebo needle: severe.~The data of degree of needle sensation of the real needle included rows 5-8, i.e., rows of real needle: no, 'real needle: mild, real needle: moderate, and real needle: severe."|in the third acupuncture session in each period||||participants|||Number
2621262|NCT01948375|Secondary|Southampton Needle Sensation Questionnaire—Type of Needle Sensation|This questionnaire is used to collect the types and degree of needle sensation experienced by participants. Information is collected after the third acupuncture session in each period. The difference between two kinds of needles is to be analyzed.|in the third acupuncture session in each period||||participants|||Number
2621263|NCT01948375|Primary|Proportion of Volunteers'Perception of Needle Penetration Between the Pragmatic Placebo Needle and Real Needle.|"The primary outcome was the proportion of volunteers'perception of needle penetration between the placebo needle and the real needle in the third acupuncture session in each period.~LI4, on the dorsum of the hand, between the first and second metacarpal bones, approximately in the center of the second metacarpal bone; RN12, on the upper abdomen,4 cun above the umbilicus,on the anterior midline; BL36, on the back of the thigh,on the midpoint of the inferior gluteal crease; BL25, on the loin, 1.5 cun lateral to the lower border of the spinous process of the fourth lumbar vertebra."|in the third acupuncture session in each period||||participants|||Number
2621264|NCT01948310|Secondary|Change in Total Daily Energy Expenditure|Total daily physical activity is measured via Actigraph GT3X accelerometers. Accelerometers will be worn for 7 days pre-drug, post-drug/pre-exercise (week 4) and again in the final month of the exercise intervention (week 13)|Week 1, Week 4 and Week 14|Subjects who completed the study were included in the analysis.|||kj/hr||Standard Deviation|Mean
2621265|NCT01948310|Secondary|Change in Treatment Satisfaction as Measured by the Seattle Angina Questionnaire|The Treatment Satisfaction scale is one of five scales of the Seattle Angina Questionnaire. The possible range of scores is 0 to 100, with higher scores indicating better quality of life.|Baseline, Week 2 and Week 14|Subjects who completed the study were included in the analysis|||units on a scale||Standard Deviation|Mean
2621266|NCT01948310|Primary|Change in Peak Oxygen Consumption (VO2 Max)|This test involves exercising on a treadmill or bike to maximal exertion, during which the subject's breathing and oxygen consumption are measured. Under a set study protocol, treadmill or bike workload will increase every minute until the participant either chooses to end the test or the study personnel choose to end the test for safety purposes.|Baseline, Week 2 and Week 14|Subjects who completed the study were included in the analysis|||ml/kg/min||Standard Deviation|Mean
2621267|NCT01948258|Other Pre-specified|Pregnancy Test Result|Pregnancy test results will also be compared with both the performance of a currently marketed pregnancy test when used by a trained technician and quantitative hCG concentration.|one month|Volunteers who completed the study, comparison of Clearblue Fertility Monitor pregnancy test results and a marketed pregnancy test. Results for all tests conducted.|||percentage of tests in agreement||95% Confidence Interval|Number
2621268|NCT01948258|Secondary|Correct Identification of Monitor Status|To demonstrate correct user identification of fertility status and test days and to determine the performance of the monitor in consumer hands.|one month|Volunteers who completed the study, who had daily diary entries and monitor download data for days on which a test was conducted|||percentage of participants|||Number
2621269|NCT01948258|Primary|The Ability of the Volunteer to Use the New Clearblue Advanced Fertility Monitoring a Home Setting|Acceptance criteria is that ≥80% of volunteers will score 3 or less on the Likert scale in a home setting by demonstrating ease of use and comprehension of the instructions for use.|one month use|Volunteers whose data contributes to the full analysis set.|||percentage of participants|||Number
2624511|NCT01923480|Secondary|Plasma Concentration of Aspartic Acid||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
2621270|NCT01948193|Primary|Percentage of Participants With Vaccine Response After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|Anti-pertussis toxin (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured with an ELISA. Vaccine response was defined as percentage of participants with post-dose 3 anti-PT and anti-FHA antibody concentrations in ELISA units (EU)/mL ≥ 4 x Lower Limit of Quantification (LLOQ) if pre-vaccination concentration was < 4 x LLOQ or ≥ pre-vaccination concentration if pre-vaccination concentrations ≥ 4 x LLOQ.|Pre-dose 1 to one month post-dose 3|Vaccine response was assessed in the Per-protocol Analysis Set.|||Percentage of participants|||Number
2621271|NCT01948193|Secondary|Percentage of Participants Reporting Solicited Injection-site or Systemic Reaction After Each Vaccination With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of Oral Poliovirus and Recombinant Hep B Vaccine at Birth|Injection-site reactions: Tenderness, Erythema, and Swelling. Systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Injection site reactions: Tenderness, Cries when injected limb is moved, or reduced movement of injected limb; Erythema and Swelling, ≥50 mm. Grade 3 Systemic reactions: Fever, >39.5°C or >103.1°F; Vomiting, ≥6 episodes/24 hours or requires parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time/difficult to wake up; Appetite lost, Refuses ≥3 or most feeds/meals; Irritability, Inconsolable.|Within 7 days after each vaccine injection|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.|||Percentage of participants|||Number
2621272|NCT01948193|Secondary|Geometric Mean Titer Ratios of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|Diphtheria antibodies were measured by a toxin neutralization test, PT and FHA antibodies by an ELISA, and Hep B antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.|Pre-dose 1 to one month post-dose 3|Geometric mean titer ratios were assessed in the Per-protocol Analysis Set.|||Titer ratio||95% Confidence Interval|Geometric Mean
2621273|NCT01948193|Secondary|Geometric Mean Titers of Antibodies Against Vaccine Antigens After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine After a Documented Dose of an Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|Diphtheria antibodies were measured by a toxin neutralization test, tetanus, PT, and FHA antibodies by an ELISA, PRP antibodies by a Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hep B antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.|Pre-dose 1 to one month post-dose 3|Geometric mean titers were assessed in the Per-protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2621274|NCT01948193|Primary|Percentage of Participants With Seroprotection After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|"Diphtheria antibodies were measured by a toxin neutralization test, tetanus antibodies by an enzyme-linked immunosorbent assay (ELISA), Haemophilus influenzae type b polysaccharide (PRP) antibodies by Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.~Description of seroprotection: Diphtheria and Tetanus antibody concentrations ≥0.01 International Units (IU)/mL; Poliovirus 1, 2, and 3 titers ≥8 (1/dilution); Hep B concentrations ≥10 mIU/mL, and PRP ≥0.15 µg/mL."|Pre-dose 1 to one month post-dose 3|Seroprotection was assessed in the Per-protocol Analysis Set.|||Percentage of participants|||Number
2621275|NCT01948193|Secondary|Percentage of Participants With Seroprotection Before and After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial Oral Poliovirus Vaccine and Recombinant Hep B Monovalent Vaccine at Birth|"Diphtheria antibodies were measured by a toxin neutralization test, tetanus antibodies by an enzyme-linked immunosorbent assay (ELISA), Haemophilus influenzae type b polysaccharide (PRP) antibodies by Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System.~Description of seroprotection: Diphtheria and Tetanus antibody concentrations ≥0.01 International Units (IU)/mL; Poliovirus 1, 2, and 3 titers ≥8 (1/dilution); Hep B concentrations ≥10 mIU/mL, and PRP ≥0.15 µg/mL."|Pre-dose 1 to one month post-dose 3|Seroprotection was assessed in the Per-protocol Analysis Set.|||Percentage of participants|||Number
2621276|NCT01948141|Secondary|Progression Free Survival|Progression-free survival (PFS) was defined as the time from study entry to the first of either disease progression or death.|Time from study entry to the first of either disease progression or death, assessed up to 3 years|All treated patients|||months||95% Confidence Interval|Median
2621277|NCT01948141|Secondary|Incidence of Adverse Events (AEs)|Percentage of participants with adverse events. Incidence of Adverse Events (AEs) was Accessed by the National Cancer Institute (NCI) CTCAE Version 4.0.|Up to 30 days post-treatment|All treated and eligible patients. No statistics computed due to all patients had AEs in both groups.|||percentage of participants||95% Confidence Interval|Number
2621278|NCT01948141|Secondary|Tumor Response Rate|Tumor Response rate was defined as the proportion of patients who had Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria. Complete Response (CR): Disappearance of all target lesions. Any lymph nodes must have a reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Up to 3 years|All treated and eligible patients. No statistics computed due to all patients were non-response in both groups.|||percentage of participants||95% Confidence Interval|Number
2621279|NCT01948141|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from study entry to death from any cause.|From study entry to death from any cause, assessed up to 3 years||||months||95% Confidence Interval|Median
2621280|NCT01948141|Secondary|6-month PFS Rate for Each of the FGFRI Amplified Groups (Low, Intermediate, High) in Comparison to Historical Controls|The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment.|Time from study entry to the first of either disease progression or death, assessed at 6 months|No comparison was done do versus historical controls because it was inappropriate due to the small number of patients available.||||||
2621281|NCT01948141|Secondary|Compare the 6-month PFS Rate for Each FGFR1 Amplified Group (Low, Intermediate, and High) Versus FGFR1 Non-amplified Patients.|The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment.|Time from study entry to the first of either disease progression or death, assessed at 6 months|All treated and eligible patients. One participant was not done due to not enough tissue.|||percentage of participants|||Number
2621282|NCT01948141|Secondary|Compare the 6-month PFS Rate for the Entire FGFR1 Amplified Group Versus the FGFR1 Non-amplified Patients.|The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment.|Time from study entry to the first of either disease progression or death, assessed at 6 months|All treated and eligible patients. One participant was not done due to not enough tissue.|||percentage of participants|||Number
2621283|NCT01948141|Primary|6-month Progression Free Survival (PFS) Rate Within the Entire FGFR1 Amplified Group|The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|At 6 months|All patients in FGFR1 amplified group|||percentage of participants||95% Confidence Interval|Number
2621284|NCT01948076|Secondary|Improvement in Diagnostic Ability Within the Intervention Group|"For the secondary outcome, we assessed whether there was an improvement in the diagnostic ability of those in the intervention group using traditional physical examination techniques as compared to using the ultrasound device. We compared the two arms using the average physical findings correctly identified as present or absent as reflected by a Present Score (average # of findings identified out of 17 possible findings) and Absent Score (average # of findings identified out of 95 possible). The residents used a examination form to indicate whether or not they felt the physical abnormality was present or absent using their physical exam alone and then again after using the ultrasound. This was compared with the gold standard which was presence or absence of the abnormality on professional ultrasound."|one month||||units on a scale||Inter-Quartile Range|Mean
2621285|NCT01948076|Primary|Comparison of Diagnostic Ability of the Intervention Group's Ultrasound Exam to the Control Group's Physical Exam|"The primary outcome is a comparison of the diagnostic ability of the intervention group as recorded after performing an ultrasound exam and the control group using traditional physical examination techniques. We compared the two groups using the average physical findings correctly identified as present or absent as reflected by a Present Score (average # of findings identified out of 17 possible findings) and Absent Score (average # of findings identified out of 95 possible). The former is a gauge of a resident's ability to correctly identify present abnormalities while the latter is an assessment of correctly identifying a normal examination when findings are absent. The residents used a examination form to indicate whether or not they felt the physical abnormality was present or absent and how confident he or she was in their answer. This was compared with the gold standard which was presence or absence of the abnormality on professional ultrasound."|one month|All residents were analyzed. There was one withdrawal due to family emergency|||units on a scale||Inter-Quartile Range|Mean
2621286|NCT01948063|Primary|CoQ10 Levels|Total CoQ10 levels (mcg/mL) at 24 hours post study drug admission.|24 hours after study drug administration||||(mcg/mL)||Inter-Quartile Range|Median
2621287|NCT01948050|Primary|Pain Intensity|"Measured on the 11 point numerical paid rating scale with anchor points 0 = no pain and 10 = worst pain possible. The outcome measure Pain intensity assessed as a change between baseline and post tDCS stimulation (after stimulation day 5). The calculated change in the range of positive numbers indicates decreased pain intensity post-treatment (eg. baseline 6; post treatment 4; change +2 indicating decrease of pain intensity by 2 points). Similarly, change in range of negative numbers indicates a worsening of pain intensity (eg. baseline 6; post treatment 8; change -2)."|Assessed at baseline and post tDCS stimulation day 5||||Points on numerical rating scale||Standard Error|Mean
2621288|NCT01947946|Primary|Asthma Exacerbations Over 48 Weeks Treatment|The number of asthma exacerbations over 48 weeks treatment will be counted|48 weeks treatment|Patients from the full analysis set will be used. All patients randomized and receiving any investigational product will be included in the full analysis set, irrespective of their protocol adherence and continued participation in the study.|||Number of events|||Number
2621289|NCT01947907|Secondary|Annualized Height Velocity|Annualized HV during treatment with ACP-001 or daily rhGH at the end of 6 months, for each ACP-001 dose group and for the daily rhGH dose group|Baseline to 6 months (Visit 5)||||cm/year||Standard Deviation|Mean
2621290|NCT01947907|Primary|AUEC0-168h of IGF-1|"As part of the following endpoint:~PD profile of serum IGF-1 during V1 and V3 compared between the ACP-001 dose groups and to the rhGH group.~Uncorrected AUEC0-168 (area under the efficacy curve from 0h-168h) values at Week 13"|0 hours to 168 hours at Visit 3 (Week 13)||||h*ng/mL||Standard Deviation|Mean
2621291|NCT01947907|Primary|Emax of IGF-1|"As part of the following endpoint:~PD profile of serum IGF-1 during V1 and V3 compared between the ACP-001 dose groups and to the daily rhGH group"|0 hours to 168 hours at Visit 3 (Week 13)||||ng/mL||Standard Deviation|Mean
2621292|NCT01947907|Primary|E-Trough of IGF-1|"As part of the following endpoint:~PD profile of serum IGF-1 during Visit 1 and Visit 3 compared between the ACP-001 dose groups and to the daily rhGH group~Uncorrected E-Trough (the pre-dose efficacy response) values at Week 13"|0 hours to 168 hours at Visit 3 (Week 13)||||ng/mL||Standard Deviation|Mean
2621293|NCT01947907|Primary|AUC0-168h of hGH|"As part of the following endpoint:~PK profile of serum hGH from ACP-001 treated patients compared between ACP-001 dose groups and to the PK profile of hGH from the daily rhGH group during Visit 1 and Visit 3~Uncorrected AUC0-168h (area under the curve from 0h to 168h) values at Visit 3 (Week 13)"|0 hours to 168 hours at Visit 3 (Week 13)||||h*ng/mL||Standard Deviation|Mean
2621294|NCT01947907|Primary|Cmax of hGH|"As part of the following endpoint:~PK profile of serum hGH from ACP-001 treated patients compared between ACP-001 dose groups and to the pharmacokinetic (PK) profile of hGH from the daily rhGH groups during visit 1 and 3.~Uncorrected Cmax (maximum value of concentration) values at Visit 3 (Week 13)"|0 hours to 168 hours at Visit 3 (Week 13)||||ng/mL||Standard Deviation|Mean
2621295|NCT01947907|Primary|Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator)|Assessment of local tolerability was performed by examining injection sites (by the investigator during study visits) and on the basis of anamnestic data and records in the Patient Diary. Assessments included pain, redness, bruising, swelling, and itching. Every subject was counted only once within each symptom category.|Start of study treatment through Visit 5 (Week 27)||||Number of subjects with any symptom|||Number
2621296|NCT01947907|Primary|Incidence of Anti-hGH Neutralizing Antibody Formation|Number of subjects with positive results for anti-hGH neutralizing antibodies at two consecutive post-dose visits|Visit 2 - Visit 5||||participants|||Number
2621297|NCT01947907|Primary|Incidence of Anti-hGH Binding Antibody Formation|Number of subjects with positive results for anti-hGH binding antibodies at two consecutive post-dose visits|Visit 2 - Visit 5|Safety analysis set includes all patients who receive at least one dose of planned study medication|||participants|||Number
2621298|NCT01947894|Secondary|Percentage of Participants With Any Concomitant Medication at Baseline and During Follow-up|Percentage of participants taking any medications other than Genotropin (concomitant medication) are reported.|Baseline, Follow-up (during 28 days after last dose of Genotropin treatment)|All participants who were enrolled in the study.|||percentage of participants|||Number
2621299|NCT01947894|Secondary|Percentage of Participants With Any Change From Baseline in Hormone Abnormalities at Years 1, 2, 3, and 4|Hormones that were evaluated were thyroid stimulating hormone, adrenocorticotropic hormone, luteinizing hormone, follicle-stimulating hormone, antidiuretic hormone and prolactin hormone. Abnormalities were judged by the investigator.|Baseline, Year 1, 2, 3, 4|FAS was analyzed. Here, “Number analyzed” = participants who were evaluable at specified time points for each arm, respectively.|||percentage of participants|||Number
2621300|NCT01947894|Secondary|Percentage of Participants With Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Investigation at Baseline, Years 1, 2, 3, 4 and 5|CT is a diagnostic imaging test used to create detailed images of internal organs, bones, soft tissue and blood vessels. MRI investigation uses strong magnetic field and radio waves to create detailed images of the organs and tissues within the body.|Baseline, Year 1, 2, 3, 4, 5|FAS was analyzed. Here, “Number analyzed” = participants who were evaluable at specified time points for each arm, respectively.|||percentage of participants|||Number
2621301|NCT01947894|Secondary|Percentage of Participants With Body Composition Assessments at Baseline, Years 1, 2, 3 and 4|Body composition included parameters fat mass and muscle mass.|Baseline, Year 1, 2, 3, 4|FAS was analyzed. Here, “Number analyzed” = participants who were evaluable at specified time points for each arm, respectively.|||percentage of participants|||Number
2621302|NCT01947894|Secondary|Change From Baseline in Heart Rate of Participants at Years 1, 2, 3, 4 and 5|Heart rate was measured in supine position.|Baseline, Year 1, 2, 3, 4, 5|FAS was analyzed. Here, “Number analyzed” = participants who were evaluable at specified time points for each arm, respectively.|||bpm||Standard Deviation|Mean
2621303|NCT01947894|Secondary|Heart Rate of Participants at Baseline, Years 1, 2, 3, 4 and 5|Heart rate was measured in supine position.|Baseline, Year 1, 2, 3, 4, 5|FAS was analyzed. Here, “Number analyzed” = participants who were evaluable at specified time points for each arm, respectively.|||beats per minute (bpm)||Standard Deviation|Mean
2621304|NCT01947894|Secondary|Change From Baseline in Blood Pressure of Participants at Years 1, 2, 3, 4 and 5|Measurement of BP included supine SBP and DBP.|Baseline, Year 1, 2, 3, 4, 5|FAS was analyzed. Here, “Number analyzed” = participants who were evaluable at specified time points for each arm, respectively.|||mmHg||Standard Deviation|Mean
2621305|NCT01947894|Secondary|Blood Pressure (BP) of Participants at Baseline, Years 1, 2, 3, 4 and 5|Measurement of BP included supine systolic blood pressure (SBP) and diastolic blood pressure (DBP).|Baseline, Year 1, 2, 3, 4, 5|FAS was analyzed. Here, “Number analyzed” = participants who were evaluable at specified time points for each arm, respectively.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2621306|NCT01947894|Secondary|Change From Baseline in Body Mass Index of Participants at Years 1, 2, 3, 4 and 5|BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in m^2.|Baseline, Year 1, 2, 3, 4, 5|FAS was analyzed. Here, “Number analyzed” = participants who were evaluable at specified time points for each arm, respectively.|||kg/m^2||Standard Deviation|Mean
2621307|NCT01947894|Secondary|Body Mass Index (BMI) of Participants at Baseline, Years 1, 2, 3, 4 and 5|BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m^2).|Baseline, Year 1, 2, 3, 4, 5|FAS was analyzed. Here, “Number analyzed” = participants who were evaluable at specified time points for each arm, respectively.|||Kilogram per meter squared (kg/m^2)||Standard Deviation|Mean
2621308|NCT01947894|Secondary|Change From Baseline in Height of Participants at Years 1, 2, 3, 4 and 5|Height of participants was measured in centimeters.|Baseline, Year 1, 2, 3, 4, 5|FAS was analyzed. Here, “Number analyzed” = participants who were evaluable at specified time points for each arm, respectively.|||centimeters (cm)||Standard Deviation|Mean
2621309|NCT01947894|Secondary|Height of Participants at Baseline, Years 1, 2, 3, 4 and 5|Height of participants was measured in centimeters.|Baseline, Year 1, 2, 3, 4, 5|FAS was analyzed. Here, “Number analyzed” = participants who were evaluable at specified time points for each arm, respectively.|||centimeters (cm)||Standard Deviation|Mean
2621310|NCT01947894|Secondary|Change From Baseline in Weight of Participants at Years 1, 2, 3, 4 and 5|Weight of participants was measured in kg.|Baseline, Year 1, 2, 3, 4, 5|FAS was analyzed. Here, “Number analyzed” = participants who were evaluable at specified time points for each arm, respectively.|||kg||Standard Deviation|Mean
2621311|NCT01947894|Secondary|Weight of Participants at Baseline, Years 1, 2, 3, 4 and 5|Weight of participants was measured in kilograms (kg).|Baseline, Year 1, 2, 3, 4, 5|FAS was analyzed. Here, “Number analyzed” = participants who were evaluable at specified time points for each arm, respectively.|||kg||Standard Deviation|Mean
2621322|NCT01947816|Primary|Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions|Adverse drug reactions are defined as adverse events for which the causal relation with Humira cannot be ruled out. Serious adverse drug reactions are adverse drug reaction(s) which have been assessed to be serious based on company criteria.|Up to Week 52|Safety Analysis Set|||Participants|||Count of Participants
2621312|NCT01947894|Secondary|Number of Participants Who Discontinued Study Due to Adverse Events|An AE is any untoward medical occurrence in a participant administered a medicinal product that need not necessarily have a causal relationship with the product treatment or usage. An SAE is any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that resulted to death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); and congenital anomaly/birth defect. Participants who discontinued study due to AEs were reported.|Baseline up to 5 years|Safety analysis set included all enrolled participants who received at least 1 dose of Genotropin.|||Participants|||Count of Participants
2621313|NCT01947894|Secondary|Number of Adverse Events Leading to Withdrawal of Genotropin Treatment|An AE is any untoward medical occurrence in a participant administered a medicinal product that need not necessarily have a causal relationship with the product treatment or usage. An SAE is any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that resulted to death, life-threatening, hospitalization or prolongation of hospitalization, persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); and congenital anomaly/birth defect.|Baseline up to 5 years|Safety analysis set included all enrolled participants who received at least 1 dose of Genotropin. “Overall Number of Participants Analyzed” = number of participants evaluable for this outcome measure.|||adverse events|||Number
2621314|NCT01947894|Secondary|Number of Treatment Related Adverse Events|Treatment-related AEs refer to AEs that have a causal relationship with the treatment or usage. If there was any relationship between AE and Genotropin treatment,that was judged by investigator.|Baseline up to 5 years|Safety analysis set included all enrolled participants who received at least 1 dose of Genotropin. “Overall Number of Participants Analyzed” = number of participants evaluable for this outcome measure.|||adverse events|||Number
2621315|NCT01947894|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received Genotropin without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious AEs.|Baseline up to 5 years|Safety analysis set included all enrolled participants who received at least 1 dose of Genotropin.|||Participants|||Count of Participants
2621316|NCT01947894|Primary|Number of Participants Classified According to Insulin-like Growth Factor (IGF-I) Assessments|IGF-I along with growth hormone helps promote normal bone and tissue growth and development. Categories for assessment for participant's post-baseline IGF-I values: (1) IGF-I LLN = if any of assessments of IGF-I post-baseline visit was lower than lower limit of normal (LLN); (2) IGF-I ULN = If any of assessments of IGF-I post-baseline visit was greater than upper level of normal (ULN); (3) IGF-I unknown = no IGF-I reported; (4) Within reference range = IGF-I levels within normal range. Following is normal reference range of IGF-I in nanogram per milliliter. 18 Years of age (Y): Male =162-541, Female =170-640; 19 Y: Male =138-442, Female =147-527; 20 Y: Male =122-384,Female =132-457; 21-25 Y=116-341; 26-30 Y=117-321; 31-35 Y=113-297; 36-40 Y=106-277; 41-45 Y =98-261; 46-50 Y=91-246; 51-55 Y=84-233; 56-60 Y=78-220; 61-65 Y=72-207; 66-70 Y=67-195; 71-75 Y=62-184; 76-80 Y=57-172; >80 Y=53-162. There was no differentiation for male and female in normal range of IGF-I after 20 years of age.|Up to 5 years (after baseline visit)|Full analysis set (FAS) included all correctly enrolled participants who received at least 1 dose of Genotropin. Erroneously enrolled participants were excluded from FAS, as they did not meet the inclusion criteria or met an exclusion criterion, which was discovered after enrolment to the study.|||Participants|||Count of Participants
2621317|NCT01947855|Primary|Change in Area Under the Concentration-time Curve (AUC1-4h) for Postprandial Plasma Glucose From Baseline After 28 Days of Treatment|The primary endpoint is the change in AUC1-4h for postprandial plasma glucose based on meal tolerance test from baseline after 28 days of treatment. Baseline refers to the last observation prior to administration of randomised study medication.|1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day -1 (baseline), and 1h, 1.5h, 2h, 2.5, 3h, 3.5h and 4h after drug administration at day 28|Full analysis set|||mg*h/dL||Standard Error|Least Squares Mean
2621318|NCT01947816|Secondary|Change From Baseline in Partial Mayo Score Over Time|The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Partial Mayo score indicates improvement.|Weeks 4, 8, 16, 24, 52, when discontinued (up to Week 52), at final assessment (up to Week 52)|participants with an assessment at given time point|||score on a scale||Standard Deviation|Mean
2621319|NCT01947816|Secondary|Mayo Endoscopic Sub-Score Over Time|The endoscopist evaluated each observed segment of the colon (rectum, sigmoid, descending colon, transverse colon, ascending colon/cecum) by using the classification as follows: 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration).|Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52)|participants with an assessment at given time point|||Participants|||Count of Participants
2621320|NCT01947816|Secondary|Change From Baseline in Mayo Score Over Time|The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.|Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52)|participants with an assessment at given time point|||score on a scale||Standard Deviation|Mean
2621321|NCT01947816|Secondary|Change From Baseline in CRP Levels Over Time||Weeks 4, 8, 24, 52 of study drug administration, and at study drug discontinuation (up to Week 52)|Participants with an assessment at given time point|||mg/dL||Standard Deviation|Mean
2621323|NCT01947647|Primary|IIRS|The IIRS (Devin et al., 1983) is a 13-item scale that assesses the extent to which a disease interferes with important domains of life. Each item is rated on a 7-point Likert scale, ranging from 1 (not very much) to 7 (very much), with a total score range of 13-91. Although norms are not available for all diagnoses given the transdiagnostic nature of the IIRS, higher scores are indicative of greater impairment. The IIRS has strong psychometric properties in the previous literature in participants with physical and/or emotional health concerns (Devins et al., 2001; Devins, 2010).|baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)|Patient assigned to psychotherapy triage appointment within the MHC CBT Clinic.|||score on a scale||Standard Deviation|Mean
2621324|NCT01947647|Primary|STICSA-Somatic|The STICSA-Somatic (Ree et al., 2008) is a 10-item measure designed to assess trait somatic anxiety. Items are rated on a 4-point scale, ranging from 1 (not at all) to 4 (very much so), with a total score range of 10-40. Higher scores indicative of greater symptom severity, with scores above 18 considered of clinical significance. The somatic scale have been supported by factor analysis and has been found to have high internal consistency (alphas > .87; Gros et al., 2007; 2010).|baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)|43 participants dropped out of treatment|||score on a scale||Standard Deviation|Mean
2621325|NCT01947647|Primary|STICSA-Cognitive|The STICSA-Cognitive (Ree et al., 2008) is a 11-item measure designed to assess trait cognitive anxiety. Items are rated on a 4-point scale, ranging from 1 (not at all) to 4 (very much so), with a total score range of 11-44. Higher scores are indicative of greater symptom severity, with scores above 23 considered of clinical significance. The cognitive scale have been supported by factor analysis and has been found to have high internal consistency (alphas > .87; Gros et al., 2007; 2010).|baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)|43 participants dropped out of treatment|||score on a scale||Standard Deviation|Mean
2621326|NCT01947647|Primary|DASS-Stress|The DASS-Stress (Lovibond and Lovibond, 1995) is a 7-item measure designed to assess symptoms of tension and agitation. Items are rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale (range 0-21). Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance. Support for the factor structure, convergent and discriminant validity, and internal consistency has been found in community (Lovibond and Lovibond, 1995).|baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)|43 participants dropped out of treatment|||score on a scale||Standard Deviation|Mean
2621327|NCT01947647|Primary|DASS-Anxiety|The DASS-Anxiety (Lovibond and Lovibond, 1995) is a 7-item measure designed to assess symptoms of fear and autonomic arousal. Items are rated on a 4-point scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale (range 0-21). Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance. Support for the factor structure, convergent and discriminant validity, and internal consistency has been found in community (Lovibond and Lovibond, 1995).|baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)|43 participants dropped out of treatment|||score on a scale||Standard Deviation|Mean
2621328|NCT01947647|Primary|DASS-Depression|The DASS-Depression (Lovibond and Lovibond, 1995) is a 7-item measure designed to assess dysphoric mood. Items are rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale (range 0-21). Higher scores are indicative of greater symptom severity, with scores greater than 10 typically considered of clinical significance. Support for the factor structure, convergent and discriminant validity, and internal consistency of the DASS has been found in community (Lovibond and Lovibond, 1995).|baseline, immediate post-treatment (after session 12 complete), 6-month follow-up (after session 12 complete)|43 participants dropped out of treatment|||score on a scale||Standard Deviation|Mean
2621329|NCT01947582|Secondary|Number of Persons With Change in Muscle Activity Using Surface Electromyography (EMG)|Surface EMG is done on key muscles in the lower extremity (quadriceps, anterior tibialis, gastrocnemius, soleus) during computerized gait assessment. Changes in amplitude of muscle activity or timing of muscle activity would indicate, for example, increases in strength or changes in timing of muscles which might indicate motor learning as a result of wearing the ankle foot orthosis.|Assessed at visit 2 (week 1) and week 24||||persons|||Number
2621330|NCT01947582|Secondary|Change in Step Length Using the GAITRite Computerized Gait Analysis System|Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor.|Assessed at visit 2 (week 1) and week 24||||cm|||Number
2621331|NCT01947582|Secondary|Change in Impact of MS on Fatigue Using the 12-Item Walk Scale|The 12-Item Walk Scale is a paper and pencil test that asks persons with MS to rate their level of fatigue when doing functional tasks. The maximum possible score is 60 points and the lowest possible score is 12. Higher scores indicate a greater impact on walking than lower scores.|Assessed at visit 2 (week 1) and week 24||||difference of sum of score|||Number
2621332|NCT01947582|Primary|Change in Walking Distance During 6-Minute Walk Test|Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary. They will be asked to rate their level of exertion upon completion of walking on the rate of perceived exertion scale.|Assessed at visit 2 (week 1) and week 24||||feet|||Number
2621333|NCT01947517|Secondary|Tear Meniscus Height|Meniscus height measured in mm|6 months||||mm||Standard Deviation|Mean
2621334|NCT01947517|Secondary|National Eye Institute Grading for Conjunctival Staining|The conjunctival staining is divided into 6 zones. Each zone received a score for staining with lissamine green. Grade 0= no staining, grade 1= trace staining, grade 2= mild staining, grade 3= moderate staining, grade 4= severe staining. Data from different zones was combined and the total value was averaged.|6 months||||Scores on a scale||Standard Deviation|Mean
2621335|NCT01947517|Secondary|National Eye Institute Corneal Fluorescein Staining Pattern|The cornea is divided into 5 zones, and the inferior zone 5 was assessed for staining pattern. Grade 0= no staining, grade 1= trace staining, grade 2= mild staining, grade 3= moderate staining, and grade 4= severe staining.|6 months||||Scores on a scale||Standard Deviation|Mean
2621342|NCT01947283|Primary|Patient Shared Decision Making in Behavioral Health (SDM -BH)- Patient Version|The 10 items was developed by research team to evaluate patient SDM from a patient-provider visit in behavioral health. Items are rated on a 6-point Likert scale ranging from 1 (completely disagree) to 6 (completely agree). Final scores are sum of rating, which ranges between 6 and 60. A high score indicates good communication and that decision making was shared between patient and provider, as perceived by the patient.|End-of-intervention Assessment (5 months)|All participants who were enrolled in the study after the baseline interview and whose data was analyzed. SDM-BH patient version was not administered to providers. Measure was not assessed for Non-RCT patients.|||units on a scale||Standard Deviation|Mean
2621343|NCT01947283|Primary|Perceptions of Care Survey - Global Evaluation of Care Scale (PoC)|Assesses patient perceptions of care in psychiatric settings. Includes 3 items, final scores are scored externally, and range from 0 (lowest quality) to 100 (highest quality).|End-of-intervention Assessment (5 months)|All participants who were enrolled in the study after the baseline interview and whose data was analyzed. PoC was not administered to providers. Measure was not assessed for Non-RCT patients.|||units on a scale||Standard Deviation|Mean
2621344|NCT01947283|Primary|Shared Decision Making Questionnaire (SDM-Q-9 Provider Version)|Evaluates provider SDM from a patient-provider visit based on their perception of nine steps deemed essential to SDM in a clinical encounter. Rated on a 6-point Likert scale ranging from 0 (completely disagree) to 5 (completely agree). Final scores are sum of rating, which ranges between 0 and 45. Converted to 0 (lowest level) and 100 (highest level).|Follow-up Assessment (2 months)|All participants who were enrolled in the study after the baseline interview and whose data was analyzed. Each enrolled provider completed a follow-up assessment for each of their enrolled patients, following the audio recording of their clinical session.|||units on a scale||Standard Deviation|Mean
2621345|NCT01947283|Primary|Provider Shared Decision Making in Behavioral Health (SDM -BH) Provider Version|The 10 items was developed by research team to evaluate provider SDM from a patient-provider visit in behavioral health. Items are rated on a 6-point Likert scale ranging from 1 (completely disagree) to 6 (completely agree). Final scores are sum of rating, which ranges between 6 and 60. A high score indicates good communication and that decision making was shared between patient and provider, as perceived by the provider.|Follow-up Assessment (2 months)|All participants who were enrolled in the study after the baseline interview and whose data was analyzed. Each enrolled provider completed a follow-up assessment for each of their enrolled patients, following the audio recording of their clinical session.|||units on a scale||Standard Deviation|Mean
2621346|NCT01947283|Primary|Shared Decision Making Questionnaire (SDM-Q-9 Patient Version)|Evaluates patient SDM from a patient-provider visit based on their perception of nine steps deemed essential to SDM in a clinical encounter. Rated on a 6-point Likert scale ranging from 0 (completely disagree) to 5 (completely agree). Final scores are sum of rating, which ranges between 0 and 45. Converted to 0 (lowest level) and 100 (highest level).|End-of-intervention Assessment (5 months)|All participants who enrolled in the study after the baseline interview and whose data was analyzed. SDM-Q-9 patient version was not administered to providers. Measure was not assessed for Non-RCT patients.|||units on a scale||Standard Deviation|Mean
2621347|NCT01947283|Primary|Shared Decision Making (OPTION) Independent Blind Coder Assessment Scores|12 items designed to assess SDM quality in medical visit. Rated on 5 point Likert scales ranging from 0 (behavior not observed) -- 4 (clinician exhibited behavior to high standard). Final scores are the sum of the rating and range from 0-44. Final scores were transformed to a scale that ranges from 0 (lowest SDM) - 100 (highest SDM).|Follow-up assessment (2 months)|"All participants who enrolled in the study after the baseline interview and whose data was analyzed. Measure for Control Providers and Intervention Providers is the average across all of their RCT patients, irrespective of whether they were intervention or control patients. Differences from overall numbers are due to missing observations."|||units on a scale||Standard Deviation|Mean
2621348|NCT01947153|Secondary|Linagliptin: AUC 0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|"Linagliptin:~AUC 0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-L: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2621349|NCT01947153|Secondary|Metformin: AUC 0-inf (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"Metformin:~AUC 0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-M: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for metformin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of metformin|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2621350|NCT01947153|Secondary|Linagliptin: AUC 0-inf (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity)|"Linagliptin:~AUC 0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-L: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2621351|NCT01947153|Primary|Metformin: Cmax (Maximum Measured Concentration of the Analyte in Plasma)|"Metformin:~Cmax (maximum measured concentration of the analyte in plasma)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-M: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for metformin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of metformin|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2621352|NCT01947153|Primary|Linagliptin: Cmax (Maximum Measured Concentration of the Analyte in Plasma)|"Linagliptin:~Cmax (maximum measured concentration of the analyte in plasma)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS-L: includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2621353|NCT01947153|Primary|Metformin: AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|"Metformin:~AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|The subject set for the evaluation of pharmacokinetic endpoints of metformin (PKS-M): includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for metformin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of metformin|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2621354|NCT01947153|Primary|Linagliptin: AUC 0-72 (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 72 Hours)|"Linagliptin:~AUC 0-72 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 72 hours)"|2 hours (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|subject set for the evaluation of pharmacokinetic endpoints of linagliptin (PKS-L): includes all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint for linagliptin and had no important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints of linagliptin|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2621355|NCT01947127|Secondary|Hospital Length of Stay|Numbers of days spent in the hospital since the emergency department arrival to hospital discharge|Patients will be followed for the duration of hospital stay, an expected average of 7 days||||Days||Inter-Quartile Range|Median
2621356|NCT01947127|Secondary|All-cause Mortality Rates|Electronic database retrieval of in- and outpatient clinical records together with telephone follow-ups to the patients or their contact personnel are employed to every case in the next 30 days after the day of presentation to the emergency department to identify the deceased cases. All-cause mortality rates of each cohort will be compared by the survival analysis.|30 days after the day of presentation to the emergency department|Four patients out of 392 patients were excluded from secondary (mortality) outcome analysis due to unknown mortality status. As a result, 388 patients (139 in high lactate group and 249 in low lactate group) were available for mortality outcome analysis.|||participants|||Number
2621357|NCT01947127|Primary|Proportion of the Patients Who Require Vasopressor/Mechanical Ventilator|Proportion of the patients in each cohort who require vasopressor/mechanical ventilator to maintain their vital signs in the next 72 hours after venous lactate measurement.|72 hours after venous lactate measurement||||participants|||Number
2621358|NCT01946542|Secondary|Vascular Function|flow-mediated dilation (FMD)|Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)|Given that only one participant completed each arm of the study, we are unable to report outcomes as group means. To report the individual demographic, clinical, and/or physiological characteristics of these participants would present significant and unnecessary risk of loss of confidentially. Thus, no outcome data is reported.||||||
2621359|NCT01946542|Primary|Exercise Tolerance|treadmill time to exhaustion, cardiopulmonary exercise test|Testing Visit 1 (1-2 weeks from baseline) and Testing Visit 2 (2-3 weeks from baseline)|Given that only one participant completed each arm of the study, we are unable to report outcomes as group means. To report the individual demographic, clinical, and/or physiological characteristics of these participants would present significant and unnecessary risk of loss of confidentially. Thus, no outcome data is reported.||||||
2621360|NCT01946529|Secondary|Local Failure Rate|Loco-regional failure is defined as the time interval from date of start of local therapy to date of loco-regional failure. Distant failure or death prior to loco-regional failure will be considered competing events in the analyses. The cumulative incidence of loco-regional failure will be estimated using methods described in Kalbfleisch and Prentice.|Maximum of 11 years after the start of therapy|||||||
2621361|NCT01946529|Secondary|Time to Progression|Median time to progression of group B patients will be estimated from the Kaplan-Meier curve.|Maximum of 11 years after the start of therapy|||||||
2621362|NCT01946529|Secondary|Progression-free Survival|Progression free survival (PFS) is defined as the time interval from the date on study to the date of disease progression or death or the date if last follow-up. PFS will be estimated using the method of Kaplan-Meier for group A and B participants, respectively.|Maximum of 11 years after the start of therapy|||||||
2621363|NCT01946529|Secondary|Overall Survival|Overall survival (OS) is defined as the time interval from the date on study to the date of death or the date of last follow-up. OS will be estimated using the method of Kaplan-Meier for group A and B participants, respectively.|Maximum of 11 years after the start of therapy|||||||
2621364|NCT01946529|Primary|Response to Window Therapy (2 Courses) for Group B (High-risk) - ESFT Participants|Response rate will be defined as the proportion of patients who achieved complete response or partial response (CR+PR) using the World Health Organization (WHO) criteria evaluated after two initial courses of temsirolimus, temozolomide and irinotecan in previously untreated patients with high risk Ewing Sarcoma Family of Tumor (ESFT). Participants who are treated in Group B with Desmoplastic Small Round Cell Tumor (DSRCT) or those who do not receive window therapy will not be included in this analysis.|at 6 weeks after start of therapy (after 2 initial courses)|Of the 17 Group B participants with high-risk ESFT, 12 received window therapy and are considered evaluable for this outcome.|||participants|||Number
2621413|NCT01945996|Secondary|Change in Summary of Diabetes Self-care Activities - General Diet Sub Score|change in number of days patient followed a general diet plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)|3 months follow up||||units on a scale||95% Confidence Interval|Mean
2621365|NCT01946438|Secondary|Geometric Mean Titer Ratios (GMTRs) of Antibodies to Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Following Vaccination With the Respective Vaccine|Influenza virus antibodies were measured using an HAI assay. Geometric mean titer ratios are the geometric means of the individual post-vaccination/pre-vaccination titer ratios for each hemagglutinin antigen contained in the vaccines.|Day 21 after vaccination|Geometric mean titer ratios against each hemagglutinin antigen were assessed in the Per-Protocol Analysis Set.|||Titer Ratio||95% Confidence Interval|Geometric Mean
2621366|NCT01946438|Secondary|Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulations of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine|Influenza virus antibodies were measured using an HAI assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in titer after vaccination.|Day 0 (pre-vaccination) and Day 21 after vaccination|Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2621367|NCT01946438|Secondary|Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine|Influenza virus antibodies were measured using an HAI assay. Seroprotection was defined as a titer of ≥40 (1/dilution).|Day 0 (pre-vaccination) and Day 21 after vaccination|Seroprotection against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2621368|NCT01946438|Secondary|Geometric Mean Titers (GMTs) of Antibodies to the Antigens Contained in the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine Before and Following Vaccination With the Respective Vaccine|Influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 21 after vaccination|Geometric mean titers of antibodies against the hemagglutinin (HA) antigens were assessed in the Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2621369|NCT01946438|Primary|Number of Participants Reporting Solicited Injection-Site and Solicited Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Fluzone® Intradermal, or Fluzone® High-Dose Vaccine.|Solicited injection-site reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3: Pain, Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis, >100 mm; Fever, ≥102.1°F; Headache, Malaise, Myalgia, and Shivering, Significant, prevents daily activity.|Day 0 up to Day 21 post-vaccination|Solicited injection-site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.|||Participants|||Number
2621370|NCT01946425|Primary|Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|"Solicited injection-site reactions (6 months to <36 months of age): Tenderness, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite loss, and Irritability. Grade 3: Tenderness, Cries if limb is moved; Erythema and Swelling, ≥50 mm; Fever, >103.1ºF; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time; Appetite lost, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.~Solicited injection-site reactions (3 years to < 9 years of age): Pain, Erythema, and Swelling. Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm; Fever, ≥102.1ºF; Headache, Malaise, and Myalgia, Significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection-site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all participants who received at least one dose of study vaccine.|||Participants|||Number
2621371|NCT01946425|Secondary|Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|Influenza virus antibodies were measured using an HAI assay. Geometric mean titer ratios are the geometric means of the individual post-vaccination/pre-vaccination titer ratios for each hemagglutinin antigen contained in the vaccine.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titer ratios against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.|||Titer Ratio||95% Confidence Interval|Geometric Mean
2621372|NCT01946425|Secondary|Number of Participants Achieving Seroconversion Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|Influenza virus antibodies were measured using an HAI assay. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Seroconversion against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2621373|NCT01946425|Secondary|Number of Participants With Seroprotection Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|Influenza virus antibodies were measured using an HAI assay. Seroprotection was defined as a titer ≥40 (1/dilution).|Day 0 (pre-vaccination) and Day 28 after final vaccination|Seroprotection against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2621374|NCT01946425|Secondary|Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Following Vaccination With the 2013-2014 Formulation of Fluzone® Quadrivalent, Influenza Vaccine|Influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titers of antibodies against the hemagglutinin antigens were assessed in the Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2621375|NCT01946412|Secondary|Absolute Change From Baseline of Study 109 in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84|BMI = (Weight [in kg]) divided by (Stature [in meters]) ^2. Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).|Baseline (study 109), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).|||kg/m^2||Standard Deviation|Mean
2621376|NCT01946412|Secondary|Absolute Change From Baseline of Parent Study in Body Mass Index (BMI) at Week 12, 24, 36, 48, 60, 72 and 84|BMI = (Weight [in kg]) divided by (Stature [in meters]) ^2. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145).|Baseline (study 108), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).|||Kilogram per square meter (kg/m^2)||Standard Deviation|Mean
2621377|NCT01946412|Secondary|Absolute Change From Baseline of Study 109 in Stature at Week 12, 24, 36, 48, 60, 72 and 84|Stature was measured as height if children could stand unassisted and follow directions; otherwise, stature was measured as length. Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).|Baseline (study 109), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).|||cm||Standard Deviation|Mean
2621378|NCT01946412|Secondary|Absolute Change From Baseline of Parent Study in Stature at Week 12, 24, 36, 48, 60, 72 and 84|Stature was measured as height if children could stand unassisted and follow directions; otherwise, stature was measured as length. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145).|Baseline (study 108), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).|||Centimeters (cm)||Standard Deviation|Mean
2621379|NCT01946412|Secondary|Absolute Change From Baseline of Study 109 in Weight at Week 12, 24, 36, 48, 60, 72 and 84|Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).|Baseline (study 109), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).|||Kg||Standard Deviation|Mean
2621380|NCT01946412|Secondary|Absolute Change From Baseline of Parent Study in Weight at Week 12, 24, 36, 48, 60, 72 and 84|Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145)|Baseline (study 108), Week 12, 24, 36, 48, 60, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).|||kilogram (kg)||Standard Deviation|Mean
2621381|NCT01946412|Secondary|Absolute Change From Baseline of Study 109 in Sweat Chloride at Week 24, 48, 72 and 84|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of >=15 microliter was required for determination of sweat chloride. Baseline is defined as the most recent measurement prior to intake of the first dose of study drug in study 109 (NCT01946412).|Baseline (study 109), Week 24, 48, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively. As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).|||mmol/L||Standard Deviation|Mean
2621382|NCT01946412|Secondary|Absolute Change From Baseline of Parent Study in Sweat Chloride at Week 24, 48, 72 and 84|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in study 108 Part B (NCT01705145).|Baseline (study 108), Week 24, 48, 72 and 84 (study 109)|Safety set. Here “n” signifies those participants who were evaluable at the specified time points for each arm, respectively.As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).|||millimole per liter (mmol/L)||Standard Deviation|Mean
2621383|NCT01946412|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, Inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first dose of study drug through the end of study participation was considered treatment-emergent.|Day 1 up to Week 97 (for participants who completed study drug dosing); Day 1 up to 24 weeks after the last dose (up to Week 108, for participants who prematurely discontinued study drug dosing)|Safety set included all participants who received at least 1 dose of study drug in study 109 (NCT01946412). As per the planned analysis for this study, participants were to be analyzed based on their dosing groups as per parent study VX11-770-108 (NCT01705145).|||participants|||Number
2621384|NCT01946282|Secondary|FIT Completion for Groups Offered $5 vs. Outreach Alone, $10 vs. Outreach Alone, and $5 vs. $10 Incentive|Patients were randomly assigned to one of 3 groups: outreach only, outreach + $5 incentive upon FIT return, and outreach + $10 incentive upon FIT return. In year 4, use of financial incentives were discontinued and all patients with a normal result in year 3 were invited to complete a FIT using outreach only, regardless of their original intervention group.|Each year for three years|Patients were re-invited after participation in previous year and had a negative FIT result.|||Participants|||Count of Participants
2621414|NCT01945996|Secondary|Body Mass Index|height and weight measurements|3 months after enrollment|Was not able to be collected||||||
2621415|NCT01945996|Secondary|Glycemic Control|glycosylated hemoglobin A1c|3 months after enrollment||||% glycoslated hemoglobin||95% Confidence Interval|Mean
2621385|NCT01946282|Primary|FIT Completion Among Patients Offered Any Incentive vs. Outreach Alone Each Year|Primary outcome was analyzed using an intent-to-screen approach where a 2-sided P-value <0.05 was considered statistically significant. Patients were randomly assigned to one of 3 groups: outreach only, outreach + $5 incentive upon FIT return, and outreach + $10 incentive upon FIT return. For analysis, incentive groups were combined and compared to outreach alone.|Each year for three years|If FIT is positive, patients are routed to appropriate treatment. If FIT is negative, patients mailed invitations in the following year.|||Participants|||Count of Participants
2621386|NCT01946243|Primary|Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm Low Accuracy Readers)|Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.|Scan acquired 50-60 min post-injection||||Percent Accuracy||Standard Error|Mean
2621387|NCT01946243|Secondary|Change in Reliability (Siemens Syngo.PET Software)|Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretations alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics.|Scan acquired 50-60 min post-injection||||Fleiss Kappa||95% Confidence Interval|Number
2621388|NCT01946243|Secondary|Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm All Readers)|Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.|Scan acquired 50-60 min post-injection||||Percent Accuracy||Standard Error|Mean
2621389|NCT01946243|Secondary|Change in Reliability (MIMNeuro Software)|Evaluate whether VisQ interpretation significantly improved the reliability of Amyvid scan interpretation compared with qualitative scan interpretation alone. The scan interpretation reliability will be evaluated using Fleiss' Kappa statistics.|Scan acquired 50-60 min post-injection||||Fleiss Kappa||95% Confidence Interval|Number
2621390|NCT01946243|Secondary|Change in Total Accuracy (MIMNeuro Software, All Readers)|Evaluate whether the total accuracy of Amyvid VisQ interpretation was non-inferior to the qualitative scan interpretation alone. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.|Scan acquired 50-60 min post-injection||||Percent Accuracy||Standard Error|Mean
2621391|NCT01946243|Primary|Change in Total Accuracy (MIMNeuro Software, Low Accuracy Readers)|Evaluate whether the addition of quantitation as an adjunct to qualitative interpretations (VisQ) significantly improved the total accuracy of Amyvid scan interpretation in lower accuracy readers. Only the 46 scans with autopsy from A07/A16 are used for this outcome measure.|Scan acquired 50-60 min post-injection||||Percent Accuracy||Standard Error|Mean
2621392|NCT01946204|Primary|Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR)|MFS was defined as the time from randomization to the time of first evidence of BICR-confirmed bone or soft tissue distant metastasis or death due to any cause, whichever occurred first. The MFS data for participants without metastasis or death were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and computerized tomography [CT] or magnetic resonance imaging [MRI] of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.|Up to approximately 43 Months|Intent-to-Treat (ITT) population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.|||Months||95% Confidence Interval|Median
2621393|NCT01946204|Secondary|Time to Initiation of Cytotoxic Chemotherapy|Time to initiation of cytotoxic chemotherapy was defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.|Up to approximately 43 months|ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.|||Months||95% Confidence Interval|Median
2621394|NCT01946204|Secondary|Overall Survival|Overall survival was defined as the time from randomization to the date of death due to any cause.|Up to approximately 43 months|ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.|||Months||95% Confidence Interval|Median
2621395|NCT01946204|Secondary|Time to Symptomatic Progression|Time to symptomatic progression was defined as the time from randomization to documentation in the CRF of any of the following (whichever occurred earlier): a) development of a skeletal-related event (pathologic fracture, spinal cord compression, or need for surgical intervention or radiation therapy to the bone); b) pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy; or c) development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy.|Up to approximately 43 Months|ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.|||Months||95% Confidence Interval|Median
2621396|NCT01946204|Secondary|Progression-free Survival (PFS)|PFS defined as time from randomization to first documentation of BICR-confirmed radiographic progressive disease (PD) (development of distant/local/regional metastasis)/death due to any cause whichever occurred first. PFS data for participants without loco-regional disease were performed for US/ex-US regulatory purposes. Radiographic scans (bone scans and CT/MRI of chest,abdomen,pelvis) performed for detection of metastasis throughout study. PD based on RECIST v1.1; Subjects with one measurable lesion, At least 20% increase in sum of diameters of target lesions taking as reference smallest sum on study. In addition, sum must demonstrate an absolute increase of at least 5 millimeter(mm). Also, appearance of one/more new lesions was also considered PD. Subjects with non-measurable disease as per CT/MRI scans, unequivocal progression/appearance of one or more new lesions was considered PD. For new bone lesions detected on bone scans, second imaging (CT/MRI) was required to confirm PD.|Up to approximately 43 Months|ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.|||Months||95% Confidence Interval|Median
2622232|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4)||Visit 5 (Month 4)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||participants|||Number
2621397|NCT01946204|Secondary|Time to Metastasis (TTM)|Time to metastasis (TTM) was defined as the time from randomization to the time of the scan that showed first evidence of BICR-confirmed radiographically detected bone or soft tissue distant metastasis. The TTM data for participants without metastasis were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and CT or MRI of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.|Up to approximately 43 Months|ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.|||Months||95% Confidence Interval|Median
2621398|NCT01946178|Post-Hoc|Total Time Required to Deliver Treatment|The total treatment time was measured for each patient from the beginning of HIFU energy emission until HIFU energy emission stopped.|The total treatment time was measured on the day of treatment.|Total treatment times are reported for all treated patients. Total treatment times are stratified between two cohorts: an early Development Cohort and a final Validation Cohort.|||minutes||Full Range|Mean
2621399|NCT01946178|Secondary|HIFU-related Non-Perfused Volume (NPV)|Efficacy of the treatment was quantified by measuring the HIFU-related Non-Perfused Volume (NPV) of tissue in each patient using either post-treatment contrast-enhanced magnetic resonance imaging (MRI) or pathology assessment following hysterectomy. The NPV is used to measure the amount of tissue that was treated during the procedure.|The NPV was measured between 0 and 7 days post-treatment.|HIFU-related Non-Perfused Volumes (NPVs) are reported for all treated patients in whom they were observed following treatment. NPV outcomes are stratified between two cohorts: an early Development Cohort and a final Validation Cohort.|||cubic centimeters (cc)||Full Range|Mean
2621400|NCT01946178|Primary|Evaluation of All Adverse Events Encountered|Safety of the treatment was determined by evaluating the incidence of Adverse Events and Adverse Device Effects. Adverse Device Effects are Adverse Events that are related to treatment with the device. Relatedness of an Adverse Event to the treatment was determined on a case-by-case basis by the investigator. The average number of Serious Adverse Device Effects per patient and the average number of Non-Serious Adverse Device Effects per patient are reported to provide numeric outcomes of this evaluation.|Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment).|All Adverse Device Effects are reported for the entire study population (all treated patients).|||Adverse Device Effects / patient||Full Range|Mean
2621401|NCT01946165|Secondary|Proportion of Participants With Positive Surgical Margins|The difference in the rate of positive surgical margins between the two groups will be descriptively summarized.|For both groups, tumor samples collected at baseline and during surgery.||||Participants|||Count of Participants
2621402|NCT01946165|Primary|Proportion of Participants With Pathologic Stage Less Than or Equal to ypT2N0|The proportion of participants with pathologic stage less than or equal to ypT2N0 will be descriptively summarized and compared between the two treatment arms. The proportion will be calculated as the number of patients with less than or equal to ypT2N0 in each treatment arm divided by the total number of patients who underwent surgery in the same arm.|For all participants who underwent surgery, from start of treatment until surgery is completed|Patients that are evaluable are included in these values.|||Participants|||Count of Participants
2621403|NCT01946126|Secondary|Number of Visits for Headache Diagnosis|The number of visits for headache diagnosis is evaluated through the study period.|15 Months|All enrolled subjects|||Visits||Standard Deviation|Mean
2621404|NCT01946126|Secondary|Highest Number of Headache Days Per Month at a Qualifying Visit|The highest number of headache days per month are reported at a qualifying visit per the medical record.|15 Months|All enrolled subjects with data for this outcome measure|||Days||95% Confidence Interval|Mean
2621405|NCT01946126|Secondary|Number of Days With a Headache Recorded at the Visit With the Highest Number of Headaches|The number of headache days is reported at the visit with the highest number of headaches.|15 Months|All enrolled subjects|||Headache Days||95% Confidence Interval|Mean
2621406|NCT01946126|Secondary|Number of Unique Prophylactic Medications for Headache/Migraine Reported|The numbers of unique prophylactic medications used by the subjects for headache/migraine are evaluated through the study period.|15 Months|All enrolled subjects|||Medications||Standard Deviation|Mean
2621407|NCT01946126|Primary|Presence or Absence of Prophylactic Medication for Headache/Migraine|The presence or absence of prophylactic medications used by the subject for headache/migraine is evaluated through the study period.|15 Months|All enrolled subjects|||Participants|||Number
2621408|NCT01945996|Secondary|Change in Summary of Diabetes Self-care Activities - Carb Spacing Sub Score|change in number of days patient followed a carb spacing plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)|3 months follow up||||units on a scale||95% Confidence Interval|Mean
2621409|NCT01945996|Secondary|Change in Summary of Diabetes Self-care Activities - Foot Care Sub Score|change in number of days patient followed a foot care plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)|3 months follow up||||units on a scale||95% Confidence Interval|Mean
2621410|NCT01945996|Secondary|Change in Summary of Diabetes Self-care Activities - Blood Glucose Sub Score|change in number of days patient checked blood sugar (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)|3 months follow up||||units on a scale||95% Confidence Interval|Mean
2621411|NCT01945996|Secondary|Change in Summary of Diabetes Self-care Activities - Exercise Sub Score|change in number of days patient exercised (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)|3 months follow up||||units on a scale||95% Confidence Interval|Mean
2621412|NCT01945996|Secondary|Change in Summary of Diabetes Self-care Activities - Specific Diet Sub Score|change in number of days patient followed a diabetes specific diet plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)|3 months follow up||||units on a scale||95% Confidence Interval|Mean
2621416|NCT01945996|Secondary|Change in Problem Areas in Diabetes Scale|"Change in Problem areas in diabetes scale (a measure of mental health problems that patient experience related to their diabetes) Baseline minus 3 month follow up.~Higher score = more problems scale minimum 0 scale maximum 100 worst possible change -100 (0 problem scale at baseline, 100 at follow up) best possible change 100 (100 problem scale at baseline, 0 at follow up"|3 months after enrollment||||units on a scale||95% Confidence Interval|Mean
2621417|NCT01945996|Secondary|Change in Self-efficacy|Change Diabetes Empowerment Scale - Short Form( measures feelings of self efficacy regarding diabetes disease management) from baseline to 6 month follow up scale minimum 8, maximum 40 Best possible change 40 (maximum at follow up) minus 8 (minimum at follow up)=32 Worst possible change: -32|3 months after enrollment||||units on a scale||95% Confidence Interval|Mean
2621418|NCT01945996|Secondary|Diabetes Knowledge Test Scale|Diabetes Knowledge Test Scale measures specific areas of diabetes knowledge, and is geared to specific curriculum|3 months after enrollment|Data was not collected as final program educational curriculum did not have sufficient overlap with Diabetes Knowledge Test Scale||||||
2621419|NCT01945996|Primary|Acceptability 2: Would Patients Recommend the Program to Family or Friends?|Response to: Would you recommend TExT-MED FANS to family or friends?|3 months follow up||||Participants|||Count of Participants
2621420|NCT01945996|Primary|Acceptability|Patient response to: I have enjoyed the TExT-MED FANS (Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter) program?|3 months after enrollment||||Participants|||Count of Participants
2621421|NCT01945996|Primary|Feasibility|Number of patients lost to follow-up|3 months after enrollment||||Participants|||Count of Participants
2621422|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Acute, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 1||||percentage of vascular dilation||Standard Deviation|Mean
2621423|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Chronic, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to before consumption day 8|Intention to treat|||percentage of vascular dilation||Standard Deviation|Mean
2621424|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Acute-upon-chronic, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 8||||percentage of vascular dilation||Standard Deviation|Mean
2621425|NCT01945970|Other Pre-specified|Endothelium-Independent Dilation, Acute, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 1||||percentage of vascular dilation||Standard Deviation|Mean
2621426|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Chronic, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to before consumption day 8|Intention to treat|||percentage of vascular dilation||Standard Deviation|Mean
2621438|NCT01945944|Secondary|Dead Space|in % of tidal volume, using parameters on mechanical ventilator. Dead space is a measure of how much of the lung is not able to move air into and out of the body. Higher levels of dead space reflect higher levels of lung dysfunction.|during mechanical ventilation (typically 4 days - 2 weeks)||||percentage of lung volume||Inter-Quartile Range|Median
2621439|NCT01945944|Secondary|Oxygenation|SaO2/FiO2. This is a measure of how will the lungs are providing oxygen to the body. Higher ratios reflect better lung function.|during mechanical ventilation (typically 4 days - 2 weeks)||||ratio||Inter-Quartile Range|Median
2621427|NCT01945970|Other Pre-specified|Endothelium Independent Dilation, Acute-upon-chronic, Black Tea|"FMD measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 8|Intention to treat|||percentage of vascular dilation||Standard Deviation|Mean
2621428|NCT01945970|Other Pre-specified|Diastolic Blood Pressure, Positive Control|Change in Diastolic Blood pressure|From before consumption on day 1 to before consumption day 8||||mmHg||Standard Deviation|Mean
2621429|NCT01945970|Other Pre-specified|Systolic Blood Pressure, Positive Control|Change in systolic blood pressure|From before consumption (baseline) day 1 to before consumption day 8|Intention to treat|||mmHg||Standard Deviation|Mean
2621430|NCT01945970|Other Pre-specified|Diastolic Blood Pressure Black Tea|Change in Diastolic blood pressure|From before consumption on day 1 to before consumption day 8||||mmHg||Standard Deviation|Mean
2621431|NCT01945970|Other Pre-specified|Systolic Blood Pressure, Black Tea|Change in Systolic blood pressure|From before consumption on day 1 to before consumption on day 8||||mmHg||Standard Deviation|Mean
2621432|NCT01945970|Secondary|Flow Mediated Dilation, Chronic, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to before consumption day 8|Intention to treat|||percentage of flow mediated dilation||Standard Deviation|Mean
2621433|NCT01945970|Secondary|Flow Mediated Dilation, Acute, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 1|Intention to treat|||percentage of flow mediated dilation||Standard Deviation|Mean
2621434|NCT01945970|Secondary|Flow Mediated Dilation, Acute-upon-chronic, Positive Control|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 8|Intention to treat|||percentage of flow mediated dilation||Standard Deviation|Least Squares Mean
2621435|NCT01945970|Secondary|Flow Mediated Dilation, Chronic, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption day 1 to before consumption day 8.||||percentage of flow mediated dilation||Standard Deviation|Least Squares Mean
2621436|NCT01945970|Secondary|Flow Mediated Dilation, Acute, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 1|Intention to treat|||percentage of flow mediated dilation||Standard Deviation|Least Squares Mean
2621437|NCT01945970|Primary|Flow Mediated Dilation, Acute-upon-chronic, Black Tea|"Flow mediated dilation (FMD) measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (Resting stage)~5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)~4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)~When the artery had returned to baseline a second 1 minute scan was taken~25 µg sublingual glyceryl trinitrate (GTN) was given to the subject~5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation)."|From before consumption on day 1 to 2 hours post consumption on day 8.|Intention to treat|||percentage of flow mediated dilation||Standard Deviation|Least Squares Mean
2621441|NCT01945944|Secondary|Change in Serum Sodium From Baseline|The baseline sodium was the last level measured prior to study initiation, typically within 24hrs of study initiation. The change in blood sodium level was calculated as the difference between the mean post-enrollment sodium level during ICU care and the sodium level at enrollment.|during hospitalization (typically 4 days - 2 weeks)||||mEq/L||Inter-Quartile Range|Median
2621442|NCT01945944|Secondary|Hospital Length of Stay||during hospitalization (typically 4 days - 2 weeks)||||days||Inter-Quartile Range|Median
2621443|NCT01945944|Secondary|ICU Length of Stay||during hospitalization (typically 4 days - 2 weeks)||||days||Inter-Quartile Range|Median
2621444|NCT01945944|Secondary|Wheezing|as dichotomous outcome (yes/no) following drug administration|during mechanical ventilation (typically 4 days - 2 weeks)||||percentage of drug doses w/ wheezing|||Number
2621445|NCT01945944|Secondary|Atelectasis|"using chest x ray score. The score measures the amount of lung collapse (atelectasis) observed on a chest x-ray. For each of the 5 lung lobes, 1 point is given for linear atelectasis, 2 points for sub-segmental atelectasis and 3 points for lobar atelectasis. The range is 0-15 points, with higher scores reflecting more severe lung collapse."|during mechanical ventilation (typically 4 days - 2 weeks)||||units on a scale||Inter-Quartile Range|Median
2621446|NCT01945944|Primary|Duration of Mechanical Ventilation||typically 4 days - 2 weeks||||hours||Inter-Quartile Range|Median
2621447|NCT01945866|Secondary|OCT CSF Thickness Area Under the Curve Between Randomization and 24 Weeks|Including participants who completed the 24-week visit. Time points for which data were collected for this analysis include 0, 4 8,12, 16, 20, and 24 weeks post randomization.|24 weeks after randomization||||microns|Eyes|Standard Deviation|Mean
2621448|NCT01945866|Secondary|Eyes With OCT CSF Thickness < the Gender-specific Spectral Domain OCT Equivalent of 250 Microns on Zeiss Stratus|Gender and OCT machine-specific values for OCT central subfield thickness (in microns) are defined as: <290 in women and <305 in men in Zeiss Cirrus; <305 in women and <320 in men in Heidelberg Spectralis|24 weeks after randomization||||Eyes|Eyes||Number
2621449|NCT01945866|Secondary|Number of Eyes With ≥1 and ≥2 logOCT Step Gain or Loss in CSF Thickness|Change in optical coherence tomography (OCT) central subfield (CSF) thickness (in microns) was truncated to 3 standard deviations from the mean [-372, +201] (calculated using observed changes at 24 weeks combining all treatment groups), to minimize the effect of outliers. Two values were truncated in the sham + ranibizumab group: one on the negative end, and one on the positive end.|24 weeks after randomization||||Eyes|Eyes||Number
2621450|NCT01945866|Secondary|Mean Change in OCT CSF Thickness, Adjusted for Thickness at Time of Randomization|Change in optical coherence tomography (OCT) central subfield thickness (in microns) was truncated to 3 standard deviations from the mean [-372, +201] (calculated using observed changes at 24 weeks combining all treatment groups), to minimize the effect of outliers. Two values were truncated in the sham + ranibizumab group: one on the negative end, and one on the positive end.|24 weeks after randomization||||microns|Eyes|Standard Deviation|Mean
2621451|NCT01945866|Secondary|Visual Acuity Area Under the Curve (AUC) Between Randomization and 24 Weeks|Only included participants who completed the 24-week visit. Time points for which data were collected for this analysis include 0, 4 8,12, 16, 20, and 24 weeks post randomization.|24 weeks after randomization||||Letter Score|Eyes|Standard Deviation|Mean
2621452|NCT01945866|Secondary|At 24 Weeks After Randomization, Number of Eyes With at Least 10 and at Least 15 Letter Gain (Increase) or Loss (Decrease) in E-ETDRS Letter Score Visual Acuity.|ETDRS (Early Treatment Diabetic Retinopathy Study)|24 weeks weeks after randomization||||Eyes|Eyes||Number
2621453|NCT01945866|Primary|Mean Change in Visual Acuity Letter Score|At 24 weeks after randomization, mean change in visual acuity letter score, adjusted for visual acuity at time of randomization|24 weeks after randomization||||Letter Score|Eyes|Standard Deviation|Mean
2621454|NCT01945775|Other Pre-specified|Time to Deterioration (TTD) in Breast Symptoms Scale as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC-QLQ-BR23)|TTD was defined as the time (in months) from randomization to the first observation with a>=10 point increase and no subsequent observations with a <10 point increase from baseline in breast symptom score based on the EORTC-QLQ-BR23. EORTC-QLQ-BR23 is a disease-specific module for breast cancer developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer. EORTC-QLQ-BR23 symptoms subscale includes 4 items: systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss. Each item is rated by choosing 1 of 4 possible responses that record the level of intensity (1= not at all, 2= a little, 3= quite a bit, and 4= very much), higher scores=high level of symptom/problems.|Baseline up to a maximum duration of 36.9 months|PRO-evaluable population included all participants who completed the PRO questionnaire at baseline and at least 1 visit postbaseline.|||months||95% Confidence Interval|Median
2621455|NCT01945775|Other Pre-specified|Time to Deterioration (TTD) in Global Health Status/Quality of Life (QOL)|TTD in global health status (GHS)/QoL=time (in months) from randomization to the first observation with >=10 point decrease and no subsequent observations with<10 point decrease from baseline in GHS/QoL score based on EORTC-QLQ-C30. EORTC QLQ-C30 is a cancer-specific instrument with 30 questions to assess participant quality of life. Question 29 and 30 were used to evaluate GHS/QoL. Each question was assessed on a 7-point scale (1=very poor to 7=excellent). Scores averaged, transformed to 0-100 scale; higher score=better quality of life/better level of functioning.|Baseline up to a maximum duration of 36.9 months|PRO-evaluable population included all participants who completed the PRO questionnaire at baseline and at least 1 visit postbaseline.|||months||95% Confidence Interval|Median
2621469|NCT01945710|Secondary|Percentage of Participants With Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants with BOR of CR or PR or durable stable disease (dSD) [CR + PR + dSD] based on RECIST v1.1. The dSD rate was defined as the percentage of participants with dSD (based on RECIST 1.1 and defined as SD lasting greater than or equal to 6 months), as determined by the site Investigator.|From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date (17 May 2016), for up to approximately 3 years 7 months|The SAS was the group of participants who received study drug and had at least 1 post-dose safety assessment.|||percentage of participants||95% Confidence Interval|Median
2621456|NCT01945775|Other Pre-specified|Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) for Overall Duration (Averaged of Week 4 to 160)|EORTC QLQ-C30: cancer-specific instrument with 30 questions to assess the participant QoL. First 28 questions used to evaluate 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, nausea and vomiting, pain) and other single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Each question assessed on 4-point scale (1= not at all, 2= a little, 3= quite a bit, 4= very much); functional scales: higher score = better level of functioning; symptom scale: higher score = more severe symptoms; for single items: higher score= more severe problem. Last 2 questions used to evaluate global health status (GHS)/QoL. Each question was assessed on 7-point scale (1= very poor to 7= excellent). Scores averaged, transformed to 0-100 scale; higher score=better quality of life/better level of functioning. Change from baseline was calculated by subtracting the baseline value from the average value of Week 4 to 160.|Baseline, Week 4 up to Week 160 (Overall Duration)|Patient-reported outcomes (PRO) evaluable population included all participants who completed the PRO questionnaire at baseline and at least 1 visit post baseline.|||units on scale||95% Confidence Interval|Mean
2621457|NCT01945775|Other Pre-specified|Duration of Response (DOR): Investigator Assessment|DOR = time from first radiographic documentation of OR (PR or CR) till radiographic disease progression (PD) as per RECIST v1.1 by investigator assessment or to death due to any cause, whichever was first. RECIST 1.1, a) target lesion (TL): CR= disappearance of all non-nodal TL, target lymph nodes reduce to <10 mm in short axis, PR= at least 30% decrease in sum of diameters of TL, compared to the sum at baseline, PD= at least 20% increase in sum of TL measurements, compared to smallest sum on study including baseline, absolute increase in sum has to be at least 5 mm; b) for non-TL: CR= disappearance of all non-TL, PD= unequivocal progression of non-TL, such that treatment has failed, disease is progressing, regardless of status of TL; c) PD =and/or appearance of >=1 new lesions. DOR = (earliest date of progression, death, or censoring-date of first documented OR + 1)/30.4375. Analysis was performed by Kaplan-Meier method.|From first documentation of CR or PR until disease progression or death due to any cause, whichever occurred first (up to 36.9 months)|ITT with measurable disease analysis population included all participants in the ITT population who had at least 1 target lesion identified at baseline.|||months||Inter-Quartile Range|Median
2621458|NCT01945775|Secondary|Number of Participants Taking At-least One Concomitant Medication|Any medication (other than study drug) which was administered to participants during study after first dose of study drug were considered as concomitant medications.|Baseline up to primary analysis study cut-off date (up to a maximum duration of 36.9 months)|Safety analysis population included all participants who received at least 1 dose of any study drug (talazoparib or protocol-specified PCT).|||Participants|||Count of Participants
2621459|NCT01945775|Secondary|Number of Participants With Potentially Clinically Significant Changes From Baseline in Vital Signs|Criteria for potentially clinically significant changes in vital signs included a) Systolic blood pressure: 1) absolute results (AB) greater than (>) 180 millimeter of mercury (mmHg) and increase from baseline (IFB) greater than or equal to (>=) 40 mmHg, 2) absolute results less than (<) 90 mmHg and decrease from baseline (DFB) >30 mmHg; b) Diastolic blood pressure: 1) absolute results >110 mmHg and >=30 mmHg increase from baseline, 2) absolute results <50 mmHg and >20 mmHg decrease from baseline 3) >=20 mmHg increase from baseline; c) Heart rate: 1) absolute results>120 beats per minute [bpm] and >30 bpm increase from baseline, 2) absolute results <50 bpm and >20 bpm decrease from baseline and d) Weight: >10 percent [%] decrease from baseline.|Baseline up to primary analysis study cut-off date (up to a maximum duration of 36.9 months)|Safety analysis population included all participants who received at least 1 dose of any study drug (talazoparib or protocol-specified PCT).|||Participants|||Count of Participants
2621460|NCT01945775|Secondary|Number of Participants With Grade 3 or 4 Postbaseline Toxicities in Laboratory Parameters: Chemistry|Toxicity grades were evaluated based on as NCI CTCAE v4.03. NCI CTCAE v4.03 defined the severity grade as: grade 1 (mild), grade 2 (moderate), grade 3 (severe) and grade 4 (potentially life threatening) and grade 5 (death related to AE) for each parameter. Key chemistry parameters included alanine aminotransferase (units per liter), alkaline phosphatase (units per liter), aspartate aminotransferase (units per liter) and bilirubin (micromole per liter). High value indicated higher values than the baseline values and low value indicated lower values than the baseline values. Only those categories in which at least 1 participant had data were reported.|Baseline up to primary analysis study cut-off date (up to a maximum duration of 36.9 months)|Safety analysis population included all participants who received at least 1 dose of any study drug (talazoparib or protocol-specified PCT).|||Participants|||Count of Participants
2621461|NCT01945775|Secondary|Number of Participants With Grade 3 or 4 Postbaseline Toxicities in Laboratory Parameters: Hematology|Toxicity grades were evaluated based on as National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03). NCI CTCAE v4.03 defined the severity grade as: grade 1 (mild), grade 2 (moderate), grade 3 (severe) and grade 4 (potentially life threatening) and grade 5 (death related to AE) for each parameter. Key hematology parameters included hemoglobin (gram per liter [g/L]), leukocytes (10^6 cells per liter), lymphocytes (10^6 cells per liter), neutrophils (10^6 cells per liter), and platelets (10^9 cells per liter). Low value indicated lower values than the baseline values and high value indicated higher values than the baseline values. Only those categories in which at least 1 participant had data were reported.|Baseline up to primary analysis study cut-off date (up to a maximum duration of 36.9 months)|Safety analysis population included all participants who received at least 1 dose of any study drug (talazoparib or protocol-specified PCT).|||Participants|||Count of Participants
2621470|NCT01945710|Secondary|Percentage of Participants With Disease Control Rate (DCR)|DCR was the percentage of the participants who had BOR of CR, PR, and SD, based on assessments by each site investigator using RECIST v1.1. The minimum duration of SD was defined as 5 weeks (or 7 weeks for Schedules 1a and 2 in the Dose Escalation Part) following the date of the first dose of study drug in order for stable disease to be considered the best overall response. The 95% CI was constructed using the method of Clopper and Pearson. DCR = CR + PR + SD|From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date (17 May 2016), for up to approximately 3 years 7 months|The SAS was the group of participants who received study drug and had at least 1 post-dose safety assessment.|||percentage of participants||95% Confidence Interval|Median
2621462|NCT01945775|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence (e.g., sign, symptom, illness, disease or injury) in a participant administered study drug or other protocol-imposed intervention, regardless of attribution. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to primary analysis data cut-off date or the day before initiation of a new antineoplastic therapy or 30 days after the date of the last dose date of study drug, whichever occurred first, that were absent before treatment or that worsened relative to pretreatment (up to 36.9 months) state. AEs included both SAEs and non-SAEs.|Baseline up to a maximum duration of 36.9 months|Safety analysis population included all participants who received at least 1 dose of any study drug (talazoparib or protocol-specified PCT).|||Participants|||Count of Participants
2621463|NCT01945775|Secondary|Trough Plasma Talazoparib Concentrations|A predose PK sample was considered dose-compliant based on the following criteria: A participant must have received 21 consecutive days of 1 mg talazoparib without dosing interruption prior to sample collection; and the predose PK sample must have been collected 24 hours +/- 10 percent (2 hours and 24 minutes) after the previous day's dose and no more than 5 minutes (0.083 hours) after the administration of the dose on the day of PK sample collection.|Predose on Day 1 of Cycle 2, 3 and 4|"Analysis population included participants who received at least 1 dose of talazoparib and had dose compliant pharmacokinetic (PK) predose sample. Here, “number analyzed signifies number of participants who were evaluable for the specified categories. This endpoint was not planned to be analyzed for the reporting arm “Physician’s Choice Treatment”."|||Picogram per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2621464|NCT01945775|Secondary|Overall Survival (OS)|OS was defined as the time (in months) from randomization to death due to any cause. If death was not observed at the time of study cut-off date or permanently lost to follow-up, OS was censored at the date the participant was last known to be alive on or before the study cut-off date, whichever was earlier. The analysis was performed by Kaplan-Meier method.|Baseline until death due to any cause or study cut-off (up to a maximum duration of 36.9 months)|ITT analysis population included all randomized participants.|||months||95% Confidence Interval|Median
2621465|NCT01945775|Secondary|Percentage of Participants With Objective Response: Investigator Assessment|Investigator assessed objective response was defined as the percentage of participants with a partial response (PR) or complete response (CR) as defined by RECIST v1.1. For target lesions: 1) CR: disappearance of all non-nodal target lesions. Target lymph nodes must reduce to less than 10 mm in short axis. 2) PR: At least a 30% decrease in the sum of diameters of target lesions, compared to the sum at baseline. For non-target lesions, CR: disappearance of all non-target lesions. Percentage of participants with objective response reported are based upon unconfirmed CR/PR.|Baseline until radiologic progressive disease or death due to any cause (up to a maximum duration of 36.9 months)|ITT with measurable disease analysis population included all participants in the ITT population who had at least 1 target lesion identified at baseline.|||percentage of participants||95% Confidence Interval|Number
2621466|NCT01945775|Primary|Progression-Free Survival (PFS): Independent Radiological Facility (IRF) Assessment|IRF assessed PFS was defined as time (in months) from randomization until the date of first documented radiologic progressive disease per response evaluation criteria in solid tumors (RECIST) version 1.1 or death from any cause, whichever occurs first. As per RECIST v1.1, progression defined as 1) for target lesions: at least a 20% increase in the sum of target lesion measurements, compared to the smallest sum on study (including baseline), the absolute increase in the sum has to be at least 5 millimeter (mm); 2) for non-target lesions: unequivocal progression of non-target lesions, evaluated as a whole, such that it is clear that treatment has failed and disease is progressing, regardless of the status of the target lesions; 3) and/or appearance of one or more new lesions. The analysis was performed by Kaplan-Meier method.|Baseline until radiologic progressive disease or death due to any cause (up to maximum duration of 36.9 months)|Intent-to-treat (ITT) analysis population included all randomized participants.|||months||95% Confidence Interval|Median
2621467|NCT01945710|Secondary|Number of Participants With the Indicated Shift From Baseline Category to the Indicated Worst Post-Baseline Category|The effects of eribulin-LF on cardiovascular repolarization were evaluated via 24-hour, 12-lead continuous Holter electrocardiogram (ECG) monitoring in Cycle 1, Day 1 for Schedule 1 and Day 1 and Day 15 of Schedule 2. Individual ECGs were extracted in triplicate from the Holter recordings at specified time points and were evaluated by a central laboratory. QT intervals were measured from Lead II and were corrected for heart rate (QTc) using Fridericia's (QTcF) and Bazett's (QTcB) correction factors. The primary QTc parameter was QTcF. Secondary parameters (QTcB, QT, QRS, and hazard ratio/heart rate (HR)) and waveforms (T-waves) were evaluated. BL= Baseline, PBL = post-Baseline, A,NCS = abnormal, not clinically significant, A, CS = abnormal, clinically significant|Baseline (Day -1), Schedule 1 (Cycle 1 Day 1); Schedule 2 (Cycle 1 Day 1 and Day 15)|The SAS was the group of participants who received study drug and had at least 1 post-dose safety assessment. Only participants with baseline and post-baseline values were reported.|||Participants|||Count of Participants
2621468|NCT01945710|Secondary|Percentage of Participants With Progression Free Survival (PFS)|PFS was defined as the time from the date of treatment start until progressive disease or death from any cause in the absence of progressive disease. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions as assessed by IRR using RECIST v1.1. The duration of PFS was calculated as end date minus date of first drug plus 1, based on assessments by the site Investigator. PFS was calculated using Kaplan-Meier estimate and presented with 2-sided 95% Cl.|From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date (17 May 2016), for up to approximately 3 years 7 months|PFS data was not collected as this is a Phase I dose escalation design and was not the focus of the study.||||||
2621490|NCT01945593|Secondary|Number of Participants With Binding Antibodies|Binding antibodies (IgG and IgM) against FVIII, polyethylene glycol (PEG) and PEGylated FVIII (PEG-FVIII) were analyzed using enzyme-linked immunosorbent assay (ELISA).|Baseline through end of study (53 months)|SAS included all participants with at least 1 BAX 855 infusion.|||Participants|||Count of Participants
2621471|NCT01945710|Secondary|Percentage of Participants With Objective Response Rate (ORR)|ORR was defined as the percentage of participants with BOR of CR or PR based on RECIST v1.1 criteria or target lesions assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans, as determined by independent radiologic review. BOR of CR was confirmed by a subsequent CR assessment at least 4 weeks later. BOR of PR was confirmed by a subsequent CR or PR assessment at least 4 weeks later. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. The null hypothesis ORR was less than or equal to 10% was tested using 1-sided exact test of a single proportion, at 1-sided 0.05 level. ORR was presented with corresponding 2-sided, 95% confidence interval (CI). ORR=CR+PR.|From date of treatment start until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff date (17 May 2016), for up to approximately 3 years 7 months|The SAS was the group of participants who received study drug and had at least 1 post-dose safety assessment.|||percentage of participants||95% Confidence Interval|Median
2621472|NCT01945710|Secondary|Percentage of Participants With Best Overall Response (BOR)|BOR to treatment was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. BOR was the best confirmed response of complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD), or not evaluable (NE), recorded from the start of eribulin-LF until disease progression/recurrence or death. CR; disappearance of all target lesions for at least 1 month. PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD; at least 20% or greater increase in the sum of the longest diameter of measured lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of one or more new lesions. SD; PR failed to be achieved in the overall response assessment and there was no PD observed at the end of 6 cycles or later after starting eribulin-LF.|Baseline to first date of documented CR, PR, SD, or PD, assessed up to data cutoff date (17 May 2016), for up to approximately 3 years 7 months|The SAS was the group of participants who received study drug and had at least 1 post-dose safety assessment.|||percentage of participants|||Number
2621473|NCT01945710|Secondary|Fraction of Unchanged Eribulin-LF Excreted in the Urine (fe)|Urinalysis was performed at Screening, Baseline, Cycle 1/Day 15, and each study visit of every cycle thereafter. If urinalysis suggested a urinary tract infection, or if clinically indicated, a urine microscopy, culture, and sensitivity was to be performed at the institution's laboratory. If urine protein was ≥ 2+ on urinalysis, then a 24-hour urine collection was to be done to quantify the 24-hour urine protein excretion. The samples were analyzed for the amount of eribulin in the urine using liquid LC/MS method of analysis. Urine PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of fe, which was then summarized as the mean and standard deviation for all participants and expressed in percentage of eribulin-LF.|Schedule 1: Cycle 1/Day 1 and Cycle 3/Day 1; Schedule 2: Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15|The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter.|||percent of eribulin-LF||Standard Deviation|Mean
2621474|NCT01945710|Secondary|Renal Clearance (CLr) of Eribulin-LF|Blood samples for Schedule 1 were drawn on Cycle 1/Day 1 and Cycle 3/Day 1 predose, 15 min after SOI, 5 min after EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9, and Day 11. Blood samples for Schedule 2 were drawn on Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15 predose, 15 min after SOI, 5 min after EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9 and Day 11. Some participants followed a different PK assessment schedule prior to protocol amendment 3. Plasma concentrations of eribulin-LF were determined using a validated LC/MS/MS method. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of CLr, which was then summarized as the mean and standard deviation for all participants and expressed in liters/hour (L/hr).|Schedule 1: Cycle 1/Day 1 and Cycle 3/Day 1; Schedule 2: Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15|The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter.|||mL/h||Standard Deviation|Mean
2621475|NCT01945710|Secondary|Volume of Distribution (Vd) of Eribulin-LF|Blood samples for Schedule 1 were drawn on Cycle 1/Day 1 and Cycle 3/Day 1 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9, and Day 11. Blood samples for Schedule 2 were drawn on Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9 and Day 11. Some participants followed a different PK assessment schedule prior to protocol amendment 3. Plasma concentrations of eribulin-LF were determined using a validated LC/MS/MS method. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Vd, which was then summarized as the mean and standard deviation for all participants and expressed as milliliters (mL).|Schedule 1: Cycle 1/Day 1 and Cycle 3/Day 1; Schedule 2: Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15|The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter.|||mL||Standard Deviation|Mean
2621476|NCT01945710|Secondary|Total Body Clearance (CL) of Eribulin-LF|Blood samples for Schedule 1 were drawn on Cycle 1/Day 1 and Cycle 3/Day 1 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9, and Day 11. Blood samples for Schedule 2 were drawn on Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9 and Day 11. Some participants followed a different PK assessment schedule prior to protocol amendment 3. Plasma concentrations of eribulin-LF were determined using a validated LC/MS/MS method. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of CL, which was then summarized as the mean and standard deviation for all participants and expressed as milliliter/hour (mL/h).|Schedule 1: Cycle 1/Day 1 and Cycle 3/Day 1; Schedule 2: Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15|The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter.|||mL/h||Standard Deviation|Mean
2621650|NCT01944293|Primary|Change in Suicidal Ideation Measured With the Beck Scale for Suicidal Ideation|Change in suicidal ideation in Bipolar Disorder during a Major Depressive Episode (MDE), with moderate to severe suicidal thoughts, from the pre-infusion baseline to 24 hours after the infusion of Ketamine (study drug) or Midazolam (active control).|At 24 hours post-Infusion|Bipolar depression with suicidal ideation.|||units on a scale||Standard Deviation|Mean
2621477|NCT01945710|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf)) of Eribulin-LF|Blood samples for Schedule 1 were drawn on Cycle 1/Day 1 and Cycle 3/Day 1 predose, 15 min after SOI, 5 min after EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9, and Day 11. Blood samples for Schedule 2 were drawn on Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9 and Day 11. Plasma concentrations of eribulin-LF were determined using a validated LC/MS/MS method. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of AUC(0-inf), which was then summarized as the mean and standard deviation for all participants and expressed in ng*hr/mL.|Schedule 1: Cycle 1/Day 1 and Cycle 3/Day 1; Schedule 2: Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15|The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter.|||ng*h/mL||Standard Deviation|Mean
2621478|NCT01945710|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 Time of Last Quantifiable Concentration (AUC(0-t) ) of Eribulin-LF|Blood samples for Schedule 1 were drawn on Cycle 1/Day 1 and Cycle 3/Day 1 predose, 15 min after SOI, 5 min after EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9, and Day 11. Blood samples for Schedule 2 were drawn on Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9 and Day 11. Plasma concentrations of eribulin-LF were determined using a validated LC/MS/MS method. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of AUC(0-t), which was then summarized as the mean and standard deviation for all participants and expressed in nanograms*hour/milliliter (ng*hr/mL).|Schedule 1: Cycle 1/Day 1 and Cycle 3/Day 1; Schedule 2: Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15|The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter.|||ng*h/mL||Standard Deviation|Mean
2621479|NCT01945710|Secondary|Plasma Half-life (t1/2) of Eribulin-LF|Blood samples for Schedule 1 were drawn on Cycle 1/Day 1 and Cycle 3/Day 1 predose, 15 min after SOI, 5 min after EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9, and Day 11. Blood samples for Schedule 2 were drawn on Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9 and Day 11. Plasma concentrations of eribulin-LF were determined using a validated LC/MS/MS method. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of t1/2, which was then summarized as the mean and standard deviation for all participants and expressed in hours.|Schedule 1: Cycle 1/Day 1 and Cycle 3/Day 1; Schedule 2: Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15|The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter.|||hours||Standard Deviation|Mean
2621480|NCT01945710|Secondary|Time to Maximum Plasma Concentration (Tmax) of Eribulin-LF|Blood samples for Schedule 1 were drawn on Cycle 1/Day 1 and Cycle 3/Day 1 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9, and Day 11. Blood samples for Schedule 2 were drawn on Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9 and Day 11. Some participants followed a different PK assessment schedule prior to protocol amendment 3. Plasma concentrations of eribulin-LF were determined using a validated LC/MS/MS method. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Tmax, which was then summarized as the median and full range for all participants and expressed as hours.|Schedule 1: Cycle 1/Day 1 and Cycle 3/Day 1; Schedule 2: Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15|The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter.|||hours||Full Range|Median
2621481|NCT01945710|Secondary|Maximum Plasma Concentration (Cmax) of Eribulin-LF|Blood samples for Schedule 1 were drawn on Cycle 1/Day 1 and Cycle 3/Day 1 predose, 15 minutes (min) after the start of infusion (SOI), 5 min after the end of infusion (EOI), 0.5, 1, 2, 4, 6, 8, and 24 hours (h) postdose, and Day 4, Day 7, Day 9, and Day 11. Blood samples for Schedule 2 were drawn on Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15 predose, 15 min after the SOI, 5 min after the EOI, 0.5, 1, 2, 4, 6, 8, and 24 h postdose, and Day 4, Day 7, Day 9 and Day 11. Some participants followed a different pharmacokinetic (PK) assessment schedule prior to protocol amendment 3. Plasma concentrations of eribulin-LF were determined using a validated liquid chromatography-tandem mass spectrometry (LC/MS/MS) method. Plasma PK data were analyzed using a noncompartmental analysis approach to obtain individual participant estimates of Cmax, which was then summarized as the mean and standard deviation for all participants and expressed as nanograms/milliliter (ng/mL).|Schedule 1: Cycle 1/Day 1 and Cycle 3/Day 1; Schedule 2: Cycle 1/Day 1 and Day 15 and Cycle 3/Day 1 and Day 15|The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter.|||ng/mL||Standard Deviation|Mean
2621482|NCT01945710|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of Eribulin-LF|Safety was assessed by the monitoring and recording of all adverse events (AEs), and serious AEs (SAEs), regular monitoring of hematology, clinical chemistry, and urine values; periodic measurement of vital signs, electrocardiograms; and the performance of physical examinations. For each row category, a participant with two or more adverse events in that category is counted only once. Treatment-related TEAEs include TEAEs that were considered by the Investigator to be possibly or probably related to study drug and TEAEs with a missing relationship to study drug.|From date of first dose until 30 days after the final dose of study drug, up to approximately 3 years 6 months|The SAS was the group of participants who received study drug and had at least 1 post-dose safety assessment.|||Participants|||Count of Participants
2621491|NCT01945593|Secondary|Number of Participants With Shifts in Lipid Panel Assessments|"The number of participants with clinically significant shifts from normal abnormal clinically significant (CS) and abnormal not clinically significant (abnormal NCS) at baseline to normal abnormal clinically significant (CS) and abnormal clinically significant (NCS) at completion were reported.. In the below table, HDL refers to high density lipoprotein, LDL refers to low density lipoprotein, VLDL refers to very low density lipoprotein."|Baseline through end of study (53 months)|SAS included all participants with at least 1 BAX 855 infusion.Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Participants|||Count of Participants
2621483|NCT01945710|Primary|Dose Limiting Toxicities at the Indicated Dose Levels, as an Assessment of Dosing Frequency|DLTs were evaluated for both Schedule 1 and Schedule 2. DLTs were defined as neutropenia grade 4 that lasted more than 5 days, neutropenia grade 3 or 4 complicated by fever and/or infection (absolute neutrophil count (ANC) less than 1.0 x 10^9/liter, fever greater than or equal to 38.5 degrees Celsius), thrombocytopenia grade 4 of any duration, thrombocytopenia grade 3 complicated by bleeding and/or requiring platelet or blood transfusion, hypersensitivity reaction grade 3 or 4 including allergy reactions or anaphylaxis; symptomatic bronchospasm requiring parenteral medication(s) with our without urticarial; allergy-related edema/angioedema, or other grade 3 or 4 clinically significant non-hematologic toxicities (except for inadequately treated nausea and /or vomiting) considered related to study drug. Participants with two or more adverse events in the same system organ class (or with the same preferred term) was counted only once for that system organ class (or preferred term).|Cycle 1 of Dose Escalation part in Schedule 1 and Schedule 2|Dose-finding analysis set included all participants in the dose escalation part who completed Cycle 1 treatment and were evaluated for DLTs and those who discontinued during Cycle 1 due to DLTs.|||Participants|||Count of Participants
2621484|NCT01945710|Primary|Maximum Tolerated Dose (MTD) of Eribulin-LF|The MTD was defined as the highest dose level at which no more than 1/6 participants experienced a dose limiting toxicity (DLTs), with the next higher dose having at least 2 of 3 or 2 of 6 participants experiencing DLTs. MTD was determined by summarizing the number and percentage of participants with DLTs for the first cycle, by study dosing schedule, initial dosing level and overall for the dose escalation part. For participants who continued to Cycle 2, the DLTs which occurred from 1st dose up to the day before Day 1 of Cycle 2 were counted. For participants who discontinued before Cycle 2, the DLTs which occurred from 1st dose up to Day 21 (Schedule 1) or Day 28 (Schedule 2) of Cycle 1 were counted. DLTs were evaluated and graded based on the National Cancer Institutes (NCI)'s Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.|Schedule 1: Cycle 1 (21 days); Schedule 2: Cycle 1 (28 days)|Dose finding analysis set is all participants in the dose escalation part who completed Cycle 1 treatment and were evaluated for DLTs, and those who discontinued during Cycle 1 due to DLT.|||mg/m^2|||Number
2621485|NCT01945593|Secondary|Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Pediatrics Quality of Life (PedsQL) Questionnaire|HRQoL in participants aged <14 years was measured using the PedsQL. It capture data for the following domains: physical functioning, emotional functioning, social functioning, school functioning, psychosocial functioning, physical health and a total score. Each question of the PedsQL was scored as Never: 100, almost never: 75, sometimes: 50, often: 25, almost always: 0. The mean of the individual question scores was calculated. Lower scores on the PedsQL indicating worse HRQoL. Here, FDR refers to fixed dose regimen, PK-t R refers to PK-tailored regimen. Here 'n' refers to the number of participants evaluable for this endpoint. Here 'n' refers to the number of participants evaluable for this endpoint.|Baseline, end of study (53 months)|FAS with population of age less than 14 years were analyzed.|||Score on a scale||Standard Deviation|Mean
2621486|NCT01945593|Secondary|Change From Baseline in Patient Reported Outcomes: Health-related Quality of Life (HRQoL): Short Form-36 (SF-36)|"HRQoL in participants aged >=14 years was measured using the SF-36 questionnaire. The questionnaire was divided into 8 domains and scored as:~physical functioning (1=yes, limited a lot to 3=no, not limited at all), role-physical (1=all of the time to 5=none of the time), bodily pain (1=very severe to 6=none), general health (1=poor to 5=excellent), vitality (1=none of the time to 5=all of the time), social functioning (1=all of the time: to 5=none of the time), role emotional (1=all of the time to 5=none of the time) and mental health (1=all of the time to 5=none of the time). The score for each domain is then to be transformed to a 0-100 range as [(actual raw score-lowest possible raw score)/possible raw score range]*100. Positive change scores indicate improved HRQoL. in the below table 'FDR' indicates fixed dose regimen, 'PK-tr' indicates pharmacokinetically tailored regimen and 'n' refers to the number of participants evaluable for this endpoint."|Baseline, end of study (53 months)|FAS with population of age greater than or equal to 14 years were analyzed.|||Score on a scale||Standard Deviation|Mean
2621487|NCT01945593|Secondary|Change From Baseline in Pain Severity|Hemophilia symptom (haemo-SYM) questionnaire has two subscales: pain and bleed. It was used to asses the pain severity for participants >=18 years of age as: pain because of swelling in my joints, climbing stairs, upon waking in the morning, active arthritis; constant pain, in my muscles, that needs medication; joint sensitivity to weather conditions; reduced range of joint movement, joint deformity, sleep disturbance because of pain or bleeds, blood in my urine, nose bleeds and assigned a score of 0=Absent, 1=very mild, 2=mild, 3=moderate, 4=severe and 5=very severe. The score was determined as (mean score/5)*100 where mean score is the mean of the available results in the particular subscale. Higher scores on the Haemo-SYM indicate more severe symptoms. Therefore, negative change scores indicate that symptoms have improved. Here 'n' refers to the number of participants evaluable for this endpoint.|Baseline, end of study (53 months)|FAS with population of age greater than or equal to 18 years were analyzed.|||Score on a scale||Standard Deviation|Mean
2621488|NCT01945593|Secondary|Change From Baseline in Bleed Severity|Hemophilia symptom (haemo-SYM) questionnaire has two subscales: pain and bleed. It was used to asses the bleed severity for participants >=18 years of age as: severity of spontaneous bleeding in my joints (unrelated to injury or activity), spontaneous bleeding in my muscles (unrelated to injury or activity), prolonged bleeding after injury in spite of treatment, intense pain because of bleeding event, joint pain due to active bleed and bleeding during personal hygiene routine, blood in my urine, nose bleeds and assigned a score of 0=Absent, 1=very mild, 2=mild, 3=moderate, 4=severe and 5=very severe. The score was determined as (mean score/5)*100 where mean score is the mean of the available results in the particular subscale. Higher scores on the Haemo-SYM indicate more severe symptoms. Therefore, negative change scores indicate that symptoms have improved. Here 'n' refers to the number of participants evaluable for this endpoint.|Baseline, end of study (53 months)|FAS with population of age greater than or equal to 18 years were analyzed.|||Score on a scale||Standard Deviation|Mean
2621489|NCT01945593|Secondary|Number of Participants With Anti-Chinese Hamster Ovary (CHO) Antibodies|Testing for binding of anti-CHO protein antibodies was performed on citrate-anti-coagulated plasma using an ELISA employing polyclonal antihuman IgG antibodies.|Baseline through end of study (53 months)|SAS included all participants with at least 1 BAX 855 infusion.|||Participants|||Count of Participants
2621492|NCT01945593|Secondary|Number of Participants With Shifts in Hematology Laboratory Assessments|"The number of participants with clinically significant shifts from normal abnormal clinically significant (CS) and abnormal not clinically significant (abnormal NCS) at baseline to normal abnormal clinically significant (CS) and abnormal clinically significant (NCS) at completion were reported. In the below table, FDR refers to fixed dose regimen, PK-tR refers to PK tailored regimen at the time of sampling, Leu refers to leukocytes, MCV refers to mean corpuscular volume, Lym/Leu refers to lymphocytes/leukocytes."|Baseline through end of study (53 months)|SAS included all participants with at least 1 BAX 855 infusion. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Participants|||Count of Participants
2621493|NCT01945593|Secondary|Number of Participants With Shifts in Clinical Chemistry Laboratory Assessments.|"The number of participants with clinically significant shifts from normal abnormal clinically significant (CS) and abnormal not clinically significant (abnormal NCS) at baseline to normal abnormal clinically significant (CS) and abnormal clinically significant (NCS) at completion were reported. In the below table, FDR refers to fixed dose regimen at the time of sampling, AlA refers to alanine aminotransferase, AP refers to alkaline phosphatase, AsA refers to aspartate aminotransferase."|Baseline through end of study (53 months)|SAS included all participants with at least 1 BAX 855 infusion. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Participants|||Count of Participants
2621494|NCT01945593|Secondary|Change From Baseline in Blood Pressure|Change in systolic and diastolic blood pressure at pre-infusion and post-infusion at end of the study were reported. In the below table, FDR refers to fixed dose regimen, PK-tR refers to PK tailored regimen at the time of sampling, SBP refers to systolic blood pressure, DBP refers to diastolic blood pressure.|Baseline, end of study (53 months)|SAS with evaluable participants for this endpoint were analyzed. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2621495|NCT01945593|Secondary|Change From Baseline in Respiratory Rate|Change in respiratory rate at pre-infusion and post-infusion at end of the study was reported. In the below table, FDR refers to fixed dose regimen, PK-tR refers to PK tailored regimen at the time of sampling.|Baseline, end of study (53 months)|SAS included all participants with at least 1 BAX 855 infusion. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Breaths per minute (breaths/min)||Standard Deviation|Mean
2621496|NCT01945593|Secondary|Change From Baseline in Pulse Rate|Change in pulse rate at pre-infusion and post-infusion at end of the study was reported. In the below table, FDR refers to fixed dose regimen, PK-tR refers to PK tailored regimen at the time of sampling.|Baseline, end of study (53 months)|SAS included all participants with at least 1 BAX 855 infusion. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Beats per minute (beats/min)||Standard Deviation|Mean
2621497|NCT01945593|Secondary|Change From Baseline in Body Temperature|Change in body temperature at pre-infusion and post-infusion at end of the study was reported. In the below table, FDR refers to fixed dose regimen, PK-tR refers to PK tailored regimen at the time of sampling.|Baseline, end of study (53 months)|SAS included all participants with at least 1 BAX 855 infusion. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.|||Degree celsius||Standard Deviation|Mean
2621498|NCT01945593|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom (eg, rash, pain, discomfort, fever, dizziness, etc.), disease (eg, peritonitis, bacteremia, etc.), or outcome of death temporally associated with the use of an investigational product (IP), whether or not considered causally related to the IP. A serious adverse event (SAE) was defined as an untoward medical occurrence that at any dose met one or more of the following criteria: outcome was fatal/resulted in death; was life-threatening; required inpatient hospitalization or resulted in prolongation of an existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was a medically important event.|Baseline through end of study (53 months)|SAS included all participants with at least 1 BAX 855 infusion.|||Participants|||Count of Participants
2621499|NCT01945593|Secondary|Average Dose of BAX 855 Per Prophylactic Infusion|The average dose of BAX 855 per prophylactic infusion was reported.|Baseline through end of study (53 months)|SAS included all participants with at least 1 BAX 855 infusion.|||International units per kilogram (IU/kg)||Standard Deviation|Mean
2621500|NCT01945593|Secondary|Total Time Intervals Between Bleeding Episodes|The time interval between bleeding episodes was calculated based upon the date and time reported for each bleeding episode. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII.|Baseline through end of study (53 months)|FAS included all participants with at least 1 BAX 855 infusion. Here number of participants analyzed refers to the number of participants evaluable for this outcome.|||Months||Full Range|Median
2621501|NCT01945593|Secondary|BAX 855 Infusions Needed to Treat Bleeding Episodes|The BAX 855 infusions to treat each bleeding episode was determined by the participant, the participant's caregiver, and/or investigator, and was based upon the participant's response to treatment. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII.|Baseline through end of study (53 months)|FAS included all participants with at least 1 BAX 855 infusion.|||Infusions||Standard Deviation|Mean
2621502|NCT01945593|Secondary|Overall Hemostatic Efficacy Rating of BAX 855 for Treatment of Breakthrough Bleeding Episodes|The participant or caregiver rated the overall treatment response at 24 (+/- 2) hours after the initiation of treatment using a 4-point efficacy rating scale as Excellent: Full relief of pain and cessation of objective signs of bleeding after a single infusion and no additional infusion is required for the control of bleeding; Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion and possibly requires more than 1 infusion for complete resolution; Fair: Slight relief of pain and slight improvement in signs of bleeding after a single infusion and required more than 1 infusion for complete resolution and None: No improvement or condition worsens.|Baseline through end of study (53 months)|FAS included all participants with at least 1 BAX 855 infusion. Here ‘N’ refers to the number of participants evaluable for this outcome.|||Treated bleeds|||Number
2621503|NCT01945593|Secondary|Total Annualized Bleed Rate (ABR)|The ABR was assessed based upon each individual bleeding episode. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII. Bleeding occurring at multiple locations related to the same injury (e.g., knee and ankle bleed following a fall) was counted as a single bleeding episode. Total annualized bleed rate (spontaneous and traumatic bleeding episodes) was reported.|Baseline through end of study (53 months)|FAS included all participants with at least 1 BAX 855 infusion.|||Bleeds per year||Standard Deviation|Mean
2621504|NCT01945593|Primary|Annualized Bleed Rate (ABR) - Spontaneous Bleeds|The ABR was assessed based upon each individual bleeding episode. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII. The ABR of spontaneous bleeds was reported separately for twice weekly, PK-t R, each of the every 5 days and every 7 days treatment regimens at the time of bleed.|Baseline through end of study (53 months)|Full analysis set (FAS) included all participants with at least 1 BAX 855 infusion.|||Bleeds per year||95% Confidence Interval|Median
2621505|NCT01945593|Primary|Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII)|Inhibitory antibodies to Factor VIII were measured by the Nijmegen modification of the Bethesda assay. Inhibitors had to be confirmed by 2 separate assessments within a 2 to 4 week period from the central laboratory.|Baseline through end of study (53 months)|Safety analysis set (SAS) included all participants with at least 1 BAX 855 infusion. The analysis included participants that developed inhibitory antibodies (IA) to FVIII and participants that did not develop IA to FVIII and had 100 or more exposure days (ED) to BAX 855 across all studies and a FVIII inhibitory test result after the 100th ED.|||Participants|||Count of Participants
2621506|NCT01945489|Secondary|Change From Baseline in the Daily Average Number of Nocturia Episodes|Nocturia episodes were recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of nocturia episodes were averaged daily during this period. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from Baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 12|Participants from the Intent-to-Treat Population, all participants who were randomized to study drug, with data available at Baseline and Week 12.|||nocturia episodes||Standard Deviation|Mean
2621507|NCT01945489|Secondary|Change From Baseline in the Daily Average Number of Urgency Episodes|The number of daily urgency episodes (the number of times a patient experiences the urgency to urinate) in Treatment Cycle 1 was recorded by the patient in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of urgency episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.|Baseline, Week 12|Participants from the Intent-to-Treat Population, all participants who were randomized to study drug, with data available at Baseline and Week 12.|||urgency episodes||Standard Deviation|Mean
2621508|NCT01945489|Secondary|Change From Baseline in the Daily Average Number of Micturition Episodes|The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of micturition episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.|Baseline, Week 12|Participants from the Intent-to-Treat Population, all participants who were randomized to study drug, with data available at Baseline and Week 12.|||micturition episodes||Standard Deviation|Mean
2621509|NCT01945489|Secondary|Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores|The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of participants with urinary incontinence. The questionnaire consists of 7 domains, including emotions, personal relationships, physical limitations, role limitations, severity (coping) measures, sleep/energy and social limitations. Domain scores range from 0 to 100, with a lower score indicating a preferable health status (absence of urinary incontinence impacts). A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates a worsening.|Baseline, Week 12|"Intent-to-Treat Population included all participants who were randomized to study drug, n is the number of participants with available data at the given time-point."|||score on a scale||Standard Deviation|Mean
2621510|NCT01945489|Primary|Change From Baseline in the Daily Average Number of Episodes of Urinary Incontinence|Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period. A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.|Baseline, Week 12|Participants from the Intent-to-Treat Population, all participants who were randomized to study drug, with data available at Baseline and Week 12.|||incontinence episodes||Standard Deviation|Mean
2621511|NCT01945489|Primary|Percentage of Participants Who Achieve a 100% Reduction in Urinary Incontinence Episodes|Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period and compared to baseline to determine 100% reduction in episodes.|Baseline, Week 12|Participants from the Intent-to-Treat Population, all participants who were randomized to study drug, with data available at Baseline and Week 12.|||percentage of participants|||Number
2621512|NCT01945294|Secondary|Percentage of Participants With Treatment-Related Serious AEs (SAEs)|A SAE is any AE that results in death, is life threatening, results in persistent or significant disability, results in or prolongs an existing inpatient hospitalization, is a congenital birth defect, is a cancer, is associated with an overdose, or is another important medical event.|Up to 60 weeks|The APaT includes all participants who received ≥1 dose of study drug.|||Percentage of Participants|||Number
2621513|NCT01945294|Secondary|Percentage of Participants With Dose Discontinuation Due to Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. The percentage of participants who discontinued from BOC, BOC + RBV, or all medications due to an AE are reported.|From TW1 through TW48|The APaT includes all participants who received ≥1 dose of study drug.|||Percentage of Participants|||Number
2621516|NCT01945294|Secondary|Percentage of Participants With Relapse|The percentage of viral relapse (defined as confirmed HCV RNA >15 IU/mL after End-of-Treatment [EOT]) among participants who had undetectable HCV RNA at EOT was determined for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.|From EOT to FW12 (up to 12 weeks)|Participants in the FAS with undetectable HCV RNA at EOT and who have data available at FW12 were included.|||Percentage of Participants|||Number
2621517|NCT01945294|Secondary|Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment|The percentage of participants achieving SVR12 who had undetectable HCV RNA (HCV RNA <LLoQ) at Week 4, Week 8, and Week 12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.|TW4, TW8, and TW12|The subset of the FAS population consisting of all participants treated with any study medication in Arms 1, 2, and 3 and who had undetectable HCV RNA at Week 4, Week 8, or Week 12.|||Percentage of Participants|||Number
2621518|NCT01945294|Secondary|Percentage of Participants With Undetectable HCV RNA Across Treatment|The percentage of participants with undetectable HCV RNA (HCV RNA <LLoQ) at TW4, TW8, and TW12 is summarized for each arm. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.|TW4, TW8, and TW12|Participants in the FAS population (consisting of all participants treated with any study medication who had undetectable HCV RNA at TW8 and were randomized to Arm 1 or Arm 2, and participants with detectable HCV RNA at TW8 in Arm 3) with available data.|||Percentage of Participants|||Number
2621519|NCT01945294|Primary|Percentage of Participants With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm]|SVR12 was declared when participants who had undetectable HCV RNA (HCV RNA < Lower Limit of Quantification [LLoQ]) after the 12-week lead-in also had undetectable HCV RNA 12 weeks after completing their assigned BOC treatment regimen. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.|Follow-up Week (FW) 12 (up to 40 weeks)|Participants of the Full Analysis Set (FAS) who were treated with any study medication, had undetectable HCV RNA at TW8, and were randomized to Arm 1 or Arm 2. Participants in Arm 3 were not included in the primary efficacy analysis as pre-specified by the protocol.|||Percentage of Participants|||Number
2621520|NCT01945281|Secondary|Number of Participants With an Adverse Event (AE)|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.|8 weeks after end of study therapy (up to 146 days)|All participants as treated|||Participants|||Count of Participants
2621521|NCT01945281|Secondary|Percentage of Participants With Fungal-free Survival Through the End of Study Treatment|Fungal-free survival is those participants who survived up to end of study treatment, and had documented microbiological eradication of Candida sp. from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved.|Up to 90 days|Participants who received at least 1 full dose of study therapy and had a documented (culture-confirmed) diagnosis of invasive candidiasis.|||Percentage of Participants||95% Confidence Interval|Number
2621522|NCT01945281|Primary|Percentage of Participants With Fungal-free Survival Through the 2-week Post-therapy Period|Fungal-free survival is those participants who survived up to 2 weeks post-therapy, and had documented microbiological eradication of Candida species (sp.) from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved.|Up to 104 days|Participants who received at least 1 full dose of study therapy and had a documented (culture-confirmed) diagnosis of invasive candidiasis.|||Percentage of Participants||95% Confidence Interval|Number
2621523|NCT01945242|Secondary|Change From Baseline in Fasting Insulin|The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.|||mg/dL||Standard Deviation|Mean
2621524|NCT01945242|Secondary|Change From Baseline in Fasting Blood Glucose|The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2621525|NCT01945242|Secondary|Percentage of Participants of Achieving Objective Glycemic Control|The rate of achieving objective glycemic control in HbA1c level, was calculated at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as <8.0 percent, <7.0 percent, and <6.0 percent of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.|||percentage of participants|||Number
2621651|NCT01944098|Primary|Postoperative Pain|Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain|24 hours post-surgery||||units on a scale||Full Range|Median
2621526|NCT01945242|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the thiazolidinedione treatment.|Baseline, Months 1, 3, 6, 12, and final assessment (up to 12 months)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2621527|NCT01945242|Primary|Number of Participants Reporting One or More Serious Adverse Drug Reactions|Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
2621528|NCT01945242|Primary|Number of Participants Reporting One or More Adverse Drug Reactions|Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + thiazolidinedione and alogliptin + other arm separately.|Baseline up to 12 months|The safety analysis set was defined as all participants who were enrolled and completed the study.|||participants|||Number
2621529|NCT01945216|Secondary|Change From Baseline in Fasting Blood Glucose|The change in the value of fasting blood glucose collected at month 36 relative to baseline.|Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. Reported group were Alogliptin and Alogliptin + α-GI and data for Alogliptin + Other were not collected as specified in protocol.|||mg/dL||Standard Deviation|Mean
2621530|NCT01945216|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at month 36 relative to baseline.|Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36)|The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. Reported group were Alogliptin and Alogliptin + α-GI and data for Alogliptin + Other were not collected as specified in protocol.|||Percent||Standard Deviation|Mean
2621531|NCT01945216|Primary|Number of Participants Who Experience at Least One Adverse Events||Up to Month 36|Safety Analysis Set was defined as all participants who were enrolled and completed the study.|||Participants|||Count of Participants
2621532|NCT01945138|Secondary|Day 28 Follow-Up: C-Peptide||Day 28 Follow-Up||||ng/mL||Standard Deviation|Mean
2621533|NCT01945138|Secondary|Day 28 Follow-Up: Average Serum BG||Day 28 Follow-Up||||mg/dL||Standard Deviation|Mean
2621534|NCT01945138|Secondary|Day 14 Follow-Up: C-Peptide||Day 14 Follow-Up:||||ng/mL||Standard Deviation|Mean
2621535|NCT01945138|Secondary|Day 14 Follow-Up: Average Serum BG||Day 14 Follow-Up||||mg/dL||Standard Deviation|Mean
2621536|NCT01945138|Secondary|Study Period: Daily Insulin Needs|Calculated as total daily dose of insulin.|Average of 3 day study period||||U/kg/day||Standard Deviation|Mean
2621537|NCT01945138|Secondary|Study Period: Morning C-peptide|A single C-peptide measurement collected daily x 3 days, collected at random (meaning not in a fasting state) each morning. Expressed as average for each patient.|Average of 3 day study period||||ng/mL||Standard Deviation|Mean
2621538|NCT01945138|Secondary|Study Period: % of Time CGM BG > 140 mg/dL||continuous over the 72 hour investigation period||||% of time||95% Confidence Interval|Mean
2621539|NCT01945138|Secondary|Study Period: CGM AUC With Glucose> 140 mg/dL||continuous over the 72 hour investigation period||||min*mg/dL/day||Standard Deviation|Mean
2621540|NCT01945138|Secondary|Study Period: % of Time CGM BG <70 mg/dL||continuous over the 72 hour investigation period||||% of time||95% Confidence Interval|Mean
2621541|NCT01945138|Secondary|Study Period: CGM Area Under the Curve (AUC) With Glucose < 70 mg/dL|Calculated as the area under the curve on the CGM tracing that the glucose is under 70 mg/dL.|continuous over the 72 hour investigation period||||min*mg/dL/day||Standard Deviation|Mean
2621542|NCT01945138|Secondary|Study Period: Percent Time BG in Range 70-140 mg/dL|Additional measure of glycemic variability, as reflected by CGM measures, % time in the range of 70-140 on CGM|continuous over the 72 hour investigation period||||% of time||95% Confidence Interval|Mean
2621543|NCT01945138|Secondary|Study Period: Continuous Glucose Monitor Standard Deviation of BG|measure of glycemic variability by CGM. This is the standard deviation within each patient for all CGM glucose readings.|continuous over the 72 hour investigation period||||mg/dL||Standard Deviation|Mean
2621544|NCT01945138|Secondary|Study Period: Continuous Glucose Monitor (CGM) BG Average|Continuous glucose monitoring sensor data: The CGM's in the pump and control groups will collect glucose readings continuously over a 72 hour period|continuously over the 72 hour investigational period||||mg/dL||Standard Deviation|Mean
2621545|NCT01945138|Primary|Study Period: Serum BG Standard Deviation|Measure of glycemic variability. This is the standard deviation in all serum BG values for each individual patient.|3 days of investigation period||||mg/dL||Standard Deviation|Mean
2621546|NCT01945138|Primary|Study Period: Average Serum BG|Mean blood glucose value: a single report of the average of the analytical blood glucose values will be computed and compared between the pump and control groups.|3 days of investigation period||||mg/dL||Standard Deviation|Mean
2621547|NCT01945112|Primary|Count of Participants With Any Foot Blister in Taped or Untaped Area of the Foot|Blister data were collected without regard to whether the foot was right or left.|within 7 days of application of tape||||Participants|||Count of Participants
2621548|NCT01945086|Secondary|Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 to 3 where 0=none, 1=mild, 2=moderate, 3=severe, on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Baseline, Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.|||participants|||Number
2621549|NCT01945086|Secondary|Percent Change From Baseline of Body Region Scores in EASI|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.|||percent change||Standard Deviation|Mean
2621550|NCT01945086|Secondary|Percent Change From Baseline in EASI Sign of Disease Components|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.|||percent change||Standard Deviation|Mean
2621551|NCT01945086|Secondary|Percent Change From Baseline in EASI Total Score|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively. LOCF method was not applied to impute the missing data.|||percent change||Standard Deviation|Mean
2621552|NCT01945086|Secondary|Number of Participants in IGA|The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).|Baseline, Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.|||participants|||Number
2621553|NCT01945086|Secondary|Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline|The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.|||participants|||Number
2621554|NCT01945086|Secondary|"Number of Participants With an IGA Score of Clear or Almost Clear"|The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).|Baseline, Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.|||participants|||Number
2621555|NCT01945086|Secondary|Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline|The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Week 2, 4, 8, 12, 16, 20 and 24|FAS population was used for analysis. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.|||participants|||Number
2621556|NCT01945086|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12|The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.|Baseline and Week 12|FAS included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. LOCF method was used to impute the missing data.|||units on a scale||Standard Deviation|Mean
2621557|NCT01945086|Secondary|Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12|The atopic dermatitis itch scale (ADIS) will be used to assess pruritus (itching) among participants with AD. It will be evaluated by participant diary kept twice daily,in the morning(morning daily score[MDS]) and evening (Evening Daily Score[EDS]). The start-of-day item set consists of 4 items:itching at time of completing morning diary(Q1),presence of itching during night before(Q2), itching at its worst at night (Q3), and impact of itching on sleep at night(Q4). Appropriate items are summed to yield total score ranging from 0=minimum to 23=maximum, with higher scores reflecting greater itching. The end-of day item set also consists of 4 items: itching at time of completing the evening diary(Q1),the presence of itching during the day(Q2),itching at its worst during the day(Q3),and amount of time the participant experienced eczema-related itching(Q4). Appropriate items are summed to yield total score ranging from 0=minimum to 24=maximum,with higher scores reflecting greater itching.|Baseline and Week 12|FAS population was used for analysis. LOCF method was used to impute the missing data. ‘N’ (Number of Participants Analyzed) signifies number of participants who were evaluable for this outcome measure. ‘n’ signifies number of participants who were evaluable at each specific time point for each arm respectively.|||units on a scale||Standard Deviation|Mean
2621558|NCT01945086|Secondary|"Number of Participants With an Investigator's Global Assessment (IGA) Score of Clear or Almost Clear at Week 12"|The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).|Week 12|FAS included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. LOCF method was used to impute the missing data.|||participants|||Number
2621559|NCT01945086|Primary|Percent Change in Eczema Area Severity Index (EASI) Total Score From Baseline at Week 12|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than [>] 90 percent [%]-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.|Baseline and Week 12|Full Analysis Set (FAS) included all randomized participants with at least 1 study agent administration irrespective of whether the participant received the assigned treatment, and had at least 1 postdose EASI assessment. Last Observation Carried Forward (LOCF) method was used to impute the missing data.|||percent change||Standard Deviation|Mean
2621560|NCT01945034|Secondary|Percentage of Participants Taking Rescue Medication|Participants used only acetaminophen at a dose of 500 mg every 6 hours PRN as analgesia or rescue therapy during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary.|Post first dose Day 1 up to Day 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||Percentage of participants|||Number
2621561|NCT01945034|Secondary|Number of Doses of Rescue Medication Used During the First 7 Days of Dosing|Participants received only acetaminophen 500 mg every 6 hours PRN as rescue medication during the course of the study.|Baseline up to Day 7|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||Doses||Standard Deviation|Mean
2621562|NCT01945034|Secondary|Time to Rescue Medication After Initial Dose, and After Each Subsequent Dose|Participants used only acetaminophen at a dose of 500 milligram (mg) every 6 hours product as needed (PRN) as rescue medication during the course of the study. Participants who used acetaminophen were to record its use, and date and time of administration in the participant diary. Time to rescue medication after initial dose, after each subsequent dose, provided that in each dose interval at least 25% of the participants take rescue medication was analyzed using the proportional hazard model with site, treatment group, and baseline categorical ankle pain terms in the model.|Post-Dose on Day 1 up to Day 10|Data was not analyzed since <20% participants used rescue medication.||||||
2621563|NCT01945034|Secondary|Time to First Perceptible Relief and Meaningful Relief|"Participants evaluated time to first perceptible relief by stopping a stopwatch labelled 'first perceptible relief' at moment participant first began to experience any relief, exact question asked was: Stop stopwatch when you first begin to feel any pain-relieving effect whatsoever of product; that is, when you first feel a little relief. First perceptible relief was considered confirmed by meaningful relief if participant achieved both first perceptible and meaningful relief by either pressing second stopwatch or by indicating that his/her first perceptible relief was also meaningful. For time to meaningful relief, exact question asked was: Stop this stopwatch when you have meaningful relief; that is, when relief from pain is meaningful to you. Stopwatches were active up to 3 hours after dosing or until stopped by participant, or rescue medication was administered."|0 to 3 hours on Day 1|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||Minutes||95% Confidence Interval|Median
2621652|NCT01944098|Primary|Postoperative Pain|Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain - 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting|18 hours post-surgery||||units on a scale||Full Range|Median
2621564|NCT01945034|Secondary|Participant's Global Assessment of Medication at End of Study|Participants Global Assessment of Medication was used to rate the medication as a pain reliever. The responses of participants were recorded using 5-point scale: 1= Very Poor, 2= Poor, 3= Fair, 4= Good, 5= Very Good. The global assessment of medication scores for each question range from 0 to 5, giving a possible score range of 0 - 5, with higher scores indicating medication as a better pain reliever.|Day 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment. Number of participants analyzed 'N' signifies those participants who were evaluable for the measure.|||Units on a scale||Standard Deviation|Mean
2621565|NCT01945034|Secondary|Change From Baseline in Participant Assessment of Normal Function and Activity at Day 3 and 10|Participant assessment of normal function was measured using a 5-point scale: 1= Normal walking/activity and no pain; 2= Normal walking/activity with pain; 3= Mildly restricted walking due to pain and can't resume normal activities; 4= Moderately restricted walking due to pain and can't resume normal activities; 5= Severely restricted walking due to pain and can't resume normal activities. The normal functioning and activity scores for each question range from 1 to 5, with higher scores indicating worsening of normal activity.|Baseline, Day 3, 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||Units on a scale||Standard Error|Least Squares Mean
2621566|NCT01945034|Secondary|Sum of Pain Intensity Difference Scores at Rest and on Weight Bearing Over 7 Days|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 7 days (168 hours). Total score ranges from -840 (higher pain relief) to 1008 (lower pain relief). SPID is a value of change from baseline. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|Over 7 days (0-168 hours)|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||Units on a scale||Standard Error|Least Squares Mean
2621567|NCT01945034|Secondary|Sum of Pain Intensity Difference Scores at Rest Over 3 Days|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|Over 3 Days (0-72 hours)|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||Units on a scale||Standard Error|Least Squares Mean
2621568|NCT01945034|Secondary|Sum of Pain Intensity Difference at Rest and on Weight Bearing Over 6 Hours on Day 1 and Over 2 Hours on Day 3|PI at rest and on weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID 0-6 was calculated as the time-weighted sum of PID scores over 6 hours on Day 1, with a total score ranges from -30 (higher pain relief) to 36 (lower pain relief). SPID 0-12 was calculated as the time weighted sum of PID scores over 2 hours on Day 3, with a total score ranges from -10 (higher pain relief) to 12 (lower pain relief). SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|Over 6 hours on Day 1, over 2 hours on Day 3|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2621569|NCT01945034|Secondary|Change From Baseline in Ankle Pain at Rest and Upon Weight Bearing (PID NRS) at Pre-specified Time Points|PI in ankle pain at rest and upon weight bearing was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. Pain score at baseline is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline.|Baseline, 1, 2, 3, 4, 5, 6, 12(Day1),24(Day2),30(Day2),36(Day2),48(Day3),50(Day3),54(Day3),60(Day3),72(Day4),78(Day4),84(Day4), 96(Day5),102(Day5), 108 (Day5), 120(Day6),126(Day6),132(Day6),144(Day7),150(Day7),156(Day7) hours post first dose on Day 1|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2621570|NCT01945034|Secondary|Change From Baseline in Physician Global Assessment of Ankle Injury at Day 3 and 10|The physician assessment of the severity of the ankle injury was based on the participant's individual signs and symptoms which included pain, swelling, tenderness and limitation of range of movement, and was measured using 6-point scale: 0= Normal (No signs or symptoms) , 1= Very mild (Very mild signs and symptoms), 2= Mild (Mild signs and symptoms), 3= Moderate (Moderate signs and symptoms), 4= Severe (Severe signs and symptoms), 5= Very severe (Very severe signs and symptoms). A higher score is indicative of lesser improvement. Change from baseline was calculated as baseline value minus post-treatment value.|Baseline, Day 3, 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2621571|NCT01945034|Secondary|Change From Baseline in Participant's Global Assessment of Ankle Injury at Day 3 and 10|Participant's global assessments of ankle injury was measured using 5-point scale: 1= Very Good (No symptoms and no limitations of normal activities), 2= Good (Mild symptoms and no limitation of normal activities), 3= Fair (Moderate symptoms and limitations of some normal activities), 4= Poor (Severe symptoms and inability to carry out most normal activities), 5= Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).|Baseline, Day 3, 10|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2621572|NCT01945034|Secondary|Sum of Pain Intensity Difference at Rest Over 24 Hours on Day 1 (SPID R24)|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -240 (higher pain relief) to 96 (lower pain relief) for SPID at rest. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|0 to 24 hours|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2621573|NCT01945034|Primary|Sum of Ankle Pain Intensity Difference on Weight Bearing Over 24 Hours After Dose 1 (SPID WB24)|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 24 hours. Total score ranges from -120 (higher pain relief) to 144 (lower pain relief) for SPID WB24. SPID is a value of change from baseline. Pain score at base line is usually higher than that at post baseline. So negative value of SPID indicates pain relief from baseline, while a positive value means a worst pain comparing to baseline, a negative value of SPID indicates higher pain relief from baseline.|0 to 24 hours|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2621574|NCT01945034|Primary|Sum of Pain Intensity Difference (SPID) on Weight Bearing Over 3 Days (SPID WB0-3)|PI was assessed on an 11-point numerical rating scale from 0=no pain to 10=most severe pain. Pain intensity difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted sum of PID scores over 3 days (72 hours). Total score ranges from -360 (higher pain relief) to 432 (lower pain relief) for SPID WB0-3. SPID is a value of change from baseline and as pain score at base line is usually higher than that at post baseline, a negative value of SPID indicates higher pain relief from baseline.|Over 3 Days (0-72 hours)|The full analysis set included all randomized participants who dosed with the study medication and provided a baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2621575|NCT01945021|Secondary|Change From Baseline Scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13|The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed specific symptoms (dyspnea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use. Negative change from baseline scores indicated an improvement in symptoms, decreased functioning, or decreased global QOL, while positive change from baseline scores indicated an improvement in functioning, improvement in global QOL, or a worsening of symptoms. Scores on each sub-scale range from 0 - 100. A clinically meaningful change was defined as a >/= 10-point change in mean scores. Changes were described as statistically significant if the 95% CI for the change did not include 0.|From the date of informed consent every 8 weeks or 12 weeks until cycle 8|Number of participants that had both a baseline assessment and an assessment at cycle 8|||units on a scale||Standard Deviation|Mean
2621576|NCT01945021|Secondary|Change From Baseline Scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30)|The QLQ-C30 consists of 30 questions which are incorporated into 5 functional domains (physical, role, cognitive, emotional, and social domains); a global health status/global QOL scale; 3 symptom scales (fatigue, pain, nausea and vomiting scales); and 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and the perceived financial burden of treatment. Scores for each sub-scale range from 0 to 100. Negative change from baseline scores indicated an improvement in symptoms, decreased functioning, or decreased global QOL, while positive change from baseline scores indicated an improvement in functioning, improvement in global QOL, or a worsening of symptoms. A clinically meaningful change was defined as a >/= 10-point change in mean scores. Changes were described as statistically significant if the 95% CI for the change did not include 0.|From the date of informed consent every 8 weeks or 12 weeks until cycle 8|Number of participants that had both a baseline assessment and an assessment at cycle 8|||units on a scale||Standard Deviation|Mean
2621577|NCT01945021|Secondary|Number of Patients With a Shift of Chemistry Laboratory Results From Grade </= 2 to Grade 3 or Grade 4|A summary of the number of patients in the safety population with available laboratory data whose chemistry laboratory results shifted from a baseline value of Grade </=2 to a post-baseline result of Grade 3 or Grade 4|From time of baseline screening test every 4, 8, or 12 weeks until 28 days from last dose of study treatment||||participants|||Number
2621578|NCT01945021|Secondary|Number of Patients With a Shift in Hematology Laboratory Results From Grade </=2 to Grade 3 or Grade 4|A summary of the number of patients in the safety population with available laboratory data whose hematology laboratory results shifted from a baseline value of Grade </=2 to a post-baseline result of Grade 3 or Grade 4|From time of baseline screening test every 4, 8, or 12 weeks until 28 days from last dose of study treatment||||participants|||Number
2621579|NCT01945021|Secondary|Type, Incidence, Severity, Seriousness and Relationship to Study Medications of Adverse Events (AE) and Any Laboratory Abnormalities|Incidence of patients experiencing a treatment emergent adverse events were summarized by type, incidence, severity, seriousness and relationship to study medication.|From the date of signed informed consent, then a minimum of every 4 weeks until 32 weeks, then a minimum of every 8 weeks, or until 4 weeks after last dose of treatment||||percentage of patients|||Number
2621580|NCT01945021|Secondary|Overall Survival||Assessed from date of date of the first dose of crizotinib until the date of death from any cause, assessed up to 6 months after the last subject is enrolled on the trial|OS is defined as the time from the date of the first dose of crizotinib to the date of death due to any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.|||months||95% Confidence Interval|Median
2621653|NCT01944098|Primary|Postoperative Pain|Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain - 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting|12 hours post-surgery||||units on a scale||Full Range|Median
2621581|NCT01945021|Secondary|Progression Free Survival Assessed by Independent Radiology Review|Progression Free Survival is defined as the time from the date of the first dose of crizotinib to first documentation of objective disease progression or to death on study due to any cause, whichever occurs first. Patients who had neither progression nor death without objective progression were censored at the time of data cut off.|From the date of first dose of crizotinib every 8 weeks or 12 weeks until the first documentation of objective disease progression or death||||months||95% Confidence Interval|Median
2621582|NCT01945021|Secondary|Disease Control Rate at 8 Weeks by Independent Radiology Review|The Disease Control Rate at 8 weeks is defined as the number of patients with a confirmed CR, confirmed PR, or SD at 8 weeks, respectively, according to RECIST v1.1 (as determined by IRR), relative to the total population of response evaluable patients.|Measured once at 8 weeks after the start of study treatment||||participants|||Number
2621583|NCT01945021|Secondary|Time to First Response|Time to response is defined as the time from the date of first dose to first documentation of objective tumor response (CR or PR), as assessed by Independent Radiology Review, that is subsequently confirmed. For patients proceeding from PR to CR, the onset of PR is taken as the onset of response.|From date of first dose of crizotinib every 8 weeks or 12 weeks until first documentation of objective response is observed, until 6 months after the last subject is enrolled on the trial|Analysis is based on 88 patients who achieved an objective response as assessed by Independent Radiology Review|||months||Full Range|Median
2621584|NCT01945021|Secondary|Duration of Response by Independent Review|The time from the first documentation of objective tumor response (CR or PR) according to Independent Review and that was subsequently confirmed to the first documentation of objective disease progression or to death due to any cause, whichever occurs first. It was calculated for the response evaluable population in the subgroup of patients with a confirmed objective response and who had a subsequent event of progression or death without progression. Patients who did not meet these criteria were censored on the date of the last on-study tumor assessment.|Every 8 or 12 weeks until 6 months after the last patient was enrolled in the trial|Duration of response was calculated for the response evaluable population in the subgroup of patients with a confirmed objective response by Independent Review and who either subsequently had objective progression or died, whichever occurred first.|||months||Standard Deviation|Mean
2621585|NCT01945021|Primary|Independent Radiology Reviewed Overall Objective Response (ORR)|Overall Objective Response (ORR) was defined as the number of patients with a best overall response of confirmed Complete Response or confirmed Partial Response according to RECIST v1.1 (as determined by Independent Radiology Review [IRR]), relative to the total population of response-evaluable patients (n=127). Confirmed responses were those that persisted on repeat imaging at least 4 weeks after the initial documentation of response.|Starting from the first dose study treatment until the first documented CR or PR.||||participants|||Number
2621586|NCT01944969|Secondary|Change in Health-related Quality of Life|The EuroQoL 5 Dimensions 5L version (EQ-5D-5L) Visual Analogue Scale (VAS) is a patient-reported assessment designed to measure the patient's wellbeing. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a visual analogue scale (VAS) of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems) and a single summary index (from 0 to 1) can be calculated. The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).|Baseline and Week 52|No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.||||||
2621587|NCT01944969|Secondary|Change in Health-related Quality of Life|Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-(SF)) total score|From baseline to Week 52|No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.||||||
2621588|NCT01944969|Secondary|Change in Clinical Global Impression|Clinical Global Impression - Severity of illness (CGI-S) score|From baseline to Week 52|No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.||||||
2621589|NCT01944969|Secondary|Proportion of Patients in Remission|Based on a pre-specified MADRS total score|From baseline to Week 52|No patients completed the study. Only 26 patients were enrolled at prematurely study termination (Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.||||||
2621590|NCT01944969|Secondary|Change in Depressive Symptoms|The Montgomery and Aasberg Depression Rating Scale (MADRS) total score|From baseline to Week 52|None of the patients completed the study. A total of 26 patients were enrolled when the study was prematurely terminated(Planned: 1184 patients). No data were collected because none of the 26 patients that were enrolled completed the study because of early termination.||||||
2621591|NCT01944969|Secondary|Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)|The Columbia Suicide Severity Rating Scale (eC-SSRS) is a semi-structured interview developed to systematically assess suicidal ideation and behaviour of patients participating in a clinical study. The C-SSRS has 5 questions addressing suicidal ideation, 5 sub-questions assessing the intensity of ideation, and 4 questions addressing suicidal behaviour. The electronic C-SSRS (eC-SSRS) is a patient-rated electronic version using interactive voice response technology. A structured CSSRS script of standardised questions, follow-up prompts, error-handling and scoring conventions is used for administration.|From baseline to Week 52|all-patients treated set (APTS)|||participants|||Number
2621592|NCT01944969|Primary|Number of Withdrawals|Number of withdrawals|From baseline to Week 52|26 patients were withdrawn; the reason for withdrawal was not poor tolerability, but mainly (23 patients) because the study was terminated. Please see withdrawn reasons in the participant flow section for the other reasons.|||participants|||Number
2621593|NCT01944969|Primary|Number of Participants With Treatment-Emergent Adverse Events|Number of participants with Treatment-Emergent Adverse Events|From baseline to Week 52||||participants|||Number
2621594|NCT01944878|Secondary|The Association Between PUD and HVPG in Patients With Chronic Hepatitis||Retrospective case-control study (from 2009 to 2012, up to 3 years)||||mmHg||Inter-Quartile Range|Median
2621595|NCT01944878|Primary|The Association of HVPG and PUD in Patients With Liver Cirrhosis|"The association of hepatic vein pressure gradient that reflects portal hypertension and peptic ulcer disease in patients with liver cirrhosis was assessed statistically.~(NO specific time frame, only confined to 2009 to 2012, when the HVPG measurement was done). The Mann-Whitney test was used to evaluate the association between PUD or not and HVPG degree, by SPSS software."|Retrospective case-control study (from 2009 to 2012, up to 3 years)||||mmHg||Inter-Quartile Range|Median
2621596|NCT01944839|Primary|Mean Change in Visual Acuity From Baseline to 12 Months|The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline to the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.|12 Months||||letters||Standard Error|Mean
2621597|NCT01944774|Secondary|Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population|Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.|||participants|||Number
2621598|NCT01944774|Secondary|Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population|Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.|||participants|||Number
2621599|NCT01944774|Secondary|Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population|Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.|||participants|||Number
2621600|NCT01944774|Secondary|Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population|Only subjects whose bacterial culture from visit 1 was positive would be evaluated for the overall efficacy. The overall efficacy (cured or ineffective) at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model.|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.|||participants|||Number
2621601|NCT01944774|Secondary|Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population|"Microbiological efficacy at visits 3 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:~Subjects whose respiratory culture from visit 1 was positive;~Subjects whose blood culture from visit 1 was positive.~The microbiological efficacy at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model."|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.|||participants|||Number
2621602|NCT01944774|Secondary|Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population|"Microbiological efficacy at visits 3 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:~Subjects whose respiratory culture from visit 1 was positive;~Subjects whose blood culture from visit 1 was positive.~The microbiological efficacy at Visit 3 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model."|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.|||participants|||Number
2621603|NCT01944774|Secondary|Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population|"Microbiological efficacy at visits 4 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:~Subjects whose respiratory culture from visit 1 was positive;~Subjects whose blood culture from visit 1 was positive.~The microbiological efficacy at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model."|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the b-mITT population who conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the BE population.|||participants|||Number
2621604|NCT01944774|Secondary|Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population|"Microbiological efficacy at visits 4 would be determined by assessing the identification results from the central laboratory. Subjects must satisfy at least one of the following in order to be evaluated for the microbiological efficacy:~Subjects whose respiratory culture from visit 1 was positive;~Subjects whose blood culture from visit 1 was positive.~The microbiological efficacy at Visit 4 and treatment group (determined by each subject) was determined by the number and percentage of microbiological success subjects. The difference in bacteriological success between Nemonoxacin malate sodium chloride injection and Moxifloxacin Hydrochloride Sodium Chloride Injection was tested using the logistic regression model."|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the mITT population whose bacterial culture yielded at least one baseline bacterial isolate were enrolled into the b-mITT population.|||participants|||Number
2621605|NCT01944774|Secondary|Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population|The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 3 in the CE population. At visit 3, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than ‒15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the mITT population that conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the CE population.|||participants|||Number
2621606|NCT01944774|Secondary|Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population|The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 3 in the mITT population. At visit 3, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than ‒15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.|Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug)|Subjects in the ITT population that met the minimal disease criteria, and was evaluated for clinical efficacy at least once were enrolled into the mITT population.|||participants|||Number
2621607|NCT01944774|Secondary|Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the Clinically Evaluable (CE) Population|The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 4 in the CE population. At visit 4, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than ‒15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the mITT population that conformed to the protocol analysis plan with no major violation to the protocol were enrolled into the CE population.|||participants|||Number
2621608|NCT01944774|Primary|Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population|The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 4 in the mITT population. At visit 4, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than ‒15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.|Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)|Subjects in the ITT population that met the minimal disease criteria, and was evaluated for clinical efficacy at least once were enrolled into the mITT population.|||participants|||Number
2621609|NCT01944722|Primary|Number of Participants With Cervical Intraepithelial Neoplasia (CIN)2 or Greater and CIN3 or Greater Within Each Cytology Category.|Prevalence is calculated as the rate of CIN2 or greater and CIN3 or greater within each cytology category.|Up to 14 weeks||||Participants|||Count of Participants
2621610|NCT01944722|Primary|Non-reportable Rate of the BD Onclarity™ HPV Test|Non-reportable rate is calculated as the number of non-reportable BD Onclarity™ HPV test results divided by the total number of BD Onclarity™ HPV test results (multiplied by 100). Not included in this calculation are specimens that did not yield a result due to specimen labeling, processing and volume issues.|Up to 14 weeks||||percentage of participants|||Number
2621611|NCT01944722|Primary|Negative Percent Agreement of the BD Onclarity™ HPV Assay Compared to a Composite HPV Comparator Incorporating Results for the Digene HC2 HPV Test and PCR/Sequencing on Both Strands of the PCR Amplicon (Bidirectional Sequencing)|Negative percent agreement is calculated: Number of subjects with a negative BD Onclarity™ HPV test with composite comparator negative divided by the total number of subjects with composite comparator negative (multiplied by 100).|Up to 14 weeks||||percentage of participants||95% Confidence Interval|Number
2621612|NCT01944722|Primary|Positive Percent Agreement of the BD Onclarity™ HPV Assay as Compared to a Composite HPV Comparator Incorporating Results for the Digene Hybrid Capture 2 (HC2) HPV Test and PCR/Sequencing on Both Strands of the PCR Amplicon (Bidirectional Sequencing)|Positive percent agreement is calculated: Number of subjects with a positive BD Onclarity™ HPV test with composite comparator positive divided by the total number of subjects with composite comparator positive (multiplied by 100).|Up to 14 weeks||||percentage of participants||95% Confidence Interval|Number
2621613|NCT01944722|Primary|Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).|Relative Risk is the ratio between two different absolute risks. The relative risk of having CIN3 or greater disease will be evaluated to compare two different BD Onclarity™ HPV Assay test outcomes.|Up to 14 weeks||||ratio||95% Confidence Interval|Number
2621614|NCT01944722|Primary|Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).|Relative Risk is the ratio between two different absolute risks. The relative risk of having CIN2 or greater disease will be evaluated to compare two different BD Onclarity™ HPV Assay test outcomes.|Up to 14 weeks||||ratio||95% Confidence Interval|Number
2621615|NCT01944722|Primary|Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).|The Absolute Risk (AR) of CIN3 or greater disease for each BD Onclarity™ HPV test outcome is the probability of the disease for that particular BD Onclarity™ HPV test outcome. A higher absolute risk indicates a higher probability overall for an event to occur.|Up to 14 weeks||||percentage of assays||95% Confidence Interval|Number
2621616|NCT01944722|Primary|Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).|The Absolute Risk (AR) of CIN2 or greater disease for each BD Onclarity™ HPV test outcome is the probability of the disease for that particular BD Onclarity™ HPV test outcome. A higher absolute risk indicates a higher probability overall for an event to occur.|Up to 14 weeks||||percentage of assays||95% Confidence Interval|Number
2621617|NCT01944722|Primary|Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).|The likelihood ratio for each BD Onclarity™ HPV test outcome summarizes how many times more (or less) likely subjects with CIN3 or greater disease are to have that particular BD Onclarity™ HPV test outcome than subjects without the disease. Significant likelihood ratios (defined in cases where 1 is not contained within the 95% confidence interval) indicate that a test result is informative.|Up to 14 weeks||||Ratio||95% Confidence Interval|Number
2621618|NCT01944722|Primary|Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).|The likelihood ratio for each BD Onclarity™ HPV test outcome summarizes how many times more (or less) likely subjects with CIN2 or greater disease are to have that particular BD HPV Onclarity™ test outcome than subjects without the disease. Significant likelihood ratios (defined in cases where 1 is not contained within the 95% confidence interval) indicate that a test result is informative.|Up to 14 weeks||||Ratio||95% Confidence Interval|Number
2621619|NCT01944722|Primary|Negative Predictive Value (NPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN).|Negative Predictive Value is calculated: Number of subjects with a negative result for the BD Onclarity™ HPV test and histology results less than CIN2 divided by the total number of subjects with negative results for the BD Onclarity™ HPV test (multiplied by 100). Similar for CIN3 or greater.|Up to 14 weeks||||percentage of participants||95% Confidence Interval|Number
2621620|NCT01944722|Primary|Positive Predictive Value (PPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN).|Positive Predictive Value is calculated: Number of subjects with a positive result for the BD Onclarity™ HPV test and adjudicated histology results of CIN2 or greater divided by the total number of subjects with positive result for the BD Onclarity™ HPV test (multiplied by 100). Similar for CIN3 or greater.|Up to 14 weeks|Data includes all participants with evaluable data.|||percentage of participants||95% Confidence Interval|Number
2621621|NCT01944722|Primary|Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater|Specificity is calculated: Number of subjects with a negative BD Onclarity™ HPV test with adjudicated histology results of CIN3 or greater divided by the total number of subjects with adjudicated histology results of less than CIN3 (multiplied by 100).|Up to 14 weeks||||percentage of participants||95% Confidence Interval|Number
2621622|NCT01944722|Primary|Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater|Specificity is calculated: Number of subjects with a negative BD Onclarity™ HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of less than CIN2 (multiplied by 100).|Up to 14 weeks||||percentage of participants||95% Confidence Interval|Number
2621623|NCT01944722|Primary|Sensitivity of the BD Onclarity™ HPV Assay for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater|Sensitivity is calculated: Number of subjects with a positive BD Onclarity™ HPV test with adjudicated histology results of CIN3 or greater divided by the total number of subjects with adjudicated histology results of CIN3 or greater (multiplied by 100).|Up to 14 weeks||||percentage of participants||95% Confidence Interval|Number
2621624|NCT01944722|Primary|Sensitivity of the BD Onclarity™ HPV Assay for the Detection Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater|Sensitivity is calculated: Number of subjects with a positive BD Onclarity™ HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of CIN2 or greater (multiplied by 100).|Up to 14 weeks||||percentage of participants||95% Confidence Interval|Number
2621625|NCT01944670|Primary|Recurrent Dislocations|"To confirm that the Internal Joint Stabilizer - Elbow (IJS-E) provides temporary stabilization of the elbow joint and allows functional recovery after trauma or chronic dislocation.~The study is deemed a success if the at least 75% of patients do not have a recurrent dislocation while using the IJS-E or after removal of the IJS-E."|8 months (6 month post-explant)|Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data). Excludes patients who were lost to follow-up.|||Participants|||Count of Participants
2621626|NCT01944670|Primary|Broberg Morrey Functional Rating|"To confirm that the Internal Joint Stabilizer - Elbow (IJS-E) provides temporary stabilization of the elbow joint and allows functional recovery after trauma or chronic dislocation.~The study is deemed a success if the at least 75% of patients receive a Broberg Morrey Functinoal Rating of Fair or better."|Eight months (6 months post-explant)|Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data). Excludes patients who were lost to follow-up.|||Participants|||Count of Participants
2621627|NCT01944644|Primary|Positive and Negative Affect Score (PANAS) - Positive Subscale|The Positive and Negative Affect Schedule (PANAS) measures both positive affect and negative affect. Participants in the PANAS are required to respond to two 20-item subscales using 5-point scale that ranges from very slightly or not at all (1) to extremely (5). This positive subscale captures self-rated scale of symptoms of depression ranging from 0-50 (higher score means worse depression).|7 days after baseline||||units on a scale||Standard Deviation|Mean
2621628|NCT01944644|Primary|Positive and Negative Affect Score (PANAS) - Negative Subscale|The Positive and Negative Affect Schedule (PANAS) measures both positive affect and negative affect. Participants in the PANAS are required to respond to two 20-item subscales using 5-point scale that ranges from very slightly or not at all (1) to extremely (5). This negative subscale captures self-rated scale of symptoms of depression ranging from 0-50 (higher score means worse depression).|7 days after baseline||||units on a scale||Standard Deviation|Mean
2621629|NCT01944644|Primary|Visual Analog Scale|A Visual Analog Scale is a measurement of subjective characteristics that cannot be directly measured. Using this self questionnaire, subjects specify their level of depression along a continuous line between two end-points ranging from 0-100 (higher score means better mood).|7 days after baseline||||units on a scale||Standard Deviation|Mean
2621630|NCT01944644|Primary|6 Item Hamilton Depression Rating Scale|This is to compare the 6 Item Hamilton Depression Rating Scale from the Screen to after 3 Sessions of Active or Sham LFMS (7 days post-baseline). The Hamilton Scale for Depression 6 item subscale scores range from 0-24. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.|7 days after baseline||||units on a scale||Standard Deviation|Mean
2621631|NCT01944631|Secondary|Patient Overall Assessment of Efficacy|"Patient overall assessment of efficacy was assessed by the question How effective was the treatment in relieving your common cold symptoms? at day 10. A 5-point scale was used (0=poor, 1=fair, 2=good, 3=very good, 4=excellent)."|Day 10|FAS|||percentage of participants|||Number
2621632|NCT01944631|Secondary|Duration of the Cold|"Duration of the common cold was assessed by the question Do you still have a cold? at the end of each treatment day. The duration of the cold was defined as ended by the first day of a No answer to this daily question."|Baseline up to 10 days|FAS|||days||95% Confidence Interval|Median
2621633|NCT01944631|Secondary|Area Under the Curve (AUC) Over the 10-day Period for the TSS (AUC-TSS 1-10)|"The total symptom score (TSS) is the sum of the 8 single common cold symptom scores consisting of 3 systemic (headache, muscle ache and chilliness) and 5 local (sore throat, blocked nose, runny nose, cough and sneezing) symptoms.~Each common cold symptom was scored on a 4-point ordinal scale:~0 = symptom not present~1 = mild symptom (I can feel it but it has not disturbed or irritated me)~2 = moderate symptom (symptom has disturbed and irritated me some of the time)~3 = severe symptom (symptom has disturbed and irritated me most of the time)~The Area under the curve (AUC) over the 10-day period for the total symptom score (AUC-TSS 1-10) was calculated as the sum of the TSS calculated on each day from day 1 to day 10. AUC-TSS 1-10 ranges from 0 (no symptoms) to 270 (severe symptoms)."|Days 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10|FAS|||units on a scale * days||Standard Error|Least Squares Mean
2621634|NCT01944631|Secondary|Mean of the Sum of 5 Single Local Common Cold Symptom Scores Mean Over Days 2 to 4 (LSS2-4)|"The mean of the sum of 5 single local common cold symptom scores (sore throat, blocked nose, runny nose, cough and sneezing).~Each common cold symptom was scored on a 4-point ordinal scale:~0 = symptom not present~1 = mild symptom (I can feel it but it has not disturbed or irritated me)~2 = moderate symptom (symptom has disturbed and irritated me some of the time)~3 = severe symptom (symptom has disturbed and irritated me most of the time)~The mean of the sum of 5 single local common cold symptom scores over days 2 to 4 was calculated as (LSS2 + LSS3 + LSS4)/3 where LSS2, LSS3 and LSS4 are the local common cold symptom scores calculated for days 2, 3 and 4 respectively. LSS2-4 ranges from 0 (no symptoms) to 15 (severe symptoms)."|Days 2, 3 and 4|FAS|||units on a scale||Standard Error|Least Squares Mean
2621635|NCT01944631|Secondary|Mean of the Sum of 3 Single Systemic Common Cold Symptom Scores Over Days 2 to 4 (SSS2-4)|"The mean of the sum of 3 single systemic common cold symptom scores (headache, muscle ache, chilliness).~Each common cold symptom was scored on a 4-point ordinal scale:~0 = symptom not present~1 = mild symptom (I can feel it but it has not disturbed or irritated me)~2 = moderate symptom (symptom has disturbed and irritated me some of the time)~3 = severe symptom (symptom has disturbed and irritated me most of the time)~The mean of the sum of 3 single systemic common cold symptom scores over days 2-4 was calculated as (SSS2 + SSS3 + SSS4)/3 where SSS2, SSS3 and SSS4 are the systemic common cold symptom scores calculated for days 2, 3 and 4 respectively. SSS2-4 ranges from 0 (no symptoms) to 9 (severe symptoms)."|Days 2, 3 and 4|FAS|||units on a scale||Standard Error|Least Squares Mean
2621654|NCT01944098|Primary|Postoperative Pain|Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain|6 hours post-surgery||||units on a scale||Full Range|Median
2621655|NCT01944059|Secondary|HIT-6|Differences in the scores for the HIT-6 disability inventory between baseline and the last study visit will be analyzed.|4-6 months|Study funding ended prematurely. Blinding information not provided by Funder. Data analysis was not completed.||||||
2622233|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3)||Visit 4 (Month 3)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||participants|||Number
2621636|NCT01944631|Primary|Total Symptom Score (TSS) Over Days 2 to 4 (TSS2-4)|"The total symptom score (TSS) is the sum of the 8 single common cold symptom scores consisting of 3 systemic (headache, muscle ache and chilliness) and 5 local (sore throat, blocked nose, runny nose, cough and sneezing) symptoms.~Each common cold symptom was scored on a 4-point ordinal scale:~0 = symptom not present~1 = mild symptom (I can feel it but it has not disturbed or irritated me)~2 = moderate symptom (symptom has disturbed and irritated me some of the time)~3 = severe symptom (symptom has disturbed and irritated me most of the time)~The mean over days 2 to 4 (TSS2-4) was calculated as (TSS2 + TSS3 + TSS4)/3 where TSS2, TSS3 and TSS4 are the total symptom scores calculated for days 2, 3 and 4 respectively. TSS2-4 ranges from 0 (no symptoms) to 24 (severe symptoms)."|Days 2, 3 and 4|Full analysis set (FAS) which included all randomised patients who used at least one dose of trial treatment, who provided a baseline total symptom score (TSS) as well as any post-treatment data for the primary endpoint.|||units on a scale||Standard Error|Least Squares Mean
2621637|NCT01944462|Secondary|Pharmacist Satisfaction|Pharmacists who participated in the intervention were surveyed to determine their satisfaction with the program, including: 1) satisfaction with live action skit, 2) belief that PPPP was successful in educating participants, 3) belief that PPPP was successful in building trust in pharmacists among participants, 4) belief that PPPP was successful in increasing acceptance of pharmacists as immunizers, and 5) belief that PPPP will decrease barriers to vaccination among participants.|3 months||||Participants|||Count of Participants
2621638|NCT01944462|Secondary|Intervention Cost|"Measures PPPP intervention costs per participant. Consists of total program costs divided by number of participants. Value reported is the per-participant cost with measure type number."|3 months||||$/participant|||Number
2621639|NCT01944462|Secondary|Satisfaction With PPPP|Satisfaction with PPPP was measured as participants' overall satisfaction with the content of PPPP, extent to which the participant felt engaged, and belief that the program helped them learn about pneumonia and the vaccination.|3 months|Intention-to-treat (ITT) sample|||Participants|||Count of Participants
2621640|NCT01944462|Secondary|Activation|Activation was measured as number of participants having taken action at 3 months or planning action at baseline, post-test, and 3 months.|3 months|Intention-to-Treat (ITT) sample, subset not reporting positive history of pneumococcal vaccination at baseline|||Participants|||Count of Participants
2621641|NCT01944462|Secondary|Trust in Pharmacists as Vaccine Providers|Trust in pharmacists as vaccine providers were measured by comparing responses to the trust items in the baseline, post-test (immediately following intervention), and 3-month assessments. Trust items were coded on a 4-level Likert scale, with lower values corresponding to higher agreement with the trust statements (therefore a lower mean response indicates greater trust). Minimum possible score was 1 (indicating complete trust in pharmacists as vaccine providers) and maximum possible score was 4 (indicating complete lack of trust in pharmacists as vaccine providers).|Baseline, post-test (immediately following intervention), 3 months|Intention-to-Treat (ITT) sample|||units on a scale||Standard Deviation|Mean
2621642|NCT01944462|Primary|Knowledge and Awareness of Pneumococcal Disease|"Change in knowledge and awareness of pneumococcal disease over time were assessed for the following domains: susceptibility to infection, symptoms of disease, severity of illness, and vaccination with an emphasis on vaccine efficacy, safety, and eligibility. Assessments at baseline, post-test (immediately following intervention), and 3 months using the Pneumonia Knowledge Questionnaire, an instrument developed by investigators to assess participants' knowledge and awareness in the domains of interest. Instrument consists of 5 mark all that apply items and one mark the best response item. Scores range from 0 (no correct responses) to 28 (all responses correct), with a higher score value corresponding to better knowledge and awareness."|Baseline, post-test, 3 months|Intention-to-treat (ITT) sample|||scores on a scale||Standard Deviation|Mean
2621643|NCT01944345|Secondary|Radiological Assessment|Determination of fusion assessment, subsidence or migration of the device and confirmed radiographic dated|Post-operative follow up|26 (of 30) Cervical Patients 30 (of 39) Lumbar Patients|||participants|||Number
2621644|NCT01944345|Primary|Change in VAS Pain|"VAS Pain comparison Preoperative vs post-operative of greater than or equal to 6.~VAS PAIN SEVERITY SCALE ranges from 0-10. A score of zero (0) means 'no pain' and a ten (10) means 'worst imaginable pain'"|Pre-operative and Post-operative 12 months|Total subjects: 30 Cervical subjects, 39 Lumbar subjects. VAS PAIN SEVERITY SCALE ranges from 0-10. Zero = no pain, 10 - worst imaginable pain|||Units on a scale 0-10||Standard Deviation|Mean
2621645|NCT01944345|Primary|Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50|ODI/NDI Score Range: 0-50 0-4 No disability 5-14 Mild disability 15-24 Moderate disability 25-34 Severe disability >34 Complete disability|Pre-operative and Post-operative 12 months post-operative|Combined cervical and lumbar patients: 30 cervical, 39 lumbar. Mean ODI/NDI was calculated for all patients at preop and 12 month.|||Units on a scale 0-50||Standard Deviation|Mean
2621646|NCT01944319|Secondary|Bacteriological Success Rate|"The bacterial success or failure will be evaluated at the end of meropenem therapy.~Bacteriological success including eradication and presumed eradication. Bacteriological failure including persistence and presumed persistence."|At the end of meropenem therapy, an average of 10 days.||||participants|||Number
2621647|NCT01944319|Secondary|Amount of Used Antibiotics|Record the amount of antibiotics usage during antibiotic therapy|participants will be followed for the duration of antibiotic therapy, an average of 10 days||||grams||Inter-Quartile Range|Median
2621648|NCT01944319|Primary|Clinical Success Rate|"The clinical success or failure of meropenem therapy will be evaluated one week after stop of antibiotic therapy.~Clinical success was defined as cure or improvement of all signs and symptoms caused by the infection and no requirement for additional antibacterial therapy.~Clinical failure was defined as a persistence or worsening of any new clinical sign or symptom, development of any new clinical signs or symptoms of infection, or the requirement for other systemic antimicrobial therapy at the end of meropenem therapy."|One week after antibiotic therapy finished.||||participants|||Number
2621649|NCT01944293|Secondary|Change in Systolic Blood Pressure|Blood pressure is measured in millimeters of mercury.|During study infusion||||mm Hg||Standard Deviation|Mean
2621656|NCT01944059|Secondary|Percent Change in Migraine and Headache Frequency|The percent change in migraine and headache frequency will be defined as [frequency/baseline phase - frequency/treatment phase] divided by [frequency/baseline phase].|4-6 months|Study funding ended prematurely. Blinding information not provided by Funder. Data analysis was not completed.||||||
2621658|NCT01943864|Secondary|Number of Participants With Independent Radiologist Assessed Duration of Response|Duration of response was summarized for participants with a confirmed CR or PR and is defined as the time (in weeks) from the initial response (CR/PR) to first documented disease progression or death due to any cause. If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population with a time to response event. Only 1 participant reached PR therefore estimated time to response cannot be presented. At the data cut off, this patient is censored. Therefore, the observed value of duration of response is unknown.|||Participants|||Number
2621659|NCT01943864|Secondary|Number of Participants With Investigator-Assessed Duration of Response|Duration of response was summarized for participants with a confirmed CR or PR and is defined as the time (in weeks) from the initial response (CR/PR) to first documented disease progression or death due to any cause. If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population with a time to response event.|||Participants|||Number
2621660|NCT01943864|Secondary|Number of Weeks Until Time to Response Assessed With Independent Radiologist|Time to response (TTR) event was defined as achievement of a confirmed CR or PR, as the time from date of randomization until date of first documented evidence of CR or PR (whichever status is recorded first). If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, progression free survival (PFS) in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment. Only 1 participant reached PR therefore estimated time to response cannot be presented. The time to response for this patient is presented as the actual number of weeks to PR.|Up to Week 37|ITT Population. Only 1 participant reached PR therefore estimated time to response cannot be presented. The time to response for this patient is presented as the actual number of weeks to PR.|||Weeks|||Number
2621661|NCT01943864|Secondary|Number of Participants With Investigator-Assessed Time to Response|Time to response (TTR) event was defined as achievement of a confirmed CR or PR, as the time from date of randomization until date of first documented evidence of CR or PR (whichever status is recorded first). If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, progression free survival (PFS) in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population.||||||
2621662|NCT01943864|Secondary|Number of Participants With Overall Response Rate as Assessed by Independent Radiologist Per RECIST 1.1 Criteria|Overall Response Rate (ORR) is defined as the number of participants achieving a confirmed CR or PR per RECIST 1.1 criteria from the start of treatment until disease progression or the start of new anti-cancer therapy. ORR was based on responses from the Independent Radiologist assessment of best overall response, the best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. ORR is calculated as CR + PR.|Up to Week 37|ITT Population.|||Participants|||Number
2621663|NCT01943864|Secondary|Number of Participants With Overall Response Rate as Assessed by Investigator Per RECIST 1.1 Criteria|Overall Response Rate (ORR) is defined as the number of participants achieving a confirmed CR or PR per RECIST 1.1 criteria from the start of treatment until disease progression or the start of new anti-cancer therapy. ORR was based on responses from the Investigator assessment of best overall response, the best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. ORR is calculated as CR + PR.|Up to Week 37|ITT Population.|||Participants|||Number
2621664|NCT01943864|Secondary|Number of Participants With Overall Survival|Overall Survival (OS) is defined as the interval of time (in weeks) between the date of randomization and the date of death due to any cause. For participants that did not die, time of death was censored at the date of last contact. The date of death was taken from that recorded on the Record of Death page. Death on study due to any cause was included. One year OS was calculated from Kaplan-Meier estimates.|Up to Week 39|ITT Population.|||Participants|||Number
2621665|NCT01943864|Secondary|Number of Participants With Progression-Free Survival as Assessed by Independent Radiologist|Progression-Free Survival (PFS) is defined as the interval of time (in weeks) between the date of randomization and the earlier of the date of disease progression and the date of death due to any cause. Disease progression was based on the assessments by the independent radiologist. If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population.|||Participants|||Number
2621666|NCT01943864|Secondary|Number of Participants With Progression-Free Survival as Assessed by Investigator|Progression-Free Survival (PFS) is defined as the interval of time (in weeks) between the date of randomization and the earlier of the date of disease progression and the date of death due to any cause. Disease progression was based on the assessments by the Investigator. If a participant received subsequent anti-cancer therapy prior to the date of documented progression or death, PFS in the participant was censored at the last adequate assessment prior the initiation of the new anti-cancer therapy. Otherwise, if a participant did not have a documented date of progression or death, PFS in the participant was censored at the last adequate assessment.|Up to Week 37|ITT Population.|||Participants|||Number
2621697|NCT01943799|Secondary|Change From Baseline in HBsAg at Week 48|The change from baseline to Week 48 in HBsAg was analyzed using a MMRM. The model included included treatment, HBsAg baseline level (≤ 1000 IU/mL or > 1000 IU/mL), HBeAg baseline status (positive or negative), visit, and treatment-by-visit interaction as fixed effects and visit as a repeated measure.|Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||95% Confidence Interval|Least Squares Mean
2621667|NCT01943864|Secondary|Change From Baseline in Oxygen Saturation (SpO2)|Oxygen Saturation was measured at Baseline (Day 1), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32 and Week 36. For records occurring after baseline, change from baseline was calculated as the post baseline value minus the baseline value. When either the baseline or visit value was missing, the change from baseline was considered to be missing.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Percent oxygen saturation||Standard Deviation|Mean
2621668|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Pulse Rate|Pulse rate was categorized as Decrease to <60, Change to Normal or No Change, and Increase to >100. Change from baseline was calculated as the post baseline value minus the baseline value. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Participants with missing baseline measurements or visit measurements were considered to be missing.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
2621669|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Blood Pressure|Systolic and diastolic blood pressure was measured after sitting for at least 5 minutes. Systolic blood pressure (SBP) was categorized as: Grade 0 (<120), Grade 1 (>=120-<140), Grade 2 (>=140-<160) and Grade 3 (>=160). Diastolic blood pressure (DBP) was categorized as Grade 0 (<80), Grade 1 (>=80-<90), Grade 2 (>=90-<100), and Grade 3 (>=100). Change from baseline was calculated as the post baseline value minus the baseline value. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Participants with missing baseline measurements or visit measurements were considered to be missing.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
2621670|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Body Temperature|Body temperature was categorized as Decrease to <=35; Change to Normal or No Change and Increase to >=38. Change from baseline was calculated as the post baseline value minus the baseline value. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Participants with missing baseline measurements or visit measurements were considered to be missing.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
2621671|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Carcinoembryonic Antigen Measurements With Respect to the Normal Range|Change from baseline was calculated as the post baseline value minus the baseline value for carcinoembryonic antigen (CEA). A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Measurements were designated as either Decreased to Low (DTL) or Increased to High (ITH) or Change to Normal/No Change (CN/NC). Participants with missing baseline measurements or visit measurements were considered to be missing. Participants were counted twice if the participant Decreased to Low and Increased to High.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
2621672|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Hematology Measurements With Respect to the Normal Range|Change from baseline was calculated as the post baseline value minus the baseline value for basophils, eosinophils, and monocytes. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Measurements were designated as either Decreased to Low (DTL) or Increased to High (ITH) or Change to Normal/No Change (CN/NC). Participants with missing baseline measurements or visit measurements were considered to be missing. Participants were counted twice if the participant Decreased to Low and Increased to High.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
2621673|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Prothrombin Time Measurements With Respect to the Normal Range|Change from baseline was calculated as the post baseline value minus the baseline value for prothrombin time (PT). A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Measurements were designated as either Decreased to Low (DTL) or Increased to High (ITH) or Change to Normal/No Change (CN/NC). Participants with missing baseline measurements or visit measurements were considered to be missing. Participants were counted twice if the participant Decreased to Low and Increased to High.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
2621683|NCT01943825|Secondary|Number of Participants With Solicited Systemic Reactions|A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the eCRF and considered as related to vaccination. Solicited systemic reactions: fever, headache, malaise, myalgia, and asthenia.|Within 14 days after any CYD dengue vaccine and/or JE vaccine|Analysis was performed on safety analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||Participants|||Count of Participants
2621674|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Clinical Chemistry Measurements With Respect to the Normal Range|Change from baseline was calculated as the post baseline value minus the baseline value for cancer antigen 19-9 (CA 19-9), chloride, lactate dehydrogenase (LDH), and urea. A Worst Post Baseline (WPB) change is defined as the worst change that occurred at any measured timepoint during the treatment period. Measurements were designated as either Decreased to Low (DTL) or Increased to High (ITH) or Change to Normal/No Change (CN/NC). Participants with missing baseline measurements or visit measurements were considered to be missing. Participants were counted twice if the participant Decreased to Low and Increased to High.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
2621675|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Hematology Grade Shifts From Baseline|Shift from baseline was calculated as the post baseline value minus the baseline value for hemoglobin, lymphocytes, neutrophils, platelets, and leukocytes. A Worst Post Baseline (WPB) grade shift is defined as the worst change that occurred at any measured timepoint during the treatment period. Grading was determined by the NCI Common Terminology Criteria for Adverse Events Version 3.0 (NCI-CTCAE). Participants with missing baseline grade were designated a baseline grade of 0.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
2621676|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Coagulation Grade Shifts From Baseline|Shift from baseline was calculated as the post baseline value minus the baseline value for activated partial thromboplastin time (APTT) and prothrombin time (PT). A Worst Post Baseline (WPB) grade shift is defined as the worst change that occurred at any measured timepoint during the treatment period. Grading was determined by the NCI Common Terminology Criteria for Adverse Events Version 3.0 (NCI-CTCAE). Participants with missing baseline grade were designated a baseline grade of 0.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
2621677|NCT01943864|Secondary|Number of Participants With the Indicated Worst-case On-therapy Clinical Chemistry Grade Shifts From Baseline|Shift from baseline was calculated as the post baseline value minus the baseline value for albumin, alkalaine phosphatase (AP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, creatine kinase (CK), creatinine, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, and phosphate. A Worst Post Baseline (WPB) grade shift is defined as the worst change that occurred at any measured timepoint during the treatment period. Grading was determined by the NCI Common Terminology Criteria for Adverse Events Version 3.0 (NCI-CTCAE). Participants with missing baseline grade were designated a baseline grade of 0.|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Participants|||Number
2621678|NCT01943864|Secondary|Expression of Interstitial Lung Disease Marker Surfactant Protein D|Interstitial lung disease marker Surfactant Protein D assessments were carried out at Baseline (Day 1), Week 12, and Week 28|Baseline, Week 12, and Week 28|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed (represented by n=x).|||Micrograms per litre (µ/L)||Standard Deviation|Mean
2621679|NCT01943864|Secondary|Expression of Interstitial Lung Disease Marker KL-6|Interstitial lung disease markers KL-6 assessments were carried out at Baseline (Day 1), Week 12, Week 20, Week 24, Week 28, Week 32, and Week 36|From Baseline up to Week 36|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period. Only those participants with analyzable data at the indicated time point were assessed.|||Units/milliliter (U/mL)||Standard Deviation|Mean
2621680|NCT01943864|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or Protocol-Specific SAEs|until 26-Feb-2016|ITT Population.|||Participants|||Number
2621681|NCT01943864|Primary|Number of Participants With Indicated Non-progressive Disease as Assessed by Independent Radiologist Per Response Evaluation Criteria In Solid Tumor Version 1.1 (RECIST 1.1) at Week 12|Twelve week non-progressive disease (PD) at Week 12 was evaluated by computed tomography. Non- PD was calculated as the sum of complete response (CR), partial response (PR), and stable disease (SD).|Up to Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.|||Participants|||Number
2621682|NCT01943864|Primary|Number of Participants With Indicated Non-progressive Disease as Assessed by Investigator Per Response Evaluation Criteria In Solid Tumor Version 1.1 (RECIST 1.1) at Week 12|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions; Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease(PD), At least a 20% increase in the sum of the diameters of target lesions. Non-PD = CR + PR + SD.|Up to Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.|||Participants|||Number
2624512|NCT01923480|Secondary|Plasma Concentration of Arginine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
2621684|NCT01943825|Secondary|Number of Participants With Solicited Injection Site Reactions|A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the electronic case report form (eCRF) and considered as related to vaccination. Solicited injection site reactions: pain, erythema, and swelling.|Within 7 days after any CYD dengue vaccine and/or JE vaccine|Analysis was performed on safety analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||Participants|||Count of Participants
2621685|NCT01943825|Secondary|Geometric Means Titers of Antibodies Against Japanese Encephalitis - Groups 3 and 4|GMTs of antibodies against JE were measured by JE micro neutralization assay. The LLOQ of the assay was a titer of 10 (1/dilution).|Pre-injection 1, and 28 days post-injection 1, 2 and 3|Analysis was performed on full analysis set. Here, ‘Number analyzed’ = participants with available data for each specified category.|||titers (1/dilution)||95% Confidence Interval|Geometric Mean
2621686|NCT01943825|Secondary|Number of Participants With Detectable Serotype-Specific Vaccine Viremia|Viremia was determined by RT PCR using primer/probes specific to each dengue vaccine serotypes.|3, 5, 7 and 14 days post-injection 1; 3 and 14 days post-injection 2 and 7 days post-injection 3|Analysis was performed on full analysis set. Here, ‘Number analyzed’ = participants with available data for each specified category.|||Participants|||Count of Participants
2621687|NCT01943825|Secondary|Number of Participants With Detectable Non Serotype-Specific Vaccine Viremia|Viremia was determined by reverse transcriptase (RT) polymerase chain reaction (PCR) using primer/probes specific to a non serotype-specific part of the dengue vaccine.|3, 5, 7 and 14 days post-injection 1, 2 and 3|Analysis was performed on full analysis set. Here, ‘Number analyzed’ = participants with available data for each specified category.|||Participants|||Count of Participants
2621688|NCT01943825|Secondary|Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains|GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT.|6 months and 12 months post-injection 3|Analysis was performed on full analysis set. Here, ‘Number analyzed’ = participants with available data for each specified category. Data was not planned to be collected and analyzed for Groups 2 and 4 for 12 months post-injection 3 time point.|||titers (1/dilution)||95% Confidence Interval|Geometric Mean
2621689|NCT01943825|Secondary|Geometric Means Titers of Antibodies Against Each Dengue Virus Serotype Strains in Participants Who Received Japanese Encephalitis Vaccine - Groups 3 and 4|GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT. The LLOQ of the assay was a titer of 10 (1/dilution).|Pre-injection 1, 2 and 3, and 28 days post-injection 1, 2 and 3|Analysis was performed on full analysis set. Here, ‘Number analyzed’ = participants with available data for each specified category.|||titers (1/dilution)||95% Confidence Interval|Geometric Mean
2621690|NCT01943825|Primary|Number of Participants With Antibody Titers Greater Than or Equal to (>=)10 (1/Dilution) Against Each Dengue Virus Serotype Strains|Antibody titers against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by PRNT.|Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3|Analysis was performed on full analysis set. Here, ‘Number analyzed’ = participants with available data for each specified category.|||Participants|||Count of Participants
2621691|NCT01943825|Primary|Geometric Means Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Strains|GMTs of antibodies against each dengue virus serotype (parental strains 1, 2, 3 and 4) were measured by plaque reduction neutralization test (PRNT). The lower limit of quantitation (LLOQ) of the assay was a titer of 10 (1/dilution).|Pre-injection 1, 2 and 3; 28 days post-injection 1, 2 and 3; and 6 months post-injection 3|Analysis was performed on full analysis set which included participants who received at least one injection of CYD dengue vaccine or JE vaccine and had at least one blood sample drawn and valid post-injection serology result. Here, ‘Number analyzed’ = participants with available data for each specified category.|||titers (1/dilution)||95% Confidence Interval|Geometric Mean
2621692|NCT01943799|Secondary|Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48|HBsAg 1-log decline was defined as ≥ 1 decline from baseline in log10 IU/mL serum HBsAg at any postbaseline visit within the targeted time window.|Baseline; Weeks 12, 24, and 48|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2621693|NCT01943799|Secondary|Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 48|HBeAg loss was defined as a qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAb seroconversion was defined as a qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit.|Week 48|Participants in the Full Analysis Set with positive HBeAg at baseline were analyzed.|||percentage of participants|||Number
2621694|NCT01943799|Secondary|Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 24|HBeAg loss was defined as a qualitative HBeAg result changing from positive at baseline to negative at any postbaseline visit. HBeAb seroconversion was defined as a qualitative HBeAb result changing from negative at baseline to positive at any postbaseline visit.|Week 24|Participants in the Full Analysis Set with positive HBeAg at baseline were analyzed.|||percentage of participants|||Number
2621695|NCT01943799|Secondary|Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48|HBsAg loss was defined as HBsAg level decreasing from >0.066 IU/mL at baseline to ≤ 0.066 IU/mL at any postbaseline visit. HBsAb seroconversion was defined as HBsAb level increasing from < 12 mIU/mL at baseline to ≥ 12 mIU/mL at any postbaseline visit.|Week 48|Participants in the Full Analysis Set with HBsAg Level above 0.066 IU/mL at Baseline were analyzed.|||percentage of participants|||Number
2621696|NCT01943799|Secondary|Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24|HBsAg loss was defined as HBsAg level decreasing from >0.066 IU/mL at baseline to ≤ 0.066 IU/mL at any postbaseline visit. HBsAb seroconversion was defined as HBsAb level increasing from < 12 mIU/mL at baseline to ≥ 12 mIU/mL at any postbaseline visit.|Week 24|Participants in the Full Analysis Set with HBsAg Level above 0.066 IU/mL at Baseline were analyzed.|||percentage of participants|||Number
2621727|NCT01943474|Secondary|Patient Satisfaction With Overall IV Performance|Patient satisfaction with overall IV performance at IV removal using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.|At IV removal (usually after 1-7 days of IV dwell time)||||units on a scale||Standard Deviation|Mean
2621698|NCT01943799|Secondary|Change From Baseline in HBsAg at Week 12|The change from baseline to Week 12 in HBsAg was analyzed using a MMRM. The model included included treatment, HBsAg baseline level (≤ 1000 IU/mL or > 1000 IU/mL), HBeAg baseline status (positive or negative), visit, and treatment-by-visit interaction as fixed effects and visit as a repeated measure.|Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||95% Confidence Interval|Least Squares Mean
2621699|NCT01943799|Primary|Change From Baseline in HBsAg at Week 24|The change from baseline to Week 24 in HBsAg was analyzed using a mixed effect model for repeated measures (MMRM). The model included included treatment, HBsAg baseline level (≤ 1000 IU/mL or > 1000 IU/mL), HBeAg baseline status (positive or negative), visit, and treatment-by-visit interaction as fixed effects and visit as a repeated measure.|Baseline; Week 24|Participants in the Full Analysis Set (participants who were randomized and had a Baseline/Day 1 visit for Treatment Group A or have received at least 1 dose of GS-4774 for Treatment Group B, C, and D) with available data were analyzed. Participants were analyzed according to the randomized treatment assignment.|||log10 IU/mL||95% Confidence Interval|Least Squares Mean
2621700|NCT01943591|Primary|Related Mortality|Mortality that precludes follow up|Within 1 year following coiling||||Participants|||Count of Participants
2621701|NCT01943591|Secondary|Modified Rankin Score (mRS) Greater Than 2|Modified Rankin Score (mRS) that is greater than 2 at 1 year follow-up (or at last follow-up, if applicable). Minimum = 0 (no symptoms), maximum = 6 (Deceased).|at 1 year follow-up||||Participants|||Count of Participants
2621702|NCT01943591|Secondary|Procedural Serious Adverse Events (SAEs)|Procedural-related serious adverse events|Within 6 months following coiling||||Participants|||Count of Participants
2621703|NCT01943591|Secondary|Packing Density|Packing density with the number of coils implanted|within the first 3 days after coiling||||percentage of packing density||Standard Deviation|Mean
2621704|NCT01943591|Primary|Related Morbidity|Morbidity that precludes follow up|Within 1 year following coiling||||Participants|||Count of Participants
2621705|NCT01943591|Primary|Initial Treatment Failure|Inability to treat aneurysm, either because access to aneurysm is difficult or technical issues.|Within 1 year following coiling||||Participants|||Count of Participants
2621706|NCT01943591|Primary|Retreatment of the Same Lesion by Endovascular or Surgical Means|Retreatment of the same lesion by endovascular or surgical means during the follow-up period|Within 1 year following coiling||||Participants|||Count of Participants
2621707|NCT01943591|Primary|Hemorrhage During the Follow-up Period|Post-treatment hemorrhage experienced during follow-up period.|Within 1 year following coiling||||Participants|||Count of Participants
2621708|NCT01943591|Primary|Major Recurrence of Lesion or Presence of Residual Aneurysm|Major radiographic recurrence of the lesion or the presence of a 'residual aneurysm' as judged by core lab|1 year||||Participants|||Count of Participants
2621709|NCT01943565|Secondary|Intraoperative Vasopressor Use: Phenylephrine Equivalents|"IT (intrathecal ) applied local anesthetics and opioids can cause arterial and venous vasodilation leading to a decrease in afterload as well as preload. This is typically treated with volume replacement and vasopressors (acutely).~Total intraoperative vasopressor use will be reported for phenylephrine equivalents."|Intraoperatively (at time of operation)|One 25 mcg patient is missing data on this outcome|||mcg||Standard Deviation|Mean
2621710|NCT01943565|Secondary|Intraoperative Vasopressor Use: Ephedrine Equivalents|IT (intrathecal) applied local anesthetics and opioids can cause arterial and venous vasodilation leading to a decrease in afterload as well as preload. This is typically treated with volume replacement and vasopressors (acutely). Total intraoperative vasopressor use will be reported for ephedrine equivalents.|Intraoperatively (at time of operation)|One 25 mcg patient is missing data on this outcome|||mg||Standard Deviation|Mean
2621711|NCT01943565|Secondary|Number of Patients With Pruritus|IT opioids can cause pruritus. Persistent pruritus requiring treatment will be recorded.|24hrs post administration of IT hydromorphone|One 25 mcg patient is missing data on this outcome|||Participants|||Count of Participants
2621712|NCT01943565|Secondary|Number of Patients With Visual Disturbances|IT/IV opioids can create visual disturbances. The number of patients with visual disturbances are reported.|24hrs post administration of IT hydromorphone||||Participants|||Count of Participants
2621713|NCT01943565|Secondary|Number of Patients With Hypothermia (Body Temperature < 95F/35C)|intrathecally administered opioids can cause hypothermia (body temperature <95F/35C)|24hrs post administration of IT hydromorphone|One 25 mcg patient was missing data on this measure|||Participants|||Count of Participants
2621714|NCT01943565|Secondary|Patients With Nausea and Vomiting Requiring Rescue Medication|IV and IT opioids can induce nausea and vomiting. Outcome measure is reported as percentage of patients with nausea and vomiting requiring rescue medication.|24hrs post administration of IT hydromorphone|One 25 mcg patient was missing data on this measure|||Participants|||Count of Participants
2621715|NCT01943565|Secondary|Oxygen Saturation, Need for Supplemental Oxygen|Intravenously, and to a lesser extent, intrathecally administered opioids can lead to respiratory depressions. Therefore the subjects' oxygen saturation is measured (standard clinical practice).|24hrs post administration of IT hydromorphone|One 25 mcg patient is missing data on this outcome|||percentage oxygenated haemoglobin||Standard Deviation|Mean
2621716|NCT01943565|Primary|24hr Post-partum IV Opioid Requirement|Intrathecal (IT) hydromorphone added to intrathecally administered local anesthetics for spinal anesthesia increases patient comfort by decreasing post-operative pain. This leads to a decrease in the post-operative intravenous hydromorphone requirements.|24hrs after administration of intrathecal hydromorphone|One 25 mcg patient is missing data on this outcome|||mg||Standard Deviation|Mean
2621726|NCT01943539|Primary|Reaction Time in EVO Gameplay|"EVO employs a perceptual discrimination attention/memory task as well as a continuous visuomotor driving task. Subjects were instructed to target a pre-specified stimulus, and ignore all other stimuli while navigating a road-like course. Reaction time was measured as the time between the initial presentation of the pre-specified target and when the subject tapped the tablet screen. Longer reaction times indicated a larger deficit in multitasking."|28 days|All subjects completing 4 weeks of at-home play and returning to the clinic on DAY 28.|||Reaction time (ms)||Standard Deviation|Mean
2621806|NCT01942707|Secondary|Volume of Seroma Assessed by Ultrasound of the Abdominal Wall.|An ultrasound of the abdominal wall will be realized to check the volume of any residual seroma.|Done after 20 days of surgery||||ml||Standard Deviation|Mean
2621717|NCT01943552|Secondary|Main Post-operative Pulmonary Complications (Including Pneumonia, Atelectasis and Acute Respiratory Failure) Within Three Weeks After the Surgery|Number of patients with at least one main post-operative pulmonary complications (including pneumonia, atelectasis and acute respiratory failure) within three weeks after the surgery. Post-operative pneumonia was defined by the presence of the following criteria: persistent lung infiltrate on chest X-ray or chest computerized tomography (CT)-scan, white blood cell count >10,000 /mm3 and fever. Post-operative atelectasis was diagnosed by presence of atelectasis affecting one lobe or several lobes in chest X-ray test or chest CT-scan. Post-operative acute respiratory failure was defined by the presence of: PaO2 < 60 mmHg and/or PaCO2 > 50 mmHg while breathing air or other evidences which were considered as respiratory failure by investigators.|From surgery to 3 weeks post surgery, up to 21 days|Surgery complete set (SCS): All patients who completed surgery.|||Participants|||Number
2621718|NCT01943552|Secondary|Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Arterial Carbon Dioxide Pressure (PaCO2) Value|Change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3): arterial carbon dioxide pressure (PaCO2) value|Baseline and Treatment day 3|Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed)|||mmHg||Standard Error|Least Squares Mean
2621719|NCT01943552|Secondary|Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Oxygen Saturation|Change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3): Oxygen saturation|Baseline and Treatment day 3|Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed)|||Percentage of Oxygen||Standard Error|Least Squares Mean
2621720|NCT01943552|Secondary|Change of Blood Gas Analyses From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery: Arterial Oxygen Pressure (PaO2) Value|Change of blood gas analyses from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3): arterial oxygen pressure (PaO2) value|Baseline and Treatment day 3|Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed)|||mmHg||Standard Error|Least Squares Mean
2621721|NCT01943552|Secondary|Change of Forced Vital Capacity (FVC) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery|Change of forced vital capacity (FVC) from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3). Measurements of FVC were performed using calibrated electronic spirometers. Equipment and techniques should conform to American Thoracic Society (ATS) criteria (P05-12782). At Visit 1, pulmonary function testing (PFT) was performed at baseline and repeated 30 minutes following inhalation of 4 puffs of salbutamol hydrofluoroalkanes metered-dose inhaler (HFA MDI). At Visit 3, pulmonary function testing was performed 60 minutes following the inhalation of investigational drug. Spirometry was conducted with the patient in a seated position having abstained from medications. The best of three efforts was defined as the highest FVC each obtained on any of three efforts meeting the ATS criteria and it was selected regardless of whether they came from different spirometric manoeuvres or the same manoeuvre.|Baseline and Treatment day 3|Full analysis set (FAS). (Only patients with observed cases (OC) values were analysed)|||ml||Standard Error|Least Squares Mean
2621722|NCT01943552|Primary|Change of Forced Expiratory Volume in 1 Second (FEV1) From Pre-bronchodilator at Baseline to Post-nebulization One Day Before the Surgery|Change of forced expiratory volume in 1 second (FEV1) from pre-bronchodilator at baseline to post-nebulization one day before the surgery (Treatment day 3). Measurements of FEV1 were performed using calibrated electronic spirometers. Equipment and techniques should conform to American Thoracic Society (ATS) criteria (P05-12782). At screening visit, pulmonary function testing (PFT) was performed at baseline and repeated 30 minutes following inhalation of 4 puffs of salbutamol hydrofluoroalkanes metered-dose inhaler (HFA MDI). At treatment day 3, pulmonary function testing was performed 60 minutes following the inhalation of investigational drug. Spirometry was conducted with the patient in a seated position having abstained from medications. The best of three efforts was defined as the highest FEV1 each obtained on any of three efforts meeting the ATS criteria and it was selected regardless of whether they came from different spirometric manoeuvres or the same manoeuvre.|Baseline and Treatment day 3|Full analysis set (FAS): All patients in the treated set who had observed analysable data in at least one efficacy endpoint. (Only patients with observed cases (OC) values were analysed)|||ml||Standard Error|Least Squares Mean
2621723|NCT01943539|Other Pre-specified|Mean of Differences in TOVA Attention Performance Index (API) at Baseline (Day 0) and at Day 28|"TOVA API is a comparison of the subject's scores based on selected measures that persons with an independent diagnosis of ADHD frequently demonstrated. The API is calculated from variability, response time, and D' (D Prime) using the following formula:~API = Response Time Z score (Half 1) + D' Z score (Half 2) + Variability Z score (Total) + 1.80~where Response Time is the average time it takes to respond correctly to a target, d' (D Prime) score is a response discriminability score reflecting the ratio of hits to false alarms, and Variability is a measure of consistency of speed of responding based on the standard deviation of the mean correct response times. API tells how similar the score is to the ADHD profile. A score of less than -1.8 indicates that the subject had similar performance to a normative ADHD population. A lower score indicates a more severe ADHD profile.~The calculation for difference in TOVA API was API at Baseline (Day 0) minus API at Day 28."|Day 0 and Day 28|All subjects completing 4 weeks of at-home play and returning to the clinic on DAY 28.|||Cumulative z-score||95% Confidence Interval|Mean
2621724|NCT01943539|Secondary|Time Spent Completing the Intervention|Time spent on completing the intervention is based on the prescribed therapy of 800 total minutes, or 13.3 hours, over the course of 28 days (7 sessions of EVO per day for 5 days per week for 4 weeks with each session lasting approximately 5.7 minutes long).|28 days|All subjects completing 4 weeks of at-home play and returning to the clinic on DAY 28.|||Hours||Standard Deviation|Mean
2621725|NCT01943539|Primary|Number of Participants With Non-Treatment Related Adverse Events|Another objective of this study is to evaluate the safety of EVO game play based on treatment-emergent adverse events (TEAEs) that may occur during this 28-day period of time.|Day 0 through Day 28 of the study|All subjects completing 4 weeks of at-home play and returning to the clinic on DAY 28.|||Participants|||Count of Participants
2622234|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2)||Visit 3 (Month 2)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||participants|||Number
2621728|NCT01943474|Secondary|Patient Satisfaction Comfort Comparison|Patient satisfaction with comfort of IV insertion compared to most recent previous IV insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.|Immediately after catheter insertion, within the first 3-15 minutes of insertion procedure.||||units on a scale||Standard Deviation|Mean
2621729|NCT01943474|Secondary|Adverse Events|Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time (anticipated to be similar in both groups). This period will generally include up to 7 days of total IV dwell time.|During and post IV catheter placement until study exit (maximum of 6 months).||||percentage of participants|||Number
2621730|NCT01943474|Secondary|Clinician Satisfaction|Will measure clinician satisfaction of the AccuCath IV device via a 5 point Likert scale survey based on overall catheter performance during experience and use. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.|At completion of study after all patients have been enrolled (approximately 6 months from study initiation)||||units on a scale||Full Range|Mean
2621731|NCT01943474|Secondary|Patient Satisfaction At Insertion|Will survey patients regarding satisfaction with catheter insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.|At catheter insertion, initial 3-15 minutes after insertion procedure completed.||||units on a scale||Standard Deviation|Mean
2621732|NCT01943474|Secondary|Catheter Dwell Time|Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) ~ up to 7 days.|Study Exit/At catheter removal (~ up to 7 days)||||hours||Standard Deviation|Mean
2621733|NCT01943474|Secondary|Complications of Peripheral IV Therapy|Will measure the rate of observed (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (~ up to 7 days).|From during to post IV catheter placement up to study exit (~ up to 7 days)||||percentage of participants||95% Confidence Interval|Number
2621734|NCT01943474|Secondary|Completion of IV Therapy|Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (~ up to 7 days).|Study exit/At catheter removal (~ up to 7 days)||||percentage of participants||95% Confidence Interval|Number
2621735|NCT01943474|Primary|First Attempt Success Rate With Peripheral IV Catheter Placement|The primary outcomes measure is to observe first attempt success rate in patients requiring peripheral IV access by documenting the number of catheter attempts (each new catheter) required to complete successful peripheral IV placement.|At catheter placement, an expected average of 10 minutes||||percentage of participants||95% Confidence Interval|Number
2621736|NCT01943435|Other Pre-specified|Sense Wear Armband|Our secondary aim was to measure the change in physical activity between baseline and 8 weeks using the Sense Wear armband (SWA). The outcome measure was the average number of minutes spent daily performing physical activities >1.5 metabolic equivalents (METs).The SWA is a small device that collects information from multiple sensors: a triaxial accelerometer, heat flux, skin temperature, and galvanic signal. The information is integrated and processed by software using proprietary algorithms utilizing subjects' demographic characteristics (gender, age, height, and weight) to provide minute-by-minute estimates of physical activity. The SWA has shown good reliability and validity. The research participants in our study will wear the SWA for a week before and after they complete the treatment interventions.|Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).|Analysis performed on all randomized participants and linear mixed models were used to account for missing data.|||minutes per day||Standard Deviation|Mean
2621737|NCT01943435|Secondary|Self Paced Walking Test (SPWT)|Our primary aim also included a performance-based outcome measure, which was the distance walked during the SPWT. The analysis was a comparison of between-group changes in SPWT between baseline and 8 weeks. The Self-Paced Walking Test (SPWT) is a validated objective measure of a patient's walking capacity, which is performed on a level walking surface. The patient is instructed to walk at their own pace and to stop when the symptoms are troublesome enough that s/he needs to sit down to rest. The total time and total distance walked are measured by the research assistant. Our unit of measure was the total distance walked, expressed in meters.|Primary end-point was 8 weeks ( 2 weeks after 6 week intervention is completed).|Analysis performed on all randomized participants and linear mixed models were used to account for missing data.|||meters||Standard Deviation|Mean
2621738|NCT01943435|Primary|Swiss Spinal Stenosis (SSS) Questionnaire Score|Our primary aim included a primary outcome measure of self-reported pain/function, which was the change in SSS total score between baseline and 8 weeks. The Swiss Spinal Stenosis Questionnaire (SSS) is a validated 12-item condition-specific instrument for patients with lumbar spinal stenosis. It provides a patient self-report measure of pain and physical function. Higher scores represent worse symptoms and less physical function. The 12-item SSS total score range is 12-55. For our analysis, we compared the change in the 12-item Total score from baseline to 8 weeks.|Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).|Analysis performed on all randomized participants and linear mixed models were used to account for missing data.|||units on a scale||Standard Deviation|Mean
2621739|NCT01943344|Other Pre-specified|Performance|Assessed by technical success rate for the VIVASURE CLOSURE DEVICE™ (Tech Success: haemostasis by investigational device, not leading to alternative treatment other than manual compression or adjunctive endovascular ballooning)|up to 3 month of implantation|All subjects entered into study that received the Vivasure Closure Device or had intension to treat with the Vivasure Closure Device.|||percentage of successful deployments|||Number
2621740|NCT01943344|Secondary|Minor Vascular Complications Directly Related to Device|Incidence of minor complications directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation, as defined by VARC-2.|up to 3 months from implantation|Two subjects died prior to 3-month follow-up, not related to the study device, hence, were not included in analysis. A third subject died prior to study completion (12 month follow-up), not related to the study device.|||percentage of Participants|||Number
2621741|NCT01943344|Primary|Major Vascular Complications Directly Related to Device|Major complication rates directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation, (as defined by VARC-2).|up to 3 Months of implantation|Two subjects died prior to 3-month follow-up, not related to the study device, hence, were not included in analysis. A third subject died prior to study completion (12 month follow-up), not related to the study device.|||percentage of participants|||Number
2621742|NCT01943292|Secondary|Evaluate the Efficacy (Response Rate and Progression-free Survival) of Subjects Treated With Defactinib (VS-6063).|Response rate and progression-free survival, as determined by Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1|Every 8 weeks up to end of treatment, an expected average of 12 weeks|||||||
2621743|NCT01943292|Secondary|Assess the Pharmacokinetics, Metabolism and Elimination of Defactinib (VS-6063) in Plasma and Urine.|PK parameters, including but not limited to plasma concentration, AUC (Area Under Curve) 0-t, Cmax, Tmax, and T1/2. Total 24-hour urine output will be collected in conjunction with PK sampling to assess the elimination of defactinib (VS-6063) and its potential metabolites.|Time points at Day 1 and Day 15 in Cycle 1|||||||
2621744|NCT01943292|Secondary|Define the Maximum Tolerated Dose (MTD), if Achieved, and Establish the Recommended Phase 2 Dose (RP2D) of Defactinib (VS-6063) in Japanese Subjects.|The RP2D will be determined based on the MTD of defactinib (VS-6063) as determined by number of participants with dose limiting toxicities (DLTs) related to defactinib.|From start of treatment to end of cycle 1 (21 day cycles)||||mg|||Number
2621745|NCT01943292|Primary|Assess the Safety and Tolerability of Defactinib (VS-6063) in Japanese Subjects With Non-hematologic Malignancies|"A composite by dose level to include incidence of AEs, SAEs, dose interruptions and dose reductions as a measure of safety and tolerability. Abnormal Clinical significant laboratory results, ECG measurements, vital signs measurement, physical examination findings, and ECOG performance status were captured as adverse events.~The severity of AEs were evaluated according to CTCAE (Common Toxicity Criteria for Adverse Effects) 4.03"|From start of treatment to end of treatment, an expected average of 12 weeks||||participants|||Number
2621746|NCT01943227|Primary|Airway Enthalpy|This is a single site, prospective, non-blinded, non-randomized, non-interventional study designed to evaluate the effect of changes in alveolar minute ventilation on the measurement of respiratory heat loss (enthalpy) in Joules per minute.|12 months||||Joules/Minute||Standard Deviation|Mean
2621747|NCT01943110|Secondary|Proportion of Injections With Safety Events|The proportion of injections with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection.|Within 30 minutes and within 48 hours of injection||||percentage of injections|Participants||Number
2621748|NCT01943110|Primary|Proportion of Injections Delivered to the Intradermal Layer of the Skin|The proportion of saline injections resulting in delivery to the intradermal layer of the skin will be assessed by measurement of intradermal wheals with diameters ≥ 5mm and the volume of liquid injected.|1 day||||Injections|Participants||Number
2621749|NCT01942785|Primary|CGI-I Score at Week 6 Patients With a Pre-defined Baseline BIS-11 Total Score|The subgroups denoted BIS-11_HIGH had a BIS-11 total score at Baseline ≥median at baseline and the subgroups denoted BIS-11_LOW had a BIS-11 total score <median at baseline. The Clinical Global Impression - global improvement CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6|full-analysis set (FAS)|||units on a scale||Standard Error|Mean
2621750|NCT01942785|Primary|Change From Baseline to Week 6 in CGI-S Score in Patients With a Pre-defined Baseline BIS-11 Total Score|The subgroups denoted BIS-11_HIGH had a BIS-11 total score at Baseline ≥median at baseline and the subgroups denoted BIS-11_LOW had a BIS-11 total score <median at baseline. The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|full-analysis set (FAS)|||units on a scale||Standard Error|Mean
2621751|NCT01942785|Primary|Change From Baseline to Week 6 in MADRS Total Score in Patients With a Pre-defined Baseline BIS-11 Total Score|The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. Subgroup analyses were performed for the change from Baseline to Week 6 in MADRS total score based on the patients' BIS-11 total score at Baseline. The subgroups denoted BIS-11_HIGH had a BIS-11 total score at Baseline ≥median at baseline and the subgroups denoted BIS-11_LOW had a BIS-11 total score <median at baseline. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|full-analysis set (FAS)|||units on a scale||Standard Error|Mean
2621752|NCT01942785|Primary|Change From Week 6 to Week 10 in CGI-S Score|The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS)|||units on a scale||Standard Error|Mean
2621753|NCT01942785|Primary|Change From Week 6 to Week 10 in KSQ Depression Subscore|The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ depression subscale score ranges from 0 to 23, with higher values indicating worse outcome . As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS)|||units on a scale||Standard Error|Mean
2621754|NCT01942785|Primary|Change From Week 6 to Week 10 in KSQ Anger-hostility Subscore|The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ anger-hostility subscale score ranges from 0 to 23 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS)|||units on a scale||Standard Error|Mean
2621755|NCT01942785|Primary|Change From Week 6 to Week 10 in BIS-11 Total Score|The Barratt Impulsiveness Scale, Version 11 (BIS-11) is a patient-rated scale designed to assess impulsive personality traits. The BIS-11 consists of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provide information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranges from 30 to 120 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS). Only patients who have observed data at Week 10 were included in the ANCOVA analysis.|||units on a scale||Standard Error|Mean
2621756|NCT01942785|Primary|Change From Week 6 to Week 10 in Delay Discounting - MCQ Scores|"The Monetary Choice Questionnaire (MCQ) is a patient-completed questionnaire designed to measure delay discounting, an index of impulsive behaviour. The MCQ consists of 27 choices between immediate and delayed rewards. The patients choose repeatedly between two hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, ''Would you prefer $27 today or $50 in 21 days?). The answers provide an estimate of the patient's discounting rate. The discounting rate parameter takes values between 0 and 1 and higher discounting rates indicate impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes."|Week 6 and Week 10|Completer's-analysis set (CAS). Only patients who have observed data at Week 10 were included in the ANCOVA analysis; the number of participants analysed is therefore smaller than the defined CAS.|||log-transformed units on a scale||Standard Error|Mean
2621757|NCT01942785|Primary|Change From Week 6 to Week 10 in SIS Item 1 Score|The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS item 1 assess how much the patient has suffered from irritability in the past week, using verbal descriptors (not at all, mildly, moderately, markedly, and extremely) as well as numerical scores from 0 (not at all) to 10 (extremely) that provide more precise levels of the verbal descriptors. The SIS item 1 ranged from 0 to 10 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS). Only patients who have observed data at Week 10 were included in the ANCOVA analysis; the number of participants analysed is therefore smaller than the defined CAS.|||units on a scale||Standard Error|Mean
2621758|NCT01942785|Primary|Change From Week 6 to Week 10 in SIS Total Score|The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS consists of 7 subscales assessing irritability, frustration, edginess/impatience/overreaction, moodiness, anger with self, anger with others, and temper. The patient rates the extent to which they have suffered from these symptoms. Each subscale has verbal descriptors (not at all, mildly, moderately, markedly, and extremely) as well as numerical scores from 0 (not at all) to 10 (extremely) that provide more precise levels of the verbal descriptors. One additional question assesses number of days impaired by irritability over the period. The subscales are summarised to give the total score which ranges from 0 to 70, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6 and Week 10|Completer's-analysis set (CAS)|||units on a scale||Standard Error|Mean
2621759|NCT01942785|Primary|Change From Baseline to Week 6 in Delay Discounting - EDT DRT Score|DRT consists of 60 choices between an immediate reward or a higher delayed reward. The number of impulsive choices will be a continuous variable estimated from how many immediate choices based on 60 possible. The number ranges between 0 and 60, with a higher value indicating more impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|full-analysis set (FAS). Only patients who have observed data at Week 6 were included in the ANCOVA analysis; the number of participants analysed is therefore smaller than the defined FAS.|||units on a scale||Standard Error|Mean
2621760|NCT01942785|Primary|Change From Baseline to Week 6 in Delay Discounting - Log-transformed EDT DPDT Scores|DPDT consists of approximately 110 choices between an immediate reward or a higher delayed reward, and between an immediate reward or a higher reward that only comes with a certain probability. The tasks are scored independently of each other and do not yield a total score. There will be two derived variables from this task; a delayed discounting rate and a probability discounting rate. The delay discounting value takes values from 0 and up, a higher delay discounting value indicates greater impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|full-analysis set (FAS). Only patients who have observed data at Week 6 were included in the ANCOVA analysis; the number of participants analysed is therefore smaller than the defined FAS.|||log transformed units on a scale||Standard Error|Mean
2621761|NCT01942785|Primary|Change From Baseline to Week 6 in KSQ Total Score|"The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ consists of 92 items which form the basis for the four subscales: depression, anxiety, anger-hostility, and somatic; of which 68 items indicate symptoms (symptom subscales) and 24 items are antonyms of some of the symptoms and indicate well-being (well-being subscales). A yes or true response on the symptom subscales scores 1, and a no or false on the well-being subscales scores 1. The maximum score for each symptom subscale is 17, and the maximum score for each well-being subscale is 6. The score of each subscale ranges from 0 to 23 (the sum of the symptom subscale and the well-being subscale). A higher score indicates more distress. The total score ranges from 0 to 92. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes."|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
2622235|NCT01940484|Primary|Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1)||Visit 2 (Month 1)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||participants|||Number
2621762|NCT01942785|Primary|CGI-I Score at Week 6|The Clinical Global Impression - global improvement CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 6|Full-analysis set (FAS), this endpoint presents descriptive statistics for CGI-I based on patients who have CGI-I score observed at Week 6; the number of participants analysed is therefore smaller than the defined FAS.|||units on a scale||Standard Error|Mean
2621763|NCT01942785|Primary|Change From Baseline to Week 6 in CGI-S Score|The Clinical Global Impression severity of illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
2621764|NCT01942785|Primary|Change From Baseline to Week 6 in CPFQ Total Score|The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) is a patient-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The CPFQ consists of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranges from 7 to 42, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
2621765|NCT01942785|Primary|Change From Baseline to Week 6 in MADRS Total Score|The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
2621766|NCT01942785|Primary|Change From Baseline to Week 6 in KSQ Depression Subscore|The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ depression subscale score ranges from 0 to 23, with higher values indicating worse outcome . As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
2621767|NCT01942785|Primary|Change From Baseline to Week 6 in IDS-C30 Total Score|The 30-item Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C30) is a clinician-rated scale designed to assess the severity of depressive symptoms. The IDS-C30 consists of 30 items assessing the symptoms of depression, as well as commonly associated symptoms (for example, anxiety, irritability), and topics relevant to melancholic or atypical features; the patient rates only one of the 2 items assessing appetite (decreased or increased), and only one of the 2 items assessing weight (loss or gain). Each of the items is rated on a 4-point anchored scale from 0 (least severe) to 3 (most severe). The total score is the sum of the 28 scored items, and ranges from 0 to 84, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
2621768|NCT01942785|Primary|Shift From Baseline to Week 6 in Anger Attacks (AAQ)|The Anger Attacks Questionnaire (AAQ) is a patient-rated scale designed to assess the presence of anger attacks over a period of time. The AAQ consists of 7 items. Patients are classified as having anger attacks when exhibiting the following 4 criteria: 1) irritability, 2) overreaction to minor annoyances, 3) occurrence of anger attacks (at least one of which occurred within the period), and 4) experienced 4 or more specific symptoms during at least one of the attacks. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS) and OC. Only patients who have both baseline and Week 6 data observed were included; the number of participants analysed is therefore smaller than the defined FAS.|||participants|||Number
2621769|NCT01942785|Primary|Change From Baseline to Week 6 in KSQ Anger-hostility Subscore|The Kellner Symptom Questionnaire (KSQ) is a patient-rated scale designed to assess distress using symptoms of depression, anxiety, anger-hostility, and somatization. The KSQ anger-hostility subscale score ranges from 0 to 23 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
2621770|NCT01942785|Primary|Change From Baseline to Week 6 in BIS-11 Total Score|The Barratt Impulsiveness Scale, Version 11 (BIS-11) is a patient-rated scale designed to assess impulsive personality traits. The BIS-11 consists of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The total score ranges from 30 to 120 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
2621771|NCT01942785|Primary|Change From Baseline to Week 6 in Delay Discounting - Log-transformed MCQ Scores|"The Monetary Choice Questionnaire (MCQ) is a patient-completed questionnaire designed to measure delay discounting, an index of impulsive behaviour. The MCQ consists of 27 choices between immediate and delayed rewards. The patients choose repeatedly between two hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, ''Would you prefer $27 today or $50 in 21 days?). The answers provide an estimate of the patient's discounting rate. The discounting rate parameter takes values between 0 and 1 and higher discounting rates indicate impulsivity. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes."|Baseline and Week 6|Full-analysis set (FAS)|||log-transformed units on a scale||Standard Error|Mean
2622254|NCT01940120|Secondary|Number of Participants With Mitral Valve Replacement|Defined as how often patients receiving surgery required replacement of the mitral valve.|12 months||||Participants|||Count of Participants
2621772|NCT01942785|Primary|Change From Baseline to Week 6 in IDS-C30 Item 6 Score|The 30-item Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C30) is a clinician-rated scale designed to assess the severity of depressive symptoms. The IDS-C30 item 6 measures mood (irritable) and is rated on a 4-point anchored scale from 0 (least severe) to 3 (most severe) with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
2621773|NCT01942785|Primary|Change From Baseline to Week 6 in SIS Item 1 Score|The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS item 1 assess how much the patient has suffered from irritability in the past week. The SIS item 1 ranged from 0 to 10 with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
2621774|NCT01942785|Primary|Change From Baseline to Week 6 in SIS Total Score|The Sheehan Irritability Scale (SIS) is a patient-rated scale designed to measure irritability. The SIS consists of 7 subscales assessing irritability, frustration, edginess/impatience/overreaction, moodiness, anger with self, anger with others, and temper. The subscales are summarised to give the total score which ranges from 0 to 70, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
2621775|NCT01942733|Primary|CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) assesses the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
2621776|NCT01942733|Primary|Change From Baseline to Week 8 in BRIAN Total Score|The Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) is a clinician-rated scale designed to assess biological rhythms. The BRIAN consists of 18 items divided in 4 subscales: sleep (5 items), activity (5 items), social (4 items), and eating pattern (4 items). Each item is rated on a scale from 1 (no difficulties) to 4 (serious difficulties). The total score of the 18 items ranges from 18 to 72, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
2621777|NCT01942733|Primary|Changes From Baseline to Week 8 on Number of Awakenings (NAW) as Assessed by Actigraphy (ACT)|The key ACT parameters assessed were the total sleep time (ACT TST), sleep efficiency (ACT SE), sleep onset latency (ACT SOL), wake-time after sleep onset (ACT WASO), and the number of awakenings (ACT NAW). The results for ACT TST, ACT SE, ACT WASO, and ACT NAW are presented separately from ACT SOL as the number of patients available for analysis was different. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||number of events||Standard Error|Mean
2621778|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Efficiency (SE) as Assessed by Actigraphy (ACT)|The key ACT parameters assessed were the total sleep time (ACT TST), sleep efficiency (ACT SE), sleep onset latency (ACT SOL), wake-time after sleep onset (ACT WASO), and the number of awakenings (ACT NAW). The results for ACT TST, ACT SE, ACT WASO, and ACT NAW are presented separately from ACT SOL as the number of patients available for analysis was different. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||percentage of time||Standard Error|Mean
2621779|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by Actigraphy (ACT) Parameters|The key ACT parameters assessed were the total sleep time (ACT TST), wake-time after sleep onset (ACT WASO), sleep onset latency (ACT SOL), sleep efficiency (ACT SE), and the number of awakenings (ACT NAW). The results for ACT TST, ACT WASO, and ACT SOL are presented separately from ACT SE, and from ACT NAW, due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||minutes||Standard Error|Mean
2621780|NCT01942733|Primary|Percentage of MADRS Remitters at Week 8|The Montgomery Aasberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptoms) to 6 (severe symptoms). Definitions of severity are provided at two-point intervals. The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. Remission was defined as a MADRS total score ≤10 and a ≥50% decrease in MADRS total score from baseline. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||percentage of patients|||Number
2621807|NCT01942707|Secondary|Number of Days Required for Drain Withdrawal.|Number of days required for drain withdrawal. The measure of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours.|Number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days||||days||Standard Deviation|Mean
2621781|NCT01942733|Primary|Percentage of MADRS Responders at Week 8|The Montgomery Aasberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptoms) to 6 (severe symptoms). Definitions of severity are provided at two-point intervals. The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. Response was defined as a ≥50% decrease in MADRS total score from baseline. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||percentage of patients|||Number
2621782|NCT01942733|Primary|Change From Baseline to Week 8 in CGI-S Score|The Clinical Global Impression - Severity of Illness (CGI-S) scale assesses the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients), with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
2621783|NCT01942733|Primary|Change From Baseline to Week 8 in MADRS Total Score|The Montgomery Aasberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Items in the scale assess apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Symptoms are rated on a 7-point scale from 0 (no symptoms) to 6 (severe symptoms). Definitions of severity are provided at two-point intervals. The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
2621784|NCT01942733|Primary|Changes From Baseline to Week 8 in Circadian and Biological Rhythm|The parameters used to assess circadian and biological rhythm were the time to peak cortisol concentration, time to dim-light melatonin onset (DLMO) and phase angle. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||minutes||Standard Error|Mean
2621785|NCT01942733|Primary|Change From Baseline to Week 8 in CPFQ Total Score|The Cognitive and Physical Functioning Questionnaire (CPFQ) is a patient-rated scale designed to assess cognitive and executive dysfunction including symptoms of fatigue in mood and anxiety disorders. The CPFQ consists of 7 items, each rated on a scale from 1 (greater than normal functioning) to 6 (poorer than normal functioning). The total score of the 7 items ranges from 7 to 42, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
2621786|NCT01942733|Primary|Change From Baseline to Week 8 on BL-VAS-s Scores (Noon)|The Bond-Lader Visual Analogue Scale - Sedation (BL-VAS-s) is a patient-rated scale designed to assess the current level of sedation. The BL-VAS-s was assessed for the evening (19:00 to 23:59 hours), morning (00:00 to 08:59 hours) and at noon (11:00 to 13:59 hours). The BL-VAS-s is a single item scale rated on a 100mm visual analogue scale. The score is measured from the left to a mark made on the line by the patient and ranges from 0 (alert) to 100 (drowsy). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
2621787|NCT01942733|Primary|Change From Baseline to Week 8 on BL-VAS-s (Morning) Score|The Bond-Lader Visual Analogue Scale - Sedation (BL-VAS-s) is a patient-rated scale designed to assess the current level of sedation. The BL-VAS-s was assessed for the evening (19:00 to 23:59 hours), morning (00:00 to 08:59 hours) and at noon (11:00 to 13:59 hours). The BL-VAS-s is a single item scale rated on a 100mm visual analogue scale. The score is measured from the left to a mark made on the line by the patient and ranges from 0 (alert) to 100 (drowsy). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
2621788|NCT01942733|Primary|Change From Baseline to Week 8 on BL-VAS-s (Evening) Score|The Bond-Lader Visual Analogue Scale - Sedation (BL-VAS-s) is a patient-rated scale designed to assess the current level of sedation. The BL-VAS-s was assessed for the evening (19:00 to 23:59 hours), morning (00:00 to 08:59 hours) and at noon (11:00 to 13:59 hours). The BL-VAS-s is a single item scale rated on a 100mm visual analogue scale. The score is measured from the left to a mark made on the line by the patient and ranges from 0 (alert) to 100 (drowsy). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
2622816|NCT01936363|Secondary|Molecular Alterations in MAPK and/or PI3K Signaling Pathway Components/Modulators in Tumor Tissue and Blood||Screening visit (day -28 to 1)|As per changed in planned analysis the outcome measure related to pharmacodynamics parameters was not assessed.||||||
2621789|NCT01942733|Primary|Changes From Baseline to Week 8 in Number of Lapses as Assessed Using a PVT Device|The psychomotor vigilance task (PVT) measures sustained or vigilant attention by recording response time (milliseconds) to a visual/or auditory stimulus that appears at random inter-stimulus intervals (range: from 2 to 10 seconds). The patient was instructed to monitor a red rectangular box on the computer screen and to press a response button as soon as a yellow stimulus counter appeared on the screen. The parameters assessed using a PVT device were response speed and number of lapses. The results for response speed is presented separately from the number of lapses due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||number||Standard Error|Mean
2621790|NCT01942733|Primary|Changes From Baseline to Week 8 in Response Speed as Assessed Using a PVT Device|The psychomotor vigilance task (PVT) measures sustained or vigilant attention by recording response time (milliseconds) to a visual/or auditory stimulus that appears at random inter-stimulus intervals (range: from 2 to 10 seconds). The patient was instructed to monitor a red rectangular box on the computer screen and to press a response button as soon as a yellow stimulus counter appeared on the screen. The parameters assessed using a PVT device were response speed and number of lapses. The results for response speed is presented separately from the number of lapses due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||speed (per second)||Standard Error|Mean
2621791|NCT01942733|Primary|Change From Baseline to Week 8 on ESS Total Score|The Epworth Sleepiness Scale (ESS) is a is a patient-rated scale designed to measure daytime sleepiness. The ESS consists of 8 items describing different situations/activities and the patients rate the chance of them dozing off or falling asleep when they are in these situations. Each item is rated on a 4-point scale from 0 (would never dose) to 3 (high change of dozing). The total score of the 8 items ranges from 0 to 24, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
2621792|NCT01942733|Primary|Change From Baseline to Week 8 in ISI Total Score|The Insomnia Severity Index (ISI) is a patient-rated scale desgined to measure the patient's perception of his/her insomnia. The ISI comprises 7 items: difficulty falling asleep, difficulty staying asleep, problems waking up early in the morning, satisfaction with current sleep pattern, interference with daily functioning, how much others notice the sleep problem impairs quality of life, and distress caused by the sleep problem. Each of the 7 items is rated on a 5-point scale from 0 (best situation) to 4 (worst situation). The total score of the 7 items ranges from 0 to 28, with higher values indicating worse outcome. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||units on a scale||Standard Error|Mean
2621793|NCT01942733|Primary|Changes From Baseline to Week 8 in Sleep Architecture as Assessed With Polysomnography (Continued)|The key sleep architecture parameters assessed with polysomnography were the percentage of time and duration spent in Stages N1 (non-rapid eye movement [non-REM]), N2 (non-REM), N3 (non-REM), and REM, respectively, as well as the duration of latency to REM sleep. The results for the percentage of time spent at each stage is presented separately from the duration due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||minutes||Standard Error|Mean
2621794|NCT01942733|Primary|Changes From Baseline to Week 8 in Sleep Architecture as Assessed With Polysomnography|The key sleep architecture parameters assessed with polysomnography were the percentage of time and duration spent in Stages N1 (non-rapid eye movement [non-REM]), N2 (non-REM), N3 (non-REM), and REM, respectively, as well as the duration of latency to REM sleep. The results for the percentage of time spent at each stage is presented separately from the duration due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||percentage of total sleep duration||Standard Error|Mean
2621795|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by the Consensus Sleep Diary for Morning (CSD-M) Number of Awakenings (NAW)|The key CSD-M parameters assessed were the sleep efficiency (CSD-M SE), total sleep time (CSD-M TST), sleep onset latency (CSD-M SOL), wake-time after sleep onset (CSD-M WASO), and number of awakenings (CSD-M NAW). As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||number||Standard Error|Mean
2621796|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by the Consensus Sleep Diary for Morning (CSD-M)|The key CSD-M parameters assessed were the sleep efficiency (CSD-M SE), total sleep time (CSD-M TST), sleep onset latency (CSD-M SOL), wake-time after sleep onset (CSD-M WASO), and number of awakenings (CSD-M NAW). The results for CSD-M SE are presented separately from CSD-M TST, CSD-M SOL, and CSD-M WASO, and from CSD-M NAW due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||minutes (min)||Standard Error|Mean
2621797|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by the Consensus Sleep Diary for Morning (CSD-M) Sleep Efficiency (SE)|The key CSD-M parameters assessed were the sleep efficiency (CSD-M SE), total sleep time (CSD-M TST), sleep onset latency (CSD-M SOL), wake-time after sleep onset (CSD-M WASO), and number of awakenings (CSD-M NAW). The results for CSD-M SE are presented separately from CSD-M TST, CSD-M SOL, and CSD-M WASO, and from CSD-M NAW due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||percentage of time||Standard Error|Mean
2621798|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Sleep Efficiency (PSG SE)|The key PSG parameters assessed were the latency to persistent sleep (PSG LPS), sleep onset latency (PSG SOL), wake-time after sleep onset (PSG WASO), total sleep time (PSG TST), number of awakenings (PSG NAW), and sleep efficiency (PSG SE). The results for PSG LPS, PSG SOL, PSG WASO, and PSG TST are presented separately from the PSG NAW, and from the PSG SE due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||percentage (%)||Standard Error|Mean
2621799|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Number of Awakenings (PSG NAW)|The key PSG parameters assessed were the latency to persistent sleep (PSG LPS), sleep onset latency (PSG SOL), wake-time after sleep onset (PSG WASO), total sleep time (PSG TST), number of awakenings (PSG NAW), and sleep efficiency (PSG SE). The results for PSG LPS, PSG SOL, PSG WASO, and PSG TST are presented separately from the PSG NAW, and from the PSG SE due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||number of events||Standard Error|Mean
2621800|NCT01942733|Primary|Changes From Baseline to Week 8 on Sleep Quality as Assessed by Polysomnographic Recorded (PSG) Parameters|The key PSG parameters assessed were the latency to persistent sleep (PSG LPS), sleep onset latency (PSG SOL), wake-time after sleep onset (PSG WASO), total sleep time (PSG TST), number of awakenings (PSG NAW), and sleep efficiency (PSG SE). The results for PSG LPS, PSG SOL, PSG WASO, and PSG TST are presented separately from the PSG NAW, and from the PSG SE due to the different units of measurement involved. As this was an open-label exploratory study, all outcomes should be considered as exploratory outcomes.|Baseline and Week 8|The full-analysis set (FAS) comprised all patients treated, who had a valid baseline assessment and at least one valid post-baseline efficacy assessment. The analysis was performed using observed cases (OC) data.|||minutes (min)||Standard Error|Mean
2621801|NCT01942720|Secondary|Adverse Events (AE)|To assess safety related to capsule retention and other adverse events|6 months|all enrolled subjects|||AE incidents|||Number
2621802|NCT01942720|Secondary|Evaluate the Entire SB CE Scores|"Evaluate the entire SB CE Scores (Lewis & CECDEIS) change as compared to the change at TI in CE Scores (Lewis & CECDEIS).~Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no normal range Studies discuss a drop in the number as indicating healing but not a specific"|6 months change from Baseline|number of Lewis & CECDEIS TI score change is lower due to inability to identify TI. number of participants for this outcome measure includes participants with available data for total SB Lewis score change, TI Lewis score change, Total CECDEIS score change, TI Lewis score change, respectively|||units on a scale||Standard Deviation|Mean
2621803|NCT01942720|Secondary|Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum|"Evaluate the correlation between the change in SES CD score and the change in capsule scoring indexes (Lewis and CECDEIS) in the TI after 6 months SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no normal range Studies discuss a drop in the number as indicating healing but not a specific cutoff"|6 months change from Baseline|number of subjects with Colonoscopy score is lower than number of subjects analyzed due to colonoscopy video malfunction. number of participants for this outcome measure includes participants with available data for TI SES CD, TI Lewis, TI CECDEIS scores, respectively|||units on a scale||Standard Deviation|Mean
2621804|NCT01942720|Secondary|Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes|"Evaluate the correlation between SES CD score and capsule scoring indexes (Lewis and CECDEIS) in the TI (Terminal Ileum) at baseline.~SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no normal range Studies discuss a drop in the number as indicating healing but not a specific"|Baseline|number of participants for this outcome measure includes participants with available data for SES CD, TI Lewis score, TI CECDEIS score, respectively|||units on a scale||Standard Deviation|Mean
2621805|NCT01942720|Primary|Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment)|"To correlate the mucosal change in VCE mucosal score (Lewis score and CECDEIS( Capsule Endoscopy Crohn's Disease Endoscopic Index)) with change in Physician Global Assessment of CD activity 6 months after the first VCE procedure; PGA scale: 0-Normal, 1-Mild disease, 2- Moderate Disease, 3-Severe Disease Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission <135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no normal range Studies discuss a drop in the number as indicating healing but not a specific cutoff"|6 months changefrom Baseline|Correlation between changes in VCE mucosal scores (Lewis and CECDEIS) and change in PGA score of CD (Crohn's Disease) activity from baseline to follow-up at 6 months; number of participants for this outcome measure includes participants with available data for PGA, SB (small bowel) Lewis score, SB CECDEIS score, respectively|||units on a scale||Standard Deviation|Mean
2621808|NCT01942707|Primary|Total Volume of Drainage in ml.|We will measure the total volume of drainage, in ml, obtained by the drains in the abdominal region. The measure of drainage will be done at the same time (8:00 am) and by the same nurse everyday in all patients until the drain is withdrawn. The drain will be withdrawn when the drained volume is less than 30 ml in 24 hours. Total volume of drainage will be calculated as the sum of the volumes obtained daily.|number of days required for drain withdrawal (drained volume less than 30 ml in 24 hours) and no later than 10 days||||ml||Standard Deviation|Mean
2621809|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Optimal Sleep - Month 12 - (MITT)|Change from Baseline (BL) to Month 12 in MOS Optimal Sleep Score as compared with Placebo.The MOS-Sleep Self Report Questionnaire is composed of 12 items measuring 6 dimensions of sleep over the past 4 wks. Optimal sleep is based on Q2 (self-reported average hrs sleep per night in past 4 wks). Scoring method: hrs of sleep coded 0 (non-optimal) or 1 (optimal) where 1-6 hrs & 9-23 hrs = 0, 7-8 hrs = 1. Change from BL: subject sleeps 7-8 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = -1; subject sleeps 1-6 or 9-23 hrs at BL & 7-8 hrs at follow-up, change = +1; subject sleeps 1-6 or 9-23 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = 0. Mean change from BL: changes are summed to give the Net Total (equivalent to the number subjects w/ improved sleep hrs minus the number subjects w/ worsened sleep hrs), which is divided by the number of subjects to give the mean proportion of net change, where >0 = overall improvement and <0 = overall worsening in the study arm.|Baseline and Month 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||Proportion of Net Change||Standard Deviation|Mean
2621810|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Optimal Sleep - Month 6 - (MITT)|Change from Baseline (BL) to Month 6 in MOS Optimal Sleep Score as compared with Placebo.The MOS-Sleep Self Report Questionnaire is composed of 12 items measuring 6 dimensions of sleep over the past 4 wks. Optimal sleep is based on Q2 (self-reported average hrs sleep per night in past 4 wks). Scoring method: hrs of sleep coded 0 (non-optimal) or 1 (optimal) where 1-6 hrs & 9-23 hrs = 0, 7-8 hrs = 1. Change from BL: subject sleeps 7-8 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = -1; subject sleeps 1-6 or 9-23 hrs at BL & 7-8 hrs at follow-up, change = +1; subject sleeps 1-6 or 9-23 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = 0. Mean change from BL: changes are summed to give the Net Total (equivalent to the number subjects w/ improved sleep hrs minus the number subjects w/ worsened sleep hrs), which is divided by the number of subjects to give the mean proportion of net change, where >0 = overall improvement and <0 = overall worsening in the study arm.|Baseline and Month 6|All randomized subjects who took at least one dose (2 capsules) of IP.|||Proportion of Net Change||Standard Deviation|Mean
2621811|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Optimal Sleep - Week 12 - (MITT)|Change from Baseline (BL) to Wk 12 in MOS Optimal Sleep Score as compared with Placebo.The MOS-Sleep Self Report Questionnaire is composed of 12 items measuring 6 dimensions of sleep over the past 4 wks. Optimal sleep is based on Q2 (self-reported average hrs sleep per night in past 4 wks). Scoring method: hrs of sleep coded 0 (non-optimal) or 1 (optimal) where 1-6 hrs & 9-23 hrs = 0, 7-8 hrs = 1. Change from BL: subject sleeps 7-8 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = -1; subject sleeps 1-6 or 9-23 hrs at BL & 7-8 hrs at follow-up, change = +1; subject sleeps 1-6 or 9-23 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = 0. Mean change from BL: changes are summed to give the Net Total (equivalent to the number subjects w/ improved sleep hrs minus the number subjects w/ worsened sleep hrs), which is divided by the number of subjects to give the mean proportion of net change, where >0 = overall improvement and <0 = overall worsening in the study arm.|Baseline and Week 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||Proportion of Net Change||Standard Deviation|Mean
2621812|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index II - Month 12 - (MITT)|"Change from Baseline to Month 12 in MOS Sleep Problems Index II individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index II items include Q1, Q3, Q4, Q5, Q6, Q7, Q8, Q9, Q12. Scoring method: Answers to Q3, 5, 6, 7, 8, & 9 are reversed & rescaled to realign to be same direction and range 0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20, for n=Q3, 5, 6, 7, 8, and 9. Answers to Q1, 4 & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome."|Baseline and Month 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621813|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Sleep Problems Index II - Month 6 - (MITT)|"Change from Baseline to Month 6 in MOS Sleep Problems Index II individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index II items include Q1, Q3, Q4, Q5, Q6, Q7, Q8, Q9, Q12. Scoring method: Answers to Q3, 5, 6, 7, 8, & 9 are reversed & rescaled to realign to be same direction and range 0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20, for n=Q3, 5, 6, 7, 8, and 9. Answers to Q1, 4 & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome."|Baseline and Month 6|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621821|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Adequacy - Month 12 - (MITT)|Change from Baseline to Month 12 in MOS Sleep Adequacy individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Adequacy includes items Q4, Q12. Scoring method: Answers for Q4 and Q12 are reversed and rescaled to 0-100 as follows: MOS_4_new = (6-MOS_4_old) x 20; MOS_12_new = (6-MOS_12_old) x 20. Score is the average of item scores; score range = 0 to 100, where higher score means better outcome.|Baseline and Month 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621814|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index II - Week 12 - (MITT)|"Change from Baseline to Wk 12 in MOS Sleep Problems Index II individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index II items include Q1, Q3, Q4, Q5, Q6, Q7, Q8, Q9, Q12. Scoring method: Answers to Q3, 5, 6, 7, 8, & 9 are reversed & rescaled to realign to be same direction and range 0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20, for n=Q3, 5, 6, 7, 8, and 9. Answers to Q1, 4 & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome."|Baseline and Week 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621815|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index I - Month 12 - (MITT)|"Change from Baseline to Month 12 in MOS Sleep Problems Index I individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index I includes items Q4, Q5, Q7, Q8, Q9, Q12. Scoring method: Answers to Q, 5, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q4, & 12 are rescaled to 0-100 as follows: MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome."|Baseline and Month 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621816|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index I - Month 6 - (MITT)|"Change from Baseline to Month 6 in MOS Sleep Problems Index I individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index I includes items Q4, Q5, Q7, Q8, Q9, Q12. Scoring method: Answers to Q, 5, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q4, & 12 are rescaled to 0-100 as follows: MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome."|Baseline and Month 6|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621817|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index I - Week 12 - (MITT)|"Change from Baseline to Wk 12 in MOS Sleep Problems Index I individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index I includes items Q4, Q5, Q7, Q8, Q9, Q12. Scoring method: Answers to Q, 5, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q4, & 12 are rescaled to 0-100 as follows: MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome."|Baseline and Week 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621818|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Somnolence - Month 12 - (MITT)|"Change from Baseline to Month 12 in MOS Sleep Somnolence individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Somnolence items include Q6, Q9, Q11. Scoring method: Answers to Q6, Q 9 and Q11 are reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome."|Baseline and Month 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621819|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Somnolence - Month 6 - (MITT)|"Change from Baseline to Month 6 in MOS Sleep Somnolence individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Somnolence items include Q6, Q9, Q11. Scoring method: Answers to Q6, Q 9 and Q11 are reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome."|Baseline and Month 6|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621820|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Somnolence - Week 12 - (MITT)|"Change from Baseline to Wk 12 in MOS Sleep Somnolence individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Somnolence items include Q6, Q9, Q11. Scoring method: Answers to Q6, Q 9 and Q11 are reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome."|Baseline and Week 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621822|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Adequacy - Month 6 - (MITT)|Change from Baseline to Month 6 in MOS Sleep Adequacy individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Adequacy includes items Q4, Q12. Scoring method: Answers for Q4 and Q12 are reversed and rescaled to 0-100 as follows: MOS_4_new = (6-MOS_4_old) x 20; MOS_12_new = (6-MOS_12_old) x 20. Score is the average of item scores; score range = 0 to 100, where higher score means better outcome.|Baseline and Month 6|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621823|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Adequacy - Week 12 - (MITT)|Change from Baseline to Wk 12 in MOS Sleep Adequacy individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Adequacy includes items Q4, Q12. Scoring method: Answers for Q4 and Q12 are reversed and rescaled to 0-100 as follows: MOS_4_new = (6-MOS_4_old) x 20; MOS_12_new = (6-MOS_12_old) x 20. Score is the average of item scores; score range = 0 to 100, where higher score means better outcome.|Baseline and Week 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621824|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Short of Breath or Headache - Month 12 - (MITT)|"Change from Baseline to Month 12 in MOS Sleep Short of Breath or Headache(SOBHA) individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. SOBHA item is Q5. Scoring method: Answer to Q5 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome."|Baseline and Month 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621825|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Short of Breath or Headache - Month 6 - (MITT)|"Change from Baseline to Month 6 in MOS Sleep Short of Breath or Headache(SOBHA) individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. SOBHA item is Q5. Scoring method: Answer to Q5 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome."|Baseline and Month 6|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621826|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Short of Breath or Headache - Week 12 - (MITT)|"Change from Baseline to Wk 12 in MOS Sleep Short of Breath or Headache(SOBHA) individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. SOBHA item is Q5. Scoring method: Answer to Q5 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome."|Baseline and Week 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621827|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Snoring - Month 12 - (MITT)|"Change from Baseline to Month 12 in MOS Snoring individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Snoring item is Q10. Scoring method: Answer to Q10 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome."|Baseline and Month 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621828|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Snoring - Month 6 - (MITT)|"Change from Baseline to Month 6 in MOS Snoring individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Snoring item is Q10. Scoring method: Answer to Q10 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome."|Baseline and Month 6|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621829|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Snoring - Week 12 - (MITT)|"Change from Baseline to Wk 12 in MOS Snoring individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Snoring item is Q10. Scoring method: Answer to Q10 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome."|Baseline and Week 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2622286|NCT01940120|Secondary|Cardiac Output|CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min)|24 months|Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Cardiac output evaluation was not done or un-evaluable.|||l/min||Standard Deviation|Mean
2621830|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Disturbance - Month 12 - (MITT)|"Change from Baseline to Month 12 in MOS Sleep Disturbance individual score as compared with Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep disturbance includes items Q1, Q3, Q7, Q8. Scoring method: Answer to Q1 is rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25. Answers to Q3, 7, 8 are reversed & rescaled to realign to be same direction and range(0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Score is average of item scores; score range=0 to 100, where higher score means worse outcome."|Baseline and Month 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621831|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Disturbance - Month 6 - (MITT)|"Change from Baseline to Month 6 in MOS Sleep Disturbance individual score as compared with Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep disturbance includes items Q1, Q3, Q7, Q8. Scoring method: Answer to Q1 is rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25. Answers to Q3, 7, 8 are reversed & rescaled to realign to be same direction and range(0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Score is average of item scores; score range=0 to 100, where higher score means worse outcome."|Baseline and Month 6|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621832|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Disturbance - Week 12 - (MITT)|"Change from Baseline to Wk 12 in MOS Sleep Disturbance individual score as compared with Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep disturbance includes items Q1, Q3, Q7, Q8. Scoring method: Answer to Q1 is rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25. Answers to Q3, 7, 8 are reversed & rescaled to realign to be same direction and range(0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Score is average of item scores; score range=0 to 100, where higher score means worse outcome."|Baseline and Week 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621833|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Sleep Scale - Total Sleep Score - Month 12 (MITT)|"Change from Baseline to Month 12 in MOS Total Sleep Score as compared w/Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Total score includes items Q1, 3, 4, 5, 6, 7, 8, 9, & 12. Scoring method: Answers to Q3, 5, 6, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q1, 4, & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Total score= average of item scores; ranges =0 to 100, where higher score means worse outcome. If any of individual questions used to obtain total score is missing, total score will be set to missing value."|Baseline and Month 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621834|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Sleep Scale - Total Sleep Score - Month 6 (MITT)|"Change from Baseline to Month 6 in MOS Total Sleep Score as compared w/Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Total score includes items Q1, 3, 4, 5, 6, 7, 8, 9, & 12. Scoring method: Answers to Q3, 5, 6, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q1, 4, & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Total score= average of item scores; ranges =0 to 100, where higher score means worse outcome. If any of individual questions used to obtain total score is missing, total score will be set to missing value."|Baseline and Month 6|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621835|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Sleep Scale - Total Sleep Score - Week 12 (MITT)|"Change from Baseline to Wk 12 in MOS Total Sleep Score as compared w/Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Total score includes items Q1, 3, 4, 5, 6, 7, 8, 9, & 12. Scoring method: Answers to Q3, 5, 6, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q1, 4, & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Total score= average of item scores; ranges =0 to 100, where higher score means worse outcome. If any of individual questions used to obtain total score is missing, total score will be set to missing value."|Baseline and Week 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621836|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Overall Scores - Month 12 (MITT)|"Change in Overall Scores from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. The scale contains four domains: vasomotor, psychosocial, physical and sexual. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The Overall Score is the mean of the 4 domain scores with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621837|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Overall Scores - Month 6 (MITT)|"Change in Overall Scores from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. The scale contains four domains: vasomotor, psychosocial, physical and sexual. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The Overall Score is the mean of the 4 domain scores with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 6|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621838|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Overall Scores - Week 12 (MITT)|"Change in Overall Scores from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. The scale contains four domains: vasomotor, psychosocial, physical and sexual. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The Overall Score is the mean of the 4 domain scores with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Week 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621839|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Sexual Domain Score - Month 12 (MITT)|"Changes in Sexual Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Sexual domain score is mean of = Q27 to Q29, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621840|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Sexual Domain Score - Month 6 (MITT)|"Changes in Sexual Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Sexual domain score is mean of = Q27 to Q29, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 6|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621841|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Sexual Domain Score - Week 12 (MITT)|"Changes in Sexual Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Sexual domain score is mean of = Q27 to Q29, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Week 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621842|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Physical Domain Score - Month 12 (MITT)|"Changes in Physical Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Physical domain score is mean of = Q11 to Q26, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621843|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Physical Domain Score - Month 6 (MITT)|"Changes in Physical Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Physical domain score is mean of = Q11 to Q26, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 6|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621844|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Physical Domain Score - Week 12 (MITT)|"Changes in Physical Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Physical domain score is mean of = Q11 to Q26, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Week 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2624513|NCT01923480|Secondary|Plasma Concentration of Alanine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
2621845|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Psychosocial Domain Score - Month 12 (MITT)|"Changes in Psychosocial Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Psychosocial domain score is mean of = Q4 to Q10, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621846|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Psychosocial Domain Score - Month 6 (MITT)|"Changes in Psychosocial Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Psychosocial domain score is mean of = Q4 to Q10, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 6|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621847|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Psychosocial Domain Score - Week 12 (MITT)|"Changes in Psychosocial Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Psychosocial domain score is mean of = Q4 to Q10, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Week 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621848|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Vasomotor Domain Score - Month 12 (MITT)|"Changes in Vasomotor Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Vasomotor domain score is mean of = Q1,Q2, Q3, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621849|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Vasomotor Domain Score - Month 6 (MITT)|"Changes in Vasomotor Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Vasomotor domain score is mean of = Q1,Q2, Q3, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 6|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621850|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Vasomotor Domain Score - Week 12 (MITT)|"Changes in Vasomotor Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Vasomotor domain score is mean of = Q1,Q2, Q3, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Week 12|All randomized subjects who took at least one dose (2 capsules) of IP.|||score on a scale||Standard Deviation|Mean
2621851|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Optimal Sleep - Month 12 - (MITT-VMS)|Change from Baseline (BL) to Month 12 in MOS Optimal Sleep Score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items measuring 6 dimensions of sleep over the past 4 wks. Optimal sleep is based on Q2 (self-reported average hrs sleep per night in past 4 wks). Scoring method: hrs of sleep coded 0 (non-optimal) or 1 (optimal) where 1-6 hrs & 9-23 hrs = 0, 7-8 hrs = 1. Change from BL: subject sleeps 7-8 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = -1; subject sleeps 1-6 or 9-23 hrs at BL & 7-8 hrs at follow-up, change = +1; subject sleeps 1-6 or 9-23 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = 0. Mean change from BL: changes are summed to give the Net Total (equivalent to the number subjects w/ improved sleep hrs minus the number subjects w/ worsened sleep hrs), which is divided by the number of subjects to give the mean proportion of net change, where >0 = overall improvement and <0 = overall worsening in the study arm.|Baseline and Month 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Proportion of Net Change||Standard Deviation|Mean
2621934|NCT01942668|Secondary|Number of Subjects Without Bleeding for Consecutive Cycles|No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.|Cycle 1 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621852|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Optimal Sleep - Month 6 - (MITT-VMS)|Change from Baseline (BL) to Month 6 in MOS Optimal Sleep Score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items measuring 6 dimensions of sleep over the past 4 wks. Optimal sleep is based on Q2 (self-reported average hrs sleep per night in past 4 wks). Scoring method: hrs of sleep coded 0 (non-optimal) or 1 (optimal) where 1-6 hrs & 9-23 hrs = 0, 7-8 hrs = 1. Change from BL: subject sleeps 7-8 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = -1; subject sleeps 1-6 or 9-23 hrs at BL & 7-8 hrs at follow-up, change = +1; subject sleeps 1-6 or 9-23 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = 0. Mean change from BL: changes are summed to give the Net Total (equivalent to the number subjects w/ improved sleep hrs minus the number subjects w/ worsened sleep hrs), which is divided by the number of subjects to give the mean proportion of net change, where >0 = overall improvement and <0 = overall worsening in the study arm.|Baseline and Month 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Proportion of Net Change||Standard Deviation|Mean
2621853|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Optimal Sleep - Week 12 - (MITT-VMS)|Change from Baseline (BL) to Week 12 in MOS Optimal Sleep Score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items measuring 6 dimensions of sleep over the past 4 wks. Optimal sleep is based on Q2 (self-reported average hrs sleep per night in past 4 wks). Scoring method: hrs of sleep coded 0 (non-optimal) or 1 (optimal) where 1-6 hrs & 9-23 hrs = 0, 7-8 hrs = 1. Change from BL: subject sleeps 7-8 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = -1; subject sleeps 1-6 or 9-23 hrs at BL & 7-8 hrs at follow-up, change = +1; subject sleeps 1-6 or 9-23 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = 0. Mean change from BL: changes are summed to give the Net Total (equivalent to the number subjects w/ improved sleep hrs minus the number subjects w/ worsened sleep hrs), which is divided by the number of subjects to give the mean proportion of net change, where >0 = overall improvement and <0 = overall worsening in the study arm.|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Proportion of Net Change||Standard Deviation|Mean
2621854|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index II - Month 12 - (MITT-VMS)|"Change from Baseline to Month 12 in MOS Sleep Problems Index II individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index II items include Q1, Q3, Q4, Q5, Q6, Q7, Q8, Q9, Q12. Scoring method: Answers to Q3, 5, 6, 7, 8, & 9 are reversed & rescaled to realign to be same direction and range 0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20, for n=Q3, 5, 6, 7, 8, and 9. Answers to Q1, 4 & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome."|Baseline and Month 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621855|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index II - Month 6 - (MITT-VMS)|"Change from Baseline to Month 6 in MOS Sleep Problems Index II individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index II items include Q1, Q3, Q4, Q5, Q6, Q7, Q8, Q9, Q12. Scoring method: Answers to Q3, 5, 6, 7, 8, & 9 are reversed & rescaled to realign to be same direction and range 0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20, for n=Q3, 5, 6, 7, 8, and 9. Answers to Q1, 4 & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome."|Baseline and Month 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621856|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index II - Week 12 - (MITT-VMS)|"Change from Baseline to Wk 12 in MOS Sleep Problems Index II individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index II items include Q1, Q3, Q4, Q5, Q6, Q7, Q8, Q9, Q12. Scoring method: Answers to Q3, 5, 6, 7, 8, & 9 are reversed & rescaled to realign to be same direction and range 0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20, for n=Q3, 5, 6, 7, 8, and 9. Answers to Q1, 4 & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome."|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2622185|NCT01941030|Primary|Change in Minimum Lumen Area Percent Stenosis as Assessed by IVUS|The pre- (Pre-Tx) and post-treatment (Post-Tx) minimum lumen area percent stenosis. A positive value equates to a decrease in lumen area percent stenosis.|Pre-intervention, and post-balloon angioplasty|Not all subjects had reported IVUS data for each lesion pre- and post-treatment.|||percent of minimum area stenosis|lesions|Inter-Quartile Range|Median
2621857|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index I - Month 12 - (MITT-VMS)|"Change from Baseline to Month 12 in MOS Sleep Problems Index I individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index I includes items Q4, Q5, Q7, Q8, Q9, Q12. Scoring method: Answers to Q, 5, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q4, & 12 are rescaled to 0-100 as follows: MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome."|Baseline and Month 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621858|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index I - Month 6 - (MITT-VMS)|"Change from Baseline to Month 6 in MOS Sleep Problems Index I individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index I includes items Q4, Q5, Q7, Q8, Q9, Q12. Scoring method: Answers to Q, 5, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q4, & 12 are rescaled to 0-100 as follows: MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome."|Baseline and Month 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621859|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index I - Week 12 - (MITT-VMS)|"Change from Baseline to Wk 12 in MOS Sleep Problems Index I individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index I includes items Q4, Q5, Q7, Q8, Q9, Q12. Scoring method: Answers to Q, 5, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q4, & 12 are rescaled to 0-100 as follows: MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome."|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621860|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Somnolence - Month 12 - (MITT-VMS)|"Change from Baseline to Month 12 in MOS Sleep Somnolence individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Somnolence items include Q6, Q9, Q11. Scoring method: Answers to Q6, Q 9 and Q11 are reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome."|Baseline and Month 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621861|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Somnolence - Month 6 - (MITT-VMS)|"Change from Baseline to Month 6 in MOS Sleep Somnolence individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Somnolence items include Q6, Q9, Q11. Scoring method: Answers to Q6, Q 9 and Q11 are reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome."|Baseline and Month 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621868|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Short of Breath or Headache - Week 12 - (MITT-VMS)|"Change from Baseline to Wk 12 in MOS Sleep Short of Breath or Headache(SOBHA) individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. SOBHA item is Q5. Scoring method: Answer to Q5 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome."|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621862|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Somnolence - Week 12 - (MITT-VMS)|"Change from Baseline to Wk 12 in MOS Sleep Somnolence individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Somnolence items include Q6, Q9, Q11. Scoring method: Answers to Q6, Q 9 and Q11 are reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome."|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621863|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Adequacy - Month 12 - (MITT-VMS)|Change from Baseline to Month 12 in MOS Sleep Adequacy individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Adequacy includes items Q4, Q12. Scoring method: Answers for Q4 and Q12 are reversed and rescaled to 0-100 as follows: MOS_4_new = (6-MOS_4_old) x 20; MOS_12_new = (6-MOS_12_old) x 20. Score is the average of item scores; score range = 0 to 100, where higher score means better outcome.|Baseline and Month 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621864|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Adequacy - Month 6 - (MITT-VMS)|Change from Baseline to Month 6 in MOS Sleep Adequacy individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Adequacy includes items Q4, Q12. Scoring method: Answers for Q4 and Q12 are reversed and rescaled to 0-100 as follows: MOS_4_new = (6-MOS_4_old) x 20; MOS_12_new = (6-MOS_12_old) x 20. Score is the average of item scores; score range = 0 to 100, where higher score means better outcome.|Baseline and Month 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621865|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Adequacy - Week 12 - (MITT-VMS)|Change from Baseline to Wk 12 in MOS Sleep Adequacy individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Adequacy includes items Q4, Q12. Scoring method: Answers for Q4 and Q12 are reversed and rescaled to 0-100 as follows: MOS_4_new = (6-MOS_4_old) x 20; MOS_12_new = (6-MOS_12_old) x 20. Score is the average of item scores; score range = 0 to 100, where higher score means better outcome.|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621866|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Short of Breath or Headache - Month 12 - (MITT-VMS)|"Change from Baseline to Month 12 in MOS Sleep Short of Breath or Headache(SOBHA) individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. SOBHA item is Q5. Scoring method: Answer to Q5 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome."|Baseline and Month 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621867|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Short of Breath or Headache - Month 6 - (MITT-VMS)|"Change from Baseline to Month 6 in MOS Sleep Short of Breath or Headache(SOBHA) individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. SOBHA item is Q5. Scoring method: Answer to Q5 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome."|Baseline and Month 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621905|NCT01942668|Secondary|Subject Incidence With Spotting - Trimester 4 (Safety Pop.)|Summary of subject incidence with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.|Trimester 4|Subjects who had taken at least one dose (2 capsules) of IP and had at least one bleeding/spotting diary entry for Trimester 4. Subjects who reported bleeding/spotting diary only for partial trimester are also included.|||Participants|||Count of Participants
2621869|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Snoring - Month 12 - (MITT-VMS)|"Change from Baseline to Month 12 in MOS Snoring individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Snoring item is Q10. Scoring method: Answer to Q10 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome."|Baseline and Month 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621870|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Snoring - Month 6 - (MITT-VMS)|"Change from Baseline to Month 6 in MOS Snoring individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Snoring item is Q10. Scoring method: Answer to Q10 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome."|Baseline and Month 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621871|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Snoring - Week 12 - (MITT-VMS)|"Change from Baseline to Wk 12 in MOS Snoring individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Snoring item is Q10. Scoring method: Answer to Q10 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome."|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621872|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Disturbance - Month 12 - (MITT-VMS)|"Change from Baseline to Month 12 in MOS Sleep Disturbance individual score as compared with Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep disturbance includes items Q1, Q3, Q7, Q8. Scoring method: Answer to Q1 is rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25. Answers to Q3, 7, 8 are reversed & rescaled to realign to be same direction and range(0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Score is average of item scores; score range=0 to 100, where higher score means worse outcome."|Baseline and Month 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621873|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Disturbance - Month 6 - (MITT-VMS)|"Change from Baseline to Month 6 in MOS Sleep Disturbance individual score as compared with Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep disturbance includes items Q1, Q3, Q7, Q8. Scoring method: Answer to Q1 is rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25. Answers to Q3, 7, 8 are reversed & rescaled to realign to be same direction and range(0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Score is average of item scores; score range=0 to 100, where higher score means worse outcome."|Baseline and Month 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621874|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Disturbance - Week 12 (MITT-VMS)|"Change from Baseline to Wk 12 in MOS Sleep Disturbance individual score as compared with Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep disturbance includes items Q1, Q3, Q7, Q8. Scoring method: Answer to Q1 is rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25. Answers to Q3, 7, 8 are reversed & rescaled to realign to be same direction and range(0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Score is average of item scores; score range=0 to 100, where higher score means worse outcome."|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621906|NCT01942668|Secondary|Subject Incidence With Spotting - Trimester 3 (Safety Pop.)|Summary of subject incidence with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.|Trimester 3|Subjects who had taken at least one dose (2 capsules) of IP and had at least one bleeding/spotting diary entry for Trimester 3. Subjects who reported bleeding/spotting diary only for partial trimester are also included.|||Participants|||Count of Participants
2621875|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Sleep Scale - Total Sleep Score - Month 12 (MITT-VMS)|"Change from Baseline to Month 12 in MOS Total Sleep Score as compared w/Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Total score includes items Q1, 3, 4, 5, 6, 7, 8, 9, & 12. Scoring method: Answers to Q3, 5, 6, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q1, 4, & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Total score= average of item scores; ranges =0 to 100, where higher score means worse outcome. If any of individual questions used to obtain total score is missing, total score will be set to missing value."|Baseline and Month 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621876|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Sleep Scale - Total Sleep Score - Month 6 (MITT-VMS)|"Change from Baseline to Month 6 in MOS Total Sleep Score as compared w/Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Total score includes items Q1, 3, 4, 5, 6, 7, 8, 9, & 12. Scoring method: Answers to Q3, 5, 6, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q1, 4, & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Total score= average of item scores; ranges =0 to 100, where higher score means worse outcome. If any of individual questions used to obtain total score is missing, total score will be set to missing value."|Baseline and Month 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621877|NCT01942668|Secondary|Medical Outcomes Sleep Study (MOS) Sleep Scale - Total Sleep Score - Week 12 (MITT-VMS)|"Change from Baseline to Wk 12 in MOS Total Sleep Score as compared w/Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Total score includes items Q1, 3, 4, 5, 6, 7, 8, 9, & 12. Scoring method: Answers to Q3, 5, 6, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q1, 4, & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Total score= average of item scores; ranges =0 to 100, where higher score means worse outcome. If any of individual questions used to obtain total score is missing, total score will be set to missing value."|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621878|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Overall Scores - Month 12 (MITT-VMS)|"Changes in Overall Scores from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. The scale contains four domains: vasomotor, psychosocial, physical and sexual. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The Overall Score is the mean of the 4 domain scores with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621879|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Overall Scores - Month 6 (MITT-VMS)|"Changes in Overall Scores from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. The scale contains four domains: vasomotor, psychosocial, physical and sexual. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The Overall Score is the mean of the 4 domain scores with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621907|NCT01942668|Secondary|Subject Incidence With Spotting - Trimester 2 (Safety Pop.)|Summary of subject incidence with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.|Trimester 2|Subjects who had taken at least one dose (2 capsules) of IP and had at least one bleeding/spotting diary entry for Trimester 2. Subjects who reported bleeding/spotting diary only for partial trimester are also included.|||Participants|||Count of Participants
2621908|NCT01942668|Secondary|Subject Incidence With Spotting - Trimester 1 (Safety Pop.)|Summary of subject incidence with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.|Trimester 1|Subjects who had taken at least one dose (2 capsules) of IP and had at least one bleeding/spotting diary entry for Trimester 1. Subjects who reported bleeding/spotting diary only for partial trimester are also included.|||Participants|||Count of Participants
2621880|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Overall Scores - Week 12 (MITT-VMS)|"Changes in Overall Scores from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. The scale contains four domains: vasomotor, psychosocial, physical and sexual. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The Overall Score is the mean of the 4 domain scores with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621881|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Sexual Domain Score - Month 12 (MITT-VMS)|"Changes in Sexual Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Sexual domain score is mean of = Q27 to Q29, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621882|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Sexual Domain Score - Month 6 (MITT-VMS)|"Changes in Sexual Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Sexual domain score is mean of = Q27 to Q29, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621883|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Sexual Domain Score - Week 12 (MITT-VMS)|"Changes in Sexual Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Sexual domain score is mean of = Q27 to Q29, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621884|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Physical Domain Score - Month 12 (MITT-VMS)|"Changes in Physical Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Physical domain score is mean of = Q11 to Q26, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621885|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Physical Domain Score - Month 6 (MITT-VMS)|"Changes in Physical Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Physical domain score is mean of = Q11 to Q26, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621932|NCT01942668|Secondary|Number of Subjects Without Bleeding for Consecutive Cycles|No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.|Cycle 3 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621886|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Physical Domain Score - Week 12 (MITT-VMS)|"Changes in Physical Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Physical domain score is mean of = Q11 to Q26, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621887|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Psychosocial Domain Score - Month 12 (MITT-VMS)|"Changes in Psychosocial Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Psychosocial domain score is mean of = Q4 to Q10, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621888|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Psychosocial Domain Score - Month 6 (MITT-VMS)|"Changes in Psychosocial Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Psychosocial domain score is mean of = Q4 to Q10, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621889|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Psychosocial Domain Score - Week 12 (MITT-VMS)|"Changes in Psychosocial Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Psychosocial domain score is mean of = Q4 to Q10, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621890|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Vasomotor Domain Score - Month 12 (MITT-VMS)|"Changes in Vasomotor Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Vasomotor domain score is mean of = Q1,Q2, Q3, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621891|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Vasomotor Domain Score - Month 6 (MITT-VMS)|"Changes in Vasomotor Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Vasomotor domain score is mean of = Q1,Q2, Q3, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Month 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||score on a scale||Standard Deviation|Mean
2621933|NCT01942668|Secondary|Number of Subjects Without Bleeding for Consecutive Cycles|No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.|Cycle 2 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621892|NCT01942668|Secondary|Menopause-specific Quality of Life Questionnaire (MENQOL) - Vasomotor Domain Score - Week 12 (MITT-VMS)|"Changes in Vasomotor Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Vasomotor domain score is mean of = Q1,Q2, Q3, with 1 being not at all bothered and 8 being extremely bothered."|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Score on a Scale||Standard Deviation|Mean
2621893|NCT01942668|Secondary|Number of Days With Bleeding - Trimester 4 (Safety Pop.)|Summary of the number of days with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.|Trimester 4|Subjects who had taken at least one dose (2 capsules) of IP and had at least one bleeding/spotting diary entry for Trimester 4. Subjects who reported bleeding/spotting diary only for partial trimester are also included.|||Days||Standard Deviation|Mean
2621894|NCT01942668|Secondary|Number of Days With Bleeding - Trimester 3 (Safety Pop.)|Summary of the number of days with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.|Trimester 3|Subjects who had taken at least one dose (2 capsules) of IP and had at least one bleeding/spotting diary entry for Trimester 3. Subjects who reported bleeding/spotting diary only for partial trimester are also included.|||Days||Standard Deviation|Mean
2621895|NCT01942668|Secondary|Number of Days With Bleeding - Trimester 2 (Safety Pop.)|Summary of the number of days with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.|Trimester 2|Subjects who had taken at least one dose (2 capsules) of IP and had at least one bleeding/spotting diary entry for Trimester 2. Subjects who reported bleeding/spotting diary only for partial trimester are also included.|||Days||Standard Deviation|Mean
2621896|NCT01942668|Secondary|Number of Days With Bleeding - Trimester 1 (Safety Pop.)|Summary of the number of days with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.|Trimester 1|Subjects who had taken at least one dose (2 capsules) of IP and had at least one bleeding/spotting diary entry for Trimester 1. Subjects who reported bleeding/spotting diary only for partial trimester are also included.|||Days||Standard Deviation|Mean
2621897|NCT01942668|Secondary|Subject Incidence With Bleeding - Trimester 4 (Safety Pop.)|Summary of subject incidence with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.|Trimester 4|Subjects who had taken at least one dose (2 capsules) of IP and had at least one bleeding/spotting diary entry for Trimester 4. Subjects who reported bleeding/spotting diary only for partial trimester are also included.|||Participants|||Count of Participants
2621898|NCT01942668|Secondary|Subject Incidence With Bleeding - Trimester 3 (Safety Pop.)|Summary of subject incidence with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.|Trimester 3|Subjects who had taken at least one dose (2 capsules) of IP and had at least one bleeding/spotting diary entry for Trimester 3. Subjects who reported bleeding/spotting diary only for partial trimester are also included.|||Participants|||Count of Participants
2621899|NCT01942668|Secondary|Subject Incidence With Bleeding - Trimester 2 (Safety Pop.)|Summary of subject incidence with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.|Trimester 2|Subjects who had taken at least one dose (2 capsules) of IP and had at least one bleeding/spotting diary entry for Trimester 2. Subjects who reported bleeding/spotting diary only for partial trimester are also included.|||Participants|||Count of Participants
2621900|NCT01942668|Secondary|Subject Incidence With Bleeding - Trimester 1 (Safety Pop.)|Summary of subject incidence with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.|Trimester 1|Subjects who had taken at least one dose (2 capsules) of IP and had at least one bleeding/spotting diary entry for Trimester 1. Subjects who reported bleeding/spotting diary only for partial trimester are also included.|||Participants|||Count of Participants
2621901|NCT01942668|Secondary|Number of Days With Spotting - Trimester 4 (Safety Pop.)|Summary of the number of days with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.|Trimester 4|Subjects who had taken at least one dose (2 capsules) of IP and had at least one bleeding/spotting diary entry for Trimester 4. Subjects who reported bleeding/spotting diary only for partial trimester are also included.|||Days||Standard Deviation|Mean
2621902|NCT01942668|Secondary|Number of Days With Spotting - Trimester 3 (Safety Pop.)|Summary of the number of days with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.|Trimester 3|Subjects who had taken at least one dose (2 capsules) of IP and had at least one bleeding/spotting diary entry for Trimester 3. Subjects who reported bleeding/spotting diary only for partial trimester are also included.|||Days||Standard Deviation|Mean
2621903|NCT01942668|Secondary|Number of Days With Spotting - Trimester 2 (Safety Pop.)|Summary of the number of days with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.|Trimester 2|Subjects who had taken at least one dose (2 capsules) of IP and had at least one bleeding/spotting diary entry for Trimester 2. Subjects who reported bleeding/spotting diary only for partial trimester are also included.|||Days||Standard Deviation|Mean
2621904|NCT01942668|Secondary|Number of Days With Spotting - Trimester 1 (Safety Pop.)|Summary of the number of days with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.|Trimester 1|Subjects who had taken at least one dose (2 capsules) of IP and had at least one bleeding/spotting diary entry for Trimester 1. Subjects who reported bleeding/spotting diary only for partial trimester are also included.|||Days||Standard Deviation|Mean
2622223|NCT01940484|Secondary|Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study||Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6)|"Included all enrolled participants who were evaluable for this outcome measure and n represents number of participants evaluable at the specified time point."|||mcg||Standard Deviation|Mean
2621909|NCT01942668|Secondary|Number of Subjects With Cumulative Amenorrhea From the 13th Cycle|Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from the 13th Cycle was calculated and compared between active and placebo treatments.|The 13th Cycle|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621910|NCT01942668|Secondary|Number of Subjects With Cumulative Amenorrhea From Cycle 12 to 13|Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 12 to 13 was calculated and compared between active and placebo treatments.|Cycle 12 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621911|NCT01942668|Secondary|Number of Subjects With Cumulative Amenorrhea From Cycle 11 to 13|Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 11 to 13 was calculated and compared between active and placebo treatments.|Cycle 11 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621912|NCT01942668|Secondary|Number of Subjects With Cumulative Amenorrhea From Cycle 10 to 13|Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 10 to 13 was calculated and compared between active and placebo treatments.|Cycle 10 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621913|NCT01942668|Secondary|Number of Subjects With Cumulative Amenorrhea From Cycle 9 to 13|Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 9 to 13 was calculated and compared between active and placebo treatments.|Cycle 9 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621914|NCT01942668|Secondary|Number of Subjects With Cumulative Amenorrhea From Cycle 8 to 13|Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 8 to 13 was calculated and compared between active and placebo treatments.|Cycle 8 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621915|NCT01942668|Secondary|Number of Subjects With Cumulative Amenorrhea From Cycle 7 to 13|Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 7 to 13 was calculated and compared between active and placebo treatments.|Cycle 7 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621916|NCT01942668|Secondary|Number of Subjects With Cumulative Amenorrhea From Cycle 6 to 13|Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 6 to 13 was calculated and compared between active and placebo treatments.|Cycle 6 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621917|NCT01942668|Secondary|Number of Subjects With Cumulative Amenorrhea From Cycle 5 to 13|Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 5 to 13 was calculated and compared between active and placebo treatments.|Cycle 5 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621918|NCT01942668|Secondary|Number of Subjects With Cumulative Amenorrhea From Cycle 4 to 13|Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 4 to 13 was calculated and compared between active and placebo treatments.|Cycle 4 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2622224|NCT01940484|Primary|Mean Hemoglobin Value at Visit 7 (Month 6)||Visit 7 (Month 6)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||g/dL||Standard Deviation|Mean
2621919|NCT01942668|Secondary|Number of Subjects With Cumulative Amenorrhea From Cycle 3 to 13|Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 3 to 13 was calculated and compared between active and placebo treatments.|Cycle 3 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621920|NCT01942668|Secondary|Number of Subjects With Cumulative Amenorrhea From Cycle 2 to 13|Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 2 to 13 was calculated and compared between active and placebo treatments.|Cycle 2 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621921|NCT01942668|Secondary|Number of Subjects With Cumulative Amenorrhea From Cycle 1 to 13|Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 1 to 13 was calculated and compared between active and placebo treatments.|Cycle 1 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621922|NCT01942668|Secondary|Number of Subjects Without Bleeding for Consecutive Cycles|No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.|The 13th Cycle|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621923|NCT01942668|Secondary|Number of Subjects Without Bleeding for Consecutive Cycles|No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.|Cycle 12 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621924|NCT01942668|Secondary|Number of Subjects Without Bleeding for Consecutive Cycles|No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.|Cycle 11 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621925|NCT01942668|Secondary|Number of Subjects Without Bleeding for Consecutive Cycles|No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.|Cycle 10 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621926|NCT01942668|Secondary|Number of Subjects Without Bleeding for Consecutive Cycles|No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.|Cycle 9 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621927|NCT01942668|Secondary|Number of Subjects Without Bleeding for Consecutive Cycles|No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.|Cycle 8 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621928|NCT01942668|Secondary|Number of Subjects Without Bleeding for Consecutive Cycles|No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.|Cycle 7 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621929|NCT01942668|Secondary|Number of Subjects Without Bleeding for Consecutive Cycles|No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.|Cycle 6 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621930|NCT01942668|Secondary|Number of Subjects Without Bleeding for Consecutive Cycles|No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.|Cycle 5 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621931|NCT01942668|Secondary|Number of Subjects Without Bleeding for Consecutive Cycles|No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.|Cycle 4 to 13|Subjects who received study drug for at least 1 complete 28-day cycle (at least 23 days in length); subjects who reported bleeding days during a partial cycle are also included.|||Participants|||Count of Participants
2621935|NCT01942668|Secondary|Mean Change in Frequency of Moderate to Severe VMS for the Respective CGI Category - Week 12 (MITT-VMS)|Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 12 for the respective CGI category. The CGI score is a seven point scale where subjects were asked to rate the total improvement, whether or not in her judgment it was due entirely to drug treatment, compared to her condition at admission to the study. Scale: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. Results for the top two responses (Very Much Improved and Much Improved) and No Change or Worsening (Minimally worse, Much worse, Very much worse) were combined for each group and active treatment groups compare to placebo.|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2621936|NCT01942668|Secondary|Clinical Global Impression (CGI) - Week 12 (MITT-VMS)|The number and percentage of subjects for each possible response to the CGI at Week 12. The CGI score is a seven point scale where subjects were asked to rate the total improvement, whether or not in her judgment it was due entirely to drug treatment, compared to her condition at admission to the study. Scale: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. Results for the top two responses (Very Much Improved and Much Improved) and No Change or Worsening (Minimally worse, Much worse, Very much worse) were combined for each group and active treatment groups compare to placebo.|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621937|NCT01942668|Secondary|Mean Change in Frequency of Moderate to Severe VMS for the Respective CGI Category - Week 8 (MITT-VMS)|Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 8 for the respective CGI category. The CGI score is a seven point scale where subjects were asked to rate the total improvement, whether or not in her judgment it was due entirely to drug treatment, compared to her condition at admission to the study. Scale: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. Results for the top two responses (Very Much Improved and Much Improved) and No Change or Worsening (Minimally worse, Much worse, Very much worse) were combined for each group and active treatment groups compare to placebo.|Baseline and Week 8|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2621938|NCT01942668|Secondary|Clinical Global Impression (CGI) - Week 8 (MITT-VMS)|The number and percentage of subjects for each possible response to the CGI at Week 8. The CGI score is a seven point scale where subjects were asked to rate the total improvement, whether or not in her judgment it was due entirely to drug treatment, compared to her condition at admission to the study. Scale: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. Results for the top two responses (Very Much Improved and Much Improved) and No Change or Worsening (Minimally worse, Much worse, Very much worse) were combined for each group and active treatment groups compare to placebo.|Baseline and Week 8|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621939|NCT01942668|Secondary|Mean Change in Frequency of Moderate to Severe VMS for the Respective CGI Category - Week 4 (MITT-VMS)|Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 4 for the respective CGI category. The CGI score is a seven point scale where subjects were asked to rate the total improvement, whether or not in her judgment it was due entirely to drug treatment, compared to her condition at admission to the study. Scale: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. Results for the top two responses (Very Much Improved and Much Improved) and No Change or Worsening (Minimally worse, Much worse, Very much worse) were combined for each group and active treatment groups compare to placebo.|Baseline and Week 4|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2621940|NCT01942668|Secondary|Clinical Global Impression (CGI) - Week 4 (MITT-VMS)|The number and percentage of subjects for each possible response to the CGI at Week 4. The CGI score is a seven point scale where subjects were asked to rate the total improvement, whether or not in her judgment it was due entirely to drug treatment, compared to her condition at admission to the study. Scale: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. Results for the top two responses (Very Much Improved and Much Improved) and No Change or Worsening (Minimally worse, Much worse, Very much worse) were combined for each group and active treatment groups compare to placebo.|Baseline and Week 4|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621941|NCT01942668|Secondary|Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 12 - (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 12.|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2622225|NCT01940484|Primary|Mean Hemoglobin Value at Visit 6 (Month 5)||Visit 6 (Month 5)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||g/dL||Standard Deviation|Mean
2621942|NCT01942668|Secondary|Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 11 - (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 11.|Baseline and Week 11|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621943|NCT01942668|Secondary|Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 10 - (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 10.|Baseline and Week 10|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621944|NCT01942668|Secondary|Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 9 - (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 9.|Baseline and Week 9|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621945|NCT01942668|Secondary|Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 8 - (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 8.|Baseline and Week 8|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621946|NCT01942668|Secondary|Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 7 - (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 7.|Baseline and Week 7|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621947|NCT01942668|Secondary|Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 6 - (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 6.|Baseline and Week 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621948|NCT01942668|Secondary|Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 5 - (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 5.|Baseline and Week 5|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621949|NCT01942668|Secondary|Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 4 - (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 4.|Baseline and Week 4|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621950|NCT01942668|Secondary|Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 3 - (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 3.|Baseline and Week 3|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621951|NCT01942668|Secondary|Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 2 - (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 2.|Baseline and Week 2|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621952|NCT01942668|Secondary|Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 1 - (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 1.|Baseline and Week 1|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2622021|NCT01942590|Secondary|Late-Life Function and Disability Instrument (LLFDI)|The Late-Life Function & Disability Instrument (Late-Life FDI) is an evaluative outcome instrument for community-dwelling older adults. Highest score 240 = normal function and no disability, lowest score 0 = low levels of frequency of participating in life tasks.|Baseline, Week 18, Week 52|Participants who completed LLFDI at the visit. Data was not collected from any participants in the placebo group.|||units on a scale||Standard Deviation|Mean
2621953|NCT01942668|Secondary|Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 12 (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 12.|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621954|NCT01942668|Secondary|Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 11 (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 11.|Baseline and Week 11|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621955|NCT01942668|Secondary|Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 10 (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 10.|Baseline and Week 10|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621956|NCT01942668|Secondary|Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 9 (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 9.|Baseline and Week 9|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621957|NCT01942668|Secondary|Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 8 (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 8.|Baseline and Week 8|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621958|NCT01942668|Secondary|Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 7 (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 7.|Baseline and Week 7|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621959|NCT01942668|Secondary|Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 6 (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 6.|Baseline and Week 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621960|NCT01942668|Secondary|Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 5 (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 5.|Baseline and Week 5|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621961|NCT01942668|Secondary|Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 4 (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 4.|Baseline and Week 4|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621962|NCT01942668|Secondary|Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 3 (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 3.|Baseline and Week 3|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621963|NCT01942668|Secondary|Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 2 (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 2.|Baseline and Week 2|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621964|NCT01942668|Secondary|Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 1 (MITT-VMS)|Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe VMS from Baseline to Week 1.|Baseline and Week 1|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||Participants|||Count of Participants
2621965|NCT01942668|Secondary|Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 12 (MITT-VMS)|Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621966|NCT01942668|Secondary|Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 11 (MITT-VMS)|Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 11. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 11|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621967|NCT01942668|Secondary|Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 10 (MITT-VMS)|Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 10. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 10|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621968|NCT01942668|Secondary|Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 9 (MITT-VMS)|Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 9. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 9|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621969|NCT01942668|Secondary|Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 8 (MITT-VMS)|Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 8. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 8|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621970|NCT01942668|Secondary|Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 7 (MITT-VMS)|Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 7. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 7|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621971|NCT01942668|Secondary|Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 6 (MITT-VMS)|Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 6. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621972|NCT01942668|Secondary|Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 5 (MITT-VMS)|Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 5. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 5|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621973|NCT01942668|Secondary|Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 4 (MITT-VMS)|Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 4|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621974|NCT01942668|Secondary|Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 3 (MITT-VMS)|Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 3. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 3|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621975|NCT01942668|Secondary|Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 2 (MITT-VMS)|Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 2. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 2|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621976|NCT01942668|Secondary|Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 1 (MITT-VMS)|Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 1. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 1|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621977|NCT01942668|Secondary|Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 12 (MITT-VMS)|Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2621978|NCT01942668|Secondary|Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 11 (MITT-VMS)|Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 11. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.|Baseline and Week 11|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2621979|NCT01942668|Secondary|Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 10 (MITT-VMS)|Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 10. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.|Baseline and Week 10|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2621980|NCT01942668|Secondary|Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 9 (MITT-VMS)|Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 9. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.|Baseline and Week 9|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2621981|NCT01942668|Secondary|Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 8 (MITT-VMS)|Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 8. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.|Baseline and Week 8|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2621982|NCT01942668|Secondary|Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 7 (MITT-VMS)|Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 7. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.|Baseline and Week 7|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2621983|NCT01942668|Secondary|Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 6 (MITT-VMS)|Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 6. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.|Baseline and Week 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2621984|NCT01942668|Secondary|Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 5 (MITT-VMS)|Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 5. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.|Baseline and Week 5|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2621985|NCT01942668|Secondary|Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 4 (MITT-VMS)|Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.|Baseline and Week 4|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2621986|NCT01942668|Secondary|Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 3 (MITT-VMS)|Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 3. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.|Baseline and Week 3|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2621987|NCT01942668|Secondary|Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 2 (MITT-VMS)|Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 2. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.|Baseline and Week 2|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2621988|NCT01942668|Secondary|Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 1 (MITT-VMS)|Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 1. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.|Baseline and Week 1|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2621989|NCT01942668|Secondary|Severity of Moderate to Severe Vasomotor Symptoms - Week 12 (MITT-VMS)|Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621990|NCT01942668|Secondary|Severity of Moderate to Severe Vasomotor Symptoms - Week 11 (MITT-VMS)|Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 11. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 11|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621991|NCT01942668|Secondary|Severity of Moderate to Severe Vasomotor Symptoms - Week 10 (MITT-VMS)|Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 10. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 10|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2622226|NCT01940484|Primary|Mean Hemoglobin Value at Visit 5 (Month 4)||Visit 5 (Month 4)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||g/dL||Standard Deviation|Mean
2621992|NCT01942668|Secondary|Severity of Moderate to Severe Vasomotor Symptoms - Week 9 (MITT-VMS)|Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 9. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 9|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621993|NCT01942668|Secondary|Severity of Moderate to Severe Vasomotor Symptoms - Week 8 (MITT-VMS)|Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 8. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 8|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621994|NCT01942668|Secondary|Severity of Moderate to Severe Vasomotor Symptoms - Week 7 (MITT-VMS)|Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 7. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 7|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621995|NCT01942668|Secondary|Severity of Moderate to Severe Vasomotor Symptoms - Week 6 (MITT-VMS)|Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 6. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621996|NCT01942668|Secondary|Severity of Moderate to Severe Vasomotor Symptoms - Week 5 (MITT-VMS)|Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 5. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 5|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621997|NCT01942668|Secondary|Severity of Moderate to Severe Vasomotor Symptoms - Week 4 (MITT-VMS)|Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 4|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2622022|NCT01942590|Secondary|Quick Motor Function Test (QMFT)|The QMFT is a criterion referenced assessment designed to measure functional status and change in gross motor function over time and, in particular, to measure clinically relevant change. Consists of 16 motor function tests. Lowest score 0 = unable to perform motor function tests, highest score 64 = normal muscle function.|Baseline, Week 18, and Week 52||||units on a scale||Standard Deviation|Mean
2621998|NCT01942668|Secondary|Severity of Moderate to Severe Vasomotor Symptoms - Week 3 (MITT-VMS)|Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 3. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 3|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2621999|NCT01942668|Secondary|Severity of Moderate to Severe Vasomotor Symptoms - Week 2 (MITT-VMS)|Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 2. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 2|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2622000|NCT01942668|Secondary|Severity of Moderate to Severe Vasomotor Symptoms - Week 1 (MITT-VMS)|Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 1. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 1|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2622001|NCT01942668|Secondary|Frequency of Moderate to Severe Vasomotor Symptoms - Week 12 (MITT-VMS)|Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2622002|NCT01942668|Secondary|Frequency of Moderate to Severe Vasomotor Symptoms - Week 11 (MITT-VMS)|Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 11. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.|Baseline and Week 11|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2622003|NCT01942668|Secondary|Frequency of Moderate to Severe Vasomotor Symptoms - Week 10 (MITT-VMS)|Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 10. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.|Baseline and Week 10|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2622004|NCT01942668|Secondary|Frequency of Moderate to Severe Vasomotor Symptoms - Week 9 (MITT-VMS)|Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 9. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.|Baseline and Week 9|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2622227|NCT01940484|Primary|Mean Hemoglobin Value at Visit 4 (Month 3)||Visit 4 (Month 3)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||g/dL||Standard Deviation|Mean
2622005|NCT01942668|Secondary|Frequency of Moderate to Severe Vasomotor Symptoms - Week 8 (MITT-VMS)|Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 8. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.|Baseline and Week 8|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2622006|NCT01942668|Secondary|Frequency of Moderate to Severe Vasomotor Symptoms - Week 7 (MITT-VMS)|Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 7. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.|Baseline and Week 7|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2622007|NCT01942668|Secondary|Frequency of Moderate to Severe Vasomotor Symptoms - Week 6 (MITT-VMS)|Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 6. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.|Baseline and Week 6|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2622008|NCT01942668|Secondary|Frequency of Moderate to Severe Vasomotor Symptoms - Week 5 (MITT-VMS)|Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 5. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.|Baseline and Week 5|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2622009|NCT01942668|Secondary|Frequency of Moderate to Severe Vasomotor Symptoms - Week 4 (MITT-VMS)|Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.|Baseline and Week 4|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2622010|NCT01942668|Secondary|Frequency of Moderate to Severe Vasomotor Symptoms - Week 3 (MITT-VMS)|Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 3. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.|Baseline and Week 3|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2622011|NCT01942668|Secondary|Frequency of Moderate to Severe Vasomotor Symptoms - Week 2 (MITT-VMS)|Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 2. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.|Baseline and Week 2|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2622012|NCT01942668|Secondary|Frequency of Moderate to Severe Vasomotor Symptoms - Week 1 (MITT-VMS)|Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 1. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.|Baseline and Week 1|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2622228|NCT01940484|Primary|Mean Hemoglobin Value at Visit 3 (Month 2)||Visit 3 (Month 2)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||g/dL||Standard Deviation|Mean
2622013|NCT01942668|Secondary|Endometrial Protection - Hyperplasia|Endometrial biopsies centrally evaluated by 3 primary pathologists using criteria described in Blaustein's Pathology text. Pathologists classified biopsy into 1 of following 3 categories: Cat.1: Non-endometrial malignancy/non-hyperplasia; Cat.2: Endometrial hyperplasia; Cat.3: Endometrial malignancy. Consensus was reached when the 2 of 3 pathologist readers agreed on any of the above categories; if all three reads were disparate, the final diagnosis was based on the most severe diagnosis. Incidence rate calculated as: I=A/B where I=incidence rate at M12 evaluation, A=all new subjects with biopsies positive for endometrial hyperplasia during study but post-Baseline, B=all subjects with biopsies following M11 meeting the criteria specified plus all subjects with biopsies positive for endometrial hyperplasia by any of the pathologists before M11.|Baseline and Month 12|Randomized subjects who had taken at least 1 capsule, had no major protocol violations, acceptable biopsy at baseline (evaluable tissue, no endometrial hyperplasia, polyp or cancer), had a biopsy at month 12 (on or after Study Day 326) or had a diagnosis of endometrial hyperplasia prior to month 12.|||Participants|||Count of Participants
2622014|NCT01942668|Primary|Primary Safety Endpoint: Endometrial Protection - Hyperplasia|Endometrial biopsies centrally evaluated by 2 primary pathologists using criteria from Blaustein's Pathology text. Pathologists classified bx into 1 of following 3 categories: Cat.1: Non-endometrial malignancy/non-hyperplasia; Cat.2: Endometrial hyperplasia; Cat.3: Endometrial malignancy. Consensus reached when 2 primary pathologist agreed on any of above categories; if primary pathologists disagreed on presence of hyperplasia, result of 3rd pathologist was utilized and final decision regarding presence of hyperplasia was based on diagnosis of majority. If all 3 reads disparate, final diagnosis based on most severe dx. Incidence rate calculated as: I=A/B where I=incidence rate at M12 evaluation, A=all new subjects with biopsies positive for endometrial hyperplasia during study but post-Baseline, B=all subjects w/biopsies following M11 meeting criteria specified plus all subjects w/biopsies positive for endometrial hyperplasia by any pathologists before M11.|Baseline and Month 12|Randomized subjects who had taken at least 1 capsule, had no major protocol violations, acceptable biopsy at baseline (evaluable tissue, no endometrial hyperplasia, polyp or cancer), had a biopsy at month 12 (on or after Study Day 326) or had a diagnosis of endometrial hyperplasia prior to month 12.|||Participants|||Count of Participants
2622015|NCT01942668|Primary|Co-Primary Efficacy Endpoint: Severity of Moderate to Severe Vasomotor Symptoms (MITT-VMS)|Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2622016|NCT01942668|Primary|Co-Primary Efficacy Endpoint: Severity of Moderate to Severe Vasomotor Symptoms (MITT-VMS)|Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).|Baseline and Week 4|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||scores on a scale||Standard Deviation|Mean
2622017|NCT01942668|Primary|Co-Primary Efficacy Endpoint: Frequency of Moderate to Severe Vasomotor Symptoms (MITT-VMS)|Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.|Baseline and Week 12|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2622018|NCT01942668|Primary|Co-Primary Efficacy Endpoint: Frequency of Moderate to Severe Vasomotor Symptoms (MITT-VMS)|Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.|Baseline and Week 4|Randomized to the VMS Substudy, taken one dose of IP, and had at least 5 days of VMS diary data for baseline measurement of freq. & severity of moderate to severe hot flushes, and had at least 4 days of VMS diary data for 1 on-treatment week of reporting freq. & severity of hot flushes following initiation of IP.|||weekly hot flushes||Standard Deviation|Mean
2622019|NCT01942590|Secondary|Maximum Expiratory Pressure (MEP)|MEP reflects the strength of the abdominal muscles and other expiratory muscles.|Baseline, Week 18, and Week 52|Participants who completed the MEP testing|||percentage of MEP||Standard Deviation|Mean
2622020|NCT01942590|Secondary|Predicted Maximum Inspiration Pressure (MIP)|MIP is a measurement of inspiratory muscle weakness, including weakness of the diaphragm. MIP is decreased in Pompe disease and reflects weakness of respiratory muscles.|Baseline, Week 18, and Week 52|Participants who completed the MIP testing|||percentage of MIP||Standard Deviation|Mean
2622023|NCT01942590|Secondary|GSGC (Gait, Stairs, Gowers, Arising From a Chair.)|The GSGC is a criterion referenced assessment designed to measure functional status and change in gross motor function over time and, in particular, to measure clinically relevant change. Consists of 4 components: Gait, Climbing Stairs, Gower's Manuever, Arising From a Chair. Lowest score 4 = normal muscle function, highest score 27 = unable to perform motor function tests.|Baseline, Week 18, and Week 52|participants who completed GSGC testing|||units on a scale||Standard Deviation|Mean
2622024|NCT01942590|Secondary|Change in Urinary Glc4 Biomarker||Baseline, Week 52|participants who completed urinary Glc4 biomarker collection|||mmol/mol CN||Standard Deviation|Mean
2622025|NCT01942590|Secondary|Change in Urinary Glc4 Biomarker|The Glc4 biomarker is measured in urine and correlates with muscle glycogen content. It is a noninvasive measurement that serves as a biomarker for Pompe disease.|Baseline, Week 18||||mmol/mol CN||Standard Deviation|Mean
2622026|NCT01942590|Secondary|Change in Forced Vital Capacity (FVC) in Pulmonary Function Testing|Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.|Baseline, Week 52|participants who completed FVC testing|||change in FVC measured as % expected||Standard Deviation|Mean
2622027|NCT01942590|Secondary|Change in Forced Vital Capacity (FVC) in Pulmonary Function Testing|Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.|Baseline, Week 18|participants who completed FVC testing|||change in FVC measured as % expected||Standard Deviation|Mean
2622028|NCT01942590|Secondary|Change in 6 Minute Walk Test|Assess exercise tolerance in study patients; test administered by physical therapist. Subjects were asked to walk for 6 minutes, unassisted. The distance walked was recorded in meters.|Baseline, week 52|Participants who completed 6 minute walk test|||meters||Standard Deviation|Mean
2622029|NCT01942590|Secondary|Change in 6 Minute Walk Test|Assess exercise tolerance in study patients; test administered by physical therapist. Subjects were asked to walk for 6 minutes, unassisted. The distance walked was recorded in meters.|Baseline, week 18|Participants who completed 6 minute walk test|||meters||Standard Deviation|Mean
2622030|NCT01942590|Primary|Number of Participants With a Change in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Bilirubin Representing Liver Toxicity|Liver toxicity, as defined by a >3x increase in AST or ALT from the respective baseline values and/or an increase in direct, indirect or total bilirubin of >3x the upper limit of normal|Any point up to week 52||||participants|||Number
2622031|NCT01942590|Primary|Number of Participants With a Change in Creatine Kinase (CK) Reflecting Worsening of Muscle Involvement|Worsening muscle involvement, as defined by >3x increase in CK from baseline that is >2x the upper limit of normal|Any point up to week 52||||participants|||Number
2622032|NCT01942486|Primary|HIT-6 Score|The HIT-6 (Headache Impact Test) is a validated measure of the impact of headache on activities of daily living, functional health and well-being. The minimum score is 36 and the maximum score is 78. The higher the score, the more your headaches are adversely affecting activities of daily living. Patients who score higher than 50 are encouraged to seek help from their physician.|12 weeks|Only subjects that completed the trial were analyzed|||units on a scale||Standard Deviation|Mean
2622033|NCT01942161|Secondary|Mean Change From Baseline at Final Assessment in Children's Global Assessment Scale (C-GAS) Score|The Children's Global Assessment Scale (C-GAS) is a rating scale which measures psychological, social and school functioning for children aged 6-17. Scores range from 0 to 100, with higher scores indicating better condition.|Baseline (Day 1) and Day 43||||units on a scale||Standard Error|Mean
2622034|NCT01942161|Secondary|Mean Change From Baseline at Final Assessment in Clinical Global Impression-Improvement (CGI-I) Score|The Clinical Global Impression-Improvement (CGI-I) Score is a clinician rated scale which assesses the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition.|Baseline (Day 1) and day43||||units on a scale||Standard Error|Mean
2622035|NCT01942161|Secondary|Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score|The Clinical Global Impression-Severity of Illness (CGI-S) Score is a clinician rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition.|Baseline (Day 1) and Day43||||units on a scale||Standard Error|Mean
2622036|NCT01942161|Secondary|Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Total Score|The Positive and Negative Syndrome Scale (PANSS) positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49, with higher values indicating worse condition.|Baseline (Day 1) and Day 43||||units on a scale||Standard Error|Mean
2622037|NCT01942161|Primary|Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score|The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7: 1 =Absent, 2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme. PANSS total score is calculated by adding score of 30 items, which ranges from 30-210. Higher scores indicate worse condition.|Baseline (Day 1) and Day 43||||units on a scale||Standard Error|Mean
2622038|NCT01942148|Secondary|Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS)|The Children's Global Assessment Score (CGAS) is a rating scale which measures psychological, social and school functioning for children aged 6-17. Scores range from 0 to 100, with higher scores indicating better condition.|Baseline and Week52||||units on a scale||Standard Deviation|Mean
2622039|NCT01942148|Secondary|Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score|The Clinical Global Impression-Severity of Illness (CGI-S) Score is a clinician rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition.|Basline and Week52||||units on a scale||Standard Deviation|Mean
2622040|NCT01942148|Primary|Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score|The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7: 1 =Absent, 2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme. PANSS total score is calculated by adding score of 30 items, which ranges from 30-210. Higher scores indicate worse condition.|Basline and Week52||||units on a scale||Standard Deviation|Mean
2622041|NCT01942135|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)|An AE is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening; requires hospitalization; results in persistent or significant disability or in congenital anomaly/birth defect. Severity will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0.|From the signing of the informed consent until 28 days after the last dose of study medication up to 14 months|The as-treated (AT) population or safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.|||Percentage of Participants|||Number
2622042|NCT01942135|Secondary|Time to Deterioration (TTD)|A time to event analysis was pre-specified for pain. An analysis of TTD in pain defined as time between baseline and first occurrence of increase of ≥10 points in pain. Deterioration will be defined increase in score of 10 points or greater from baseline. The Kaplan-Meier estimates of quartiles (time to deterioration) with 95% CI is mentioned below.|Baseline, Day 1 of Cycles 2 to 4, Day 1 of every alternate cycle after that until the end of treatment|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment.|||Months||95% Confidence Interval|Median
2622043|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in EQ-5D Visual Analog Scale (VAS) Scores Scale|The EuroQol-5D (version 3L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|||Units on a scale||95% Confidence Interval|Mean
2622044|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in EuroQoL 5D (EQ-5D)- Health Index Scores|The EuroQol-5D (version 3L) is a brief self-administered, validated instrument consisting of 2 parts. The first part consists of 5 descriptors of current health state (mobility, self care, usual activities, pain/discomfort, and anxiety/ depression); a participant is asked to rate each state on a three level scale (1=no problem, 2=some problem, and 3=extreme problem) with higher levels indicating greater severity/ impairment Published weights are available that allow for the creation of a single summary score called the EQ-5D index, which basically ranges from 0 to 1 with low scores representing a higher level of dysfunction and 1 as perfect health. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|||Units on a scale||95% Confidence Interval|Mean
2622045|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in EORTC QLQ BR23 Symptom Scale Scores|The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from 'not at all' to 'very much'. All scores are converted to a 0 to 100 scale. For symptom-oriented scales, a higher score represent more severe symptoms.|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|||Units on a scale||95% Confidence Interval|Mean
2622046|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores|The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from 'not at all' to 'very much'. All scores are converted to a 0 to 100 scale. For functional scales, higher scores represent a better level of functioning.|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|||Units on a scale||95% Confidence Interval|Mean
2622088|NCT01941940|Primary|Change From Baseline in CDAI at Week 2|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 2|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2622047|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in EORTC QLQ-C30 Symptom Scale Scores|"The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from not at all to very much and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant."|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|||Units on a scale||95% Confidence Interval|Mean
2622048|NCT01942135|Secondary|Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores|"The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from not at all to very much and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant."|From Cycle 1 to 14, as of 05 December 2014.|The PRO –evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post –baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.|||Units on a scale||95% Confidence Interval|Mean
2622049|NCT01942135|Secondary|Ctrough for Goserelin|"Cmin for goserelin (if applicable). The method of dispersion applied here is percent coefficient of variation (%CV)."|Cycles 2/ Day 1 and Cycle 3/ Day 1|All participants who had PK blood samples collected for palbociclib and had at least one measured plasma drug concentration.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2622050|NCT01942135|Secondary|Ctrough for Fulvestrant|"Ctrough for Fulvestrant (if applicable). The method of dispersion applied here is percent coefficient of variation (%CV)."|Cycles 2/Day 1 and Cycle 3/Day 1|All participants who had PK blood samples collected for palbociclib and had at least one measured plasma drug concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2622051|NCT01942135|Secondary|Observed Plasma Trough Concentration (Ctrough) for Palbociclib|"Ctrough for palbociclib (if applicable). The method of dispersion applied here is percent coefficient of variation (%CV)."|Cycle 1/Day 15 and Cycle 2/Day 15|All participants who had PK blood samples collected for palbociclib and had at least one measured plasma drug concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2622052|NCT01942135|Secondary|Survival Probabilities at Months 12, 24 and 36|One-, Two- or Three-year Survival Probability is defined as the probability of survival 1 year, 2 or 3 years after the date of randomization based on the Kaplan-Meier estimate. Survival time was censored to last date the participant is known to be alive.|From randomization until death (assessed up to 36 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
2622053|NCT01942135|Secondary|Clinical Benefit Response (CBR)|CBR is defined as the overall complete response (CR), partial response (PR) , or stable disease (SD) ≥24 weeks according to the RECIST version 1.1. Clinical Benefit Response Rate (CBRR) is defined as the proportion of participants with CR, PR, or SD ≥24 weeks relative to all randomized participants and randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received antitumor treatment other than the study medication prior to reaching a CR or PR, a best response of SD ≥24 weeks, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR and a best response of SD ≥24 weeks was counted as non-responders in the assessment of CBR. Per RECIST v1.1 for target lesions and assessed by MRI: CR, disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.|From randomization until end of treatment (assessed up to 12 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized. Randomized participants with measurable disease at baseline was also included.|||percentage of participants||95% Confidence Interval|Number
2622054|NCT01942135|Secondary|Duration of Response (DR)|DR is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date was used. DR was calculated as [the date response ended (ie, date of PD or death) - first CR or PR date + 1)]/30.4. Kaplan-Meier estimate of median of the DR is provided below. No inferential statistical analysis were done for DR. The DR was only calculated for the participants with a CR or PR.|From randomization until end of treatment (assessed up to 12 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
2622229|NCT01940484|Primary|Mean Hemoglobin Value at Visit 2 (Month 1)||Visit 2 (Month 1)|Included all enrolled participants who were evaluable for this outcome at the specified timepoint.|||g/dL||Standard Deviation|Mean
2622055|NCT01942135|Secondary|Objective Response (OR)|OR is defined as the overall complete response (CR) or partial response (PR) according to the RECIST version 1.1 Objective Response Rate (ORR) is defined as the proportion of participants with CR or PR relative to all randomized participants and randomized participants with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment other than the study medication prior to reaching a CR or PR, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per response evaluation criteria in solid tumors criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), ≥30% decrease in the sum of the longest diameter of target lesions (longest for non-nodal and short axis for nodal target lesions); Overall Response (OR) = CR + PR.|From randomization until end of treatment (assessed up to 12 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized. Randomized participants with measurable disease at baseline was also included.|||percentage of participants||95% Confidence Interval|Number
2622056|NCT01942135|Secondary|Overall Survival (OS) - Number of Participants Who Died|OS is defined as the time from date of randomization to date of death due to any cause. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. For participants lacking survival data beyond the date of their last follow-up, the OS time was censored on the last date they were known to be alive. Participants lacking survival data beyond randomization were to have their OS times be censored at randomization. The length of OS was calculated as OS time (months) = [death date (censor date) - randomization date + 1]/30.4. No inferential statistical analysis were done because of the immaturity of the OS data.|From randomization until death (up to approximately 36 months)|The ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized.|||deaths|||Number
2622057|NCT01942135|Primary|Progression-Free Survival (PFS) as Assessed by the Investigator|PFS is the time from the date of randomization to the date of the first documentation of objective progression of disease (PD)or death due to any cause in absence of documented PD. Participants lacking an evaluation of tumor response after randomization had their PFS time censored on the date of randomization with the duration of a day. Participants with documentation of PD or death after a long interval (2 or more incomplete or non-evaluable assessments) since the last tumor assessment were censored at the time of last objective assessment that did not show PD. The length of PFS was calculated as PFS time (months) =[progression/death date(censor date) - randomization date + 1]/30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors(RECIST v1.1) a 20% increase in the sum of diameters of target lesions and the sum must also demonstrate an absolute increase of at least 5mm or unequivocal progression of existing non-target lesions or the appearance of new lesions.|From randomization date to date of first documentation of progression or death (assessed up to 12 months)|The intent-to-treat (ITT) population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received the study medication or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
2622058|NCT01941940|Secondary|Mean Soluble Interleukin-6 Receptor (sIL-6R) Concentration||Baseline, Weeks 12, 24, 38, 52, at early withdrawal (up to Week 52), at Follow-up Visit 2 (Week 76)|FAS; Here 'n' signifies the number of participants evaluable at specified time point.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2622059|NCT01941940|Secondary|Mean Tocilizumab Concentration||Baseline, Weeks 12, 24, 38, 52, at early withdrawal (up to Week 52), at Follow-up Visit 2 (Week 76)|FAS; Here 'n' signifies the number of participants evaluable at specified time point.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
2622060|NCT01941940|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Tocilizumab|Percentage of participants with positive results for ATA against tocilizumab at different time points is reported.|Baseline, Weeks 12, 24, 38, 52, at 8 weeks after last dose (up to Week 60), at early withdrawal (up to Week 52), at Follow-up Visits 1 (Week 64), 2 (Week 76), and 3 (Week 88)|FAS; Here, 'n' signifies the number of participants evaluable at specified time point.|||percentage of participants|||Number
2622061|NCT01941940|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) of Special Interest|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are AEs occurring between the first dose of study drug and up to 28 days after the last dose that were absent before treatment or that worsened relative to pre-treatment state. Following AEs were considered as AEs of special interest: anaphylactic reaction, hypersensitivity, stress cardiomyopathy, Gilbert's syndrome, gastrointestinal perforation, injection site erythema, injection site hypersensitivity, injection site irritation, injection site pruritus, arthritis bacterial, cellulitis, klebsiella infection, oral candidiasis, pneumonia, skin infection, vulvovaginal candidiasis, alanine aminotransferase increased, hepatic enzyme increased, brain neoplasm malignant, and urticaria.|Baseline up to 95 weeks|FAS|||percentage of participants|||Number
2622062|NCT01941940|Secondary|Treatment Compliance, as Assessed Using Participant Diary Cards and Return Records|Treatment Compliance was calculated as (total actual doses taken for the period) / (total planned or prescribed dose for the period) x 100.|Weeks 24 and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||percentage of planned dose||Standard Deviation|Mean
2622063|NCT01941940|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Weeks 24 and 52|PSQI is a questionnaire with 18 questions to assess sleep quality. The 18 questions are distributed to 7 elements (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction). A participant indicates how frequently each item was experienced on a scale from 0 to 3. The global score is the sum score of all 7 elements and ranges from 0-21 with higher values indicating worse sleep quality. A score of >/=5 indicates poor sleepers.|Baseline, Weeks 24 and 52|Per-protocol analysis set (PPAS) included all participants in FAS without any major protocol violation and who completed 24 weeks of treatment period. 'Overall Number of Participants Analyzed'=participants evaluable for this outcome; 'n'=participants evaluable at specified time point.|||units on a scale||Standard Deviation|Mean
2622064|NCT01941940|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Total Score at Weeks 2, 24, and 52|FACIT total score is sum of Functional Assessment of Cancer Therapy-General (FACT-G) score and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F; additional concerns) score. FACT-G is a core questionnaire that evaluates quality of life (QoL) in cancer population. FACT-G consists of 27 questions grouped in 4 domains of general health-related QoL: physical well-being, social/family well-being, emotional well-being, and functional well-being; each item ranges from 0 (not at all) to 4 (very much). FACT-G score ranges between 0-108. FACIT-F is a 13-item questionnaire that evaluates self-reported fatigue and its impact upon daily activities. Each item ranges from 0 (Not at all) to 4 (Very much). The sum of all responses result in the FACIT total score with a total possible range of 0 (better score) to 160 (worse score). Negative change from baseline represents a better QoL.|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||units on a scale||Standard Deviation|Mean
2622065|NCT01941940|Secondary|Missed Working Days Assessed Using Short Form-Health and Labor Questionnaire (SF-HLQ) Score at Weeks 24 and 52|The SF-HLQ assessed productivity losses related to health problems in individuals with paid or unpaid work and consisted of three modules (absenteeism from paid work, production losses without absenteeism from paid work and hindrance in the performance of paid and unpaid work). Any missed working days or number of worked days with reduced efficiency during the last month were reported.|Weeks 24 and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||days||Standard Deviation|Mean
2622066|NCT01941940|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 24, and 52|HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||units on a scale||Standard Deviation|Mean
2622067|NCT01941940|Secondary|Participant Pain VAS Score at Weeks 2, 24, and 52|Participants assessed their pain using a 0-100 mm VAS. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain.|Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||mm||Standard Deviation|Mean
2622068|NCT01941940|Secondary|Change From Baseline in PGDA VAS Score at Weeks 2, 24, and 52|The physician assessed participant's current disease activity on a 0-100 mm VAS, where 0 mm = no disease activity and 100 mm = maximum disease activity.|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||mm||Standard Deviation|Mean
2622069|NCT01941940|Secondary|Change From Baseline in PtGDA VAS Score at Weeks 2, 24, and 52|"Participants answered the following question: Considering all the ways your arthritis affects you, how are you feeling today. Participants responded by using a 0 - 100 millimeter (mm) VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||mm||Standard Deviation|Mean
2622070|NCT01941940|Secondary|Percentage of Non-DMARDs Dose Reductions and/or Discontinuation Events by Reasons|Percentage of Non-DMARDs dose reduction and/or discontinuation (Red/Dis) events is reported by different reasons.|Baseline up to Week 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants with non-DMARDs dose reductions and/or discontinuation.|||percentage of events|Non-DMARDs Dose Red/Dis Events||Number
2622071|NCT01941940|Secondary|Percentage of DMARDs Dose Reductions and/or Discontinuation Events by Reasons|Percentage of DMARDs dose reduction and/or discontinuation (Red/Dis) events is reported by different reasons.|Baseline up to Week 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants with DMARDs dose reductions and/or discontinuation.|||percentage of events|DMARDs Dose Red/Dis Events||Number
2622072|NCT01941940|Secondary|Association Between Disease Activity Parameter (SDAI) and Treatment Response Parameter (EULAR), Assessed Using Regression Coefficient|The SDAI is a numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS and CRP in mg/dL. SDAI total score= 0-86. EULAR response criteria (based on DAS28 score): Good responders (change from baseline >1.2 with DAS28 </=3.2); Moderate responders (change from baseline >1.2 with DAS28 >3.2 to </=5.1 or change from baseline >0.6 to </=1.2 with DAS28 </=5.1); Non-responders (change from baseline </=0.6 or change from baseline >0.6 and </=1.2 with DAS28 >5.1). Regression coefficient for relationship between SDAI and EULAR Good response at different time points is reported. Regression coefficient value range= not defined (any negative or positive value is possible). Higher positive value indicates greater extent of positive relationship and higher negative value indicates greater extent of negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||regression coefficient|||Number
2622089|NCT01941940|Primary|Change From Baseline in CDAI at Week 4|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 4|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2622073|NCT01941940|Secondary|Association Between Disease Activity Parameter (SDAI) and Treatment Response Parameters (ACR20, ACR50, and ACR70), Assessed Using Regression Coefficient|SDAI is a numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS and CRP in mg/dL. SDAI total score= 0-86. The ACR 20, 50, and 70 responses: >/=20%, 50%, and 70% improvement in TJC and SJC, and 20%, 50%, 70% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. Regression coefficients for relationship between SDAI and ACR responses (ACR20, ACR50, and ACR70) at different time points are reported. Regression coefficient value range= not defined (any negative or positive value is possible). Higher positive value indicates greater extent of positive relationship and higher negative value indicates greater extent of negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||regression coefficient|||Number
2622074|NCT01941940|Secondary|Association Between Disease Activity Parameter (CDAI) and Treatment Response Parameter (EULAR), Assessed Using Regression Coefficient|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. CDAI total score = 0-76. EULAR response criteria (based on DAS28 score): Good responders (change from baseline >1.2 with DAS28 </=3.2); Moderate responders (change from baseline >1.2 with DAS28 >3.2 to </=5.1 or change from baseline >0.6 to </=1.2 with DAS28 </=5.1); Non-responders (change from baseline </=0.6 or change from baseline >0.6 and </=1.2 with DAS28 >5.1). Regression coefficient for relationship between CDAI and EULAR Good response at different time points is reported. Regression coefficient value range= not defined (any negative or positive value is possible). Higher positive value indicates greater extent of positive relationship and higher negative value indicates greater extent of negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||regression coefficient|||Number
2622075|NCT01941940|Secondary|Association Between Disease Activity Parameter (CDAI) and Treatment Response Parameters (ACR20, ACR50, and ACR70), Assessed Using Regression Coefficient|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. CDAI total score = 0-76. The ACR 20, 50, and 70 responses: >/=20%, 50%, and 70% improvement in TJC and SJC, and 20%, 50%, 70% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. Regression coefficients for relationship between CDAI and ACR responses (ACR20, ACR50, and ACR70) at different time points are reported. Regression coefficient value range= not defined (any negative or positive value is possible). Higher positive value indicates greater extent of positive relationship and higher negative value indicates greater extent of negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||regression coefficient|||Number
2622076|NCT01941940|Secondary|Association Between Disease Activity Parameter (DAS28-ESR) and Treatment Response Parameter (EULAR), Assessed Using Regression Coefficient|DAS28-ESR is calculated from the TJC and SJC based on a 28-joint assessment, the ESR in mm/hour and PtGDA. DAS28-ESR total score= 0-9.4. EULAR response criteria (based on DAS28 score): Good responders (change from baseline >1.2 with DAS28 </=3.2); Moderate responders (change from baseline >1.2 with DAS28 >3.2 to </=5.1 or change from baseline >0.6 to </=1.2 with DAS28 </=5.1); Non-responders (change from baseline </=0.6 or change from baseline >0.6 and </=1.2 with DAS28 >5.1). Regression coefficient for relationship between DAS28-ESR and EULAR Good response at different time points is reported. Regression coefficient value range= not defined (any negative or positive value is possible). Higher positive value indicates greater extent of positive relationship and higher negative value indicates greater extent of negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||regression coefficient|||Number
2622077|NCT01941940|Secondary|Association Between Disease Activity Parameter (DAS28-ESR) and Treatment Response Parameters (ACR20, ACR50, and ACR70), Assessed Using Regression Coefficient|DAS28-ESR is calculated from the TJC and SJC based on a 28-joint assessment, the ESR in mm/hour and PtGDA. DAS28-ESR total score= 0-9.4. The ACR 20, 50, and 70 responses: >/=20%, 50%, and 70% improvement in TJC and SJC, and 20%, 50%, 70% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. Regression coefficients for relationship between DAS28-ESR and ACR responses (ACR20, ACR50, and ACR70) at different time points are reported. Regression coefficient value range= not defined (any negative or positive value is possible). Higher positive value indicates greater extent of positive relationship and higher negative value indicates greater extent of negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||regression coefficient|||Number
2622078|NCT01941940|Secondary|Association Between Disease Activity Parameters: CDAI and SDAI, Assessed Using Correlation Coefficient|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. CDAI total score = 0-76. Higher scores represent greater affectation due to disease activity. SDAI is a numerical sum of 5 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS and CRP in mg/dL. SDAI total score= 0-86. Higher scores indicate greater affectation due to disease activity. Correlation coefficient for relationship between CDAI and SDAI at different time points is reported. Correlation coefficient value range= -1 to 1. Higher positive value indicates greater positive relationship and higher negative value indicates greater negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||correlation coefficient|||Number
2622079|NCT01941940|Secondary|Association Between Disease Activity Parameters: DAS28-ESR and SDAI, Assessed Using Correlation Coefficient|DAS28-ESR is calculated from the TJC and SJC based on a 28-joint assessment, the ESR in mm/hour and PtGDA. DAS28-ESR total score= 0-9.4. Higher scores indicate greater affectation due to disease activity. SDAI is a numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS and CRP in mg/dL. SDAI total score= 0-86. Higher scores indicate greater affectation due to disease activity. Correlation coefficient for relationship between DAS28-ESR and SDAI at different time points is reported. Correlation coefficient value range= -1 to 1. Higher positive value indicates greater positive relationship and higher negative value indicates greater negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||correlation coefficient|||Number
2622080|NCT01941940|Secondary|Association Between Disease Activity Parameters: DAS28-ESR and CDAI, Assessed Using Correlation Coefficient|DAS28-ESR is calculated from the TJC and SJC based on a 28-joint assessment, the ESR in mm/hour and PtGDA. DAS28-ESR total score= 0-9.4. Higher scores indicate greater affectation due to disease activity. The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. CDAI total score = 0-76. Higher scores represent greater affectation due to disease activity. Correlation coefficient for relationship between DAS28-ESR and CDAI at different time points is reported. Correlation coefficient value range= -1 to 1. Higher positive value indicates greater positive relationship and higher negative value indicates greater negative relationship.|Weeks 2, 24, 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||correlation coefficient|||Number
2622081|NCT01941940|Secondary|Change From Baseline in Total SJC at Weeks 2, 24, and 52|SJC was defined as the total number of swollen joints based on 66-joint assessment (SJC-66) and 28-joint assessment (SJC-28).|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||swollen joints||Standard Deviation|Mean
2622082|NCT01941940|Secondary|Change From Baseline in Total TJC at Weeks 2, 24, and 52|TJC was defined as the total number of painful joints based on 68-joint assessment (TJC-68) and 28-joint assessment (TJC-28).|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||tender joints||Standard Deviation|Mean
2622083|NCT01941940|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 </=3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to </=5.1 or change from baseline >0.6 to </=1.2 with DAS28 </=5.1; non-responders: change from baseline </=0.6 or change from baseline >0.6 and </=1.2 with DAS28 >5.1.|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||percentage of participants|||Number
2622084|NCT01941940|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response|The ACR 20, 50, and 70 responses: greater than or equal to (>/=) 20 percent (%), 50%, and 70% improvement in TJC and SJC (28 assessed joints), and 20%, 50%, 70% improvement in 3 of the following 5 criteria, respectively: 1) PGDA, 2) PtGDA, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP or ESR at each visit.|Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||percentage of participants|||Number
2622085|NCT01941940|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 24, and 52|SDAI is a numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS and C-reactive protein (CRP) in milligrams per deciliter (mg/dL). Higher scores indicate greater affectation due to disease activity. SDAI total score = 0-86. SDAI </=3.3 indicates disease remission, >3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity.|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||units on a scale||Standard Deviation|Mean
2622086|NCT01941940|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Weeks 2, 24, and 52|DAS28-ESR is calculated from the TJC and SJC based on a 28-joint assessment, the erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hour) and PtGDA assessed on 0-10 cm VAS. Higher scores indicate greater affectation due to disease activity. DAS28-ESR total score= 0-9.4. DAS28-ESR </=3.2 indicates low disease activity, DAS28-ESR >3.2 to 5.1 indicates moderate to high disease activity, and DAS28-ESR </=3.2 indicates remission.|Baseline, Weeks 2, 24, and 52|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||units on a scale||Standard Deviation|Mean
2622087|NCT01941940|Secondary|Number of Participants Achieving Clinical Remission According to CDAI up to Week 52|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 during any two consecutive visits, not including the baseline visit indicates disease remission.|Baseline up to Week 52 (Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 38, and 52)|FAS|||participants|||Number
2622125|NCT01941498|Secondary|Mean Total Laser Treatment Time|Total treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds. Total duration for both eyes was calculated as sum of duration for the right eye and left eye.|Day 0 (surgery)|This analysis group includes all participants with 1 month post-operative measurement of the primary efficacy endpoint.|||seconds||Standard Deviation|Mean
2622090|NCT01941940|Primary|Change From Baseline in CDAI at Week 8|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 8|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2622091|NCT01941940|Primary|Change From Baseline in CDAI at Week 12|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 12|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2622092|NCT01941940|Primary|Change From Baseline in CDAI at Week 16|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 16|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2622093|NCT01941940|Primary|Change From Baseline in CDAI at Week 20|The CDAI is a numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGDA and PGDA assessed on 0-10 cm VAS. Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score </=2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 20|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2622094|NCT01941940|Primary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|The CDAI is a numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient's global assessment of disease activity (PtGDA) and physician global assessment of disease activity (PGDA) assessed on 0-10 centimeters (cm) visual analogue scale (VAS). Higher scores represent greater affectation due to disease activity. CDAI total score = 0-76. CDAI score less than or equal to (</=) 2.8 indicates disease remission, greater than (>) 2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.|Baseline, Week 24|FAS; Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2622095|NCT01941927|Secondary|Number of Severe Adverse Events (Grade 3 and 4) Reported by Patients Related With the Treatment of Trametinib and GSK2141795.||Up to 2 years from beginning of therapy||||Severe Adverse Events|||Number
2622096|NCT01941927|Secondary|Time-to-Progression (TTP) of Patients Treated With the Combination of Trametinib and GSK 2141795|Time from treatment initiation until objective tumor progression observed. Only those participants who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. Participants who exhibit objective disease progression prior to the end of Cycle 1 will be considered evaluable. Response will also be considered inevaluable for any participants receiving treatment (regardless of how much was received) who did not have any follow-up assessment completed before initiation of alternative treatment or participants who die without documentation of disease progression and before it was time to conduct the first tumor reassessment, will be considered inevaluable or not assessed adequately|Up to 2 years from beginning of therapy|The drug combination failed to produce objective responses in participants with either NRAS mutant or NRAS wild-type melanoma in TTP evaluable patient population. No objective responses for progression in TTP specific evaluable participants population were observed so endpoint could not be calculated.||||||
2622097|NCT01941927|Secondary|Overall Survival of Patients Treated With the Combination of Trametinib and GSK 2141795||Up to 2 years from beginning of therapy||||months||95% Confidence Interval|Median
2622098|NCT01941927|Secondary|Progression-Free Survival of Patients Treated With the Combination of Trametinib and GSK 2141795|Time from randomization to objective tumor progression or death. Participants who die without documentation of disease progression and before it was time to conduct the first tumor reassessment, will be considered inevaluable or not assessed adequately|Up to 2 years from beginning of therapy||||months||95% Confidence Interval|Median
2622099|NCT01941927|Primary|Objective Response Rate (ORR)|Only those participants who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response These participants will have their response classified according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) method, where the baseline target lesion sum of longest diameter (LD) will be used as reference by which to characterize the objective tumor response. An objective response is defined as an overall response of complete response (CR), partial response (PR), or stable disease (SD) with a confirmatory scan or evaluation at time of final disease response determination.|Up to 2 years from beginning of therapy|Reported here are a number of participants that achieved the best objective response defined as stable disease|||Participants|||Count of Participants
2622100|NCT01941745|Secondary|Short Term Efficacy - Number of Neonates With Oxygen Requirement at 36 Weeks Post Menstrual Age|Short term efficacy evaluations involve number of neonates with oxygen requirement at 36 weeks post menstrual age.|36 weeks post-menstrual age|Subjects were recruited from Tufts Medical Center, Brigham and Women's Hospital, Baystate Medical Center, Ginekologiczno-Położniczy Szpital Kliniczny UM, Instytut Centrum Zdrowia Matki Polski and Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie (USA, Poland).|||Participants|||Count of Participants
2622126|NCT01941498|Secondary|Mean Laser Treatment Time|Treatment time with Excimer EX500 and Femtosecond FS200 lasers, measured in seconds.|Day 0 (surgery)|This analysis group includes all participants with 1 month post-operative measurement of the primary efficacy endpoint.|||seconds||Standard Deviation|Mean
2622101|NCT01941745|Secondary|Safety and Efficacy - Number of Participants With Adverse Events|The safety of the study drug was assessed by accounting the number of participants with Adverse Events (AEs) in the treatment and placebo groups.|Adverse events are monitored through 36 wks post-menstrual age (PMA)|Subjects were recruited from Tufts Medical Center, Brigham and Women's Hospital, Baystate Medical Center, Ginekologiczno-Położniczy Szpital Kliniczny UM, Instytut Centrum Zdrowia Matki Polski and Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie (USA, Poland).|||Participants|||Count of Participants
2622102|NCT01941745|Secondary|Long Term Efficacy - Survival Without Evidence of Chronic Pulmonary Insufficiency of Prematurity (CPIP) at 6 Months Corrected Gestational Age (CGA)|"Number of events of survived participants, graded as not having 1, 2, 3, or 4 of the CPIP components defined below:~Medical/ER visits (CPIP-DV): ≥1 non-routine medical visit(s) for respiratory causes.~Respiratory re-hospitalizations (CPIP-RH): ≥1 re-hospitalization(s) for respiratory causes Respiratory Symptoms (CPIP-SS): Parent-reported evidence of respiratory symptoms (e.g. coughing and wheezing) or use of respiratory medications Respiratory Medications (CPIP-RM): Administration of respiratory medications (including oxygen)~A participant graded without 4 CPIP components is considered in better health than a participant graded without 1 CPIP component. CPIP components were parent-validated via respiratory diaries (wheezing, coughing, and/or respiratory medication use ≥2 days/wk for 3 consecutive wks), and pulmonary questionnaires (decrease in respiratory illness requiring medications, unscheduled medical visits and/or ER or hospital admissions)."|6 months Corrected Gestational Age|Subjects were recruited from Tufts Medical Center, Brigham and Women's Hospital, Baystate Medical Center, Ginekologiczno-Położniczy Szpital Kliniczny UM, Instytut Centrum Zdrowia Matki Polski and Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie (USA, Poland).|||Number of Events|||Number
2622103|NCT01941745|Primary|Survival Without Evidence of Chronic Pulmonary Insufficiency of Prematurity (CPIP) at 12 Months Corrected Gestational Age (CGA)|"Number of events of survived participants without one or more of the CPIP components defined below:~Medical/ER visits (CPIP-DV): At least one non-routine medical visit for respiratory causes.~Respiratory re-hospitalizations (CPIP-RH): One or more re-hospitalizations for respiratory causes.~Respiratory Symptoms (CPIP-SS): Evidence of respiratory symptoms (e.g. coughing and wheezing) or use of respiratory medications by parental diaries or pulmonary questionnaires.~Respiratory Medications (CPIP-RM): Administration of respiratory medications (including oxygen).~CPIP is defined as the presence of one or more parent-reported outcomes at 12 months CGA, validated by Respiratory diaries (presence of wheezing, coughing, and/or respiratory medication use ≥2 days per week for 3 consecutive weeks), and Pulmonary questionnaires (decrease in respiratory illness requiring medications, unscheduled medical visits and/or ER or hospital admissions)."|12 Months Corrected Gestational Age (*no imputation for missing data)|Subjects were recruited from Tufts Medical Center, Brigham and Women's Hospital, Baystate Medical Center, Ginekologiczno-Położniczy Szpital Kliniczny Uniwersytetu Medycznego (UM), Instytut Centrum Zdrowia Matki Polski and Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie (USA, Poland).|||Number of events|Number of events||Number
2622104|NCT01941628|Secondary|Peroperative and Postoperative Surgical Complication|A total number of surgical complications evaluated at day 5 after Caesarean delivery.|5 days||||participants|||Number
2622105|NCT01941628|Primary|Number of Participants With Newborn in Need of Respiratory Support|The number of participants with a newborn in need of respiratory support will be the primary safety measure in comparison of the influence of different neuromuscular blockade levels on newborn adaptation.|24 hours|The number of participants with a newborn in need of respiratory support|||participants|||Number
2622106|NCT01941628|Primary|Induction to Delivery Interval|Induction to delivery interval will be used as primary keypoint for surgical conditions comparison.|24 hrs||||seconds||Standard Deviation|Mean
2622107|NCT01941615|Primary|C24,ss of Levonogestrel|Measured concentration of levonogestrel in plasma at steady state 24 hours after drug administration.|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.||||||
2622108|NCT01941615|Primary|Cmax,ss of Levonogestrel|Maximum measured concentration of levonogestrel in plasma at steady state over a uniform dosing interval t.|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.||||||
2622109|NCT01941615|Primary|AUCtau,ss of Levonogestrel|Area under the concentration-time curve of levonogestrel in plasma at steady state over a uniform dosing interval t.|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.||||||
2622110|NCT01941615|Primary|C24,ss of Ethinylestradiol|Measured concentration of ethinylestradiol in plasma at steady state 24 hours after drug administration.|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.||||||
2622111|NCT01941615|Primary|Cmax,ss of Ethinylestradiol|Maximum measured concentration of ethinylestradiol in plasma at steady state over a uniform dosing interval t|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.||||||
2622112|NCT01941615|Primary|AUCtau,ss of Ethinylestradiol|Area under the concentration-time curve of ethinylestradiol in plasma at steady state over a uniform dosing interval t (AUCtau,ss).|Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives|Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined.||||||
2622113|NCT01941537|Secondary|Change in IGA Score|"Change in Investigator Global Assessment score (IGA) at week 12 as compared to baseline for both arms of the study in subjects with atopic dermatitis.~IGA is a score between 0-5, with 0 being all clear, 1 being almost clear, 2 being mild disease, 3 being moderate disease, 4 being severe disease and 5 being very severe disease."|12 weeks||||score on a scale||Standard Error|Mean
2622114|NCT01941537|Secondary|The (Per-patient) Percent Improvement in the SCORAD Relative to Baseline.|The (per-patient) percent improvement in the SCORAD relative to baseline, which will be analyzed using the MMRM approach described for the primary efficacy endpoint. Improvement is measured as the reduction in the score.|12 weeks||||percentage decline in SCORAD score||Standard Error|Mean
2622115|NCT01941537|Secondary|The Percentage of Patients Who Achieve an Improvement of 50% or Greater From Their Baseline Objective SCORAD at Week 12 of ILV-094 Treatment|The SCORAD50 captures individuals who achieved 50% or greater improvement from baseline SCORAD score. This outcome measure is the percentage of participants who achieved SCORAD50 at week 12. This analysis will be performed using fisher exact test. Patients who drop-out will be considered treatment failures (non-responder approach). A sensitivity analysis will be carried out using data as observed.|12 weeks||||percentage of participants|||Number
2622116|NCT01941537|Primary|Percentage Change in SCORAD|"Percentage Change in the Scoring of Atopic Dermatitis (SCORAD) at week 12 compared to baseline in both arms of the study in subjects with atopic dermatitis.~SCORAD (Severity scoring of Atopic Dermatitis) is composite severity index comprising a) the amount/extent of body surface area affected, b) subjective symptom visual analog assessments [itchy 0 (no itching) to 3 (severe itching) and sleep disturbance 0(no sleep disturbance) to 3 (severe sleep disturbance)], and c) 6 disease intensity assessments [dryness/scaling, erythema, induration/papulation, excoriation, lichenification and oozing/weeping/crusting, each graded from 0 to (none) to 3 (severe). A SCORAD score ranges from 0 (no AD present) to 103 (severe)."|12 weeks||||percentage change||Standard Error|Mean
2622117|NCT01941498|Secondary|Corneal Curvature as Measured by Keratometry|Corneal curvature was assessed by a commercially available system and measured in diopters.|Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||diopter||Standard Deviation|Mean
2622118|NCT01941498|Secondary|Wavefront Aberrometry|Wavefront aberrations (optical imperfections of the eye that prevent light from focusing perfectly on the retina, resulting in defects in the visual image) were measured using a commercially available system. Higher order aberrations (i.e., spherical aberrations, coma, and trifoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology.|Baseline (Day 0), Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint.|||microns||Standard Deviation|Mean
2622119|NCT01941498|Secondary|Mean Contrast Sensitivity (CS)|Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd), where 3.0 cpd = A, 6.0 cpd = B, 12.0 cpd = C, and 18.0 cpd = D. Raw scores were log transformed. A higher numeric value represents better contrast sensitivity.|Baseline (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative|"This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint. Here, n is the number of subjects assessed uncorrected."|||logCS||Standard Deviation|Mean
2622120|NCT01941498|Secondary|"Percent Response by Category: Driving at Night"|"As recorded by the subject on the RSVP questionnaire, where 0 is Not applicable, 1 is No difficulty at all, 2 is A little difficulty, 3 is Moderate difficulty, 4 is Severe difficulty and 5 is So much difficulty that I did not do the activity with this alternative."|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||percentage of subjects|||Number
2622121|NCT01941498|Secondary|"Percent Response by Category: My Vision Is a Concern in My Daily Life"|As recorded by the subject on the RSVP questionnaire|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||percentage of subjects|||Number
2622122|NCT01941498|Secondary|"Percent Response by Category: I Worry About my Vision"|As recorded by the subject on the RSVP questionnaire|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||percentage of subjects|||Number
2622123|NCT01941498|Secondary|"Percent Response by Category: In the Past 4 Weeks, to See Far Away, I Wore..."|As recorded by the subject on the RSVP questionnaire, where n/a means no use of glasses or contact lenses.|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||percentage of subjects|||Number
2622124|NCT01941498|Secondary|"Mean Response: Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses"|As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error, on a scale from 0 (completely blind) to 10 (perfect vision).|Baseline (Day 0), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||units on a scale||Standard Deviation|Mean
2622127|NCT01941498|Secondary|Mean Manifest Refraction (Cylinder)|Manifest refraction was performed under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. Each eye individually contributed to the mean.|Baseline (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||diopter|Participants|Standard Deviation|Mean
2622128|NCT01941498|Secondary|Mean Manifest Refraction (Sphere)|Manifest refraction was performed under photopic lighting conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. Each eye individually contributed to the mean.|Baseline (Day 0), Operation/Surgery (Day 1), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||diopter|Participants|Standard Deviation|Mean
2622129|NCT01941498|Secondary|Mean Difference Between Achieved and Target Corneal Flap Thickness as Assessed by OCT|The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness as assessed by optical coherence tomography (OCT) (ie, an imaging method using light to capture three-dimensional images). A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number.|Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||microns||Standard Deviation|Mean
2622130|NCT01941498|Primary|Least Squares Mean Difference in Binocular UCVA at 1 Month Post-Treatment and Pre-Treatment Binocular BCVA|Visual acuity (VA) with corrective devices (BCVA) was assessed binocularly (both eyes together) pre-treatment and subtracted from VA without spectacles or other visual corrective devices (UCVA) assessed binocularly at 1 month post-treatment. VA was measured at a distance of 4 meters and reported in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A negative value indicates an improvement in VA from pre-treatment to Month 1.|Month 1|This analysis population includes all participants with 1 month post-operative measurement of the primary efficacy endpoint.|||logMAR||Standard Error|Least Squares Mean
2622131|NCT01941485|Secondary|Corneal Topography: Angles|The angles (angular measurement of the space between the iris and the lens) were assessed using a commercially available system. The higher the value, the bigger the space.|Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|"This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data."|||degrees|Eyes|Standard Deviation|Mean
2622132|NCT01941485|Secondary|Corneal Topography: Anterior Chamber (AC) Depth|The AC depth (axial distance between the anterior surface of the cornea and the anterior surface of the lens) was assessed using a commercially available system. A higher value represents a longer distance.|Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|"This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data."|||millimeters|Eyes|Standard Deviation|Mean
2622133|NCT01941485|Secondary|Corneal Topography: Anterior Chamber (AC) Volume|The AC volume (a measure of the shallowness of the anterior chamber) was assessed using a commercially available system. The lower the chamber volume, the more shallow the anterior chamber or the chamber angle.|Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|"This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data."|||millimeters cubed|Eyes|Standard Deviation|Mean
2622134|NCT01941485|Secondary|Corneal Topography: Q-value|The Q-value (a measure of corneal asphericity) was assessed using a commercially available system. The Q-values are negative (−1 < Q < 0) for prolate corneas, in which the central curvature is steeper than the peripheral curvature, and positive (Q > 0) for oblate corneas, in which the central curvature is flatter than the peripheral curvature.|Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|"This analysis population includes all subjects with 1 day post-operation measurements of the corneal topography endpoint. Here, n includes all eyes with data."|||unit less|Eyes|Standard Deviation|Mean
2622135|NCT01941485|Secondary|Flap Creation Time as Documented in the Log Files|The time to create the flap with FS200 Femtosecond Flap Creation System, measured in seconds.|Operation/Surgery (Day 1)|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||seconds||Standard Deviation|Mean
2622136|NCT01941485|Secondary|Corneal Curvature as Measured by Keratometry|Corneal curvature as assessed by a commercially available system and measured in diopters.|Baseline/Screening (Day 0), 1 Month Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||diopter||Standard Deviation|Mean
2622137|NCT01941485|Secondary|"Percent Response by Category: Driving at Night"|"As recorded by the subject on the RSVP questionnaire, where 0 is Not applicable, 1 is No difficulty at all, 2 is A little difficulty, 3 is Moderate difficulty, 4 is Severe difficulty and 5 is So much difficulty that I did not do the activity with this alternative."|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||percentage of subjects|||Number
2622138|NCT01941485|Secondary|"Percent Response by Category: My Vision is a Concern in my Daily Life"|As recorded by the subject on the RSVP questionnaire|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||percentage of subjects|||Number
2622139|NCT01941485|Secondary|"Percent Response by Category: I Worry About my Vision"|As recorded by the subject on the RSVP questionnaire|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||percentage of subjects|||Number
2622140|NCT01941485|Secondary|"Percent Response to Have Always Worn Glasses or Contact Lenses in the Past 4 Weeks"|As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error.|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint.|||percentage of subjects|||Number
2622141|NCT01941485|Secondary|"Mean Response: Rate Your Vision, Over the Past 4 Weeks, With NO Glasses or Contact Lenses"|As recorded by the subject on the the Refractive Status and Vision Profile (RSVP), a self-reported questionnaire used to measure vision-related health status in persons with refractive error, on a scale from 0 (completely blind) to 10 (perfect vision).|Baseline/Screening (Day 0), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||units on a scale||Standard Deviation|Mean
2622142|NCT01941485|Secondary|Wavefront Aberrometry|Wavefront aberrations (optical imperfections of the eye that prevent light from focusing perfectly on the retina, resulting in defects in the visual image) were measured using a commercially available system. Higher order aberrations (i.e., spherical aberrations, coma, and trefoil) are defined as optical imperfections which cannot be corrected by any reliable means of present technology.|Operation/Surgery (Day 1), Month 1 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||micrometers||Standard Deviation|Mean
2622143|NCT01941485|Secondary|Corneal Flap Diameter as Assessed by Ocular Coherence Tomography (OCT)|The diameter of the corneal flap was assessed by OCT (ie. an imaging method using light to capture three-dimensional images). Corneal flap is measured in millimeters.|Operation/Surgery (Day 1), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||millimeters||Standard Deviation|Mean
2622144|NCT01941485|Secondary|Mean Contrast Sensitivity (CS)|Contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with distance manifest correction in place and uncorrected. Contrast sensitivity was assessed at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd), where 3.0 cpd = A, 6.0 cpd = B, 12.0 cpd = C, and 18.0 cpd = D. Raw scores were log transformed. A higher numeric value represents better contrast sensitivity. Both eyes contributed to the analysis.|Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||logCS||Standard Deviation|Mean
2622145|NCT01941485|Secondary|Manifest Refraction (Cylinder)|A series of test lenses in graded powers was used to determine which corrective lenses provided the sharpest, clearest vision. Manifest refraction is measured in diopters. Each eye contributed individually to the analysis.|Baseline/Screening (Day 0), Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||Diopters|eyes|Standard Deviation|Mean
2622146|NCT01941485|Secondary|Manifest Refraction (Sphere)|A series of test lenses in graded powers was used to determine which corrective lenses provided the sharpest, clearest vision. Manifest refraction is measured in diopters. Each eye contributed individually to the analysis.|Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||Diopters|Eyes|Standard Deviation|Mean
2622147|NCT01941485|Secondary|Best Corrected Visual Acuity (BCVA)|VA with the subjects's best spectacles or other visual corrective devices, was performed with an ETDRS chart set at a distance of 4 meters. BCVA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity.|Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||logMAR||Standard Deviation|Mean
2622148|NCT01941485|Secondary|Uncorrected Visual Acuity (UCVA)|Visual acuity (VA) without spectacles or other visual corrective devices, was performed with an Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at a distance of 4 meters. UCVA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.00 logMAR corresponding to 20/20 Snellen. A lower logMAR value indicates better visual acuity.|Baseline/Screening (Day 0), Day 1 Postoperative, Month 1 Postoperative, Month 3 Postoperative, Month 6 Postoperative, Month 12 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||logMAR||Standard Deviation|Mean
2622149|NCT01941485|Secondary|The Difference Between Achieved Flap Thickness at Month 1 Post-operative as Assessed by OCT and Expected Flap Thickness as Determined Preoperatively|The expected flap thickness as determined pre-operatively subtracted from the achieved flap thickness at Month 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images). Accuracy of flap creation was defined as an achieved thickness within 10 microns of expected thickness.|Month 1 Postoperative|This analysis population includes all subjects with 1 month post-operative measurements of the primary efficacy endpoint with data at the specific time point.|||microns||Standard Deviation|Mean
2622150|NCT01941485|Secondary|Extent of Opaque Bubble Layer (OBL) Within the Femtosecond Flap|The extent of OBL was assessed by digital photo analysis of the area covered by the flap and is reported as the percentage of flap with opaque bubble layer development during femtosecond flap creation.|Operation/Surgery (Day 1)|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||percentage of flap||Standard Deviation|Mean
2622181|NCT01941030|Primary|Change in Fibrous Plaque Area as Assessed by IVUS|The pre- (Pre-Tx) and post-treatment (Post-Tx) fibrous plaque area. A positive value equates to a decrease in fibrous plaque area.|Pre-intervention, and post-balloon angioplasty|Not all subjects had reported IVUS data for each lesion pre- and post-treatment.|||area (mm^3/mm)|lesions|Inter-Quartile Range|Median
2622151|NCT01941485|Secondary|Incidence of Development of Opaque Bubble Layer (OBL)|OBL (the collection of gas bubbles during corneal flap creation) was assessed by digital photo analysis of the area covered by the flap and is reported as the percentage of participants with opaque bubble layer development during femtosecond flap creation.|Operation/Surgery (Day 1)|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||percentage of participants|||Number
2622152|NCT01941485|Primary|The Difference Between Achieved Flap Thickness at Day 1 Postoperative as Assessed by OCT and Expected Flap Thickness as Determined Pre-operatively|The expected flap thickness as determined pre-operatively was subtracted from the achieved flap thickness at Day 1 postoperative as assessed by optical coherence tomography (ie, an imaging method using light to capture three-dimensional images). Accuracy of flap creation was defined as an achieved thickness within 10 microns of expected thickness.|Day 1 Postoperative|This analysis population includes all subjects with 1 day post-operation measurements of the primary effectiveness endpoint.|||microns||Standard Deviation|Mean
2622153|NCT01941472|Primary|Fluid Responsiveness|Increase in cardiac index ≥ 10% after fluid challenge|Immediately after fluid challenge, average 5 minutes||||Participants|||Count of Participants
2622154|NCT01941186|Other Pre-specified|Acceptability of the Patient Decision Aid for Early Intervention Referral|The acceptability of using the patient decision aid for early intervention will be assessed by having patients and providers complete surveys on the intervention.|Up to 7 days|"Provider information was not collected as outlined in the initial protocol design. All survey data is presented collectively in Secondary Outcome Measure, Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention. This includes elements of parent acceptability. A separate analysis was not completed."||||||
2622155|NCT01941186|Other Pre-specified|Feasibility of the Patient Decision Aid|The feasibility of the patient decision aid (PDA) will be measured by calculating the number of individuals who refuse to participate, time that it takes to complete the PDA, and the number of patients who complete the Early Intervention referral.|Up to 7 days|Data was not collected regarding the time to complete PDA and/or number of Early Intervention referrals for the total population, thus data for this outcome measure was not able to be analyzed as outlined at the time of protocol development.||||||
2622156|NCT01941186|Other Pre-specified|Parental Predisposition for Early Intervention|Parental predisposition for early intervention services will be measured using surveys.|Up to 7 days|"All survey data is presented collectively in Secondary Outcome Measure, Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention. A separate analysis was not completed."||||||
2622157|NCT01941186|Other Pre-specified|Parent Uncertainty About Early Intervention|Parental uncertainty about whether to enroll their child in Early Intervention will be evaluated using a survey.|Up to 7 days|"All survey data is presented collectively in Secondary Outcome Measure, Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention. A separate analysis was not completed."||||||
2622158|NCT01941186|Secondary|Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention|Pre and post knowledge and attitudes regarding developmental delay and early intervention (EI) were assessed by asking participants to respond to 14 statements using a 6 point Likert scale that ranged from strongly disagree to strongly agree. Questions mapped to the video decision aid content viewed by participants. Participants in the intervention arm completed the questions before and after watching the video and participants in the control arm completed the questions sequentially. Secondary outcome measures assessed in the survey included Parent Uncertainty About Early Intervention and Parental Predisposition for Early Intervention.|Up to 7 days|All parent-child dyads who were enrolled and randomized were included in the analysis.|||percentage of participants|||Number
2622159|NCT01941186|Primary|Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups|Completed intake and evaluation by the early intervention (EI) agency was assessed by parent report and by chart review. A member of the study team contacted parents within 6 months of the first study visit to obtain this information. Additionally, a chart review seeking written feedback information regarding referral disposition from the EI agency was completed.|Up to 1 year after randomization|One parent-child dyad had missing information regarding EI intake and evaluation. Given the absence of information on referral outcome, this parent-child dyad was included in the final evaluation as having not received an EI intake and evaluation.|||participants|||Number
2622160|NCT01941095|Secondary|Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score|FACIT-Fatigue total score is sum of FACIT-General subscale score and FACIT-Fatigue (additional concerns) subscale score. FACT-General consists of 27 questions grouped in 4 domains of general health-related quality of life: physical well-being, social/family well-being, emotional well-being, and functional well-being; each item ranges from 0 (not at all) to 4 (very much). FACT-General score ranges between 0-108. FACIT-Fatigue subscale is a 13-item questionnaire that evaluates self-reported fatigue and its impact upon daily activities. Each item ranges from 0 (Not at all) to 4 (Very much). For all items, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue subscale score for a total possible score of 0 (worse score) to 52 (better score). FACIT-Fatigue total score (FACT-G plus FACT-F subscale scores) ranges from 0 (better score) to 160 (worse score).|Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Full analysis set. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
2622161|NCT01941095|Secondary|Percentage of Participants Who Received All Planned Study Medication (Compliance)|Compliance (in terms of percentage of participants who received all planned study medication) was assessed on the basis of participant diary cards and return records.|Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Full analysis set. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.|||percentage of participants|||Number
2622182|NCT01941030|Primary|Change in Necrotic Core Area as Assessed by IVUS|The pre- (Pre-Tx) and post-treatment (Post-Tx) necrotic core area. A positive value equates to a decrease necrotic core area.|Pre-intervention, and post-balloon angioplasty|Not all subjects had reported IVUS data for each lesion pre- and post-treatment.|||area (mm^3/mm)|lesions|Inter-Quartile Range|Median
2625220|NCT01914757|Secondary|Time to First Asthma Exacerbation||Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Participants|||Number
2622162|NCT01941095|Secondary|HAQ-DI Score|"The Stanford HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Responses in each component set were scored from 0 (without any difficulty) to 3 (unable to do). The highest score recorded for any question in a category determines the score for the category, unless aids, devices, or help from another person was required. The HAQ-DI score was calculated as the sum of the category scores divided by the number of categories scored, giving a possible range of scores from 0 to 3. Scores of 0 to 1 are generally considered to represent mild to moderate difficulty, 1 to 2 as moderate to severe disability, and 2 to 3 as severe to very severe disability."|Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Full analysis set. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
2622163|NCT01941095|Secondary|Patient Assessment of Pain, Using VAS Score|"The participant's level of pain was assessed on a 0 to 100 mm horizontal VAS. The extreme left end of the line = 0 mm, and was described as no pain and the extreme right end = 100 mm, and was described as unbearable pain. Higher values correspond to worst state of participant (higher level of pain)."|Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Full analysis set. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.|||mm||Standard Deviation|Mean
2622164|NCT01941095|Secondary|PGA, Using VAS Score|"PGA was assessed on a 0 to 100 mm horizontal VAS. The extreme left end of the line = 0 mm, and was described as no disease activity (symptom-free and no arthritis symptoms) and the extreme right end = 100 mm, and was described as maximum disease activity (maximum arthritis disease activity). Higher values correspond to worst state of participant (high disease activity)."|Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Full analysis set. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.|||mm||Standard Deviation|Mean
2622165|NCT01941095|Secondary|Tocilizumab Serum Levels||Baseline (Week 1), Weeks 12, 24, 36, 52, and 8 weeks after Week 52 dose (Week 60)|Full analysis set. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.|||microgrms per milliliter (mcg/mL)||Standard Deviation|Mean
2622166|NCT01941095|Secondary|Soluble Interleukin-6 Receptor (sIL-6R) Levels||Baseline (Week 1), Weeks 12, 24, 36, 52, and 8 weeks after Week 52 dose (Week 60)|Full analysis set. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2622167|NCT01941095|Secondary|Number of Participants With Anti-Tocilizumab Antibodies (ATA)|All samples were tested using a screening assay and, if positive, by a confirmation assay to determine specificity and a neutralizing assay to test for the ability to inhibit the activity of tocilizumab. Number of participants with a positive assay result for screening assay (ATA - Screen), confirmatory assay (ATA - Confirmatory), and neutralizing assay (ATA - Neutralizing) was reported separately.|Baseline (Week 1), Weeks 12, 24, 36, 52, and 8 weeks after Week 52 dose (Week 60)|Full analysis set. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.|||participants|||Number
2622168|NCT01941095|Secondary|Number of Participants by Reasons (Categories) for Corticosteroid Dose Reduction or Discontinuation|Reasons for corticosteroid dose reduction included: Safety Reasons (including elevated liver function test results, respiratory infections, infections and infestations, gastrointestinal disorders etc.); Other Reasons (disease remission, improvement etc.); and Unknown Reasons (including no reason). Number of participants by reasons (Safety, Other, Unknown) for corticosteroid dose reduction or discontinuation were reported.|From Baseline up to Week 52|Full analysis set. Overall number of participants analyzed = participants with corticosteroid dose reduction/discontinuation.|||participants|||Number
2622169|NCT01941095|Secondary|Percentage of Participants With Corticosteroid Dose Reduction or Discontinuation||From Baseline up to Week 52|Full analysis set. Overall number of participants analyzed = participants who used corticosteroids during the study.|||percentage of participants|||Number
2622170|NCT01941095|Secondary|Change From Baseline in SJC28 up to Week 52|28 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28. A negative change from baseline indicated improvement.|Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Full analysis set. Overall number of participants analyzed = participants evaluable for this outcome measure. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.|||swollen joints||95% Confidence Interval|Mean
2622171|NCT01941095|Secondary|Change From Baseline in TJC28 up to Week 52|28 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28. A negative change from baseline indicated improvement.|Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Full analysis set. Overall number of participants analyzed = participants evaluable for this outcome measure. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.|||tender joints||95% Confidence Interval|Mean
2622172|NCT01941095|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score up to Week 52|SDAI is an index for measuring disease activity. SDAI is the numerical sum of five outcome parameters: TJC28 and SJC28, PGA and physician global assessment of disease activity assessed on VAS (0 centimeter [cm]-10 cm); 0 cm= no disease activity and 10 cm= worst disease activity, and CRP (in milligrams per deciliter [mg/dL]). SDAI total score ranges from 0 to 86, with higher scores indicating increased (or severe) disease activity. SDAI score </=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Full analysis set. Overall number of participants analyzed = participants evaluable for this outcome measure. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.|||units on a scale||95% Confidence Interval|Mean
2622183|NCT01941030|Primary|Change in Dense Calcium Area as Assessed by IVUS|The pre- (Pre-Tx) and post-treatment (Post-Tx) dense calcium area. A positive value equates to a decrease in dense calcium area.|Pre-intervention, and post-balloon angioplasty|Not all subjects had reported IVUS data for each lesion pre- and post-treatment.|||area (mm^3/mm)|lesions|Inter-Quartile Range|Median
2622173|NCT01941095|Secondary|Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria|Response to treatment was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from the baseline visit. Participants with a score lesser than or equal to (</=) 3.2 and reduction of greater than (>) 1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score </=5.1 with reduction of >0.6 to </=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to </=1.2 points, or any score with reduction </=0.6 points, were assessed as having 'no response'.|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Full analysis set. Overall number of participants analyzed = participants evaluable for this outcome measure. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.|||percentage of participants|||Number
2622174|NCT01941095|Secondary|Number of Participants With American College of Rheumatology 20 (ACR20) Response|ACR20 response was defined as >/=20% improvement from baseline in both TJC28 and SJC28 as well as in 3 out of 5 additional parameters: Separate patient and physician's global assessment of disease activity on VAS (0 mm=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS), patient's assessment of pain on VAS (0 mm=no pain to 100 mm=unbearable pain, displayed on the 100 mm horizontal VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI) (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without any difficulty to 3=unable to do), and acute phase response (ESR in mm/hr, for a total possible score of 0 to 10).|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Full analysis set. Overall number of participants analyzed = participants evaluable for this outcome measure. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.|||participants|||Number
2622175|NCT01941095|Secondary|Change From Baseline in DAS28-ESR up to Week 52|DAS28-ESR score is a measure of participant's disease activity calculated using TJC28, SJC28, PGA using VAS 0 mm=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (ESR in mm/hr) for a total possible score of 0 to 10. The score is calculated using the following formula: DAS28-ESR = [0.56 * √TJC28 + [0.28*√SJC28]+[0.70*ln ESR]+[0.014*GH]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity. A negative change from baseline indicates an improvement.|Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Full analysis set. Overall number of participants analyzed = participants evaluable for this outcome measure. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.|||units on a scale||95% Confidence Interval|Mean
2622176|NCT01941095|Secondary|Percentage of Participants Who Achieved DAS28-ESR Remission/Low Disease Activity (LDA) From Week 28 up to Week 52 Among Participants With Intensification of Methotrexate/Other Non-Biologic DMARDs in Combination With Tocilizumab Since Week 24|DAS28-ESR score is a measure of participant's disease activity calculated using TJC28, SJC28, PGA using VAS 0 mm=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (ESR in mm/hr) for a total possible score of 0 to 10. The score is calculated using the following formula: DAS28-ESR = [0.56 * √TJC28 + [0.28*√SJC28]+[0.70*ln ESR]+[0.014*GH]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity. DAS28-ESR score <2.6 represents DAS28-ESR remission. DAS28-ESR score greater than or equal to (>/=) 2.6 and <3.2 represents LDA.|Weeks 28, 32, 36, 40, 44, 48, 52|Full analysis set. Overall number of participants analyzed = participants evaluable for this outcome measure. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.|||percentage of participants|||Number
2622177|NCT01941095|Secondary|Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24|DAS28-ESR score is a measure of participant's disease activity calculated using TJC28, SJC28, PGA using VAS 0 mm=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (ESR in mm/hr) for a total possible score of 0 to 10. The score is calculated using the following formula: DAS28-ESR = [0.56 * √TJC28 + [0.28*√SJC28]+[0.70*ln ESR]+[0.014*GH]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity. DAS28-ESR score <2.6 represents DAS28-ESR remission. The percentage reported for Week 24 is based on confirmation on switching to SC tocilizumab monotherapy.|Weeks 24, 28, 32, 36, 40, 44, 48, 52|Per protocol analysis. Overall number of participants analyzed = participants evaluable for this outcome measure. Here, Number analyzed = number of participants analyzed for this outcome measure at specified timepoint.|||percentage of participants|||Number
2622178|NCT01941095|Primary|Percentage of Participants Who Achieved Disease Activity Score Based on 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at Week 24|DAS28-ESR score is a measure of participant's disease activity calculated using tender joint count in 28 joints (TJC28), swollen joint count in 28 joints (SJC28), patient global assessment of disease activity (PGA) (general health [GH]) using visual analog scale (VAS): 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (ESR in millimeters per hour [mm/hr]). The score is calculated using the following formula: DAS28-ESR = [0.56 multiplied by (*) square root (√) of TJC28] plus (+) [0.28*√SJC28]+[0.70*the natural logarithm (ln) ESR]+[0.014*GH]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity. DAS28-ESR score of less than (<) 2.6 represents DAS28-ESR remission.|Week 24|Full analysis set. Overall number of participants analyzed = participants evaluable for this outcome measure.|||percentage of participants|||Number
2622179|NCT01941030|Secondary|Fractional Flow Reserve|Fractional flow reserve (FFR) will be measured to assess hemodynamic function following each device procedure. During FFR, adenosine will be given through the femoral artery sheath or access catheter in two doses: 600 mcg and 1200 mcg. A higher FFR is presumed to correlate to better flow which may improve wound healing.|Post-orbital atherectomy (OA arm only) and post-balloon angioplasty (both arms)|Some sites were exempt from performing FFR. Not all subjects had available FFR.|||Ratio (proximal/distal pressure)|lesions|Standard Deviation|Mean
2622180|NCT01941030|Primary|Change in Fibrofatty Plaque Area as Assessed by IVUS|The pre- (Pre-Tx) and post-treatment (Post-Tx) fibrofatty plaque area. A positive value equates to a decrease in fibrofatty plaque area.|Pre-intervention, and post-balloon angioplasty|Not all subjects had reported IVUS data for each lesion pre- and post-treatment.|||area (mm^3/mm)|lesions|Inter-Quartile Range|Median
2622186|NCT01941030|Primary|Percentage of Calcium Removal Out of Lumen Gain as Assessed by IVUS|The post-treatment percentage of calcium removal out of lumen gain at the maximum calcium ablation site. A positive value equates to reduction in calcium out of the lumen gain.|Post-balloon angioplasty|Not all subjects had reported IVUS data for each lesion pre- and post-treatment.|||percentage of lumen gain|lesions|Inter-Quartile Range|Median
2622187|NCT01940939|Other Pre-specified|Event-related Spectral Perturbation (ERSP)|Alterations in gamma-band ASSR have been thought to be the most robust finding of abnormal neural oscillations in patients with schizophrenia. EEG data were acquired using a 64-electrode cap and alternating current BrainAmp amplifiers (Brain Products GmbH, Germany). We used EEGLAB to perform time-frequency analysis with a short-term Fourier transformation, and then calculated ERSP.|4 weeks|patients discontinualed treatment|||dB||Full Range|Mean
2622188|NCT01940939|Secondary|MATRICS Consensus Cognitive Battery (MCCB) in Chinese Version|MCCB in Chinese Version includes 9 tasks across 7 domains, and a composite score, including Processing Speed (Brief Assessment of Cognition in Schizophrenia Symbol Coding, Animal Fluency, Trails A), Attention (Continuous Performance Test), Working Memory (WMS-III Spatial Span), Verbal Learning (Hopkins Verbal Learning Test - Revised), Visual Learning (Brief Visuospatial Memory Test - Revised), Problem Solving (Neuropsychological Assessment Battery), and Social Cognition (Mayer-Salovey- Caruso Emotional Intelligence Test).The results are reported as T scores with a mean of 50 and an SD of 10.|Baseline and 4 weeks|Ten patients dropped out due to different reasons (three patients refused to participated, three did not complianted and the other four were discharged before completion of study)|||MCCB(T score)||Standard Deviation|Mean
2622189|NCT01940939|Primary|The Change in the Severity of Negative Symptoms|The assessment of negative symptoms were measured with the Positive and Negative Symptom Scale (PANSS) and the Scale for the Assessment of Negative Symptoms (SANS).The SANS contains 30 particular items divided into 5 symptomatological domains: 1) affective flattening and/or blunting, 2) alogia, 3) avolition and/or apathy, 4) anhedonia, and 5) impaired attention. Each item is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 150. Higher scores indicate more impairment.The PANSS contains 30 particular items divided into 3 subscores: 1)positive, 2) negative, and 3) general subscore. Each item is scored on a scale from 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment. The primary outcomes were the changes in the severity of negative symptoms as measured with SANS total score and PANSS negative subscore after 4 weeks of intervention.|Baseline, after 4 weeks of treatment|Ten patients dropped out due to different reasons (three patients refused to participated, three did not complianted and the other four were discharged before completion of study)|||units on a scale||Full Range|Mean
2622190|NCT01940900|Primary|Mean Change in Visual Acuity From Baseline to 12 Months|The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline to the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.|12 Months|Mean change in visual acuity (ETDRS letter) from Baseline to Month 12|||letters||Standard Error|Mean
2622191|NCT01940705|Secondary|International Outcome Inventory for Hearing Aids.|Hearing-aid outcomes questionnaire assessing benefit, satisfaction, use, etc. Seven items, each on a scale of 1-5. 1 = low satisfaction/benefit/use etc., 5 = maximum satisfaction/benefit/use etc. A total score is derived by summing the score from each of the seven items. Total scores range from a low of 7 to a high of 35.|4 weeks after the hearing-aid fitting|Questionnaire data are missing for one individual in the Standard of care arm, five in the SoC plus hearing-aid informational guide arm, five in the Standard of care plus a take-home digital video disc and two in the SoC plus counseling with the teach-back technique due to technical issues.|||units on a scale||Standard Deviation|Mean
2622192|NCT01940705|Secondary|The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids|12-item questionnaire assessing self-efficacy for basic and advanced hearing aid handling skills. Item responses are on a scale of 0 to 100 in 10 point increments. Score of 0 = no self efficacy to100 = complete self efficacy. Final score is an average of individual item responses.|4 weeks after the hearing-aid fitting|Questionnaire data are missing due to a technical issue for one individual in the SoC plus hearing-aid informational guide arm and one in the SoC plus counseling with the teach-back technique|||units on a scale||Standard Deviation|Mean
2622193|NCT01940705|Primary|Hearing Aid Skills and Knowledge Test|"Hearing Aid Skills and Knowledge measures knowledge and skills for tasks associated with hearing aid management, such as knowledge of and ability to change batteries, insert the hearing aid, etc. For knowledge scale, participant gives a verbal response. Items are assigned points: 0 (incorrect response) or 1 (correct response). For skills scale, participant conducts the required task. Items are assigned points: 0 (Could not perform task), 1 (Achieved with some difficulty, more than one attempt) or 2 (Achieved with no difficulty on first attempt).~There were 15 knowledge items and 19 skill items. Percent correct was computed for each scale separately. Points were totaled, divided by the no. items with valid data, and multiplied by 100, with a correction to equate subscales.~For the skills scale, percent correct scores were calculated based upon the notion that a value of 2 was considered 100% correct, 1 was considered 50% correct."|4 weeks after the hearing-aid fitting||||percentage of correct responses||Standard Deviation|Mean
2622194|NCT01940523|Secondary|The Number Patients Requiring a Transfusion|TThe number Patients requiring a transfusion over the course of the patient's hospital stay.|over course of hospital stay (averaging three days)||||Participants|||Count of Participants
2622195|NCT01940523|Secondary|Drain Output|The amount of blood collected by a drain attached to the knee is measured 24 hours after surgery.|from end of surgery to 24 hours postoperatively||||ml||Standard Deviation|Mean
2622196|NCT01940523|Primary|Total Blood Loss|The amount of blood lost during surgery is the primary outcome measure. Blood loss is determineusing an equation that calculates the patient's blood volume based on their height and weight, then multiplies the patient's blood volume by the change in their hematocrit after surgery compared to before surgery.|during surgery||||ml||Standard Deviation|Mean
2622197|NCT01940510|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by Cmax|Cmax is the maximum observed molar plasma concentration for alectinib + RO5468924 (major pharmacologically active metabolite of alectinib). Cmax is presented in nanomoles per liter (nmol/L).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||nmol/L||Standard Deviation|Mean
2622198|NCT01940510|Secondary|Total Molar Concentration of Alectinib and RO5468924 as Derived by AUC(0-inf)|AUC(0-inf) is the area under the alectinib + RO5468924 (major pharmacologically active metabolite of alectinib) molar plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the molar plasma concentration of the alectinib + RO5468924 over time. AUC(0-inf) is presented in nanomoles times (*) hour per liter (nmol*hour/L).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||nmol*hour/L||Standard Deviation|Mean
2622199|NCT01940510|Secondary|Apparent Volume of Distribution (Vz/F) of Alectinib|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction of drug absorbed.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||liters||Standard Deviation|Mean
2622200|NCT01940510|Secondary|Apparent Oral Clearance (CL/F) of Alectinib|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||liters/hour||Standard Deviation|Mean
2622201|NCT01940510|Secondary|Plasma Terminal Half-Life (t1/2) of Alectinib and RO5468924|Plasma terminal half-life is the time measured during drug elimination phase for the plasma drug concentration to decrease by one half. RO5468924 is the major pharmacologically active metabolite of alectinib.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||hours||Standard Deviation|Mean
2622202|NCT01940510|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib and RO5468924|The Tmax is the time from alectinib administration to reach Cmax for alectinib and RO5468924 (the major pharmacologically active metabolite of alectinib).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||hours||Full Range|Median
2622203|NCT01940510|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of Alectinib and RO5468924|AUC(0-last) is the area under the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) plasma concentration time-curve from time zero to the last measured concentration. AUC is a measure of the plasma concentration of a drug over time. AUC(0-last) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||ng*hour/mL||Standard Deviation|Mean
2622204|NCT01940510|Secondary|Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for Cmax|Cmax is the maximum observed plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib). The molecular weight adjusted M/P ratio (RO5468924/alectinib) for Cmax is presented.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||ratio||Standard Deviation|Geometric Mean
2622205|NCT01940510|Secondary|Molecular Weight Adjusted Metabolite to Parent (M/P) Ratio for AUC(0-inf)|AUC(0-inf) is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the alectinib and RO5468924 (major pharmacologically active metabolite of alectinib) over time. The molecular weight adjusted M/P ratio (RO5468924/alectinib) for AUC(0-inf) is presented.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||ratio||Standard Deviation|Geometric Mean
2622206|NCT01940510|Secondary|Cmax of RO5468924|Cmax is the maximum observed RO5468924 (the major pharmacologically active metabolite of alectinib) plasma concentration, presented in ng/mL.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||ng/mL||Standard Deviation|Mean
2622207|NCT01940510|Secondary|AUC(0-inf) of RO5468924|AUC(0-inf) is the area under the RO5468924 (the major pharmacologically active metabolite of alectinib) plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of the drug over time. AUC(0-inf) is presented in ng*hour/mL.|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||ng*hour/mL||Standard Deviation|Mean
2622208|NCT01940510|Primary|Maximum Observed Plasma Concentration (Cmax) of Alectinib|Cmax is the maximum observed alectinib plasma concentration, presented in nanogram per milliliter (ng/mL).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|PK analysis set|||ng/mL||Standard Deviation|Mean
2622209|NCT01940510|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC[0-inf]) of Alectinib|AUC(0-inf) is the area under the alectinib plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in nanogram times (*) hour per milliliter (ng*hour/mL).|Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib-dose in each intervention period|The Pharmacokinetic (PK) analysis set included all participants who received both scheduled doses of alectinib (on Day 1 and Day 17), and provided adequate PK assessments.|||ng*hour/mL||Standard Deviation|Mean
2622210|NCT01940497|Secondary|Percentage of Health Care Professionals (HCPs) by Response to Health Care Professional Questionnaire (HCPQ)|Percentage of HCPs providing responses to various questions related to overall ease of study drug administration was reported in different categories, where categories indicate all possible responses to such questions.|After at least 4 participants completed 5 cycles of adjuvant treatment (1 cycle = 21 days; maximum up to 1 year)|HCPQ population included all investigators and study nurses who completed the questionnaire at each site when at least 4 participants from their site had received at least 5 cycles of adjuvant study treatment (52 and 50, respectively for Vial and SID groups).|||Percentage of HCPs|||Number
2625221|NCT01914757|Secondary|Number of Patients With >=1 Asthma Exacerbation||Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Participants|||Number
2622211|NCT01940497|Secondary|Percentage of Participants by Response to Patient Satisfaction Questionnaire (PSQ)|"Participants were asked the following 5 questions: (1) Following the first injection given by the physician/nurse and training on how to use the SID, I felt comfortable injecting the study drug by myself; (2) The SID was convenient and easy to use; (3) I am confident giving myself an injection in the thigh with the SID; (4) Taking all things into account, I find self-administration using the SID satisfactory; (5) If given the opportunity, I would choose to continue self-injecting the study drug using the SID at home. Response to each question was recorded as either of the following options: Unknown, Strongly Disagree, Disagree, Unsure, Agree, Strongly Agree. Percentage of participants who provided responses to above questions was reported. Data for this outcome measure were analyzed and reported only for Trastuzumab (SID) arm."|After at least 14 cycles (1 cycle = 21 days; maximum up to 1 year)|PSQ population included all enrolled participants from trastuzumab (SID) group who were able to use SID and had completed a minimum of 14 administrations of trastuzumab subcutaneously using SID (at least 10 of which were self-administered). Here, ‘Number of Participants Analyzed’ = participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2622212|NCT01940497|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the first treatment to death from any cause. Kaplan-Meier estimates were used for analysis. Participants who did not die were censored on the date they were last known to be alive. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up to death due to any cause|m-ITT population|||Months||95% Confidence Interval|Median
2622213|NCT01940497|Secondary|Percentage of Participants Who Died|Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up to death due to any cause|m-ITT population|||Percentage of Participants|||Number
2622214|NCT01940497|Secondary|Disease-Free Survival (DFS) Using Mammography|DFS was defined as the time from the first treatment to local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first). Kaplan-Meier estimates were used for analysis. Participants who were disease-free were censored at the data cut off date. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up to local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first)|m-ITT population. Here, ‘Number of Participants Analyzed’ = participants who were evaluable for this outcome measure.|||Months||95% Confidence Interval|Median
2622215|NCT01940497|Secondary|Percentage of Participants With Event (Local, Regional or Distant Recurrence, Contralateral Breast Cancer or Death) Using Mammography|A participant was considered as disease free if the participant was free from local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first). Percentage of participants with event at the cut off date were reported. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up to local, regional or distant recurrence, contralateral breast cancer or death due to any cause (whichever occurred first)|m-ITT population. Here, ‘Number of Participants Analyzed’ = participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2622216|NCT01940497|Secondary|Percentage of Participants With Pathological Complete Response (pCR) (Neoadjuvant Groups Only) Using Mammography|In the neoadjuvant setting, the activity of two sequential drug regimens, doxorubicin-containing chemotherapy followed by paclitaxel or docetaxel chemotherapy in combination with trastuzumab, was assessed as the percentage of participants with pCR in breast and nodes using mammography. pCR was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after preoperative treatment. Data for this outcome measure were analyzed and reported only for neoadjuvant groups within each treatment arm.|Day 1 up to 24 weeks|Modified intent-to-treat (m-ITT) population included all enrolled participants satisfying criteria for eligibility.|||Percentage of Participants||95% Confidence Interval|Number
2622217|NCT01940497|Secondary|Percentage of Participants Who Received Concomitant Medications||Screening (Day -28 to -1) up to 2.5 years|Safety Population|||Percentage of Participants|||Number
2622218|NCT01940497|Secondary|Duration of Treatment With Trastuzumab|Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up last dose of trastuzumab (up to approximately 1 year)|Safety Population|||days||Standard Deviation|Mean
2622219|NCT01940497|Secondary|Actual Dose of Trastuzumab Administered|Actual dose (mg) administered = (sum over all cycles of actual dose received [mg] divided by number of cycles). Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up last dose of trastuzumab (up to approximately 1 year)|Safety Population|||mg||Standard Deviation|Mean
2622220|NCT01940497|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were the AEs occurring from starting on the day of or after first administration of trastuzumab and within 28 days after last dose of trastuzumab. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.|Day 1 up to 28 days after last dose of trastuzumab (up to approximately 1 year)|Safety population|||Percentage of Participants|||Number
2622221|NCT01940484|Secondary|Number of Participants Treated According to European Renal Best Practice Guideline (ERBPG) and National Kidney Function (NKF) Kidney Disease Outcomes Quality Initiative (NKF KDOQI) and Mircera Package Insert|Number of participants who received treatment as per the guidelines specified by ERBPG, NKF KDOQI, and Mircera package insert were to be reported.|Up to 6 months|Due to observational nature of the study, the data for this outcome measure could not be collected.||||||
2622222|NCT01940484|Secondary|Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta|Dose adjustment included dose increase or dose decrease with respect to previous visit's dose.|Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6), Visit 8 (Month 7)|Included all enrolled participants who were evaluable for this outcome measure.|||participants|||Number
2625783|NCT01908972|Secondary|Number of Participants in Which, Facial Edema Occurs, Anytime During the 16 Weeks|Number of Participants in Which, facial edema occurs, Anytime During the 16 Weeks..|up to 16weeks||||Participants|||Count of Participants
2622236|NCT01940471|Other Pre-specified|Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method.|Up to 48 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.|||percentage of participants|||Number
2622237|NCT01940471|Secondary|Change From Baseline at Week 48 in Serum Creatinine||Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.|||mg/dL||Standard Deviation|Mean
2622238|NCT01940471|Secondary|Percent Change From Baseline in Spine BMD at Week 48||Baseline; Week 48|Participants in the Spine DXA Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline spine BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.|||percentage change||Standard Deviation|Mean
2622239|NCT01940471|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48||Baseline; Week 48|Participants in the Hip Dual-Energy X-ray Absorptiometry (DXA) Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline hip BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.|||percentage change||Standard Deviation|Mean
2622240|NCT01940471|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48||Week 48|Serologically Evaluable Full Analysis Set: participants who were randomized, had received at least 1 dose of study drug, and were HBeAg positive and anti-HBe negative or had a value missing value at baseline. Participants were analyzed according to their randomized treatment group. All missing data were treated as no HBeAg seroconversion.|||percentage of participants|||Number
2622241|NCT01940471|Primary|Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL||Week 48|Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drugs. Participants were analyzed according to the treatment to which they were randomized.|||percentage of participants|||Number
2622242|NCT01940354|Secondary|Clinician Satisfaction Upon Successful PIV Placement|"Clinician Satisfaction was measured at initial PIV placement using a 5 Point Likert Scale: How easy was the AccuCath™ System to use in comparison to the current catheter? 5 - Easier to Use 4 - Somewhat Easier to Use 3 - Neutral 2 - Somewhat Difficult to Use~1 - Very Difficult to Use"|Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes|The number of patients analyzed in each group differs from the numbers in the Participant Flow due to missing data (n = 5 in Study Device arm and n = 1 in the Control Arm).|||units on a scale||Standard Deviation|Mean
2622243|NCT01940354|Secondary|Patient Satisfaction Upon Successful PIV Placement|Patient Satisfaction was measured at initial PIV placement using a 5 Point Likert Scale: 5 - Very Comfortable, 4 - Somewhat Comfortable, 3 - Neutral, 2- Somewhat Uncomfortable, 1 - Very Uncomfortable|Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes|The number of patients analyzed in each group differs from the numbers in the Participant Flow due to missing data (n = 6 in Study Device arm and n = 1 in the Control Arm).|||units on a scale||Standard Deviation|Mean
2622244|NCT01940354|Primary|First Attempt Success Rate With Peripheral IV (PIV) Catheter Placement||Baseline/at catheter placement, PIV placement duration ranges from 3-15 minutes||||Participants|||Count of Participants
2622245|NCT01940341|Other Pre-specified|Percentage of Participants With Treatment-emergent Proteinuria by Urinalysis (Dipstick) Through Week 48|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method.|Up to 48 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.|||percentage of participants|||Number
2622246|NCT01940341|Secondary|Change From Baseline in Serum Creatinine at Week 48||Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data was excluded from analysis.|||mg/dL||Standard Deviation|Mean
2622247|NCT01940341|Secondary|Percent Change From Baseline in Spine BMD at Week 48||Baseline; Week 48|Participants in the Spine DXA Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline spine BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data was excluded from analysis.|||percentage change||Standard Deviation|Mean
2622248|NCT01940341|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48||Baseline; Week 48|Participants in the Hip Dual-Energy X-ray Absorptiometry (DXA) Analysis Set (participants who were randomized, received at least 1 dose of study drugs, and had nonmissing baseline hip BMD values) with available data were analyzed. Participants were analyzed according to the treatment they actually received. Missing data were excluded from analysis.|||percentage change||Standard Deviation|Mean
2622249|NCT01940341|Primary|Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL|The primary efficacy endpoint was determined by the achievement of HBV DNA < 29 IU/mL at Week 48.|Week 48|Full Analysis set: participants who were randomized into the study and received at least 1 dose of study drugs. Participants were analyzed according to the treatment to which they were randomized.|||Percentage of participants|||Number
2622250|NCT01940146|Primary|Change in Total Nasal Symptom Score From Baseline to Day 14.|The 4-point (0=None, 1=Mild, 2=Moderate, and 3=Severe) intensity scale was summed across multiple symptoms (nasal congestion, rhinorrhea, nasal itching, and sneezing). Thus, the TNSS scores could range from 0 to 12, with higher scores indicative of greater severity.|Baseline to Day 14||||units on a scale||Standard Error|Least Squares Mean
2622251|NCT01940120|Secondary|Number of Participants With Mitral Valve Replacement|Defined as how often patients receiving surgery required replacement of the mitral valve.|48 months||||Participants|||Count of Participants
2622252|NCT01940120|Secondary|Number of Participants With Mitral Valve Replacement|Defined as how often patients receiving surgery required replacement of the mitral valve.|36 months||||Participants|||Count of Participants
2622253|NCT01940120|Secondary|Number of Participants With Mitral Valve Replacement|Defined as how often patients receiving surgery required replacement of the mitral valve.|24 months||||Participants|||Count of Participants
2622255|NCT01940120|Secondary|Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery|Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of participants|||Number
2622256|NCT01940120|Secondary|Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery|Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|48 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of participants|||Number
2622257|NCT01940120|Secondary|Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery|Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of participants|||Number
2622258|NCT01940120|Secondary|Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery|Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of participants|||Number
2622259|NCT01940120|Secondary|Percentage of Participants With Freedom From All-Cause Mortality and Mitral Valve Surgery|Kaplan-Meier estimate of the percentage of patients who are alive and did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of participants|||Number
2622260|NCT01940120|Secondary|Number of Participants With Second MitraClip Device Implanted|It is a summary of re-interventions to place an additional MitraClip Device.|0 to 5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2622261|NCT01940120|Secondary|Number of Participants With Mitral Valve Surgery Post-MitraClip Procedure|Number of patients who underwent surgical mitral valve repair or replacement after the index MitraClip procedure.|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2622262|NCT01940120|Secondary|Number of Participants With Device Embolization or Single Leaflet Device Attachment|"Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.~A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device."|60 months|Patients implanted with a MitraClip device and alive were evaluated at 60 months.|||Participants|||Count of Participants
2622263|NCT01940120|Secondary|Number of Participants With Device Embolization or Single Leaflet Device Attachment|"Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.~A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device."|36 months|Patients implanted with a MitraClip device, alive were evaluated at 36 months.|||Participants|||Count of Participants
2622264|NCT01940120|Secondary|Number of Participants With Device Embolization or Single Leaflet Device Attachment|"Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.~A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device."|48 months|Patients implanted with a MitraClip device and alive were evaluated at 48 months.|||Participants|||Count of Participants
2622265|NCT01940120|Secondary|Number of Participants With Device Embolization or Single Leaflet Device Attachment|"Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.~A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device."|24 months|Patients implanted with a MitraClip device, alive were evaluated at 24 months.|||Participants|||Count of Participants
2622266|NCT01940120|Secondary|Number of Participants With Device Embolization or Single Leaflet Device Attachment|"Device embolization is defined as bilateral Clip detachment resulting in Clip embolization. Reasons for Clip embolization include leaflet tearing, Clip unlocking, Clip fracture or inadequate Clip placement (i.e., malposition). Not included are any fractures or other failures of the Clip that do not result in Clip detachment from both leaflets.~A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device."|0 to 12 months|Three patients were excluded from the analysis as they did not receive a Device.|||Participants|||Count of Participants
2622267|NCT01940120|Secondary|Percentage of Participants With Composite Functional and Structural Measures - Freedom From Death and MR >2+|Kaplan-Meier estimated proportion of patients who are alive and have a mitral regurgitation severity grade of 2+ or less.|24 months|Primary Analysis at 24 months included only 75 patients. Three patients were excluded due to withdrawal at or before 12 months.|||percentage of participants||95% Confidence Interval|Number
2622287|NCT01940120|Secondary|Cardiac Output|CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min)|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Cardiac output evaluation was not done or un-evaluable.|||l/min||Standard Deviation|Mean
2622817|NCT01936363|Secondary|Area Under the Curve (AUC) After Dose of Pimasertib and SAR245409||Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43|As per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed.||||||
2622268|NCT01940120|Secondary|Composite Functional and Structural Measures - Percentage of Participants With Freedom From Death|"Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories:~A. Cardiac death is defined as death due to any of the following:~Acute myocardial infarction.~Cardiac perforation/pericardial tamponade.~Arrhythmia or conduction abnormality.~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure.~Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.~Any death for which a cardiac cause cannot be excluded.~B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|24 months|Analysis population includes 46 participants, which represents the number of patients at risk as per Kaplan-Meier freedom from mortality analysis at 24 months.|||percentage of participants|||Number
2622269|NCT01940120|Secondary|Number of Participants With Mitral Valve Repair Success|Freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+.|24 months|Three Acute Procedural Success (APS) patients withdrew at or before 12 months, and had MR ≤ 2+ at all visits prior to withdrawal. Since there is no data on these patients post-12 months, these patients are not included in the endpoint of freedom from mitral valve replacement surgery for Valve Dysfunction, death and MR > 2+ at 24 months.|||Participants|||Count of Participants
2622270|NCT01940120|Secondary|Number of Participants With Mitral Valve Repair Success|Mitral Valve Repair Success defined as freedom from mitral valve replacement surgery for valve dysfunction, death, re-operation and MR > 2+ at 12 months.|12 months||||Participants|||Count of Participants
2622271|NCT01940120|Secondary|Percentage of Participants With Freedom From Mitral Valve Surgery|Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|60 months|Analysis population includes 14 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 60 months.|||percentage of participants|||Number
2622272|NCT01940120|Secondary|Percentage of Participants With Freedom From Mitral Valve Surgery|Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|48 months|Analysis population includes 35 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 48 months.|||percentage of participants|||Number
2622273|NCT01940120|Secondary|Percentage of Participants With Freedom From Mitral Valve Surgery|Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|36 months|Analysis population includes 39 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 36 months.|||percentage of participants|||Number
2622274|NCT01940120|Secondary|Percentage of Participants With Freedom From Mitral Valve Surgery|Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|24 months|Analysis population includes 45 participants, which represents the number of patients at risk as per Kaplan-Meier analysis at 24 months.|||percentage of participants|||Number
2622275|NCT01940120|Secondary|Percentage of Participants With Freedom From Mitral Valve Surgery|Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|12 months|Analysis population includes 58 participants, which represents the number of patients at risk as per Kaplan-Meier freedom from Mitral valve (MV)surgery analysis at 12 months.|||percentage of participants|||Number
2622276|NCT01940120|Secondary|Percentage of Participants With Freedom From Mitral Valve Surgery|Percentage of patients who did not undergo surgical mitral valve repair or replacement after the index MitraClip procedure|Baseline||||percentage of participants|||Number
2622277|NCT01940120|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
2622278|NCT01940120|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.|48 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
2622279|NCT01940120|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
2622280|NCT01940120|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
2622281|NCT01940120|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
2622282|NCT01940120|Secondary|Left Ventricular Ejection Fraction (LVEF)|Left Ventricular Ejection Fraction (LVEF) as determined by the core echocardiography laboratory.|Discharge or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
2622283|NCT01940120|Secondary|Cardiac Index|Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.|24 months|Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients cardiac index evaluation was not done or un-evaluable.|||l/min/m2||Standard Deviation|Mean
2622284|NCT01940120|Secondary|Cardiac Index|Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Cardiac Index evaluation was not done or un-evaluable.|||l/min/m2||Standard Deviation|Mean
2622285|NCT01940120|Secondary|Cardiac Index|Cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography.|30 Days|Of 78 total population, 66 participants were included in the analysis population because of 6 deaths within 30 days and in 6 participants cardiac Index was un-evaluable or not done.|||l/min/m2||Standard Deviation|Mean
2622288|NCT01940120|Secondary|Cardiac Output (CO)|CO is defined as the volume of blood pumped by the left ventricle per unit time (L/min).|30 Days|Of 78 total population, 66 participants were included in analysis population because of 6 deaths within 30 days and in 6 patients Cardiac Output was not assessed or or un-evaluable.|||l/min||Standard Deviation|Mean
2622289|NCT01940120|Secondary|Regurgitant Fraction|RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.|24 months|Of 78 total population, 26 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and 18 patients were without Regurgitant fraction assessment.|||percentage of LV stroke volume||Standard Deviation|Mean
2622290|NCT01940120|Secondary|Regurgitant Fraction|RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.|12 months|Of 78 total population, 44 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 6 patients Regurgitant fraction evaluation was not done or not evaluable.|||percentage of LV stroke volume||Standard Deviation|Mean
2622291|NCT01940120|Secondary|Regurgitant Fraction (RF)|RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.|30 days|Of 78 total population, 58 participants were analysed as 6 participants died within 30 days and 14 missing data (not done or not evaluable).|||percentage of LV stroke volume||Standard Deviation|Mean
2622292|NCT01940120|Secondary|Regurgitant Volume|Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.|24 months|Of 78 total population, 26 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and 18 patients were without Regurgitant Volume assessment.|||mL||Standard Deviation|Mean
2622293|NCT01940120|Secondary|Regurgitant Volume|Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.|12 months|Of 78 total population, 44 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 6 patients Regurgitant volume evaluation was not done or not evaluable.|||mL||Standard Deviation|Mean
2622294|NCT01940120|Secondary|Regurgitant Volume|Regurgitant volume as measured by the core echocardiographic laboratory at follow-up.|30 days|Of 78 total population, 58 participants were included in the analysis population because of 6 deaths within 30 days and 14 missing data (not done or not evaluable).|||mL||Standard Deviation|Mean
2622295|NCT01940120|Secondary|Number of Hospital Re-Admissions for Congestive Heart Failure (CHF)|Defined as the number of hospital admissions (i.e. events) for which the primary diagnosis for hospitalization is congestive heart failure, in the 12-months post-discharge following the MitraClip procedure.|12 months|Of 78 patients, 3 patients who died prior to discharge were not included.|||Events|||Number
2622296|NCT01940120|Secondary|Number of Days Re-hospitalized for CHF|Defined as the number of days hospitalized for CHF in the 12-months prior to the Clip implant procedure date compared to the number of days re-hospitalized for CHF in the 12-months after Clip implant.|12 months|12/75 hospitalized for CHF post-discharge, representing 22 separate hospitalization events with mean of 6.6+/-3.7 days.|||days||Standard Deviation|Mean
2622297|NCT01940120|Secondary|Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2622298|NCT01940120|Secondary|Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|48 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2622299|NCT01940120|Secondary|Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2622300|NCT01940120|Secondary|Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)|Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|24 months|Of 78 total population, 42 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and LVIDd/LVIDs not done or un-evaluable in 2 patients.|||cm||Standard Deviation|Mean
2622301|NCT01940120|Secondary|Left Ventricular End-systolic Volume (LVESV).|Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
2622302|NCT01940120|Secondary|Left Ventricular End-systolic Volume (LVESV).|Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|48 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
2622303|NCT01940120|Secondary|Left Ventricular End-systolic Volume (LVESV).|Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
2622304|NCT01940120|Secondary|Left Ventricular End-systolic Volume (LVESV).|Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|24 months|Of 78 total population, 39 participants were included in the analysis population because of 26 deaths within 2 year, 7 withdrawals, 1 missed visit and LVESV was not done or un-evaluable in 5 patients.|||mL||Standard Deviation|Mean
2622305|NCT01940120|Secondary|Left Ventricular End-diastolic Volume (LVEDV).|Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
2622306|NCT01940120|Secondary|Left Ventricular End-diastolic Volume (LVEDV).|Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|48 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
2622307|NCT01940120|Secondary|Left Ventricular End-diastolic Volume (LVEDV).|Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mL||Standard Deviation|Mean
2622308|NCT01940120|Secondary|Left Ventricular End-diastolic Volume (LVEDV).|Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|24 months|Of 78 total population, 39 participants were included in the analysis population because of 26 deaths within 2 year, 7 withdrawals, 1 missed visit and LVEDV was not done or un-evaluable in 5 patients.|||mL||Standard Deviation|Mean
2622309|NCT01940120|Secondary|Number of Participants With New York Heart Association (NYHA) Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2622310|NCT01940120|Secondary|Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|48 months|Of 78 total population, 31 participants were included in the analysis population because of 33 deaths within 3 years, 8 withdrawals, 3 missed visit and NYHA was not assessed in 3 patients.|||Participants|||Count of Participants
2622311|NCT01940120|Secondary|Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|36 months|Of 78 total population, 37 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and 2 patients without NYHA Class assessment.|||Participants|||Count of Participants
2622312|NCT01940120|Secondary|Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|24 months|Of 78 total population, 43 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and 1 patient without NYHA Class assessment.|||Participants|||Count of Participants
2622313|NCT01940120|Secondary|Number of Participants With Clinical Durability|Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA.|24 months|Through 24 months, the clinical durability status of 3 patients is unknown and there were 35 patients with an acute reduction in MR severity from baseline of at least one grade (the one patient who underwent surgery between 12 months and 24 months is not included in the 35 patients).|||Participants|||Count of Participants
2622314|NCT01940120|Secondary|Number of Participants With Clinical Durability|Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA.|12 months|There were 62 patients with an acute reduction in MR severity of at least one grade, and of these, 43 patients met the criterion for clinical durability. The clinical durability rate is therefore 43/62, or 69.4%.|||Participants|||Count of Participants
2622315|NCT01940120|Secondary|Number of Participants With Treatment Durability|Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.|24 months|At 24 months, of the 56 patients who achieved acute procedural success, the status of 3 patients is unknown. Among the remaining 53 patients, 30 patients (56.6%) were alive and free from MR > 2+ at 24 months.|||Participants|||Count of Participants
2622316|NCT01940120|Secondary|Number of Participants With Treatment Durability|Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.|12 months|Of 78 total population, 56 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals and 1 missed visit.|||Participants|||Count of Participants
2622317|NCT01940120|Secondary|Number of Participants With MR Severity|MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2622318|NCT01940120|Secondary|Number of Participants With MR Severity|MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.|48 months|Of 78 total population, 31 participants were included in the analysis population because of 33 deaths within 3 years, 8 withdrawals, 3 missed visit and MR severity was not done or un-evaluable in 3 patients.|||Participants|||Count of Participants
2622319|NCT01940120|Secondary|Number of Participants With MR Severity|MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.|36 months|Of 78 total population, 37 participants were included in the analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and MR Severity was not done or un-evaluable in 2 patients.|||Participants|||Count of Participants
2622320|NCT01940120|Secondary|Number of Participants With MR Severity|MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.|24 months|Of 78 total population, 42 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and MR severity not assessed in 2 patients.|||Participants|||Count of Participants
2622321|NCT01940120|Secondary|Number of Participants With MR Severity|MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.|12 months|Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and MR Severity not done or un-evaluable in 2 patients.|||Participants|||Count of Participants
2622322|NCT01940120|Secondary|Number of Participants With MR Severity|MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.|Discharge or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2622323|NCT01940120|Secondary|Number of Participants With High Risk Procedural Success|Successful implantation of the Clip (s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA.|30 days||||Participants|||Count of Participants
2622324|NCT01940120|Secondary|Number of Participants With Successful Clip Implant|Rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.|30 Days||||Participants|||Count of Participants
2622325|NCT01940120|Secondary|Post-procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU) Time|Number of hours patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.|Length of ICU/CCU stay, assessed at 30 Days||||hours||Standard Deviation|Mean
2622326|NCT01940120|Secondary|Post-procedure Length of Hospital Stay|Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.|Length of Hospital Stay, assessed at 30 days||||days||Standard Deviation|Mean
2622327|NCT01940120|Secondary|Number of Participants Discharged to a Nursing Home or Skilled Nursing Facility or Hospital|Discharge to a nursing home or skilled nursing facility following discharge from the hospital after definitive treatment.|30 Days||||Participants|||Count of Participants
2622328|NCT01940120|Secondary|Number of Participants With New Coumadin Use|New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.|12 months|49 patients not on coumadin at baseline are included in the analysis.|||Participants|||Count of Participants
2622329|NCT01940120|Secondary|Number of Participants With New Coumadin Use|New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.|6 months|49 patients not on coumadin at baseline are included in the analysis.|||Participants|||Count of Participants
2622330|NCT01940120|Secondary|Number of Participants With New Coumadin Use|New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.|30 days|49 patients not on coumadin at baseline are included in the analysis.|||Participants|||Count of Participants
2622818|NCT01936363|Secondary|Maximum Plasma Concentration (Cmax) After Dose of Pimasertib and SAR245409||Pre-dose Hour 0.5, 1.5, 4.5 8 post dose on Day 15, 29, 43|As per changed in planned analysis the outcome measure related to pharmacokinetic parameters was not assessed.||||||
2622331|NCT01940120|Secondary|Mitral Valve Index|Mitral valve area as measured by core lab echocardiography and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)]|12 months|Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral valve index evaluation was not done or un-evaluable.|||cm^2/m^2||Standard Deviation|Mean
2622332|NCT01940120|Secondary|Mitral Valve Index|Mitral valve area as measured by core lab echocardiography and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)]|30 days|Of 78 total population, 50 participants were included in the analysis population because of 6 deaths within 30 days and in 22 participants Mitral valve index was not done or un-evaluable.|||cm^2/m^2||Standard Deviation|Mean
2622333|NCT01940120|Secondary|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||mmHg||Standard Deviation|Mean
2622334|NCT01940120|Secondary|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|48 months|Of 78 total population, 31 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and in 8 patients Mitral Valve Gradient evaluation was not done or un-evaluable.|||mmHg||Standard Deviation|Mean
2622335|NCT01940120|Secondary|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|36 months|Of 78 total population, 36 participants were included in analysis population because of 31 deaths within 2 years, 7 withdrawals, 1 missed visit and in 3 patients Mitral Valve Gradient evaluation was not done or un-evaluable.|||mmHg||Standard Deviation|Mean
2622336|NCT01940120|Secondary|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|24 months|Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Mitral Valve Gradient evaluation was not done or un-evaluable.|||mmHg||Standard Deviation|Mean
2622337|NCT01940120|Secondary|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Mitral Valve Gradient evaluation was not done or un-evaluable.|||mmHg||Standard Deviation|Mean
2622338|NCT01940120|Secondary|Transvalvular Mitral Valve Gradient|Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.|30 days|Of 78 total population, 69 participants were included in the analysis population because of 6 deaths within 30 days and in 3 participants Mitral Valve Gradient was not done or un-evaluable.|||mmHg||Standard Deviation|Mean
2622339|NCT01940120|Secondary|Mitral Valve Area Index : By Pressure Half-time Formula|Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
2622340|NCT01940120|Secondary|Mitral Valve Area Index : By Pressure Half-time Formula|Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|48 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
2622341|NCT01940120|Secondary|Mitral Valve Area Index : By Pressure Half-time Formula|Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
2622342|NCT01940120|Secondary|Mitral Valve Area Index : By Pressure Half-time Formula|Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|24 months|Of 78 total population, 40 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Mitral Valve Area evaluation was not done or un-evaluable|||cm^2/m^2||Standard Deviation|Mean
2622343|NCT01940120|Secondary|Mitral Valve Area Index : By Pressure Half-time Formula|Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Mitral Valve Area evaluation was not done or un-evaluable|||cm^2/m^2||Standard Deviation|Mean
2622344|NCT01940120|Secondary|Mitral Valve Area (MVA) Index: by Pressure-Half Time Formula|"Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to Body surface area (BSA).~[MVA Index = MVA (cm^2)/BSA (m^2)]"|30 days|Of 78 total population, 65 participants were included in analysis population because of 6 deaths and Mitral Valve Area Index by pressure half-time was not done in 7 patients.|||cm^2/m^2||Standard Deviation|Mean
2622345|NCT01940120|Secondary|Mitral Valve Area Index : By Planimetry|Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
2622346|NCT01940120|Secondary|Mitral Valve Area Index : By Planimetry|Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|48 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
2622347|NCT01940120|Secondary|Mitral Valve Area Index : By Planimetry|Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2/m^2||Standard Deviation|Mean
2622841|NCT01935947|Other Pre-specified|Predictive and Prognostic Value of the Previously Defined Epigenetic Signature, Comprised of Promoter Methylation Analysis of 4 Target Genes||After 1 month of therapy|Data was not collected to assess this outcome measure due to early study termination.||||||
2622348|NCT01940120|Secondary|Mitral Valve Area Index : By Planimetry|Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|24 months|Of 78 total population, 19 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 25 patients Mitral Valve Area evaluation was not done or un-evaluable|||cm^2/m^2||Standard Deviation|Mean
2622349|NCT01940120|Secondary|Mitral Valve Area Index : By Planimetry|Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|12 months|Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral Valve Area evaluation was not done or un-evaluable.|||cm^2/m^2||Standard Deviation|Mean
2622350|NCT01940120|Secondary|Mitral Valve Area Index : By Planimetry|Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].|30 days|Of 78 total population, 50 participants were included in analysis population because of 6 deaths and Mitral Valve Area Index by planimetry was not done in 22 patients.|||cm^2/m^2||Standard Deviation|Mean
2622351|NCT01940120|Secondary|Mitral Valve Area: By Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2622352|NCT01940120|Secondary|Mitral Valve Area: By Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|48 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2622353|NCT01940120|Secondary|Mitral Valve Area: By Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2622354|NCT01940120|Secondary|Mitral Valve Area: By Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|24 months|Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Mitral valve area evaluation was not done or un-evaluable.|||cm^2||Standard Deviation|Mean
2622355|NCT01940120|Secondary|Mitral Valve Area: By Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|12 months|Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Mitral valve area evaluation was not done or un-evaluable.|||cm^2||Standard Deviation|Mean
2622356|NCT01940120|Secondary|Mitral Valve Area: By Pressure Half-time|Mitral valve area as measured by core lab echocardiography.|30 days|Of 78 total population, 66 participants were included in analysis population because of 6 deaths and in 6 patients Mitral valve area evaluation was not done or un-evaluable.|||cm^2||Standard Deviation|Mean
2622357|NCT01940120|Secondary|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|60 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm^2||Standard Deviation|Mean
2622358|NCT01940120|Secondary|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|48 months|Of 78 total population, 18 participants were included in analysis population because of 33 deaths within 4 years, 8 withdrawals, 3 missed visit and in 16 patients Mitral Valve Area evaluation was not done or un-evaluable.|||cm^2||Standard Deviation|Mean
2622359|NCT01940120|Secondary|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|36 months|Of 78 total population, 25 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and in 14 patients mitral valve area evaluation was not done or un-evaluable.|||cm^2||Standard Deviation|Mean
2622360|NCT01940120|Secondary|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|24 months|Of 78 total population, 19 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 25 patients Mitral valve area evaluation was not done or un-evaluable.|||cm^2||Standard Deviation|Mean
2622361|NCT01940120|Secondary|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|12 months|Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral valve area evaluation was not done or un-evaluable.|||cm^2||Standard Deviation|Mean
2622362|NCT01940120|Secondary|Mitral Valve Area: By Planimetry|Mitral valve area as measured by core lab echocardiography.|30 days|Of 78 total population, 50 participants were included in analysis population because of 6 deaths and Mitral Valve Area by planimetry was not done in 22 patients.|||cm^2||Standard Deviation|Mean
2622363|NCT01940120|Secondary|Number of Participants With Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|48 months||||Participants|||Count of Participants
2622364|NCT01940120|Secondary|Number of Participants With Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|36 months||||Participants|||Count of Participants
2622365|NCT01940120|Secondary|Number of Participants With Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|24 months||||Participants|||Count of Participants
2622366|NCT01940120|Secondary|Number of Participants With Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|12 months|Of total 78 participants, only 72 participants were analyzed because 3 patients were not implanted with a device and 3 patients died prior to discharge.|||Participants|||Count of Participants
2622367|NCT01940120|Secondary|Number of Participants With Mitral Valve Stenosis|Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.|30 days|Of total 78 participants, only 72 participants were analyzed as 6 deaths within 30 days.|||Participants|||Count of Participants
2622368|NCT01940120|Secondary|Number of Participants With Atrial Septal Defect (ASD)|Occurrence of clinically significant ASD as a result of the procedure requiring intervention.|12 months||||Participants|||Count of Participants
2622369|NCT01940120|Secondary|Number of Participants With Atrial Septal Defect (ASD)|Occurrence of clinically significant ASD as a result of the procedure requiring intervention.|30 days||||Participants|||Count of Participants
2622370|NCT01940120|Secondary|Number of Participants With Endocarditis|"Using Duke Criteria, endocarditis can be confirmed by:~Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed & histologically confirmed showing active endocarditis.~Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria.~Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation.~Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, & positive blood culture or echocardiogram not meeting major criteria."|12 months||||Participants|||Count of Participants
2622371|NCT01940120|Secondary|Number of Participants With Endocarditis|"Using Duke Criteria, endocarditis can be confirmed by:~Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed & histologically confirmed showing active endocarditis.~Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria. Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation. Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, & positive blood culture or echocardiogram not meeting major criteria."|30 days||||Participants|||Count of Participants
2622372|NCT01940120|Secondary|Number of Participants With Dysrhythmias|Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.|12 months||||Participants|||Count of Participants
2622373|NCT01940120|Secondary|Number of Participants With Dysrhythmias|Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.|30 days||||Participants|||Count of Participants
2622374|NCT01940120|Secondary|Number of Participants With Hemolysis|Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms.|12 months||||Participants|||Count of Participants
2622375|NCT01940120|Secondary|Number of Participants With Hemolysis|Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms|30 days||||Participants|||Count of Participants
2622376|NCT01940120|Secondary|Number of Participants With Thrombosis|Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.|12 months||||Participants|||Count of Participants
2622377|NCT01940120|Secondary|Number of Participants With Thrombosis|Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.|30 days||||Participants|||Count of Participants
2622378|NCT01940120|Secondary|Number of Participants With Non-cerebral Thromboembolism|Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.|12 months||||Participants|||Count of Participants
2622379|NCT01940120|Secondary|Number of Participants With Non-cerebral Thromboembolism|Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.|30 days||||Participants|||Count of Participants
2622380|NCT01940120|Secondary|Number of Participants With Major Bleeding Complications|Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.|12 months||||Participants|||Count of Participants
2622381|NCT01940120|Secondary|Number of Participants With Major Bleeding Complications|Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.|30 days||||Participants|||Count of Participants
2622382|NCT01940120|Secondary|Number of Participants Experiencing Major Vascular Complications|"Defined as the occurrence of any of the following resulting from the index procedure:~Hematoma at access site >6 cm;~Retroperitoneal hematoma;~Arterial-venous fistula;~Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours;~Vascular surgical repair at catheter access sites;~Pulmonary embolism;~Ipsilateral deep vein thrombus; or~Access site-related infection requiring intravenous antibiotics and/or extended hospitalization."|12 months||||Participants|||Count of Participants
2622383|NCT01940120|Secondary|Number of Participants Experiencing Major Vascular Complications|"Defined as the occurrence of any of the following resulting from the index procedure:~Hematoma at access site >6 cm;~Retroperitoneal hematoma;~Arterial-venous fistula;~Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours;~Vascular surgical repair at catheter access sites;~Pulmonary embolism;~Ipsilateral deep vein thrombus; or~Access site-related infection requiring intravenous antibiotics and/or extended hospitalization."|30 days||||Participants|||Count of Participants
2622384|NCT01940120|Secondary|Number of Participants Over 75 Years of Age With MAE|Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.|12 months|Analysis population includes 48 patients who were aged 75 years or older in the study.|||Participants|||Count of Participants
2622842|NCT01935947|Other Pre-specified|Genome-wide Techniques, Including Expression Array and Methylation Array|Expression array and methylation array will be compared to response.|After 1 month of therapy|Data was not collected to assess this outcome measure due to early study termination.||||||
2622385|NCT01940120|Secondary|Number of Participants Over 75 Years of Age With MAE|Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.|30 days|Analysis population includes 48 patients who were aged 75 years or older in the study.|||Participants|||Count of Participants
2622386|NCT01940120|Secondary|Procedural Freedom From In-hospital MAE|Percutaneous Clip procedure or surgery with no occurrence of in-hospital MAE.|30 Days||||participants|||Number
2622387|NCT01940120|Secondary|Number of Participants Experiencing Major Adverse Events|Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.|12 months||||Participants|||Count of Participants
2622388|NCT01940120|Secondary|Number of Participants Experiencing Major Adverse Events (MAE)|Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.|30 days||||Participants|||Count of Participants
2622389|NCT01940120|Primary|Left Ventricular (LV) Function - Internal Dimension|Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|Discharge or 30 days||||cm||Standard Deviation|Mean
2622390|NCT01940120|Primary|Left Ventricular End Systolic Volume (LVESV)|Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|Discharge or 30 days||||ml||Standard Deviation|Mean
2622391|NCT01940120|Primary|Left Ventricular End Diastolic Volume (LVEDV)|Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|Discharge or 30 days||||ml||Standard Deviation|Mean
2622392|NCT01940120|Primary|Number of CHF Events Leading to Hospitalizations During Discharge Through 12 Months|Incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.|12 months|Three patients died before discharge and thus do not provide data on post-discharge hospitalizations.|||Participants|||Count of Participants
2622393|NCT01940120|Primary|Number of Patients With CHF Having Hospitalization During Discharge Through 12 Months|Number of patients with incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.|12 months|Three patients died before discharge and thus do not provide data on post-discharge hospitalizations.|||Participants|||Count of Participants
2622394|NCT01940120|Primary|Left Ventricular (LV) Function - Internal Dimension|Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|12 months|Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LIVDs/LVIDs evaluation was not done or un-evaluable in 2 patients.|||cm||Standard Deviation|Mean
2622395|NCT01940120|Primary|Left Ventricular End Systolic Volume (LVESV)|Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|12 months|Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LVESV was not done or un-evaluable in 2 patients.|||ml||Standard Deviation|Mean
2622396|NCT01940120|Primary|Left Ventricular End Diastolic Volume (LVEDV)|Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).|12 months|Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LVEDV was not done or un-evaluable in 2 patients.|||ml||Standard Deviation|Mean
2622397|NCT01940120|Primary|Clinical Measures of Benefit-Quality of Life (QOL) as Measured by Short Form (SF) 36|Standardized quality of life surveys allow physicians to evaluate the effectiveness of different treatment methods and the physical and psychological benefits a patient is likely to receive from a particular treatment.In the EVEREST II HRR,the patients were asked to complete the SF-36 QOL survey at baseline, 30 days and 12 months. The physical & mental function were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. The PCS & MCS norms for 65-75 year olds are 44 and 52 respectively; and 31 & 46 for congestive heart failure (CHF) patients respectively. Each scale from the SF-36 is an algebraic sum of responses for all items in that scale.For ease of analysis each scale is then transformed to a 0-100 scale using a formula that converts the lowest & highest possible scores to 0 & 100 respectively.The scoring of the SF-36 indicates that 0% in a domain represents the poorest possible QoL & 100% indicates full QoL.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||score on a scale||Standard Deviation|Mean
2622398|NCT01940120|Primary|Number of Participants With New York Heart Association (NYHA) Class|"Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 months|Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and 2 patients without NYHA Class assessment.|||Participants|||Count of Participants
2625896|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||mmol/L||Standard Deviation|Mean
2622399|NCT01940120|Primary|Number of Participants With Clinical Measures of Benefit-New York Heart Association (NYHA) Class|"The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including New York Heart Association (NYHA) Class.~Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|71 out of 78 patients (at baseline) were analyzed at 30 days. There were 6 deaths prior to 30 days. So, NYHA at 30 days is missing due to death in 6 patients, and missing due to other reasons in 1 patient.|||Participants|||Count of Participants
2622400|NCT01940120|Primary|Percentage of Participants With Freedom From Death and Mitral Regurgitation (MR) >2+|Kaplan-Meier estimated percentage of patients who are alive and have a mitral regurgitation severity grade of 2+ or less|12 months||||percentage of participants|||Number
2622401|NCT01940120|Primary|Composite Functional and Structural Measures - Freedom From Death|"Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories:~A. Cardiac death is defined as death due to any of the following:~Acute myocardial infarction.~Cardiac perforation/pericardial tamponade.~Arrhythmia or conduction abnormality.~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure.~Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.~Any death for which a cardiac cause cannot be excluded.~B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|12 months||||Participants|||Count of Participants
2622402|NCT01939977|Secondary|Change on Concentration of Bone Markers (FGF-23) at 6 Months After Transplantation on Each Treatment Group||6 months|This value was missing for some patients|||pg/mL||Standard Deviation|Mean
2622403|NCT01939977|Secondary|Change on Concentration of Bone Markers (Alkaline Phosphatase) at 6 Months After Transplantation on Each Treatment Group.||6 months|This value was missing for some patients at month 6|||ug/L||Standard Deviation|Mean
2622404|NCT01939977|Secondary|Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group.||6 months||||Participants|||Count of Participants
2622405|NCT01939977|Secondary|Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation.|HLAs corresponding to MHC (major histocompatibility complex) class I (A, B, and C) present peptides from inside the cell. HLAs corresponding to MHC class II (DP, DM, DO, DQ, and DR) present antigens from outside of the cell to T-lymphocytes.|6 months||||Participants|||Count of Participants
2622406|NCT01939977|Secondary|Percentage of Patients With Hypercalcemia on Each Treatment Group at 6 Months Post Transplantation.|Percentage of patients with hypercalcemia (defined as serum calcium levels > 10,3 mg/dl) on each treatment group at 6 months post transplantation.|6 months||||Participants|||Count of Participants
2622407|NCT01939977|Secondary|Evolution of Speed of Pulse Wave From Month 1 to Month 6 Post Transplantation.|Baseline speed of pulse wave was performed between 1 week and 1 month post transplant; next measure of speed of pulse wave performed at month 6 post transplant.|6 months.||||Participants|||Count of Participants
2622408|NCT01939977|Secondary|Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation.||Months 1, 3 and 6||||Participants|||Count of Participants
2622409|NCT01939977|Secondary|Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation.||Months 1, 3 and 6||||Participants|||Count of Participants
2622410|NCT01939977|Secondary|Percentage of Patients With Acute Rejection at 6 Months After Transplantation and Treatment on Each Treatment Group.||6 months||||Participants|||Count of Participants
2622411|NCT01939977|Secondary|Change on Concentration of Bone Markers (Osteocalcin) at 6 Months After Transplantation on Each Treatment Group.||6 months|This value was missing for some patients at month 6|||Osteocalcin ng/ml||Standard Deviation|Mean
2622412|NCT01939977|Secondary|Patients That Suffered the Following Events: Acute Rejection, Acute Rejection Confirmed With Biopsy and/or Subclinic Rejection and/or Chronic Damage.|Patients with at least one of the following events: acute rejection, acute rejection confirmed with biopsy and/or subclinic rejection and/or chronic damage.|6 months||||Participants|||Count of Participants
2622413|NCT01939977|Secondary|Percentage of Patient With Presence of Calcifications on Protocol Renal Biopsies at 6 Months After Treatment in Each Treatment Group.||6 months||||Participants|||Count of Participants
2622414|NCT01939977|Secondary|Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT.||6 month||||Participants|||Count of Participants
2622415|NCT01939977|Secondary|Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study.||6 months||||Participants|||Count of Participants
2622416|NCT01939977|Secondary|Change on iPTH Serum Concentration. Intention to Treat Analysis.|Change on iPTH serum concentration on each treatment group 6 month post transplantation.|6 months||||iPTH pg/ml||Standard Deviation|Mean
2622417|NCT01939977|Primary|Percentage of Patients With iPTH Serum Concentration >110 pg/mL.|Percentage of patients with iPTH serum concentration >110 pg/mL 6 month after transplant.|6 months||||Participants|||Count of Participants
2622418|NCT01939938|Secondary|MRI of Upper Airway With Opposite PAP Mask|MRI will be used to obtain airway measurements and the position of soft tissue elements of the oropharyngeal airway will be evaluated while positive airway pressure in introduced through the opposite mask type.|Approximately 1 hour||||Participants|||Count of Participants
2622419|NCT01939938|Primary|AHI|The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour.|through study completion, an average of 1 hour||||events per hour||Standard Deviation|Mean
2622843|NCT01935947|Secondary|Progression Free Survival|From the time of randomization until radiologic or clinical progression is noted, assessed up to 2 years.|up to 2 years|Data was not collected to assess this outcome measure due to early study termination.||||||
2622420|NCT01939899|Secondary|Lead-in Dose Finding Phase: AUC(0-168): Area Under the Plasma Concentration-time Curve From Time 0 to 168 Hours Postdose for Ixazomib||Cycle 1, Days 1 and 15 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK analysis set where Cycle 1 Day 1 and 15 assessment were available. The PK analysis population included all participants enrolled in the lead-in dose finding phase that had sufficient dosing data and ixazomib concentration-time data. The PK analysis population where data at specified time points was available.|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
2622421|NCT01939899|Secondary|Lead-in Dose Finding Phase: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib||Cycle 1, Days 1 and 15 pre-dose and at multiple time points (up to 168 hours) post-dose|The PK analysis population included all participants enrolled in the lead-in dose finding phase that had sufficient dosing data and ixazomib concentration-time data. The PK analysis population where data at specified time points was available.|||hour||Full Range|Median
2622422|NCT01939899|Secondary|Lead-in Dose Finding Phase: Cmax: Maximum Observed Plasma Concentration for Ixazomib||Cycle 1, Days 1 and 15 pre-dose and at multiple time points (up to 168 hours) post-dose|The plasma pharmacokinetic (PK) analysis population included all participants enrolled in the lead-in dose finding phase that had sufficient dosing data and ixazomib concentration-time data. The PK analysis population where data at specified time points was available.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2622423|NCT01939899|Secondary|Number of Participants Experiencing 1 or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||Baseline up to 30 days after last dose of study drug (approximately up to Day 832)|The safety population included all enrolled participants who had received at least 1 dose of ixazomib.|||participants|||Number
2622424|NCT01939899|Secondary|Phase 2: Number of Participants With Response Rates in PSMB1 Positive and PSMB1 Negative||Baseline up to occurrence of disease progression, unacceptable toxicities, or discontinuation of study due to any other reasons (approximately up to Day 802)|The biomarker population included all participants positive or negative for the PSMB1 biomarker and where the assay has passed quality control. Data will be derived from a baseline blood sample.|||participants|||Number
2622425|NCT01939899|Secondary|Duration of Response (DOR)|The DOR is defined as the time from the date of first documentation of a response to the date of first documented PD. Responders without documentation of PD will be censored at the date of last response assessment. DOR was categorized as CR+PR and CR.|Time from the date of first documentation of a response to the date of first documented PD (approximately up to Day 802)|The response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and had at least 1 post baseline disease assessment. Participants who were evaluable for this given measure at a given time point were included for this assessment.|||months||95% Confidence Interval|Median
2622426|NCT01939899|Secondary|Time to Response (TTR)|TTR is defined as the time from the date of first dose of study treatment to the date of the first documentation of a PR or better response in a participant who responded.|Time from the date of first dose of study treatment to the date of first documented PR or better response or death (approximately up to Day 802)|The response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and had at least 1 post baseline disease assessment. Participants who were evaluable for this given measure at a given time point were included for this assessment.|||days||95% Confidence Interval|Median
2622427|NCT01939899|Secondary|Phase 2: Rate of Disease Control|Rate of disease control is defined as percentage of participants who achieved a SD or better for greater than or equal to (>=) 6 months.|Baseline or until occurrence of disease progression, unacceptable toxicities, or discontinuation of study due to any other reasons (approximately up to Day 805)|The response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and had at least 1 post baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2622428|NCT01939899|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from the date of first dose of study treatment to the date of first documented PD or death. Participants without documentation of PD will be censored at the date of last response assessment that is SD or better. Participants without response assessment will be censored at the date of first dose.|Time from the date of first dose of study treatment to the date of first documented PD or death (approximately up to Day 802)|The modified intent-to-treat (mITT) population included all participants who received at least 1 dose of ixazomib in the phase 2 portion of the study or who received at least 1 dose of ixazomib and are treated at the RP2D in the lead-in dose finding phase of the study.|||months||95% Confidence Interval|Median
2622429|NCT01939899|Secondary|Lead-in Dose Finding Phase: Recommended Phase 2 Dose (RP2D)||Baseline up to Cycle 1 Day 28|The dose limiting toxicity (DLT)- evaluable population included all participants who received all Cycle 1 doses of ixazomib and had completed Cycle 1 safety procedures, or experience a DLT in Cycle 1 in the lead-in dose finding phase of the study.|||mg|||Number
2622430|NCT01939899|Primary|Number of Participants With Overall Response Rate (ORR)|ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the investigator using the international Working Group criteria for participants CR: disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.|Baseline up to Day 15 Cycle 29 (approximately up to Day 802) or until PD or the start of alternate therapies|The response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and had at least 1 post baseline disease assessment.|||participants|||Number
2622431|NCT01939548|Secondary|Concentration of PF-02545920 and Its Metabolite, PF-01001252|Pharmacokinetic (PK) samples were collected at varying times relative to drug dosing whenever participants could be scheduled for study visits (sparse PK sampling). Thus, because of the variable time between the last dose and the collection of the PK samples, typical summary PK analyses were not planned or described in the study protocol and are not available. The study protocol analysis section specified that the sparse sampled PK data might be pooled with PK data from previous PF-02545920 clinical studies, however the study results did not support conducting those analyses.|Days 14, 28, 42, 56, 70, 84/Early Termination|Summary PK analyses were not planned or performed due to sparse PK sampling.||||||
2622432|NCT01939548|Secondary|Overall Number of Participants With Positive Responses to Categories on the Columbia Suicide Severity Rating Scale (C-SSRS)|"C-SSRS assessed whether participant experienced the following: completed suicide (Category 1), suicide attempt (Category 2; response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (Category 3; Yes on preparatory acts or behavior), suicidal ideation (Category 4; Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (Category 7; Yes on Has subject engaged in non-suicidal self-injurious behavior)."|Baseline up to 7-10 days after last dose of study drug|All participants who had received at least 1 dose of study drug.|||participants|||Number
2622433|NCT01939548|Secondary|Absolute Values of Movement Disorder Burden Score - Dystonia (MDBS-D) Over Active Treatment Period|The MDBS-D quantified the dystonia burden during the active treatment period. For an individual participant, MDBS-D took into account all treatment-emergent dystonia events and was defined as a combination of the severity of the AE due to dystonia, AE duration, prescribed concomitant medication, and the total number of days the study treatment was received. Scores for the MDBS-D ranged from 0 (no dystonia events) to 4.5, with higher scores indicating greater dystonia burden.|Active treatment period (Weeks 1 to 12/Early Termination)|All participants who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2622434|NCT01939548|Secondary|Change From Baseline to Week 12 on the Extrapyramidal Symptom Rating Scale‑Abbreviated (ESRS‑A)|The ESRS-A is a 28-item instrument designed to facilitate standardized observations of parkinsonism, dystonia, dyskinesia, and akathisia. Ratings were determined through a combination of clinical interview and a motor examination. Scores were divided into individual domain scores and clinical global impression scores (CGI-S). Scores started from 0 (normal) to 6 (0 to 8 for CGI-S), with higher scores indicating greater severity.|Baseline, Week 12|All participants who received at least 1 dose of study drug. n=number of evaluable participants for each parameter at the specified time points.|||units on a scale||Standard Deviation|Mean
2622435|NCT01939548|Secondary|Change From Baseline in Prolactin at Weeks 6 and 12|Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).|Baseline; Weeks 6 and 12|All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.|||nanogram (ng)/milliliter||Standard Deviation|Mean
2622436|NCT01939548|Secondary|Change From Baseline in Insulin at Weeks 6 and 12|Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).|Baseline; Weeks 6 and 12|All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.|||micro international unit/milliliter||Standard Deviation|Mean
2622437|NCT01939548|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 6 and 12|Choleseterol, TG, HbA1c, LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).|Baseline; Weeks 6 and 12|All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.|||percent||Standard Deviation|Mean
2622438|NCT01939548|Secondary|Change From Baseline in Cholesterol, Triglycerides (TG), Low-Density Lipoprotein (LDL), and High-Density Lipoprotein (HDL) at Weeks 6 and 12|Choleseterol, TG, glycosylated hemoglobin (HbA1c), LDL, HDL, insulin, and prolactin were a part of the laboratory tests done (metabolic tests).|Baseline; Weeks 6 and 12|All participants who had received at least 1 dose of study drug and who had available data for metabolic parameters. n=number of evaluable participants at the specified time points.|||milligram (mg)/deciliter (dL)||Standard Deviation|Mean
2622439|NCT01939548|Secondary|Number of Participants With Extrapyramidal Motor System (EPS) AEs|EPS AEs consisted of oromandibular dystonia, extrapyramidal disorder, akathisia, dyskinesia, and tremor.|Baseline up to 7-10 days after last dose of study drug (follow-up)|All participants who received at least 1 dose of study drug were included in the AE summarization/analysis.|||participants|||Number
2622440|NCT01939548|Secondary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function, renal function, lipids, electrolytes, hormones (prolactin), clinical chemistry, and urinalysis (dipstick and microscopy).|Screening up to Week 12/Early Termination and 7-10 days after last dose of study drug (hematology only)|All participants who had received at least 1 dose of study drug and who were evaluable for laboratory abnormalities.|||participants|||Number
2622441|NCT01939548|Secondary|Number of Participants With New/Intensified Physical Examination Findings From Baseline by Body Site|A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems.|Baseline and Week 12 or Early Termination|All participants who received at least 1 dose of study drug and who were evaluable for physical examinations.|||participants|||Number
2622442|NCT01939548|Secondary|Number of Participants With Weight Change >=7%|The effects of PF-02545920 on body weight were evaluated. The number of participants with changes from baseline in body weight of >=7% were tabulated and summarized.|Screening up to Day 84|All participants who received at least 1 dose of study treatment.|||participants|||Number
2622443|NCT01939548|Secondary|Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria|Criteria for ECG (12-lead) values meeting categorical summarization criteria were: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval >=300 milliseconds (msec) and increase from baseline >=25/50%; time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec and increase of >=50%; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) of 450 to <480 msec, 480 to <500 msec and >=500 msec, or an increase of 30 to <60 msec or >=60 msec.|Screening/Baseline up to Week 12 (or Early Termination)|All participants who received at least 1 dose of study drug were included in the safety analyses. n=number of evaluable participants for each specified ECG parameter.|||participants|||Number
2622444|NCT01939548|Secondary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria|Categorical summarization criteria in vital signs included: sitting, supine, and standing systolic blood pressure (SBP) of less than (<)90 millimeters of mercury (mm Hg) or change in sitting, supine and standing SBP of more than or equal to (>=)30 mm Hg; supine, sitting, and standing diastolic blood pressure (DBP) of <50 mm Hg or change in sitting, supine, and standing DBP of >=20 mm Hg; supine and sitting pulse rate of <40 or more than (>)120 beats per minute (bpm); and standing pulse rate of <40 or >140 bpm.|Screening up to 7-10 days after last dose of study drug (follow-up)|All participants who received at least 1 dose of study drug were included in the safety analyses. n=number of evaluable participants for each specified vital sign parameter.|||participants|||Number
2622445|NCT01939548|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAEs) were defined as newly occurring AEs or those worsening after first dose.|Baseline up to 7-10 days after last dose of study drug (follow-up)|All participants who received at least 1 dose of study drug were included in the AE summarization/analysis.|||participants|||Number
2622446|NCT01939548|Secondary|Clinical Global Impression - Improvement (CGI-I) Total Score at Week 12|CGI-I: 7-point clinician-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 12|Participants in the FAS who were evaluable for this outcome measure at Week 12.|||units on a scale||Standard Deviation|Mean
2622447|NCT01939548|Secondary|Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S)|CGI-S: 7-point clinician-rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.|Baseline, Week 12|All participants who received study treatment were included in the baseline evaluation. n=number of evaluable participants in the FAS at the specified time point.|||units on a scale||Standard Deviation|Mean
2622448|NCT01939548|Secondary|Change From Baseline to Week 12 in PANSS-Derived Marder Factor Scores|The subscales based on Marder factors are: negative symptoms, positive symptoms, disorganized thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 7 to 49 for negative symptoms, 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for uncontrolled hostility/excitement and anxiety/depression. Higher scores indicate higher severity of symptoms.|Baseline, Week 12|All participants who received study treatment were included in the baseline evaluation. At Week 12, the number of evaluable participants in the FAS were 40, 33, and 49.|||units on a scale||Standard Deviation|Mean
2622449|NCT01939548|Secondary|Change From Baseline to Week 12 in PANSS Positive, Negative, and General Subscales|The PANSS includes 3 scales and 30 items: 7 items that make up the Positive Scale (eg, delusions, conceptual disorganization, hallucinatory behavior); 7 items that make up the Negative Scale (eg, blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); and 16 items that make up the General Psychopathology Scale (eg, somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, preoccupation). Individual items are scored with values ranging from 1 to 7. Total Negative and Positive Subscale scores each range from 7 to 49; higher score indicates greater severity. Total General Psychopathology Subscale score range from 16 to 112; higher score indicates greater severity.|Baseline, Week 12|All participants who received study treatment were included in the baseline evaluation. At Week 12, the number of evaluable participants in the FAS were 40, 33, and 49.|||units on a scale||Standard Deviation|Mean
2622450|NCT01939548|Secondary|Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Total Score|The Personal and Social Performance Scale (PSP) is a validated clinician-related scale that measured personal and social functioning in the domains of: socially useful activities (eg, work and study), personal and social relationships, self-care, disturbing and aggressive behaviors. Information from the participant and the informant were utilized in determining the rating. A PSP total score was determined from the 4 domains (score range 0-100). A score between 71 and 100 indicates a mild degree of difficulty; a score between 31 and 70 indicates a moderate degree of dysfunction, and a participant with a score of 30 or less has functioning so poor he or she requires intensive supervision.|Baseline, Week 12|All participants who received study treatment were included in the baseline evaluation. The number of evaluable participants at Week 12 were those in the FAS with available data at Week 12 (n=number of evaluable participants at the specified time point)|||units on a scale||Standard Deviation|Mean
2622451|NCT01939548|Primary|Change From Baseline to Week 12 in PANSS Total Score|The PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210; higher score indicates greater severity.|Baseline, Week 12|All participants in the Full Analysis Set (FAS, defined as all participants who received at least 1 dose of randomized study medication, had a baseline and at least 1 post-baseline measurement) who had available data for this outcome measure at Week 12.|||units on a scale||Standard Deviation|Mean
2622452|NCT01939548|Primary|Positive and Negative Syndrome Scale (PANSS) Total Score at Baseline|The Positive and Negative Syndrome Scale (PANSS) assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS Total Score and ranges from 30 to 210; higher score indicates greater severity.|Baseline|All participants who received study treatment.|||units on a scale||Standard Deviation|Mean
2622844|NCT01935947|Secondary|Overall Survival (OS)||From the time of enrollment to trial until death, assessed up to 2 years|Data was not collected to assess this outcome measure due to early study termination.||||||
2622453|NCT01939496|Secondary|Change From Baseline in the Difference in Seated Heart Rate (HR) and Standing HR to Day 2, to Week 3, and to Week 6|The difference in seated heart rate and standing heart rate was evaluated.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||beats per minute||Standard Deviation|Mean
2622454|NCT01939496|Secondary|Change From Baseline in the Difference in Seated Office Blood Pressure (BP) and Standing Office BP to Day 2, to Week 3, and to Week 6|The difference in seated office blood pressure and standing office blood pressure was evaluated.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2622455|NCT01939496|Secondary|Change From Baseline in Standing Heart Rate (HR) to Day 2, to Week 3, and to Week 6|The standing heart rate was evaluated.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||beats per minute||Standard Deviation|Mean
2622456|NCT01939496|Secondary|Change From Baseline in Seated Heart Rate (HR) to Day 2, to Week 3, and to Week 6|The seated heart rate was evaluated.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||beats per minute||Standard Deviation|Mean
2622457|NCT01939496|Secondary|Change From Baseline in Standing Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6|The standing office blood pressure (BP) was evaluated for all participants based on the 24-hour BP recordings. SBP=Systolic Blood Pressure and DBP=Diastolic Blood Pressure.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2622458|NCT01939496|Secondary|Change From Baseline in Seated Office Blood Pressure (BP) to Day 2, to Week 3, and to Week 6|The seated office blood pressure (BP) was evaluated for all participants based on the 24-hour BP recordings. SBP=Systolic Blood Pressure and DBP=Diastolic Blood Pressure.|Baseline, Day 2, Week 3 and 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2622459|NCT01939496|Secondary|Change From Baseline in Body Weight to Week 6|Body weight was evaluated.|Baseline and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||Kilogram (kg)||Standard Deviation|Mean
2622460|NCT01939496|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) to Week 6|The fasting plasma glucose was evaluated.|Baseline and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2622461|NCT01939496|Secondary|Change From Baseline in Mean Nighttime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6|The nocturnal fall (nighttime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2622462|NCT01939496|Secondary|Change From Baseline in Mean Nighttime Systolic Blood Pressure (SBP) to Day 2 and to Week 6|The nocturnal fall (nighttime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2622463|NCT01939496|Secondary|Change From Baseline in Mean Daytime Diastolic Blood Pressure (DBP) to Day 2 and to Week 6|The diurnal rise (daytime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2622464|NCT01939496|Secondary|Change From Baseline in Mean Daytime Systolic Blood Pressure (SBP) to Day 2 and to Week 6|The diurnal rise (daytime) in blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2622465|NCT01939496|Secondary|Change From Baseline in the Mean 24-Hour Diastolic Blood Pressure (DBP) to Day 2 and to Week 6|The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline, Day 2 and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2622466|NCT01939496|Secondary|Change From Baseline in Mean 24-Hour Systolic Blood Pressure (SBP) to Day 2|The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline and Day 2|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using LOCF method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2622467|NCT01939496|Primary|Change From Baseline in the Mean 24-Hour Systolic Blood Pressure (SBP) to Week 6|The blood pressure (BP) was evaluated by Ambulatory Blood Pressure Monitoring (ABPM) for all participants based on the 24-hour BP recordings.|Baseline and Week 6|The full analysis set included all randomized participants who took at least 1 dose of double blind study medication. Here, “n” specifies those participants who were evaluated for this outcome measure at given time point. Missing data was imputed using last observation carried forward (LOCF) method.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2622468|NCT01939405|Secondary|Sedentary Time|Longer-term change in sedentary (non-active) time from baseline to 3-4 months post-intervention, objectively measured using accelerometers.|4 months from baseline||||minutes||Standard Deviation|Median
2622469|NCT01939405|Secondary|Sedentary Time|Short-term change in sedentary (non-active) time from baseline to post-intervention, objectively measured using accelerometers|Immediately post-intervention||||minutes||Standard Deviation|Median
2622470|NCT01939405|Secondary|Moderate-to-Vigorous Physical Activity (MVPA)|Longer term change in MVPA from baseline to 3-4 months post intervention|4 months from baseline||||minutes||Inter-Quartile Range|Median
2622471|NCT01939405|Primary|Moderate to Vigorous Physical Activity (MVPA)|Short-term change in MVPA from baseline to post-intervention|Immediately post-intervention||||minutes||Inter-Quartile Range|Median
2622472|NCT01939366|Primary|Change in Average Pain Intensity.|"Participants will be asked to record their pain intensity in the evening. Participants are asked to rate how much pain they had on average in the past 24 hours. The participant scores their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Baseline average pain scores are calculated from the averages of all scores recorded during the 3 days prior to randomization. The average pain at week 6 will be the average pain scores calculated from all pain scores measured during week 6."|Baseline; to End of Week 6 of the Maintenance Phase|Full Analysis Set (FAS). Mixed-effects model for repeated measures (MMRM).|||units on a scale||95% Confidence Interval|Least Squares Mean
2622473|NCT01939314|Secondary|Headache Free at 24 Hours|The percentage of patients that were headache free at 24 hours by follow-up phone conversation.|24 hours||||percentage of participants|||Number
2622474|NCT01939314|Secondary|Categorical Pain Relief|"Categorical Pain Relief at 15 minutes. Participants were asked to categorize their pain relief at 15 minutes as No, Little, Some, A Lot or Complete. The table displays the number of participants who identified their pain relief in the categories provided."|15 minutes from dose||||participants|||Number
2622475|NCT01939314|Primary|Number of Participants Who Reported a 50% or Greater Reduction in Pain at 15 Minutes as Measured on the 100mm Visual Analog Scale||15 minutes from dose||||percentage of participants|||Number
2622476|NCT01939301|Primary|Number of Participants With Normal Right Ventricular (RV) Function and Viability|Right ventricular (RV) function and viability assessed by the composite of normal RV size (<42 mm in diastole) and tricuspid annular plane systolic excursion (TAPSE) > 16 mm and normal right ventricular index of myocardial performance (RIMP) < 0.40 using spectral Doppler or < 0.55 using tissue Doppler) and normal fractional area change (FAC) (> 33%) and a serum hsTnT < 14pg/mL. Missing values will be considered normal.|5 days or hospital discharge (whichever occurs first)||||Participants|||Count of Participants
2622477|NCT01939288|Other Pre-specified|NMES(on) Peak Velocity Change From Baseline||One day||||cm/s||Inter-Quartile Range|Median
2622478|NCT01939288|Primary|IPC(on) Peak Velocity Change From Baseline|Ultrasound measurements of peak velocity. This is taken from the left leg superficial femoral vein and artery|One day||||cm/s||Inter-Quartile Range|Median
2622479|NCT01939275|Primary|Number of HER2 Negative, Positive, or Equivocal Participants With Either Negative or Positive Tumor Readings|"The reading of the 64CuDOTA-trastuzumab-PET imaging of the study subjects were performed by two radiologists, one who read the first scan and the second nuclear radiologist read the remaining seven scans. To eliminate potential bias, the second nuclear radiologist was blinded to the HER2 status of the tumors as well as the location of the tumor until radiolabeled uptake was measured. XD (version 3.6; Miranda Medical) was used for image analysis.Tumor visualized as hot relative to adjacent tissue reported per radiologist as negative, positive, equivocal or unknown."|Up to 1 year||||participants|||Number
2622480|NCT01939223|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time (days) from randomization to death due to any cause. The OS time for subjects alive at the time of analysis was censored at their last date known to be alive.|Subjects who experienced disease recurrence (either during treatment or during Active Follow-up), or otherwise withdrew from the study for any reason other than death, were followed for overall survival unless consent was withdrawn.|Number of Participants Analyzed is 0 because this study was prematurely terminated and data were not collected for this endpoint.||||||
2622481|NCT01939223|Primary|Disease Free Survival (DFS) as Assessed by the Investigator|Disease free survival was evaluated by CT / MRI scans as assessed by the investigator, which was defined as the time (in days) from date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented. For subjects without documented disease recurrence or death at the time of analysis, the DFS time was censored at the date of the last evaluable CT / MRI scan.|From date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented.|Number of Participants Analyzed is 0 because this study was prematurely terminated and data were not collected for this endpoint.||||||
2622600|NCT01938378|Secondary|Assessment of Mean Ionized Calcium Levels|Blood samples compare levels before each TPE (therapeutic plasma exchange), during each TPE, and after each TPE. Pre-TPE is within 24 hours before TPE start; Follow-Up is 24 (+/-2) hours after TPE end.|up to 8 days including the 24 hour follow-up|Not all patients received blood draws/multiple TPEs|||mmol/L||Standard Deviation|Mean
2622482|NCT01939197|Secondary|Percentage of Participants in Part 2 With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment|HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL).|End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126)|Intent-to-treat population: Part 2 randomized or enrolled participants in the GT1 analysis group (and its composing arms) and GT4 analysis group who received at least 1 dose of study drug. Due to a label change after study start that no longer recommended the Arm G treatment regimen to GT1b cirrhotic subjects, Arm G data was not analyzed.|||percentage of participants||95% Confidence Interval|Number
2622483|NCT01939197|Secondary|Percentage of Participants in Part 1b With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment|HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL).|End of treatment: HIV Week 12 window (Treatment Day 78 - 98). PTW12: HIV PTW12 window (Post-Treatment Day 57 - 126)|Intent-to-treat population: Part 1b randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2622484|NCT01939197|Secondary|Percentage of Participants in Part 1a With Plasma HIV-1 RNA Suppression at End of Treatment and 12 Weeks Post-Treatment|HIV virologic success was defined as HIV-1 RNA suppression (HIV-1 RNA value < 40 copies/mL).|End of treatment: HIV Week 12 window for 12-weeks of treatment (Treatment Day 71 - 98) or HIV Week 24 window (Treatment Day 155 - 182) for 24-weeks of treatment. Post-Treatment Week 12 (PTW12): HIV PTW12 window (Post-Treatment Day 57 - 126)|Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2622485|NCT01939197|Secondary|Percentage of Participants in Part 2 With Relapse12|Percentage of participants who experienced Relapse12 among those who completed treatment with HCV RNA < LLOQ at final treatment visit and had ≥1 post-treatment HCV RNA value. Relapse12=confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 window) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data, excluding reinfection. Completion of treatment=study drug duration ≥ 77 days for participants who received 12 weeks of treatment and ≥154 days for participants who received 24 weeks of treatment. HCV reinfection=confirmed HCV RNA ≥ LLOQ after the end of treatment in a subject who had HCV RNA < LLOQ at final treatment visit, along with the post-treatment detection of a different HCV genotype, subtype, or clade compared with baseline, as determined by phylogenetic analysis. The 95% CI is calculated using Wilson score method for the binomial distribution.|up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug|Intent-to-treat population: Part 2 randomized or enrolled participants in the GT1 analysis group (and its composing arms) and GT4 analysis group who received ≥1 dose of study drug, who completed treatment with HCV RNA < LLOQ at final treatment visit, and had ≥1 post-treatment HCV RNA value. Arm G data was not analyzed (see Outcome Measure 8).|||percentage of participants||95% Confidence Interval|Number
2622486|NCT01939197|Secondary|Percentage of Participants in Part 1b With Relapse12 for Each Arm and Overall|Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm C and Arm D. The 95% CI is calculated using Wilson score method for the binomial distribution.|up to 12 weeks after the last actual dose of study drug|Intent-to-treat population: all Part 1b randomized participants who received at least 1 dose of study drug and who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value.|||percentage of participants||95% Confidence Interval|Number
2622487|NCT01939197|Secondary|Percentage of Participants in Part 1a With Relapse12|Percentage of participants who experienced Relapse12 among participants who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value. Relapse12 is defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at final treatment visit who completed treatment and had post-treatment data. Completion of treatment is defined as study drug duration ≥ 77 days for Arm A and ≥ 154 days for Arm B. The 95% CI is calculated using Wilson score method for the binomial distribution.|up to 12 or 24 weeks, based on treatment duration, after the last actual dose of study drug|Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug and who completed treatment with HCV RNA < LLOQ at final treatment visit and had at least one post-treatment HCV RNA value.|||percentage of participants||95% Confidence Interval|Number
2622488|NCT01939197|Secondary|Percentage of Participants in Part 2 With On-Treatment HCV Virologic Failure During the Treatment Period|Percentage of participants with on-treatment HCV virologic failure during the treatment period for arms in Part 2. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.|up to 12 or 24 weeks, based on treatment duration|Intent-to-treat population: Part 2 randomized or enrolled participants in the GT1 analysis group (and its composing arms) and GT4 analysis group who received at least 1 dose of study drug. Due to a label change after study start that no longer recommended the Arm G treatment regimen to GT1b cirrhotic subjects, Arm G data was not analyzed.|||percentage of participants||95% Confidence Interval|Number
2622489|NCT01939197|Secondary|Percentage of Participants in Part 1b With On-Treatment HCV Virologic Failure During the Treatment Period|Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm and overall in Part 1b. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.|up to 12 weeks|Intent-to-treat population: Part 1b randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2622599|NCT01938378|Secondary|Investigator's Assessment of Overall Safety|Excellent: defined as the treatment was well tolerated by the patient; Moderate: defined as Adverse Drug Reaction (ADR(s)) were observed, but easily resolved or not clinically significant; Poor: defined as ADR(s) were observed requiring significant medical intervention|up to 8 days including the 24 hour follow-up|Not all patients received multiple TPEs|||Participants|||Count of Participants
2622490|NCT01939197|Secondary|Percentage of Participants in Part 1a With On-Treatment HCV Virologic Failure During the Treatment Period|Percentage of participants with on-treatment HCV virologic failure during the treatment period for each arm in Part 1a. Virologic failure is defined as confirmed quantifiable HCV RNA among participants with previously unquantifiable HCV RNA during treatment.|up to 12 or 24 weeks, based on treatment duration|Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2622491|NCT01939197|Secondary|Percentage of Participants With GT4 HCV in Part 2 Achieving SVR12, by Arm and Overall|SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.|12 weeks after last dose of study drug|Intent-to-treat population: Part 2 randomized or enrolled participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.|||percentage of participants||95% Confidence Interval|Number
2622492|NCT01939197|Secondary|Percentage of Participants in Arm F and Arm G of Part 2 Achieving SVR12|SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.|12 weeks after last dose of study drug|Intent-to-treat population: Part 2 randomized or enrolled participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.|||percentage of participants||95% Confidence Interval|Number
2622493|NCT01939197|Secondary|Percentage of Participants in Part 1b Achieving SVR12|SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.|12 weeks after last dose of study drug|Intent-to-treat population: Part 1b randomized participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.|||percentage of participants||95% Confidence Interval|Number
2622494|NCT01939197|Secondary|Percentage of Participants in Part 1a Achieving SVR12|SVR12 is defined as plasma HCV RNA < LLOQ 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% CI is calculated using the Wilson score method for binomial distribution.|12 weeks after last dose of study drug|Intent-to-treat population: Part 1a randomized participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures.|||percentage of participants||95% Confidence Interval|Number
2622495|NCT01939197|Primary|Percentage of Participants in GT1 Analysis Group 1 in Part 2 Achieving Sustained Virologic Response 12 Weeks Post-Treatment (SVR12)|"SVR12 is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval (CI) is calculated using the Wilson score method for binomial distribution.~The primary efficacy endpoint was the non-inferiority of the percentage of participants in the GT1 Analysis Group in Part 2 achieving SVR12 compared to the historical SVR12 rate for sofosbuvir plus ribavirin (a non-inferiority threshold of the lower bound of the 95% CI of 74%)."|12 weeks after the last actual dose of study drug|Intent-to-treat population: Part 2 randomized or enrolled participants who received at least 1 dose of study drug. Imputation applied; participants with missing HCV RNA data after imputation were counted as failures. The primary efficacy endpoint analysis was based on subjects in the GT 1 Analysis Group in Part 2 containing Arms E, F, H, I, and J.|||percentage of participants||95% Confidence Interval|Number
2622496|NCT01939145|Other Pre-specified|Bacterial Culture Results|Compare the qualitative bacterial culture results between Prontosan NPWTi and normal saline NPWTi.|Patients will be followed during their hospital stay which is an average of approximately 2 weeks.|||||||
2622497|NCT01939145|Other Pre-specified|Wound Recidivism|Compare the percent of wounds that remained closed 30 days and up to one year after discharge between Prontosan NPWTi and normal saline NPWTi.|30 days post discharge from hospital|||||||
2622498|NCT01939145|Other Pre-specified|Time to Closure|Compare the percent of wounds closed and the time to closure during the hospital admission and up to one year after discharge between Prontosan NPWTi and normal saline NPWTi.|Patients will be followed during their hospital stay which is an average of approximately 2 weeks.|||||||
2622499|NCT01939145|Secondary|Hospital Admission Length of Stay|Compare the hospital admission length of stay between Prontosan NPWTi and normal saline NPWTi.|Patients will be followed during their hospital stay which is an average of approximately 2 weeks.||||days||Standard Deviation|Mean
2622500|NCT01939145|Primary|Number of Operating Room Visits|Compare the number of operative room visits between Prontosan NPWTi and normal saline NPWTi.|Patients will be followed during their hospital stay which is an average of approximately 2 weeks.||||Operative Room Visits||Standard Deviation|Mean
2622501|NCT01939002|Secondary|Antibody Data in the Overall Population: IFN β-1a Neutralizing Antibodies (Nabs) Testing|The number of participants who tested positive for IFN β-1a Nabs. Value was coded as 'positive' if observed value > 0 or coded as 'negative' if observed value < 0. This secondary endpoint was targeted to analyze the Overall Population only.|Baseline (Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)|Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.|||participants|||Number
2622502|NCT01939002|Secondary|Antibody Data in the Overall Population: IFN β-1a Anti-Pegylated (PEG) Antibody Testing|The number of participants who tested positive or negative for IFN β-1a anti-PEG antibodies. Value was coded as 'positive' if observed value > 0 or coded as 'negative' if observed value < 0. This secondary endpoint was targeted to analyze the Overall Population only.|Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)|Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.|||participants|||Number
2625897|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||mmol/L||Standard Deviation|Mean
2622503|NCT01939002|Secondary|Antibody Data in the Overall Population: IFN β-1a Antibody Screening|The number of participants who tested positive for IFN β-1a binding antibodies (BAbs). Value was coded as 'positive' if observed value > 0 or coded as 'negative' if observed value < 0. This secondary endpoint was targeted to analyze the Overall Population only.|Baseline (BL; Day 1), Week 12, Week 24, Week 36, Week 48 or early withdrawal (EW)|Safety population: participants who received at least 1 injection of study treatment and had an assessment; n=number of participants with an assessment at given timepoint.|||participants|||Number
2622504|NCT01939002|Secondary|Summary of Average Duration of FLS Within the Last 4 Weeks of the BIIB017 Treatment Period Compared With the Duration of FLS in the 4-Week Run-In Period|Average duration of FLS for the last 4 weeks (L4W) is defined as the mean duration of last 4 weeks. Duration of FLS for a treatment is defined as the sum of hours from the treatment to 48 hours with a FLS-S score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is > 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. 4WRI=4-week run-in.|Weeks -4 to -1 (Screening), Weeks 45-48 (last 4 weeks of study)|Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and had FLS; n=number of participants assessed at the given timepoint.|||hours||Standard Deviation|Mean
2622505|NCT01939002|Secondary|Summary of Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs|An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could jeopardize the subject or could require intervention to prevent one of the other outcomes listed in the definition above. ISR=injection site reactions.|Day 1 to Week 52|Safety population: all participants who received at least 1 injection of study treatment.|||participants|||Number
2622506|NCT01939002|Secondary|Change From Baseline Visit (Day 1) to Week 48 in Walking Disability Status as Measured by Patient Determined Disease Steps (PDDS): Overall Population|Subjects rated their perceived walking disability on a scale of 0 to 8 using the PDDS, with higher scores indicating more severe disability. This secondary endpoint was targeted to analyze the Overall Population only.|Day 1 (Baseline, pre-dose), Week 12, Week 48, Early Termination|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
2622507|NCT01939002|Secondary|Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Treatment: Overall Population|Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from MS symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.|Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination|Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and were employed; n=number of participants assessed at the given timepoint.|||days||Standard Deviation|Mean
2622508|NCT01939002|Secondary|Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Days Missed in 2 Weeks From MS Symptoms: Overall Population|Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from MS symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.|Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination|Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and were employed; n=number of participants assessed at the given timepoint.|||days||Standard Deviation|Mean
2622509|NCT01939002|Secondary|Mean Change From Screening at Each Visit in Absenteeism Questionnaire, Usual Work Days Per Week: Overall Population|Categorical questions in the Absenteeism Questionnaire asked participants to report the number of usual work days per week, the number of days missed in 2 weeks from multiple sclerosis (MS) symptoms, and the number of days missed in 2 weeks from MS treatment. This secondary endpoint was targeted to analyze the Overall Population only. 4WRI=4-week run-in.|Week -4 (screening), Week 12, Week 24, Week 36, Week 48, Early Termination|Efficacy population: randomized participants who received at least 1 dose of study treatment, had efficacy data in both the 4-week run-in period and the post-baseline treatment period, and were employed; n=number of participants assessed at the given timepoint.|||days||Standard Deviation|Mean
2622510|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Global Satisfaction Scale Factor: Between FLS Management Arms|The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for global satisfaction (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.|4-week run-in period, Week 4|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
2622520|NCT01939002|Secondary|Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment|Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
2622511|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Convenience Scale Factor: Between FLS Management Arms|The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for convenience (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.|4-week run-in period, Week 4|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
2622512|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Side Effects Scale Factor: Between FLS Management Arms|The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for side effects (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.|4-week run-in period, Week 4|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
2622513|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Week 4 for TSQM, Effectiveness Scale Factor: Between FLS Management Arms|The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to Week 4 using transformed scores between 0 and 100 for effectiveness (with higher scores indicating greater satisfaction) are presented. This secondary endpoint was targeted for Week 4 only. 4WRI=4-week run-in.|4-week run-in period, Week 4|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
2622514|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Global Satisfaction Scale Factor: Overall Population|The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for global satisfaction (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.|4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
2622515|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Convenience Scale Factor: Overall Population|The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for convenience (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.|4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
2622516|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Each Visit for TSQM, Side-Effects Scale Factor: Overall Population|The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for side effects (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.|4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
2622517|NCT01939002|Secondary|Mean Change From 4-Week Run-In Period at Each Visit for Treatment Satisfaction Questionnaire for Medication (TSQM), Effectiveness Scale Factor: Overall Population|The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience. Changes from the 4-week run-in period to each visit using transformed scores between 0 and 100 for effectiveness (with higher scores indicating greater satisfaction) are presented. 4WRI=4-week run-in.|4-week run-in period, Weeks 4, 12, 24, 36, 48 (or Early Termination)|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
2622518|NCT01939002|Secondary|Percentage of Participants Requiring Additional FLS Management Regimen to Relieve BIIB017-related FLS||during the first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of subjects assessed at the given timepoint.|||percentage of participants|||Number
2622519|NCT01939002|Secondary|Summary of FLS-VAS During the 48 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment|Participants reported their satisfaction with the effectiveness of their FLS management regimen on a 100-mm VAS between not satisfied (0) and very satisfied (100). 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
2622576|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 20||Week 20|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.|||percentage of participants|||Number
2622521|NCT01939002|Secondary|Summary of FLS-VAS During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Satisfaction With FLS Treatment|Participants reported their satisfaction with the effectiveness of their FLS management regimen on a 100-mm VAS between not satisfied (0) and very satisfied (100). 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
2622522|NCT01939002|Secondary|Summary of FLS-Visual Analogue Scale (VAS) During the First 8 Weeks of Treatment Compared to 4-Week Run-In Period: Effectiveness of FLS Treatment|Participants reported the effectiveness of their FLS management regimen on a 100-mm VAS between not effective (0) and very effective (100). 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of participants assessed at the given timepoint.|||units on a scale||Standard Deviation|Mean
2622523|NCT01939002|Secondary|Summary of Average Duration of FLS in the 48 Weeks of Treatment|Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with a FLS-S score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If a FLS is > 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of subjects assessed at the given timepoint.|||hours||Full Range|Median
2622524|NCT01939002|Secondary|Summary of Average Duration of FLS in the First 8 Weeks of Treatment|Duration of FLS for a treatment was defined as the sum of hours from the time of treatment to 48 hours with an FLS-S score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. If an FLS is > 0 at an evaluation time, 6 hours were counted as the duration assuming the event started from previous evaluation time. Average duration of FLS for the first 8 weeks was defined as the mean duration from Weeks 0, 2, 4, 6, and 8. 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period; n=number of subjects assessed at the given timepoint.|||hours||Full Range|Median
2622525|NCT01939002|Secondary|Summary of Severity of FLS (Per FLS-S) in the 48 Weeks of Treatment Compared to 4-Week Run-In Period Between Arms|The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.|||units on a scale||Standard Deviation|Mean
2622526|NCT01939002|Secondary|Summary of Severity of FLS (Per FLS-S) in the First 8 Weeks Compared to 4-Week Run-In Period Between Arms|The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.|||units on a scale||Standard Deviation|Mean
2622527|NCT01939002|Secondary|Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to 48 Weeks|Any FLS is defined as an FLS-S total score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; 48W=48 weeks.|4-week run-in period, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.|||percentage of participants|||Number
2622528|NCT01939002|Secondary|Shift in Percentage of Participants With Any FLS From 4-Week Run-In Period to the First 8 Weeks|Any FLS is defined as an FLS-S total score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. Pre-dose data not were used. Data up to 48-hours after dosing were used. Total score was imputed as the highest score after dose. 4WRI=4-week run-in period; F8W=first 8 weeks.|4-week run-in period, first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.|||percentage of participants|||Number
2622529|NCT01939002|Secondary|Percentage of Participants With Any FLS in the 4-Week Run-In Period, During the First 8 Weeks of Treatment, and During 48 Weeks of Treatment|Any FLS is defined as an FLS-S total score > 0. The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. 4WRI=4-week run-in; F8W=first 8 weeks; 48W=48 weeks.|4-week run-in period, first 8 weeks of treatment, 48 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.|||percentage of participants|||Number
2622577|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 16||Week 16|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.|||percentage of participants|||Number
2622530|NCT01939002|Secondary|Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Between FLS Management Arms|The total FLS-S is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.|during the first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.|||percentage of participants|||Number
2622531|NCT01939002|Primary|Percentage of Participants Experiencing New or Increased FLS During the First 8 Weeks: Overall Population|The total Flu-like Symptoms Score (FLS-S) is the sum of all 4 symptom scores (muscle aches, chills, fatigue and fever), each rated from 0 (absent) to 3 (severe), with a range of 0-12 with 0 indicating no FLS and 12 indicating severe FLS. New or increased FLS is defined as an FLS overall score of 2 points or greater over Screening. Pre-dose data were not used; up to 48-hour data after dosing were used. Overall score was imputed as the average score after dose.|during the first 8 weeks of treatment|Efficacy population: randomized participants who received at least 1 dose of study treatment and had efficacy data in both the 4-week run-in period and the post-baseline treatment period.|||percentage of participants|||Number
2622532|NCT01938989|Primary|Photostress Recovery Time|Photostress Recovery Time is the time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source. The subject fixated on an image (black and white grating) and underwent photostress (glare) for 5 seconds. Only 1 eye (study eye) was assessed.|Day 1|This analysis population includes all participants with observation minus any major protocol deviations.|||seconds||Standard Deviation|Mean
2622533|NCT01938846|Secondary|Maximum Measured Concentration of BI 860585 in Plasma at Steady State (Cmax,ss)|Cmax,ss, maximum measured concentration at steady state after multiple administration of BI 860585 (Day 22) in BI 860585 monotherapy and in combination with exemestane and paclitaxel.|Pharmacokinetic samples were collected at pre-dose and at 504.5, 505, 506, 507, 508, 510, 512, 527.917 hours after drug administration.|PKS|||nanomol/ Litre [nmol/L]||Geometric Coefficient of Variation|Geometric Mean
2622534|NCT01938846|Secondary|Time to Maximum Concentration of BI 860585 at Steady State (Tmax,ss)|tmax,ss, Time to maximum concentration of BI 860585 at steady state after multiple administration of BI 860585 (Day 22) in BI 860585 monotherapy and in combination with exemestane and paclitaxel.|Pharmacokinetic samples were collected at pre-dose and at 504.5, 505, 506, 507, 508, 510, 512, 527.917 hours after drug administration.|PKS|||Hour (h)||Full Range|Median
2622535|NCT01938846|Secondary|Half Life of BI 860585 at Steady State (t1/2,ss)|t1/2,ss, half-life of BI 860585 in plasma at steady state after multiple administration of BI 860585 (Day 22) in BI 860585 monotherapy and in combination with exemestane and paclitaxel.|Pharmacokinetic samples were collected at pre-dose and at 504.5, 505, 506, 507, 508, 510, 512, 527.917 hours after drug administration.|PKS|||Hour (h)||Geometric Coefficient of Variation|Geometric Mean
2622536|NCT01938846|Secondary|Area Under the Concentration-time Curve of BI 860585 in Plasma Over a Dosing Interval at Steady State (AUCτ,ss)|AUCτ,ss, area under the concentration-time curve of BI 860585 in plasma over the dosing interval at steady state after multiple administration of BI 860585 (Day 22) in BI 860585 monotherapy and in combination with exemestane and paclitaxel.|Pharmacokinetic samples were collected at pre-dose and at 504.5, 505, 506, 507, 508, 510, 512, 527.917 hours after drug administration.|PKS|||nanomol*hour/ Litre [nmol*h/L]||Geometric Coefficient of Variation|Geometric Mean
2622537|NCT01938846|Secondary|Time to Maximum Concentration of BI 860585 (Tmax)|Tmax, Time to maximum concentration of BI 860585 in plasma over a dosing interval after single administration of BI 860585|Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585.|PKS|||Hour (h)||Full Range|Median
2622538|NCT01938846|Secondary|Maximum Measured Concentration of BI 860585 (Cmax)|Cmax, maximum measured concentration of BI 860585 in plasma over a dosing interval after single administration of BI 860585|Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585.|PKS|||nanomole/Litre [nmol/L]||Geometric Coefficient of Variation|Geometric Mean
2622539|NCT01938846|Secondary|Half Life of BI 860585 (t1/2)|t ½, half-life of BI 860585 in plasma over a dosing interval after single administration of BI 860585|Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585.|PKS|||Hour (h)||Geometric Coefficient of Variation|Geometric Mean
2622540|NCT01938846|Secondary|Area Under the Concentration-time Curve in Plasma of BI 860585 Over the Time Interval From 0 to 24 Hours (AUC0-24)|AUC0-24, area under the concentration-time curve in plasma of BI 860585 over the time interval from 0 to 24 hours after single administration of BI 860585|Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585.|PKS|||nanomol*hour/ Litre [nmol*h/L]||Geometric Coefficient of Variation|Geometric Mean
2622541|NCT01938846|Secondary|Area Under the Concentration-time Curve in Plasma of BI 860585 Over the Time Interval From 0 to Infinity (AUC0-∞)|AUC0-∞, area under the concentration-time curve in plasma of BI 860585 over the time interval from 0 to infinity after single administration of BI 860585|Pharmacokinetic samples were collected at pre-dose and 0.5, 1, 2, 3, 4, 6, 8 and 23.917 hours after administration of BI 860585.|Pharmacokinetic Analysis Set (PKS): This patient set includes all evaluable patients in the treated set (TS) which provide at least one observation for at least one pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK.|||nanomol*hour/ Litre [nmol*h/L]||Geometric Coefficient of Variation|Geometric Mean
2622542|NCT01938846|Secondary|Duration of Objective Response|Duration of objective response was defined as the time from first objective response until the earliest of progression or death, for patients with objective response.|From the date of first treatment administration until the earliest of disease progression, death, or last adequate tumour assessment before new anti-cancer therapy; data collected up to cut-off date 30 Jun 2017, Up to 1389 days|Patients with objective response from the treated set (Treated Set: The treated set includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane or paclitaxel)).|||Months||Standard Deviation|Mean
2622543|NCT01938846|Secondary|Duration of Clinical Benefit|Duration of clinical benefit (Disease control) was defined as the time between first treatment administration until the earliest of disease progression or death, for patients with disease control.|From the date of first treatment administration until the earliest of disease progression, death, or last adequate tumour assessment before new anti-cancer therapy; data collected up to cut-off date 30 Jun 2017, Up to 1389 days|Patients with disease control from the treated set (Treated Set: The treated set includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane or paclitaxel)).|||Months||Standard Deviation|Mean
2622544|NCT01938846|Secondary|Disease Control Rate/Clinical Benefit Rate (Complete Response, Partial Response or Stable Disease as Per Response Evaluation Criteria In Solid Tumors Criteria [RECIST], Version 1.1)|As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for disease control rate/clinical benefit rate (Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression) for target lesions assessed by Magnetic resonance imaging (MRI) and Computed tomography (CT)|From the date of first treatment administration until the earliest of disease progression, death, or last adequate tumour assessment before new anti-cancer therapy.|Treated Set: The treated set includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane or paclitaxel).|||Participants|||Count of Participants
2622545|NCT01938846|Secondary|Objective Response Rate (Complete Response or Partial Response as Per the Response Evaluation Criteria In Solid Tumors Criteria [RECIST], Version 1.1)|As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for objective response rate (Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions) for target lesions assessed by Magnetic resonance imaging (MRI) and Computed tomography (CT)|From the date of first treatment administration until the earliest of disease progression, death, or last adequate tumour assessment before new anti-cancer therapy; data collected up to cut-off date 30 Jun 2017, Up to 1389 days|Treated Set: The treated set includes all patients who were administered at least one dose of any study medication (BI 860585, exemestane or paclitaxel).|||Participants|||Count of Participants
2622546|NCT01938846|Primary|The Maximum Tolerated Dose (MTD) for Each Treatment Arm|The Maximum Tolerated Dose (MTD) for each treatment arm was the dose that was 1 dose cohort below that at which ≥2 of 6 patients had experienced DLT. i.e., the MTD was the highest dose studied for which the DLT incidence was no more than 17% (i.e. 1 of 6 patients) during the first treatment course.|28 days (Maximum tolerated dose (MTD) evaluation period (First Treatment Cycle))|Treated and Evaluable Set: The treated and evaluable set includes all patients who were administered at least one dose of study medication and who are evaluable with respect to DLT in the MTD evaluation period.|||Milligram (mg)|||Number
2622547|NCT01938846|Primary|The Number of Patients With Dose-Limiting Toxicities (DLTs) in the First Course of Each Treatment Arm|The number of patients with Dose-Limiting Toxicities (DLTs) in the first course of each treatment arm to identify the Maximum Tolerated Dose (MTD) for BI 860585 monotherapy and BI 860585 in combination with exemestane of paclitaxel.|28 days (Maximum tolerated dose (MTD) evaluation period (First Treatment Cycle))|Treated and Evaluable Set: The treated and evaluable set includes all patients who were administered at least one dose of study medication and who are evaluable with respect to DLT in the MTD evaluation period.|||Participants|||Count of Participants
2622548|NCT01938833|Secondary|Clinical Benefit Rate (CBR)|The 95% confidence intervals should be provided.|Up to 5 years|Data were not collected and the Outcome will never be analyzed.||||||
2622549|NCT01938833|Secondary|Overall Response Rate (ORR)|The 95% confidence intervals should be provided.|Up to 5 years|Data were not collected and the Outcome will never be analyzed.||||||
2622550|NCT01938833|Secondary|Incidence of Adverse Events, Graded According to NCI CTCAE Version 4.0|Summary tables of grade 2, 3, and 4 toxicities, adverse events (AE), and serious adverse events (SAE) will be generated at the conclusion of the study as well as at the conclusion of phase I study and after 15 patients have been collected on at the interim evaluation time point of the phase 2 part of the study.|Up to 30 days|Data were not collected and the Outcome will never be analyzed.||||||
2622551|NCT01938833|Primary|Progression-Free Survival (PFS)||The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years|Data were not collected and the Outcome will never be analyzed||||||
2622552|NCT01938833|Primary|Maximum-Tolerated Dose of Romidepsin (Phase I)|Determined according to incidence of dose-limiting toxicity, graded using the National Cancer Institute (NCI) CTCAE version 4.0|28 days|Data were not collected and the Outcome will never be analyzed.||||||
2622553|NCT01938664|Secondary|# of Participants With Adverse Events|Candesartan will be well tolerated without significant side effects.|8 weeks||||participants|||Number
2622554|NCT01938664|Secondary|# of Participants Retained in Study||8 weeks||||participants|||Number
2622555|NCT01938664|Primary|# of Participants With Presence of Cocaine Metabolites Via Urinalysis||thrice weekly, baseline thru week 8||||participants|||Number
2622556|NCT01938625|Secondary|Number of Participants With Viral Relapse|Participants who did not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up.|Up to Week 24 after actual EOT (week 24)|Intent to treat (ITT) analysis set included all enrolled participants who took at least 1 dose of investigational medication.|||participants|||Number
2622557|NCT01938625|Secondary|Number of Participants With Viral Breakthrough|Viral breakthrough is defined as a confirmed increase of >1 log10 IU/mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of >100 IU/mL in participants whose HCV RNA levels had previously been below the limit of quantification (<25 IU/mL detectable) or undetectable (<25 IU/mL undetectable) while on study treatment.|Up to week 24|ITT analysis set included all enrolled participants who took at least 1 dose of investigational medication.|||participants|||Number
2622578|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2622579|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2622558|NCT01938625|Secondary|Number of Participants With On-Treatment Failure|On-treatment failure is defined as participants who did not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of treatment. This was to include participants with: 1) Viral breakthrough, defined as a confirmed increase of greater than (>)1 log10 in HCV RNA from nadir, or confirmed HCV RNA of >100 IU/mL in participants whose HCV RNA had previously been <lower limit of quantification (LLOQ) while on treatment; 2) Other with confirmed detectable HCV RNA at the actual end of treatment (example, completed, discontinued due to adverse events (AEs), withdrawal of consent).|Up to Week 24 after actual EOT (week 24)|ITT analysis set included all enrolled participants who took at least 1 dose of investigational medication.|||participants|||Number
2622559|NCT01938625|Secondary|Percentage of Participants With HCV RNA (<) 100 IU/mL at Week 4|Percentage of participants with HCV RNA (<) 100 IU/mL at week 4 were reported.|Week 4|ITT analysis set included all enrolled participants who took at least 1 dose of investigational medication.|||percentage of participants|||Number
2622560|NCT01938625|Secondary|Percentage of Participants With HCV RNA (< 25 IU/mL Undetectable) and HCV RNA < 25 IU/mL Detectable|Percentage of participants with detectable and undetectable HCV RNA (<) 25 IU/mL during treatment at Weeks 2,4, 12, and 24 were reported.|Weeks 2, 4, 12, and 24|ITT analysis set included all enrolled participants who took at least 1 dose of investigational medication.|||percentage of participants|||Number
2622561|NCT01938625|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After the End of Treatment (SVR 24)|Participants were considered to have achieved SVR 24 if hepatitis C virus ribonucleic acid (HCV RNA) levels were (<) 25 IU/mL detectable or undetectable at 24 weeks after the end of treatment.|Week 48|ITT analysis set included all enrolled participants who took at least 1 dose of investigational medication.|||percentage of participants||95% Confidence Interval|Number
2622562|NCT01938625|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After the End of Treatment (SVR 4)|Participants were considered to have achieved SVR4 if HCV RNA levels were (<) 25 IU/mL detectable or undetectable at 4 weeks after the end of treatment.|Week 28|ITT analysis set included all enrolled participants who took at least 1 dose of investigational medication.|||percentage of participants||95% Confidence Interval|Number
2622563|NCT01938625|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After the End of Treatment (SVR 12)|Participants were considered to have achieved SVR12 if hepatitis C virus ribonucleic acid (HCV RNA) levels were less than (<) 25 international unit per milliliter (IU/mL) detectable or undetectable at 12 weeks after the end of treatment.|Week 36|Intent to treat (ITT) analysis set included all enrolled participants who took at least 1 dose of investigational medication.|||percentage of participants||95% Confidence Interval|Number
2622564|NCT01938573|Secondary|Incidence of Adverse Events Including Any Unfavorable and Unintended Sign, Symptom, Diagnosis, or Disease Temporally Associated With the Use of a Medicinal Product, Whether or Not Related to the Medicinal Product (Phase I and II)|Graded according to the NCI CTCAE version 4.0. Safety will be assessed through summaries of adverse events, vital signs, physical examinations, and clinical laboratory test data (including change from baseline). All adverse events resulting in discontinuation, dose modification, dosing interruption, and/or treatment delay of study drug will also be listed and tabulated by preferred term.|Up to 28 days after completion of study treatment||||Number of events|||Number
2622565|NCT01938573|Primary|Percent of Patients With Pathologic Complete Response (Phase II)|The study will follow an optimal two-stage Simon design based on pathologic complete response rate.|12 weeks|Patients treated in phase 2|||Participants|||Count of Participants
2622566|NCT01938573|Primary|Patients With Dose Limiting Toxicity|Safety will be assessed through summaries of adverse events, vital signs, physical examinations, and clinical laboratory test data (including change from baseline).|Up to 28 days||||Participants|||Count of Participants
2622567|NCT01938430|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score|CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline.|Baseline to Posttreatment Week 4|Full Analysis Set. Cirrhotic participants were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.|||percentage of participants|||Number
2622568|NCT01938430|Secondary|Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score|Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.|Baseline to Posttreatment Week 4|Full Analysis Set. Participants with cirrhosis were analyzed if they had measurements at both baseline and Posttreatment Week 4. Only groups with cirrhotic participants are presented.|||percentage of participants|||Number
2622569|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 12||Baseline; Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2622570|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2622571|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2622572|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2622573|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2622574|NCT01938430|Secondary|HCV RNA and Change From Baseline at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2622575|NCT01938430|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 24||Week 24|Participants in the Full Analysis Set who were randomized to a 24-week treatment group and had available data were analyzed. 12-week treatment groups (did not collect data past Week 12) are not presented in this table.|||percentage of participants|||Number
2622584|NCT01938430|Secondary|Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12|pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant.|Posttransplant Week 12|Participants who had a liver transplant while on study were analyzed if their last observed HCV RNA measurement prior to transplant was < LLOQ. Participants who received a transplant from an HCV-infected donor were excluded from analysis.|||percentage of participants|||Number
2622585|NCT01938430|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set. Participants were excluded from the analysis if they received a liver transplant while on study (with HCV RNA <LLOQ at transplant) prior to lower bound of Posttreatment Week 12 visit window.|||percentage of participants|||Number
2622586|NCT01938430|Secondary|Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)|SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.|Posttreatment Week 24|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 24 visit were not included in the analysis.|||percentage of participants|||Number
2622587|NCT01938430|Secondary|Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)|SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment.|Posttreatment Week 8|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 8 visit were not included in the analysis.|||percentage of participants|||Number
2622588|NCT01938430|Secondary|Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)|SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.|Posttreatment Week 4|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 4 visit were not included in the analysis.|||percentage of participants|||Number
2622589|NCT01938430|Secondary|Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)|SVR2 was defined as HCV RNA < LLOQ at 2 weeks after stopping study treatment.|Posttreatment Week 2|Full Analysis Set. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 2 visit were not included in the analysis.|||percentage of participants|||Number
2622590|NCT01938430|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least one dose of study drug|||percentage of participants|||Number
2622591|NCT01938430|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least one dose of study drug. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 12 visit were not included in the analysis.|||percentage of participants|||Number
2622592|NCT01938391|Primary|Percent (%) Area Stenosis|Percentage (%) of area stenosis as assessed by the intravascular ultrasound (IVUS) Core Lab. Percentage of area stenosis was calculated as 1 - (minimum lumen area / reference lumen area).|Index Procedure (pre-procedure, post-OAS treatment and post-balloon treatment)|At the time of analysis 24 of 29 lesions in 25 participants could be assess by the IVUS Core Lab.|||percent area stenosis|lesions|Inter-Quartile Range|Median
2622593|NCT01938391|Primary|Stent Usage at the Time of the Index Procedure|Number of lesions with a stent placed during the index procedure.|Index Procedure|Number of stents placed is based on number of lesions treated in the total subject population of 25. The total number of lesions treated were 29 and of those 29 lesions, 17 had a stent placed.|||Lesions|Lesions||Number
2622594|NCT01938391|Primary|Rutherford Classification (RC)|"Rutherford Classification (RC) is a commonly used clinical grading system for describing peripheral arterial disease (PAD) on a scale of 0 to 6. RC 6 is the most severe form of PAD. The RC is assessed for each participant at baseline and at each follow-up visit.~RC classification is as follows:~RC 0: Asymptomatic, no hemodynamically significant occlusive disease RC 1-3: Mild to Severe Claudication, limitation with ordinary physical activities, patient is comfortable at rest RC 4-5: Ischemic rest pain, minor tissue loss, non healing ulcer, focal gangrene RC 6: Major tissue loss, functional foot no longer salvageable"|Baseline, 2 weeks, 6 month and 12 month|At the time of analysis for the 6 month visit 1 participant missed their follow up visit. At the time of analysis for the 12 month visit, 22 participants completed the 12 month follow up visit.|||Participants|||Count of Participants
2622595|NCT01938391|Primary|Ankle-Brachial Index (ABI) Measurments|The ankle-brachial index (ABI) is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial (upper arm) artery. Normal range of ABI is 0.9 - 1.2. Values less than 0.9 suggests presence of peripheral artery disease (PAD). Values greater than 1.2 suggests of non-compressible vessel.|Baseline, 2 weeks, 6 months and 12 months|At the time of this analysis 3 of the subjects did not have their ABI measured at baseline, 1 participant did not have their ABI measured at 2 weeks, 1 participant did not have their ABI measured at 6 months and 1 participant did not have their ABI measured at 12 months.|||ratio||Standard Deviation|Mean
2622596|NCT01938391|Primary|Rate of Procedural Angiographic Complications|Percent of study participants with an Investigator reported procedural angiographic complication (flow limiting dissection, perforation, slow flow/no flow, distal embolization and recoil).|Index Procedure||||Participants|||Count of Participants
2622597|NCT01938391|Primary|Mean Maximum Balloon Inflation Pressure|Mean maximum balloon inflation pressure of balloons used pre-stent placement.|Index Procedure||||atm|balloons|Standard Deviation|Mean
2622598|NCT01938391|Primary|Rate of Clinically Driven Target Lesion Revascularization (TLR)|A Kaplan-Meier analysis was performed to determine the percent probability that a study participant had a TLR at 6 months and at 12 months.|6 months and 12 months||||% probablity of clinically driven TLR||95% Confidence Interval|Number
2622847|NCT01935180|Secondary|Real Time Prediction of Polyp Histology|Difference in recommended surveillance interval between real time polyp diagnosis and pathological diagnosis among patients with at least one diminutive polyp|duration of colonoscopy||||Participants|||Count of Participants
2622601|NCT01938378|Secondary|Assessment of Mean Red Cell Distribution Width Levels|Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.|up to 8 days including the 24 hour follow-up|Not all patients received blood draws/multiple TPEs|||% red blood cell variation volume/size||Standard Deviation|Mean
2622602|NCT01938378|Secondary|Assessment of Mean Corpuscular Hemoglobin Concentration Levels|Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.|up to 8 days including the 24 hour follow-up|Not all patients received blood draws/multiple TPEs|||g/dL||Standard Deviation|Mean
2622603|NCT01938378|Secondary|Assessment of Mean Corpuscular Hemoglobin Levels|Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.|up to 8 days including the 24 hour follow-up|Not all patients received blood draws/multiple TPEs|||pg||Standard Deviation|Mean
2622604|NCT01938378|Secondary|Assessment of Mean Corpuscular Volume Levels|Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.|up to 8 days including the 24 hour follow-up|Not all patients received blood draws/multiple TPEs|||fL||Standard Deviation|Mean
2622605|NCT01938378|Secondary|Assessment of Hematocrit Levels|Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.|up to 8 days including the 24 hour follow-up|Not all patients received blood draws/multiple TPEs|||% of the blood that is red blood cells||Standard Deviation|Mean
2622606|NCT01938378|Secondary|Assessment of Hemoglobin Levels|Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.|up to 8 days including the 24 hour follow-up|Not all patients received blood draws/multiple TPEs|||g/dL||Standard Deviation|Mean
2622607|NCT01938378|Secondary|Assessment of Erythrocyte Levels|Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.|up to 8 days including the 24 hour follow-up|Not all patients received blood draws/multiple TPEs|||10^12 cells/L||Standard Deviation|Mean
2622608|NCT01938378|Secondary|Assessment of Leukocyte Levels|Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.|up to 8 days including the 24 hour follow-up|Not all patients received blood draws/multiple TPEs|||10^9 cells/L||Standard Deviation|Mean
2622609|NCT01938378|Secondary|Assessment of Sodium Levels|Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.|up to 8 days including the 24 hour follow-up|Not all patients received blood draws/multiple TPEs|||mmol/L||Standard Deviation|Mean
2622610|NCT01938378|Secondary|Assessment of Potassium Levels|Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.|up to 8 days including the 24 hour follow-up|Not all patients received blood draws/multiple TPEs|||mmol/L||Standard Deviation|Mean
2622611|NCT01938378|Secondary|Assessment of Glucose Levels|Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.|up to 8 days including the 24 hour follow-up|Not all patients received blood draws/multiple TPEs|||mg/dl||Standard Deviation|Mean
2622612|NCT01938378|Secondary|Assessment of Creatinine Levels|Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.|up to 8 days including the 24 hour follow-up|Not all patients received blood draws/multiple TPEs|||mg/dl||Standard Deviation|Mean
2622613|NCT01938378|Secondary|Assessment of Chloride Levels|Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.|up to 8 days including the 24 hour follow-up|Not all patients received blood draws/multiple TPEs|||mmol/L||Standard Deviation|Mean
2622614|NCT01938378|Secondary|Assessment of Carbon Dioxide Levels|Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.|up to 8 days including the 24 hour follow-up|Not all patients received blood draws/multiple TPEs|||mmol/L||Standard Deviation|Mean
2622615|NCT01938378|Secondary|Assessment of Blood Urea Nitrogen Levels|Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end.|up to 8 days including the 24 hour follow-up|Not all patients received blood draws/multiple TPEs|||mg/dL||Standard Deviation|Mean
2622616|NCT01938378|Primary|Monitoring of TEs and TEEs Caused by the Octaplas™Used for Plasma Exchange.|Monitoring of Thrombotic Events (TEs) and Thromboembolic Events (TEEs) caused by the octaplas™used for plasma exchange.|up to 8 days including the 24 hour follow-up from treatment||||event|||Number
2622617|NCT01938378|Primary|Monitoring of Adverse Drug Reactions Caused by the Octaplas™Used for Plasma Exchange.|Monitoring of adverse drug reactions caused by the octaplas™used for plasma exchange.|up to 8 days including the 24 hour follow-up from treatment||||event|||Number
2622618|NCT01938170|Secondary|Number of Subjects That Reported Ability to Successfully Administer FluMist Vaccine at Home|This study will also assess the feasibility of having parents/caregivers administer Flumist vaccine outside a traditional medical environment and without the direct participation of medical personnel. We will ask parents by telephone survey at both 24-48 hours and at 9-12 days after study visit and enrollment about any difficulties in giving FluMist at home, about maintaining temperature and conditions proper for vaccine storage until administration. We will also ask about ease of vaccine disposal and about child preferences for receiving vaccine at home compared to at a dedicated medical visit.|0-12 days||||participants|||Number
2622619|NCT01938170|Primary|Number of Subjects That Reported Successful Home Vaccination With no Adverse Events|We will assess the tolerability of giving the FluMist nasal vaccine at home by parents/caregivers to their children by performing telephone survey follow up. We will ask parents at both 24-48 hours and at 9-12 days after study visit and enrollment about any difficulties in giving FluMist at home and any adverse events encountered when giving FluMist at home.|0-12 days||||participants|||Number
2622620|NCT01938079|Primary|Cumulative Fentanyl Equivalents From ECMO Initiation to Decision to Achieve Wakefulness|Culmulative fentanyl equivalents meaning the combination of sedative drug regimen - measured in mg - from ECMO initiation to decision to achieve wakefulness.|Up to 14 days||||mg||Inter-Quartile Range|Median
2622621|NCT01938066|Secondary|Amount of Pain Medication Used (Morphine)|will measure the amount of pain medication used (morphine)|5 days||||mg||Standard Deviation|Mean
2622622|NCT01938066|Primary|Wound Infection|At the end of 5 days all subjects will get a Culture and Sensitivity to see if they have an infection or what type of infection they have in the wound|At the end of 5 days||||participants|||Number
2622623|NCT01938040|Secondary|Geriatric Depression Scale|15 questions. Score 1 point for each answer selected which indicates depression. Score of 0-5 is normal. A score >5 suggests depression.|Preoperatively, post operative day 1 and post op day3||||units on a scale||Standard Deviation|Mean
2622624|NCT01938040|Secondary|Cognitive Recovery.|Digits span forward subject is asked to repeat a series of numbers with increasing number of digits forward. Digit span backward subject is asked to repeat a series of numbers backward with increasing number of digits. Correct response is worth 1 point. Maximum of 14 points for each sub score with a total of 28 points for total score|preoperatively- 2 hours in PACU, Post op day #1, post op day#3||||units on a scale||Standard Deviation|Mean
2622625|NCT01938040|Other Pre-specified|Cytokine Concentrations|IFN y, IL-1B IL-2 were below the limit of detection and no assessments could be made. The lower limit for all cytokine detection was 3.2pg/mL|preoperative-intraoperative-postopoperative|||||||
2622626|NCT01938040|Secondary|Immune Response:Serum Concentration of IL-10,|.drawn in PACU 2 hours following arrival and compared to preoperative and intraoperative values|2 hours post arrival in PACU||||pg/mL||Full Range|Mean
2622627|NCT01938040|Secondary|Modified Fatigue Severity Scale|This questionnaire contains 9 statements that rate severity of fatigue symptoms. Score 1 indicates strong disagreement with the statement and 7= strong agreement. i.e (I am easily fatigued).Total lowest possible score indicating no fatigue is 9. Total highest possible score is 63 which correlates to severe fatigue, interfering with all activities of daily living.|preoperative-postoperative day 1 and day 3||||scores on a scale||Standard Deviation|Mean
2622628|NCT01938040|Secondary|Quality of Recovery-40|Quality of Recovery-40 has been used to assess postoperative recovery from anesthesia where higher score correlate with improved recovery and well being. The survey has 5 domains: comfort scale ranges 1-60 with higher value indicating greater comfort, emotions scale ranges 1-45 with higher value indicating best emotional state, physical independence scale ranges 1-25 with higher value indicating best independence, patient support scale ranges 1-35 with a higher score indicating greater support and pain scale 1-35 with higher number indicating greater relief from pain. Scoring is done for PART A on a scale of 1-5 (1=very poor=none of the time, worst score, 5=excellent=all of the time, best possible score).PART B on a scale of 1-5 (1=very poor or all the time worse score), 5=excellent or none of the time, best score) Perfect score=200.|preoperatively and -postoperative days 1 and 3||||units on a scale||Standard Deviation|Mean
2622629|NCT01938040|Secondary|Immune Response IL-6||2 hours postoperatively in PACU||||pg/mL||Full Range|Mean
2622630|NCT01938040|Post-Hoc|IL-6||preoperatively-intraoperatively-postoperatively||||pg/mL||Full Range|Mean
2622631|NCT01938040|Post-Hoc|Immune Response: TNF Alpha||preoperatively-intraoperatively-postoperatively||||pg/mL||Full Range|Mean
2622632|NCT01938040|Post-Hoc|Sympathetic Response: Epinephrine and Norepinephrine Plasma Concentrations||intraoperatively||||pg/mL||Standard Deviation|Mean
2622633|NCT01938040|Primary|Stress Response Inflammation Markers :Cortisol and C Reactive Protein (CRP)|Serum concentration of cortisol, CRP, drawn in Post Anesthesia Care unit at 2 hours following surgery were compared with those same levels drawn preoperatively and intraoperatively.|2 hours following end of surgery||||pg/mL||Standard Deviation|Mean
2622634|NCT01938001|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|"TEAEs include AEs that started or worsened between the date of the first dose and 28 days after the date of the last dose. A serious adverse event (SAE) is any:~Death;~Life-threatening event;~Any inpatient hospitalization or prolongation of existing hospitalization;~Persistent or significant disability or incapacity;~Congenital anomaly or birth defect;~Any other important medical event The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.03) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death"|From the first dose of study drug up to 28 days after the last dose of IP and those SAEs made known at any time; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm|The safety population was defined as all participants who have received at least one dose of study medication.|||Participants|||Count of Participants
2622635|NCT01938001|Secondary|Kaplan Meier Estimate of Time to Next Anti-Lymphoma Treatment (TTNLT)|Time to next anti-lymphoma treatment (TTNLT) was defined as the time from date of randomization to date of first documented administration of a new anti-lymphoma treatment (including chemotherapy, radiotherapy, radioimmunotherapy or immunotherapy). The time to the next anti-lymphoma treatment was of special interest to the study.|From randomization to data cut off of 22 Jun 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).|The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.|||months||95% Confidence Interval|Median
2622848|NCT01935180|Secondary|Ease of Terminal Ileum Intubation|"• Proportion of patients, for whom intubation of the terminal ileum with the colonoscope was rated as easy. Intubation could be rated by the endoscopist as easy, slightly difficult, difficult, or unable to intubate."|during colonoscopy||||Participants|||Count of Participants
2622636|NCT01938001|Secondary|Kaplan Meier Estimate of Event Free Survival as Assessed by the IRC According to the 2007 IWGRC|Event-free survival (EFS) was defined as the time from date of randomization to date of first documented progression, relapse, institution of new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy) or death from any cause. Responding participants and those who were lost to follow up were censored at their last tumor assessment date.|From date of randomization to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).|The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.|||months||95% Confidence Interval|Median
2622637|NCT01938001|Secondary|Kaplan-Meier Estimate of Duration of Complete Response (DOCR) as Assessed by the IRC According to the 2007 IWGRC|DOCR was defined as the time from initial CR until documented PD or death. Participants who had not progressed at the time of analysis were censored at the last assessment date that the participant was known to be progression free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participants was known to be progression free.|From randomization up to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).|Participants who achieved a complete response in the ITT population.|||months||95% Confidence Interval|Median
2622638|NCT01938001|Secondary|Kaplan-Meier Estimate of Duration of Objective Response as Assessed by the IRC According to the 2007 IWGRC|Duration of response (DOR) was defined as the time from initial response (at least PR) until documented progressive disease (PD) or death. Participants who had not progressed at the time of analysis were censored at the last assessment date that the participant was known to be progression free. Participants who received a new treatment without documented progression were censored at the last assessment date that the participants was known to be progression free.|From randomization up to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).|Participants who achieved an objective response in the ITT population.|||months||95% Confidence Interval|Median
2622639|NCT01938001|Secondary|Percentage of Participants With a Best Response of Complete Response as Assessed by the IRC According to the 2007 IWGRC|Percentage of participants with a best response of at CR during the study without administration of new anti-lymphoma therapy. A CR = Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities.|From date of first dose up to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm|The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.|||Percentage of Participants||95% Confidence Interval|Number
2622640|NCT01938001|Secondary|Percentage of Participants With an Objective Response as Assessed by the IRC According to the 2007 IWGRC|Percentage of participants with an objective response is defined as having a response of at least a PR during the study without administration of new anti-lymphoma therapy. A complete response = a complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities; a partial response (PR) = 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD.|From date of first dose to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomide arm and 11.04 months in the rituximab/placebo arm|The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.|||Percentage of Participants||95% Confidence Interval|Number
2622641|NCT01938001|Secondary|Kaplan-Meier Estimate of Overall Survival (OS)|Overall survival was defined as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|From the date of randomization to the cut-off date of 22 June 2018; The overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months)|The ITT population is defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.|||Months||95% Confidence Interval|Median
2622642|NCT01938001|Secondary|Durable Complete Response Rate (DCCR) as Assessed by the IRC According to the 2007 IWGRC|DCCR was defined as the percentage of participants with a best response of complete response (CR) that lasted no less than one year (≥ 48 weeks) during the study prior to administration of new anti-lymphoma therapy. A CR is defined as a complete disappearance of any disease-related symptoms and normalization of biochemical abnormalities.|From first dose of investigational product (IP) to data cut-off date of 22 June 2018; the median treatment duration was 11.19 months in the rituximab/lenalidomiade arm and 11.04 months in the rituximab/placebo arm|The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.|||Percentage of Participants||95% Confidence Interval|Number
2622643|NCT01938001|Primary|Kaplan Meier Estimate of Progression Free Survival Assessed by the Independent Review Committee (IRC) According to the 2007 International Working Group Response Criteria (IWGRC)|Progression-free survival (PFS) was defined as the time from date of randomization into the study to the first observation of documented disease progression or death due to any cause, whichever occurred first. PFS was based on the data from the IRC review using the modified 2007 International Working Group Response Criteria (IWGRC) using FDA censoring rules.|From randomization of study drug up to disease progression or death, which occurred first; up to the data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).|The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.|||months||95% Confidence Interval|Median
2622656|NCT01937975|Primary|Plasma Concentration at 24 Hours Postdose (C24hr) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||nM||95% Confidence Interval|Geometric Mean
2622644|NCT01937975|Primary|Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.|||Liters||95% Confidence Interval|Geometric Mean
2622645|NCT01937975|Primary|Apparent Clearance After Extravascular Administration (CL/F) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||Liters/hr||95% Confidence Interval|Geometric Mean
2622646|NCT01937975|Primary|Apparent Terminal Half-life (T1/2) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2622647|NCT01937975|Primary|Time of Maximum Plasma Concentration (Tmax) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||Hours||Full Range|Median
2622648|NCT01937975|Primary|Maximum Plasma Concentration (Cmax) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||uM||95% Confidence Interval|Geometric Mean
2622649|NCT01937975|Primary|Plasma Concentration at 24 Hours Postdose (C24hr) of Elbasvir|Blood for determination of Elbasvir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||nM||95% Confidence Interval|Geometric Mean
2622650|NCT01937975|Primary|Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Elbasvir|Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||uM*hr||95% Confidence Interval|Geometric Mean
2622651|NCT01937975|Primary|Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.|||Liters||95% Confidence Interval|Geometric Mean
2622652|NCT01937975|Primary|Apparent Clearance After Extravascular Administration (CL/F) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||Liters/hr||95% Confidence Interval|Geometric Mean
2622653|NCT01937975|Primary|Apparent Terminal Half-life (T1/2) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2622654|NCT01937975|Primary|Time of Maximum Plasma Concentration (Tmax) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||Hours||Full Range|Median
2622655|NCT01937975|Primary|Maximum Plasma Concentration (Cmax) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9|Up to 120 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||uM||95% Confidence Interval|Geometric Mean
2622657|NCT01937975|Primary|Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Grazoprevir|Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants)|Up to 24 hours postdose|The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model.|||uM*hr||95% Confidence Interval|Geometric Mean
2622658|NCT01937871|Secondary|Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at Week 2|The modified IPSS is the total IPSS collected at 2 weeks post-baseline.The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from ANCOVA. The model includes terms for treatment, country/region, prior alpha-blocker use and baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10.|Baseline, Week 2|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline mIPSS measurement.|||units on a scale||Standard Error|Least Squares Mean
2622659|NCT01937871|Secondary|Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 4 and Week 8|"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q3, Did your erection last long enough for you to have successful intercourse?. The SEP Q3 score is determined as the percentage of yes responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10."|Baseline, Week 4; Baseline, Week 8|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||"percentage of yes responses"||Standard Error|Least Squares Mean
2622660|NCT01937871|Secondary|Change From Baseline in Yes Responses to Question 2 of the SEP Questionnaire at Week 4 and Week 8|"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q2, Were you able to insert your penis into your partner's vagina?. The SEP Q2 score is determined as the percentage of yes responses to SEP Q2 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus the percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10."|Baseline, Week 4; Baseline, Week 8|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||"percentage of yes responses"||Standard Error|Least Squares Mean
2622661|NCT01937871|Secondary|Change From Baseline in IIEF EF at Week 4 and Week 8|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 were scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 was scored 1 (very low confidence) to 5 (very high confidence) with a total score ranging from 1 to 30. Higher scores represent better erectile function. LS mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 4; Baseline, Week 8|All randomized participants who had at least one dose of the study, had a baseline and at least one post-baseline IIEF measurement.|||units on a scale||Standard Error|Least Squares Mean
2622662|NCT01937871|Secondary|Change From Baseline in Total IPSS at Week 4 and Week 8|IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 4; Baseline, Week 8|All randomized participants who had at least one dose of the study, had a baseline and at least one post-baseline IPSS measurement.|||units on a scale||Standard Error|Least Squares Mean
2622685|NCT01937715|Secondary|Number of Participants With Gene and/or Protein Expression Biomarkers Relating to the PI3K and/or mTOR Pathway Activation in Biopsied Tumor Tissue|Biomarker evaluation were to be performed on fresh biopsies, as well as on archival biopsies collected during the study. Samples were to be analyzed for biomarkers indicative of pathway modulation or for genetic markers correlated to drug sensitivity.|Baseline and Cycle 2 Day 17|Paired fresh tumor biopsies were only done in 1 subject but not summarized.||||||
2622663|NCT01937871|Secondary|Change From Baseline in IIEF Subscores at Week 12|IIEF Question 3 asks how often a participant was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). IIEF Question 4 asks whether/how often a participant was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.|||units on a scale||Standard Error|Least Squares Mean
2622664|NCT01937871|Secondary|Change From Baseline in IIEF Sexual Desire at Week 12|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF sexual desire is the sum of Q11 and Q12. Scores ranged from 1 (low/almost never) to 5 (very high/almost always) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher scores were indicative of increased sexual desire. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.|||units on a scale||Standard Error|Least Squares Mean
2622665|NCT01937871|Secondary|Change From Baseline in IIEF Orgasmic Function at Week 12|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF orgasmic function is the sum of Q9 and Q10 of the IIEF. Scores ranged from 0 (no stimulation) to 5 (almost always) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher scores were indicative of better orgasmic function. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.|||units on a scale||Standard Error|Least Squares Mean
2622666|NCT01937871|Secondary|Change From Baseline in IIEF Intercourse Satisfaction at Week 12|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF-IS is the sum of Questions 6,7 and 8 of the IIEF. Scores range from 0(low/no satisfaction) to 5(high satisfaction) for each question, with the total possible score for the 3 questions ranging from 0 to 15.Higher scores were indicative of an increase in intercourse satisfaction. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction,centered baseline value(defined as the baseline value for a participant- the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.|||units on a scale||Standard Error|Least Squares Mean
2622667|NCT01937871|Secondary|Change From Baseline in IIEF Overall Satisfaction (OS) at Week 12|IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with a total subscore ranging from 2 to 10;higher scores represent better erectile function. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction,centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.|||units on a scale||Standard Error|Least Squares Mean
2622668|NCT01937871|Secondary|Number of Participants With Clinician Global Impression of Improvement (CGI-I) at Week 12|CGI-I measures clinician's perception of participant improvement at the time of assessment (compared with the start of treatment) with scores ranging from 1 (very much better) to 7 (very much worse).|Week 12|All randomized participants who received at least one dose of the study drug and had a baseline and at least one post-baseline CGI-I measurement.|||Participants|||Count of Participants
2622669|NCT01937871|Secondary|Number of Participants With Patient Global Impression of Improvement (PGI-I) at Week 12|PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse).|Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline PGI-I measurement.|||Participants|||Count of Participants
2622718|NCT01937520|Secondary|Tumor Necrosis Factor (TNF)|First two blood samples were collected during general anesthesia, first prior to surgical incision and Electro-acupuncture (EA), 2nd 60 minutes after incision and EA, third after arrival in PACU but before administration of analgesia. TNF is a critical pyrogen produced during acute phase of a reaction to trauma.|preoperatively-intraoperatively-postoperatively|female subjects|||pg/ml||Standard Error|Mean
2622670|NCT01937871|Secondary|Change From Baseline in IPSS Quality of Life (QoL) Index at Week 12|"IPSS QoL assess participant response to the following question:If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. Response options are Delighted(0),Pleased(1);Mostly satisfied(2);mixed about equally satisfied and dissatisfied(3);Mostly dissatisfied(4);Unhappy(5);Terrible(6),with a total ranging from 0 to 6; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares(LS) mean of change from baseline(bl) to endpoint is from MMRM.The model includes effects for treatment,country/region, prior alpha-blocker therapy,baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered bl value (defined as the bl value for a participant -the overall bl mean value),placebo lead-in total IPSS change(change from Visit 2 at Visit 3),centered bl-by-treatment and treatment-by-country/region interactions."|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline QoL measurement.|||units on a scale||Standard Error|Least Squares Mean
2622671|NCT01937871|Secondary|Change From Baseline in IPSS Voiding (Obstructive) Subscore at Week 12|IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score ranging from 0 to 20; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement.|||units on a scale||Standard Error|Least Squares Mean
2622672|NCT01937871|Secondary|Change From Baseline in IPSS Storage (Irritative) Subscore at Week 12|IPSS Storage (Irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore ranging from 0 to 15; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement.|||units on a scale||Standard Error|Least Squares Mean
2622673|NCT01937871|Secondary|Change From Baseline in Postvoid Residual Volume (PVR) at Week 12|The amount of urine remaining in the bladder after void completion.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline PVR measurement.|||milliliters (mL)||Standard Deviation|Mean
2622674|NCT01937871|Secondary|Change From Baseline in Uroflowmetry Measures at Week 12|"Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter).~At each visit, a uroflowmetry assessment was considered valid and the data were included only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >=125 mL. Changes in Qmax from baseline to endpoint in the double-blind treatment period were analyzed using Type III sums of squares ANOVA on rank-transformed data with a term for treatment group."|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline Uroflowmetry measurement.|||Milliliters/seconds (mL/sec)||Standard Deviation|Mean
2622675|NCT01937871|Secondary|Change From Baseline in IPSS at Week 12|IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM).The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline Erectile dysfunction (ED) severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement.|||units on a scale||Standard Error|Least Squares Mean
2622676|NCT01937871|Secondary|Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 12|"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q3, Did your erection last long enough for you to have successful intercourse?.The SEP Q3 score is determined as the percentage of yes responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10."|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||"percentage of yes responses"||Standard Error|Least Squares Mean
2622849|NCT01935180|Secondary|Withdrawal Time|• Time taken for the withdrawal of the colonoscope from the cecum to anus among patients, who did not have any polyps.|time of colonoscope withdrawal||||minutes||Inter-Quartile Range|Median
2622677|NCT01937871|Secondary|Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12|"Participant-assessed diary assesses the mean change from baseline in the percentage of yes responses to SEP Q2, Were you able to insert your penis into your partner's vagina?. The SEP Q2 score was determined as the percentage of yes responses to SEP Q2 out of all sexual attempts recorded during the time period. Change is defined as the percentage of yes responses at endpoint minus the percentage of yes responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10."|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.|||"percentage of yes responses"||Standard Error|Least Squares Mean
2622678|NCT01937871|Secondary|Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12|IIEF is a 15 item self-reported questionnaire to assess overall erectile function and satisfaction during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0(low/no erectile function) to 5(high erectile function) and Question 15 is scored 1(very low confidence) to 5(very high confidence) with a total score ranging from 1 to 30.Higher scores represent better erectile function.LS mean of change from baseline to endpoint is from MMRM.The model includes effects for treatment,country/region,baseline lower urinary tract symptoms(LUTS) severity (moderate/severe),visit,treatment-by-visit interaction,centered baseline value(defined as the baseline value for a participant-the overall baseline mean value), placebo lead-in total IPSS change(change from Visit 2 at Visit 3),centered baseline-by-treatment and treatment-by-country/region interactions.The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who had at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement.|||units on a scale||Standard Error|Least Squares Mean
2622679|NCT01937871|Primary|Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12|IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM).The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline Erectile dysfunction (ED) severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment.The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.|Baseline, Week 12|All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement.|||units on a scale||Standard Error|Least Squares Mean
2622680|NCT01937715|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Colorectal (FACT-C) (Phase 2)|The FACT-C was to assess health-related quality of life and colorectal cancer (CRC)-related symptoms. It includes a total of 36 items, which are summarized into 6 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), CRC subscale (9 items) which addresses a subset of CRC concerns such as diarrhea.|Day 1 of each cycle|FACT-C was only applicable to the Phase 2 portion of the study. As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, no data were collected for Phase 2.||||||
2622681|NCT01937715|Secondary|Number of Participants With Evidence of Pathway Signaling Related Genes and/or Proteins in Biopsied Tumor Tissue (Phase 2)|Biomarker evaluation were to be performed on these fresh biopsies, as well as on archival biopsies collected during the study. Samples were to be analyzed for biomarkers indicative of pathway modulation or for genetic markers correlated to drug sensitivity.|Baseline and Cycle 2 Day 17|Levels of signaling proteins in biopsied tumor tissue was the secondary endpoint for the Phase 2 portion of the study. As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, no data were collected for Phase 2.||||||
2622682|NCT01937715|Secondary|Overall Survival (Phase 2)|Overall survival is the time from randomization date to date of death due to any cause.|Day 1 up to Day 28|As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, there are no efficacy evaluations for Phase 2. No data were collected for Phase 2.||||||
2622683|NCT01937715|Secondary|Duration of Response (Phase 2)|Duration of response is the time from first documentation of CR or PR to date of first documentation of objective progression or death.|Day 1 to Day 28|As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, there are no efficacy evaluations for Phase 2. No data were collected for Phase 2.||||||
2622684|NCT01937715|Secondary|Number of Participants With Best Overall Response (Phase 2)|Best overall response is defined as the best response recorded from randomization (or first dose for patients in the Phase 1B) until disease progression, death, start of new anti-cancer treatment or end of study. The categories for best overall response include: complete response (CR) (complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis <10 millimeters (mm)); partial response (PR) (at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters); stable disease (SD) (not qualify for CR, PR or Progression); progressive disease (PD) (20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm); indeterminate (IND) (progression has not been documented).|Day 1 up to Day 28|As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, there are no efficacy evaluations for Phase 2. No data were collected for Phase 2.||||||
2622850|NCT01935180|Secondary|Quality of Bowel Preparation|Proportion of patients with a bowel preparation that was rated as good or excellent (four point scale that distinguishes the bowel prep as poor, fair, good or excellent).|duration of colonoscopy||||Participants|||Count of Participants
2622686|NCT01937715|Secondary|Number of Participants With Expression of Gene Sequences or Gene Amplications in Biopsied Tumor Tissue|Biomarker evaluation were to be performed on fresh biopsies, as well as on archival biopsies collected during the study. Samples were to be analyzed for biomarkers indicative of pathway modulation or for genetic markers correlated to drug sensitivity.|Baseline and Cycle 2 Day 17|Paired fresh tumor biopsies were only done in 1 subject but not summarized.||||||
2622687|NCT01937715|Secondary|Number of Participants Meeting Maximum Post-Baseline QTc Interval Values|Criteria for corrected QT interval using Fridericia's formula (QTcF) meeting potential clinical concern included: an absolute value >=450 - <480 msec, >=480-<500 msec, >500 msec; an absolute change 30 - <60, >=60 msec.|Baseline, Cycle 1 Day 1, and Cycle 2 Day 2|All participants who received at least 1 dose of study medication.|||participants|||Number
2622688|NCT01937715|Secondary|Terminal Elimination Half-Life (t1/2): PF-05212384 and Irinotecan|Terminal Elimination Half-Life of PF-05212384 and Irinotecan|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.|||hour||Standard Deviation|Mean
2622689|NCT01937715|Secondary|Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf): PF-05212384 and Irinotecan|Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time of PF-05212384 and Irinotecan|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2622690|NCT01937715|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast): PF-05212384 and Irinotecan|Area Under the Curve From Time Zero to Last Quantifiable Concentration of PF-05212384, and Irinotecan|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2622691|NCT01937715|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): PF-05212384, Irinotecan, and Fluorouracil|Time to Reach Maximum Observed Plasma Concentration of PF-05212384, Irinotecan, and Fluorouracil|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1. Fluorouracil: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.|||hour (hr)||Full Range|Median
2622692|NCT01937715|Secondary|Maximum Observed Plasma Concentration (Cmax): PF-05212384, Irinotecan, and Fluorouracil|Maximum Plasma Concentration of PF-05212384, Irinotecan, and Fluorouracil|PF-05212384: Cycle 1 Day 3. Irinotecan: Cycle 1 Day 1. Fluorouracil: Cycle 1 Day 1.|Randomized participants (or enrolled participants for Phase 1B) who started treatment and who had at least one of the pharmacokinetic parameters of interest estimated.|||nanogram (ng)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
2622693|NCT01937715|Secondary|Number of Participants With Urinalysis Test Abnormalities|Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Urinalysis test abnormalities.|Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2 and subsequent cycles|All participants who received at least 1 dose of study medication.|||participants|||Number
2622694|NCT01937715|Secondary|Number of Participants With Chemistry Test Abnormalities|Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Chemistry test abnormalities.|Day 1 and Day 15 of each cycle|All participants who received at least 1 dose of study medication. n=number of participants evaluated against criteria.|||participants|||Number
2622695|NCT01937715|Secondary|Number of Participants With Coagulation Test Abnormalities|Number of participants with NCI CTCAE version 4.0 grade 1 to 4 Coagulation test abnormalities.|Day 1 and Day 15 of Cycle 1, Day 1 of Cycle 2 and subsequent cycles|All participants who received at least 1 dose of study medication. n=number of participants evaluated against criteria.|||participants|||Number
2622696|NCT01937715|Secondary|Number of Participants With Hematological Test Abnormalities|Number of participants with NCI CTCAE version 4.0 grade 1 to 4 hematological test abnormalities.|Day 1 and Day 15 of each cycle|All participants who received at least 1 dose of study medication.|||participants|||Number
2622697|NCT01937715|Secondary|Number of Participants With Treatment-Emergent AEs by Worst On-Study Grade|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. AE grades were defined according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria.|Baseline up to final study evaluation (within 28 days of last dose)|All participants who received at least 1 dose of study medication.|||participants|||Number
2622698|NCT01937715|Secondary|Number of Participants With All Causality AEs by System Organ Class (SOC)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug.|Baseline up to final study evaluation (within 28 days of last dose)|All participants who received at least 1 dose of study medication.|||participants|||Number
2622699|NCT01937715|Secondary|Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations by Relationship and Seriousness|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if the event occurred for the first time after the start of study treatment and within 28 days after final dose of study treatment and was not seen prior to the start of treatment; or the event was seen prior to the start of treatment but increased in CTCAE version 4.0 grade after the start of study treatment and within 28 days after final dose of study treatment.|Baseline up to final study evaluation (within 28 days of last dose)|All participants who received at least 1 dose of study medication.|||participants|||Number
2622719|NCT01937520|Secondary|Glucose|the first two blood samples were collected during general anesthesia, the first prior to surgical incision and electroacupuncture, the second 60 minutes after incision time and at the completion of electroacupuncture, the third after arrival in PACU but before the administration of analgesia.|serum glucose from baseline to PACU arrival|females|||mg/dL||Standard Error|Mean
2622720|NCT01937520|Primary|Pain Levels|Visual Acuity scale 0=no pain 10= worst pain possible|PACU, day 1 , day 2, day 3|female patients self reported pain experience following surgery|||units on a scale||Standard Error|Mean
2622700|NCT01937715|Secondary|Number of Participants With Best Overall Response (Phase 1B)|Best overall response is defined as the best response recorded from randomization (or first dose for patients in the Phase 1B) until disease progression, death, start of new anti-cancer treatment or end of study. The categories for best overall response include: complete response (CR) (complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis <10 millimeters (mm)); partial response (PR) (at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters); stable disease (SD) (not qualify for CR, PR or Progression); progressive disease (PD) (20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm); indeterminate (IND) (progression has not been documented).|Every 8 weeks from Cycle 1 Day 1 until 28 days of last dose|All participants in the full analysis (FA) set who had measureable disease and an adequate baseline assessment of the disease.|||participants|||Number
2622701|NCT01937715|Primary|Progression-Free Survival (PFS)|Progression-free survival was the time from randomization the date to date of first documentation of progression or death due to any cause, whichever occurred first. Documentation of progression was by objective disease assessment as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.|Baseline (Day 1) up to disease progression or death whichever occurred first (up to 18 months)|PFS was the primary efficacy endpoint for the study and was only to be assessed in the Phase 2 portion of the study. As this study was terminated due to Pfizer portfolio prioritization prior to the Phase 2 portion, there are no efficacy evaluations for Phase 2.||||||
2622702|NCT01937715|Primary|Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle of Therapy|DLTs were classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and defined as any of the following events judged to be attributed to the combination of PF-05212384 plus FOLFIRI: hematologic (febrile neutropenia or a sustained temperature >=38 degrees Celcius for >1 hour, grade >=3 neutropenic infection, grade 3 thrombocytopenia with bleeding, grade 4 thrombocytopenia); non-hematologic (grade >=2 pneumonitis, grade >=3 toxicities, toxicities which resulted in failure to deliver at least 75% of the planned total dose of PF-05212384 and/or 50% of the planned total dose of FOLFIRI during the first cycle, toxicities which resulted in delay of start of Cycle 2 by >2 weeks of scheduled day (Day 43 of study), Grade 3 QTc prolongation).|Day 1 up to Day 28|The dose limiting toxicity analysis set included participants in Phase 1B who started treatment and who did not have a major treatment deviation in the lead-in period and the first cycle of treatment.|||percentage of participants|||Number
2622703|NCT01937624|Primary|Presence of Fracture|Diagnostic ultrasound will be used to determine if the bones do or do not have a fracture. Fractures will be based on the presence or absence of cortical disruption or irregularity on the ultrasound.|Duration of office visit|Each of the 51 participants received both an ultrasound and a x-ray.|||Participants|||Count of Participants
2622704|NCT01937598|Secondary|AUC Active GIP||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)||||pmol/l*min||Standard Error|Mean
2622705|NCT01937598|Secondary|AUC Active GLP-1||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)||||pmol/l*min||Standard Error|Mean
2622706|NCT01937598|Secondary|AUC Total GIP||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)||||pmol/l*min||Standard Error|Mean
2622707|NCT01937598|Secondary|AUC Total GLP-1||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)||||pmol/l*min||Standard Error|Mean
2622708|NCT01937598|Secondary|AUC Glucagon||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)||||pmol/l*min||Standard Error|Mean
2622709|NCT01937598|Secondary|AUC C-peptide||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)||||nmol/l*min||Standard Error|Mean
2622710|NCT01937598|Secondary|AUC Insulin||Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)||||nmol/l*min||Standard Error|Mean
2622711|NCT01937598|Secondary|AUC Plasma Glucose|Incremental AUC from 0 to 300 min|Approximately 6 weeks (range 9 - 60 days / 8.5 weeks)||||mmol/l*min||Standard Error|Mean
2622712|NCT01937598|Primary|Incremental Area Under the Plasma Glucose (BG) Concentration-time Profile (AUC)|Incremental area under the plasma glucose (BG) concentration-time profile (AUC) immediately before to 300 min after a mixed meal test. In addition, the time course of BG values will be analysed with an ANCOVA model for repeated measurements with placebo baseline values as covariate. Time points to create the curce were 0, 15, 30, 45, 60, 90, 120, 150, 180, 240 and 300 minutes post mixed meal test.|0 to 300 min post mixed meal test||||[mg*min/dL]||Standard Error|Mean
2622713|NCT01937520|Secondary|Serum Insulin Level|to determine if electroacupuncture reduced hyperglycemia|preoperative and postoperative|female subjects preoperatively and postoperatively|||pg/ml||Standard Error|Mean
2622714|NCT01937520|Secondary|TGFB1|TGFB1 is a pleiotropic factor regulating the immune system and healing. First two blood samples drawn under general anesthesia, first prior to surgical incision and EA, the 2nd 60 minutes after incision and EA, third after arrival in PACU but before administration of analgesia.|Preoperatively-intraoperatively-postoperatively|all females; then females by groups age (<45 years and >45 years) and weight (<75kg and >75kg)|||pg/ml||Standard Error|Mean
2622715|NCT01937520|Secondary|IL-10|IL-10 is an anti-inflammatory cytokine marker. First two blood samples were collected during general anesthesia, first prior to surgical incision and EA, 2nd 60 minutes following incision and EA, and the third after arrival in PACU but before administration of analgesia.|Preoperatively-intraoperatively-postoperatively|total females; then those grouped by age (<45years and>45 years) and weight (<75 Kg and >75kg)|||pg/ml||Standard Error|Mean
2622716|NCT01937520|Secondary|IL-6|First two blood samples were collected during general anesthesia, first prior to Surgical incision and EA, 2nd 60 minutes after incision and EA and the 3rd after arrival in PACU but before administration of analgesia. IL-6 is a critical inflammatory cytokine produced during the acute phase of reaction to trauma|Preoperatively-intraoperatively-postoperatively|total female results; then females divided into age groups (<45 or >45years) and weights groups (<75kg and >75kg)|||pg/ml||Standard Error|Mean
2622717|NCT01937520|Secondary|iNTERLEUKIN (IL-2 and IL-4)|both are IL-2 and IL-4 are critical cytokines regulating the cellular response to induce cellular versus hormone immunity. First two blood samples were collected during general anesthesia: first prior to surgical incision and electroacupuncture, second 60 minutes after incision and electroacupuncture and the 3rd after arrival in PACU but before analgesia.|Preoperatively-intraoperatively-postoperatively|all females|||pg/ml||Standard Error|Mean
2622721|NCT01937520|Primary|Morphine Equivalent|equivalent doses of morphine for analgesic relief. All analgesic treatments were converted to morphine equivalents in milligrams.|PACU, day 1 , day 2, day 3|since gender impacts the threshold for analgesic and pain the effects of electroacupuncture on females was analyzed. The same number of females were in both groups but since one subject had preexisting levels of TNF>1ug/ml prior to surgery she was eliminated from the dta base|||mg morphine||Standard Error|Mean
2622722|NCT01937520|Secondary|Cortisol|All blood samples were collected during general anesthesia, the first prior to surgical incision and electroacupuncture, the second 60 minutes after incision time and at the completion of electroacupuncture, the third after arrival in PACU but before the administration of analgesia.|prior to surgical incision, 1 hour following incision, after arrival in PACU|females|||ng/ml||Standard Error|Mean
2622723|NCT01937520|Secondary|Modified Quality of Recovery Scale|Modified patient self reported scale with 9 questions regarding general well being including ability to eat, free from constant pain, able to manage activities of daily living. 0= worst possible score and 18=best outcome score|Day 1, 2, 3|all females|||units on a scale||Standard Error|Mean
2622724|NCT01937520|Secondary|Morphine Equivalent (mg)|morphine equivalent to analyze whether body weight affected the efficacy of electroacupuncture|PACU arrival to 2 hours post op|females with body weight <75 kg and >than 75 kg|||mg morphine||Standard Error|Mean
2622725|NCT01937520|Secondary|Morphine Equivalent|All analgesic treatments were converted to morphine equivalents in milligrams .|PACU to 2 hours post op|females grouped by age (<45 years and 45 years or greater)|||mg of Morphine||Standard Error|Mean
2622726|NCT01937520|Secondary|(ACTH )Adrenocorticotropic Hormone|All blood samples were collected during general anesthesia, the first prior to surgical incision and electroacupuncture, the second 60 minutes after incision time and at the completion of electroacupuncture, the third after arrival in PACU but before the administration of analgesia. The data below represents female patients only|serum ACTH from baseline/preoperatively,intraoperatively, upon arrival in PACU|females|||pg/ml||Standard Error|Mean
2622727|NCT01937520|Primary|Visual Acuity Score (VAS)|VAS is a self reported pain scale with a score ranging from 0 to 10. 0= no pain, 10=worst pain possible. Multiple pain sacores were recorded. single value is reported by average|arrival in PACU to 2 hours post operatively|all study participants|||units on a scale||Standard Error|Mean
2622728|NCT01937520|Primary|Reduced Pain Medication Requirement|analgesia provided in Post Anesthesia Care Unit PACU)|amount of pain medication provided in PACU|All subjects enrolled in study|||mg of Morphine||Standard Error|Mean
2622729|NCT01937507|Secondary|To Document the Toxicity, Tolerability of the Therapy in This Population.|Document the toxicity and tolerability of the therapy using the following CBC with differential, BUN, creatinine, liver function tests,CA 15-3, CA 27.29, Circulating tumor cells (CTCs)and Restaging radiographic studies (MRI or CT liver protocol).|one year|Data was not collected||||||
2622730|NCT01937507|Primary|Extra-hepatic Progression (TEP) of HAI With Oxaliplatin/5-FU|To determine time to extra-hepatic progression (TEP) of HAI with oxaliplatin/5-FU every three weeks in heavily pre-treated patients with advanced breast cancer with metastasis to the liver.|One year|Data was not collected||||||
2622731|NCT01937507|Primary|Determine Time to Intra-hepatic Progression (TIP) of HAI With Oxaliplatin/5-FU Every Three Weeks in Heavily Pre-treated Patients With Advanced Breast Cancer With Metastasis to the Liver.|To determine time to intra-hepatic progression (TIP) of HAI with oxaliplatin/5-FU every three weeks in heavily pre-treated patients with advanced breast cancer with metastasis to the liver.|One year|Data was not collected||||||
2622732|NCT01937507|Primary|Determine Response Rate (RR) of HAI With Oxaliplatin/5-FU Every Three Weeks in Heavily Pre-treated Patients With Advanced Breast Cancer With Metastasis to the Liver.|To determine response rate (RR) of HAI with oxaliplatin/5-FU every three weeks in heavily pre-treated patients with advanced breast cancer with metastasis to the liver.|One year|Data was not collected||||||
2622733|NCT01937390|Secondary|Reasons of Non-adherence to Once-daily Long-acting Bronchodilators in COPD Patients|Percentage of subjects corresponding to each reason of non-adherence to once-daily long-acting bronchodilators in COPD patients are presented.|13 months|ITT|||Percentage of participants|||Number
2622734|NCT01937390|Primary|Number of COPD Exacerbations, Per Patient|"Percentage of subjects experienced COPD exacerbations exactly n number of times during the study period is presented. Here, n represents the number of times each subject experienced COPD exacerbations."|13 months|ITT|||Percentage of participants|||Number
2622735|NCT01937390|Primary|Number of COPD Exacerbations Leading to Hospitalization, Per Patient|"Percentage of subjects hospitalized due to COPD exacerbations exactly n number of times during the study period is presented. Here, n represents the number of times each subject is hospitalized due to COPD exacerbations."|13 months|ITT|||Percentage of participants|||Number
2622736|NCT01937390|Primary|CCQ Total Score at Month 13 (Visit 4)|Mean and standard deviation of CCQ total score is presented at month 13.|13 months|ITT (observed cases)|||Units on a scale||Standard Deviation|Mean
2622737|NCT01937390|Primary|Clinical COPD Questionnaire (CCQ) Total Score Change From Baseline at Month 13|"The Clinical COPD (Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) is a standardized, validated and reliable questionnaire (in local language) to assess the impact of treatment on health status in COPD patients. CCQ total score is calculated as the arithmetic average of 10 individual scores on a 7-point scale. CCQ total score varies from 0 (very good control) to 6 (extremely poor control). Mean change in CCQ total score from baseline at month 13 is presented along with its standard error. Change in CCQ total score is calculated for each subject as:~CCQ total score at month 13 - CCQ total score at baseline. Baseline is defined as the first assessment after enrolment (at Month 1)."|Baseline and 13 Month|Intent-to-treat (ITT): This population set included all subjects who signed informed consent form (ICF), satisfied all inclusion and exclusion criteria and have taken at least one dose of study drug.|||Units on a scale||Standard Error|Mean
2622738|NCT01937364|Secondary|Peak and Total Benzodiazepine Dose Required||72 hours||||Doses||Inter-Quartile Range|Median
2622739|NCT01937364|Secondary|Severity of Alcohol Withdrawal Symptoms as Measured on the CIWA-Ar Scale and Assessed at 24, 48, and 72 Hours After Enrollment|Range: 0 to 67; larger values indicate greater severity|72 hours|All CIWA-Ar scores collected at and after the baseline measurement.|||units on a scale||Standard Error|Mean
2622851|NCT01935180|Secondary|Advanced Adenoma Detection Rate|Proportion of patients with advanced adenomas|duration of colonoscopy||||Participants|||Count of Participants
2622740|NCT01937364|Primary|Moderate or Severe Alcohol Withdrawal Syndrome|Moderate or severe AWS was defined as a CIWA-AR score of at least 11.|72 hours|Subjects who either had AWS prior to the collection of the 72-hour CIWA-Ar score or had a CIWA-Ar score either recorded as the 72-hour CIWA-Ar score or occurring within the one-hour window for the 72-hour CIWA-Ar score are evaluable for this endpoint.|||Participants|||Count of Participants
2622741|NCT01937351|Secondary|Secondary Effectiveness Endpoint|Changes in Quality of Life measures from Baseline at 30 days and 6 months using Short Form (SF)-12 & Vascular Quality of Life (VascuQoL).|Day 0, Day 60 and 6 Months||2017-04-30|04/2017||||
2622742|NCT01937351|Secondary|Secondary Effectiveness Endpoint|Rutherford Classification at 30 days and 6 months.|Day 0, Day 30 and 6 Months|||||||
2622743|NCT01937351|Secondary|Secondary Effectiveness Endpoint|Ankle-Brachial Index at 30 days and 6 months.|Day 30 and 6 Months|||||||
2622744|NCT01937351|Secondary|Secondary Effectiveness Endpoint|Procedural success defined as the percent of target lesions that have residual diameter stenosis < 30% post-Pantheris and any other adjunctive therapy, determined by independent Angiographic Core Laboratory.|Day 0|||||||
2622745|NCT01937351|Secondary|Secondary Safety Endpoint|Freedom from clinically driven Target Vessel Revascularization (TVR) through 6 months, as adjudicated by an independent CEC.|Day 0 through 6 Months||2017-04-30|04/2017||||
2622746|NCT01937351|Secondary|Secondary Safety Endpoint|Freedom from procedural emboli, defined as a change in any visualized runoff vessel (other than vasospasm and dissection) at any time during the procedure.|Day 0|||||||
2622747|NCT01937351|Secondary|Secondary Safety Endpoint|Freedom from MAEs as defined above, through 30 days (or hospital discharge, whichever is longer) as adjudicated by an independent CEC.|Day 0 through Day 30||||percentage of subjects|||Number
2622748|NCT01937351|Primary|Primary Effectiveness Endpoint|The primary efficacy endpoint of technical success is defined as the percent of target lesions that have a residual diameter stenosis <50% post the Pantheris device alone, as assessed by an independent Angiographic Core Laboratory.|Day 0|Analysis was performed on per protocol cohort, and results were calculated based on number of lesions that were treated.|||percentage of lesions|lesions||Number
2622749|NCT01937351|Primary|Primary Safety Endpoint|"The primary safety endpoint is defined as freedom from a composite of major adverse events (MAE) through 6-Month follow-up as adjudicated by an independent Clinical Events Committee (CEC). Individual MAEs include:~Cardiovascular related death~Unplanned, major index limb amputation~Clinically driven target lesion revascularization (TLR)~Myocardial infarction~Device related events:~Clinically significant perforation~Clinically significant dissection~Clinically significant embolus~Pseudoaneurysm"|Day 0 through 6 Months|All per-protocol subjects who completed the 6-month follow-up were included in the analysis|||percentage of subjects|||Number
2622750|NCT01937312|Secondary|Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM)|IOP was assessed using Goldmann applanation tonometry and reported in mmHg. One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.|||mmHg||Standard Deviation|Mean
2622751|NCT01937312|Secondary|Mean Diurnal IOP Percentage Change From Baseline to Week 6|Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP.|Baseline, Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.|||percent change||Standard Deviation|Mean
2622752|NCT01937312|Secondary|Mean Diurnal IOP Change From Baseline to Week 6|Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.|Baseline, Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.|||mmHg||Standard Deviation|Mean
2622753|NCT01937312|Primary|Mean Diurnal Intraocular Pressure (IOP) at Week 6|Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy visit (intent-to-treat). Last observation carried forward (LOCF) was not utilized; therefore, results report subjects present at Week 6 with no imputation for missingness.|||mmHg||Standard Deviation|Mean
2622767|NCT01937130|Secondary|Levels of Caspase 3/7 RLU|Concentration of Caspase 3/7 Relative Light Units|Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28|"Number of subjects analyzed varied by time point; Day2: 5 and 25 arms are 4 and 6; Day4: 25 and placebo arms are 6 and 2; Day7: 25 arm is 6; Day14: 5, 25, 50, and placebo arms are 2, 5, 3, and 2; Day21: 5, 25, 50, and placebo arms are 2, 3, 2, and 2; Day28: 5, 25, 50, and placebo arms are 0, 3, 2, and 2; 0 are non-estimable values"|||RLU||Inter-Quartile Range|Median
2622852|NCT01935180|Secondary|Adenoma Detection Rate|• Adenoma detection rate (ADR), % of patients with at least 1 adenoma|duration of colonoscopy||||Participants|||Count of Participants
2622754|NCT01937299|Secondary|Mean Diurnal IOP Percentage Change From Baseline to Week 6|Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP Percentage Change was defined as the average of the four percent changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A more negative percent change from baseline indicates a greater amount of improvement, i.e., a reduction of IOP.|Baseline, Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy study visit. Last observation carried forward (LOCF) was not utilized; therefore results report subjects present at Week 6 with no imputation for missingness.|||percent change||Standard Deviation|Mean
2622755|NCT01937299|Secondary|Mean Diurnal IOP Change From Baseline to Week 6|Baseline IOP was defined as the average of the timepoint-matched IOP measurements at Eligibility 1 and Eligibility 2 Visits. Diurnal IOP change was defined as the average of the four changes from baseline (timepoints 8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP.|Baseline, Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy study visit. Last observation carried forward (LOCF) was not utilized; therefore results report subjects present at Week 6 with no imputation for missingness.|||mmHg||Standard Deviation|Mean
2622756|NCT01937299|Primary|Mean Diurnal Intraocular Pressure (IOP) at Week 6|Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the analyses. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 6|This analysis population includes all subjects who received study medication and completed at least 1 scheduled on-therapy study visit. Last observation carried forward (LOCF) was not utilized; therefore results report subjects present at Week 6 with no imputation for missingness.|||mmHg||Standard Deviation|Mean
2622757|NCT01937260|Primary|The Area Under the Drug-concentration Curve of Midazolam After a Single Dose of Brodalumab From Zero Tot he Last Time of Quantifiable Concentration|Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2|Day 1 to Day 9|20 subjects are now analyzed after the discontinuation of 1 subject by sponsor decision|||hr*ng/mL||Standard Deviation|Mean
2622758|NCT01937260|Primary|The Area Under Drug Concentration Time Curve From Zero to Infinity (AUCinf)|Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2 with PK sampling collected on day 30|Day 1 to Day 9|20 subjects analyzed after the discontinuation of 1 subject by sponsor decision|||hr*ng/mL||Standard Deviation|Mean
2622759|NCT01937260|Primary|The Maximum Observed Concentration of Midazolam After a Single Dose of Brodalumab|Midazolam pharmacokinetic parameter estimates after single oral dose of Midazolam 2 mg on Day 1 and Day 9 and a single administration of Brodalumab 210 mg on Day 2 with PK sampling collected on Day 30|Day 1 to day 9|Analysis population is now 20 subjects after 1 subject was discontinued by sponsor decision|||nanograms per milliliter||Standard Deviation|Mean
2622760|NCT01937195|Secondary|"Percentage of Patients Who Identified as Satisfied With Catheter Performance at Catheter Removal"|Patients were surveyed regarding satisfaction with catheter performance with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.|At catheter removal, which is expected to be up to 7 days post placement|Inpatients requiring IV therapy|||percentage of participants||95% Confidence Interval|Number
2622761|NCT01937195|Secondary|Number of Participants Experiencing Adverse Events|Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time up to 7 days. Adverse events are anticipated complications of IV therapy.|baseline, and up to catheter removal expected to be no more than 7 days post placement|Inpatients requiring IV therapy.|||participants|||Number
2622762|NCT01937195|Secondary|"Percentage of Patients Who Identified as Satisfied With Catheter Performance at Catheter Insertion"|Patients were surveyed regarding satisfaction with catheter insertion with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.|Baseline at catheter insertion in the first 3-15 minutes after procedure|Inpatients requiring IV therapy|||percentage of participants||95% Confidence Interval|Number
2622763|NCT01937195|Secondary|Catheter Dwell Time|Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) up to 7 days.|Study exit/at catheter removal expected to be up to 7 days post placement||||hours||95% Confidence Interval|Mean
2622764|NCT01937195|Secondary|Completion of IV Therapy|Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (generally up to 7 days).|Study exit/at catheter removal expected to be up to 7 days post placement|Inpatients requiring IV therapy.|||Participants|||Count of Participants
2622765|NCT01937195|Secondary|Percentage of Patients With Complications of Peripheral IV Therapy|Will measure the percentage of patients with (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (up to 7 days).|Study exit/at catheter removal expected to be up to 7 days post placement|Inpatient units requiring IV therapy.|||percentage of patients||95% Confidence Interval|Number
2622766|NCT01937195|Primary|Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt|The primary endpoint is to observe the rate of first attempt success (where the inserter only pierces the skin once and successfully places the PIV catheter in the vein) in patients requiring PIV access.|Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure|Inpatients requiring IV therapy.|||percentage of participants||95% Confidence Interval|Number
2622853|NCT01935180|Primary|Mean Number of Adenomas|Mean number of adenomas per patient in each group.|duration of colonoscopy||||adenoma per patient||Standard Deviation|Mean
2622768|NCT01937130|Secondary|Levels of CK18/M65|Caspase full-length cytokeratin serum levels CK18/M65|Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28|"Number of subjects analyzed varied by time point; Day2: 5 and 25 arms are 4 and 6; Day4: 25 and placebo arms are 6 and 2; Day7: 25 arm is 6; Day14: 5, 25, 50, and placebo arms are 2, 5, 3, and 2; Day21: 5, 25, 50, and placebo arms are 2, 3, 2, and 2; Day28: 5, 25, 50, and placebo arms are 0, 3, 2, and 2; 0 are non-estimable values"|||U/L||Inter-Quartile Range|Median
2622769|NCT01937130|Secondary|Levels of CK18/M30|Caspase-cleaved cytokeratin serum levels (CK18/M30)|Baseline, Day 2, Day 4, Day 7, Day 14, Day 21, and Day 28|"Number of subjects analyzed varied by time point; Day2: 5 and 25 arms are 4 and 6; Day4: 25 and placebo arms are 6 and 2; Day7: 25 arm is 6; Day14: 5, 25, 50, and placebo arms are 2, 5, 3, and 2; Day21: 5, 25, 50, and placebo arms are 2, 3, 2, and 2; Day28: 5, 25, 50, and placebo arms are 0, 3, 2, and 2; 0 are non-estimable values"|||U/L||Inter-Quartile Range|Median
2622770|NCT01937130|Primary|Tmax & t1/2 Parameters|Primary endpoints for tmax & t1/2 on Day 1 and Day 4 for the active treatment arms were analyzed.|28 Days|"t1/2 number of participants analyzed at Day 1 in the 5mg arm was 2 and 1 at Day 4, in the 25mg arm was 5 at Day 1 and 2 at Day 4, in the 50mg arm was 2 at Day 1 and 3 at Day 4.~Values listed as 0 were non-estimable values."|||(h)|Participants|Standard Deviation|Mean
2622771|NCT01937130|Primary|Cmax|Primary endpoints forCmax on Day 1 and Day 4 for the active treatment arms were analyzed.|28 Days||||(ng/mL)|Participants|Geometric Coefficient of Variation|Geometric Mean
2622772|NCT01937130|Primary|Area Under the Curve (AUC)|Primary endpoints for AUC_0-8, AUC_0 last, AUC_0-inf on Day 1 and Day 4 for the active treatment arms were analyzed.|28 days|"AUC_0-last: The number of participants analyzed in the 25mg arm was 7 at Day 1 AUC_0-inf: The number of participants analyzed in the 5mg arm was 2 at Day 1 and 0 at Day 4, in the 25mg arm was 5 at Day 1 and 2 at Day 4, in the 50mg arm was 2 at Day 1 and 3 at Day 4.~Values listed as 0 were non-estimable values."|||h*ng/mL|Participants|Geometric Coefficient of Variation|Geometric Mean
2622773|NCT01937117|Secondary|Changes in Ki67 With Response|To correlate baseline and change (day 15) in Ki67 with pCR|3 months||2020-09-30|09/2020||||
2622774|NCT01937117|Secondary|Change in PI3K Pathway Activation With Response|To correlate PI3K pathway activation (e.g. PTEN low and/or PIK3CA mutation, human epidermal growth factor receptor (HER) 1-4 expression and/or phosphorylation) in tumor samples and pCR|3 months||2020-09-30|09/2020||||
2622775|NCT01937117|Secondary|Change in ptDNA With Response|To correlate PIK3CA mutation status and other genomic alterations (mutations/somatic rearrangements) qualitatively and quantitatively in plasma tumor DNA (ptDNA) with pCR|3 months||2020-09-30|09/2020||||
2622776|NCT01937117|Primary|Percent Change in Standardized Uptake Value (SUV) as Measured by SULmax on [18F]Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)|SULmax is the maximum SUV corrected for lean body mass. Change in SULmax from baseline to Day 15 on FDG PET in correlation with pathological complete response (pCR) in patients treated with preoperative pertuzumab/trastuzumab. pCR was defined as no viable invasive cancer in breast and axilla by local pathology review. SULmax was measured via spherical volume over the target primary breast cancer tissue.|Baseline and Day 15|Data was evaluable in only 83/88 participants.|||percent reduction in SULmax||Standard Deviation|Mean
2622777|NCT01937026|Primary|PK: Area Under the Concentration Curve From Time 0 to Infinity [AUC (0-∞)] of Baricitinib||Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + probenecid in Period 2) and had PK data to calculate AUC (0-∞) of baricitinib.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2622778|NCT01937026|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib||Days 1 and 5: predose of baricitinib, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 and 72 (Day 5 dosing only) hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + probenecid in Period 2) and had PK data to calculate Cmax of baricitinib.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2622779|NCT01936974|Primary|Progression-free Survival|Evaluate progression-free survival between the two regimens.|One Year|Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained.||||||
2622780|NCT01936909|Secondary|Death or Hospital Admission for Heart Failure|We will monitor survival and hospitalization for heart failure throughout the 24 week follow-up|24 weeks|All analyses were restricted to patients with a minimum of 2 weeks follow-up.|||participants|||Number
2622781|NCT01936909|Secondary|Quality of Life Improvement|The Duke Activity Status Index questionnaire will be completed at enrollment and 12 weeks. The scale ranges from 0 (unable to perform any tasks) to 58.20 (able to perform all tasks). Higher scores represent increased ability to perform daily activities and may be interpreted as improved quality of life.|12 weeks|Patients with baseline and follow-up data|||units on a scale||Inter-Quartile Range|Median
2622782|NCT01936909|Primary|Interval Changes in Peak Oxygen Consumption (VO2)|Interval changes in peak oxygen consumption (VO2) after 2 weeks of anakinra treatment.|Baseline to 2 weeks|Patients who completed baseline and 2 week exercise evaluation|||mL/kg/min||Inter-Quartile Range|Median
2622783|NCT01936896|Other Pre-specified|Safety|We will record the number of participants with all adverse events (cardiac and non-cardiac) over the 3 months, including infusion reactions and drug-related issues.|3 months|||||||
2622784|NCT01936896|Secondary|Left Ventricular End-systolic Volume Change|We will calculate the interval change between admission and 3 months in left ventricular end-systolic volume, using echocardiography|3 months|Only 5 patients had paired (i.e. baseline and 3 months) echocardiograms for evaluation|||mL||Inter-Quartile Range|Median
2622785|NCT01936896|Primary|C Reactive Protein (Area Under the Curve)|A single area under the curve (AUC) calculation based upon C-reactive protein (CRP) values drawn at baseline, 3 days, and 14 days.|14 days||||mg/L||Inter-Quartile Range|Median
2622812|NCT01936467|Primary|Sensitivity of EUS-FNA With Capillary Technique|Sensitivity of the EUS-FNA with Capillary technique|6 months|The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.|||participants|||Number
2622813|NCT01936467|Primary|Diagnostic Yield of Standard Technique|Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.|up to 6 months||||percentage of specimen|||Number
2622786|NCT01936870|Secondary|Change From Baseline in the Overactive Bladder Symptom Score (OABSS)|Overactive Bladder Symptom Score (OABSS) was defined as the sum score (0 to 15) of the following four OAB symptoms: daytime frequency (2 at maximum), nighttime frequency (3 at maximum), urgency (5 at maximum), and urgency incontinence (5 at maximum). Higher score indicates worse symptoms. Mean change from baseline in the OABSS at 12 weeks was presented along with the corresponding standard deviation.|Baseline, 12 Weeks|The effectiveness analysis set comprised of participants from the safety analysis set who had effectiveness evaluation at least once after treatment with fesoterodine fumarate, excluding those with off-label use. Participants with observed change in OABSS were included in table.|||Scale||Standard Deviation|Mean
2622787|NCT01936870|Secondary|Satisfaction Rate|Satisfaction rate, which was defined as the percentage of participants who were satisfied by fesoterodine fumarate treatment over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Satisfaction scale was assessed by the participants according to the following categories: (1) satisfied, (2) unsatisfied, (3) uncertain, or (4) unconfirmed.|12 Weeks|The effectiveness analysis set comprised of subjects from the safety analysis set who had effectiveness evaluation at least once after treatment with fesoterodine fumarate, excluding those with off-label use.|||Percentage||95% Confidence Interval|Number
2622788|NCT01936870|Primary|Clinical Efficacy Rate|Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall effectiveness of fesoterodine fumarate was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable at week 12 of the treatment.|12 Weeks|The effectiveness analysis set comprised of subjects from the safety analysis set who had effectiveness evaluation at least once after treatment with fesoterodine fumarate, excluding those with off-label use.|||Percentage||95% Confidence Interval|Number
2622789|NCT01936870|Secondary|Number of Participants With Treatment-Related Adverse Events Among Whose Dose Was Increased From 4 mg to 8 mg|A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.|12 Weeks|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.|||Participants|||Number
2622790|NCT01936870|Secondary|Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP3A4 or CYP2D6 Inhibitors|Cytochrome P450 3A4 (CYP3A4) inhibitors included atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, ritonavir, saquinavir, and telithromycin. Cytochrome P450 2D6 (CYP2D6) inhibitors included quinidine and paroxetine. A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.|12 Weeks|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.|||Participants|||Number
2622791|NCT01936870|Secondary|Change From Baseline in the Mini-Mental State Examination (MMSE) Score|Mini-Mental State Examination (MMSE) measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state. Mean change from baseline in the MMSE score at 12 weeks was presented along with the corresponding standard deviation.|Baseline, 12 Weeks|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once. Participants with observed change in MMSE score were included in table.|||Scale||Standard Deviation|Mean
2622792|NCT01936870|Secondary|Number of Participants With Adverse Events Related to Cognitive Function Disorder|An adverse event was any untoward medical occurrence in a participant who received fesoterodine fumarate without regard to possibility of causal relationship. Adverse events related to cognitive function disorder were identified by broad searches on the Standard MedDRA Queries (SMQ).|12 Weeks|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.|||Participants|||Number
2622793|NCT01936870|Secondary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to fesoterodine fumarate was assessed by the investigator.|12 Week|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.|||Participants|||Number
2622794|NCT01936870|Secondary|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to fesoterodine fumarate was assessed by the investigator.|12 Week|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.|||Participants|||Number
2622795|NCT01936870|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.|12 Week|The safety analysis set comprised of participants who had satisfied the inclusion criteria of the study, and who had received fesoterodine fumarate at least once.|||Participants|||Number
2622814|NCT01936467|Primary|Diagnostic Yield of Capillary Technique|Diagnostic yield is defined as percentage of specimens in which diagnostic material is obtained.|up to 6 months||||percentage of specimen|||Number
2622796|NCT01936844|Secondary|Brachial Artery Vasoreactivity|Change in flow mediated vasodilatation (FMD) of the brachial artery. Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia (an increase in the quantity of blood flow to a body part) induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter. The change is FMD is reported as the % change in FMD from baseline to 14 days.|14 days|Some patients did not undergo assessment at 14 days because they did not show up to their scheduled appointment.|||percentage change||Inter-Quartile Range|Median
2622797|NCT01936844|Secondary|Left Ventricular Ejection Fraction|Change in left ventricular ejection fraction (LVEF) between admission and 14 day follow up. This value is expressed as absolute change in measured LVEF. For example, if baseline LVEF = 20% and 14 day LVEF = 25%, this would be reported as an absolute change of 5%.|14 days|Some patients did not undergo LVEF assessment at 14 days because they did not show up to their scheduled appointment.|||percent LVEF||Inter-Quartile Range|Median
2622798|NCT01936844|Primary|C Reactive Protein|"The proportional area-under-the-curve for plasma C reactive protein (CRP) levels measured during the first 3 days of admission. The proportion (y-axis) is calculated at each time-point with respect to the baseline CRP. The resultant y-axis is a unitless proportion. The x-axis is listed as days"|3 days|1 patient in each group withdrew from the study prior to collection of data for the primary endpoint.|||days||Inter-Quartile Range|Median
2622799|NCT01936662|Secondary|OR to Discharge (Min)|Overall time from arrival in the OR to discharge home (in minutes)|OR to discharge||||Minutes||Standard Deviation|Mean
2622800|NCT01936662|Primary|Endoscopist Satisfaction|"Endoscopist was surveyed to determine their satisfaction with each of the airway devices.~Endoscopist used the following satisfaction scale for each patient, regardless of the airway device used:~The airway device did not interfere at all with the ability to perform the scope.~The airway device presented some interference with the scope, but not enough to cause difficulty.~The airway device made it difficult to perform the endoscopy.~The airway device prevented the endoscopy from being performed."|2 hours||||units on a scale||Standard Deviation|Median
2622801|NCT01936649|Secondary|To Assess the Test-retest Reproducibility of Iobenguane I 123 Injection Myocardial Uptake on Planar Imaging at 15 Minutes Following Administration of AdreView (Iobenguane I 123 Injection)|Measurements of H/M ratio and the extent of difference between H/M measurements following AdreView administration and 15 minutes delayed planar imaging on 2 separate days within an interval of 5 to 14 days, was used to assess the test-retest reproducibility. Data from test-retest study was used to estimate the normal ranges for variation in quantitation of myocardial tracer uptake using AdreView. H/M ratios were calculated by 3 technologists and average of 3 technologists was calculated based on non-missing technologists reviewing results. All non-missing technologist evaluations were averaged per participant.|15 minutes post administration of 2 dosing within an interval of 5 to 14 days|Efficacy population that included all participants who underwent 2 administrations of AdreView; had at least an interpretable planar image acquisition at 15 minutes post-injection after each AdreView administration. Here, 'n' signifies number of participants analyzed by the technologist.|||Ratio||Standard Deviation|Mean
2622802|NCT01936649|Primary|To Assess Test-retest Reproducibility of Iobenguane I 123 Injection Myocardial Uptake in Heart Failure (HF) Participants on Planar Imaging at 3 Hours 50 Minutes Following I.V. Injection of AdreView (Iobenguane I 123 Injection)|Participants underwent 2 AdreView (Iobenguane I 123 Injection) exams on the same gamma camera within 5 to 14 days, with the requirement that there was no change in the clinical condition of the participant or in the imaging equipment between the 2 procedures. Each imaging study was processed and read independently by 3 technologists. Mean heart/mediastinum (H/M) ratio difference (with 95% confidence interval [CI]) was used as the measure of test stability.|3 Hours 50 Minutes post administration of 2 dosing within an interval of 5 to 14 days|Efficacy population that included all participants who underwent 2 administrations of AdreView (Iobenguane I 123 Injection); had at least an interpretable planar image acquisition at 3 hours 50 minutes post-injection after each AdreView administration. Here, 'n' signifies number of participants analyzed by the technologist.|||Ratio||Standard Deviation|Mean
2622803|NCT01936623|Other Pre-specified|Number of Subjects Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids|Radioimmunoassay Testing (RIA) was conducted|6-month follow-up|Hair samples were missing due to refusal, insufficient quantity, and missing follow-up interview.|||Participants|||Count of Participants
2622804|NCT01936623|Other Pre-specified|Number of Subjects Testing Positive on Hair Testing for Marijuana, Cocaine, Amphetamines, or Opioids.|Radioimmunoassay (RIA) Tests were used.|3-month|Hair samples were missing due to refusal, insufficient quantity, and missing follow-up interview.|||Participants|||Count of Participants
2622805|NCT01936623|Secondary|Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score|The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk.|6-month follow-up||||units on a scale||Standard Error|Least Squares Mean
2622806|NCT01936623|Primary|Alcohol, Smoking, and Substance Involvement Screening Tests (ASSIST) Global Continuum of Illicit Drug Risk Score|The ASSIST Global Continuum of Illicit Drug Risk Score ranges from 0 to 308, with higher scores indicating greater risk.|3 month follow-up||||units on a scale||Standard Error|Least Squares Mean
2622807|NCT01936467|Secondary|Diagnostic Accuracy of EUS-FNA|The proportion of subjects without the disease with negative EUS-FNA in total of subjects without the disease|6 months||||percent accurate|||Number
2622808|NCT01936467|Secondary|Acquisition of Core Tissue|The rate of acquiring core tissue of the pancreatic mass through EUS-FNA|immediate||||participants|||Number
2622809|NCT01936467|Secondary|First Pass Diagnostic Rate|The rate of aquiring diagnostic pancreatic mass tissue with first FNA pass|immediate||||participants|||Number
2622810|NCT01936467|Primary|Sensitivity of EUS-FNA|Comparison of EUS-FNA sensitivity using Capillary technique versus Standard technique for pancreatic solid lesions|6 months|The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.|||percentage of positive gold standard|||Number
2622811|NCT01936467|Primary|Sensitivity of EUS-FNA With StandardTechnique|Sensitivity of the EUS-FNA with Capillary technique|6 months|The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that calculation of sensitivity was done based on the Per Protocol analysis.|||Participants|||Number
2622819|NCT01936363|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation of Treatment and Death|TEAEs, Serious TEAEs and AEs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0. An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A Serious Adverse Event was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to data cut-off that were absent before treatment or that worsened relative to pretreatment state.|First dose of study drug up to 52 months|Safety population (SAF) analysis set included all participants who received at least one dose of any trial treatment.|||Participants|||Count of Participants
2622820|NCT01936363|Secondary|Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Ovarian-Specific Module Quality of Life Questionnaire Ovarian Cancer Module (QLQ-OV28)|EORTC QLQ-OV28 assesses disease and treatment-related symptoms of ovarian cancer. The 28-item module comprises of 6 symptom scales (abdominal/gastrointestinal symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal symptoms, body image, attitude to disease and treatment), and sexual functioning. All of the scales and the individual single-items ranged in score from 0 to 100. Higher scores indicate a better quality of life.|Baseline up to disease progression or withdrawal, assessed up to 52 months|Data was not collected for this outcome because as per Protocol Amendment 4 (dated 13 March 2015), the collection of patient-reported health-related quality of life outcomes was discontinued.||||||
2622821|NCT01936363|Secondary|Health Related Quality of Life (HrQoL) Assessed Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)|EORTC QLQ-C30 is a 30-item questionnaire comprising of five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and a global quality of life (QoL) scale summarized from two 7-point scales (overall QoL and overall general health). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and the individual single-items ranged in score from 0 to 100. A high scale score represents a higher response level. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.|Baseline up to disease progression or withdrawal, assessed up to 52 months|Data was not collected for this outcome because as per Protocol Amendment 4 (dated 13 March 2015), the collection of patient-reported health-related quality of life outcomes was discontinued.||||||
2622822|NCT01936363|Secondary|Overall Survival|Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number participants who died and number of censored participants.|Time from randomization until death, assessed up to 52 months|ITT analysis set included all participants who had been randomized.|||Participants|||Count of Participants
2622823|NCT01936363|Secondary|Percentage of Participants With Disease Control|Disease control as per RECIST v.1.1 was defined as the proportion of participants with stable disease (SD), for at least 16 weeks, PR or CR according to RECIST v1.1 criteria. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: At least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.|Randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to 52 months|ITT analysis set included all participants who had been randomized.|||percentage of participants||95% Confidence Interval|Number
2622824|NCT01936363|Secondary|Progression-Free Survival|PFS defined as time from randomization to first documentation of objective tumor progression.CR:Disappearance of all target lesions.Any pathological lymph nodes(whether target or non-target)must have reduction in short axis to<10 mm.PR:At least 30% decrease in sum of diameters of target lesions,taking as reference baseline sum diameters.PD:At least a 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study.In addition to relative increase of 20%,the sum also demonstrate absolute increase of at least 5 mm.SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference smallest sum diameters while on study. PFS calculated as(Months)=first event date minus randomization or first dose date plus 1.Median PFS was computed using Kaplan-Meier estimates (product-limit estimates) and was presented with 95% confidence interval.The confidence intervals for median was calculated according to Brookmeyer and Crowley.|Time from randomization until first observation of progressive disease or death, assessed up to 52 months|ITT analysis set included all participants who had been randomized.|||months||95% Confidence Interval|Median
2622825|NCT01936363|Primary|Objective Tumor Response|Objective tumor response was defined as the presence of at least one Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to more than (<) 10 millimeter (mm). Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|From randomization until disease progression or death assessed every 8 weeks up to week 32, and thereafter every 12 weeks up to 52 months|ITT analysis set included all participants who had been randomized.|||percentage of participants||95% Confidence Interval|Number
2622845|NCT01935947|Primary|Percentage of Patients Progression-free at 6 Months From the Time of Randomization|The final analysis will be by Fisher's Exact test, with percentage of patients who have not progressed as the outcome variable. Using Fisher's Exact test for analysis with 55 patients per treatment group will provide 88% power to detect an increase from 40% (chemotherapy alone) to 65% (epigenetic therapy followed by chemotherapy) in the number of patients who are progression free at six months.|At 6 months|Data was not collected to assess this outcome measure due to early study termination.||||||
2622826|NCT01936324|Primary|Percentage of Subjects Who Achieved ≥ 2-grade Improvement in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 in Phase 2a|"Percentage of subjects who achieved ≥ 2-grade improvement in the investigator global assessment of acne (IGA) from baseline to Week 12 in Phase 2a~Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions~- Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion~- Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions)~- Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion~- Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions"|Baseline and Week 12|Intent-to-Treat|||Participants|||Count of Participants
2622827|NCT01936324|Primary|Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 in Phase 2a|Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12 in Phase 2a|Baseline and Week 12|Intent-to-Treat|||Lesions||Standard Error|Least Squares Mean
2622828|NCT01936324|Primary|Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 in Phase 2a|Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12 in Phase 2a|Baseline and Week 12|Intent-to-Treat|||Lesions||Standard Error|Least Squares Mean
2622829|NCT01936259|Secondary|Number of Shoulders Passing Radiographic Assessment of Radiolucencies and Subsidence|All radiographs collected at all follow-up time points were analyzed by the Independent Radiographic reviewer. Subjects were assessed for the presence of radiolucencies considered to be failures of the radiographic co-primary endpoint (No progressive lucency around the humeral component >2 mm in two or more contiguous zones OR no progressive lucency >2 mm around the entire glenoid component) and for the presence of component subsidence. Subjects with the absence of failing radiolucencies and subsidence were considered successes.|2+ years|All subject radiographs at all time points that were submitted to the Independent Radiographic Reviewer were analyzed.|||Shoulders|Shoulders||Count of Units
2622830|NCT01936259|Secondary|Constant Score Adjusted for Age and Gender|The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The standard score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function. The age- and gender-adjusted Constant score normalizes the raw Constant score based on the subject's age and gender. The worst score on the adjusted scale is still 0, but the greatest scores can exceed 100 based on the calculations used for normalization. The scale used in this study was described by Katolik et al.|Pre-operative, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years|All subjects with a Constant score collected at each specified study time period were assessed. The score was not collected at 6 weeks to protect the subscapularis repair.|||score on a scale|Shoulders|Standard Deviation|Mean
2622831|NCT01936259|Secondary|Single Assessment Numeric Evaluation (SANE) Score|The Single Assessment Numeric Evaluation (SANE) Score is a tool used to assess the subject's perception of their affected joint. Participants are requested to rate their shoulder function on a scale of 0 to 100, with 0 as the worst option and 100 being normal shoulder function.|6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years|All subjects with a SANE score collected at each specified study time period were assessed.|||score on a scale|Shoulders|Standard Deviation|Mean
2622832|NCT01936259|Secondary|American Shoulder and Elbow Surgeon's Score (ASES)|The American Shoulder and Elbow Surgeon's (ASES) Score is a tool used to measure shoulder function. The ASES score is on a scale of 0 to 100, with 0 being the worst possible score and 100 the best. The score consists of two components - pain and activities of daily living.|Pre-operative, 6 Weeks, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years|All subjects with an ASES score collected at each specified study time period were assessed.|||score on a scale|Shoulders|Standard Deviation|Mean
2622833|NCT01936259|Primary|Number of Shoulders With Radiographic Success|"This outcome measure calculates the proportion of subjects meeting a success criteria defined in the protocol as Subsidence of the humeral component <5 mm, and migration of the humeral component <5 mm, and no progressive lucency around the humeral component >2 mm in two or more contiguous zones, and migration of the glenoid component <5 mm, and no progressive lucency >2 mm around the entire glenoid component. All subject records were evaluated by an Independent Radiographic Reviewer (IRR) at each time point for radiographic success based on these criteria."|2 years|All subjects at each time point were evaluated for radiographic success based on these criteria.|||Shoulders|Shoulders||Count of Units
2622834|NCT01936259|Primary|Number of Shoulders With Absence of Revision/Removal/UADE/Fracture/Dislocation|"This outcome measure calculates the proportion of subjects meeting a success criteria defined in the protocol as No unanticipated device-related adverse event, and no fracture, perforation of the bone or joint dislocation, and no fracture, perforation or dissociation of the device, and no revision or removal of any component. All subject records were evaluated for each of the disqualifying factors, and all subjects that failed at least one of the endpoint measures were identified. The success rate is defined as the number of subjects at two years not meeting any of the disqualifying factors compared to the total number of cases present at two years plus all subjects considered failures without two year data."|2 years|The total number of cases for each group includes all subjects with two year data, plus all subjects considered failures without two year data.|||Shoulders|Shoulders||Count of Units
2622835|NCT01936259|Primary|American Shoulder and Elbow Surgeon's Score (ASES)|The American Shoulder and Elbow Surgeon's (ASES) Score is a tool used to measure shoulder function. The ASES score is on a scale of 0 to 100, with 0 being the worst possible score and 100 the best. The score consists of two components - pain and activities of daily living.|22+ Months|All subjects with ASES data available at the two year visit were assessed.|||score on a scale|Shoulders|Standard Deviation|Mean
2622836|NCT01936181|Secondary|Disease Activity Score Based on a 28 Joint Count (DAS28)||Week 30, Week 54, Week 78|||||||
2622837|NCT01936181|Secondary|American College of Rheumatology 50% Response Criteria (ACR50)||Week 30, Week 54, Week 78|||||||
2622838|NCT01936181|Secondary|ACR20||Week 54, Week 78||||percentage of participants|||Number
2622839|NCT01936181|Primary|American College of Rheumatology 20% Response Criteria (ACR20)||Week 30||||percentage of participants|||Number
2622840|NCT01935947|Other Pre-specified|Response to Therapy Compared to Genetic and Epigenetic Factors and Tested for Association||After 1 month of therapy|Data was not collected to assess this outcome measure due to early study termination.||||||
2622854|NCT01934894|Secondary|CNS Progression Free Survival|Evaluate the three and six-month CNS progression free survival measured from date of first protocol treatment until tumor progression or death.|every 6 weeks thru cycle 8, then every 9 weeks until treatment discontinuation, projected 1 year|No data was collected for this outcome measure.||||||
2622855|NCT01934894|Secondary|Extra-Cranial Objective Response|The number of participants having Complete and Partial Responses (CR+PR) of extra-cranial lesions assessed per RECIST v1.1 Criteria. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion.|every 6 weeks for 8 cycles, then every 9 weeks until treatment discontinuation, up to 1 year||||Participants|||Count of Participants
2622856|NCT01934894|Secondary|CNS Clinical Benefit Response|The number of patients with Complete Response, Partial Response or Stable Disease extending beyond 6 months (CR+PR+SD ≥ 6 months), determined by RECIST v1.1. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion; SD=Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since the treatment started.|every 6 weeks thru cycle 8, and every 3 cycles thereafter until treatment discontinuation, projected 1 year||||Participants|||Count of Participants
2622857|NCT01934894|Primary|Number of Participants Who Experience Dose-Limiting Toxicities (DLTs) as a Measure of Safety|During the safety lead-in, a standard 3+3 dose escalation design is used to determine the maximum tolerated dose (MTD) of cabazitaxel with lapatinib. The MTD would be determined by the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) during 1 cycle (21 days) of therapy. If 2 of 6 patients within a dose level experiences a DLT, that dose level would be defined as exceeding the MTD and the previous dose level would be evaluated. DLTs are assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.|weekly for 3 weeks||||Participants|||Count of Participants
2622858|NCT01934894|Primary|Maximum Tolerated Dose of Cabazitaxel With Lapatinib|The maximum tolerated dose (MTD) of cabazitaxel and lapatinib will be determined as the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. A listing of DLTs are reported in the subsequent Primary Outcome Measure.|weekly for 3 weeks|Includes all treated participants, either at Dose Level 1 or Dose Level 2|||mg/m^2 of cabazitaxel + lapatinib|||Number
2622859|NCT01934894|Primary|CNS Objective Response|The number of patients with Complete and Partial Response (CR+PR) of CNS lesions assessed per modified RECIST Criteria for Evaluation of Intracranial Disease. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion.|every 6 weeks thru cycle 8, then every 9 weeks until treatment discontinuation, projected 1 year|Includes all treated participants|||Participants|||Count of Participants
2622860|NCT01934790|Post-Hoc|Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score Worsened to >=3 During the Follow-up Period||Up to 2 years after last treatment|Active Follow-up Analysis Set: participants who were reported in the End of Treatment (EOT) electronic case report form (eCRF) as planning to participate in the active follow-up.|||Participants|||Number
2622861|NCT01934790|Post-Hoc|Number of Participants With Body Weight Changes During the Follow-up Period|Participants were counted once during active follow-up for both increases (using the maximum body weight) and decreases (using the minimum body weight).|Up to 2 years after last treatment|Active Follow-up Analysis Set: participants who were reported in the End of Treatment (EOT) electronic case report form (eCRF) as planning to participate in the active follow-up.|||Participants|||Number
2622862|NCT01934790|Post-Hoc|Number of Participants With Significant Meaningful Changes for Clinical Laboratory NCI-CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) Toxicity Grades During the Follow-up Period||Up to 2 years after last treatment|Active Follow-up Analysis Set: participants who were reported in the End of Treatment (EOT) electronic case report form (eCRF) as planning to participate in the active follow-up.|||Participants|||Number
2622863|NCT01934790|Post-Hoc|Number of Deaths During Study Treatment or Follow-up Period||Up to 2 years after last treatment|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Participants|||Number
2622864|NCT01934790|Post-Hoc|Number of Participants With New Primary Malignancies During Study Treatment or Follow-up Period||Up to 2 years after last treatment|Active Follow-up Analysis Set: participants who were reported in the End of Treatment (EOT) electronic case report form (eCRF) as planning to participate in the active follow-up.|||Participants|||Number
2622865|NCT01934790|Post-Hoc|Number of Participants With New SSE Related AEs During the Follow-up Period||Up to 2 years after last treatment|Active Follow-up Analysis Set: participants who were reported in the End of Treatment (EOT) electronic case report form (eCRF) as planning to participate in the active follow-up.|||Participants|||Number
2622866|NCT01934790|Other Pre-specified|SSE-free Survival|The SSE-FS is the time (days) from the treatment start date to the first SSE on or following the start date or death, whichever occurred first. Participants not experiencing death or an SSE at the database cutoff date for primary completion were censored at the last assessment for SSEs.|Up to 2 years after last treatment|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2622867|NCT01934790|Other Pre-specified|Time to First Symptomatic Skeletal Event (SSE)|Time to first symptomatic skeletal event (SSE) is the time (days) from the treatment start date to the first SSE on or following the start date. Participants not experiencing an SSE at the database cutoff date for primary completion, whether or not surviving, were censored at the last assessment for SSEs.|Up to 2 years after last treatment|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2623470|NCT01930487|Secondary|Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio)|change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
2622868|NCT01934790|Other Pre-specified|Time to Pain Progression|Pain progression was defined in participants evaluable for pain progression at baseline, i.e., participants with a WPS of ≤ 7 at the baseline assessment. Pain assessment occurred daily for 1 week, beginning 1 week prior to each visit and including the day of the visit. An evaluable pain assessment interval required completion of a minimum of 4 out of 7 daily questions. Pain progression was defined as the occurrence of either a pain increase or an increase in pain management with respect to baseline, whichever occurred first.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2622869|NCT01934790|Other Pre-specified|Percentage of Participants With Pain Improvement|Pain improvement was defined in evaluable participants (participants with worst pain score [WPS] of 4 at baseline) as a 30% and 2-point decrease in WPS over 2 consecutive measurements conducted at least 4 weeks apart, without an increase in pain management. Pain improvement rate was the number of participants with pain improvement, divided by the total number of evaluable participants WPS was the mean of the WPS in the last 24 hours from the preceding 7 days.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2622870|NCT01934790|Other Pre-specified|Overall Survival|Overall survival (OS) was defined as the time (days) from the treatment start date to the date of death due to any cause. For participants who were still alive or who were lost to follow-up as of the database cutoff date for the primary completion, OS was censored at the last known alive date on or prior to the database cutoff date.|Up to 2 years after last treatment|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2622871|NCT01934790|Other Pre-specified|Time to PSA Progression|Prostate specific antigen progression was defined as a ≥ 25% increase above the nadir (lowest baseline or post-baseline) value, and an increase in absolute value of ≥ 2 ng/mL above nadir. The time to PSA progression was defined as the time (days) from the treatment start date to the date of first PSA progression. Participants without PSA progression as of the database cutoff for primary completion, whether or not surviving, were censored at the last PSA laboratory assessment.|Up to 2 years after last treatment|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2622872|NCT01934790|Other Pre-specified|Percentage of Participants With Prostate Specific Antigen (PSA) Response|Prostate specific antigen (PSA) response was defined as a ≥ 30% reduction of blood PSA level compared with the baseline value, confirmed by a second subsequent PSA value with a ≥ 30% reduction from baseline approximately 4 or more weeks later. Prostate specific antigen response rate was defined as the number of participants with PSA response divided by the total number of participants evaluable for PSA response.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2622873|NCT01934790|Other Pre-specified|Percent Change in Total ALP||Baseline and Week 12, Week 24|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Percent change||Standard Deviation|Mean
2622874|NCT01934790|Other Pre-specified|Time to Total ALP Progression|Total ALP progression was defined as a ≥ 25% increase above the nadir (lowest baseline or post-baseline) value to at least 1.5 x ULN (upper limit of normal). The time to total ALP progression was defined as the time (days) from the treatment start date to the date of first total ALP progression. Participants not experiencing ALP progression at the database cutoff date, whether or not surviving, were censored at the last ALP laboratory assessment.|Up to 2 years after last treatment|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2622875|NCT01934790|Other Pre-specified|Percentage of Participants With Total Alkaline Phosphatase (ALP) Response|Total alkaline phosphatase (ALP) response was defined as ≥ 30% reduction of the blood total ALP level compared with the baseline values. Total ALP response rate was defined as the number of participants with total ALP response divided by the total number of participants evaluable for total ALP response.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2622876|NCT01934790|Other Pre-specified|Time to Radiological Bone Progression|Time to radiological bone progression was defined as the time (days) from the treatment start date to the date of radiological bone progression (according to the adapted PCWG2 [Prostate Cancer Clinical Trials Working Group 2] criteria), as documented by the investigator. Participants not experiencing radiological bone progression at the database cutoff for primary completion were censored at the last radiological bone progression assessment.|Up to 2 years after last treatment|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2622877|NCT01934790|Other Pre-specified|Radiological Progression Free Survival (rPFS)|Radiological progression-free survival (rPFS) was defined as the time from the treatment start date to the date of radiological disease progression or death from any cause (if death occurred before such progression), as documented by the investigator. Participants not experiencing death or radiological disease progression at the database cutoff for primary completion were censored at the last radiological disease progression assessment.|Up to 2 years after last treatment|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2622878|NCT01934790|Primary|Number of Participants Who Discontinued Radium-223 Dichloride Treatment Due to Treatment Emergent AEs or Death|An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. A treatment-emergent adverse events (TEAE) is defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of radium-223 dichloride.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Participants|||Number
2622879|NCT01934790|Primary|Number of Participants With High/Low Abnormalities in Biochemistry Variables at Any Visit After Treatment Start||Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Participants|||Number
2622880|NCT01934790|Primary|Number of Participants With High/Low Abnormalities in Hematology Variables at Any Visit After Treatment Start||Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Participants|||Number
2622881|NCT01934790|Primary|Number of Participants With Radium-223 Dichloride-related SAEs in the Active Follow-up Period|Treatment-related SAE is any SAE that, according to the investigator's causality assessment, is possibly or probably related to treatment with radium-223 dichloride.|Up to 2 years after last treatment|Active Follow-up Analysis Set: participants who were reported in the End of Treatment (EOT) electronic case report form (eCRF) as planning to participate in the active follow-up.|||Participants|||Number
2622882|NCT01934790|Primary|Number of Participants With Radium-223 Dichloride-related AEs in the Active Follow-up Period|An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study.|Up to 2 years after last treatment|Active Follow-up Analysis Set: participants who were reported in the End of Treatment (EOT) electronic case report form (eCRF) as planning to participate in the active follow-up.|||Participants|||Number
2622883|NCT01934790|Primary|Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)|TESAE occurred after the start of radium-223 dichloride treatment until 30 days after the last dose and results in death; is life-threatening; requires inpatient hospitalization or prolongs existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly / birth defect; is another medically important serious event as judged by the investigator; or is an occurrence of leukemia, myelodysplastic syndrome, aplastic anemia, myelofibrosis, and primary bone cancer or any other new primary malignancy, such as acute myeloid leukemia.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Participants|||Number
2622884|NCT01934790|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs)|An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom, or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. A treatment-emergent adverse events (TEAE) is defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of radium-223 dichloride.|Up to 2.5 years|Safety Analysis Set (SAF): all participants who received at least one dose of study drug.|||Participants|||Number
2622885|NCT01934647|Primary|Peak Percent Change From Baseline in Pulmonary Vascular Resistance (PVR) at the Highest Acutely Tolerated (HAT) Dose of MK-8892|PVR assessments were performed throughout the right heart catheterization (RHC). Peak PVR reduction was determined to occur if 2 consecutive PVR measurements were at least 20% greater than the nadir PVR measurement.|Baseline and up to 5 hours post-dose|Planned efficacy analysis could not be performed due to early study termination.||||||
2622886|NCT01934582|Secondary|To Compare the Adverse Event (AE) Profile of BID Versus TID Dosing.|AE diaries including 8 therapy-specific terms were collected during both BID and TID dosing to allow for comparison of events from both regimens. The therapy-specific events included: diarrhea, extremity pain, flushing, headache, hypotension, jaw pain, nausea, and vomiting.|The AEs were recorded for up to 50 days.||||percentage of subjects|||Number
2622887|NCT01934582|Secondary|To Assess 6-minute Walk Distance for Both Groups (BID and TID) 3 to 6 Hours Post-morning Dose.|The 6-minute walk test (6MWT) was conducted at PK Visits 1 and 2, and was performed between hours 3 to 6 post-morning dose to correlate with the predicted peak plasma concentration of oral treprostinil.|The 6MWT was conducted during BID dosing PK collection (up to 14 days prior to transitioning to TID dosing regimen [PK Visit 1]) and during TID dosing PK collection (up to 35 days after transitioning to TID dosing regimen [PK Visit 2]).||||Meters||Full Range|Mean
2622888|NCT01934582|Primary|To Assess the Pharmacokinetics (AUClast) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35 Days After Transitioning to TID Dosing (at PK Visit 2).|The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.|Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2)||||h*ng/mL||Full Range|Mean
2622889|NCT01934582|Primary|To Assess the Pharmacokinetics (Cmax, Cmin) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35|The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.|Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2)||||ng/mL||Full Range|Mean
2622890|NCT01934582|Primary|To Assess the Pharmacokinetics (Mean AM Dose) in Subjects During Twice Daily (BID) Dosing (up to 14 Days Prior to Transitioning to Three Times Daily [TID] Dosing Regimen at PK Visit 1) and up to 35 Days After Transitioning to TID Dosing (at PK Visit 2).|The PK sampling occurred over a 12-hour period in subjects during BID dosing (PK Visit 1) and during TID dosing (PK Visit 2). Prior to each PK sampling day, subjects must have been receiving a stable dose for at least 5 days.|Up to 14 days prior to transitioning to TID dosing regimen (PK Visit 1) and up to 35 days after transitioning to TID dosing regiment (PK Visit 2)||||mg||Full Range|Mean
2622891|NCT01934517|Primary|Overjet|Overjet: measured as the greatest horizontal distance from the labial surface of the lower central incisor to the most inferior point at the mesiodistal center of the upper central incisor|one year||||mm||95% Confidence Interval|Mean
2622892|NCT01934504|Secondary|Immunosuppression Associated Signature|"Definition of an immune signature associated with maintenance immunosuppression.~Due to early study termination, data was not available to evaluate this endpoint."|Baseline to 8 Weeks Post-Immunosuppression Withdrawal|No analyses were performed due to slow enrollment and early study closure.||||||
2622893|NCT01934504|Secondary|Tolerance Signature Versus Clinical Status|"Correlation of possible changes in the tolerance signature with changes in clinical status.~Due to early study termination, data was not available to evaluate this endpoint."|Baseline to Week 26|No analyses were performed due to slow enrollment and early study closure.||||||
2622894|NCT01934504|Secondary|Tolerance Signature Stability|"Measurement of the stability of a tolerance immune signature in patients with AAV over time.~Due to early study termination, data was not available to evaluate this endpoint."|Baseline to Week 26|No analyses were performed due to slow enrollment and early study closure.||||||
2622895|NCT01934504|Primary|Tolerance Biomarker Identification|"Identification of biomarkers associated with clinical tolerance in patients with ANCA-associated vasculitis by comparative immunophenotyping of individual leukocyte subsets from tolerant and non-tolerant patients with AAV.~Due to early study termination, data was not available to evaluate this endpoint."|Difference from baseline to week 26|No analyses were performed due to slow enrollment and early study closure.||||||
2622896|NCT01934231|Secondary|Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Participant at EOT (Day 8)|The investigator used the sample collected at the start of study treatment (trt) to isolate and identify the pathogenic bacteria. The sample collected at the EOT was used to evaluate the bact. response to the investigational product of each par. using the following classification: Bact. eradication (erad.), presumed bact. erad. and colonization were categorized as erad. Bact. persistence (pers.), presumed bact. pers. and superinfection were categorized as pers. Bact. erad. elimination of the pathogen (path.) after trt; presumed bact. erad.-resolution of signs/symptoms (s/s) after trt; colonization-resolution of s/s but initial path. still recovered from sample; bact. pers.-no improvement in s/s and initial path. was recovered from sample; presumed bact. pers.-no improvement in s/s and isolation of initial path. was impossible/not performed; superinfection-initial path. was eradicated but a new path. was recovered; unable to determine-bact. test could not be performed.|Day 8|Bacteriology PP Population: all participants in the PP Population, excluding the participants who were classified as “Unable to determine” for the bacteriological outcome and who had no identified pathogen at Day 1|||Participants|||Number
2622897|NCT01934231|Secondary|Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8|"The investigator used the sample collected at the start of study treatment (trt) to isolate and identify the pathogenic bacteria. The sample collected at the EOT was used to evaluate the bact. response to the investigational product of each path. If the same pathogen was not detected at the EOT, this pathogen was classified as eradication (E). If the same pathogen was detected at the EOT, this pathogen was classified as persistence (P)."|Day 8|Bacteriology PP Population: all participants in the PP Population, excluding the participants who were classified as “Unable to determine” for the bacteriological outcome and who had no identified pathogen at Day 1|||Participants|||Number
2622898|NCT01934231|Secondary|Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15|The investigator (or sub-investigator) categorized the severity of symptoms such as rhinorrhoea and bad mood/productive cough as none, mild/small amount (M/SA), or moderate or severe (M or S). For the nasal cavity finding of nasal/postnasal discharge (N/PD) the categozation was serous [containing serum]), mucopurulent (MU/SA [containing both mucus and pus]), and moderate or larger amount (M/LA). In cases in which both sides of the nasal cavity were affected and there was no difference in severity between the sides, the right-side results were recorded. If there was a difference in severity, the more severe-side results were recorded.|Baseline (BL), Day 4, Day 8, and Day 15|PP Population|||Participants|||Number
2622899|NCT01934231|Secondary|"Number of Participants With a Clinical Outcome of Cure at Both the End of Treatment and Test of Cure (EOT and TOC: Day 8 and Day 15)"|"Clinical assessment of acute bacterial rhinosinusitis was performed by the investigator (or subinvestigator) at the EOT (Day 8) and TOC (Day 15) on the basis of the following criteria: Cure is defined as sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy is needed. Failure is defined as no change or deterioration of the signs and symptoms or as additional antibiotic therapy being needed. The outcome was unable to be determined if no information was available regarding the signs and symptoms or, despite improvement of the signs and symptoms, the use of a non-study antibiotic was administered, indicating that there was a protocol deviation. In order to be categorized as cure, participants had to meet the criteria for cure at both Day 8 and Day 15."|Day 8 and Day 15|PP Population|||Participants|||Number
2622900|NCT01934231|Secondary|"Number of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT: Day 8)"|"Clinical assessment of acute bacterial rhinosinusitis was performed by the investigator (or subinvestigator) at the EOT (Day 8) on the basis of the following criteria: Cure is defined as sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy is needed. Failure is defined as no change or deterioration of the signs and symptoms or as additional antibiotic therapy being needed. The outcome was unable to be determined if no information was available regarding the signs and symptoms or, despite improvement of the signs and symptoms, the use of a non-study antibiotic was administered, indicating that there was a protocol deviation."|Day 8|PP Population|||Participants|||Number
2622901|NCT01934231|Primary|"Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC: Day 15)"|"Clinical assessment of acute bacterial rhinosinusitis was performed by the investigator (or subinvestigator) at TOC (Day 15) on the basis of the following criteria: Cure is defined as sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy is needed. Failure is defined as no change or deterioration of the signs and symptoms or as additional antibiotic therapy being needed. The outcome was unable to be determined if no information was available regarding the signs and symptoms or, despite improvement of the signs and symptoms, the use of a non-study antibiotic was administered, indicating that there was a protocol deviation."|Day 15|Per Protocol (PP) Population: all participants randomized to treatment who received the study drug for at least the first 3 days of study treatment in the Treatment Period and had evaluable data on both Day 8 and Day 15 with treatment compliance between 80% and 100% and no major protocol deviations|||Participants|||Number
2622902|NCT01934218|Post-Hoc|Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test at Week 26|Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline to week 26 was calculated as baseline minus week 26.|Baseline and Week 26|The post-hoc analysis plan pre-specified that only the change at week 26 in the Gel-One arm is intended to be analyzed.|||mm||95% Confidence Interval|Mean
2622903|NCT01934218|Primary|Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26|Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline through week 26 was estimated using a longitudinal model.|Baseline up to Week26||||mm||95% Confidence Interval|Mean
2622904|NCT01934192|Secondary|Derived Accumulation Ratio (RO) of GSK962040 Post Intolerance|To estimate the extent of accumulation after repeat dosing, the observed accumulation ratio (Ro) was assessed.|Baseline, Day 2, Day 3, Day 4|PK Population. data were not collected.||||||
2622905|NCT01934192|Secondary|Derived AUC Over the Dosing Period [AUC(0-tau)] of GSK962040 Post Intolerance|Blood samples for PK analysis were collected at Baseline, and at Day 2 and Day 4 post development of intolerance. AUC from time zero extrapolated to infinite time [AUC(0-inf)] was not analyzed.|Day 2 and Day 4|PK Population.|||min*mmol/l||Standard Deviation|Geometric Mean
2622906|NCT01934192|Secondary|Derived Tmax of GSK962040 Post Intolerance|Blood samples for PK analysis were collected at Day 2 and Day 4 post development of intolerance. Tmax was defined as time to maximum observed plasma concentration of Camicinal.NA indicates that data were not available. SD was not provided if n<3.|Day 2 and Day 4|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|||Hr||Full Range|Median
2622907|NCT01934192|Secondary|Log Transformed Derived Plasma Cmax of GSK962040 Post Intolerance|Blood samples for PK analysis were collected at Day 2 and Day 4 post development of intolerance. Cmax was defined as maximum observed plasma concentration of Camicinal. The analysis was performed on PK Population. NA indicates that data were not available. SD was not provided if n < 3.|Day 2 and Day 4|PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)|||Log (ng/mL)||95% Confidence Interval|Geometric Mean
2622908|NCT01934192|Secondary|Log Transformed Derived Plasma Cmax of GSK962040 Prior to Intolerance|Blood samples for PK analysis were collected at Day 2, Day 3, Day 4, Day 7 prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. Cmax was defined as maximum observed plasma concentration of Camicinal. The analysis was performed on PK Population. PK Population comprised of participants in the 'Safety' population for whom a PK sample of Camicinal was obtained and analyzed. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|Day 2, Day 3, Day 4, Day 7|PK Population.|||Log (ng/mL)||95% Confidence Interval|Geometric Mean
2622909|NCT01934192|Secondary|Total GRV for 24 hr Period|Total GRV for each 24 hr period up to 7 days were assessed to determine the effect of GSK962040 vs. Placebo upon the daily GRV. Intolerance was defined as start of the intolerance treatment. The total GRV for each 24hr period was the sum of all available GRV measurements during the period. The 24hr was counted using the same 24hr clock as for the collection of nutritional data.|Up to Day 7|ITT (exposed) Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)|||mL||Standard Deviation|Mean
2622910|NCT01934192|Secondary|Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes|The total number of vomiting, regurgitation and macroaspiration episodes were categorized separately for prior to and post intolerance. Intolerance was considered as start of intolerance treatment. Only the records with non-zero counts were listed.|up to 23 days|Enrolled Population|||Participants|||Number
2622911|NCT01934192|Secondary|GE Assessment as C60 Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG|GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using 3-OMG absorption method. C60 was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.|Baseline, Day 2, Day 3, Day 4|ITT (exposed) Population. Only those participants available at the pre-dose visit were analyzed.|||mmol/l||95% Confidence Interval|Geometric Mean
2622912|NCT01934192|Secondary|GE Assessment as AUC (0-60) and AUC (0-240) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG|GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using 3-OMG absorption method. AUC(0-60) and AUC (0-240) was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.|Baseline, Day 2, Day 3, Day 4|ITT (exposed) Population. Only those participants with data available at pre-dose visit were analyzed (represented by n=X in the category titles).|||min*mmol/l||95% Confidence Interval|Geometric Mean
2622913|NCT01934192|Secondary|GE Assessment as Cmax Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen|GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using acetaminophen absorption method. Cmax was calculated and data was presented for pre-dose Visit(day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.|Baseline, Day 2, Day 3, Day 4|ITT (exposed) Population. Only those participants with data available at pre-dose visit were analyzed.|||ng/mL||95% Confidence Interval|Geometric Mean
2622914|NCT01934192|Secondary|GE Assessment as AUC (0-60) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen|GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using acetaminophen absorption method. AUC (0-60) was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.|Day 2|ITT (exposed) Population. Only those participants with data available at pre-dose visit were analyzed.|||min*ng/mL||95% Confidence Interval|Geometric Mean
2622915|NCT01934192|Secondary|Time to Development of Feeding Intolerance|Time required for the development of feeding intolerance was calculated using Kaplan-Meier estimates for time variable. Median and quartiles were not calculable due to the small number of participants developing EN intolerance and mean and standard error of mean were presented.|Up to Day 7|ITT (exposed) Population. Two subjects in the Camicinal group and one subject in the placebo group had their last available GRV assessment done prior to first dose and are therefore excluded from this summary.|||Hr||Standard Error|Mean
2622916|NCT01934192|Secondary|Percentage of Participants That Became Intolerant|Percentage of participants that became intolerant was calculated. Those participants who developed intolerance were assessed to characterize gastric emptying (GE). Participants who did not develop intolerance were censored at the time of the last available Gastric Residual Volume (GRV) measurement.|Up to Day 7|ITT (exposed) Population. Two participants in the camicinal group and one participant in the placebo group had their last available GRV assessment done prior to first dose and are therefore excluded from this summary.|||Percentage of participants|||Number
2622917|NCT01934192|Secondary|Derived Tmax of 3-OMG Post Intolerance|Blood samples for PK analysis were collected at Day 2 or Day 3 (or very rarely at Day 4 - only if Day 2 or Day 3 sample could not be obtained) post development of intolerance. Tmax was defined as time to maximum observed plasma concentration of 3-OMG.|At Day 2|PK Population. Data for Tmax was not collected.||||||
2622918|NCT01934192|Secondary|Log Transformed C60 of 3-OMG|Blood samples for PK analysis were collected at Baseline and at Day 2 or Day 3 (or very rarely at Day 4 - only if Day 2 or Day 3 sample could not be obtained)prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. C60 was defined as observed plasma concentration at 60 min after administration of enteral feed with 3-OMG. The absorption profile of 3-OMG was used as an indirect measure of gastric emptying function. The analysis was performed on ITT (exposed) Population. Cmax was not analyzed. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|At Day 2|ITT (exposed) Population.|||Log (mmol/L)||95% Confidence Interval|Geometric Mean
2622919|NCT01934192|Secondary|Log Transformed AUC[0-60] of 3-O-methylglucose (3- OMG)|Blood samples for PK analysis were collected at Baseline, and at Day 2 or Day 3 (or very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. AUC[0-60] of 3-OMG was defined as area under the concentration-time curve from time zero to 60 min. and it was calculated as Log trapezoidal rule from concentration-time data. The absorption profile of 3-OMG was used as an indirect measure of gastric emptying function. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)|At Day 2|ITT (exposed) Population.|||Log [Min. into mmol/L (min*mmol/l)]||95% Confidence Interval|Geometric Mean
2622920|NCT01934192|Secondary|Log Transformed AUC[0-60] of Acetaminophen|Blood samples for PK analysis were collected at Baseline, and at 60 min. at Day 2 or Day 3 (or very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. AUC[0-60] of acetaminophen was defined as area under the concentration-time curve from time zero to 60 min. and it was calculated as Log trapezoidal rule from concentration-time data. The absorption profile of acetaminophen was used as an indirect measure of gastric emptying function. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)|At Day 2|ITT (exposed) Population.|||Log [min into ng/mL (min*ng/mL)]||95% Confidence Interval|Geometric Mean
2622921|NCT01934192|Secondary|Log Transformed Concentration at 60 Minutes (Min) (C60) and Maximum Observed Concentration (Cmax) of Acetaminophen (Prior to Intolerance)|Blood samples for pharmacokinetic (PK) analysis were collected at Baseline, and at Day 2 or at Day 3 (OR very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. C60 was defined as observed plasma concentration at 60 min after administration of enteral feed with acetaminophen and Cmax was defined as maximum observed plasma concentration of acetaminophen. The absorption profile of acetaminophen was used as an indirect measure of gastric emptying function. The analysis was performed on ITT (exposed) Population. Due to change in sampling schedule, samples were only obtained to 4 hours. Only those participants available at the specified time points were analyzed (represented by n= x in the category titles).|At Day 2|ITT (exposed) Population.|||Log [nanogram per milliliter (ng/mL)]||95% Confidence Interval|Geometric Mean
2622922|NCT01934192|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels|Blood samples were collected to evaluate change from Baseline in MCH values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||Picogram (PG)||Standard Deviation|Mean
2622923|NCT01934192|Secondary|Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count|Blood samples were collected to evaluate change from Baseline in RBC and reticulocytes values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||Tetra unit per liter (TI/L)||Standard Deviation|Mean
2622924|NCT01934192|Secondary|Change From Baseline in Mean Corpuscle Volume (MCV) Levels|Blood samples were collected to evaluate change from Baseline in MCV values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||Femtoliter (fL)||Standard Deviation|Mean
2622925|NCT01934192|Secondary|Change From Baseline in Hematocrit Level|Blood samples were collected to evaluate change from Baseline in hematocrit values at Baseline up to Day 7 and follow up (till day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||Fraction of 1||Standard Deviation|Mean
2622926|NCT01934192|Secondary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels|Blood samples were collected to evaluate change from Baseline in hemoglobin and MCHC values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||g/L||Standard Deviation|Mean
2622927|NCT01934192|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels|Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet and WBC values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||Giga unit per liter (gI/L)||Standard Deviation|Mean
2622928|NCT01934192|Secondary|Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values|Blood samples were collected to evaluate change from Baseline in calcium, chloride, carbon dioxide, glucose, potassium, sodium, BUN values at Baseline, up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||millimol per liter (mmol/L)||Standard Deviation|Mean
2622929|NCT01934192|Secondary|Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels|Blood samples were collected to evaluate change from Baseline in total and direct bilirubin, creatinine and uric acid values at Baseline, Day 2- Day 7 and at follow up (Till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||micromoles per Liter (µmol/L)||Standard Deviation|Mean
2622930|NCT01934192|Secondary|Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels|Blood samples were collected to evaluate change from Baseline in alk.phosp., ALT, AST and GGT values at Baseline, Day 1- Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||International Unit per liter (IU/L)||Standard Deviation|Mean
2622931|NCT01934192|Secondary|Change From Baseline in Albumin and Total Protein Levels|Blood samples were collected to evaluate change from Baseline in albumin and total protein values at Baseline, Day 2-7 and follow-up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||Gram per liter (g/L)||Standard Deviation|Mean
2622932|NCT01934192|Secondary|Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values|12-lead ECGs was done at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 and at follow up (till Day 23) that automatically calculates corrected QT (QTc), QTcF (QT duration corrected for heart rate by Fridericia's formula) and QTcB (QT duration corrected for heart rate by Bazett's formula) intervals. Three ECGs approximately 5 min apart were collected prior to dose 1and single recordings were made at other time points. On Day 1ECGs were collected at pre-dose (up to 6 hrs) and 2 hr post treatment. Number of participants with maximum increase from Baseline were collected and participants showed increase in 3 parameters namely QTc, QTcB and QTcF. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).|Up to 23 days|Safety Population.|||Participants|||Number
2622933|NCT01934192|Secondary|Change From Baseline in Heart Rate (HR)|HR was measured at Baseline, Day 1, up to 6 hrs pre-dose on Day 2-7 and at follow-up (till Day 23). The Baseline value was considered to be the participant's last available assessment prior to randomized treatment. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, HR was measured at Day 1 to Day 7 post-intolerance. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the SD was set to missing.|Up to 23 days|Safety Population.|||beats per minute (bpm)||Standard Deviation|Mean
2622934|NCT01934192|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured at Baseline, Day 1, up to 6 hrs pre-dose on Day 2-7 and at follow-up (till 23 days). The Baseline value was considered to be the participant's last available assessment prior to randomized treatment. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, SBP and DBP were measured at Day 1 to Day 7 post-intolerance. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n < 3 the standard deviation (SD) was set to missing.|Up to 23 days|Safety Population.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2623034|NCT01933789|Other Pre-specified|Group Differences - Stable Treatment Preference (Filter for Subgroup Analysis of Goal-concordant Care)|Binary variable indicating whether patient's treatment preference was stable between target visit (or baseline, if no 2-week questionnaire was returned) and 3 months.|3 months after target visit|Patients completing 3-month questionnaires.|||Participants|||Count of Participants
2622935|NCT01934192|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE.|up to 23 days|Safety Population. Safety Population comprised of all participants who received at least one dose one study treatment.|||Participants|||Number
2622936|NCT01934192|Secondary|Time to Delivery of 80 Percent Prescribed Calories Prior to Intolerance|Time required for the delivery of 80 percent prescribed calories prior to intolerance was calculated using Kaplan-Meier estimates for time variable. Prior to intolerance was defined as prior to start of intolerance treatment. Participants who did not reach delivery of 80 percent prescribed calories were censored at the last day on which they received randomized treatment and with available nutritional data.|Up to Day 7|ITT (exposed) Population|||Days||Inter-Quartile Range|Median
2622937|NCT01934192|Secondary|Average Percentage Goal Protein Delivered Prior to Development of Intolerance|The average percentage goal protein received via EN was defined as the percent of goal protein received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total protein received via EN during the on treatment period prior to intolerance divided by total prescribed protein. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal protein received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.|Up to Day 7|ITT (exposed) Population|||Percentage of goal protein||95% Confidence Interval|Mean
2622938|NCT01934192|Secondary|Average Percentage Goal Calories Delivered Prior to Development of Intolerance|The average percentage goal calories received via EN was defined as the percent of goal calories received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total calories received via EN during the on treatment period prior to intolerance divided by total prescribed calories. 'Prior to intolerance' means 'prior to start of intolerance treatment. The average percentage goal calories received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.|Up to Day 7|ITT (exposed) Population|||Percentage of goal calories||95% Confidence Interval|Mean
2622939|NCT01934192|Primary|Average Percentage Goal Volume Delivered Prior to Development of Intolerance for PP Population|The average percentage goal volume received via EN was defined as the percent of goal volume received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total volume received via EN during the on treatment period prior to intolerance divided by total prescribed volume. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal volume received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.|Up to Day 7|Per Protocol (PP) Population. PP Population comprised of all randomized participants who receive at least two doses of study treatment and have at least two days of evaluable nutritional data and also comply with the protocol.|||Percentage of goal volume||95% Confidence Interval|Mean
2622940|NCT01934192|Primary|Average Percentage Goal Volume Delivered Prior to Development of Intolerance for ITT Population|The average percentage goal volume received via EN was defined as the percent of goal volume received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total volume received via EN during the on treatment period prior to intolerance divided by total prescribed volume. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal volume received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% confidence interval (CI) were estimated and Analysis of Covariance (ANCOVA) model was used for analysis.|Up to Day 7|Intension To Treat [ITT (exposed)] Population. ITT (exposed) Population comprised of all randomized participants who received at least of one dose of study treatment.|||Percentage of goal volume||95% Confidence Interval|Mean
2622941|NCT01934140|Secondary|Booster Phase: Percentage of Participants With Meningococcal Disease From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)|Meningococcal disease describes infections caused by the bacterium Neisseria meningitidis (also termed meningococcus). It causes two life threatening diseases: meningococcal meningitis and fulminant meningococcemia which often occur together. Meningococcal meningitis is defined as an inflammatory response to bacterial infection of leptomeninges (pia-arachnoid) and the sub-arachnoid space. Meningococcal meningococcemia is meningococcal septicemia when the bacteria circulate and multiply in blood and involve multiple organs. It can cause multi-organ failure and severe disability or death.|Up to 6 months post booster vaccination|All eligible participants who received primary vaccination in study 107386 [NCT00356369] and received booster dose of vaccine in study MENACWY-099.|||percentage of participants|||Number
2622942|NCT01934140|Secondary|Booster Phase: Percentage of Participants With Guillain-Barre Syndrome (GBS) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)|Guillain-Barre syndrome (GBS) is a rare neurological disorder in which the body's immune system mistakenly attacks part of its peripheral nervous system—the network of nerves located outside of the brain and spinal cord. GBS can range from a very mild case with brief weakness to nearly devastating paralysis, leaving the person unable to breathe independently.|Up to 6 months post booster vaccination|All eligible participants who received primary vaccination in study 107386 [NCT00356369] and received booster dose of vaccine in study MENACWY-099.|||percentage of participants|||Number
2622943|NCT01934140|Secondary|Booster Phase: Percentage of Participants With New Onset Chronic Illness From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)|New onset chronic illness included autoimmune disorders, asthma, type I diabetes, and allergies.|Up to 6 months post booster vaccination|All eligible participants who received primary vaccination in study 107386 [NCT00356369] and received booster dose of vaccine in study MENACWY-099.|||percentage of participants|||Number
2622944|NCT01934140|Secondary|Booster Phase: Percentage of Participants With Serious Adverse Events (SAEs) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to 6 months post booster vaccination|All eligible participants who received primary vaccination in study 107386 [NCT00356369] and received booster dose of vaccine in study MENACWY-099.|||percentage of participants|||Number
2622945|NCT01934140|Secondary|Booster Phase: Percentage of Participants With Unsolicited Adverse Events (AEs) up to 31 Days Post Booster Vaccination|An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Up to 31 days post booster vaccination|All eligible participants who received primary vaccination in study 107386 [NCT00356369] and received booster dose of vaccine in study MENACWY-099.|||percentage of participants|||Number
2622946|NCT01934140|Secondary|Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination|Solicited local events:1)pain(Grade [G] : 0=none,1=mild,neither interfered nor prevented normal activities,2=moderate, painful when limb moved; interfered with normal activities,3=severe, significant pain at rest,prevented normal activities),2)redness, and 3)swelling (record greatest surface diameter in millimetre[mm] as 0 to less than or equal to[<=]20 mm, greater than[>]20 to <=50 mm,>50 mm). If to resolve any event medical advice taken, results reported as Medical Advice. Solicited general events: 1) fatigue, 2) gastrointestinal(GI) events(nausea, vomiting, diarrhea and/or abdominal pain,3) headache(G : 0=normal, 1=mild, easily tolerated,2=moderate, interfered with normal activity,3=severe, prevented normal activity), and 4)fever (G: 0=less than[<] 37.5 degree Celsius[°C], 1= 37.5 degree C to 38.0degree C, 2= 38.1 degreeC to 39.0 degree C,3 =>39.0 degree C). 'Related'=relationship to study vaccine assessed by investigator.Medical advice=medical advice received to resolve any event.|Up to 4 days post booster vaccination|All eligible participants who received primary vaccination in study 107386 [NCT00356369] and received booster dose of vaccine in study MENACWY-099. “n” participants analyzed for specified categories.|||percentage of participants|||Number
2622947|NCT01934140|Secondary|Booster Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against-Tetanus Toxoid (Anti-TT) at 1 Month After Booster Vaccination|TT was used as carrier in tetravalent meningococcal ACWY conjugate vaccine. Percentage of participants with anti-TT concentration >=0.1 IU/mL, >=1.0 IU/mL were summarized.|1 month after booster vaccination|All eligible participants who received primary vaccination in study107386 [NCT00356369], received booster dose of vaccine in study MENACWY-099; for whom assay results are available for antibodies against at least 1 study vaccine antigen component for blood sample taken 1 month after vaccination. N=participants evaluable for this measure.|||IU/mL||95% Confidence Interval|Geometric Mean
2622948|NCT01934140|Secondary|Booster Phase: Percentage of Participants With Antibodies Against-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL at 1 Month After Booster Vaccination|Tetanus toxoid (TT) was used as carrier in tetravalent meningococcal ACWY conjugate vaccine. Percentage of participants with anti-TT concentration >=0.1 IU/mL, >=1.0 IU/mL were summarized.|1 month after booster vaccination|All eligible participants who received primary vaccination in study107386 [NCT00356369], received booster dose of vaccine in study MENACWY-099; for whom assay results are available for antibodies against at least 1 study vaccine antigen component for blood sample taken 1 month after vaccination. N=participants evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2622949|NCT01934140|Secondary|Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY. rSBA booster vaccine responses for serogroups A, C, W-135 and Y defined as: for initially seronegative participants (pre-vaccination titer below the cut-off of 1:8) had rSBA antibody titers >= 1:32, 1 month after vaccination, and for initially seropositive participants (pre-vaccination titer >= 1:8) had rSBA antibody titers at least 4 times the pre-vaccination antibody titers, 1 month after vaccination. Data reported below is including both seropositive and seronegative participants.|1 month after booster vaccination|All eligible participants: received primary vaccination in study 107386[NCT00356369] and booster dose in study MENACWY-099;assay results available for antibodies against at least 1 study vaccine antigen component in blood sample taken 1 month post vaccination. N=participants evaluable for measure, n=participants analyzed for specified serogroups.|||percentage of participants||95% Confidence Interval|Number
2622950|NCT01934140|Secondary|Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.|1 month after booster vaccination|All eligible participants who received primary vaccination in study107386 [NCT00356369], received booster dose of vaccine in study MENACWY-099; for whom assay results are available for antibodies against at least 1 study vaccine antigen component for blood sample taken 1 month after vaccination. N=number of participants evaluable for this measure.|||titers||95% Confidence Interval|Geometric Mean
2622951|NCT01934140|Secondary|Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|1 month after booster vaccination|All eligible participants who received primary vaccination in study107386 [NCT00356369], received booster dose of vaccine in study MENACWY-099; for whom assay results are available for antibodies against at least 1 study vaccine antigen component for blood sample taken 1 month after vaccination. N=number of participants evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2623471|NCT01930487|Secondary|Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio)|change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
2622952|NCT01934140|Primary|Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.|After 10 years of primary vaccination|All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 [NCT00356369], had available assay results for at least 1 tested antigen. Here, “N” signifies number of participants evaluable for this measure and “n”: participants analyzed for specified serogroup.|||titers||95% Confidence Interval|Geometric Mean
2622953|NCT01934140|Primary|Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.|After 9 years of primary vaccination|All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 [NCT00356369], had available assay results for at least 1 tested antigen.Here, “N” signifies number of participants evaluable for this measure.|||titers||95% Confidence Interval|Geometric Mean
2622954|NCT01934140|Primary|Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.|After 8 years of primary vaccination|All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 [NCT00356369], had available assay results for at least 1 tested antigen. Here, “N” signifies number of participants evaluable for this measure and “n”: participants analyzed for specified serogroup.|||titers||95% Confidence Interval|Geometric Mean
2622955|NCT01934140|Primary|Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.|After 7 years of primary vaccination|All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 [NCT00356369], had available assay results for at least 1 tested antigen. Here, “N” signifies number of participants evaluable for this measure.|||titers||95% Confidence Interval|Geometric Mean
2622956|NCT01934140|Primary|Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 percentage (%) reduction of meningococcal colony-forming units.|After 6 years of primary vaccination|Data was not collected and analyzed for this outcome measure because approval was not obtained from the authorities for Year 6 activities.||||||
2622957|NCT01934140|Primary|Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|After 10 years of primary vaccination|All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 [NCT00356369], had available assay results for at least 1 tested antigen. Here, “N” signifies number of participants evaluable for this measure and “n”: participants analyzed for specified serogroup.|||percentage of participants||95% Confidence Interval|Number
2622958|NCT01934140|Primary|Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|After 9 years of primary vaccination|All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 [NCT00356369], had available assay results for at least 1 tested antigen. Here, “N” signifies number of participants evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2622959|NCT01934140|Primary|Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|After 8 years of primary vaccination|All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 [NCT00356369], had available assay results for at least 1 tested antigen. Here, “N” signifies number of participants evaluable for this measure and “Number analyzed” (n): participants analyzed for specified serogroup.|||percentage of participants||95% Confidence Interval|Number
2622960|NCT01934140|Primary|Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|After 7 years of primary vaccination|All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 [NCT00356369], had available assay results for at least 1 tested antigen. Here, “Overall Number of Participants Analyzed” (N) signifies number of participants evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2622961|NCT01934140|Primary|Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers Greater Than or Equal to (>=) 1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination|Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY).|After 6 years of primary vaccination|Data was not collected and analyzed for this outcome measure because approval was not obtained from the authorities for Year 6 activities.||||||
2622962|NCT01934010|Secondary|Frequency of Subjects With a Deterioration of Hearing Threshold at Day 252 (Air Conduction)|"Valid for Safety Analysis Set was used.~Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.~The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies."|Day 168 (TV7) to Day 252 (FUV9) of cycle 3|The safety analysis set includes all subjects that had at least one intratympanic injection. Subjects are only considered at a time point if the hearing threshold is available.|||Number subject affected|||Number
2622963|NCT01934010|Secondary|Frequency of Subjects With a Deterioration of Hearing Threshold at Day 168 (Air Conduction)|"Valid for Safety Analysis Set was used.~Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.~The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies."|Day 84 (TV4) to Day 168 (FUV6) of cycle 2|The safety analysis set includes all subjects that had at least one intratympanic injection. Subjects are only considered at a time point if the hearing threshold is available.|||Number subject affected|||Number
2622964|NCT01934010|Secondary|Frequency of Subjects With a Deterioration of Hearing Threshold at Day 84 (Air Conduction)|"Valid for Safety Analysis Set was used.~Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.~The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies."|Day 1 (TV1) to Day 84 (FUV3) of cycle 1|The safety analysis set includes all subjects that had at least one intratympanic injection. Subjects are only considered at a time point if the hearing threshold is available.|||Number subject affected|||Number
2622965|NCT01934010|Primary|Frequency of Subjects With a Deterioration of Hearing Threshold at Day 203 (Air Conduction)|"Valid for Safety Analysis Set was used.~Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.~The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies."|Day 168 (TV7) up to Day 203 (FUV8) of cycle 3||||Number subject affected|||Number
2622966|NCT01934010|Primary|Frequency of Subjects With a Deterioration of Hearing Threshold at Day 119 (Air Conduction)|"Valid for Safety Analysis Set was used.~Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.~The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies."|Day 84 (TV4) to Day 119 (FUV5) of cycle 2|"The safety analysis set includes all subjects that had at least one intratympanic injection. Subjects are only considered at a time point if the hearing threshold is available.~Subjects from Cycle 1 did not participate in Cycle 2 and 3 and are therefore zero."|||Number subject affected|||Number
2622967|NCT01934010|Primary|Frequency of Subjects With a Deterioration of Hearing Threshold at Day 35 (Air Conduction)|"Valid for Safety Analysis Set was used.~Air conduction: The atmospheric transmission of sound to the inner ear through the external auditory canal and via structures of the middle ear. The ability of hearing is measured in decibel (dB). The hearing threshold, is the lowest sound pressure where the ear can perceive still a sound.~The endpoint deterioration of hearing threshold ≥15 dB in two contiguous test frequencies means that hearing worsens ≥15 dB in two neighboring sound frequencies."|Day 1 (TV1) to Day 35 (FUV2) of cycle 1|The safety analysis set includes all subjects that had at least one intratympanic injection. Subjects are only considered at a time point if the hearing threshold is available.|||Number subject affected|||Number
2622968|NCT01933984|Secondary|Mortality Rate|The percentage of participants died at day 180.|the 180th day after enrollment||||percentage of participants|||Number
2622969|NCT01933984|Secondary|Numbers of Episode of Drug-related Adverse Effect|The numbers of episode of drug-related adverse effect. Naranjo score should be over 4 to be considered drug-related adverse effect. Naranjo score range form 0 to 9, and the higher scores means a higher relationship with drug-related adverse effect.|From day 1 to day 28 after enrollment||||episodes||Standard Deviation|Median
2622970|NCT01933984|Secondary|Number of Total Puff of Rescue Short-acting Bronchodilator|The number of total puff of rescue short-acting bronchodilator.|the 28th day after enrollment||||puffs|||Number
2622971|NCT01933984|Secondary|Number of Episode of Nosocomial Pneumonia|The number of episodes of nosocomial pneumonia happened by day 28. And nosocomial pneumonia is a lower respiratory infection that was not incubating at the time of hospital admission and that presents clinically 2 or more days after hospitalization.|the 28th day after enrollment||||episodes of nosocomial pneumonia||Standard Deviation|Median
2622972|NCT01933984|Secondary|The Participants of Breathing Without Assistance by Day 28|The number of participants who breath without ventilator by day 28|the 28th day after enrollment||||the number of participants|||Number
2622973|NCT01933984|Secondary|Ventilator-free Days From Day 1 to 28|Ventilator-free days from day 1 to 28 after enrollment|From day 1 to day 28 after enrollment||||day|||Number
2622974|NCT01933984|Primary|Rapidity of ∆Raw Change|The relative daily Raw deviation from target|Airway resistance will be recorded everyday. If a patient's ventilator was liberated less than 28 days, the day of liberation was the reported time frame. If the day of ventilator liberation was over 28 days, the 28th day was the reported time frame.||||percentage of relative Raw deviation||Standard Deviation|Mean
2622975|NCT01933984|Primary|∆Raw (the Difference Between Measured and Target Airway Resistance)|The value can be expressed as relative deviation from target =(measured Raw - target Raw)/target Raw X100|Airway resistance will be recorded everyday. If a patient's ventilator was liberated less than 28 days, the day of liberation was the reported time frame. If the day of ventilator liberation was over 28 days, the 28th day was the reported time frame.|The deviation of Raw from the personal target, which was calculated as (measured Raw−target Raw)/target Raw.|||percentage of relative Raw deviation||Standard Deviation|Mean
2623035|NCT01933789|Other Pre-specified|Group Differences - Treatment Preference (Adjustment Variable for Outcome Measuring Goal-concordant Care)|Binary variable indicating whether patient's current preference was for life-extension or comfort care|3 months after target visit|Patients completing 3-month questionnaires.|||Participants|||Count of Participants
2623571|NCT01929460|Primary|Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration|third and final time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)|At 6 weeks after procedure||||participants|||Number
2622976|NCT01933932|Secondary|Time to Symptom Progression Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)|Time to symptom progression will be defined as the time from randomization until the date of first clinically meaningful symptom deterioration (defined as an increase in the ASBI from baseline ≥10), or death (by any cause). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.|Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)|Full analysis set (FAS) patients who have a baseline ASBI score <= 90|||Months||Inter-Quartile Range|Median
2622977|NCT01933932|Secondary|Symptom Improvement Rate Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)|The symptom improvement rate will be defined as the number (%) of patients with two consecutive assessments at least 18 days apart (ie 21 days allowing a visit window of 3 days) which showed a clinically meaningful improvement in symptoms from baseline (defined as a decrease in the ASBI from baseline ≥10). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.|Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)|Full analysis set (FAS) patients who have a baseline ASBI score >= 10|||Number of patients with improvements|||Number
2622978|NCT01933932|Secondary|Duration of Response (DoR)|Duration of response is defined as the time from the date of first documented response until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)|Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)|Full analysis set (FAS) population comprised of all randomised patients.|||Days||95% Confidence Interval|Median
2622979|NCT01933932|Secondary|Objective Response Rate (ORR)|ORR is defined as the number (%) of subjects with at least one overall visit response of complete response (CR) or partial response (PR). Per RECIST v1.1 for target lesions and assessed by CT/MRI: CR - disappearance of all target lesions; PR - >=30% decrease in the sum of the longest diameter of target lesion. (Non-target lesion and new lesion results are also taken into account for the overall visit result)|Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)|Full analysis set (FAS) population comprised of all randomised patients.|||Number of responders|||Number
2622980|NCT01933932|Secondary|Overall Survival (OS)|Overall Survival is defined as the time from the date of randomisation until death due to any cause.|Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI|Full analysis set (FAS) population comprised of all randomised patients.|||Months||Inter-Quartile Range|Median
2622981|NCT01933932|Primary|Progression-Free Survival (PFS)|Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)|Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)|Full analysis set (FAS) population comprised of all randomised patients.|||Months||Inter-Quartile Range|Median
2622982|NCT01933919|Secondary|Number of Participants With Adverse Events During the Second Phase|"An adverse event was assessed as treatment-related by the investigator if there was evidence to suggest a causal relationship between the study drug and the adverse event.~The investigator used the following definitions to rate the severity of each adverse event:~Mild: The adverse event was transient and easily tolerated by the participant;~Moderate: The adverse event caused the participant discomfort and interrupted usual activities.~Severe: The adverse event caused considerable interference with the participant's usual activities and may have been incapacitating or life-threatening.~A serious adverse event was any event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, or was an important medical event requiring medical or surgical intervention to prevent a serious outcome."|From the first dose of the study drug up to 30 days after the last dose of the study drug, approximately 60 weeks in the second phase of the study.|Participants who received the study drug at least once in the second phase.|||participants|||Number
2622983|NCT01933919|Secondary|Number of Participants With Adverse Events During the First Phase|"An adverse event (AE) was assessed as treatment-related by the investigator if there was evidence to suggest a causal relationship between the study drug and the adverse event.~The investigator used the following definitions to rate the severity of each adverse event:~Mild: The adverse event was transient and easily tolerated by the participant;~Moderate: The adverse event caused the participant discomfort and interrupted usual activities.~Severe: The adverse event caused considerable interference with the participant's usual activities and may have been incapacitating or life-threatening.~A serious adverse event was any event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, or was an important medical event requiring medical or surgical intervention to prevent a serious outcome."|From the first dose of the study drug up to 30 days after the last dose of the study drug, approximately 18 weeks in the first phase.|Participants who received the study drug at least once in the first phase|||participants|||Number
2622984|NCT01933919|Secondary|Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase|"The investigator evaluated Clinical Global Impression (CGI) to rate participants' clinical symptomatology according to the following seven categories at each visit compared to the day of the first dose of study medication in the 2nd phase:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Worse~Very much worse~Much improved includes CGI score categories 'very much improved' and 'much improved'."|Baseline of the 2nd phase and weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Full analysis set for the 2nd phase; last observation carried forward imputation was used for the last post-baseline visit assessment.|||percentage of participants|||Number
2623036|NCT01933789|Secondary|Palliative Care Consultation, Inpatient Stay - All Patients|EHR documentation of palliative care consultation during an inpatient stay for all patients with target visit and chart abstraction.|3-month period following the target visit|Patients who had a target visit and a chart reviewed.|||Participants|||Count of Participants
2622985|NCT01933919|Secondary|Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase|"The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.~Baseline for the 2nd phase was the first visit of the 2nd phase after completion of the tapering period in the first phase and prior to study drug administration in the 2nd phase."|Baseline of the 2nd phase and weeks 2, 8, 16, 28, 40, and 52 of the 2nd phase|The full analysis set (FAS) for the 2nd phase (FAS2) included participants who received at least one dose of study drug, and had a baseline and at last one post-baseline measurement for efficacy after week 1 in the 2nd phase. Last observation carried forward imputation was used for the last post-baseline visit assessment.|||units on a scale||Standard Deviation|Mean
2622986|NCT01933919|Secondary|Percentage of Participants With a ≥ 35% Decrease From Baseline in JCY-BOCS (10-item) Total Score at the End of Treatment in the First Phase|The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions were rated on a scale from 0 (none) to 4 (extreme). The total score was calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.|Baseline and week 10|Full analysis set for the first phase; last observation carried forward imputation was used.|||percentage of participants|||Number
2622987|NCT01933919|Secondary|Percentage of Participants With a ≥ 25% Decrease From Baseline in JCY-BOCS (10-item) Total Score at the End of Treatment in the First Phase|The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions were rated on a scale from 0 (none) to 4 (extreme). The total score was calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.|Baseline and week 10|Full analysis set for the first phase; last observation carried forward imputation was used.|||percentage of participants|||Number
2622988|NCT01933919|Secondary|Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase|"The investigator evaluated Clinical Global Impression (CGI) to rate participants' clinical symptomatology according to the following seven categories at each visit compared to the day of the first dose of study medication:~Very much improved~Much improved~Minimally improved~No change~Minimally worse~Worse~Very much worse~Much improved includes CGI score categories 'very much improved' and 'much improved'."|Weeks 1, 2, 3, 4, 5, 6, 8, and 10|Full analysis set for the first phase; participants with available data at each time point. Last observation carried forward imputation was used for the last post-baseline visit assessment.|||percentage of participants|||Number
2622989|NCT01933919|Secondary|JCY-BOCS 10-item Total Score at Each Visit During the First Phase|The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.|Baseline and weeks 2, 4, 6, 8 and 10|Full analysis set for the first phase; participants with available data at each time point. Last observation carried forward imputation was used for the last post-baseline visit assessment.|||units on a scale||Standard Deviation|Mean
2622990|NCT01933919|Secondary|Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase|The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.|Baseline and weeks 2, 4, 6, 8 and 10|Full analysis set for the 1st phase; participants with available data at each time point.|||units on a scale||Standard Deviation|Mean
2622991|NCT01933919|Secondary|Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Gender|The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.|Baseline and week 10|Full analysis set for the 1st phase; last observation carried forward imputation was used.|||units on a scale||Standard Deviation|Mean
2622992|NCT01933919|Secondary|Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Age|The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.|Baseline and week 10|Full analysis set for the first phase; last observation carried forward imputation was used.|||units on a scale||Standard Deviation|Mean
2622993|NCT01933919|Primary|Mean Change From Baseline in the Japanese Children's Yale-Brown Obsessive Compulsive Scale 10-item Total Score at the End of Treatment in the First Phase|The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of obsessive compulsive disorder (OCD) in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.|Baseline and week 10|Full analysis set for the 1st phase; last observation carried forward imputation was used.|||units on a scale||Standard Deviation|Mean
2623037|NCT01933789|Secondary|Avoidance of Life-Sustaining Therapies, Patients With Comfort Care Preference|"Review of EHR documentation to assess use of three indicators of life-sustaining therapies (LST): admission to an ICU, receipt of CPR, and receipt of mechanical ventilation for patients preferring comfort (quality of life over extending life) at the end-of-life"|6-month period following the target visit|Patients who had a target visit and a chart reviewed.|||Participants|||Count of Participants
2622994|NCT01933880|Secondary|Number of Participants Compliant With Treatment|Number of Participants who are Compliant with Treatment will be accessed. Less than 80 percent and more than 120 percent compliance signifies bad compliance, 80 to 120 percent compliance signifies good compliance . The compliance was calculated by the percentage of dose (actual dose multiplied by 100/theoretical dose).The theoretical dose means the dose prescribed by the Investigator.|End of Week 12|"FAS population for OROS-MPH Group. Here N signifies participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."|||participants|||Number
2622995|NCT01933880|Secondary|Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale at Week 12|Remission rate in different dosage groups will be accessed to evaluate the relationship between therapeutic effect and dosage. Remission rate is the percentage of participants with total score of IO sub-scale less than or equal to 5 in IOWA Conners measurement scale.|Week 12|"FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Here N signifies participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
2622996|NCT01933880|Secondary|Change From Baseline in Completion Time of Stroop Color-word Test at Week 12|Completion time of stroop color-word test in different dosage groups will be accessed to evaluate the relationship between therapeutic effect and dosage. This is a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A participant will be given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test will be scored on the number of correct answers. There are 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list. Median time of the naming time in the Stroop color word naming test will be accessed. Stroop color word naming test 1 ,2 ,3 and 4 stand for gradually increased difficulty and each test has a corresponding baseline and endpoint.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Here N signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable at each time point for each specific arm."|||Seconds||Standard Deviation|Mean
2622997|NCT01933880|Secondary|Change From Baseline in Total Scores of Digit Span Test at Week 12|The digit span test total score will be accessed in different dosage groups to evaluate the relationship between therapeutic effect and dosage. The digit span test is mainly used to measure the ability of short-term memory and attention. The participant will be given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score is the number of correct responses, where the digits were repeated correctly. One point will be given for each correctly repeated string of digits. The maximum subscore in the Digits Forward is16, and the maximum subscore in the Digits Backward is 14, for a total score of 30. A higher score was indicative of better recall and attention.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Here N signifies participants who were evaluable for this outcome measure."|||Scores on a scale||Standard Deviation|Mean
2622998|NCT01933880|Secondary|Change From Baseline in I/O Score of IOWA Conners Behavior Rating Scale at Week 12|IOWA conners behavior rating scale score in different dosage groups will be accessed to evaluate relationship between therapeutic effect and dosage. IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Here N signifies participants who were evaluable for this outcome measure."|||Scores on a scale||Standard Deviation|Mean
2622999|NCT01933880|Secondary|Number of Participants With Clinical Global Impression - CGI Scale Score|CGI is an overall rating scale. Clinical Global Impression (Improvement of Diseases) is divided into seven grades: 1=very significant improvement, 24=significant improvement or advanced, 3=improvement or slightly advanced, 4=no change, 5=slight aggravation, 6=significant aggravation, and 7=very significant aggravation or seriously aggravated. Number of participants in each category of grade were assessed.|End of Week 1, 2, 3, 7 and 12|FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test|||Participants|||Number
2623000|NCT01933880|Secondary|Academic Achievement|Mathematics and language scores will be obtained from their corresponding examinations at school. Scores ranges from 0-100 respectively. Mathematics and language would be summarized separately.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||scores on a scale||Standard Deviation|Mean
2623001|NCT01933880|Secondary|Coding Test|The coding Test is a common test indicator for perceptual speed. The test presents a series of corresponding relationship between graphics and symbols to the participant, and then participants will be required to fill out the appropriate symbol following single symbol in the test part. The test is limited within 150 seconds and evaluated the number of symbols been replaced correctly by the participants.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||Number of symbols correctly replaced||Standard Deviation|Mean
2623002|NCT01933880|Secondary|WCST: Learning to Learn (L-C)|"WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. Learning to learn indicator was a measure of decrement in the number of responses needed to achieve each successive category. The raw score ranged from 0 to 100. The high, negative value suggests the participants could not effectively learn the task presented by the WCST. Only calculated in those completed 3 or more categories and not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case)."|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||number of responses||Standard Deviation|Mean
2623003|NCT01933880|Secondary|WCST: Failure to Maintain Set (Fm)|WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. The frequency (number of times) of responses completed with 5 to 9 continuous correct was evaluated. Ranges from 0 to 26 and was not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case).|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||number of times||Standard Deviation|Mean
2623004|NCT01933880|Secondary|WCST: Non-Persistent Error Responses (nRpe)|WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Non perseverative error responses are the errors remaining after subtracting persistent errors from total errors. Ranges from 0 to 128 and was not linear (cannot be considered to be good or bad just judged by the number, analyzed with other factors case by case).|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||number of non-persistent error responses||Standard Deviation|Mean
2623005|NCT01933880|Secondary|WCST: Percentage of Perseverative Error Responses (Rpe%)|WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative (pvt) errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of persistent errors out of total number of responses was evaluated. Ranges from 0 to 100%, the less the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||Percentage of pvt error responses||Standard Deviation|Mean
2623006|NCT01933880|Secondary|WCST: Perseverative Error Responses (Rpe)|WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Perseverative error responses are the number of responses which applied continuity principle for matching answers and also had the wrong answer was evaluated. Ranges from 0 to 128, the less the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||number of perseverative error responses||Standard Deviation|Mean
2623018|NCT01933880|Primary|Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 7|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 7|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."|||Scores on a scale||Standard Deviation|Mean
2623007|NCT01933880|Secondary|WCST: Perseverative Responses (Rp)|WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of perseverative responses were the responses which applied continuity principle for matching answers was evaluated. Ranges from 0 to 100, the less the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||number of perseverative responses||Standard Deviation|Mean
2623008|NCT01933880|Secondary|WCST: Percentage of Conceptual Level Responses (Rf%)|WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of the responses completed with 3-10 continuous correct during the entire measuring process was evaluated. Ranges from 0 to 100%, the more the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||percentage of conceptual level responses||Standard Deviation|Mean
2623009|NCT01933880|Secondary|WCST: First Response (Rf)|WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of responses needed to complete the first color classification was evaluated. Ranges from 9 to 128, the lesser the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||number of first responses||Standard Deviation|Mean
2623010|NCT01933880|Secondary|WCST: Percentage of Correct Responses (Rc%)|WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Percentage of correct responses which meets all the requirements according to the response principles was evaluated. Ranges from 0 to 100 percent (%), the more the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||Percentage of correct responses||Standard Deviation|Mean
2623011|NCT01933880|Secondary|WCST: Error Responses (Re)|WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. Number of error responses which did not comply with the response principles was evaluated. Ranges from 0 to 128, the less the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||number of error responses||Standard Deviation|Mean
2623019|NCT01933880|Primary|Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 3|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 3|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."|||Scores on a scale||Standard Deviation|Mean
2625898|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||mg/dL||Standard Deviation|Mean
2623012|NCT01933880|Secondary|WCST: Correct Responses (Rc)|WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. The number of correct responses which meets all the requirements according to the response principles was evaluated. Ranges from 0-116, the more the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||number of correct responses||Standard Deviation|Mean
2623013|NCT01933880|Secondary|WCST: Completed Categories (Cc)|WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. In completed categoriies, number of categories completed out of 6 sorting categories after the test was evaluated. Ranges from 0 to 6. The more the number of categories completed the better is the response.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||Nunber of Categories Completed||Standard Deviation|Mean
2623014|NCT01933880|Secondary|Wisconsin Card Sorting Test (WCST): Administered Responses (Ra) of Completed Examination|WCST is used to evaluate participants' abilities of abstract generalization, working memory, and distraction-cognitive clinically, which reflects participants' cognitive function objectively and comprehensively. WCST consists of 13 test indicators and all indicators will be analyzed separately. The 13 indicators are as follows: number of trials administered; number of categories completed; response corrects; percent corrects; total number of errors; trials to complete first category; percent conceptual level responses; perseverative responses; perseverative errors; percent perseverative errors; nonperseverative errors; failure to maintain set; learning to learn. During number of trials administered or administered responses, participants were administered 128 cards and asked to sort the cards until all the 6 sorting categories was completed. Response number used to complete all 6 categories ranges from 50 to 128, lesser the better.|Baseline and End of Week 12|"FAS population for OROS-MPH Group included participants who received at least 1 study drug and had at least one efficacy evaluation. FAS for normal group included all participants who had baseline scale evaluation and had at least one endpoint scale evaluation. n signifies participants who were evaluable at each time point for each specific arm."|||Responses||Standard Deviation|Mean
2623015|NCT01933880|Secondary|Stroop Color Word Naming Test|This is a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A participant will be given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test is scored on the number of correct answers. There are 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list. Median naming time in the Stroop color word naming test will be assessed. Stroop color word naming test 1 ,2 ,3 and 4 stand for gradually increased difficulty and each test has a corresponding baseline and endpoint.|Baseline and End of Week 12|FAS for OROS-MPH Group included participants who took at least 1 study drug therapy and had at least 1 efficacy evaluation. FAS for normal group included participants who had baseline assessment scale evaluation and had at least 1 endpoint assessment scale evaluation. ‘n’=participants who were evaluable at each specific time point for each arm.|||Seconds||Standard Deviation|Mean
2623016|NCT01933880|Secondary|Percentage of Participants With Total Score of IO Sub-scale Less Than or Equal to 5 in IOWA Conners Measurement Scale.|Remission rate is the percentage of participants with total score of IO sub-scale less than or equal to 5 in IOWA Conners measurement scale|End of Week 1, 2, 3, 7 and 12|FAS population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test.|||Percentage of Participants|||Number
2623017|NCT01933880|Primary|Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 12|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 12|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."|||Scores on a scale||Standard Deviation|Mean
2623033|NCT01933789|Secondary|Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit|"EHR documentation of palliative care consultation during an inpatient stay for patients who reported preference for comfort care (quality of life over extending life) and wanted a discussion."|3-month period following the target visit|Patients who had a target visit and a chart reviewed.|||Participants|||Count of Participants
2623572|NCT01929460|Primary|Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration|second time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)|At 4 weeks after procedure||||participants|||Number
2623020|NCT01933880|Primary|Change From Baseline in IOWA Conners Behavior Rating Scale - I/O Score at Week 2|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 2|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."|||Scores on a scale||Standard Deviation|Mean
2623021|NCT01933880|Primary|Change From Baseline in Inattention/Overactivity With Aggression (IOWA) Conners Behavior Rating Scale - I/O Score at Week 1|IOWA Conners Behavior Rating Scale evaluated by parents provides accurate measurement standards for behavioral change and therapeutic response. It includes 2 sub-scales: Inattention/Overactivity (I/O) subscale and Attacks (A), also known as Opposition/Defiant (O/D) sub-scale. IO (primary measurement ) will be assessed using 5-items and all Items will be scored on a 4-point scale (from 0=not at all to 3=very much). Total score range is from 0 to 15. Higher scores indicate worsening.|Baseline and Week 1|"FAS population for OROS-MPH Group. Here N signifies number of participants who were evaluable for this outcome measure. Data for Normal group was not analyzed for IOWA Conners scale since as per the planned analysis normal participants were only analyzed for the memory effect in cognitive function test."|||Scores on a scale||Standard Deviation|Mean
2623022|NCT01933880|Primary|Change From Baseline in Digit Span Test Total Score at Week 12|The digit span test is mainly used to measure the ability of short-term memory and attention. The participant will be given a string of digits and asked to repeat them forward, and then a second string of digits to repeat backward. The score is the number of correct responses, where the digits were repeated correctly. One point will be given for each correctly repeated string of digits. The maximum subscore in the Digits Forward is 16, and the maximum subscore in the Digits Backward is 14, summed for a total score of 30. A higher score is indicative of better recall and attention.|Baseline and Week 12|Full Analysis Set (FAS) population for OROS-MPH Group included all participants who received at least one study drug therapy and had at least one efficacy evaluation. FAS for normal group included all participants who received baseline assessment scale evaluation and had at least one endpoint assessment scale evaluation.|||Scores on a scale||Standard Deviation|Mean
2623023|NCT01933789|Secondary|Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit|"EHR documentation of palliative care referral during an outpatient visit and/or palliative care consultation during an inpatient stay for patients who reported preference for comfort care (quality of life over extending life) and wanted a discussion."|6-month period following the target visit|Patients who had a target visit and a chart reviewed.|||Participants|||Count of Participants
2623024|NCT01933789|Secondary|Palliative Care Consultation and/or Referral - All Patients|EHR documentation of palliative care referral during an outpatient visit and/or palliative care consultation during an inpatient stay.|6-month period following the target visit|Patients who had a target visit and a chart reviewed.|||Participants|||Count of Participants
2623025|NCT01933789|Secondary|Palliative Care Consultation and/or Referral - Patients Most Likely to Benefit|"EHR documentation of palliative care referral during an outpatient visit and/or palliative care consultation during an inpatient stay for patients who reported preference for comfort care (quality of life over extending life) and wanted a discussion."|3-month period following the target visit|Patients who had a target visit and a chart reviewed.|||Participants|||Count of Participants
2623026|NCT01933789|Secondary|Palliative Care Consultation and/or Referral - All Patients|EHR documentation of palliative care referral during an outpatient visit and/or palliative care consultation during an inpatient stay.|3-month period following the target visit|Patients who had a target visit and a chart reviewed.|||Participants|||Count of Participants
2623027|NCT01933789|Secondary|Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit|"EHR documentation of referral to palliative care services, or discussion about a referral, during an outpatient visit for patients who reported preference for comfort care (quality of life over extending life) and wanted a discussion."|6-month period following the target visit|Patients who had a target visit and a chart reviewed.|||Participants|||Count of Participants
2623028|NCT01933789|Secondary|Palliative Care Referral, Outpatient Visit - All Patients|EHR documentation of referral to palliative care services, or discussion about a referral, during an outpatient visit.|6-month period following the target visit|Patients who had a target visit and a chart reviewed.|||Participants|||Count of Participants
2623029|NCT01933789|Secondary|Palliative Care Referral, Outpatient Visit - Patients Most Likely to Benefit|"EHR documentation of referral to palliative care services, or discussion about a referral, during an outpatient visit for patients who reported preference for comfort care (quality of life over extending life) and wanted a discussion."|3-month period following the target visit|Patients who had a target visit and a chart reviewed.|||Participants|||Count of Participants
2623030|NCT01933789|Secondary|Palliative Care Referral, Outpatient Visit - All Patients|EHR documentation of referral to palliative care services, or discussion about a referral, during an outpatient visit.|3-month period following the target visit|Patients who had a target visit and a chart reviewed.|||Participants|||Count of Participants
2623031|NCT01933789|Secondary|Palliative Care Consultation, Inpatient Stay - Patients Most Likely to Benefit|"EHR documentation of palliative care consultation during an inpatient stay for patients who reported preference for comfort care (quality of life over extending life) and wanted a discussion."|6-month period following the target visit|Patients who had a target visit and a chart reviewed.|||Participants|||Count of Participants
2623032|NCT01933789|Secondary|Palliative Care Consultation, Inpatient Stay - All Patients|EHR documentation of palliative care consultation during an inpatient stay for all patients with target visit and chart abstraction.|6-month period following the target visit|Patients who had a target visit and a chart reviewed.|||Participants|||Count of Participants
2623038|NCT01933789|Secondary|Avoidance of Life-Sustaining Therapies, All Patients|Review of EHR documentation to assess use of three indicators of life-sustaining therapies (LST): admission to an ICU, receipt of CPR, and receipt of mechanical ventilation|6-month period following the target visit|Patients who had a target visit and a chart reviewed.|||Participants|||Count of Participants
2623039|NCT01933789|Secondary|Generalized Anxiety Disorder (GAD-7): Seven-Item Scale|"Generalized Anxiety Disorder: A self-report measure of anxiety symptoms. Seven symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'.~Seven-Item Scale: Sum of responses for the seven symptoms (weighted by 7/6 if only 6 items answered). (Strong floor effect.)~Theoretical range: 0-21 Actual range: 0-21 Higher value indicates worse outcome (i.e., higher level of anxiety symptoms) Unit of measurement: scores on a scale"|6 months after target visit|Survey items asked of patients at 6-months. Some intervention and control patients did not provide valid responses on 6+ items.|||scores on a scale||Inter-Quartile Range|Median
2623040|NCT01933789|Secondary|Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct|"Generalized Anxiety Disorder: A self-report measure of anxiety symptoms. Seven symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'.~Two-Indicator Latent Construct: Measured with GAD items 1 & 2 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable.~Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable Higher value indicates worse outcome (i.e., higher level of anxiety symptoms) Unit of measurement: scores on a scale"|6 months after target visit|"Both survey items answered by patients at baseline, 3-months & 6-months: 127 valid intervention responses; 150 valid control responses.~Continuous measure with control group mean fixed at zero at baseline."|||scores on a scale||Standard Deviation|Mean
2623041|NCT01933789|Secondary|Generalized Anxiety Disorder (GAD-7): Seven-Item Scale|"Generalized Anxiety Disorder: A self-report measure of anxiety symptoms. Seven symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'.~Seven-Item Scale: Sum of responses for the seven symptoms (weighted by 7/6 if only 6 items answered). (Strong floor effect.)~Theoretical range: 0-21 Actual range: 0-21 Higher value indicates worse outcome (i.e., higher level of anxiety symptoms) Unit of measurement: scores on a scale"|3 months after target visit|Survey items asked of patients at 3-months. Some intervention and control patients did not provide valid responses on 6+ items.|||scores on a scale||Inter-Quartile Range|Median
2623042|NCT01933789|Secondary|Generalized Anxiety Disorder (GAD-7): Two-Indicator Latent Construct|"Generalized Anxiety Disorder: A self-report measure of anxiety symptoms. Seven symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'.~Two-Indicator Latent Construct: Measured with GAD items 1 & 2 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable.~Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable Higher value indicates worse outcome (i.e., higher level of anxiety symptoms) Unit of measurement: scores on a scale"|3 months after target visit|"Both survey items answered by patients at baseline, 3-months & 6-months: 127 valid intervention responses; 150 valid control responses.~Continuous measure with control group mean fixed at zero at baseline."|||scores on a scale||Standard Deviation|Mean
2623043|NCT01933789|Secondary|Patient Health Questionnaire (PHQ-8): Eight-Item Scale|"Patient Health Questionnaire: A self-report measure of depressive symptoms. Eight symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'.~Eight-Item Scale: Sum of responses for the eight symptoms (weighted by 8/7 if only 7 items answered).~Theoretical range: 0-24 Actual range: 0-24 Higher value indicates worse outcome (i.e., higher level of depressive symptoms) Unit of measurement: scores on a scale"|6 months after target visit|Survey items asked of patients at 6-months. Some intervention and control patients did not provide valid responses on 7+ items.|||scores on a scale||Standard Deviation|Mean
2623044|NCT01933789|Secondary|Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct|"Patient Health Questionnaire: A self-report measure of depressive symptoms. Eight symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'.~Two-Indicator Latent Construct: Measured with PHQ items 1 & 2 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable.~Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable Higher value indicates worse outcome (i.e., higher level of depressive symptoms) Unit of measurement: scores on a scale"|6 months after target visit|"Both survey items answered by patients at baseline, 3-months & 6-months: 117 valid intervention responses; 145 valid control responses.~Continuous measure with control group mean fixed at zero at baseline."|||scores on a scale||Standard Deviation|Mean
2623045|NCT01933789|Secondary|Patient Health Questionnaire (PHQ-8): Eight-Item Scale|"Patient Health Questionnaire: A self-report measure of depressive symptoms. Eight symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'.~Eight-Item Scale: Sum of responses for the eight symptoms (weighted by 8/7 if only 7 items answered).~Theoretical range: 0-24 Actual range: 0-24 Higher value indicates worse outcome (i.e., higher level of depressive symptoms) Unit of measurement: scores on a scale"|3 months after target visit|Survey items asked of patients at baseline. Some intervention and control patients did not provide valid responses on 7+ items.|||scores on a scale||Standard Deviation|Mean
2623057|NCT01933672|Secondary|Plasma PF-04937319 Time for Cmax (Tmax) on Day 14|Tmax was time of maximum concentration. The PK parameters were summarized descriptively by treatment as appropriate.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.|||hour||Full Range|Median
2623046|NCT01933789|Secondary|Patient Health Questionnaire (PHQ-8): Two-Indicator Latent Construct|"Patient Health Questionnaire: A self-report measure of depressive symptoms. Eight symptoms, each with ordinal response options, each option associated with a text description ranging from 'Not at all' to 'Nearly every day'.~Two-Indicator Latent Construct: Measured with PHQ items 1 & 2 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable.~Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable Higher value indicates worse outcome (i.e., higher level of depressive symptoms) Unit of measurement: scores on a scale"|3 months after target visit|"Both survey items answered by patients at baseline, 3-months & 6-months: 117 valid intervention responses; 145 valid control responses.~Continuous measure with control group mean fixed at zero."|||scores on a scale||Standard Deviation|Mean
2623047|NCT01933789|Secondary|Quality of Communication (QOC): Individual QOC Items|"Quality of Communication: patient ratings of clinician on seven aspects of end-of-life communication, each aspect having a pseudo-continuous response range of 0 ('clinician didn't do this') to 11 ('the very best I could imagine').~Individual QOC Items.~Theoretical range: 0-11 Actual range: 0-11 Higher value indicates better outcome (i.e., higher quality communication) Unit of measurement: units on a scale"|2 weeks from target visit|Survey items asked of patients at 2-weeks. Not all patients provided data at this time point.|||units on a scale||Inter-Quartile Range|Median
2623048|NCT01933789|Secondary|Quality of Communication (QOC): Four-Indicator Latent Construct|"Quality of Communication: patient ratings of clinician on seven aspects of end-of-life communication, each aspect having a pseudo-continuous response range of 0 ('clinician didn't do this') to 11 ('the very best I could imagine').~Measured with QOC items 1, 2, 5, & 6 (measurement invariance imposed between groups and over time). Outcome is a latent variable, which is not observable, nor is it a composite score that can be mathematically computed (e.g., as a sum or average) from its measured indicators. Instead, it is an abstract construct that is inferred through a mathematical model; it represents a concept and is, therefore, a hypothetical variable.~Theoretical range: unknown; the latent variable is a hypothetical - not an actual - variable Actual range: inapplicable; cannot be determined; this is an indirectly-measured latent variable; Higher value indicates better outcome (i.e., higher quality communication) Unit of measurement: scores on a scale"|2 weeks from target visit|"All 4 items asked of patients at baseline & 2 weeks. Not all patients provided data at these time points.~Continuous measure with control group mean fixed at zero at baseline."|||scores on a scale||Standard Deviation|Mean
2623049|NCT01933789|Secondary|Goal-Concordant Care Among Patients With Stable Treatment Preference|Binary variable indicating whether patient's reported focus of current treatment was concordant with treatment preference|3 months after target visit|Survey items asked of patients at 3-months. Not all patients provided data at this time point.|||Participants|||Count of Participants
2623050|NCT01933789|Secondary|Goal-Concordant Care|Binary variable indicating whether patient's reported focus of current treatment was concordant with treatment preference|3 months after target visit|Survey items asked of patients at 3-months. Not all patients provided data at this time point.|||Participants|||Count of Participants
2623051|NCT01933789|Secondary|Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline|Electronic Health Record (EHR) documentation of discussion about advance care planning, prognosis, treatment preference, hospice, palliative care, or Physician Orders for Life-Sustaining Treatment (POLST) at target visit|Target visit|Patient EHR abstracted for target visit and had no objection at baseline.|||Participants|||Count of Participants
2623052|NCT01933789|Secondary|Occurrence of Discussion About Goals of Care at Target Visit Among Patients Who Did Not Object to Future Discussion at Baseline|"Patient's response to question, Did you discuss with this doctor the kind of medical care you would want if you were too sick to speak for yourself?"|2 weeks after target visit|Patients who completed 2-week questionnaires and reported no objection at baseline.|||Participants|||Count of Participants
2623053|NCT01933789|Secondary|Occurrence of Discussion About Goals of Care at Target Visit|Electronic Health Record (EHR) documentation of discussion about advance care planning, prognosis, treatment preference, hospice, palliative care, or Physician Orders for Life-Sustaining Treatment (POLST) at target visit|Target visit|Target visit abstracted from patient electronic health record (EHR); not all data were available for this time point.|||Participants|||Count of Participants
2623054|NCT01933789|Primary|Occurrence of Discussion About Goals of Care at Target Visit|"Patient's response to question, Did you discuss with this doctor the kind of medical care you would want if you were too sick to speak for yourself?"|2 weeks after target visit|Patients completing 2-week questionnaires. Not all patients provided data at this time point.|||Participants|||Count of Participants
2623055|NCT01933776|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following a Single Booster Dose of Adacel™ Vaccine|"Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.~China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling >30 mm; Fever (temperature) >39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
2623056|NCT01933776|Primary|Number of Participants Reporting Serious Adverse Events and Grade 3 Adverse Reactions Following a Single Booster Dose of Adacel™ Vaccine|"Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.~China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling >30 mm; Fever (temperature) >39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity."|Day 0 up to Day 28 post-vaccination|Serious adverse events and solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
2623058|NCT01933672|Secondary|Plasma PF-04937319 Lowest Observed Concentration During the 24-hour Period (Cmin) on Day 14|Cmin lowest observed concentration during the 24-hour period. The PK parameters were summarized descriptively by treatment as appropriate.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2623059|NCT01933672|Secondary|Plasma PF-04937319 Highest Observed Concentration (Cmax) on Day 14|Cmax was highest observed concentration. The PK parameters were summarized descriptively by treatment as appropriate.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2623060|NCT01933672|Secondary|Plasma PF-04937319 Average Concentration Over the 24-hour Period (Cav) on Day 14|Cav was average concentration over the 24-hour period. The PK parameters were summarized descriptively by treatment as appropriate.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2623061|NCT01933672|Secondary|Plasma PF-04937319 Apparent Clearance (CL/F) on Day 14|The PK parameters were summarized descriptively by treatment as appropriate. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2623062|NCT01933672|Secondary|Plasma PF-04937319 Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC24) of PF-04937319 at Day 14|The PK parameters were summarized descriptively by treatment as appropriate. Two (2) PK parameters specified in the protocol and SAP were not reported: AUClast was not reported since it was the same as AUC24 in this study, and apparent volume of distribution (Vz/F) was not reported since the log-linear terminal phase of the concentration-time profiles was not consistently well characterized in the 24-hour sampling period.|Predose, 1.5, 3, 5, 6.5, 8, 11, 12.5, and 14 hours on Days 0 and 14; and predose on Days 7 and 15.|The PK population was defined as all randomized participants who received at least 1 dose of PF 04937319 and who had at least 1 PK sample with reported concentration.|||ng•hr/mL||Geometric Coefficient of Variation|Geometric Mean
2623063|NCT01933672|Secondary|Number of Participants With Post-baseline Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern|ECG criteria of potential clinical concern were 1), PR interval: >=300 milliseconds (msec); >=25% increase when baseline >200 msec; or increase >=50% when baseline <=200 msec; 2), QRS interval: >=140 msec; >=50% increase from baseline; 3), QTc interval using Fridericia's formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >500 msec; absolute change 30 - <60, >=60 msec.|Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment.|||participants|||Number
2623064|NCT01933672|Secondary|Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern|Vital signs included blood pressure (BP; supine, sitting and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: sitting systolic BP (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from baseline, sitting SBP =<20 mmHg change from baseline, supine/sitting/standing SBP less than (<) 90 mm Hg; sitting diastolic BP (DBP) >=20 mm Hg change from baseline, sitting SBP =<20 mmHg change from baseline, supine/sitting/standing DBP <50 mm Hg; 2), pulse rate (supine): <40 or greater than (>) 120 beats per minute (bpm).|Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment.|||participants|||Number
2623065|NCT01933672|Secondary|Change From Baseline in Body Weight (kg)||Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment.|||kg||Standard Error|Mean
2623066|NCT01933672|Secondary|Frequency of Laboratory Test Abnormalities Reported in Any Treatment Group|The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed.|Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment.|||participants|||Number
2623067|NCT01933672|Secondary|Incidence of All Causality Treatment-Emergent Adverse Event by Preferred Term (Frequency Rate >5%)||Day 1 up to Day 14|The safety analysis set was all participants who received at least one dose of randomized study treatment. HAEs meeting protocol definition were summarized descriptively by treatment.|||participants|||Number
2623068|NCT01933672|Secondary|Change From Baseline in Pre-meal Insulin on Day 14|Blood samples for measurement of glucose to permit derivation of pre-meal collections of blood samples for insulin at 0, 5 and 11 hours on Day 0 (baseline) and Day 14.|Day 14|Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement on Day 14.|||micro international unit/milliliter||Standard Error|Least Squares Mean
2623069|NCT01933672|Secondary|Change From Baseline in Pre-meal C-Peptide on Day 14|Blood samples for measurement of glucose to permit derivation of pre-meal collections of blood samples for C-peptide at the pre-specified nominal timepoints at predose, 5 and 11 hours on Day 0 (baseline) and Day 14.|Day 14|Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement on Day 14.|||nanograms/milliliter (ng/mL)||Standard Error|Least Squares Mean
2623135|NCT01933048|Primary|Post-vaccination Geometric Mean Titer (GMT) Ratios Between HCWA and SA Subjects||28+/- 7 days post-vaccination||||titer ratio||95% Confidence Interval|Geometric Mean
2623070|NCT01933672|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14|"Blood samples for measurement of glucose to permit derivation of pre-meal collections at the pre-specified nominal timepoints of each period: predose (ie, time 0), 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16 and 20 hours on Day 0 (baseline) and Day 14; and predose on Days 1 and 15."|Day 14|Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement on Day 14.|||mg/dL||Standard Error|Least Squares Mean
2623071|NCT01933672|Primary|Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 14|Plasma glucose concentration was determined predose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours postdose on Days 0 (baseline) and 14. WMDG was calculated as the area under the curve (AUC) of the 12-point plasma glucose concentration-time profile divided by 24 hours.|Prior to morning dose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours post morning dose on Days 0 (baseline) and Day 14|Full analysis set defined as all randomized subjects who had taken at least 1 dose of blinded study medication and who had both a baseline and a post-baseline WMDG assessment. Number of participants analyzed was the evaluable participants with a measurement at both baseline and on Day 14.|||milligram/deciliter (mg/dL)||Standard Error|Least Squares Mean
2623072|NCT01933594|Secondary|Change From Baseline in PTEF-b Phosphorylation (pS175+%) in CD4+ T-cells in Cohort 4|Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14) minus the value at baseline.|Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14)|Cohort 4 participants with available data|||percentage of CD4 cells||Inter-Quartile Range|Median
2623073|NCT01933594|Secondary|Change From Baseline in PTEF-b Phosphorylation (pNFKB+%) in CD4+ T-cells in Cohort 4|Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14) minus the value at baseline.|Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14)|Cohort 4 participants with available data|||percentage of CD4 cells||Inter-Quartile Range|Median
2623074|NCT01933594|Secondary|Change From Baseline in PTEF-b Phosphorylation (pNFKB+% and pS175%) in CD8+ T-cells in Cohorts 1-3|"Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Change was calculated as the value at 24 hours after the single administration of Romidepsin or placebo (at entry) minus the value at baseline."|Hour 0 and 24 hours after the single administration of Romidepsin or placebo (at entry)|Cohorts 1-3 participants with available data|||percentage of CD8 cells||Inter-Quartile Range|Median
2623075|NCT01933594|Secondary|Change From Baseline in PTEF-b Phosphorylation (pNFKB+% and pS175%) in CD4+ T-cells in Cohorts 1-3|"Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Change was calculated as the value at 24 hours after the single administration of Romidepsin or placebo (at entry) minus the value at baseline."|Hour 0 and 24 hours after the single administration of Romidepsin or placebo (at entry)|Cohorts 1-3 participants with available data|||percentage of CD4 cells||Inter-Quartile Range|Median
2623076|NCT01933594|Secondary|Change From Baseline in Percentage of CD8+ T-cells Expressing Annexin V and/or 7 Amino-actinomycin D (7-AAD) in Cohort 4|Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at entry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.|Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)|Cohort 4 participants with available data|||percentage of CD8 cells||Inter-Quartile Range|Median
2623077|NCT01933594|Secondary|Change From Baseline in Percentage of CD4+ T-cells Expressing Annexin V and/or 7 Amino-actinomycin D (7-AAD) in Cohort 4|Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at entry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.|Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)|Cohort 4 participants with available data|||percentage of CD4 cells||Inter-Quartile Range|Median
2623078|NCT01933594|Secondary|Change From Baseline in Percentage of CD8+ T-cells Expressing Annexin V and/or 7 Amino-actinomycin D (7-AAD) in Cohorts 1-3|"Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Change was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry) minus the value at baseline."|Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)|Cohorts 1-3 participants with available data|||percentage of CD8 cells||Inter-Quartile Range|Median
2623079|NCT01933594|Secondary|Change From Baseline in Percentage of CD4+ T-cells Expressing Annexin V and/or 7 Amino-actinomycin D (7-AAD) in Cohorts 1-3|"Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Change was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry) minus the value at baseline."|Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)|Cohorts 1-3 participants with available data|||percentage of CD4 cells||Inter-Quartile Range|Median
2623080|NCT01933594|Secondary|Change From Baseline in Cellular Markers of Immune Activation (CD69/CD25 Expression on CD8+ T-cells) in Cohort 4|Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at etnry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.|Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at etnry and day 42), and 10 weeks after the fourth administration (at day 42|Cohort 4 participants with available data|||percentage of CD8 cells||Inter-Quartile Range|Median
2623081|NCT01933594|Secondary|Change From Baseline in Cellular Markers of Immune Activation (CD69/CD25 Expression on CD4+ T-cells) in Cohort 4|Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at etnry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.|Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at etnry and day 42), and 10 weeks after the fourth administration (at day 42)|Cohort 4 participants with available data|||percentage of CD4 cells||Inter-Quartile Range|Median
2623082|NCT01933594|Secondary|Change From Baseline in Cellular Markers of Immune Activation (CD38/HLA-DR Expression on CD8+ T-cells) in Cohort 4|Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at entry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.|Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)|Cohort 4 participants with available data|||percentage of CD8 cells||Inter-Quartile Range|Median
2623083|NCT01933594|Secondary|Change From Baseline in Cellular Markers of Immune Activation (CD38/HLA-DR Expression on CD4+ T-cells) in Cohort 4|Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at entry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.|Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)|Cohort 4 participants with available data|||percentage of CD4 cells||Inter-Quartile Range|Median
2623084|NCT01933594|Secondary|Change From Baseline in Cellular Markers of Immune Activation (CD69/CD25 Expression on CD8+ T-cells) in Cohorts 1-3|"Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Change was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline."|Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)|Cohorts 1-3 participants with available data|||percentage of CD8 cells||Inter-Quartile Range|Median
2623085|NCT01933594|Secondary|Change From Baseline in Cellular Markers of Immune Activation (CD69/CD25 Expression on CD4+ T-cells) in Cohorts 1-3|"Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Change was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline."|Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)|Cohorts 1-3 participants with available data|||percentage of CD4 cells||Inter-Quartile Range|Median
2623086|NCT01933594|Secondary|Change From Baseline in Cellular Markers of Immune Activation (CD38/HLA-DR Expression on CD8+ T-cells) in Cohorts 1-3|"Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Change was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline."|Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)|Cohorts 1-3 participants with available data|||percentage of CD8 cells||Inter-Quartile Range|Median
2623087|NCT01933594|Secondary|Change From Baseline in Cellular Markers of Immune Activation (CD38/HLA-DR Expression on CD4+ T-cells) in Cohorts 1-3|"Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Change was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline."|Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)|Cohorts 1-3 participants with available data|||percentage of CD4 cells||Inter-Quartile Range|Median
2623088|NCT01933594|Secondary|Change From Baseline in CD8+ T Cell Percent in Cohort 4|Change in CD8+ T cell percent from baseline to after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)|Measured through 28 days after the single administration of RMD or placebo (at entry, and days 14, 28 and 42)|Cohort 4 participants did not have CD8+ T cell percent collected||||||
2623089|NCT01933594|Secondary|Change From Baseline in CD4+ T Cell Percent in Cohort 4|Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours post each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 2, 5, 10 and 18 weeks post the fourth administration minus the value at baseline|Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42), and 2, 5, 10 and 18 weeks after the fourth administration (at day 42)|Cohort 4 participants with available data|||percentage of CD4 cells||Inter-Quartile Range|Median
2623090|NCT01933594|Secondary|Change From Baseline in CD4+ and CD8+ T Cell Percent in Cohorts 1-3|Change in CD4+ and CD8+T cell percent from baseline to after the single administration of Romidepsin or placebo|Measured through participant's last study visit|Cohorts 1-3 participants did not have CD4+ and CD8+ T cell percent collected||||||
2623091|NCT01933594|Secondary|Number of Participants With Reported Grade 2-4 AEs in Cohort 4|Number of participants with reported grade 2-4 adverse events including signs/symptoms, lab toxicities, and clinical events that are at least possibly related to study treatment. The DAIDS AE Grading Table (Version 1.0) was used.|Measured from study entry to off study|Cohort 4 participants|||Participants|||Count of Participants
2623092|NCT01933594|Secondary|Number of Participants With Reported Grade 2-4 AEs in Cohorts 1-3|Number of participants with reported grade 2-4 adverse events including signs/symptoms, lab toxicities, and clinical events that are at least possibly related to study treatment. The DAIDS AE Grading Table (Version 1.0) was used.|Measured from study entry to off study|Cohorts 1-3 participants|||Participants|||Count of Participants
2623093|NCT01933594|Secondary|HIV-1 RNA Levels in Cohort 4|HIV-1 RNA levels at 7 days after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)|7 days after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)|Cohort 4 participants with available data|||Participants|||Count of Participants
2623094|NCT01933594|Secondary|HIV-1 RNA Levels in Cohorts 1-3|HIV-1 RNA levels at 7 days after the single administration of Romidepsin or placebo (at entry)|7 days after the administration of Romidepsin or placebo (at entry)|Cohorts 1-3 participants|||Participants|||Count of Participants
2623095|NCT01933594|Secondary|PK Parameters for Romidepsin and Co-administered Antiretroviral Drugs (Dolutegravir or Raltegravi) in Cohort 4|"PK concentration (ng/mL) for Romidepsin pre and post the third and fourth administrations of Romidepsin or placebo.~PK concentration (ng/mL) for co-administered antiretroviral drugs (Dolutegravir [DTG], or Raltegravir [RAL]) 24 hours after the third and fourth administrations of Romidepsin or placebo."|Pre, post and 24 hours after the third and fourth administrations of Romidepsin or placebo (at days 28 and 42)|"For Romidepsin PK parameters: Cohort 4 participants who received the third and fourth Romidepsin infusion.~For co-administered antiretroviral drugs PK parameters: Cohort 4 participants who received the third and fourth Romidepsin or placebo infusion."|||ng/mL||Inter-Quartile Range|Median
2623096|NCT01933594|Secondary|PK Parameters for Romidepsin and Co-administered Antiretroviral Drugs (Efavirenz, Dolutegravir, or Raltegravir) in Cohorts 1-3|"Hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Hour 4 is at the completion of Romidepsin or placebo administration. Hours 6, 12 and 24 are 2, 8 and 20 hours after the completion of Romidepsin or placebo administration.~PK concentration (ng/mL) for Romidepsin at hours 0, 4, 6, 12 and 24. PK concentration (ng/mL) for co-administered antiretroviral drugs (Efavirenz [EFV], Dolutegravir [DTG], or Raltegravir [RAL]) at hours 0 and 24."|At hours 0, 4, 6, 12 and 24|For Romidepsin PK parameters: Cohorts 1-3 participants who received Romidepsin. For co-administered antiretroviral drugs PK parameters: Cohorts 1-3 participants.|||ng/mL||Inter-Quartile Range|Median
2623097|NCT01933594|Secondary|Change From Baseline in Total HIV-1 DNA in PBMCs in Cohort 4|Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration minus the value at baseline.|Pre-entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14)|Cohort 4 participants with available data|||log10 (copies/10^6 PBMCs)||Inter-Quartile Range|Median
2623098|NCT01933594|Secondary|Change From Baseline in Total HIV-1 DNA in Resting or Total CD4 T Cells in Cohorts 1-3|Baseline is defined as the pre-entry value. Change was calculated as the value at 24 hours and 14 days after administration of Romidepsin or placebo (at entry) minus the value at baseline.|Pre-entry, 24 hours and 14 days after the single administration of Romidepsin or placebo (at entry)|Cohorts 1-3 participants with available data|||log10 (copies/10^6 resting CD4 cells)||Inter-Quartile Range|Median
2623099|NCT01933594|Secondary|Change From Baseline in Histone Acetylation in (Median FITC Ac-histone) in CD3+ Cells in Cohort 4|"Baseline is defined as the value right before the first administration of Romidepsin or placebo (at entry).~Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration minus the value at baseline.~Median Fluorescent Intensity (MFI) data describes a shift in the expression of a fluorescently labeled marker on a population of cells. The reported MFI is an arbitrary value dependent on the voltage applied to the corresponding flow cytometer detector."|Entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42), and 72 hours after the second administration (at day 14)|Cohort 4 participants with available data|||arbitrary units||Inter-Quartile Range|Median
2623100|NCT01933594|Secondary|Change From Baseline in Histone Acetylation (Median FITC Ac-Histone) in CD3+ Cells in Cohorts 1-3|"Baseline is defined as the value at Hour 0, right before the single administration of Romidepsin or placebo.~Change was calculated as the value at 24 hours after administration of Romidepsin or placebo (at entry) minus the value at baseline.~Median Fluorescent Intensity (MFI) data describes a shift in the expression of a fluorescently labeled marker on a population of cells. The reported MFI is an arbitrary value dependent on the voltage applied to the corresponding flow cytometer detector."|Hour 0 and 24 hours after the single administration of RMD or placebo (at entry)|Cohorts 1-3 participants with available data|||arbitrary units||Inter-Quartile Range|Median
2623101|NCT01933594|Secondary|Change From Baseline in Cell-associated HIV-1 RNA Levels in PBMCs in Cohort 4|Baseline is defined as the pre-entry value. Change was calculated as the value at 72 hours after the second administration of Romidepsin or placebo (at day 14) minus the value at baseline.|Pre-entry and 72 hours after the second administration of Romidepsin or placebo (at day 14)|Cohort 4 participants|||log10 copies/mL||Inter-Quartile Range|Median
2623102|NCT01933594|Secondary|Change From Baseline in Cell-associated HIV-1 RNA Levels in Resting CD4 T Cells in Cohorts 1-3|Baseline is defined as the pre-entry value. Change was calculated as the value at 14 days after administration of Romidepsin or placebo (at entry) minus the value at baseline.|Pre-entry and 14 days after the administration of RMD or placebo (at entry)|Cohorts 1-3 participants with available data|||log10 copies/mL||Inter-Quartile Range|Median
2623103|NCT01933594|Secondary|Change From Baseline in Plasma HIV-1 RNA Levels as Detected by Single Copy Assay in Cohort 4|Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 72 hours after the second administration of Romidepsin or placebo (at day 14) minus the value at baseline.|Pre-entry, entry and 72 hours after the second administration of Romidepsin or placebo (at day 14)|Cohort 4 participants|||log10 copies/mL||Inter-Quartile Range|Median
2623104|NCT01933594|Secondary|Change From Baseline in Plasma HIV-1 RNA Levels as Detected by Single Copy Assay in Cohorts 1-3|Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 6 hours, 12 hours, 7 days, 14 days and 28 days after administration of Romidepsin or placebo (at entry) minus the value at baseline.|Pre-entry, entry, 6 hours, 12 hours, 7 days, 14 days and 28 days after the single administration of Romidepsin or placebo (at entry)|Cohorts 1-3 participants with available data|||log10 copies/mL||Inter-Quartile Range|Median
2623105|NCT01933594|Primary|Change From Baseline in Cell-associated HIV-1 RNA Levels in PBMCs in Cohort 4|Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) minus the value at baseline.|Pre-entry, entry and 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)|Cohort 4 participants with available data|||log10 (copies/10^6 PBMCs)||Inter-Quartile Range|Median
2623106|NCT01933594|Primary|Change From Baseline in Cell-associated HIV-1 RNA Levels in Resting CD4 T-cells in Cohorts 1-3|Baseline is defined as the pre-entry value. Change was calculated as the value at 24 hours after administration of Romidepsin or placebo (at entry) minus the value at baseline.|Pre-entry and 24 hours after the single administration of Romidepsin or placebo (at entry)|Cohorts 1-3 participants|||log10 (copies/10^6 resting CD4 cells)||Inter-Quartile Range|Median
2623107|NCT01933594|Primary|Change From Baseline in Plasma HIV-1 RNA Levels as Detected by Single Copy Assay in Cohort 4|Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) minus the value at baseline.|Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)|Cohort 4 participants|||log10 copies/mL||Inter-Quartile Range|Median
2623108|NCT01933594|Primary|Change From Baseline in Plasma HIV-1 RNA Levels as Detected by Single Copy Assay in Cohorts 1-3|"Baseline is defined as the average of the pre-entry and entry values. Hour 24/48 is defined as the average of values at 24 and 48 hours after the single administration of Romidepsin or placebo (at study entry).~Change was calculated as the value at hour 24/48 minus the value at baseline."|Pre-entry, entry, 24 and 48 hours after the single administration of Romidepsin or placebo (at entry)|Cohorts 1-3 participants|||log10 copies/mL||Inter-Quartile Range|Median
2623109|NCT01933594|Primary|Proportion of Participants With Grade 3 or Higher Adverse Events (AEs) in Cohort 4 Romidepsin Arm|Proportion of participants with Grade 3 or Higher Adverse Events (AEs) in Cohort 4 Romidepsin Arm, including signs/symptoms, lab toxicities, and /or clinical events probably, possibly, or definitely related to study treatment (as judged by the core team, blinded to treatment arm). The DAIDS AE Grading Table (Version 1.0) was used.|Measured from the time of the first Romidepsin administration through 28 days after the last administration (at day 42)|Participants in Cohort 4 who received Romidepsin|||proportion of participants||95% Confidence Interval|Number
2623110|NCT01933594|Primary|Proportion of Participants With Grade 3 or Higher Adverse Events (AEs) in Cohorts 1-3 Romidepsin Arms|Proportion of participants with Grade 3 or higher adverse events (AEs) in Cohorts 1-3 Romidepsin Arms, including signs/symptoms, lab toxicities, and /or clinical events probably, possibly, or definitely related to study treatment (as judged by the core team, blinded to treatment arm). The DAIDS AE Grading Table (Version 1.0) was used.|Measured from the time of Romidepsin administration (at entry) until 28 days after the administration|Participants in Cohorts 1-3 who received Romidepsin|||proportion of participants||95% Confidence Interval|Number
2623111|NCT01933464|Other Pre-specified|Adverse Events|Adverse events will be recorded at each visit and their likelihood to the study interventions will be recorded|Baseline, and then 3, 6 and 8 weeks after beginning study intervention|||||||
2623112|NCT01933464|Secondary|Change in Matrix Metalloproteinase Activity|We will compare subjects' matrix metalloproteinase activity levels at the beginning of the study (baseline) to those at the end of the study (8 weeks after baseline). Tape stripping methods were used to isolate matrix metalloproteinase(MMP). Total-MMP activity was determined with total-MMP fluorogenic substrate (5 μM; Enzo Life Sciences), in protein extracts, and subsequently measuring activity (Vmax/sec) at a fluorescence excitation wavelength 328 nm and an emission wavelength of 400 nm in a fluorescence plate reader (Gemini EM microplate spectrofluorometer).|Baseline and 8 weeks||||Vmax/sec||Inter-Quartile Range|Median
2623113|NCT01933464|Secondary|Matrix Metalloproteinase Activity Levels|Tape stripping methods were used to isolate matrix metalloproteinase(MMP). Total-MMP activity was determined with total-MMP fluorogenic substrate (5 μM; Enzo Life Sciences), in protein extracts, and subsequently measuring activity (Vmax/sec) at a fluorescence excitation wavelength 328 nm and an emission wavelength of 400 nm in a fluorescence plate reader (Gemini EM microplate spectrofluorometer).|Baseline||||Vmax/sec||Inter-Quartile Range|Median
2623114|NCT01933464|Primary|Change in Facial Erythema|We will measure participants' change in facial erythema over the course of the study. The change in facial erythema is measured as a difference between the final (8 weeks after baseline) and baseline visit of the sum of the CEA scores determined from the 5 designated locations (nose, glabella, left cheek, right cheek, and chin). The scale range from -20 to 20. A negative score indicates improvement of facial erythema from baseline to 8 weeks after baseline. A positive score indicates worsening of facial erythema from baseline to 8 weeks after baseline.|Baseline and 8 weeks||||score on a scale||Standard Deviation|Mean
2623115|NCT01933464|Primary|Facial Erythema|Facial erythema will be measured using the Clinician's Erythema Assessment(CEA) applied to 5 areas of the subject's face (chin, nose, glabella, left cheek, right cheek), as well as using measurements from a colorimeter applied to each of the 5 locations previous mentioned. Each area is rated from 0-4, where 4 represents the most facial erythema (worst outcome). The scores for the 5 locations are summed with a CEA total score scale of 0-20.|Baseline||||score on a scale||Standard Deviation|Mean
2623116|NCT01933425|Secondary|Surgical Conditions During Suturing of the Abdominal Fascia|Optimal (score 1) Good (score 2) Acceptable (score 3) Poor (score 4)|1 hour|Evaluation of surgical conditions was compared using Mann–Whitney U-test.|||participants|||Number
2623117|NCT01933425|Secondary|Intraabdominal Distance (Centimeters)|Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 8 mmHg with and without deep neuromuscular blockade (PTC 0-1).|1 hour|Comparisons of changes in distances were performed with paired t-test|||centimeters||95% Confidence Interval|Median
2623118|NCT01933425|Primary|Intraabdominal Distance (Centimeters)|Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1).|1 hour|Comparisons of changes in distances were performed with paired t-test.|||centimeters||Full Range|Median
2623119|NCT01933399|Secondary|Change Score in the Patient Specific Activity Scale|Change score from baseline and the score at the second week. Compare score change to the minimal clinically important difference and analyze for statistical significance between the baseline and the 2nd week score, and the statistical difference in the change scores across the 3 groups. Scores from 0 to 10 with a higher score representing higher function and a lower score representing a decrease function.|Baseline and 2-weeks||||units on a scale||95% Confidence Interval|Mean
2623136|NCT01932970|Other Pre-specified|Percentage of Participants With Symptomatic Hypocalcemia During the 4-week Treatment Period|Hpocalcemia was used for events of decreased calcium accompanied by clinical signs and symptoms of hypocalcemia.|From the first dose of study drug up to 30 days after the last dose; 8 weeks|Participants who received at least one dose of study drug|||percentage of participants||95% Confidence Interval|Number
2623137|NCT01932970|Other Pre-specified|Number of Participants With Adverse Events||From the first dose of study drug up to 30 days after the last dose; 8 weeks|All participants who received at least one dose of study drug|||participants|||Number
2623120|NCT01933399|Primary|Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI)|Change score from baseline and the score at the second week. The Oswestry Disabilty Index is a 100 point self-assessment of disabilty due to lower back pain or complications from lower back pain. A score of 40 or more points is interpreted as signficant disability due to lower back pain. A score between 20 and 40 respresents disability, but the individual is still able to function to some degree with activities of daily living, but has to modify their behavior. A score less than 20 implies that the disabilty due to the lower back pain is not greatly impacting a wide range of functions. Compare score change to the minimal clinically important difference between the baseline and the 2nd week score, and the difference in the change scores across the 3 groups.|Baseline and 2 weeks||||units on a scale||95% Confidence Interval|Mean
2623121|NCT01933334|Secondary|University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores|UCLA SCTC GIT Scale 2.0 is a 34-item self-administered questionnaire to obtain participant's assessment of the frequency of GI symptoms in preceding 7 days and how symptoms affected his/her life. All but 2 items were scored on a 0 to 3 scale (0=better health, 3=worse health); remaining 2 items were scored as 0 (better health) and 1 (worse health). The 34 items are divided into seven scales (reflux, distention/bloating, fecal soilage, diarrhea, social functioning, emotional well-being, and constipation). Individual scale score was calculated as the average of the items in the scale. Individual scale score ranged from 0 to 3 for reflux, distention/bloating, fecal soilage, social functioning, and emotional well-being; 0 to 2 for diarrhea; and 0 to 2.5 for constipation. A total score was also calculated as the average of 6 of the 7 scales (omitting constipation) and ranged from 0 to 2.83. For individual and total scores 0 indicated better health and higher score indicates worse health.|Baseline, Weeks 4, 8, 12, and 16|Safety population. n = number of participants analyzed at specified time.|||units on a scale||Standard Deviation|Mean
2623122|NCT01933334|Primary|Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)|An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From baseline up to 28 days after the last dose of study drug (last dose = Week 16)|Safety population included all randomized participants who provided written informed consent and received at least one dose of study treatment.|||percentage of participants|||Number
2623123|NCT01933334|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs)|Percentage of participants who had treatment-emergent AEs, defined as newly occurring or worsening after first dose. Relatedness to (study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|From baseline up to 28 days after the last dose of study drug (last dose = Week 16)|Safety population included all randomized participants who provided written informed consent and received at least one dose of study treatment.|||percentage of participants|||Number
2623124|NCT01933243|Other Pre-specified|Number of Participant Tolerating Saliva Collection and 24 Hour Heart Rate Monitor Use|"At baseline, 6 weeks, and 12 weeks, study participants were asked to collect salivary samples 5 times over a 24 hour period. In addition, participants were asked to wear a 24 hour heart monitor during this same 24 hour interval. Compliance wtth completion of these physiological measures was assessed as follows:~For saliva collection, compliance was assessed by return of 5 full vials of saliva with record of time collected.~For 24 hour heart rate monitor, compliance was assessed by return of monitor with then downloading of data to confirm that the participant wore the device during the specified time interval."|Baseline, 6 weeks, and 12 weeks|All participants completing at least a baseline visit.|||Participants|||Count of Participants
2623125|NCT01933243|Secondary|Beck Anxiety Inventory—Trait (BAIT)|The BAIT is a 21-item self-report measure of anxiety severity rated on a 4-point Likert scale (0= rarely or never; 3= almost always). It has shown acceptable reliability and validity in an adolescent psychiatric inpatient population. BAIT scores over 26 indicate severe anxiety, scores 16-25 indicate moderate anxiety, scores 8-15 indicate mild anxiety, and scores 0-7 indicate a minimal level of anxiety. We chose to measure trait anxiety to examine beyond meal-related (state) anxiety.|Baseline, 6 weeks, and 12 weeks|All participants who completed a baseline study visit|||Score on a scale||Standard Error|Mean
2623126|NCT01933243|Primary|Medication Side Effects Score|"At 6 and 12 weeks, medication tolerability was assessed via self-report of nine potential side effects (e.g. diarrhea, burping). Participants were asked whether they experienced these side effects never, rarely, occasionally, frequently, or very frequently. Individual responses were assigned a numeric equivalent from 0 to 4, and summed for a total side effect score ranging from 0 to 36. Higher scores indicated greater frequency of side effects and lower medication tolerability."|6 and12 weeks|Participants who completed at least a baseline study visit.|||Score on a scale||Standard Error|Mean
2623127|NCT01933230|Primary|To Determine if Neck Cooling Affects Brain Temperature.||During the 2 hours of neck cooling|||||||
2623128|NCT01933230|Primary|To Determine if Neck Cooling Affects Intracranial Pressure||During 2 hours of neck cooling|||||||
2623129|NCT01933230|Primary|Temperature Reduction by 1 Degree Per Hour in the ICU Setting.|Temperature reduction by 1 degree per hour in the Intensive Care Unit setting.|During the 2 hours of neck cooling||||degrees celsius||Standard Deviation|Mean
2623130|NCT01933113|Primary|Change in Metabolic Rate|Metabolic rate of subjects will be measured while at Pennington Biomedical Research Center. Percentage of change in these parameters will be measured.|One week of testing for each subject.||||percentage of increase in REM and SEE||Standard Deviation|Median
2623131|NCT01933048|Other Pre-specified|Feasibility of Self-administration Following Vaccine Administration||28+/- 7 days post-vaccination|Numbers include participants randomized to the SA group only.|||participants|||Number
2623132|NCT01933048|Other Pre-specified|Feasibility of Self-administration Prior to Vaccine Administration||28+/- 7 days post-vaccination||||participants|||Number
2623133|NCT01933048|Secondary|Difference and Proportion in Seroconversion of Subjects||28+/- 7 days post-vaccination||||participants|||Number
2623134|NCT01933048|Secondary|Difference and Proportion in Seroresponse of Subjects||28+/- 7 days post-vaccination||||participants|||Number
2623141|NCT01932788|Primary|Number of Participants With Greater Than 100 Nmol/L 25(OH)D (Converted Vitamin D)|Because the primary endpoint of the study is change in 25(OH)D from baseline to delivery, the primary analysis will be restricted to participants who had greater than 100 nmol/L of 25(OH)D. Recording will be counts of participants in each arm that achieved greater than the 100 nmol/L threshold.|20 weeks||||Participants|||Count of Participants
2623142|NCT01932762|Secondary|Percentage of Participants Achieving SVR24|SVR24 was defined as HCV RNA <25 IU/mL, either TD(u) or TND, at 24 weeks after the end of all study therapy. The percentage of participants with SVR24 and accompanying 95% CIs were reported for each treatment arm of the PP Population.|24 weeks after end of all therapy (Study Week 36)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.|||percentage of participants||95% Confidence Interval|Number
2623143|NCT01932762|Secondary|Percentage of Participants Achieving SVR4|SVR4 was defined as HCV RNA <25 IU/mL, either TD(u) or TND, at 4 weeks after the end of all study therapy. The percentage of participants with SVR4 and accompanying 95% CIs were reported for each treatment arm of the PP Population.|4 weeks after end of all therapy (Study Week 16)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.|||percentage of participants||95% Confidence Interval|Number
2623144|NCT01932762|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment By Timepoint|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. The Roche COBAS™ Taqman™ HCV Test (v.2.0) has a lower limit of quantification (LLoQ) of 25 IU/ml and a limit of detection of 9.3 IU/ml. The percentage of participants with HCV RNA levels <25 IU/ml (either TD[u] or TND) and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population.|From TW 2 through TW 12 (up to 12 weeks)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.|||percentage of participants||95% Confidence Interval|Number
2623145|NCT01932762|Secondary|Percentage of Participants Achieving Undetectable HCV RNA During Treatment By Timepoint|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2, TW4, and TW12 for each treatment arm of the PP Population.|From TW 2 through TW 12 (up to 12 weeks)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy and with no important protocol deviations) with available data.|||percentage of participants||95% Confidence Interval|Number
2623146|NCT01932762|Secondary|Mean Time to First Achievement of Undetectable HCV RNA During Treatment|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at TWs 1, 2, 4, 8, and 12. Undetectable HCV RNA (or TND) was defined as below the 9.3 IU/ml limit of detection. Kaplan Meier summary statistics were calculated for each treatment arm in the Full Analysis Set (FAS).|From TW1 until first achievement of undetectable HCV RNA (up to 12 weeks)|FAS; all randomized participants who received ≥1 dose of study therapy. Participants in the FAS not achieving TND were censored from the analysis.|||days||Standard Error|Mean
2623147|NCT01932762|Primary|Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Drug-Related AEs, Drug-Related SAEs, or Discontinuation of Study Treatment Due to AE During the Treatment Period and First 14 Follow-up Days|AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. An SAE was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event. The investigator determined the relationship of the AE to the treatment as unrelated or possibly, probably, or definitely related.|Treatment period plus the first 14 days of follow-up (up to 14 weeks)|All-Subjects-As-Treated (ASAT) Population; all randomized participants who received ≥ 1 dose of study therapy. The percentage of participants with specific AEs and accompanying 95% CI were reported for each treatment arm.|||percentage of participants||95% Confidence Interval|Number
2623148|NCT01932762|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After The End of Study Therapy (SVR12)|SVR12 was defined as Hepatitis C Virus ribonucleic acid (HCV RNA) <25 IU/mL, either target detected but unquantifiable (TD[u]) or target not detected (TND), at 12 weeks after the end of all study therapy. The percentage of participants with SVR12 and accompanying 95% confidence intervals (CIs) were reported for each treatment arm in the Per-Protocol (PP) Population.|12 weeks after end of all therapy (Study Week 24)|All participants in the PP Population (all randomized participants receiving ≥1 dose of study therapy with no important protocol deviations) with available data.|||percentage of participants||95% Confidence Interval|Number
2623149|NCT01932697|Other Pre-specified|E6/E7 Messenger Ribonucleic Acid (mRNA) of HPV16, Assessed on a Chromogenic RNA in Situ Hybridization (ISH) Assay Called RNAscope|These markers will be correlated with clinical endpoints like acute adverse events, cumulative incidence rates of local/regional failure, overall survival, and disease-free survival.|Baseline|||||||
2623150|NCT01932697|Other Pre-specified|Changes in Transforming Growth Factor (TGF)-beta1 Levels|These markers will be correlated with clinical endpoints like acute adverse events, cumulative incidence rates of local/regional failure, overall survival, and disease-free survival.|Baseline to 1 week post-radiation|||||||
2623151|NCT01932697|Secondary|1-year Post-treatment QOL as Measured by the Three-level Version of the EuroQol Five-dimensional Instrument (EQ-5D-3L)|1-year post-treatment QOL as measured by the three-level version of the EuroQol five-dimensional instrument (EQ-5D-3L)|1 year post-treatment||2020-07-31|07/2020||||
2623152|NCT01932697|Secondary|1-year Post-treatment QOL as Measured by the European Organization for Research and Treatment for Cancer QOL Questionnaire for Head and Neck Cancer Module 35 (EORTC-QLQ HN35)|1-year post-treatment QOL as measured by the European Organization for Research and Treatment for Cancer QOL Questionnaire for Head and Neck Cancer Module 35 (EORTC-QLQ HN35)|1 year post-treatment||2020-07-31|07/2020||||
2623153|NCT01932697|Secondary|1 Year Post-treatment in QOL Measured Using the Functional Assessment of Cancer Therapy Head and Neck (FACT H& N) (Version 4)|1 year post-treatment in QOL measured using the Functional Assessment of Cancer Therapy Head and Neck (FACT H& N) (version 4)|1 year post-treatment||2020-07-31|07/2020||||
2623154|NCT01932697|Secondary|Change From Baseline to 12 Months Post-RT in Swallow Function as Measured by the Pharyngeal Total Modified Barium Swallow Impairment Profile|Swallowing will be scored (yes, no) for aspiration, penetration, velopharyngeal incompetence, epiglottic inversion, tongue base retraction, and pharyngeal swallow response using the metric outlined by Eisbruch et al.|Baseline to up to 12 months post-treatment||2020-07-31|07/2020||||
2623155|NCT01932697|Secondary|2-year Distant Metastasis-free Survival Rate|The 2-year Distant metastasis-free survival rate (percentage) is defined as the percentage of patients with no distant recurrence or death 2 years after study registration.|Up to 2 years||||percentage of patients|||Number
2623156|NCT01932697|Secondary|2-year Progression-free Survival (PFS)|The distribution of PFS will be estimated using the method of Kaplan-Meier.|From registration to the first of either disease recurrence or death, assessed up to 2 years||||percentage of patients|||Number
2623157|NCT01932697|Secondary|2-year Overall Survival (OS) Rate|The distribution of OS will be estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 2 years||||percentage of patients|||Number
2623158|NCT01932697|Secondary|Incidence of Grade 3 or Higher Mucositis Oral|The overall percentage of patients experiencing grade 3 or higher mucositis oral graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 are reported below.|Up to 4 months post-hyperfractionated radiation therapy||||percentage of patients|||Number
2623159|NCT01932697|Primary|2-year Loco-regional Tumor Control (LRC) Rate|The 2-year loco-regional tumor control (LRC) rate (percentage) is defined as the percentage of patients with no local/regional recurrence or death 2 years after study registration.|Up to 2 years||||percentage of patients|||Number
2623160|NCT01932606|Secondary|Change in Stroke Volume After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Stroke volume is the amount of blood pumped out of the heart (left ventricle - to the body) during each contraction.|baseline, approximately 30 minutes after study drug administration||||ml||Standard Deviation|Mean
2623161|NCT01932606|Secondary|Change in Cardiac Output After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Cardiac output is equal to the stroke volume (the amount of blood pumped from a ventricle in a single heartbeat) times the heart rate.|baseline, approximately 30 minutes after study drug administration||||L/min||Standard Deviation|Mean
2623162|NCT01932606|Secondary|Change in Arteriovenous Oxygen Difference After Study Drug (Exercise)|Arteriovenous oxygen difference is the difference in the oxygen content of the blood between the arterial blood and the venous blood. It is an indication of how much oxygen is removed from the blood in capillaries as the blood circulates in the body.|baseline, approximately 30 minutes after study drug administration||||ml/dl||Standard Deviation|Mean
2623163|NCT01932606|Secondary|Change in Oxygen Consumption (VO_2) After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration||||ml/min||Standard Deviation|Mean
2623164|NCT01932606|Secondary|Change in LVSW After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Stroke work refers to the work done by the ventricle to eject a volume of blood (i.e., stroke volume) into the aorta. Ventricular stroke work can be estimated as the product of stroke volume and mean aortic pressure during ejection.|baseline, approximately 30 minutes after study drug administration||||g/beat||Standard Deviation|Mean
2623165|NCT01932606|Secondary|Change in SVR After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Systemic vascular resistance (SVR) refers to the resistance to blood flow offered by all of the systemic vasculature, excluding the pulmonary vasculature.|baseline, approximately 30 minutes after study drug administration||||dyne/s * cm^5||Standard Deviation|Mean
2623166|NCT01932606|Secondary|Change in PA Compliance After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Pulmonary artery compliance is an index of the elasticity of the blood vessel, an indication of arterial stiffness.|baseline, approximately 30 minutes after study drug administration||||ml/mm Hg||Standard Deviation|Mean
2623167|NCT01932606|Secondary|Change in PVR After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Pulmonary Vascular Resistance (PVR) is the resistance to flow that must be overcome to push blood through the pulmonary vasculature. Acute and chronic lung disease can both cause an increase in PVR. Chronic PVR can lead to right sided heart failure.|baseline, approximately 30 minutes after study drug administration||||mm Hg/L/min||Standard Deviation|Mean
2623168|NCT01932606|Secondary|Change in Blood Pressure After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration||||mm Hg||Standard Deviation|Mean
2623169|NCT01932606|Secondary|Change in Heart Rate After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration||||beats/minute||Standard Deviation|Mean
2623170|NCT01932606|Secondary|Change in Central Pressures After Study Drug (Exercise)|Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration||||mm Hg||Standard Deviation|Mean
2623573|NCT01929460|Primary|Number of Patients With Pancreas Cyst Infection After EUS-guided Pancreatic Cyst Aspiration|first time point (number of patients with pancreas cyst infection after EUS-guided pancreatic cyst aspiration)|At 2 weeks after procedure||||participants|||Number
2623171|NCT01932606|Secondary|Change in Stroke Volume After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Stroke volume is the amount of blood pumped out of the heart (left ventricle - to the body) during each contraction.|baseline, approximately 30 minutes after study drug administration||||ml||Standard Deviation|Mean
2623172|NCT01932606|Secondary|Change in Cardiac Output After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) The volume of blood pumped per minute by each ventricle of the heart. Cardiac output is equal to the stroke volume (the amount of blood pumped from a ventricle in a single heartbeat) times the heart rate.|baseline, approximately 30 minutes after study drug administration||||L/min||Standard Deviation|Mean
2623173|NCT01932606|Secondary|Change in Arteriovenous Oxygen Content Difference After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Arteriovenous oxygen difference is the difference in the oxygen content of the blood between the arterial blood and the venous blood. It is an indication of how much oxygen is removed from the blood in capillaries as the blood circulates in the body.|baseline, approximately 30 minutes after study drug administration||||ml/dl||Standard Deviation|Mean
2623174|NCT01932606|Secondary|Change in Oxygen Consumption (VO_2) After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration||||ml/min||Standard Deviation|Mean
2623175|NCT01932606|Secondary|Change in Left Ventricular Stroke Work (LVSW) After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Stroke work refers to the work done by the ventricle to eject a volume of blood (i.e., stroke volume) into the aorta. Ventricular stroke work can be estimated as the product of stroke volume and mean aortic pressure during ejection.|baseline, approximately 30 minutes after study drug administration||||g/beat||Standard Deviation|Mean
2623176|NCT01932606|Secondary|Change in Systemic Vascular Resistance (SVR) After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Systemic vascular resistance (SVR) refers to the resistance to blood flow offered by all of the systemic vasculature, excluding the pulmonary vasculature.|baseline, approximately 30 minutes after study drug administration||||dyne/s * cm^5||Standard Deviation|Mean
2623177|NCT01932606|Secondary|Change in Pulmonary Artery (PA) Compliance After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Pulmonary artery compliance is an index of the elasticity of the blood vessel, an indication of arterial stiffness.|baseline, approximately 30 minutes after study drug administration||||ml/mm Hg||Standard Deviation|Mean
2623178|NCT01932606|Secondary|Change in Pulmonary Vascular Resistance (PVR) After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Pulmonary Vascular Resistance (PVR) is the resistance to flow that must be overcome to push blood through the pulmonary vasculature. Acute and chronic lung disease can both cause an increase in PVR. Chronic PVR can lead to right sided heart failure.|baseline, approximately 30 minutes after study drug administration||||mm Hg/L/min||Standard Deviation|Mean
2623179|NCT01932606|Secondary|Change in Blood Pressure After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration||||mm Hg||Standard Deviation|Mean
2623180|NCT01932606|Secondary|Change in Heart Rate After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration||||beats/minute||Standard Deviation|Mean
2623181|NCT01932606|Secondary|Change in Central Pressures After Study Drug (Resting)|Values are resting values after receiving study drug minus resting values before study drug (on the same day.)|baseline, approximately 30 minutes after study drug administration||||mm Hg||Standard Deviation|Mean
2623182|NCT01932606|Primary|Exercise Pulmonary Capillary Wedge Pressure (PCWP)|Pulmonary capillary wedge pressure (PCWP) provides an indirect estimate of left atrial pressure (LAP). PCWP is the pressure measured by wedging a pulmonary catheter with an inflated balloon into a small pulmonary arterial branch.|during repeat exercise run, approximately 30 minutes after study drug administration||||mm Hg||Standard Deviation|Mean
2623183|NCT01932437|Secondary|Number of Participants With Anti-ETI-204 Antibodies|Blood samples were collected and serum samples were assayed at an initial dilution of 1:10. Samples that were positive at the 1:10 dilution were serially diluted 1:2 and assayed until a negative result was attained. The titer of the most dilute sample yielding a positive result was recorded as the titer for that time point. Immunogenicity was measured by the number of participants in each study arm with anti-ETI-204 antibody values at Days 8, 43 or 71 ≥ 4-times higher than at baseline, or if the titer was negative at baseline, the post-treatment sample(s) required a titer of at least 1:20 for it to be considered positive.|Pre-dose and on Days 10, 43, and 71 after the IM injection of ETI-204 or placebo on Day 1.|All subjects in the Safety Population who received either ETI-204 IM or placebo.|||Participants|||Count of Participants
2623184|NCT01932437|Secondary|Apparent Clearance (CL/F)|Blood samples were obtained and serum concentrations were determined for free ETI-204 using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.|The PK Population consisted of all subjects who received ETI-204 IM and had at least one valid PK parameter.1 subject in Cohort 2 was excluded because the dosing record was missing. For 4 subjects (1 in Cohort 2, 1 in Cohort 4, and 2 in Cohort 5) the extrapolated portion of AUC0-inf was >20%; therefore, AUC0-inf-based parameters were not recorded.|||Liters/day||Standard Deviation|Mean
2623220|NCT01931956|Other Pre-specified|Change in 6-Minute Walk Test (6MWT)|Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes.|At Baseline and 12 months|"EU arm participants were not analyzed due to serious/life-threatening conditions, the 6MWT was not administered to all patients at baseline.Therefore, paired data at 1 year were not available for EU arm.~The number of participants analyzed includes subjects who had available follow up data at that time frame in CU, HR and Non-HR arms."|||Meters||Standard Deviation|Mean
2623185|NCT01932437|Secondary|Half-life (t1/2)|Blood samples were obtained and serum concentrations were determined for free ETI-204 using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.|The PK Population consisted of all subjects who received ETI-204 IM and had at least one valid PK parameter. One subject in Cohort 2 was excluded from the PK Population because the dosing record was missing.|||days||Standard Deviation|Mean
2623186|NCT01932437|Secondary|Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf)|Blood samples were obtained and serum concentrations were determined for free ETI-204 using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.|The PK Population consisted of all subjects who received ETI-204 IM and had at least one valid PK parameter. 1 subject in Cohort 2 was excluded because the dosing record was missing. For 4 subjects (1 in Cohort 2, 1 in Cohort 4. and 2 in Cohort 5) the extrapolated portion of AUC0-inf was >20%; therefore, AUC0-inf was not recorded.|||µg.day/mL||Standard Deviation|Mean
2623187|NCT01932437|Secondary|Area Under the Concentration-Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last)|Blood samples were obtained and serum concentrations were determined for free ETI-204 using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.|The PK Population consisted of all subjects who received ETI-204 IM and had at least one valid PK parameter. One subject in Cohort 2 was excluded from the PK population because the dosing record was missing.|||µg.day/mL||Standard Deviation|Mean
2623188|NCT01932437|Secondary|Time to Maximum Observed Plasma Concentration of ETI-204 (Tmax)|Blood samples were obtained and serum concentrations were determined for free ETI-204 using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day 1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.|The PK Population consisted of all subjects who received ETI-204 IM and had at least one valid PK parameter. One subject in Cohort 2 was excluded from the PK Population because the dosing record was missing.|||days||Full Range|Median
2623189|NCT01932437|Secondary|Maximum Observed Plasma Concentration of ETI-204 (Cmax)|Blood samples were obtained and serum concentrations were determined for free ETI-204 using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|Pre-dose and 1.5, 4, 8, 24, 36, 48, 72 hours after the IM injection of ETI-204 on Day1, and on Days (7), 10, 15, 29, 43, and 71. A Day 7 sample was not included in the profile until the dose had escalated to 20 mg/kg.|The Pharmacokinetic (PK) Population consisted of all subjects who received ETI-204 IM and had at least one valid PK parameter. One subject in Cohort 2 was excluded from the PK Population because the dosing record was missing.|||µg/mL||Standard Deviation|Mean
2623190|NCT01932437|Primary|Number of Participants Who Experienced Adverse Events|Safety was assessed for all subjects in the Safety Population by collecting and monitoring vital signs, clinical laboratory tests, ECGs, physical examinations, injection site assessments, skin assessments for presence/absence of rash, and adverse events (AEs).|Up to 71 (+/- 4) days or for 30 additional days after the final study visit for subjects with ongoing adverse events at the final scheduled study visit, for each group.|All subjects who received either ETI-204 or placebo were included in the Safety Population. Placebo subject were included in each cohort (one in Cohort 1 and two each in Cohorts 2, 3 ,4 and 5). Safety data are summarized separately for subjects who received ETI-204 in each dose group and for the pooled placebo group.|||Participants|||Count of Participants
2623191|NCT01932294|Secondary|Number of Participants With Known Heart Transplantation|Heart transplantation after the baseline visit up to 24 months|6 month intervals after the baseline visit up to 24 months|Patients with known endpoints.|||Participants|||Count of Participants
2623192|NCT01932294|Secondary|Number of Participants With Known Ventricular Assist Device (VAD) Implantation|Known VAD implantation after the baseline visit up to 24 months|6 month intervals after the baseline visit up to 24 months|Patients with known endpoints.|||Participants|||Count of Participants
2623193|NCT01932294|Primary|Number of Heart Failure Participants Deceased at 24 Months|Death after the baseline visit up to 24 months|6 month intervals after the baseline visit up to 24 months|By the end of the follow-up, 43 patients had deceased.|||Participants|||Count of Participants
2623194|NCT01932242|Secondary|Number of Participants With Anti-ETI-204 Antibodies|Serum anti-ETI-204 antibody titers were determined for all subjects in the safety population. Blood samples were collected and serum samples were assayed at an initial dilution of 1:10. Samples that were positive at the 1:10 dilution were serially diluted 1:2 and assayed until a negative result was attained. The titer of the most dilute sample yielding a positive result was recorded as the titer for that time point. Immunogenicity was measured by the number of participants in each study arm with anti-ETI-204 antibody values post-treatment ≥ 4-times higher than baseline at Day 8, 43 or 71, or if the titer was negative at baseline, the post-treatment sample(s) required a titer of at least 1:20 for it to be considered positive.|On Days 1,14, and 120 predose and on Days 8, 43, 85, 128, 163, and 191||||Participants|||Count of Participants
2623221|NCT01931956|Other Pre-specified|Change in 6-Minute Walk Test (6MWT)|Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes.|At Baseline and 6 months|"EU and CU arm participants were not analyzed due to serious/life-threatening conditions, the 6MWT was not administered to all patients at baseline.Therefore, paired data at 6 months were not available for EU and CU arm.~The number of participants analyzed includes subjects who had available follow up data at that time frame HR and Non-HR arms."|||Meters||Standard Deviation|Mean
2623252|NCT01931956|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 24 months as determined by echo core laboratory.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623195|NCT01932242|Secondary|Volume of Distribution at Steady State (Vdss) After a Dose of 16 mg/kg ETI-204 on Day 120 (Sequence B)|"Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.~Sequence A - there were insufficient serum concentration data to adequately characterize ETI 204 PK separately after each dose administration (Day 1 and Day 14), therefore it was treated as one 32 mg/kg dose split into two 16 mg/kg administrations. Sequence B was treated as 2 separate 16 mg/kg doses (Day 1 and Day 120). All 70 subjects who received ETI-204 were included in the PK population: 35 in Sequence A and 35 in Sequence B; however, the full complement of PK parameters could not be determined in all subjects."|On Day 120 predose, at the end of infusion, and 3 and 8 hours after the start of infusion, and on Days 2, 8, 15, 28, 43, 71, 85, 121, 128, 134, 149, 163, and 191.|4 subjects in Sequence B were excluded because they did not receive the 2nd dose of ETI-204 on Day 120. For 4 subjects in Sequence B the AUC and lambda z-based parameters were excluded from descriptive statistics for Day 120 (1 for missing the final 3 or more scheduled samples, 3 because the t1/2 values were >50% of the sample collection interval).|||Liters||Standard Deviation|Mean
2623196|NCT01932242|Secondary|Volume of Distribution at Steady State (Vdss) After a Dose of 16 mg/kg ETI-204 on Day 1 (Sequence B)|"Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.~Sequence A - there were insufficient serum concentration data to adequately characterize ETI 204 PK separately after each dose administration (Day 1 and Day 14), therefore it was treated as one 32 mg/kg dose split into two 16 mg/kg administrations. Sequence B was treated as 2 separate 16 mg/kg doses (Day 1 and Day 120). All 70 subjects who received ETI-204 were included in the PK population: 35 in Sequence A and 35 in Sequence B; however, the full complement of PK parameters could not be determined in all subjects."|On Day 1 predose, at the end of infusion, and 3 and 8 hours after the start of infusion, and on Days 2, 8, 15, 28, 43, 71, 85, 121, 128, 134, 149, 163, and 191.|One subject in Sequence B was missing the final 3 or more scheduled samples and therefore AUC and lambda z-based parameters were not reported. Vdss was not reported for Sequence A.|||Liters||Standard Deviation|Mean
2623197|NCT01932242|Secondary|Volume of Distribution (Vd) After a Dose of 16 mg/kg ETI-204 on Day 120 (Sequence B)|"Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.~Sequence A - there were insufficient serum concentration data to adequately characterize ETI 204 PK separately after each dose administration (Day 1 and Day 14), therefore it was treated as one 32 mg/kg dose split into two 16 mg/kg administrations. Sequence B was treated as 2 separate 16 mg/kg doses (Day 1 and Day 120). All 70 subjects who received ETI-204 were included in the PK population: 35 in Sequence A and 35 in Sequence B; however, the full complement of PK parameters could not be determined in all subjects."|On Day 120 predose, at the end of infusion, and 3 and 8 hours after the start of infusion, and on Days 2, 8, 15, 28, 43, 71, 85, 121, 128, 134, 149, 163, and 191.|4 subjects in Sequence B were excluded because they did not receive the 2nd dose of ETI-204 on Day 120. For 4 subjects in Sequence B the AUC and lambda z-based parameters were excluded from descriptive statistics for Day 120 (1 for missing the final 3 or more scheduled samples, 3 because the t1/2 values were >50% of the sample collection interval).|||Liters||Standard Deviation|Mean
2623198|NCT01932242|Secondary|Volume of Distribution (Vd) After a Dose of 16 mg/kg ETI-204 on Day 1 (Sequence B) or Two Doses on Days 1 and 14 (Sequence A)|"Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.~Sequence A - there were insufficient serum concentration data to adequately characterize ETI 204 PK separately after each dose administration (Day 1 and Day 14), therefore it was treated as one 32 mg/kg dose split into two 16 mg/kg administrations. Sequence B was treated as 2 separate 16 mg/kg doses (Day 1 and Day 120). All 70 subjects who received ETI-204 were included in the PK population: 35 in Sequence A and 35 in Sequence B; however, the full complement of PK parameters could not be determined in all subjects."|On Days 1 and 14 predose, at the end of infusion, and 3 and 8 hours after the start of infusion, and on Days 2, 8, 15, 28, 43, 71, 85, 121, 128, 134, 149, 163, and 191.|PK parameters for 1 subject in Sequence A were excluded because the subject was discontinued after the 1st dose of ETI-204 because of AEs and did not receive the 2nd dose. 2 subjects in Sequence A and 1 subject in Sequence B were missing the final 3 or more scheduled samples and therefore AUC and lambda z-based parameters were not reported.|||Liters||Standard Deviation|Mean
2623199|NCT01932242|Secondary|Systemic Clearance (CL) After a Dose of 16 mg/kg ETI-204 on Day 120 (Sequence B)|"Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.~Sequence A - there were insufficient serum concentration data to adequately characterize ETI 204 PK separately after each dose administration (Day 1 and Day 14), therefore it was treated as one 32 mg/kg dose split into two 16 mg/kg administrations. Sequence B was treated as 2 separate 16 mg/kg doses (Day 1 and Day 120). All 70 subjects who received ETI-204 were included in the PK population: 35 in Sequence A and 35 in Sequence B; however, the full complement of PK parameters could not be determined in all subjects."|On Day 120 predose, at the end of infusion, and 3 and 8 hours after the start of infusion, and on Days 2, 8, 15, 28, 43, 71, 85, 121, 128, 134, 149, 163, and 191.|4 subjects in Sequence B were excluded because they did not receive the 2nd dose of ETI-204 on Day 120. For 4 subjects in Sequence B the AUC and lambda z-based parameters were excluded from descriptive statistics for Day 120 (1 for missing the final 3 or more scheduled samples, 3 because the t1/2 values were >50% of the sample collection interval).|||Liters/day||Standard Deviation|Mean
2623222|NCT01931956|Other Pre-specified|Change in 6-Minute Walk Test (6MWT)|Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes.|At Baseline and 30 Days|"EU arm participants were not analyzed due to serious/life-threatening conditions, the 6MWT was not administered to all patients at baseline.Therefore,paired data at 30 days were not available for EU arm.~The number of participants analyzed includes subjects who had available follow up data at that time frame in CU, HR and Non-HR arms."|||Meters||Standard Deviation|Mean
2623235|NCT01931956|Secondary|Septal-Lateral Annular Dimension Diastole (SLADd)|Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 12 months as determined by echo core laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623200|NCT01932242|Secondary|Systemic Clearance (CL) After a Dose of 16 mg/kg ETI-204 on Day 1 (Sequence B) or Two Doses on Days 1 and 14 (Sequence A)|"Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.~Sequence A - there were insufficient serum concentration data to adequately characterize ETI 204 PK separately after each dose administration (Day 1 and Day 14), therefore it was treated as one 32 mg/kg dose split into two 16 mg/kg administrations. Sequence B was treated as 2 separate 16 mg/kg doses (Day 1 and Day 120). All 70 subjects who received ETI-204 were included in the PK population: 35 in Sequence A and 35 in Sequence B; however, the full complement of PK parameters could not be determined in all subjects."|On Days 1 and 14 predose, at the end of infusion, and 3 and 8 hours after the start of infusion, and on Days 2, 8, 15, 28, 43, 71, 85, 121, 128, 134, 149, 163, and 191.|PK parameters for 1 subject in Sequence A were excluded because the subject was discontinued after the1st dose of ETI-204 because of AEs and did not receive the 2nd dose. 2 subjects in Sequence A and 1 subject in Sequence B were missing the final 3 or more scheduled samples and therefore AUC and lambda z-based parameters were not reported.|||Liters/day||Standard Deviation|Mean
2623201|NCT01932242|Secondary|Terminal Half-life (t1/2) After a Dose of 16 mg/kg ETI-204 on Day 120 (Sequence B)|Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.The PK parameter, Cmax, was derived from ETI-204 serum concentrations by sequence group and treatment period for the PK analysis population. Sequence A - there were insufficient serum concentration data to adequately characterize ETI 204 PK separately after each dose administration (Day 1 and Day 14), therefore it was treated as one 32 mg/kg dose split into two 16 mg/kg administrations. Sequence B was treated as 2 separate 16 mg/kg doses (Day 1 and Day 120). All 70 subjects who received ETI-204 were included in the PK population: 35 in Sequence A and 35 in Sequence B; however, the full complement of PK parameters could not be determined in all subjects.|On Day 120 predose, at the end of infusion, and 3 and 8 hours after the start of infusion, and on Days 2, 8, 15, 28, 43, 71, 85, 121, 128, 134, 149, 163, and 191.|4 subjects in Sequence B were excluded because they did not receive the 2nd dose of ETI-204 on Day 120. For 4 subjects in Sequence B the AUC and lambda z-based parameters were excluded from descriptive statistics for Day 120 (1 for missing the final 3 or more scheduled samples, 3 because the t1/2 values were >50% of the sample collection interval).|||days||Standard Deviation|Mean
2623202|NCT01932242|Secondary|Terminal Half-life (t1/2) After a Dose of 16 mg/kg ETI-204 on Day 1 (Sequence B) or Two Doses on Days 1 and 14 (Sequence A)|"Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.~Sequence A - there were insufficient serum concentration data to adequately characterize ETI 204 PK separately after each dose administration (Day 1 and Day 14), therefore it was treated as one 32 mg/kg dose split into two 16 mg/kg administrations. Sequence B was treated as 2 separate 16 mg/kg doses (Day 1 and Day 120). All 70 subjects who received ETI-204 were included in the PK population: 35 in Sequence A and 35 in Sequence B; however, the full complement of PK parameters could not be determined in all subjects."|On Days 1 and 14 predose, at the end of infusion, and 3 and 8 hours after the start of infusion, and on Days 2, 8, 15, 28, 43, 71, 85, 121, 128, 134, 149, 163, and 191.|PK parameters for 1 subject in Sequence A were excluded because the subject was discontinued after the 1st dose of ETI-204 because of AEs and did not receive the 2nd dose. 2 subjects in Sequence A and 1 subject in Sequence B were missing the final 3 or more scheduled samples and therefore AUC and lambda z-based parameters were not reported.|||days||Standard Deviation|Mean
2623203|NCT01932242|Secondary|Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) After a Dose of 16 mg/kg ETI-204 on Day 120 (Sequence B)|"Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.~Sequence A - there were insufficient serum concentration data to adequately characterize ETI 204 PK separately after each dose administration (Day 1 and Day 14), therefore it was treated as one 32 mg/kg dose split into two 16 mg/kg administrations. Sequence B was treated as 2 separate 16 mg/kg doses (Day 1 and Day 120). All 70 subjects who received ETI-204 were included in the PK population: 35 in Sequence A and 35 in Sequence B; however, the full complement of PK parameters could not be determined in all subjects."|On Day 120 prepose, at the end of infusion, and 3 and 8 hours after the start of infusion, and on Days 2, 8, 15, 28, 43, 71, 85, 121, 128, 134, 149, 163, and 191.|4 subjects in Sequence B were excluded because they did not receive the 2nd dose of ETI-204 on Day 120. For 4 subjects in Sequence B the AUC and lambda z-based parameters were excluded from descriptive statistics for Day 120 (1 for missing the final 3 or more scheduled samples, 3 because the t1/2 values were >50% of the sample collection interval).|||µg.day/mL||Standard Deviation|Mean
2623204|NCT01932242|Secondary|Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) After a Dose of 16 mg/kg ETI-204 on Day 1 (Sequence B) or Two Doses on Days 1 and 14 (Sequence A)|"Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.~Sequence A - there were insufficient serum concentration data to adequately characterize ETI 204 PK separately after each dose administration (Day 1 and Day 14), therefore it was treated as one 32 mg/kg dose split into two 16 mg/kg administrations. Sequence B was treated as 2 separate 16 mg/kg doses (Day 1 and Day 120). All 70 subjects who received ETI-204 were included in the PK population: 35 in Sequence A and 35 in Sequence B; however, the full complement of PK parameters could not be determined in all subjects."|On Days 1 and 14 predose, at the end of infusion, and 3 and 8 hours after the start of infusion, and on Days 2, 8, 15, 28, 43, 71, 85, 121, 128, 134, 149, 163, and 191.|PK parameters for 1 subject in Sequence A were excluded because the subject was discontinued after the 1st dose of ETI-204 because of AEs and did not receive the 2nd dose. 2 subjects in Sequence A and 1 subject in Sequence B were missing the final 3 or more scheduled samples and therefore AUC and lambda z-based parameters were not reported.|||µg.day/mL||Standard Deviation|Mean
2623232|NCT01931956|Secondary|Septal-Lateral Annular Dimension Diastole (SLADd)|Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 48 months as determined by echo core laboratory.|48 months|For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623205|NCT01932242|Secondary|Area Under the Concentration-Time Curve From Time Zero to 120 Days (AUC0-120days) After a Dose of 16 mg/kg ETI-204 on Day 1 (Sequence B)|"Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.~Sequence A - there were insufficient serum concentration data to adequately characterize ETI 204 PK separately after each dose administration (Day 1 and Day 14), therefore it was treated as one 32 mg/kg dose split into two 16 mg/kg administrations. Sequence B was treated as 2 separate 16 mg/kg doses (Day 1 and Day 120). All 70 subjects who received ETI-204 were included in the PK population: 35 in Sequence A and 35 in Sequence B; however, the full complement of PK parameters could not be determined in all subjects."|On Day 1 predose, at the end of infusion, and 3 and 8 hours after the start of infusion, and on Days 2, 8, 15, 28, 43, 71, 85, 121, 128, 134, 149, 163, and 191.|One subjects in Sequence B was missing the final 3 or more scheduled samples (subject withdrew from the study on Day 8 due to conflict with work schedule) and therefore AUC and lamda z-based parameters were not reported. AUC0-120days was not calculated for Sequence A.|||µg.day/mL||Standard Deviation|Mean
2623206|NCT01932242|Secondary|Area Under the Concentration-Time Curve From Time Zero to 191 Days (AUC0-191days) After a Dose of 16 mg/kg ETI-204 on Days 1 and 14 (Sequence A)|"Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.~Sequence A - there were insufficient serum concentration data to adequately characterize ETI 204 PK separately after each dose administration (Day 1 and Day 14), therefore it was treated as one 32 mg/kg dose split into two 16 mg/kg administrations. Sequence B was treated as 2 separate 16 mg/kg doses (Day 1 and Day 120). All 70 subjects who received ETI-204 were included in the PK population: 35 in Sequence A and 35 in Sequence B; however, the full complement of PK parameters could not be determined in all subjects."|On Days 1 and 14 predose, at the end of infusion, and 3 and 8 hours after the start of infusion, and on Days 2, 8, 15, 28, 43, 71, 85, 121, 128, 134, 149, 163, and 191.|PK parameters for 1 subject in Sequence A were excluded because the subject did not rec a 2nd dose of ETI-204 due to AEs after the 1st dose. 2 subjects in Sequence A were missing the final 3 or more scheduled samples and therefore AUC and lambda z-based parameters were not reported. AUC0-191days was not calculated for Sequence B.|||µg.day/mL||Standard Deviation|Mean
2623207|NCT01932242|Secondary|Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last) After a Dose of 16 mg/kg ETI-204 on Day 120 (Sequence B)|"Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.~Sequence A - there were insufficient serum concentration data to adequately characterize ETI 204 PK separately after each dose administration (Day 1 and Day 14), therefore it was treated as one 32 mg/kg dose split into two 16 mg/kg administrations. Sequence B was treated as 2 separate 16 mg/kg doses (Day 1 and Day 120). All 70 subjects who received ETI-204 were included in the PK population: 35 in Sequence A and 35 in Sequence B; however, the full complement of PK parameters could not be determined in all subjects."|On Day 120 predose, at the end of infusion, and 3 and 8 hours after the start of infusion, and on Days 2, 8, 15, 28, 43, 71, 85, 121, 128, 134, 149, 163, and 191.|4 subjects in Sequence B were excluded because the subjects did not receive the 2nd dose of ETI-204 on Day 120 (1 due to AEs after 1st dose, 1 withdrew consent , 1 lost to follow-up, 1 protocol violation). 1 subjects in Sequence B was missing the final 3 or more scheduled samples and therefore AUC and lambda z-based parameters were not reported.|||µg.day/mL||Standard Deviation|Mean
2623208|NCT01932242|Secondary|Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last) After a Dose of 16 mg/kg ETI-204 on Day 1 (Sequence B) or Two Doses on Days 1 and 14 (Sequence A)|"Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.~Sequence A - there were insufficient serum concentration data to adequately characterize ETI 204 PK separately after each dose administration (Day 1 and Day 14), therefore it was treated as one 32 mg/kg dose split into two 16 mg/kg administrations. Sequence B was treated as 2 separate 16 mg/kg doses (Day 1 and Day 120). All 70 subjects who received ETI-204 were included in the PK population: 35 in Sequence A and 35 in Sequence B; however, the full complement of PK parameters could not be determined in all subjects."|On Days 1 and 14 predose, at the end of infusion, and 3 and 8 hours after the start of infusion, and on Days 2, 8, 15, 28, 43, 71, 85, 121, 128, 134, 149, 163, and 191.|PK parameters for 1 subject in Sequence A were excluded because the subject was discontinued after the 1st dose of ETI-204 because of AEs and did not receive the 2nd dose. 2 subjects in Sequence A and 1 subject in Sequence B (Day 1) were missing the final 3 or more scheduled samples and therefore AUC and lambda z-based parameters were not reported.|||µg.day/mL||Standard Deviation|Mean
2623209|NCT01932242|Secondary|Time to Maximum Observed Plasma Concentration of ETI-204 (Tmax) After a Dose of 16 mg/kg on Day 120 (Sequence B)|"Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.~Sequence A - there were insufficient serum concentration data to adequately characterize ETI 204 PK separately after each dose administration (Day 1 and Day 14), therefore it was treated as one 32 mg/kg dose split into two 16 mg/kg administrations. Sequence B was treated as 2 separate 16 mg/kg doses (Day 1 and Day 120). All 70 subjects who received ETI-204 were included in the PK population: 35 in Sequence A and 35 in Sequence B; however, the full complement of PK parameters could not be determined in all subjects."|On Day 120 predose, at the end of infusion, and 3 and 8 hours after the start of infusion, and on Days 2, 8, 15, 28, 43, 71, 85, 121, 128, 134, 149, 163, and 191.|Four subjects in Sequence B were excluded because the subjects did not receive the 2nd dose of ETI-204 16 m/kg on Day 120 (one due to AEs after the 1st dose, one withdrew consent due to conflict with work, one was lost to follow-up on Day 43, and one was withdrawn by the investigator due to protocol violation (positive drug screen on Day 120).|||days||Full Range|Median
2623233|NCT01931956|Secondary|Septal-Lateral Annular Dimension Diastole (SLADd)|Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 36 months as determined by echo core laboratory.|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623574|NCT01929408|Secondary|Percentage Analyzed Participants Without HCT and Deceased|Percentage analyzed participants without HCT and Deceased|1 year after starting induction||||% participants|||Number
2623210|NCT01932242|Secondary|Time to Maximum Observed Plasma Concentration of ETI-204 (Tmax) After a Dose of 16 mg/kg on Day 1(Sequence B) or Two Doses on Days 1 and 14 (Sequence A)|Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.The PK parameter, Tmax, was derived from ETI-204 serum concentrations by sequence group and treatment period for the PK analysis population. Sequence A - there were insufficient serum concentration data to adequately characterize ETI 204 PK separately after each dose administration (Day 1 and Day 14), therefore it was treated as one 32 mg/kg dose split into two 16 mg/kg administrations. Sequence B was treated as 2 separate 16 mg/kg doses (Day 1 and Day 120). All 70 subjects who received ETI-204 were included in the PK population: 35 in Sequence A and 35 in Sequence B; however, the full complement of PK parameters could not be determined in all subjects.|On Days 1 and 14 predose, at the end of infusion, and 3 and 8 hours after the start of infusion, and on Days 2, 8, 15, 28, 43, 71, 85, 121, 128, 134, 149, 163, and 191.|One subject in Sequence A was prematurely discontinued from the study by the investigator afte the 1st dose of ETI-204 because of AEs. This subject did not receive the 2nd dose of ETI-204 on Day 14 and therefore all PK parameters from this subject were excluded from descriptive statistics.|||days||Full Range|Median
2623211|NCT01932242|Secondary|Maximum Observed Plasma Concentration of ETI-204 (Cmax) After a Dose of 16 mg/kg on Day 120 (Sequence B)|"Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.~Sequence A - there were insufficient serum concentration data to adequately characterize ETI 204 PK separately after each dose administration (Day 1 and Day 14), therefore it was treated as one 32 mg/kg dose split into two 16 mg/kg administrations. Sequence B was treated as 2 separate 16 mg/kg doses (Day 1 and Day 120). All 70 subjects who received ETI-204 were included in the PK population: 35 in Sequence A and 35 in Sequence B; however, the full complement of PK parameters could not be determined in all subjects."|On Day 120 predose, at the end of infusion, and 3 and 8 hours after the start of infusion, and on Days 2, 8, 15, 28, 43, 71, 85, 121, 128, 134, 149, 163, and 191.|Four subjects in Sequence B were excluded because the subjects did not receive the 2nd dose of ETI-204 16 m/kg on Day 120 (one due to AEs after the 1st dose, one withdrew consent due to conflict with work, one was lost to follow-up on Day 43, and one was withdrawn by the investigator due to protocol violation (positive drug screen on Day 120).|||µg/mL||Standard Deviation|Mean
2623212|NCT01932242|Secondary|Maximum Observed Plasma Concentration of ETI-204 (Cmax) After a Dose of 16 mg/kg on Day 1(Sequence B) or Two Doses on Days 1 and 14 (Sequence A)|"Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.The PK parameter, Cmax, was derived from ETI-204 serum concentrations by sequence group and treatment period for the PK analysis population.~Sequence A - there were insufficient serum concentration data to adequately characterize ETI 204 PK separately after each dose administration (Day 1 and Day 14), therefore it was treated as one 32 mg/kg dose split into two 16 mg/kg administrations. Sequence B was treated as 2 separate 16 mg/kg doses (Day 1 and Day 120).~All 70 subjects who received ETI-204 were included in the PK population: 35 in Sequence A and 35 in Sequence B; however, the full complement of PK parameters could not be determined in all subjects."|On Days 1 and 14 predose, at the end of infusion, and 3 and 8 hours after the start of infusion, and on Days 2, 8, 15, 28, 43, 71, 85, 121, 128, 134, 149, 163, and 191.|One subject in Sequence A was prematurely discontinued from the study by the investigator after the 1st dose of ETI-204 because of AEs. This subject did not receive the 2nd dose of ETI-204 on Day 14 and therefore all PK parameters from this subject were excluded from descriptive statistics.|||µg/mL||Standard Deviation|Mean
2623213|NCT01932242|Primary|Number of Participants Who Experienced Adverse Events|Safety was assessed for all subjects in the safety population by collecting and monitoring vital signs, laboratory tests, ECGs, physical examinations, skin assessments, infusion site assessments and adverse events.|Up to 191 days or 221 days (30 days after the final study visit) for subjects with ongoing adverse events at the final study visit, for each arm.|The safety population consisted of all subjects who received at least a partial dose of ETI 204 or placebo, whether prematurely withdrawn from the study or not|||Participants|||Count of Participants
2623214|NCT01932164|Primary|Quality of Bone Regeneration|The quality of bone formation will be conducted by analysis of CT scans of alveolar cleft area through canine tooth eruption in these position of new bone formation by tissue engineering techniques. We are waiting the canine eruption at the mouth.|Three months after the graft||||percentage of bone filling||80% Confidence Interval|Mean
2623215|NCT01932164|Primary|Amount of New Bone Mass Formed|The quantification of bone formation will be conducted by analysis of CT scans of alveolar cleft area that receive autogenous mesenchymal stem cells from dental pulp associated with the biomaterial 3 and 6 months after surgical procedure ( tissue engineering ) in comparison with CT Scan previously of tissue engineering surgery.Preoperative and follow-up examinations reveled progressive alveolar bone union in all patients. For these 5 patients final completion of the alveolar defect with an 89,5% mean bone height was detected 6 months postoperatively. We are still waiting the canine dental eruption at the new bone. For these group of patients the bone tissue engineering using autologous mesenchymal stem cells associated with biomaterial resulted in satisfactory bone healing.|6 months from surgical procedure for alveolar grafting;|3 females and 2 males with cleft lip and palate|||percentage of bone formation||95% Confidence Interval|Mean
2623216|NCT01932112|Secondary|Atrial Fibrillation Recurrence|At 1 month, 3 month, 6 month and 12 months post ablation routine clinic visits, will perform electrocardiographically documented by electrogram (At 1,3,6,12 months post ablation) and Holter monitoring (At 12 months post ablation)|between 0 and 12 months|||||||
2623217|NCT01932112|Primary|Reconnection of Pulmonary Vein Electrogram After Adenosine Infusion|After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.|5 minutes after IV adenosine||||participants|||Number
2623218|NCT01932060|Secondary|Hemoglobin Indices After Cesarean Delivery|Study investigators will assess maternal hemoglobin levels at 24hr after cesarean delivery|24 hr after cesarean delivery||||g/dl||Inter-Quartile Range|Median
2623219|NCT01932060|Primary|Total Estimated Blood Loss|Blood loss will be measured volumetrically (based on measured volume of blood within the suction chamber) and gravimetrically (based on blood weight on blood soaked laps).|immediately at end of surgery||||ml||Inter-Quartile Range|Median
2623223|NCT01931956|Other Pre-specified|36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 12 Months|"The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts:~Physical functioning~Role limitations due to physical or~Emotional health~Bodily pain~General health perceptions~Vitality~Social functioning~General mental health~Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.~The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively."|12 months|"EU arm participants were not analyzed due to the serious/life-threatening conditions, QOL data was not collected on all patients at baseline. Therefore, paired data at 1 year were not available for EU arm.~The number of participants analyzed includes subjects who had available follow up data at that time frame."|||Scores on a scale||Standard Deviation|Mean
2623224|NCT01931956|Other Pre-specified|36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 30 Days|"The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts:~Physical functioning~Role limitations due to physical or~Emotional health~Bodily pain~General health perceptions~Vitality~Social functioning~General mental health~Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health.~The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively."|30 days|"EU arm participants were not analyzed due to the serious/life-threatening conditions,SF-36 QOL data was not collected on all patients at baseline. Therefore, paired data at 30 days were not available for EU arm.~The number of participants analyzed includes subjects who had available follow up data at that time frame."|||Scores on a scale||Standard Deviation|Mean
2623225|NCT01931956|Secondary|Septal-Lateral Annular Dimension Systole (SLADs)|Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 60 months as determined by echo core laboratory.|60 months|For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623226|NCT01931956|Secondary|Septal-Lateral Annular Dimension Systole (SLADs)|Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 48 months as determined by echo core laboratory.|48 months|For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623227|NCT01931956|Secondary|Septal-Lateral Annular Dimension Systole (SLADs)|Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 36 months as determined by echo core laboratory.|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623228|NCT01931956|Secondary|Septal-Lateral Annular Dimension Systole (SLADs)|Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 24 months as determined by echo core laboratory.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623229|NCT01931956|Secondary|Septal-Lateral Annular Dimension Systole (SLADs)|Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 12 months as determined by echo core laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623230|NCT01931956|Secondary|Septal-Lateral Annular Dimension Systole (SLADs)|Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to discharge or 30 days as determined by echo core laboratory.|At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623231|NCT01931956|Secondary|Septal-Lateral Annular Dimension Diastole (SLADd)|Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 60 months as determined by echo core laboratory.|60 months|For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623234|NCT01931956|Secondary|Septal-Lateral Annular Dimension Diastole (SLADd)|Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 24 months as determined by echo core laboratory.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623236|NCT01931956|Secondary|Septal-Lateral Annular Dimension Diastole (SLADd)|Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to discharge or 30 days as determined by echo core laboratory.|At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623237|NCT01931956|Secondary|Left Ventricular Ejection Fraction (LVEF)|Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 60 months as determined by echo core laboratory.|60 months|For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
2623238|NCT01931956|Secondary|Left Ventricular Ejection Fraction (LVEF)|Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 48 months as determined by echo core laboratory.|48 months|For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
2623239|NCT01931956|Secondary|Left Ventricular Ejection Fraction (LVEF)|Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 36 months as determined by echo core laboratory.|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
2623240|NCT01931956|Secondary|Left Ventricular Ejection Fraction (LVEF)|Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 24 months as determined by echo core laboratory.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
2623241|NCT01931956|Secondary|Left Ventricular Ejection Fraction (LVEF)|Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 12 months as determined by echo core laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
2623242|NCT01931956|Secondary|Left Ventricular Ejection Fraction (LVEF)|Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to discharge or 30 days as determined by echo core laboratory.|At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percentage of ejection fraction||Standard Deviation|Mean
2623243|NCT01931956|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 60 months as determined by echo core laboratory.|60 months|For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623244|NCT01931956|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 48 months as determined by echo core laboratory.|48 months|For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623245|NCT01931956|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 36 months as determined by echo core laboratory.|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623246|NCT01931956|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 24 months as determined by echo core laboratory.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623247|NCT01931956|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 12 months as determined by echo core laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623248|NCT01931956|Secondary|Left Ventricular Internal Dimension Systole (LVIDs)|Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to discharge or 30 days as determined by echo core laboratory.|At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623249|NCT01931956|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 60 months as determined by echo core laboratory.|60 months|For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623250|NCT01931956|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 48 months as determined by echo core laboratory.|48 months|For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623251|NCT01931956|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 36 months as determined by echo core laboratory.|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623575|NCT01929408|Primary|Percentage Analyzed Participants Receiving Hematopoietic Stem Cell Transplantation (HCT)|Percentage analyzed participants receiving HCT|1 year after starting induction||||% participants|||Number
2623253|NCT01931956|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 12 months as determined by echo core laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623254|NCT01931956|Secondary|Left Ventricular Internal Dimension Diastole (LVIDd)|Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to discharge or 30 days as determined by echo core laboratory.|At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||cm||Standard Deviation|Mean
2623255|NCT01931956|Secondary|Left Ventricular End-systolic Volume (LVESV)|Paired Left ventricular end-systolic volume (LVESV) data from baseline to 60 months as determined by echo core laboratory.|60 months|For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2623256|NCT01931956|Secondary|Left Ventricular End-systolic Volume (LVESV)|Paired Left ventricular end-systolic volume (LVESV) data from baseline to 48 months as determined by echo core laboratory.|48 months|For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2623257|NCT01931956|Secondary|Left Ventricular End-systolic Volume (LVESV)|Paired Left ventricular end-systolic volume (LVESV) data from baseline to 36 months as determined by echo core laboratory.|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2623258|NCT01931956|Secondary|Left Ventricular End-systolic Volume (LVESV)|Paired Left ventricular end-systolic volume (LVESV) data from baseline to 24 months as determined by echo core laboratory.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2623259|NCT01931956|Secondary|Left Ventricular End-systolic Volume (LVESV)|Paired Left ventricular end-systolic volume (LVESV) data from baseline to 12 months as determined by echo core laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2623260|NCT01931956|Secondary|Left Ventricular End-systolic Volume (LVESV)|Paired Left ventricular end-systolic volume (LVESV) data from baseline to discharge or 30 days as determined by echo core laboratory.|At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2623261|NCT01931956|Secondary|Left Ventricular End-diastolic Volume (LVEDV)|Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 60 months as determined by echo core laboratory.|60 months|For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2623262|NCT01931956|Secondary|Left Ventricular End-diastolic Volume (LVEDV)|Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 48 months as determined by the echo core laboratory.|48 months|For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2623263|NCT01931956|Secondary|Left Ventricular End-diastolic Volume (LVEDV)|Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 36 months as determined by echo core laboratory.|36 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2623264|NCT01931956|Secondary|Left Ventricular End-diastolic Volume (LVEDV)|Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 24 months as determined by echo core laboratory.|24 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2623265|NCT01931956|Secondary|Left Ventricular End-diastolic Volume (LVEDV)|Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 12 months as determined by echo core laboratory.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2623266|NCT01931956|Secondary|Left Ventricular End-diastolic Volume (LVEDV)|Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to discharge or 30 days as determined by echo core laboratory.|At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||ml||Standard Deviation|Mean
2623267|NCT01931956|Secondary|Number of Participants With NYHA Functional Class|"Paired NYHA data from baseline to 5 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2623277|NCT01931956|Secondary|Number of Participants With MR Severity|Paired site-assessed Mitral regurgitation severity between baseline and 3 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2623268|NCT01931956|Secondary|Number of Participants With NYHA Functional Class|"Paired NYHA data from baseline to 4 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|4 years|"The 4-year visit was optional and no data were collected at this time point for CU and EU arm.~The number of participants analyzed includes subjects who had available follow up data at that time frame in HR and Non-HR arm."|||Participants|||Count of Participants
2623269|NCT01931956|Secondary|Number of Participants With NYHA Functional Class|"Paired NYHA data from baseline to 3 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|3 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2623270|NCT01931956|Secondary|Number of Participants With NYHA Functional Class|"Paired NYHA data from baseline to 2 years. Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2623271|NCT01931956|Secondary|Number of Participants With NYHA Functional Class|"Paired NYHA data from baseline to 12 months. Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2623272|NCT01931956|Secondary|Number of Participants With New York Heart Association (NYHA) Functional Class|"Paired NYHA data from baseline to 30 days. Class I: Patients with cardiac disease but without resulting limitations of physical activity.~Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.~Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2623273|NCT01931956|Secondary|Number of Participants With Second Intervention to Place an Additional Mitraclip Device.|If residual MR was determined to be clinically unacceptable for patients who received only 1 clip during the index procedure, a second intervention to place an additional MitraClip device could be considered.|5 years|ITT population|||Participants|||Count of Participants
2623274|NCT01931956|Secondary|Number of Participants With Second Intervention to Place an Additional Mitraclip Device.|If residual MR was determined to be clinically unacceptable for patients who received only 1 clip during the index procedure, a second intervention to place an additional MitraClip device could be considered.|139 days post the index procedure|ITT population|||Participants|||Count of Participants
2623275|NCT01931956|Secondary|Number of Participants With MR Severity|Paired site-assessed Mitral regurgitation severity between baseline and 5 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.|5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2623276|NCT01931956|Secondary|Number of Participants With MR Severity|Paired site-assessed Mitral regurgitation severity between baseline and 4 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.|4 years|"The 4-year visit was optional and no data were collected at this time point for CU and EU arm.~The number of participants analyzed includes subjects who had available follow up data at that time frame in HR and Non-HR arm."|||Participants|||Count of Participants
2623703|NCT01928927|Secondary|Change in Inflammatory Cell Population Type and Number in Lymphoid Tissue Biopsy Specimens From Baseline to Week 48|Measured as the change from entry to week 48 in the frequency of CD14+, CD16+,CD64+, and/or CD163+ macrophages and % activated (CD38+/HLA-DR+, Ki67+) CD4 and CD8 T cells.|48 weeks||2019-01-31|01/2019||||
2623278|NCT01931956|Secondary|Number of Participants With MR Severity|Paired site-assessed Mitral regurgitation severity between baseline and 2 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.|2 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2623279|NCT01931956|Secondary|Number of Participants With MR Severity|Paired site-assessed Mitral regurgitation severity between baseline and 12 months using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2623280|NCT01931956|Secondary|Number of Participants With Mitral Regurgitation (MR) Severity|"Paired site-assessed Mitral regurgitation severity between baseline and 30 days using echocardiography.~MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe."|30 days(Follow-up)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2623281|NCT01931956|Secondary|Number of Participants With Mitral Stenosis|Mitral stenosis is a key safety consideration assessed after implantation of the MitraClip device. It is defined as Mitral Valve Area (MVA) less than 1.5 cm^2 as assessed by the Echocardiography Core Laboratory (ECL).|0 to 5 years|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2623282|NCT01931956|Secondary|Number of Participants With Device Embolization or Single Leaflet Device Attachment (SLDA)|A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.|0 to 5 years|ITT population|||Participants|||Count of Participants
2623283|NCT01931956|Secondary|Number of Participants With Hospital Re-admissions|Defined as re-admission of patients to the hospital following discharge from the Clip procedure.|30 days|ITT population|||Participants|||Count of Participants
2623284|NCT01931956|Secondary|Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility||At discharge (an average of ≤ 12.3 days post-index procedure)|ITT population|||Participants|||Count of Participants
2623285|NCT01931956|Secondary|Number of Participants Experiencing Death|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|12 months visit window (410 days)|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2623286|NCT01931956|Secondary|Post-Procedure Length of Hospital Stay|Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.|At discharge (an average of ≤ 12.3 days post-index procedure).|ITT population|||Days||Standard Deviation|Mean
2623287|NCT01931956|Secondary|Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU)/ Post-anesthesia Care Unit (PACU) Duration|Defined as the number of hours for which patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.|At discharge (an average of ≤ 12.3 days post-index procedure).|ITT population|||Hours||Standard Deviation|Mean
2623288|NCT01931956|Secondary|Number of Participants With MitraClip Devices Implanted|The distribution of number of MitraClip devices implanted in patients.|On the day of index procedure|ITT population|||Participants|||Count of Participants
2623289|NCT01931956|Secondary|Fluoroscopy Duration|Mean fluoroscopy duration during the MitraClip procedure.|On the day of index procedure|ITT population|||minutes||Standard Deviation|Mean
2623290|NCT01931956|Secondary|Device Time|Device time is defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip delivery catheter is retracted into the SGC.|On the day of index procedure|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||minutes||Standard Deviation|Mean
2623291|NCT01931956|Secondary|Procedure Time|The mean procedure time is defined as the start time of the transseptal procedure to the time the steerable guide catheter (SGC) is removed.|On the day of index procedure|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||minutes||Standard Deviation|Mean
2623292|NCT01931956|Secondary|Number of Participants With Clip Implant Rate|Defined as the procedural rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.|On the day of index procedure (≤1 day)|ITT population|||Participants|||Count of Participants
2623293|NCT01931956|Secondary|Number of Participants With Clinical Durability|Defined as the proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that at 12 months have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA at 12 months.|12 months|ITT population|||Participants|||Count of Participants
2623294|NCT01931956|Secondary|Number of Participants With Procedural Success|Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA at 30 days.|30 days|ITT population|||Participants|||Count of Participants
2623295|NCT01931956|Secondary|Number of Participants With Acute Procedural Success|Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ or less as determined by the echocardiographic assessment at discharge. The 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or uninterpretable, providing the patient has not undergone subsequent surgery after attempted clip.|At discharge (an average of ≤ 12.3 days post-index procedure)|ITT population|||Participants|||Count of Participants
2623296|NCT01931956|Secondary|Number of Participants With Major Adverse Events in Patients Over 75 Years of Age|MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.|5 years|"CU Arm:~There are 27 patients >75 years old in the CU arm. Safety data are available only for 24 patients.~EU Arm:~There are 5 patients >75 years old in the EU arm.~HR arm:~There are 393 patients >75 years old in the HR arm.~Non-HR arm:~There are 140 patients >75 years old in the Non-HR arm."|||Participants|||Count of Participants
2623297|NCT01931956|Secondary|Number of Participants With Major Adverse Events in Patients Over 75 Years of Age|MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.|4 years|"CU Arm:~There are 27 patients >75 years old in the CU arm. Safety data are available only for 24 patients.~EU Arm:~There are 5 patients >75 years old in the EU arm.~HR arm:~There are 393 patients >75 years old in the HR arm.~Non-HR arm:~There are 140 patients >75 years old in the Non-HR arm."|||Participants|||Count of Participants
2623298|NCT01931956|Secondary|Number of Participants With Major Adverse Events in Patients Over 75 Years of Age|MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.|3 years|"CU Arm:~There are 27 patients >75 years old in the CU arm. Safety data are available only for 26 patients.~EU Arm:~There are 5 patients >75 years old in the EU arm.~HR arm:~There are 393 patients >75 years old in the HR arm.~Non-HR arm:~There are 140 patients >75 years old in the Non-HR arm."|||Participants|||Count of Participants
2623299|NCT01931956|Secondary|Number of Participants With Major Adverse Events in Patients Over 75 Years of Age|MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.|2 years|"CU Arm:~There are 27 patients >75 years old in the CU arm. Safety data are available only for 26 patients.~EU Arm:~There are 5 patients >75 years old in the EU arm.~HR arm:~There are 393 patients >75 years old in the HR arm.~Non-HR arm:~There are 140 patients >75 years old in the Non-HR arm."|||Participants|||Count of Participants
2623300|NCT01931956|Secondary|Number of Participants With Major Adverse Events in Patients Over 75 Years of Age|MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.|12 Months|"CU Arm:~There are 27 patients >75 years old in the CU arm. Safety data are available only for 26 patients.~EU Arm:~There are 5 patients >75 years old in the EU arm.~HR arm:~There are 393 patients >75 years old in the HR arm.~Non-HR arm:~There are 140 patients >75 years old in the Non-HR arm."|||Participants|||Count of Participants
2623301|NCT01931956|Secondary|Number of Participants With Major Adverse Events (MAE) in Patients Over 75 Years of Age|MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.|30 days|"CU Arm:~There are 27 patients >75 years old in the CU arm. Safety data are available only for 26 patients.~EU Arm:~There are 5 patients >75 years old in the EU arm.~HR arm:~There are 393 patients >75 years old in the HR arm.~Non-HR arm:~There are 140 patients >75 years old in the Non-HR arm."|||Participants|||Count of Participants
2623302|NCT01931956|Secondary|Number of Participants With Clinically Significant Atrial Septal Defect (ASD)|Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.|12 months|ITT population|||Participants|||Count of Participants
2623303|NCT01931956|Secondary|Number of Participants With Clinically Significant Atrial Septal Defect (ASD)|Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.|30 days|ITT population|||Participants|||Count of Participants
2623304|NCT01931956|Secondary|Number of Participants With Serious Adverse Events|The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.|12 months|ITT population|||Participants|||Count of Participants
2623305|NCT01931956|Secondary|Number of Participants With Serious Adverse Events|The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.|30 days|ITT population|||participants|||Number
2623897|NCT01928186|Secondary|Percentage Change in K1 (Blood Flow Parameter) by FLT PET|Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed.|Baseline to up to 6 weeks||||% change||Full Range|Median
2623306|NCT01931956|Primary|Number of Participants With 12-Month Efficacy|Defined as freedom from: Surgery for Mitral Regurgitation (MR) or Valve Dysfunction, death, and MR > 2+ (moderate to severe (3+) or severe MR (4+)).|12 months|Analysis was performed in 52 participants out of 59 in CU arm, in 6 subjects out of 7 in EU arm, in 556 participants out of 628 participants and 248 out of 271 participants in non-HR arm were analyzed.|||Participants|||Count of Participants
2623307|NCT01931956|Primary|Number of Participants With Major Adverse Events|A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.|12 months|ITT population|||Participants|||Count of Participants
2623308|NCT01931956|Primary|Number of Participants With Major Adverse Events|A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastro-intestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.|30 days|Intent-To-Treat Population set (ITT)|||Participants|||Count of Participants
2623309|NCT01931878|Secondary|Number of Patients Whose Patient Global Impression of Change (PGIC) Moderately or Much Improved|"The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:~No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)improved~This outcome is number of patients who chose a 5 or above on the PGIC 6 weeks after treatment."|6 weeks||||participants|||Number
2623310|NCT01931878|Other Pre-specified|Patients With Pain on Visual Analog Scale <4|The Visual Analog Scale (VAS) consists of a line which represents the level of pain in 10 cms. The subject is required to make this line to show where your pain level is on this line (for example, at the 7cm mark). A higher score is associated with a higher level of pain. Number of patients showing a pain score of <4.|6 weeks||||participants|||Number
2623311|NCT01931878|Primary|Mean Total Restless Leg Syndrome Rating Scale Score|The Restless Legs Syndrome Rating Scale uses 10 questions, each scored 0-4, with higher scores representing more severe symptoms. Score ranges from 1-40. Scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40)|6 weeks|Total RLS scale score was compared between incoA injections and and saline group injections.|||units on a scale||Standard Deviation|Mean
2623312|NCT01931865|Other Pre-specified|Patients Improved in Patient Global Impression of Change (PGIC) Scale|The Patient Global Impression of Change questionaire asks patient level of satisfaction with current treatment (from very unsatisfactory to very satisfactory).|12 weeks|Advanced cancer patients|||participants|||Number
2623313|NCT01931865|Secondary|Patients Who Show Improvement in American Pain Association Questionnaire|This quality of life scale consists of 10 questions regarding how pain affects your quality of life.|12 weeks|Advanced cancer patients|||participants|||Number
2623314|NCT01931865|Primary|Number of Participants With a Significant Reduction in Pain|visual analogue scale (VAS), a line which represents the level of pain in 10cms and you will show where your pain is on this line (0 no pain, 10 worst pain). A significant reduction is 2 grades on the scale.|12 weeks||||participants|||Number
2623315|NCT01931839|Secondary|Part A Observation Cohort: Number of Participants With Serious Adverse Events (SAEs)|AE: as any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.|up to 2 years|Safety Set (study 105) included all participants who were enrolled in Part A Observation Cohort.|||participants|||Number
2623316|NCT01931839|Secondary|Part B Treatment Cohort: Percentage of Participants With Response Based on Relative Change in Percent Predicted FEV1 From Baseline|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). Percentage of participants with at least 5% relative change in percent predicted FEV1 from Baseline were reported. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (NCT01225211) for Arm 6 and 7. As per planned analysis, endpoint evaluation included subjects from the parent study VX09-809-102 as well.|Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60, 72 (Study 105)|FAS (Study 102) was used for Arm 6 and 7, and included all participants randomized in the cohort 4 of study 102 and dosed.|||percentage of participants||95% Confidence Interval|Number
2623317|NCT01931839|Secondary|Part A Treatment Cohort: Percentage of Participants With Response Based on Relative Change in Percent Predicted FEV1 From Baseline|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). Percentage of participants with at least 5% and 10% relative change in percent predicted FEV1 from baseline were reported. Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4. As per planned analysis, endpoint evaluation included subjects from the parent study VX12-809-103 and VX12-809-104 as well for cumulative study period.|Baseline (Study 103/104/105); Day 15, Week 8, 16, 24, 36, 48, 60, 72, 84, 96 (Study 105)|FAS (Study 103/104) was used for Arm 1 and 3, and included all participants randomized in the previous studies and dosed. FAS (Study 105) was used for Arm 2 and 4, and included all participants randomized in the Part A Treatment Cohort and dosed in current study 105.|||percentage of participants||95% Confidence Interval|Number
2623318|NCT01931839|Secondary|Part A Treatment Cohort: Percentage of Participants With at Least 1 Pulmonary Exacerbation|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. Analysis was performed for the Cumulative Study Period for Arm 1 and 3, and for the current study period (Study 105) for Arm 2 and 4. As per planned analysis, endpoint evaluation included subjects from the parent study VX12-809-103 and VX12-809-104 as well for cumulative study period.|Baseline (Study 103/104) up to Week 100 (Study 105) for Arm 1 and 3 (Cumulative study period); Baseline (Study 105) up to Week 100 (Study 105) for Arm 2 and 4 (current study period)|FAS (Study 103/104) was used for Arm 1 and 3, and included all participants randomized in the previous studies and dosed. FAS (Study 105) was used for Arm 2 and 4, and included all participants randomized in the Part A Treatment Cohort and dosed in current study 105.|||percentage of participants||95% Confidence Interval|Number
2623319|NCT01931839|Secondary|Part A Treatment Cohort: Time-to-First Pulmonary Exacerbation|Time-to-first pulmonary exacerbation was analyzed using the Kaplan-Meier estimates. Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. Analysis was performed for the Cumulative Study Period for Arm 1 and 3, and for the current study period (Study 105) for Arm 2 and 4. As per planned analysis, endpoint evaluation included subjects from the parent study VX12-809-103 and VX12-809-104 as well for cumulative study period.|Baseline (Study 103/104) up to Week 100 (Study 105) for Arm 1 and 3 (Cumulative study period); Baseline (Study 105) up to Week 100 (Study 105) for Arm 2 and 4 (current study period)|FAS (Study 103/104) was used for Arm 1 and 3, and included all participants randomized in the previous studies and dosed. FAS (Study 105) was used for Arm 2 and 4, and included all participants randomized in the Part A Treatment Cohort and dosed in current study 105.|||days||Inter-Quartile Range|Median
2623320|NCT01931839|Secondary|Part B Treatment Cohort: Absolute Change From Baseline in Body Weight at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (NCT01225211) for Arm 6 and 7.|Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60, 72 (Study 105)|FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||kg||Standard Deviation|Mean
2623321|NCT01931839|Secondary|Part A Treatment Cohort: Absolute Change From Baseline in Body Weight at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4.|Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60, 72 (Study 105)|FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||kilograms (kg)||Standard Deviation|Mean
2623322|NCT01931839|Secondary|Part A Treatment Cohort: Absolute Change From Baseline in BMI Z-score at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is with range from -infinity to +infinity; 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. BMI-for-age z-score was calculated by using centers for disease control and prevention (CDC) growth charts for the pediatric population. Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4.|Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60, 72 (Study 105)|FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||z-score||Standard Error|Least Squares Mean
2623323|NCT01931839|Secondary|Part B Treatment Cohort: Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 15, Week 8, 16, 24, 48 and 72|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (NCT01225211) for Arm 6 and 7.|Baseline (Study 102 Study), Day 15, Week 8, 16, 24, 48, 72 (Study 105)|FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2623324|NCT01931839|Secondary|Part A Treatment Cohort: Absolute Change From Baseline in Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Domain Score at Day 15, Week 8, 16, 24, 48 and 72|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4.|Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 48, 72 (Study 105)|FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||units on a scale||Standard Error|Least Squares Mean
2623449|NCT01930487|Secondary|Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - DM|change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
2623325|NCT01931839|Secondary|Part A Treatment Cohort: Number of Pulmonary Exacerbations Events Per Patient-Year|Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. The number of events per patient year were reported, where patient years = total number of days on study/336. Analysis includes all events in the Cumulative Study Period for Arm 1 and 3, and all events in the Current Study period (Study 105) for Arm 2 and 4. As per planned analysis, endpoint evaluation included subjects from the parent study VX12-809-103 and VX12-809-104 as well for cumulative study period.|Baseline (Study 103/104) up to Week 100 (Study 105) for Arm 1 and 3 (Cumulative study period); Baseline (Study 105) up to Week 100 (Study 105) for Arm 2 and 4 (current study period)|FAS (Study 103/104) was used for Arm 1 & 3, & included all participants randomized in previous studies & dosed. FAS (Study 105) was used for Arm 2 & 4, & included all participants randomized in Part A Treatment Cohort & dosed in current study 105. ‘Number Analyzed’=those participants who were evaluable at specified time points for each arm.|||events per patient year||95% Confidence Interval|Number
2623326|NCT01931839|Secondary|Part B Treatment Cohort: Absolute Change From Baseline in BMI at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|BMI = (Weight [in kg]) divided by (Stature [in meters]) ^2. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (NCT01225211) for Arm 6 and 7.|Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)|FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||kg/m^2||Standard Deviation|Mean
2623327|NCT01931839|Secondary|Part A Treatment Cohort: Absolute Change From Baseline in Body Mass Index (BMI) at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|BMI = (Weight in kilogram [kg]) divided by (Stature in meters [m]) ^2. Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4.|Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)|FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||Kilogram per square meter (kg/m^2)||Standard Error|Least Squares Mean
2623328|NCT01931839|Secondary|Part B Treatment Cohort: Relative Change From Baseline in Percent Predicted FEV1 at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (NCT01225211) for Arm 6 and 7.|Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)|FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||percent change||Standard Deviation|Mean
2623329|NCT01931839|Secondary|Part A Treatment Cohort: Relative Change From Baseline in Percent Predicted FEV1 at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4.|Baseline (Study 103/104/105), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)|FAS study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||percent change||Standard Error|Least Squares Mean
2623330|NCT01931839|Secondary|Part B Treatment Cohort: Absolute Change From Baseline in Percent Predicted FEV1 at Day 15, Week 8, 16, 24, 36, 48, 60 and 72|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Analysis was performed using baseline of Cohort 4 of previous study VX09-809-102 (NCT01225211) for Arm 6 and 7.|Baseline (Study 102), Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)|FAS (study 105) included all participants randomized in the Part B Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||percent predicted of FEV1||Standard Deviation|Mean
2623339|NCT01931735|Primary|WOMET Score|Western Ontario Meniscal Evaluation Tool (WOMET) is a standardized and validated survey used to evaluate the pain and function of patients with a degenerative meniscal tear. The survey consists of 16 questions regarding physical symptoms, sports/recreation/work/lifestyle, and emotions. Each question is answered via a visual analog scale (VAS) of 0-100mm for a total score of 1600, where higher numbers are worse. The score is then transformed into a percentage, where 0 is the worst pain and functioning and 100% is no pain and fully functioning.|two years post baseline|Randomize meniscectomy: 2 lost to follow-up. Randomized Lavage: 2 lost to follow-up. Standard of care meniscectomy pre-amendment: not in protocol to follow subjects 2 years post baseline. Standard of care meniscectomy post-amendment: 1 withdraw, 1 adverse event.|||units on a scale||Standard Deviation|Mean
2623450|NCT01930487|Secondary|Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - No DM|change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
2623331|NCT01931839|Secondary|Part A Treatment Cohort: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) At Day 15, Week 8, 16, 24, 36, 48, 60 and 72|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Analysis was performed using baseline of the previous study VX12-809-103 (NCT01807923) and Study VX12-809-104 (NCT01807949) for Arm 1 and 3. Analysis was performed using baseline of the current study VX12-809-105 (NCT01931839) for Arm 2 and 4.|Baseline (Study 103/104/105); Day 15, Week 8, 16, 24, 36, 48, 60 , 72 (Study 105)|Full Analysis Set (FAS) study 105 (NCT01931839) included all participants randomized in the Part A Treatment Cohort and dosed. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||percent predicted of FEV1||Standard Error|Least Squares Mean
2623332|NCT01931839|Primary|Part B Treatment Cohort: Number of Participants With Treatment-Emergent AEs and SAEs|AE: as any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or newly developed at or after initial dosing of study drug was considered treatment-emergent.|Day 1 up to Week 105 (Study 105)|Safety Set (study 105) included all participants in the Treatment Cohort Part B who were exposed to any amount of study drug.|||participants|||Number
2623333|NCT01931839|Primary|Part A Treatment Cohort: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: as any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or newly developed at or after initial dosing of study drug was considered treatment-emergent.|Day 1 up to Week 105 (Study 105)|Safety Set (study 105) included all participants in Treatment Cohort Part A who were exposed to any amount of study drug.|||participants|||Number
2623334|NCT01931735|Secondary|TNFa|Tumor necrosis factor-alpha (TNFa) is a pro-inflammatory cytokine that has been linked to the presence of radiographic signs of osteoarthritis (OA), cartilage volume loss over time, increased disease severity, and risk of OA progression. Elevated presence of TNFa can indicate more risk for OA. The unit of measure is pg/mL.|Baseline|No participants were assessed for this measure (data were not collected).||||||
2623335|NCT01931735|Secondary|KOOS Pain Score|Knee injury and Osteoarthritis Outcome Score (KOOS) is a standardized and validated survey used to evaluate the condition of osteoarthritis of the knee. The KOOS Pain scale consists of 9 questions, with each response valued on an ordinal scale of 0-4, and with at total score of 36. Higher numbers indicate more symptoms and physical disabilities. The score is then transformed into a percentage, where 0% is the worst pain and 100% is no pain.|one year post baseline|Randomize meniscectomy: 2 lost to follow-up. Randomized Lavage: 2 lost to follow-up. Standard of care meniscectomy pre-amendment: 5 lost to follow-up. Standard of care meniscectomy post-amendment: 1 withdraw|||units on a scale||Standard Deviation|Mean
2623336|NCT01931735|Secondary|KOOS Pain Score|Knee injury and Osteoarthritis Outcome Score (KOOS) is a standardized and validated survey used to evaluate the condition of osteoarthritis of the knee. The KOOS Pain scale consists of 9 questions, with each response valued on an ordinal scale of 0-4, and with at total score of 36. Higher numbers indicate more symptoms and physical disabilities. The score is then transformed into a percentage, where 0% is the worst pain and 100% is no pain.|two years post baseline|Randomize meniscectomy: 2 lost to follow-up. Randomized Lavage: 2 lost to follow-up. Standard of care meniscectomy pre-amendment: not in protocol to follow subjects 2 years post baseline. Standard of care meniscectomy post-amendment: 1 withdraw, 1 adverse event.|||units on a scale||Standard Deviation|Mean
2623337|NCT01931735|Primary|Average Rotation During Stance|Degree of external tibial rotation averaged over the stance phase of gait.|Two years post baseline|Standard of Care Meniscectomy Pre-Amendment group were not assessed for this outcome. Randomized Meniscectomy: 1 was not assessed due to relocation, 2 were lost to follow-up. Randomized lavage: 2 participants were lost to follow-up. Standard of Care Meniscectomy Post Amendment: 1 had an adverse event, 1 participant withdrew from the study.|||degrees||Standard Deviation|Mean
2623338|NCT01931735|Primary|Gait Knee Adduction Moment|Knee adduction moment describes the medial/lateral load distribution of the knee measured while walking in a gait laboratory. Before normalization to account for size, the knee adduction moment is expressed in Nm. However, to account for different sized people, the knee adduction moment is transformed and expressed in percentage of body weight times height (%BW*ht). Higher knee adduction moments have been linked to more severe osteoarthritis (OA).|Two year post baseline|Standard of Care Meniscectomy Pre-Amendment group were not assessed for this outcome. Randomized Meniscectomy: 1 was not assessed due to relocation, 2 were lost to follow-up. Randomized lavage: 2 participants were lost to follow-up. Standard of Care Meniscectomy Post Amendment: 1 had an adverse event, 1 participant withdrew from the study.|||percentage of body weight times height||Standard Deviation|Mean
2623365|NCT01931670|Secondary|Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS|The DYS pain scale ranges from 0 (none) to 3 (severe).|Baseline (Prior to administering study drug), Months 1, 2, 3, 4, 5 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.|||units on a scale||Standard Error|Least Squares Mean
2623340|NCT01931735|Primary|WOMET Score|Western Ontario Meniscal Evaluation Tool (WOMET) is a standardized and validated survey used to evaluate the pain and function of patients with a degenerative meniscal tear. The survey consists of 16 questions regarding physical symptoms, sports/recreation/work/lifestyle, and emotions. Each question is answered via a visual analog scale (VAS) of 0-100mm for a total score of 1600, where higher numbers are worse. The score is then transformed into a percentage, where 0 is the worst pain and functioning and 100% is no pain and fully functioning.|one year post baseline|Randomize Meniscectomy: 2 lost to follow-up. Randomized Lavage: 2 lost to follow-up. Standard of Care Meniscectomy Pre-Amendment: 5 lost to follow-up. Standard of Care Meniscectomy Post Amendment: 1 withdrew participation.|||units on a scale||Standard Deviation|Mean
2623341|NCT01931709|Secondary|Percent Change in DCE-MRI Peak Percent Enhancement (Peak PE) Between Mid-therapy and Pre-therapy Breast MRI Scans and Its Association With Pathologic Response|Percent change in tumor enhancement between pre-therapy and mid-therapy DCE-MRI scans as represented by the MRI measure Peak PE % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response.|Baseline to up to 12 weeks (mid-therapy)|"One participant had to be excluded from this analysis:~[1] pathologic response could not be evaluated due to a metastatic disease progression prior to surgery."|||percent change||Full Range|Median
2623342|NCT01931709|Secondary|Overall Survival|Will be examined using Cox proportional hazards regression.|From time of surgery until death, assessed up to 5 years|||||||
2623343|NCT01931709|Secondary|Time From Surgery to Breast Cancer Recurrence or Death|Will be examined using Cox proportional hazards regression.|From surgery to breast cancer recurrence or death, assessed up to 5 years|||||||
2623344|NCT01931709|Secondary|Percent Change in Tumor Metabolism / Perfusion Ratio (MRFDG/K1) Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response|Percent change in tumor metabolism / perfusion ratio between pre-therapy and mid-therapy FDG PET scans as represented by the PET measure MRFDG/K1 (parametric) % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response.|Baseline to up to 12 weeks (mid-therapy)|"Three participants had to be excluded from this analysis:~mid-therapy PET images got lost due to a technical error;~pre-therapy scanning procedure had 40 seconds delayed start, preventing the modeling of parametric outcomes;~pathologic response could not be evaluated due to a metastatic disease progression prior to surgery."|||percent change||Full Range|Median
2623345|NCT01931709|Secondary|Percent Change in PET K1 Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response|Percent change in tumor perfusion between pre-therapy and mid-therapy FDG PET scans as represented by the PET measure K1 (parametric) % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response.|Baseline to up to 12 weeks (mid-therapy)|"Three participants had to be excluded from this analysis:~mid-therapy PET images got lost due to a technical error;~pre-therapy scanning procedure had 40 seconds delayed start, preventing the modeling of parametric outcomes;~pathologic response could not be evaluated due to a metastatic disease progression prior to surgery."|||percent change||Full Range|Median
2623346|NCT01931709|Primary|Number of Participants With Favorable Pathologic Response at Surgery|"The primary clinical endpoint is dichotomous (yes/no) - Has patient achieved favorable microscopic pathologic response at surgery? This favorable pathologic response is defined as:~No evidence of microscopic invasive tumor at the primary tumor site and in regional axillary lymph nodes = Residual Cancer Burden class 0 (RCB 0)~Minimal invasive residual disease at primary tumor site and/or in regional axillary lymph nodes = Residual Cancer Burden class I (RCB I)"|At time of surgery||||Participants|||Count of Participants
2623347|NCT01931670|Secondary|Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type|This is assessed using HRUQ.|Up to Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug.|||Participants|||Count of Participants
2623348|NCT01931670|Secondary|Number of Days of Hospitalization|This is assessed using HRUQ.|Up to Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Includes participants who were hospitalized during the Treatment Period.|||days||Standard Deviation|Mean
2623349|NCT01931670|Secondary|Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period|This is assessed using Health Resource Utilization Questionnaire (HRUQ).|Months 1, 2, 3, 4, 5, 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug.|||Participants|||Count of Participants
2623350|NCT01931670|Secondary|Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.|Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.|||hours||Standard Error|Least Squares Mean
2623351|NCT01931670|Secondary|Change From Baseline to Each Month in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.|Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.|||hours||Standard Error|Least Squares Mean
2623352|NCT01931670|Secondary|Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.|Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.|||hours||Standard Error|Least Squares Mean
2623353|NCT01931670|Secondary|Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.|Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.|||hours||Standard Error|Least Squares Mean
2623354|NCT01931670|Secondary|Change From Baseline to Each Month in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.|Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.|||hours||Standard Error|Least Squares Mean
2623355|NCT01931670|Secondary|Change From Baseline to Each Month in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.|Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.|||hours||Standard Error|Least Squares Mean
2623356|NCT01931670|Secondary|Change From Baseline to Each Scheduled Assessment in the Sexual Intercourse Domain of EHP-30 Questionnaire Scores|The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.|Baseline, Months 1, 3, 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.|||units on a scale||Standard Error|Least Squares Mean
2623357|NCT01931670|Secondary|Change From Baseline to Each Scheduled Assessment in the Pain Domain of Endometriosis Health Profile-30 (EHP-30) Questionnaire Scores|The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.|Baseline, Months 1, 3, 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.|||units on a scale||Standard Error|Least Squares Mean
2623358|NCT01931670|Secondary|Change From Baseline to Each Month, Except Month 3, in NRS Scores|The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).|Baseline, Months 1, 2, 4, 5, 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.|||units on a scale||Standard Error|Least Squares Mean
2623359|NCT01931670|Secondary|Patient Global Impression of Change (PGIC) Questionnaire|The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.|Months 1, 2, 3, 4, 5, 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. Participants with an assessment at given time point.|||units on a scale||Standard Error|Least Squares Mean
2623360|NCT01931670|Secondary|Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics|Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.|Baseline, Months 1, 2, 4, 5|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||number of pills||Standard Error|Least Squares Mean
2623361|NCT01931670|Secondary|Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP|The DYSP pain scale ranged from 0 (absent) to 3 (severe).|Baseline, Months 1, 2, 4, 5, 6 of Treatment Period|"The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded not applicable for the entire time point and at Baseline are excluded from the analysis. Participants with an assessment at given timepoint."|||units on a scale||Standard Error|Least Squares Mean
2623362|NCT01931670|Secondary|Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe).|Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.|||percentage change||Standard Deviation|Least Squares Mean
2623363|NCT01931670|Secondary|Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe).|Baseline, Months 1, 2, 3, 4, 5 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.|||units on a scale||Standard Error|Least Squares Mean
2623364|NCT01931670|Secondary|Percent Change From Baseline to Each Month in Mean Pain Score for DYS|The DYS pain scale ranges from 0 (none) to 3 (severe).|Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.|||percentage change||Standard Error|Least Squares Mean
2624118|NCT01926028|Secondary|Time to First VVC Episode From Study Day 17 to 360 - All Participants|Time-to-onset of first VVC episode from Study Day 17 for the NDV-3A vaccine group and the placebo group|12 months|All participants|||Days||Inter-Quartile Range|Median
2623366|NCT01931670|Secondary|Percentage of Responders at Each Month for DYSP|The DYSP pain scale ranged from 0 (absent) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.29 or greater from Baseline in DYSP as well as no increased rescue analgesic use for endometriosis-associated pain.|Months 1, 2, 3, 4, 5, 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. Participants with an assessment at given time point.|||percentage of participants|||Number
2623367|NCT01931670|Secondary|Percentage of Responders for Each Month, Except Month 3, in NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.|Months 1, 2, 4, 5, 6 of the Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. Participants with an assessment at given time point.|||percentage of participants|||Number
2623368|NCT01931670|Secondary|Percentage of Responders for Each Month, Except Month 3, in DYS|The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.|Months 1, 2, 4, 5, 6 of the Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. Participants with an assessment at given time point.|||percentage of participants|||Number
2623369|NCT01931670|Secondary|Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)|Permitted country-specific rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen. Assessment was based on average pill counts.|Baseline, Month 3 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||number of pills||Standard Error|Least Squares Mean
2623370|NCT01931670|Secondary|Change From Baseline to Month 3 in Dyspareunia (DYSP)|The DYSP pain scale ranges from 0 (absent) to 3 (severe).|Baseline, Month 3 of Treatment Period|"The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded not applicable for the entire time point and at Baseline are excluded from the analysis."|||units on a scale||Standard Error|Least Squares Mean
2623371|NCT01931670|Secondary|Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics|Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.|Baseline, Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||number of pills||Standard Error|Least Squares Mean
2623372|NCT01931670|Secondary|Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics|Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.|Baseline, Month 3 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||number of pills||Standard Error|Least Squares Mean
2623373|NCT01931670|Secondary|Change From Baseline to Month 6 in NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2623374|NCT01931670|Secondary|Change From Baseline to Month 6 in DYS|The DYS pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2623375|NCT01931670|Secondary|Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores|The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).|Baseline, Month 3 of the Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2623376|NCT01931670|Primary|Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)|The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.|At Month 3 of Treatment Period|The mITT analysis set; all randomized participants who took at least 1 dose of randomized, double-blind study drug. Population included mITT participants who either had data during the Month 3 35-day window or who prematurely discontinued prior to or at Month 3 and met the rules for last observation carried forward.|||percentage of participants|||Number
2623377|NCT01931670|Primary|Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)|The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.|At Month 3 of the Treatment Period|The modified intent-to-treat (mITT) analysis set; all randomized participants who took at least 1 dose of randomized, double-blind study drug. Population included mITT participants who either had data during the Month 3 35-day window or who prematurely discontinued prior to or at Month 3 and met the rules for last observation carried forward.|||percentage of participants|||Number
2623941|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Haematology: Neutrophils)|Change from baseline (within 4 weeks prior to week 0) in haematological parameter - neutrophils. Missing values were imputed using the LOCF method.|Baseline, week 208|SAS.|||Percentage of neutrophils||Standard Deviation|Mean
2623378|NCT01931566|Secondary|Change From Baseline in Instrumental Activities of Daily Living (Alzheimer's Disease Cooperative Study Activities of Daily Living - Prevention Instrument [ADCS ADL-PI]) Between Pioglitazone-treated and Placebo-treated Groups of the High-risk Stratum|The ADCS ADL-PI is a functional measure that was specifically designed for standardized administration over long duration clinical studies to prevent AD. The ADCS ADL-PI is a 20-item instrument that included 15 ADL questions, which were scored as 1 (with a lot of difficulty), 2 (with some difficulty), or 3 (as well as usually, with no difficulty), plus 5 vision, hearing, and mobility questions, which were scored from 0 (no) to 1 (yes). ADL Total ranged from 0 to 45, and lower scores indicated greater disability.|Baseline and Month 48|FAS included all participants who were randomized, received at least 1 dose of study drug, and at least 1 valid postbaseline value for assessment of primary efficacy. Number analyzed is the number of participants with evaluable data at the given time-point.|||score on a scale||Standard Deviation|Mean
2623379|NCT01931566|Secondary|Change From Baseline for Cognitive Decline on Composite Score on the Cognitive Test Battery for Pioglitazone-treated Participants Versus Placebo-treated Participants in the High-risk Stratum|Composite scores derived from the test battery. Domains of Episodic Memory [California Verbal Learning Test-2nd Edition (CVLT-II), Brief Visuospatial Memory Test-Revised (BVMT-R)]; Executive Function [Trail Making Test (TMT) (Part B), Wechsler Adult Intelligence Scale (WAIS)-III Digit Span Test-backwards span]; Language [Multilingual Naming Test (MiNT), Semantic Fluency (animals), Lexical/phonemic fluency (F, A, and S in English; D, S, and F in German)]; and Attention [WAIS-III Digit Span Test-forward span, TMT (Part A)] used for composite score. 12 measures were derived from 8 neuropsychological tests. CVLT-II test involved 2 primary measures (short, long delay recall); BVMT-R had 2 measures (copy and recall); Digit Span and Trail both had 2 measures (forward and backward span and Parts A and B). There was 1 total score for each test: CDT, MINT, semantic and lexical fluency. Total score ranged from -1.222 to 1.707 at baseline, a higher composite score indicated better cognition.|Baseline and Month 48|FAS included all participants who were randomized, received at least 1 dose of study drug, and at least 1 valid postbaseline value for assessment of primary efficacy. Number analyzed is the number of participants with evaluable data at the given time-point.|||score on a scale||Standard Deviation|Mean
2623380|NCT01931566|Primary|Time to Diagnosis of MCI Due to AD for Pioglitazone-treated, High-risk, Non-Hispanic/Latino Caucasian Participants Versus Placebo-treated, High-risk, Non-Hispanic/Latino, Caucasian Participants|The event definition for MCI-AD was the time in days from the randomization date to the date of the first of two consecutive scheduled visits at which a participant was assessed with a diagnosis of MCI due to AD confirmed by adjudication committee. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to the largest event time.|Baseline to the end of study (approximately up to 5 years)|FAS included all participants who were randomized, received at least 1 dose of study drug, and at least 1 valid postbaseline value for assessment of primary efficacy. A participant who does not have an event of MCI due to AD was censored at the date of the last visit at which MCI due to AD could have been assessed.|||days||Full Range|Mean
2623381|NCT01931566|Primary|Time to Diagnosis of Mild Cognitive Impairment Due to Alzheimer's Disease (MCI-AD) for Placebo-treated, High-risk, Non-Hispanic/Latino Caucasian Participants Versus Placebo-treated, Low-risk, Non-Hispanic/Latino Caucasian Participants|The event definition for MCI-AD was the time in days from the randomization date to the date of the first of two consecutive scheduled visits at which a participant was assessed with a diagnosis of MCI due to AD confirmed by adjudication committee. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to the largest event time.|Baseline to the end of study (approximately up to 5 years)|Full Analysis Set (FAS) included all participants who were randomized, received at least 1 dose of study drug, and at least 1 valid postbaseline value for assessment of primary efficacy. A participant who does not have an event of MCI due to AD was censored at the date of the last visit at which MCI due to AD could have been assessed.|||days||Full Range|Mean
2623382|NCT01931527|Secondary|AFTER Rasburicase Plasma FRAP (Fe⁺² · Lˉ¹)|Ferric-Reducing Antioxidant Potential|12 hours after reducing uric acid|AFTER rasburicase plasma FRAP only measured in subjects with high uric acid|||mmol Fe⁺² · Lˉ¹||Standard Error|Mean
2623383|NCT01931527|Secondary|Baseline Plasma FRAP|Ferric-Reducing Antioxidant Potential|Before reducing uric acid||||mmol Fe⁺² · Lˉ¹||Standard Error|Mean
2623384|NCT01931527|Secondary|AFTER Rasburicase Plasma TRAP|Total Radical-Trapping Antioxidant Potential|12 hours after reducing uric acid|AFTER rasburicase plasma Total Radical-Trapping Antioxidant Potential (TRAP) was only measured in the subjects with high uric acid|||mmol · Lˉ¹||Standard Error|Mean
2623385|NCT01931527|Secondary|Baseline Plasma TRAP|Total Radical-Trapping Antioxidant Potential|Before reducing uric acid||||mmol · Lˉ¹||Standard Error|Mean
2623386|NCT01931527|Secondary|AFTER Rasburicase Carbonylated Protein Ratio|Baseline ratio of total carbonylated proteins to the loading control protein Ran in skeletal muscle|12 hours after reducing uric acid|Analysis only completed on subjects in the High Uric Acid group|||Ratio||Standard Error|Mean
2623387|NCT01931527|Secondary|Baseline Carbonylated Protein Ratio|Baseline ratio of total carbonylated proteins to the loading control protein Ran in skeletal muscle|Before reducing uric acid||||Ratio||Standard Error|Mean
2623388|NCT01931527|Secondary|The Effect of Reducing Uric Acid on Oxidative Status|Uric acid will be reduced to 0 with a 30 minute infusion of a uricase (Elitek, Sanofi-Aventis). Systemic (urinary isoprostanes) and skeletal muscle (carbonylated protein ratio) oxidative stress and total antioxidant capacity (plasma TRAP and FRAP) will be measured in obese subjects with high uric acid before and after uric acid reduction. Levels of isoprostanes were normalized to urinary creatinine and reported at ng/mg.|12 hours after reducing uric acid||||ng/mg||Standard Error|Mean
2623389|NCT01931527|Primary|Percent Increase in Insulin-stimulated Glucose Uptake|Uric acid will be reduced to 0 with a 30 minute infusion of a uricase (Elitek, Sanofi-Aventis). A hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope glucose tracer infusion will be used to measure percent increase in insulin-stimulated glucose uptake in obese subjects with high uric acid before and after uric acid reduction.|12 hours after reducing uric acid||||% incr. in insulin-mediated gluc. uptake||Standard Error|Mean
2623390|NCT01931475|Secondary|Percentage of Participants With Response to Treatment on Patient Global Impression-Improvement (PGI-I) at Endpoint|"PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). Response to treatment is defined by endpoint PGI rating of either much better or very much better.The last observation carried forward (LOCF) method will be used for these analyses."|Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||percentage of participants|||Number
2623391|NCT01931475|Secondary|Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score|Pain severity was measured using an 11 point BPI scale from 0 (no pain) to 10 (worst pain) to determine average pain in the past 24 hours (average pain). A 30% (or 50%) improvement was defined as a ≥30% (or ≥50%) reduction in BPI pain severity from baseline to endpoint. Percentage of participants = (number of participants with ≥30% or ≥50% pain reduction / total number of participants in treatment group) * 100.The last observation carried forward (LOCF) method will be used for these analyses.|Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||percentage of participants|||Number
2623392|NCT01931475|Secondary|Change in Brief Pain Inventory (BPI) Average Pain Intensity Scores, Hospital Anxiety and Depression Scale (HADS) Depression Subscale (HADS-D) and HADS Anxiety Subscale (HADS-A)|Evaluation on whether the change in BPI average pain intensity scores is a direct analgesic effect of duloxetine and is independent of treatment effect on mood, as measured by Hospital Anxiety and Depression Scale (HADS) depression subscale (HADS-D), or anxiety as measured by HADS anxiety subscale (HADS-A). Path analysis for the direct analgesic effect was used to test the null hypothesis that the change in BPI average pain severity depends on the improvement of HADS-D or HADS-A, versus the alternative that the improvement in BPI average pain severity is due to a direct analgesic effect of the treatment and not dependent upon the improvement in depression and anxiety symptoms.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||units on a scale||Standard Deviation|Mean
2623393|NCT01931475|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale-Depression (HADS-D) or HADS-Anxiety (HADS-A) Subscale Scores|HADS is a 14-item questionnaire with 2 subscales: anxiety and depression. Each item was rated on a 4-point scale [0 (low level of anxiety or depression) to 3 (high level of anxiety or depression)], giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale were considered to be a 'significant' case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.' Mean was calculated using analysis of covariance (ANCOVA) and adjusted for treatment, pooled investigator, and baseline score. The last observation carried forward (LOCF) method will be used for these analyses.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||units on a scale||Standard Error|Mean
2623394|NCT01931475|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Interference|BPI Interference Average Score is a self-reported scale that measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people,sleep, and enjoyment of life.The average Interference scores ranged from 0 to 10. General activity, mood,walking ability, normal work,relations with other people, sleep and enjoyment of life is each is a self-reported scale that measures the interference of pain in the past 24 hours on general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life.The Interference scores ranged from 0 (does not interfere) to 10 (completely interferes).Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
2623395|NCT01931475|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Severity|BPI Severity of Worst Pain is self-reported scale that measures the severity of pain based on the worst pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). BPI Severity of Least Pain is a self-reported scale that measures the severity of pain based on the least pain experienced during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). BPI Severity of Right Now Pain is a self-reported scale that measures the severity of pain based on the pain right now. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
2623396|NCT01931475|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score|CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline,13 Weeks|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
2623411|NCT01931397|Primary|Variability of Tacrolimus Blood Levels Measured by DBS Over Time|Mean standard deviation scores for Tacrolimus blood levels obtained by DBS for each patient over time.|12 months|9 participants were excluded from final analysis because they submitted two or less evaluable blood samples. A total of 216 DBS samples were received during the study|||ng/ml|blood samples|Standard Deviation|Mean
2623420|NCT01931202|Secondary|Credibility and Expectancy Scale-Better (CES)|CES is an 8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. Question 2 ('Better') asks the patient the chances of their depression being completely better at the end of this study, from 1 = very poor to 7 = very good. The higher the number, the higher the expectancy that they will be better.|Pre-Baseline|138 subjects were consented, of which 108 were randomized, however only 101 completed pre-baseline Credibility and Expectancy Scale-Better (CES).|||units on a scale||Standard Deviation|Mean
2623397|NCT01931475|Secondary|Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Total and Subscale Scores|WOMAC consists of 24 items divided into 3 subscales:Pain(5 items):during walking,using stairs,in bed,sitting or lying,and standing Stiffness;(2 items):after first waking and later in the day Physical Function;(17 items):stair use,rising from sitting, standing, bending,walking,getting in/out of a car,shopping,putting on/taking off socks,rising from bed,lying in bed,getting in/out of bath,sitting,getting on/off toilet,heavy household duties,light household duties.Each question is answered using a 5-point Likert scale(0 to 4).Pain subscale has a range of scores of 0(none) to 20(extreme).Stiffness subscale has a range of scores of 0(none) to 8(extreme).Physical function subscale has a range of scores of 0(none) to 68(extreme).Total score ranges from 0(none) to 96(extreme).Least squares(LS) mean was calculated using analysis of covariance(ANCOVA) and adjusted for treatment, pooled investigator,and baseline score.Last observation carried forward (LOCF) method was be used for these analyses.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
2623398|NCT01931475|Secondary|Patient Global Impressions of Improvement (PGI-I) Score|PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|13 Weeks|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
2623399|NCT01931475|Primary|Change From Baseline in the Brief Pain Inventory (BPI) 24-hour Average Pain Score|BPI is a self-reported scale that measures the severity of pain based on the average pain during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.|Baseline, Week 13|All participants who were randomized and had a baseline and at least 1 post-baseline observation.|||units on a scale||Standard Error|Least Squares Mean
2623400|NCT01931462|Secondary|Complication Rates|Complication rates will be estimated using the methods of Kaplan and Meier.|During the operation||||participants with complications|||Number
2623401|NCT01931462|Secondary|Tumor Margin|The percentage of subjects with tumor positive margins will be reported. Tissue pathology will occur during the operation and a final tissue pathology will be performed 6 weeks after the operation.|During the operation and 6 weeks post-operation||||percentage with tumor positive margins|||Number
2623402|NCT01931462|Secondary|Change in Functional Renal Volume|To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring the change in functional renal volume as measured by MRI. We will calculate the mean, median, standard deviation, and range of values for change in functional renal volume as measured by MRI.|Within 30 days prior to operation and 6 weeks post-operation|Subject renal volume not measured. Only normal/abnormal renal function was assessed.||||||
2623403|NCT01931462|Secondary|Change in Renal Function|To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring the change in renal function by nuclear scan and creatinine clearance. We will calculate the mean, median, standard deviation, and range of values for change in renal function by nuclear scan and creatinine clearance.|Within 30 days prior to operation and 6 weeks post operation||||mg/dL (creatinine)|||Number
2623404|NCT01931462|Secondary|Clamp Time|To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring clamp time. We will calculate the mean, median, standard deviation, and range of values for clamp time.|During the operation|This 1 subject was not clamped during the operation.|||minutes|||Number
2623405|NCT01931462|Secondary|Operative Time|To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring operative time. We will calculate the mean, median, standard deviation, and range of values for operative time.|During the operation||||minutes|||Number
2623406|NCT01931462|Secondary|Blood Loss|To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring blood loss. We will calculate the mean, median, standard deviation, and range of values for blood loss.|During the operation||||mL|||Number
2623407|NCT01931462|Primary|To Assess the Effectiveness of Microwave Pre-coagulation Using the Certus 140™ System for Partial Nephrectomy on Renal Function Using the Estimated Glomerular Filtration Rate.|We will be measuring the change in renal function as quantified by pre- and post-surgical estimated Glomerular Filtration Rate. Change = (6 week score - Baseline score)|30 days prior to surgery (Baseline) and 6 weeks post surgery||||estimated Glomerular Filtration Rate|||Number
2623408|NCT01931397|Other Pre-specified|Changes in Adherence Parameters to Home DBS Method|"We will calculate the percent of returned DBS filter papers to OHSU on a monthly basis utilized for TAC and Cr analysis.~we calculated the percentage as the number of DBS that were actually received divided by the total number of DBS expected to be received from participants over the study time period"|At baseline then every 3 months for 12 months|The number of DBS cards expected to be received by those 28 patients were 279 DBS samples.|||percentage of DBS cards|Total number of DBS cards||Number
2623409|NCT01931397|Other Pre-specified|Mean Tacrolimus Blood Levels Measured by DBS Over Study Period According to Age|Mean Tacrolimus blood levels obtained by DBS in each patient over their time in the study in children who are 12 years and over versus those less than 12 years of age.|up to 12 months|We analyzed a total of 216 dried blood spots for Tacrolimus blood levels measured in ng/ml|||ng/ml|number of blood samples|Standard Deviation|Mean
2623410|NCT01931397|Secondary|Percentage of Families Preferring DBS Method|"The % of families who anticipated preference of DBS method over intravenous blood draws at the time of enrollment and then the % of those who preferred DBS at end of study period (12 months).~Families include parents/caregivers and participants who are over 10 years of age were asked to fill in the preference scale separately.~Preference for DBS Testing was measured using a Visual Analog Scale (VAS) on which a zero was equivalent to no preference for DBS versus laboratory-based monitoring and on which positive numbers indicated greater preference for DBS (up to +72) and negative scores indicated a greater preference for laboratory-based monitoring (down to -72)."|At baseline and then at 12 months|25 families participated in the preference survey at time of enrollment and only 15 families completed the survey at the end of the study period (12 months).|||% of families|||Number
2623412|NCT01931202|Secondary|White Matter Hyperintensity (WMH) Outcome- Total WMH|Magnetic Resonance Imaging (MRI) of the Brain was acquired. We rated the severity of WMH on axial T2 FLAIR images using the Fazekas modified Coffey Rating Scale. Deep WMH are scored as 0 (absent), 1 (punctate foci), 2 (beginning confluence of foci), and 3 (large confluent areas); subcortical gray matter HIs (basal ganglia) are scored as 0 (absent), 1 (punctate), 2 (multipunctate), and 3 (diffuse); periventricular HIs are scored as 0 (absent), 1 (caps), 2 (smooth halo), and 3 (irregular and extending into the deep white matter). Our primary measure of WMH burden will be DWMH score, which has been used to establish the only empirically validated diagnostic criteria for vascular depression, where scores of 0-1 were normal, but 2-3 indicated WHM.|Pre-Baseline|138 subjects signed consent and 108 were randomized, however not all participants underwent MRI scanning.|||score on a scale||Standard Deviation|Mean
2623413|NCT01931202|Secondary|Executive Dysfunction: Stroop Interference|The Stroop is a measure of inhibition under distracting conditions that is sensitive to frontal lobe dysfunction. in Stroop Color Word test patients are to name the color of a word rather than reading the word. Stroop Color Word is how many colors they can name in 45 sec (higher is better, e.g., less executive dysfunction). Stroop Interference is this score adjusted for age and education.|Pre-Baseline|138 subjects were consented, of which 108 were randomized, however only 105 completed pre-baseline Executive Dysfunction: Stroop Interference.|||correct items||Standard Deviation|Mean
2623414|NCT01931202|Secondary|Executive Dysfunction: Stroop Color Word|Stroop Color Word test asks patients to name the color of a word rather than reading the word. Stroop Color Word is how many colors they can name in 45 sec (higher is better, e.g., less executive dysfunction).|Pre-Baseline|138 subjects were consented, of which 108 were randomized, however only 106 completed pre-baseline Executive Dysfunction: Stroop Color Word.|||correct items||Standard Deviation|Mean
2623415|NCT01931202|Secondary|Quick Inventory of Depression Scale (QIDS-SR): Expectancy|This 16-items assessment is used to rate the 9 criterion symptom domains of a major depressive episode: 4 items are used to rate sleep disturbance (early, middle, and late insomnia plus hypersomnia); 2 items are used to rate psychomotor disturbance (agitation and retardation); 4 items are used to rate appetite/weight disturbance (appetite increase or decrease and weight increase or decrease). Only 1 item is used to rate the remaining 6 domains (depressed mood, decreased interest, decreased energy, worthlessness/guilt, concentration/decision making, and suicidal ideation). Each item is rated 0-3. For symptom domains that require more than 1 item, the highest score of the item relevant for each domain is taken. The total score ranges from 0-27. A lower rating indicates higher expectancy of improvement and lower expectation of depressive symptomatology, and a higher rating indicates lower expectancy of improvement, higher expectation of depression.|Week 0|138 subjects were consented, of which 108 were randomized, however only 107 completed week 0 Quick Inventory of Depression Scale (QIDS-SR): Expectancy.|||units on a scale||Standard Deviation|Mean
2623416|NCT01931202|Secondary|Quick Inventory of Depression Scale (QIDS-SR): Expectancy|This 16-items assessment is used to rate the 9 criterion symptom domains of a major depressive episode: 4 items are used to rate sleep disturbance (early, middle, and late insomnia plus hypersomnia); 2 items are used to rate psychomotor disturbance (agitation and retardation); 4 items are used to rate appetite/weight disturbance (appetite increase or decrease and weight increase or decrease). Only 1 item is used to rate the remaining 6 domains (depressed mood, decreased interest, decreased energy, worthlessness/guilt, concentration/decision making, and suicidal ideation). Each item is rated 0-3. For symptom domains that require more than 1 item, the highest score of the item relevant for each domain is taken. The total score ranges from 0-27. A lower rating indicates higher expectancy of improvement and lower expectation of depressive symptomatology, and a higher rating indicates lower expectancy of improvement, higher expectation of depression.|Pre-Baseline|138 subjects were consented, of which 108 were randomized, however only 101 completed pre-baseline Quick Inventory of Depression Scale (QIDS-SR): Expectancy.|||units on a scale||Standard Deviation|Mean
2623417|NCT01931202|Secondary|Credibility and Expectancy Scale-Depression|CES is an 8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. CES question 3 ('Depression') asks how the patient's depression will be at the end of the study, compared with now, from 1 = much worse to 7= much better. The higher the number, the higher the expectancy that their depression will be much better.|Week 0|138 subjects were consented, of which 108 were randomized, however only 106 completed week 0 Credibility and Expectancy Scale-Depression.|||units on a scale||Standard Deviation|Mean
2623418|NCT01931202|Secondary|Credibility and Expectancy Scale-Depression|CES is an 8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. CES question 3 ('Depression') asks how the patient's depression will be at the end of the study, compared with now, from 1 = much worse to 7= much better. The higher the number, the higher the expectancy that their depression will be much better.|Pre-baseline|138 subjects were consented, of which 108 were randomized, however only 101 completed pre-baseline Credibility and Expectancy Scale-Depression.|||units on a scale||Standard Deviation|Mean
2623419|NCT01931202|Secondary|Credibility and Expectancy Scale-Better (CES)|CES is an 8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. Question 2 ('Better') asks the patient the chances of their depression being completely better at the end of this study, from 1 = very poor to 7 = very good. The higher the number, the higher the expectancy that they will be better.|Week 0|138 subjects were consented, of which 108 were randomized, however only 106 completed week 0 Credibility and Expectancy Scale-Better (CES).|||units on a scale||Standard Deviation|Mean
2623421|NCT01931202|Secondary|Quick Inventory of Depressive Symptoms (QIDS-SR)|QIDS-SR is a 16 item scale self-report form that was used to measure depression outcomes. This self-report is valuable in this study, because it is less susceptible to clinician and rater bias. The QIDS-SR has been increasingly used in antidepressant studies due to its equivalent weightings for each symptom item, clearly understandable anchor points, and inclusion of all DSM criteria for depression. The scores range from 0-27 with 27 being worse depressive symptoms.|Week 8|138 subjects were consented, of which 108 were randomized, however only 99 completed week 8 Quick Inventory of Depressive Symptoms (QIDS-SR).|||units on a scale||Standard Deviation|Mean
2623422|NCT01931202|Secondary|Quick Inventory of Depressive Symptoms (QIDS-SR)|QIDS-SR is a 16 item scale self-report form that was used to measure depression outcomes. This self-report is valuable in this study, because it is less susceptible to clinician and rater bias. The QIDS-SR has been increasingly used in antidepressant studies due to its equivalent weightings for each symptom item, clearly understandable anchor points, and inclusion of all DSM criteria for depression. The scores range from 0-27 with 27 being worse depressive symptoms.|Baseline|138 subjects were consented, of which 108 were randomized, however only 107 completed baseline Quick Inventory of Depressive Symptoms (QIDS-SR).|||units on a scale||Standard Deviation|Mean
2623423|NCT01931202|Secondary|Hamilton Rating Scale for Depression (HRSD)|Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluate recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score of 16 or above is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.|Week 8|Although 138 subjects were enrolled (signed consent) and 108 were randomized, only 99 completed the Hamilton Rating Scale for Depression (HRSD) at week 8.|||units on a scale||Standard Deviation|Mean
2623424|NCT01931202|Primary|Hamilton Rating Scale for Depression (HRSD)|Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluate recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score of 16 or above is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity.|Baseline||||units on a scale||Standard Deviation|Mean
2623425|NCT01931150|Primary|Number of Patients in Which the PI Observed a Notable Difference in the Number of Lesions|Change from Baseline in the Number of Lesions at 28 days|28 days||||participants|||Number
2623426|NCT01931059|Other Pre-specified|Feedback-based Probabilistic Classification Task|On each trial, participants will view one of four images and will be asked to guess whether it belongs to Category A or B. For each participant, the four images will be randomly assigned to be stimuli S1, S2, S3 and S4 (these are abstract visual stimuli denoted with numbers (stiumulus 1, stimulus 2, etc). A different set of similar images (S5-S8; S9-S12, etc) will be used for repeated testing. On any given trial, stimuli S1 and S3 will belong to Category A with 90% probability and to Category B with 10% probability, while stimuli S2 and S4 will belong to Category B with 90% probability and to Category A with 10% probability. Stimuli S1 and S2 will be used in the reward-learning task and S3 and S4 in punishment-learning task. Two stimuli per valence will be employed in order to balance category outcome frequencies, so that one stimulus in each task will be associated with each outcome.|Before every MRI except the 2nd and 4th which will occur during the MRI (5 times - 3 consecutive days)|We lumped individuals from both arms to four groups depending on the task and the medication status and calculated the percentage of correct responses. Due to computer problems 3 subjects' data were lost.|||percentage of correct response||Standard Deviation|Mean
2623427|NCT01931059|Secondary|Simpson-Angus Extrapyramidal Side Effects Scale|The secondary outcome measures are the scores from side effect scales (Simpson-Angus Extrapyramidal Side Effects. It will measured in synchrony with Repeated Battery for the Assessment of Neuropsychological Status to explore if any of these measures would correlate with network changes in the brain. The Simpson-Angus scale is 0 if there is no extrapyramidal side effects, and is higher the worst the symptoms are.|2 times on risperidone day and on placebo day|We analyzed the difference between patients who received drug versus placebo on the first day. 0 would mean no side effects after administration of risperidone or placebo.|||units on a scale||Standard Deviation|Mean
2623428|NCT01931059|Primary|Repeatable Battery for the Assessment of Neuropsychological Status|"This will measure the subject's cognitive performance. RBANS is a well-characterized repeatable battery to measure a wide array of cognitive performance in different cognitive domains. We will use Total Score in RBANS: five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score. The Total Score is expressed as a standardized score normalized to a population mean of 100, with a standard deviation of 15 (possible scores 40-135). Higher scores reflect better performance. More detailed information is available: Randolph C, Tierney MC, Mohr E, Chase TN (June 1998). The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 20 (3): 310-9. doi:10.1076/jcen.20.3.310.823. PMID 9845158.~Here we calculated the difference of T-scaled total RBANS score between risperidone day and placebo day in all participants"|The change of RBANS scores between placebo and treatment conditions on two consecutive days||||RBANS T-Scale point difference||Standard Deviation|Mean
2623429|NCT01930890|Primary|Number of Participants Who Discontinued Study Treatment or Withdrew From Study Due to an AE|AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.|Up to Week 108|The safety population was defined as all participants who received at least 1 dose of study treatment (3 or 20 mg/kg BIIB023 in Study 211LE202).|||participants|||Number
2623430|NCT01930890|Primary|Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs with a start date on or after the first dose date in study 211LE202. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.|Up to Week 108|The safety population was defined as all participants who received at least 1 dose of study treatment (3 or 20 mg/kg BIIB023 in Study 211LE202).|||participants|||Number
2623431|NCT01930799|Secondary|Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire|"The Patient Post-Video Questionnaire was based on 5 individual questions assessing the patient's perception of the utility of the video in helping them 1) understand how MS can affect the bladder, 2) how to recognize bladder symptoms, 3) understand various treatment options, 4) understand self-help strategies, and 5) better manage their bladder problems. Percentages represent the proportion of patients who agree/completely agree with each question. Patients viewed the video at the Baseline visit, then completed the Patient Post-Video Questionnaire immediately after viewing the video at the Baseline visit."|Baseline|Eligible enrolled subjects|||Percentage of Patients|||Number
2623432|NCT01930799|Primary|Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores|The KHQ is a valid and reliable patient reported outcome measure for the assessment of quality of life in subjects with urinary incontinence that contains the following 8 domains: general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relations, emotions, sleep/energy, and severity measures. The KHQ domain scores are based on a scale of 0-100, with a lower score indicating less severity. Decreases in KHQ domain scores indicate an improvement in quality of life and increases in KHQ domain scores indicate a worsening in quality of life.|Baseline, Month 6|Eligible and enrolled subjects who completed the Month 6 visit|||Scores on a Scale||Standard Deviation|Mean
2623433|NCT01930747|Secondary|Adverse Events Difference Between the Three Groups|"To compare the major adverse events among the patient groups who receive the different agents listed above in the primary efficacy objective"|from zero till 24 hours after recovery of surgery.||||Participants|||Count of Participants
2623434|NCT01930747|Primary|Effect of Anesthetics on the Abdominal Elastance (E) Measured During Insufflation of the Abdomen by|the impact of the following agents on the abdominal elastance (E) : remifentanyl > 0.50 µg/kg/min; sevoflurane 1 MAC and deep neuromuscular block (rocuronium given with PTC < 4).|5 min after reaching 1 MAC or haven given the anesthetics intravenous|laparoscopic bariatric surgery population|||mmHg/liter||Standard Deviation|Mean
2623435|NCT01930747|Primary|Effect of Anesthetics on the Pressure at Zero Volume (PV0) Measured During Insufflation of the Abdomen|the impact of the following agents on the pressure at zero volume (PV0): remifentanyl > 0.50 µg/kg/min; sevoflurane 1 MAC and deep neuromuscular block (rocuronium given with PTC < 4).|5 min after reaching 1 MAC or haven given the anesthetics intravenous|laparoscopic bariatric surgery population|||mmHg||Standard Deviation|Mean
2623436|NCT01930643|Secondary|Grip Power|Weekly improvement of both hand grip muscle power in kilogram(Kg)|7 days after intervention|||||||
2623437|NCT01930643|Primary|Ventilator-free Days|the cumulative ventilator-free days after intervention, in following 28 days.|28 days||||day||Inter-Quartile Range|Median
2623438|NCT01930487|Secondary|Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - No DM|change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||% zero pixels||Standard Error|Mean
2623439|NCT01930487|Secondary|Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - DM|change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||% zero pixels||Standard Error|Mean
2623440|NCT01930487|Secondary|Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - No DM|change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||% zero pixels||Standard Error|Mean
2623441|NCT01930487|Secondary|Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - DM|change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||% zero pixels||Standard Error|Mean
2623442|NCT01930487|Secondary|Change in Ocular Perfusion Pressure - No DM|change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||mm Hg||Standard Error|Mean
2623443|NCT01930487|Secondary|Change in Ocular Perfusion Pressure - DM|change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||mm Hg||Standard Error|Mean
2623444|NCT01930487|Secondary|Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM|change (post-treatment - pre-treatment) in temporal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
2623445|NCT01930487|Secondary|Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM|change (post-treatment - pre-treatment) in temporal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
2623446|NCT01930487|Secondary|Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM|change (post-treatment - pre-treatment) in nasal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
2623447|NCT01930487|Secondary|Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM|change (post-treatment - pre-treatment) in nasal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
2623448|NCT01930487|Secondary|Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - No DM|change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
2625899|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||mg/dL||Standard Deviation|Mean
2623451|NCT01930487|Secondary|Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - DM|change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
2623452|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623453|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623454|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623455|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623456|NCT01930487|Secondary|Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623457|NCT01930487|Secondary|Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623458|NCT01930487|Secondary|Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623459|NCT01930487|Secondary|Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623460|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623461|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623462|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623463|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623464|NCT01930487|Secondary|Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623465|NCT01930487|Secondary|Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623466|NCT01930487|Secondary|Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM|change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623467|NCT01930487|Secondary|Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - DM|change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623468|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)|change (post-treatment - pre-treatment) in temporal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
2623469|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio)|change (post-treatment - pre-treatment) in nasal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||ratio||Standard Error|Mean
2625900|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||mEq/L||Standard Deviation|Mean
2623472|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623473|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623474|NCT01930487|Secondary|Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623475|NCT01930487|Secondary|Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623476|NCT01930487|Secondary|Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623477|NCT01930487|Secondary|Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623478|NCT01930487|Secondary|Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623479|NCT01930487|Secondary|Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s)|change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)|baseline and 30 days|patients completing both study periods|||cm/s||Standard Error|Mean
2623480|NCT01930487|Secondary|Change in Ocular Perfusion Pressure|change (post-treatment - pre-treatment) in ocular perfusion pressure (2/3 Mean arterial pressure - intraocular pressure)|baseline and 30 days|patients completing both study periods|||mm Hg||Standard Error|Mean
2623481|NCT01930487|Primary|Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels)|change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)|baseline and 30 days|patients completing both study periods|||% zero pixels||Standard Error|Mean
2623482|NCT01930487|Primary|Change in Superior Retinal Capillary Blood Flow (% Zero Pixels)|change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)|baseline and 30 days|patients completing both study periods|||% zero pixels||Standard Error|Mean
2623483|NCT01930435|Secondary|Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification|Rate of Hospitalization in Patients Who Use Personalized Sterile Humidification, determined based on admission to hospital over active study period|during 12 weeks duration||||participants|||Number
2623484|NCT01930435|Secondary|Rate of Feeding Tube Placement Among Patients Using Personalized Sterile Humidification|Feeding Tube Placement in Patients Who Use Personalized Sterile Humidification, as determined by placement of either nasogastric or gastrostomy tube. This was enumerated as the number of participants who had a feeding tube placed.|over 12 weeks duration||||participants|||Number
2623485|NCT01930435|Secondary|Clinician Graded CTCAE-rated Mucositis Score Over 12 Weeks|The maximum severity of clinician rating of mucositis observed over 12 weeks, as graded on a scale ranging from 1 (minimal mucositis) to 3 (confluent mucositis) to 5 (death) using the Common Terminology Criteria for Adverse Events v 4.0|over 12 weeks duration||||units on a scale||Standard Deviation|Mean
2623486|NCT01930435|Secondary|Percentage of Patients Achieving Compliance With Use of Personalized Sterile Humidification.|Compliance was pre-specified in the protocol as self-reported usage of the device at a level equal to or greater than 60% of the formal recommended usage. This cut-off at 60% represented the median of the distribution of the usage of the device among all patients. The outcome measure is the percentage of participants who reported using the device at a level equal to or greater than 60% of the total prescribed usage.|over entire 12 weeks duration||||percentage of participants|||Number
2623487|NCT01930435|Primary|Mean Change in Quality of Life as Measured by the Subscale MDASI-HN Score.|"The MDASI-HN assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 NRS, with 0 being not present and 10 being as bad as you can imagine. There are 28 items in the MDASI-HN. There are 13 general inventory items, 6 general interference items, and the HN subscale adds 9 additional items assessing mucus in the mouth and throat, difficulty swallowing/chewing, choking/coughing, difficulty with voice/speech, skin pain/burning/rash, constipation, problems with tasting food, mouth/throat sores, and problems with teeth or gums. Scores for the subscales (general, interference, HN) are averaged so that a score is obtained from 0-10 for each subscale. The mean change in quality of life is calculated as the average scores at 6 weeks minus the average of the scores at baseline. Therefore a positive value represents a worsened quality of life and a negative value is an improvement in quality of life."|Mean value of [(MDASI-HN score at 6 weeks) - (MDASI-HN score at baseline)]||||units on a scale||95% Confidence Interval|Mean
2623488|NCT01930214|Secondary|Lesion Success|Lesion success is defined as success in facilitating stent delivery with a post-procedural result of <50% residual stenosis for a given lesion treated during the procedure without severe angiographic complications.|During the procedure|Subjects were enrolled based on Investigator assessment of calcium; however, all analyses were performed by core lab assessed calcium to ensure consistent methodology. Of the 350 subjects enrolled in the study, 346 had sufficient angiography for core lab stratification (133 none/mild, 99 moderate, and 114 severe).|||Percentage of Procedures|||Number
2625901|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||mEq/L||Standard Deviation|Mean
2623489|NCT01930214|Secondary|Procedural Success|Procedural success is defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE.|Participants were followed from baseline procedure through hospital discharge, an expected average of 24 hours|Subjects were enrolled based on Investigator assessment of calcium; however, all analyses were performed by core lab assessed calcium to ensure consistent methodology. Of the 350 subjects enrolled in the study, 346 had sufficient angiography for core lab stratification (133 none/mild, 99 moderate, and 114 severe).|||Percent of Procedures||95% Confidence Interval|Number
2623490|NCT01930214|Secondary|MACE at One (1) Year|"A Kaplan-Meier analysis was performed to determine the percent probability that a study participant experienced a major adverse cardiac event through 1 year.~1-year MACE is composed of:~Cardiac death~Myocardial Infarction (MI) - defined as a Creatine Kinase Myocardial-Band Isoenzyme (CK-MB) level greater than three (3) times the Upper Limit of Lab Normal (ULN) value with or without new pathologic Q wave~Target Vessel Revascularization (TVR) - defined as a revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure"|One (1) year post procedure|Subjects were enrolled based on Investigator assessment of calcium; however, all analyses were performed by core lab assessed calcium to ensure consistent methodology. Of the 350 subjects enrolled in the study, 346 had sufficient angiography for core lab stratification (133 none/mild, 99 moderate, and 114 severe).|||Percent probability of MACE||95% Confidence Interval|Number
2623491|NCT01930214|Primary|MACE at 30 Days|"A Kaplan-Meier analysis was performed to determine the percent probability that a study participant experienced a major adverse cardiac event through 30 days.~30-day MACE is composed of:~Cardiac death~Myocardial Infarction (MI) - defined as a Creatine Kinase Myocardial-Band Isoenzyme (CK-MB) level greater than three (3) times the Upper Limit of Lab Normal (ULN) value with or without new pathologic Q wave~Target Vessel Revascularization (TVR) - defined as a revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure"|30 days post procedure|Subjects were enrolled based on Investigator assessment of calcium; however, all analyses were performed by core lab assessed calcium to ensure consistent methodology. Of the 350 subjects enrolled in the study, 346 had sufficient angiography for core lab stratification (133 none/mild, 99 moderate, and 114 severe).|||Percent probability of MACE||95% Confidence Interval|Number
2623492|NCT01930188|Secondary|Subjects Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target (Yes/no)|Subjects who achieved HbA1c ≤6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE) target (yes/no) after week 56 weeks of treatment.|After 56 weeks treatment|Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin|||Subjects|||Number
2623493|NCT01930188|Secondary|Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline|Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin. The DTSQs questionnaire was used to assess subjects' treatment satisfaction. This questionnaire contained 8 components and evaluates the diabetes treatment (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings towards the treatment. The result presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction.|Week 0, week 56|Out of the 1225 subjects in FAS, 76 in semaglutide 0.5 mg arm, 76 in semaglutide 1.0 mg arm, and 113 in placebo arm had missing data for the endpoint. Missing data imputed from a mixed model for repeated measurements for treatment and country as fixed factors and baseline value as covariate, all nested within visit.|||Units on a scale||Standard Error|Least Squares Mean
2623494|NCT01930188|Secondary|Change in Systolic and Diastolic Blood Pressure From Baseline|Change in systolic and diastolic blood pressure from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin|Week 0, week 56|Missing data imputed from a mixed model for repeated measurements for treatment and country as fixed factors and baseline value as covariate, all nested within visit|||mmHg||Standard Error|Least Squares Mean
2623495|NCT01930188|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline|Change in fasting plasma glucose from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.|Week 0, week 56|Missing data imputed from a mixed model for repeated measurements for treatment and country as fixed factors and baseline value as covariate, all nested within visit|||mg/dL||Standard Error|Least Squares Mean
2623496|NCT01930188|Secondary|Change in Body Weight From Baseline|Change in body weight from baseline to week 56. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin.|Week 0, week 56|Missing data imputed from a mixed model for repeated measurements for treatment and country as fixed factors and baseline value as covariate, all nested within visit.|||kilograms||Standard Error|Least Squares Mean
2623497|NCT01930188|Primary|Change in HbA1c (Glycosylated Haemoglobin) From Baseline|Change in HbA1c from baseline until week 56.Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of randomised semaglutide or sitagliptin.|Week 0, week 56|Missing data imputed from a mixed model for repeated measurements for treatment and country as fixed factors and baseline value as covariate, all nested within visit.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
2623498|NCT01930162|Secondary|Incidence of Relapse-free Survival Within One Year|Patients are considered to have achieved relapse-free survival if they had not experienced either relapse or death (of any cause) at the end of the study.|1 year|Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant).|||Participants|||Number
2623499|NCT01930162|Secondary|Incidence of Overall Survival Within One Year|Overall survival is the proportion of patients who were alive at the end of the one year study period.|1 year|Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant).|||Participants|||Number
2623942|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Haematology: Haematocrit)|Change from baseline (within 4 weeks prior to week 0) in haematological parameter - haematocrit. Missing values were imputed using the LOCF method.|Baseline, week 208|SAS.|||Percentage of red blood cells||Standard Deviation|Mean
2623500|NCT01930162|Secondary|Incidence of Non-relapse Mortality (NRM) Within 100 Days and One Year|NRM includes all patients who died from any other cause except relapse of the underlying disease during the study duration.|1 year|Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant).|||Participants|||Number
2623501|NCT01930162|Secondary|Incidence of Neutrophil Recovery Within 42 Days|Engraftment is defined as the first of three consecutive days with ANC > 0.5 x 109/L.|42 days|Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant).|||Participants|||Number
2623502|NCT01930162|Primary|Absence of Graft Failure at Day 42|This endpoint was to study safety and tolerability of HSC835 as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.|42 days|Safety Analysis Set: The Safety analysis included all enrolled patients who were transplanted with HSC835 (any patient with a date for HSC835 transplant).|||Participants|||Number
2623503|NCT01930058|Secondary|Apparent Terminal Plasma Half-life (t½) of MK-8876|t½ is the time required for the maximum plasma drug concentration to reduce by 50% post-dose. Plasma t½ was determined on Day 7 of MK-8876 dosing.|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Day 7|All participants in Panels A, B, and E are included in the analysis.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2623504|NCT01930058|Secondary|Time to Maximum Plasma Concentration (Tmax) of MK-8876|Tmax is a measure of time required to reach the maximum plasma drug concentration post-dose. Plasma Tmax was calculated on Day 1 and Day 7 of MK-8876 dosing.|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7|All participants in Panels A, B, and E are included in the analysis.|||Hours||Full Range|Median
2623505|NCT01930058|Secondary|Trough Plasma Concentration (C24hr) of MK-8876|C24hr is a measure of the plasma drug concentration 24 hours post-dose (i.e., trough concentration). Plasma C24hr was determined on Day 1 and Day 7 of MK-8876 dosing.|24 hours post-dose on Days 1 and 7|All participants in Panels A, B, and E are included in the analysis.|||nM||Geometric Coefficient of Variation|Geometric Mean
2623506|NCT01930058|Secondary|Maximum Plasma Concentration (Cmax) of MK-8876|Cmax is a measure of the maximum plasma concentration of drug post-dose. Plasma Cmax was determined on Day 1 and Day 7 of MK-8876 dosing.|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7|All participants in Panels A, B, and E are included in the analysis.|||nM||Geometric Coefficient of Variation|Geometric Mean
2623507|NCT01930058|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (hr) Post-dose (AUC0-24 hr) of MK-8876|AUC0-24hr is a measure of the mean concentration of drug in plasma after dosing to 24 hr post-dose. Plasma AUC0-24hr was calculated on Day 1 and Day 7 of MK-8876 dosing.|Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose on Days 1 and 7|All participants in Panels A, B, and E are included in the analysis.|||µM*hr||Geometric Coefficient of Variation|Geometric Mean
2623508|NCT01930058|Primary|Mean Change From Baseline in HCV Viral Load|The mean change (log10) in HCV ribonucleic acid (RNA) from baseline to Day 7 was determined for each panel of participants.|Baseline and Day 7|All participants in Panels A, B, and E are included in the analysis.|||Log10 change||Standard Error|Mean
2623509|NCT01930045|Primary|Maximum Plasma Concentration (C Max) of Raltegravir in Part 2|Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean maximum plasma concentration.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period|The per-protocol population consisting of participants from the Raltegravir alone treatment group from Part 1, and the treatment groups from Part 2, who complied with the study procedure and had available data from at least one treatment.|||nM||95% Confidence Interval|Geometric Mean
2623510|NCT01930045|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 2|Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean area under the curve plasma concentration versus time.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period|The per-protocol population consisting of participants from the Raltegravir alone treatment group from Part 1, and the treatment groups from Part 2, who complied with the study procedure and had available data from at least one treatment.|||hr.nM||95% Confidence Interval|Geometric Mean
2623511|NCT01930045|Primary|Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 2|Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration.|12 hours after dosing on Day 1 of each period|The per-protocol population consisting of participants from the Raltegravir alone treatment group from Part 1, and the treatment groups from Part 2, who complied with the study procedure and had available data from at least one treatment.|||nM||95% Confidence Interval|Geometric Mean
2623512|NCT01930045|Primary|Maximum Plasma Concentration (C Max) of Raltegravir in Part 1|Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir, in order to determine the geometric mean maximum plasma concentration.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period|The per-protocol population consisting of participants from Part 1 only, who complied with the study procedure and had available data from at least one treatment. One participant did not complete one period of Maalox-4 hour-Raltegravir treatment, resulting in an n = 17.|||nM||95% Confidence Interval|Geometric Mean
2623513|NCT01930045|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC 0-12 Hrs) of Raltegravir in Part 1|Blood was drawn at time 0, and at various intervals up to 12 hours after dosing with raltegravir in order to determine the geometric mean area under the curve plasma concentration versus time.|Predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 of each period|The per-protocol population consisting of participants from Part 1 only, who complied with the study procedure and had available data from at least one treatment. One participant did not complete one period of Maalox-4 hour-Raltegravir treatment, resulting in an n = 17.|||hr.nM||95% Confidence Interval|Geometric Mean
2623576|NCT01929395|Secondary|Differences Between the Two Groups in the Volume of Breast Tissue Removed|The mean specimen volumes to be compared using t - statistics. The concordance between lesion volumes identified on the supine MRI images and the prone MRI images will be evaluated through correlation and regression analysis.|30 days from surgery||||ml||Standard Deviation|Mean
2623514|NCT01930045|Primary|Plasma Concentration of Raltegravir at 12 Hours (C 12 Hrs) in Part 1|Blood was drawn 12 hours after dosing with raltegravir in order to determine the geometric mean plasma concentration.|12 hours after dosing on Day 1 of each period|The per-protocol population consisting of participants from Part 1 only, who complied with the study procedure and had available data from at least one treatment. One participant did not complete one period of Maalox-4 hour-Raltegravir treatment, resulting in an n = 17.|||nM||95% Confidence Interval|Geometric Mean
2623515|NCT01929993|Primary|The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically.|Incomplete excision was considered when high-grade intraepithelial (CIN2-3) or microinvasive neoplasia was present in the endocervical limit of the excised specimen.|one month after the procedure|Any compromised margin.|||participants|||Number
2623516|NCT01929980|Primary|Number of Participants With Response|"For Autoimmune Hemolytic Anemia- At least 3 of 5 criteria should be met.~Stabilization of hemoglobin without transfusions by 2 weeks~Conversion of DAT from + to - by 6 weeks~Normalization of serum haptoglobin levels by 6 weeks~Normalization of indirect bilirubin levels by 6 weeks~Reduction in the frequency of transfusions by 50% by 4 weeks~For Autoimmune Neutropenia- At least 2 of 3 criteria should be met.~Stabilization of absolute neutrophil count by 2 weeks~Undetectable antineutrophil antibodies by 6 weeks~Reduction in GCSF dose by 50% by 6 weeks~For Autoimmune Thrombocytopenia- At least 2 of 3 criteria should be met.~Stabilization of platelet count without platelet transfusions by 2 weeks~Undetectable antiplatelet antibodies by 6 weeks~Reduction in the frequency of platelet transfusions by 50% from pre-bortezomib values by 6 weeks"|6 weeks||||participants|||Number
2623517|NCT01929889|Primary|Change in Social Cognition at 12 Weeks|"Facial Affect Perception Test that assesses the ability to accurately recognize facially expressed emotions as published by Smith et al 2014; Derntl et al., 2009. This scale ranges from 0-100 percent with a total of 30 trials. We examined the percent correct as the total number of correct responses divided by the total number of completed trials. There were no subscales. 100% accurate is the best outcome and 0% accurate is the worst outcome.~Cognitive Empathy Test that assesses the ability to accurately determine the emotional expression of another person as depicted in a static image of a social interaction as published by Smith et al 2014; Derntl et al., 2009. This scale ranges from 0-100 percent with a total of 60 trials. We examined the percent correct as the total number of correct responses divided by the total number of completed trials. There were no subscales. 100% accurate is the best outcome and 0% accurate is the worst outcome."|baseline and twelve weeks||||units on a scale||Standard Deviation|Mean
2623518|NCT01929876|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Itraconazole and Hydroxy-Itraconazole|AUC (0-24) = Area under the plasma concentration versus time curve from time zero (predose) to 24 hours postdose (0-24) of itraconazole and its metabolite hydroxy-itraconazole was assessed using a model independent approach.|Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24 hours post cobimetinib dose on Day 4|PK population|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2623519|NCT01929876|Secondary|Tmax of Itraconazole and Hydroxy-Itraconazole|Time to reach maximum observed plasma concentration of itraconazole and its metabolite hydroxy-itraconazole was assessed using a model independent approach.|Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|PK population|||hours||Full Range|Median
2623520|NCT01929876|Secondary|Cmax of Itraconazole and Hydroxy-Itraconazole|Maximum observed plasma concentration of itraconazole and its metabolite hydroxy-itraconazole was assessed using a model independent approach.|Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|PK population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2623521|NCT01929876|Secondary|Apparent Volume of Distribution (Vz/F) of Cobimetinib With and Without Itraconazole|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction of drug absorbed.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|"PK population. Number of Participants Analyzed indicates participants evaluable for this outcome measure and n signifies participants evaluable for specified category."|||liter (L)||Geometric Coefficient of Variation|Geometric Mean
2623522|NCT01929876|Secondary|Apparent Clearance (CL/F) of Cobimetinib With and Without Itraconazole|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|"PK population. Number of Participants Analyzed indicates participants evaluable for this outcome measure and n signifies participants evaluable for specified category."|||liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2623523|NCT01929876|Secondary|Plasma Half-Life (t1/2) of Cobimetinib With and Without Itraconazole|Plasma half-life is the time measured for the plasma concentration to decrease by one half.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|"PK population. Number of Participants Analyzed indicates participants evaluable for this outcome measure and n signifies participants evaluable for specified category."|||hours||Full Range|Median
2623524|NCT01929876|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Cobimetinib With and Without Itraconazole|AUC (0-t) = Area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (0-t) of cobimetinib with and without itraconazole was assessed. It was calculated using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|PK population|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2623525|NCT01929876|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Cobimetinib With and Without Itraconazole|Time to reach maximum observed plasma concentration of cobimetinib with and without itraconazole was assessed using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|PK population|||hours||Full Range|Median
2623526|NCT01929876|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of Cobimetinib With and Without Itraconazole|AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf) of cobimetinib with and without itraconazole, assessed using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|"PK population. Number of Participants Analyzed indicates participants evaluable for this outcome measure and n signifies participants evaluable for specified category."|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2623527|NCT01929876|Primary|Maximum Observed Plasma Concentration (Cmax) of Cobimetinib With and Without Itraconazole|Maximum observed plasma concentration of cobimetinib with and without itraconazole was assessed using a model independent approach.|Period 1: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192 hours postdose on Day 1; Period 2: Predose (0 hour), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 144, 192, 240 hours post cobimetinib dose on Day 4|Pharmacokinetic (PK) population consisted of all participants who received at least 1 dose of cobimetinib and had evaluable PK data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2623528|NCT01929863|Secondary|Median Time to Observed Peak Plasma Concentration (Tmax) When Co-dosed With GSK2330672 or Placebo on Day 7|Tmax is defined as the time at which Cmax is observed, determined directly from the raw concentration-time data. Blood samples were collected at 0 h (pre-dose within 15 min of dose and began eating breakfast immediately after taking study drug and finished eating in 15 min), 0.25 h, 0.50 h, 1 h, 2 h, 3 h, 4 h (pre-lunch), 5 h, 5.5 h, 6 h, 8 h and 10 h (pre-dinner) on Day 7.|Pre-dose (0 h), 0.25 h, 0.50 h, 1 h, 2 h, 3 h, 4 h (pre-lunch), 5 h, 5.5 h, 6 h, 8 h and 10 h (pre-dinner) on Day 7 of each treatment period|PK Population. Only those participants available at the specified time points were analyzed.|||h||Full Range|Median
2623529|NCT01929863|Secondary|Maximum Plasma Concentration of Metformin (Cmax) in Presence of GSK2330672 or Placebo on Day 7|Cmax is defined as the first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data Blood samples were collected at 0 h (pre-dose within 15 min of dose and began eating breakfast immediately after taking study drug and finished eating in 15 min), 0.25 h, 0.50 h, 1 h, 2 h, 3 h, 4 h (pre-lunch), 5 h, 5.5 h, 6 h, 8 h and 10 h (pre-dinner) on Day 7. Analysis was done using a mixed effects model with fixed effect terms for treatment, period, and sequence. Participant within sequence was fitted as a random effect in the model.|Pre-dose (0 h), 0.25 h, 0.50 h, 1 h, 2 h, 3 h, 4 h (pre-lunch), 5 h, 5.5 h, 6 h, 8 h and 10 h (pre-dinner) on Day 7 of each treatment period|PK Population. Only those participants available at the specified time points were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2623530|NCT01929863|Secondary|AUC From Time 0 to 10 h (AUC 0-10 h) of Metformin in Presence of GSK2330672 or Placebo on Day 7|AUC(0-10) for metformin when co-dosed with GSK2330672 or placebo is defined as the the area under the plasma concentration-time curve from time 0 to 10 h. It was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at 0 h (pre-dose within 15 min of dose and began eating breakfast immediately after taking study drug and finished eating in 15 min), 0.25 h, 0.50 h, 1 h, 2 h, 3 h, 4 h (pre-lunch), 5 h, 5.5 h, 6 h, 8 h and 10 h (pre-dinner) on Day 7. Analysis was done using a mixed effects model with fixed effect terms for treatment, period, and sequence. Participant within sequence was fitted as a random effect in the model.|Pre-dose (0 h), 0.25 h, 0.50 h, 1 h, 2 h, 3 h, 4 h (pre-lunch), 5 h, 5.5 h, 6 h, 8 h and 10 h (pre-dinner) on Day 7 of each treatment period|Pharmacokinetic (PK) Population was defined as participants from the safety population who had plasma metformin and or GSK2330672 PK parameter estimates from any portion of the study. Only those participants available at the specified time points were analyzed.|||Nanogram (ng)*h/mL||Geometric Coefficient of Variation|Geometric Mean
2623531|NCT01929863|Secondary|Maximum and Weighted Mean Change From Baseline in Plasma Glucose Concentrations Over a 24 Hour (h) Period on Day 7|Baseline was defined as the time matched assessment done on Day -1. Change from baseline was calculated by subtracting the baseline (Day -1) time matched values from the post-baseline value (Day 8). Data is reported for fasting glucose level and for weighted mean and maximum values for fasting, 0-4 h, 4-10 h, 10-14 h and 0-24 h. Area under the curve (AUC) with respect to these time interval was calculated using the linear trapezoidal rule by the sum of the areas between each chronological pair of assessments (using observed times). The weighted mean was then determined by dividing the AUC by the observed length of the collection interval (time of last assessment - time of first assessment in h). Analysis was done using analysis of covariance (ANCOVA) model where, change from baseline was summation of baseline, period, sequence and treatment. Participants were fitted as a random effect.|Baseline (Day -1) and Day 7 of each treatment period|Safety Population. Only those participants available at the specified time points were analyzed.|||mg/deciliter||Standard Deviation|Mean
2623532|NCT01929863|Primary|Mean Change From Baseline in Overall Gastrointestinal Symptom Rating Scale (GSRS) Scores|The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the GSRS. The GSRS is a 15-item related to abdominal pain, reflux, indigestion, diarrhea and constipation syndromes, self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Overall GSRS is the mean of questions 1-15 and range from 1 to 7, with lower scores indicating a better quality of life with respect to gastrointestinal symptoms. Baseline was defined as the assessment done on Day -1. Change from baseline was calculated by subtracting the baseline (Day -1) values from the post-baseline value (Day 8).|Baseline (Day -1) and Day 8 of each treatment period|Safety Population.|||Score on scale||Standard Deviation|Mean
2623943|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Haematology: Haemoglobin)|Change from baseline (within 4 weeks prior to week 0) in haematological parameter - haemoglobin. Missing values were imputed using the LOCF method.|Baseline, week 208|SAS.|||mmol/L||Standard Deviation|Mean
2623533|NCT01929863|Primary|Number of Participants in Each Category of BSFR Across Day 1 to 7|The BSFR Scale assessed stool quality using a 7-point scale, where 1=separate hard lumps like nuts (difficult to pass) and 7 = watery, no solid pieces (entirely liquid). Bristol Stool Form Scale Rating: 1=separate hard lumps, like nuts, 2=sausage shaped but lumpy, 3=like a sausage or snake but with cracks on its surface, 4=like a sausage or snake, smooth and soft, 5=soft blobs with clear cut edges, 6=fluffy pieces with ragged edges, a mushy stool, 7=watery, no solid pieces. Data is reported for number of events in participants with each category of BSFR scale across Day 1 to 7 post morning dose.|Day 1 to 7 of each treatment period|Safety Population.|||Participants|||Count of Participants
2623534|NCT01929863|Primary|Number of Events of Stool or Bowel Movements of Participants Using Bristol Stool Form Rating (BSFR) Scale Across Day 1 to 7|The BSFR Scale assessed stool quality using a 7-point scale, where 1=separate hard lumps like nuts (difficult to pass) and 7=watery, no solid pieces (entirely liquid). Bristol Stool Form Scale Rating: 1=separate hard lumps, like nuts, 2=sausage shaped but lumpy, 3=like a sausage or snake but with cracks on its surface, 4=like a sausage or snake, smooth and soft, 5=soft blobs with clear cut edges, 6=fluffy pieces with ragged edges, a mushy stool, 7=watery, no solid pieces. Data is reported for number of events in participants with each category of BSFR scale across Day 1 to 7 post morning dose.|Day 1 to 7 of each treatment period|Safety Population.|||Number of events|||Number
2623535|NCT01929863|Primary|Number of Participants With Abnormal (Clinically Significant or Not Clinically Significant) Findings in 12-lead Electrocardiogram (ECG) at Any Time Post Baseline|12-lead ECG assessments were obtained pre-dose at Day 1, Day 3, Day 8 (before discharge) and Follow-up. The assessments were done using an ECG machine that automatically calculated the heart rate and measures PQ, QRS, QT, and QTc(B) intervals. Abnormal ECG findings (clinically significant or not clinically significant) were categorized. The abnormal PCI range for T2DM participants include QTc interval of >450 to <=480 milliseconds (msec) and increase from Baseline QTc interval of > 30 to <=60 msec, PR interval <110 and >220 msec and QRS interval <75 and >110 msec. ECG abnormalities were categorized as clinically significant or not clinically significant based on PCI criteria and judgment of the investigator. Baseline was defined as the mean of three replicate assessments at pre-dose on Day 1.|Up to Follow-up (up to 53 days)|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2623536|NCT01929863|Primary|Number of Participants With Vital Sign Values of PCI at Any Time Post Baseline|Vital signs assessment included heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP). Assessments were completed at pre morning dose on Day 1 (Baseline), Day 3, Day 8 (before discharge) and Follow-up. Criteria for vital sign values meeting PCI for Type 2 diabetes mellitus (T2DM) included: SBP <85 and >160 millimeters of mercury (mmHg), DBP <45 and >100 mmHg and HR <40 and >110 beats per minute (bpm). Only those parameters for which at least one value of PCI was reported are summarized.|Up to Follow-up (up to 53 days)|Safety Population.|||Participants|||Count of Participants
2623537|NCT01929863|Primary|Number of Participants With Abnormal Results for Fecal Occult Blood Test|The assessment of fecal occult blood was done on Day 8. Stool sample was obtained any time after dosing on Day 7.|Day 8 of both treatment periods|Safety Population.|||Participants|||Count of Participants
2623538|NCT01929863|Primary|Mean Specific Gravity of Urine at Any Visit Post Baseline|Urine specific gravity is a laboratory test that shows the concentration of all chemical particles in the urine. The assessments were done at Day -1, Day 3, Day 8 and Follow-up under fasting condition. Baseline was the assessment done on Day -1 (pre dose).|Up to Follow-up (up to 53 days)|Safety Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2623539|NCT01929863|Primary|Number of Participants With Abnormal Values of Urine Dipstic Analysis of Occult Blood, Glucose, Ketones and Proteins at Any Visit Post Baseline|The assessments were done at Day -1, Day 3, Day 8 and Follow-up under fasting condition for urine dipstic analysis of occult blood, glucose, ketones and proteins. Baseline was the assessment done on Day -1 (pre dose). The participants were categorized with results of 1+, 2+, 3+ and trace. Only those parameters for which at least one value of these categories reported are summarized.|Up to Follow-up (up to 53 days)|Safety population.|||Participants|||Count of Participants
2623540|NCT01929863|Primary|Number of Participants With Abnormal Values of Urine Microscopic Analysis of Bacteria, Hyaline Casts (Semi-quantitive), RBC, Squamous Epithelial Cells and WBC at Any Time Post Baseline|The assessments were done at Day -1, Day 3, Day 8 and Follow-up under fasting condition for microscopic analysis of bacteria, hyaline casts (semi-quantitive), RBC, squamous epithelial cells and WBC. Baseline was the assessment done on Day -1 (pre dose). The participants were categorized as 0-5, 6-10, 10-20, moderate, few and many. Only those parameters for which at least one value of these categories reported are summarized.|Up to Follow-up (up to 53 days)|Safety Population.|||Participants|||Count of Participants
2623541|NCT01929863|Primary|Number of Participants With the Indicated Haematology Values of PCI at Any Time Post Baseline|The assessments were done at Day -1, Day 3, Day 8 and Follow-up under fasting condition. The following laboratory parameters of clinical haematology were analyzed: platelet count, red blood cells (RBC) count, absolute white blood cells (WBC) count, reticulocyte count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was the assessment done on Day -1 (pre dose). Only those parameters for which at least one value of PCI was reported are summarized. Data is reported for participants with high WBC counts PCI, where the PCI value for T2DM participants was (relative low : 0.5 multiplier of lower limit of normal [LLN]; relative high : 1.82 multiplier of upper limit of normal [LLN]; where normal range was 3.8 - 10.8 giga cells per liter (GI/L).|Up to Follow-up (up to 53 days)|Safety Population.|||Participants|||Count of Participants
2623552|NCT01929759|Primary|Change in Neurometabolites Based on Magnetic Resonance Spectroscopy (MRS)|Assess the change in levels of neuro-metabolites measured by MRS from week 0 (before switching to the efavirenz-based therapy) and then at week 8 (after completing 9 weeks of integrase-inhibitor based regimen with Stribild). Two areas of the brain: 1) posterior cingulate gyrus and 2) anterior cingulate will be assessed for the levels of brain Cr, GABA and GLU.|week 0 to week 8|The arbitrary units are expressed as the output from MRS software. While similar to concentration (mM) due to assumptions in the software, it is best expressed as arbitrary units for comparison from week 0 to week 8.|||arbitrary units||Standard Deviation|Mean
2623542|NCT01929863|Primary|Number of Participants With the Indicated Clinical Chemistry Values of Potential Clinical Importance (PCI) at Any Time Post Baseline|The assessments were done at Day -1, Day 3, Day 8 and Follow-up under fasting condition. The following laboratory parameters of clinical chemistry were analyzed: blood urea nitrogen (BUN), creatinine, fasting triglycerides (TGs), total cholesterol, low-density lipoprotein cholesterol (LDLc), high-density lipoprotein cholesterol (HDLc), sodium, potassium, chloride, total bicarbonate, calcium, aspartate aminotransferase (AST), ALT, gamma glutamyltransferase (GGT), alkaline phosphatase, total and direct bilirubin, uric acid, albumin and total protein. Baseline was the assessment done on Day -1 (pre dose). Only those parameters for which at least one value of PCI was reported are summarized. Data is reported for participants with high glucose PCI, where the PCI value for T2DM participants was ( low < 3.8857 millimole per liter (mmol/L); high > 15 mmol/L; normal range was 3.61 - 5.5 mmol/L).|Up to Follow-up (up to 53 days)|Safety Population.|||Participants|||Count of Participants
2623543|NCT01929863|Primary|Number of Participants With at Least One Adverse Event (AE), Serious Adverse Event (SAE) or Death|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase (ALT) >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5.|Up to Follow-up (up to 53 days)|Safety Population was defined as all participants enrolled into the study who have received at least one dose of study drug (including metformin, GSK2330672, and matching placebo. One participant withdrew consent after taking period 1 study treatment of placebo + GSK2330672.|||Participants|||Count of Participants
2623544|NCT01929759|Secondary|Effect of EFV and Its Metabolites|Level of EFV (efavirenz) in Atripla and its two known metabolites known to cause cerebral side effects, 7-hydroxy (OH) EFV and 8-OH EFV, were measured in the plasma prior to switch off Atripla and after 8 weeks of RAL-based regimen (no EFV).|week 0 and week 8||||participants|||Number
2623545|NCT01929759|Secondary|Markers of Immune Activation|Change in markers of immune activation and inflammation associated with change to Stibild: sCD14, IP-10,sCD163, IL-6)|week 0 and week 8|Inflammatory markers were measured pre- and post-drug switch from Atripla to Stibild.|||pg/ML||Standard Deviation|Mean
2623546|NCT01929759|Secondary|ART Regimen Preference|Evaluate patient preference in ART regimen (Atripla, EFV/FTC/TDF versus EVG/COBI/FTC/TDF) through a self-administered questionnaire.|week 0 and week 8|Patients were surveyed at the end of the study with a single question regarding their ART preference. They are asked to pick one of the 3 answers: 1. prefer Atripla, 2. prefer the new drug (Stribild) or 3. no preference. The number of patients who would like to switch to study drug, Stribild, are indicated by the percentage.|||Participants|||Count of Participants
2623547|NCT01929759|Secondary|Sleep Quality|Assess for changes in sleep pattern and quality prior to and after switching off EFV-based regimen through a self-administered Pittsburg Sleep Quality Index (PSQI). Measure consists of 19 items with each weighted on 0-3 scale and the sum produces a total score, which ranges from 0-21. The lower the score the healthier the sleep quality; minimum Score = 0 (better); maximum Score = 21 (worse).|week 0 and week 8||||units on a scale||Standard Deviation|Mean
2623548|NCT01929759|Secondary|Fasting Lipid Profile|Measure the change in fasting lipid panel prior to and after switching off EFV-based regimen.|8 weeks|Change in fasting lipid profile was measured: total cholesterol, HDL and LDL levels.|||mg/dl||Standard Deviation|Mean
2623549|NCT01929759|Secondary|Neurocognitive Changes|"Assess for changes in cognitive and affective function prior to and after switching off EFV-based regimen. Indexes used to access neurocognitive changes included:~Wechsler Adult Intelligence Scale (WAIS-R) Digital Symbol Substitution Test: sensitive to brain damage, dementia, age and depressive changes. Range of 0-100, the higher the score the better the person's performance~Hamilton Rating Scale for Depression (HAMD): Measure of depression. Score of 0-7 is normal, score of >20 is moderate/severe depression~Depression Anxiety Stress Scale (DASS-21) the lower the score, the less severe depression, anxiety and stress. Scale range of 0-63~Frontal Systems Behavior Scale (FRSBE): Increased score indicates greater behavioral impairment associated with frontal systems, range 37.2 to 186~6. Spielberger state trait anxiety inventory (STAI): the higher the score the greater then anxiety level, range of 20 to 80."|week 0 and week 8|"Several Indexes were used to access neurocognitive changes: WAIS, HAMD, FRSBE, DASS-21, STAI.~Participants were given these tests prior to and after drug switch."|||units on a scale||Standard Deviation|Mean
2623550|NCT01929759|Secondary|Change in Other Neurometabolite Measured by MRS Between Week 0 and Week 8|Use MRS to evaluate a fuller panel of known neurometabolites (in addition to the primary endpoints) between week 0 and week 8 to identify prominent and significant changes associated with EFV use.|week 0 to week 8|The arbitrary units are expressed as the output from MRS software. While similar to concentration (mM) due to assumptions in the software, it is best expressed as arbitrary units for comparison from week 0 to week 8.|||arbitrary units||Standard Deviation|Mean
2623551|NCT01929759|Primary|Neural Activation Networks Using Functional Magnetic Resonance Imaging (fMRI)|Assess changes in neural activation correlated with affective disturbances associated with efavirenz-based therapy using fMRI employing an Emotional Word/Go-NoGo task paradigm that probes affective symptomatologies typical with EFV use, specifically anxiety/dysphoria and affective dysregulation and their association with changes in cognitive function. Four brain regions of interests (ROIs) are specified to show the differential frontal-limbic activation patterns in the task-evoked neural responses to the 3 linear contrasts of Pre-switch / Post-switch / Pre- vs. Post-switch: [Negative Word vs. Neutral Word] x [No-Go Trial Block vs. Go Trial Block]: anterior Frontal Pole (aFP), posterior Cingulate Gyrus (pCG), dorsal anterior Cingulate Gyrus (daCG), Left Hippocampus (LHC). A linear mixed-effects model is utilized to examine the effect sizes of the key Regimen/Condition contrasts, with the Subject factor as the random-effect and Age incorporated as a co-variate of no interest.|week 0 and week 8|8 of 10 enrolled patients passed QA testing to be included in the final analyses. The 3 linear contrasts of Pre-switch/Post-switch/Pre- vs. Post-switch: [Neg vs.Neu] x [No-Go vs. Go] are reported as z-score (standardized effect size measures with SD=1). Z-score is obtained for each subject, group Z-score is obtained via a mixed-effects model.|||z-score|||Number
2623553|NCT01929707|Secondary|PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3050258||Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Day 7 postdose; Period 2: predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose|All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate AUC(0-∞). Participants were analyzed based on the treatment they received.|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2623554|NCT01929707|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3050258||Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours (h) postdose and Day 7 postdose; Period 2: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose.|All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate Cmax. Participants were analyzed based on the treatment they received.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2623555|NCT01929707|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|Data presented are the number of participants who experienced SAEs which were considered to be related to study treatment by the investigator while on treatment and during the follow-up. Summaries of SAEs and other non-serious adverse events (AEs), regardless of causality, are located in the Reported Adverse Events module.|Baseline up to 21 days postdose|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2623556|NCT01929681|Secondary|Rate of Change Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale|"PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item right now on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure uses the 10 item positive affect subscale. This outcome measure is the least squares fit of a linear coefficient to the three pretreatment scores for the three treatment days"|Over 3 days of treatment|Subjects completing 3 treatments and 1 visit|||units on a scale||Standard Error|Mean
2623557|NCT01929681|Secondary|Rate of Change Over 3 Treatments: Montgomery-Asberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating scale assesses 10 symptom areas of depression during an interview. Each of the 10 items received a score ranging from 0 to 6. The scale has a range of 0-60 for the reported total. A higher score indicates increased depression for all items and for the total. This outcome measure is the least squares fit of a linear coefficient to the three pretreatment scores for the three treatment days|Over 3 days of treatment|Subjects completing 3 treatments and 1 visit|||units on a scale||Standard Error|Mean
2623558|NCT01929681|Secondary|Rate of of Change in Daily Improvement Over 3 Treatments: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale|"PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item right now on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure uses the 10 item positive affect subscale. This outcome measure is the least squares fit of a linear coefficient to the three post (<30min oost treatment) minus pre (<30min pre treatment) score differences for the three treatment days"|Over 3 days of treatment|Subjects completing 3 treatments and 1 visit|||units on a scale||Standard Error|Mean
2623559|NCT01929681|Primary|Change Over First Treatment: Positive and Negative Affect Schedule (PANAS) Positive Items Subscale|"PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item right now on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure is change in the 10 item positive affect subscale. This outcome measure is the difference between the scale administered immediately (<30min) prior to the first treatment and immediately after (<30min) the first treatment."|90 minutes; change immediately (<30min) prior to the first treatment and immediately after (<30min) the first treatment.|subjects completing 3 treatment visits and 1 followup visit|||units on a scale||Standard Deviation|Mean
2623560|NCT01929681|Primary|Long Term Change: Montgomery-Åsberg Depression Rating Scale (MADRS)|The Montgomery-Asberg Depression Rating scale assesses 10 symptom areas of depression during an interview. Each of the 10 items received a score ranging from 0 to 6. The scale has a range of 0-60 for the reported total. A higher score indicates increased depression for all items and for the total. This outcome measure is the change from pretreatment baseline acquired at the screening visit to a follow-up visit 7 days after the first treatment.|Variable based on screening visit schedule, > 2 weeks.|Subjects completing 3 treatments and 1 visit|||units on a scale||Standard Deviation|Mean
2623561|NCT01929473|Secondary|Infection Risk Factors Including Family Numbers, Living Space, With or Without a Cough Patient in the Surroundings, Medical History and Hospitalization|Questionnaire|365 day|||||||
2623562|NCT01929473|Secondary|Antibodies of Varicella, Mumps and Rubella|Questionnaire|0 day|||||||
2623563|NCT01929473|Secondary|Incidence of Pertussis|Questionnaire|0 day|||||||
2623564|NCT01929473|Primary|IgG|Seroincidence of pertussis estimated by the elevation of Ig-G-PT in paired sera(0day, 365day).|0 day, 365 day (2 points)||||EU/mL(log transformed)||Standard Deviation|Mean
2623565|NCT01929460|Secondary|Median Cyst Fluid Amylase|Median cyst fluid amylase for classification of mucinous cystic lesions|six weeks||||Units/L||Inter-Quartile Range|Median
2623566|NCT01929460|Secondary|Median Cyst Fluid Carcinoembryonic Antigen (CEA)|Median cyst fluid carcinoembryonic antigen (CEA) for classification of mucinous cystic lesions|six weeks||||ng/mL||Inter-Quartile Range|Median
2623567|NCT01929460|Secondary|Mean Cyst Fluid Amylase|Mean cyst fluid amylase for classification of mucinous cystic lesions|six weeks||||Units/L||Full Range|Mean
2623577|NCT01929395|Primary|To Determine Whether the Addition of Supine MRI to Conventional Imaging With Mammography and Prone MRI Results in a Lower Positive Margin Rate in Patients Undergoing Breast-conserving Surgery.|The primary analysis consists of computing the positive margin rate observed in the two groups and comparing them with a chi-squared test and finally comparing the proportion of patients with positive margins in the two groups based on study criteria.|30 days from surgery||||Participants|||Count of Participants
2623578|NCT01929395|Primary|The Mean Distance Between the Image-defined and Palpation-defined Edges of the Tumor.|Mean calculated from differences in precise distances from the nipple to the superior, inferior, medial and lateral edges of the tumor as determined from the adjusted MRI images and conventional MRI.|From baseline MRI to intraoperative measurements: 30 days||||mm||Full Range|Mean
2623579|NCT01929317|Secondary|"Change From Baseline in Percentage of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Par. were asked to record the duration of their on  periods and asleep in diary cards every day. Percentage of awake time spent On without troublesome dyskinesias is defined as sum of two days on time without troublesome dyskinesias [On time minus On time with troublesome dyskinesias] (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent On without troublesome dyskinesias) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent On without troublesome dyskinesias). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||percentage of awake time spent on||Standard Deviation|Mean
2623580|NCT01929317|Secondary|"Change From Baseline in Percentage of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their on  periods and asleep in diary cards every day. Percentage of awake time spent on is defined as sum of two days on time (hours) divided by sum of two days awake time (hours) and multiplified by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent on) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent on). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing the first observed value post week 13 was used as a Baseline.The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||percentage of awake time spent on||Standard Deviation|Mean
2623581|NCT01929317|Secondary|"Change From Baseline in Actual Hours of Awake Time Spent On Without Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their on  periods and asleep in diary cards every day. Change from Baseline in awake time spent On without troublesome dyskinesias (actual hours) is calculated as [awake time spent On minus awake time spent On with troublesome dyskinesias] (hours) at visit minus [awake time spent On minus awake time spent On with troublesome dyskinesias] (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data"|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||hours||Standard Deviation|Mean
2623582|NCT01929317|Secondary|"Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their off  periods and asleep in diary cards every day. Change from Baseline in awake time spent On(actual hours) is calculated as awake time spent On (hours) at the week 17, 21, 25, 37, 49 and 52 value minus awake time spent On (hours) at Baseline. Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||hours||Standard Deviation|Mean
2623601|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population|||Percent change||Standard Deviation|Mean
2623583|NCT01929317|Secondary|"Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their off  periods and asleep in diary cards every day. Percentage of awake time spent off is defined as sum of two days off time (hours) divided by sum of two days awake time (hours) and multiplied by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent off) from week 17, 21, 25, 37, 49 and 52 value (percentage of awake time spent off). Baseline is defined as the value at Week 13, If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline. The analyses for Long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||percentage of awake time spent off||Standard Deviation|Mean
2623584|NCT01929317|Secondary|"Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct in Long Term Phase"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their off  periods and asleep in diary cards every day. Change from Baseline was calculated by subtracting the Baseline value (actual hours of awake time spent off) from the week 17, 21, 25, 37, 49 and 52 value (proportion of awake time spent off). Baseline is defined as the value at Week 13. If the value evaluated at week 13 was missing then first observed value post week 13 was used as a Baseline.The analyses for long term phase was performed using the OC data. In the OC data, no imputation was carried for any missing data"|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population who received L-dopa adjunct in Long term phase. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||hours||Standard Deviation|Mean
2623585|NCT01929317|Secondary|Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in Long Term Phase.|The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 17, 21, 25, 37, 49 and 52,are presented using OC data. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The OC (observed Case) dataset was defined as the dataset consisting of observed data without any missing data imputation.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||Participants|||Number
2623586|NCT01929317|Secondary|Number of Participants Remaining in the Study||From the start of the study medication (Week 0) until Week 52|Safety Population 2 (SP2) compraised of all participants who included in SP1 (receive at least one dose of medication in Dose Increase Effect Verification Phase) and shifted to Long-term Phase and received at least one dose of medication in Long-term Phase.|||Participants|||Number
2623587|NCT01929317|Secondary|Number of Participants With an Improvement (Responder) in the Clinical Global Impression (CGI) Global Improvement Scale at Week 12|The CGI global improvement scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Scores on the scale range from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse). Participants with a CGI global improvement score of <=2 (representing much improved or very much improved) were considered to be moderate improvement (responder). The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Week 12|FAS1 Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2623588|NCT01929317|Secondary|"Change From Baseline in Actual Hours of Awake Time Spent OnWithout Troublesome Dyskinesias at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their off  periods and asleep in diary cards every day. Change from Baseline in awake time spent On without troublesome dyskinesias (actual hours) is calculated as [awake time spent On minus awake time spent On with troublesome dyskinesias] (hours) at visit minus [awake time spent On minus awake time spent On with troublesome dyskinesias] (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.|||hours||Standard Deviation|Mean
2623617|NCT01929226|Secondary|Terminal Half-life (t1/2)|Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71.|In addition, for several participants, certain PK parameter values were set to missing for the purposes of calculating descriptive statistics in the primary analysis, in accordance with the SAP. ETI-204 t1/2 values were not reported for 6 participants as they were greater than 50% of the 71-day sample collection interval.|||days||Standard Deviation|Mean
2623589|NCT01929317|Secondary|"Change From Baseline in Actual Hours of Awake Time Spent On at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"|"On state is defined as the state at which PD symptoms are well controlled by the drug. Participants were asked to record the duration of their off  periods and asleep in diary cards every day. Change from Baseline in awake time spent On(actual hours) is calculated as awake time spent On (hours) at the indicated visit minus awake time spent On (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.|||hours||Standard Deviation|Mean
2623590|NCT01929317|Secondary|"Change From Baseline in the Percentage of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their off  periods and asleep in diary cards every day. Percentage of awake time spent off is defined as sum of two days off time (hours) divided by sum of two days awake time (hours) and multiplied by 100. Change from Baseline was calculated by subtracting the Baseline value (percentage of awake time spent off) from the post Baseline value (percentage of awake time spent off). Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed.|||percentage of awake time spent off||Standard Deviation|Mean
2623591|NCT01929317|Secondary|"Change From Baseline in the Actual Hours of Awake Time Spent Off at the Indicated Visits Only in Participants Who Received L-dopa Adjunct"|"Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Participants were asked to record the duration of their off  periods and asleep in diary cards every day. Change from Baseline in awake time spent Off(actual hours) is calculated as awake time spent Off (hours) at the indicated visit minus awake time spent Off (hours) at Baseline. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed.|||hours||Standard Deviation|Mean
2623592|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long-term Phase|"The Japanese UPDRS assesses the status of PD participants objectively. Part 4 evaluates complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for No and 1 for Yes. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||Percent change||Standard Deviation|Mean
2623593|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Long Term Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||Percent change||Standard Deviation|Mean
2623594|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long-term Phase|"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||Percent change||Standard Deviation|Mean
2623828|NCT01928615|Secondary|Percentage of Participants Preferring Each Injection Site|Participants were asked which of the 2 injection sites was their preferred site at the end of Cycle 14.|End of Cycle 14 (Week 42)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.~Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."||||||
2623595|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long Term Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||Percent change||Standard Deviation|Mean
2623596|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Long Term Phase|"The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for No and 1 for Yes. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||Scores on a scale||Standard Deviation|Mean
2623597|NCT01929317|Secondary|Mean Change From Baseline in UPDRS Part 3 Total Score at the Indicated Visits for Long Term Phase|The Japanese UPDRS assesses the status of PD participants objectively. Part 3 evaluates motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49, 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||Scores on a scale||Standard Deviation|Mean
2623598|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Long Term Phase|"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value at Week 13. If the value at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations."|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||Scores on a scale||Standard Deviation|Mean
2623599|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Long-term Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms.Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 13. If the value evaluated at Week 13 was missing, then first observed value post Week 13 was used as Baseline. The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data. Full Analysis Set 2 (FAS2) Population comprised of all participants in the FAS1 and shifted to Long-term Phase, excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.|Baseline (Week 13), Weeks 17, 21, 25, 37, 49 and 52|FAS2 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS2 population.|||Scores on a scale||Standard Deviation|Mean
2623600|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|"The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for No and 1 for Yes. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2623602|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase|"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.|||Percent change||Standard Deviation|Mean
2623603|NCT01929317|Secondary|Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2623604|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|"The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for No and 1 for Yes. The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population|||Scores on a scale||Standard Deviation|Mean
2623605|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase|"The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluated activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. On state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations."|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.|||Scores on a scale||Standard Deviation|Mean
2623606|NCT01929317|Secondary|Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assesses the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at the planned visit.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population|||Scores on a scale||Standard Deviation|Mean
2623607|NCT01929317|Secondary|Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase|The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 2, 4, 6, 8, and 12 are presented using LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.|Baseline, Weeks, 2, 4, 6, 8 and 12|FAS1 Population|||Participants|||Number
2623630|NCT01929109|Primary|Pharmacokinetics (PK): Area Under the Concentration Curve From Time Zero to Infinity (AUC 0-∞) of LY2409021||Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose|All participants in Groups 1-4 who received at least 1 dose of study drug and had evaluable PK data, excluding one participant (discontinued for a protocol violation). No efficacy or safety data for this participant are included in results.|||Nanogram x hour per milliliter(ng•h/mL)||Geometric Coefficient of Variation|Geometric Mean
2623608|NCT01929317|Secondary|Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits|The Japanese Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.|Baseline, Weeks, 2, 4, 6, 8 and 12|Full Analysis Set 1 (FAS1) Population: all participants excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.|||Scores on a scale||Standard Deviation|Mean
2623609|NCT01929317|Primary|Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at Week 12 in the CR High-dose Group|The Japanese Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.|Baseline and Week 12|Full Analysis Set 1 (FAS1) Population: all participants excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.|||Scores on a scale||Standard Deviation|Mean
2623610|NCT01929291|Primary|Number of Subjects With Serious Adverse Events (SAEs)|An SAE was defined as any AE that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or that was a congenital anomaly/birth defect in the offspring of a study subject.|During the 30-day (Day 0 - Day 29) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the study vaccine.|||Participants|||Count of Participants
2623611|NCT01929291|Primary|Number of Expected AEs.|Expected AEs were defined as an adverse event that was expected from the subject during the post-vaccination follow-up period as described in the locally approved Prescribing Information in Korea.|During the 30-day (Day 0 - Day 29) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the study vaccine.|||Events|||Number
2623612|NCT01929291|Primary|Number of Unexpected Adverse Events (AEs)|Unexpected AEs were defined as adverse events that are not reflected in the approved Prescribing Information in Korea.|During the 30-day (Day 0 - Day 29) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received the study vaccine.|||Events|||Number
2623613|NCT01929226|Secondary|Number of Participants With Anti-ETI-204 Antibodies|Serum anti-ETI-204 antibody titers were determined for all subjects in the safety population. Blood samples were collected and serum samples were assayed at an initial dilution of 1:10. Samples that were positive at the 1:10 dilution were serially diluted 1:2 and assayed until a negative result was attained. The titer of the most dilute sample yielding a positive result was recorded as the titer for that time point. Immunogenicity was measured by the number of participants in each study arm with anti-ETI-204 antibody values post-treatment ≥ 4-times higher than baseline at Day 8, 43 or 71, or if the titer was negative at baseline, the post-treatment sample(s) required a titer of at least 1:20 for it to be considered positive.|On Day 1 prior to the start of infusion and on Days 8, 43, and 71.|All participants who received study drug and were included in the safety population.|||Participants|||Count of Participants
2623614|NCT01929226|Secondary|Volume of Distribution at Steady State (Vss)|Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71.|In addition, for several participants, certain PK parameter values were set to missing for the purposes of calculating descriptive statistics in the primary analysis, in accordance with the SAP. The extrapolated portion of AUC(0-inf) exceeded 20% of AUC(0-inf) in 8 participants, therefore, Vss was not reported for these individuals.|||Liters||Standard Deviation|Mean
2623615|NCT01929226|Secondary|Volume of Distribution (Vd)|Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71.|In addition, for several participants, certain PK parameter values were set to missing for the purposes of calculating descriptive statistics in the primary analysis, in accordance with the SAP. The extrapolated portion of AUC(0-inf) exceeded 20% of AUC(0-inf) in 8 participants, therefore, Vd was not reported for these individuals.|||Liters||Standard Deviation|Mean
2623616|NCT01929226|Secondary|Systemic Clearance (CL)|Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71.|In addition, for several participants, certain PK parameter values were set to missing for the purposes of calculating descriptive statistics in the primary analysis, in accordance with the SAP. The extrapolated portion of AUC(0-inf) exceeded 20% of AUC(0-inf) in 8 participants, therefore, CL was not reported for these individuals.|||Liters/day||Standard Deviation|Mean
2623891|NCT01928186|Secondary|Post-treatment Standardized Uptake Values (SUV) by FLT PET|FLT SUV in breast tumor tissue as determined by the post-treatment FLT PET|1 to 6 weeks post-therapy start||||g/mL||Full Range|Median
2623618|NCT01929226|Secondary|Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf)|Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71.|In addition, for several participants, certain PK parameter values were set to missing for the purposes of calculating descriptive statistics in the primary analysis, in accordance with the SAP. The extrapolated portion of AUC(0-inf) exceeded 20% of AUC(0-inf) in 8 participants, therefore, AUC(0-inf) was not reported for these individuals.|||µg.day/mL||Standard Deviation|Mean
2623619|NCT01929226|Secondary|Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last)|Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71.|Of the 210 participants who received ETI-204, 202 were included in the PK population. Reasons for exclusion were: missing dosing record (1), discontinued study drug due to an AE (6) and mechanical issues with the infusion pump (1). 3 additional participants were excluded from the AUC0-last calculation because of missing PK collection time points.|||µg.day/mL||Standard Deviation|Mean
2623620|NCT01929226|Secondary|Time to Maximum Observed Plasma Concentration of ETI-204 (Tmax)|Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71.|Of the 210 participants who received ETI-204, 202 were included in the PK population. One was excluded due to missing dosing record and 7 received partial doses of ETI-204 (6 discontinued study drug due to an AE and one received a partial dose because of mechanical issues with the infusion pump).|||days||Full Range|Median
2623621|NCT01929226|Secondary|Maximum Observed Plasma Concentration of ETI-204 (Cmax)|Blood samples were obtained and serum concentrations were determined using a validated enzyme-linked immunosorbent assay method with an assay range of 100 ng/mL to 5000 ng/mL.|On Day 1, prior to the start of infusion, at the end of infusion, and 3 and 8 hours after the start of infusion and on Days 2, 8, 15, 29, 43, and 71.|Of the 210 participants who received ETI-204, 202 were included in the PK population. One was excluded due to missing dosing record and 7 received partial doses of ETI-204 (6 discontinued study drug due to an AE and one received a partial dose because of mechanical issues with the infusion pump).|||µg/mL||Standard Deviation|Mean
2623622|NCT01929226|Primary|Number of Participants Who Experienced Adverse Events|Safety was assessed for all subjects in the safety population by collecting and monitoring vital signs, clinical laboratory tests, ECGs, physical examinations, skin assessments, infusion site assessments, and adverse events.|Up to 71 days or 101 days (30 days after the final study visit) for subjects with ongoing adverse events at the final study visit, for each group.|All randomized participants who received study drug.|||Participants|||Count of Participants
2623623|NCT01929135|Secondary|Change in Gingival Index|"Determined as score assigned to each site evaluated respect to clinical criteria as followed:~Score Criteria:~0. No inflammation~Mild inflammation, slight change in color, slight edema, no bleeding on probing.~Moderate inflammation, moderate glazing, redness, bleeding on probing.~Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.~Then was calculated a score for each sextant summed the score and divided by the number of examined sites. Later was summed each sextant score and divided by sextant evaluated.~The change was calculated as baseline measure minus 1 month later measure."|baseline and 1 month after intervention||||score on a scale||Standard Deviation|Mean
2623624|NCT01929135|Secondary|Change in Bleeding on Probing Index (BOP)|"The bleeding on probing index (BOP) will be determined by assigning + to the presence of bleeding on vestibular / palatine probing of the tooth examined and with a sign - the abscence. Later the + signs will be summed and divided by the number of sites examined.~Change in BOP: baseline measure minus 1 month later measure."|baseline and 1 month after intervention||||percentage of BOP||Standard Deviation|Mean
2623625|NCT01929135|Secondary|Change in Clinical Attachment Level (CAL)|"The Clinical Attachment Level (CAL) is defined as the distance from the cement-enamel junction to the fornix of the pocket. For each tooth will be performed periodontal probing at 6 sites (mesiobuccal, mediobuccal, distobuccal mesiolingual / palatal mediolingual / distolingual palatal / lingual).~Change in CAL: baseline measure minus 1 month later measure."|baseline and 1 month after intervention||||millimeters||Standard Deviation|Mean
2623626|NCT01929135|Secondary|Change in Mean Pocket Depth (PD)|"The PD will be defined as the distance from the free gingival margin to the bottom of the pocket. For each tooth will be conducted periodontal probing at 6 sites (mesiobuccal, mediobuccal, distobuccal, mesiolingual / palatal, mediolingual / palatal, distolingual/ palatal).~Change in mean PD: baseline measure minus 1 month later measure."|baseline and 1 month later||||millimeters||Standard Deviation|Mean
2623627|NCT01929135|Primary|Change in Periodontal Inflammation Surface Area (PISA)|"PISA will be computed through an Excel spreadsheet, using data of clinical attachment level, gingival recession and bleeding on probing.~Change in PISA: baseline measure minus 1 month later measure."|baseline and 1 month later of intervention||||square millimeters||Standard Deviation|Mean
2623628|NCT01929109|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) (0-∞) of LY2409021 In Participants With ESRD Before and After Dialysis||Period 1 (Dialysis) and Period 2 (Non Dialysis)- Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose|All participants in Group 5 who received at least 1 dose of study drug and had evaluable AUC data.|||ng•h/mL||Geometric Coefficient of Variation|Geometric Mean
2623629|NCT01929109|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2409021 in Participants With End Stage Renal Disease (ESRD) Before and After Dialysis||Period 1 (Dialysis) and Period 2 (Non Dialysis) Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose|All participants in Group 5 who received at least 1 dose of study drug and had evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2623892|NCT01928186|Secondary|Post-treatment FLT Transport (K1) Values by FLT PET|K1 (blood flow measure) in breast tumor tissue as determined by the post-therapy FLT PET|1 to 6 weeks post-therapy start||||mL/min/mL||Full Range|Median
2623631|NCT01929109|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2409021||Predose, 0.5, 1, 2, 4, 6, 7, 8, 9, 10, 12, 24, 48, 72, 96, 144, 192, 264, 336 hours postdose|All participants in Groups 1-4 who received at least 1 dose of study drug and had evaluable PK data, excluding one participant (discontinued for a protocol violation). No efficacy or safety data for this participant are included in results.|||Nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2623632|NCT01929083|Other Pre-specified|Ratio of Serum Progesterone:Estradiol Concentrations During the Progesterone and Placebo Phases||After 7 days of progesterone or placebo||||Ratio||Standard Deviation|Mean
2623633|NCT01929083|Other Pre-specified|Serum Progesterone Concentrations During Progesterone and Placebo Phases||After 7 days of progesterone or placebo||||ng/mL||Standard Deviation|Mean
2623634|NCT01929083|Other Pre-specified|Serum Estradiol Concentrations During the Progesterone and Placebo Phases||Following 7 days of progesterone or placebo||||pg/mL||Standard Deviation|Mean
2623635|NCT01929083|Other Pre-specified|Maximum (Peak) Serum Ibutilide Concentrations During Progesterone and Placebo Phases||Within 1 hour following ibutilide administration (0, 15 & 30 minutes and 1 hours.)||||pg/mL||Standard Deviation|Mean
2623636|NCT01929083|Other Pre-specified|Adverse Effects Associated With Ibutilide in the Progesterone and Placebo Phases||Within 8 hours following ibutilide administration||||percentage of participants|||Number
2623637|NCT01929083|Primary|Area Under the QTcI - Time Curve (AUEC)||From beginning of 10-minute ibutilide infusion to 1 hour following ibutilide infusion||||ms*hr||Standard Deviation|Mean
2623638|NCT01929083|Primary|Maximum % Change From Baseline in QTcI Intervals Following Ibutilide Administration||After 7 days of progesterone or placebo||||percentage change from baseline value||Standard Deviation|Mean
2623639|NCT01929083|Secondary|Incidence of Progesterone-associated Adverse Effects Compared to Placebo||During 7 days of treatment with oral progesterone or placebo||||percentage of participants|||Number
2623640|NCT01929083|Primary|Maximum Individual-corrected QT Interval (QTcI)|QT intervals will be corrected as follows: Prior to randomization, subjects will come to the Indiana Clinical Research Center for a 12-hour stay, during which three ECGs, one minute apart, will be obtained at the following times: 0, 15 & 30 minutes, and 1, 2, 4, 6, 8, and 12 hours. Subjects will be discharged, and then return then next morning for the 24 hour ECG. QT and RR intervals will be used to determine each subject's individual rate-corrected QT interval (QTcI) using the parabolic model QT = β•RRα, where RR is the interval between adjacent QRS complexes, and α and β are subject-specific correction factors.|0, 15 & 30 minutes, and 1, 2, 4, 6, 8, and 12 hours post-ibutilide administration||||ms||Standard Deviation|Mean
2623641|NCT01929083|Primary|Baseline (Pre-Ibutilide) QTcI Intervals||After 7 days of progesterone or placebo, prior to receiving IV ibutilide||||ms||Standard Deviation|Mean
2623642|NCT01929057|Secondary|Level of Antibody to CAMP(Christie-Atkins-Munch-Petersen) Factor|Antibody titers were determined by using recombinant CAMP factor or green fluorescent protein (GFP) as a capture antigen for coating onto a enzyme-linked immunosorbent assay (ELISA) plate. The endpoint was defined as the dilution of serum on CAMP factor-coated wells producing the same Optical Density(570-450) as a 1/100 dilution of serum on GFP-coated wells. Sera negative at the lowest dilution tested were assigned endpoint titers of 100. The data were presented as geometric mean endpoint ELISA titers.|post biopsy||||titers||Standard Error|Geometric Mean
2623643|NCT01929057|Primary|Level of IL-1β|The amount of IL-1β, an inflammatory marker, is measured in skin biopsies obtained from healthy patients and compared with levels in biopsies of acne lesions.|post biopsy||||pg/mg|Biopsies|Standard Deviation|Mean
2623644|NCT01929044|Secondary|Proportion of Patients Who Need the Second Injection|Proportion of patients who need the second injection at 20 minutes after the first injection.|20 minutes after the first injection.|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.|||Percentage of Patients||95% Confidence Interval|Number
2623645|NCT01929044|Secondary|Global Assessment of Efficacy by the Patient at 120 Minutes After the First Injection|"Global assessment of efficacy by the patient. The patient was to assess the efficacy at 120 min after the first injection using a 4-point rating scale by answering the question: How would you rate the effect of the study medication for relieving your acute gastric or intestinal spasm-like pain? (0 = poor; 1 = fair; 2 = good; 3 = very good)."|120 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.|||Percentage of Patients|||Number
2623646|NCT01929044|Secondary|PID From Pre-dose Baseline at 120 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 120 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = 'no pain' to 10 = 'worst pain possible'.|Baseline and 120 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.|||Units on a scale||Standard Error|Least Squares Mean
2623647|NCT01929044|Secondary|PID From Pre-dose Baseline at 60 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 60 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = 'no pain' to 10 = 'worst pain possible'.|Baseline and 60 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.|||Units on a scale||Standard Error|Least Squares Mean
2623648|NCT01929044|Secondary|PID From Pre-dose Baseline at 30 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 30 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = 'no pain' to 10 = 'worst pain possible'.|Baseline and 30 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.|||Units on a scale||Standard Error|Least Squares Mean
2623704|NCT01928927|Secondary|Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|48 weeks|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD8+CD38+HLA-DR+ data."|||Percent of CD8+ expressing CD38+HLA-DR+||Inter-Quartile Range|Median
2623649|NCT01929044|Secondary|PID From Pre-dose Baseline at 10 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 10 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = 'no pain' to 10 = 'worst pain possible'.|Baseline and 10 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS), who revealed no important protocol violations that would impact the analysis of primary endpoint.|||Units on a scale||Standard Error|Least Squares Mean
2623650|NCT01929044|Primary|PID From Pre-dose Baseline at 20 Minutes After First Injection.|Pain intensity difference (PID) from pre-dose baseline at 20 minutes after first injection. It was assessed using an 11-point numerical rating scale (NRS) ranging from 0 = 'no pain' to 10 = 'worst pain possible'.|Baseline and 20 minutes after the first injection|Per-Protocol Set (PPS): All patients in full analysis set (FAS: all patients who provided any data for the primary efficacy endpoint constituted the full analysis set.), who revealed no important protocol violations that would impact the analysis of primary endpoint|||Units on a scale||Standard Error|Least Squares Mean
2623651|NCT01929031|Secondary|Time to Meaningful Pain Relief|Time to meaningful pain relief was captured by a stopwatch, which was started by the study staff immediately after the administration of the first dose of trial medication and which was to be stopped by the patient as soon as he/she felt meaningful pain relief. Time to meaningful pain relief was censored at 8 hours.|8 hours|Patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS)|||hours||95% Confidence Interval|Median
2623652|NCT01929031|Secondary|Duration of Pain Relief|Duration of pain relief was defined as the time between the administration of first dose of trial medication and first dose of rescue medication or second dose of trial medication, whichever was first. Duration of pain relief was censored at 8 hours.|8 hours|Patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS)|||hours||95% Confidence Interval|Median
2623653|NCT01929031|Secondary|Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 2 Hours (SPRID0-2h)|SPRID0-2h: Time-weighted sum of PAR and PID from 0 to 2 hours, score range: -10 (worst) to 28 (best). PI was assessed on a 0-10 numerical pain rating scale (NPRS), where 0=no pain and 10=worst possible pain, pre-dose and at 0.25,0.5,0.75,1,1.5 and 2 hours; PAR was assessed on a 5-point verbal rating scale (VRS) (0=none to 4=complete) at the same post-dose time points. Time-weights were equal to the elapsed time (hour) between the time point of interest and the preceding time point. All PAR and pain intensity (PI) assessments completed after the patient had taken rescue medication or the second dose of study medication, whichever was first, until hour 2 was considered missing. Last observation carried forward (LOCF) was used with the last completed PI/PAR assessments prior to first rescue/second study medication, whichever was first, to impute missing values up to 2 hours.|0 to 2 hours|Patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS)|||units on a scale||Standard Error|Least Squares Mean
2623654|NCT01929031|Primary|Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 8 Hours (SPRID0-8h)|SPRID0-8h: Time-weighted sum of PAR and PID from 0 to 8 hours, score range: -40 (worst) to 112 (best). PI was assessed on a 0-10 numerical pain rating scale (NPRS), where 0=no pain and 10=worst possible pain, pre-dose and at 0.25,0.5,0.75,1,1.5,2,3,4,5, 6,7 and 8 hours; PAR was assessed on a 5-point verbal rating scale (VRS) (0=none to 4=complete) at the same post-dose time points. Time-weights were equal to the elapsed time (hour) between the time point of interest and the preceding time point. All PAR and pain intensity (PI) assessments completed after the patient had taken rescue medication or the second dose of study medication, whichever was first, until hour 8 were considered missing. Last observation carried forward (LOCF) was used with the last completed PI/PAR assessments prior to first rescue/second study medication, whichever was first, to impute missing values up to 8 hours.|0 to 8 hours|Randomized patients who used at least one dose of study medication and provided any post-treatment data for the primary efficacy endpoint (FAS)|||units on a scale||Standard Error|Least Squares Mean
2623655|NCT01929018|Secondary|World Health Organization Disability Assessment Scale|Scores ranging from 1 (no difficulty) to 5 (extreme difficulty/cannot do). Overall disability was calculated by summing the scores for the 12 items; higher scores indicated greater disability (score range: 12-60).|Baseline, 12 weeks, and 24 weeks|38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.|||units on a scale||95% Confidence Interval|Mean
2623656|NCT01929018|Secondary|Self-Efficacy in Managing Chronic Disease Questionnaire|Scale range is 1-10. The score for the scale is the mean of the six items, using a ten point scale. Higher number indicates higher self-efficacy.|Baseline, 12 weeks, and 24 weeks|38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.|||units on a scale||95% Confidence Interval|Mean
2623657|NCT01929018|Secondary|Physical Activity Step Counts|Instrumented physical activity measure, average step counts per day|Baseline, 12 weeks, and 24 weeks|38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.|||average steps per day||95% Confidence Interval|Mean
2623658|NCT01929018|Secondary|Patient-Specific Function Scale|Self-report physical function questionnaire. The outcome is the average score for up to five participant-identified activities on a scale from 0-10 (min 0, max 10). Higher score indicates greater ability to perform functional activities.|Baseline, 12 weeks, and 24 weeks|38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.|||units on a scale||Standard Deviation|Mean
2623659|NCT01929018|Secondary|Houghton Scale|Self-report physical function questionnaire. The outcome is the sum of scores from each item (min 0, max 12). A higher score indicates higher self-report of physical function with the prosthesis.|Baseline, 12 weeks, and 24 weeks|38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.|||units on a scale||Standard Deviation|Mean
2623893|NCT01928186|Secondary|Post-therapy Ki (Flux Constant) Values by FLT PET|Ki (flux constant) in breast tumor tissue as determined by the post-therapy FLT PET|1 to 6 weeks post-therapy start||||mL/min/mL||Full Range|Median
2623660|NCT01929018|Secondary|Prosthesis Evaluation Questionnaire - Mobility Section|Self-report physical function questionnaire measures capacity to perform a list of specific functional tasks (e.g., walking upstairs, getting in and out of a vehicle. Scores range from being unable or hardly able (0) to having no problems (4). An average score across the 12-item questionnaire was used in the analysis. Lower numbers indicate less difficulty.|Baseline, 12 weeks, and 24 weeks|38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.|||units on a scale||95% Confidence Interval|Mean
2623661|NCT01929018|Secondary|Five Meter Walk Test|"Performance-based physical function test measures the time to walk 5 meters at the participant's normal, everyday pace."|Baseline, 12 weeks, and 24 weeks|38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.|||meters/second||95% Confidence Interval|Mean
2623662|NCT01929018|Secondary|Two-Minute Walk Test|Performance-based physical function test measures total number of meters walked in two minutes on a level walkway.|Baseline, 12 weeks, and 24 weeks|38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.|||meters||95% Confidence Interval|Mean
2623663|NCT01929018|Primary|Timed Up-and-Go Test|Performance-based physical function test able to predict falls for people with lower limb amputation. The TUG test time is taken from rising from a chair, walking 3 meters, turning, walking back and sitting down. Continuous scale; higher time indicates lower physical function, higher likelihood of falls.|Baseline, 12-weeks, and 24 weeks|38 (35 men, 3 women; 19 INT, 19 CTL) enrolled. 1 INT and 1 CTL lost to follow-up. 36 participants assessed at all time points. Two CTL at 12 weeks and 2 CTL,1 INT at 24 weeks completed questionnaires only.|||seconds||95% Confidence Interval|Mean
2623664|NCT01928940|Secondary|Phase II: Number of Participants With Worst-case On-therapy Change From Baseline in Left Ventricular Ejection Fraction as Assessed by Echocardiogram|Absolute change from Baseline in LVEF were summarized at each scheduled assessment time and in the worst-case post Baseline. Only the post Baseline assessments that used the same method (ECHO or MUGA) as the Baseline assessments were used to derive the change from Baseline. The change from Baseline was categorized as: any increase; no change; 0-<10 Decrease, 10-19 Decrease, >=20 Decrease, >=10 Decrease and >= LLN, >=10 Decrease and below LLN, >=20 Decrease and >=LLN and >=20 Decrease and below LLN. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
2623665|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Electrocardiogram Findings at the Indicated Time Points|Single 12-lead ECGs were performed at Baseline, Weeks 3 to 132 and post-treatment Visit. ECG findings were categorized as: normal, abnormal - CS, or abnormal - NCS, as determined by the investigator.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Participants|||Number
2623666|NCT01928940|Secondary|Phase II: Change From Baseline in Weight at the Indicated Time Points|Mean change in body weight from baseline was determined. Change from Baseline was calculated as the individual post-Baseline value (Weeks 3 to 132 and post-treatment Visit) minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Kg||Standard Deviation|Mean
2623667|NCT01928940|Secondary|Phase II: Change From Baseline in Oxygen Saturation Measured Via Pulse Oxymetry at the Indicated Time Points|Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen, that is called as blood oxygen saturation, or SpO2. Change from Baseline was calculated as the individual post-Baseline value (Days 8 and 15; Weeks 3 to 132 and post-treatment Visit) minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Percentage of oxygen in blood||Standard Deviation|Mean
2623668|NCT01928940|Secondary|Phase II: Number of Participants With Worst-case On-therapy Change From Baseline in Temperature|Change from Baseline in temperature is categorized as a decrease to <=35 degrees C, change to normal or no change as 35-38 degrees C, and increase to >=38 degrees C relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant temperature value decreased to <=35 degrees C and increased to >=38 degrees C post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
2623669|NCT01928940|Secondary|Phase II: Number of Participants With Worst-case On-therapy Change From Baseline in Heart Rate|Change from Baseline in heart rate is categorized as decrease to <60 bpm, change to normal or no change, and increase to >100 bpm relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant's heart rate value decreased to <60 bpm and increased to >100 bpm post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
2623684|NCT01928940|Secondary|Phase I: Plasma Trough Concentration (Ctau) of GSK2118436 and Metabolites, and GSK1120212 After a Single and Repeat Dose|Trough concentration is the lowest level that a drug is present in the body. Pre-dose (trough) blood samples were collected on Day 8, Day 15, Weeks 3, 8, 16 and 24 for estimating plasma trough concentration. GSK2118436 metabolites included GSK2285403, GSK2298683, and GSK2167542. Ctau was determined from the raw concentration-time data.|At pre-dose on Day 8, Day 15, Weeks 3, 8, 16 and 24|PK Population.Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2623670|NCT01928940|Secondary|Phase II: Number of Participants With Worst-case On-therapy Increase From Baseline in Systolic and Diastolic Blood Pressure to Grade 2 or Grade 3|SBP and DBP values were graded using (NCI CTCAE version 4.0). SBP was categorized as: G1 (Increase to >=120 to 140 mmHg), G2 (Increase to >=140 to <160 mmHg), and G3 (Increase to >=160 mmHg). DBP was categorized as: G1 (Increase to >=80 to <90 mmHg), G2 (Increase to >=90 to <100 mmHg), and G3 (Increase to >=100 mmHg). The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values were assumed to have a Baseline value of G0.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
2623671|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in ECOG Perormance Status|The ECOG pef status 5-point scale is used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the par. and to determine appropriate treatment and prognosis: G0, fully active, able to carry on all pre-disease pef without restriction. G1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, example, light house work, office work. G2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about >50% of waking hrs. G3, capable of only limited selfcare; confined to bed or chair >50% of waking hrs. G4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. G5, dead. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. Number of par. who improved, had no change, or deteriorated in pef status from BL is summarized.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
2623672|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Urinalysis Results|Urine samples were collected for urine dipstick analysis at Baseline and at the post-treatment Visit. The number of participants with negative (absence) and positive (presence: trace, 1+, 2+, 3+, 4+ or 5+) results for UOB, UGLU, UKET, UP and UUBIL were summarized. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
2623673|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Hematology Parameters|Hematology parameters were summarized according to NCI CTCAE G, version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters for which an increase to G3 or G4 from Baseline G occurred. For hematology parameters that were not graded according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those parameters for which the category decreased to Low or increased to High relative to the Baseline category. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. Hematology parameters included: hemoglobin, lymphocytes, total neutrophils, platelet count, WBC counts, basophils, eosinophils, hematocrit, MCHC, MCH, MCV, monocytes and RBC count.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
2623674|NCT01928940|Secondary|Phase II: Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Clinical Chemistry Parameters|CCPs were graded according to NCI CTCAE garde version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters for which an increase to G3 or G4 from Baseline grade occurred. CCPs that were not graded according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those parameters for which the category decreased to Low or increased to High relative to the Baseline category. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. CCPs included: albumin, alkaline phosphatase, ALT, AST, total bilirubin, calcium, creatinine, glucose, potassium, magnesium, sodium, inorganic phosphorus, chloride, LDH, total protein, urea/BUN and uric acid.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
2623675|NCT01928940|Secondary|Phase II: Number of Participants With Any Adverse Event and Any Serious Adverse Event|An AE is defined as any untoward MO in a part. temporally associated with the use of a MP, whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. SAE is defined as any untoward MO that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect and protocol-specific SAEs:ALT>=3xULN and bilirubin>=2xULN(>35% direct) (or ALT>=3xULN, international normalized ratio>1.5), any new primary cancers, treatment emergent malignancies except basal cell carcinoma, symptomatic or asymptomatic LVEF decrease, retinal pigment epithelial detachment or retinal vein occlusion, pyrexia with hypotension,or dehydration or renal insufficiency,or severe (>=G3) rigor/chills.|From the start of study treatment until 30 days after study treatment discontinuation (average of 1.38 years)|ATS Population|||Participants|||Number
2623676|NCT01928940|Secondary|Phase II: Duration of Response|Duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause among participants with confirmed CR or PR. The participant who showed a CR or PR was included in the analysis of duration of response. Duration of response was assessed by investigator and BICR. Please note the values of the Full Range (min, max) are described irregardless of censoring at data cut-off.|From start of the treatment until disease progression or death (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ATS population.|||Weeks||Full Range|Median
2623693|NCT01928940|Primary|Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Heart Rate|Change from Baseline in heart rate is categorized as decrease to <60 beats per minute (bpm), change to normal or no change, and increase to >100 bpm relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant's heart rate value decreased to <60 bpm and increased to >100 bpm post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population|||Participants|||Number
2623677|NCT01928940|Secondary|Phase II: Progression Free Survival (PFS)|PFS is defined as the time from the first dose of study treatment to the earliest date of disease progression or death due to any cause. The length of this interval is estimated as the date of death or disease progression minus the date of first dose plus one day. The date of documented disease progression is defined as the date of disease progression based on radiologic evidence. Participants with documented date of disease progresssion or death and who had not received subsequent anticancer treatment prior to the date of documented disease progression or death were included in the analysis of PFS. PFS was assessed by investigator and BICR. Please note the values of the Full Range (min, max) are described irregardless of censoring at data cut-off.|From start of the treatment until disease progression or death (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ATS population.|||Weeks||Full Range|Median
2623678|NCT01928940|Secondary|Phase II: Number of Participants With Unconfirmed Overall Response|"ORR is defined as the percentage of participants with an unconfirmed CR or PR according to RECIST version 1.1. RECIST is a set of rules that define when tumors in cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. CR is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions after treatment from Baseline (before study drug administration). Unconfirmed ORR was assessed by investigator and BICR."|Every 8 weeks from start of the treatment until disease progression, death, or withdrawal of consent (average of 1.38 years)|ATS Population|||Participants|||Number
2623679|NCT01928940|Secondary|Phase I: Duration of Response|Duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause among participants with confirmed CR or PR. The participant who showed a CR or PR was included in the analysis of duration of response. Duration of response was assessed by investigator and BICR. Please note the values of the Full Range (min, max) are described irregardless of censoring at data cut-off.|From start of the treatment until disease progression or death (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ATS population.|||Weeks||Full Range|Median
2623680|NCT01928940|Secondary|Phase I: Progression Free Survival (PFS)|PFS is defined as the time from the first dose of study treatment to the earliest date of disease progression or death due to any cause. The length of this interval is estimated as the date of death or disease progression minus the date of first dose plus one day. The date of documented disease progression is defined as the date of disease progression based on radiologic evidence. Participants with documented date of disease progresssion or death and who had not received subsequent anticancer treatment prior to the date of documented disease progression or death were included in the analysis of PFS. PFS was assessed by investigator and BICR. Please note the values of the Full Range (min, max) are described irregardless of censoring at data cut-off.|From start of the treatment until disease progression or death (average of 1.38 years)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ATS population.|||Weeks||Full Range|Median
2623681|NCT01928940|Secondary|Phase I: Number of Participants With Unconfirmed Overall Response Rate|"ORR is defined as the percentage of participants with an unconfirmed CR or PR according to RECIST version 1.1. RECIST is a set of rules that define when tumors in cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. CR is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions after treatment from Baseline (before study drug administration). Unconfirmed ORR was assessed by investigator and BICR."|Every 8 weeks from start of the treatment until disease progression, death, or withdrawal of consent (average of 1.38 years)|ATS Population|||Participants|||Number
2623682|NCT01928940|Secondary|Phase I: Number of Participants With Confirmed Overall Response Rate|"Confirmed ORR is defined as the percentage of participants with a confirmed CR or PR according to RECIST, version 1.1. RECIST is a set of rules that define when tumors in cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions after treatment from Baseline (before study drug administration). ORR was assessed by investigator and BICR."|Every 8 weeks from start of the treatment until disease progression, death, or withdrawal of consent (average of 1.38 years)|ATS Population|||Participants|||Number
2623683|NCT01928940|Secondary|Phase I: Time of Occurrence of Cmax (Tmax) and Terminal Phase Half Life (t1/2) of GSK2118436 and Metabolites, and GSK1120212 After a Single and Repeat Dose|Blood samples were collected from each participant at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr post-dose on Day 21 (repeat dose) for PK analysis. GSK2118436 metabolites included GSK2285403, GSK2298683, and GSK2167542. Tmax is defined as the time of occurrence of Cmax. Tmax was determined directly from the raw concentration-time data. The apparent terminal elimination half-life (t1/2) obtained as the ratio of ln2/lamdaz, where lamdaz is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data. . T1/2 was calculated only at Day 1.|At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr on Day 21 (repeat dose)|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)|||hr||Full Range|Median
2623701|NCT01928927|Secondary|Change in the Proportion of CD4+ T Cells in Lymphoid Tissue From Baseline to Week 48.|Measured as the change from entry to week 48 in %CD3+CD4+ T cells.|48 weeks||2019-01-31|01/2019||||
2623702|NCT01928927|Secondary|Change in Inflammatory Cell Population Type and Number in Adipose Tissue Biopsy Specimens From Baseline to Week 48|Measured as the change from entry to week 48 in the frequency of CD14+, CD16+,CD64+, and/or CD163+ macrophages.|48 weeks||2019-01-31|01/2019||||
2623685|NCT01928940|Secondary|Phase I: Maximum Plasma Concentration (Cmax) of GSK2118436 and Metabolites, and GSK1120212 After a Single and Repeat Dose|Blood samples were collected from each participant at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr post-dose on Day 21 (repeat dose) for PK analysis. GSK2118436 metabolites included GSK2285403, GSK2298683 and GSK2167542. Cmax was determined from the raw concentration-time data.|At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr on Day 21 (repeat dose)|PK Population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2623686|NCT01928940|Secondary|Phase I: Area Under the Plasma Concentration Versus Time Curve (AUC) of GSK2118436 and Metabolites, and GSK1120212 After Single and Repeat Dose|Blood samples were collected from each par. at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr post-dose on Day 21 (repeat dose) for PK analysis. GSK2118436 metabolites included GSK2285403, GSK2298683, and GSK2167542. AUC from time zero to last quantifiable concentration (concn) (AUC[0-t]) was determined using the linear trapezoidal rule for increasing concn and the logarithmic trapezoidal rule for decreasing. The AUC from time zero extrapolated to infinity (AUC[0-inf] was calculated, where data permit, as the sum of AUC(0-t) and Ct/z, where Ct is the observed plasma concn obtained from the log-linear regression analysis of the last quantifiable time-point and z is the terminal phase rate constant. Area under the concentration-time curve over 12 hr and 24 hr dosing interval is called AUC[0-12] and AUC[0-24]. AUC(0-inf) was calculated only at Day 1.|At pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hr after administration of GSK2118436 + GSK1120212 on Day 1 (single dose) and at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hr on Day 21 (repeat dose)|PK Population: all par. included in the ATS population for whom a PK sample was obtained and analyzed. Only those par. available at the specified time points were analyzed (represented by n=X in the category titles).|||hr*nanogram (ng)/mL||Geometric Coefficient of Variation|Geometric Mean
2623687|NCT01928940|Primary|Phase II: Number of Participant With Confirmed Overall Response|"Confirmed overall response (ORR) is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. RECIST is a set of rules that define when tumors in cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions after treatment from Baseline (before study drug administration). ORR was assessed by investigator and blinded independent central review (BICR)."|Every 8 weeks from start of the treatment until disease progression, death, or withdrawal of consent (average of 1.38 years)|ATS Population|||Participants|||Number
2623688|NCT01928940|Primary|Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Assessed by Echocardiogram (ECHO)|Absolute change from Baseline in LVEF were summarized at each scheduled assessment time and in the worst-case post Baseline. Only the post Baseline assessments that used the same method (ECHO or Multi Gated Acquisition Scan [MUGA]) as the Baseline assessments were used to derive the change from Baseline. The change from Baseline was categorized as: any increase; no change; 0-<10 Decrease, 10-19 Decrease, >=20 Decrease, >=10 Decrease and >= lower limit of normal (LLN), >=10 Decrease and below LLN, >=20 Decrease and >=LLN and >=20 Decrease and below LLN. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
2623689|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Electrocardiogram (ECG) Findings at the Indicated Time Points|Single twelve (12)-lead ECGs were perfomred at Baseline, Weeks 3 to 132 and post-treatment Visit. ECG findings were categorized as: normal, abnormal - clinically significant (CS), or abnormal - not clinically significant (NCS), as determined by the investigator.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Participants|||Number
2623690|NCT01928940|Primary|Phase I: Change From Baseline in Weight at the Indicated Time Points|Mean change in body weight from Baseline was determined. Change from Baseline was calculated as the individual post-Baseline value (Weeks 3 to 136 and post-treatment Visit) minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit ( average of 1.38 year)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Kilogram (Kg)||Standard Deviation|Mean
2623691|NCT01928940|Primary|Phase I: Change From Baseline in Oxygen Saturation (SpO2) Measured Via Pulse Oxymetry at the Indicated Time Points|Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen,that is called as blood oxygen saturation or SpO2. Change from Baseline was calculated as the individual post-Baseline value (Days 8,15; Weeks 3 to 136 and post-treatment Visit) minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Percentage of oxygen in blood||Standard Deviation|Mean
2623692|NCT01928940|Primary|Phase I: Number of Participants With Worst-case On-therapy Change From Baseline in Temperature|Change from Baseline in temperature is categorized as a decrease to <=35 degrees celsius (C), change to normal or no change as 35-38 degrees C, and increase to >=38 degrees C relative to the Baseline value. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant temperature value decreased to <=35 degrees C and increased to >=38 degrees C post-Baseline. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|From Baseline until the post-treatment Visit (average of 1.38 years)|ATS Population|||Participants|||Number
2623894|NCT01928186|Secondary|Baseline Standardized Uptake Values (SUV) by FLT PET|FLT SUV in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET|Baseline||||g/mL||Full Range|Median
2623694|NCT01928940|Primary|Phase I: Number of Participants With Worst-case On-therapy Increase From Baseline in Systolic and Diastolic Blood Pressure to Grade 2 or Grade 3|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) values were graded using (NCI CTCAE version 4.0). SBP was categorized as: G1 (Increase to >=120 to 140 millimeters of mercury [mmHg]), G2 (Increase to >=140 to <160 mmHg), and G3 (Increase to >=160 mmHg). DBP was categorized as: G1 (Increase to >=80 to <90 mmHg), G2 (Increase to >=90 to <100 mmHg), and G3 (Increase to >=100 mmHg). The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values were assumed to have a Baseline value of G0.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population|||Participants|||Number
2623695|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance (Pef) Status|The ECOG pef status 5-point scale is used to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the par. and to determine appropriate treatment and prognosis: G0, fully active, able to carry on all pre-disease pef without restriction. G1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, example, light house work, office work. G2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about >50 percent (%) of waking hrs. G3, capable of only limited selfcare; confined to bed or chair >50% of waking hrs. G4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. G5, dead. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. Number of par. who improved, had no change, or deteriorated in pef status from BL is summarized.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population|||Participants|||Number
2623696|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Urinalysis Parameters|Urine samples were collected for urine dipstick analysis at Baseline and at the post-treatment Visit. The number of participants with negative (absence) and positive (presence: trace, 1+, 2+, 3+, 4+ or 5+) results for urine occult blood (UOB), urine glucose (UGLU), urine ketones (UKET), urine protein (UP) and urine urobilinogen (UUBIL) were summarized. The Baseline value is defined as the last pre-treatment value observed.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population|||Participants|||Number
2623697|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Hematology Parameters|Hematology parameters were summarized according to NCI CTCAE G, version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters for which an increase to G3 or G4 from Baseline G occurred. For hematology parameters that were not graded according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those parameters for which the category decreased to Low or increased to High relative to the Baseline category. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. Hematology parameters included: hemoglobin, lymphocytes, total neutrophils, platelet count, white blood cell (WBC) counts, basophils, eosinophils, hematocrit, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes and red blood cell (RBC) count.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population|||Participants|||Number
2623698|NCT01928940|Primary|Phase I: Number of Participants With the Indicated Worst-case Change From Baseline (BL) in the Indicated Clinical Chemistry Parameters (CCPs)|CCPs were graded according to NCI CTCAE grade version 4.0 as: G1, Mild; G2, Moderate; G3, Severe; G4, Life-threatening or disabling; G5, Death. Data are presented for only those parameters (para) for which an increase to G3 or G4 from BL G occurred. CCPs that were not G according to NCI CTCAE criteria, were categorized as High and Low with respect to the normal range. Data are presented only for those para for which the category decreased to Low or increased to High relative to the BL category. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments. CCPs included: albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, calcium, creatinine, glucose, potassium, magnesium, sodium, inorganic phosphorus, chloride, lactate dehydrogenase (LDH), total protein, urea/blood urea nitrogen (BUN) and uric acid.|From Baseline until the post-treatment Visit (average of 1.38 year)|ATS Population|||Participants|||Number
2623699|NCT01928940|Primary|Phase I: Number of Participants With a Dose-limiting Toxicity (DLT)|A DLT was defined as an event occurred during the first 21 days after the first dose of study drugs and met any of the following criteria, according to National Cancer Institutes (NCI) common terminology criteria for AE (CTCAE) grade (G) version 4.0: G4 hematological toxicity; G3 or G4 non-hematologic toxicity (including rash, nausea, vomiting and diarrhea only if uncontrolled with supportive therapy); rash >=G3 that required dose reduction despite supportive care; a G2 or greater non-hematological toxicity that in the judgment of the investigator and medical monitor; dose interruption of greater than 14 consecutive days due to unresolved toxicity; any new G2 or greater valvular heart disease and significant alteration in cardiac valve morphology from Baseline.|From the start of study treatment until 21 days|DLT assessment Population: all participants for whom DLT assessment was appropriately conducted|||Participants|||Number
2623700|NCT01928940|Primary|Phase I: Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence (MO) in a part. temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. SAE is defined as any untoward MO that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect and protocol-specific SAEs:ALT>=3xupper limit of normal(ULN) and bilirubin>=2xULN(>35% direct) (or ALT>=3xULN, international normalized ratio>1.5), any new primary cancers, treatment emergent malignancies except basal cell carcinoma, symptomatic or asymptomatic LVEF decrease, retinal pigment epithelial detachment or retinal vein occlusion, pyrexia with hypotension,or dehydration or renal insufficiency,or severe (>=G3) rigor/chills.|From the start of study treatment until 30 days after study treatment discontinuation (average of 1.38 year)|All Treated Subject (ATS) Population: all participants who received at least one dose of study medication.|||Participants|||Number
2623705|NCT01928927|Secondary|Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|48 weeks|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD4+CD38+HLA-DR+ data."|||Percent of CD4+ expressing CD38+HLA-DR+||Inter-Quartile Range|Median
2623706|NCT01928927|Secondary|Change in Expression of CD38+HLA-DR+ on CD8+ From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|24 weeks|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD8+CD38+HLA-DR+ data."|||Percent of CD8+ expressing CD38+HLA-DR+||Inter-Quartile Range|Median
2623707|NCT01928927|Secondary|Change in Expression of CD38+HLA-DR+ on CD4+ From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|24 weeks|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD4+CD38+HLA-DR+ data."|||Percent of CD4+ expressing CD38+HLA-DR+||Inter-Quartile Range|Median
2623708|NCT01928927|Secondary|Change in Waist-to-hip Ratio From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing waist-to-hip ratio."|||waist cm : hip cm||Inter-Quartile Range|Median
2623709|NCT01928927|Secondary|Change in Waist-to-hip Ratio From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing waist-to-hip ratio."|||waist cm : hip cm||Inter-Quartile Range|Median
2623710|NCT01928927|Secondary|Change in Waist Circumference From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing waist circumference."|||cm||Inter-Quartile Range|Median
2623711|NCT01928927|Secondary|Change in Waist Circumference From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing waist circumference."|||cm||Inter-Quartile Range|Median
2623712|NCT01928927|Secondary|Presence of Metabolic Syndrome at Week 48.|"Components of the metabolic syndrome were defined according to the 2004 updated National Cholesterol Education Program Adult Treatment Panel III [NCEP ATP III] criteria) as the presence of any 3 of the following: Waist: >40 (101.6 cm) in men, >35 (88.9 cm) in women with the exception of Asian-Americans: >35 (88.9 cm) in men, 31 (78.7 cm) in women; Fasting HDL-C <40 mg/dL in men, <50 mg/dL in women; Fasting TG ≥150 mg/dL; Diastolic blood pressure ≥85 mmHg or systolic blood pressure ≥130 mmHg; Fasting plasma glucose ≥100 mg/dL."|Week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing metabolic syndrome components."|||Participants|||Count of Participants
2623713|NCT01928927|Secondary|Prevalence of Metabolic Syndrome at Week 24.|"Components of the metabolic syndrome will be defined according to the 2004 updated National Cholesterol Education Program Adult Treatment Panel III [NCEP ATP III] criteria) as the presence of any 3 of the following: Waist: >40 (101.6 cm) in men, >35 (88.9 cm) in women with the exception of Asian-Americans: >35 (88.9 cm) in men, 31 (78.7 cm) in women; Fasting HDL-C <40 mg/dL in men, <50 mg/dL in women; Fasting TG ≥150 mg/dL; Diastolic blood pressure ≥85 mmHg or systolic blood pressure ≥130 mmHg; Fasting plasma glucose ≥100 mg/dL.~NOTE: This definition of metabolic syndrome may be subject to change in accordance with current guidelines at the time of the final analysis. It will be defined in the Final Statistical Analysis Plan prior to data review for final analysis."|Week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing metabolic syndrome components."|||Participants|||Count of Participants
2623714|NCT01928927|Secondary|Change in HOMA-IR From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing HOMA-IR."|||(mg/dl)x(uIU/ml)/405||Inter-Quartile Range|Median
2623715|NCT01928927|Secondary|Change in Fasting Triglycerides From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing fasting triglycerides."|||mg/dl||Inter-Quartile Range|Median
2623716|NCT01928927|Secondary|Change in Fasting Total Cholesterol From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing fasting total cholesterol."|||mg/dl||Inter-Quartile Range|Median
2623732|NCT01928927|Secondary|Change in TGF-β2 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing TGF-β2."|||pg/ml||Inter-Quartile Range|Median
2623717|NCT01928927|Secondary|Change in Fasting LDL Cholesterol From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing fasting LDL cholesterol."|||mg/dl||Inter-Quartile Range|Median
2623718|NCT01928927|Secondary|Change in Fasting Insulin From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing fasting insulin."|||uIU/ml||Inter-Quartile Range|Median
2623719|NCT01928927|Secondary|Change in Fasting HDL Cholesterol From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing fasting HDL cholesterol."|||mg/dl||Inter-Quartile Range|Median
2623720|NCT01928927|Secondary|Change in Fasting Glucose From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing fasting glucose."|||mg/dl||Inter-Quartile Range|Median
2623721|NCT01928927|Secondary|Change in Circulating CD8+ T Cell Count From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD8+ count."|||cells/mm^3||Inter-Quartile Range|Median
2623722|NCT01928927|Secondary|Change in Circulating CD8+ T Cell Count From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD8+ count."|||cells/mm^3||Inter-Quartile Range|Median
2623723|NCT01928927|Secondary|Change in Circulating CD8+ T Cell Count From Baseline to Week 12|Absolute change was calculated as the value at week 12 minus the value at baseline.|baseline and week 12|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD8+ count."|||cells/mm^3||Inter-Quartile Range|Median
2623724|NCT01928927|Secondary|Change in Circulating CD4+ T Cell Count From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD4+ count."|||cells/mm^3||Inter-Quartile Range|Median
2623725|NCT01928927|Secondary|Change in Circulating CD4+ T Cell Count From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD4+ count."|||cells/mm^3||Inter-Quartile Range|Median
2623726|NCT01928927|Secondary|Change in Circulating CD4+ T Cell Count From Baseline to Week 12|Absolute change was calculated as the value at week 12 minus the value at baseline.|baseline and week 12|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CD4+ count."|||cells/mm^3||Inter-Quartile Range|Median
2623727|NCT01928927|Secondary|Change in TGF-β3 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing TGF-β3."|||pg/ml||Inter-Quartile Range|Median
2623728|NCT01928927|Secondary|Change in TGF-β3 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing TGF-β3."|||pg/ml||Inter-Quartile Range|Median
2623729|NCT01928927|Secondary|Change in TGF-β3 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing TGF-β3."|||pg/ml||Inter-Quartile Range|Median
2623730|NCT01928927|Secondary|Change in TGF-β2 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing TGF-β2."|||pg/ml||Inter-Quartile Range|Median
2623731|NCT01928927|Secondary|Change in TGF-β2 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing TGF-β2."|||pg/ml||Inter-Quartile Range|Median
2623822|NCT01928693|Secondary|Healing Rate|Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days.|29 days||||Days|||Number
2623733|NCT01928927|Secondary|Change in TGF-β1 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing TGF-β1."|||pg/ml||Inter-Quartile Range|Median
2623734|NCT01928927|Secondary|Change in TGF-β1 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing TGF-β1."|||pg/ml||Inter-Quartile Range|Median
2623735|NCT01928927|Secondary|Change in TGF-β1 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing TGF-β1."|||pg/ml||Inter-Quartile Range|Median
2623736|NCT01928927|Secondary|Change in sCD163 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing sCD163."|||ng/ml||Inter-Quartile Range|Median
2623737|NCT01928927|Secondary|Change in sCD163 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing sCD163."|||ng/ml||Inter-Quartile Range|Median
2623738|NCT01928927|Secondary|Change in sCD163 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing sCD163."|||ng/ml||Inter-Quartile Range|Median
2623739|NCT01928927|Secondary|Change in sCD14 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing sCD14."|||mcg/ml||Inter-Quartile Range|Median
2623740|NCT01928927|Secondary|Change in sCD14 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing sCD14."|||mcg/ml||Inter-Quartile Range|Median
2623741|NCT01928927|Secondary|Change in sCD14 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing sCD14."|||mcg/ml||Inter-Quartile Range|Median
2623742|NCT01928927|Secondary|Change in Hyaluronic Acid From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing hyaluronic acid."|||ng/ml||Inter-Quartile Range|Median
2623743|NCT01928927|Secondary|Change in Hyaluronic Acid From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing hyaluronic acid."|||ng/ml||Inter-Quartile Range|Median
2623744|NCT01928927|Secondary|Change in Hyaluronic Acid From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing hyaluronic acid."|||ng/ml||Inter-Quartile Range|Median
2623745|NCT01928927|Secondary|Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CICP."|||ng/ml||Inter-Quartile Range|Median
2623746|NCT01928927|Secondary|Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CICP."|||ng/ml||Inter-Quartile Range|Median
2623747|NCT01928927|Secondary|Change in Collagen I C-terminal Pro-peptide (CICP) From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing CICP."|||ng/ml||Inter-Quartile Range|Median
2623823|NCT01928693|Primary|Complete Healing|The primary outcome will be complete healing of the corneal ulcer, defined as complete reepithelialization by Day 29.|29 days||||participant|||Number
2623824|NCT01928680|Secondary|Number and Severity of Adverse Events of Patients Enrolled in This Trial|Number and severity of adverse events sufferred by patients who received capecitabine and cisplatin regimen.|1 year|||||||
2623748|NCT01928927|Secondary|Change in Adiponectin From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing adiponectin."|||ng/ml||Inter-Quartile Range|Median
2623749|NCT01928927|Secondary|Change in Adiponectin From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing adiponectin."|||ng/ml||Inter-Quartile Range|Median
2623750|NCT01928927|Secondary|Change in Adiponectin From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing adiponectin."|||ng/ml||Inter-Quartile Range|Median
2623751|NCT01928927|Secondary|Change in IL-7 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing IL-7."|||pg/ml||Inter-Quartile Range|Median
2623752|NCT01928927|Secondary|Change in IL-7 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing IL-7."|||pg/ml||Inter-Quartile Range|Median
2623753|NCT01928927|Secondary|Change in IL-7 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing IL-7."|||pg/ml||Inter-Quartile Range|Median
2623754|NCT01928927|Secondary|Change in IL-6 From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing IL-6."|||pg/ml||Inter-Quartile Range|Median
2623755|NCT01928927|Secondary|Change in IL-6 From Baseline to Week 24|Absolute change was calculated as the value at week 24 minus the value at baseline.|baseline and week 24|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing IL-6."|||pg/ml||Inter-Quartile Range|Median
2623756|NCT01928927|Secondary|Change in IL-6 From Baseline to Week 4|Absolute change was calculated as the value at week 4 minus the value at baseline.|baseline and week 4|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing IL-6."|||pg/ml||Inter-Quartile Range|Median
2623757|NCT01928927|Secondary|Highest Grade Non-biopsy-related Adverse Event|"Safety was summarized as the highest grade non-biopsy-related sign/symptom, laboratory event, or diagnosis per participant.~Grading (Grade 0: normal, Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening) was done by site clinicians using DAIDS AE Grading table.~NOTE: As adipose tissue and lymph node biopsies are generally considered to be minimal risk procedures, biopsy safety profile were not formally be evaluated as an endpoint in this protocol."|after baseline to week 48|All Step 2 participants|||Participants|||Count of Participants
2623758|NCT01928927|Secondary|Change in Percent Collagen VI Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing adipose collagen VI deposition."|||percent area stain positive||Inter-Quartile Range|Median
2623759|NCT01928927|Secondary|Change in Percent Fibronectin Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing adipose tissue fibronectin deposition."|||percent area stain positive||Inter-Quartile Range|Median
2623760|NCT01928927|Secondary|Change in Percent Fibronectin Deposition on Lymph Node Pathology From Baseline to Week 48|Absolute change was calculated as the value at week 48 minus the value at baseline.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing lymphoid tissue fibronectin deposition."|||percent area stain positive||Inter-Quartile Range|Median
2623761|NCT01928927|Primary|Change in Percent Collagen I Deposition on Subcutaneous Abdominal Adipose Tissue Pathology From Baseline to Week 48|Percent collagen I deposition defined as percentage of fibrotic/collagen area to total area. Change was absolute change defined as the Week 48 value minus the baseline value.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing subcutaneous abdominal adipose tissue collagen I deposition."|||percent area stain positive||Inter-Quartile Range|Median
2623825|NCT01928680|Secondary|Overall Survival||3 years|||||||
2623826|NCT01928680|Secondary|Progression Free Survival||2 years|||||||
2623827|NCT01928680|Primary|Overall Response Rate||6 months||||percentage of response|||Number
2623762|NCT01928927|Primary|Change in Percent Collagen I Deposition on Lymph Node Pathology From Baseline to Week 48|Percent collagen I deposition is defined as the average % collagen stained in multiple uniform sized high magnification images in each sample. Change was absolute change defined as the Week 48 value minus the baseline value.|baseline and week 48|"Per-protocol population: Participants who 1) completed the protocol, 2) completed treatment (if on telmisartan arm), 3) did not have confirmed virologic failure, 4) had paired biopsies at baseline and week 48.~Additionally, have non-missing lymphoid tissue collagen I deposition."|||percent area stain positive||Inter-Quartile Range|Median
2623763|NCT01928862|Secondary|"Number of Participants in Each Category of the Subject's Tolerability and Satisfaction Questionaire"|"Subject's Tolerability and Satisfaction Questionnaire consists of three questions. Question (Q)1 was How easy was it to drink the bowel cleanout medicine? and Q2 was How did the bowel cleanout medicine taste?. Q3 had five subparts namely: 1. How often did your tummy hurt since you started the medicine? and 2. How often did you feel fullness in your tummy, since you started the cleanout? and 3. How often did you wake up last night and 4. How often did you feel sick to your stomach (nausea) since you started the cleanout?' and 5. How much were you bothered by going to the washroom since you started the cleanout?~Satisfactory was defined as a response of 1 (Very Easy) or 2 (Easy) on Q1 and a response of 1 (Very Well) or 2 (Well) on Q2.~Tolerable was defined as a response of 1 (Never) or 2 (Rarely) to the five subparts specified in Q3."|1 day of colonoscopy|The secondary efficacy analysis was based on the ITT analysis set, which included all participants who were randomized.|||participants|||Number
2623764|NCT01928862|Secondary|Number of Participants Who Took the Assigned Dose for Colon Cleansing|The proportion of participants who took the assigned dose of Prepopik® was assessed.|Approx. 1 day (From the day before colonoscopy to the day of colonoscopy)|The safety analysis set included participants who received at least one dose of the trial medication. Participants were analyzed according to actual treatment received. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).|||participants|||Number
2623765|NCT01928862|Secondary|Number of Participants With Abnormal Findings in Physical Examination|Complete physical examination was conducted at screening and directed physical examinations at other time-points. Directed physical examinations are presented.|From up to 42 days prior to colonoscopy, on the day of randomization, and at the day of colonoscopy|The safety analysis set included participants who received at least one dose of the trial medication. Participants were analyzed according to actual treatment received. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).|||participants|||Number
2623766|NCT01928862|Secondary|Number of Participants With Abnormal Findings in Laboratory Tests|Proportion of participants with abnormal findings in laboratory tests are presented.|From up to 42 days prior to colonoscopy, at the day of colonoscopy, and up to 7 days post colonoscopy|The safety analysis set included participants who received at least one dose of the trial medication. Participants were analyzed according to actual treatment received. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).|||participants|||Number
2623767|NCT01928862|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a participant taking part in a clinical trial. Proportion of participants with AE are presented.|Up to 33 days after colonoscopy|The safety analysis set included participants who received at least one dose of the trial medication. Participants were analyzed according to actual treatment received. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).|||participants|||Number
2623768|NCT01928862|Primary|"Percentage of Participants Defined by Excellent or Good in the Aronchick Scale"|"Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed). The participant is considered to be a responder if overall colon cleansing is excellent or good on this 4-point scale."|On the day of colonoscopy|The primary efficacy analysis was based on the intention-to-treat (ITT) analysis set, which included all participants who were randomized.|||percentage of participants||90% Confidence Interval|Number
2623769|NCT01928849|Other Pre-specified|Observation of Epigenetic Alterations That Occur in the Transition From Acute to Chronic Pain.|Epigenetic analysis (DNA methylation) will be correlated with pain sub-type and use of Valproic Acid.|Changes between enrollment, end of study drug and 3 months or time of final adjudication|||||||
2623770|NCT01928849|Secondary|Richmond Agitation-Sedation Scale (RASS)|The RASS is a commonly used, valid and reliable assessment tool for use in hospitalized patients. Validity testing reveals good inter-rater reliability among medical, surgical, and intensive care units. We will analyze the numeric score at each assessment (range -5 (unarousable) to 4 (combative)).|during hospitalization (0-24 hours and 24-48 hours post-surgery)|Participants who completed the RASS assessment on post-op day 1.|||score on a scale||Inter-Quartile Range|Median
2623771|NCT01928849|Secondary|Defense and Veterans Pain Rating Scale (DVPRS) Score|The DVPRS is a pain assessment tool developed by the military in an effort to improve reliability and interpretability of pain assessment in the military population. It has been found to be an effective and valid tool in this population. We will analyze the change in numeric pain response (range 0-10) and the sum of the four supplemental questions (range 0-40) from baseline. Higher scores indicate greater pain and functional limitations.|Assessments at enrollment and 3 months or time of final adjudication assessment (up to 6 months)|Patients who completed questionnaires at both time points|||score on a scale||Inter-Quartile Range|Median
2623772|NCT01928849|Secondary|Change in Self-Reported Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (S-LANSS)|The S-LANSS is a self-reported version of the Leeds Assessment of Neuropathic Symptoms and Signs pain scale. It aims to differentiate neuropathic pain from somatic or nociceptive pain. We will analyze the change in numeric average pain score during the past week (range from 0-10) from baseline. Higher scores indicate greater pain.|Assessments at enrollment and 3 months or time of final adjudication assessment (up to 6 months)|Patients who completed questionnaire at both time points|||score on a scale||Inter-Quartile Range|Median
2623773|NCT01928849|Secondary|Brief Pain Inventory (BPI) Short Form Score|The BPI short form is a multidimensional patient-completed measure that assesses the sensory component of pain intensity. We will analyze the change in average pain score question (ranges 0-10) and the sum of the 7 interference questions (total range 0-70) from baseline. Higher score indicates greater pain and interference.|Assessments at enrollment and 3 months or time of final adjudication assessment (up to 6 months)|Those completing questionnaires at both time points|||score on a scale||Inter-Quartile Range|Median
2623774|NCT01928849|Secondary|Effect on Analgesic Requirement|The effect of study drug on perioperative analgesic consumption and corresponding analysis of pain/sedation scales. Outcome defined as total opioid consumption (mg) during each 24-hour periods following surgery.|Assessments during hospitalization (0-24 hours and 24-48 hours post-surgery)|Patients who completed the study|||morphine milligram equivalents||Inter-Quartile Range|Median
2623775|NCT01928849|Secondary|Incidence of Pain Sub-types|The incidence of neuropathic limb or post-amputation pain sub-types as defined by adjudication classification at each assessment time point.|Assessments at enrollment and 3 months or time of final adjudication assessment (up to 6 months)|Participants who completed the study. For the cherry syrup (placebo) arm, only 50 participants completed the full adjudication process necessary to determine phantom pain sub-type.|||Participants|||Count of Participants
2623776|NCT01928849|Primary|Number of Patients With Chronic Post-amputation Pain|The primary endpoint is the incidence of chronic pain after surgery. The study team will use the average pain score over the past week as noted on the Self-Reported Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS) for the assessment of pain, and define chronic pain as a score greater than or equal to 3.|3 months or time of final adjudication assessment, up to 6 months|Participants who completed the study.|||Participants|||Count of Participants
2623777|NCT01928797|Secondary|Number of Participants With Umbilical Cord pH|Number of participants with Umbilical cord pH <7.2|Intraoperative|1 out of 30 babies had umbilical pH < 7.2|||number of participants|||Number
2623778|NCT01928797|Secondary|Nausea and Vomiting|incidence of nausea, and vomiting|intraoperatively during surgery|Nausea|||Participants|||Count of Participants
2623779|NCT01928797|Primary|Percentage of Participants With a Cardiac Output Within and Outside 20% of Baseline Values|"To determine mean cardiac output differences between the control group and the study group that used cardiac output data. In the control group, the cardiac output data was measured but not used for correcting blood pressure changes. Blood pressure changes were used for administering phenylephrine or ephedrine. In the study group, cardiac output data was used, in addition to blood pressure data, to correct both cardiac output and blood pressures to be maintained within 20% of baseline measurements.~After spinal anesthesia for cesarean delivery, the cardiac output and blood pressure tends to decrease. When this occurs, the blood flow to the uterus and the baby decrease resulting in fetal heart changes. Since we do not monitor the baby during the actual cesarean delivery (technically difficult), the strategy is to maintain the blood pressure and cardiac output within the 20% of the baseline values."|intraoperatively during surgery||||percentage of patients|||Number
2623780|NCT01928771|Secondary|Patient and Clinician's Responder Assessment to Treatment|CGIC (Clinical global impression of change), and PGIC (Patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using 7-point rating scale, ranging from 1 (very much improved), to 7 (very much worse). This is additional measures collected after second Amendment, thus not all patients had data to be analyzed.|Immediately following the first administration of study drug through Study Week 48|Full analysis set, Baseline eosinophils >=300/uL|||Participants|||Number
2623781|NCT01928771|Secondary|Number of Participants That Utilized Health Care Resources||Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300=/uL|||Participants|||Number
2623782|NCT01928771|Secondary|Mean Productivity Loss Due to Asthma in Classroom|WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable to patients who attending classes|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL who attending classes|||Percent of productivity loss||Standard Deviation|Mean
2623783|NCT01928771|Secondary|Mean Work Productivity Loss Due to Asthma|WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. The work productivity loss is only applicable to patients who employed, which is only subset of the study population.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL for patients who employed|||Percent of productivity loss||Standard Deviation|Mean
2623784|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in EQ-5D-5L VAS|EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||Scores on a scale||Standard Deviation|Mean
2623785|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in AQLQ(S)+12|AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||Scores on a scale||Standard Deviation|Mean
2623786|NCT01928771|Secondary|Extend of Exposure|Extend of exposure is defined as duration of treatment in days|Immediately following the first administration of study drug through Study Week 48.|Safety analysis set, note that 4 patients who were randomized to q.8 regimen treated with q.4 regimen. Thus 403 patients treated with q.4 rather than 399, 394 patients treated with q.8 rather than 398.|||Days||Standard Deviation|Mean
2623787|NCT01928771|Secondary|Immunogenicity of Benralizumab|Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post baseline assessments (with >=16 weeks between the first and the last positive) or positive at last post baseline assessment. Transiently positive is defined as having at least one post baseline ADA positive assessment and not fulfilling the conditions of persistently positive.|Pre-treatment until end of follow-up|Safety analysis set, note that 4 patients who were randomized to q.8 regimen treated with q.4 regimen. Thus 403 patients treated with q.4 rather than 399, 394 patients treated with q.8 rather than 398. However, data were only available for 402 patients in q.4, and 393 patients in q.8.|||Participants|||Number
2623788|NCT01928771|Secondary|Pharmacokinetics of Benralizumab|Mean PK concentrations at each visit|Baseline, week 4, week 4 day 6, week 8, week 16, week 24, week 32, week 40, week 48, week 56|PK analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2623789|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils <300/uL|ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils <300/uL|||Scores on a scale||Standard Deviation|Mean
2623790|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils >=300/uL|ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||Scores on a scale||Standard Deviation|Mean
2623791|NCT01928771|Secondary|Proportion of Night Awakening Due to Asthma|Change from baseline to Week 48 on proportion of night awakening due to asthma|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||Proportion of nights||Standard Deviation|Mean
2623792|NCT01928771|Secondary|Home Lung Function Assessment Based on Evening PEF|Change from baseline to week 48 in home lung function evening peak expiratory flow [PEF]|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||L/min||Standard Deviation|Mean
2623793|NCT01928771|Secondary|Home Lung Function Assessment Based on Morning PEF|Change from baseline to week 48 in home lung function morning peak expiratory flow [PEF]|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||L/min||Standard Deviation|Mean
2623794|NCT01928771|Secondary|Change in Asthma Rescue Medication|Change from baseline to week 48 in number of rescue medication use (puffs/day)|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||Puffs/day||Standard Deviation|Mean
2623795|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils <300/uL|Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils <300/uL|||Scores on a scale||Standard Deviation|Mean
2623796|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils >=300/uL|Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||Scores on a scale||Standard Deviation|Mean
2623797|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils <300/uL||Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinopiles <300/uL|||Liter||Standard Deviation|Mean
2623798|NCT01928771|Secondary|Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils >=300/uL||Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinopiles >=300/uL|||Liter||Standard Deviation|Mean
2623799|NCT01928771|Secondary|Time to First Asthma Exacerbation||Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||Days||95% Confidence Interval|Median
2623800|NCT01928771|Secondary|Number of Patients With >=1 Asthma Exacerbations||Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||Participants|||Number
2623801|NCT01928771|Secondary|Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations|The annual exacerbation rate associated with an emergency room visit or a hospitalization (adjudicated)|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||events/year||95% Confidence Interval|Least Squares Mean
2623895|NCT01928186|Secondary|Baseline FLT Transport (K1) Values by FLT PET|K1 (blood flow measure) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET|Baseline||||mL/min/mL||Full Range|Median
2623802|NCT01928771|Secondary|Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL|The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils <300/uL|||events/year||95% Confidence Interval|Least Squares Mean
2623803|NCT01928771|Primary|Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL|The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF|Immediately following the first administration of study drug through Study Week 48.|Full analysis set, Baseline eosinophils >=300/uL|||events/year||95% Confidence Interval|Least Squares Mean
2623804|NCT01928758|Other Pre-specified|Abstinence From Smoking|Smokers assigned to reduced nicotine content cigarettes will be more likely to successfully abstain from smoking at the end of the trial, based on all randomized participants, defined as no cigarette use in past 7 days, verified by exhaled carbon monoxide <10ppm.|Follow-up appointment 30 weeks after randomization (12 weeks after last visit of randomized trial phase).|All randomized participants|||Participants|||Count of Participants
2623805|NCT01928758|Other Pre-specified|Intention to Quit Smoking|Smokers assigned to the reduced nicotine content cigarette group may have lower perceived dependence and be more likely to report intention to quit smoking|At end of 18-week randomized trial phase|Participants who attended the visit at the end of the 18-week randomized trial phase|||Participants|||Count of Participants
2623806|NCT01928758|Secondary|Minnesota Nicotine Withdrawal Scale|This 8-item scale measures nicotine withdrawal symptoms and the scale range is from 0-32. Higher scores indicate higher severity.|Measured at the end of the last 3 weeks of randomization trial phase|Randomized trial phase completers with non-missing values for the outcome at both time points being used in the regression (complete case analysis).|||score on a scale||Standard Deviation|Mean
2623807|NCT01928758|Secondary|Perceived Stress Scale|10-item questionnaire measuring the degree to which life situations are appraised stressful. Scale range is 0-40. Higher scores indicate more stress.|Measured at the end of the last 3 weeks of randomization trial phase|Randomized trial phase completers with non-missing values for the outcome at both time points being used in the regression (complete case analysis).|||score on a scale||Standard Deviation|Mean
2623808|NCT01928758|Secondary|Quick Inventory of Depressive Symptomatology|A 16-item scale on depression symptoms. The scale range is 0-27 where 0 = Least Severe and 27 = Most Severe.|Measured at the end of the last 3 weeks of randomization trial phase|Randomized trial phase completers with non-missing values for the outcome at both time points being used in the regression (complete case analysis).|||score on a scale||Standard Deviation|Mean
2623809|NCT01928758|Primary|Plasma Cotinine Concentration|Plasma cotinine is a measure of daily nicotine exposure. Samples were measured in ng/mL.|Measured at the end of the last 3 weeks of randomization trial phase|Randomized trial phase completers with non-missing values for the outcome at both time points being used in the regression (complete case analysis).|||ng/mL||Standard Deviation|Mean
2623810|NCT01928719|Secondary|Cortisol|Salivary Cortisol Cortisol is produced by the hypothalamic-pituitary-adrenal axis (HPA) axis in response to stress. Peak cortisol measures during the cortisol awakening response were used.|15 weeks|A subset of participants was randomly selected to complete the cortisol collection procedure and those who provided usable samples 1-3 were used in this analysis|||ng/dl||95% Confidence Interval|Least Squares Mean
2623811|NCT01928719|Secondary|Perceived Stress|Perceived Stress is measured via the Perceived Stress Scale Score. The 10-item version was used. Scale range is 0-40. Higher scores indicate more stress.|18 weeks|All randomized participants|||score on a scale||95% Confidence Interval|Least Squares Mean
2623812|NCT01928719|Secondary|Smoke Exposure|Measured in carbon monoxide levels by expired CO|18 weeks|All randomized participants|||parts per million (ppm)||95% Confidence Interval|Least Squares Mean
2623813|NCT01928719|Secondary|Nicotine Exposure|Measured by cotinine (ng/ml) measured in plasma|18 weeks|All randomized participants|||ng/ml||95% Confidence Interval|Least Squares Mean
2623814|NCT01928719|Secondary|Cigarettes Per Day|Measured by self-reported cigarettes per day at in-person clinic visits using 6-day follow back|18 weeks|All randomized participants|||cigarettes per day||95% Confidence Interval|Least Squares Mean
2623815|NCT01928719|Secondary|Predictors of Participant Dropout|Baseline participant characteristics were evaluated for their association with the primary outcome, randomized trial phase dropout. The table below reports the number of participants who dropped out by each characteristic that was found to be univariately associated with the primary outcome.|18 weeks|Participants (who were randomized) are stratified according to the listed characteristics.|||Participants|||Count of Participants
2623816|NCT01928719|Primary|Number of Participants Who Dropped Out of Study as a Measure of Adherence|Adherence to the regimen was assessed via dropout (due to withdrawal or lost-to-follow up) during the randomized intervention trial phase of the study. Dropout was analyzed as a time-to-event outcome during the 18 weeks after randomization.|18 weeks|All randomized participants|||Participants|||Count of Participants
2623817|NCT01928693|Other Pre-specified|Number of Participants With Treatment Failure||29 days||||participants|||Number
2623818|NCT01928693|Other Pre-specified|Patient Pain Scores|Patients will be asked to grade the overall pain of the affected eye at each visit on a Scale= 0--None, 1- Mild, 2- Moderate, 3- Severe|Average of 6 times in a 29 day period||||units on a scale|||Number
2623819|NCT01928693|Other Pre-specified|Patient Satisfaction Scores|Patient satisfaction outcomes will be assessed using a series of survey questions ranging in both categorical and continuous outcomes. Treatment will be compared using either methods for differences in binomial proportions or the Wilcoxon Rank Sum test. Scale= 0- Very Comfortable, 1- Comfortable, 2- Uncomfortable, 3- Very Uncomfortable|Average of 6 times in a 29 day period||||units on a scale|||Number
2623820|NCT01928693|Other Pre-specified|Scarring|Scarring will be evaluated and measured in millimeters at Day 29 and classified as either peripheral or central.|29 days||||millimeters|||Number
2623821|NCT01928693|Other Pre-specified|Time to Treatment Failure.|If there is no reduction in size of the corneal ulcer by day 8, the treatment will be deemed a failure and alternative medications will be given at the discretion of the investigator.|8 days|Data was not collected because there were no treatment failures in any of the treatment arms||||||
2623829|NCT01928615|Secondary|Participant's Satisfaction With the Injection Site|Each participant was asked to rate their satisfaction with the 2 injection sites, thigh and upper arm, on a scale of 1 to 10, where 10 represents greater satisfaction. Ratings were made at the end of Cycles 10 and 14.|End of Cycles 10 and 14 (Weeks 30 and 42)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.~Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."||||||
2623830|NCT01928615|Secondary|Health Care Provider's Satisfaction With the Injection Site|The health care provider for each participant was asked to rate their satisfaction with the 2 injection sites, thigh and upper arm, on a scale of 1 to 10, where 10 represents greater satisfaction. Ratings were made at the end of Cycles 10 and 14.|End of Cycles 10 and 14 (Weeks 30 and 42)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.~Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."||||||
2623831|NCT01928615|Secondary|Disease-free Survival|Disease-free survival was defined as the time in months from Baseline to disease recurrence or death, whichever occurred first.|Baseline to the end of the study (up to 54 weeks)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.~Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."||||||
2623832|NCT01928615|Secondary|Overall Survival|Overall survival was defined as the time in months from Baseline to death from any cause.|Baseline to the end of the study (up to 54 weeks)|"Intent-to-treat population: All participants who received at least 1 dose of study medication.~Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."||||||
2623833|NCT01928615|Primary|Quality of Life Score|Participants rated their quality of life on a visual analog scale (VAS) at the end of each cycle for Cycles 7-14. The left-end of the VAS represented the lowest-rated quality of life and the right-end of the VAS represented the highest-rated quality of life. Both the mean ratings for injections into the thigh and the upper arm and the minimum ratings for during injections into the thigh and the upper arm are reported. Quality of life scores ranged from 1 to 100 with a higher score indicating a better rated quality of life.|Cycles 7-14 (Weeks 19-42, 24 weeks total)|"Modified intent-to-treat population: All participants who received at least 1 dose of study medication and who have at least 1 quality of life score in each treatment period (Cycles 7-10 and Cycle 11-14).~Due to the low enrollment (n = 2) and premature termination of the study, the Outcome Measure was not analyzed."||||||
2623834|NCT01928485|Secondary|Urinary Symptoms as Assessed by American Urological Association Symptom Index (AUA).|Urinary symptoms as assessed by AUA score. This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency. Scores range between 0 to 35, with higher scores indicating a worse clinical assessment.|At 52 weeks|||||||
2623835|NCT01928485|Secondary|Urinary Symptoms as Assessed by American Urological Association Symptom Index (AUA)|Urinary symptoms as assessed by American Urological Association Symptom Index (AUA). This is a 7-item symptom index measures frequency, nocturia, weakness of stream, hesitancy, intermittence, incomplete emptying and urgency. Scores range between 0 to 35, with higher scores indicating a worse clinical assessment.|At 26 weeks|||||||
2623836|NCT01928485|Secondary|Sexual Health Inventory in Men Score (SHIM Score)|"SHIM score - The SHIM score measures the severity of the participant's Erectile Dysfunction (ED) in points on a scale as follows:~22 - 25: No significant erectile dysfunction 17 - 21: Mild erectile dysfunction 12 - 16: Mild-to-moderate erectile dysfunction 8 - 11: Moderate erectile dysfunction 5 - 7: Severe erectile dysfunction"|At 52 weks|||||||
2623837|NCT01928485|Secondary|Sexual Health Inventory in Men Score (SHIM Score)|"SHIM score - The SHIM score measures the severity of the participant's Erectile Dysfunction (ED) in points on a scale as follows:~22 - 25: No significant erectile dysfunction 17 - 21: Mild erectile dysfunction 12 - 16: Mild-to-moderate erectile dysfunction 8 - 11: Moderate erectile dysfunction 5 - 7: Severe erectile dysfunction"|At 26 weeks|||||||
2623838|NCT01928485|Secondary|Quality of Life (QOL) Assessed by Medical Outcomes Study 12-item Short Form Health Survey (SF-12)|Quality of Life (QOL) assessed by SF-12. Quality of Life (QOL) assessed by SF-12. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.|At 52 weeks|||||||
2623839|NCT01928485|Secondary|Quality of Life (QOL) Assessed by Medical Outcomes Study 12-item Short Form Health Survey (SF-12)|Quality of Life (QOL) assessed by SF-12. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.|At 26 weeks|||||||
2623840|NCT01928485|Secondary|Quality of Life (QOL) Assessed by the Expanded Prostate Cancer Index Composite (EPIC-26)|Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.|at 52 weeks|||||||
2623841|NCT01928485|Secondary|Quality of Life (QOL) Assessed by the Expanded Prostate Cancer Index Composite (EPIC-26)|Quality of Life (QOL) assessed by the Expanded Prostate Cancer Index Composite (EPIC-26). Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.|At 26 weeks|||||||
2623842|NCT01928485|Secondary|Effects of Oral Ingestion of Sunphenon 90 DCF-T on Histologic Findings in Prostate Tissue Such as Nuclear Measurements Viz. Shape, Size and Texture|Effects of oral ingestion of Sunphenon 90 DCF-T on histologic findings in prostate tissue such as nuclear measurements viz. shape, size and texture|Up to 52 weeks|Could not be determined because there were no tumor cells in biopsy||||||
2623843|NCT01928485|Secondary|Effects of Oral Ingestion of Green Tea Extract on Levels of M30 Apoptosense in the Prostate Tissue|The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA.|Up to 52 weeks|M30 levels could not be determined because there were no tumor cells in biopsy||||||
2623896|NCT01928186|Secondary|Baseline Ki (Flux Constant) Values by FLT PET|Ki (flux constant) in breast tumor tissue as determined by the pre-therapy (baseline) FLT PET scan|Baseline||||mL/min/mL||Full Range|Median
2623844|NCT01928485|Secondary|Effects of Oral Ingestion of Green Tea Extract on Levels of CD34|The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA.|Up to 52 weeks|ROI staining scores could not be determined because no positive stained cells in post-biopsy specimens. Tissue from 3 participants in Arm A and 1 participant from Arm B was analysed.||||||
2623845|NCT01928485|Secondary|Effects of Oral Ingestion of Green Tea Extract on Levels of Ki-67|The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures ANOVA.|Up to 52 weeks|ROI staining scores could not be determined because no positive stained cells in post-biopsy specimens. Tissue from 3 participants in Arm A and 1 participant from Arm B was analysed.||||||
2623846|NCT01928485|Secondary|Effects of Oral Ingestion of Green Tea Extract in the Reactivation of GSTP1 (Whole Blood DNA)|The temporal pattern of biomarkers within same treatment group between baseline and subsequent time points will be analyzed using repeated measures analysis of variance (ANOVA).|Up to 52 weeks|||||||
2623847|NCT01928485|Primary|Changes in the Levels of Free-PSA (f-PSA)|The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.|from baseline at 52 weeks|Participants with available PSA values|||ng/mL||Standard Deviation|Mean
2623848|NCT01928485|Primary|Changes in the Level of VEGF|The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.|Baseline up to 52 weeks||||pg/mL||Standard Deviation|Mean
2623849|NCT01928485|Primary|Changes in the Level of IGFBP-3|The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.|Baseline to 52 weeks||||ng/mL||Standard Deviation|Mean
2623850|NCT01928485|Primary|Changes in the IGF-I/fPSA Ratio|The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.|Baseline up to 52 weeks||||ratio||Standard Deviation|Mean
2623851|NCT01928485|Primary|Changes in IGF-I Levels|The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.|Baseline to 52 weeks||||ng/mL||Standard Deviation|Mean
2623852|NCT01928485|Primary|Changes in the f/tPSA Ratio|The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.|From baseline at 52 weeks|Participants with available PSA values|||ratio||Standard Deviation|Mean
2623853|NCT01928485|Primary|Changes in the Levels of Total-PSA (tPSA)|The difference of serum biomarkers between two treatment arms will be compared using T-test or Kruskal-Wallis test if normality is violated.|From baseline at 52 weeks|Participants with available PSA values|||ng/mL||Standard Deviation|Mean
2623854|NCT01928472|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 to day 7 of vaccination of adjuvanted and unadjuvanted formulations of H7N9c vaccine.|Day 1 through Day 7 after each vaccination.|Analysis was done on the solicited safety set - All subjects in the exposed set with solicited AE data.|||participants|||Number
2623855|NCT01928472|Primary|Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine|The number of subjects reporting unsolicited adverse events after receiving adjuvanted and unadjuvanted formulations of H7N9c vaccine was reported. Safety was assessed as the number of subjects who reported SAEs, at least possibly related SAEs, new onset of chronic diseases (NOCDs), medically attended AEs, AEs of Special Interest (AESIs), AEs leading to withdrawal from the study were collected from day 1 to day 366 following vaccination with adjuvanted and unadjuvanted formulations of H7N9 vaccine.|Day 1 to Day 366.|Analysis was done on unsolicited safety set.|||participants|||Number
2623856|NCT01928472|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine|Safety was assessed as the number of subjects who reported any AEs, and at least possibly related AEs are collected from day 1 to day 43 following vaccination with adjuvanted and unadjuvanted formulations of H7N9c vaccine.|Day 1 to Day 43|Analysis was done on unsolicited safety set - All subjects in the exposed set with unsolicited AE data.|||participants|||Number
2623857|NCT01928472|Secondary|Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)|Percentages of subjects who achieved HI titers≥1:40 was measured at six months (day 183) and one year (day 366) after the first vaccination of a cell-culture derived H7N9 vaccine.|Day 183 and 366|FAS-Day 183 and FAS-Day 366|||Percentages of subjects||95% Confidence Interval|Number
2623858|NCT01928472|Secondary|Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)|"Percentage of subjects with HI seroconversion was measured as HI titer persistence at six months (day 183) and one year (day 366) after the first vaccination.~Seroconversion is defined as postvaccination HI titer>40 for subjects with baseline (day 1); HI titer <1:10 or a minimum four-fold increase in titer for subjects with baseline titer>1:10."|Day 183 and 366|FAS-Day 183 and FAS-Day 366|||Percentages of subjects||95% Confidence Interval|Number
2623859|NCT01928472|Secondary|Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)|GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs six months (day 183) and one year (day 366) after the first vaccination.|Day 183 and 366|FAS-Day 183 and FAS-Day 366|||Ratio||95% Confidence Interval|Geometric Mean
2623860|NCT01928472|Secondary|Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)|The immunogenicity was measured as GMTs in subjects as persistence at six months (day 183) and one year (day 366) after the first vaccination as measured by Hemagglutination Inhibition (HI) Assay.|Day 183 and 366.|FAS-Day 183 and FAS-Day 366|||Titers||95% Confidence Interval|Geometric Mean
2623861|NCT01928472|Secondary|Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)|Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after first (Day 22) vaccination.|Day 1 and 22.|FAS-Day 22|||Percentages of subjects||95% Confidence Interval|Number
2623862|NCT01928472|Secondary|Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)|"Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after first (day 22) vaccination.~Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10."|Day 22|FAS-Day 22|||Percentages of subjects||95% Confidence Interval|Number
2623863|NCT01928472|Secondary|Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22)|GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after first (day 22) vaccination.|Day 22|FAS-Day 22|||Ratio||95% Confidence Interval|Geometric Mean
2623864|NCT01928472|Secondary|Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22)|Immunogenicity was measured by HI assay and summarized through the GMTs at baseline (day 1) and three weeks after the first (day 22) vaccination.|Day 1 and 22|FAS-Day 22|||Titers||95% Confidence Interval|Geometric Mean
2623865|NCT01928472|Primary|Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)|Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination.|Day 1 and 43|FAS-Day 43.|||Percentages of subejcts||95% Confidence Interval|Number
2623866|NCT01928472|Primary|Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)|"Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after second (day 43) vaccination.~Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10."|Day 43|FAS-Day 43|||Percentages of subjects||95% Confidence Interval|Number
2623867|NCT01928472|Primary|Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43)|Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after second (day 43) vaccination.|Day 43|FAS-Day 43|||Ratio||95% Confidence Interval|Geometric Mean
2623868|NCT01928472|Primary|Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43)|Immunogenicity was measured by Hemagglutination Inhibition (HI) assay and summarized through the geometric mean titers (GMTs) at baseline (day 1) and three weeks after the second (day 43) vaccination|Day 1 and 43|The analysis was done on Full Analysis Set – Subjects who received at least one study vaccination and provided immunogenicity at day 43 (FAS-Day 43).|||Titers||95% Confidence Interval|Geometric Mean
2623869|NCT01928433|Secondary|The Safety and Tolerability of Multiple Doses of Finafloxacin: Number of Participants Who Discontinued Due to TEAE|This study will evaluate the safety of the different regimens of finafloxacin. The safety outcome measures assessed are the following: vital signs, physical examinations, ECGs, haematology, biochemistry, urinalysis, adverse events and serious adverse events. Adverse events and serious adverse events will be documented throughout the study for each group (including comparator group and the incidence and severity of their occurrence will be compared between all groups. The results of all other safety outcome measures will be compared with the baseline values of each group to determine if significant changes occurred during the course of the study within one group. The results at the different visits will also be compared between the groups to identify significant differences between the 3 treatment groups.|Screening to day 24|Safety (SAF) population includes all subjects with at least one administration of study drug.|||Participants|||Count of Participants
2623870|NCT01928433|Secondary|The Safety and Tolerability of Multiple Doses of Finafloxacin: Number of Treatment-emergent Adverse Events|This study will evaluate the safety of the different regimens of finafloxacin. The safety outcome measures assessed are the following: vital signs, physical examinations, ECGs, haematology, biochemistry, urinalysis, adverse events and serious adverse events. Adverse events and serious adverse events will be documented throughout the study for each group (including comparator group and the incidence and severity of their occurrence will be compared between all groups. The results of all other safety outcome measures will be compared with the baseline values of each group to determine if significant changes occurred during the course of the study within one group. The results at the different visits will also be compared between the groups to identify significant differences between the 3 treatment groups.|Screening to Day 24|Safety (SAF) population includes all subjects with at least one administration of study drug.|||Treatment-emergent AEs|||Number
2623871|NCT01928433|Secondary|Number of Participants With Clinical and Microbiological Response at the End of Study (EoS) Visit (Day 24).|The clinical and microbiological response as the efficacy parameter will be assessed for each group and will be compared between the three groups. Separate analyses will be performed for all time points for the clinical and microbiological responders and compared also between the different groups.|Day 24|The micro-ITT population is composed of all randomized patients who have a baseline bacterial pathogen on culture of urine or blood that causes UTI against which the investigational drug has antibacterial activity.|||Participants|||Count of Participants
2623872|NCT01928433|Secondary|Number of Participants With Clinical and Microbiological Response at the End of Therapy (EoT) Visit (Day 10).|The clinical and microbiological response as the efficacy parameter will be assessed for each group and will be compared between the three groups. Separate analyses will be performed for all time points for the clinical and microbiological responders and compared also between the different groups.|Day 10|The micro-ITT population is composed of all randomized patients who have a baseline bacterial pathogen on culture of urine or blood that causes UTI against which the investigational drug has antibacterial activity.|||Participants|||Count of Participants
2623873|NCT01928433|Secondary|Number of Participants With Clinical and Microbiological Response at the On Therapy (OT) Visit (Day 3).|The clinical and microbiological response as the efficacy parameter will be assessed for each group and will be compared between the three groups. Separate analyses will be performed for all time points for the clinical and microbiological responders and compared also between the different groups.|Day 3|The micro-ITT population is composed of all randomized patients who have a baseline bacterial pathogen on culture of urine or blood that causes UTI against which the investigational drug has antibacterial activity.|||Participants|||Count of Participants
2623874|NCT01928433|Primary|Number of Participants With Clinical and Microbiological Response|"The primary endpoint of this study is the clinical and microbiological response of patients with cUTI or pyelonephritis to treatment with finafloxacin for 5 days versus finafloxacin for 10 days versus ciprofloxacin for 10 days as a reference comparator at the Test of Cure (ToC) visit (Day 17) in the microbiological intent-to-treat population (micro-ITT population).~Clinical response is defined as resolution of the symptoms of cUTI present at trial entry and no new symptoms developed. Microbiological response is defined as elimination or reduction of study entry pathogens to ≤ 10e3 CFU/mL on urine culture. The clinical and microbiological response will be assessed for each group on Day 17 and will be compared between the three groups to assess the efficacy in each group."|Day 17|The micro-ITT population is composed of all randomized patients who have a baseline bacterial pathogen on culture of urine or blood that causes UTI against which the investigational drug has antibacterial activity.|||Participants|||Count of Participants
2623875|NCT01928394|Primary|Objective Response Rate ( ORR )|The number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.|60 months|All Treated Participants|||Percentage of Participants||95% Confidence Interval|Number
2623876|NCT01928381|Post-Hoc|Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Score Indicates Worse Pain - Per Protocol|Brief pain Index - diabetic painful neuropathy (BPI-DPN) - average daily pain, Item 5 (final 2 day home diary + in clinic assessment at end of 3 week treatment)|3 weeks of treatment|Per Protocol|||Average daily pain score||Standard Error|Least Squares Mean
2623877|NCT01928381|Primary|Brief Pain Index - Item 5, Average Daily Pain Score (Range 0-10) Higher Values Indicate Worse Pain|Brief pain Index - diabetic painful neuropathy (BPI-DPN) - average daily pain, Item 5 (final 2 day diary + in clinic assessment at end of 3 week treatment period)|3 weeks of treatment|Full Analysis set|||Average daily pain score||Standard Error|Least Squares Mean
2623878|NCT01928329|Secondary|Major Hypoglycemic Event Rate Off Drug|The hypoglycemic event rate was calculated for patients while on and off study drug. The event rate is calculated using the number of events divided by the number of months either on or off study drug. Major hypoglycemic events are categorized as an event with a blood glucose level < 55 mg/dL.|Up to 12 months|Only those randomized that received study drug and were followed through study completion.|||events per month||Full Range|Median
2623879|NCT01928329|Secondary|Major Hypoglycemic Event Rate On Drug|The hypoglycemic event rate was calculated for patients while on and off study drug. The event rate is calculated using the number of events divided by the number of months either on or off study drug. Major hypoglycemic events are categorized as an event with a blood glucose level < 55 mg/dL.|Up to 6 months|Only those randomized that received study drug.|||events per month||Full Range|Median
2623880|NCT01928329|Secondary|Change From Baseline in HbA1c Levels||12 months|Intention to treat analysis.|||mmol/mol||Standard Error|Least Squares Mean
2623881|NCT01928329|Primary|Change From Baseline in HbA1c Levels||6 months|Intention to treat analysis|||mmol/mol||Standard Error|Least Squares Mean
2623882|NCT01928290|Secondary|Toxicity and Tolerability (Arm A and Arm B) as Measured by the Number of Participants With Grade 3 or Higher Adverse Events||30 days after completion of treatment (estimated to be 5 months)||||participants|||Number
2623883|NCT01928290|Secondary|Duration of Response (Arm A Only)|Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented|Through 1 year after completion of treatment (estimated to be 16 months)||2020-10-31|10/2020||||
2623884|NCT01928290|Secondary|Clinical Benefit Rate|"Clinical benefit rate is the percentage of combined patients who have achieved complete response (CR), partial response (PR), and stable disease (SD)~CR: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm~PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|Through completion of treatment (estimated to be 4 months)||||Participants|||Count of Participants
2623885|NCT01928290|Secondary|Overall Survival (OS) Arm A Only)|Overall survival is defined as the time interval from date of diagnosis to date of death from any cause.|Through 1 year after completion of treatment (estimated to be 16 months)||2021-06-30|06/2021||||
2623886|NCT01928290|Secondary|Time to Progression (TTP) (Arm A Only)|Duration of time from start of treatment to time of progression. Progression is defined as At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Through 1 year after completion of treatment (estimated to be 16 months)||2020-10-31|10/2020||||
2623887|NCT01928290|Secondary|Progression Free Survival (Arm A Only)|Duration of time from start of treatment to time of progression or death, whichever occurs first.|Through 1 year after completion of treatment (estimated to be 16 months)||2020-10-31|10/2020||||
2623888|NCT01928290|Primary|Number of Participants With an Objective Response|"Objective response (defined as complete response (CR) + partial response (PR) by RECIST 1.1 criteria)~CR: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|Through completion of treatment (estimated to be 4 months)||||Participants|||Count of Participants
2623889|NCT01928186|Other Pre-specified|Pre-treatment Gene Expression Levels|Analyzed using BeadStudio software. Four clustering metrics for calculating dissimilarities (correlation, absolute correlation, Euclidean, and Manhattan) are available in BeadStudio and will be applied using standard analysis methods and diagnostics in BioConductor. To focus the analysis, proposed gene sets will be examined based on biological pathways and molecular signatures.|Baseline|||||||
2623890|NCT01928186|Other Pre-specified|Post-treatment Gene Expression Levels|Analyzed using BeadStudio software. Four clustering metrics for calculating dissimilarities (correlation, absolute correlation, Euclidean, and Manhattan) are available in BeadStudio and will be applied using standard analysis methods and diagnostics in BioConductor. To focus the analysis, proposed gene sets will be examined based on biological pathways and molecular signatures.|1 to 6 weeks post-therapy start|||||||
2623898|NCT01928186|Primary|Percentage Change in Ki-67 Positive Cells Between Pre-therapy and Post-therapy Tumor Specimens|"Tumor tissue samples from pre-treatment (baseline) biopsy and post-treatment surgery are stained using immuno-histochemistry techniques to visualize dividing cells expressing the Ki-67 protein, which is a cellular marker for proliferation.~The % values of positive cells from the baseline and post-treatment samples are then compared for each individual patient.~Association between Ki-67 and KFLT decline will be analyzed to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response."|Baseline to up to 6 weeks||||% change||Full Range|Median
2623899|NCT01928186|Primary|Percentage of Ki-67 Positive Tumor Cells in Surgical (Post-therapy) Sample|Surgically removed breast tumor tissue is stained using immuno-histochemistry techniques to visualize dividing cells expressing the Ki-67 protein, which is a cellular marker for proliferation.|1 to 6 weeks post-therapy start||||% stained cells||Full Range|Median
2623900|NCT01928186|Primary|Percent Change in SUV by FLT PET|Percent change between pre-treatment (baseline) and post-therapy measurements of FLT standardized uptake value (SUV) in breast tumors will be computed.|Baseline to up to 6 weeks||||% change||Full Range|Median
2623901|NCT01928186|Primary|Percent Change in Net Influx Constant (Ki) by FLT PET|"Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed.~Association between Ki-67 and Ki by FLT (KFLT) decline will be analyzed using the mid-P adjustment to Fisher's exact test to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response."|Baseline to up to 6 weeks||||% change||Full Range|Median
2623902|NCT01928082|Other Pre-specified|Serum Procollagen Type 1 N-terminal Propeptide|It is not available because the study was terminated|4 weeks, 8 weeks|Not available because the study was terminated||||||
2623903|NCT01928082|Other Pre-specified|Serum C-telopeptides of Type 1 Collagen|Not available because the study was terminated|4 weeks, 8 weeks|Not available because the study was terminated||||||
2623904|NCT01928082|Other Pre-specified|Serum Bone-specific Alkaline Phosphatase|Not available because the study was terminated|4 weeks, 8 weeks|Not available because the study was terminated||||||
2623905|NCT01928082|Other Pre-specified|Serum Osteocalcin|Not available because the study was terminated|4 weeks, 8 weeks|Not available because the study was terminated||||||
2623906|NCT01928082|Other Pre-specified|Serum Phosphorus|Not available because the study was terminated|4 weeks, 8 weeks|Not available because the study was terminated||||||
2623907|NCT01928082|Other Pre-specified|Serum Parathyroid Hormone|Not available because the study was terminated|4 weeks, 8 weeks|Not available because the study was terminated||||||
2623908|NCT01928082|Other Pre-specified|Serum 25 Hydroxyvitamin D|Not available because the study was terminated|4 weeks, 8 weeks|Not available because the study was terminated||||||
2623909|NCT01928082|Other Pre-specified|Calculated Tubular Resorption of Calcium|Not available because the study was terminated|4 weeks, 8 weeks|Not available because the study was terminated||||||
2623910|NCT01928082|Other Pre-specified|Calculated Serum Ionized Calcium|Not available because the study was terminated|4 weeks, 8 weeks|Not available because the study was terminated||||||
2623911|NCT01928082|Other Pre-specified|Serum Total Calcium|Not available because the study was terminated|4 weeks, 8 weeks|Not available because the study was terminated||||||
2623912|NCT01928082|Other Pre-specified|Serum Estradiol|Not available because the study was terminated|4 weeks, 8 weeks|Not available because the study was terminated||||||
2623913|NCT01928082|Secondary|Serum Sclerostin|Not available because the study was terminated|4 weeks, 8 weeks|Not available because the study was terminated||||||
2623914|NCT01928082|Secondary|Serum Bone Morphogenetic Protein 2|Not available because the study was terminated|4 weeks, 8 weeks|the study was terminated||||||
2623915|NCT01928082|Secondary|Serum 1,25-dihydroxyvitamin D3|0 participants were analyzed because the study was terminated|4 weeks, 8 weeks|The study was terminated||||||
2623916|NCT01928082|Primary|Absolute Change in 24 Hour Urinary Calcium Excretion|0 participants were measured because the study was terminated|4 weeks, 8 weeks|0 participants were analyzed because the study was terminated||||||
2623917|NCT01928030|Secondary|Reduction in Forearm Volume|Number of patients that achieve a clinically significant reduction in lymphedema, assessed as a 20% reduction in excess forearm volume|Up to 1 year|No participants received 900 units rHuPH20, and the MTD was not determined, so no participants received rHuPH20 at the MTD.|||Participants|||Count of Participants
2623918|NCT01928030|Primary|Treatment-related Adverse Events|Reported as any untoward medical occurrence or worsening of a pre-existing medical condition in a participant administered recombinant human hyaluronidase, and judged possibly, probably, or definitely related to treatment|Up to 1 year||||Participants|||Count of Participants
2623919|NCT01927887|Primary|Primary Efficacy Parameters of Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)|Using pathology as the gold standard the excised nodes will be correlated to histopathologic assessment and the primary efficacy parameters of LSN MRI will be determined for nodal staging. Specificity was determined by assessing the percentage of true negative nodes using pathology as a gold standard.|2 years||||percentage of true negative nodes||95% Confidence Interval|Number
2623920|NCT01927887|Primary|Primary Efficacy Parameters of Sensitivity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)|Using pathology as the gold standard the excised nodes will be correlated to histopathologic assessment and the primary efficacy parameters of LSN MRI will be determined for nodal staging|2 Years||||percentage of excised nodes||95% Confidence Interval|Number
2623921|NCT01927861|Secondary|Change in ECG|The ECG was recorded after a 3-minute rest in supine position at baseline (within 4 weeks prior to week 0) and week 208 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 208 are presented. Missing values were imputed using the LOCF method.|Baseline, week 208|SAS.|||Participants|||Count of Participants
2623922|NCT01927861|Secondary|Change in Blood Coagulation Test (Prothrombin Time and APTT)|Change from baseline (within 4 weeks prior to week 0) in blood coagulation test parameters: prothrombin time and APTT. Missing values were imputed using the LOCF method.|Baseline, week 208|SAS.|||sec||Full Range|Median
2623923|NCT01927861|Secondary|Change in Urinalysis (Protein, Glucose and Occult Blood)|The urinalysis was the measurements of protein, glucose, and occult blood at baseline (within 4 weeks prior to week 0) and week 208 and categorised as negative, trace, 1+, 2+ and 3+. Number of participants in each category at baseline and week 208 are presented. Missing values were imputed using the LOCF method.|Baseline, week 208|SAS.|||Participants|||Count of Participants
2623924|NCT01927861|Secondary|Change in Vital Signs (Pulse)|Pulse was measured after a 5-minute rest in sitting position. Change from baseline (week 0) in pulse. Missing values were imputed using the LOCF method.|Baseline, week 208|SAS. Number analyzed = participants with available data.|||beats/min||Standard Deviation|Mean
2623925|NCT01927861|Secondary|Change in Vital Signs (Diastolic Blood Pressure and Systolic Blood Pressure)|Systolic and diastolic blood pressure were measured after a 5-minute rest in sitting position. Change from baseline (week 0) in systolic blood pressure and diastolic blood pressure. Missing values were imputed using the LOCF method.|Baseline, week 208|SAS. Number analyzed = participants with available data.|||mmHg||Standard Deviation|Mean
2623926|NCT01927861|Secondary|Yearly Change in Bone Age/Change in Chronological Age|X-ray picture of carpal bones of left hand was taken for bone age determination. Centralised evaluation of bone age was done by the RUS score method of Tanner-Whitehouse II (TW2). Yearly change from week 156 in bone age/change in chronological age was presented.|Week 156, week 208|SAS. Number analyzed = participants with available data.|||Ratio (bone age/chronological age)||Standard Deviation|Mean
2623927|NCT01927861|Secondary|Yearly Change in Bone Age/Change in Chronological Age|X-ray picture of carpal bones of left hand was taken for bone age determination. Centralised evaluation of bone age was done by the RUS score method of Tanner-Whitehouse II (TW2). Yearly change from week 104 in bone age/change in chronological age was presented.|Week 104, week 156|SAS. Number analyzed = participants with available data.|||Ratio (bone age/chronological age)||Standard Deviation|Mean
2623928|NCT01927861|Secondary|Change in Bone Age/Chronological Age|X-ray picture of carpal bones of left hand was taken for bone age determination. Centralised evaluation of bone age was done by the RUS score method of Tanner-Whitehouse II (TW2). Change from baseline (week 0) in bone age/chronological age.|Baseline, week 208|SAS. Number analyzed = participants with available data.|||Ratio (bone age/chronological age)||Standard Deviation|Mean
2623929|NCT01927861|Secondary|Change in Bone Age|X-ray picture of carpal bones of left hand was taken for bone age determination. Centralised evaluation of bone age was done by the RUS score method of Tanner-Whitehouse II (TW2). Change from baseline (week 0) in bone age.|Baseline, week 208|SAS. Number analyzed = participants with available data.|||Years||Standard Deviation|Mean
2623930|NCT01927861|Secondary|Change in Glucose Tolerance (AUC of Insulin) Based on the OGTT|AUC of insulin was calculated by the trapezoidal method. Change from baseline (within 4 weeks prior to week 0) in glucose tolerance (AUC of insulin: 30, 60, 90 and 120 min after oral glucose load) at week 208 was evaluated based on the OGTT. Change from baseline results are presented as 'ratio to baseline'.|Baseline, week 208|SAS. Number analyzed = participants with available data.|||Ratio of AUC||Geometric Coefficient of Variation|Geometric Mean
2623931|NCT01927861|Secondary|Change in Glucose Tolerance (AUC of Glucose) Based on the OGTT|AUC of glucose was calculated by the trapezoidal method. Change from baseline (within 4 weeks prior to week 0) in glucose tolerance (AUC of glucose: 30, 60, 90 and 120 min after oral glucose load) at week 208 was evaluated based on the OGTT. Change from baseline results are presented as 'ratio to baseline'.|Baseline, week 208|SAS. Number analyzed = participants with available data.|||Ratio of AUC||Geometric Coefficient of Variation|Geometric Mean
2623932|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Biochemistry: Creatinine)|Change from baseline (within 4 weeks prior to week 0) in biochemical parameters - creatinine. Missing values were imputed using the LOCF method.|Baseline, week 208|SAS.|||umol/L||Standard Deviation|Mean
2623933|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Biochemistry: Blood Urea Nitrogen, Sodium, Potassium, Chloride, Total Calcium and Phosphorus)|Change from baseline (within 4 weeks prior to week 0) in biochemical parameters - blood urea nitrogen, sodium, potassium, chloride, total calcium and phosphorus. Missing values were imputed using the LOCF method.|Baseline, week 208|SAS. Number analyzed = participants with available data.|||mmol/L||Standard Deviation|Mean
2623934|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Biochemistry: Total Protein)|Change from baseline (within 4 weeks prior to week 0) in biochemical parameter - total protein. Missing values were imputed using the LOCF method.|Baseline, week 208|SAS. Number analyzed = participants with available data.|||g/dL||Standard Deviation|Mean
2623935|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Biochemistry: AST, ALT, r-GTP and Alkaline Phosphatase)|Change from baseline (within 4 weeks prior to week 0) in biochemical parameters - AST, ALT, r-GTP and alkaline phosphatase. Missing values were imputed using the LOCF method.|Baseline, week 208|SAS. Number analyzed = participants with available data.|||U/L||Standard Deviation|Mean
2623936|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Lipids: Total Cholesterol, LDL Cholesterol and HDL Cholesterol)|Change from baseline (within 4 weeks prior to week 0) in lipids: total cholesterol, LDL cholesterol and HDL cholesterol. Missing values were imputed using the LOCF method.|Baseline, week 208|SAS.|||mmol/L||Standard Deviation|Mean
2623937|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Haematology: Basophils)|Change from baseline (within 4 weeks prior to week 0) in haematological parameter - basophils. Missing values were imputed using the LOCF method.|Baseline, week 208|SAS.|||Percentage of basophils||Standard Deviation|Mean
2623938|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Haematology: Eosinophils)|Change from baseline (within 4 weeks prior to week 0) in haematological parameter - eosinophils. Missing values were imputed using the LOCF method.|Baseline, week 208|SAS.|||Percentage of eosinophils||Standard Deviation|Mean
2623939|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Haematology: Monocytes)|Change from baseline (within 4 weeks prior to week 0) in haematological parameter - monocytes. Missing values were imputed using the LOCF method.|Baseline, week 208|SAS.|||Percentage of monocytes||Standard Deviation|Mean
2623940|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Haematology: Lymphocytes)|Change from baseline (within 4 weeks prior to week 0) in haematological parameter - lymphocytes. Missing values were imputed using the LOCF method.|Baseline, week 208|SAS.|||Percentage of lymphocytes||Standard Deviation|Mean
2623944|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Haematology: Leukocytes and Thrombocytes)|Change from baseline (within 4 weeks prior to week 0) in haematological parameter - leukocytes and thrombocytes. Missing values were imputed using the LOCF method.|Baseline, Week 208|SAS. Number analyzed = participants with available data.|||10^9 cells/L||Standard Deviation|Mean
2623945|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Haematology: Erythrocytes)|Change from baseline (within 4 weeks prior to week 0) in haematological parameter - erythrocytes. Missing values were imputed using the LOCF method.|Baseline, week 208|SAS.|||10^12 cells/L||Standard Deviation|Mean
2623946|NCT01927861|Secondary|Change in HbA1c|Change from baseline (within 4 weeks prior to week 0) in HbA1c was evaluated after 208 weeks of treatment.|Baseline, week 208|SAS. Number analyzed = participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2623947|NCT01927861|Secondary|Change in IGF-I|Change from baseline (within 4 weeks prior to week 0) in IGF-I was evaluated after 208 weeks of treatment. Missing values were imputed using the LOCF method.|Baseline, week 208|SAS.|||ng/mL||Standard Deviation|Mean
2623948|NCT01927861|Secondary|Incidence of Treatment Emergent AEs|A treatment emergent AE (TEAE) was defined as an event that had onset date on or after the date of visit 2 (week 0; start of treatment) and no later than 7 days after the last day of NN-220 treatment.|Week 0 to week 234 (208 weeks treatment period + 26 weeks extended treatment period) + 7 days (follow-up period)|SAS.|||Events|||Number
2623949|NCT01927861|Secondary|Height Velocity SDS|Height velocity is change in height per year. The height velocity was calculated as the difference between current height (week 208) and height at week 156 divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using the formula: SDS = (height velocity - mean)/SD, where height velocity was the height velocity variable measured, mean and SD of height velocity by sex and age for the reference population. The scores were centered around zero. Positive SDS indicated greater height velocity and negative SDS indicated lesser height velocity than the mean of the reference population.|Week 156 to week 208|FAS.|||Standard deviation score||Standard Deviation|Mean
2623950|NCT01927861|Secondary|Height Velocity SDS|Height velocity is change in height per year. The height velocity was calculated as the difference between current height (week 156) and height at week 104 divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using the formula: SDS = (height velocity - mean)/SD, where height velocity was the height velocity variable measured, mean and SD of height velocity by sex and age for the reference population. The scores were centered around zero. Positive SDS indicated greater height velocity and negative SDS indicated lesser height velocity than the mean of the reference population.|Week 104 to week 156|FAS.|||Standard deviation score||Standard Deviation|Mean
2623951|NCT01927861|Secondary|Height Velocity|Height velocity is change in height per year. The height velocity was calculated as the difference between current height (week 208) and height at week 156 divided by time between those measurement time points and multiplied by 365 days. Missing values were imputed using the LOCF method.|Week 156 to week 208|FAS.|||cm/year||Standard Deviation|Mean
2623952|NCT01927861|Secondary|Height Velocity|Height velocity is change in height per year. The height velocity was calculated as the difference between current height (week 156) and height at week 104 divided by time between those measurement time points and multiplied by 365 days. Missing values were imputed using the LOCF method.|Week 104 to week 156|FAS.|||cm/year||Standard Deviation|Mean
2623953|NCT01927861|Secondary|Change in Height SDS (Noonan Syndrome Reference Data in Japanese)|Height SDS was calculated using the formula: Z=[(value/M)^L-1]/(S*L); where L, M and S are skewness (L), median (M) and coefficient of variation (S) of Japanese Noonan syndrome' height provided for each sex and age. For each participant, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The scores were centered around zero. Positive SDS indicated greater height and negative SDS indicated lesser height than the mean of the reference population. The change from baseline (week 0) in the height SDS after 208 weeks of treatment was analysed. Positive value in change from baseline indicated that SDS was better than baseline SDS. Missing values were imputed using the LOCF method.|Baseline, week 208|FAS.|||Standard deviation score||Standard Deviation|Mean
2623954|NCT01927861|Secondary|Change in Height SDS (Japanese National Reference Data)|Height SDS was calculated using the formula: SDS = (height - mean)/SD, where height was the height variable measured, mean and SD of height by sex and age for the reference population. The scores were centered around zero. Positive SDS indicated greater height and negative SDS indicated lesser height than the mean of the reference population. The change from baseline (week 0) in the height SDS after 208 weeks of treatment was analysed. Positive value in change from baseline indicated that SDS was better than baseline SDS. Missing values were imputed using the LOCF method.|Baseline, week 208|FAS.|||Standard deviation score||Standard Deviation|Mean
2623955|NCT01927861|Secondary|Change in ECG|The ECG was recorded after a 3-minute rest in supine position at baseline (within 4 weeks prior to week 0) and week 104 and categorised as normal, abnormal NCS (not clinically significant) or abnormal CS (clinically significant). Number of participants in each ECG category at baseline and week 104 are presented. Missing values were imputed using the LOCF method.|Baseline, week 104|SAS.|||Participants|||Count of Participants
2623956|NCT01927861|Secondary|Change in Blood Coagulation Test (Prothrombin Time and APTT)|Change from baseline (within 4 weeks prior to week 0) in blood coagulation test parameters: Prothrombin time and APTT (activated partial thromboplastin time). Missing values were imputed using the LOCF method.|Baseline, week 104|SAS.|||Second (sec)||Full Range|Median
2623957|NCT01927861|Secondary|Change in Urinalysis (Protein, Glucose and Occult Blood)|The urinalysis was the measurements of protein, glucose, and occult blood at baseline (within 4 weeks prior to week 0) and week 104 and categorised as negative, trace, 1+, 2+ and 3+. Missing values were imputed using the LOCF method. Number of participants in each category at baseline and week 104 are presented.|Baseline, week 104|SAS.|||Participants|||Count of Participants
2623958|NCT01927861|Secondary|Change in Vital Signs (Pulse)|Pulse was measured after a 5-minute rest in sitting position. Change from baseline (week 0) in pulse.|Baseline, week 104|SAS. Number analyzed = participants with available data.|||Beats per minute (beats/min)||Standard Deviation|Mean
2624119|NCT01926028|Secondary|Time to First VVC Episode From Study Day 17 to 360 - Participants <40 Years Old|Time-to-onset of first VVC episode from Study Day 17 for the NDV-3A vaccine group and the placebo group|12 months|Participants < 40 years old|||Days||Inter-Quartile Range|Median
2623959|NCT01927861|Secondary|Change in Vital Signs (Diastolic Blood Pressure and Systolic Blood Pressure)|Systolic and diastolic blood pressure were measured after a 5-minute rest in sitting position. Change from baseline (week 0) in systolic blood pressure and diastolic blood pressure.|Baseline, week 104|SAS. Number analyzed = participants with available data.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2623960|NCT01927861|Secondary|Yearly Change in Bone Age/Change in Chronological Age|X-ray picture of carpal bones of left hand was taken for bone age determination. Centralised evaluation of bone age was done by the RUS score method of Tanner-Whitehouse II (TW2). Yearly change from week 52 in bone age/change in chronological age was presented.|Week 52, week 104|SAS.|||Ratio (bone age/chronological age)||Standard Deviation|Mean
2623961|NCT01927861|Secondary|Yearly Change in Bone Age/Change in Chronological Age|X-ray picture of carpal bones of left hand was taken for bone age determination. Centralised evaluation of bone age was done by the RUS score method of Tanner-Whitehouse II (TW2). Yearly change from baseline (week 0) in bone age/change in chronological age was presented.|Baseline, week 52|SAS.|||Ratio (bone age/chronological age)||Standard Deviation|Mean
2623962|NCT01927861|Secondary|Change in Bone Age/Chronological Age|X-ray picture of carpal bones of left hand was taken for bone age determination. Centralised evaluation of bone age was done by the RUS score method of Tanner-Whitehouse II (TW2). Change from baseline (week 0) in bone age/chronological age.|Baseline, week 104|SAS.|||Ratio (bone age/chronological age)||Standard Deviation|Mean
2623963|NCT01927861|Secondary|Change in Bone Age|X-ray picture of carpal bones of left hand was taken for bone age determination. Centralised evaluation of bone age was done by the radius, ulna and short bones (RUS) score method of Tanner-Whitehouse II (TW2). Change from baseline (week 0) in bone age.|Baseline, week 104|SAS.|||Years||Standard Deviation|Mean
2623964|NCT01927861|Secondary|Change in Glucose Tolerance (AUC of Insulin) Based on the OGTT|AUC of insulin was calculated by the trapezoidal method. Change from baseline (within 4 weeks prior to week 0) in glucose tolerance (AUC of insulin: 30, 60, 90 and 120 min after oral glucose load) at week 104 was evaluated based on the OGTT. Change from baseline results are presented as 'ratio to baseline'.|Baseline, week 104|SAS. Number analyzed = participants with available data.|||Ratio of AUC||Geometric Coefficient of Variation|Geometric Mean
2623965|NCT01927861|Secondary|Change in Glucose Tolerance (AUC of Glucose) Based on the OGTT|AUC (area under the curve) of glucose was calculated by the trapezoidal method. Change from baseline (within 4 weeks prior to week 0) in glucose tolerance (AUC of glucose: 30, 60, 90 and 120 min after oral glucose load) at week 104 was evaluated based on the oral glucose tolerance test (OGTT). Change from baseline results are presented as 'ratio to baseline'.|Baseline, week 104|SAS.|||Ratio of AUC||Geometric Coefficient of Variation|Geometric Mean
2623966|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Biochemistry: Creatinine)|Change from baseline (within 4 weeks prior to week 0) in biochemical parameter - creatinine. Missing values were imputed using the LOCF method.|Baseline, Week 104|SAS.|||Micromoles per liter (umol/L)||Standard Deviation|Mean
2623967|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Biochemistry: Blood Urea Nitrogen, Sodium, Potassium, Chloride, Total Calcium and Phosphorus)|Change from baseline (within 4 weeks prior to week 0) in biochemical parameters - blood urea nitrogen, sodium, potassium, chloride, total calcium and phosphorus. Missing values were imputed using the LOCF method.|Baseline, week 104|SAS. Number analyzed = participants with available data.|||mmol/L||Standard Deviation|Mean
2623968|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Biochemistry: Total Protein)|Change from baseline (within 4 weeks prior to week 0) in biochemical parameter - total protein. Missing values were imputed using the LOCF method.|Baseline, week 104|SAS. Number analyzed = participants with available data.|||Grams per deciliter (g/dL)||Standard Deviation|Mean
2623969|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Biochemistry: AST, ALT, r-GTP and Alkaline Phosphatase)|Change from baseline (within 4 weeks prior to week 0) in biochemical parameters - aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (r-GTP) and alkaline phosphatase. Missing values were imputed using the LOCF method.|Baseline, week 104|SAS. Number analyzed = participants with available data.|||Units per liter (U/L)||Standard Deviation|Mean
2623970|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Lipids: Total Cholesterol, LDL Cholesterol and HDL Cholesterol)|Change from baseline (within 4 weeks prior to week 0) in lipids: total cholesterol, LDL (low-density lipoprotein) cholesterol and HDL (high-density lipoprotein) cholesterol. Missing values were imputed using the LOCF method.|Baseline, week 104|SAS.|||mmol/L||Standard Deviation|Mean
2623971|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Haematology: Basophils)|Change from baseline (within 4 weeks prior to week 0) in haematological parameter - basophils. Missing values were imputed using the LOCF method.|Baseline, week 104|SAS.|||Percentage of basophils||Standard Deviation|Mean
2623972|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Haematology: Eosinophils)|Change from baseline (within 4 weeks prior to week 0) in haematological parameter - eosinophils. Missing values were imputed using the LOCF method.|Baseline, week 104|SAS.|||Percentage of eosinophils||Standard Deviation|Mean
2623973|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Haematology: Monocytes)|Change from baseline (within 4 weeks prior to week 0) in haematological parameter - monocytes. Missing values were imputed using the LOCF method.|Baseline, week 104|SAS.|||Percentage of monocytes||Standard Deviation|Mean
2623974|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Haematology: Lymphocytes)|Change from baseline (within 4 weeks prior to week 0) in haematological parameter - lymphocytes. Missing values were imputed using the LOCF method.|Baseline, week 104|SAS.|||Percentage of lymphocytes||Standard Deviation|Mean
2623975|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Haematology: Neutrophils)|Change from baseline (within 4 weeks prior to week 0) in haematological parameter - neutrophils. Missing values were imputed using the LOCF method.|Baseline, week 104|SAS.|||Percentage of neutrophils||Standard Deviation|Mean
2623976|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Haematology: Haematocrit)|Change from baseline (within 4 weeks prior to week 0) in haematological parameter - haematocrit. Missing values were imputed using the LOCF method.|Baseline, week 104|SAS.|||Percentage of red blood cells||Standard Deviation|Mean
2625993|NCT01906866|Secondary|The Number of Awakenings During the Night Will be Measured for the Circadin 2/5 mg and Placebo by a Sleep and Nap Diary After 13 Weeks of Double-blind Treatment.|Questionnaire|up to 1.5 years|||||||
2623977|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Haematology: Haemoglobin)|Change from baseline (within 4 weeks prior to week 0) in haematological parameter - haemoglobin. Missing values were imputed using the LOCF method.|Baseline, week 104|SAS.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2623978|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Haematology: Leukocytes and Thrombocytes)|Change from baseline (within 4 weeks prior to week 0) in haematological parameter - leukocytes and thrombocytes. Missing values were imputed using the LOCF method.|Baseline, week 104|SAS. Number analyzed = participants with available data.|||10^9 cells per liter (10^9 cells/L)||Standard Deviation|Mean
2623979|NCT01927861|Secondary|Change in Clinical Laboratory Tests (Haematology: Erythrocytes)|Change from baseline (within 4 weeks prior to week 0) in haematological parameter - erythrocytes. Missing values were imputed using the LOCF method.|Baseline, week 104|SAS.|||10^12 cells per liter (10^12 cells/L)||Standard Deviation|Mean
2623980|NCT01927861|Secondary|Change in HbA1c (Glycosylated Haemoglobin)|Change from baseline (within 4 weeks prior to week 0) in HbA1c was evaluated after 104 weeks of treatment.|Baseline, week 104|SAS.|||Percentage of HbA1c||Standard Deviation|Mean
2623981|NCT01927861|Secondary|Change in IGF-I (Insulin-like Growth Factor-I)|Change from baseline (within 4 weeks prior to week 0) in IGF-I was evaluated after 104 weeks of treatment. Missing values were imputed using the LOCF method.|Baseline, week 104|SAS.|||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2623982|NCT01927861|Secondary|Incidence of Treatment Emergent Adverse Events|A treatment emergent adverse event (TEAE; for the pivotal phase) was defined as an event that had onset date on or after the date of visit 2 (week 0; start of treatment) and no later than the date of visit 12 (104 weeks; end of pivotal phase). For withdrawal participants (if any), an adverse event with onset date no later than 7 days after the last day of NN-220 treatment was included.|During 104 weeks of treatment|Safety analysis set (SAS) which included all participants who received at least one dose of trial product (NN-220, 0.033 mg/kg/day or NN-220, 0.066 mg/kg/day).|||Events|||Number
2623983|NCT01927861|Secondary|Height Velocity|Height velocity is change in height per year. The height velocity was calculated as the difference between current height (week 104) and height at week 52 divided by time between those measurement time points and multiplied by 365 days.|Week 52 to week 104|FAS.|||cm/year||Standard Deviation|Mean
2623984|NCT01927861|Secondary|Height Velocity|Height velocity is change in height per year. The height velocity was calculated as the difference between current height (week 52) and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days.|Baseline to week 52|FAS.|||Centimeters per year (cm/year)||Standard Deviation|Mean
2623985|NCT01927861|Secondary|Height Velocity SDS|Height velocity is change in height per year. The height velocity was calculated as the difference between current height (week 104) and height at week 52 divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using the formula: SDS = (height velocity - mean)/SD, where height velocity was the height velocity variable measured, mean and SD of height velocity by sex and age for the reference population. The scores were centered around zero. Positive SDS indicated greater height velocity and negative SDS indicated lesser height velocity than the mean of the reference population.|Week 52 to week 104|FAS.|||Standard deviation score||Standard Deviation|Mean
2623986|NCT01927861|Secondary|Height Velocity SDS|Height velocity is change in height per year. The height velocity was calculated as the difference between current height (week 52) and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using the formula: SDS = (height velocity - mean)/SD, where height velocity was the height velocity variable measured, mean and SD of height velocity by sex and age for the reference population. The scores were centered around zero. Positive SDS indicated greater height velocity and negative SDS indicated lesser height velocity than the mean of the reference population.|Baseline to week 52|FAS.|||Standard deviation score||Standard Deviation|Mean
2623987|NCT01927861|Primary|Change in Height SDS (Japanese National Reference Data)|Height SDS was calculated using the formula: SDS = (height - mean)/SD, where height was the height variable measured, mean and SD of height by sex and age for the reference population. The scores were centered around zero. Positive SDS indicated greater height and negative SDS indicated lesser height than the mean of the reference population. The change from baseline (week 0) in the height SDS after 104 weeks of treatment was analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline height SDS as a covariate. Positive value in change from baseline indicated that SDS was better than baseline SDS. Missing values were imputed using the last observation carried forward (LOCF) method.|Baseline, week 104|FAS.|||Standard deviation score||Standard Error|Least Squares Mean
2623988|NCT01927757|Secondary|Work Productivity and Activity Impairment (WPAI)|This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes.|Baseline, week 12 and week 24|"Full analysis set participants who were employed (for the first 3 scores); LOCF imputation was used. n indicates the number of participants included in each analysis."|||units on a scale||Standard Deviation|Mean
2623989|NCT01927757|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning.|Baseline and Week 24|Full analysis set; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2624260|NCT01924988|Primary|Number of Participants With Bladder or Rectal Injury|Bladder injury as detected by cystoscopy. Rectal injury detected by anoscopy.|Evaluated 1 week after procedure|1 patient failed to complete this follow-up.|||Participants|||Count of Participants
2623990|NCT01927757|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) at Week 12|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses of each domain, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning.|Baseline and Week 12|Full analysis set; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2623991|NCT01927757|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)|The HAQ-DI is a questionnaire on which participants are asked to rate their level of difficulty on daily activities (dressing and grooming, arising, eating, and walking) and personal abilities (hygiene, reach, grip, and activity) as well as their use of aids, devices, or help from another person for these activities and disabilities. Responses are scored from 0 indicating no difficulty to 3 indicating inability to perform a task in that area. The overall score is the average of each of the 8 category scores and ranges from 0 (no disability) to 3 (very severe, high-dependency disability).|Baseline and weeks 12 and 24|Full analysis set, last observation carried forward imputation (LOCF) was used.|||units on a scale||Standard Deviation|Mean
2623992|NCT01927757|Secondary|Percentage of Participants With DAS 28-CRP < 3.2|The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores less than 3.2 are considered low disease activity.|Weeks 12 and 24|Full analysis set, last observation carried forward imputation (LOCF) was used.|||percentage of participants||95% Confidence Interval|Number
2623993|NCT01927757|Secondary|Percentage of Participants With DAS28-CRP Improvement of ≥ 1.2 Units From Baseline|The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-reactive protein (CRP) level • Patient's global assessment of disease activity assessed on a score from 0 to 100. The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity.|Baseline and weeks 12 and 24|Full analysis set, last observation carried forward imputation (LOCF) was used.|||percentage of participants||95% Confidence Interval|Number
2623994|NCT01927757|Secondary|Change From Baseline in Disease Activity Score 28-C-Reactive Protein (DAS28-CRP)|"The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:~The number of swollen and tender joints assessed using the 28-joint count;~C-reactive protein (CRP) level~Patient's global assessment of disease activity assessed on a score from 0 to 100.~The DAS28-CRP score ranges from zero up to approximately ten. DAS28-CRP scores above 5.1 indicate high disease activity. A negative change from baseline indicates improvement."|Baseline and weeks 12 and 24|Full analysis set, last observation carried forward imputation (LOCF) was used.|||units on a scale||Standard Deviation|Mean
2623995|NCT01927757|Secondary|Percentage of Participants With an ACR 70 Response at Weeks 12 and 24|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in tender joint count; • ≥ 70% improvement in swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Weeks 12 and 24|Full analysis set with non-missing data|||percentage of participants||95% Confidence Interval|Number
2623996|NCT01927757|Secondary|Percentage of Participants With an ACR 50 Response at Weeks 12 and 24|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in tender joint count; • ≥ 50% improvement in swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Weeks 12 and 24|Full analysis set with non-missing data|||percentage of participants||95% Confidence Interval|Number
2623997|NCT01927757|Secondary|Percentage of Participants With an ACR 20 Response at Week 24|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Week 24|Full analysis set with non-missing data|||percentage of participants||95% Confidence Interval|Number
2623998|NCT01927757|Secondary|Percentage of Participants With an ACR 20 Response at Week 12 by Response Failure Type Subgroup|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Week 12|Full analysis set with non-missing data|||percentage of participants||95% Confidence Interval|Number
2623999|NCT01927757|Secondary|Percentage of Participants With an ACR 20 Response at Week 12 by Anti-adalimumab Antibody Subgroup|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Week 12|Full analysis set with non-missing data|||percentage of participants||95% Confidence Interval|Number
2624000|NCT01927757|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12|A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient Global Assessment of Joint Pain (measured on a 100 mm VAS); o Patient Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Physician Global Assessment of Disease Activity (measured on a horizontal scale from 0 to 100); o Health Assessment Questionnaire - Disability Index (HAQ-DI) scale from 0 to 3, where zero represents no disability and three very severe, high-dependency disability; o C-reactive protein level.|Baseline and Week 12|Full analysis set with non-missing data|||percentage of participants||95% Confidence Interval|Number
2624001|NCT01927718|Primary|Number of Participants With Response|Primary endpoint is response rate (RR) measured by the proportion of patients receiving the combination, whose disease stabilizes, or returns to at least its previous response level prior to progression, assessed at 3-months after starting the combination.1.Stringent Complete Remission (sCR): Follows criteria for CR, plus:Normal FLC ratio, Absence of clonal cells in the BM; Complete Remission (CR) All of the following criteria are met:Negative SIFE and UIFE:Disappearance of any soft tissue plasmacytomas:< 5% plasma cells in the BM. 2.Very Good Partial Response (VGPR):One or more of the following must be present:Serum and urine M-protein detectable by immunofixation but not on electrophoresis:≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours.Partial Response (PR) Both of the following must be present:≥ 50% reduction in SPEP:Reduction in 24-hour UPEP by ≥ 90% or to < 200 mg/24 hours.3.Stable Disease (SD)Does not meet the criteria for CR, VGPR, PR, or PD.4.Pr|3 months||||Participants|||Count of Participants
2624002|NCT01927627|Other Pre-specified|Impact of Enzalutamide on Circulating Tumor Cells (CTCs)|Quantify mRNA levels of Survivin in CTCs obtained from patients pre- and post-treatment with enzalutamide using the Veridex Cell Search Profile kit.|2 years|||||||
2624003|NCT01927627|Secondary|Safety of Enzalutamide|The number of patients that experience adverse events related to the study drug. NCI Cancer Clinical Trials Common Toxicity Criteria (version 4.0) will be utilized.|2 years|All participants that received treatment|||Participants|||Count of Participants
2624004|NCT01927627|Primary|To Evaluate the Clinical Efficacy of Enzalutamide|Clinical efficacy is measured as time to disease progression defined by biochemical recurrence (BCR). BCR was defined as PSA ≥0.2ng/mL on 2 consecutive lab results or any PSA rise that resulted in subsequent therapy.|2 years|All participants who received treatment and had biochemical recurrence.|||months||Full Range|Median
2624005|NCT01927575|Secondary|Radiation Reduction|To assess if a reduction in radiation dose can be achieved in the TOMO group as compared to imaging standards with equal or better injury detection rates from TOMO imaging.|Baseline Imaging Collection|||||||
2624006|NCT01927575|Primary|This Outcome Measure is Reporting the Number of Participants for Whom Hip, Wrist, or Tibia Injury Was Detected Using the TOMO as Well as Standard X-Ray and Standard CT|Clinical utility where the DTS could replace and/or complement existing imaging procedures; for example, Computed Tomography for fractures of the tibial plateau or scaphoid - where radiation dose, access to modality and cost play a factor in planning initial diagnosis and/or follow-up imaging strategies. Subsequent independent review by the principal investigator (PI) [or designee] to show the ability of the Fujifilm DTS system to provide images of clinical equivalence compared to those acquired on other FDA cleared imaging systems.|Baseline Imaging Collection|Three sets (1 - X-ray, 1- CT and 1 - Digital Tomosynthesis) of images of the tibia evaluated to confirm acceptable image quality and provided clinical and diagnostic value.|||participants|||Number
2624007|NCT01927562|Primary|Changed in Mixed Meal Tolerance From Baseline to 3 Months|Improvement in fasting plasma glucose based on Mixed Meal Tolerance Test between baseline and 3 months|3 months|The 5 subjects who did not receive an ablation were excluded from the efficacy population, yielding 52 subjects in the efficacy population (as-treated population).|||mg/dL||Standard Deviation|Mean
2624008|NCT01927419|Other Pre-specified|Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Select AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.|Day 1 of treatment to within 30 days past last dose|All participants who received at least 1 dose of study drug|||Participants|||Number
2624009|NCT01927419|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) Score|Health-related QOL was measured by mean changes from baseline in the EORTC-QLQ-C30 global health status/quality of life composite scale and by mean changes from baseline in the remaining EORTC QLQ-C30 questionnaire, Version 3. The EORTC QLQ-C30 is a questionnaire developed to assess the QOL of cancer patients. The questionnaire is a 30-item tool covering multiple items, including 5 functional scales (physical, role, emotional, social, and cognitive); 3 symptom scales (fatigue, nausea and vomiting, and pain); a global health status/QOL scale; and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Scores for each item range from 0 to 100. A high score for a functional scale represents a high (healthy) level of functioning, and a high score for the global health status represents a high QOL. However, a high score for a symptom scale represents more severe symptoms.|From Baseline to Week 25|All randomized participants. n=number of participants evaluable|||Units on a scale||Standard Deviation|Mean
2624010|NCT01927419|Secondary|Percentage of BRAF Mutation-positive Participants With Investigator-assessed Objective Response|Objective Response is is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR); percentage is determined by that total divided by the number of randomized patients. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Randomization to a minimum of 6 months|All BRAF mutation-positive participants|||Percentage of participants||95% Confidence Interval|Number
2624011|NCT01927419|Secondary|Investigator-assessed Progression-free Survival (PFS) in All Populations|PFS is defined as the time between the date of randomization and the first date of documented progression, as assessed by the investigator, or death due to any cause, whichever occurs first. WT=wild type|Date of randomization to disease progression or death, whichever occurs first, to approximately 10 months|All randomized participants|||Months||95% Confidence Interval|Median
2624012|NCT01927419|Secondary|Percentage of Participants With Investigator-assessed Objective Response in the Randomized Population|Objective Response Rate is is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) divided by the number of randomized patients. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Randomization to a minimum of 6 months|All randomized participants|||Percentage of participants||95% Confidence Interval|Number
2624013|NCT01927419|Primary|Percentage of Participants With Investigator-assessed Objective Response in the Randomized, BRAF Wild-type Population|Objective Response Rate is defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) divided by the number of randomized BRAF wild-type patients. CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm). PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Randomization to a minimum of 6 months|All randomized BRAF wild-type participants .|||Percentage of participants||95% Confidence Interval|Number
2624014|NCT01927120|Other Pre-specified|Rate of Natural Killer Cell (NK) Reconstitution|Investigators planned to monitor natural killer cell (NK) reconstitution. Standard immune deficiency flow cytometry panels (IDP) was to be drawn on days +90, +180, and +365 to evaluate NK reconstitution. Results of standard lab tests to be compared to compiled data at a later date|365 days post HCT|Lab test results to be compared to compiled data at a later date.||||||
2624015|NCT01927120|Other Pre-specified|Function of Blood Treg After Allogeneic HSCT|Percent of Treg suppression at day +30. Investigators had also planned to test Treg function at day +90, if sufficient Tregs had been available for analysis.|30 days post HCT|All evaluable participants at day +30.|||percentage of suppression||Standard Deviation|Median
2624016|NCT01927120|Secondary|STAT3, STAT5 (Y694), and S6 Phosphorylation Among Treg and Non-Treg at Day 90|Phosphorylation (p): pSTAT3, pSTAT5 (Y694), and pS6 among Treg and non-Treg at day +90.|90 days post HCT|All participants.|||percentage in total CD4s||Full Range|Median
2624017|NCT01927120|Secondary|STAT3, STAT5 (Y694), and S6 Phosphorylation Among Treg and Non-Treg at Day 30|Phosphorylation (p): pSTAT3, pSTAT5 (Y694), and pS6 among Treg and non-Treg at day +30.|30 days post HCT|All participants.|||percentage in total CD4s||Full Range|Median
2624018|NCT01927120|Secondary|Proportion of Treg Among Blood CD4+ T Cells at Day +90 After HCT|The proportion of Tregs to non-Treg CD4+ cells to be assessed at day +90. Natural Killer Cells (NKs): Median K/uL NK cells.|90 days post HCT|All participants.|||K/uL NK cells||Full Range|Median
2624019|NCT01927120|Secondary|Incidence of Unexpected or Serious Adverse Events (AEs)|Grade 3-5 unexpected or serious adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.03) were captured up to day +130 or 30 days after the last dose of IL-2. Events listed, with causality in relation to study treatment noted.|Up to days 130 post HCT|All participants.|||adverse events|||Number
2624020|NCT01927120|Secondary|Incidence of Non-relapse Death|Incidence of Non-relapse death/Transplant-related mortality. Non-relapse death is defined as death in continuous remission from primary disease requiring transplantation.|365 days post HCT|All participants.|||percentage of participants||95% Confidence Interval|Number
2624021|NCT01927120|Secondary|Cumulative Incidence of Chronic GVHD by Day +365|Cumulative incidence of chronic GVHD by day +365 per NIH Consensus criteria.|365 days post HCT|All participants.|||percentage of participants||95% Confidence Interval|Number
2624022|NCT01927120|Secondary|Cumulative Incidence of Grade II-IV Acute GVHD by Day +100|Acute GVHD will be graded per the 1995 consensus guidelines.|100 days post HCT|All participants.|||percentage of participants||95% Confidence Interval|Number
2624023|NCT01927120|Secondary|Cumulative Incidence of Relapse|Incidence of primary disease relapse per standard definitions.|1 year post HCT|All participants.|||percentage of participants||95% Confidence Interval|Number
2624024|NCT01927120|Secondary|Overall Survival at Day +365|Overall survival will be defined as the time from transplant date to death from any cause.|365 days post HCT|All participants.|||percentage of participants||95% Confidence Interval|Number
2624025|NCT01927120|Primary|Regulatory T Cells (Tregs)/Total CD4+ Cells at Day 30 Post-HCT|Percentage of Treg among blood CD4+ T cells at day 30 after hematopoietic cell transplantation (HCT), to compare to SIR/TAC alone data from a previous trial (median of 16%). The study was designed to capture an increase in regulatory T cells from a median of 16.0% at day +30.|30 days post HCT|All participants.|||percentage of CD4+Tregs||Full Range|Median
2624026|NCT01927055|Primary|Change in Dizziness/ Lightheadedness/ Feeling Faint/ or Feeling Like You Might Blackout (OHSA Item 1)|OHSA item 1 scale range: 0 (none) -10 (worst), likert scale. Change: score at end of study minus score at randomization. A positive score indicates worsening during the double-blind randomized phase relative to value at randomization, while a negative score indicates an improvement in symptom severity.|Change from Randomization to Week 1|"Patients entering the double-blind, randomized phase and having a visit at week 1 of the double-blind phase were analyzed.~Study was stopped when only 5% of planned participants had completed the study to prevent competition with FDA mandated post-marketing requirement study."|||units on a scale||Standard Deviation|Mean
2624027|NCT01926977|Secondary|Patients With Post Injection Pain Score of One or Higher on Pain Scale|Pain score rated on an 11 point numerical rating from 0-10 ( 0 = no pain, and 10 = worst possible pain) administered to each patient verbally at visit #1 and visit #2. The data below shows number of patients with pain score 1 or greater in each group.|24 to 48 hours (visit #1) and 5 to 7 days (visit #2)||||participants|||Number
2624028|NCT01926977|Primary|Evidence of Anterior Chamber Inflammation|Evidence of anterior chamber inflammation at visit #1 and #2 using Standardization of Uveitis Nomenclature (SUN)|24 to 48 hours (visit #1) and 5 to 7 days (visit #2)||||participants|||Number
2624029|NCT01926886|Secondary|Disease-Free Survival (DFS) as Assessed by Routine Clinical, Radiological and Laboratory Criteria|DFS was defined as time from first study drug administration (i.e. Day 1 of Cycle 7) to local, regional or distant recurrence, contralateral breast cancer or death from any cause (whichever occurred first). Diagnosis of breast cancer relapse was made based on routine clinical, radiological and laboratory criteria. Acceptable methods of confirmation of recurrence included radiology, computerized tomography (CT) scan, brain scan, ultrasound, or cytology, as per local practice. In case of uncertainly, disease relapse was to be confirmed by histological or cytological examination of a suspicious lesion, if possible.|From start of treatment up to 45 months|ITT population|||months||95% Confidence Interval|Median
2624030|NCT01926886|Secondary|Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1)|HCPEX-1 questionnaire is used to assess health care professional's overall satisfaction and perceived time savings with trastuzumab SC vial in the hospital. The HCPEX-1 questionnaire (19 questions) was completed by the health care professionals administering the trastuzumab IV and SC in the hospital after at least 3 participants had completed the in-hospital part of the study.|Prior (0 hours) to Cycle 12 (cycle length=21 days)|Health care professionals who participated in the study and completed the HCPEX-1 questionnaire.|||Health care professionals|||Number
2624031|NCT01926886|Secondary|Number of Participants With Modalities Assessed Using PEX - Part 2: At Home|PEX - Part 2 questionnaire contains 6 items to assess the participant's experience on the use of trastuzumab SC vials at home.Participants answered the following questions: 1. Did the nursing staff ever have any difficulty giving the trastuzumab injection SC? 2. How many minutes did the injection (it) usually take? 3. How painful was this usually? 4. How long did the SC sessions usually last from arrival until departure of the nurse? 5. How anxious did having the SC treatment make you feel? 6. In general how would you describe these SC treatment sessions at home?|1 month after end of treatment (up to 10 months)|ITT population|||participants|||Number
2624032|NCT01926886|Secondary|Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital|PEX-Part 1 questionnaire contains 25 items to assess participant's experience on use of trastuzumab at hospital.1.Place of treatment? 2.Was it same place as for chemotherapy? 3.How long did it take to travel there? 4.How easy was travel? 5.Company required for travelling? 6.Was travelling cost a problem? 7.Considering all these,was travelling for treatment overall a problem? 8.How helpful were nursing/medical staff? 9.How pleasant was place of study? 10.How was IV treatment given? 11.If Venous Access Device(VAD),what was it? 12.Did hospital staff have difficulty inserting cannula? 13.Time for cannulation? 14.How painful was IV? 15.How much time to access port/line usually take? 16.How painful was it? 17.Time for IV sessions? 18.Anxiety level while IV treatment? 19.How would you describe IV sessions? 20.Did hospital staff have difficulty giving SC? 21.Time for SC? 22.How painful was SC? 23.Time for SC sessions? 24.Anxiety level while SC treatment? 25.How would you describe SC sessions?|Prior (0 hours) to Cycle 12 (cycle length=21 days)|ITT population|||participants|||Number
2624033|NCT01926886|Secondary|Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire|"MDASI questionnaire is used to rate the interference of symptoms. The measure includes 6 symptom interference items which ask how much all symptoms, interfere with domains (general activity, mood, work, relations with others, walking, and enjoyment of life). Each items were rated on a 0-10 scale (0 = did not interfere; 10 = interfered completely). Lower scores indicating better outcome. Total score was summed and ranged from 0 to 50, with lower scores indicating better outcome."|Prior (0 hours) to Cycles 7, 10, 13, 16 (Each cycle=21 days)|ITT population. Here, “number of participants analysed” included participants who were evaluable for the outcome measure and “n” included participants who were evaluable for the specified category.|||units on a scale||Standard Deviation|Mean
2624034|NCT01926886|Secondary|Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire|"MDASI questionnaire is used to rate the severity of 13 core items (pain, fatigue, nausea, vomiting, disturbed sleep, distress, shortness of breath, memory difficulties, lack of appetite, drowsiness, dry mouth, sadness, numbness or tingling). Participants were asked to rate the severity of each symptom at its worst using 0-10 numerical rating scales with 0 = not present and 10 = as bad as you can imagine. Total score was summed and ranged from 0 to 130, with lower scores indicating better outcome."|Prior (0 hours) to Cycles 7, 10, 13, 16 (Each cycle=21 days)|ITT population. Here, “number of participants analysed” included participants who were evaluable for the outcome measure and “n” included participants who were evaluable for the specified category.|||units on a scale||Standard Deviation|Mean
2624035|NCT01926886|Secondary|Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home|"PSQ2 is a quality of care questionnaire containing 13 questions each of Sections A and B, with a total of 26 questions categorized on the opinion of participants about the clinicians, opinion of participant about the other staff and other questions. Responses to questions with section A were categorized to Not at all, To a small extent, to a moderate extent, to a large extent, to a very large extent, Not applicable and missing. Responses to questions with section B were categorized to Not important, a little important, important, very important, of utmost importance, not applicable and missing. Participant experience with the treatment provided during the at-home part of the study was evaluated with the PSQ2 questionnaire completed by the participant prior to the fifth dose of trastuzumab SC at home."|Prior (0 hour) to fifth trastuzumab SC administration at Cycle 17 (cycle length=21 days)|ITT population. Here, “number of participants analysed” included participants who were evaluable for the outcome measure.|||participants|||Number
2624120|NCT01926028|Secondary|Number of Patients Who Were Recurrence-free Over the 12-month Post-vaccination Period|Number of patients with documented RVVC who were recurrence-free over the 12-month post-vaccination period in the NDV-3A vaccine group and the placebo group|12 months|All participants|||Participants|||Count of Participants
2624036|NCT01926886|Secondary|Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital|"PSQ1 is a quality of care questionnaire containing 14 questions each of Sections A and B, with a total of 28 questions categorized on the opinion of participants about the clinicians, opinion of participants about the other staff and other questions. Responses to questions with section A (except question 11) were categorized to not at all, to a small extent, to a moderate extent, to a large extent, to a very large extent, Not applicable and missing. Responses to questions with section B were categorized to Not important, a little important, important, very important, of utmost importance, not applicable and missing. Responses to question 11 with section A were categorized to Yes, but not long, yes, quite long, yes, much long and missing. Participant experience with the treatment provided during the in-hospital part of the study was evaluated with PSQ1 questionnaire completed by the participant prior to the first dose of trastuzumab SC at home."|Prior (0 hour) to first trastuzumab SC administration at Cycle 13 (cycle length =21 days)|ITT population. Here, “number of participants analysed” included participants who were evaluable for the outcome measure.|||participants|||Number
2624037|NCT01926886|Primary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non- serious AEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An emergent AE was defined as occurring within 35 days after last treatment administration.|Up to 45 months|Safety Population included all enrolled participants who received at least one dose of study medication.|||percentage of participants|||Number
2624038|NCT01926782|Secondary|Percent Change From Baseline in Apo A1 in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Apo A1 ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Apo A1 ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624039|NCT01926782|Secondary|Percent Change From Baseline in Apo A1 in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Apo A1 ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Apo A1 ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624040|NCT01926782|Secondary|Percent Change From Baseline in Apo A1 in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (subjects with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Apo A1 ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624041|NCT01926782|Secondary|Percent Change From Baseline in Apo A1 in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (subjects with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Apo A1 ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624042|NCT01926782|Secondary|Percent Change From Baseline in Fasting Triglycerides in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Mean
2624043|NCT01926782|Secondary|Percent Change From Baseline in Fasting Triglycerides in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Mean
2624115|NCT01926028|Secondary|Cervicovaginal Wash Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period|Cervicovaginal wash anti-Als3 IgG titers will be measured by ELISA at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.|0, 14, 28, 90, 180 and 360 days|All participants|||Titer (dilution^-1)||Standard Deviation|Geometric Mean
2624044|NCT01926782|Secondary|Percent Change From Baseline in Fasting Triglycerides in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Mean
2624045|NCT01926782|Secondary|Percent Change From Baseline in Fasting Triglycerides in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Mean
2624046|NCT01926782|Secondary|Percent Change From Baseline in HDL-C in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. HDL-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|HDL-C ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624047|NCT01926782|Secondary|Percent Change From Baseline in HDL-C in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. HDL-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|HDL-C ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624048|NCT01926782|Secondary|Percent Change From Baseline in HDL-C in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm|From Baseline to Week 24|HDL-C ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624049|NCT01926782|Secondary|Percent Change From Baseline in HDL-C in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|HDL-C ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624050|NCT01926782|Secondary|Percent Change From Baseline in Lipoprotein (a) in Participants Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Mean
2624051|NCT01926782|Secondary|Percent Change From Baseline in Lipoprotein (a) in Participants Not Receiving Concomitant Statin Therapy at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Mean
2624052|NCT01926782|Secondary|Percent Change From Baseline in Lipoprotein (a) in Participants Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment were included in the imputation model. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Mean
2624053|NCT01926782|Secondary|Percent Change From Baseline in Lipoprotein (a) in Participants Not Receiving Concomitant Statin Therapy at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on-or off-treatment were included in the imputation model. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Mean
2624054|NCT01926782|Secondary|Percentage of Participants (With Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection). mITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|Up to Week 24|mITT population (participants with concomitant statin therapy)|||percentage of participants|||Number
2624055|NCT01926782|Secondary|Percentage of Participants (Without Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 24 (i.e. up to 21 days after last injection). mITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|Up to Week 24|mITT population (participants without concomitant statin therapy)|||percentage of participants|||Number
2624056|NCT01926782|Secondary|Percentage of Participants (With Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|Up to Week 24|ITT population (participants with concomitant statin therapy)|||percentage of participants|||Number
2624057|NCT01926782|Secondary|Percentage of Participants (Without Concomitant Statin Therapy) Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|Up to Week 24|ITT population (participants without concomitant statin therapy)|||percentage of participants|||Number
2624058|NCT01926782|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL(1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL(2.59 mmol/L) (With Concomitant Statin Therapy) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection). mITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|Up to Week 24|mITT population (participants with concomitant statin therapy)|||percentage of participants|||Number
2624059|NCT01926782|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C<70 mg/dL (1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C<100 mg/dL(2.59 mmol/L) (Without Concomitant Statin Therapy) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection). mITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|Up to Week 24|mITT population (participants without concomitant statin therapy)|||percentage of participants|||Number
2624060|NCT01926782|Secondary|Percentage of Very High Cardiovascular (CV) Risk Participants Reaching Calculated LDL-C <70 mg/dL or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (With Concomitant Statin Therapy) at Week 24 - ITT Analysis|Very high CV risk: history of documented coronary heart disease (CHD) or CHD risk equivalent. High CV risk: calculated 10-year fatal CVD risk score ≥5%, moderate chronic kidney disease, type 1/type 2 diabetes mellitus (DM) without target organ damage, or heFH not meeting definition of very high risk. Moderate CV risk: calculated 10-year fatal CVD risk score ≥1 &<5%. CHD risk equivalent: peripheral arterial disease, ischemic stroke, transient ischemic attack, abdominal aortic aneurysm, carotid artery(CA)occlusion>50%, carotid endarterectomy/CA stent procedure, renal artery stenosis/stent procedure, type 1/type 2 DM with target organ damage. Adjusted percentages at Week 24 obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment included in imputation model. ITT population (subjects with or without concomitant statin therapy).|Up to Week 24|ITT population (participants with concomitant statin therapy)|||percentage of participants|||Number
2624116|NCT01926028|Secondary|Serum Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period|Serum anti-Als3 IgA1 titers will be measured by ELISA at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.|0, 14, 28, 90, 180 and 360 days|All participants|||Titer (dilution^-1)||Standard Deviation|Geometric Mean
2624061|NCT01926782|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C<70 mg/dL or Moderate or High CV Risk Participants Reaching Calculated LDL-C<100 mg/dL (Without Concomitant Statin Therapy) at Week 24 - ITT Analysis|Very high CV risk: history of documented coronary heart disease (CHD) or CHD risk equivalent. High CV risk: calculated 10-year fatal CVD risk score ≥5%, moderate chronic kidney disease, type 1/type 2 diabetes mellitus (DM) without target organ damage, or heFH not meeting definition of very high risk. Moderate CV risk: calculated 10-year fatal CVD risk score ≥1 &<5%. CHD risk equivalent: peripheral arterial disease, ischemic stroke, transient ischemic attack, abdominal aortic aneurysm, carotid artery(CA)occlusion>50%, carotid endarterectomy/CA stent procedure, renal artery stenosis/stent procedure, type 1/type 2 DM with target organ damage. Adjusted percentages at Week 24 obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment included in imputation model. ITT population (subjects with or without concomitant statin therapy).|Up to Week 24|ITT population (participants without concomitant statin therapy)|||percentage of participants|||Number
2624062|NCT01926782|Secondary|Percent Change From Baseline in Total-C at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Total-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Total-C ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624063|NCT01926782|Secondary|Percent Change From Baseline in Total-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Total-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Total-C ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624064|NCT01926782|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Non-HDL-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Non-HDL-C ITT population (participants with concomitant statin therapy).|||percent change||Standard Error|Least Squares Mean
2624065|NCT01926782|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Non-HDL-C ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Non-HDL-C ITT population (participants without concomitant statin therapy).|||percent change||Standard Error|Least Squares Mean
2624066|NCT01926782|Secondary|Percent Change From Baseline in Apo B at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Apo B ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Apo B ITT population (participants with concomitant statin therapy).|||percent change||Standard Error|Least Squares Mean
2624067|NCT01926782|Secondary|Percent Change From Baseline in Apo B at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Apo B ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|Apo B ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624068|NCT01926782|Secondary|Percent Change From Baseline in Total-C at Week 24 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Total-C ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624098|NCT01926444|Secondary|Endoscopist's Perception of Colonoscopy- Amount of Colonic Spasm on Insertion and Withdrawal|Endoscopist's perception of the amount of colonic spasm on insertion and withdrawal measured on five-point Likert scale according to the following: Strongly Agree, Agree, Agree nor Disagree, Disagree, Strongly Disagree|From the time of introduction of the colonoscope, to removal of colonoscope. Range of duration of colonoscopy 5.00- 50.10 minutes.|FAS (randomized patients who received at least one dose of study drug, had a baseline and at least one post-baseline VAS rating; N=262)|||Participants|||Count of Participants
2624069|NCT01926782|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Total-C ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624070|NCT01926782|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 in Participants Receiving Concomitant Statin Therapy - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection). Subjects of the mITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Non-HDL-C mITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624071|NCT01926782|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 in Participants Not Receiving Concomitant Statin Therapy - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection). Subjects of the mITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Non-HDL-C mITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624072|NCT01926782|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Non-HDL-C ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624073|NCT01926782|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Non-HDL-C ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624074|NCT01926782|Secondary|Percent Change From Baseline in Apo B at Week 24 in Participants Receiving Concomitant Statin Therapy - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Apo B mITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624075|NCT01926782|Secondary|Percent Change From Baseline in Apo B at Week 24 in Participants Not Receiving Concomitant Statin Therapy - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Apo B mITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624076|NCT01926782|Secondary|Percent Change From Baseline in Apo B at Week 24 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Apo B ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624117|NCT01926028|Secondary|Serum Anti-Als3 IgG Titers Over the 12-month Post-vaccination Period|Serum anti-Als3 IgG titers will be measured by ELISA at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.|0, 14, 28, 90, 180 and 360 days||||Titer (dilution^-1)||Standard Deviation|Geometric Mean
2624077|NCT01926782|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. Subjects of the ITT population (with or without concomitant statin therapy) with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Apo B ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624078|NCT01926782|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Receiving Concomitant Statin Therapy - On-treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|mITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624079|NCT01926782|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - On-treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|mITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624080|NCT01926782|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|ITT population (participants with concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624081|NCT01926782|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. ITT population (subjects with or without concomitant statin therapy). Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 12|ITT population (participants without concomitant statin therapy)|||percent change||Standard Error|Least Squares Mean
2624082|NCT01926782|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 in Participants Receiving Concomitant Statin Therapy - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis). Modified ITT (mITT) population (subjects with or without concomitant statin therapy): all randomized and treated subjects who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on-treatment. Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|mITT population|||percent change||Standard Error|Least Squares Mean
2624083|NCT01926782|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 in Participants Not Receiving Concomitant Statin Therapy - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection) (on-treatment analysis). Modified ITT (mITT) population (subjects with or without concomitant statin therapy): all randomized and treated subjects who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on-treatment. Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|Modified ITT (mITT) population (participants without concomitant statin therapy): all randomized and treated participants who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2624084|NCT01926782|Primary|Percent Change From Baseline in Calculated LDL-C in Participants Receiving Concomitant Statin Therapy - Intent-to-Treat (ITT Analysis)|Adjusted least squares (LS) means and standard errors at Week 24 and at averaged Week 21 to 24 were obtained from a mixed effect model with repeated measures (MMRM) model to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in this model (ITT analysis). ITT population (subjects with concomitant statin therapy): all randomized subjects who received concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment. Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|ITT population (participants with concomitant statin therapy): all randomized participants who received concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2624085|NCT01926782|Primary|Percent Change From Baseline in Calculated LDL-C in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis|Adjusted LS means and standard errors at Week 24 and at averaged Week 21 to 24 from MMRM including available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment. ITT population (subjects without concomitant statin therapy): all randomized subjects who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment. Alirocumab 75 mg Q2W arm (calibrator arm) was included only to facilitate comparison of results of this study with the results of other studies that used an alirocumab 75 mg Q2W regimen. Hence no statistical comparison was performed for this arm.|From Baseline to Week 24|ITT population (participants without concomitant statin therapy): all randomized participants who did not receive concomitant statin therapy, with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2624086|NCT01926626|Other Pre-specified|Tolerability of Moclobemide + Nicotine Patch|Tolerability of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants requiring dose reductions (or discontinuation of medication).|1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch|Participants who received Moclobemide.|||participants|||Number
2624087|NCT01926626|Secondary|Percentage of Change in Expired Air Carbon Monoxide (CO) During the First Week of Nicotine Patch Treatment.|The initial response to nicotine patch will be assessed by looking at the percent change in expired air carbon monoxide (CO) at the end of week one (Study Visit 2) relative to baseline (Study Visit 1).|Baseline and 1 week|Participants who received Moclobemide.|||percentage of change||Standard Error|Mean
2624088|NCT01926626|Other Pre-specified|Safety of Moclobemide + Nicotine Patch|"Safety of the moclobemide + nicotine patch treatment will be assessed by tabulating the number of participants rating side effects > moderate."|1, 2, 4, 7 and 11 weeks after starting Moclobemide + Nicotine Patch|Participants who received Moclobemide.|||participants|||Number
2624089|NCT01926626|Secondary|Percentage of Change in Smoking Withdrawal Symptoms|Withdrawal symptoms will be assessed by questionnaire on Quit Day, 1 week post quit, 3 weeks post quit, 6 weeks post quit,10 weeks post quit and 6 months post quit (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.|Quit day and 1 week, 3 weeks, 6 weeks, 10 weeks and 6 months post quit day||||percentage of change||Standard Error|Mean
2624090|NCT01926626|Secondary|Continuous Ten Week Abstinence From Smoking|Number of participants who reported continuous ten-week abstinence from smoking (weeks 1-10 post quit day), confirmed by expired air CO.|10 weeks post quit day||||participants|||Number
2624091|NCT01926626|Secondary|Point Abstinence From Smoking at Six Months Post Quit|Number of participants who reported 7-day point abstinence from smoking at six months post quit, confirmed by expired air CO.|7 day point abstinence from smoking at six months post quit||||participants|||Number
2624092|NCT01926626|Primary|Continuous Four-week Abstinence From Smoking|Number of participants who reported continuous four-week abstinence from smoking (weeks 6-10 post target quit date), confirmed by expired air carbon monoxide (CO).|Weeks 6-10 post quit day||||participants|||Number
2624093|NCT01926509|Primary|Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event|An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The number of participants who had study drug discontinued due to an AE was summarized.|Up to 28 days|All participants who received at least one dose of the investigational drug|||Participants|||Number
2624094|NCT01926509|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The number of participants that reported at least 1 AE was summarized.|Up to 42 days|All participants who received at least one dose of the investigational drug|||Participants|||Number
2624095|NCT01926509|Primary|Area Under the Concentration Time-curve From Hour 0 to 24 Hours (AUC0-24hr) of MK-8892 at Day 1 and Day 28|Blood samples taken at Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24 hours postdose on Days 1 and 28 to determine the AUC0-24hr.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose on Days 1 and 28|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model and have data available for endpoint.|||μM*hr||95% Confidence Interval|Geometric Mean
2624096|NCT01926444|Secondary|Subject Satisfaction and Acceptability of the Colonic Analgesia - Patient's Global Impression of Abdominal Pain|Subject satisfaction and acceptability of the colonic analgesia modality offered by GIC-1001 was assessed with the Patient Global Impression of Abdominal Pain (P.G.I.A.P.) (1 question), asking patients to rate their pain during the procedure according to a 5-point Likert scale: Absent, Mild, Moderate, Severe, Intolerable. The P.G.I.A.P was administered after the colonoscopy during subject recovery.|Post-colonoscopy- during subject recovery|FAS (randomized patients who received at least one dose of study drug, had a baseline and at least one post-baseline VAS rating; N=262)|||Participants|||Count of Participants
2624097|NCT01926444|Secondary|Patient's Willingness to Repeat Experience|Patients' willingness for repeat colonoscopy, was assessed with the Patient Willingness to Repeat Experience (P.W.R.E.) questionnaire (1 question), asking patients to rate their willingness to repeat the procedure according to a 5-point Likert scale: Strongly Agree, Agree, Agree nor Disagree, Disagree, Strongly Disagree. The P.W.R.E was administered after the colonoscopy during subject recovery.|Post-colonoscopy- during subject recovery|FAS (randomized patients who received at least one dose of study drug, had a baseline and at least one post-baseline VAS rating; N=262)|||Participants|||Count of Participants
2624099|NCT01926444|Secondary|Endoscopist's Perception of Colonoscopy- Adequacy of Analgesia, Difficulty of Insertion and Withdrawal|Endoscopist's perception of the adequacy of analgesia, difficulty of insertion and withdrawal measured on a five-point Likert scale: Strongly Agree, Agree, Agree nor Disagree, Disagree, Strongly Disagree|From the time of introduction of the colonoscope, to removal of colonoscope. Range of duration of colonoscopy 5.00- 50.10 minutes.|FAS (randomized patients who received at least one dose of study drug, had a baseline and at least one post-baseline VAS rating; N=262)|||Participants|||Count of Participants
2624100|NCT01926444|Secondary|Total Examination Time (Colonoscopy)|Defined as the time from endoscope insertion to complete removal of the endoscope; measured in minutes|From the time of introduction of the colonoscope, to removal of colonoscope. Range of duration of colonoscopy 5.00- 50.10 minutes.|FAS (randomized patients who received at least one dose of study drug, had a baseline and at least one post-baseline VAS rating; N=262)|||minutes||Standard Deviation|Mean
2624101|NCT01926444|Secondary|Safety-Plasma Concentrations of Trimebutine and N-Desmethyl-Trimebutine|A pharmacokinetic (PK) analysis was carried out on the first 24 patients randomized, equally distributed between treatment groups; 18 patients were assigned to active treatment|Day 4 prior to colonoscopy.|Trimebutine and N-Desmethyl-Trimebutine plasma concentrations were assessed in all arms, with the exception of placebo|||ng/mL||Standard Deviation|Mean
2624102|NCT01926444|Secondary|Colonoscopy Completion Rate (%)|Qualitative outcome: colonoscopy completion is defined as a procedure performed entirely, from initial anal insertion, reaching of caecum, and complete removal of the scope. Completion rate is then the number of patient (%) with a complete colonoscopy (up to the caecum) divided by the number of trial participants.|Number of patients during trial with a complete colonoscopy, where the scope has reached the caecum during the colonoscopy. Range of duration of colonoscopy 5.00- 50.10 minutes.|FAS (randomized patients who received at least one dose of study drug, had a baseline and at least one post-baseline VAS rating; N=262)|||Participants|||Count of Participants
2624103|NCT01926444|Secondary|Time to Caecum|Time to Caecum is the time taken by the physician to reach the caecum with the colonoscope, from the insertion in the anus. Time to Caecum was measured during colonoscopy, for which total duration of colonoscopy ranged between a minimum of 5.00 and a maximum of 50.10 minutes.|From the time of introduction of the colonoscope, to removal of colonoscope. Range of duration of colonoscopy 5.00- 50.10 minutes.|FAS (randomized patients who received at least one dose of study drug, had a baseline and at least one post-baseline VAS rating; N=262)|||minutes||Standard Deviation|Mean
2624104|NCT01926444|Primary|Measurements of Visceral Pain, Using a 100-mm Visual Analog Scale (VAS)|The Primary Outcomes Measure was the pain VAS 100-mm AUC (0mm = no pain; 100mm = worst pain), constructed from serial pain VAS measurements performed during colonoscopy. At least 8 pain VAS measurements were made, and the length of the colonoscope inserted (or removed on the way out) was recorded at every measurement. The X-axis of the VAS versus anatomical locations was defined accordingly: each VAS value corresponded to a relative length of inserted colonoscope (d/2Lc) of the X axis, where d was the actual length of the inserted colonoscope and 2Lc represented twice the total length of the colon examined (Lc). Before scope insertion the X value equaled zero. Once the caecum was reached, the X value was 0.5. Upon complete removal of the endoscope, the X value was 1. This allowed standardization of colonic length between study subjects. Visceral pain AUC (mm) was calculated from all serial measurements, where the length of inserted colonoscope determined the VAS measurement's location|Assessed at different anatomical locations: (1) before colonoscopy, (2) insertion of scope in anus, (3) at rectosigmoid flexure, (4) at splenic flexure, (5) at hepatic flexure, (6) at caecum, (7) at splenic flexure on way back, (8) after colonoscopy.|Primary endpoint assessed in the FAS (randomized patients who received at least one dose of study drug, had a baseline and at least one post-baseline VAS rating; N=262) and PP analysis sets (randomized patients in the FA population with ≥80% treatment compliance, who had at least 6/8 VAS ratings and no major protocol deviations; N=213)|||mm||Standard Deviation|Mean
2624105|NCT01926119|Secondary|Change in Motor Strength and Joint Range of Motion||End of each of the 5 treatment sessions and at 1-week follow-up relative to baseline|This data was not collected and therefore not analyzed.||||||
2624106|NCT01926119|Secondary|Trophic Changes||End of each treatment session and at 1-week follow-up as compared to baseline|This data was not collected and therefore not analyzed.||||||
2624107|NCT01926119|Secondary|Change in Sudomotor Function||End of each treatment session and at 1-week follow-up as compared to baseline|This data was not collected and therefore not analyzed.||||||
2624108|NCT01926119|Secondary|Change in Vasomotor Function||End of each treatment session and at 1-week follow-up as compared to baseline|This data was not collected and therefore not analyzed.||||||
2624109|NCT01926119|Secondary|Change in Sensory Perception||End of each treatment session and at 1-week follow-up as compared to baseline|This data was not collected and therefore not analyzed.||||||
2624110|NCT01926119|Secondary|Change in Motor Function and Coordination|As assessed by functional capacity exam and physical exam|End of 5-day treatment series and at 1-week follow-up relative to baseline|This data was not collected and was therefore not analyzed.||||||
2624111|NCT01926119|Primary|Change in Pain|Numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable|Baseline to post-TMS day 5|Completed 5 days of TMS|||units on a scale||Full Range|Mean
2624112|NCT01926028|Secondary|Als3-specific T-cell Production of Interleukin-17A Over the Post-vaccination Period|Als3-specific T-cell production of interleukin-17A will be measured by enzyme-linked immunospot (ELISpot) at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.|0, 14, 90 days|All Participants|||Spot Forming Units||Standard Deviation|Geometric Mean
2624113|NCT01926028|Secondary|Als3-specific T-cell Production of Interferon Gamma Over the Post-vaccination Period|Als3-specific T-cell production of interferon gamma will be measured by enzyme-linked immunospot (ELISpot) at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.|0, 14, 90 days|All participants|||Spot Forming Units||Standard Deviation|Geometric Mean
2624114|NCT01926028|Secondary|Cervicovaginal Wash Anti-Als3 IgA1 Titers Over the 12-month Post-vaccination Period|Cervicovaginal wash anti-Als3 IgA1 titers will be measured by ELISA at pre-defined time points over the 12-month post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.|0, 14, 28, 90, 180 and 360 days|All participants|||Titer (dilution^-1)||Standard Deviation|Geometric Mean
2624121|NCT01926028|Secondary|Number of Patients <40 Years Old Who Were Recurrence-free Over the 12-month Post-vaccination Period|Number of patients <40 years old with documented RVVC who were recurrence-free over the 12-month post-vaccination period in the NDV-3A vaccine group and the placebo group|12 months|Participants <40 years old|||Participants|||Count of Participants
2624122|NCT01926028|Primary|Summary of Injection Site Reactions for the Safety Population Over the 12-months Post Vaccination Period|Summary of injection site reactions for the safety population over the 12-months post-vaccination period in the NDV-3A vaccine group, the NDV-3 vaccine group, and the placebo group.|12-month|All enrolled patients.|||AEs|AEs||Count of Units
2624123|NCT01926015|Secondary|Geometric Mean Titers for Poliovirus Type 3 Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers.|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint|||NA Titer||95% Confidence Interval|Geometric Mean
2624124|NCT01926015|Secondary|Geometric Mean Titers for Poliovirus Type 2 Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers.|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint|||NA Titer||95% Confidence Interval|Geometric Mean
2624125|NCT01926015|Secondary|Geometric Mean Titers for Poliovirus Type 1 Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV. Poliovirus antibodies are expressed as neutralizing antibody (NA) titers.|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint|||NA Titer||95% Confidence Interval|Geometric Mean
2624126|NCT01926015|Secondary|Geometric Mean Titers for Pertussis FHA Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint|||EU/mL||95% Confidence Interval|Geometric Mean
2624127|NCT01926015|Secondary|Geometric Mean Titers for Pertussis Toxin Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint|||EU/mL||95% Confidence Interval|Geometric Mean
2624128|NCT01926015|Secondary|Geometric Mean Titers for Tetanus Toxin Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint|||IU/mL||95% Confidence Interval|Geometric Mean
2624129|NCT01926015|Secondary|Geometric Mean Titers for Diphtheria Toxin Antibody|Participant serum was collected for determination of antibody responses before the first dose of study vaccine (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|Predose (Baseline) and 4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint|||IU/mL||95% Confidence Interval|Geometric Mean
2624130|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event of Special Interest: Injection-site Adverse Events|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.|Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Participants are counted only once within a study Period and only once Overall.|||Percentage of participants|||Number
2624131|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event of Special Interest: Vomiting|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.|Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Participants are counted only once within a study Period and only once Overall.|||Percentage of participants|||Number
2624184|NCT01925417|Secondary|Quality of Life (SF-36)|"Quality of Life (SF-36) will be assessed by comparing the subject's baseline quality of life score to his/her scores obtained at the 7-, 30- and 60-day follow-up visits.~The scale is from 0-100, with higher scores meaning better outcomes."|60 days||||score on a scale||Standard Deviation|Mean
2624132|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event of Special Interest: Diarrhea|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.|Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Participants are counted only once within a study Period and only once Overall.|||Percentage of participants|||Number
2624133|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event of Special Interest: Fever|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events of special interest included fever, diarrhea, vomiting, and injection-site adverse events.|Period 1 (up to 14 days after Visit 1 [V1] or V2), Period 2 (up to 14 days after V3 or V4), Period 3 (up to 14 days after V5 or V6), and Overall (up to 14 days after any visit)|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Each participant was counted only once within a study Period and only once Overall.|||Percentage of participants|||Number
2624134|NCT01926015|Secondary|Percentage of Participants Reporting an Adverse Event With Incidence >=1%|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered study drug and which does not necessarily have to have a causal relationship with this treatment. Any worsening of a preexisting condition that is temporally associated with the use of the study drug is also an adverse event. Adverse events with an incidence >=1% in either treatment group were recorded.|Up to 14 days after any of the 6 study visits|The safety population included randomized participants who received >=1 dose of study vaccine and had safety follow-up. Each participant was were counted only once overall.|||Percentage of participants|||Number
2624135|NCT01926015|Primary|Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3|Participant serum was collected for determination of antibody responses. Threshold levels for seroresponse were the following: Diphtheria Toxin, >=0.1 International Units (IU)/mL; Tetanus Toxin, >=0.01 IU/mL; Pertussis Toxin and Pertussis FHA, >=10 Enzyme Units (EU)/mL; Poliovirus Types 1, 2, and 3, neutralizing antibody (NA) titer >=8.|4 to 6 weeks after the third dose of DTP-IPV|The per-protocol population included participants who received the 3 scheduled doses of DTP-IPV according to guidelines and did not have an important protocol deviation that may substantially affect the results of the endpoint|||Percentage of participants|||Number
2624136|NCT01925989|Secondary|Change in RQ, Pre-breakfast to Post-breakfast Meal, in T1DM|The respiratory quotient (or RQ or respiratory coefficient), is a number used in calculations of basal metabolic rate (BMR) when estimated from carbon dioxide production. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole room calorimetry.|Day 30 0830 to 0854 hours, Day 30 1000 to 1054 hours|All randomized participants with T1DM that received at least 1 dose of study drug. Data from 2 participants could not be used: one due to uncontrolled blood glucose and one due to an increase in thyroid medication.|||ratio||Standard Deviation|Mean
2624137|NCT01925989|Secondary|Total Number of Minutes of Lipid Oxidation (RQ Below 7.6) in T1DM and Healthy Participants|The respiratory quotient (or RQ or respiratory coefficient), is a number used in calculations of basal metabolic rate (BMR) when estimated from carbon dioxide production. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole room calorimetry.It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole data based on all 1-minutes interval measurements for the duration of the overnight period.|Day 5, every minute through 23 hour period|All randomized participants: T1DM participants that received at least 1 dose of study drug, Data from 2 participants could not be used:one due to uncontrolled blood glucose and one due to an increase in thyroid medication,data from 2 participants could not be used: 1 due to uncontrolled blood glucose and 1 due to an increase in thyroid medication.|||minutes||Full Range|Median
2624138|NCT01925989|Secondary|Sleep Respiratory Quotient (RQ) of Untreated Healthy Participants|The respiratory quotient (or RQ or respiratory coefficient), is a number used in calculations of basal metabolic rate (BMR) when estimated from carbon dioxide production. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole room calorimetry. The overnight period was averaged based on all 1-minutes interval measurements for the duration of the overnight period.|Day 5, overnight period (0000 to 0600 hours)|All randomized, health participant who received no study drug.|||ratio||Standard Deviation|Mean
2624139|NCT01925989|Secondary|Basal Metabolic Rate (BMR) for T1DM|BMR is the metabolic rate determined at rest 12 to 14 hours after the last meal.|Day 30 post dose, overnight period (0000 to 0600 hours)|All randomized participants with T1DM that received at least 1 dose of study drug. Data from 2 participants could not be used: one due to uncontrolled blood glucose and one due to an increase in thyroid medication.|||kcal/day||Standard Deviation|Mean
2624140|NCT01925989|Secondary|Lipid Oxidation in T1DM and Healthy Participants|Lipid oxidation is derived from RQ, basal metabolic rate and urinary nitrogen, a value of 0.7 indicates that lipids are being metabolized.|Day 30 post dose, overnight period (0000 to 0600 hours)|All randomized participants.|||grams per day (g/day)||Standard Deviation|Mean
2624141|NCT01925989|Primary|Sleep Respiratory Quotient (RQ) in Type 1 Diabetes Mellitus (T1DM)|Lipid or glucose metabolism was assessed by the measurement of respiratory quotient (RQ) during sleep using whole room calorimetry. RQ is a calculation of basal metabolic rate (BMR) when estimated from carbon dioxide production. It is calculated from the ratio of carbon dioxide produced by the body to oxygen consumed by the body using whole room calorimetry (WRC).|Day 30 post dose, overnight period (0000 to 0600 hours)|All randomized participants with T1DM that received at least 1 dose of study drug. Data from 2 participants could not be used: one due to uncontrolled blood glucose and one due to an increase in thyroid medication.|||ratio||Standard Deviation|Mean
2624142|NCT01925950|Primary|Gastrointestinal (GI) Graft-vs-Host Disease (GVHD) Symptoms|"Patients who achieved a Complete Response (CR) of their GI GVHD Symptoms during the Part 1, 16 week treatment period and who remained a CR at the end of the 16 week treatment period were to be eligible to continue into Part 2 of the study. All others were to discontinue.~GI GVHD was assessed using a composite score based on the symptoms of satiety, nausea/vomiting, and anorexia. Each symptom was scored on a scale of 0-3, such that the minimum score = 0 and the maximum score = 9. At entry, all subjects must have a score of ≥ 3. A CR will be defined as a composite score of 0."|16 weeks||||Participants|||Count of Participants
2624143|NCT01925781|Secondary|Point Prevalence Abstinence|No smoking in the previous 7 days. Self report will be biochemically confirmed with expired CO and salivary cotinine.|12 weeks||||participants|||Number
2624144|NCT01925781|Primary|Sustained Abstinence|No smoking at 12 weeks after the predetermined quit date with a 5 day grace period. Self-report will be biochemically confirmed with expired carbon monoxide (CO) and salivary cotinine.|12 weeks||||participants|||Number
2624145|NCT01925768|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-Exposure Period|A TEAE is an AE with a start date on or after the date of the first dose of Investigational Product (IP). An AE is any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.|Start of lst dose of IP up to week 104: Weeks 0 to104 for those initially randomized to APR 30 mg BID, Weeks 16 -104 for PBO-treated patients who EE to APR at Week 16 and from Weeks 24-104 for PBO-treated patients who transitioned to APR at Week 24|APR participants as treated (AAT) population; AAT = participants who received at least 1 dose of APR at any time during the study, (those initially randomized to the APR 30 BID at Week 0, those initially randomized to placebo who entered EE and transitioned to APR at Week 16, and those initially randomized to PBO who transitioned to APR at Week 24)|||Participants|||Number
2624146|NCT01925768|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) During the 24 Week Placebo Controlled Phase|A TEAE is an AE with a start date on or after the date of the first dose of Investigational Product (IP). An AE is any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.|Date of first dose of study drug to Week 24; median duration of exposure during placebo controlled phase was 24.14 weeks|Safety population includes all participants who were randomized and received at least one dose of IP.|||Participants|||Number
2624147|NCT01925768|Secondary|Percentage of Participants Whose Severity of Morning Stiffness at Week 52 and 104 Improved From Baseline|Morning stiffness severity was the participant's assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment.|Baseline and Weeks 52 and 104|Apremilast participants as randomized or transitioned. The Placebo/30 mg BID group includes subjects initially randomized to placebo and switched to apremilast 30 mg BID at Week 16 or 24 and with available data at each time point|||percentage of participants|||Number
2624148|NCT01925768|Secondary|Change From Baseline in the Duration of Morning Stiffness at Weeks 52 and 104|Morning stiffness was the participant's assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A higher value indicates longer duration, and a negative change from baseline indicates improvement.|Baseline and Weeks 52 and 104|Apremilast participants as randomized or transitioned; The Placebo/ Apremilast 30 mg BID group includes participants initially randomized to placebo and switched to apremilast 30 mg BID at Week 16 or 24 And with available data at each time point.|||minutes||Standard Deviation|Mean
2624149|NCT01925768|Secondary|Change From Baseline in 36-item SF-36 (V2.0) Physical Functioning Domain Score at Weeks 52 and 104|The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Weeks 52 and 104|Apremilast Subjects as Randomized or Transitioned; The Placebo/30 mg BID group includes participants initially randomized to placebo and switched to apremilast 30 mg BID at Week 16 or 24and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2624150|NCT01925768|Secondary|Change From Baseline in the Disease Activity Score (DAS28) at Week 52 and 104|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement."|Baseline and Weeks 52 and 104|Apremilast participants as randomized or transitioned. The Placebo/Apremilast30 mg BID group includes participants initially randomized to placebo and switched to apremilast 30 mg BID at Week 16 or 24 and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2624151|NCT01925768|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 52 and 104|HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.|Baseline and Weeks 52 and 104|Apremilast participants as randomized or transitioned; The Placebo/Apremilast 30 mg BID group includes participants initially randomized to placebo and switched to apremilast 30 mg BID at Week 16 or 24 and with available data at each time point.|||units on a scale||Standard Deviation|Mean
2624152|NCT01925768|Secondary|Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Weeks 52 and 104|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]);~Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS);~Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-Reactive Protein (CRP)"|Baseline and Weeks 52 and 104|Apremilast Participants as Randomized or Transitioned, which includes all participants who randomized or escaped/transitioned (at Week 16 or Week 24) to apremilast, and with available data at each time point.|||percentage of partcipants||95% Confidence Interval|Number
2624153|NCT01925768|Secondary|Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4, 6, 8, 12 and 20|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]);~Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS);~Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-Reactive Protein (CRP)"|Baseline and at Weeks 2, 4, 6, 8, 12 and 20|Full analysis set; participants discontinued early prior to the visit and participants who did not have sufficient data for a definitive determination of response status for the visit were counted as nonresponders.|||percentage of participants|||Number
2624154|NCT01925768|Secondary|Percentage of Participants Whose Severity of Morning Stiffness at Week 16 Improved From Baseline|Morning stiffness severity was the participant's assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment. Full Analysis Set; Participants who discontinued early prior to Week 16 and those who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.|Baseline and Week 16|Full Analysis Set; Participants who discontinued early prior to Week 16 and those who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders|||percentage of participants|||Number
2624155|NCT01925768|Secondary|Mean Change From Baseline in the Duration of Morning Stiffness at Week 16|Morning stiffness was the participant's assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A higher value indicates longer duration, and a negative change from baseline indicates improvement.|Baseline and Week 16|Full analysis set; Analysis includes participants with a baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used|||minutes||Standard Deviation|Mean
2624156|NCT01925768|Secondary|Change From Baseline in 36-item Short Form Health Survey (SF-36) V 2 Physical Functioning Domain at Week 16|The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value during the placebo-controlled phase were included in the mixed effects model for repeated measures (MRMM).|||units on a scale||Standard Error|Least Squares Mean
2624157|NCT01925768|Secondary|Change From Baseline in the Disease Activity Score DAS28 (CRP) at Week 16|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A negative change from baseline indicates improvement."|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value during the placebo-controlled phase were included in the mixed effects model for repeated measures (MRMM).|||units on a scale||Standard Error|Least Squares Mean
2624185|NCT01925417|Secondary|Absence of CDAD at 56 Days|Number of participants who were determined to be free of CDAD at Day 56 after receiving their last dose of RBX2660.|56 days|31 subjects had evaluable data at 56 days.|||participants with treatment success|||Number
2624186|NCT01925417|Secondary|Long-term Safety|The incidence of serious adverse events will be assessed through 6 months after the last treatment with RBX2660.|6 months|31 subjects had evaluable data at 6 months.|||number of reported SAEs|||Number
2624158|NCT01925768|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16|HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.|Baseline and Week 16|Full analysis set; participants with a baseline value and at least 1 postbaseline value during the placebo-controlled phase were included in the mixed effects model for repeated measures (MRMM).|||units on a scale||Standard Error|Least Squares Mean
2624159|NCT01925768|Secondary|Percentage of Participants With Improved Change in Severity of Morning Stiffness at Week 24|Morning stiffness severity was the participant's assessment of how severe their morning stiffness was after first waking up in the morning, on average, during the previous week. The severity was recorded as none, mild, moderate, moderately severe, or very severe. The response of no improvement includes subjects who had no change or worsened. Improvement is defined as the change from baseline of a more severe assessment to less severe assessment.|Baseline and Week 24|Full Analysis Set; Participants who withdrew early or who did not have sufficient data at Week 24 were counted as non-responders|||percentage of participants|||Number
2624160|NCT01925768|Secondary|Change From Baseline in the Duration of Morning Stiffness at Week 24|Morning stiffness was the participant's assessment of how long their morning stiffness lasted after first waking up in the morning, on average, during the previous week. A higher value indicates longer duration, and a negative change from baseline indicates improvement.|Baseline and Week 24|Full Analysis Set; Analysis includes participants with a baseline and at least one post-baseline value; last observation carried forward (LOCF) imputation was used|||minutes||Standard Deviation|Mean
2624161|NCT01925768|Secondary|Change From Baseline in the 36-item SF-36 Physical Component Summary Score at Week 24|The SF-36 (v 2.0) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The physical component summary (PCS) score includes the physical functioning, role physical, bodily pain, and general health domains. Minimum clinically important difference (MCID) for the scale scores, as well as the PCS and MCS, is defined as a 2.5-point improvement (increase) from baseline. The summary scores range from 0 to 100, with lower scores reflecting more disability, and higher scores reflecting less disability and better health. The 8 domains are regrouped into the PCS and MCS scores.|Baseline and Week 24|Full analysis set. Subjects with a baseline value and at least one post-baseline value (after exclusion of data for early escaped subjects) during the placebo-controlled phase are included in the MMRM model.|||units on a scale||Standard Error|Least Squares Mean
2624162|NCT01925768|Secondary|Change From Baseline in the Medical Outcomes Short Form Health Survey (SF-36) V2 Physical Function Domain Score at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from baseline score indicates an improvement.|Baseline and Week 24|Full analysis set; Participants with a baseline and at least 1 postbaseline value during the placebo-controlled phase were included in the analysis (mixed effects model for repeated measure [MMRM])|||units on a scale||Standard Error|Least Squares Mean
2624163|NCT01925768|Secondary|Change From Baseline in the 28-Joint Disease Activity Score Using C-reactive Protein as the Acute-Phase Reactant (DAS28 [CRP]) at Week 24|"The DAS28 measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count~28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee;~C-reactive protein (CRP)~Patient's global assessment of disease activity. DAS28 (CRP) scores range from 0 to 9.4. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission. A higher value indicates higher disease activity, and a negative change from baseline indicates improvement."|Baseline and Week 24|Full analysis set; Participants with a baseline value and at least one post-baseline value (after exclusion of data for early escaped participants) during the placebo-controlled phase are included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2624164|NCT01925768|Secondary|Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) at Week 24|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]);~Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS);~Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-Reactive Protein (CRP) Those who withdrew early or who did not have sufficient data at Week 16 were counted as non-responders."|Baseline and Week 24|FAS population.|||percentage of participants|||Number
2624182|NCT01925469|Primary|Change in Pain Score|The primary outcome is the difference in pain score using a validated visual analog scale before the procedure, which is designated as the pre-procedure (or baseline) pain score to the maximum pain during procedure (designated as time 0) These two pain scores will be subtracted and the change in pain score will be reported. The validated visual analog scale allows patients to report pain on a scale of 0 to 100 mm long. At the beginning and at the end, there are two descriptors representing extremes of pain (i.e. no pain = 0 and extreme pain = 100). The patient rated her pain by making a vertical mark on the 100-mm line. The measurement in millimeters was converted to the same number of points ranging from 0 to 100 points. There are no subgroups.|Pre-procedure (Baseline) and procedure (Time 0)||||mm||95% Confidence Interval|Median
2624165|NCT01925768|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24|HAQ-DI is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A higher score indicates worse physical functioning, and a negative change from baseline indicates improvement.|Baseline and Week 24|Full analysis set; Participants with a baseline and at least 1 postbaseline value during the placebo-controlled phase were included in the analysis (mixed effects model for repeated measure [MMRM])|||units on a scale||Standard Error|Least Squares Mean
2624166|NCT01925768|Primary|Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 16|"Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met:~≥ 20% improvement in 78 tender joint count;~≥ 20% improvement in 76 swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Patient's self-assessment of pain (measured on a 0 to 10 unit numeric rating scale [NRS]);~Patient's global self-assessment of disease activity (measured on a 0 to 10 unit NRS);~Physician's global assessment of disease activity (measured on a 0 to 10 unit NRS);~Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);~C-Reactive Protein (CRP) Those who withdrew early or who did not have sufficient data at Week 16 were counted as non-responders."|Baseline and Week 16|Full Analysis Set (FAS) population consisting of all participants randomized as specified in the protocol.|||percentage of participants|||Number
2624167|NCT01925703|Secondary|Serum Ferritin Level|Change in serum ferritin level compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion|Baseline and at follow-up within 1-4 weeks|All participants who achieved complete iron repletion for whom follow up data were available.|||nanograms per milliliter||95% Confidence Interval|Mean
2624168|NCT01925703|Secondary|Transferrin Saturation|Change in transferrin saturation compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion|Baseline and at follow-up within 1-4 weeks|All patients who achieved complete iron repletion for whom follow-up data were available.|||Percentage of transferrin saturation||95% Confidence Interval|Mean
2624169|NCT01925703|Primary|Serum Hemoglobin Concentration|Change in serum hemoglobin concentration compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion|Baseline and at follow-up within 1-4 weeks|All patients who achieved complete iron repletion for whom follow up data were available.|||grams per deciliter||95% Confidence Interval|Mean
2624170|NCT01925677|Secondary|The Comparison of Surgeon Ergonomic Questionnaires in Robotic Assisted Versus Standard Laparoscopic Single Port Donor Nephrectomies.|A surgeon ergonomics questionnaire will be given to surgeons after performing both robotic assisted and standard laparoscopic single port donor nephrectomies. The results from both of these surveys will then be compared. These are qualitative and were not analyzed for statistical trends.|intra-operative experience collected within 24 hours|surgeon questionnaire|||participants|||Number
2624171|NCT01925677|Secondary|Blood Loss|Blood loss of patients will be closely monitored and recorded.|during operation||||mL||Standard Deviation|Mean
2624172|NCT01925677|Secondary|Operative Times|Operative times will closely be measured|during operation||||minutes||Standard Deviation|Mean
2624173|NCT01925677|Primary|Successful Completion of the Surgical Procedure|The primary objective is to determine the feasibility measure of the current Single-Site platform to perform donor nephrectomy prior to vascular division and extraction. Specifically, it will be recorded which portions of the operation utilized the robotic device. The primary outcome variable is the completion of the operation for kidney donation.|during operation||||Participants|||Count of Participants
2624174|NCT01925612|Secondary|Overall Survival|Median overall survival (in months) and observed minimum-maximum range.|Up to approximately 4 years||||Months||Full Range|Median
2624175|NCT01925612|Secondary|Progression-free Survival|Median progression-free survival (in months) and observed minimum-maximum range.|Up to approximately 4 years||||Months||Full Range|Median
2624176|NCT01925612|Secondary|Objective Response Rate|Number (count) of participants that achieved complete or partial remission at the end of treatment according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007)|Up to 6 months||||Participants|||Count of Participants
2624177|NCT01925612|Primary|Incidence of Laboratory Abnormalities|Number (count) of participants that experienced a Grade 3 or higher maximum post-baseline laboratory toxicity (hematology and chemistry). Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Grade 1 = mild, no intervention needed; Grade 2 = moderate, minimal intervention needed; Grade 3 = severe or medically significant, hospitalization is required; Grade 4 = life-threatening, urgent intervention needed; Grade 5 = death related to adverse event.|Up to 6 months||||Participants|||Count of Participants
2624178|NCT01925612|Primary|Incidence of Adverse Events|Number (count) of participants that experienced at least 1 adverse event.|Up to 6 months||||Participants|||Count of Participants
2624179|NCT01925612|Primary|Complete Remission Rate|Number (count) of participants that achieved remission according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).|Up to 6 months||||Participants|||Count of Participants
2624180|NCT01925469|Secondary|Change in Pain Score From Pre-procedure to 5 Minutes Post Procedure.|The patients pain scores will also be assessed at 5 minutes post procedure and the change in pain scores from baseline to this time points will be analyzed. The pain scores will be subtracted to obtain the change in pain score|5 minutes||||mm||95% Confidence Interval|Median
2624181|NCT01925469|Secondary|Patient Satisfaction|The patient's satisfaction will be assessed using a validated satisfaction scale 30 minutes post procedure.|30 minutes post procedure||||participants|||Number
2624183|NCT01925417|Secondary|Post-treatment Hospitalization Data|number of ICU days was collected for subjects who received RBX2660 and who were subsequently hospitalized for recurrent CDAD treatment.|6 months|31 subjects had evaluable data at 6 months.|||number of particpants' ICU days||Full Range|Median
2624187|NCT01925417|Primary|Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660|Safety will be assessed by evaluating the incidence of serious adverse events through 56 days after the last treatment with RBX2660.|56 days|31 subjects had evaluable data at 56 days.|||number of reported SAEs through 56 days|||Number
2624188|NCT01925404|Secondary|Park Use (% Change)|We will count the number of parks users and compare differences between the number counted at baseline to the number counted at follow-up|baseline versus 1 year|Participants were not assigned to study arms|||percentage change in park users|parks|95% Confidence Interval|Mean
2624189|NCT01925404|Primary|Percentage Change in Park-based Physical Activity|Physical activity was measured in MET-hours (Metabolic equivalents)|difference between baseline and follow-up (1 year)|The unit of analysis was at the level of the park.|||Percent change in MET-hours|Parks|95% Confidence Interval|Mean
2624190|NCT01925339|Secondary|Radiographic Marginal Bone Level Change|Mean of mesial and distal marginal bone level changes measured by standard radiographs using customized device. This was measured in millimeters.|Baseline, 1 year|Two subjects withdrew from the study prior to the 1 year time point. Therefore, no data was analyzed for these two subjects.|||milimeters||Standard Deviation|Mean
2624191|NCT01925339|Primary|Mucosal Recession Change|Mucosal level change from baseline to one year was primarily determined by an imaginary line connecting the gingival margin of the adjacent teeth. This was measured in millimeters.|Baseline, 1 year|Two subjects withdrew from the study prior to the 1 year time point. Therefore, no data was analyzed for these two subjects.|||milimeters||Standard Deviation|Mean
2624192|NCT01925274|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Colorectal (FACT-C)|Functional Assessment of Cancer Therapy-Colorectal (FACT-C) was used in this study to assess Health-Related Quality of Life (HRQoL) and CRC-related symptoms in participants enrolled to the randomized portion of the study. The FACT-C is part of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system, a comprehensive and extensive set of self-reported instruments for the assessment of health-related quality of life in participants with cancer or other chronic illnesses.|2 years|Data for this outcome measure were no longer collected after approval of protocol amendment 4, and data previously collected were insufficient to perform any analysis.||||||
2624193|NCT01925274|Secondary|Number of Participants With Expression of Pre-defined Gene Sequences in Biopsied Tumor Tissues|Pre-defined gene sequences were those related to EGFR, PI3K (phosphoinositide-3 kinase) and other oncogenic pathways; examples included but were not limited to PIK3CA (this gene encodes the catalytic subunit of PI3K), PIK3R1 (this gene encodes the regulatory subunit of PI3K), KRAS, NRAS and BRAF (this gene encodes serine/threonine-protein kinase B-Raf) sequences and PIK3CA gene amplification. Due to early termination of this study, these pre-defined gene sequences were not analyzed, except for KRAS and NRAS. Number of participants who had KRAS and NRAS wild type status confirmed by the central laboratory is presented.|2 years|All participants for whom at least one of these pre-defined gene sequences was analyzed were included.|||participants|||Number
2624194|NCT01925274|Secondary|Levels of Signaling Proteins in Paired and Single Tumor Biopsies|Pre defined signaling proteins included Akt (protein kinase B), p-Akt (phosphorylated Akt), p-S6 (phosphorylated ribosomal protein S6), p-Met (phosphorylated Met, a receptor tyrosine kinase), p-mTOR (phosphorylated mammalian target of rapamycin), EGFR (epithelial growth factor receptor), and p-EGFR (phosphorylated EGFR).|2 years|Data for this outcome measure were not collected due to early termination of this study.||||||
2624195|NCT01925274|Secondary|Area Under Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of SN-38|AUCinf refers to the area under plasma concentration time profile from time zero extrapolated to infinite time. AUCinf of SN-38 (an irinotecan metabolite) was calculated using the formula: AUCinf = AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2624196|NCT01925274|Secondary|Area Under Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Irinotecan|AUCinf refers to the area under plasma concentration time profile from time zero extrapolated to infinite time. AUCinf of irinotecan was calculated using the formula: AUCinf = AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2624197|NCT01925274|Secondary|Area Under Plasma Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-05212384|AUCinf refers to the area under plasma concentration time profile from time zero extrapolated to infinite time. AUCinf of PF-05212384 was calculated using the formula: AUCinf = AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2624240|NCT01925014|Secondary|Diagnostic Confidence in Ruling Out Appendicitis: Normal Appendix Visualization|The frequency of normal appendix visualization at CT. Grade 0 denotes appendix not identified; grade 1, unsure or partly visualized; and grade 2, clearly and entirely visualized.|3 months after CT|Patients confirmed as not having appendicitis. Intention-to-treat.|||Participants|||Count of Participants
2624261|NCT01924975|Secondary|Time Required for Overall Successful Venous Cannulation.||10 minutes|Includes only those participants for which successful cannulation was achieved.|||Seconds||Inter-Quartile Range|Median
2624198|NCT01925274|Secondary|Area Under Plasma Concentration Time Profile From Time Zero to the Time for the Last Quantifiable Concentration (AUClast) of SN-38|AUClast refers to the area under plasma concentration time profile from time zero to the time for the last quantifiable concentration. AUClast of SN-38 (an irinotecan metabolite) was determined using linear/log trapezoidal method.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2624199|NCT01925274|Secondary|Area Under Plasma Concentration Time Profile From Time Zero to the Time for the Last Quantifiable Concentration (AUClast) of Irinotecan|AUClast refers to the area under plasma concentration time profile from time zero to the time for the last quantifiable concentration. AUClast of irinotecan was determined using linear/log trapezoidal method.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2624200|NCT01925274|Secondary|Area Under Plasma Concentration Time Profile From Time Zero to the Time for the Last Quantifiable Concentration (AUClast) of PF-05212384|AUClast refers to the area under plasma concentration time profile from time zero to the time for the last quantifiable concentration. AUClast of PF-05212384 was determined using linear/log trapezoidal method.|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2624201|NCT01925274|Secondary|Terminal Elimination Half Life (t½) of SN-38|T½ was calculated as loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||hours||Standard Deviation|Mean
2624202|NCT01925274|Secondary|Terminal Elimination Half Life (t½) of Irinotecan|T½ was calculated as loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||hours||Standard Deviation|Mean
2624203|NCT01925274|Secondary|Terminal Elimination Half Life (t½) of PF-05212384|T½ was calculated as loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||hours||Standard Deviation|Mean
2624204|NCT01925274|Secondary|Time for Maximum Plasma Concentration (Tmax) of SN-38|SN-38 is an irinotecan metabolite. Tmax of SN-38 was observed directly from data as time of first occurrence.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||hours||Full Range|Median
2624205|NCT01925274|Secondary|Time for Maximum Plasma Concentration (Tmax) of Irinotecan|Tmax of irinotecan was observed directly from data as time of first occurrence.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||hours||Full Range|Median
2624206|NCT01925274|Secondary|Time for Maximum Plasma Concentration (Tmax) of PF-05212384|Tmax of PF-05212384 was observed directly from data as time of first occurrence.|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.|The pharmacokinetic parameter analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one of the pharmacokinetic parameters of interest estimated. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||hours||Full Range|Median
2624262|NCT01924975|Secondary|Percentage of Participants With Success of Saphenous Vein Cannulation Within 3 Attempts of Needle Insertion, or a 10 Minute Time Period.||10 minutes||||percent of participants|||Number
2624263|NCT01924975|Primary|Percentage of Participants With First Attempt Success of Saphenous Vein Cannulation||10 minutes||||percent of participants|||Number
2624207|NCT01925274|Secondary|Maximum Plasma Concentration (Cmax) of SN-38|SN-38 is an irinotecan metabolite. Cmax of SN-38 was observed directly from data.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic concentration analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one time point with a concentration measurement recorded. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2624208|NCT01925274|Secondary|Maximum Plasma Concentration (Cmax) of Irinotecan|Cmax of irinotecan was observed directly from data.|Pre-dose (0 hour), 1.5, 2, 4, 6 and 24 hours post irinotecan infusion on Cycle 1 Day 1 and Cycle 2 Day 1.|The pharmacokinetic concentration analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one time point with a concentration measurement recorded. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2624209|NCT01925274|Secondary|Maximum Plasma Concentration (Cmax) of PF-05212384|Cmax of PF-05212384 was observed directly from data.|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 24, 72, 120 hours post PF-05212384 infusion on Cycle 1 Day 9 and Cycle 1 Day 16.|The pharmacokinetic concentration analysis set included all randomized participants (or enrolled participants to the Japanese LIC) who started treatment and had at least one time point with a concentration measurement recorded. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm: “Cetuximab + Irinotecan: Arm B”.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2624210|NCT01925274|Secondary|Number of Participants With ECG Maximum Increase From Baseline Meeting Pre-defined Criteria|"The number of participants with ECG maximum increase from baseline meeting the following criteria was reported:~Criterion A: maximum QTc interval increase from baseline >30 msec and ≤60 msec; criterion B: maximum QTc interval increase from baseline >60 msec; criterion C: maximum QTcB interval increase from baseline >30 msec and ≤60 msec; criterion D: maximum QTcB interval increase from baseline >60 msec; criterion E: maximum QTcF interval increase from baseline >30 msec and ≤60 msec; criterion F: maximum QTcF interval increase from baseline >60 msec."|2 years|QTc analysis set included all participants in the safety analysis set who had at least one ECG assessment after receiving study treatment.|||participants|||Number
2624211|NCT01925274|Secondary|Number of Participants With ECG Post-Baseline Maximum Absolute Values Meeting Pre-defined Criteria|The number of participants with ECG post-baseline maximum absolute values meeting the following criteria was reported: (1) maximum QTc interval ranged from 450 to 480 msec; >480-500 msec; >500 msec; (2) maximum QTcB (QT corrected for heart rate using Bazett's formula) interval ranged from 450 to 480 msec; >480-500 msec; >500 msec; (3) maximum QTcF (QT corrected for heart rate using Fridericia's formula) interval ranged from 450 to 480 msec; >480-500 msec; >500 msec.|2 years|QTc analysis set included all participants in the safety analysis set who had at least one ECG assessment after receiving study treatment.|||participants|||Number
2624212|NCT01925274|Secondary|Number of Participants With Laboratory Test (Coagulation) Abnormalities|Coagulation analysis included partial thromboplastin time (PTT) and international normalized ratio (INR) or prothrombin time (PT).|2 years|Safety analysis set included all participants who received at least one dose of study treatment, with treatment arm assignment designated according to actual study treatment received.|||participants|||Number
2624213|NCT01925274|Secondary|Number of Participants With Laboratory Test (Urinalysis) Abnormalities|Urinalysis included urine dipstick for protein and blood: if positive, perform a microscopic analysis. Number of participants with urine protein tested positive is presented.|2 years|Safety analysis set included all participants who received at least one dose of study treatment, with treatment arm assignment designated according to actual study treatment received.|||participants|||Number
2624214|NCT01925274|Secondary|Number of Participants With Laboratory Test (Chemistry) Abnormalities|The following chemistry parameters were evaluated in this study: sodium, potassium, magnesium, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, albumin, blood urea nitrogen (BUN) or urea, creatinine, total calcium, glycosylated hemoglobin (HbA1c), glucose, uric acid, phosphorus or phosphate, insulin, and C-peptide.|2 years|Safety analysis set included all participants who received at least one dose of study treatment, with treatment arm assignment designated according to actual study treatment received.|||participants|||Number
2624215|NCT01925274|Secondary|Number of Participants With Laboratory Test (Hematology) Abnormalities|The following hematology parameters were evaluated in this study: hemoglobin, white blood cells (WBC) with differential, and platelets.|2 years|Safety analysis set included all participants who received at least one dose of study treatment, with treatment arm assignment designated according to actual study treatment received.|||participants|||Number
2624216|NCT01925274|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Common Terminology Criteria for Adverse Events (CTCAE) Grade|TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug. CTCAE version 4.0 was used to grade the severity of TEAEs. Grade 1 referred to mild AEs; Grade 2 referred to moderate AEs; Grade 3 referred to severe AEs; Grade 4 referred to AEs with life-threatening consequences, and urgent intervention was needed to manage them; Grade 5 referred to death related to AE.|Administration of the first dose of study drug through 28 calendar days after the last administration of study drug|Safety analysis set included all participants who received at least one dose of study treatment, with treatment arm assignment designated according to actual study treatment received.|||participants|||Number
2624241|NCT01925014|Secondary|Diagnostic Confidence in Diagnosing and Ruling Out Appendicitis: Indeterminate Interpretation (Grade 3)|The frequency of indeterminate CT interpretation (grade 3). Grade 1 denotes appendicitis definitely absent; grade 2, appendicitis probably absent; grade 3, indeterminate for the presence of appendicitis; grade 4, appendicitis probably present; and grade 5, appendicitis definitely present.|3 months after CT|Patients with incomplete reference standards were not included in these analyses. Intention-to-treat.|||Participants|||Count of Participants
2624316|NCT01924533|Secondary|Time to Response|Time from randomization to the first onset of a confirmed objective tumour response|Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years|Patients with objective response in full analysis set population|||days||Inter-Quartile Range|Median
2624217|NCT01925274|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE was defined as any untoward occurrence at any dose that resulted in death; was life threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. AEs included both serious and non-serious AEs. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study drug.|Administration of the first dose of study drug through 28 calendar days after the last administration of study drug|Safety analysis set included all participants who received at least one dose of study treatment, with treatment arm assignment designated according to actual study treatment received.|||participants|||Number
2624218|NCT01925274|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the duration from enrollment to death. Participants last known to be alive were censored at date of last contact.|2 years|Per protocol analysis set, i.e. all participants who were randomized, with KRAS and NRAS wild type status confirmed by central lab and with treatment arm assignment designated according to randomization. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm “PF 05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)”.|||months||95% Confidence Interval|Median
2624219|NCT01925274|Secondary|Duration of Response|For participants with an objective response (CR or PR), duration of response was defined as the time from first documentation of CR or PR to date of first documentation of objective progression or death. Date of first documentation of progression and date of first documentation of CR or PR were based on Investigator's assessment of response.|2 years|The analysis population included all participants who achieved CR or PR in Arm A and Arm B. As pre-specified in protocol, this outcome measure was not analyzed for reporting arm “PF 05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)”.|||months||95% Confidence Interval|Median
2624220|NCT01925274|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1. Confirmed PR was defined as disappearance of all target lesions. Confirmed PR was defined as >=30% decrease in sum of the longest dimensions of the target lesions taking the baseline sum as a reference. Confirmed responses were those that persisted on repeat imaging study >=4 weeks after initial documentation of response.|2 years|Response evaluable analysis set was used for the analysis of objective response, and it included all participants in the full analysis set (all participants who were randomized, with treatment arm assignment designated according to randomization) who had an adequate baseline assessment of disease and measurable disease.|||percentage of participants||95% Confidence Interval|Number
2624221|NCT01925274|Secondary|Number of Participants With Unacceptable Toxicity in Cycle 1 (Japanese LIC Only)|Unacceptable toxicity (according to Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0) was any of the following occurrences: (1) Grade 4 neutropenia >7 days, or febrile neutropenia, or Grade 4 thrombocytopenia; (2) Grade >=3 nausea/vomiting despite optimal antiemetic treatment, or Grade >=3 diarrhea despite optimal anti diarrheal treatment; (3) unmanageable Grade >=3 hyperglycemia; (4) mean QTc interval (time from electrocardiogram [ECG] Q wave to the end of the T wave corresponding to electrical systole, corrected for heart rate) >501 msec in triplicate 12-lead ECG, or myocardial infarction, or ventricular arrhythmia; (5) Grade >=3 non-hematologic toxicity; (6) treatment delay of >=2 weeks due to study drug related toxicity; (7) persistent, intolerable toxicities which resulted in failure to deliver at least 75% of doses of both PF-05212384 and irinotecan during Cycle 1; (8) Grade >=2 respiratory toxicities.|28 days|The analysis population included all participants enrolled into Japanese LIC. As pre-specified in protocol, this outcome measure was not analyzed for reporting arms: “PF-05212384 + Irinotecan: Arm A” and “Cetuximab + Irinotecan: Arm B”.|||participants|||Number
2624222|NCT01925274|Primary|Progression Free Survival (PFS) as Assessed by Investigators|Progression-free survival (PFS) was the time from the first dose of study treatment to the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. Median PFS was estimated based on the Kaplan-Meier method.|From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years|All participants who were randomized, with KRAS (Kirsten ras oncogene) and NRAS (neuroblastoma ras viral oncogene homolog) wild type status confirmed by central lab, and with treatment arm assignment designated according to randomization. As pre-specified in the protocol, this outcome measure was not analyzed for Japanese Lead-In Cohort.|||months||95% Confidence Interval|Median
2624223|NCT01925209|Secondary|Change From Baseline in Short Physical Performance Battery (SPPB) Score at Week 52|The SPPB evaluated lower extremities function by testing gait speed, ability to keep standing balance and time to rise from a chair five times. The sub-score for each test ranged from 0 to 4. The summary score, which was a summation of scores from the 3 tests, ranged from 0 to 12. An increase in score indicates improvement in physical performance. A negative change from baseline indicates deterioration.|Baseline, Week 52|The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was analyzed.|||score on a scale||Standard Error|Least Squares Mean
2624224|NCT01925209|Secondary|Estimated Annual Number of Falls Per Patient Within Treatment Group|Participants documented any fall occurrences in a paper diary during the study.|Week 52|The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was analyzed.|||Annual number of falls per participant|||Number
2624256|NCT01924988|Secondary|International Prostate Symptom Score (IPSS)|Measure Description: Validated patient reported questionnaire to assess the severity of lower urinary tract symptoms associated with benign prostatic enlargement. Severity of symptom scores range from 0 to 35, with a score of 0-7 considered mild, 8-19 moderate and 20 to 35 severe symptoms.|1week, 3 months, 6months, 12months|Some participants did not complete follow-up|||score on a scale||Full Range|Mean
2624225|NCT01925209|Secondary|Change From Baseline in Sporadic Inclusion Body Myositis (sIBM) Functional Assessment (sIFA) Score at Week 52|Self-reported physical function was assessed by a newly developed patient reported outcome named sporadic inclusion body myositis (sIBM) functional assessment (sIFA). The sIFA consists of 11 items scored on an 11 point numerical rating scale from 0 (no difficulty) to 10 (unable to do) across 3 domains: upper body functioning, lower body functioning and general functioning. Participants completed the assessment where the recall period was the past week prior to completing the patient reported outcome (PRO). The total score on the sIFA scale ranges from 0 (minimum) to 110 (maximum). Higher values represent a worse outcome. A positive change from baseline indicates deterioration.|Baseline, Week 52|The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was considered for the analysis. Only those participants from the FAS who had both baseline and week 52 sIFA measurements were analyzed.|||score on a scale||Standard Error|Least Squares Mean
2624226|NCT01925209|Secondary|Change From Baseline in Quadriceps Quantitative Muscle Testing (QMT) on the Right Side at Week 52|Quadriceps muscle strength was measured by portable fixed dynamometry (PFD) on the right side. A negative change from baseline indicates deterioration.|Baseline, Week 52|The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was considered for the analysis. Only those participants from the FAS who had both baseline and week 52 QMT measurements were analyzed.|||newtons||Standard Error|Least Squares Mean
2624227|NCT01925209|Secondary|Estimated Within Treatment Group Lean Body Mass (LBM) Ratio at Week 52|LBM was measured via dual energy x-ray absorptiometry (DXA) and calculated as (LBM at Week 52/LBM at baseline)*100 . A positive change from baseline indicates improvement.|Baseline, Week 52|The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was considered for the analysis. Only those participants from the FAS who had both baseline and week 52 LBM measurements were analyzed.|||Percentage||95% Confidence Interval|Number
2624228|NCT01925209|Primary|Change From Baseline in 6 Minute Walking Distance (6MWD) Test at Week 52|The 6MWD test measured the distance (in meters) that a participant walked in a 6 minute timeframe. A positive change from baseline indicates improvement.|Baseline, Week 52|The Full Analysis Set (FAS), which included all randomized participants who had received at least one dose of study drug and had at least one post-baseline efficacy assessment, was considered for the analysis. Only those participants from the FAS who had both baseline and week 52 6MWD measurements were analyzed.|||meters||Standard Error|Least Squares Mean
2624229|NCT01925183|Primary|Proportions of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)||Baseline (BL) to Follow-up week 12 (FU12)||||Participants|||Count of Participants
2624230|NCT01925183|Primary|Proportion of Subjects With Sustained Virologic Response (SVR12)|Defined as HCV-RNA negativity by a sensitive assay|Follow-up week 12 (FU12)||||Participants|||Count of Participants
2624231|NCT01925170|Secondary|Biopsy Rate|Biopsy rate = number of participants who had a biopsy/number of number of participants analyzed.|12 months after mammography and MBI||||percentage of participants||95% Confidence Interval|Number
2624232|NCT01925170|Secondary|Recall Rate|Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or MBI.|12 months after mammography and MBI|The analysis population only included participants with a verified cancer status at 12 months after the initial screening (mammography and MBI).|||percentage of participants||95% Confidence Interval|Number
2624233|NCT01925170|Secondary|Sensitivity for All Cancers Diagnosed|Sensitivity measures the percentage of actual positives which are correctly identified as such.|Within 21 days of mammography|The analysis population only included participants with a verified cancer status at 12 months after the initial screening. 21 participants out of the total study population of 1585 were diagnosed with cancer.|||percentage of actual positives||95% Confidence Interval|Number
2624234|NCT01925170|Secondary|Specificity|Specificity measures the percentage of negatives which are correctly identified as such.|Within 21 days of mammography|The analysis population only included participants with a verified negative cancer status at 12 months after the initial screening (mammography and MBI).|||percentage of true negatives||95% Confidence Interval|Number
2624235|NCT01925170|Primary|Cancer Detection Rate Per 1000 Women Screened, by Breast Density|The cancer detection rate per 1000 women screened is the estimate of the number of women with positive results from a screening test.|Within 21 days of mammography||||cancers per 1000 women screened||95% Confidence Interval|Number
2624236|NCT01925144|Primary|PK: Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib||Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + omeprazole in Period 2) and had PK data to calculate AUC(0-∞) of baricitinib.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2624237|NCT01925144|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib||Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + omeprazole in Period 2) and had PK data to calculate Tmax of baricitinib.|||hours||Full Range|Median
2624238|NCT01925144|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib||Days 1 and 10: predose of baricitinib, 0.5, 0.75, 1, 2, 3, 4, 6, 12, 24, 36 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + omeprazole in Period 2) and had PK data to calculate Cmax of baricitinib.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2624239|NCT01925014|Secondary|Diagnosis of Appendiceal Perforation at CT|"Diagnostic sensitivity: the number of correct detections of the perforation divided by the number of cases of perforated appendicitis.~Diagnostic specificity: the number of correct ruling out the perforation divided by the number of cases of appendicitis without perforation."|3 months after CT|Patients confirmed to have appendicitis. Intention-to-treat.|||Percentage|||Number
2624257|NCT01924988|Primary|Detection of a Bladder Injury by Cystoscopy|Number of patients with a bladder injury detected by cystoscopic examination|12 months after the procedure||||Participants|||Count of Participants
2624242|NCT01925014|Secondary|Diagnostic Confidence in Diagnosing and Ruling Out Appendicitis: Likelihood Score for Appendicitis|"Likelihood score for appendicitis in patients confirmed as having appendicitis.~Likelihood score for appendicitis in patients confirmed as not having appendicitis.~Grade 1 denotes appendicitis definitely absent; grade 2, appendicitis probably absent; grade 3, indeterminate for the presence of appendicitis; grade 4, appendicitis probably present; and grade 5, appendicitis definitely present."|3 months after CT|Patients with incomplete reference standards were not included in these analyses. Intention-to-treat.|||Participants|||Count of Participants
2624243|NCT01925014|Secondary|Diagnostic Performance of CT Reports - Sensitivity and Specificity|"Diagnostic sensitivity and specificity: the 5-grade likelihood scores for appendicitis were collapsed into binary responses with a decision threshold of a score ≥ 3 as positive for the diagnosis.~Sensitivity is a proportion of the positive test among the patient confirmed as having appendicitis.~Specificity is a proportion of the negative test among the patient confirmed as not having appendicitis."|3 months after CT|Patients with incomplete reference standards were not included in these analyses. Intention-to-treat.|||percentage|||Number
2624244|NCT01925014|Secondary|Diagnostic Performance of CT Reports - AUC|- Area under the receiver-operating-characteristic curve (AUC).|3 months after CT|Patients with incomplete reference standards were not included in these analyses. Intention-to-treat.|||AUC|||Number
2624245|NCT01925014|Secondary|Length of Hospital Stay Associated With Appendectomy|The interval from CT acquisition to hospital discharge after appendectomy.|3 months after CT|Patients who underwent appendectomy. Intention-to-treat. Interval appendectomies following percutaneous abscess drainage and/or medical treatment were not included in this analysis.|||Days||Inter-Quartile Range|Median
2624246|NCT01925014|Secondary|Delay in Patient Disposition|"The interval from CT acquisition to appendectomy in patients undergoing appendectomy. Interval appendectomies following percutaneous abscess drainage and/or medical treatment were not included in this analysis.~The interval from CT acquisition to hospital discharge in patients not undergoing surgery."|3 months after CT|Intention-to-treat.|||Hours||Inter-Quartile Range|Median
2624247|NCT01925014|Secondary|Need for Additional Imaging Test(s)|The proportion of patients requiring additional imaging test(s) in order to diagnose or rule out appendicitis.|1 week after CT|Intention-to-treat.|||Participants|||Count of Participants
2624248|NCT01925014|Secondary|Prevalence of Non-perforated Appendicitis|The percentage (i.e., prevalence) of non-perforated appendicitis among all randomized cases. In January, 2016, when more than 2000 patients were enrolled, the data and safety monitoring board noted a between-group imbalance in the number of appendectomies. Because of the concern that such an imbalance might potentially jeopardize the comparability for the prespecified endpoints, the study protocol was amended to adopt the following additional secondary endpoints, which were assessed among all randomly assigned patients: the number of appendectomies, number of negative appendectomies, prevalence of perforated appendicitis, and prevalence of non-perforated appendicitis.|1 week after surgery|Intention-to-treat.|||Participants|||Count of Participants
2624249|NCT01925014|Secondary|Prevalence of Perforated Appendicitis|The percentage (i.e., prevalence) of perforated appendicitis among all randomized cases. In January, 2016, when more than 2000 patients were enrolled, the data and safety monitoring board noted a between-group imbalance in the number of appendectomies. Because of the concern that such an imbalance might potentially jeopardize the comparability for the prespecified endpoints, the study protocol was amended to adopt the following additional secondary endpoints, which were assessed among all randomly assigned patients: the number of appendectomies, number of negative appendectomies, prevalence of perforated appendicitis, and prevalence of non-perforated appendicitis.|1 week after surgery|Intention-to-treat.|||Participants|||Count of Participants
2624250|NCT01925014|Secondary|Number of Negative Appendectomies|The percentage of negative appendectomies among all randomized cases. In January, 2016, when more than 2000 patients were enrolled, the data and safety monitoring board noted a between-group imbalance in the number of appendectomies. Because of the concern that such an imbalance might potentially jeopardize the comparability for the prespecified endpoints, the study protocol was amended to adopt the following additional secondary endpoints, which were assessed among all randomly assigned patients: the number of appendectomies, number of negative appendectomies, prevalence of perforated appendicitis, and prevalence of non-perforated appendicitis.|1 week after surgery|Intention-to-treat.|||Participants|||Count of Participants
2624251|NCT01925014|Secondary|Number of Appendectomies|Appendectomy rate. The percentage of appendectomies among all randomized cases.|3 months after CT|Intention-to-treat.|||Participants|||Count of Participants
2624252|NCT01925014|Secondary|Appendiceal Perforation Rate|The percentage of perforated appendicitis among confirmed appendicitis cases.|1 week after surgery|Patients confirmed as having appendicitis. Intention-to-treat.|||Participants|||Count of Participants
2624253|NCT01925014|Primary|Negative Appendectomy Rate|Negative appendectomy rate was defined as the percentage of negative (unnecessary) appendectomies among all non-incidental appendectomies. As a secondary analysis, negative appendectomy rate in an alternative definition was calculated by excluding cases with appendiceal neoplasms without superimposed appendicitis, as appendectomy would be clinically necessary in such patients. Any surgery performed for the treatment of presumed appendicitis was counted as non-incidental appendectomy, even though the surgical procedures were more extensive than simple appendectomy (e.g., ileocectomy).|1 week after surgery|Patients who underwent appendectomy. Intention-to-treat.|||Participants|||Count of Participants
2624254|NCT01924988|Secondary|QMax (Peak Urinary Flow)|Measure Description: measure of the peak urinary flow rate as measured by urine flowmetry. Result is in ml/sec.|1week, 3 months, 6months, 12months|Some participants did not complete follow-up|||milliliters per second||Full Range|Mean
2624255|NCT01924988|Secondary|International Index of Erectile Function (IIEF)- 5|Measure Description: IIEF-5 is a 5 question validated patient reported outcome measure or erectile dysfunction (ED), with a range of scores from 5 to 25, and ED was classified into five categories or erectile function based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).|1week, 3 months, 6months, 12months|Some participants did not complete follow-up|||score on a scale||Full Range|Mean
2624258|NCT01924988|Primary|Detection of a Bladder Injury|Bladder injury detected by cystoscopy|6 months after treatment||||Participants|||Count of Participants
2624259|NCT01924988|Primary|Detection of Bladder Injury|Bladder injury as detected by cystoscopy|3 months after treatment|9 participants failed to complete this follow-up.|||Participants|||Count of Participants
2624264|NCT01924949|Secondary|Percentage of Participants Experiencing Virologic Failure|"Virologic failure was defined as~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline to posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2624265|NCT01924949|Secondary|HCV RNA Change From Baseline||Baseline; Weeks 1, 4, and 8|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
2624266|NCT01924949|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Up to 12 weeks|Full Analysis Set|||percentage of participants|||Number
2624267|NCT01924949|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
2624268|NCT01924949|Primary|Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug|||percentage of participants|||Number
2624269|NCT01924949|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled and received at least 1 dose of study drug|||percentage of participants|||Number
2624270|NCT01924871|Other Pre-specified|Postoperative Pain|The outcomes assessor will evaluate the degree of postoperative pain using a numeric rating scale (NRS). (0 = no pain, 10 = unimaginable severe pain)|Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.|||||||
2624271|NCT01924871|Secondary|Success Rate & Complication Rate Including Cough|We will assess the success rate of deep extubation without complication and the occurrence of cough during emergence from general anesthesia.|assessing the success rate of deep extubation without complication and the occurrance of cough from the completion of surgery to 5minute after extubation.|||||||
2624272|NCT01924871|Primary|Awakening Time|The outcomes assessor will record from the time of extubation in operating room to the time of eye opening and mouth opening|Participants will be followed from the time of extubation in operating room to the time of discharge from recovery room, an expected average of 1day.||||minutes||Inter-Quartile Range|Median
2624273|NCT01924845|Secondary|Number of Participants With Non-Serious AEs|Number of participants with non-serious Adverse Events. Data is taken at final time point of Week 24, compared to baseline. For full AE data, please see AE section.|Baseline through Week 24 +4 weeks follow-up|Full Analysis Set.|||Participants|||Count of Participants
2624274|NCT01924845|Secondary|Percent Predicted Upright Forced Vital Capacity (FVC)|Pulmonary function test: Percent Predicted Upright Forced Vital Capacity|Baseline, Week 24|Full Analysis Set. Please note the Overall Number of Participants reflects the number of patients in the Analysis Population, while the Number Analyzed of patients at specific visit in the Outcome Measure Table reflects the participants who had data at that visit .|||Percent Predicted||Standard Deviation|Mean
2624275|NCT01924845|Secondary|6 Minute Walk Test (Meters)|Distance walked within 6 minutes|Baseline, Week 24|Full Analysis Set. Please note the Overall Number of Participants reflects the number of patients in the Analysis Population, while the Number Analyzed of patients at specific visit in the Outcome Measure Table reflects the participants who had data at that visit .|||Meter||Standard Deviation|Mean
2624276|NCT01924845|Secondary|Percent Predicted Maximum Expiratory Pressure (MEP)|Pulmonary function test: Percent Predicted Maximum Expiratory Pressure|Baseline, Week 24|Full Analysis Set. Please note the Overall Number of Participants reflects the number of patients in the Analysis Population, while the Number Analyzed of patients at specific visit in the Outcome Measure Table reflects the participants who had data at that visit .|||Percent Predicted||Standard Deviation|Mean
2624277|NCT01924845|Primary|Percent Predicted Maximum Inspiratory Pressure (MIP)|Pulmonary function test: Percent Predicted Maximum Inspiratory Pressure|Baseline, Week 24|Full Analysis Set. Please note the Overall Number of Participants reflects the number of patients in the Analysis Population, while the Number Analyzed of patients at specific visit in the Outcome Measure Table reflects the participants who had data at that visit .|||Percent Predicted||Standard Deviation|Mean
2624278|NCT01924806|Secondary|Braden Scale for Predicting Pressure Sore Risk - Total Score|"The Braden Scale, performed by the Investigator (or designee), is a 6-item questionnaire (sensory perception, moisture, activity, mobility, nutrition, and friction &shear) used to assess the subject's level of risk for development of pressure ulcers.~Total score is determined by adding together the sub-scores from each of the 6 items, with a lower score indicating a higher risk for developing pressure ulcers.~Braden Scale thresholds:~19-23 = not at risk 15-18 = preventative interventions 13-14 = moderate risk 10-12 = high risk 6-9 = very high risk~Sub-score ranges:~Sensory perception: 1 - 4 Moisture: 1 - 4 Activity: 1 - 4 Mobility: 1 - 4 Nutrition: 1 - 4 Friction & Shear: 1 - 3~Total score minimum of 6 indicated a very high risk outcome, maximum score of 23 indicated the subject not at risk."|Screening through Visit 8 (12 weeks)|All available subjects at each time point.|||total score on a scale||Standard Deviation|Mean
2624279|NCT01924806|Secondary|Wound Status Using Bates-Jensen Wound Assessment - Total Score|"The Bates-Jensen Wound Assessment Tool is a 13-item questionnaire (size, depth, edges, undermining, necrotic tissue type, exudate type, exudate amount, skin color surrounding wound, peripheral tissue edema, peripheral tissue induration, granulation tissue, epithelialization) used to assess wound status.~Total score is determined by adding together the sub-scores from each of the 13 items, with a higher score indicating a more severe wound status. Each of the 13 item scores ranged from 1 to 5 possible points. Minimum score of 13 indicated the best outcome, maximum score of 65 indicated the worst outcome."|Screening through Visit 8 (12 weeks)|All subjects seen and assessed at each time point.|||total score on a scale||Standard Deviation|Mean
2624332|NCT01924429|Secondary|ASRS - Expanded|ADHD and Related Symptoms Measure (ASRS): self report, reported as Sum of Responses (0-4 per item, higher = more impaired) 0-26 (normal range) and >27 (clinically significant symptoms).|at 4 weeks|not collected||||||
2624280|NCT01924806|Secondary|Photograph Area Measurements to Determine Reduction in Wound Size|a) Reduction in wound size for up to 12 weeks post-debridement Photographs of the wound site were taken to determine the reduction in wound size and to assess healing progression of the study wound. Standardization of images was ensured by the Eykona® Wound Measurement System that uses small sterile 'targets' placed on the study wound to set the focus and position of the camera thus eliminating inconsistency between images acquisition time points. The photographs are stored on a USB (Universal Serial Bus) flash drive which will be archived with the study files.|Visit 2 through Visit 8 (12 weeks)|All treated subjects|||cm^2|||Number
2624281|NCT01924806|Primary|Bacterial Diversity and Number of Bacteria Present in the Wound|"Primary endpoint was to determine bacterial diversity and number of bacteria present in the study wound at 4 weeks post- debridement using either WoundWand Debridement Device or Standard of Care. Punch biopsies were performed per standard practice to quantify the type and amount of bacteria present in wounds debrided with either Standard of Care Sharp Debridement or WoundWand Debridement Device. Debridement of contaminated tissue is essential to prevent wound infection, promote healing, and provide a neat wound edge for the prevention of scaring.~A 3-4 mm punch biopsy for quantitative tissue culture (i.e. bacterial content) will be collected from the study wound site immediately pre- and post-debridement and at Week 4. The punch biopsy will be performed per standard practice and if required, utilizing the appropriate analgesia [e.g. general, local (e.g. 1% lidocaine with epinephrine)]. Quantitative tissue culture will be completed according to the laboratory's standard procedures"|Day 1 (immediately pre- and post-debridement) and 4 weeks post-debridement|All treated subjects|||Log^10 CFU/g|||Number
2624282|NCT01924767|Secondary|Serum Insulin|"Serum insulin measured for on day -2 and day 8 for Emax0-5, Emax0-12, Emin0-5 and Emin0-12.~Emax: Maximum effect (maximum measured concentration of glucose or insulin in plasma) & Emin: Minimum effect (minimum measured concentration of glucose or insulin in plasma)"|0.0h, 2h, 5h, 7h, 10h, 12h on day -2 & day 8|PDS|||µU/mL||Standard Deviation|Mean
2624283|NCT01924767|Secondary|Serum Insulin|"Serum insulin measured for on day -2 and day 8 for AUEC0-5 and AUEC0-12. AUEC0-5: The area under the effect concentration-time curve over the time interval 0 to 5.~AUEC0-12: The area under the effect concentration-time curve over the time interval 0 to 12."|0.0h, 2h, 5h, 7h, 10h, 12h on day -2 & day 8|PDS|||µU*h/mL||Standard Deviation|Mean
2624284|NCT01924767|Secondary|Fasting Plasma Glucose|Percentage change from baseline to Day 8 in fasting plasma glucose. Baseline is defined as Day -2.|-0:30 (Pre dose samples)|PDS|||percentage of fasting plasma glucose||Standard Deviation|Mean
2624285|NCT01924767|Secondary|Mean Daily Glucose|Change from baseline to Day 8 in mean daily glucose. Baseline is defined as Day -2.|0:00, 2:00, 5:00, 7:00, 10:00, 12:00,13:30 and 24:00 hours(h) after drug administration on day -2 and -0.05, 2:30, 5:00, 7:00, 10:00, 12.00, 13:30 and 24:00 hours (h) after drug administration on day 8|PDS|||mg/dL||Standard Deviation|Mean
2624286|NCT01924767|Secondary|Change From Baseline to Day 8 in Urinary Glucose Excretion|Change from baseline to day 8 in urinary glucose excretion. Baseline is defined as Day -2.|-2-0 hours(h) before drug administration and 0-2, 2-4, 4-6, 6-8, 8-12,12-16 and 16-24 h after drug administration on day -2 and day 8|Pharmacodynamic (PD) analysis set (PDS) contains of all patients who received study medication and have evaluable pharmacodynamic parameter data.|||mg||Standard Deviation|Mean
2624287|NCT01924767|Secondary|Accumulation Ratios|"Accumulation ratio based on Cmax (RA,Cmax) and Accumulated ratio based on AUC0-tau (RA,AUC) at steady-state.~Accumulation ratio for the respective doses were calculated using below mentioned equations:~RA,Cmax = Cmax,ss/Cmax~RA,AUC= AUCtau,ss/AUCtau"|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2624288|NCT01924767|Secondary|Linearity Index|The linearity index is defined as AUC0-tau divided by AUC0-∞ both at steady state.|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set|||Fraction||Geometric Coefficient of Variation|Geometric Mean
2624289|NCT01924767|Secondary|Peak Trough Fluctuation|Peak trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set|||PTF(%) of Empagliflozin||Geometric Coefficient of Variation|Geometric Mean
2624290|NCT01924767|Secondary|Apparent and Renal Clearance of the Analyte in Plasma|"Apparent clearance of the analyte in plasma (CL/F) after first dose and at steady-state, Renal clearance of the analyte in plasma after extravascular administration (CLR) after first dose and at steady-state.~Apparent clearance after first dose is defined as the dose divided by AUC0-∞; apparent clearance at steady-state is defined as the dose divided by AUC0-tau at steady-state.~Renal clearance CLR(0-t) is defined as Ae0-t divided by AUC0-t."|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2624291|NCT01924767|Secondary|Fraction of Analyte Excreted Unchanged in Urine|"Fraction of analyte excreted unchanged in urine in the time interval 0 to 12 h (fe0-12) after first dose and at steady-state. The fraction excreted was calculated by dividing Ae0-12 by the Dose and multiply it with 100.~Fraction of analyte excreted unchanged in urine in the time interval 0 to 24 h (fe0-24) after first dose and at steady-state. The fraction excreted was calculated by dividing Ae0-24 by the Dose and multiply it with 100."|0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 hours (h) after dose on day 1 and 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 and 48-72 hours (h) after dose on day 9|PK set|||percent of analyte||Geometric Coefficient of Variation|Geometric Mean
2624292|NCT01924767|Secondary|Amount of Analyte Eliminated in Urine|Amount of analyte that is eliminated in urine after first dose and at steady state from the time interval 0 to 24 h (Ae0-24) and 0 to 48 h (Ae0-48)|0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 hours (h) after dose on day 1 and 0-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 and 48-72 hours (h) after dose on day 9|PK set|||nmol||Geometric Coefficient of Variation|Geometric Mean
2624293|NCT01924767|Secondary|Apparent Volume of Distribution During the Terminal Phase|Apparent volume of distribution during the terminal phase (Vz/F) after first dose and at steady state. Apparent volume is defined as CL/F divided by the terminal rate constant in plasma (either after first dose or at steady-state).|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set|||L||Geometric Coefficient of Variation|Geometric Mean
2624294|NCT01924767|Secondary|Half-life and Mean Residence Time of the Analyte in Plasma|Terminal half life of the analyte in plasma (t1/2) and mean residence time of the analyte in the body after single oral administration (MRTpo) after first dose and at steady-state.|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK Set|||h||Geometric Coefficient of Variation|Geometric Mean
2624295|NCT01924767|Secondary|Terminal Rate Constant in Plasma|Terminal rate constant in plasma after first dose and at steady-state|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1. -0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set|||1/h||Geometric Coefficient of Variation|Geometric Mean
2624296|NCT01924767|Secondary|Time to Maximum Concentration of the Analyte in Plasma|Time from last dosing to maximum concentration of the analyte in plasma (tmax) after first dose and at steady-state|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set|||h||Full Range|Median
2624297|NCT01924767|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval (AUC)|AUC0-∞: from 0 extrapolated to infinity after first dose AUCtau,1: over a uniform dosing interval tau after first dose AUCtau,ss: over a uniform dosing interval tau at steady-state AUCs were computed using the linear up/log down algorithm. If an analyte concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was to be used. If the analyte concentration was smaller than the preceding concentration, the logarithmic method was to be used.|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|PK set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2624298|NCT01924767|Secondary|Concentration of the Analyte in Plasma|Maximum concentration of the analyte in plasma (Cmax) after first dose, Maximum, minimum (Cmin) and average (Cavg) concentration of the analyte in plasma at steady-state, Concentration of analyte in plasma at 24 h after administration of the 8th dose (at steady-state) (C24,8)|-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h and 48h after dose on day 1.-0:05 before dose and 0:10,0:20,0:30,0:40,1h,1:30h,2h,3h,4h,6h,8h,12h,16h,24h,30h,36h, 48h,60h and 72h after dose on day 9.|Pharmacokinetic set (PK set) contains of all patients who received study medication and have evaluable pharmacokinetic parameter data. The PK set will not contain placebo patients.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2624299|NCT01924767|Primary|Assessment of Tolerability by Investigator|Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory and bad.|day 21|Treated set|||percentage of participants|||Number
2624300|NCT01924767|Primary|Micturition Frequency|Micturition frequency is reported as change from pre-treatment to day 9 during the day, the night and total. Baseline is the mean of days 8-3 before drug administration.|Baseline and Day 9|Treated set|||frequency of micturition||Standard Deviation|Mean
2624301|NCT01924767|Primary|Percentage of Participants With Clinically Relevant Findings in Electrocardiogram (ECG) Results|Percentage of participants with clinically relevant findings in electrocardiogram (ECG) results|day 1 to day 21|Treated set|||percentage of participants|||Number
2624302|NCT01924767|Primary|Percentage of Participants With Clinically Relevant Findings in Physical Examination, Vital Signs and Clinical Laboratory Tests|Percentage of participants with clinically relevant findings in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).|day 1 to day 21|Treated set.|||percentage of participants|||Number
2624303|NCT01924689|Secondary|Number of Patients With Local Tumor-specific T-cell Responses|"The host immune and inflammatory response to C. novyi-NT spores was measured in routine blood sampling over the course of the study. Immunostaining for tumor infiltrating cells was analyzed independently by 2 investigators. Respective counting of 3 slides per patient between 5 to 20 fields of vision at 200x were scored using the modified ALLRED scoring method. Respective counts were averaged in each case. Pre and post treatment needle biopsies from injected and non-injected tumors were stained for the presence of tumor infiltrating immune cells.~No patients were analyzed for Cohort 1 and Cohort 2 based on the original study protocol."|2 years|The efficacy data set or full analysis set consisted of all patients in the safety population who had both a baseline tumor assessment and at least one post-baseline tumor assessment. Patients were included in the analysis according to the dose of IMP received.|||Patients|||Number
2624304|NCT01924689|Secondary|Number of Patients With Systemic Tumor Antigen Specific T-cell Responses|"The host immune and inflammatory response to C. novyi-NT spores was measured in routine blood sampling over the course of the study. Release of T-cell cytokines and effector molecules (interferon [IFN]-γ , Granzyme B, and tumor necrosis factor [TNF]-α) from the patient's own peripheral blood mononuclear cells (PBMCs) treated with allogenic tumor cell line lysates were quantified by Enzyme-Linked Immunosorbent Spot (ELISPOT) assays. A positive response was defined as a frequency that is significantly (p <0.05, two-tailed t-test) greater than the mean of control no-antigen wells and detectable (i.e., >1:100,000).~No patients were analyzed for Cohort 1 and Cohort 2 based on the original study protocol."|2 years|The efficacy data set or full analysis set consisted of all patients in the safety population who had both a baseline tumor assessment and at least one post-baseline tumor assessment. Patients were included in the analysis according to the dose of IMP received.|||Patients|||Number
2624333|NCT01924429|Secondary|ASRS - Expanded|ADHD and Related Symptoms Measure (ASRS): self report, reported as Sum of Responses (0-4 per item, higher = more impaired) 0-26 (normal range) and >27 (clinically significant symptoms).|at one week|not collected||||||
2624305|NCT01924689|Secondary|Number of Patients With Cytokine Responses Analyzed|"The host immune and inflammatory response to C. novyi-NT spores was measured in routine blood sampling over the course of the study.~The following table presents the data for the patients who had analyzable cytokine data.~This table was included to simply indicate the number of patients who participated in the cytokine response analysis."|2 years|The efficacy data set or full analysis set consisted of all patients in the safety population who had both a baseline tumor assessment and at least one post-baseline tumor assessment. Patients were included in the analysis according to the dose of IMP received.|||Patients|||Number
2624306|NCT01924689|Secondary|Positive Blood Cultures-Number of Patients With Presence of C. Novyi-NT|To study the presence of circulating C. novyi-NT spores after administration as a single IT injection to humans with treatment-refractory solid tumor malignancies.|At Screening, at Days -1 to 0, at Days 1, 2, 3, 4, 5, 7, at follow up (at 2 months (±2 days) after dosing)|"The safety data set included all patients who received any amount of C. novyi-NT, the IMP. Patients were included in the safety analysis according to the dose of IMP received.~Note: Two patients had positive C.novyi culture at Screening due to contamination, and one patient in Cohort 4 had positive C. novyi culture on Day 3 due to contamination."|||Patients|||Number
2624307|NCT01924689|Secondary|Number of Patients With Overall RECIST Response|To document preliminary anti-tumor activity of an overall response after administering a single IT injection of C. novyi-NT in humans with treatment-refractory solid tumor malignancies. The evaluation of anti-tumor activity included an overall response.|At follow up (at 1 and 2, 4, and 8 months (±2 days) after dosing)|The efficacy data set or full analysis set consisted of all patients in the safety population who had both a baseline tumor assessment and at least one post-baseline tumor assessment. Patients were included in the analysis according to the dose of IMP received.|||Patients|||Number
2624308|NCT01924689|Secondary|Number of Patients With RECIST Assessment on the Injected Lesion|"To document preliminary anti-tumor activity of the injected lesion after administering a single IT injection of C. novyi-NT in humans with treatment-refractory solid tumor malignancies. The evaluation of anti-tumor activity included a response for the injected lesion.~Response and progression was evaluated using the international criteria proposed by the RECIST 1.1. Objective responses were measured by serial CT or MRI scans of the injected lesion and sites of metastatic involvement. Overall response, based on CT/MRI scan results, was based on observation of measurable and non-measurable disease as compared to baseline and nadir in target and non-target tumors per RECIST 1.1."|At follow up (at 1 and 2, 4, and 8 months (±2 days) after dosing)|The efficacy data set or full analysis set consisted of all patients in the safety population who had both a baseline tumor assessment and at least one post-baseline tumor assessment. Patients were included in the analysis according to the dose of IMP received.|||Patients|||Number
2624309|NCT01924689|Secondary|Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans|"To document preliminary anti-tumor activity of the injected lesion after administering a single IT injection of C. novyi-NT in humans with treatment-refractory solid tumor malignancies. Response and progression was evaluated using the international criteria proposed by the RECIST 1.1. Objective responses were measured by serial CT or MRI scans of the injected lesion and sites of metastatic involvement. Overall response, based on CT/MRI scan results, was based on observation of measurable and non-measurable disease as compared to baseline and nadir in target and non-target tumors per RECIST 1.1.~Change from baseline is presented."|At screening, at follow up (at 1, 2, 4, and 8 months (±2 days) after dosing)|The efficacy data set or full analysis set consisted of all patients in the safety population who had both a baseline tumor assessment and at least one post-baseline tumor assessment. Patients were included in the analysis according to the dose of IMP received.|||Percentage of change|||Number
2624310|NCT01924689|Primary|Number of Patients With Adverse Events Qualified as Dose Limiting Toxicities (DLTs)|To determine the DLTs of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when administered as a single IT injection.|From screening until follow-up visit (up to 12 months)|The safety data set included all patients who received any amount of C. novyi-NT, IMP. Patients were included in the safety analysis according to the dose of IMP received.|||Patients|||Number
2624311|NCT01924689|Primary|Number of Patients With Treatment-emergent Adverse Events (TEAE)|"To determine the safety profile of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when administered as a single IT injection.~CTCAE: Common Terminology Criteria for Adverse Events"|From screening until follow-up visit (up to 12 months)|The safety data set included all patients who received any amount of C. novyi-NT, the investigational medicinal product (IMP). Patients were included in the safety analysis according to the dose of IMP received.|||Patients|||Number
2624312|NCT01924559|Primary|Time to Successful Intubation|Time from initiation of intubation attempt to successful 2 breaths demonstrating lung expansion, estimated less than 1 minute|approximately one minute|EM Residents who tested/participated in each of the six groups|||seconds||Full Range|Mean
2624313|NCT01924533|Secondary|Duration of Response|Time from the first documentation of CR/PR until the date of progression, or the last evaluable RECIST assessment for patients taht do not progress or progress after two or more missed visits|Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years|Patients with objective response in full analysis set ATM negative population|||days||Inter-Quartile Range|Median
2624314|NCT01924533|Secondary|Duration of Response|Time from the first documentation of CR/PR until the date of progression, or the last evaluable RECIST assessment for patients taht do not progress or progress after two or more missed visits|Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years|Patients with objective response in full analysis set population|||days||Inter-Quartile Range|Median
2624315|NCT01924533|Secondary|Time to Response|Time from randomization to the first onset of a confirmed objective tumour response|Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years|Patients with objective response in full analysis set ATM negative population|||days||Inter-Quartile Range|Median
2625994|NCT01906866|Secondary|The Duration of Wake After Sleep Onset Period Will be Measured for the Circadin 2/5 mg and Placebo by a Sleep and Nap Diary After 13 Weeks of Double-blind Treatment.|Questionnaire|up to 1.5 years|||||||
2624317|NCT01924533|Secondary|Number of Patients With Deterioration of Health Related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Questionnaire Core 30 Item Module (QLQ-C30) Global HRQoL Scale|Number of patients with a clinically important deterioration in the global HRQoL score or death by any cause in the absence of a clincially meaningful symptom deterioration|Pre-treatment , Day 29 and then every 4 weeks until discontinuation, assessed up to 3 years|Patients whose baseline HRQoL score >=10 in full analysis set ATM negative population|||participants|||Number
2624318|NCT01924533|Secondary|Number of Patients With Deterioration of Health Related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Questionnaire Core 30 Item Module (QLQ-C30) Global HRQoL Scale|Number of patients with a clinically important deterioration in the global HRQoL score or death by any cause in the absence of a clincially meaningful symptom deterioration|Pre-treatment , Day 29 and then every 4 weeks until discontinuation, assessed up to 3 years|Patients whose baseline HRQoL score >=10 in full analysis set population|||participants|||Number
2624319|NCT01924533|Secondary|Number of Patients Objective Response|Number of patients with objective response. Per RECIST 1.1, complete response (CR) is disappearance of all target lesions since baseline; partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Overall Response = CR + PR.|Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years|Full analysis set - ATM negative population|||participants|||Number
2624320|NCT01924533|Secondary|Number of Patients With Objective Response.|Number of patients with objective response. Per RECIST 1.1, complete response (CR) is disappearance of all target lesions since baseline; partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Overall Response = CR + PR.|Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years|Full analysis set population|||participants|||Number
2624321|NCT01924533|Secondary|Progression-Free Survival (PFS)|Time from randomization until the date of objective radiological disease progression according to RECIST (v1.1) or death by any cause in the absence of progression. Objective progression is defined as at least a 20% increase in the sum of the diameters of the target lesions (compared to previous minimum sum) or an overall non-target lesion assessment of progression or a new lesion.|Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years|FAS analysis set - ATM negative population|||participants|||Number
2624322|NCT01924533|Secondary|Progression-Free Survival (PFS)|Time from randomization until the date of objective radiological disease progression according to RECIST (v1.1) or death by any cause in the absence of progression. Objective progression is defined as at least a 20% increase in the sum of the diameters of the target lesions (compared to previous minimum sum) or an overall non-target lesion assessment of progression or a new lesion.|Scans taken at baseline and then follow up assessments taken every 8 weeks up to Week 40 and then every 16 weeks until objective disease progression as defined by RECIST 1.1, assessed up to 3 years|FAS analysis set population|||participants|||Number
2624323|NCT01924533|Primary|Overall Survival|Time from the date of randomization until death due to any cause|Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years|Full analysis set - ATM negative population|||participants|||Number
2624324|NCT01924533|Primary|Overall Survival|Time from the date of randomization until death due to any cause|Survival contact from the date of randomization and then every 8 weeks following objective disease progression and in the 7 days following OS Data Cut off (DCO); Time point(s) at which outcome measure is assessed up to 4 years|Full analysis set population|||participants|||Number
2624325|NCT01924442|Secondary|Long-term Major Adverse Cardiovascular Event (MACE) Between On-pump and Off-pump Patients|Secondary outcomes included the 5-year rates of death from cardiac causes, repeat revascularization and nonfatal myocardial infarction.|5 years||||Participants|||Count of Participants
2624326|NCT01924442|Primary|Long-term All Cause Mortality Between On-pump and Off-pump Patients.|Five-year mortality was initially assessed by matching the participants in the follow-up study to data in the VA Vital Status File and the National Death Index, which provided cause-of-death codes according to the International Classification of Diseases, 10th Revision.|5 Years||||Participants|||Count of Participants
2624327|NCT01924429|Secondary|CGI-S|"CGI-S: Severity of impairment due to ADHD was measured by the Clinical Global Impressions-Severity scale (CGI-S). Lower scores indicate less severe impairment from symptoms, with a CGI-I=1 indicating the person is normal with no impairment. (1= normal, not ill, 2= minimally ill, 3= mildly ill, 4= moderately ill, 5=markedly ill, 6=severely ill, 7= very severely ill)"|baseline||||units on a scale||Standard Deviation|Mean
2624328|NCT01924429|Secondary|CGI-I|Clinical Global Impressions - CGI-I: Clinical response was the Clinical Global Impression-Improvement scale (CGI-I). Lower CGI-I scores indicate greater improvement (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse).|Baseline||||units on a scale||Standard Deviation|Mean
2624329|NCT01924429|Secondary|ADHD-Inattentive|ADHD symptoms and severity - subscale for Inattentiveness. 9-item scale, each scored 0-3, with total from 0 to 27. Higher score indicates higher level of inattentiveness.|4 weeks and 8 weeks||||units on a scale||Standard Deviation|Mean
2624330|NCT01924429|Secondary|ADHD-RS-IV Combined Sum|ADHD symptoms and severity. Norm referenced interview to assess severity and frequency of ADHD symptoms. 18 Items are scored 0-3 to reflect severity and frequency of ADHD symptoms, and a sum is taken. Full range from 0 to 54, with higher number indicating more symptoms and severity.|Baseline||||units on a scale||Standard Deviation|Mean
2624331|NCT01924429|Secondary|WRAADS|"The Wender-Reimherr adult attention deficit disorder scale (WRAADS): Symptom measure for emotional functioning/lability, generally reported as Sum of Responses (0-2 per item, higher = more impaired).~For this outcome measure, Average scores for particular questions were taken - specifically question 3, question 4, and question 5."|Baseline||||units on a scale||Standard Deviation|Mean
2624334|NCT01924429|Secondary|ASRS - Expanded|ADHD and Related Symptoms Measure (ASRS): self report, reported as Sum of Responses (0-4 per item, higher = more impaired) 0-26 (normal range) and >27 (clinically significant symptoms).|Baseline||||units on a scale||Standard Deviation|Mean
2624335|NCT01924429|Secondary|BRIEF-A|Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (higher is worse)|at 4 weeks|not collected||||||
2624336|NCT01924429|Secondary|BRIEF-A|Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (higher is worse)|at one week|not collected||||||
2624337|NCT01924429|Secondary|BRIEF-A|Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (0 to 100, with 50 +/-1 SD = 'Normal', higher is worse, more impaired)|Baseline||||t-score||Standard Deviation|Mean
2624338|NCT01924429|Primary|fMRI Reaction Time|Reaction-time, as measured by the reaction time test Go/No-Go Task as a Function of Trial Type, Face Emotion, and Drug Condition in Adults with Attention-Deficit/Hyperactivity Disorder|up to 6 weeks||||ms||Standard Error|Mean
2624339|NCT01924429|Primary|The Go/No-Go Task Percentage Assessed by fMRI|"Performance Measures on the Go/No-Go Task assessed by fMRI as a Function of Trial Type, Face Emotion, and Drug Condition in Adults with Attention-Deficit/Hyperactivity Disorder. The Go/No-Go Task is a neuropsychological test that provides a direct measure of number of responses made that are correct or incorrect. It is not a scale. Reported are the percentage of correct responses on that direct performance measure. 0% correct is worse than 100% correct."|8 weeks|Performance measures are done while participants are off drug and while on drug.|||percentage correct responses/inhibitions||Standard Error|Mean
2624340|NCT01924390|Other Pre-specified|Change in Ridge Width and Ridge Height|Ridge width and height are measured at time of tooth extraction & grafting, and again 18-20 weeks later at time of implant placement. Changes in ridge height and width are determined.|At time of implant placement, which is 18-20 weeks after grafting of extraction socket||||change in ridge width (loss of width mm)||Standard Deviation|Mean
2624341|NCT01924390|Secondary|Percent Residual Graft Material and Percent Connective Tissue|Bone core biopsy will be evaluated histologically for percent residual bone graft material and percent connective tissue|18-20 weeks||||percentage of residual graft||Standard Deviation|Mean
2624342|NCT01924390|Primary|Percent New Vital Bone Formation|Bone core biopsy will be evaluated histologically for percent new vital bone formation|18-20 weeks||||percentage of vital bone||Standard Deviation|Mean
2624343|NCT01924364|Secondary|Adipose Stem Cell Yield Per Volume of Fat Tissue|this describes the biologic properties of the cells within the fat graft|Surgical visit||||%age of cells yield/volume of fat tissue||Standard Deviation|Mean
2624344|NCT01924364|Primary|Total Fat Volume Injected and Facial Volume Postop|Facial appearance and persistence of treatment effect will be assessed using high resolution CT scanning with 3D reconstruction. Patients will be followed for 24 months after treatment to define long term outcomes.|Surgical visit, PO Study visits month 3, month 9, month 12, and month 24||||mL||Standard Deviation|Mean
2624345|NCT01924299|Primary|PK: Tmax of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole||Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + fluconazole in Period 2) and had PK data to calculate Tmax of baricitinib.|||hours||Full Range|Median
2624346|NCT01924299|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole||Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ketoconazole in Period 2) and had PK data to calculate Tmax of baricitinib.|||hours||Full Range|Median
2624347|NCT01924299|Primary|PK: Cmax of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole||Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + fluconazole in Period 2) and had PK data to calculate Cmax of baricitinib.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2624348|NCT01924299|Primary|PK: Maximum Concentration (Cmax) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole||Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ketoconazole in Period 2) and had PK data to calculate Cmax of baricitinib.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2624349|NCT01924299|Primary|PK: AUC(0-∞) of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Fluconazole||Days 1 and 7: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + fluconazole in Period 2) and had PK data to calculate AUC(0-∞) of baricitinib.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2624350|NCT01924299|Primary|Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Baricitinib Following Single Doses of Baricitinib Alone or Coadministered With Ketoconazole||Days 1 and 6: predose of baricitinib and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24 and 48 hours postdose|All enrolled participants who received study drug (baricitinib in Period 1 and baricitinib + ketoconazole in Period 2) and had PK data to calculate AUC(0-∞) of baricitinib.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2624365|NCT01923805|Primary|Transfusion Requirements|The primary objective of this study is to test for significant differences in transfusion requirements in patients managed with RTKA.|Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.|Data were not collected from participants enrolled in the study||||||
2624366|NCT01923740|Secondary|Distal Late Loss (LL)|"Distal Late Loss calculated as Distal MLD post procedure - Distal MLD at followup.~Distal is defined as within 5 mm of healthy tissue distal to the device placement."|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter|Target lesions|Standard Deviation|Mean
2624351|NCT01924182|Other Pre-specified|Sleep Assessment|Compare changes from Baseline to Month 3 between the IT group and CMM group for Apnea-Hypopnea Index (AHI). The AHI was collected via overnight sleep lab polysomnography. The AHI is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The AHI values for adults are categorized as Normal: AHI<5, Mild sleep apnea: 5≤AHI<15, Moderate sleep apnea: 15≤AHI<30, Severe sleep apnea: AHI≥30. For each subject, the change in AHI will be calculated as the AHI at Month 3 minus the AHI at Baseline. A negative change value represents a lowering of the subjects AHI (an improvement, or reduction in sleep apnea).|3 Month|2 of the 3 randomized participants did not complete the follow-up or provide outcome information. As there was only 1 participant that completed the outcome assessment, no statistical analysis will be presented.|||units on a scale||Standard Deviation|Mean
2624352|NCT01924182|Secondary|Opioid-Related Side Effects|Summarize the changes from Baseline to Month 3 between the IT group and CMM group in Common Terminology Criteria for Adverse Events (CTCAE) toxicity score. (from the National Cancer Institute) A subset of 23 specific items of the CTCAE v4.03 were evaluated. The subset was chosen as these criteria were most related to opioid side effects that are of interest in this study. The investigator scored the assessment at each visit. The total score for a visit is based on the sum of 23 individual CTCAE's. The individual scales have a range of 0 to 2, 0 to 3, or 0 to 5 and the total score ranges from 0 (best case) to 90 (worst case). For each subject, the change in toxicity will be calculated as the total toxicity score at Month 3 minus the total toxicity score at Baseline. A negative change value represents a lowering of the subjects toxicity score (an improvement, or reduction in toxicity).|3 Month|2 of the 3 randomized participants did not complete the follow-up or provide outcome information. As there was only 1 participant that completed the secondary outcome assessment, no statistical analysis will be presented.|||units on a scale||Standard Deviation|Mean
2624353|NCT01924182|Secondary|Pain Assessment|Compare changes from Baseline to Month 3 between the IT group and CMM group in Numeric Pain Rating Scale (NPRS). The scale measures pain intensity. Using NPRS, a pain score ranging from 0 (no pain) to 10 (pain as bad as you can imagine) is recorded on a subject diary twice daily for 5 days before a study visit. The score for each visit is calculated as the mean pain of the 5 diary days morning and evening scores. For each subject, the change in pain will be calculated as the mean pain score at Month 3 minus the mean pain score at Baseline. A negative change value represents a lowering of the pain score (an improvement, or reduction in pain).|3 Month|2 of the 3 randomized participants did not complete the follow-up or provide outcome information. As there was only 1 participant that completed the secondary outcome assessment, no statistical analysis will be presented.|||units on a scale||Standard Deviation|Mean
2624354|NCT01924182|Primary|Clinical Success|Determine the proportion of subjects with clinical success based on changes in pain intensity (Numerical Pain Rating Scale: NPRS) and opioid-related Common Toxicity Criteria for Adverse Events (CTCAE) from the National Cancer Institute (NCI).|3 Month|2 of the 3 randomized participants did not complete the follow-up or provide outcome information. As there was only 1 participant that completed the primary outcome assessment, no statistical analysis will be presented.|||participants|||Number
2624355|NCT01924169|Secondary|Seroconversion Response|Study considered positive in regard to the secondary endpoints if seroconversion is observed in 60% or more of the subjects for at least one of the vaccinations given.|4 weeks after flu vaccine administered|The first three participants did not remain on study long enough to undergo immunizations.||||||
2624356|NCT01924169|Primary|Number of Participants With IgG Response|IgG response defined as having improvement in IgG level by at least 25% at 6 months, compared to baseline.|6 months||||Participants|||Count of Participants
2624357|NCT01923961|Secondary|Hemocompatibility|Maximum free hemoglobin in plasma, which indicates hemolysis. Hemoglobin is released into plasma in case of red blood cell destruction.|4 hours|Per protocol analysis|||percentage of total hemoglobin||Standard Deviation|Mean
2624358|NCT01923961|Secondary|Plasma Sodium Concentrations|Maximum arterial sodium concentrations|4 hours|Per protocol analysis|||mval/l||Standard Deviation|Mean
2624359|NCT01923961|Primary|Removal of Indoxylsulfate|Determination of the reduction ratio, which is the ratio of a solute concentration in plasma at baseline and at the end of the intervention|4 hours|Per protocol analysis|||percentage of reduction||Standard Deviation|Mean
2624360|NCT01923961|Primary|Removal of Para-cresylsulfate|Determination of reduction ratio, which is the ratio of a solute concentration in plasma at baseline and at the end of the intervention|4 hours|Per protocol population|||percentage of reduction||Standard Deviation|Mean
2624361|NCT01923896|Primary|Disruptions|Disruptions were defined as turning the head 45 degrees away from the spoon and/or pushing away the spoon or feeder's hand/arm during the bite presentation. Converted counts of each variable into percentages by dividing the total occurrence of a target behavior during a meal by the total number of bites presented per meal|Mealtime behavior (disruptions) at meal 13||||percentage of inappropriate behaviors||Inter-Quartile Range|Median
2624362|NCT01923896|Primary|Disruptions|Disruptions were defined as turning the head 45 degrees away from the spoon and/or pushing away the spoon or feeder's hand/arm during the bite presentation. Converted counts of each variable into percentages by dividing the total occurrence of a target behavior during a meal by the total number of bites presented per meal|Mealtime behavior (disruptions) at meal 1||||percentage of inappropriate behaviors||Inter-Quartile Range|Median
2624363|NCT01923896|Primary|Rapid Swallowing|Rapid swallowing was scored if the child swallowed the entire bolus within 30 seconds after the feeder deposited the bite. This was visually confirmed by the feeder using a three-step prompting sequence (i.e., verbal: ''show me''; gestural: ''show me like this'' plus modeling opening the mouth; physical: ''show me'' plus gentle pressure applied to the side of the teeth with a baby spoon).|Mealtime behavior (swallowing) at meal 13|All subjects completed up to meal 13.|||percentage of bites||Inter-Quartile Range|Median
2624364|NCT01923896|Primary|Rapid Swallowing|Rapid swallowing was scored if the child swallowed the entire bolus within 30 seconds after the feeder deposited the bite. This was visually confirmed by the feeder using a three-step prompting sequence (i.e., verbal: ''show me''; gestural: ''show me like this'' plus modeling opening the mouth; physical: ''show me'' plus gentle pressure applied to the side of the teeth with a baby spoon).|Mealtime behavior (swallowing) at meal 1||||percentage of bites||Inter-Quartile Range|Median
2624367|NCT01923740|Secondary|Proximal Late Loss (LL)|"Proximal Late Loss: Proximal MLD post procedure - Proximal MLD at followup.~Proximal is defined as within 5 mm of healthy tissue proximal to the device placement."|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter|Target lesions|Standard Deviation|Mean
2624368|NCT01923740|Secondary|In-Device Late Loss (LL)|In-device late loss is calculated as (in-device MLD post-procedure) - (in-device MLD at followup).|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter|Target lesions|Standard Deviation|Mean
2624369|NCT01923740|Secondary|Percentage of Participants With Distal Angiographic Binary Restenosis (ABR)|Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Percentage of participants|Target lesions||Number
2624370|NCT01923740|Secondary|In-Segment Late Loss (LL)|In-segment Late Loss is calculated as (in-segment MLD post-procedure) - (in-segment MLD at followup).|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter|Target lesions|Standard Deviation|Mean
2624371|NCT01923740|Secondary|Percentage of Participants With In-Device Angiographic Binary Restenosis (ABR)|Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Percentage of participants|Target lesions||Number
2624372|NCT01923740|Secondary|Percentage of Participants With In-Segment Angiographic Binary Restenosis (ABR)|Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%. InSegment is defined as within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent.|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||percentage of participants|Target lesions||Number
2624373|NCT01923740|Secondary|Distal Percent Diameter Stenosis (%DS)|"The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).~Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method."|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Percent Diameter stenosis|Target lesions|Standard Deviation|Mean
2624374|NCT01923740|Secondary|Percentage of Participants With Proximal Angiographic Binary Restenosis (ABR)|Angiographic Binary Restenosis (ABR): Renarrowing of the artery defined as %DS ≥ 50%.|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Percentage of participants|Target lesions||Number
2624375|NCT01923740|Secondary|Proximal Percent Diameter Stenosis (%DS)|"The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).~Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method."|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Percent Diameter stenosis|Target lesions|Standard Deviation|Mean
2624376|NCT01923740|Secondary|In-Device Percent Diameter Stenosis (%DS)|"The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).~Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method."|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Percent Diameter stenosis|Target lesions|Standard Deviation|Mean
2624377|NCT01923740|Secondary|In-Segment Percent Diameter Stenosis (%DS)|The Percent Diameter Stenosis value calculated as 100 * (1 MLD/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). Reference vessel diameter based on QCA is derived from either the user defined method using average diameter of proximal and distal healthy segments or the interpolated method.|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Percent Diameter stenosis|Target lesions|Standard Deviation|Mean
2624378|NCT01923740|Secondary|Distal Minimum Lumen Diameter (MLD)|Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter|Target lesions|Standard Deviation|Mean
2624379|NCT01923740|Secondary|Proximal Minimum Lumen Diameter (MLD)|Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.|1 year|Per-Treatment-Evaluable Population (PTE) Population. Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter|Target lesions|Standard Deviation|Mean
2624380|NCT01923740|Secondary|In-Segment Minimum Lumen Diameter (MLD)|"Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.~INSEGMENT: Within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent."|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter|Target lesions|Standard Deviation|Mean
2624381|NCT01923740|Secondary|In-Device Minimum Lumen Diameter (MLD)|Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. Data are collected from two projections.|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter|Target lesions|Standard Deviation|Mean
2624397|NCT01923740|Secondary|Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624382|NCT01923740|Secondary|Over All Number of Participants With Cumulative 5 Year Stent /Scaffold Thrombosis|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|0-1825 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2624383|NCT01923740|Secondary|Number of Participants With Very Late 3 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|1096-1825 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2624384|NCT01923740|Secondary|Number of Participants With Very Late 4 to 5 Year Stent/Scaffold Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|1461-1825 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2624385|NCT01923740|Secondary|Number of Participants With Very Late 3 to 4 Year Stent/Scaffold Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|1096-1460 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2624386|NCT01923740|Secondary|Number of Participants With Very Late 1 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|366-1095 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2624387|NCT01923740|Secondary|Number of Participants With Very Late 2 to 3 Year Stent/Scaffold Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|731 to 1095 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2624388|NCT01923740|Secondary|Number of Participants With Very Late 1 to 2 Year Stent/Scaffold Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|366 to 730 days|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2624389|NCT01923740|Secondary|Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|31 to 365 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624390|NCT01923740|Secondary|Number of Participants With Subacute Stent/Scaffold Thrombosis (Per ARC Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|>1 to 30 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624391|NCT01923740|Secondary|Number of Participants With Acute Stent/Scaffold Thrombosis (Per Academic Research Consortium (ARC) Definition)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|< or = 1 day|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624392|NCT01923740|Secondary|Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|5 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624393|NCT01923740|Secondary|Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|4 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624394|NCT01923740|Secondary|Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|3 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624395|NCT01923740|Secondary|Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|2 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up..|||Participants|||Count of Participants
2624396|NCT01923740|Secondary|Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624455|NCT01923740|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"Ischemia-driven TVR (ID-TVR)~Not ischemia-driven TVR (NID-TVR)"|5 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624398|NCT01923740|Secondary|Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624399|NCT01923740|Secondary|Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).|0 to 37 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624400|NCT01923740|Secondary|Number of Participants With Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Event [MACE])|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and Ischemic driven target lesion revascularization (ID-TLR).|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624401|NCT01923740|Secondary|Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|5 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624402|NCT01923740|Secondary|Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|4 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up..|||Participants|||Count of Participants
2624403|NCT01923740|Secondary|Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|3 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624404|NCT01923740|Secondary|Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|2 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624405|NCT01923740|Secondary|Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624406|NCT01923740|Secondary|Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624407|NCT01923740|Secondary|Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624408|NCT01923740|Secondary|Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 37 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624409|NCT01923740|Secondary|Number of Participants With Cardiac Death/All MI/ID-TVR [Target Vessel Failure (TVF)]|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|≤ 7 days post index procedure (In-hospital)|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624410|NCT01923740|Secondary|Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|5 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624411|NCT01923740|Secondary|Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|4 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624412|NCT01923740|Secondary|Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|3 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624413|NCT01923740|Secondary|Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|2 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624456|NCT01923740|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"Ischemia-driven TVR (ID-TVR)~Not ischemia-driven TVR (NID-TVR)"|4 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624414|NCT01923740|Secondary|Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624415|NCT01923740|Secondary|Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624416|NCT01923740|Secondary|Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624417|NCT01923740|Secondary|Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|0 to 37 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624418|NCT01923740|Secondary|Number of Participants With Cardiac Death/TV-MI/ID-TLR [Target Lesion Failure (TLF)]|Target lesion failure (TLF) composite of Cardiac Death, Myocardial Infarction attributable to Target Vessel (TV-MI), or Ischemia-Driven Target Lesion Revascularization (ID-TLR))|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624419|NCT01923740|Secondary|Number of Participants With All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|5 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624420|NCT01923740|Secondary|Number of Participants With All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|4 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624421|NCT01923740|Secondary|Number of Participants With All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|3 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up..|||Participants|||Count of Participants
2624422|NCT01923740|Secondary|Number of Participants With All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|2 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624423|NCT01923740|Secondary|Number of Participants With All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624424|NCT01923740|Secondary|Number of Participants With All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624425|NCT01923740|Secondary|Number of Participants With All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624426|NCT01923740|Secondary|Number of Participants With All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|0 to 37 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624427|NCT01923740|Secondary|Number of Participants With All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624428|NCT01923740|Secondary|Number of Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment|5 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624429|NCT01923740|Secondary|Number of Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|4 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624430|NCT01923740|Secondary|Number of Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|3 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624431|NCT01923740|Secondary|Number of Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|2 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624432|NCT01923740|Secondary|Number of Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624433|NCT01923740|Secondary|Number of Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624434|NCT01923740|Secondary|Number of Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624435|NCT01923740|Secondary|Number of Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|0 to 37 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624436|NCT01923740|Secondary|Number of Cardiac Death/All MI|Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624437|NCT01923740|Secondary|Number of Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|5 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624438|NCT01923740|Secondary|Number of Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|4 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624439|NCT01923740|Secondary|Number of Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|3 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624440|NCT01923740|Secondary|Number of Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|2 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624441|NCT01923740|Secondary|Number of Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624457|NCT01923740|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"Ischemia-driven TVR (ID-TVR)~Not ischemia-driven TVR (NID-TVR)"|3 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624442|NCT01923740|Secondary|Number of Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624443|NCT01923740|Secondary|Number of Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624444|NCT01923740|Secondary|Number of Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 37 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624445|NCT01923740|Secondary|Number of Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624446|NCT01923740|Secondary|Number of Participants With All Coronary Revascularization (PCI and CABG)|All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)|5 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624447|NCT01923740|Secondary|Number of Participants With All Coronary Revascularization (PCI and CABG)|All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)|4 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624448|NCT01923740|Secondary|Number of Participants With All Coronary Revascularization (PCI and CABG)|All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)|3 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624449|NCT01923740|Secondary|Number of Participants With All Coronary Revascularization (PCI and CABG)|All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)|2 year|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2624450|NCT01923740|Secondary|Number of Participants With All Coronary Revascularization (PCI and CABG)|All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624451|NCT01923740|Secondary|Number of Participants With All Coronary Revascularization (PCI and CABG)|All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)|0 to 298 Days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624452|NCT01923740|Secondary|Number of Participants With All Coronary Revascularization (PCI and CABG)|All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624453|NCT01923740|Secondary|Number of Participants With All Coronary Revascularization (PCI and CABG)|All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)|0 to 37days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624454|NCT01923740|Secondary|Number of Participants With All Coronary Revascularization (PCI and CABG)|All coronary revascularization includes percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG)|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624498|NCT01923480|Secondary|Plasma Concentration of Taurine||Three times during each 7 hour visit|No data available as no data for this outcome measure were collected during the study.||||||
2624458|NCT01923740|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"Ischemia-driven TVR (ID-TVR)~Not ischemia-driven TVR (NID-TVR)"|2 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624459|NCT01923740|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"Ischemia-driven TVR (ID-TVR)~Not ischemia-driven TVR (NID-TVR)"|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624460|NCT01923740|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"Ischemia-driven TVR (ID-TVR)~Not ischemia-driven TVR (NID-TVR)"|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624461|NCT01923740|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"Ischemia-driven TVR (ID-TVR)~Not ischemia-driven TVR (NID-TVR)"|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624462|NCT01923740|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"Ischemia-driven TVR (ID-TVR)~Not ischemia-driven TVR (NID-TVR)"|0 to 37 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624463|NCT01923740|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|"Ischemia-driven TVR (ID-TVR)~Not ischemia-driven TVR (NID-TVR)"|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624464|NCT01923740|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Ischemia-driven TLR (ID-TLR)~Not ischemia-driven TLR (NID-TLR)"|5 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624465|NCT01923740|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Ischemia-driven TLR (ID-TLR)~Not ischemia-driven TLR (NID-TLR)"|4 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624466|NCT01923740|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Ischemia-driven TLR (ID-TLR)~Not ischemia-driven TLR (NID-TLR)"|3 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up..|||Participants|||Count of Participants
2624467|NCT01923740|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Ischemia-driven TLR (ID-TLR)~Not ischemia-driven TLR (NID-TLR)"|2 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624468|NCT01923740|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Ischemia-driven TLR (ID-TLR)~Not ischemia-driven TLR (NID-TLR)"|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624469|NCT01923740|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Ischemia-driven TLR (ID-TLR)~Not ischemia-driven TLR (NID-TLR)"|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624470|NCT01923740|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Ischemia-driven TLR (ID-TLR)~Not ischemia-driven TLR (NID-TLR)"|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624471|NCT01923740|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Ischemia-driven TLR (ID-TLR)~Not ischemia-driven TLR (NID-TLR)"|0 to 37 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624472|NCT01923740|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Ischemia-driven TLR (ID-TLR)~Not ischemia-driven TLR (NID-TLR)"|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624473|NCT01923740|Secondary|Number of Participants With Myocardial Infarction|MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.|5 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624474|NCT01923740|Secondary|Number of Participants With Myocardial Infarction|MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.|4 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624475|NCT01923740|Secondary|Number of Participants With Myocardial Infarction|MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.|3 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624476|NCT01923740|Secondary|Number of Participants With Myocardial Infarction|MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.|2 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624477|NCT01923740|Secondary|Number of Participants With Myocardial Infarction|MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624478|NCT01923740|Secondary|Number of Participants With Myocardial Infarction|MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624479|NCT01923740|Secondary|Number of Participants With Myocardial Infarction|MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624480|NCT01923740|Secondary|Number of Participants With Myocardial Infarction|MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.|0 to 37 days|Per-Treatment-Evaluable Population. Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624481|NCT01923740|Secondary|Number of Participants With Myocardial Infarction|MI was categorized as Q-wave MI (QMI) and non-Q-wave MI (NQMI) and also MI attributable to target vessel (TV-MI) and MI not attributable to target vessel (NTV-MI). In addition, MIs were adjudicated based on three different MI definitions (per-protocol, modified ARC and WHO definitions) with the per-protocol analysis being the primary analysis for the study.|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624482|NCT01923740|Secondary|Number of Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma"|5 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624483|NCT01923740|Secondary|Number of Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|4 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624484|NCT01923740|Secondary|Number of Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|3 years|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624485|NCT01923740|Secondary|Number of Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|2 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624486|NCT01923740|Secondary|Number of Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624499|NCT01923480|Secondary|Plasma Concentration of Serine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
2624500|NCT01923480|Secondary|Plasma Concentration of Proline||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
2624487|NCT01923740|Secondary|Number of Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 298 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624488|NCT01923740|Secondary|Number of Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 208 days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624489|NCT01923740|Secondary|Number of Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 37days|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624490|NCT01923740|Secondary|Number of Death (Cardiac, Vascular, Non-cardiovascular)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|≤ 7 days post index procedure (In-hospital )|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Participants|||Count of Participants
2624491|NCT01923740|Secondary|Number of Participants With Acute Procedural Success|"Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days). In dual target lesion setting, both lesions must meet clinical procedure success criteria to have a patient level procedure success.~Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population (PTE) analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only."|At time of procedure up to 7 days in hospital|ITT set. Four subjects (Absorb BVS (1) arm and XIENCE V arm (3)) were excluded from the data analysis for acute success. During the index procedure, 5 subjects withdrew consent following randomization and before any device attempts. Data from these 5 subjects (3 in the Absorb BVS arm and 2 in the XIENCE V arm) were excluded from all data analyses.|||Participants|||Count of Participants
2624492|NCT01923740|Secondary|Acute Device Success|"Successful delivery and deployment of the assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final inscaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.~Acute success (device success and procedure success) was determined based on the device randomized while the Per-Treatment-Evaluable Population analysis must be based on the device actually received. Hence, device success and procedure success were provided for the ITT population only."|< or = 1 day|"Intent to treat set (ITT). Four subjects (1 in the Absorb BVS arm and 3 in the XIENCE V arm) were excluded from the data analysis for acute success.~During the index procedure, 5 subjects withdrew consent following randomization and before any device attempts,3 in the Absorb BVS arm and 2 in the XIENCE V arm were excluded from all data analyses."|||Percentage of target lesions|Target lesions||Number
2624493|NCT01923740|Primary|In-segment Late Loss (LL) - Per Lesion Analysis|In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter|Target lesions|Standard Deviation|Mean
2624494|NCT01923740|Primary|In-segment Late Loss (LL) - Per Subject Analysis|In-segment late loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent from post-procedure to 1 year by angiography.|1 year|Per-Treatment Evaluable Population set (PTE). Analysis population exclude subjects who are truly lost-to-follow-up.|||Millimeter||Standard Deviation|Mean
2624495|NCT01923480|Secondary|Plasma Concentration of Valine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
2624496|NCT01923480|Secondary|Plasma Concentration of Tyrosine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
2624497|NCT01923480|Secondary|Plasma Concentration of Threonine||Three times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||micromol/L||Standard Deviation|Mean
2624514|NCT01923480|Secondary|Plasma Stable Isotope Enrichment of Tyrosine||Twelve times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2. During both periods (1 and 2), samples were not obtained from any subjects at the 0hr time point.|||trace/tracee ratio||Standard Deviation|Mean
2624515|NCT01923480|Secondary|Plasma Stable Isotope Enrichment of Phenylalanine||Twelve times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2. During both periods (1 and 2), samples were not obtained from any subjects at the 0hr time point.|||trace/tracee ratio||Standard Deviation|Mean
2624516|NCT01923480|Secondary|Serum Concentration of Insulin||Five times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2. One subject in grp 0.04 g/kg/hr, seq BA, serum concentration of insulin was not collected at any time point during Period 1. One subject in grp 0.08 g/kg/hr, seq AB, serum concentration of insulin was not collected at the 3hr time point during Period 2.|||mciu/mL||Standard Deviation|Mean
2624517|NCT01923480|Secondary|Plasma Concentration of Glucose||Nine times during each 7 hour visit|One subject completed Period 1, but withdrew from the study prior to the start of Period 2. One subject in grp 0.04 g/kg/hr, seq BA, plasma concentration of glucose was not collected at any time point during Period 1.|||mg/dL||Standard Deviation|Mean
2624518|NCT01923480|Secondary|Insulin Sensitivity||Five times during each 7 hour visit|No data available as no data for this outcome measure were collected during the study.||||||
2624519|NCT01923480|Primary|Change in Net Protein Synthesis||One time at pre-clinisol infusion and one time at post-clinisol infusion|One subject completed Period 1, but withdrew from the study prior to the start of Period 2.|||g protein/d/kg ffm||Standard Deviation|Mean
2624520|NCT01923467|Primary|Acceptance of Offer to Join Stop Smoking Program|After participation in online image viewing and writing reflection tasks, participants will be asked if they would like to take part in an online stop-smoking program.|1 Day of Enrollment||||participants|||Number
2624521|NCT01923428|Primary|Percent Complete Spontaneous Bowel Movement Responders vs Placebo|Weekly complete spontaneous bowel movement resaponders defined as an increase of one or more bowel movement per week from baseline for 6 of the 12 weeks|12 weeks||||Participants|||Count of Participants
2624522|NCT01923389|Secondary|Observed Accumulation Ratio (Rac) for Cmax and AUCtau of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|Rac for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study.||||||
2624523|NCT01923389|Secondary|Terminal Elimination Half-life (t1/2)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|t1/2 for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study.||||||
2624524|NCT01923389|Secondary|Clearance (CL)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|CL for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study.||||||
2624525|NCT01923389|Secondary|Time for Cmax (Tmax)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|Tmax for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarzied due to the premature termination of the study.||||||
2624526|NCT01923389|Secondary|Average Concentration at Steady State (Cav) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|Cav for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not reported due to the premature termination of the study.||||||
2624527|NCT01923389|Secondary|Lowest Concentration Observed During Dosing Interval (Cmin) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Day 25|Cmin for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarized due to the premature termination of the study.||||||
2624528|NCT01923389|Secondary|Maximum Plasma Concentration (Cmax) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Days 1 and 25|Cmax for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarized due to the premature termination of the study.||||||
2624529|NCT01923389|Secondary|Area Under the Concentration Versus Time Curve From Time 0 to Tau, the Dosing Interval (AUCtau) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)||Days 1 and 25|AUCtau for C-terminus and N-terminus of PF-05231023 and CVX-2000 were not summarized due to the premature termination of the study.||||||
2624530|NCT01923389|Primary|Number of Participants With Positive Anti-PF-05231023 Antibodies and Neutralizing Antibodies.|Anti-PF-05231023 antibodies were analyzed using a tiered testing strategy of screen, confirm, and titer characterization. Positive was defined as titer value >=6.23 and negative was defined as titer value <6.23. Samples tested positive were also to be analyzed in a neutralization assay to determine whether or not they were neutralizing or non-neutralizing.|Days 1 up to the last follow-up (Day 68)|All participants who received at least 1 dose of active study medication (PF-05231023). Neutralizing antibodies were not tested because all participants who received PF-05231023 100 mg tested negative for anti-PF-05231023 antibodies.|||Participants|||Number
2624531|NCT01923389|Secondary|Number of Participants With Abnormal Clinical Laboratory Measurements|The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.|Days -7 up to the last follow-up (Day 68)|All participants who received at least 1 dose of study medication (PF-05231023 or placebo).|||Participants|||Number
2624532|NCT01923389|Primary|Number of Participants With Electrocardiogram (ECG) Data Met Criteria of Potential Clinical Concern|ECG criteria of potential clinical concern were 1), PR interval:>=300 msec, >=25% increase when baseline >200 msec, or >=50% increase when baseline <=200 msec; 2), QRS interval:>=140 msec, or >=50% increase from baseline; 3), QT interval corrected for heart rate (QTc)/QTc interval using Fridericia's formula (QTcF):>=500 msec, QTcF interval: absolute value >=450 - <480 msec(borderline), >=480 msec (prolonged), absolute change 30 - <60 msec (borderline) or >=60 msec (prolonged). 12-lead ECG (triplicate) was performed on Day 0 and 12-lead ECG (singlet) was performed at other times.|Days -7 up to the last follow-up (Day 68)|All participants who received at least 1 dose of study medication (PF-05231023 or placebo).|||Participants|||Number
2624533|NCT01923389|Primary|Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern|Vital signs included supine systolic blood pressure, diastolic blood pressure and pulse rate. Vital signs criteria of potential clinical concern were 1), blood pressure: systolic greater than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in the same posture or systolic less than (<)90 mm Hg; diastolic >=20 mm Hg change from baseline in the same posture or diastolic <50 mm Hg; 2), Pulse rate: supine/Sitting: <40 or greater than (>) 120 beats per minute (bpm); Standing: <40 or >140 bpm.|Days -7 up to the last follow-up (Day 68)|All participants who received at least 1 dose of study medication (PF-05231023 or placebo).|||Participants|||Number
2624534|NCT01923389|Primary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were also reported for the 7-day pre-randomization period.|Day -7 through the last follow-up (Day 68)|All participants who received at least 1 dose of study medication (PF-05231023 or placebo).|||Participants|||Number
2624535|NCT01923363|Secondary|Volume of Distribution of Piperacillin|Volume of distribution (Vd) of piperacillin will be calculated from serum concentrations in both standard and high doses|0, 1, 3, and 6 hours post-dose|The # of participants in the rows below will be double the overall participant number because each patient had two different dosing regimens of pip/tazo In Group 3, 4.5g group N = 5 represents low and high dose – 2 patients receiving 4.5g upon enrollment and increased to 6.75g; 3 patients were receiving either 2.25g or 3.375g and increased to 4.5g|||liters||Full Range|Mean
2624536|NCT01923363|Secondary|Half-life of Piperacillin|Half-life (t1/2) of piperacillin will be calculated from serum concentrations in both standard and high doses|0, 1, 3, and 6 hours post-dose|The # of participants in the rows below will be double the overall participant number because each patient had two different dosing regimens of pip/tazo In Group 3, 4.5g group N = 5 represents low and high dose – 2 patients receiving 4.5g upon enrollment and increased to 6.75g; 3 patients were receiving either 2.25g or 3.375g and increased to 4.5g|||hours||Full Range|Mean
2624537|NCT01923363|Primary|Serum Minimum Concentrations of Piperacillin|Minimum serum concentrations (Cmin) of piperacillin will be measured in both standard and high doses|0, 1, 3, and 6 hours post-dose|The # of participants in the rows below will be double the overall participant number because each patient had two different dosing regimens of pip/tazo In Group 3, 4.5g group N = 5 represents low and high dose – 2 patients receiving 4.5g upon enrollment and increased to 6.75g; 3 patients were receiving either 2.25g or 3.375g and increased to 4.5g|||milligrams per liter||Full Range|Mean
2624538|NCT01923363|Primary|Serum Maximum Concentrations for Piperacillin|Pharmacokinetic parameters for piperacillin of maximum serum concentration (Cmax) will be measured in both standard dosing and high dosing.|0, 1, 3, and 6 hours post-dose|The # of participants in the rows below will be double the overall participant number because each patient had two different dosing regimens of pip/tazo In Group 3, 4.5g group N = 5 represents low and high dose – 2 patients receiving 4.5g upon enrollment and increased to 6.75g; 3 patients were receiving either 2.25g or 3.375g and increased to 4.5g|||milligrams per liter||Full Range|Mean
2624539|NCT01923311|Secondary|Adherence to EVG|Adherence was calculated as the number of pills taken divided by number of pills prescribed multiplied by 100.|Baseline up to the last dose date (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)|Safety Analysis Set|||percentage of pills||Standard Deviation|Mean
2624540|NCT01923311|Secondary|Palatability of Oral Suspension Formulation of EVG in Appropriate Age Group||Up to Week 48|Palatability was only to be assessed for participants taking EVG suspension formulation. As no participants were dosed with the EVG oral suspension formulation, no data are available on its palatability.||||||
2624541|NCT01923311|Secondary|Age of First Menses|Age of first menses for female participants.|Baseline through end of study (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years with Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years with Screening HIV-1 RNA < 50 copies/mL)|Participants in the Safety Analysis Set with available data were analyzed. Age of First Menses for participants ages 6 to < 12 years with screening HIV-1 RNA < 50 copies/mL was not analyzed because none of the participants reached their first menstruation cycle during or prior to the study.|||years||Standard Deviation|Mean
2624542|NCT01923311|Secondary|Tanner Stage Evaluation by Sex at Week 48|Tanner Stage (pubic hair and breasts for females; pubic hair and genitalia for males) at Week 48 visit was summarized using frequency count and percentage. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics).|Week 48|Participants in the Safety Analysis Set with available data were analyzed. Tanner Stage Assessments were not defined for participants with screening HIV-1 RNA < 50 copies/mL because there were no postbaseline assessments scheduled in the protocol for these participants.|||Participants|||Count of Participants
2624543|NCT01923311|Secondary|Tanner Stage Evaluation by Sex at Week 24|Tanner Stage (pubic hair and breasts for females; pubic hair and genitalia for males) at Week 24 visit was summarized using frequency count and percentage. Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics).|Week 24|Participants in the Safety Analysis Set with available data were analyzed. Tanner Stage Assessments were not defined for participants with screening HIV-1 RNA < 50 copies/mL because there were no postbaseline assessments scheduled in the protocol for these participants.|||Participants|||Count of Participants
2624544|NCT01923311|Secondary|Change From Baseline in CD4 Percentage at Week 48||Baseline to Week 48|Participants in the Full Analysis Set with available data were analyzed. Week 48 CD4 percentage data for participants with screening HIV-1 RNA < 50 copies/mL group was not analyzed due to the short duration of treatment (10 days).|||percentage (%)||Standard Deviation|Mean
2624545|NCT01923311|Secondary|Change From Baseline in CD4 Percentage at Week 24||Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed. Week 24 CD4 percentage data for participants with screening HIV-1 RNA < 50 copies/mL group was not analyzed due to the short duration of treatment (10 days).|||percentage (%)||Standard Deviation|Mean
2624546|NCT01923311|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline to Week 48|Participants in the Full Analysis Set with available data were analyzed. Week 48 CD4 Cell Count data for participants with screening HIV-1 RNA < 50 copies/mL was not analyzed due to the short duration of treatment (10 days).|||cells/uL||Standard Deviation|Mean
2624547|NCT01923311|Secondary|Change From Baseline in CD4 Cell Count at Week 24||Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed. Week 24 CD4 Cell Count data for participants with screening HIV-1 RNA < 50 copies/mL was not analyzed due to the short duration of treatment (10 days).|||cells/uL||Standard Deviation|Mean
2624548|NCT01923311|Secondary|Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 48||Baseline to Week 48|Participants in the Full Analysis Set with available data were analyzed. Week 48 Plasma Log₁₀ HIV-1 RNA data for participants with screening HIV-1 RNA < 50 copies/mL was not analyzed due to the short duration of treatment (10 days).|||Log₁₀ copies/ mL||Standard Deviation|Mean
2624549|NCT01923311|Secondary|Change From Baseline in Plasma Log₁₀ HIV-1 RNA at Week 24||Baseline to Week 24|Participants in the Full Analysis Set with available data were analyzed. Week 24 Plasma Log₁₀ HIV-1 RNA data for participants with screening HIV-1 RNA < 50 copies/mL was not analyzed due to the short duration of treatment (10 days).|||Log₁₀ copies/mL||Standard Deviation|Mean
2624550|NCT01923311|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Participants in the Full Analysis Set with available data were analyzed. Week 48 HIV-1 RNA copies for participants with screening HIV-1 RNA < 50 copies/mL were not analyzed due to the short duration of treatment (10 days).|||percentage of participants||95% Confidence Interval|Number
2624551|NCT01923311|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 400 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Participants in the Full Analysis Set with available data were analyzed. Week 24 HIV-1 RNA copies for participants with screening HIV-1 RNA < 50 copies/mL were not analyzed due to the short duration of treatment (10 days).|||percentage of participants||95% Confidence Interval|Number
2624552|NCT01923311|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Participants in the Full Analysis Set with available data were analyzed. Week 48 HIV-1 RNA copies for participants with screening HIV-1 RNA < 50 copies/mL were not analyzed due to the short duration of treatment (10 days).|||percentage of participants||95% Confidence Interval|Number
2624553|NCT01923311|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the FDA Snapshot Algorithm|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: all participants who were enrolled in the study and received at least 1 dose of study drug. Participants in the Full Analysis Set with available data were analyzed. Week 24 HIV-1 RNA copies for participants with screening HIV-1 RNA < 50 copies/mL were not analyzed due to the short duration of treatment (10 days).|||percentage of participants||95% Confidence Interval|Number
2624554|NCT01923311|Secondary|Pharmacokinetic (PK) Parameter: Vz/F of EVG|Vz/F is defined as the apparent volume of distribution of the drug.|Predose and up to 12 hours postdose on Day 10|Participants in the Intensive PK Analysis Set: EVG with available data were analyzed.|||mL||Standard Deviation|Mean
2624555|NCT01923311|Secondary|Pharmacokinetic (PK) Parameter: CL/F of EVG|CL/F is defined as the apparent oral clearance following administration of the drug.|Predose and up to 12 hours postdose on Day 10|Intensive PK Analysis set (EVG)|||mL/h||Standard Deviation|Mean
2624556|NCT01923311|Secondary|Pharmacokinetic (PK) Parameter: Ctau of EVG|Ctau is defined as the observed drug concentration at the end of the dosing interval.|Predose and up to 12 hours postdose on Day 10|Intensive PK Analysis Set (EVG)|||ng/mL||Standard Deviation|Mean
2624557|NCT01923311|Primary|Percentage of Participants Experiencing Laboratory Abnormalities|Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each subject. The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (life-threatening).|Baseline up to the last dose date plus 30 days (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)|Safety Analysis Set|||percentage of participants|||Number
2624558|NCT01923311|Primary|Percentage of Participants Experiencing Treatment-emergent Adverse Events||Baseline up to the last dose date plus 30 days (maximum exposure: 173.6 weeks for participants age 6 to < 18 Years Screening HIV-1 RNA > 1000 copies/mL and 2.0 weeks for participants age 6 to < 12 Years Screening HIV-1 RNA < 50 copies/mL)|Safety Analysis Set|||percentage of participants|||Number
2624559|NCT01923311|Primary|Pharmacokinetic (PK) Parameter: Cmax of EVG at Day 10|Cmax is defined as the maximum concentration of drug.|Predose and up to 12 hours postdose on Day 10|Intensive PK Analysis Set (EVG)|||ng/mL||Standard Deviation|Mean
2624560|NCT01923311|Primary|Pharmacokinetic (PK) Parameter: AUCtau of EVG|AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).|Predose and up to 12 hours postdose on Day 10|Intensive PK Analysis Set(EVG): all enrolled participants who received at least 1 dose of study drug and for whom steady-state pharmacokinetic profiles of the analyte of interest at the Intensive PK(Day 10) visit were evaluable.Includes 12 participants with screening HIV-1 RNA<50 copies/mL and 2 participants with screening HIV-1 RNA>1000 copies/mL.|||h*ng/mL||Standard Deviation|Mean
2624561|NCT01923181|Secondary|Number of Confirmed Hypoglycaemic Episodes Recorded|Treatment-emergent confirmed hypoglycaemic episodes were recorded during weeks 0-31 (26 weeks treatment period + 5 weeks follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Confirmed hypoglycaemic episode is an episode that is severe according to the American Diabetes Association (ADA) classification or plasma glucose value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia.|Weeks 0-31|Overall number of participants analyzed = SAS which comprised all participants exposed to at least 1 dose of randomised semaglutide or placebo.|||Episodes|||Number
2624562|NCT01923181|Secondary|Number of Treatment Emergent Adverse Events (TEAEs) Recorded|TEAEs were recorded during weeks 0-31 (26 weeks treatment period+5 weeks follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication.|Weeks 0-31|Overall number of participants analyzed = safety analysis set (SAS) which comprised all participants exposed to at least 1 dose of randomised semaglutide or placebo.|||Events|||Number
2624563|NCT01923181|Secondary|Change in Body Mass Index (BMI)|Change from baseline (week 0) in body mass index (BMI) was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||kg/m^2||Standard Deviation|Mean
2624564|NCT01923181|Secondary|Change in Waist Circumference|Change from baseline (week 0) in waist circumference was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||cm||Standard Deviation|Mean
2624565|NCT01923181|Secondary|Change in Body Weight|Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Week 0, Week 26|Overall number of participants analyzed = number of participants with available data.|||kg||Standard Deviation|Mean
2624566|NCT01923181|Secondary|Subjects Who Achieve (Yes/no) HbA1c Below 7 Percent (53 mmol/Mol)|Participants who achieved HbA1c <7.0%, was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|After 26 weeks of treatment|Overall number of participants analyzed = number of participants with available data.|||Participants|||Count of Participants
2624567|NCT01923181|Primary|Change in HbA1c (Glycosylated Haemoglobin)|Change from baseline (week 0) in HbA1c was evaluated at week 26. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.|Week 0, week 26|Overall number of participants analyzed = number of participants with available data.|||Percentage of HbA1c||Standard Deviation|Mean
2624568|NCT01923168|Secondary|Buparlisib PK Parameter: Tmax at Cycle 4 Day 1|Summary of primary PK parameters for buparlisib plasma concentration|Cycle 4 Day 1 (each cycle is 28 days)|Buparlisib Pharmacokinetic Analysis Set (BKM PAS): The BKM PAS included all participants who received at least one dose of buparlisib and had at least one evaluable post-treatment buparlisib concentration measurement.|||hr||Full Range|Median
2624569|NCT01923168|Secondary|Buparlisb PK Parameter: Cmax at Cycle 4 Day 1|Summary of primary PK parameters for buparlisib plasma concentration|Cycle 4 Day 1 (each cycle is 28 days)|Buparlisib Pharmacokinetic Analysis Set (BKM PAS): The BKM PAS included all participants who received at least one dose of buparlisib and had at least one evaluable post-treatment buparlisib concentration measurement.|||ng/mL||Full Range|Median
2624570|NCT01923168|Secondary|Buparlisib PK Parameter: AUClast at Cycle 4 Day 1|Summary of primary PK parameters for Buparlisib plasma concentration|0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days)|BKM FPAS: The BKM FPAS included participants who received at least 1 dose of buparlisib, had at least 1 evaluable post-treatment concentration, received adequate doses of buparlisib and letrozole prior to full PK assessment, did not vomit within 4 hours of buparlisib or letrozole dosing on the day of full PK and had an evaluable full PK profile.|||ng*hr/mL||Full Range|Median
2624571|NCT01923168|Secondary|Buparlisib PK Parameter: Tmax at Cycle 1 Day 1|Summary of primary PK parameters for buparlisib plasma concentration|Cycle 1 Day 1 (each cycle is 28 days)|Buparlisib Pharmacokinetic Analysis Set (BKM PAS): The BKM PAS included all participants who received at least one dose of buparlisib and had at least one evaluable post-treatment buparlisib concentration measurement.|||hr||Full Range|Median
2624572|NCT01923168|Secondary|Buparlisib PK Parameter: Cmax at Cycle 1 Day 1|Summary of primary PK parameters for buparlisib plasma concentration|Cycle 1 Day 1 (each cycle is 28 days)|The BKM FPAS included participants who received at least 1 dose of buparlisib, had at least 1 evaluable post-treatment concentration, received adequate doses of buparlisib and letrozole prior to full PK assessment, did not vomit within 4 hours of buparlisib or letrozole dosing on the day of full PK and had an evaluable full PK profile.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2624573|NCT01923168|Secondary|Buparlisib PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1|Summary of primary PK parameters for Buparlisib plasma concentration|0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days)|The BKM FPAS included participants who received at least 1 dose of buparlisib, had at least 1 evaluable post-treatment concentration, received adequate doses of buparlisib and letrozole prior to full PK assessment, did not vomit within 4 hours of buparlisib or letrozole dosing on the day of full PK and had an evaluable full PK profile.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2624574|NCT01923168|Secondary|Letrozole PK Parameter: Tmax at Cycle 4 Day 1|Summary of primary PK parameters for letrozole plasma concentration|Cycle 4 Day 1 (each cycle is 28 days)|The LZ FPAS included participants who received at least 1 dose of letrozole, had at least 1 evaluable post-treatment letrozole concentration, received adequate doses of letrozole prior to full PK assessment, did not vomit within 4 hours of letrozole dosing on the day of full PK and had an evaluable full PK profile.|||hr||Full Range|Median
2624575|NCT01923168|Secondary|Letrozole PK Parameter: Cmax at Cycle 4 Day 1|Summary of primary PK parameters for letrozole plasma concentration|Cycle 4 Day 1 (each cycle is 28 days)|The LZ FPAS included participants who received at least 1 dose of letrozole, had at least 1 evaluable post-treatment letrozole concentration, received adequate doses of letrozole prior to full PK assessment, did not vomit within 4 hours of letrozole dosing on the day of full PK and had an evaluable full PK profile.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2624576|NCT01923168|Secondary|Letrozole PK Parameters: AUC0-24, AUClast at Cycle 4 Day 1|Summary of primary PK parameters for Letrozole plasma concentration|0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days)|Letrozole Pharmacokinetic Analysis Set (LZ PAS): The LZ PAS included all participants who received at least one dose of letrozole and had at least one evaluable post-treatment letrozole concentration measurement.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2624577|NCT01923168|Secondary|Letrozole PK Parameter: Tmax at Cycle 1 Day 1|Summary of primary PK parameters for letrozole plasma concentration|Cycle 1 Day 1 (each cycle is 28 days)|The LZ FPAS included participants who received at least 1 dose of letrozole, had at least 1 evaluable post-treatment letrozole concentration, received adequate doses of letrozole prior to full PK assessment, did not vomit within 4 hours of letrozole dosing on the day of full PK and had an evaluable full PK profile.|||hr||Full Range|Median
2624578|NCT01923168|Secondary|Letrozole PK Parameter: Cmax at Cycle 1 Day 1|Summary of primary PK parameters for letrozole plasma concentration|Cycle 1 Day 1 (each cycle is 28 days)|The LZ FPAS included participants who received at least 1 dose of letrozole, had at least 1 evaluable post-treatment letrozole concentration, received adequate doses of letrozole prior to full PK assessment, did not vomit within 4 hours of letrozole dosing on the day of full PK and had an evaluable full PK profile.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2624579|NCT01923168|Secondary|Letrozole and PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1|Summary of primary PK parameters for Letrozole plasma concentration|0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days)|The LZ FPAS included participants who received at least 1 dose of letrozole, had at least 1 evaluable post-treatment letrozole concentration, received adequate doses of letrozole prior to full PK assessment, did not vomit within 4 hours of letrozole dosing on the day of full PK and had an evaluable full PK profile.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2624580|NCT01923168|Secondary|Alpelisib PK Parameter: Tmax at Cycle 4 Day 1|Summary of primary PK parameters for alpelisib plasma concentration|Cycle 4 Day 1 (each cycle is 28 days)|Alpelisib Pharmacokinetic Analysis Set (BYL PAS): The BYL PAS included all participants who received at least one dose of alpelisib and had at least one evaluable post-treatment alpelisib concentration measurement.|||hr||Full Range|Median
2624581|NCT01923168|Secondary|Alpelisib PK Parameter: Cmax at Cycle 4 Day 1|Summary of primary PK parameters for alpelisib plasma concentration|Cycle 4 Day 1 (each cycle is 28 days)|Alpelisib Pharmacokinetic Analysis Set (BYL PAS): The BYL PAS included all participants who received at least one dose of alpelisib and had at least one evaluable post-treatment alpelisib concentration measurement.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2624582|NCT01923168|Secondary|Alpelisib PK Parameters: AUC0-24, AUClast at Cycle 4 Day 1|Summary of primary PK parameters for alpelisib plasma concentration|0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 4 Day 1 (each cycle is 28 days)|The BYL FPAS included participants who received at least 1 dose of alpelisib, had at least 1 evaluable post-treatment alpelisib concentration, received adequate doses of alpelisib and letrozole prior to full PK assessment, did not vomit within 4 hours of alpelisib or letrozole dosing on the day of full PK and had an evaluable full PK profile.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2624583|NCT01923168|Secondary|Alpelisib and PK Parameter: Tmax at Cycle 1 Day 1|Summary of primary PK parameters for alpelisib plasma concentration|Cycle 1 Day 1 (each cycle is 28 days)|Alpelisib Pharmacokinetic Analysis Set (BYL PAS): The BYL PAS included all participants who received at least one dose of alpelisib and had at least one evaluable post-treatment alpelisib concentration measurement.|||HR||Full Range|Median
2624584|NCT01923168|Secondary|Alpelisib PK Parameter: Cmax at Cycle 1 Day 1|Summary of primary PK parameters for alpelisib plasma concentration|Cycle 1 Day 1 (each cycle is 28 days)|The BYL FPAS included participants who received at least 1 dose of alpelisib, had at least 1 evaluable post-treatment alpelisib concentration, received adequate doses of alpelisib and letrozole prior to full PK assessment, did not vomit within 4 hours of alpelisib or letrozole dosing on the day of full PK and had an evaluable full PK profile.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2624585|NCT01923168|Secondary|Alpelisib PK Parameters: AUC0-24, AUClast at Cycle 1 Day 1|Summary of primary PK parameters for alpelisib plasma concentration|0, 0.5, 1, 3, 6, 9 and 24 hours post-dose at Cycle 1 Day 1 (each cycle is 28 days)|The BYL FPAS included participants who received at least 1 dose of alpelisib, had at least 1 evaluable post-treatment alpelisib concentration, received adequate doses of alpelisib and letrozole prior to full PK assessment, did not vomit within 4 hours of alpelisib or letrozole dosing on the day of full PK and had an evaluable full PK profile.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2624586|NCT01923168|Secondary|Preoperative Endocrine Prognostic Index (PEPI) Response as Per Central Assessment for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort|Preoperative endocrine prognostic index (PEPI) response as per central assessment for alpelisib vs. placebo - PIK3CA wild-type cohort. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and ER status of the surgical specimen (Ellis et al, Contemp Clin Trials 2008). The PEPI score ranges from 0 to to 12, and a higher score means a worse outcome. PEPI response is defined as a PEPI score of 0.|At the time of surgery (expected after 24 weeks of treatment)|The Full Analysis Set (FAS) for the PIK3CA wild-type cohort comprised all randomized participants who were assigned to the PIK3CA wild-type cohort based on tumor tissue for the randomization.|||Number of participants|||Number
2624587|NCT01923168|Secondary|Preoperative Endocrine Prognostic Index (PEPI) Response as Per Central Assessment for Alpelisib vs. Placebo - PIK3CA Mutant Cohort|Preoperative endocrine prognostic index (PEPI) response as per central assessment for alpelisib vs. placebo - PIK3CA mutant cohort. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and ER status of the surgical specimen (Ellis et al, Contemp Clin Trials 2008). The PEPI score ranges from 0 to to 12, and a higher score means a worse outcome. PEPI response is defined as a PEPI score of 0.|At the time of surgery (expected after 24 weeks of treatment)|The Full Analysis Set (FAS) for the PIK3CA mutant cohort comprised all randomized participants who were assigned to the PIK3CA mutant cohort based on tumor tissue for the randomization.|||Number of participants|||Number
2624588|NCT01923168|Secondary|Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort: Non-responders as Per pCR|Association between pCR and changes in Ki67 from baseline for alpelisib vs. placebo - PIK3CA wild-type cohort: non-responders as per pCR|Baseline, Cycle 1 Day 15 (each cycle is 28 days) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)|The Full Analysis Set (FAS) for the PIK3CA wild-type cohort comprised all randomized participants who were assigned to the PIK3CA wild-type cohort based on tumor tissue for the randomization. Only non-responders as per pCR are considered for this analysis.|||Percentage of positive cells||Full Range|Median
2624589|NCT01923168|Secondary|Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort: Responders as Per pCR|Association between pCR and changes in Ki67 from baseline for alpelisib vs. placebo - PIK3CA wild-type cohort: responders as per pCR|Baseline, Cycle 1 Day 15 (each cycle is 28 days) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)|FAS for PIK3CA wild-type cohort comprised all rand. Parts. assigned to PIK3CA wild-type cohort based on tumor tissue for rand. Only responders as per pCR were considered for this analysis. No patient had data reported at C1D15 & EOT for Placebo, hence percent change from baseline could not be reported.|||Percentage of positive cells||Full Range|Median
2624590|NCT01923168|Secondary|Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Non-responders as Per pCR|Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Non-responders as Per pCR.|Baseline, Cycle 1 Day 15 (each cycle is 28 days ) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)|The Full Analysis Set (FAS) for the PIK3CA mutant cohort comprised all randomized participants who were assigned to the PIK3CA mutant cohort based on tumor tissue for the randomization. Only non-responders as per pCR are considered for this analysis.|||Percentage of positive cells||Full Range|Median
2624591|NCT01923168|Secondary|Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Responders as Per pCR|Association Between pCR and Changes in Ki67 From Baseline for Alpelisib vs. Placebo - PIK3CA Mutant Cohort: Responders as Per pCR|Baseline, Cycle 1 Day 15 (each cycle is 28 days) and surgery (End of Treatment (EOT) expected after 24 weeks of treatment)|The FAS for the PIK3CA mutant cohort comprised all randomized participants who were assigned to the PIK3CA mutant cohort based on tumor tissue for the randomization. Only responders as per pCR were considered for this analysis. No patient had data reported at end of trial (EOT), hence the percent change from baseline at EOT could not be reported.|||Percentage of positive cells||Full Range|Median
2624592|NCT01923168|Secondary|Rate of Breast Conserving Surgery for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort|"Breast conserving surgery is defined as the percentage of participants with no mastectomy following completion of 24 weeks of treatment. Breast conserving surgery is defined for participants who underwent surgery and did not have a mastectomy. The row no surgery provides the number of patients who did not undergo surgery at all for various reasons."|After 24 weeks of treatment|The Full Analysis Set (FAS) for the PIK3CA wild-type cohort comprised all randomized participants who were assigned to the PIK3CA wild-type cohort based on tumor tissue for the randomization. PIK3CA mutation is based on tumor tissue.|||Percentage of participants||80% Confidence Interval|Number
2624593|NCT01923168|Secondary|Rate of Breast Conserving Surgery for Alpelisib vs. Placebo - PIK3CA Mutant Cohort|"Breast conserving surgery is defined for participants who underwent surgery and did not have a mastectomy. The row no surgery provides the number of patients who did not undergo surgery at all for various reasons."|After 24 weeks of treatment|The Full Analysis Set (FAS) for the PIK3CA mutant cohort comprised all randomized participants who were assigned to the PIK3CA mutant cohort based on tumor tissue for the randomization. PIK3CA mutation is based on tumor tissue.|||Percentage of participants||80% Confidence Interval|Number
2624594|NCT01923168|Secondary|pCR and Objective Response Rate According to RECIST 1.1 Criteria Per Investigator Assessment for Alpelisib vs. Placebo in PIK3CA Wild-type Cohort Based on ctDNA|pCR and Objective response rate according to RECIST 1.1 per investigator assessment after 24 weeks of treatment|After 24 weeks of treatment|The Full Analysis Set (FAS) comprised all randomized participants in the study. This analysis was to be done in PIK3CA wild-type patients based on Circulating tumor DNA (ctDNA). Data could not be reported in this table as the ctDNA analysis was not done after the primary endpoint was negative.||||||
2624595|NCT01923168|Secondary|pCR and Objective Response Rate According to RECIST 1.1 Criteria Per Investigator Assessment for Alpelisib vs. Placebo in PIK3CA Mutant Cohort Based on ctDNA|pCR and Objective response rate according to RECIST 1.1 per investigator assessment after 24 weeks of treatment|After 24 weeks of treatment|The FAS comprised all randomized participants. This analysis was to be done in patients with PIK3CA mutation based on Circulating tumor DNA (ctDNA). Data could not be reported as the ctDNA analysis was not done after the primary endpoint was negative.||||||
2624604|NCT01922986|Primary|Percent Change From Baseline in Jebsen Taylor Hand Function Test Scores|This test quantifies the time it takes for the subject to do the following standardized functional tasks with the hand: stack three checkers, turn over cards, turn over empty cans, turn over fluid-filled cans, pick up and place small items like a paper clip, etc into a can, and use a spoon to scoop up a bean and drop the bean into a can. The unit of measure is time and changes that are negative signify reduced time at posttest compared to pretest, which would be an improvement. Total score = sum of times for each subtests|Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).||||percentage of change from baseline||Standard Deviation|Mean
2624596|NCT01923168|Primary|Objective Response Rate According to RECIST 1.1 Per Investigator Assessment for Alpelisib vs. Placebo - PIK3CA Wild-type Cohort|"Objective Response Rate (ORR) defined as the proportion of patients with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1.~BOR was assessed per MRI or Ultrasound and defined as per RECIST 1.1 as CR for a disappearance of all non-nodal target lesions (TL)/non-target lesions (NTL) and a reduction in short axis to < 10 mm of any pathological lymph nodes assigned as TL/NTL and no new lesion; as PR if not qualifying for CR but with a decrease from baseline ≥ 30% in the sum of diameter of all TL, no progression of NTL and no new lesion."|After 24 weeks of treatment|The Full Analysis Set (FAS) for the PIK3CA wild-type cohort comprised all randomized participants who were assigned to the PIK3CA wild-type cohort based on tumor tissue for the randomization.|||Percentage of Participants||80% Confidence Interval|Number
2624597|NCT01923168|Primary|Objective Response Rate Per Investigator Assessment According to RECIST 1.1 for Alpelisib vs. Placebo - PIK3CA Mutant Cohort|"Objective Response Rate (ORR) defined as the proportion of patients with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1.~BOR was assessed per MRI or Ultrasound and defined as per RECIST 1.1 as CR for a disappearance of all non-nodal target lesions (TL)/non-target lesions (NTL) and a reduction in short axis to < 10 mm of any pathological lymph nodes assigned as TL/NTL and no new lesion; as PR if not qualifying for CR but with a decrease from baseline ≥ 30% in the sum of diameter of all TL, no progression of NTL and no new lesion."|After 24 weeks of treatment|The Full Analysis Set (FAS) for the PIK3CA mutant cohort comprised all randomized participants who were assigned to the PIK3CA mutant cohort based on tumor tissue for the randomization.|||Percentage of Participants||80% Confidence Interval|Number
2624598|NCT01923168|Primary|Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Wild-type Cohort|Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were considered as non-responders for the calculation of pCR rate.|After 24 weeks of treatment|The Full Analysis Set (FAS) for the PIK3CA wild-type cohort comprised all randomized participants who were assigned to the PIK3CA wild-type cohort based on tumor tissue for the randomization.|||Percentage of Participants||80% Confidence Interval|Number
2624599|NCT01923168|Primary|Pathological Complete Response (pCR) Per Investigator Assessment for Alpelisib vs. Placebo for PIK3CA Mutant Cohort|Pathologic complete response (pCR) defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of 24 weeks of treatment by local assessment (ypT0/Tis ypN0). Patients who experienced progression of disease while undergoing neoadjuvant therapy, or who did not receive surgery for any reason, or received antineoplastic treatment other than study drug(s) before surgery were considered as non-responders for the calculation of pCR rate.|After 24 weeks of treatment|The Full Analysis Set (FAS) for the PIK3CA mutant cohort comprised all randomized participants who were assigned to the PIK3CA mutant cohort based on tumor tissue for the randomization.|||Percentage of Participants||80% Confidence Interval|Number
2624600|NCT01923129|Secondary|Number of Participants With a Symptomatic Urinary Tract Infection|Urinary tract infection defined as symptomatic urinary complaints such as dysuria, with urinalysis consistent with infection.|During 1 week of hospitalization (prior to discharge)||||Participants|||Count of Participants
2624601|NCT01923129|Primary|Number of Participants With Acute Urinary Retention|Acute urinary retention will be defined as catheter discontinuation with inability to void 6 hours post-removal, or void with post-void residual greater than 200 cc of urine.|Postoperative day 1 or postpoperative 3 depending on group randomization||||Participants|||Count of Participants
2624602|NCT01922986|Secondary|Change in Motricity Index|"Measures strength in finger pinch, elbow flexion and arm abduction. 0 No pinch movement. 11 Slight movement of finger or thumb. 19 Able to grip the cube, but not hold it against gravity. 22 Able to grip and hold the cube against gravity, but not against a weak pull by examiner.~The weighted score based on the ordinal 6 point scale 26 Able to grip and hold the cube against a weak pull, but weaker than the other side.~33 Normal pinch grip.~For shoulder and elbow scoring is:~0 No movement. 9 Palpable contraction in muscle, but no movement. 14 Visible movement, but not full range and not against gravity. 19 Full range of movement against gravity but not against resistance. 25 Full movement against resistance, but weaker than the other side. 33 Normal power. Maximum total score is 99, minimum is 0. Changes that are positive signify improved strength at postte"|Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).||||units on a scale||Standard Deviation|Mean
2624603|NCT01922986|Secondary|Change in Finger Tracking Test|This test involves placing a device on the hand that shows the changing angle of the finger joint on a computer screen as the joint is moved. The computer screen also shows a target line, such as a sine wave. At the start of the test, the computer screen cursor moves horizontally across the target and the subject moves the finger joint into extension or flexion to adjust the vertical position of the cursor to that it traces the target line as accurately as possible. The performance is quantified by calculating the root-mean-square error between the target line and the response line. This is converted into an Accuracy Index, which has a maximum value of 100% (perfect score). Negative values can occur and reach a value of -100%, signifying very poor performance. Typical scores for healthy range from 50-80%. Typical values in stroke range from -100 to +40%. Changes that are positive signify increased tracking accuracy at posttest compared to pretest, which would be an improvement.|Measured at pretest (day before treatments begin) and posttest (day following last treatment). Thus, 7 days of participation (1 pretest, 5 treatments, 1 posttest).||||units on a scale||Standard Deviation|Mean
2624605|NCT01922934|Primary|Health Care Utilization - Laboratory Measurements|Evaluation of differences in health care resource utilization between Tool and Control groups during the study period. Health care resource utilization defined as the number of number of lab measurements taken during the period (including A1C, creatinine, and lipids).|1 year study period||||Number of measurements||95% Confidence Interval|Least Squares Mean
2624606|NCT01922934|Secondary|Documentation of Obesity|"To assess:~Presence of ICD-9 code for obesity in the DHHA registry Control Group~Evidence of a specific intervention for weight management resembling what was offered in the toolbox intervention: weight loss medication prescribed, gym membership, weight loss program or referral to wt loss specialist, and meal replacements"|1 year study period|Random sample of 120 patient medical records from the DHHA registry Control Group with recorded BMI > or = to 30 plus one comorbidity|||Participants|||Count of Participants
2624607|NCT01922934|Primary|Health Care Utilization - Non-study Clinic Visits|Evaluation of differences in health care resource utilization between Tool and Control groups during the study period. Health care resource utilization defined as the number of non-study clinic visits.|1 year study period||||Number of visits||95% Confidence Interval|Least Squares Mean
2624608|NCT01922934|Primary|Percentage of Participants Who Achieved >5% Weight Loss at 12 Months|Participants who had both a baseline and 12 month weight measurement were included. Weight change at 12 months was measured as a percent difference from their starting weight.|1 year||||percentage of participants|||Number
2624609|NCT01922739|Secondary|Percentage of Participants Withdrawn From the Study For Lack of Efficacy|Percentage of patients who withdrew from the study for lack of efficacy, as indicated on the early termination form of the case report form (CRF).|Day 1 of the Titration/Adjustment Period to Week 22 of the Treatment Period (total of 25-26 weeks)|Safety Analysis Set|||percentage of participants|||Number
2624610|NCT01922739|Secondary|Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Average Pain Intensity (API) Scores During the Previous 24 Hours for Each Visit|"The API was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. Participants selected the number that best described their average pain intensity over the last 24 hours. Negative change from baseline scores indicate improvement in pain control.~Endpoint refers to the last observation carried forward."|Baseline (Day 0 of Treatment Period), Weeks 2, 6, 10, 14, 18, 22 and Endpoint during the Open-Label Treatment Period|Full Analysis Set includes participants who had at least one post-baseline efficacy assessment. Participants contributing to each time point are counted as part of the number of participants analyzed for that test.|||units on a scale||Standard Deviation|Mean
2624611|NCT01922739|Secondary|Change From Baseline to Weeks 2, 6, 10, 14, 18, 22 and Endpoint of the Treatment Period in Daily Worst Pain Intensity (WPI) Scores During the Previous 24 Hours for Each Visit|"The WPI was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. At each visit, participants selected the number that best described their worst pain intensity over the last 24 hours. Negative change from baseline scores indicate improvement in pain control.~Endpoint refers to the last observation carried forward."|Baseline (Day 0 of Treatment Period), Weeks 2, 6, 10, 14, 18, 22 and Endpoint during the Open-Label Treatment Period|Full Analysis Set includes participants who had at least one post-baseline efficacy assessment. Participants contributing to each time point are counted as part of the number of participants analyzed for that test.|||units on a scale||Standard Deviation|Mean
2624612|NCT01922739|Primary|Participants With Clinically Significant (CS) Hearing Changes From Baseline to the Final Visit in Pure Tone Audiometry Test Results|"Pure tone audiometry was performed by trained personnel. Hearing loss was classified in degrees of hearing from normal to profound. This classification was determined by the hearing threshold (or the softest sound detected at a specific frequency). The exact ranges that classified hearing loss depended on the exact technique used during testing and on the patient's age. These values were provided by each audiology laboratory that performed the test. For serial audiograms, the criteria for a clinically significant hearing change were based on guidance from the American Speech Language Hearing Association (ASHA 1994, cited in [Konrad-Martin et al 2005]). These criteria included the following: greater than 20 decibels (dB) pure tone threshold shift at 1 frequency; greater than 10 dB shift at 2 consecutive test frequencies; or threshold response shifting to no response at 3 consecutive test frequencies."|Baseline was within two weeks of the final study visit in study 3103; during study exam was within two weeks of the end of trial visit for study 3104 (up to study week 26)|Safety Analysis Set|||Participants|||Count of Participants
2624613|NCT01922739|Primary|Shifts From Baseline to Endpoint (Treatment Period) in Electrocardiogram (ECG) Findings|"A 12-lead ECG was conducted at the final visit for study 3103 which is used as baseline for this study, and at week 22 of the treatment period [or early termination]). A qualified physician at the study center was responsible for providing interpretation of the ECG.~Endpoint refers to the last observation carried forward."|Baseline (final visit for study 3103), End of trial visit (up to week 22 of Open-label Treatment Period which is up to week 26 including the titration/adjustment period)|Post-Titration Safety Analysis Set. Includes participants who have both baseline and endpoint data.|||Participants|||Count of Participants
2624614|NCT01922739|Primary|Participants With Shifts From Normal to Abnormal in Physical Examination Findings|The endpoint visit or early termination visit was an abbreviated exam. Endpoint refers to the last observation carried forward.|End of trial visit (up to week 22 of Open-label Treatment Period which is up to week 26 including the titration/adjustment period)|Post-Titration Safety Analysis Set|||Participants|||Count of Participants
2624615|NCT01922739|Primary|Participants With Potentially Clinically Significant Abnormal Vital Signs Values|"Data represents participants with potentially clinically significant (PCS) vital sign values.~Significance criteria~Pulse - high: >=120 and increase of >= 15 beats/minute from baseline~Pulse - low: <=50 and decrease of >=15 beats/minute~Systolic blood pressure - high: >=180 and increase >=20 mmHg~Systolic blood pressure - low: <=90 and decrease >=20 mmHg~Diastolic blood pressure - high: >=105 and increase of >=15 mmHg~Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg"|Day 1 of the Titration/Adjustment Period to Week 22 of the Treatment Period (total of 25-26 weeks)|The Full Analysis Set includes all participants who took at least one dose of study drug and who had at least 1 post-baseline efficacy assessment. Participants with a post-baseline vital sign result are counted as part of the number of participants analyzed.|||Participants|||Count of Participants
2624662|NCT01922050|Primary|Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Counts (Multiple Imputation)||At Week 8|The analysis was based on the Full Analysis Set, which was defined as all randomized participants who applied investigation product. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and thus was excluded from the efficacy analysis.|||percentage of reduction||95% Confidence Interval|Mean
2624616|NCT01922739|Primary|Participants With Potentially Clinically Significant Abnormal Laboratory Values|"Data represents participants with potentially clinically significant abnormal serum chemistry, hematology and urinalysis values.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Creatinine: >=177 μmol/L~Uric acid: M>=625, F>=506 μmol/L~Aspartate aminotransferase (AST): >=3* upper limit of normal (ULN)~Alkaline phosphatase: >=3* upper limit of normal (ULN)~Gamma-glutamyl transpeptidase (GGT): >=3* upper limit of normal (ULN)~Serum white blood cells: >=20 * 10^9/L~Hemoglobin: M<=115, F<=95 g/dL~Hematocrit: M<0.37, F<0.32 L/L~Eosinophils: >=10.0 %~Platelets: <=75 * 10^9/L~Absolute neutrophils: <=1.0 * 10^9/L~Urinalysis: Glucose, Ketones, and Total Protein: >=2 unit increase from baseline"|End of trial visit (up to week 22 of Open-label Treatment Period which is up to week 26 including the titration/adjustment period)|The Full Analysis Set includes all participants who took at least one dose of study drug and who had at least 1 post-baseline efficacy assessment. Participants with a post-baseline result for each test are counted as part of the number of participants analyzed for that test.|||Participants|||Count of Participants
2624617|NCT01922739|Primary|Participants With Adverse Events|An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 of the Titration/Adjustment Period to Week 22 of the Treatment Period (total of 25-26 weeks)|Safety Analysis Set for the Titration/Adjustment period; Post-Titration/Post-Adjustment Safety Analysis Set for the Open-Label Treatment Period|||Participants|||Count of Participants
2624618|NCT01922349|Secondary|RA,AUC (Accumulation Ratio of the Analyte in Plasma at Steady State After Multiple Dose Administration Over a Uniform Dosing Interval Tau)|Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval tau, expressed as ratio of AUC at steady state and after single dose|0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,24h,36h,48h,~72h in SRD and ~24h,~72h,~120h,~168h,~216h,~228h,~264h,~276h,~312h,~312.25h,312.5h,312.75h,313h,313.5h,314h,314.5h,315h,316h,318h,320h,322h,324h,328h,336h,348h,360h,384h in MRD|PKS|||Ratio of AUC||Geometric Coefficient of Variation|Geometric Mean
2624619|NCT01922349|Secondary|RA,Cmax (Accumulation Ratio of the Analyte in Plasma at Steady State After Multiple Oral Administration Over a Uniform Dosing Interval Tau)|Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of Cmax at steady state and after single dose|0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,24h,36h,48h,~72h in SRD and ~24h,~72h,~120h,~168h,~216h,~228h,~264h,~276h,~312h,~312.25h,312.5h,312.75h,313h,313.5h,314h,314.5h,315h,316h,318h,320h,322h,324h,328h,336h,348h,360h,384h in MRD|PKS|||Ratio of Cmax||Geometric Coefficient of Variation|Geometric Mean
2624620|NCT01922349|Secondary|t1/2,ss|Terminal half-life of the analyte in plasma at steady state|23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h|PKS|||hours||Geometric Coefficient of Variation|Geometric Mean
2624621|NCT01922349|Secondary|AUCtau,ss|Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval tau|23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h|PKS|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2624622|NCT01922349|Secondary|Tmax,ss|Time from last dosing to maximum concentration of the analyte in plasma at steady state|23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h|PKS|||hours||Full Range|Median
2624623|NCT01922349|Secondary|Cmax,ss|Maximum measured concentration of the analyte in plasma at steady state|23.92h, 71.92h, 119.92h, 167.92h, 215.92h, 227.92h, 263.92h, 275.92h, 311.92h, 312.25h, 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 348h, 360h, 384h|PKS|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2624624|NCT01922349|Secondary|t1/2 (Terminal Half-life of the Analyte in Plasma After the First Dose)|Terminal half-life of the analyte in plasma after a single dose of BI 113608.|0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|PKS|||hours||Geometric Coefficient of Variation|Geometric Mean
2624625|NCT01922349|Secondary|AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma From Time 0 to Time of Last Quantifiable Data Point)|Area under the concentration-time curve of the analyte in plasma from time 0 to time of last quantifiable data point after a single dose of BI 113608.|0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2624626|NCT01922349|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after a single dose of BI 113608.|0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2624689|NCT01922037|Secondary|Total Number of Asthma-Related Hospital Admissions During Months 1-12||Months 1-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related hospital admissions||Standard Deviation|Mean
2624627|NCT01922349|Secondary|Tmax (Time From Dosing to Maximum Measured Concentration in Plasma)|Time from dosing to maximum measured concentration in plasma after a single dose of BI 113608.|0.25 hours (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.|||hour||Full Range|Median
2624628|NCT01922349|Secondary|Cmax (Maximum Measured Concentration of the Analyte in Plasma)|maximum measured concentration of the analyte in plasma after a single dose of BI 113608.|0.25 hours (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 71.75h after drug administration|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 secondary PK endpoint in any dose period, which was judged as PK evaluable and was not affected by important protocol violation(s) relevant to the statistical evaluation of PK endpoints.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2624629|NCT01922349|Primary|Number (%) of Subjects With Drug-related Adverse Events|Percentage of subjects with drug-related adverse events (AE) in the SRD and MRD periods combined. The investigator assessed the possible causal relationship between an AE and the trial medication.|Up to 21 days (4 days for SRD period and 17 days for MRD period)|Treated set (TS)|||Percentage of participants|||Number
2624630|NCT01922336|Secondary|Time to Cmax (Tmax)||71 days||||hour||Standard Deviation|Mean
2624631|NCT01922336|Primary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)||71 days||||h·μg/mL||Standard Deviation|Mean
2624632|NCT01922336|Primary|Maximum Serum Concentration (Cmax)||71 days||||μg/mL||Standard Deviation|Mean
2624633|NCT01922336|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)||71 days||||h·μg/mL||Standard Deviation|Mean
2624634|NCT01922271|Secondary|Inspiratory Capacity (IC)|Inspiratory Capacity (IC) is the volume of air breathed in by a maximum inspiration at the end of a normal expiration. Whole body plethysmography (Bodybox) will be used to measure IC.|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.|||Liters||Standard Deviation|Mean
2624635|NCT01922271|Secondary|Total Lung Capacity (TLC)|Total Lung Capacity (TLC) is the best vital capacity plus residual volume (RV). Whole body plethysmography (Bodybox) will be used to measure TLC.|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.|||Liters||Standard Deviation|Mean
2624636|NCT01922271|Secondary|Residual Volume (RV)|Residual Volume (RV) will be measured using whole body plethysmography (Bodybox).|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.|||Liters||Standard Deviation|Mean
2624637|NCT01922271|Secondary|Functional Resistance Capacity (FRCpleth)|Functional Resistance Capacity (FRCpleth) will be measured using whole body plethysmography (Bodybox).|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.|||Liters||Standard Deviation|Mean
2624638|NCT01922271|Secondary|Specific Airway Resistance (sRAW)|Specific Airway Resistance (sRAW) indicates volume and resistance-dependent work of breathing needed in order to generate a reference flow rate of 1 L/s, measured by kPa*s. Whole body plethysmography (Bodybox) is used to measure SRaw.|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.|||kilopascal (kPa)||Standard Deviation|Mean
2624639|NCT01922271|Secondary|Forced Expiratory Volume in One Second (FEV1) 15 Min Post Dose|Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.|||liters per hour||Standard Deviation|Mean
2624640|NCT01922271|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-2|Standardized Forced Expiratory Volume in One Second (FEV1) AUC0-2h will be measured via spirometry. The AUC will be calculated from the FEV1 measurements obtained at timepoints between 0 min and 2h using the trapezoidal rule and will be standardized (=divided) by the measurement time (i.e. 2h).|Day 1|The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period.|||liters per hour||Standard Deviation|Mean
2624641|NCT01922219|Secondary|Final Score on the Hamilton Depression Rating Scale|"Final score on the Hamilton Depression Rating Scale (HDRS) was calculated for 37 patients who were treated with Cognitive Behavioral Therapy.~The 17-item HDRS is a clinician-administered scale that quantifies depression severity, and includes items assessing mood, suicidal thinking, insomnia, feelings of guilt, work and activities, somatic symptoms, and insight. It is a well-characterized scale with excellent psychometric properties. The total score is the sum of the individual scores of the 17 scale items. Higher scores indicate greater depression severity. When using this outcome measure, we covary for baseline HDRS scores. Published norms for interpretation of the 17-item HDRS use a different version of the scale with a total possible score of 52, and are listed below. Interpretation is comparable (but not identical) with the 17-item HDRS version used in this study, which has a maximum score is 51.~None: 0-7 Mild: 8-13 Moderate: 14-19 Severe: 20-25 Very Severe: 26-52"|Post-Treatment, up to 12 weeks||||units on a scale||Standard Deviation|Mean
2624670|NCT01922037|Secondary|Percentage of Participants With Concomitant and Ongoing Asthma Medications by Category or Class of Medications|Concomitant and ongoing asthma medications were defined as all medications used for asthma which began on or after the participant's study start, as well as those ongoing at the beginning of the study. Participants received following categories or classes of concomitant and ongoing asthma medications: SABA, combination ICS/LABA, LTRA, oral/parenteral (systemic) corticosteroids, ICS, anticholinergic, LABA, and other medication.|Baseline until EOS/ET (up to Month 12)|All enrolled participants.|||percentage of participants|||Number
2624642|NCT01922219|Secondary|Post-Treatment Beck Depression Inventory|"The Beck Depression Inventory is a self-report measure of depression severity that is a well-characterized scale with excellent psychometric properties and is frequently used in research studies of depression.~The scale measures symptoms related to sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, and loss of interest in sex.~We report the total score on the BDI, which has a range of 0 to 63. Higher values represent greater severity of depression. The following score interpretations are provided in the scale's manual:~0-9 minimal depression 10-18 mild depression 19-29 moderate depression 30-63 severe depression"|Post-Treatment, up to 12 weeks||||Score on a scale||Standard Deviation|Mean
2624643|NCT01922219|Primary|Remitters as Assessed by Post-treatment Beck Depression Inventory Less Than or Equal to 10|The primary outcome of this study is remission from depression at the conclusion of 12 weeks of cognitive behavioral therapy for depression. This will be assessed using the Beck Depression Inventory, a self-report questionnaire of symptoms of depression that will be administered at every treatment visit. Remission is defined by a final Beck Depression Inventory score less than or equal to 10.|12 weeks||||Participants|||Count of Participants
2624644|NCT01922115|Primary|Hopkins Verbal Learning Test - Revised|Assesses short term verbal learning and memory. See below for the subscale delayed recognition (0-24). Percentages of total responses correct are reported for delayed recognition, higher values indicate better outcomes.|Week 4||||percentage of total correct||Standard Deviation|Mean
2624645|NCT01922115|Secondary|Overactive Bladder Questionnaire|The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument was developed and validated in both continent and incontinent OAB patients, including both men and women. Total range is 19-101 and higher values indicate worse outcomes.|Week 4||||units on a scale||Standard Deviation|Mean
2624646|NCT01922115|Secondary|Mini-Mental State Examination|The mini-mental state examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. The range is 0-30, with higher values indicating better outcomes.|Week 4||||units on a scale||Standard Deviation|Mean
2624647|NCT01922115|Primary|Hopkins Verbal Learning Test - Revised|Assesses short term verbal learning and memory. Subscales include immediate recall (0-36) and delayed recall (0-12). Higher values indicate better outcomes.|Week 4||||units on a scale||Standard Deviation|Mean
2624648|NCT01922102|Secondary|Number of Ranibizumab Injections Received in the Study Eye for the Ranibizumab Groups|To assess treatment pattern with ranibizumab|From Baseline to Month 12|Safety Set: all patients who received at least one application of study treatment & had at least one post-Baseline safety assessment. Patients were analyzed according to treatment received. One patient randomized to vPDT Group III received one ranibizumab injection prior to Month 3; this patient was analyzed under Group II in Safety Set|||Injections||Standard Deviation|Mean
2624649|NCT01922102|Secondary|NEI-VFQ-25 - Change From Baseline to Month 3, 6 and 12|The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.|Change from baseline at month 3, 6 and 12|FAS|||Composite score||Standard Deviation|Mean
2624650|NCT01922102|Secondary|Number of Patients With CNV Leakage (Center Involvement) in the Study Eye at Baseline and Month 12|CNV leakage is assessed via fluorescein angiography (center involvement) category: definite, questionable, absent, can't grade, and missing.|From Baseline until Month 12|FAS|||Participants|||Number
2624651|NCT01922102|Secondary|Mean Change From Baseline Over Time in Central Sub-field Thickness (CSFT)|Central sub-field thickness (CSFT) is a variable assessed via Optical Coherence Tomography (OCT). OCT was performed prior to any study drug administration to assess presence of intra, subretinal fluid, or increase of CSFT.|Baseline, Month 3, Month 6, and Month 12||||micrometer||Standard Deviation|Mean
2624652|NCT01922102|Secondary|Categorized BCVA Changes at Months 3, 6 and 12 Compared With Baseline for the Study Eye|ETDRS VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.|From Baseline to Month 12|FAS|||Participants|||Number
2624653|NCT01922102|Secondary|Mean Change From Baseline in Visual Acuity Over Time|Best corrected visual acuity (BCVA) was tested using the ETDRS VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.|Change from baseline at months 3, 6, and 12|FAS|||ETDRS letters||Standard Deviation|Mean
2624654|NCT01922102|Secondary|The Average Change in BCVA Score From Baseline to Month 1 Through Month 12|"Best corrected visual acuity (BCVA) was tested using the ETDRS VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.~Between treatment comparison of 0.5 mg ranibizumab intravitreal injections driven by disease activity re-treatment criteria (Group II) versus 0.5 mg ranibizumab intravitreal injections driven by visual acuity stability criteria (Group I) based on the average BCVA change from Baseline to Month 1 through Month 12"|From Baseline to Month 12|FAS, modified LOCF for comparison between ranibizumab treatment groups.|||ETDRS letters||Standard Deviation|Mean
2624686|NCT01922037|Secondary|Total Number of Asthma-Related ER Visits During Months 1-12||Months 1-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related ER visits||Standard Deviation|Mean
2624687|NCT01922037|Secondary|Total Number of Asthma-Related Hospital Admissions During Months 7-12||Months 7-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related hospital admissions||Standard Deviation|Mean
2624655|NCT01922102|Secondary|Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 6|"Best corrected visual acuity (BCVA) was tested using the early treatment diabetic retinopathy study (ETDRS) VA testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.~Between treatment comparison of 0.5 mg ranibizumab intravitreal injections driven by disease activity re-treatment criteria (Group II) versus 0.5 mg ranibizumab intravitreal injections driven by visual acuity stability criteria (Group I) based on the average BCVA change from Baseline to Month 1 through Month 6."|From Baseline to Month 6|"Full Analysis Set (FAS): Following the intent-to-treat principle, patients were analyzed according to the treatment group they were assigned to at randomization.~FAS, modified last observation carried forward (LOCF), for comparison between ranibizumab treatment groups.): consisted of all patients to whom study treatment were assigned."|||ETDRS letters||Standard Deviation|Mean
2624656|NCT01922102|Primary|Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3|Best corrected visual acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) charts testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score was calculated using the BCVA worksheet, which was kept in the source data and the score was recorded in the eCRF.|From Baseline to Month 3|Full Analysis Set (FAS): consisted of all patients to whom study treatment were assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they were assigned to at randomization.|||ETDRS letters||Standard Deviation|Mean
2624657|NCT01922089|Secondary|Number of Participants Who Tolerated Study Medication for at Least the Last Two Weeks of the Study and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low).|Tolerability was assessed as the number of participants who achieved LCZ696 200 mg bid and maintained this dose for at least 2 weeks before study completion, regardless of previous dose interruption or down-titration and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving ≤ 160 mg of valsartan or ≤ 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients)|12 weeks|Evaluable patients in FAS with the exception of misrandomized patients who didn’t received drug, but had been randomized into the study, excluding patients who discontinued the study prior to completion of 12 wks. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.|||participants|||Number
2624658|NCT01922089|Secondary|Number of Participants Who Achieved Treatment Success Over the 12 Weeks and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low)|Treatment success was defined as the number of participants who achieved and maintained LCZ696 200 mg bid without any dose interruption or down-titration over 12 weeks and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving ≤ 160 mg of valsartan or ≤ 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients)|12 weeks|Evaluable patients in FAS with the exception of misrandomized patients who didn’t received drug, but had been randomized into the study, excluding patients who discontinued the study prior to completion of 12 wks. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.|||participants|||Number
2624659|NCT01922089|Primary|Number of Participants Experiencing Hypotension, Renal Dysfunction, Hyperkalemia and Angioedema and by Renin-Angiotensin-Aldosterone System (RAAS) Stratum (High vs. Low)|Participants experiencing hypotension, renal dysfunction, hyperkalemia and angioedema and by Renin-Angiotensin-Aldosterone System (RAAS) stratum (high vs. low) High RAAS stratum Patients receiving > 160 mg of valsartan or > 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening Low RAAS stratum: Patients receiving ≤ 160 mg of valsartan or ≤ 10 mg total daily dose of enalapril, or equivalent doses of other ARBs/ACEIs, respectively, at screening. This stratum also included patients who were not on an ACEI or an ARB 4 weeks prior to screening (i.e., ACEI/ARB-naïve patients)|12 weeks|Full Analysis Set (FAS) consisted of all randomized patients with the exception of mis-randomized patients who had not received the study drug, but had been inadvertently randomized into the study. Following the intent-to-treat principle, patients were analyzed according to the treatment to which they were assigned at randomization.|||participants|||Number
2624660|NCT01922050|Secondary|Part 2: Percentage of Participants With Partial Clearance of AKs (Multiple Imputation)|"Partial clearance was defined as at least 75% reduction from baseline in AK count.~For treatment groups Vehicle, 0.006 and 0.012 the table shows the percentage of mean number of participants across imputations with partial clearance. For treatment group 0.018 the table shows the percentage of mean number of participants with partial clearance in observed cases."|At Week 8|The analysis was based on the Full Analysis Set, which was defined as all randomized participants who applied investigation product. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and thus was excluded from the efficacy analysis.|||percentage of participants||95% Confidence Interval|Number
2624661|NCT01922050|Secondary|Part 2: Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs) (Multiple Imputation)|Complete clearance was defined as a 100% reduction from baseline in AK count. For treatment groups Vehicle, 0.006 and 0.012 the table shows the percentage of mean number of participants across imputations with complete clearance. For treatment group 0.018 the table shows the percentage of mean number of participants with complete clearance in observed cases.|At Week 8|The analysis was based on the Full Analysis Set, which was defined as all randomized participants who applied investigation product. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and thus was excluded from the efficacy analysis.|||percentage of participants||95% Confidence Interval|Number
2624663|NCT01922050|Primary|Part 1: Number of Participants Experiencing a Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)|"The number of participants experiencing DLTs are tabulated by treatment group. This was used to identify the maximum tolerated dose (MTD) of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level with less than 4 out of 12 participants(cohorts 1 to 4) or less than 6 out of 18 participants(cohorts 5 and 6) experiencing a DLT~DLT was defined as one or more of the following 3 LSRs:~Crusting Grade 4~Erosion/Ulceration Grade 4~Vesiculation/Pustulation Grade 4~or two or more of the following five LSRs:~Erythema Grade 4~Crusting Grade 3~Swelling Grade 4~Erosion/Ulceration Grade 3~Vesiculation/Pustulation Grade 3~The Local Skin Responses consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category are given a numeric grade of severity from 0-4. Grade 0 being no presence and 4 being the highest grade of severity."|From Day 1 up to and including Day 8||||Participants|||Count of Participants
2624664|NCT01922037|Secondary|Change From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Quality of Life Score|The MiniRQLQ is a shorter version of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) instrument. The MiniRQLQ is a validated quality of life questionnaire to measure the functional impairments that are most troublesome to adult participants with either seasonal or perennial rhinoconjunctivitis of either allergic or non-allergic origin. The miniRQLQ contains 14 items; each item scored on a 7-point scale ranging from 0 [not impaired at all] to 6 [severely impaired]). The overall quality of life score is the average of the all item scores and ranges from 0 (not impaired at all) to 6 (severely impaired), with higher scores indicating more impairment. A negative change in score indicated improvement and a positive change indicated impairment.|Baseline, EOS/ET (up to Month 12)|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
2624665|NCT01922037|Secondary|Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using GETE by Participant|Response to treatment was assessed using the GETE. The GETE is a validated instrument that measures the overall impression of the effect of the study medication on typical asthma symptoms. The evaluation was performed using the 5-point scale. The GETE scale ranges were as follows: 1=excellent, 2=good, 3=moderate, 4=poor, 5= worsening. A good or excellent response on the 5 point scale indicated that a participant had responded to treatment. Percentage of participants who showed an improvement (GETE scale score of 1 or 2) in asthma symptoms, as assessed by participant, is reported.|EOS/ET (up to Month 12)|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percentage of participants|||Number
2624666|NCT01922037|Secondary|Percentage of Participants Who Showed an Improvement in Asthma Symptoms Due to the Medication, Assessed Using Global Evaluation of Treatment Effectiveness (GETE) by Inversigator|Response to treatment was assessed using the GETE. The GETE is a validated instrument that measures the overall impression of the effect of the study medication on typical asthma symptoms. The evaluation was performed using the 5-point scale. The GETE scale ranges were as follows: 1=excellent, 2=good, 3=moderate, 4=poor, 5= worsening. A good or excellent response on the 5 point scale indicated that a participant had responded to treatment. Percentage of participants who showed an improvement (GETE scale score of 1 or 2) in asthma symptoms, as assessed by investigator, is reported.|EOS/ET (up to Month 12)|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percentage of participants|||Number
2624667|NCT01922037|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score|WPAI-asthma is a self-administered instrument to measure asthma-specific performance impairment of work and regular daily activity within the last 7 days and yields 4 types of scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (WI) (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Total score and each score ranged from 0 (not affected/no impairment) to 100 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. A negative change in score indicated improvement and a positive change indicated impairment.|Baseline, Month 6, EOS/ET (up to Month 12)|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
2624668|NCT01922037|Secondary|Change From Baseline in Asthma Control Test (ACT) Overall Score|Multidimensional factors associated with asthma control from the participant's perspective were assessed using the ACT questionnaire. The ACT is a validated, five-item patient-reported outcome (PRO) questionnaire that measures the impact of asthma on home and work activities, shortness of breath, symptoms, rescue medication usage, and overall asthma control. All items are scored on a 5-point likert scale (1 to 5). All item scores are added together to calculate a total score. Total score ranges from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. A positive change from baseline indicated improvement.|Baseline, Months 3, 6, 9, 12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
2624669|NCT01922037|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12) Overall Score|AQLQ +12 is a 32-item disease specific questionnaire designed to assess the participants' asthma-specific health-related quality of life (QOL). The questionnaire contains four domains: activity limitations (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). All items are scored on a 7-point likert scale. All item scores are averaged to produce one overall QOL score. Overall score ranges from 1 (total impairment) to 7 (no impairment), with higher scores indicating better QOL. A positive change from baseline indicated improved QOL.|Baseline, Month 6, EOS/ET (up to Month 12)|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
2624688|NCT01922037|Secondary|Total Number of Asthma-Related Hospital Admissions During Months 1-6||Months 1-6|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related hospital admissions||Standard Deviation|Mean
2624671|NCT01922037|Secondary|Percentage of Participants With Prior Asthma Medications by Category or Class of Medications|Prior asthma medications were defined as all medications used for asthma prior to the study (initiated within 90 days of baseline) and were assessed retrospectively at baseline. Participants received prior asthma medications of following categories or classes: short acting beta agonist (SABA), combination inhaled corticosteroids/long acting beta agonist (ICS/LABA), leukotriene receptor antagonist (LTRA), inhaled corticosteroids (ICS), oral/parenteral (systemic) corticosteroids, anticholinergic, long acting beta agonist (LABA), and other medication.|Baseline|All enrolled participants.|||percentage of participants|||Number
2624672|NCT01922037|Secondary|Change From Baseline in Percentage Predicted FEV1 (ppFEV1)|FEV1 is the volume of air that can be forced out in one second after taking a deep breath, as measured using spirometry. Hankinson and Wang standards were used to calculate ppFEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. ppFEV1= 100 multiplied by (*) FEV1 (in liters [L]) divided by (/) predicted FEV1 (in L). Pre-bronchodilator ppFEV1 and post-bronchodilator ppFEV1 are reported for each timepoint.|Baseline, Month 6, EOS/ET (up to Month 12)|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.|||percentage of predicted FEV1||Standard Deviation|Mean
2624673|NCT01922037|Secondary|Change From Baseline in Raw Forced Expiratory Flow at 25-75 Percent (%) of Pulmonary Volume (FEF25%−75%)|FEF25%-75% was defined as the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. Pre-bronchodilator FEF25%-75% and post-bronchodilator FEF25%-75% are reported for each timepoint. FEF25%-75% was measured using spirometry.|Baseline, Month 6, EOS/ET (up to Month 12)|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.|||liters per second||Standard Deviation|Mean
2624674|NCT01922037|Secondary|Change From Baseline in Raw Forced Vital Capacity (FVC)|FVC was defined as the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pre-bronchodilator FVC and post-bronchodilator FVC are reported for each timepoint. FVC was measured using spirometry.|Baseline, Month 6, EOS/ET (up to Month 12)|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.|||liters||Standard Deviation|Mean
2624675|NCT01922037|Secondary|Change From Baseline in Raw Forced Expiratory Volume in One Second (FEV1)|FEV1 was defined as the volume of air that can be forced out in one second after taking a deep breath. Pre-bronchodilator FEV1 and post-bronchodilator FEV1 are reported for each timepoint. FEV1 was measured using spirometry.|Baseline, Month 6, end of study (EOS)/early termination (ET) (up to Month 12)|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure. Here, number analyzed=participants evaluable for this outcome measure at specified timepoint.|||liters||Standard Deviation|Mean
2624676|NCT01922037|Secondary|Percentage of Participants by Number of Asthma Exacerbations Requiring Treatment With Systemic Steroids|Percentage of participants by number of asthma exacerbations (0, 1, 2, 3, >/=4) requiring treatment with systemic steroids was reported. An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.|Months 1-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percentage of participants|||Number
2624677|NCT01922037|Secondary|Percentage of Participants by Number of Asthma Exacerbations|Percentage of participants by number of asthma exacerbations (0, 1, 2, 3, >/=4) was reported. An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.|Months 1-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percentage of participants|||Number
2624678|NCT01922037|Secondary|Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 7-12||Months 7-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related telephone calls||Standard Deviation|Mean
2624679|NCT01922037|Secondary|Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-6||Months 1-6|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related telephone calls||Standard Deviation|Mean
2624680|NCT01922037|Secondary|Total Number of Asthma-Related Telephone Calls to Healthcare Providers During Months 1-12||Months 1-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related telephone calls||Standard Deviation|Mean
2624681|NCT01922037|Secondary|Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 7-12||Months 7-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related physician's office visits||Standard Deviation|Mean
2624682|NCT01922037|Secondary|Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-6||Months 1-6|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related physician's office visits||Standard Deviation|Mean
2624683|NCT01922037|Secondary|Total Number of Asthma-Related Unscheduled Physician's Office Visits During Months 1-12||Months 1-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related physician's office visits||Standard Deviation|Mean
2624684|NCT01922037|Secondary|Total Number of Asthma-Related ER Visits During Months 7-12||Months 7-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related ER visits||Standard Deviation|Mean
2624685|NCT01922037|Secondary|Total Number of Asthma-Related Emergency Room (ER) Visits During Months 1-6||Months 1-6|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma-related ER visits||Standard Deviation|Mean
2624690|NCT01922037|Secondary|Total Number of Asthma Exacerbations During Months 7-12|An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.|Months 7-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma exacerbations||Standard Deviation|Mean
2624691|NCT01922037|Secondary|Total Number of Asthma Exacerbations During Months 1-6|An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/=3 days.|Months 1-6|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma exacerbations||Standard Deviation|Mean
2624692|NCT01922037|Primary|Total Number of Asthma Exacerbations During Months 1-12|An asthma exacerbation was defined as new or increased asthma symptoms which resulted in either hospitalization and/or treatment with systemic corticosteroids (or increase of stable maintenance dose) for >/= 3 days.|Months 1-12|All enrolled participants. Overall number of participants analyzed=participants evaluable for this outcome measure.|||asthma exacerbations||Standard Deviation|Mean
2624693|NCT01922024|Primary|Clinical Sensitivity and Specificity for Microorganism Detection as Compared to Routine Microbiology and Other Reference Methods Including PCR and Sequencing|Sensitivity for microorganism detection will be determined against the respective reference method consisting of standard procedure and/or a reference method based on PCR and bi-directional sequencing using alternative primers. Sensitivity for non-atypical microorganism detection will thus be determined if at least 1 out of 2 reference methods have identified microorganisms that are covered by the panel of the investigational IVD. Results will further be analyzed against standard of-care alone, as well as against composite comparator. Sensitivity for atypical microorganism detection will be determined against PCR with alternative primers as reference method. Specificity for microorganism detection will be determined in all samples included in the trial. Individual specificities will be calculated for the detection of the respiratory microorganisms analyzed by the investigational IVD compared to the microorganisms reference method.|Up to 12 months||||Percentage||95% Confidence Interval|Mean
2624694|NCT01922011|Other Pre-specified|Plasma Concentration of Daptomycin at 4 to 5 Hours After the End of IV Infusion|Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42|Day 3 up to Day 42|Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed.|||µg/mL||Standard Deviation|Mean
2624695|NCT01922011|Other Pre-specified|Plasma Concentration of Daptomycin at 2 to 3 Hours After the End of IV Infusion|Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42|Day 3 up to Day 42|Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed.|||µg/mL||Standard Deviation|Mean
2624696|NCT01922011|Other Pre-specified|Plasma Concentration of Daptomycin at 15 Minutes to 1 Hour After the End of IV Infusion|Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42|Day 3 up to Day 42|Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed.|||µg/mL||Standard Deviation|Mean
2624697|NCT01922011|Other Pre-specified|Plasma Concentration of Daptomycin at the End of IV Infusion|Blood samples were collected, after infusion of IV study drug between the end of infusion on study day 3, up to Day 42|Day 3 up to Day 42|Participants who received a known amount of daptomycin and who had at least one blood sample collected. Participants treated with vancomycin, nafcillin or equivalent were not analyzed.|||µg/mL||Standard Deviation|Mean
2624698|NCT01922011|Other Pre-specified|Change From Baseline in Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments|Focused neurological examinations include assessments of alertness, sensation, pupillary reflex and tracking, peripheral reflexes (biceps, patellar tendon, ankle jerk, and plantar response), muscle tone and strength (upper and lower limbs), coordination (finger to nose), and tremor of the hands/fingers.|Baseline and up to Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)|Data were only summarized for each visit; but not analyzed.||||||
2624699|NCT01922011|Other Pre-specified|Concentration of Serum Creatine Kinase (CK)|Serum was collected at Baseline and at End of Therapy IV, from which the concentration of CK was determined.|Baseline and End of Therapy IV (up to Day 42)|Treated participants based on the treatment received|||U/L||Standard Deviation|Mean
2624700|NCT01922011|Other Pre-specified|Number of Participants With 1 or More Serious Adverse Events (SAEs)|An SAE is any untoward medical occurrence that at any dose results in death; is life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect.|Administration of first dose through the last follow-up visit; an expected time of up to 6.5 months|Treated participants based on the treatment received|||Participants|||Number
2624701|NCT01922011|Other Pre-specified|Number of Participants With 1 or More Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, clinically significant laboratory finding, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product|Administration of first dose up to approximately six and a half months after last dose of study drug|Treated participants based on the treatment received|||Participants|||Number
2624708|NCT01921894|Primary|Number of Participants With Vitamin D Sufficiency (Vitamin D ≥30 ng/ml) After 4 Weeks of Supplementation|The outcome is defined as the number of participants with a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation|4 weeks|The characteristics of the study population are the same as described for the other primary outcome (vitamin D sufficiency at 8 weeks)|||participants|||Number
2624709|NCT01921894|Secondary|Number of Participants With FEV1 < 80% of Predicted|Forced expiratory volume in 1 second (FEV1) as percent predicted (with reference values used according to the child's age, gender and ethnicity).|8 weeks|We wanted to compare the proportion of subjects whose FEV1 % predicted fell below 80% predicted across the three arms in this pilot Phase I study.|||participants|||Number
2624702|NCT01922011|Secondary|Percentage of Participants With a Favorable Microbiological Response Categorized by Baseline Pathogen at Test of Cure|Favorable microbiological outcomes are either eradication where the source specimen demonstrated absence of the original baseline pathogen; or presumed eradication where the source specimen was not available to culture, and the subject was assessed as a clinical cure. For a favorable microbiological response, the outcome for each baseline pathogen must be eradicated or presumed eradicated. Other pathogens include Arcanobacterium haemolyticum, Gram positive cocci, Staphylococcus epidermidis, Streptococcus dysgalactiae, Streptococcus mitis group and Streptococcus pyogenes.|Baseline (within 48 hours prior to first dose of IV study drug) - and Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)|All randomized participants who received IV study drug and had a confirmed diagnosis of AHO, excluding participants with confirmed culture of a gram-negative organism; but including those where at least one bacterial pathogen was isolated from an appropriate microbiological specimen at baseline.|||Percentage of participants||95% Confidence Interval|Number
2624703|NCT01922011|Secondary|Percentage of Participants With Sustained Clinical Improvement|Sustained clinical improvement was defined as participants with clinical improvement who further met the definition of clinical cure. Clinical improvement was in the three general categories of Pain, Inflammation, and Limb Function on or before Study Day 5. Clinical cure is defined as resolution of all acute symptoms of AHO or improvement to such an extent that no further intravenous antibacterial therapy is required. The EOT visit is within 48 hours of last dose of PO therapy.|Baseline (within 48 hours prior to first dose of IV study drug) - up to Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)|All randomized participants who received any amount of IV study drug and who had a confirmed or suspected diagnosis of AHO, excluding those with confirmed culture of a gram-negative organism from any baseline specimen; and had non-missing clinical outcome.|||Percentage of participants||95% Confidence Interval|Number
2624704|NCT01922011|Secondary|Percentage of Participants With a Clinical Cure Categorized by Baseline Pathogen at Test of Cure|At Test Of Cure (TOC) clinical cure is defined as resolution of all acute symptoms of AHO or improvement to such an extent that no further antibacterial therapy is required. Favorable microbiological outcomes are either eradication where the source specimen demonstrated absence of the original baseline pathogen; or presumed eradication where the source specimen was not available to culture, and the subject was assessed as a clinical cure. To have a favorable microbiological response, the outcome for each participant's baseline pathogen must be favorable (eradicated or presumed eradicated). Other pathogens include Arcanobacterium haemolyticum, Gram positive cocci, Staphylococcus epidermidis, Streptococcus dysgalactiae, Streptococcus mitis group and Streptococcus pyogenes.|Baseline (within 48 hours prior to first dose of IV study drug) - and Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)|All randomized participants who received IV study drug and had a confirmed diagnosis of AHO, excluding participants with confirmed culture of a gram-negative organism; but including those where at least one bacterial pathogen was isolated from an appropriate microbiological specimen at baseline.|||Percentage of participants||95% Confidence Interval|Number
2624705|NCT01922011|Secondary|Percentage of Participants With a Favorable Clinical Outcome|Favorable clinical outcomes are clinical recovery and clinical cure. Clinical cure is defined as resolution of all acute symptoms of AHO or improvement to such an extent that no further intravenous antibacterial therapy is required. Clinical recovery is defined as clinical improvement in the composite end point three general categories of Pain, Inflammation, and Limb Function on or before Study Day 5, and no development of new symptoms of AHO; body temperature ≤ 38°C (100.4°F) for 24 hours; no new or additional bone or joint infection (e.g., abscess, spreading to other osseous or articular locations) such that no further antibacterial therapy or surgery are required; no hematogenous metastatic infection (e.g., abscess in liver, spleen, lung; other bones) or bacteremia.. The End of Therapy (EOT) visit is within 48 hours of last dose of PO therapy.|Baseline (within 48 hours prior to first dose of IV study drug) - and up to Test of Cure (21-35 days after last dose of IV study drug) (up to Day 77)|All randomized participants who received any amount of IV study drug and who had a confirmed diagnosis of AHO (Categories I, II and III), excluding participants with confirmed culture of a gram-negative organism from any baseline specimen|||Percentage of participants||95% Confidence Interval|Number
2624706|NCT01922011|Secondary|Percentage of Participants With Clinical Improvement Measured as a Composite End Point of Pain, Inflammation, Limb Function, Body Temperature, and C-reactive Protein at End-of IV (EOIV) Therapy Visit.|A participant had a favorable outcome in this composite endpoint if all 3 of the following criteria were met: Clinical improvement in the general symptom categories of Pain, Inflammation, and Limb Function on or before Study Day 5; Body temperature ≤ 38°C (100.4°F) over the preceding 24 hours; and C-reactive Protein (CRP) decreased from baseline for participants who had a baseline CRP >ULN (upper limit of normal)) or remain <=ULN for participants who had a baseline <=ULN on or before Study Day 5. The EOIV visit is within 24 hours after the last dose of IV study drug and before switch to optional open label (PO) therapy, if applicable.|Up to study Day 5|All randomized participants who received any amount of IV study drug and who had a confirmed diagnosis of AHO (Categories I, II and III), excluding participants with confirmed culture of a gram-negative organism from any baseline specimen and who did not have all clinical assessments performed at the time point.|||Percentage of participants||95% Confidence Interval|Number
2624707|NCT01922011|Primary|Percentage of Participants With Clinical Improvement in the 3 General Categories of Pain, Inflammation, and Limb Function Based on the Investigator's Overall Assessment of Severity of Each of the Symptom Categories.|Clinical improvement was based on the Investigator's overall assessment of severity of each of the 3 general symptom categories of Pain, Inflammation, and Limb Function. Based on this evaluation, a participant was considered to have met criteria for clinical improvement according to the following definition: If 3 general categories are present at baseline: at least a 1-point improvement (i.e. severe to moderate, moderate to mild, mild to absent) in at least 2 of the general categories and no worsening in the other. If 2 general categories are present at baseline: at least a 2-point improvement (i.e. severe to mild, moderate to absent) in at least 1 of the general categories and no worsening or new findings in the others OR at least a 1-point improvement in both and no new findings in the other. If 1 general category is present at baseline: at least a 2-point improvement (i.e., severe to mild, moderate to absent) in that category and no new findings in the others.|Up to study Day 5|All randomized participants who received any amount of IV study drug and who had a confirmed or suspected diagnosis of AHO, excluding those with confirmed culture of a gram-negative organism from any baseline specimen.|||Percentage of participants||95% Confidence Interval|Number
2624710|NCT01921894|Secondary|Number of Participants With Elevated Urinary Calcium/Creatinine Ratio|Elevated urinary calcium/creatinine ratio defined as UCa/UCr > 0.37 after either 4 weeks or 8 weeks of supplementation|4 and/or 8 weeks|We wanted to compare the proportion of subjects who had an elevated UCa/UCr ratio across the three groups in this pilot Phase I Study|||participants|||Number
2624711|NCT01921894|Secondary|Number of Participants With Vitamin D Toxicity|Participants with vitamin D toxicity, hypercalcemia (>10.8mg/dl) and/or an elevated urine Ca/Cr ratio (>0.37)|8 weeks|We wanted to report and compare the proportion of subjects who had vitamin D toxicity, hypercalcemia or an elevated UCa/UCr ratio across the three treatment arms|||participants|||Number
2624712|NCT01921894|Primary|Number of Participants With Sufficient Vitamin D Levels (≥30 ng/ml) After 8 Weeks of Supplementation|The primary outcome of the proposed trial will be a sufficient (≥30 ng/ml) vitamin D level after 8 weeks of supplementation|8 weeks|In this pilot study, we wanted to report and compare the proportion of subjects who achieved vitamin D sufficiency after 8 weeks of treatment with one of three vitamin D doses.|||participants|||Number
2624713|NCT01921829|Other Pre-specified|Adverse Events|Hypokalemia (K <3.0 milliequivalents (mEq)/L), hypotension (systolic BP <90 mmHg), hyponatremia (Na <130 mEq/L), arrhythmias, cramps, and other (recorded as short description).|Daily while in hospital , 1 mo, & 3 mos||||events||Standard Deviation|Mean
2624714|NCT01921829|Secondary|PSQI Total Score Change at 3 Months|The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Traditionally, the items from the PSQI have been summed to create a total score to measure overall sleep quality.|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
2624715|NCT01921829|Secondary|PHQ-9 Depression Index Change at 3 Months|"The Patient Health Questionnaire (PHQ-9) Depression Index is a well-established index of depression and has been validated in many patient populations. Its scoring ranges from 0-27 with increasing scores representing increasing depression severity. Score categories determine depression severity and recommended management:~0-4 - Minimal or none. Monitor; may not require treatment. 5-9 - Mild. Use clinical judgment (symptom duration, functional impairment) to determine necessity of treatment.~10-14 - Moderate. Use clinical judgment (symptom duration, functional impairment) to determine necessity of treatment.~15-19 - Moderately severe. Warrants active treatment with psychotherapy, medications, or combination.~20-27 - Severe. Warrants active treatment with psychotherapy, medications, or combination."|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
2624716|NCT01921829|Secondary|SF-36 Physical Component Score (PCS) Change at 3 Months|The Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36) is a well-validated generic HRQOL questionnaire that generates two composite scores: the Physical Component Score (PCS) and Mental Component Score (MCS). The PCS aggregates items from Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, and Social Functioning. The MCS aggregates items from Role-Emotional, Mental Health, General Health, Vitality, and Social Functioning. The mean for each summary scale is 50 points with standard deviation of 10 points. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
2624717|NCT01921829|Secondary|SF-36 Mental Component Score (MCS) Change at 3 Months|The Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36) is a well-validated generic HRQOL questionnaire that generates two composite scores: the Physical Component Score (PCS) and Mental Component Score (MCS). The PCS aggregates items from Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, and Social Functioning. The MCS aggregates items from Role-Emotional, Mental Health, General Health, Vitality, and Social Functioning. The mean for each summary scale is 50 points with standard deviation of 10 points. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
2624718|NCT01921829|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score Change at 3 Months|The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A mean difference over time of 5 points on the KCCQ Overall Summary Scale reflects a clinically significant change in heart failure status. A 10 point decline in KCCQ scores has important prognostic significance in terms of survival.|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
2624727|NCT01921829|Secondary|Fluid Balance|Strict intake (oral intake, intravenous medications, fluids, etc.) and output (urine, emesis, stools, drains, etc.) will be documented by the nurses on the HF floors per routine clinical protocol for all patients. Fluid balance will be determined by subtracting the volume of total intake from the volume of total output (in mL) over 24 hours (7 am to 7 am or the preceding 24-h period if no 7 am to 7 am period is available). Fluid balance and urine output will be ascertained by chart review daily during the intervention while the participants are hospitalized.|Daily while in hospital||||mL/day||Standard Deviation|Mean
2624719|NCT01921829|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Score Change at 3 Months|The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A mean difference over time of 5 points on the KCCQ Overall Summary Scale reflects a clinically significant change in heart failure status. A 10 point decline in KCCQ scores has important prognostic significance in terms of survival.|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
2624720|NCT01921829|Secondary|PSQI Total Score Change at 1 Month|The Pittsburgh Sleep Quality Index (PSQI) is the most widely used global sleep assessment and has been studied in the renal transplant population. Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Traditionally, the items from the PSQI have been summed to create a total score to measure overall sleep quality.|Baseline to 1 month||||units on a scale||Standard Deviation|Mean
2624721|NCT01921829|Secondary|PHQ-9 Depression Index Change at 1 Month|"The Patient Health Questionnaire (PHQ-9) Depression Index is a well-established index of depression and has been validated in many patient populations. Its scores range from 0-27 with increasing scores representing increasing depression severity. Score categories represent depression severity and management recommendations:~0-4 - Minimal or no depression. Monitor; may not require treatment. 5-9 - Mild. Use clinical judgment (symptom duration, functional impairment) to determine necessity of treatment.~10-14 - Moderate. Use clinical judgment (symptom duration, functional impairment) to determine necessity of treatment.~15-19 - Moderately severe. Warrants active treatment with psychotherapy, medications, or combination.~20-27 - Severe. Warrants active treatment with psychotherapy, medications, or combination."|Baseline to 1 month||||units on a scale||Standard Deviation|Mean
2624722|NCT01921829|Secondary|SF-36 Physical Component Score (PCS) Change at 1 Month|The Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36) is a well-validated generic HRQOL questionnaire that generates two composite scores: the Physical Component Score (PCS) and Mental Component Score (MCS). The PCS aggregates items from Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, and Social Functioning. The MCS aggregates items from Role-Emotional, Mental Health, General Health, Vitality, and Social Functioning. The mean for each summary scale is 50 points with standard deviation of 10 points. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Baseline to 1 month||||units on a scale||Standard Deviation|Mean
2624723|NCT01921829|Secondary|SF-36 Mental Component Score (MCS) Change at 1 Month|The Medical Outcomes Study (MOS) 36-item Short-Form Health Survey (SF-36) is a well-validated generic HRQOL questionnaire that generates two composite scores: the Physical Component Score (PCS) and Mental Component Score (MCS). The PCS aggregates items from Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, and Social Functioning. The MCS aggregates items from Role-Emotional, Mental Health, General Health, Vitality, and Social Functioning. The mean for each summary scale is 50 points with standard deviation of 10 points. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Baseline to 1 month||||units on a scale||Standard Deviation|Mean
2624724|NCT01921829|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score Change at 1 Month|The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A mean difference over time of 5 points on the KCCQ Overall Summary Scale reflects a clinically significant change in heart failure status. A 10 point decline in KCCQ scores has important prognostic significance in terms of survival.|Baseline to 1 month||||units on a scale||Standard Deviation|Mean
2624725|NCT01921829|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Score Change at 1 Month|The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a well-validated 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A mean difference over time of 5 points on the KCCQ Overall Summary Scale reflects a clinically significant change in heart failure status. A 10 point decline in KCCQ scores has important prognostic significance in terms of survival.|Baseline to 1 month||||units on a scale||Standard Deviation|Mean
2624726|NCT01921829|Secondary|Acute Kidney Injury|Acute kidney injury will be defined based a rise in Cr ≥0.3 mg/dL.|Daily while in hospital, 1 mo & 3 mos||||Participants|||Count of Participants
2625278|NCT01913795|Secondary|Lung Function|peak expiratory flow (PEF)|measured at baseline and months 6 and 12|The number of participants analyzed here excludes participants for whom follow-up for health outcomes was incomplete.|||Liters/second||Standard Error|Mean
2624728|NCT01921829|Secondary|Difference From Baseline to 1 Month in Change in Right Internal Jugular Vein (RIJV) Cross-sectional Area (CSA) Pre- and Post-Valsalva|The change in cross-sectional area (CSA) of the right internal jugular vein (RIJV) pre- and post-Valsalva is a measurement of venous compliance and was determined noninvasively with Doppler ultrasound. An increase in RIJV CSA >17% during Valsalva effectively rules out elevated right atrial pressure (RAP) and suggests effective volume removal or decongestion. The difference between baseline and 1 month values of change in RIJV CSA are reported.|Up to 1 month (measured at baseline and 1 mo)||||cm^2||Standard Deviation|Mean
2624729|NCT01921829|Secondary|All-cause Mortality|All-cause mortality will be ascertained based on chart review of vital status (alive/dead) and cause of death.|Up to 3 months (assessed at 1 month and 3 months)||||Participants|||Count of Participants
2624730|NCT01921829|Secondary|Number of Total Rehospitalizations|Number of rehospitalizations will be ascertained based on chart review of admissions to any hospital after the index hospitalization|Up to 3 months (assessed at 1 month and 3 months)||||hospitalizations||Standard Deviation|Mean
2624731|NCT01921829|Secondary|Number of Rehospitalizations for Heart Failure (HF)|Number of rehospitalizations for HF will be ascertained based on chart review of admissions with HF as a coded diagnosis, evidence of clinical volume overload, and treatment with intravenous diuretics.|Up to 3 months (assessed at 1 month and 3 months)||||hospitalizations|||Number
2624732|NCT01921829|Secondary|Length of Hospitalization|Length of hospitalization will be ascertained from admission date to date of discharge.|1 month|One participant from the ProDiuS arm withdrew consent before undergoing any randomized treatment.|||days||Standard Deviation|Mean
2624733|NCT01921829|Primary|Change in Body Weight (kg) From Randomization to Day 4 or Date of Discharge (Whichever Comes First)|The change in body weight (kg) from randomization to day 4 or date of discharge will be determined by the difference between body weight at day 4 after randomization or date of discharge (whichever comes first) and body weight taken at baseline measured in the hospital on standard scales without shoes and wearing a hospital gown, measured before breakfast and post-voiding.|4 days (96 hours)|One patient from ProDiuS arm withdrew before undergoing any randomized treatment.|||kg||Standard Deviation|Mean
2624734|NCT01921751|Secondary|Correlation Between SMAD4 Status Determined by Immunohistochemistry (IHC) and Genetic SMAD4 Status||Baseline|Because the study was terminated early, genetic SMAD4 status was not determined and therefore this analysis will not occur.||||||
2624735|NCT01921751|Secondary|Patterns of Failure (Local and Metastatic Failure)|Local progression is defined as least a 20% increase in the sum of diameters of the primary, taking as reference the baseline sum. Given the inherent inaccuracy in determining size of a primary pancreatic carcinoma, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and progression must be demonstrated on at least two sequential scans. Metastatic failure is defined as metastatic disease. Local and distant failure were to be estimated by the cumulative incidence method. Given the limited follow-up due to early closure and termination of data collection, only the number of patients with failure is reported.|From randomization until last follow-up. Maximum follow-up at time of study termination was 8.3 months.|Randomized eligible patients with follow-up data.|||Participants|||Count of Participants
2624736|NCT01921751|Secondary|Overall Survival Within SMAD4 Subsets|"Survival time is defined as time from randomization to date of death from any cause and was to be estimated by the Kaplan-Meier method. Given the limited follow-up due to early closure and termination of data collection, only the number of patients last reported to be alive at time of study termination is reported. Patients are categorized by SMAD4 status of intact (positive nuclear labeling is observed of the neoplastic cells ), loss (no labeling observed of the neoplastic cells) , or undetermined (insufficient material for immunostaining or results are equivocal). This study terminated early with only 20 registered (346 planned) and 13 randomized (288 planned). There are no proven results as to which category has better incomes, but this study hypothesizes that intact is highly correlated with local failures and loss is highly correlated with widespread metastasis, in which case intact would correspond with positive results relative to loss."|From randomization until last follow-up. Analysis was to occur after a total of 140 deaths were reported within the pairing of each radiation arm with the chemotherapy alone arm. Maximum follow-up at time of study termination was 8.3 months.|All randomized patients|||Participants|||Count of Participants
2624737|NCT01921751|Primary|Overall Survival|Survival time is defined as time from randomization to date of death from any cause and was to be estimated by the Kaplan-Meier method. Given the limited follow-up due to early closure and termination of data collection, only the number of patients last reported to be alive at time of study termination is reported.|From randomization until last follow-up. Analysis was to occur after a total of 140 deaths were reported within the pairing of each radiation arm with the chemotherapy alone arm. Maximum follow-up at time of study termination was 8.3 months.|All randomized patients|||Participants|||Count of Participants
2624738|NCT01921517|Primary|Change in Distal Tibia Bone Quality|Distal tibial bone quality is measured through MRI by calculating the ratio between bone volume to total volume. A lower value would indicate osteoporotic (weaker) bone; a higher value would indicate healthy (normal) bone.|Baseline to 12 months||||percentage of change||80% Confidence Interval|Mean
2624739|NCT01921452|Primary|Concentration of TSH in Whole Blood||Day 1 up to Day 5|The FAS included all enrolled participants.|||Milli international units per liter||Standard Deviation|Mean
2624740|NCT01921452|Primary|Number of Participants With Positive and Negative TSH Test Result||Day 1 up to Day 5|The FAS included all enrolled participants. ‘n’ signifies number of participants who were evaluable for this measure for the specified category.|||Participants|||Number
2624741|NCT01921387|Secondary|The Lowest Antibody (Yttrium 90-BC8-DOTA) Dose (mg/kg) That is Consistent With a Favorable Biodistribution Rate >= 80% in Lymphoma Patients||Up to 5 years||||mg/kg|||Number
2624742|NCT01921387|Secondary|Estimated Dose to Tumor Sites Based on the Tumor to Normal Organ Ratios Derived From Dosimetry Estimates Coupled With the Absorbed Dose to Normal Organs Based on the Administered Activity of Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8|Will be evaluated among all patients and among those treated at the estimated MTD.|Up to 5 years||||mCi|||Number
2624743|NCT01921387|Primary|Progression-free Survival Following Autologous Stem Cell Transplant (ASCT)|Estimate the 1 year progression-free survival (PFS) rate after ASCT|1 year||||Participants|||Count of Participants
2624744|NCT01921387|Primary|Maximum-tolerated Dose (MTD) of Yttrium-90-BC8-DOTA|Single patients will be treated at escalating doses in 2-Gy increments (Table 4) until a DLT is observed. Once a DLT is observed, the second stage will begin at the next lower dose level and patients will be treated in cohorts of 4.|Within 30 days post-transplant||||Gy - MTD|||Number
2624745|NCT01921348|Other Pre-specified|Immune Biomarkers|Changes in Regulatory T(Treg), Type 1 Regulatory T (Tr1), T helper 3(TH3), T helper 1(TH1), T helper 2(TH2)cells, salivary cortisol, alpha amylase, Interferon gamma(IFNg), Interleukin 4(IL4) and Interleukin 10(IL10) cytokine production from baseline to 8 weeks.|8 weeks|Blood samples were collected and frozen for batch analysis, but not analyzed for data since recruitment goals were not met.||||||
2624746|NCT01921348|Secondary|Psychological Measures|Effects of ear acupressure on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry.|8 weeks|Since the immune biomarker frozen blood samples were not analyzed (due to not meeting recruitment goals), the effects of ear accupressure based upon psychological differences could not be analyzed.||||||
2624747|NCT01921348|Primary|Rhinoconjunctivitis Quality of Life Questionnaire (Nasal Symptoms Domain Only)|"RQLQ is an instrument that has 28 items in 7 domains (sleep, non-rhinoconjuctivitis symptoms, practical problems, nasal symptoms, eye symptoms activity limitations and emotional function). Participants are asked to recall impairments experienced during the previous week and to respond to each item on a 7-point scale (0=no impairment; 6=maximum impairment).~In this protocol, we used the nasal symptoms domain only; 4 questions, total scale ranges from 0 minimum to 24 maximum.~Longitudinal changes of nasal symptoms domain total were reported from baseline to 8 weeks."|8 weeks|Enrollment targets were not met for both arms/groups.|||units on a scale||Standard Deviation|Mean
2624748|NCT01921322|Secondary|Glycemic Variability|Glycemic variability (mean amplitude glycemic excursion) using CGM as reference method|Up to 14 days in hospital|subjects incluced in final analysis|||mmol/L||Standard Deviation|Mean
2624749|NCT01921322|Primary|Time to Target|length of time to achieve target glucose range using Self-Monitoring Blood Glucose (SMBG), as reference method, with the 722 Paradigm Real-Time insulin pump versus Multiple Daily Injection|Up to 14 days in hospital|subjects included in final analysis|||days||Standard Deviation|Mean
2624750|NCT01921296|Other Pre-specified|Percentage of Patients That Experience Adverse Events|Persistence with cyclobenzaprine therapy for 24 weeks will be assessed using a medication diary. Safety will be assessed using CTCAE criteria|24 weeks||||percentage of participants|||Number
2624751|NCT01921296|Other Pre-specified|Percentage of Subjects Who Continue to Take Aromatase Inhibitor Therapy|We will assess the number of patients who continue to take the original aromatase inhibitor medication at the 24 week timepoint, as assessed using patient self-report and medical records|24 weeks||||percentage of participants|||Number
2624752|NCT01921296|Secondary|Change in Average Pain Between Baseline and Week 8 With Cyclobenzaprine Therapy|Will measure average pain using the Brief Pain Inventory at baseline and after 8 weeks of therapy with cyclobenzaprine. On the Brief Pain Inventory, average pain is reported using a 0-10 scale, with higher numbers reflecting more pain. Change is calculated by subtracting pain at baseline is from pain at 8 weeks. A positive value represents an increase in pain.|baseline and 8 weeks|Only one of the two enrolled participants completed questionnaires after the baseline assessment|||change in average pain||Full Range|Mean
2624753|NCT01921296|Secondary|Change in Fatigue Between Baseline and Week 8 With Cyclobenzaprine Therapy|Will measure fatigue using the PROMIS fatigue questionnaire at baseline and after 8 weeks of therapy with cyclobenzaprine. The PROMIS Fatigue 7a score was calculated according to the information provided on the website. The raw score ranges from 7-35. The raw score is then converted to a T score according to the instruction on the website, with higher scores representing more fatigue. The T score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. The change in fatigue is calculated by subtracting the T score at baseline from the T score at 8 weeks. Positive values represent worsening of fatigue.|baseline and 8 weeks|Only one of the two enrolled participants completed questionnaires after the baseline assessment|||change in T score||Full Range|Mean
2624754|NCT01921296|Primary|Number of Patients That Experience an Improvement in Sleep Quality as Assessed Using the Pittsburgh Sleep Quality Index (PSQI) With 8 Weeks of Cyclobenzaprine Therapy.|Will measure sleep quality using the Pittsburgh Sleep Quality Index at baseline and after 8 weeks of therapy with cyclobenzaprine. A total score is calculated for the Pittsburgh Sleep Quality Index. The total score ranges from 0-21, with higher scores representing worse sleep quality. Any reduction in PSQI total score was considered an improvement.|8 weeks|Only one of the two enrolled participants completed questionnaires after the baseline assessment|||participant|||Number
2624755|NCT01921270|Secondary|Mean Unified Dystonia Rating Scale (UDRS) Score as Measured by Blinded Rater|The UDRS measures dystonia severity. The UDRS is being rated by blinded video evaluators regarding severity of subject's dystonia. Scores range from 0 to 10; 0 indicating no dystonia, 5 indicating moderate dystonia, and 10 indicating the worst dystonia.|Baseline, Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
2624756|NCT01921270|Secondary|Mean Global Dystonia Rating Scale Score as Measured by Un-blinded Rater|"This scale measures the severity of dystonia for the jaw and tongue by an un-blinded rater. Dystonia is rated from 0 to 10:~0=No dystonia present, 1=Minimal dystonia, 5=Moderate dystonia,10=Most severe dystonia"|Baseline, Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
2624777|NCT01921205|Secondary|Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)|The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with available data were included in this analysis.|||Seizures per 28 days||Full Range|Median
2624757|NCT01921270|Secondary|Mean Unified Dystonia Rating Scale (UDRS) Score as Measured by Un-blinded Rater|The UDRS measures dystonia severity. The UDRS is being rated by un-blinded video evaluators regarding severity of subject's dystonia. Scores range from 0 to 10; 0 indicating no dystonia, 5 indicating moderate dystonia, and 10 indicating the worst dystonia.|Baseline, Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
2624758|NCT01921270|Secondary|Mean Global Clinical Impression- Efficacy Index Score|The Clinical Global Impression - Efficacy Index is a 4×4 rating scale that assesses the therapeutic effect of treatment. Responses range on a scale from 0 to 4 with 4 being the best response.|Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
2624759|NCT01921270|Secondary|Mean Global Clinical Impression Scale (CGI-S) With Severity Index Score|"The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Responses are scored on a scale from 1 to 7; 1 represents normal, not at all ill and 7 represents among the most extremely ill patients."|Baseline, Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Error|Mean
2624760|NCT01921270|Secondary|Mean Global Clinical Impression - Improvement Scale (CGI) Index Score|"The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Responses are scored on a scale from 1 to 7; 1 represents very much improved and 7 represents very much worse."|Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
2624761|NCT01921270|Secondary|Mean Oromandibular Dystonia Quality of Life Questionnaire (OMDQ-25) Score|The OMDQ-25 is a subjective quality of life measurement made for patients with Oromandibular Dystonia. The maximum total score is 100 indicating the highest quality of life. A score of 50 indicates a mediocre quality of life. A lower score indicates perceived lower quality of life.|Baseline, Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
2624762|NCT01921270|Secondary|"Mean Fahn-Marsden Part B Speech Question (BFM-q21) Rating"|"The Fahn-Marsden Part B Speech Question assesses the ease of producing speech. Responses range from 0=Normal, 1=Slightly involved, easily understood, 2=Some difficulty understanding, 3=Marked difficulty understanding."|Baseline, Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
2624763|NCT01921270|Secondary|Mean Swallowing Disturbance Questionnaire (SDQ-20) Score|Ease of chewing and swallowing will be assessed by the SDQ-20 (modified to exclude question 5 due to redundancy as it relates to drooling and question 15 which is not relevant to the study as it involves prior aspiration pneumonias). Individual items are scored from 0 (never) to 3 (very frequently). The overall score is the total for all items; a higher score indicating more frequent swallowing disturbance; a lower score indicating no or less frequent disturbance, with a possible maximum score of 39.|Baseline, Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
2624764|NCT01921270|Secondary|Change in Number of Tongue Bites Per Day|The patient will be asked to estimate how many times they tend to accidentally/involuntarily bite their tongue per day.|Baseline, Week 12|Data were not collected.||||||
2624765|NCT01921270|Secondary|Mean Sialorrhea Clinical Scale for Parkinson's Disease (SCS-PD) Score|"The SCS-PD measures drooling. Individual items are scored on a scale from 0-3 where 0 represents never and 3 represents always. The overall maximum score is 21. A higher score indicates greater drooling severity. A lower score indicates lesser severity."|Baseline, Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
2624766|NCT01921270|Secondary|Change in Analogue Pain Scale Score|"Measure of jaw pain by visual analogue scale (0-100) where 0 represents no pain and 100 represents the most severe pain."|Baseline, Week 12|Data were not collected.||||||
2624789|NCT01921166|Primary|Oocytes|Number of oocytes retrieved|up to 24 months||||oocytes|oocytes||Number
2624790|NCT01921114|Other Pre-specified|Medical Resource Utilization Data Analysis|Economic outcomes with respect to medical resource utilization requirements will be compared between the two PICC groups. Only data from US sites will be used for this analysis.|Up to 30 days post-insertion|||||||
2624767|NCT01921270|Primary|Mean Global Dystonia Rating Scale Score as Measured by Blinded Rater|"This scale measures the severity of dystonia for the jaw and tongue by a blinded rater. Dystonia is rated from 0 to 10:~0=No dystonia present, 1=Minimal dystonia, 5=Moderate dystonia,10=Most severe dystonia"|Baseline, Week 6, Week 12|Participants who received low dose Dysport injections and completed all study visits. Two participants received two injections each for which data from the second were included in the analysis. For change from baseline to week 6, 18 subjects analyzed, for change from baseline to week 12, 17 subjects analyzed as one subject dropped out at 6 weeks.|||units on a scale||Standard Deviation|Mean
2624768|NCT01921257|Primary|Number of Subjects With AEs|To evaluate the safety and tolerability of Cat-PAD in paediatric subjects aged 5 to <12 years.|up to 36 weeks after start of treatment|All subjects enrolled|||participants|||Number
2624769|NCT01921205|Secondary|"Proportion of Subjects Who Achieved Seizure Free Status (Yes/no) for Subjects Who Completed the Maintenance Period"|The proportion of seizure free days is calculated as (days with number of seizures = 0) divided by (days with recorded data in the subject diary), where 'days with recorded data in the subject diary' excludes any days where 'Not Done' is recorded.|Week 7 to Week 16|Percentages are based on the number of subjects in the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects who completed the Maintenance Period have been included in this analysis.|||percentage of participants|||Number
2624770|NCT01921205|Secondary|Proportion of Seizure Free Days During the Maintenance Period for Subjects Who Completed the Maintenance Period|The proportion of seizure free days is calculated as (days with number of seizures = 0) divided by (days with recorded data in the subject diary), where 'days with recorded data in the subject diary' excludes any days where 'Not Done' is recorded.|Week 7 to Week 16|Percentages are based on the number of subjects in the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects who completed the Maintenance Period have been included in this analysis.|||days||Standard Deviation|Mean
2624771|NCT01921205|Secondary|Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Secondary Generalized Seizures|The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with Secondary Generalized Seizures were included in this analysis.|||Seizures per 28 days||Full Range|Median
2624772|NCT01921205|Secondary|Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Complex Partial Seizures|The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with Complex Partial Seizures were included in this analysis.|||Seizures per 28 days||Full Range|Median
2624773|NCT01921205|Secondary|Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Simple Partial Seizures|The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with Simple Partial Seizures were included in this analysis.|||Seizures per 28 days||Full Range|Median
2624774|NCT01921205|Secondary|Proportion of Subjects Experiencing an Increase in Partial Onset Seizure Frequency Per 28 Days of >=25 % From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)|Proportion of subjects is presented as percentage of participants. An increase is defined as a >=25% increase in POS frequency per 28 days from Baseline to the entire Treatment Period, otherwise <25% increase is defined as no increase.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with response data have been included in this analysis.|||percentage of participants|||Number
2624775|NCT01921205|Secondary|Proportion of Subjects Experiencing no Change in Partial Onset Seizure Frequency (Between <25 % Reduction and <25 % Increase) Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)|Proportion of subjects is presented as percentage of participants. No change is defined as between <25% reduction and <25% increase in POS frequency per 28 days from Baseline to the entire Treatment Period, otherwise not between <25% reduction and <25% increase is defined as a change.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with response data have been included in this analysis.|||percentage of participants|||Number
2624776|NCT01921205|Secondary|Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods)|Proportion of subjects is presented as percentage of participants. A >=25%-<50% response in the Treatment Period is defined as >=25% to <50% reduction in POS frequency per 28 days from Baseline to end of Treatment Period. A >=50%-<=75% response in the Treatment Period is defined as >=50% to <=75% reduction in POS frequency per 28 days from Baseline to end of Treatment Period. A 75% response in the Treatment Period is defined as >75% reduction in POS frequency per 28 days from Baseline to end of Treatment Period.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data.|||percentage of participants|||Number
2624778|NCT01921205|Secondary|Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the End of Maintenance Period|Proportion of subjects is presented as percentage of participants. A >=25%-<50% response in the Maintenance Period is defined as >=25% to <50% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period. A >=50%-<=75% response in the Maintenance Period is defined as >=50% to <=75% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period. A 75% response in the Maintenance Period is defined as >75% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data.|||percentage of participants|||Number
2624779|NCT01921205|Secondary|Proportion of Responders Where a Responder is Defined as a Participant With >= 50% Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period|Proportion of responders is presented as percentage of participants. A responder is a subject experiencing a 50 % or greater reduction in partial onset seizure frequency per 28 days from Baseline to the Maintenance Period.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with response data have been included in this analysis.|||percentage of participants|||Number
2624780|NCT01921205|Primary|Change in Partial Onset Seizure (POS) Frequency Per 28 Days From Baseline to the Maintenance Period|The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline.|Baseline to Week 16 (or last value on treatment)|The analysis was performed on the Full Analysis Set (FAS), which included all subjects who were randomized, received at least 1 dose of study medication, and had a Baseline and at least 1 post-Baseline assessment of seizure frequency data. Only subjects with available data were included in this analysis.|||Seizures per 28 days||Full Range|Median
2624781|NCT01921179|Secondary|Long Term Follow-up Change on Self Report Measures of Emotional Regulation 6+ Months Post GOALS Intervention|"Overall psychological distress is assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance Z Score (primary emotional regulation outcome measure)~(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)"|baseline, 6 months||||z score||Standard Deviation|Mean
2624782|NCT01921179|Secondary|Change on Self Report Measures of Emotional Regulation GOALS Post Intervention vs EDU Control Training|"Overall psychological distress will be assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance Z Score (primary emotional regulation outcome measure).~(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)"|baseline, 5 weeks|Out of 21 participants who completed GOALS training 3 participants did not complete one or more questions on POMS Out of 19 participants who completed EDU training 2 participants did not complete one or more questions on POMS|||z score||Standard Deviation|Mean
2624783|NCT01921179|Secondary|Long Term Follow-up After GOALS Training - Change in Performance on Complex Functional Task -Goal Processing Scale 6+ Months Post GOALS Intervention Relative to Baseline|Goal Processing Scale Overall Performance score (Primary functional performance outcome ) is calculated as the average of the 8 sub-domain scores including: Planning, Initiation, Maintenance of Attention, Self-Monitoring, Sequencing and Switching Attention, Flexible Problem Solving, Memory, and Execution. Minimum value is 0, maximum value is 10. Higher scores indicate better outcome|baseline, 6 months post GOALS training||||score on a scale||Standard Deviation|Mean
2624784|NCT01921179|Secondary|Change in Performance on Complex Functional Task -Goal Processing Scale Post GOALS Intervention vs EDU Control Training|Goal Processing Scale Overall Performance score (Primary functional performance outcome ) is calculated as the average of the 8 sub-domain scores including: Planning, Initiation, Maintenance of Attention, Self-Monitoring, Sequencing and Switching Attention, Flexible Problem Solving, Memory, and Execution. Minimum value is 0, maximum value is 10. Higher scores indicate better outcome.|baseline; 5 weeks|"Out of 21 participants who completed GOALS training 3 participants did not complete one or more sub-tests of GPS.~Out of 19 participants who completed EDU training 2 participants did not complete one or more sub-tests of GPS"|||score on a scale||Standard Deviation|Mean
2624785|NCT01921179|Primary|Long Term Follow-up After GOALS Training - Change in Performance on Neurocognitive Measures of Attention and Executive Function 6+ Months Post GOALS Intervention Relative to Baseline|"Attention and Executive Function Overall Domain Z Score (primary neuropsychological outcome measure) is calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching.~(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)"|baseline, 6+ months after GOALS training||||z score||Standard Deviation|Mean
2624786|NCT01921179|Primary|Change in Performance on Neurocognitive Measure of Attention and Executive Function Post GOALS Intervention vs EDU Control Training|"Attention and Executive Function Overall Domain Z Score (primary neuropsychological outcome measure) is calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching.~(The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)"|baseline, 5 weeks|Out of 21 participants who completed GOALS, 3 participants did not complete one or more neuropsychological tests|||z score||Standard Deviation|Mean
2624787|NCT01921166|Other Pre-specified|Number of Embryos From Vitrified Oocytes|per ovarian stimulation treatment protocol|up to 24 months|||||||
2624788|NCT01921166|Secondary|Number of Oocytes Vitrified||up to 24 months||||oocytes|||Number
2624791|NCT01921114|Secondary|Incidence of Other Catheter-related Complications|"Secondary objectives of this study are to investigate:~Incidence of other catheter-related complications, inclusive of catheter occlusion, catheter-related infection, technical failures, and premature catheter removals~Incidence of catheter occlusion (independently from other catheter-related complications)"|Up to 30 days post-insertion|The study was prematurely terminated and the PI was blinded to study data, and therefore never had access to the data and does not have any information that might help us locate it. Additionally, AngioDynamics' IT team ran a thorough search for any data related to this study and no results were found.||||||
2624792|NCT01921114|Primary|Incidence of Catheter-related Venous Thrombosis as Confirmed by Diagnostic Ultrasound||10 (+/-3) days and any time there is clinically suspected venous thrombosis (as per standard of care)|The study was prematurely terminated and the PI was blinded to study data, and therefore never had access to the data and does not have any information that might help us locate it. Additionally, AngioDynamics' IT team ran a thorough search for any data related to this study and no results were found.||||||
2624793|NCT01921101|Other Pre-specified|Immune Parameters|Markers of immune response (including IL-6, IL-10, adiponectin, leptin, CRP, TNF, CD4/CD8 and HLA/CD14|baseline and weekly while hospitalized|||||||
2624794|NCT01921101|Secondary|Death|The date of death for all participants that die between enrollment and their final data collection, 24 weeks following hospital discharge|date of occurence||||participants|||Number
2624795|NCT01921101|Secondary|Days on Mechanical Ventilation|the total number of days requiring mechanical ventilation while hospitalized|days|||||||
2624796|NCT01921101|Secondary|Length of Hospital Stay|The total number of days the patient is in the hospital|days in hospital|||||||
2624797|NCT01921101|Primary|Infection|All new infections that occurred (including blood, wound, sputum, urinary tract and pulmonary) from enrollment through hospital discharge recorded in the medical record were counted|Assessed daily from study enrollment through hospital discharge, an average of 3 weeks||||participants|||Number
2624798|NCT01920958|Secondary|Percentage of Participants With Post-Operative Complications and Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.|||percentage of participants|||Number
2624799|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Volume Reduced|Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on the drainage volume reduced in milliliters.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.|||percentage of participants|||Number
2624800|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Time Reduced|Pharmacoeconomic evaluation as assessed by the surgeon at hospital discharge based on drainage time reduced in days.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.|||percentage of participants|||Number
2624801|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit in Shortening of Time Spent in ICU|Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of time spent in ICU in days.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.|||percentage of participants|||Number
2624802|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit Based on Shortening of Hospital Stay|Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of hospital stay in days.|Up to 50 Days|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.|||percentage of participants|||Number
2624803|NCT01920958|Secondary|Percentage of Participants With Pharmacoeconomic Benefit Based on Savings of Operating Time|Pharmacoeconomic benefit was assessed by the surgeon based on savings/shortening of operating time in minutes.|Peri- and post-surgery (Up to 50 Days)|ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.|||percentage of participants|||Number
2624804|NCT01920958|Secondary|Length of Hospital and ICU Stay|Length of stay includes time (days) spent in the intensive care unit (ICU) and normal hospital station.|Up to 50 Days|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.|||days||Standard Deviation|Mean
2624805|NCT01920958|Secondary|Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume||Up to 50 Days|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.|||percentage of participants|||Number
2624806|NCT01920958|Secondary|Percentage of Participants With at Least One Drainage Inserted|The total number of participants where at least one drainage was used during the operation.|Baseline (Day of Surgery)|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.|||percentage of participants|||Number
2624908|NCT01920477|Primary|Duration of Remission on Minimal Steroid Therapy|Sum of all periods of absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of <=10 mg/day up to Week 60 was assessed.|Baseline up to approximately 60 weeks||||days||Standard Deviation|Mean
2624807|NCT01920958|Secondary|Assessment of TachoSil® by the Surgeon With Respect to Satisfaction Using a 10-Point Numerical Rating Scale|The surgeon evaluated Satisfaction in Operation of TachoSil® using a 10-point scale where: 1=very satisfied to 10=totally unsatisfied.|Peri- and post-surgery (Up to 50 Days)|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.|||score on a scale||Standard Deviation|Mean
2624808|NCT01920958|Secondary|Assessment of TachoSil® by the Surgeon With Respect to Utility in Operation Using a 10-Point Numerical Rating Scale|The surgeon evaluated Utility in Operation of TachoSil® using a 10-point scale where: 1=very useful to 10=completely useless.|Peri- and post-surgery (Up to 50 Days)|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.|||score on a scale||Standard Deviation|Mean
2624809|NCT01920958|Secondary|Assessment of TachoSil® by the Surgeon With Respect to Handling Using a 10-Point Numerical Rating Scale|The surgeon evaluated handling of TachoSil® using a 10-point scale where: 1=very good to 10=very poor.|Peri- and post-surgery (Up to 50 Days)|Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.|||score on a scale||Standard Deviation|Mean
2624810|NCT01920958|Primary|Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge||Up to 50 Days|Intent-to-treat population consisted of all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery.|||percentage of participants|||Number
2624811|NCT01920893|Post-Hoc|Change From Baseline in Nasal Total Symptoms Score (nTSS) at Week 16|nTSS was the sum of participant-assessed nasal symptom scores for nasal congestion/obstruction, decreased/loss of sense of smell, and rhinorrhea (anterior/posterior nasal discharge), each accessed on 0-3 categorical scale. Total score ranges from 0 (no symptoms) to 9 (severe symptoms). Higher score indicated severe symptoms.|Baseline, Week 16|Participants from ITT population with nTSS data available at Week 16.|||score on a scale||Standard Deviation|Mean
2624812|NCT01920893|Secondary|Change From Baseline in 22-Item Sinonasal Outcome Test (SNOT-22) at Week 16|The SNOT-22 was a validated questionnaire to assess the impact of chronic rhinosinusitis on quality of life. The total score may range from 0 (no problem)-110 (worst quality of life), higher scores represented worst quality of life; minimal clinically important change ≥ 8.90.|Baseline, Week 16|Participants from ITT population with SNOT-22 data available at Week 16.|||score on a scale||Standard Deviation|Mean
2624813|NCT01920893|Secondary|Time to First Response in NPS: Kaplan-Meier Estimate at Week 16|The time-to-first response in NPS: time from the date of randomization to the date of first NPS (defined as >=1 point reduction from baseline score); for participants without NPS >=1 point reduction, it was censored at the end of treatment date. The median time to first response was not estimated because the number of responses was too low in the Dupilumab arm. Therefore, alternative Kaplan-Meier statistics, the probability of response at Week 16, are presented as the descriptive measure statistics.|Baseline to Week 16|ITT population.|||Probability of response||95% Confidence Interval|Number
2624814|NCT01920893|Secondary|Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Percent Area Occupied by Disease|CT scan assessment included Lund-Mackay score and percentage of the area of maxillary sinuses occupied by disease.|Baseline, Week 16|Participants from ITT population with CT scan data available at Week 16.|||percent area||Standard Deviation|Mean
2624815|NCT01920893|Secondary|Change From Baseline in Sinus Computed Tomography (CT) Scan Assessments at Week 16: Lund-Mackay Score|CT scan assessment included Lund-Mackay score and percent of the maxillary sinuses occupied by disease. The Lund-Mackay scoring system rated each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses. The total score ranges from 0 (normal) - 24 (more opacified); higher score indicated worse status.|Baseline, Week 16|Participants from ITT population with CT scan data available at Week 16.|||score on scale||Standard Deviation|Mean
2624816|NCT01920893|Secondary|Change From Baseline in Smell Test (University of Pennsylvania Smell Identification Test [UPSIT]) Scores at Week 16|UPSIT was a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia)-40 (normal sense of smell), lower score indicated severe smell loss.|Baseline, Week 16|Participants from ITT population with data available for UPSIT at Week 16.|||score on scale||Standard Deviation|Mean
2624817|NCT01920893|Secondary|Change From Baseline in Nasal Peak Inspiratory Flow (NPIF) at Week 16|NPIF evaluation represents a physiologic measure of the air flow through both nasal cavities during forced inspiration and/or expiration expressed in liter per minute.|Baseline, Week 16|Participants from ITT population with data available for NPIF at Week 16.|||liter/minute||Standard Deviation|Mean
2624818|NCT01920893|Secondary|Change From Baseline in Visual Analogue Scale (VAS) for Rhinosinusitis Symptoms Severity at Week 16|Severity of rhinosinusitis symptoms were assessed on a 0 cm (not troublesome) - 10 cm (worst thinkable troublesome) VAS where higher score indicated worst thinkable troublesome.|Baseline, Week 16|Participants from ITT population with data available for Rhinosinusitis Symptoms Severity VAS at Week 16.|||centimetre (cm)||Standard Deviation|Mean
2624819|NCT01920893|Secondary|Change From Baseline in Participant Reported Symptoms Scores of Sinusitis at Week 16|Morning symptoms of sinusitis (nasal congestion/obstruction, anterior rhinorrhea [runny nose], posterior rhinorrhea [post nasal drip], and loss of sense of smell) were assessed using a 0 (no symptoms) - 3 (severe symptoms) categorical scale where higher score indicated severe symptoms.|Baseline, Week 16|Participants from ITT population with data available for symptom score at Week 16.|||score on a scale||Standard Deviation|Mean
2624820|NCT01920893|Secondary|Change From Baseline in Bilateral Endoscopic NPS at Week 16 in Participants With Asthma|NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 [no polyp] to 4 [large polyps] for each nostril), with a lower score indicating smaller-sized polyps.|Baseline, Week 16|Participants of the ITT population with asthma and with available data at Week 16.|||score on a scale||Standard Deviation|Mean
2625001|NCT01918761|Secondary|Overall Response Rate|Overall Response Rate (ORR) is defined as the proportion of patients with complete Response (CR) or partial Response (PR).|Until progression of disease (PD) or 24 month after end of treatment for participants with no PD. The study was suspended after 36 months||||percentage of participants||95% Confidence Interval|Number
2624821|NCT01920893|Primary|Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16|NPS was the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 [no polyp] to 4 [large polyps] for each nostril), with a lower score indicating smaller-sized polyps.|Baseline, Week 16|Intent-to-treat (ITT) population included all randomized participants analyzed according to the treatment group allocated by randomization. Here, number analyzed = number of participants with available data for specified time points.|||score on a scale||Standard Deviation|Mean
2624822|NCT01920854|Primary|Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6|The mean baseline transferrin will be calculated based on samples drawn just prior to infusion for all Cohorts (both SFP and placebo)|Baseline (1 day)|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||mg/dL||Standard Deviation|Mean
2624823|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz)|"Samples for volume of distribution in the terminal elimination phase (Vz) calculations were collected for all Cohorts (just those subjects that received SFP).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||dL||Standard Deviation|Mean
2624824|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2)|"Samples for terminal phase half life (t 1/2) calculations were collected for all Cohorts (just those subjects that received SFP).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||hours||Standard Deviation|Mean
2624825|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z)|"Samples for terminal phase rate constant (lambda z) calculations were collected for all Cohorts (just those subjects that received SFP).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||1/hour||Standard Deviation|Mean
2624826|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose)|"Samples for the dose-normalized maximal baseline corrected concentration of iron (Cmax/dose) calculations were collected for all Cohorts (just those subjects that received SFP).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL/mg||Standard Deviation|Mean
2624827|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax)|"Samples for observed time to reach maximum iron concentration (Tmax) calculations were collected for all Cohorts (both SFP and placebo).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||hours||Full Range|Median
2624828|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max)|"Samples maximal baseline corrected concentration of iron (Cmax) calculations were collected for all Cohorts (both SFP and placebo).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||microgram/dL||Standard Deviation|Mean
2624829|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance])|"Samples for Clearance (CL) calculations were collected for all Cohorts (just those subjects that received SFP).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||dL/hour||Standard Deviation|Mean
2624830|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf)|"Samples for area under the curve from time-zero extrapolated to infinity (AUC inf) calculations were collected for all Cohorts (just those subjects that received SFP).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||h*microgram/dL||Standard Deviation|Mean
2624831|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last)|"Samples for three area under the curve (AUC) calculations (AUC 0-12, AUC 0 - 4, and AUC last) were collected for all Cohorts (both SFP and placebo).~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||h*microgram/dL||Standard Deviation|Mean
2624832|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)|"Samples for unbound iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
2624833|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)|"Samples for unbound iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
2624834|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)|"Samples for non-transferrin bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
2624835|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)|"Samples for non-transferrin bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
2624836|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)|"Samples for total iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
2624837|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)|"Samples for total iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
2624838|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)|"Samples for transferrin saturation for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||percentage of saturation||Standard Deviation|Mean
2624839|NCT01920854|Secondary|Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)|"Samples for transferrin saturation for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||percentage of saturation||Standard Deviation|Mean
2624840|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)|"Samples for transferrin-bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
2624841|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)|"Samples for transferrin-bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
2624842|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)|"Serum iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
2624867|NCT01920594|Secondary|Change From Baseline to Peak in CSF Biomarker Erythropoietin Within 48 Hours Following DTA/TAAA Repair|CSF biomarker erythropoietin samples were collected for the analysis of ischemic neurologic injury. CSF samples were collected at Baseline and within 48 hours following DTA/TAAA repair to assess peak change from Baseline in CSF erythropoietin. Baseline was defined at Day 0. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 0) to 48 hours following DTA/TAAA repair|PD population. For the change from Baseline assessment, only those with both evaluable Baseline and post-dose values (so that the change could be calculated) were included in the analysis.|||International units per liter (IU/L)||Standard Deviation|Mean
2624843|NCT01920854|Primary|Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)|"Serum iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.~There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed."|48 hours|The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.|||micrograms/dL||Standard Deviation|Mean
2624844|NCT01920802|Other Pre-specified|Change in Lipid Metabolism|Change in lipid metabolism as measured by cholesterol/HDL ratio|Baseline to Day 28||||ratio||Standard Deviation|Mean
2624845|NCT01920802|Other Pre-specified|Change in Food Intake|Total grams of food consumed|Baseline to Day 28||||grams||Standard Deviation|Mean
2624846|NCT01920802|Other Pre-specified|Insulin Resistance|Homeostatic model assessment for Insulin Resistance (HOMA-IR) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin.|Baseline to Day 28||||HOMA-IR score||Standard Deviation|Mean
2624847|NCT01920802|Other Pre-specified|Change in Insulin|Change in Insulin levels from baseline to Day 28|Baseline to Day 28||||mlU/L||Standard Deviation|Mean
2624848|NCT01920802|Other Pre-specified|Change Glucose in People Taking Olanzapine or Iloperidone|To quantify, prospectively, change in glucose from baseline to Day 28|Baseline to study termination (about 12 weeks)||||mg/dL||Standard Deviation|Mean
2624849|NCT01920802|Secondary|Change in Leptin|Leptin levels measured at Day 3 compared to baseline|change in baseline to Day 3||||ng/dL||Standard Deviation|Mean
2624850|NCT01920802|Primary|Change in Adiposity|Total fat mass (excluding head) from baseline to Day 28|Baseline to Day 28||||grams||Standard Deviation|Mean
2624851|NCT01920802|Primary|Change in Body Weight|Delineate a pathophysiological mechanism of antipsychotic induced weight gain|baseline and 6 week visit||||kg||Standard Deviation|Mean
2624852|NCT01920594|Secondary|PK Parameters in CSF: Tmax of GSK1278863|CSF samples were collected immediately after the lumbar drain was placed, just prior to PNI, and 2, 24, 36 and 48 hours post PNI. In participants that developed spinal ischemia, the CSF drain was potentially maintained for longer than 48 hours. In that instance, daily CSF samples for PK were collected until the drain was removed. AUC (0-t) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Prior to potential neurological ischemia (PNI), 2, 24, 36 and 48 hours post PNI|PK Population. Only those participants available at the indicated time points were analyzed.|||Hours||95% Confidence Interval|Mean
2624853|NCT01920594|Secondary|PK Parameters in Blood: Time of Occurrence of Cmax (Tmax) of GSK1278863|Blood samples for PK analysis AUC(0-t) were collected at pre-dose (prior to the 100 mg dose), 1-3 hours after study drug was administered and then every 5 hours for 24 hours. On Days 1 and 3 samples were collected at pre-dose then 1, 3, 8 and 24 hours post dose. AUC (0-t) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Pre-dose, 1 to 3 hours post-dose, every 5 hours for 24 hours, 1, 3, 8 and 24 hours post-dose on Day 1 and 3|PK Population. Only those participants available at the indicated time points were analyzed.|||Hours||Full Range|Median
2624854|NCT01920594|Secondary|PK Parameters in CSF: Cmax of GSK1278863|CSF samples were collected immediately after the lumbar drain was placed, just prior to PNI, and 2, 24, 36 and 48 hours post PNI. In participants that developed spinal ischemia, the CSF drain was potentially maintained for longer than 48 hours. In that instance, daily CSF samples for PK were collected until the drain was removed. AUC (0-t) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Prior to potential neurological ischemia (PNI), 2, 24, 36 and 48 hours post PNI|PK Population. Only those participants available at the indicated time points were analyzed.|||Ng/L||Geometric Coefficient of Variation|Geometric Mean
2624855|NCT01920594|Secondary|PK Parameters in Blood: Maximum Observed Concentration (Cmax) of GSK1278863|Blood samples for PK analysis AUC(0-t) were collected at pre-dose (prior to the 100 mg dose), 1-3 hours after study drug was administered and then every 5 hours for 24 hours. On Days 1 and 3 samples were collected at pre-dose then 1, 3, 8 and 24 hours post dose. AUC (0-t) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Pre-dose, 1 to 3 hours post-dose, every 5 hours for 24 hours, 1, 3, 8 and 24 hours post-dose on Day 1 and 3|PK population. Only those participants available at the indicated time points were analyzed.|||Ng/mL||Geometric Coefficient of Variation|Geometric Mean
2624856|NCT01920594|Secondary|PK Parameters in CSF: AUC(0-t) of GSK1278863|CSF samples were collected immediately after the lumbar drain was placed, just prior to PNI, and 2, 24, 36 and 48 hours post PNI. In participants that developed spinal ischemia, the CSF drain was potentially maintained for longer than 48 hours. In that instance, daily CSF samples for PK were collected until the drain was removed. AUC (0-t) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Prior to potential neurological ischemia (PNI), 2, 24, 36 and 48 hours post PNI|PK Population. Only those participants available at the indicated time points were analyzed.|||Hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2624857|NCT01920594|Secondary|Pharmacokinetic (PK) Parameters in Blood: AUC(0-t) of GSK1278863|Blood samples for PK analysis AUC(0-t) were collected at pre-dose (prior to the 100 mg dose), 1-3 hours after study drug was administered and then every 5 hours for 24 hours. On Days 1 and 3 samples were collected at pre-dose then 1, 3, 8 and 24 hours post dose. AUC (0-t) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Pre-dose, 1 to 3 hours post-dose, every 5 hours for 24 hours, 1, 3, 8 and 24 hours post-dose on Day 1 and 3|PK Population. Only those participants available at the indicated time points were analyzed.|||Hour*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2624858|NCT01920594|Secondary|Number of Participants With Composite Index of All Cause Mortality and Disability (NIHSS>5/ASIA<40)|"The NIHSS was a systematic assessment tool that provided a quantitative measure of stroke-related neurologic deficit. Ratings for each item are scored with 0 as normal, and there was an allowance for untestable items. The NIHSS scores were categorized as: No event (NIHSS score=0), Mild (NIHSS score 1-4), Moderate (NIHSS score 5-15), or Severe (NIHSS score >15). The ASIA score was developed by the American Spinal Injury Association for the neurologic assessment of participants with a spinal injury. In this study, only the ASIA lower extremity motor score was assessed. This comprised five muscle groups scored from 0-5 on both the left and right lower extremities, for a maximal total score of 50. The ASIA scores were categorized as: mild (ASIA score 41-50), moderate (ASIA score 26-40), or severe (ASIA score <=25). Composite above includes participants with NIHSS>5 or ASIA<40 at the 30-day Follow-up or Death."|Up to Follow-up (Day 45)|PD Population.|||Participants|||Count of Participants
2624859|NCT01920594|Secondary|Assessment in AUC for Markers of Ischemic Organ Injury Including Tropinin Within 48 Hours|AUC from 8 hours post surgery (up to 48 hours post surgery) was derived for markers of ischemic organ injury troponin I and troponin T. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations.|Baseline (Day 0) and 8 to 48 hours following DTA/TAAA repair|PD population. Only those participants available at the indicated time points were analyzed.|||µg*hour/L||Geometric Coefficient of Variation|Geometric Mean
2624860|NCT01920594|Secondary|Number of Participants With Clinical Composite of All Cause Mortality, Stroke, Spinal Infarction, MI, Need for Dialysis/Sustained Doubling of Serum Creatinine|The clinical composite event rate included all-cause mortality (death), stroke, spinal infarction (paraplegia which was due to spinal infarct a result of the surgery, myocardial infarction, and the need for dialysis or sustained doubling of serum creatinine (acute kidney injury). The clinical composite endpoint used a first occurrence approach, i.e. a composite event was recorded at the time of first occurrence of any component of the composite.|Up to Follow-up (Day 45)|All Subjects Population.|||Participants|||Count of Participants
2624861|NCT01920594|Secondary|Number of Participants With Neurologic Outcomes Assessed by the American Spinal Injury Association (ASIA) Lower Extremity Motor Outcome Scale|The ASIA score was developed by the American Spinal Injury Association for the neurologic assessment of participants with a spinal injury. In this study, only the ASIA lower extremity motor score was assessed. This comprised five muscle groups scored from 0-5 on both the left and right lower extremities, for a maximal total score of 50. The ASIA scores were categorized as: mild (ASIA score 41-50), moderate (ASIA score 26-40), or severe (ASIA score <=25).|Surgical Day (Day 0), Post-operative Day 1, 2, 7 and follow-up (Day 45)|PD population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2624862|NCT01920594|Secondary|Number of Participants With Neurologic Outcomes Assessed by Modified Rankin Scale (mRS)|The mRS was a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The mRS was a 6 point disability scale with possible scores ranging from 0 up to 5. A separate category (of 6) was added for participants who died. The mRS scores were categorized as mild (mRS score 0-1), moderate (mRS score 2-3), or severe (mRS score >=4).|Post-operative Day 7 and follow-up (Day 45)|PD population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2624863|NCT01920594|Secondary|Number of Participants With Neurologic Outcomes Assessed by the National Institutes of Health Stroke Scale (NIHSS)|The NIHSS was a systematic assessment tool that provided a quantitative measure of stroke-related neurologic deficit. A trained observer rates the participant's ability to answer questions and perform activities. Ratings for each item are scored with 0 as normal, and there was an allowance for untestable items. The NIHSS scores were categorized as: No event (NIHSS score=0), Mild (NIHSS score 1-4), Moderate (NIHSS score 5-15), or Severe (NIHSS score >15). The single participant assessment required less than 10 minutes to complete. Data for participants with NIHSS administrated at surgical day, post-operative Day 1, Day 2, Day 7 and Follow-up Visit has been reported.|Surgical Day (Day 0), Post-operative Day 1, 2, 7 and follow-up (Day 45)|PD population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2624864|NCT01920594|Secondary|Change From Baseline to Peak in CSF Biomarker Neuron-specific Enolase (NSE) Within 48 Hours Following DTA/TAAA Repair|CSF biomarker NSE samples were collected for the analysis of ischemic neurologic injury. CSF samples were collected at Baseline and within 48 hours following DTA/TAAA repair to assess peak change from Baseline in CSF NSE. Baseline was defined at Day 0. Change from Baseline was calculated as post-Baseline minus Baseline value.|Baseline (Day 0) to 48 hours following DTA/TAAA repair|PD Population. For the change from Baseline assessment, only those with both evaluable Baseline and post-dose values (so that the change could be calculated) were included in the analysis.|||µg/L||Standard Deviation|Mean
2624865|NCT01920594|Secondary|Change From Baseline to Peak in CSF Biomarker Tau Protein Within 48 Hours Following DTA/TAAA Repair|CSF biomarker tau protein samples were collected for the analysis of ischemic neurologic injury. CSF samples were collected at Baseline and within 48 hours following DTA/TAAA repair to assess peak change from Baseline in CSF tau protein. Baseline was defined at Day 0. Change from Baseline was calculated as post-Baseline minus Baseline value.|Baseline (Day 0) to 48 hours following DTA/TAAA repair|PD Population. For the change from Baseline assessment, only those with both evaluable Baseline and post-dose values (so that the change could be calculated) were included in the analysis.|||ng/L||Standard Deviation|Mean
2624866|NCT01920594|Secondary|Change From Baseline to Peak in CSF Biomarker Lactate Dehydrogenase Within 48 Hours Following DTA/TAAA Repair|CSF biomarker lactate dehydrogenase samples were collected for the analysis of ischemic neurologic injury. CSF samples were collected at Baseline and within 48 hours following DTA/TAAA repair to assess peak change from Baseline in CSF lactate dehydrogenase. Baseline was defined at Day 0. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 0) to 48 hours following DTA/TAAA repair|PD Population. For the change from Baseline assessment, only those with both evaluable Baseline and post-dose values (so that the change could be calculated) were included in the analysis.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2625094|NCT01917513|Primary|Detection Rate of Adenomas and Serrated Lesions|The percentage of patients with at least one adenoma or serrated lesion in the G-EYE™ group will be compared to the Standard group|Approximalty following 14 days (histology results)||||Participants|||Count of Participants
2624868|NCT01920594|Secondary|Change From Baseline in AUC for CSF GFAP to 48 Hours|GFAP was a CSF biomarker that rise significantly in participants with neurologic injury following DTA/TAAA surgery. AUC for CSF GFAP from Baseline to 48 hours following DTA/TAAA repair was assessed to measure central nervous system injury. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Baseline was defined at Day 0. Change from Baseline was calculated as post-Baseline minus Baseline value.|Baseline(Day 0) to 48 hours following DTA/TAAA repair|PD Population.|||Hour*microgram per liter (hour*µg/L)||Geometric Coefficient of Variation|Geometric Mean
2624869|NCT01920594|Secondary|Change From Baseline in Area Under Curve (AUC) for CSF S100 Beta to 48 Hours|S100 beta was a CSF biomarker that rise significantly in participants with neurologic injury following DTA/TAAA surgery. AUC for CSF S100 beta from Baseline to 48 hours following DTA/TAAA repair was assessed to measure central nervous system injury. AUC was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Baseline was defined at Day 0. Change from Baseline was calculated as post-Baseline minus Baseline value.|Baseline(Day 0) to 48 hours following DTA/TAAA repair|PD Population.|||Hour*nanogram per liter (hour*ng/L)||Geometric Coefficient of Variation|Geometric Mean
2624870|NCT01920594|Secondary|Number of Participants With Hematology Parameters of PCI|Blood samples for assessment of hematology parameters platelet count, red blood cell count, white blood cell count, reticulocyte count, hemoglobin, hematocrit, mean corpuscle volume, mean corpuscle hemoglobin, mean corpuscle hemoglobin concentration, neutrophils, lymphocytes, monocytes, eosinophils and basophils was done at Randomization, Day 0 (done prior to 100 mg on-call dosing), 1, 2, 3, 4, 5, 6 and 7. Only those parameters for which at least one value of PCI was reported are summarized. Data for participants with hematology values outside the PCI range has been presented.|Up to post-operative Day 7|All Subjects Population.|||Participants|||Count of Participants
2624871|NCT01920594|Secondary|Number of Participants With Clinical Chemistry Parameters of PCI|Blood samples for assessment of clinical chemistry parameters aspartate amino transferase (AST), alanine amino transferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatase, blood urea nitrogen (BUN), creatinine, glucose, sodium, creatine phosphokinase, potassium, chloride, total carbon dioxide, calcium, total and direct bilirubin, uric acid, albumin and total protein was done at Randomization, Day 0 (done prior to 100 mg on-call dosing), 1, 2, 3, 4, 5, 6 and 7. Only those parameters for which at least one value of PCI was reported are summarized. Data for participants with clinical chemistry values outside the PCI range has been presented.|Up to post-operative Day 7|All Subjects Population.|||Participants|||Count of Participants
2624872|NCT01920594|Secondary|Number of Participants With Abnormal Electrocardiography (ECG) Parameters|Single 12-lead ECGs was obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and QT interval corrected for heart rate intervals. Data for participants with abnormal-clinical significant (CS) and abnormal-not clinically significant (NCS) ECG findings on post-operative Days 1, 2, 3, 4, 5, 6, 7 and during Follow-up Visits has been presented.|Up to Follow-up (Day 45)|All Subjects Population.|||Participants|||Count of Participants
2624873|NCT01920594|Secondary|Number of Participants With Vital Signs of Potential Clinical Importance (PCI)|Vital sign measurements included systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate. Criteria for vital sign values meeting PCI included: SBP < 70 millimeters of mercury (mmHg) and > 160 mmHg; DBP < 45 mmHg and > 110 mmHg. Data for participants with vital signs values outside the potential clinical importance range has been presented. Only those parameters for which at least one value of PCI was reported are summarized.|Up to Follow-up (Day 45)|All Subjects Population.|||Participants|||Count of Participants
2624874|NCT01920594|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, considered to be medically significant or is associated with liver injury and impaired liver function.|Up to Follow-up (Day 45)|All Subjects Population comprised of all participants who received at least one dose of study drug (GSK1278863 or placebo).|||Participants|||Count of Participants
2624875|NCT01920594|Primary|Change From Baseline to Peak in CSF Glial Fibrillary Acidic Protein (GFAP) Within 48 Hours Following DTA/TAAA Repair|GFAP is a CSF biomarker that rise significantly in participants with neurologic injury following DTA/TAAA surgery. CSF samples for the analysis of GFAP was collected at Baseline and within 48 hours following DTA/TAAA repair to assess peak change from Baseline in CSF GFAP. Baseline was defined at Day 0. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 0) to 48 hours following DTA/TAAA repair|PD population. For the change from Baseline assessment, only those with both evaluable Baseline and post-dose values (so that the change could be calculated) were included in the analysis.|||Microgram per liter (µg/L)||Standard Deviation|Mean
2624876|NCT01920594|Primary|Change From Baseline to Peak in Cerebrospinal Fluid (CSF) S100 Beta Within 48 Hours Following Descending Thoracic Aorta/Thoracoabdominal Aortic Aneurysm (DTA/TAAA) Repair|S100 beta is a CSF biomarker that rise significantly in participants with neurologic injury following DTA/TAAA surgery. CSF samples were collected at Baseline and within 48 hours following DTA/TAAA repair to assess peak change from Baseline in CSF S100 beta. Baseline was defined at Day 0. Change from Baseline was calculated as post-Baseline value minus Baseline value.|Baseline (Day 0) to 48 hours following DTA/TAAA repair|Pharmacodynamic (PD) population comprised of all participants from whom PD data was available. For the change from Baseline assessment, only those with both evaluable Baseline and post-dose values (so that the change could be calculated) were included in the analysis.|||Nanograms per liter (ng/L)||Standard Deviation|Mean
2624905|NCT01920477|Secondary|Percentage of Subjects Achieving Remission While Off Steroid Therapy by Week 60|Percentage of subjects with initial reduction of all steroids for >=8 weeks with an absence of new or nonhealing (established) lesions by Week 60 were to be assessed. All subjects remained on prednisone/prednisolone so this endpoint could not be analyzed.Time to remission off steroid therapy also could not be analyzed|Baseline up to approximately 60 weeks|All participants remained on steroid therapy||||||
2624877|NCT01920568|Secondary|Serum Concentration of Denosumab on Day 1, at Week 2, Week 5, Week 9, Week 13, Week 17, Week 19, Week 21, Week 25 and Week 49|Blood samples were drawn on study Day 1, pre-dose; 4 hours, 24 hours, and at Week 2 (168 hours); then pre-dose at Week 5, Week 9, Week 13, Week 17, Week 19 (no dose), Week 21, Week 25, and Week 49.|Samples were collected at pre-dose (Day 1); 4 hours, 24 hours, 168 hours post-dose; pre-dose at Week 5, Week 9, Week 13, Week 17; Week 19 (at 336 hours); pre-dose at Week 21, Week 25, Week 49|Pharmacokinetic (PK) Population: comprised of participants who signed informed consent to participate in the PK sub-study and who had their PK parameters evaluable according to GSK standards. Only those participants with evaluable parameters are included (represented by n=X in the category titles).|||micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2624878|NCT01920568|Secondary|Number of Participants With Confirmed Anti-denosumab Antibody Formation at Day 1, Week 25 and Week 53.|Anti-denosumab antibody formation was assessed at Day 1, Week 25 and Week 53. Binding antibody assay was used to assess number of participants with anti-denosumab antibody.|Day 1, Week 25 and Week 53|FAS-Safety Population. Only those participants on whom anti-denosumab antibody formation was analyzed at specified time point is presented (represented by n=X, X in the category titles).|||Participants|||Number
2624879|NCT01920568|Secondary|Number of Participants With Worst-case On-therapy Increase in the Indicated Hematology Parameters From Baseline Grade to the Indicated Grade.|Hematology parameters included hemoglobin, lymphocytes, platelet count, total neutrophils, white blood cell (WBC) count. All reported values are of participants with worst-case on-therapy increase to the specified grade: Any increase, that is, worst-case increase to grade 1, 2, 3, or 4 (any grade); worst-case increase to grade 3 (WC G3); and worst-case increase to grade 4 (WC G4). Participants with missing Baseline grade were assumed to have a Baseline grade of 0. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|Baseline and up to last study-related visit (up to 53 weeks)|FAS-Safety Population. Only participants whose indicated on-therapy lab values were available (represented by n=X, X in the category titles) were analyzed.|||Participants|||Number
2624880|NCT01920568|Secondary|Number of Participants With Worst-case (WC) On-therapy Increase in the Indicated Clinical Chemistry Parameters From Baseline Grade to the Indicated Grade.|Clinical chemistry parameters were measured at the Screening and Weeks 2, 5, 9, 13, 25, 37, and 53 visits. Clinical chemistry parameters measured on-study included albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, calcium (Ca), creatinine, magnesium, and phosphorous (P) inorganic. All reported values are of participants with worst-case on-therapy increase to the specified grade: Any increase, that is, worst-case increase to grade 1, 2, 3, or 4 (any grade); worst-case increase to grade 3 (WC G3); and worst-case increase to grade 4 (WC G4). The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) was used for grading. Participants with missing Baseline grade were assumed to have a Baseline grade of 0. The worst-case during the on-therapy period was determined taking into account both scheduled and unscheduled assessments.|Baseline and up to last study-related visit (up to 53 weeks)|FAS-Safety Population. Only participants whose indicated on-therapy laboratory values were available (represented by n=X, X in the category title) were analyzed.|||Participants|||Number
2624881|NCT01920568|Secondary|Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (Non-fatal Serious Adverse Events and Fatal Serious Adverse Events)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, non-fatal SAEs, fatal SAEs have been presented.|From start of IP through the Study Phase (49 weeks post-dose) (assessed up to 73 weeks)|Full-Analysis-Set Safety (FAS-Safety) Population: comprised of all randomized participants who received at least one dose of study treatment and was based on the actual study treatment received (if this differed from that to which the participant was randomized).|||Participants|||Number
2624882|NCT01920568|Secondary|Percent Change From Baseline in the Serum Bone-specific Alkaline Phosphatase (s-BALP) at Week 13.|Baseline value is the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline is the value at Indicated visit minus Baseline value. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100.|Baseline and Week 13|FAS-ITT Population. All participants who were randomized and had a observed values at Baseline and Week 13 were used in the analysis.|||Percent change||Full Range|Median
2624883|NCT01920568|Secondary|Percentage Change From Baseline to Week 13 in Urinary Amino-terminal Cross-linking Telopeptide of Type I Collagen of Type I Collagen Corrected for Urine Creatinine (uNTx/uCr) in Participants With Advanced Breast Cancer.|uNTx/uCr is the bone turnover marker correlated with the presence and extent of metastases, and the prognosis and response to bone targeted treatment. uNTx/uCr was expressed in nanomoles bone collagen equivalent per millimole (nM BCE/mM). Secondary objective: to compare the effect of denosumab with that of zoledronic acid on % chg from BL in uNTx/uCr at Wk 13 in breast cancer par. with bone metastases from solid tumors. Baseline value is the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline is the value at Week 13 minus Baseline value. Percent chg from BL is the chg from BL / BL value * 100. For missing Wk 13 observations, the last post-BL value was carried forward to obtain the Wk 13 value.|Baseline and Week 13|FAS-ITT Population. Participants with advanced breast cancer.|||Percent change||95% Confidence Interval|Least Squares Mean
2624906|NCT01920477|Secondary|Time to Remission While on Minimal Steroid Therapy by Week 60.|Time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to <=10 mg/day and maintained dose at <=10 mg/day with no new or nonhealing lesions for >=8 weeks by Week 60 was assessed|Baseline up to approximately 60 weeks||||days||95% Confidence Interval|Median
2624907|NCT01920477|Secondary|Percentage of Subjects Achieving Remission on Minimal Steroid Therapy at Week 60|Percentage of subjects who achieved absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of <=10 mg/day for > or = 8 weeks at Week 60 was assessed. Time to remission was not estimable.|Week 60||||percentage of participants|||Number
2624884|NCT01920568|Secondary|Percentage Change From Baseline to Week 13 in Urinary Amino-terminal Cross-linking Telopeptide of Type I Collagen of Type I Collagen Corrected for Urine Creatinine (uNTx/uCr) in Chinese Participants.|uNTx/uCr is the bone turnover marker correlated with the presence and extent of metastases, and the prognosis and response to bone targeted treatment. uNTx/uCr was expressed in nanomoles bone collagen equivalent per millimole (nM BCE/mM). Secondary objective: to compare the effect of denosumab with that of zoledronic acid on % chg from BL in uNTx/uCr at Wk 13 in par. of Chinese ancestry with bone metastases from solid tumors. Baseline value is the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline is the value at Week 13 minus Baseline value. Percent chg from BL is the chg from BL / BL value * 100. For missing Wk 13 observations, the last post-BL value was carried forward to obtain the Wk 13 value.|Baseline and Week 13|FAS-ITT Population. Chinese participants.|||Percent change||95% Confidence Interval|Least Squares Mean
2624885|NCT01920568|Primary|Percent Change (Chg) From Baseline (BL) to Week (Wk)13 in Urinary Amino-terminal Cross-linking Telopeptide of Type I Collagen Corrected for Urine Creatinine (uNTx/uCr)|uNTx/uCr is the bone turnover marker correlated with the presence and extent of metastases, and the prognosis and response to bone targeted treatment (trt). uNTx/uCr was expressed in nanomoles bone collagen equivalent per millimole (nM BCE/mM). Primary objective: to compare the effect of denosumab with that of zoledronic acid on % chg from BL in uNTx/uCr at Wk 13 in par. of Asian ancestry with bone metastases from solid tumors. BL value is the most recent, non-missing value prior to or on the 1st study trt dose date. Chg from BL is the value at Wk13 minus BL value. Percent chg from BL is the chg from BL / BL value * 100. For missing Wk 13 observations, the last post-BL value was carried forward to obtain the Wk 13 value.|Baseline (BL) and Week (Wk) 13|Full-Analysis-Set Intent-to-Treat (FAS-ITT) Population: comprised of all randomized participants regardless of whether or not study treatment was administered. Only those participants with values at Baseline and Week 13 were included in the analysis.|||Percent change||95% Confidence Interval|Least Squares Mean
2624886|NCT01920555|Secondary|Number of Participants With Abnormal and Clinically Significant CBC and Chemistry Labs by Treatment|"CBC~Chemistry (Total bilirubin, AST, ALT, GGT, ALK Phosphatase, Creatinine, BUN/Urea, Glucose, Uric Acid)~Testing was performed by study site laboratories and used institutional normal lab value ranges."|Day 3 and Early Termination Visit (approximately 3 weeks following intervention)||||Participants|||Count of Participants
2624887|NCT01920555|Secondary|Number of Participants Reporting Suicidal Ideation/Behavior on the Columbia Suicide Severity Rating Scale (C-SSRS)|The Columbia Suicide Severity Rating Scale (C-SSRS): The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior that was developed in the National Institute of Mental Health Treatment of Adolescent Suicide Attempters Study to assess severity and track suicidal events through any treatment. It is a clinical interview providing a summary of both ideation and behavior that can be administered during any evaluation or risk assessment to identify the level and type of suicidality present. The C-SSRS can also be used during treatment to monitor for clinical worsening or improvement. It contains 5 rating scale questions (yes/no) for suicidal ideation increasing severity and 5 rating scale questions (yes/no) for suicidal behavior of increasing severity. The time frame is for both lifetime and the past six months for the Baseline/Screening scale and since the last visit for the Since Last Visit scale.|Screening Visit and Days 0, 1, 3, 5, 7, 14 and 30 combined||||Participants|||Count of Participants
2624888|NCT01920555|Secondary|Clinician-Administered Dissociative States Scale (CADSS) Scores During Infusion|"The CADSS is a 23-item self-report scale for the assessment of dissociative states. It is a reliable, valid self-report instrument. The severity of each dissociative symptom ranges from 0 (not present) to 4 (extreme). The total score is calculated by summing across items, with a total possible range of 0-92. The CADSS was administered right before infusion, and 40, 80 minute and 120 minutes after the start of infusion. The timeframe is at this moment."|Day 0/baseline at 0, 40, 80, and 120 minutes||||units on a scale||Standard Deviation|Mean
2624889|NCT01920555|Secondary|Snaith-Hamilton Pleasure-Scale (SHAPS)|"The SHAPS is a 14-item self-report scale to measure hedonic tone. Items (e.g., I would enjoy reading a book, magazine, or newspaper.) are rated on a 4-point scale (1=strongly disagree, 2=disagree, 3=agree, 4=strongly agree). Either of the 'disagree' responses scores 1 point, and either of the 'agree' responses scores 0 points, for a total scale range of 0-14. Higher scores indicate greater inability to experience pleasure. Patients were asked to rate their experience of the past 24 hours."|A baseline assessment was made on Day 0, preceding infusion (i.e., treatment). Outcome assessments were made on days 1, 3, 5, 7, 14, and 30. The primary endpoint for this study was Day 3. Thus, the outcome measure table provides data on Days 0, 1 and 3|Several subjects dropped out of the study in between Day 0, Day 1 and Day 3.|||units on a scale||Standard Deviation|Mean
2624890|NCT01920555|Secondary|Clinical Positive Affect Scale (CPAS)|"The CPAS is a 16-item self-report scale to assess the level to which participants experience persistent distress due to feeling that they have not returned to their normal or premorbid state. Items (e.g., I look forward to things) are rated on a 5-point scale (0=not at all, 1=very much less than normal, 2=much less than normal, 3=slightly less than normal, 4=same as best or normal self). The possible scale range is 0 to 64, with higher scores indicating greater recovery from depression. Patients were asked to rate their experience of the past 24 hours."|A baseline assessment was made on Day 0, preceding infusion (i.e., treatment). Outcome assessments were made on days 1, 3, 5, 7, 14, and 30. The primary endpoint for this study was Day 3. Thus, the outcome measure table provides data on Days 0, 1 and 3|Several subjects dropped out of the study in between Day 0, Day 1 and Day 3.|||units on a scale||Standard Deviation|Mean
2624891|NCT01920555|Secondary|Symptoms of Depression Questionnaire (SDQ)|"The SDQ is a 44-item self-report scale, which aims to measure depression more comprehensively by including the assessment of symptoms in the anxiety-depression spectrum, including symptoms of irritability, anger attacks, and anxiety. Items are rated on an 6-point Likert scale, where participants are asked to rate if a specific symptom (e.g. How has your mood been over the past 24 hours?) is normal for him or her (score = 2), what is better than normal (score = 1), and what is worse than normal (scores = 3-6). The total scale score is calculated by averaging across the items, resulting in a possible range from 1 to 6. Higher scores indicate greater depression severity. When rating, patients were asked to consider their symptoms during the past 24 hours."|A baseline assessment was made on Day 0, preceding infusion (i.e., treatment). Outcome assessments were made on days 1, 3, 5, 7, 14, and 30. The primary endpoint for this study was Day 3. Thus, the outcome measure table provides data on Days 0, 1 and 3|Several subjects dropped out of the study in between Day 0, Day 1 and Day 3.|||units on a scale||Standard Deviation|Mean
2624892|NCT01920555|Secondary|Clinical Global Impressions-Improvement (CGI-I) Scale|"The CGI-I is a clinician rated single-item scale: Compared to the patient's condition at admission, how much has the patient changed?, rated on a 7-point response scale: 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, and 7 = Very much worse. In this case, admission referred to the CGI-S screening assessments performed between Day -28 an -7, one conducted during the screening visit, and a second rating conducted by a remote, independent rater."|A baseline assessment was made on Day 0, preceding infusion (i.e., treatment). Outcome assessments were made on days 1, 3, 5, 7, 14, and 30. The primary endpoint for this study was Day 3. Thus, the outcome measure table provides data on Days 0, 1 and 3|Several subjects dropped out of the study in between Day 0, Day 1 and Day 3.|||units on a scale||Standard Deviation|Mean
2624893|NCT01920555|Secondary|Clinical Global Impressions-Severity (CGI-S)|"The CGI-S is a clinician rated single-item scale: How depressed is the patient at this time?, rated on a 7-point response scale: 1 = Normal, not at all depressed, 2 = Borderline depressed, 3 = Mildly depressed, 4 = Moderately depressed. 5 = Markedly depressed, 6 = severely depressed, 7 = Among the most severely depressed patients. When rating patients, clinicians were asked to consider the past 24 hours."|A baseline assessment was made on Day 0, preceding infusion (i.e., treatment). Outcome assessments were made on days 1, 3, 5, 7, 14, and 30. The primary endpoint for this study was Day 3. Thus, the outcome measure table provides data on Days 0, 1 and 3|Several subjects dropped out of the study in between Day 0, Day 1 and Day 3.|||units on a scale||Standard Deviation|Mean
2624894|NCT01920555|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)|"The MADRS is a 10-item clinician-rated scale measuring depression severity. Symptoms are rated on a 7-point scale, where 0 = not present, and 1-6 represent increasing severity. Values 2, 4, and 6 have specific anchoring text (e.g., 2=Difficulties in starting activities. 4=Difficulties in starting simple routine activities which are carried out with effort, 6=Complete lassitude. Unable to do anything without help.) Values 1, 3, and 5 do not have specific text. The possible scale range is 0-60, where higher values represent higher severity. In this study, the MADRS was used to rate symptoms occurring in the past 3 days."|A baseline assessment was made on Day 0, preceding infusion (i.e., treatment). Outcome assessments were made on days 3, 5, 7, 14, and 30. The primary endpoint for this study was Day 3. Thus, the outcome measure table provides data on Days 0 and 3.|Several subjects dropped out of the study in between Day 0, Day 1 and Day 3.|||units on a scale||Standard Deviation|Mean
2624895|NCT01920555|Primary|Hamilton Rating Scale for Depression - 6 Items|The HAMD6 is a 6-item clinician-rated scale, where clinicians rate the presence of depression symptoms (i.e., depressed mood, guilt, work and interests, psychomotor retardation, psychic anxiety, somatic symptoms) on a 5-point scale, where 0 = not present, and 1-4 represent increasingly severe symptoms. One item (i.e., somatic symptoms) is rated on only a 3-point scale, ranging from 0-2. The possible scale range is 0-22, where higher values represent more severe depression. This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. In this study, the HAMD6 was used to assess symptoms occurring in the past 24 hours.|A baseline assessment was made on Day 0, preceding infusion (i.e., treatment). Outcome assessments were made on days 1, 3, 5, 7, 14, and 30. The primary endpoint for this study was Day 3. Thus, the outcome measure table provides data on Days 0, 1, & 3|Several subjects dropped out of the study in between Day 0, Day 1 and Day 3.|||units on a scale||Standard Deviation|Mean
2624896|NCT01920477|Secondary|Change From Baseline for CD19+ B Cell Count|CD19+ B cell count will be performed using Flow Cytometry|Baseline up to approximately 60 weeks|number of participants varied across visits|||10^9 cells/L||Standard Deviation|Mean
2624897|NCT01920477|Secondary|Largest Mean Decrease From Baseline for Immunoglobulin A, G and M|Immunoglobulins A, G and M were assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response|Baseline up to approximately 60 weeks|number of participants varied across visits|||g/L||Standard Deviation|Mean
2624898|NCT01920477|Secondary|Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin M|Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response|Baseline up to approximately 60 weeks|number of participants varied across visits|||Participants|||Count of Participants
2624899|NCT01920477|Secondary|Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin G|Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response|Baseline up to approximately 60 weeks|number of participants varied across visits|||Participants|||Count of Participants
2624900|NCT01920477|Secondary|Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin A|Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response|Baseline up to approximately 60 weeks|number of participants varied across visits|||Participants|||Count of Participants
2624901|NCT01920477|Secondary|Plasma Trough Concentrations of Ofatumumab|Only plasma (trough) concentrations of ofatumumab were presented|4 hours post baseline, Days 1-4,7,14, Weeks 4,8,12,16,20,24,36,48,52,56, up to approximately 60 weeks|number of participants varied across visits|||ng/mL||Standard Deviation|Mean
2624902|NCT01920477|Secondary|Percentage of Participants With no Flare/Relapse by Week 60|Percentage of participants achieving absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of <=10 mg/day and did not subsequently have a appearance of >=3 new lesions within 1 month that did not heal spontaneously within 1 week, or to the time when there was an extension of lesions that were present at the randomization by Week 60 was assessed|Baseline up to approximately 60 weeks|number of participants varied across visits|||percentage of participants|||Number
2624903|NCT01920477|Secondary|Time to Initial Flare/Relapse by Week 60|Time from randomization to the time of appearance of >=3 new lesions within 1 month that did not heal spontaneously within 1 week, or to the time when there was an extension of lesions that were present at the randomization by Week 60 was assessed|Baseline up to approximately 60 weeks||||days||95% Confidence Interval|Median
2624904|NCT01920477|Secondary|Number of Days a Subject Maintained Minimal Steroid Therapy by Week 60.|Number of days a subject maintained minimal steroid therapy (an oral prednisone/prednisolone dose of ≤10 mg/day in the absence of new or nonhealing lesions) by Week 60.|Baseline up to approximately 60 weeks||||days||Standard Deviation|Mean
2625095|NCT01917344|Secondary|Tremor as Determined Through Neurological Evaluation||During period of evaluation, approximately 8 hours|||||||
2624909|NCT01920477|Primary|Number of Subjects Who Experienced Sustained Remission on Minimal Steroid Therapy|Sustained remission = time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to <=10 mg/day and maintenance of a dose <=10 mg/day with no new or nonhealing lesions for >=8 weeks and maintenance of the status until Week 60.|Baseline up to approximately 60 weeks||||participants|||Number
2624910|NCT01920282|Other Pre-specified|Oxidized LDL Concentration||12 weeks|||||||
2624911|NCT01920282|Secondary|Insulin Sensitivity (HOMA-IR)|The HOMA index was calculated as the product of plasma blood glucose and insulin divided by 22.5.|12 weeks||||Arbitrary units||Standard Error|Mean
2624912|NCT01920282|Primary|Beta-stiffness Index|Longitudinal B-mode images of the left common carotid artery diameter (1-2 cm proximal to the carotid bulb) were obtained over 15 consecutive cardiac cycles. Brachial blood pressure was measured via an automated sphygmomanometer. Quantification of systolic and diastolic carotid artery diameters were analyzed with the Vascular Research Tools 5 software program. Beta-stiffness index was calculated as: Beta = ln(P1/P0)/((D1-D0)/D0), where D0 represents the minimal diameter recorded during diastole, D1 represents the maximal diameter recorded during systole, P0 represents the pressure measured during diastole, and P1 represents the pressure measured during systole.|12 weeks||||Arbitrary units||Standard Error|Mean
2624913|NCT01920178|Other Pre-specified|Number of Participants With Adverse Events During and Following Each Study Treatment||12 months||||participants|||Number
2624914|NCT01920178|Secondary|Measure Clinical Improvement as Judged by the Patient and Determine Presence of Onychomycosis by PCR Analysis of Nail Samples||12 months|PCR lab analysis of nail samples obtained for each subject was not performed with the original study sponsor Nuvolase, Inc/ PinPointe withdrawing support for such analysis during the study.||||||
2624915|NCT01920178|Primary|Measure Improvement in Target Toenails During the Study Period by Deeming a Clinical Success if Patient Experiences at Least a 50% Reduction in the Area of Involved Nail, Judged by the Clinician, and Judged by an Independent Evaluator.||12 months|Original grooved markings scored into the Target nails (hallux nails) on initial laser treatment visit to indicate most proximal aspect of fungal infection was intended to track the growth of the nail and to evaluate for improvement. Grooved markings did not survive after initial visit making it impossible to obtain valid primary endpoint data.||||||
2624916|NCT01919996|Secondary|Occurrence of a Clinically Significant Change (Improvement or Worsening) Based on Five Ophthalmic Examinations|Clinically significant change (improvement or worsening) is based on five ophthalmic exams at baseline and the final visit. Any 1 or more of these conditions are a clinically significant change: 1) A worsening in BCVA (distance), as defined in outcome measure 1 OR an improvement in BCVA (distance) as defined in outcome measure 2. 2) A worsening in color vision (FM-100), as defined in outcome measure 1 OR an improvement in color vision (FM-100) as defined in outcome measure 2. 3) A worsening in Amsler Grid, as defined in outcome measure 1, OR an improvement in Amsler Grid, as defined in outcome measure 2. 4) A worsening in anterior segment biomicroscopy, as defined in outcome measure 1 OR an improvement in anterior segment biomicroscopy as defined in outcome measure 2. 5) A worsening in dilated indirect ophthalmoscopy, as defined in outcome measure 1 OR an improvement in dilated indirect ophthalmoscopy as defined in outcome measure 2.|14 days|The safety population included all enrolled participants that took at least one dose of study medication. One participant was not evaluable because visual acuity was not corrected at Baseline (Day 1) and was corrected at Final Visit (Day 14).|||percentage of participants|||Number
2624917|NCT01919996|Secondary|Occurrence of a Clinically Significant Improvement Based on Five Ophthalmic Examinations|1 or more of these conditions are clinically significant improvement based on five ophthalmic exams:1) clinically significant improvement in BCVA(distance) at the final visit, in either eye, defined as an increase in score of 5 or more letters from baseline in ETDRS BCVA.2) Assessment of abnormal clinically significant at baseline and normal or abnormal, non-clinically significant at final visit in color vision(FM-100) in either eye. 3) Assessment of abnormal clinically significant at baseline and normal/abnormal, non-clinically significant at final visit in Amsler Grid in either eye. 4) Assessments of abnormal clinically significant at baseline and normal/abnormal, non-clinically significant at final visit in anterior segment biomicroscopy, in any of the 10 eye structures in either eye. 5)Assessments of abnormal clinically significant at baseline and normal/abnormal, nonclinically significant at final visit in dilated ophthalmoscopy in any of the 5 eye structures in either eye.|14 days|The safety population included all enrolled participants that took at least one dose of study medication. One participant was not evaluable because visual acuity was not corrected at Baseline (Day 1) and was corrected at Final Visit (Day 14).|||percentage of participants|||Number
2624918|NCT01919996|Primary|Occurrence of a Clinically Significant Worsening Based on Five Ophthalmic Examinations|Clinically significant worsening is an observed worsening in any of the five ophthalmic exams: 1) Clinically significant worsening in best corrected visual activity (BCVA) (distance) at the final visit, in either eye, is defined as a decrease in score of 5 or more letters from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA. 2) An assessment of abnormal clinically significant at final visit in color vision Farnsworth Munsell 100 Hue Test (FM-100) in either eye. 3) An assessment of abnormal clinically significant at final visit in Amsler Grid in either eye. 4) Assessments of abnormal clinically significant at final visit in anterior segment biomicroscopy, in any of the 10 eye structures in either eye. 5) Assessments of abnormal clinically significant at final visit in dilated indirect ophthalmoscopy in any of the 5 eye structures in either eye.|14 days|The safety population included all enrolled participants that took at least one dose of study medication. One participant was not evaluable because visual acuity was not corrected at Baseline (Day 1) and was corrected at Final Visit (Day 14).|||percentage of participants|||Number
2624919|NCT01919970|Secondary|Clinical Global Impression - Severity Scale|"This scale measures the severity of anxiety symptoms in children. The total scale range is 0-6 where 0 is the minimum and 6 the maximum. Higher scores correspond to more severe anxiety symptom severity. The scale consists of only 1 item that a clinician rates based on their judgement of anxiety severity.~The outcome measure is reporting a change score in which the score at baseline is compared to the score at 12 weeks (post-treatment). This is analyzed as a function of groups/condition (cognitive behavioral therapy versus Treatment as Usual)."|After an average of 12 weeks (Post-treatment)||||units on a scale||Standard Deviation|Mean
2625096|NCT01917344|Secondary|Diffusion Tensor Imaging (DTI) Findings Through MRI||During period of evaluation, approximately 8 hours|||||||
2624920|NCT01919970|Primary|Pediatric Anxiety Rating Scale|"This scale measures the severity of anxiety symptoms in children. The total scale range is 0-30 where 0 is the minimum and 30 the maximum. Higher scores correspond to more severe anxiety symptom severity. The total scale was used which corresponds to summing the 6 severity items.~The outcome measure is reporting a change score in which the score at baseline is compared to the score at 12 weeks (post-treatment). This is analyzed as a function of groups/condition (cognitive behavioral therapy versus Treatment as Usual)."|After an average of 12 weeks (post-treatment)||||units on a scale||Standard Deviation|Mean
2624921|NCT01919814|Secondary|Evaluation of Satiety by Means of Visual Analogue Scale|The Visual Analogue scale allows you to mark a vertical line across the horizontal scale on how hungry you are or not. The Visual Analogue scale was used to evaluate hunger, fullness, longing for food, prospective intake, satisfaction, desire for salty food, desire for savory food, thirst, and desire for sweet food. The scale ranged from 0 to 100mm; the higher values indicated greater outcomes.|30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo||||units on a scale||Standard Deviation|Mean
2624922|NCT01919814|Secondary|Evaluation of Appetite|The Visual Analogue scale allows you to mark a vertical line across the horizontal scale on how hungry you are or not. The Visual Analogue scale was used to evaluate hunger, fullness, longing for food, prospective intake, satisfaction, desire for salty food, desire for savory food, thirst, and desire for sweet food. The scale ranged from 0 to 100mm; the higher values indicated greater outcomes.|30 minutes, 60 minutes, 120 minutes after consuming the drug or placebo||||units on a scale||Standard Deviation|Mean
2624923|NCT01919814|Primary|Difference in Pizza Consumed During Two Meals|Four hours after breakfast administration of Appethyl™ or placebo(inactive liquid) is given. You will be presented with a standard lunch and then (5 hours after lunch) pizza in a quantity of more than you could reasonably be expected to eat 5 hours after the start of your lunch meal and be asked to eat to your satisfaction over 30 minutes. You are not expected to eat all of the pizza.|5 hours after lunch (9 hours after administration of Appethyl from the morning)|One participant dropped because of adverse event|||calories||Standard Deviation|Mean
2624924|NCT01919801|Other Pre-specified|Area Under the Plasma Concentration Versus Time Curve (AUC) of Icatibant and Its Metabolites (M1 and M2)|Area under the plasma concentration-time curve of Icatibant and its metabolites (M1 and M2) were analyzed. A population pharmacokinetic analysis approach using sparse pharmacokinetic sampling obtained from a subset of subjects was used to evaluate exposure to icatibant.|0.75 and 2 hours post-dose|PK analysis population.|||hours*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
2624925|NCT01919801|Secondary|Percentage of Participants With Time to Meeting Discharge Criteria (TMDC) at Specified Time Points|TMDC was based on the investigator-assessed angioedema-associated upper airway symptom assessments. It was calculated from the time of study drug administration to the earliest time point at which the symptoms of difficulty breathing and difficulty swallowing were absent and the symptoms of voice change and tongue swelling were mild or absent and all subsequent assessments continued to satisfy these conditions. These symptoms were evaluated by the investigator using a 5-point grading scale (0=absent, 1=mild, 2=moderate, 3=severe, and 4=very severe). TMDC was analysed using Kaplan-Meier estimates.|4, 6, and 8 hours post treatment|mITT population.|||percentage of participants|||Number
2624926|NCT01919801|Secondary|Number of Participants Experienced ACE-I-induced Angioedema Attack Following Study Drug Administration|Number of participants with the use of conventional medications (corticosteroids, antihistamines, epinephrine) for the treatment of symptoms of the ACE-I- induced angioedema attack following study drug administration were presented.|Day 0 up to Day 5|mITT population.|||participants|||Number
2624927|NCT01919801|Secondary|Number of Participants Admitted to Hospital or Intensive Care Unit (ICU)|Number of participants with and without an occurrence of admission to the hospital (inpatient) or ICU post-treatment due to the ACE-I-induced angioedema attack were described.|Day 0 up to Day 5|mITT population.|||participants|||Number
2624928|NCT01919801|Secondary|Number of Participants Experienced Airway Intervention Due to ACE-I-induced Angioedema|Airway Intervention included intubation, tracheotomy, cricothyrotomy.|Day 0 up to Day 5|Modified Intent to treat (mITT) population included all randomized participants who received the study drug.|||participants|||Number
2624929|NCT01919801|Secondary|Time to Onset of Symptom Relief (TOSR)|TOSR was calculated for the individual symptoms with pre-treatment scores of 2 (moderate) or more improved by at least 1 severity grade and the individual symptoms with pretreatment scores of 0 or 1 (absent or mild) were scored again at 0 or 1 and all the subsequent assessments continued to satisfy this condition. Time-to-event data were summarized using Kaplan-Meier estimates.|Day 0 up to Day 5|ITT population.|||days||Inter-Quartile Range|Median
2624930|NCT01919801|Primary|Number of Participants With Clinically Significant Changes in Laboratory Evaluation, Vital Signs, Electrocardiogram (ECG) and Physical Examination|During laboratory evaluation, serum chemistry and hematology blood tests, and urinalysis were performed. Vital signs parameters included evaluation of pulse rate and systolic and diastolic blood pressure. Standard 12-lead ECGs were performed and ECG recordings were read locally at the study site by a cardiologist. Physical examination was performed with examination of major body systems per routine clinical practice.|Day 0 to Day 5|Safety population.|||participants|||Number
2624931|NCT01919801|Primary|Number of Participants With Treatment Emergent Injection Site Reaction|Injection site reaction included erythema, swelling, cutaneous pain, burning sensation, itching and warm sensation|Day 0 to Day 5|Safety population.|||participants|||Number
2624932|NCT01919801|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.|From start of study drug administration (Day 0) up to follow-up (Day 5)|Safety population included all participants who received the study drug.|||participants|||Number
2625097|NCT01917344|Secondary|Volumetric MRI Findings||During period of evaluation, approximately 8 hours|||||||
2625098|NCT01917344|Secondary|Electroencephalogram (EEG) Findings||During period of evaluation, approximately 8 hours|||||||
2624933|NCT01919801|Primary|Time to Meeting Discharge Criteria (TMDC)|TMDC was based on the investigator-assessed angioedema-associated upper airway symptom assessments. It was calculated from the time of study drug administration to the earliest time point at which the symptoms of difficulty breathing and difficulty swallowing were absent and the symptoms of voice change and tongue swelling were mild or absent and all subsequent assessments continued to satisfy these conditions. These symptoms were evaluated by the investigator using a 5-point grading scale (0=absent, 1=mild, 2=moderate, 3=severe, and 4=very severe). TMDC was analysed using Kaplan-Meier estimates.|Day 0 up to Day 5|Intent-to-treat (ITT) population included all randomized participants.|||days||Inter-Quartile Range|Median
2624934|NCT01919723|Secondary|Periprocedural Myocardial Infarction (PMI)|Number of subjects that developed PMI. Periprocedural myocardial infarction (PMI) was defined as an increase in troponin I values >5 x 99th percentile the upper limit of normal in patients with normal baseline value on admission, or a rise of troponin I values >20% after PCI if the baseline value was elevated.|Up to 24 hours|2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.|||Number of subjects|||Number
2624935|NCT01919723|Secondary|Bleeding Complications|Number of subjects that developed gastrointestinal bleeding after Percutaneous Coronary Intervention (PCI). These subjects were categorized under Bleeding Academic Research Consortium 3b. Type 3b bleeding includes overt bleeding plus a hemoglobin drop of ≥5 g/dL (provided the hemoglobin drop is related to bleeding), cardiac tamponade, bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), and bleeding requiring intravenous vasoactive drugs.|up to 24 hours|2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.|||Number of subjects|||Number
2624936|NCT01919723|Secondary|High On-treatment Platelet Reactivity (HPR)|Percentage of participants with HPR. HPR is defined as platelet aggregation >59% in response to 20 µM ADP.|Comparing baseline and follow-up (2 hours)|2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.|||percentage of participants|||Number
2624937|NCT01919723|Primary|Change in Percent Inhibition of Platelet Aggregation (%IPA)|Change from baseline in %IPA at 2 hours after stimulation with 20µM ADP (µM-micromolar, ADP-Adenosine diphosphate), measured in blood by an aggregometer among patients randomized to ticagrelor and 2 boluses of eptifibatide vs. ticagrelor and 2 boluses plus infusion of eptifibatide.|Baseline and 2 hours|2 subjects in each arm did not meet the inclusion criteria (blood hemolyzed) and thus we do not have the primary and secondary outcomes for them.|||percentage of IPA||Standard Deviation|Mean
2624938|NCT01919697|Secondary|Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment|Treatment continuation was measured using 5-point score: 1=Not At All Likely, 2=A Little Likely, 3=Moderately Likely, 4=Quite Likely, 5=Very Likely|From first dose up to 72 weeks|This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study.|||score on a scale|Readings|Standard Deviation|Mean
2624939|NCT01919697|Secondary|Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364|Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. Treatment Satisfaction was measured using a 5-point score: 1=Not At All Satisfied, 2=A Little Satisfied, 3=Moderately Satisfied, 4=Quite Satisfied, 5=Very Satisfied.|From first dose up to 72 weeks|This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study.|||score on a scale|Readings|Standard Deviation|Mean
2624940|NCT01919697|Secondary|Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364|Change of Constipation measured using a 7-point score: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse Baseline is defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study.|From first dose up to 72 weeks|All enrolled patients who had at least one dose of the study drug and had at least one post-baseline Patient Global Assessment (PGA) were included in this population. A total of 2378 patients including the re-enrolled patients who previously participated and completed this open-label study was used for assessments.|||score on a scale|Readings|Standard Deviation|Mean
2624941|NCT01919697|Secondary|Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364|Constipation severity was measured using a 5-point score: 1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study.|Form first dose up to 72 weeks|This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study.|||score on a scale|Readings|Standard Deviation|Mean
2624942|NCT01919697|Primary|Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline|Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. The Common Terminology Criteria for Adverse Events (CTCAE), Grades 1 through 5 were used for descriptions of severity for each Adverse Event (AE): Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental Activities of Daily Living (ADL); Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 - Life-threatening consequences; urgent intervention indicated; Grade 5 - Death related to AE.|From first dose up to 72 weeks|This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study.|||participants|Readings||Number
2624943|NCT01919697|Primary|Summary of ECG Results Shift From Baseline at > Day 364|Baseline was defined as the last non-missing value collected prior to first dose of study drug)|From first dose up to 72 weeks|This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study.|||participants|Readings||Number
2625099|NCT01917344|Secondary|Full Scale Intelligence Quotient (IQ)||During period of evaluation, approximately 8 hours|||||||
2624944|NCT01919697|Primary|Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute)|The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).|From first dose up to 72 weeks|This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study.|||breaths per minute|Readings|Standard Deviation|Mean
2624945|NCT01919697|Primary|Summary of Vital Signs at >Day 364 - Body Temperature (°C)|The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).|From first dose up to 72 weeks|This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study.|||°C|Readings|Standard Deviation|Mean
2624946|NCT01919697|Primary|Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute)|The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).|From first dose up to 72 weeks|This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study.|||beats per minute|Readings|Standard Deviation|Mean
2624947|NCT01919697|Primary|Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg)|The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).|From first dose up to 72 weeks|This population (2378 patients) consisted of the Safety Population and the re-enrolled patients who previously participated and completed this open-label study.|||mmHg|Readings|Standard Deviation|Mean
2624948|NCT01919697|Primary|Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide|Tolerability was evaluated based on number of patients who experienced at least one TEAE leading to discontinuation of the study drug|From first dose up to 72 weeks|The Safety Population consisted of all enrolled patients who had at least one dose of the study drug.|||Participants|||Count of Participants
2624949|NCT01919697|Primary|Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)|All clinically significant findings upon Physical Examinations of the Safety Population during the treatment period were reported as TEAEs. Safety was evaluated based on number of patients who experienced at least one TEAE.|From first dose up to 72 weeks|The Safety Population consisted of all enrolled patients who had received at least one dose of the study drug.|||Participants|||Count of Participants
2624950|NCT01919606|Secondary|Incidence of Adverse Events||10 days post surgery plus or minus 3 days||||number of events|||Number
2624951|NCT01919606|Primary|Duration of Analgesia||End of surgery to time of subject's first postsurgical opioid administration (through 72 hours)|||||||
2624952|NCT01919450|Primary|Measure Quantitated Myocardial Perfusion Reserve After a 1 Minute Delay in Lexiscan (Regadenoson)|The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.|1 minute||||Ratio||Standard Deviation|Mean
2624953|NCT01919450|Primary|Measure Quantitated Myocardial Perfusion Reserve After a 10 Second Delay in Lexiscan (Regadenoson)|The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.|10 seconds||||Ratio||Standard Deviation|Median
2624954|NCT01919450|Primary|Measure Quantitated Myocardial Perfusion Reserve After a 2 Minute Delay in Lexiscan (Regadenoson)|The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.|2 mintues||||Ratio||Standard Deviation|Mean
2624955|NCT01919450|Primary|Measure Quantitated Myocardial Perfusion Reserve After a 4 Minute Delay in Lexiscan (Regadenoson)|The end-point of this study is to establish the mean and standard deviations of myocardial blood flow reserve (peak stress to rest ratio) values based on a 10 second, 1 minute, 2 minute and 4 minute delays between Lexiscan (Regadenoson) injection and the start of myocardial perfusion PET imaging.|4 minutes||||Ratio||Standard Deviation|Mean
2624956|NCT01919411|Other Pre-specified|Number of Participants With Post Operative Infection|The investigators will record the rate of post operative infections in the two groups.|Six weeks postoperatively||||Participants|||Count of Participants
2624957|NCT01919411|Other Pre-specified|Number of Participants With Post Operative Infection|The investigators will record the rate of post operative infections in the two groups.|One week postoperatively||||Participants|||Count of Participants
2624958|NCT01919411|Secondary|Lund Kennedy Endoscopic Score|"The Lund Kennedy endoscopic score is a grading system for visually evaluating patient's sinus cavities before and after surgery. It has five measures to score (polyps, edema, discharge, scarring, and crusting).~Scores range from 0 to 20 with higher scores indicating greater sinus disease."|Six weeks postoperatively||||score on a scale||Standard Deviation|Mean
2624959|NCT01919411|Secondary|Lund Kennedy Endoscopic Score|"The Lund Kennedy endoscopic score is a grading system for visually evaluating patient's sinus cavities before and after surgery. It has five measures to score (polyps, edema, discharge, scarring, and crusting).~Scores range from 0 to 20 with higher scores indicating greater sinus disease."|One week postoperatively||||score on a scale||Standard Deviation|Mean
2624960|NCT01919411|Primary|Sinonasal Outcome Test - 22|"The sinonasal outcome test -22 (SNOT-22) is a validated instrument for measuring quality of life outcomes in chronic sinusitis.~Snot-22 scores can range from 0 to 110. Higher scores indicate more severe symptoms."|Six weeks post operatively||||score on a scale||Standard Deviation|Mean
2624961|NCT01919411|Primary|Sinonasal Outcome Test - 22|"The sinonasal outcome test -22 (SNOT-22) is a validated instrument for measuring quality of life outcomes in chronic sinusitis.~Snot-22 scores can range from 0 to 110. Higher scores indicate more severe symptoms."|One week post operatively||||score on a scale||Standard Deviation|Mean
2624962|NCT01919398|Secondary|Pharmacodynamic (PD): Percentage Change From Baseline in Gene Expression Level of Hedgehog (Hh) Regulated Genes (Gli1) in Skin|Percentage Change From Baseline in Gene Expression Level of Hedgehog (Hh) Regulated Genes (Gli1) in Skin.|Baseline, Cycle 1 Day15|All participants who received at least one dose of study drug and evaluable PD data.|||percentage change||Standard Deviation|Mean
2624963|NCT01919398|Secondary|Number of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size (<10 millimeter [mm] short axis). PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.|Baseline Until Disease Progression or Death Due to Any Cause (Up to 29 Months)|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2624964|NCT01919398|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From 0 to 24 Hours (AUC[0-24]) of LY2940680 and a Major Metabolite of LSN3185556|Pharmacokinetics (PK): Area Under the Concentration time Curve From 0 to 24 Hours (AUC[0-24]) of LY2940680 and a Major Metabolite of LSN3185556.|Cycle1 Day1: Predose, 0.5,1,2,4, 6, 8, 10-12 hours; Cycle 1 Day15: Predose, 0.5,1,2,4, 6, 8, 10-12 hours|All participants who received at least one dose of study drug who had evaluable PK data.|||microgram*hour per milliliter(µg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2624965|NCT01919398|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2940680 and a Major Metabolite of LY2940680 (LSN3185556)|Maximum Concentration (Cmax) of LY2940680 and a Major Metabolite of LY2940680 (LSN3185556).|Cycle1 Day1: Predose, 0.5,1,2,4, 6, 8, 10-12 hours; Cycle 1 Day15: Predose, 0.5,1,2,4, 6, 8, 10-12 hours|All participants who received at least one dose of study drug who had evaluable PK data.|||microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2624966|NCT01919398|Primary|Number of Participants With LY2940680 Dose-Limiting Toxicities (DLT)|DLT was defined as an AE during Cycle 1 that is possibly related to the study drug and meets any one of the following criteria based on NCI CTCAE,version 4.0): Grade(Gr) 3 nonhematological toxicity(tox) with exceptions for made for nausea(ns),vomiting(vm),constipation(cp),diarrhea(dr),fatigue(ft),anorexia(an),alopecia or electrolyte-abnormality(eab) that is manageable with appropriate care.If >Gr 3 ns,vm,cp,dr,ft,an,or eab persists for>2 days with maximal supportive intervention,the event was declared a DLT.Transient(≤5 days) Gr 3 liver enzyme elevations,without evidence of other hepatic injury.Gr 3 thrombocytopenia(throm) requiring platelet transfusion or Gr 4 throm.Gr 4 neutropenia of >5 days duration.Febrile neutropenia(ANC<1,000/mm3 with a single temperature(temp) of >38.3 degrees C or a sustained temp of ≥38 degrees C for more than one hour).Tox requiring dose omissions of >5 days or significant & deemed by the primary investigator(PI) & sponsor(sp) to be dose limiting .|Cycle 1 (28 Days)|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2624967|NCT01919307|Secondary|Trend for Auricular Acupuncture to Reduce NES Frequency|Of subjects completing the 8 week active treatment period, we will compare each subject's 1 month baseline frequency with frequency immediately upon completion of the active treatment period, and at 1 month follow up (3 months after baseline)|16 weeks||||Number of Seizures per Week||Standard Deviation|Mean
2624968|NCT01919307|Secondary|Compliance Rates of NES Seizure Diary|For each subject enrolled, we will measure the percentage of diary entries each patient completed over the four month study period.|16 Weeks||||percentage of completed diary entries||Standard Deviation|Mean
2624969|NCT01919307|Secondary|Adverse Events|We will report the types and rates of any adverse events collected from subject diaries.|16 Weeks||||Adverse Events|Adverse Events||Count of Units
2624970|NCT01919307|Primary|Completion Rate of Auricular Acupuncture in Patients With NES|Of subjects who receive the first Auricular Acupuncture treatment, we will measure the percentage that goes on to complete the entire 8 week active treatment period.|8 Weeks||||Participants|||Count of Participants
2624971|NCT01919229|Secondary|Change From Baseline in Expression of Cyclin-Dependent Kinase 1 (CDK1)||Baseline, Day 15|Since the study was terminated, no efficacy data was obtained.||||||
2624972|NCT01919229|Secondary|Correlation Between PK Concentrations and ECG Changes|Correlation between the QTc interval change from baseline and plasma concentrations of LEE011 and/or any relevant metabolites|Day 14|Since the study was terminated, no efficacy data was obtained.||||||
2624973|NCT01919229|Secondary|Change in ECG Morphology||Baseline, Day 14|Since the study was terminated, no efficacy data was obtained.||||||
2624974|NCT01919229|Secondary|PK (Pharmacokinetics) Parameters, Including But Not Limited to, Cmax, Tmax, AUClast for LEE011 (and Any Relevant Metabolites) and Letrozole.||Days 1, 8, 14 and 15|Since the study was terminated, no efficacy data was obtained.||||||
2624975|NCT01919229|Secondary|Change From Baseline in Expression of Retinoblastoma Protein (pRB)||Baseline, Day 15|Since the study was terminated, no efficacy data was obtained.||||||
2624976|NCT01919229|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters||Baseline, Day 14|Since the study was terminated, no efficacy data was obtained.||||||
2624977|NCT01919229|Secondary|Safety and Tolerability of the Combination|Occurrence, frequency and severity of adverse events (AEs), laboratory abnormalities|Up to 30 days after the last dose|Since the study was terminated, no efficacy data was obtained, but see Adverse Events (AE) section for all AEs collected.|||Participants|||Number
2624978|NCT01919229|Primary|Cell Cycle Response Rate Per Cell Proliferation Marker Ki67|Cell cycle response rate is defined by proportion of patients with natural logarithm of Ki-67 levels (expressed as percentage of baseline values) of less than 1 at the time of surgery. Since the trial was prematurely terminated, no statistical analysis was done.|Day 1, Day15|Since the study was terminated, no efficacy data was obtained.||||||
2624979|NCT01919216|Primary|Hamilton Rating Scale for Depression|The patient is rated by a clinician among 24 dimensions with a score on a 3 or 5 point scale. A score of 0-9 is considered to be normal. Score between 10-18 is considered as mild depression, Scores between 19-26 indicate moderate, scores between 27-34 indicate severe, and score between 35-75 indicate very severe depression.|8 weeks|54 subjects participated in the study, of whom 4 (2 in open track, 1 in placebo track - citalopram, 1 in placebo track - placebo) were lost to follow-up prior to taking the study medication and were excluded from the analyses.|||units on a scale||Standard Deviation|Mean
2624980|NCT01918800|Secondary|Timed 25 Foot Walk (T25-FW)|The time to walk 8 meters or 25 feet is strongly related to its ordinal counterpart the Ambulation Index (Spearman r = 0.91), without the variability that the ordinal scale reflects.T25-FW was used in this study to measure ambulation status and as an additional measure of mobility. The score for the T25-FWis the average of the two completed trials in seconds|4 months||||seconds||Standard Deviation|Mean
2624981|NCT01918800|Secondary|Pittsburgh Sleep Quality Index (PSQI)|"The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a l-month time interval. Nineteen individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score between 0-21. Higher scores indicate worse sleep quality."|4 months||||units on a scale||Standard Deviation|Mean
2624982|NCT01918800|Secondary|Rapid Assessment of Physical Activity (RAPA)|"The self-report, retrospective Rapid Assessment of Physical Activity (RAPA) was developed to provide an easily administered and interpreted means of assessing levels of physical activity among adults older than 50 years. The RAPA is an easy-to-use, valid measure of physical activity for use in clinical practice with older adults. A tool for older adults will be easy to use for people with MS who may not be regular exercisers. Each question has a 'Yes' or 'No' option. The total score of the first seven items is out of 7; participants choose which question corresponds to their activity level. Any score less than 6 is considered suboptimal. From these values we provided a percentage of the number of people exercising optimally in the RAPA Cardiovascular.~Strength training and flexibility are scored separately (strength training = 1, flexibility = 2, both = 3). Based on total scores we provided a percentage of people at optimum strength and flexibility."|4 months||||Participants|||Count of Participants
2624983|NCT01918800|Secondary|SF-36|The SF-36 is a validated measure of health-related quality of life. It is sensitive to change, has appropriate psychometric properties and is frequently used in MS studies. Measures of health-related quality of life are recommended in the systematic review of self-management in neurological disorders. The range for the physical component score is 13.6-61.9. The range for the mental component scores is 15.6-70.0.|4 months||||units on a scale||Standard Deviation|Mean
2624984|NCT01918800|Secondary|Beck Depression Inventory II (BDI-II)|The self-report, retrospective BDI-II is a validated 21-item self-report measure of depression widely used in MS studies . Each item is scored between 0 and 3. It is reported to have good reliability (Cronbach's alpha of .81) and validity. Assessing for depression is part of the inclusion/exclusion criteria. Excluding subjects with severe depression is necessary to avoid confounding effects of fatigue and depression. Score range (0-63). Higher scores indicate greater depression.|4 months||||units on a scale||Standard Deviation|Mean
2624985|NCT01918800|Secondary|Multiple Sclerosis Self Efficacy Scale|The self-report, retrospective MSSE is an 18-item scale of self-efficacy specifically designed for MS patients. This easy to use self-report measure demonstrates internal consistency estimates of about .89 for the full scale and a .75 test-retest correlation. Higher scores on the MSSE indicate higher self-efficacy. Scores range from 180-1800.|4 months||||units on a scale||Standard Deviation|Mean
2624986|NCT01918800|Primary|Modified Fatigue Impact Scale|The self-report, retrospective MFIS measures fatigue symptoms. The full-length MFIS consists of 21 items scored 0-4 for a total score between 0 and 84 and has a coefficient alpha of .81. The MFIS provides a total score and scores for each of three subscales (physical, cognitive and psychosocial) and lower scores on the MFIS and its subscales indicate less fatigue. This is the primary outcome measure for the proposed study and is widely used to assess fatigue in MS.|4 months||||units on a scale||Standard Deviation|Mean
2624987|NCT01918774|Secondary|Work Productivity|"The Work and Health Interview (Stewart et al., 2003) will assess work productivity for participants who are currently working. Work productivity will be measured by 7 self-report items (e.g., During the past 2 weeks, how often did you lose concentration at work?) scored on a Likert scale ranging from 0, none of the time to 4, all the time . Total scores are calculated using the mean of all items and then converted to quarter percentages, yielding a final work productivity score ranging from 0 to 100. Higher scores indicate more disruption and lower work productivity. Lower scores indicate less work disruption and higher work productivity. The Work and Health Interview has been used widely in patients with chronic conditions, demonstrating good psychometric properties."|baseline to 12 week follow-up|Those who obtained competitive work during the 12 week follow up period|||score on scale||Standard Deviation|Mean
2624988|NCT01918774|Secondary|Recovery Assessment Scale|"Global perceived recovery will be assessed by the Recovery Assessment Scale (Corrigan et al., 1999), a 41 item scale designed to assess perceptions of recovery held by persons with mental illness. Because perceptions of recovery may be amenable to CBT and have been associated with key functional outcomes, including employment, it is appropriate to examine in this study. The self-report RAS is scored on a 1 to 5 Likert scale from 'strongly disagree' to 'strongly agree' (e.g., I have a desire to succeed.). The RAS has five factors including confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and no domination by symptoms. Total scores range from 41 to 205, with higher scores indicating stronger perceptions of personal recovery. The RAS has shown good test retest reliability, internal consistency, and criterion-related validity (Corrigan et al., 1999)."|baseline to 12 week follow up|All participants who completed the study are included.|||score on a scale||Standard Deviation|Mean
2624989|NCT01918774|Secondary|Rosenberg Self Esteem Scale|The Rosenberg self esteem scale, a 10-item Likert scale (1-strongly agree; 2-agree; 3-disagree; 4-strongly disagree) will examine self esteem (Rosenberg, 1965); higher scores on the RSES indicate higher levels of a unidimensional self-esteem construct. The RSES has been used extensively in samples of persons with and without mental illness and across various ethnic and cultural groups, demonstrating good reliability and validity (e.g. Link et al., 2014). Scores range from 10 to 40, with lower scores indicate higher self esteem.|baseline to 12 week follow up|All participants who completed the study are included.|||score on a scale||Standard Deviation|Mean
2624999|NCT01918761|Secondary|Progression-free Survival|Progression-free survival (PFS) defined as time from start of Dacomitinib to date of progression or date of death from any cause, whichever occurred first. Patients without recorded progression or death were censored at the last date they were known to have not progressed. Patients were followed up for progression-free survival for 24 month after end of Treatment.|Up to progression or death due to any cause. The study was suspended after 36 months|All enrolled participants|||months||95% Confidence Interval|Median
2624990|NCT01918774|Secondary|Work Extrinsic and Intrinsic Motivation Scale|Motivation to work will be measured by the Work Extrinsic and Intrinsic Motivation Scale (WEIMS) based on self determination theory; the 18-item WEIMS measures six empirically grounded domains of motivation, including 1). intrinsic motivation; 2). integrated regulation motivation; 3) identified regulation motivation; 4) introjected regulation; 5) external regulation ; 6) amotivation . The WEIMS is scored on a 1 to 7 Likert scale ('Does not correspond at all' to 'Corresponds exactly'). Mean WEIMS scores range from 1 to 7 with higher scores indicating higher levels of motivation. The WEIMS has been shown to have strong predictive validity, correlating highly with work behaviors (e.g., Tremblay et al., 2009).|baseline, 12 week follow up|Participants who completed the study were included.|||score on a scale||Standard Deviation|Mean
2624991|NCT01918774|Secondary|Quality of Life Interview|Prior studies in the mental health domain have demonstrated that quality of life improves in response to CBT treatment, therefore, as discussed above with regard to symptoms, quality of life may be enhanced in response to CBT treatment, regardless of the impact on work outcomes. The Quality of Life Interview (QOLI; Lehman, 1988), developed specifically for a psychiatric population, will measure veteran quality of life. The investigators will use the 17 items that assess subjective quality of life, including global life satisfaction and sub-domains--living situation, daily activities and functioning, family relations, social relations, legal and safety issues, and health. The QOLI has been shown to have very good reliability and validity in adult outpatients (Lehman, 1988; Lehman et al., 1993). This study focused on the health quality of life domain, comprised of 6 items scores on a 1 to 7 likert scale. Scores range from 6 to 42 with higher scores indicating higher quality of life.|baseline, 12 week follow up|Participants who completed the study were included.|||score on a scale||Standard Deviation|Mean
2624992|NCT01918774|Secondary|Work Related Self-efficacy Scale|Work related self-efficacy is defined as one's perceived ability and confidence to perform work activities. Given that the adapted CBT program will seek to improve these perceptions, the investigators will measure this construct using the Work-Related Self-efficacy Scale (Waghorn et al., 2005). The 37-item self-report scale yields a total score on a 0 to 100 point scale, in which higher scores indicate stronger self efficacy related to work. Studies suggest that the scale has adequate to good reliability and validity in adults with mental illness living in the community (Harris et al., 2010).|baseline, 12 week follow up|Participants who completed the study are included.|||score on a scale||Standard Deviation|Mean
2624993|NCT01918774|Secondary|Beck Anxiety Inventory (BAI)|"Symptoms of anxiety will be assessed using the Beck Anxiety Inventory (Beck & Steer, 1993). The BAI has 21 items, each describing a psychological or physiological symptom of anxiety (e.g., Nervous) that respondents rate on a 0 to 3 Likert Scale (not at all to severely) based on how much they have been bothered by the symptom within the past week. Total scores range from 0 to 63 with higher scores indicating more severe anxiety symptoms. The BAI has been widely used to assess anxiety in adults with mental illness and has been demonstrated to have strong psychometric properties (e.g., Fydrich, Dowdall, & Chambless, 1992)."|baseline, 12 week follow up|Participants who completed the study were included.|||score on a scale||Standard Deviation|Mean
2624994|NCT01918774|Secondary|Beck Depression Inventory (BDI-II)|Change in levels of depression will be assessed using the Beck Depression Inventory, Second Edition (BDI-II; Beck, Steer, & Brown, 1996). The BDI-II contains 21 items that assess the various mood and bodily symptoms of depression; participants are asked to respond based on symptoms during the past two weeks. There are four response options for each item reflecting increasing severity of depression; the total score is obtained by summing up the scores on each item (0-3). Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms. The BDI-II is the gold standard tool to assess depression in both non-clinical and psychiatric populations and has been shown to have excellent reliability and validity across several prior studies (e.g., Yin & Fan, 2000).|baseline, post intervention (12 weeks)|All participants who completed the intervention are included in the analysis|||score on scale||Standard Deviation|Mean
2624995|NCT01918774|Secondary|Positive and Negative Syndrome Scale (PANSS)|The Positive and Negative Syndrome Scale (PANSS) has been used extensively in studies of psychiatric rehabilitation and CBT. The PANSS (Kay et al., 1987) is comprised of 30 items scored on a 1 to 7 Likert scale, in which the total score is obtained by adding up scores on all 30 items (total scores range from 30 to 240). Higher scores indicate more severe symptoms. The PANSS has adequate reliability and validity in adults with severe mental illness (Kay et al., 1987).|baseline, 12 week follow up|Participants who completed the study were included.|||score on a scale||Standard Deviation|Mean
2624996|NCT01918774|Secondary|Work Effectiveness|"The Work and Health Interview (Stewart et al., 2003) will assess work effectiveness and work productivity for participants who are currently working (unemployed participants will not complete these measures). Work effectiveness will be measured by one self-report item- On days that you worked during the past 4 weeks, how effective were you in your job on average? Please tell me, on a scale of 0 to 100, where 0% means that you were not at all effective, and 100% means that you were completely effective, how effective would you say you have been on your job during the past 4 weeks?. Higher scores indicate more work effectiveness. The Work and Health Interview has been used widely in patients with chronic conditions, demonstrating good psychometric properties."|baseline and 12 week follow up scores|Participants who worked in competitive jobs during the 12 week follow up were included.|||percentage of work effectiveness score||Standard Deviation|Mean
2624997|NCT01918774|Primary|Number of Participants With Steady Competitive Work Attainment|Steady competitive work attainment, defined as working at least half the follow up period, will be assessed at the 6 month follow up.|6 month follow up|All participants who completed the study are included in analysis.|||Participants|||Count of Participants
2624998|NCT01918774|Primary|Change in Competitive Employment|Competitive employment is standard in studies of employment in persons with mental illness and will include change in the total number of weeks worked in competitive jobs between baseline and the 6 month follow-up point.|Change from baseline competitive employment to 6 month follow up competitive employment|Open trial treatment, all participants who completed the study are included.|||weeks||Standard Deviation|Mean
2625000|NCT01918761|Secondary|Overall Survival|Overall survival (OS) defined as time from start of Dacomitinib to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. Patients were followed up for survival for 24 month after end of Treatment.|until date of death. The study was suspended after 36 months.|All enrolled participants|||months||95% Confidence Interval|Median
2625002|NCT01918761|Primary|Dose Limiting Toxicities (DLTs)|The primary objective of this study is to determine the maximal tolerated dose (MTD) of the combination pemetrexed + dacomitinib by the incidence of dose limiting toxicities (DLTs).|From start of treatment to end of treatment or death, whichever occurs first. The study was suspended after 36 months.|All enrolled participants|||percentage of participants||95% Confidence Interval|Number
2625003|NCT01918371|Secondary|Percentage of Phakic Patients With Cataract Surgery in the Study Eye|Phakic patients have intraocular lens implants.|4 Years|All phakic participants with data available.|||percentage of participants|||Number
2625004|NCT01918371|Secondary|Percentage of Participants Undergoing Incisional Glaucoma Surgery in the Study Eye||4 Years|All participants with data available.|||percentage of participants|||Number
2625005|NCT01918371|Secondary|Percentage of Participants Undergoing Glaucoma Laser Surgery in the Study Eye||4 Years|All participants with data available.|||percentage of participants|||Number
2625006|NCT01918371|Secondary|Percentage of Participants With No Change in BCVA From Baseline in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).|Baseline, Up to 4 Years|All participants with data available.|||percentage of participants|||Number
2625007|NCT01918371|Secondary|Percentage of Participants With a Gain (Increase) in BCVA of ≥1 Line From Baseline in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). A gain of 1 or more lines read correctly from Baseline indicates an improvement of vision.|Baseline, Up to 4 Years|All participants with data available.|||percentage of participants|||Number
2625008|NCT01918371|Secondary|Percentage of Participants With a Loss (Decrease) in BCVA of ≥1 Line From Baseline in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). A loss of 1 or more lines read correctly from Baseline indicates a worsening of vision.|Baseline, Up to 4 Years|All participants with data available.|||percentage of participants|||Number
2625009|NCT01918371|Secondary|Percentage of Participants Undergoing Panretinal Photocoagulation (PRP) Surgery in the Study Eye||4 Years|All participants with data available.|||percentage of participants|||Number
2625010|NCT01918371|Secondary|Percentage of Participants Undergoing Focal Laser Surgery in the Study Eye||4 Years|All participants with data available.|||percentage of participants|||Number
2625011|NCT01918371|Secondary|Percentage of Participants Switching Among Different Anti-VEGF Agents in the Study Eye|Participants who switched among the different Anti-VEGF Agents: bevacizumab, ranibizumab and aflibercept.|Up to 4 Years|All participants with data available.|||percentage of participants|||Number
2625012|NCT01918371|Secondary|Percentage of Participants Switching to a Second or Third Anti-VEGF Agent After First Injection in the Study Eye||UP to 4 Years|All participants with data available.|||percentage of participants|||Number
2625013|NCT01918371|Secondary|Number of Intravitreal Anti-VEGF Injections in the Study Eye|To be included in the time period analysis, patients must have been enrolled on the study for at least a minimum of 0 weeks, 24 weeks, 50 weeks, 100 weeks, and 150 weeks, respectively, and must have received at least 1 injection during that time period.|0-6 Months, 7-12 Months, Years 1,2,3|All participants with data available.|||injections||Standard Deviation|Mean
2625014|NCT01918371|Secondary|Time Between Anti-VEGF Injections in the Study Eye|The mean time in months between anti-VEGF Injections.|4 Years|All participants with data available.|||months||Standard Deviation|Mean
2625015|NCT01918371|Secondary|Time to Improvement to Both 20/40 or Better in BCVA and Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye|Kaplan-Meier estimates of the time to improvement to Both 20/40 or Better in BCVA and Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|4 Years|All participants with available data.|||months||Full Range|Median
2625016|NCT01918371|Secondary|Time to Improvement in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye|Kaplan-Meier estimates of the time to improvement in months in CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|4 Years|All participants with available data.|||months||Full Range|Median
2625017|NCT01918371|Secondary|Time to Improvement in BCVA to 20/40 or Better in the Study Eye|Kaplan-Meier estimates of the time to Improvement in months in BCVA to 20/40 or Better. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly.|4 Years|All participants with available data.|||months||Full Range|Median
2625018|NCT01918371|Secondary|Time to Improvement of ≥3 Lines in BCVA in the Study Eye|Kaplan-Meier estimates of the time in months to improvement of ≥3 lines in BCVA. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).|4 Years|All participants with available data.|||months||Full Range|Median
2625019|NCT01918371|Secondary|Time to Improvement of ≥2 Lines in BCVA in the Study Eye|Kaplan-Meier estimates of the time in months to improvement of ≥2 lines in BCVA. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).|4 Years|All participants with available data.|||months||Full Range|Median
2625020|NCT01918371|Secondary|Change From Baseline in CRT by OCT in the Study Eye|CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement.|Baseline, Up to 4 Years|All participants with data available.|||µm (microns)||Standard Deviation|Mean
2625100|NCT01917344|Primary|Phenylalanine Level in the Brain as Determined by MR Spectroscopy and in Blood|Brain Phe levels (umol/L) using MRI correlated spectroscopy and Blood Phe levels (umol/L) obtained on the same day.|During period of evaluation, approximately 8 hours||||umol/L||Standard Deviation|Mean
2625021|NCT01918371|Secondary|Percentage of Participants With an Increase From Baseline of ≥3 Lines in BCVA in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 3 or more lines read correctly from Baseline indicates improvement.|Baseline, Up to 4 Years|All participants with data available.|||percentage of participants|||Number
2625022|NCT01918371|Secondary|Percentage of Participants With an Increase From Baseline of ≥2 Lines in BCVA in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 2 or more lines read correctly from Baseline indicates improvement.|Baseline, Up to 4 Years||||percentage of participants|||Number
2625023|NCT01918371|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). A positive change from Baseline indicates improvement.|Baseline, Up to 4 Years|All participants with data available.|||lines||Standard Deviation|Mean
2625024|NCT01918371|Secondary|Mean BCVA in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best).|UP to 4 Years|All participants with data available.|||lines||Standard Deviation|Mean
2625025|NCT01918371|Secondary|Percentage of Participants With Both BCVA 20/40 or Better or CRT ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to 4 Years|All participants with data available.|||percentage of participants|||Number
2625026|NCT01918371|Secondary|Percentage of Participants With CRT of ≤250 µm on TD OCT or ≤300 µm on SD OCT in the Study Eye|CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to 4 Years|All participants with data available.|||percentage of participants|||Number
2625027|NCT01918371|Secondary|Percentage of Participants With BCVA of 20/40 or Better in the Study Eye|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly|Up to 4 Years|All participants with data available.|||percentage of participants|||Number
2625028|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 11|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 11 (Up to 4 Years)|All participants with data available up to time of Injection 11.|||percentage of participants|||Number
2625029|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 10|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 10 (Up to 4 Years)|All participants with data available up to time of Injection 10.|||percentage of participants|||Number
2625030|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 9|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 9 (Up to 4 Years)|All participants with data available up to time of Injection 9.|||percentage of participants|||Number
2625031|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 8|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 8 (Up to 4 Years)|All participants with data available up to time of Injection 8.|||percentage of participants|||Number
2625032|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 7|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 7 (Up to 4 Years)|All participants with data available up to time of Injection 7.|||percentage of participants|||Number
2625075|NCT01917812|Primary|Mean Daily Step Count|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from baseline mean daily step count at 3 weeks (end of unblinded digital activity tracker intervention)||||steps per day||Standard Deviation|Mean
2625033|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 6|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 6 (Up to 4 Years)|All participants with data available up to time of Injection 6.|||percentage of participants|||Number
2625034|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 5|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 5 (Up to 4 Years)|All participants with data available up to time of Injection 5.|||percentage of participants|||Number
2625035|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 4|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 4 (Up to 4 Years)|All participants with data available up to time of Injection 4.|||percentage of participants|||Number
2625036|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 3|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 3 (Up to 4 Years)|All participants with data available up to time of Injection 3.|||percentage of participants|||Number
2625037|NCT01918371|Primary|Percentage of Participants With Best Corrected Visual Acuity (BCVA) of 20/40 or Better and Central Retinal Thickness (CRT) ≤250 µm on Time Domain (TD) Optical Coherence Tomography (OCT) or ≤300 µm on Spectral Domain (SD) OCT Up to Injection 2|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). 20/40 or better is equivalent to 14 or more lines read correctly. CRT was measured using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina performed in the study eye after pupil dilation.|Up to Time of Injection 2 (Up to 4 Years)|All participants with data available up to time of Injection 2.|||percentage of participants|||Number
2625038|NCT01918332|Primary|LDL-C Percentage Changes at Week 8 From Baseline|LDL-C percentage changes of the rosuvastatin 20mg and rosuvastatin placebo groups at Week 8 from baseline|8 weeks|FAS|||percent change||95% Confidence Interval|Least Squares Mean
2625039|NCT01918332|Primary|sitDBP Changes at Week 8 From Baseline|sitDBP changes of the valsartan 160mg and valsartan placebo groups at Week 8 from baseline|8 weeks|FAS|||mmHg||95% Confidence Interval|Least Squares Mean
2625040|NCT01918306|Other Pre-specified|Correlation of the Presence of PIK3CA Mutations in the Tumor With Time to Tumor Progression.|Examining tumor tissue for PI3K mutations and correlating this statistically with clinical outcomes including time to tumor progression.|2 years|||||||
2625041|NCT01918306|Secondary|Time to Progression - (Phase II)|Time to Progression (TTP) is calculated with the corresponding 95% confidence interval at the dose recommended for phase II. TTP is defined as the time from randomization until objective tumor progression, this does not include deaths unrelated to disease progression.|From time of randomization to disease progression, up to 104 weeks||||days to progression||Full Range|Median
2625042|NCT01918306|Secondary|Clinical Benefit Rate - (Phase II)|"Clinical Benefit Rate (CBR) is defined as complete response (CR) plus partial response (PR) plus stable disease (SD) for 6 months.~Clinical Benefit Rate (CBR) is calculated with the corresponding 95% confidence intervals at the dose recommended for phase II.~Response and progression will be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 performed at baseline and every 8 weeks will be compared."|at 32 weeks|Study closed early and response and progression were not evaluated at 32 weeks.||||||
2625043|NCT01918306|Secondary|Number of Patients With Dose-limiting Toxicities Per NCI Common Terminology for Adverse Events (CTCAE) - (Phase Ib)|Number of patients with Grade 3 and 4 toxicities per NCI Common Terminology for Adverse Events (CTCAE) version 4.0 requirements.|During the first 4 weeks|Less than 2 patients in cohort 1 and 2 experienced DLT, therefore no patients enrolled in arm 1PHIbB.|||participants|||Number
2625044|NCT01918306|Primary|Percentage of Patients Achieving Overall Response - (Phase II)|"The primary efficacy endpoint is overall response rate (ORR) of cisplatin + GDC-0941 versus cisplatin alone in patients with AR- TN MBC. ORR is defined as the percentage of subjects achieving complete response (CR) plus partial response (PR) as their best response by RECIST version 1.1 for targeted lesions and assessed by CT, MRI scan.~Objective responses, was estimated by the overall tumor burden at baseline (targeted lesions) in which subsequent measurements were performed every 8 weeks using the Solid Tumor Response Criteria (RECIST) v1.1 were compared. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."|at 8 weeks|Phase 1-Initial and Max tolerated dose of GCD-0941 was the same, no dose de-escalation occurred. Phase 2, 1 of the 2 patients from the Cisplatin only arm did crossover to the Crossover Cisplatin and GDC-0941 arm. 3 patients randomized to Cisplatin + GDC -0941 arm, and 1 crossover patient, for a total of 4 patients who received Cisplatin+GDC-0941.|||Participants|||Count of Participants
2625045|NCT01918306|Primary|Maximum Tolerated Dose(MTD) of GDC-0941 and Recommended Phase II Dose of GDC-0941 Given in Combination With Cisplatin. - (Phase Ib)|"GDC-0941 dose will start at 260 mg (maximum dose). De-escalation of the intensity of the dose (if necessary) will proceed among cohorts of 3 patients according to a standard 3+3 algorithm beginning at the highest dose level of GDC-0941 260mg.~MTD is defined as the highest dose at which a DLT is experienced >= 1 out of 6 patients.~A cohort of 3 patients was initially enrolled in the GDC-0941 arm at dose 260mg PO days 2-6, 9-13, 16-20, 23-27 of 28 day cycle~If no patient in the first cohort of 3 experiences a DLT, an additional cohort of 3 patients will be treated at the same dose level.~If 1 patient experiences a DLT in the first cohort, an additional cohort of 3 patients will be treated at the same dose level.~If ≤1 patient has a DLT in 6 treated at this same dose, this will be considered a tolerable dose to move to phase II.~If 2 or more patients in 3 or 6 patients treated at a given dose experience DLT, the dose will be de-escalated to the next lower dose level."|4 weeks|A cohort of 3 was enrolled at dose 260mg. No DLT was found. Then a second cohort of 260mg was enrolled. One of them experienced DLT.|||mg|||Number
2625046|NCT01918189|Secondary|Beck Depression Inventory|"Depressive symptom severity was assessed using the 21-item Beck Depression Inventory. Scores range from 0 - 63. Higher scores indicate more severe depression symptomatology. Lower scores correspond to better outcomes (i.e., less depressive symptom severity).~Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value)."|baseline and 10 weeks post-baseline||||score on a scale||95% Confidence Interval|Least Squares Mean
2625047|NCT01918189|Secondary|Medical Outcomes Study Sleep Scale|"The MOS Sleep Scale is a 12 item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, awaken short of breath or with headache, adequacy of sleep, somnolence, a problems index 1 and a problems index 2). An additional single item assesses quantity of sleep. The sleep domains and problems index are scored on a 0 - 100 possible range, and higher scores indicate more of the concept being measured. Lower scores on sleep disturbance, for example, reflect less disturbed sleep, which is a better outcome.~Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value)."|baseline and 10 weeks post-baseline||||score on a scale||95% Confidence Interval|Least Squares Mean
2625048|NCT01918189|Secondary|Multidimensional Fatigue Inventory|"General fatigue scale reported. Fatigue was assessed using the Multidimensional Fatigue Inventory (MFI), which is a 20 item measure that can be scored to produce 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and how subscale statements regarding fatigue represent their experiences. Score range from 4 to 20. Higher total scores correspond with more acute levels of fatigue. Lower scores correspond to better outcomes.~Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value)."|baseline and 10 weeks post-baseline||||score on a scale||95% Confidence Interval|Least Squares Mean
2625049|NCT01918189|Secondary|Profile of Mood States|"Total mood symptoms score reported. The 65-item Profile of Mood States (POMS) is a multidimensional measure of emotional functioning designed to assess six dimensions of mood over the past week, including today. Each item is scored on a 0-5 Likert scale, where 0= not at all and 5= extremely. Total Mood Disturbance score ranges from 0 to 200. Higher scores reflect poorer functioning. Lower scores correspond to better outcomes.~Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value)."|baseline and 10 weeks post-baseline||||score on a scale||95% Confidence Interval|Least Squares Mean
2625050|NCT01918189|Secondary|Numeric Rating Scale of Pain Intensity|"self-report measure of pain intensity measured on a 0-10 likert scale. Participants are asked, Please rate your pain by indicating the number that best describes your average pain over the past week on a 0 (no pain) to 10 (pain as bad as you can imagine) scale. Scores of 1-3 reflect mild pain, 4-6 moderate pain, and 7-10 severe pain. Lower scores reflect less pain, and therefore, better outcome.~Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value)."|baseline and 10 weeks post-baseline||||units on a scale||95% Confidence Interval|Least Squares Mean
2625051|NCT01918189|Primary|Multidimensional Pain Inventory Interference Subscale|"Self-report measure of pain-related functional interference. The 9-item Interference subscale, scores ranging from 0-6, of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI)-Interference scale assesses pain-related interference. Lower scores indicate less pain-related interference (i.e., better outcome). A reduction in WHYMPI-Interference Scale scores of 0.6 or greater has been identified as an indicator of meaningful improvement in physical functioning.~Outcome was calculated as a change from baseline score to 10-week post-baseline score (i.e., 10 weeks post-baseline value minus baseline value)."|baseline and 10 weeks post-baseline|17 of the 58 participants who completed baseline did not complete 10-week post-baseline assessment (study endpoint)|||score on a scale||95% Confidence Interval|Least Squares Mean
2625052|NCT01918085|Primary|Peel Force|"The peel force was measured with a tensile tester which measured the force needed to remove the the adhesive strip from the skin with a constant speed 304mm/min and a mean angel of 90 degrees.~The peel force was measured on all participants in the flow module. However, sometimes the measurements failed and therefore did not provide a result. In example a wheel chair user was included and non of peel force measurements were succesful on the subject. The rest of the failed measurements were distributed randomly between the subjects."|1 hour|"Some of the measurements failed. i.e one subject was a wheel chair user and the peel force could not be measured on this person.~Only the measurements that did not fail were included in the analysis"|||Newton||Standard Deviation|Mean
2625053|NCT01918072|Secondary|Quality of Urinary Incontinence Care|Quality of urinary incontinence care as defined by adherence to practice guidelines. This measure is the mean percent of applicable quality indicators for whom the guideline adherent action was performed by primary care providers.|28-month study timeframe|The analysis included primary care providers providing care for urinary incontinence episodes during the 28-month study timeframe.|||percent of care adherent to guidelines||95% Confidence Interval|Mean
2625054|NCT01918072|Secondary|Quality of Menopausal Symptoms Care|Quality of menopausal symptoms care as defined by adherence to practice guidelines. This measure is the mean percent of applicable quality indicators for whom the guideline adherent action was performed by primary care providers.|28-month study timeframe|The analysis included primary care providers providing care for menopausal symptoms episodes during the 28-month study timeframe.|||percent of care adherent to guidelines||95% Confidence Interval|Mean
2625055|NCT01918072|Secondary|Quality of Abnormal Uterine Bleeding Care|Quality of abnormal uterine bleeding care as defined by adherence to practice guidelines. This measure is the mean percent of applicable quality indicators for whom the guideline adherent action was performed by primary care providers.|28-month study timeframe|The analysis included primary care providers providing care for abnormal uterine bleeding episodes during the 28-month study timeframe.|||percent of care adherent to guidelines||95% Confidence Interval|Mean
2625056|NCT01918072|Secondary|Provider Referral Behavior|This measure is the number of providers that changed their referral plan for an in-person specialist-to-patient visit after an electronic consultation.|1-7 days after receiving a response to the electronic consult||||Participants|||Count of Participants
2625057|NCT01918072|Secondary|Change in Quality of Women's Health Care (Controlled Trial Steps)|Quality of care as defined by adherence to practice guidelines. This measure is the difference in the percent of applicable quality indicators for whom the guideline adherent action was performed by primary care providers, with each subsequent step, over the course of the controlled trial.|Baseline through four months after the final time step when participants entered into the intervention (28 months)||||percent of care adherent to guidelines||Standard Error|Mean
2625058|NCT01918072|Primary|Change in Quality of Women's Health Care (Control Period vs. Intervention Period)|Quality of care as defined by adherence to practice guidelines. This measure is the difference in the percent of applicable quality indicators for whom the guideline adherent action was performed by primary care providers at baseline versus after entering into the intervention.|Baseline through four months after the final time step when participants entered into the intervention (28 months)||||percent of care adherent to guidelines||Standard Error|Mean
2625059|NCT01918033|Secondary|Change From Baseline in Eye Symptom Score Reported in Participant Diaries|Participants evaluated themselves in their daily allergy diaries for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for participant-rated eye symptom score.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2625060|NCT01918033|Secondary|Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries|Participants evaluated themselves in their daily allergy diaries for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Each nasal symptom sub-score could range from 0 to 3, with a higher sub-score indicating more frequent/severe nasal symptoms.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for participant-rated nasal symptom score.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2625061|NCT01918033|Secondary|Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator|The investigator interviewed participants at Baseline, Day 3, Week 1 and Week 2 to evaluate interference with daily activities according to the following scale: 0=none, 1=nasal symptom interferes with daily activities from time to time (+), 2=between 1 and 3 (++), and 3=nasal symtom interferes with daily activity often (+++). Interference with daily activities scores could range from 0 to 3, with a higher score indicating greater interference with daily activities.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for interference with daily activities.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2625062|NCT01918033|Secondary|Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator|The investigator comprehensively evaluated participants on global improvement according to 5 grades: 1=remarkably improved, 2= moderately improved, 3=slightly improved, 4=unchanged, and 5=aggravated. The number of participants who were evaluated as remarkably improved and moderately improved was calculated.|Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for global improvement.|||Participants|||Number
2625063|NCT01918033|Secondary|Change From Baseline in Eye Symptom Score Assessed by the Investigator|The investigator interviewed and examined participants for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for eye symptom score as assessed by the investigator.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2625064|NCT01918033|Secondary|Change From Baseline in Nasal Finding Score Assessed by the Investigator|The investigator conducted rhinoscopic examinations on participants to evaluate: swelling of inferior nasal concha mucosa (INCM) (score of 0=none to 3=middle nasal concha is not visible), coloring of inferior nasal concha mucosa (INCM) (score of 0=normal to 3=pale), and nasal discharge production (NDP) (score of 0=none to 3=congesting). The score for each nasal finding component could range from 0 to 3, with a higher score indicating more severe symptoms.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for nasal finding score.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2625090|NCT01917656|Primary|Change in Fructosamine From Start of Ramadan to End of Ramadan|The level of fructosamine in the blood was used to assess the glycaemic control in the patients during the time period described- from start of Ramadan (day -1, visit 8) to end of Ramadan (day 29, visit 12).|Day -1, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.|||umol/L||Standard Deviation|Mean
2625091|NCT01917526|Secondary|The Causes of Hypoxemia|Causes of hypoxemia in each participant in PACU will be recorded|In PACU (1 hr after anesthesia)||||causes of hypoxemia|||Number
2625065|NCT01918033|Secondary|Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator|The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attackes; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores could range from 0 to 3, with a higher nasal symptom sub-score indicating more frequent/severe nasal symptoms.|Baseline and Day 3, Week 1, Week 2|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for nasal symptom sub-scores as assessed by the investigator.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2625066|NCT01918033|Secondary|Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1|The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.|Baseline and Day 3, Week 1|The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for TNSS.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2625067|NCT01918033|Primary|Number of Participants Discontinuing Study Drug Due to an AE|An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized.|Up to Week 2|The ASaT population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
2625068|NCT01918033|Primary|Number of Participants Experiencing an Adverse Event (AE)|An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who experienced an AE, regardless of causality or severity, was summarized.|Up to Week 4|The All-Subjects-as-Treated (ASaT) population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
2625069|NCT01918033|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2|The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms.|Baseline and Week 2|The Full Analysis Set (FAS) population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for TNSS.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2625070|NCT01917812|Secondary|Mean Daily Aerobic Activity Time|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from 3 weeks mean daily aerobic activity time at 5 weeks (end of smart text messaging intervention)||||minutes per day||Standard Deviation|Mean
2625071|NCT01917812|Secondary|Mean Daily Activity Time|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from 3 weeks mean daily activity time at 5 weeks (end of smart text messaging intervention)||||minutes per day||Standard Deviation|Mean
2625072|NCT01917812|Primary|Mean Daily Step Count|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from 3 weeks mean daily step count at 5 weeks (end of smart text messaging intervention)||||steps per day||Standard Deviation|Mean
2625073|NCT01917812|Secondary|Mean Daily Aerobic Activity Time|"Defined as the time spent walking continuously for >10 minutes without breaking for more than a minute.~Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts."|Change from baseline mean daily aerobic activity time at 3 weeks (end of unblinded digital activity tracker intervention)||||minutes per day||Standard Deviation|Mean
2625074|NCT01917812|Secondary|Mean Daily Activity Time|Note that the study occurred over two study phases after the 1-week blinded run-in. In the first 2-week phase, participants were randomized to unblinded or blinded tracking. In the second 2-week phase, the unblinded participants were randomized to receive smart texts or no texts.|Change from baseline mean daily activity time at 3 weeks (end of unblinded digital activity tracker intervention)||||minutes per day||Standard Deviation|Mean
2625092|NCT01917526|Primary|Number of Participants With Hypoxemia in Both Groups|Hypoxemia is defined as oxygen saturation < 94%. We record number of participants with hypoxemia in both groups|In PACU (1 hr after anesthesia)||||number of participants|||Number
2625076|NCT01917773|Primary|Compared Colonic Motility Index From Fasting to Post Octreotide Infusion|"Colonic motility was measured using a solid-state catheter. The catheter had 36 sensors spaced 5-cm apart for the first 15 sensors and 1-cm apart for the remaining sensors. Pressures were transmitted to a transducer and recorded on a personal computer system (Medical Measurement Systems USA, Dover, NH).~Motility index (MI) was calculated using the Medical Measurement Systems computer program. The MI represents the area under the curve of the pressure tracing for a certain period (21). The MI was calculated for each channel. The MIs from all of the channels were then averaged to give each patient 1 average MI for the particular period under study. In this study, MI was calculated for the periods of 15, 30, and 45 minutes before and after infusion of octreotide. MI is reported as millimeters of mercury (mmHg) per 15, 30, or 45 minutes."|Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide.||||mm Hg||95% Confidence Interval|Mean
2625077|NCT01917747|Secondary|Number of Weeks Between Date of Hearing Loss Diagnosis and Intervention (Aim 2)|This outcome is the timing of hearing loss intervention from the date of hearing loss diagnosis until the date of documented hearing loss intervention, assessed up to 12 months.|From the date of hearing loss diagnosis until up to one year|No data was collected because no patients were recruited into this Aim of the study. None of the study participants (N=106) were found to have hearing loss thus there were not eligible to receive hearing loss treatment and thus not eligible for aim 2.||||||
2625078|NCT01917747|Secondary|Number of Weeks Between Birth and Date of Diagnostic Audiological Testing (Aim 1)|This outcome is the timing of diagnostic audiological testing after failed newborn hearing screening from the date of randomization until the date of first documented diagnostic audiological testing, assessed up to 12 months after birth.|From date of randomization to first audiological diagnostic test up to 12 months of age||||weeks||Standard Deviation|Mean
2625079|NCT01917747|Primary|Number of Participants Who do Not Receive Hearing Intervention by Six Months of Age (Aim 2)|This outcome is the number of participants who do not follow-up for therapeutic audiological intervention after a diagnosis of infant hearing loss is made from the date of randomization to 6 months after birth.|From the date of hearing loss diagnosis up to 6 months after birth|No data was collected because no patients were recruited into this Aim of the study. None of the study participants (N=106) were found to have hearing loss thus there were not eligible to receive hearing loss treatment and thus not eligible for aim 2.||||||
2625080|NCT01917747|Primary|Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1)|This outcome is the number of participants who do not follow-up for diagnostic audiologic testing after a failed newborn hearing screening from the date of randomization to 3 months after birth.|3 months after birth||||Participants|||Count of Participants
2625081|NCT01917656|Secondary|Number of Treatment Emergent Adverse Events (TEAEs) During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.|"A serious AE was an experience that at any dose resulted in any of the following: Death, a life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, a persistent or significant disability or incapacity, congenital anomaly or birth defect, important medical events.~Mild - no or transient symptoms, no interference with the subject's daily activities Moderate - marked symptoms, moderate interference with the subject's daily activities Severe - considerable interference with the subject's daily activities, unacceptable"|Day -1 to day 29|Safety analysis set|||Events/1000 years of patient exposure|||Number
2625082|NCT01917656|Secondary|Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period.||Day -1 to day 29|Safety analysis set|||Events/1000 years of patient exposure|||Number
2625083|NCT01917656|Secondary|Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol), and no Confirmed Hypoglycaemic Episodes|Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target)|Visit 14 (4 weeks post Ramadan)|Full analysis set|||percentage (%) of subjects|||Number
2625084|NCT01917656|Secondary|Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target)|Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target)|Visit 14 (4 weeks post Ramadan)|Full analysis set|||percentage (%) of subjects|||Number
2625085|NCT01917656|Secondary|Change From Baseline to End of Ramadan in Body Weight||Baseline, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.|||kg||Standard Error|Least Squares Mean
2625086|NCT01917656|Secondary|Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c)|The level of glycosylated haemoglobin in blood was used to assess the glycaemic control of the patients during the time period described.|Baseline, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
2625087|NCT01917656|Secondary|Change From Baseline to End of Ramadan in Fasting Plasma Glucose|The changes from baseline measured postbaseline (i.e., the changes measured on visit 8 and 12) entered as the dependent variables, and visit, treatment, country, and the stratification variables were included as fixed factors and the corresponding values for the specific endpoint measured at randomisation as covariate.|Baseline, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.|||mmol/L||Standard Deviation|Mean
2625088|NCT01917656|Secondary|Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG)|The level of FPG in the blood of fasting patients was addressed to monitor glycaemic control during the period described.|Day -1, day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.|||mmol/L||Standard Deviation|Mean
2625089|NCT01917656|Secondary|Fructosamine at End of Ramadan|The fructosamine values at the end of Ramadan (visit 12) were presented|Day 29|Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis.|||umol/L||Standard Deviation|Mean
2625093|NCT01917513|Secondary|Number of Polyp and Adenoma Detection, Procedure Times and Safety (Number of Patients With Adverse Events.|The secondary outcome is a composite-each of the measured parameters will be reported as a single value for each arm|Up to 14 days (histology results)|||||||
2625101|NCT01917318|Secondary|Suicidal Behavior|The presence and severity os suicidal behavior was monitored over the course of the trial by the third section of the Columbia Suicide Severity Rating Scale (CSSRS). This sections consists of questions about 5 suicidal behaviors and non‐suicidal self injurious behavior and it can be answered yes or no. The number of participants who experienced suicidal behavior is reported.|Total course of the study. CSSRS was administered during each study visit. Suicidal ideation during lifetime and during the month prior to screening were also explored|Study was terminated due to lack of enrollment.|||participants|||Number
2625102|NCT01917318|Secondary|Intensity of Suicidal Ideation|"Intensity of Suicidal Ideation was monitored over the course of the trial by the second section of the Columbia Suicide Severity Rating Scale (CSSRS). This section is only administered if the patient answers yes to the first section. The section consists of 5 questions that refer to the most severe level of ideation endorsed in the first section of the CSSRS. The total score ranges from 2 to 25, with a higher number indicating more intense ideation and greater risk.~Only lifetime intensity of suicidal ideation was explored as the patient had no suicidal ideation from the month prior to beginning the study to the completion of the study"|Baseline|Study was terminated early due to lack of enrollment.|||score on a scale|||Number
2625103|NCT01917318|Secondary|Suicidal Ideation|The presence of suicidal ideation was monitored over the course of the trial by the first section of the Columbia Suicide Severity Rating Scale (CSSRS). This first section of the scale consists of 5 questions that can be answered yes or no. The number of participants who reported experiencing suicidal ideation is reported.|Total course of the study. CSSRS was administered during each study visit. Suicidal ideation during lifetime and during the month prior to screening were also explored|Study was terminated early due to lack of enrollment.|||participants|||Number
2625104|NCT01917318|Secondary|Wake-time After Sleep Onset (WASO)|WASO was measured by wrist actigraphy and sleep logs. Actigraphy results were downloaded at each study visit. The mean value during placebo treatment was calculated.There was only 1 value during iloperidone treatment.|Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment .|Study was terminated due to lack of enrollment. No data for this outcome measure was collected for the single participant.||||||
2625105|NCT01917318|Secondary|Sleep Latency|Sleep latency was measured by wrist actigraphy and sleep logs. Actigraphy results were downloaded at each study visit. The mean value during placebo treatment was calculated.There was only 1 value during iloperidone treatment|Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment .|Study was terminated due to lack of enrollment. No data for this outcome measure was collected for the single participant.||||||
2625106|NCT01917318|Secondary|Aggression|Aggression was measured by the Modified Overt Aggression Scale (MOAS).This assessment measures four types of aggressive behavior (verbal, aggression against property, autoaggression, and physical aggression) . Total scores on the MOAS range from 0-40, with a higher score indicating more aggressive behavior.|Randomization and 8 weeks of treatment, during both treatment periods|Study was terminated due to lack of enrollment. No data for this outcome measure was collected for the Iloperidone / Placebo arm.|||units on a scale|||Number
2625107|NCT01917318|Secondary|Number of Awakenings|Number of awakenings was measured by wrist actigraphy and sleep logs. Actigraphy results were downloaded at each study visit. The mean value during placebo treatment was calculated. There was only 1 value during iloperidone treatment.|Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment .|Study was terminated due to lack of enrollment. No data for this outcome measure was collected for the single participant.||||||
2625108|NCT01917318|Primary|Change in Clinician Administered PTSD Scale (CAPS) Part B and D|"The Clinician-Administered PTSD Scale (CAPS) is a structured interview used to diagnose and assess PTSD. Part B of CAPS evaluates symptoms of re-experiencing. Part D evaluates avoidance and numbing.~CAPS-B scores range from 0 to 40 where higher scores indicate more symptoms. A score 0 means no re-experiencing symptoms.~CAPS-D scores range form 0 to 56 and higher scores indicate more symptoms. A score 0 means no avoidance or numbing symptoms.~The primary endpoint was changes in CAPS part B and D after 8 weeks of treatment."|Randomization and at the end of each treatment period. Placebo treatment lasted 8 weeks. Iloperidone treatment lasted 2 weeks.|Study was terminated due to lack of enrollment.|||units on a scale|||Number
2625109|NCT01917214|Secondary|Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy|Number of participants with CR, PR, SD and PD responses assessed as per clinical and radiological documentation in clinical notes for different durations of treatment with Sutent were reported. CR was defined as complete resolution of all visible disease, PR was defined as partial reduction in size of visible disease, SD was defined as no change in size of visible disease, and PD was defined as an increase in visible disease.|From initiation of treatment up to 72 months|Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy. Here, “n” signifies those participants who were evaluable for this measure for specified treatment duration.|||participants|||Number
2625110|NCT01917214|Secondary|Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy|"Number of participants with CR, PR, SD and PD responses assessed as per clinical and radiological documentation in clinical notes for different Sutent doses were reported. CR was defined as complete resolution of all visible disease, PR was defined as partial reduction in size of visible disease, SD was defined as no change in size of visible disease, and PD was defined as an increase in visible disease. Here other refers to Sutent 12.5 mg."|From initiation of treatment up to 72 months|Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy. Here, “n” signifies those participants who were evaluable for this measure for specified Sutent treatment.|||participants|||Number
2625156|NCT01916304|Primary|Percentage of Participants That Do Not Need a Change of Dose|Dose change was determined by physician according to their clinical judgement.|2 months (± 2 weeks) after switch to sodium formulation.|Participants from the intent-to-treat population, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2625111|NCT01917214|Secondary|Time to Treatment Failure From Initiation of Sutent Therapy|Time to treatment failure was defined as the time from initiation of study treatment to the date of the first documentation of Progressive Disease (PD), symptomatic deterioration, death due to any cause, or discontinuation of treatment due to AE, refusal or other reason. PD was defined as an increase in visible disease.|From initiation of treatment up to 72 months|Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy. Here, “N” (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2625112|NCT01917214|Secondary|Overall Survival (OS)|Overall survival was the duration from diagnosis of disease to death. Overall survival was compared for those who had received best supportive care to those who received Sutent as first-line therapy.|From diagnosis until death (up to 72 months)|Participants diagnosed with mRCC during time period between 1 January 2006 and 31 December 2011 and received Sutent or Best Supportive Care as a first-line therapy. Here, “N” (number of participants analyzed)=participants who were evaluable for this outcome measure. “n”=participants who were evaluable for this measure for each specified treatment.|||months||95% Confidence Interval|Median
2625113|NCT01917214|Secondary|Objective Response Rate - Percentage of Participants With Objective Response From Initiation of Sutent Therapy|Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) as per clinical and radiological documentation in clinical notes. CR was defined as complete resolution of all visible disease, whereas PR was defined as partial reduction in size of visible disease.|From initiation of treatment up to 72 months|Participants diagnosed with mRCC during the time period between 1 January 2006 and 31 December 2011 and received Sutent as a first-line therapy.|||percentage of participants|||Number
2625114|NCT01917214|Primary|Progression-Free Survival (PFS) From Initiation of Sutent Therapy|PFS was defined as the time from initiation of Sutent (sunitinib malate) to first documentation of tumor progression or to death due to any cause, whichever occurred first. Time to treatment failure was used as a surrogate for PFS as PFS could not be determined due to retrospective nature of this study.|From initiation of treatment up to 72 months|Time to treatment failure (given in outcome measure 4) was used as a surrogate for PFS due to the lack of consistent regular restaging scans in clinical practice.||||||
2625115|NCT01917188|Primary|Mean Differences in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Results|"The mean differences in heart failure knowledge (from study enrollment to the 30 day study follow up) in each of the arms as assessed by the MLHFQ. Lower scores indicate improvement and a better health-related quality of life (HRQoL).~The MLHFQ is a self-administered questionnaire for patients with HF, comprising 21 items rated on six-point Likert scales, representing different degrees of impact of HF on HRQoL, from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25). The other eight items (of the total of 21) are only considered for the calculation of the total score."|30 days|Only a small number of people completed and returned the quiz.|||score on a scale||Standard Deviation|Mean
2625116|NCT01917136|Primary|Changes in RV Function|RV function as measured by cardiac MRI|6 months|Patient completed the cardiac MRI at 6 months, changes in RVEF|||percentage||Standard Error|Least Squares Mean
2625117|NCT01917006|Secondary|Change From Baseline in Geometric Mean IELT|IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the SID. The Logarithm Value of the Geometric Mean of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and SD of log-transformed geometric mean IELTs were then calculated for each treatment group. An ANCOVA Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement.|Baseline (Day 1) to Weeks 2, 4, 6, 8, and 10|The mITT population included all randomized participants who received study treatment and had post-baseline IELT data available based on the dose actually received by the participant. Number analyzed is the number of participants with available data at the given time-point.|||log(seconds)||Standard Deviation|Mean
2625118|NCT01917006|Secondary|Change From Baseline in Average IELT|IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the SID. The average of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and SD of average IELTs were then calculated for each treatment group. An ANCOVA Model with treatment as the fixed effect and baseline average mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement.|Baseline (Day 1) to Weeks 2, 4, 6, 8, 10, and 12|The mITT population included all randomized participants who received study treatment and had post-baseline IELT data available based on the dose actually received by the participants. Number analyzed is the number of participants with available data at the given time-point.|||seconds||Standard Deviation|Mean
2625119|NCT01917006|Primary|Change From Baseline in Geometric Mean Intravaginal Ejaculatory Latency Time (IELT)|IELT, the time from vaginal penetration to ejaculation, was measured by a stopwatch and was recorded in the sexual intercourse diary (SID). The Logarithm Value of the Geometric Mean of each individual participant's IELT recorded in the SID up to each time point was calculated. The mean and standard deviation (SD) of log-transformed geometric mean IELTs are then calculated for each treatment group. An Analysis of Covariance (ANCOVA) Model with treatment as the fixed effect and baseline geometric mean IELT as the covariate was used for analyses. A positive change from Baseline indicates improvement.|Baseline (Day 1) to Week 12|The modified intent-to-treat (mITT) population included all randomized participants who received study treatment and had post-baseline intravaginal ejaculatory latency time (IELT) data available based on the dose actually received by the participant. Number analyzed is the number of participants with available data at the given time-point.|||log(seconds)||Standard Deviation|Mean
2625180|NCT01915914|Secondary|Numbers of Recurrent Participants at the End of the Maintenance Phase (Week 20)|The number of participants with AD recurrent/relapse at the end of Maintenance Phase is presented. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success. Participants with treatment success is defined as participants with PSGA <=1; and the improvement >=2 compared to Baseline.|From Week 0 (or treatment success, if earlier) to Week 20|ITT Population|||Participants|||Number
2625120|NCT01916980|Secondary|Change From Baseline in the Pruritus/Itch Visual Analog Scale (VAS) Score Recorded by Participants at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12|Participants assessed the degree of their pruritus using a 100-mm visual analog scale (VAS; 0mm=No itch, 100mm=Worst imaginable itch) at Baseline and subsequent clinic visits. Pruritus/itch VAS scores could range from 0 to 100, with a higher score indicating more severe pruritus/itching. The changes from Baseline in the VAS scores for pruritus/itch at the Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for participant-assessed pruritus/itch VAS score.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2625121|NCT01916980|Secondary|Percentage of Participants With Moderate or Remarkable Improvement in the Global Improvement Rate of Pruritus/Itch Assessed by the Investigator at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12|The global improvement judgment criteria were used to assess overall improvement in pruritus/itch. The Investigator assessed the degree of severity of pruritus/itch based on 5 grades (1=Remarkably improved to 5=Aggravated) at Baseline and subsequent clinic visits. The percentages of participants who were remarkably improved (Grade 1=Pruritus/itch disappeared) or moderately improved (Grade 2=Pruritus/itch was greatly improved) at the Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed Global Improvement.|||Percentage of Participants|||Number
2625122|NCT01916980|Secondary|Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12|The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher sum score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime pruritus/itch scores at the Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit|The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed pruritus/itch score.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2625123|NCT01916980|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug is also an AE.|Up to 12 weeks|The APaT population consisted of all participants who received at least one dose of study drug.|||Percentage of Participants|||Number
2625124|NCT01916980|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug is also an AE.|Up to 14 weeks (Up to 2 weeks after last dose dose of study drug)|The All-Participants-as-Treated (APaT) population consisted of all participants who received at least one dose of study drug.|||Percentage of Participants|||Number
2625125|NCT01916980|Primary|Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Week 2|The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher sum score indicating greater severity. The change from Baseline in the sum of the daytime and nighttime pruritus/itch scores at Week 2 clinic visit was calculated.|Baseline Visit and Week 2 Visit|The Full Analysis Set (FAS) population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed pruritus/itch score.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2625126|NCT01916967|Secondary|Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2|The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses to questions about the effect of participant skin problems on life ranged from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life. Participants >=16 years of age completed the DLQI questionnaire about the condition of their skin over the previous week. The changes from Baseline in the DLQI total score at the Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for DLQI|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2625192|NCT01915771|Primary|Cmax|Maximum observed concentration of lomitapide and its metabolites, M1 & M3.|Pre dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post dose.|Only 13 subjects who had evaluable PK data in both study periods were included in the PK analysis of lomitapide. One subject was excluded from PK analysis of M1 and M3 during Period 1 due to early termination. Another subject was excluded from PK analysis of M1 and M3 during Period 2 because the subject did not complete both Periods 1 and 2.|||ng/mL||Standard Deviation|Mean
2625127|NCT01916967|Secondary|Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2|Participants assessed the severity of their rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2625128|NCT01916967|Secondary|Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2|Participants assessed the degree of their pruritus/itching using a 100-mm visual analog scale (VAS) (0 mm=No itch to 100 mm=Worst imaginable itch), with a higher score indicating more severe itching. The changes from Baseline in participant-assessed pruritus/itch at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2625129|NCT01916967|Secondary|Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2|Participants assessed the severity of their pruritus/itch during the daytime and nighttime (0=asymptomatic to 4=severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2625130|NCT01916967|Secondary|Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2|The global improvement judgment criteria were used to assess overall improvement in pruritus/itch and rash. The Investigator assessed participant global improvement according to 5 grades (Grade 1=Remarkable improvement to Grade 5=Aggravated). The number of participants with moderate or remarkable improvements was calculated. Remarkable improvement (Grade 1) was defined as both pruritus/itch and rash (erythema and wheal) disappeared, or pruritus/itch disappeared and rash (erythema and wheal) was apparently improved. Moderate improvement (Grade 2) was defined as both pruritus/itch and rash (erythema and wheal) were greatly improved.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.|||Participants|||Number
2625131|NCT01916967|Secondary|Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2|The Investigator assessed the severity of participant rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2625132|NCT01916967|Secondary|Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2|The Investigator assessed the severity of participant pruritus/itch during the daytime and nighttime (0=Asymptomatic to 4=Severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2625133|NCT01916967|Secondary|Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1|The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The changes from Baseline in the sum of the pruritus/itch and overall rash scores at the Day 3 and Week 1 clinic visits were calculated.|Baseline Visit and Day 3 Visit, Week 1 Visit|The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2625134|NCT01916967|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.|Up to 2 weeks|The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.|||Participants|||Number
2625216|NCT01914757|Secondary|Extent of Exposure|Extent of exposure is defined as the duration of treatment in days|Immediately following the first administration of study drug through Study Week 56|Safety analysis set|||Days||Standard Deviation|Mean
2625135|NCT01916967|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE.|Up to 4 weeks (Up to 2 weeks after last dose of study drug)|The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.|||Participants|||Number
2625136|NCT01916967|Primary|Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2|The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The change from Baseline in the sum of the pruritus/itch and overall rash scores at the Week 2 clinic visit was calculated.|Baseline Visit and Week 2 Visit|The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and a Week 2 assessment for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2625137|NCT01916941|Primary|Number of Standard Alcoholic Drinks Consumed Per Week (Drinks Per Week)||from 2-4 weeks and from 4-6 weeks||||drinks per week||Standard Deviation|Mean
2625138|NCT01916928|Secondary|The Accuracy of ccffDNA Compared to Genetic Information Obtained From Amniocentesis, Chorionic Villus Sampling, Fetal, or Placental Tissue.||3-4 weeks after specimen processing|||||||
2625139|NCT01916928|Primary|The Presence or Absence of Cell Free Fetal DNA in Maternal Blood in the Setting of a Failed Pregnancy.|Percentage of participants with the presence of cell free fetal DNA in maternal circulation after miscarriage of intrauterine fetal demise|During initial presentation for treatment||||percentage of participants|||Number
2625140|NCT01916824|Primary|Money Earned|"Change in amount of money earned between baseline and after 6 weeks of antidepressant treatment is determined through a summary score from a variety of decision-making tasks. Participants received between $5 and $40 per visit, depending on the outcomes of the decisions made on the computerized tasks. Variable payment ensured that the decision-making tasks were approached realistically, as opposed to using hypothetical points that do not have meaning in the real world. Greater earnings indicate better financial decision-making.~The specific tasks were:~risk task~balloon analogue risk task~temporal discounting task~ultimatum game~continuous performance task"|Baseline, Week 6|The population at each time point includes the number of participants completing the each visit.|||US Dollars||Standard Deviation|Mean
2625141|NCT01916681|Secondary|Maternal Morbidity||Enrollment through discharge||||participants|||Number
2625142|NCT01916681|Secondary|Chorioamnionitis||Enrollment through deischarge||||participants|||Number
2625143|NCT01916681|Secondary|Regional Anesthesia||During delivery||||participants|||Number
2625144|NCT01916681|Secondary|Time to Active Labor||Start of induction to active labor||||Hours||Inter-Quartile Range|Median
2625145|NCT01916681|Secondary|Mode of Delivery|Cesarean Delivery|Start of induction to delivery||||participants|||Number
2625146|NCT01916681|Primary|Severe RDS||enrollment through neonatal discharge||||participants|||Number
2625147|NCT01916681|Primary|Length of Stay|Total maternal length of stay as defined as days from the day the induction began to the day of discharge|Days between admit to hospital and discharge||||Days||Inter-Quartile Range|Median
2625148|NCT01916681|Primary|Time to Delivery|Amount of hours that pass between the start of the induction to delivery.|Hours between start of induction to delivery||||Hours||Inter-Quartile Range|Median
2625149|NCT01916655|Primary|Positive Airway Pressure Adherence|objective measurement of the amount of time PAP therapy is used at the prescribed pressure|2 month time point||||Hours||Standard Deviation|Mean
2625150|NCT01916629|Primary|Percent Lesion Clearance||90 days||||Percent Clearance||Standard Deviation|Mean
2625151|NCT01916590|Primary|Pain Scores Will be Collected for 48 Hours After ACL Reconstruction|Pain scores will be collected for 48 hours after ACL reconstruction with a patellar tendon graft or allograft and used to measure the effectiveness of the femoral catheter vs. single shot femoral nerve block|48 hours after surgery|Because of the lack of enrollment no data was collected||||||
2625152|NCT01916304|Secondary|Relative Percent Change From Baseline in Serum Thyroid Stimulating Hormone|Blood samples were collected and samples were analyzed according to the local Quality System. A negative change from Baseline indicated improvement.|Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.|Participants from the intent-to-treat population, with data available for analysis.|||percent change||Inter-Quartile Range|Median
2625153|NCT01916304|Secondary|Absolute Serum Thyroid Stimulating Hormone Values|Blood samples were collected and samples were analyzed according to the local Quality System.|Baseline, Month 2 (± 2 weeks) and Month 4 (± 4 weeks) after inclusion into study.|Participants from the intent-to-treat population, with data available for analysis.|||mIU/mL||Inter-Quartile Range|Mean
2625154|NCT01916304|Secondary|Percentage of Participants That Obtained a Thyroid Stimulating Hormone (TSH) Between 0.4-2.5 mU/L|Blood samples were collected and samples were analyzed according to the local Quality System.|Month 4 (± 4 weeks) after inclusion into study.|Participants from the intent-to-treat population, with data available for analysis.|||percentage of participants|||Number
2625155|NCT01916304|Secondary|Magnitude of the Change in Daily Dose Needed|Magnitude was determined via a change table which provides the percentage of participants that needed a change in Daily Dose (μg/day) of -25 μg, -12.5 μg, -6.25 μg, -5.35 μg, 0 μg or +12.5 μg.|2 months (± 2 weeks) after switch to sodium formulation.|Participants from the intent-to-treat population, with data available for analysis.|||percentage of participants|||Number
2625157|NCT01916226|Secondary|Mean Change From Baseline in the Combined Nasal and Ocular Reflective Total Symptom Score (rTSS = rTNSS+rTOSS) Over the Entire Treatment Period|The rTSS is the sum of the rTNSS and the rTOSS. The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the rTNSS ranges from 0 (none) to 12 (severe). Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The rTOSS assessment is comprised of the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; or 3, severe. The rTOSS ranges from 0 (none) to 9 (severe). The reflective assessment scores participants' symptoms over the previous 24 hours. The participants themselves scored nasal and ocular symptoms in an e-diary. Baseline is defined as the arithmetic average of the rTSS recorded on the morning of randomization and on each of the six preceding days.|Baseline through the entire treatment period (2 weeks)|Ocular Population. Change from Baseline was calculated as the 2-week average minus the Baseline value.n|||Scores on a scale||Standard Error|Mean
2625158|NCT01916226|Secondary|Mean Change From Baseline in the AM Pre-dose Instantaneous Total Ocular Symptom Score (iTOSS) Over the Entire Treatment Period|"The iTOSS is an eye assessment that comprises the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; 3, severe. The iTOSS ranges from 0 (none) to 9 (severe). The instantaneous assessment scores the participants' ocular symptoms at the time of the assessment, or at that instant. The participants themselves scored ocular symptoms in an e-diary once each morning prior to administering study drug. Baseline is defined as the arithmetic average of the iTOSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value."|Baseline through the entire treatment period (2 weeks)|Ocular Population|||Scores on a scale||Standard Error|Mean
2625159|NCT01916226|Secondary|Mean Change From Baseline in the AM Pre-dose Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period|The rTOSS is an eye assessment that comprises the sum of the three symptom scores for tearing/watering, itching/burning, and eye redness. Each symptom is scored on a scale of 0 to 3: 0, none; 1, mild; 2, moderate; 3, severe. The rTOSS ranges from 0 (none) to 9 (severe). The reflective assessment scores the participants' ocular symptoms over the preceding 24 hours. The participants themselves scored ocular symptoms in an e-diary. Baseline arithmetic is defined as the average of the rTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.|Baseline through the entire treatment period (2 weeks)|Ocular Population: all ITT participants with a Baseline rTOSS of 4 or greater|||Scores on a scale||Standard Error|Mean
2625160|NCT01916226|Secondary|Mean Change From Baseline in the AM Pre-dose Instantaneous Total Nasal Symptom Score (iTNSS) Over the Entire Treatment Period|"The iTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the iTNSS ranges from 0 (none) to 12 (severe). The symptoms were evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The instantaneous assessment of the TNSS scores the four nasal symptoms at the time of the assessment, or at that instant. The participants themselves scored nasal symptoms in an e-diary once each morning prior to administering study drug. Baseline is defined as the arithmetic average of the iTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days."|Baseline through the entire treatment period (2 weeks)|ITT Population. Change from Baseline was analyzed for only those participants who were available for assessment at Baseline and at Weeks 1 and 2. Change from Baseline was calculated as the 2-week average minus the Baseline value.|||Scores on a scale||Standard Error|Mean
2625161|NCT01916226|Secondary|Mean Change From Baseline in the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) Overall Score at Visit 3/Early Withdrawal.|The NRQLQ is a 16-item, validated, self-administered, disease (allergic rhinitis)-specific quality of life instrument that measures the functional problems most troublesome to participants with nocturnal allergy symptoms over a one-week interval. Each question is scored on a 7-point scale from 0 (not troubled) to 6 (extremely troubled). Items are grouped into four domains: sleep problems (4 items), sleep time problems (5 items), symptoms on waking in the morning (4 items), and practical problems (3 items). An overall score was calculated from the individual item scores. All items are weighted equally. A mean score is calculated across all items within each domain. The overall score is the mean across all items and ranges from 0 (not troubled) to 6 (extremely troubled). Higher scores reflect a lower quality of life. Change from Baseline was calculated as the 2-week average minus the Baseline value.|Baseline and Visit 3 (Study Day 14 +/- 2 days)/Early Withdrawal|ITT Population|||Scores on a scale||Standard Error|Mean
2625162|NCT01916226|Secondary|Mean Change From Baseline in the Individual AM Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion, Nasal Itching, and Sneezing Over the Entire Treatment Period|Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe).The reflective assessment scores the four nasal symptoms over the previous 24 hours. The participants themselves scored nasal symptoms in an e-diary. Baseline is defined as the arithmetic average of the individual AM reflective nasal symptom scores recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.|Baseline through the entire treatment period (2 weeks)|ITT Population. Change from Baseline was analyzed for only those participants who were available for assessment at Baseline and at Weeks 1 and 2.|||Scores on a scale||Standard Error|Mean
2625163|NCT01916226|Primary|Mean Change From Baseline (CFB) in the Individual AM Reflective Total Nasal Symptom Scores (rTNSS) Over the Entire Treatment Period|The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a scale ranging from 0 to 3; the rTNSS ranges from 0 (none) to 12 (severe). Each individual symptom was evaluated using a scale of 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The reflective assessment of the TNSS scores the four nasal symptoms over the previous 24 hours. The participants themselves scored nasal symptoms in an e-diary. Baseline is defined as the arithmetic average of the rTNSS recorded on the morning of randomization and on each of the six preceding days. A participant may have had as few as 4 days' worth of data contributing to the Baseline average. The 2-week symptom score was defined as the average of the values recorded on the day after randomization and the following 13 days. Change from Baseline was thus calculated as the 2-week average minus the Baseline value.|Baseline through the entire treatment period (2 weeks)|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication. Change from Baseline was analyzed for only those participants who were available for assessment at Baseline and at Weeks 1 and 2.|||Scores on a scale||Standard Error|Mean
2625164|NCT01916109|Primary|Pathologic Complete Response Rate (<pT0)|The absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.|1 year||||participants|||Number
2625165|NCT01915940|Secondary|Change From Baseline in IOP at Month 6|IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.|Baseline (Day 0) to Month 6|Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.|||mm Hg||Standard Error|Mean
2625166|NCT01915940|Secondary|Change From Baseline in IOP at Month 5|IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 5. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.|Baseline (Day 0) to Month 5|Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.|||mm Hg||Standard Error|Mean
2625167|NCT01915940|Secondary|Change From Baseline in IOP at Month 4|IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Month 4. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.|Baseline (Day 1) to Month 4|Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.|||mm Hg||Standard Error|Mean
2625168|NCT01915940|Primary|Change From Baseline in Intra-Ocular Pressure (IOP) at Week 12|IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 12. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.|Baseline (Day 0) to Week 12|Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.|||mm Hg||Standard Error|Mean
2625169|NCT01915940|Primary|Change From Baseline in Intra-Ocular Pressure (IOP) at Week 6|IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (T=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 6. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.|Baseline (Day 0) to Week 6|Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.|||mm Hg||Standard Error|Mean
2625170|NCT01915940|Primary|Change From Baseline in Intra-Ocular Pressure (IOP) at Week 2|IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP measurements were taken at 8 am (time (T)=0 hour), 10 am (T=2 hour), and 4 pm (T=8 hour) at Week 2. IOP readings from both eyes were averaged to compute a single IOP value for each diurnal timepoint. A negative change from Baseline indicated improvement.|Baseline (Day 0) to Week 2|Participants from the Full Analysis Set (FAS), all randomized participants who had ocular inserts placed in their eye and who had at least 1 on-treatment study visit completed, with data available for analysis at the given time-point.|||mm Hg||Standard Error|Mean
2625171|NCT01915914|Secondary|Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Maintenance Phase and Follow-up Phase|Investigator evaluated and scored the signs of cutaneous atrophy (CA), epidermal thickening/lichenification (ET/L) and abnormal pigmentation (AP) using the Visual Analogue Scale (ranging from 0 to 10, higher values represent a worse outcome) based on their subjective judgment. The change from Baseline in each sign (Cutaneous atrophy, epidermal thickening / lichenification and abnormal pigmentation) score at the end of the Maintenance Phase and Follow-up Phase and is calculated as the score at the end of the Maintenance and Follow-up Phase minus the Baseline score. Baseline is defined as VAS score for each sign obtained at Visit 4 (end of Acute Phase). Summation of VAS scores for each sign (CA, ET/L and AP) was done to calculate the Total VAS score (ranging from 0 to 30, higher values represent a worse outcome) at the Maintenance and Follow-up phase of study. The missing value was imputed using last-observation-carry-forward (LOCF) method.|Baseline, Week 20 and Week 32|ITT Population|||Scores on a scale||Standard Deviation|Mean
2625217|NCT01914757|Secondary|Immunogenicity of Benralizumab|Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.|Pre-treatment until end of follow-up|Safety analysis set|||Participants|||Number
2625172|NCT01915914|Secondary|Change From Baseline in Cutaneous Atrophy Sign Score, Epidermal Thickening /Lichenification Sign Score and Abnormal Pigmentation Score Using Visual Analogue Scale (VAS) at the End of the Acute Phase|Investigator evaluated and scored the signs of cutaneous atrophy (CA), epidermal thickening/lichenification (ET/L) and abnormal pigmentation (AP) using Visual Analogue Scale (ranging from 0 to 10, higher values represent a worse outcome) based on their subjective judgment. The change from Baseline in each signs (Cutaneous atrophy, epidermal thickening / lichenification and abnormal pigmentation) score at the end of the Acute Phase (Visit 4 [Week 0 or treatment success, depend on which time point comes first) ±2day]) and is calculated as the score at Visit 4 minus the Baseline score. Baseline is defined as the VAS score for each sign obtained before the first dose of study drug in the Acute Phase of the study (Visit 2). Summation of the VAS scores for each sign (CA, ET/L and AP) was done to calculate the Total VAS score (ranging from 0 to 30, higher values represent a worse outcome) at Visit 4 of the Acute Phase of the study.|From the start of treatment up to Visit 4 (Week 0) or treatment success (depends on which time point comes first)|Enrolled Population|||Scores on a scale||Standard Deviation|Mean
2625173|NCT01915914|Secondary|Number of Participants With Post-study Assessment of Lotion Qualities (2) Using Questionnaire|"Participants from each group completed the post-study questionnaire to rate the qualities of the lotion as compared with other skin emollients used in the past based on their experience. Each participant was asked the following Questions (Q). Q 1: It leaves my skin feeling soft and smooth; Q 2: There is nothing left on my skin; Q 3: Does not feel greasy; Q 4: Disappears into my skin quickly after I put it on; Q 5: Easy to apply; Q 6: Fragrance-free; Q 7: Spreadability; Q 8: Lack of stickiness. Participants rated the qualities of the lotion based on a 5 point scale (5= Strongly Agree, 4= Agree, 3= Neutral, 2= Disagree, 1= Strongly Disagree N/A=Does not apply to me). Participant's rating for each question were summarized."|At early withdrawal or end of the therapy visit (up to Week 32)|ITT Population|||Participants|||Number
2625174|NCT01915914|Secondary|Number of Participants With Post-study Assessment of Lotion Qualities (1) Using Questionnaire|"Participants from each group completed the post-study questionnaire to rate the qualities of the lotion as compared with other skin emollients used in the past based on their experience. Each participant was asked the following Questions (Q). Q 1: This product is easier to use than other skin emollients; Q 2: When I apply this product I am able to start my daily activities quicker than with other skin emollients; Q 3: This product leaves my skin feeling softer than other skin emollients; Q 4: I am able to apply this product to larger body surface areas than other skin emollients; Q 5: This product disappears into my skin quicker than when I apply other skin emollients. Participants rated the qualities of the lotion based on a 5 point scale (5= Strongly Agree, 4= Agree, 3= Neutral, 2= Disagree, 1= Strongly Disagree N/A=Does not apply to me). Participant's rating for each question were summarized."|At early withdrawal or end of the therapy visit (up to Week 32)|Enrolled Population|||Participants|||Number
2625175|NCT01915914|Secondary|Number of Participants With Post-study Assessment of Skin Emollients Using Questionnaire|"Participants from each group completed the post-study questionnaire to rate the skin emollients (gel, lotion, cream, ointment, solution and foam) used in the past based on their experience. Participants rated skin emollients on a 5-point scale (5= liked the best, 4= second best, 3= third best, 2= fourth best, 1= liked the least, N/A=Does not apply to me)."|At early withdrawal or end of the therapy visit (up to Week 32)|ITT Population|||Participants|||Number
2625176|NCT01915914|Secondary|Change From Baseline in QoL at the End of the Follow-up Phase|Infant's IDQOL and Children's CDLQI were used to evaluate quality of life for participants of age between 1 to 16 years. IDQOL and CDLQI questionnaires were designed for infants (below the age of 4 years) and children (age 4 to age 16) with AD, respectively. The IDQOL and CDLQI were calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. The change from Baseline in QoL score is based on each questionnaire at the end of the Follow-up Phase and is calculated as the score at the end of the Follow-up Phase minus the Baseline score. Baseline is defined as QoL scores obtained at Visit 4 (end of Acute Phase). A QOL is equal to IDQOL if the age of a participant is < 4 years and it is equal to CDLQI if the age of a participant is between 4 and 16 years.|Baseline and Week 32|ITT Population|||Scores on a scale||Standard Deviation|Mean
2625177|NCT01915914|Secondary|Change From Baseline in Quality of Life (QoL) at the End of the Maintenance Phase|Infant's Dermatitis Quality of Life Index (IDQOL) and Children's Dermatology Life Quality Index (CDLQI) were used to evaluate quality of life for participants of age between 1 to 16 years. IDQOL and CDLQI questionnaires were designed for infants (below the age of 4 years) and children (age 4 to age 16) with atopic dermatitis, respectively. The IDQOL and CDLQI were calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score in each questionnaire, the more quality of life is impaired. The change from Baseline in the QoL score is based on each questionnaire at the end of the Maintenance Phase and is calculated as the score at the end of the Maintenance Phase minus the Baseline score. Baseline is defined as QoL scores obtained at Visit 4 (end of Acute Phase). A QOL is equal to IDQOL if the age of a participant is < 4 years and it is equal to CDLQI if the age of a participant is between 4 and 16 years.|Baseline and Week 20|ITT Population|||Scores on a scale||Standard Deviation|Mean
2625178|NCT01915914|Secondary|"Number of Participants With Treatment Success During the Acute Phase"|"The number of participants with treatment success during the Acute Phase is presented. Participants with treatment success are defined as participants with PSGA <=1; and the improvement >=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to Baseline in the Acute Phase of the study."|From the start of treatment up to Visit 4 (Week 0) or treatment success (depends on which time point comes first)|Enrolled Population: all participants who were enrolled into the Acute Phase of the study.|||Participants|||Number
2625179|NCT01915914|Secondary|Numbers of Recurrent Participants at the End of the Follow-up Phase (Week 32)|The number of participants with AD recurrent/relapse at the end of the Follow-up Phase is presented. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success. Participants with treatment success is defined as participants with PSGA <=1; and the improvement >=2 compared to Baseline.|From Week 20 to Week 32|ITT Population|||Participants|||Number
2625181|NCT01915914|Secondary|Median Time to the First Relapse of AD During the Maintenance Phase and Follow-up Phase|Median time to the first relapse of AD during the Maintenance Phase and Follow-up Phase is defined as the number of days from start of the FP treatment until AD relapse during the Maintenance Phase and Follow-up Phase. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success during the Acute Phase.|From the start of treatment up to Week 32 during the Maintenance Phase and Follow-up Phase|ITT Population. Only participants avilable at the specified time point were analyzed.|||Days||95% Confidence Interval|Median
2625182|NCT01915914|Primary|Time to the First Relapse of AD During the Maintenance Phase|Time to the first relapse of AD is defined as the number of days from start of the FP treatment in Maintenance Phase until AD relapse. AD relapse is defined as participants with PSGA exacerbation score >=2 (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe) compared to PSGA score of treatment success during Acute Phase. Participants with treatment success are defined as participants with PSGA <=1; and the improvement >=2 compared to Baseline.|From the start of treatment up to Week 20 during the Maintenance Phase|ITT Population: all participants who were randomized into the Maintenance Phase. Only participants available at the specified time point were analyzed.|||Days||95% Confidence Interval|Median
2625183|NCT01915849|Primary|Area Under the Postprandial Curve (AUC) for Rate of Appearance (Ra) of Exogenous Glucose|Glucose fluxes during a mixed meal were measured using a dual glucose tracer method and non-steady state Steele equations. The rate of appearance of meal (or exogenous) glucose in the blood (also referred to as intestinal glucose absorption or Ra meal) after a mixed meal following LIK066 administration on Days 1 and 4 was the primary PD assessment in this study.The postprandial AUC was calculated using the linear trapezoidal rule. The sample collected at 7 hours after the start of the infusion was treated as the pre-meal, 0 hour measurement for the AUC0-5 hr calculation.|Day 1 and Day 4 (pre-meal, every half hour till 5 hour on Day 1 and Day 4)|The pharmacodynamic (PD) analysis set included all patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.|||(umol/kg FFM/min)*hr||Standard Deviation|Mean
2625184|NCT01915823|Other Pre-specified|Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)|Change from baseline to Visit 4 in the ITT ( intent to treat) Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) in subjects equal to or greater than 6 years old and less than12 years old compared to placebo.Scored on a 0 to 7 scale with 0 being not troubled at all and 7 being extremely troublesome. The higher the difference the better the result.|day 1 to day 15 of treatment||||units on a scale||Standard Deviation|Mean
2625185|NCT01915823|Secondary|Safety|"Subject-reported adverse experiences (incidence, type, and severity of adverse events)~Nasal Examinations~Vital signs assessments"|entire length of study (day 1 to day 22)||||occurance|||Number
2625186|NCT01915823|Primary|Primary Efficacy|change from baseline in AM+PM rTNSS (reflective total nasal symptoms score): ITT( intent to treat population)change from baseline in 12-hour reflective total nasal symptom score (rTNSS) consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary for the entire 14 day study period.The measurement scale is 0 to 24 so that the higher the number the worse the symptom.A reduction in symptom severity score is indicated by a negative value.A greater negative value suggests improvement.|15 days of treatment||||units on a scale||Standard Deviation|Mean
2625187|NCT01915771|Primary|t1/2|Apparent terminal elimination half-life|Pre dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post dose.|Only 13 subjects who had evaluable PK data in both study periods were included in the PK analysis of lomitapide. One subject was excluded from PK analysis of M1 and M3 during Period 1 due to early termination. Another subject was excluded from PK analysis of M1 and M3 during Period 2 because the subject did not complete both Periods 1 and 2.|||hr||Standard Deviation|Mean
2625188|NCT01915771|Primary|λz|Elimination rate constant estimated from individual linear regression of the terminal part of the log concentration vs time curve|Pre dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post dose.|Only 13 subjects who had evaluable PK data in both study periods were included in the PK analysis of lomitapide. One subject was excluded from PK analysis of M1 and M3 during Period 1 due to early termination. Another subject was excluded from PK analysis of M1 and M3 during Period 2 because the subject did not complete both Periods 1 and 2.|||1/hr||Standard Deviation|Mean
2625189|NCT01915771|Primary|AUC0-∞|Area under the concentration-time curve extrapolated to infinity for lomitapide and its metabolites, M1 & M3.|Pre dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post dose.|Only 13 subjects who had evaluable PK data in both study periods were included in the PK analysis of lomitapide. One subject was excluded from PK analysis of M1 and M3 during Period 1 due to early termination. Another subject was excluded from PK analysis of M1 and M3 during Period 2 because the subject did not complete both Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
2625190|NCT01915771|Primary|AUC0-t|Area under the concentration-time curve from hour 0 to the last measurable concentration of lomitapide and its metabolites, M1 & M3.|Pre dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post dose.|Only 13 subjects who had evaluable PK data in both study periods were included in the PK analysis of lomitapide. One subject was excluded from PK analysis of M1 and M3 during Period 1 due to early termination. Another subject was excluded from PK analysis of M1 and M3 during Period 2 because the subject did not complete both Periods 1 and 2.|||ng*hr/mL||Standard Deviation|Mean
2625191|NCT01915771|Primary|Tmax|Time to reach maximum plasma concentration|Pre dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post dose.|Only 13 subjects who had evaluable PK data in both study periods were included in the PK analysis of lomitapide. One subject was excluded from PK analysis of M1 and M3 during Period 1 due to early termination. Another subject was excluded from PK analysis of M1 and M3 during Period 2 because the subject did not complete both Periods 1 and 2.|||hr||Full Range|Median
2625218|NCT01914757|Secondary|Pharmacokinetics of Benralizumab|Mean PK Concentration at each visit|Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60|PK analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2625193|NCT01915732|Secondary|Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12|The assessor evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Week 12|PP Population|||Participants|||Number
2625194|NCT01915732|Secondary|Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12|The assessor evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Week 12|ITT Population|||Participants|||Number
2625195|NCT01915732|Secondary|Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12|The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones) and total lesions (the sum of ILs and NILs)at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|PP Population|||Percent change in lesions||Standard Error|Least Squares Mean
2625196|NCT01915732|Secondary|Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 12|The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones) and total lesions (the sum of ILs and NILs)at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|ITT Population|||Percent change in lesions||Standard Error|Least Squares Mean
2625197|NCT01915732|Secondary|Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12|The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|PP Population|||Lesions||Standard Error|Least Squares Mean
2625198|NCT01915732|Secondary|Absolute Change in Inflammatory Lesion Counts and Non-inflammatory Lesion Counts From Baseline to Week 12|The assessor performed a count of ILs (papules, pustules, nodules, and cysts), NILs (open and closed comedones at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Analysis of covariance (ANCOVA) model was used with terms for Baseline lesion count, treatment, and center. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|ITT Population|||Lesions||Standard Error|Least Squares Mean
2625199|NCT01915732|Primary|Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12|ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data .|Baseline (Week 0) and Week 12|PP Population|||Participants|||Number
2625200|NCT01915732|Primary|Number of Participants With an Improvement of 2 Grades in the Investigator Static Global Assessment (ISGA) Score From Baseline to Week 12|ISGA success is defined as the improvement of 2 grades or more in the participant's acne severity scale at Week 12. Acne severity of the participants' face was assessed by the assessor using the ISGA scale, ranging from 0 to 4: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than one small IL; 2=mild, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: up to many NILs and ILs, but no more than a few NLs. Missing values were imputed using the LOCF, i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|ITT Population|||Participants|||Number
2625201|NCT01915732|Primary|Absolute Change in Total Lesion Count From Baseline to Week 12|The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|Per-Protocol (PP) Population: all participants included in the ITT Population who did not have a noteworthy protocol deviation that influenced effect.|||Change in lesion count||Standard Error|Least Squares Mean
2625219|NCT01914757|Secondary|Annual Rate of Asthma Exacerbation Resulting Emergency Room Visits and Hospitalizations|Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization (adjudicated)|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Events/year||95% Confidence Interval|Least Squares Mean
2625202|NCT01915732|Primary|Absolute Change in Total Lesion Count From Baseline to Week 12|The assessor performed a count of inflammatory lesions (IL) (papules, pustules, nodules, and cysts), non-inflammatory lesions (NIL) (open and closed comedones) and total lesions (the sum of IL and NIL) at each study visit. Lesion counts were confined to the face. Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline. Parameters were estimated using analysis of covariance (ANCOVA) with treatment, center, treatment-by-centre interaction and Baseline lesion count in the model. Missing values were imputed using the last observation carried forward (LOCF), i.e., the last available observation was used to estimate subsequent missing data.|Baseline (Week 0) and Week 12|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication.|||Change in lesion count||Standard Error|Least Squares Mean
2625203|NCT01915563|Secondary|ICU Mortality||up to 3 months||||Participants|||Count of Participants
2625204|NCT01915563|Primary|Number of Patients With Extubation Failure|Development of predefined criteria of respiratory insufficiency within 48 hours after scheduled extubation|48 hours||||Participants|||Count of Participants
2625205|NCT01915173|Secondary|GERD Health-Related Quality of Life at Follow-up|The GERD Health-Related Quality of Life (GERD-HRQL) scale is a validated instrument assessing GERD-specific health-related quality of life using 10 questions, each on a 0-5 point scale. Scale range is 0-50 with higher numbers signifying worse quality of life.|Two weeks|All enrolled study participants.|||units on a scale||Standard Deviation|Mean
2625206|NCT01915173|Secondary|Number of Subjects With a 50% or Greater Decrease in GERD Symptom Severity|Average daily GERD symptom severity during the last 7 days of the study was compared to average daily GERD symptom severity at baseline using daily study diary entries. GERD symptom severity for each day was based on the sum of scores assessing the severity of daytime heartburn, nighttime heartburn, and acid reflux each on a 0-4 point scale (none, mild, moderate, severe, very severe). Higher scores signify worse symptoms. The number of subjects with a 50% or greater decrease in GERD symptom severity from baseline to end of study in each group was calculated.|Second week of the trial compared to pre-trial baseline|All enrolled study participants.|||participants|||Number
2625207|NCT01915173|Primary|Safety - Number of Participants Experiencing a Serious Adverse Event|Serious adverse events (as defined by the FDA) are events that are potentially life-threatening or result in death, hospitalization, an emergency room visit, disability or permanent damage, a congenital abnormality, require intervention to prevent permanent impairment, or seriously jeopardizes a patient's health.|2 week follow-up|All enrolled study participants.|||participants|||Number
2625208|NCT01915108|Primary|Number of Patients With Adverse Events Following LMA Removal|All patients received a predetermined Ce of remifentanil by TCI according to their group assignments from 10 minutes before the end of surgery to LMA removal. Adverse events such as coughing, airway obstruction, breath-holding, desaturation, nausea and vomiting were evaluated from the end of surgery until arrival in the post-anesthetic care unit.|from the end of surgery until arrival in the post-anesthetic care unit, an expected average of 15 minutes.||||participants|||Number
2625209|NCT01914926|Primary|Percent of Patients Reaching Target HR<100bpm Within 30 Minutes|Percent of patient who reached a HR<100bpm within 30 minutes from baseline.|30 minutes||||percentage of participants|||Number
2625210|NCT01914757|Secondary|Patient and Clinician Assessment of Response to Treatment|CGIC (clinician global impression of change), and PGIC (patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using a 7-point rating scale, ranging from 1 (Very much Improved), to 7 (Very much Worse). This endpoint was added after the second protocol amendment, thus not all patients had data to be analyzed.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Participants|||Number
2625211|NCT01914757|Secondary|Number of Participants That Utilized Health Care Resources||Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Participants|||Number
2625212|NCT01914757|Secondary|Mean Productivity Loss Due to Asthma in Classroom|WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable for patients who took classes.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS, who took classes|||percent of productivity loss||Standard Deviation|Mean
2625213|NCT01914757|Secondary|Mean Work Productivity Loss Due to Asthma|WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. This is only applicable to patients who were employed.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS, who were employed|||Percent of productivity loss||Standard Deviation|Mean
2625214|NCT01914757|Secondary|Change From Baseline to Week 56 in EQ-5D-5L VAS|EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Scores on a scale||Standard Deviation|Mean
2625215|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in AQLQ(S)+12|AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful.|Immediately following the first administration of study drug through Study Week 56|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Scores on a scale||Standard Deviation|Mean
2625222|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils <300/uL|ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils <300/uL, High-dose ICS|||Scores on a scale||Standard Deviation|Mean
2625223|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in ACQ-6 for Patients With Baseline Eosinophils >=300/uL|ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Scores on a scale||Standard Deviation|Mean
2625224|NCT01914757|Secondary|Proportion of Nights With Awakening Due to Asthma|Change from Baseline to Week 56 on Proportion of Nights with awakening due to asthma|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Proportion of nights||Standard Deviation|Mean
2625225|NCT01914757|Secondary|Home Lung Function Assessments Based on PEF|Change from Baseline to Week 56 in Home lung function (morning and evening Peak expiratory flow [PEF])|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||L/min||Standard Deviation|Mean
2625226|NCT01914757|Secondary|Change in Asthma Rescue Medication Use|Change from Baseline to Week 56 in number of Rescue medication use (puffs/day)|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Puffs per day||Standard Deviation|Mean
2625227|NCT01914757|Secondary|Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL|Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils <300/uL, High-dose ICS|||Scores on a scale||Standard Deviation|Mean
2625228|NCT01914757|Secondary|Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL|Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Scores on a scale||Standard Deviation|Mean
2625229|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL||Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils <300/uL, High-dose ICS|||Liter||Standard Deviation|Mean
2625230|NCT01914757|Secondary|Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL||Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS|||Liter||Standard Deviation|Mean
2625231|NCT01914757|Secondary|Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL|The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils <300/uL, High-dose ICS.|||Events/year||95% Confidence Interval|Least Squares Mean
2625232|NCT01914757|Primary|Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL|The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF.|Immediately following the first administration of study drug through Study Week 56.|Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS.|||Events/year||95% Confidence Interval|Least Squares Mean
2625233|NCT01914679|Other Pre-specified|fMRI Measures of Network Connectivity|Subjects will undergo a neuroimaging scan at Baseline (week 1), week 6, and week 18. The scan will measure network connectivity during stimuli.|Baseline (week 1), week 6, and week 18|||||||
2625234|NCT01914679|Other Pre-specified|Investigate Changes in Neurocognitive Functioning Using the MASQ and MCS Assessments.|The MASQ and MCS questionnaires will be administered at Baseline (week 1), week 6, week 10, week 14, week 18 and week 21.|Baseline and up to 21 weeks|||||||
2625235|NCT01914679|Other Pre-specified|Change in Network Connectivity as Measured by EEG|EEGs will be measured at the baseline, week 4, week 18 and week 21 visits.|Baseline (week 1), week 6, week 18 and week 21|||||||
2625236|NCT01914679|Primary|Change in Patient 24-hour Recall Average Pain Intensity|"The units of measure represent self-reported average pain over the last 24 hours on a 0-100 pain rating scale where 0 is no pain and 100 is the worst pain imaginable.~."|Assessed at Baseline (Week 1), Post-Sham (Week 5), Mid-Treatment (Week 10), Mid-Treatment (Week 14), Post-Treatment (Week 18)|One participant missing from analysis at Week 14/Mid-Treatment/Visit 27 due to missed visit.|||units on a scale||Standard Deviation|Mean
2625237|NCT01914666|Secondary|Number of Participants With Fall Events From Fall Questionnaire|Participants evaluated their experience with and details of falls which were recorded. Percentage = (number of participants with fall events) /(total in treatment group) * 100.|Week 53|All the enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2625238|NCT01914666|Secondary|Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) to Week 52|"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation."|Baseline, Week 53|All randomized participants who received at least 1 dose of study drug, responded no at baseline to the suicide related questionnaire and had data at post-treatment for each question.LOCF was used.|||participants|||Number
2625239|NCT01914666|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 50|BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.|||units on a scale||Standard Deviation|Mean
2625240|NCT01914666|Secondary|Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 50|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a three level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm ranging from -0.111 to 1.0, with higher scores indicating better quality of life.|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.|||units on a scale||Standard Deviation|Mean
2625241|NCT01914666|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 50|SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) score. LOCF was used.|||units on a scale||Standard Deviation|Mean
2625242|NCT01914666|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 50|RMDQ-24 is a participant completed questionnaire and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant was instructed to put a mark next to each appropriate statement. The number of statements marked was summed by the clinician for a total score. The total score ranged from 0 (no disability) to 24 (severe disability).|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) score. LOCF was used.|||units on a scale||Standard Deviation|Mean
2625243|NCT01914666|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 50|CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).|Baseline, Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) score. LOCF was used.|||units on a scale||Standard Deviation|Mean
2625244|NCT01914666|Secondary|Patient Global Impression of Improvement (PGI-Improvement) to Week 50|PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse).|Week 50|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.|||units on a scale||Standard Deviation|Mean
2625245|NCT01914666|Secondary|Change From Baseline in Brief Pain Inventory (BPI) Pain Severity Item and Interference Item to Week 50|A self-reported scale measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.|Baseline, Week 50|(FAS): All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. The last observation carried forward (LOCF) was used.|||units on a scale||Standard Deviation|Mean
2625246|NCT01914666|Primary|Number of Participants With Drug Related Adverse Events (AEs) or Any Serious AE's|A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Week 53|All the enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2625247|NCT01914510|Secondary|Levels of Certain Proteins and Gene Expression Compared to Patient Outcome Following Treatment|Association of somatic mutations in PIK3CA, ARID1A and PTEN mutation status, and ARID1A and PTEN expression assessed in archival samples and tumour biopsies with tumour response and patient outcome following treatment with ENMD 2076.|2 years|Data not collected||||||
2625248|NCT01914510|Secondary|Time to Disease Progression|Length of time until disease progression in patients treated with ENMD-2076|2 years|Data not collected.||||||
2625249|NCT01914510|Primary|Complete or Partial Response Rate|Percentage of patients with complete or partial response as per RECIST 1.1 criteria.|2 years|Of the 40 participants enrolled onto trial, 38 were deemed eligible for evaluation. 2 patients did not complete a cycle of therapy and were considered ineligible for evaluation.|||Participants|||Count of Participants
2625273|NCT01914393|Primary|Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs)|The Safety population consists of all subjects who received at least one dose of study drug in this study.|During 104 Weeks (2-years) treatment period|The Safety population consists of all subjects who received at least one dose of study drug in this study.|||Participants|||Number
2625250|NCT01914510|Primary|Six Month Progression Free Survival Rate|Progression Free Survival (PFS) is defined as the time from first day of treatment to the first observation of disease progression or death due to any cause or last follow up. PFS will be censored for patients who are alive and free of progression at time of last follow-up.|Response will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1. Progression free survival is the time from the first day of treatment to the first observation of disease progression or Death/last F/U.|Of the 40 participants enrolled, 38 were deemed eligible for evaluation. Two patients did not complete one cycle of therapy and were considered not evaluable.|||Participants|||Count of Participants
2625251|NCT01914393|Secondary|Change From Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score|Change from Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score for subjects continued from study D1050326 The ADHD-RS IV is a validated scale that measures the behaviors of children with ADHD. The ADHD-RS IV consists of 18 items reflecting current symptomatology of ADHD based on DSM-IV-TR criteria. Each item is scored from a range of 0 (no symptoms) to 3 (severe symptoms) with total scores ranging from 0 to 54. The 18 items may be grouped into two sub-scales: hyperactivity/impulsivity (even number items 2 through 18) and inattentiveness (odd number items 1 through 17), ranging from 0 to 27. A higher ADHD-RS total score and sub-scales scores are associated with greater illness severity|Open-Label Baseline, Week 28, Week 52, and Week 104|subjects continued from study D1050326|||units on a scale||Standard Deviation|Mean
2625252|NCT01914393|Secondary|Change From Baseline in Pediatric Anxiety Rating Scale (PAR) Total Score|Change from Baseline in PAR Total Score for subjects continued from study D1050326 The PARS is a clinician-rated instrument for assessing over time the severity of anxiety symptoms associated with common DSM-IV anxiety disorders in children ages 6 17 years. The PARS is administered separately to the subject and to the caregiver. The instrument has 2 sections. The first section includes a 50-item symptom checklist, which the clinician rates as present or absent during the past week. The second section is comprised of 7 severity impairment items reflecting the severity/impairment of all symptoms endorsed in Section 1 of the PARS (during the past week). Each question is answered on a 0-5 Likert scale (0 for none, and 1-5 for minimal to extreme) with alternative responses of 8=Not Applicable and 9=Does Not Know. Scores of 8 or 9 are not counted in the summation as per the PARS instructions. The PARS total score over all 7 questions ranges in value from 0 to 35.A higher PARS total score|Open-Label Baseline, Week 28, Week 52, and Week 104|for subjects continued from study D1050326|||units on a scale||Standard Deviation|Mean
2625253|NCT01914393|Secondary|Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score|"Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score for subjects continued from study D1050326~The Pediatric Q-LES-Q is a 15-item self-report measure of the degree of enjoyment and satisfaction in various areas of daily living, based on the content of the Short From of the Q-LES-Q. Each item is rated on a 5-point scale, ranging from 1 (very poor) to 5 (very good). The first 14 items are the same as the General Activities section of the regular Q-LES-Q form and are used to compute the raw score. The PQ-LES-Q-SF percentage maximum possible score is calculated as follows:~% Max = 100 × (Raw Score - Minimum Score) / (Maximum Score - Minimum Score), where the Minimum Score equals 14 and the Maximum Score equals 70, and the % maximum possible score can range from 0% to 100%. Higher scores indicate better quality of life."|Open-Label Baseline, Week 28, Week 52, and Week 104|for subjects continued from study D1050326|||score||Standard Deviation|Mean
2625254|NCT01914393|Secondary|Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score|"Change from Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score for subjects continued from study D1050326 The Children's Global Assessment Scale (CGAS) is a numeric scale (1 through 100) used by mental health clinicians to rate the general functioning of children under the age of 18, where 1 represents the most impaired functioning and 100, superior functioning. Each decile (e.g., 1-10, 11-20) has a descriptive header (e.g., Moderate impairment in functioning in most domains) and examples of behaviors and types of environmental accommodations that might be seen at that level of functioning. Scores above 70 on the CGAS indicate functioning within the range of typically developing children of the same age as the child being rated while scores below 60 indicate a definite clinical case"|Open-Label Baseline, Week 28, Week 52, and Week 104|for subjects continued from study D1050326|||units on a scale||Standard Deviation|Mean
2625255|NCT01914393|Secondary|Change From Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score|Change from Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score for subjects continued from study D1050326 The CGI-BP-S is a three-question clinician-rated assessment of the subject's current illness state (depression, mania, and overall) using a 7-point scale (1(normal, not ill) to 7 (very severely ill)) for each question, where a higher score is associated with greater illness severity.|Open-Label Baseline, Week 28, Week 52, and Week 104|for subjects continued from study D1050326|||units on a scale||Standard Deviation|Mean
2625256|NCT01914393|Secondary|Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score|Change from Baseline in CDRS-R Total Score for subjects continued from study D1050326 CDRS-R is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 17 years. It contains 17 ordinally-scaled items that evaluate the presence and severity of symptoms commonly associated with depression in childhood. The CDRS-R is administered separately to the patient and to the caregiver; among 17 items, 14 items are based on separate interviews with child and parent, 3 items are based solely on the rater's observation of child (ie, no questions).The 14 items are rated on a 1 (no psychopathology) to 7 (most psychopathology) scale, where a rating of 3 represents mild psychopathology. The 3 items (sleep disturbance, appetite disturbance, listless speech) are rated on a 1 (no pathology) to 5 (most pathology) scale. The CDRS-R total score ranges from 17-113. In general, higher values of CDRS-R total score represent greater severity of illness|Open-Label Baseline, Week 28, Week 52, and Week 104|for subjects continued from study D1050326|||units on a scale||Standard Deviation|Mean
2625274|NCT01914159|Secondary|Vision-related Quality of Life|"National Eye Institute Visual Function Questionaire 25-item version (NEI VFQ-25)~0 to 100 scale, where 100 represents the best possible score and 0 represents the worst~Reference: Mangione CM et al. Arch Ophthalmol 2001 Jul;119(7):1050-8."|12 months||||NEI VFQ-25 score||Standard Deviation|Mean
2625275|NCT01914159|Secondary|Retinal Morphology|Spectral-domain optical coherence tomography (SD-OCT) central retinal thickness|12 months||||µm||Standard Deviation|Mean
2625257|NCT01914393|Secondary|Change From Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score|"Change from Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score for subjects continued from study D1050325 The CGSQ is comprised of total 21 items. Each item is rated on a 5-point Likert-type scale (1 (not at all a problem) to 5 (very much a problem)) and is grouped into three subscales: objective strain, subjective externalized strain, and subjective internalized strain. The 3 subscale scores are calculated as the averages of the corresponding individual items, which range in severity from 1 to 5.~Higher scores on each of these subscale scales indicate greater strain. A global strain score is calculated by summing the three subscales (i.e., objective strain, subjective externalized strain, and subjective internalized strain) to provide an indication of the total impact of the special demands on the family. Global strain scores range from 3 to 15. As with the individual subscales, higher scores indicate greater strain"|Open-Label Baseline, Week 28, Week 52, and Week 104||||score||Standard Deviation|Mean
2625258|NCT01914393|Secondary|Change From Baseline in Children's Yale-Brown Obsessive Compulsive Score (CY-BOCS)|"Change from Baseline in CY-BOCS for subjects continued from study D1050325 CY-BOCS used in the study is a modification of the Yale-Brown Obsessive Compulsive Scale and contains total 7 items for compulsion. Obsessions section was removed as it is difficult to obtain valid information given typical language/cognitive delays in the population. Each item of the compulsive scale ranges from 0 to 4. At this time, item 1b (compulsion-free interval) and item 6 (peculiarity of the behavior) are not being used in the scoring. Item 7 is a rating for reliability, ranging from 0 (excellent) to 3 (poor). It reflects the interview's judgment regarding the confidence in the data collected hence it is not counted in the CY-BOCS total score. The CY-BOCS compulsion total score is the sums of item 1-5. As a result, the CY-BOCS compulsion total score may range from 0 to 20. In general, higher values of CY-BOCS scores represent greater severity of illness"|Open-Label Baseline, Week 28, Week 52, and Week 104||||units on a scale||Standard Deviation|Mean
2625259|NCT01914393|Secondary|Change From Baseline in Clinical Global Impression (CGI) - Severity Score|Change from Baseline in Clinical Global Impression (CGI) - Severity Score for subjects continued from study D1050325 The CGI-S is a single value, clinician-rated assessment of illness severity, and 7-point scale with range from 1='Normal, not at all ill' to 7='Among the most extremely ill patients'. A higher score is associated with greater illness severity|Open-Label Baseline, Week 28, Week 52, and Week 104||||units on a scale||Standard Deviation|Mean
2625260|NCT01914393|Secondary|Change From Baseline in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score|"Change from Baseline in ABC Inappropriate Speech Subscale Score for subjects continued from study D1050325 The ABC contains 58 items resolve into five subscales: (1) irritability and agitation (15 items), (2) lethargy and social withdrawal (16 items), (3) stereotypic behavior (7 items), (4) hyperactivity and noncompliance (16 items), and (5) inappropriate speech (4 items). Each item is rated for severity on a 4-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree).~Inappropriate speech Subscale Score is calculated as summing of 9, 22, 33, and 46 items. ABC inappropriate speech Subscale Score ranges from 0 to 12.~In general, higher values of ABC subscale scores represent greater severity of illness. If one or more items are missing, no imputation was performed and the scores of the subscales that include these items was left missing"|Open-Label Baseline, Week 28, Week 52, and Week 104||||score||Standard Deviation|Mean
2625261|NCT01914393|Secondary|Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity and Noncompliance Subscale Score|"Change from Baseline in ABC Hyperactivity and Noncompliance Subscale Score for subjects continued from study D1050325 The ABC contains 58 items resolve into five subscales: (1) irritability and agitation (15 items), (2) lethargy and social withdrawal (16 items), (3) stereotypic behavior (7 items), (4) hyperactivity and noncompliance (16 items), and (5) inappropriate speech (4 items). Each item is rated for severity on a 4-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree).~Hyperactivity and noncompliance Subscale Score is calculated as summing of 1, 7, 13, 15, 18, 21, 24, 28, 31, 38, 39, 44, 48, 51, 54, and 56 items. ABC hyperactivity and noncompliance Subscale Score ranges from 0 to 48.~In general, higher values of ABC subscale scores represent greater severity of illness. If one or more items are missing, no imputation was performed and the scores of the subscales that include these items was left missing"|Open-Label Baseline, Week 28, Week 52, and Week 104||||score||Standard Deviation|Mean
2625262|NCT01914393|Secondary|Change From Baseline in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score|"Change from Baseline in ABC Stereotypic Behavior Subscale Score for subjects continued from study D1050325. The ABC contains 58 items resolve into five subscales: (1) irritability and agitation (15 items), (2) lethargy and social withdrawal (16 items), (3) stereotypic behavior (7 items), (4) hyperactivity and noncompliance (16 items), and (5) inappropriate speech (4 items). Stereotypic behavior Subscale Score is calculated as summing of 6, 11, 17, 27, 35, 45, and 49 items . ABC Stereotypic behavior Subscale Score ranges from 0 to 21. Each item is rated for severity on a 4-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree). To score the ABC, the individual items for each subscale are simply summed to their respective totals. It is inappropriate to compute a total aberrant score, based on a summation of all 58 items, as the subscales are largely independent. In general, higher values of ABC subscale scores represent greater severity"|Open-Label Baseline, Week 28, Week 52, and Week 104||||score||Standard Deviation|Mean
2625263|NCT01914393|Secondary|Change From Baseline in Aberrant Behavior Checklist (ABC) Lethargy and Social Withdrawal Subscale Score|"Change from Baseline in ABC Lethargy and Social Withdrawal Subscale Score for subjects continued from study D1050325 The ABC contains 58 items resolve into five subscales: (1) irritability and agitation (15 items), (2) lethargy and social withdrawal (16 items), (3) stereotypic behavior (7 items), (4) hyperactivity and noncompliance (16 items), and (5) inappropriate speech (4 items). Each item is rated for severity on a 4-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree).~Lethargy and Social Withdrawal Subscale Score is calculated as summing of items 3, 5, 12, 16, 20, 23, 26, 30, 32, 37, 40, 42, 43, 53, 55, and 58. ABC Lethargy and Social Withdrawal Subscale Score ranges from 0 to 48.~In general, higher values of ABC subscale scores represent greater severity of illness. If one or more items are missing, no imputation was performed and the scores of the subscales that include these items was left missing"|Open-Label Baseline, Week 28, Week 52, and Week 104||||score||Standard Deviation|Median
2625276|NCT01914159|Primary|Best-corrected Visual Acuity|Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol|12 months||||ETDRS letters||Standard Deviation|Mean
2625264|NCT01914393|Secondary|Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score|"Change from Baseline in ABC Irritability Subscale Score for subjects continued from study D1050325 The Aberrant Behavior Checklist (ABC) contains 58 items resolve into five subscales: (1) irritability and agitation (15 items), (2) lethargy and social withdrawal (16 items), (3) stereotypic behavior (7 items), (4) hyperactivity and noncompliance (16 items), and (5) inappropriate speech (4 items). Each item is rated for severity on a 4-point Likert scale ranging from 0 (not at all a problem) to 3 (the problem is severe in degree).~Irritability Subscale Score is calculated as summing of items 2, 4, 8, 10, 14, 19, 25, 29, 34, 36, 41, 47, 50, 52, and 57; as a result, ABC irritability subscale score ranges from 0 to 45.~In general, higher values of ABC subscale scores represent greater severity of illness. If one or more items are missing, no imputation was performed and the scores of the subscales that include these items was left missing"|Open-Label Baseline, Week 28, Week 52, and Week 104||||units on a scale||Standard Deviation|Mean
2625265|NCT01914393|Secondary|Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score|"Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score for subjects continued from study D1050301~The Pediatric Q-LES-Q is a 15-item self-report measure of the degree of enjoyment and satisfaction in various areas of daily living, based on the content of the Short From of the Q-LES-Q. Each item is rated on a 5-point scale, ranging from 1 (very poor) to 5 (very good). The first 14 items are the same as the General Activities section of the regular Q-LES-Q form and are used to compute the raw score. The PQ-LES-Q-SF percentage maximum possible score is calculated as follows:~% Max = 100 × (Raw Score - Minimum Score) / (Maximum Score - Minimum Score), where the Minimum Score equals 14 and the Maximum Score equals 70, and the % maximum possible score can range from 0% to 100%. Higher scores indicate better quality of life."|Open-Label Baseline, Week 28, Week 52, and Week 104||||percent of score||Standard Deviation|Mean
2625266|NCT01914393|Secondary|Change From Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score|"Change from Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score for subjects continued from study D1050301 The Children's Global Assessment Scale (CGAS) is a numeric scale (1 through 100) used by mental health clinicians to rate the general functioning of children under the age of 18, where 1 represents the most impaired functioning and 100, superior functioning. Each decile (e.g., 1-10, 11-20) has a descriptive header (e.g., Moderate impairment in functioning in most domains) and examples of behaviors and types of environmental accommodations that might be seen at that level of functioning. Scores above 70 on the CGAS indicate functioning within the range of typically developing children of the same age as the child being rated while scores below 60 indicate a definite clinical case"|Open-Label Baseline, Week 28, Week 52, and Week 104||||units on a scale||Standard Deviation|Mean
2625267|NCT01914393|Secondary|Change From Baseline in the Clinical Global Impression -Severity Score|Change from Baseline in the Clinical Global Impression -Severity Score for subjects continued from study D1050301 The CGI-S is a single value, clinician-rated assessment of illness severity, and 7-point scale with range from 1='Normal, not at all ill' to 7='Among the most extremely ill patients'. A higher score is associated with greater illness severity|Open-Label Baseline, Week 28, Week 52, and Week 104|for subjects continued from study D1050301|||units on a scale||Standard Deviation|Mean
2625268|NCT01914393|Secondary|Change From Baseline in PANSS Excitability Subscale Score|Change from Baseline in PANSS Excitability Subscale Score for subjects continued from study D1050301 Subscale of Excitability consists of the following four items from the PANSS: excitement, hostility, uncooperativeness, and poor impulse control. The sum of the four items ranges from 4 to 28 Higher values of PANSS sub-scale scores represent greater severity of illness.|Open-Label Baseline, Week 28, Week 52, and Week 104|for subjects continued from study D1050301|||units on a scale||Standard Deviation|Mean
2625269|NCT01914393|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Score|Change from Baseline in PANSS General Psychopathology Subscale Score for subjects continued from study D1050301 The General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation; General psychopathology subscale (range 16-112) is calculated as sum of Items G1 to G16 in the general psychopathology subscale Higher values of PANSS sub-scale scores represent greater severity of illness.|Open-Label Baseline, Week 28, Week 52, and Week 104|for subjects continued from study D1050301|||units on a scale||Standard Deviation|Mean
2625270|NCT01914393|Secondary|Change From Baseline in PANSS Negative Subscale Score|Change from Baseline in PANSS Negative Subscale Score for subjects continued from study D1050301 The Negative scale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; Negative subscale (range 7-49) is calculated as sum of Items N1 to N7 in the negative subscale Higher values of PANSS sub-scale scores represent greater severity of illness.|Open-Label Baseline, Week 28, Week 52, and Week 104||||units on a scale||Standard Deviation|Mean
2625271|NCT01914393|Secondary|Change From Baseline in PANSS Positive Subscale Score|Change from Baseline in PANSS Positive Subscale Score for subjects continued from study D1050301 The Positive scale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness /persecution, and hostility; Positive subscale (range 7-49) is calculated as sum of Items P1 to P7 in the positive subscale Higher values of PANSS sub-scale scores represent greater severity|Open-Label Baseline, Week 28, Week 52, and Week 104||||units on a scale||Standard Deviation|Mean
2625272|NCT01914393|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score|"Change from Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score for subjects continued from study D1050301.~PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210 Higher values of PANSS total score represents greater severity of illness."|Open-Label Baseline, Week 28, Week 52, and Week 104||||units on a scale||Standard Deviation|Mean
2625277|NCT01914003|Primary|Prevalence of CSID Genetic Variants|Prevalence of CSID genetic variants in subjects 18 years of age or younger with a primary symptom of chronic idiopathic diarrhea or chronic abdominal pain without constipation.|1 year||||Participants|||Number
2625279|NCT01913795|Primary|Asthma Symptoms|number of days of wheezing/cough|over a two week period at Baseline and Months 3, 6, 9 and 12|The number of participants analyzed here excludes participants for whom follow-up for health outcomes was incomplete.|||Days||Full Range|Mean
2625280|NCT01913600|Secondary|Dual Antiplatelet Therapy (DAPT) Compliance|Protocol defined DAPT, Aspirin and Clopidogrel or Ticlopidine, at 30 days, 180 day and 360 days.|30 days, 6 months, 12 months|At the time of the 12 month follow up there were 52 subjects with evaluable data|||Participants|||Count of Participants
2625281|NCT01913600|Secondary|Clinical Endpoint: Bleeding Complications in General|Bleeding complications in general including the GUSTO classification of Severe, Moderate & Mild will be collected. The GUSTO scale defines clinical events that stratify bleeding episodes into mild, moderate or severe.|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
2625282|NCT01913600|Secondary|Clinical Endpoint: Stroke|Defined as sudden onset of vertigo, numbness, dysphasia, weakness, visual field defects, dysarthria or other focal neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persists more than 24 hours.|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
2625283|NCT01913600|Secondary|Clinical Endpoint: Stent Thrombosis|All stent thrombosis data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions|Early Thrombosis (<=30 days), Late Thrombosis (31-360 days)|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
2625284|NCT01913600|Secondary|Clinical Endpoint: Target Vessel Revascularization (TVR)|Repeat PCI or CABG of the target vessel.|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
2625285|NCT01913600|Secondary|Clinical Endpoint: Target Lesion Revascularization (TLR)|Repeat Percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG) to the target lesion.|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
2625286|NCT01913600|Secondary|Clinical Endpoint: Myocardial Infarction (MI)|All myocardial infarction data will be reported per Medtronic historical protocol definitions and according the Academic Research Consortium (ARC) definitions.|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
2625287|NCT01913600|Secondary|Clinical Endpoint: Death|All deaths including cardiac death, vasular death and non-cardiovascular death|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
2625288|NCT01913600|Secondary|Composite Endpoint: Target Vessel MI|Target-vessel MI is defined as a MI that occurs in a territory that cannot be clearly attributed to a vessel other than the target vessel.|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
2625289|NCT01913600|Secondary|Composite Endpoint: Cardiac Death and Target Vessel MI|Combined rate of cardiac death and target vessel MI post-procedure|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
2625290|NCT01913600|Secondary|Composite Endpoint: Target Vessel Failure (TVF),|The composite endpoint comprised of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
2625291|NCT01913600|Secondary|Composite Endpoint: Target Lesion Failure (TLF)|Defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
2625292|NCT01913600|Secondary|Composite Endpoint: Major Adverse Cardiac Events (MACE)|Defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods.|30 days, 6 months, 12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
2625293|NCT01913600|Primary|Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)|The combined clinical outcome of (all cause) mortality, MI or any revascularization|12 months|2 subjects did not complete the 12 month follow up|||Participants|||Count of Participants
2625294|NCT01913535|Secondary|Number of Participants With Clinically Significant Abnormal Labs|Total number of participants with clinically significant abnormal labs|72 hours after treatment initiation|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria.|||Participants|||Count of Participants
2625295|NCT01913535|Secondary|Number of Participants With Clinically Significant Abnormal ECG|Number of Participants with clinically significant abnormal electrocardiogram (ECG)|72 hours after treatment initiation|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria.|||Participants|||Count of Participants
2625303|NCT01913535|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS)|"The 10-item Montgomery-Asberg Depression Rating Scale (MADRS), which measures depression severity (in past 3 days), was completed by clinicians using an MGH structured interview. Each item is measured on a scale from 0 to 6, and the items are summed to find the total score. The total minimum score is 0 units on a scale and the total maximum score is 60 units on a scale, where higher scores indicate more severe depression.~To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours and 20 days after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria. The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.|||units on a scale||Full Range|Median
2625296|NCT01913535|Secondary|Change in the Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior. It is a clinical interview providing a summary of both ideation and behavior that can be administered during any evaluation or risk assessment to identify the level and type of suicidality present. The C-SSRS will be performed to assess suicidal ideation and behavior. It contains a 5-item rating scale for suicidal ideation and a 7-item rating scale for suicidal behavior. Higher total scores indicate higher severity. Each item is coded 1=yes, 0=no, so a total score of 0 on each scale means that a no response was entered for each of the 5 suicidal ideation and for each of the 7 suicidal behavior questions, i.e., 0=lowest severity score. Total suicidal ideation score ranges from 0 (least severe) to 5 (most severe). Total suicidal behavior score ranges from 0 (least severe) to 7 (most severe).|Baseline and 72 hours after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria. 1 CERC-501 pt and 3 placebo pts are missing data on 72-hr change values.|||units on a scale||Full Range|Median
2625297|NCT01913535|Secondary|Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction With Participation in Social Roles and Discretionary Activities|"These are two well-validated 7-item self-rating scales that measure social health. A higher score represents higher satisfaction on each scale. The scales are rated based on the past 24 hours. Each item is rated 1-5 (1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much). Each 7-item subscale score is the sum of each of the 7 items and ranges from 7-35.~To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours and 20 days after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria.The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.|||units on a scale||Full Range|Median
2625298|NCT01913535|Secondary|Change in Positive Affect Scale (PAS)|"This is a validated, self-rated measure of positive affect uses 5-point scales (1 = very slightly/not at all to 5 = extremely). Higher scores represent higher levels of positive affect. The scale is rated based on the past 24 hours. The total score is the sum of 10 items, for a range of 10-50.~To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours and 20 days after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hrs, placebo non-responder data is included from phase 2 and is pooled with phase 1. All phase 1 placebo participants were non-responders based on HAM-D-6 and MADRS criteria.The 20-day analyses only use drug-drug (either dose) and placebo-placebo arms. 1 pt missing PAS data.|||units on a scale||Full Range|Median
2625299|NCT01913535|Secondary|Change in Perceived Stress Scale (PSS)|"This is a 10-item, validated, self-rated measure of perceived stress, that is of the degree to which the subjects perceives things to be stressful and overwhelming. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. This scale is rated based on the past 24 hours.~To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours and 20 days after treatment initiation|In the sequential parallel comparison design (SPCD) analyses through 72 hrs, placebo non-responders are included from phase 2 and are pooled with phase 1. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria. 2 pts missing 72-hr PSS values. The 20-day analyses only use drug-drug and placebo-placebo arms.|||units on a scale||Full Range|Median
2625300|NCT01913535|Secondary|Change in Symptoms of Depression Questionnaire (SDQ)|"This validated self-rating instrument has 44 items on a scale of 1-6, measuring multiple depressive symptom domains. Each item is rated based on a subject's perception of what is normal for the individual (score = 2), what is better than normal (score = 1), and what is worse than normal (scores = 3-6). This scale is rated based on the past 24 hours. A total score is calculated by summing the 44 item scores, for a range of 0-264.~To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours and 20 days after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria. The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.|||units on a scale||Full Range|Median
2625301|NCT01913535|Secondary|Clinical Global Impression-Improvement (CGI-I)|The CGI-I scale was administered by clinicians to measure improvement in depressive severity (CGI-I). Each item is rated on a seven-point scale (1=very much improved to 7=very much worse), so a higher total score indicates less improvement in depressive severity. Improvement is assessed based on the last 24 hours.|72 hours and 20 days after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria.The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.|||units on a scale||Full Range|Median
2625302|NCT01913535|Secondary|Change in Clinical Global Impression -Severity (CGI-S)|"The CGI-S scale was administered by clinicians to measure depressive severity (CGI-S). Each item is rated on a seven-point scale (1=normal to 7=among the most severe), so a higher total score indicates greater depressive severity. Severity is assessed based on the last 24 hours.~To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours and 20 days after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 and MADRS criteria. The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms.|||units on a scale||Full Range|Median
2625304|NCT01913535|Secondary|Number of Participants With Response on Hamilton Rating Scale for Depression - 6 Items (HAM-D-6)|"Compare response rates at 72 hours for of patients treated with either dose (10 mg/day or 20 mg/day) of CERC-501 to those assigned to placebo therapy, using the Sequential Parallel Comparison Design (SPCD), with response defined as a 50% or greater reduction from baseline to Day 3 on the HAM-D-6 total score).~To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline.~The HAM-D-6 instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. Scale items are assessed based on symptoms within the past 24 hours. A higher score indicates more depression symptoms."|72 hours after treatment initiation|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria.|||Participants|||Count of Participants
2625305|NCT01913535|Secondary|Change in Hamilton Rating Scale for Depression - 6 Items (HAM-D-6), Day 20|"This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. Scale items are assessed based on symptoms within the past 24 hours. A higher score indicates more depression symptoms. Total scores range from 0 (normal) to 22 (severe).~To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 20 days after initiating treatment|The 20-day follow-up analyses only use drug-drug (either dose) and placebo-placebo arms. 2 participants were in low dose drug-drug arm, 2 participants were in high dose drug-drug arm, and 1 participant was in the placebo-placebo arm. One drug-drug pt missing day 20 data.|||units on a scale||Full Range|Median
2625306|NCT01913535|Primary|Change in Hamilton Rating Scale for Depression - 6 Items (HAM-D-6)|"This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. Scale items are assessed based on symptoms within the past 24 hours. A higher score indicates more depression symptoms. Total scores range from 0 (normal) to 22 (severe).~To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, but we estimated the average during the screening period as the true baseline."|Baseline and 72 hours after initiating treatment|In the sequential parallel comparison design (SPCD) analyses through 72 hours, placebo non-responder data is included from phase 2 and is pooled with phase 1 data. All placebo participants from phase 1 were non-responders based on HAM-D-6 reduction and MADRS criteria.|||units on a scale||Full Range|Median
2625307|NCT01913483|Secondary|Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30|"Outcome assessments at Day 30 include NACE, Major Adverse Clinical Events (MACE=death, MI, stroke/TIA, amputation, or URV), and bleeding defined as BARC ≥2, as adjudicated by the CEC.~In addition to Type 3(a-c), 4, and 5, BARC ≥2 also includes Type 2 bleeding, which is any overt, actionable sign of hemorrhage (more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for Type 3, 4, or 5, but does meet at least one of the following criteria of: requiring nonsurgical, medical intervention by a health-care professional; leading to hospitalization or increased level of care; prompting evaluation."|Study drug initiation (Day 1) up to 30 days|mITT Population: Participants who were randomized into the trial, received at least one dose of study drug, and underwent the index PEI procedure.|||participants|||Number
2625308|NCT01913483|Secondary|Participants With Myocardial Infarction (MI), Stroke/Transient Ischemic Attack (TIA), Unplanned Repeat Revascularization (URV), Death, and Minor Bleeding Up to 48 h Post Study Drug Administration|"Outcome assessments at 48 h post study drug initiation include bleeding events defined as BARC Type 2 or greater (BARC ≥2), bleeding events defined as thrombolysis in myocardial infarction (TIMI) major and TIMI minor, and net adverse clinical events (NACE) as adjudicated by the CEC (NACE=death, MI, stroke/TIA, amputations, URV, or bleeding events defined as BARC ≥3).~In addition to Type 3(a-c), 4, and 5, BARC ≥2 also includes Type 2 bleeding, which is any overt, actionable sign of hemorrhage (more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for Type 3, 4, or 5, but does meet at least one of the following criteria of: requiring nonsurgical, medical intervention by a health-care professional; leading to hospitalization or increased level of care; prompting evaluation."|Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first|mITT Population: Participants who were randomized into the trial, received at least one dose of study drug, and underwent the index PEI procedure.|||participants|||Number
2625309|NCT01913483|Primary|Participants With Bleeding Academic Research Consortium Type 3 or Greater (BARC ≥3) Events Up to 48 h or at Hospital Discharge, As Adjudicated by the Independent Clinical Events Committee (CEC)|"BARC ≥3 includes:~Type 3a-3c: clinical, laboratory, and/or imaging evidence of bleeding, which includes any transfusion with overt bleeding, bleeds that result in surgical intervention or administration of IV vasoactive drugs, overt bleeds with a hemoglobin drop greater than or equal to 3 grams (g)/deciliters (dL) to greater than or equal to 5 g/dL, cardiac tamponade caused by bleeding, intracranial hemorrhage, and intraocular bleeds that compromise vision.~Type 4: (Coronary Artery Bypass Grafting-related Bleeding) includes perioperative intracranial bleeding within 48 h, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 U of whole blood or packed red blood cells within a 48-h period; and chest tube output ≥2 liters within a 24-h period.~Type 5: fatal bleeding that directly results in death that is either clinically suspicious or is confirmed as the cause of death."|Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first|mITT Population: Participants who were randomized into the trial, received at least one dose of study drug, and underwent the index PEI procedure.|||percentage of participants|||Number
2625356|NCT01913353|Secondary|Intensity of Any Serious Adverse Event (SAE)|Presentation of SAEs by intensity|Within 38 weeks for Group 1 and 30 weeks for Group 2|Full Analysis Set|||participants|||Number
2625357|NCT01913353|Secondary|Relationship to Vaccine of Any Serious Adverse Event (SAE)|Presentation of SAEs by relationship to study vaccine|Within 38 weeks for Group 1 and 30 weeks for Group 2|Full Analysis Set|||Events|||Number
2625310|NCT01913470|Other Pre-specified|Change in Aspartate Aminotransferase (AST) From Baseline to End of Treatment|The normal range for AST in children is 0 - 60 IU/L. AST can respond rapidly to treatment so decreases between Baseline and subsequent measurements indicate positive effects of treatment.|Baseline, Week 8, Week 14, and Week 22|In this blinded, crossover treatment, study participants received losartan or a placebo for 8 weeks, then completed a 6 week washout period before crossing over to the other treatment for 8 weeks. The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment.|||IU/L||Standard Deviation|Mean
2625311|NCT01913470|Secondary|Changes in Plasminogen Activator Inhibitor-1 (PAI-1) Concentrations Between Baseline and End of Treatment|PAI-1 is an acute-phase protein that is associated with both injury and inflammation, and has been found to be elevated in adolescents with significant hepatic steatosis. The reference range for PAI-1 in fasting adults is 3-72 ng/mL|Baseline, Week 8, Week 14, Week 22|The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment. One additional participant is missing PAI-1 data from the placebo phase of the study.|||ng/mL||Standard Deviation|Mean
2625312|NCT01913470|Secondary|Changes in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR) Between Baseline and End of Treatment (8 Weeks of Treatment)|Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR) is an equation which indicates the degree of insulin resistance, where higher scores equate to greater insulin resistance. HOMA-IR is calculated as fasting glucose (mg/dl) × insulin (mU/L)/405. A HOMA-IR value >2.0 in prepubertal children and >2.6 in pubertal children, may be considered a warning sign for pediatricians to further investigate insulin resistance.|Baseline (Week 0 and 14), End of Treatment (Week 8 and 22)|The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment. An additional participant is missing HOMA-IR data from the placebo phase of the study.|||units on a scale||Standard Deviation|Mean
2625313|NCT01913470|Secondary|Change in Fatty Acid Levels From Baseline to End of Treatment (8 Weeks of Treatment)|In human studies, losartan has been shown to decrease serum free fatty acids, thus any decrease in this measurement indicates a positive response to losartan.|Baseline (Week 0 and 14), End of Treatment (Week 8 and 22)|The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment. One participant is missing the endpoint measurement for free fatty acid levels, following the 8 week losartan treatment phase.|||mEq/L||Standard Deviation|Mean
2625314|NCT01913470|Secondary|Change in Triglyceride Levels From Baseline to End of Treatment (8 Weeks of Treatment)|For children aged 10 to 19, triglyceride levels of less than 90 is considered acceptable, 90 to 129 is borderline high, and greater than or equal to 130 and over is high.|Baseline (Week 0 and 14), End of treatment (Week 8 and 22)|The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment. One participant is missing data for the endpoint measurement of triglyceride levels, following 8 weeks of losartan treatment.|||mg/dL||Standard Deviation|Mean
2625315|NCT01913470|Secondary|Change in Cholesterol Levels From Baseline to End of Treatment (8 Weeks of Treatment)|For children, a cholesterol level of less than 170 is considered acceptable, 170-199 is borderline high, and 200 and over is high.|Baseline (Week 0 and 14), End of treatment (Week 8 and 22)|The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment. One additional participant in each treatment group is missing the end of treatment cholesterol level measurement.|||mg/dL||Standard Deviation|Mean
2625316|NCT01913470|Primary|Change in Alanine Aminotransferase (ALT) From Baseline to End of Treatment (8 Weeks of Treatment)|The principal objective of this blinded, placebo controlled, crossover pilot study is to evaluate whether 8 weeks of losartan in children with nonalcoholic steatohepatitis (NASH) will decrease inflammation as measured by ALT.|Baseline (Weeks 0 and 14), Endpoint (Weeks 8 and 22)|In this blinded, crossover treatment, study participants received losartan or a placebo for 8 weeks, then completed a 6 week washout period before crossing over to the other treatment for 8 weeks. The placebo results for four participants in the losartan followed by placebo arm were not usable due to carry over effects from the active treatment.|||U/L||Standard Deviation|Mean
2625317|NCT01913405|Secondary|Clinically Significant Changes in Routine Laboratory Parameters- Hematology and Chemistry|Changes in clinical chemistry and hematology parameters from a normal or abnormal not clinically significant (ncs) result at screening to an abnormal and clinically significant (cs) result at the end of study assessment (EOS) are listed. Changes did occur in the following laboratory parameters: Alanine Aminotransferase (ALT) (U/L), Hemoglobin (g/L), Hematocrit, Erythrocytes(TI/L), Eosinophils/Leucocytes.|Throughout the entire study period from screening to completion/termination (variable for each participant and depends on the nature of the invasive procedure (treatment period ranged from 43 days to 162 days).|The outcome measure data include surgical enrollments with results both at screening and at the end of the study for each assay.|||Surgeries|Surgeries||Count of Units
2625318|NCT01913405|Secondary|Clinically Significant Changes in Vital Signs - Pulse Rate|Changes in the pulse rate (beats/minute) were assessed 15 minutes after the PK/IR infusion and compared to the pre-infusion values.|Vital signs measurement prior to the PK/IR infusion and 15 minutes post-infusion.|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855. Pre-infusion and 15 min post-infusion vital signs measurements are not available for all surgeries. 15 min. post-infusion measure includes 1 hour post infusion measure for 2 subjects.|||beats/minute|Surgeries|Inter-Quartile Range|Median
2625319|NCT01913405|Secondary|Clinically Significant Changes in Vital Signs - Respiratory Rate|Changes in Respiratory rate were assessed 15 minutes after the PK/IR infusion and compared to the pre-infusion values.|Vital signs measurement prior to the PK/IR infusion and 15 minutes post-infusion.|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855. Pre-infusion and 15 min post-infusion vital signs measurements are not available for all surgeries. 15 min. post-infusion measure includes 1 hour post infusion measure for 2 subjects.|||breaths/minute|Surgeries|Inter-Quartile Range|Median
2625358|NCT01913353|Secondary|Lesion Area in mm2 at Day 13-15 After Scarification With ACAM2000|Lesion area was measured by the Investigator using the SilhouetteConnect camera system and confirmed by the blinded ITRC.|Day 13-15 after ACAM2000 scarification|Per-protocol Set|||mm2||95% Confidence Interval|Median
2625320|NCT01913405|Secondary|Clinically Significant Changes in Vital Signs - Systolic and Diastolic Blood Pressure (BP)|Changes in systolic and diastolic blood pressure (mmHg) were assessed 15 minutes after the PK/IR infusion and compared to the pre-infusion values.|Vital signs measurement prior to the PK/IR infusion and 15 minutes post-infusion.|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855. Pre-infusion and 15 min post-infusion vital signs measurements are not available for all surgeries. 15 min. post-infusion measure includes 1 hour post infusion measure for 2 subjects.|||mmHg|Surgeries|Inter-Quartile Range|Median
2625321|NCT01913405|Secondary|Clinically Significant Changes in Vital Signs - Body Temperature|Changes in body temperature were assessed 15 minutes after the PK/IR infusion and compared to the pre-infusion values.|Vital signs measurement prior to the PK/IR infusion and 15 minutes post-infusion.|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855. Pre-infusion and 15 min post-infusion vital signs measurements are not available for all surgeries. 15 min. post-infusion measure includes 1 hour post infusion measure for 2 subjects.|||°Celsius|Surgeries|Inter-Quartile Range|Median
2625322|NCT01913405|Secondary|Other Investigational Product (IP) - Related Adverse Events||Throughout the entire study period from screening to completion/termination. For each participant the duration of treatment and the entire study period depended on the nature of the invasive procedure (ranged from 43 days to 162 days).|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855.|||Participants|||Count of Participants
2625323|NCT01913405|Secondary|Incidence of Severe Allergic Reactions (e.g. Anaphylaxis)||Throughout the entire study period from screening to completion/termination. For each participant the duration of treatment and the entire study period depended on the nature of the invasive procedure (ranged from 43 days to 162 days).|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855.|||Participants|||Count of Participants
2625324|NCT01913405|Secondary|Occurrence of Thrombotic Events||Throughout the entire study period from screening to completion/termination. For each participant the duration of treatment and the entire study period depended on the nature of the invasive procedure (ranged from 43 days to 162 days).|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855.|||Participants|||Count of Participants
2625325|NCT01913405|Secondary|Development of Treatment Emerging Anti-chinese Hamster Ovary (CHO) Antibodies|A 72-hour washout period is required prior to immunogenicity tests.|Up to 105 days prior to surgery (Screening visit); and End of Study Visit (variable for each participant and depends on the nature of the invasive procedure (treatment period ranged from 43 days to 162 days).|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855.|||Participants|||Count of Participants
2625326|NCT01913405|Secondary|Development of Treatment Emerging Binding Antibodies to Factor VIII (FVIII), Treatment Emergent Binding Antibodies to PEGylated Recombinant FVIII (BX855), and Treatment Emerging Binding Antibodies to Polyethylene Glycol (PEG)|A 72-hour washout period is required prior to immunogenicity tests.|Up to 105 days prior to surgery (Screening visit); and End of Study Visit (variable for each participant and depends on the nature of the invasive procedure (treatment period ranged from 43 days to 162 days).|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855.|||Participants|||Count of Participants
2625327|NCT01913405|Secondary|Development of Inhibitory Antibodies to Factor VIII (FVIII)|Immunogenicity assessment using FVIII inhibitor by Nijmegen method. A 72-hour washout period is required prior to immunogenicity tests.|Up to 105 days prior to surgery (Screening visit); and End of Study Visit (variable for each participant and depends on the nature of the invasive procedure (treatment period ranged from 43 days to 162 days).|The safety analysis data set was used for the analysis of this outcome measure including all participants who received at least one infusion of BAX855.|||Participants|||Count of Participants
2625328|NCT01913405|Secondary|Pharmacokinetics (PK) - Incremental Recovery(IR)|"Following at least a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period.~Incremental recovery (IR) was calculated as C post infusion minus C pre-infusion divided by the dose.~Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results."|PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.|For measurement at 15 min post-infusion only 23 surgeries in 18 participants were available for analysis.|||(IU/dL):(IU/kg)|Surgeries|Standard Deviation|Mean
2625329|NCT01913405|Secondary|Pharmacokinetics (PK) - Apparent Volume of Distribution at Steady State (Vss)|"Following at least a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period.~Apparent steady state volume of distribution (Vss) was calculated as dose multiplied with AUMC(0-inf) divided by AUC(0-inf) to square.~Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results."|PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.||||dL/kg|Surgeries|Standard Deviation|Mean
2625330|NCT01913405|Secondary|Pharmacokinetics (PK) - Clearance (CL)|"Following a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period.~Systemic clearance (CL) was calculated as the dose in IU/kg divided by the total AUC.~Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results. h = hours"|PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.||||dL/(kg*h)|Surgeries|Standard Deviation|Mean
2625359|NCT01913353|Secondary|Lesion Area in mm2 at Day 6-8 After Scarification With ACAM2000|Lesion area was measured by the Investigator using the SilhouetteConnect camera system and confirmed by the blinded ITRC.|Day 6-8 after ACAM2000 scarification|Per-protocol Set|||mm2||95% Confidence Interval|Median
2625331|NCT01913405|Secondary|Pharmacokinetics (PK) - Mean Residence Time (MRT)|"Following at least a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period.~Mean residence time (MRT) was calculated as total area under the moment curve divided by the total area under the curve.~Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results."|PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.||||Hours|Surgeries|Standard Deviation|Mean
2625332|NCT01913405|Secondary|Pharmacokinetics (PK) - Terminal Half-life (T1/2)|"Following at least a 72 hour washout period a single dose of BAX855 will be administered. The PK profiles will be used to guide dosing and dosing frequency during the perioperative time period.~Terminal or disposition half-life (HL) was calculated as log e(2)/λz where the terminal or disposition rate constant (λz) was estimated as the slope of a log-linear least squares regression model.~Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results. Terminal half life is the time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%."|PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.||||Hours|Surgeries|Standard Deviation|Mean
2625333|NCT01913405|Secondary|Pharmacokinetics (PK) - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours Post-infusion (AUC0-96h)|"Following at least a 72 hour (h) washout period a single dose of BAX855 will be administered. The PK profiles was used to guide dosing and dosing frequency during the perioperative time period.~The area under the plasma concentration/time curve from time 0 to 96 hours postinfusion (AUC 0-96h) was computed using the linear trapezoidal rule. For the calculation of AUC 0-96h the levels at 96 hours were linearly interpolated/extrapolated from the 2 nearest sampling time points.~Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results."|PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.||||IU*h/dL|Surgeries|Standard Deviation|Mean
2625334|NCT01913405|Secondary|Pharmacokinetics (PK) - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞)|"Following at least a 72 hour washout period a single dose of BAX855 was administered. The PK profiles was used to guide dosing and dosing frequency during the perioperative time period.~The area under the plasma concentration/time curve from time 0 to infinity (AUC 0-inf) and the area under the first movement curve from time 0 to infinity (AUMC 0-inf) was calculated as the sum of AUC and AUMC from time 0 to the time of the last quantifiable concentration plus a tail area correction calculated as Ct/λz and Ct/λz(t+1/λz), respectively, where Ct is the last quantifiable concentration, t is the time of last quantifiable concentration and λz is the terminal or disposition rate constant.~Main analysis was done on the one-stage clotting assay results, supportive analysis was done on the chromogenic assay results."|PK measurements were done within 30 minutes pre-infusion, and post infusion at 15 (± 5) minutes, 3 hours (± 30 minutes), 9 hours (± 30 minutes), 32 (± 2) hours, 56 (± 4) hours and 96 (± 4) hours.||||IU*h/dL|Surgeries|Standard Deviation|Mean
2625335|NCT01913405|Secondary|Consumption of BAX855|Daily and total weight-adjusted consumption of BAX855 per subject.|From initial loading dose until discharge for daily weight-adjusted dose and from first infusion (PK/IR) until end of study for total weight-adjusted dose.|The full analysis group comprises the groups with major orthopedic, major non-orthopedic and minor surgery. Number of surgeries/participants with BAX855 consumption varies on each postoperative day.|||IU/kg|Surgeries|Standard Deviation|Mean
2625336|NCT01913405|Secondary|Occurrence of Bleeding Episodes and Additional Need for Surgical Intervention|Any clinically relevant bleeding episodes (as assessed by the investigator) as well as the need for any further surgical interventions were recorded. If the subject had not resumed his previous treatment after discharge, the occurrence and treatment of bleeding episodes were recorded in the subject's diary.|Intra- and post-operative period, until the last intensified treatment after hospital discharge (minor surgery 1-3 days, major surgery average approximately 2 weeks)|Only surgeries/participants that have encountered bleeding episodes are reported for the analysis of bleeding episodes (5 surgeries in 5 participants) and all surgeries/participants are reported for the analysis of the need for surgical intervention.|||Events|Surgeries||Number
2625337|NCT01913405|Secondary|Transfusion Requirements|Volume of blood, red blood cells, platelets, and other blood products transfused. Only packed red blood cells were transfused in this study.|From initiation of the surgery to 24 hours after completion of the surgery.|The full analysis group comprises the groups with major orthopedic, major non-orthopedic and minor surgery. Only participants who received blood transfusions are included in this analysis.|||Milliliter|Surgeries|Standard Deviation|Mean
2625338|NCT01913405|Secondary|Overall Perioperative Blood Loss|Actual overall perioperative blood loss (assessed at the end of surgery, at postoperative day 1 and until discharge or day 14 - whichever is first) was compared to the estimated volume of expected average and maximum blood loss in a hemostatically normal individual of the same sex, age and stature as the study participant. Expected perioperative blood loss was predicted pre-operatively by the investigator/surgeon.|From start of surgery until discharge or day 14, whichever occurred first.|The full analysis group comprises the groups with major orthopedic, major non-orthopedic and minor surgery.|||Milliliter|Surgeries|Inter-Quartile Range|Median
2625339|NCT01913405|Secondary|Postoperative Blood Loss|Actual post-operative blood loss assessed at postoperative day 1 was compared to the estimated volume of expected average and maximum blood loss in a hemostatically normal individual of the same sex, age and stature as the study participant. Expected postoperative blood loss was predicted pre-operatively by the investigator/surgeon.|From completion of surgery until 24 hours after surgery.|The full analysis group comprises the groups with major orthopedic, major non-orthopedic and minor surgery.|||Milliliter|Surgeries|Inter-Quartile Range|Median
2625360|NCT01913353|Secondary|Individual Take as Classified by a Blinded Independent Take Review Committee (ITRC)|Take was assessed as either full, partial, or absent take by the ITRC based on Day 6-8 evaluations following ACAM2000 vaccination using subject profiles that contained supportive data up to Day 14 following ACAM2000 vaccination (in accordance with the ITRC Charter).|Day 6-8 visit following ACAM2000 vaccination|Per-protocol Set|||percentage of subjects||95% Confidence Interval|Number
2625340|NCT01913405|Secondary|Intraoperative Blood Loss|Actual intraoperative blood loss was assessed at the end of surgery and was compared to the estimated volume of expected average and maximum blood loss in a hemostatically normal individual of the same sex, age and stature as the study participant. Expected intraoperative blood loss was predicted preoperatively by the investigator/surgeon.|From initiation of surgery until end of surgery.|The full analysis group comprises the groups with major orthopedic, major non-orthopedic and minor surgery.|||Milliliter|Surgeries|Inter-Quartile Range|Median
2625341|NCT01913405|Primary|Global Hemostatic Efficacy Assessment Score (GHEA) - Composed of 3 Individual Ratings|"GHEA=Sum of 1-3 ratings: Excellent: 7-9 (no category <2), Good: 5-7 (no category <1), Fair: 3-4 (no category <1)~1. Intraoperative and 2. Postoperative (postoperative day 1) hemostatic efficacy assessments: Excellent=3: Blood Loss (BL) ≤ than expected for procedure type in non-hemophilic population (NHP) (≤100%), Good=2: BL ≤50% more than expect. for procedure type in NHP (101-150%), Fair=1: BL >50% more than expect. for procedure type in NHP (>150%), None=0: Significant bleeding-requiring rescue therapy (RT) 3. Perioperative hemostatic efficacy assessment (day 14 or discharge, whatever is first): Excellent=3: BL and required blood transfusions (BT) less than or similar (≤100%) to that expected for procedure type in NHP, Good=2: BL ≤50% more (101-150%) and BT less than or similar to that expected for procedure type in NHP, Fair=1: BL >50% more (>150%) and BT greater than expected in NHP, None=0: Significant bleeding-requiring RT, BT substantially greater than expected in NHP"|Hemostatic efficacy assessments were performed intraoperatively, postoperatively on day 1 (approximately 24 hours after surgery) and perioperatively at day 14 or discharge (whichever was first).|Full analysis group comprises groups major orthopedic and non-orthopedic and minor surgery. Main analysis was done on the full analysis group (at least one hemostatic assessment available) and supportive analysis was done on the per protocol analysis group (all hemostatic assessments available).|||Percentage of surgeries|Surgeries|90% Confidence Interval|Number
2625342|NCT01913353|Secondary|ELISA Seroconversion Rates at Peak Visits|"Seroconversion rate based on ELISA. Seroconversion is defined as the appearance of antibody titers greater than or equal detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available."|Group 1 at Week 6; Group 2 at Week 4|Per-protocol Set for Immunogenicity|||percentage of subjects||95% Confidence Interval|Number
2625343|NCT01913353|Secondary|PRNT Seroconversion Rates at Peak Visits|"Seroconversion rate based on PRNT. Seroconversion is defined as the appearance of antibody titers greater than or equal detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available."|Group 1 at Week 6; Group 2 at Week 4|Per-protocol Set for Immunogenicity|||percentage of subjects||95% Confidence Interval|Number
2625344|NCT01913353|Secondary|GMTs as Measured by Vaccinia-specific PRNT|GMT based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.|within 12 weeks|Per-protocol Set for Immunogenicity|||Titer||95% Confidence Interval|Geometric Mean
2625345|NCT01913353|Secondary|GMTs as Measured by Vaccinia-specific ELISA|GMT based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.|within 12 weeks|Per-protocol Set for Immunogenicity|||Titer||95% Confidence Interval|Geometric Mean
2625346|NCT01913353|Secondary|GMTs at the Individual Peak Measured by Vaccinia-specific PRNT|"Individual Peak was the maximum titer per subject from Visit 1 to Visit 7 (Week 8) in Group 1 and maximum titer from Visit 1 to Visit 6 (Week 8) in Group 2.~Titers below the detection limit are included with a value of 1."|within 8 weeks (for both groups)|Per-protocol Set for Immunogenicity|||Titer||95% Confidence Interval|Geometric Mean
2625347|NCT01913353|Secondary|GMTs at the Peak Visits and Individual Peak Measured by Vaccinia-specific ELISA|"Peak Visit was defined as Day 42 for Group 1 and Day 28 for Group 2. Individual Peak was the maximum titer per subject from Visit 1 to Visit 7 (Week 8) in Group 1 and maximum titer from Visit 1 to Visit 6 (Week 8) in Group 2.~Titers below the detection limit are included with a value of 1."|within 8 weeks (for both groups)|Per-protocol Set for Immunogenicity|||Titer||95% Confidence Interval|Geometric Mean
2625348|NCT01913353|Secondary|Major Lesion Size, Major Erythema, and Major Induration Diameter|Daily measurement of major lesion size, major erythema, and major induration diameter (mm) based on physical appearance of vaccination site as documented in the memory aid. If the shape of the lesion, erythema [excludes lymphangitis], and induration observed was not round but rather asymmetrical, then the largest [or major] cross-sectional measurement was recorded.|Within 15 days after scarification with ACAM2000|Full Analysis Set|||mm||95% Confidence Interval|Median
2625349|NCT01913353|Secondary|Solicited Local AEs: Intensity|Incidence of solicited local AEs (pain, redness [erythema], swelling, induration, itching [pruritus])|within 15 days after vaccination|Full Analysis Set|||Participants|||Count of Participants
2625350|NCT01913353|Secondary|Incidence of Lymphadenopathy|Incidence of events of Lymphadenopathy. Pooled solicited and unsolicited events.|within 29 days after vaccination|Full Analysis Set|||Participants|||Count of Participants
2625351|NCT01913353|Secondary|Solicited General AEs|Occurrence, intensity and relationship of solicited general AEs (body temperature [fever], headache, myalgia [muscle pain], chills, nausea, fatigue, malaise)|within 15 days after vaccination|Full Analysis Set|||Participants|||Count of Participants
2625352|NCT01913353|Secondary|Intensity of Any Non-serious AEs|Presentation of non-serious AEs by intensity|within 29 days after vaccination|Full Analysis Set|||Events|||Number
2625353|NCT01913353|Secondary|Relationship to Vaccine of Any Non-serious AEs|Presentation of non-serious AEs by relationship to study vaccine|within 29 days after vaccination|Full Analysis Set|||Events|||Number
2625354|NCT01913353|Secondary|Related Grade >=3 Adverse Events|Incidence of any Grade 3 or 4 adverse events (AEs) possibly, probably, or definitely related to the vaccine. Pooled solicited (general only) and unsolicited AEs.|within 29 days after vaccination|Full Analysis Set|||Participants|||Count of Participants
2625355|NCT01913353|Secondary|Incidence of Any Cardiac Sign or Symptom Indicating a Case of Myo-/Pericarditis, i.e. Adverse Events of Special Interest (AESIs)|In this clinical trial, an AESI was defined as any cardiac sign or symptom developed since the first vaccination, any ECG changes determined to be clinically significant, or any cardiac enzyme results of Troponin I ≥ 2 x ULN.|Within 38 weeks for Group 1 and 30 weeks for Group 2|Full Analysis Set|||Participants|||Count of Participants
2625361|NCT01913353|Secondary|Investigator-measured Lesion Diameter in mm at Day 13-15 After Scarification With ACAM2000|The lesion diameter at Day 13-15 was defined as the major lesion diameter measured on Day 13-15 (after scarification)|Day 13-15 after ACAM2000 scarification|Per-protocol Set|||mm||95% Confidence Interval|Median
2625362|NCT01913353|Secondary|Investigator-measured Lesion Diameter in mm at Day 6-8 After Scarification With ACAM2000|The lesion diameter at Day 6-8 was defined as the major lesion diameter measured on Day 6-8 (after scarification)|Day 6-8 after ACAM2000 scarification|Per-protocol Set|||mm||95% Confidence Interval|Median
2625363|NCT01913353|Secondary|Investigator-measured Maximum Lesion Diameter (MLD) in mm After Scarification With ACAM2000|The MLD was defined as the largest major diameter measured across the lesion on Day 6-8 (after scarification) or Day 13-15 (after scarification)|Day 6-8 and Day 13-15 after ACAM2000 scarification|Per-protocol Set|||mm||95% Confidence Interval|Median
2625364|NCT01913353|Primary|Maximum Lesion Area (MLA) in mm2 After Scarification With ACAM2000®|The MLA was defined as the maximum of two measurements: the lesion area measured on Day 6-8 (after scarification) or the lesion area measured on Day 13-15 (after scarification). This was measured using the SilhouetteConnect camera system, and confirmed by the Independent Take Review Committee (ITRC).|Day 6-8, 13-15 after 3rd Vaccination for Group 1 and Day 6-8, 13-15 after 1st vaccination for Group 2|Per-protocol Set|||mm2||95% Confidence Interval|Median
2625365|NCT01913353|Primary|Plaque Reduction Neutralization Test (PRNT) Geometric Mean Titer (GMT) at the Peak Visits|GMT based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of 1.|Day 42 for Group 1 and Day 28 for Group 2|Per-protocol Set for Immunogenicity|||Titer||95% Confidence Interval|Geometric Mean
2625366|NCT01913327|Other Pre-specified|Psychiatric Symptoms|Common symptoms of schizophrenia (including psychotic symptoms, negative symptoms, depression symptoms) will be directly compared between the aripiprazole and risperidone-treated groups.|8 weeks|Trial was terminated early therefore no outcome data are available.||||||
2625367|NCT01913327|Secondary|Brain Activation in Response to Single-dose Modafinil|Patterns of brain activation during cognitive task performance will be compared after modafinil versus after placebo, in the two antipsychotic-treated groups after 8 weeks of antipsychotic treatment.|one day|Trial was terminated early therefore there are no outcome data.||||||
2625368|NCT01913327|Secondary|Cognitive Performance|Performance on the cognitive task administered during fMRI will be directly compared between the two treatment groups.|8 weeks|Trial was terminated early therefore no outcome data are available.||||||
2625369|NCT01913327|Primary|Brain Activation by fMRI|The magnitude of BOLD signal change associated with cognitive task performance will be directly compared between the aripiprazole and risperidone-treated groups, as well as the degree of functional connectivity between the locus coeruleus and the prefrontal cortex, also during during cognitive task performance.|8 weeks|Trial was terminated early therefore no outcome data are available.||||||
2625370|NCT01913314|Secondary|Relative Abundance of LY2835219 and Metabolites of LY2835219 in Plasma|The relative abundance of LY2835219 or its metabolites in plasma were estimated based on AUC(0-∞) and reported as a percentage of total plasma radioactivity. The relative abundance of LY2835219 or its metabolites calculated as = [AUC (0-∞) of LY2835219 or its metabolites in plasma / AUC (0-∞) of total plasma radioactivity] * 100.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose|Participants who received study drug and had evaluable PK AUC(0-∞) data.|||percentage of total plasma radioactivity|||Number
2625371|NCT01913314|Secondary|Relative Abundance of LY2835219 and Metabolites of LY2835219 Eliminated in Urine and Feces|The abundance (as percentage dose) of LY2835219 or its metabolites eliminated in feces is calculated as = (amount of LY2835219 or its metabolites recovered in feces / total amount administered) * 100. Due to low radioactivity of dose recovered in urine, further quantitative profiling of urine was not conducted.|Predose through 216 h postdose; Fecal samples collected at 24-h intervals|Participants who received study drug and had evaluable PK data. No participants were analyzed for relative abundance of LY2835219 and metabolites of LY2835219 in urine.|||percentage of radioactive dose excreted|||Number
2625372|NCT01913314|Secondary|Plasma PK of Radioactivity: AUC(0-∞)||Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose|Participants who received study drug and had evaluable PK data.|||ng Eq*h/g||Geometric Coefficient of Variation|Geometric Mean
2625373|NCT01913314|Secondary|Plasma PK of LY2835219 and Metabolite of LY2835219: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)]||Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose|Participants who received study drug and had evaluable PK AUC(0-∞) data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2625374|NCT01913314|Secondary|Plasma PK of Radioactivity: AUC(0 to Tlast)|The PK of radioactivity was measured as nanogram equivalents times hours per gram (ng Eq*h/g).|Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose|Participants who received study drug and had evaluable PK AUC(0-tlast) data.|||ng Eq*h/g||Geometric Coefficient of Variation|Geometric Mean
2625375|NCT01913314|Secondary|Plasma PK of LY2835219 and Metabolite of LY2835219: Area Under the Concentration-Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC(0-tlast)]||Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose|Participants who received study drug and had evaluable PK AUC(0-tlast) data.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2625376|NCT01913314|Secondary|Plasma PK of LY2835219, Metabolite of LY2835219, and Radioactivity: Time of Maximum Observed Concentration (Tmax)||Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose|Participants who received study drug and evaluable PK tmax data.|||h||Full Range|Median
2625377|NCT01913314|Secondary|Plasma PK of Radioactivity: Cmax||Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose|Participants who received study drug and had evaluable PK Cmax data.|||nanogram equivalents per gram (ng Eq/g)||Geometric Coefficient of Variation|Geometric Mean
2625378|NCT01913314|Secondary|Plasma Pharmacokinetics (PK) of LY2835219 and Metabolite of LY2835219: Maximum Observed Concentration (Cmax)||Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 h postdose, thereafter at 24-h intervals up to Day 14 postdose|Participants who received study drug and had evaluable PK data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2625379|NCT01913314|Primary|Urinary and Fecal Excretion of LY2835219-Related Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered|The percentage of the total radioactive dose administered that was excreted in urine or feces = (amount of radioactive dose recovered in urine or feces / total radioactive dose administered) * 100.|Predose up to Day 14 postdose; Fecal samples collected at 24-hour (h) intervals; Urine collected at 0 to 6 h, 6 to 12 h, and 12 to 24 h postdose and at 24-h intervals thereafter up to Day 14 postdose|Participants who received study drug.|||percentage radioactive dose administered||Standard Deviation|Mean
2625380|NCT01913041|Primary|The Incidence of Perioperative Hypothermia|Hypothermia incidence is defined as the percentage of the participants who occured hypothermia(Core temperature <36℃) accounts for the total amount of participants.|Perioperative period started from anesthesia induction to surgery ended|Actually 869 patients are enrolled, among which 39 patients were eliminated for the reasons operation cancelled temporarily or violate the eligible criteria, so 830 participants for analysis was determined to be analyzed per protocol in the end.|||Percentage of hypothermia participants|||Number
2625381|NCT01912963|Post-Hoc|1-year Overall Survival|1-year overall survival is the probability of patients remaining alive 1 year from study entry estimated using Kaplan-Meier (KM) methods which censors patients at date of last follow-up.|In long-term follow-up, participants were followed for survival every 6 months up to 1 year after treatment discontinuation. Median follow-up in this study cohort was 15.6 months (up to 20).||||probability||95% Confidence Interval|Number
2625382|NCT01912963|Secondary|Grade 4 Treatment-Related Toxicity Rate|Grade 4 treatment-related toxicity rate is the percentage of participants experiencing at least one treatment-related grade 4 adverse event (AE) of any type during the time of observation as reported on case report forms. 'Treatment-related' is a treatment attribution of possibly, probably or definite based on the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 4.|AEs were assessed every cycle on treatment. Median (range) treatment duration was 7(2-25) cycles for Cohort A and 4(3-18) cycles for Cohort B.||||percentage of participants||95% Confidence Interval|Number
2625383|NCT01912963|Secondary|Overall Survival (OS) [Phase II]|Overall survival (OS) is defined as the time from the date of registration to the date of death, or censored at the date the participant was last known alive. OS is estimated based on the Kaplan-Meier method.|In long-term follow-up, participants were followed for survival every 6 months up to 1 year after treatment discontinuation. Median follow-up in this study cohort was 15.6 months (up to 20).||||months||95% Confidence Interval|Median
2625384|NCT01912963|Secondary|Progression-free Survival (PFS) [Phase II]|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or equivocal progression of non-target lesions.(whichever occurs first).|Disease was evaluated radiologically at baseline, every 2 or 3 cycles in the treatment and extension phase, respectively, and every 9 weeks post-treatment until disease progression. Median follow-up in this study cohort was 15.6 months (up to 20).||||months||95% Confidence Interval|Median
2625385|NCT01912963|Secondary|Clinical Benefit Rate (CBR) [Phase II]|The clinical benefit rate (CBR) was defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) for 24 weeks or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria.|Disease was evaluated radiologically at baseline and every 2 or 3 cycles in the treatment and extension phase, respectively. Median (range) treatment duration was 7(2-25) cycles for Cohort A and 4(3-18) cycles for Cohort B.||||proportion of participants||95% Confidence Interval|Number
2625386|NCT01912963|Primary|Objective Response Rate (ORR) [Phase II]|The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 2 or 3 cycles in the treatment and extension phase, respectively. Median (range) treatment duration was 7(2-25) cycles for Cohort A and 4(3-18) cycles for Cohort B.|The analysis dataset is comprised all enrolled Phase II patients.|||proportion of participants||95% Confidence Interval|Number
2625387|NCT01912963|Primary|Dose Limiting Toxicity (DLT) [Phase I]|A DLT was defined as an adverse event that (a) is deemed by the investigator to be probably or likely related with protocol therapy and (b) occurs during and/or begins during the first cycle of the study treatment, and (c) meets any of the following criteria: grade 4 hematologic toxicity with > 1 week of duration, grade 3 or 4 febrile neutropenia of any duration; or grade 3 or 4 non hematologic toxicity (excluding nausea, vomiting, and alopecia).|The observation period for DLTs was the 1st cycle of treatment.||||Participants|||Count of Participants
2625388|NCT01912963|Primary|Eribulin the Recommended Phase II Dose (RP2D) [Phase I]|The RP2D of eribulin in combination with pertuzumab and trastuzumab is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The RP2D is defined as the highest dose at which fewer than one-third of six patients experience a DLT. In this Phase I run-in, only 2 dose levels were under evaluation: a starting dose (D1) and a de-escalation dose (D-1) if 2 or more DLTs are observed in Dose Level 1 (DL1).|The observation period for the RP2D was the 1st cycle of treatment.|The analysis dataset is comprised all enrolled Phase I participants.|||mg/m^2|||Number
2625424|NCT01912729|Primary|Program Logins Per Participant by Week.|Program usage data were examined by number of logins per participant by week. Participants in the study tended to access the program multiple times and explored the program tools.|Weeks 1-8||||number of program logins||Standard Deviation|Mean
2625389|NCT01912872|Secondary|Asthma Quality of Life Questionnaire (AQLQ) at Baseline|The quality of life will be measured by the standardized version of the Asthma Quality of Life Questionnaire (AQLQ[S]) score for adults and the pediatric version of the AQLQ(S) for pediatric participants (PAQLQ[S]) . The AQLQ(S) and PAQLQ(S0 contain 4 domains (activity limitations, symptoms, emotional function, and environmental stimuli), with a total of 32 items; each item is measured in a 7-point Likert scale of 1 to 7 (1 = severe impairment, 7 = no impairment). All items are weighted equally. Mean score is calculated across all items within each domain and the overall score is the mean score of the 32 items.|Baseline|Number of participants with a baseline measurement within the ITT Pediatric and Adult population.|||scores on a scale||Standard Deviation|Mean
2625390|NCT01912872|Secondary|Asthma Control Questionnaire (ACQ) at Baseline|The Asthma Control Questionnaire (ACQ) has six questions to be answered by the participants, each with a 7 point scale (0-good control, 6-poor control), and one question where the actual pre-bronchodilator Forced expiratory volume in 1 second (FEV1) value expressed in % of predicted FEV1 was classified to scores from 0 (> 95% of predicted) to 6 (< 50% of predicted). The overall score is the average of the 7 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma.|Baseline|Number of participants with a baseline measurement within the ITT Pediatric and Adult population.|||scores on a scale||Standard Deviation|Mean
2625391|NCT01912872|Secondary|Participants Requiring Oral Systemic Corticosteroids During the 12 Month Study Duration|Number of days of concomitant medications use reported by participants at all visits via diaries.|12 month treatment duration|Number of patients requiring oral systemic corticosteroids within the ITT Pediatric and Adult population.|||Number of days||Standard Deviation|Mean
2625392|NCT01912872|Secondary|Control of Asthma Symptoms- Rescue Medication Use|The clinical control of asthma was defined according to the following criteria (GINA 2012): 1-Daytime symptoms: none or less than twice a week 2-Limitations of daily activities: none 3-Nocturnal symptoms or awakening because of asthma: none 4-Need of relief or rescue medication: none or less than twice a week 5-Lung function (PEF or FEV1) without administration of bronchodilator: normal|12 month treatment duration|Pediatric and Adult ITT population. ITT population received at least one dose of study drug and one post-baseline assessment of the primary/secondary efficacy variables.|||participants|||Number
2625393|NCT01912872|Secondary|Control of Asthma Symptoms|The clinical control of asthma was defined according to the following criteria (GINA 2012): 1-Daytime symptoms: none or less than twice a week 2-Limitations of daily activities: none 3-Nocturnal symptoms or awakening because of asthma: none 4-Need of relief or rescue medication: none or less than twice a week 5-Lung function (PEF or FEV1) without administration of bronchodilator: normal|12 month treatment duration|Pediatric and Adult ITT population. ITT population received at least one dose of study drug and one post-baseline assessment of the primary/secondary efficacy variables.|||Number of days||Standard Deviation|Mean
2625394|NCT01912872|Secondary|Control of Asthma Symptoms- Daytime Symptoms|The clinical control of asthma was defined according to the following criteria (GINA 2012): 1-Daytime symptoms: none or less than twice a week 2-Limitations of daily activities: none 3-Nocturnal symptoms or awakening because of asthma: none 4-Need of relief or rescue medication: none or less than twice a week 5-Lung function (PEF or FEV1) without administration of bronchodilator: normal|12 month treatment duration|Pediatric and Adult ITT population. ITT population received at least one dose of study drug and one post-baseline assessment of the primary/secondary efficacy variables.|||percentage of participants|||Number
2625395|NCT01912872|Secondary|Days Missed in School/Work Due to Asthma Exacerbation Episodes|Participants /parent/legal guarding reported number of missed days of school or work at each study visit via diaries.|12 month treatment duration|Pediatric and Adult ITT population. ITT population received at least one dose of study drug and one post-baseline assessment of the primary/secondary efficacy variables.|||days|||Number
2625396|NCT01912872|Secondary|Number of Hospital Admissions Due to Asthma Exacerbation|A hospital admission is defined as admissions to hospital involving a stay of at least 24 hours.|12 month treatment duration|Pediatric and Adult ITT population. ITT population received at least one dose of study drug and one post-baseline assessment of the primary/secondary efficacy variables.|||hospital admissions|||Number
2625397|NCT01912872|Primary|The Mean Prescribed Budesonide Dose (μg) at Baseline|prescribed budesonide dose (in μg) at Baseline in intention to treat population and in intention to treat population|Baseline|Pediatric and Adult intent-to-treat (ITT) and per protocol (PP) populations. ITT population received at least one dose of study drug and one post-baseline assessment of the primary/secondary efficacy variables. PP population was participants that completed 12 months of treatment, had a valid assessment of the primary efficacy variable at Week 24.|||μg||Standard Deviation|Mean
2625398|NCT01912781|Primary|Film Deposit Area Covered|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all randomized subjects. Here, “n” is the total number of subjects with film deposits in each treatment group, respectively, by visit.|||percentage of lens area||Standard Deviation|Mean
2625399|NCT01912781|Primary|Crystalline Deposit Area Covered|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all randomized subjects. Here, “n” is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit.|||percentage of lens area||Standard Deviation|Mean
2625400|NCT01912781|Primary|"Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling."|Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.|||percentage of subjects|||Number
2625401|NCT01912781|Primary|"Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."|Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.|||percentage of subjects|||Number
2625402|NCT01912781|Primary|"Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day."|Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.|||percentage of subjects|||Number
2625403|NCT01912781|Primary|Number of Unscheduled Lens Replacements by Reason|No lens replacements were planned during the study. Lenses could be replaced as needed due to loss, damage, or as deemed necessary by the Investigator. If it became necessary to replace a lens, the subject was examined at an unscheduled visit. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.|Up to Day 90|This analysis population includes all randomized subjects.|||lenses|||Number
2625404|NCT01912781|Primary|Average Lens Wear Time|"Subject recorded a response to the question, Averaging over the last 3 days, how many hours per day did you wear your contact lenses? Lens wear time was measured in hours."|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.|||Hours||Standard Deviation|Mean
2625405|NCT01912781|Primary|Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change|Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.|||percentage of subjects|||Number
2625406|NCT01912781|Primary|Average Residual Lens Lysozyme|Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.|Day 90/Early Exit|This analysis population includes all randomized subjects.|||micrograms per lens||Standard Deviation|Mean
2625407|NCT01912781|Primary|Percentage of Subjects With Film Deposits by Type|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all randomized subjects. Here, “n” is the total number of subjects with film deposits in each treatment group, respectively, by visit.|||percentage of subjects|||Number
2625408|NCT01912781|Primary|Percentage of Subjects With Crystalline Deposits by Type|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all randomized subjects. Here, “n” is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit.|||percentage of subjects|||Number
2625409|NCT01912781|Primary|Percentage of Subjects With Visibly Clean Lenses|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|This analysis population includes all subjects with data at visit.|||percentage of subjects|||Number
2625410|NCT01912768|Primary|Film Deposit Area Covered|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with film deposits in each treatment group, respectively, by visit."|||percentage of lens area||Standard Deviation|Mean
2625411|NCT01912768|Primary|Crystalline Deposit Area Covered|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit."|||percentage of lens area||Standard Deviation|Mean
2625412|NCT01912768|Primary|"Likert Item - When I Use This Solution, I Like the Way This Product Feels During Handling."|Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."|||percentage of subjects|||Number
2625413|NCT01912768|Primary|"Likert Item - When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."|Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."|||percentage of subjects|||Number
2625414|NCT01912768|Primary|"Likert Item - When I Use This Solution, my Lenses Are Comfortable All Day."|Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."|||percentage of subjects|||Number
2625415|NCT01912768|Primary|Number of Unscheduled Lens Replacements by Reason|A fresh pair of lenses was dispensed on Day 0, Day 30, and Day 60. Lenses replaced at other times were considered unscheduled. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.|Up to Day 90|This analysis population includes all randomized subjects.|||lenses|||Number
2625416|NCT01912768|Primary|Average Lens Wear Time|"Subject recorded a response to the question, Averaging over the last 3 days, how many hours per day did you wear your contact lenses? Lens wear time was measured in hours."|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."|||Hours||Standard Deviation|Mean
2625417|NCT01912768|Primary|Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change|Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."|||percentage of subjects|||Number
2625418|NCT01912768|Primary|Average Residual Lens Lysozyme|Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.|Day 30/Early Exit|This analysis population includes all subjects with data at visit.|||micrograms per lens||Standard Deviation|Mean
2625419|NCT01912768|Primary|Percentage of Subjects With Film Deposits by Type|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with film deposits in each treatment group, respectively, by visit."|||percentage of subjects|||Number
2625420|NCT01912768|Primary|Percentage of Subjects With Crystalline Deposits by Type|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with crystalline deposits in each treatment group, respectively, by visit."|||percentage of subjects|||Number
2625421|NCT01912768|Primary|Percentage of Subjects With Visibly Clean Lenses|Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. One eye (study eye) contributed to the analysis.|Day 7, Day 30, Day 60, Day 90|"This analysis population includes all randomized subjects. Here, n is the total number of subjects with data in each treatment group, respectively, by visit."|||percentage of subjects|||Number
2625422|NCT01912729|Primary|SUS (System Usability Scale) Questionnaire|The SUS questionnaire is a 10 item measure that assesses usability, acceptability and satisfaction; each item has five response options for respondents, from 1 = Strongly disagree to 5 = Strongly agree. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Specifically, for odd items: subtract one from the user response. For even-numbered items: subtract the user responses from 5. This scales all values from 0 to 4 (with four being the most positive response). Add up the converted responses for each user and multiply that total by 2.5. This converts the range of possible values from 0 to 100 instead of from 0 to 40. A SUS score above a 68 would be considered above average and anything below 68 is below average.|Week 4 and Week 8||||units on a scale||Standard Deviation|Mean
2625423|NCT01912729|Primary|USE (Usefulness, Satisfaction and Ease of Use) Questionnaire|"A modified version of the Usefulness, Satisfaction and Ease of use questionnaire (USE; Lund, 2001) was used, particularly regarding the participants' relationships with the peer network. The USE questionnaire is a 19 item measure of usability with 4 subscales: Usefulness, Ease of Learning, Ease of Use, and Satisfaction. The items are rated on 7 point Likert rating scales, with 1 = Strongly disagree to 7 = Strongly agree.~Lund, A.M., 2001. Measuring Usability with the USE Questionnaire."|Week 4 and Week 8||||units on a scale||Standard Deviation|Mean
2625425|NCT01912716|Secondary|Number of Participants With Moderate or Severe Post-ERCP Pancreatitis|Assessment of whether patients developed either moderate or severe post-ERCP pancreatitis, defined according to established consensus criteria (Cotton et al., Gastrointestinal Endoscopy 1991;37:383-93). Severity of post-ERCP pancreatitis is partly defined according to length of stay. Moderate pancreatitis is defined as a 4-10 day hospitalization. Severe post-ERCP pancreatitis is defined as a hospitalization of greater than 10 days post-ERCP, or development of a complication (eg. pseudocyst or necrosis), or need for intervention (drainage or surgery).|30 days|development of moderate or severe post-ERCP pancreatitis|||Participants|||Count of Participants
2625426|NCT01912716|Primary|Number of Participants Who Developed Post-ERCP Pancreatitis|Assessment of whether patients developed post-ERCP pancreatitis, defined as a new onset of pain (or worsening of existing pain) in the upper abdomen, an elevation in pancreatic enzymes of at least three times the upper limit of the normal range 24 hours after the procedure, and hospitalization for at least two nights.|5 days||||Participants|||Count of Participants
2625427|NCT01912599|Primary|Systolic Pressure|The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.|24 Hours||||mmHg||Standard Deviation|Mean
2625428|NCT01912599|Primary|Diastolic Pressure|The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.|24 Hours||||mmHg||Standard Deviation|Mean
2625429|NCT01912599|Primary|Mean Perfusion Pressure|The value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.|24 Hours||||mmHg||Standard Deviation|Mean
2625430|NCT01912599|Primary|Intraocular Pressure|The IOP provided is the average of all 144 measurements taken during the 24 hour period.|24 Hours||||mEqv.||Standard Deviation|Mean
2625431|NCT01912599|Primary|Arterial Pressure|The blood pressure value shown in the table is the mean of all measurements taken over the 24 hour period, so it is the average value.|24 Hours|"Data for two glaucoma patients were excluded for analysis because~In one patient the IOP recorder malfunctioned just two hours after set up, so data were not available for the entire 24 hours~In the other patient, the wireless sensor was disconnected from the recorder in the middle if the night so data could not be recorded."|||mmHg||Standard Deviation|Mean
2625432|NCT01912495|Secondary|Safety: Treatment Related (Serious) Adverse Events ((S)AE) and Treatment Discontinuation for (S)AE.|only serious adverse events are recorded in this secondary endpoint|72 weeks|57 patients started treatment and were at risk|||participants|||Number
2625433|NCT01912495|Secondary|Alterations of Biomarkers by Therapy Induced Viral Eradication: Viral Sequencing, Mutation Analysis, Gene Expression Analysis, and RNA Analysis.||72 weeks|data were not collected during this study||||||
2625434|NCT01912495|Secondary|SVR 12 Weeks After End of Therapy in Patients That Started Therapy ≤12weeks After the Presumed HCV Infection Date Versus Those After 12 Weeks.|The number of patients having a undetectable HCV RNA 12 weeks after the end of treatment in the group patients that was treated within 12 week of calculated transmission date.|12 weeks|5 patients were treated within 12 weeks after calculated transmission date. All other patients were treated between 12 and 26 weeks after calculated transmission date.|||participants|||Number
2625435|NCT01912495|Secondary|SVR 12 Weeks After End of Therapy in Patients With Already a RVR at Week 1.|The number of patients who were undetectable for HCV at week one that had an undetectable HCV RNA load 12 weeks after the end of treatment|12 weeks|All patients having a rapid viral response at week 4 had a sustained viral response at 12(SVR12) weeks after treatment.|||participants|||Number
2625436|NCT01912495|Secondary|SVR 12 Weeks After the End of All Therapy in the Entire Study Population (With or Without RVR4).|The outcome is a number of all patients who started treatment having an undetectable HCV RNA 12 weeks after the end of therapy|12 weeks|Total intention to treat population|||participants|||Number
2625437|NCT01912495|Primary|Sustained Viral Response(SVR) 12 Weeks of Follow up After the End of All Therapy for the Rapid Viral Response at Week 4(RVR4) Population.|The outcome is a number of the patients with an undetectable Hepatitis C Virus (HCV) RNA at week 4 that have an undetectable HCV RNA 12 weeks after end of treatment.|12 weeks|41 patients had a RVR4|||participants|||Number
2625438|NCT01912404|Primary|Survival||28 days|The study was prematurely stopped due to emerging data from another study showing ~10 to 12-fold higher exposures in patients with severe hepatic impairment compared to those with normal liver function. Since subjects with alcoholic hepatitis would likely have severe hepatic impairment, the study was stopped and survival data was not collected.||||||
2625439|NCT01912352|Secondary|Clinical Global Impression-Improvement Scale at 8 Weeks|"Clinical Global Impression-Improvement (CGI-I) scale is a one-item measure evaluating the change from the initiation of treatment on a seven-point scale: Compared to the patient's condition at baseline [prior to medication initiation], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.~Clinical Global Impression-Improvement was measured at 8 weeks."|baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2625440|NCT01912352|Primary|Change From Baseline ADHD Rating Scale-IV Scores at 8 Weeks|"Attendtion-deficit hyperactivity disorder (ADHD) Rating Scale-IV is the sum of 18 questions, ranging from 0 (no symptoms) to 54 (worst possible symptoms).~Change from baseline ADHD Rating Scale-IV scores at 8 weeks was calculated as baseline minus 8 weeks."|baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2625441|NCT01912339|Secondary|Responders at 12 Months|Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 12 months compared to baseline.|12 Months|Intention to Treat population (ITT) for treatment subjects only. Control subjects randomized follow-up concluded at 3 months.|||Participants|||Number
2625442|NCT01912339|Secondary|Responders at 6 Months|Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 6 months compared to baseline.|6 Months|Intention to Treat population (ITT) for treatment subjects only. Control subjects randomized follow-up concluded at 3 months.|||Participants|||Number
2625443|NCT01912339|Secondary|Responders at 3 Months|Number of subjects with a greater than or equal to 30% improvement (reduction) in the International Prostate Symptom score (IPSS) at 3 months compared to baseline.|3 Months|Intention to Treat population (ITT)|||Participants|||Number
2625444|NCT01912339|Primary|Safety: Device Related Serious Complications|"This safety endpoint will be to demonstrate that the composite observed rate of post-procedure device related serious complications in the Treatment Arm are is less than or equal to 12% at 3 months.~Composite device related serious complications for this endpoint are 1) De Novo (new) severe urinary retention lasting more than 21 consecutive days post treatment, 2) Device related formation of fistula between the rectum and urethra, and 3) device perforation of the rectum or GI tract. Twelve percent was a pre-specified performance goal for the safety endpoint."|3 Months|Intention to Treat population (ITT) for treatment arm subjects only. Control subjects did not undergo a treatment procedure so they were not assessed for this endpoint.|||Participants||95% Confidence Interval|Number
2625445|NCT01912339|Primary|Efficacy: Change From Baseline in the International Prostate Symptom Score (IPSS) at 3 Month Follow-Up|Comparison of the change in BPH symptoms as measured by IPSS change between the Treatment and Control arm at 3 months post-treatment. The IPSS is a well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH Symptoms. The first seven questions of the IPSS Questionnaire address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency each on a scale of 0 to 5. The total score, summed across the seven items measured, ranges from 0 (no symptoms) to 35 (most severe symptoms).|3 Month Follow-up Visit|Intention to Treat population (ITT)|||Cange in IPSS score||95% Confidence Interval|Mean
2625446|NCT01912222|Primary|Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).|Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles)|The safety analysis population was defined as participants who received at least 1 dose of ixazomib.|||participants|||Number
2625447|NCT01912222|Primary|Number of Participants Reporting Clinically Significant Change From Baseline in Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.|Baseline up to Day 15 for each treatment cycle (28 days treatment cycle for up to a maximum of 12 cycles)|The safety analysis population was defined as participants who received at least 1 dose of ixazomib.|||participants|||Number
2625448|NCT01912222|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 30 days after last dose of study drug (Day 45 for each treatment cycle for up to a maximum of 12 cycles [28 days treatment cycles])|The safety analysis population was defined as participants who received at least 1 dose of ixazomib.|||participants|||Number
2625449|NCT01912222|Primary|Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib||Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose|The PK analysis population was defined as participants who received the single dose of ixazomib in Part A of the study, did not receive any excluded concomitant medications through the completion of PK sampling, and had sufficient concentration-time data to permit the reliable estimation of PK parameters by noncompartmental analysis methods.|||hours||Full Range|Median
2625450|NCT01912222|Primary|Unbound Cmax: Unbound Maximum Observed Plasma Concentration for Ixazomib||Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose|The PK analysis population was defined as participants who received the single dose of ixazomib in Part A of the study, did not receive any excluded concomitant medications through the completion of PK sampling, and had sufficient concentration-time data to permit the reliable estimation of PK parameters by noncompartmental analysis methods.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2625451|NCT01912222|Primary|Unbound AUC(0-last): Unbound Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib||Part A, Day 1: Pre-dose and at multiple timepoints (up to 336 hours) post-dose|The PK analysis population was defined as participants who received the single dose of ixazomib in Part A of the study, did not receive any excluded concomitant medications through the completion of PK sampling, and had sufficient concentration-time data to permit the reliable estimation of PK parameters by noncompartmental analysis methods.|||nanogram*hours per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2625452|NCT01911845|Secondary|Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin|Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Minimum plasma concentration (C trough; measured in ng/mL) was directly determined from the concentration-time data.|Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose|Participants who consented for intensive pharmacokinetic blood sampling|||ng/mL||Standard Deviation|Mean
2625453|NCT01911845|Secondary|Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin|Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. The time to maximum plasma concentration (Tmax; measured in hours) was directly determined from the concentration-time data.|Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose|Participants who consented for intensive pharmacokinetic blood sampling|||hours||Standard Deviation|Mean
2625454|NCT01911845|Secondary|Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin|Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and were analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Maximum plasma concentration (Cmax; measured in ng/mL) was directly determined from the concentration-time data.|Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose|Participants who consented for intensive pharmacokinetic blood sampling|||ng/mL||Standard Deviation|Mean
2625455|NCT01911845|Secondary|Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin|Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and were analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Area under the plasma concentration-time curve from time 0 to 24 hours (AUC24 in ng*hr/mL)] was estimated using noncompartmental analyses. For ABT-450, ritonavir, and ABT-267, the AUC from time 0 to the last measureable concentration (AUCt in ng*hr/mL) was calculated instead of AUC24 due to time deviations at 24 hours. The AUCt values are approximately equivalent to AUC24. For ABT-333, ABT-333 M1, and RBV, the AUC from time 0 to 12 hours (AUC12 in ng*hr/mL) after the morning dose was calculated using the 24-hour concentration as the 12-hour concentration as dosing was twice a day and a 12-hour sample was not collected in this study.|Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose|Participants who consented for intensive pharmacokinetic blood sampling|||ng*hr/mL||Standard Deviation|Mean
2625456|NCT01911845|Secondary|Percentage of Participants With Virologic Relapse Post-treatment|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment. Completion of treatment was defined as a study drug duration ≥ 77 days.|From the end of treatment through 12 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment.|||Percentage of participants|||Number
2625457|NCT01911845|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment) or fail to suppress (HCV RNA ≥ LLOQ) persistently during treatment with at least 6 weeks [≥ 36 days] of treatment.|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12|All enrolled participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2625458|NCT01911845|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantification [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All enrolled participants who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2625459|NCT01911819|Secondary|The Percentage of Non-vital Bone/Residual Bone Graft Material in a Bone.|Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis.|24months||||percentage of residual bone materials|Maxillary Sinuses|Standard Deviation|Mean
2625460|NCT01911819|Primary|The Percentage of Vital Bone in a Total Amount of a Bone Specimen|Bone biopsy was taken in a mean of 9.1 months after sinus graft procedure from previous lateral window of maxillary sinus. The bone cores were analyzed though histomorphometric analysis.|24months||||percentage of vital bone|Maxillary sinuses|Standard Deviation|Mean
2625461|NCT01911793|Secondary|Diagnosis of Postoperative Ileus|diagnosis of postoperative ileus or bowel obstruction made by attending surgeon based on clinical data including abdominal distention, nausea/vomiting, decreased stom output and radiologic factors|30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.||||||
2625462|NCT01911793|Secondary|Episodes of Vomiting|any episodes of vomiting will be recorded|during postoperative hospital admission (30 day period)|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.||||||
2625463|NCT01911793|Secondary|Any Insertion of Nasogastric Tube|insertion of nasogastric tube after surgery will be recorded|30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.||||||
2625464|NCT01911793|Secondary|Major and Minor Medical and Surgical Complications|any major or minor medical and surgical complications after surgery will be recorded|30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.||||||
2625465|NCT01911793|Secondary|Time to Discharge Based on GI Function|postoperative day which patient is considered ready for discharge based solely on Gastrointestinal function|30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.||||||
2625466|NCT01911793|Secondary|Hospital Discharge|postoperative day after surgery which patient was discharged home|30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.||||||
2625467|NCT01911793|Secondary|Time to Passage of Stool|# of hours after surgery until the patient passes stool into stoma bag|during 30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.||||||
2625468|NCT01911793|Secondary|Time to Flatus (Passing Gas Into Stoma Bag)|# of hours after surgery at which point first passage of flatus (gas) into stoma bag|during 30 day postoperative period|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.||||||
2625469|NCT01911793|Primary|Tolerating Low Residue Diet|% of patients tolerating a low residue diet on postoperative day 3 will be assessed|by postoperative day 3( 3rd day after surgery)|Data were not collected and no data was analyzed study was terminated due to issues with study enrollment and study administrative coverage.||||||
2625487|NCT01911442|Secondary|Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) Modified for Pervasive Developmental Disorders (PDDs)|CY-BOCS total score ranges from 0 to 20. The higher value of CY-BOCS scores the greater severity of illness. This table is a summary of Y-BOCS compulsion total score.|6 Weeks|ITT|||units on a scale||Standard Error|Least Squares Mean
2625470|NCT01911780|Secondary|Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the Extension Period.|"Change from baseline in mean seated systolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.~The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'."|Reference baseline (week 0) and week 60 (end of extension period)|FASEX (OC)|||mmHg||Standard Error|Mean
2625471|NCT01911780|Secondary|Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the Extension Period.|"Change from baseline in mean seated diastolic blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.~The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'."|Reference baseline (week 0) and week 60 (end of extension period)|FAS in the extension period (FASEX OC) was defined as a collection of patients i) included in the FAS; ii) taking at least 1 dose of T80/A5/H12.5 mg in the extension period; and iii) taking measurements of seated DBP at reference baseline and at 1 or more time points in the extension period.|||mmHg||Standard Error|Mean
2625472|NCT01911780|Secondary|The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks of Extension Period.|"The number of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 52 weeks of the extension period. Note, week 52 of the extension period corresponds to 60 weeks after the reference baseline.~The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'."|Reference baseline (week 0) and week 60 (end of extension period)|FAS|||Participants|||Number
2625473|NCT01911780|Secondary|The Percentage of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 8 Weeks of Double-blind Period.|The percentage of patients with DBP<90 mmHg and SBP<140 mmHg as seated blood pressure at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.|Double-blind and 8 weeks|FAS|||Participants||95% Confidence Interval|Number
2625474|NCT01911780|Secondary|Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.|Change from baseline in mean seated systolic blood pressure (SBP) at trough after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.|baseline and 8 weeks|FAS|||mmHg||Standard Error|Mean
2625475|NCT01911780|Primary|Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.|Change from baseline in mean seated diastolic blood pressure (DBP) at trough (24-hour post dosing) after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.|baseline and 8 weeks|Full analysis set (FAS) was, conforming to the intent-to-treat principle, defined as all patients i) included in the treated set; and ii) taking measurements of seated DBP at reference baseline and at 1 or more time points during the double-blind period|||mmHg||Standard Error|Mean
2625476|NCT01911689|Secondary|The Relationship Between the T2* Value and the Severity of AP According to Apache II|In clinical practice, the physician usually used the APACHE II to evaluate the severity of acute pancreatitis. AP was graded as mild (0-7 points) and severe AP (≥8 points) according to the APACHE II scoring system.|1 year|Indengpent T test|||ms||Standard Deviation|Mean
2625477|NCT01911689|Secondary|The T2* Value in Different Severity of AP According to MRSI|AP was graded as mild (0-3 points), moderate (4-6 points) or severe (7-10 points), according to the MR-severity index (MRSI) which was derived from the CT-severity index .|1 year|AP was graded as mild (0-3 points), moderate (4-6 points) or severe (7-10 points), according to the MR-severity index (MRSI) which was derived from the CT-severity index .|||ms||Standard Deviation|Mean
2625478|NCT01911689|Secondary|The Difference of T2* Value Between the Edematous AP and Necrotizing AP|Compare the difference of the T2* value between the edematous AP group and necrotizing AP group|1 year|compare the difference of T2* value between the edematous AP and necrotizing AP|||ms||Standard Deviation|Mean
2625479|NCT01911689|Primary|The T2* Values in the Diagnosis of AP|Compare the difference of the T2* value between the AP group and the control group.|1 year|compare T2* value between the AP group and the control group using independent sample t test|||ms||Standard Deviation|Mean
2625480|NCT01911546|Secondary|Incidence of Cell Mediated Rejection (CMR)|Patients will be monitored for any episodes of CMR.|6 months||||Participants|||Count of Participants
2625481|NCT01911546|Primary|Incidence of Antibody Mediated Rejection (ABMR)|Protocol biopsies were obtained at T0 and 6 months post transplant.|6 months||||Participants|||Count of Participants
2625482|NCT01911546|Primary|The Number of CMV Viremia|The number of patients with CMV viremia|12 Months||||Participants|||Count of Participants
2625483|NCT01911546|Primary|The Number of Polyoma BK Viremia Patients|Patients will be monitored at regular interval for the development of Polyomavirus Viremia.|12 months||||Participants|||Count of Participants
2625484|NCT01911442|Secondary|Proportion of Subjects Who Have at Least 25% Reduction From Baseline to Week 6 in the ABC Irritability Subscale Score.||6 Weeks|ITT|||percentage of subjects|||Number
2625485|NCT01911442|Secondary|Proportion of Subjects Who Have CGI-I Score of 1 (Very Much Improved) or 2 (Much Improved) at Week 6||6 Weeks|ITT - the current data presented is at week 6.|||percentage of subjects|||Number
2625486|NCT01911442|Secondary|Change From Baseline in the Caregiver Strain Questionnaire (CGSQ)|CGSQ is a caregiver reported assessment to assesses extent to which caregivers are affected by special demands associated with caring for a child with emotional/behavioral problems. CGSQ is comprised of three subscales which range in severity from 1 to 5 (Objective Strain, Subjective Externalized Strain, Subjective Internalized Strain), The 3 subscales are calculated as the averages of the corresponding individual items. Higher scores on each indicates greater strain. A Global Strain score is calculated by summing the three subscales (Objective Strain, Subjective Externalized Strain, Subjective Internalized Strain) to provide an indication of the total impact of the special demands on the family. Global Strain scores range from 3 to 15. As with the individual subscales, higher scores indicate greater strain.|6 Weeks|ITT|||units on a scale||Standard Error|Least Squares Mean
2625488|NCT01911442|Secondary|Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity Subscale Score at Week 6|The ABC hyperactivity and noncompliance subscale score is the sum of 16 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC hyperactivity and noncompliance subscale score may range from 0 to 48. In general, higher values of ABC subscale scores represent greater severity of illness.|Baseline to 6 Weeks|ITT|||units on a scale||Standard Error|Least Squares Mean
2625489|NCT01911442|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 6|The Clinical Global Impression - Severity of Illness (CGI-S) Scale is rated on a 7-point scale of severity with 1 = Normal, not at all ill to 7 = Among the most extremely ill patients. Higher values of CGI-S scores represent greater severity of illness.|Baseline to 6 Weeks|Intent to treat population. 49 in the placebo arm is correct. One subject in the placebo group did not receive the study medication, and therefore that subject was removed from the ITT population. A total of 50 subjects were randomized and 49 subjects were included in the placebo group of the ITT population.|||units on a scale||Standard Error|Least Squares Mean
2625490|NCT01911442|Primary|Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6|The ABC irritability subscale score is the sum of 15 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC irritability subscale score ranges from 0 to 45. Higher values of ABC subscale scores represent greater severity of illness.|Baseline to 6 Weeks|Intent to treat (ITT) population includes all randomized subjects who receive at least one dose of study medication and have at least one post-baseline assessment in any efficacy variable.|||units on a scale||Standard Error|Least Squares Mean
2625491|NCT01911429|Secondary|Change From Baseline in PANSS Excitability Subscale Scores|"Excitability subscale scores (range 4-28): consists of the following four items from the PANSS: excitement, hostility, uncooperativeness, and poor impulse control~Higher values of PANSS Excitability Subscale Score represent greater severity of illness~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction."|baseline, week 6|ITT population|||units on a scale||Standard Deviation|Mean
2625492|NCT01911429|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Scores|"PANSS general psychopathology subscale score: changes from baseline over time - mixed model for repeated measures -- General psychopathology (range 16-112): sum of Items G1 to G16 in the general psychopathology subscale -Higher values of PANSS General Psychopathology Subscale Score represent greater severity of illness~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction."|baseline, week 6|ITT population|||units on a scale||Standard Deviation|Mean
2625493|NCT01911429|Secondary|Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS)|"Clinician-rated Children's Global Assessment Scale (CGAS) score: summary statistics over time - CGAS is a numeric scale (1 through 100) , where 1 represents the most impaired functioning and 100, superior functioning~LS Mean and SE for change from baseline are from an ANCOVA model including factors of treatment, pooled country and age group (stratification factor), and corresponding Baseline score as covariate and LOCF approach."|baseline, week 6|ITT population|||units on a scale||Standard Deviation|Mean
2625494|NCT01911429|Secondary|Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q)|"PQ-LES-Q percentage maximum possible score: summary statistics over time - PQ-LES-Q % maximum possible score can range from 0% to 100%. Higher scores indicate better quality of life.~LS Mean and SE for change from baseline are from an ANCOVA model including factors of treatment, pooled country and age group (stratification factor), and corresponding Baseline score as covariate and LOCF approach."|baseline, week 6|ITT population|||units on a scale||Standard Deviation|Mean
2625495|NCT01911429|Secondary|Proportion of Responders, Where Response is Based on ≥ 20% Improvement From Baseline in PANSS Total Score at Week 6|PANSS responder analysis over time: achieving >= 20% reduction from baseline|week 6|ITT Population|||number of participants|||Number
2625496|NCT01911429|Secondary|Change From Baseline in PANSS Positive, Negative Subscale Scores|"PANSS Negative subscale score: changes form baseline over time - Mixed model for repeated measures - - Negative subscale (range 7-49): sum of Items N1 to N7 in the negative subscale - Higher values of PANSS Negative Subscale Score represent greater severity of illness~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction."|baseline, week 6|ITT population|||units on a scale||Standard Deviation|Mean
2625497|NCT01911429|Secondary|Change From Baseline in PANSS Positive Subscale Scores|"PANSS positive subscale score: changes from baseline over time - mixed model for repeated measures -Positive subscale (range 7-49): sum of Items P1 to P7 in the positive subscale - Higher values of PANSS Positive Subscale Score represent greater severity of illness~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, corresponding PANSS subscale score at baseline, and treatment-by-visit interaction."|baseline, week 6|ITT population|||units on a scale||Standard Deviation|Mean
2625498|NCT01911429|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale|"Clinical Global Impression severity (CGI-S): Changes from baseline over time-mixed model for repeated measures- scale from 1-7 - 1=normal, not at all ill; 7=among the most extremely ill patients.~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, CGIS at baseline, and treatment-by-visit interaction."|baseline, week 6|The ITT population includes all randomized subjects who receive at least one dose of study medication and have at least one post-baseline assessment in any efficacy variable|||units on a scale||Standard Deviation|Mean
2625538|NCT01911221|Primary|Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule|The immunogenicity was assessed to evaluate the human serum bactericidal activity (hSBA) against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and M10713 strain at baseline and at one month after the second vaccination.|Day1 and Day 91|Analysis was done on Full Analysis Set|||Titers||95% Confidence Interval|Geometric Mean
2625499|NCT01911429|Primary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6.|"PANNS total score: Changes from baseline over time - mixed model for repeated measures at week 6 -PANSS total score may range from 30 to 210- Higher values of PANSS total score represent greater severity of illness~LS Mean and SE for change from baseline are based on Mixed Model for Repeated Measures with fixed effects terms for treatment, visit (as a categorical variable), pooled country, age strata, PANSS total score at baseline, and treatment-by-visit interaction."|Baseline to 6 weeks|The ITT population includes all randomized subjects who receive at least one dose of study medication and have at least one post-baseline assessment in any efficacy variable.|||units on a scale||Standard Deviation|Mean
2625500|NCT01911403|Secondary|Percentage of Patients With Angio-Seal™ Deployment Success|"According the physician criteria, it will be YES If the anchor was deliver properly, the absorbable component remain in the correct point of the arterial puncture and no bleeding in the skin puncture."|At puncture closure|Only patients in the Angio-Seal arm is analyzed|||percentage of patients|||Number
2625501|NCT01911403|Secondary|Time to Discharge From Interventional Radiology Department|Time that the physician grants the patient the discharge order from the Radiology Department. If the patients has order to be hospitalized up to 24h after the puncture closure by the radiologist, then, the discharge from the radiology department will be 24h, even if the patient needs to continue hospitalized in other department.|At discharge||||hours||Standard Deviation|Mean
2625502|NCT01911403|Secondary|Number of Patients With Time to Hemostasis Between 4-60 Minutes|"Time to hemostasis is the time from the beginning of closure procedure, until the physician take away their hands from the patient, regardless the closure procedure, and confirm the stop of bleeding."|At puncture closure||||participants|||Number
2625503|NCT01911403|Secondary|Number of Patients With Time to Hemostasis Between 0-4 Minutes|"Time to hemostasis is the time from the beginning of closure procedure, until the physician take away their hands from the patient, regardless the closure procedure, and confirm the stop of bleeding."|At puncture closure||||participants|||Number
2625504|NCT01911403|Secondary|Number of Patients With Any Complications|"Number of patients with any complications since the puncture closure until 2 weeks ± 1 week.~The complications are related to the puncture closure evaluated at closure, discharge and follow-up. These include hematoma, Inferior limb ischemia, prolonged pain at puncture site, puncture site local infection, pseudoaneurysm, significant bleeding and vessel occlusion."|At puncture closure procedure, at discharge and at follow up (2 weeks+/-1 week)||||participants|||Number
2625505|NCT01911403|Secondary|Number of Patients With Mobilization Time Between 4-48 Hours|Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.|At discharge||||participants|||Number
2625506|NCT01911403|Primary|Number of Patients With Mobilization Time Between 0-4 Hours|Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.|At discharge||||participants|||Number
2625507|NCT01911390|Secondary|Palatability|Other outcomes include palatability and acceptability of study-provided snacks that include cooked navy bean powder, rice bran, or a combination in children. The participants will fill out questionaires describing how the products tasted and how much they consumed.|Baseline, 4 weeks|The criteria used to quantify GI discomforts or issues included participants who responded ‘yes’ to any GI discomfort and rated the discomfort level ≥3 out of a 5-point scale.|||Participants|||Count of Participants
2625508|NCT01911390|Primary|Total Cholesterol|The primary outcome variable to be studied is total cholesterol. A full lipid panel report will also provide information on LDL, HDL, triglycerides etc.|Baseline, 4 weeks||||mg/dL||Standard Deviation|Mean
2625509|NCT01911351|Other Pre-specified|Percentage of Providers Who Rated the Procedure as Being Successful|Survey collection of rating of success of the procedure by one provider. Answers were Strongly Agree, Agree, Neutral, Disagree and Strongly Disagree. The first two categories were combined.|measured at the end of each procedure, approximately 10 minutes after the completion of the procedure||||percentage of participants|||Number
2625510|NCT01911351|Other Pre-specified|Percentage of Parents Who Reported That Their Child Was Comfortable During the Procedure|"A parental survey was collected post-procedure regarding the overall comfort of the child during the procedure. Other questions included whether the procedure was successfully completed, if the procedure went better than expected, was the parent pleased with the medications used and whether the child tolerated the procedure. Answers were Strongly Agree, Agree, Neutral, Disagree and Strongly Disagree. We chose the question that asked whether the child was comfortable during the procedure as it was most relevant. The categories Strongly Agree and Agree were combined in both groups."|measured at the end of each procedure, approximately 10 minutes after the procedure is completed|In the Standard Management arm, 38/39 parents completed the survey|||percentage of participants|||Number
2625511|NCT01911351|Other Pre-specified|Length of the Procedure|Another outcome measure is to compare the change in length of the procedure with or without nitrous oxide intervention.|measure time duration of each procedure, average 5-15 minutes||||minutes||Inter-Quartile Range|Median
2625512|NCT01911351|Secondary|M-YPAS Anxiety Scale|Secondary outcome will be the Modified YALE Preoperative Anxiety Scale, measured pre-procedure, and intra-procedure. This is a validated scale measuring anxiety by assessment of Activity, Vocalization, Emotional Expressivity, State of Arousal and Use of Parents. All categories have a maximum score of 4 except for Vocalization with a maximum score of 6. The scores within each category are totaled and a total anxiety score is reported ranging from 5 (no anxiety) to 22 (highest level of anxiety).|measured pre-procedure at time provider explains procedure to the patient, and during procedure at peak pain time approximately 2-5 minutes into the procedure||||units on a scale||Inter-Quartile Range|Median
2625513|NCT01911351|Primary|FLACC Pain Scale|The primary outcome will be the FLACC (Face, Legs, Activity, Cry, Consolability) Pain scale measured intra-procedure. The scale measures facial expression, movement of legs, general activity, presence and quality of cry and the need and ability to be consoled. Scoring for each category ranges from 0 (no response to pain) to 2 (maximum response to pain). The scores are totaled and a total score ranging from 0-10 is reported.|peak pain during procedure approximately 2-5 minutes into the procedure||||units on a scale||Inter-Quartile Range|Median
2625514|NCT01911273|Secondary|Observed Serum Concentration of Circulating Protein||Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal.|FAS included all randomized participants regardless of what treatment, if any, was received.|||mcg/mL|||Number
2625515|NCT01911273|Secondary|Ratio to Baseline of Serum Circulating Protein Concentration|Protein involved TGFB1, VEGF-A, VEGF-C, PIGF, Endoglin, BMP-9, VEGFR1, VEGFR2, VEGFr3, Ang-2, VEGF-D, CD54, CD106, and CCL2. Tumor molecular characteristics including but not limited to transcriptomic (ribonucleic acid) signatures of efficacy.|Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal.|FAS included all randomized participants regardless of what treatment, if any, was received.|||Percentage|||Number
2625516|NCT01911273|Secondary|Presence of Sensitivity Signature|Tumor molecular characteristics including but not limited to transcriptomic (RNA) signatures of sensitivity|Cycle 1 Day 1 (before infusion), Cycle 4 Day 1 (before infusion), at disease progression/participant withdrawal.|FAS included all randomized participants regardless of what treatment, if any, was received.||||||
2625517|NCT01911273|Secondary|Number of Participants With Human Anti-Human Antibodies (HAHA)||Cycle 1, 2, 4, 6, 8 Day 1 at 0 hour (pre-dose)|The immunogenicity assessment consisted of all participants who had at least 1 sample on at least 1 day of immunogenicity assessment.|||Participants|||Number
2625518|NCT01911273|Secondary|Trough Serum Concentration of PF-03446962 (Ctrough)||0 hour (predose) on Day 1 of Cycles 1, 2, 4, 6, and 8|The PK concentration set consisted of all participants who were treated and had at least one concentration on at least 1 day of PK assessment.|||mcg/mL||Standard Error|Geometric Mean
2625519|NCT01911273|Secondary|Maximum Serum Concentration (Cmax)||1 hour (after start of infusion) on Day1 of Cycles 1, 2, 4, 6, and 8|The pharmacokinetic (PK) concentration set consisted of all participants who were treated and had at least one concentration on at least 1 day of PK assessment.|||microgram per milliliter (mcg/mL)||Standard Error|Geometric Mean
2625520|NCT01911273|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Hepatobiliary Questionnaire (FACT-Hep)|"Patient reported outcomes (PROs) were assessed using the FACT-Hep. The FACT-Hep included the FACT-general (FACT-G) and a hepatobiliary module, it consisted of the 27-item FACT-G, which assessed generic health-related quality of life (HRQoL) concerns, and the 18-item hepatobiliary subscale (HS), which assessed disease-specific issues. The questionnaire used a 5 point Likert scale from '0' not at all to '4' very much regarding how much each item was present in the last 7 days; lower score indicated severer symptom. Eight of the items (lack of energy, pain, weight loss, back pain, fatigue, stomach pain/discomfort, nausea, and jaundice) made up the Fact Hepatobiliary Symptom Index (FHSI 8) were considered to be symptoms specific to hepatobiliary cancer."|Screening, Cycle 1 Day1,8; Cycle >=2 Day1; End of treatment, survival follow-up up to 24 months after last participant randomization.|FAS included all randomized participants regardless of what treatment, if any, was received.|||Units on scale||Standard Deviation|Mean
2625521|NCT01911273|Secondary|Percentage of Participants With Disease Control Rate (DCR) at 16 Weeks|DCR was defined as the proportion of participants with confirmed CR or confirmed PR or a best response of stable disease (SD) >=16 weeks according to RECIST, relative to all randomized participants. CR was defined as disappearance of all target lesions. PR was defined as >=30% decrease in the sum of diameters of target lesions and non CR/non PD to non-target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.|From first randomization to date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization|FAS included all randomized participants regardless of what treatment, if any, was received.|||Percentage of Participants||95% Confidence Interval|Number
2625522|NCT01911273|Secondary|Duration of Response (DR)|DR was defined as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included >1 date, the first date was to be used. DR (in months) was calculated as the end date for DR minus date of first CR or PR that was subsequently confirmed plus 1 divided by 30.4. CR was defined as disappearance of all target lesions and non-target, if any. PR was defined as >=30% decrease in the sum of diameters of target lesions and non CR/non PD to non-target lesions.|From first randomization to date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization|Subgroup of participants with objective response. Since objective response was not assessed in any of the participants, ideally the number of participants analyzed field should be 0 and the reason was insufficient data available to conduct adequate analysis due to premature termination of the study.||||||
2625523|NCT01911273|Secondary|Objective Response Rate (ORR) - Percentage of Participants With Objective Response|ORR was defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1, relative to all randomized participants. CR were those that persisted on repeat imaging study more than or equal to (>=) 4 weeks after initial documentation of response. PR was defined as >=30% decrease in the sum of diameters of target lesions and non CR/non PD to non-target lesions. Participants who did not have on study radiographic tumor re-evaluation or who died, progressed or dropped out for any reason prior to reaching a CR or PR were to be counted as non-responders in the assessment of ORR. A participant who initially met the criteria for a PR and then subsequently became a confirmed CR, was to be assigned a best response of CR.|Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.|FAS included all randomized participants regardless of what treatment, if any, was received.|||Percentage of Participants|||Number
2625524|NCT01911273|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included >1 date, the first date was to be used. PFS (in months) was calculated as first event date minus first randomization date plus 1 divided by 30.4.|Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.|FAS included all randomized participants regardless of what treatment, if any, was received.|||Months||95% Confidence Interval|Median
2625525|NCT01911273|Primary|Overall Survival (OS)|OS was the duration from date of randomization to date of death due to any cause. For participants who are alive, overall survival was censored at the last contact. Death was determined from adverse event (AE) data where outcome was death or from follow-up contact data where the participant current status was death.|From first randomization to date of death from any cause, whichever came first, assessed up to 24 months after last participant randomization|Full analysis set (FAS) included all randomized participants regardless of what treatment, if any, was received.|||Months||95% Confidence Interval|Median
2625526|NCT01911273|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from first randomization to date of first documentation of objective tumor progression. If tumor progression data included more than (>) 1 date, the first date was to be used. TTP (in months) was calculated as first event date or last known progression-free date minus the first randomization date plus 1 divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1).|Screening and every 8 weeks by calendar thereafter, up to 24 months after last participant randomization.|FAS included all randomized participants regardless of what treatment, if any, was received.|||Months||95% Confidence Interval|Median
2625527|NCT01911260|Primary|Change in Height-for-Age Z-score (HAZ) From End of Supplementation to End of Follow-up Period.|"Schoolchildren were allocated into two homogeneous groups named Growth Deficit (HAZ < -1,5 Z-score), and Normal Height (HAZ between -1,0 and ±1,0 Z-score), and were randomly assigned to compose two exposed groups to receive a supplement of 30mg of zinc amino acid chelate, and two control groups to receive placebo individually once a week, during 12 weeks. Children's heights were measured at the End of Supplementation period and again after 12 weeks (Follow-up period). In combination with sex and age we transformed stature to Height-for-Age, expressed in Z-score, which was calculated as a number of standard deviations or Z-scores below or above the reference mean or median value, according to the formula below:~Z-score = (observed value - median value of the reference population) / standard deviation value of reference population.~We analyzed and discussed the change in HAZ (HAZ at the End of Follow-up period - HAZ at End of Supplementation)."|Height-for-Age Z-score was measured at the End of Supplementation period and again at the End of Follow-up period, with a 12 weeks interval.||||Z-Score||Standard Deviation|Mean
2625528|NCT01911221|Primary|Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination).|Safety was assessed as the number of subjects who reported Serious Adverse Events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, as collected from day 1 to day 91 following vaccination with rMenB+OMV NZ (a two dose schedule ) are reported.|Day 1 through Day 91 postvaccination.|Analysis was done on Unsolicited Safety Set.|||Number of subjects|||Number
2625529|NCT01911221|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination).|Safety was assessed as the number of subjects who reported unsolicited adverse events as collected from Day 1 to Day 91 following rMenB+OMV vaccination (a two dose schedule). Unsolicited adverse events were collected from day 1 through day 7 after each vaccination, while serious adverse events, medically attended adverse events and adverse events leading to withdrawal from study were reported from day 1 through day 91.|Day 1 through Day 91 postvaccination.|Analysis was done on Unsolicited Safety Set.|||Number of subjects|||Number
2625530|NCT01911221|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving rMenB+OMV NZ Vaccine ( After Any Vaccination)|The number of subjects with solicited local and systemic adverse events after receiving rMenB+OMV NZ (a two dose vaccination schedule) collected from day 1 through day 7 are reported.|Day 1 through Day 7 postvaccination.|Analysis was done on Solicited Safety Set.|||Number of Subjects|||Number
2625531|NCT01911221|Primary|Percentages of Subjects With Four Fold Increase From Baseline For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule.|The antibody responses were assessed to evaluate the four fold increases in ELISA concentrations as measured by ELISA to the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month the second vaccination over baseline.|Day 1 and Day 91|Analysis was done on Full Analysis Set.|||Percentage of Subjects||95% Confidence Interval|Number
2625532|NCT01911221|Primary|Geometric Mean Ratios For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule.|The antibody responses were assessed to evaluate the geometric mean ratios as measured by ELISA within the subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at one month after the second vaccination versus baseline.|Day 1 and Day 91|Analysis was done on Full Analysis Set.|||Ratio||95% Confidence Interval|Geometric Mean
2625533|NCT01911221|Primary|Geometric Mean Concentrations For Vaccine Antigen 287-953 Following A Two-dose Vaccination Schedule|The antibody responses were assessed to evaluate the geometric mean concentrations as measured by Enzyme Linked Immunosorbent Assay (ELISA) in terms of percentages of subjects for the vaccine antigen 287-953 following a two dose vaccination schedule with rMenB+OMV NZ vaccine at baseline and at one month the second vaccination.|Day 1 and Day 91|Analysis was done on Full Analysis Set.|||U/mL||95% Confidence Interval|Geometric Mean
2625534|NCT01911221|Primary|Percentages Of Subjects With Four-Fold Increase In Human Serum Bactericidal Activity From Baseline Against N Meningitidis Serogroup B Strains Following a Two Dose Vaccination Schedule.|The antibody responses were assessed to evaluate the four fold increase in human serum bactericidal activity titers in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.|Day 91|Analysis was done on Full Analysis Set.|||Percentage of subjects||95% Confidence Interval|Number
2625535|NCT01911221|Primary|Percentages Of Subjects With hSBA≥ 1:8 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.|The immunogenicity was assessed to evaluate the human serum bactericidal activity titers ≥ 1:8 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.|Day1 and Day91|Analysis was done on Full Analysis Set.|||Percentage of Subjects||95% Confidence Interval|Number
2625536|NCT01911221|Primary|Percentages Of Subjects With hSBA≥ 1:5 Titers Against N Meningitidis Serogroup B Strains Following Two-Dose Vaccination Schedule.|The immunogenicity was assessed to evaluate the hSBA titers ≥ 1:5 in terms of percentages of subjects against N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 following a two dose vaccination schedule with rMenB+OMV NZ vaccine.|Day1 and Day91|Analysis was done on Full Analysis Set.|||Percentages of subjects||95% Confidence Interval|Number
2625537|NCT01911221|Primary|Geometric Mean Ratios Against N Meningitidis Serogroup B Strains Following A Two-dose Vaccination Schedule|The immunogenicity was assessed to evaluate the hSBA in terms of geometric mean ratios within subjects against the indicator strains of N meningitidis serogroup B (H44/76, 5/99, NZ98/254) and strain M10713 at one month after the second vaccination versus baseline.|Day1 and Day 91|The analysis was done on the Full Analysis Set.|||ratio||95% Confidence Interval|Geometric Mean
2625540|NCT01911169|Primary|Change at Week 16 in % Flow Mediated Dilation in Those Who Did and Did Not Replete Vitamin D|Measures were be performed with a Phillips iU22 Ultrasound system and a L9-3 9 mHz probe in 2D mode by a single operator using EKG gating. Baseline measures of brachial artery diameter will be made after the 10 minutes of rest. The blood pressure cuff, placed on the ipsilateral forearm, was inflated to 50 mmHg above the patient's systolic blood pressure for five minutes and then released. Endothelium-dependent FMD was measured continuously during and for three minutes after cuff release. Subjects rested for 10 minutes. Then, endothelium-independent dilation was measured 3 minutes after administration of 0.4 mg of sublingual nitroglycerine. The outcome (%FMD) was the difference between the average endothelium dependent diameter after cuff deflation and the average baseline diameter. The absolute difference between the % FMD at baseline and 16 week follow up was reported.|from zero to sixteen weeks||||Absolute change in % FMD||Standard Deviation|Mean
2625541|NCT01911065|Other Pre-specified|Identify Predictors That Correlate With a Rapid and Diverse T Cell Response.|The investigators will use the frequency and TCR diversity of VZV-specific T cells on days 7 and 14 after vaccination as outcome variable and identify predictors that positively or negatively correlate with a rapid and diverse T cell response in the different age groups.|0 to 14 Days|||||||
2625542|NCT01911065|Secondary|Number of Participants With Related Adverse Events||0 to 35 Days||||Participants|||Count of Participants
2625543|NCT01911065|Primary|Number of Participants Who Received Zostavax Immunization or Had Natural Exposure to VZV||Day 0 to Day 35||||Participants|||Count of Participants
2625544|NCT01910831|Secondary|Investigator Global Assessment (IGA)|"To determine efficacy with respect to the IGA of improving the appearance of bruising and reducing the appearance of photoaging of the forearms and hands:~IGA:~0=No improvement~<25% improvement~25% to 50% improvement~51% to 75% improvement~>75% improvement"|12 Weeks|20 subjects were enrolled into the study in a 1:1 ratio (DerMend: Placebo Control). 40 arms were used in the final data analysis. After 84 days of treatment, there was no change in serious AEs, or any AEs. 40 arms were used in the final data analysis.|||units on a scale||Standard Deviation|Mean
2625545|NCT01910831|Primary|Reduction of Bruising|To determine the efficacy (measured at 12 weeks) of DerMend Moisturizing Bruise Formula in improving the appearance of bruising and reducing the appearance of photoaging of the forearms and hands in mature skin.|12 weeks|20 subjects were enrolled into the study in a 1:1 ratio (DerMend: Placebo Control). 40 arms were used in the final data analysis. After 84 days of treatment, there was no change in serious AEs, or any AEs. 40 arms were used in the final data analysis.|||cm squared||Standard Deviation|Mean
2625546|NCT01910792|Primary|# of Pts w/ Enhanced Vitamin D Status|Increase circulating 25(OH)D levels|Baseline, Months 1, 2, 3|Only 3 subjects in each Arm had a conclusive set of data eligible for analysis.|||Participants|||Count of Participants
2625547|NCT01910688|Secondary|Adverse Events|Adverse event profile: Relationship to study device : Definite, Probable, Possible|12 months||||number of events|||Number
2625548|NCT01910688|Secondary|Patient Tolerability|Patient tolerability of the procedure. Patient tolerability will be measured by assessing adverse events related to the device or procedure. The Investigator will assess each adverse event with respect to severity and relationship to the study device.|12 months||||number of events|||Number
2625549|NCT01910688|Secondary|Technical Feasibility: Percentage of Participants Who Completed RFA Treatment|Technical feasibility of applying RFA to gastric pouch and gastrojejunostomy. This will be assessed by asking the physician for feedback on ease of use, ease of intubation and extubation,did the physician achieve tissue contact in targeted areas, was targeted area successfully ablated.|Day 0, month 4, month 8|At 0 month, 25 received 1st RFA treatment; at 4 month, 22 received 2nd RFA treatment; at 8 month, 18 received RFA Treatment|||percentage of participants|||Number
2625550|NCT01910688|Primary|Excess Body Weight Loss After RFA Treatment|EBWL 12 months after enrollment|12 months||||percentage of EBWL||Standard Deviation|Mean
2625551|NCT01910636|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2625552|NCT01910636|Secondary|Percentage of Participants Experiencing Viral Breakthrough|Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values.|Up to 12 weeks|Full Analysis Set|||percentage of participants|||Number
2625553|NCT01910636|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
2625554|NCT01910636|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.|Up to 12 weeks|Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug|||percentage of participants|||Number
2625555|NCT01910636|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled, received at least 1 dose of study drug, and had chronic genotype 2 HCV infection.|||percentage of participants|||Number
2625556|NCT01910519|Primary|Measurement of Microneutralization (MN) Titers With Influenza A Vaccine With and Without AS03 Adjuvant|To measure selective adaptive immune response; 21 days post second vaccination|Day 42||||IU/ml||95% Confidence Interval|Mean
2625557|NCT01910519|Primary|Measurement of Hemagglutination Inhibition Assay (HAI) Titers With Influenza A Vaccine With and Without AS03 Adjuvant|To measure selective adaptive immune response; 21 days post second vaccination|Day 42||||IU/ml||95% Confidence Interval|Mean
2625558|NCT01910519|Primary|Measurement of Microneutralization (MN) Titers With Influenza A Vaccine With and Without AS03 Adjuvant|To measure selective adaptive immune response; 21 days post first vaccination|Day 21||||IU/ml||95% Confidence Interval|Mean
2625559|NCT01910519|Primary|Measurement of Hemagglutination Inhibition Assay (HAI) Titers With Influenza A Vaccine With and Without AS03 Adjuvant|To measure selective adaptive immune response; 21 days post first vaccination|Day 21||||IU/ml||95% Confidence Interval|Mean
2625560|NCT01910519|Primary|Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant|To identify innate immune signatures; 7 days post second vaccination|Day 28||||differentially expressed genes (DEGs)|||Number
2625561|NCT01910519|Primary|Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant|To identify innate immune signatures; 3 days post second vaccination|Day 24||||differentially expressed genes (DEGs)|||Number
2625562|NCT01910519|Primary|Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant|To identify innate immune signatures; 1 day post second vaccination|Day 22||||differentially expressed genes (DEGs)|||Number
2625563|NCT01910519|Primary|Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant|To identify innate immune signatures; 7 days post first vaccination|Day 7||||differentially expressed genes (DEGs)|||Number
2625564|NCT01910519|Primary|Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant|To identify innate immune signatures; 3 days post first vaccination|Day 3||||differentially expressed genes (DEGs)|||Number
2625565|NCT01910519|Primary|Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant|To identify innate immune signatures; 1 day post first vaccination|Day 1||||differentially expressed genes (DEGs)|||Number
2625566|NCT01910441|Primary|Mean Amplitude of Glycemic Excursions (MAGE)||16 weeks|The study was prematurely terminated due to the unavailability of CGMS required for the assessment of the primary end point. The non-availability of CGMS severely affected participant recruitment. The primary outcome was not analyzed.||||||
2625567|NCT01910402|Secondary|Number of Participants With Treatment Emergent Resistances|Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to INI, NNRTI, NRTI, PI will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITT-E population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.|Up to week 48|On-treatment Genotypic Resistance Population|||Participants|||Number
2625568|NCT01910402|Secondary|Number of Participants With Post-Baseline HIV-1 Disease Progression|Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|Up to week 48|ITT-E Population, only those participants who experienced a disease progression to CDC Class C or death were analyzed.|||Participants|||Number
2625569|NCT01910402|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups|Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA (BPHR), Baseline CD4+ cell count (BCCC), Baseline Centers for Disease Control and Prevention (CDC) category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =<vs. >100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|Week 48|ITT-E Population|||Percentage of participants|||Number
2625570|NCT01910402|Secondary|Assessment of HIVTSQs Total Score at Indicated Timepoints.|The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Week 4, 12, 24, 48|ITT-E Population|||Score on a scale||Standard Deviation|Mean
2625571|NCT01910402|Secondary|Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS|The SF-12 is the 12 item abbreviated form of SF-36 survey. It provides information about how participants feel, and how well they have been able to perform their usual activities. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health . Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Baseline and Week 48|ITT-E Population|||Score on a scale||Standard Deviation|Mean
2625611|NCT01910389|Primary|Composite Outcome of Cardiovascular (CV) Mortality or Heart Failure (HF) Hospitalization||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.||||||
2625572|NCT01910402|Secondary|Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline|Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analysed based on log transformed data. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed. Estimates of adjusted mean and difference were calculated from an ANCOVA model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC.|Baseline, Weeks 24, 48|Safety Population.|||Ratio||95% Confidence Interval|Number
2625573|NCT01910402|Secondary|Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48|Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D and vitamin D2 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Baseline, Weeks 24, 48|Safety Population|||Nanomoles per liter||Standard Deviation|Mean
2625574|NCT01910402|Secondary|Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints|Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Baseline, Week 24, 48|Safety Population|||Nanograms per liter||Standard Deviation|Mean
2625575|NCT01910402|Secondary|Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints|Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.|Baseline, Week 24, 48|Safety Population|||Micrograms per liter||Standard Deviation|Mean
2625576|NCT01910402|Secondary|Number of Participants Who Withdrew From Treatment Due to AEs|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.|average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC|Safety Population|||Participants|||Number
2625577|NCT01910402|Secondary|Summary of Maximum Post-Baseline Emergent Hematology Toxicities|Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and until the follow up contact. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.|Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC|Safety Population|||Participants|||Number
2625578|NCT01910402|Secondary|Summary of Maximum Post-Baseline Emergent Chemistry Toxicities|Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and until the follow up contact. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.|Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC|Safety Population|||Participants|||Number
2625579|NCT01910402|Secondary|Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.|From start of IP through the Study Phase (Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC)|Safety Population|||Participants|||Number
2625580|NCT01910402|Secondary|Summary of AEs by Maximum Toxicity as Per DAIDS AE Grading Table.|Number of participants with Grade 1-4 AEs were assessed from the start of study treatment and until end of the Randimization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.|Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC|Safety Population|||Participants|||Number
2625607|NCT01910389|Secondary|Composite Outcome of All-cause Mortality or CV Hospitalization (Myocardial Infarction, Acute Coronary Syndrome, Stroke, Arrhythmia, or Heart Failure)||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.||||||
2625581|NCT01910402|Secondary|Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points|Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed.|Baseline, Week 24, Week 48|Safety Population|||milligrams per millimole||Standard Deviation|Mean
2625582|NCT01910402|Secondary|Change From Baseline in TC/HDL Ratio at Week 48|Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Subjects on lipid lowering therapy at baseline were excluded from analysis. Measurements collected after a subject initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.|Baseline and Week 48|Safety Population. Subjects on lipid lowering therapy at baseline were excluded from analysis.|||Ratio||Standard Error|Least Squares Mean
2625583|NCT01910402|Secondary|Change From Baseline in Triglycerides at Week 48|Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Subjects on lipid lowering therapy at baseline were excluded from analysis. Measurements collected after a subject initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.|Baseline and Week 48|Safety Population. Subjects on lipid lowering therapy at baseline were excluded from analysis.|||Millimoles per liter||Standard Error|Least Squares Mean
2625584|NCT01910402|Secondary|Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points.|Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||Femtoliter||Standard Deviation|Mean
2625585|NCT01910402|Secondary|Change From Baseline in Hematocrit Count at Indicated Time Points.|Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||Fraction of 1||Standard Deviation|Mean
2625586|NCT01910402|Secondary|Change From Baseline in Erythrocytes at Indicated Time Points.|Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||10^12 per liter||Standard Deviation|Mean
2625587|NCT01910402|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points|Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||10^9 cells per liter||Standard Deviation|Mean
2625588|NCT01910402|Secondary|Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints.|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||Ratio||Standard Deviation|Mean
2625589|NCT01910402|Secondary|Change From Baseline in Lipase at Indicated Timepoints.|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||Units per liter||Standard Deviation|Mean
2625590|NCT01910402|Secondary|Change From Baseline in Creatinine Clearance at Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||Milliliter per minute||Standard Deviation|Mean
2625608|NCT01910389|Secondary|All-cause Mortality||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.||||||
2625591|NCT01910402|Secondary|Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||International units per liter||Standard Deviation|Mean
2625592|NCT01910402|Secondary|Change From Baseline in Albumin at Indicated Timepoints.|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||Grams per liter||Standard Deviation|Mean
2625593|NCT01910402|Secondary|Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints.|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|Safety Population|||Micromoles per liter||Standard Deviation|Mean
2625594|NCT01910402|Secondary|Change From Baseline in Carbon Dioxide, Electrolytes, Lipids, Glucose, Urea at Indicated Time Points|Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol [CHLS], high density lipoprotein [HDL] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 4, 12, 24, 36, 48|"Safety Population. A value of 99999 indicates where no data is available or not able to determine the value."|||Millimoles per liter||Standard Deviation|Mean
2625595|NCT01910402|Secondary|Change From Baseline in CD4+ Cell Count at Indicated Timepoints|Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48|ITT-E Population|||Cells per millimeter cube||Standard Deviation|Mean
2625596|NCT01910402|Secondary|Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points|Change from the Baseline in plasma HIV-1 RNA were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48|ITT-E Population|||Log10 copies/mL||Standard Deviation|Mean
2625597|NCT01910402|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time|Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL were assessed at Baseline, Week 4, 12, 24 , 36 and Week 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value.|Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48|ITT-E Population|||Percentage of participants|||Number
2625598|NCT01910402|Primary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48|Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =<vs. >100,000 c/mL) and CD4+ cell count (=<350 cells per millimetre cube (cells/mm^3) or >350 cells/mm^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomised participants who received at least one dose of study medication.|Week 48|ITT-E Population|||Percentage of participants|||Number
2625599|NCT01910389|Secondary|Trend in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score From Baseline Through 18 Months||Randomization to 18 months|Trial was terminated early. Data for outcome not obtained.||||||
2625600|NCT01910389|Secondary|Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) Score From Baseline to 18 Months||Randomization to 18 months|Trial was terminated early. Data for outcome not obtained.||||||
2625601|NCT01910389|Secondary|Trend in 6 Minute Walk Distance From Baseline Through 18 Months||Randomization to 18 months|Trial was terminated early. Data for outcome not obtained.||||||
2625602|NCT01910389|Secondary|Change in 6 Minute Walk Distance From Baseline to 18 Months||Randomization to 18 months|Trial was terminated early. Data for outcome not obtained.||||||
2625603|NCT01910389|Secondary|Change in MLHFQ Score From Baseline to 3 Months||Randomization to 3 months|Trial was terminated early. Data for outcome not obtained.||||||
2625604|NCT01910389|Secondary|Change in 6 Minute Walk Distance From Baseline to 3 Months||Randomization to 3 months|Trial was terminated early. Data for outcome not obtained.||||||
2625605|NCT01910389|Secondary|Frequency of HF Hospitalizations||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.||||||
2625606|NCT01910389|Secondary|Frequency of CV Hospitalizations||Randomization through each subject's last semi-annual visit, up to a maximum of 3 years per subject|Trial was terminated early. Data for outcome not obtained.||||||
2625612|NCT01910311|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Baricitinib||Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Participants who received study drug (baricitinib in Period 1 and at least 1 dose of rifampicin and baricitinib in Period 2) and who had evaluable PK data.|||hours (h)||Full Range|Median
2625613|NCT01910311|Primary|PK: Area Under the Concentration Versus Time Curve From 0 to Infinity [AUC(0-∞)] of Baricitinib||Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Participants who received study drug (baricitinib in Period 1 and at least 1 dose of rifampicin and baricitinib in Period 2) and had evaluable PK data.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2625614|NCT01910311|Primary|PK: Maximum Concentration (Cmax) of Baricitinib||Period 1, Day 1 and Period 2, Day 10: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose|Participants who received study drug (baricitinib in Period 1 and at least 1 dose of rifampicin and baricitinib in Period 2) and had evaluable PK data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2625615|NCT01910298|Other Pre-specified|Time to Return to Work or Normal Daily Activities||6 and 12 months post-mastectomy and 24 month ppR|||||||
2625616|NCT01910298|Other Pre-specified|Healthcare Resource Use Including Length of Hospital Stay and Clinic Visits||At 6 and 12 months post-mastectomy and at 24 months ppR|||||||
2625617|NCT01910298|Other Pre-specified|Health-related Quality of Life||At 3, 6, and 12 months post-mastectomy and at 4 months ppR|||||||
2625618|NCT01910298|Secondary|Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast|Surgical interventions were all planned and unplanned post-mastectomy surgical interventions per participant on the reconstructed breast, within 24 months of the ISS, which is defined as the DTI breast reconstruction with Strattice™ TM or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction.|Within 24 months ppR|ppR Follow-up set included all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and completed 24 months ppR visit; whose 24-month visit was performed early due to termination of study were also included. Number analyzed is number of participants with data available at given time-point.|||interventions per participant||Standard Deviation|Mean
2625619|NCT01910298|Secondary|Number of Planned and Unplanned Post-mastectomy Surgical Interventions of the Reconstructed Breast Within 6 Months of ISS|ISS was defined as the DTI breast reconstruction with Strattice™ or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction. Postmastectomy surgical interventions on the reconstructed breast were reported for each participant and the total number of planned and unplanned post-mastectomy surgical interventions was averaged in each group.|Baseline up to 6 months post ISS|Safety set included all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and had their first surgery date recorded. Number analyzed is the number of participants with data available at the given time-point.|||interventions per participant||Standard Deviation|Mean
2625620|NCT01910298|Secondary|Aesthetic Outcomes of Participants Using Blinded Assessment 2D Photographs by Independent Review Panel||Baseline up to Month 24|The independent reviewer panel was not established and data were not collected due to early termination of the study, hence this endpoint could not be analyzed.||||||
2625621|NCT01910298|Secondary|Number of Participants With Clinically Significant Cases of Capsular Contracture as Defined by Baker Grade III or IV Within 24 Months of ppR|The surgeon assessed the level of capsular contracture in the participant's breast using the Baker Breast Contracture Scale where: Grade I=breast is normally soft and looks natural, Grade II=breast is a little firm but looks normal, Grade III=breast is firm and looks abnormal and Grade IV= breast is hard, painful, and looks abnormal. Baker Grade III and IV were defined as clinically significant and are reported here. Data is presented for number of participants with capsular contracture per breast (right breast and left breast).|Up to 24 months ppR|Safety set included all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and had their first surgery date recorded. Number analyzed for each category includes those participants for whom the Baker grade was assessed.|||participants|||Number
2625622|NCT01910298|Secondary|Number of Participants Experiencing One or More Serious BRRC Within 24 Months of Post-Permanent Reconstruction (ppR)|Serious BRRC were complications that required re-entry of the breast pocket with or without exchange or removal of the implant and any manipulation of the implant pocket including the IMF. Serious BRRC were detected through review by a medical monitor. BRRC were defined as: a) infection, local or systemic, b) hematoma, c) seroma, d) inflammation, e) skin or flap necrosis, f) capsular contraction as defined by Baker grade > 3, g) implant extrusion (loss or explants), and h) malposition, malrotation, asymmetry, and bottoming out.|Up to 24 months ppR|ppR Follow-up set consisted of all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and completed the 24 months ppR visit. Participants whose 24-month visit was performed early due to termination of the study were also included.|||Participants|||Count of Participants
2625623|NCT01910298|Secondary|Number of Participants Experiencing One or More Serious Breast Reconstruction-related Complications (BRRC)|Serious BRRC were complications that required re-entry of the breast pocket with or without exchange or removal of the implant and any manipulation of the implant pocket including the infra-mammary fold (IMF). Serious BRRC were detected through review by a medical monitor. Surgical complications included: capsular contracture (Baker grade ≥ 3), infection (local or systemic), hematoma, seroma, inflammation, skin or flap necrosis, implant extrusion, malposition, malrotation, asymmetry, bottoming out.|Up to 12 months post ISS|Post-ISS analysis set consisted of all participants who underwent a mastectomy followed by one of the two implant-based breast reconstruction methods and completed their first reconstruction surgery post-mastectomy and have a valid surgical assessment at least 337 days post ISS (12 month [365 days]-4 week [28 days] window).|||Participants|||Count of Participants
2625634|NCT01910181|Primary|Ctrough of RO5185426 on Day 21|Plasma PK samples were obtained from each participant, and the concentration immediately prior to drug administration was recorded. The value was averaged among all participants and expressed in μg/mL.|Pre-dose (0 hours) on Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||μg/mL||Standard Deviation|Mean
2625624|NCT01910298|Primary|Mean Number of Planned and Unplanned Post-mastectomy Surgical Interventions Per Participant on the Reconstructed Breast, Within 12 Months of the Initial Study Surgery (ISS)|ISS was defined as the DTI breast reconstruction with Strattice™ or the first surgery of the two-stage breast reconstruction. Data is presented for participants with unilateral (one breast) and bilateral (two breast) reconstruction. Postmastectomy surgical interventions on the reconstructed breast were reported for each participant and the total number of planned and unplanned post-mastectomy surgical interventions was averaged in each group.|Up to 12 months post ISS|Post-ISS analysis set consisted of all participants who underwent a mastectomy and completed their first reconstruction surgery post-mastectomy and have a valid surgical assessment at least 337 days post ISS (12 month [365 days]-4 week [28 days] window). Number analyzed is the number of participants with data available at the given time-point.|||interventions per participant||Standard Deviation|Mean
2625625|NCT01910181|Secondary|Overall Survival (OS)|OS was defined as the time from treatment start to death from any cause. Median time to event was estimated using Kaplan-Meier analysis, and the 95% CI was estimated using the Brookmeyer-Crowley method.|Throughout treatment (up to 16 months); survival followed every 3 months until discontinuation from study|Safety Population.|||months||95% Confidence Interval|Median
2625626|NCT01910181|Secondary|Percentage of Participants Who Died|The percentage of participants who died during the study was reported.|Throughout treatment (up to 16 months); survival followed every 3 months until discontinuation from study|Safety Population.|||percentage of participants|||Number
2625627|NCT01910181|Secondary|Progression-Free Survival (PFS)|Tumor response was evaluated using RECIST version 1.1 criteria. Disease progression was defined as ≥20% increase on-study in sum diameter of target lesions with absolute increase ≥5 mm, or the appearance of new lesion(s). PFS was defined as the time from treatment start to the first event of disease progression or death. Median time to event was estimated using Kaplan-Meier analysis, and the 95% CI was estimated using the Brookmeyer-Crowley method.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression; survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population.|||months||95% Confidence Interval|Median
2625628|NCT01910181|Secondary|Percentage of Participants With Death or Disease Progression According to RECIST Version 1.1|Tumor response was evaluated using RECIST version 1.1 criteria. Disease progression was defined as ≥20% increase on-study in sum diameter of target lesions with absolute increase ≥5 mm, or the appearance of new lesion(s). The percentage of participants with death or disease progression during the study was reported.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression; survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population.|||percentage of participants|||Number
2625629|NCT01910181|Secondary|Duration of Response According to RECIST Version 1.1|Tumor response was evaluated using RECIST version 1.1 criteria. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to <10 mm. PR was defined as ≥30) decrease from Baseline in sum diameter of target lesions. Disease progression was defined as ≥20% increase on-study in sum diameter of target lesions with absolute increase ≥5 mm, or the appearance of new lesion(s). Duration of response was defined as the time from initial response of CR or PR to the first event of disease progression or death. Median time to event was estimated using Kaplan-Meier analysis, and the 95% confidence interval (CI) was estimated using the Brookmeyer-Crowley method.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression; survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population; only participants with a previous response (assessment of CR or PR) were included.|||months||95% Confidence Interval|Median
2625630|NCT01910181|Secondary|Percentage of Participants With Disease Progression or Death Among Participants With a Previous Assessment of CR or PR According to RECIST Version 1.1|Tumor response was evaluated using RECIST version 1.1 criteria. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to <10 mm. PR was defined as ≥30) decrease from Baseline in sum diameter of target lesions. Disease progression was defined as ≥20% increase on-study in sum diameter of target lesions with absolute increase ≥5 mm, or the appearance of new lesion(s). The percentage of participants who died or progressed after CR or PR was reported.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression; survival followed every 3 months until discontinuation from study (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population; only participants with a previous response (assessment of CR or PR) were included.|||percentage of participants|||Number
2625631|NCT01910181|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Tumor response was evaluated using RECIST version 1.1 criteria. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to less than (<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease from Baseline in sum diameter of target lesions. The percentage of participants with a best overall response of CR or PR during the study was reported.|Tumor assessments at Screening, Day 1 of Cycle 3, and every two cycles (cycle length of 28 days) thereafter until disease progression (up to 16 months as of data cutoff 15-Dec-2014)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2625632|NCT01910181|Primary|Terminal Elimination Rate Constant (Kel) of RO5185426 on Day 21|Plasma PK samples were obtained from each participant and the kel was estimated. The value was averaged among all participants and expressed in inverse hours (h^-1).|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||hours^-1||Standard Deviation|Mean
2625633|NCT01910181|Primary|Accumulation Ratio of RO5185426 AUC From 0 to 8 Hours Between Day 21 and Day 1|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 8 hours, using the linear trapezoid rule. The AUC on Day 21 was divided by the AUC for Day 1. The resulting value was averaged among all participants and expressed as the accumulation ratio.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8 hours) on Days 1 and 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||accumulation ratio||Standard Deviation|Mean
2625635|NCT01910181|Primary|Ctrough of RO5185426 on Day 19|Plasma PK samples were obtained from each participant, and the concentration immediately prior to drug administration was recorded. The value was averaged among all participants and expressed in μg/mL.|Pre-dose (0 hours) on Day 19|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||μg/mL||Standard Deviation|Mean
2625636|NCT01910181|Primary|Trough Plasma Concentration (Ctrough) of RO5185426 on Day 15|Plasma PK samples were obtained from each participant, and the concentration immediately prior to drug administration was recorded. The value was averaged among all participants and expressed in μg/mL.|Pre-dose (0 hours) on Day 15|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||μg/mL||Standard Deviation|Mean
2625637|NCT01910181|Primary|Elimination Half-Life (t1/2) of RO5185426 Following Day 21 Dose|Plasma PK samples were obtained from each participant for calculation of t1/2, defined as the time elapsed for plasma concentrations to drop by half. The value was averaged among all participants and expressed in hours.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||hours||Standard Deviation|Mean
2625638|NCT01910181|Primary|AUC From 0 to 168 Hours of RO5185426 Following Day 21 Dose|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 168 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in h*μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||h*μg/mL||Standard Deviation|Mean
2625639|NCT01910181|Primary|Tmax of RO5185426 Following Day 21 Dose|Plasma PK samples were obtained from each participant, and the time of maximum post-dose concentration was recorded. The median value was derived from all participants and expressed in hours.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||hours||Full Range|Median
2625640|NCT01910181|Primary|Time of Maximum Plasma Concentration (Tmax) of RO5185426 on Day 1|Plasma PK samples were obtained from each participant, and the time of maximum post-dose concentration was recorded. The median value was derived from all participants and expressed in hours.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12 hours) on Day 1|PK Population.|||hours||Full Range|Median
2625641|NCT01910181|Primary|Cmax of RO5185426 Following Day 21 Dose|Plasma PK samples were obtained from each participant, and the maximum observed post-dose concentration was recorded. The value was averaged among all participants and expressed in μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12, 24, 28, 72, 76, 168 hours) from Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||μg/mL||Standard Deviation|Mean
2625642|NCT01910181|Primary|Maximum Plasma Concentration (Cmax) of RO5185426 on Day 1|Plasma PK samples were obtained from each participant, and the maximum observed post-dose concentration was recorded. The value was averaged among all participants and expressed in micrograms per milliliter (μg/mL).|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12 hours) on Day 1|PK Population.|||μg/mL||Standard Deviation|Mean
2625643|NCT01910181|Primary|AUC of RO5185426 From 0 to 12 Hours on Day 21|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 12 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in h*μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12 hours) on Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||h*μg/mL||Standard Deviation|Mean
2625644|NCT01910181|Primary|AUC of RO5185426 From 0 to 12 Hours on Day 1|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 12 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in h*μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8, 12 hours) on Day 1|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||h*μg/mL||Standard Deviation|Mean
2625645|NCT01910181|Primary|AUC of RO5185426 From 0 to 8 Hours on Day 21|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 8 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in h*μg/mL.|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8 hours) on Day 21|PK Population; only participants who provided sufficient data for the designated timeframe/visit were included.|||h*μg/mL||Standard Deviation|Mean
2625646|NCT01910181|Primary|Area Under the Plasma Concentration-Time Curve (AUC) of RO5185426 From 0 to 8 Hours on Day 1|Plasma PK samples were obtained from each participant for calculation of AUC from 0 to 8 hours, using the linear trapezoid rule. The value was averaged among all participants and expressed in hours by micrograms per milliliter (h*μg/mL).|Pre-dose (0 hours) and post-dose (1, 2, 4, 5, 8 hours) on Day 1|PK Population: All participants who provided evaluable data for PK analysis and did not have a significant protocol violation/deviation.|||h*μg/mL||Standard Deviation|Mean
2625647|NCT01910129|Secondary|Quality of Life in Epilepsy|"The Quality of Life in Epilepsy-31 (QOLIE-31) instrument is a self- administered questionnaire. It includes seven subscales: Overall Quality of Life, Seizure Worry, Emotional Well-Being, Energy/Fatigue, Cognitive, Medication Effects, and Social Function. Questions 1-30 can yield seven individual scores (per subtest) and a total (composite) score. Higher scores indicate better QOL with values ranging from 1 to 100.~Question 31 is a subjective assessment of one's general health condition.Higher scores indicate a better-reported general health condition with the range being 1-10.~Scores are presented at end of Intervention 1/Phase 2 (8 weeks) and at the end of Intervention 2/Phase 3 (8 weeks)."|16 weeks|"Safety population. 2 subject in the gammacore group and 1 subject in the sham group were missing data.~1 subject in the gammacore group was missing data in phase 3"|||units on a scale||Standard Deviation|Mean
2625648|NCT01910129|Secondary|Number of Seizure Free Days|The number of seizure-free days was collected from the subjects' diary. The total number of days observed days for each phase and the total number of seizure free days for each phase are presented for the course of the study throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).|16 weeks|"Safety population. 1 subject was missing data in the gammacore group.~1 subject from phase 2 gammacore group and 1 subject from the phase 2 sham group were missing data in phase 3"|||days|||Number
2625649|NCT01910129|Secondary|Type of Adverse Events|"Type of adverse events were split in to Adverse Events, Adverse Device Effects and Serious Adverse Events. Adverse events were reported throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).~For frequency see the Adverse Event Table."|16 weeks|Safety population.|||Participants|||Count of Participants
2625650|NCT01910129|Secondary|Severity of Seizure|"The Seizure Severity Questionnaire (SSQ) is a self-reported assessment tool, which categorizes seizures into three phases: warning, ictal activity and postictal recovery. The recovery phase is subdivided into three components (cognitive, emotional and physical aspects of recovery), each of which is rated for frequency, severity and bothersome. Overall assessment of seizure severity is measured with the last two items.~Items are positively scored from a scale of 1-7, with lower scores representing a better status. 1 = none, never or mild and 7 = extremely frequent, severe or high.~The severity was reported for seizures occuring throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks)."|16 weeks|Safety population. 4 subjects were missing data (one in the gammacore group and 3 in the sham group) 3 subjects in the gammacore group were missing data in phase 3|||units on a scale||Standard Deviation|Mean
2625651|NCT01910129|Secondary|Duration of Seizure|Duration of seizure was recorded by the subject in the subject diary throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).|16 weeks|"Safety population. One subject has missing data in the active gammacore group. 2 subjects were missing data in phase 3 (1 from phase 2 active group and 1 from the phase 2 sham group)~1 subject in the phase 3 sham group reported 0 seizures during this phase"|||minutes||Standard Deviation|Mean
2625652|NCT01910129|Primary|Frequency of Seizures|The seizure frequency was collected in the subject diary throughout Intervention 1/Phase 2 (8 weeks) and Intervention 2/Phase 3 (8 weeks).|16 weeks|safety population 3 subjects were missing data in phase 3 (2 from phase 2 active group and 1 from the phase 2 sham group)|||seizures||Full Range|Mean
2625653|NCT01910116|Secondary|Number of OMERACT-OARSI Responder|Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment|Baselie and 16 weeks||||participants|||Number
2625654|NCT01910116|Secondary|Number of OMERACT-OARSI Responder|Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment|Baseline and 12 weeks||||participants|||Number
2625655|NCT01910116|Secondary|Number of OMERACT-OARSI Responder|Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment|Baseline and 8 weeks||||participants|||Number
2625656|NCT01910116|Secondary|Number of OMERACT-OARSI Responder|Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment|Baseline and 4 weeks||||participants|||Number
2625657|NCT01910116|Secondary|Acetaminophen Rescue|yes = AAP rescue use, no = no AAP rescue use|12 weeks and 16 weeks||||participants|||Number
2625658|NCT01910116|Secondary|Acetaminophen Rescue|yes = AAP rescue use, no = no AAP rescue use|8 weeks and 12 weeks||||participants|||Number
2625659|NCT01910116|Secondary|Acetaminophen Rescue|yes = AAP rescue use, no = no AAP rescue use|4 weeks and 8 weeks||||participants|||Number
2625660|NCT01910116|Secondary|Acetaminophen Rescue|yes = AAP rescue use, no = no AAP rescue use|Baseline 4 weeks||||participants|||Number
2625661|NCT01910116|Secondary|Swollen Joint Count, Change From Baseline|"Change in Swollen joint count (SJC) at 16 weeks from baseline = SJC at 16 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 16 weeks||||Joints||Inter-Quartile Range|Median
2625662|NCT01910116|Secondary|Swollen Joint Count, Change From Baseline|"Change in Swollen joint count (SJC) at 12 weeks from baseline = SJC at 12 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 12 weeks||||Joints||Inter-Quartile Range|Median
2625663|NCT01910116|Secondary|Swollen Joint Count, Change From Baseline|"Change in Swollen joint count (SJC) at 8 weeks from baseline = SJC at 8 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 8 weeks||||Joints||Inter-Quartile Range|Median
2625664|NCT01910116|Secondary|Swollen Joint Count, Change From Baseline|"Change in Swollen joint count (SJC) at 4 weeks from baseline = SJC at 4 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 4 weeks||||Joints||Inter-Quartile Range|Median
2625665|NCT01910116|Secondary|Tender Joint Count, Change From Baseline|"Change in Tender joint count (TJC) at 16 weeks from baseline = TJC at 16 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 16 weeks||||joints||Inter-Quartile Range|Median
2625666|NCT01910116|Secondary|Tender Joint Count, Change From Baseline|"Change in Tender joint count (TJC) at 12 weeks from baseline = TJC at 12 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 12 weeks||||joints||Inter-Quartile Range|Median
2625667|NCT01910116|Secondary|Tender Joint Count, Change From Baseline|"Change in Tender joint count (TJC) at 8 weeks from baseline = TJC at 8 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 8 weeks||||Joints||Inter-Quartile Range|Median
2625668|NCT01910116|Secondary|Tender Joint Count, Change From Baseline|"Change in Tender joint count (TJC) at 4 weeks from baseline = TJC at 4 weeks - TJC at baseline..~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 4 weeks||||joints||Inter-Quartile Range|Median
2625669|NCT01910116|Secondary|Physician Global Assessment, Change From Baseline|"Change in Physician global assessment (PhGA) at 16 weeks from baseline = PhGA at 16 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 16 weeks||||units on a scale||Inter-Quartile Range|Median
2625741|NCT01909674|Primary|Comparison of the Effectiveness of Nasal Versus Oronasal CPAP Masks|Total Sleep Time (TST) The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode.|3 weeks for each mask condition|higher values represent a better outcome|||minutes||Standard Deviation|Mean
2625670|NCT01910116|Secondary|Physician Global Assessment, Change From Baseline|"Change in Physician global assessment (PhGA) at 12 weeks from baseline = PhGA at 12 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 12 weeks||||units on a scale||Inter-Quartile Range|Median
2625671|NCT01910116|Secondary|Physician Global Assessment, Change From Baseline|"Change in Physician global assessment (PhGA) at 8 weeks from baseline = PhGA at 8 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 8 weeks||||units on a scale||Inter-Quartile Range|Median
2625672|NCT01910116|Secondary|Physician Global Assessment, Change From Baseline|"Change in Physician global assessment (PhGA) at 4 weeks from baseline = PhGA at 4 weeks (0-100)- PhGA score at baseline (0-100). GPA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|baseline and 4 weeks||||units on a scale||Inter-Quartile Range|Median
2625673|NCT01910116|Secondary|Patient Global Assessment, Change From Baseline|"Change in Patient global assessment (PGA) at 16 weeks from baseline = PGA at 16 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 16 weeks||||units on a scale||Inter-Quartile Range|Median
2625674|NCT01910116|Secondary|Patient Global Assessment, Change From Baseline|"Change in Patient global assessment (PGA) at 12 weeks from baseline = PGA at 12 weeks (0-100)- PGA score at baseline (0-100). GPA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 12 weeks||||units on a scale||Inter-Quartile Range|Median
2625675|NCT01910116|Secondary|Patient Global Assessment, Change From Baseline|"Change in Patient global assessment (PGA) at 8 weeks from baseline = PGA at 8 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 8 weeks||||units on a scale||Inter-Quartile Range|Median
2625676|NCT01910116|Secondary|Patient Global Assessment, Change From Baseline|"Change in Patient global assessment (PGA) at 4 weeks from baseline = PGA at 4 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 4 weeks||||units on a scale||Inter-Quartile Range|Median
2625677|NCT01910116|Secondary|AUSCAN Function Change at 16 Weeks From Baseline|"Change in AUSCAN function score at 16 weeks from baseline = Function score at 16 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 16 weeks||||units on a scale||Inter-Quartile Range|Median
2625678|NCT01910116|Secondary|AUSCAN Function Change at 12 Weeks From Baseline|"Change in AUSCAN function score at 12 weeks from baseline = Function score at 12 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 12 weeks||||units on a scale||Inter-Quartile Range|Median
2625679|NCT01910116|Secondary|AUSCAN Function Change at 8 Weeks From Baseline|"Change in AUSCAN function score at 8 weeks from baseline = Function score at 8 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 8 weeks||||units on a scale||Inter-Quartile Range|Median
2625680|NCT01910116|Secondary|AUSCAN Function Change at 4 Weeks From Baseline|"Change in AUSCAN function score at 4 weeks from baseline = Function score at 4 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Basline and 4 weeks||||units on a scale||Inter-Quartile Range|Median
2625681|NCT01910116|Secondary|AUSCAN Stiffness at 16 Weeks Change From Baseline|"Change in AUSCAN stiffness score at 16 weeks from baseline = Stiffness at 16 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline, 16 weeks||||units on a scale||Inter-Quartile Range|Median
2625682|NCT01910116|Secondary|AUSCAN Stiffness at 12 Weeks Change From Baseline|"Change in AUSCAN stiffness score at 12 weeks from baseline = Stiffness at 12 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Basline and 12 weeks||||units on a scale||Inter-Quartile Range|Median
2625683|NCT01910116|Secondary|AUSCAN Stiffness at 8 Weeks Change From Baseline|"Change in AUSCAN stiffness score at 8 weeks from baseline = Stiffness at 8 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|baseline and 8 weeks||||units on a scale||Inter-Quartile Range|Median
2625684|NCT01910116|Secondary|AUSCAN Stiffness at 4 Weeks Change From Baseline|"Change in AUSCAN stiffness score at 4 weeks from baseline = Stiffness at 4 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 4 weeks||||units on a scale||Inter-Quartile Range|Median
2625685|NCT01910116|Secondary|AUSCAN Pain Score at 16 Weeks From Baseline|"Change in AUSCAN pain score at 16 weeks from baseline = Pain at 16 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 16 weeks||||units on a scale||Inter-Quartile Range|Median
2625686|NCT01910116|Secondary|AUSCAN Pain Score at 12 Weeks From Baseline|"Change in AUSCAN pain score at 12 weeks from baseline = Pain at 12 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline, 12 weeks||||units on a scale||Inter-Quartile Range|Median
2625687|NCT01910116|Secondary|AUSCAN Pain Score at 8 Weeks From Baseline|"Change in AUSCAN pain score at 8 weeks from baseline = Pain at 8 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline, 8 weeks||||units on a scale||Inter-Quartile Range|Median
2625688|NCT01910116|Primary|AUSCAN Pain Change at 4 Weeks From Baseline|"Change in AUSCAN pain score at 4 weeks from baseline = Pain at 4 weeks (0-100) - Pain at baseline (0-100).~AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).~Negative value means improvement from baseline~Positive value means deterioration from baseline"|Baseline and 4 weeks||||units on a scale||Inter-Quartile Range|Median
2625689|NCT01910064|Secondary|Percent Changes From Baseline in Total Lesion Counts||Baseline, Weeks 1, 2, 4, and Months 2, 3, 6, 9, 12||||percent change||Full Range|Median
2625690|NCT01910064|Primary|Local Tolerability (Stinging/Burning)|Highest Severity of Local Tolerability Scores Worse Than Baseline|12 months||||subjects|||Number
2625691|NCT01910064|Primary|Local Tolerability (Pruritus)|Highest Severity of Local Tolerability Scores Worse Than Baseline|12 months||||participants|||Number
2625692|NCT01910064|Primary|Local Tolerability (Dryness)|Highest Severity of Local Tolerability Scores Worse Than Baseline|12 months||||participants|||Number
2625693|NCT01910064|Primary|Local Tolerability (Scaling)|Highest severity of Local tolerability scores worth than base line|12 months||||participants|||Number
2625694|NCT01910064|Primary|Local Tolerability (Erythema)|Highest severity of Local tolerability scores worth than base line|12 monhths||||participants|||Number
2625695|NCT01909973|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The PHQ-9 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-27. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-27 is severe.|Baseline, Week 4, Week 8, Week 12||||units on a scale||Standard Deviation|Mean
2625696|NCT01909973|Primary|Adherence to Antidepressant Medication|Frequency of medication usage from baseline to end of treatment|Baseline, Week 4, Week 8, Week 12||||Participants|||Count of Participants
2625697|NCT01909804|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2625698|NCT01909804|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2625699|NCT01909804|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
2625700|NCT01909804|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants randomized into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2625701|NCT01909791|Secondary|Cumulative Number of Intraocular Injections of 2.0-mg Aflibercept Received Per Participant||2 years||||Injections|Eyes|Standard Deviation|Mean
2625702|NCT01909791|Secondary|Number of Eyes With ≥ 2-step Improvement of Diabetic Retinopathy|Includes eyes with baseline severity level of 35 (mild non-proliferative diabetic retinopathy) or greater based on reading center grading of color fundus photographs using the Early Treatment Diabetic Retinopathy Study severity scale. Excludes eyes with severity level 60 at baseline since improvement is not possible in these eyes.|2 years||||Eyes|Eyes||Count of Units
2625703|NCT01909791|Secondary|Cumulative Number of Focal/Grid Photocoagulation Sessions Performed Per Participant||2 years|The initial laser session was completed for all eyes in the initial laser group.|||Focal/grid photocoagulation session|Eyes|Standard Deviation|Mean
2625704|NCT01909791|Secondary|Number of Eyes With no Center-involved Diabetic Macular Edema and at Least 10% Central Subfield Thickness Decrease|Center-involved diabetic macular edema defined as follows by central subfield thickness according to optical coherence tomography machine and sex: Heidelberg Spectralis ≥ 305 µm in women and ≥ 320 µm in men, and Zeiss Cirrus ≥ 290 µm in women and ≥ 305 µm in men.|2 years||||Eyes|Eyes||Count of Units
2625705|NCT01909791|Secondary|Number of Eyes With at Least 1 or 2 Logarithmic-step Central Subfield Thickness Improvement and Worsening|Logarithmic transformation of optical coherence tomography central subfield thickness is calculated by taking the log base 10 of the ratio of the central subfield thickness divided by 200 and rounding to the nearest hundredth. The change is the change in the log values.|2 years||||Eyes|Eyes||Count of Units
2625706|NCT01909791|Secondary|Change in OCT Central Subfield Thickness From Baseline|Measured using spectral-domain optical coherence tomography (OCT).|1 year||||microns|Eyes|Standard Deviation|Mean
2625707|NCT01909791|Secondary|Change in E-ETDRS Visual Acuity Letter Score From Baseline|Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).|2 years||||units on a scale|Eyes|Standard Deviation|Mean
2625762|NCT01909336|Secondary|Adverse Reactions Attributed to Acute Plasma Sodium Changes|Adjudicated Morbidity Attributed to Acute Plasma Sodium Changes assessed at 8 hours|8 hours||||Minor Adverse Reactions|||Number
2625708|NCT01909791|Secondary|Number of Eyes With at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline|Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).|2 years||||Eyes|Eyes||Count of Units
2625709|NCT01909791|Secondary|For Eyes Randomized to Initial Laser Photocoagulation and Initial Observation Groups, the Percentage Receiving Aflibercept Treatment||2 years||||Eyes|Eyes||Count of Units
2625710|NCT01909791|Secondary|Number of Eyes With ≥ 2-step Worsening of Diabetic Retinopathy|Includes eyes with baseline severity level of 75 (high-risk proliferative diabetic retinopathy) or less based on reading center grading of color fundus photographs using the Early Treatment Diabetic Retinopathy Study severity scale.|2 years||||Eyes|Eyes||Count of Units
2625711|NCT01909791|Secondary|Cumulative Number of Intraocular Injections of 2.0-mg Aflibercept Received Per Participant||1 year||||Injections|Eyes|Standard Deviation|Mean
2625712|NCT01909791|Secondary|Number of Eyes With no Center-involved Diabetic Macular Edema and at Least 10% Central Subfield Thickness Decrease|Center-involved diabetic macular edema defined as follows by central subfield thickness according to optical coherence tomography machine and sex: Heidelberg Spectralis ≥ 305 µm in women and ≥ 320 µm in men, and Zeiss Cirrus ≥ 290 µm in women and ≥ 305 µm in men.|1 year||||Eyes|Eyes||Count of Units
2625713|NCT01909791|Secondary|Number of Eyes With at Least 1 or 2 Logarithmic-step Central Subfield Thickness Improvement and Worsening|Logarithmic transformation of optical coherence tomography central subfield thickness (CST) is calculated by taking the log base 10 of the ratio of the central subfield thickness divided by 200 and rounding to the nearest hundredth. The change is the change in the log values.|1 year||||Eyes|Eyes||Count of Units
2625714|NCT01909791|Secondary|Change in OCT Central Subfield Thickness From Baseline||2 years||||microns|Eyes|Standard Deviation|Mean
2625715|NCT01909791|Secondary|Change in E-ETDRS Visual Acuity Letter Score From Baseline Over 2 Years (Area Under the Curve)|Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800). The area under the curve (units = letters·years) was divided by 2 years (units = years) to obtain an average change in letter score (units = letters) over the 2-year follow-up.|2 year|Best-corrected visual acuity letter score as measured by a certified tester using an electronic visual acuity testing machine based on the early treatment diabetic retinopathy study method . Best value on the scale 100, worst 0.|||units on a scale|Eyes|Standard Deviation|Mean
2625716|NCT01909791|Secondary|Change in E-ETDRS Visual Acuity Letter Score From Baseline|Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).|1 year||||units on a scale|Eyes|Standard Deviation|Mean
2625717|NCT01909791|Secondary|Number of Eyes With at Least 5-letter Increase or at Least 5-, 10-, or 15-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline|Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).|1 year||||Eyes|Eyes||Count of Units
2625718|NCT01909791|Primary|Number of Eyes With at Least 5-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline|Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).|2 years||||Eyes|Eyes||Count of Units
2625719|NCT01909778|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|from intake of the second dose Faldaprevir up to 9 days|Only one patient was treated and completed this study; he was the only patient analyzed.|||participants|||Number
2625720|NCT01909778|Secondary|Assessment of Tolerability by Investigator|"The investigator has assessed tolerability based on adverse events and the laboratory evaluation. Tolerability was assessed by the investigator according to the categories 1=good, 2=satisfactory, 3=not satisfactory, and 4=bad."|Day 6 of period 1 and 2|Only one patient was treated and completed this study; he was the only patient analysed.|||units on a scale|||Number
2625721|NCT01909778|Secondary|MRTpo|Mean residence time of the analyte in the body after oral administration (MRTpo).|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.|||hours||Standard Deviation|Mean
2625722|NCT01909778|Secondary|Vz/F|Apparent volume of distribution during the terminal phase (Vz/F) following an extravascular dose (at steady state).|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.|||Liter|||Number
2625723|NCT01909778|Secondary|CL/F|"Apparent clearance of the analyte in plasma following extravascular administration (CL/F).~The apparent clearance after oral administration will be determined according to the following equation: CL or CL/F=dose/AUC0-∞. (F=absolute bioavailability factor)"|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.|||mL/min|||Number
2625724|NCT01909778|Secondary|t1/2|Elimination half-life (t1/2). The terminal half-life will be calculated from the terminal rate constant.|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.|||hours|||Number
2625725|NCT01909778|Secondary|AUC0-tz|Area under the concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration (AUC0-tz).|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.|||h*ng/mL|||Number
2625726|NCT01909778|Secondary|Tmax|Time at which the maximum plasma concentration occurs (tmax). Individual tmax values will be directly determined from the plasma concentration time profiles.|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.|||hours|||Number
2625727|NCT01909778|Primary|Cmax|Maximum plasma concentration (Cmax). Individual Cmax values will be directly determined from the plasma concentration time profiles.|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.|||ng/mL|||Number
2625728|NCT01909778|Primary|AUC 0-∞|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞).|-0:15, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 8:00, 12:00, 16:00, 20:00, 24:00, 48:00, 72:00, 96:00, 120:00 h (hours) after drug administration on day 1 and day 15|Only one patient was treated and completed this study; he was the only patient analysed.|||h*ng/mL|||Number
2625729|NCT01909713|Secondary|Subject Satisfaction Questionnaire - Moisturizer|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).|Day 22||||participants|||Number
2625730|NCT01909713|Secondary|Subject Satisfaction Questionnaire - Face Wash|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).|Day 22||||participants|||Number
2625731|NCT01909713|Secondary|Hydration (Corneometry)|"Hydration was assessed using corneometry at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Corneometry measures the hydration status of the skin. An increase in corneometry values indicates an increase in the hydration status of the skin, and vice versa. The test is procedure specific, so results are reported in arbitrary units."|Week 3||||arbitrary units||Standard Deviation|Mean
2625732|NCT01909713|Secondary|Barrier Function (TEWL)|Barrier function was assessed by measuring transepidermal water loss (TEWL) at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). TEWL measures water loss through the epidermis (for example, by evaporation). Measuring TEWL is a well-established way to assess the skin's water-barrier function. High TEWL values indicate impaired skin barrier function; low values indicate normal barrier function.|Week 3||||g/m2/h||Standard Deviation|Mean
2625733|NCT01909713|Secondary|Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Tightness|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Tightness: 0 = none, no tightness; 1 = mild, slight tightness, not really bothersome; 2 = moderate, definite tightness sensation that is somewhat bothersome; 3 = severe, tightness sensation that causes definite discomfort and may interrupt daily activities and/or sleep|Week 3||||participants|||Number
2625734|NCT01909713|Secondary|Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Stinging|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Stinging: 0 = none, no stinging; 1 = mild, slight stinging sensation, not really bothersome; 2 = moderate, definite stinging sensation that is somewhat bothersome; 3 = severe, stinging sensation that causes definite discomfort and may interrupt daily activities and/or sleep|Week 3||||participants|||Number
2625735|NCT01909713|Secondary|Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Burning|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Burning: 0 = none, no burning; 1 = mild, slight burning sensation, not really bothersome; 2 = moderate, definite warm, burning sensation that is somewhat bothersome; 3 = severe, hot burning sensation that causes definite discomfort and may interrupt daily activities and/or sleep|Week 3||||participants|||Number
2625736|NCT01909713|Primary|Cutaneous Tolerability Based on Visual Inspection - Roughness|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Roughness: 1 - no roughness, skin is fine, silky smooth, 2 - firm (not too rough, not too smooth), 3 - coarse, rough skin, 4 - leathery, flaky skin.|Week 3||||participants|||Number
2625737|NCT01909713|Primary|Cutaneous Tolerability Based on Visual Inspection - Dryness|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Dryness: 0 = no observable scaling; 1 = fine flakes/scaling; 2 = moderate flakes/scaling; 3 = larger flakes/severe scaling.|Week 3||||participants|||Number
2625738|NCT01909713|Primary|Cutaneous Tolerability Based on Visual Inspection - Edema|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Edema: 0 = none; 1 = mild; 2 = moderate; 3 = intense.|Week 3||||participants|||Number
2625739|NCT01909713|Secondary|Cutaneous Tolerability Based on Subject and Parent/Legally Authorized Representative Interview - Itching|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Itching: 0 = none, no itching; 1 = mild, slight itching, not really bothersome; 2 = moderate, definite itching that is somewhat bothersome; 3 = severe, intense itching that may interrupt daily activities and/or sleep|Week 3||||participants|||Number
2625740|NCT01909713|Primary|Cutaneous Tolerability Based on Visual Inspection - Erythema|Cutaneous tolerability based on visual inspection (investigator reported severity scale) was assessed at visit 1 (day 1), visit 2 (day 8), and visit 3 (day 22). Erythema: 0 = none, no observable redness; 1 = very mild, slight redness, spotty or diffuse; 2 = mild, moderate redness; 3 = moderate, intense; 4 = severe, fiery red with edema.|Week 3||||participants|||Number
2625742|NCT01909570|Other Pre-specified|Live Birth Delivery Rate|The delivery of a healthy child (o two)|38 weeks after embryo transfer|Women aged under 38 years, with BMI between 19-29 kg/m2, FSH <15mUI/mL on the third day and first cycle of IVF/ICSI or second cycle after a prior attempt with a positive pregnancy test result. The infertile period must be less of five years, without previous uterine surgery, uterine malformations, neither repeated spontaneous abortions.|||percentage of live birth|||Number
2625743|NCT01909570|Secondary|Multiple Pregnancy Rate|A multiple clinical pregnancy was defined by the presence of more tan one gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy|Seven weeks after embryo transfer|Women aged under 38 years, with BMI between 19-29 kg/m2, FSH <15mUI/mL on the third day and first cycle of IVF/ICSI or second cycle after a prior attempt with a positive pregnancy test result. The infertile period must be less of five years, without previous uterine surgery, uterine malformations, neither repeated spontaneous abortions.|||percentage of multiple pregnancies|||Number
2625744|NCT01909570|Primary|Clinical Pregnancy Rate|A clinical pregnancy was defined by the presence of a gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy|Seven weeks after embryo transfer|Women aged under 38 years, with BMI between 19-29 kg/m2, FSH <15mUI/mL on the third day and first cycle of IVF/ICSI or second cycle after a prior attempt with a positive pregnancy test result. The infertile period must be less of five years, without previous uterine surgery, uterine malformations, neither repeated spontaneous abortions.|||percentage of pregnancy per transfer|||Number
2625745|NCT01909466|Secondary|Mean Change From Baseline in Social Integration Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
2625746|NCT01909466|Secondary|Mean Change From Baseline in Emotional Regulation Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
2625747|NCT01909466|Secondary|Mean Change From Baseline in Physical Functioning Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
2625748|NCT01909466|Secondary|Mean Change From Baseline in Self Control Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
2625763|NCT01909336|Secondary|Dysnatraemias at T8|hyponatraemia (defined as serum sodium < 135 mmol/L), normonatremia (defined as serum sodium 135-145 mmol/L) or hypernatraemia (defined as serum sodium > 145 mmol/L)|8 hours||||participants|||Number
2625749|NCT01909466|Secondary|Mean Change From Baseline in Mental Functioning Score of SWN-S.|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. SWN-S subscale score's each item was rated on a score of 0 (none) to 6 (severe), with higher scores indicating stronger subjective feelings of deficit.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
2625750|NCT01909466|Secondary|Mean Change From Baseline in Total Score of Subject Well-being Under Neuroleptic Treatment-Short Form (SWN-S).|The participant's feeling of their own well-being was assessed using the 20 question SWN-S. The SWN-S was a validated self-report instrument that evaluated the participant's perception of 1 being while receiving antipsychotic medication. The questionnaire consisted of 20 items and 5 subscales (mental functioning, social integration, emotional regulation, physical functioning, self-control) whose items followed in random order. For items marked with a '+', response choices and scoring were as follows: not at all = 1, hardly at all = 2, a little = 3, somewhat = 4, much = 5, very much = 6. For items marked with a '-', the scoring was reversed; response choices and scoring were as follows: not at all = 6, hardly at all = 5, a little = 4, somewhat = 3, much = 2, very much = 1. The total score from the scale ranges from 20 (bad subjective experience) to 120 (perfect subjective experience).|Baseline to Week 20+|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
2625751|NCT01909466|Secondary|Clinical Global Impression-Improvement (CGI-I) Score.|The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition a baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
2625752|NCT01909466|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score.|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
2625753|NCT01909466|Secondary|Mean Change From Baseline in PANSS Negative Sub-scale Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
2625754|NCT01909466|Secondary|Mean Change From Baseline in PANSS Positive Sub-scale Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
2625764|NCT01909336|Primary|Hospital Acquired Hyponatremia|Serum sodium less than 135 mEq/L at 8 hours in a patient with normal serum sodium (135 mEq/L to 145mEq/L) at the beginning of the study|8 hours||||participants|||Number
2625765|NCT01909180|Primary|Image Quality|"Image quality assessment on a 5 point Likert Scale:~5= Diagnostic- Excellent Image Quality 4= Diagnostic- Good Image Quality 3= Diagnostic-Acceptable Image Quality 2= Sub-Optimal Diagnostic with limited additional clinical information~1= Non-Diagnostic"|24 hours|All cases were sufficient and had acceptable, good or excellent image quality|||units on a scale|Participants|Standard Deviation|Mean
2625755|NCT01909466|Secondary|Mean Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS).|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 20|In efficacy analysis, the dataset included all randomized participants who received at least one dose of aripiprazole IM depot injection and had at least one efficacy assessment. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
2625756|NCT01909466|Primary|Mean Change From Baseline Measured by EPS by Barnes Akathisia Rating Scale (BARS).|The BARS consisted of 4 items related to akathisia: objective observation of akathisia by the study physician, subjective feelings of restlessness by the participant, participant distress due to akathisia, and global evaluation of akathisia. To complete this scale, participants were observed while they were seated and then stood for a minimum of 2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral conversation or engaged in activity on the ward) may also be rated. Subjective phenomena were to be elicited by direct questioning. The first 3 items were rated on a 4-point scale, with a score of 0 = absence of symptoms and a score of 3 = severe condition. The global clinical evaluation were made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe).|Baseline to Week 20|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
2625757|NCT01909466|Primary|Mean Change From Baseline Measured by EPS by Abnormal Involuntary Movement Scale (AIMS).|The AIMS assessment consisted of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest (e.g., in the waiting room), and the study physician would make global judgments on the participant's dyskinesia's (items 8 through 10). These items are rated on a five-point scale of severity from 0-4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Overall AIMS scores range from 0 to 42.|Baseline to Week 20|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
2625758|NCT01909466|Primary|Mean Change From Baseline Measured by Extrapyramidal Symptoms (EPS) by Simpson-Angus Scale (SAS).|The SAS consisted of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). The SAS Total Score was the sum of the scores for all 10 items. SAS total score can range from 10 to 50. Each item was rated on a 5-point scale, with a score of 1 =absence of symptoms and a score of 5 =severe condition.|Baseline to Week 20|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
2625759|NCT01909466|Primary|Mean Change From Baseline in Suicidal Ideation Intensity Total Score Via Columbia-suicide Severity Rating Scale (C-SSRS).|Suicidality was monitored throughout the trial using C-SSRS. The C-SSRS addresses the need for standardized classification of suicide reports to assess suicide risk. This scale consisted of Baseline evaluation that assessed the lifetime experience of the participant with suicidal events and suicidal ideation and a post baseline evaluation that focuses on suicidality since the last trial visit. The C-SSRS since last visit form were completed on Day 1 pre-dose and prior to dosing on Days 29, 57, 85, 113, 141/ Early Termination(ET) and prior to pharmacokinetics(PK) sampling on Days 8, 15, 22, 120, 127 and 134. The suicidal ideation intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore,the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation.|Baseline to Last Visit (Day 141)|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
2625760|NCT01909466|Primary|Mean Visual Analog Scale (VAS) Score for Rating of Pain at the Injection Site.|Participants assessed the pain associated with injection of aripiprazole IM using the VAS instrument. This was done approximately 30 minutes pre-dose and 1 hour (±15 min) Post-dose on Days 1, 29, 57, 85 and 113. For the first injection, the pre-dose assessment was of the current injection site. For the injections 2 through 5, the pre-dose assessment was of the prior injection site. Investigator's Assessment of Most Recent Injection Site including pain, swelling, redness, and induration were reported in 4-point categorical scale (1 = absent, 2 = mild, 3 = moderate and 4 = severe) by first injection site at each injection.|Days 1 and 113|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation. In LOCF dataset, missing data at a post-baseline visit were imputed with the value obtained at the nearest preceding visit.|||Units on a scale||Standard Deviation|Mean
2625761|NCT01909466|Primary|Number of Participants With Adverse Events (AEs).|AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life threatening or required inpatient hospitalization or prolonged hospitalization. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.|AEs were recorded from the time the informed consent was signed until follow-up for 28 days after last|The safety sample included all randomized participants who were administered at least one dose of study medication, regardless of any protocol violation.|||participants|||Number
2625766|NCT01909154|Secondary|Efficacy-modification of Magnetic Resonance Imaging (MRI)|Number of patients with a decrease in volume and hyperintensity of intramedullary lesions. In general, in the areas of SCI, variable degree of spinal cord atrophy and hiperintense images are observed. These images corresponds to cysts, gliosis and myelomalacia. After cell administration a reduction of supposed cyst and a decrease or disappearance of hyperintense lesions suggest a patient improvement.|changes in the spinal cord morphology on neuroimaging studies before surgery and 12 months after surgery (follow-up period)||||Patients|||Number
2625767|NCT01909154|Secondary|Efficacy-Urodynamic Studies in Terms of máximum Cystometric Capacity|Urodynamic studies in terms of voluntary micturition in flowmetry or in pressure/flow test, increase in bladder compliance. detrusor pressure (decrease on detrusor pressure is considered a clinical improvement). The neurogenic bladder is one of the biggest problems associated with SCI (spinal cord injury), with important personal and social implications.|Urodynamic studies before surgery and 12 months after surgery (follow-up period)||||cm/H2O||Standard Deviation|Mean
2625768|NCT01909154|Secondary|Efficacy- Changes in the Neurophysiological Parameters Measured as the Number of Patients With SSEPs (Somatosensory Evoked Potentials)|Changes in the neurophysiological parameters (SSEPs, somatosensory evoked potentials) measured as number of patients WITH SSEPs, each patient through underwent neurophysiological studies before treatment, as well as six and 12 months after surgery, paying attention mainly to the presence or abscence of somatosensory evoked potentials (SSEPs), the presence or absence of motor evoked potentials (MEPs) elicited by magnetic stimulation over the scalp, and to electromyographic (EMG) recording of motor unit potentials in infralesional muscles. Previous to cell therapy in any of the patients SSEPs were recorded.|Changes in the level neurophysiological parameters improvement (baseline visit) and 6, 12 months after surgery (follow-up period)||||number of patients with SSEPs|||Number
2625769|NCT01909154|Secondary|Efficacy-Changes in the Level of Chronic Pain Based on the IANR-SCIFRS Scale (Pain Section)|"Changes in the level of chronic pain, measured by the pain section of the IANR-SCIFRS (Spinal cord injury functional rating scale (SCI-FRS) of the international association of neuroestoratology (IANR). The minimum posible score is 0, and the máximum posible score is 48, being a score of 48 a normal functioning across all categories, and 0 a severe degree of functional hándicap (significant impact of daily life).~Pain is classified as no pain; mild pain, ordinary pain killer, effective;severe pain, narcotics required; extreme pain, uncontrolled."|Changes in the level of Chronic pain before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)||||units on a scale||Standard Deviation|Mean
2625770|NCT01909154|Secondary|Efficacy-Sensitivity Recovery Using ASIA Scale|"Sensitivity recovery was measured using the ASIA (American Spinal Injury Association) scale to measure the Surface sensitivity (LTS), pain sensitivity (PPS), and the degree of motor function in key muscles (MS). The sum of MS, LTS, and PPS configure total ASIA score. A minimum possible score is 0 points. A maximum possible score is 224 points for a patient with normal sensation.~ASIA score was obtained before surgery, and 3, 6, 9 and 12 months after surgery. Mean and standard deviation for the 12 patients were obtained at all the time points and statistically analyzed."|sensitivity before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)||||units on a scale||Standard Deviation|Mean
2625771|NCT01909154|Primary|Safety-Number of Adverse Events|"Clinical evaluation of possible adverse effects is performed daily at the first week after the first administration of stem cells and weekly until the 6 months follow-up visit and then at month 9 and 12. .~During the first stem cells administration (during surgery): Changes in vital signs (ECG, Blood Pressure (BP), Heart Rate (HR) were evaluated~During the second stem cells administration: Changes in vital signs (BP, HR), headache and meningeal irritation were evaluated~During the first weeks, after the first and the second administrations, the possibility of meningeal irritation, headache and infectious complications were considerate.~MedDRA stardards are followed"|Up to 12 months|Autologous bone marrow adult mesenchymal stem cells expanded in vitro. Administered by Intrathecal injection (subarachnoid and intramedullary). Depending on centromedullary post-traumatic injury: bone marrow stromal stem cells administration (MSCs) at the minimum dose of 100x106 followed by subarachnoid administration of 30x106 MSCs,3 months later|||Adverse events|||Number
2625772|NCT01909141|Other Pre-specified|Safety of Pioglitazone as Regards Serum Creatinine|serum creatinine was measured at the end of the study period (after 3 months) in both groups.|3 months||||mg/dL||Standard Deviation|Mean
2625773|NCT01909141|Secondary|Pregnancy Rate||3 months||||participants|||Number
2625774|NCT01909141|Secondary|Endometrial Thickness||3 months||||mm||Standard Deviation|Mean
2625775|NCT01909141|Secondary|Number of Follicles>18mm.||3 months||||follicles||Standard Deviation|Mean
2625776|NCT01909141|Primary|Ovulation Rate||3 months||||percentage of all cycles|||Number
2625777|NCT01909011|Primary|Change From Baseline in Mean Beck Depression Inventory (BDI) Score at Week 2|BDI is a validated, self-report measure used to assess the level of depression symptom severity. BDI values range from 0 (normal) to 63 (extreme depression). Mean Change = (Week 2 Mean Score - Baseline Mean Score).|Baseline to Week 2|Intent to treat population (all participants who received at least one dose of intervention). Last observation carried forward (LOCF) imputation method.|||units on a scale||Standard Deviation|Mean
2625778|NCT01909011|Secondary|Change From Baseline in Mean Clinical Global Impressions Illness Severity (CGI-S) Score at Week 2|CGI-S instrument measures the level of severity of illness rated by a qualified clinician. CGI-S values range from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients). Mean Change = (Week 2 Mean Score - Baseline Mean Score).|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
2625779|NCT01909011|Secondary|Change From Baseline in Mean Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score at Week 2|Q-LES-Q is a validated 16-item self-report measure of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning such as physical well-being, work, home, social relationships and leisure activities. Each item is rated on a 1 - 5 point scale. Q-LES-Q values range from 0 (very low quality of life) to 100 (high quality of life). Mean Change = (Week 2 Mean Score - Baseline Mean Score).|Baseline to Week 2||||units on a scale||Standard Deviation|Mean
2625780|NCT01908972|Secondary|Number of Participants With Adverse Drug Reaction|All symptoms associated adverse drug reaction will be checked|up to 16weeks||||Participants|||Count of Participants
2625781|NCT01908972|Secondary|Number of Participants With Gastroesophageal Reflux Within 16 Weeks|Number of Participants With Gastroesophageal reflux within 16 weeks..|up to 16weeks||||Participants|||Count of Participants
2625784|NCT01908972|Secondary|Number of Participants in Which, Glucose Levels Fall (to <50mg/dl), Anytime During the 16 Weeks|Number of Participants in Which, Glucose levels fall (to <50mg/dl), Anytime During the 16 Weeks..|up to 16weeks||||Participants|||Count of Participants
2625785|NCT01908972|Secondary|Number of Participants in Which, the Systolic Blood Pressure Fall of >25% of Baseline Postdose With Child Awake, Anytime During the 16 Weeks|Number of Participants in Which, the Systolic blood pressure fall of >25% of baseline postdose with child awake, Anytime During the 16 Weeks..|up to 16weeks||||Participants|||Count of Participants
2625786|NCT01908972|Secondary|Number of Participants With Drug Compliance Within 16 Weeks|We checked Number of participants with Drug compliance within 16 weeks|After 16 weeks||||Participants|||Count of Participants
2625787|NCT01908972|Secondary|Number of Participants With Regression|Number of participants whose hemangioma showed regression in 16 weeks.|Within 16 weeks||||Participants|||Count of Participants
2625788|NCT01908972|Secondary|Number of Participants With Stop of Proliferation|Number of participants whose hemangioma stop proliferating in 16weeks|After 16 weeks||||Participants|||Count of Participants
2625789|NCT01908972|Secondary|Number of Participants With Reepithelialzation in 16weeks|Number of participants with Reepithelialzation in 16weeks..|After 16 weeks||||Participants|||Count of Participants
2625790|NCT01908972|Secondary|Number of Participants With Size Reduction of Ulceration|size was measure the horizontal and vertical size (2-dimension) of ulceration (from baseline to 16 weeks after medication)|After 16 weeks||||Participants|||Count of Participants
2625791|NCT01908972|Secondary|Number of Participants With Change in Color as Compared to Baseline|Participants were observed for any change in color. The possible change in colors included change to Red/Purple/Blue/Gray/Apricot. Reported are the number of participants who experienced a change in color by the type of color|After 16 weeks||||Participants|||Count of Participants
2625792|NCT01908972|Secondary|Number of Participants in Which, the Heart Rate Fell to <70% of Acceptable Age Related Minimum Post-dose With Child Awake, Anytime During the 16 Weeks|Number of Participants in which, the Heart rate fell to <70% of acceptable age related minimum post-dose with child awake, anytime during the 16 weeks Count of patients whose Heart rate fall to <70% of acceptable age related minimum post-dose with child awake|up to 16weeks||||Participants|||Count of Participants
2625793|NCT01908972|Secondary|Percent Reduction in Hemangioma Volume From Baseline|Percent Reduction in Hemangioma Volume from Baseline (measured by MRI or Sono (from basline to 16 weeks))|After 16 weeks||||% from baseline||Standard Deviation|Mean
2625794|NCT01908972|Primary|Number of Participants With Clinical Response From Baseline in Hemangioma Volume Measured by MRI or SONO|The primary efficacy variable was the clinical response at 16 weeks, classified as follows: when the volume did not increase or decreased by less than 25% after treatment began, we defined it as stop of progression; when the volume decreased by 25% or more compared with the original size, we defined it as regression. Both stop of progression and regressionwere defined as reaction. If the volume at the primary efficacy evaluation point was greater than the size measured when treatment started,we called it an increase. Increase was defined as a nonreaction.|After 16weeks||||Participants|||Count of Participants
2625795|NCT01908907|Other Pre-specified|LCPUFA Levels - Linoleic Acid (LNA)|Linear mixed models were also used to examine the association between each FA of interest and treatment group over time. Since only three time points were available for FA measurement, only a random intercept was included in the models. For these models, the random effect for multiples was again found to be not needed and removed. Primary outcome variables for this analysis included LNA, ALA, ARA and DHA. Only early/late preterm status was included in the model as a covariate since this was a stratification variable. Continuous dependent variables were transformed using the natural logarithm as needed to meet the assumptions of the regression model (this included LNA and ALA).|Baseline, full feedings and discharge||||wt:wt% (composition) of fat in sample||Standard Deviation|Mean
2625796|NCT01908907|Other Pre-specified|LCPUFA Levels - Alpha-linolenic Acid (ALA) in Whole Blood|Linear mixed models were also used to examine the association between each FA of interest and treatment group over time. Since only three time points were available for FA measurement, only a random intercept was included in the models. For these models, the random effect for multiples was again found to be not needed and removed. Primary outcome variables for this analysis included LNA, ALA, ARA and DHA. Only early/late preterm status was included in the model as a covariate since this was a stratification variable. Continuous dependent variables were transformed using the natural logarithm as needed to meet the assumptions of the regression model (this included LNA and ALA).|Baseline (<1 week of age), full enteral feedings and discharge||||wt:wt% (composition) of total fat||Standard Deviation|Mean
2625797|NCT01908907|Secondary|LCPUFA Levels - Arachidonic Acid (ARA) in Whole Blood|Linear mixed models were also used to examine the association between each FA of interest and treatment group over time. Since only three time points were available for FA measurement, only a random intercept was included in the models. For these models, the random effect for multiples was again found to be not needed and removed. Primary outcome variables for this analysis included LNA, ALA, ARA and DHA. Only early/late preterm status was included in the model as a covariate since this was a stratification variable. Continuous dependent variables were transformed using the natural logarithm as needed to meet the assumptions of the regression model (this included LNA and ALA).|At baseline (enrollment, <1 week of age), full feedings and discharge||||wt:wt% of total fat in sample||Standard Deviation|Mean
2625798|NCT01908907|Primary|Feasibility and Tolerability of Daily Enteral DHA Oil - Head Circumference|A linear mixed model was used to explore head circumference over time.|30 days from birth|Comparison between preterm groups that received either DHA oil or MCT (placebo control) oil were made. They had DHA levels measured to be used as a reference population in our NICU.|||Centimeters per day||Standard Error|Mean
2625799|NCT01908907|Primary|Feasibility and Tolerability of Daily Enteral DHA Oil - Length Change|A linear mixed model was used to explore length over time.|30 days from birth|Comparison between preterm groups that received either DHA oil or MCT (placebo control) oil were made. They had DHA levels measured to be used as a reference population in our NICU.|||Centimeters per day||Standard Error|Mean
2625893|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||µmol/mL||Standard Deviation|Mean
2625800|NCT01908907|Primary|Long Chain Polyunsaturated Fatty Acid (LCPUFA) Levels - Docosahexaenoic Acid (DHA) Levels in Whole Blood|Linear mixed models were also used to examine the association between each FA of interest and treatment group over time. Since only three time points were available for FA measurement, only a random intercept was included in the models. For these models, the random effect for multiples was again found to be not needed and removed. Primary outcome variables for this analysis included LNA, ALA, ARA and DHA. Only early/late preterm status was included in the model as a covariate since this was a stratification variable. Continuous dependent variables were transformed using the natural logarithm as needed to meet the assumptions of the regression model (this included LNA and ALA).|At baseline (enrollment, < 1 week of age), full feedings, discharge||||mol% (composition) of fat||Standard Deviation|Mean
2625801|NCT01908907|Primary|Feasibility and Tolerability of Daily Enteral DHA Oil - Weight Change|A linear mixed model was used to explore weight over time.|30 days from birth|Comparison between preterm groups that received either DHA oil or MCT (placebo control) oil were made. They had DHA levels measured to be used as a reference population in our NICU.|||Grams per day||Standard Error|Mean
2625802|NCT01908907|Primary|Days to Reach Full Enteral Feedings and Days on Study Oil.|This study was designed to determine feasibility and tolerability of enteral DHA supplementation, but was not intended to determine the effects of DHA on health related outcomes. Tolerability was measured by days to reach full enteral feedings, days on study oil, GA at completion of the study and postnatal growth. The days to reach full enteral feedings was defined as enteral intake of 100kcal/kg/d. Safety and tolerability was closely monitored under the oversight of an independent DSMB.|From enrollment until the infant reaches full feed or is discharged from the NICU, whichever comes first, assessed up to 50 days.|Comparison between preterm groups that received either DHA oil or MCT (placebo control) oil were made.|||days||Standard Deviation|Mean
2625803|NCT01908842|Secondary|VAS Craving Scores: Stabilization/Maintenance|"Absolute mean ± standard deviation values for VAS cravings scores on Days 3, 4, 8, 15, and 22; the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)"|Days 3 through 22|Full analysis population - number of enrolled patients at the beginning of the measurement period|||units on a scale||Standard Deviation|Mean
2625804|NCT01908842|Secondary|Visual Analog Scale (VAS) Cravings: Induction|"Absolute mean ± standard deviation values for VAS cravings at baseline, 0.5 h, 1.5 h, 3 h, and 6 post dose on Day 1, and Day 2; the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)"|Days 1 and 2|Full Analysis Population - number of enrolled patients at the beginning of the measurement period|||units on a scale||Standard Deviation|Mean
2625805|NCT01908842|Secondary|SOWS Total Scores: Stabilization/Maintenance|Absolute ± mean standard deviation values for SOWS total scores on Days 2, 3, 4, 8, 15, and 22; SOWS scores ranged from 0-64, with a lower score being more favorable|Days 3 through 22|Full Analysis Population - number of enrolled patients at the beginning of the measurement period|||units on a scale||Standard Deviation|Mean
2625806|NCT01908842|Primary|Primary Endpoints of Retention in Treatment at Days 3 and 15|Retention rates (number of patients retained) for the primary efficacy endpoints of retention in treatment at Days 3 and 15, which was defined as the number of patients who received treatment on Days 3 and 15.|Day 3 and Day 15|Per protocol population|||participants|||Number
2625807|NCT01908842|Secondary|Subjective Opiate Withdrawal Scale (SOWS) Scores: Induction|Absolute ± mean standard deviation values for SOWS total scores at baseline, 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; SOWS score ranges from 0-64, with a lower score being more favorable|Days 1 and 2|Full analysis population - number of enrolled patients at the beginning of the measurement period|||units on a scale||Standard Deviation|Mean
2625808|NCT01908842|Secondary|COWS Total Scores: Stabilization/Maintenance|Absolute ± mean standard deviation values for COWS total scores at Days 3, 4, 8, 15, and 22; COWS scores range from 0-48, with a lower score being more favorable|Days 3 through 22|Full analysis population - - number of enrolled patients at the beginning of the measurement period|||units on a scale||Standard Deviation|Mean
2625809|NCT01908842|Secondary|Clinical Opiate Withdrawal Scale (COWS) Scores: Induction|Absolute ± mean standard deviation values for COWS total scores at baseline; 0.5 h, 1.5 h, 3 h, and 6 h post dose on Day 1, and Day 2; COWS scores range from 0-48, with a lower score being more favorable|Days 1 and 2|Full Analysis Population - number of enrolled patients at the beginning of the measurement period|||units on a scale||Standard Deviation|Mean
2625810|NCT01908829|Secondary|Change From Baseline in Post Void Residual (PVR) Volume|PVR Volume was assessed by bladder scan.|Baseline and weeks 4, 8 & 12|The analysis population consisted of the SAF with data available at each time point.|||mL||Standard Deviation|Mean
2625811|NCT01908829|Secondary|Number of Participants With Adverse Events (AEs)|AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures & which does not necessarily have a causal relationship with this treatment. Treatment-Emergent Adverse Event (TEAE) referred to an adverse event which started or worsened in the period from first double-blind medication intake until 30 days after the last double-blind medication intake.|From first dose of double blind treatment until 30 days after last dose (up to 16 weeks)|The analysis population consisted of the Safety Analysis Set, the SAF comprised all randomized participants who received at least 1 dose of double-blind treatment.|||Participants|||Count of Participants
2625812|NCT01908829|Secondary|Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC|The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||percentage of participants|||Number
2625813|NCT01908829|Secondary|Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC|The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||percentage of participants|||Number
2625814|NCT01908829|Secondary|Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score|HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||percentage of participants|||Number
2625815|NCT01908829|Secondary|Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity).|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||percentage of participants|||Number
2625816|NCT01908829|Secondary|Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline|Micturitions were defined as voluntary urinations (excluding incontinence only episodes).|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||percentage of participants|||Number
2625817|NCT01908829|Secondary|Percentage of Participants With Zero Incontinence Episodes Postbaseline|Incontinence was defined as any involuntary leakage of urine.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||percentage of participants|||Number
2625818|NCT01908829|Secondary|Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours|Incontinence was defined as any involuntary leakage of urine.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||percentage of participants|||Number
2625819|NCT01908829|Secondary|Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC)|The PGIC was a 2-part questionnaire, assessing both the change in the participant's overall condition (Patient Impression in General Health (PIBS)) and change in bladder condition since the start of the study (Patient Impression in General Health (PIGH)) (from very much worse to very much improved). The CGIC was a single questionnaire assessing the participant's change in bladder condition since the beginning of the study (Clinician Impression in Bladder Symptoms (CIBS)).|End of treatment (up to 12 weeks)|LOCF was used for EoT. The analysis population consisted of the FAS.|||participants|||Number
2625820|NCT01908829|Secondary|Change From Baseline in Patient Perception Bladder Control (PPBC) Score|The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. PPBC score: 1-no problem, 2- some very minor problems, 3-some minor problems, 4-moderate problems, 5-severe problems, 6-many severe problems.|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
2625821|NCT01908829|Secondary|Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score|The TS-VAS rated participant satisfaction with treatment on a scale from 0 (No, not at all) to 10 (Yes, completely).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
2625822|NCT01908829|Secondary|Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
2625823|NCT01908829|Secondary|Change From Baseline in OAB-q HRQL Subscale Score: Sleep|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
2625824|NCT01908829|Secondary|Change From Baseline in OAB-q HRQL Subscale Score: Concern|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
2625825|NCT01908829|Secondary|Change From Baseline in OAB-q HRQL Subscale Score: Coping|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
2625826|NCT01908829|Secondary|Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
2625894|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||mg/dL||Standard Deviation|Mean
2625895|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||mg/dL||Standard Deviation|Mean
2625827|NCT01908829|Secondary|Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score|The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||units on a scale||Standard Error|Least Squares Mean
2625828|NCT01908829|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression|The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.|Baseline and EoT (up to 12 weeks)|LOCF was used for EoT. The analysis population consisted of the FAS.|||participants|||Number
2625829|NCT01908829|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort|The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.|Baseline and EoT (up to 12 weeks)|LOCF was used for EoT. The analysis population consisted of the FAS.|||participants|||Number
2625830|NCT01908829|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities|The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.|Baseline and EoT (up to 12 weeks)|LOCF was used for EoT. The analysis population consisted of the FAS.|||participants|||Number
2625831|NCT01908829|Secondary|Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care|The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.|Baseline and EoT (up to 12 weeks)|LOCF was used for EoT. The analysis population consisted of the FAS.|||participants|||Number
2625832|NCT01908829|Secondary|Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility|The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.|Baseline and EoT (up to 12 weeks)|LOCF was used for EoT. The analysis population consisted of the FAS.|||participants|||Number
2625833|NCT01908829|Secondary|Number of Nocturia Episodes Reported Over 3-Day Diary|The number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) during sleeping time during the 3-day micturition diary period. This was calculated using the sum of each nocturia episode recorded on valid diary days during the 3-day micturition diary period.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one nocturia episode reported in baseline diary were included.|||nocturia episodes||Standard Error|Mean
2625834|NCT01908829|Secondary|Change From Baseline in Mean Number of Nocturia Episodes|Mean number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) while sleeping during the 3-day diary period, divided by the number of valid diary days during the diary period. Night time episode of incontinence only was not considered a nocturia episode. Nocturia episodes were counted for each micturition record which occurred between the date/time of going to bed with intention to sleep and the date/time of getting up with intention to stay awake on a valid diary day & which was accompanied by a sleep interruption. Nocturia only determined for those who were not night-shift workers.|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one nocturia episode reported in baseline diary were included.|||nocturia episodes||Standard Error|Least Squares Mean
2625835|NCT01908829|Secondary|Number of Pads Used During the 3-Day Diary|The number of pads used was defined as the number of times a participant recorded a new pad used during the 3-day micturition diary period. This was calculated using the sum of each record with new pad checked. Only records with new pad checked on a valid diary day were counted.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants who reported use of at least one pad in baseline diary were included.|||pads||Standard Error|Mean
2625836|NCT01908829|Secondary|Change From Baseline in Mean Number of Pads Per 24 Hours|The mean number of pads per 24 hours was defined as the average number of times a participant recorded a new pad used per day during the 3-day micturition diary period. This was calculated using the number of new pads used during valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period.|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with reported use of at least one pad reported in baseline diary were included.|||pads||Standard Error|Least Squares Mean
2625847|NCT01908816|Secondary|Proportion of Patients With Angiographic Leakage|Angiography was taken via fluorescein angiography. Any increases of angiographic leakage was counted between baseline and month 3. Also any decreases of angiographic leakage was counted between baseline and 3 month.|3 months, 12 month|Intent-to-treat population (ITT): all patients who received at least one application of study treatment and had at least one post-baseline efficacy assessment. The ITT population was the main analysis set for efficacy evaluations. The (n) represent the number of assessed value.|||Participants|||Number
2625837|NCT01908829|Secondary|Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours|An urgency episode was defined as the complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes (severity of 3 or 4) per 24 hours was defined as the average number of times a participant recorded an urgency episode (severity of 3 or 4) with or without incontinence per day during the 3-day micturition diary period. Measured using the PPIUS scale. This was calculated using the sum of each record with an urgency episode (severity of 3 or 4) recorded on a valid diary day divided by the number of valid diary days during the 3-day micturition diary period.|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one urgency episode reported in baseline diary were included.|||urgency episodes||Standard Error|Least Squares Mean
2625838|NCT01908829|Secondary|Number of UI Episodes Reported During the 3-Day Diary|Number of UI episodes was calculated using the number of UI episodes recorded on valid diary days during the 3-day micturition diary period. NOTE: Only urgency incontinence episodes recorded on a valid diary day were counted.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one UI episode reported in baseline diary were included.|||UI episodes||Standard Error|Mean
2625839|NCT01908829|Secondary|Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours|UI was defined as the complaint of involuntary urine leakage accompanied by or immediately preceded by urgency. UI was measured using the Patient Perception of Intensity of Urgency Scale (PPIUS), a patient reported outcome validated 5-point categorical scale rating the degree of associated urinary urgency severity (0=No urgency, I felt no need to empty my bladder, but did so for other reasons. 1=Mild, I could postpone voiding as long as necessary, without fear of wetting myself. 2= Moderate, I could postpone voiding for a short while, without fear of wetting myself. 3=Severe, I could not postpone voiding, but had to rush to the toilet in order not to wet myself. 4=Urgency incontinence, I leaked before arriving to the toilet). One urgency incontinence episode was counted for each record of the diary in which the following occurred: incontinence episode or 'both' was recorded & severity of urinary urgency recorded was 3 or 4.|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one UI episode reported in baseline diary were included.|||UI episodes||Standard Error|Least Squares Mean
2625840|NCT01908829|Secondary|Change From Baseline to EoT in Corrected Micturition Frequency (CMF)|CMF was defined as the mean number of micturitions per 24 hours that participants would have at EoT if their fluid intake had remained unchanged since baseline. This was calculated by the MVV per Micturition at baseline multiplied by the mean number of micturitions per 24 hours at baseline divided by the MVV per micturition at EoT.|Baseline and EoT (up to 12 weeks)|LOCF was used. The analysis population consisted of the FAS.|||micturitions||Standard Error|Least Squares Mean
2625841|NCT01908829|Secondary|Change From Baseline in Mean Volume Voided (MVV) Per Micturition|MVV per micturition was defined as MVV (mL) per micturition during last 3 days of the 3-day micturition diary period. MVV per micturition was calculated as the sum of each volume voided for each record with volume voided > 0 on valid diary days divided by the total number of records with a volume voided > 0 on valid diary days during the 3-day micturition diary period.|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||mL||Standard Error|Least Squares Mean
2625842|NCT01908829|Secondary|Number of Incontinence Episodes Reported During the 3-Day Diary|The number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from total number of incontinence episodes on valid diary days recorded during the 3-day micturition diary period.|Weeks 4, 8 and 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||incontinence episodes||Standard Error|Mean
2625843|NCT01908829|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (voluntary urinations (excluding incontinence only episodes)) per 24 hours was derived from number of micturitions recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period (excluding incontinence only episodes).|Baseline and weeks 4, 8 & 12|LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.|||micturitions||Standard Error|Least Squares Mean
2625844|NCT01908829|Secondary|Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours|The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period.|Baseline and weeks 4, 8 & 12|The analysis population consisted of the FAS with data available at each time point.|||incontinence episodes||Standard Error|Least Squares Mean
2625845|NCT01908829|Primary|Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours|The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. The analysis population consisted of the Full Analysis Set (FAS) which comprised of all the Randomized Analysis Set's (RAS) participants who met the following criteria: took at least 1 dose of double-blind study drug after randomization, reported at least 1 micturition in the baseline diary & at least 1 micturition postbaseline & reported at least 1 incontinence episode in the baseline diary. For participants who withdrew before EoT (week 12) and have no measurement available for that diary period, the Last Observation Carried Forward (LOCF) value during the double-blind study period was used as EoT value to derive the primary variable.|Baseline and end of treatment (up to 12 weeks)|The analysis population consisted of the FAS. LOCF was used for EoT.|||incontinence episodes||Standard Error|Least Squares Mean
2625846|NCT01908816|Secondary|Ranibizumab Injection|Number of ranibizumab injections needed by decreased visual acuity and/or increasing retinal thickness in 3 months of observation period|3 months, 12 month|Safety set population: all patients who received at least one application of study treatment and had at least one post-baseline safety assessment. The statement that a patient had no adverse events also constituted a safety assessment. All safety evaluations were carried out on the safety population.|||Number of injections||Standard Deviation|Mean
2625848|NCT01908816|Secondary|"Mean Change From Baseline in Change in Central Retinal Thickness for Patients With CNV (Choroidal Neovascularization) and ME (Macular Edema)"|CRT in micrometers assessed by Optical Tomography (OCT) at each single study visit. A reduction is thickness indicates an improvement is the lesion area|3 months, 12 month|Intent-to-treat population (ITT): all patients who received at least one application of study treatment and had at least one post-baseline efficacy assessment. The ITT population was the main analysis set for efficacy evaluations|||μm||Standard Deviation|Mean
2625849|NCT01908816|Secondary|Proportion of Patient With Vitreous Cavity Hemorrhage Occurrence for Patient With Proliferative Retinopathy|Occurrence of postoperative vitreous cavity hemorrhage|3 months, 12 month|Intent-to-treat population (ITT): all patients who received at least one application of study treatment and had at least one post-baseline efficacy assessment. The ITT population was the main analysis set for efficacy evaluations. (n) is the number of participants with an observed value|||Participants|||Number
2625850|NCT01908816|Secondary|Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma|"The extent of iris neovascularization was assessed by iris photography and graded using the Teich and Walsh grading system. This grading system measures the number of quadrant at iris pupillary zone or iris ciliary zone where iris neovascularization (NV) is observed.~Grade 0 = No iris vascularization, Grade 1= Less than 2 quadrants of NV at iris pupillary zone, Grade 2 = More than 2 quadrants of NV at iris pupillary zone, Grade 3 =Grade 2 + less than 3 quadrants of NV at iris ciliary zone and/or ectropion uveae; Grade 4 =More than 3 quadrants of NV at iris ciliary zone and/or ectropion uveae)"|3 month, 12 month|Intent-to-treat population (ITT): all patients who received at least one application of study treatment and had at least one post-baseline efficacy assessment. The ITT population was the main analysis set for efficacy evaluations|||Teich and Walsh grading|||Number
2625851|NCT01908816|Secondary|Change From Baseline Best Corrected Visual Acuity (BCVA) for Patients With Choroidal Neovascularization (CNV) and Macular Edema (ME)|BCVA change for diseases affecting the macular area either through CNV or ME. BCVA is tested using the ETDRS (Early Treatment Diabetic Retinopathy Study), the Snellen or Monoyer scales. The three scales are designed to measure visual acuity. ETDRS score is expressed in letter, Snellen and Monoyer score in fraction. BCVA assessment is presented in ETDRS after conversion if collected in Snellen or Monoyer. (Monoyer converted to Snellen = 2 x (Monoyer fraction) and Snellen converted to approximate ETDRS letters = 1x log(Snellen fraction). ETDRS letter score was transformed in logMAR unit for statistical analysis (- LogMAR = -(ETDRS-85)/50). The worse ETDRS letter score is 0 (logMAR 2.3) and the best ETDRS letter score is 100 (logMAR -0.3).|3 months, 12 months|Intent-to-treat population (ITT): all patients who received at least one application of study treatment and had at least one post-baseline efficacy assessment. The ITT population was the main analysis set for efficacy evaluations|||Letters||Standard Deviation|Mean
2625852|NCT01908816|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) for ocular and non-ocular events. Due to early termination, only descriptive analysis was conducted.|24 months|Safety population: all patients who received at least one application of study treatment and had at least one post-baseline safety assessment. The statement that a patient had no adverse events also constituted a safety assessment. All safety evaluations were carried out on the safety population.|||Participants|||Count of Participants
2625853|NCT01908803|Secondary|Median Time (in Days) to Cessation of Otorrhea|Median time (in days) to the cessation of otorrhea (ie, otorrhea was absent) was calculated as the number of days from the Day 1 (Visit 1) to the absence of otorrhea in the affected ear(s) as recorded by the parent/guardian via the twice-daily diary. Cessation of otorrhea was defined as ending on the first day that otorrhea was absent from the affected ear(s) and remained absent for any/all subsequent diary entries.|Time to event, up to Day 8|This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.|||days||Standard Error|Median
2625854|NCT01908803|Secondary|Proportion of Subjects With Microbiological Success at the Day 8 Visit|Microbiological success was attained if all pre-therapy bacteria were absent in the Day 8 specimen. In a subject with no otorrhea at Day 8, eradication of pre-therapy bacteria was presumed and the subject was considered a microbiological success.|Day 8|This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.|||percentage of subjects||Standard Deviation|Mean
2625855|NCT01908803|Primary|Proportion of Subjects With Sustained Clinical Cure at Day 3 Visit|A sustained clinical cure at Day 3 was attained if otorrhea was absent at the Day 3 visit and continued to be absent through the last study visit (Day 8 or Early Exit). Proportion of subjects is reported as a percentage.|Day 3 post-treatment up to Day 8 or Early Exit|This analysis population includes all randomized subjects who received at least 1 dose of investigational product and were culture positive at the Day 1 visit in the study ear.|||percentage of subjects|||Number
2625856|NCT01908699|Secondary|Number of Participants With TEAEs, Serious TEAEs, Investigations SOC TEAEs, and Serious Investigations SOC TEAEs|The number of participants experiencing overall Treatment-Emergent Adverse Adverse Events (TEAEs), serious TEAEs, Investigations SOC TEAEs, and serious Investigations SOC TEAEs were reported.Investigations SOC TEAEs were any event categorized within the Investigations System Order Class (SOC) and include adverse events due to physical examinations, vital signs, clinical laboratory parameters, and electrocardiogram findings.|up to 144 weeks|Safety analysis population included all randomized participants who received at least 1 dose of study drug and analyzed as per the actual treatment received. Participants who received both esuberaprost and placebo were assigned to the esuberaprost group.|||Participants|||Number
2625857|NCT01908699|Secondary|Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Week 24|"Area used for the Six Minute Walk Test (6MWT) was pre-measured at 30 meters in length. Rest periods were allowed if patient could no longer continue. If patient needed to rest, he/she could stand or sit and then begin again when rested but the clock continued to run. At the end of 6 minutes, the tester called stop while stopping the watch and then measured the distance walked. For purposes of the 6MWT, if patient was assessed at Baseline using oxygen therapy, all future 6MWT were conducted in the same manner."|Baseline and Week 24|Only participants with both a measurement at baseline and at the given visit are presented.|||meters||Standard Deviation|Mean
2625858|NCT01908699|Secondary|Change in WHO Functional Class From Baseline to Week 24|Change from Baseline in participant clinical status was recorded according to the World Health Organization (WHO) Functional Class. A change from lower to higher functional class (i.e. 'III to IV' or 'II to III') was considered as a deterioration. A change from higher to lower functional class (i.e. 'III to II' or 'II to I') was considered as an improvement. All efficacy results are descriptive; no statistical analysis was conducted.|Baseline and Week 24|Only participants with both a measurement at baseline and at the given visit are presented.|||Participants|||Count of Participants
2625859|NCT01908699|Secondary|Mean Change From Baseline in NT-pro-BNP Levels at Week 24|Plasma NT-proBNP concentration is a useful biomarker for PAH as it is associated with changes in right heart morphology and function.|Baseline and Week 24|Only participants with both a measurement at baseline and at the given visit are presented.|||picomole per liter (pmol/L)||Standard Deviation|Mean
2625860|NCT01908699|Secondary|Mean Change From Baseline in Borg Dyspnea Score at Week 24|The Borg dyspnea score was assessed prior to and following the completion of the 6MWT at Week 24. The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6MWT. Scores range from 0 (for the best condition) to 10 (for the worst condition).|Baseline and Week 24|Only participants with both a measurement at baseline and at the given visit are presented.|||scores on a scale||Standard Deviation|Mean
2625861|NCT01908699|Primary|Number of Participants That Experienced Clinical Worsening|"The number of participants that experienced a Clinical Worsening event confirmed by Endpoint Adjudication Committee at First Maximum Severity. Clinical Worsening was defined as any of these events following the Baseline visit: Death (all causes); Hospitalization due to worsening PAH; Initiation of a parenteral (infusion or sub-cutaneous) prostacyclin, directly related to worsening PAH; Disease progression; Unsatisfactory long-term clinical response.~The number of participants that experienced clinical worsening is presented; time to clinical worsening data was not measured. Given the rate of clinical worsening overall and the large number of censored observations at the end of the study, the mean survival time estimates were not available for this endpoint."|up to 144 weeks||||Participants|||Count of Participants
2625862|NCT01908582|Primary|Pharmacokinetics, Area Under the Plasma Concentration-Time Curve From Time 0 Hour (h) to Infinity (AUC0-∞) of Evacetrapib||Day 1 and Day 16, predose of evacetrapib and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose|All participants who received at least 1 dose of evacetrapib and have evaluable evacetrapib concentration data.|||nanograms * hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
2625863|NCT01908582|Primary|Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib||Day 1 and Day 16, predose of evacetrapib and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose|All participants who received at least 1 dose of rifampin or evacetrapib and had evaluable evacetrapib concentration data.|||hours||Full Range|Median
2625864|NCT01908582|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib||Day 1 and Day 16, predose of evacetrapib and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose|All participants who received at least 1 dose of rifampin or evacetrapib and had evaluable evacetrapib concentration data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2625865|NCT01908530|Secondary|Acceptability Questionnaire|This is a secondary outcome for phases 3 and 4.|24 hours|Data not collected||||||
2625866|NCT01908530|Secondary|Correlation With Venous Blood Glucose|This is a secondary outcome for phases 1 and 2. It is a primary outcome for phase 3. Using MARD.|24 hours|Data not collected||||||
2625867|NCT01908530|Secondary|Detectable Signal|This is a secondary outcome for phases 1 & 2.|24 hours|Data not collected||||||
2625868|NCT01908530|Secondary|Number of Participant Developed Skin Penetration|This done using Optical Coherence Tomography and Confocal Microscopy. Measure = variation in penetration depth of microprobe needles over 24 hours|24 hours||||Participants|||Count of Participants
2625869|NCT01908530|Secondary|Pain Score|The study aims to assess safety of the device with regards to pain degree in comparison to venflon insertion and insertion of an existing continuous glucose monitor (Medtronic iPro2 CGM system, Northridge, California). This will be done at each phase of the four study phases.|24 hours|Data not collected||||||
2625870|NCT01908530|Primary|Difference to the Venous Blood Glucose MARD|Phase 3 of the study aim to assess efficacy of the device in people with type 1 diabetes. This will be done in comparison to venous blood glucose using YSI machine in a controlled environment over 24 hours (phase 3). it was originally planned to then compare this to ISF glucose in ambulatory situation over five days (phase 4) however phase 4 did not go ahead. Measured using mean absolute relative difference with respect to venous blood glucose|24 hours|Only for Phase 3 arm|||percentage|||Number
2625871|NCT01908530|Primary|Number of Participant Developed the Skin Inflammation|The study aims to assess safety of the use of microprobe array continuous glucose sensor with regards to skin inflammation.|24 hours||||Participants|||Count of Participants
2625872|NCT01908426|Secondary|Objective Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|ORR is measured by radiologic assessment every 8 weeks after randomization until disease progression or discontinuation of study treatment (up to 45 months)|The analysis of ORR was performed in the ITT population (all randomized: 470 cabozantinib, 237 placebo) based upon response determined by Investigator per RECIST 1.1|||Participants|||Count of Participants
2625873|NCT01908426|Secondary|Progression-Free Survival (PFS)|Duration of PFS is defined as the time of randomization to the earlier of the following events, progressive disease as determined by Investigator (per RECIST 1.0, which is defined by a ≥ 20% increase in the sum of the longest diameter of target lesions from baseline) or death due to any cause. A Kaplan- Meier analysis was performed to estimate the median duration.|Up to 45 months|The prespecified primary analysis of PFS was based on the first 707 randomized subjects (470 cabozantinib, 237 placebo).|||months||95% Confidence Interval|Median
2625892|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||µmol/mL||Standard Deviation|Mean
2625874|NCT01908426|Primary|Overall Survival (OS)|The primary analysis of OS is defined as the time from randomization to death from any cause. The analysis was based on a second planned interim analysis prespecified to be performed at approximately the 75% information fraction (ie, at approximately 466 deaths). The data cutoff date for this event-driven analysis in the Intent to Treat (ITT) population was 01 June 2017. Median OS was calculated using the Kaplan-Meier estimates.|Up to 45 months|The ITT population was used and included 707 randomized subjects (470 cabozantinib, 237 placebo) in the second interim analysis with a cutoff date of 01 June 2017.|||months||95% Confidence Interval|Median
2625875|NCT01908140|Secondary|Transition Dyspnoea Index (TDI) Focal Score at Week 24|"The TDI includes the same 3 categories as BDI and 7 ratings indicating the magnitude of the change from baseline in each category: from -3 (major deterioration) to zero (no change) to +3 (major improvement). Category scores are added to compute the Focal Score (from -9 to 9)"|At Week 24|PP population defined as a subset of ITT constituted by patients who met all inclusion/exclusion criteria liable to affect the efficacy ssessment, attained sufficient compliance to treatment and did not present serious deviations of the protocol.|||TDI Focal Score|Participants|Standard Error|Least Squares Mean
2625876|NCT01908140|Primary|Peak Forced Expiratory Volume in One Second (FEV1) at Week 24|Peak FEV1 define at the highest value observed in the 3h after the morning IMP administration|At Week 24|"ITT population: randomized patients who took at least one dose of IMP and have a baseline FEV1 assessment.~PP population: subset of ITT constituted by patients who met all inclusion/exclusion criteria liable to affect the efficacy ssessment, attained sufficient compliance to treatment and did not present serious deviations of the protocol."|||Liters|Participants|Standard Error|Least Squares Mean
2625877|NCT01908127|Secondary|Index of Heart Rate|The heart rate of children was measured before the injection of local anesthesia solution to save a baseline data and it was also measured after the injection to assess the effect of this dental stress.|before and after the injection of local anesthesia solution||||beat per Min||Standard Deviation|Mean
2625878|NCT01908127|Primary|Behaviors of Children|"A video-camera was focused started to record child's behavior. The recorded video tapes were independently evaluated by 2 paediatric dentists who were blind to the grouping of the children. Children's anxiety reactions and cooperative behaviours were scored based on venham scale and Frankle Index ,respectively. quantification was performed at the injection of local anaesthesia and at the beginning of the tooth preparation. An average of both two time points scoring was used.~Table 1: Venham 6-point Index 0 = Relaxed: 1 = Uneasy: 2 = Tense: 3 = Reluctant: 4 = Interference: 5 = Out of contact~Table 2: Frankle 4-point Index~1:Definitely Negative ( uncooperative,Refusal of treatment ) , 2:Negative ( some evidence of negative attitude but not pronounced) , 3:Positive ( Acceptance of treatment, at times cautious) , 4:Definitely Positive( Good rapport with the dentist)"|participants followed for the duration of examination and treatment appointment, an expected average of 3 weeks||||units on a scale||Standard Deviation|Mean
2625879|NCT01908062|Secondary|Participant Safety: Precipitated Withdrawal|Proportion of participants assigned to XR-NTX who develop precipitated opioid withdrawal.|16 weeks||||Participants|||Count of Participants
2625880|NCT01908062|Secondary|Participant Safety: Any Fatal or Non-fatal Overdose Between Baseline and Week 16||16 weeks||||Participants|||Count of Participants
2625881|NCT01908062|Secondary|Number of Participants With Urine Ethyl Glucuronide (EtG) Positive for Alcohol||Baseline and 16 weeks|In both the TAU and XR-NTX groups, reporting results for participants who were retained at 16 weeks and completed necessary study assessments.|||Participants|||Count of Participants
2625882|NCT01908062|Secondary|Mean Days of Alcohol Use in Past 30 Days|Change in 30 day alcohol use by Addiction Severity Index (ASI)-lite self-report and Time-Line Follow Back in the final 30 days of the 16 week trial compared to screening.|Baseline and 16 weeks|In both the TAU and XR-NTX groups, reporting results for participants who were retained at 16 weeks and completed necessary study assessments.|||days||Standard Deviation|Mean
2625883|NCT01908062|Secondary|Number of Participants With Urine Drug Screen (UDS) Positive for Opioids||Baseline and 16 weeks|In both the TAU and XR-NTX groups, reporting results for participants who were retained at 16 weeks and completed necessary study assessments.|||Participants|||Count of Participants
2625884|NCT01908062|Secondary|Participant Safety: Change in Liver Enzymes Between Baseline and Week 16|Change in liver enzymes between screening and Week 16. AST = Aspartate transaminase ALT = Alanine transaminase|Baseline and 16 weeks||||IU/L||Standard Deviation|Mean
2625885|NCT01908062|Secondary|HIV Care Engagement|Change in the proportion of participants prescribed antiretroviral therapy (ART) within 16 weeks following randomization, compared to baseline.|Baseline and 16 weeks||||Participants|||Count of Participants
2625886|NCT01908062|Secondary|Mean Days of Opioid Use in Past 30 Days|Change in 30 day opioid use by Addiction Severity Index (ASI)-lite self-report and Time-Line Follow Back in the final 30 days of the 16 week trial compared to screening.|Baseline and 16 weeks|In both the TAU and XR-NTX groups, reporting results for participants who were retained at 16 weeks and completed necessary study assessments.|||days||Standard Deviation|Mean
2625887|NCT01908062|Secondary|HIV Viral Suppression at 16 Weeks|Plasma HIV viral load of < 200 copies/mL compared with screening|16 weeks|23 TAU participants and 21 XR-NTX participants had a 16-week lab draw for HIV viral load testing.|||Participants|||Count of Participants
2625888|NCT01908062|Primary|Number of Participants Successfully Retained on Pharmacotherapy Treatment at 16 Weeks|Number of participants who received the maximum possible expected doses of XR-NTX, or the full course of recommended pharmacotherapy treatment for treatment as usual (TAU) arm.|16 weeks|24 TAU participants, and 17 XR-NTX participants initiated treatment in their respective arms. Treatment retention is calculated only for subjects who have been initiated onto treatment.|||Participants|||Count of Participants
2625889|NCT01908062|Primary|Number of Participants With Successful Initiation of Treatment Within 4 Weeks of Randomization|Successful induction onto XR-NTX or initiation of treatment as usual within 4 weeks of randomization.|4 weeks||||Participants|||Count of Participants
2625890|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||% of volume||Standard Deviation|Mean
2625891|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||% of volume||Standard Deviation|Mean
2625902|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||mmHg at 37° C||Standard Deviation|Mean
2625903|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||pCO2 (mmHg at 37° C)||Standard Deviation|Mean
2625904|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||pH||Standard Deviation|Mean
2625905|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||pH (at 37° C)||Standard Deviation|Mean
2625906|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||g/dL||Standard Deviation|Mean
2625907|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||g/dL||Standard Deviation|Mean
2625908|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||10E3 cells/µL||Standard Deviation|Mean
2625909|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||10E3 cells/µL||Standard Deviation|Mean
2625910|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||µmol/g Hgb||Standard Deviation|Mean
2625911|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||µmol/g Hgb||Standard Deviation|Mean
2625912|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)||Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||volume % of red blood cells||Standard Deviation|Mean
2625913|NCT01907906|Secondary|In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)||Day 0|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||% of volume||Standard Deviation|Mean
2625914|NCT01907906|Secondary|Neoantigenicity - Day 42 Indirect Antigen Test (IAT)|IAT testing of RBCs via low ionic strength solution (LISS-15), Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded.|Day 42 of Treatment Periods 1 and 2|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 42 of both Treatment Periods 1 and 2.|||Positive results|||Number
2625915|NCT01907906|Secondary|Neoantigenicity - Day 42 Direct Antigen Test (DAT)|DAT testing of RBCs via Anti-IgG and Anti-C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating a new antigen formation) were recorded.|Day 42 of Treatment Periods 1 and 2|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test|||Positive results|||Number
2625916|NCT01907906|Secondary|Neoantigenicity - Day 21 Indirect Antigen Test (IAT)|Day 21 IAT testing of RBCs via LISS-15, Anti-IgG and C3 as derived from Mirasol-treated WB versus untreated WB. Number of positive results (indicating antibody formation to a new antigen) were recorded.|Day 21 of Treatment Periods 1 and 2|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 21 of both Treatment Periods 1 and 2|||Positive results|||Number
2625917|NCT01907906|Secondary|Neoantigenicity - Day 21 Direct Antigen Test (DAT)|DAT testing of Red Blood Cells (RBCs) via Anti-immunoglobulin G (Anti-IgG) and Anti Complement Component 3 (Anti-C3) as derived from Mirasol-treated whole blood (WB) versus untreated WB conducted on Day 21 of both Treatment Periods 1 and 2. Number of positive results (indicating a new antigen formation) were recorded.|Day 21|All subjects who signed an IC Form (were enrolled), and had samples available for the requested test on Day 21 of both Treatment Periods 1 and 2|||Positive results|||Number
2625918|NCT01907906|Secondary|Spearman's Correlation Coefficients: Linear T50 (Days) With pCO2 (mmHg at 37° C)|Spearman's Correlation Coefficients comparing Linear T50 (Days) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|28 days|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.|||Spearman's Correlation Coefficient|||Number
2625919|NCT01907906|Secondary|Spearman's Correlation Coefficients: Linear T50 (Days) With Adenosine Triphosphate (ATP) (µmol/g Hgb)|Spearman's Correlation Coefficients comparing Linear T50 (Days) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|28 days|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.|||Spearman's Correlation Coefficient|||Number
2625920|NCT01907906|Secondary|Spearman's Correlation Coefficients: Linear T50 (Days) With Hemolysis (%)|Spearman's Correlation Coefficients comparing Linear T50 (Days) with each of Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|28 days|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.|||Spearman's Correlation Coefficient|||Number
2625921|NCT01907906|Secondary|Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C)|Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with pCO2 (mmHg at 37° C) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|24 hours|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.|||Spearman's Correlation Coefficient|||Number
2625922|NCT01907906|Secondary|Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb)|Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with ATP (µmol/g Hgb) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|24 hours|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.|||Spearman's Correlation Coefficient|||Number
2625923|NCT01907906|Secondary|Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%)|Spearman's Correlation Coefficients comparing 24-Hour RBC Recovery (%) with Hemolysis (%) in packed Red Blood Cells (pRBCs) derived from Mirasol-treated whole blood (WB) versus pRBCs derived from untreated WB|24 hours|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.|||Spearman's Correlation Coefficient|||Number
2625924|NCT01907906|Secondary|Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival|Assessment of AUC of RBC survival over 28 days for RBCs derived from Mirasol-treated Whole Blood (WB) versus RBCs derived from untreated WB.|28 days|All subjects who signed an IC Form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected within the first 22 min, 30 sec post-infusion in each treatment period.|||Days * Percent Recovery||Standard Deviation|Mean
2625925|NCT01907906|Secondary|Red Blood Cell (RBC) Survival by Product|Assessment of linear & exponential RBC survival and half-life (T50) over 28 days for RBCs derived from Mirasol-treated WB versus RBCs derived from untreated WB.|28 days|All subjects who signed informed consent,were eligible, had no intercurrent illness or notable signs/symptoms in 24 hrs prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had ≥ 4 blood samples collected within the first 22 min 30 sec post-infusion in each treatment period.|||Days||Standard Deviation|Mean
2625926|NCT01907906|Primary|Red Blood Cell (RBC) 24-Hour Recovery|"To evaluate, as per FDA criteria, the 24-hour post transfusion RBC recovery in healthy adult subjects of leuko-reduced packed red blood cells (LR-pRBC) that have been derived from Mirasol-treated fresh WB units and stored at 1 to 6°C for 21 days.~24-hour RBC Recovery is a measure of the % of RBCs that are still functioning 24 hours after they have been reinfused back into the donor following storage over 21 days."|24 hours|All subjects who signed an IC form (were enrolled), met eligibility criteria, had no intercurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had no evidence of neoantigen formation on stored LR-pRBCs, and had at least 4 blood samples collected during the first 22 min, 30 sec post-infusion in each treatment period.|||% 24-hour RBC Recovery||Standard Deviation|Mean
2625927|NCT01907854|Secondary|Number of Treatment Emergent Adverse Events (TEAEs)|A treatment emergent adverse event (TEAE) was defined as an event that had an onset date (or increase in severity) on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. The number of TEAEs was recorded during 26 weeks of treatment plus one week follow-up period.|During 26 weeks of treatment plus one week follow-up period.|Safety analysis set-All randomised subjects receiving at least one dose of any of the trial product.|||number of events|||Number
2625928|NCT01907854|Secondary|Subjects Who Achieve HbA1c Below 7.0% (53 mmol/Mol) (American Diabetes Association Target) (y/n)|Number of subjects who achieve HbA1c <7.0% were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.|After 26 weeks of treatment|FAS-All randomised subjects receiving at least one dose of any of the trial product.|||percentage (%)|||Number
2625929|NCT01907854|Secondary|Change in Systolic Blood Pressure and Diastolic Blood Pressure|Change from baseline in systolic and diastolic blood pressure were analysed after 26 weeks of treatment. Missing values were imputed using MMRM.|From baseline to week 26|FAS - All randomised subjects receiving at least one dose of any of the trial product|||mmHg||Standard Deviation|Mean
2625930|NCT01907854|Secondary|Change in Fasting Blood Lipids|Ratio to baseline in fasting blood lipids (total cholesterol, low density lipoprotein [LDL], very low density lipoprotein [VLDL], high density lipoprotein [HDL], triglycerides, and free fatty acids) were analysed after 26 weeks treatment. Missing values were imputed using MMRM. Here we are presenting ratio to baseline data.|From baseline to week 26|FAS-All randomised subjects receiving at least one dose of any of the trial product. There were missing baseline values for free fatty acids in 1 subject in the liraglutide arm and 6 subjects in the sitagliptin arm.|||ratio||Standard Deviation|Mean
2625931|NCT01907854|Secondary|Change in Fasting Plasma Glucose|Change from baseline in fasting plasma glucose was analysed after 26 weeks of treatment. Missing values were imputed using MMRM.|From baseline to week 26|FAS - All randomised subjects receiving at least one dose of any of the trial product.|||nmol/L||Standard Deviation|Mean
2625932|NCT01907854|Secondary|Change in Body Weight|Change from baseline in body weight was analysed after 26 weeks of treatment. Analysis population set: FAS: all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using MMRM.|From baseline to week 26|FAS - All randomised subjects receiving at least one dose of any of the trial product.|||kg||Standard Deviation|Mean
2626022|NCT01905943|Secondary|Median Time to New Anti-Leukemia Therapy (TTNT)|Kaplan Meier estimate of median TTNT was defined as the time at which half of the participants have initiated a new anti-leukemic therapy.|Baseline until end of study (up to approximately 5 years)|The ITT population was defined as all participants enrolled in the study regardless of whether or not they received any study drug.|||months||95% Confidence Interval|Median
2625933|NCT01907854|Primary|Change in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c was analysed after 26 weeks of treatment. Analysis population set: full analysis set (FAS); all randomised subjects receiving at least one dose of any of the trial products. Missing values were imputed using mixed model for repeated measurements (MMRM).|From baseline to week 26|Full analysis set (FAS) -All randomised subjects receiving at least one dose of any of the trial product.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2625934|NCT01907815|Other Pre-specified|Percentage Change in Cellular Proteins|The 95% confidence interval will be assessed.|Baseline to day 28 post treatment|||||||
2625935|NCT01907815|Other Pre-specified|Maximum Percentage Change in Total and Phospho-proteins|Change in total and phospho-proteins assessed by densitometric quantitative data by western blot analysis, or mean fluorescent intensities by flow cytometry and will be assessed for each patient for all time points and graphically plotted for each dose level.|Baseline to 12 weeks post therapy|||||||
2625936|NCT01907815|Secondary|Time to Progression for Participants Achieving CR/CRp|Time to Progression (TTP) is defined as the length of time from the start of treatment to disease progression as measured in days for participants with complete response.|Up to 12 weeks|Outcome data were not collected and the Outcome will never be analyzed.||||||
2625937|NCT01907815|Secondary|Progression Free Survival of Participants Achieving CR/CRp|Estimated disease-free survival period using the Kaplan-Meier method. Log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.|Up to 12 weeks|No participants achieved CR/CRp therefore analysis not available.||||||
2625938|NCT01907815|Secondary|Overall Survival of Participants Achieving CR/CRp|Estimated using the Kaplan-Meier method. Log-rank test will be performed to test the difference in time-to-event distributions between patient groups. Cox proportional hazards model will be used to include multiple covariates in the time-to-event analysis.|Up to 12 weeks|No participants achieved CR/CRp therefore analysis not available.||||||
2625939|NCT01907815|Secondary|Most Frequently Reported Adverse Events (AE)|National Cancer Institute (NCI) published standardized definitions for adverse events (AEs), known as Common Terminology Criteria for Adverse Events (CTCAE), to describe the severity of organ toxicity for those receiving cancer therapy. Toxicity data is summarized by number of incidents experienced while participants were on study using most frequently reported AEs regardless of grade or relatedness as assessed by CTCAE version 4.0. Toxicity is graded as mild (Grade 1), moderate (Grade 2), severe (Grade 3), or life-threatening (Grade 4), with specific parameters according to the organ system involved. Death (Grade 5) is used for some of the criteria to denote a fatality. For full adverse event reporting see Adverse Event Section. Data collection over first four cycles (16 weeks) of therapy, with evaluation after full cycle of therapy (28 days), continuing AE collection until 28 days following last study drug dose.|AE collected continuously over 28-day cycles and up to 28 days after last dose of study drug.|One participant of the 17 registered in first cohort (Trametinib 2.0) withdrew without treatment and is excluded from adverse event reporting.|||events|||Number
2625940|NCT01907815|Primary|Complete Response Rate (CRR, Defined as CR+CRp) Assessed by AML 2003 Response Criteria|Proportion of participants achieving complete remission (CR) or CR with incomplete recovery of platelets (CRp) as best response within 4 cycles of therapy. Complete Response (CR): Disappearance all clinical &/or radiologic evidence of disease. Neutrophil count ≥ 1.0x10^9/L; Platelet count ≥ 100x109/L; Normal bone marrow differential (≤ 5% blasts); No extra-medullary leukemia. Complete Remission without Platelet Recovery (CRp): Peripheral blood & bone marrow results as for CR, but platelet counts of < 100x10^9/L. Partial Remission (PR): Blood count recovery as for CR, but decrease of at least 50% in % marrow blasts to >5% to 25% in bone marrow aspirate. Morphologic leukemia-free state: Normal marrow differential (<5% blasts); neutrophil & platelet counts not considered.95% confidence interval will be estimated for the combination regimen.|First four cycles (16 weeks) of therapy, with evaluation after one full cycle of therapy (28 days) and up to 16 weeks for response|One participant in first cohort withdrew prior to treatment therefore excluded from study analysis.|||percentage of participants|||Number
2625941|NCT01907737|Primary|Active Range of Motion of Wrist Extension in the Paretic Side|In this cross-over study, the primary outcome was measured immediately before and after each session of treatment. In each session, one of the four possible interventions was administered.|Pre- and post-intervention on each intervention day|Of twenty two participants who started the study, one participant only participated in one of the four sessions, while the remainder participated in all four. Of the 21 participants who completed four sessions, one was removed from analyses after meeting exclusion criteria|||degrees||Standard Deviation|Mean
2625942|NCT01907516|Secondary|Subject Satisfaction|Satisfaction was measured with a survey after completing using both reporting methods|6 weeks||||percentage of participants|||Number
2625943|NCT01907516|Primary|Compliance With Home Blood Glucose Reporting|Compliance was calculated as a percentage for each method (Confidant or Voicemail) by dividing the total number of reported glucose readings among all participants by the total number of expected readings (4 daily) over the 6 week study time period. Women with gestational diabetes are instructed to monitor their glucose 4 times per day.|6 weeks||||percentage of expected glucose tests|||Number
2625944|NCT01907490|Secondary|PK Parameters: AUC(0-8)|Area under the concentration-time curve of Ha44 (AUC 0-8)|0-8 hours|PK Population|||ng.h/mL||Full Range|Mean
2625945|NCT01907490|Secondary|PK Parameters: Tmax|Time to maximum concentration of Ha44 (Tmax)|0-8 hours|PK population|||hours||Full Range|Median
2625946|NCT01907490|Secondary|Pk Parameters: Cmax|Maximum concentration of Ha44 (Cmax)|0 to 8 hours|Pharmacokinetic (PK) population included subjects who had sufficient concentration-time profiles for PK analyses.|||ng/mL||Full Range|Mean
2625947|NCT01907490|Primary|Number of the Subjects With AEs.|Safety and tolerability assessed by AEs. Number of subjects with reporting AEs.|3 months|paediatric population, children between ages 6 months to <18 years.|||participants|||Number
2625948|NCT01907334|Primary|Total Airway Resistance Increase|concentration of methacholine required to increase total airway resistance by 40% (PC40R5)|1 to 7 days|The analysis was performed on all 10 participants.|||ln(mg/mL)||95% Confidence Interval|Geometric Mean
2625949|NCT01907321|Secondary|Cough Expiratory Airflow|Cough airflow measure of peak expiratory flow rate|Change in baseline to 7 weeks|14 adults with a history of ischemic stroke in the previous 2 years. All but two participants (1 male, 1 female) completed the protocol.|||Liters of air/second||Standard Deviation|Mean
2625950|NCT01907321|Primary|Maximum Expiratory Pressure|This measure will indicate if there are strength gains in the respiratory muscle by measuring expiratory pressure generating ability.|Change in baseline to week 7|Data from 14 adults with a history of ischemic stroke was analyzed for changes in maximum expiratory pressure generating capacity, cough strength, and swallowing safety. All but 2 participants (1 male, 1 female) completed the protocol. Intent to treat analysis was used.|||cm H2O (pressure measurement)||Standard Deviation|Mean
2625951|NCT01907269|Other Pre-specified|Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care||6 and 18 months post-intervention|For the Intent-to-Treat Analysis the data was imputed for non-responders.|||Participants|||Count of Participants
2625952|NCT01907269|Secondary|Number of Participants That Initiate an Osteoporosis Prescription Medication|We will assess the number of participants that self-report the initiation of an osteoporosis prescription medication. It will be assessed using a self-completed survey. Osteoporosis prescription medications that will be assessed include: alendronate, calcitonin, denosumab ibandronate, raloxifene, risedronate, teriparatide, and zoledronic acid. We will not include initiation of estrogen hormone therapies as part of the outcome.|18 months||||Participants|||Count of Participants
2625953|NCT01907269|Secondary|Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing|Self-report of a receipt of a DXA scan (Bone Mineral Density test).|6 and 18 months post-intervention|For the Intent-to-Treat Analysis the data was imputed for non-responders. Surveys for BMD (18 months) included 3 responses. If participants marked option (2) that they had received a BMD, but > 12 months ago they were excluded from analyses. Thus our overall population analyzed (those marking response 1 or 3) is different than our participant flow.|||Participants|||Count of Participants
2625954|NCT01907269|Secondary|Number of Participants Who Reported Use of Calcium and Vitamin D|We will assess the use of calcium and vitamin D by participant. This will be assessed on a self-completed survey. Participants will be asked if they are currently taking a calcium supplement and/or vitamin D supplement.|6 and 18 months post-intervention|For the Intent-to-Treat Analysis the data was imputed for non-responders.|||Participants|||Count of Participants
2625955|NCT01907269|Primary|Number of Participants That Initiate an Osteoporosis Prescription Medication|We will assess the number of participants that self-report the initiation of an osteoporosis prescription medication. It will be assessed using a self-completed survey. Osteoporosis prescription medications that will be assessed include: alendronate, calcitonin, denosumab ibandronate, raloxifene, risedronate, teriparatide, and zoledronic acid. We will not include initiation of estrogen hormone therapies as part of the primary outcome.|6 months post-intervention|For the Intent-to-Treat Analysis the data was imputed for non-responders.|||Participants|||Count of Participants
2625956|NCT01907217|Secondary|Columbia Autobiographical Memory Interview-Short Form (AMI-SF)|The AMI-SF is used to assess retrospective autobiographical memory function. It has six categories, which involve five questions each, about a family member, most recent travel, last New Year's Eve, last birthday, most recent employment and last visit to a doctor for a physical complaint. At baseline interviewers encourage the participant to recall as much information as they can. Responses at baseline can be scored either two points, for a recognisable real memory, or zero for no memory or too little information to constitute a proper memory. Only those questions for which a memory had been retrieved at baseline are examined at follow-up. Follow-up assessments are scored as percentage recall of baseline score, which is scored as 100% irrespective of actual performance..|6 months follow-up|Not all patients completed this cognitive task.|||% of baseline performance||Standard Deviation|Mean
2625957|NCT01907217|Secondary|Columbia Autobiographical Memory Interview-Short Form (AMI-SF)|The AMI-SF is used to assess retrospective autobiographical memory function. It has six categories, which involve five questions each, about a family member, most recent travel, last New Year's Eve, last birthday, most recent employment and last visit to a doctor for a physical complaint. At baseline interviewers encourage the participant to recall as much information as they can. Responses at baseline can be scored either two points, for a recognisable real memory, or zero for no memory or too little information to constitute a proper memory. Only those questions for which a memory had been retrieved at baseline are examined at follow-up. Follow-up assessments are scored as percentage recall of baseline score, which is scored as 100% irrespective of actual performance..|3 months follow-up|Not all patients completed this cognitive task.|||% of baseline performance||Standard Deviation|Mean
2625958|NCT01907217|Secondary|Columbia Autobiographical Memory Interview-Short Form (AMI-SF)|The AMI-SF is used to assess retrospective autobiographical memory function. It has six categories, which involve five questions each, about a family member, most recent travel, last New Year's Eve, last birthday, most recent employment and last visit to a doctor for a physical complaint. At baseline interviewers encourage the participant to recall as much information as they can. Responses at baseline can be scored either two points, for a recognisable real memory, or zero for no memory or too little information to constitute a proper memory. Only those questions for which a memory had been retrieved at baseline are examined at follow-up. Follow-up assessments are scored as percentage recall of baseline score, which is scored as 100% irrespective of actual performance..|end of allocated ECT course|Not all patients completed this cognitive task.|||% of baseline performance||Standard Deviation|Mean
2625959|NCT01907217|Primary|Hamilton Depression Rating Scale (HDRS)|The HDRS was originally designed to assess severity of depressive symptoms in patients with a primary depressive illness and is now the most commonly used measure of depression severity. It was first published in a 17-item format with the optional addition of 4 items making up the 21-item version. In addition to the original 21 items, the 24-item HDRS includes items on helplessness, hopelessness and worthlessness; its score range is 0-77, with higher scores reflecting greater burden of depressive symptoms.|HDRS scores were obtained at baseline, end of allocated ECT treatment, and at 3 and 6 month follow-up timepoints.|Intention to treat analysis.|||units on a scale||Standard Deviation|Mean
2625960|NCT01907113|Secondary|Assessment of Tolerability by Investigator|Tolerability was assessed by the investigator based on adverse events and the laboratory evaluation.|Drug administration until end-of-study-examination, 5 days|Treated set|||participants|||Number
2625961|NCT01907113|Secondary|Safety: Physical Examination, Vital Signs, ECG and Laboratory Measurements|Number of participants with clinically relevant findings in physical examination, Vital Signs, Clinically Significant Abnormalities in Electrocardiogram (ECG) and Significant Changes from Baseline Laboratory Measurements|Drug administration until end-of-study-examination, 5 days|Treated set|||participants|||Number
2625962|NCT01907113|Secondary|Total Urinary Glucose Excretion (UGE)|Change from baseline in total urinary glucose excretion|24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration (Interval 24-0 h before drug administration only for baseline UGE)|The UGE analysis set included all patients in the treated set who provided the baseline value from 0 to 24 hours before drug administration and the value for urinary glucose excretion from 0 to 24 hours after drug administration without important protocol violations relevant to the evaluation of Pharmacodynamics.|||mg||Standard Error|Mean
2625963|NCT01907113|Secondary|Plasma Protein Binding|"Plasma protein binding is the percent of analyte binding to the plasma protein, pre-dose plasma samples were spiked with Empa 1000 nmol/L.~The standard deviation is actually the coefficient of variation."|1 h before drug administration and 1:30 and 3:00 h after drug administration|PKS|||percentage of plasma protein binding||Standard Deviation|Mean
2625964|NCT01907113|Secondary|%AUCtz-∞ (Percentage of Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From the Time of the Last Quantifiable Data Point Extrapolated to Infinity)|Percentage of area under the concentration-time curve of the analyte in plasma over the time interval from the time of the last quantifiable data point extrapolated to infinity|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS|||percent||Geometric Coefficient of Variation|Geometric Mean
2625965|NCT01907113|Secondary|Renal Clearance of the Analyte in Plasma After Extravascular Administration|Renal Clearance of the Analyte in Plasma After Extravascular Administration for time interval 0-96 hours.|24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration|PKS|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2625966|NCT01907113|Secondary|fe0-96 (Fraction of Analyte Excreted Unchanged in Urine From Time Points 0 to 96 Hours)|Fraction of analyte excreted unchanged in urine from time point 0-96 hours.|24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration|PKS|||percentage of analyte||Geometric Coefficient of Variation|Geometric Mean
2625967|NCT01907113|Secondary|Ae0-96 (Amount of Analyte That is Eliminated in Urine Over the Time Interval 0 to 96 h)|Amount of analyte that is eliminated in urine over the time interval 0-96 hours.|24-0 h before drug administration and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours after drug administration|PKS|||nmol||Geometric Coefficient of Variation|Geometric Mean
2625968|NCT01907113|Secondary|AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point. The areas under the curve were calculated using the linear up/log down algorithm. If a drug concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was used. If the drug concentration was smaller than the preceding concentration, the logarithmic method was used.|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2625969|NCT01907113|Secondary|Apparent Volume of Distribution During the Terminal Phase Lz|Apparent volume of distribution during the terminal phase Lz|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS|||L||Geometric Coefficient of Variation|Geometric Mean
2625970|NCT01907113|Secondary|Apparent Clearance of the Analyte in the Plasma After Extravascular Administration|Apparent clearance of the analyte in the plasma after extravascular administration|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2625971|NCT01907113|Secondary|Terminal Rate Constant in Plasma|Terminal rate constant in plasma (Lz)|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS|||1/h||Geometric Coefficient of Variation|Geometric Mean
2625972|NCT01907113|Secondary|Half-life and Mean Residence Time of the Analyte in Plasma|Terminal half-life of Empagliflozin (t1/2) and Mean residence time of Empagliflozin in the body|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS|||h||Geometric Coefficient of Variation|Geometric Mean
2625973|NCT01907113|Secondary|Time to Maximum Concentration of the Analyte in Plasma|Time from last dosing to maximum concentration of Empagliflozin in plasma (tmax)|1 h before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS|||h||Full Range|Median
2625974|NCT01907113|Primary|Cmax (Maximum Concentration of the Analyte in Plasma)|Maximum concentration of Empagliflozin in plasma|1 hour (h) before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|PKS|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2625975|NCT01907113|Primary|AUC0-∞ (Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 to Infinity)|Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity. The areas under the curve were calculated using the linear up/log down algorithm. If a drug concentration was equal to or higher than the preceding concentration, the linear trapezoidal method was used. If the drug concentration was smaller than the preceding concentration, the logarithmic method was used.|1 hour (h) before drug administration and 0:20, 0:40, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 36:00. 48:00, 72:00, 96:00 h after drug administration|The PK analysis set (PKS) included all evaluable patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2626023|NCT01905943|Secondary|Median Time to Overall Survival (OS)|Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death.|Baseline until death (Approximately up to 5 years)|The ITT population was defined as all participants enrolled in the study regardless of whether or not they received any study drug.|||months||95% Confidence Interval|Median
2625976|NCT01907100|Secondary|Disease Control According to Modified RECIST− Investigator Assessment|"Disease control (best overall response of confirmed CR or PR, or Stable Disease (SD) that lasted ≥36 days) according to modified RECIST.~Percentage of Patients with Disease control is presented. This endpoint was only evaluated for Phase III part."|Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months|Randomised Set: This patient set included all randomized patients.|||Percentage of participants||95% Confidence Interval|Number
2625977|NCT01907100|Secondary|Objective Response According to Modified RECIST− Investigator Assessment|"Objective response (best overall tumour response of confirmed complete response [CR] or confirmed partial response [PR]).~Complete Response: disappearance of all target lesions Partial Response: at least a 30 % decrease in the total tumour measurement of target lesions, taking as reference the baseline total tumour measurement.~Percentage of Patients with confirmed objective response is presented. This endpoint was only evaluated for Phase III part."|Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months|Randomised Set: This patient set included all randomized patients.|||Percentage of participants||95% Confidence Interval|Number
2625978|NCT01907100|Secondary|Overall Survival (OS)|"Overall survival was defined as the duration of time from randomization to time of death.~This is the key secondary endpoint of the trial."|From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months)|Randomised Set: This patient set included all randomized patients.|||Months||Inter-Quartile Range|Median
2625979|NCT01907100|Primary|Progression-Free Survival (PFS)|This outcome measure presents progression-free survival. Disease progression was defined according to the modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occurred first. For patients with known date of progression (or death): PFS (days) = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS (days, censored) = date of last imaging showing no progression - date randomization + 1 day.|From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months)|Randomised Set: This patient set included all randomized patients.|||Months||Inter-Quartile Range|Median
2625980|NCT01907087|Secondary|Percentage Change From Baseline of Magnetic Resonance Imaging (MRI) at Week 49 During 300 mg Dosing Period: Whole Brain Apparent Diffusion Coefficient|Percentage changes in whole brain apparent diffusion coefficient from the ITT population for the 300 mg dosing period|Baseline, Week 49|ITT Population|||percentage change from baseline||Standard Deviation|Mean
2625981|NCT01907087|Secondary|Percentage Change From Baseline of Magnetic Resonance Imaging (MRI) at Week 49 During 300 mg Dosing Period: Volume of Cerebrospinal Fluid|Percentage changes in volume of cerebrospinal fluid from the ITT population for the 300 mg dosing period|Baseline, Week 49|ITT Population|||percentage change from baseline||Standard Deviation|Mean
2625982|NCT01907087|Secondary|Percentage Change From Baseline of Magnetic Resonance Imaging (MRI) at Week 49 During 300 mg Dosing Period: Total White Matter Volume|Percentage changes in total white matter volume from the ITT population for the 300 mg dosing period|Baseline, Week 49|ITT Population|||percentage change from baseline||Standard Deviation|Mean
2625983|NCT01907087|Secondary|Percentage Change From Baseline of Magnetic Resonance Imaging (MRI) at Week 49 During 300 mg Dosing Period: Volume of Total Grey Matter|Percentage changes in volume of total grey matter from the ITT population for the 300 mg dosing period|Baseline, Week 49|ITT Population|||percentage change from baseline||Standard Deviation|Mean
2625984|NCT01907087|Secondary|Percentage Change From Baseline of Magnetic Resonance Imaging (MRI) at Week 49 During 300 mg Dosing Period: Whole Brain Volume|Percentage changes in whole brain volume from the ITT population for the 300 mg dosing period|Baseline, Week 49|ITT Population|||percentage change from baseline||Standard Deviation|Mean
2625985|NCT01907087|Primary|Motor-Language (ML) Scale Score During 300 mg Dosing Period|The progression of ceroid lipofuscinosis (CLN2) disease was assessed using adapted motor and language domains of the Hamburg rating scale (ML scale score). Motor and Language are each 0 - 3 point subscales in which 3 represents best function and 0 represents loss of function. The sum of the motor and language scores (ML score, 0-6 points) was used to evaluate the loss of function.|Baseline, Week 49/Last Assessment|Intent to Treat (ITT) Population : all study subjects receiving > 1 dose|||units on a scale||Standard Deviation|Mean
2625986|NCT01906866|Secondary|The Following Vital Signs Will be Measured: Blood Pressure, Pulse, Breathing and Body Temperature. They Will be Compared Between the Circadin and Placebo Groups.||up to 2.5 years|||||||
2625987|NCT01906866|Secondary|Safety and Tolerability Throughout the Study Will be Measured for the Circadin 2/5 mg and Placebo Throughout the Study Using AE Eliciting Method Treatment Emergent Signs and Symptoms (TESS)|Questionnaire|up to 2.5 years|||||||
2625988|NCT01906866|Secondary|Sleep Parameters (Rest/Activity Cycles) Will be Measured for the Circadin 2/5 mg and Placebo as Measured by Actigraphy After 13 Weeks of Double-blind Treatment.|The Actigraph will be worn on the wrist at night and collect the Sleep parameters|up to 1.5 years|||||||
2625989|NCT01906866|Secondary|The Number of Dropouts Between Circadin 2/5 mg to That of Placebo Will be Compared During the 13 Weeks of Double-blind Treatment.||up to 1.5 years|||||||
2625990|NCT01906866|Secondary|The Children's Behavior at Home, in School, and Community Will be Measured for the Circadin 2/5 mg and Placebo by the Strength of Difficulties Questionnaire (SDQ) Questionnaire Filled Out by the Parents After 13 Weeks of Double-blind Treatment.|Questionnaire|up to 1.5 years|||||||
2625991|NCT01906866|Secondary|The Children's Social Functioning at Home, in School, and Community Settings Will be Measured for the Circadin 2/5 mg and Placebo by the Children Global Assessment Scale (CGAS) Questionnaire After 13 Weeks of Double-blind Treatment.|Questionnaire|up to 1.5 years|||||||
2625992|NCT01906866|Secondary|The Duration of the Longest Sleep Period Will be Measured for the Circadin 2/5 mg and Placebo by a Sleep and Nap Diary After 13 Weeks of Double-blind Treatment.|Questionnaire|up to 1.5 Years|||||||
2625995|NCT01906866|Secondary|Sleep Latency Will be Measured for the Circadin 2/5 mg and Placebo by a Sleep and Nap Diary After 13 Weeks of Double-blind Treatment.|questionnaire - To compare the treatment effect of Circadin® 2/5 mg minitablets to that of placebo on sleep latency as derived from a Sleep and Nap Diary after 13 weeks of double-blind treatment|13 weeks|All patients in the Safety Analysis Set who satisfied all major entry criteria (I.Criteria 1-5) and who had a valid mean TST result recorded for baseline and at least one post-baseline period assessment during the double blind phase. Patients were classified according to randomized treatment. This analysis set was used for all efficacy analyses|||minutes||Standard Error|Mean
2625996|NCT01906866|Primary|The Total Sleep Time Will be Measured for the Circadin 2/5 mg and Placebo by a Sleep and Nap Diary Questionnaire After the 13 Week, Double-blind Treatment Period.|Total Sleep Time - To compare the treatment effect of Circadin® 2/5 mg minitablets to that of placebo on total sleep time (TST) as assessed by the Sleep and Nap Diary after 13 weeks of double-blind treatment|13 weeks|All patients in the Safety Analysis Set who satisfied all major entry criteria (I.Criteria 1-5) and who had a valid mean TST result recorded for baseline and at least one post-baseline period assessment during the double blind phase. Patients were classified according to randomized treatment. This analysis set was used for all efficacy analyses|||minutes||95% Confidence Interval|Mean
2625997|NCT01906658|Secondary|Proportion of Subjects With Treatment Emergent Suicidality||Baseline to Week 36||||Participants|||Count of Participants
2625998|NCT01906658|Secondary|Proportion of Subjects With Adverse Events That Could Not be Controlled by Concomitant Medication||Baseline to Week 8||||Participants|||Count of Participants
2625999|NCT01906658|Secondary|Proportion of Subjects With Adverse Events That Required Study Drug Discontinuation||Baseline to Week 8||||Participants|||Count of Participants
2626000|NCT01906658|Primary|Proportion of Subjects With Adverse Events (AEs) That Required Study Drug Discontinuation or Could Not be Controlled With Concomitant Medication||Baseline to Week 8||||Participants|||Count of Participants
2626001|NCT01906515|Primary|The Effect of SpHb on Transfusion Timeline|Length of time it takes to initiate a RBC transfusion after the need was first established.|During surgery (an average of about 4 hours)|We only included the participants who received a blood transfusion during the surgery for this analysis. Participants who did not receive a transfusion were excluded from this analysis.|||minutes||95% Confidence Interval|Mean
2626002|NCT01906515|Primary|RBC Transfusions Per Subject Receiving a Transfusion|Determine whether using SpHb can affect the quantity of RBC transfused, per patient receiving a transfusion.|During surgery (an average of about 4 hours)|We only included the participants who received a blood transfusion during the surgery for this analysis. Participants who did not receive a transfusion were excluded from this analysis.|||units||95% Confidence Interval|Mean
2626003|NCT01906515|Other Pre-specified|Potential Cost Savings|Potential cost saving resulting from reduced RBC utilization was estimated using activity-based cost estimates established by Shander et al.(8) which determined from both U.S. and European hospitals the total cost of transfusing one RBC unit to be between $522 and $1,183 with a mean and standard deviation of $761 ± $294.|During surgery (an average of about 4 hours)|||||||
2626004|NCT01906515|Secondary|SpHb Absolute and Trend Accuracy|To assess absolute accuracy, or single point comparison, paired SpHb and Hb measurements were compared pre- and post- transfusion and bias and standard deviation were calculated. A Bland Altman graph with limits of agreement (1.96 x standard deviation, adjusted for the bias) was plotted to show agreement across the range of values. To assess trending, a regression plot of changes in Hb and corresponding changes in SpHb was plotted and a coefficient of determination (R2) was calculated|During surgery (an average of about 4 hours)|||||||
2626005|NCT01906476|Primary|Cost-Effectiveness|Measure the ratio of the difference in costs and difference in effectiveness between the two groups, Stepped care minus Telephone Cognitive Behavior Therapy. Below are reported individual cost means and standard deviations for therapist costs during study.|Baseline to end of treatment|All randomized participants|||dollars||Standard Deviation|Mean
2626006|NCT01906476|Primary|Depression|To measure changes in the Quick Inventory of Depressive Symptomatology (QIDS) over time. The QIDS is made up of 16 items and has a possible range of scores of 0 to 27. Higher scores represent worse outcomes.|Baseline, midtreatment, end of treatment, 3 month post treatment, and 6 month post-treatment follow-up|Participants with at least one followup visit which recorded the QIDS post baseline|||units on a scale||Standard Error|Least Squares Mean
2626007|NCT01906372|Secondary|Steroid-sparing Effect of H.P. Acthar Gel in Refractory Adult PM and DM Patients.|Mean change in glucocorticoid dose (equivalent prednisone dose) at 24 weeks compared to baseline.|Steroid sparing effect and safety and tolerability at 24 weeks compared to baseline||||mg||Standard Deviation|Mean
2626008|NCT01906372|Primary|Specific Aim 1: Number of Subjects Meeting IMACS Preliminary Definition of Improvement (DOI).|3 of any of the 6 core set measures (CSM) improved by ≥ 20%, with no more than 2 CSM worsening by ≥25% (worsening measure cannot include the MMT). The DOI should be met at least once on any of the 6 follow up visits and maintained until week 24. Subjects not meeting DOI during the trial are treatment failures.|Primary end point: IMACS preliminary definition of improvement (DOI)|Total of 10 PM/DM patients completed the study.One additional patient dropped out of the study at 6 weeks due to worsening of conduction abnormalities (heart block unrelated to the study drug).The patient had not completed minimum 8 weeks of study drug required for outcome assessment as per study protocol, and was not included in primary analysis.|||Participants|||Count of Participants
2626009|NCT01906346|Primary|The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative|The reinforcing effects of cocaine were determined using a modified progressive ratio procedure in which subjects made 9 choices between each available cocaine dose and one of three money alternatives.|9 choice trials per cocaine dose level with each trial separated by 30 minutes||||cocaine choices||Standard Error|Mean
2626055|NCT01905540|Primary|Maximum Plasma Concentration (Cmax) of SSP-004184 After One Dose|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng/mL||Standard Deviation|Mean
2626010|NCT01906008|Secondary|Average Area Under the Curve (AUC) for Fatigue Over 4 Months|AUC for MDASI-fatigue . Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference. For this study, the sub scale is the average of the 2 preselected items namely, numbness/tingling and fatigue. This subscale ranges from 0 to 10. The primary outcome is the average of the 120 -day area (4 months) under the curve for the sub scale. AUC ranges from 0 (0*120) to 1200 (10*120). To put this into perspective, the average AUC of 103.5 can also be thought of as an average daily AUC of 0.86 ( 103.5/120) on a 0 to 10 scale over the 120-day study period. Lower values represent better outcome while higher values represent worse outcome.|Baseline to 4 months||||Units on a scale *days||Standard Deviation|Mean
2626011|NCT01906008|Primary|Average Area Under the Curve (AUC) for Numbness/Tingling Over 4 Months|AUC for MDASI-numbness/tingling . Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference. For this study, the sub scale is the average of the 2 preselected items namely, numbness/tingling and fatigue. This subscale ranges from 0 to 10. The primary outcome is the average of the 120 -day area (4 months) under the curve for the sub scale. AUC ranges from 0 (0*120) to 1200 (10*120). To put this into perspective, the average AUC of 103.5 can also be thought of as an average daily AUC of 0.86 ( 103.5/120) on a 0 to 10 scale over the 120-day study period. Lower values represent better outcome while higher values represent worse outcome.|Baseline to 4 months||||Units on a scale *days||Standard Deviation|Mean
2626012|NCT01905956|Secondary|Global Evaluation of Safety by the Subjects||12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.|||subjects|||Number
2626013|NCT01905956|Secondary|Global Evaluation of Safety by the Investigators||12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.|||subjects|||Number
2626014|NCT01905956|Secondary|Global Evaluation of Efficacy by the Subjects||12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.|||subjects|||Number
2626015|NCT01905956|Secondary|Global Evaluation of Efficacy by the Investigators||12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the questions for the assessment. However, missing data still appeared.|||subjects|||Number
2626016|NCT01905956|Secondary|Food Craving Questionnaire (FCQ)|"This validated questionnaire evaluates changes in food cravings. It contains 15 items and was completed by the subjects based on the momentary feeling at the study site during visits 2 to 5 (Baseline and week 4, 8 and 12). Assessment was based on the following 5-point Likert scale:~= I do not agree at all~= I do not agree~= Neutral~= I agree~= I highly agree~Results were expressed as the mean score for the whole population in the respective intervention group."|Baseline and 4, 8, and 12 weeks|The analysis is performed for all subjects of the Intention-to-treat population who answered the FCQ at all visits from v2 to v5. Missing data were appeared in 9 cases at visit v5 and additional in 8 cases at visit v4.|||Units on a scale||Standard Deviation|Mean
2626017|NCT01905956|Secondary|Mean Change in Body Fat Mass (kg) From Baseline to Week 12|"Body fat mass kg) was measured by bio-impedance method using validated electronic weighing scales (Tanita BC-420 SMA).~Results were reported as value at baseline minus value at week-12, ie. reduction of body fat mass kg) (positive values)."|Baseline and 12 weeks|Analysis of body fat was not performed for 1 subject (placebo) due to missing data from Visit 2 - Visit 5. At Visit 1, analysis was performed for 109 subjects only. As such, short of 1 baseline date.|||kilogram (kg)||Standard Deviation|Mean
2626018|NCT01905956|Secondary|Mean Change in Body Fat Content (%) From Baseline to Week 12|"Body fat content (%) was measured by bio-impedance method using validated electronic weighing scales (Tanita BC-420 SMA).~Results were reported as value at baseline minus value at week-12, ie. reduction of body fat content (%) (positive values)."|Baseline and 12 weeks|Analysis of body fat was not performed for 1 subject (placebo) due to missing data from Visit 2 - Visit 5. At Visit 1, analysis was performed for 109 subjects only. As such, short of 1 baseline date.|||Percentage of body fat (%)||Standard Deviation|Mean
2626019|NCT01905956|Secondary|Mean Change in Waist and Hip Circumference (cm) From Baseline to Week 12|"Waist circumference (cm) was measured at the level midway between the lateral lower rib margin and the iliac crest.~Hip circumference (cm) was measured as the maximal circumference over the buttocks.~Results were reported as value at baseline minus value at week-12, ie. amount of waist and hip circumference reduction (cm) (positive values)."|Baseline and 12 weeks||||centimetre (cm)||Standard Deviation|Mean
2626020|NCT01905956|Primary|Mean Change in Body Weight From Baseline to Week 12|"Body weight (kg) was measured in subjects wearing underwear and no shoes using calibrated weighing scales (Tanita BC-420 SMA).~Results were reported as value at baseline minus value at week-12, ie. amount of weight loss in (kg) (positive values)."|Baseline and 12 weeks||||kilogram (kg)||Standard Deviation|Mean
2626021|NCT01905943|Secondary|Median Time to Duration of Response (DoR)|Kaplan Meier estimate of median DoR was defined as the time at which half of the responding (PR or CR) participants had progressed (PD) or died from any cause, whichever occurred first. PR: >/= 50% decrease in peripheral blood lymphocyte count AND >/= 50% reduction in lymphadenopathy OR >/= 50% reduction of liver enlargement OR >/= 50% reduction of spleen PLUS one of the following: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L OR >/= 50% increase in neutrophils, platelets or hemoglobin. CR: Peripheral blood lymphocytes 4,000/mcL, no significant lymphadenopathy, no hepatomegaly and splenomegaly, no disease symptoms, blood counts: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L and bone marrow normocellular for age. PD: as defined in the description for Event-Free Survival outcome measure.|Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years)|The ITT population was defined as all participants enrolled in the study regardless of whether or not they received any study drug. Number of participants analyzed indicates participants who took part in the analysis.|||months||95% Confidence Interval|Median
2626091|NCT01904526|Secondary|Systolic Blood Pressure|Evaluate the safety and tolerability of guanfacine by measuring physiologic reactivity (e.g., systolic blood pressure)|Last day of titration period 1 (Day 21) to the last day of titration period 3 (Day 57)|Last day of titration period: 3 mg/day IR (Day 21) followed by 4 mg/kg ER (Day 48) followed by 6 mg/day ER (Day 57)|||mmHg||Standard Error|Mean
2626024|NCT01905943|Secondary|Median Time to Event-Free Survival (EFS)|Kaplan Meier estimate of median EFS is the time at which half of the participants have progressed as assessed by investigator based on IWCLL tumor response criteria, or have initiated a non-protocol-specified anti-leukemia therapy or died, whichever occurs first. PD: at least 1 of the following: >/= 50% increase in absolute number of circulating lymphocytes to at least 5,000/mcL, appearance of new palpable lymph nodes, >/= 50% increase in longest diameter of any previous site of clinically significant lymphadenopathy, >/= 50% increase in enlargement of liver and/or spleen, transformation to more aggressive histology, progression of any cytopenia, decrease of hemoglobin levels by more than 20 g/L or to less than 100 g/L, decrease of platelet counts by more than 50% or to less than 100,000 /mcL, decrease of neutrophil counts by more than 50% or to less than 1,000/mcL.|Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years)|The ITT population was defined as all participants enrolled in the study regardless of whether or not they received any study drug.|||months||95% Confidence Interval|Median
2626025|NCT01905943|Secondary|Median Time to Response (TTR)|Kaplan Meier estimate of median TTR was defined as the time at which half of the participants reached CR or PR based on IWCLL tumor response criteria. CR: Peripheral blood lymphocytes 4,000/mcL, no significant lymphadenopathy, no hepatomegaly and splenomegaly, no disease symptoms, blood counts: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L and bone marrow normocellular for age. PR: >/= 50% decrease in peripheral blood lymphocyte count AND >/= 50% reduction in lymphadenopathy OR >/= 50% reduction of liver enlargement OR >/= 50% reduction of spleen PLUS one of the following: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L OR >/= 50% increase in neutrophils, platelets or hemoglobin.|Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years)|The ITT population was defined as all participants enrolled in the study regardless of whether or not they received any study drug.|||months||95% Confidence Interval|Median
2626026|NCT01905943|Secondary|Median Time to Progression-Free Survival (PFS)|Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease [PD]) based on IWCLL tumor response criteria or died from any cause, whichever occurred first. PD: at least one of the following: >/= 50% increase in the absolute number of circulating lymphocytes to at least 5,000/mcL, appearance of new palpable lymph nodes, >/= 50% increase in the longest diameter of any previous site of clinically significant lymphadenopathy, >/= 50% increase in the enlargement of the liver and/or spleen, transformation to more aggressive histology, progression of any cytopenia, decrease of hemoglobin levels by more than 20 g/L or to less than 100 g/L, decrease of platelet counts by more than 50% or to less than 100,000 /mcL, decrease of neutrophil counts by more than 50% or to less than 1,000/mcL.|Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years)|The ITT population was defined as all participants enrolled in the study regardless of whether or not they received any study drug.|||months||95% Confidence Interval|Median
2626027|NCT01905943|Secondary|Percentage of Participants With Best Overall Response (BOR)|BOR was defined as the percentage of participants with the best response obtained throughout the trial with CR, CRi, or PR, as determined by the investigator based on IWCLL tumor response criteria. CR: Peripheral blood lymphocytes 4,000/mcL, no significant lymphadenopathy, no hepatomegaly and splenomegaly, no disease symptoms, blood counts: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L and bone marrow normocellular for age. Cri: CR with persistent cytopenia. PR: >/= 50% decrease in peripheral blood lymphocyte count AND >/= 50% reduction in lymphadenopathy OR >/= 50% reduction of liver enlargement OR >/= 50% reduction of spleen PLUS one of the following: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L OR >/= 50% increase in neutrophils, platelets or hemoglobin.|Baseline, Day 85, end of treatment or early termination, and follow-up, assessed up to disease progression or death, whichever occurs first (up to approximately 5 years)|The ITT population was defined as all participants enrolled in the study regardless of whether or not they received any study drug.|||percentage of participants||95% Confidence Interval|Number
2626028|NCT01905943|Secondary|Percentage of Participants With Minimal Residual Disease (MRD)-Negativity as Assessed by Flow Cytometry|MRD-negativity was defined as the presence of less than 1 chronic lymphocytic leukemia (CLL) cell per 10,000 leukocytes in blood and bone marrow as assessed by flow cytometry 3 months after last dose of study treatment (i.e. at final response assessment [FRA] visit).|3 months after the last dose of study treatment (up to approximately 5 years)|The intent-to-ship (ITS) population included all participants from the ITT population whose MRD samples at the FRA could be shipped to the central laboratory within 48 hours.|||percentage of participants|||Number
2626029|NCT01905943|Secondary|Percentage of Participants With Overall Response (OR) at Final Response Assessment (FRA)|OR: percentage of participants with complete response (CR) or CR with incomplete marrow recovery (CRi), or partial response (PR), as determined by the investigator based on International Workshop on Chronic Lymphocytic Leukemia (IWCLL) tumor response criteria. CR: Peripheral blood lymphocytes 4,000/mcL, no significant lymphadenopathy, no hepatomegaly and splenomegaly, no disease symptoms, blood counts: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L and bone marrow normocellular for age. Cri: CR with persistent cytopenia. PR: >/= 50% decrease in peripheral blood lymphocyte count AND >/= 50% reduction in lymphadenopathy OR >/= 50% reduction of liver enlargement OR >/= 50% reduction of spleen PLUS one of the following: neutrophils >1,500/mcL, platelets > 100,000/mcL, hemoglobin > 110 g/L OR >/= 50% increase in neutrophils, platelets or hemoglobin.|3 months after the last dose of study treatment (up to approximately 5 years)|The ITT population was defined as all participants enrolled in the study regardless of whether or not they received any study drug.|||percentage of participants||95% Confidence Interval|Number
2626056|NCT01905540|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After One Dose|AUCinf is the area under the curve extrapolated to infinity, calculated using the observed value of the last nonzero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*h/mL||Standard Deviation|Mean
2626030|NCT01905943|Primary|Number of Participants With Adverse Events of Particular Interest (AEPIs)|"The following AEs were defined as AEPIs: AEs with the preferred term Progressive multifocal leukoencephalopathy (PML), hepatitis B reactivation defined as AEs with preferred term containing Hepatitis B or hepatitis acute, thrombocytopenia defined via Roche MedDRA basket subgroup haematopoietic thrombocytopenia, second malignancies defined as AEs from the SOC Neoplasms benign, malignant and unspecified starting 6 months after the first study drug intake, second malignancies based on standardised MedDRA queries (SMQ) starting 6 months after the first study drug intake based on the MedDRA SMQ Malignant or unspecified tumours, in which benign neoplasms are not included, Cardiac events including AEs from the SOC Cardiac disorders, and hemorrhagic events defined via Roche MedDRA basket subgroup Haemorrhagic events. Reported are number of participants with total AEPIs and each of the AEPI categories."|Baseline up to time of primary completion (3 years)|The safety population was defined as all participants who have received at least one dose of study medication.|||Participants|||Count of Participants
2626031|NCT01905943|Primary|Number of Participants With Adverse Events of Special Interest (AESIs)|"The following AEs were defined as AESIs: AEs with the preferred term Tumour Lysis Syndrome (TLS), Infusion-Related Reactions (IRRs) defined as AEs that occurred during or within 24 hours of the completion of obinutuzumab infusion and were assessed as related to obinutuzumab by the Investigator, Infections defined as AEs from System Organ Class (SOC) Infections and infestations and AEs with the preferred term Neutropenia. Reported are number of participants with total AESIs, IRRs, Infections, Neutropenia and TLS."|Baseline up to time of primary completion (3 years)|The safety population was defined as all participants who have received at least one dose of study medication.|||Participants|||Count of Participants
2626032|NCT01905943|Primary|Number of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs, including AEs of Special Interest and AEs of Particular Interest, were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).|Baseline up to time of primary completion (3 years)|The safety population was defined as all participants who have received at least one dose of study medication.|||Participants|||Count of Participants
2626033|NCT01905683|Secondary|Changes in Gross Motor Function Measure (GMFM)-66 Score From Baseline to All Injection Visits and End of Study|The GMFM-66 is a standardized observational 66-item instrument designed and validated to measure change in gross motor function over time in participants with cerebral palsy. Score values represent the total GMFM-66 score. Total GMFM scores range from 0 (worst) to 100 (best).|Baseline to Day 1 of 2nd (V5), 3rd (V7), 4th (V9) IC and End of study (Week 44-68) (V11)|The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available. Therefore all participants from lead-in study were included in FAS.|||units on a scale||Standard Deviation|Mean
2626034|NCT01905683|Secondary|Change in Scores of Pain Intensity (From Participants) and Frequency (From Parent/Caregiver) From Baseline to All Visits, From Day 1 of Each IC to Day 29 (Week 4), Day 57 (Week 8, 1st IC Cycle Only) and Day 99 (Week 14) of Respective Injection|The questionnaire on pain caused by Spasticity (QPS) is a participant-reported outcome for children and adolescents (2-17 years) with cerebral palsy on spasticity-related pain. Pain intensity (from participants) and pain frequency (from parent/caregiver) to be assessed with QPS. The QPS total score for pain intensity ranges from 0 ('No Hurt') to 10 ('Hurt Worst'). The QPS total score for the observed pain frequency ranges from 0 (Never) to 4 (Always). V3 = Week 4 of 1st IC; V4 = Week 8 of 1st IC; V5= Day 1 of 2nd IC; V6 = Week 4 of 2nd IC; V7 = Day 1 of 3rd IC; V8 = Week 4 of 3rd IC; V9 = Day 1 of 4th IC; V10 = Week 4 of 4th IC; V11 = Week 14 of 4th IC = end of study visit.|Baseline (Day 1, Visit [V] 2) to all other visits (V3, V4, V5, V6, V7, V8, V9, V10, and V11); From Day 1 of Each IC to Day 29 (Week 4), Day 57 (Week 8, 1st IC cycle only) and Day 99 (Week 14) of the respective IC|The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available.|||units on a scale||Standard Deviation|Mean
2626035|NCT01905683|Secondary|Changes in Modified Tardieu Scale (MTS) of Left and Right PF From Baseline to All Other Visits, From Day 1 of Each Injection Cycle (IC) to Day 29 (Week 4), Day 57 (Week 8, 1st IC Only) and Day 99 (Week 14) of the Respective Injection Cycle|"The MTS assesses spastic muscle tone by subtraction of two angles measured at different conditions of passive muscle stretch. R2 is the angle of passive range of motion with a passive movement at slow speed. R1 is the angle where a catch-and-release or clonus can be triggered at the fastest possible speed. Score values represent the measured (R2-R1) difference, that is, the dynamic tone component of the examined muscle(s). Decreases of (R2-R1) represent reductions in the dynamic component of spasticity, that is, improvement of dynamic muscle spasticity. V3 = Week 4 of 1st IC; V4 = Week 8 of 1st IC; V5 = Day 1 of 2nd IC; V6 = Week 4 of 2nd IC; V7 = Day 1 of 3rd IC; V8 = Week 4 of 3rd IC; V9 = Day 1 of 4th IC; V10 = Week 4 of 4th IC; V11 = Week 14 of 4th IC = end of study visit."|Baseline (Day 1, Visit [V] 2) to all other visits (V3, V4, V5, V6, V7, V8, V9, V10, and V11); From Day 1 of Each IC to Day 29 (Week 4), Day 57 (Week 8, 1st IC cycle only) and Day 99 (Week 14) of the respective IC|The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available.|||Degrees||Standard Deviation|Mean
2626057|NCT01905540|Primary|Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After One Dose|AUC 0-last is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*h/mL||Standard Deviation|Mean
2626036|NCT01905683|Secondary|Investigator's Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) of Left and Right PF at Day 29 (Week 4) of Each Injection Cycle|"The GICS are global outcomes to assess the impression of change due to treatment. GICS were assessed by the investigator, by the participant (if feasible) and by parents'/caregiver (if applicable). GICS is a 7-Point Likert Scale ranging from +3 (very much improved function) to -3 (very much worse function). For participants with bilateral pes equinus, the body side for efficacy analysis that is primary body side was decided by investigator at screening and was kept throughout the entire study."|Day 29 (Week 4) of 1st, 2nd, 3rd and 4th injection cycle|The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available.|||units on a scale||Standard Deviation|Mean
2626037|NCT01905683|Secondary|Investigator's, Child's/Adolescent's, and Parent's/Caregiver's Global Impression of Change Scale (GICS) at Day 29 (Week 4) of Each Injection Cycle|The GICS are global outcomes to assess the impression of change due to treatment. GICS were assessed by the investigator, by the participant (if feasible) and by parents'/caregiver (if applicable). GICS is 7-Point Likert Scale ranging from +3 (very much improved function) to -3 (very much worse function).|Day 29 (Week 4) of 1st, 2nd, 3rd and 4th injection cycle|The FAS was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available.|||units on a scale||Standard Deviation|Mean
2626038|NCT01905683|Secondary|Changes in AS Score of Left and Right Plantar Flexors (PF) From Baseline to All Other Visits, From Day 1 of Each Injection Cycle to Day 29 (Week 4), Day 57 (Week 8, 1st Injection Cycle Only) and Day 99 (Week 14) of the Respective Injection Cycle|"The Ashworth Scale (AS) is a well-known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (= no increase in tone) to 4 (=limb rigid in flexion or extension). For participants with bilateral pes equinus, the body side for efficacy analysis that is, primary body side was decided by investigator at screening and was kept throughout the entire study. V3 = Week 4 of 1st Injection Cycle; V4 = Week 8 of 1st Injection Cycle; V5 = Day 1 of 2nd Injection Cycle; V6= Week 4 of 2nd Injection Cycle; V7 = Day 1 of 3rd Injection Cycle; V8 = Week 4 of 3rd Injection Cycle; V9 = Day 1 of 4th Injection Cycle; V10 = Week 4 of 4th Injection Cycle; V11= Week 14th of 4th Injection Cycle = end of study visit."|Baseline (Day 1, Visit [V] 2) to all other visits (V3, V4, V5, V6, V7, V8, V9, V10, and V11); From Day 1 of Each Injection Cycle to Day 29 (Week 4), Day 57 (Week 8, 1st Injection Cycle only) and Day 99 (Week 14) of the respective Injection Cycle|The full analysis set (FAS) was the subset of participants in the SES for whom at least a baseline value (Day 1 of the first cycle, Visit 2) of AS score of PF was available. For participants from lead-in study at least one post-baseline value was available.|||units on a scale||Standard Deviation|Mean
2626039|NCT01905683|Secondary|Investigator's Global Assessment of Tolerability at Day 99 (Week 14) of Each Injection Cycle|The investigator's global assessment of tolerability was assessed on a 4-point ordinal scale where 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Results for Day 99 (Week 14) of 4th injection cycles were collected at the end of study visit.|Day 99 (Week 14) of 1st, 2nd, 3rd and 4th injection cycle|The SES was the subset of all participants treated with IP at least once.|||participants|||Number
2626040|NCT01905683|Primary|Occurrence of Treatment-emergent Serious Adverse Events (TESAEs) Overall and Per Injection Cycle|TESAEs are events observed from the time point of first injection until end of study visit (Week 50-66). Values reported here refer to the number of participants affected.|From the timepoint of first injection until end of study visit (Week 50-66)|The SES was the subset of all participants treated with IP at least once.|||participants|||Number
2626041|NCT01905683|Primary|Occurrence of Treatment Emergent Adverse Events of Special Interest (TEAESI) Overall and Per Injection Cycle|TEAEs occurring after treatment that were thought to possibly indicate toxin spread throughout the trial conduct are defined as TEAESI. Values reported here refer to the number of participants affected.|From the timepoint of first injection until end of study visit (Week 50-66)|The SES was the subset of all participants treated with IP at least once.|||participants|||Number
2626042|NCT01905683|Primary|Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle|TEAEs are events observed from the time point of first injection until end of study visit (Week 50-66). Values reported here refer to the number of participants affected.|From the timepoint of first injection up to end of study visit (Week 50-66)|The SES was the subset of all participants treated with IP at least once.|||participants|||Number
2626043|NCT01905657|Secondary|Duration of Response (DOR) by RECIST 1.1|DOR is measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). DOR was censored at the last tumor assessment date if a responder did not have PD or death. Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method and is reported in weeks.|Through database cutoff date of 30 Sep 2015 (Approximately 23 months)|The ITT population consisted of all participants who were randomized. Participants were included in the treatment group to which they were randomized.|||Weeks||Full Range|Median
2626044|NCT01905657|Secondary|Overall Response Rate (ORR) by RECIST 1.1|ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) based on blinded independent central radiologists' review using RECIST 1.1.|Through database cutoff date of 30 Sep 2015 (Approximately 23 months)|The ITT population consisted of all participants who were randomized and included in the efficacy analysis. Participants were included in the treatment group to which they were randomized.|||Percentage of Participants||95% Confidence Interval|Number
2626090|NCT01904604|Primary|Percentage of Subjects With a Successful Treatment Response|Treatment response is defined as a subject who can either (a) successfully consume a cumulative dose of peanut protein equal to or greater than 5044 mg or (b) successfully consume at least a 10-fold increase in peanut protein at the Week 52 oral food challenge (OFC), when compared to the cumulative successfully consumed dose at the baseline OFC.|Week 52|All randomized subjects who received study treatment.|||percentage of participants|||Number
2626045|NCT01905657|Primary|Percentage of Participants Discontinuing Study Drug Due to AEs|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE.|Up to approximately 23 months|The APAT population consisted of all participants who received at least one dose of study drug. Participants were included in the treatment group based on the study treatment they received.|||Percentage of Participants|||Number
2626046|NCT01905657|Primary|Percentage of Participants Experiencing Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. After discontinuation of study drug, each participant was monitored for a minimum of 30 days after last dose of study drug (serious AEs were monitored for up to 90 days after last dose of study drug).|AEs: Up to 30 days after last dose of study drug (Up to approximately 24 months). Serious AEs: Up to 90 days after last dose of study drug (Up to approximately 27 months).|The All Participants As Treated (APAT) population consisted of all participants who received at least one dose of study drug. Participants were included in the treatment group based on the study treatment they received.|||Percentage of Participants|||Number
2626047|NCT01905657|Primary|Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)|PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists' review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of >5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months.|Through database cutoff date of 30 Sep 2015 (Approximately 23 months)|The ITT population consisted of all participants who were randomized and included in the efficacy analysis. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2626048|NCT01905657|Primary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. OS was analyzed using the Kaplan-Meier method and is reported in months.|Through database cutoff date of 30 Sep 2015 (Approximately 23 months)|The Intent-To-Treat population consisted of all participants who were randomized and were included in the efficacy analysis. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2626049|NCT01905553|Primary|Maximum Plasma Concentration (Cmax) of SSP-004184 Under Fed and Fasted Conditions|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 96 hours post-dose||||ng/mL||Standard Deviation|Mean
2626050|NCT01905553|Primary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of SSP-004184 Under Fed and Fasted Conditions|AUClast is the area under the curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 96 hours post-dose|Pharmacokinetic Set: All subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*hr/mL||Standard Deviation|Mean
2626051|NCT01905553|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 Under Fasted and Fed Conditions|AUCinf is the area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 96 Hours post-dose|Pharmacokinetic Set: All subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*hr/mL||Standard Deviation|Mean
2626052|NCT01905540|Secondary|Maximum Plasma Concentration (Cmax) of SSP-004184 After Two Doses|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng/mL||Standard Deviation|Mean
2626053|NCT01905540|Secondary|Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After Two Doses|AUCinf is the area under the plasma concentration versus time curve extrapolated to infinity, calculated using the observed value of the last nonzero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product, had at least 1 post-dose safety assessment, and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*hr/mL||Standard Deviation|Mean
2626054|NCT01905540|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After Two Doses|AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 120 hours post-dose|Pharmacokinetic Set: All subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment and for whom the primary pharmacokinetic data were considered sufficient and interpretable.|||ng*hr/mL||Standard Deviation|Mean
2626058|NCT01905423|Secondary|Filarial Antigenemia in Blood and Worm Parasite Eggs in Stool by Microscopy|Secondary outcomes for the study include prevalence of filarial antigenemia (detected with the Binax Filariasis Now card test) and prevalence of worm eggs in stool detected by the Kato-Katz test. Both of these prevalence outcomes are qualitative with no units of measure (positive or negative). Prevalence date are expressed as % positive. Other secondary outcome measures will be intensity of parasite infections (microfilariae per ml of blood and the number of worm eggs per gram of stool).|4 years|Not all participants were tested for antigen or provided stool to determine prevalence of worm eggs.|||Participants|||Count of Participants
2626059|NCT01905423|Primary|Microfilaria Prevalence in Blood by Microscopy|Microfilariae (filarial parasites) will be detected in blood smears by microscopy. Samples will be collected in annual community surveys. Microfilaremia is a categorical variable (positive or negative). Prevalence rates are expressed as % positive.|4 years|Analysis excludes participants from Pekalongan study site that were dropped after the first follow-up due to lower than expected filariasis prevalence.|||Participants|||Count of Participants
2626060|NCT01905267|Secondary|Change in Reynolds Adolescent Depression Scale|Self report adolescent depression total score. Range is 30-120 with higher scores meaning greater depressive symptoms.|Baseline, 8 week|8 week completers sample|||units on a scale||Standard Deviation|Mean
2626061|NCT01905267|Primary|Change in Children's Depression Rating Scale - Revised|clinician measure completed with adolescent and parent Total scores reported. Range is between 17-119 Higher scores mean higher depressive symptoms|Baseline, 8 week|completers sample|||units on a scale||Standard Deviation|Mean
2626062|NCT01905254|Primary|Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis|The aim of the current study was to assess the diagnostic accuracy (Sens., Spec.) of transient elastography for the determination of cirrhosis in patients with autoimmune hepatitis. TE was compared to the diagnosis of cirrhosis made on histology yielded by laparoscopic guided liver biopsy.|Transient Elastography compared to liver histology|Sensitivity, specifity; Positive and negative predictive value of TE for diagnosis of cirrhosis was analyzed.|||Probability|||Number
2626063|NCT01904864|Primary|Hemoglobin Concentration Over Time|The primary outcome will be the change in the peripheral blood hemoglobin concentration in grams/deciliter upon serial measurements at 0, 4, 8, and 12 weeks post-initiation of treatment. The primary analysis consists of a linear mixed regression model, which incorporates all subsequent time points into the model and includes treatment and time as covariates and patient random effects to account for correlation among longitudinal measurements from the same patients.|12 weeks||||g/dL||Standard Deviation|Mean
2626064|NCT01904773|Primary|Pharmacokinetics : AUC (h*ng/ ml) - Part 1 Only|Pharmacokinetics Part 1 only: Single dose Day 1 AZD5213 0.5 mg Area Under the Concentration time curve (AUC) 0 to infinity (h*ng/ml)|Day 1|Pharmacokinetic population|||AUC (h*ng/ml)||Standard Deviation|Mean
2626065|NCT01904773|Primary|Pharmacokinetics : Time to Maximum Concentration (hr) - Part 1 Only|Pharmacokinetics Part 1 only: Time to maximum plasma concentration (hr)Single dose Day 1 AZD5213 0.5 mg|Day 1|Pharmacokinetic population|||Time (hr)||Standard Deviation|Mean
2626066|NCT01904773|Primary|Pharmacokinetics : Maximum Plasma Concentration (ng/ml) - Part 1 Only|Pharmacokinetics Part 1 only: Maximum plasma Concentration (ng/ml) Single dose Day 1 AZD5213 0.5 mg|Day 1|Pharmacokinetic population|||Plasma concentration (ng/ml)||Standard Deviation|Mean
2626067|NCT01904773|Primary|Total Tic Severity Score (Part 2 Only) Crossover Analysis Over 6 Periods|Total Tic Severity Score on the the Yale Global Tic Severity Scale - Part 2 only (lower is better), range 0 - 50|3 week period of treatment|All Part 2 participants|||Total Tic Severity Score||Standard Error|Least Squares Mean
2626068|NCT01904760|Other Pre-specified|Pain Score Within 5 Days Postoperatively|Participants are followed for 5 days after operation and their pain score are evaluated by VAS method every afternoon on each of the 5 days. Patients' pain score on maxillofacial region and flap donation region are evaluated respectively.|on each of the 5 days postoperatively|||||||
2626069|NCT01904760|Other Pre-specified|Sleep Quality Within 5 Days Postoperatively|Participants are followed for 5 days after operation and their sleep quality are evaluated every afternoon on each of the 5 days.|on each of the 5 days postoperatively|||||||
2626070|NCT01904760|Other Pre-specified|Overall Feeling in PACU|Patients' overall feeling in PACU are evaluated by a numerous scale(0-10) at 8am the next day.|at 8am the next day|||||||
2626071|NCT01904760|Other Pre-specified|Sleep Quality in PACU|Patients' sleep quality in PACU are evaluated by a numerous scale(0-10) at 8am the next day.|at 8am the next day|||||||
2626072|NCT01904760|Other Pre-specified|Pain Score in PACU|Patients' pain score are evaluated by a numerous scale(0-10) at 8am the next day, just before they leave PACU.|at 8 am the next day|||||||
2626073|NCT01904760|Other Pre-specified|Use of Analgesics and Sedatives in PACU|extra analgesics and sedatives will be given when patients are agitated or if the patients ask for them.|participants will be followed for the duration of PACU stay, an expected average of 12 hours|||||||
2626074|NCT01904760|Other Pre-specified|Patients' Vital Signs in PACU|Patient's vital signs including heart rate, blood pressure, pulse oxygen saturation and respiratory rate are monitored continuously in PACU and recorded on 1,2,4,6,12 hour after PACU admission.|participants will be followed for the duration of PACU stay, an expected average of 12 hours|||||||
2626075|NCT01904760|Secondary|Postoperative Delirium|Patients are sent back to wards the next morning after operation and followed up on each of the 5 days postoperatively. Delirium will be confirmed based on CAM-ICU method.|on each of the 5 days postoperatively||||participants|||Number
2626076|NCT01904760|Primary|Agitation in PACU|Patients are kept calm and cooperative in the PACU. Agitation is defined as Riker-Agitation Scale(SAS)>=5.|participants will be followed for the duration of PACU stay, an expected average of 12 hours||||participants|||Number
2626077|NCT01904721|Secondary|Change From Baseline in Target Area Hair Darkness (TAHD)|Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the darkness of terminal hairs).|Baseline, Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements|||Intensity Units||Standard Deviation|Mean
2626078|NCT01904721|Secondary|Change From Baseline in Target Area Hair Width (TAHW)|Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs).|Baseline, Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements|||mm/cm2||Standard Deviation|Mean
2626079|NCT01904721|Secondary|Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score|"At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: Compared with the baseline image, the amount of the subject's hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements|||Percentage of Participants|||Number
2626080|NCT01904721|Secondary|Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score|"The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: Since the start of the study, the amount of the subject's hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements|||Percentage of Participants|||Number
2626081|NCT01904721|Primary|Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score|"The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: Since the start of the study, the amount of my hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented."|Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements|||Percentage of Participants|||Number
2626082|NCT01904721|Primary|Change From Baseline in Target Area Hair Count (TAHC)|TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs).|Baseline, Month 6|Modified Intent-to-Treat: all randomized patients in Stage 2 who received study medication and who had both baseline and follow-up TAHC measurements|||terminal hairs/cm2||Standard Deviation|Mean
2626083|NCT01904604|Secondary|Percentage of Subjects Who Successfully Complete the Dosing Regimen With no More Than Mild Symptoms Related to Peanut Patch Dosing After 30 Months of Therapy|Mild symptoms related to peanut patch dosing are defined as patch site reactions up to Grade 2 in severity or mild systemic dosing symptoms.|Month 30 (Week 130)|All randomized subjects who received active (not placebo) study treatment. The Placebo Patch group includes the 20 subjects who crossed over to active treatment.|||percentage of participants|||Number
2626084|NCT01904604|Secondary|Percentage of Subjects With Adverse Events Related to Therapy Through Week 52 and Through 30 Months|Adverse events (AEs) related to study therapy includes both unsolicited AEs where there was a reasonable possibility that the study product caused the event as well as solicited AEs related to dosing.|Week 52 and Month 30 (Week 130)|All randomized subjects who received study treatment were included in the analysis. For the Placebo Patch group, at Week 130 only the 20 participants who crossed over to active treatment were included.|||percentage of participants|||Number
2626085|NCT01904604|Secondary|Percentage of Subjects Who Pass an OFC to 5044 mg of Peanut Protein Followed by an Open Feeding of Peanut Butter After 8 Weeks or 20 Weeks of Discontinuation of Dosing Subsequent to Passing the Week 130 Oral Food Challenge (OFC)|Subjects who after passing the Week 130 (Month 30) discontinue dosing for 8 weeks and later 20 weeks successfully consumed 5044 mg peanut protein during an OFC followed by an open feeding of peanut butter.|8 and 20 weeks after the Week 130 (Month 30) OFC|None of the participants passed the Week 130 OFC so this could not be assessed.||||||
2626086|NCT01904604|Secondary|Average Successfully Consumed Dose as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)|The successfully consumed dose (SCD) is the cumulative dose consumed during an oral food challenge without dose-limiting symptoms that led to the termination of the challenge.|Week 52|All randomized subjects who completed the Week 52 OFC.|||mg protein||Full Range|Median
2626087|NCT01904604|Secondary|Percentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)|"Desensitization is defined based on successfully consumed dose in mg protein at the Week 52 oral food challenge (OFC) as follows:~0-44 mg at BL, >=444 mg at Wk52 2) >44-<444 mg at BL, 10-fold increase at Wk 52 3) >=444 mg at BL, >=5,044 mg at Wk 52.~BL=Baseline, Wk 52=Week 52"|Week 52|All randomized subjects who received active (not placebo) study treatment.|||percentage of participants|||Number
2626088|NCT01904604|Secondary|Percentage of Subjects Who Can Successfully Consume 1044 mg or 5044 mg Peanut Protein|Subjects who successfully consumed without dose-limiting symptoms 1044 mg or 5044 mg peanut protein during the Week 130 oral food challenge (OFC). This is referred to as the successfully consumed dose (SCD). The maximum SCD for this OFC was 5044 mg peanut protein.|Week 130 (Month 30)|All randomized subjects who received active (not placebo) study treatment. For the Placebo Patch group, this only includes the 20 subjects who crossed over to active treatment.|||percentage of participants||95% Confidence Interval|Number
2626089|NCT01904604|Secondary|Percentage of Subjects Desensitized to Peanut Protein|"Desensitization is defined based on successfully consumed dose in mg protein at the Week 130 oral food challenge (OFC) as follows:~1) 0-44 mg at BL, >=444 mg at Wk 130 2) >44-<444 mg at BL, 10-fold increase at Wk 130 3) >=444 mg at BL, >=5,044 mg at Wk 130.~BL=Baseline, Wk 130=Week 130 (Month 30)"|Week 130 (Month 30)|All randomized subjects who received active (not placebo) study treatment. For the Placebo Patch group, this only includes the 20 subjects who crossed over to active treatment.|||percentage of participants||95% Confidence Interval|Number
2626092|NCT01904526|Secondary|Heart Rate|Evaluate the safety and tolerability of guanfacine by measuring physiologic reactivity (e.g., heart rate)|Last day of titration period 1 (Day 21) to the last day of titration period 3 (Day 57)|Last day of titration period: 3 mg/day IR (Day 21) followed by 4mg/day ER (Day 48) followed by 6mg/day ER (Day 57)|||beats per minute||Standard Error|Mean
2626093|NCT01904526|Primary|Plasma Trough Levels of Guanfacine|Evaluate whether a 4mg/day or 6mg/day dose of extended-release guanfacine produces pharmacokinetic (PK) properties similar to 3mg/day immediate release guanfacine by measuring plasma trough levels of guanfacine for each dose|+24 hours on Lab Session days (Days 22, 49, 58)|3 mg/day IR (Day 22) followed by 4mg/day ER (Day 49) followed by 6mg/day ER (Day 58)|||ng/ml||Standard Error|Mean
2626094|NCT01904448|Secondary|Pre-School Language Scale (PLS-5) Scores|The PLS-5 is a standardized language test designed for infants and young children. The Auditory Comprehension subscale targets skills known to precede language development, including: attention to speakers, appropriate object play, basic vocabulary, concepts, grammatical markers, and complex sentences. The Expressive Communication subscale assesses vocal development, social communication, naming of common objects, phonological awareness, sequencing skills, as well as use of concepts, prepositions, grammatical markers, and varying sentence structures.|Year 1, Year 2, Year 3|Since spoken language skills did not progress as expected, this measure was inappropriate for use in the study and was unobtainable.||||||
2626095|NCT01904448|Secondary|Change in Speech Perception Test Battery Scores-ESP Standard|A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until they demonstrated a minimum performance on the previous measure. This may have been due to child's age or inability to complete task. The Early Speech Perception (ESP) Standard measures the progression of speech discrimination skills in children (age 5+) with profound hearing loss as they develop. The stimuli consist of 3 subtests [1) patterns and words, 2) monosyllable, 3) spondees] of 12 pictured words each presented in an auditory-only condition. The format is a closed-set. Two repetitions of each item are given for a total of 24 items for each subtest. Each subtest is scored by the percent of correctly identified items from the set of pictured words.|Year 1, Year 2, Year 3|Missing values indicate test was not administered at that interval and ESP-LV (Low Verbal) was administered.|||percentage of correct answers|||Number
2626096|NCT01904448|Secondary|Change in Speech Perception Test Battery Scores-ESP Low Verbal|"A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until they demonstrated a minimum performance on the previous measure.~The Early Speech Perception (ESP) low verbal version estimates speech perception abilities in very young children who have limited verbal abilities. Stimuli consist of words varying in pattern as well as spondees and monosyllabic words presented in sets of four. The format is four item closed-set. Test materials consist of objects (toys) instead of pictures. It is scored by the percent of correctly identified items from the set of 4; 3 repetitions of each item are given for a total of 12 trials."|Year 1, Year 2, Year 3|Missing values indicate test was not administered at that interval and ESP-Standard was administered.|||percentage of correct answers|||Number
2626097|NCT01904448|Secondary|Change in Speech Perception Test Battery Scores-Ling Sound Test|"A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until they demonstrated a minimum performance on the previous measure.~The Ling- 6 sounds test is a speech sound detection measurement of detection thresholds performed by an audiologist. Six sound files of ah, ee, oo, sh, s, and m are presented one at a time in varying order for measurement of hearing threshold groups, per sound. The selected sounds tested validate hearing device fitting across the frequency range important for understanding speech. If the child can detect the stimuli a point is given and if they can not detect, no point is given. A total of 3 trials per sound were presented for a total of 18 presentations. The score reflects a percent of the total sounds that were detected."|Year 1, Year 2, Year 3|Single-arm study of Auditory Brainstem Implantation (ABI) in children|||percent correct|||Number
2626098|NCT01904448|Secondary|Speech Perception Test Battery Scores-IT-MAIS or MAIS|"A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until demonstrating a minimum performance on the previous measure.~The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) is a parent questionnaire consisting of ten questions regarding a young infant or toddler's auditory behavior, e.g., Does the child spontaneously respond to his/her name in quiet with auditory cues? Each question is scored on a five point scale: 0 = never, 1 = rarely, 2 = occasionally, 3 = frequently, and 4 = always. The aim of this tool is to assess the benefit of the child's personal amplification device(s) and is used to assess hearing aid benefit. Higher scores reflect more consistent auditory response. Scores reported are the percentage of correctly answered questions of the total asked."|Pre-ABI, Year 1, Year 2, Year 3||||percent correct|||Number
2626099|NCT01904448|Secondary|Change in Speech Perception Test Battery Scores-Detection Audiogram|Sound detection for octave frequencies of 250 Hz through 8k Hz were collected and a 4 frequency average was calculated for each annual test interval|Year 1, Year 2, Year 3||||averaged decibel level|||Number
2626100|NCT01904448|Secondary|Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues|Measure of percent correct on consonant voicing cue production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct voicing of consonant production on 25 items.|Year 1, Year 2, Year 3||||percentage of correct answers|||Number
2626101|NCT01904448|Secondary|Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues|Measure of percent correct on consonant place cue production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct place of consonant production on 25 items.|Year 1, Year 2, Year 3||||percentage of correct answers|||Number
2626102|NCT01904448|Secondary|Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants|Measure of percent correct on final consonant production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced a final consonant on 25 items.|Year 1, Year 2, Year 3||||percentage of correct answers|||Number
2626103|NCT01904448|Secondary|Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues|Measure of percent correct on consonant manner cues production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct manner of consonant production on 25 items.|Year 1, Year 2, Year 3||||percentage of correct answers|||Number
2626104|NCT01904448|Secondary|Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels|Measure of percent correct on vowel production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct vowel on 25 items.|Year 1, Year 2, Year 3||||percentage of correct answers|||Number
2626105|NCT01904448|Secondary|Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants|Measure of percent correct on initial consonant production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced an initial consonant on 25 items.|Year 1, Year 2, Year 3||||percentage of correct answers|||Number
2626106|NCT01904448|Secondary|Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables|Measure of percent correct for use of syllables elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct number of syllables on 25 items.|Year 1, Year 2, Year 3||||percentage of correct answers|||Number
2626107|NCT01904448|Secondary|Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand|This is a measure of the child's ability to vocalize on demand elicited by pictures of objects. Scores are derived from the percentage of time the child vocalized for 25 words.|Year 1, Year 2, Year 3||||percentage of correct answers|||Number
2626108|NCT01904448|Secondary|MacArthur-Bates Communicative Development Inventories (CDIs) Score|MacArthur-Bates Communicative Development Inventories (CDIs)|Year 3|Since spoken language skills did not progress as expected, this measure was inappropriate for use in the study and was unobtainable.||||||
2626109|NCT01904448|Secondary|Goldman-Fristoe Test of Articulation Scores (GFTA)|The GFTA-2 is a standardized, norm-based articulation measure that samples spontaneous sound production. Children are asked to respond to picture plates and verbal cues from the examiner with single words that test consonant accuracy in initial, medial, and final positions. This measure has norms based on the performance of normal-hearing children from age 2 years to 21 years.|Year 3|Due to limited progress in spoken language development and test difficulty, this measure was replaced by Identifying Early Phonological Needs in children with hearing loss (IEPN). No data were collected for this measure.||||||
2626110|NCT01904448|Secondary|The Oral and Written Language Scales (OWLS) Oral Expression Score|OWLS-II: Oral Expression measures oral language expression, which is the use of spoken language. The examiner presents a verbal prompt along with a picture and the participant must respond orally to the prompt with increasingly difficult language. The derived mean standard score for this test is 100 with a standard deviation of 15. Higher scores indicate better oral expression. Scores of 85 to 115 are within normal limits. Scores that fall 2 standard deviations below the mean are considered to be severely delayed.|Year 3||||units on a scale|||Number
2626111|NCT01904448|Secondary|The Oral and Written Language Scales (OWLS) Listening Comprehension Score|OWLS-II: Listening Comprehension measures oral language reception, which is the understanding of spoken language. The examiner orally presents increasingly difficult words, phrases, and sentences to the participant and he/she responds by pointing to or stating which of four pictures is correct. The derived mean standard score for this test is 100 with a standard deviation of 15. Higher scores indicate better listening comprehension. Scores of 85 to 115 are within normal limits. Scores that fall 2 standard deviations below the mean are considered to be severely delayed.|Year 3||||units on a scale|||Number
2626112|NCT01904448|Primary|Number of ABI Complications|Complications and related outcomes will be tracked and recorded. These include bleeding, infection, neural injury, cerebrospinal fluid (CSF) leakage, brain bleeding or bruising, stroke, death. Also, complications and sequelae related to the device such as non-auditory stimulation and device failure will be tracked.|Year 3||||Events|||Number
2626113|NCT01904383|Secondary|The Mean Change From Baseline to Last Observation of the Treatment Period in Haemoglobin A1c (HbA1c)|The mean change from baseline to last observation of the treatment period in Haemoglobin A1c (HbA1c).|Baseline (before administration of treatment) and last observation of the treatment period; up to 156 weeks.|Efficacy set: This patient set included all patients with Trazenta® Tablets in the safety set who had a baseline and at least one available on-treatment HbA1c value and had type 2 diabetes mellitus.|||Percentage (%)||Standard Deviation|Mean
2626114|NCT01904383|Primary|Percentage of Participants With Drug Related Adverse Events|Percentage of participants with drug related adverse events.|From first drug administration until last drug administration, up to approximately 156 weeks.|Safety set: This patient set included all patients who were dispensed Trazenta® Tablets as add-on therapy, and had at least 1 observation after treatment. The patients treated with Trazenta® Tablets as monotherapy were not included.|||Percentage (%) of participants|||Number
2626115|NCT01904279|Secondary|Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential||Baseline up to Week 52|Safety population.|||percentage of participants|||Number
2626116|NCT01904279|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement.|Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52|Safety population. Number Analyzed represents participants evaluable for the specified category.|||millimeters per hour (mm/h)||Standard Deviation|Mean
2626117|NCT01904279|Secondary|Change From Baseline in C-Reactive Protein (CRP) Levels||Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52|Safety population. Number Analyzed represents participants evaluable for the specified category.|||mg/L||Standard Deviation|Mean
2626118|NCT01904279|Secondary|Change From Baseline in Soluble IL-6 Receptor Levels||Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52|Safety population. Here Number of participants analyzed represents participants evaluable for this outcome measure. Number Analyzed represents participants evaluable for the specified category.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2626119|NCT01904279|Secondary|Change From Baseline in Serum Interleukin-6 (IL-6) Levels|IL-6 is a cytokine associated with disease activity in juvenile idiopathic arthritis (JIA) including the polyarticular juvenile idiopathic arthritis (pJIA) subset. It is found in high levels in the synovial fluid and is associated with indicators of inflammatory activity.|Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52|Safety population. Here Number of participants analyzed represents participants evaluable for this outcome measure. Number Analyzed represents participants evaluable for the specified category.|||picograms/milliliter (pg/mL)||Standard Deviation|Mean
2626120|NCT01904279|Primary|Maximum Serum Concentration (Cmax) of TCZ at Steady State|Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, ,2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.|Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)|Pharmacokinetic population|||mcg/mL||Full Range|Median
2626121|NCT01904279|Primary|Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment|Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016 hours post Day 1 dose (additionally at 6, 12, 48, 120 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016 post Day 1 dose.|Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)|Pharmacokinetic population.|||mcg*day/mL||Full Range|Mean
2626122|NCT01904279|Primary|Minimum Serum Concentration (Cmin) of TCZ at Steady State|Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, 2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.|Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)|Pharmacokinetic population included all enrolled participants who were adherent to the protocol.|||Micrograms/milliliter (mcg/mL)||Full Range|Median
2626123|NCT01904149|Secondary|Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale)|"Percentage of responders; response defined as achievement a mean pain intensity, PI-VAS < 40 mm (PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale, 0=no pain to 100=worst pain imaginable), over 48 hours of the multiple-dose phase.~The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL."|over 48 hours of the multiple-dose phase|ITT population|||percentage of participants|||Number
2626124|NCT01904149|Secondary|SPID48 (Sum of Pain Intensity Differences Over 48 Hours of the Multiple-dose Phase)|"Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 48 hours of the multiple-dose phase.~PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured every two hours over the first 48 hours of the multiple-dose phase. A higher value in SPID indicates greater pain relief.~The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL."|over 48 hours of the multiple-dose phase|ITT population|||units on a scale||Standard Deviation|Mean
2626125|NCT01904149|Secondary|Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)|"Percentage of responders over 8 hours after first dose, according to the 50% maximum total pain relief rule: maximum TOTPAR calculated as the theoretical maximum weighted sum of PAR-VRS (Pain Relief - Verbal Rating Scale: pain relief 0=none, 4=complete) scores.~The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo."|over 8 hours after first dose|ITT population|||percentage of participants|||Number
2626126|NCT01904149|Primary|SPID8 (Sum of Pain Intensity Differences Over 8 Hours)|"Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief.~The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo."|over 8 hours after the first dose|ITT population|||units on a scale||Standard Deviation|Mean
2626127|NCT01904071|Other Pre-specified|Pain Score at 480 Minutes|Pain score at 480 minutes post administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|480 minutes|Pain scores were not obtained for 4 patients in the UFNB group, 3 patients in the UFIB group, and 3 patients in the IVMS group at 480 minutes|||units on a scale||Standard Deviation|Mean
2626128|NCT01904071|Other Pre-specified|Pain Score at 240 Minutes|Pain Score at 240 minutes post administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|240 minutes|Pain score was not obtained for one patient in the UFNB group at 240 minutes|||units on a scale||Standard Deviation|Mean
2626129|NCT01904071|Other Pre-specified|Pain Score at 120 Minutes|Pain score at 120 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|120 minutes|Pain score was not obtained for one patient in the IVMS group at 120 minutes.|||units on a scale||Standard Deviation|Mean
2626130|NCT01904071|Secondary|Pain Score at 60 Minutes|Pain score at 60 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|60 minutes||||units on a scale||Standard Deviation|Mean
2626131|NCT01904071|Primary|Pain Score at 30 Minutes|Pain Score at 30 minutes post-administration of pain control treatment. Pain Scale: Scores range from 0 (no pain) to 10 (sever pain). A score of 5 is moderate pain|30 minutes||||units on a scale||Standard Deviation|Mean
2626152|NCT01903863|Secondary|Red Blood Cell Transfusion|Compared red blood cell transfusion during ECMO for control versus treatment group|ECMO course (median 198 hours)||||ml/kilogram/ECMO day||Inter-Quartile Range|Median
2626132|NCT01904058|Other Pre-specified|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the product. A serious adverse event (SAE) was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly or birth defect; an important medical event that did not meet any of the above criteria but jeopardized the participant or required medical or surgical intervention to prevent one of the outcomes listed above. A TEAE was defined as any AE that occurred during the study, from the start of investigational product dosing through the end of the study (13 weeks of treatment period (or ET) + 14 days ]), or that worsened since the start of dosing.|From the first dose of study drug until the 13 weeks of treatment period (or ET) + 14 days (approximately 15 weeks)|The Safety Population included all participants who were randomized and received at least 1 dose of the study drug. One participant was randomized to LUM001 10 mg, but was down-titrated to 5 mg dose due to tolerability issues. The safety data has been summarized based on the study dose actually received by the participant.|||participants|||Number
2626133|NCT01904058|Secondary|Change From Baseline in Bile Acid Synthesis as Measured by Serum 7 Alpha-Hydroxy-4-Cholesten-3-One C4 Level [7 Alpha C4]) at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)|C4 7 alpha-hydroxy-4-cholesten-3-one is an intermediate in the biochemical synthesis of bile acids from cholesterol and its concentrations reflect the activity of the bile acid synthetic pathway. Elevated levels of C4 indicate bile acid malabsorption. Laboratory C4 levels were evaluated using blood samples collected.|Baseline, Weeks 4, 8, 13 and Last Post-baseline Visit (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2626134|NCT01904058|Secondary|Change From Baseline in Fasting Serum Bile Acid Level at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)|Laboratory serum bile acid level levels were evaluated using blood samples collected.|Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.|||micromoles per liter||Standard Deviation|Mean
2626135|NCT01904058|Secondary|Change From Baseline in 5-D Itch Score at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)|The 5-D itch (validated instrument to measure pruritus) scale was developed for the multidimensional quantification of pruritus that is sensitive to change over time. The 5-D itch scale included 5 domains (duration, degree, direction, disability, and distribution of pruritus). The total 5-D score was obtained by scoring each of the domains separately and then summing them together. 5-D total scores ranged between 5 (no pruritus) and 25 (most severe pruritus).|Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.|||units on a scale||Standard Deviation|Mean
2626136|NCT01904058|Secondary|Change From Baseline in Alkaline Phosphatase (ALP) at Weeks 4, 8, 13, and Last Post-baseline Visit (Week 13/ET)|Laboratory serum ALP enzyme levels were evaluated using blood samples collected.|Baseline, Weeks 4, 8, 13 and Last Post-baseline (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.|||units per liter (U/L)||Standard Deviation|Mean
2626137|NCT01904058|Secondary|Change From Baseline in Pruritus Using Adult ItchRO Average Daily Scores at Weeks 4, 8, 13, and Last Post-baseline Visit (Week 13/ET)|ItchRO scores had a range from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. Adult ItchRO average daily score was the sum of daily scores divided by the number of days adult ItchRO was completed, using the 7 days prior to the reported visit date.|Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.|||units on a scale||Standard Deviation|Mean
2626138|NCT01904058|Secondary|Change From Baseline in Pruritus Using Adult ItchRO Weekly Sum Scores at Weeks 4, 8 and 13|ItchRO scores had a range from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. The weekly sum score was calculated as the sum of the daily scores for the 7 days prior to the time point being reported: 7 days prior to randomization or 7 days prior to Week 13/ET visit.|Baseline, Weeks 4, 8 and 13|mITT Population. Here, “n” signifies the number of participants evaluable for the respective time points.|||units on a scale||Standard Deviation|Mean
2626139|NCT01904058|Primary|Change From Baseline in Pruritus Using Adult Itch Reported Outcome (ItchRO) Weekly Sum Score at Week 13/ Early Termination (ET)|Pruritus was assessed using ItchRO measure, administered as an electronic diary (eDiary) which was completed by the participants twice daily (morning and evening). (ItchRO) scores ranged from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. The weekly sum score was calculated as the sum of the daily scores for the 7 days prior to the time point being reported: 7 days prior to randomization or 7 days prior to Week 13/ET visit.|Baseline and Week 13/ET|The mITT population included all participants who were randomized, received at least 1 dose of treatment, and had at least 1 post-baseline ItchRO assessment.|||units on a scale||Standard Deviation|Mean
2626140|NCT01903993|Secondary|DOR (Modified RECIST)|DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.|From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. Here, number of participants analyzed signifies the number of participants who were evaluable for this outcome measure. The data was planned to be reported for Atezolizumab arm only.|||months||95% Confidence Interval|Median
2626153|NCT01903863|Secondary|Plasma Free Hemoglobin|Compare plasma free hemoglobin levels between control and treatment group|ECMO course (median 198 hours)||||mg/dL||Inter-Quartile Range|Median
2626141|NCT01903993|Secondary|PFS (Modified RECIST)|PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using modified RECIST criteria. PD: at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned. The data was planned to be reported for Atezolizumab arm only|||months||95% Confidence Interval|Median
2626142|NCT01903993|Secondary|ORR (Modified RECIST)|ORR was defined as the percentage of participants with confirmed objective tumor response, CR or PR, as determined by investigator using modified RECIST criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to l< 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned. The data was planned to be reported for Atezolizumab arm only|||percentage of participants||95% Confidence Interval|Number
2626143|NCT01903993|Secondary|Duration of Response (DOR)|DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.|From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. Here, number of participants analyzed signifies the number of participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2626144|NCT01903993|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression was determined based on investigator assessment using response evaluation criteria In solid tumors (RECIST) v1.1. Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions including baseline In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.|||months||95% Confidence Interval|Median
2626145|NCT01903993|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with confirmed objective tumor response, complete response (CR) or partial response (PR), as determined by investigator using RECIST v1.1 criteria. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|Baseline until date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.|||percentage of participants||95% Confidence Interval|Number
2626146|NCT01903993|Primary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.|From the time of randomization to the date of death due to any cause or up to data cut off date: 01 Dec 2015 (up to 28 months)|ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. In the efficacy analyses, the ITT population, participants were grouped according to the treatment arm to which they were assigned.|||months||95% Confidence Interval|Median
2626147|NCT01903876|Secondary|Sexual Violence Perpetration|This scale is the Conflict Tactics Scale revised, Sexual Coercion Subscale and assessed the number of sexually coercive/violent behaviors engaged in during the past 6 months. The index ranges from 0 (no engagement in any sexual violence) to 7 (engaged in all 7 sexually violent behaviors).|6 months|For some of the variables in this analysis, there were missing data. ANCOVA performed in SPSS will use a listwise deletion. This resulted in n=87 and n=115 for this analysis.|||score on a scale||Standard Error|Mean
2626148|NCT01903876|Primary|Prosocial Intervening Behavior|This scale is the Reactions to Offensive Language and Behavior (ROLB) index that measures whether or not men confronted inappropriate behaviors of other men. We used the 7-item self-behavior subscale plus an additional 8 items, which directly reflected the content of RealConsent. A series of 15 potential intervening situations were presented and participants were asked to indicate whether they had experienced this situation in past 6 months (yes/no), and whether they had intervened (yes/no). The scale ranged from 0% (did not intervene anytime) to 100% (intervened every time).|6 months||||percent score on a scale||Standard Error|Mean
2626149|NCT01903863|Secondary|Fresh Frozen Plasma Transfusion Requirements|Compared fresh frozen plasma transfusion during ECMO for control versus treatment group|ECMO course (median 198 hours)||||ml/kilogram/ECMO day||Inter-Quartile Range|Median
2626150|NCT01903863|Secondary|Platelets Transfusion Requirement|Compared platelet transfusion during ECMO for control versus treatment group|ECMO course (median 198 hours)||||ml/kilogram/ECMO day||Inter-Quartile Range|Median
2626151|NCT01903863|Secondary|Time to Therapeutic aPTT|Compared time in hours to goal aPTT for control versus treatment group|ECMO course (median 198 hours)||||hours||Inter-Quartile Range|Median
2626156|NCT01903863|Primary|ECMO Pump Longevity|The primary endpoint is the ECMO pump longevity (measured in hours). The life of the circuit was defined as start of that circuit to circuit change or decannulation from ECMO for each patient. Circuit life was measured in hours|ECMO course (median 198 hours)||||hours||Inter-Quartile Range|Median
2626157|NCT01903811|Other Pre-specified|Incidence of CR by PET, Defined as the Disappearance of All Focal Lesions and the Resolution of EMD|Univariate and multivariate logistic regression will be used to determine the impact of biochemical CR on CR by PET. In the multivariate analysis adjustment for standard prognostic factors such as age, albumin, beta-2 microglobulin, serum creatinine, c-reactive protein and lactate dehydrogenase will be included.|Up to week 45|||||||
2626158|NCT01903811|Other Pre-specified|Gene Expression Profiles|Bone marrow compared to that of an aspirate taken at the site of the EMP. Data will be log-transformed before analysis. Exploratory analyses will examine underlying distributions using boxplots, density plots, scatter plots, etc. For differential expression analysis of the two sample types t-tests will be conducted on genes. False discovery rate will be used to control the average false positive proportions among selected genes. Genes will be ranked by their q-value and pathway analysis conducted upon selected genes to determine biological plausibility and relevance to molecular functionality.|Up to 3 years|||||||
2626159|NCT01903811|Secondary|Overall Survival Crossover Group|Assessed in the crossover arm using the method of Kaplan Meier.|From date of crossover to date of death due to any cause, assessed up to 3 years from randomization||||months||95% Confidence Interval|Median
2626160|NCT01903811|Secondary|Progression-free Survival of Crossover Group|Assessed in the crossover arm using the method of Kaplan Meier. Progression is defined using the International Uniform Response Criteria for Multiple Myeloma as new or increase in size of existing bone lesions or soft tissue plasmacytomas; or development of hypercalcemia attributable solely to MM; or ≥ 25% increase from baseline or lowest response level of either serum M protein, urine M protein, difference in involved & uninvolved serum free light chain level or bone marrow plasma cell percentage.|From date of crossover to date of subsequent documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years from randomization|Patients on Arm 1 that progress after the start of course 2 and prior to completion of 12 courses receive high dose carfilzomib|||months||95% Confidence Interval|Median
2626161|NCT01903811|Secondary|Best Overall Response - Partial Response (PR), Very Good Partial Response (VGPR), Unconfirmed PR (uPR), Stable Disease (SD) Progression (PROG)|Per International Uniform Response Criteria for Multiple Myeloma PR- ≥ 50% reduction in size of soft tissue plasmacytomas & plasma cells; ≥ 50% decrease in serum & reduction in urine M protein ≥ 90% or to < 200 mg/24hr or ≥ 50% decrease in difference in uninvolved & involved serum free light chain levels; VGPR- PR + Serum and urine M proteins detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M protein & urine M protein < 100 mg/24 hrs; uPR- 1 objective status of PR, but confirmation studies are not done, or do not meet the requirements necessary to confirm response; SD- does not meet criteria for sCR, CR, VGPR, PR or PROG; PROG- new or increase in size of existing bone lesions or soft tissue plasmacytomas/ development of hypercalcemia attributable solely to MM/ ≥ 25% increase from baseline/ lowest response level of either serum or Urine M protein, difference in involved & uninvolved serum free light chain level or bone marrow plasma cell percentage.|From date of registration to date of best response while on study treatment|This population includes eligible and analyzable patients who had a follow-up response assessment.|||Participants|||Count of Participants
2626162|NCT01903811|Secondary|Overall Survival|Assessed in each arm using the method of Kaplan Meier and compared between arms using the stratified log-rank test.|From date of registration to date of death due to any cause, assessed up to 3 years|Participants that were eligible and analyzable per protocol.|||months||95% Confidence Interval|Median
2626163|NCT01903811|Primary|Progression-free Survival|Assessed in each arm using the method of Kaplan Meier and compared between arms using the stratified long-rank test. Progression is defined using the International Uniform Response Criteria for Multiple Myeloma as new or increase in size of existing bone lesions or soft tissue plasmacytomas; or development of hypercalcemia attributable solely to MM; or ≥ 25% increase from baseline or lowest response level of either serum M protein, urine M protein, difference in involved & uninvolved serum free light chain level or bone marrow plasma cell percentage.|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 2 years|Group of participants that were eligible and analyzable per protocol.|||months||95% Confidence Interval|Median
2626164|NCT01903798|Secondary|Number of Patients Reported Ascites||Week 24|No patient was randomized to Rilonacept +prednisolone arm|||Participants|||Count of Participants
2626165|NCT01903798|Primary|Survival at Day 29 of the Assigned Treatment|"To determine whether treatment with prednisolone + mycophenolate mofetil is better than standard of care treatment among patients with alcoholic hepatitis who fail to respond to 1 week of prednisolone (i.e., Lille score of ≥0.45). Primary outcome is survival at Day 29.~All study participants received the Standard of care (prednisolone) with or without experimental drug at Day 1 (based on randomization). Response to the treatment was determined at Day 8. Data was collected for both responders and non-responders."|Day 8 to Day 29|There was no participant randomized to rilonocept +prednisolone arm|||Participants|||Count of Participants
2626166|NCT01903720|Secondary|Percentage of Participants Who Received Laser Treatments|Participants underwent laser photocoagulation therapy for all areas of foveal leakage and non-perfusion, as well as areas of extensive retinal hyperplasia if applicable for rescue therapy.|12 Months|ITT population included all enrolled participants.|||percentage of participants|||Number
2626167|NCT01903720|Secondary|Time to Third Injection|Time in weeks from the second injection to the third injection.|12 Months|ITT population included all enrolled participants.|||weeks||Standard Deviation|Mean
2626168|NCT01903720|Secondary|Time to Second Injection|Time in weeks from the first injection to the second injection.|12 Months|ITT population included all enrolled participants.|||weeks||Standard Deviation|Mean
2626169|NCT01903720|Secondary|Percentage of Participants Receiving a Third Injection||12 Months|ITT population included all enrolled participants.|||percentage of participants|||Number
2626170|NCT01903720|Secondary|Percentage of Participants Receiving a Second Injection||12 Months|ITT population included all enrolled participants.|||percentage of participants|||Number
2626171|NCT01903720|Secondary|Percentage of Participants With a Change From Baseline of 15 or More Letters in BCVA|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). An increase in the number of letters read correctly means that the vision improved and a decrease in the number of letters read correctly means that the vision has worsened.|Baseline, Months 6 and 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available at the given time-point for analysis."|||percentage of participants|||Number
2626172|NCT01903720|Secondary|Change From Baseline in CRT at Each Visit|CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.|Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available at the given time-point for analysis."|||micrometers (μm)||Standard Deviation|Mean
2626173|NCT01903720|Secondary|Change From Baseline in BCVA at Each Visit|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.|Baseline, Week 1, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available at the given time-point for analysis."|||letters||Standard Deviation|Mean
2626174|NCT01903720|Secondary|Change From Baseline in CRT at Month 12|CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.|Baseline, Month 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available for analysis."|||μm||Standard Deviation|Mean
2626175|NCT01903720|Secondary|Change From Baseline in BCVA at Month 12|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.|Baseline, Month 12|"ITT population included all enrolled participants. n in the category is the number of participants with data available for analysis."|||letters||Standard Deviation|Mean
2626176|NCT01903720|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Month 6|CRT was measured in the study eye using optical computed tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina. A negative change from Baseline indicates an improvement.|Baseline, Month 6|"ITT population included all enrolled participants. n in the category is the number of participants with data available for analysis."|||micrometers (μm)||Standard Deviation|Mean
2626177|NCT01903720|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 6|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly ranging from 0 (worst) to 100 letters (best). A positive number change in the number of letters read correctly means that the vision improved and a negative number change in the number of letters read correctly means that the vision has worsened.|Baseline, Month 6|"Intent-to-treat (ITT) population included all enrolled participants. n in the category is the number of participants with data available for analysis."|||letters||Standard Deviation|Mean
2626178|NCT01903564|Secondary|Percentage of Fetuses With a Family History of Long QT Syndrome Who Had a Change in Management Due to fMCG|Percentage of fetuses with a family history of long QT syndrome who had a change in management due to fMCG|15 weeks' gestation to birth|Fetuses with a family history of fetal long QT syndrome|||Participants|||Count of Participants
2626179|NCT01903564|Secondary|Percentage of Fetuses With a Family History of Long QT Syndrome Who a Change in Diagnosis Due to fMCG|Percentage of fetuses with a family history of long QT syndrome who a change in diagnosis due to fMCG|15 weeks' gestation to birth|Fetuses with family history of LQTS|||Participants|||Count of Participants
2626180|NCT01903564|Primary|Percentage of Subjects Experiencing Adverse Events Related to Device|Percentage of Subjects Experiencing Adverse Events Related to Device|15 weeks' gestation till up to 1 month after birth||||Participants|||Count of Participants
2626181|NCT01903564|Primary|Number of Participants With Concordance of fMCG and Postnatal ECG for Diagnosis of Long QT Syndrome|Number of Participants with Concordance of fMCG and Postnatal ECG for Diagnosis of Long QT Syndrome based on measurement of rate-corrected QT interval (QTc)|Birth to age 1 week|Fetuses with a family history of long QT syndrome|||Participants|||Count of Participants
2626182|NCT01903564|Primary|Percentage of Subjects Experiencing Adverse Events Unrelated to Device|Percentage of subjects experiencing adverse events unrelated to device|15 weeks' gestation till up to 1 month after birth||||Participants|||Count of Participants
2626183|NCT01903564|Primary|Percentage of Subjects Experiencing Symptoms|Percentage of subjects experiencing symptoms|15-40 weeks' gestation|Symptoms include premature labor, vaginal bleeding, uterine cramping, nausea/vomiting, dizziness, dsypnea, syncope, palpitations, or fatigue during the study session.|||Participants|||Count of Participants
2626184|NCT01903460|Secondary|Change From Baseline to Week 13 (End of Treatment) in Pruritus as Measured by The Patient And Observer Itch Reported Outcome (ItchRO) Average Daily Scores|The ItchRO was administered as a twice daily electronic diary (eDiary). Children ≥9 years of age completed the patient ItchRO; those between the ages of 5 and 8 completed the patient ItchRO with the assistance of their caregiver. There was no patient report for subjects under the age of 5. ItchRO scores range from 0 to 4, with the higher score indicating increasing itch severity. ItchRO average daily scores were calculated as the sum of daily scores (ie, the maximum of morning and evening scores) divided by the number of days. The average daily score was calculated by using the 7 days pre-treatment for baseline, and the last 7 days of treatment for Week 13. A negative change from Baseline indicates that itch severity decreased.|Baseline to 13 weeks or end of treatment|The mITT population, defined as all participants in the Safety population who had at least 1 post-baseline efficacy assessment. The Safety population was defined as all participants who were randomly assigned to study treatment and who received any amount of study drug.|||units on a scale||Standard Error|Least Squares Mean
2626185|NCT01903460|Secondary|Change From Baseline to Week 13 (End of Treatment) in Liver Enzymes|Analysis of liver enzymes included alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP). A negative change from baseline indicates that the level of that enzyme decreased.|Baseline to 13 weeks or end of treatment|The mITT population, defined as all participants in the Safety population who had at least 1 post-baseline efficacy assessment. The Safety population was defined as all participants who were randomly assigned to study treatment and who received any amount of study drug.|||U/L||Standard Error|Least Squares Mean
2626186|NCT01903460|Primary|Change From Baseline to Week 13 (End of Treatment) in Fasting Serum Bile Acid Level|Participants were required to fast for at least 4 hours; only water was permitted prior to collection. A negative change from baseline indicates that the level of bile acid decreased.|Baseline to 13 weeks or end of treatment|The modified Intent-to-Treat (mITT) population, defined as all participants in the Safety population who had at least 1 post-baseline efficacy assessment. The Safety population was defined as all participants who were randomly assigned to study treatment and who received any amount of study drug.|||umol/L||Standard Error|Least Squares Mean
2626187|NCT01903434|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (LY2484595)|Evacetrapib exposure in terms of Area Under the Concentration Versus Time Curve from time 0 extrapolated to infinity (AUC[0-∞]) is summarized for each solid fraction control (Reference and Test).|Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each period|Participants who received at least 1 dose of evacetrapib and had evaluable evacetrapib concentration data.|||nanograms times hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
2626188|NCT01903434|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib (LY2484595)|The maximum observed drug concentration (Cmax) of evacetrapib is summarized for each solid fraction control (Reference and Test).|Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each period|Participants who received at least 1 dose of evacetrapib and had evaluable evacetrapib concentration data.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2626189|NCT01903356|Primary|Incidence Rate of Adverse Events (AE)|The incidence rate is the number of new cases per population at risk in a given time period. The incidence rate was calculated in patients who take at least one Trajenta Duo|Up to 26 weeks|Safety Analysis Set: This analysis set included all subjects except subjects violating inclusion/exclusion criteria, dosage adminstration or were lost to follow up.|||Percentage of patients (%)|||Number
2626190|NCT01903356|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment.|This outcome has measured difference between Fasting Plasma Glucose (FPG) values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication.|24 Weeks|Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks.|||Milligram/deciLitre (mg/dL)||Standard Deviation|Mean
2626191|NCT01903356|Secondary|Relative Effectiveness Response Rate|Occurrence of relative effectiveness response. This outcome measures percentage of patients for which HbA1c has reduced by at least 0.5% after 24 weeks.|24 Weeks|Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks.|||Percentage of patients (%)|||Number
2626192|NCT01903356|Secondary|Target Effectiveness Response Rate|Occurrence of treatment to target effectiveness response is an HbA1c under treatment of < 6.5% after 24 weeks of treatment. This outcome measures percentage of patients achieving HbA1c < 6.5% after 24 weeks.|24 Weeks|Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks.|||Percentage of Patients (%)|||Number
2626193|NCT01903356|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) After 24 Weeks of Treatment.|This outcome has measured difference between HbA1c values from baseline to 24 weeks post treatment. The term 'baseline' refers to the last observation prior to the administration of any study medication. HbA1c is a form of hemoglobin, a blood pigment that carries oxygen, which is bound to glucose. The term HbA1c also refers to glycated hemoglobin. High levels of HbA1c (Normal range is less than 6%) indicate poorer control of diabetes than level in normal range.|Baseline and Week 24|Effectiveness Analysis Set: This analysis set included all subjects from safety analysis set for whom HbA1c was recorded before administration of treatment and at least once after treatment for at least 10 weeks.|||Percentage (%) of HbA1c||Standard Deviation|Mean
2626194|NCT01903265|Secondary|Change From Baseline to Week 12 in FIQ-R Total Score|"The Fibromyalgia Impact Questionnaire (revised) FIQ-R is made up of 3 domains: functional (9 questions), overall (2 questions) and symptoms (10 questions). All questions are based on an 11-point numerical rating scale (NRS) of 0-10, with 10 being worst. Total FIQ-R scores can range from 0-100, with higher scores reflecting worsening status. The patient's total score on the FIQ-R was assessed at Visits 2, 3, 4, 5, and 6 (Week 12). Jump to control was used to replace missing data in each treatment arm."|Baseline, Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients|||units on a scale||Standard Error|Least Squares Mean
2626195|NCT01903265|Secondary|"Patient Global Impression of Change (PGIC) Responder Status (Very Much Improved or Much Improved vs All Other Categories) at Week 12"|The PGIC is a 7-point scale (1=very much improved; 7=very much worse) that assesses the patient's perception of the overall change in his/her fibromyalgia symptoms since entering the study. Scores of 1 and 2 were considered responders.|Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients|||percentage of participants|||Number
2626216|NCT01903252|Secondary|Period 1: Change in Stool Frequency Score|Between-Group Difference of Stool Frequency Score, Change from Baseline The changes from baseline to week 8 values in stool frequency will be compared between the two treatment groups. Values for stool frequency range between 0 and 3. A value of 0 indicates normal stool frequency, a value of 3 indicates 5 or more stools than normal. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between week 8 values and baselines indicates treatment success.|Baseline and Week 8|Per Protocol|||units on a scale||Standard Deviation|Mean
2626196|NCT01903265|Secondary|Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance|The Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance instrument consists of 8 items in which responses are scored 1 to 5 for each item. A higher score on 5 of the 8 items reflects a worse outcome, whereas a higher score on 3 items reflects an improved outcome; therefore, the directionality of the 8 item scores are first synchronized prior to calculation of the total raw score. PROMIS scores are presented as T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured (in this case, sleep disturbance).|Baseline, Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients|||units on a scale||Standard Error|Least Squares Mean
2626197|NCT01903265|Secondary|30% Responder Analysis of IVRS NRS Pain Assessments at Week 12|"The weekly averages of daily pain scores were calculated using the daily, 24-hour-recall, IVRS NRS pain assessments.~Patients who had at least a 30% improvement from baseline to week 12 in weekly average of daily pain scores were considered responders."|Baseline, Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients.|||percentage of participants|||Number
2626198|NCT01903265|Primary|Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12|Daily pain scores were assessed using a 24-hour recall response provided by each patient via an interactive voice response system (IVRS) daily telephone diary. Average daily pain was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse pain. Jump to control was used to replace missing data in each treatment arm.|Baseline, Week 12|Patients in the Intention-to-treat (ITT) population: all randomized patients|||units on a scale||Standard Error|Least Squares Mean
2626199|NCT01903252|Secondary|Period 3: UC-Related Complications|Percentage of Patients with Complications related to UC|Week 38|Intent to Treat|||Participants|||Count of Participants
2626200|NCT01903252|Secondary|Period 3: No Urgency|No urgency is a score of 0 and indicates that patients did not report urgency during any of the three days prior to the visit at week 38. A score of 1 indicates that urgency was reported during any of these three days.|Week 38|Intent to Treat|||Participants|||Count of Participants
2626201|NCT01903252|Secondary|Period 3: Stool Frequency Sub-score 0|Patients achieving a Stool Frequency sub-score of 0|Week 38|Intent to Treat|||Participants|||Count of Participants
2626202|NCT01903252|Secondary|Period 3: Rectal Bleeding Sub Score of 0|Percentage of each dose group achieving the endpoint rectal bleeding subscore 0|Week 38|Intent to Treat|||percentage of participants|||Number
2626203|NCT01903252|Secondary|Period 3: Endoscopic Response|Endoscopic response was define as a reduction in the Mayo endoscopic sub score of at least one.|Week 38|Intent to Treat|||percentage of participants|||Number
2626204|NCT01903252|Secondary|Period 3: Endoscopic Remission|Percentage of each dose group achieving an endoscopy sub score of 0|Week 38|Intent to Treat|||percentage of participants|||Number
2626205|NCT01903252|Secondary|Period 3: Clinical and Endoscopic Response|Both has to be achieved, Clinical and Endoscopic Response which is defined by a decrease from baseline in the Mayo score of ≥ 3 points and > 30% of the baseline score, with an accompanying decrease in the rectal bleeding sub-score of ≥ 1 point or an absolute rectal bleeding sub-score of 0 or 1.|Week 38|Intent to Treat|||percentage of participants|||Number
2626206|NCT01903252|Secondary|Period 3: Clinical and Endoscopic Remission|Mayo Score of <= 2 points with no individual sub-score > 1|Week 38|Intent to Treat|||percentage of participants|||Number
2626207|NCT01903252|Secondary|Period 3: Clinical Response|A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.|Week 38|Intent to Treat|||percentage of participants|||Number
2626208|NCT01903252|Secondary|Period 2: UC-Related Complications|Percentage of Patients Experiencing Complications related to UC|Week 16|Intent to Treat|||Participants|||Count of Participants
2626209|NCT01903252|Secondary|Period 2: Urgency|Percentage of patients achieving an Urgency Score of 0. A score of 0 indicates no urgency reported in any of the three days prior to the visit at week 16. A score of 1 indicates urgency reported in any of the three days prior to the visits.|Week 16|Indent to Treat|||Participants|||Count of Participants
2626210|NCT01903252|Secondary|Period 2: Stool Frequency 0|Percentage of patients achieving the endpoint stool frequency sub-score of 0|Week 16|Intent to Treat|||Participants|||Count of Participants
2626211|NCT01903252|Secondary|Period 2: Rectal Bleeding Sub-score of 0|Percentage of patients achieving the endpoint rectal bleeding sub-score of 0|Week 16|Intent to treat|||Participants|||Count of Participants
2626212|NCT01903252|Secondary|Period 2: Clinical Remission|Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)|Week 16|Intent to Treat|||Participants|||Count of Participants
2626213|NCT01903252|Secondary|Period 1: Change in Endoscopic Score From Baseline|Between-Group Difference of Endoscopic Score, Change from Baseline. The changes from baseline to week 8 values in sigmoidoscopic (mucosal) appearance scores will be compared between the two treatment groups. A value of 0 in the endoscopic score means normal or inactive disease and a value of 3 means severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between baseline to week 8 indicates treatment success.|Baseline and Week 8|Per Protocol|||units on a scale||Standard Deviation|Mean
2626214|NCT01903252|Secondary|Period 1: Change in Physician Global Assessment Score From Baseline|"Between-Group Difference of Physician Global Assessment Score, Change from Baseline.~The changes from baseline to week 8 values in the Physician Global Assessment score will be compared between the two treatment groups. A value of 0 means no pathology and a value of 3 means severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference between baseline to week 8 indicates treatment success."|Baseline and Week 8|Per Protocol|||units on a scale||Standard Deviation|Mean
2626215|NCT01903252|Secondary|Period 1: Change in Rectal Bleeding Score From Baseline|Between-Group Difference of Rectal Bleeding Score, Change from Baseline The changes from baseline to week 8 values in rectal bleeding scores will be compared between the two treatment groups. A value of 0 indicates no rectal bleeding, a value of 3 indicates only blood is passing. Change from Baseline is calculated Baseline-score minus week 8-score. A large difference at week 8 compared to baseline is indicative of treatment success.|Baseline and Week 8|Per Protocol|||units on a scale||Standard Deviation|Mean
2626217|NCT01903252|Secondary|Period 1: Change in Partial Mayo Score From Baseline|Between-Group Difference of Partial Mayo Score, Change from Baseline to Week 8 The Partial Mayo Score is the sum of the component sub-scores, 1) stool frequency, 2) rectal bleeding and 3) physician's global assessment. A partial Mayo Score of 0 indicates no disease and a maximum score of 9 indicates severe symptoms. Change from Baseline is calculated Baseline-score minus week 8-score. A larger change in Partial Mayo Score from Baseline where patients experienced acute disease, indicates improvement and treatment success.|Baseline and Week 8|Per Protocol|||units on a scale||Standard Deviation|Mean
2626218|NCT01903252|Secondary|Period 1: Change in Mayo Score From Baseline|"Between-Group Difference of Mayo Score, Change from Baseline The changes from baseline to week 8 values in Mayo scores are compared between the two treatment groups.~The Mayo scoring system is a well-established tool for assessing UC disease activity. The Mayo score is the sum of 4 component sub-scores, each scored on a scale ranging from 0 representing no pathology to 3 for severe disease. The 4 component sub-scores consist of, 1) stool frequency, 2) rectal bleeding, 3) flexible sigmoidoscopy scores, and 4) physician's global assessment. A Mayo score of 0 indicates no pathology and a score of 12, severe disease. Change from Baseline is calculated Baseline-score minus week 8-score. A larger change in Mayo score from baseline when patients experienced acute disease, indicates improvement and treatment success."|Baseline and Week 8|Per Protocol|||units on a scale||Standard Deviation|Mean
2626219|NCT01903252|Secondary|Period 1: Clinical Response at Both Week 8 and Week 12|A decrease in the Partial Mayo Score of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.|Week 8 and Week 12|Per Protocol|||Participants|||Count of Participants
2626220|NCT01903252|Secondary|Period 1: Clinical Remission at Both Week 8 and 12|Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)|Week 8 and week 12|Per Protocol|||Participants|||Count of Participants
2626221|NCT01903252|Secondary|Period 1: Rectal Bleeding Score of 0|Rectal bleeding sub-score of 0 was defined as a sub score on the rectal bleeding component of the Mayo score|Week 12|Per Protocol|||Participants|||Count of Participants
2626222|NCT01903252|Secondary|Period 1: Clinical Response|A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.|Week 12|Per protocol|||Participants|||Count of Participants
2626223|NCT01903252|Secondary|Period 1: Clinical Remission|Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)|Week 12|Per Protocol|||Participants|||Count of Participants
2626224|NCT01903252|Secondary|Period 1: Clinical and Endoscopic Response|Clinical and Endoscopic Response was defined as a decrease in the Mayo score of ≥3 points from baseline and a reduction of ≥ 30% from baseline with either an accompanying decrease in the rectal bleeding sub-score of at least 1 point or an absolute rectal bleeding sub-score of 0 or 1 at the Week 8 visit. If a subject withdrew from the study prior to Week 8 or their response status was not evaluable due to incomplete and/or invalid data, the subject was considered a non-responder.|Week 8|Per Protocol|||Participants|||Count of Participants
2626225|NCT01903252|Secondary|Period 1: Rectal Bleeding Sub-score of 0|Rectal bleeding sub-score of 0 was defined as a sub score on the rectal bleeding component of the Mayo score|Week 8|Per Protocol|||Participants|||Count of Participants
2626226|NCT01903252|Secondary|Period 1: Clinical Remission|Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)|Week 8|Per Protocol|||Participants|||Count of Participants
2626227|NCT01903252|Secondary|Period 1: Endoscopic Response|Endoscopic response was define as a reduction in the Mayo endoscopic sub score of at least one.|Week 8|Per Protocol|||Participants|||Count of Participants
2626228|NCT01903252|Secondary|Period 1: Endoscopic Remission|Endoscopic remission was defined as a Mayo endoscopy subscore of 0|Week 8|Per Protocol|||Participants|||Count of Participants
2626229|NCT01903252|Primary|Period 3: Clinical Remission|Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS)|Week 38|Intent to Treat|||percentage of participant|||Number
2626230|NCT01903252|Primary|Period 2: Clinical Response, Open-Label Extended Induction|A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0.|Week 16|Intent to Treat|||Participants|||Count of Participants
2626231|NCT01903252|Primary|Period 1: Clinical and Endoscopic Remission|Mayo Score of <= 2 points with no individual sub-score > 1|Week 8|Per Protocol|||Participants|||Count of Participants
2626232|NCT01903187|Secondary|Reduction in Ambulatory Blood Pressure (ABP) Parameters|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.|baseline, 6 months post randomization, and all follow-up timepoints|All subjects|||mmHg||Standard Deviation|Mean
2626233|NCT01903187|Secondary|Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.|6 months post randomization, and all follow-up timepoints|Subjects who received renal denervation|||Participants|||Count of Participants
2626234|NCT01903187|Secondary|The Number of Subjects That Experience Each Type of MAE|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.|6 months post randomization|Subjects who received renal denervation|||Participants|||Count of Participants
2626286|NCT01902459|Other Pre-specified|This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation.|This product is easy to cut to size for application on various sized bleeding sites e.g., a customized preparation.|Intraoperative||||Participants|||Number
2626235|NCT01903187|Secondary|Device or Procedure Related Adverse Events by Severity Post Randomization Through Six (6) Months|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.|6 months post randomization|Subjects who received renal denervation|||Participants|||Count of Participants
2626236|NCT01903187|Primary|The Primary Effectiveness Endpoint is the Reduction of Office Systolic Blood Pressure (OSBP) at Six (6) Months Post Randomization Compared to Baseline Between Groups||6 months post randomization|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct a comparison between groups.|||mmHg||Standard Deviation|Mean
2626237|NCT01903187|Primary|The Primary Safety Endpoint Will be the Proportion of Subjects Who Experience Any Major Adverse Event (MAE) as Adjudicated by the Clinical Event Committee (CEC).|The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred.|6 months post randomization|All subjects randomized to the EnligHTN procedure|||percentage of participants|||Number
2626238|NCT01903148|Secondary|Patients With Hb<11||1 day||||participants|||Number
2626239|NCT01903148|Secondary|Iron Treatment|Patients with supplementary Iron treatment to ESA|1 day||||participants|||Number
2626240|NCT01903148|Secondary|% Patients With Erythropoiesis Stimulating Agents (ESA) Therapy|know the treatments ESA for maintenance of hb levels|1 day||||percentage of participants|||Number
2626241|NCT01903148|Secondary|Patients With Hb>12||1 day||||participants|||Number
2626242|NCT01903148|Secondary|Hemoglobin Levels Per Type of Patients|levels Hb and type of patients|1 day|n represents the number of participants analyzed for each category respectively (converted patients, naïve patients)|||mg/dl||Standard Deviation|Mean
2626243|NCT01903148|Primary|% Patients Achieving Target Hemoglobin Levels|% patients with Hb levels between 11-12 mg/dl|1 day because is a crosssectional study with only a visit||||percentage of participants|||Number
2626244|NCT01903031|Secondary|Proportion of Participants With Progesterone Levels Greater Than 5 ng/mL.|This evaluates alterations in progesterone levels due to the potential PK interaction between NuvaRing and the ARVs EFV and ATV/r by examining progesterone levels at study days 0 (before vaginal ring placement), 7, 14, and 21 (before vaginal ring removal), and study day 28, without regard to menstrual cycle status at study entry.|Study days 0, 7, 14, 21 and 28|All participants included in the primary analyses who had progesterone data available. One participant on the EFV arm is excluded at day 14 visit because NuvaRing was out of the body for >3 hours leading up to the visit.|||proportion of participants||95% Confidence Interval|Number
2626245|NCT01903031|Secondary|Percentage of Participants With Signs and Symptoms of Grade 2 or Higher Deemed Possibly, Probably or Definitely Related to Study Treatment|This evaluates toxicity and safety of NuvaRing alone, NuvaRing with EFV, and NuvaRing with ATV/r. Signs/symptoms were graded using the DAIDS AE Grading Table was used. Participants with sign(s)/symptom(s) of grade 2 (moderate), 3 (severe), 4 (potentially life-threatening) or 5 (death) are included in the percentage. Relationship to study treatment was determined by the study co-chairs and DAIDS clinical representative.|From day 0 to day 28|All participants in whom NuvaRing was inserted|||Percent of Participants|||Number
2626246|NCT01903031|Secondary|Proportion of Participants With Plasma HIV-1 RNA Levels <40 Copies/mL|This evaluates the short-term impact of Nuvaring on virologic suppression in participants who have been administered Nuvaring alone or together with EFV or ATV/r by measuring proportion of participants with plasma HIV-1 RNA levels <40 copies/mL at study day 0 (before vaginal ring placement) and study day 21 (three weeks after vaginal ring placement). An FDA-approved HIV-1 RNA assay was required.|Study day 0 and study day 21|All participants in whom NuvaRing was inserted and with HIV-1 RNA data available.|||proportion of participants||95% Confidence Interval|Number
2626247|NCT01903031|Secondary|RTV PK Parameter CLss/F Determined Based on RTV Levels From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the PK parameter CLss/F of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/F defines apparent oral clearance.|Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of RTV PK parameters.|||hour||Full Range|Median
2626248|NCT01903031|Secondary|RTV PK Parameter Tmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the PK parameter Tmax of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Tmax defines time to maximum concentration since dose is initiated.|Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of RTV PK parameters.|||hour||Full Range|Median
2626249|NCT01903031|Secondary|RTV PK Parameter Cmax Determined Based on RTV Levels From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the PK parameter Cmax of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval.|Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of RTV PK parameters.|||ng/mL||Full Range|Median
2626287|NCT01902459|Other Pre-specified|This Product is Easy to Apply to a Variety of Bleeding Sites.|This product is easy to apply to a variety of bleeding sites.|Intraoperative||||Participants|||Number
2626288|NCT01902459|Other Pre-specified|This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site.|This product is easy and quick to prepare for application to the target bleeding site.|Intraoperative||||Participants|||Number
2626250|NCT01903031|Secondary|RTV PK Parameter Cmin Determined Based on RTV Levels From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the PK parameter Cmin of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval.|Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of RTV PK parameters.|||ng/mL||Full Range|Median
2626251|NCT01903031|Secondary|Ritonavir (RTV) PK Parameter AUC(0-24h) Calculated Based on Intensive RTV PK Samples Obtained From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of RTV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h).|Intensive RTV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of RTV PK parameters.|||h*ng/mL||Full Range|Median
2626252|NCT01903031|Secondary|ATV PK Parameter CLss/F Determined Based on ATV Levels From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the ATV PK parameter CLss/F obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/f defines apparent oral clearance.|Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of ATV PK parameters.|||L/h||Full Range|Median
2626253|NCT01903031|Secondary|ATV PK Parameter Time to Cmax (Tmax) Determined Based on ATV Levels From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the ATV PK parameter Tmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Tmax defines time to maximum concentration since dose is initiated.|Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of ATV PK parameters.|||hour||Full Range|Median
2626254|NCT01903031|Secondary|ATV PK Parameter Cmax Determined Based on ATV Levels From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the ATV PK parameter Cmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval.|Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of ATV PK parameters.|||ng/mL||Full Range|Median
2626255|NCT01903031|Secondary|ATV PK Parameter Cmin Determined Based on ATV Levels From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the ATV PK parameter Cmin obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval.|Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of ATV PK parameters.|||ng/mL||Full Range|Median
2626256|NCT01903031|Secondary|ATV PK Parameter AUC(0-24h) Calculated Based on Intensive Atazanavir (ATV) PK Samples Obtained From Individual Participants Enrolled in Arm C|This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of ATV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h).|Intensive ATV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement)|The analysis population is the 23 A5316 participants enrolled in Arm C (NuvaRing with ATV/r arm plus TDF and one or more NRTIs) eligible for the secondary outcome of ATV PK parameters.|||h*ng/mL||Full Range|Median
2626257|NCT01903031|Secondary|EFV PK Parameter Clearance (CLss/F) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B|This evaluates the effect of NuvaRing on the EFV PK parameter CLss/F obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. CLss/F defines apparent oral clearance|Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).|The analysis population is the 24 A5316 participants enrolled in Arm B (NuvaRing with EFV arm plus 2 or more NRTIs) eligible for the secondary outcome of EFV PK parameters.|||L/h||Full Range|Median
2626258|NCT01903031|Secondary|EFV PK Parameter Maximum Plasma Concentration (Cmax) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B|This evaluates the effect of NuvaRing on the EFV PK parameter Cmax obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmax defines maximum concentration observed within the first 8 hours of the 24 hour dosing interval.|Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).|The analysis population is the 24 A5316 participants enrolled in Arm B (NuvaRing with EFV arm plus 2 or more NRTIs) eligible for the secondary outcome of EFV PK parameters.|||ng/mL||Full Range|Median
2626259|NCT01903031|Secondary|EFV PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on EFV Levels From Individual Participants Enrolled in Arm B|This evaluates the effect of NuvaRing on the EFV PK parameter Cmin obtained from both sampling periods, before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. Cmin defines minimum concentration observed within the first 8 hours of the 24 hour dosing interval.|Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).|The analysis population is the 24 A5316 participants enrolled in Arm B (NuvaRing with EFV arm plus 2 or more NRTIs) eligible for the secondary outcome of EFV PK parameters.|||ng/mL||Full Range|Median
2626260|NCT01903031|Secondary|EFV PK Parameter Area Under the Concentration-Time Curve (AUC0-24hours) Calculated Based on Intensive EFV PK Samples Obtained From Individual Participants Enrolled in Arm B|This evaluates the effect of NuvaRing on the PK parameter AUC(0-24h) of EFV before NuvaRing placement (at study day 0) and three weeks later (on study day 21), prior to NuvaRing removal. AUC(0-24h) defines area under the concentration-time curve over the period of 24 hours (pre-dose concentration was used to impute concentration at 24h).|Intensive EFV PK samples at pre-dose, 1, 3, 4, 5, and 8 hours post-dose on study day 0 (before vaginal ring placement) and on study day 21 (3 weeks after vaginal ring placement).|The analysis population is the 24 A5316 participants enrolled in Arm B (NuvaRing with EFV arm plus 2 or more NRTIs) eligible for the secondary outcome of EFV PK parameters.|||h*ng/mL||Full Range|Median
2626261|NCT01903031|Secondary|Ethinyl Estradiol Concentrations Obtained on Study Days 7 and 14.|This evaluates the effect of EFV and ATV/r on ethinyl estradiol by measuring ethinyl estradiol concentrations on all three study arms 7 and 14 days after NuvaRing administration. The assay lower limit of quantification for ethinyl estradiol was 5 pg/mL; values < 5 were assigned a value of half the lower limit (ie, 2.5 pg/mL).|Study days 7 and 14|Participants who provided the Ethinyl estradiol PK samples at day 7 and at day 14 were included in the analysis.|||pg/mL||Full Range|Median
2626262|NCT01903031|Secondary|Etonogestrel Concentrations Obtained on Study Days 7 and 14|This evaluates the effect of EFV and ATV/r on etonogestrel by measuring etonogestrel concentrations on all three study arms 7 and 14 days after NuvaRing administration. The assay lower limit of quantification for etonogestrel was 250 pg/mL; values < 250 were assigned a value of half the lower limit (ie, 125 pg/mL).|Study days 7 and 14|Participants who provided the Etonogestrel PK samples at day 7 and at day 14 were included in the analysis.|||pg/mL||Full Range|Median
2626263|NCT01903031|Primary|Ethinyl Estradiol Concentrations at Study Day 21|This evaluates the effect of EFV and ATV/r on ethinyl estradiol by measuring ethinyl estradiol concentrations on all three study arms 21 days after NuvaRing administration. The PK blood sample for measurement of ethinyl estradiol on study day 21 was taken before the NuvaRing was removed. The assay lower limit of quantification for ethinyl estradiol was 5 pg/mL ; values < 5 were assigned a value of half the lower limit (ie, 2.5 pg/mL).|Day 21|Participants who provided the Ethinyl Estradiol PK sample at day 21 were included in the analysis.|||pg/mL||Full Range|Median
2626264|NCT01903031|Primary|Etonogestrel Concentrations at Study Day 21|This evaluates the effect of EFV and ATV/r on etonogestrel by measuring etonogestrel concentrations on all three study arms 21 days after NuvaRing administration. The pharmacokinetic (PK) blood sample for measurement of etonogestrel on study day 21 was taken before the NuvaRing was removed. The assay lower limit of quantification for etonogestrel was 250 pg/mL; values < 250 were assigned a value of half the lower limit (ie, 125 pg/mL).|Day 21|Participants who provided the Etonogestrel PK sample at day 21 were included in the analysis.|||pg/mL||Full Range|Median
2626265|NCT01903005|Primary|Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events|Study discontinuations due to treatment-emergent adverse events that occurred during treatment with bioavailability BNX sublingual tablets|Day 1 through week 24|Safety population|||participants|||Number
2626266|NCT01903005|Primary|Number of Patients Reporting Treatment-Emergent Serious Adverse Events|Patients reporting treatment-emergent serious adverse events considered either related or not related to treatment with the higher bioavailability BNX sublingual tablets|Day 1 throught week 24|Safety population|||participants|||Number
2626267|NCT01903005|Primary|Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events|Treatment-emergent adverse events considered related to treatment with the higher bioavailability BNX sublingual tablets|Day 1 through week 24|Safety population|||participants|||Number
2626268|NCT01903005|Primary|Number of Patients Reporting Treatment-Emergent Adverse Events|Number of patients reporting treatment-emergent adverse events during open-label, extension treatment with higher bioavailability BNX sublingual tablets|Day 1 through week 24|Safety population|||participants|||Number
2626269|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP|Mean change from primary study baseline to week 24 of the open-label extension study for questions 5-6 of the WPAI:SHP; Question 5: During the past 7 days, how much did your opioid dependence affect your productivity while you were working?; Question 6: During the past 7 days, how much did your opioid dependence affect your ability to do regular daily activities, other than work at a job?; Questions 5 and 6 of the WPAI:SHP are scored on an 11-point scale (0 = problem had no effect; 10 = problem completely prevented me from doing my work/daily activities)|Week 24|Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed|||units on a scale||95% Confidence Interval|Mean
2626270|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP|Mean change from primary study baseline to week 24 of the open-label, extension study for questions 2-4 of the WPAI:SHP; Question 2: During the past 7 days, how many hours did you miss from work because of problems associated with your opioid dependence?; Question 3: During the past 7 days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study?; Question 4: During the past 7 days, how many hours did you actually work?|Week 24|Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed|||hours||95% Confidence Interval|Mean
2626289|NCT01902459|Primary|Safety Parameter - Incidence of Increase Blood Fibrinogen Level|Number of subjects experiencing an increase in blood fibrinogen from the safety set consisting of all subjects on whom procedure is started.|Surgery up until the 30 day follow-up||||Participants|||Number
2626271|NCT01903005|Secondary|Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP)|"Question 1 of the WPAI:SHP asks patients to provide a yes or no response to the question Are you employed?; The percentage of patients employed at the end of the 24-week open-label, extension study was calculated by subtracting the percentage of previously employed patients not employed at study end from the percentage of previously unemployed patients who were employed by study end"|Study Endpoint|Safety population; patients with missing data were excluded from the analysis and are reflected in the number of patients analyzed|||percentage of patients|||Number
2626272|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores|"Mean change from primary study baseline in VAS craving scores during the 24-week open-label, extension study; VAS craving scores range from 0 (no cravings) to 100 mm (most intense craving I have ever had); study endpoint was defined as the last post-baseline value recorded for VAS craving"|Prior to dosing on day 1, at weeks 4, 8, 12, 16, 20, and 24, and at study endpoint|Safety population; patient population at day 1 (n=646) is lower than overall safety population (n=665) due to missing data|||units on a scale||95% Confidence Interval|Mean
2626273|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score|Mean change from primary study baseline in SOWS total scores during the 24-week open-label, extension study; SOWS scores range from 0 to 64, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for SOWS|Prior to dosing on day 1, at weeks 4, 8,12,16, 20, and 24, and at study endpoint|Safety population; patient population at day 1 (n=650) is lower than overall safety population (n=665) due to missing data|||units on a scale||95% Confidence Interval|Mean
2626274|NCT01903005|Secondary|Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score|Mean change from primary study baseline in COWS total scores during the 24-week open-label, extension study; COWS scores range from 0 to 48, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for COWS|Prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint|Safety population; patient population at day 1 (n=658) is lower than overall safety population (n=665) due to missing data|||units on a scale||95% Confidence Interval|Mean
2626275|NCT01903005|Secondary|Retention in Treatment in the Safety Population|Retention in treatment by visit in the safety population at weeks 4, 8, 12, 16, 20, and 24, defined as the number of patients receiving treatment on the day of the visit (± 5 days for each visit)|Treatment retention was assessed at weeks 4, 8, 12, 16, 20, and 24|Safety population|||participants||95% Confidence Interval|Number
2626276|NCT01902901|Other Pre-specified|Healthcare Utilization|The investigators will evaluate if expanded carrier testing using WGS causes an increase in subsequent health care utilization compared to usual care (typically just cystic fibrosis carrier testing).|The end of Year 4|This data was reported at the end of year 4 for all participants that had at least 6 months of follow-up data.|||Face to face medical encounters||Standard Deviation|Mean
2626277|NCT01902901|Secondary|Patient Satisfaction|Through surveys, interviews, and observations with patients, the investigators will assess their satisfaction with the testing and return of results process.|Assessed annually for 4 years, data at the end of Year 3 reported.|Participants in the usual care arm don't complete satisfaction surveys. Results are WGS arm participants who received genetic testing carrier results in person and reported understanding the information|||Participants|||Count of Participants
2626278|NCT01902901|Primary|Number of Patients That Receive Carrier Testing and Have Results to Return|The investigators will record the number of patients that have both single carrier status testing (usual care) and WGS testing and track how many patients have results to return.|Assessed annually for 4 years, data at the end of the study reported.|All consented participants, including male partners.|||Participants|||Count of Participants
2626279|NCT01902888|Primary|Primary Safety Endpoint: Number of Serious Adverse Events (Related to Initial Procedure or the Device Itself) That Occur Within 30 Days of the Initial Study Procedure.|30 day serious adverse events related to the initial study procedure or the study device.|30 days following initial study procedure|||||||
2626280|NCT01902888|Primary|Primary Efficacy Endpoint: The Number of Patients That do Not Have a Failure of Technical Success or Loss of Primary Patency.|A composite of freedom from failure of technical success or loss of primary patency at 12 months|12 months following initial study procedure|||||||
2626281|NCT01902758|Primary|Time (Minutes) to Complete 2 Miles on a Treadmill||after arriving at high altitude (within 1 hour)||||seconds||Standard Deviation|Mean
2626282|NCT01902628|Secondary|Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. A serious AE is any experience that suggests a significant hazard, contraindication, side effect, or precaution.|Up to 10 months|The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data.|||Participants|||Count of Participants
2626283|NCT01902628|Secondary|Percentage of Participants With MIRCERA Dose Adjustments|Changes in Mircera dose since last visit are reported. The numbers of participants for which data were not reported are also indicated.|Up to 10 months|The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data. Number analyzed indicates number of participants evaluated at specific time points.|||percentage of participants|||Number
2626284|NCT01902628|Secondary|Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10|g/dL = grams per deciliter|Months 8 to 10|The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data.|||percentage of participants|||Number
2626285|NCT01902628|Primary|Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10|g/dL = grams per deciliter|Months 8 to 10|The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data.|||percentage of participants|||Number
2626290|NCT01902459|Primary|Safety Parameter - Incidence of Post-operative Bleeding Events Specifically Related to the Target Bleeding Site (TBS)|Number of subjects experiencing a post-operative bleeding event specifically related to the target bleeding site (TBS) and as reported in the adverse events/serious adverse event safety set. Safety set consisting of all subjects on whom procedure is started.|Surgery up until the 30 day follow-up||||Participants|||Number
2626291|NCT01902459|Primary|Safety Parameter - Incidence of Thromboembolic Events|Number of subjects experiencing a thromboembolic event as reported in the adverse events/serious adverse event safety set. the Safety set consists of all subjects on whom procedure is started.|Surgery up until the 30 day follow-up||||Participants|||Number
2626292|NCT01902303|Secondary|Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by the Participant|"The secondary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the participant. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered aborted or blocked. Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure."|0 -7 days|158 subjects randomized to treatment. 118 subjects used allocated assigned treatment (62 test article and 56 placebo). 7 subjects failed to complete and 111 completed study. For this secondary analysis (self assessments) 53 subjects noted prodrome occurring on Day 0.|||participants with aborted lesions|||Number
2626293|NCT01902303|Primary|Number of Participants for Whom a Recurrent Oral Herpes Episode Initiated With Prodromal Symptoms Were Aborted Before Progressing to a Lesion as Assessed by a Trained Evaluator|"The primary efficacy endpoint of this study is to determine if a recurrent oral herpes episode initiated with prodromal symptoms is aborted before progressing to a lesion (vesicle stage) via assessing lesion stages by the trained evaluator. Any episode of oral herpes that did not reach a vesicle stage or higher by Day 7 (based on evaluator and self-assessments of legion stage) was considered aborted or blocked. Any episode of oral herpes that reached a vesicle stage or higher by Day 7 was considered a treatment failure."|Day 0- Day 7|Participants that did not experience prodrome stage as assessed by the evaluator or met major protocol violations were not included in the PP analysis.|||participants who had aborted lesions|||Number
2626294|NCT01902134|Secondary|Percentage of Responders According to 50% Max TOTPAR (Total Pain Relief)|"Percentage of responders over 8 hours after first dose, according to the 50% maximum total pain relief rule: maximum TOTPAR calculated as the theoretical maximum weighted sum of PAR-VRS (Pain Relief - Verbal Rating Scale: pain relief 0=none, 4=complete) scores.~The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo."|over 8 hours after the first dose||||percentage of participants|||Number
2626295|NCT01902134|Secondary|Percentage of Responders According to PI-VAS (Pain Intensity - Visual Analogue Scale)|"Percentage of responders; response defined as achievement a mean pain intensity, PI-VAS < 40 mm (PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale, 0=no pain to 100=worst pain imaginable),over 48 hours of the multiple-dose phase.~The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL."|over 48 hours of the multiple-dose phase||||percentage of participants|||Number
2626296|NCT01902134|Secondary|SPID48 (Sum of Pain Intensity Differences Over First 48 Hours of the Multiple-dose Phase)|"Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 48 hours of the multiple-dose phase.~PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured every two hours over the first 48 hours of the multiple-dose phase. A higher value in SPID indicates greater pain relief.~The analysis was performed combining all randomization arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL."|over 48 hours of the multiple-dose phase||||units on a scale||Standard Deviation|Mean
2626297|NCT01902134|Primary|SPID8 (Sum of Pain Intensity Differences Over 8 Hours)|"Sum of Pain Intensity Differences calculated as the weighted sum of the PI-VAS differences over 8 hour period. PI-VAS corresponds to the pain intensity measured by a 0-100 visual analogue scale (0=no pain to 100=worst pain imaginable) which was measured at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, and 8h after the first dose. A higher value in SPID indicates greater pain relief.~The analysis was performed combining all randomization arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo."|over 8 hours after the first dose||||units on a scale||Standard Deviation|Mean
2626298|NCT01902004|Other Pre-specified|Number of Participants With Adverse Events|The UKU (Udvalg for Kliniske Undersogelser) Side Effect Rating Scale organizes symptoms into 4 categories (i.e., Psychic, Neurologic, Autonomic, Other) containing 8-19 symptoms each. Each symptom receives a score for degree and causal relationship. Degree is scored between 0-3 with higher scores being more severe. Causal relationship is scored as improbable, possible, or probable.|Measured at 3, 6 months and 12 months|The number of participants with available data at each time point differs due to participant dropout over the course of the study.|||Participants|||Count of Participants
2626299|NCT01902004|Secondary|Change in Cognitive Domain Scores|Neuropsychological battery of tests which included the following domains: learning, delayed recall, and executive functioning. Raw scores were transformed to z-scores for each test score of interest for each participant, and then averaged. These z-scores were averaged within each neuropsychological domain to produce composite scores and then averaged over all tests to calculate a global performance score. Higher scores are indicative of better performance.|Measured at 6 months and 12 months|The number of participants with available data at each time point differs due to participant dropout over the course of the study.|||z score||Standard Deviation|Mean
2626319|NCT01901653|Secondary|Overall Survival|Overall survival (OS) was defined as the time from the first day of study treatment to death. Subjects who were alive were censored at the date of last known alive.|From first dose of Rovalpituzumab tesirine to last event, up through study completion (on average approximately 5-7 months, but up to 14.6 months).|Subjects with at least one post-dose assessment.|||months||95% Confidence Interval|Median
2626300|NCT01902004|Secondary|Change in Montgomery Asberg Depression Rating Scale|Clinician administered item scale measures severity of depressive symptoms. The 10 items are measured on a 7-point scale ranging from 0 to 6; creating a total range of 0-60. A score of 0 suggests absence of symptoms and higher scores represent greater severity of depression.Severity gradations for the MADRS have been proposed (9-17 = mild, 18-34 = moderate, and ≥ 35 = severe). Treatment remission is defined as an endpoint total score ≤ 10.|Measured at 3 months; 6 months and 12 months|The number of participants with available data at each time point differs due to participant dropout over the course of the study.|||units on a scale||Standard Deviation|Mean
2626301|NCT01902004|Primary|Change in Hamilton Depression Rating Scale|Clinician administered scale measures severity of depressive symptoms. This measure includes 24 items. Response options vary item to item and include the following ranges: [0-2], [0-3], and [0-4]. A score of 0 suggests absence of symptoms and/or difficulties and higher scores represent more severe difficulties. Possible overall score range [0-74], higher scores representing more severe difficulties.|Measured at 3 months; 6 months and 12 months|The number of participants with available data at each time point differs due to participant dropout over the course of the study.|||units on a scale||Standard Deviation|Mean
2626302|NCT01901874|Secondary|Target Lesion Revascularization|Any clinically driven revascularization procedure that is performed to increase the luminal diameter inside or within 5 mm of the previously treated lesion|365 days|Per protocol subjects|||Participants|||Count of Participants
2626303|NCT01901874|Secondary|In-Stent Restenosis|≥80% diameter stenosis within the stented lesion or within 5 mm proximal or distal to the stent at follow-up evaluation by core lab angiographic analysis|365 days|Per protocol subjects|||Participants|||Count of Participants
2626304|NCT01901874|Secondary|30-Day MAE - Stroke|Any stroke through 30 days post-index procedure|30 days|Per protocol subjects with 30-day MAE evaluation|||Participants|||Count of Participants
2626305|NCT01901874|Secondary|30-Day MAE - Myocardial Infarction|Any myocardial infarction through 30 days post-index procedure|30 days|Per protocol subjects with 30-day MAE evaluation|||Participants|||Count of Participants
2626306|NCT01901874|Secondary|30-Day MAE - Death|Any cause death through 30 days post-index procedure|30 days|Per protocol subjects with 30-day MAE evaluation|||Participants|||Count of Participants
2626307|NCT01901874|Secondary|Number of Participants Who Experienced MAE at 30 Days|Defined as any death, stroke, or myocardial infarction through 30 days post-index procedure.|30 days|Per protocol subjects with 30-day MAE evaluation|||Participants|||Count of Participants
2626308|NCT01901874|Secondary|Number of Participants Who Achieved Procedure Success|Procedure Success defined as Stent Technical Success with < 30% residual stenosis and no in-hospital MAE.|Procedural|Per protocol subjects|||Participants|||Count of Participants
2626309|NCT01901874|Secondary|Number of Participants Who Achieved Embolic Protection Device (EPD) Technical Success|EPD Technical Success defined as GORE® Embolic Filter delivered, placed, and retrieved without requiring assisting interventional methods.|Procedural|Per protocol subjects|||Participants|||Count of Participants
2626310|NCT01901874|Secondary|Number of Participants Who Achieved Stent Technical Success|Stent Technical Success defined as successful implantation of a GORE® Carotid Stent|Procedural|Per protocol subjects|||Participants|||Count of Participants
2626311|NCT01901874|Primary|Number of Participants Who Experienced Major Adverse Events (MAE) at One Year|MAE defined as any death, stroke, or myocardial infarction through 30 days post-index procedure, or ipsilateral stroke between 31 days and 1 year (365 days).|365 days|Per protocol subjects with 1-year MAE evaluation|||Participants|||Count of Participants
2626312|NCT01901848|Primary|Number of Participants Who Self-reported 7-day Point Prevalence Smoking Abstinence as Bioverified by Breath Carbon Monoxide < 4 Parts Per Million.|Self-reported 7-day point prevalence smoking abstinence was bioverified by breath carbon monoxide level of < 4 parts per million at the 6-month follow-up.|6-month follow-up||||Participants|||Count of Participants
2626313|NCT01901848|Primary|Number of Participants Who Self-report 7-day Point Prevalence Smoking Abstinence at 6-month Follow-up.|7-day point prevalence abstinence is defined as participant reporting no smoking occasions in the 7 days preceding the 6-month follow-up appointment. The 6-month follow-up occurs 6 months after the initial scheduled quit date.|6-month follow-up||||Participants|||Count of Participants
2626314|NCT01901809|Primary|Percent Change in Serum Creatinine at 72 Hours - Dopamine vs No Dopamine|Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation by dopamine strategy|72 hours||||percent change in serum creatinine||95% Confidence Interval|Mean
2626315|NCT01901809|Primary|Percent Change in Serum Creatinine at 72 Hours - Continuous vs Intermittent Diuretic|Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation by diuretic strategy|72 hours||||percent change in serum creatinine||95% Confidence Interval|Mean
2626316|NCT01901809|Primary|Percent Change in Serum Creatinine at 72 Hours.|Percent change in serum creatinine from randomization to 72 hrs from treatment protocol initiation.|72 hours||||percent change in serum creatinine||Standard Deviation|Mean
2626317|NCT01901653|Secondary|Area Under the Serum Concentration-time Curve (AUC) of Rovalpituzumab Tesirine ADC|The area under the serum concentration-time curve (AUC; measured in μg•d/mL) is a method of measurement to determine the total exposure of a drug in blood serum.|From Day 1 of first dose to End of Dose Cycle|All subjects who received at least 1 dose of study drug, with evaluable data at each given timepoint. For Phase 1b, pharmacokinetic (PK) sampling was sparse; therefore, pharmacokinetic parameters were not estimated.|||μg•d/mL||Geometric Coefficient of Variation|Geometric Mean
2626318|NCT01901653|Secondary|Maximum Serum Concentration (Cmax) of Rovalpituzumab Tesirine Antibody Drug Conjugate (ADC)|The maximum serum concentration (Cmax; measured in μg/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing cycle.|From Day 1 of first dose to End of Dose Cycle|All subjects who received at least 1 dose of study drug, with evaluable data at each given timepoint. For Phase 1b, pharmacokinetic (PK) sampling was sparse; therefore, pharmacokinetic parameters were not estimated.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2626429|NCT01900652|Secondary|Duration of Response (DoR)|Zero participants analyzed. Duration of Response for CR and PR data was not collected for analysis due to N=0 CR and N=3 PR.|Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)|Zero participants analyzed. Duration of Response for CR and PR data was not collected for analysis due to N=0 CR and N=3 PR.||||||
2626320|NCT01901653|Secondary|Progression-free Survival (PFS)|"Progression-free survival (PFS) was defined as the number of months from the first day of study drug administration to disease recurrence or progression, or death on study.~Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC)."|From first dose of rovalpituzumab tesirine to last event timepoint, up through study completion (approximately 4 months on average, but up to 14.46 months).|Subjects with at least one post-dose assessment.|||months||95% Confidence Interval|Median
2626321|NCT01901653|Secondary|Clinical Benefit Rate (CBR)|"Clinical Benefit is defined as a subject with best Overall Response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) prior to receiving any subsequent anticancer therapy; as defined by RECIST version 1.1. CBR is defined as the proportion of subjects with Clinical Benefit based on assessment of overall response. CBR will be presented as a number and percentage with 95% confidence bounds. Any subjects not exhibiting a response (CR or PR or SD) are considered non-responders.~Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC)."|From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on avergae approximately 4 months).|Subjects with at least one post-dose assessment.|||percentage of subjects||95% Confidence Interval|Number
2626322|NCT01901653|Secondary|Duration of Response (DOR)|"Duration of response (DOR) was defined as the number of months from the initial CR or PR to the time of disease progression or death, whichever occurred first.~Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC)."|From first dose of Rovalpituzumab tesirine to last event timepoint, up through study completion (on average approximately 4 months, but up to 6.51 months).|Subjects with at least one post-dose assessment. No LCNEC subjects achieved CR or PR, therefore DOR was not analyzed.|||months||95% Confidence Interval|Median
2626323|NCT01901653|Secondary|Objective Response Rate (ORR)|"Overall response was assessed at each visit post-baseline based on a subject's lesion measurements or assessments (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], or not evaluable as defined by RECIST v1.1, plus an additional category of early death). The best overall response was then determined. A subject was defined as having an objective response if they had a best overall response of CR or PR prior to receiving any subsequent anticancer therapy; confirmed response is confirmation of CR or PR at least 4 weeks from the initial determination per RECIST v1.1. Subjects with a post-baseline assessment were included in the calculations for objective response rate (ORR).~Outcome is based on data reported by Investigator (INV); available and evaluable radiographic scans were collected retrospectively for review by an Independent Review Committee (IRC)."|From first dose of rovalpituzumab tesirine to last event, up through study completion (on average approximately 4 months).|Subjects with at least one post-dose assessment. All LCNEC subjects were analyzed. No LCNEC subjects achieved CR or PR and, therefore, the ORR was 0%.|||percentage of subjects||95% Confidence Interval|Number
2626324|NCT01901653|Primary|Maximum Tolerated Dose (MTD) of Rovalpituzumab Tesirine|MTD was determined by testing increasing doses from 0.05 mg/kg up to 0.8 mg/kg on Day 1 of every 21-day or 42-day cycle, Phase 1a cohorts 1 to 8. MTD will be defined as the dose level immediately below the dose level at which ≥ 2 of the first 3 subjects per cohort (or ≥ 2 of 6 subjects) during the first cycle experience a study drug related dose limiting toxicity (DLT).|The DLT period was defined as either 21 or 42 days following the first dose of Rovalpituzumab tesirine during dose escalation (Phase 1a), depending on Cycle length.|All subjects from Phase 1a Dose Escalation: Cohort 1 to 8 who received at least 1 dose of study drug.|||mg/kg|||Number
2626325|NCT01901614|Primary|Does LALAK Achieve the Same Level of Post-operative BSCVA as IEK.|The primary goal of the trial is to determine if LALAK can achieve the same level of postoperative Best Spectacle Corrected Visual Acuity (BSCVA) guided by OCT as IEK. The BSCVA will be measured using a clinic Snellen chart and recorded in the typical Snellen fraction (20/xx) in feet. This will be converted to logMAR form for statistical analysis.|24 months|For the LALAK group, there were 3 subjects enrolled, but one was a screen fail so no data was obtained for that subject.|||logMAR unit||95% Confidence Interval|Mean
2626326|NCT01901588|Secondary|Time to PACU Discharge||Length of PACU stay (around 3 hours on average)||||minutes||Standard Deviation|Mean
2626327|NCT01901588|Secondary|Time to Arousal||Length of PACU stay (around 3 hours on average)||||minutes||Standard Deviation|Mean
2626328|NCT01901588|Secondary|Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications||Length of PACU stay (around 3 hours on average)||||percentage of participants|||Number
2626329|NCT01901588|Secondary|Post-op Pain Interventions||Length of PACU stay (around 3 hours on average)||||number of pain interventions/group|||Number
2626330|NCT01901588|Secondary|Percentage of Participants Receiving Pain Medication||Length of PACU stay (around 3 hours on average)||||percentage of participants|||Number
2626331|NCT01901588|Primary|Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery||Length of PACU stay (around 3 hours on average)||||percentage of participants|||Number
2626332|NCT01901575|Primary|PVC Suppression With Remifentanil Sedation|1 observed suppression of PVC's (PVC's of the same morphology are no longer observed during any 15 minute recording interval) 0 no suppression|duration of the operative procedure, average 2 hours||||participants with PVC suppression|||Number
2626333|NCT01901575|Primary|Inhibition of Idiopathic Ventricular Tachycardia|"observation of the anesthetic effect on the inhibition of the ventricular tachycardia in patients undergoing radio-frequency ablation of idiopathic ventricular tachycardia. Patients were continuously monitored for presence of PVC's.~Every 15 minutes patient's heart rhythm (EKG) was documented on the anesthetic record. Presence of PVC's of the same morphology was confirmed by the cardiologist performing the ablation."|duration of the procedure or until the presence of PVC's was no longer required for the cardiologist to complete the ablation, average 2 hours|Study Data impacted by Storm Sandy in NYC and data lost for reporting||||||
2626443|NCT01900561|Secondary|Brief Cope - 6 Items|We assessed participants' coping during the five- and 12-month follow-up assessments using six items from the 28-item Brief Cope instrument. This instrument measures emotion-focused, problem-focused, and dysfunctional coping and has been used in cancer survivors. Scores range from 1 to 5 with higher scores indicating better coping skills.|12 months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626334|NCT01901432|Secondary|Assessment of AUC0-12 of Givinostat and Metabolites (ITF2374 and ITF2375) in Part B of the Study|"PK evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of AUC0-12 following administration of givinostat for 2 cycles in Part B. PK calculations were performed by standard non-compartmental analysis and AUClast was calculated using the linear trapezoidal rule. Following definition of the MTD in Part A, during Part B Cycle 1, givinostat was administered at 100 mg b.i.d. and during Part B Cycle 2 was administered at 100 mg, 75 mg and 50 mg b.i.d. (since dose reductions due to TEAEs were allowed from Cycle 2 onwards, as per protocol). Results are reported for Cycle 1 Day 1 and Cycle 2 Day 28 for the doses administered during Part B.~Note: PK evaluation for the givinostat 75 mg and 50 mg b.i.d. dose groups for Cycle 1 Day 1 was not applicable (since all received givinostat 100 mg b.i.d.). Additionally, concentration data for ITF2374 (Cycle 1 Day 28) across all dose groups and for ITF2375 in the 50 mg b.i.d. dose group was not available for PK analysis."|Blood samples were collected in Part B on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 2 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose.|The PK analysis set included all SAF patients with at least 1 PK assessment. Only patients with data available for analysis at each time point are presented.|||ng*h/mL||Standard Deviation|Mean
2626335|NCT01901432|Secondary|Assessment of AUClast of Givinostat and Metabolites (ITF2374 and ITF2375) in Part B of the Study|"PK evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of AUClast following administration of givinostat for 2 cycles in Part B. PK calculations were performed by standard non-compartmental analysis and AUClast was calculated using the linear trapezoidal rule. Following definition of the MTD in Part A, during Part B Cycle 1, givinostat was administered at 100 mg b.i.d. and during Part B Cycle 2 was administered at 100 mg, 75 mg and 50 mg b.i.d. (since dose reductions due to TEAEs were allowed from Cycle 2 onwards, as per protocol). Results are reported for Cycle 1 Day 1 and Cycle 2 Day 28 for the for the doses administered during Part B.~Note: PK evaluation for the givinostat 75 mg and 50 mg b.i.d. dose groups for Cycle 1 Day 1 was not applicable (since all received givinostat 100 mg b.i.d.). Additionally, concentration data for ITF2375 (Cycle 1 Day 28) in the 50 mg b.i.d. dose group was not available for PK analysis."|Blood samples were collected in Part B on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 2 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose.|The PK analysis set included all SAF patients with at least 1 PK assessment. Only patients with data available for analysis at each time point are presented.|||ng*h/mL||Standard Deviation|Mean
2626336|NCT01901432|Secondary|Assessment of Tlast of Givinostat and Metabolites (ITF2374 and ITF2375) in Part B of the Study|"PK evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of Tlast following administration of givinostat for 2 cycles in Part B. PK calculations were performed by standard non-compartmental analysis. Following definition of the MTD in Part A, during Part B Cycle 1, givinostat was administered at 100 mg b.i.d. and during Part B Cycle 2 was administered at 100 mg, 75 mg and 50 mg b.i.d. (since dose reductions due to TEAEs were allowed from Cycle 2 onwards, as per protocol). Results are reported for Cycle 1 Day 1 and Cycle 2 Day 28 for the doses administered during Part B.~Note: PK evaluation for the givinostat 75 mg and 50 mg b.i.d. dose groups for Cycle 1 Day 1 was not applicable (since all received givinostat 100 mg b.i.d.). Additionally, concentration data for ITF2375 (Cycle 1 Day 28) in the 50 mg b.i.d. dose group was not available for PK analysis."|Blood samples were collected in Part B on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 2 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose.|The PK analysis set included all SAF patients with at least 1 PK assessment. Only patients with data available for analysis at each time point are presented.|||hours||Standard Deviation|Mean
2626337|NCT01901432|Secondary|Assessment of Tmax of Givinostat and Metabolites (ITF2374 and ITF2375) in Part B of the Study|"PK evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of Tmax following administration of givinostat for 2 cycles in Part B. PK calculations were performed by standard non-compartmental analysis. Following definition of the MTD in Part A, during Part B Cycle 1, givinostat was administered at 100 mg b.i.d. and during Part B Cycle 2 was administered at 100 mg, 75 mg and 50 mg b.i.d. (since dose reductions due to TEAEs were allowed from Cycle 2 onwards, as per protocol). Results are reported for Cycle 1 Day 1 and Cycle 2 Day 28 for the doses administered during Part B.~Note: PK evaluation for the givinostat 75 mg and 50 mg b.i.d. dose groups for Cycle 1 Day 1 was not applicable (since all received givinostat 100 mg b.i.d.). Additionally, concentration data for ITF2375 (Cycle 1 Day 28) in the 50 mg b.i.d. dose group was not available for PK analysis."|Blood samples were collected in Part B on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 2 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose.|The PK analysis set included all SAF patients with at least 1 PK assessment. Only patients with data available for analysis at each time point are presented.|||hours||Full Range|Median
2626338|NCT01901432|Secondary|Assessment of Cmax of Givinostat and Metabolites (ITF2374 and ITF2375) in Part B of the Study|"PK evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of Cmax following administration of givinostat for 2 cycles in Part B. PK calculations were performed by standard non-compartmental analysis. Following definition of the MTD in Part A, during Part B Cycle 1, givinostat was administered at 100 mg b.i.d. and during Part B Cycle 2 was administered at 100 mg, 75 mg and 50 mg b.i.d. (since dose reductions due to TEAEs were allowed from Cycle 2 onwards, as per protocol). Results are reported for Cycle 1 Day 1 and Cycle 2 Day 28 for the doses administered during Part B.~Note: PK evaluation for the givinostat 75 mg and 50 mg b.i.d. dose groups for Cycle 1 Day 1 was not applicable (since all received givinostat 100 mg b.i.d.). Additionally, concentration data for ITF2375 (Cycle 1 Day 28) in the 50 mg b.i.d. dose group was not available for PK analysis."|Blood samples were collected in Part B on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 2 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose.|The PK analysis set included all SAF patients with at least 1 PK assessment. Only patients with data available for analysis at each time point are presented.|||ng/mL||Standard Deviation|Mean
2626367|NCT01901302|Secondary|Change From Baseline of Chronic Opioid-Related Gastrointestinal Symptom Scale (CORGISS) Scores at 12 Weeks|"The CORGISS is designed to assess GI symptoms related to opioid use in patients with chronic non-cancer pain. The CORGISS asks participants to rate the severity of GI symptoms over the previous 24 hours, with answers ranging from 0 (did not experience) to 4 (very severe)."|Baseline, 12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.||||||
2626339|NCT01901432|Secondary|Assessment of Area Under Plasma Concentration Versus the Time Curve in the Dosing Interval (0-12 Hours) (AUC0-12) of Givinostat and Metabolites (ITF2374 and ITF2375) in Part A of the Study|"PK evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of AUC0-12 following administration of givinostat for 1 cycle in Part A. PK calculations were performed by standard non-compartmental analysis and AUC0-12 was calculated using the linear trapezoidal rule. Results are reported for Cycle 1 Day 1 and Cycle 1 Day 28.~Note:concentration data for ITF2374 (Cycle 1 Day 1 and Cycle 1 Day 28) across all dose groups and for ITF2375 (Cycle 1 Day 1) in the DL0 dose group of Part A were not available for PK analysis."|Blood samples were collected in Part A on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 1 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose.|The PK analysis set included all SAF patients with at least 1 PK assessment. Only patients with data available for analysis at each time point are presented.|||ng*h/mL||Standard Deviation|Mean
2626340|NCT01901432|Secondary|Assessment of Area Under Plasma Concentration Versus the Time Curve up to the Last Detectable Concentration (AUClast) of Givinostat and Metabolites (ITF2374 and ITF2375) in Part A of the Study|"PK evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of AUClast following administration of givinostat for 1 cycle in Part A. PK calculations were performed by standard non-compartmental analysis and AUClast was calculated using the linear trapezoidal rule. Results are reported for Cycle 1 Day 1 and Cycle 1 Day 28.~Note: concentration data for ITF2374 (Cycle 1 Day 1 and Cycle 1 Day 28) and for ITF2375 (Cycle 1 Day 1) in the DL0 dose group of Part A were not available for PK analysis."|Blood samples were collected in Part A on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 1 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose.|The PK analysis set included all SAF patients with at least 1 PK assessment. Only patients with data available for analysis at each time point are presented.|||ng*h/mL||Standard Deviation|Mean
2626341|NCT01901432|Secondary|Assessment of Time of the Last Detectable Concentration (Tlast) of Givinostat and Metabolites (ITF2374 and ITF2375) in Part A of the Study|"PK evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of Tlast following administration of givinostat for 1 cycle in Part A. PK calculations were performed by standard non-compartmental analysis. Results are reported for Cycle 1 Day 1 and Cycle 1 Day 28.~Note: concentration data for ITF2374 (Cycle 1 Day 1 and Cycle 1 Day 28) and for ITF2375 (Cycle 1 Day 1) in the DL0 dose group of Part A were not available for PK analysis."|Blood samples were collected in Part A on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 1 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose.|The PK analysis set included all SAF patients with at least 1 PK assessment. Only patients with data available for analysis at each time point are presented.|||hours||Standard Deviation|Mean
2626342|NCT01901432|Secondary|Assessment of Time to Maximum Plasma Concentration (Tmax) of Givinostat and Metabolites (ITF2374 and ITF2375) in Part A of the Study|"PK evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of Tmax following administration of givinostat for 1 cycle in Part A. PK calculations were performed by standard non-compartmental analysis. Results are reported for Cycle 1 Day 1 and Cycle 1 Day 28.~Note: concentration data for ITF2374 (Cycle 1 Day 1 and Cycle 1 Day 28) and for ITF2375 (Cycle 1 Day 1) in the DL0 dose group of Part A were not available for PK analysis."|Blood samples were collected in Part A on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 1 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose.|The PK analysis set included all SAF patients with at least 1 PK assessment. Only patients with data available for analysis at each time point are presented.|||hours||Full Range|Median
2626343|NCT01901432|Secondary|Assessment of Maximum Plasma Concentration (Cmax) of Givinostat and Metabolites (ITF2374 and ITF2375) in Part A of the Study|"Pharmacokinetic (PK) evaluation of givinostat and metabolites (ITF2374 and ITF2375) by assessment of Cmax following administration of givinostat for 1 cycle in Part A. PK calculations were performed by standard non-compartmental analysis. Results are reported for Cycle 1 Day 1 and Cycle 1 Day 28.~Note: concentration data for ITF2374 (Cycle 1 Day 1 and Cycle 1 Day 28) and for ITF2375 (Cycle 1 Day 1) in the DL0 dose group of Part A were not available for PK analysis."|Blood samples were collected in Part A on Cycle 1 Day 1: pre-dose and 2, 3 and 8 hours post-dose; and on Cycle 1 Day 28: pre-dose and 1, 2, 4 and 8 hours post-dose.|The PK analysis set included all SAF patients with at least 1 PK assessment. Only patients with data available for analysis at each time point are presented.|||nanograms per millilitre (ng/mL)||Standard Deviation|Mean
2626344|NCT01901432|Secondary|Number of Patients Experiencing TEAEs After 6 Cycles in Part B of the Study|Evaluations were performed on the type, incidence and severity of TEAEs, graded according to CTCAE v. 4.03, following administration of givinostat at the MTD for up to 6 cycles of treatment in Part B. Grades 1 through 5 were as follows: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening or requiring hospitalisation; Grade 4: Life threatening consequences; Grade 5: Death related to AE. Results are reported as number of patients with TEAEs for each of the indicated categories. Definitions: drug-related TEAE / TESAE corresponded to reasonable suspicion that the TEAE / TESAE was associated with the use of the study drug, according to investigator assessment; discontinuation refers to discontinuation from treatment. Results are reported as number of patients with TEAEs for each of the indicated categories.|168 days (up to Cycle 6 Day 28 in Part B).|The SAF analysis set included all recruited patients who received ≥1 dose of study drug.|||participants|||Number
2626345|NCT01901432|Secondary|ORR After 6 Cycles in Part B of the Study|ORR following administration of givinostat at the MTD for 6 cycles in Part B, reported as percentage of patients with a response. Response was evaluated according to the clinico-hematological ELN response criteria. If Investigator's clinical response assessment (taking into account the overall medical judgment of the specific patient's case) was not in agreement with exact application of the ELN response criteria, the Investigator's assessment superseded the mathematical application of these criteria and was used for analysis.|168 days (up to Cycle 6 Day 28 in Part B).|The ITT analysis set included all recruited patients who received ≥1 dose of study drug and from whom ≥1 post-baseline efficacy measurement was obtained.|||percentage of participants||95% Confidence Interval|Number
2626444|NCT01900561|Secondary|Brief Cope - 6 Items|We assessed participants' coping during the five- and 12-month follow-up assessments using six items from the 28-item Brief Cope instrument. This instrument measures emotion-focused, problem-focused, and dysfunctional coping and has been used in cancer survivors. Scores range from 1 to 5 with higher scores indicating better coping skills.|5 months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626346|NCT01901432|Secondary|ORR After 3 Cycles and After 6 Cycles in Part A of the Study|ORR following administration of givinostat after 3 cycles and after 6 cycles in Part A, reported as percentage of patients with a response. Response was evaluated according to the clinico-hematological ELN response criteria. If Investigator's clinical response assessment (taking into account the overall medical judgment of the specific patient's case) was not in agreement with exact application of the ELN response criteria, the Investigator's assessment superseded the mathematical application of these criteria and was used for analysis. Analysis performed using the dataset for all Part A patients combined.|84 and 168 days (up to Cycle 3 Day 28 and Cycle 6 Day 28 in Part A).|The ITT analysis set included all recruited patients who received ≥1 dose of study drug and from whom ≥1 post-baseline efficacy measurement was obtained.|||percentage of participants||95% Confidence Interval|Number
2626347|NCT01901432|Primary|Overall Response Rate (ORR) (i.e. Complete Response [CR] and Partial Response [PR]) After 3 Cycles in Part B of the Study|"ORR, CR and PR following administration of givinostat at MTD for 3 cycles in Part B, reported as percentage of patients with a response. Response was evaluated according to the clinico-hematological European LeukemiaNet (ELN) response criteria. If Investigator's clinical response assessment (taking into account the overall medical judgment of the specific patient's case) was not in agreement with exact application of the ELN response criteria, the Investigator's assessment superseded the mathematical application of these criteria and was used for analysis.~CR defined as:~Hematocrit (HCT) <45% without phlebotomy, and~Platelets ≤400 x10^9/litre (L), and~White Blood Cell count ≤10 x10^9/L, and~Normal spleen size, and~No disease-related systemic symptoms (i.e. pruritus, headache, microvascular disturbances).~PR defined as: Patients not fulfilling CR and~HCT <45% without phlebotomy, or~Response in ≥3 other criteria."|84 days (up to cycle 3 Day 28 in Part B).|The Intent-to-Treat (ITT) analysis set included all recruited patients who received ≥1 dose of study drug and from whom ≥1 post-baseline efficacy measurement was obtained.|||percentage of participants||95% Confidence Interval|Number
2626348|NCT01901432|Primary|Number of Patients Experiencing TEAEs After 3 Cycles in Part B of the Study|Evaluations were performed on the type, incidence and severity of TEAEs, graded according to CTCAE v. 4.03, following administration of givinostat at the MTD for up to 3 cycles of treatment in Part B. Grades 1 through 5 were as follows: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening or requiring hospitalisation; Grade 4: Life threatening consequences; Grade 5: Death related to AE. Results are reported as number of patients with TEAEs for each of the indicated categories. Definitions: drug-related TEAE / TESAE corresponded to reasonable suspicion that the TEAE / TESAE was associated with the use of the study drug, according to investigator assessment; discontinuation refers to discontinuation from treatment.|84 days (up to Cycle 3 Day 28 in Part B).|The SAF analysis set included all recruited patients who received ≥1 dose of study drug.|||Participants|||Count of Participants
2626349|NCT01901432|Primary|Number of Dose Limiting Toxicities (DLTs) After 1 Cycle in Part A of the Study|"The MTD of givinostat was based only on Cycle 1 DLTs. A DLT was defined as the following drug-related toxicity:~Grade 4 hematological toxicity, or~Grade 3 febrile neutropenia, or~Grade ≥3 non-hematological toxicity (with the exception Grade 3 diarrhea without adequate supportive care lasting less than 3 days, and Grade 3 nausea or vomiting without adequate supportive care lasting less than 3 days), or~Any drug-related serious AE, or~Any toxicity clearly not related to disease progression or intercurrent illness requiring interruption of dosing for more than 3 days during first cycle.~At end of Cycle 1, for the third patient in each DL, the safety of the 3 patients treated for 1 cycle was reviewed and it was decided if the dose should be escalated or not. Results are reported as the number of patients with DLT events for Cycle 1 in Part A."|28 days (up to Cycle 1 Day 28 in Part A).|The MTD analysis set included all patients who experienced a DLT in Cycle 1 of Part A, or received ≥90% of study drug doses in Cycle 1 of Part A.|||participants|||Number
2626350|NCT01901432|Primary|Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) in Part A of the Study|Evaluations were performed on the type, incidence and severity of TEAEs, graded according to Common Terminology Criteria for Adverse Events (CTCAE) v. 4.03, following administration of givinostat for up to 6 cycles of treatment in Part A. Grades 1 through 5 were as follows: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening or requiring hospitalisation; Grade 4: Life threatening consequences; Grade 5: Death related to AE. Results are reported as number of patients with TEAEs for each of the indicated categories. Definitions: drug-related TEAE / treatment-emergent serious adverse event (TESAE) corresponded to reasonable suspicion that the TEAE / TESAE was associated with the use of the study drug, according to investigator assessment; discontinuation refers to discontinuation from treatment.|168 days (up to Cycle 6 Day 28 in Part A).|The Safety (SAF) analysis set included all recruited patients who received ≥1 dose of study drug.|||Participants|||Count of Participants
2626351|NCT01901393|Primary|Efficacy of Pain Relief (Pain Intensity With Movement)|"Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain)."|First possible time post-surgery, an expected average of 6 hours|This analysis was performed on all subject who completed the VAS with Movement Immediately Following their Procedure|||units on a scale (in mm)||Standard Deviation|Mean
2626352|NCT01901393|Secondary|Incidence of Serious Adverse Events|Number of subjects experiencing treatment-emergent serious adverse events|Post-operative period until discharge, an expected average of 6 hours||||Number of events|||Number
2626353|NCT01901393|Secondary|Patient Satisfaction|Measured using 2 question, 4 point scale.|Post-operative period until discharge, an expected average of 6 hours||||Participants|||Number
2626354|NCT01901393|Secondary|Time to First Use of Rescue Med Will be Measured|Time to first rescue medication (in hours) in the postoperative period through discharge.|Post-operative period until discharge, an expected average of 6 hours||||hours||Standard Error|Mean
2626355|NCT01901393|Secondary|Rescue Medication Use in Post-operative Period|Amount of rescue medication (in milligrams) will be measured|Post-operative period until discharge, an expected average of 6 hours||||milligrams||Standard Deviation|Mean
2626356|NCT01901393|Primary|Efficacy of Pain Relief (Pain Intensity at Rest)|"Pain assessed using VAS (Visual Analog Scale, VAS). The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 (No Pain) and 100 (Worst Possible Pain)."|First possible time post-surgery, an expected average of 6 hours|This analysis was performed on all subject who completed the VAS at Rest Immediately Following their Procedure|||units on a scale (in mm)||Standard Deviation|Mean
2626357|NCT01901341|Other Pre-specified|Cardiovascular, Gastrointestinal and Central Opioid Withdrawal Events|"Cardiovascular (CV) events of interested included myocardial infarction, unstable angina, cardiovascular accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death.~Gastrointestinal (GI) events of interest included emergency department visits for SAEs of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping.~Central opioid withdrawal events of interest included opioid withdrawal syndrome."|Baseline through 16 weeks|All participants randomized to treatment who received ≥ 1 dose of double-blind study medication.|||participants|||Number
2626358|NCT01901341|Secondary|Overall Complete Spontaneous Bowel Movement (CSBM) Responder Rates at 12 Weeks|A CSBM Weekly Responder is a subject who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week. An Overall CSBM Responder is a subject who is a Weekly CSBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.||||||
2626359|NCT01901341|Secondary|Change From Baseline of Chronic Opioid-Related Gastrointestinal Symptom Scale (CORGISS) Scores at 12 Weeks|"The CORGISS is designed to assess GI symptoms related to opioid use in patients with chronic non-cancer pain. The CORGISS asks participants to rate the severity of GI symptoms over the previous 24 hours, with answers ranging from 0 (did not experience) to 4 (very severe)."|Baseline, 12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.||||||
2626360|NCT01901341|Primary|Overall Spontaneous Bowel Movement (SBM) Responder Rates at the 12-weeks|A Spontaneous Bowel Movement (SBM) Weekly Responder (calculated for each week of the 12-week double-blind treatment period) is a participant who has ≥ 3 SBMs for the week and an increase from baseline of ≥1 SBM for the specified week, based on at least 4 Available Data Days (ADDs) during the week. For the definition of the primary efficacy endpoint, Overall SBM Responder is a participant who is a Weekly SBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.||||||
2626361|NCT01901328|Other Pre-specified|Adjudicated Cardiovascular, Gastrointestinal and Central Opioid Withdrawal Events|"Cardiovascular (CV) events of interested included myocardial infarction, unstable angina, cardiovascular accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death.~Gastrointestinal (GI) events of interest included emergency department visits for SAEs of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping.~Central opioid withdrawal events of interest included opioid withdrawal syndrome."|Baseline through 16 weeks||||participants|||Number
2626362|NCT01901328|Secondary|Overall Complete Spontaneous Bowel Movement (CSBM) Responder Rates at 12 Weeks|A CSBM Weekly Responder is a subject who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week. An Overall CSBM Responder is a subject who is a Weekly CSBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.||||||
2626363|NCT01901328|Secondary|Change From Baseline of Chronic Opioid-Related Gastrointestinal Symptom Scale (CORGISS) Scores at 12 Weeks|"The CORGISS is designed to assess GI symptoms related to opioid use in patients with chronic non-cancer pain. The CORGISS asks participants to rate the severity of GI symptoms over the previous 24 hours, with answers ranging from 0 (did not experience) to 4 (very severe)."|Baseline, 12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.||||||
2626364|NCT01901328|Primary|Overall Spontaneous Bowel Movement (SBM) Responder Rates at 12-weeks|A Spontaneous Bowel Movement (SBM) Weekly Responder (calculated for each week of the 12-week double-blind treatment period) is a participant who has ≥ 3 SBMs for the week and an increase from baseline of ≥1 SBM for the specified week, based on at least 4 Available Data Days (ADDs) during the week. For the definition of the primary efficacy endpoint, Overall SBM Responder is a participant who is a Weekly SBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.||||||
2626365|NCT01901302|Other Pre-specified|Adjudicated Cardiovascular, Gastrointestinal and Central Opioid Withdrawal Events|"Cardiovascular (CV) events of interested included mycardial infarction, unstable angina, cardiovascular accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death.~Gastrointestinal (GI) events of interest included emergency department visits for SAEs of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping.~Central opioid withdrawal events of interest included opioid withdrawal syndrome."|Baseline through 16 weeks|All participants randomized to treatment who received ≥ 1 dose of double-blind study medication.|||participants|||Number
2626366|NCT01901302|Secondary|Overall Complete Spontaneous Bowel Movement (CSBM) Responder Rates at 12 Weeks|A CSBM Weekly Responder is a participant who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week. An Overall CSBM Responder is a subject who is a Weekly CSBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.||||||
2626368|NCT01901302|Primary|Overall Spontaneous Bowel Movement (SBM) Responder Rates at 12 Weeks|"A Spontaneous Bowel Movement (SBM) Weekly Responder (calculated for each week of the 12-week double-blind treatment period) is a participant who has ≥ 3 SBMs for the week and an increase from baseline of ≥1 SBM for the specified week, based on at least 4 Available Data Days (ADDs) during the week. A Complete SBM (CSBM) Weekly Responder is a participant who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week.~For the definition of the primary efficacy endpoint, Overall SBM Responder is a participant who is a Weekly SBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12)."|12 weeks|Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early.||||||
2626369|NCT01901289|Primary|Number of Lesions Without Target Lesion Revascularization (TLR)|A reintervention performed for ≥ 50 % diameter stenosis within ± 5 mm proximal and /or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral arterial disease (PAD) following the initial procedure.|1 year|All lesions with information through 12-months. The result was calculated using the Kaplan-Meier method (with Greenwood's formula for standard error).|||Lesions|Lesions||Count of Units
2626370|NCT01901250|Primary|Change in the Number of Decayed or Filled Permanent Teeth (DFT) From Baseline (Beginning of Kindergarten) to the Middle of 2nd Grade|"The primary outcome measure was change in the number of decayed or filled permanent teeth (DFT). Caries was assessed in accordance to the International Caries Detection and Assessment System (ICDAS). The ICDAS criteria record both the severity and activity of the lesion on occlusal surfaces, in pit and fissure sites on the buccal and lingual surfaces, and on other smooth surfaces.~For the purposes of this study, an ICDAS severity score of 3 to 6 and the presence of fillings constituted the D and F portions of DFT, respectively."|baseline and middle of 2nd grade||||Number of surfaces||Standard Deviation|Mean
2626371|NCT01901224|Other Pre-specified|Change in Six Minute Walk Test|The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.The 6 MWT is measured in meters, and higher values indicate better outcomes.|baseline, 12 weeks|Study was not funded and was terminated prematurely. Randomization blind was never broken, and data was not collected on the outcome measures.||||||
2626372|NCT01901224|Other Pre-specified|Change in Oxygen Consumption|Oxygen consumption is measured in ml/kg/min. Higher values indicate better outcomes.|baseline, 12 weeks|Study was not funded and was terminated prematurely. Randomization blind was never broken, and data was not collected on the outcome measures.||||||
2626373|NCT01901224|Other Pre-specified|Change in Pain-free Treadmill Walking Time|Pain-free treadmill walking time is measured in minutes or seconds. Higher values indicate a better outcome.|baseline, 12 weeks|Study was not funded and was terminated prematurely. Randomization blind was never broken, and data was not collected on the outcome measures.||||||
2626374|NCT01901224|Other Pre-specified|Change in Maximal Treadmill Walking Time|Maximal treadmill walking time is measured in minutes or seconds. Higher values indicate a better outcome.|baseline, 12 weeks|Study was not funded and was terminated prematurely. Randomization blind was never broken, and data was not collected on the outcome measures.||||||
2626375|NCT01901224|Secondary|Change in Flow-mediated Dilation (FMD)|Flow mediated vasodilation of the brachial artery is a measure of endothelium-dependent vasodilation. Higher flow-mediated dilation (FMD), measured as the diameter of the brachial artery in millimeters, and reported as percent change after a flow stimulus compered to basal measurement, is better, indicative of better endothelial function.|baseline, 12 weeks|Study was not funded and was terminated prematurely. Randomization blind was never broken, and data was not collected on the outcome measures.||||||
2626376|NCT01901224|Primary|Change in PCr Recovery Time|PCr recovery time, measured in seconds, is a measure of skeletal muscle metabolic function. PCr is a transport molecule and reservoir of high-energy phosphate bonds, which is important for cellular energetics. Phosphocreatine regeneration depends upon the skeletal muscle mitochondrial cells capacity for oxidative phosphorylation. We will measure PCr recovery time at baseline and after 12 weeks of treatment with metformin or placebo as an in vivo measure of mitochondrial function. Higher Pcr relative to P(i) during recovery is better and shorter recovery times are better.|baseline, 12 weeks|Study was not funded and was terminated prematurely. Randomization blind was never broken, and data was not collected on the outcome measures.||||||
2626377|NCT01901211|Secondary|Anthropometric Measurements (Weight)|Anthropometric measurements of waist circumference, triceps and subscapular skinfold thickness, and weight will be used to assess body composition as indicators of physical fitness.|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)|One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.|||Kg||Standard Deviation|Mean
2626378|NCT01901211|Secondary|StepWatch Activity Monitors|StepWatch Activity Monitors will be used to measure activity levels and motor participation. The StepWatch is a two-plane accelerometer that is worn around the ankle in a knit cuff. The StepWatch measures ambulatory activity (i.e. total daily step count) and acts as an indicator of motor participation in the community.|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)||||Steps/day||Standard Deviation|Mean
2626379|NCT01901211|Secondary|Gaming Data|"Gaming data will be collected as measures of effectiveness of the games' balancing techniques, engagement and adherence. The games will be instrumented to automatically collect usage data including: amount of time playing; amount of time within HR zones while playing.~Higher numbers indicate more activity and more time above 40% hear rate reserve (HRR) while playing."|10-weeks of the exergaming intervention||||minutes||Standard Deviation|Mean
2626445|NCT01900561|Secondary|Perceived Efficacy in Patient-Physician Interactions (PEPPI) - 5-item Short Form|Self-efficacy in patient-physician interactions was assessed at 5 and 12 months using a five-item short form version of the Perceived Efficacy in Patient-Physician Interactions (PEPPI). The PEPPI was developed to measure older patients' self-efficacy in obtaining medical information and attention to their medical concerns from physicians. Scores range from 0-25 with higher scores indicating higher self-efficacy.|12 months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626380|NCT01901211|Secondary|The Self-Worth Domain of the KINDL-R Questionnaire|"The 4-item Self-worth Domain of the KINDL-R will be used as an indicator of self-esteem.~The subscale has 4 items scored on a five-point Likert scale that can be scored in isolation and is converted to percent of total subscale score. Full range of possible scores 0-20. Score is converted to percent of total subscale score (0-100%). Higher scores indicate greater self-worth."|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)|One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.|||percentage of total subscale score||Standard Deviation|Mean
2626381|NCT01901211|Secondary|Total Score of the KINDL-R Questionnaire|"The total score of the 24-item KINDL-R questionnaire will measure the participants' health-related quality of life.~Scores are on a five-point Likert scale that can be scored in isolation and is converted to percent of total score. Total score is the summed score divided by the total possible score. Full range of possible scores 0-120. Score is converted to percent of total subscale score (0-100%). Higher scores indicate greater health related quality of life."|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)|One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.|||percentage of total score on a scale||Standard Deviation|Mean
2626382|NCT01901211|Secondary|Anthropometric Measurements|Anthropometric measurements of waist circumference, triceps and subscapular skinfold thickness, will be used to assess body composition as indicators of physical fitness.|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)|One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.|||cm||Standard Deviation|Mean
2626383|NCT01901211|Secondary|The 30-second Wingate Cycle Test|"The 30-second Wingate Cycle Test is a measure of anaerobic power, a key component of physical fitness. The cycle test is performed when a participant uses a cycle ergometer and pedals as hard as they can for 30-seconds against a constant braking force.~The measure is relative peak power (watts/kg) normalized to body weight. Higher scores indicate greater anaerobic power."|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)|This test was unsuitable for over half the participants, who were unable to complete one or more of the 30-second Wingate tests. Malfunctioning equipment also made collecting full data sets impossible.|||Watts/Kg||Standard Deviation|Mean
2626384|NCT01901211|Secondary|Handheld Dynamometry Measures of Knee Flexors and Knee Extensors|"Handheld dynamometry will be used to measure muscle strength for the quadriceps muscles and the hamstrings at 90˚ of knee flexion in both legs.~The individual sits with legs at 90˚ of knee flexion and resistance will be given anteriorly (knee extensors) and posteriorly (knee flexors) two inches proximal to the lateral malleoli.~Higher score indicates greater strength."|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)|One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.|||pounds||Standard Deviation|Mean
2626385|NCT01901211|Primary|Change in the Social Wellbeing Domain of the KINDL-R Quality of Life Questionnaire|"Wellbeing Related to Friends/Peers domain of the KINDL-R is a four-item subscale focusing on time spent with friends, being perceived as a success with friends, getting along with friends and whether or not they felt different from peers over the past week.~The subscale has 4 items scored on a five-point Likert scale that can be scored in isolation and is converted to percent of total subscale score. Full range of possible scores 0-20. Score is converted to percent of total subscale score (0-100%). Higher scores indicate greater social wellbeing."|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)|One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.|||percentage of total subscale score||Standard Deviation|Mean
2626386|NCT01901211|Primary|Change in the 7.5 Meter Shuttle Run Test for Gross Motor Function Classification Scale (GMFCS) Level III (SRT-III)|The 7.5m Shuttle Run test (SRT-III) is a maximal, running-based, field test that can assess cardiovascular fitness in children with CP GMFCS level III. In the tests, markers are placed 7.5m apart in a square formation. Participants walk from marker to marker according to progressively faster auditory cues from a music device. The assessment is scored by the total number of shuttle run levels that the participant completes to the nearest half shuttle. A higher score is better.|Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2)|One participant was unable to complete post-assessment after Exergaming Arm. Therefore, 11 participants did complete the protocol, as indicated in the participant flow section, however change scores for outcome measures were not calculated for one participant during the Exergaming Arm. This participant was part of the Comparison First group.|||units on a scale||Standard Deviation|Mean
2626416|NCT01900665|Secondary|Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB)|CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Units on a scale||Standard Deviation|Mean
2626387|NCT01901185|Other Pre-specified|Number of Participants With Adverse Events, Serious Adverse Events and Adverse Device Events|An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant that does not necessarily have a causal relationship with study treatment or the device under study. The definition includes worsening of a pre-existing medical condition. A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria: • fatal • life threatening • requires or prolongs in-patient hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. An adverse device effect is any adverse event related to the use of a medical device. Adverse device effects include AEs resulting from insufficient or inadequate instructions for use, malfunction of the device, or from use errors (including errors resulting from normal use, reasonably forseeable misuse or from intentional misuse) of the device.|9 weeks|Safety population|||participants|||Number
2626388|NCT01901185|Secondary|Percentage of Errors in Each Step of the Self-injection Process|For all the nonmissed injections recorded on the Participant Self-injection Questionnaire, the percentage of the following steps in the self-injection process that were not successfully completed out of the total nonmissed injections during Weeks 1 to 5 are reported. If multiple attempts were recorded, all the recorded attempts were considered, regardless whether it was a successful attempt or not. • Error Icon lit up (Question 2) • Could not load cassette successfully (Question 3) • Could not remove purple cassette cap successfully (Question 4) • Could not press start button to begin self-injection successfully (Question 5).|Week 1, Week 2, Week 3, Week 4 and Week 5|Primary analysis set; multiple injection attempts per week are included.|||percentage of errors|total injection attempts||Number
2626389|NCT01901185|Secondary|Percentage of Autoinjector A System Failures|The autoinjector A and prefilled syringe (PFS)/cassettes used by the participants were examined at the end of the study by device engineers. System failure was defined as the failure of the Autoinjector A or PFS/cassette to meet the device design requirements during Weeks 1 to 5. The percentage of system failures is reported out of the total number of injection attempts during the study, including multiple attempts per week.|Week 1, Week 2, Week 3, Week 4 and Week 5|Primary analysis set; multiple injection attempts per week are included.|||percentage of system failures|total injection attempts|95% Confidence Interval|Number
2626390|NCT01901185|Primary|Percentage of Successful Self-injections to Total Non-missed Injections|The successful self-injection of etanercept using the Autoinjector A, as evaluated by the percentage of successful injections of the total nonmissed injections administered by participants in the non-health care setting during Weeks 1 to 5. Successful self-injection was assessed by Question 1 in the Participant Self-injection Questionnaire, which was completed by each participant after each self-injection. Successful injection is defined as the Autoinjector A signaling a complete injection and no liquid medication pooled on your skin.|Week 1, Week 2, Week 3, Week 4 and Week 5|Primary analysis set defined as all nonmissed injections using Autoinjector A during Weeks 1 to 5 for all enrolled participants; in the event of multiple injection attempts, only the last attempt per week was counted.|||percentage of successful injections|nonmissed injections|95% Confidence Interval|Number
2626391|NCT01901146|Secondary|Percentage of Participants With a Pathologic Complete Response in Breast Tissue and Axillary Lymph Nodes and Absence of DCIS|"Pathological complete response was defined as the absence of invasive tumor cells in the breast tissue and axillary lymph node(s) and absence of residual DCIS.~Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites."|3 to 7 weeks after the last dose of study drug in the neoadjuvant phase|pCR evaluable population|||percentage of participants|||Number
2626392|NCT01901146|Secondary|Percentage of Participants With a Pathologic Complete Response in Breast Tissue Only|"Pathologic complete response (pCR) was defined as the absence of invasive tumor cells in the breast tissue, regardless of residual ductal carcinoma in situ (DCIS).~Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites."|3 to 7 weeks after the last dose of study drug in the neoadjuvant phase|pCR evaluable population|||percentage of participants|||Number
2626393|NCT01901146|Primary|Percentage of Participants With a Pathologic Complete Response|"Pathologic complete response (pCR) was defined as the absence of invasive tumor cells in the breast tissue and in axillary lymph nodes, regardless of residual ductal carcinoma in situ (DCIS).~Participants underwent a lumpectomy or mastectomy with sentinel lymph node dissection (SLND) or axillary lymph node dissection (ALND) within 3 to 7 weeks after the last dose of study drug in the neoadjuvant phase. The pathology evaluation of surgical specimens for pCR analysis was conducted by local laboratories at the study sites."|3 to 7 weeks after the last dose of study drug in the neoadjuvant phase|The pCR evaluable population, which included all randomized participants who received any amount of study drug, underwent the surgery, and had a non-missing evaluable pCR assessment from the local laboratory evaluation.|||percentage of participants|||Number
2626394|NCT01900899|Secondary|Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups|Serogroups included MenA, MenC, MenW-135 and MenY.|24, 36, 48, 60 and 72 months after booster Vaccination|All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. N=number of participants evaluable for this outcome measure. ‘Number Analyzed’ = participants evaluable for specified categories.|||titers||95% Confidence Interval|Geometric Mean
2626395|NCT01900899|Secondary|Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups|Serogroups included MenA, MenC, MenW-135 and MenY.|24, 36, 48, 60 and 72 months after booster Vaccination|All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. N=number of participants evaluable for this outcome measure. ‘Number Analyzed’ = participants evaluable for specified categories.|||percentage of participants||95% Confidence Interval|Number
2626396|NCT01900899|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 72 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to the Month 72 after booster vaccination (up to 6 years)|All eligible participants who received primary and booster vaccination with MenACWY-TT or Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen.|||participants|||Number
2626397|NCT01900899|Secondary|Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups|Serogroups included MenA, MenC, MenW-135 and MenY.|24, 36, 48, 60 and 72 months after booster Vaccination|All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. N=number of participants evaluable for this outcome measure. ‘Number Analyzed’ = participants evaluable for specified categories.|||titers||95% Confidence Interval|Geometric Mean
2626398|NCT01900899|Secondary|Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups|Serogroups included MenA, MenC, MenW-135 and MenY.|24, 36, 48, 60 and 72 months after booster Vaccination|All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. N=number of participants evaluable for this outcome measure. ‘Number Analyzed’ = participants evaluable for specified categories.|||percentage of participants||95% Confidence Interval|Number
2626399|NCT01900899|Primary|Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|72 months after booster Vaccination|All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N=number of participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2626400|NCT01900899|Primary|Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|60 months after booster Vaccination|All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N=number of participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2626401|NCT01900899|Primary|Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|48 months after booster Vaccination|All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N=number of participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2626402|NCT01900899|Primary|Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|36 months after booster Vaccination|All eligible participants who received primary and booster vaccination with MenACWY-TT or Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N signifies number of participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2626403|NCT01900899|Primary|Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination|Serogroups included MenA, MenC, MenW-135 and MenY.|24 months after booster Vaccination|All eligible participants who received primary and booster vaccination with MenACWY-TT or Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. N (overall number of participants analyzed)=number of participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2626404|NCT01900730|Primary|Time to Pleural Catheter Removal|Primary outcome is time to pleural catheter removal because it is no longer needed to drain the pleura of fluid. Time to catheter removal measured from the date of placement of the catheter to the date it is removed. Cox (1972) proportional hazards regression used to model time to catheter removal as a function of treatment arm, cytology, and lung re-expansion, as well as other potential prognostic factors, including ECOG performance status, number of circulating tumor cells in peripheral blood and in pleural effusion.|10 weeks|Study terminated early with single patient leaving low accrual with insufficient data for analysis||||||
2626405|NCT01900665|Secondary|Change From Baseline in Cerebrospinal Fluid (CSF) Aβ Levels|Concentration of CSF parameters includes amino acid peptide known as Aβ 1-42 and Aβ 1-42. Analyses of these CSF biomarkers was conducted in a subset of participants (as an addendum to the protocol). The dependent variable for each CSF parameter was its change from baseline to endpoint. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||picogram/milliliter||Standard Error|Least Squares Mean
2626417|NCT01900665|Secondary|Change From Baseline in Functional Activities Questionnaire (FAQ)|FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from financial management, shopping, playing games, food preparation, traveling, keeping appointments, keeping track of current events, and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. A negative change indicated an improvement from baseline. FAQ Total Score is the sum of 10 items, ranging from 0 (best possible outcome) to 100 (worst possible outcome). LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Units on a scale||Standard Error|Least Squares Mean
2626406|NCT01900665|Secondary|Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan|Florbetapir PET imaging was used to confirm the presence of amyloid pathology consistent with AD. Change from baseline was done to test the hypothesis that amyloid burden was reduced in participants in the treatment group. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. The composite summary measure is an unweighted average of the 6 smaller regions (anterior cingulate, frontal medial orbital, parietal, posterior cingulate, precuneus, and temporal) normalized to whole cerebellum or subject-specific white matter.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||standard uptake value ratio||Standard Error|Least Squares Mean
2626407|NCT01900665|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Solanezumab (LY2062430)|Area Under the Concentration versus Time Curve was evaluated for Solanezumab.|Visit 2 (Post-dose), Visit 5, 9, 15 (Pre-dose, Post-dose) and Visit 22 (Pre-dose): Pre-dose before the infusion, Post-dose 30 minutes End of Infusion|All randomized participants who received at least 1 dose of study medication (Solanezumab) with evaluable Solanezumab PK data.|||milligram*hour per milliliter (mg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2626408|NCT01900665|Secondary|Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)|The vMRI assessment of right and left hippocampal atrophy, is reported. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants.|||Cubic millimeter (mm^3)||Standard Deviation|Mean
2626409|NCT01900665|Secondary|Change From Baseline in Plasma Amyloid-Beta (Aβ) Species|Concentration of amino acid peptide known as Aβ 1-42 in plasma. The change in plasma Aβ analytes after treatment were assessed separately for each plasma Aβ parameter. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants.|||Picogram/milliliter||Standard Error|Least Squares Mean
2626410|NCT01900665|Secondary|Percentage of Participants of Cognitive and Functional Responders|Assess the proportion of participants who reach certain levels of cognitive and functional decline. Decline in cognition was defined as worsening from baseline by at least 6 or 9 points on the ADAS Cog14. If there is a cognitive decline of a specified cut-off or more at any time then the participant is considered a nonresponder. Functional nonresponders are participants who have not had any of the following at any time point: Clinically evident decline in ability to perform one or more basic ADL present at baseline; A clinically evident decline in ability to perform 20% or more of the instrumental ADL present at baseline; An increase in global CDR score of 1 point or more compared with baseline. A decline from no impairment to mild impairment (bADL, iADL is not considered clinically significant, but other declines of 1 or more points and any participant discontinuation within the first 6 months will be considered a non-responder.|Baseline through Week 80|All randomized participants.|||percentage of participants|||Number
2626411|NCT01900665|Secondary|Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS)|Integrated Alzheimer's Disease Rating Scale is used to assess that solanezumab slows down the cognitive and functional decline associated with AD compared with placebo. iADRS is a simple linear combination of ADAS-Cog 13 or 14 and the ADCS-iADL. The scale ranges from 0 to 146, where lower scores indicate worse performance. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||units on a scale||Standard Error|Least Squares Mean
2626412|NCT01900665|Secondary|Change From Baseline in 5-Dimensional EuroQol Quality of Life Scale Proxy Version (EQ-5D Proxy)|EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. Visual analog scale (VAS) assesses caregiver's impression of participant's health state; score ranges: 0 to 100 millimeter (mm). Lower scores=greater disease severity LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||mm||Standard Error|Least Squares Mean
2626413|NCT01900665|Secondary|Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD)|Assesses QoL for AD: participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items, rated on a 4-point scale. Sum of items=total score (range: 13 to 52). Higher scores indicate greater QoL. Participant's primary caregiver asked to complete same measure. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Units on a scale||Standard Error|Least Squares Mean
2626414|NCT01900665|Secondary|Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite)|Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation and healthcare resource utilization) was gathered from baseline and follow-up interviews. Reported number of hospitalizations per participant up to 76 weeks. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Number of hospitalizations||Standard Error|Least Squares Mean
2626415|NCT01900665|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI)|NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Units on a scale||Standard Error|Least Squares Mean
2626428|NCT01900652|Secondary|Overall Survival (OS)|OS was defined as duration from the date of study enrollment to the date of death from any cause. Participants not known to have died as of the data inclusion cut-off date were censored at the date of last contact. The last contact for participants in post-discontinuation was the last date participant was known to be alive.|Baseline to Death Due to Any Cause (Up to 24 Months)|All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.|||Months||95% Confidence Interval|Median
2626418|NCT01900665|Secondary|Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Units on a scale||Standard Error|Least Squares Mean
2626419|NCT01900665|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE)|MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Units on a scale||Standard Error|Least Squares Mean
2626420|NCT01900665|Secondary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11)|The cognitive subscale of ADAS (ADAS Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Units on a scale||Standard Error|Least Squares Mean
2626421|NCT01900665|Secondary|Change From Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL)|The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Units on a scale||Standard Error|Least Squares Mean
2626422|NCT01900665|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14)|The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS that was used as the primary efficacy measure consists of 14 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.|Baseline, Week 80|All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data.|||Units on a scale||Standard Error|Least Squares Mean
2626423|NCT01900652|Secondary|Number of Participants With Anti-Emibetuzumab Antibody (ADA) Response||Baseline through 30-Day Follow-Up (Up to 24 Months)|All participants who received at least one dose of study drug and have sufficient Anti-Emibetuzumab Antibody sample for the analysis.|||participants|||Number
2626424|NCT01900652|Secondary|Pharmacokinetics (PK): Area Under the Concentration (AUC) of Emibetuzumab|AUC(0-tlast) = area under the concentration versus time curve from time zero through the last quantifiable sample.|Cycle1 Day 1 (C1 D1): Pre-dose and End of infusion; C1 D8: Pre-dose; C1 D15, C2 D1, C2 D15, C3 D1, C3 D15, C4 D1, C4 D15: Pre-dose and End of Infusion|All participants who received Emibetuzumab on Cycle 1, Day 1, and contributed samples for analysis.|||Microgram*hour/milliliter (ug*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2626425|NCT01900652|Secondary|Change From Baseline in EuroQol 5-Dimensional Scale (EQ-5D)|"The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.~Additionally, participants will indicate their current health status by marking on a continuum ranging from 100 (best imaginable health state) to 0 (worst imaginable health state)."|Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)|All randomized participants with EQ-5D values at baseline.|||units on a scale||Standard Deviation|Mean
2626426|NCT01900652|Secondary|Change From Baseline in EORTC Quality of Life Questionnaires Lung Cancer 13 (QLQ-LC13)|The EORTC lung module QLQ-LC13 comprises 13 items consisting of one multi-item scale to assess dyspnea and a series of single-item measures assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. The higher scores represent a greater degree of symptoms.|Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)|All randomized participants with EORTC QLQ-LC13 values at baseline.|||units on a scale||Standard Deviation|Mean
2626427|NCT01900652|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires C30 (QLQ-C30)|EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.|Baseline, Objective Disease Progression or Participants Stops Study (Up to 24 Months)|All randomized participants with EORTC QLQ-C30 values at baseline.|||units on a scale||Standard Deviation|Mean
2626430|NCT01900652|Secondary|Secondary: Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]|Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control equals (number of participants with CR, PR, or SD)/(number of participants assessed)*100.|Baseline to Objective Disease Progression or Participant Stops Study (Up to 24 Months)|All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.|||percentage of participants||95% Confidence Interval|Number
2626431|NCT01900652|Secondary|Change in Tumor Size (CTS)|Zero participants analyzed. CTS data was not collected for analysis due to N=0 CR and N=3 PR.|Baseline to Measurement with Smallest Tumor Size (Up to 24 Months)|Zero participants analyzed.CTS data was not collected for analysis due to N=0 CR and N=3 PR.||||||
2626432|NCT01900652|Secondary|Time to Progressive Disease||Baseline to Objective Disease Progression (Up to 24 Months)|All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.|||months||95% Confidence Interval|Median
2626433|NCT01900652|Secondary|Progression Free Survival (PFS)|"PFS defined as date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors criteria or death from any cause, whichever is first.~Progressive disease (PD) defined as ≥20% increase in sum of diameter of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non- target lesions. Participants with no baseline disease assessment were censored at randomization date, regardless of whether or not objectively determined PD or death was observed; participants not known to have died or to have objective progression as of data inclusion cutoff were censored at last post baseline radiological assessment date or randomization date, if there was no post baseline radiological assessment."|Baseline to Objective Disease Progression or Death (Up to 24 Months)|All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.|||Months||95% Confidence Interval|Median
2626434|NCT01900652|Primary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.|Baseline to Objective Disease Progression or Start of New Anticancer Therapy (Up to 15 Months)|All participants who are MET diagnostic positive based on the results of their post-erlotinib progression tumor sample and resistance to erlotinib.|||percentage of participants||95% Confidence Interval|Number
2626435|NCT01900626|Secondary|Functional Outcomes: The Owestry Disability Index(ODI)|"Functional outcome will be measured by the Owestry Disability Index (ODI).~ODI represents following disability levels:~0% -20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms."|3 months|This study is being closed due to difficulty with enrollment and changes to standard of care.No data analyses was done||||||
2626436|NCT01900626|Secondary|Functional Outcomes: Scoliosis Research Society-22r (SRS-22r) Patient Questionnaire|Functional outcome will be measured by the Scoliosis Research Society-22r (SRS-22r). Scores range from 0-110, higher scores represent less disability/better outcome|3 months|This study is being closed due to difficulty with enrollment and changes to standard of care.No data analyses was done||||||
2626437|NCT01900626|Secondary|Functional Outcomes:The Pediatric Outcomes Data Collection Instrument (PODCI) Score|Functional outcome will be measured by the Pediatric Outcomes Data Collection Instrument (PODCI). Scores range from 0-100, lower score represents higher degree of disability|3 months|This study is being closed due to difficulty with enrollment and changes to standard of care.No data analyses was done||||||
2626438|NCT01900626|Secondary|Opioid Usage|Hydromorphone usage measured in mcg/kg/day. No min/max. More hydromorphone usage represents worse outcome|72 hours|This study is being closed due to difficulty with enrollment and changes to standard of care.No data analyses was done||||||
2626439|NCT01900626|Secondary|Pain Scores at Rest|The pain scores will be examined using the Numeric Rating Scale (NRS). NRS score ranges from 0-10. Higher score represents more pain/worse outcome|72 hours|This study is being closed due to difficulty with enrollment and changes to standard of care. No participant data was collected for outcome measures||||||
2626440|NCT01900626|Primary|Pain Scores With Activity|The pain scores will be examined using the Numeric Rating Scale (NRS). NRS score ranges from 0-10. Higher score represents more pain/worse outcome|72 hours|This study is being closed due to difficulty with enrollment and changes to standard of care. No participant data was collected for outcome measures||||||
2626441|NCT01900561|Secondary|Veteran Quality of Life Scale (VR-12) - Emotional Health, 3 Items|We assessed subjective emotional health using 3 items from the VR-12 (SF-12 for veterans), an established measure of overall QOL that includes perceptions of one's health that may be impacted by prostate cancer. The scores range from 1- 6 and higher scores correspond to better health.|12 months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626442|NCT01900561|Secondary|Veteran Quality of Life Scale (VR-12) - Physical Health, 2 Items|We assessed subjective physical health using 2 items from the VR-12 (SF-12 for veterans), an established measure of overall QOL that includes perceptions of one's health that may be impacted by prostate cancer. The scores range from 1- 3 and higher scores correspond to better health.|12 months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626446|NCT01900561|Secondary|Perceived Efficacy in Patient-Physician Interactions (PEPPI) - 5-item Short Form|Self-efficacy in patient-physician interactions was assessed at 5 and 12 months using a five-item short form version of the Perceived Efficacy in Patient-Physician Interactions (PEPPI). The PEPPI was developed to measure older patients' self-efficacy in obtaining medical information and attention to their medical concerns from physicians. Scores range from 0-25 with higher scores indicating higher self-efficacy.|5 months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626447|NCT01900561|Secondary|Cancer Outlook|We assessed perceived cancer control and outlook using five items from a validated measure developed to examine the psychosocial impact of prostate cancer. This measure, the Measuring Patients' Perceptions of the Outcomes of Treatment for Early PC instrument by Clark et al., includes three domains related to confidence that one's cancer is under control, worries about recurrence, and appraisals of one's coping with PC. Cancer outlook was assessed during the five- and 12-month follow-ups using three cancer outlook items from the instrument. Scores range from 3 to 15 and higher scores indicate more positive cancer outlook.|12 months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626448|NCT01900561|Secondary|Cancer Outlook|We assessed perceived cancer control and outlook using five items from a validated measure developed to examine the psychosocial impact of prostate cancer. This measure, the Measuring Patients' Perceptions of the Outcomes of Treatment for Early PC instrument by Clark et al., includes three domains related to confidence that one's cancer is under control, worries about recurrence, and appraisals of one's coping with PC. Cancer outlook was assessed during the five- and 12-month follow-ups using three cancer outlook items from the instrument. Scores range from 3 to 15 and higher scores indicate more positive cancer outlook.|5 months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626449|NCT01900561|Secondary|Cancer Control|We assessed perceived cancer control and outlook using five items from a validated measure developed to examine the psychosocial impact of prostate cancer. This measure, the Measuring Patients' Perceptions of the Outcomes of Treatment for Early PC instrument by Clark et al., includes three domains related to confidence that one's cancer is under control, worries about recurrence, and appraisals of one's coping with PC. Cancer control was assessed during the five- and 12-month follow-ups using two cancer control items from the instrument. Scores range from 2 to 10 and higher scores indicate higher confidence that cancer is under control.|12 months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626450|NCT01900561|Secondary|Cancer Control|We assessed perceived cancer control and outlook using five items from a validated measure developed to examine the psychosocial impact of prostate cancer. This measure, the Measuring Patients' Perceptions of the Outcomes of Treatment for Early PC instrument by Clark et al., includes three domains related to confidence that one's cancer is under control, worries about recurrence, and appraisals of one's coping with PC. Cancer control was assessed during the five- and 12-month follow-ups using two cancer control items from the instrument. Scores range from 2 to 10 and higher scores indicate higher confidence that cancer is under control.|5 months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626451|NCT01900561|Primary|Confidence in Symptom Self-Management|Confidence in symptom self-management was measured using a 5-item scale developed from our pilot work. Scores range from 5 to 15 with higher scores indicating higher level of confidence.|12 months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626452|NCT01900561|Primary|Confidence in Symptom Self-Management|Confidence in symptom self-management was measured using a 5-item scale developed from our pilot work. Scores range from 5 to 15 with higher scores indicating higher level of confidence.|5 months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626453|NCT01900561|Primary|The Expanded Prostate Cancer Index (EPIC) - General Health|The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.|12 Months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626454|NCT01900561|Primary|The Expanded Prostate Cancer Index (EPIC) - Sexual Health|The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.|12 Months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626455|NCT01900561|Primary|The Expanded Prostate Cancer Index (EPIC) - Bowel Health|The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.|12 Months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626456|NCT01900561|Primary|The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive|The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.|12 Months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626457|NCT01900561|Primary|The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative|The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.|12 Months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626458|NCT01900561|Primary|The Expanded Prostate Cancer Index (EPIC) - General Health|The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.|5 Months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626459|NCT01900561|Primary|The Expanded Prostate Cancer Index (EPIC) - Sexual Health|The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.|5 Months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626460|NCT01900561|Primary|The Expanded Prostate Cancer Index (EPIC) - Bowel Health|The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.|5 Months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626461|NCT01900561|Primary|The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive|The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.|5 Months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626462|NCT01900561|Primary|The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative|The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.|5 Months|N with non-missing data for the specific measure|||score on a scale||Standard Deviation|Mean
2626463|NCT01900561|Primary|The Expanded Prostate Cancer Index (EPIC) - EPIC-26 Mean|"The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.~The EPIC-26 mean is the average of the five EPIC subscales."|Baseline|Average of 5 EPIC-26 subscales based on 524 person data (260 in control and 264 in IVR group): 30 (5.4%) enrollees did not do EPIC-26, and two enrollees did only one or two subscales. EPIC-Urinary Health Irritative was not done in 30 persons, Urinary Health Obstructive in 31, Bowel Health in 32, Sexual Health in 58 and General Health in 32 persons|||score on a scale||Standard Deviation|Mean
2626464|NCT01900561|Primary|The Expanded Prostate Cancer Index (EPIC) - General Health|The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.|Baseline|Thirty (5.4%) enrollees did not do EPIC-26, and two enrollees did only one or two subscales. EPIC-General Health was not done in 32 persons.|||score on a scale||Standard Deviation|Mean
2626465|NCT01900561|Primary|The Expanded Prostate Cancer Index (EPIC) - Sexual Health|The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.|Baseline|Thirty (5.4%) enrollees did not do EPIC-26, and two enrollees did only one or two subscales. EPIC-Sexual Health was not done in 58 persons.|||score on a scale||Standard Deviation|Mean
2626466|NCT01900561|Primary|The Expanded Prostate Cancer Index (EPIC) - Bowel Health|The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.|Baseline|Thirty (5.4%) enrollees did not do EPIC-26, and two enrollees did only one or two subscales. EPIC-Bowel Health was not done in 32 persons.|||score on a scale||Standard Deviation|Mean
2626467|NCT01900561|Primary|The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Obstructive|The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.|Baseline|Thirty (5.4%) enrollees did not do EPIC-26, and two enrollees did only one or two subscales. EPIC-Urinary Health Obstructive was not done in 31 persons.|||score on a scale||Standard Deviation|Mean
2626468|NCT01900561|Primary|The Expanded Prostate Cancer Index (EPIC) - Urinary Health, Irritative|The EPIC is a 26-item measure that assesses symptom burden in four domains: urinary symptoms, bowel symptoms, sexual symptoms and vitality. Each domain has a subscale related to function and bother which together contribute to disease specific quality of life. Each domain has a range of possible scores from 0 to 100, with lower scores indicating worse symptom burden. Lower EPIC scores for any one domain are associated with lower function in that domain and lower QOL. Thus higher symptom burden, which reflects both function and bother scores, translate into lower EPIC scores.|Baseline|Thirty (5.4%) enrollees did not do EPIC-26.|||score on a scale||Standard Deviation|Mean
2626469|NCT01900444|Primary|Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization|JE virus neutralizing antibodies were measured using PRNT50.|Day 0 (pre-booster) and Day 28 post-booster injection|Geometric mean titer ratios of JE virus antibodies were assessed in the Per Protocol Analysis Set.|||Ratio||95% Confidence Interval|Geometric Mean
2626470|NCT01900444|Primary|Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV At Different Intervals After Primary Immunization|JE virus neutralizing antibodies were measured using PRNT50.|Day 0 (pre-booster) and Day 28 post-booster injection|Geometric mean titers of JE virus antibodies were assessed in the Per Protocol Analysis Set.|||Titer||95% Confidence Interval|Geometric Mean
2626471|NCT01900444|Primary|Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization|JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4 fold increase from pre- to post-vaccination.|Day 28 post-booster injection|Seroconversion rates were assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2626472|NCT01900444|Primary|Percentage of Participants With JE Seroprotection Before and After a Booster Dose of IMOJEV Given At Different Intervals After Primary Immunization|JE virus neutralizing antibodies were measured using PRNT50. Seroprotection was defined as neutralizing antibody titer ≥ 10 (1/dilution).|Day 0 (pre-booster) and Day 28 post-booster injection|Seroprotection rates were assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2626473|NCT01900444|Primary|Summary of Geometric Mean Titer Ratios of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization|JE virus neutralizing antibodies were measured using PRNT50.|Day 0 (pre-booster) and Day 28 post-booster injection|Geometric mean titer ratios of JE virus antibodies were assessed in the Per Protocol Analysis Set.|||Ratio||95% Confidence Interval|Geometric Mean
2626474|NCT01900444|Primary|Summary of Geometric Mean Titers of JE Virus Antibodies Following a Booster Dose of IMOJEV Given One Year After Primary Immunization|JE virus neutralizing antibodies were measured using PRNT50 test.|Day 0 (pre-booster) and Day 28 post-booster injection|Geometric mean titers of JE virus antibodies were assessed in the Per Protocol Analysis Set.|||Titer||95% Confidence Interval|Geometric Mean
2626475|NCT01900444|Primary|Percentage of Participants With JE Seroconversion Following a Booster Dose of IMOJEV Given One Year After Primary Immunization|JE virus neutralizing antibodies were measured using PRNT50. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and post-vaccination titer ≥10 (1/dilution, or pre-vaccination titer ≥10 (1/dilution) and a ≥4-fold increase of titers from pre- to post-vaccination.|Day 28 post-booster injection|Seroconversion rates were assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2626476|NCT01900444|Primary|Percentage of Participants With JE Seroprotection Before and Following a Booster Dose of IMOJEV Given One Year After Primary Immunization|JE virus neutralizing antibodies were measured using a 50% plaque reduction neutralization test (PRNT50). Seroprotection status for antibody levels against JE virus before and after IMOJEV vaccination was defined as antibody titers ≥ 10 (1/dilution).|Day 0 (pre-booster) and Day 28 post-booster injection|Seroprotection rates were assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2626477|NCT01900431|Secondary|Pharmacokinetics (PK) Assessment: Serum Functional Sarilumab Concentration|Serum functional (unbound) sarilumab concentrations were determined using an enzyme-linked immunosorbent assay (ELISA) method with a lower limit of quantification (LLOQ) of 294 ng/mL. Concentrations below LLOQ were set to zero for samples at predose. Post-treatment concentrations below LLOQ were replaced by LLOQ/2. The samples were considered non-eligible for the analysis if the previous dosing time was <11 days or >17 days before the sampling time for every other week regimens.|Predose on Day 1 (Baseline), Week 2, 4, 8, 12, 16, 24, 36, 52, and end of study (EOS) (Week 56)|PK population: all participants who received at least one dose or part of a dose of investigational medicinal product (IMP) with at least one post-dose, non-missing serum concentration value and were analyzed according to treatment actually received. Data of this endpoint was planned to be analyzed for Sarilumab 200 mg q2w arm in Part A and B only.|||ng/mL||Standard Deviation|Mean
2635245|NCT01806506|Secondary|LDH Level||12 months|||||||
2626478|NCT01900431|Secondary|Percentage of Participants With Prednisone Dose of ≤5 mg/Day (or Equivalent Oral Corticosteroid) at Week 16|Participants with prednisone dose ≤5 mg/day (or equivalent oral corticosteroid) at Week 16 were evaluated.|Week 16|Analysis was performed on mITT population. Number of participants analyzed = participants with non-missing data for prednisone (or equivalent oral corticosteroid) dose at Week 16.|||Percentage of participants|||Number
2626479|NCT01900431|Secondary|Percentage of Participants Without Retinal Vessel Leakage on Fluorescein Angiography (FA) at Week 16||Week 16|Analysis of this endpoint was not performed as no retinal vessel leakage data was collected at Week 16. Zero participants were analyzed.||||||
2626480|NCT01900431|Secondary|Percentage of Participants With CRT Thickness <300 Microns at Week 16||Week 16|This endpoint was replaced by the percent change from baseline in CRT at Week 16 as this is more clinically relevant. Zero participant was analyzed.||||||
2626481|NCT01900431|Secondary|Percent Change From Baseline in CRT at Week 16|CRT was measured by SD-OCT, a non-invasive diagnostic system providing high-resolution imaging sections of the retina. All images were transmitted to the central reading center. SD-OCT was performed in the study eye after pupil dilation. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT.|Baseline to Week 16|Analysis was performed on mITT population. Number of participants analyzed = participants with CRT assessment at baseline and post-baseline visits.|||percent change||Standard Error|Least Squares Mean
2626482|NCT01900431|Secondary|Change From Baseline in Central Retinal Thickness (CRT) At Week 16|CRT was measured by spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. All images were transmitted to the central reading center. SD-OCT was performed in the study eye after pupil dilation. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline CRT.|Baseline to Week 16|Analysis was performed on mITT population. Number of participants analyzed = participants with CRT assessment at baseline and post-baseline visits.|||µm (microns)||Standard Error|Least Squares Mean
2626483|NCT01900431|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 16|BCVA score is based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters, and then at 1 meter. The range of ETDRS is 0 to 100 letters. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. LS mean was calculated using MMRM model with treatment groups, randomization strata of VH level (<4, >=4), visits and visit-by-treatment groups interaction as fixed categorical effects, as well as, fixed continuous covariate of baseline BCVA.|Baseline to Week 16|Analysis was performed on mITT population. Number of participants analyzed = participants with BCVA score assessment at baseline and post-baseline visits.|||units on a scale||Standard Error|Least Squares Mean
2626484|NCT01900431|Secondary|Percentage of Participants With Anterior Chamber (AC) Cell Score = 0 or At Least 2-step Reduction in Score at Week 16|Participants with AC cell score = 0 or with ≥2 step reduction from baseline at Week 16 were evaluated. Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: grade 0 = no cells; grade +0.5 = 1 - 5 cells; grade +1 = 6 - 25 cells; grade +2= 26 - 50 cells; grade +3 = too many to count.|Week 16|Analysis was performed on mITT population. Number of participants analyzed = participants with non-missing AC cell score at Week 16.|||Percentage of participants|||Number
2626485|NCT01900431|Secondary|Change From Baseline in VH Scale at Week 16|Change from baseline in VH scale was evaluated on Miami 9-step scale. VH is the obscuration of fundus by vitreous cells and protein exudation. Each of the 9-step scale (from grade 0 [low opacity] to 8 [more opacity]) images (in increasing order of opacity) were equivalent to approximately 0.3 log units of degradation in visual acuity based on the Bangerter calibration. Least squares (LS) mean was calculated using mixed model for repeated measurements (MMRM) model with treatment groups, visits and visit-by-treatment groups interaction as fixed categorical effects as well as fixed continuous covariate of baseline adjudicated VH.|Baseline to Week 16|Analysis was performed on mITT population. Number of participants analyzed = participants with VH assessment at baseline and post-baseline visits.|||units on a scale||Standard Error|Least Squares Mean
2626486|NCT01900431|Primary|Percentage of Participants With at Least 2-step Reduction in Vitreous Haze (VH) or Prednisone Dose <10 mg/Day at Week 16|At least 2-step reduction in VH per central review from baseline was evaluated on Miami 9-step scale. VH is the obscuration of fundus by vitreous cells and protein exudation. Each of the 9-step scale (from grade 0 [low opacity] to 8 [more opacity]) images (in increasing order of opacity) are equivalent to approximately 0.3 log units of degradation in visual acuity based on the Bangerter calibration. Participants with prednisone dose <10 mg/day (or equivalent oral corticosteroid) were also evaluated.|Week 16|Modified intent-to-treat population (mITT) included all randomized participants who received at least 1 injection analyzed according to the group to which the participant was allocated by the randomization schedule. Modified multiple imputation approach was used on VH missing adjudicated scores.|||Percentage of participants|||Number
2626487|NCT01900392|Primary|Change in Weight From Baseline to 12 Months||12 months||||kilograms||Standard Deviation|Mean
2626488|NCT01900392|Primary|Change in Weight From Baseline to 6 Months||6 months||||kilograms||Standard Deviation|Mean
2626489|NCT01900314|Secondary|Depression Symptoms at 4 Weeks- Secondary|Depressive symptoms as measured by the 17-item Hamilton Depression Rating Scale (HRSD17) Range: 0-53 Normal: 0-7 Mild: 8 - 13 Moderate 14 - 18 Severe: 19-22 Very severe > 22|4 weeks after baseline|Sample analyzed included all participants who entered the study and received MRI scans at baseline and after 4 weeks of treatment. Repeated measures ANCOVA with screening MADRS score as co-variate|||units on a scale||Standard Deviation|Mean
2626490|NCT01900314|Primary|Depressive Symptoms at 4 Weeks|MADRS: Montgomery Asberg Depression Rating Scale Range: 0 - 60 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression|4 weeks after baseline||||units on a scale||Standard Deviation|Mean
2629498|NCT01865448|Secondary|Body Mass Index at 6 Months|Body mass index at 6 months (end of the monitoring period)|6 months||||kg/m^2||Standard Deviation|Mean
2626491|NCT01900249|Primary|Change of Corneal Fluorescein Staining of the Inferior Cornea Region.|Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea.|Baseline to Week 12|The intent to treat population (ITT) included all randomized subjects who administered study medication. The primary analysis was performed on the ITT population.|||units on a scale (Likert)||95% Confidence Interval|Mean
2626492|NCT01900067|Primary|The Difference in the Arithmetic Mean of Core Body Temperature Measurements During the Perioperative Phase Between the Interventional Treatment Group and the Control Treatment Group|The subject's core body temperature at any time point is approximated by the arithmetic mean of three repeated tympanic temperature measurements every 15 minutes during the perioperative period|temperature measurments during pre,-intra and postoperative period, on average 1-5 hours, depending on the surgical intervention.||||Degree Celsius (°C)||95% Confidence Interval|Mean
2626493|NCT01900054|Secondary|Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)||Week 12 or suspension|||||||
2626494|NCT01900054|Secondary|Influence of Activities in Daily Life(Study, Outing, Sleeping)||Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12|||||||
2626495|NCT01900054|Secondary|Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis||baseline, Week2, Week4, Week6, Week8, Week10 and Week 12|||||||
2626496|NCT01900054|Secondary|Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)||Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12|||||||
2626497|NCT01900054|Secondary|Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)||baseline, Week2, Week4, Week6, Week8, Week10 and Week 12|||||||
2626498|NCT01900054|Secondary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point.|Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptom) to 4 (very severe).|Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12）||||units on a scale||Standard Deviation|Median
2626499|NCT01900054|Primary|Number of Patients With Adverse Events and Adverse Drug Reactions||Up to Week 12||||participants|||Number
2626500|NCT01899911|Primary|Composite Outcome Measure: Successful Capture of Peripheral Capillary Oxygen Saturation (SpO2) Level|Successful capture of SpO2 levels - Infrared and red light absorbency was measured and used for SpO2 percentage calculation from both the Vital Signs Patch (VSP) study device and an invasive Blood Arterial Hemoximeter (standard method) to determine the level of accuracy of data obtained from the VSP device when compared data taken from the Arterial Hemoximeter. A comparison was made by calculating the Average Root Mean Square (Arms) and comparing against the Arms error rate limit of less than or equal to 3.5% at a 95% confidence level. The outcome is either positive or negative - this is a composite outcome measure.|within 24 hrs|Peripheral capillary oxygen saturation (SpO2) Measurements Taken on the 12 Participants|||participants|||Number
2626501|NCT01899768|Secondary|CAC Agent Imputed Dose Concentration Required to Achieve C2, C5 and C6 at Visits 6 and 7 (Part C)|CAC was performed following the administration of GSK2339345 or placebo at Visits 6 and 7. CA was administered using a dosimeter through a nebulizer pot with flow-limitation. Number of coughs in the first and second 15 sec following each dose of CAC agent were recorded. Inhalation of increased Conc. was continued until the maximum dose was tolerated by the participants or the highest available Conc. was used. CAC agent imputed dose concentration required to achieve C2 (at which 2 coughs were first observed [FO]), C5 (at which 5 coughs were FO) and C6 (at which 6 coughs were FO) are presented. For participants who did not complete the challenge and not reached the endpoint, values were imputed to the next dose in the challenge sequence after stopping. For participants who completed the challenge and had not reached the endpoint, values were imputed to 2000 (=twice the highest dose of CA).|After the administration of GSK2339345 or placebo at Visits 6 and 7 in Part C (up to 2 weeks)|CAC Population|||mol/L||Geometric Coefficient of Variation|Geometric Mean
2626502|NCT01899768|Secondary|CC Agent Imputed Dose Concentration Required to Achieve C2, C5 and C6 at Visits 4 and 5 (Part B)|CC was performed following the administration of GSK2339345 or placebo at Visits 4 and 5. Capsaicin was administered using a dosimeter through a nebulizer. The number of coughs in the first and second 15 sec following each dose of CC agent were recorded. Inhalation of increased Conc. was continued until the maximum dose was tolerated by the participant or the highest available Conc. was used. CC agent imputed dose concentration required to achieve C2 (at which 2 coughs were first observed [FO]), C5 (at which 5 coughs were FO) and C6 (at which 6 coughs were FO) are presented. For participants who did not complete the challenge and not reached the endpoint, values were imputed to the next dose in the challenge sequence after stopping. For participants who completed the challenge and had not reached the endpoint, values were imputed to 2000 (=twice the highest dose of capsaicin).|After the administration of GSK2339345 or placebo at Visits 4 and 5 in Part B (up to 2 weeks)|CC Population|||µmol/L||Geometric Coefficient of Variation|Geometric Mean
2626503|NCT01899768|Secondary|CAC Agent Dose Concentration Required to Achieve C2, C5 and C6 at Visits 6 and 7 (Part C)|CAC was performed following the administration of GSK2339345 or placebo at Visits 6 and 7. CA was administered using a dosimeter through a nebulizer pot with flow-limitation. Number of coughs in the first and second 15 sec following each dose of CAC agent were recorded. Inhalation of increased conc. was continued until the maximum dose was tolerated by the participants or the highest available Conc. was used. CAC agent dose concentration required to achieve C2 (2 coughs were first observed [FO]), C5 (5 coughs were FO) and C6 (6 coughs were FO) are presented. All instances of missing values occurred where a participant did not achieved the required number of coughs for a parameter.|After the administration of GSK2339345 or placebo at Visits 6 and 7 in Part C (up to 2 weeks)|CAC population: Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the CAC Population.|||mol/L||Geometric Coefficient of Variation|Geometric Mean
2626735|NCT01897792|Primary|Number of Subjects With Ventilator-associated Pneumonia.|Number of subjects diagnosed with pneumonia and requiring ventilator support.|From enrollment to 3 days||||participants|||Number
2635246|NCT01806506|Secondary|ALP Level||12 months|||||||
2626504|NCT01899768|Secondary|CC Agent Dose Concentration Required to Achieve C2, C5 and C6 at Visits 4 and 5 (Part B)|CC was performed following the administration of GSK2339345 or placebo at Visits 4 and 5. Capsaicin was administered using a dosimeter through a nebulizer. The number of coughs in the first and second 15 sec following each dose of CC agent were recorded. Inhalation of increased conc. was continued until the maximum dose was tolerated by the participant or the highest available conc. was used. CC agent dose concentration required to achieve C2 (2 coughs were first observed [FO]), C5 (5 coughs were FO) and C6 (6 coughs were FO) are presented. All instances of missing values occurred where a participant did not achieved the required number of coughs for a parameter.|After the administration of GSK2339345 or placebo at Visits 4 and 5 in Part B (up to 2 weeks)|CC population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the CC Population.|||µmol/L||Geometric Coefficient of Variation|Geometric Mean
2626505|NCT01899768|Secondary|Mean Number of Cough Counts at Each Dose of the Challenge Agent for the Citric Acid Challenge (CAC)at Visits 6 and 7 (Part C)|Citric acid was administered using a dosimeter through a nebulizer pot with flow-limitation. Inhalation of increased Conc. was continued until the maximum dose was tolerated by the par. or the highest available Conc. was used. The dose-response relationship between the dose of citric acid and cough response was investigated using non-linear mixed effect modelling using Poisson and Negative Binomial distributions. When using a Poisson distribution, there was some evidence for an increase in citric acid ED50 with GSK2339345 of 41.6%, however, this was not confirmed when using a Negative Binomial distribution. The Negative Binomial distribution described the data marginally better, but the dataset was too small to make definitive conclusions. There was no treatment difference in citric acid Emax|After the administration of GSK2339345 or placebo (first and second 15 seconds following each dose) at Visits 6 and 7 in Part C (up to 2 weeks)|CAC Population comprised of participants in the All Subjects Population for whom any CAC data were available for one or both Part C study visits. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Cough count||Standard Deviation|Mean
2626506|NCT01899768|Secondary|Mean Number of Cough Counts at Each Dose of the Challenge Agent for the Capsaicin Challenge (CC) at Visits 4 and 5 (Part B)|Capsaicin was administered using a dosimeter through a nebulizer pot with flow-limitation. Inhalation of increased concentrations (Conc.) was continued until the maximum dose was tolerated by the par. or highest available Conc. was used. The dose-response relationship between dose of capsaicin and cough response was investigated using non-linear mixed effect modeling using Poisson and Negative Binomial distributions. When using a Poisson distribution, there was some evidence for a reduction in capsaicin Emax with GSK2339345 of 17.6%, however, this was not confirmed when using a Negative Binomial distribution. The Negative Binomial distribution described the data marginally better, but the dataset was too small to make definitive conclusions. There was no treatment difference in capsaicin ED50.|After the administration of GSK2339345 or placebo (first and second 15 seconds following each dose) at Visits 4 and 5 in Part B (up to 2 weeks)|CC population. Population comprised of par. in the All Subjects Population for whom any CC data were available for one or both Part B study visits. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).|||Cough count||Standard Deviation|Mean
2626507|NCT01899768|Secondary|Mean Visual Analogue Scale (VAS) Score of Cough Severity and Urge to Cough at the Indicated Time Points at Visits 1, 2 and 3 (Part A)|VAS for urge to cough and severity of cough were recorded prior to first dose and 1 hour following the second dose of GSK2339345 or placebo at Visits 1, 2 and 3.VAS is a 100-mm linear scales on which participants indicated the severity of their cough (0 mm represents no severity and 100 mm maximum severity ever experienced) and urge to cough (0 represents no urge to cough, 100 represents maximum urge to cough ever experienced). Mean of replicate values per participants used where the same treatment taken during different periods.|Prior to first dose and 1hr post second dose at Visits 1, 2 and 3 in Part A (up to 3 weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Scores on a scale||Standard Deviation|Mean
2626508|NCT01899768|Secondary|Mean Cough Counts by 15 Min Epoch in Part A|Cough counts (8 hr of recording) were conducted at Visits 1, 2 and 3 (4-hr of post-dose recording for each of the two doses administered). Coughs were counted by a cough monitor fitted to the participant for 8 hr post Dose 1. The first epoch started at the time of the first dose, and the 15 min time periods continued until an epoch ended immediately before the second dose (or 4h after the first dose if earlier). The epochs were then re-started at the start of the second dose at 15 min intervals, finishing with an epoch which ran to 4-hr after the start of the second dose. The cough counts were sum-up by the treatments received by the participants. Mean cough count was calculated per participant if the same treatment was taken during different periods.|Up to 8 hours post-dose at Visits 1, 2 and 3 in Part A (up to 3 weeks)|All Subjects Population. Only those participants with a 15 min cough count value were analyzed.|||Cough count||Standard Deviation|Mean
2626509|NCT01899768|Secondary|Mean Cough Counts by 30 Min Epoch at Visits 1, 2 and 3 (Part A)|Cough counts (8 hr of recording) were conducted at Visits 1, 2 and 3 (4-hr of post-dose recording for each of the two doses administered). Coughs were counted by a cough monitor fitted to the participant for 8 hr post Dose 1. The first epoch started at the time of the first dose, and the 30 min time periods continued until an epoch ended immediately before the second dose (or 4-hr after the first dose if earlier). The epochs were then re-started at the start of the second dose at 30 min intervals, finishing with an epoch which ran to 4-hr after the start of the second dose. The cough counts were sum-up by the treatments received by the participants. Mean cough count was calculated per participant if the same treatment was taken during different periods.|Up to 8 hours post-dose in Visits 1, 2 and 3 in Part A (up to 3 weeks)|All Subjects Population. Only those participants with a 30 min cough count value were analyzed.|||Cough count||Standard Deviation|Mean
2626765|NCT01897402|Secondary|Solicited Adverse Events From Diary Cards|Local and systemic rates from Diary Cards filled by the participants.|Day 0 to Day 7 after vaccination|Safety Population: All vaccinated participants, grouped by actual vaccine received.|||percentage of participants|||Number
2629499|NCT01865448|Secondary|Weight at 6 Months|Weight at 6 months (end of the monitoring period)|6 months||||kg||Standard Deviation|Mean
2626510|NCT01899768|Secondary|Mean Cough Counts by 1 hr Epoch at Visits 1, 2 and 3 (Part A)|Cough counts (8 hr of recording) were conducted at Visits 1, 2 and 3 (4-hr of post-dose recording for each of the two doses administered). Coughs were counted by a cough monitor fitted to the participant for 8 hr post Dose 1. The first epoch started at the time of the first dose, and the 60 min time periods continued until an epoch ended immediately before the second dose (or 4-hr after the first dose if earlier). The epochs were then re-started at the start of the second dose at 60 min intervals, finishing with an epoch which ran to 4-hrs after the start of the second dose. The cough counts were sum-up by the treatments received by the participants. Mean cough count was calculated per participant if the same treatment was taken during different periods. Values were imputed pro-rata if 1 hr epoch is less than 60 min.|Up to 8 hours post-dose at Visits 1, 2 and 3 in Part A (up to 3 weeks)|All Subjects Population. Only those participants with a 1 hr cough count value were analyzed.|||Cough count||Standard Deviation|Mean
2626511|NCT01899768|Secondary|Total Cough Count Excluding Transient Coughs Over 4 Hours at Visits 1, 2 and 3 (Part A)|Total cough count (8 hr of recording) was conducted at Visits 1, 2 and 3 (4-hrs of post-dose recording for each of the two doses administered). Coughs were counted by a cough monitor fitted to the participants for 8 hr post Dose 1. Total count excluding transient cough over 4-hrs was done by using the sum of first 4-hrs starting from the time of first dose and the second 4-hrs starting at the time of the second dose respectively. Number of coughs excluding transient cough in 0-4 hr and 4-8 hr period was log-e transformed and used for the analysis. Values were imputed pro-rata if 4-hr epoch was less than 4-hrs. Mean of the total cough counts over 4-hrs recorded post dose of every treatment i.e. placebo or GSK2339345 1000 mcg was reported.|Up to 8 hours post-dose at Visits 1, 2 and 3 (Part A)|All Subjects Population. Only participants with at least one 4 hr cough count were analyzed.|||Cough count||Standard Error|Geometric Mean
2626512|NCT01899768|Secondary|Mean Cough Count Over 4 Hours at Visits 1, 2 and 3 (Part A)|Total cough count (8 hr of recording) was conducted at Visits 1, 2 and 3 (4- hrs of post-dose recording for each of the two doses administered). Coughs were counted by a cough monitor fitted to the participants for 8 hr post Dose 1. The cough count over 4-hrs was done by using the sum of first 4-hrs starting from the time of first dose and the second 4-hrs starting at the time of the second dose respectively. Number of coughs in 0-4 hr and 4-8 hr period was log-e transformed and used for the analysis. Values were imputed pro-rata if 4 hr epoch was less than 4 hr. Mean of the total cough counts over 4-hrs recorded post dose of every treatment i.e. placebo or GSK2339345 1000 mcg was reported.|Up to 8 hours post-dose at Visits 1, 2 and 3 (Part A)|All Subjects Population. Only participants with at least one 4 hr cough count were analyzed.|||Cough count||Standard Error|Geometric Mean
2626513|NCT01899768|Secondary|Time to Reach the Observed Maximum Concentration (Tmax) of GSK2339345 Following Two Repeated Doses|Tmax is defined as the time to reach the observed maximum GSK2339345concentration following two repeated doses at each visit in Part A. Samples were collected at the following time points: pre-dose; 2 min, 5 min, 10 min, 30 min, 1 hr and 2hr (only after Dose 1) post every dose administered at Visits 1, 2 and 3. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|From 0-4 hr post each dose administered at Visits 1, 2 and 3 in Part A (up to 3 weeks)|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hours||Full Range|Median
2626514|NCT01899768|Secondary|Maximum Observed Concentration (Cmax) of GSK2339345 Following Two Repeated Doses|Cmax is defined as the maximum observed concentration of GSK2339345 following two repeated doses at each visit in Part A. Samples were collected at the following time points: pre-dose; 2 min, 5 min, 10 min, 30 min, 1 hr and 2hr (only after Dose 1) post every dose administration at Visits 1, 2 and 3. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. For Cmax, NCs were imputed prior to derivation of summary statistics and NCs were imputed with 0.5*LLQ (LLQ=0.20 ng/mL).|From 0-4 hr post each dose administered at Visits 1, 2 and 3 in Part A (up to 3 weeks)|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2626515|NCT01899768|Secondary|Area Under the Concentration (AUC) Time (0-1) and AUC(0-t) of GSK2339345 Following Two Repeated Doses|AUC curve from time zero (pre-dose) to 1 hours AUC(0-1) and from time zero to the last time AUC(0-t) of quantifiable concentration of GSK2339345 following the first dose and second dose at each visit in Part A was measured. Samples were collected at the following time points: pre-dose; 2 min, 5 min, 10 min, 30 min, 1 hr and 2hr (only after Dose 1) post every dose administration at Visits 1, 2 and 3. For , AUC(0-1) and AUC(0-t), non calculable (NC) were imputed prior to derivation of summary statistics and NCs were imputed as 0.1093 and 0.0855 respectively (=half the lowest observed value).|From 0-4 hr post each dose administered at Visits 1, 2 and 3 in Part A (up to 3 weeks)|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.|||hour*nanogram per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2626516|NCT01899768|Secondary|Plasma Concentrations of GSK2339345 at the Indicated Time Points at Visits 1, 2 and 3 (Part A)|Plasma concentrations of GSK2339345 following the first dose and second dose at each visit in Part A was measured. Samples were collected at the following time points: pre-dose, 2 min, 5 min, 10 min, 30 min, 1 hr and 2 hr (only after Dose 1) after each dose administration at Visits 1, 2 and 3. All non-quantifiable (NQ) values after the pre-first dose value imputed to half lower limit of quantification (LLQ) (LLQ=0.2 nanogram per milliliter [ng/mL]). Different participants may have been analyzed for different parameters, so the overall number of par. analyzed reflects everyone in the pharmacokinetic population.|From 0-4 hr post each dose administered at Visits 1, 2 and 3 in Part A (up to 3 weeks)|The Pharmacokinetic (PK) Population comprised of participants in the All Subjects Population for whom a pharmacokinetic sample was obtained and analysed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||nanogram per milliliter (ng/mL)||Full Range|Median
2626517|NCT01899768|Secondary|Mean Transient Cough Counts at the Indicated Time Points in Part A|Cough counts (8 hours of recording) was conducted at Visits 1, 2 and 3 (4 hours of post-dose recording for each of the two doses administered). Coughs was counted by a cough monitor fitted to the participants for 8 hours post Dose 1. Transient coughing was calculated as the total number of coughs experienced in the two minutes from the start of the first inhalation of a dose. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A|0-4 hr, 4-8 hr, 0-8 hr post each dose at Visits 1, 2 and 3 in Part A (up to 8 weeks)|All Subjects Population.Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Cough count||Standard Deviation|Mean
2626518|NCT01899768|Secondary|Number of Participants With Perception of Change in Oropharyngeal Sensation at the Indicated Time Points in Part A|The perception of change in oropharyngeal sensation was assessed by a 4 point scale where participants were asked to describe sensitivity and perception of numbness and the responses were recorded. The following information was collected: 0 = no anaesthesia (A), 1 = mild anaesthesia, 2 = moderate anaesthesia and 3 = severe anaesthesia. Oropharyngeal examination was performed at 2 min, 5 min, 15 min, 30 min, 1 hr and 2 hr after FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A|From 2 min -2 hr post each dose administered at Visits 1, 2 and 3 in Part A (up to 8 weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Participants|||Number
2626519|NCT01899768|Secondary|Mean Forced Expiratory Volume in One Second (FEV1) Values at the Indicated Time Points in Parts A, B and C|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured by spirometry at pre-dose and 30 min after FA and SA in Part A and each administration in Parts B, and C. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 30 min post each dose administered in Parts A, B and C (up to 8 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters||Standard Deviation|Mean
2626520|NCT01899768|Secondary|Mean Troponin I Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of troponin I at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. Cardiac troponin values that were below the quantification limit [0.02 or 0.04 microgram (mcg/L)] were imputed as 0.01 (mcg/L).|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||mcg/L||Standard Deviation|Mean
2626521|NCT01899768|Secondary|Mean Calcium, Chloride, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of calcium, chloride, glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2626522|NCT01899768|Secondary|Mean Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement ofdirect bilirubin, total bilirubin, creatinine and uric acid at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2626523|NCT01899768|Secondary|Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of ALP, ALT, AST and GGT at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||International Units/Liter (IU/L)||Standard Deviation|Mean
2627241|NCT01892267|Secondary|Time to Repeat Endoscopy for Tube Replacement|If repeate endocopy and tube placement are needed due to clogging or retrograde migration|2 years|Study terminated prematurely, so that the appropriate follow-up data was not collected.||||||
2635247|NCT01806506|Secondary|GGT Level||12 months|||||||
2626524|NCT01899768|Secondary|Mean Red Blood Cell Count Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of red blood cell count at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All subject population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
2626525|NCT01899768|Secondary|Mean Corpuscle Volume Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of mean corpuscle volume at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||femtoliters per cell (fL)||Standard Deviation|Mean
2626526|NCT01899768|Secondary|Mean Corpuscle Hemoglobin Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of mean corpuscle hemoglobin at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All subject population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||picograms per cell (pg)||Standard Deviation|Mean
2626527|NCT01899768|Secondary|Mean Hematocrit Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of hematocrit at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All subject population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Proportion of one||Standard Deviation|Mean
2626528|NCT01899768|Secondary|Mean Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin and Total Protein Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of hemoglobin, MCHC, albumin and total protein at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All subject population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter (G/L)||Standard Deviation|Mean
2626529|NCT01899768|Secondary|Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cells (WBC) Count Values at the Indicated Time Points in Part A|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC - absolute neutrophil count), platelet count, and white blood cells count at pre-dose and 1 hr after each dose of FA and SA in Part A. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|Pre-dose and 1 hr post each dose administered in Part A (up to 3 Weeks)|All subject population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^9 cells/Liter (GI/L)||Standard Deviation|Mean
2626530|NCT01899768|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings in Parts A, B and C|A 12-lead ECG was recorded in a seated position after the participant was kept at rest in this position for at least 10 minutes. ECGs were obtained at pre-dose and 5 min, 15 min (only in Part A) 30 min, and 1 hr after FA and SA in Part A and each administration in Parts B, and C. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings any time during study. The study investigator determined if the abnormal ECG finding was CS or NCS.|Pre-dose and 5min to 1 hr after each dose administered in Parts A, B and C (up to 8 Weeks)|All subject population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Participants|||Number
2626568|NCT01899053|Primary|Peak to Trough Ratio for TAK-228 in DDI Expansion Cohort||Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 10 predose and at multiple timepoints (up to 24 hours) postdose|PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.|||ratio||Standard Deviation|Mean
2627242|NCT01892267|Secondary|Intervention Time|Time required from introduction of the upper endoscope until placement of the feeding tube.|Intra-procedural||||minute||Standard Deviation|Mean
2626531|NCT01899768|Secondary|Mean Body Temperature at the Indicated Time Points in Parts A, B and C|Body temperature measurements were obtained at1 hr post-dose 2 FA and SA in Part A and each administration in Parts B, and C. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A.|1 hr post the second dose administered in Part A and 1 hr post each dose administered in Parts B and C (up to 8 Weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Degree Celsius||Standard Deviation|Mean
2626532|NCT01899768|Secondary|Mean Heart Rate at the Indicated Time Points in Parts A, B and C|Heart rate measurements were obtained at following time points: pre-dose, 5 min, 15 min (only in Part A), 30 min, and 1 hr after FA and SA in Part A and each dose administration in Parts B and C. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. Pre-Dose is the average of the triplicate readings taken at the pre-dose assessment.|Pre-dose, 5 min, 15 min (only in Part A), 30 min, and 1 hr after each dose administered in Parts A, B and C (up to 8 weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Beats per minute||Standard Deviation|Mean
2626533|NCT01899768|Secondary|Mean Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points in Parts A, B and C|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements were obtained at following time points: pre-dose, 5 minutes (min), 15 min (only in Part A), 30 min, and 1 hr after first administration (FA) and second administration (SA) in Part A and each dose administration of Parts B and C. FA is the first of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. SA is the second of the two doses of GSK2339345 or placebo administered at any of the three visits in Part A. Pre-Dose is the average (avg) of the triplicate readings taken at the pre-dose assessment.|Pre-dose, 5 min, 15 min (only in Part A), 30 min, and 1 hr post each dose administered in Parts A, B and C (up to 8 weeks)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2626534|NCT01899768|Secondary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.|From the start of study treatment and until the follow-up contact (up to 8 Weeks)|All Subjects Population|||participants|||Number
2626535|NCT01899768|Primary|Total Cough Count Excluding Transient Coughs Over 8 Hours at Visits 1, 2 and 3 (Part A)|Total cough count (8 hr of recording) was conducted at Visits 1, 2 and 3. Coughs were counted by a cough monitor fitted to the participants for 8 hr post Dose 1. The cough count was calculated as the sum of two four hour cough count totals, with the first 4-hrs starting from the time of the first dose and the second four hours starting at the time of the second dose. The cough counts were sum-up by the treatments received by the participants. Transient cough was the total number of coughs experienced in the two mins from the start of the first inhalation of a dose. Number of coughs excluding transient cough in 8 hr period was loge transformed and used for the analysis. Values were imputed pro-rata if 8 hr epoch was less than 8 hr. Mean of the total cough counts excluding transient cough recorded post dose of every treatment i.e. placebo or GSK2339345 1000 mcg was reported.|Up to 8 hours post-dose at Visits 1, 2 and 3 (Part A)|All Subjects Population. Only participants with at least one 8 hr cough count were analyzed.|||Cough count||Standard Error|Geometric Mean
2626536|NCT01899768|Primary|Total Cough Count Over 8 Hours at Visits 1, 2 and 3 (Part A)|Total cough count (8 hours [hr] of recording) was conducted at Visits 1, 2 and 3. Coughs were counted by a cough monitor fitted to the participants for 8 hr post Dose 1. The cough count was calculated as the sum of two four hour cough count totals, with the first four hours starting from the time of the first dose and the second four hours starting at the time of the second dose. The cough counts were sum-up by the treatments received by the participants. Number of coughs in 8 hr period was loge transformed and used for the analysis. Values were imputed pro-rata if 8 hr epoch was less than 8 hr. Mean of the total cough counts recorded post dose of every treatment i.e. placebo or GSK2339345 1000mcg was reported.|Up to 8 hours post-dose at Visits 1, 2 and 3 (Part A)|All Subjects Population comprised of all participants who receive at least one dose of study medication. Only participants with at least one 8 hr cough count were analyzed.|||cough count||Standard Error|Geometric Mean
2626537|NCT01899742|Secondary|Change From BL in FEV1 at 3 Hours Postdose on Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in 1 second. FEV1 assessments taken on 0 to 3 hour on Day 84 (pre-dose, 5 minutes (min), 15 min, 30 min, 1 hour, and 3 hour post-dose). Pre-dose was the reading obtained at 24 hours after the previous day's dose (Day 83 dose). BL is defined as mean of the values measured 23 hour and 24 hour after dosing prior to Day 1 (ie. after the last OL tiotropium dosing and prior to the randomized dose). Change from BL is defined as the post-BL value minus the BL value. Analysis performed using mixed model repeated measures with covariates of treatment, BL FEV1, center group, 24 hour subset flag, time, time by treatment interaction and time by BL interaction. Only those participants with data available at the specified time point were included in the analysis.|Baseline and Day 84|ITT Population|||Liters||Standard Error|Least Squares Mean
2630546|NCT01853371|Primary|Systolic Blood Pressure After 4 Weeks||1 month||||mmHg||Standard Deviation|Mean
2626538|NCT01899742|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Visit 8)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in 1 second. BL was the mean of the values measured 23 hour and 24 hour after dosing prior to Day 1 (ie. after the last open label [OL] tiotropium dosing and prior to the randomized dose). Change from BL is defined as the post-BL value minus the BL value. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 84 (at Week 12 + 1 day). Analysis performed using a mixed repeated measures model (MMRM) with covariates of treatment, BL, center group, 24 hour subset flag, Day, Day by BL and Day by treatment interactions. ITT Population is defined as participants who received at least one dose of randomized study medication in the treatment period. Only those participants with data available at the specified time point were included in the analysis.|Baseline (BL) and Day 85|ITT Population|||Liters||Standard Error|Least Squares Mean
2626539|NCT01899729|Primary|Safety and Tolerability|Evaluation of safety and tolerability of different dose levels of IMO-8400 compared to placebo administered for 12 weeks to patients with moderate to severe plaque psoriasis.|19 weeks (12 weeks on treatment + 7 week follow up)|Safety population|||Participants|||Count of Participants
2626540|NCT01899677|Primary|Interferon Levels at 28+/-2 Days||28+/-2 days||||pg/ml||Inter-Quartile Range|Median
2626541|NCT01899677|Primary|Interferon Levels at 14+/-2 Days||14+/-2 days||||pg/ml||Inter-Quartile Range|Median
2626542|NCT01899677|Primary|Interferon Levels at 0+2 Days||0+2 days||||pg/ml||Inter-Quartile Range|Median
2626543|NCT01899677|Primary|Interleukin 17A Levels at 28+/-2 Days||28+/-2 days||||pg/ml||Inter-Quartile Range|Median
2626544|NCT01899677|Primary|Interleukin 17A Levels at 14+/- 2 Days||14+/- 2 days||||pg/ml||Inter-Quartile Range|Median
2626545|NCT01899677|Primary|Interleukin 17A Levels at 0+2 Days||0+2 days||||pg/ml||Inter-Quartile Range|Median
2626546|NCT01899677|Primary|Interleukin 10 Levels at 28+/-2 Days||28+/-2 days||||pg/ml||Inter-Quartile Range|Median
2626547|NCT01899677|Primary|Interleukin 10 Levels at 14+/- 2 Days||14+/- 2 days||||pg/ml||Inter-Quartile Range|Median
2626548|NCT01899677|Primary|Interleukin 10 Levels at 0+2 Days||0+2 days||||pg/ml||Inter-Quartile Range|Median
2626549|NCT01899677|Primary|Interleukin 5 Levels at 28+/-2 Day||28+/-2 day||||pg/ml||Inter-Quartile Range|Mean
2626550|NCT01899677|Primary|Interleukin 5 Levels on 14+/-2 Day||14+/-2 day||||pg/ml||Inter-Quartile Range|Median
2626551|NCT01899677|Primary|Interleukin 5 Serum Cytokine Level on 0+2 Day||0+2 day||||pg/ml||Inter-Quartile Range|Median
2626552|NCT01899261|Secondary|TTLP|Estimated by the Kaplan-Meier method.|Time from study entry to radiographic local progression based on RECIST, assessed up to 2 years|||||||
2626553|NCT01899261|Secondary|Response Rate Defined as Proportion of Patients Achieving a Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria in Solid Tumors (RECIST)||Up to 6 months after completion of SBRT|||||||
2626554|NCT01899261|Secondary|OS|Estimated by the Kaplan-Meier method.|Time from study entry to death from any cause, assessed up to 2 years|||||||
2626555|NCT01899261|Secondary|CSS|Competing risk analysis will be performed.|Time from study entry to death from HCC progression, assessed up to 2 years|||||||
2626556|NCT01899261|Primary|Severe Treatment-related Toxicity|The percentage of patients who have severe treatment-related toxicity will be computed, along with exact 95% confidence intervals. Severe toxicity will be defined as grade 4 or 5 hepatic toxicity, thrombocytopenia, or gastrointestinal toxicity, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Within 3 months of SBRT||||Participants|||Count of Participants
2626557|NCT01899144|Secondary|Participants With Treatment-Emergent Adverse Events|"Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator as mild (no limitation of usual activities), moderate, or severe (inability to carry out usual activities).~Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes."|Day 1 up to Day 35|The safety population included all randomized patients who received at least 1 dose of randomized study medication. In this population, treatment was assigned based upon the treatment patients actually receive regardless of the treatment to which they were randomized.|||participants|||Number
2626558|NCT01899144|Secondary|Baseline-Adjusted Area-Under-The- Forced Expiratory Volume In 1 Second (FEV1) Versus Time Curve Over 6 Hours Post-Dose (FEV1 AUC0-6)|FEV1 AUC0-6 was calculated using the linear trapezoidal rule, and baseline adjustment was made by subtracting the average of the 2 pre-dose FEV1 values from each post-dose FEV1 determination.|Treatment visits 1-5 (approximately days 1, 6, 11, 16, and 21); -35 and -5 minutes prior to dosing and 5 (±2), 15 (±5), 30 (±5), 45 (±5), 60 (±5), 120 (±5), 180 (±5), 240 (±5), 300 (±5), and 360 (±5) minutes after the completion of study drug administrati|Full analysis set|||L*hour||Standard Error|Mean
2626569|NCT01899053|Primary|CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-228 in DDI Expansion Cohort||Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 10 predose and at multiple timepoints (up to 24 hours) postdose|PK DDI-evaluable population consisted of all participants from Expansion Phase with sufficient dosing and concentration-time PK data to reliably estimate PK parameters for statistical analyses of effect of TAK-228 on TAK-117 PK and effect of TAK-117 on TAK-228 PK. Number analyzed is number of participants with evaluable data at given time-point.|||L/hour||Standard Deviation|Mean
2626766|NCT01897402|Primary|Seroresponse (Percent Seroconversion).|Rise in antibody titers in serum at 4 weeks after vaccination, compared to baseline titer for meningococcal serogroups A, C, Y, and W-135. Serum Bactericidal Assay with human complement: Antibody titer ≥1:8 for subjects with titer <1:8 at baseline or a 4-fold rise in antibody levels.|Week 4 after injection|Per Protocol Population|||percentage of per protocol participants||95% Confidence Interval|Number
2626559|NCT01899144|Primary|Baseline-Adjusted Area-Under-The-Percent-Predicted Forced Expiratory Volume In 1 Second (FEV1) Versus Time Curve Over 6 Hours Post-Dose|"Percent predicted FEV1: measured FEV1 as a percent of the predicted values for the patients of similar characteristics. Predicted FEV1 values were computed and adjusted for age, height, and gender for patients aged 4-5 years (Eigen et al 2001) and for patients aged 6-11 years (Quanjer et al 1995) using ATS/European Thoracic Society (ERS) criteria applicable to pediatric patients (ATS/ERS 2007).~The percent predicted FEV1 (PPFEV1) area under the curve (AUC)0-6 was calculated using the linear trapezoidal rule, and baseline adjustment was made by subtracting the average of the 2 pre-dose PPFEV1 values from each post-dose PPFEV1 determination."|Treatment visits 1-5 (approximately days 1, 6, 11, 16, and 21); -35 and -5 minutes prior to dosing and 5 (±2), 15 (±5), 30 (±5), 45 (±5), 60 (±5), 120 (±5), 180 (±5), 240 (±5), 300 (±5), and 360 (±5) minutes after the completion of study drug administrati|Full analysis set (FAS) included all participants in the ITT population who received at least 1 dose of study medication, had a baseline assessment, and had at least 1 post baseline assessment.|||%predicted FEV1*hour||Standard Error|Mean
2626560|NCT01899053|Secondary|Duration of Response (DOR)|The DOR is defined as the time from the date of first documented response of CR/PR to the first documented progressive disease (PD), or censored at the last response assessment date that is SD or better for a participant that has not progressed. CR was defined as the disappearance of all target lesions and for non-target lesions, the disappearance of all non-target lesions and normalization of tumor marker level. PR was defined of at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD and for non-target lesions.|Baseline, Days 22 up to Day 28 of Cycle and every even-numbered cycle until disease progression or EOS (Up to approximately 68 weeks)|Safety population consisted of all enrolled participants who received at least 1 dose of any study drug. Data for this outcome measure is reported for the participants with objective response available.|||days||Full Range|Median
2626561|NCT01899053|Secondary|Objective Response Rate (ORR) Based on Investigator's Assessment According to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|ORR defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 for target lesions and assessed by CT or MRI. CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter (LD) of target lesions. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum LD since the treatment started.|Baseline, Days 22 up to Day 28 of Cycle and every even-numbered cycle until disease progression or EOS (Up to approximately 68 weeks)|Safety population consisted of all enrolled participants who received at least 1 dose of any study drug.|||percentage of participants|||Number
2626562|NCT01899053|Primary|Peak to Trough Ratio for TAK-117 in DDI Expansion Cohort||Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 17 predose and at multiple timepoints (up to 24 hours) postdose|PK DDI-evaluable population consisted of all participants from Expansion Phase with sufficient dosing and concentration-time PK data to reliably estimate PK parameters for statistical analyses of effect of TAK-228 on TAK-117 PK and effect of TAK-117 on TAK-228 PK. Number analyzed is number of participants with evaluable data at given time-point.|||ratio||Standard Deviation|Mean
2626563|NCT01899053|Primary|CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-117 in DDI Expansion Cohort||Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 17 predose and at multiple timepoints (up to 24 hours) postdose|PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.|||L/hour||Standard Deviation|Mean
2626564|NCT01899053|Primary|Terminal Phase Elimination Half-life (T1/2) for TAK-117 in DDI Expansion Cohort||Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 17 predose and at multiple timepoints (up to 24 hours) postdose|PK DDI-evaluable population consisted of all participants from Expansion Phase with sufficient dosing and concentration-time PK data to reliably estimate PK parameters for statistical analyses of effect of TAK-228 on TAK-117 PK and effect of TAK-117 on TAK-228 PK. Number analyzed is number of participants with evaluable data at given time-point.|||hour||Standard Deviation|Mean
2626565|NCT01899053|Primary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Observed Quantifiable Concentration for TAK-117 in DDI Expansion Cohort||Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 17 predose and at multiple timepoints (up to 24 hours) postdose|PK DDI-evaluable population consisted of all participants from Expansion Phase with sufficient dosing and concentration-time PK data to reliably estimate PK parameters for statistical analyses of effect of TAK-228 on TAK-117 PK and effect of TAK-117 on TAK-228 PK. Number analyzed is number of participants with evaluable data at given time-point.|||ng*hr/mL||Standard Deviation|Mean
2626566|NCT01899053|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-117 in DDI Expansion Cohort||Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 17 predose and at multiple timepoints (up to 24 hours) postdose|PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.|||ng/mL||Standard Deviation|Mean
2626567|NCT01899053|Primary|Tmax: Time to Reach the Maximum Observed Plasma Concentration for TAK-117 in DDI Expansion Cohort||Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 17 predose and at multiple timepoints (up to 24 hours) postdose|PK DDI-evaluable population consisted of all participants from Expansion Phase with sufficient dosing and concentration-time PK data to reliably estimate PK parameters for statistical analyses of effect of TAK-228 on TAK-117 PK and effect of TAK-117 on TAK-228 PK. Number analyzed is number of participants with evaluable data at given time-point.|||hour||Full Range|Median
2626788|NCT01897077|Secondary|The Rate of Medication Use With Therapy|For peanut allergic subjects only.|18 months|No participants were analyzed for this secondary outcome because no data for the outcome was collected due to early termination of the study||||||
2635248|NCT01806506|Secondary|Albumin Level||12 months|||||||
2626570|NCT01899053|Primary|Terminal Phase Elimination Half-life (T1/2) for TAK-228 in DDI Expansion Cohort||Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 10 predose and at multiple timepoints (up to 24 hours) postdose|PK DDI-evaluable population consisted of all participants from Expansion Phase with sufficient dosing and concentration-time PK data to reliably estimate PK parameters for statistical analyses of effect of TAK-228 on TAK-117 PK and effect of TAK-117 on TAK-228 PK. Number analyzed is number of participants with evaluable data at given time-point.|||hour||Standard Deviation|Mean
2626571|NCT01899053|Primary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Observed Quantifiable Concentration for TAK-228 in DDI Expansion Cohort||Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 10 predose and at multiple timepoints (up to 24 hours) postdose|PK DDI-evaluable population consisted of all participants from Expansion Phase with sufficient dosing and concentration-time PK data to reliably estimate PK parameters for statistical analyses of effect of TAK-228 on TAK-117 PK and effect of TAK-117 on TAK-228 PK. Number analyzed is number of participants with evaluable data at given time-point.|||ng*hr/mL||Standard Deviation|Mean
2626572|NCT01899053|Primary|Cmax: Maximum Observed Plasma Concentration for TAK-228 in DDI Expansion Cohort||Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 10 predose and at multiple timepoints (up to 24 hours) postdose|PK DDI-evaluable population consisted of all participants from Expansion Phase with sufficient dosing and concentration-time PK data to reliably estimate PK parameters for statistical analyses of effect of TAK-228 on TAK-117 PK and effect of TAK-117 on TAK-228 PK. Number analyzed is number of participants with evaluable data at given time-point.|||ng/mL||Standard Deviation|Mean
2626573|NCT01899053|Primary|Tmax: Time to Reach the Maximum Observed Plasma Concentration for TAK-228 in DDI Expansion Cohort||Cycle 1, Day 3 predose and at multiple timepoints (up to 8 hours) postdose; Cycle 1, Day 10 predose and at multiple timepoints (up to 24 hours) postdose|PK DDI-evaluable population consisted of all participants from Expansion Phase with sufficient dosing and concentration-time PK data to reliably estimate PK parameters for statistical analyses of effect of TAK-228 on TAK-117 PK and effect of TAK-117 on TAK-228 PK. Number analyzed is number of participants with evaluable data at given time-point.|||hour||Full Range|Median
2626574|NCT01899053|Primary|Peak to Trough Ratio After Single-dose and Multiple-dose of TAK-117 in Dose Escalation Cohort||Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose|PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.|||ratio||Standard Deviation|Mean
2626575|NCT01899053|Primary|RAC: Accumulation Ratio for TAK-117 in the Dose Escalation Cohort|Accumulation ratio was based on AUC(0-24) between Cycle 1 Day 24 and Cycle 1 Day 1 (e.g. AUC(0-24) [Cycle 1 Day 24]/ AUC(0-24) [Cycle1 Day 1].|Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose|PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Overall number of participants analyzed is the number of participants with evaluable data at both Days 1 and 24.|||ratio||Standard Deviation|Mean
2626576|NCT01899053|Primary|CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Concentration After Single-dose and Multiple-dose of TAK-117 in Dose Escalation Cohort||Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose|PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.|||L/hr||Standard Deviation|Mean
2626577|NCT01899053|Primary|Terminal Phase Elimination Half-life (T1/2) After Single-dose and Multiple-dose of TAK-117 in Dose Escalation Cohort||Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose|PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.|||hour||Standard Deviation|Mean
2626578|NCT01899053|Primary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Observed Quantifiable Concentration After Single-dose and Multiple-dose of TAK-117 in Dose Escalation Cohort||Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose|PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.|||ng*hr/mL||Standard Deviation|Mean
2626579|NCT01899053|Primary|Cmax: Maximum Observed Plasma Concentration After Single-dose and Multiple-dose of TAK-117 in the Dose Escalation Cohort||Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose|PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.|||ng/mL||Standard Deviation|Mean
2626580|NCT01899053|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) After Single-dose and Multiple-dose of TAK-117 in the Dose Escalation Cohort||Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose|PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.|||hour||Full Range|Median
2626581|NCT01899053|Primary|Peak to Trough Ratio for TAK-228 After Single-dose and Multiple-dose of TAK-228 in the Dose Escalation Cohort||Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose|PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.|||ratio||Standard Deviation|Mean
2627243|NCT01892267|Secondary|Technical Success|Success of tube placement in the desired location as determined endoscopically.|Intra-procedural||||procedure|||Number
2635249|NCT01806506|Secondary|INR||12 months|||||||
2626582|NCT01899053|Primary|RAC: Accumulation Ratio for TAK-228 in the Dose Escalation Cohort|Accumulation ratio was based on AUC(0-24) between Cycle 1 Day 24 and Cycle 1 Day 1 (e.g. AUC(0-24) [Cycle 1 Day 24]/ AUC(0-24) [Cycle1 Day 1].|Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose|PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Overall number of participants analyzed is the number of participants with evaluable data at both Days 1 and 24.|||ratio||Standard Deviation|Mean
2626583|NCT01899053|Primary|CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Concentration After Single-dose and Multiple-dose of TAK-228 in the Dose Escalation Cohort||Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose|PK population consisted of all participants enrolled during the dose escalation and expansion stage of the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants who were evaluable at each category.|||L/hour||Standard Deviation|Mean
2626584|NCT01899053|Primary|Terminal Phase Elimination Half-life (T1/2) After Single-dose and Multiple-dose of TAK-228 in the Dose Escalation Cohort||Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose|PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.|||hour||Standard Deviation|Mean
2626585|NCT01899053|Primary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Observed Quantifiable Concentration After Single-dose and Multiple-dose of TAK-228 in the Dose Escalation Cohort||Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose|PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.|||ng*hr/mL||Standard Deviation|Mean
2626586|NCT01899053|Primary|Cmax: Maximum Observed Plasma Concentration After Single-dose and Multiple-dose of TAK-228 in the Dose Escalation Cohort||Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose|PK population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.|||ng/mL||Standard Deviation|Mean
2626587|NCT01899053|Primary|Tmax: Time to Reach the Maximum Observed Plasma Concentration After Single-dose and Multiple-dose of TAK-228 in the Dose Escalation Cohort||Cycle 1: Days 1 and 24 predose and at multiple timepoints (up to 24 hours) postdose|Pharmacokinetic (PK) population consisted of all participants enrolled in the study who received at least 1 dose of TAK-228 and TAK-117 and had sufficient concentration-time data to calculate 1 or more PK parameters. Number analyzed is the number of participants with evaluable data at the given time-point.|||hour||Full Range|Median
2626588|NCT01899053|Primary|Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Event (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above-mentioned criteria.|From Baseline to 30 days after the last dose of study drug (Up to approximately 68 weeks)|Safety population consisted of all enrolled participants who received at least 1 dose of any study drug.|||Participants|||Count of Participants
2626589|NCT01898884|Secondary|Renal Clearance at Steady State (CLR,ss) of VP 20629 for Multiple Dose Groups|The CLR,ss is the renal clearance of the drug, calculated as Ae/AUC(0-infinity) on Day 8.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||liter per hour||Standard Deviation|Mean
2626590|NCT01898884|Secondary|Percentage of Drug Excreted in Urine at Steady-State (Ae%,ss) of VP 20629 for Multiple Dose Groups|The Ae%,ss is the percentage of drug dose excreted into the urine calculated as (Ae divided by dose)∗100.|0-4, 4-8, 8-16, 16-24, 24-36, and 36-48 hours postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||percentage of dose||Standard Deviation|Mean
2626591|NCT01898884|Secondary|Cumulative Amount Excreted Into the Urine at Steady State (Ae,ss) of Unchanged VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Ae,ss is the amount of drug excreted in urine. It is calculated by multiplying the urinary volume with the urinary drug concentration.|0-4, 4-8, 8-16, 16-24, 24-36, and 36-48 hours postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||microgram||Standard Deviation|Mean
2626592|NCT01898884|Secondary|Elimination Rate Constant (Lambda[z]) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||per hour||Standard Deviation|Mean
2626605|NCT01898884|Secondary|Percentage of Drug Excreted in Urine (Ae%) of VP 20629 for Single Dose Groups|The Ae% is the percentage of drug dose excreted into the urine calculated as (Ae divided by dose)∗100.|-4, 4-8, 8-16, 16-24, 24-36 and 36-48 hours postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||percentage of dose||Standard Deviation|Mean
2635250|NCT01806506|Secondary|ALT Level||12 months|||||||
2626593|NCT01898884|Secondary|Total Body Drug Clearance at Steady State (CLss/F) of VP 20629 for Multiple Dose Groups|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||liter per hour||Standard Deviation|Mean
2626594|NCT01898884|Secondary|Volume of Distribution (Vz/F) of VP 20629 for Multiple Dose Groups|The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||liter||Standard Deviation|Mean
2626595|NCT01898884|Secondary|Terminal Plasma Half-Life (t1/2) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||hour||Standard Deviation|Mean
2626596|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUCt) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The AUCtau is the measure of the plasma drug concentration from time zero to time t.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."|||h*ng/mL||Standard Deviation|Mean
2626597|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC[0-8]) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The AUC(0-8) is the area under the plasma concentration-time curve from time zero to 8 hours postdose.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6 and 8 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, n is number of participants analyzed for this outcome measure at given time points."|||h*ng/mL||Standard Deviation|Mean
2626598|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The AUCss is the area under the plasma concentration time curve observed during a dosing at steady state.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 8 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||h*ng/ml||Standard Deviation|Mean
2626599|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The AUC is the area under the plasma concentration-time curve observed.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||h*ng/ml||Standard Deviation|Mean
2626600|NCT01898884|Secondary|Time of Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Tmax,ss is the time to reach maximum observed plasma concentration at steady state of multiple dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."|||hour||Standard Deviation|Mean
2626601|NCT01898884|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Tmax is the time to reach maximum observed plasma concentration of multiple dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 24 and 72 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."|||hour||Standard Deviation|Mean
2626602|NCT01898884|Secondary|Maximum Observed Serum Concentration at Steady State (Cmax,ss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Cmax,ss is the maximum observed plasma concentration at steady state.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."|||ng/mL||Standard Deviation|Mean
2626603|NCT01898884|Secondary|Maximum Observed Serum Concentration (Cmax) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups|The Cmax is the maximum observed plasma concentration of Multiple Dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 24 and 72 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2626604|NCT01898884|Secondary|Renal Clearance (CLR) of VP 20629 for Single Dose Groups|The CLR is the renal clearance of the drug, calculated as Ae/AUC(0-infinity) on Day 1 or Ae(0-24)/AUC(0-24) on Day 1.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||liter per hour||Standard Deviation|Mean
2631181|NCT01846728|Secondary|Fat Mass|Amount of body fat (in kg)|Baseline and after 3 months of suppression||||kg||Standard Deviation|Mean
2626606|NCT01898884|Secondary|Cumulative Amount Excreted Into the Urine (Ae) for Unchanged VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The Ae is the amount of drug excreted in urine. It is calculated by multiplying the urinary volume with the urinary drug concentration.|0-4, 4-8, 8-16, 16-24, 24-36 and 36-48 hours postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N is number of participants analyzed for this outcome measure."|||microgram (mcg)||Standard Deviation|Mean
2626607|NCT01898884|Secondary|Elimination Rate Constant (Lambda[z]) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.|||per hour||Standard Deviation|Mean
2626608|NCT01898884|Secondary|Total Body Drug Clearance (CL/F) of VP 20629 for Single Dose Groups|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.|||liter per hour||Standard Deviation|Mean
2626609|NCT01898884|Secondary|Volume of Distribution (Vz/F) of VP 20629 for Single Dose Groups|The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.|||Liter||Standard Deviation|Mean
2626610|NCT01898884|Secondary|Terminal Plasma Half-Life (t1/2) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.|||hour||Full Range|Median
2626611|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve to the Last Measurable Plasma Concentration (AUCt) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The AUCt is the measure of the plasma drug concentration from time zero to time t.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."|||h*ng/mL||Standard Deviation|Mean
2626612|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC[0-8]) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The AUC(0-8) is the area under the plasma concentration-time curve from time zero to 8 hours postdose.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 8 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."|||h*ng/mL||Standard Deviation|Mean
2626613|NCT01898884|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The AUC is the area under the plasma concentration-time curve observed.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.|||hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
2626614|NCT01898884|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The Tmax is the time to reach maximum observed plasma concentration of single dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."|||hour||Standard Deviation|Mean
2626615|NCT01898884|Secondary|Maximum Observed Serum Concentration (Cmax) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups|The Cmax is the maximum observed plasma concentration of single dose of VP 20629 and VP 20631.|Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1|"The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, N (Number of participants analyzed) and n are number of participants analyzed for this outcome measure and for the specified compound, respectively."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2626616|NCT01898884|Primary|Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)|ECG included PR interval, QRS interval, QTcB interval, QTcF interval were considered as clinically significant ECG abnormalities.|From Start of Study Treatment up to Day 19|The ITT-S set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.|||participants|||Number
2626617|NCT01898884|Primary|Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included systolic blood pressure, diastolic blood pressure, heart rate, and temperature. Vital signs abnormalities reported as TEAEs were reported.|From Start of Study Treatment up to Day 19|The ITT-S set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.|||participants|||Number
2626648|NCT01898286|Primary|Hypoglycemic Events|The number of hypoglycemic events recorded by each patient over the course of the study.|At Early Termination Visit, Up to 25 Months|Patients with hypoglycemic event data at the time of their early termination visit. This population is smaller than the population numbers in the patient flow categories because not all patients were willing to provide information on hypoglycemic events at early termination.|||hypoglycemic events||Standard Deviation|Mean
2626618|NCT01898884|Primary|Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 7 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with Grade 3 or higher treatment-emergent adverse events for laboratory abnormalities were reported as clinically relevant laboratory changes.|From Start of Study Treatment up to Day 19|The ITT-S set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.|||participants|||Number
2626619|NCT01898884|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAEs), defined as all AEs that start during study drug treatment (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during study drug treatment (and up to 7 days after the last dose of study drug).|From Start of Study Treatment up to Day 19|The ITT-safety (ITT-S) set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.|||participants|||Number
2626620|NCT01898806|Secondary|Number of Adverse Events|Incidence and severity of adverse events (AEs) including the presence and degree of skin atrophy, as well as incidence of treatment-emergent laboratory abnormalities.|48 weeks||||adverse events|||Number
2626621|NCT01898806|Primary|Proportion of Responders|Comparison of the proportion of responders in each group, with response defined as 50% change (% change NOT absolute change) in SALT score from baseline (50% regrowth at week 24).|Up to 48 weeks|Data was not collected for this outcome since enrollment was incomplete and therefore could not be analyzed. The only information available is demographics data that was submitted to the IRB for the whole group, and not stratified per arm.||||||
2626622|NCT01898611|Secondary|Change in Frailty Status|According to the Fried frailty criteria: Weight loss, exhaustion, low physical activity, slow walking speed, weakness, range 0 to 5, higher score indicates more frailty|Baseline to 12 weeks.||||units on a scale||Full Range|Mean
2626623|NCT01898611|Secondary|Change in Quality of Life|Quality of life as assessed by short form 36 (SF-36), higher score indicates better quality of life, scale is 0-100 points|Baseline to 12 weeks.||||score on a scale||Standard Deviation|Mean
2626624|NCT01898611|Secondary|Change in Food Intake|Change in food intake by 3-day food intake record|Baseline to 12 weeks.||||kcal/day||Standard Deviation|Mean
2626625|NCT01898611|Secondary|Change in Muscle Strength|One repetition max bench press|Baseline to 12 weeks||||kg||Standard Deviation|Mean
2626626|NCT01898611|Secondary|Change in Lean Body Mass|Total lean body mass by dual energy x-ray absorptiometry|Baseline to 12 weeks||||kg||Standard Deviation|Mean
2626627|NCT01898611|Secondary|Change in Weight|Change in weight from baseline to 12 weeks|Baseline to twelve weeks||||kg||Standard Deviation|Mean
2626628|NCT01898611|Primary|Treatment-associated Adverse Events|Treatment-associated emergent adverse events, including clinically meaningful changes in laboratory measurements (IGF-1, HbA1c, fasting blood glucose, fasting insulin).|Twelve weeks||||events|||Number
2626629|NCT01898611|Primary|Change in the Short Physical Performance Battery (SPPB)|The SPPB includes three components: gait speed on a 15-foot walk, standing balance testing, and time to rise from a chair 5 times. Each test is rated on a five-level categorical score, with 0 representing inability to complete the test and 4 representing the highest level of performance, and summed to create a score ranging from 0 to 12.|Baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
2626630|NCT01898598|Secondary|Percentage of Participants With BCC Recurrence||Baseline, 12, 24, and 52 weeks post MMS Visit (MMS Visit = Week 12-14)|This outcome was based on the cumulative data post MMS Visit and due to early study termination with very few enrolled participants, complete data for this outcome measure could not be collected.||||||
2626631|NCT01898598|Secondary|Percentage of Participants With Skip Area|Skip area was defined as the presence of non-contiguous residual tumor at the MMS visit, as determined by an independent dermatopathologist. MMS visit occurred within 2 weeks of the last study treatment.|MMS visit (Week 12-14)|ITT population.|||Percentage of participants||95% Confidence Interval|Number
2626632|NCT01898598|Secondary|Percentage of Participants With Clinical Response|Clinical response was defined as a complete response (CR) or partial response (PR) at the post-treatment MMS excision. CR was defined as no histological evidence of BCC. PR was defined as a reduction of at least 50 % in the expected surgical defect area with histologic evidence of residual BCC. MMS visit was defined the visit that occurred within 2 weeks of the last study treatment.|MMS visit (Week 12-14)|ITT population.|||Percentage of participants||95% Confidence Interval|Number
2626633|NCT01898598|Secondary|Percentage Change in Target BCC Actual Tumor-Free Margin Excision Area at MMS Visit|Percent change in target BCC actual tumor-free margin excision area was defined as = (expected surgical defect area pre-treatment - actual tumor-free margin excision area at MMS visit) / expected surgical defect area pre-treatment) * 100%. The actual tumor-free margin excision area (includes 2 millimeters [mm] margin) was measured during MMS. The area was photographed and traced on the digital photograph then calculated by computer-aided planimetry. MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment.|Baseline, MMS visit (Week 12-14)|ITT. Here 'Number of participants analyzed' represents participants evaluable for this outcome measure.|||Percent change in margin excision area||Standard Deviation|Mean
2626789|NCT01897077|Secondary|Number of Participants With Serious and Non-serious Adverse Effects With Therapy||18 months|No participants were analyzed for this secondary outcome in the peanut allergic group because data was not collected due to early termination of the study|||Participants|||Count of Participants
2635251|NCT01806506|Secondary|AST Level||12 months|||||||
2626634|NCT01898598|Secondary|Actual Change in Target BCC Expected Surgical Defect Area at MMS Visit|Actual change was defined as (baseline expected surgical defect area - expected surgical defect area at MMS visit). MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment. Expected surgical defect area was manually outlined on a digital photograph and measured by a computer (computer aided planimetry).|Baseline, MSS Visit (Week 12-14)|ITT Population. Here 'Number of participants analyzed' represents participants evaluable for this outcome measure.|||Square millimeter (mm^2)||Standard Deviation|Mean
2626635|NCT01898598|Primary|Percent Change in Target Basal Cell Carcinoma (BCC) Expected Surgical Defect Area at Mohs Micrographic Surgery (MMS) Visit|The percent change in target BCC expected surgical defect area was defined as ([baseline expected surgical defect area − expected surgical defect area at MMS visit]/ baseline expected surgical defect area) × 100 percent (%) where expected surgical defect area was manually outlined on a digital photograph and measured by a computer (computer aided planimetry). MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment.|Baseline, MMS visit (Week 12-14)|ITT population. Here 'Number of participants analyzed' represents participants evaluable for this outcome measure.|||Percent change in surgical defect area||Standard Deviation|Mean
2626636|NCT01898442|Secondary|Pharmacokinetic Profiles of Ticagrelor (AUC0-t)|Pharmacokinetic assessments included determination of plasma concentration of ticagrelor. Time for the maximum plasma concentration (Tmax), maximum observed plasma concentration (Cmax) and the area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC0-t) were calculated.|24 hours||||ng*hr/mL||Full Range|Geometric Mean
2626637|NCT01898442|Secondary|Pharmacokinetic Profiles of Ticagrelor (Cmax)|Pharmacokinetic assessments included determination of plasma concentration of ticagrelor. Time for the maximum plasma concentration (Tmax), maximum observed plasma concentration (Cmax) and the area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC0-t) were calculated.|24 hours||||ng/mL||Full Range|Geometric Mean
2626638|NCT01898442|Secondary|Pharmacokinetic Profiles of Ticagrelor (Tmax)|Pharmacokinetic assessments included determination of plasma concentration of ticagrelor. Time for the maximum plasma concentration (Tmax), maximum observed plasma concentration (Cmax) and the area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC0-t) were calculated.|24 hours||||hours||Full Range|Geometric Mean
2626639|NCT01898442|Secondary|Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP) at All Time Points|Secondary outcomes included the comparison of the platelet reactivity index (PRI) determined by vasodilator-stimulated phosphoprotein (VASP) at 30 min and 1, 2, 4, 8, 24 hours after ticagrelor loading dose administration|30 min and 1, 2, 4, 8, 24 hours||||PRI||Standard Error|Least Squares Mean
2626640|NCT01898442|Secondary|Platelet Reactivity by VerifyNow P2Y12 at Other Time Points|Secondary outcomes included the comparison of the P2Y12 reaction units (PRU) determined by VerifyNow P2Y12 at 30 min and 2, 4, 8, 24 hours after ticagrelor loading dose administration|30 min and 2, 4, 8, 24 hours||||PRU||Standard Error|Least Squares Mean
2626641|NCT01898442|Primary|Platelet Reactivity by VerifyNow P2Y12|The primary end-point of the study was the comparison of the P2Y12 reaction units (PRU) determined by VerifyNow P2Y12 at 1 hour after administration|1 hour||||PRU||Standard Error|Least Squares Mean
2626642|NCT01898429|Primary|Comparison of 12 Weeks of Left Unilateral DBS vs. 12 Weeks Right Unilateral DBS on Change in 17-item Hamilton Depression Rating Scale (HDRS-17)|Baseline HDRS-17 is defined as the average of 4 weekly HDRS-17 in the 4 weeks leading up to surgery. Change in HDRS-17 after 12 weeks of left-sided stimulation (compared to baseline) will be compared to change in HDRS-17 after 12 weeks of right-sided stimulation (compared to baseline). The scale ranges from 0-48 with higher scored indicating more severe depression. A cutoff of 7 or below is considered remission from depression. A decrease of at least 50% from baseline is considered an antidepressant response.|baseline, 12 weeks of phase 1, 12 weeks of phase 2 and 12 weeks of phase 3 (bilateral stimulation)||||units on a scale||Full Range|Mean
2626643|NCT01898403|Primary|Sentinel Lymph Nodes (SLN) Mapping|Sentinel lymph nodes (SLN) will be identified and mapped using indocyanine green (ICG) solution, isosulfan blue (ISB) solution, and TSC lymphoscintigraphy.|Up to 1 year|All participants were evaluated for sentinel lymph nodes (SLN) using Isosulfan Blue (ISB); Indocyanine Green (ICG); and TSC lymphoscintigraphy.|||Sentinel lymph nodes|Sentinel Lymph Nodes||Number
2626644|NCT01898299|Primary|Severity of Refractory Auditory Hallucinations|Total score: Auditory hallucinations as determined by Auditory Hallucinations Rating Scale (AHRS). This is a seven item scale rating auditory hallucinations. Total score ranges from 1 to 41, with higher scores more severe.|Auditory Hallucination Rating Scale score after one month|Population at one month|||AHRS total score||Standard Deviation|Mean
2626645|NCT01898286|Other Pre-specified|Glycemic Control (Change From Baseline in % HbA1c)||Baseline and Early Termination Visit, Up to 25 Months|All patients with % HbA1c data at baseline and their early termination visit. Only 5 patients were available for this analysis, as not all patients agreed to complete HbA1c testing at the early termination visit.|||% HbA1c||Standard Deviation|Mean
2626646|NCT01898286|Other Pre-specified|Change From Baseline in Daily Insulin Dose, Per kg Body Weight, at Early Termination Visit||Baseline and Early Termination Visit, up to 25 months|All patients with daily insulin dose data at baseline and their early termination visit. Only 11 patients could be included in this analysis, as not all patients provided insulin dose data at their early termination visit.|||IU/kg||Standard Deviation|Mean
2626647|NCT01898286|Secondary|Change From Baseline in Glucagon-stimulated C-peptide AUC at Early Termination Visit|Beta-cell function, measured as change in stimulated C-peptide secretion measured 0, 2, 6, 10 and 20 minutes post administration [area under the curve (AUC), 0-20 minutes] at Baseline and the early termination visit (up to 25 months), during a glucagon stimulation test (GST). Change was calculated for each patient by subtracting the baseline AUC value (defined as the last non-missing assessment prior to first dose in the 1010 study but after the end of study 1001) from the early termination visit AUC.|Baseline and Early Termination Visit, Up to 25 Months|Only 9 patients had sufficient data for this analysis, as many patients declined to undergo the GST at the termination visit.|||nmol*minute/L||Standard Deviation|Mean
2626790|NCT01897077|Secondary|The Proportion of Subjects Who Are Able to Tolerate the Full 10 Gram Peanut Protein Challenge at the Completion of the Study|For peanut allergic subjects only|18 months|No participants were analyzed for this secondary outcome because data was not collected due to early termination of the study||||||
2626649|NCT01898208|Secondary|Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject|Costs were calculated using a standardized inflation-adjusted estimate of costs for each service or procedure performed in constant dollars. This approach adjusts for hospital-billed charges with Medicare Cost Report department-level cost-to-charge ratios. Physician services were proxied with Medicare reimbursement rates based on Current Procedure Terminology (CPT)-4 codes using the Medicare Fee Schedule. We did not include the cost of the stewardship program in the cost analysis, as it is not a billed service. As there was no Medicare reimbursement rate for the rmPCR test at the time of the study, test cost was proxied using the FilmArray respiratory panel. These costs were varied in sensitivity analysis with rmPCR test cost ranging from a 50% decrease to a 300% increase.|Approximately 7 days after positive blood culture and for duration of entire hospitalization|The number of subjects analyzed per arm is different than the number of subjects who completed the study because outpatients and a few subjects without final billing data available were excluded.|||dollars||Standard Deviation|Mean
2626650|NCT01898208|Secondary|Percentage of Subjects With Infectious Disease Consultation Within 72 Hours of Enrollment||Approximately within 72 hours of positive blood culture||||percentage of participants|||Number
2626651|NCT01898208|Secondary|Number of Subjects With Antibiotic-Associated Toxicities/Adverse Events|This included all adverse events that occurred within 2 weeks following enrollment and were documented in the medical record.|Approximately 14 days after positive blood culture||||participants|||Number
2626652|NCT01898208|Secondary|All-cause and Attributable Mortality|If records of death were incomplete, mortality was determined using Accurint (LexisNexis, Philadelphia, PA), an internet research and location service.|30 days after positive blood culture||||participants|||Number
2626653|NCT01898208|Secondary|Length of Entire Hospitalization (Days)||Participants were followed for the duration of hospital stay, approximately 15 days||||days||Inter-Quartile Range|Median
2626654|NCT01898208|Other Pre-specified|Percentage of Patients Who Acquired Clostridium Difficile or Multidrug-resistant Organisms Within 30 Days After Enrollment|Multidrug-resistant organisms included vancomycin-resistant enterococci, methicillin-resistant Staphylococcus aureus, extended-spectrum cephalosporin-resistant Enterobacteriaceae, and Pseudomonas aeruginosa and Acinetobacter species resistant to greater than or equal to 3 antibiotic classes.|Approximately 30 days after positive blood culture||||percentage of participants|||Number
2626655|NCT01898208|Other Pre-specified|Length of Intensive Care Unit Stay||within 14 days of positive blood culture until ICU discharge||||days||Inter-Quartile Range|Median
2626656|NCT01898208|Secondary|Number of Subjects Who Had Negative Blood Cultures Within 3 Days After Enrollment||3 Days after enrollment||||participants|||Number
2626657|NCT01898208|Secondary|Time to Pathogen Identification||Approximately 14 days after positive blood culture|The number of subjects analyzed per arm differs from the number of subjects who completed the study because this outcome measure includes only the subset of subjects who had organisms represented on the rapid multiplex PCR (rmPCR) panel.|||hours||Inter-Quartile Range|Median
2626658|NCT01898208|Secondary|Percent of Contaminated Blood Cultures Not Treated or Treated for Less Than 24 Hours|Contaminated blood cultures were defined as growth of organisms such as coagulase-negative staphylococci from a single blood culture set when greater than or equal to 2 blood culture sets were collected, except among subjects suspected to have true bacteremia associated with central venous catheters or devices.|Within 14 days after positive blood culture||||Percentage of blood cultures|||Number
2626659|NCT01898208|Secondary|Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics|De-escalation included discontinuation of 1 or more antibiotics and/or switching from a broad- to a narrow spectrum antibiotic. Escalation included initiation of 1 or more antibiotics and/or switching from a narrow- to a broad-spectrum antibiotic.|Positive Gram stain, 96 hours after enrollment|Not all subjects experienced de-escalation or escalation of their antibiotics. Participants analyzed per variable below are expressed as (n=control, FilmArray test, and FilmArray+Stewardship).|||hours||Inter-Quartile Range|Median
2626660|NCT01898208|Secondary|Time From Positive Gram Stain to First Active Antibiotic|From positive Gram stain to start of active antibiotic among patients not on active therapy at enrollment; excludes subjects with contaminated blood cultures.|Approximately 14 days after positive blood culture|Not all subjects were not on active therapy at enrollment, and also subjects with contaminated blood cultures were excluded. Participants analyzed per variable below are expressed as (n=control, FilmArray test, and FilmArray+Stewardship): (n=45, 41, 37)|||hours||Inter-Quartile Range|Median
2626661|NCT01898208|Primary|Duration of Antimicrobial Therapy (Hours)|Difference between the date and time of the antibiotic start order (or Gram stain-positive blood culture, if antibiotics were started prior to the positive culture result) and the date and time of the antibiotic stop order. Shorter duration of broad spectrum antibiotics and longer duration of narrow-spectrum antibiotics were considered favorable outcomes.|Approximately 4 days after enrollment|Subjects could have received more than one antimicrobial. Participants analyzed per variable below are expressed as (n=control, FilmArray test, and FilmArray+Stewardship)|||hours||Inter-Quartile Range|Median
2626662|NCT01898195|Secondary|End-of-intervention Smoking Abstinence|number of participants who achieved smoking abstinence based on self-reported 7-day point prevalence smoking abstinence verified by a carbon monoxide (CO) < 8 ppm|7 Days||||participants|||Number
2626663|NCT01898195|Primary|End-of-intervention Varenicline Adherence|number of participants who took at least 80% prescribed dose since last interview, based on pill count|4 Weeks||||participants|||Number
2626664|NCT01898130|Post-Hoc|Progression Free Survival (PFS) in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab|"Progression Free Survival (PFS) is measured from the time of treatment initiation until documentation of progressive disease or death from any cause. To estimate PFS, Kaplan-Meier curves will be calculated and PFS will be determined from the progression-free survival curve.~Progression is defined using Response Assessment in Neuro-Oncology Criteria (RANO), as a 25% or more increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|From treatment initiation and every two cycles (1 cycle = 28 days) until disease progression. Median follow up of 8 months (range 1.3 to 47.9 months).|All patients evaluable for this outcome measure.|||Months||95% Confidence Interval|Median
2628118|NCT01881737|Secondary|Vineland Adaptive Behavior Scale|Adaptive Behavior Composite Score (score range 20-160); higher scores mean more typical adaptive behaviors.|12 weeks||||score (range 20-160)||Standard Deviation|Mean
2626665|NCT01898130|Post-Hoc|Response Rate in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab|"Response Rate is defined as all patients with Complete Response plus those with Partial Response as assessed by Response Assessment in Neuro-Oncology (RANO) Criteria of CT or MRI scans for target lesions combined with clinical assessment. Generally RANO Response definitions are as follows:~CR is defined as the disappearance of all target lesions and PR is defined as >=50% decrease in the sum of the longest diameter of target lesions."|Every other cycle, starting cycle 3 (1 cycle =28 days) until off study. Range of cycles completed 1-20.|3 patients were determined not to be evaluable for response outcome measures as they did not get follow up scans after baseline scans.|||Participants|||Count of Participants
2626666|NCT01898130|Secondary|Quality of Life Assessments in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab|"Changes in quality of life will be evaluated using questionnaires (FACT-Br) at baseline (before treatment initiation) and at cycle 3.~Four FACT scales were calculated. The higher the value the better the score, i.e., the better the quality of life perceived by patient.~FACT-G (Fact General, possible range 0 - 108) BrCS (Brain Cancer Subscale, possible range 0 - 92) TOTAL (FACT-G + BrCS, possible range 0 - 200) TOI (Trial Outcome Index = Physical Well Being _ Functional Well Being +BrCS, possible range 0 - 148)"|Baseline and at Cycle 3 (1 Cycle = 28 days).|12 patients completed quality of life questionnaires at baseline and Cycle 3 and therefore are evaluable for this outcome measure.|||score on a scale||Full Range|Mean
2626667|NCT01898130|Secondary|Toxicity of Bevacizumab in Patients With Recurrent Solid Tumor Brain Metastases|"Adverse events (AE) will be collected at the start of every cycle and graded according NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. All AEs that are determined to be grade 3 or higher and at least possible related to bevacizumab will be reported for toxicity. In general AEs will be graded:~Grade 1 - Mild: the event causes discomfort without disruption of normal daily activities.~Grade 2 - Moderate: the event causes discomfort that affects normal daily activities.~Grade 3 - Severe: the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status.~Grade 4 - Life-threatening: the patient was at risk of death at the time of the event.~Grade 5 - Fatal: the event caused death."|Assessed prior to every cylcle (cycle=28 days) while on treatment through 30 days post last dose. Range of cycles 1-20.|All patients that receive at least one dose of bevacizumab are considered to be evaluable for toxicity outcome measure.|||participants|||Number
2626668|NCT01898130|Secondary|Overall Survival (OS) in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab|Overall Survival (OS) will be measured as the date of first dose of bevacizumab to the date of death from any cause. To estimate OS, Kaplan-Meier curves will be calculated and OS will be determined from the overall survival curve.|From start of treatment until death from any cause. Median follow up of 8 months (range 1.3 to 47.9 months)|All patients included in OS outcome measure.|||Months||95% Confidence Interval|Median
2626669|NCT01898130|Secondary|Duration of Response in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab|The Duration of Overall Response is measured from the time measurement criteria are met for Complete Response (CR) or Partial Response (PR) until the first date that recurrent or Progressive Disease (PD) is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Duration of response will be based on CT or MRI scans and clinical assessment performed prior to every odd-numbered cycle to detect date of first response to study treatment until date of disease progression and assessed by the Response Assessment in Neuro-Oncology (RANO) Criteria for target lesions. Generally CR is defined as the disappearance of all target lesions, PR is defined as >=50% decrease in the sum of the longest diameter of target lesions and PD is defined as a 25% or more increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From documentation of response, every two cycles (1 cycle =28 days) until progressive disease. Range of cycles completed 1-20.|Patients that achieved documented Complete Response or Partial Response were evaluated for this outcome measure|||Days||Full Range|Mean
2626670|NCT01898130|Secondary|Time to Response in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab|MRI or CT scans and clinical assessment will be used to measure Time to Response which will be assessed as the time from the date of first dose to the date of first observed tumor response in all patients that a response is observed. Response to treatment will be assessed using the Response Assessment in Neuro-Oncology (RANO) Criteria for target lesions. Response is defined as either Complete Response (CR) or a Partial Response (PR) radiographically. Generally CR is defined as the disappearance of all target lesions and PR is defined as >=50% decrease in the sum of the longest diameter of target lesions.|From the start of treatment every 2 cycles (1 cycle =28 days) until time of response. Range of cycles completed 1-20.|6 patients experienced a response and were therefore evaluable for this outcome measure.|||Days||Full Range|Mean
2626671|NCT01898130|Secondary|Time to Progression in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab|MRI or CT scans and clinical assessment will be used to measure Time to Progression which will be assessed as the time from the date of first dose to the date of first observation of progressive disease, non-reversible neurologic progression or increasing steroid requirements, or early discontinuation of treatment as assessed by the RANO Criteria in those patients that experience response.|From treatment initiation, every 2 cycles (1 cycle = 28 days) until progressive disease. Range of cycles completed 1-20.|6 patients experienced response and were evaluable for this outcome measure|||Days||Full Range|Mean
2626672|NCT01898130|Secondary|Progression-Free Survival (PFS) at 6 Months in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab|"Progression-Free Survival (PFS) will be measured as the time from the first dose to the first occurrence of progression or death for any reason. To estimate PFS, Kaplan-Meier curves will be calculated and PFS at 6 months will be determined from the progression-free survival curve.~Progression is defined using Response Assessment in Neuro-Oncology Criteria (RANO), as a 25% or more increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|At 6 months from treatment initiation.||||percentage of patients with PFS||95% Confidence Interval|Median
2626791|NCT01897077|Primary|The Proportion of Subjects That Discontinue the Study for Treatment Related Reasons|No healthy volunteers discontinued the study for treatment related reasons. No active participants enrolled.|18 months|There were no peanut allergic subjects enrolled because the study ended prematurely due to manufacturing issues with the study product.|||Participants|||Count of Participants
2638926|NCT01769326|Other Pre-specified|Range of Motion of Shoulder Joint||1 month|||||||
2626673|NCT01898130|Primary|Objective Radiographic Tumor Response in Patients With Recurrent Solid Tumor Brain Metastases Treated With Bevacizumab|Radiographic Response to treatment will be assessed prior to every odd-numbered cycle using CT or MRI scans until disease progression, unacceptable toxicity as assessed by the Response Assessment in Neuro-Oncology (RANO) Criteria for target lesions. Response is defined as the number of patients with Complete Response (CR) plus those with Partial Response (PR) radiographically. Generally CR is defined as the disappearance of all target lesions and PR is defined as >=50% decrease in the sum of the longest diameter of target lesions.|Every other cycle, starting cycle 3 (1 cycle =28 days) until off study. Range of cycles completed 1-20.|Not all patients treated on study were determined to be evaluable for this objective as they did not receive follow up scans after the baseline scans.|||Participants|||Count of Participants
2626674|NCT01898091|Primary|Maximum Change in Mean Mouth and Throat Soreness (MTS) Score From Baseline Through Weeks of Radiation Therapy Using the MTS Question of the Modified Oral Mucositis Daily Questionnaire*.|"Severity is assessed as the maximum change in mean mouth and throat soreness (MTS) score from baseline during the weeks of RT, using MTS question of the validated Oral Mucositis Daily Questionnaire (modified OMDQ): During the past 24 hours, how much mouth and throat soreness did you have? The MTS score is a 5-point score, ranging from 0=No soreness to 4=Extreme soreness. We compared the maximum change in MTS score between the two groups using the Wilcoxon rank sum test with a one-sided alpha of 0.05."|MTS score is collected at the baseline visit and once each week during the 7 weeks of radiation therapy.|Exclusion criterion was those with a baseline mouth and throat soreness (MTS) extreme score of 4.|||units on a scale||Standard Deviation|Mean
2626675|NCT01898078|Secondary|Number of Participants With Clinically Significant Change in Vital Sign Reported as AEs|The number of participants with any clinical significant change in vital signs (sitting diastolic and systolic blood pressure, heart rate, and temperature) were collected throughout the study.|From first dose through 30 days after the last dose of study drug (up to 225 days)|Safety population included all enrolled participants who received at least one dose of study drug. According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.|||Participants|||Count of Participants
2626676|NCT01898078|Secondary|Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs|The number of participants with any clinical significant change in safety laboratory values collected throughout the study.|From first dose through 30 days after the last dose of study drug (up to 225 days)|Safety population included all enrolled participants who received at least one dose of study drug. According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.|||Participants|||Count of Participants
2626677|NCT01898078|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.~A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|From first dose through 30 days after the last dose of study drug (up to 225 days)|Safety population included all enrolled participants who received at least one dose of study drug. According to the protocol analysis planned, data for the safety and tolerability was collected as per the treatment sequence received in the study, irrespective of the fed or fasted condition.|||Participants|||Count of Participants
2626678|NCT01898078|Primary|AUC∞: Area Under the Plasma Concentration Curve From Time 0 to Infinity of Alisertib||Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|PK population included participants with sufficient dosing data and PK concentration-time data to reliably estimate the PK parameters. Here, number of participants analysed are the participants who were evaluable for this outcome measure.|||hr*nM||Standard Deviation|Mean
2626679|NCT01898078|Primary|AUC(Last): Area Under the Plasma Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration of Alisertib||Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|PK population included participants with sufficient dosing data and PK concentration-time data to reliably estimate the PK parameters.|||hr*nM||Standard Deviation|Mean
2626680|NCT01898078|Primary|Cmax: Maximum Observed Plasma Concentration of Alisertib||Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose|Pharmacokinetic (PK) population included participants with sufficient dosing data and PK concentration-time data to reliably estimate the PK parameters.|||nM||Standard Deviation|Mean
2626681|NCT01898013|Secondary|Change in Digit Sequence (Visit 6-Baseline)|Digit Sequencing Task is a clinician administered subtest from the Brief Assessment of Cognition-Affect (BAC-A) which measures working memory and attention. Participants were presented with clusters of numbers of increasing length.They were asked to tell the experimenter the numbers in order, from lowest to highest. Measures: number of correct responses (range: 0-28, higher is better). Scores converted to Z-scores. The outcome measure is the change in Z scores before and after treatment. That is, the baseline and Visit 6 difference scores.|Difference Z-Scores (Visit 6-Baseline)||||units on a scale||Standard Deviation|Least Squares Mean
2626682|NCT01898013|Secondary|Change in Tower of London (Visit 6-Baseline)|The Tower of London is a clinician administered subtest from the Brief Assessment of Cognition-Affect (BAC-A) which measures executive functioning. Participants were shown two pictures simultaneously. Each picture showed three balls of different colors arranged on three pegs, with the balls in a unique arrangement in each picture. Participants were asked to give the total number of times the balls in one picture need to be moved in order to make the arrangement of balls identical to that of the other, opposing picture. There were 20 trials, 2 more were added if all 10 prior trials were correct. Range of scores was 0-22, higher scores are better. Z scores calculated and reported. The outcome measure is the change in Z scores before and after treatment. That is, the baseline and Visit 6 difference scores.|Difference Z-Score (Visit 6-Baseline)||||units on a scale||Standard Deviation|Least Squares Mean
2626792|NCT01897025|Secondary|MRI Parameters|active and passive fMRI, DTI, This part of data is still under analyzing.|-2, 0 and 4 weeks||2015-12-31|12/2015||||
2640255|NCT01756391|Secondary|Days of Slowed Activity Due to Asthma||12 months|||||||
2626683|NCT01898013|Secondary|Change in Davidson Trauma Scale (Visit 6-Baseline)|"The Davidson Trauma Scale (DTS) is a 17-item self-report measure that assesses the 17 DSM-IV symptoms of PTSD. Items are rated on 5-point frequency (0 = not at all to 4 = every day) and severity scales (0 = not at all distressing to 4 = extremely distressing). Respondents are asked to identify the trauma that is most disturbing to them and to rate, in the past week, how much trouble they have had with each symptom. The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores."|Difference Scores of Total DTS Scores (Visit 6-Baseline)||||units on a scale||Standard Error|Least Squares Mean
2626684|NCT01898013|Secondary|Change in Beck Depression Inventory (Visit 6-Baseline)|The Beck Depression Inventory is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression (Beck, et al., 1961). Scores range from 0 (no depression) to 63 (severe depression). The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.|Difference Scores of BDI (Visit 6-Baseline)||||units on a scale||Standard Deviation|Least Squares Mean
2626685|NCT01898013|Secondary|Change in Pain Interference Scores (Visit 6-Baseline)|The The Brief Pain Inventory (BPI) is a self-reported scale that measures the severity of pain and the interference of pain on function. The scores range from 0 (no pain) to 10 (pain as severe as you can imagine). There are 4 questions assessing worst pain, least pain, average pain in the past 24 hours, and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.|Difference Scores of Averaged Pain Interference Domains (Visit 6-Baseline)||||units on a scale||Standard Error|Least Squares Mean
2626686|NCT01898013|Primary|Change in Pain Intensity Rating (Visit 6-Baseline)|Weekly mean of the 24-hour average pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst pain). The outcome measure is the change in scores before and after treatment. That is, the baseline and Visit 6 difference scores.|Difference Scores (Visit 6-Baseline)||||units on a scale||Standard Error|Least Squares Mean
2626687|NCT01897896|Secondary|Change From Week 8 in UHDRS Motor Assessment: TMS at Week 171|Components of full UHDRS assess motor function,cognition,behaviour,functional abilities,independence scale,total functional capacities. Motor function assessment includes TMS and TMC score. TMS assesses all motor features of HD and includes maximal chorea, maximal dystonia,ocular pursuit,saccade initiation and velocity,dysarthria,tongue protrusion,finger tapping,hand pronation and supination,luria rigidity,bradykinesia,gait,tandem walking,retropulsion pull test. Each of these was rated on a scale of 0(normal motor function) to 4(severely impaired motor function). TMS score is a sum of individual scores ranging from 0(normal motor function) to 124(severely impaired motor function). Lower TMS scores= better motor function. Data was available for total safety population, not by individual cohorts(rollover and switch cohort) from Week 8 to Week 171,as was done for change from baseline. Therefore, in order to present results data,the total,combined safety population treatment arm was used.|Week 8, Week 171|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2626688|NCT01897896|Secondary|Change From Baseline in UHDRS Motor Assessment: Total Motor Score (TMS) at Week 171|UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of the clinical features and course of HD. Components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Motor function assessment includes TMS and TMC score. The UHDRS TMS assesses all the motor features of HD and includes maximal chorea, maximal dystonia, ocular pursuit, saccade initiation and velocity, dysarthria, tongue protrusion, finger tapping, hand pronation and supination, luria, rigidity, bradykinesia, gait, tandem walking, and retropulsion pull test. Each of these was rated on a scale of 0 (normal motor function) to 4 (severely impaired motor function). TMS score is a sum of individual scores ranging from 0 (normal motor function) to 124 (severely impaired motor function). Lower TMS scores indicate better motor function.|Baseline, Week 171|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2626689|NCT01897896|Secondary|Change From Week 8 in UHDRS Motor Assessment: TMC Score at Week 171|UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of clinical features and course of HD. Components of full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Motor function assessment includes TMS and TMC score. TMC score is determined from Item 12 (maximal chorea) of UHDRS TMS and quantifies chorea based on assessments of the face, bucco-oral-lingual area, trunk, and the 4 extremities. TMC score is a sum of chorea scores in the 7 body regions, ranging from 0(absent chorea) to 28 (marked/prolonged chorea). Lower TMC scores indicated less chorea. Data was measured and available for total safety population. Data was not available by individual cohorts (rollover cohort and switch cohort) from Week 8 to Week 171, as was done for change from baseline. Therefore, in order to present results data for this outcome measure, the total, combined safety population treatment arm was used.|Week 8, Week 171|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2626696|NCT01897896|Secondary|Change From Baseline in Montreal Cognitive Assessment (MoCA) Total Score at Week 171|MoCA is a validated rapid screening instrument for assessing mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation by using 30 questions test. Time to administer the MoCA© is approximately 10 minutes. The total possible score ranges from 0 (worst) to 30 (best) points; where higher scores indicate better cognitive function. A score of 26 or above is considered normal and a score below 26 is considered as recognitive dysfunction.|Baseline, Week 171|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2626690|NCT01897896|Secondary|Change From Baseline in UHDRS Motor Assessment: Total Maximal Chorea (TMC) Score at Week 171|UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of the clinical features and course of HD. Components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Motor function assessment includes total motor score (TMS) and TMC score. TMC score is determined from Item 12 (maximal chorea) of UHDRS TMS and quantifies chorea based on assessments of the face, bucco-oral-lingual area, trunk, and the 4 extremities. TMC score is a sum of chorea scores in the 7 body regions, ranging from 0 (absent chorea) to 28 (marked/prolonged chorea). Lower TMC scores indicated less chorea.|Baseline, Week 171|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2626691|NCT01897896|Secondary|Change From Baseline in UHDRS Cognitive Assessment Score at Week 171|Components of UHDRS assess motor function,cognition,behaviour,functional abilities,independence scale, total functional capacities. Cognitive assessment component:verbal fluency(VF) score (memory,attention)(requiring participant to generate as many words as possible beginning with a specific letter[F,A,S]in 60 seconds [sec]. Score[no range]:total number of correct words for 3 letters), symbol digit modalities test(SDMT) score(psychomotor speed,attention)(participant is required to pair digits to assigned symbols using a reference key. Score[0 {worst}-120 {best}]:total number of correct written responses in 90 sec), & Stroop interference(SI) score (selective attention,executive function)(includes 3 conditions:naming colour blocks[blue, red or green]; reading colour words printed in black ink; naming ink colour of incongruous colour words. For each condition score(no range)is number of correct responses produced in 45 sec). In these tests, higher scores reflect better cognitive ability.|Baseline, Week 171|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.|||units on a scale||Standard Deviation|Mean
2626692|NCT01897896|Secondary|Change From Baseline in UHDRS Total Functional Capacity (TFC) Score at Week 132|UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of the clinical features and course of HD. Components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities (TFC). TFC is a 5-item clinician rating scale typically completed after a brief interview with a participant and/or collateral source. TFC globally assesses occupation, finances, domestic chores, activities of daily living, and level of care, with scores on each item ranging from 0 to either 2 or 3 (e.g., Occupation: 0 = unable, 1 = marginal work only, 2 = reduced capacity for usual job, 3 = normal). The five items are summed to yield a TFC total score, which ranges from 0 (normal function) to 13 (severe dysfunction). Higher scores indicated better functioning.|Baseline, Week 132|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2626693|NCT01897896|Secondary|Change From Baseline in UHDRS Independence Scale Score at Week 28|UHDRS: research tool to provide a uniform assessment of clinical features and course of HD. Components of UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Independence scale ranges from 10-100, indicating most accurate current level of participant's independence. 10=Tube fed, total bed care; 20=No speech, must be fed; 30=Participant provides minimal assistance in own feeding,bathing,toileting; 40=Chronic care facility needed; limited self-feeding; 50=24-hour supervision appropriate; assistance required for bathing,eating,toileting; 60=Needs minor assistance in dressing,toileting,bathing; 70=Self-care maintained for bathing,limited household duties; unable to manage finances; 80=Pre-disease level of employment changes or ends; cannot perform household chores, may need help with finances; 90=No physical care needed(difficult tasks avoided); 100=No special care needed. Higher scores indicate better independence.|Baseline, Week 28|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2626694|NCT01897896|Secondary|Change From Baseline in UHDRS Functional Assessment Score at Week 28|The UHDRS is a research tool developed by HD Study Group to provide a uniform assessment of the clinical features and course of HD. The components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Functional assessment included 25 questions with possible answers 'yes' or 'no'. Total score ranges from 0 (worst) to 25 (best). Higher scores indicate better functional ability.|Baseline, Week 28|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2626695|NCT01897896|Secondary|Change From Baseline in Unified Huntington's Disease Rating Scale (UHDRS) Total Behavior Score at Week 171|The UHDRS is a research tool developed by the Huntington Disease (HD) Study Group to provide a uniform assessment of the clinical features and course of HD. The components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. The total behavior score is made up of subscores evaluating depressed mood, apathy, low self-esteem/guilt, compulsive behavior, anxiety, irritable behavior, perseverative/obsessive thinking, disruptive/aggressive behavior, suicidal thoughts, delusions, and hallucinations. For each subscore the frequency and severity was assessed separately. Frequency was rated on a scale of 0 (never or almost never) to 4 (very frequently, most of the time). Severity was rated on a scale of 0 (no evidence) to 4 (severe). Total behavior score ranges from 0 (no impairment) to 88 (severe impairment). Higher scores indicated greater behavioral impairments.|Baseline, Week 171|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2626732|NCT01897792|Secondary|Number of Protocol Violations Per Arm.|The number of times that there was a deviation or violation from how the protocol was to be implemented.|from enrollment up to 60 days post enrollment||||protocol deviations|||Number
2626733|NCT01897792|Primary|Number of Total Blood Product Transfusions|the number of blood product transfusions for all subjects in each group over the course of 3 days.|From enrollment to 3 days||||blood transfusions|||Number
2637570|NCT01780922|Primary|Interleukin-1alpha (IL-1a) Concentrations in Plasma||0, 2, 4, 8, 24 h||||pg/mL||Standard Error|Mean
2626697|NCT01897896|Secondary|Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)|"C-SSRS is a clinician rated assessment of suicidal behavior and ideation categorized as: Suicidal behavior=a yes response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, non-fatal suicide attempt, and completed suicide); Suicidal ideation=a yes response to any one of 5 suicidal ideation questions which includes wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Number of participants with positive response (response of yes) to suicidal behavior, ideation or any non-suicidal self-injurious behavior was reported."|Baseline up to 1-week follow-up visit (up to approximately 3 years 9 months)|Safety population included all participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2626698|NCT01897896|Secondary|Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 171|ESS is a self-administered questionnaire comprised of 8 questions that provides a measure of a participant's general level of daytime sleepiness. Participants were asked to rate their usual chances of dozing off or falling asleep in different situations or activities that most people engage in as part of their daily lives (sitting and reading; watching TV; sitting inactive in a public place; as a passenger in a car for an hour without a break; lying down to rest in the afternoon when circumstances permit; sitting and talking to someone; sitting quietly after a lunch without alcohol; in a car, while stopped for a few minutes in traffic), on a 4-point Likert scale ranging from 0 to 3, where 0=no chance; 1=slight chance; 2=moderate chance; 3=high chance. Total ESS score is the sum of 8 item-scores and can range between 0 and 24 with a higher the score indicating a higher level of daytime sleepiness.|Baseline, Week 171|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2626699|NCT01897896|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score at Week 171|HADS is a self-administered instrument reliable for detecting states of depression and anxiety It includes 2 subscales: Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (HADS-D) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranged from 0 to 21 for each subscale; where higher score indicated greater severity of anxiety and depression symptoms.|Baseline, Week 171|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2626700|NCT01897896|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score at Week 171|HADS is a self-administered instrument reliable for detecting states of depression and anxiety It includes 2 subscales: Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (HADS-D) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score ranged from 0 to 21 for each subscale; where higher score indicated greater severity of anxiety and depression symptoms.|Baseline, Week 171|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2626701|NCT01897896|Secondary|Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Assessment Score at Week 171|BARS is a rating scale for evaluation of drug-induced akathisia. It includes a summary score (objective assessment of akathisia and subjective measures [self-awareness and distress]) and a global clinical assessment. Global clinical assessment rated on a scale ranging from 0 to 5, where 0=Absent. No evidence of awareness of restlessness; 1=Questionable. Non-specific inner tension and fidgety movements; 2=Mild akathisia. Awareness of restlessness in legs and/or inner restlessness worse when required to stand still. Fidgety movements present, but characteristic restless movements not necessarily observed; 3=Moderate akathisia. Awareness of restlessness combined with characteristic restless movements; 4=Marked akathisia. Subjective experience of restlessness includes a compulsive desire to walk or pace; 5=Severe akathisia. Strong compulsion to pace up and down most of the time. Constant restlessness associated with intense distress and insomnia. Higher scores indicated more akathisia.|Baseline, Week 171|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2626702|NCT01897896|Secondary|Change From Baseline in Barnes Akathisia Rating Scale (BARS) Summary Score at Week 171|BARS is a rating scale for evaluation of drug-induced akathisia. It includes a summary score (objective assessment of akathisia and subjective measures [self-awareness and distress]) and a global clinical assessment. Objective akathisia rated on a scale of 0-3 (0=normal, occasional fidgety movements of limbs; 1=characteristic restless movements for less than half the time observed; 2= characteristic restless movements for at least half the time observed; 3=constant characteristic restless movements). Subjective measures included awareness of restlessness (rated on a scale of 0 [absence of inner restlessness] to 3 [awareness of intense compulsion to move]) and distress related to restlessness (rated on a scale of 0 [no distress] to 3 [severe distress]). Objective akathisia and subjective measures summed to yield summary score ranging from 0 (no akathisia and restlessness) to 9 (severe akathisia and restlessness), where higher scores indicated more akathisia and restlessness.|Baseline, Week 171|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2626734|NCT01897792|Primary|Number of Subjects With Organ Injury|Any injury to internal organs (thoracic, abdominal or cranial cavity)|From enrollment to 3 days||||participants|||Number
2629500|NCT01865448|Primary|Proresolution Index|Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators|6 months||||ratio||Standard Deviation|Mean
2626703|NCT01897896|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) -Dysarthria Score at Week 171|The UPDRS is a comprehensive instrument used to assess the signs and symptoms of Parkinson's disease and includes patient and clinician-based assessments of motor, cognitive, and behavioral symptoms. The UPDRS-Dysarthria question pertaining to speech/dysarthria was used to monitor study participants for parkinsonism. Participants rated their responses on a scale ranging from 0 to 4, where 0 = normal; 1 = mildly affected, no difficulty being understood; 2 = moderately affected, sometimes asked to repeat statements; 3 = severely affected, frequently asked to repeat statements; 4 = unintelligible most of the time. Higher scores indicated greater impairment.|Baseline, Week 171|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||units on a scale||Standard Deviation|Mean
2626704|NCT01897896|Secondary|Duration of Time to Achieve a Stable Dose of SD-809 ER|Duration of time to achieve stable dose of SD-809, defined as the number of days from Day 1 until the first day at which the participant was taking the dose level they were receiving at Week 8.|From Day 1 until the first day at which the participant was taking the dose level they were receiving at Week 8 (up to maximum 1284 days)|Safety population included all participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||days||Full Range|Median
2626705|NCT01897896|Secondary|Number of Participants With Clinically Significant Abnormalities in ECG Parameters|ECG parameters included heart rate, PR interval, QRS duration, QT interval and QTcF. Clinical significance was as as per Investigator's discretion.|Baseline, Week 8|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||Participants|||Count of Participants
2626706|NCT01897896|Secondary|ECG Parameter Value (PR Interval, QRS Duration, QT Interval, QTcF) at Baseline and Week 8|ECG parameters included heart rate, PR interval, QRS duration, QT interval and QTcF. PR interval, QRS duration, QT interval and QTcF at Baseline and Week 8 is reported in this outcome measure.|Baseline, Week 8|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure for specified categories.|||milliseconds||Standard Deviation|Mean
2626707|NCT01897896|Secondary|Electrocardiogram (ECG) Parameter Value (Heart Rate) at Baseline and Week 8|ECG parameters included heart rate, PR interval, QRS duration, QT interval and Fridericia's corrected QT interval (QTcF). Heart rate measured by ECG at Baseline and Week 8 is reported in this outcome measure.|Baseline, Week 8|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||beats/minute||Standard Deviation|Mean
2626708|NCT01897896|Secondary|Change From Baseline in Body Temperature at Week 171|Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171.|Baseline, Week 171|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||degrees centigrade||Standard Deviation|Mean
2626709|NCT01897896|Secondary|Change From Baseline in Respiration Rate at Week 171|Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171.|Baseline, Week 171|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||breaths/minute||Standard Deviation|Mean
2626710|NCT01897896|Secondary|Change From Baseline in Heart Rate at Week 171|Heart rate was assessed in seated/supine position. Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171.|Baseline, Week 171|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||beats per minute||Standard Deviation|Mean
2626711|NCT01897896|Secondary|Change From Baseline in Blood Pressure at Week 171|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were assessed in seated/supine position. Observed value at baseline and observed value at Week 171 were used to calculate the change from baseline value at Week 171.|Baseline, Week 171|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number of participants analyzed' signifies participants evaluable for this outcome measure for specified categories.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2626712|NCT01897896|Secondary|Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bilirubin, Creatinine, Direct Bilirubin, and Urate) at Week 158|Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in bilirubin, creatinine, direct bilirubin, and urate at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.|Baseline, Week 158|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.|||micromoles per liter||Standard Deviation|Mean
2626713|NCT01897896|Secondary|Change From Baseline in Clinical Laboratory Serum Chemistry Parameter (Creatinine Clearance) at Week 106|Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in creatinine clearance at baseline and Week 106 is reported in this outcome measure. Observed value at baseline and observed value at Week 106 were used to calculate the change from baseline value at Week 106.|Baseline, Week 106|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||milliliters per minute (mL/min)||Standard Deviation|Mean
2626714|NCT01897896|Secondary|Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Protein and Albumin) at Week 158|Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in protein and albumin at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.|Baseline, Week 158|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.|||g/L||Standard Deviation|Mean
2626715|NCT01897896|Secondary|Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Magnesium, Phosphate, Potassium, Sodium, Triglycerides) at Week 158|Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium and triglycerides at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.|Baseline, Week 158|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.|||millimoles per liter (mmol/L)||Standard Deviation|Mean
2626716|NCT01897896|Secondary|Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Aspartate Aminotransferase and Lactate Dehydrogenase) at Week 158|Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in aspartate aminotransferase and lactate dehydrogenase at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.|Baseline, Week 158|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.|||units per liter (U/L)||Standard Deviation|Mean
2626717|NCT01897896|Secondary|Change From Baseline in Clinical Laboratory Serum Chemistry Parameters (Alanine Aminotransferase and Alkaline Phosphatase) at Week 158|Clinical laboratory serum chemistry parameters included alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, lactate dehydrogenase, bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, magnesium, phosphate, potassium, sodium, triglycerides, protein, albumin, creatinine clearance, bilirubin, creatinine, direct bilirubin, and urate. Change from baseline in alanine aminotransferase and alkaline phosphatase at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.|Baseline, Week 158|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.|||international units per liter (IU/L)||Standard Deviation|Mean
2626718|NCT01897896|Secondary|Change From Baseline in Clinical Laboratory Hematology Parameter (Hemoglobin) at Week 158|Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in hemoglobin at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.|Baseline, Week 158|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||grams per liter (g/L)||Standard Deviation|Mean
2626719|NCT01897896|Secondary|Change From Baseline in Clinical Laboratory Hematology Parameter (Hematocrit) at Week 158|Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Hematocrit levels were calculated as the ratio of the volume of red cells to the volume of whole blood. Change from baseline in hematocrit at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.|Baseline, Week 158|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||ratio||Standard Deviation|Mean
2626720|NCT01897896|Secondary|Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes) at Week 158|Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in erythrocytes at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.|Baseline, Week 158|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||10^12 cells per liter||Standard Deviation|Mean
2626721|NCT01897896|Secondary|Change From Baseline in Clinical Laboratory Hematology Parameter (Erythrocytes Mean Corpuscular Volume) at Week 158|Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in erythrocytes mean corpuscular volume at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed value at Week 158 were used to calculate the change from baseline value at Week 158.|Baseline, Week 158|Safety population included all participants received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints.|||femtoliter (fL)||Standard Deviation|Mean
2626722|NCT01897896|Secondary|Change From Baseline in Clinical Laboratory Hematology Parameters (Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets) at Week 158|Clinical laboratory hematology parameters included basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils, platelets, erythrocytes mean corpuscular volume, erythrocytes, hematocrit, and hemoglobin. Change from baseline in basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets cells at baseline and Week 158 is reported in this outcome measure. Observed value at baseline and observed values at Week 158 were used to calculate the change from baseline value at Week 158.|Baseline, Week 158|Safety population included all participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories.|||10^9 cells per liter||Standard Deviation|Mean
2626723|NCT01897896|Primary|Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Long Term Stable Dose Treatment|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AEs=inability to carry out usual activities. Drug-related TEAEs: TEAEs with a possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Week 8 to follow-up visit (up to approximately 3 years 9 months)|Safety population included all participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.|||Participants|||Count of Participants
2626724|NCT01897896|Primary|Switch Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Dose Adjustment|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AEs=inability to carry out usual activities. Drug-related TEAEs: TEAEs with a possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Day 1 to end of Week 4|Safety population included all participants received at least 1 dose of study drug.|||Participants|||Count of Participants
2626725|NCT01897896|Primary|Rollover Cohort: Number of Participants With TEAEs, Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Titration|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AEs=inability to carry out usual activities. Drug-related TEAEs: TEAEs with a possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Day 1 to end of Week 8|Safety population included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2626726|NCT01897896|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Withdrawal During Entire Treatment Period|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severe AE=inability to carry out usual activities. Drug-related TEAEs: TEAEs with possible, probable, definite, or missing relationship to study drug. Serious AEs: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: events that 1) began after treatment with study drug in current study and that were not present at baseline or 2) if present at baseline, had worsened in severity. Any TEAEs included both serious and non-serious TEAEs. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline to follow-up visit (up to approximately 3 years 9 months)|Safety population included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2626727|NCT01897792|Secondary|Mean Number of Hospital Stay Days.|The mean number of days subjects were in the hospital in each arm of the study|from enrollment up to 60 days post enrollment||||days||Full Range|Mean
2626728|NCT01897792|Secondary|Mean Number of Days in ICU.|the mean number of days each subject was in the ICU in each arm|from enrollment up to 60 days post enrollment||||days||Full Range|Mean
2626729|NCT01897792|Secondary|Mean Number of Ventilator-free Days for Subjects|The mean number of ventilator free days (not on ventilator) for subjects in each arm|from enrollment up to 60 days post enrollment||||days||Full Range|Mean
2626730|NCT01897792|Secondary|Number of Subjects With 60-day Survival|Number of subjects in each arm that survived to day 60|from enrollment up to 60 days post enrollment||||participants|||Number
2626731|NCT01897792|Secondary|Number of Subjects Surviving to Day 28|Number of subjects that survived to day 28 after enrollment|from enrollment up to 28 days post enrollment||||participants|||Number
2633472|NCT01824446|Primary|Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||hours||Standard Deviation|Mean
2626736|NCT01897792|Primary|Number of Participants With Coagulation Abnormalities|Coagulation parameters are evaluated using standard functional tests (prothrombin time (PT), partial thromboplastin time (PTT), fibrinogen and platelet count)and point of care functional analysis using thromboelastogram (TEG-ROTEM). A blood sample is collected upon arrival in the emergency department at 0 hours only and analyzed for markers of activation of coagulation, inflammation, and levels of vitamin C/E.|From enrollment up to 3 days||||participants|||Number
2626737|NCT01897766|Secondary|Change in Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height From Baseline|Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population. Near final height was defined as the height at one of the following conditions: the annual height velocity became less than 2 cm/year after reaching the maximum height in puberty, bone age reached 17 years old and older for male and 15 years old and older for female, or the reason for discontinuation was that subject reached the near final height or had epiphyseal closure.|Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years|The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Among the efficacy analysis set, the participants who reached near final height was analyzed.|||SD score||Standard Deviation|Mean
2626738|NCT01897766|Secondary|Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height|Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population. Near final height was defined as the height at one of the following conditions: the annual height velocity became less than 2 cm/year after reaching the maximum height in puberty, bone age reached 17 years old and older for male and 15 years old and older for female, or the reason for discontinuation was that subject reached the near final height or had epiphyseal closure.|Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years|The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Among the efficacy analysis set, the participants who reached near final height was analyzed.|||SD score||Standard Deviation|Mean
2626739|NCT01897766|Primary|Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10|Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.|Baseline, Year 10|"The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||SD score||Standard Deviation|Mean
2626740|NCT01897766|Primary|Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 9|Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.|Baseline, Year 9|"The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||SD score||Standard Deviation|Mean
2626741|NCT01897766|Primary|Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7|Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.|Baseline, Year 7|"The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||SD score||Standard Deviation|Mean
2626742|NCT01897766|Primary|Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6|Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.|Baseline, Year 6|"The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||SD score||Standard Deviation|Mean
2626743|NCT01897766|Primary|Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5|Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.|Baseline, Year 5|"The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||SD score||Standard Deviation|Mean
2626793|NCT01897025|Secondary|Box and Block Test|Box and block test was to measure the gross manual dexterity. This part of data is still under analyzing.|pre and post training, and 4 weeks post training||2015-12-31|12/2015||||
2637571|NCT01780922|Primary|Nitric Oxide (NO) Concentrations in Plamsa||0, 2, 4, 8, 24 h||||umol/L||Standard Error|Mean
2626744|NCT01897766|Primary|Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4|Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.|Baseline, Year 4|"The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||SD score||Standard Deviation|Mean
2626745|NCT01897766|Primary|Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3|Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.|Baseline, Year 3|"The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||SD score||Standard Deviation|Mean
2626746|NCT01897766|Primary|Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2|Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.|Baseline, Year 2|"The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||SD score||Standard Deviation|Mean
2626747|NCT01897766|Primary|Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 1|Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.|Baseline, Year 1|"The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||SD score||Standard Deviation|Mean
2626748|NCT01897766|Primary|Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10|Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.|Baseline, Year 10|"The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||SD score||Standard Deviation|Mean
2626749|NCT01897766|Primary|Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7|Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.|Baseline, Year 7|"The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||SD score||Standard Deviation|Mean
2626750|NCT01897766|Primary|Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6|Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.|Baseline, Year 6|"The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||SD score||Standard Deviation|Mean
2626751|NCT01897766|Primary|Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5|Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.|Baseline, Year 5|"The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||SD score||Standard Deviation|Mean
2626752|NCT01897766|Primary|Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4|Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.|Baseline, Year 4|"The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||SD score||Standard Deviation|Mean
2626753|NCT01897766|Primary|Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3|Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.|Baseline, Year 3|"The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||SD score||Standard Deviation|Mean
2626754|NCT01897766|Primary|Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2|Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.|Baseline, Year 2|"The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||SD score||Standard Deviation|Mean
2626755|NCT01897766|Primary|Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline At Year 1|Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.|Baseline, Year 1|"The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at least once. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||SD score||Standard Deviation|Mean
2626756|NCT01897766|Primary|Number of Participants With Adverse Drug Reaction (ADR)|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Genotropin in a participant who received Genotropin. A serious ADR (SADR) was an ADR resulting in any of the following out comes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Genotropin was assessed by the physician.|Approximately 11.58 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Genotropin.|||Participants|||Number
2626757|NCT01897727|Primary|Severity of Obstructive Sleep Apnea|3 month change in apnea-hypopnea index assessed by diagnostic, full-night polysomnography. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and > 30/h = severe.|baseline and 3 months||||events/hour||Standard Deviation|Mean
2626758|NCT01897532|Secondary|Time to the First Occurrence of Any of the Following Adjudication-confirmed Components: Renal Death, Sustained End Stage Renal Disease (ESRD), or Sustained Decrease of 40% or More in Estimated Glomerular Filtration Rate (eGFR).|"Time to the first occurrence of any of the following adjudication-confirmed components: renal death, sustained ESRD, or sustained decrease of 40% or more in eGFR.~The percentage of observed patients with first occurrence of any of the following adjudication-confirmed components: renal death, sustained ESRD, or sustained decrease of 40% or more in eGFR was reported."|From randomization to individual end of observation; up to 4.3 years|TS|||percentage of participants|||Number
2626759|NCT01897532|Primary|Time to the First Occurrence of Any of the Following Adjudication-confirmed Components of the Primary Composite Endpoint 3-point Major Adverse Cardiovascular (CV) Events (3-point MACE): CV Death, Non-fatal Myocardial Infarction (MI) or Non-fatal Stroke.|Time to event analysis of patients with first occurrence of any of the following adjudication-confirmed components of the primary composite endpoint (3-point MACE): CV death, non-fatal MI or non-fatal stroke. The percentage of observed patients with first occurrence of any of the following adjudication-confirmed components of the primary composite endpoint (3-point MACE) was reported.|From randomization to individual end of observation; up to 4.3 years|Treated set (TS): All patients treated with at least one dose of trial medication. If no trial medication was taken at site during the visit, but the medication kit was dispensed to the patient and not all trial medication was returned, the patient was included in the TS.|||percentage of participants|||Number
2626760|NCT01897493|Secondary|Renal Clearance (CLr) of Digoxin|CLr was defined as the volume of serum cleared of digoxin per unit of time after a single dose of digoxin.|Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin|All enrolled participants who received digoxin in Periods 1 and 2 and had evaluable CLr data.|||liters/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2626761|NCT01897493|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin||Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin|All enrolled participants who received digoxin in Periods 1 and 2 and had evaluable tmax data.|||hours||Full Range|Median
2626762|NCT01897493|Primary|PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of Digoxin||Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin|All enrolled participants who received digoxin in Periods 1 and 2 and had evaluable AUC0-∞ data.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2626763|NCT01897493|Primary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Digoxin||Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin|All enrolled participants who received digoxin in Periods 1 and 2 and had evaluable Cmax data.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2626764|NCT01897402|Secondary|Non Solicited Adverse Events|Non solicited local and systemic adverse Event (AE) rates throughout the course of the study, based on laboratory test results, vital signs, examination and questioning the subjects.|up to 6 months|Safety Population: All vaccinated participants, grouped by actual vaccine received.|||participants|||Number
2633473|NCT01824446|Primary|Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||hours||Full Range|Median
2626767|NCT01897285|Secondary|Safety - the Nature and Frequency of Adverse Events|"Safety will be determined by the nature and frequency of Adverse Events. Condition of the skin under and around the dressings along with the incidence of skin irritation will be assessed. The incidence and nature of all adverse events will be recorded.~Condition of the skin was evaluated by the Skin Irritation Scale. The possible responses are doubtful reaction, weak positive reaction, strong positive reaction, extreme positive reaction, irritant reaction, and negative reaction."|7 days||||participants|||Number
2626768|NCT01897285|Primary|Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)|"Adhesion at 7 days measured by:~1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor~Conformability~1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor~Dressing Integrity~1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor~Ease of Application~1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor~Ease of Removal,~1 = Very easy 2 = Easy 3 = Difficult 4 = Very difficult~Adhesive Residue 0 = None 1 = Minimal 2 = Moderate 3 = Considerable~Comfort during removal~1 = Excellent 2 = Good 3 = Average 4 = Poor 5 = Very Poor~Condition of the skin This will be evaluated by the Skin Irritation Scale (Doubtful reaction/weak positive reaction/ strong positive reaction/ extreme positive reaction/irritant reaction/ negative reaction)"|7 days|20/20 subjects completed maximum study participation of 7 days. Two subjects dressings detached very early on so returned for their final evaluation on the second day. The final subject status was recorded as ‘other’ for these two subjects. Many dressings detached when volunteers were away from the clinic and prior to returning for the assessments.|||participants|||Number
2626769|NCT01897233|Secondary|Part B: Pre-dose Concentration (Ctrough) and 3 to 6 Hours Post-dose Concentration (C3-6hr) of Lumacaftor, Lumacaftor Metabolite (M28-LUM), Ivacaftor and Ivacaftor Metabolites (M1-IVA and M6-IVA)|Ctrough and C3-6hr for lumacaftor, M28 lumacaftor (lumacaftor metabolite), ivacaftor, M1 ivacaftor (ivacaftor metabolite), and M6 ivacaftor (ivacaftor metabolite) were calculated. Ctrough was observed pre-dose concentration. C3-6hr was observed concentration at 3 to 6 hours post- dose.|For Ctrough: pre-morning dose on Week 4, Week 6 and Week 24; For C3-6hr: 3 to 6 hours post-morning dose on Day 1, 15 and Week 4|The PK Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable. Here “n” signifies those participants who were evaluable at the specified time point for the given category.|||ng/mL||Standard Deviation|Mean
2626770|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domains at Week 24|The TSQM is a 14-item self-administered questionnaire which measures participants' experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed to a scale from 0 to 100, where higher scores indicate greater satisfaction.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Least Squares Mean
2626771|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Week 24|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2626772|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Height-for-age Z-score at Week 24|Z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is, with range from -infinity to +infinity; where 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. Height, adjusted for age and sex, was analyzed as height-for-age z-score (height z-score). The height-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||z-score||95% Confidence Interval|Least Squares Mean
2626773|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Height at Week 24||Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||centimeter (cm)||95% Confidence Interval|Least Squares Mean
2626774|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Weight-for-age Z-score at Week 24|Z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is, with range from -infinity to +infinity; where 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. Weight, adjusted for age and sex, was analyzed as weight-for-age z-score (weight z-score). The weight-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||z-score||95% Confidence Interval|Least Squares Mean
2626775|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Weight at Week 24||Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||kilograms (kg)||95% Confidence Interval|Least Squares Mean
2626794|NCT01897025|Secondary|Grip Strength|Grip strength was measured using a hand-held dynamometer. This part of data is still under analyzing.|pre- and post-training, and again at 4 weeks post-training||2015-12-31|12/2015||||
2626809|NCT01896726|Primary|PK: AUC(0-∞) of Levonorgestrel||Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose|All enrolled participants who received study drug (Microgynon in Period 1 and at least 1 dose of baricitinib and Microgynon in Period 2) and had PK data to calculate AUC(0-∞) of levonorgestrel.|||pg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2626776|NCT01897233|Secondary|Part B: Absolute Change From Baseline in BMI-for-age Z-score at Week 24|BMI was defined as weight in kg divided by height*height in m^2. z-score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is, with range from -infinity to +infinity; where 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. BMI, adjusted for age and sex, was analyzed as BMI-for-age z-score (BMI z-score). The BMI-for-age z-scores were calculated using National Center for Health Statistics growth charts.|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||z-score||95% Confidence Interval|Least Squares Mean
2626777|NCT01897233|Secondary|Part B: Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).|Baseline, Week 24|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||kilogram per square meter (kg/m^2)||95% Confidence Interval|Least Squares Mean
2626778|NCT01897233|Secondary|Part B: Absolute Change in Sweat Chloride From Week 24 at Week 26|Sweat samples were collected using an approved collection device. Change = Week 26 minus Week 24.|Week 24, Week 26|The FAS included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||mmol/L||95% Confidence Interval|Least Squares Mean
2626779|NCT01897233|Secondary|Part B: Average Absolute Change From Baseline in Sweat Chloride at Day 15 and at Week 4|Sweat samples were collected using an approved collection device. Baseline was defined as the average of the measurements at screening and on Day 1 pre-dose. Average of Day 15 and Week 4 measurements was taken and change was calculated as: Average (Day 15 and Week 4 measurement) minus Baseline measurement.|Baseline, Day 15 and Week 4|The Full Analysis Set (FAS) included all Part B enrolled participants who were exposed to any amount of Part B study drug. Here “Number of Participants” analyzed signifies those participants who were evaluable for this outcome measure.|||millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2626780|NCT01897233|Secondary|Part A: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first study drug dose through the end of Part A were considered treatment-emergent.|Day 1 up to Day 28|The Safety Set included all participants who received at least 1 dose of study drug. Here “n” signifies those subjects who were evaluable for the specified cohort.|||participants|||Number
2626781|NCT01897233|Secondary|Part A: Observed Plasma Concentration of Lumacaftor Metabolite (M28-LUM) and Ivacaftor Metabolites (M1-IVA and M6-IVA) at Hour 4 Post-dose (C4h) on Day 1 and 14||Day 1, Day 14|The PK Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable.|||ng/mL||Standard Deviation|Mean
2626782|NCT01897233|Primary|Part B: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, inpatient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. AEs with start date or increased severity on or after the first study drug dose to Week 26 were considered treatment-emergent.|Day 1 up to Week 26|The Safety Set included all participants who received any amount of Part B study drug|||participants|||Number
2626783|NCT01897233|Primary|Part A: Area Under the Plasma Concentration-Time Curve From Time 0 to End of Dosing Interval (AUCtau) of Lumacaftor (LUM) and Ivacaftor (IVA)|The AUCtau is the area under the concentration versus time curve from time 0 to time tau, where tau is the time at the end of dosing interval.|Day 14 (pre-morning dose, 4, 6, 12, and 24 hours post-morning dose for LUM; pre-morning dose, 2, 4, 6, 12 hours post-morning dose for IVA)|The PK Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable.|||ng*hr/mL||Full Range|Median
2626784|NCT01897233|Primary|Part A: Observed Plasma Concentration of Lumacaftor (LUM) and Ivacaftor (IVA) at Hour 4 Post-dose (C4h) on Day 14||4 hours post-morning dose on Day 14|The PK Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable.|||ng/mL||Standard Deviation|Mean
2626785|NCT01897233|Primary|Part A: Observed Plasma Concentration of Lumacaftor (LUM) and Ivacaftor (IVA) at Hour 4 Post-dose (C4h) on Day 1||4 hours post-morning dose on Day 1|The Pharmacokinetic (PK) Set included all enrolled participants who received the study drug and for whom the primary PK data were considered to be sufficient and interpretable.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2626786|NCT01897077|Secondary|Number of Participants With Serious Adverse Events With Dosing||18 months|No participants were analyzed for this secondary outcome in the peanut allergic group because no data was collected due to early termination of the study|||participants|||Number
2626787|NCT01897077|Secondary|Changes in Biomarkers (Peanut Specific Immunoglobulin E (IgE) and Immunoglobulin G (IgG), Basophil Reactivity, and Salivary Biomarkers) From Baseline to the End of Therapy|Only in peanut allergic subjects|18 months|No participants were analyzed for this secondary outcome because data was not collected due to early termination of the study||||||
2626795|NCT01897025|Secondary|Resting Motor Threshold of Stroke Affected M1 Motor Cortex|"Resting motor threshold (RMT) is defined as the percentage of maximum stimulator output required to elicit motor evoked potential (MEP) with 50 µV peak-to-peak amplitude in at least 4 out of 8 trials during single-pulse transcranial magnetic stimulation (TMS).~Short intra-cortical inhibition (SICI) and intracortical facilitation (ICF) were measured using paired pulse stimulation with an initial conditioning stimulus of 80% of RMT and a test stimulus of 120% of RMT. MEPs were recorded at inter-stimulus intervals (ISIs) of 2, 4, 6, 10 and 15 ms. ISIs of 1-3 ms typically induce SICI while ISIs of 10-15ms typically reflect ICF.~This part of data is still under analyzing."|pre- and post-training, 4 weeks post-training||2015-12-31|12/2015||||
2626796|NCT01897025|Primary|Upper Extremity Component of Fugl-Meyer Assessment|The total FMA score (range, 0-66) on the stroke-impaired upper extremity was used to measure the motor improvements in this study. Higher score indicates better upper limb motor function. FMA were measured at 3 time points: at baseline (wk 0), at completion of intervention (wk 2), and at a 2-week follow-up (wk 4).|week 0, week 2, week 4|Subjects aged 21 to 70 years who had their first-ever subcortical stroke at least 9 months before recruitment, with moderate to severe impairment of upper extremity function (subscore of the Fugl-Meyer Motor Assessment [FMMA], 11-45), were recruited.|||units on a scale||Standard Deviation|Mean
2626797|NCT01896986|Primary|Immunogenicity to HPV Vaccine Gardasil|To evaluate the long term immunogenicity of the quadrivalent 4/6/11/18 HPV vaccine Gardasil® by following up a cohort of adolescent females aged 16-30 years with PRD or IBD, 5 years post HPV vaccination at the Royal Children's Hospital (RCH) Melbourne .|12 months|No immunogenicity data collected as samples were lost.||||||
2626798|NCT01896934|Secondary|Change in Patient-rated Depression Severity|Change in depression severity measured by the patient-rated Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16). The QIDS-SR16 is a self-report measure of depression severity with a range of 0-27, with higher scores indicative of more severe depression.|Assessed every 2 weeks from baseline to week 12, change from baseline to week 12 is reported||||units on a scale||Standard Error|Mean
2626799|NCT01896934|Secondary|Change in Clinician-rated Depression Severity|Change in depression severity will be measured by the clinician-rated Montgomery Asberg Depression Rating Scale (MADRS), range of 0-60, with higher scores indicating more severe depression|Assessed every 2 weeks from baseline to week 12, change from baseline to week 12 is reported||||units on a scale||Standard Deviation|Mean
2626800|NCT01896934|Primary|Remission of Depression|Montgomery-Asberg Depression Rating Scale (MADRS) is a measure of depression severity. This will be used to define remission as a score of 7 or less.|Week 12|Individuals achieving remission of depression, defined as MADRS score of 7 or less.|||Participants|||Count of Participants
2626801|NCT01896921|Other Pre-specified|Telomerase Activity and Telomere Length.||48 and 96 weeks|||||||
2626802|NCT01896921|Secondary|Proportion of Patients Who Are Virologically Suppressed (HIV RNA < 50 Copies/ml)||96 weeks|||||||
2626803|NCT01896921|Secondary|Number of Participants With Adverse Events||48 and 96 weeks|||||||
2626804|NCT01896921|Secondary|Mean Percent Change in Total Cholesterol, LDL, and HDL||48 and 96 weeks|||||||
2626805|NCT01896921|Primary|Proportion of Patients Virologically Suppressed (HIV RNA <50 Copies/ml) at 48 Weeks.|Proportion of patients virologically suppressed (HIV RNA <50 copies/ml) at 48 weeks.|48 weeks||||Participants|||Count of Participants
2626806|NCT01896895|Secondary|Double-blind MP: Patient Evaluation of Global Response (PEGR) at Final Visit (Day 43-Day 141)|"PEGR scale is a descriptive subjective 9-point response self-rating scale ranging from complete abolishment of signs and symptoms (value=+4) down to very marked worsening (value=-4). Outcome values represent least square means at visit 4 resulting from an ANCOVA with treatment group, pooled site, gender as fixed factors and age as covariates. Missing were set to a zero effect (value=0). Positive values denote an improvement, while negative values denote deterioration."|Baseline, Final Visit (Day 43-Day 141)|FAS was subset of participants in the SES of the double-blind MP for whom at least a baseline value of the JRS severity subscore was available.|||score on a scale||95% Confidence Interval|Least Squares Mean
2626807|NCT01896895|Secondary|Double-blind MP: Change From Baseline in Blepharospasm Disability Index (BSDI) at Day 43 (Visit 4)|BSDI is a scale for assessment of impairment of specific activities of daily living caused by blepharospasm. BSDI consists of six items (driving a vehicle; reading; watching TV; shopping; getting about on foot (walking); doing everyday activities), each ranging from 0 (=no impairment) to 4 (=no longer possible due to illness). The BSDI total score is a mean score for non-missing items ranging from 0 to 4. It is calculated by adding scores of all applicable and answered items, and dividing the resulting sum by the number of items answered. Outcome values represent LS mean differences between baseline and visit 4 (visit 4 value minus baseline value) resulting from ANCOVA with treatment group, pooled site, gender as fixed factors and baseline BSDI total score, age as covariates. Missings were replaced by the LOCF method. Negative values denote an improvement, while positive values denote deterioration vs. baseline.|Baseline, Day 43 (Visit 4)|FAS was subset of participants in the SES of the double-blind MP for whom at least a baseline value of the JRS severity subscore was available.|||score on a scale||95% Confidence Interval|Least Squares Mean
2626808|NCT01896895|Primary|Double-blind MP: Change From Baseline in JRS Severity Subscore at Day 43 (Visit 4)|JRS severity subscore was used to classify individual symptoms of blepharospasm and to determine therapeutic efficacy. JRS severity subscore ranges from 0 to 4, where 0: None; 1: increased blinking present with external stimuli; 2: Mild but spontaneous eyelid fluttering, definitely noticeable, possibly embarrassing, but not functionally disabling, 3: Moderate, very noticeable spasm of eyelids only, mildly incapacitating, 4: Severe, incapacitating spasm of eyelids and possibly other facial muscles. Values represent least square (LS) mean differences between baseline and visit 4 resulting from analysis of covariance (ANCOVA) with treatment group, pooled site, and gender as fixed factors and baseline JRS severity subscore and age as covariates and missings replaced using the last observation carried forward (LOCF) method. Negative values denote improvement, while positive values denote deterioration vs. baseline.|Baseline, Day 43 (Visit 4)|FAS was subset of participants in the SES of the double-blind MP for whom at least a baseline value of the JRS severity subscore was available.|||score on a scale||95% Confidence Interval|Least Squares Mean
2627244|NCT01892267|Secondary|Patency of Feeding Tube|Determine tube patency which is defined as time period between tube placement and need for re-intervention.|2 years|Study terminated prematurely, so that the appropriate follow-up data was not collected.||||||
2626810|NCT01896726|Primary|PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Ethinyl Estradiol||Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose|All enrolled participants who received study drug (Microgynon in Period 1 and at least 1 dose of baricitinib and Microgynon in Period 2) and had PK data to calculate AUC(0-∞) of ethinyl estradiol.|||picograms*hour/milliliter (pg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2626811|NCT01896726|Primary|PK: Cmax of Levonorgestrel||Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose|All enrolled participants who received study drug (Microgynon in Period 1 and at least 1 dose of baricitinib and Microgynon in Period 2) and had PK data to calculate Cmax of levonorgestrel.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2626812|NCT01896726|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol||Days 1 and 29: predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24 and 48 hours post dose|All enrolled participants who received study drug (Microgynon in Period 1 and at least 1 dose of baricitinib and Microgynon in Period 2) and had PK data to calculate Cmax of ethinyl estradiol.|||picograms/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2626813|NCT01896700|Secondary|Change From Baseline in Vestibular Ocular Reflex (VOR) Phase (in Degrees) at 6 Weeks|Mean changes in VOR phase, which is a measure of the timing (in degrees) of the eye movements relative to the chair movement, as measured by rotary chair testing at 6 weeks, will be compared for active and placebo treated subjects using t-tests, or other appropriate statistical analyses. A range of frequencies was tested from 0.04 Hz to 0.64 Hz, as is standard for rotary chair testing. The range of frequencies (i.e. chair speeds) assesses the vestibular system across a range of head movements. This helps to identify abnormality, which may manifest at different frequencies of movement. The measurement outcomes for rotary chair testing are gain, phase and asymmetry of the eye movements.|6 weeks|Explanation of population discrepancy: One participant in the active group declined this test, so was not analyzed.|||change in degrees from baseline||Standard Deviation|Mean
2626814|NCT01896700|Secondary|Change From Baseline in Vestibular Ocular Reflex (VOR) Asymmetry (Percentage Asymmetric) at 6 Weeks|Mean changes in VOR asymmetry, which is a measure of the strength of the eye responses in one direction compared with the other as measured by rotary chair testing at 6 weeks, will be compared for active and placebo treated subjects using t-tests, or other appropriate statistical analyses. A range of frequencies was tested from 0.04 Hz to 0.64 Hz, as is standard for rotary chair testing. The range of frequencies (i.e. chair speeds) assesses the vestibular system across a range of head movements. This helps to identify abnormality, which may manifest at different frequencies of movement. The measurement outcomes for rotary chair testing are gain, phase and asymmetry of the eye movements.|6 weeks|Explanation of population discrepancy: One participant in the active group declined this test, so was not analyzed.|||change in % of asymmetry from baseline||Standard Deviation|Mean
2626815|NCT01896700|Secondary|Change From Baseline in Vestibular-Ocular Reflex (VOR) Gain at 6 Weeks|The most common rotary chair testing is a battery of subtests, each at a specific rate (Hz) of chair rotation from side to side. The participant is secured in the chair in total darkness while the eyes are monitored by infrared cameras. We completed tests from 0.04 to 0.64 Hz to assess the vestibular system across a range of head movements. The chair and participant's head move together while the cameras track the velocity of the eyes; eye velocity reveals how the vestibular system responds to head velocity. VOR gain is the ratio of average chair (i.e. head) velocity to average eye velocity, and is represented on a unitless scale from 0 to 1. VOR gain close to 1 indicates that eye velocity is nearly equal and opposite to head velocity. While there are normative ranges for VOR gain, we are most interested in is change in mean gain (6-week tests minus baseline tests) for the active and placebo groups.|6 weeks|Explanation of population discrepancy: One participant in the active group declined this test, so was not analyzed.|||ratio||Standard Deviation|Mean
2626816|NCT01896700|Secondary|Change From Baseline in Modified Fatigue Index Scale Score at 6 Weeks|Mean changes in the score attached on the Modified Fatigue Index Scale at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis. Scale ranges from 0-84 points, with higher scores indicating greater fatigue.|6 weeks||||change in score from baseline||Standard Error|Mean
2626817|NCT01896700|Secondary|Change From Baseline in Pittsburgh Sleep Quality Assessment Questionnaire Score at 6 Weeks|Mean changes in the score attained on the Pittsburgh Sleep Quality Assessment Questionnaire at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis. Scale ranges from 0-21 points, with higher numbers indicating poorer sleep quality.|6 weeks||||change in score from baseline||Standard Error|Mean
2626818|NCT01896700|Secondary|Change From Baseline in Timed 25 Foot Walk (T25FW) at 6 Weeks|Mean changes in Timed 25 Foot Walk (T25FW) at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis.|6 weeks||||change in seconds from baseline||Standard Error|Mean
2626819|NCT01896700|Secondary|Change From Baseline in Automatic Postural Response (APR) Latency at 6 Weeks|Mean changes in APR latency at 6 weeks will be compared for active and placebo treated subjects using Bayesian analysis.|6 weeks|Population discrepancy: One participant in the intervention group and two participants in the placebo group contributed unusable APR data; due to their balance deficits, the machine could not get an accurate reading for this test. One participant in the intervention group declined this test. These four participants were not included in analysis.|||change in milliseconds from baseline||Standard Error|Mean
2626820|NCT01896700|Primary|Change From Baseline in Timed Up and Go (TUG) Test Time at 6 Weeks|The primary outcome of this study will be the difference between mean change in TUG time between methylphenidate and placebo treated subjects at 6 weeks. Mean changes will be compared for active and placebo treated subjects using Bayesian analysis.|6 weeks||||change in seconds from basline||Standard Error|Mean
2626821|NCT01896687|Primary|Worst Low Back Pain Score|"Low back pain will be measured by the Brief Pain Inventory (BPI). The BPI assesses the severity of pain, location of pain, pain medications, amount of pain relief in the past 24 hours and the past week, and the impact of pain on daily functions. For this study, the worst pain score will be used in the analysis. The worst pain score is rated from 0 meaning no pain to 10 meaning pain as bad as you can imagine."|baseline to 3 weeks post-treatment||||units on a scale||Standard Deviation|Mean
2627245|NCT01892267|Secondary|Repeat Endoscopy for Feeding Tube Placement Due to Retrograde Tube Migration|Patiens who will have retrograde PEG-J tube migration will get repeat endoscopy for PEG-J tube placement|4 weeks||||participants|||Number
2626822|NCT01896557|Other Pre-specified|Comparison of the Primary Outcome With PFA-100 (Collagen/ADP Cartridge)|After 1 week of randomization to ranitidin or omeprazole, the platelet function will also be analysed by other method: PFA-100(Collagen/ADP cartridge).|1 week after drug exposure|Platelet aggregation by PFA-100 was measured after one week of randomized treatment therapy|||seconds||Standard Deviation|Mean
2626823|NCT01896557|Other Pre-specified|Comparing the Main Outcome on Pre-specified Subgroups|"The main outcome will be compared on pre-specified subgroups:~elderly (age > 65 yrs-old) versus non-elderly~male versus female~smoking versus non-smoking patients~obese (BMI > 30 kg/m2) versus non-obese~diabetic versus non-diabetic~patients in use or not in use of statins~presence or not of genetic polymorphisms on cytochrome 2C19."|1 week after drug exposure|||||||
2626824|NCT01896557|Other Pre-specified|Comparison of the Primary Outcome With Bioimpedance Aggregometry|After 1 week of randomization to ranitidin or omeprazole, the platelet function will also be analysed by other method: bioimpedance aggregometry with ADP 10 mcM as reagent|1 week after drug exposure|Platelet aggregation was measured after one week of randomized treatment therapy|||Ohms||Standard Deviation|Mean
2626825|NCT01896557|Primary|Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, Using VerifyNow Method.|One week after starting double-blind, double-dummy, randomized therapy with ranitidin or omeprazole on patients treated with DAPT, platelet function will be compared with the method VerifyNow, in percent Inhibition of Platelet Aggregation (IPA) from baseline. IPA was calculated as the percent change in aggregability from baseline, with the formula IPA = (on-treatment aggregability minus baseline aggregability)/baseline aggregability. Since baseline aggregation is always, per definition, equal or more than on-treatment aggregation, there is no possibility that this number might be negative.|One week after drug exposure (omeprazole/ranitidine); 2 weeks after baseline||||Percentage||Standard Deviation|Mean
2626826|NCT01896557|Primary|Comparing Platelet Function of Patients on Dual Antiplatelet Therapy With ASA + Clopidogrel, Between the Groups Ranitidin and Omeprazole, After One Week of Randomized Treatment|One week after starting double-blind, double-dummy, randomized therapy with ranitidin or omeprazole on patients treated with DAPT, platelet function will be compared with the method VerifyNow, in P2Y12 Reactivity Units.|One week after randomized treatment exposure (omeprazole or ranitidine)||||P2Y12 Reactivity Units||Standard Deviation|Mean
2626827|NCT01896544|Secondary|Change in Immunological Profile 5 Days Following Supplementation With Cholecalciferol|Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Immunological profile at the onset of a suspected case of sepsis will be compared to the immunological profile between 5-9 days after supplementation with cholecalciferol or placebo. To assess the immunological profile, we will measure serum hsCRP.|Patients will be followed between the onset of suspected sepsis and for an average duration of 90 days||||mg/L||Inter-Quartile Range|Median
2626828|NCT01896544|Secondary|Incidence of Infection-related Complications Within 90 Days From the Onset of a Suspected Case of Sepsis|"Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. The incidence of infection-related complications will be assessed between the onset of suspected sepsis and 80-100 days after supplementation with cholecalciferol or placebo. To assess the incidence of infection-related complications, we will measure rates of:~1) 30 day hospital readmission; and 2) 30 day mortality."|Patients will be followed between the onset of suspected sepsis and for an average duration of 90 days||||participants|||Number
2626829|NCT01896544|Secondary|Incidence of Infection-related Complications Within 90 Days From the Onset of a Suspected Case of Sepsis|Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. The incidence of infection-related complications will be assessed between the onset of suspected sepsis and 80-100 days after supplementation with cholecalciferol or placebo. To assess the incidence of infection-related complications, we will measure rates of: 1) ICU length of stay; and 2) hospital length of stay|Patients will be followed between the onset of suspected sepsis and for an average duration of 90 days||||days||Inter-Quartile Range|Mean
2626830|NCT01896544|Secondary|Change in Immunological Profile 5 Days Following Supplementation With Cholecalciferol|Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Immunological profile at the onset of a suspected case of sepsis will be compared to the immunological profile between 5-9 days after supplementation with cholecalciferol or placebo. To assess the immunological profile, we will measure serum LL-37.|Patients will be followed between the onset of suspected sepsis and for an average duration of 7 days||||ng/mL||Inter-Quartile Range|Median
2626831|NCT01896544|Primary|Change in Vitamin D Status 5 Days Following Supplementation With Cholecalciferol|Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Vitamin D status at the onset of a suspected case of sepsis will be compared to vitamin D status between 5-9 days after supplementation with cholecalciferol or placebo. To assess vitamin D status, we will measure serum and urine: 1) 25-hydroxyvitamin D; 2) 1,25-dihydroxyvitamin D; 3) 24,25-dihydroxyvitamin D; 4) Fibroblast growth factor 23; 5) Vitamin D binding protein; 6) LL-37; 7) Parathyroid hormone; 8) Albumin; 9) Calcium; and 10) Phosphorus levels.|Patients will be followed between the onset of suspected sepsis and for an average duration of 7 days||||ng/mL||Inter-Quartile Range|Median
2626832|NCT01896297|Primary|Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose|Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss)|2 hours after the last drug administration, on day 8|PKS. Analysis includes patients with available data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2626833|NCT01896297|Primary|Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose|Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) taken at approximately 12 hours after the last dose (trough).|Immediately before the last drug administration, on day 8|Pharmacokinetic (PK) set (PKS) which included all patients in the treated set with analyzable data in at least one observation for at least one primary endpoint without important protocol violations relevant to the evaluation of PK. Analysis includes patients with available data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2626834|NCT01896232|Secondary|Mean Number of Episodes of Vomiting Per Week in the First 8 Weeks|"The number of vomiting episodes was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asks participants on a daily basis how many times they vomited in the past 24 hours. The number of episodes in a week is the sum of all reported daily episodes in the week.~For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis."|First 8 weeks|Full analysis set with available data. For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.|||vomiting episodes per week||Standard Error|Least Squares Mean
2626835|NCT01896232|Secondary|Mean Severity of Nausea in the First 8 Weeks|Severity of nausea was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asked participants to rate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined). For each participant, the mean severity of nausea was calculated by averaging all available daily severities (including zeroes) reported in the first 8 weeks.|First 8 weeks|Full analysis set with available data|||units on a scale||Standard Error|Least Squares Mean
2626836|NCT01896232|Secondary|Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase||Efficacy assessment phase (weeks 20 - 27)|Full analysis set; participants with no phosphorus assessments during the EAP were considered non-responders.|||percentage of participants|||Number
2626837|NCT01896232|Secondary|Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (weeks 20 - 27)|Full analysis set with available data.|||percent change||Standard Error|Mean
2626838|NCT01896232|Secondary|Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks|Participants completed the Nausea/Vomiting Symptom Assessment (NVSA) questionnaire daily. This questionnaire asked participants to indicate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined) and if they had vomited in the past 24 hours. A day of vomiting or nausea was defined as those where the severity of nausea score was > 0 or where the episodes of vomiting score was > 0.|First 8 weeks|Full analysis set with available data. For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.|||days of vomiting or nausea per week||Standard Error|Least Squares Mean
2626839|NCT01896232|Secondary|Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP (ie, non-responder imputation).|||percentage of participants|||Number
2626840|NCT01896232|Secondary|Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Weeks 20 to 27, inclusive).|Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP (ie, non-responder imputation).|||percentage of participants|||Number
2626841|NCT01896232|Primary|Percentage of Participants With > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis||Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).|Full analysis set participants with PTH data during the EAP|||percentage of participants|||Number
2626842|NCT01896206|Primary|The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP.|To avoid biasing the data, the absolute, not directional, difference was used. For example, if the reading from the CNAP device was 10 mmHg above or below the reading from the AC, a value of 10 mmHg was used, not -10 or +10 mmHg.|Participants will be followed for the duration of surgery, an expected average of 2 hours.|The initial study cohort included 21 patients; however, the finger cuff was expired in 1 patient, resulting in no data collection, and the data from 2 other patients were lost in the download to the electronic medical record system.|||mmHg||Standard Deviation|Mean
2626843|NCT01896193|Secondary|Percentage of Participants Experiencing Virologic Relapse|Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.|Up to Posttreatment Week 12|Full Analysis Set|||percentage of participants|||Number
2626844|NCT01896193|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
2626845|NCT01896193|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
2626846|NCT01896193|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.|Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug|||percentage of participants|||Number
2626847|NCT01896193|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 1 or 3 HCV infection who were randomized and received at least one dose of study drug|||percentage of participants|||Number
2626857|NCT01896115|Secondary|Resting Tremor Severity - Single Contact vs. Steering|Resting tremor was measured by a motion sensor system (Kinesia System) while either using a single contact or steering current between two contacts. Stimulation was at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).|Day 1 programming visit|The 24 patients reported here are a separate population from the 16 patients who were enrolled for primary endpoint analysis (40 total patients).|||units on a scale||Standard Deviation|Mean
2637572|NCT01780922|Primary|C-Reactive Protein (CRP) Concentrations in Plamsa||0, 2, 4, 8, 24 h||||ug/mL||Standard Error|Mean
2626848|NCT01896128|Secondary|9-Hole Peg Test|"9 HOLE PEG TEST~Administered by asking the client to take the pegs from a container, one by one, and place them into the holes on the board, as quickly as possible~Participants must then remove the pegs from the holes, one by one, and replace them back into the container~The board should be placed at the client's midline, with the container holding the pegs oriented towards the hand being tested~Only the hand being evaluated should perform the test~Hand not being evaluated is permitted to hold the edge of the board in order to provide stability~Scores are based on the time taken to complete the test activity, recorded in seconds~Alternative scoring - the number of pegs placed in 50 or 100 seconds can be recorded. In this case, results are expressed as the number of pegs placed per second~Stopwatch should be started from the moment the participant touches the first peg until the moment the last peg hits the container"|Baseline & Day 100||||Seconds||Standard Error|Mean
2626849|NCT01896128|Secondary|NIH Stroke Scale (NIHSS)|"The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0 Score.~Stroke severity 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke"|Baseline Day 100||||units on a scale||Standard Error|Mean
2626850|NCT01896128|Secondary|Timed 3-Minute Walk Test From Baseline to Day 100|"The 3MWT is a simple measure of the distance a person can walk in three minutes. Rest breaks are allowed if needed. The person is encouraged to walk as fast as they can, safely, for two minutes. Walking aids can be used as needed e.g. for elderly people with a record made of walking aid used.A clear course such as a hallway with cones or similar to mark an approximately 15m out and back course[8], stopwatch, pen and paper or a device to record distance walked."|Day 1, Day 100||||feet||Standard Deviation|Mean
2626851|NCT01896128|Secondary|Change in Functional Independence Measure (FIM) From Baseline to Day 100|"The FIM is used by health care practitioners to assess and grade the functional status of a person based on the level of assistance he or she requires.~The motor subscale includes:Eating,Grooming,BathingDressing, upper body,Dressing, lower body Toileting Bladder management Bowel management Transfers - bed/chair/wheelchairTransfers - toiletTransfers - bath/showerWalk/wheelchairStairs The cognition subscale includes:Comprehension ExpressionSocial interaction Problem solvingMemory Each item is scored on a 7 point ordinal scale, ranging from a score of 1(worse) to a score of 7(better). The total score for the FIM motor subscale (the sum of motor subscale ) will be a value between 13 and 91.The total score for the FIM cognition subscale (the sum of the individual cognition subscale items) will be a value between 5(worse outcome) & 35(best outcome).The total score for the FIM instrument (the sum of subscale scores) will be a value between 18(worse outcome) & 126 (best outcome)"|Day 100||||units on a scale||Standard Deviation|Mean
2626852|NCT01896128|Primary|Change in Fugl-Meyer Assessment of Sensorimotor Function From Baseline to Day 100|"Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had a stroke.The maximum possible score in Fugl-Meyer scale is 226, which corresponds to full sensory-motor recovery. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively. The five domains assessed by Fugl-Meyer scale are:~Motor function (Maximum score in upper limb = 66;Maximum score in lower limb = 34)~Sensory function (Maximum score = 24)~Balance (Maximum score = 14)~Range of motion of joints (Maximum score = 44)~Joint pain (Maximum score = 44)"|Baseline to Day 100|data available for participants who completed the study|||units on a scale||Standard Deviation|Mean
2626853|NCT01896115|Other Pre-specified|Finger Tapping Amplitude - Pulse Width and Dorsal-Ventral Steering|Severity of finger-tapping bradykinesia was measured by a motion sensor system (Kinesia System) at 60 µs, 30 µs, and dorsal and ventral current steering settings. Stimulation was at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).|Day 1 programming visit||||units on a scale||Standard Deviation|Mean
2626854|NCT01896115|Other Pre-specified|Resting Tremor Severity - Pulse Width and Dorsal-Ventral Steering|Resting tremor was measured by a motion sensor system (Kinesia System) at 60 µs, 30 µs, and current steering settings, at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).|Day 1 programming Visit||||units on a scale||Standard Deviation|Mean
2626855|NCT01896115|Other Pre-specified|Dorsal-Ventral Current Steering Therapeutic Window|The therapeutic window refers to the range of stimulus amplitudes that provide a therapeutic effect without side effects. In other words, this measure reports the stimulus amplitude difference between the full rigidity control threshold and the first stimulation induced side effect threshold at current steering settings (current divided 50% between adjacent electrodes).|Day 1 programming visit|The therapeutic window of short pulse widths vs. conventional pulse widths was a primary outcome measure and is reported as such in another section of this report.|||mA||Standard Deviation|Mean
2626856|NCT01896115|Secondary|Finger Tapping Amplitude - Single Contact vs. Steering|Severity of finger-tapping bradykinesia was measured by a motion sensor system (Kinesia System) when either using a single contact or steering current between two contacts. Stimulation was at amplitudes defined as the therapeutic threshold for rigidity. The Kinesia System was worn by patients to measure motion parameters including linear acceleration and angular velocity during different tasks, then provided an output score on a scale of 0 (no symptoms) to 4 (severe symptoms).|Day 1 programming visit|The 24 patients reported here are a separate population from the 16 patients who were enrolled for primary endpoint analysis (40 total patients).|||units on a scale||Standard Deviation|Mean
2627246|NCT01892267|Primary|Number of Participants With PEG-J Tube Migration|Number of participants in whom migration was assessed by X-ray at 4 weeks post-intervention.|From date of placement up to 4 weeks||||participants|||Number
2626858|NCT01896115|Secondary|Side Effect Thresholds - Single Contact vs. Steering|This endpoint determined how much current (mA) could be applied before side effects appeared when using 60 microsecond pulse widths. Values were obtained for when current was delivered through a single contact or divided between two contacts (steering).|Day 1 programming visit|The 24 patients reported here are a separate population from the 16 patients who were enrolled for primary endpoint analysis (40 total patients).|||mA||Standard Deviation|Mean
2626859|NCT01896115|Primary|Unified Parkinson's Disease Rating Scale III|"The Unified Parkinson's Disease Rating Scale (UPDRS) has four sections (I-IV) that ask patients to rate aspects of their mental state including mood (I), aspects of daily activities (II), aspects of motor function (III), and complications of treatment (IV). Here, we ask subjects to rate their motor function (UPDRS III) following interventions with 30 µs and 60 µs pulse width DBS settings.~The UPDRS III scale has 14 categories including speech, facial expression, tremor at rest, action tremor, rigidity, finger tapping ability, ability to open and close hands, ability to rapidly alternate hand movements, leg agility, ability to rise from a chair, posture, gait, response to postural displacement (e.g., push), and bradykinesia. Patients rate each of these categories from 0 to 4, with 0 being normal function and 4 being the worst. Categories assessing appendages are rated for both left and right sides, allowing a maximum score (worst outcome) of 108."|Day 1 programming visit|All subjects were analyzed at both pulse widths. Primary outcomes were only intended to be assessed for different pulse widths and not current steering.|||UPDRS III score||Standard Deviation|Mean
2626860|NCT01896115|Primary|Therapeutic Window|The therapeutic window refers to the range of stimulus amplitudes that provide a therapeutic effect without side effects. In other words, it is the amplitude difference between the first stimulation-induced side effect threshold (e.g., eye deviation, muscle contraction, and speech) and full rigidity control threshold at 60 µs and 30 µs pulse width DBS settings.|Day 1 programming visit|"Therapeutic window for current steering settings was not a primary outcome measure but is described later as an Other outcome measure."|||mA||Standard Deviation|Mean
2626861|NCT01896050|Secondary|Association Between Baseline Body Mass Index and Discontinuation of Aromatase Inhibitor Therapy Within the First 12 Months|Associations between baseline BMI and whether or not aromatase inhibitor-treated patients discontinued treatment by 12 months. In the original statistical analysis plan, it was only intended to examine the association with aromatase inhibitor-treated patients, and not tamoxifen-treated patients. The numbers below reflect the number of patients in each group who discontinued initial endocrine therapy within the first 12 months of treatment|baseline and 12 months||||participants|||Number
2626862|NCT01896050|Secondary|Effect of Medication on Change in Grip Strength|Effect of either aromatase inhibitor or tamoxifen therapy on change in grip strength between baseline and 12 months|baseline and 12 months||||percent change||Standard Deviation|Mean
2626863|NCT01896050|Primary|Effect of Change in Body Mass Index on Change in Grip Strength With Aromatase Inhibitor Therapy|Change in BMI between baseline and 12 months of endocrine therapy|baseline and 12 months|These data only include patients who completed a full 12 months of treatment with either an aromatase inhibitor or tamoxifen and had grip strength data at both baseline and 12 months. Patients could have switched from one aromatase inhibitor to another. Those patients who discontinued treatment prior to the 12 month period were excluded.|||kg/m^2||Standard Deviation|Mean
2626864|NCT01895972|Primary|Clinical Safety|Ocular adverse events reported over one year of once daily dosing of latanoprostene bunod 0.024%. Below is the percentage of subjects with >/=1 ocular AE Specifics of AEs are captured in the AE section.|1 year|Safety Population (Study Eye)|||Participants|||Count of Participants
2626865|NCT01895972|Primary|Change From Baseline in Intraocular Pressure|Change from baseline in intraocular pressure (IOP) following treatment with latanoprostene bunod 0.024% (instilled QD in the evening) with IOP assessed every 4 weeks from Week 4 to Week 52.|Baseline and week 4,8,12,16,20,24,28,32,36,40,44,48,52|Safety population|||mm Hg||Standard Deviation|Mean
2626866|NCT01895946|Secondary|Efficacy: Progression-free Survival (PFS)|PFS is defined as the time from randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the subject withdraws from randomised therapy or receives another anti-cancer therapy prior to progression. Subjects who have not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST assessment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions.|Assessed every 6 weeks up to 36 weeks|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.|||weeks||Inter-Quartile Range|Median
2626867|NCT01895946|Secondary|Efficacy: Target Lesion Size, Best Percentage Change From Baseline|"Tumour size is the sum of the longest diameters of the target lesions. Target lesions are measurable tumour lesions.~best percentage change in tumour size from baseline is the maximum reduction from baseline or the minimum increase from baseline in the absence of a reduction from baseline based on all post baseline assessments."|Assessed every 6 weeks up to 36 weeks|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.|||Percentage change from baseline||Standard Deviation|Mean
2626868|NCT01895946|Secondary|Efficacy: Target Lesion Size, Percentage Change From Baseline at Week 12|"Tumour size is the sum of the longest diameters of the target lesions. Target lesions are measurable tumour lesions.~The percentage change in target lesion tumour size at each week 12 for which data are available was obtained for each subject taking the difference between the sum of the target lesion at each week 12 and the sum of the target lesions at baseline divided by the sum of the target lesions at baseline multiplied by 100 (i.e. (week 12) - baseline)/baseline * 100)."|Week 12|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.|||Percentage change from baseline||Standard Deviation|Mean
2626869|NCT01895946|Secondary|Efficacy: Disease Control at Week 12|Disease control = confirmed complete response + confirmed partial response + stable disease at 12 weeks|Week 12|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.|||Participants|||Number
2627737|NCT01885910|Secondary|Pruritis|the pruritis severity scale ranges from 0 to 5 with 0 being no pruritis and 5 being the most extreme pruritis|every 4 weeks|participants with data|||units on a scale||Standard Deviation|Mean
2626870|NCT01895946|Secondary|Efficacy: Best Objective Response (BOR)|"Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 guidelines for measurable, non-measurable, target lesions (TLs) and non-target lesions (NTLs) and the objective tumour response criteria was used.~Categorisation of objective tumour response assessment was based on the RECIST 1.1 guidelines for response: CR (complete response, efined as disappearance of all target lesions), PR (partial response, defined as >=30% decrease in the sum of the longest diameter of target lesions), SD (stable disease, defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression) and PD (progression of disease, defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion). BOR was the best overall response observed across the study and up to 36 weeks. Number of subjects with response (CR or PR) is described."|Assessed every 6 weeks, up to 36 weeks|Modified intent-to-treat analysis set: all patients who received at least one dose of study treatment with a baseline tumour assessment.|||Participants|||Number
2626871|NCT01895946|Primary|Ratio of AUCss for Day 4 to Day 11|"The actual sampling times were used in the parameter calculations and PK parameters were derived using standard non-compartmental methods.~Following the twice daily dosing in Cycle 1 at Day 4 and 11 for both the formulation switch and food effect investigations, the following PK parameters have been determined:~Css max, tss max, Css min, area under the plasma concentration-time curve from zero to the end of the dosing interval (AUCss) and CLss/F.~Css max, tss max were determined by inspection of the concentration-time profiles. AUCss was calculated using the linear up / log down trapezoidal rule. CLss/F was determined from the ratio of dose/AUCss.~Ratio of AUCss for Day 4 to Day 11 have been derived."|Day 4 and Day 11|All patients who provided concentration-time data for AZD5363 for both capsule and tablet administration (Part A) or for both fed and fasted treatments and who were compliant with the standard dietary and evaluability requirements (Part B) were included in PK analysis set.|||Ratio||90% Confidence Interval|Geometric Mean
2626872|NCT01895946|Primary|Ratio of Css,Max for Day 4 to Day 11|"The actual sampling times were used in the pharmacokinetics (PK) parameter calculations and PK parameters were derived using standard non-compartmental methods.~Following the twice daily dosing in Cycle 1 at Day 4 and 11 for both the formulation switch and food effect investigations, the following PK parameters have been determined:~Maximum plasma concentration at steady state (Css max), time to Css,max (tss max), minimum plasma concentration at steady state (Css min), area under the plasma concentration-time curve from zero to the end of the dosing interval (AUCss) and apparent clearance (CLss/F).~Css max, tss max were determined by inspection of the concentration-time profiles. AUCss was calculated using the linear up / log down trapezoidal rule. CLss/F was determined from the ratio of dose/AUCss.~Ratio of Css,max for Day 4 to Day 11 have been derived."|Day 4 and Day 11|All patients who provided concentration-time data for AZD5363 for both capsule and tablet administration (Part A) or for both fed and fasted treatments and who were compliant with the standard dietary and evaluability requirements (Part B) were included in PK analysis set.|||Ratio||90% Confidence Interval|Geometric Mean
2626873|NCT01895647|Other Pre-specified|Inflammatory Cytokine Change|Serum interleukin(IL)-1B, IL-6, IL-8, IL-10, IL-15 and tumor necrosis factor(TNF)-alpha will be measured before/after first section of EMS, and after fifth EMS section.|First 1 week.|The data was not completed because undetected IL-15 in first two samples. No data collection was performed for further samples.||||||
2626874|NCT01895647|Secondary|Muscle Strength Improvement|muscle power measurement by hand grip digital dynamometer every 2 days|21 days|The measurement cannot be collected because of the patients' drowsiness or incorporation.||||||
2626875|NCT01895647|Primary|Ventilator-dependant Days|Patient days on mechanical ventilator ( Our National Health Insurance provide 21 days for acute intensive care at most)|21 days||||days||Inter-Quartile Range|Median
2626876|NCT01895634|Secondary|All Cause Mortality||90 days post-procedure||||participants|||Number
2626877|NCT01895634|Secondary|Proportion of Patients With Symptomatic and Asymptomatic Intracranial Hemorrhage (ICH)||24-hour post procedure|Missing value was not be imputed (1 missing subject was because of the death within 24 hours)|||participants|||Number
2626878|NCT01895634|Secondary|Neurological Outcome: Proportion of mRS 0-2 at 90 Days Post Procedure|"The Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death, or similar, as accurate."|90 days post procedure|Missing value was not be imputed (1 missing subject was because of the missing data at 90 days by subject IC withdrawal)|||participants|||Number
2626879|NCT01895634|Secondary|Proportion of Subject Who Have Clot Migration/Embolization||immediately post procedure||||participants|||Number
2626880|NCT01895634|Primary|Proportion of Patients Who Have Recanalization|Proportion of subjects who had recanalization, TICI 2a or better|immediately post procedure||||participants|||Number
2626881|NCT01895608|Secondary|Change Scores in Activities-specific Balance-related Confidence|Subjects' decreased confidence in a variety of situations will be measured using the Activities-specific Balance Confidence scale which has good test-retest reliability. Sixteen activities are each assessed on a scale ranging from 0 to 100, where higher scores indicate greater confidence in performing the activity. Item scores are averaged to arrive at a final score, where average scores <67% indicate a greater fall risk.|baseline and 6 weeks||||overall percentage of confidence||Standard Deviation|Mean
2626882|NCT01895608|Secondary|Change Scores in Preferred Gait Speed|Subjects walk at their preferred speed and time to walk 6 m is recorded.|baseline and 6 weeks||||meters per second||Standard Deviation|Mean
2626883|NCT01895608|Secondary|Change Scores in Sensory Organization Test (SOT)|"SOT is organized into a series of 6 conditions of increasing difficulty: 3 involve a firm surface with eyes open, eyes closed and with vision sway-referenced and 3 involve a sway-referenced surface with eyes open, eyes closed, and with vision sway-referenced. SOT has good reliability and differentiates fallers and nonfallers.~The SOT composite score is used for statistical analysis with a maximum score of 100 (indicating perfect stability) and a minimum score of 0 (indicating severe instability). Higher scores indicate better performance (i.e., greater postural stability) and SOT composite scores less than 38 out of 100 indicate fall risk."|baseline and 6 weeks||||units on a scale||Standard Deviation|Mean
2627396|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Day 2|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
2626884|NCT01895608|Secondary|Change Scores in Dynamic Gait Index|"Dynamic Gait Index (DGI) assesses gait under 8 conditions and has excellent interrater as well as test-retest reliability.~Each of the 8 conditions is scored on a scale from 0 (indicating severe impairment) to 3 (indicating normal ability). The total score is used for statistical analysis with a maximum score of 24 and a minimum score of 0 with a higher score indicating better performance. A total DGI score less than 20 out of 24 indicates fall risk."|baseline and 6 weeks||||units on a scale||Standard Deviation|Mean
2626885|NCT01895608|Secondary|Change Scores in Walk While Talk Test With Verbal Fluency Task|The walk while talk (WWT) test involves walking at preferred speed while performing a verbal fluency task.|baseline and 6 weeks||||seconds||Standard Deviation|Mean
2626886|NCT01895608|Primary|Change Scores in Timed up and go With Cognitive Task|Timed up and go test (TUG) has three conditions: no secondary task (TUG), cognitive (TUGc) and manual dual-tasks (TUG-m). Time to complete the task with the cognitive task was recorded as a primary outcome measure. Time greater than 15 s for TUG-c indicates impaired dual-task ability.|baseline and 6 weeks||||seconds||Standard Deviation|Mean
2626887|NCT01895543|Secondary|Change From Baseline in EuroQol Group Visual Analog Scale (EQ-VAS) Score|"The EQ VAS presents the participant's self-evaluated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. This scale is numbered from 0 to 100, where '100' means best health you can imagine and '0' means worst health you can imagine. The participant simply mark an 'X' on the scale to indicate how his/her health is TODAY and mention the same number in a box provided."|At Week 12, 24, 36 and 52|Safety Analysis Set|||Unit on a scale||Standard Deviation|Mean
2626888|NCT01895543|Secondary|Change From Baseline in EuroQol Group 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) Scores|EQ-5D-5L is a standardised measure of health status developed to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L descriptive system comprises the following five dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels (1-5 denotes): no problems, slight problems, moderate problems, severe problems, and extreme problems, respectively. A unique health state was defined by combining 1 level from each of the 5 dimensions. Each health state was converted into a single EQ-5D-5L index value. The index values are country specific and values specified for United Kingdom (UK) were used for this study. The index value range for UK lies between -0.594 - 1.000. A positive index value represents better health status while the negative value represents poor health status.|At Week 12, 24, 36 and 52|Safety Analysis Set|||Unit on a scale||Standard Deviation|Mean
2626889|NCT01895543|Primary|Number of Patients Using Concomitant Medications|The concomitant medications details were collected throughout the trial at all visits. Data were obtained at scheduled or unscheduled trial visits based on information provided spontaneously by the patient or as a result of questioning the patient.|For the overall 52-week Treatment Period|Safety Analysis Set|||Patients|||Number
2626890|NCT01895543|Secondary|Change From Baseline in Patient Assessment of Constipation - Quality of Life (PAC-QOL): Overall Score|PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific QOL. The questionnaire is based on a 5-point Likert scale; ranging from 0 [none of the time or not at all] to 4 [all of the time or extremely]). A lower score indicates a better QOL. The PAC-QOL questionnaire is developed specifically for patients with constipation. PAC-QOL has four sub-scales: 'Worries and Concerns', 'Physical Discomfort', 'Psychosocial Discomfort', and 'Dissatisfaction'.|At Week 12, 24, 36 and 52|Safety Analysis Set|||Unit on a scale||Standard Deviation|Mean
2626891|NCT01895543|Secondary|Change From Baseline in Global Evaluation of Treatment Effectiveness|The treatment effectiveness score was measured on a 5-point scale (1: extremely effective, 2: quite a bit effective, 3: moderately effective, 4: little bit effective, 5: not at all effective).|At Week 12, 24, 36, and 52|Safety Analysis Set|||Unit on a scale||Standard Deviation|Mean
2626892|NCT01895543|Secondary|Change From Baseline in Global Evaluation of Constipation Severity|The constipation severity score was measured on a 5-point scale (1: none to 5: very severe).|At Week 12, 24, 36, and 52|Safety Analysis Set|||Unit on a scale||Standard Deviation|Mean
2626893|NCT01895543|Secondary|Use of Concomitant Over-the-counter (OTC) Laxatives|The use of OTC laxatives during the trial was assessed based upon the concomitant medication module of the electronic Case Report Form (eCRF).|For the overall 52-week Treatment Period|Safety Analysis Set|||Patients|||Number
2626894|NCT01895543|Primary|Incidence of Markedly Abnormal Changes in Body Weight and Vital Signs|Vital signs were measured at all visits and included blood pressure (BP: measured after the patient had been in a seated position for ≥3 minutes of rest), pulse, respiration rate, body temperature, and body weight.|For the overall 52-week Treatment Period|Safety Analysis Set|||Patients|||Number
2626895|NCT01895543|Primary|Incidence of Markedly Abnormal Changes in Electrocardiograms (ECGs)|A routine 12-lead ECG was performed at all visits. The ECG included heart rate, PR, QRS, and QT intervals assessment.|For the overall 52-week Treatment Period|Safety Analysis Set|||Patients|||Number
2626896|NCT01895543|Primary|Incidence of Markedly Abnormal Changes in Clinical Safety Laboratory Variables|Outcome measure include laboratory parameters from haematology, coagulation and clinical chemistry|For the overall 52-week Treatment Period|Safety Analysis Set|||Patients|||Number
2626897|NCT01895543|Primary|Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs)|The Investigator recorded all AEs throughout the trial from the time of obtaining informed consent till the last visit (i.e., Visit 6). Information on AE was collected at each visit. All AEs were recorded in AE log for each patient.|For the overall 52-week Treatment Period|Safety Analysis Set|||Patients|||Number
2626898|NCT01895452|Secondary|Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time|"The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients. Results indicate a change in CGI-S score from baseline to Day 365 based on the observed data. Change is calculated between the baseline visit and the subject's last visit in the treatment period."|Up to 12 months|The full analysis set consists of all subjects who received at least 1 dost of ALKS 9072 and had at least 1 postbaseline assessment of PANSS score after administration of ALKS 9072.|||units on a scale||Standard Deviation|Mean
2626899|NCT01895452|Secondary|Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time|This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and the subject's last visit in the treatment period.|Up to 12 months|The full analysis set consisted of all subjects who received at least 1 dose of ALKS 9072 and had at least 1 postbaseline assessment of PANSS total score after administration of ALKS 9072.|||units on a scale||Standard Deviation|Mean
2626900|NCT01895452|Primary|Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)|This measure includes all incidences, including those that occurred >5%.|Up to 12 months|Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.|||Participants|||Count of Participants
2626901|NCT01895361|Secondary|Patient Reported Outcome: Change From Baseline in Pain Severity/Pain Interference Domain From Brief Pain Inventory (BPI) Questionnaire|The BPI instrument was completed by the patients at pre-specified study visits prior to & during the Treatment & Follow-Up Evaluation Phases. Patients completed the brief pain inventory long-form, 1-week recall at the indicated pre-specified study visits. The BPI is a standardized self-reported questionnaire developed to provide information on the intensity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI also asks questions about pain relief, pain quality, & the patient's perception of the cause of pain. Since pain can be quite variable over a day, the BPI asks patients to rate their pain at the time of responding to the questionnaire (pain now), & also at its worst, least, & average over the previous week. The scorings for pain & interference have a range from 0 (no pain/no interference) to 10 (worst pain/complete interference). The BPI scoring manual was used to calculate scores for each domain.|Baseline, Day 15, Week 14, Week 26, Week 38, Week 52, and Week 58, up to 58 weeks|ITT population: The ITT population includes all randomized participants.|||score on a scale||Standard Deviation|Mean
2626902|NCT01895361|Secondary|Annual Rate of Acute Chest Syndrome Per Hodges-Lehmann Median|Acute Chest Syndrome (ACS) is defined on the basis of the finding of a new pulmonary infiltrate involving at least one complete lung segment that was consistent with alveolar consolidation, but excluding atelectasis (as indicated by chest X-ray). At least one of the following additional signs or symptoms needs to be present as well: a participant had to have reported chest pain, a temperature of more than 38.5oC, tachypnea, wheezing or cough.|One year|ITT population: The ITT population includes all randomized participants.|||accute chest syndrome per year||Full Range|Median
2626903|NCT01895361|Secondary|Annual Rate of Uncomplicated Sickle Cell-related Pain Crisis Per Hodges-Lehmann Median|Uncomplicated SCPC is defined as an acute episode of pain with no known cause for pain other than a vasoocclusive event; requiring a visit to a medical facility; and requiring treatment with a parenteral or oral narcotic (including opiates), or parenteral NSAIDs; but is NOT classified as an acute chest syndrome, hepatic sequestration, splenic sequestration or priapism.|Up to one year|ITT population: The ITT population includes all randomized participants.|||Uncomplicated SCPC per year||Full Range|Median
2626904|NCT01895361|Secondary|Time to Second Sickle Cell-related Pain Crisis|Time to second SCPC is defined as months from randomization to second SCPC. A patient with less than two SCPC before withdrawal or completion of the study is considered censored at the time of the end date. End date is defined as the last dose plus 14 days. For patients never dosed, the end date is the end of study date.|Up to one year|ITT population: The ITT population includes all randomized participants.|||months||Inter-Quartile Range|Median
2626905|NCT01895361|Secondary|Time to First Sickle Cell-related Pain Crisis|Time to first SCPC is defined as months from randomization to first SCPC. A participant without SCPC before withdrawal or completion of the study is considered censored at the time of the end date. End date is defined as the last dose plus 14 days. For participants never dosed, the end date is the end of study date.|Up to one year|ITT population: The ITT population includes all randomized participants.|||months||Inter-Quartile Range|Median
2626906|NCT01895361|Secondary|Annual Rate of Days Hospitalized (Key Secondary Endpoint) Per Hodges-Lehmann Median|The annual rate of days hospitalized was calculated as the number of days hospitalized multiplied by 365 divided by the end date minus the date of randomization plus one where the end date is defined as the last dose date plus 14 days (for subjects never dosed, the end date equaled the end of study date, which was the last site contact for these patients).|One year|ITT: The ITT population includes all randomized patients.|||Days hospitalized per year||Full Range|Median
2626907|NCT01895361|Primary|Annual Rate of Sickle Cell-related Pain Crises (SCPC) - Per Standard Median|An SCPC is defined as an acute episode of pain with no other medically determined cause than a vasoocclusive event that requires a medical facility visit and treatment with oral or parenteral narcotics, or parenteral non-steroidal anti-inflammatory drugs. The annual rate of SCPC is defined as the total number of pain crises for a patient occurring from the date of randomization to the end date multiplied by 365 divided by the number of days during that same time period. End date is defined as the last dose date plus 14 days. For participants never dosed, the end date was the end of study date. This calculation accounts for early dropouts or lost to follow-up by extrapolating the SCPC rate of every participant to one year.|One year|Intent-to-Treat (ITT) population: The ITT population includes all randomized participants.|||SCPC per year||Full Range|Median
2626908|NCT01895361|Primary|Annual Rate of Sickle Cell-related Pain Crises (SCPC) Per Hodges-Lehmann Median|An SCPC is defined as an acute episode of pain with no other medically determined cause than a vasoocclusive event that requires a medical facility visit and treatment with oral or parenteral narcotics, or parenteral non-steroidal anti-inflammatory drugs. The annual rate of SCPC is defined as the total number of pain crises for a patient occurring from the date of randomization to the end date multiplied by 365 divided by the number of days during that same time period. End date is defined as the last dose date plus 14 days. For participants never dosed, the end date was the end of study date. This calculation accounts for early dropouts or lost to follow-up by extrapolating the SCPC rate of every participant to one year.|One year|Intent-to-Treat (ITT) population: The ITT population includes all randomized participants.|||SCPC per year||Full Range|Median
2627385|NCT01890694|Secondary|Neutrophil Function [Results From the Assay of Neutrophils]|Improved neutrophil function from baseline|Day 1 to Post-discharge (6 months)|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
2626909|NCT01895335|Secondary|Expanded Disability Status Scale (EDSS) Score at Baseline and Week 48|EDSS is a method of quantifying disability in MS participants and monitoring changes in the level of disability over time. EDSS quantifies disability in 8 functional systems: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other. EDSS scale ranges from 0 to 10 in 0.5 unit increments that represents higher levels of disability. EDSS score 1.0 to 4.5 refers to people with MS who are fully ambulatory; EDSS score 5.0 to 9.5 refers to impairment to ambulation; EDSS score 10 refers to death due to MS.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. Here, ‘n’ signifies number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
2626910|NCT01895335|Secondary|Change From Baseline in Stern Leisure Activity Scale at Week 48|The Stern Leisure Activity Scale is a self-reported scale that consists of 13 questions assessing the participant's participation in leisure activities during the preceding month. One point is given for participation in each of the 13 activities and an aggregate score (range from 0 to 13) is obtained. ≤ 6 score is considered as low leisure activity and > 6 score as high leisure activity.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.|||units on a scale||Standard Deviation|Mean
2626911|NCT01895335|Secondary|Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Score at Week 48|The MusiQoL is a quality of life questionnaire that consists of 31 questions, divided into 9 dimensions: activities of daily living, physiological well-being, symptoms, relationship with friends, relationship with family, sentimental and sexual life, coping, rejection and relationship with healthcare system. All the 9 dimension scores and the global scores are linearly transformed and standardized on 0 (worst outcome) -100 (best outcome) scale. Higher scores represents higher quality of life.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.|||units on a scale||Standard Deviation|Mean
2626912|NCT01895335|Secondary|Duration of Teriflunomide Treatment Exposure|Duration of exposure was defined as last dose date - first dose date + 1 day, regardless of unplanned intermittent discontinuations and regardless of dosage administered (14 mg or 7 mg).|Baseline up to end of treatment (up to Week 48)|Analysis was performed on Safety population.|||Days||Standard Deviation|Mean
2626913|NCT01895335|Secondary|Percentage of Participants With Treatment Compliance of ≥80% During the Study Treatment Period|Percentage of compliance for a participant was defined as the number of days that the participant was compliant (1 tablet/day) divided by the exposure duration in days (from the first dose administration to the last dose administration) times 100.|Baseline up to end of treatment (up to Week 48)|Analysis was performed on Safety population.|||percentage of participants|||Number
2626914|NCT01895335|Secondary|Overview of Adverse Events (AEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during from first study drug intake up to 112 days after last intake for participant with no accelerated elimination procedure (AEP) or to last AEP follow up visit for participants with AEP. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|From first study drug intake up to 112 days after last intake for participant with no AEP or to last AEP follow up visit for participants with AEP|Safety Population that included all treated participants who received at least 1 dose or part of a dose of IMP.|||percentage of participants|||Number
2626915|NCT01895335|Secondary|Change From Baseline in Cognition Measured by Symbol Digit Modalities Test (SDMT) Score at Week 48|SDMT measures the time to pair abstract symbols with specific numbers. It is a simple substitution task that gives the examinee 90 seconds to pair specific numbers with given geometric figures as a measure for screening cognitive impairment. The score is computed as a ratio of number of correct responses divided by the total number of responses. The test score range from 0 (worst outcome) to 1 (best outcome). Higher scores are indicative of better cognition function.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.|||units on a scale||Standard Deviation|Mean
2626916|NCT01895335|Secondary|Time to Relapse: Kaplan-Meier Estimates of the Probability of Treated Relapse at Week 4, Week 24 and Week 48|A treated relapse was defined as a relapse treated by a systemic corticosteroid treatment or by another DMT. If a participant had no treated relapse before treatment discontinuation/completion, then the participant was considered as free of treated relapse until the date of treatment discontinuation/completion. Only treated relapse occurred during the treatment period (first drug administration to last drug administration) were considered for analysis. Kaplan-Meier method was used to estimate the probability of treated MS relapse at 4, 24 and 48 weeks.|Baseline up to end of treatment (up to Week 48)|Analysis was performed on Efficacy population.|||percent probability of treated relapse||95% Confidence Interval|Number
2626917|NCT01895335|Secondary|Annualized Treated Relapse Rate|Annualized treated relapse rate was defined as the total number of treated relapses during the study treatment period divided by the total number participants-years of treatment. Only events occurred during the treatment period (first drug administration to last drug administration) were considered for analysis.|Baseline up to end of treatment (up to Week 48)|Analysis was performed on Efficacy population.|||relapses per patient-year|||Number
2626932|NCT01895101|Secondary|Total Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period)|The amount of red blood cell transfusions the patient receive pre, peri and postoperatively during their stay in the hospital.|participants will be followed for the duration of ICU stay, an expected average of 2 days/ And participants will be followed for the duration of hospital stay, an expected average of 3 weeks||||IU||Standard Deviation|Mean
2626969|NCT01894906|Secondary|Dialysate InFlow Iron Concentration|Dialysate inflow iron concentration was calculated for each treatment group at t = 0, 0.5, 1, 2, 3, and 4 hours.|4 hours|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.|||micrograms/L||Standard Deviation|Mean
2626918|NCT01895335|Secondary|Change From Baseline in Multiple Sclerosis Performance Scale (MSPS) Score at Week 24 and Week 48|MSPS was a self-reported measure for MS associated disability in which participants were asked to indicate the category that best described their condition during the past month on the following 8 subscales: mobility, hand function, vision, fatigue, cognitive symptoms, bladder/bowel, sensory symptoms and spasticity symptoms. MSPS used a single question to assess each of 8 subscales. All of the subscales ranged from 0= normal to 5= total disability, except mobility subscale which ranged from 0= normal to 6=total disability. Total MSPS score ranged from 0 =normal to 41=greater disability, where higher score reflected greater disability.|Baseline, Week 24, Week 48|Analysis was performed on Efficacy population. Here, ‘n’ signifies number of participants with available data at specified time points.|||units on a scale||Standard Deviation|Mean
2626919|NCT01895335|Secondary|Change From Baseline in Disease Progression Using Patient Determined Disease Steps (PDDS) Score at Week 48|PDDS scale developed to assess the disability in Multiple Sclerosis (MS) participants and in assessing disease progression that focuses mainly on how participants walk. PDDS scale consists of 0 = normal; 1 = mild disability; 2 = moderate disability; 3 = gait disability; 4 = early cane; 5 = late cane; 6 = bilateral support; 7 = wheelchair/scooter and 8 = bedridden. A higher score represented higher level of disability.|Baseline, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point.|||units on a scale||Standard Deviation|Mean
2626920|NCT01895335|Secondary|Change From Week 4 in TSQM Scores in Naïve Participants to Week 48|TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction.|Week 4, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. Here, ‘n’ signifies number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
2626921|NCT01895335|Secondary|Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48|TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions: 12-14). For each of the 4 domains the scores of the corresponding items were added based on an algorithm to create a score of 0 to 100. Higher scores indicated greater satisfaction .|Baseline, Week 4, Week 48|Analysis was performed on Efficacy population. Number of participants analyzed=participants with available data at specified time point. Here, ‘n’ signifies number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
2626922|NCT01895335|Primary|Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 - Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48|"TSQM version 1.4 is a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14).~Primary outcome was the global satisfaction score. The score of the corresponding item was added based on the algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain."|Week 48|Efficacy population that included all treated participants. Number of participants analyzed = participants with available data at specified time point.|||units on a scale||Standard Deviation|Mean
2626923|NCT01895322|Secondary|Percent Change in Body Weight|Percent change in body weight from baseline during the repeated-administration period(For five days).|100%*<Body weight on day13 minus Body weight at baseline (day9)/Body weight at baseline(day9)>||||Percentage||Standard Deviation|Mean
2626924|NCT01895322|Primary|Percent Change in Daily Urine Volume From Baseline|Percent change in daily urine volume from baseline during the repeated-administration period (For five days).|100%*<Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period/Urine Volume at baseline(day9) on the repeated-administration period>||||Percentage||Standard Deviation|Mean
2626925|NCT01895322|Secondary|Change in Body Weight From Baseline|Change in body weight from baseline during the repeated-administration period(For five days).|Body weight on day13 minus Body weight at baseline(day9) on the repeated-administration period||||kg||Standard Deviation|Mean
2626926|NCT01895322|Primary|Change in Daily Urine Volume From Baseline|Change in daily urine volume from baseline during the repeated-administration period (For five days).|Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period.||||mL||Standard Deviation|Mean
2626927|NCT01895309|Secondary|American College of Rheumatology 50% Response Criteria (ACR50)||Week 24, Week 52||||percentage of participants|||Number
2626928|NCT01895309|Secondary|ACR20||Week 52||||percentage of participants|||Number
2626929|NCT01895309|Primary|American College of Rheumatology 20% Response Criteria (ACR20)||Week 24||||percentage of participants|||Number
2626930|NCT01895270|Primary|Change Over Time in Illicit Opioid Use Via Urine Toxicology Screens During Buprenorphine Taper (Wks 5-6)|Illicit results via urine toxicology screens for heroin and several opioids will be measured thrice weekly during the taper|thrice weekly for approx 2 weeks (taper)|Urine data of subjects that received at least one dose of isradipine and returned for at least one visit in which a urine drug screen was obtained were included in the analysis|||opioid-positive urine|Urine drug screen results|Standard Error|Least Squares Mean
2626931|NCT01895127|Primary|Percent Change in Estimated Glomerular Filtration (eGFR) Rate|Percent change in eGFR rate at 3 months post-treatment using the modified Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.|Month 3|1 subject in the SOC arm received rescue therapy, per protocol, with eculizumab following PP/IVIg. 1 subject in the Soliris arm received SOC therapy (PP/IVIg) following completion of Soliris treatment period. Both of these subjects received both SOC and Soliris treatment prior to Month 3 protocol biopsy so we have listed their outcome separately.|||percent change in eGFR from wk 0 to mo 3||Full Range|Mean
2626933|NCT01895101|Secondary|Number of Participants Requiring Surgical Re-exploration|the secondary objective of this study is to determine whether pericardial lavage with saline gives an improvement in haemostasis, compared with no pericardial lavage, resulting in a reduction of surgical re-explorations and post-operative 12-hour blood loss. The choice for a surgical re-exploration will be decided according to the ICU protocol.|participants will be followed for the duration of ICU stay, an expected average of 2 days||||participants|||Number
2626934|NCT01895101|Primary|Postoperative Blood Loss|The primary study parameter is 12 hours postoperative blood loss and is assessed by postoperative chest tube production. Postoperative chest tube production 12 hours after surgical procedure|12 hours postoperative||||ml||Inter-Quartile Range|Median
2626935|NCT01895088|Primary|Change (Increase) in Uncorrected Near Visual Acuity|The change in the number of lines of threshold visual acuity achieved postoperatively.|Baseline and 2 years||||lines of visual acuity improvement||Standard Deviation|Mean
2626936|NCT01895062|Secondary|The Frequency of Interventions to Alleviate RI in the cNEP Group Compared to the no cNEP Group.|interventions such as reduction of sedative medication or jaw thrust.|1 hour||||interventions to restore airway|||Number
2626937|NCT01895062|Secondary|The Incidence of Subjects With One or More RI in the cNEP Group Compared to the no cNEP Group.||1 hour|||||||
2626938|NCT01895062|Secondary|The Safety of cNEP as Determined by Adverse Events Reported by the Investigators.||1 hour|||||||
2626939|NCT01895062|Primary|RI Events in the cNEP Group Compared to the no cNEP Group, Where RI is Defined as Either: i Oxygen Saturation < 90% or ii. Apneas/Hypopneas of > 15 Sec Duration i. Oxygen Saturation <90% ii. Presence of Apneas or Hypopneas|Mean RI events in the no cNEP group was 3.5 compared to 1.92 in the cNEP group (p=0.022)|1 hour|Not all subjects were evaluable due to malfunction of the respiratory monitoring equipment in several.|||RI events||95% Confidence Interval|Mean
2626940|NCT01895036|Primary|Successful Discontinuation of Buprenorphine|Number of individuals successfully discontinuing buprenorphine during the inpatient phase and through follow-up.|7 weeks||||Participants|||Count of Participants
2626941|NCT01894984|Secondary|Number of Participants With Reasons for Discontinuation From Study Treatment|Number of participants with reasons for discontinuation from study treatment is reported here because participants provided multiple reasons for discontinuation.|Month 6|Analysis population included all enrolled participants.|||Participants|||Number
2626942|NCT01894984|Secondary|Percentage of Participants Attaining Remission Criteria|Remission is defined as a clinical status where for each core symptoms (that are, delusions, conceptual disorganization, hallucinatory behavior, mannerisms and posturing unusual thought content, blunted affect, passive or apathetic social withdrawal and lack of spontaneity and flow of conversation) were assessed at a low-mild symptom intensity level, where such absent, borderline, or mild symptoms do not influence an individual's behavior.|Month 6|ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.|||Percentage of Participants|||Number
2626943|NCT01894984|Secondary|Percentage of Participants With Relapse at Week 24|Percentage of participants with relapse was assessed wherein relapse was defined as hospitalization due to the aggravation of psychiatric symptoms of disease condition.|Week 24|ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.|||Percentage of Participants|||Number
2626944|NCT01894984|Secondary|Clinical Global Impressions-Severity (CGI-S) Score|"The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline and Week 24|ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.|||units on a scale||Standard Deviation|Mean
2626945|NCT01894984|Secondary|Total Personal and Social Performance (PSP) Score|The PSP is a clinician-rated scale that reflects social functioning in 4 domains of behavior (socially useful activities including work and study, personal and social relationships, self care, and disturbing and aggressive behaviors). The total score ranges from 1 to 100 (score of 71 to 100 will have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision) divided into 10 equal intervals to rate the degree of difficulty (i=absent to vi=very severe) in each of the 4 domains.|Baseline and Week 24|ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.|||units on a scale||Standard Deviation|Mean
2626946|NCT01894984|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 24|Intent to treat (ITT) population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations.|||units on a scale||Standard Deviation|Mean
2626947|NCT01894919|Secondary|Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs), Medically Attended AEs and AEs Leading to Withdrawal for Entire Study Period.|The number of subjects reporting unsolicited SAEs, medically attended AEs and AEs leading to withdrawal after receiving Bexsero® booster vaccination (24 to 36 months after completion of vaccination course according to different schedules in the parent study) or two catch-up schedule of Bexsero® vaccine is reported.|Throughout the entire study period|Analysis was done on unsolicited safety set: All subjects in the Exposed Set with unsolicited adverse event data.|||Subjects|||Number
2626948|NCT01894919|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination.|The number of subjects reporting unsolicited adverse events after receiving Bexsero® booster vaccination (24 to 36 months after completion of vaccination course according to different schedules in parent study) or two cach up schedule of Bexsero® vaccine is reported.|From day 1 through day 7 after any vaccination and throughout entire study period for all other AEs.|Analysis was done on unsolicited safety set: All subjects in the Exposed Set with unsolicited adverse event data.|||Subjects|||Number
2653307|NCT01644240|Primary|Vss|Apparent volume of distribution at steady state|Day 5||||L||Standard Deviation|Mean
2626949|NCT01894919|Secondary|Number of Newly Recruited naïve Subjects (Aged 8 to 12 Years of Age) Solicited Local and Systemic Adverse Events After Receiving Bexsero® Vaccine.|The number newly recruited naïve subjects (aged 8 to12 years of age) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study.|From day 1(6 hr) through day 7 after vaccination|Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data.|||Subjects|||Number
2626950|NCT01894919|Secondary|Number of Subjects (8 to 12 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine.|Number of subjects (8 to 12 years of age) reporting solicited local and systemic adverse events after receiving Bexsero® booster vaccine.|From day 1 (6 hr) through day 7 after vaccination|Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data.|||Subjects|||Number
2626951|NCT01894919|Secondary|Number of Newly Recruited Subjects (Aged 35 Months to 7 Years) Reporting Solicited Local and Systemic Adverse Events After Receiving Catch-up Doses of Bexsero® Vaccine.|The number of newly recruited subjects (aged 35 months to 7 years) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study.|The number of newly recruited subjects (aged 35 months to 7 years) reporting solicited local and systemic adverse events after receiving two catch-up doses of Bexsero® vaccine in the present study|Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data.|||Subjects|||Number
2626952|NCT01894919|Secondary|Number of Subjects (35 Months to 7 Years of Age) Reporting Solicited Local and Systemic Adverse Events After Receiving Bexsero® Booster Vaccine.|The number of subjects (35 months to 7 years of age) with solicited local and systemic adverse events after receivingBexsero® booster vaccine in the present study.|From day 1 (6 hr) through day 7 after vaccination|Analysis was done on solicited safety set: All subjects in the Exposed Set with solicited adverse event data|||Subjects|||Number
2626953|NCT01894919|Secondary|The GMRs of hSBA Titers After Two Catch up Doses of Bexsero® Vaccination Versus hSBA Titers at Baseline.|The within-subject GMRs of hSBA titers at one month after receiving the second catch up dose to hSBA titers at baseline, for naïve subjects who received two catch up doses of Bexsero® vaccination in this study are reported.|At Baseline (Day 1)|Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).|||Ratio||95% Confidence Interval|Geometric Mean
2626954|NCT01894919|Secondary|The GMTs in Subjects Who Received Two Catch up Doses of Bexsero® Vaccination.|The hSBA antibody titers in vaccine-naïve subjects , after receiving two catch up doses of Bexsero® vaccination in this study, are reported in terms of GMTs.|At Baseline and One month post second vaccination (Day 61)|Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).|||Titers||95% Confidence Interval|Geometric Mean
2626955|NCT01894919|Secondary|Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Two Catch up Doses of Bexsero® Vaccination.|The percentage of vaccine-naïve subjects with a four-fold rise in hSBA titers from baseline, one month after receiving two catch up doses of Bexsero® booster vaccination in comparison to prevaccination in this study are reported.|One month post second vaccination (Day 61)|Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).|||Percentage of subjects||95% Confidence Interval|Number
2626956|NCT01894919|Secondary|Percentage of Subjects With hSBA Titers ≥ 8 , After Receiving Two Catch up Doses of Bexsero® Vaccination.|The percentage of vaccine-naïve subjects with hSBA titers ≥8, one month after receiving two catch up doses of Bexsero® booster vaccination in this study are reported.|At Baseline and One month post second vaccination (Day 61)|Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).|||Percentage of subjects||95% Confidence Interval|Number
2626957|NCT01894919|Secondary|Percentage of Subjects With hSBA Titers ≥ 4 or ≥ 5, After Receiving Two Catch up Doses of Bexsero® Vaccination|The percentage of vaccine-naïve subjects with hSBA titers ≥ 4 against H44/76, 5/99 and NZ98/254 strains, and ≥ 5 against M10713 strain, one month after receiving two catch up doses of Bexsero® booster vaccination in this study.|At Baseline and One month post second vaccination (Day 61)|Analysis was done on FAS-catch-up population: All subjects in the Enrolled Set who receive at least one study vaccination and provide evaluable serum samples whose assay results are available on at least one post-baseline visit (visit 1 or visit 2).|||Percentage of subjects||95% Confidence Interval|Number
2626958|NCT01894919|Secondary|The Geometric Mean Ratio (GMR) of hSBA Titers, One Month After Receiving Bexsero® Booster Vaccination in the Present Study.|The within-subjects GMR of hSBA antibody titers (one month post booster vaccination versus pre vaccination) after Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the within-subject GMR for the 1st dose of rMenB+OMV NZ vaccination of age matched naïve subjects.|Day 1 and Day 31|Analysis was done on FAS-Booster:All subjects in the Enrolled Set who receive a study vaccination & provide an evaluable serum sample at visit 2 (1 month post booster dose) & received all scheduled vaccinations in V72_28 (excluding naïve groups). The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Ratio||95% Confidence Interval|Geometric Mean
2626959|NCT01894919|Secondary|The GMTs Against N.Meningitidis Serogroup B, One Month After Receiving Bexsero® Booster Vaccination in the Present Study.|The hSBA antibody titers in subjects after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the 1st dose of Bexsero® vaccine in age matched vaccine-naïve subjects in terms of GMTs.|At Visit 1 and one month post booster vaccination (Day 31)|Analysis was done on FAS-Booster:All subjects in the Enrolled Set who receive a study vaccination & provide an evaluable serum sample at visit 2(1 month post booster dose) & received all scheduled vaccinations in V72_28(excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Titers||95% Confidence Interval|Geometric Mean
2626960|NCT01894919|Secondary|Percentage of Subjects With Four-fold Rise in hSBA Titers, After Receiving Bexsero® Vaccination in This Study.|The percentage of subjects with a four-fold rise in hSBA titers after receiving Bexsero® booster vaccination in this study to pre vaccination (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.|One month after booster vaccination (day 31)/24-36 months (Visit 1)|Analysis was done on FAS-booster:All subjects in the Enrolled Set who receive a study vaccination & provide an evaluable serum sample at visit 2(1 month post booster dose) & received all scheduled vaccinations in V72_28 (excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Percentage of subjects||95% Confidence Interval|Number
2626961|NCT01894919|Secondary|Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis serogroupB, After Receiving Bexsero® Booster Vaccination in This Study.|The percentage of subjects with hSBA titers ≥ 8, after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study) alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.|At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)|Analysis was done on FAS-booster:All subjects in the Enrolled Set who receive a study vaccination & provide an evaluable serum sample at visit 2(1 month post booster dose) & received all scheduled vaccinations in V72_28 (excluding naïve groups).The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Percentage of subjects||95% Confidence Interval|Number
2626962|NCT01894919|Secondary|Percentage of Subjects With hSBA Titers ≥4 or ≥ 5 Against N.Meningitidis Serogroup B, After Receiving Bexsero® Booster Vaccination in This Study.|The percentage of subjects with hSBA titers ≥ 4 against H44/76, 5/99 and NZ98/254 strains, and with hSBA titers ≥ 5 against M10713 strain, after receiving Bexsero® booster vaccination in this study (24 to 36 months after completion of vaccination course according to different schedules in parent study), alongside the corresponding response after the first dose of Bexsero® vaccine in age matched vaccine-naïve subjects.|At 24-36 months (Visit 1) and one month after booster vaccination (Day 31)|Analysis was done on FAS - booster: All subjects in the Enrolled Set who receive a study vaccination and provide an evaluable serum sample at visit 2 (one month after the booster dose administration) and received all scheduled vaccinations in the parent study V72_28 (excluding naïve groups).|||Percentage of subjects||95% Confidence Interval|Number
2626963|NCT01894919|Primary|The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus Visit 1 in the Parent Study.|The within-subjects GMR of GMTs at 24 to 36 months versus visit 1 in the vaccination course according to different schedules vaccination in the parent study are reported.|At Day 1 in this study over visit 1 in the vaccination course in the parent study|Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1.This outcome measure applies to only groups 02_2_5 & 02_6_10 as the GMRs were calculated at 24-36 months after completion of vaccination course in the parent study over subjects belonging to groups 02_2_5 & 02_6_10.|||Ratio||95% Confidence Interval|Geometric Mean
2626964|NCT01894919|Primary|The Geometric Mean Ratio (GMR) of hSBA GMTs Against N. Meningitidis Serogroup B, 24 to 36 Months Versus 1 Month After Completion of Bexsero® Vaccination Course According to Different Schedules in the Parent Study.|The within-subjects GMR of GMTs at 24 to 36 months versus 1 month after completion of Bexsero® vaccination course according to different schedules vaccination in parent study are reported.|At Day 1 in this study over one month after the completion of the vaccination course in the parent study|Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1. The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Ratio||95% Confidence Interval|Geometric Mean
2626965|NCT01894919|Primary|The hSBA Geometric Mean Titers (GMTs) Against N.Meningitidis Serogroup B Strains|The hSBA antibody titers in subjects, 24 to 36 months after completion of Bexsero® vaccination course according to different schedules in the parent study, are presented in terms of vaccine-group-specific GMTs, alongside with the corresponding antibody responses in age-matched vaccine-naïve subjects at baseline.|24-36 months after booster dose in the parent study; baseline for vaccine-naïve subjects|Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1. The number of participants analyzed is the number of subjects assessed for this particular endpoint.|||Titers||97.5% Confidence Interval|Geometric Mean
2626966|NCT01894919|Primary|Percentage of Subjects With hSBA Titers ≥ 8 Against N.Meningitidis Serogroup B Strains|The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules is presented in terms of the percentage of subjects in each vaccine group with hSBA titers ≥ 8, alongside with the corresponding antibody responses in age matched vaccine naïve subjects at baseline.|At 24-36 months after booster dose in the parent study: baseline for vaccine-naïve subjects|Analysis was done on FAS-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1.|||Percentage of subjects||95% Confidence Interval|Number
2626967|NCT01894919|Primary|Percentage of Subjects With Human Serum Bactericidal Activity Titers (hSBA) ≥ 4 or ≥ 5 Against Neisseria Meningitidis (N. Meningitidis) Serogroup B Strains|"The antibody persistence in subjects, 24 to 36 months after completion of Bexsero® vaccination course in the parent study according to different schedules, is presented in terms of the percentage of subjects in each vaccine group, with hSBA titers ≥ 4 for what concerns the H44/76, 5/99 and NZ98/254 strains, and hSBA titers ≥ 5 for M10713 strain, alongside with the corresponding antibody responses in age-matched vaccine naïve subjects at baseline.~The functional bactericidal antibodies directed against serogroup B meningococcal were assessed by the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA)."|24 or 36 months after booster dose in the parent study; baseline for vaccine-naïve subjects|Analysis was done on Full Analysis Set (FAS)-persistence: All subjects in the Enrolled Set who provide an evaluable serum sample at Visit 1.|||Percentage of subjects||95% Confidence Interval|Number
2626968|NCT01894906|Secondary|Dialysate OutFlow Iron Concentration|Dialysate outflow iron concentration was calculated for each treatment group at t = 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours.|4 hours|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.|||micrograms/L||Standard Deviation|Mean
2626970|NCT01894906|Primary|Net Iron Delivery From SFP Via the Dialysate|To measure the SFP-derived total iron from the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate). Expended dialysate over the intervals of 0.5, 1, 2 ,3 and 4 hours will be collected and measured. Aliquots will be analyzed for iron content. The mean cumulative net iron delivery will be reported.|one dialysis session (approximately 4 hours)|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.|||microgram||Standard Deviation|Mean
2626971|NCT01894906|Secondary|Pharmacokinetics of Serum Iron and Exploratory Modeling|The serum Total Iron, Transferrin Bound Iron (TBI) and Non-transferrin Bound Iron (NTBI) pharmacokinetic parameters (baseline corrected and total) will be listed and summarized for each membrane group and overall. The mean serum total iron, TBI, NTBI, unsaturation iron binding capacity (UIBC) and total iron binding capacity (TIBC) concentrations at baseline (BL), end-of-treatment, and the change from BL will be listed for each group (Baxter and Gambro Polyflux), measured from the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate).|one dialysis session (approximately 4 hours)|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.|||microgram/dL||Standard Deviation|Mean
2626972|NCT01894906|Secondary|To Compare the Amount of SFP-derived Iron Administered Under Various Treatment Conditions to the Reference HD|To compare the amount of SFP-derived iron administered under various treatment conditions to the reference HD (Treatment B: SFP, new membrane, high Qb/Qd, 37 mEq bicarbonate): Dialyzer reuse, Low machine bicarbonate delivery, Polyarylethersulfone (PAES) membrane, and Low Qb/Qd.Iron concentration in timed dialysate collections will be analyzed. Expended dialysate over the intervals of 0.5, 1, 2 ,3 and 4 hours will be collected and measured. Aliquots will be analyzed for iron content. The mean cumulative net iron delivery will be reported.|one dialysis session (approximately 4 hours)|For this preliminary and explorative study, no prospective calculations of statistical power were made; statistics were descriptive only. All subjects were included in the calculation of all study outcomes.|||microgram||Standard Deviation|Mean
2626973|NCT01894841|Secondary|Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity|Intensity of ideation was measured using the Columbia Scale for Suicide Ideation intensity of ideation item. Item responses range from 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent), with higher scores indicating more severe ideation. Minimum score on the ideation measure is 1 and maximum score is 5.|baseline, 3, 6, 9, & 12 month post-hospitalization|The sample sizes used in this analysis are smaller than the full samples recruited per group because of dropout from baseline to 1 year followup.|||units on a scale||Standard Deviation|Mean
2626974|NCT01894841|Secondary|Treatment History Interview|We used an item measuring psychiatric hospitalizations from the Treatment History Interview to measure treatment utilization. Study participants indicated how many times they had been psychiatrically hospitalized since the prior study timepoint. We log transformed this variable at each timepoint to meet statistical assumptions of normality for our analyses.|3, 6, 9, & 12 month follow up|The number of participants in this analysis per group is smaller than was recruited at baseline due to dropout across time points.|||log(psychiatric hospitalizations)||Standard Deviation|Mean
2626975|NCT01894841|Secondary|World Health Organization Disability Assessment Schedule (WHODAS) II|The World Health Organization Disability Assessment Schedule (WHODAS II) is a validated, self-reported instrument assessing current impairment in functioning. Possible scores for each item range from 1 (None) to 5 (Extreme or cannot do). We calculated an Average Global Score for inclusion in analyses by dividing the total score by the number of items included in the measure (possible range of 1-5). Higher scores indicate greater impairment in functioning. We examined changes in overall functioning from baseline in these analyses.|Baseline, 3, 6, 9, & 12 month follow ups|The number of participants in this analysis per group is smaller than was recruited at baseline due to dropout across time points.|||score on a scale||Standard Deviation|Mean
2626976|NCT01894841|Secondary|Brief Symptom Inventory|The Brief Symptom Inventory is a validated, self-reported instrument assessing current psychiatric symptomatology. Possible scores for each item range from 0 (not at all) to 4 (extremely), and total scores are represented by a Global Severity Index (range 0 to 212).Higher scores indicate greater psychological distress.|Baseline, 3, 6, 9, & 12 month follow up|There are fewer subjects in this analysis than were recruited for both groups at baseline due to dropout across timepoints.|||score on a scale||Standard Deviation|Mean
2626977|NCT01894841|Secondary|Changes in Beck Hopelessness Scale|The Beck Hopelessness Scale was used to measure changes in hopelessness from baseline to 12-month followup. Items are dichotomous (0: False and 1: True), with a total score ranging from 0-20. Higher scores indicate greater hopelessness.|Baseline, 3, 6, 9, & 12 month follow up|2 participants from the CLASP condition were withdrawn from the study after enrollment and randomization prior to completing the baseline assessment. Number of participants analyzed is smaller per group due to dropout from baseline to 12 month follow-up and missing data for some time points.|||score on a scale||Standard Deviation|Mean
2626978|NCT01894841|Primary|Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior|Items measuring attempt behavior (number of Actual Attempts, number of Aborted Attempts, number of Interrupted Attempts) From the Columbia Suicide Severity Rating Scale were summed to create a composite variable indexing attempt behavior. Higher scores indicate more attempt behavior. We log transformed this variable at all time points to meet assumptions of normality.|baseline, 3, 6, 9, & 12 month post-hospitalization|The sample sizes used in this analysis are smaller than the full samples recruited per group because of dropout from baseline to 1 year followup.|||log(attempts)||Standard Deviation|Mean
2626979|NCT01894776|Secondary|Safety/Tolerability of the Treatments|description and frequency of adverse events for all participants during the study.|30 days||||Participants|||Count of Participants
2626980|NCT01894776|Primary|Maraviroc and Rifabutin C12/C24/Cmax PK Concentrations in Plasma.|Maraviroc + Rifabutin pharmacokinetics: Maraviroc only Cmax (μg/L), Maraviroc only C12 (μg/L), Maraviroc + Rifabutin Cmax (μg/L), Maraviroc + Rifabutin C12 (μg/L), Rifabutin Cmax (μg/L), Rifabutin C24 (μg/L), 25-O-desacetyl rifabutin Cmax (μg/L), 25-O-desacetyl rifabutin C24 (μg/L).|Maraviroc: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hour. Rifabutin: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hour..||||μg/L||90% Confidence Interval|Geometric Mean
2657066|NCT01609296|Secondary|TLR|Any Target lesion revascularisation|12 months||||Participants|||Count of Participants
2626981|NCT01894776|Primary|Pharmacokinetics of Maraviroc and Rifabutin AUC 0-12/24|Maraviroc pharmacokinetics: Maraviroc only AUC (h*μg/L), Maraviroc + Rifabutin AUC (h*μg/L), Rifabutin AUC (h*μg/L), 25-O-desacetyl rifabutin AUC (h*μg/L).|Maraviroc: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10 and 12 hour. Rifabutin: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 24 hour..||||h*μg/L||90% Confidence Interval|Geometric Mean
2626982|NCT01894672|Other Pre-specified|Pharmacokinetic (PK) Analysis: Geometric Mean of Maximum Observed Concentration (Cmax) of LGX818 at Steady State|PK parameters will be determined on PK profiles after the first dose and at steady-state using non-compartmental method(s) using WinNonlin|Cycle 1 - Day 1, 15; Cycle 2 - Day 15; Cycle 3 - Day 1, Day 15|Data were not collected||||||
2626983|NCT01894672|Other Pre-specified|Overall Survival|Overall survival will be calculated for the start of treatment to the date of last death or follow-up.|1.5 years||2020-04-30|04/2020||||
2626984|NCT01894672|Secondary|Response Rate|Response rate (defined as complete + partial response) and 95% confidence interval will be estimated.|1.5 years||||percentage of participants||95% Confidence Interval|Number
2626985|NCT01894672|Primary|Number of Participants With Response According to RECIST v1.1 Criteria|Efficacy for all patients will be evaluated by the study sites using RECIST v1.1 and response criteria based on contrast-enhanced CT. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Progression must also involve an increase in size of measurable lesions by at least 5 mm, to minimize the possibility that small changes in a small number of target lesions is falsely interpreted as progression.Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|1.5 years||||Participants|||Count of Participants
2626986|NCT01894620|Secondary|Improvement in Sleep Quality|We anticipate to see an improvement on the sleep quality of the patients (assessed by EEG waves during sleep) after 4 weeks of rTMS treatment.|After four weeks after the start of treatment|Note that this aspect of the study was not performed. Therefore, no data is available.||||||
2626987|NCT01894620|Primary|Cognitive Improvement Measured Using Montreal Cognitive Assessment (MoCA)|We anticipate to see a cognitive improvement as measured by the Montreal Cognitive Assessment (MoCA) after two weeks of applying rTMS. This assessment tool gives a score from 0 to 30 points, with higher scores representing better cognitive ability.|Change between baseline and 2 weeks after the start of treatment|Results are divided into the two treatment type groups (real vs. sham).|||MOCA score change at 2 weeks||Standard Error|Mean
2626988|NCT01894607|Secondary|Assess Image Quality of the Contrast Enhanced Ultrasound (CEUS)|Number of participants that show better image quality in terms of lesion conspicuity and enhancement following contrast injection vs. baseline.|1 day|1 participant was ineligible.|||participants|||Number
2626989|NCT01894607|Primary|Successful Capture of IO-CEUS Images|Primary objective is to determine feasibility of obtaining intraoperative (IO) contrast enhanced ultrasound (CEUS) images in participants undergoing open partial nephrectomy. Feasibility defined as the successful capture of IO-CEUS images in 8 out of 10 participants.|1 day|1 participant was ineligible.|||participants|||Number
2626990|NCT01894581|Primary|Change in the Average LH Pulse Amplitude|To test the pituitary and hypothalamic output, we examined LH secretion (unstimulated and in response to gonadotropin-releasing hormone (GnRH) stimulation) during 8-hour blood sampling studies at 10 min intervals. The primary outcome measure is the change in the average LH pulse amplitude for each patient from baseline to after supplementation.|10 minute intervals during 8 hour blood sampling studies. Subjects will undergo two menstrual cycles of study, one prior to dietary supplementation and one after supplementation.||||IU/L||Standard Deviation|Mean
2626991|NCT01894568|Secondary|Percentage of Participants With Total and Nocturnal Hypoglycemic Events (HE)|Percentage of participants with hypoglycemic events (total or nocturnal) to Week 26 based on BG Threshold 70mg/dL.|Baseline to Week 26|All participants who were randomized and received at least 1 dose of study drug and had evaluable HE data.|||percentage of participants|||Number
2626992|NCT01894568|Secondary|Percent Hemoglobin A1c at Week 26|HbA1c is a test that measures a participant's average blood glucose level over the past 2 to 3 months. LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|Week 26|All participants who were randomized and received at least 1 dose of study drug and had evaluable HbA1c data.|||percent of HbA1c||Standard Error|Least Squares Mean
2626993|NCT01894568|Secondary|Change From Baseline to 12 Weeks in Hemoglobin A1c (HbA1c)|Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months.LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All participants who were randomized and received at least 1 dose of study drug and had evaluable HbA1c data.|||percent of HbA1c||Standard Error|Least Squares Mean
2626994|NCT01894568|Secondary|Intra-Participant Variability of the Fasting Blood Glucose (FBG)|Intra-participant variability of Fasting Blood Glucose (FBG), which was measured by Self Monitored Blood Glucose (SMBG), was assessed by the standard deviation of the FBG measurement at the Week 26 visit. LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|Week 26|All participants who were randomized and had at least 1 dose of study drug and had evaluable FBG data.|||mg/dL||Standard Error|Least Squares Mean
2627006|NCT01894568|Secondary|Fasting Serum Glucose (FSG)|LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and sulfonylurea [SU]/meglitinide use), visit, and treatment-by-visit interaction.|Weeks 0 and 26|All participants who were randomized and received at least 1 dose of study drug and had evaluable FSG data.|||mg/dL||Standard Error|Least Squares Mean
2627386|NCT01890694|Secondary|Survival|Improved chances of survival when receiving Tolvaptan vs. standard of care|Post-discharge (6 months)|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
2626995|NCT01894568|Secondary|Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores|LBSS is a validated, participant-reported 33-item questionnaire with items rated on a 5-point Likert scale, where 0 = never and 5 - always. The LBSS measures behaviors to avoid hypoglycemia and its negative consequences (15 items) and worries about hypoglycemia and its negative consequences (18 items). Total score is the sum of all items (range 0 to 132). Higher total scores reflect greater fear of hypoglycemia. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) with country, treatment and metformin use as fixed effects and baseline score as a covariate. LBSS was assessed during screening visit (baseline) and again at Week 26.|Baseline, Week 26|All participants who were randomized and received at least 1 dose of study drug and had evaluable LBSS data.|||units on a scale||Standard Error|Least Squares Mean
2626996|NCT01894568|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ) Score|The Insulin Treatment Satisfaction Questionnaire is a validated instrument containing 22 items that assessed treatment satisfaction for participants with diabetes on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed score on a scale of 0-100, where a higher score indicate better treatment satisfaction. LS means was achieved using a MMRM model for post-baseline measures with stratification factors (country, HbA1c, and SU/meglitinide use) treatment, visit, treatment-by-visit as fixed effects. ITSQ was assessed at Week 4 (baseline) and Week 26.|Week 4 and 26|All participants who were randomized and received at least 1 dose of study drug and have evaluable ITSQ data. Missing endpoints were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2626997|NCT01894568|Secondary|Change From Baseline of European Quality of Life-5 Dimensions - 3 Levels (EuroQoL-5D-3L ) Index Score and Visual Analog Scale (VAS) Health State Score at Week 26|The EuroQoL-5D-3L questionnaire is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 3-level scale of 1 to 3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores ranged from -0.11 to 1.0 where a score of 1.0 indicates perfect health. Overall health state score was self-reported using a VAS marked on a scale of 0 to 100 (0 indicates worst imaginable health state and 100 indicates best imaginable health state. LS means were calculated using analysis of covariance (ANCOVA) for actual measures and changes from baseline at endpoint using LOCF method: adjusting for treatment, stratification factors (region, HbA1c and SU/meglitin.|Baseline, Week 26|All participants who were randomized and received at least 1 dose of study drug and had evaluable EQ-5D data. Missing endpoints were imputed with last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2626998|NCT01894568|Secondary|Percentage of Participants With Detectable Anti-Insulin Peglispro Antibodies at Week 26|For participants with detectable anti-insulin peglispro antibody level, the percentage of participants with positive cross-react with endogenous insulin was summarized.|Week 26|All participants who were randomized and received at least 1 dose of study drug and had evaluable antibody data.|||percentage of participants|||Number
2626999|NCT01894568|Secondary|Concentration of Triglycerides, Total Cholesterol, Low-Density Lipoprotein (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C) at Week 26|LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit, and treatment-by-visit interaction.|Week 26|All participants who were randomized and received at least 1 dose of study drug and had evaluable laboratory data.|||mg/dL||Standard Error|Least Squares Mean
2627000|NCT01894568|Secondary|Percentage of Participants Achieving Steady-State of Basal Insulin Dose at 26 Weeks (Time to Steady State for Basal Insulin [Stable Maximum Dose])||Week 26|All participants who were randomized and received at least 1 dose of study drug and had evaluable insulin dose data.|||percentage of participants|||Number
2627001|NCT01894568|Secondary|Insulin Dose Per Kilogram (kg) of Body Weight|LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide), visit, and treatment-by-visit interaction.|Week 26|All participants who were randomized and received at least 1 dose of study drug and had evaluable insulin dose and body weight data.|||units per kg||Standard Error|Least Squares Mean
2627002|NCT01894568|Secondary|Percentage of Participants With HbA1c ≤6.5%|Percentage of participants with HbA1c ≤6.5% at Week 26 were made using a logistic regression model for endpoint used last observation carried forward (LOCF) method including treatment, baseline HbA1c value.|Week 26|All participants who were randomized and received at least 1 dose of study drug and had evaluable HbA1c data.|||Percentage of participants|||Number
2627003|NCT01894568|Secondary|9-Point Self-Monitored Blood Glucose (SMBG)|LS means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction. The 9-point SMBG are measured at: Pre-morning meal, 2 hours(hr) post morning meal, pre-midday meal, 2 hr post midday meal, pre-evening meal, 2 hr post pre-evening meal, bedtime, 0300 hr, and pre-morning meal next day, and should be performed on 2 non-consecutive days.|Week 0 and Week 26|All participants who were randomized and received at least 1 dose of study drug and had evaluable SMBG data.|||mg/dL||Standard Error|Least Squares Mean
2627004|NCT01894568|Secondary|Change From Baseline to Week 26 in Body Weight|LS Means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction.|Baseline, Week 26|All participants who were randomized and received at least 1 dose of study drug and had evaluable body weight data.|||Kilogram (kg)||Standard Error|Least Squares Mean
2627005|NCT01894568|Secondary|Fasting Blood Glucose (FBG)|LS Means were calculated using MMRM analysis adjusting for baseline, treatment, stratification factor (region, HbA1c, LDL-C, and SU/meglitinide use), visit and treatment-by-visit interaction.|Weeks 0 and 26|All participants who were randomized and received at least 1 dose of study drug and had evaluable FBG data.|||mg/dL||Standard Error|Least Squares Mean
2627051|NCT01894230|Secondary|Low Density Lipoprotein Cholesterol (LDLc) at Baseline, Month 3 and Month 8|The continuous outcomes LDLc will be modeled as a linear regression with arm and baseline LDL as predictors.|Baseline, Month 3, Month 8|All subjects with available data were included in the analysis.|||mg/dL||Standard Deviation|Mean
2627007|NCT01894568|Secondary|30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events|Hypoglycemia Events (HE) occurs when blood glucose level ≤ 70 milligram per deciliter (mg/dL) (<3.9 micromoles per liter [mmol/L]). Nocturnal HE includes any total HE that occurred between bedtime and waking. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models with treatment, baseline sulfonylurea/meglitinide use, baseline total hypoglycemia event rate, log (exposure/30 days) as the offset in the model. Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.|Baseline to Week 26|All participants who were randomized and received at least 1 dose of study drug and had evaluable HE data.|||Number of events per participant per 30d||Standard Error|Mean
2627008|NCT01894568|Primary|Change From Baseline to Week 26 in Hemoglobin A1c (HbA1c)|Hemoglobin A1c (HbA1c) is a test that measures a participant's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis adjusting for treatment, stratification factors (region, sulfonylureas/meglitinide use, baseline Low-Density Lipoprotein [LDL-C], visit, treatment-by-visit interaction, and baseline HbA1c as fixed effects and participants as the random effect. P-value is from MMRM with terms for treatment, visit, treatment-by-visit interaction, stratification, and baseline HbA1C.|Baseline, Week 26|All participants who were randomized and received at least 1 dose of study drug and had evaluable HbA1c data|||percent of HbA1c||Standard Error|Least Squares Mean
2627009|NCT01894555|Primary|Changes in Platelet Transcriptome|"Comparison of platelet transcriptome before aspirin therapy with platelet transcriptome after aspirin therapy.~The expression levels of genes before aspirin therapy was compared with the expression level of the genes after aspirin therapy. The expression levels were measured using the FPKM unit (Fragments Per Kilobase of transcript per Million mapped reads). The gene with the highest difference (pre vs. post) in FPKM is being reported with name in the units area and the actual difference in the number area"|4 weeks|The data were analyzed combining results from two studies (33 from this study and additional 24 individuals from study NCT02234427; total population size = 57) to improve the power to detect a difference. Same results are reported for the two studies. Note that the top most gene (HBG1) with the lowest p-value is being reported.|||FPKM difference for HBG1 Gene||Standard Error|Mean
2627010|NCT01894503|Secondary|Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ|Concentration of mometasone furoate was determined in blood samples collected at baseline, Days 3, 7, 14, 21 and 30 using a validated method with the lowest level of quantification (LLOQ) of 30 pg/ml.|Days 3, 7, 14, 21 and 30|Per-treatment evaluable population consisting of all patients|||participants|||Number
2627011|NCT01894503|Primary|Number of Sinuses With Successful Implant Delivery|Defined as successful access and deployment of the S8 Sinus Implant to the target ethmoid sinus at the end of the baseline procedure|End of baseline procedure|Per-treatment evaluable population, consisting of all sinuses in which placement of the S8 Sinus Implant was attempted.|||Sinuses|Sinuses||Count of Units
2627012|NCT01894477|Secondary|Relapse Risk as Measured by Degree of Change in Gene Expression Profiles|Among genes identified whose expression is modified by conditioning, degree of change in expression will be evaluated to determine if it is correlated with relapse risk and offers improved prediction of relapse risk over that obtained with standard clinical parameters (cytogenetics, blast count, International Prognostic Scoring System score, minimal residual disease. To account for censoring and the competing risk of non-relapse mortality (NRM), the analysis will be a time-to-event analysis of relapse using Cox regression, with change in expression as a continuous covariate (on a log scale). 8|Baseline and at day 0 within 6 hours of conditioning prior to transplant|||||||
2627013|NCT01894477|Secondary|Change in Gene Expression Profiles|Differences between arms in the changes in gene expression will be compared. 80% power to detect mean differences of approximately 1.4 standard deviation units, at the 2-sided 0.05 level of significance (with Bonferroni correction for 50 genes).|Baseline and at day 0 within 6 hours of conditioning prior to transplant|||||||
2627014|NCT01894477|Secondary|Overall Survival (OS)||Up to 2 year|||||||
2627015|NCT01894477|Secondary|NRM||Up to 5 years|||||||
2627016|NCT01894477|Secondary|Incidence of Relapse/Progression||Up to 5 year|||||||
2627017|NCT01894477|Secondary|Incidence of Chronic GVHD Graded by the NCI CTCAE Version 4.0||Up to 5 year||2023-01-31|01/2023||||
2627018|NCT01894477|Secondary|Number of Participants With Acute GVHD, Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0||Up to 84 days||||Participants|||Count of Participants
2627019|NCT01894477|Primary|Number of Participants That Did Not Progress Within 6 Months|Progression is defined as relapse|At 6 months post-transplant||||Participants|||Count of Participants
2627020|NCT01894256|Other Pre-specified|CL/F of Unbound Olaparib|Calculated from dose divided by free AUC|Part A: Day 1, 1 hour post-dose|"Subset of PK analysis set with protein binding blood sample available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||L/hour||Standard Deviation|Median
2627021|NCT01894256|Other Pre-specified|Free AUC of Olaparib|AUC of unbound olaparib; calculated by multiplying total AUC by estimated protein binding|Part A: Day 1, 1 hour post-dose|"Subset of PK analysis set with protein binding blood sample available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2627022|NCT01894256|Other Pre-specified|Free Cmax of Olaparib|Cmax of unbound olaparib; calculated by multiplying total Cmax value by estimated protein binding|Part A: Day 1, 1 hour post-dose|"Subset of PK analysis set with protein binding blood sample available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2627023|NCT01894256|Other Pre-specified|Protein Binding of Olaparib|Degree to which olaparib binds to the proteins within blood plasma|Part A: Day 1, 1 hour post-dose|"Subset of PK analysis set with protein binding blood sample available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||% plasma||Standard Deviation|Mean
2627024|NCT01894256|Primary|t1/2 of Olaparib|Terminal half-life of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||Hours||Standard Deviation|Mean
2627025|NCT01894256|Primary|CLR of Olaparib|Renal clearance of olaparib, calculated as the ratio of amount of drug excreted over 24 hours to AUC0-24|Part A: Day 1, 0-12 hours and 12-24 hours post-dose|"Subset of PK analysis set with urine samples available. PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||L/hour||Standard Deviation|Mean
2627026|NCT01894256|Primary|CL/F of Olaparib|Apparent plasma clearance of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||L/hour||Standard Deviation|Mean
2627027|NCT01894256|Primary|Vz/F of Olaparib|Apparent volume of distribution of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||L||Standard Deviation|Mean
2627028|NCT01894256|Primary|Tmax of Olaparib|Time to reach maximum plasma concentration of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||Hours||Full Range|Median
2627029|NCT01894256|Primary|AUC0-t of Olaparib|Area under plasma concentration-time curve from zero to the last measurable time point of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2627030|NCT01894256|Primary|AUC of Olaparib|Area under plasma concentration-time curve from zero to infinity of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2627031|NCT01894256|Primary|Cmax of Olaparib|Maximum plasma drug concentration of olaparib|Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose|"PK analysis set: All patients who receive an olaparib dose and have full PK sampling up to 96 hours post-dose.~Any patients with major protocol deviations that affected the evaluability of the PK profile were excluded."|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2627032|NCT01894243|Primary|Apparent Volume of Distribution (Vz/F)||Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.|PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.|||L||Geometric Coefficient of Variation|Geometric Mean
2627033|NCT01894243|Primary|Terminal Half-life (t½)||Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.|PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.|||h||Geometric Coefficient of Variation|Geometric Mean
2627034|NCT01894243|Primary|Time to Reach Maximum Plasma Concentration (Tmax)||Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.|PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.|||h||Full Range|Median
2627035|NCT01894243|Primary|Ratio of Apparent Clearance Following Oral Administration (CL/F)|Summary of Ratio of Geometric Least Squares (GLS) Means|Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.|PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.|||ratio||90% Confidence Interval|Geometric Least Squares Mean
2627036|NCT01894243|Primary|Apparent Clearance Following Oral Administration (CL/F)|Summary of Geometric Least Squares (GLS) Means|Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.|PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.|||L/hr||90% Confidence Interval|Geometric Least Squares Mean
2627037|NCT01894243|Primary|Ratio of Area Under the Plasma Concentration Time Curve From Zero to the Last Measureable Time Point(AUC 0-t)|Summary of Ratio of Geometric Least Squares (GLS) Means|Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.|PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.|||ratio||90% Confidence Interval|Geometric Least Squares Mean
2627038|NCT01894243|Primary|Area Under the Plasma Concentration Time Curve From Zero to the Last Measureable Time Point(AUC 0-t)|Summary of Geometric Least Squares (GLS) Mean for ratio of mild hepatic impairment compared to normal|Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.|PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.|||μg*h/mL||90% Confidence Interval|Geometric Least Squares Mean
2627039|NCT01894243|Primary|Ratio of Area Under the Plasma Concentration Time Curve From Zero to Infinity (AUC) - Mild vs Normal and Moderate vs Normal|Summary of Ratio of Geometric Least Squares (GLS) Means|Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.|PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.|||ratio||90% Confidence Interval|Geometric Least Squares Mean
2637573|NCT01780922|Primary|Oxidative Damage to DNA Assessed by Plasma 8-hydroxy-2'-Deoxyguanosine (8-OHdG)||0, 2, 4, 8, 24 h||||ng/mL||Standard Error|Mean
2627040|NCT01894243|Primary|Area Under the Plasma Concentration Time Curve From Zero to Infinity (AUC)|Summary of Geometric Least Squares (GLS) Mean|Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.|PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.|||μg*h/mL||90% Confidence Interval|Geometric Least Squares Mean
2627041|NCT01894243|Primary|Ratio of Maximum Plasma Concentration (Cmax) - Mild vs Normal and Moderate vs Normal|Summary of ratio of Geometric Least Squares (GLS) Means|Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.|PK Analysis Set (Part A) One patient excluded from mild impairment group due to surgery that may affect olaparib absorption.|||ratio||90% Confidence Interval|Geometric Least Squares Mean
2627042|NCT01894243|Primary|Maximum Plasma Concentration (Cmax)|Summary of Geometric Least Squares (GLS) Mean for normal, mild and moderate hepatic impairment|Blood samples are collected at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post olaparib dose in Part A.|PK Analysis Set (Part A) One patient excluded from mild impairment arm due to surgery that may affect olaparib absorption.|||μg/mL||90% Confidence Interval|Geometric Least Squares Mean
2627043|NCT01894230|Secondary|Beliefs About Medications (BMQ) Score at Baseline, Month 3 and Month 8|"Questionnaire administered at baseline, 3 months, and 8 months~This instrument assesses beliefs regarding necessity and concerns related to disease-specific medications~The score ranges from 5 to 25 representing the sum of 5 questions. This will be modeled with linear regression including treatment as predictor. Baseline BMQ scores will also be included as a covariate to account for baseline variability.~Higher score corresponds to higher thought necessity and higher thought concerns about taking the medication. The higher the necessity score, the more the patient believed statins necessary for their health. The higher the concerns score, the more the patient was concerned about taking stains (side effects)."|Baseline, Month 3, Month 8|Only subjects that completed the Beliefs About Medications questionnaire were included in the analysis.|||units on a scale||Standard Deviation|Mean
2627044|NCT01894230|Secondary|Physical Activity Scale Score|"Activity levels will be compared at the end of 8-months. Activity levels are defined by a five-level ordinal variable (0-4; higher level corresponding to higher activity). which was calculated based on survey answers. An ordinal logistic regression model will be used with arm as predictor. The assumption of proportional odds will be checked, and if it is not met, a multinomial regression model will be used. -Baseline physical activity will also be included as a covariate to account for baseline variability.~Scale score (0-4): 0 - Inactivity, 1 - Ligh-intensity activity, 2 - moderate-intensity activity, 3 - Hard-intensity activity, 5 - very hard-intensity activity"|Baseline and Month 8|Only subjects that completed the Physical Activity survey were included in the analysis|||units on a scale||Standard Deviation|Mean
2627045|NCT01894230|Secondary|Change in Short Form -12 Item (SF-12) Health Survey - Mental Component (MC)|"Month 3 and Month 8 SF12 scores for mental and physical health will be compared. Both of these measures will be modeled as a linear regression with arm as predictor. Baseline SF-12 scores will also be included as a covariate to account for baseline variability.~Ranges from 0 to 100, where a zero score indicates the lowest level of mental health measured by the scales and 100 indicates the highest level of mental health."|Baseline, Month 3, Month 8|Only subjects that completed the SF-12 Health Survey were included in the analysis.|||units on a scale 0 to 100||Standard Deviation|Mean
2627046|NCT01894230|Secondary|Change in Short Form -12 Item (SF-12) Health Survey - Physical Component (PC)|"Month 3 and Month 8 SF12 scores for mental and physical health will be compared. Both of these measures will be modeled as a linear regression with arm as predictor. Baseline SF-12 scores will also be included as a covariate to account for baseline variability.~Ranges from 0 to 100, where a zero score indicates the lowest level of physical health measured by the scales and 100 indicates the highest level of physical health"|Baseline, Month 3, Month 8|Only subjects that completed the SF-12 Health Survey were included in the analysis.|||units on a scale||Standard Deviation|Mean
2627047|NCT01894230|Secondary|Brief Pain Inventory (BPI) Score - Pain Interference at Month 3 and Month 8|"Brief Pain Inventory data will be taken from 3 and 8-month follow up Patient Surveys. -Pain severity and pain interference will be compared between groups -Both of these measures will be modeled as a linear regression with arm as predictor. Baseline pain scores will also be included as a covariate to account for baseline variability.~Scores range from 0-10. Higher scores indicate higher pain interference with daily activities."|Month 3 and Month 8|Only subjects that completed the Brief Pain Inventory surveys were included in the analysis.|||units on a scale||Standard Deviation|Mean
2627048|NCT01894230|Secondary|Brief Pain Inventory (BPI) Score - Pain Severity at Month 3 and Month 8|"Brief Pain Inventory data will be taken from 3 and 8-month follow up Patient Surveys. Pain severity and pain interference will be compared between groups. Both of these measures will be modeled as a linear regression with arm, genotype, and site as predictors. Transformations of the response may be explored depending on the distribution of the regression residuals. Baseline pain scores will also be included as a covariate to account for baseline variability.~Scores range from 0-10. Higher scores indicate higher pain severity."|Month 3 and Month 8|Only subjects that completed the Brief Pain Inventory surveys were included in the analysis.|||units on a scale||Standard Deviation|Mean
2627049|NCT01894230|Secondary|Number of Participants Reporting New Statin Prescriptions|The number of new prescriptions is binary and will be modeled with logistic regression with arm, genotype, and site as predictors. Any variables imbalanced between arms will also be included as covariates.|Baseline, Month 3, Month 8|Only subjects reporting new prescriptions were included in the analysis.|||Participants|||Count of Participants
2627050|NCT01894230|Secondary|Medication Possession Ratio (MPR) From Baseline to Last Patient Follow-up|Medication possession ratio will be calculated based on number of statin medication refills over time from randomization to end of follow up. MPR is calculated as follows: 1.Sum of the days' supply of all statin medications is the sum of the number of pills dispensed for each statin prescription during follow up (taken from 3-month, 4-month and 8-month statin utilization review) 2.Sum of the days of follow up = date of 8-month follow up survey - date of randomization 3.MPR = #1/#2 MPR will be modeled as a linear regression with arm, genotype, and site as predictors.|Baseline to Last patient follow-up in study (3 months or 8 months)|Only subjects who re-initiated statin medication and reported statin medication refills were included in the analysis.|||ratio||Standard Deviation|Mean
2630018|NCT01856790|Secondary|the Incremental Meal-related Glucose Area Under Curve (AUC)||5-hour post prandial period after breakfast, lunch, and dinner||||mg*hr/dL||Standard Deviation|Mean
2627052|NCT01894230|Primary|Morisky Medication Adherence Scale (MMAS) Score|The Morisky Medication Adherence Scale (MMAS) is a self-reported measure of adherence, collected at baseline for general medication and at 3 and 8 months of followup for statin specific adherence. The eight-item MMAS survey will be used. This is a modified version of the original four-item MMAS capturing further aspects of adherence behavior. The survey includes 8 yes/no items that are summed to create an overall adherence score ranging from of 0 to 8, with higher scores indicating better adherence. The primary hypothesis is that the genetically guided statin therapy leads to greater adherence of statin therapy, corresponding to a higher MMAS score.|3 months and 8 months|Only participants who re-initiated statin use were eligible to do statin specific MMAS and included in the analysis.|||units on a scale||Standard Deviation|Mean
2627053|NCT01894178|Other Pre-specified|Number of Failed Attempts of Placing Endotracheal Tube Into Trachea|The intent is to report the number of attempts required to successfully advance the endotracheal tube into the trachea.|following intubation attempt|||||||
2627054|NCT01894178|Secondary|Percentage of Endotracheal Intubations Successful on First Attempt Attempts||following successful intubation or more than 5 attempts||||percentage of successful first attempts|||Number
2627055|NCT01894178|Primary|Length of Time Required for Successful Advancement of Endotracheal Tube Into Trachea||following successful intubation or lasting longer than 120 seconds||||seconds||Inter-Quartile Range|Median
2627056|NCT01894152|Other Pre-specified|Number of Participants With Extremely Late Stent Thrombosis (Definite or Highly Probable)|"This study as no primary or secondary endpoints, all endpoints are of equal weight.~Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"|> 365 days|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627057|NCT01894152|Other Pre-specified|Number of Participants With Late Stent Thrombosis (Definite or Highly Probable)|"This study as no primary or secondary endpoints, all endpoints are of equal weight.~Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"|>30 days - 365 days|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627058|NCT01894152|Other Pre-specified|Number of Participants With Sub-acute Stent Thrombosis (Definite or Highly Probable)|"This study as no primary or secondary endpoints, all endpoints are of equal weight.~Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"|> 1 day - 30 days|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627059|NCT01894152|Other Pre-specified|Number of Participants With Acute Stent Thrombosis (Definite or Highly Probable)|"This study as no primary or secondary endpoints, all endpoints are of equal weight.~Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: >1 year post stent implantation"|0 to 1 day|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627060|NCT01894152|Other Pre-specified|Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])|"This study as no primary or secondary endpoints, all endpoints are of equal weight.~All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention"|5 years||2019-12-31|12/2019||||
2627061|NCT01894152|Other Pre-specified|Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])|"This study as no primary or secondary endpoints, all endpoints are of equal weight.~All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention"|4 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627387|NCT01890694|Secondary|Hospital Readmission Rate|Lower readmission rate|Post-Discharge (6 months)|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
2627062|NCT01894152|Other Pre-specified|Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])|"This study as no primary or secondary endpoints, all endpoints are of equal weight.~All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention"|3 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627063|NCT01894152|Other Pre-specified|Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])|"This study as no primary or secondary endpoints, all endpoints are of equal weight.~All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention"|0 to 790 days|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627064|NCT01894152|Other Pre-specified|Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])|"This study as no primary or secondary endpoints, all endpoints are of equal weight.~All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention"|≤ 7 days after index procedure (Hospitalization)|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627065|NCT01894152|Other Pre-specified|Number of Participants With All Target Vessel Revascularization TVR|"This study as no primary or secondary endpoints, all endpoints are of equal weight.~Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself."|5 years||2019-12-31|12/2019||||
2627066|NCT01894152|Other Pre-specified|Number of Participants With All Target Vessel Revascularization TVR|"This study as no primary or secondary endpoints, all endpoints are of equal weight.~Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself."|4 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627067|NCT01894152|Other Pre-specified|Number of Participants With All Target Vessel Revascularization TVR|"Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|3 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627068|NCT01894152|Other Pre-specified|Number of Participants With All Target Vessel Revascularization TVR|"Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|0 to 790 days|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627069|NCT01894152|Other Pre-specified|Number of Participants With All Target Vessel Revascularization TVR|"Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|≤ 7 days after index procedure (Hospitalization)|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627070|NCT01894152|Other Pre-specified|Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)|"Myocardial Infarction (MI)~Q wave MI Development of new, pathological Q wave on the ECG~Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves This study as no primary or secondary endpoints, all endpoints are of equal weight."|5 years||2019-12-31|12/2019||||
2627071|NCT01894152|Other Pre-specified|Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)|"Myocardial Infarction (MI)~Q wave MI Development of new, pathological Q wave on the ECG~Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves This study as no primary or secondary endpoints, all endpoints are of equal weight."|4 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627072|NCT01894152|Other Pre-specified|Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)|"Myocardial Infarction (MI)~Q wave MI Development of new, pathological Q wave on the ECG~Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves This study as no primary or secondary endpoints, all endpoints are of equal weight."|3 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627073|NCT01894152|Other Pre-specified|Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)|"Myocardial Infarction (MI)~Q wave MI Development of new, pathological Q wave on the ECG~Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves This study as no primary or secondary endpoints, all endpoints are of equal weight."|0 to 790 days|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627074|NCT01894152|Other Pre-specified|Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)|"Myocardial Infarction (MI)~Q wave MI Development of new, pathological Q wave on the ECG~Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves This study as no primary or secondary endpoints, all endpoints are of equal weight."|≤ 7 days after index procedure (Hospitalization)|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627075|NCT01894152|Other Pre-specified|Number of All Death (Cardiac, Vascular, and Non-cardiovascular)|"Cardiac death:is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) This study as no primary or secondary endpoints, all endpoints are of equal weight.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|5 years||2019-12-31|12/2019||||
2627076|NCT01894152|Other Pre-specified|Number of All Death (Cardiac, Vascular, and Non-cardiovascular)|"Cardiac death:is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) This study as no primary or secondary endpoints, all endpoints are of equal weight.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|4 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627077|NCT01894152|Other Pre-specified|Number of All Death (Cardiac, Vascular, and Non-cardiovascular)|"- Cardiac death:is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~This study as no primary or secondary endpoints, all endpoints are of equal weight.~- Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|3 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627078|NCT01894152|Other Pre-specified|Number of All Death (Cardiac, Vascular, and Non-cardiovascular)|"Cardiac death:is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) This study as no primary or secondary endpoints, all endpoints are of equal weight.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|0 to 790 days|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627089|NCT01894152|Other Pre-specified|Number of Participants With Target Lesion Failure (TLF)|"Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).~This study as no primary or secondary endpoints, all endpoints are of equal weight."|≤ 7 days after index procedure (Hospitalization)|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627388|NCT01890694|Secondary|Renal Function [BUN and Creatinine Laboratory Results]|Improved renal function from baseline|Day 1 to Post-discharge (6 months)|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
2627079|NCT01894152|Other Pre-specified|Number of All Death (Cardiac, Vascular, and Non-cardiovascular)|"Cardiac death:is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) This study as no primary or secondary endpoints, all endpoints are of equal weight.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|≤ 7 days after index procedure (Hospitalization)|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627080|NCT01894152|Other Pre-specified|Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)|"Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR).~This study as no primary or secondary endpoints, all endpoints are of equal weight."|5 years||2019-12-31|12/2019||||
2627081|NCT01894152|Other Pre-specified|Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)|"Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR).~This study as no primary or secondary endpoints, all endpoints are of equal weight."|4 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627082|NCT01894152|Other Pre-specified|Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)|"Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR).~This study as no primary or secondary endpoints, all endpoints are of equal weight."|3 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time|||Participants|||Count of Participants
2627083|NCT01894152|Other Pre-specified|Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)|"Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR).~This study as no primary or secondary endpoints, all endpoints are of equal weight."|0 to 790 days|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627084|NCT01894152|Other Pre-specified|Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)|"Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR).~This study as no primary or secondary endpoints, all endpoints are of equal weight."|≤ 7 days after index procedure (Hospitalization)|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627085|NCT01894152|Other Pre-specified|Number of Participants With Target Lesion Failure (TLF)|"Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).~This study as no primary or secondary endpoints, all endpoints are of equal weight."|5 years||2019-12-31|12/2019||||
2627086|NCT01894152|Other Pre-specified|Number of Participants With Target Lesion Failure (TLF)|"Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).~This study as no primary or secondary endpoints, all endpoints are of equal weight."|4 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627087|NCT01894152|Other Pre-specified|Number of Participants With Target Lesion Failure (TLF)|"Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).~This study as no primary or secondary endpoints, all endpoints are of equal weight."|3 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627088|NCT01894152|Other Pre-specified|Number of Participants With Target Lesion Failure (TLF)|"Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).~This study as no primary or secondary endpoints, all endpoints are of equal weight."|0 to 790 days|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627389|NCT01890694|Secondary|Ascites|Improved control of ascites|Day 1 to Post-discharge (6 months)|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
2627090|NCT01894152|Other Pre-specified|Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)|"All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|5 years||2019-12-31|12/2019||||
2627091|NCT01894152|Other Pre-specified|Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)|"All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|4 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627092|NCT01894152|Other Pre-specified|Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)|"All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|3 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627093|NCT01894152|Other Pre-specified|Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)|"All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|0 to 790 days|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627094|NCT01894152|Other Pre-specified|Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)|"All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|≤ 7 days after index procedure (Hospitalization)|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627095|NCT01894152|Other Pre-specified|Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction.~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|5 years||2019-12-31|12/2019||||
2627096|NCT01894152|Other Pre-specified|Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction.~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|4 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627146|NCT01893801|Secondary|Progression-Free Survival|Progression-free survival is defined as the time from study enrollment until the first documented tumor progression (using RECIST 1.1 criteria) or death from any cause.|Over the course of the subjects' treatment and participation in study, approx 18 mos|All patients were evaluated for progression-free survival.|||months||95% Confidence Interval|Median
2627390|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Months 2-6 post-discharge|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
2627097|NCT01894152|Other Pre-specified|Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction.~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|3 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627098|NCT01894152|Other Pre-specified|Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Myocardial Infarction (MI): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction.~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|0 to 790 days|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627099|NCT01894152|Other Pre-specified|Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Myocardial Infarction (MI): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction.~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|≤ 7 days after index procedure (Hospitalization)|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627100|NCT01894152|Other Pre-specified|Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints|"All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|5 years||2019-12-31|12/2019||||
2627101|NCT01894152|Other Pre-specified|Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints|"All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|4 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627102|NCT01894152|Other Pre-specified|Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints|"All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|3 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627147|NCT01893801|Secondary|Overall Survival|Overall survival is defined as the time from study enrollment until death from any cause.|Over the course of the subjects' treatment and participation in study, approx 18 mos|All patients were evaluated for overall survival.|||months||95% Confidence Interval|Median
2627391|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Week 1-4 Post-discharge|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
2627103|NCT01894152|Other Pre-specified|Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints|"All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|0 to 790 days|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627104|NCT01894152|Other Pre-specified|Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints|"All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death.~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|≤ 7 days after index procedure (Hospitalization)|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627105|NCT01894152|Other Pre-specified|Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|5 years||2019-12-31|12/2019||||
2627106|NCT01894152|Other Pre-specified|Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint|"This Study Has no Primary or Secondary Endpoints, All Endpoints Are of Equal Weight.~Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|4 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627107|NCT01894152|Other Pre-specified|Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|3 years|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627108|NCT01894152|Other Pre-specified|Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|0 to 790 days|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627148|NCT01893801|Secondary|Percentage Change in CA 19-9|Percentage change in CA 19-9 from baseline values|Over the course of the subjects' treatment on study, approx 1 year|All patients with a non-zero CA 19-9 measurement at baseline and at least one CA 19-9 measurement on-study were evaluated for percentage change of CA19-9. Of the 25 patients on study, 22 met the criteria for analysis (one had baseline CA 19-9 of zero; two had no post-baseline CA 19-9 measurements).|||percentage change CA 19-9 from baseline||Standard Deviation|Mean
2627738|NCT01885910|Secondary|Oiliness|the oiliness severity scale ranges from 0 to 10 with 0 being no oiliness and 10 being most extreme oiliness|every 4 weeks|participants with data|||units on a scale||Standard Deviation|Mean
2627109|NCT01894152|Primary|Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded.~(This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~Myocardial Infarction (MI):~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.~This study as no primary or secondary endpoints, all endpoints are of equal weight."|≤ 7 days after index procedure (Hospitalization)|Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.|||Participants|||Count of Participants
2627110|NCT01894100|Secondary|Change in Lower Extremity Physical Function|For self-reported lower extremity physical function: Western Ontario and McMasters Universities Osteoarthritis Index physical function subscale. The physical function subscale includes 17 items that ask about difficulty with stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, and light household duties. Participants rate each item on a scale of 0-4 (no difficulty to extreme difficulty. Totals scores for this subscale range from 0-68 (no difficulty to extreme difficulty).|Baseline and 3 months post intervention||||units on scale||Standard Deviation|Mean
2627111|NCT01894100|Primary|Change in Pain Intensity|Western Ontario and McMasters Universities Osteoarthritis Index pain subscale is a 5 item questionnaire that asks participants to rate their pain during walking, using stairs, in bed, sitting or lying, and standing. Each item is rated by the participant as 0-4 (no pain to extreme pain). Total scores on the pain subscale range from 0 to 20 (no pain to extreme pain).|Baseline and 3 months after initiating intervention||||units on a scale||Standard Deviation|Mean
2627112|NCT01894087|Secondary|Substance Use - Current Opioid Misuse Measure|"This measure contained 8 items from the Current Opioid Misuse Measure. Items were assessed on a scale of never (0), rarely (1), sometimes (3), often (4), and very often (5). A sum score took a range of 0 to 40, with higher numbers indicating more non-medical opioid use. For group means reported here, change scores were calculated by subtracting the baseline level of this measure from the level at 6 months follow-up. This change score has a possible range of -40 to 40, with lower values indicating greater decreases in non-medical opioid use."|6 months post-baseline|Participants retained at follow-up and with complete item data on this measure at both baseline and follow-up|||Scores on a scale||95% Confidence Interval|Mean
2627113|NCT01894087|Primary|Behavioral Intentions|Behavioral intentions were assessed with three items that measured participant's intention to use overdose risk reduction strategies. The three strategies were (1) using opioids as prescribed, (2) reducing or avoiding use of alcohol, drugs, or non-prescribed medications, and (3) avoiding combining substances. Each item was assessed on a scale of 1 to 10, with higher numbers indicating greater intention to avoid overdose risk.|6 months post-baseline|Participants retained at follow-up and with complete item data on the outcome at baseline and follow-up|||Scores on a scale||95% Confidence Interval|Mean
2627114|NCT01894087|Primary|Overdose Knowledge|"Overdose symptom knowledge was assessed using an inventory of 5 true symptoms and 2 false symptoms of overdose, and the total score created as the sum of correct answers, with a range of 0 to 7. Due to the skewed distribution, this total score was standardized by subtracting the observed responses from the overall sample mean, and then dividing by the standard deviation. This resulted in a range of -5.4 to 2.6 in this sample at the 6 month follow-up, with higher numbers indicating greater overdose symptom knowledge. Also reported here are change scores generated by subtracting the standardized sum score at 6 months from the baseline standardized sum score, which had a range of -3.0 to 6.4 in this sample. Thus, higher numbers in this change variable indicated greater improvements in overdose symptom knowledge. Negative numbers would represent a decrease in symptom knowledge."|6 months post-baseline|Participants retained and follow-up and with complete data on the outcome measure items at baseline and follow-up.|||Scores on a scale||95% Confidence Interval|Mean
2627115|NCT01894087|Primary|Overdose Risk Behavior|This scale is a total sum of 9 items assessing participant's self-report of engaging in behavior that increases risk for overdose. Higher scores indicate greater risk for overdose. The range for this measure is 0 to 28 in one assessment. Results reported here as group means are for the change in sum score between baseline and follow-up, which had a possible range of -28 to 28, with lower values indicating greater decreases in overdose risk behavior.|6 months post-baseline|Participants who were retained at follow-up and had complete data for all items for this measure at baseline and follow-up|||Scores on a scale||95% Confidence Interval|Mean
2627116|NCT01894022|Secondary|Time to First Addition of Another Targeted PAH Therapeutic Agent Due to Deterioration of Clinical Condition or Lack of Beneficial Effect With Previous Therapy in Any Participant|"The time to addition of another targeted PAH therapeutic agents (prostanoids, PDE-5 inhibitors) due to the following reasons:~Deterioration of clinical condition; Lack of beneficial effect with previous therapy (not reaching set treatment goals). PAH therapies were collected, but after the study was terminated, not all endpoints listed in the protocol were analyzed, including time to first addition of another targeted PAH therapeutic agent. This decision was documented in the reporting and analysis plan prior to database lock."|From Entry visit of the extension study up to End of Study (assessed up to approximately 16 months)|Safety (Extension) Population.||||||
2627117|NCT01894022|Secondary|Time to First Change in Dose of Open-label Ambrisentan Due to Deterioration of Clinical Conditions in Any Participant|The time to change in dose of ambrisentan or other targeted PAH therapeutic agents (prostanoids, PDE-5 inhibitors) due to deterioration of clinical condition. Dosing data were collected, but after the study was terminated, not all endpoints listed in the protocol were analyzed, including time to first change in dose of open-label ambrisentan. This decision was documented in the reporting and analysis plan prior to database lock.|From Entry visit of the extension study up to End of Study (assessed up to approximately 16 months)|Safety (Extension) Population||||||
2657972|NCT01601977|Secondary|Control of Nocturnal Hypoventilation|mean tcCO2|2 weeks||||kPa||Standard Deviation|Mean
2627118|NCT01894022|Secondary|Percent Change From Start of Ambrisentan Treatment in Plasma N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)|The NT-proBNP data in a previous outcome measure were also analyzed as change from start of ambrisentan treatment. The ratio to start of ambrisentan in NT-proBNP was calculated as the ratio of the value at the specified time-point to the start of ambrisentan value and was expressed as a percent change from start of ambrisentan. This was done by taking the mean change on the log scale, exponentiating, subtracting 1 and multiplying by 100. Standard deviation (SD) of the logged values (log[SD]) have been presented. As par. started to receive ambrisentan treatment in 2 studies, 2 different time points for start of ambrisentan treatment were used for this analysis. For par. who received ambrisentan treatment in study AMB115811, the Baseline for that study was used. For par. who received placebo in Study AMB115811, entry visit of the Extension study was defined as Baseline. Only those par. available at the specified time points were analyzed (represented by n=X, X in the category title).|Previous Placebo: Months 0 (Entry visit of the extension), 1, 3, 6, 9, 12; Previous Ambrisentan: Month 0 (Baseline of study AMB115811), 1, 2, 3, 4, Early Withdrawal (EW) (AMB115811), 5, 7, 10, 13, 16, 19; and at End of Study|ITT Population. Placebo arm: includes par. who received ambrisentan treatment during extension study|||Percent change||Standard Deviation|Geometric Mean
2627119|NCT01894022|Secondary|Change From Start of Ambrisentan Treatment in Borg CR10 Scale (BCR10S) Immediately Following Exercise at the Indicated Time Points|"The BCR10S data in a previous outcome measure were also analyzed as change from start of ambrisentan treatment. BCR10S score, a rating of perceived exertion, ranges from 0 to 10 (0=nothing at all, 10 extremely strong). If par.'s perception or feeling was stronger than 10, a larger number could be used. As participants started to receive ambrisentan treatment in two studies, two different time points for start of ambrisentan treatment were used for this analysis. For participants who received ambrisentan treatment in Study AMB115811, the Baseline for that study was used. For participants who received placebo in Study AMB115811, entry visit of the Extension study was defined as Baseline. Change from start of ambrisentan was calculated as the value at the indicated visit minus the start of ambrisentan value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category title)."|Previous Placebo: Months 0 (Entry visit of the extension), 1, 3, 6, 9, 12; Previous Ambrisentan: Month 0 (Baseline of study AMB115811), 1, 2, 3, 4, Early Withdrawal (EW) (AMB115811), 5, 7, 10, 13, 16, 19; and at End of Study|ITT Population. Placebo arm: includes par. who received ambrisentan treatment during extension study|||Scores on a scale||Inter-Quartile Range|Median
2627120|NCT01894022|Secondary|Change From Start of Ambrisentan Treatment in World Health Organization (WHO) Functional Class (FC) at the Indicated Time Points|The WHO functional class data in a previous outcome measure were also analyzed as change from start of ambrisentan treatment. There are 4 grades for WHO FC based on severity of symptoms of pulmonary arterial hypertension (Class I = none, Class IV = most severe). Grades mapped to numeric scale 1-4 (i.e. Class IV = 4). As participants started to receive ambrisentan treatment in two studies, two different time points for start of ambrisentan treatment were used for this analysis. For participants who received ambrisentan treatment in Study AMB115811, the Baseline for that study was used. For participants who received placebo in Study AMB115811, entry visit of the Extension study was defined as Baseline. Change from start of ambrisentan was calculated as the value at the indicated visit minus the start of ambrisentan value (positive change = worsening). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Previous Placebo: Months 0 (Entry visit of the extension), 1, 3, 6, 9, 12; Previous Ambrisentan: Month 0 (Baseline of study AMB115811), 1, 2, 3, 4, Early Withdrawal (EW) (AMB115811), 5, 7, 10, 13, 16, 19; and at End of Study|ITT Population. Placebo arm: includes par. who received ambrisentan treatment during extension study|||Scores on a scale||Inter-Quartile Range|Median
2627121|NCT01894022|Secondary|Change From Start of Ambrisentan Treatment in 6 Minutes Walking Distance at the Indicated Time Points|The 6 minute walk distance data in a previous outcome measure were also analyzed as change from start of ambrisentan treatment. As participants started to receive ambrisentan treatment in two studies, two different time points for start of ambrisentan treatment were used for this analysis. For participants who received ambrisentan treatment in Study AMB115811, the Baseline for that study was used. For participants who received placebo in Study AMB115811, entry visit of the Extension study was defined as Baseline. Change from start of ambrisentan was calculated as the value at the indicated visit minus the start of ambrisentan value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category title).|Previous Placebo: Months 0 (Entry visit of the extension), 1, 3, 6, 9, 12; Previous Ambrisentan: Month 0 (Baseline of study AMB115811), 1, 2, 3, 4, Early Withdrawal (EW) (AMB115811), 5, 7, 10, 13, 16, 19; and at End of Study|ITT Population. Placebo arm: includes par. who received ambrisentan treatment during extension study|||Meters||Inter-Quartile Range|Median
2627122|NCT01894022|Secondary|Percent Change From Study AMB115811 Baseline in Plasma N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)|The ratio to Baseline in NT-proBNP was calculated as the ratio of the value at the specified time-point to the AMB115811 Baseline value and was expressed as a percent change from AMB115811 Baseline. This was done by taking the mean change on the log scale, exponentiating, subtracting 1 and multiplying by 100. Standard deviation (SD) of the logged values (log[SD]) have been presented. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. For the Extension study, the visit schedule (Months 1, 3, 6, 9, 12 and 15) was mapped to the visit schedule (Months 5, 7, 10, 13, 16 and 19) for continuity with study AMB115811. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|During Study AMB115811: Months 0 (Baseline), 1, 2, 3, 4, Early Withdrawal (EW); During Extension Study: Months 1, 3, 6, 9, 12, 15 and at End of Study (assessed up to approximately 20 months)|ITT Population|||Percent change||Standard Deviation|Geometric Mean
2627149|NCT01893801|Secondary|Treatment-Related Toxicities|Frequency of treatment-related toxicities|Over the course of the subjects' treatment on study, approx 1 year|All patients on study were evaluated for maximum grade of treatment-related toxicity.|||Participants|||Count of Participants
2627392|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|participants will be followed for the duration of hospital stay, an expected average of 2 weeks|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
2627123|NCT01894022|Secondary|Change From Study AMB115811 Baseline in Quality of Life as Measured by Short Form 36 Health Survey (SF-36)|The SF-36 version 2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health as well as 2 summary measures (Physical Health and Mental Health). Each domain is scored from 0 (poorer health) to 100 (better health). Baseline of study AMB115811 was to be used. Change from study AMB115811 Baseline was to be calculated as the value at the indicated visit minus the Baseline value. The SF-36 data were collected, but after the study was terminated, not all endpoints listed in the protocol were analyzed, including the SF-36. This decision was documented in the reporting and analysis plan prior to database lock.|Baseline from study AMB115811 up to End of Study for the extension study (assessed up to approximately 20 months)|ITT Population||||||
2627124|NCT01894022|Secondary|Number of Participants With Clinical Worsening of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)|Time to clinical worsening of CTEPH was defined as the time from randomization in study AMB115811 to the first occurrence of any of the following events: death (all cause), lung transplantation, hospitalization for CTEPH deterioration, atrial septostomy, addition of parenteral prostanoids, appearance of two or more CTEPH worsening events. Worsening events included: >=20% of decrease in 6MWD; >=1 increase of WHO Functional Classes; worsening right ventricular failure; rapidly progressing cardiogenic, hepatic, or renal failure; refractory systolic hypotension (SBP <85 mmHg).|From randomization up to End of Study for the extension study (assessed up to approximately 20 months)|ITT Population|||Participants|||Number
2627125|NCT01894022|Secondary|Change From Study AMB115811 Baseline in Borg CR10 Scale (BCR10S) Immediately Following Exercise at the Indicated Time Points|"BCR10S score, a rating of perceived exertion, was collected immediately following completion of the 6-minute walk test. Scores range from 0 to 10 (0=nothing at all, 10=extremely strong). If par.'s perception or feeling was stronger than 10, that is extremely strong, Maximal -a larger number could be used, for example 12 or still higher, that is Absolute maximum). AMB115811 BL data was calculated as average of 2 BCR10S values obtained following the 2 6MWD tests used in determining the BL 6MWD in that study. If only 1 measurement was available, it was used. Change from AMB115811 BL was calculated as the value at the indicated visit minus the BL value. Par.'s final visit in AMB115811 was used as the entry visit of ext study. For the Ext study, the visit schedule (M1,3,6,9,12 and 15) mapped to the visit schedule (M5,7,10,13,16 and 19) for continuity with AMB115811. Only those par. available at the specified time points were analyzed (represented by n=X,X in the category titles)."|During Study AMB115811: Months (M) 0 (Baseline), 1, 2, 3, 4, Early Withdrawal (EW); During Extension (Ext) Study: Months 1, 3, 6, 9, 12, 15 and at End of Study (assessed up to approximately 20 months)|ITT Population|||Scores on a scale||Inter-Quartile Range|Median
2627126|NCT01894022|Secondary|Change From Study AMB115811 Baseline (BL) in World Health Organization (WHO) Functional Class (FC) at the Indicated Time Points|WHO FC indicates severity of pulmonary arterial hypertension (PAH) and is an adaptation of the New York Heart Association classification, assessed by the investigator. There are 4 grades for WHO FC based on severity of symptoms (Class I = none, Class IV = most severe). Grades mapped to numeric scale 1-4 (i.e. Class IV = 4). WHO FC system links symptoms with activity limitations, allowing clinicians to predict disease progression and prognosis. AMB115811 BL is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 BL was calculated as the value at the indicated visit minus the BL value (positive change = worsening). Par.'s final visit in AMB115811 was used as entry visit of this ext study. For Ext study, the visit schedule (M1,3,6,9,12 and 15) was mapped to the visit schedule (M5,7,10,13,16 and 19) for continuity with study AMB115811. Only par. available at the specified TP were analyzed (represented by n=X,X in the category title).|During Study AMB115811: Months (M) 0 (Baseline), 1, 2, 3, 4, Early Withdrawal (EW); During Extension (ext) Study: Months 1, 3, 6, 9, 12, 15 and at End of Study (assessed up to approximately 20 months)|ITT Population|||Scores on a scale||Inter-Quartile Range|Median
2627127|NCT01894022|Secondary|Change From Study AMB115811 Baseline in the 6 Minutes Walking Distance (6MWD) at the Indicated Time Points|The 6-minute walk test was conducted according to the American Thoracic Society guidelines in accordance with local standard operating procedures. 6MWD was measured by a 6-minute walk test. This test measures the distance that a par. can walk in a period of 6 minutes. AMB115811 Baseline was the Week 0 value in that study. Change from study AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Par.'s final visit in study AMB115811 was used as the entry visit of this extension study. For the Extension study, the visit schedule (Months 1, 3, 6, 9, 12 and 15) was mapped to the visit schedule (Months 5, 7, 10, 13, 16 and 19) for continuity with study AMB115811. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Intent-to-treat (ITT) Population: all par. who were randomized and took at least one dose of study medication in the double-blind phase (placebo or ambrisentan).|During Study AMB115811: Months 0 (Baseline), 1, 2, 3, 4, Early Withdrawal (EW); During Extension Study: Months 1, 3, 6, 9, 12, 15 and at End of Study (assessed up to approximately 20 months)|ITT Population|||Meters||Inter-Quartile Range|Median
2627128|NCT01894022|Primary|Time to First Change in Dose of Open-label Ambrisentan Due to Tolerability Issues in Any Participant|The time to change in dose of ambrisentan or other targeted PAH (pulmonary arterial hypertension) therapeutic agents (prostanoids, PDE-5 inhibitors) due to tolerability issues (e.g. adverse events). Dosing data were collected, but after the study was terminated, not all endpoints listed in the protocol were analyzed, including time to first change in dose of open-label ambrisentan. This decision was documented in the reporting and analysis plan prior to database lock.|From the Entry visit of the extension study up to approximately 16 months|Safety (Extension) Population||||||
2627201|NCT01892709|Post-Hoc|"Mean Pain Intensity Score in Numerical Rating Scale (NRS) Units at Each Time Point, Based on Response to the Question, Do You Want More Pain Medication?"|"Pain intensity is measured on the numerical rating scale (NRS) with scores from 0 (no pain) to 10 (worst pain imaginable).~Time points 2, 3, and 4 are dependent on patient response to Do you want more pain medication? Time 1 is 30 min post-baseline. For those who answer no at Time 1, Time 2 is 30 minutes later (at 1 hour), and for those who answer yes, Time 2 is 30 minutes after additional pain medication is given. This pattern follows for Time 3 and 4, with a total study time of 4 hours"|4 hours||||units on a scale||Full Range|Mean
2631299|NCT01845831|Secondary|Total Daily Insulin Dose|Daily insulin requirement (units per day).|Duration of Hospitalization (Up to 10 Days)||||units per day||Standard Error|Mean
2627129|NCT01894022|Primary|Change From Study AMB115811 Baseline in Weight at the Indicated Time Points|Weight was measured at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and at end of study. Change from study AMB115811 Baseline in weight is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population|||kilogram (kg)||Inter-Quartile Range|Median
2627130|NCT01894022|Primary|Change From Study AMB115811 Baseline in Heart Rate at the Indicated Time Points|Vital signs including heart rate were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in heart rate is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population|||beats per minute||Inter-Quartile Range|Median
2627131|NCT01894022|Primary|Change From Study AMB115811 Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Assessed at the Indicated Time Points|Vital signs including SBP and DBP were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in SBP and DBP is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population|||millimeter of mercury (mmHg)||Inter-Quartile Range|Median
2627132|NCT01894022|Primary|Number of Participants With Creatinine Values of Potential Clinical Concern at Any Time Post Entry Visit|Blood samples were collected at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study plus any unscheduled lab tests for creatinine. A creatinine value of potential clinical concern high was defined as >=176.8 micromoles per Liter. Participants with both normal and high values were counted once under their worst case (high). Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study.|Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study plus any unscheduled lab tests (assessed up to approximately 16 months)|Safety (Extension) Population|||Participants|||Number
2627133|NCT01894022|Primary|Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern at Any Time Post Entry Visit|Blood samples were collected post Entry visit of the extension study and up to end of study for evaluation of the clinical chemistry parameters of alanine amino transferase (ALT), aspartate amino transferase (AST), gamma glutamyl transferase (GGT), and total bilirubin. The clinical chemistry parameters of potential clinical concern high were defined as follows: ALT, AST, GGT >=3 times upper limit of normal (ULN); total bilirubin >=2 times ULN. Participants with both normal and high values were counted once under their worst case (high). Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study.|Post entry visit of the extension study and up to End of Study (assessed up to approximately 16 months)|Safety (Extension) Population|||Participants|||Number
2627134|NCT01894022|Primary|Change From Study AMB115811 Baseline in Red Blood Cell Count and Reticulocytes at the Indicated Time Points|Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in red blood cell count and reticulocytes is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population|||Tera per Liter (TI/L)||Inter-Quartile Range|Median
2627135|NCT01894022|Primary|Change From Study AMB115811 Baseline in Mean Corpuscle Volume at the Indicated Time Points|Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in mean corpuscle volume is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population|||Femtoliter (fL)||Inter-Quartile Range|Median
2627202|NCT01892709|Post-Hoc|"Number of Patients Responding to the Question, Do You Want More Pain Medication? at Each Time Point"|"Time points 2, 3, and 4 are dependent on patient response to Do you want more pain medication? Time 1 is 30 min post-baseline. For those who answer no at Time 1, Time 2 is 30 minutes later (at 1 hour), and for those who answer yes, Time 2 is 30 minutes after additional pain medication is given. This pattern follows for Time 3 and 4, with a total study time of 4 hours"|4 hours||||Participants|||Count of Participants
2627136|NCT01894022|Primary|Change From Study AMB115811 Baseline in Hematocrit at the Indicated Time Points|Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in hematocrit is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population|||Ratio||Inter-Quartile Range|Median
2627137|NCT01894022|Primary|Change From Study AMB115811 Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points|Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in hemoglobin and MCHC is summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in Study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population|||Grams per Liter (g/L)||Inter-Quartile Range|Median
2627138|NCT01894022|Primary|Change From Study AMB115811 Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Absolute Neutrophil Count [ANC]), Platelet Count, and White Blood Cell (WBC) Count at the Indicated Time Points|Hematology parameters were assessed at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study. Change from study AMB115811 Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC), platelet count, and WBC count are summarized. AMB115811 Baseline is the last value recorded on or prior to start of study treatment in that study. Change from AMB115811 Baseline was calculated as the value at the indicated visit minus the Baseline value. Participant's final visit in Study AMB115811 was used as the entry visit of this open-label extension study. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). NA indicates that data were not available.|Baseline from study AMB115811; Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study (assessed up to approximately 16 months)|Safety (Extension) Population|||Giga per Liter (GI/L)||Inter-Quartile Range|Median
2627139|NCT01894022|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect. Refer to the general AE/SAE module for a list of AEs and SAEs. Participant's final visit in Study AMB115811 was used as the entry visit of this open-label extension study. Safety (Extension) Population: all participants who enrolled and took at least one dose of study treatment during the extension study.|From entry visit of the extension study up to approximately 16 months|Safety (Extension) Population|||Participants|||Number
2627140|NCT01893983|Other Pre-specified|Self-care Activities|Five types of self-care activities to relieve stress: internet or mobile applications, community groups (church groups, gun clubs), community classes (Yoga, cooking), alternative treatments (acupuncture, chiropractor, massage), and other self-care activities (meditation, fishing, walking).|26 months|Including participants who responded to survey questions during follow-up.|||Participants|||Count of Participants
2627141|NCT01893983|Other Pre-specified|Mental Health Symptoms, Substance Use Scores and Quality of Life (QOL) Measures.|"Depression, anxiety, panic, PTSD, tobacco, alcohol, cannabis, cocaine, amphetamine, inhalants, sedatives, hallucinogen, opioid, and QOL domains: physical health, psychological health, social relationships, and environment.~Ranges of scores: depression: 0-27, anxiety: 0-4, panic: 0-4, PTSD: PTSD: 0-80., tobacco: 0-31, alcohol: 0-39, cannabis use: 0-39, cocaine: 0-39, amphetamine: 0-39, inhalants: 0-39, sedatives: 0-39, hallucinogen: 0-39, opioid: 0-39, QOL physical health: 4-20, QOL psychological health: 4-20, QOL social relationships: 4-20, QOL environment: 4-20.~Higher scores mean worse outcomes for mental health symptoms and substance use scores; higher scores mean worse outcomes for quality of life measures."|26 months|Including patients who reported mental health symptoms, substance use, and quality of life.|||score on a scale||Standard Deviation|Mean
2627142|NCT01893983|Secondary|Mental Health (MH) Treatment Retention|Motivational Coaching (vs. Control) on MH treatment retention. This will be measured by self-report and by checking the subjects medical record. The investigators will adjust by clustering for CBOC and region as well as potential confounding by other covariates|26 months|Including patients who provided primary outcome data.|||Participants|||Count of Participants
2627143|NCT01893983|Primary|Mental Health (MH) Treatment Engagement|Motivational Coaching (vs. Control) on MH treatment initiation. This will be measured by self-report and by checking the subjects medical record. The investigators will adjust by clustering for CBOC and region as well as potential confounding by other covariates|26 months|Including 272 patients who provided primary outcome data (excluding those who withdrew).|||Participants|||Count of Participants
2627144|NCT01893905|Primary|Change in Pain According to VAS (0-100 mm)|VAS=The visual analogue scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, the patients specify their condition by indicating a position along a continuous line between two end-points. In our case a 0-100 mm line was used to define the degree of pain. The change between baseline and each evaluation visit (week 4, week 12 and week 24) was calculated to evaluate the efficacy of the treatments (a negative number represents a decrease in pain).|24 weeks||||units on a scale||Standard Deviation|Mean
2627145|NCT01893879|Primary|Number of Participants With Incidence of Lymphedema|Participants were evaluated every 3 months up to one year post lymph node dissection|Up to 1 year||||Participants|||Count of Participants
2627150|NCT01893801|Primary|Complete Response Rate|"The primary objectives of this study is to pursue treatment of 25 individual patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDA) to evaluate:~Complete response rate as defined by computed tomography (CT) scan using RECIST 1.1 criteria and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits (from at least > 2x ULN). We expect to accomplish this in > or = to 5% of patients. When a complete response (CR) is documented, a confirmatory PET scan will be obtained.~If 1 or more of 10 patients demonstrate a complete response (CR), study will continue to enroll to a total of 25 patients.~If intolerable adverse events or no clinical benefit are noted in the first 6 patients, study will discontinue enrollment."|1 yr.|Best Response on study was assessed for patients with at least one evaluation for response while evaluable during the study. One patient achieved CR 32 days after the last dose on therapy and had a best response of PR prior to this assessment. The patient is identified as having a best response of CR in this table.|||Participants|||Count of Participants
2627151|NCT01893632|Primary|Abstinence From Benzodiazepine Use|Achievement of two weeks abstinence from benzodiazepine use at end of trial|last two weeks of 12 week trial||||Participants|||Count of Participants
2627152|NCT01893567|Secondary|Subject Reported Effectiveness Scores||2 weeks|||||||
2627153|NCT01893567|Secondary|Investigator Reported Effectiveness Scores||2 weeks|||||||
2627154|NCT01893567|Primary|Subject Reported Target Lesion Severity Score.|Subject reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study.|2 weeks||||units on a scale||Standard Deviation|Mean
2627155|NCT01893411|Secondary|Occurrence of TEAEs Leading to Discontinuation Overall and Per Injection Cycle|Treatment-emergent Adverse Events (TEASs) are events observed from the time point of first injection until end of study visit (week 24-72). Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Participants|||Count of Participants
2627156|NCT01893411|Secondary|Occurrence of TEAEs by Final Outcome Overall and Per Injection Cycle|Treatment-emergent Adverse Events (TEAEs) are events observed from the time point of first injection until end of study visit (week 24-72). Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Participants|||Count of Participants
2627157|NCT01893411|Secondary|Occurrence of TEAEs by Worst Intensity Overall and Per Injection Cycle|Treatment-emergent Adverse Events (TEAEs) are events observed from the time point of first injection until end of study visit (week 24-72). Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Participants|||Count of Participants
2627158|NCT01893411|Secondary|Occurrence of TEAEs Related to Treatment as Assessed by the Investigator Overall and Per Injection Cycle|Treatment-emergent Adverse Events (TEAEs) are events observed from the time point of first injection until end of study visit (week 24-72). Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Participants|||Count of Participants
2627159|NCT01893411|Secondary|Occurrence of Serious TEAEs (TESAEs) Overall and Per Injection Cycle|Treatment-emergent Serious Adverse Events (TESAEs) are events observed from the time point of first injection until end of study visit (week 24-72). Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Participants|||Count of Participants
2627160|NCT01893411|Secondary|Occurrence of Participants With TEAEs of Special Interest (TEAESIs) Overall and Per Injection Cycle|Adverse Events (AE's) occurring after treatment that were thought to possibly indicate toxin spread throughout the trial conduct are defined as AE's of Special Interests. Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Participants|||Count of Participants
2627161|NCT01893411|Secondary|Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle|Treatment-emergent Adverse Events (TEAEs) are events observed from the time point of first injection until end of study visit (week 24-72). Values reported here refer to the number of participants affected.|Up to End of study visit (Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Participants|||Count of Participants
2627162|NCT01893411|Secondary|Time to Reinjection for Each of the Three Dose Groups for the First and Second Injection Cycle||Baseline up to Week 24-72|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Weeks||Standard Deviation|Mean
2627739|NCT01885910|Secondary|Peeling|the peeling severity scale ranges from 0 to 4 with 0 being no peeling and 4 being most extreme peeling|every four weeks|participants with data|||units on a scale||Standard Deviation|Mean
2627163|NCT01893411|Secondary|Change in Scores of Pain Intensity (From Participants) and Pain Frequency (From Parent/Caregiver) to All Post Baseline Visits of the First and of the Second Injection Cycle|"The QPS is a patient-reported outcome for children and adolescents (2-17 years) with cerebral palsy on spasticity-related pain. Pain intensity (from participants) and pain frequency (from parent/caregiver) to be assessed with 'Questionnaire on Pain caused by Spasticity [QPS]'. The QPS Total Score for pain intensity ranges from 0 ('No Hurt') to 10 ('Hurt Worst'). The QPS Total Score for the observed pain frequency ranges from 0 (Never) to 4 (Always).~Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline to Week 4, 8, and 12 of 1st IC and 2nd IC (Week 16-40, 20-44 and 24-48)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Units on a scale||Standard Error|Least Squares Mean
2627164|NCT01893411|Secondary|Changes From Baseline in Gross Motor Function Measure [GMFM]-66 Score at the End of First Injection Cycle and at the End of Study Visit|"The GMFM-66 is a standardized observational 66-item instrument designed and validated to measure change in gross motor function over time in participants with cerebral palsy. Score values represent the total GMFM-66 score. Total GMFM scores range from 0 (worst) to 100 (best).~Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline to Week 12-36 of 1st IC and 2nd IC (End of study = Week 24-72)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Units on a scale||Standard Error|Least Squares Mean
2627165|NCT01893411|Secondary|Investigator's Global Impression of Change of GICS-Plantar-Flexor of Primary Body Side at Day 29 (Week 4) of the First and Second Injection Cycle|"The GICS are global outcomes to assess the impression of change due to treatment. GICS were assessed by the investigator, by the participant (if feasible) and by parents'/caregiver (if applicable). GICS are 7-Point Likert Scales ranging from +3 (very much improved function) to -3 (very much worse function). For participants with bilateral pes equinus, the body side for primary efficacy analysis i.e. primary body side was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study.~Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline to Week 4 of 1st IC and 2nd IC (Week 16-40)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Units on a scale||Standard Error|Least Squares Mean
2627166|NCT01893411|Secondary|Investigator's, Child's/Adolescent's, and Parent's/Caregiver's Global Impression of Change Scale [GICS] at Day 29 (Week 4) of the First and Second Injection Cycle|"The Global Impression of Change Scales (GICS) are global outcomes to assess the impression of change due to treatment. GICS were assessed by the investigator, by the participant (if feasible) and by parents'/caregiver (if applicable). GICS are 7-Point Likert Scales ranging from +3 (very much improved function) to -3 (very much worse function).~Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from MMRM (Mixed Model Repeated Measurement) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline to Week 4 of 1st IC and 2nd IC (Week 16-40)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Units on a scale||Standard Error|Least Squares Mean
2627167|NCT01893411|Secondary|Changes From Baseline in Modified Tardieu Scale [MTS] of Plantar Flexors of Primary Body Side at Day 29 (Week 4), Day 57 (Week 8), and Day 85 (Week 12) of the First and of the Second Injection Cycle|"The Modified Tardieu Scale (MTS) assesses spastic muscle tone by subtraction of two angles measured at different conditions of passive muscle stretch. R2 is the angle of passive range of motion with a passive movement at slow speed. R1 is the angle where a catch-and-release or clonus can be triggered at the fastest possible speed. Score values represent the measured (R2-R1) difference, i.e. the dynamic tone component of the examined muscle(s). Decreases of (R2-R1) represent reductions in the dynamic component of spasticity, i.e. improvement of dynamic muscle spasticity.~Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the model used for comparison and are therefore provided separately for each comparison."|Baseline to Week 4, 8, and 12 of 1st IC and 2nd IC (Week 16-40, 20-44 and 24-48)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Angle||Standard Error|Least Squares Mean
2627203|NCT01892709|Secondary|Adverse Events and Side Effects by Total Amount of Hydromorphone Received||120 min|Nausea and vomiting were only assessed as adverse events among patients who did not have nausea and vomiting before the study began|||Participants|||Count of Participants
2627393|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Day 8|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
2627168|NCT01893411|Secondary|Changes From Baseline in AS Score of Knee Flexors or Thigh Adductors in Participants With Unilateral Treatment at Day 29 (Week 4) of the First and of the Second Injection Cycle|"The Ashworth Scale (AS) is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).~Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from MMRM (Mixed Model Repeated Measurement) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison.~KF = Knee Flexors; TA = Thigh Adductors; w = week."|Baseline to Week 4 of 1st IC and 2nd IC (Week 16-40)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Units on a scale||Standard Error|Least Squares Mean
2627169|NCT01893411|Secondary|Changes From Baseline in AS Score of Plantar Flexors of the Primary Body Side at Day 57 (Week 8) and Day 85 (Week 12) of the First and of the Second Injection Cycle|"The Ashworth Scale (AS) is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). For participants with bilateral pes equinus, the body side for primary efficacy analysis i.e. primary body side was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study.~Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from MMRM (Mixed Model Repeated Measurement) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline to Week 8 and 12 of 1st IC and 2nd IC (Week 20-44 and 24-48)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Units on a scale||Standard Error|Least Squares Mean
2627170|NCT01893411|Secondary|Change From Baseline in the AS Score of Plantar Flexors of the Primary Body Side at Day 29 (Week 4) of the Second Injection Cycle|"The Ashworth Scale (AS) is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). For participants with bilateral pes equinus, the body side for primary efficacy analysis i.e. primary body side was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study.~Values represent least square (LS) mean differences between baseline and Week 16-40 resulting from MMRM (Mixed Model Repeated Measurement) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline to Week 4 of 2nd IC (Week 16-40)|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Units on a scale||Standard Error|Least Squares Mean
2627171|NCT01893411|Secondary|Change From Baseline in the AS Score of Plantar Flexors of the Nonprimary Body Side in Participants With Bilateral Treatment at Day 29 (Week 4) of the First (1st) and Second Injection Cycle (2nd IC)|"The Ashworth Scale (AS) is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).~Values represent least square (LS) mean differences between baseline and the respective week (w) resulting from MMRM (Mixed Model Repeated Measurement) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline, Week 4 of 1st IC and Week 16-40 of 2nd IC|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Units on a scale||Standard Error|Least Squares Mean
2627172|NCT01893411|Primary|Co-primary Variable: Investigator's Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle|"This variable is classified as co-primary to satisfy a Food and Drug Administration (FDA) request. The GICS-PF scale is a 7-Point Likert Scale for the assessment of the functional change due to treatment of plantar flexor spasticity only. Ranges from +3 (very much improved function) to -3 (very much worse function). For participants with bilateral pes equinus, the body side for primary efficacy analysis i.e. primary body side was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study.~Values represent least square (LS) mean differences between baseline and Week 4 resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline, Week 4|FAS population is subset in the SES for whom the primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or the investigator’s GICS-PF [for participants with bilateral treatment on same body side] at Day 29 [Week 4] of the first injection cycle) were available.|||Units on a scale||Standard Error|Least Squares Mean
2627239|NCT01892267|Secondary|Gastrointestinal Quality of Life Index (GIQLI) Score|Gastrointestinal Quality of Life Index (GIQLI) score ranging from 0 (worst quality of life possible with severe digestive symptoms) to 144 (optimal quality of life without symptoms|3 month|The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that only 5 patients had a completed GIQLI questionnaire at 3-month follow-up.|||units on a scale||Full Range|Median
2627173|NCT01893411|Primary|Change From Baseline in the Ashworth Scale (AS) Score of Plantar Flexors of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle (1st IC)|"The Ashworth Scale (AS) is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (= no increase in tone) to 4 (=limb rigid in flexion or extension). For participants with bilateral pes equinus, the body side for primary efficacy analysis i.e. primary body side was decided by investigator at screening and was kept throughout the entire study. For participants with unilateral treatment, the treated body side was kept throughout the entire study.~Values represent least square (LS) mean differences between baseline and Week 4 resulting from MMRM (Mixed Model Repeated Measurement) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison."|Baseline, Week 4|FAS population is subset in the SES for whom primary efficacy variable (participants who had at least an AS score of plantar flexor at baseline [Day 1] or investigator’s Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) [participants with bilateral treatment on same body side] at Day 29 [Week 4] of the 1st IC) were available.|||Units on a scale||Standard Error|Least Squares Mean
2627174|NCT01893372|Secondary|Number of Participants Achieving a Platelet Response|Platelet response is Hematologic Improvement with platelet response (HI-P), defined as an absolute increase of >/= 30 x 10^9/L for patients starting with >20 x 10^9/L platelets or increase from <20 x 10^9/L to >20 x 10^9/L and by at least 100%|3 Years||||Participants|||Count of Participants
2627175|NCT01893372|Secondary|Number of Participants Transforming From Myelodysplastic Syndrome (MDS) to Acute Myeloid Leukemia (AML)||Up to 3 years, 3 months.||||Participants|||Count of Participants
2627176|NCT01893372|Primary|Overall Survival (OS)|Overall Survival (OS) was measured from the time of study enrollment until death from any cause or fate of the last follow-up.|Through study completion. Up to 3 years, 3 months.||||Weeks||Full Range|Median
2627177|NCT01893372|Primary|Overall Response Rate (ORR)|Overall response rate (ORR) based on the International Working Group (IWG)-2006 criteria, which include complete remission (CR), partial remission (PR), and major hematologic improvement (HI). Patients' overall response assessed after at least 2 cycles of treatment and no more than after 6 cycles of treatment and each cycle is 28 days. CR is Bone marrow of </= 5% myeloblasts with normal maturation of cell lines, persistent dysplasia and a hemoglobin >/= 11g/dl, platelets >/= 100x10^9/L, neutrophils >/= 1.0x10^9/L and 0% blasts. PR is the same as CR but bone marrow blasts decreased by >/=50% but still 5% over pre-treatment. HI is described by the number of individually affected cell lines. (E = Erythroid, N = Neutrophils, P = Platelet). HI-E is a 2 gram increase in hemoglobin. HI-N is at least a 100% increase or an absolute increase of more than 500/mm^3. HI-P is an absolute increase of 30/mm^3 or a 50% increase|After second 28 day cycle||||Participants|||Count of Participants
2627178|NCT01893359|Primary|MRSE Regression|The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months.|one week to twelve months|This trial had extremely low enrollment due to difficulties recruiting patients therefore no analysis was conducted.||||||
2627179|NCT01893359|Primary|MRSE Regression|The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months.|one week to six months|This trial had extremely low enrollment due to difficulties recruiting patients therefore no analysis was conducted. Data for MSRE were collected for the two treated patients the primary endpoint is a comparison between the treatment groups. The two patients were in the same treatment group so a comparison between groups is not possible.||||||
2627180|NCT01893346|Primary|Pharmacokinetic Parameters of Avibactam and Ceftazidime for Cohort 1 and 2: Cmax|Key PK parameters are shown for cohorts 1 and 2. For cohorts 3 and 4 (where children were <6 years of age), sparse sampling scheme was used for PK samples to limit the volume of blood required. PK parameters cannot be derived from these sparse PK samples without population PK analysis. Thus the PK is not described here, but will be reported in a separate population PK report.|Day 1|Pharmacokinetic analysis set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2627181|NCT01893346|Primary|Pharmacokinetic Parameters of Avibactam and Ceftazidime for Cohort 1 and 2: AUC|Key PK parameters were prespecified to be calculated for cohorts 1 and 2. For cohorts 3 and 4 (where children were <6 years of age), sparse sampling scheme was used for PK samples to limit the volume of blood required. PK parameters cannot be derived from these sparse PK samples without population PK analysis. Thus the PK is not described here, but will be reported in a separate population PK report.|Day 1|Pharmacokinetic analysis set|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2627182|NCT01893281|Secondary|Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Energy Level|"PGI-I for energy level is a participant-rated questionnaire that measures change in energy level after a participant begins the study drug. The questionnaire was completed at every visit post baseline using a 7-point scale where a score of 1 indicated that the participant's energy level was very much better, a score of 4 indicated that the participant had experienced no change in energy level and a score of 7 indicated that the participant's energy level was very much worse. Percentage of participants = (number of participants in the category) / (total number of participants who responded to the questionnaires) * 100."|Study Days 15, 22, 36, 43, 57, 64 and endpoint|All enrolled participants who received at least 1 dose of study drug and responded to PGI-I energy level questionnaire at specified time points. Endpoint is defined as the last non-missing PGI-I scale for energy level collected from Day 15 through end of study.|||percentage of participants|||Number
2627224|NCT01892345|Primary|Participants With An Adjudicated On-trial Relapse|An On-trial Relapse was defined as a new onset of neurologic symptoms or worsening of existing neurologic symptoms with an objective change (clinical sign) on neurologic examination that persisted for more than 24 hours as confirmed by the treating physician. An adjudicated On-trial Relapse was defined by the protocol and positively adjudicated by the relapse adjudication committee.|Baseline, Up To 211 Weeks (End of Study)|Full Analysis Set (FAS): all participants who were randomized to treatment, received at least 1 dose of study drug.|||Participants|||Count of Participants
2627183|NCT01893281|Secondary|Percentage of Participants in Each Category of the Patient Global Impression - Improvement (PGI-I) Scale for Sexual Drive|"PGI-I for sexual drive is a participant-rated questionnaire that measure change in sexual drive after a participant begins the study drug. The questionnaire was completed at every visit post baseline using a 7-point scale where a score of 1 indicated that the participant's sexual drive was very much better, a score of 4 indicated that the participant had experienced no change in sexual drive and a score of 7 indicated that the participant's sexual drive was very much worse. Percentage of participants = (number of participants in the category) / (total number of participants who responded to the questionnaire) * 100."|Study Days 15, 22, 36, 43, 57, 64 and endpoint|All enrolled participants who received at least 1 dose of study drug and responded to PGI-I sexual drive questionnaire at specified time points. Endpoint is defined as the last non-missing PGI-I scale for sexual drive collected from Day 15 through end of study.|||percentage of participants|||Number
2627184|NCT01893281|Secondary|Change From Baseline in Serum Testosterone Levels|Serum testosterone levels were measured by LC/MS-MS.|Baseline, Study Completion (Up to 9 Weeks)|All enrolled participants who received at least 1 dose of study drug with non-missing data at baseline and at least 1 post baseline measurement. Last-observation-carried-forward (LOCF) was used to impute missing data.|||ng/dL||Standard Deviation|Mean
2627185|NCT01893281|Primary|Percentage of Participants Achieving Normal Serum Testosterone Levels|Normal serum testosterone level is defined as ≥300 to ≤1050 nanograms/deciliter (ng/dL). Serum testosterone levels were measured by liquid chromatography and tandem mass spectrometry (LC/MS-MS). Percentage of participants = (number of participants who achieved normal serum testosterone level) / (number of treated participants who had serum testosterone level measured) * 100.|Baseline through Study Completion (Up to 9 Weeks)|All enrolled participants who received at least 1 dose of study drug and had serum testosterone level measurement.|||percentage of participants||95% Confidence Interval|Number
2627186|NCT01893203|Other Pre-specified|Adverse Reactions|Adverse reactions are evaluated by blinded observer at one week after treatment. A dermatologist will assess which side of the face or scalp presents a stronger reaction.|1 week|One week after the first photodynamic therapy (PDT), seven patients had more severe reactions (erythema, crusting) at the site treated with BF-200 ALA, five patients had more severe reactions at the MAL site and one patient showed no difference between sites.|||participants|||Number
2627187|NCT01893203|Secondary|Clinical Lesion Clearance|Clinical lesion clearance is observed by a blinded observer|3 months||||percentage of complete clearance|Participants|95% Confidence Interval|Number
2627188|NCT01893203|Secondary|Pain|"Pain using visual analog scale (VAS 0-10, where 0 is no pain and 10 is the worst pain imaginable) on both treatment sides is assessed in every 30 minutes during 2-hour sun-exposure and afterwards once in two hours until 9 p.m.~(treatment day). Of these values, the mean maximal pain is assessed."|12 hours|Patients|||units on a scale||Full Range|Mean
2627189|NCT01893203|Primary|Histological Lesion Clearance|Punch biopsies were taken symmetrically on both treatment fields from equally graded >6 mm AKs prior to treatment and again at 3 months, blinded observer (pathologist). HE- and p53-stainings. Samples not fulfilling the criteria of an AK were defined as healthy or completely cleared. The p53 reactivity expressed as average percentage of positive nuclei in three consecutive high power fields from the region of highest reactivity (<10 % normal)|0 (baseline) and 3 months|Punch biopsies bilaterally on treatment fields|||percentage of complete clearance|||Number
2627190|NCT01892865|Secondary|Complications: A Composite Endpoint of Death, Myocardial Infarction, Bleeding, Amputation|Comparison of the perioperative (30-day postoperative) composite endpoint of death, myocardial infarction, bleeding, amputation between the two study groups|Three years|Patients|||Participants|||Count of Participants
2627191|NCT01892865|Secondary|Operative Suite Personnel Job Satisfaction|Comparison of job satisfaction between study arms using three domains of the Maslach Burnout Inventory: Depersonalization (range 0-17, score of 17 indicates worse depersonalization). Emotional Exhaustion (range: 0-36, score of 36 is the worse). Personal accomplishment (range 1-60, score of 60 is best).|Three years|Health care providers|||units on a scale|Responses|Full Range|Mean
2627192|NCT01892865|Secondary|Difference in Throughput|Difference in total number of cases scheduled per unit of time analyzed between the two study arms|Three years|Operative days|||Operations/day analyzed|Operative Days||Number
2627193|NCT01892865|Primary|Difference Between the Actual and Predicted Length of Operative Day (in Minutes)|The scheduling imprecision between the two scheduling approaches will be compared. Scheduling imprecision is defined as the difference between the actual and predicted length of operative day.|Three years|We analyzed data from 107 operative days in the HM arm, and 100 days in the PMS arm|||Minutes||Standard Deviation|Mean
2627194|NCT01892722|Secondary|Pharmacokinetic/Pharmacodynamic Relationship for Fingolimod-P to Lymphocyte Levels|Population PK/PD modeling approaches were used to relate the individual fingolimod-P concentrations to lymphocyte counts.|24 months||2024-03-31|03/2024||||
2627195|NCT01892722|Secondary|Pharmacokinetics (Cavg) of Fingolimod-P|Cavg (average drug concentration over the dose interval) will be evaluated.|24 months||2024-03-31|03/2024||||
2627196|NCT01892722|Secondary|T1 Gd- Enhancing Lesions|Number of T1 Gd-enhancing lesions per scan up to Month 24|24 months||2024-03-31|03/2024||||
2627197|NCT01892722|Secondary|Proportion of Patients Relapse-free|Proportion of patients relapse-free was determined|24 months||2024-03-31|03/2024||||
2627198|NCT01892722|Secondary|Time to First Relapse|Time to first relapse was determined.|24 months||2024-03-31|03/2024||||
2627199|NCT01892722|Secondary|New/Newly Enlarged T2 Lesions|Annualized rate of the number of new/newly enlarged T2 lesions up to Month 24|24 months||2024-03-31|03/2024||||
2627200|NCT01892722|Primary|Frequency of Relapses in Patients Treated for up to 24 Months|Frequency of relapses assessed by the annualized relapse rate (ARR). The ARR is defined as the average number of confirmed relapses per year (total number of confirmed relapses divided by the total days in the study multiplied by 365.25).|24 months|Full analysis set (FAS): The FAS was comprised of all randomized patients with assigned treatments who received at least one dose of study medication.|||Confirmed relapse per year||95% Confidence Interval|Mean
2627237|NCT01892267|Secondary|Long-term Complications|Long-term complications will include stomal (Infection, erythema, bleeding, pain, secretion, abscess, etc) and tube (Clotting, dislocation, defect and aspiration, etc) complications detected more than one week after intervention.|2 years|Study terminated prematurely, so that the appropriate follow-up data was not collected.||||||
2627204|NCT01892709|Primary|Number of Participants Requesting Pain Medication in Different Patterns Over Time|"This is a descriptive hypothesis-generating trial, which is why it is not being compared in a randomized fashion to a comparison group. We are examining extended titration by expanding our 1+1 protocol to a 1+1+1+1 protocol and the various patterns of opioid request. For example, some may state no every time they are asked Do you want more pain medication? Some will state yes each time, and others will answer yes and no at different time periods. We will report these various patterns (i.e. X participants answered no everytime they were asked, Y answered yes everytime they were asked, Z answered no twice, etc).~Time points 2, 3, and 4 are dependent on patient response to Do you want more pain medication? Time 1 is 30 min post-baseline. For those who answer no, Time 2 is 30 minutes later (at 1 hour), and for yes, Time 2 is 30 minutes after additional pain medication is given. This pattern follows for Time 3 and 4, with a total study time of 4 hours"|4 hours||||Participants|||Count of Participants
2627205|NCT01892657|Primary|Area of Erythema and Elevated Responses of Skin to Product|Subjects were patched 9 times at 48 hour to 72 hour intervals and graded for erythema and elevated responses (edema, papules, vesicles, bullae) on a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). 12 to 24 hours after the last patch application, a challenge patch was applied at the same site and a challenge patch was applied to an alternate site. Both were graded for the same criteria at 48 hours and at 96 hours. A total of 11 patches were applied to each subject. All patches were removed after 48 hours.|3 consecutive weeks||||participants|||Number
2627206|NCT01892540|Primary|Sensitivity of PET/CT and PET/MRI (Cohort III)|"McNemar's test or a generalized estimating equations logistic regression model with patient as the cluster used to compare sensitivity rates of the new technology versus current technology (MRI alone), restricting analysis to true negative lesions. Utilizing 3 different combinations of scan parameters to determine which combination has the highest sensitivity.~Combinations include:~Single parameter: DCE-MRI Two Parameter A: DCE-MRI and DWI ADC Two Parameter B: DCE-MRI and FDG-PET Three Parameter: DCE-MRI, DWI ADC, FDG-PET"|1 yr from study start|Participants in cohort 3 that completed scans.|||percent sensitivity||Full Range|Mean
2627207|NCT01892540|Primary|Comparison of Specificity Rates of Fused FDG-PET/MRI (Cohort III)|"McNemar's test or a generalized estimating equations logistic regression model with patient as the cluster used to compare specificity rates of the new technology versus current technology (MRI alone), restricting analysis to true negative lesions. Utilizing 3 different combinations of scan parameters to determine which combination has the highest specificity. Single parameter: DCE-MRI is the gold standard to which the two parameter and three parameter rows are compared.~Combinations include:~Single parameter: DCE-MRI Two Parameter A: DCE-MRI and DWI ADC Two Parameter B: DCE-MRI and FDG-PET Three Parameter: DCE-MRI, DWI ADC, FDG-PET"|1 yr from study start|Participants in cohort 3 that completed scans.|||percent of specificity||Full Range|Mean
2627208|NCT01892540|Primary|Attenuation Correction for PET/CT, Assessed Using SUVs (Cohorts I & II)|Uptake and attenuation correction of PET/MRI and PET/CT will be examined by comparing SUVs of the two methods. The proportions of subjects with SUV of the PET/MR within 5%, 10%, and 20% of the SUV from PET/CT will be estimated with exact 95% confidence intervals.|1 yr from study start|No data available - SUV data do not exist for Cohort I and cohort II was never conducted.||||||
2627209|NCT01892540|Primary|Attenuation Correction for PET/MRI, Assessed Using Standard Uptake Values (SUVs) (Cohorts I & II)|Uptake and attenuation correction of PET/MRI and PET/CT will be examined by comparing SUVs of the two methods. The proportions of subjects with SUV of the PET/MR within 5%, 10%, and 20% of the SUV from PET/CT will be estimated with exact 95% confidence intervals.|1 yr from study start|No data available - SUV data do not exist for Cohort I and cohort II was never conducted.||||||
2627210|NCT01892436|Secondary|Percentage of Subjects Achieving Disease Remission (DAS28<2.6)|Percentage of subjects achieving disease remission (DAS28<2.6). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission|weeks 116, 128, 140, 156, 180, 208, 232 and 260||||percentage of participants||95% Confidence Interval|Number
2627211|NCT01892436|Secondary|Percentage of Subjects Achieving Low Disease Activity|Percentage of subjects achieving low disease activity (DAS28 ≤ 3.2). The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission|weeks 116, 128, 140, 156, 180, 208, 232 and 260|Extension FAS|||percentage of participants||95% Confidence Interval|Number
2627212|NCT01892436|Secondary|Change From Baseline in Disease Activity Score-CRP (DAS28)|"Changes in DAS28 (utilizing hsCRP) from baseline up to Month 60. The DAS28 is a measure of disease activity in PsA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. This measure represents change in scores - not the actual scores.~DAS28 is a combined measure of disease activity based on the following formula:~DAS28-CRP = 0.56*TJC28^0.5 + 0.28*SJC28^0.5 + 0.36*ln(CRP+1) + 0.014*PGA + 0.96 The greater the score is, the more the disease activity exists. Remission is defined as DAS28-CRP < 2.6 Low disease activity is defined as DAS28-CRP < 3.2 The minimum value can be 0.96 (not applicable in our study due to the inclusion/exclusion criteria regarding tender, swollen joints). There is no maximum expected value for this score"|weeks 116, 128, 140, 156, 180, 208, 232 and 260|Extension FAS|||change in scores||Standard Deviation|Mean
2627213|NCT01892436|Secondary|Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)|Percentage of subjects with improvements from baseline in HAQ-DI meeting or exceeding minimal clinically important difference (MCID=0.3). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities.|weeks 116, 128, 140, 156, 180, 208, 232 and 260|Extension FAS|||percentage of participants||95% Confidence Interval|Number
2627238|NCT01892267|Secondary|Short-term Complications|Short-term complications will include stomal (Infection, erythema, bleeding, pain and secretion, etc) and tube (Clotting, dislocation, defect, aspiration, etc) complications detected in the first week.|One week||||participants|||Number
2672096|NCT01472549|Secondary|Number of Participants With Skin Irritation||30 days||||Participants|||Count of Participants
2627214|NCT01892436|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)|"Changes from baseline in score of the disability assessment component of the HAQ (Health Assessment Questionnaire - Disability Index). The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities.~Health Assessment Questionnaire - Disability Index (HAQ-DI) ranges from 0 (no disability) to 3 (very severe disability)"|weeks 116, 128, 140, 156, 180, 208, 232 and 260|Extension FAS|||change in scores||Standard Deviation|Mean
2627215|NCT01892436|Primary|Proportion of Subjects Who Reached ACR70|"Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR70 criteria if he/she has at least 70% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:- Patient's assessment of PsA pain~Patient's global assessment of disease activity~Physician's global assessment of disease activity~Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score)~Acute phase reactant (hsCRP or ESR)"|weeks 116, 128, 140, 156, 180, 208, 232 and 260|Extension FAS|||percentage of participants||95% Confidence Interval|Number
2627216|NCT01892436|Primary|Proportion of Subjects Who Reached ACR50|"Proportion of subjects that have a positive clinical response to treatment (individual improvement) in disease activity according to ACR50 criteria if he/she has at least 50% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:~Patient's assessment of PsA pain~Patient's global assessment of disease activity~Physician's global assessment of disease activity~Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score)~Acute phase reactant (hsCRP or ESR)"|weeks 116, 128, 140, 156, 180, 208, 232 and 260|Extension FAS|||percentage of participants||95% Confidence Interval|Number
2627217|NCT01892436|Primary|Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20|"Proportion of subjects with a positive clinical response to treatment (individual improvement) in disease activity according to ACR20 criteria if he/she has at least 20% improvement in 1. Tender 68-joint count 2. Swollen 66-joint count and 3. At least 3 of the following 5 measures:~Patient's assessment of Psoriatic Arthritis (PsA) pain~Patient's global assessment of disease activity~Physician's global assessment of disease activity~Subject self-assessed disability (Health-Assessment Questionnaire [HAQ-DI] score)~Acute phase reactant (hsCRP or ESR)"|weeks 116, 128, 140, 156, 180, 208, 232 and 260|Extension Full Analysis Set (extension FAS) is comprised all patients enrolled in the extension study who had at least one post baseline assessment of efficacy during the extension period. Patients were analyzed according to the treatment they were assigned.|||percentage of participants||95% Confidence Interval|Number
2627218|NCT01892345|Secondary|Change From Baseline In EuroQoL EQ-5D Index Score At End Of Study|The EuroQoL EQ-5D is a generic, standardized, self-administered instrument that provides a simple, descriptive profile and a single index value for health status. Index scores range from less than 0 to 1, with higher scores representing a better health status.|Baseline, Up To 211 Weeks (End of Study)|Full Analysis Set (FAS): all participants who were randomized to treatment and who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2627219|NCT01892345|Secondary|Change From Baseline In European Quality Of Life (EuroQoL) Health 5-Dimension Questionnaire (EQ-5D) Visual Analogue Scale At End Of Study|"The EuroQoL EQ-5D is a generic, standardized, self-administered instrument that provides a simple, descriptive profile and a single index value for health status. Assessments were made using the EQ-5D Visual Analogue Scale, which captures the self-rating of current health status using a visual thermometer with the endpoints of 100 (best imaginable health state) at the top and zero (worst imaginable health state) at the bottom. An increase in score indicates improvement."|Baseline, Up To 211 Weeks (End of Study)|Full Analysis Set (FAS): all participants who were randomized to treatment and who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2627220|NCT01892345|Secondary|Change From Baseline In Hauser Ambulation Index (HAI) Score At End of Study|The HAI evaluates gait and was used to assess the time and effort used by the participant to walk 25 feet (8 meters). The scale ranges from 0 to 9, with 0 being the best score (asymptomatic; fully ambulatory with no assistance) and 9 being the worst (restricted to wheel chair; unable to transfer self independently). A decrease in score indicates improvement.|Baseline, Up To 211 Weeks (End of Study)|Full Analysis Set (FAS): all participants who were randomized to treatment and who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2627221|NCT01892345|Secondary|Change From Baseline In Modified Rankin Scale (mRS) Score At End Of Study|Disease-related disability was measured by the mRS score. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered from a neurological disability. The scale ranges from 0 (no disability) to 6 (death) in whole-point increments. A decrease in score indicates improvement.|Baseline, Up To 211 Weeks (End of Study)|Full Analysis Set (FAS): all participants who were randomized to treatment and who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2627222|NCT01892345|Secondary|Change From Baseline In EDSS At End Of Study|Disease-related disability was measured by the EDSS. The EDSS is an ordinal clinical rating scale that ranges from 0 (normal neurologic examination) to 10 (death) in half-point increments. A decrease in score indicates improvement.|Baseline, Up To 211 Weeks (End of Study)|Full Analysis Set (FAS): all participants who were randomized to treatment and who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2627223|NCT01892345|Secondary|Adjudicated On-trial Annualized Relapse Rate (ARR)|The adjudicated On-trial ARR was computed as the total number of relapses divided by the total number of patient years in the study period. A central independent committee was used to adjudicate all On-trial Relapses as determined by the treating physician. Results reported as adjusted adjudicated On-trial ARR based on a Poisson regression adjusted for randomization strata and historical ARR in 24 months prior to Screening.|Baseline, Up To 211 Weeks (End of Study)|Full Analysis Set (FAS): all participants who were randomized to treatment and who received at least 1 dose of study drug.|||relapses/years on study||95% Confidence Interval|Number
2627240|NCT01892267|Secondary|Difficulty of the Procedure|"Scored by the endoscopist on a 10-point Visual Analogue Scale with zero being without difficulty and 10 being maximum difficulty.~The lower the score, the better the outcome."|Inra-procedural||||units on a scale||Standard Deviation|Mean
2637574|NCT01780922|Primary|Glutathione Peroxidase (GPx) Activity in Red Blood Cells||0, 2, 4, 8, 24 h||||mU/mg HgB||Standard Error|Mean
2627225|NCT01892306|Other Pre-specified|Association Between Change on Depression (HAM-D) and Baseline Resting State Functional Connectivity of Anterior Insula and Ventrolateral Prefrontal Cortex|Resting state functional magnetic resonance imaging (rsfMRI) data (non-task, eyes opened) was acquired to investigate anterior insula and ventrolateral prefrontal cortex functional connectivity as a predictor of change on depression (HAM-D). See primary outcome description of HAM-D.|Six Months|Participating in the fMRI portion of the study was optional. A total of 15 participants consented to participate in fMRI portion (7 TAU+UP, 8 TAU). Data from all 15 subjects were analyzed.|||beta coefficient||Standard Error|Mean
2627226|NCT01892306|Secondary|Association Between Anxiety Symptom Change (HAM-A) and Neuroticism (NEO Five-Factor Inventory- NEO-FFI-N)|Neuroticism was assessed using the NEO Five Factor Inventory (NEO-FFI-N) which is a subscale of the NEO-FFI, a 60-item Likert-type scale (1-5) calculated by summing scores for each subscale. Only the 15-item Neuroticism subscale is included in this study. See Baseline Characteristics for baseline NEO-FFI-N. See Primary Outcome Measure for description of HAM-A.|6 months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.|||beta coefficients||Standard Error|Mean
2627227|NCT01892306|Secondary|Association Between Anxiety Symptom Change (HAM-A) and Anxiety Sensitivity (Anxiety Sensitivity Index-ASI)|Anxiety sensitivity, were assessed using the Anxiety Sensitivity Index, or ASI, a 16-item Likert-type scale (0-4) calculated by summing scores across items. See Baseline Characteristics for baseline ASI scores. See Primary Outcome Measures for a description of HAM-A.|6 months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.|||beta coefficients||Standard Error|Mean
2627228|NCT01892306|Secondary|Association Between Anxiety Symptom Change (HAM-A) and Reaction to Emotions (Affective Control Scale-ACS)|Reactions to emotions, were assessed using the Affective Control Scale, or ACS, a 42-item Likert-type scale (1-7) calculated by averaging scores across all items. See Baseline Characteristics for baseline ACS score. See Primary Outcome Measure for description of HAM-A.|6 months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.|||beta coefficients||Standard Error|Mean
2627229|NCT01892306|Secondary|Association Between Anxiety Symptom Change (HAM-A) and Difficulties in Emotion Regulation Scale (DERS)|Emotion regulation skills were assessed using a measure of emotion regulation (Difficulties in Emotion Regulation Scale- DERS), a 36-item Likert-type scale (1-6) calculated by averaging scores across all items. See Baseline Characteristics for baseline DERS score. See Primary Outcome Measure for a description of HAM-A.|Six Months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.|||beta coefficients||Standard Error|Mean
2627230|NCT01892306|Secondary|Treatment Acceptability as Measured by Client Satisfaction Questionnaire (CSQ)|The Client Satisfaction Questionnaire (CSQ) is an 8-item scale that assesses perceptions of acceptability and quality of outpatient treatment. Ratings are made on a 1 (poor) to 4 (excellent) scale for each item and then summed for a total score, with a minimum score of 8 and a maximum score of 32. Higher scores indicate greater satisfaction with treatment.|Six months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.|||Units on scale||Standard Deviation|Mean
2627231|NCT01892306|Primary|Reductions Over Time in Depression Symptoms as Measured by Hamilton Depression Rating Scale (HAM-D)|The Hamilton Depression Rating Scale (HAM-D) is a well-validated clinician administered rating of depression-related symptoms. Scores are calculated by summing scores across all 17-items, with a minimum score of 0 and a maximum score of 54. Higher scores indicate greater impairment.|Six months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.|||Units on scale||Standard Deviation|Mean
2627232|NCT01892306|Primary|Reductions Over Time in Anxiety Symptoms as Measured by Hamilton Anxiety Rating Scale|The Hamilton Anxiety Rating Scale (HAM-A) is a well-validated clinician administered rating of anxiety-related symptoms. Ratings are made on a 0 (no symptoms) to 4 (most severe in frequency/duration/interference/distress) for each item (14 items), with a minimum score of 0 and a maximum score of 56 calculated by summing scores of all 14 items. Higher scores indicate greater impairment.|Six months|ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis.|||Units on scale||Standard Deviation|Mean
2627233|NCT01892293|Secondary|Peak Persistence of Modified T-cells in the Peripheral Blood|Measurement of NY-ESO-1ᶜ²⁵⁹T cells in blood (copies of WPRE per µg of genomic PBMC DNA)|Days 1, 3, 5, 8, 15, 22, 29, 43, 101, 130 181, every 3 months thereafter|Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T with persistence data|||copies per μg of DNA||Full Range|Mean
2627234|NCT01892293|Secondary|Evaluate the Direct Anti-tumor Activity of NY-ESO-1ᶜ²⁵⁹T|Number of participants with response post-infusion as assessed by international uniform response criteria|180 days|Participants who received NY-ESO-1ᶜ²⁵⁹T|||Participants|||Count of Participants
2627235|NCT01892293|Primary|Adverse Events Related to Study Treatment|Number of Participants with NCI CTCAE Version 4.0 Adverse Events related to study treatment greater than or equal to Grade 3|Up to 12 months|Participants who received NY-ESO-1ᶜ²⁵⁹T|||Participants|||Count of Participants
2627236|NCT01892267|Secondary|Direct Cost|Cost will be determined according to Medicare reimbursement of billed CPT codes. The cost of all related follow-up procedures will be included (e.g. cost of standard PEGJ in case of failed Self-propelled PEGJ feeding tube, cost of managing complications, cost of re-intervention in case of tube dysfunction, etc)|2 years|Study terminated prematurely, so that the appropriate follow-up data was not collected.||||||
2627247|NCT01892189|Secondary|Percentage of Participants Who Meet the TGRD Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose|The percentage of participants who meet markedly abnormal criteria designated by TGRD measured throughout study.|Baseline up to 14 days after last dose of study drug (Day 32)|Safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2627248|NCT01892189|Secondary|Percentage of Participants Who Meet the TGRD Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose|The percentage of participants who meet markedly abnormal criteria designated by TGRD. Vital signs included oral temperature, respiration, blood pressure and pulse (beats per minute).|Baseline up to 14 days after last dose of study drug (Day 32)|Safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2627249|NCT01892189|Secondary|Percentage of Participants Who Meet the Takeda Global Research and Development Center, Inc. (TGRD) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose|The percentage of participants with any markedly abnormal standard safety laboratory values collected throughout study.|Baseline up to 14 days after last dose of study drug (Day 32)|Safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2627250|NCT01892189|Secondary|Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)||Baseline up to 14 days after last dose of study drug (Day 32)|Safety analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2627251|NCT01892189|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 M-I||Day 1: Pre-dose and at multiple time points (up to 24 hours) post-dose|The PK analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg.|||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
2627252|NCT01892189|Secondary|Tmax: Time to Reach Cmax for TAK-063 and TAK-063 M-I||Day 1: pre-dose and at multiple time points (up to 24 hours) postdose|The PK analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg.|||hours||Full Range|Median
2627253|NCT01892189|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite (M-I)||Day 1: pre-dose and at multiple time points (up to 24 hours) postdose|The pharmacokinetic (PK) analysis set included all participants in the safety set and with at least 1 measurable plasma concentration. PK analysis set did not include 2 participants treated with 300 mg.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2627254|NCT01892189|Primary|Ketamine-Induced Brain Activity in Regions of Interest During Resting State|Ketamine model was used to enhance the sensitivity to detect an effect of phosphodiesterase 10a (PDE10a) inhibition by TAK-063 by ketamine using neuroimaging battery tests. Ketamine induced robust blood oxygen level-dependent(BOLD) functional magnetic resonance imaging(fMRI) response while maintaining minimal accompanying psychotomimetic symptoms. The regions of interest include:left anterior cingulate cortex,right anterior cingulate cortex,left posterior cingulate cortex,right posterior cingulate cortex,left striatum,right striatum,left amygdala,right amygdala,left substantia nigra,right substantia nigra,left thalamus,right thalamus,left ventrolateral prefrontal cortex,right ventrolateral prefrontal cortex,left dorsolateral prefrontal cortex,right dorsolateral prefrontal cortex,left hippocampus,right hippocampus,left subgenual cingulate/Ba25,right subgenual cingulate/Ba25,left paracingulate gyrus/Ba32, and right paracingulate gyrus/Ba32.|Day 1: 4 hours post TAK-063 dose or placebo|The pharmacodynamic (PD) analysis set included all participants in the safety set and with at least 1 valid PD assessment. PD analysis set did not include 2 participants treated with TAK-063 300 mg.|||percent signal change in brain activity||Standard Deviation|Mean
2627255|NCT01892163|Secondary|Proportion of Patients With Ocular and Systemic Serious Adverse Events||12 months||||participants|||Number
2627256|NCT01892163|Secondary|Difference Between Arms in Change in Central Subfield Thickness.|Central subfield thickness is defined as the average thickness in the central 1mm diameter circle of the ETDRS grid and is measured in microns|Baseline and 12 months|Few patients in both groups developed cataract. Due to the dense cataract, it was not possible to obtain the macular scans. Hence the discrepancy between the population who completed the study and the number for whom the OCT was obtained at exit visit.|||microns||Standard Deviation|Mean
2627257|NCT01892163|Secondary|Difference Between Arms in Change From Baseline Composite Scores of the National Eye Institute Visual Function Questionnaire (VFQ-25).|"NEI VFQ 25 is a questionnaire intended to measure visual function and quality of life. It has 25 questions. The original response of each item are coded as per the NEI VFQ scoring system ranging from 0 (lowest) to 100 (highest).~Composite score = (Score for each item with a non-missing answer) / Total number of items with non-missing answers 100 = Best, 0 = Worst possible score"|Baseline and 12 months|Though 48 patients completed the trial in the PRN arm, one patient did not complete the questionnaire completely, making it invalid for analysis. Hence the PRN arm number for this outcome was 47|||units on a scale||Standard Deviation|Mean
2627258|NCT01892163|Primary|The Difference Between Arms in the Change From Baseline in Best Corrected Visual Acuity at 12 Months||Baseline and 12 months|Intention to treat analysis (available case)|||ETDRS letters||Standard Deviation|Mean
2627259|NCT01892020|Secondary|Incidence of AEs (Adverse Event)|Treatment emergent AE (TEAE) is defined as an event that has onset date on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment.|During 4 weeks of treatment in each treatment sequence|Safety analysis set included all subjects receiving at least one dose of investigational products.|||Events/100 years of patient exposure|||Number
2627260|NCT01892020|Secondary|Incidence of Hypoglycemic Episodes|Treatment Emergent Hypoglycemic Episode refers to those the onset of the episode is on or after the first day of exposure to randomized treatment and no later than the last day of randomized treatment. Results are presented by American Diabetes Association classification of hypoglycemia.|During 4 weeks of treatment in each treatment sequence|Safety analysis set included all subjects receiving at least one dose of investigational products.|||events per patient per year|||Number
2627394|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Day 6|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
2627261|NCT01892020|Secondary|The Mean 2-hour PPG Increments of the 3 Main Meals in 8-point SMPG Profile|Mean post prandial PG increment over all meals was derived as the mean of all available meal increments.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Four (4) subjects in BIAsp 50 group and 9 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements.|||mmol/L||Standard Error|Least Squares Mean
2627262|NCT01892020|Secondary|2-hour PPG Increments Over Each of the 3 Main Meals in 8-point SMPG (Self-measured Plasma Glucose) Profile|PPG increments over each of the 3 main meals were derived from the 8-point SMPG profile as the difference between PG values available 120 minutes after meal and before meal.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Subjects were excluded from analysis due to lack of post-randomization measurements. See table.|||mmol/L||Standard Error|Least Squares Mean
2627263|NCT01892020|Secondary|-IAUC (Incremental Area Under the Curve) for PPG (0-2 Hours) Following a Standard Meal Test|AUC for plasma glucose was calculated by the trapezoidal method using 30-min sampling time points, and IAUC for PPG (0-2h) data was analyzed using a normal linear mixed model.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Three (3) subjects in BIAsp 50 group and 9 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements.|||min*mmol/L||Standard Deviation|Mean
2627264|NCT01892020|Secondary|-1-hour PPG Increment Following a Standard Meal Test|The 1-h PPG increment is the difference between the plasma glucose (PG) value at 60 minutes after standard meal test and the fasting PG value.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Three (3) subjects in BIAsp 50 group and 8 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements.|||mmol/L||Standard Deviation|Mean
2627265|NCT01892020|Primary|2-hour PPG (Postprandial Plasma Glucose) Increment Following a Standard Meal Test|The 2-hour PPG increment is the difference between the plasma glucose (PG) value at 120 minutes after standard meal test and the fasting PG value.|After 4 weeks of treatment in each treatment sequence|Of the 161 randomized subjects, 155 subjects received BIAsp 50 and 158 subjects received BHI 50 (152 subjects received both, 3 subjects only received BIAsp 50 and 6 subjects only received BHI 50). Three (3) subjects in BIAsp 50 group and 9 subjects in BHI 50 group did not contribute to the analysis due to lack of post-randomization measurements.|||mmol/L||Standard Deviation|Mean
2627266|NCT01891994|Primary|Number of Participants With Drug Response as Defined by Clinically-signficant Hematologic Improvements|Defined as unilineage or multilineage recovery by 1 or more of the following: 1) platelet response (increase to 20 × 103/μL above baseline or stable platelet counts with transfusion independence for a minimum of 8 weeks in those who were transfusion dependent on entry into the protocol); (2) erythroid response (when pretreatment hemoglobin was <9 g/dL, defined as an increase in hemoglobin by 1.5 g/dL or, in transfused patients, a reduction in the units of packed red blood cell transfusions by an absolute number of at least 4 transfusions for 8 consecutive weeks, compared with the pretreatment transfusion number in the previous 8 weeks); and (3) neutrophil response (when pretreatment absolute neutrophil count [ANC] of <0.5 × 103/μL as at least a 100% increase in ANC, or an ANC increase >0.5 × 103/μL, and the toxicity profile as measured using Common Terminology Criteria for Adverse Events).|24 weeks|All subjects who received Eltrombopag were analyzed.|||Participants|||Count of Participants
2627267|NCT01891968|Primary|Overall Response (OR)|Primary outcome is overall response (OR) including hematologic improvement defined by International Working Group (IWG), complete remission, partial remission and marrow complete remission.|8 weeks||||Participants|||Count of Participants
2627268|NCT01891890|Other Pre-specified|Pediatric Inventory for Parents|"The Pediatric Inventory for Parents consists of 42 items involving communication, medical care, emotional disturbance, and change in role function. Parents respond to a list of difficult events (such as difficulty sleeping) that are often experienced by parents of children who are seriously ill. Parents indicated how frequently an event occurred by selecting 1=Never, 2=Rarely, 3=Sometimes, 4=Often, or 5=Very often. Raw score values range from 4 to 210 with higher scores indicating increased frequency of difficult events."|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some parents attended a study visit but did not complete the Pediatric Inventory for Parents.|||units on a scale||Standard Deviation|Mean
2627269|NCT01891890|Other Pre-specified|Parenting Stress Inventory Short Form (PSI-4-SF)|The Parenting Stress Inventory-4-Short Form is a 36 item questionnaire, completed by the parent/guardian, designed to evaluate parenting and family characteristics based upon child characteristics (behavioral and emotional problems), parent characteristics, and situational/demographic life stress. Respondents indicate the degree to which they agree with a variety of statements by selecting 1=strongly agree, 2=agree, 3=not sure, 4=disagree, or 5=strongly disagree. Raw scores range from 36 to 180 and higher scores are associated with higher parental stress.|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some parents attended a study visit but did not complete the PSI-4-SF.|||units on a scale||Standard Deviation|Mean
2627278|NCT01891890|Secondary|Child Behavior Checklist|The Child Behavior Checklist is a measure of specific behavioral and emotional problems are rated by the child's parent or guardian. The Child Behavior Checklist examines three domains (Social Functioning, Mood and Anxiety Symptoms, and Externalizing Symptoms) by assessing 118 problem items that describe specific behavioral and emotional problems. Respondents indicate how accurately the statements describe the child by selecting from options on a 3-point Likert-type scale (0=Not True, 1= Somewhat or Sometimes True, or 2=Very True or Often True). Total raw scores are converted to t-scores with a mean of 50 and standard deviation of 10. A t-score of 67 or greater is considered to be in the clinical range for problematic behavior.|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the Child Behavior Checklist.|||t-scores||Standard Deviation|Mean
2627270|NCT01891890|Other Pre-specified|Pediatric Neuro-QOL Score|The Pediatric Neuro-QOL is a Quality of Life instrument developed in conjunction with NIH with a pediatric specific form utilized in this protocol. Pediatric Neuro-QOL assesses the domains of Anger, Anxiety, Cognition, Depression, Fatigue, Pain, Social Relations, and Stigma. Each domain has 8 to 10 items and respondents indicate how often they experienced feelings and circumstances related to each domain on a scale of 1 to 5 (such as 1=never, 2=almost never, 3=sometimes, 4=often, 5=almost always). Higher values indicate increased difficulty for most of the scales but this pattern is reversed for two of the domains. Raw scores are rescaled to standardized scores with a mean of 50 and a standard deviation of 10. Higher values for the standardized scores indicate more problematic characteristics while scores below 50 indicate that the child is experiencing less trouble in the domains measured by the Pediatric Neuro-QOL.|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. This survey was completed by children aged 10 and older.|||t-scores||Standard Deviation|Mean
2627271|NCT01891890|Other Pre-specified|Affective Reactivity Scale|"The Affective Reactivity Scale is a 7-item survey completed by the child participants which asks questions concerning their level of agreement with statements about anger and irritability. Respondents select between not true (scored as 0), somewhat true (scored as 1), and certainly true (scored as 2). Total scores range from 0 to 14 with higher values indicating increased feelings of annoyance and anger."|Baseline, Month 3, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the Affective Reactivity Scale.|||units on a scale||Standard Deviation|Mean
2627272|NCT01891890|Other Pre-specified|Youth Self Report||6 months|As this study was terminated early, the scoring algorithm was not programmed for this outcome measure.||||||
2627273|NCT01891890|Other Pre-specified|The Number of Participants With a Positive Response on the Columbia-Suicide Severity Rating Scale (C-SSRS)|"Suicidal behaviors and suicidal ideation were assessed through an interview using the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS guides interviewers to ask a series of simple questions in order to identify people at risk for suicide, as well as the severity and urgency of suicidal thoughts and behaviors. The Children's Baseline/Screening C-SSRS was used at the initial study visit while the Children's Since Last Visit C-SSRS was used for subsequent study visits. Any responses of yes to the C-SSRS questions are considered a positive response, indicating that the participant is experiencing thoughts of suicide or has exhibited suicidal behaviors."|Baseline, Month 3, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the C-SSRS.|||Participants|||Count of Participants
2627274|NCT01891890|Other Pre-specified|Grooved Pegboard|The Grooved Pegboard assesses fine motor speed and dexterity. The participant fits keyhole-shaped pegs into similarly shaped holes on a square board. The pegs, which have an edge along one side, must be rotated to match the holes before they can be inserted. The scores represent the number of seconds it took for the participant to correctly insert the pegs into the require number of grooves, using their dominant hand.|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the Grooved Pegboard task.|||Seconds||Standard Deviation|Mean
2627275|NCT01891890|Other Pre-specified|Symbol Digit Modalities Test|Symbol Digit Modalities Test (SDMT) is a test of graphomotor speed using numbers as the response rather than copying symbols, and is timed at 90 seconds. The SDMT is designed for people who are 8 years of age and older and detects brain dysfunction as well as measures function over time. Possible total scores range from 0 to 110; where 110 indicates that all values were entered within the 90 second limit. An increase between initial and retest scores indicates that the respondent is correctly matching numbers to symbols at a faster speed. The SDMT was administered at the Month 3 and Month 6 visits for this study.|Month 3, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Participants who were 8 years old or older were eligible to complete the Symbol Digit Modalities Test.|||number of correct responses||Standard Deviation|Mean
2627276|NCT01891890|Other Pre-specified|Story Memory|"Story Memory will be measured at baseline with the Children's Memory Scale (CMS) and then with the Wide Range Assessment of Memory and Learning-2 (WRAML-2) at the 6 month follow up visit. Two different tests are used to avoid practice effects in memory assessment associated with repeated assessments using the same stimulus material. The Story Memory sub-test of the CMS and the WRAML-2 Story Memory are measures of prose passage recall. Stories are read to the subject for recall, with different stories presented based upon participant age. Scores are converted to percentile ranks for both measurements of story memory. Possible scores can fall between the 1st and 99th percentile and higher values indicate better performance with story recall. Values between the 9th and 25 percentiles are considered low average, values between the 25th and 75th percentiles are average, while values between the 75th and 91st percentile are high average."|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the Story Memory measurement.|||percentiles||Standard Deviation|Mean
2627277|NCT01891890|Other Pre-specified|Wechsler Intelligence Scale for Children-IV Processing Speed|Coding and Symbol Search subtests from the Wechsler Intelligence Scale for Children (WISC)-IV are measures of processing speed and combine to form the Processing Speed Index. Processing speed refers to how quickly the child understands and responds to information. Coding presents children with a row of boxes containing a numeral in the top line and a symbol in the bottom line with the task of copying the symbol corresponding to each numeral as quickly as possible in 120 seconds. In Symbol Search, children are given rows of symbols and target symbols and are asked to mark whether or not the target symbols appear in each row as quickly as possible during 120 seconds. Composite scores compare the test-taker to peers with a mean score of 100 and a standard deviation of 15. Possible scores range from 40 to 160 with higher scores indicating increased processing speeds. Scores between 85 and 115 are considered average, with 2/3 of test takers falling between these values.|Baseline, Month 3, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the WISC-IV.|||units on a scale||Standard Deviation|Mean
2627395|NCT01890694|Secondary|Severity of Hepatic Encephalopathy|Change from baseline of Hepatic Encephalopathy|Day 4|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
2627279|NCT01891890|Primary|Conners' Continuous Performance Test II (CPT-II) Confidence Index|"The Conners' Continuous Performance Test II (CPT-II) is a measure of sustained attention. Letters are individually presented on a computer screen, and participants are instructed to press the space bar when they are presented with any letter except the letter X. For children younger than 6 years of age at enrollment, the Kiddie CPT will be used in which the child is instructed to press the space bar every time the ball appears on the screen. The outcome measure is a confidence index representing the probability that the respondent has a clinically relevant problem in sustained attention. Possible scores range from 0 to 100. Scores between 40 and 60 are considered inconclusive while scores above 60 indicate that the child exhibits inattentiveness."|Baseline, Month 6|The analysis includes participants who completed the assessment at the specified study visit. Some participants attended a study visit but did not complete the CPT-II.|||Confidence Index||Standard Deviation|Mean
2627280|NCT01891864|Secondary|Immunogenicity: Measurement of Rate of ADA Formations Against GP2015 Etanercept and Enbrel ® Etanercept|Immunogenicity was analyzed by the percentage of patients with positive anti-drug antibodies (ADA) to either GP2015 Etanercept or Enbrel ® up to Week 52.|Week 52|The analysis was performed on immunogenicity set consisting of patients who provided data for ADA assessment of etanercept at baseline visit.|||percentage patients with positive ADA|||Number
2627281|NCT01891864|Secondary|Injection Site Reactions|Percentage of patients with injection site reactions up to Week 52|Week52|The analysis was performed on safety set including all patients who took at least 1 dose of study treatment|||percentage of patients with ISRs|||Number
2627282|NCT01891864|Secondary|PASI 50, 75 and 90 Response Rates|Percentage of patients achieving Psoriasis Area and Severity Index (PASI) 50, PASI 75, and PASI 90 responses at Week 12. PASI 50 response: patients who achieved ≥ 50% improvement (reduction) in PASI score compared to baseline were defined as PASI 50 responders .PASI 90 response: patients who achieved ≥ 90% improvement (reduction) in PASI score compared to baseline were defined as PASI 90 responders .|Week12|The analysis of this secondary outcome measure was based on the per-protocol set (PPS) consisting of patients who completed study until 12 weeks without any major protocol deviation.|||percentage of patients|||Number
2627283|NCT01891864|Secondary|Percent Change From Baseline in PASI Score up to Week 12|The key secondary efficacy endpoint was the % change from baseline in PASI score up to Week 12. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity. Two approaches (longitudinal approach applying a Mixed Model Repeated Measures and Averaged Treatment Effect approach applying an ANCOVA model) were employed in order to calculate 2-sided 95% confidence intervals (CI) for the difference between the treatment groups.|12 weeks|The analysis was based on the per-protocol set (PPS) consisting of patients who completed study until 12 weeks without any major protocol deviation.|||percentage difference||Standard Error|Least Squares Mean
2627284|NCT01891864|Primary|PASI 75 Response Rate at Week 12 - GP2015 Etanercept vs. Enbrel ® Etanercept|The 95% CI for the Psoriasis Area and Severity Index (PASI) 75 response rate differences at Week12 between GP2015 Etanercept and Enbrel ® Etanercept. PASI 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretic maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.|Week 12|The analysis of the primary outcome measure was based on the per-protocol set (PPS) consisting of patients who completed study until 12 weeks without any major protocol deviation.|||% of patients achieving PASI75 response|||Number
2627285|NCT01891734|Secondary|Client Satisfaction Questionnaire (CSQ-8)|The 8-item Client Satisfaction Questionnaire (CSQ-8) is rated on an 8-32 scale. Higher scores represent greater satisfaction with the intervention.|6 weeks||||units on a scale||Standard Deviation|Mean
2627286|NCT01891734|Secondary|Short Form Health Survey-12-Veterans (SF-12 V) Mental Composite Score|The 12-item Short Form Health Survey-12-Veterans (SF-12 V) Mental Composite Score is rated on a 0-100 scale. Higher scores represent better mental health functioning.|6 weeks, 12 weeks|These data include all participants who completed the 6-week follow-up assessment. Two participants from the PST-MF group did not complete the 6-week follow-up.|||units on a scale||Standard Deviation|Mean
2627287|NCT01891734|Primary|Depression Anxiety and Stress Scale (DASS)|The 7-item depression subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse depression symptoms. The 7-item anxiety subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse anxiety symptoms. The 7-item stress subscale on the Depression Anxiety and Stress Scale (DASS) is measured on a 0-42 scale. Higher scores represent worse stress symptoms.|6 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2627288|NCT01891721|Secondary|Functional Capacity|The University of California San Diego (UCSD) Performance-based Skills Assessment (UPSA) was used to assess functional capacity. The UPSA total score served as a secondary functional outcome measure. Minimum and maximum values are 40 and 100. Higher scores mean a better outcome.|Within one week of training completion||||score on a scale||Standard Deviation|Mean
2627289|NCT01891721|Secondary|Electroencephalography (EEG)|A Mismatch Negativity (MMN) Paradigm was used to assess basic auditory processing. MMN amplitude was measured as the mean voltage in the 145-200 ms latency range at pooled frontocentral electodes. Minimum and maximum values are -8 and +2 microvolts. More negative scores mean a better outcome.|After 6 weeks of training and within one week of training completion||||units on a scale||Standard Deviation|Mean
2627290|NCT01891721|Primary|Neurocognition|The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) was used to assess basic cognition. It includes tests representing 6 separable cognitive domains. The MCCB composite score (average of 6 domain t-scores) served as the primary cognitive outcome measure. Minimum and maximum values are 20 and 68. Higher scores mean a better outcome.|Within one week of training completion||||score on a scale||Standard Deviation|Mean
2627291|NCT01891669|Secondary|Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax)||Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.|All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|||hour||Full Range|Median
2627292|NCT01891669|Secondary|Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax)||Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.|All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|||hour||Full Range|Median
2627293|NCT01891669|Secondary|Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax)||Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.|All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.|||hour||Full Range|Median
2627294|NCT01891669|Secondary|Overall Survival|Overall survival was defined as the time from initial dose until death from any cause, and was measured in the intent-to-treat population.|Baseline to death|All enrolled participants|||pariticpants|||Number
2627295|NCT01891669|Secondary|Objective Response|Number of particpants with objective response: confirmed CR or confirmed PR according to RECIST. CR was defined as the disappearance of all target lesions. A PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors had to have been confirmed by repeat studies that were performed ≥ 4 weeks after the criteria for response were first met.|Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.|Participants who had received at least one dose of study medication and had a baseline tumor assessment|||pariticpants|||Number
2627296|NCT01891669|Secondary|Number of Participants With Best Overall Response (BOR)|Number of participants with best overall response. Complete response (CR)=disappearance of all target lesions. Partial Response (PR)>=30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD) >=20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of >=1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.|Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.|Participants who had received at least one dose of study medication and had a baseline tumor assessment|||pariticpants|||Number
2627297|NCT01891669|Secondary|Number of Participants With Positive Anti-PF-06263507 Antibody|The number of participants with positive anti-PF-06263507 antibody.|Pre-dose Day 1, Cycle 1 Day 15, Day 1 of every Cycle, up to 21 days after the last dose of study medication|All enrolled participants who received at least one dose of study medication.|||Participants|||Number
2627298|NCT01891669|Secondary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria|Criteria for potentially clinically important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of <90 millimeters of mercury (mm Hg) or change in sitting SBP of >=30 mm Hg, sitting diastolic blood pressure (DBP) of <50 mm Hg or change in sitting DBP of >=20 mm Hg, sitting pulse rate of <40 or >120 beats per minute (bpm).|Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, end of treatment, and follow-up.|All enrolled participants who received at least one dose of study medication.|||Participants|||Number
2627299|NCT01891669|Secondary|Number of Participants With Abnormalities in Urine Protein in All Cycles.|Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 abnormalities in urine protein.|Baseline, Day 15 for Cycle 1, Day 1 for Cycle 2 and subsequent cycles, and end of treatment|All enrolled participants who received at least one dose of study medication.|||Participants|||Number
2627300|NCT01891669|Secondary|Number of Participants With Chemistry Test Abnormalities in All Cycles.|Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry tests abnormalities.|Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment|All enrolled participants who received at least one dose of study medication.|||Participants|||Number
2627301|NCT01891669|Secondary|Number of Participants With Hematological Test Abnormalities in All Cycles.|Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities.|Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment|All enrolled participants who received at least one dose of study medication.|||Participants|||Number
2627302|NCT01891669|Secondary|Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.|Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.|All enrolled participants who received at least one dose of study medication.|||participants|||Number
2627303|NCT01891669|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.|Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.|All enrolled participants who received at least one dose of study medication.|||participants|||Number
2627330|NCT01890759|Secondary|Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titer ratios were assessed in the Per Protocol Analysis Set.|||Titer ratios||95% Confidence Interval|Geometric Mean
2627304|NCT01891669|Primary|Number of Participants With Dose-limiting Toxicities (DLT)|DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (21 days) which were attributable to PF-06263507: 1) Grade 4 neutropenia lasting >7 days, 2) Febrile neutropenia, 3) Grade >=3 neutropenia with infection, 4) Any grade thrombocytopenia associated with clinically significant or life-threatening bleeding, 4) Grade 4 thrombocytopenia, 5) Any grade >=3 non-hematologic toxicities, 6) A positive cardiac troponin I result, 7) Persisting non-hematologic toxicities resulted in more than 2 weeks delay in receiving the next scheduled cycle. Severity of AEs was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Baseline up to Cycle 2 Day 1 (22 days)|All enrolled participants who received at least one dose of study medication.|||Participants|||Number
2627305|NCT01891357|Other Pre-specified|Proliferation and Apoptosis Genes|Proliferation Ki-67, Aurora A Kinase (STK15), survivin, Myb-related protein B (MYBL2),Cyclin B1 and apoptosis genes Bcl2, Epidermal Growth Factor-like 2 (SCUBE2), cleaved caspase C3 will be assessed in the samples from diagnostic and sequential biopsy.|One week before and after three weeks of treatment|Data were not collected and the outcome cannot be reported||||||
2627306|NCT01891357|Secondary|Overall Survival (OS)||5-year survival|Data were not collected and the outcome cannot be reported||||||
2627307|NCT01891357|Secondary|Event Free Survival (EFS)||5-year survival|Data were not collected and the outcome cannot be reported||||||
2627308|NCT01891357|Primary|Pathological Complete Response (pCR)|pCR was defined at the time of surgery and measured by size of residual tumor, proportion of vital cells within invasive carcinoma, number of positive lymph nodes (ypN) and size of the largest lymph node metastasis and ductal carcinoma in situ (ypT). pCR is defined as ypT0/is, ypN0. Further exploratory pCR definitions were ypT0, ypN0 (total pCR) and ypT0/is (near pCR).|Average of 16 weeks|Measurement of pCR: at time of surgery, measured by size of residual tumor, proportion of vital cells per invasive carcinoma, number of positive lymph nodes (ypN), size of largest lymph node metastasis, ductal carcinoma in situ (ypT). Definition of pCR: ypT0/is, ypN0. Exploratory pCR definition: ypT0, ypN0 (total pCR), ypT0/is (near pCR).|||Participants|||Count of Participants
2627309|NCT01891331|Primary|Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population|"For this trial, therapeutic cure was defined as mycological AND clinical cure. Mycological cure was defined as a negative fungal culture for Candida species. Clinical cure was defined as all of the following:~complete resolution of signs and symptoms pertaining to vulvovaginal candidiasis;~any new sign or symptom observed at 28 days determined by investigator to not be related to vulvovaginal candidiasis;~no use of any other antifungal drug therapy for treatment of vulvovaginal irritation and/or pruritus by subject."|4 weeks||||Participants|||Count of Participants
2627310|NCT01891305|Primary|Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population|For this trial, therapeutic cure was defined as clinical AND mycological cure. Clinical cure was defined as the absence of signs and symptoms of clinical disease. Mycological cure was defined as a negative KOH test and a negative fungal culture.|6 weeks||||Participants|||Count of Participants
2627311|NCT01890967|Secondary|Number of Participants With an Injection Site Reaction||Baseline through Week 24|All randomized participants who received at least one dose of study treatment and had evaluable data.|||Participants|||Number
2627312|NCT01890967|Secondary|Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady-State (AUC,ss) for LY3015014||Week 12-16 (Q4W) - Predose, Week 8-16 (Q8W) - Predose|All randomly assigned participants who received at least one dose of the study medication and had evaluable data.|||μg∙hr/mL||Geometric Coefficient of Variation|Geometric Mean
2627313|NCT01890967|Secondary|Percentage Change From Baseline in Free Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels|LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.|Baseline, Week 16|mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.|||Percentage change||Standard Error|Least Squares Mean
2627314|NCT01890967|Secondary|Percentage Change From Baseline in Total Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels|LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.|Baseline, Week 16|mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.|||Percentage change||Standard Error|Least Squares Mean
2627315|NCT01890967|Secondary|Number of Participants Who Develop Treatment Emergent Anti-LY3015014 Antibodies||Baseline through Week 24|All randomized participants who received at least one dose of study treatment and had evaluable data.|||Participants|||Number
2627316|NCT01890967|Secondary|Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)|LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.|Baseline, Week 16|mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.|||Percentage change||Standard Error|Least Squares Mean
2627317|NCT01890967|Secondary|Percentage Change From Baseline in Lipoprotein(a) [Lp(a)]|Data was log-transformed for MMRM analysis, with change from baseline as the dependent variable, and baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included as independent variables. Percentage change from baseline in the original scale was then back-calculated from the log-transformed MMRM analysis.|Baseline, Week 16|mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.|||Percentage Change||Standard Error|Least Squares Mean
2627331|NCT01890759|Secondary|Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titer ratios were assessed in the Per Protocol Analysis Set.|||Titer ratios||95% Confidence Interval|Geometric Mean
2627318|NCT01890967|Secondary|Percentage Change From Baseline in Apolipoprotein A1 (Apo A1), Apolipoprotein B (Apo B)|LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.|Baseline, Week 16|mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.|||Percentage change||Standard Error|Least Squares Mean
2627319|NCT01890967|Secondary|Percentage Change From Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C|LS Mean was calculated using mixed model repeated measures (MMRM) analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.|Baseline, Week 16|mITT is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.|||Percentage change||Standard Error|Least Squares Mean
2627320|NCT01890967|Primary|Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)|Least square (LS) Means was calculated using analysis of covariance (ANCOVA) adjusted for disease classification, statin dose, baseline LDL-C measurement. Percent change from baseline response is the dependent variable.|Baseline, Week 16|Modified Intent to Treat (mITT) is defined as all patients in the ITT population who had at least one baseline measurement and one post-randomization measurement of the variable that is analyzed.|||Percentage change||Standard Error|Least Squares Mean
2627321|NCT01890954|Primary|Percent of Time Spent Near Normoglycemia|Percentage of time that blood glucose (BG) values (measured with both finger-stick and CGM) were near normoglycemia (70-180 mg/dL).|8 hours||||percentage time near normoglycemia||Standard Error|Mean
2627322|NCT01890915|Other Pre-specified|Sweat Rate|To determine the change in sweat rate using QSweat methodology (WR TestWorks) from 30 minutes at 79 degrees F compared to after up to 2 hours at 95 degrees F. Sweat collection capsules will be placed on the left lateral anterior shoulder, volar aspect of the distal forearm, proximal anterior thigh, and mid-lateral calf (dermatomes C5, T1, L3, L5) for measurement of sweat rate. Hypothesis: Persons with tetraplegia compared with AB will have less of a percent change in average sweat rate after heat exposure.|2 hours||||Percent change||Standard Deviation|Mean
2627323|NCT01890915|Secondary|Cognitive Performance - Stroop Interference T-Scores|To determine the change in cognitive performance as measured by the Stroop Color and Word Interference T-Scores, measured after 30 min at 79 degrees F and after up to 2 hours at 95 degrees F. Interference T-Scores are derived from the difference between the raw Color-Word score and the projected Color-Word score (which is, in turn, based on the raw scores obtained in the Word and Color portions of the Test). Lower scores indicate poorer performance, and a positive percent change in T-scores indicates improved performance. Hypothesis: Persons with tetraplegia compared with AB will have a greater change in cognitive performance from baseline (79 degrees) to warm exposure (95 degrees).|2 hours||||Percent change||Standard Deviation|Mean
2627324|NCT01890915|Primary|Core Body Temperature|To determine the change in core body temperature in the seated position from 79 degrees F for 30 minutes to 95 degrees F for up to 2 hours. Hypotheses: Persons with tetraplegia will have a greater increase in core body temperature than able-bodied (AB) control subjects. Core body temperature in AB persons will be maintained.|2 hours||||Percent Change||Standard Deviation|Mean
2627325|NCT01890785|Primary|Cmax for D-amphetamine|d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.|Up to 96 hours-post-dose|Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||ng/ml||Standard Deviation|Mean
2627326|NCT01890785|Primary|AUC for D-amphetamine|d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.|Up to 96 hours post-dose|Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||ng*h/ml||Standard Deviation|Mean
2627327|NCT01890785|Primary|Maximum Plasma Concentration (Cmax) for Lisdexamfetamine Dimesylate|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Up to 96 hours post-dose|Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||ng/ml||Standard Deviation|Mean
2627328|NCT01890785|Primary|Area Under the Plasma Concentration-time Curve (AUC) for Lisdexamfetamine Dimesylate|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Up to 96 hours post-dose|Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||ng*hr/ml||Standard Deviation|Mean
2627329|NCT01890759|Secondary|Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®|Injection site: Tenderness, Erythema, and Swelling. Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability. Grade 3 Injection site: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced. Erythema and Swelling, ≥50 mm. Grade 3 Systemic: Fever, >39.5C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness, Sleeping most of the time or difficult to wake; Appetite lost, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.|Day 0 up to Day 7 post-each vaccination|Solicited injection site and systemic reactions were assessed in the Safety Analysis Set.|||Percentage of participants|||Number
2627383|NCT01890707|Primary|Quality of Recovery - 40 Scores|"The patients self reported quality of recovery - 40 scores as completed 24 hours after the surgical procedure.~40 questions regarding the recovery of patients on a 1 poor-5 excellent scale. Total score on scale 40 (poor recovery)-200 (excellent recovery)"|24 hours||||Units on a scale||Standard Deviation|Mean
2627332|NCT01890759|Secondary|Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set.|||Titers (1/dil)||95% Confidence Interval|Geometric Mean
2627333|NCT01890759|Secondary|Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers were assessed in the Per Protocol Analysis Set.|||Titers (1/dil)||95% Confidence Interval|Geometric Mean
2627334|NCT01890759|Secondary|Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2627335|NCT01890759|Secondary|Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|The threshold was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2627336|NCT01890759|Secondary|Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. The threshold was defined as antibody titers ≥ 1:4.|Day 0 (pre-vaccination) and Day 28 post-vaccination|The threshold was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2627337|NCT01890759|Secondary|Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4.|Day 0 (pre-vaccination) and Day 28 post-vaccination|The threshold was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2627338|NCT01890759|Secondary|Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. The threshold was defined as antibody titers ≥ 1:8.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Threshold was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2627339|NCT01890759|Secondary|Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:8.|Day 0 (pre-vaccination) and Day 28 post-vaccination|The threshold was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2627340|NCT01890759|Secondary|Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|The threshold was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2627341|NCT01890759|Secondary|Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4.|Day 0 (pre-vaccination) and Day 28 post-vaccination|The threshold was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2627342|NCT01890759|Primary|Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®|Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. Seroprotection was defined as antibody titers ≥ 1:8.|Day 0 (pre-vaccination) and Day 28 post-second vaccination|Seroprotection was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2627343|NCT01890746|Secondary|Number of Participants Who Required Medical Resource Utilization|Medical Resource Utilization pertained to unscheduled hospitalizations, unscheduled office visits, unscheduled laboratory tests, and unscheduled procedures.|At screening and from start of treatment to end of therapy/remission assessment visit (Day 42 of the latest chemotherapy cycle)|The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.|||Count of participants|||Number
2627344|NCT01890746|Secondary|Overall Survival (OS)|Overall survival defined as the time form randomization until the date of death due to any cause.|From randomization to end of 2-year follow-up|The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.|||Count of participants|||Number
2627345|NCT01890746|Secondary|Percentage of Participants With Disease Response Rate and Type of Response|"Disease response as assessed by the investigator using the AML International Working Group Response Assessment at the end of therapy/remission assessment visit; Complete remission (CR): defined as transfusion independence, blood count recovery (Abs. neutrophil count > 1.0 Gi/L and Platelet count > 100.0 Gi/L), no leukemic blast in peripheral blood, Bone Marrow (BM) blasts < 5%, maturation of all cell lines, Auer rods not detectable, and no extramedullary disease.~Partial remission (PR): defined as CR except that for BM blasts where a decrease of at least 50% of BM blasts to 5-25% in BM aspirate is sufficient or BM blasts < 5% with Auer rods present.~Overall response (OR) = CR + PR."|Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.|||Percentage of participants|||Number
2627346|NCT01890746|Secondary|Incidence of Hemorrhagic Events|Incidence of bleeding events using WHO bleeding grade (G0=No bleeding, G1=Petechiae, G2=Mild blood loss, G3=Gross blood loss, G4=Debilitating blood loss) by week and cycle|Baseline, weekly within induction and re-induction cycles, end of therapy|The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.|||Participants|||Number
2627347|NCT01890746|Secondary|Summary of Hemoglobin|Hemoglobin level over time|Baseline, daily then weekly within cycle up to 42 days after last chemotherapy dose, end of therapy /remission assessment visit|The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.|||g/L||Full Range|Median
2627348|NCT01890746|Secondary|Summary of Absolute Neutrophil Counts (ANC)|Absolute neutrophil counts over time|Baseline, daily then weekly within cycle up to 42 days after last chemotherapy dose, end of therapy /remission assessment visit|The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.|||Gi/L||Full Range|Median
2627349|NCT01890746|Secondary|Time to Neutrophil Engraftment|Time to absolute neutrophil count (ANC) >= 0.5 Gi/L for 3 consecutive days in participants with ANC < 0.5 Gi/L after chemotherapy|At different time points from last dose of chemotherapy up to end of study year 2 assessment|The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.|||Months||95% Confidence Interval|Median
2627350|NCT01890746|Secondary|Percentage of Patients Who Achieved Platelet Transfusion Independence ≥ 28 Days|Percentage of patients who achieved platelet transfusion independence ≥ 28 days.|From start of treatment and up to end of study year 2 assessment|The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.|||Percentage of participants|||Number
2627351|NCT01890746|Secondary|Maximum Duration (Days) of Platelet Transfusion Independence|Maximum time period (in days) during which the patient did not receive any platelet transfusion|At differnt time points from start of treatment and up to end of study year 2 assessment|The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.|||Days||Full Range|Median
2627352|NCT01890746|Secondary|Summary of Platelet Counts Over Time|Platelet counts over time|Baseline, daily then weekly within cycle up to 42 days after last chemotherapy dose, end of therapy /remission assessment visit|The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.|||Gi/L||Full Range|Median
2627353|NCT01890746|Secondary|Number of Participants Who Achieved Platelet Count Recovery by Day 21|Number of participants with platelet counts 20 Gi/L for 3 consecutive days, unaided by transfusions, in patients with < 20 Gi/L after chemotherapy.|By Day 21|The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.|||Count of participants|||Number
2627354|NCT01890746|Secondary|Time to Platelet Recovery >=100 Gi/L|Time to platelet counts >= 100 Gi/L unaided by transfusions in participants with < 100 Gi/L after chemotherapy.|From last dose of chemotherapy to up to end of study year 2 assessment|The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.|||Months||95% Confidence Interval|Median
2627355|NCT01890746|Secondary|Time to Platelet Count Recovery >=20 Gi/L|Time to Platelet counts >= 20 Gi/L for 3 consecutive days, unaided by transfusions in patients with < 20 Gi/L after chemotherapy. For this endpoint, the event required platelet count to be >= 20 Gi/L for 3 consecutive days. Hematology was assessed daily during hospital stay but only weekly after hospital discharge and thus, platelet count was not always available for 3 consecutive days to confirm the achievement of platelet count recovery.|From last dose of chemotherapy to up to end of study year 2 assessment|The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.|||Months||95% Confidence Interval|Median
2627356|NCT01890746|Secondary|Number of Platelet Transfusions Per Week Within Cycles|This was the average number of platelet transfusions per week within cycles.|Post-Base line up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|The Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not study treatment was administered. This population was based on the treatment to which the subject was randomized.|||Platelet transfusions per week||Standard Deviation|Median
2627357|NCT01890746|Secondary|Cycle 2: Daunorubicinol Dose-normalized Plasma: Cmax|Cycle 2 Daunorubicinol Cmax. PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.|Cycle 2 Day 1 to Day 2 (0 to 24 post-dose)|PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.|||(ug/ml)/(mg/m2)||95% Confidence Interval|Geometric Mean
2627358|NCT01890746|Secondary|Cycle 2: Daunorubicin Dose-normalized Plasma: Cmax|Cycle 2 Daunorubicin Cmax. PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.|Cycle 2 Day 1 to Day 2 (0 to 24 post-dose)|PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.|||(ug/ml)/(mg/m2)||95% Confidence Interval|Geometric Mean
2627359|NCT01890746|Secondary|Cycle 2: Daunorubicinol Dose-normalized Plasma: AUC(0-24)|Cycle 2 Daunorubicinol AUC(0-24). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.|Cycle 2 Day 1 to Day 2 (0 to 24 post-dose)|PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.|||(h*ug/ml)/(mg/m2)||95% Confidence Interval|Geometric Mean
2627360|NCT01890746|Secondary|Cycle 2: Daunorubicin Dose-normalized Plasma: AUC(0-24)|Cycle 2 Daunorubicin AUC(0-24). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.|Cycle 2 Day 1 to Day 2 (0 to 24 post-dose)|PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.|||(h*ug/ml)/(mg/m2)||95% Confidence Interval|Geometric Mean
2627361|NCT01890746|Secondary|Daunorubicinol Dose-normalized Plasma: Cmax|Daunorubicinol Cmax. PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.|Cycle 1 Day 3 to Day 9 (0 to 144 hrs post-dose)|PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.|||(ug/ml)/(mg/m2)||95% Confidence Interval|Geometric Mean
2627362|NCT01890746|Secondary|Daunorubicin Dose-normalized Plasma: Cmax|Daunorubicin Cmax. PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.|Cycle 1 Day 3 to Day 9 (0 to 144 hrs post-dose)|PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.|||(ug/ml)/(mg/m2)||95% Confidence Interval|Geometric Mean
2627363|NCT01890746|Secondary|Daunorubicinol Dose-normalized Plasma: AUC(24-t)|Daunorubicinol AUC(24-t). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.|Cycle 1 Day 4 to Day 9 (24 to 144 hrs post-dose)|PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.|||(h*ug/ml)/(mg/m2)||90% Confidence Interval|Geometric Mean
2627364|NCT01890746|Secondary|Daunorubicin Dose-normalized Plasma: AUC(24-t)|Daunorubicin AUC(24-t). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.|Cycle 1 Day 4 to Day 9 (24 to 144 hrs post-dose)|PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.|||(h*ug/ml)/(mg/m2)||95% Confidence Interval|Geometric Mean
2627365|NCT01890746|Secondary|Daunorubicinol Dose-normalized Plasma: AUC(0-t)|daunorubicinol AUC(0-t). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.|Cycle 1 Day 3 to Day 9 (0 to 144 hrs post-dose)|PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.|||(h*ug/ml)/(mg/m2)||95% Confidence Interval|Geometric Mean
2627366|NCT01890746|Secondary|Daunorubicin Dose-normalized Plasma: AUC(0-t)|Daunorubicin AUC(0-t). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.|Cycle 1 Day 3 to Day 9 (0 to 144 hrs post-dose)|PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.|||(h*ug/ml)/(mg/m2)||95% Confidence Interval|Geometric Mean
2627367|NCT01890746|Secondary|Daunorubicinol Dose-normalized Plasma: AUC(24-∞)|Daunorubicinol AUC(24-∞). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.|Cycle 1 Day 4 to Day 9 (24 to 144 hrs post-dose)|PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.|||(h*ug/ml)/(mg/m2)||95% Confidence Interval|Geometric Mean
2627368|NCT01890746|Secondary|Daunorubicin Dose-normalized Plasma: AUC(24-∞)|Daunorubicin AUC(24-∞). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.|Cycle 1 Day 4 to Day 9 (24 to 144 hrs post-dose)|PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.|||(h*ug/ml)/(mg/m2)||95% Confidence Interval|Geometric Mean
2627369|NCT01890746|Secondary|Daunorubicinol Dose-normalized Plasma: AUC(0-∞)|Daunorubicinol AUC(0-∞). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.|Cycle 1 Day 3 to Day 9 (0 to 144 hrs post-dose)|PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.|||(h*ug/ml)/(mg/m2)||95% Confidence Interval|Geometric Mean
2627370|NCT01890746|Secondary|Daunorubicin Dose-normalized Plasma: AUC(0-∞)|Daunorubicin AUC(0-∞). PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.|Cycle 1 Day 3 to Day 9 (0 to 144 hrs post-dose)|PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.|||(h*ug/ml)/(mg/m2)||95% Confidence Interval|Geometric Mean
2627384|NCT01890694|Secondary|Tolerability of Diuretic Therapy|Improved ability to tolerate diuretic therapy, as evidenced by reduced adverse events to diuretic therapy and reduced risk of re-hospitalization.|Day 1 until Discharge (participants will be followed for the duration of hospital stay, an expected average of 2 weeks)|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.||||||
2627371|NCT01890746|Secondary|Plasma Pharmacokinetics (PK) Parameter of Daunorubicinol: Half-life (t1/2)|Daunorubicinol half-life. PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.|Cycle 1 Day 3 to Day 9 (0 to 144 hrs post-dose)|PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.|||hour (h)||95% Confidence Interval|Geometric Mean
2627372|NCT01890746|Secondary|Plasma Pharmacokinetics (PK) Parameter of Daunorubicin: Half-life (t1/2)|Daunorubicin half-life. PK analyses used actual relative time and actual dosing information in mg/m2. All parameter values were divided by daunorubicin dose in mg/m2 except t1/2.|Cycle 1 Day 3 to Day 9 (0 to 144 hrs post-dose)|PK population: The PK population consisted of all subjects who completed initial induction treatment and had at least 1 non-baseline blood sample for PK obtained and analyzed.|||hour (h)||95% Confidence Interval|Geometric Mean
2627373|NCT01890746|Primary|Worst-case Post Baseline Change in Temperature Values From Baseline|The worst-case post Baseline high and low changes in temperature values from Baseline are presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Post Baseline was defined as the highest and lowest non-missing post Baseline value respectively. Change from Baseline was calculated as the post Baseline value minus the Baseline value.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population. Only those participants available at the indicated time points were analyzed (represented by n=X, X in the category titles).|||Degrees Celsius||Standard Deviation|Mean
2627374|NCT01890746|Primary|Worst-case Post Baseline Change in Blood Pressure Values From Baseline|The worst-case post Baseline high changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) values from Baseline are presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the visit value minus the Baseline value.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2627375|NCT01890746|Primary|Worst-case Change From Baseline in Pulse Rate Values|The worst-case post Baseline high and low changes in pulse rate values from Baseline are presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Post Baseline is defined as the highest and lowest non-missing post Baseline value respectively. Change from Baseline was calculated as the post Baseline value minus the Baseline value.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population. Only those participants available at the indicated time points were analyzed (represented by n=X, X in the category titles)|||Beats/minute||Standard Deviation|Mean
2627376|NCT01890746|Primary|Number of Participants With Worst-case Changes From Baseline in the Eastern Cooperative Oncology Group (ECOG) Performance Status|The number of participants with worst case post-baseline changes (improved, no change, deteriorated) are presented.|Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Participants in the Safety Population who provided Baseline and post-Baseline assessments.|||Participants|||Number
2627377|NCT01890746|Primary|Number of Participants With Worst-case Changes From Baseline in Electrocardiogram (ECG) Values|The number of participants with worst case post-baseline changes (normal, abnormal - not clinically significant [NCS], abnormal - clinically significant [NS]) in ECG QT prolonged values are presented. The protocol does not define the criteria for normal, abnormal-NCS and abnormal CS ECG. The outcome was based solely on the investigator interpretation of ECG tracings.|Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population|||Participants|||Number
2627378|NCT01890746|Primary|Number of Participants With Liver Events.|The number of participants with liver enzyme (ALT, AST, ALP, Total bilirubin) abnormalities while receiving study treatment in each arm are presented.|8 weeks|Safety population|||Participants|||Number
2627379|NCT01890746|Primary|Number of Participants With Worst-case Grade Changes From Baseline in the Clinical Chemistry Parameters|The number of participants with a maximum post-baseline grade increase of Grade 3 or Grade 4 from their baseline grade are presented. Clinical Clinical Chemistry parameters included only lab tests that are gradable by CTCAE v4.0.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population|||Participants|||Number
2627380|NCT01890746|Primary|Number of Participants With Worst-case Grade Changes From Baseline in the Hematology Parameters|The number of participants with a maximum post-baseline grade increase of Grade 3 (G3) or Grade 4 (G4) from their baseline grade are presented. Hematology parameters included only lab tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.|Baseline and up to Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Safety population|||Participants|||Number
2627381|NCT01890746|Primary|Change From Baseline in the Left Ventricular Ejection Fraction (LVEF).|LVEF is a measurement of the percentage of blood leaving heart each time it contracts. LVEF was assessed by an echocardiogram (ECHO) or Multiple Gated Acquisition scan (MUGA). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the Day 42 value minus the Baseline value.|Baseline and Day 42 of the latest chemotherapy cycle (Up to 8 weeks)|Participants in the Safety Population who provided Baseline and Day 42 LVEF measurements.|||LVEF percent||Standard Deviation|Mean
2627382|NCT01890746|Primary|Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE) as a Measure of Safety and Tolerability.|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.|From the time the first dose of study treatment was administered until 30 days following discontinuation of investigational product regardless of initiation of a new cancer therapy or transfer to hospice|Safety population: all subjects who received at least one dose of investigational product.|||Participants|||Number
2627397|NCT01890694|Primary|Length of Hospital Stay|Performance period for sponsored trial expired and not enough subjects were enrolled in study. Funding sponsor did not continue support.|participants will be followed for the duration of hospital stay, an expected average of 2 weeks|Data were not collected due to premature termination of the trial||||||
2627398|NCT01890642|Secondary|Pain at J-tip Deployment|Pain when J-tip deployed assessed by video reviewers using pain scale. The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain.|1 minute||||units on a scale||Inter-Quartile Range|Median
2627399|NCT01890642|Primary|Change in Pain Score on FLACC Scale From Device Deployment to Venipuncture|"Pain score assessed by video reviewer at J-tip, J-tip noise or researcher approach (1 minute) and at venipuncture (3 minutes). The score at J-tip noise/researcher approach was subtracted from the score at venipuncture to give a number indicating the change in pain scores.~The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain."|3 min||||units on a scale||Standard Error|Mean
2627400|NCT01890642|Secondary|Change in Pain Score From Baseline|"Pain score assessed by video reviewer before intervention (0 minute) and at venipuncture (3 minutes). The score at baseline was subtracted from the score at venipuncture to give a number indicating the change in pain scores.~The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain."|3 min||||units on a scale||Standard Error|Mean
2627401|NCT01890642|Secondary|Fist Attempt Success|Proportion of patients where blood draw was successful on first attempt|up to 3 minutes||||participants|||Number
2627402|NCT01890642|Secondary|Pain Score|Pain score as assessed by video reviewers. The FLACC (Face, legs, activity, cry and consolability) Scale, ranging from 0 (no pain) to 10 (worst pain), was used to assess pain.|At venipuncture (3 minutes)||||units on a scale||Inter-Quartile Range|Median
2627403|NCT01890577|Secondary|Number of Hospitalisations|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period|||||||
2627404|NCT01890577|Secondary|Number of Red Blood Cell Transfusions|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period|||||||
2627405|NCT01890577|Secondary|C-Reactive Protein, Albumin, Transferrin Saturation and Serum Ferritin Concentration|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period|||||||
2627406|NCT01890577|Secondary|Use of Concomitant Therapies: Immunosuppressants, Cardiovascular Medications, Secondary Hypoparathyroidism Medications, Anti-retroviral Therapy|Due to the premature termination of the study no outcome measure data were analyzed.|At each 12-week interval over the observation period|||||||
2627407|NCT01890577|Secondary|Iron Therapy Use|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period|||||||
2627408|NCT01890577|Secondary|ESA/Aranesp Dose Ratio|"Ratio of the calculated mean weekly dose equivalent of an ESA administered immediately prior to conversion to treatment with Aranesp, to the calculated mean weekly dose equivalent of the first dose of Aranesp administered at commencement. Not applicable to participants who were ESA-naive at time of Aranesp commencement.~Due to the premature termination of the study no outcome measure data were analyzed."|Day of commencement of Aranesp|||||||
2627409|NCT01890577|Secondary|Erythropoiesis Stimulating Agent (ESA) Usage|Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period|||||||
2627410|NCT01890577|Secondary|Hemoglobin Within the Range 10-12 g/dL Over Time|Due to the premature termination of the study no outcome measure data were analyzed.|On a continuous basis over the 15-month observation period|||||||
2627411|NCT01890577|Secondary|Hemoglobin Excursions|Hemoglobin excursions defined as hemoglobin <10g/dL and >12g/dL. Due to the premature termination of the study no outcome measure data were analyzed.|Over the 15-month observation period|||||||
2627412|NCT01890577|Primary|Haemoglobin Concentration|Due to the premature termination of the study no outcome measure data were analyzed.|Each 4-week period for the duration of the study period (15 months)|||||||
2627413|NCT01890512|Primary|Number of MRI Related Patient Adverse Events and/or Adverse Device Effects During MRI Visit|"The study is aimed at providing confirmatory data of no impact of MRI on device function and patient conditions.~Confirmation of no MRI related patient adverse events and/or adverse device effects during MRI visit are assessed as follows:~no episodes of asystole,~no occurrence of sustained ventricular arrhythmias in the bore,~no loss of capture due to rise in pacing threshold."|one month||||number of MRI related patient adverse ev|||Number
2627414|NCT01890473|Secondary|Number of Participants With Blood Hematology, Chemistry Laboratory Values and Urinalysis Laboratory Values Meeting the Marked Abnormality Criteria|Marked abnormality criteria: lower limit of normal (LLN); upper limit of normal (ULN); pretreatment (preRX); cells per microliter (cµ/L); milligram per deciliter (mg/dL); milliequivalent (mEq): Hematology: leukocytes (*10^3 c/µL): <0.75*LLN or >1.25*ULN, or if preRX <LLN, use <0.8*preRX or >ULN, or if preRX>ULN, use >1.2*preRX or <LLN; eosinophils (*10^3 cµ/L): if value >0.750*10^3 c/µL; lymphocytes (*10^3 cµ/L): if value <0.750*10^3 c/µL or if value >7.50*10^3 c/µL. Chemistry: blood urea nitrogen (mg/dL): >2*preRX; creatinine (mg/dL): >1.5*preRX; potassium (mEq/L): <0.9*LLN or >1.1*ULN, or if preRX<LLN, use <0.9*preRX or >ULN, or if preRX>ULN, use 1.1*preRX or <LLN; glucose (mg/dL): <65 mg/dL (low) or >220 mg/dL (high). Urine Blood, urine red blood cell (RBC), urine white blood cell (WBC): if missing PreRX use >= 2, or if Value >= 4, or if preRX = 0 or 0.5 then use >= 2, or if preRX = 1 then use >= 3, or if preRX = 2 or 3 then use >= 4.|Day 1 to 76 days post last dose|All treated participants with laboratory values were included in the safety analysis. n=number of participants evaluated.|||participants|||Number
2627424|NCT01890473|Primary|Adjusted Geometric Mean of Maximum Observed Serum Concentration (Cmax) of a Single Dose of Subcutaneous (SC) Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Cmax was measured in micrograms per milliliter (μg/mL). Blood samples for pharmacokinetic (PK) parameters were collected at Day 1 pre-dose at 0 hour (h), 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC.|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.|||μg/mL||90% Confidence Interval|Geometric Mean
2627415|NCT01890473|Secondary|Number of Participants With a Positive Immunogenicity Response Relative to Baseline|Blood samples were screened at baseline, Day 57 and Day 71 for the presence of drug-specific antibodies using Electrochemiluminescence (ECL). A positive immunogenicity response relative to baseline for Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4) and 'possibly immunoglobulin (Ig)', and 'Ig and/or Junction Region', respectively, was defined as: A missing baseline immunogenicity measurement and a positive analytical laboratory reported immunogenicity response post-baseline; A negative baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline; A positive baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline that has a titer value strictly greater than the baseline titer value. Baseline=Pre-dose value.|Day 57, Day 71|All treated participants with at least one post baseline immunogenicity result reported were included in the immunogenicity analysis. n=number of participants evaluated at the specific time point.|||participants|||Number
2627416|NCT01890473|Secondary|Number of Participants With Adverse Events of Special Interest|Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Infections, Autoimmune Disorders, Malignancy, local site reactions, any AE occurring within 24 hours of SC injection. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day 1 to 76 days post single dose|All treated participants were included in safety analysis.|||participants|||Number
2627417|NCT01890473|Secondary|Number of Participants Who Had Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Discontinuation, or Who Died|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Includes data Day 1 up to 76 days (71 days + 5 day window) post the single dose of study drug.|Day 1 to 76 days post single dose|All treated participants were included in safety analysis.|||participants|||Number
2627418|NCT01890473|Secondary|Geometric Mean of Volume of Distribution (V/F) of a Single Dose of Subcutaneous (SC) Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. V/F was measured in liters per kilogram body weight (L/kg)|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.|||L/kg||Geometric Coefficient of Variation|Geometric Mean
2627419|NCT01890473|Secondary|Geometric Mean of Total Body Clearance (CL/F) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. CL/F was measured in milliliters per hour per kilogram body weight (mL/h/kg).|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.|||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
2627420|NCT01890473|Secondary|Mean of Terminal Phase Elimination Half-life in Serum (T-HALF) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. T-HALF was measured in hours (h).|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.|||h||Standard Deviation|Mean
2627421|NCT01890473|Secondary|Median of Time to Reach Cmax in Serum (Tmax) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. Tmax was measured in hours (h).|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.|||h||Full Range|Median
2627422|NCT01890473|Primary|Adjusted Geometric Mean of Area Under the Serum Concentration-time Curve From Time Zero to Extrapolated to Infinity, AUC (INF), of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 hour (h), 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. AUC (INF) was measured in μg*h/mL|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.|||μg*h/mL||90% Confidence Interval|Geometric Mean
2627423|NCT01890473|Primary|Adjusted Geometric Mean of Area Under the Serum Concentration-time Curve (AUC) From Zero to the Last Time of the Last Quantifiable Concentration (0-T) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population|Serum concentrations of abatacept were analyzed using ELISA. AUC (0-T) was measured in μg*h/mL. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC.|Day 1 to Day 71|PK-evaluable analysis population: All randomized and treated participants with adequately evaluable PK parameters were summarized.|||μg*h/mL||90% Confidence Interval|Geometric Mean
2627740|NCT01885910|Secondary|Dryness|the dryness severity scale ranges from 0 to 4 with 0 being no dryness and 4 being most extreme dryness|every 4 weeks|participants with data|||units on a scale||Standard Deviation|Mean
2627425|NCT01890434|Secondary|Number of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessment|Score for confidence in diagnosis (not confident, somewhat confident, and confident) was described descriptively for each of the 6 myocardial regions. The frequency over the worst confidence in diagnosis obtained within a participant was displayed. All these analyses were done separately for gadobutrol-enhanced CMRI and unenhanced wall motion CMRI.|0 to 30/40 min post-injection|FAS|||Participants|||Count of Participants
2627426|NCT01890434|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator|Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI and GSPECT in participants with single-vessel diseases. If >=1 myocardial region showed a myocardial perfusion defect with a RPS of >=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of >=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.|0 to 30/40 min post-injection|Participants in FAS with multi-vessel disease indicating significant CAD (defined as QCA stenosis of >=70%) as verified by SoR.|||Sensitivity %|||Number
2627427|NCT01890434|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single-vessel Disease Evaluated on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity by Majority Blinded Reader and Investigator|Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI and GSPECT in participants with single-vessel diseases. If >=1 myocardial region showed a myocardial perfusion defect with a RPS of >=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of >=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.|0 to 30/40 min post-injection|Participants in FAS with single-vessel disease indicating significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR.|||Sensitivity %|||Number
2627428|NCT01890434|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD in Participants With Single or Multi-vessel Disease Evaluated on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment|Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI in participants with single and multi-vessel diseases. If >=1 myocardial region showed a myocardial perfusion defect with a RPS of >=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
2627429|NCT01890434|Secondary|Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessment|Number of participants with myocardial perfusion defects on gadobutrol-enhanced CMRI was calculated in participants with significant left main stem (LMS) stenosis and the myocardial perfusion defect pattern was described. If >=1 myocardial region showed a myocardial perfusion defect with a RPS of >=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%).|0 to 30/40 min post-injection|Participants in FAS with significant LMS stenosis indicating significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR.|||Participants|||Count of Participants
2627430|NCT01890434|Secondary|Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment|Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=70%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of specificity was retrospective analysis.|0 to 30/40 min post-injection|Participants in FAS without significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR in each coronary territory, with either blinded reading or investigator reading.|||Specificity %|||Number
2627431|NCT01890434|Secondary|Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment|Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers, majority blinded reader and the investigator. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.|0 to 30/40 min post-injection|Participants in FAS without significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR and available GSPECT in each coronary territory, with either blinded reading or investigator reading,|||Specificity %|||Number
2627475|NCT01890226|Secondary|Change in Patient Activation Measure|Assesses a patients' perceived ability to manage their illnesses and their healthcare visits. Patient Activation Measure Scores were summed to calculate the overall raw score then transformed to an activation scale ranging from 0 to 100. Higher scores indicate greater patient activation.|Baseline, 6 month post intervention, 12 month post intervention|Completion rates for patient interviews were 91.9% at 6-months and 84.6% for 12 months, with similar rates of attrition in both groups.|||score on a scale||Standard Deviation|Mean
2633192|NCT01828112|Secondary|Disease Control Rate (DCR)|DCR is defined as the proportion of patients with best overall response of CR, PR, or stable disease (SD)|Month 18||2023-07-31|07/2023||||
2627432|NCT01890434|Secondary|Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessment|Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator.|0 to 30/40 min post-injection|Participants in FAS without significant CAD (defined as QCA stenosis of >= 50% by) as verified by SoR in each coronary territory, with either blinded reading or investigator reading performed.|||Specificity %|||Number
2627433|NCT01890434|Secondary|Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment|Sensitivity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=70%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of sensitivity was retrospective analysis.|0 to 30/40 min post-injection|Participants in FAS with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR in each coronary territory, with either blinded reading or investigator reading performed.|||Sensitivity %|||Number
2627434|NCT01890434|Secondary|Localization of a Myocardial Perfusion Defect to LAD and Non-LAD Territory on GSPECT - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment|Sensitivity was calculated coronary territory based, a coronary territory (LAD / non-LAD) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers, majority blinded reader and the investigator. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.|0 to 30/40 min post-injection|Participants in FAS with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR and available GSPECT in each coronary territory, with either blinded reading or investigator reading performed.|||Sensitivity %|||Number
2627435|NCT01890434|Secondary|Localization of a Myocardial Perfusion Defect to Each Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessment|Sensitivity was calculated coronary territory based, a coronary territory (left anterior descending artery [LAD] / non-LAD / right coronary artery [RCA] / left circumflex artery [LCX]) was rated positive for significant CAD (significant CAD defined as QCA stenosis of>=50%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers, majority blinded reader and the investigator.|0 to 30/40 min post-injection|Participants in FAS with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR in each coronary territory.|||Sensitivity %|||Number
2627436|NCT01890434|Secondary|Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Specificity Based on Majority Blinded Reader's and Investigator's Assessment|Absence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Specificity= true negative/(true negative + false positive). This additional secondary analysis of specificity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.|0 to 30/40 min post-injection|Participants in FAS with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR, for assessment on gadobutrol-enhanced CMRI, and available GSPECT for assessment on GSPECT.|||Specificity %|||Number
2627437|NCT01890434|Secondary|Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT -- Secondary Analysis of Specificity Comparison Based on Majority Blinded Reader's and Investigator's Assessment|Absence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of >=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Specificity= true negative/(true negative + false positive). Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.|0 to 30/40 min post-injection|Participants in FAS (all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR and available GSPECT.|||Specificity %|||Number
2627476|NCT01890226|Secondary|Change in Patient Assessment of Chronic Illness Care|20-item patient self-report instrument that assesses the extent to which patients with chronic illness report receiving care that aligns with the Chronic Care Model. The summary score ranges from 1 to 5 with a higher score indicating patient's perception of greater involvement in self-management and receipt of chronic care counseling.|Baseline, 6 month post intervention, 12 month post intervention|Completion rates for patient interviews were 91.9% at 6-months and 84.6% for 12 months, with similar rates of attrition in both groups.|||score on a scale||Standard Deviation|Mean
2627741|NCT01885910|Secondary|Erythema|the erythema severity scale ranges from 0 to 4 with 0 being no erythema and 4 being most extreme erythema|every 4 weeks|participants with data|||units on a scale||Standard Deviation|Mean
2627438|NCT01890434|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI and GSPECT - Additional Secondary Analysis of Sensitivity Based on Majority Blinded Reader's and Investigator's Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader and investigator's assessment. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis. Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.|0 to 30/40 min post-injection|Participants in FAS with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR, for assessment on gadobutrol-enhanced CMRI, and available GSPECT for assessment on GSPECT.|||Sensitivity %|||Number
2627439|NCT01890434|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus GSPECT - Secondary Analysis of Sensitivity Comparison Based on Majority Blinded Reader's and Investigator's Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus GSPECT (based on RPS of the 6 myocardial regions) was calculated by majority blinded reader (BR) and investigator's assessment. Significant CAD was defined as QCA stenosis of >=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or GSPECT verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). Blinded reading of the gadobutrol-enhanced CMRI images and GSPECT images was performed by different readers.|0 to 30/40 min post-injection|Participants in FAS (all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR and available GSPECT.|||Sensitivity %|||Number
2627440|NCT01890434|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Investigator's Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis.|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR.|||Sensitivity %|||Number
2627441|NCT01890434|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Secondary Analysis of Sensitivity Comparison Based on the Investigator's Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was defined as QCA stenosis of >=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR.|||Sensitivity %|||Number
2627442|NCT01890434|Secondary|Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Investigator's Assessment|The investigator evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was retrospective analysis.|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR.|||Specificity %||95% Confidence Interval|Number
2627454|NCT01890421|Secondary|Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Versus Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments|Sensitivity was calculated for detection of myocardial perfusion defects (MPD) on gadobutrol-enhanced CMRI in participants with single and multi-vessel diseases. If >=1 myocardial region showed a myocardial perfusion defect with a RPS of >=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
2627742|NCT01885910|Secondary|Nodule Counts|number of nodules counted|every four weeks|participants with data|||nodules||Standard Deviation|Mean
2627443|NCT01890434|Secondary|Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Investigator's Assessment|The investigator evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Specificity= true negative/ (true negative + false positive).|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR.|||Specificity %||95% Confidence Interval|Number
2627444|NCT01890434|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Investigator's Assessment|The investigator evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis.|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
2627445|NCT01890434|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Investigator's Assessment|The investigator evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=50%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
2627446|NCT01890434|Primary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis.|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR.|||Sensitivity %|||Number
2627447|NCT01890434|Primary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as QCA stenosis of >=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR.|||Sensitivity %|||Number
2627455|NCT01890421|Secondary|Detection of Myocardial Perfusion Defect(s) on Gadobutrol-enhanced CMRI in Participants With Significant LMS Stenosis - Based on Blinded Readers' and Investigator's Assessments|Sensitivity was calculated for detection of myocardial perfusion defects on gadobutrol-enhanced CMRI in participants with significant left main stem (LMS) stenosis and the myocardial perfusion defect pattern was described. If >=1 myocardial region showed a myocardial perfusion defect with a RPS of >=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR in the LMS.|||Participants|||Number
2627448|NCT01890434|Primary|Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' Assessment|Blinded readers evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was retrospective analysis.|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR.|||Specificity %||95% Confidence Interval|Number
2627449|NCT01890434|Primary|Absence of Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Primary Analysis of Specificity Based on Blinded Readers' Assessment|Blinded readers evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Specificity= true negative/ (true negative + false positive).|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) without significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR.|||Specificity %||95% Confidence Interval|Number
2627450|NCT01890434|Primary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' Assessment|Blinded readers evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as QCA stenosis of >=70%, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI verified by SoR (CA or CTA [only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was retrospective analysis.|0 to 30/40 min post-injection|Participants in FAS (included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 70%) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
2627451|NCT01890434|Primary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Primary Analysis of Sensitivity Based on Blinded Readers' Assessment|Blinded readers evaluated 6 myocardial regions based on regional perfusion score [RPS: 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of >=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR, coronary angiography [CA] or computed tomography angiography [CTA, only if disease can be unequivocally rejected]). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|Participants in FAS (full analysis set, included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for the SoR diagnosis were available) with significant CAD (defined as QCA stenosis of >= 50%) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
2627452|NCT01890421|Secondary|Percentage of Participants by Their Lowest Confidence in Diagnosis Obtained on Gadobutrol-enhanced CMRI and Unenhanced Wall Motion CMRI - Based on Blinded Readers' and Investigator's Assessments|Score for confidence in diagnosis (not confident, somewhat confident, and confident) was described descriptively for each of the 6 myocardial regions. The frequency over the worst confidence in diagnosis obtained within a participant was displayed. All these analyses were done separately for gadobutrol-enhanced CMRI and unenhanced wall motion CMRI.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Percentage of Participants|||Number
2627453|NCT01890421|Secondary|Presence/Absence of a MPD Indicating/Excluding Significant CAD in Participants With Multi Vs Single Vessel Disease Evaluated on Gadobutrol-enhanced CMRI-Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments|Sensitivity was calculated for detection of MPD on gadobutrol-enhanced CMRI in participants with single and multi-vessel diseases. If >=1 myocardial region showed a myocardial perfusion defect with a RPS of >=1, participants will be rated positive for significant CAD (significant CAD defined as QCA stenosis of >=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=70% by QCA) as verified by SoR.|||Sensitivity %|||Number
2627456|NCT01890421|Secondary|Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments|Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=70%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of specificity was prospective analysis.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=70% by QCA) as verified by SoR.|||Specificity %|||Number
2627457|NCT01890421|Secondary|Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Blinded Readers' and Investigator's Assessments|Specificity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=50%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Specificity was displayed for all 3 blinded readers and the investigator.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Specificity %|||Number
2627458|NCT01890421|Secondary|Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments|Sensitivity was calculated coronary territory based, a coronary territory (LAD / non-LAD / RCA / LCX) was rated positive for significant CAD (significant CAD defined as QCA stenosis of >=70%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory (LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers and the investigator. This additional secondary analysis of sensitivity was prospective analysis.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=70% by QCA) as verified by SoR.|||Sensitivity %|||Number
2627459|NCT01890421|Secondary|Localization of a Myocardial Perfusion Defect to a Coronary Territory on Gadobutrol-Enhanced CMRI - Secondary Analysis of Sensitivity Based on Blinded Readers' and Investigator's Assessments|Sensitivity was calculated coronary territory based, a coronary territory (left anterior descending artery [LAD] / non-LAD / right coronary artery [RCA] / left circumflex artery [LCX]) was rated positive for significant CAD (significant CAD defined as QCA stenosis of>=50%), if >=1 myocardial region within the same coronary territory showed a myocardial perfusion defect with a RPS of >=1. A coronary territory(LAD / non-LAD) was rated negative for significant CAD, if no myocardial region within the respective coronary territory showed a myocardial perfusion defect (RPS 0). Sensitivity was displayed for all 3 blinded readers and the investigator.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Sensitivity %|||Number
2627460|NCT01890421|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment|Investigator's assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator's assessment of participant-based sensitivity and specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of >=70% by QCA, which were secondary analysis. Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=70% by QCA) as verified by SoR.|||Sensitivity %|||Number
2627461|NCT01890421|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment|Investigator's assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator's assessment of participant-based sensitivity and specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of >=50% by QCA, which were secondary analysis. Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Sensitivity %|||Number
2627462|NCT01890421|Secondary|Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Investigator's Assessment|Investigator's assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator's assessment of participant-based specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of >=70% by QCA, which were secondary analysis. Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was prospective analysis.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=70% by QCA) as verified by SoR.|||Specificity %||95% Confidence Interval|Number
2627463|NCT01890421|Secondary|Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Investigator's Assessment|Investigator's assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator's assessment of participant-based specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum stenosis severity of >=50% by QCA, which were secondary analysis. Specificity= true negative/ (true negative + false positive).|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Specificity %||95% Confidence Interval|Number
2627464|NCT01890421|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (significant CAD defined as QCA stenosis of >=70%). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=70% by QCA) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
2627465|NCT01890421|Secondary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Investigator's Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (significant CAD defined as QCA stenosis of >=50%). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
2627466|NCT01890421|Primary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of >=70% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=70% by QCA) as verified by SoR.|||Sensitivity %|||Number
2627474|NCT01890226|Secondary|Change in Health-related Quality of Life|"Measured using the Physical and Mental Component Summary scales of the SF-12. Assesses a patients' perceived health related quality of life.~The composite physical (PCS) and mental component (MCS) summary scores for the SF-12 are each scored on a 0-100 scale. Higher scores indicate better functioning."|Baseline, 6 month post intervention, 12 month post intervention|Completion rates for patient interviews were 91.9% at 6-months and 84.6% for 12 months, with similar rates of attrition in both groups.|||score on a scale||Standard Deviation|Mean
2627561|NCT01888900|Secondary|Sustained Virological Responder|sustained virological response at follow-up week 12|Week 12 post treatment||||Participants|||Count of Participants
2627562|NCT01888900|Secondary|End of Treatment Responder|end of treatment response (HCV RNA <LLOQ Target not Detected at week24)|Week 24 post treatment||||Participants|||Count of Participants
2627467|NCT01890421|Primary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment|Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of >=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Sensitivity %|||Number
2627468|NCT01890421|Primary|Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Specificity Based on the Blinded Readers' Assessment|Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of >=70% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Specificity= true negative/ (true negative + false positive). This additional secondary analysis of specificity was prospective analysis.|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=70% by QCA) as verified by SoR.|||Specificity %||95% Confidence Interval|Number
2627469|NCT01890421|Primary|Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Specificity Based on the Blinded Readers' Assessment|Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of >=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Specificity= true negative/ (true negative + false positive).|0 to 30/40 min post-injection|FAS included all participants who underwent pharmacologic stress and for whom eCRF entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS participants with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Specificity %||95% Confidence Interval|Number
2627470|NCT01890421|Primary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Sensitivity Based on the Blinded Readers' Assessment|Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of >=70% for secondary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative). This additional secondary analysis of sensitivity was prospective analysis.|0 to 30/40 min post-injection|FAS: participants who underwent pharmacologic stress and for whom electronic case report form (eCRF) entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS with significant CAD (defined as maximum stenosis severity of >=70% by QCA) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
2627471|NCT01890421|Primary|Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Sensitivity Based on Blinded Readers' Assessment|Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)]. A myocardial region a perfusion defect in case of a RPS of >=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of >=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (true positive + false negative).|0 to 30/40 minute (min) post-injection|Full analysis set (FAS): participants who underwent pharmacologic stress and for whom electronic case report form entries, adequate image sets for unenhanced and gadobutrol-enhanced CMRI, and the complete image set for SoR diagnosis were available. N=FAS with significant CAD (defined as maximum stenosis severity of >=50% by QCA) as verified by SoR.|||Sensitivity %||95% Confidence Interval|Number
2627472|NCT01890343|Primary|Quantitative Amyloid Image Assessment|The effect of diagnostic group on mean total cortical grey matter florbetapir binding relative to cerebellar cortex is presented as standard uptake value ratios (SUVr).|50-60 minutes after injection||||SUVr||Standard Deviation|Mean
2627473|NCT01890343|Primary|Qualitative Amyloid Image Assessment|Four readers blinded to all clinical information classified florbetapir Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read classification is presented as either positive, negative or tied.|50-60 min after injection||||participants|||Number
2627477|NCT01890226|Primary|Change in Composite Quality Score|It is a measure of quality of care. The aggregate score represents the total number of eligible services received for an individual generated by dividing all instances in which recommended care was delivered by the number of times a participant was eligible for the indicator. The score ranges from 0 to 1 with higher scores indicating receipt of recommended care/services.|Baseline, 12 month post intervention|Chart review data, which were used to assess overall quality of care, were available for all participants at baseline and 12-month follow-up.|||score on a scale||Standard Deviation|Mean
2627478|NCT01890148|Secondary|Summary Statistics for Patient Diary Variables (Night Time)|"Summary statistics for patient diary variable, observations with no asthma symptoms (night time), by period (safety set).~The screening period was Day -14 to -1. Period 1 was the first half of treatment period, Day 1 to daytime record Day 15. Period 2 was the second half of treatment period, night-time record Day 15 to night-time record Day 29+1.~One participant left the study on day 2, due to adverse event."|Up to 44 days||||Observations|Participants||Number
2627479|NCT01890148|Secondary|Summary Statistics for Patient Diary Variables (Day Time)|"Summary statistics for patient diary variable, observations with no asthma symptoms (day time), by period (safety set).~The screening period was Day -14 to -1. Period 1 was the first half of treatment period, Day 1 to daytime record Day 15. Period 2 was the second half of treatment period, night-time record Day 15 to night-time record Day 29+1.~One participant left the study on day 2, due to adverse event."|Up to 44 days||||Observations|Participants||Number
2627480|NCT01890148|Secondary|Number of Participants With Adverse Events|Summary of number of participants with adverse events (safety set)|Up to 40 days||||Participants|||Number
2627481|NCT01890148|Secondary|Number of Adverse Events|Summary of number of adverse events (safety set)|Up to 40 days||||adverse events|||Number
2627482|NCT01890148|Secondary|Summary Statistics for Cmax on Day 29/ Visit T7 (PK Analysis Set)|"Summary statistics including geometric mean and standard error for Cmax on Day 29/ Visit T7 (PK analysis set).~Plasma concentration data beyond 0.5 hrs post dose at Day 29 were missing for one patient. For this patient only Cmin value was reported and the AUC0-4hrs and Cmax values were not reported."|At 0, 0.5, 1, 1.5, 2, 2.5, 3, 4 hours post dose on Day 29 (Visit T7)||||nmol/L||Standard Error|Geometric Mean
2627483|NCT01890148|Secondary|Summary Statistics for Cmin on Day 29/ Visit T7 (PK Analysis Set)|"Summary statistics including geometric mean and standard error for Cmin on Day 29/ Visit T7 (PK analysis set).~Plasma concentration data beyond 0.5 hrs post dose at Day 29 were missing for one patient. For this patient only Cmin value was reported and the AUC0-4hrs and Cmax values were not reported."|At 0, 0.5, 1, 1.5, 2, 2.5, 3, 4 hours post dose on Day 29 (Visit T7)||||nmol/L||Standard Error|Geometric Mean
2627484|NCT01890148|Secondary|Summary Statistics for AUC0-4hrs on Day 29/ Visit T7 (PK Analysis Set)|"Summary statistics including geometric mean and standard error for AUC0-4hrs on Day 29/ Visit T7 (PK analysis set).~Plasma concentration data beyond 0.5 hrs post dose at Day 29 were missing for one patient. For this patient only Cmin value was reported and the AUC0-4hrs and Cmax values were not reported."|At 0, 0.5, 1, 1.5, 2, 2.5, 3, 4 hours post dose on Day 29 (Visit T7)||||h*nmol/L||Standard Error|Geometric Mean
2627485|NCT01890148|Secondary|Summary for Change From Baseline for MMP-9 by Type of Sample|Change from baseline reflects the Day 29 value minus the baseline value.|Baseline and Day 29|PD analysis|||ng/ml||Standard Deviation|Mean
2627486|NCT01890148|Secondary|Summary for Change From Baseline for GRO-alpha by Type of Sample|Change from baseline reflects the Day 29 value minus the baseline value.|Baseline and Day 29|PD analysis set|||pg/ml||Standard Deviation|Mean
2627487|NCT01890148|Secondary|Summary for Change From Baseline for IL-8 by Type of Sample|Change from baseline reflects the Day 29 value minus the baseline value.|Baseline and Day 29|PD analysis set|||pg/ml||Standard Deviation|Mean
2627488|NCT01890148|Primary|Summary for Change From Baseline Neutrophil Cell Counts in Blood|Change from Baseline reflects the Day 2, Day 8, Day 15, Day 22, Day29 and Day 34 minus the baseline value|Baseline, Day 2, Day 8, Day 15, Day 22, Day29 and Day 34|PD Analysis|||10^9 cells/L||Standard Deviation|Mean
2627489|NCT01890148|Primary|Summary for Change From Baseline Neutrophils in Sputum|Change from Baseline reflects the Day 8, Day22 and Day29 minus the baseline value.|Baseline, Day 8, Day 22 and Day29|PD analysis set|||10^9 cells/L||Standard Deviation|Mean
2627490|NCT01890148|Primary|Summary for Change From Baseline of Mean Global Semi-quantitative Score Values for Neutrophils in Bronchial Biopsies|"Change from baseline reflects the Week 4 value minus the baseline value. Baseline value is Day-14 measurement.~For semi-quantitative scores, 1= few number of Neutrophils, 2= moderate number of Neutrophils, 3= abundant of Neutrophils. For this end point the reduction in mean of semi-quantitative (arbitrary) scores indicates better result, i.e. lower numbers of Neutrophils.~The scores given for the biopsies taken at screening and end of treatment is the mean global semi-quantitative scores for the three compartments intraepithelial, subepithelial and submucosal."|Baseline and Week 4|PD analysis set|||Units on a scale||Standard Deviation|Mean
2627491|NCT01890122|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥2.0%|Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥2.0%.|Baseline and Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.|||percentage of participants|||Number
2627492|NCT01890122|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.5%|Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥1.5%.|Baseline and Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.|||percentage of participants|||Number
2627563|NCT01888900|Secondary|Extended Rapid Virological Responder|extended rapid virological response (HCV RNA <LLOQ Target not Detected at both weeks 4 and 12)|Both weeks 4 and 12 post treatment||||Participants|||Count of Participants
2627564|NCT01888900|Secondary|Rates of Rapid Virological Responder|rapid virological response (HCV RNA <LLOQ Target not Detected) at week 4|Week 4 post treatment||||Participants|||Count of Participants
2627493|NCT01890122|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥1.0%|Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥1.0%.|Baseline and Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.|||percentage of participants|||Number
2627494|NCT01890122|Secondary|Percentage of Participants With a Decrease in Glycosylated Hemoglobin ≥0.5%|Clinical response at Week 26 will be assessed by the percentage of participants with a decrease from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of ≥0.5%.|Baseline and Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.|||percentage of participants|||Number
2627495|NCT01890122|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤7.5%|Clinical response at Week 26 will be assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) ≤7.5%.|Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.|||percentage of participants|||Number
2627496|NCT01890122|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤7.0%|Clinical response at Week 26 will be assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) ≤7%.|Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.|||percentage of participants|||Number
2627497|NCT01890122|Secondary|Percentage of Participants With Glycosylated Hemoglobin ≤6.5%|Clinical response at Week 26 will be assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) ≤6.5%.|Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.|||percentage of participants|||Number
2627498|NCT01890122|Secondary|Change From Baseline in Body Weight at Weeks 12 and 26|Change in participant's body weight at Weeks 12 and 26 relative to baseline.|Baseline and Weeks 12 and 26|"Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized. n in the category is the number of participants with data available at the given time-point."|||kg||Standard Deviation|Median
2627499|NCT01890122|Secondary|Percentage of Participants With Marked Hyperglycemia|Marked hyperglycemia is defined as FPG level ≥200 mg/dL (11.1 mmol/L).|Baseline up to Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.|||percentage of participants|||Number
2627500|NCT01890122|Secondary|Percentage of Participants Requiring Hyperglycemic Rescue|Rescue is defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days of first sample: After >1 week of treatment but prior to Week 4 visit: A single FPG ≥275 mg/dL (≥15.27 mmol/L); From the Week 4 but prior to the Week 8 visit: A single FPG ≥250 mg/dL (≥13.88 mmol/L); From the Week 8 visit but prior to the Week 12 visit: A single FPG ≥225 mg/dL (≥12.49 mmol/L); From the Week 12 visit through the end-of-treatment visit (week 26): HbA1c ≥8.5% and ≤0.5% reduction in HbA1c from baseline.|Baseline up to Week 26|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized.|||percentage of participants|||Number
2627501|NCT01890122|Secondary|Time to Hyperglycemic Rescue Event|Rescue is defined as meeting one of the following criteria, confirmed by a second sample drawn within 7 days of first sample: After >1 week of treatment but prior to Week 4 visit: A single FPG ≥275 mg/dL (≥15.27 mmol/L); From the Week 4 but prior to the Week 8 visit: A single FPG ≥250 mg/dL (≥13.88 mmol/L); From the Week 8 visit but prior to the Week 12 visit: A single FPG ≥225 mg/dL (≥12.49 mmol/L); From the Week 12 visit through the end-of-treatment visit (week 26): HbA1c ≥8.5% and ≤0.5% reduction in HbA1c from baseline. Time to hyperglycemic rescue was censored if the participant did not experience a hyperglycemic rescue event.|From the date of randomization through Week 26|Randomized set consisted of all enrolled participants who were randomized.|||days||Inter-Quartile Range|Median
2627502|NCT01890122|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 8, 12, 16, 20 and 26|The change between the FPG value collected at Weeks 4, 8, 12, 16, 20 and 26 relative to baseline. Negative change indicates better glycemic control.|Baseline and Weeks 4, 8, 12, 16, 20 and 26|"Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized. n in the category is the number of participants with data available at the given time-point."|||mg/dL||Standard Deviation|Mean
2627503|NCT01890122|Secondary|Change From Baseline in HbA1c at Weeks 4, 8, 12, 16 and 20|The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Weeks 4, 8, 12, 16 and 20 relative to baseline. Negative change indicates better glycemic control.|Baseline and Weeks 4, 8, 12, 16 and 20|"Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. LOCF imputation was utilized. n in the category is the number of participants with data available at the given time-point."|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2627600|NCT01888367|Secondary|Number of Patients With Adverse Events||Within 30 days of surgery|"The safety analysis was as treated. For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the patients who did not receive gel were counted in the SOC group."|||participants|||Number
2627504|NCT01890122|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 (or Early Termination)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 26 or early termination relative to baseline. Negative change indicates better glycemic control.|Baseline and Week 26 (or Early termination)|Full analysis set consisted of all randomized participants in the safety set (participants who received at least 1 dose of study drug) who had baseline and at least 1 post baseline assessment. Last observation carried forward (LOCF) imputation was utilized.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2627505|NCT01890109|Secondary|Number of Participants Who Developed Anti-erenumab Antibodies After a Single Dose|"Two validated assays were used to detect the presence of anti-erenumab antibodies. First, an electrochemiluminescent (ECL) bridging immunoassay was used to detect antibodies capable of binding erenumab. Second, a cell based bioassay was used to test positive binding antibody samples for neutralizing activity against erenumab.~A participant was defined as positive for developing anti-erenumab antibodies if they were binding antibody positive postbaseline with a negative or no result at baseline. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the participant was defined as positive for neutralizing antibodies."|16 weeks|All participants who received study drug.|||Participants|||Count of Participants
2627506|NCT01890109|Secondary|Number of Participants With Treatment-emergent Suicidal Ideation|"The Columbia Suicide Severity Rating Scale (C-SSRS) was used to assess suicidal ideation during the study based on the following Yes/No questions:~Have you wished you were dead or wished you could go to sleep and not wake up?~Have you actually had any thoughts of killing yourself?"|16 weeks|All participants who received study drug|||Participants|||Count of Participants
2627507|NCT01890109|Secondary|Terminal Half-life (T1/2) of Erenumab||Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose|All participants who received erenumab and for whom at least 1 PK parameter or endpoint could be adequately estimated. T1/2 could not be accurately estimated for 23 participants who are excluded from the analysis. The terminal half-life calculated from this single dose study may not be representative of a clinically relevant half-life of erenumab.|||days||Standard Deviation|Mean
2627508|NCT01890109|Secondary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for Erenumab||Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose|All participants who received erenumab and for whom at least 1 pharmacokinetic (PK) parameter or endpoint could be adequately estimated. AUCinf could not be accurately estimated for 23 participants who are excluded from the analysis.|||day*μg/mL||Standard Deviation|Mean
2627509|NCT01890109|Secondary|Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) for Erenumab||Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose|All participants who received erenumab and for whom at least 1 pharmacokinetic (PK) parameter or endpoint could be adequately estimated.|||day*μg/mL||Standard Deviation|Mean
2627510|NCT01890109|Secondary|Time to Maximum Observed Concentration (Tmax) of Erunumab After a Single Dose||Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose|All participants who received erenumab and for whom at least 1 pharmacokinetic (PK) parameter or endpoint could be adequately estimated.|||days||Full Range|Median
2627511|NCT01890109|Secondary|Maximum Observed Concentration (Cmax) of Erenumab After a Single Dose|Blood samples were analyzed using an enzyme-linked immunosorbent assay (ELISA) following a validated analytical procedure.|Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose|All participants who received erenumab and for whom at least 1 pharmacokinetic (PK) parameter or endpoint could be adequately estimated.|||μg/mL||Standard Deviation|Mean
2627512|NCT01890109|Secondary|Number of Participants With Treatment-emergent Adverse Events|"A treatment-emergent adverse event is any adverse event that began or worsened after the initial dose of study drug and before the end of study.~A serious adverse event is an adverse event that met at least 1 of the following serious criteria:~fatal~life threatening~required inpatient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~congenital anomaly/birth defect.~other medically important serious event A treatment-related adverse event (TRAE) is any treatment-emergent adverse event that per investigator review had a reasonable possibility of being caused by the study drug."|16 weeks|All participants who received study drug|||Participants|||Count of Participants
2627513|NCT01890109|Secondary|Ratio of Week 4 to Baseline Daily Hot Flash Severity Score|"The daily severity score was calculated according to the following:~(Number of mild hot flashes * 1) + (number of moderate hot flashes * 2) + (number of severe hot flashes * 3).~The baseline daily hot flash severity score is the geometric mean daily hot flash severity score from day -7 to day 1 predose, and the week 4 daily hot flash severity score is the geometric mean daily hot flash severity score from day 21 to day 27.~The ratio of week 4 to baseline (week 4 / baseline) was used to assess change from baseline to week 4 via a log transformation (log[week4/BL] = log[week4] - log[baseline]), which was estimated using a repeated measures analysis. The ratio was obtained via an exponential back-transformation."|Baseline (days -7 to day 1 predose) and week 4 (days 21 to 27)|All participants for whom at least 1 postdose hot flash response measure was recorded.|||ratio||95% Confidence Interval|Number
2627514|NCT01890109|Primary|Ratio of Week 4 to Baseline Average Number of Daily Moderate to Severe Hot Flashes|"The severity of hot flashes was assessed by participants based on the following categories:~Mild: sensation of heat without sweating, mild flushing;~Moderate: sensation of heat, face flushed, slightly clammy, some sweating, able to continue activity, may want to remove layers of clothing or covers at night;~Severe: sensation of heat with more severe sweating, have to stop current activity, may have to change clothing.~Baseline (BL) number of hot flashes is the average number of moderate or severe hot flashes per 24 hours from day -7 to day 1 predose based on geometric mean, and the week 4 number of hot flashes is the average number of moderate or severe hot flashes per 24 hours from day 21 to day 27 based on geometric mean.~The ratio of week 4 to BL was used to assess change from BL to week 4 via a log transformation (log[week4/BL] = log[week4] - log[BL]), which was estimated using a repeated measures analysis. The ratio was obtained via an exponential back-transformation."|Baseline (days -7 to day 1 predose) and week 4 (days 21 to 27)|All participants for whom at least 1 postdose hot flash response measure was recorded.|||ratio||95% Confidence Interval|Number
2637575|NCT01780922|Primary|Superoxide Dismutase (SOD) Activity in Red Blood Cells||0, 2, 4, 8, 24 h||||mU/mg HgB||Standard Error|Mean
2627515|NCT01890031|Secondary|Number of Participants Who Adhered to Medication Prescribed as Self Reported at 9 Months|We will assess adherence (for those who are prescribed a statin in the moderate CVD risk group) by both indirect objective measures and subjective reports. The study design did not include prescription of a cholesterol-lowering medication as per randomization. Participants were prescribed a statin as standard of care based on the participants and physicians agreement. Low risk individuals have less need for medication compared to moderate risk based on the current science.|9 months||||participants|||Number
2627516|NCT01890031|Primary|LDL-C in All ICAT Group Participants Versus Non-ICAT Group Participants||9 months||||mg/dL||Standard Deviation|Mean
2627517|NCT01889862|Other Pre-specified|Protein Intake as Reported by Subjects in Diet Diary|Diet diary collected monthly to assess protein intake from medical food and from natural protein.|Every 4 weeks, throughout study|||||||
2627518|NCT01889862|Secondary|Plasma Phenylalanine (Phe) Levels||Throughout the study|||||||
2627519|NCT01889862|Secondary|Cognitive and Mood Symptoms BMN 165|ADHD-RS IV and the POMS (Profile of Mood States) will be used to evaluate cognitive and mood symptoms.|Throughout the study|||||||
2627520|NCT01889862|Primary|Plasma Phenylalanine (Phe) Levels|Subjects will be assessed every 4 weeks for plasma Phe levels.|Part 2 baseline and Week 8|modified intent to treat (mITT) population (all subjects randomized in Part 2 with a mean blood Phe reduction of ≥20% (using the last two consecutive blood Phe assessments of Part 1) from baseline levels of Study 165-301 or the Phase 2 study in which they initiated BMN 165)|||umol/L||Standard Deviation|Mean
2627521|NCT01889797|Secondary|Progression Free Survival (PFS)|"CT scan every 3 months for 2 years, then every 6 months until progression. Compare PFS in each treatment arm.~Progressive disease (PD) was defined using Cheson criteria as described in the Primary Outcome section above. Progression-free survival (PFS) was defined as the time from start of treatment to the documentation of PD or death, whichever occurs first. Patients alive and without PD were censored at the date of last disease assessment."|Percent of participants alive and progression-free at 1 year||||percentage of participants||80% Confidence Interval|Number
2627522|NCT01889797|Secondary|Overall Response Rate|Overall response rate (CR + PR by Cheson criteria) at re-staging (including bone marrow biopsy if CR suspected) by PET and Neck, Chest, Abdomen and Pelvic Computed Tomography (CT) scan. Patients with unevaluable disease were included in the denominator.|Baseline and Re-staging (week 12, 13 or 14)||||percentage of participants||80% Confidence Interval|Number
2627523|NCT01889797|Secondary|PET Response Rate|PET response rate [PET-documented CR + Partial Response (PR)] based on PET scan results. Patients with unevaluable disease were included in the denominator.|Re-staging (week 12, 13 or 14)||||participants|||Number
2627524|NCT01889797|Primary|Complete Response (CR) Rate|"Positron Emission Tomography (PET)-documented CR rates after induction therapy (weekly treatment x 4 weeks with GA101 or rituximab)~Definitions for clinical response are modified from the Revised Response Criteria for Malignant Lymphoma (Cheson BD, et al. Revised Response Criteria for Malignant Lymphoma. J Clin Oncol 2007; 25(5): 579-86). Lymph node measurements were taken from CT, CT portion of the PET/CT, or MRI scans where applicable. CR is defined as complete disappearance of all evidence of disease; PR as a >50% decrease in the sum of the products of the maximal perpendicular diameters of measured lesions (SPD) and no new sites; SD as failure to attain CR/PR or PD; and PD as any new lesion >1.5cm in any axis or ≥50% increase in previously involved sites."|Re-staging (week 12, 13 or 14) and during follow-up if physician feels patient is subsequently in CR for up to 4 years|All participants were included in the analysis|||percentage of participants||80% Confidence Interval|Number
2627525|NCT01889667|Secondary|The Effect of ORMD-0801 on Morning Fasting C-peptide Compared to Placebo|Difference between concentration of Morning fasting C-peptide of patients on Placebo and concentration of Morning fasting C-peptide of patients on ORMD-0801|Screening, Day 2, Day 9|Modified intention-to-treat (mITT) population consisting of all randomized patients who took at least one dose of study medication and who had at least one night of CGM monitoring|||mg/dL||Standard Deviation|Mean
2627526|NCT01889667|Secondary|The Effect of ORMD-0801 on Morning Fasting Serum Insulin|Difference between concentration of Morning fasting serum insulin of patients on Placebo and concentration of Morning fasting C-peptide of patients on ORMD-0801|Screening, Day 2. Day 9|Modified intention-to-treat (mITT) population consisting of all randomized patients who took at least one dose of study medication and who had at least one night of CGM monitoring|||mg/dL||Standard Deviation|Mean
2627527|NCT01889667|Secondary|The Effect of ORMD-0801 on Mean Daytime Glucose as Measured by Contiuous Glucose Monitoring (CGM)|Difference between concentration of Mean Daytime Glucose of patients on Placebo and concentration of Mean Daytime Glucose of patients on ORMD-0801|Seven (7) days, and last two days (Day 6 and day 7)|Per Protocol (PP) population, consisting of all study completers with an endpoint of adequate weighted mean nighttime glucose and no major protocol violations|||mg/dL||Standard Deviation|Mean
2627528|NCT01889667|Secondary|The Effect of ORMD-0801 on Mean Night Time Glucose as Measured by Contiuous Glucose Monitoring (CGM)|Difference between concentration of Nightime Glucose of patients on Placebo and concentration of Nightime Glucose of patients on ORMD-0801|Seven (7) days, and last two days (Day 6 and day 7)|Per Protocol (PP) population, consisting of all study completers with an endpoint of adequate weighted mean nighttime glucose and no major protocol violations|||mg/DL||Standard Deviation|Mean
2627529|NCT01889667|Primary|Evaluate the Safety and Tolerability of ORMD-0801.|Number of Hypoglycemic events, serious adverse events, and adverse events related to the study drug|Eight (8) days||||Number of Events|||Number
2627530|NCT01889602|Primary|Change From Baseline in Spontaneous Narrative Raw Word Count|Study has 3 arms (100mg, 150mg, or 200mg topiramate) and 3 periods per arm (topiramate, 2mg lorazepam, or placebo). Topiramate (TPM), Lorazepam (LZP), or Placebo (PLA) was given to the participant at the beginning of Sessions 2, 3, and 4 (crossover design). No drug was given at Sessions 1 and 5. The baseline value was defined as the average of the values at Session 1 and Session 5. The change from baseline for Topiramate is the value at 2.5 hours post-dose at the Topiramate visit minus the value at baseline, divided by the value at baseline; similarly for Lorazepam and Placebo.|Session 1 to Session 5||||Word Count||Standard Deviation|Mean
2627603|NCT01888003|Primary|Number of Subjects With Blood Transfusions After Surgery and Prior to Discharge From Hospital|Number of subjects that had at least 1 blood transfusion from the end of surgery until discharge from hospital|post surgery through discharge, an average of 2 days||||participants|||Number
2627531|NCT01889602|Primary|Change From Baseline in COWA Unique Word Count|Study has 3 arms (100mg, 150mg, or 200mg topiramate) and 3 periods per arm (topiramate, 2mg lorazepam, or placebo). Topiramate (TPM), Lorazepam (LZP), or Placebo (PLA) was given to the participant at the beginning of Sessions 2, 3, and 4 (crossover design). No drug was given at Sessions 1 and 5. The baseline value was defined as the average of the values at Session 1 and Session 5. The change from baseline for Topiramate is the value at 2.5 hours post-dose at the Topiramate visit minus the value at baseline, divided by the value at baseline; similarly for Lorazepam and Placebo.|Session 1 to Session 5||||Word Count||Standard Deviation|Mean
2627532|NCT01889563|Secondary|Walking Distance on Six Minute Walking Test|Patients underwent the assessments proposed in the study on an outpatient basis before physical exercise training program and after 6 and 12 weeks of physical exercise training program. The second end-point was walking distance on six minute walking test.|Baseline (before physical exercise training program) and after 6 and 12 weeks of physical exercise training program||||meters||Standard Deviation|Mean
2627533|NCT01889563|Primary|The SD1 Index, a Nonlinear Index of Heart Rate Variability (HRV)That Represents the Parassimpatetic Activity.|Patients underwent the assessments proposed in the study on an outpatient basis before and after 6 and 12 weeks of physical exercise training program. The primary end-point measure was the SD1, a nonlinear index of HRV that represent the parasympathetic modulation|baseline (before physical exercise training program), 6 and 12 weeks after intervention||||miliseconds||Standard Deviation|Mean
2627534|NCT01889420|Secondary|Overall Response Rate (RR)|"ORR is the percentage of patients with a > Partial Response (PR). Response is assessed based on serum protein electrophoresis (SPEP) of the monoclonal protein (M-protein) and plasma concentrations of K/L free light chains (FLC) after each 28-day cycle.~Complete response (CR): disappearance of any M-protein and FLC as measured by SPEP and/or FLC. Pre-existing plasmacytomas must have completely resolved.~PR: >50% reduction in M-protein and >50% reduction in the difference between involved and uninvolved FLC. Any plasmacytoma must have decreased in size by >50%.~Stable disease: not meeting criteria for CR, PR, or progressive disease (PD). PD: >25% increase from baseline in serum or urine M-protein (serum M-protein must increase by > 0.5 gm/dl; urine M-protein must increase by >200 mg /24 hr); or development of new plasmacytomas or new lytic bone lesions; or a measurable increase in the size of these lesions; or hypercalcemia (>11.5 mg/dl) attributed to MM."|3 years|There was only one patient enrolled. Response rates cannot be accurately reported based on one patient.||||||
2627535|NCT01889420|Secondary|Anti-tumor Effect|"Anti-tumor effect will be assessed based on serum protein electrophoresis (SPEP) of the monoclonal protein (M-protein) and plasma concentrations of K/L free light chains (FLC) after each 28-day cycle. Descriptive statistics will be used for this measurement.~Complete response (CR): disappearance of any M-protein and FLC as measured by SPEP and/or FLC. Pre-existing plasmacytomas must have completely resolved.~Partial response (PR): >50% reduction in M-protein and >50% reduction in the difference between involved and uninvolved FLC. Any plasmacytoma must have decreased in size by >50%.~Stable disease: not meeting criteria for CR, PR, or progressive disease (PD). PD: >25% increase from baseline in serum or urine M-protein (serum M-protein must increase by > 0.5 gm/dl; urine M-protein must increase by >200 mg /24 hr); or development of new plasmacytomas or new lytic bone lesions; or a measurable increase in the size of these lesions; or hypercalcemia (>11.5 mg/dl) attributed to MM."|3.5 years|There was only one patient enrolled. Anti-tumor effect cannot be reported accurately based on results from one patient.||||||
2627536|NCT01889420|Secondary|Toxicity Profile|The toxicity profile will be described by specific adverse event rates among patients experiencing > grade 3 hematologic events (lasting >7 days) or grades 3-5 non-hematologic adverse events, according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, over a 28 day cycle. Specific events will be described as the numbers of patients experiencing them within each treatment cohort.|2 years|||||||
2627537|NCT01889420|Primary|Maximum Tolerated Dosage (MTD)(Phase I)|The Maximum Tolerated Dose (MTD) will be determined by first identifying the dose level at which >= 30% of patients experience a Dose Limiting Toxicity (DLT) according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, over a 28 day cycle. DLT will be defined based on the rate of drug-related grade 3-5, non-hematological adverse events experienced within the first 4 weeks (1 cycle) for each combined dosage scheme. The MTD will be defined as one dosage level below which DLT was observed in >= 30% of patients.|2 years|There was only one patient enrolled. The MTD could not be calculated based on one patient.||||||
2627538|NCT01889355|Primary|Enhanced Meter Feature Usability|The primary objective of this study is to evaluate that the intended users are able to obtain accurate blood glucose measurements when operating the blood glucose monitoring system, given only the training materials routinely provided with the system (ISO 15197:2013 8.1).|4 weeks|All diabetic subjects who volunteer for the study and qualify in accordance with the study inclusion and exclusion criteria, the user requirements established by the manufacturer for the blood-glucose system, and applicable regulatory requirements, shall be eligible to participate in the study|||Participants|||Count of Participants
2627539|NCT01889251|Primary|Proportion of Subjects With Non-Surgical Resolution of Vitreomacular Adhesion (VMA)|VMA (adhesion of the vitreous gel to the retina in an abnormally strong manner) was determined by masked Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) evaluation. Only one eye (study eye) was analyzed. Proportion of subjects is reported as a percentage.|Day 28|This analysis population includes all subjects who received study medication, completed at least 1 on-therapy study visit and had symptomatic VMA at baseline, as randomized, based on an intent to treat approach.|||percentage of subjects|||Number
2627540|NCT01889238|Other Pre-specified|Number of Participants With Change From Baseline in Laboratory Parameters Grades by 2 or More Grades|Laboratory tests included hematology parameters (low lymphocytes, WBC, neutrophils, hemoglobin and platelets) and chemistry parameters (mean albumin, Blood urea nitrogen [BUN], calcium, Lactate dehydrogenase [LDH], alanine aminotransferase, Aspartate aminotransferase , bilirubin, Alkaline phosphatase, creatinine and glucose). Number of participants with change from baseline in laboratory parameters Grades by 2 or More Grades as per National Cancer Institute Common Terminology Criteria (NCI CTC) (Grade 0= within normal limits, Grade 1=Mild, Grade 2=Moderate, Grade 3= Severe, Grade 4= Life-threatening) were reported.|Baseline up to 87 weeks|Safety population included all participants who receive 1 dose or partial dose of study drug.|||Participants|||Count of Participants
2628818|NCT01873495|Primary|Assessment of Disease Status|Bone marrow biopsy and aspirate will be obtained.|1 month|Seven patients completed at least one cycle of omacetaxine.|||Participants|||Count of Participants
2627541|NCT01889238|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Criteria: Systolic blood pressure (SBP):absolute SBP<90 millimeters of mercury (mmHg) and decrease from baseline (DFB)>30mmHg, absolute SBP>180mmHg and increase from baseline (IFB)>40 mmHg, final visit or 2 consecutive visits SBP>=20 mmHg change from baseline (CFB), most extreme post-baseline SBP>=140mmHg, most extreme post- baseline SBP>=180mmHg, most extreme SBP>=140mmHg and>=20 mmHg CFB, most extreme SBP>=180mmHg and>=20mmHg CFB; diastolic blood pressure (DBP): absolute DBP>105mmHg and IFB>30mmHg, absolute DBP<50mmHg and DFB>20mmHg, final visit or 2 consecutive visits DBP>=15mmHg CFB, most extreme post-baseline DBP>=90mmHg, most extreme post-baseline DBP>=105mmHg, most extreme DBP>=90mmHg and>=15mmHg CFB, most extreme DBP>=105mmHg and>=15mmHg CFB; heart rate<50beats per minute (BPM) and DFB>20BPM or heart rate>120BPM and IFB>30BPM. Only those categories, in which at least 1 subject had data were reported.|Baseline up to 87 weeks|Safety population included all participants who receive 1 dose or partial dose of study drug.|||Participants|||Count of Participants
2627542|NCT01889238|Other Pre-specified|Number of Participants With Grade 3 or Higher Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. As per the NCI CTCAE, version 4.0, Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death. Only the participants with treatment-emergent AEs of Grade 3 (severe) or higher grade were reported in this outcome measure.|Baseline up to 87 weeks|Safety population included all participants who receive 1 dose or partial dose of study drug.|||Participants|||Count of Participants
2627543|NCT01889238|Other Pre-specified|Number of Participants With Study Drug Discontinuation Due to Adverse Events||Baseline up to 87 weeks|Safety population included all participants who receive 1 dose or partial dose of study drug.|||Participants|||Count of Participants
2627544|NCT01889238|Other Pre-specified|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AEs was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 87 weeks that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.|Baseline up to 87 weeks|Safety population included all participants who receive 1 dose or partial dose of study drug.|||Participants|||Count of Participants
2627545|NCT01889238|Other Pre-specified|Trough Plasma Concentration of Enzalutamide and Its Metabolite,|M2 was the metabolite of enzalutamide. The lower limit of quantitation (LLQ) was 0.0200 micrograms per milliliter (mcg/ml) for enzalutamide and M2.|Predose on Day 1 (Baseline), Week 9 and Week 17|Pharmacokinetics (PK) analysis population included all participants who received 1 dose or partial dose of study drug, and who had at least 1 enzalutamide or M2 plasma concentration assessment.|||mcg/ml||Geometric Coefficient of Variation|Geometric Mean
2627546|NCT01889238|Secondary|Progression-Free Survival: ITT Population|PFS was defined as the time (in weeks) from the date of first dose of study drug to the date of documented disease progression or death due to any cause whichever occurs first as determined by the investigator using RECIST 1.1. As per RECIST 1.1, progression was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.|From Baseline up to disease progression or death due to any cause (up to 87 Weeks)|ITT population included all enrolled participants who had centrally assessed AR+ breast cancer and received at least 1 dose of study drug.|||weeks||85% Confidence Interval|Median
2627547|NCT01889238|Secondary|Progression-Free Survival (PFS): Evaluable Population|PFS was defined as the time (in weeks) from the date of first dose of study drug to the date of documented disease progression or death due to any cause whichever occurs first as determined by the investigator using RECIST 1.1. As per RECIST 1.1, progression was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.|From Baseline up to disease progression or death due to any cause (up to 87 Weeks)|Evaluable population included all enrolled participants who had centrally assessed AR + breast cancer (total nuclear AR expression in >= 10% of tumor cells), had at least 1 dose of study drug and had at least 1 available post baseline tumor assessment evaluable as per RECIST 1.1.|||weeks||85% Confidence Interval|Median
2627548|NCT01889238|Secondary|Percentage of Participants With Best Objective Response: ITT Population|Percentage of participants with best objective response defined as percentage of participants with a best response of CR and PR based on investigator assessment of target, non-target and new lesions using RECIST 1.1. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions.|From Baseline up to disease progression or death due to any cause (up to 87 Weeks)|Analysis was performed on participants from ITT population who had measurable disease.|||percentage of participants||85% Confidence Interval|Number
2627549|NCT01889238|Secondary|Percentage of Participants With Best Objective Response: Evaluable Population|Percentage of participants with best objective response defined as percentage of participants with a best response of CR and PR based on investigator assessment of target, non-target and new lesions using RECIST 1.1. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions.|From Baseline up to disease progression or death due to any cause (up to 87 Weeks)|Analysis was performed on participants from Evaluable population who had measurable disease.|||percentage of participants||85% Confidence Interval|Number
2627743|NCT01885910|Secondary|Percentage of Participants Who Are Responders at Week 16 and 20|Responders is the percentage of participants who have an IGA <3 at Week 16 and 20|Assessed every 4 weeks, reported at weeks 16 and 20||||percentage of participants|||Number
2627550|NCT01889238|Secondary|Percentage of Participants With Clinical Benefit at Week 24: ITT Population|Percentage of participants with a clinical benefit at Week 24 defined as percentage of participants with a best response of CR, PR, or SD for >= 24 weeks on radiologic imaging based on investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.|Week 24|ITT population included all enrolled participants who had centrally assessed AR+ breast cancer and received at least 1 dose of study drug.|||percentage of participants||85% Confidence Interval|Number
2627551|NCT01889238|Secondary|Percentage of Participants With Clinical Benefit at Week 24: Evaluable Population|Percentage of participants with a clinical benefit at Week 24 defined as percentage of participants with a best response of CR, PR, or SD for >= 24 weeks on radiologic imaging based on investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.|Week 24|Evaluable population included all enrolled participants who had centrally assessed AR + breast cancer (total nuclear AR expression in >= 10% of tumor cells), had at least 1 dose of study drug and had at least 1 available post baseline tumor assessment evaluable as per RECIST 1.1.|||percentage of participants||85% Confidence Interval|Number
2627552|NCT01889238|Primary|Percentage of Participants With Clinical Benefit at Week 16: Intent-to-Treat (ITT) Population|Percentage of participants with a clinical benefit at Week 16 defined as percentage of participants with a best response of CR, PR, or SD for >= 16 weeks on radiologic imaging based on Investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference.|Week 16|ITT population included all enrolled participants who had centrally assessed AR+ breast cancer and received at least 1 dose of study drug.|||percentage of participants||85% Confidence Interval|Number
2627553|NCT01889238|Primary|Percentage of Participants With Clinical Benefit at Week 16: Evaluable Population|Percentage of participants with a clinical benefit at Week 16 defined as percentage of participants with a best response of complete response (CR), partial response(PR), stable disease(SD) for >= 16 weeks on radiologic imaging based on Investigator assessment using Response Evaluation Criteria in Solid Tumors version 1.1(RECIST 1.1). An estimate of the percentage and its exact 2-sided 85% confidence interval(CI) were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10mm short axis. PR: At least 30% decrease in sum of longest diameter (LD) of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference|Week 16|Evaluable population included all enrolled participants who had centrally assessed AR + breast cancer (total nuclear AR expression in >= 10% of tumor cells), had at least 1 dose of study drug and had at least 1 available post baseline tumor assessment evaluable as per RECIST 1.1.|||percentage of participants||85% Confidence Interval|Number
2627554|NCT01888965|Secondary|Safety|Percent of subjects who experience grade 3/ 4 adverse events|2 years|Patients had either Stage 4 Colon Cancer, post-metastasectomy; Stage 4 Colon Cancer post-initial chemotherapy; Pancreas Cancer, post-resection and adjuvant chemo; or Locally advanced pancreas cancer post-chemo and radiation.|||percentage of participants|||Number
2627555|NCT01888965|Secondary|Progression-free Survival|"Time in days from study entry until disease progression or death~Disease progression was defined according to RECIST as at least a 20% increase in the sum of the longest diameter of the target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, or the appearance of one or more new lesions"|2 years|Patients had either Stage 4 Colon Cancer, post-metastasectomy; Stage 4 Colon Cancer post-initial chemotherapy; Pancreas Cancer, post-resection and adjuvant chemo; or Locally advanced pancreas cancer post-chemo and radiation.|||days||Full Range|Median
2627556|NCT01888965|Primary|Biomarker Discovery|Changes in biomarkers from before treatment compared to during or after treatment: expression of pFGFR, pFRS2, pERK, BFGF, VEGF, FGFR1, FGFR2,VEGFR, Ki-67, Asp175, and CA9 in tumor tissue; FGFR, VEGFs, BFGF, PLGF, sVEGFR1/ 2, FGF23, GCSF, PDGF-AB, SDF-1a and SCF levels in serum|2 years|Data cannot be summarized in the data table because biomarker analysis did not take place after study closure due to insufficient number of samples to yield significant results related to dovitinib administration. Instead, collected samples are stored in our biobank, as consented by all patients, for future Oncological analyses of importance.||||||
2627557|NCT01888952|Primary|Total Number of Adverse Events.|Adverse events were listed using CTCAE Version 4.03 (Common Terminology Criteria for Adverse Events) toxicity grade.|Average of 21 days.||||Adverse events|||Number
2627558|NCT01888900|Secondary|Rates of Asunaprevir and Daclatasvir Resistance||post treatment||||Participants|||Count of Participants
2627559|NCT01888900|Secondary|Virological Relapse|HCV RNA >= LLOQ level after therapy is stopped in a patient who previously achieved an end-of-treatment virological response|beyond Week 24 post treatment||||Participants|||Count of Participants
2627560|NCT01888900|Secondary|Serum Aminotransferase Levels|whether raw ALT value is in normal range which is less than 41 U/L.|Week 12 post treatment||||Participants|||Count of Participants
2627565|NCT01888900|Primary|Changes in Interferon Stimulated Genes in the Liver|"Change in raw expression in interferon stimulated genes at week 2 or 4 compared to baseline is obtained by subtracting either 2 or 4 week measurement from baseline measurement. Negative values reflect a decrease in expression and positive values reflect an increase in expression.~The raw gene expression data was normalized using quantile normalization based on all the genes in the microarray."|baseline and either 2 or 4 weeks|one patient in genotype 1A arm was not included in primary outcome data collection due to late enrollment.|||relative expression||Inter-Quartile Range|Median
2627566|NCT01888640|Secondary|Moderate Vigorous Physical Activity Minutes Per Day|Accelerometry data classification of physical activity in minutes per day, percent change; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups|Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)||||Minutes per day||95% Confidence Interval|Mean
2627567|NCT01888640|Secondary|Five Time Sit to Stand Test Rate Per 10 Seconds|Time for sit to stand for 5 repetitions converted to a rate of number of sit to stand per 10 seconds; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups|Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)||||sit-to-stand repetitions/10 seconds||95% Confidence Interval|Mean
2627568|NCT01888640|Secondary|Six Minute Walk Test|6MWT - Feet walked as fast as comfortable in six minute; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups|Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)||||Feet||95% Confidence Interval|Mean
2627569|NCT01888640|Secondary|Short Form Survey 36 Physical Component Score (T-score Mean of 50) Higher Scores Indicating Better Health|"Multidimensional self report scale, T score change; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups~The SF36 Physical Functioning Component Score (PCS) quality of life measure. A T-Score of 50 represents the mean, with a standard deviation of 10, values less than 50 indicate a less than average score while values greater than 50 indicate greater than average scores . Higher T-scores reflect better quality of life and lower T-score reflect lesser quality of life ."|Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)||||T-Score||95% Confidence Interval|Mean
2627570|NCT01888640|Secondary|Short Form Survey 36; Mental Component Score (T Score Mean of 50)|"Multidimensional Self Report Questionnaire, T-score; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups~The SF36 Mental Health Component Score (MCS) quality of life measure. A T-Score of 50 represents the mean, with a standard deviation of 10, values less than 50 indicate a less than average score while values greater than 50 indicate greater than average scores . Higher T-scores reflect better quality of life and lower T-score reflect lesser quality of life"|Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)||||T-Score||95% Confidence Interval|Mean
2627571|NCT01888640|Secondary|Tampa Scale of Kinesiophobia (17 to 68 Low to High)|Self report questionnaire with higher scores indicating greater kinesiophobia, score 17-68; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups|Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)||||units on a scale||95% Confidence Interval|Mean
2627572|NCT01888640|Secondary|Brief Pain Inventory, Intensity (0-10 Low to High Scale)|Brief Pain Inventory - Interference, Scale of 0-10 with higher score indicating greater intensity; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups|Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)||||units on a scale||95% Confidence Interval|Mean
2627601|NCT01888367|Primary|Number of Patients With Surgical Site Infections||Within 30 days of surgery|The number of SSIs from the day of surgery to 30 days post-op could only be assessed in the 427 completed patients. Central adjudication by the Clinical Events Committee was not able to assess the presence or absence of SSI for two patients, one in the DFA-02 group and one in the SOC group so the total analyzed is only 425.|||participants|||Number
2627573|NCT01888640|Secondary|Brief Pain Inventory - Interference (0-10 Low to High Scale)|Brief Pain Inventory - Interference; Score 0-10 with higher score indicating greater interference; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups|Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)||||units on a scale||95% Confidence Interval|Mean
2627574|NCT01888640|Secondary|Fibromyalgia Impact Questionnaire Revised - Pain Rating (0-10 Low to High Scale)|numeric rating scale 0 to 10 from the Fibromyalgia Impact Questionnaire Revised: Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups|Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)||||units on a scale||95% Confidence Interval|Mean
2627575|NCT01888640|Secondary|Fibromyalgia Impact Questionnaire Revised|Disease Impact self report Questionnaire, Scoring 0-100; higher score indicates greater disease impact; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups|Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)||||Units on a scale||95% Confidence Interval|Mean
2627576|NCT01888640|Secondary|Resting Fatigue Rating (0-10 Low to High Scale)|Fatigue measured at rest with a 0-10 numeric rating scale; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups|Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)|Baseline, Visit 2 to Visit 3 (4 weeks, randomized to 3 groups) and Visit 4 (4 weeks, all groups home TENS)|||Units on a scale||95% Confidence Interval|Mean
2627577|NCT01888640|Secondary|Fatigue Rating (0-10 Low to High Scale) During Five Time Sit to Stand|Fatigue measured by 0-10 numeric rating scale after five time sit to stand; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups|Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)||||Units on a scale||95% Confidence Interval|Mean
2627578|NCT01888640|Secondary|Fatigue Rating (0-10 Low to High Scale) During Six Minute Walk Test|Fatigue measured with 0-10 numeric rating scale during six minute walk test; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups|Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)||||Units on a scale||95% Confidence Interval|Mean
2627579|NCT01888640|Secondary|Resting Pain (0-10 Low to High Scale)|Numeric rating scale of 0-10 for resting pain; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups|Baseline, Visit 2 to Visit 3 (4 weeks, randomized to 3 groups) and Visit 4 (4 weeks, all groups home TENS)||||units on a scale||95% Confidence Interval|Mean
2627580|NCT01888640|Primary|Pain Rating With Movement (0-10 Low to High Scale) During Five Time Sit to Stand Test|Numeric rating scale of 0-10 for pain with movement with five time sit to stand test. Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups|Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS)||||units on a scale||95% Confidence Interval|Mean
2627581|NCT01888640|Primary|Pain Rating With Movement (0-10 Low to High Scale) During Six Minute Walk Test|Numeric rating scale of 0-10 (low to high scale) for pain with movement during six minute walk test; Intention to treat analysis corrected for site (Iowa and Vanderbilt) differences. Mean change (from baseline, Visit 2) at Visit 3 (after 4 weeks of home TENS use, or placebo TENS, or no TENS) and at Visit 4 (after 4 weeks of home TENS all groups) with 95% adjusted confidence intervals. Change scores are presented for the randomized phase between Visit-2 and Visit-3, and for the difference from baseline at Visit 4 when all subjects received active-TENS. p-values represent post hoc comparisons between groups|Time Frame: Baseline (Visit 2), 4 weeks (Visit 3, randomized to 3 groups), and 8 weeks (Visit 4, all groups home TENS||||Units on a scale||95% Confidence Interval|Mean
2627582|NCT01888432|Secondary|Renal Function by Estimated Glomerular Filtration Rate (All Extension Patients)|Renal function (change in estimated glomerular filtration rate (eGFR)) from randomization to Month 36 post transplantation with everolimus (EVR) in combination with reduced tacrolimus (rTAC) compared to standard exposure tacrolimus (TAC) in living donor liver transplant recipients in Japan|randomization, at 36 months post transplantation|All extension patients consisted of all patients enrolled into this extension study.|||mL/min/1.73m2||Standard Error|Least Squares Mean
2627583|NCT01888432|Secondary|Composite Efficacy Failure of Treated Biopsy in Everolimus With Reduced Tacrolimus Group Compared to Standard Tacrolimus in Patients From Japan Only|"Rate of composite efficacy failure of treated biopsy in everolimus with reduced tacrolimus group compared to standard tacrolimus from randomization in core study up to 36 months in the extension study.~Composite endpoint = treated BPAR, graft loss or death. AR = Acute rejection; tAR = treated AR; BPR = biopsy proven rejection; BPAR = biopsy proven acute rejection; tBPAR = treated BPAR"|randomization, 36 months post transplantion|All extension patients consisted of all patients enrolled into this extension study.|||Participants|||Number
2627584|NCT01888432|Secondary|Compare Incidence of Notable Safety Events (SAEs, Infections and Serious Infections Leading to Premature Discontinuation)|Notable events include death, Serious AE/infection,, and AE/infection leading to discontinuation of study medication.|Month 24|Safety population|||Participants|||Count of Participants
2627585|NCT01888432|Secondary|Number of Subjects Experiencing Adverse Events/Infections by SOC||Month 24|Safety population|||Participants|||Count of Participants
2627586|NCT01888432|Secondary|Number of Participants With Time to Recurrence of HCC in Subjects With a Diagnosis of HCC at the Time of Liver Transplantation|Patients transplanted for HCC or with HCC diagnosed at time of transplantation were monitored for HCC recurrence according to local practice. For example routine laboratory monitoring/tests, tumor markers, hepatic ultrasound, computed tomography scans (CAT, CT) or MRI (especially Fe-MRI) on a regular basis per local practice.|Month 12 and Month 24|Safety population|||Participants|||Count of Participants
2627587|NCT01888432|Secondary|Compare Incidence of tAR|Compare between the treatment group EVR with rTAC vs standard TAC: incidence of treated acute rejection (tAR).|Month 12 and Month 24 post transplantation|FAS|||Participants|||Count of Participants
2627588|NCT01888432|Secondary|Compare Incidence of AR|Compare between the treatment group EVR with rTAC vs standard TAC: incidence of acute rejection (AR)|Month 12 and Month 24 post transplantation|FAS|||Participants|||Count of Participants
2627589|NCT01888432|Secondary|Compare Incidence of Death|Compare between the treatment group EVR with rTAC vs standard TAC: incidence of death|Month 12 and Month 24 post transplantation|FAS|||Participants|||Count of Participants
2627590|NCT01888432|Secondary|Compare Incidence of a Composite of Death or Graft Loss|Compare between the treatment group EVR with rTAC vs standard TAC: Incidence of a composite of death or graft loss|Month 12 and Month 24 post transplantation|FAS|||Participants|||Count of Participants
2627591|NCT01888432|Secondary|Compare Incidence of Graft Loss|Compare between the treatment group EVR with rTAC vs standard TAC: incidence of graft loss|Month 12 and Month 24 post transplantation|FAS|||Participants|||Count of Participants
2627592|NCT01888432|Secondary|Compare Incidence of BPAR|Compare between the treatment group EVR with rTAC vs standard TAC: incidence of a composite of biopsy proven acute rejection (BPAR)|Month 12 and Month 24 post transplantation|FAS|||Participants|||Count of Participants
2627593|NCT01888432|Secondary|Compare Incidence of tBPAR|Compare between the treatment group EVR with rTAC vs standard TAC: Incidence of tBPAR|Month 12 and Month 24 post transplantation|FAS|||Participants|||Count of Participants
2627594|NCT01888432|Secondary|Number of Participants With Composite of tBPAR, Graft Loss, and Death|Compare between the treatment group EVR with rTAC vs standard TAC: incidence of a composite of tBPAR, graft loss, death|Month 24 post transplantation|FAS|||Participants|||Count of Participants
2627595|NCT01888432|Secondary|Compare Renal Function Over Time Assessed by the Change by eGFR, Post-randomization|Change in renal function from randomization to month 24 assessed by the change in estimated GFR (MDRD-4). Rate of change of renal function.|From randomziation to month 24|FAS|||mL/min/1.73 m2||Standard Error|Least Squares Mean
2627596|NCT01888432|Secondary|Renal Function by Estimated Glomerular Filtration Rate (eGFR) From Randomization|Renal function (change in estimated glomerular filtration rate (eGFR)) from randomization to Month 12 post transplantation with everolimus (EVR) in combination with reduced tacrolimus (rTAC) compared to standard exposure tacrolimus (TAC) in living donor liver transplant recipients.|From randomization to month 12|FAS|||mL/min/1.73 m^2||Standard Error|Least Squares Mean
2627597|NCT01888432|Primary|Number of Participants With Composite Efficacy Failure of Treated Biopsy Proven Acute Rejection, Graft Loss or Death in Everolimus With Reduced Tacrolimus Group Compared to Standard Tacrolimus|Rate of composite efficacy failure of treated biopsy proven acute rejection (tBPAR ≥ RAI score 3), graft loss (GL) or death (D) in everolimus with reduced tacrolimus group compared to standard tacrolimus at 12 months|12 months post transplantation|FAS|||Participants|||Count of Participants
2627598|NCT01888367|Secondary|Cumulative ASEPSIS Score for Each Patient|Total ASEPSIS score with a range of 0-65 points with lower scores being better. The score is the sum of: Antibiotic Use (10 points), Drainage of Pus Under Local Anesthesia (5 points), Debridement Under General Anesthesia (10 points), Serous Discharge (5 points), Erythema (5 points), Purulent Exudate (5 points), Separation of Deep Tissues (10 points) and Isolation of Bacteria from Discharge (10 points). Source: Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. Lancet. 1986:1(8476):311-3.|Through post-operative Day 4|"Safety analyses were as treated so patients who were randomized to gel but did not receive it are counted as SOC. For 4 patients, the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized."|||units on a scale||Standard Deviation|Mean
2627599|NCT01888367|Secondary|Change in Serum Creatinine Measurements From Baseline|Change from baseline in micromoles/liter|Within 4 days of surgery|"402 of the 445 patients had both baseline and post-operative creatinine measurements. Safety analyses were as treated so patients randomized to gel but did not receive it in surgery were counted in the SOC group."|||micromoles/liter||Standard Deviation|Mean
2627602|NCT01888003|Primary|Number of Subjects Requiring Blood Transfusions Post Hospital Discharge Through 90 Days After Surgery|number of subjects requiring blood transfusions after hospital discharge through 90 days after surgery|post hospital discharge through 90 days after surgery|Subjects dropped out of study prior to day 90||||||
2627604|NCT01888003|Secondary|Health-related Quality of Life|Health-related quality of life measured with the SF-12V2; Western Ontario and McMaster University Osteoarthritis Index (WOMAC) Questionnaire; Oxford Hip Score or Oxford Knee Score; and Multidimensional Assessment of Fatigue (MAF) Scale|Baseline at 14 days before, on hospital discharge, and at two-weeks, 30 days, 60 days and 90 days after surgery|No subject data was analyzed.||||||
2627605|NCT01888003|Primary|Number of Subjects Requiring at Least One Blood Transfusion During Surgery.|The number of subjects who had blood transfusions (at least 1) during surgery|During surgery (less than 1 day)||||Participants|||Number
2627606|NCT01887990|Secondary|Depression|Scales and Questionnaire using the MADRS (Montgomery-Asberg Depression Rating Scale) . This is a ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. the scale: 0 - 6 (normal/symptom absent), 7 - 19 (mild depression), 20 - 34 (moderate depression), and > 34 (severe depression).The overall score ranges from 0 to 60|2 hours||||units on a scale||Standard Deviation|Mean
2627607|NCT01887990|Primary|Suicidality|"Scales and questionnaires using the Beck Scale for Suicidal Ideation. The Beck Scale is a self-report questionnaire. The items on this scale identify the presence and severity of suicidal ideation.~Beck Scale for Suicidal Ideation has 19 items,preceded by a 5 item screener. Each item is rated on a 3 point scale from 0 to 2. Scores range from 0 to 48. Total scoreScores of 0 - 16 indicate low risk for suicide; scores of 16 or greater indicate higher risk for suicide."|2 hours||||units on a scale||Standard Deviation|Mean
2627608|NCT01887912|Secondary|Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions|Solicited injection site reactions: pain, erythema, and swelling. Pain: Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity; Erythema and swelling: Grade 1: >= 25 to <=50 mm, Grade 2: >51 to <=100 mm, Grade 3: >100 mm. Solicited systemic reactions: fever, headache, malaise, myalgia, and arthralgia. Fever: Grade 1: >= 38.0°C to <=38.4°C or >= 100.4° Fahrenheit (F) to <=101.1°F, Grade 2: >=38.5°C to <= 38.9°C or >=101.2°F to <=102.0°F, Grade 3: >=39.0°C or >=102.1°F. Headache, malaise, and myalgia: Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity; Arthralgia: Grade 1: free range of motion but complains of pain or discomfort, Grade 2: decreased range of motion due to pain or discomfort, Grade 3: unwilling to move due to pain.|Day 0 to Day 6 after any vaccination|Analysis was performed on all participants who received vaccine and were evaluable for reactogenicity. Here, ‘number analyzed’ = participants with available data for each specified category.|||percentage of participants|||Number
2627609|NCT01887912|Secondary|Serum Antibody Concentrations Against Toxins A and B Measured by TNA in Participants With CDI|Serum antibody concentrations against toxins A and B were measured by TNA and were expressed as GMT. The 2-sided 95% CI GMC was based on the Student t-distribution. Symptomatic PCR confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: >= 3 loose stools in <= 24 hours, loose stools (defined as type 6 [fluffy pieces with ragged edges, mushy] or type 7 [watery, no solid pieces] according to the Bristol Stool Chart) lasting >= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.|Day 0 and Day 60|Analysis was performed on participants with protocol-defined (PCR confirmed) primary CDI cases. Here, ‘number analyzed’ = participants with available data for each specified category.|||Titer (1/dilution)||95% Confidence Interval|Geometric Mean
2627610|NCT01887912|Secondary|Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by TNA|Percentage of Participants with >= 2 and 4-fold rise in serum antibody concentrations against toxins A and B were measured by TNA. The 2-sided 95% CI of the percentage was based on Exact method calculations.|Day 60|"Analysis was performed on Per Protocol Immunogenicity Analysis Set. Here, overall number of participants analyzed signifies participants evaluable for this outcome measure and 'number analyzed' = participants with evaluable data for each specified category."|||percentage of participants||95% Confidence Interval|Number
2627611|NCT01887912|Secondary|Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)|Serum antibody concentrations against toxins A and B were measured by TNA and expressed as geometric mean titer (GMT). The 2-sided 95% Cl of GMT was based on the Student t-distribution.|Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110|Analysis was performed on Per Protocol Immunogenicity Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.|||Titer (1/dilution)||95% Confidence Interval|Geometric Mean
2627612|NCT01887912|Secondary|Serum Antibody Concentrations Against Toxins A and B Measured by ELISA in Participants With CDI|Serum antibody concentrations against toxins A and B were measured by ELISA and expressed as GMC. The 2-sided 95% CI GMC was based on the Student t-distribution. Symptomatic PCR-confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: >= 3 loose stools in <= 24 hours, loose stools (defined as type 6 [fluffy pieces with ragged edges, mushy] or type 7 [watery, no solid pieces] according to the Bristol Stool Chart) lasting >= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.|Day 0 and Day 60|Analysis was performed on participants with protocol-defined (PCR confirmed) primary CDI cases. Here, ‘number analyzed’ = participants with available data for each specified category.|||EU/mL||95% Confidence Interval|Geometric Mean
2627613|NCT01887912|Secondary|Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by ELISA|Percentage of Participants with >= 2 and 4-fold rise in serum antibody concentrations against toxins A and B were measured by ELISA. The 2-sided 95% Cl of the percentage was based on Exact method calculations.|Day 60|Analysis was performed on Per Protocol Immunogenicity Analysis Set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.|||percentage of participants||95% Confidence Interval|Number
2627663|NCT01887327|Secondary|Number of Participants With Rebound Hyperbilirubinemia|Rebound hyperbilirubinaemia was defined as an increase in TSB above the age-specific threshold for initiating phototherapy, following the discontinuation of the initial phototherapy.|within 54 hours|Intention to treat|||Participants|||Count of Participants
2672097|NCT01472549|Secondary|Number of Participants With Endometritis||30 days||||Participants|||Count of Participants
2627614|NCT01887912|Secondary|Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)|Serum antibody concentrations against toxins A and B were measured by ELISA and expressed as geometric mean concentration (GMC). The 2-sided 95% Confidence Interval (CI) of GMC was based on the Student t-distribution. Analysis was performed on Per Protocol Immunogenicity Analysis Set, which included participants who had at least 1 injection, no relevant protocol deviations (not met inclusion criteria/ met exclusion criteria, not received vaccine/ not received in proper time window, received different vaccine than randomized, preparation and/ or administration of vaccine not per protocol, protocol-restricted therapy, not provided post-dose serology sample/serology sample did not produced a valid test result).|Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110|Analysis was performed on Per Protocol Immunogenicity Analysis Set. Here, ‘number analyzed’ = participants with available data for each specified category.|||ELISA units per milliliter (EU/mL)||95% Confidence Interval|Geometric Mean
2627615|NCT01887912|Secondary|Number of Participants With Symptomatic PCR Confirmed CDI Cases: Per-Protocol Population|Symptomatic PCR confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: >= 3 loose stools in <= 24 hours, loose stools (defined as type 6 [fluffy pieces with ragged edges, mushy] or type 7 [watery, no solid pieces] according to the Bristol Stool Chart) lasting >= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy. Analysis was performed on per-protocol efficacy analysis set (PPEAS).|Up to 3 years post injection 1|PPEAS: participants who had at least 1 injection, no relevant protocol deviations (not meet inclusion criteria/ met exclusion criteria, not receive any vaccine/not received in proper time window, received different vaccine than randomized, preparation and / or administration of vaccine not done per protocol, received protocol-restricted therapy).|||Participants|||Count of Participants
2627616|NCT01887912|Secondary|Number of Participants With Loose Stool Episodes|Loose stools were defined as type 6 (fluffy pieces with ragged edges, mushy) or type 7 (watery, no solid pieces) according to the Bristol Stool Chart. In this outcome measure, participants with number of loose stool episodes (categorized as: loose stool episodes less than 3, 3 to 6, 7 to 10, 11 to 15 and greater than 15) were reported.|Up to 3 years post injection 1|Analysis was performed on participants with protocol-defined PCR confirmed CDI cases.|||Participants|||Count of Participants
2627617|NCT01887912|Secondary|Number of Participants With Severe PCR-Confirmed Primary CDI Cases|Severe CDI cases were defined as number of participants with at least one of the following symptoms: fever >= 38.5 degree Celsius (°C), white blood cell count >= 15,000 cells/mm^3, ileus, pseudomembranous colitis, serum albumin <3 gram per deciliter, abdominal distension, abdominal tenderness, or admission to the intensive care unit within 7 days of CDI diagnosis.|Up to 3 years post injection 1|Analysis was performed on participants with protocol-defined (PCR confirmed) primary CDI cases.|||Participants|||Count of Participants
2627618|NCT01887912|Primary|Number of Participants With Symptomatic Polymerase Chain Reaction (PCR)-Confirmed Primary C. Difficile Infection (CDI) Cases|Symptomatic PCR-confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: >= 3 loose stools in <= 24 hours, loose stools (defined as type 6 [fluffy pieces with ragged edges, mushy] or type 7 [watery, no solid pieces] according to the Bristol Stool Chart) lasting >= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.|Up to 3 years post injection 1|Analysis was performed on modified intent-to-treat (mITT) population which included all participants who received at least 1 injection and were analyzed according to the group to which they were randomized.|||Participants|||Count of Participants
2627619|NCT01887717|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|An TEAE is any untoward medical occurrence or undesirable event(s) experienced in a participant that begins or worsens following administration of the study drug or study treatment, whether or not considered related to the treatment by the Investigator. A serious adverse event (SAE) was an adverse event (AE) resulting in any of the following outcomes or deemed significant for any other reason, death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or congenital anomaly. AEs included both SAEs and non-serious AEs. AEs were classified according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 (CTCAE) and coded using the Medical Dictionary for Regulatory Activities (MedDRA). A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Randomization up to participant's death (maximum time = up to Month 30)|Participants who received at least 1 dose of TheraSphere or Sorafenib.|||Participants|||Count of Participants
2627620|NCT01887717|Secondary|Time to Deterioration QoL (TTDQoL)|TTDQoL was calculated as the interval between the randomization date and deterioration in QoL. The FACT-Hep Questionnaire uses PRO scores. A deterioration in QoL is defined as a >7-point decline in the total score or death, whichever occurred first. The FACT-Hep Total Score is the sum of the subscales scores in PWB, Social/Family Well-Being (SWB), Emotional Well-Being (EWB), FWB, and HCS. The higher the score, the better the QoL, with a range 0-180. TTDQoL (Months)=(Date of change from baseline in FACT-Hep ≥7 or death) - Date of Randomization + 1.|Baseline (Randomization) up to participant's death (maximum time = up to Month 30)|Participants who received at least 1 dose of TheraSphere or Sorafenib.|||months||Full Range|Mean
2627621|NCT01887717|Secondary|Change From Baseline in Quality of Life (QoL) as Assessed by the FACT-Hep Questionnaire|The Functional Assessment Cancer of Therapy-Hepatobiliary (FACT-Hep) Questionnaire uses participant reported outcome (PRO) scores. The FACT-Hep Trial Outcome Index (TOI) is the sum of the subscales scores in Personal Well-Being (PWB), Functional Well-Being (FWB), and Hepatobiliary Cancer Subscale (HCS). The higher the score, the better the QoL, with a range 0-128. Baseline data and change from Baseline data is presented.|Baseline (Randomization), participant's death (maximum time = up to Month 30)|Participants who received at least 1 dose of TheraSphere or Sorafenib and with evaluable TOI data.|||score on a scale||Standard Deviation|Mean
2627664|NCT01887327|Secondary|Number of Participants With Phototherapy (PT) Failure|"PT failure was defined by any of the following:~re-start of PT within 6 hours after stopping~re-hospitalization for hyperbilirubinaemia~use of intravenous immunoglobulin (IVIg)~need for an exchange transfusion"|within 30 days after discharge|Intention to treat|||Participants|||Count of Participants
2627622|NCT01887717|Secondary|Number of Participants With Tumor Response|Tumor Response was based on the radiological tumor assessment and was categorized as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). Tumor response was assessed using RECIST version (v) 1.1, mRECIST, and EASL criteria. Criteria included: CR=disappearance of all enhanced tumor areas (EASL) and disappearance of any intratumoral arterial enhancement in all target lesions (mRECIST); PR= decrease >50% of enhanced areas (EASL) and ≥30% decrease in the sum of diameters of viable target lesions (mRECIST); SD=neither CR, PR, PD (EASL/mRECIST); PD=an increase >25% in the size of ≥1 measurable lesions (EASL) and ≥20% increase in the sum of the diameter of viable of target lesion (mRECIST). RECIST v 1.1 categorized new lesions as Progressive Disease only and the non-target lesions needed to have no progressive disease to be categorized as CR or PR. One month=30.4375 days.|Baseline up to participant's death (maximum time = up to Month 30)|Participants who received at least 1 dose of TheraSphere or Sorafenib and with available Tumor Response data.|||Participants|||Count of Participants
2627623|NCT01887717|Secondary|Time to Symptomatic Progression (TTSP)|TTSP calculated as interval between randomization and symptomatic progression. Symptomatic progression defined as clinical progress to Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥2 with or without tumor progression on imaging. Deterioration in PS was confirmed at the evaluation 8 weeks later. First date at which ECOG performance status was ≥2 was used as end date in TTSP analysis (assuming next subsequent visit confirmed deterioration). TTSP (Months)=(Date of ECOG >2-Date of Randomization+1)/30.4375. ECOG PS Scale: 0=Asymptomatic and fully active; 1=Symptomatic, fully ambulatory, restricted in physically strenuous activity; 2=Symptomatic, ambulatory, capable of self-care, more than 50% of waking hours are spent out of bed; 4=Completely disabled, no self-care, bedridden. Median time to event defined as time it is expected for half of the participants to experience the event. Data analyzed using the Kaplan-Meier method.|Randomization up to participant's death (maximum time = up to Month 30)|Participants who received at least 1 dose of TheraSphere or Sorafenib.|||months||Full Range|Median
2627624|NCT01887717|Secondary|Time to Worsening Portal Vein Thrombosis (PVT)|Time of randomization to time of any change in classification of PVT type by ≥1 sub-type based on Investigator assessment. At screening and every 8 weeks after, PVT categorized based on dynamic imaging studies as: Type I: segmental, in ≥1 of 8 branches of the portal vein; Type II: branched, left or right branches of the portal vein; Type III: modified on the basis of extension of the tumor thrombus; Type IIIa: eligible for study, thrombus involving the main trunk, allowing blood flow to contralateral lobe (no thrombosis); Type IIIb: NOT eligible for study, thrombus in the main portal trunk occluding blood flow to contralateral lobe; and Type IV: main PVT, NOT eligible for study, extended (mesenteric or splenic veins and/or sovra-hepatic veins). Time to Worsening of PVT (Months)=(Date of event/censor-Date of Randomization+1)/30.4375. Median time to event defined as time it is expected for half of the participants to experience the event. Data analyzed using the Kaplan-Meier method.|Baseline (Randomization) up to participant's death (maximum time = up to Month 30)|Participants who received at least 1 dose of TheraSphere or Sorafenib.|||months||95% Confidence Interval|Median
2627625|NCT01887717|Secondary|Time to Progression (TTP)|TTP was defined as the time from randomization until date of first radiological progression (including new liver lesions and extra-hepatic lesions) separately according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 criteria, modified RECIST (mRECIST) criteria, and European Association for the Study of the Liver (EASL) criteria (assessed bi-dimensionally on enhancing tissue) as assessed by Investigator determination. Progression was defined as an increase >25% in the size of ≥1 measurable lesions (EASL) and ≥20% increase in the sum of the diameter of viable of target lesion (mRECIST). RECIST v1.1 categorized new lesions as Progressive Disease. TTP (Months)=(Date of event/censor - Date of Randomization + 1)/ 30.4375.|Randomization up to participant's death (maximum time = up to Month 30)|Participants who received at least 1 dose of TheraSphere or Sorafenib.|||months||Full Range|Median
2627626|NCT01887717|Primary|Overall Survival (OS) From Time of Randomization|OS was calculated as the interval between the randomization date and the date of death for any cause, with censoring at the date of last contact for participants alive.|Randomization up to participant's death (maximum time = up to Month 30)|Participants who received at least 1 dose of TheraSphere or Sorafenib.|||months||Full Range|Median
2627627|NCT01887678|Secondary|Time to and Use of Rescue Medication (Acetaminophen up to 3000 mg Per Day for Breakthrough Pain) (Study Population Measure Statistically Derived). Tablets Taken.|Time to and use of rescue medication (acetaminophen up to 3000 mg per day for breakthrough pain) (study population measure statistically derived). Total number of tablets taken as reported by patient.|Statistically derived|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||Tablets||Standard Deviation|Mean
2627628|NCT01887678|Secondary|Time to and Use of Rescue Medication (Acetaminophen up to 3000 mg Per Day for Breakthrough Pain) (Study Population Measure Statistically Derived) - Patients Use|Time to and use of rescue medication (acetaminophen up to 3000 mg per day for breakthrough pain) as reported by the patients. Patients who used any rescue medication during the study.|Statistically derived|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||participants|||Number
2627629|NCT01887678|Secondary|Patients Achieving 100% Pain Relief|Changes of the target (treated) knee pain following a 50 feet walk self-assessed by the patients on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. The time to 100% pain relief were statistical exercises and were analyzed for each individual patient from their self-assessment, however, the prevalence of 100% pain relief did not support an estimate for the median time. The number of patients who reached 100% pain relief is reported and the log rank test for difference in time to 100% pain relief was calculated for each injection.|Statistically derived|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||participants|||Number
2627630|NCT01887678|Secondary|Time to 50% Pain Relief (Study Population Measure Statistically Derived)|Changes of the target (treated) knee pain following a 50 feet walk self-assessed by the patients on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. The time to 50% pain relief were statistical exercises and were analyzed for each individual patient from their self-assessment.|Statistically derived|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||days||95% Confidence Interval|Median
2627631|NCT01887678|Other Pre-specified|Proportion of Patients Who Discontinued Due to an AE|Total number of patients affected.|All visits (Days 1 up to 119)|119 patients were randomized to Traumeel/Zeel and 113 patients to Placebo and all randomized patients were included in the Safety Set. Medical Dictionary for Regulatory Activities (MedDRA) Version 16.0 terminology.|||participants|||Number
2627632|NCT01887678|Other Pre-specified|Incidence of Treatment Emergent Adverse Events (TEAEs)|Total number of patients affected.|during the treatment period and follow up period (Days 11 to 119)|119 patients were randomized to Traumeel/Zeel and 113 patients to Placebo and all randomized patients were included in the Safety Set. MedDRA Version 16.0 terminology. Adverse events during treatment (treatment-emergent) in 5% or more of total study patients|||participants|||Number
2627633|NCT01887678|Other Pre-specified|Each Adverse Event (AE)|Total number of patients affected.|Starting at Visit 2/ Start of Lead-In period (Day 7 up to day 119)|119 patients were randomized to Traumeel/Zeel and 113 patients to Placebo and all randomized patients were included in the Safety Set. 8 patients without any injection (not randomized) reported 12 adverse events|||participants|||Number
2627634|NCT01887678|Other Pre-specified|Serious Adverse Events|Total number of patients affected.|Start of Lead-In period until individual study end, up to 16 weeks.|119 patients were randomized to Traumeel/Zeel and 113 patients to Placebo and all randomized patients were included in the Safety Set. MedDRA Version 16.0 terminology|||participants|||Number
2627635|NCT01887678|Secondary|Time to Walking (50-foot Walk Test)|Changes in time to walk 50 feet (seconds)|Baseline (Day 1, predose) to post-Baseline visits (up to day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||seconds||Standard Deviation|Mean
2627636|NCT01887678|Secondary|Pain Immediately Following the 50-foot Walk (100 mm VAS)|Changes of the target (treated) knee pain following a 50 feet walk self-assessed by the patients on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'.|Baseline (Day 1, predose) to post-Baseline visits (up to day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||units on a scale||Standard Deviation|Mean
2627637|NCT01887678|Secondary|Physician Global Assessment (PhGA)|"Study Physicians made an overall Global Assessment of the knee osteoarthritis with the assessment stages Very good, Good, Fair, Poor and Very poor."|End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||participants|||Number
2627638|NCT01887678|Secondary|Physician Global Assessment (PhGA)|"Study Physicians made an overall Global Assessment of the knee osteoarthritis with the assessment stages Very good, Good, Fair, Poor and Very poor."|Baseline (Day 1, predose)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||participants|||Number
2627639|NCT01887678|Secondary|Patient Global Assessment (PGA)|"Patients made an overall Global Assessment of the knee osteoarthritis with the assessment stages Very good, Good, Fair, Poor and Very poor."|End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||participants|||Number
2627640|NCT01887678|Secondary|Patient Global Assessment (PGA)|"Patients made an overall Global Assessment of the knee osteoarthritis with the assessment stages Very good, Good, Fair, Poor and Very poor."|from Baseline (Day 1, predose)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||participants|||Number
2627641|NCT01887678|Secondary|Total WOMAC Score (All Subscales) Recorded on 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. A total WOMAC score was computed by averaging all 24 possible responses. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in total WOMAC score were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.|from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||units on a scale||Standard Deviation|Mean
2627744|NCT01885910|Secondary|Inflammatory and Non-inflammatory Lesion Counts||Every 4 weeks|participants with data|||lesions||Standard Deviation|Mean
2627642|NCT01887678|Secondary|Physical Function Bubscore (WOMAC Section C, Items #8-24) Recorded on 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. To assess physical function, scores from WOMAC Section C, items 8 to 24 are averaged to yield the Physical Function Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in Physical Function subscore were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.|from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||units on a scale||Standard Deviation|Mean
2627643|NCT01887678|Secondary|Stiffness Subscore (WOMAC Section B, Items #6-7) Measured by 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. To assess stiffness, scores from WOMAC Section B, items 6 to 7 are averaged to yield the Stiffness Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in stiffness score were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.|from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||units on a scale||Standard Deviation|Mean
2627644|NCT01887678|Secondary|Pain Subscore (WOMAC Section A, Items #1-5) Measured by 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. To assess pain, scores from WOMAC Section A, items 1 to 5 are averaged to yield the Pain Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. Changes in pain subscore were analyzed by using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and Baseline value as a covariate.|from Baseline to post-Baseline visits except End of Study Visit (up to day 105)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||units on a scale||Standard Deviation|Mean
2627645|NCT01887678|Primary|Change in Knee Pain as Measured by the WOMAC Osteoarthritis (OA) Index Pain Subscale (Section A, Items #1-5) Measured by 100 mm VAS|Changes of the target (treated) knee were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index version 3.1 (WOMAC OA) whereby patients self-assessed 24 parameters on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0 corresponded to 'None' and 100 to 'Extreme'. To assess pain, scores from WOMAC Section A, items 1 to 5 are averaged to yield the Pain Subscale total score. At Study Days 1, 8 and 15 where injections were administered, this was to be done before injection. A two-sided test of equality of the study drug (Traumeel®-Zeel®) and Placebo at level 0.05 was computed using an analysis of covariance (ANCOVA) model with treatment group as qualitative factor and the corresponding Baseline value of the primary efficacy variable as a covariate. The test decision was based on the (two-sided) p-value for the corresponding test of no treatment difference.|from Baseline (Day 1, predose) to End of Study Visit (up to Day 119)|119 patients were randomized to Traumeel/Zeel and 113 to Placebo and all were included in the Safety Set. Two patients in each group could not be evaluated for primary efficacy. 117 patients in Traumeel/Zeel and 111 patients in Placebo formed the Full Analysis - efficacy. For missing values, Last-observation carried forward (LOCF) was used.|||units on a scale||Standard Deviation|Mean
2627646|NCT01887587|Primary|Optimal Dose of MLN9708|This measure will be the maximum tolerated dose (MTD) at which no more than 1 Dose Limiting Toxicity (DLT) is observed. The starting dose of MLN9708 will be 2.3 mg orally on days 1, 8 and 15. If no DLT is seen in the first 3 patients, the dose will be increased to 3 mg and then to 4 mg orally on days 1, 8 and 15 in a classic 3 +3 phase I design. We will not attempt to increase the dose beyond 4 mg orally which, if achieved with acceptable toxicity, would be accepted as the recommended phase 2 dose (RP2D). 0 of 3 DLTs would allow escalation to the next dose level. 1 of 3 DLTs will require expanding to six patients; 1 of 6 DLTs will allow escalation again. 2 DLTs will require dose de-escalation.|8 Weeks|All five subjects received the same 2.3 mg oral dose of MLN9708.|||mg|||Number
2627647|NCT01887587|Primary|Adverse Events.|Safety, tolerability will be assessed by counting the number of participants experiencing adverse events at 8 weeks post treatment.|Baseline to 30 days post treatment; approximately 8 weeks|At dose level one, 3 patients who were enrolled. The protocol was amended to remove PEGaspargase from the regimen. Two additional patients were enrolled on dose level one.|||participants|||Number
2627648|NCT01887470|Secondary|Colonic Methane Gas Levels||3 - 15 hours post last consumption|A secondary objective in the protocol called for colonic gas levels to be measured for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.|||parts per million by volume||Full Range|Mean
2627649|NCT01887470|Secondary|Colonic Hydrogen Gas Levels||3 - 15 hours post last consumption|A secondary objective in the protocol called for colonic gas levels to be measured for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.|||parts per million by volume||Standard Deviation|Mean
2627665|NCT01887327|Secondary|Time (Hour) at Which TSB First Crosses at or Below the Defined Age-specific Threshold for 54-hours Post-treatment (PT)|The hour that 50% of babies in the group (median) first crosses at or below the defined 54-hour threshold for the baby's age|within 54 hours|ITT Analysis Set minus 2 participants who received placebo and did not reach the defined threshold for their age within 54 hours|||hours||Full Range|Median
2627650|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant|"Survey response to question: if you had a previous colonoscopy, please indicate your preference for the crystalline lactulose or the previous medications."|3 to 15 hours post last consumption|Of the 40 participants responding to the patient questionnaire, only 21 reported that they had had a previous colonoscopy; therefore, the other 19 are not included in this outcome measure.|||percentage of participants|||Number
2627651|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant|"Survey response to question: Would you be willing to repeat this preparation if a colonoscopy was felt to be medically necessary at some point in the future? The outcome measure is reporting the percentage of participants who replied Yes to this survey question."|3 - 15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.|||Percentage of Participants|||Number
2627652|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 3|"Tolerability assessed by a patient questionnaire - Likert response to The dosing instructions were easy to understand and follow Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree"|3 - 15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.|||units on Likert Scale||Standard Deviation|Mean
2627653|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 2|"Tolerability assessed by a patient questionnaire - Likert response to I did not experience too much discomfort during the bowel prep Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree"|3-15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.|||units on Likert Scale||Standard Deviation|Mean
2627654|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 1|"Tolerability assessed by a patient questionnaire - Likert response to was regimen a tolerable bowel prep? Range of responses allowed include whole numbers between 1 and 7. The following guide was given to the patients: 1 = Strongly Disagree; 4 = Neutral; 7 = Strongly Agree"|3-15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.|||units on Likert Scale||Standard Deviation|Mean
2627655|NCT01887470|Secondary|Tolerability of and Preference for Lactulose as a Bowel Evacuant-Patient Visual Analog Scale (VAS)|"A paper questionnaire contained a horizontal line 100 mm long with the right end labeled Best Possible Experience and the left end labeled Worst Possible Experience. The patients were asked to use a pen to place a mark on the line at the point that best described their overall tolerability for the bowel preparation.~Scores were determined by measuring the distance of the mark from the left end of the line. So, a lower number would indicate a poor experience and a high number would reflect a positive experience, with 100 being the maximum score and one that describes the best possible experience with the preparation."|3 - 15 hours post last consumption|The study objectives in the protocol called for patient tolerability to be evaluated for all treatment participants. Therefore, outcome measures are not displayed with respect to the four individual treatment groups.|||units on VAS scale||Standard Deviation|Mean
2627656|NCT01887470|Secondary|Incidence of Treatment Failure|A treatment failure is defined in the protocol as a bowel preparation that receives a cumulative Boston Bowel Preparation Score less than 5, or has one or more of the segments scored as a 0.|at least 3 hours post last consumption|The study objectives in the protocol called for the incidence of treatment failures to be calculated from the pooled data of all treatment participants. Therefore, outcome measures are not displayed with respect to individual treatment groups.|||participants|||Number
2627657|NCT01887470|Primary|Efficacy of Lactulose as a Preparation for Colonoscopy.|"Efficacy assessed by the physician's determination of the cleanliness of the colon using the cumulative Boston Bowel Preparation Scale (BBPS) score. The cumulative score is derived from three segmental scores assessed from the following three colonic segments: right colon, transverse colon, and left colon. Segment scores range from 0 to 3 with the following abbreviated definitions: 0=mucosa not visible; 1=a portion of the mucosa is visible; 2=minor residue, but mucosa is seen well; 3=entire mucosa is seen well with no residue.~The cumulative BBPS score is the sum of the three segment scores such that a cumulative score of 9 represents a colon with maximum mucosa visible and a score of 0 represents minimal visibility."|at least 3 hours post last consumption||||units on a scale||Standard Deviation|Mean
2627658|NCT01887418|Primary|The Average Concentration [Cavg] of Testosterone Enanthate Formulations at 6 Weeks|The average concentration [Cavg] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks|PK profile of TT obtained at Week 6 of treatment by QST|||ng/dL||Standard Deviation|Mean
2627659|NCT01887418|Primary|The Maximum Plasma Concentration [Cmax] of Testosterone Enanthate Formulations at 6 Weeks|The maximum observed plasma concentration [Cmax] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks|PK profile of TT obtained at Week 6 of treatment by QST|||ng/dL||Standard Deviation|Mean
2627660|NCT01887418|Primary|The Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of Testosterone Enanthate Formulations at 6 Weeks|The area under the curve from time zero to last quantifiable concentration [AUC (0-t)] of TE administered by SC injection once weekly at doses of 50 mg and 100 mg via the QST|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post-dose, at 6 Weeks|PK profile of TT obtained at Week 6 of treatment by QST|||ng*hr/dL||Standard Deviation|Mean
2627661|NCT01887418|Secondary|Number of Patients in the PK Parameter Category|The number of TT Cavg (0-168h) values within the normal range (300-1100 ng/dL) following treatment with SC TE administered via QST or IM TE|6 weeks||||participants|||Number
2627662|NCT01887353|Primary|Time to First Atrial Fibrillation (AF) Recurrence|There were too few participants for an assessment of time to first recurrence, therefore the numbers of participants with recurrence up to 6 months is reported instead|up to 6 months||||participants|||Number
2627666|NCT01887327|Primary|Total Serum Bilirubin (mg/dL)|Total serum bilirubin (TSB) was measured at baseline (the measure that qualified the baby for inclusion) and at 48 hours after treatment. If a baby was discharged before 48 hours, the last measurement before discharge was used [last observation carried forward (LOCF)].|Baseline, 48 hours post-treatment|Intention to treat (ITT) analysis set|||mg/dL||Standard Deviation|Mean
2627667|NCT01887288|Secondary|Combination Overall Clinical Benefit by RECIST 1.1|Assess the activity of this combination in terms of overall clinical benefit rates (CBR), including complete response (CR), partial response (PR) or stable disease (SD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)|One year|data were not collected||||||
2627668|NCT01887288|Primary|Metronomic Capecitabine With Oral Digoxin|Evaluate the Growth Modulation Index (GMI) of the combination of metronomic capecitabine with oral digoxin in metastatic breast cancer|One year|data were not collected||||||
2627669|NCT01887210|Other Pre-specified|Information-Motivation-Behavioral Skills (IMB) Antiretroviral Therapy (ART) Behavioral Skills Scale|Behavioral Skills subscale from the Information-Motivation-Behavioral Skills (IMB) scale. This subscale measures self-efficacy for adherence to medical care related to antiretroviral medication and treatment. Five items were summed to get a total Behavioral Skills subscale score. Scores range from 5-25 where higher scores indicate greater self-efficacy for adherence to medical care related to ART medication and treatment.|24 weeks|Missing data for n=2 from IMB intervention, n=2 from TAU+|||units on a scale||Standard Deviation|Mean
2627670|NCT01887210|Secondary|Number of Kept Medical Appointments|Number of kept medical appointments since baseline.|24 weeks|Unable to pull information from chart for 9 participants in the IMB intervention and 6 in the TAU+ groups.|||appointments kept since baseline||Standard Deviation|Mean
2627671|NCT01887210|Secondary|Electronically Measured Past 7-day Adherence|Past 7 day medication adherence as measured by electronic medication monitoring device.|24 weeks|Missing data for n=1 from TAU+|||proportion of adherence||Standard Deviation|Mean
2627672|NCT01887210|Primary|Log10 HIV-1 Viral Load|Log viral load at end of study for participants with available viral load data (Log10 copies/ml)|24 weeks|Unable to extract viral load data from chart for 9 participants in IMB intervention and 1 in TAU+.|||Log10 copies/ml||Standard Deviation|Mean
2627673|NCT01887171|Secondary|Postreperfusion Hyperfibrinolysis|"Protocol is restricted to liver transplants performed with classic technique with sequential portal-arterial reperfusion.~Peripheral blood samples will be taken 15 min and 2 hours after portal reperfusion.~Hyperfibrinolysis will be diagnosed by Thromboelastometry (ROTEM) if one or more following criteria are met:~LI30<85% or ML>15% or LI60<85% or A10 in Extem is by 15% is less then A10 in Aptem."|15 min and 2 hours after portal reperfusion|||||||
2627674|NCT01887171|Secondary|Inflammatory Response to Reperfusion|"Protocol is restricted to liver transplants performed with classic technique with sequential portal-arterial reperfusion.~After unclamping portal vein but before unclamping the inferior vena cava and after venting of first 100 ml of blood a 5 ml sample of blood (code is HV) from a tube inserted into caval suture line will be taken. Another 5 ml sample of blood (code is C) will be taken by puncture of one of hepatic veins 20 min later. Samples (5 ml each) of peripheral blood will be taken on 1st and 3d postoperative day (POD). P-selectin, interleukin-6, interleukin-8, tumor necrosis factor alfa (TNF-a) and macrophage inflammatory protein 1 alpha (MIP-1a) will be determined in samples HV and C. Interleukin-8, elastase, TNF-a and vascular endothelial growth factor (VEGF) will be determined in samples of 1st and 3d POD."|0 and 20 min after portal reperfusion, 1 and 3 postoperative day|||||||
2627675|NCT01887171|Secondary|Ischemic Reperfusion Injury of the Liver Allograft|"Protocol is restricted to liver transplants performed with classic technique with sequential portal-arterial reperfusion.~A wedge resection of small (5x5mm) part of liver segment-III will be sampled at 2 hours after venous reperfusion. Rate of necrosis, inflammation, vascular thrombosis, cluster of differentiation (CD) 68 and High mobility group box 1 protein (HMGB1) staining will be assessed thereafter."|liver biopsy taken at 2 hours after portal reperfusion|||||||
2627676|NCT01887171|Primary|Early Allograft Dysfunction|"Protocol is restricted to liver transplants performed with classic technique with sequential portal-arterial reperfusion.~Early allograft dysfunction will be assessed on the basis of highest levels of AST and ALT during 1-7 postoperative days."|1-7 postoperative days after liver transplant procedure||||Participants|||Count of Participants
2627677|NCT01887132|Other Pre-specified|Vineland Parent Questionnaire at 3, 6, 12 and 18 Months||3, 6, 12 and 18 months|||||||
2627678|NCT01887132|Other Pre-specified|Autism Diagnostic Observation Schedule (ADOS) at 6, 12 and 18 Months||6, 12 and 18 months|||||||
2627679|NCT01887132|Other Pre-specified|Mullen Scales at 18 Months||18 months|||||||
2627680|NCT01887132|Other Pre-specified|An Exploratory Analysis Will Investigate Whether Normalization of REM Parameters Also Improves Other Measurements of Sleep Quality in Children With Autism.||12 months|||||||
2627681|NCT01887132|Secondary|REM Percentage at Baseline, 6, 12 and 18 Months|REM percentage is the percentage of sleep spent in REM|Baseline, 6, 12 and 18 months||||percentage of sleep|||Number
2627682|NCT01887132|Primary|Nonverbal Developmental Quotient (NVDQ)|"The Nonverbal Developmental Quotient (NVDQ) was calculated from the Mullen Scales of Early Learning scores by dividing the nonverbal mental age (average of the age equivalent value for the Visual Reception and Fine Motor scores) by the chronological age in months. The NVDQ is normalized to a mean score of 100, which indicates an average normal IQ. Less than 100 is a lower than average IQ. 2 standard deviations below average is considered impaired IQ (approximately lower than 70)."|Baseline and 12 months||||units on a scale|||Number
2627683|NCT01886963|Primary|Wound Complication|breakdown, necrosis, erythema, infection, or dehiscence with location specified|12 Weeks||||participants|||Number
2627684|NCT01886937|Primary|Food Intake|The primary outcome measure is food intake assessed by laboratory meal study after one week of phentermine administration compared to one week of placebo administration.|one week|This is a cross over design study. All participants received phentermine and placebo.The phentermine arm listed here includes all participants who received phentermine (regardless of whether they received it first or second). The placebo arm includes all those who received placebo (regardless of whether they received placebo first or second).|||kcal||Standard Deviation|Mean
2627842|NCT01884545|Primary|Waist Circumference|Waist circumference in cm|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||cm||Standard Deviation|Mean
2627685|NCT01886872|Other Pre-specified|Geriatric Functional Status (Optional)|"Assessed using the Older Americans' Resources and Services Multidimensional Functional Assessment Questionnaire, Activities of Daily Living, Medical Outcomes Study physical functioning, Karnofsky performance status rated by a health care professional, Karnofsky performance status rated by the patient, timed Up and Go, and number of falls in the last six months."|Performed at 2.5 years after the last patient enrolled|||||||
2627686|NCT01886872|Secondary|The Rate of Grade 3, 4, or 5 Treatment-related Non-hematologic Adverse Events (Toxicities)|The rate of grade 3, 4, or 5 treatment-related non-hematologic adverse events (toxicities) by arm; excludes adverse events occurring post-crossover for patients in Arm A|Performed at 2.5 years after the last patient enrolled; up to 4 years.|Patients who started treatment.|||percentage of patients|||Number
2627687|NCT01886872|Secondary|Percentage of Patients Who Attain Minimal Residual Disease (MRD) Negative Status|Estimated using the number of patients who achieve minimal residual disease divided by the total number randomized to that treatment arm. Corresponding exact binomial 95% confidence intervals for MRD rates will be calculated.|Cycle 9 Day 1 Evaluation|Intent-to-treat analysis population|||percentage of patients||95% Confidence Interval|Number
2627688|NCT01886872|Secondary|Percentage of Patients Achieving Complete (CR and CCR) or Nodular Partial Response (nPR)|Complete response (CR) requires all of the following: absence of lymphadenopathy > 1.5 cm on physical exam/CT scan, no hepatomegaly or splenomegaly on physical exam, no clonal B-cells in the blood, Normal CBC, bone marrow aspirate and biopsy must be normocellular for age. CR with exception of having bone marrow lymphoid CLL nodules will be considered a nodular PR (nPR). CR with exception of not having a bone marrow biopsy performed will be considered a clinical CR (CCR). Response rate and corresponding exact binomial 95% confidence intervals provided.|Performed at 2.5 years after the last patient enrolled; up to 4 years.|Intent-to-treat analysis population|||percentage of patients||95% Confidence Interval|Number
2627689|NCT01886872|Secondary|Percentage of Patients Achieving a Biopsy-proven Complete Response (CR)|Complete response (CR) requires all of the following: absence of lymphadenopathy > 1.5 cm on physical exam/CT scan, no hepatomegaly or splenomegaly on physical exam, no clonal B-cells in the blood, Normal CBC, bone marrow aspirate and biopsy must be normocellular for age. Complete response rate and corresponding exact binomial 95% confidence intervals provided.|Performed at 2.5 years after the last patient enrolled; up to 4 years.|Intent-to-treat analysis population|||percentage of patients||95% Confidence Interval|Number
2627690|NCT01886872|Secondary|Percentage of Patients Achieving Any Response to Treatment (Overall Response Rate [ORR] [Complete Response [CR], CCR, Nodular Partial Response [nPR], Partial Response [PR], and PRL])|Complete response (CR) requires all of the following: absence of lymphadenopathy >1.5 cm on physical exam/CT scan, no hepatomegaly/splenomegaly on physical exam, no clonal B-cells in the blood, Normal CBC, bone marrow aspirate & biopsy must be normocellular for age. Partial response (PR) requires >= 50% decrease in peripheral lymphocyte count from pre-treatment value, >= 50% reduction in lymphadenopathy, and/or ≥ 50% reduction in splenomegaly/hepatomegaly. CR with exception of having bone marrow lymphoid CLL nodules will be considered a nodular PR (nPR). CR with exception of not having a bone marrow biopsy performed will be considered a clinical CR (CCR). PR with the exception of having less than a 50% reduction in peripheral lymphocyte count will be considered a PR except persistent lymphocytosis (PRL).Overall response rate and corresponding exact binomial 95% CI provided.|Performed at 2.5 years after the last patient enrolled;up to 4 years.|Intent-to-treat analysis population|||percentage of patients||95% Confidence Interval|Number
2627691|NCT01886872|Secondary|Duration of Response (DOR) (Complete Response [CR], CCR, Nodular Partial Response [nPR], Partial Response [PR], and PRL)|The Kaplan-Meier method will be used to estimate median DOR. DOR is the time from first objective status to progression or death. CR requires all of the following: absence of lymphadenopathy > 1.5 cm on physical exam/CT scan, no hepatomegaly/splenomegaly on physical exam, no clonal B-cells in the blood, Normal CBC, bone marrow aspirate & biopsy must be normocellular for age. PR requires >= 50% decrease in peripheral lymphocyte count from pre-treatment value, >= 50% reduction in lymphadenopathy, and/or ≥ 50% reduction in splenomegaly/hepatomegaly. CR with exception of having bone marrow lymphoid CLL nodules will be considered a nodular PR (nPR). CR with exception of not having a bone marrow biopsy performed will be considered a clinical CR (CCR). PR with the exception of having less than a 50% reduction in peripheral lymphocyte count will be considered a PR except persistent lymphocytosis (PRL).|From the date of first response until progression or death, performed at 2.5 years after the last patient enrolled; up to 4 years.|Intent-to-treat analysis population achieving objective response|||months||95% Confidence Interval|Median
2627692|NCT01886872|Secondary|Overall Survival (OS) at 2 Years|The Kaplan-Meier method will be used to estimate the rate of overall survival at 2 years in each treatment arm. OS will be measured from the date of registration to the date of the event (i.e., death) or the date of last follow-up to evaluate that event. Patients who are event-free at their last follow-up evaluation will be censored at that time point.|From the date of registration to the date of death, assessed up to 2 years|Intent-to-treat analysis population.|||percentage of patients||95% Confidence Interval|Number
2627693|NCT01886872|Secondary|Progression Free Survival (PFS) Rate at 2 Years|The Kaplan-Meier method will be used to estimate the rate of progression free survival at 2 years in each treatment arm. Progression is defined as any one of the following: an increase in number of blood lymphocytes by >= 50%, >= 50% increase in the products of at least 2 lymph nodes on 2 consecutive determination 2 weeks apart, >= 50% increase in the size of the liver/spleen, transformation to a more aggressive histology, progression of any cytopenia (i.e. decrease of Hb levels > 2g/dL). Progression free survival time will be the time to either progression or death whichever occurs first.|Time from study entry to the time of documented disease progression or death, assessed up to 2 years|Patient evaluable for the primary endpoint are included in this analysis.|||percentage of patients||95% Confidence Interval|Number
2627706|NCT01886716|Primary|Liebowitz Social Anxiety Scale|The experimenter-administered Liebowitz Social Anxiety Scale (Liebowitz, 1987) was the primary measure to assess social anxiety symptoms. This well-validated instrument assesses fear and avoidance across a range of 24 social and performance situations during the course of the previous week. A total LSAS score was computed, ranging from 0 (no fear or avoidance) to 144 (the greatest level of fear and avoidance).|Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)||||units on a scale||Standard Deviation|Mean
2637576|NCT01780922|Primary|Reduced Glutathione (GSH) Concentrations in Red Blood Cells||0, 2, 4, 8, 24 h||||mmol/L||Standard Error|Mean
2627694|NCT01886872|Primary|Progression Free Survival (PFS)|The Kaplan-Meier method will be used to estimate the progression free survival distributions for each arm, with median estimates provided. Progression is defined as any one of the following: an increase in number of blood lymphocytes by >= 50% with >= 5000 B lymphocytes/mL in patients on Arm A or those on Arms 2 or 3 no longer receiving ibrutinib, >= 50% increase in the products of at least 2 lymph nodes on 2 consecutive determination 2 weeks apart, >= 50% increase in the size of the liver/spleen, transformation to a more aggressive histology, progression of any cytopenia (i.e. decrease of Hb levels > 2g/dL). Progression free survival time will be the time to either progression or death whichever occurs first.|Time from study entry to the time of documented disease progression or death. The analysis was event driven, performed at 2.5 years after the last patient enrolled;up to 4 years.||||months||95% Confidence Interval|Median
2627695|NCT01886833|Other Pre-specified|Sero-epidemiology of Breakthrough Rotavirus Infection in Immunized Infants|"Determination of genotype in every rotavirus causing severe gastroenteritis will be done each time stool samples are collected for diarrhoea. Patients presenting with any diarrhoea will be tested for rotavirus and staged clinically (by Vesikari score). Those with severe disease (e.g., Vesikari >11/20) will be processed for genotype. Thus, we will identify the number of rotavirus cases following vaccination as well as identify the strain in those with severe disease.~This will allow for wild type versus vaccinestrain mismatch evaluation. We anticipate that the circulating strains in the community will change in response to vaccine pressure at the population level. However, when interpreting reasons for vaccine failure, it is critically important to evaluate strain mismatch because the way to approach this type of breakthrough disease is dramatically different than if there is breakthrough infection to vaccine strain rotavirus."|42 months|There were 81 episodes of diarrhoea from which samples were collected. 15 were positive for rotavirus by EIA|||stool samples|stool samples||Count of Units
2627696|NCT01886833|Secondary|Proportion of Immunized Infants With Low Micronutrient Levels (as Indicated by Serum Zinc and Vitamin A), Who Fail to Seroconvert|To evaluation whether nutritional status affects vaccine take, we will assess the immunized infant's nutritional status as indicated by serum level of zinc and vitamin A. These will be correlated to seroconversion results.|1 month after full immunization|Of the 216 infants with paired serum IgA at baseline and after 1 month of complete immunization, 164 had deficient micronutrients|||Proportion micronutritionally deficient|||Number
2627697|NCT01886833|Primary|Proportion of Immunized Infants Exposed to Maternal HIV Infection Who Fail to Seroconvert|To evaluate whether maternal HIV infection (as well as level of CD4 count) affects infant vaccine take, we will collect the maternal HIV status, (and CD4 count if +ve). We will then correlate the maternal HIC status and CD4 count levels to infant zero conversion at 1 month after the two vaccine doses.|1 month after the two vaccine doses|Of the 420 mothers, 125 were confimed HIV+|||Proportion of exposed infants|||Number
2627698|NCT01886833|Primary|Proportion of Immunized Infants Exposed to Transplacentally-acquired, Rotavirus-specific, Infant Serum IgG Who Fail to Sero-convert.|"The co-primary exposure in this cohort is transplacentally acquired anti-rotavirus immunoglobulin-G.~We will collect infant serum at baseline before any vaccination and then measure the levels of anti-rotavirus-specific serum IgG and will also obtain the same at 1 month following the second dose of Rotarix™ rotavirus vaccine."|1 month after full immunisation|We did not test the serum IgG collected at 1 month following the second dose of Rotarix™ rotavirus vaccine because all infants were seropositve at baseline||||||
2627699|NCT01886833|Primary|Proportion of Immunized Infants Exposed to High Breast Milk Anti-rotavirus Immunoglobulin-A Who Fail to Seroconvert|"The primary exposure in this cohort is maternal IgA status, as we believe breast milk IgA is the most critical factor in failed vaccination, and maternal IgA has previously been estimated to be either high level (approximately 55%) or undetectable or low level (approximately 45%).~We will collect maternal serum and breast-milk IgA at the time of vaccination and then measure infant anti-rotavirus-specific serum IgA levels 1 month following the second dose of Rotarix™ (GlaxoSmithKline) rotavirus vaccine."|1 month following full immunization|Of the 420 participants that were enrolled in the study, we had rotavirus specific paired IgA at baseline and post vaccination for 216 infants.|||Proportion of exposed infants|||Number
2627700|NCT01886807|Secondary|Systolic Blood Pressure||From start of intubation attempt to completion of intubation, up to 10 mins||||mmHG||Standard Deviation|Mean
2627701|NCT01886807|Secondary|Heart Rate||From start of intubation, up to 10 mins||||beats per minute||Standard Deviation|Mean
2627702|NCT01886807|Primary|Time to 1% Saturation Drop|Kaplan-Meyer estimate 25th percentile along with adjusted 95% confidence limits were reported instead of usual 50th percentile (median) since there was not enough non-censored data for the DLO2 group (not many patients dropped 1% in SO2 from their baseline )|From beginning to end of laryngoscopy||||seconds||95% Confidence Interval|Median
2627703|NCT01886807|Primary|Time of Oxygen Saturation Change|In the primary hypothesis, desaturation will be characterized using both time to 1% saturation drop from the baseline and the rate (slope) of desaturation after an initial 1% drop.We will consider a given intubation technique (DLO2 or VL) better than DL on controlling saturation if found noninferior (i.e., not worse) on both outcomes and superior on at least one of the outcome. From start of intubation attempt to completion of intubation.|From start of intubation attempt to completion of intubation, up to 1 hour||||seconds||95% Confidence Interval|Mean
2627704|NCT01886781|Primary|A Change in Abdominal Pain Severity|The clinical severity of the IBS symptoms (pain and distension) was evaluated by the Francis Severity Score questionnaire (Francis 1997). The questionnaire is a validated tools for use in IBS. The severity score contained five questions, each given a value from 0 (no symptoms) to 100 (most severe) for measuring the severity and frequency of abdominal pain. The sum of scores of these questions was considered the severity score, with a maximum possible score of 500|Total trial period 12 weeks||||units on a scale||Standard Deviation|Mean
2627705|NCT01886716|Primary|The Daily Drinking Questionnaire|The Daily Drinking Questionnaire (Collins, Parks, & Marlatt, 1985) was the primary measure used to assess weekly alcohol consumption. This calendar-based measure was administered by the experimenter once per week to monitor changes in symptoms. The measure assessed the total number of drinks in the past week.|Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)||||number of drinks||Standard Deviation|Mean
2627736|NCT01885910|Secondary|Burning|the burning severity scale ranges from 0 to 10 with 0 being no burning and 10 being most extreme burning|every 4 weeks|participants with data|||units on a scale||Standard Deviation|Mean
2627707|NCT01886690|Secondary|Change From Baseline in Uncorrected Visual Acuity in the Worse Eye|Uncorrected visual acuity in the worse eye is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) without corrective lenses. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline in the number of letters read correctly indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, Day 90|Per Protocol: all randomized patients who had no significant protocol violations and who had data at the noted time point|||Letters Read Correctly||Standard Deviation|Mean
2627708|NCT01886690|Secondary|Change From Baseline in the Schirmer Test in the Worse Eye|The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes in the worse eye. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).|Baseline, Day 90|Intent-to-Treat: all randomized patients who had data at the noted time point|||Millimeters in 5 minutes (mm/5 min)||Standard Deviation|Mean
2627709|NCT01886690|Secondary|Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye|TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement) and a negative number change from baseline indicates a decrease in TBUT (worsening).|Baseline, Day 90|Intent-to-Treat: all randomized patients who had data at the noted time point|||Seconds||Standard Deviation|Mean
2627710|NCT01886690|Secondary|Change From Baseline in Corneal Staining in the Worse Eye|The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining in the worse eye following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative change from baseline represents a decrease in corneal staining (improvement) and a positive change from baseline represents an increase in corneal staining (worsening).|Baseline, Day 90|Per Protocol: all randomized patients who had no significant protocol violations and who had data at the noted time point|||Scores on a Scale||Standard Deviation|Mean
2627711|NCT01886690|Primary|Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale|The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability).|Day 90|Per Protocol: all randomized patients who had no significant protocol violations|||Scores on a Scale||Standard Deviation|Mean
2627712|NCT01886313|Primary|Average Daily Pain Score|The change in the Average Daily Pain Score (11-point Numeric Rating Scale (NRS)) from the Baseline Period to the Average Daily Pain Score of the last week of the Treatment Period. The minimum score is 0 and the maximum score is 10. A score of 0 indicates no pain while a score of 10 indicates worst possible pain.|6 weeks|1 patient withdrew early from study|||units on a scale||Standard Deviation|Mean
2627713|NCT01886300|Secondary|Number of Participants With Incidence of Adverse Events|An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product|Up to 24 months|Participants present at the time of assessment were used for analysis.|||Number of participants|||Number
2627714|NCT01886300|Secondary|Incidence of Normalization of Serum Alanine Transaminase|Normalization of alanine transaminase (ALT) values means that ALT values out of the normal range returned to within the normal range.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.||||||
2627715|NCT01886300|Secondary|Percentage of Participants Who Become Hepatitis B Envelope Antigen Negative During the Observation Period|HBeAg is a protein from the hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.||||||
2627716|NCT01886300|Secondary|Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid Suppression (<2,000 IU/mL) During the Observation Period|HBeAg seroconversion is defined as the absence of HBeAg and the presence of antibody to hepatitis B antigen (anti-HBe) . A participant was considered to have achieved suppression of HBV DNA to <2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.||||||
2627717|NCT01886300|Secondary|Percentage of Participants With Loss of Hepatitis B Envelope Antigen During the Observation Period|Loss of HBeAg is defined as the absence of HBeAg. A participant was considered to have achieved HBeAg loss if the HBeAg measurement was reported as (a) 'NEGATIVE' or (b) a quantitative result was lower than the reported lower detection limit.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.||||||
2627718|NCT01886300|Secondary|Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL During the Observation Period|A participant was considered to have achieved suppression of HBV DNA to <2,000 IU/mL if the HBV DNA measurement is lower than 2,000 IU/mL.|Up to 24 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.||||||
2641619|NCT01744392|Secondary|Weight at 6 Months|Clinical Characteristics at 6 months for Weight|6 months||||pounds||Standard Deviation|Mean
2627719|NCT01886300|Primary|Percentage of Participants Who Become Hepatitis B Envelope Antigen-Negative and Anti-HBe-Positive During Treatment and at 6 and 12 Months After End of Treatment|HBeAg is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus.|12 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.||||||
2627720|NCT01886300|Primary|Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL at 6 Months After End of Treatment|A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to <2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL.|6 months|As the sample size requirement for the study was not met, the study was terminated; no data for any of the participants was collected.||||||
2627721|NCT01886287|Secondary|Rate of Progression Free Survival (PFS) at 6 Months|Progression-free survival, defined as rate of patients alive and free of progression from the date of first study treatment to the end of trial at 6 months. Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.|At 6 months|Evaluable participants on study at 6 months||||||
2627722|NCT01886287|Primary|Number of Participants With Improved Frequency of Diarrhea|The frequencies of flushing, diarrhea, and carcinoid syndrome control rating (scale 1-5) will be measured and compared at week 0 and week 12 . These measurements will be compared using two-sided non-parametric paired Wilcoxon signed-rank.|At 12 weeks|Participants on study at 12 weeks|||participants|||Number
2627723|NCT01886235|Secondary|Tumor Vasculature|Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.|Up to 2 months|Stringent dosing requirements precluded assessment of tumor vasculature endpoints. These measurements will be addressed in future studies.||||||
2627724|NCT01886235|Secondary|Percentage of Participants With Treatment Response|Treatment response was based upon the presence of a recurrence of the melanoma at either primary or metastatic sites.|Up to 5 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2627725|NCT01886235|Secondary|Median Progression Free Survival|Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.|Up to 5 years|All treated and eligible patients|||months||95% Confidence Interval|Median
2627726|NCT01886235|Secondary|Median Overall Survival|Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.|Up to 5 years|All treated and eligible patients|||months||95% Confidence Interval|Median
2627727|NCT01886235|Secondary|Complication Rate|Number of participants with an event that would disrupt the standard surgical procedure or create an adverse event that would not be anticipated from the standard surgery.|Up to 5 years|All treated and eligible patients|||Participants|||Count of Participants
2627728|NCT01886235|Secondary|Blood Flow Rates|Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.|Up to 2 months|All treated and evaluable patients. Only 7 patients had data available, one patient had an unobservable tumor and two patients the fluorscein never made it to the tumor.|||micrometers per second||95% Confidence Interval|Mean
2627729|NCT01886235|Secondary|"Percentage of Participants With Any Adverse Event"|Percentage of participants with any adverse event. Described using upper one-sided 95% Clopper Pearson confidence limits.|Up to 5 years|All treated and eligible patients.|||percentage of participants||95% Confidence Interval|Number
2627730|NCT01886235|Primary|Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision|A successful intravital microscopic observation will include the ability to identify tumor vessels, measure tumor vessel diameters, determine vessel density per 10 x field and visualize fluorescein within the tumor vessels.|Up to 2 months|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2627731|NCT01886105|Secondary|Short and Long-term Side Effects of Combined Infusional Samarium-153 EDTMP and External Beam Radiotherapy as Assessed by Number of Participants With Toxicity|Number of patients experiencing any Grade 3-4 toxicity, as defined by CTCAE v4.0 and RTOG Cooperative Group Common Toxicity Criteria, during the trial intervention and follow-up.|Up to 48 months||||Participants|||Count of Participants
2627732|NCT01886105|Primary|Percentage of Treated Participants With 6-month Progression Free Survival|Percentage of patients with high-risk osteogenic sarcoma, treated with high-dose Samarium-153 EDTMP and external beam radiotherapy, without progression at 6 months.|6 months post-intervention||||Participants|||Count of Participants
2627733|NCT01885936|Secondary|Change in 6 Minute Walk Test|The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. Assessed by physical therapist.|Baseline, Week 6, and Week 52|Early participants were not randomized until 6 weeks; 3 drug and 2 placebo subjects could not be included in the analysis. One drug subject missed the Week 6 visit, and one placebo subject could not perform the 6 minute walk test. Later participants were unblinded before Week 52. Four drug and 3 placebo subjects could not be included at Week 52.|||meters||Standard Deviation|Mean
2627734|NCT01885936|Secondary|Change in Forced Vital Capacity From Pulmonary Function Tests at 30 Weeks and 52 Weeks.|FVC (forced vital capacity) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Week 30, and Week 52|One subject dropped out from the albuterol group. Later participants were unblinded and switched to drug before Week 52 under an IRB (Institutional Review Board) approved amendment, and 4 late-enrolled drug and 3 late-enrolled placebo subjects could not be included in the analysis at Week 52.|||Percent of predicted FVC||Standard Deviation|Mean
2627735|NCT01885936|Primary|Number of Participants With Adverse Events.|All participants who experienced adverse events.|52 weeks||||Participants|||Count of Participants
2641620|NCT01744392|Secondary|Weight at Baseline|Clinical Characteristics at Baseline for Weight|baseline||||pounds||Standard Deviation|Mean
2627745|NCT01885910|Primary|Percentage of Participants Who Remained Responders at Week 24|At week 12 responder had an IGA <3 on a 6-point scale ranging from 0 (clear) to 5 (very severe) and at Week 24 this response was maintained|Assessed every 4 weeks, reported at Week 24|only participants who were not lost to follow-up or did not withdraw consent were included in the final analysis|||percentage of particpants|||Number
2627746|NCT01885871|Secondary|Percent of Subjects With Post-treatment Adverse Event||During study duration 0-6 months.||||percent of participants|||Number
2627747|NCT01885871|Secondary|Mean Pain Score Associated With Laser Treatments|Subjects graded the level of pain associated with each laser treatment, using a 0-10 scale where 0=no pain and 10=worse possible pain, then averaged to get the mean across the treatments.|During treatments||||units on a scale||Full Range|Mean
2627748|NCT01885871|Secondary|Percent of Participants Satisfied With Improvement (Clearing) in Solar Lentigines|Level of Satisfaction with Improvement (clearing) in solar lentigines as assessed by participants, as measured by spot Improvement: 3=Very Much Improved, 2=Much Improved, 1=Improved, and 0=No Change.|12 weeks post- final treatment|Based on subject questionnaires, 90% of subjects reported improvement (clearing) in benign pigmented lesions at 12 weeks post- final treatment. Scores > or =1 indicate improvement.|||percent of participants|||Number
2627749|NCT01885871|Secondary|Percent of Participants With Improvement Score >/=1|Improvement (clearing) in solar lentigines as assessed by participant using a 4-point VAS 0-3 scale where 0=no change and 3=very much improved. Scores >/=1 indicate improvement.|12 weeks post- final treatment||||percent of participants|||Number
2627750|NCT01885871|Primary|Median VAS Improvement Score as Assessed by Blinded Physician Reviewers|Improvement (clearing) in solar lentigines as assessed by blinded physician reviewers using a VAS 4 point scale 0-3 where 0=no change and 3=Very much improved.|12 weeks post- final treatment|Based on blinded photographic assessments of 20 subjects. Scores >/=1 indicate clearing.|||units on a scale||95% Confidence Interval|Median
2627751|NCT01885559|Secondary|Back or Flank Pain|Report of back or flank pain since the last visit (yes or no)|48 months|Cross sectional analysis at 48 months is reported only for those participants responding at that time point. Intention to treat analysis was used for in the modeling over time to incorporate all repeated measures.|||percentage of participants at 48 months||95% Confidence Interval|Number
2627752|NCT01885559|Secondary|Quality of Life Mental Component Summary|Short Form-36 Quality of Life Mental Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years.|up to 8 years (annually assessed)|Intention to treat analysis|||units on a scale per year||95% Confidence Interval|Mean
2627753|NCT01885559|Secondary|Quality of Life Physical Component Summary|Short Form-36 Quality of Life Physical Component Summary ranges from 0 (worst possible outcome) to 100 (best possible outcome). Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual change across the 8 years.|up to 8 years (annually assessed)|Intention to Treat analysis|||units on a scale per year||95% Confidence Interval|Mean
2627754|NCT01885559|Secondary|Cardiovascular Hospitalizations|Cause-specific hospitalizations (cardiovascular)|up to 8 years|Intention to Treat analysis|||events|||Number
2627755|NCT01885559|Secondary|Hospitalizations|Hospitalization for any cause|up to 8 years|Intention to treat analysis|||events|||Number
2627756|NCT01885559|Secondary|Aldosterone|Annual percent change in urinary aldosterone, centrally processed measure. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope for time from the model). The measure presented is the average annual percent change across the 8 years.|up at 8 years (annually assessed)|Intention to treat analyses|||annual percent change||95% Confidence Interval|Mean
2627757|NCT01885559|Secondary|Albuminuria|Annual percent change in 24 hour urine albumin, centrally processed. Data from multiple years were analyzed with the primary focus on the change over time for the measure (from the slope of the model). The measure presented is the average annual percent change across the 8 years.|up to 8 years (annually assessed)|Intention to treat analysis|||annual percent change||95% Confidence Interval|Mean
2627758|NCT01885559|Primary|Number of Participants With 50% Reduction of Baseline eGFR, End Stage Renal Disease (ESRD, Initiation of Dialysis or Preemptive Transplant), or Death.||Patients followed for 5-8 years with average of 6.5 years follow up|Intention to Treat analysis was used for the primary outcome|||participants|||Number
2627759|NCT01885208|Secondary|Subjects Who Achieve HbA1c Equal to or Below 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target: (Yes/no)|The endpoint considered HbA1c ≤6.5% (48 mmol/mol) as per the AACE target after 56 weeks of treatment.|After 56 weeks' treatment|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.|||Participants|||Count of Participants
2627760|NCT01885208|Secondary|Change From Baseline in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs)|The Diabetes Treatment Satisfaction Questionnaire (DTSQs) was used to assess a subject's treatment satisfaction. This questionnaire contained 8 components and measures the treatment for diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment. The value presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Response options range from 6 (best case) to 0 (worst case). Total scores for treatment satisfaction range from 0-36. Higher scores indicate higher satisfaction.|Week 0, week 56|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.|||Units on a scale||Standard Error|Least Squares Mean
2627761|NCT01885208|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure|Mean changes in systolic and diastolic blood pressure from baseline to week 56.|Week 0, week 56|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.|||mm Hg||Standard Error|Least Squares Mean
2627762|NCT01885208|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Mean change in FPG from baseline to week 56.|Week 0, week 56|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.|||mg/dL||Standard Error|Least Squares Mean
2627763|NCT01885208|Secondary|Change From Baseline in Body Weight|Mean change in body weight from baseline to week 56.|Week 0, week 56|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.|||kilograms||Standard Error|Least Squares Mean
2627764|NCT01885208|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Mean change in HbA1c from baseline to week 56.|Week 0, week 56|The full analysis set (FAS) included all randomised subjects who had received at least one dose of randomised semaglutide 1.0 mg or exenatide ER 2.0 mg.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
2627765|NCT01885182|Secondary|The Chage of Symptoms of Constipation Based on Laxative Use From visit5 to visit8|At Visit5(day7) and visit8(day28) number of bisacodyl taken(Number of laxative tablets took during the last 7 days (per week) and Daily number of laxative tablets took during the last 7 days (per day)*) for OXN PR and OXY PR groups|visit 5 taking place at week 1 to visit8 taking place at week 4 or early discontinue/withdrawal from study where applicable|FAP|||laxatives/day||Standard Deviation|Mean
2627766|NCT01885182|Secondary|The Change of Bowel Movement by Visit|Number pf bowel movements(BM) and number of days the subjects had a bowel movement in the last 7 days before the study visit will be summarized at visit2(day0) ,visit5(day7),visit6(day14),visit7(day21), visit8(day28)..|visit2 (day 0) to visit8 (week 4 or early discontinue/withdrawal from study)|FAP|||Bowel movement/day||Standard Deviation|Mean
2627767|NCT01885182|Secondary|The Change of Individual Items in BPI-SF(Except for Pain in Average) by Visit|To compare the change of Brief pain inventory short-form (BPI-SF) 11 indivial items (except for pain in average) at visit2(day0) ,visit5(day7),visit6(day14),visit7(day21), visit8(day28). each item range (except for how much relief from treatment /medication last 24hours is 0-100%,do higher values represent a better outcome.) is 0-10, do higher values represent a worse outcome.|visit2 (day 0) to visit8 (week 4 or early discontinue/withdrawal from study)|FAP|||score on BPI-SF||Standard Deviation|Mean
2627768|NCT01885182|Secondary|To Assess Quality of Life Based on EQ-5D|To assess quality of life based on EQ-5D by subjects evaluation via patient dairy.the quality of life based on EQ-5D at Visit1 (day-10-0) and end of treatment Visit8(day28). The scarc range is 0(the best state you can imagine)-100(the worst state you can imagine).Do higher values represent a worse outcome.|Visit1(screening visit) to Visit8 (week 4 or after early discontinuation/withdrawal from study)|FAP|||Score on EQ-5D||Standard Deviation|Mean
2627769|NCT01885182|Secondary|The Change of Modified Subjective Opiate Withdrawal Scale (SOWS) From Visit1 to visit3,visit1 to visit9|to compare the Modified SOWS's Change from Visit 1(day-10-0) to Visit 3(day1),Change from Visit 1 to Visit 9(day35).The SOWS was scored as the total of the 15 symptoms. each symptoms score is 0(not at all)-4(extremely).total score range is 0-60.Do higher values represent a better outcome.|Visit1(screening visit) to visit3 (day 1), visit1(screening visit) to visit9 (week 5)|FAP|||score on SOWS||Standard Deviation|Mean
2627770|NCT01885182|Secondary|The Change of Rescue Medication Use From visit5 to visit8|The average daily dose of rescue medication (Morphine Sulfate Tablet) for OXN PR group and OXY PR group at Visit 5(first week of double blind) and at Visit 8(last week of double blind).|visit 5 (week 1) to visit8 (week 4 or early discontinue/withdrawal from study)|FAP|||Morphine Sulfate mg/day||Standard Deviation|Mean
2627771|NCT01885182|Secondary|The Change of Symptoms of Constipation Based on Laxative Use From visit5 to visit8|At Visit 5(day7) and visit8(day28) number of bisacodyl taken(Number of laxative tablets took during the last 7 days (per week) and Daily number of laxative tablets took during the last 7 days (per day)*) for OXN PR and OXY PR groups.|visit 5 (week 1) to visit8 (week 4 or early discontinue/withdrawal from study)|FAP|||laxatives/week||Standard Deviation|Mean
2627772|NCT01885182|Primary|The Change of BPI-SF at visit8|Brief pain inventory short-form(BPI-SF) recorded at final visit assesses subject's average pain over the last 24 hours. score range is 0(no pain)-10(pain as bad as you can imagine).Do higher values represent a worse outcome.|Visit8, visit8 taking place at week 4 or after early discontinuation/withdrawal from study|FAP|||Score on BPI-Brief Pain Index||Standard Deviation|Mean
2627773|NCT01885182|Primary|The Change of BFI-Bowel Function Index at visit8|"BFI is the mean of NAS for the following items:~Ease of defecation~Feeling of incomplete bowel evacuation.~Personal judgment of constipation. NAS was a measure of 0-100 where 0 was easy/no difficulty/not at all and 100 was severe difficulty/very strong,total score range is 0-300.Do higher values represent a worse outcome."|Visit8, visit8 taking place at week 4 or after early discontinuation/withdrawal from study|below presents the mean BFI at final visit, primary analysis in FAP.|||score on BFI||Standard Deviation|Mean
2627774|NCT01885117|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVf|The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period), after receiving one dose of TIVf is reported.|Day 1(baseline) through Day 22 postvaccination|Analysis was done on the safety set population|||Subjects|||Number
2627775|NCT01885117|Primary|Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of TIVf|The number of adult and elderly subjects reporting solicited local and systemic AEs and other solicited AEs after receiving one dose of TIVf are reported.|Day 1 through Day 4 postvaccination|Analysis was done on the safety set population i.e all subjects who have post-vaccination AE or reactogenicity records|||Subjects|||Number
2627776|NCT01885117|Primary|Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf|"The antibody responses following one dose of TIVf were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIVf.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22/ Day 1|Analysis was done on the per-protocol population|||Ratio||95% Confidence Interval|Geometric Mean
2627843|NCT01884545|Primary|Weight|Weight in kg|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||kg||Standard Deviation|Mean
2627844|NCT01884545|Primary|Medication Adherence as Measured by Morisky Adherence Survey MMAS8|Scores of the MMAS-8 range from 0 to 8. A score below 6 indicates low adherence, a score between 6 < 8 medium adherence and a score of 8 high adherence.|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||units on a scale||Standard Deviation|Mean
2627777|NCT01885117|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVf|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIVf.~Seroconversion is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 to at least a 4-fold increase in post vaccination HI antibody titers.~The related European (CHMP) criterion for the assessment of immunogenicity is met if>40 % for adults aged 18 to ≤60 years and>30% for subjects aged ≥61 years achieve seroconversion or significant increase in post vaccination HI titers."|Day 22 (postvaccination)/ Day 1 (baseline)|Analysis was done on the per-protocol population|||percentages of subjects||95% Confidence Interval|Number
2627778|NCT01885117|Primary|Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIVf.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 (baseline) and Day 22 (postvaccination)|Analysis was done on the per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
2627779|NCT01885117|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVf|"The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIVf.~The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22 (postvaccination)/ Day 1 (baseline)|Analysis was done on the per-protocol population|||Ratio||95% Confidence Interval|Geometric Mean
2627780|NCT01885117|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains ,three weeks after receiving one dose of TIVf.~Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤4mm2 achieving a post vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre vaccination SRH area >4mm2 achieving at least 50% increase in post vaccination SRH area.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years."|Day 22 (postvaccination) /Day 1 (Baseline)|Analysis was done on the per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
2627781|NCT01885117|Primary|Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVf|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIVf.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 (baseline) and Day 22 (postvaccination)|Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) confirmed influenza during the study.|||Percentages of subjects||95% Confidence Interval|Number
2627782|NCT01885104|Primary|Number of Participants With Inflammation of the Esophageal Mucosa|Participants underwent endoscopic examination of the esophageal mucosa at Visit 2 and Visit 3. Measurements were based on 0-3 Likert Scale Scores: 0 = No inflammation (no erythema, no erosion/ulceration); 1 = Mild inflammation (erythema without erosion/ulceration); 2 = Moderate inflammation (erythema with erosion); 3 = Severe inflammation (erythema with ulceration).|Visit 2 (Day 1) and Visit 3 (Day 17 ± 2 days), up to 19 days after start of treatment|Safety Population, which consisted of all participants who received at least 1 dose of PEG 3350 or placebo and had at least 1 postdose safety assessment.|||Participants|||Number
2627783|NCT01885104|Primary|Number of Participants With Inflammation of the Oral Mucosa|Participants underwent visual examination of the oral muscosa at Visit 2 and Visit 3. Measurements were based on 0-3 Likert Scale Scores: 0 = No inflammation (no erythema, no erosion/ulceration); 1 = Mild inflammation (erythema without erosion/ulceration); 2 = Moderate inflammation (erythema with erosion); 3 = Severe inflammation (erythema with ulceration).|Visit 2 (Day 1) and Visit 3 (Day 17 ± 2 days), up to 19 days after start of treatment|Safety Population, which consisted of all participants who received at least 1 dose of PEG 3350 or placebo and had at least 1 postdose safety assessment.|||Particpants|||Number
2627784|NCT01885000|Secondary|Percentage of Subject Reporting a Treatment-related Adverse Event||From consent signature, up to Day 8|APT (All Patient Treated) population|||percentage of participants|||Number
2627785|NCT01885000|Secondary|Percentage of Participants With at Least One Grade Improvement in the Clinician's Erythema Assessment (CEA)|Percentage of participants with at least one grade improvement in the CEA|Day 1, 3 hour after drug application|Participantes with a CEA score at this timepoint|||percentage of participants|||Number
2627786|NCT01885000|Secondary|Facial Appearance Since Starting the Treatment|"Percentage of subjects who answered A lot better/A little better to the question what do you think about your facial appearance since starting the treatment?"|Day 8|Subjects who answered the questionnaire at Day 8|||percentage of participants|||Number
2627787|NCT01885000|Primary|Satisfaction With the Overall Study Treatment|Percentage of participants who are very satisfied/satisfied/somewhat satisfied with the study treatment|Day 8|Subject who have answered the questionnaire at Day 8|||percentage of participants|||Number
2627845|NCT01884545|Primary|Smoking Status||12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol. Some participants were not analyzed because data were missing.|||Participants|||Count of Participants
2633474|NCT01824446|Primary|Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||ng equivalents/ml||Standard Deviation|Mean
2627788|NCT01884844|Primary|Change in Montgomery-Åsberg Depression Rating Scale|"Montgomery-Åsberg Depression Rating Scale Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.~The questionnaire includes questions on the following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts~Usual cutoff points are:~0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression."|baseline and at 12 week completion|Comparison of bimonthly scale measurements (MADRS, between treatment groups over time were done fitting individual Generalized Linear Models (GLMs) using the initial baseline measurement as an adjustment. Significance was fixed at 0.05%. SPSS v. 23 used|||units on a scale||95% Confidence Interval|Mean
2627789|NCT01884688|Primary|Increase in ENK (Expanded Natural Killer Cells) Cells 7 Days After Treatment|Number of participants with at least 4 fold increase in absolute CD3-CD56+ NK cell count/uL blood 7 days after infusion over the pre-study baseline level|7 days||||Participants|||Count of Participants
2627790|NCT01884675|Secondary|Number of Participants With Testicular Function (Males Only) of Potential Clinical Concern Any Time Post Baseline|For male participants testicular function (total testosterone, sex hormone binding globulin [SHBG-calculated free testosterone), follicle stimulating hormone (FSH), luteinizing hormone (LH), and inhibin B were assessed at Weeks 4 and 16/early withdrawal. The testicular function data were collected, but after the study was terminated, not all endpoints listed in the protocol were analyzed, including Testicular Function. This decision was documented in the reporting and analysis plan prior to database lock.|Baseline, Weeks 4 and 16/early withdrawal|ITT Population||||||
2627791|NCT01884675|Secondary|Number of Participants With Hematology Parameters of Potential Clinical Concern Any Time Post Baseline|Hematology parameters including hemoglobin, international normalized ratio (INR), and platelet count assessed any time post Baseline. Baseline is the last value recorded on or prior to start of study treatment. For hemoglobin: lower concern value and high concern value was considered as <100 gram per liter (G/L) and none respectively. For INR: lower concern value and high concern value was considered as none or >5 prothrombin time respectively. For platelet count: lower concern value and high concern value was considered as <50 giga cells per liter (GI/L) and >500 GI/L respectively. Participants with both normal and low values were counted once under their worst case (Low). Participants with both normal and high values were counted once under their worst case (High). Participants with both high and low values are counted under both categories.|Baseline (Week 0), Weeks 4, 8, 12 and 16/early withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||Participants|||Number
2627792|NCT01884675|Secondary|Number of Participants With Clinical Chemistry Parameters of Potential Clinical Concern Any Time Post Baseline|Clinical chemistry parameters including alanine amino transferase (ALT), aspartate amino transferase (AST), creatinine, gamma glutamyl transferase (GGT) and total bilirubin (TB) assessed any time post Baseline. ALT: lower concern value and high concern value was considered as none and >=3xupper limit of normal (ULN) respectively. AST: lower concern value and high concern value was considered as none or >=3xULN respectively. creatinine: lower concern value and high concern value was considered as none and >=176.8 micromoles per liter (umol/L) respectively. GGT: lower concern value and high concern value was considered as none and >=3xULN respectively. For TB: lower concern value was none and high concern value was >=2xULN. Participants with both normal and low values were counted once under their worst case (Low). Participants with both normal and high values were counted once under their worst case (High). Participants with both high and low values are counted under both categories.|Baseline (Week 0), Weeks 4, 8, 12 and 16/early withdrawal,|ITT Population|||Participants|||Number
2627793|NCT01884675|Secondary|Change From Baseline in Heart Rate Assessed at Weeks 4, 8, 12, and 16/Early Withdrawal|Vital sign measurements including heart rate at Weeks 4, 8, 12, and 16/Early Withdrawal weeks. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||beats per minute||Inter-Quartile Range|Median
2627794|NCT01884675|Secondary|Change From Baseline in Supine Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Assessed at Weeks 4, 8, 12, and 16/Early Withdrawal|Vital sign measurements including supine systolic and diastolic blood pressure at Weeks 4, 8, 12, and 16/Early Withdrawal weeks. Supine blood pressure measurement was taken in a supine position having rested in this position for at least 10 minutes before each reading. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||millimeter of mercury (mmHg)||Inter-Quartile Range|Median
2627795|NCT01884675|Secondary|Number of Participants With Significant Liver Events at Weeks 4, 8, 12, and 16/Early Withdrawal|A significant liver chemistry result is defined as any result which met the stopping criteria defined in the study protocol. Liver events were assessed at Screening, Baseline, Weeks 4, 8, 12, and 16/Early Withdrawal. Number of participants who reported a significant liver chemistry result are presented.|Weeks 4, 8, 12, and 16/Early Withdrawal|ITT Population|||Participants|||Number
2627796|NCT01884675|Secondary|Change From Baseline in Haematocrit Levels at Weeks 4, 8, 12, and 16/Early Withdrawal|Haematocrit levels were assessed at Screening, Baseline, Weeks 4, 8, 12, and 16/Early Withdrawal. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||Proportion of 1||Inter-Quartile Range|Median
2627797|NCT01884675|Secondary|Change From Baseline in Haemoglobin Levels at Weeks 4, 8, 12, and 16/Early Withdrawal|Haemoglobin levels were assessed at Screening, Baseline, Weeks 4, 8, 12, and 16/Early Withdrawal. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Week 0); Weeks 4, 8, 12, and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||Grams per liter||Inter-Quartile Range|Median
2627798|NCT01884675|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|From the start of study treatment and until follow up (Week 16/Follow up)|ITT Population|||Participants|||Number
2627799|NCT01884675|Secondary|Change From Baseline in Quality of Life as Measured by Short Form 36 Health Survey (SF-36)|The SF-36 v2 is a self-administered, health-related quality of life (QoL) metric. It is a 36-item questionnaire designed to measure 8 domains of functional health status and well-being: physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health as well as 2 summary measures (Physical Health and Mental Health). Each domain is scored from 0 (poorer health) to 100 (better health). Change from Baseline was calculated as the post-Baseline score minus the Baseline score. The SF-36 data were collected, but after the study was terminated, not all endpoints listed in the protocol were analyzed, including the SF-36. This decision was documented in the reporting and analysis plan prior to database lock.|Baseline and up to Week 16/Early Withdrawal|ITT Population||||||
2627800|NCT01884675|Secondary|Percent Change From Baseline in Plasma N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)|The ratio to baseline [BL] in NT-proBNP was calculated as the ratio of the value at the specified time-point to the BL value and was expressed as a percent change from BL. For each treatment group, the mean change from BL at the specified time-point was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the value at the specified time-point to BL on the original scale. The GM was expressed as a percentage (100*[GM - 1]). Standard Deviation(SD) is the SD of the mean change from baseline values on the log scale.|Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||Percent change||95% Confidence Interval|Geometric Mean
2627801|NCT01884675|Secondary|Change From Baseline in Cardiac Index at Week 16|Cardiac index is measure of cardiopulmonary hemodynamics. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value.|Baseline (Week 0) and Week 16|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint were summarized.|||Litre per minute per meter squared||Inter-Quartile Range|Median
2627802|NCT01884675|Secondary|Change From Baseline in Mean Right Atrial Pressure (mRAP) and Mean Pulmonary Artery Pressure (mPAP) at Week 16|mPAP and mRAP are measures of cardiopulmonary hemodynamics. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value.|Baseline (Week 0) and Week 16|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||Millimeter of mercury (mmHg)||Inter-Quartile Range|Median
2627803|NCT01884675|Secondary|Number of Participants With Clinical Worsening of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)|Clinical worsening of CTEPH is defined by the time from randomization to the first occurrence of death, lung transplantation, hospitalization for CTEPH, atrial septostomy, addition of parenteral prostanoids, or study withdrawal due to two or more early escape criteria included: a decrease from Baseline of at least 20 percent in the distance walked during the six-minute walk test; an increase of one or more WHO functional class; worsening right ventricular failure (e.g., as indicated by increased jugular venous pressure; new/worsening hepatomegaly, ascites, or peripheral edema; worsening echocardiographic parameters such as tricuspid annulus plane systolic excursion (TAPSE) and Tissue Doppler Imaging of the tricuspid annulus); rapidly progressing cardiogenic, hepatic, or renal failure; refractory systolic hypotension (systolic blood pressure less than 85 millimeter of mercury [mmHg]).|From randomization to Week 16/Follow up visit (21 weeks)|ITT Population|||Participants|||Number
2627804|NCT01884675|Secondary|Change From Baseline in Borg CR10 Scale (BCR10S) Immediately Following Exercise at Weeks 4, 8, 12 and 16/Early Withdrawal|"The BCR10S score was collected immediately following completion of the 6-minute walk test. Baseline data was calculated as the average of the two BCR10S values obtained following the two 6MWD tests used in determining the Baseline 6MWD. If only one measurement was available, that measurement has been used. BCR10S scores ranges from 0 to 10 (0=nothing at all, 10=extremely strong). If participant's perception or feeling was stronger than 10, i.e extremely strong, Maximal - a larger number could be used, e.g. 12 or still higher i.e Absolute maximum). Change from Baseline was calculated as the value at specified visit minus the Baseline value."|Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||Scores on a scale||Inter-Quartile Range|Median
2646946|NCT01699789|Secondary|>=2 Emergency Room Visits||6 months follow-up||||percentage of participants||95% Confidence Interval|Number
2627805|NCT01884675|Secondary|Change From Baseline in WHO Functional Class (FC) at Weeks 4, 8, 12 and 16/Early Withdrawal|The WHO FC indicates the severity of PAH and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. There are four grades for WHO FC based on severity of symptoms (Class I = none, Class IV = most severe). This functional classification system links symptoms with activity limitations, and allows clinicians to quickly predict disease progression and prognosis, as well as the need for specific treatment regimens, irrespective of the underlying etiology of PAH. Baseline is the last value recorded on or prior to start of study treatment. Change from Baseline was calculated as the value at specified visit minus the Baseline value. For analyse purposes, the WHO FC Class categories of I-IV were mapped to a numeric scale of 1-4.|Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||Scores on a scale||Inter-Quartile Range|Median
2627806|NCT01884675|Secondary|Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 16|PVR is a measure of cardiopulmonary haemodynamics. Change from Baseline was calculated as value at specified visit minus Baseline value. Baseline is the last value recorded on or prior to start of study treatment.|Baseline (Week 0) and Week 16|ITT Population. Only those participants with available data at Baseline and the specified timepoint were analysed.|||Dynes*second/centimeter^5||Inter-Quartile Range|Median
2627807|NCT01884675|Primary|Change From Baseline in Six Minutes Walking Distance (6MWD) at Week 16|The 6-minute walk test was conducted according to the American Thoracic Society guidelines in accordance with local standard operating procedures. 6MWD was measured by a 6-minute walk test. This test measures the distance that a participant can walk in a period of 6 minutes. Change from baseline was calculated at Weeks 4, 8, 12 and 16. Change from Baseline was calculated as value at the specified visit minus the Baseline value. Data at Baseline is based on average of two consecutive test results during Screening/Baseline period that differ by <10%. If only one measurement was available, that measurement was used. In any cases where the protocol-defined criteria for Baseline 6MWD was not met, the Baseline value was based on the last two consecutive measurements for a participant.|Baseline (Week 0); Weeks 4, 8, 12 and 16/Early Withdrawal|Intent-to-Treat (ITT) Population: comprised of all randomized participants who received at least 1 dose of study drug. Only those participants with available data at Baseline and the specified timepoint (represented as n=X, X for placebo and ambrisentan respectively) were summarized.|||Meters||Inter-Quartile Range|Median
2627808|NCT01884597|Secondary|Fundus Clinical Findings|Decrease in subretinal hemorrhage or exudates as measured by mean size as noted on fundus photography and clinic exam|Baseline, Months 6, 12, 24||||Participants with Fundus Findings|||Number
2627809|NCT01884597|Secondary|PCV Anatomic Changes|"Decrease and/or resolution in the branching vascular network of the PCV complex as measured by mean size of the branched vascular network (BVN) on ICG and fluorescein angiography~Decrease and/or resolution of the polyps of the PCV complex as measured on ICG and fluorescein angiography"|Baseline, Months 6, 12, 24||||Participants with PCV Anatomic Changes|||Number
2627810|NCT01884597|Secondary|Macular Edema|Optical Coherence Tomography (OCT) central macular and peripapillary thickness|Baseline, Day 14, Month 1-24|Patient in Cohort 2 missed several visits.|||microns||Standard Deviation|Mean
2627811|NCT01884597|Secondary|BCVA|Best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters, at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24|at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24||||number of letters read correctly||Standard Deviation|Mean
2627812|NCT01884597|Secondary|Systemic AEs|Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs|Monthly||||Number of Participants with Systemic AEs|||Number
2627813|NCT01884597|Secondary|Ocular Adverse Events (AE)|Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)|Monthly||||Ocular adverse events|||Number
2627814|NCT01884597|Primary|BCVA|Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from Baseline to Month 24|Baseline to M24||||number of letters read correctly||Standard Deviation|Mean
2627815|NCT01884597|Primary|BCVA|Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at a starting test distance of 4 meters from Baseline to Month 12.|From Baseline to Month 12||||number of letters read correctly||Standard Deviation|Mean
2627816|NCT01884571|Secondary|Collection of Blood for Future Analysis of Peripheral Blood Mononuclear Cells (PBMCs)|Blood was drawn and banked for future use in order to characterize immune system markers and further the understanding of the immune factors that contribute to disease progression in ALS.|Pre-Treatment Period (2 months prior to the start of treatment), Treatment Period (Day 1 and Months 1, 2, 4, 6), Post-Treatment Period (Months 8 and 12)|Blood was collected for all 31 participants and banked for future use.|||Participants|||Count of Participants
2627817|NCT01884571|Secondary|Collection of Cerebrospinal Fluid for Future Analysis of Cytokine Levels|Lumbar punctures (LPs) were performed to collect cerebrospinal fluid (CSF). CSF is banked for future use to characterize immune system markers and to further the understanding of the immune factors that contribute to disease progression in ALS. Cytokines are markers of neuroinflammation and can be categorized as neurotoxic or neuroprotective. The role that cytokines play in in ALS progression is still not yet fully understood.|Pre-Treatment Period (two months prior to the start of treatment), Treatment Period (Months 2 and 6), Post-Treatment Period (Month 12)|Cerebrospinal fluid was collected from 29 participants and banked for future analysis.|||Participants|||Count of Participants
2627847|NCT01884545|Primary|Dietary Intake as Measured by Daily Grams of Fiber|Dietary intake as measured by daily grams of fiber, adjusted for baseline|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||grams||Standard Deviation|Mean
2627848|NCT01884545|Primary|Dietary Intake as Measured by Percent Energy From Fat|Dietary intake as measured by percent energy from fat, adjusted for baseline|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||percent energy from fat||Standard Deviation|Mean
2627818|NCT01884571|Secondary|Mean Rate of Change of T-cell Subsets in Blood Treatment Compared to Pre-Treatment|Blood was collected for ribonucleic acid (RNA) and the mean rate of decline of T-cells during the 6 month treatment period compared to the pre-treatment period was assessed (blood was collected twice during the 3-month long lead in period). The precise role that T-cells have in ALS is unknown and this study aims to further the understanding of how T-cells operate in persons with ALS. T-cell measurement is a ratio where the relative expression levels of FOXP3 messenger ribonucleic acid (mRNA) was calculated using the Comparative CT Method (ΔΔCT Method), normalizing to β-actin. Samples were obtained during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline in T-cells over time.|Pre-Treatment Period (2 months prior to the start of treatment), Treatment Period (Day 1 and Months 1, 2, 4, 6)||||fold change per month||Standard Error|Mean
2627819|NCT01884571|Secondary|Mean Rate of Change in Grip Strength Treatment Compared to Pre-Treatment|Hand grip was measured using a study approved dynamometer to test the maximum isometric strength of the hand and forearm muscles. The grip strength of the left and right hands were analyzed together. Grip strength was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. Grip strength is a measurement of muscle strength and declines as ALS progresses. A positive value means that scores during treatment were higher than pre-treatment scores, indicating an increase in grip strength over time.|Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)||||pounds change per month||Standard Error|Mean
2627820|NCT01884571|Secondary|Mean Rate of Change of Hand-Held Dynamometry (HHD) During Treatment Compared to Pre-Treatment|Hand held dynamometry (HHD) is a measure of muscle strength and scores decrease as ALS progresses. Six proximal muscle groups were examined bilaterally in both upper and lower extremities. Mean and standard deviation for each muscle group are established from the initial values for each participant. Strength determinations were converted to Z scores and averaged to provide an HHD megascore. The Z-score indicates the number of standard deviations away from the mean of 0. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. HHD was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline in strength over time.|Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)|All study participants who received treatment are included in the analysis for this outcome measure, including participants who discontinued treatment early.|||z-score change per month||Standard Error|Mean
2627821|NCT01884571|Secondary|Mean Rate of Change of Slow Vital Capacity (SVC) During Treatment Compared to Pre-Treatment|Vital capacity (VC), percent of predicted normal, was determined using the slow VC method. SVC measures the amount of air exhaled following a deep breath. For this test, participants hold a mouthpiece in their mouth, breathe in deeply, and breathe out as much air as they can. The test was done seated in a chair and then repeated while lying on an exam table at the Screening Visit. For all other visits, this test was done while seated in a chair. This test takes 15-20 minutes. SVC was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. SVC is a way to measure respiratory insufficiency in persons with ALS and SVC decreases as ALS progresses. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline over time.|Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)|All study participants who received treatment are included in the analysis for this outcome measure.|||percent predicted change per month||Standard Error|Mean
2627822|NCT01884571|Secondary|Mean Rate of Change of ALSFRS-R Scores During Treatment Compared to Pre-Treatment|The ALS Functional Rating Scale - Revised (ALSFRS-R) is an ordinal rating scale (0 through 4) used to determine the ALS patient's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). Total scores range from 0 (most impaired) to 48 (normal ability). ALSFRS-R was measured during the 3 month lead in period and the 6 month treatment period. A random slopes model was fit to the lead-in and treatment periods, with a change point when treatment started. The analysis was based on the difference in slope after the change point. A negative value means that scores during treatment were lower than pre-treatment scores, indicating a decline in ability over time.|Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)|All study participants who received treatment are included in the analysis for this outcome measure, including participants who discontinued treatment early (available ALSFRS-R scores were used)|||units on a scale change per month||Standard Error|Mean
2627846|NCT01884545|Primary|Physical Activity, as Measured by the Stanford Brief Activity Survey (SBAS)|The Stanford Brief Activity Survey is a 2-item survey that assesses two categories of physical activity - work and leisure. There are five options for degree of activity to choose from in each of the two areas of activity. Activity categories (inactive, light-intensity activity, moderate-intensity activity, hard-intensity activity, and very hard-intensity) are represented in a table of different patterns. Degree of work activity is represented on the vertical axis and degree of leisure activity is represented on the horizontal axis. The overall activity level category is determined by where the two responses intersect.|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol. Some participants were not analyzed because data were missing.|||Participants|||Count of Participants
2627823|NCT01884571|Primary|Number of Participants With an Average Increase in ALSFRS-R Score of One Point Per Month|The ALS Functional Rating Scale - Revised (ALSFRS-R) is an ordinal rating scale (0 through 4) used to determine the ALS patient's self assessment of their ability and need for assistance in 12 activities or functions. This is a validated scale, both in person and by phone, which provides a total score (best of 48) from four sub-scores which assess speech and swallowing, (bulbar function), use of upper extremities (cervical function), gait and turning in bed (lumbar function), and breathing (respiratory function). A clinical response is defined as a rate of change of ALSFRS-R of +6 points over 6 months (mean of +1 point per month), where typically patients with ALS have a decline in ALSFRS-R by an average of -1/month.|Pre-Treatment Period (3 months prior to the start of treatment, 2 months prior to the start of treatment, and 1 month prior to the start of treatment), Treatment Period (Day 1 and then monthly until Month 6)|All study participants who received treatment are included in the analysis for this outcome measure, including participants who discontinued treatment early (available ALSFRS-R scores were used).|||Participants|||Count of Participants
2627824|NCT01884545|Secondary|Social Isolation|Single item to assess for availability of support person, where No=no support person.|6 months|Data is reported for participants who had data available at the 6 month visit. Randomization Arms/Groups were regrouped as pre-specified in the study protocol.|||Participants|||Count of Participants
2627825|NCT01884545|Secondary|Unmanaged Stress as Measured by the Perceived Stress Scale (PSS)|The PSS is a 10 item survey assessing feelings and thoughts of stress. Scores range from 0-40 with higher scores indicating higher perceived stress.|6 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||units on a scale||Standard Deviation|Mean
2627826|NCT01884545|Secondary|Depression, as Measured by the Beck Depression Inventory (BDI)|The Beck Depression Inventory is a 21-item measure that assesses self-reported symptoms of depression. It has been heavily used in research linking depression to heart disease. Scores range from 0-63, with 0 = minimal depression and 63 = severe depression.|6 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||units on a scale||Standard Deviation|Mean
2627827|NCT01884545|Secondary|Stages of Change|These evidence-based questions are validated and based upon the Transtheoretical Model and assess an individual's readiness to make behavioral change in 5 health behavior domains (dietary intake, exercise, weight loss, smoking cessation, and medication adherence).|6 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||Participants|||Count of Participants
2627828|NCT01884545|Secondary|Patient Activation Score|Patient activation is the degree to which patients accept an active role in their healthcare, and have the knowledge, skills and confidence to take care of their health. When scored as a continuous variable, the range is from 0 to 100, with higher numbers indicating greater levels of patient activation.|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||units on a scale||Standard Deviation|Mean
2627829|NCT01884545|Secondary|Perceived Risk for Type 2 Diabetes (T2D)|Investigator developed questions assessing level of personal perceived risk, fear, anger, worry regarding T2D risk. The consequences subscale ranges from 6-30. Higher scores on the consequences represent strongly held beliefs about negative consequences of the illness. The personal control subscale ranges from 6-30 and the treatment control subscale ranges from 2-10. Higher scores on the personal control and treatment control represent positive beliefs about the controllability of the illness. The emotional representations scores range from 6-30. Higher score indicates higher levels of worry or anxiety about risk of illness.|6 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||units on a scale||Standard Deviation|Mean
2627830|NCT01884545|Secondary|Perceived Risk for Coronary Heart Disease (CHD)|Investigator developed questions assessing level of personal perceived risk, fear, anger, worry regarding CHD risk. The consequences subscale ranges from 6-30. Higher scores on the consequences represent strongly held beliefs about negative consequences of the illness. The personal control subscale ranges from 6-30 and the treatment control subscale ranges from 2-10. Higher scores on the personal control and treatment control represent positive beliefs about the controllability of the illness. The emotional representations scores range from 6-30. Higher score indicates higher levels of worry or anxiety about risk of illness.|6 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||units on a scale||Standard Deviation|Mean
2627831|NCT01884545|Secondary|Diabetes Risk Score||12 months|risk score data was only collected and calculated at baseline||||||
2627832|NCT01884545|Secondary|Framingham Risk Score (FRS)||12 months|risk score data was only collected and calculated at baseline||||||
2627833|NCT01884545|Secondary|AF Composite Fitness Scores|Last annual fitness exam result, collected as pass or fail|12 months|Data only collected on active duty participants as part of their annual assessment. Randomization Arms/Groups were regrouped as pre-specified in the study protocol.|||Participants|||Count of Participants
2627834|NCT01884545|Secondary|Total Cholesterol|Adjusted for baseline|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||mg/dL||Standard Deviation|Mean
2627835|NCT01884545|Secondary|Body Mass Index (BMI)||12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||kg/m2||Standard Deviation|Mean
2627836|NCT01884545|Secondary|Fasting Blood Glucose|Adjusted for baseline|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||mg/dL||Standard Deviation|Mean
2627837|NCT01884545|Primary|Triglycerides|Triglycerides in mg/dL|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||mg/dL||Standard Deviation|Mean
2627838|NCT01884545|Primary|Low-density Lipoprotein (LDL)|Low-density lipoprotein (LDL) in mg/dL|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||mg/dL||Standard Deviation|Mean
2627839|NCT01884545|Primary|High-density Lipoprotein (HDL)|High-density lipoprotein (HDL) in mg/dL|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||mg/dL||Standard Deviation|Mean
2627840|NCT01884545|Primary|Diastolic Blood Pressure|Diastolic blood pressure in mmHg|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||mmHg||Standard Deviation|Mean
2627841|NCT01884545|Primary|Systolic Blood Pressure|Systolic blood pressure in mmHg|12 months|Randomization Arms/Groups were regrouped as pre-specified in the study protocol|||mmHg||Standard Deviation|Mean
2627849|NCT01884519|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0-180)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
2627850|NCT01884519|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 21-day (Days 0-20) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
2627851|NCT01884519|Secondary|Duration of Solicited General Symptoms.|Duration was defined as number of days with any grade of general symptoms.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
2627852|NCT01884519|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
2627853|NCT01884519|Secondary|Duration of Solicited Local Symptoms.|Duration was defined as number of days with any grade of local symptoms.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
2627854|NCT01884519|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
2627855|NCT01884519|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
2627856|NCT01884519|Secondary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2627857|NCT01884519|Secondary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2627919|NCT01883492|Secondary|Harris Hip Score at 3 Year Follow-up Visit|"Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are pain, function, absence of deformity and range of hip motion.~Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome."|3 year postoperative|12 patients in BIOLOX delta head group and 12 patients in CoCr head group missed collecting Harris Hip Score at 3 year visit.|||score on a scale||Standard Deviation|Mean
2627858|NCT01884519|Secondary|Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2627859|NCT01884519|Primary|Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value.|SPP was defined as the number of vaccinated subjects with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2627860|NCT01884519|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
2627861|NCT01884519|Primary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2627862|NCT01884519|Primary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2627863|NCT01884519|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2627864|NCT01884350|Secondary|Number of Participants With Serious Adverse Events (SAEs), Drug Related Adverse Events (AE), AE Leading to Discontinuation, and Death|Adverse events with onset date after 24 weeks are included in this summary. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Week 24 up to Week 48|All randomized participants remaining in the study after week 24. All randomized participants. Participants in the safety analysis set were categorized according to the counseling actually received|||Participants|||Number
2627865|NCT01884350|Secondary|Number of Participants With Serious Adverse Events (SAEs), Drug Related Adverse Events (AE), AE Leading to Discontinuation, and Death|AEs with onset date from day 1 through week 24 are included in this summary. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Day 1 up to week 24|All randomized participants. Participants in the safety analysis set were categorized according to the counseling actually received|||Participants|||Number
2627906|NCT01883804|Secondary|The Change in C-Peptide AUC Following a MMTT From Baseline to Study Completion.|Investigators aim to observe changes in residual endogenous insulin production as measured by C-peptide 2 hour area under the curve following a Mixed Meal Tolerance Test (MMTT). C-peptide is a measure of endogenous insulin secretion as both are secreted in a 1:1 molar ratio. Individuals ingested a liquid meal (Boost) with a fixed amount of protein, fat and carbohydrate in the fasting state followed by the timed measurements of serum C-peptide at 0, 15, 30, 60, 90 and 120 minutes to compute the AUC.|12 weeks (Baseline and week 12)||||nmol/L/min||Standard Deviation|Mean
2627866|NCT01884350|Secondary|Non-adherence Predictors of 20% or More (vs. at Least 80% Adherence) at 24 Weeks|Logit analyses were conducted on the Primary Efficacy Set to identify non-adherence predictors of 20% or more (vs. at least 80% adherence) at 24 weeks. In the Primary SOC group, alcohol use, Mini-Mental State Evaluation (MMSE) score, UK standard occupational classification, and type of atrial fibrillation were retained in the model (p-value <= 0.2). In the Additional Educational Program group, alcohol use, type of atrial fibrillation, age and Vitamin K Antagonists (VKA) status were retained in the model (p-value <= 0.2). Odds ratios are presented for predictors of non-adherence.|Week 24|Primary Efficacy Set participants with evaluable data at week 24|||Odds ratio||95% Confidence Interval|Number
2627867|NCT01884350|Secondary|Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen During the 24 to 48 Weeks Period|The mean percentage of days which participants maintained adherence to apixaban treatment was measured for each arm. Adherence to apixaban = number of units of adherence *100 / total number of eligible days for the time period from first dose date, up to 169 days. Unit of adherence: A 24-hour window where the treatment is taken as prescribed, ie, 1 tablet (5 mg or 2.5 mg, as appropriate) 2 times a day. If only one dose is missed in 24-hours, it is still considered as a unit of adherence. Adherence over 24 weeks was calculated as the percentage of adherence units within that period. If a participant discontinued from the study before 48 weeks, the denominator time period was censored at the earlier of last dose date or discontinuation date for discontinuation due to reasons unrelated to participant adherence, such as withdrawn consent, or AE; otherwise, the period was censored at the minimum of 169 days and last dose date + 30 days.|Week 24 to Week 48|All treated participants in 24 to 48-week period. Participants that had not been using the EMD consistently throughout the study were excluded from the analysis.|||percentage||Standard Deviation|Mean
2627868|NCT01884350|Secondary|Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen During the 12 to 24 Weeks Period Compared With During the First 12 Weeks|The mean adherence to apixaban treatment during the first 24 weeks was measured between the standard of care (SOC) information and Additional Education Program (AEP) arms and expressed as a percentage. Adherence to Apixaban = number of units of adherence *100 / total number of eligible days for the time period.|Day 1 to Week 12, Week 12 to Week 24|Primary efficacy analysis set (Week 24) with available data at both study days 85 and 169|||percentage||Standard Deviation|Mean
2627869|NCT01884350|Primary|Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen|The mean percentage of days which participants maintained adherence to apixaban treatment was measured for each arm. Adherence to apixaban = number of units of adherence *100 / total number of eligible days for the time period from first dose date, up to 169 days. Unit of adherence: A 24-hour window where the treatment is taken as prescribed, ie, 1 tablet (5 mg or 2.5 mg, as appropriate) 2 times a day. If only one dose is missed in 24-hours, it is still considered as a unit of adherence. Adherence up to 24 weeks was calculated as the percentage of adherence units within that period. If a participant discontinued from the study before 24 weeks, the denominator time period was censored at the earlier of last dose date or discontinuation date for discontinuation due to reasons unrelated to participant adherence, such as withdrawn consent, or AE; otherwise, the period was censored at the minimum of 169 days and last dose date + 30 days.|Day 1 up to week 24|Primary efficacy analysis set (Week 24), which consists of all randomized participants|||percentage of days||Standard Deviation|Mean
2627870|NCT01884337|Secondary|Number of Participants With Composite of Venous Thromboembolism (VTE)/All Cause Death at the End of Treatment + 2 Days|VTE is the combination of deep vein thrombosis and non-fatal pulmonary embolism.|2 weeks + 2 days for TKR, 5 weeks + 2 days for THR|All participants who received at least one dose of study drug|||Participants|||Count of Participants
2627871|NCT01884337|Primary|Number of Participants With Composite of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding/Clinically Relevant Non-major Bleeding (CRNM) While Undergoing Elective TKR or THR at the End of Treatment + 2 Days|"TKR = Total knee replacement; THR = Total hip replacement. ISTH major bleeding is 1) Fatal or 2) Bleeding in a critical organ, such as brain, spine, eye, retroperitoneum, joint, heart sac, or skeletal muscle (and resulting in compartment syndrome), or 3) Bleeding that results in a fall of hemoglobin of 2 g/dL or more or transfusion of 2 units or more of packed red cells or whole blood within 24 hours. CRNM bleeding is bleeding that~1) Is clinically acute and overt 2) Does not satisfy criteria as a major bleed but requires medical intervention, such as a visit to a physician's office, emergency room, or urgent care center for epistaxis"|2 weeks + 2 days for TKR, 5 weeks + 2 days for THR|All participants who received at least one dose of study drug during the Treatment Period|||Participants|||Count of Participants
2627872|NCT01884311|Other Pre-specified|Population PK Model for IgG in PID Patients for Alternative Dosing Schedules.|"Develop a population pharmacokinetic (PK) model for IgG in PID patients following IV (Gammaplex 5%) or SC (Subgam-VF) administration;~Conduct a formal covariate analysis to assess the impact of patient demographics, and disease-related factors on the PK of IgG following IV or SC administration and to identify those patient covariates which may be utilized in or require dose adjustment;~Use the final population PK model to simulate serum IgG concentration-time profiles in a population of PID patients in order to:~Assess switching from various IgG IV and SC dosing regimens; and~Derive the weight-adjusted dose increment required to achieve a specified difference in serum IgG trough levels when Subgam-VF is administered either weekly or biweekly"|30 months|"The analysis population included 50 Subjects from GMX01 (NCT00278954), 25 Subjects from GMX04 (NCT01289847) and 38 Subjects from SCIG03 Clinical Trials.~A measure type of 'number' has been used as this represents the predicted change in IgG trough levels when switching between Various IgG Dosing Regimens using a Dose Adjustment Factor of 1.37"|||% of predicted change in IgG trough|||Number
2627873|NCT01884311|Secondary|Number of Infusion Site Reactions|Infusion site reactions are defined as those events with onset date between the first infusion date and 28 days after the last infusion.|30 weeks|Total number of participants was 38|||infusion site reactions|||Number
2627907|NCT01883804|Primary|The Change From Baseline of DQ8 Antigen Presentation by Peripheral Blood Mononuclear Cells After 6 Weeks of Methyldopa Treatment.|Cryopreserved primary peripheral blood mononuclear cells were used as antigen presenting cells to stimulate engineered T-cells (T-cell receptor transductant) responding to a specific peptide presented by HLA-DQ8. Secreted IL-2 from the engineered T-cell was measured by a highly sensitive ELISA. This was done for both an α-gliadin/DQ8 responding T-cell and a separate insulin/DQ8 responding T-cell.|6 Weeks (Baseline and week 6)||||pg/mL||Standard Error|Least Squares Mean
2627874|NCT01884311|Secondary|Dose Refinement in Switching From Gammaplex 5% IGIV to Subgam-VF|"The initial weekly dose of Subgam-VF administered was calculated by taking the average weekly equivalent of the subject's IGIV dose, divided by the average dosing interval in weeks (i.e. 3 or 4), multiplied by 1.37, a dose adjustment coefficient based on other licensed subcutaneous IgG products. If the subject was already receiving a weekly SCIG IgG there will be no dose adjustment.~A refined dose adjustment was estimated as 1.37/the ratio (Subgam-VF/ Gammaplex 5% IGIV) of geometric means for sAUC0-t and presented with 90% CI."|Week 26|The PK Dose-Adjustment population included all those in the Subgam PK population who had previous treatment with IGIV and those in the Gammaplex 5% PK population. This population was analysed to estimate a refined dose adjustment factor.|||Ratio||90% Confidence Interval|Geometric Mean
2627875|NCT01884311|Secondary|Number of Participants Who Experienced AEs Based on Treatment-emergent AEs (TEAEs)|TEAEs defined as those events with onset date between the first infusion date and 28 days after the last infusion.|30 weeks|The intent-to-treat population included all subjects who received at least 1 infusion of Subgam-VF.|||Participants|||Count of Participants
2627876|NCT01884311|Primary|Data (Derived From Absolute Concentration) Were Pooled With Historical Data and a Treatment Variable Defined (Subgam-VF or Gammaplex 5% IGIV). Outcome Measure Defined as Log Transformed sAUC0-t Standardized to One Week.|Log transformed sAUC0-t, (AUC0-t standardized to one week) were analysed using a multiple linear regression model fitted including treatment, allowing for variability between treatment groups. The mean difference (Subgam-VF or Gammaplex IGIV 5%) between treatments with 90% Confidence Interval (CI) were back transformed to give an estimate of the ratio (Subgam-VF/ Gammaplex 5% IGIV) of sAUC(0-t). Data was collected at the following timepoints after week 21 of the clinical trial over a period of 1 week: Pre-dose on Day 0 and post-dose at days 1, 2, 3, 5 and 7.|1 week|"Subgam PK Population was defined as all subjects in the ITT population who had a pre-dose sample at steady state and at least 4 post-dose samples at steady state, 1 of which should have been the Day 7 PK sample.~Population included 50 Subjects from GMX01 (NCT00278954), 25 Subjects from GMX04 (NCT01289847) and 38 Subjects from SCIG03."|||Ratio||90% Confidence Interval|Mean
2627877|NCT01884077|Secondary|Shoulder Strength and Motion Based on Physican Examination|Research team member measures both shoulder range of motion (using a goniometer) and strength based on the standardized American Shoulder and Elbow Surgeons Society (ASES)examination. Physical Examination includes the following: forward elevation, external rotation, internal rotation, external rotation at side, Internal rotation extension with lift off exam, Horn Blower's, external rotation strength, thumb down abduction strength, abdominal compression test, Biceps rupture, Speeds Test, and Yergason's Test. External and Thumb Down abduction are measured with Iso-Force machine. Preoperative and 2 year post-operative range of motion and strength measurement score averages will be compared and reported for both groups (total 34 patients).|2 years post shoulder replacement|This study has been discontinued. This study has been discontinued and data was not sufficiently collected for any participant.||||||
2627878|NCT01884077|Primary|WOOS Score|"a disease-specific quality-of-life instrument (Western Ontario Osteoarthritis of the Shoulder [WOOS]. WOOS Score will be generated for both groups pre-operatively and 2 years post operatively: Reverse arthroplasty(17 patients) and Total arthroplasty (17 patients)~Study has been discontinued"|2 years after shoulder replacement|This study has been discontinued. This study has been discontinued and data was not sufficiently collected for any participant.||||||
2627879|NCT01884077|Primary|ASES Score|American Shoulder & Elbow Survey (ASES): Assessment of patient-rated shoulder pain and function/disability. Questions involve activities of daily living that reflect the use of the shoulder & elbow in different planes of motion. Pain and weakness with various activities are also addressed. ASES score will be calculated, compared and reported for both groups pre-operatively and 2 years post operatively: (17 patients) total arthroplasty and (17 patients) reverse arthroplasty.|2 years after shoulder replacement|This study has been discontinued and data was not sufficiently collected for any participant.||||||
2627880|NCT01884064|Primary|Cortical Silent Period|Subjects performed an isometric abduction contraction of the index finger against a strain gauge coupled to a load cell. A single TMS pulse was applied 2-3 s after contraction initiation and subjects were instructed to relax 2-3 s after stimulation. The duration of the CSP was measured on a trial-by-trial basis and was delineated by the first superimposed TMS-evoked EMG spike (onset) and the return of activity to 50% of prestimulus EMG signal (offset). The mean CSP duration was calculated for each block of measurements. The duration of CSP is thought to be related to intracortical GABAergic synapse-mediated inhibition in the stimulated cortical region. Measures of CSP have been shown to be reliable in repeated measures studies to determine an effect of intervention within a group of subjects (Orth and Rothwell 2004; Borich et al., 2009). Values are calculated as the value recorded at the latest time minus the earliest time point.|Baseline and Day 5||||milliseconds||Standard Deviation|Mean
2627881|NCT01884025|Secondary|Number of Participants Beginning New Health Behaviors From the Beginning of Classes Through Three Months Post End of Class|A chart review was completed in order to identify documentation of new health behaviors. Mental health notes were first reviewed and then key terms were searched in all notes during the time period. S We considered a new health behaviors as: Starting or increasing physical activity in a formal program; Starting or increasing physical activity on own; Starting nicotine replacement/report cutting down or quitting smoking/join a smoking cessation group; Treatment for alcohol or SA/Report cutting down on Alcohol use; Report changing diet/formal nutrition consult/etc. Chart abstractors were instructed to make free text notes explaining each event the counted. These were reviewed by the PI for accuracy.|Start of class through 3 months post-class|Veterans who completed both baseline and follow-up measures.|||participants|||Number
2627882|NCT01884025|Secondary|Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Cognitive Duration|"Physical activity and cognitive/social activity will be measured by the CHAMPS (Stewart, et al., 2001) which asks respondents to identify if they participated in an activity (yes or no) how many times a week they participated (continuous variable) and if they did participate, for how many hours per week (rated on a 1-6 point scale ranging from less than one hour to more than 9 hours). The CHAMPS assesses for both physical and social/cognitive activities (e.g., Visit with friends or family (other than those you live with); walk briskly)."|baseline and 12 week follow-up|Participants who completed baseline and follow-up measures|||units on a scale||Standard Deviation|Mean
2630587|NCT01853072|Secondary|Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60||Baseline to Day 60|Full analysis set|||Percentage of participants|||Number
2627883|NCT01884025|Secondary|Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Cognitive Activity Frequency|"Physical activity and cognitive/social activity will be measured by the CHAMPS (Stewart, et al., 2001) which asks respondents to identify if they participated in an activity (yes or no) how many times a week they participated (continuous variable) and if they did participate, for how many hours per week (rated on a 1-6 point scale ranging from less than one hour to more than 9 hours). The CHAMPS assesses for both physical and social/cognitive activities (e.g., Visit with friends or family (other than those you live with); walk briskly)."|baseline and 12 week follow-up|Participants who completed baseline and follow-up measures|||times/week||Standard Deviation|Mean
2627884|NCT01884025|Secondary|Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity Duration|"Physical activity and cognitive/social activity will be measured by the CHAMPS (Stewart, et al., 2001) which asks respondents to identify if they participated in an activity (yes or no) how many times a week they participated (continuous variable) and if they did participate, for how many hours per week (rated on a 1 - 6 point scale ranging from less than one hour to more than 9 hours). The CHAMPS assesses for both physical and social/cognitive activities (e.g., Visit with friends or family (other than those you live with); walk briskly)."|baseline and 12 week follow-up|participants who completed both baseline and follow-up measures|||units on a scale||Standard Deviation|Mean
2627885|NCT01884025|Secondary|New Health Behaviors From the Beginning of Classes Through Three Months Post End of Class|A chart review was completed in order to identify documentation of new health behaviors. Mental health notes were first reviewed and then key terms were searched in all notes during the time period. S We considered a new health behaviors as: Starting or increasing physical activity in a formal program; Starting or increasing physical activity on own; Starting nicotine replacement/report cutting down or quitting smoking/join a smoking cessation group; Treatment for alcohol or SA/Report cutting down on Alcohol use; Report changing diet/formal nutrition consult/etc. Chart abstractors were instructed to make free text notes explaining each event the counted. These were reviewed by the PI for accuracy.|Start of class through 3 months post-class|Veterans who completed both baseline and follow-up measures.|||Events|||Number
2627886|NCT01884025|Secondary|Acceptability|Measure of Patient self-report of acceptability of intervention. Participants responded to four questions using a 7 (0-7) point likert-type scale with higher ratings indicating higher acceptability. These were summed for a total score ranging from 0-28.|follow-up|participants who completed follow-up measures.|||units on a scale||Standard Deviation|Mean
2627887|NCT01884025|Secondary|Change in Intent to Engage|Intent to engage in health promotion was measured with an established scale (Ajzen, 1991) adapted for this project. The Intent To Engage questionnaire consists of eight questions each assessing assess intent, confidence and social support to complete health promotion activities. Each of these is rated on a likert-type scale ranging from 1-7 with some responses reverse scored so that higher responses indicate better intent, confidence, and social support. These are summed for a total score. Total scores range from 24 to 56.|Baseline and Follow-up|Participants who completed both baseline and follow-up measures|||units on a scale||Standard Deviation|Mean
2627888|NCT01884025|Secondary|Change in Personal Health Information Depression Scale (PHQ-8)|Depression will be measured by the Patient Health Questionnaire-8 (PHQ-8) which has been validated across several populations (Kroenke & Spitzer, 2002). Respondents rate how often they were bothered by eight problems on a likert-type scale ranging from 0 (not at all) to 3 (nearly every day). Scores can range from 0-24; higher scores indicate higher levels of depression with score >10 indicating clinically relevant depression.|Baseline and Follow-up|participants who completed both baseline and follow-up measures|||units on a scale||Standard Deviation|Mean
2627889|NCT01884025|Secondary|Change in Veterans RAND 12 (VR-12)|The VR-12 is based on the Veterans RAND 36 (SF-36) and has been shown to be a good outcome measure of general physical and mental health with significant correlations with morbidity (Kazis, et al., 2006). It provides physical and mental health subscale scores. It consists of 12 questions (several with sub sections) which are rated on three point and five point likert-type scales. These ratings are then assigned values with some scored opposite so that higher values always indicate more positive health. The Physical Health component can range from 10-59 and the Mental Health component from 6-33.|Baseline and Follow -up|Participants who completed both baseline and follow-up measures|||units on a scale||Standard Deviation|Mean
2627890|NCT01884025|Secondary|Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity Frequency|"Physical activity and cognitive/social activity will be measured by the CHAMPS (Stewart, et al., 2001) which asks respondents to identify if they participated in an activity (yes or no) how many times a week they participated (continuous variable) and if they did participate, for how many hours per week (rated on a six point scale ranging from less than one hour to more than 9 hours). The CHAMPS assesses for both physical and social/cognitive activities (e.g., Visit with friends or family (other than those you live with); walk briskly)."|baseline and 12 week follow-up|Participants who completed baseline and follow-up measures|||times per week||Standard Deviation|Mean
2627891|NCT01884025|Secondary|Change in Exercise Self-Efficacy Questionnaire|"Based on the exercise self-efficacy factors of resisting relapse and making time for exercise, the Exercise Self-Efficacy questionnaire asks respondents to circle how confident they are about their ability to exercise under difficult conditions, such as when I am tired. An additional item will be added to include hot weather as a possible barrier to physical activity, because of the likelihood of high spring and summer temperatures in our location. This scale was found to be highly reliable (test-retest reliability was .90) (Markus et al., 1992). It is made up of six questions each on a likert-type scale ranging from 1 (not at all confident) to 7 (very confident). These are ratings are then summed for the total score; total score ranges from 6-42 with higher scores indicating higher exercise self efficacy."|Baseline (Time point 0 - Pre intervention/control class) and follow-up (Time point Week 12 - after completion of intervention/attention control class)|Analysis population includes participants who completed both baseline and follow-up measures.|||units on a scale||Standard Deviation|Mean
2628119|NCT01881737|Secondary|Sensory Profile Questionnaire Total Score|scores on a scale (range: 38-190); lower scores mean more abnormal sensory problems.|12|During the 12-week treatment period, two participants dropped out of the study. The follow-up observations for one of the participants who dropped out were included in the analyses.|||scores on a scale (range: 38-190)||Standard Deviation|Mean
2627892|NCT01884025|Primary|Change in Behavioral Activation for Depression Scale|The BADS asks respondents to rate how much the statements are true for four subscales: Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment. It has been found to have acceptable internal consistency (Cronbach's alpha of .87), test-retest reliability (Pearson's r = .74), good construct validity, and when administered to a clinically depressed sample, the factors held up. Items for each subscale are summed to generate subscale scores. The BADS is made up of 25 questions with response option range from 0 (not at all) to 6 (completely). (Subscore Ranges: Activation: 0-108, Avoidance/Rumination: 0-102, Work/School Impairment: 0-120, Social Impairment: 0-120 Total: 0-150). For all subscales, high scores are consistent with the scale name.|Baseline (Time point 0 - Pre intervention/control class) and follow-up (Time point Week 12 - after completion of intervention/attention control class)|Analysis population includes participants who completed both baseline and follow-up measures.|||units on a scale||Standard Deviation|Mean
2627893|NCT01883999|Secondary|Freedom From New Onset Buttock Claudication Arising From the Side of the Body Treated With the Iliac Branch Component (IBC) and Internal Iliac Component (IIC)|Freedom from new onset buttock claudication arising from the side of the body treated with the Iliac Branch Component (IBC) and Internal Iliac Component (IIC).|Through 6 month follow-up visit|Subjects having IBC and IIC components implanted and meeting inclusion/exclusion criteria|||participants|||Number
2627894|NCT01883999|Primary|Freedom From: Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) Due to Type I/III Endoleak or to Re-establish Patency Due to 60% Occlusion or Greater, or Complete Loss of Blood Flow in Leg of IBC or IIC|"Freedom from all of the following:~Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) due to Type I/III endoleak as determined by Clinical Events Committee (CEC).~Complete loss of blood flow in leg of IBC or IIC as assessed by Core Laboratory~Reintervention on IBC or IIC to re-establish patency due to 60% occlusion or greater as determined by CEC."|Through 6 month follow-up visit|Subjects having IBC and IIC components implanted and meeting inclusion/exclusion criteria|||participants|||Number
2627895|NCT01883999|Primary|Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair|Freedom from composite of the following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to open surgical repair.|30 days post-treatment|Subjects initiating IBE procedure and meeting inclusion/exclusion criteria|||participants|||Number
2627896|NCT01883986|Secondary|Change From Baseline in Clinician Knowledge of Patient Preferences at 3 Months|Clinician knowledge of patient preferences for life sustaining treatments will be assessed at baseline and at the study end point by asking 2 validated questions to both the clinician and the patient and determining the level of agreement between the responses.|Baseline and 3 months|No data was collected due to poor provider response to surveys.||||||
2627897|NCT01883986|Secondary|Change in Baseline Quality of Clinician Communication at 3 Months|"The quality of clinician end-of-life communication will be measured from the patient's perspective by the Quality of Communication Questionnaire (QOC).The QOC consists of 13 items divided into two subscales, six general communication items and seven end-of-life topics. We analyzed the six-item general communication skills scale, which scores range from 0-10. The higher the score the better the provider's communication is. We asked patients to answer the questions in reference to the provider who was primarily responsible for managing their lung cancer."|Baseline and 3 months||||units on a scale||Standard Deviation|Mean
2627898|NCT01883986|Secondary|Change From Baseline in Patient Satisfaction of Care at 3 Months|Patient satisfaction with care will be assessed by using the FAMCARE- Patient Survey 13 (full unabbreviated scale name). The FAMCARE is a 13 item, 5 point likert-scale validated questionnaire measuring patient satisfaction with cancer care and assessing interactions with health care providers, performance status and symptom burden. Only total scores are reported (no subscales). The total scores range from 13-65 with scores of 52 > indicating satisfaction with care. The higher the score the better the outcome (better satisfaction with care). In full randomized clinical trials, the estimated minimal important difference is 5 points from baseline to 12 weeks.|Baseline and 3 months||||units on a scale||Standard Deviation|Mean
2627899|NCT01883986|Primary|Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at 3 Months|Patient Quality of Life including symptoms as measured by the FACT-L (Functional Assessment of Cancer Therapy-Lung Scale). The FACT-L outcome measure reported is the mean change in the TOI subscale (Total Outcome Index) of the instrument, computed as the differences between final and baseline visit scores. The TOI subscale range is 0-84 with a higher score indicating a better quality of life.|Baseline and 3 months||||units on a scale||Standard Deviation|Mean
2627900|NCT01883908|Primary|Number of Patients Completing Acupuncture Treatment|Feasibility is defined as greater than 80% patients in the trial completing at least 4 acupuncture sessions.|16 weeks|Zero participants analyzed due to early termination of study.||||||
2627901|NCT01883908|Primary|Side Effects of Acupuncture Treatment|All acupuncture side effects will be recorded|16 weeks|Zero participants analyzed due to early termination of study.||||||
2627902|NCT01883895|Secondary|Pain Threshold|Subjects will press a button attached to a timer out of view of the subject when the pressure stimulus first becomes painful. This will utilize a protocol recognized as a validated measurement of pain threshold.|We will monitor the subject's reported pain thresholds during the two minute interval that the pressure stimulus is applied. Expected average is less than one minute.||||seconds||95% Confidence Interval|Mean
2627903|NCT01883895|Primary|Change in Pain Intensity Ratings (0-100 Pain Scale)|"Subjects will rate pain intensity using a 0 (no pain) to 100 (most intense pain imaginable) pain rating scale before and after application of a validated pressure stimulator immediately prior to, and after exercise.~Ratings will be recorded at 20 second intervals following each administration of the pressure stimulator for a total of 120 seconds. The ratings will then be averaged over all the time points."|Average pain rating over 120 seconds|Participants completing both exercise sessions and control session|||scores on a scale||95% Confidence Interval|Mean
2627904|NCT01883804|Secondary|The Change in Insulin Use From Baseline to Study Completion.|Exogenous insulin use per kg of body weight.|12 weeks (Baseline and week 12)||||units/Kg body weight||Standard Deviation|Mean
2627905|NCT01883804|Secondary|The Change in Hemoglobin A1c From Baseline to Study Completion.|Investigators aim to observe changes in hemoglobin A1c values, a measure of average blood glucose over the preceding 3 months.|12 weeks (Baseline and week 12)||||percentage||Standard Deviation|Mean
2627908|NCT01883635|Other Pre-specified|Provision of Social Support|Change in provision of social support from baseline to 6 weeks as reported by the cancer survivor was measured by the Dyadic Support Questionnaire (DSQ). At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-45, with higher scores signifying more support. We subtracted the baseline score from the 6 week DSQ score; the change score reported below thus has a range from -45 to 45, with higher scores signifying more support.|Baseline to post-intervention (6 weeks later)|This Additional Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).|||units on a scale||Standard Deviation|Mean
2627909|NCT01883635|Secondary|Immune Biomarkers|We measured improvement in immune biomarkers with IL-6, an inflammatory cytokine assessed in the serum of cancer survivors. Numbers presented below are change scores calculated by subtracting baseline IL-6 from post-intervention IL-6 (6 weeks later); lower numbers indicate less inflammation, hypothesized to be linked with better immune function.|Baseline to post-intervention (6 weeks later)|The Secondary Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).|||ng/mL||Standard Deviation|Mean
2627910|NCT01883635|Primary|Psychological Distress|Change in psychological distress in the cancer survivor from baseline to 6 weeks, as measured by the Profile of Moods States (POMS) total score. At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-200, with lower scores signifying less distress. We subtracted the baseline POMS score from the 6 week POMS score; the change score reported below thus has a range from -200 to 200, with lower scores signifying less distress.|Baseline to post-intervention (6 weeks later)|The Primary Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).|||units on a scale||Standard Deviation|Mean
2627911|NCT01883492|Secondary|UCLA Activity Score at 3 Year Follow-up Visit|"University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.~The score ranges from 1 to 10 (1 point increment), higher score means higher activity level."|3 year postoperative|12 patients in BIOLOX delta head group and 11 patients in CoCr head group missed colleting UCLA Activity score at 3 year visit.|||score on a scale||Standard Deviation|Mean
2627912|NCT01883492|Secondary|UCLA Activity Score at 2 Year Follow-up Visit|"University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.~The score ranges from 1 to 10 (1 point increment), higher score means higher activity level."|2 year postoperative|3 patients in BIOLOX delta head group and 9 patients in CoCr head group missed colleting UCLA Activity score at 2 year visit.|||score on a scale||Standard Deviation|Mean
2627913|NCT01883492|Secondary|UCLA Activity Score at 1 Year Follow-up Visit|"University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.~The score ranges from 1 to 10 (1 point increment), higher score means higher activity level."|1 year postoperative|2 patients in BIOLOX delta head group and 8 patients in CoCr head group missed colleting UCLA Activity score at 1 year visit.|||score on a scale||Standard Deviation|Mean
2627914|NCT01883492|Secondary|UCLA Activity Score at 6 Month Follow-up Visit|"University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.~The score ranges from 1 to 10 (1 point increment), higher score means higher activity level."|6 month postoperative|4 patients in BIOLOX delta head group and 12 patients in CoCr head group missed colleting UCLA Activity score at 6 month visit.|||score on a scale||Standard Deviation|Mean
2627915|NCT01883492|Secondary|WOMAC Osteoarthritis Index at 3 Year Follow-up Visit|"The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.~The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.~Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations."|3 year postoperative|14 patients in BIOLOX delta head group and 17 patients in CoCr head group missed colleting WOMAC questionnaire at 3 year visit.|||score on a scale||Standard Deviation|Mean
2627916|NCT01883492|Secondary|WOMAC Osteoarthritis Index at 2 Year Follow-up Visit|"The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.~The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.~Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations."|2 year postoperative|9 patients in BIOLOX delta head group and 16 patients in CoCr head group missed colleting WOMAC questionnaire at 2 year visit.|||score on a scale||Standard Deviation|Mean
2627917|NCT01883492|Secondary|WOMAC Osteoarthritis Index at 1 Year Follow-up Visit|"The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.~The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.~Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations."|1 year postoperative|6 patients in BIOLOX delta head group and 13 patients in CoCr head group missed colleting WOMAC questionnaire at 1 year visit.|||score on a scale||Standard Deviation|Mean
2627918|NCT01883492|Secondary|WOMAC Osteoarthritis Index at 6 Month Follow-up Visit|"The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.~The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.~Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.~Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations."|6 month postoperative|6 patients in BIOLOX delta head group and 11 patients in CoCr head group missed colleting WOMAC questionnaire at 6 month visit.|||score on a scale||Standard Deviation|Mean
2628120|NCT01881737|Secondary|Social Responsiveness Scale (SRS) Total Score|SRS total score (total range 0-195); higher scores mean more abnormal social behaviors.|12 weeks||||SRS total score (total range 0-195)||Standard Deviation|Mean
2627920|NCT01883492|Secondary|Harris Hip Score at 2 Year Follow-up Visit|"Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are pain, function, absence of deformity and range of hip motion.~Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome."|2 year postoperative|3 patients in BIOLOX delta head group and 9 patients in CoCr head group missed collecting Harris Hip Score at 2 year visit.|||score on a scale||Standard Deviation|Mean
2627921|NCT01883492|Secondary|Harris Hip Score at 1 Year Follow-up Visit|"Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are pain, function, absence of deformity and range of hip motion.~Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome."|1 year postoperative|1 patient in BIOLOX delta head group and 6 patients in CoCr head group missed collecting Harris Hip Score at 1 year visit.|||score on a scale||Standard Deviation|Mean
2627922|NCT01883492|Secondary|Harris Hip Score at 6 Month Follow-up Visit|"Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are pain, function, absence of deformity and range of hip motion.~Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome."|6 month postoperative|1 patient in BIOLOX delta head group and 13 patients in CoCr head group missed collecting Harris Hip Score at 6 month visit.|||score on a scale||Standard Deviation|Mean
2627923|NCT01883492|Primary|Polyethylene Wear Between Immediate Postoperative and 2 Year Postoperative Period|Vector wear, which is defined as movement (difference of femoral prosthetic head positions) between immediate postoperative and 2 years postoperative periods. There is no lower and upper limit, actual measured results. The outcome can be negative value.|Immediate postoperative and 2 year postoperatively|Participants, whose x-ray taken at 2 year follow-up visit being available.|||millimeter||Standard Deviation|Mean
2627924|NCT01883453|Primary|Reducing Symptoms of a Common Cold|"Using the Wisconsin Upper Respiratory Symptom Score (WURSS-21)it is possible to assess if a nasal spray containing glucose oxidase and glucose would be able to reduce symptoms of a common Cold.~WURSS 21 is a validated tool of calculating the degree of common Cold symptoms. It consists of 21 questions (20 questions are possible to evaluate) which are graded from 0 to 7 (worst degree of symptoms). These 20 questions (sum of all symptoms) are evaluated every day, Min value is thus 0 and max value/person/day is 140. It is thus possible to calculate the mean value of sum of symptoms for each day in the both groups."|One week|Only the participants that fullfilled the study and who had a positive virus sample (Influensa and adenoviruses excluded) were included in the results. These are the participants that are supposed to benefit from a nasal spray with GO.|||units on a scale||Full Range|Mean
2627925|NCT01883440|Primary|Sum of All Symptoms of All Persons That Fullfilled the Study|"Symptoms of a common cold, recorded in a home protocol, Wisconsin Upper Respiratory Symptom Score 21 (WURSS21) daily for 7 days was used as the evaluation method of the treatment. WURSS-21 is a validated protocol for assessing symptoms of a common cold. We used this protocol at start, before the persons in the study started their treatment and thereafter every day for the next 7 days. WURSS 21 consists of 21 questions (last question is not valid) regarding different symptoms as: running nose, sore throat, cough, blocked nose, etc. Every such question is graded from 0-7, 0 is defined as no such symptom and the number 7 means the worst possible symptom. The outcome measure is predominantly calculated as the sum of all symptoms in the WURSS-21 protocol, which means that the value from each of the 20 questions (min=0, max=140) is summarized every day for each of the participants, which gives a mean value for both groups every day."|7 days|All of the persons that fullfilled the study|||units on a scale||Full Range|Mean
2627926|NCT01883440|Primary|Sum of All Symptoms in Viruspositive Persons|"Symptoms of a common cold, recorded in a home protocol, Wisconsin Upper Respiratory Symptom Score 21 (WURSS21) daily for 7 days was used as the evaluation method of the treatment. WURSS-21 is a validated protocol for assessing symptoms of a common cold. We used this protocol at start, before the persons in the study started their treatment and thereafter every day for the next 7 days. WURSS 21 consists of 21 questions (last question is not valid) regarding different symptoms as: running nose, sore throat, cough, blocked nose, etc. Every such question is graded from 0-7, 0 is defined as no such symptom and the number 7 means the worst possible symptom. The outcome measure is predominantly calculated as the sum of all symptoms in the WURSS-21 protocol, which means that the value from each of the 20 questions (min=0, max=140) is summarized every day for each of the participants, which gives a mean value for both groups every day."|One week|The persons analyzed were those that had a positive viral sampling with Parainfluenza, Corona or Rhinoviruses, that is: the viruses that most often causes common cold and also would be accessible for treatment with a nasal spray.|||units on a scale||Full Range|Mean
2627927|NCT01883427|Primary|Respiratory Infectious Symptoms|Days with upper respiratory tract infection symptoms during a 3 months period are recorded in a home protocol by the parents of the children.|3 months of recording|Only a total of 40 Children fulfilled the study, which means that the Power are to low.|||days||Standard Deviation|Mean
2627928|NCT01883141|Secondary|Within Patient Variability in Positive LV dP/dt Max|Evaluate the within patient variability in positive LV dP/dt max measurements. The standard deviation of the percentage change LV dP/dt max between pacing configurations will be evaluated to obtain information for future sample size calculations for the primary outcome.The standard deviation is summarized over all available subjects and could be used as an estimate of within patient variability for future sample size calculations for the primary outcome.|Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours|Patients underwent an electrophysiological (EP) visit during which multispot, multivein and biventricular (BIV) pacing was performed for each patient. From the 30 eligible patients, 4 patients were excluded from analysis due to EP data collection issues.|||percentage change|||Number
2627935|NCT01882985|Secondary|Time to PSA Progression|The definition of time to PSA progression is the date (after the initiation of chemotherapy on day 2) that a 25% or greater increase, and an absolute increase of 2ng/mL or more, from the nadir PSA is documented. If there is no decrease in PSA following chemotherapy, then PSA progression is the date for documentation of a 25% increase from the baseline value along with an increase in absolute value of 2ng/mL or more.|Up to 4 years|Mean time to PSA progression|||days||Standard Deviation|Mean
2627936|NCT01882985|Secondary|Objective Response Rate as Assessed by RECIST Criteria in Either Visceral or Lymph Node Metastases|The percent of subjects achieving an objective response by RECIST criteria in either visceral or lymph node metastases, and the percent achieving clinical complete disappearance of disease at any site, will be recorded.|Up to 4 years|Data was not collected for this objective.||||||
2627929|NCT01883141|Secondary|Use of Non-invasive Measurements to Identify Pacing Configuration With Highest Positive LV dP/dt Max|Evaluate whether the non-invasive measurements (Nexfin blood pressures) that are also collected during the study can identify the pacing configuration with the highest percentage change LV dP/dt max. For each patient and all time points of data collection, a regression analysis was applied to determine the highest predicted percentage change LV dP/dtmax or percentage change Nexfin pressure per configuration. The Kappa statistic was then determined based on a 7x7 contingency table where the rows and columns corresponded to the pacing configurations. There is no interest in determining the agreement statistics Kappa per time point or per configuration since the interest of this analysis is in the overall agreement between LV dP/dt max and non-invasive measurements.|Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours|From the 30 eligible patients, 4 patients were excluded from analysis due to EP data collection issues and 2 patients were excluded since no blood pressure was collected non-invasively using a Nexfin system.|||Kappa statistic||95% Confidence Interval|Number
2627930|NCT01883141|Secondary|Correlation of Blood Pressure, Electrograms (EGMs) and Electrocardiographic Mapping Measurements With the Positive LV dP/dt Max Values|Correlate blood pressure, EGMs and electrocardiographic mapping measurements with the percentage change LV dP/dt max values obtained during each of the three pacing configurations BiV (BiV distal, BiV mid, BiV proximal, BiV anterior, BiV posterior), MultiVein and MultiSpot. Correlation will be summarized over all pacing configurations and time points since the interest is in the overall correlation between LV dP/dt max and other measurements, not in the correlation per pacing configuration or per time point. A linear mixed effects models as described in Roy, Biometrical Journal 48 (2006) 2, 286- 301 was used for the diastolic and systolic blood pressures. Due to the convergence problems for the linear mixed for Q-LV and QRS, the general linear model as described in Blank & Altman, Biometrical Journal 310 (1995), p 446, was used for Q-LV and QRS.|Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours|Patients underwent an electrophysiological (EP) visit during which multispot, multivein and biventricular (BIV) pacing was performed for each patient. From the 30 eligible patients, 4 patients were excluded from analysis due to EP data collection issues.|||Correlation coefficient|||Number
2627931|NCT01883141|Secondary|Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multi-vein LV Pacing Configuration Compared to Multispot LV Pacing Configuration|Measure the percentage change in positive left ventricular (LV) dP/dt max (mm HG/sec) of multi-vein LV pacing configuration compared to multispot LV pacing in patients undergoing a research study, an electrophysiological exploratory procedure or CRT-implant. The percentage changes correspond to a percentage change between a pacing configuration (pacing on, e.g., Multispot pacing) and baseline (LV pacing off). There are several repetitions of pacing off and on for each pacing configuration. For one repetition, the percentage change is determined as ([median dP/dt max during pacing On] - (median baseline dP/dt max during pacing Off])/[median dP/dt max during pacing Off]. From all percentage changes for a given pacing configuration and subject, a regression analysis is performed to determine the regression predicted highest percentage change. The presented percentage change is the average over all subjects.|Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours|Patients underwent an electrophysiological (EP) visit during which multispot, multivein and biventricular (BiV) pacing was performed for each patient. From the 30 eligible patients, 4 patients were excluded from analysis (EP data collection issues: n = 4).|||percentage change LV dP/dt max||Standard Error|Mean
2627932|NCT01883141|Secondary|Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multi-vein LV Pacing Configuration Compared to Normal Biventricular Pacing|Measure the percentage change in positive left ventricular (LV) dP/dt max (mm HG/sec) of multi-vein LV pacing configuration compared to normal biventricular pacing in patients undergoing a research study, an electrophysiological exploratory procedure or CRT-implant. The percentage changes correspond to a percentage change between a pacing configuration (pacing on, e.g., Multispot pacing) and baseline (LV pacing off). There are several repetitions of pacing off and on for each pacing configuration. For one repetition, the percentage change is determined as ([median dP/dt max during pacing On] - (median baseline dP/dt max during pacing Off])/[median dP/dt max during pacing Off]. From all percentage changes for a given pacing configuration and subject, a regression analysis is performed to determine the regression predicted highest percentage change. The presented percentage change is the average over all subjects.|Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours|Patients underwent an electrophysiological (EP) visit during which multispot, multivein and biventricular (BiV) pacing was performed for each patient. From the 30 eligible patients, 4 patients were excluded from analysis (EP data collection issues: n = 4).|||percentage change LV dP/dt max||Standard Error|Mean
2627933|NCT01883141|Primary|Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multispot LV Pacing Configuration Compared to Normal Biventricular Pacing|Measure the percentage change in positive left ventricular (LV) dP/dt max (mm HG/sec) of multispot LV pacing configuration compared to normal biventricular pacing in patients undergoing a research study, an electrophysiological exploratory procedure or cardiac resynchronization therapy (CRT) implant. The percentage changes correspond to a percentage change between a pacing configuration (pacing on, e.g., Multispot pacing) and baseline (LV pacing off). There are several repetitions of pacing off and on for each pacing configuration. For one repetition, the percentage change is determined as ([median dP/dt max during pacing On] - (median baseline dP/dt max during pacing Off])/[median dP/dt max during pacing Off]. From all percentage changes for a given pacing configuration and subject, a regression analysis is performed to determine the regression predicted highest percentage change. The presented percentage change is the average over all subjects.|Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours|Patients underwent an electrophysiological (EP) visit during which multispot, multivein and biventricular (BiV) pacing was performed for each patient. From the 30 eligible patients, 4 patients were excluded from analysis (EP data collection issues: n = 4).|||percentage change LV dP/dt max||Standard Error|Mean
2627934|NCT01882985|Secondary|Toxicity of Combined Docetaxel + Lycopene Therapy|The percentage of subjects experiencing grade 3-4 hematologic and non-hematologic toxicity will be recorded, as well as the reason for ending treatment. This outcome measure was not collected due to lack of funding.|Up to 4 years|Data was not collected for this outcome measure.||||||
2646947|NCT01699789|Secondary|>=4 Hospital Nights for Behavioral Health||6 months follow-up||||percentage of participants||95% Confidence Interval|Number
2627937|NCT01882985|Primary|Proporation of Subjects Achieving Partial Response, Stable Disease or Progressive Disease Based on PSA Response Rates|To define the prostate-specific antigen (PSA) response rate according to the criteria of Bubley, et al. in subjects treated with a combination of docetaxel and lycopene. Per criteria of Bubley, et al., PSA response rate is defined the number of subjects who achieve a >50% decline in PSA from baseline.|Up to week 12 of therapy|One patient was inevaluable due to lost to follow up and one patient withdrew consent.|||Participants|||Count of Participants
2627938|NCT01882907|Other Pre-specified|the Numbers of Participants With Adverse Events Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks, visit 3,4,5|This number is subject population who were exposure the drug(Vildagliptin group n=117, Pioglitazone group n=111). It is excluded the patients who are screening failure.|||participants|||Number
2627939|NCT01882907|Secondary|the Mean Changes of Insulin, C-peptide, HOMA-IR, HOMA-beta From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks, visit 5|This number is analyzed subjects population(Vildagliptin group n=115, Pioglitazone group n=108). It is excluded the patients who are screening failure and not available to efficacy assessment.|||mcU/mL*mmol/L||Standard Deviation|Mean
2627940|NCT01882907|Secondary|the Mean Changes of Body Weight From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups||16 weeks, visit 5|This number is analyzed subjects population(Vildagliptin group n=115, Pioglitazone group n=108). It is excluded the patients who are screening failure and not available to efficacy assessment.|||kg||Standard Deviation|Mean
2627941|NCT01882907|Secondary|the Mean Changes of Lipid Profiles From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups|The Mean Changes of Lipid Profiles(Triglyceride, Total cholesterol, LDL, HDL, Non-HDL cholesterol) From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups after 16weeks|16 weeks, visit 5|This number is analyzed subjects population(Vildagliptin group n=115, Pioglitazone group n=108). It is excluded the patients who are screening failure and not available to efficacy assessment.|||mg/dL||Standard Deviation|Mean
2627942|NCT01882907|Secondary|the Mean Changes of FPG and PPG From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups|"After 16 weeks, to assess the effect of vildagliptin compared with the effect of pioglitazone on Fasting Plasma Glucose (FPG)~After 16 weeks, to assess the effect of vildagliptin compared with the effect of pioglitazone on Postprandial Glucose (PPG)"|16 weeks , visit 5|This number is analyzed subjects population(Vildagliptin group n=115, Pioglitazone group n=108). It is excluded the patients who are screening failure and not available to efficacy assessment.|||mg/dL||Standard Deviation|Mean
2627943|NCT01882907|Primary|Non-inferiority of HbA1C Change From Baseline in Vildagliptin + Metformin Group Compared With Pioglitazone + Metformin Group||16 weeks|This number is analyzed subjects population(Vildagliptin group n=115, Pioglitazone group n=108). It is excluded the patients who are screening failure and not available to efficacy assessment.|||% (change of HbA1c)||Standard Deviation|Mean
2627944|NCT01882868|Secondary|Volume of Distribution at the Steady State (Vss) for Irinotecan: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of irinotecan in combination with aflibercept and 5-FU in Cycle 1.|Predose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||liter||Standard Deviation|Mean
2627945|NCT01882868|Secondary|Total Body Clearance (CL) for Irinotecan: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of irinotecan in combination with aflibercept and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||liter/hour||Standard Deviation|Mean
2627946|NCT01882868|Secondary|Active Metabolite SN-38 / Irinotecan Ratio on Area Under the Concentration Time Curve (Rmet): Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non - compartmental PK analysis of irinotecan and SN-38 in combination with aflibercept and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.|||ratio||Standard Deviation|Mean
2627947|NCT01882868|Secondary|Terminal Elimination Half-life (t1/2z) for Irinotecan and Its Active Metabolite SN-38: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of irinotecan and SN-38 in combination with aflibercept and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.|||hours||Standard Deviation|Mean
2627948|NCT01882868|Secondary|Area Under the Concentration Time Curve (AUC) for Irinotecan and Its Active Metabolite SN-38: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of irinotecan and SN-38 in combination with aflibercept and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.|||ng*h/mL||Standard Deviation|Mean
2628310|NCT01879072|Primary|Number of Participants Providing Biologic Samples|The primary outcome will be measured by the number of participants who supply biologic samples. The prospectively collected samples will be a shared bio specimen resource for conducting future correlative studies.|Two years from hematopoietic stem cell transplant||||Participants|||Count of Participants
2627949|NCT01882868|Secondary|Area Under the Concentration Time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Irinotecan and Its Active Metabolite SN-38: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of irinotecan and SN-38 in combination with aflibercept and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||ng*h/mL||Standard Deviation|Mean
2627950|NCT01882868|Secondary|Maximum Observed Plasma Concentration (Cmax) for Irinotecan and Its Active Metabolite SN-38: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of irinotecan and SN-38 in combination with aflibercept and 5-FU in Cycle 1.|Predose (prior to aflibercept infusion), 1.5, 2, 4.5 and 23 hours post irinotecan infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||ng/mL||Standard Deviation|Mean
2627951|NCT01882868|Secondary|Clearance at Steady State (CLss) for 5-FU: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of 5-FU in combination with aflibercept and irinotecan in Cycle 1.|Pre-dose (prior to aflibercept infusion), 2.5, 21 and 45 hours post 5-FU infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||liter/hour||Standard Deviation|Mean
2627952|NCT01882868|Secondary|Steady State Drug Concentration (Css) for 5-FU: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of 5-FU in combination with aflibercept and irinotecan in Cycle 1.|Pre-dose (prior to aflibercept infusion), 2.5, 21 and 45 hours post 5-FU infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||ng/mL||Standard Deviation|Mean
2627953|NCT01882868|Secondary|Terminal Elimination Half-life (t1/2z) for Free Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||days||Standard Deviation|Mean
2627954|NCT01882868|Secondary|Volume of Distribution at the Steady State (Vss) for Free Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||liters||Standard Deviation|Mean
2627955|NCT01882868|Secondary|Total Body Clearance (CL) for Free Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||liter/day||Standard Deviation|Mean
2627956|NCT01882868|Secondary|Area Under the Concentration Time Curve (AUC) for Free Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Pre-dose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis.|||mcg*day/mL||Standard Deviation|Mean
2627957|NCT01882868|Secondary|Area Under the Concentration Time Curve From Time 0 to 14 Days Post Start of Infusion (AUC0-14 Day) for Free and VEGF-Bound Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free and VEGF-bound aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Predose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.|||mcg*day/mL||Standard Deviation|Mean
2627958|NCT01882868|Secondary|Area Under the Concentration Time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Free and VEGF-Bound Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free and VEGF-bound aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Predose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.|||mcg*day/mL||Standard Deviation|Mean
2630588|NCT01853072|Secondary|Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90||Baseline to Day 90|Full analysis set|||Percentage of participants|||Number
2627959|NCT01882868|Secondary|Time to Reach Maximum Plasma Concentration Observed (Tmax) for Free and VEGF-Bound Aflibercept in Cycle 1: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free and VEGF-bound aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Predose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.|||days||Full Range|Median
2627960|NCT01882868|Secondary|Maximum Observed Plasma Concentration (Cmax) for Free and Vascular Endothelial Growth Factor (VEGF)-Bound Aflibercept: Participants With Additional Blood Sampling for Detailed PK Analysis|In 10 participants of ITT population, additional blood samples were obtained for detailed non-compartmental PK analysis of free and VEGF-bound aflibercept in combination with irinotecan and 5-FU in Cycle 1.|Predose (prior to aflibercept infusion), 1, 2, 4, 8, 24, 48, 168 and 336 hours post aflibercept infusion on Day 1 of Cycle 1|Subset of ITT population with additional blood sampling for detailed non-compartmental PK analysis. Number of participants analyzed=participants with PK assessment for the subset analysis. Here 'n' signifies number of participants with available data for specified category.|||mcg/mL||Standard Deviation|Mean
2627961|NCT01882868|Secondary|Volume of Distribution at the Steady State (Vss) for Free Aflibercept: ITT Population|Sparse blood sampling was performed on 52 participants and additional blood sampling for detailed PK analysis was performed on 10 participants as per protocol. A population PK analysis was performed and an overall data is reported for all the participants.|Pre-dose, 1, 4, 24, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with sparse sampling & pre-dose, 1, 2, 4, 8, 24, 48, 168, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with additional sampling|ITT population included all registered participants.|||liters||Standard Deviation|Mean
2627962|NCT01882868|Secondary|Total Body Clearance (CL) for Free Aflibercept: ITT Population|Sparse blood sampling was performed on 52 participants and additional blood sampling for detailed PK analysis was performed on 10 participants as per protocol. A population PK analysis was performed and an overall data is reported for all the participants.|Pre-dose, 1, 4, 24, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with sparse sampling & pre-dose, 1, 2, 4, 8, 24, 48, 168, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with additional sampling|ITT population included all registered participants.|||liter/day||Standard Deviation|Mean
2627963|NCT01882868|Secondary|Area Under the Concentration Time Curve (AUC) for Free Aflibercept: ITT Population|Sparse blood sampling was performed on 52 participants and additional blood sampling for detailed PK analysis was performed on 10 participants as per protocol. A population PK analysis was performed and an overall data is reported for all the participants.|Pre-dose, 1, 4, 24, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with sparse sampling & pre-dose, 1, 2, 4, 8, 24, 48, 168, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with additional sampling|ITT population included all registered participants.|||mcg*day/mL||Standard Deviation|Mean
2627964|NCT01882868|Secondary|Area Under the Concentration Time Curve From Time 0 to 14 Days Post Start of Infusion (AUC0-14 Day) for Free Aflibercept: ITT Population|Sparse blood sampling was performed on 52 participants and additional blood sampling for detailed PK analysis was performed on 10 participants as per protocol. A population PK analysis was performed and an overall data is reported for all the participants.|Pre-dose, 1, 4, 24, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with sparse sampling & pre-dose, 1, 2, 4, 8, 24, 48, 168, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with additional sampling|ITT population included all registered participants.|||mcg*day/mL||Standard Deviation|Mean
2627965|NCT01882868|Secondary|Maximum Observed Plasma Concentration (Cmax) for Free Aflibercept: ITT Population|Sparse blood sampling was performed on 52 participants and additional blood sampling for detailed pharmacokinetic (PK) analysis was performed on 10 participants as per protocol. A population PK analysis was performed and an overall data is reported for all the participants.|Pre-dose, 1, 4, 24, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with sparse sampling & pre-dose, 1, 2, 4, 8, 24, 48, 168, 336 hours post aflibercept infusion on Day 1 of Cycle 1 for participants with additional sampling|Intent-to-Treat (ITT) population included all registered participants.|||mcg/mL||Standard Deviation|Mean
2627966|NCT01882868|Secondary|Aflibercept Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay|Blood samples of participants were analyzed by using a titer-based, bridging immunoassay developed and validated to detect aflibercept ADA in human serum. Samples with positive antibody levels were further analyzed using a validated, non-quantitative, competitive ligand binding assay to detect NAb.|Baseline, at any time post baseline and 90 days after the last dose of aflibercept|The safety population (AT population) included all registered participants who received at least 1 (even if incomplete) infusion of study treatment. Here 'n' signifies number of participants with available data for specified category.|||participants|||Number
2627967|NCT01882868|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on--treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment.|First dose (Day 1 of Cycle 1) of study treatment up to end of treatment visit (30 days after last dose of study treatment) (maximum duration: 77 weeks)|The safety population (AT population) included all registered participants who received at least 1 (even if incomplete) infusion of study treatment.|||participants|||Number
2627968|NCT01882868|Secondary|Overall Survival (OS)|OS was defined as the time interval from the date of first study drug administration to the date of death due to any cause. If death was not observed, the participant was censored at the last date the participant was known to be alive or the study cut-off date, whichever was first. OS was estimated by Kaplan-Meier estimates.|Baseline up to death or study cut--off (maximum duration: 24.7 months)|The safety population (AT population) included all registered participants who received at least 1 (even if incomplete) infusion of study treatment.|||months||95% Confidence Interval|Median
2627969|NCT01882868|Secondary|Progression Free Survival (PFS)|PFS was defined as the time interval from the date of first study drug administration to the date of first observation of DP or death due to any cause, whichever came first. If death or progression was not observed, the participant was censored at the date of participant's last valid progression-free tumor assessment prior to the study cut-off date. DP for PFS was assessed by the IRRC based on tumor imaging according to RECIST 1.1. Progression in disease was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study with absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was estimated by Kaplan-Meier estimates.|Baseline and every 6 weeks until DP or death, due to any cause (maximum duration: 16.4 months)|The safety population (all treated [AT] population) included all registered participants who received at least 1 (even if incomplete) infusion of study treatment.|||months||95% Confidence Interval|Median
2627970|NCT01882868|Primary|Percentage of Participants With Overall Response|Overall response in participants was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) assessed by an independent radiological review committee (IRRC) according to response evaluation criteria in solid tumors (RECIST) version 1.1. CR was defined as disappearance of all target lesions; any lymph node (target or non-target) must have reduction in the short axis to <10 mm; PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentage of participants with overall response and the 95% confidence interval (CI) were provided. The 95% CI was calculated using normal approximation.|Baseline and every 6 weeks until DP (maximum duration: 16.4 months)|EP population: all registered participants with measurable disease at study entry & with at least 1 valid post-baseline tumor evaluation. Participants who died due to DP or had documented radiological progressive disease before first post-baseline imaging evaluation were also included.|||percentage of participants||95% Confidence Interval|Number
2627971|NCT01882829|Secondary|Beck Scale for Suicidal Ideation (BSI)|Mean change in Brief Inventory Symptom from baseline to week 10. The BSS is a self-report 19-item scale preceded by five screening items. The BSS and its screening items are intended to assess a patient's thoughts, plans and intent to commit suicide. All 24 items are rated on a three-point scale (0 to 2). In this study, scores from the five screening items were included in the overall score. Therefore, total scores could range from 0 to 48, with higher scores reflecting more severe symptoms.|Baseline and Week 10||||change in units on a scale||Standard Deviation|Mean
2627972|NCT01882829|Secondary|HAM-A|Change in Hamilton Anxiety Rating Scale (HAM-A) score from baseline to Week 10. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and >25-30 moderate to severe.|Baseline and Week 10||||change in units on a scale||Standard Deviation|Mean
2627973|NCT01882829|Secondary|Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)|The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) is a brief scale to measure cognitive and executive dysfunction in mood and anxiety disorders, and possesses good reliability and validity. The Massachusetts General Hospital CPFQ was developed to assess each of the 7 most common complaints of depressed patients reporting fatigue or cognitive/executive problems. The CPFQ consists of 7 questions, each rated on a scale from 1 to 6, with 1 indicating greater than normal functioning, 2 indicating normal functioning and with higher numbers indicating poorer functioning. Total score range from 7 (greater than normal function) to 42 (poor function).|At baseline and Visit 6 (week 10)||||change in units on a scale||Standard Deviation|Mean
2627974|NCT01882829|Secondary|Clinical Global Impression (CGI) Scale|The Clinical Global Impression (CGI) scale assesses overall treatment response in psychiatric patients and has good reliability and validity metrics. The administration time is 2 minutes. This scale consists of three items: Severity of Illness (item 1); Global Improvement (item 2); and Efficacy Index (item 3). Item 1 is rated on a seven-point scale (1 = normal, 7 = among the most extremely ill patients) as is item 2 (1 = very much improved, 7 = very much worse). Full scale is 1 to 14.|up to 12 weeks||||change in units on a scale||Standard Deviation|Mean
2627975|NCT01882829|Secondary|Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR)|The Quick Inventory of Depressive Symptomatology, Self Report (QIDS-SR) is a 16-item self rated instrument designed to assess the severity of depressive symptoms (30). The 16 items cover the nine symptom domains of major depression, and are rated on a scale of 0-3. Total score ranges from 0 to 27, with ranges of 0-5 (normal), 6-10 (mild), 11-15 (moderate), 16-20 (moderate to severe), and 21+ (severe).|up to 12 weeks||||change in units on a scale||Standard Deviation|Mean
2627976|NCT01882829|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|The Columbia-Suicide Severity Rating Scale (C-SSRS) is a comprehensive, semi-structured interview measure that uniquely measures the full spectrum of suicidality including passive and active suicidal ideation, suicidal intent as well as suicidal behaviors. Full range from 0 (low intensity suicidal ideation to 9 (high intensity suicidal ideation).|up to 12 weeks|missing data on one participant|||change in units on a scale||Standard Deviation|Mean
2627977|NCT01882829|Secondary|Patient Rated Inventory of Side Effects (PRISE)|Frequency of observed adverse events over the study treatment period as captured by the PRISE. The Patient Rated Inventory of Side Effects (PRISE) assesses the presence of treatment side effects in nine organ/function systems (gastrointestinal, nervous system, heart, eyes/ears, skin, genital/urinary, sleep, sexual functioning, and other).|up to 12 weeks||||events|||Number
2627978|NCT01882829|Secondary|Sheehan Disability Scale|The Sheehan Disability Scale (SDS) is a self-rated scale which assesses illness-related disability in three areas of functioning: work, social and family. The SDS assess disability or functional impairment across three domains: work/school, social life/leisure activities and family life/home responsibilities. Each domain is scored from 0 (not at all) to 10 (very severely). The three domains can be summarized to evaluate global functional impairment by adding the scores of each of the three domains, resulting in global SDS score ranges from 0 (unimpaired) to 30 (highly impaired).|At baseline and Visit 6 (week 10)||||change in units on a scale||Standard Deviation|Mean
2628121|NCT01881737|Primary|Number of Participants With Adverse Events According to Dosage Record and Treatment Emergent Symptom (DOTES) as Assessed at All Follow-up Visits (2, 4, 6, 8, 10, 12, and 16 Weeks)||2, 4, 6, 8, 10, 12, and 16 weeks|During the 12-week treatment period, two participants dropped out of the study. The follow-up observations for the two participants who dropped out were included in the analyses.|||participants|||Number
2627979|NCT01882829|Secondary|Range of Impaired Functioning Tool|"The Range of Impaired Functioning Tool a brief scale for assessing functional impairment related to medical or psychiatric illness and has been demonstrated to possess good psychometric properties. The LIFE-RIFT has a total score and individual domain scores for the following areas of functioning: household duties, work, recreation, relationships with family, relationships with friends, schoolwork, and global life satisfaction (the satisfaction item is patient rated).~Higher scores indicate poorer functioning; scores ≥2 reflect impaired functioning in that domain. Results are reported for the total sum with full range from 3 (no impairment) to 60 (severe impairment), which is based on all individual domain scores."|At baseline and Visit 6 (week 10)|missing data on 2 participants|||change in units on a scale||Standard Deviation|Mean
2627980|NCT01882829|Secondary|Quality of Life Enjoyment and Satisfaction Questionnaire Short Form|The Quality of Life Enjoyment and Satisfaction Questionnaire Short Form is a reliable and valid self-report measure designed to obtain sensitive measures of the degree of enjoyment and satisfaction experienced by individuals. The raw total score ranges from 14 to 70. Higher scores reflect better oucomes.|At baseline and Visit 6 (week 10)||||change in units on a scale||Standard Deviation|Mean
2627981|NCT01882829|Primary|Montgomery-Asberg Depression Rating Scale|The Montgomery-Asberg Depression Rating Scale is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is s scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression). Primary outcome is change in MADRS at Visit 6 (Week 10). Higher values represent a worse outcome.|At baseline and visit 6 (week 10)||||change in units on a scale||Standard Deviation|Mean
2627982|NCT01882803|Secondary|Time to Response (TTR)|Time to Response per IRC Full Analysis Set|First dose to first documentation of complete or partial response|Time to Response per IRC Full Analysis Set|||participants|||Number
2627983|NCT01882803|Secondary|PK Plasma Concentrations of Duvelisib and Its Metabolite(s)|Pharmacokinetics - duvelisib concentration (ng/mL) Full Analysis Set|Every 4 weeks for 12 weeks|Pharmacokinetics - duvelisib and IPI-656 concentration (ng/mL) Full Analysis Set|||ng/mL||Full Range|Median
2627984|NCT01882803|Secondary|Overall Survival|Overall Survival Full Analysis Set|Every 16 weeks; for an average survival follow-up of 24 months|Overall Survival Full Analysis Set|||months||95% Confidence Interval|Median
2627985|NCT01882803|Secondary|Progression-free Survival|Progression Free Survival per IRC Full Analysis Set|Every 8-16 weeks; for an average response / progression follow-up of 24 months|Kaplan-Meier Event-Free Estimate (95% Confidence Interval)|||months||95% Confidence Interval|Median
2627986|NCT01882803|Secondary|Duration of Response|Duration of Response per IRC Full Analysis Set|Every 8-16 weeks; for an average duration of response follow-up of 24 months|Duration of Response per IRC Full Analysis Set|||months||95% Confidence Interval|Median
2627987|NCT01882803|Secondary|Number of Subjects With Treatment- Emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values|Treatment-Emergent Adverse Events Occurring in ≥ 10% Subjects, by SOC and PT (FAS)|Every 2-8 weeks; up to 30 days after the last dose of duvelisib.|Subjects with at Least 1 TEAE|||Participants|||Count of Participants
2627988|NCT01882803|Primary|Overall Response Rate (ORR) in All Subjects During Treatment With Duvelisib Based on Standard Response.|Summary of Best Overall Response and Overall Response Rate per IRC Assessment (FAS)|Every 8-16 weeks while on treatment with duvelisib; an expected average on-treatment duration of response follow-up of 24 months|FAS|||Participants|||Count of Participants
2627989|NCT01882764|Primary|The Proportion of Subjects Achieving Clinical Remission|Clinical remission is defined as a modified Mayo Score ≤2 along with no individual score >1 AND rectal bleeding score = 0.|52 weeks||||Participants|||Count of Participants
2627990|NCT01882725|Secondary|Change in Skin Surface Temperature on the Hind Foot|"Skin surface temperature on the hind foot was recorded in degrees using an infrared thermometer. Change in skin surface temperature in degrees was calculated as the change in measurements before the first procedure administration (baseline) to after the sixth and final procedure administration. It was pre-determined that a minimum mean increase in skin surface temperature of +2.5 degrees across the procedure administration phase would be considered clinically meaningful.~A positive (+) change indicates that the skin surface temperature increased across the procedure administration phase and is positive for study efficacy.~A negative (-) change indicates that the skin surface temperature decreased across the procedure administration phase and is negative for study efficacy."|baseline and 3 weeks||||Degrees Farenheit||Standard Deviation|Mean
2627991|NCT01882725|Primary|Change in Skin Perfusion Pressure (SPP)|"Skin Perfusion Pressure (SPP) measured peripheral microcirculation or skin perfusion using a laser Doppler sensor and a pressure cuff to evaluate reactive hyperemia, the transient increase in blood flow that occurs following a brief period of ischemia. The SPP value was measured in mmHg.~The per cent (%) change in mean Skin Perfusion Pressure (SPP) in mmHg was calculated as the % change in measurements from before the first procedure administration with the Erchonia® HPS Laser to after the sixth and final procedure administration. It was pre-determined that a minimum mean change in % SPP of +10% or greater across the evaluation period would be considered clinically meaningful.~A positive (+) change indicates that SPP increased across the procedure administration phase and is positive for study efficacy.~A negative (-) change indicates that SPP decreased across the procedure administration phase and is negative for study efficacy."|baseline and 3 weeks||||percentage of change||Standard Deviation|Mean
2627992|NCT01882647|Other Pre-specified|Change in Percent Body Surface Area (% BSA) With Active Psoriasis at Day 15|The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject's palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area.|Day 15|Analysis shown is based on the Intent-to-Treat (ITT) population at Day 15 and compared to baseline. ITT was defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.|||Change in %BSA||Standard Deviation|Mean
2627993|NCT01882647|Other Pre-specified|Change From Baseline in Pruritus Score at Day 15|Pruritus scale will be used to assess the subjective and multidimensional experience of the subject's pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus).|Baseline and Day 15|Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.|||units on a scale||Standard Deviation|Mean
2627994|NCT01882647|Other Pre-specified|"Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation) at Day 8"|"Interim analysis of clinical signs of psoriasis. Treatment success for each of the clinical signs of psoriasis (scaling, erythema and plaque elevation) at Day 8 as defined in the secondary outcome measure."|Day 8|Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.|||percentage of participants|||Number
2627995|NCT01882647|Other Pre-specified|"Percentage of Subjects With IGA Treatment Success at Day 8"|"Interim analysis of IGA. Treatment success and IGA as defined in the primary outcome measure."|Day 8|Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article. Only participants with observed values are reported.|||percentage of participants|||Number
2627996|NCT01882647|Secondary|"The Percentage of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)"|"A static assessment of the overall or average degree of severity of each of three key characteristics present within all of the subject's psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 15|Analysis shown is based on the Intent-to-Treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.|||percentage of participants|||Number
2627997|NCT01882647|Primary|"The Percentage of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA)"|"The IGA score is a static evaluation of the overall or average degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 15|All subjects were classified into the following datasets: intent-to-treat (ITT), per protocol (PP), and safety populations. Analysis shown is based on the ITT population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.|||percentage of participants|||Number
2627998|NCT01882543|Other Pre-specified|AQX-1125 Concentrations in Plasma and Urine (Trough Values)|AQX-1125 Plasma and Urine Concentrations were measured at week 4 and week 6.|Week 4 and Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||ng/mL||Standard Deviation|Mean
2627999|NCT01882543|Secondary|Voiding Frequency as Recorded by Diary Over a 24 Hour Period|For a 24-hour period (within 3 days of the subsequent visit), subjects recorded the frequency of each void prior to visit. The outcome measure was the change from baseline at week 6.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||number of voids||Standard Error|Mean
2628000|NCT01882543|Secondary|Short Form 12 Version 2.0 Health Survey [SF-12v2] Questionnaire|Change from baseline to week 6 in the SF-12v2 questionnaire. Two parameters, PCS (physical component summary) and MCS (mental component summary) were calculated. Both components scores range from 0 to 100 with higher scores indicating better Quality of Life.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||units on a scale||Standard Error|Mean
2628001|NCT01882543|Secondary|O'Leary-Sant Interstitial Cystitis Symptom Index/Problem Index [ICSI/PI]|Change from baseline to week 6 in the O'Leary Sant Symptom and Problem Index combined total scores. Both the ICSI and ICPI consist of 4 questions with responses for the ICSI rated on a scale of 0-5 (maximum score of 20, with a higher score indicating worse symptoms) and for the ICPI on a scale of 0-4 (maximum score of 16, with a higher score indicating worse symptoms). For the combined ICSI/PI the maximum score is 36, with a higher score indicating worse symptoms.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||units on a scale||Standard Error|Mean
2628002|NCT01882543|Secondary|Bladder Pain/Interstitial Cystitis Symptom Score [BPIC-SS]|Change in baseline to week 6 in the BPIC-SS participant reported questionnaire total score. The total BPIC-SS score ranges from 0-38, with a higher score indicative of worse symptoms. A score of 19 or more was considered to be discriminating between IC/BPS and overactive bladder at screening.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||units on a scale||Standard Error|Mean
2628003|NCT01882543|Secondary|Change From Baseline in the Maximum Bladder Pain Score (Clinic)|Change from baseline to week 6 in the maximum daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded at study visits. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||units on a scale||Standard Error|Mean
2628004|NCT01882543|Secondary|Change From Baseline in the Average Bladder Pain Score (Clinic)|Change from baseline to week 6 in the average daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded at study visit. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||units on a scale||Standard Error|Mean
2628005|NCT01882543|Secondary|Change From Baseline in the Maximum Daily Bladder Pain Score (e-Diary)|Change from baseline to week 6 in the maximum daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded by e-diary. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||units on a scale||Standard Error|Mean
2628207|NCT01880437|Secondary|Percentage of Participants With an Event of Death During the Study||Up to death or 30 days of last dose of study drug (maximum treatment duration = 225 days)|Efficacy analysis population.|||percentage of participants|||Number
2628006|NCT01882543|Primary|Change From Baseline in the Average Daily Bladder Pain Score (e-Diary)|Change from baseline to week 6 in the average daily bladder pain score using a standardized 11-point numerical rating scale (NRS) recorded by e-diary. The 11-point NRS ranges from 0-10 with 0 indicating 'no pain' and 10 indicating 'worst pain'.|Baseline to Week 6|The intent-to-treat analysis population (ITT) is the set of subjects who were randomized and received at least one dose of study medication.|||units on a scale||Standard Error|Mean
2628007|NCT01882465|Primary|Corneal Staining|Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The total was calculated by using the sum across all regions by time point. The range for the total grade for each time point would be 0-20. The total average grade for each lens and time point was evaluated as an average change from baseline level of corneal staining.|20 minutes and 7 hours post lens fitting|All subjects that completed every study visit without a major protocol deviation.|||units on a scale|Subject Eyes|Standard Deviation|Mean
2628008|NCT01882439|Secondary|Change From Baseline in Score Evaluating Spondylitis Using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Months 1, 3, 6|BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 (0=none and 10=very severe) participants answered 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averaged the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug with presence of spondylitis at screening and baseline BASDAI score >0 cm, and were evaluable.|||cm||Standard Error|Least Squares Mean
2628009|NCT01882439|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score: Months 1, 3, 6|"FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (washed out), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue impact on daily functioning. n=number of participants evaluable at each visit."|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
2628010|NCT01882439|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score: Months 1, 3, 6|"FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (washed out), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue experience. n=number of participants evaluable at each visit."|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
2628011|NCT01882439|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score: Months 1, 3, 6|"FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (washed out), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better fatigue status. n=number of participants evaluable at each visit."|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
2628012|NCT01882439|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today: Months 1, 3, 6|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||mm||Standard Error|Least Squares Mean
2628020|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Social Functioning Domain: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher social functioning domain score represents better social functioning. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||T-scores||Standard Error|Least Squares Mean
2628013|NCT01882439|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression: Months 1, 3, 6|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
2628014|NCT01882439|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort: Months 1, 3, 6|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
2628015|NCT01882439|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities: Months 1, 3, 6|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
2628016|NCT01882439|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-Care: Months 1, 3, 6|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
2628017|NCT01882439|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility: Months 1, 3, 6|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
2628018|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Health Domain: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher mental health domain score represents better mental health functioning. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||T-scores||Standard Error|Least Squares Mean
2628019|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-emotional Domain: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 3-item role-emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher role-emotional domain score represents better role-emotional functioning. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||T-scores||Standard Error|Least Squares Mean
2631182|NCT01846728|Secondary|Cold Induced Thermogenesis|The increase in energy expenditure above resting during cold exposure|Baseline and after 3 months of suppression||||kcal||Standard Deviation|Mean
2628021|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Vitality Domain: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher vitality domain score represents better vitality. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||T-scores||Standard Error|Least Squares Mean
2628022|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): General Health Domain: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher general health domain score represents better general health perceptions. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||T-scores||Standard Error|Least Squares Mean
2628023|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Bodily Pain Domain: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher bodily pain domain score represents less bodily pain. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||T-scores||Standard Error|Least Squares Mean
2628024|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-physical Domain: Months 1, 3, 6|SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; & d) accomplishing less. Items in the role-physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher role-physical domain score represents better role-physical functioning. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||T-scores||Standard Error|Least Squares Mean
2628025|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Functioning Domain: Months 1, 3, 6|SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 10 items of the physical functioning scale represent levels & kinds of limitations between extremes of physical activities, including lifting & carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence & extent of physical limitations using a 3-level response continuum. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher physical functioning domain score represents better physical functioning. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||T-scores||Standard Error|Least Squares Mean
2628026|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Component Summary Score: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better mental health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||T-scores||Standard Error|Least Squares Mean
2628035|NCT01882439|Secondary|Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Swollen Joint Count: Month 3|Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling.|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.|||Joints||Standard Error|Least Squares Mean
2628208|NCT01880437|Secondary|Median Overall Survival (OS) Time|OS was defined as the time from start of study drug to death from any cause. OS was estimated using Kaplan-Meier analysis. Participants alive at the last date known to be alive were censored for the analysis.|Up to death or 30 days of last dose of study drug (maximum treatment duration = 225 days)|Efficacy analysis population.|||months||95% Confidence Interval|Median
2628027|NCT01882439|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Component Summary Score: Months 1, 3, 6|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status. n=number of participants evaluable at each visit.|Months 1, 3, 6|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.|||T-scores||Standard Error|Least Squares Mean
2628028|NCT01882439|Secondary|Change From Baseline in the Leeds Enthesitis Index (LEI): Months 1, 3, and 6|Enthesitis is inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assesses enthesitis in 6 sites. Tenderness is recorded as either present (1) or absent (0) for each of the 6 sites, for a total score of 0-6. Higher score indicates greater severity of enthesitis. n=number of participants evaluable at each visit.|Months 1, 3, and 6|All participants who were randomized, received at least 1 dose of study drug with baseline LEI >0, and were evaluable.|||Units of scale||Standard Error|Least Squares Mean
2628029|NCT01882439|Secondary|Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Months 1, 3, and 6|The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. On examination, tenderness is recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis. n=number of participants evaluable at each visit.|Months 1, 3, and 6|All participants who were randomized, received at least 1 dose of study drug with baseline SPARCC Enthesitis Score >0, and were evaluable.|||Units of scale||Standard Error|Least Squares Mean
2628030|NCT01882439|Secondary|Change From Baseline in Dactylitis Severity Score (DSS): Months 1, 3, and 6|Dactylitis is characterized by swelling of the entire finger or toe. The DSS is a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness. n=number of participants evaluable at each visit.|Months 1, 3, and 6|All participants who were randomized, received at least 1 dose of study drug with baseline DSS >0, and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
2628031|NCT01882439|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response: Months 1, 3, and 6|PASI determines psoriasis severity based on lesion severity and percentage of body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, and scaling evaluated separately for the head and neck, upper limbs, trunk, and lower limbs and then rated for each body area according to a 5 point scale: 0=no involvement; 1=slight; 2=moderate; 3=marked; 4=very marked. BSA involvement is the extent (%) of body area affected by psoriasis and is assigned a numerical score: 0=no involvement; 1=0% to 9%; 2=10% to 29%; 3=30% to 49%; 4=50% to 69%; 5=70% to 89%; 6=90% to 100%. In each area, the sum of the severity rating scores is multiplied by the score representing the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of the numbers obtained for each of the 4 body areas is the PASI. PASI75 is defined as a 75% reduction from baseline in PASI. n=number of responders.|Months 1, 3, and 6|All participants who were randomized and received at least 1 dose of study drug with PASI >0 and BSA ≥3% at baseline.|||Percentage of participants|||Number
2628032|NCT01882439|Secondary|Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response: Months 1, 3, and 6|The PGA-PsO is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are rated separately over the whole body according to a 5-point severity scale, scored as 0=none; 1, 2, 3, or 4=most severe. The severity rating scores are summed and the average taken; the total average is rounded to the nearest whole number score to determine the PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). n=number of participants evaluable at each visit.|Months 1, 3, and 6|All participants who were randomized, received at least 1 dose of study drug with baseline PGA-PsO >0, and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
2628033|NCT01882439|Secondary|Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC): Week 2, Months 1, 2, 3, 4, and 6|The PsARC covers 4 measures: Tender joint count, swollen joint count, the Physician's Global Assessment of Arthritis, and the Patient's Global Assessment of Arthritis. The PsARC response is defined as improvement in 2 of 4 items, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement criteria: ≥20% improvement in Physician's Global Assessment of Arthritis; ≥20% improvement in Patient's Global Assessment of Arthritis; ≥30% improvement in tender joint count; and ≥30% improvement in swollen joint count. n=number of responders.|Week 2, Months 1, 2, 3, 4, and 6|All participants who were randomized and received at least 1 dose of study drug.|||Percentage of participants|||Number
2628034|NCT01882439|Secondary|Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Tender/Painful Joint Count: Month 3|Tender/painful joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty eight (68) joints were assessed by a blinded assessor to determine the number of joints that were considered tender or painful.|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.|||Joints||Standard Error|Least Squares Mean
2628113|NCT01881750|Secondary|Family Empowerment Scale Total Score|Higher Scores Mean better/more empowered and lower scores mean worse/less empowered (Range: Minimum = 24; Maximum=170).|Baseline, 12 weeks|Participants with available data.|||score on a scale||Standard Deviation|Mean
2628036|NCT01882439|Secondary|Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Physician's Global Assessment of Arthritis: Month 3|The blinded investigator or qualified assessor assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.|||mm||Standard Error|Least Squares Mean
2628037|NCT01882439|Secondary|Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Global Assessment of Arthritis: Month 3|"Participants answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The participant's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very well) and 100 (very poorly)."|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable|||mm||Standard Error|Least Squares Mean
2628038|NCT01882439|Secondary|Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Assessment of Arthritis Pain: Month 3|Participants assessed the severity of their arthritis pain using a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.|||mm||Standard Error|Least Squares Mean
2628039|NCT01882439|Secondary|Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components: C-reactive Protein (CRP) Levels: Month 3|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable|||mg/L||Standard Error|Least Squares Mean
2628040|NCT01882439|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6|The HAQ-DI assesses the difficulty a patient has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability. Overall score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranged from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. n=number of participants evaluable at each visit.|Week 2 and Months 1, 2, 4, and 6|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.|||Units on scale||Standard Error|Least Squares Mean
2628041|NCT01882439|Secondary|Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6|ACR20 was calculated as a ≥20% improvement from baseline in tender /painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. n=number of responders.|Week 2 and Months 1, 2, 4, and 6|All participants who were randomized and received at least 1 dose of study drug.|||Percentage of participants|||Number
2628042|NCT01882439|Secondary|Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6|ACR70 was calculated as a ≥70% improvement from baseline in tender /painful and swollen joint counts and ≥70% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. n=number of responders.|Week 2 and Months 1, 2, 3, 4, and 6|All participants who were randomized and received at least 1 dose of study drug.|||Percentage of participants|||Number
2628043|NCT01882439|Secondary|Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6|ACR50 was calculated as a ≥50% improvement from baseline in tender /painful and swollen joint counts and ≥50% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. n=number of responders.|Week 2 and Months 1, 2, 3, 4, and 6|All participants who were randomized and received at least 1 dose of study drug.|||Percentage of participants|||Number
2628044|NCT01882439|Primary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Month 3|The HAQ-DI assesses the difficulty a patient has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability. Overall score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranged from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability.|Month 3|All participants who were randomized, received at least 1 dose of study drug, and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
2628045|NCT01882439|Primary|Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Month 3|ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, Health Assessment Questionnaire - Disability Index (HAQ-DI), and C-reactive protein (CRP).|Month 3|All participants who were randomized and received at least 1 dose of study drug.|||Percentage of participants|||Number
2633475|NCT01824446|Primary|AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||ng equivalents*hr/g||Standard Deviation|Mean
2628046|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 and an Ocular Surface Disease Index® (OSDI®) > 12, > 22 and ≥ 32|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time to 4=all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).|Up to 60 Days Prior to Surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.|||percentage of participants|||Number
2628047|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade ≥ 1 and ≥ 2|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Corneal Staining was evaluated as part of the slit lamp biomicroscopy examination. Eye structures and surfaces were assessed for signs of dry eye using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe. Higher values represent a worse outcome.|Up to 60 Days Prior to Surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.|||percentage of participants|||Number
2628048|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With Punctal Plugs|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. A history of punctual plug usage was assessed by the investigator.|Up to 60 Days Prior to Surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.|||percentage of participants|||Number
2628049|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 Who Routinely Use Artificial Tears|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Artificial Tear usage was assessed by the investigator.|Up to 60 Days Prior to Surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.|||percentage of participants|||Number
2628050|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign and Dry Eye Symptoms|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry Eye Signs included conjunctival or corneal staining, Schirmer's score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds with Dry eye symptoms measured by a score of at least ≥ 2 using the SESoD questionnaire. The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.|||percentage of participants|||Number
2628051|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign Without Dry Eye Symptoms|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry Eye Signs included conjunctival or corneal staining, Schirmer's score ≤ 7 mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds without Dry eye symptoms measured by a score of at least ≤ 1 using the SESoD questionnaire. The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.|||percentage of participants|||Number
2628052|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Any Signs|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry eye symptoms were measured by a score of at least ≥ 2 using the SESoD questionnaire without any signs. The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. Signs included conjunctival or corneal staining, Schirmer's score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.|||percentage of participants|||Number
2628053|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Conjunctival or Corneal Staining|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry eye symptoms were measured by a score of at least ≥ 2 using the Subject Evaluation of Symptoms of Dryness (SESoD) questionnaire without conjunctival or corneal staining. The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. Conjunctival and Corneal Staining were evaluated as part of the slit lamp biomicroscopy examination. Eye structures and surfaces were assessed for dry eye signs using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe. Higher values represent a worse outcome.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.|||percentage of participants|||Number
2628054|NCT01882413|Secondary|Percentage of Participants With Elevated MMP-9 Without Prior Diagnosis or Physician Recommended Intervention|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Participants without a prior diagnosis of keratoconjunctivitis sicca, dry eye or tear film insufficiency or physician recommended use of topical cyclosporine, artificial tears or punctal plugs are included in the analysis.|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated MMP-9 and data available for analysis.|||percentage of participants|||Number
2628114|NCT01881750|Secondary|Parenting Stress Index Total Score|Higher Scores Mean higher stress level and lower scores mean less stress (Range: Minimum = 36; Maximum=180).|Baseline, 12 weeks|Participants with available data.|||score on a scale||Standard Deviation|Mean
2628816|NCT01873495|Primary|Maintenance Toxicities|Toxicities will be monitored by history, physical examination, and laboratory monitoring during maintenance.|24 weeks|No patients entered the maintenance phase of this study.||||||
2628055|NCT01882413|Secondary|Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9|"Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Suspected of having dry eye was defined as a response of Yes to the Investigator Dry Eye History question."|Up to 60 days prior to cataract surgery|Participants from the Per-protocol population, all enrolled participants who completed all the study assessments without major protocol violations, with elevated data MMP-9 and data available for analysis.|||percentage of participants|||Number
2628056|NCT01882413|Primary|Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye|Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.|Up to 60 Days Prior to Surgery|Per-protocol population included all enrolled participants who completed all the study assessments without major protocol violations.|||percentage of participants|||Number
2628057|NCT01882257|Other Pre-specified|Identify Clinical Features That Are Predict or Are Associated With the Severity of Sleep-disordered Breathing|Clinical features (neck and waist circumference, body mass index, level and duration of spinal cord injury, lung function tests, questionnaire results) will be analyzed to determine if certain attributes predict the presence or severity of sleep-disordered breathing.|Month 4 after enrollment|||||||
2628058|NCT01882257|Other Pre-specified|Short Term Effects of Noninvasive Ventilatory Support on Glucose and Lipid Metabolism|When home-based sleep testing is performed, and at 3, 6, and 12 months afterward, subjects will have blood tests to determine if treatment of sleep-disordered breathing has any effects on glucose intolerance/diabetes and/or blood cholesterol/lipid levels|Months 4-16|||||||
2628059|NCT01882257|Other Pre-specified|Short Term Effects of Noninvasive Ventilatory Support on Quality of Life|At month 4 of the study, and every 3 months therafter for 12 months, the subjects will complete standardized questionnaires on quality of life, focusing on general well being, mood, pain, and sleepiness.|Months 4-16|||||||
2628060|NCT01882257|Other Pre-specified|Short Term Effects on Daily Symptoms and Medical Events|The subjects keep daily logs of certain symptoms and events (pulmonary symptoms that require escalated care, pulmonary infections, doctor visits, hospitalizations, antibiotic use, symptoms of unstable blood pressure). These data are collected throughout the study period|Months 0-16 after enrollment|||||||
2628061|NCT01882257|Primary|The Frequency of Technical Errors Related to the Home-based Overnight Testing.|All testing was done overnight, and if the home-based overnight test was inadequate, that portion of the testing was repeated (also overnight).|Overnight testing (4-13 hours)||||participants|||Number
2628062|NCT01882257|Primary|Prevalence of Sleep-disordered Breathing in Spinal Cord-injured Adults|After enrollment, the subject completes symptom logs for four months to collect baseline data. At that point, the home-based sleep study is performed, and the results determine whether the subject has sleep-disordered breathing. The primary outcome to be measured in this study is to determine the prevalence and type of sleep-disordered breathing in subjects with spinal cord injury. These results in turn determine the type of positive pressure device to be prescribed, as detailed in the description of the study arms. Therefore, the arm distribution is itself a primary outcome of this study.|Month 4 after enrollment||||participants|||Number
2628063|NCT01882088|Other Pre-specified|Stools Per Week|Episodes of stools were calculated during 7-day period. Mean number at the end point was compared to the baseline one|7 days|36 patients were enrolled, complete data of 30 of them were available for the final analysis|||stools per week||Standard Deviation|Mean
2628064|NCT01882088|Other Pre-specified|Mean Lower Esophageal Sphincter Pressure (at Rest)|This parameter is obtained with the use of high-resolution esophageal manometry performed on the Day 10 of psyllium intake.|End of Treatment, on day 10 of psyllium intake|36 subjects were enrolled, data of 30 of them were available for the final analysis|||mm Hg||Standard Deviation|Mean
2628065|NCT01882088|Secondary|Residual Lower Esophageal Sphincter Pressure|These data are obtained during high resolution esophageal manometry studies. The end of treatment characteristics were compared to the baseline ones.|End of Treatment, on day 10 of psyllium intake|36 non-erosive reflux disease (NERD) patients were enrolled, the data of 30 of them were available for the final analysis|||mm Hg||Standard Deviation|Mean
2628066|NCT01882088|Secondary|Minimal Resting Lower Esophageal Sphincter (LES) Pressure After 10 Water Swallows|The results obtained during high resolution esophageal manometry studies. This parameter is obtained after 10 water swallows by 5 ml each. Data of high resolution esophageal manometry (examination usually lasts for 10-20 min) on the day 10 of psyllium intake were compared to the baseline characteristics. The data were compared to baseline characteristics|End of Treatment, on day 10 of psyllium intake|36 patients were enrolled, data of 30 of them were available for the final analysis|||mm Hg||Standard Deviation|Mean
2628067|NCT01882088|Secondary|Mean Resting Lower Esophageal Sphincter (LES) Pressure After 10 Water Swallows at the End of Treatment (the Day 10 of Psyllium Intake)|The data are obtained during high resolution esophageal manometry study on the day 10 of psyllium intake. This outcome is measured after 10 water swallows by 5 ml each. The study usually lasts for about 15 to 20 minutes. Data of high-resolution esophageal manometry examination at baseline and on the day 10 of psyllium intake were compared.|End of Treatment, on day 10 of psyllium intake|36 patients enrolled, data of the 30 of them were available for the final analysis|||mm Hg||Standard Deviation|Mean
2628068|NCT01882088|Secondary|Minimal Lower Esophageal Sphincter Pressure at Rest|Obtained during esophageal high resolution manometry study. End of treatment data were compared to the baseline. Per standard, resting pressure is measured during 30 seconds. High resolution manometry data on day 10 was compared to baseline.|End of Treatment, on day 10 of psyllium intake|36 patients were enrolled. data of the 30 of them were available for the final analysis|||mm Hg||Standard Deviation|Mean
2628069|NCT01882088|Secondary|Number of Patients Experiencing Heartburn During 7 Days Prior the Day 10 of Psyllium Intake|Presence of heartburn during 7 days prior to the day 10 of psyllium intake was evaluated with a standardized questionnaire. This result was assessed at EOT|7 days prior to EOT|36 patients were enrolled, data of 30 of them were included to the final analysis|||Number of participants|||Number
2628115|NCT01881750|Primary|Change From Baseline in Communication During Structured Lab Observation (SLO) at 12 Weeks|Total frequency of child's utterances during 10 minute videotaped SLO assessment.|Baseline, 12 weeks|Participants with available data.|||Utterances||Standard Deviation|Mean
2634727|NCT01810263|Primary|Modified Barthel Index (MBI) Score at 6 Months|Scale range: 0-100 (higher values represent a better outcome)|6 months||||units on a scale||Standard Deviation|Mean
2628070|NCT01882088|Secondary|Number of Acid Gastroesophageal Refluxes|Number of acid refluxes was measured by 24-hours oesophageal pH-impedance recordings. Reflux was considered as acid when oesophageal pH was less than 4 and the impedance revealed backward flow of the stomach content into the oesophagus. Outcome measure reflects the data of day 10 of psyllium intake. Statistics reflects comparison between EOT and baseline data.|End of Treatment, on day 10 of psyllium intake|36 subjects were enrolled, data of 30 of them were included to the final analysis|||acid refluxes||Standard Deviation|Mean
2628071|NCT01882088|Secondary|Acid Exposure Time|Percent of time with pH less than 4 at 5 cm above upper border of lower oesophageal sphincter per 24-hours oesophageal pH-impedance recording on the day 10 of psyllium intake. This outcome measure was compared to the baseline characteristics provided in the specific section of the study description|End of Treatment, on day 10 of psyllium intake|Thirty-six patients were enrolled, complete data from 30 were included in the final analysis.|||Percent of time pH<4 per 24-hours period||Standard Deviation|Mean
2628072|NCT01882088|Primary|Number of Gastroesophageal Refluxes|Number of gastroesophageal refluxes registered with 24-hours esophageal pH-impedance on the 10th day of psyllium intake. Statistical data represent the results of the comparison of the data obtained on the day 10 of study (EOT) with the baseline characteristics provided in the specific section|End of Treatment, on day 10 of psyllium intake|Thirty-six patients were enrolled, complete data from 30 were included in the final analysis.|||refluxes||Standard Deviation|Mean
2628073|NCT01882062|Secondary|Correlation Between Primary Outcome Measure and Clinical Parameters|Correlating an improvement of brain energy profile with clinical parameters in Huntington patients such as the Unified Huntington's disease rating scale (UHDRS) and total functional capacity score (TFC).|visit 1 (baseline), visit 2 (after 1 month of treatment)||2015-12-31|12/2015||||
2628074|NCT01882062|Primary|Ratio of Inorganic Phosphate (Pi) Over Phosphocreatine (PCr): Pi/PCr|"The Pi/PCr Ratio is a measure of brain metabolism and it is an index of mitochondrial oxidative regulation.~A 6-cm 31P transmit/receive surface coil (RAPID Biomedical GmbH, Rimpar, Germany) was used to collect free induction decays for 4 minutes at rest, 8 minutes during visual activation with 6-Hz red/black checkerboard flashes, and 8 minutes after stimulation. Subjects were able to focus on the flashes with a nonmagnetic mirror mounted above their eyes while all lights in the room were turned off. The Pi/PCr ratio was then calculated to determine brain response to cortical activation."|visit 1 (baseline), visit 2 (after 1 month of treatment)||||ratio||Standard Deviation|Mean
2628075|NCT01881984|Secondary|Pharmacokinetic (pK)Analysis|Results from the pharmacokinetic (pK)analysis (the rate of conversion of the phenylbutyrate to phenylacetate) will also be reviewed to assess for changes pre- and post-dosing with Ravicti as well as changes in these levels at the different doses of Ravicti.|7 weeks|Due to the small sample size in this Phase I study, details on the analysis cannot be provided due to concerns with subject confidentiality.||||||
2628076|NCT01881984|Primary|Metabolic Stress|Changes in the assessments of metabolic stress pre- and post-dosing with Ravicti will be the main outcome variable.|7 weeks|Due to the small sample size in this Phase I study, details on the analysis cannot be provided due to concerns with subject confidentiality.||||||
2628077|NCT01881932|Primary|Proportion of Colorectal and Breast Cancer Patients in Each Arm Who Require Dose Reduction or Discontinuation Due to Chemotherapy-induced Peripheral Neuropathy.|The main objective is to assess efficacy and safety of acupuncture using Seirin acupuncture needles in colorectal and breast cancer patients who developed chemotherapy-induced peripheral neuropathy while receiving adjuvant/neoadjuvant chemotherapy. Safety will be assessed by recording side effects from acupuncture treatment. Efficacy will be assessed by measuring the proportion of patients in each arm who are required to undergo dose reduction or discontinuation due to chemotherapy-induced peripheral neuropathy.|Week 12|Zero participants analyzed due to early termination of study.||||||
2628078|NCT01881867|Secondary|Overall Survival|Number of participants that have survived|Up to 5 years||||Participants|||Number
2628079|NCT01881867|Secondary|Change in Vaccine-induced Antigen-specific Antibody Immune Response to Prostatic Acid Phosphatase (PAP)|Will be measured by change in immunoglobulin G (IgG) and immunoglobulin M (IgM) levels quantified by standard enzyme-linked immunosorbent assay (ELISA). Fold change from baseline in week 6 titer|Baseline to up to week 6|Participants who provided blood samples to test for antibody levels to PAP|||fold change||Full Range|Median
2628080|NCT01881867|Secondary|Change in Prostate Specific Antigen (PSA) Kinetics.|The change in prostate specific antigen (PSA) kinetics will be evaluated according to the recommendations from PSA Working Group (PSAWG). Analysis of PSA doubling time|Baseline to up to week 53|Study participants who provided blood for PSA testing and analysis|||Weeks||95% Confidence Interval|Mean
2628081|NCT01881867|Secondary|Change in Number of Peripheral Blood Mononuclear Cell (PBMC) Subsets and T Lymphocyte Subsets|The absolute fold change from baseline of CD3+ cells|Week 11|Subjects for whom whole blood was collected at protocol specified timepoints|||fold change||Standard Deviation|Mean
2628082|NCT01881867|Secondary|Change in Circulating Tumor Cells|Enumerated by the approved Veridex assay.|Baseline to up to week 53|Cohort 1: 16 subjects analyzed at Week 01 and 8 subjects analyzed at Week 53. Cohort 2: 22 subjects analyzed at Week 01 and 5 subjects analyzed at Week 53.|||Circulating Tumor Cells||Standard Deviation|Mean
2628083|NCT01881867|Secondary|Change in Bystander Antigen Specific Immune Responses, Measured by Interferon Gamma Production in Response to Various Antigens as Quantified by Enzyme-linked Immunospot (ELISPOT)|Bystander antigen specific immune responses will be assessed to other ongoing and nascent antitumor responses (e.g., preferentially expressed antigen in melanoma, cancer/testis antigen 1B and/or tumor protein p53), additional tumor antigens specific to prostate cancer (e.g., prostate specific antigen [PSA] and/or prostate-specific membrane antigen), and memory viral responses (influenza A and cytomegalovirus, Epstein-Barr virus and influenza virus-derived peptides) using the interferon gamma ELISPOT assay.|Baseline to up to week 53|No subjects were tested for bystander antigen specific immune responses because there was no indication that there was an enhanced response in the primary objective.||||||
2628116|NCT01881737|Secondary|Pregnenolone Level in Peripheral Blood as Measured at Baseline and After 12 Weeks||12 weeks|During the 12-week treatment period, two participants dropped out of the study. The follow-up observations for one of the participants who dropped out were included in the analyses.|||ng/ml||Standard Deviation|Mean
2628117|NCT01881737|Secondary|Repetitive Behavior Scale||12 weeks|Data were not collected for this Outcome Measure because the total score is not a very valid measure of receptive behaviors.||||||
2628084|NCT01881867|Primary|Quantification of T-cell Responses to Prostatic Acid Phosphatase Granulocyte-macrophage Colony-stimulating Factor (PAP-GM-CSF), Assessed by Quantification of Interferon Gamma Levels Measured Using Enzyme-linked Immunospot (ELISPOT)|The Mann-Whitney-Wilcoxon (MWW) test will be used as part of the statistical analysis to determine quantification of T-cell responses to prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor (PAP-GM-CSF), as assessed by quantification of interferon gamma levels measured using enzyme-linked immunospot (ELISPOT). The power is roughly equivalent to that based on the t-test.|Day 70 (week 11)||||T cell spots per 300,000 PBMC||Standard Deviation|Mean
2628085|NCT01881828|Other Pre-specified|Change in Vascular Dysfunction||0-26 weeks|||||||
2628086|NCT01881828|Other Pre-specified|Change in C-peptide|Measured with mixed meal tolerance test among participants with evidence of residual C-peptide on a non-fasting C-peptide at screening|0-26-weeks|||||||
2628087|NCT01881828|Other Pre-specified|Change in Androgen Levels in Females||0-26 weeks|||||||
2628088|NCT01881828|Other Pre-specified|Change in Adipocytokines||0-26 weeks|||||||
2628089|NCT01881828|Other Pre-specified|Frequency of Lactic Acidosis||26 weeks|||||||
2628090|NCT01881828|Other Pre-specified|Frequency of Gastrointestinal Side-effects Including Stomach Discomfort, Diarrhea, Nausea/Vomiting, Indigestion, Flatulence.||26 weeks|||||||
2628091|NCT01881828|Other Pre-specified|Frequency of Diabetic Ketoacidosis||26 weeks|||||||
2628092|NCT01881828|Other Pre-specified|Frequency of Severe Hypoglycemia||26 weeks|||||||
2628093|NCT01881828|Other Pre-specified|Change in Liver Enzymes and Serum Creatinine||0-26 weeks|||||||
2628094|NCT01881828|Secondary|Change in Blood Pressure||0-26 weeks||||mm Hg||95% Confidence Interval|Mean
2628095|NCT01881828|Secondary|Change in Serum Lipids||0-26 weeks||||mg/dL||95% Confidence Interval|Mean
2628096|NCT01881828|Secondary|Change in Body Composition|Change in percent body fat|0-26 weeks||||percentage of change||95% Confidence Interval|Mean
2628097|NCT01881828|Secondary|Change in Waist Circumference||0-26 weeks||||centimeters||95% Confidence Interval|Mean
2628098|NCT01881828|Secondary|Change in Body Mass Index (BMI)||0-26 weeks||||percentile||95% Confidence Interval|Mean
2628099|NCT01881828|Secondary|Change in Total Daily Dose of Insulin (TDI) Per kg||0-26 weeks||||insulin per kg||95% Confidence Interval|Mean
2628100|NCT01881828|Primary|Change in Hemoglobin A1c From Baseline to 26 Weeks, Adjusted for Baseline Hemoglobin A1c.|Hemoglobin A1c is a measure of glycemic control over approximately the past 3 months|0-26 weeks||||percentage of participants|||Number
2628101|NCT01881828|Primary|Change in Hemoglobin A1c From Baseline to 26 Weeks, Adjusted for Baseline Hemoglobin A1c.|Hemoglobin A1c is a measure of glycemic control over approximately the past 3 months|0-26 weeks||||percentage||95% Confidence Interval|Mean
2628102|NCT01881776|Other Pre-specified|Total Hours of Sleep|To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using sleep duration.|first postoperative week (on day 7)||||hours||Standard Deviation|Mean
2628103|NCT01881776|Other Pre-specified|Time to Discharge Home|To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using time-to-discharge home.|throughout the first postoperative week (how long patients stayed in the hospital (includes PACU and hospital time)||||minutes||Standard Deviation|Mean
2628104|NCT01881776|Other Pre-specified|Length of PACU Stay|To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using length of PACU stay.|throughout the first postoperative week (how long patients stayed in PACU just after the operation)||||minutes||Standard Deviation|Mean
2628105|NCT01881776|Other Pre-specified|Fast-tracked Postoperative Care Unit (PACU) Bypass Patient Number|To compare the recovery profile of patients receiving CISB, SISB, or GA for arthroscopic rotator cuff repair surgery throughout the first postoperative week by using fast-tracked PACU bypass rate|throughout the first postoperative week (how many patients left PACU immediately just after the operation)||||participants|||Number
2628106|NCT01881776|Secondary|The Number of Patients Consume ≥1 Dose of Analgesics|The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (analgesic consumption).|throughout the first postoperative week||||participants|||Number
2628107|NCT01881776|Secondary|Time-to-first Pain|The effects of the three anesthetic techniques (SISB, CISB, and GA) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (time-to-first pain).|throughout the first postoperative week||||hours||Standard Deviation|Mean
2628108|NCT01881776|Primary|Patients With Pain: Numerical Rating Scale (NRS-11(0-10): 0:no Pain and 10:Severe/Worst Pain) ≥ 4|The effects of the three anesthetic techniques (continuous interscalene brachial plexus block (CISB), single interscalene brachial plexus block (SISB), or general anesthesia (GA)) when used intraoperatively as a sole anesthesia modality were studied on postoperative pain (highest NRS pain rating)|throughout the first postoperative week on days 1, 2, 3, and 7||||participants|||Number
2628109|NCT01881750|Secondary|Pediatric Quality of Life Scale Scaled Total Mean Score|Higher scores mean better quality of life and lower scores mean worse quality of life (Range: Minimum=0; Maximum=100).|Baseline, 12 weeks|Participants with available data.|||score on a scale||Standard Deviation|Mean
2628110|NCT01881750|Secondary|Sensory Profile Questionnaire Sensory Seeking Raw Score|Higher scores mean more typical sensory seeking behaviors and lower scores mean more abnormal sensory seeking behaviors (Range: Minimum=0; Maximum=85).|Baseline, 12 weeks|Participants with available data.|||score on a scale||Standard Deviation|Mean
2628111|NCT01881750|Secondary|Repetitive Behavior Scale- Revised Total Score|Higher total scores mean more repetitive behaviors and lower total scores mean fewer repetitive behaviors (Range: Minimum=0; Maximum=129).|Baseline, 12 weeks|Participants with available data.|||score on a scale||Standard Deviation|Mean
2628112|NCT01881750|Secondary|Behavior Rating Inventory of Executive Function- Preschool Global Executive Composite Score|Higher scores indicate worse executive functioning and lower scores indicate better executive functioning (Range: Minimum=63; Maximum=189).|Baseline, 12 weeks|Participants with available data.|||score on a scale||Standard Deviation|Mean
2628122|NCT01881620|Secondary|Intra-observer Reproducibility of Injected CT Scanat a Patient Level|The reproducibility of the injected CT scan was evaluated globally for each patient. The same radiologist evaluated the two injected CT scans (CT1 and CT2) and interpreted them (Presence of suspicious lesion(s) OR presence of dubious lesion(s) OR absence of suspicious and dubious lesion). Intra-observer reproducibility was analyzed by using the individual analysis by each radiologist. A weighted Kappa concordance coefficient was calculated using a methodology identical to that described for the evaluation of the proncipal endpoint. Interpretation of CT1 was performed befor inclusion. Interpretation of CT2 was performed at the end of the study.|1 year||||Weighted Kappa concordance coefficient||95% Confidence Interval|Number
2628123|NCT01881620|Secondary|Intra-observer Reproducibility of Injected CT Scan by Anatomical Regions|For each anatomical region, the reproducibility of the injected CT scan was evaluated. The same radiologist evaluated the two injected CT scans (CT1 and CT2) and interpreted them (Presence of suspicious lesion(s) OR presence of dubious lesion(s) OR absence of suspicious and dubious lesion). Intra-observer reproducibility was analyzed by using the individual analysis by each radiologist. A weighted Kappa concordance coefficient was calculated per anatomical region using a methodology identical to that described for the evaluation of the proncipal endpoint. Interpretation of CT1 was performed befor inclusion. Interpretation of CT2 was performed at the end of the study.|1 year||||Weighted Kappa concordance coefficient||95% Confidence Interval|Number
2628124|NCT01881620|Secondary|Inter-observer (N1 and B2) Reproducibility of the PET-CT at a Patient Level|The inter-observer reproducibility of combined PET-CT interpretations has been assessed globally for each patient. The nuclear physician alone (N1) and the independent pair (B2) interpreted the PET-CT examination independently in a global way and concluded for each patient. The inter-observer reproducibility has been evaluated at patient level by comparing the interpretations of the nuclear physician alone and that one of independent pair of nuclear physician and radiologist, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.]. Interpretation by nuclear physician alone (N1) was performed within 1 week of PET-CT examination. Interpretation by B2 was performed at the end of the study|1 year|Interpretation by nuclear physician alone was not performed for 1 patient. Interpretation by the pair of observor B2 was incomplete for 1 patient because 9 area from thorax region were not assessed.|||Weighted kappa concordance coefficient||95% Confidence Interval|Number
2628125|NCT01881620|Secondary|Inter-observer (N1 and B2) Reproducibility of the PET-CT by Anatomical Regions|For each of the 5 anatomical régions (thorax, abdomen, pelvis, bone, nervous system), we evaluated the reproducibility between the interpretations of the PET-CT by the nuclear physician alone (N1) and the independent pair (B2) composed by one nuclear physician and one radiologist . The nuclear physician alone (N1) and the independent pair (B2) interpreted the PET-CT examination independently and described each anatomical region.The inter-observer reproducibility has been evaluated for each anatomical region by comparing the interpretations of the nuclear physician alone and that one of independent pair of nuclear physician and radiologist, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.].Interpretation by nuclear physician alone (N1) was performed within 1 week of PET-CT examination. Interpretation by B2 was performed at the end of the study|1 year|Interpretation by nuclear physician alone was not performed for 1 patient|||Weighted kappa concordance coefficient||95% Confidence Interval|Number
2628126|NCT01881620|Secondary|Inter-observer (B1 and B2) Reproducibility of the PET-CT at a Patient Level|The inter-observer reproducibility of combined PET-CT interpretations has been assessed globally for each patient. Same pairs of observer (B1 and B2) than for the primary endpoint evaluation interpreted the PET-CT examination in a global way and concluded for each patient. A weighted Kappa coefficient has been calculated from an identical methodology to that described for the primary endpoint evaluation. Interpretation by B1 was performed at least 1 month and 1 week after PET-CT examination. Interpretation by B2 was performed at the end of the study|1 year|Reproducibility was not calculated for 1 patient because 9 area from thorax region were not assessed by the pair of observer B2.|||weighted Kappa coefficient||95% Confidence Interval|Number
2628127|NCT01881620|Primary|Inter-observer (B1 and B2) Reproducibility of the PET-CT by Anatomical Regions|The primary endpoint was the inter-observer reproducibility of the interpretation of the combined PET / enhanced CT scan (PET-CT) by anatomical region. Reproducibility was assessed for each of the 5 anatomical regions (thorax, abdomen, pelvis, bone, nervous system). Two independant pairs (B1 and B2), each composed of one nuclear physician and one radiologist interpreted the PET-CT examination and described each of the 5 anatomical régions according to 3 modalities (Presence of suspicious lesion(s); Presence of dubious lesion(s); Absence of suspicious and dubious lesion). The inter-observer reproducibility (inter-pairs of observers) was evaluated for each anatomical region by comparing the interpretations of the two pairs, using the weighted kappa concordance coefficient [ref = Fleiss J, Levin B, Cho Paik M. Statistical methods for rates and proportions. Third ed. 2003.].Interpretation by B1 after PET-CT examination (1 month after). Interpretation by B2 at the end of the study|1 year|Eligible patients with PET-CT scanner performed AND interpretation of 2 pairs of observors available.|||Weighted kappa concordance coefficient||95% Confidence Interval|Number
2628128|NCT01881230|Secondary|Percentage of Participants Who Discontinued From All Study Treatment Due to TEAEs|Treatment-emergent adverse events (TEAEs) were defined as any AEs that begin or worsen with an onset date on or after the date of the first dose of IP through 28 days after the last dose.|From randomization through to 28 days after the last dose of IP; up to data-cut off of date of 16 Dec 2016; maximum treatment duration of study drug exposure was 108.3 weeks for Arm A, 83 weeks for Arm B, 110.1 weeks for Arm C|The Safety/Treated population includes all randomized participants who received at least 1 dose of IP.|||percentage of participants||95% Confidence Interval|Number
2628129|NCT01881230|Secondary|Percentage of Participants Experiencing Dose Modifications (Reductions and Interruptions)|The number of participants with dose modifications occurring during the treatment period. Dose reductions and interruptions are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.|From randomization through to 28 days after the last dose of IP; up to data-cut off of date of 16 Dec 2016; maximum treatment duration of study drug exposure was 108.3 weeks for Arm A, 83 weeks for Arm B, 110.1 weeks for Arm C|The Safety/Treated population includes all randomized participants who received at least 1 dose of IP.|||percentage of participants|||Number
2628130|NCT01881230|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Treatment-emergent adverse events (TEAEs) were defined as any AEs that began or worsened with the onset date on or after the date of the first dose of IP through 28 days after the last dose. A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was graded based on the participant's symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity as follows: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death.|From randomization through to 28 days after the last dose of IP; up to data cut off date of 16 Dec 2016; maximum treatment duration of study drug exposure was 108.3 weeks for Arm A, 83 weeks for Arm B, 110.1 weeks for Arm C|The safety population includes all randomized participants who received at least 1 dose of IP.|||participants|||Number
2628131|NCT01881230|Secondary|Kaplan-Meier Estimates of Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death (from any cause).|From date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C|The ITT population includes all randomized participants regardless of whether the participant received any Investigational Product (IP) or had any efficacy assessments collected.|||months||95% Confidence Interval|Median
2628132|NCT01881230|Secondary|Percentage of Participants Who Initiated Cycle 6 Receiving Doublet Combination Therapy|The percentage of participants who initiated Cycle 6 receiving doublet combination therapy regardless of the need for dose modifications.|Cycle 6|ITT includes all randomized participants regardless of whether they received any IP or had any efficacy assessments collected. Those who did not have disease progression or had not died as of the data cutoff date were censored at the time of the last radiologic assessment prior to the data cutoff date.|||percentage of participants||95% Confidence Interval|Number
2628133|NCT01881230|Secondary|Percentage of Participants With an Objective Complete or Partial Overall Response by Investigator Assessment.|Percentage of participants with an Objective Complete or Partial Overall Response according to RECIST 1.1 and defined as: Complete response-disappearance of all target lesions; partial response at least a 30% decrease in the sum of diameters of target lesions from baseline; stable disease-neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for Progressive disease (PD)• Progressive Disease- At least a 20% increase in the sum of diameters of target lesions from nadir.|Disease response was assessed every 6 weeks; from date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C|ITT includes all randomized participants regardless of whether they received any IP or had any efficacy assessments collected. Those who did not have disease progression or had not died as of the data cutoff date were censored at the time of the last radiologic assessment prior to the data cutoff date.|||percentage of participants||95% Confidence Interval|Number
2628134|NCT01881230|Primary|Kaplan-Meier Estimates of Progression-Free Survival (PFS) Based on Investigator Assessment.|PFS was defined as the time from the date of randomization to the date of disease progression or death from any cause on or prior to the data cutoff date for the statistical analysis, whichever occurred earlier. Tumor responses were assessed every 6 weeks using, Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and defined as: Complete response (CR) is the disappearance of all target lesions; Partial response (PR) occurs when at least a 30% decrease in the sum of diameters of target lesions from baseline; Stable disease is neither sufficient shrinkage to qualify for a PR nor sufficient increase of lesions to qualify for Progressive disease (PD); Progressive Disease- is at least a 20% increase in the sum of diameters of target lesions from nadir.|From date of randomization to data cut-off date of 16 December 2016; total length of time on study was 31 months for Arm A, 34 months for Arm B and 35 months for Arm C|ITT includes all randomized participants regardless of whether they received any IP or had any efficacy assessments collected. Those who did not have disease progression or had not died as of the data cutoff date were censored at the time of the last radiologic assessment prior to the data cutoff date.|||months||95% Confidence Interval|Median
2628135|NCT01881126|Primary|Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM|IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) is measured at 8 AM, 12 PM, and 4 PM. IOP is either the average of 2 measurements, or, if a third measurement is required, the average of 3 measurements.|Week 12 at 8 AM, 12 PM, and 4 PM|Intent-to-Treat: all subjects who were randomized to study medication|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2628136|NCT01881113|Secondary|Tolerability of Study Medication at Visit 3A|Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|upon instillation, 1 minute and 2 minutes post instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2628137|NCT01881113|Secondary|Percentage of Participants With At Least One Nasal Symptom at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||% of participants|||Number
2628138|NCT01881113|Secondary|Percentage of Participants With At Least One Nasal Symptom at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||% of participants|||Number
2628139|NCT01881113|Secondary|Nasal Congestion at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2628140|NCT01881113|Secondary|Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2628141|NCT01881113|Secondary|Ear or Palate Pruritus at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2628142|NCT01881113|Secondary|Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2628143|NCT01881113|Secondary|Nasal Pruritus at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2628144|NCT01881113|Secondary|Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2628145|NCT01881113|Secondary|Rhinorrhea at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2628146|NCT01881113|Secondary|Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2628147|NCT01881113|Secondary|Tearing at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2628148|NCT01881113|Secondary|Tearing at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2628149|NCT01881113|Secondary|Eyelid Swelling at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2628150|NCT01881113|Secondary|Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2628151|NCT01881113|Secondary|Chemosis at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2628152|NCT01881113|Secondary|Chemosis at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2628153|NCT01881113|Secondary|Episcleral Redness at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2633476|NCT01824446|Primary|Volume of Distribution (Vz/F) of Radiolabelled SSP-004184|The distribution of a medication between plasma and the rest of the body.|Up to 288 hours post-dose|PAS|||Liters||Standard Deviation|Mean
2628154|NCT01881113|Secondary|Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2628155|NCT01881113|Secondary|Ciliary Redness at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2628156|NCT01881113|Secondary|Ciliary Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2628157|NCT01881113|Primary|Conjunctival Redness at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2628158|NCT01881113|Primary|Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2628159|NCT01881113|Primary|Ocular Itching at Onset of Action (15 Minutes Post-Dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2628160|NCT01881113|Primary|Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-Dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2628161|NCT01881087|Secondary|Failed Spinal Block Rate|Failed Spinal Block Rate for each treatment group|15 minutes after dose||||Participants|||Count of Participants
2628162|NCT01881087|Primary|Probability of Motor Block|Likelihood Rate of motor block persistence after a dosis of spinal HLBP 0.75%|200 minutes||||percentage of motor block|||Number
2628163|NCT01881009|Primary|Target Sensor Glucose 70-150 mg/dl|Percent of time in the target range of 70-150 mg/dl according to sensor glucose readings.|Approximately 12 hours|Intention to treat analysis of the inpatient overnight group. 3 participants that did not complete the inpatient overnight are excluded from the analysis.|||percentage of time|Nights analyzed (all participants)|Inter-Quartile Range|Median
2628164|NCT01881009|Secondary|Target Sensor Glucose 70-180 mg/dl|Compared to control nights, the percent of time in the target range of 70-180 mg/dl according to sensor glucose readings.|Approximately 12 hours|Target sensor glucose 70-180 mb/dl was a secondary outcome for the summer camp group only. 1 participant who withdrew from the summer camp session was excluded from the analysis.|||percentage of time|Nights analyzed (all participants)|Standard Deviation|Mean
2628165|NCT01881009|Primary|Target Sensor Glucose 70-150 mg/dl|Compared to control nights, the percent of time in the target range of 70-150 mg/dl according to sensor glucose readings.|Approximately 12 hours|Intention to treat analysis of the summer camp session. 1 participant who withdrew from the summer camp session was excluded from the analysis.|||percentage of time|Nights analyzed (all participants)|Standard Deviation|Mean
2628166|NCT01880840|Primary|Safety|"The objective of this clinical trial is to evaluate the safety of Astepro 0.15% Nasal Spray and Astepro 0.1% Nasal Spray at a dosage of 1 spray per nostril twice daily in subjects ≥6months to <6 years of age with allergic rhinitis.~Safety will be assessed on the basis of reported adverse experiences, nasal examinations, laboratory evaluations, and vital signs assessments.~Data for each age strata will be summarized separately as well as combined."|one month of treatment||||adverse events|||Number
2628167|NCT01880736|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes in the Maintenance Period|The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes in the maintenance period from 16 weeks to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|From week 16 to end of trial (week 27)|The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.|||episodes|||Number
2628168|NCT01880736|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes|The number of treatment emergent nocturnal (00:01-05:59 am) confirmed hypoglycaemic episodes over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.|||episodes|||Number
2633477|NCT01824446|Primary|Total Body Clearance (CL/F) of Radio-Labelled SSP-004184|The rate at which a drug is removed from the body.|Up to 288 hours post-dose|PAS|||L/hr||Standard Deviation|Mean
2628169|NCT01880736|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period|The number of treatment mergent confirmed hypoglycaemic episodes in the maintenance period from Week 16 to end of trial (week 27) was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs. stepwise). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L.|From Week 16 to end of trial (week 27)|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product. Subjects were grouped either according to dosing pattern or treatment algorithm received. 451 subjects contributed to the analysis. Subjects in the safety analysis set contributed to the evaluation “as treated”.|||episodes|||Number
2628170|NCT01880736|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) Definition|Number of treatment emergent hypoglycaemic episodes according to the ADA definition (classified as severe hypoglycaemia, documented hypoglycaemia, asymptomatic hypoglycaemia, probable symptomatic hypoglycaemia, relative hypoglycaemia) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.|||episodes|||Number
2628171|NCT01880736|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Defined as Severe Hypoglycaemia and/or a Measured Plasma Glucose (PG) Less Than 3.1 mmol/L (Less Than 56 mg/dL))|The confirmed hypoglycaemic episodes (defined as severe hypoglycaemia and/or a measured plasma glucose (PG) less than 3.1 mmol/L [less than 56 mg/dL]) over the time period of Week 0-26 was recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise).|Weeks 0-26|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.|||episodes|||Number
2628172|NCT01880736|Secondary|Incidence of Treatment Emergent Adverse Events (TEAEs)|The incidences of treatment emergent adverse events (TEAEs) over the time period of Week 0-26 were recorded by dosing regimen (flexible vs. fixed dosing); and by titration algorithm (simple vs stepwise).|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. 458 subjects were grouped according to dosing pattern or treatment algorithm received. Subjects in the safety set contributed to the evaluation “as treated”.|||events|||Number
2628173|NCT01880736|Secondary|Responder for HbA1c (%) Based on Central Laboratory Assessment: HbA1c Below 7.0% at End of Trial|The number of subjects who achieved the pre-defined HbA1c target (<7.0%) after 26 weeks of treatment was recorded by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).|After 26 weeks of treatment|The FAS included all randomised subjects. 458 subjects were grouped according to dosing pattern or treatment algorithm received. Analysis was per intention to treat principle. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.|||Subjects|||Number
2628174|NCT01880736|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Changes from baseline in FPG values over the time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise).|Week 0, week 26|The FAS included all randomised subjects. 458 subjects were grouped according to dosing pattern or treatment algorithm received. Analysis was per intention to treat principle. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.|||mg/dL||Standard Deviation|Mean
2628175|NCT01880736|Primary|Change From Baseline in HbA1c (%) Glycosylated Haemoglobin)|Changes from baseline in HbA1c values over time period of Week 0-26 were evaluated by dosing regimen (flexible vs. fixed dosing) and by titration algorithm (simple vs stepwise)|Week 0, week 26|The full analysis set (FAS) included all randomised subjects. 458 subjects were grouped either according to dosing pattern or treatment algorithm received. Analysis was per intention to treat principle. Missing values were imputed using the Last Observation Carried Forward (LOCF) method.|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
2628176|NCT01880723|Secondary|Peripheral Oxygen Saturation|A finger pulse oximeter allowed for the measurement of peripheral oxygen saturation at baseline, 30-, 60- and 90-minutes post albuterol in cystic fibrosis and healthy subjects.|baseline, 30-, 60- and 90-minutes post albuterol||||percent of oxygenated hemoglobin||Standard Deviation|Mean
2628177|NCT01880723|Primary|Net Exhaled Chloride|"The calculation of net chloride efflux was used to account for the paracellular reabsorption of Cl- that will follow the reabsorption of Na+ to maintain electroneutral ion flux. Thus, the net chloride efflux calculation used was the gross chloride concentration plus the absolute value of the percent change in sodium from baseline multiplied by the gross chloride concentration for each time point:~Net Cl- efflux - [Cl- X-min post] + (([Na+ X-min post]-[Na+Baseline])/ [Na+Baseline]) x [Cl- X-min post])"|baseline to 90 minutes post albuterol administration||||mmol/L||Standard Deviation|Mean
2628178|NCT01880723|Secondary|Diffusion Capacity of the Lungs for Nitric Oxide|Using the rebreathe technique the diffusion capacity of the lungs for carbon monoxide and nitric oxide were measured, and this allowed for the determination of alveolar-capillary membrane conductance and pulmonary capillary blood volume. These measurements were made at baseline and 30-, 60- and 90-minutes post albuterol administration in cystic fibrosis and healthy subjects.|baseline, 30-, 60- and 90-minutes post albuterol administration||||mL/min/mmHg||Standard Deviation|Mean
2628179|NCT01880723|Secondary|Diffusion Capacity of the Lungs for Carbon Monoxide|Using the rebreathe technique the diffusion capacity of the lungs for carbon monoxide and nitric oxide were measured, and this allowed for the determination of alveolar-capillary membrane conductance and pulmonary capillary blood volume. These measurements were made at baseline and 30-, 60- and 90-minutes post albuterol administration in cystic fibrosis and healthy subjects.|baseline, 30-, 60- and 90-minutes post albuterol administration||||mL/min/mmHg||Standard Deviation|Mean
2628180|NCT01880723|Primary|Exhaled Sodium (mmol/L)|We collected exhaled breath condensate (EBC) samples, with subjects breathing on a Jaeger EcoScreen for 20 minutes. EBC samples were collected in cystic fibrosis and healthy subjects before and 30-, 60-, and 90-minutes following albuterol administration.|up to 90-minutes post albuterol||||mmol/L||Standard Deviation|Mean
2628181|NCT01880697|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVc|The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (throughout the study period), after receiving one dose of TIVc is reported.|Day 1 through Day 22 post-vaccination|Analysis was done on the unsolicited safety set population i.e all subjects who have post-vaccination AE or reactogenicity records.|||Subjects|||Number
2628182|NCT01880697|Primary|Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIVc|The number of adult and elderly subjects reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of TIVc are reported.|Day 1 to Day 4 post-vaccination|Analysis was done on the solicited safety set population i.e all subjects who have post-vaccination AE or reactogenicity records.|||Subjects|||Number
2628183|NCT01880697|Primary|Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc|"The antibody responses following one dose of TIVc were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIVc.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22/day 1|Analysis was done on the per-protocol population.|||Ratio||95% Confidence Interval|Geometric Mean
2628184|NCT01880697|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIVc|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIVc.~Seroconversion is defined as percentage of subjects with a pre-vaccination HI titer <10 to a post-vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre-vaccination HI titer >10 to at least a 4-fold increase in post-vaccination HI antibody titers.~The related European (CHMP) criterion for the assessment of immunogenicity is met if >40 % for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination HI titers."|Day 22 (vaccination is on day 1)|Analysis was done on the per-protocol population.|||Percentages of Subjects||95% Confidence Interval|Number
2628185|NCT01880697|Primary|Percentage of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIVc.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 22 (vaccination is on day 1)|Analysis was done on the per-protocol population.|||Percentages of Subjects||95% Confidence Interval|Number
2628186|NCT01880697|Primary|Geometric Mean Ratio of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIVc|The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIVc The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 in for subjects aged ≥61 years.|Day 22/day 1|Analysis was done on the per-protocol population.|||Ratio||95% Confidence Interval|Geometric Mean
2628187|NCT01880697|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains ,three weeks after receiving one dose of TIVc.~Seroconversion is defined as percentage of subjects with a pre-vaccination SRH area ≤4mm2 achieving a post-vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area >4mm2 achieving at least 50% increase in post-vaccination SRH area.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years."|Day 22 (vaccination is on day 1)|Analysis was done on the per-protocol population.|||Percentages of Subjects||95% Confidence Interval|Number
2628188|NCT01880697|Primary|Percentage of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIVc|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIVc.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 22 (vaccination is on day 1)|Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have RT-PCR confirmed influenza during the study.|||Percentages of Subjects||95% Confidence Interval|Number
2628189|NCT01880593|Secondary|Patient Rated Inventory of Side Effects (PRISE)|Number of Participants with PRISE|2 weeks after last ketamine infusion||||Participants|||Count of Participants
2628190|NCT01880593|Secondary|CSSRS Score|Columbia Suicide Severity Rating Scale (CSSRS) - Full range from 0 (low intensity suicidal ideation to 9 (high intensity suicidal ideation).|2 weeks after last ketamine infusion||||units on a scale||Standard Deviation|Mean
2628191|NCT01880593|Secondary|BSS Score|BECK Scale for Suicidal Ideation (BSS) - 0-13 Minimal; 14-19 Mild; 20-28 Moderate; 29-63 Severe|2 weeks after last ketamine infusion||||units on a scale||Standard Deviation|Mean
2628192|NCT01880593|Secondary|HAM-A Score|Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.|2 weeks after last ketamine infusion||||units on a scale||Standard Deviation|Mean
2628269|NCT01879579|Other Pre-specified|Costs - Titration Visit Information|The number of insulin titration visits (whether by phone or in the clinic).|12 weeks|Participants who completed the allocated intervention (and the participant who discontinued insulin early).|||insulin titration visits||Inter-Quartile Range|Median
2628193|NCT01880593|Secondary|CGI-S Score|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|2 weeks after last ketamine infusion||||units on a scale||Standard Deviation|Mean
2628194|NCT01880593|Secondary|QIDS-SR Score|Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) score - Each item is rated 0 (no depression) to 3 (severe depression), for a total score range of 0 (no depression) to 27 (severe depression).|2 weeks after last ketamine infusion||||units on a scale||Standard Deviation|Mean
2628195|NCT01880593|Primary|MADRS-S Score|The Montgomery Asberg Depression Rating Scale (MADRS-S) has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).|2 weeks after last ketamine infusion||||units on a scale||Standard Deviation|Mean
2628196|NCT01880528|Secondary|Total LCSS Score as Measure by the Lung Cancer Symptom Scale (LCSS) at Week 4|Total LCSS score as measured using the Lung Cancer Symptom Scale (LCSS) at Week 4. The item scale ranges from 0-10 (0 = None; 10 = As much as it could be) where the LCSS scoring algorithm is applied to convert to a 0-100 point scale where 100 is best quality of life (QOL), for comparability.|At Week 4|Patients who completed the LCSS at week 4 are included in this analysis.|||score on a scale||Standard Deviation|Mean
2628197|NCT01880528|Secondary|Quality of Life (Dyspnea When Climbing Stairs) Assessed Using Item #5 of the European Organization for Research on the Treatment of Cancer Lung Cancer Module Survey (EORTC-QLQ-LC13) at Week 4|"Dyspnea when climbing as measured using item #5 (Were you short of breath when you climbed stairs?) of the EORTC-QLQ-LC13 at Week 4. The item scale ranges from 1-4 (1 = Not at all; 4 = Very Much) where the EORTC-QLQ-LC13 scoring algorithm is applied to convert to a 0-100 point scale where 100 is best quality of life (QOL), for comparability."|At Week 4|Patients who completed item #5 on the EORTC-QLQ-LC13 at week 4 are included in this analysis.|||score on a scale||Standard Deviation|Mean
2628198|NCT01880528|Secondary|Experience Shortness of Breath During Exercise as Measured Using Item #3 on the Symptom Experience Questionnaire (SEQ) at Week 4|"Experience shortness of breath during exercise as measured using Item #3 (Over the past week, did you experience shortness of breath when you exercise or exert yourself?) on the Symptom Experience Questionnaire (SEQ) at Baseline. The item scale ranges from 0-10 (0 = Not at all; 10 = As bad as it can be) where the SEQ scoring algorithm is applied to convert to a 0-100 point scale where 100 is best quality of life (QOL), for comparability."|At Week 4|Patients who completed Item #3 on the SEQ at week 4 are included in this analysis.|||score on a scale||Standard Deviation|Mean
2628199|NCT01880528|Secondary|Acute Respiratory Distress (Dyspnea), Measured Using of the Maximum Score, at Any Time, of the Shortness of Breath Question (Item #4) on the LCSS (Worst Dyspnea Score)|"Acute respiratory distress (dyspnea), measured using of the maximum score, at any time, of the shortness of breath question (Item #4 How much shortness of breath do you have?) on the Lung Cancer Symptom Scale (LCSS) (Worst Dyspnea Score). The LCSS tool contains 6 major symptoms associated with lung malignancies and their effect on overall symptomatic distress, functional activities, and global quality of life (QOL). The item scale ranges from 0-10 (0 = None; 10 = As much as it could be) where the LCSS scoring algorithm is applied to convert to a 0-100 point scale where 100 is best quality of life (QOL), for comparability. Patient scores range from 0 to 100, where 100 was best QOL (i.e. less pulmonary distress)."|Up to 3 months post-radiation therapy|Patients who completed the LCSS Item #4 at any time during the study are included in this analysis.|||score on a scale||Standard Deviation|Mean
2628200|NCT01880528|Primary|Incidence of Grade 3 or Higher Hypotension, Acute Kidney Injury, Allergic Reaction, or Anaphylaxis, as Measured Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0|Incidence of grade 3 or higher hypotension, acute kidney injury, allergic reaction, or anaphylaxis, as measured using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. Descriptive statistics of frequency (percentage) will be used to summarize adverse event (AE) incidence and severity in the lisinopril and placebo arms separately.|Up to 3 months post-radiation therapy||||percentage of patients|||Number
2628201|NCT01880515|Secondary|Progression Free Survival|From the start of consumption of BIBW 2992 to the date progression or last follow up|Participants will be followed for the duration of the treatment, an average of 8 weeks.|We estimated the progression free survival with the Kaplan Meier method, and comparisons among groups were performed with the log-rank test.|||months||95% Confidence Interval|Median
2628202|NCT01880515|Secondary|Progression Free-survival|The measure will be from the start of consumption to the first documented evidence of progression according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, or if patients still survive the measure will be made after 24 weeks|24 weeks from baseline||2017-09-30|09/2017||||
2628203|NCT01880515|Secondary|Quality of Life (QL)|A QL questionnaire from European Organization for Research and Treatment of Cancer (EORTC) organization (spanish version) will be performed at initiation of BIBW 2992 and then every month of follow-up until progression|from baseline to 6 months|||||||
2628204|NCT01880515|Primary|Frequency of Participants Who Experienced Any Grade of Rash As Characterized By The Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0|Sum of participants who experienced any grade rash according to the Common Toxicity Criteria for Adverse Effects (CTCAE) V4.0, from the initiation of BIBW2992 compared to week 8.|Percentage of adverse events at week 8|Forty five patients were assigned to receive reactive treatment; the other 45 received pre-emptive tetracycline.There were no differences among demographics, disease stage and dermatological baseline characteristics between treatment groups.|||Percentage of Patients w/any grade rash|||Number
2628205|NCT01880437|Secondary|Area Under the Concentration-time Curve (AUC) of Cytarabine|PK data was planned to be reported only if the results of Cohort 2 are available.|Predose, 0.25, 0.5, 1, 3, 6 hours post-dose on Days 1, 8 and 29|No participants were enrolled as the study was terminated prior to the initiation of Cohort 2.||||||
2628206|NCT01880437|Secondary|Pharmacokinetics (PK): Steady-state Plasma Concentration of Vismodegib|PK data was planned to be reported only if the results of Cohort 2 are available.|Predose on Days 8, 29 and 57|As the study was terminated prior to Cohort 2 enrollment, PK analysis could not be performed, as planned.||||||
2628209|NCT01880437|Secondary|Duration of Overall Response (DOR)|DOR is defined as the time from the first occurrence of a documented overall response to the time of relapse, as determined by the investigator using International Working Group (IWG) criteria (Participants not falling under any of the response criteria [CR or CRi or MLFS or PR] described under outcome measure 1 were considered as non-responders) or death from any cause during the study (defined as death within 30 days after the last dose of study drug).|Up to 30 days of last dose of study drug (maximum treatment duration = 225 days)|Efficacy population including participants who were considered as responders.|||weeks||95% Confidence Interval|Median
2628210|NCT01880437|Secondary|Percentage of Participants With CR, CRi, MLFS or PR at Anytime During Study Treatment|CR was defined as achieved if the neutrophils count >1000 cells/µL, platelets count >100000/µL, bone marrow blasts <5%, no Auer rods (clumps of azurophilic granular material that form elongated needles seen in the cytoplasm of leukemic blasts), no transfusion requirements and no signs of EMD. CRi was defined if either of the cell (neutrophil or platelet) lineage was not recovered (neutrophils > 1000 cells/µL or NA or platelets count >100000/µL or NA, bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. MLFS (neutrophil and platelet criteria were NA) was defined as bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. PR was defined as neutrophils count >1000 cells/µL, platelets count >100000/µL, and >50% decrease from baseline to a range of 5-25% of bone marrow blasts or blasts <5% with Auer rods. The 95% confidence intervals (CI) were constructed using Blyth-Still-Cassella method.|Up to 30 days of last dose of study drug (maximum treatment duration = 225 days)|Efficacy analysis population included all enrolled participants. Here “number of participants analyzed” included participants who were evaluable for tumor response at anytime during the study.|||percentage of participants||95% Confidence Interval|Number
2628211|NCT01880437|Primary|Percentage of Participants With a Complete Response (CR) or CR With Incomplete Blood Count Recovery (CRi) or Morphologic Leukemia Free State (MLFS) or Partial Response (PR) at Week 8|CR was defined as achieved if the neutrophils count was greater than (>) 1000 cells per microliter (µL), platelets count >100000/µL, bone marrow blasts percentage (%) less than (<) 5, no Auer rods (clumps of azurophilic granular material that form elongated needles seen in the cytoplasm of leukemic blasts), no transfusion requirements and no signs of extra medullary disease (EMD). CRi was defined if either of the cell (neutrophil or platelet) lineage was not recovered (neutrophils >1000 cells/µL or Not applicable [NA] or platelets count >100000/µL or NA), bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. MLFS (neutrophil and platelet criteria were NA) was defined as bone marrow blasts <5% with no Auer rods and confirmed by flow cytometry with no signs of EMD. PR was defined as neutrophils count >1000 cells/µL, platelets count >100000/µL, and >50% decrease from baseline to a range of 5-25% of bone marrow blasts or blasts <5% with Auer rods.|Week 8|As the primary efficacy time-point (Week 8) was not reached for all participants due to study termination based on interim data analysis, the analysis of this outcome measure could not be performed, as per planned analysis.||||||
2628212|NCT01880424|Secondary|Change From Baseline in 12-week Abdominal Discomfort|"The change from baseline in 12-week abdominal discomfort (i.e., the average of the non-missing daily abdominal discomfort scores reported during the 12-week Treatment Period).~Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).|||Units on a Scale||Standard Error|Least Squares Mean
2628213|NCT01880424|Secondary|Change From Baseline in 12-week Abdominal Pain|"The change from baseline in 12-week abdominal pain (i.e., the average of the non-missing daily abdominal pain scores reported during the 12-week Treatment Period).~Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal pain and 10 represents very severe abdominal pain."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).|||Units on a Scale||Standard Error|Least Squares Mean
2628214|NCT01880424|Secondary|Change From Baseline in 12-week Abdominal Bloating|"The change from baseline in 12-week abdominal bloating (i.e., the average of the non-missing daily abdominal bloating scores reported during the 12-week Treatment Period).~Abdominal bloating (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal bloating and 10 represents very severe abdominal bloating."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).|||Units on a Scale||Standard Error|Least Squares Mean
2628215|NCT01880424|Secondary|Change From Baseline in 12-week Severity of Straining|"The change from baseline in 12-week severity of straining (i.e., the average of the non-missing straining scores from the SBMs occurring during the 12-week Treatment Period).~Severity of straining was assessed daily by patients on a 5-point ordinal scale (1=Not at all to 5=An extreme amount)."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).|||Units on a Scale||Standard Error|Least Squares Mean
2628216|NCT01880424|Secondary|Change From Baseline in 12-week Stool Consistency|"The change from baseline in 12-week stool consistency (i.e., the average of the non-missing Bristol Stool Form Scale [BSFS] score from the SBMs occurring during the 12-week Treatment Period).~Consistency of each bowel movement was assessed daily by patients using the 7-point BSFS (1=Separate hard lumps like nuts [difficult to pass] to 7=Watery, no solid pieces [entirely liquid])."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).|||Units on a Scale (BSFS)||Standard Error|Least Squares Mean
2646948|NCT01699789|Secondary|Any Missed Work Day in Last 30 Days, if Working||6 months follow-up||||percentage of participants||95% Confidence Interval|Number
2628217|NCT01880424|Secondary|Change From Baseline in 12-week Spontaneous Bowel Movement Frequency Rate|"The change from baseline in 12-week SBM frequency (i.e., average weekly SBM frequency over the 12 weeks of the Treatment Period).~SBM is defined as a bowel movement without laxative use in the preceding 24 hours."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).|||SBMs per Week||Standard Error|Least Squares Mean
2628218|NCT01880424|Secondary|Change From Baseline in 12-week Complete Spontaneous Bowel Movement Frequency Rate|"The change from baseline in 12-week CSBM frequency (i.e., average weekly CSBM frequency over the 12 weeks of the Treatment Period).~A spontaneous bowel movement (SBM) is defined as a bowel movement without laxative use in the preceding 24 hours. A CSBM is defined as an SBM that is associated with a sense of complete evacuation."|Baseline and 12-week Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients); analysis includes patients with analysis values at both baseline and during the Treatment Period. An observed cases approach to missing post-baseline data was applied (i.e., no imputation for missing values).|||CSBMs per Week||Standard Error|Least Squares Mean
2628219|NCT01880424|Primary|12-week Irritable Bowel Syndrome (IBS) Degree of Relief Responder|"A 12-week IBS Degree of Relief Responder is a patient who meets the IBS Degree of Relief Weekly Responder criteria (i.e., response to the degree of relief of IBS symptoms question for that week was Considerably relieved or Completely relieved) for at least 6 out of the 12 weeks of the Treatment Period.~Degree of relief of IBS symptoms (in the last 7 days) was assessed weekly by patients on a 7-point balanced ordinal scale where 1 = Completely relieved, 4 = Unchanged, and 7 = As bad as I can imagine."|Baseline and Weeks 1-12 during the Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients). If a patient did not have an IBS degree of relief score for a particular Treatment Period week, the patient was not considered a responder for that week.|||Participants|||Number
2628220|NCT01880424|Primary|12-week Abdominal Pain/Abdominal Discomfort Weekly Responder|"A 12-week Abdominal Pain/Abdominal Discomfort Responder is a patient who meets the Abdominal Pain/Abdominal Discomfort Weekly Responder criteria (i.e., an improvement of ≥30% from baseline in either the mean abdominal pain score or mean abdominal discomfort score for that week, with neither score worsening from baseline for that week) for at least 6 out of the 12 weeks of the Treatment Period.~Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point numerical rating scale (NRS) where 0 represents no abdominal pain and 10 represents very severe abdominal pain.~Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort."|Baseline and Weeks 1-12 during the Treatment Period|Intent to Treat (ITT) Population (all 839 randomized patients). If a patient did not have an abdominal pain score or abdominal discomfort score for a particular Treatment Period week, the patient was not considered a responder for that week.|||Participants|||Number
2628221|NCT01880320|Primary|Changes From Baseline in Non-Inflammatory Lesion Counts||Baseline - Week 12|ITT Population, Multiple Imputation|||lesions||Standard Error|Least Squares Mean
2628222|NCT01880320|Primary|Changes From Baseline in Inflammatory Lesion Counts||Baseline - Week12|ITT Population, Multiple imputation|||Lesions||Standard Error|Least Squares Mean
2628223|NCT01880320|Primary|Success Rate|"Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA).~Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets."|Week 12|Intent-to-treat (ITT): All subjects who were randomized. Baseline IGA Severe population: All randomized subjects who had IGA=4 at baseline.|||percentage of participants|||Number
2628224|NCT01880099|Primary|Smoking Choice Procedure|After overnight abstinence, participants will receive 10 tokens at the beginning of the smoking choice session. These tokens can be exchanged for money (0.75$ / token) or 2 cigarette puffs. The session starts with sample smoking of 2 puffs that allows subjective responses to me measured after abstinence. 15 min later, participants make their first choice, followed by 9 additional choices, every 15 minutes.|Data was acquired during a single test session during week 3 of drug intervention.|The number of participants analyzed per arm for this outcome is different than participant flow data because not every participant completed the smoking choice session.|||# of choices to smoke (out of 10)||Standard Deviation|Mean
2628225|NCT01880086|Secondary|Men's Sexual Health Questionnaire (MSHQ) Questionnaire|Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Minimum score is 1, maximum score is 20. Minimum score is considered most symptomatic, maximum score is considered least symptomatic.|3 months post initial visit||||scores on a scale||Standard Deviation|Mean
2628226|NCT01880086|Secondary|Sexual Health Inventory for Men (SHIM) Questionnaire|Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Minimum score is 1, maximum score is 25. The minimum value is most symptomatic and maximum value is least symptomatic.|3 months post initial visit||||scores on a scale||Standard Deviation|Mean
2628227|NCT01880086|Secondary|Estradiol||3 months post initial visit||||pg/mL||Standard Deviation|Mean
2628228|NCT01880086|Secondary|Hematocrit (%)|Measure hematocrit from baseline.|3 months post initial visit||||percentage||Standard Deviation|Mean
2628229|NCT01880086|Secondary|Androgen Deficiency in the Aging Male (ADAM) Questionnaire|Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Minimum score is 0 and maximum score is 10. 0 is most symptomatic, and 10 is least symptomatic.|3 months post initial visit||||scores on a scale||Standard Deviation|Mean
2628230|NCT01880086|Secondary|Other Hormonal Profile (Change From Baseline)|Luteinizing hormone (LH)|3 months post initial visit||||IU/mL||Standard Deviation|Mean
2628231|NCT01880086|Primary|Serum Total Testosterone (Change From Baseline)|Morning venipuncture of serum total testosterone.|3 months post initial visit||||ng/mL||Standard Deviation|Mean
2628232|NCT01880047|Secondary|Number of Particiapants With Drug Related Adverse Events|Monitoring for AEs, SAEs, abnormalities in liver or kidney function, thrombotic complications, hematologic malignancies, parameters suggesting bone marrow fibrosis (a bone marrow may be done at the discretion of the investigator), cataracts.|8 weeks||||Participants|||Count of Participants
2646949|NCT01699789|Secondary|Working for Pay||6 months follow-up||||percentage of participants||95% Confidence Interval|Number
2628233|NCT01880047|Primary|Number of Patients Responding to >75mg Daily as Defined by a Rise in Platelet Count by 20,000/Microliter, With a Total Platelet Count >50,000/Microliter, ON TWO CONSECUTIVE OCCASIONS During the 8 Week Period|To determine if patients with chronic ITP who do not respond to 75 mg of eltrombopag daily given for at least 3 weeks but then do respond to eltrombopag given daily first for 2 weeks at doses of 100, then for 2 weeks at 125 mg and finally for 4 weeks at a dose of 150mg daily. Response will be defined as 2 consecutive platelet counts of > 50,000 with an increase of > 20,000 from the study baseline within the 8 week increased dose window not as a result of rescue treatment.|8 weeks||||Participants|||Count of Participants
2628234|NCT01879852|Secondary|Change in Urinary Concentrations of C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)|CTX-II is a biomarker of Type II collagen degradation. Early-morning, second void, fasting urine samples will be collected and stored. Concentrations of CTX-II will be determined with enzyme-linked immunosorbent assay, corrected for creatine concentration, and log-transformed. Creatinine concentration will also be determined with enzyme-linked immunosorbent assay.|Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)|2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing.|||log (ng/mmol)||Standard Deviation|Mean
2628235|NCT01879852|Secondary|Single Leg Forward Hop Index|Three trials of the single leg forward hop will be collected on each side. Distance will be averaged across trials. The single leg hop index will be computed as [(distance on the surgical side/distance on the non-surgical side) *100]|7 weeks post-surgery (post-intervention)|2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing. 2 subjects in the Standard Rehabilitation group and 1 subject in the Standard + Quadriceps Intensive Strengthening group did not complete hop testing.|||percentage||Standard Deviation|Mean
2628236|NCT01879852|Primary|Change in Tibial Articular Cartilage Volume|A magnetic resonance image (MRI) of the knee will be acquired and software will be used to quantify tibial articular cartilage volume.|Baseline (pre-surgery) to 1 year post-surgery|2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing. Images were not analyzable for one subject in the Standard+Quadriceps Intensive Strengthening group.|||percentage change from baseline||Standard Deviation|Mean
2628237|NCT01879852|Primary|Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score|The IKDC is a measure of self-reported knee function and includes items related to symptoms and functional activity. Responses on the IKDC subjective knee form will be recorded on hard-copy and the summary score computed. The highest (best) possible score is 100 points and the lowest (worst) possible score is 0 points.|Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)|2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing.|||units on a scale||Standard Deviation|Mean
2628238|NCT01879826|Secondary|Parent Perception of Patient Pain Report|Parent Perception of Patient Pain, scale is from 0 to 10, minimum value is 0, maximum value is 10, higher scores mean better outcome.|1 day||||units on a scale||Standard Error|Mean
2628239|NCT01879826|Primary|Patient Pain/Anxiety|The patient will complete a visual analog scale (rate 0-10) to assess pain after the procedure. Zero is no pain and 10 is worse pain. Change was calculated by baseline minus day one.|1 day|Number of participants in the final analysis were included.|||units on a scale||Standard Error|Mean
2628240|NCT01879800|Secondary|Mean Change in Hamilton Anxiety Rating Scale (HAM-A) From Baseline to 3 and 6 Month Follow-up|"The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety.~Each item is scored independently based on a five-point, ratio scale. Upon the completion of the evaluation, the clinician compiles a total, composite score based upon the summation of each of the 14 individually rated items. This calculation will yield a comprehensive score in the range of 0 to 56. It has been predetermined that the results of the evaluation can be interpreted as follows. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. A score of 25 to 30 indicates a moderate to severe anxiety severity. Lastly, a score above 30 represents severe anxiety severity. The mean change in ratings will be assessed from baseline to 3 and 6 months follow up."|3- and 6- Month Follow-Up||||units on a scale||Standard Error|Mean
2628241|NCT01879800|Secondary|Mean Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 3 and 6 Month Follow-up|"The HAM-D is a structured clinical interview for assessing depression severity. Outcome measure will be change from Baseline in Hamilton Depression Rating Scale and at 3 and 6 month follow-ups.~Measure is scored by adding individual items and attaining an overall severity score. Scores range from 0 to 53, with higher values signifying a higher level of depression severity (and thus a worse outcome). A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial."|3-month and 6-Month Follow-Up||||units on a scale||Standard Deviation|Mean
2628242|NCT01879800|Primary|Mean Change in Participants World Health Organization Quality of Life Measure- Physical Score: Change From Baseline to 3 and 6 Month Follow-up.|"The World Health Organization Quality of Life Measure- Physical scale assesses quality of life in physical health- specifically in activities of daily living, Dependence on medicinal substances and medical aids, Energy and fatigue, Mobility, Pain and discomfort, Sleep and rest, and Work Capacity. Outcome measure will be the change from baseline, at 3, and 6 months.~Each item ranges in score from 1-5. Individual items are rated on a 5 point Likert scale where 1 indicates low, negative perceptions and 5 indicates high, positive perceptions. As such, domain and facet scores are scaled in a positive direction where higher scores denote higher quality of life.~The mean score of the items within this physical domain is used to calculate the overall physical domain score. Mean scores are then multiplied by 4, yielding a score of 4 to 20. A higher domain score indicates a higher quality of life in physical ability."|Change at 3 and 6- Month Follow-up||||units on a scale||Standard Error|Mean
2628243|NCT01879735|Primary|Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar||All measurements are performed in one day.||||percentage of participants|||Number
2628244|NCT01879722|Secondary|CLr: Renal Clearance of TAK-063 and TAK-063 Metabolite M-I|CLr is a measure of apparent clearance of the drug from the urine calculated as total amount excreted in the urine from time 0 to 24 hours postdose / plasma area under the curve from time 0 to 24 hours post-dose.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||mL/hour||Standard Deviation|Mean
2628245|NCT01879722|Secondary|Fe: Fraction of Drug Excreted in Urine for TAK-063|Fe is a measure of the fraction of drug excreted in urine and is calculated as Fe = (total amount excreted in the urine from time 0 to 24 hours post-dose / dose)×100|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||percent||Standard Deviation|Mean
2628246|NCT01879722|Secondary|Ae(0-24): Total Amount Excreted in the Urine From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I|Ae(0-24) is a measure of the total amount of study drug excreted in the urine from time 0 to 24 hours postdose.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||ng||Standard Deviation|Mean
2628247|NCT01879722|Secondary|Accumulation Ratios Between Day 7 AUC(0-24) and Day 1 AUC(0-24)|Accumulation ratios between Day 7 AUC(0-24) and Day 1 AUC(0-24), (Day 7/Day 1). Estimated Ratio (Day 7/Day 1) is the exponentiated results of the difference between Day 7 and Day 1 in log-transformed values which resolves to the ratio of Day 7/Day 1 estimates.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||ratio||90% Confidence Interval|Mean
2628248|NCT01879722|Secondary|AUC(0-24) Ratio: Ratio of TAK-063 Metabolite AUC(0-24) to TAK-063 AUC(0-24)|AUC(0-24) Ratio is the ratio of AUC(0-24) values of the metabolite compared to the parent calculated by dividing AUC(0-24) values of metabolite M-I with those of the parent drug TAK-063.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||ratio||Standard Deviation|Mean
2628249|NCT01879722|Secondary|Cmax Molar Ratio: Ratio of TAK-063 Metabolite Cmax to TAK-063 Cmax|Cmax Molar Ratio is the ratio of Cmax molar values of the metabolite compared to the parent calculated by dividing Cmax molar values of metabolite M-I with those of TAK-063.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||ratio||Standard Deviation|Mean
2628250|NCT01879722|Secondary|Average Plasma Concentration on Day 1 (Cav) and Day 7 (Cavss) for TAK-063 and TAK-063 Metabolite M-I|Cav is the Average plasma concentration on Day 1, calculated as AUC(0-24)/24 on Day 1. Cavss is the average plasma concentration on Day 7, calculated as AUC(0-24)/24 on Day 7.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants for whom PK data was available for analysis.|||ng/mL||Standard Deviation|Mean
2628251|NCT01879722|Secondary|CL/F: Oral Clearance of TAK-063|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by area under the curve from time 0 to 24 hours post-dose, after multiple dosing (at steady state).|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||liter/hour||Standard Deviation|Mean
2628252|NCT01879722|Secondary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-063 and TAK-063 Metabolite M-I|AUC(0-24) is a measure of total plasma exposure to the drug from Time 0 to 24 hours post-dose.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||ng*hr/mL||Standard Deviation|Mean
2628253|NCT01879722|Secondary|AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-063 and TAK-063 Metabolite M-I|AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the Last Quantifiable Concentration.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||ng*hr/mL||Standard Deviation|Mean
2628254|NCT01879722|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-063 and TAK-063 Metabolite M-I|Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||hour||Full Range|Median
2628255|NCT01879722|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-063 and TAK-063 Metabolite M-I|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Days 1 and 7 pre-dose and multiple time-points post-dose (Up to 24 hours)|PK Set included all randomized participants who received study drug for whom PK data was available for analysis.|||ng/mL||Standard Deviation|Mean
2628256|NCT01879722|Primary|Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters|The percentage of participants who meet markedly abnormal criteria specified by the protocol and statistical analysis plan during the treatment period.|Day 1 to Day 8|Safety population included all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
2628257|NCT01879722|Primary|Percentage of Participants With Markedly Abnormal Vital Sign Measurements|The percentage of participants who meet markedly abnormal criteria for vital signs, including oral body temperature, respiration rate, pulse, and resting blood pressure and after standing|Day 1 to Day 8|Safety population included all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
2628258|NCT01879722|Primary|Percentage of Participants With Markedly Abnormal Safety Laboratory Tests|The percentage of participants with any markedly abnormal standard safety laboratory values, including hematology, serum chemistries, and urinalysis, during the treatment period.|Day 1 to Day 8|Safety population included all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
2628270|NCT01879579|Other Pre-specified|Costs - Provider Time Spent on Insulin Titration Visits|Provider time spent on insulin titration visits by phone compared to insulin titration visits in the clinic.|12 weeks|Insulin titration visits with a duration recorded.|||minutes|Participants|Inter-Quartile Range|Median
2628271|NCT01879579|Other Pre-specified|Patient Healthcare Utilization|The number of medication refill, emergency department, and walk-in clinic visits at Bellevue Hospital (non-insulin titration visits).|12 weeks|All participants.|||hospital visits|||Number
2646950|NCT01699789|Secondary|My Life is Organized||6 months follow-up||||percentage of participants||95% Confidence Interval|Number
2628259|NCT01879722|Primary|Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) After 7 Days of Dosing|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Day 1 to Day 14|Safety population included all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
2628260|NCT01879683|Primary|Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28|The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR) = presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.|Baseline, Day 28|Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations.|||percentage of participants|||Number
2628261|NCT01879683|Secondary|Change From Baseline in Patient Reported IC Symptom: Daily Total Voids|The number of day-time voidings and the number of night-time voidings were averaged over a period of 3 full days and nights. A negative change from Baseline indicates improvement|Baseline, during treatment (Days 7, 14, 20, 28) and during follow-up (Weeks 1, 2, 4, 8, 12)|Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations. 2 participants did not have data at Week 8 and 12 Follow-up.|||voids||Standard Deviation|Mean
2628262|NCT01879683|Secondary|Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain|Participants rated symptom bladder pain averaged over the previous 3 days using an 11-point numeric rating scale where: 0=no pain to 10=worst pain imaginable. A negative change from Baseline indicates improvement.|Baseline, during treatment (Days 7, 14, 20, 28) and during follow up (Weeks 1, 2, 4, 8, 12)|Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations. 2 participants did not have data at Week 8 and 12 Follow-up.|||score on a scale||Standard Deviation|Mean
2628263|NCT01879683|Primary|Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14|The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR)=presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either: i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.|Baseline, Day 14|Per protocol population included all participants who retained each LiRIS for both 14-day treatment periods and then completed the 4-week follow-up visit without any major protocol deviations.|||percentage of participants|||Number
2628264|NCT01879618|Secondary|Mean Percent of HD Sessions With an Acceptable Dose|A HD session with an acceptable dose is defined in terms of efficacy of the drug: an HD session for which the dose at the next HD session did not need to be changed due to Grade 3 or 4 clotting, bleeding, access compression time > 10 minutes, or other clinical event. The point estimate and 95% CI were computed based on GEE model for clustered binomial.|20 HD sessions (up to 4 hours)|FAS was used for all efficacy analyses which included all participants who received at least one dose of study medication. For this endpoint, there were 2630 evaluable HD sessions from 148 participants.|||Percentage of HD sessions||95% Confidence Interval|Mean
2628265|NCT01879618|Primary|Mean Percent of Successful HD Sessions|A successful HD session is defined in terms of efficacy of the drug where the HD session had completed as planned: there was no premature termination due to Grade 3 or 4 clotting or saline flush to prevent the loss of the extracorporeal circuit due to clotting; it was not possible to return the participant's blood or assess the exact extent of clotting. HD sessions which terminated prematurely due to Grade 1 or 2 clotting, safety event, machine failure, or access site displacement were excluded from the analysis. The point estimate and 95% CI were computed based on generalized estimating equation (GEE) model for clustered binomial data.|20 HD sessions (up to 4 hours)|The Full Analysis Set (FAS) was used for all efficacy analyses which included all participants who received at least one dose of study medication. There were 2776 HD sessions from 151 participants included in the primary analysis.|||Percentage of HD Sessions||95% Confidence Interval|Mean
2628266|NCT01879579|Other Pre-specified|Qualitative Patient Satisfaction Interview|The study staff will interview MITI arm patients, using free-response questions, to assess their satisfaction with the intervention. The interviews will take place in person or over the phone at the patient's convenience, after the patient has reached his/her optimal insulin dose. If the patient does not reach optimal insulin dose, the interview will take place at approximately 12 weeks.|After patient reaches optimal insulin dose or at 12 weeks|||||||
2628267|NCT01879579|Other Pre-specified|Costs - Co-pays|At baseline, participants in both study arms (MITI and CBP) reported whether they had to pay co-pays for clinic visits at Bellevue Hospital.|baseline||||participants|||Number
2628268|NCT01879579|Other Pre-specified|Costs - Patient Travel Time|The time it took patients to travel to Bellevue Hospital, reported by patients in both study arms at baseline and at any subsequent clinic visits.|12 weeks||||minutes||Inter-Quartile Range|Median
2628307|NCT01879319|Secondary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2628272|NCT01879579|Other Pre-specified|Percentage of Successful Phone Calls|The number of successful insulin titration phone calls compared to the total number of insulin titration phone calls assigned to the nurse. Successful phone calls are defined as when the nurse was able to reach the participant with one call attempt, two call attempts, or by voicemail. This outcome is given as a percent.|12 weeks|Participants who completed the allocated intervention.|||percentage of phone calls|Participants||Number
2628273|NCT01879579|Other Pre-specified|Percentage of Text Message Responses|The number of text message replies from participants compared to the total number of text messages sent to participants (asking for blood glucose values). This outcome is given as a percent.|12 weeks|Participants who completed the allocated intervention.|||percentage of text messages|Participants||Number
2628274|NCT01879579|Secondary|Incidence of Hypoglycemia|The number of instances of hypoglycemia as indicated by fasting blood glucose levels or symptoms reported by patients in both study arms.|12 weeks|This outcome was analyzed for participants who completed the allocated intervention (and the participant who discontinued insulin early due to a mild possible allergy). Five participants reported hypoglycemia: 3 in the MITI arm and 2 in the CBP arm. All cases were mild.|||instances of hypoglycemia|||Number
2628275|NCT01879579|Secondary|Change in Treatment Satisfaction|The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) will be used to measure the change in the patient's satisfaction with his/her diabetes treatment since initiation of long-acting insulin titration. Scores on questionnaire range from -3 to +3: -3 = much less satisfied now, +3 = much more satisfied now.|12 weeks (approximately 3 months)|All participants who completed the treatment satisfaction questionnaire at 12 weeks.|||score on satisfaction scale||Standard Deviation|Mean
2628276|NCT01879579|Secondary|Treatment Satisfaction After Initiation of Insulin Titration|The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient's satisfaction with diabetes treatment received since initiation of long-acting insulin titration. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied.|12 weeks (approximately 3 months)|All participants who completed the treatment satisfaction questionnaire at 12 weeks.|||score on satisfaction scale||Standard Deviation|Mean
2628277|NCT01879579|Secondary|Baseline Treatment Satisfaction|The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient's satisfaction with diabetes treatment received prior to study participation. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied.|baseline|All participants who completed the treatment satisfaction questionnaire at baseline.|||score on satisfaction scale||Standard Deviation|Mean
2628278|NCT01879579|Secondary|Hemoglobin A1c|Change in hemoglobin A1c|baseline, 12 weeks (approximately 3 months)|All participants with hemoglobin A1c measurements recorded at baseline and 12 weeks.|||mg/dL||Standard Deviation|Mean
2628279|NCT01879579|Secondary|Time to Reach Optimal Long-acting Insulin Dose|The time it takes a patient to reach his/her optimal long-acting insulin dose will be measured for both study arms.|12 weeks|Participants who reached optimal long-acting insulin dose.|||weeks||Inter-Quartile Range|Median
2628280|NCT01879579|Primary|Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose||12 weeks|No primary outcome data available for one participant in Current Best Practice arm who discontinued insulin early due to a mild possible allergy.|||percentage of participants|||Number
2628281|NCT01879553|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIV|The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (Day 1 to Day 22), after receiving one dose of TIV is reported.|Day 1 through Day 22 post vaccination|Analysis was done on the unsolicited safety set population i.e all subjects who have post vaccination unsolicited adverse event data|||Number of subjects|||Number
2628282|NCT01879553|Primary|Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV|The number of adult and elderly subjects reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of TIV are reported.|Day 1 to Day 4 post vaccination||||Number of subjects|||Number
2628283|NCT01879553|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV|"The antibody responses following one dose of TIV were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 for subjects aged ≥61 years."|Day 22 (postvaccination)/ Day 1 (baseline)|Analysis was done on the per-protocol population|||Ratio||95% Confidence Interval|Geometric Mean
2628284|NCT01879553|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIV|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIV.~Seroconversion is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 to at least a 4-fold increase in post vaccination HI antibody titers.~The related European (CHMP) criterion for the assessment of immunogenicity is met if >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination HI titers."|Day 22 (postvaccination) / Day 1 (baseline)|Analysis was done on the per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
2628285|NCT01879553|Primary|Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 (baseline) and Day 22 (postvaccination)|Analysis was done on the per-protocol population.|||Percentages of subjects||95% Confidence Interval|Number
2628586|NCT01876446|Secondary|Median Overall Survival|The distribution of survival time was be estimated in each group using the method of Kaplan-Meier.|Time from registration to death due to any cause, assessed up to 3 years|All treated and eligible patients|||months||95% Confidence Interval|Median
2628286|NCT01879553|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIV|"The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is >2.5 for adults aged 18 to ≤60 years and > 2.0 in for subjects aged ≥61 years."|Day 22 (postvaccination) / Day 1 (baseline)|Analysis was done on the per-protocol population|||Ratio||95% Confidence Interval|Geometric Mean
2628287|NCT01879553|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIV|"Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains, three weeks after receiving one dose of TIV.~Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤4mm2 achieving a post vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area >4mm2 achieving at least 50% increase in post vaccination SRH area.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >40% for adults aged 18 to ≤60 years and >30% for subjects aged ≥61 years."|Day 22 (postvaccination) /Day 1 (baseline)|Analysis was done on the per-protocol population|||Percentages of subjects||95% Confidence Interval|Number
2628288|NCT01879553|Primary|Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV|"Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIV .~The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >70% for adults aged 18 to ≤60 years and >60% for subjects aged ≥61 years."|Day 1 (baseline) and Day 22 (postvaccination)|Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have RT-PCR confirmed influenza during the study|||Percentage of subjects||95% Confidence Interval|Number
2628289|NCT01879540|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of aTIV|The number of adult subjects ≥65 years of age subjects reporting any unsolicited adverse event (AEs) between Day 1 to 4 and serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study between Day 1 to Day 22 after receiving one dose of aTIV are reported.|Day 1 to Day 22 post-vaccination|Analysis was done on the unsolicited safety set population i.e all subjects who had post-vaccination unsolicited AE records|||Participants|||Number
2628290|NCT01879540|Primary|Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of aTIV|The number of adult subjects ≥65 years of age reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of aTIV are reported.|Day 1 to Day 4 post vaccination|Analysis was done on the safety set population i.e all subjects who have post-vaccination AE or reactogenicity records|||Participants|||Number
2628291|NCT01879540|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination HI Titers, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"The antibody responses following one dose of aTIV were evaluated in terms of GMRs of post vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of aTIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is > 2.0."|Day 22/Day 1|Analysis was done on the per-protocol population|||Ratio||95% Confidence Interval|Geometric Mean
2628292|NCT01879540|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age achieving seroconversion or significant increase in HI antibody titers after receiving one dose of aTIV.~Seroconversion is defined as percentage of subjects with a pre-vaccination HI titer <10 to a post-vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre-vaccination HI titer ≥10 to at least a 4-fold increase in post-vaccination HI antibody titers.~The related European (CHMP) criterion for the assessment of immunogenicity is met if >30% of subjects achieve seroconversion or significant increase in post-vaccination HI titers."|Day 22|Analysis was done on the per-protocol population|||Percentage of subjects||95% Confidence Interval|Number
2628293|NCT01879540|Primary|Percentages of Subjects With Haemagglutinin Inhibition(HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV.|"Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of aTIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the of subjects achieving HI titers ≥ 40 is >60%."|Day 1 (baseline) and Day 22|Analysis was done on the per-protocol population|||Percentage of subjects||95% Confidence Interval|Number
2628294|NCT01879540|Primary|Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"The antibody responses following one dose of aTIV were evaluated in terms of geometric mean ratio GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of aTIV.~The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is > 2.0."|Day 22/Day 1|Analysis was done on the per-protocol population|||Ratio||95% Confidence Interval|Geometric Mean
2628308|NCT01879319|Primary|Percentage of Participants With Full Administration of Evolocumab at Both Weeks 4 and 8|Self-administration of evolocumab was assessed by a telephone interview at Weeks 4 and 8. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all. Results only include full administrations that occurred inside the prespecified visit window.|Weeks 4 and 8|Full analysis set|||Percentage of participants||95% Confidence Interval|Number
2628309|NCT01879176|Primary|IL-6||1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours||||pg/ml||Inter-Quartile Range|Median
2633478|NCT01824446|Primary|Plasma Half-Life (T1/2) of Radiolabelled SSP-004184|The time it takes for the blood plasma concentration of a substance to halve.|Up to 288 hours post-dose|PAS|||hours||Standard Deviation|Mean
2628295|NCT01879540|Primary|Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age achieving seroconversion or significant increase in SRH area against each of the three vaccine strains, three weeks after receiving one dose of aTIV.~Seroconversion is defined as percentage of subjects with a pre-vaccination SRH area ≤4mm2 achieving a post-vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area >4mm2 achieving at least 50% increase in post-vaccination SRH area.~The related European (CHMP) criterion for the assessment of immunogenicity is met if>30% of subjects achieve seroconversion or significant increase in post-vaccination SRH area."|Day 22|Analysis was done on the per-protocol population|||Percentage of subjects||95% Confidence Interval|Number
2628296|NCT01879540|Primary|Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of aTIV|"Immunogenicity was assessed in terms of percentages of adult subjects ≥65 years of age with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of aTIV.~The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is >60%."|Day 1 (baseline) and Day 22|Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) confirmed influenza during the study.|||Percentage of subjects||95% Confidence Interval|Number
2628297|NCT01879410|Secondary|Change From Baseline(BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline is defined as the mean of the assessments made 30 and 5 minutes (min) pre-dose on treatment Day 1. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after morning dosing on Day 84. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the 2 assessments made 30 min and 5 min pre-dose on Day 1), smoking status, day, day by baseline and day by treatment interactions. The model used all available trough FEV1 values recorded on Days 28, 56, 84, and 85. Missing data were not directly imputed in this analysis; however, all non-missing data for a participant were used within the analysis to estimate the treatment effect for trough FEV1 at Day 85. Change from baseline was calculated as the value at Day 84 minus the value at Baseline.|Baseline and Day 85|ITT Population. Participants analyzed were those with data available at the presented time point; but, all participants without missing covariate information were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2628298|NCT01879410|Primary|Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Forced Expiratory Volume Over 1 Second (FEV1) at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 hours (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Baseline is defined as the mean of the assessments made 30 and 5 minutes (min) pre-dose on treatment Day 1. Analysis was performed using an analysis of covariance model with covariates of baseline FEV1 (mean of the two assessments made 30 mins and 5 mins pre-dose on Day 1), smoking status, and treatment. Change from baseline was calculated as the value at Day 84 minus the value at Baseline.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all randomized participants who received at least 1 dose of randomized study drug in the Treatment Period. Participants analyzed were those with data available at the presented time point; but, all participants without missing covariate information and with >= post BL measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2628299|NCT01879371|Secondary|AUC(0-inf)|AUC(0-inf): area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 extrapolated to infinity|2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration|PKS|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2628300|NCT01879371|Primary|Cmax|Cmax: maximum measured concentration of Ibuprofen in plasma|2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration|PKS|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2628301|NCT01879371|Primary|AUC(0-tz)|AUC(0-tz): area under the concentration-time curve of Ibuprofen in plasma over the time interval from 0 to the last quantifiable data point|2 hours (h) before drug administration and 5minutes (min), 10min, 15min, 30min, 45min, 1h, 1h 15min, 1h 30min, 1h 45min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h after drug administration|Pharmacokinetic set (PKS): included all treated subjects who provided at least one observation for at least one primary Pharmacokinetic endpoint without important protocol violations.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2628302|NCT01879345|Secondary|AUC0-τ|Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093|Day 1 and Day 7||||ng.h/mL||Standard Deviation|Mean
2628303|NCT01879345|Secondary|Tmax - the Time of Occurrence of Cmax|Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093|Day 1 and Day 7||||hours||Standard Deviation|Mean
2628304|NCT01879345|Secondary|Cmax - Maximum Observed Plasma Drug Concentration|"Single dose: pharmacokinetic parameters following an oral single-dose of BIA 2-093 Multiple dose: pharmacokinetic parameters following the last dose of an oral 7- day once-daily regimen of BIA 2-093~Oxcarbazepine is a BIA 2-093 metabolite"|Day 1 and Day 7||||ng/mL||Standard Deviation|Mean
2628305|NCT01879345|Primary|Number of Adverse Events Reported|investigate the tolerability of two single- and multiple-dose regimens of BIA 2-093 (1800 mg and 2400 mg)considering the Number of adverse events reported by patient|3 weeks||||Number of adverse events reported|||Number
2628306|NCT01879332|Primary|Number of Adverse Events Reported|Safety was evaluated through the recording and monitoring of adverse events|2 days||||Number of adverse events reported|||Number
2650844|NCT01665170|Secondary|ACTH (Pre-post Comparison)|ACTH - Adrenocorticotropes Hormon - 2 min. prior to and 1 min. after the TSST|1 day|||||||
2628311|NCT01879059|Primary|Effects of Physical Inactivity on Post Prandial Blood Flow|There was a pre-measurement period of 3 days, then 5 days of inactivity, followed by 1.5-2 days of return to activity. A 10 day time frame overall. Blood flow measured by Doppler ultrasound during an oral glucose tolerance test before and after 5 days of inactivity.|10 days|healthy, young, active men|||percentage of change in blood flow||Standard Deviation|Mean
2628312|NCT01878825|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|During the entire study period (Days 0-20 post vaccination)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
2628313|NCT01878825|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
2628314|NCT01878825|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [oral temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = oral temperature above 39.0°C|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
2628315|NCT01878825|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
2628316|NCT01878825|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2628317|NCT01878825|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
2628318|NCT01878825|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2628319|NCT01878825|Secondary|Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2012/2013 influenza season.|At Days 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2628638|NCT01876212|Secondary|EphA2 Protein Expression in Tumor Biopsies|Level of EphA2 protein expression in tumor tissue biopsies.|Up to 6 months|Results not achievable due to insufficient patient biopsy material for the assays required for this endpoint.||||||
2628320|NCT01878825|Primary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Days 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2628321|NCT01878825|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
2628322|NCT01878825|Primary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2628323|NCT01878825|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).|At Days 0 and 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2628324|NCT01878812|Secondary|Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Virus by Vaccination Status|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.|||Titers||95% Confidence Interval|Geometric Mean
2628325|NCT01878812|Secondary|Number of Seroconverted Subjects Against 4 Strains of Influenza Virus by Vaccination Status|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.|||Subjects|||Number
2628326|NCT01878812|Secondary|Number of Seroprotected Subjects Against 4 Strains of Influenza Virus by Vaccination Status|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.|||Subjects|||Number
2628327|NCT01878812|Secondary|Anti-HI Antibody Titers Against 4 Strains of Influenza Virus by Vaccination Status|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs). Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.|At Days 0 and 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.|||Titers||95% Confidence Interval|Geometric Mean
2628328|NCT01878812|Secondary|Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|At Days 0 and 21||||Subjects|||Number
2628341|NCT01878786|Secondary|Compare Renal Function of the Everolimus Treatment Arms to the MMF/MPA Treatment Arm at 12 and 24 Months Post-transplantation|The key secondary objective is to compare renal function of the everolimus treatment arms to the MMF/MPA treatment arm at 12 and 24 months post-transplantation. Renal function will be measured by the calculated glomerular filtration rate (GFR), using the MDRD (Modification of Diet in Renal Disease) formula (20).|24 months|Study was terminated prematurely. There was no data analysis performed on the incomplete data set.||||||
2635817|NCT01798706|Secondary|Percentage of Participants With Gastrointestinal Disorders||Up to Day 171|Analysis was performed on safety population.|||percentage of participants|||Number
2628329|NCT01878812|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)||||Subjects|||Number
2628330|NCT01878812|Secondary|Number of Days of Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)],. Any = occurrence of the symptom regardless of intensity grade. The number of days is expressed as a mean value.|During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered with the respective symptoms reported.|||Days||Inter-Quartile Range|Mean
2628331|NCT01878812|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)],. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)||||Subjects|||Number
2628332|NCT01878812|Secondary|Number of Days of Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. The number of days is expressed as a mean value.|During the entire study period (Days 0 to 21)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered with the respective symptoms reported.|||Days||Inter-Quartile Range|Mean
2628333|NCT01878812|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During a 21-day follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)||||Subjects|||Number
2628334|NCT01878812|Primary|Seroprotection Powers (SPP) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. SPP is defined as the percentage of subjects who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.|During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.|||Percentage of subjects|||Number
2628335|NCT01878812|Primary|Mean Geometric Increase (MGI) for HI Antibody Titer Against the 4 Flu Strains of Influenza Disease|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.|||Fold increase||95% Confidence Interval|Geometric Mean
2628336|NCT01878812|Primary|Number of Seroconverted Subjects Against 4 Strains of Influenza Disease|The strains are: Flu A/Christchurch/16/2010 H1N1 HI,(referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.|||Subjects|||Number
2628337|NCT01878812|Primary|Number of Seroprotected Subjects Against 4 Strains of Influenza Disease|The strains are: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI,(referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40.|At Day 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.|||Subjects|||Number
2628338|NCT01878812|Primary|Anti-HI Antibody Titers Against 4 Strains of Influenza Disease|The strains assessed were: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) ,Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs).|At Days 0 and 21|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects with results available at the specified timepoint.|||Titers||95% Confidence Interval|Geometric Mean
2628339|NCT01878799|Primary|Percentage of Participants With Achieved SVR12 (HCV RNA <LLOQ 12 Weeks After Completion of Treatment)|The primary end point was sustained virologic response [plasma HCV RNA level <12 IU/mL by real-time HCV assay (Abbott)] at 12 weeks after treatment completion (SVR12) among all patients enrolled in the study.|12 weeks after completion of treatment|The analysis included all subjects who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2628340|NCT01878786|Other Pre-specified|Incidence of Cytomegalovirus (CMV) (Viremia or Viruria)||24 months|Study was terminated prematurely. There was no data analysis performed on the incomplete data set.||||||
2635871|NCT01798225|Primary|Periodontal Pocket Probing Depth (PD)||Change between baseline to 6-month post-treatment||||mm||Standard Error|Mean
2628342|NCT01878786|Primary|Evaluate Concentration-controlled Everolimus and Low Dose Tacrolimus Compared to MMF/MPA With Standard Dose Tacrolimus at 24 Months|The primary objective of this study is to evaluate concentration-controlled everolimus and low dose tacrolimus compared to MMF/MPA with standard dose tacrolimus at 24 months post-transplant with respect to the composite efficacy failure rates (treated biopsy proven acute rejection episodes (BPAR), graft loss, death, loss to follow-up) in de novo renal transplant recipients.|24 months|Study was terminated prematurely. There was no data analysis performed on the incomplete data set.||||||
2628343|NCT01878656|Other Pre-specified|Sense of Suffocation|The outcomes assessor will evaluate the sense of suffocation using a numeric rating scale(NRS). (0 = no sense of suffocation, 10 = unimaginably severe sense of suffocation)|Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.|||||||
2628344|NCT01878656|Other Pre-specified|Postoperative Pain|The outcomes assessor will evaluate the degree of postoperative pain using a numeric rating scale (NRS). (0 = no pain, 10 = unimaginable severe pain)|Participants will be followed for the duration of postanesthesia care unit (PACU) stay, an expected average of 1 hour.|||||||
2628345|NCT01878656|Secondary|The Time to Extubation|We will evaluate the time from gas discontinuation to extubation. We will conduct an extubation when participants can show responses such as eye opening or nodding one's head to our verbal commands.|Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.|||||||
2628346|NCT01878656|Primary|The Incidence of Emergence Agitation Using Four-point Categorical Scale|The outcomes assessor will evaluate the severity of emergence agitation of participants using a four-point categorical scale. (1: calm, 2: not calm, but could be easily calmed, 3: moderately agitated or restless, 4: combative, excited, disoriented) We considered presence of emergence agitation as 3 and 4 of four-point scale.|Participants will be followed from the time of gas discontinuation in operating room to the time of discharge from postanesthesia care unit(PACU), an expected average of 1 hour.||||participants|||Number
2628347|NCT01878604|Secondary|LDL-C Reduction Percentage|"plasma LDL-C reduction percentage with lipid-lowering drugs from pre-treatment to the last time follow-up time point~plasma LDL-C reduction percentage calculation: plasma LDL-C at pre-treatment time point minus plasma LDL-C at the last time follow-up time point, and then compared with plasma LDL-C at pre-treatment time point, namely plasma LDL-C reduction percentage."|pre-treatment and 6-13 years post treatment||||percentage of plasma LDL-C reduction||Standard Error|Mean
2628348|NCT01878604|Primary|Number of LDLR Gene Mutations|"Number of gene mutations based on the sequencing results in terms of some known genes and suspected novel genes.~c.796 G>C and c.1048 C>T in the LDLR gene c.1448 G>A and c.1720C>A in the LDLR gene c.2030 G >A and c.1257 C>A in the LDLR gene homozygous mutation c.605 T>C in the LDLR gene"|1 year||||gene mutations|||Number
2628349|NCT01878526|Secondary|Changing of the Quality of Life Which is Evaluated by EQ-5DTM|VAS scale 0-100 was applied for an outcome measurement of the quality of life. The VAS scale 0 was the worst quality of life and scale 100 was the best quality of life. The changing of the quality of life was the changing of VAS of quality of life before and after treatment.|8 weeks||||VAS (100)||Standard Deviation|Mean
2628350|NCT01878526|Secondary|the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole||4 weeks|The number of analysed patients came out the total number of screening patients in the trial. The patients who were defined as omeprazole-resistant GERD were enrolled and randomized for either alginic acid plus placebo or domperidone plus placebo group.|||percentage of participants||95% Confidence Interval|Number
2628351|NCT01878526|Secondary|Changing of Frequency of Symptoms in SSc Related Omeprazole Resistant GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG)|Unit scale 0-48 was applied for an outcome measurement of the frequency of symptoms. The unit scale 0 was no symptom and scale 48 was usual symptom of GERD. The changing of the frequency of symptoms was the changing of the unit scale before and after treatment.|8 weeks||||units on a scale||Standard Deviation|Mean
2628352|NCT01878526|Primary|Changing of the Severity of Regurgitation|VAS scale 0-100 was applied for an outcome measurement of the severity of regurgitation. The VAS scale 0 was no symptoms of regurgitation and scale 100 was a maximum symptom of regurgitation. The changing of the severity of regurgitation was the changing of VAS before and after treatment.|8 weeks||||VAS (100)||Standard Deviation|Mean
2628353|NCT01878526|Primary|Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS)|VAS scale 0-100 was applied for an outcome measurement of the severity of heart burn. The VAS scale 0 was no symptoms of heart burn and scale 100 was a maximum symptom of heart burn. The changing of the severity of heart burn was the changing of VAS before and after treatment.|8 weeks||||VAS (100)||Standard Deviation|Mean
2628354|NCT01878292|Secondary|Change in Clinical Global Impressions-Severity (CGI-S) Score|The Clinical Global Impressions-Severity (CGI-S) is a clinician-rated instrument used to rate the severity of the patient's current state of mental illness compared with the clinician's total experience with patients with major depressive disorder (MDD). The severity of the patient's MDD was rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating a patient who is among the most extremely ill patients.|From Baseline to Week 8|The Intent-to-Treat (ITT) Population will consist of all patients in the Safety Population who had baseline and at least 1 postbaseline assessment of the Children’s Depression Rating Scale-Revised (CDRS-R) total score.|||units on a scale||Standard Error|Least Squares Mean
2628355|NCT01878292|Primary|Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score|The Children's Depression Rating Scale-Revised (CDRS-R) total score ranges from 17 (minimal or no symptoms of depression) to 133 (indicative of depression) is a semi-structured, clinician-rated instrument designed for use with children and adolescents between the ages of 6 to 17 years of age and their caregivers. The CDRS-R evaluates the presence and severity of symptoms commonly associated with depression in childhood.|From Baseline to week 8|The Intent-to-Treat (ITT) Population will consist of all patients in the Safety Population who had baseline and at least 1 postbaseline assessment of the Children’s Depression Rating Scale-Revised (CDRS-R) total score.|||units on a scale||Standard Error|Least Squares Mean
2628652|NCT01876212|Secondary|Worst Grade of Any Toxicity|Number of participants and severity grades for treatment-relatedness scores of possibly, probably, or definitely.|Up to 2 years|Patients that received at least one dose of study treatment who experienced a treatment-related toxicity .|||Participants|||Count of Participants
2628356|NCT01878253|Secondary|SF-12 Mental Health and Physical Composite Scores as Measured by the SF-12 Scoring Questionnaire.|SF-12 Mental Health and Physical Composite Scores. SF-12 is a validated health survey that uses 12 questions to measure functional health and well being from the patient's point of view. The SF-12 is calculated on a scale of 0 to 100, where a 0 is the worst level of health and 100 is the best level of health. The scores are then normalized with a mean score of 50 and a standard deviation of 10, so that scores greater than 50 represent a health level better than average, and scores less than 50 represent a level lower than average.|Pre-Op, 6 weeks, 6 months, 1 year and 2 years|SF-12 Mental Health and Physical Composite Scores. 95 subjects had data Pre-operatively, 94 at 6 weeks, 90 at 6 months, 88 at 1 year and 86 at 2 years. One subject at the 6 weeks interval had completed the physical portion of the SF-12 but did not complete all requirements to calculate the SF-12 Mental Score.|||score on a scale||Standard Deviation|Mean
2628357|NCT01878253|Secondary|ASES Functional and Pain Scores at Intervals Other Than 2 Years as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire|Pain and function as measured by the American Society of Shoulder and Elbow Surgeons questionnaire. ASES consists of 3 subcomponent scores including pain, instability and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3. 3 involves no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best.|6 weeks, 6 months, and 1 year|ASES Functional Score Summary and Pain Scores. 95 Participants had ASES data at 6 weeks, 90 at 6 months and 88 at 1 year. At 6 weeks 1 subject was missing data required to calculate the ASES functional score, had pain score data present.|||score on a scale||Standard Deviation|Mean
2628358|NCT01878253|Primary|Survivorship|The Kaplan-Meier method was used for this study. This outcome measures survivorship of the implanted devices from the date of implantation to the date of revision or intended revision up to 2 years post-operative (whichever came first).|Up to Two years|At the two year study endpoint there were 86 subjects that had data available at the two year time point.|||Participants|||Count of Participants
2628359|NCT01878253|Primary|The Number of Device Related Serious Adverse Events.|This outcome will measure the frequency of device related serious adverse events.|Two years|This outcome will measure the frequency of device related serious adverse events. At the two year endpoint of the study there were a total of 86 participants with available data.|||Device Related Serious Adverse Events|||Number
2628360|NCT01878253|Primary|Absence of Radiographic Evidence of Failure or Pending Failure Based on Radiographic Assessment|"absence of radiographic evidence of pending failure of the humeral components, assessed at 2 years which may include the following:~implant fracture~progressive implant migration or subsidence ≥ 5 mm"|Two years|Participants who had received the implant. 85 subjects had radiographic images available at the 2 year time point.. Radiographies were assessed at 2 years for implant fracture, failure of humeral components and progressive implant migration or subsidence greater or equal to 5 mm.|||Participants|||Count of Participants
2628361|NCT01878253|Primary|Pain and Function as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire|Pain and function as measured by the American Society of Shoulder and Elbow Surgeons questionnaire. ASES consists of 3 subcomponent scores including pain, instability and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3. 3 involves no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best.|Two years|All participants received the implant as treatment. ASES Functional Score Summary and Pain Scores.|||score on a scale||Standard Deviation|Mean
2628362|NCT01878214|Secondary|Changes in Motivation to Quit Smoking and Thinking About Quitting Smoking|"At baseline and follow-up, subjects will answer questions about motivation to quit smoking (How motivated are you to quit smoking at this time? [scale: 1 (not at all) - 10 (extremely)]) and thinking about quitting smoking (Each rung on this ladder represents where various smokers are in their thinking about quitting. Circle the number that indicates where you are now. [0 (no thoughts of quitting) -10 (taking action to quit)]). We will report the % of subjects who reported more motivation to quit and greater thinking about quitting at follow-up compared to baseline. We will compare the intervention group with the control group."|7 months after recruitment|Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey. This outcome was only measured in those who reported smoking in the last 30 days (n=288, 83.5%).|||percentage of participants|||Number
2628363|NCT01878214|Secondary|Changes in Readiness to Quit Smoking in the Next 6 Months|"Subjects will answer the following question at both baseline and follow-up surveys: Are you seriously considering quitting smoking in the next 6 months? [yes/no]. We will report % of subjects who said no at baseline and yes at follow-up to determine changes in readiness to quit smoking and compare between intervention and control groups."|7 months after recruitment|Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey. This outcome was only measured in those who reported smoking in the last 30 days (n=288, 83.5%).|||percentage of participants|||Number
2628364|NCT01878214|Secondary|Changes in Smoking Behaviors (Frequency and Quantity)|"At baseline and follow-up, subjects will report smoking frequency (How often do you smoke? [everyday, at least 4 days/week, 1-3 days/week, less than one day/week]) and quantity (On days that you smoke, how many cigarettes do you have per day? [10 or less, 11-20, 21-30, 31 or more]). We will report the % of subjects who smoke less frequently and smoke fewer cigarettes per day at follow-up compared to baseline. We will compare the intervention group with the control group."|7 months after recruitment|Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey. This outcome was only measured in those who reported smoking in the last 30 days (n=288, 83.5%).|||percentage of participants|||Number
2628694|NCT01875237|Other Pre-specified|To Assess Presence of Gvhd Post Donor Lymphocyte Infusion (DLI)|To assess at 6 months post donor lymphocyte infusion (DLI): GVHD grade & time to resolution|6 months|Patient who received DLI was removed from study prior to 6 month time frame. No outcome measure was provided.||||||
2628365|NCT01878214|Secondary|Quit Smoking|"At follow-up, subjects will report current smoking status. (Do you currently smoke (have you smoked in the last 30 days)? [Yes, I smoked within the past 30 days; No, but I have smoked in the past 6 months; No, and I have not smoked in more than 6 months]). We will report the % of subjects who have not smoked in the last 30 days and will compare the intervention group with the control group."|7 months after baseline|Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey.|||percentage of participants|||Number
2628366|NCT01878214|Primary|Enrollment in Smoking Cessation Program|Enrollment records from the union-sponsored smoking cessation program|up to 12 months after recruitment|Includes all study subjects|||participants|||Number
2628367|NCT01878175|Secondary|Change in Lower Quarter Y-balance Test (YBT-LQ)|The YBT-LQ is a test of dynamic balance in unilateral stance . It will be administered to all patients who pass a clearance test, which consists of being able to stand on one leg for 10 seconds. The YBT-LQ is performed for both left and right limbs. Any trial that is failed will be repeated with a maximum of 4 additional trials to be performed in each reach direction, anterior, posterior, and lateral. NOTE: Only although 13 participants began the clearance test at both time points, only 5 participants were able to pass the clearance test required to do the YBT-LQ at 6 weeks. Therefore we have not provided a change score for YBT-LQ since this would involve a very small number of participants, and we are concerned about validity of the results that would be presented since those who completed the test at 6 weeks may be a biased sample. We therefore provide the difference (post minus pre) in the # of participants who completed the clearance test at 15 weeks (9) vs. 6 weeks (5).|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who performed the clearance test for the YBT-LQ at both 6 weeks and 15 weeks.|||Number of participants|||Number
2628368|NCT01878175|Secondary|Change in Harris Hip Score (HHS)|The HHS is the most widely used physician- or therapist-assessed measure of hip function following THA and associated rehabilitation. Although the HHS has also been used in a patient-report format, in this study we will obtain this measure via therapist report, to complement the patient-reported outcomes described above. This measure covers the domains of pain (severity and effects on activities and need for pain medication, function (daily activities and gait), deformity (hip flexion, adduction, internal rotation, and extremity length discrepancy) and range of motion (hip flexion, abduction, internal and external rotation, and adduction). The HHS includes 10 items, with a total score range of 0-100; higher scores indicating better function. The HHS has been shown to be a reliable and valid measure of hip function. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the test at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.|||units on a scale||Standard Deviation|Mean
2628369|NCT01878175|Secondary|Change in University of California Los Angeles (UCLA) Activity Questionnaire|The UCLA scale shows a strong correlation with the other measures (r = -0.35 to 0.56 for THA; r = -0.55 to 0.23 for TKA) and discriminates between insufficiently and sufficiently active patients undergoing THA and TKA. The UCLA scale has good reliability, provides high completion rate, and shows no floor effects. It seems to be the most appropriate scale for assessment of physical activity levels in patients undergoing total joint arthroplasty. The UCLA scale is a simple scale ranging from 1 to 10. The patient indicates her or his most appropriate activity level, with 1 defined as 'no physical activity, dependent on others' and 10 defined as 'regular participation in impact sports.' Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the test at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.|||units on a scale||Standard Deviation|Mean
2628370|NCT01878175|Secondary|Change in Objective Functional Test: Stair Climbing|The task of stair climbing has been found to be sensitive to change with interventions in individuals with knee OA. This measures the time it takes a participant to ascend and descend a flight of 12 steps (each step 18 cm high and 28 cm deep). Participants will be asked to complete the test as quickly as they felt safe and comfortable. The use of one handrail will be allowed if necessary, but patients will be encouraged to minimize their use of the handrail. One practice trial will be performed and the average of two additional tests will be used for analysis. The use of an assistive device will be allowed only if the subject will be unsafe or cannot complete the test without the use of the device. Change was defined as pre-intervention minus post-intervention. Therefore a positive change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed this measure at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and one additional participant did not complete this test at both time points.|||seconds||Standard Deviation|Mean
2628371|NCT01878175|Secondary|Change in Objective Functional Test: Walking Speed|Gait speed is a global measure of disability and function and has been correlated with disease processes, fitness level, activities of daily living, and emotional states. In addition, gait speed is an imperative measure for integration to safe and effective community ambulatory status, and has been defined as a reflective measure of function. Walking speed will be determined as the average walking speed over a 3 meter walk. Participants will be asked to walk down a 10 meter walkway 7 times (while wearing standard footwear) to have their walking speed monitored using infrared photocells, while speed is monitored over the middle 3 meters. These seven trials will be averaged in order to determine walking speed at each of the three visits. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed this test at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and one additional participant did not complete this test at both time points.|||m/sec||Standard Deviation|Mean
2628472|NCT01877642|Secondary|Relative Pharmacodynamic Effect on Pulse Oximetry for Combined vs Individual (Lorazepam, Loxapine)|LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for pulse oximetry following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone|24 hours|Pharmacodynamic population|||percentage of effect on control drug||90% Confidence Interval|Geometric Least Squares Mean
2628372|NCT01878175|Secondary|Change in Objective Functional Test: Sit to Stand|The Sit-to-Stand Test has been reported to be a good indicator of postural control, fall risk, lower-extremity strength, and disability. During the sit-to-stand test participants will be asked to place their arms across their chest and keep their feet flat on the floor. They will then be asked to stand up and sit down 5 times as fast as they can. This will be repeated twice and the scores will be averaged for analysis. Change was defined as pre-intervention minus post-intervention. Therefore a positive change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed this test at 6 and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and two additional participants did not complete this test at both time points.|||seconds||Standard Deviation|Mean
2628373|NCT01878175|Secondary|Change in Objective Functional Test: Timed Get Up-and-go|The timed get up-and-go test has demonstrated excellent reliability and correlates well with other standard measures such as gait speed, self-report and clinical report indices of function, and is predictive of who can safely ambulate. This test requires the participants to stand from a standard arm chair, walk 3 meters and then return to sitting in the same chair. Participants are asked to complete this as quickly and safely as possible, without the use of an assistive device. Change was defined as pre-intervention minus post-intervention. Therefore a positive change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed this test at both 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and one additional participant did not complete this assessment at both time points.|||seconds||Standard Deviation|Mean
2628374|NCT01878175|Secondary|Global Assessment of Hip Symptom Change|We will use the Patient Global Impression of Change scale to evaluate participants' perspectives on overall change in their joint pain in their (one) operative hip during the study period. This single-item measure asks participants to describe their change in pain on a rating scale with the following 13 options: a little worse, somewhat worse, moderately worse, a good deal worse, a great deal worse, a very great deal worse, about the same, a little better, somewhat better, moderately better, a good deal better, a great deal better, a very great deal better. The total scale range is -6 to +6. Negative scores indicate greater perceived improvement.|15 weeks (post-intervention)|Number of participants who completed this measure at 15 week follow-up. Two participants were withdrawn from the study before 15 weeks, and two additional participants did not complete this item at the 15 week follow up assessment.|||units on a scale||Standard Deviation|Mean
2628375|NCT01878175|Secondary|Change in Satisfaction With Physical Function Questionnaire|This is a validated 5-item questionnaire that assesses patients' satisfaction with their ability to complete basic functional tasks that are often affected by lower extremity osteoarthritis (OA), including stair-climbing, walking, doing housework (light and heavy), and lifting and carrying. The scale range is -15 to +15, with higher scores indicating more satisfaction with function. Change was defined as post-intervention minus pre-intervention. Therefore a positive change score indicates improvement over time.|Change between Pre-intervention (post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the measure at baseline and 15 weeks. Two participants were withdrawn before 15 weeks.|||units on a scale||Standard Deviation|Mean
2628376|NCT01878175|Primary|Change Hip Disability and Osteoarthritis Outcomes (HOOS) - Quality of Life Subscale|The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the HOOS Quality of Life scale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.|||units on a scale||Standard Deviation|Mean
2628377|NCT01878175|Primary|Change in Hip Disability and Osteoarthritis Outcomes (HOOS) Score - Symptom Subscale|The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the HOOS Symptoms subscale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.|||units on a scale||Standard Deviation|Mean
2628378|NCT01878175|Primary|Change in Hip Disability and Osteoarthritis Outcomes (HOOS) Score - Sport Subscale|The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the HOOS Sport subscale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks, and one additional participant did not complete all items on this subscale at both time points and therefore could not be given a score, per scale scoring instructions.|||units on a scale||Standard Deviation|Mean
2628501|NCT01877265|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2605541|The maximum observed drug concentration (Cmax) of LY2605541 is summarized for each PEG source (LY1, LY2, or LY3).|Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post dose in each period|Participants who received at least 1 dose of LY2605541 and had evaluable LY2605541 concentration data.|||picomoles per liter||Geometric Coefficient of Variation|Geometric Mean
2628379|NCT01878175|Primary|Change in Hip Disability and Osteoarthritis Outcomes Score (HOOS) - Pain Scale|The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Number of participants who completed the HOOS pain subscale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.|||units on a scale||Standard Deviation|Mean
2628380|NCT01878175|Primary|Change in Hip Disability and Osteoarthritis Outcomes Score (HOOS) - Activities of Daily Living Scale|The HOOS is a validated outcome measure in patients with painful hip conditions. It contains 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Change was defined as pre-intervention minus post-intervention. Therefore a negative change score indicates improvement over time.|Change between Pre-intervention (6 weeks post-surgery) to post-intervention (15 weeks post-surgery)|Individuals who completed the HOOS ADL scale at 6 weeks and 15 weeks. Two participants were withdrawn from the study before 15 weeks.|||units on a scale||Standard Deviation|Mean
2628381|NCT01878149|Secondary|Safety|Incidence of short term peri-operative adverse events (out to 6 months post-implant) including thigh pain, numbness, paresthesia and transient leg weakness.|Observed for up to 6 months post-surgery|||||||
2628382|NCT01878149|Primary|Safety: Number of Participants Without Major Device-related Adverse Events and/or Failures|Incidence of major device-related adverse events and/or failures, defined as those requiring revision surgery or a secondary operation, or events resulting in permanent disability or death.|Observed for up to 6 months post-surgery|It was anticipated that approximately 40 subjects would be enrolled across the participating sites; 20 subjects in each treatment arm. Consecutive subjects who were treated with LLIF using the VEO® or XLIF® systems at least 3 months prior to the the data collection were included. The planned sample size was not statistically derived.|||participants|||Number
2628383|NCT01878097|Other Pre-specified|Increase in Bystanding Behaviors|"7 item survey measuring self-reports of students actively engaging their peers in behaviors that may prevent violence.~Response options: 0 times, 1-2 times, 3-5 times, 6-9 times, 10 or more times, didn't see or hear someone doing this~Above items repeated to measure student observing others doing these behaviors. Data will be presented as the total number of interventions were the bigger the number the more likely the bystander was to intervene on behalf of the victim."|Data will be collected at baseline and annually for 4 years.|||||||
2628384|NCT01878097|Other Pre-specified|Change in Violence Acceptance|"Illinois Rape Myth Acceptance Scale measure students' beliefs about rape which may indicate social norms supporting sexual violence. The scale consists of 22 questions scored 1 -5. Were 1 is strongly agree and 5 is strongly disagree. The higher the cumulative score, the more likely the participant is to accept rape myths.~5-item Acceptance of General Dating Violence Scale was used to measure norms supporting dating violence. Scores will range from 1-6, were the higher the score the more likely the participant was to reject dating violence as normal."|Data will be collected at baseline and annually for 4 years.|||||||
2628385|NCT01878097|Primary|Average Number of Sexual Assaults Experienced (Victimization) Events Per School.|Students self report of sexual assault victimization averaged at the school level and adjusted for baseline and number of students. Adjustments made by including baseline measure and number of students as covariates in models. Data will be collected at baseline and annually for 4 years.|Data will be collected at baseline and annually for 4 years.|anonymous survey data collected over 5 years and sorted by intervention. To keep ITT analysis, all schools were included and data were imputed for schools that dropped out.|||Number of events per school|Schools|95% Confidence Interval|Least Squares Mean
2628386|NCT01878097|Primary|Average Number of Sexual Assault Events Used (Perpetrated) Per School.|Students self report of sexual assault perpetration averaged at the school level and adjusted for baseline and number of students. Adjustments were made by including baseline measure and number of students as a covariate in the model. Data will be collected at baseline and annually for 4 years.|up to 5 years follow up from baseline intervention|Anonymous survey data collected over 5 years and sorted by intervention. To complete ITT analysis, schools that dropped out were included in analysis using imputed data.|||Number of events per school|Schools|95% Confidence Interval|Least Squares Mean
2628387|NCT01878084|Primary|Bone Mineral Density|The primary objective of the study is to determine the effect of using bioactive glass in inducing alveolar bone regeneration safely and effectively in surgical sockets immediately after premolar extraction assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported.|assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported.|previously described|||percentage of BMD|extraction sockets|Standard Deviation|Mean
2628388|NCT01878084|Primary|Change in Alveolar Crestal Bone Height|The primary objective of the study is to determine the effect of using bioactive glass in preservation of alveolar crestal height and width surgical sockets immediately after premolar extraction assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline ,4 and 12 weeks reported. This change was analyzed by subtracting the values of each interval from the baseline values.the positive values indicate that the alveolar crest is coronal to the cemento enaml junction (reference point) , while the negative values indicate that the alveolar crest in apical to the cemento enamel junction (reference point)|assessed at baseline, 1,2,4,8,12,24 weeks post-extraction, baseline,4 and 12 weeks reported.|previously described|||mm|extraction sockets|Standard Deviation|Mean
2628536|NCT01876823|Secondary|Change in Trails A|Change in Trails A scores from baseline to Week 48: Measures attention and executive function. It asks patients to connect numbers from 1-25 in numerical order as fast as they can. Patients are timed; the longer it takes for the patient to connect the numbers, the worse their score. Unit of measure is in seconds. The amount of errors that the patient makes during trails is also recorded.|Baseline, Week 48|Analysis was intent to treat.|||seconds||Standard Deviation|Mean
2628389|NCT01878006|Secondary|Subjective Perception of Morphine Effect - Want More|"Area under the curve of the subjective perception-time course - Want More. Subjective responses as measured by the Drug Effects Questionnaire [DEQ]. The DEQ consists of simple, face-valid, visual analog scale (VAS) questions on which people report their subjective states after ingesting a substance. The analog scale of responses ranges from not at all to extremely, and the numeric scale ranges from 0 to 100. Due to skewness of individual time points; areas under the curve for these ratings across individual time points (0, 10, 20, 30, 40, 50 and 60 min) were compared instead. Possible range of values for the AUC are 0 to 5500."|60 minutes following injection|The analyses included only those subjects who completed both PET sessions (active and placebo)|||Units on a scale * min||Standard Deviation|Mean
2628390|NCT01878006|Secondary|Subjective Perception of Morphine Effect - Like Drug|"Area under the curve of the subjective perception-time course - Like Drug. Subjective responses as measured by the Drug Effects Questionnaire [DEQ]. The DEQ consists of simple, face-valid, visual analog scale (VAS) questions on which people report their subjective states after ingesting a substance. The analog scale of responses ranges from not at all to extremely, and the numeric scale ranges from 0 to 100. Due to skewness of individual time points; areas under the curve for these ratings across individual time points (0, 10, 20, 30, 40, 50 and 60 min) were compared instead. Possible range of values for the AUC are 0 to 5500."|60 minutes following injection|The analyses included only those subjects who completed both PET sessions (active and placebo)|||Units on a scale * min||Standard Deviation|Mean
2628391|NCT01878006|Secondary|Subjective Perception of Morphine Effect - Feel High|"Area under the curve of the subjective perception-time course - Feel High. Subjective responses as measured by the Drug Effects Questionnaire [DEQ]. The DEQ consists of simple, face-valid, visual analog scale (VAS) questions on which people report their subjective states after ingesting a substance. The analog scale of responses ranges from not at all to extremely, and the numeric scale ranges from 0 to 100. Due to skewness of individual time points; areas under the curve for these ratings across individual time points (0, 10, 20, 30, 40, 50 and 60 min) were compared instead. Possible range of values for the AUC are 0 to 5500."|60 minutes following injection|The analyses included only those subjects who completed both PET sessions (active and placebo)|||Units on a scale * min||Standard Deviation|Mean
2628392|NCT01878006|Secondary|Subjective Perception of Morphine Effect - Feel Drug|"Area under the curve of the subjective perception-time course - Feel Drug. Subjective responses as measured by the Drug Effects Questionnaire [DEQ]. The DEQ consists of simple, face-valid, visual analog scale (VAS) questions on which people report their subjective states after ingesting a substance. The analog scale of responses ranges from not at all to extremely, and the numeric scale ranges from 0 to 100. Due to skewness of individual time points; areas under the curve for these ratings across individual time points (0, 10, 20, 30, 40, 50 and 60 min) were compared instead. Possible range of values for the AUC are 0 to 5500."|60 minutes following injection|The analyses included only those subjects who completed both PET sessions (active and placebo)|||Units on a scale * min||Standard Deviation|Mean
2628393|NCT01878006|Primary|11C Raclopride Binding Potential in Ventral Pallidum|Binding potential measured using regions-of-interest analysis of PET data. Parametric Binding Potential (BPND) images were obtained using the Simple Reference Tissue Model 2 (SRTM2) 33, with cerebellum as the reference region. Reduction in raclopride binding is attributed to competition with endogenous dopamine, and has been shown to be proportional to the magnitude of Dopamine (DA) release.|90 minutes following injection|The analyses included only those subjects who completed both PET sessions (active and placebo)|||mCi/ml||Standard Deviation|Mean
2628394|NCT01878006|Primary|11C Raclopride Binding Potential in Putamen|Binding potential measured using regions-of-interest analysis of PET data. Parametric Binding Potential (BPND) images were obtained using the Simple Reference Tissue Model 2 (SRTM2) 33, with cerebellum as the reference region. Reduction in raclopride binding is attributed to competition with endogenous dopamine, and has been shown to be proportional to the magnitude of Dopamine (DA) release.|90 minutes following injection|The analyses included only those subjects who completed both PET sessions (active and placebo)|||mCi/ml||Standard Deviation|Mean
2628395|NCT01878006|Primary|11C Raclopride Binding Potential in Nucleus Accumbens|Binding potential measured using regions-of-interest analysis of PET data. Parametric Binding Potential (BPND) images were obtained using the Simple Reference Tissue Model 2 (SRTM2) 33, with cerebellum as the reference region. Reduction in raclopride binding is attributed to competition with endogenous dopamine, and has been shown to be proportional to the magnitude of Dopamine (DA) release.|90 minutes following injection|The analyses included only those subjects who completed both PET sessions (active and placebo)|||mCi/ml||Standard Deviation|Mean
2628396|NCT01878006|Primary|11C Raclopride Binding Potential in Caudate|Binding potential measured using regions-of-interest analysis of PET data. Parametric Binding Potential (BPND) images were obtained using the Simple Reference Tissue Model 2 (SRTM2) 33, with cerebellum as the reference region. Reduction in raclopride binding is attributed to competition with endogenous dopamine, and has been shown to be proportional to the magnitude of Dopamine (DA) release.|90 minutes following injection|The analyses included only those subjects who completed both PET sessions (active and placebo)|||mCi/ml||Standard Deviation|Mean
2628397|NCT01877941|Primary|Cardiac Output as Measured by ECOM|Measurements of cardiac output derived from the Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.|During and post-surgery, up to 8 hours|Supplies for the ECOM device were not available so it was not tested.||||||
2628398|NCT01877941|Primary|PAC (Pulmonary Artery Catheter).|"Measurements of cardiac output derived from a PAC (pulmonary artery catheter) using the standard thermodilution technique. At each time point, at least 6 measurements were taken. If, in the opinion of the clinician taking the readings, some of these were in error, more readings were taken to ensure accuracy. In no case were more than 18 readings taken. The points deemed valid by the clinician were averaged to obtain the reference value for that time point. The mean and standard deviation reported consisted of the reference values from all time points measured.~Data for this test were taken at the following timepoints:~1. Start of Sterenotomy; 2. Before Bypass; 3. 30 Min after bypass; 4. Closure; 5. ICU arrival; 6. 6 hours in ICU; 7. 12 Hours in ICU; 8. 18 Hours in ICU (if PAC still in); 9. 24 Hours in ICU (If PAC still in)"|During and post-surgery, up to 24 hours||||liters/minute||Standard Deviation|Mean
2635872|NCT01798225|Primary|Glycated Hemoglobin A1c|Glycated Hemoglobin A1c|Change between baseline to 6-month post-treatment||||percentage of Glycated Hemoglobin A1c||Full Range|Mean
2628399|NCT01877941|Primary|esCCO (Estimated Continuous Cardiac Output) Monitor|"6 Measurements of cardiac output derived from pulse oximeter measurements using the esCCO system were taken at each time point. The measurements deemed valid under the criteria in the protocol were averaged to represent the reference value at that point. The mean and standard deviation reported consist of the reference values from all time points measured.~Data for this test were taken at the following timepoints:~1. Start of Sterenotomy; 2. Before Bypass; 3. 30 Min after bypass; 4. Closure; 5. ICU arrival; 6. 6 hours in ICU; 7. 12 Hours in ICU; 8. 18 Hours in ICU (if PAC still in); 9. 24 Hours in ICU (If PAC still in)"|During and after surgery, up to 24 hours||||liters/minute||Standard Deviation|Mean
2628400|NCT01877915|Secondary|Event Rate of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding Event|Event rate of ISTH major bleeding event were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.|Up to 227 Weeks|Safety Analysis Set included all intent-to-treat participants who received at least one dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure.|||Event rate per 100 patient-year|||Number
2628401|NCT01877915|Secondary|Event Rate of Bleeding Events That Requiring Hospitalization|Event rate of bleeding events and required Hospitalization were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.|Up to 227 Weeks|Safety Analysis Set included all intent-to-treat participants who received at least one dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure.|||Event rate per 100 patient-year|||Number
2628402|NCT01877915|Primary|Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability|Event rate of either fatal bleeding or bleeding into critical space with potential for permanent disability were assessed. Fatal bleeding event was death within 7 days after a bleeding event which required hospitalization or met International Society on Thrombosis and Haemostasis(ISTH) major bleeding definition criteria. Fatal bleeding events included those met criteria in 3 categories: 1: Any ISTH major bleeding event consider primary cause of death by investigator; 2: Any ISTH major bleeding event not considered to be primary cause of death by investigator but resulted in death within 7 days;3: Any bleeding event resulted in hospital stay and death within 7 days. Bleeding into critical space with potential for permanent disability included 7 critical spaces: intracranial, intraspinal, intraocular. Event rate estimated based on time to first occurrence of event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.|Up to 227 Weeks|Safety Analysis Set included all intent-to-treat participants who received at least one dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure.|||Event rate per 100 patient-year|||Number
2628403|NCT01877915|Secondary|Event Rate of All-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure|Event rate of all-Cause Mortality (ACM) or re-Hospitalization for worsening heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.|Up to Global treatment end date (approximately 54 months)|Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received.|||Event rate per 100 patient-year|||Number
2628404|NCT01877915|Secondary|Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV)|Event rate due to cardio vascular events were assessed. Hospitalization for a CV Event required that participants be hospitalized (in-patient or emergency department) for greater than 24 hours and must have met the following criterion:Discharge summary with primary reason for admission listed as CV in nature (example, bleeding, arrhythmia, ACS, MI) other than HF which was captured in the HF re-hospitalization. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.|Up to Global treatment end date (approximately 54 months)|Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received.|||Event rate per 100 patient-year|||Number
2628405|NCT01877915|Secondary|Event Rate of Re-Hospitalization for Worsening of Heart Failure|Event rate of re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.|Up to Global treatment end date (approximately 54 months)|Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received.|||Event rate per 100 patient-year|||Number
2628406|NCT01877915|Secondary|Event Rate of Cardio Vascular Death|Event rate of cardio vascular death were assessed. CV death included deaths due to spontaneous bleeding, MI, stroke, worsening HF and arrhythmias, death due to CV procedures and sudden death. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.|Up to Global treatment end date (approximately 54 months)|Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received.|||Event rate per 100 patient-year|||Number
2628407|NCT01877915|Secondary|Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF)|Event rate of cardio vascular (CV) death or re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events.|Up to Global treatment end date (approximately 54 months)|Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received.|||Event rate per 100 patient-year|||Number
2628695|NCT01875237|Secondary|To Assess Post Donor Lymphocyte Infusion (DLI) Chimerism|To assess the number of Participants with 100% donor chimerism at 6 months post donor lymphocyte infusion (DLI)|6 months|patients who received DLI|||Participants|||Count of Participants
2628408|NCT01877915|Primary|Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke|Event Rate of all-cause mortality (ACM), MI, or stroke were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 patient [pt]-year [yr]) = 100*n/(total risk exposure), where n is the number of events.|Up to Global treatment end date (approximately 54 months)|Intent-to-Treat analysis set included all randomized unique participants who signed a valid informed consent. Participants were analyzed according to the treatment group assigned, irrespective of the actual treatment received.|||Event rate per 100 patient-year|||Number
2628409|NCT01877720|Secondary|Respiratory Rate||last 5-min of each 15-min trial|||||||
2628410|NCT01877720|Secondary|Blood Pressure|systolic, diastolic and mean blood pressure measured by non-invasive cuff|last 5-min of each 15-min trial|||||||
2628411|NCT01877720|Secondary|Heart Rate||last 5-min of each 15-min trial|||||||
2628412|NCT01877720|Secondary|SpO2|transcutaneous peripheral saturation of oxygen by pulse oximeter|last 5-min of each 15-min trial|||||||
2628413|NCT01877720|Secondary|Asynchrony Index|"total number of each event per minute~ineffective efforts: presence of a characteristic EAdi (electrical activity of diaphragm) activity not followed by a ventilator delivered pressurization~auto-triggering: a cycle delivered by the ventilator without EAdi signal~premature cycling~delayed cycling: VPT > NIT x2~double triggering~Asynchrony index = [(1)+(2)+(3)+(4)+(5)]/[(1)+pneumatic respiratory rate] x100"|last 5-min of each 15-min trial||||percentage of neural respiration||Inter-Quartile Range|Median
2628414|NCT01877720|Secondary|All Asynchrony Events||last 5-min of each 15-min trial||||events per min||Inter-Quartile Range|Median
2628415|NCT01877720|Secondary|Leakage|[TVi (inspiratory tidal volume) - TVe (expiratory tidal volume)]/TVi (inspiratory tidal volume)|last 5-min of each 15-min trial||||percentage of inspiratory tidal volume||Standard Deviation|Mean
2628416|NCT01877720|Secondary|Swing EAdi||last 5-min of each 15-min trial||||uV||Standard Deviation|Mean
2628417|NCT01877720|Secondary|Maximum EAdi||last 5-min of each 15-min trial||||uV||Standard Deviation|Mean
2628418|NCT01877720|Secondary|Pneumatic Respiratory Rate||last 5-min of each 15-min trial||||breaths per min||Standard Deviation|Mean
2628419|NCT01877720|Secondary|Peak Inspiratory Pressure||last 5-min of each 15-min trial||||cmH2O||Standard Deviation|Mean
2628420|NCT01877720|Secondary|Minute Ventilation Volume|inspiratory tidal volume / respiratory rate|last 5-min of each 15-min trial||||mL/kg/min||Standard Deviation|Mean
2628421|NCT01877720|Secondary|Ti_excess (Inspiratory Time in Excess)|"Ti_excess = (VPT-NIT)/NIT~VPT: ventilator pressurization time (VPT) between beginning and end of inspiratory flow NIT: neural inspiratory time (NIT) between beginning of the increase in the diaphragmatic excitation and its maximal value"|last 5-min of each 15-min trial||||percentage of neural inspiratory time||Standard Deviation|Mean
2628422|NCT01877720|Primary|Trigger Delay|Inspiratory trigger delay could be calculated by the time interval between beginning of the increase of actual diaphragmatic excitation and start of ventilator inspiratory flow of each respiration. The value will be present as a mean of all inspiratory trigger delay measurements of all respiration during last 5 minutes of each 15 minutes trial.|last 5-min of each 15-min trial||||ms||Standard Deviation|Mean
2628423|NCT01877668|Secondary|Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI)|BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a visual analog scale of 0-100mm (0=none and 100=very severe) participants answer 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averages the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug with presence of spondylitis at screening and baseline BASDAI score>0 cm and were evaluable. n=number of participants evaluable at each visit.|||cm||Standard Error|Least Squares Mean
2628424|NCT01877668|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score|"FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (washed out), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue impact on daily functioning."|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628425|NCT01877668|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score|"FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (washed out), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue experience."|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628459|NCT01877668|Secondary|Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12|Assessment of joint damage includes a joint erosion score (range 0-320) and a JSN score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing. Progressor is defined as an increase in mTSS >0.5 from baseline.|At Month 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Percentage of participants|||Number
2628426|NCT01877668|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score|"FACIT-F is a 13-item questionnaire, with each item scored on a 5-point scale ranging from 0 (not at all) to 4 (very much). Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0 to 52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless (washed out), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better fatigue status."|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628427|NCT01877668|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher scores indicate a better health state, with a higher value representing better health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||mm||Standard Error|Least Squares Mean
2628428|NCT01877668|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628429|NCT01877668|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit|||Units on a scale||Standard Error|Least Squares Mean
2628430|NCT01877668|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628431|NCT01877668|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-care|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628439|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represents better role-physical functioning.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628432|NCT01877668|Secondary|Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility|The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems [1], some or moderate problems [2], or extreme problems [3]) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm visual analogue scale (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628433|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher mental health domain score represents better mental health functioning.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628434|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-emotional domain score represents better role-emotional functioning.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628435|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher social functioning domain score represents better social functioning.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number pf participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628436|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher vitality domain score represents better vitality.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628437|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher general health domain score represents better general health perceptions.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628438|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represents less bodily pain.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628457|NCT01877668|Secondary|Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12|"ACR70 was calculated as a ≥70% improvement from baseline in tender/painful and swollen joint counts and ≥70% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.~."|At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12|All participants who were randomized and received at least 1 dose of study drug. n=number of responders.|||Percentage of participants|||Number
2628440|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represents better physical functioning.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628441|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628442|NCT01877668|Secondary|Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score|The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represents better physical health status.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628443|NCT01877668|Secondary|Change From Baseline in the Leeds Enthesitis Index (LEI)|Enthesitis is inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assesses enthesitis in 6 sites. Tenderness is recorded as either present (1) or absent (0) for each of the 6 sites, for an total score of 0-6. Higher score indicates a greater number of sites that are affected by enthesitis.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug with baseline LEI>0 and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628444|NCT01877668|Secondary|Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index|The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. On examination, tenderness is recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicates a greater number of sites that are affected by enthesitis.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug with baseline SPARCC Enthesitis Score>0 and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628445|NCT01877668|Secondary|Change From Baseline in Dactylitis Severity Score (DSS)|Dactylitis is characterized by swelling of the entire finger or toe. The DSS is a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis is scored on a scale of 0-3, where 0=no tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a patient is 0-60. Higher score indicates greater degree of tenderness.|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug with baseline DSS>0 and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628446|NCT01877668|Secondary|Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12|PASI determines psoriasis severity based on lesion severity & percentage body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, & scaling, evaluated separately for head & neck, upper limbs, trunk, & lower limbs & rated for each body area according to a 5 point scale: 0=no involvement; 1=slight; 2=moderate; 3=marked; 4=very marked. BSA involvement is the extent (%) of body area affected by psoriasis & is assigned a score: 0=no involvement; 1=0-9%; 2=10-29%; 3=30-49%; 4=50-69%; 5=70-89%; 6=90-100%. In each area, sum of severity rating scores is multiplied by the score representing the percentage of area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of numbers obtained for the 4 body areas is the PASI score & can vary in increments of 0.1 & range from 0.0 to 72.0, higher scores represent greater severity of psoriasis. PASI75 is defined as a 75% reduction from baseline in PASI.|At Months 1, 3, 6, 9, and 12|All participants who were randomized and received at least 1 dose of study drug with PASI>0 and BSA ≥3% at baseline. n=number of responders.|||Percentage of participants|||Number
2628458|NCT01877668|Secondary|Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12|ACR50 was calculated as a ≥50% improvement from baseline in tender/painful and swollen joint counts and ≥50% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.|At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12|All participants who were randomized and received at least 1 dose of study drug. n=number of responders.|||Percentage of participants|||Number
2650845|NCT01665170|Secondary|Serum Cortisol (Pre-post Comparison)|2 min. prior to and 1 min. after the TSST|1 day|||||||
2628447|NCT01877668|Secondary|Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response|The PGA-PsO is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are rated separately over the whole body according to a 5-point severity scale, scored as 0=none; 1, 2, 3, or 4=most severe. The severity rating scores are summed and the average taken; the total average is rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).|From Baseline to Months 1, 3, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug with baseline PGA-PsO>0 and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628448|NCT01877668|Secondary|Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12|The PsARC covers 4 measures: Tender/painful joint count, swollen joint count, the Physician's Global Assessment of Arthritis, and the Patient's Global Assessment of Arthritis. The PsARC response is defined as improvement in 2 of 4 items, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement criteria: ≥20% improvement in Physician's Global Assessment of Arthritis; ≥20% improvement in Patient's Global Assessment of Arthritis; ≥30% improvement in tender joint count; and ≥30% improvement in swollen joint count.|At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12|All participants who were randomized and received at least 1 dose of study drug. n=number of responders.|||Percentage of participants|||Number
2628449|NCT01877668|Secondary|Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count|Tender/painful joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty eight (68) joints were assessed by a blinded assessor to determine the number of joints that were considered tender or painful.|From Baseline to end of Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Joints||Standard Error|Least Squares Mean
2628450|NCT01877668|Secondary|Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count|Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling.|From Baseline to end of Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Joints||Standard Error|Least Squares Mean
2628451|NCT01877668|Secondary|Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis|The blinded investigator or qualified assessor assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).|From Baseline to end of Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||mm||Standard Error|Least Squares Mean
2628452|NCT01877668|Secondary|Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis|"Participant answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The participant's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very well) and 100 (very poorly)."|From Baseline to end of Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||mm||Standard Error|Least Squares Mean
2628453|NCT01877668|Secondary|Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain|Participants assessed the severity of their arthritis pain using a 100-mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|From Baseline to end of Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||mm||Standard Error|Least Squares Mean
2628454|NCT01877668|Secondary|Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|From Baseline to end of Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||mg/L||Standard Error|Least Squares Mean
2628455|NCT01877668|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.|From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable. n=number of participants evaluable at each visit.|||Units on a scale||Standard Error|Least Squares Mean
2628456|NCT01877668|Secondary|Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12|ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP.|At Week 2 and Months 1, 2, 4, 6, 9, and 12|All participants who were randomized and received at least 1 dose of study drug. n=number of responders.|||Percentage of participants|||Number
2628471|NCT01877642|Secondary|Relative Pharmacodynamic Effect on Heart Rate for Combined vs Individual (Lorazepam, Loxapine)|LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for heart rate following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone|24 hours|Pharmacodynamic population|||percentage of effect on control drug||90% Confidence Interval|Geometric Least Squares Mean
2628460|NCT01877668|Secondary|Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis|Assessment of joint damage includes a joint erosion score (range 0-320) and a joint space narrowing (JSN) score (range 0-208). The mTSS is the sum of the erosion and JSN scores (range 0-528). A higher score indicates more severe disease status. If a component score is missing, the mTSS will be missing.|From Baseline to Month 12|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
2628461|NCT01877668|Primary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.|From Baseline to Month 3|All participants who were randomized, received at least 1 dose of study drug and were evaluable.|||Units on a scale||Standard Error|Least Squares Mean
2628462|NCT01877668|Primary|Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3|ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire - disability index (HAQ-DI), and C-reactive protein (CRP).|At end of Month 3|All participants who were randomized and received at least 1 dose of study drug.|||Percentage or participants|||Number
2628463|NCT01877655|Secondary|All-Cause Mortality at 1 Year Posttransplant|All-cause mortality through 1-year post-transplantation summary included all deaths and unknown survival status. For the known deaths, the adjudication committee assessed results and summarized them according to the following category: Mortality due to the participant's primary disease, and mortality due to causes unrelated to the participant's primary disease. Participants with unknown survival status at 1 year were considered dead for this analysis.|From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)|The analysis population was the FAS.|||Percentage of Participants|||Number
2628464|NCT01877655|Secondary|Percentage of Participants With First Occurrence of Adjudicated CMV-specific AVT or Adjudicated Diagnosis of CMV EOD After Study Drug First Injection Through 1 Year Posttransplant|Rate was based on cumulative incidence function estimate at 1 year. Time to first CMV-specific AVT was defined as time to the start of AVT for CMV viremia or CMV EOD. CMV-specific AVT and EOD were determined by the adjudication committee. This endpoint was a composite endpoint based on the independent adjudication committee assessments of CMV-specific AVT and CMV EOD.|From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)|The analysis population was the FAS.|||Percentage of Participants||95% Confidence Interval|Number
2628465|NCT01877655|Secondary|Percentage of Participants With a Composite Endpoint of Protocol-defined CMV Viremia and Adjudicated CMV-Specific AVT Use|Protocol-defined CMV viremia was as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory. The CMV-specific AVT was determined by the adjudication committee. Participants with no posttransplant viral load data were excluded from the analysis.|From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)|The analysis population was the FAS.|||Percentage of Participants|||Number
2628466|NCT01877655|Secondary|Percentage of Participants With Adjudicated CMV-Specific Antiviral Therapy (AVT) Through 1 Year Posttransplant|The CMV-specific AVT use was adjudicated by the independent and blinded committee. When the CMV-specific AVT was initiated, a central CMV viral load was obtained weekly until it was discontinued. Participants without any CMV-specific AVT events were censored on the last study evaluation.|From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)|The analysis population was the FAS.|||Percentage of Participants||95% Confidence Interval|Number
2628467|NCT01877655|Secondary|Percentage of Participants With Protocol-Defined CMV Viremia Through 1 Year Posttransplant|Protocol-defined CMV viremia was defined as a CMV plasma viral load ≥1000 IU/mL as assessed by the central laboratory. Rate was based on cumulative incidence function estimated at 1 year. The central laboratory had the lower limit of quantification [LLOQ] for CMV viral load assessment, so when the viral load was below the LLOQ the actual viral load reading was not possible and was denoted as ≤LLOQ. If participant had any CMV viral load assessments greater than the LLOQ it was classified as viremic.|From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)|The analysis population was the FAS.|||Percentage of Participants||95% Confidence Interval|Number
2628468|NCT01877655|Primary|Percentage of Participants With Composite of All-Cause Mortality and Adjudicated Cytomegalovirus End Organ Disease (CMV EOD) Through 1 Year Post Transplant|This was the composite of all-cause mortality and adjudicated CMV EOD through 1 year posttransplant, The CMV EOD was assessed by the independent and blinded adjudication committee, which counted events that were observed up to day 380 from transplantation. Deaths that occurred up to day 365 from transplant were also counted.|From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)|The analysis population was the full analysis set (FAS), which consisted of all randomized participants who received at least one dose of randomized study drug.|||Percentage of Participants|||Number
2628469|NCT01877642|Secondary|Relative Pharmacodynamic Effect on Cogscreen Pathfinder Response for Combined vs Individual (Lorazepam, Loxapine)|LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for Cogscreen Pathfinder Response following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone|24 hours|Pharmacodynamic population|||percentage of effect on control drug||90% Confidence Interval|Geometric Least Squares Mean
2628470|NCT01877642|Secondary|Relative Pharmacodynamic Effect on Diastolic Blood Pressure for Combined vs Individual (Lorazepam, Loxapine)|LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for diastolic blood pressure following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone|24 hours|Pharmacodynamic population|||percentage of effect on control drug||90% Confidence Interval|Geometric Least Squares Mean
2628473|NCT01877642|Secondary|Relative Pharmacodynamic Effect on Sedation for Combined vs Individual (Lorazepam, Loxapine)|LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for sedation based on a 100 mm Visual Analog Scale (VAS) ranging from (0=sleepy to 100=wide awake) following administration of Lorazepam+Loxapine compared to the same measure following each control drug given alone (Lorazepam, Loxapine)|24 hours|Pharmacodynamics Population|||percentage of effect on control drug||90% Confidence Interval|Geometric Least Squares Mean
2628474|NCT01877642|Secondary|Relative Pharmacodynamic Effect on Systolic Blood Pressure for Combined vs Individual (Lorazepam, Loxapine)|LS Means ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for systolic blood pressure following administration of Lorazepam+Loxapine compared to the same measure following each control drug (Lorazepam, Loxapine) given alone|24 hours|Pharmacodynamics Population|||percentage of effect on control drug||90% Confidence Interval|Geometric Least Squares Mean
2628475|NCT01877642|Primary|Relative Pharmacodynamic Effect on Respiration Rate for Combined vs Individual (Lorazepam, Loxapine)|LS Mean ratio (90% CI) of the area under the curve for 0 to 24 hours (AUC 0-24) for respiration rate following administration of Lorazepam+Loxapine compared to the same measure following each control drug given alone (Lorazepam, Loxapine)|24 hours|Pharmacodynamics Population|||percentage of effect on control drug||90% Confidence Interval|Geometric Least Squares Mean
2628476|NCT01877642|Primary|Maximum Level of Sedation for Lorazepam 1 mg IM + ADASUVE 10 mg|Determine the maximum level of sedation for Lorazepam 1 mg IM + ADASUVE 10 mg based on the 100 mm Visual Analog Scale (VAS) ranging from (0=sleepy to 100=wide awake)|24 hours|Open label population|||units on a scale||Standard Deviation|Mean
2628477|NCT01877564|Primary|IHC-based Tissue Markers of Proliferation||1 year|data were not collected||||||
2628478|NCT01877551|Secondary|Liver Function Tests|We will measure liver function tests before and after the study drug to ensure that no abnormalities in liver function occurs with the drug.|Pre-Treatment and Post 30 day-Treatment||||ALT (IU/ml)||Standard Error|Mean
2628479|NCT01877551|Secondary|Liver Fat|We will use MRI to measure the relative (%) amount of fat in each subject's liver before and after 30 days of treatment. This will allow us to determine if the drug reduces liver fat. This is calculated by subtracting the amount of fat in the liver at the beginning of the study from the amount of fat in the liver after 30 days of treatment. Subjects who have claustrophobia or are unable to undergo MRI will not have this measure performed. Due to these reasons liver MRS was only performed in 10 patients in the tauroursodeoxycholic acid group and 9 subjects in the placebo group|Pre-Treatment and Post 30 day-Treatment||||Change in Percent liver fat||Standard Error|Mean
2628480|NCT01877551|Secondary|Body Composition|We will measure how much fat is present in each subject before and after treatment with TUDCA or placebo.|Pre-Treatment and Post 30 day-Treatment||||percentage of body fat||Standard Error|Mean
2628481|NCT01877551|Primary|Glucose Uptake|We will examine the ability of insulin to cause muscle to take up insulin. Each subject will receive intravenous insulin for 6 hours to see how much sugar needs to be given intravenously to keep the blood sugar normal, a measure called glucose uptake. We will compare glucose uptake measured as the amount of 20% dextrose that is needed to keep the blood sugar at ~100mg/dl during insulin infusion before and after 30 days of treatment with drug or placebo.|Glucose uptake is measured at baseline and 30 days after study intervention||||change in glucose infusion rate (ml/hr)||Standard Error|Mean
2628482|NCT01877538|Primary|Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE|"SUV values were calculated in 7 internal organs. SUV is a unitless ratio. We normalised to injected dose and bodyweight.~SUV (organ) = activity concentration (organ; kBq/mL) * bodyweight (mL) / injected dose (kBq)~Note: it is a common assumption when calculating SUV values that bodyweight equals volume, and therefore the unit mL is appropriate."|1 day (one timepoint)|In 6 subjects the SUV values in internal organs were calculated.|||Unitless ratio||Standard Deviation|Mean
2628483|NCT01877538|Primary|Distribution Volume (DV) of [11C]Donepezil - BASELINE|Logan's graphical analysis is used to calculate Distribution Volumes in Volumes of interest in internal organs (salivary gland, heart, liver, stomach, intestines, kidneys). Arterial blood sampling with radio metabolite correction is performed.|1 day (One timepoint)|In 6 subjects we analysed Volumes of distribution (Vd) and SUV values in internal organs (parotid, submandibular, spleen, stomach, heart, intestine, pancreas). NOTE: In subject number 7 we examined radioactive dose in 23 target organs (dose: microSv/MBq) and calculated the combined effective dose. The Vd and SUV values listed are from 6 subjects.|||mL||Standard Deviation|Mean
2628484|NCT01877421|Secondary|Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a|"Proof of concept of KSL-W in reducing plaque as measured by percent of bleeding sites upon probing (BOP) in phase 2a.~Gingivitis will be assessed using both the MGI (Modified Gingival Index) and the Gingival Bleeding Index (BOP). The Modified Gingival Index assesses the buccal and lingual gingivae and interdental papillae. The Gingival Bleeding Index assesses the percentage of sites that bleed on gentle probing. A periodontal probe (HU-Friedy UNC 15) will be gently inserted into the gingival sulcus until resistance is felt at mid-facial (buccal), mid-lingual, mesial, and distal interproximal sites of all scorable teeth, with the exception of the most posterior distal sites. Presence or absence of bleeding will be recorded for each site and the percentage of bleeding sites per subject will serve as the unit of analysis."|days 0, 14, 28, 34||||Percent of bleeding sites||Standard Deviation|Mean
2628485|NCT01877421|Secondary|Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a|"Data summarizes gingival index scores changes from baseline in phase 2a. Gingivitis will be assessed using both the MGI (Modified Gingival Index) and the Gingival Bleeding Index (BOP) The Modified Gingival Index assesses the buccal and lingual gingivae and interdental papillae.~Modified Gingival Index Scores:~0 Absence of inflammation~Mild inflammation; slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit~Mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit~Moderate inflammation; glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit~Severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration."|days 14, 28, 34||||scores on a scale||Standard Deviation|Mean
2628551|NCT01876784|Secondary|Evaluation of the Safety and Tolerability of Vandetanib Treatment in the Patient Population by Assessment of Adverse Events, Vital Signs, Laboratory Parameters and Electrocardiography.|Once 155 progression events have occurred.|Safety assessments at baseline, Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter|||||||
2628486|NCT01877421|Secondary|Proof of Concept of KSL-W in Reducing Plaque in Phase 2a|"Data summarizes plaque index scores changes from baseline. Supragingival plaque will be assessed after the MGI and BOP assessments and following use of a disclosing solution on the facial (buccal) and lingual surfaces of a minimum of 16 scorable teeth according to the criteria of the Turesky modification of the Quigley-Hein Plaque Index.~Quigley-Hein Plaque Index Scores with Turesky Modifications:~0 No plaque~Separate flecks of plaque at the cervical margin of the tooth~A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth~A band of plaque wider than one mm but covering less than one-third of the crown of the tooth~Plaque covering at least one-third but less than two thirds of the crown of the tooth~Plaque covering two-thirds or more of the crown of the tooth"|days 14, 28, 34||||scores on a scale||Standard Deviation|Mean
2628487|NCT01877421|Primary|Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs)|Occurrence of local oral mucosal reactions, systemic reactions such as fever, nausea, headache, and changes in blood pressure, clinical laboratory measures of safety, and serious total body reactions will be assessed (AEs and SAEs)|Up to 28 days||||Participants|||Count of Participants
2628488|NCT01877408|Other Pre-specified|Number of Participants With Adverse Events|Number of participants with intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection|1 year||||participants|||Number
2628489|NCT01877408|Secondary|Cosmetic Result|Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance)|Within 6 weeks after surgery||||participants|||Number
2628490|NCT01877408|Secondary|Overall Patient Satisfaction|"Patient satisfaction evaluated with questionnaire using satisfaction scale~Very satisfied~Satisfied~Not satisfied"|Within 6 weeks after surgery||||participants|||Number
2628491|NCT01877408|Secondary|Pain Experienced|Pain experienced during and after the procedure evaluated using a 10 point pain scale (0 signifies no pain and 10 signifies maximal pain|Within 2 days after surgery||||units on a 10-point pain scale||Standard Deviation|Mean
2628492|NCT01877408|Secondary|Number of Participants With Complete Wound Healing by Post-Surgery Week 4||Within 4 weeks after surgery||||participants|||Number
2628493|NCT01877408|Secondary|Difficulty in Learning and Performing Technique|"Evaluated by doctor survey based on 5 point Likert scale~Unicirc is much easier~Unicirc is easier~Neutral~Open surgical is easier~Open surgical is much easier"|1 year|The four physicians that participated in this study performed both procedures (i.e. open surgical and Unicirc) on study participants. Three physicians had significant previous (non-study) experience performing open surgical circumcisions. All four had no to very limited previous experience performing Unicirc circumcisions.|||units on Likert scale||Full Range|Median
2628494|NCT01877408|Primary|Intraoperative Duration|Amount of time from first manipulation of tissue under local anesthesia to dressing|1 hour||||minutes||Inter-Quartile Range|Median
2628495|NCT01877343|Primary|Pulse Strength|Continuous change of pulse strength from baseline through the end of the study. Pulse strength is measured as volts by the system. Changes in pulse strength will be plotted against the four tilt table positions. Four positions will be explored, Mounting position, baseline, passive leg raise (cardiac preload dependent) and orthostasis head raise (cardiac afterload dependent). Patients go from mounting position, to baseline, to the corresponding position (passive leg raise or orthostasis head raise) and back to baseline. The assessment will take 30 minutes. Cardiac function curves will be constructed with the data collected and average pulse strength from baseline to 30 minutes will be reported.|Average pulse strength from baseline to 30 minutes|The study was terminated and the data was not sent to the contract company to analyze. The software package to compile the data is not available to the University of Florida.||||||
2628496|NCT01877343|Primary|Pulse Rate|Continuous change of pulse rate from baseline through the end of the study will be followed. Changes in pulse rate will be plotted against the four tilt table positions. Four positions will be explored, Mounting position, baseline, passive leg raise (cardiac preload dependent) and orthostasis head raise (cardiac afterload dependent). Patients go from mounting position, to baseline, to the corresponding position (passive leg raise or orthostasis head raise) and back to baseline. The assessment will take 30 minutes. From the graph, average pulse rate is calculated.|Average pulse rate from baseline to 30 minutes|The study was terminated and the data was not sent to the contract company to analyze. The software package to compile the data is not available to the University of Florida.||||||
2628497|NCT01877278|Primary|Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4|"Multi-item questionnaire used to assess pain, stiffness, and physical function in patients with knee osteoarthritis.~The WOMAC consists of 24 items divided into 3 subscales:~Pain (5 items), Stiffness (2 items) and Physical Function (17 items). Score Range: On the Likert Scale version, the scores are summed for items in each subscale, with possible ranges as follows: pain=0-50, stiffness=0-20, physical function=0-170. A total WOMAC score is created by summing the items for all three subscales. A higher score represents a worse outcome."|baseline and 4 weeks||||units on a scale||Standard Deviation|Mean
2628498|NCT01877278|Primary|Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4|visual analogue scale (VAS) is a validated self report instrument assessing self report pain intensity Possible scores ranges:from 0 (no pain) to 100 (the maximum of pain)|baseline and 4 weeks||||units on a scale||Standard Deviation|Mean
2628499|NCT01877265|Secondary|Glucodynamics: Total Amount of Glucose Infused (Gtot)|The total amount of glucose infused following LY2605541 injection is summarized for each PEG source (LY1, LY2, or LY3).|Predose and up to 24 hours post dose in each period|Participants who received at least 1 dose of LY2605541 and had evaluable glucose infusion data.|||milligrams per kilogram||Geometric Coefficient of Variation|Geometric Mean
2628500|NCT01877265|Secondary|Glucodynamics: Maximum Glucose Infusion Rate (Rmax)|The maximum observed glucose infusion rate following LY2605541 injection is summarized for each PEG source (LY1, LY2, or LY3).|Predose and up to 24 hours post dose in each period|Participants who received at least 1 dose of LY2605541 and had evaluable glucose infusion data.|||milligrams per minute per kilogram||Geometric Coefficient of Variation|Geometric Mean
2628552|NCT01876784|Secondary|Demonstration of an Improvement in Time to Worsening of Pain in Patients Treated With Vandetanib When Compared to Placebo in the Patient Population.|Once 155 progression events have occurred.|Patient assessments at baseline, week 4, 8, 12 and then every 12 weeks thereafter, assess up to 25.5 months|||||||
2628502|NCT01877265|Primary|Pharmacokinetics: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541|LY2605541 exposure in terms of AUC from time 0 extrapolated to infinity (AUC[0-inf]) is summarized for each PEG source (LY1, LY2, or LY3).|Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post dose in each period|Participants who received at least 1 dose of LY2605541 and had evaluable LY2605541 concentration data.|||picomoles times hours per liter||Geometric Coefficient of Variation|Geometric Mean
2628503|NCT01877239|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Scores at Week 12, Week 24 and Week 52|CDAI is a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC, TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, > 2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Baseline, Week 12, Week 24, Week 52|"FAS included any participants who had given written informed consent. Here, number analyzed signifies participants who were evaluable at specified categories."|||units on a scale||Standard Deviation|Mean
2628504|NCT01877239|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52|CDAI is a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC, TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, > 2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity. Percentage of participants with different type of CDAI status of disease activity (remission, low disease, moderate and high disease activity) at Week 12 and 52 were reported. Only those categories in which at least 1 participant had data were reported.|Week 12 and Week 52|FAS included any participants who had given written informed consent.|||percentage of participants|||Number
2628505|NCT01877239|Primary|Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24|CDAI is a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI less than equal to (<=) 2.8 indicates disease remission, greater than (>) 2.8 to 10 = low disease activity, greater than (>) 10 to 22 = moderate disease activity, and >22 = high disease activity. Percentage of participants with CDAI remission (score <=2.8) at Week 24 were reported.|Week 24|Eligible Set included all participants who had given written informed consent and had received at least one dose of etanercept with evaluable CDAI assessments at baseline and Week 24.|||percentage of participants||95% Confidence Interval|Number
2628506|NCT01877187|Secondary|6-month Survival Rate of Patients With HCC and Liver Metastases Treated With Conventional TACE|Measure the association between baseline Lipiodol deposition and the 6-month survival rate by estimating median survival for each stratum, and by testing for homogeneity using a logrank test if hazards are proportional.|6 months|Kaplan-Meier survival analysis to estimate survival rate% at 6 months. Subjects are censored if survival is unknown at time point due to loss to followup.|||percentage of partcipants|||Number
2628507|NCT01877187|Secondary|Baseline Enhancing Tumor and Response by qEASL Criteria|Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by qEASL criteria. Responders are subjects that demonstrated Complete Response or Partial Response by qEASL criteria. Nonresponders are all other subjects.|30 days, 90 days, 180 days|16 HCC and 14 non-HCC subjects had applicable data for analysis at 30day f/u, 9 HCC and 6 non-HCC at 90 day f/u, and 9 HCC and 4 non-HCC at 180 day f/u.|||% tumor enhancement||Full Range|Median
2628508|NCT01877187|Secondary|Tumor Response by Quantitative European Association for the Study of the Liver (qEASL) Criteria|"Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with qEASL response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per qEASL criteria:~Complete Response (CR): Total disappearance of enhancing tumor volume in target lesions Partial Response (PR): At least 65% decrease in enhanced tumor volume after treatment.~Overall Response: CR + PR"|6 months|16 HCC and 14 non-HCC subjects had complete data for qEASL analysis at 30day f/u, 9 HCC and 7 non-HCC at 90 day f/u, and 9 HCC and 5 non-HCC at 180 day f/u.|||Participants|||Count of Participants
2628509|NCT01877187|Secondary|Baseline Enhancing Tumor and Response by EASL Criteria|Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by EASL criteria. Responders are subjects that demonstrated Complete Response or Partial Response by EASL criteria. Nonresponders are all other subjects.|30 days, 90 days, 180 days|16 HCC and 14 non-HCC subjects had applicable data for analysis at 30day f/u, 9 HCC and 6 non-HCC at 90 day f/u, and 9 HCC and 4 non-HCC at 180 day f/u.|||% tumor enhancement||Full Range|Median
2628510|NCT01877187|Secondary|Tumor Response by European Association for the Study of the Liver (EASL) Criteria|"Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with EASL response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per EASL response:~Complete Response (CR): complete disappearance of enhancing tissue in target lesions Partial Response (PR): At least 50% decrease in area of enhancing tissue in target lesions.~Overall Response: CR+PR"|6 months|18 HCC and 14 non-HCC subjects had complete data for analysis at 30day f/u, 11 HCC and 7 non-HCC at 90 day f/u, and 11 HCC and 5 non-HCC at 180 day f/u.|||Participants|||Count of Participants
2628511|NCT01877187|Secondary|Baseline Enhancing Tumor and Response by WHO Criteria|Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by WHO criteria. Responders are subjects that demonstrated Complete Response or Partial Response by WHO criteria. Nonresponders are all other subjects.|30 days, 90 days, 180 days|16 HCC and 14 non-HCC subjects had applicable data for analysis at 30day f/u, 9 HCC and 6 non-HCC at 90 day f/u, and 9 HCC and 4 non-HCC at 180 day f/u.|||% tumor enhancement||Full Range|Median
2638560|NCT01772576|Other Pre-specified|Pacing Impedance|Pacing Impedance at 3 Months Post-Implant|3 Months Post-Implant|Patients with 3 month follow-up|||Ohm||95% Confidence Interval|Mean
2628512|NCT01877187|Secondary|Tumor Response by World Health Organization (WHO) Criteria|"Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with WHO response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per WHO criteria:~Complete Response (CR): disappearance of all lesions for >= 4 weeks. Partial Response (PR): At least 50% decrease in sum of the products of diameters of target lesions.~Overall Response: CR + PR."|6 months|18 HCC and 14 non-HCC subjects had complete data for analysis at 30day f/u, 11 HCC and 7 non-HCC at 90 day f/u, and 11 HCC and 5 non-HCC at 180 day f/u.|||Participants|||Count of Participants
2628513|NCT01877187|Secondary|Baseline Enhancing Tumor and Response by mRECIST Criteria|Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by mRECIST criteria. Responders are subjects that demonstrated Complete Response or Partial Response by mRECIST criteria. Nonresponders are all other subjects.|30 days, 90 days, 180 days|16 HCC and 14 non-HCC subjects had applicable data for analysis at 30day f/u, 9 HCC and 6 non-HCC at 90 day f/u, and 9 HCC and 4 non-HCC at 180 day f/u.|||% tumor enhancement||Full Range|Median
2628514|NCT01877187|Secondary|Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (mRECIST)|"Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with mRECIST response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per modified Response Evaluation Criteria in Solid Tumors (mRECIST):~Complete Response (CR): Disappearance of all intratumoral arterial enhancement in target lesions Partial Response (PR): At least 30% decrease in the sum of the diameters of viable (enhancement in the arterial phase) target lesions Overall Response (OR) = CR + PR"|30 days, 90 days, and 180 days|18 HCC and 14 non-HCC subjects had complete data for analysis at 30day f/u, 11 HCC and 7 non-HCC at 90 day f/u, and 11 HCC and 5 non-HCC at 180 day f/u.|||Participants|||Count of Participants
2628515|NCT01877187|Primary|Baseline Enhancing Tumor and Response by RECIST Criteria|Analysis of enhancing tumor (% of tumor that arterially enhances on MRI imaging) to correlate with responders/nonresponders by RECIST criteria. Responders are subjects that demonstrated Complete Response or Partial Response by RECIST criteria. Nonresponders are all other subjects.|30 days, 90 days, 180 days|16 HCC and 14 non-HCC subjects had applicable data for analysis at 30day f/u, 9 HCC and 6 non-HCC at 90 day f/u, and 9 HCC and 4 non-HCC at 180 day f/u.|||% tumor enhancement||Full Range|Median
2628516|NCT01877187|Primary|Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST)|"Lipiodol deposition in the tumor will be measured using non contrast CT. The images from the non contrast CT will also be correlated with RECIST response separately using contrast CT, MRI and PET imaging. Response rates taken at 30 days, 90 days, 180 days. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI:~Complete Response (CR): Disappearance of all target lesions Partial Response (PR): >= 30% decrease in the sum of the longest diameter of target lesions~Overall Response (OR) = CR + PR"|30 days, 90 days, and 180 days|18 HCC and 16 non-HCC subjects had complete data for analysis at 30day f/u, 11 HCC and 7 non-HCC at 90 day f/u, and 11 HCC and 5 non-HCC at 180 day f/u.|||Participants|||Count of Participants
2628517|NCT01877161|Primary|The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham)|"Reaction time for lexical and repetition test were measured before and after the TMS stimulation at each sessions (at session 1, session 2, session 3 over MTG/STG/Sham; MTG: middle temporal gyrus, STG: superior temporal gyrus).~Response times were measured via the response pad, and spoken responses were recorded via a SV-1 Voice Key apparatus.~The reaction time post TMS - reaction time pre TMS were used for analysis.* Arm/Group Title Arm/Group Description Maximum length (999) Repetitive magnetic stimulation (rTMS) were applied over STG"|change between before and after the TMS stimulation for each sessions (at session 1, session 2, session 3)||||msec||Standard Deviation|Mean
2628518|NCT01877148|Other Pre-specified|Change From Jebsen-Taylor Hand Function Test - Jebsen Test|The Jebsen-Taylor Hand Function Test assesses a broad range of uni-manual hand functions required for activities of daily living. Seven subtests are performed on both non-dominant and dominant hand: 1. Writing a 24-letter, 3rd grade reading difficulty sentence 2... Total score = sum of times for each subtests. Shorted times are indicative of better hand function|At baseline, after 1 month||||minutes||Standard Error|Mean
2628519|NCT01877148|Other Pre-specified|Change From Parkinson Disease Quality of Life - PDQL|"Parkinson disease quality of life is the sum of 37 questions, total score ranging from 0 (best possible outcome) to 185 (worst possible outcome), as accurate and appropriate"|at baseline, after 1 month||||units on a scale||Standard Error|Mean
2628520|NCT01877148|Secondary|Change From Cortical Excitability Via Single Transcranial Magnetic Stimulation||per sesssion: at baseline and after physical therapy||||milivolt||Standard Error|Mean
2628521|NCT01877148|Primary|Change From Unified Parkinson´s Disease Rating Scale - UPDRS|"Unified Parkinson´s Disease Rating Scale is the sum of 27 questions, total score ranging from108 (best possible outcome) to 0 (worst possible outcome), as accurate and appropriate"|At baseline, after 1 month||||units on a scale||Standard Error|Mean
2628522|NCT01877083|Secondary|Plasma Concentrations of Lenvatinib||Cycle 1 Day 1: 0.5-4 hours, 6-10 hours postdose; Cycle 1 Day 15: predose, 0.5-4 hours, 6-10 hours postdose; Cycle 2 Day 1: predose, 2-12 hours postdose; Cycle 3 Day 1: predose; (Cycle length is equal to [=] 28 days)|The pharmacokinetic (PK) Analysis Set included all participants who received at least one dose of lenvatinib and had at least one quantifiable lenvatinib concentration. Participants who were evaluable at a particular time point for this outcome measure were included in the assessment.|||microgram per milliliter (mcg/mL)||Full Range|Median
2628523|NCT01877083|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first dose to the date of death from any cause. OS was calculated using Kaplan-Meier estimate and presented with 2-sided 95% Cl based on the Greenwood formula.|From first dose date until date of death from any cause (approximately up to 2 years 10 months)|FAS included all participants who received at least 1 dose of lenvatinib.|||months||95% Confidence Interval|Median
2628537|NCT01876823|Secondary|Change in Trails B|Change from baseline to Week 48 on Trails B: Measures attention and executive function. It asks patients to connect numbers and letters in numerical to alphabetical order from (1-13 and A-L) as fast as they can. Patients are timed; the longer it takes for the patient to connect the numbers and letters, the worse their score. Unit of measure is in seconds. The amount of errors that the patient makes during trails is also recorded.|Baseline, Week 48|Analysis was intent to treat.|||seconds||Standard Deviation|Mean
2628524|NCT01877083|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the first dose to the date of first documentation of PD, or date of death, whichever occurred first. Tumor response data used to analyze PFS was obtained from the investigator's assessment of the imaging scans using RECIST 1.1. No independent review of tumor assessments were performed. PFS was calculated using Kaplan-Meier estimate and presented with 2-sided 95% Cl based on the Greenwood formula. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions.|From first dose date until PD or death (up to approximately 2 years 10 months)|FAS included all participants who received at least 1 dose of lenvatinib.|||months||95% Confidence Interval|Median
2628525|NCT01877083|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), based on the investigator assessment of radiologic response according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. No independent review of tumor assessments was performed. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (<) 10 millimeter (mm). PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From first dose date until PD, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment (up to approximately 2 years 10 months)|FAS included all participants who received at least 1 dose of lenvatinib.|||percentage of participants||95% Confidence Interval|Number
2628526|NCT01876992|Other Pre-specified|Effect of Dose Escalation|Compare the effect of dose escalation of metformin on CBP phosphorylation in white blood cells in both in vivo and ex vivo assays to subsequent physiological changes in vivo for adults and children. CBP phosphorylation will be measured by western blot analysis using a probe that is specific for the phosphorylated CBP protein. The outcome will be the % difference between the patient before starting metformin and at each dose increment.|Approximately Week 10|Escalating CBP phosphorylation was measured.|||percent phosphorylation||Full Range|Mean
2628527|NCT01876992|Secondary|Fasting Blood Glucose.|A fasting blood sugar level less than 100 mg/dL is normal. A fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes. If a subject has a blood sugar of 126 mg/dL or higher on two separate tests, they are diagnosed with diabetes. Metformin decreases fasting blood sugar.|30 days|Data were not collected for this outcome measure.||||||
2628528|NCT01876992|Secondary|Change in BMI|The BMI is an index measure of body weight and is used to define states of obesity. Height ( in meters) and weight (in Kilograms) are used to calculate a BMI (kg/m2).|Baseline and after about 30 days||||change in BMI (kg/m2)||Full Range|Mean
2628529|NCT01876992|Primary|% Cyclic Amine Mono Phosphate (cAMP) Response Element Binding Protein (CBP) White Blood Cell (WBC) Phosphorylation (Metformin Treated vs no Treatment)|To assess metformin-induced Cyclic Amine Mono Phosphate (cAMP) response element binding protein (CBP) phosphorylation in circulating white blood cells both in vivo and ex vivo and determine its relationship to subsequent changes in body mass index, fasting blood glucose.|10 weeks||||percent phosphorylation||Full Range|Mean
2628530|NCT01876979|Primary|Time|Time duration for the application of device, in minutes.|Time duration of placement of device in operating room||||minutes||Full Range|Mean
2628531|NCT01876823|Other Pre-specified|Conversion to Dementia Using Clinical Dementia Rating (CDR)|The CDR is a numeric rating scale that is used to quantify the severity of one's cognitive function. The scale goes from 0=normal; 0.5=mild cognitive impairment; 1 to 3=mild to moderate/severe dementia. CDR was used a dichotomous outcome measure (no=0; yes=1).|Baseline, Week 48|Analysis was intent to treat; ANOVA repeated measures. All values of data collected were included, except for those who exited the study early. In these cases, their last observation was carried forward (LOC).|||participants|||Number
2628532|NCT01876823|Other Pre-specified|Change in Clinical Global Impression - Cognitive Change|The CGI Cognitive Change follows a seven-point likert scale. Compared to the patient's condition at baseline in the study [prior to medication initiation], the patient's condition is rated as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. Responses from the entire group were calculated. Mean at final visit and baseline is reported below.|Baseline, Week 48|Analysis was intent to treat; ANOVA repeated measures. All values of data collected were included, except for those who exited the study early. In these cases, their last observation was carried forward (LOC).|||units on a scale||Standard Deviation|Mean
2628533|NCT01876823|Other Pre-specified|Change in Clinical Global Impression - Depression Change|The CGI Depression Change follows a seven-point likert scale. Compared to the patient's condition at baseline in the study [prior to medication initiation], the patient's condition is rated as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. Responses were calculated for the entire group. Mean at final visit has been reported below. Higher mean at baseline indicates a decrease in depression scores.|Baseline, Week 48|Analysis was intent to treat; ANOVA repeated measures. All values of data collected were included, except for those who exited the study early. In these cases, their last observation was carried forward (LOC).|||units on a scale||Standard Deviation|Mean
2628534|NCT01876823|Other Pre-specified|Change in Treatment Emergent Side Effects (TESS)|"Somatic side effect rating scale which includes 26 common somatic side effects associated with previous medication clinical trials; rated by the study physician. Factors were dichotomized to yes or no responses on this scale, which equated to the symptom being either present or not present. Yes and no responses were given a value of 0 (no) or 1 (yes). Responses from the entire group were calculated and the mean at baseline and the last visit is reported below."|Baseline, Week 48|Analysis was intent to treat.|||units on a scale||Standard Deviation|Mean
2628535|NCT01876823|Other Pre-specified|Change in 24-item HAMD|Change in 24-item Hamilton Rating Scale for Depression (HAMD) scores from baseline to Week 48: HAMD measures depression severity based on a series of 24 items items. The range of HAMD total score is 0-74; 0 indicates no depressive symptoms and a maximum HAMD score is a 74, where the greater the score indicates more significant psychopathology. In this study, moderate to severe depression is considered a HAMD-24 greater than 14.|Baseline, Week 48|Analysis was intent to treat.|||scores on a scale||Standard Deviation|Mean
2628538|NCT01876823|Secondary|Change in Selective Reminding Test - Delayed Recall (SRT-DR)|Change in Selective Reminding Test-Delayed Recall scores from baseline to Week 48: SRT Delay is administered 15 minutes after the immediate recall portion. Patients are asked to remember as many of the words as they can from the 6 trials. Maximum raw score is a 12 for free recall. If a patient is unable to recall a word, they are given a chance to recognize it among three incorrect word choices. Maximum raw score for recognition is 12. The greater the score on the delayed recall portion, the better the patient does on the assessment.|Baseline, Week 48|Analysis was intent to treat.|||units on a scale||Standard Deviation|Mean
2628539|NCT01876823|Secondary|Change in Wechsler Memory Scale-III (WMS-III)|Change in Wechsler Memory Scale-III scores from baseline to Week 48: The WMS-III Visual Reproduction sub-test was used to measure visual working memory and delayed memory. Patients were shown pictures of four drawings and were asked to reproduce them from memory immediately after seeing them, and 25 minutes after seeing them. The four scores are summed and the greater the total raw score, the better the patient did on the assessment. The maximum raw score for this test is a 41 on both the immediate and delayed portions (the overall range is 0-82 points). The change score is calculated using the total scores of both the immediate and delayed portions.|Baseline, Week 48|Analysis was intent to treat.|||units on a scale||Standard Deviation|Mean
2628540|NCT01876823|Primary|Change in Selective Reminding Test - Total Immediate Recall (SRT-IR)|Change in Selective Reminding Test-Total Immediate Recall (SRT-IR) scores from baseline to Week 48: Measures word recall (maximum 12 words per trial, across 6 trials). Maximum total recall score across 6 trials is 72; minimum recall is 0 across 6 trials. The higher the raw score, the better the patient did at recalling the target words. The unit of measure is the raw score, or the sum of the number of words recalled across all 6 trials.|baseline, 48 weeks|Analysis was intent to treat.|||units on a scale||Standard Deviation|Mean
2628541|NCT01876810|Other Pre-specified|Cue- Reactivity Visual Analogue Scale for Craving After 1 Week of Treatment|In this study, each session started with participants taking four puffs of their preferred-brand cigarette to standardize the time from last nicotine exposure. Participants were then seated in a comfortable chair and completed the baseline Visual Analogue Scale for craving 0-100 mm (The higher the number the more is the craving). The smoking cue was a pack of cigarettes and a lighter. Participants were instructed to light the cigarette without puffing and hold it for 30 sec while the physiological recordings were measured. Then the participant was asked to extinguish the cigarette. The neutral cue was an unsharpened pencil, a notepad, and a sharpener. Participants were instructed to sharpen the pencil and hold it as if writing for 30 sec. Participants completed the Visual Analogue Scale for craving during the cue, and 15 and 30 min after cue presentation.|during the lab Cue- reactivity paradigm after 1 week of treatment|participants self-reportd Visual analogue scale (0-100 mm) for craving at the time of presenting the smoking cue. The higher the number on the scale, the more is the craving|||units on a scale: from 0-100 mm||Standard Error|Mean
2628542|NCT01876810|Secondary|The Percentage of Choice of Nicotinized Cigarettes After 1 Week of Treatment|"Percentage of choice of Nicotinized cigarettes was calculated for each participant during the lab session which took place after 1 week of treatment.~Each session started with participants taking four puffs of their preferred-brand cigarette to standardize the time from last nicotine exposure. Participants were asked to complete some questionnaires at baseline. Then, they were asked to relax for 30 min listening to music or reading. Four exposure trials followed that were separated by 30 min of relaxation. In each exposure trial, participants took four puffs of a Nicotinized (A) or Denicotinized (less than 0.05 mg nicotine.) (B) cigarette in the order of ABAB or BABA. Cigarettes were color-coded. Participants then began four choice trials separated by 30 min of relaxation. In each trial, participants chose any combination of 4 puffs from the two cigarettes."|during the lab forced choice paradigm after 1 week of treatment||||percentage of choice of nicotinized ciga||Standard Error|Mean
2628543|NCT01876810|Primary|Number of Days With Self-report of No Smoking and Breath Carbon Monoxide of <5 PPM During Quit-attempt Weeks|the number of days of no smoking was calculated for each participant. Abstinence was verified by daily Self-reports of no smoking and breath carbon monoxide < 5 ppm|1 week in each phase||||days||Standard Error|Mean
2628544|NCT01876784|Secondary|Evaluation of the Pharmacokinetics of Vandetanib in the Patient Population by Assessment of CL/F|Estimated time frame up to 155 progression events have occurred or up to individual progression of patient.|Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter until discontinuation.|||||||
2628545|NCT01876784|Secondary|Evaluation of the Pharmacokinetics of Vandetanib in the Patient Population by Assessment of AUCss|Estimated time frame up to 155 progression events have occurred or up to individual progression of patient.|Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter until discontinuation.|||||||
2628546|NCT01876784|Secondary|Evaluation of the Pharmacokinetics of Vandetanib in the Patient Population by Assessment of Cmax|Estimated time frame up to 155 progression events have occurred or up to individual progression of patient.|Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter until discontinuation.|||||||
2628547|NCT01876784|Secondary|Evaluation of the Pharmacokinetics of Vandetanib in the Patient Population by Assessment of V/F.|Estimated time frame up to 155 progression events have occurred or up to individual progression of patient.|Blood sampling at 4-6 hours post-dose at Weeks 1, 2, 4, 8, 12 and then every 12 weeks thereafter until discontinuation.|||||||
2628548|NCT01876784|Secondary|Determination of the Efficacy of Vandetanib When Compared to Placebo in the Patient Population as Assessed by Efficacy Variables Including Overall Survival|Once 155 progression events have occurred when 25% of randomized patients have died due to any cause.|Estimated time frame at 20 months after initial 25.5 months.|||||||
2628549|NCT01876784|Secondary|Determination of the Efficacy of Vandetanib When Compared to Placebo in the Patient Population as Assessed by Efficacy Variables Including Change in Tumour Size|Once 155 progression events have occurred.|Assessed tumour size at screening, Weeks 7, 8 and then every 12 weeks thereafter and at Discontinuation visit, estimated time frame at 25.5 months.|||||||
2628550|NCT01876784|Secondary|Determination of the Efficacy of Vandetanib When Compared to Placebo in the Patient Population as Assessed by Efficacy Variables Including Objective Response Rate.|Once 155 progression events have occurred.|Estimated time frame up to 25.5 months (18 months recruitment period plus 7.5 months follow up). RECIST measurements taken every 12 weeks from randomization|||||||
2628553|NCT01876784|Secondary|Determination of the Efficacy of Vandetanib When Compared to Placebo in the Patient Population as Assessed by Efficacy Variables Including Duration of Response.|Once 155 progression events have occurred.|Estimated time frame up to 25.5 months (18 months recruitment period plus 7.5 months follow up). RECIST measurements taken every 12 weeks from randomization|||||||
2628554|NCT01876784|Primary|Progression-Free Survival (PFS)|The PFS was defined as the time (in months) from randomization until the date of first documented disease progression or death (from any cause), whichever came first. Disease progression as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) was defined as: at least a 20% increase and absolute increase of 5 mm in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Analysis was performed by Kaplan-Meier method.|Randomization until disease progression or death, assessed every 12 weeks (up to 22 months)|Intent to treat population included all randomized participants.|||months||95% Confidence Interval|Median
2628555|NCT01876732|Secondary|Change in Quality of Life|The scoring procedure for the KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease),first transforms the raw precoded numeric values of items to a 0-100 possible range with higher transformed scores reflecting a better quality of life. Each item is put on a 0 to100 range so that the lowest and highest possible scores are set at 0 and100, respectively. The results entered in the outcome data is the mean absolute difference between the mean pre-test score and the mean post-test score.|3 month|Subjects were asked to complete a KDQOL-36 (Kidney Disease Quality of Life Instrument adopted for quality of life assessment of patients with kidney disease), once prior to therapy, and then again at the end of 3 months when therapy (when therapy is completed), was completed. Pre and post results will be compared.|||Scores on a Scale||Standard Deviation|Mean
2628556|NCT01876732|Primary|Change in Amount of Epogen Required|The effects of Vitamin B12 supplementation on erythropoitin alpha (Epogen) requirements in HD patients|Baseline and 4 months||||unit/ml||Standard Deviation|Mean
2628557|NCT01876706|Secondary|QMAX Median at Baseline and 12 Months With CI 95%|QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate is obstructive.|12 Month||||mL/sec||95% Confidence Interval|Median
2628558|NCT01876706|Secondary|IPSS at Baseline and 12 Months, Median , 95% CI|"The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores are indicative of less symptoms.~Score Correlation[1] 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic"|12 Month||||IPSS total score||95% Confidence Interval|Median
2628559|NCT01876706|Secondary|BPHII Baseline and 12 Month Median Score, 95% CI|"BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.~Questions 1-4:~Over the past month how much physical discomfort did any urinary problems cause you? &~Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.~Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.~Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time."|12 Month||||BPHII total score||95% Confidence Interval|Median
2628560|NCT01876706|Secondary|Pain Tolerability Throughout the UroLift System Procedure|Pain Tolerability using questionnaire pelvic pain Visual Analog Scale (VAS) 0-10. A score of 0 (zero) would equal no pain while a score of 10 would equate to pain as bad as patient could imagine. This scale was assessed at different times during procedure as specified in results section.|12 Month|Pain Tolerability throughout the UroLift System Procedure|||units on a scale||Full Range|Mean
2628561|NCT01876706|Secondary|QMAX 12 Month Percent (%) Change in mL/Sec From Baseline|QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra. The larger Percent (%) Change of the QMAX value at 12 Month Follow-up from Baseline, demonstrate the improvement in QMAX. Note: Percent (%) Change: is the average %change of each subject|12 Months|QMAX maximum peak urinary flow rate, if valid void >125ml at baseline and 12 months. Urinary flow rate overread by independent reviewer. Note that n=33 pertains to those subjects where a valid void was received, therefore 8 subject flows were either not valid or were not received.|||percentage change||95% Confidence Interval|Mean
2628562|NCT01876706|Secondary|QMAX 12 Month Change Minus Baseline|QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra. The larger number for Change of the QMAX value at 12 Month Follow-up minus Baseline, demonstrate the improvement in QMAX|12 Months|QMAX maximum peak urinary flow rate, if valid void >125ml at baseline and 12 months. Urinary flow rate overread by independent reviewer. Note that n=33 pertains to those subjects where a valid void was received, therefore 8 subject flows were either not valid or were not received.|||mL/sec||Standard Deviation|Mean
2628563|NCT01876706|Secondary|Qmax Scores at Baseline and 12 Month Follow-up|QMAX indicates the maximum flow rate during a Uroflow in mL/sec. QMAX is used as an indicator for the diagnosis of enlarged prostate. A lower QMAX may indicate that the enlarged prostate puts pressure on the urethra.|12 Month|QMAX maximum peak urinary flow rate, if valid void >125ml at baseline and 12 months. Urinary flow rate overread by independent reviewer. Note that n=33 pertains to those subjects where a valid void was received, therefore 8 subject flows were either not valid or were not received.|||mL/sec||Standard Deviation|Mean
2628575|NCT01876511|Secondary|Objective Response Rate (ORR) in MSI Positive and Negative Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)|ORR is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions.|28 months||||percentage of participants||95% Confidence Interval|Number
2628564|NCT01876706|Secondary|BPH II 12 Month Change From Baseline|"BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.~Questions 1-4:~Over the past month how much physical discomfort did any urinary problems cause you? &~Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.~Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.~Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time."|12 Months||||BPHII total score||Standard Deviation|Mean
2628565|NCT01876706|Secondary|BPH II 12 Month Percent (%) Change From Baseline|"BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.~Questions 1-4:~Over the past month how much physical discomfort did any urinary problems cause you? &~Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.~Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.~Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time."|12 Months||||percentage change||95% Confidence Interval|Mean
2628566|NCT01876706|Secondary|BPH II Scores at Baseline and 12 Month Follow-up|"BPH Impact Index (BPH II) A validated questionnaire to measure how much urinary problems of patients with benign prostatic hyperplasia affect domains of health. BPHII total score is the combined (sum) of scores for Questions 1-4 (sum range of 0-13 scoring is presented below) MAX of 13 would be 3,3,3,and 4: A score of zero = Patient experiences no BPH impact and does not add any to score.~Questions 1-4:~Over the past month how much physical discomfort did any urinary problems cause you? &~Over the past month, how much did you worry about your health because of any urinary problems? 0 None, 1, 2, 3 A lot.~Overall, how bothersome has any trouble with urination been during the past month? 0 Not at all bothersome,1,2,3 Bothers me a lot.~Over the past month, how much of the time has any urinary problems kept you from doing the kind of things you would usually do? 0 None of the time, 1,2,3, 4 All of the time."|12 Month||||BPHII total score||Standard Deviation|Mean
2628567|NCT01876706|Secondary|IPSS 12 Month Percent (%) Change From Baseline|"The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH) using a total score from 0 - 35.~The larger Percent (%) Change in IPSS Score at 12 Month Follow-up from Baseline, demonstrates the improvement in IPSS (the mean score was change by X %). Note: Percent (%) Change: is the mean % change of each subject."|12 Months||||percentage change||95% Confidence Interval|Mean
2628568|NCT01876706|Secondary|IPSS 12 Month Change From Baseline|"The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH) using a total score from 0 - 35.~The larger number for Change in IPSS Score 12 Month Follow-up from Baseline, demonstrate the improvement in IPSS."|12 Months||||scores on a scale||Standard Deviation|Mean
2628569|NCT01876706|Secondary|IPSS Scores at Baseline and 12 Month Follow-up|"The International Prostate Symptom Score (IPSS) is an 7 question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Lower scores are indicative of less symptoms.~Score Correlation[1] 0-7 Mildly symptomatic 8-19 Moderately symptomatic 20-35 Severely symptomatic"|12 Months||||IPSS total score||Standard Deviation|Mean
2628570|NCT01876706|Primary|Quality of Recovery|Primary effectiveness will be achieved when 80% (95% lower confidence limit) of subjects achieve a score of 80 or more on the Quality of Recovery Visual Analog Scale (QoR VAS) by the one month follow-up visit. The VAS scale is 0-100, with 100 being 100% recovery.|1 Month||||participants|||Number
2628571|NCT01876511|Secondary|Does MSI as a Marker Predict Treatment Response|ORR was used to determine whether MSI is a marker that predicts treatment response. This is the same data presented in outcome measure number 8 (ORR, to test against null of 5%).|28 months||||percentage of participants||95% Confidence Interval|Number
2628572|NCT01876511|Secondary|Disease Control Rate in MSI Positive and Negative Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)|Disease Control Rate (DCR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.|28 months||||percentage of participants||95% Confidence Interval|Number
2628573|NCT01876511|Secondary|Progression Free Survival (PFS) at 28 Weeks in MSI Positive and Negative Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)|PFS is defined as the percentage of patients with disease progression (PD or relapse from CR as assessed using RECIST 1.1 criteria) or death due to any cause at 28 weeks. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.|28 weeks||||percentage of participants||95% Confidence Interval|Number
2628574|NCT01876511|Secondary|Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity|When calculating the incidence of AEs, each adverse event (AE) (as defined by NCI CTCAE v4.03) will be counted only once for a given subject.|28 months||||Participants|||Count of Participants
2628585|NCT01876446|Secondary|Incidence of Adverse Events, Assessed Using NCI CTCAE v 4.0|"Count of participants by maximum graded according to NCI CTCAE v 4.0 of any adverse event by arm.~Please refer to the adverse event reporting for more detail."|Up to 30 days|All treated and eligible patients|||Participants|||Count of Participants
2628576|NCT01876511|Secondary|Immune-related Progression Free Survival (irPFS) at 28 Weeks in MSI Positive and Negative Solid Tumor Malignancies Using Immune Related Response Criteria (irRC)|irPFS rate is defined as the percentage of patients with disease progression (irPD or relapse from irCR as assessed using irRC criteria) or death due to any cause at 28 weeks. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation, Stable Disease (irSD) is the failure to meet criteria for irCR or irPR (in absence of irPD), Progressive Disease (irPD) is at least 25% increase in tumor burden relative to nadir. Estimation based on the Kaplan-Meier curve.|28 weeks||||percentage of participants||95% Confidence Interval|Number
2628577|NCT01876511|Secondary|Overall Survival (OS)|OS will be measured from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.|4 years||||Weeks||95% Confidence Interval|Median
2628578|NCT01876511|Primary|Progression Free Survival (PFS) at 20 Weeks in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)|For Cohorts A and C: PFS is defined as the percentage of patients with disease progression (PD or relapse from CR as assessed using RECIST 1.1 criteria) or death due to any cause at 20 weeks. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.|20 weeks|It was a pre-specified objective to complete this objective in Cohort A and C only.|||percentage of participants||95% Confidence Interval|Number
2628579|NCT01876511|Primary|Objective Response Rate in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)|For Cohorts A and C: Objective Response Rate (ORR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions.|28 months|It was a pre-specified objective to complete this objective in Cohort A and C only.|||percentage of participants||95% Confidence Interval|Number
2628580|NCT01876511|Primary|Immune-related Progression Free Survival (irPFS) at 20 Weeks in MSI Positive Non-colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2|For Cohort C: irPFS rate is defined as the percentage of patients with disease progression (irPD or relapse from irCR as assessed using irRC criteria) or death due to any cause at 20 weeks. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation, Stable Disease (irSD) is the failure to meet criteria for irCR or irPR (in absence of irPD), Progressive Disease (irPD) is at least 25% increase in tumor burden relative to nadir. Estimation based on the Kaplan-Meier curve.|20 weeks|It was a pre-specified objective to complete this objective in Cohort C only. Per protocol during stages 1 and 2, the study enrollment goal was 21 for Cohort C. Additional subjects for this study were enrolled during the second expansion portion of this protocol.|||percentage of participants||95% Confidence Interval|Number
2628581|NCT01876511|Primary|Immune-related Objective Response Rate in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2|For Cohorts A and B: Immune-related Objective Response Rate (irORR) is defined as the percentage of patients achieving a complete response (irCR) or partial response (irPR) based on irRC criteria. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation.|28 months|It was a pre-specified objective to complete this objective in Cohort A and B only. Per protocol during stages 1 and 2, the study enrollment goal was 25 for Cohort A and B. However, only 24 subjects were enrolled in Cohort A. Additional subjects for this study were enrolled during the second expansion portion of this protocol.|||percentage of participants||95% Confidence Interval|Number
2628582|NCT01876511|Primary|Immune-related Progression Free Survival (irPFS) at 20 Weeks in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2|For Cohorts A and B: irPFS rate is defined as the percentage of patients with disease progression (irPD or relapse from irCR as assessed using irRC criteria) or death due to any cause at 20 weeks. Per irRC criteria, Complete Response (irCR) is the disappearance of all target lesions, Partial Response (irPR) is a decrease in tumor burden by 50% or greater by a consecutive assessment at least 4 weeks after first documentation, Stable Disease (irSD) is the failure to meet criteria for irCR or irPR (in absence of irPD), Progressive Disease (irPD) is at least 25% increase in tumor burden relative to nadir. Estimation based on the Kaplan-Meier curve.|20 weeks|It was a pre-specified objective to complete this objective in Cohort A and B only. Per protocol during stages 1 and 2, the study enrollment goal was 25 for Cohort A and B. However, only 24 subjects were enrolled in Cohort A. Additional subjects for this study were enrolled during the second expansion portion of this protocol.|||percentage of participants||95% Confidence Interval|Number
2628583|NCT01876485|Primary|Change in Diabetes Specific Quality of Life|The Diabetes Distress Scale (DDS) will be used to assess diabetes quality of life throughout the study. Minimum value: 1; Maximum value: 6. Higher scores indicate a higher level of diabetes distress.|Diabetes specific quality of life will be measured at baseline, four months, and ten months.|"Seven participants did not complete the DDS at baseline. Therefore, sample sizes for DDS are lower than for HbA1c.~Although not all of the 138/135 per group with DDS at baseline completed each the post-intervention and maintenance assessments, intent to treat analyses were conducted which enabled us to use the full number across time points."|||Units On A Scale||Standard Deviation|Mean
2628584|NCT01876485|Primary|Changes in Percent Glycosylated Hemoglobin (HbA1c) Levels During Intervention|Measures of HbA1c will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control.|HbA1c levels will be measured at baseline, four months, and ten months.|Although not all of the 140 per group with HbA1c at baseline completed each the post-intervention and maintenance assessments, intent to treat analyses were conducted which enabled us to use the full 140 across time points.|||Percentage/DCCT||Standard Deviation|Mean
2654528|NCT01634854|Secondary|Maternal Delivery Outcomes|Maternal delivery outcomes|Through discharge from hospital||||Participants|||Count of Participants
2628587|NCT01876446|Secondary|Best Response|"Count of participants by best response, defined as best objective status recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since treatment started), measured by RECIST 1.1~Tumor response is defined as a complete response (CR) or partial response (PR) by RECIST 1.1 criteria, which will be evaluated by CT scan every other cycle. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Up to 30 days|All treated and eligible patients|||Participants|||Count of Participants
2628588|NCT01876446|Secondary|Mean Duration of Response|The mean duration of response for those participants that responded to treatment by arm.|Time from registration to death due to any cause, assessed up to 3 years|All participants that responded to treatment|||months||Standard Deviation|Mean
2628589|NCT01876446|Secondary|Objective Tumor Response Measured With Response Evaluation Criteria in Solid Tumors (RECIST) 1.1|Objective tumor response will be tabulated overall (and by dose level if appropriate). Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in the cohorts (overall and by tumor group).|Up to 30 days|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2628590|NCT01876446|Primary|18 Week Progression-free Survival Rate|The distribution of time to disease progression will be estimated in each group using the method of Kaplan-Meier at 18 weeks.|Time from registration to the date of first documented disease progression or death, assessed at 18 weeks|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2628591|NCT01876420|Secondary|Resheath or Recapture Success Rate (When Attempted), Where Successful Recapture is Defined as Evolut R™ TAV (Including the Frame) is Fully Resheathed Into the Capsule of the Delivery Catheter, as Verified by Fluoroscopy.|Resheath or Recapture success rate (when attempted), where successful recapture is defined as Evolut R™ TAV (including the frame) is fully resheathed into the capsule of the delivery catheter, as verified by fluoroscopy. Resheathing or recapturing of the TAV was attempted on 15 subjects.|Day 1|Subjects who had either a resheath or recapture attempt at implant and the success rate for each resheathing, or recapturing attempts of the valve at the implant.|||percentage of successful attempts|Research recapture attempts||Number
2628592|NCT01876420|Secondary|Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Total Aortic Regurgitation (Transvalvular & Paravalvular)|Degree of Total prosthetic valve regurgitation (transvalvular & paravalvular)|30 days|All implanted subjects who had echos at the 30 day visit, which were 58 subjects, and 58 of the echos were able to measure the Total Aortic Regurgitation for those subjects.|||percentage of participants|||Number
2628593|NCT01876420|Secondary|Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - • Effective Orifice Area (EOA)|Effective orifice area|30 days|All implanted subjects who had echos at the 30 day visit, which were 58 subjects, only 54 of the echos were able to measure the EOA for those subjects.|||cm²||Standard Deviation|Mean
2628594|NCT01876420|Secondary|Hemodynamic Performance Metrics at 30 Days by Doppler Echocardiography - Mean Gradient|The hemodynamic performance will be measured by the Mean Prosthetic Valve Gradient for 59 subjects, measured with the Doppler echocardiography.|30 days|All implanted subjects who had echos at the 30 day visit, which were 58 subjects, only 57 of the echos were able to measure the Mean Gradient for those subjects.|||mmHg||Standard Deviation|Mean
2628595|NCT01876420|Secondary|Event Rates of the Individual Components of the VARC II Composite Safety Endpoint at 30 Days|The Individual components of the VARC II composite safety endpoint at 30 days per the Kaplan Meier Event Rate (%).|30 days|The number of subjects analyzed at 30 days.|||percentage of probability|||Number
2628596|NCT01876420|Secondary|VARC II Combined Safety Endpoint at 30 Days|The VARC II Combined Safety Endpoint at 30 days includes the following components: All-Cause Mortality, All Stroke, Life Threatening or Disabling Bleeding, Acute Kidney Injury: Stage 2 or 3, Coronary Artery Obstruction, Major Vascular Complication, and Valve-Related Dysfunction Requiring Repeat Procedure.|30 days||||percentage probability|||Number
2628597|NCT01876420|Primary|Device Success Rate at 24 Hours to Seven Days|"Device success rate at 24 hours to seven days, defined as:~Absence of procedural mortality, AND~Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND~Intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity < 3 m/sec), AND absence of moderate or severe prosthetic valve regurgitation.~The percentage of subjects with no more than mild aortic regurgitation at early post procedure echocardiogram (24 hours through seven days)."|24 hours to seven days|All implanted subjects at 30 days.|||percentage of participants|||Number
2628598|NCT01876420|Primary|Stroke Rate (Disabling and Non-disabling) at 30 Days|The Stroke rate (disabling and non-disabling) at 30 days per the VARC II definitions. Stroke is defined as an acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction. Stroke may be classified as ischaemic or haemorrhagic with appropriate subdefinitions. Ischaemic stroke is defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue. Haemorrhagic stroke is defined as an acute episode of focal or global cerebral or spinal dysfunction caused by intraparenchymal, intraventricular, or subarachnoid haemorrhage. A stroke may be classified as 'undetermined' if there is insufficient information to allow the categorization as ischaemic or haemorrhagic.|30 days|All implanted subjects at 30 days.|||percentage of participants|||Number
2628611|NCT01876368|Secondary|Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)|Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The 24-hour ABPM measurements are performed beginning 24 hours prior to baseline and week 8 visits.|baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis.|||mmHg||Standard Error|Least Squares Mean
2628697|NCT01875237|Secondary|To Assess the Incidence of GvHD Treatment Failure Post-administration of AP1903.|To assess the incidence of GvHD treatment failure, defined as no response, progression, administration of additional therapy for GvHD, or mortality post-administration of AP1903.|Day 3, 7, 14, 28, and 56 post-administration of AP1903.|Patient who received AP1903|||Participants|||Count of Participants
2628599|NCT01876420|Primary|All-cause Mortality Rate at 30 Days|"The All-cause mortality rate at 30 days per the VARC II recommendation of clinical endpoints for TAVI. More specifically:~Cardiovascular mortality (Any of the following criteria)~Death due to proximate cardiac cause (e.g. myocardial infarction, cardiac tamponade, worsening heart failure)~Death caused by non-coronary vascular conditions such as neurological events, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease~All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure~All valve-related deaths including structural or non-structural valve dysfunction or other valve-related adverse events~Sudden or unwitnessed death~Death of unknown cause Non-cardiovascular mortality~Any death in which the primary cause of death is clearly related to another condition (e.g. trauma, cancer, suicide)"|30 days|All implanted subjects at 30 days.|||percentage of participants|||Number
2628600|NCT01876381|Secondary|Change From Baseline in Total Fluid Removal Per Week by Dialysis|The total volume of fluid removed per week by dialysis at each timepoint and its change from baseline will be summarized with descriptive statistics.|Baseline (pretreatment observation period) and Intermittent Administration Period (Day 10 to Day 15)||||ml||Standard Deviation|Mean
2628601|NCT01876381|Primary|Change From Baseline in Daily Urine Volume|The daily urine volume at each timepoint and its change and the percent change from baseline will be summarized with descriptive statistics (number, mean, standard deviation [SD], minimum, median, maximum [same for following parameters]).|Baseline and Day 14 (Intermittent Administration Period)||||ml||Standard Deviation|Mean
2628602|NCT01876368|Secondary|Number of Patients With Total Adverse Events, Serious Adverse Events and Death|Number of patients with total adverse events, serious adverse events and death were reported.|8 weeks|Safety Set (SAF) - All patients who received at least one dose of study medication in the double-blind epoch. Patients were analyzed according to the treatment they received. One patient was not included in the SAF due to mis-randomization.|||Number of participants|||Number
2628603|NCT01876368|Secondary|Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response|Successful mean sitting diastolic blood pressure response is defined as msDBP <90 mmHg or a reduction ≥10 mmHg from baseline.|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS|||Participants|||Number
2628604|NCT01876368|Secondary|Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response|Successful mean sitting systolic blood pressure response is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS|||Participants|||Number
2628605|NCT01876368|Secondary|Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control|Successful mean sitting diastolic blood pressure control is defined as msDBP <90 mmHg|8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.|||Participants|||Number
2628606|NCT01876368|Secondary|Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control|Successful mean sitting systolic blood pressure control is defined as msSBP <140 mmHg|8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.|||Participants|||Number
2628607|NCT01876368|Secondary|Number of Patients Achieving Successful Overall Blood Pressure Control|Successful overall blood pressure control is defined as both msSBP/msDBP <140/90 mmHg|8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS|||Participants|||Number
2628608|NCT01876368|Secondary|Change From Baseline in Office Pulse Pressure|Mean sitting pulse pressure (msPP) will be calculated at screening through end of study at every visit. Mean sitting pulse pressure is calculated as msSBP-msDBP.|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.|||mmHg||Standard Error|Least Squares Mean
2628609|NCT01876368|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.|||mmHg||Standard Error|Least Squares Mean
2628610|NCT01876368|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean|baseline, 8 weeks|Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS.|||mmHg||Standard Error|Least Squares Mean
2639063|NCT01768013|Primary|Pharmacokinetic: Cmax of Calcipotriol|The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined|Day 14||||pg/mL||Standard Deviation|Mean
2628612|NCT01876368|Primary|Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)|Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit.|baseline, 8 weeks|A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis|||mmHg||Standard Error|Least Squares Mean
2628613|NCT01876329|Secondary|Presence of Anti-GPC Antibodies|Hypothesis: Evidence of anti-GPC Ab in a group of patients with RA will be more prevalent as compared to a group of patients with AITD and with no known systemic or organ specific autoimmune condition.|7 months||||participants|||Number
2628614|NCT01876329|Primary|Prevalence of Vitamin B12 Deficiency|Hypothesis: Evidence of serum vitamin B12 deficiency, as measure by either a low vitamin B12 level or elevated methylmalonic acid, will be more common in RA patients with anti-GPC Ab.|7 months||||participants|||Number
2628615|NCT01876251|Secondary|Percentage Change From Baseline in Notch 1 to 4 Ribonucleic Acid (RNA) in Blood|As PF-03084014 acts on the Notch pathway as an inhibitor, it is of interest to investigate its effects, if any, on the Notch family of receptors, mainly Notch 1-4.|C1D1, C1D2, C1D8, C1D21 and EOT (maximum reached: C12)|All treated participants who had at least 1 screening and post treatment biomarker assessment. n=number of evaluable participants for the specified biomarker at the specified time point.|||percentage change||Standard Deviation|Mean
2628616|NCT01876251|Secondary|Number of Participants With QTc Values Meeting Categorical Summarization Criteria|Criteria for categorical summarization of the time corresponding to the beginning of depolarization to repolarization of the ventricles (QT) corrected for heart rate (QTc) using Bazett's correction (QTcB) or Fridericia's correction (QTcF) included: maximum QTcB or QTcF less than or equal to (<=) 450 milliseconds (msec), 450 to <=480 msec, 480 to <=500 msec, more than (>) 500 msec; maximum QTcB or QTcF changes (increases/decreases) from baseline (BL) less than (<) 30 msec, 30 to <60 msec, more than or equal to (>=) 60 msec.|Screening, C1D1, C1D21, Day 1 of subsequent cycles, and EOT (maximum reached: C12)|All 29 participants who received study treatment were analyzed for safety.|||participants|||Number
2628617|NCT01876251|Secondary|Duration of Response (DR)|Duration of response (DR) defined as time from start of first documented objective tumor response [Complete Response (CR) or Partial Response (PR)] to first documented objective tumor progression or death due to any cause, whichever occurs first. DR = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.02. CR: disappearance of all target lesions. PR: at least 30% decrease in the sum of diameters of target lesions.|Baseline up to 28-35 days after treatment discontinuation (up to Day 280)|Only 4 participants had CR or PR, 2 each in the PF-03084014 100 mg BID + docetaxel 75 mg/m^2 and PF-03084014 150 mg BID + docetaxel 75 mg/m^2 groups.|||months|||Number
2628618|NCT01876251|Secondary|Ctrough of PF-03084014 in the Expansion Cohort||C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)|All 7 participants who received treatment in the expansion cohort were included in the analysis. At Cycle 1 Day 21, only 5 participants had available data for Ctrough.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2628619|NCT01876251|Secondary|Tmax of PF-03084014 in the Expansion Cohort||C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)|All 7 participants who received treatment in the expansion cohort were included in the analysis. n=number of evaluable participants at the specified time point.|||hr||Full Range|Median
2628620|NCT01876251|Secondary|Cmax of PF-03084014 in the Expansion Cohort||C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)|All 7 participants who received treatment in the expansion cohort were included in the analysis. n=number of evaluable participants at the specified time point.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2628621|NCT01876251|Secondary|AUClast of PF-03084014 in the Expansion Cohort||C1D1, C1D21, and Day 1 of subsequent cycles and at EOT (max reached: C12)|All 7 participants who received treatment in the expansion cohort were included in the analysis. n=number of evaluable participants at the specified time point.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2628622|NCT01876251|Secondary|Volume of Distribution (Vss) of Docetaxel in Dose-finding Cohort|Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)|C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)|All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.|||L||Geometric Coefficient of Variation|Geometric Mean
2628623|NCT01876251|Secondary|Terminal Half-life (t1/2) of Docetaxel in Dose-finding Cohort|Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)|C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)|All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.|||hr||Standard Deviation|Mean
2628624|NCT01876251|Secondary|Systemic Clearance (CL) of Docetaxel in Dose-finding Cohort|Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)|C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)|All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.|||liter (L)/hr||Geometric Coefficient of Variation|Geometric Mean
2628625|NCT01876251|Secondary|Tmax of Docetaxel in Dose-finding Cohort|Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)|C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)|All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.|||hr||Full Range|Median
2628626|NCT01876251|Secondary|Time to Cmax (Tmax) of PF-03084014 in Dose-finding Cohort|Serum PF-03084014 PK parameters were calculated following BID doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1)|C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)|All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.|||hr||Full Range|Median
2628627|NCT01876251|Secondary|Cmax of Docetaxel in Dose-finding Cohort|Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)|C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)|All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2628628|NCT01876251|Secondary|Maximum Serum or Plasma Concentration (Cmax) and Predose Concentration (Ctrough) of PF-03084014 in Dose-finding Cohort|Serum PF-03084014 PK parameters were calculated following BID doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1)|C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)|All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2628629|NCT01876251|Secondary|AUClast and AUC From Time 0 Extrapolated to Infinite Time (AUCinf) of Docetaxel in Dose-finding Cohort|Plasma docetaxel PK parameters were calculated following a 1-hr infusion of docetaxel given alone (Cycle 1 Day 1) and in combination with BID dosing of PF-03084014 (Cycle 2 Day 1)|C1D1, 2, 8, and 21; D1 of subsequent cycles and at EOT (max reached: C12)|All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.|||nanogram (ng)*hour (hr)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
2628630|NCT01876251|Secondary|Area Under the Concentration-time Curve (AUC) From Time 0 to Time of Last Measured Concentration (AUClast) of PF-03084014 in Dose-finding Cohort|Serum PF-03084014 pharmacokinetic (PK) parameters were calculated following twice daily (BID) doses of PF-03084014 given alone (Cycle 1 Day 21) and in combination with docetaxel (Cycle 1 Day 2 and Cycle 2 Day 1).|Cycle (C) 1 Days (D) 1, 2, 8, and 21; Day 1 of subsequent cycles and at EOT (max reached: Cycle 12)|All 22 participants treated in the dose escalation stage were included in the analysis. n=number of evaluable participants at the specified time point.|||nanogram (ng)*hour (hr)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
2628631|NCT01876251|Secondary|Percentage of Participants With Objective Response (OR)|OR was based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeters [mm]). No new lesions. PR was defined as more than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline, every 6 weeks from Cycle 2 onwards up to 26 months|All 29 participants who received study treatment were included in this analysis.|||percentage of participants||95% Confidence Interval|Number
2628632|NCT01876251|Secondary|Number of Participants With Laboratory Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick).|Baseline up to 28-35 days after treatment discontinuation (up to Day 280)|All 29 participants who received study treatment were included in the safety analyses.|||participants|||Number
2628633|NCT01876251|Secondary|Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs (TEAEs) are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Causality assessment was made by the investigator. Grading was per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death related to AE.|Baseline up to 28-35 days after treatment discontinuation (up to Day 280)|All 29 participants who received study treatment were included in the AE summarization/analysis.|||participants|||Number
2628634|NCT01876251|Primary|Progression-free Survival (PFS) at 6 Months - Expansion Cohort|The period from study entry until disease progression, death or date of last contact. Assessment of response was made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.|Baseline till 6 months post-dose|The 6-month PFS was evaluated only for the participants in the expansion cohort (PF-03084014 100 mg BID + docetaxel 75 mg/m^2). Due to early study termination, only 7 participants were treated in the expansion cohort.|||months||95% Confidence Interval|Median
2628635|NCT01876251|Primary|Number of Participants With Dose-limiting Toxicities (DLTs) in Cycle 1|Any DLT event in Cycle 1: Grade 4 neutropenia lasting more than (>)7 days; febrile neutropenia (Grade more than or equal to [>=] 3 and body temperature >=38.5 degrees Celsius); Grade >=3 neutropenic infection; Grade >=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia without bleeding; Grade >=3 toxicities (except those that had not been maximally treated); Grade 3 prolongation of time from electrocardiogram (ECG) Q wave to the end of the T wave corresponding to electrical systole (QT) corrected for heart rate (QTc) which persisted after correction of reversible causes; delay of 2 weeks in receiving next scheduled cycle due to persisting treatment-related toxicities; and failure to deliver at least 80% of planned dose during first cycle due to treatment-related toxicities.|Cycle 1 Days 1-21|All enrolled participants who were eligible, received study treatment, and who either experienced DLT during the first cycle, or completed the 1-cycle observation period.|||participants|||Number
2628636|NCT01876212|Secondary|CD8+ T Cells Infiltration|Percentage of CD8+ T cells infiltrating into melanoma lesions (tumor tissues).|Up to 6 months|Results not achievable due to insufficient patient biopsy material for the assays required for this endpoint.||||||
2628637|NCT01876212|Secondary|Suppressor Cell Populations and Blood Vessels in Melanoma Tumor Biopsies|Percentage of suppressor cell populations and blood vessels in melanoma tumor biopsies.|Up to 6 months|Results not achievable due to insufficient patient biopsy material for the assays required for this endpoint.||||||
2628639|NCT01876212|Secondary|Polymorphonucler Myeloid-derived Suppressor Cells (PMN-MDSC)|Percentage of Polymorphonucler myeloid-derived suppressor cells (PMN-MDSC) present in patients' peripheral blood. The accumulation/increase of M-MDSC populations correlates with tumor progression (disease progression) and negative prognosis.|At between 7 and 10 weeks, post treatment|Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.|||percentage of cells||Full Range|Mean
2628640|NCT01876212|Secondary|Polymorphonucler Myeloid-derived Suppressor Cells (PMN-MDSC)|Percentage of Polymorphonucler myeloid-derived suppressor cells (PMN-MDSC) present in patients' peripheral blood. The accumulation/increase of M-MDSC populations correlates with tumor progression (disease progression) and negative prognosis.|At between 4 and 6 weeks, post treatment|Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.|||percentage of cells||Full Range|Mean
2628641|NCT01876212|Secondary|Polymorphonucler Myeloid-derived Suppressor Cells (PMN-MDSC)|Percentage of Polymorphonucler myeloid-derived suppressor cells (PMN-MDSC) present in patients' peripheral blood. The accumulation/increase of M-MDSC populations correlates with tumor progression (disease progression) and negative prognosis.|At baseline (prior to treatment)|Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.|||percentage of cells||Full Range|Mean
2628642|NCT01876212|Secondary|Monocytic Myeloid Derived Suppressor Cells (M-MDSC)|Percentage of Monocytic Myeloid Derived Suppressor Cells (M-MDSC) present in patients' peripheral blood. The accumulation of M-MDSC populations correlates with tumor progression (disease progression) and negative prognosis.|At between 7 and 10 weeks, post treatment|Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.|||percentage of cells||Full Range|Mean
2628643|NCT01876212|Secondary|Monocytic Myeloid Derived Suppressor Cells (M-MDSC)|Percentage of Monocytic Myeloid Derived Suppressor Cells (M-MDSC) present in patients' peripheral blood. The accumulation of M-MDSC populations correlates with tumor progression (disease progression) and negative prognosis.|At between 4 and 6 weeks, post treatment|Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.|||percentage of cells||Full Range|Mean
2628644|NCT01876212|Secondary|Monocytic Myeloid Derived Suppressor Cells (M-MDSC)|Percentage of Monocytic Myeloid Derived Suppressor Cells (M-MDSC) present in patients' peripheral blood. The accumulation of M-MDSC populations correlates with tumor progression (disease progression) and negative prognosis.|At baseline (prior to treatment)|Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.|||percentage of cells||Full Range|Mean
2628645|NCT01876212|Secondary|Treg CD4FoxP3 Suppressor Cells|Percentage of Treg CD4FoxP3 suppressor cells in patients' peripheral blood. The accumulation of Treg CD4FoxP3 suppressor cell populations correlates with tumor progression (disease progression) and negative prognosis.|At between 7 and 10 weeks, post treatment|Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.|||percentage of cells||Full Range|Mean
2628646|NCT01876212|Secondary|Treg CD4FoxP3 Suppressor Cells|Percentage of Treg CD4FoxP3 suppressor cells in patients' peripheral blood. The accumulation of Treg CD4FoxP3 suppressor cell populations correlates with tumor progression (disease progression) and negative prognosis.|At between 4 and 6 weeks, post treatment|Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.|||percentage of cells||Full Range|Mean
2628647|NCT01876212|Secondary|Treg CD4FoxP3 Suppressor Cells|Percentage of Treg CD4FoxP3 suppressor cells in patients' peripheral blood. The accumulation of Treg CD4FoxP3 suppressor cell populations correlates with tumor progression (disease progression) and negative prognosis.|At baseline (prior to treatment)|Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.|||percentage of cells||Full Range|Mean
2628648|NCT01876212|Secondary|T Cell-recruiting Chemokine CXCL10/IP-10|Circulating serum concentration (levels) of T cell-recruiting chemokine CXCL10/IP-10 analyzed via ELISA assay. Higher levels of T cell-recruiting chemokine CXCL10/IP-1 correlate with patients exhibiting objective clinical response immunotherapy.|At between 5 and 7 weeks, post treatment|Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.|||pg/mL||Full Range|Mean
2628649|NCT01876212|Secondary|T Cell-recruiting Chemokine CXCL10/IP-10|Circulating serum concentration (levels) of T cell-recruiting chemokine CXCL10/IP-10 analyzed via ELISA assay. Higher levels of T cell-recruiting chemokine CXCL10/IP-1 correlate with patients exhibiting objective clinical response immunotherapy.|At baseline (prior to treatment)|Patients that received Vaccine (Cycle 1, Day 1) + dasatinib (Cycle 2, D1) or Vaccine + dasatinib (both agents beginning Cycle 1, D1) for which there was an analyzable PBMC sample.|||pg/mL||Full Range|Mean
2628650|NCT01876212|Secondary|Overall Survival (OS)|The length of time from the start of study treatment, that patients remain alive.|Up to 30 months|All patients enrolled in the study.|||months||95% Confidence Interval|Median
2628651|NCT01876212|Secondary|Progression-free Survival (PFS)|The length of time after study treatment that a patient lives with disease but the disease does not progress. Patients were followed for 1 year after removal from study treatment or until death, whichever occurs first. Per RECIST 1.1, Progressive Disease is defined as a ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.|Up to 15 months|Patients that received at least once cycle of study treatment who were evaluable for response using tumor measurements via radiologic evaluation.|||months||95% Confidence Interval|Median
2629190|NCT01868425|Secondary|Intraoperative Medication Use: Ketorolac and Lidocaine|All participants received standard induction medications.|From induction until arrival in post anesthesia care unit.||||mg||Standard Deviation|Mean
2628653|NCT01876212|Secondary|Objective Response Rate (ORR)|"The proportion of evaluable patients that achieved either partial or complete responses. Calculation: The number of patients who experienced a Partial Response (PR) + the number of patients who experienced a Complete Response (CR) / total number of response-evaluable patients.~Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."|Up to 13 months|Patients that received at least once cycle of study treatment who were evaluable for response using tumor measurements via radiologic evaluation.|||proportion of participants||95% Confidence Interval|Number
2628654|NCT01876212|Secondary|Best Clinical Response|The number of treated patients by best clinical response achieved (tumor measurements via radiologic evaluation) using RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.|Up to 13 months|Patients that received at least once cycle of study treatment who were evaluable for response using tumor measurements via radiologic evaluation.|||Participants|||Count of Participants
2628655|NCT01876212|Primary|Immune Response Rate|"Immune Response is defined as improved peripheral blood CD8+ T cell responses against 3 or more peptide epitopes after active vaccination with Type I-polarized autologous dendritic cell (αDC1) vaccine incorporating 6 tumor blood vessel-associated antigen (TBVA)-derived peptides.~The measure of Immune Response for this study is expressed as a proportion of responders: The number of HLA-A2+ melanoma patients with improved peripheral blood CD8+ T cell responses (responders) divided by the total number of evaluable patients."|Up to 13 months|Patients that received at least one cycle of study treatment.|||proportion of participants||95% Confidence Interval|Number
2628656|NCT01876043|Secondary|Number of Participants With a Biomarker Amplification|Genomic status of biomarkers obtained by using array-comparative genomic hybridization.|through study completion, an average of 1 year|19 patients (out of the 22 patients) for whom translational research have been performed.|||participants|||Number
2628657|NCT01876043|Secondary|Treatment Safety (AEs, SAEs and Laboratory Abnormalities) Graded According to the NCI-CTCAE Version 4.0.|Toxicity were graded according to the NCI-CTCAE version 4.0.|through study completion, an average of 1 year||||adverse events|||Number
2628658|NCT01876043|Secondary|1-year Overall Survival (OS) Rate||1 year||||percentage of overall survival||95% Confidence Interval|Number
2628659|NCT01876043|Secondary|Progression-free Survival|Progression-free survival is defined as the delay between the start date of treatment and the date of progression or death (from any cause), whichever occurs first. Patients alive and progression free were censored at the date of last follow-up, death, or last patient contact. Progression is assessed as per RECIST v1.1.|from start of study treatment to the end of the study (up to 10 months)||||months||95% Confidence Interval|Median
2628660|NCT01876043|Secondary|Percentage of Patients Remaining Alive and Progression Free at 6 Months as Per RECIST1.1.|Progression is defined using New Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), or a unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.|6 months||||percentage of participants||95% Confidence Interval|Number
2628661|NCT01876043|Secondary|Percentage of Patients With Objective Response at Six Months (as Per RECIST v1.1)|Objective response assessed as per New Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) : Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.; Overall Response (OR) = CR + PR.|6 months||||percentage of participants||95% Confidence Interval|Number
2628662|NCT01876043|Primary|Percentage of Patients Remaining Alive and Progression Free at 3 Months (i.e. Week 12 ± 1) as Per RECIST1.1 (PFS3).|Progression is defined using New Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), or a unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.|3 months|22 patients who completed study i.e who completed one cycle or two incomplete cycles of treatment were analyzed for final efficacy analysis. Out of these 22 patients who completed study, the first 17 patients (first stage of the 2-stage Simon's optimal design ) were analyzed for interim efficacy analysis based on primary endpoint.|||percentage of participants||95% Confidence Interval|Number
2628663|NCT01875991|Secondary|Strength of Preference for Autoinjector A and Autoinjector B|Strength of preference for Autoinjector A versus Autoinjector B was assessed by Question 2 of the Subject Preference Questionnaire administered after the completion of the two treatment periods at Week 8. After selecting which autoinjector they preferred overall, participants were asked to indicate how much they preferred it on a scale from 1 (Slightly), 2 (Somewhat), 3 (Strongly) and 4 (Vey Strongly).|Week 8|Primary Analysis Set|||percentage of participants|||Number
2628664|NCT01875991|Secondary|Pain Associated With Use of the Autoinjector|"Pain associated with use of the autoinjector was assessed based on responses to Question 10 of the Subject's Experience with the Autoinjector Questionnaire: Using this scale, select the circle that best describes how much it hurt when giving yourself an injection. Participants answered on a scale from 0 (No hurt) to 5 (Hurts worst). The percentage of participants who scored a 0 (No hurt) or 1 (Hurts a little bit) is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data|||percentage of participants|||Number
2628696|NCT01875237|Secondary|To Assess the Incidence of Acute GvHD Flare After CR/PR Requiring Additional Agent for Systemic Therapy Before Day 56 Post-administration of AP1903.|"To assess participants with incidence of acute GvHD flare after CR/PR requiring additional agent (including 2.5 mg/kg/day of prednisone [or methylprednisolone equivalent of 2 mg/kg/day]) for systemic therapy before Day 56 post-administration of AP1903."|before Day 56 post AP1903|Patients who received AP1903|||Participants|||Count of Participants
2628665|NCT01875991|Secondary|Satisfaction|"Satisfaction was assessed based on responses to questions 11 and 12 of the Subject's Experience with the Autoinjector Questionnaire. Question 11: How dependable (durable, sturdy, reliable) did you feel the autoinjector device was? answered on a scale from 1 (Not at all) to 5 (Very much). Question 12: Overall, how likely would you be to recommend the autoinjector to someone like you who is on etanercept? answered on a scale from 1 (Would not recommend) to 5 (Highly likely to recommend). The percentage of participants who scored either a 4 or 5 on each question is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data|||percentage of participants|||Number
2628666|NCT01875991|Secondary|Discomfort|"Discomfort was assessed based on responses to Question 9 of the Subject's Experience with the Autoinjector Questionnaire: How much discomfort did you experience when giving yourself the medicine using the autoinjector? Participants answered on a scale from 1 (None) to 5 (Very much). The percentage of participants who scored a 1 (None) or 2 (A little) is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data|||percentage of participants|||Number
2628667|NCT01875991|Secondary|Convenience|"Convenience was assessed based on responses to Question 8 of the Subject's Experience with the Autoinjector Questionnaire: How convenient was the autoinjector to use? Participants answered on a scale from 1 (Not at all) to 5 (Very much). The percentage of participants who scored a 4 (Quite a bit) or 5 (Very much) is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data|||percentage of participants|||Number
2628668|NCT01875991|Secondary|Certainty of Completing the Injection With the Autoinjector|"Certainty of completing the injection with the autoinjector was assessed based on responses to Question 7 of the Subject's Experience with the Autoinjector Questionnaire: How certain were you that you knew when the injection was finished? Participants answered on a scale from 1 (Not at all) to 5 (Extremely). The percentage of participants who scored 4 (Very) or 5 (Extremely) is reported."|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data|||percentage of participants|||Number
2628669|NCT01875991|Secondary|Ease of Use|Ease of use was assessed based on responses to questions 1 to 6 of the Subject's Experience with the Autoinjector Questionnaire: 1. How easy was it to learn how to use the autoinjector? 2. How easy was it for you to press the button to start the injection? 3. How easy was the autoinjector to use? 4. How easy was it to hold the autoinjector throughout the injection? 5. How easy was it for you to inject yourself using the autoinjector? 6. How easy was it to follow the progress of the injection? Each question was answered on a scale from 1 (Very difficult) to 5 (Very easy). The percentage of participants who scored either a 4 (Somewhat easy) or 5 (Very easy) on each question is reported.|At the end of each treatment period; Week 4 and Week 8|Full analysis set with available data|||percentage of participants|||Number
2628670|NCT01875991|Secondary|Change From Baseline in Needle Apprehension at Week 4|"Participants' needle apprehension was assessed using the Subject's Perception of Self-Injecting Questionnaire. Participants answered the question Overall how nervous are you about the needle when you think about giving yourself etanercept using the autoinjector using a scale from 1 (extremely nervous) to 5 (not at all nervous)."|Baseline and Week 4|"Full analysis set, which included all randomized participants. n indicates the number of participants with available data."|||units on a scale||Standard Deviation|Mean
2628671|NCT01875991|Primary|Percentage of Participants With a Preference for Autoinjector A Versus Autoinjector B|"Preference for autoinjector A versus autoinjector B was assessed by Question 1 of the Subject Preference Questionnaire administered after the completion of the 2 treatment periods at Week 8. Participants answered the question Which autoinjector do you prefer overall?"|Week 8|The primary analysis set consisted of all randomized participants who received at least 1 injection of Eetanercept with each autoinjector and indicated a preference for an autoinjector in the Subject Preference Questionnaire. N = number of participants with RA and PsO respectively.|||percentage of participants||95% Confidence Interval|Number
2628672|NCT01875978|Primary|Endothelial Protective Effect of Phytosterols on Patients With Non-alcoholic Fatty Liver Disease|"Ceck serum endothelial progenitor cells in the monocytes group but not in the lymphocytes group. Serum EPCs in the monocytes group provide the effect of endothelial repair to support novel vessel protection.~Cytometry flow check 150,000 cells per time including monocytes and lymphocytes group. Positive cells is the EPCs in the monocytes group. Stain with KDR, call kinase insert domain receptor, also call as VEGF receptor-2.~Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)"|after 4 weeks phytosterols 1.8g/day||||positive cells/150,000 cells||Standard Error|Mean
2628673|NCT01875978|Primary|Insulin-like Growth Factor-1 Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease|"Check serum Insulin-like growth factor-1 levels. Serum Insulin-like growth factor-1 (IGF-1) influence metabolic status and reduce EPCs apoptosis via IGF-1 receptor.~Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)"|after 4 weeks phytosterols 1.8g/day||||ng/ml||Standard Error|Mean
2628674|NCT01875978|Primary|Anti-oxidative Capacity of Phytosterols on Patients With Fatty Liver Disease|"Check serum anti-oxidative capacity, especially the serum superoxide dismutase (SOD) levels.Serum SOD provide the anti-oxidative capacity in lipid oxidation.~Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)"|after 4 weeks phytosterols 1.8g/day||||U/mg-protein||Standard Error|Mean
2628675|NCT01875978|Primary|Metabolic Effect of Phytosterols on Patients With Nonalcoholic Fatty Liver Disease|"Check serum metabolic status: levels in total cholesterol, low density lipoprotein-cholesterol, fasting glucose~Check serum anti-inflammatory status: levels in C reactive protein~Mid-point: end of first intervention (Group A: after phytosterols, Group B: after placebo) End-point: end of second intervention (Group A: after placebo, Group B: after phytosterols)"|after 4 weeks phytosterols 1.8g/day||||mg/dl||Standard Error|Mean
2628676|NCT01875874|Secondary|Number of Subjects Who Survived at the End of Study Day 28 or Who Received Orthotopic Liver Transplantation on or Before That Study Day.||Study Day 1 through Study Day 28||||Participants|||Count of Participants
2628677|NCT01875874|Primary|Overall Survival (OS) of ALF Subjects||Study Day 1 through Study Day 28||||Participants|||Count of Participants
2639064|NCT01768013|Primary|Pharmacokinetic: Cmax of Calcipotriol|The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined|Day 7||||pg/mL||Standard Deviation|Mean
2628678|NCT01875861|Secondary|Change in Site-level Rates of Management for Obesity or Weight Gain Within 30 Days After a Recording of 5% Gain in Body Weight|For each monthly observation: The proportion of patients at each site with weight gain that have guideline-recommended weight management (e.g., counseling about diet or exercise, referral to weight management program) initiated within 30 days.|Change in weight management rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases|All patients meeting inclusion/exclusion criteria|||Participants|||Count of Participants
2628679|NCT01875861|Secondary|Change in Site-level Rates of Weight Monitoring at Follow-up (From 31-120 Days After a New Antipsychotic Prescription)|For each monthly observation: The proportion of patients at each site due for weight monitoring at follow-up who have weight recorded in the electronic health record.|Change in monitoring rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases|All patients meeting inclusion/exclusion criteria|||Participants|||Count of Participants
2628680|NCT01875861|Primary|Change in Site-level Rates of Weight Monitoring at Baseline (Within 30 Days of a New Antipsychotic Prescription)|For each monthly observation: The proportion of patients at each site due for weight monitoring at baseline who have weight recorded in the electronic health record.|Change in monitoring rates will be measured monthly through 6-month pre-implementation, implementation, and sustainability phases|"All patients who met inclusion criteria for this measure. Note that total for Outcome 1 is less than overall total N because patients were included for each measure independently if they met criteria any time in the 6-month implementation phases. Slightly more patients met criteria for the follow-up monitoring measures than baseline monitoring."|||Participants|||Count of Participants
2628681|NCT01875848|Secondary|Patient Global Impression of Change (PGIC)|"The Patient Global Impression of Change Scale (PGIC) is one question capturing the individual's overall perception of efficacy of treatment in a clinical trial. It uses verbal outcome categories on a 7-point scale with very much worse and very much better as anchors and no change in the middle. The verbal categories were coded on a scale with -3 very much worse,+3 very much better, and 0 same. To calculate the mean and standard deviation of each group (Bup/Opioid Increase) we took the sum of each participants final PGIC score and divided by the total number of participants."|12 wks|This group of subjects consisted of five males. One Buprenorphine subject aged-72 and four Opioid Dose Escalation subjects aged- 66,77,78,and 58.|||units on a scale||Standard Deviation|Mean
2628682|NCT01875848|Primary|Change in Numeric Rating Scale of Pain Severity|Validated 11 pt scale 0-10, to evaluate a patient's current severity of pain. A rating of 0 indicates no pain while 10 indicates the worst pain imaginable. A score of 4 or above is considered a clinically significant pain level according to VHA treatment guidelines.|Baseline and 12 wks|This group of subjects consisted of five males. One Buprenorphine subject aged-72 and four Opioid Dose Escalation subjects aged- 66,77,78,and 58.|||units on a scale||Standard Deviation|Mean
2628683|NCT01875783|Secondary|Rates of Retinal Treatment Over 1 Year for Patients With DME|Percentage of participants who are referred by OCT guided algorithm to a retina specialist who receive treatment for DME over the course of 9 months follow-up by retina specialist|9 months|This is the subgroup of participants who were referred for retina care by the OCT guided referral algorithm.|||Participants|||Count of Participants
2628684|NCT01875783|Secondary|Rates of Retinal Treatment for Patients With DME|Percentage of participants are referred by OCT-guided algorithm who are confirmed to have vision threatening retinopathy at first visit with retina specialist after study enrollment|One month|This is the subgroup of participants who were referred for retinal care by the OCT guided referral algorithm|||Participants|||Count of Participants
2628685|NCT01875783|Secondary|Retinal Referral Rates for Patients With DME|Count of eyes that are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm|Baseline visit||||eyes|eyes||Count of Units
2628686|NCT01875783|Primary|Rates of Retina Care Referral for Patients With Diabetic Macular Edema|Percentage of participants who are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm|Baseline visit||||Participants|||Count of Participants
2628687|NCT01875731|Secondary|Treatment Failure in Each Group|Number of participants with persistence of fever after 2 days, or tachypnea or diminishing in respiratory rate less than 5 bpm. after 2 days, or signs of severe pneumonia or requiring or changing antibiotics at any time.|1, 2, 5, 7 and 10 days from baseline||||participants|||Number
2628688|NCT01875731|Primary|Use of Antibiotics in Each Group|Number of participants with use of any antibiotic, at any time after diagnosis|At day 7 from baseline||||participants|||Number
2628689|NCT01875510|Primary|Number of Participants With Retinopathy of Prematurity|The number of Participants with Retinopathy of Prematurity will be defined.|Corrected age 32 weeks or postnatal 28th day||||participants|||Number
2628690|NCT01875471|Primary|Subjective Ease of Lens Removal|After 1-week of lens wear, each subject was asked to rate a question, 'Ease of taking the lenses off of your eyes', using 5-point scale (1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor).|Day 7||||participants|||Number
2628691|NCT01875445|Secondary|The Massachusetts General Hospital (MGH) Hairpulling Scale|The entire study for an individual subject will last 10 weeks. Every 2 weeks the subject will take the MGH Hairpulling Scale for the duration of the 10 weeks, baseline and final visits will be use for general final outcome assessment. The scale itself asses severity of hair pulling.|Once every two weeks for the 10 weeks of the study|Last observation carried forwards for general averages.|||units on a scale||Standard Deviation|Mean
2628692|NCT01875445|Primary|The National Institute of Mental Health Trichotillomania Symptom Severity Scale (NIMH-TSS)|The entire study for an individual subject will last 10 weeks. Every 2 weeks the subject will take the NIMH-TSS for the duration of the 10 weeks, but only baseline and final values will be used for general final outcome assessment. The scale itself asses severity of hair pulling.|Once every two weeks for the 10 weeks of the study|Last observation carried forward for general means.|||units on a scale||Standard Deviation|Mean
2628693|NCT01875237|Other Pre-specified|To Determine the Change in Patient-reported Outcomes|To determine the change in patient-reported outcomes from enrollment to day 56 post administration of AP1903, through the patient quality of life survey.|Day 56 post administration of AP1903|Participant completed quality of life surveys but data was not analyzed to provide outcome measure.||||||
2654529|NCT01634854|Secondary|Neonatal Weight at Delivery|Neonatal Weight|Immediately following delivery||||grams||Inter-Quartile Range|Median
2628698|NCT01875237|Secondary|To Assess the Proportions of GvHD Response Post-administration of AP1903.|To assess the proportions of GvHD complete response (CR), partial response (PR), mixed response, no response, and progression among surviving patients at Day 3, 7, 14, 28, and 56 post-administration of AP1903.|Day 3, 7, 14, 28, and 56 post-administration of AP1903|Patient who received DLI|||Participants|||Count of Participants
2628699|NCT01875237|Secondary|To Assess the Proportion of Patients Developing Grade I-IV Acute GvHD|To assess the proportion of patients developing grade I-IV acute GvHD by Day 28, 56, and 180 post DLI.|Day 28, 56, and 180 post DLI.|all patients who received DLI|||Participants|||Count of Participants
2628700|NCT01875237|Secondary|To Assess the Incidence of Epstein-Barr Virus -PTLD or EBV Reactivation Requiring Therapy Post DLI.|To assess the incidence of Epstein-Barr virus (EBV)-associated lymphoproliferative disorder or EBV reactivation requiring therapy post DLI.|1 year|all patients who received DLI|||Participants|||Count of Participants
2628701|NCT01875237|Secondary|Number of Participants Assessed Post Donor Lymphocyte Infusion (DLI): Disease-free Survival & Non-relapse Mortality, Chimerism and GVHD.|Participants to assess at 6 months post donor lymphocyte infusion (DLI): disease-free survival & non-relapse mortality, chimerism and GVHD|6 months|Transplant only participants did not receive DLI.|||Participants|||Count of Participants
2628702|NCT01875237|Primary|To Evaluate the Safety of Donor Lymphocyte Infusion Followed by Dimerizer Drug, AP1903 by Number of Participants With Adverse Events.|To evaluate the safety of the infusion of inducible caspase 9 (BPZ-1001) modified T-cells followed by dimerizer drug, AP1903. Safety evaluated by number of participants with Adverse events.|up to 3.5 years|Participant who received Donor Lymphocyte infusion and AP 1903|||Participants|||Count of Participants
2628703|NCT01875185|Secondary|Relative Change of UTXB2 in pg/mg Creatinine in Response to Aspirin|Comparing premenopausal women to postmenopausal women, the level of urinary thromboxane (pg/mg creatinine) in response to aspirin|change from baseline to 7 days|No data was collected for this outcome measure, as the study was terminated prematurely||||||
2628704|NCT01875185|Secondary|Level of UTXB2 in pg/mg Creatinine|Comparing premenopausal women to postmenopausal women, the level of urinary thromboxane (pg/mg creatinine) in response to aspirin|baseline|Data was only collected at baseline. The study was terminated prior to initiation of intervention (Aspirin) and therefore no follow-up data was collected to calculate the change from baseline.|||pg/mg||Inter-Quartile Range|Median
2628705|NCT01875185|Primary|The Change in the Level of UTXB2 in pg/mg Creatinine: Estrogen and Progesterone|Measurement of urinary thromboxane (pg/mg creatinine) in relation to estrogen to progesterone level in premenopausal women on aspirin for 7 days.|baseline to 7 days|Data was only collected at baseline. The study was terminated prior to obtaining study data.||||||
2628706|NCT01875185|Primary|Level of Urinary Thromboxane (UTXB2) in pg/mg Creatinine|Urinary thromboxane (pg/mg creatinine) will be measured in premenopausal and postmenopausal women at baseline and then after taking on aspirin for 7 days.|Baseline|Data was only collected at baseline. The study was terminated prior to initiation of intervention (Aspirin) and therefore no follow-up data was collected to calculate the change from baseline.|||pg/mg||Inter-Quartile Range|Median
2628707|NCT01875159|Primary|Number of Seconds of Intermittent Hypoxia Per Hour|Number of seconds of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation|35, 36, 37, 38 weeks postmenstrual age|Intention to treat|||seconds per hour||Standard Deviation|Mean
2628708|NCT01875159|Primary|Episodes of Intermittent Hypoxia Per Hour|Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation|35, 36, 37, 38 weeks postmenstrual age|Intention to treat|||Events per hour||Standard Deviation|Mean
2628709|NCT01874951|Secondary|Remission Rate|Remission is defined as a final HAM-D-17 score of 7 or less. Remission rate is the percent of patients who attain this threshold score.|Remission rate at 3 weeks.|Study completers.|||Participants|||Count of Participants
2628710|NCT01874951|Secondary|Response Rate|Response is defined as an improvement in HAM-D-17 score of greater than or equal to 50% compared to baseline score. Response rate is the percent of patients who attain this threshold degree of improvement.|Response rate after 3 weeks|Study completers.|||Participants|||Count of Participants
2628711|NCT01874951|Secondary|Final CGI-I Score|Clinical Global Improvement-Improvement Scale. The CGI-I scale is a one item scale that measures overall change in patient's global condition compared to when they were entered into the study. The scale is graded from 1-7, where 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Thus higher scores indicate greater worsening, and lower scores indicate greater improvement. The lowest possible score (indicating maximum improvement) is 1, and the highest possible score (indicating greatest worsening) is 7.|From baseline to week 3|Study completers.|||units on a scale||Standard Deviation|Mean
2628712|NCT01874951|Secondary|Change in CGI-S Total Score|Clinical Global Improvement-Severity Scale. The CGI-S score is a one-item scale that measures severity of depression, scored from 1-7, where 1 = no depression is present, 2 = borderline depression, 3 = mild depression, 4 = moderate depression, 5 = marked depression, 6 = severe depression, and 7 = among the most extremely depressed patient. Thus higher scores indicate greater depressive severity. The change in CGI-S score can represent a drop from 7 (maximum severity) to 1 (no depression) or -6. There is no minimum CGI-S score required for admission, but a minimum score of 18 on the HAMD17 corresponds to approximately a score of 4 on the CGI-S. Thus a maximum worsening would be from 4 to 7, or +3.|Change from baseline to week 3|Study completers.|||units on a scale||Standard Deviation|Mean
2628713|NCT01874951|Secondary|Change in MADRS-15 Total Score|Montgomery-Asberg Depression Rating Scale- 15 item. The change in scores depends on the difference between the initial (baseline) score and the final score at the conclusion of the double blind treatment period. There is no formal range of score changes, since they depend on the initial and final score. A negative score represents a lowering in the score from baseline to end (improvement), and a positive score indicates an increase in score from baseline to end (worsening). A zero score would indicate no change. In theory, the maximum drop in score would be from 90 to zero, or -90. There is no minimum score on the MADRS-15 required for study entry, since the HAMD-17 was the sole entry criteria. However, a score of 18 on the HAMD17 corresponds to approximately a score of 21 on the MADRS-10. A maximum estimated increase would thus be from 21 to 90, or +69.|Change from baseline to week 3|Study completers.|||units on a scale||Standard Deviation|Mean
2628714|NCT01874951|Secondary|Change in MADRS-10 Total Score|Montgomery-Asberg Depression Rating Scale- 10 item. The change in scores depends on the difference between the initial (baseline) score and the final score at the conclusion of the double blind treatment period. There is no formal range of score changes, since they depend on the initial and final score. A negative score represents a lowering in the score from baseline to end (improvement), and a positive score indicates an increase in score from baseline to end (worsening). A zero score would indicate no change. In theory, the maximum drop in score would be from 60 to zero, or -60. There is no minimum score on the MADRS-10 required for study entry, since the HAMD-17 was the sole entry criteria. However, a score of 18 on the HAMD17 corresponds to approximately a score of 21 on the MADRS-10. A maximum estimated increase would thus be from 21 to 60, or +39.|Change from baseline to week 3|Study completers.|||units on a scale||Standard Deviation|Mean
2628715|NCT01874951|Secondary|Change in HAM-D28 Total Score|Hamilton Depression Scale-28 item. The change in scores depends on the difference between the initial (baseline) score and the final score at the conclusion of the double blind treatment period. There is no formal range of score changes, since they depend on the initial and final score. A negative score represents a lowering in the score from baseline to end (improvement), and a positive score indicates an increase in score from baseline to end (worsening). A zero score would indicate no change. In theory, the maximum drop in score would be from 81 to zero, or -81. A maximum increase would be from 18 (the minimum score required for admission) to 81, or +63.|Change from baseline to week 3|Study subjects who completed the protocol|||units on a scale||Standard Deviation|Mean
2628716|NCT01874951|Primary|Change in HAM-D-17 Total Score|Hamilton Depression Scale-17 (HAM-D-17) item. The change in scores depends on the difference between the initial (baseline) score and the final score at the conclusion of the double blind treatment period. There is no formal range of score changes, since they depend on the initial and final score. A negative score represents a lowering in the score from baseline to end (improvement), and a positive score indicates an increase in score from baseline to end (worsening). A zero score would indicate no change. In theory, the maximum drop in score would be from 52 to zero, or -52. A maximum increase would be from 18 (the minimum score required for admission) to 52, or +34.|Change from baseline to week 3|Study completers.|||units on a scale||Standard Deviation|Mean
2628717|NCT01874756|Primary|Cortical Target Engagement|To determine if LY500307 demonstrates cortical target engagement as assessed by changes in the N-back in frontal-parietal regions during the MRI.|Baseline, 8 weeks||||beta coefficient||Standard Deviation|Mean
2628718|NCT01874756|Primary|Number of Subjects With QTc Prolongation|Number of subjects with QTc prolongation, as defined as any subject with a change from baseline of 60 msec or greater during the active treatment phases|Week 4, Week 8||||participants|||Number
2628719|NCT01874756|Primary|Number of Subjects With Total Testosterone Reduction|Number of subjects with total testosterone reduction, as defined as a decrease in total testosterone plasma concentrations of 50% from baseline for two consecutive post-randomization values|week 2, week 4, week 8||||participants|||Number
2628720|NCT01874756|Primary|Verbal Learning Composite Score Changes|"Verbal learning (composite score of the Hopkins Verbal Learning Test-Revised (HVLT-R)). The HVLT-R has 3 trials in which a subject recalls has many words from a list of 12 as they can. The total number recalled for each trial is summed and the score range is between 0-36. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance.~The verbal learning composite score is calculated by using the HVLT-R tscore, a higher tscore reflects better performance."|Baseline, week 2, week 4, week 6, week 8||||score on a scale||Standard Deviation|Mean
2628721|NCT01874756|Primary|Working Memory Composite Score Changes|"Working memory (composite score of the Wechsler Memory Scale-III: Spatial Span (WMS) and Letter Number Span (LNS) tests). WMS has 2 sections in which a subject recalls increasingly difficult sequences. The total raw score range for both sections is 0-32. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance.~LNS consists of 24 increasingly difficult sequences of letters and numbers that a subject is to recall and repeat back in Numeric-Alpha sequential order. The total raw score range is 0-24. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance.~The Working Memory composite score is calculated by summing the WMS and LNS tscores, ranging from 0-200, a higher tscore reflects better performance."|Baseline, week 2, week 4, week 6, week 8||||score on a scale||Standard Deviation|Mean
2628722|NCT01874756|Primary|Negative Symptom Changes - Negative Symptom Assessment Scale - 16-item (NSA-16) Total Score|"The Negative Symptom Assessment Scale - 16-item (NSA-16) is used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale rates subjects on 16 anchors, is a semi-structured, clinical interview, and each item is rated from 1 to 6. The total score is the sum of the 16 specific items and ranges from 16 to 96; a higher score indicates greater severity of illness. In addition, there is a global rating that represents the overall assessment of a subject's negative symptoms. The rating should not be an average of any particular behavior, but a gestalt of everything observed in the interview."|Baseline, week 2, week 4, week 6, week 8||||score on a scale||Standard Deviation|Mean
2628723|NCT01874665|Secondary|Cmax, SS: Maximum Observed Plasma Concentration at Steady State for Ponatinib||Pre-dose and at multiple timepoints (up to 1 month) post-dose|Data was not collected for Cmax,ss, since outcome measure was not planned to be analyzed.||||||
2628724|NCT01874665|Secondary|Number of Participants Reporting One or More TEAEs and Serious Adverse Event (SAE)||From date of enrollment until the End-of-Treatment, assessed up to 3 years|The ITT population included all participants who received any dose of ponatinib in the study.|||Participants|||Count of Participants
2628725|NCT01874665|Secondary|Number of Participants With TEAEs Related to Echocardiography Parameter||From date of enrollment until the End-of-Treatment, assessed up to 3 years|The ITT population included all participants who received any dose of ponatinib in the study.|||Participants|||Count of Participants
2628726|NCT01874665|Secondary|Number of Participants With TEAEs Related to Electrocardiogram (ECG) Findings||From date of enrollment until the End-of-Treatment, assessed up to 3 years|The ITT population included all participants who received any dose of ponatinib in the study.|||Participants|||Count of Participants
2639065|NCT01768013|Primary|Pharmacokinetic: Cmax of Calcipotriol|The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined|Day 1||||pg/mL||Standard Deviation|Mean
2628727|NCT01874665|Secondary|Number of Participants With Worst Shift From Baseline Values to Post-baseline Values in Laboratory Parameters||From date of enrollment until the End-of-Treatment, assessed up to 3 years|The ITT population included all participants who received any dose of ponatinib in the study.|||Participants|||Count of Participants
2628728|NCT01874665|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Sign Measurements||From date of enrollment until the End-of-Treatment, assessed up to 3 years|The ITT population included all participants who received any dose of ponatinib in the study.|||Participants|||Count of Participants
2628729|NCT01874665|Secondary|Number of Participants With Physical Examination||From date of enrollment until the End-of-Treatment, assessed up to 3 years|The ITT population included all participants who received any dose of ponatinib in the study.|||Participants|||Count of Participants
2628730|NCT01874665|Secondary|Overall Survival (OS)|OS is defined as the time interval between the first dose of study drug to death due to any cause. Overall survival was analyzed using the Kaplan-Meier method.|From first dose of drug until the end of the study or death, whichever came first, assessed up to 3 years|The ITT population included all participants who received any dose of ponatinib in the study.|||days||95% Confidence Interval|Median
2628731|NCT01874665|Secondary|Percentage of Participants With Objective Response Rate (ORR)|ORR is defined as the composite of CR and PR per Response Evaluation Criteria in RECIST 1.1, assessed for each cohort and in the total participant population. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions.|From date of enrollment until discontinuation or the end of the study, whichever came first, assessed up to 3 years|The ITT population included all participants who received any dose of ponatinib in the study. The ITT population where data at specified time points was available.|||percentage of participants||95% Confidence Interval|Number
2628732|NCT01874665|Secondary|Progression-free Survival (PFS)|PFS is defined as the duration of time from start of study drug administration to time of objective disease progression or death due to any cause, whichever may come first. To assess PFS in each cohort and in the total participant population.|From date of enrollment until the end of the study or disease progression or death due to any cause, whichever came first, assessed up to 3 years|The ITT population included all participants who received any dose of ponatinib in the study.|||days||95% Confidence Interval|Median
2628733|NCT01874665|Secondary|Clinical Benefit Rate (CBR) in Cohort B|To assess clinical benefit rate in participants with GIST that lacks KIT exon 11 mutations (Cohort B) and in the total participant population. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 millimeter [mm]). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as not qualifying for CR, PR, PD.|16 weeks after first dose|The ITT population included all participants who received any dose of ponatinib in the study.|||percentage (%) of participants||95% Confidence Interval|Number
2628734|NCT01874665|Primary|Clinical Benefit Rate (CBR) in Cohort A|To assess clinical benefit rate in participants with KIT exon 11-mutant GIST.It is defined as the composite of complete response(CR),partial response(PR),and stable disease(SD) lasting >=16 weeks per modified Response Evaluation Criteria In Solid Tumors(RECIST) 1.1 as a measure of disease control.CR is complete disappearance of all target lesions and non-target disease, with the exception of nodal disease.All nodes, both target and non-target, must decrease to normal (short axis <10millimeter [mm]).No new lesions.PR is >=30% decrease under baseline of the sum of diameters of all target lesions.The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.No unequivocal progression of non-target disease.No new lesions.SD is not qualifying for CR,PR,Progressive Disease(PD).PD is >=20% increase from the smallest prior sum of the longest diameter(SLD)and with >=5mm absolute increase, or appearance of a new lesion.|16 weeks after first dose|The ITT population included all participants who received any dose of ponatinib in the study. The ITT population where data at specified time points was available.|||percentage (%) of participants||95% Confidence Interval|Number
2628735|NCT01874535|Primary|The Rates of Complete Symptom Relief|Rate of complete symptom relief (CSR) at the end of initial treatment phase|at the 20 weeks after the end of initial treatment.||||participants|||Number
2628736|NCT01874353|Secondary|To Determine the Exposure to Olaparib by Pharmacokinetic Analysis|To determine the exposure to olaparib in patients receiving olaparib maintenance monotherapy|Pharmacokinetics sampling to be performed in a subset of patients. Sampling times: Day 1 pre-dose & 1 hour; Day 15 pre-dose & 1 hour; Day 29 pre-dose|Pharmacokinetic (PK) Analysis Set - all patients who receive study treatment as per protocol, do not violate or deviate from the protocol in ways that would significantly affect the PK analyses and have valid PK data|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2628737|NCT01874353|Secondary|Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS.|To assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).|Radiologic scans performed at baseline then every ~12 weeks for the first 72 weeks, then every ~24 weeks thereafter, assessed until disease progression.|FAS consisting of all patients who are randomized and confirmed as Myriad gBRCAm|||Months||95% Confidence Interval|Median
2628738|NCT01874353|Secondary|Efficacy of Olaparib by Time From Randomization to Study Treatment Discontinuation or Death (TDT).|To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to study treatment discontinuation or death (TDT).|Time elapsed from randomization to study treatment discontinuation or death. Assessed up to a maximum of 36 months. A further analysis of TDT will be performed at approximately 60% OS maturity.|FAS consisting of all patients who are randomized|||Months||95% Confidence Interval|Median
2628739|NCT01874353|Secondary|Efficacy of Olaparib by Time to Second Subsequent Therapy or Death (TSST).|To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to second subsequent therapy or death (TSST).|Time elapsed from randomization to second subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed up to a maximum of 36 months. A further analysis of TSST will be performed at approximately 60% OS maturity.|FAS consisting of all patients who are randomized|||Months||95% Confidence Interval|Median
2628740|NCT01874353|Secondary|Efficacy of Olaparib by Time to First Subsequent Therapy or Death (TFST).|To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization to first subsequent therapy or death (TFST).|Time elapsed from randomization to first subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed up to a maximum of 36 months. A further analysis of TFST will be performed at approximately 60% OS maturity.|FAS consisting of all patients who are randomised|||Months||95% Confidence Interval|Median
2628741|NCT01874353|Secondary|Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)|To compare the effects of olaparib maintenance monotherapy compared to placebo on Health-related Quality of Life (HRQoL) as assessed by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.|Questionnaires completed by patient at baseline, Day 29 and then every 12 weeks for 12 months.|FAS consisting of all patients who are randomized with a baseline and post baseline TOI score available|||Change in TOI over 12 months||95% Confidence Interval|Least Squares Mean
2628742|NCT01874353|Secondary|Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression|To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete response or partial response following first line platinum based chemotherapy by assessment of time from randomization up to second progression|Radiologic scans performed at baseline then every 12 weeks for 72 weeks, then every 24 weeks thereafter until first progression. Disease then assessed per local practice every 12 weeks until second progression. Assessed up to a maximum of 36 months.|FAS consisting of all patients who are randomized|||Months||95% Confidence Interval|Median
2628743|NCT01874353|Secondary|Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death|To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of time to earliest progression by RECIST or CA-125 or death.|CA-125 performed at baseline then every 4 weeks. Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks until objective radiological disease progression. Assessed up to a maximum of 36 months.|FAS consisting of all patients who are randomized|||Months||95% Confidence Interval|Median
2628744|NCT01874353|Secondary|Efficacy in Patients Following Platinum Based Chemotherapy by Assessment of Overall Survival|To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy by assessment of overall survival (OS).|Survival assessed every 4 weeks until treatment discontinues, then every 12 weeks (assessed up to a maximum of 36 months). Analyzed at the time of the primary analysis of PFS and a further analysis of OS will be performed at approximately 60% maturity.|FAS consisting of all patients who are randomized|||Months||95% Confidence Interval|Median
2628745|NCT01874353|Primary|Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)|To determine the efficacy by progression free survival (PFS) (using investigator assessment according to modified Response Evaluation Criteria In Solid Tumours (RECIST 1.1)) of olaparib maintenance monotherapy compared to placebo in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.|Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 36 months.|Full Analysis Set (FAS) consisting of all patients who are randomized|||Months||95% Confidence Interval|Median
2628746|NCT01874340|Secondary|Number of Particpants With Adverse Events as a Measure of Safety and Tolerability|Number of particpants with Adverse events as a measure of safety and tolerability|6 months|The safety set consists of all subjects who received at least one dose of study medication. Subjects will be analyzed according to the treatment received.|||Participants|||Number
2628747|NCT01874340|Secondary|Change in Total Volume of T2-weighted Lesions|Due to early termination this trial was not powered for efficacy no statistical analysis was performed|Baseline, Month 6|Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.||||||
2628748|NCT01874340|Secondary|Combined Unique Active Lesions (CUAL)|Due to early termination this trial was not powered for efficacy no statistical analysis was performed|Months 3, 4, 5, 6|Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.||||||
2628749|NCT01874340|Secondary|Annualized Relapse Rate|Due to early termination this trial was not powered for efficacy no statistical analysis was performed|6 Months|Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.||||||
2628750|NCT01874340|Primary|Cumulative Number of New Gadolinium [Gd]-Enhancing T1-weighted Lesions|Due to early termination this trial was not powered for efficacy no statistical analysis was performed|Months 3, 4, 5, 6|Due to the early termination of the study and just one patient completing treatment as planned, no statistical analyses could be performed for the efficacy endpoints defined in the protocol.||||||
2628751|NCT01874275|Other Pre-specified|Sleep Arousal Statistics Index at 365 Days|Sleep / Arousal Statistics Index (ASI) description: Sleep Studies were obtained twice before beginning the study. The second sleep study data was used as baseline. A follow up sleep study was obtained after 6 months (180 days) of Active or Placebo VECTTOR treatment. Sleep, breathing, arousal(s), and limb movements were scored manually according to guidelines of the American Academy of Sleep Medicine. The efficacy of the outcome measure of ASI is demonstrated by a decrease in the value between Baseline and 180 days. The ASI is measured by the number of times sleep is interrupted per hour. Lower ASI values/numbers indicate improved sleep quality.|Baseline to 365 days||2015-03-31|03/2015||||
2628752|NCT01874275|Secondary|Percent Change in Muscle Strength|Muscle strength testing (Wireless Tracker system) - All muscle strength testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in muscle strength. JTech computerized testing system determined the muscle strength by radio signals from a strain gauge measuring strength of the participant's muscles. 44 separate tests were performed for muscle strength for each participant at each time interval. Efficacy is defined as an increase in the strength measurement (pounds) from Baseline to 365 days.|Baseline to 365 days||||percentage of change||Standard Deviation|Mean
2628753|NCT01874275|Secondary|Percent Change in Percent Range of Motion From Baseline to 365 Days|Range of Motion (ROM) testing (Wireless Tracker System) - All muscle and joint testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in joint Range of Motion. JTech computerized testing system determined the joint range of motion by radio signals from a goniometer measuring movement of the participants' joints. 44 separate tests were performed for Range of Motion for each participant at each time interval. The results from the range of motion tests were averaged the percent change from baseline to 365 days. Efficacy is defined as an increase in range of motion.|Baseline to 365 days||||percentage of change||Standard Deviation|Mean
2628754|NCT01874275|Other Pre-specified|Percent Change in Sleep Quality Arousal Statistics Index (ASI) From Baseline to 180 Days|Sleep / Arousal Statistics Index (ASI) description: Sleep Studies were obtained twice before beginning the study. The second sleep study data was used as baseline. A follow up sleep study was obtained after 6 months (180 days) of Active or Placebo VECTTOR treatment. Sleep, breathing, arousal(s), and limb movements were scored manually according to guidelines of the American Academy of Sleep Medicine. The efficacy of the outcome measure of ASI is demonstrated by a percent improvement between Baseline and 180 days. The ASI is measured by the number of times sleep is interrupted per hour.|Baseline to 180 days||||percentage of change||Standard Deviation|Mean
2628755|NCT01874275|Secondary|Percent Change in Muscle Strength|Muscle strength testing (Wireless Tracker system) - All muscle strength testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, and 180 days to determine changes in muscle strength. JTech computerized testing system determined the muscle strength by radio signals from a strain gauge measuring strength of the participant's muscles. 44 separate tests were performed for muscle strength for each participant at each time interval. Efficacy is defined as an increase in the strength measurement (pounds) from Baseline to 180 days.|Baseline to 180 days||||percentage of change||Standard Deviation|Mean
2628756|NCT01874275|Primary|Percent Change in Range of Motion From Baseline to 180 Days|Range of Motion (ROM) testing (Wireless Tracker System) - All muscle and joint testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90 and 180 days to determine changes in joint Range of Motion. JTech computerized testing system determined the joint range of motion by radio signals from a goniometer measuring movement of the participants' joints. 44 separate tests were performed for Range of Motion for each participant at each time interval. The results from the range of motion tests were averaged the percent change from baseline to 180 days. Efficacy is defined as an increase in range of motion.|Baseline to 180 days||||percentage of change||Standard Deviation|Mean
2628757|NCT01874262|Primary|Non-adherence Score|The primary composite endpoint was defined as a non-adherence score based on the combination of adherence failure events and treatment gaps. Adherence failure events were defined as 2 missed doses during an observation cycle of up to 7 days. The first registered missed dose of ticagrelor in the e-diary initiated an observation cycle of 1 week. If a second missed dose was registered during the week, this was considered an adherence failure event. The third missed dose initiated a new observation cycle, and the process restarted. If the second missed dose was registered after more than 1 week, this was not defined as an adherence failure event, but initiated a new observation cycle. Treatment gaps were defined as patient reported gaps of 4 consecutive doses.|6 months||||Non-adherence score||Standard Deviation|Mean
2628758|NCT01874145|Secondary|Change From Start of Extension Period to Month 8 (and to Endpoint Visit) in in the Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Satisfaction Score|"The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on global satisfaction, items 7-9. TSQM-9 participant perception of satisfaction score was calculated as: ([sum(Item 7 to Item 9) - 3] divided by 14) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement satisfaction with medication.~The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period."|Month 4 (baseline for extension period), Month 8, endpoint visit|Full analysis set Extension Period|||units on a scale||Standard Deviation|Mean
2628759|NCT01874145|Primary|Injection-Related Adverse Events in the Extension Period|Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria).|Month 5 up to Month 10|ITT extension analysis set of participants who had at least one injection-related AE|||events|||Number
2629191|NCT01868425|Secondary|Impact of Block Characteristics on Pain Control||Up to 24 hours following surgery|This data was not collected. All participants had a femoral nerve block. The quality of this block was not assessed.||||||
2628760|NCT01874145|Secondary|Change From Start of Extension Period to Month 8 (and to Endpoint Visit) in in the Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Convenience Score|"The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on convenience items 4-6, with each question graded on a scale of 1 (extreme dissatisfaction) to 7 (extreme satisfaction). TSQM-9 participant perception of convenience score was calculated as: ([sum (Item 4 to Item 6) - 3] divided by 18) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement.~The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period."|Month 4 (baseline for extension period), Month 8, endpoint visit|Full analysis set Extension Period|||units on a scale||Standard Deviation|Mean
2628761|NCT01874145|Secondary|Change From Start of Extension Period (Month 4) to Month 8 (and to Endpoint Visit) in the Participant-Reported Impact on Psychological Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO)|"The psychological wellbeing assessment portion of the MSIS-29 is comprised of 9 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 9-45. Negative change from baseline scores indicate improvement in psychological wellbeing.~The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period."|Month 4 (baseline for extension period), Month 8, endpoint visit|Full analysis set Extension Period|||units on a scale||Standard Deviation|Mean
2628762|NCT01874145|Secondary|Change From Start of Extension Period (Month 4) to Month 8 (and to Endpoint Visit) in the Participant-Reported Impact on Physical Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO)|"The physical wellbeing assessment portion of the MSIS-29 is comprised of 20 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 20-100. Negative change from baseline scores indicate improvement in physical wellbeing.~The Extension Period endpoint visit was defined as the last observed post-baseline data of the Extension Period."|Month 4 (baseline for extension period), Month 8, endpoint visit|Full analysis set Extension Period|||units on a scale||Standard Deviation|Mean
2628763|NCT01874145|Secondary|Injection Site Reaction Events in the Extension Period|"This outcome includes injection-related adverse events referring to all local injection site reactions (ISR).~For cases in which more than 1 ISR adverse event started on the same date for the same patient, these were counted as 1 ISR adverse event for that patient."|Month 5 up to Month 10|ITT extension analysis set of participants who had injection site reaction AEs.|||events|||Number
2628764|NCT01874145|Secondary|Injection Site Reaction Event Rate Per Year in the Extension Period|"This outcome includes injection-related adverse events referring to all local injection site reactions (ISR). Rate was calculated as # ISR events/the total exposure to study drug in years.~For cases in which more than 1 ISR adverse event started on the same date for the same patient, these were counted as 1 ISR adverse event for that patient."|Month 5 up to Month 10|ITT extension analysis set of participants who had injection site reaction AEs.|||events per year|||Number
2628765|NCT01874145|Secondary|Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Satisfaction Score in the Core Period|"The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on global satisfaction, items 7-9. TSQM-9 participant perception of satisfaction score was calculated as: ([sum(Item 7 to Item 9) - 3] divided by 14) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement satisfaction with medication.~The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline TSQM convenience score, treatment group, month, treatment by month interaction."|Month 0 (baseline), Months 1, 2 4 (or early termination visit)|Full analysis set. Some scales/forms were not completed (including partially completed) and therefore not included in this analysis.|||units on a scale||Standard Error|Mean
2628766|NCT01874145|Secondary|Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Convenience Score in the Core Period|"The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. This outcome focuses on convenience items 4-6, with each question graded on a scale of 1 (extreme dissatisfaction) to 7 (extreme satisfaction). TSQM-9 participant perception of convenience score was calculated as: ([sum (Item 4 to Item 6) - 3] divided by 18) * 100. The full range was -100 to 100, with positive change from baseline indicating improvement.~The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline TSQM convenience score, treatment group, month, treatment by month interaction."|Month 0 (baseline), Months 1, 2 4 (or early termination visit)|Full analysis set. Some scales/forms were not completed (including partially completed) and therefore not included in this analysis.|||units on a scale||Standard Error|Mean
2628767|NCT01874145|Secondary|Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Impact on Psychological Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO) in the Core Period|"The psychological wellbeing assessment portion of the MSIS-29 is comprised of 9 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 9-45. Negative change from baseline scores indicate improvement in psychological wellbeing over time.~The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline MSIS-29 psychological score, treatment group, month, treatment by month interaction."|Month 0 (baseline), Months 1, 2 4 (or early termination visit)|Full analysis set. Some scales/forms were not completed (including partially completed) and therefore not included in this analysis.|||units on a scale||Standard Error|Mean
2628768|NCT01874145|Primary|Injection-Related Adverse Event Rate Per Year in the Extension Period|"Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria). Rate was calculated as # IR events/the total exposure to study drug in years.~For cases in which more than 1 IR adverse event started on the same date for the same patient, these were counted as 1 IR adverse event for that patient."|Month 5 up to Month 10|ITT extension analysis set of participants who had at least one injection-related AE|||events per year|||Number
2628769|NCT01874145|Secondary|Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Impact on Physical Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO) in the Core Period|"The physical wellbeing assessment portion of the MSIS-29 is comprised of 20 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 20-100. Negative change from baseline scores indicate improvement in physical wellbeing over time.~The estimated change from baseline to month 4 adjusted for months 1 and 2 was generated using a mixed model repeated measures analysis adjusted for baseline MSIS-29 physical score, treatment group, month, treatment by month interaction."|Month 0 (baseline), Months 1, 2, 4 (or early termination visit)|Full analysis set. Some scales/forms were not completed (including partially completed) and therefore not included in this analysis.|||units on a scale||Standard Error|Mean
2628770|NCT01874145|Secondary|Adjusted Mean Estimates for Injection Site Reaction Event Rate Per Year in the Core Period|"This outcome includes injection-related adverse events referring to all local injection site reactions (ISR). Rate was calculated as # ISR events/the total exposure to study drug in years.~For cases in which more than 1 ISR adverse event started on the same date for the same patient, these were counted as 1 ISR adverse event for that patient.~Parameter statistics were generated from a Poisson regression model with natural log of treatment duration (years) as an offset variable, and adjusted for baseline EDSS score, treatment group, age, sex, number of relapses in the 2 years prior to screening, in which a contrast comparing treatment groups were constructed. Adjusted mean estimates were adjusted estimates of event rates within treatment group."|Day 1 to Month 4|Safety analysis set|||events per year||Standard Error|Mean
2628771|NCT01874145|Other Pre-specified|Percentage of Participants With Adverse Events Other Than Injection Related Reactions During the Core Period and the Extension Period|An adverse event was defined in the protocol as any untoward medical occurrence in a patient that developed or worsened in severity during the conduct of the clinical study of a pharmaceutical product and did not necessarily have a causal relationship to the study drug. This outcome summarizes the % of participants who had AEs other than injection related reactions. Injection-related (IR) adverse events referring to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria).|Day 1 to Month 4 (core period); Month 5 to 10 (extension period)|Safety analysis set|||percentage of participants|||Number
2628772|NCT01874145|Primary|Adjusted Mean Estimates for Injection-Related Adverse Event Rate Per Year in the Core Period|"Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria). Rate was calculated as # IR events/the total exposure to study drug in years.~For cases in which more than 1 IR adverse event started on the same date for the same patient, these were counted as 1 IR adverse event for that patient.~Parameter statistics were generated from a Poisson regression model with natural log of treatment duration (years) as an offset variable, and adjusted for baseline EDSS score, treatment group, age, sex, number of relapses in the 2 years prior to screening, in which a contrast comparing treatment groups were constructed. Adjusted mean estimates were adjusted estimates of event rates within treatment group."|Day 1 to Month 4|Safety analysis set|||events per year||Standard Error|Mean
2628773|NCT01874132|Other Pre-specified|Quality of Life|Measured by the Satisfaction With Life Scale.|One year|||||||
2628774|NCT01874132|Secondary|Risk of Falls|Descriptive frequency of the number of participants who took ≥12 seconds to complete the Timed Get-up and Go test, and those who took less than 12 seconds (low risk of falling).|One year||||Participants|||Count of Participants
2628775|NCT01874132|Primary|Cardiovascular Disease Risk Factors|Descriptive frequency of the number of cardiovascular risk factors aggregated in each participant. The risk factors considered were: (i) hypertension; (ii) obesity; and (iii) dyslipidemia.|one year|Only 48 participants completed the body composition, blood pressure and hematology assessments, and were included in analysis.|||participants|||Number
2628776|NCT01874119|Primary|Number of Patients With Complete Response During Inpatient Admission|No vomiting from the initiation of through 48 hours following the final dose of HD IL-2|From the initiation of through 48 hours following the final dose of Interleukin-2||||Participants|||Count of Participants
2628777|NCT01874054|Secondary|Progression-free Survival|The time from first dose of study medication to first documentation of disease progression/relapse, or to death due to any cause, whichever occurs first.|Up to 49 months|All patients who received at least 2 cycles of combination treatment and had a baseline tumor assessment and at least 1 post-baseline tumor assessment, or who had documented disease progression (including clinical disease progression) at any time after the first dose of combination therapy.|||months||95% Confidence Interval|Median
2628778|NCT01874054|Secondary|Duration of Response|The time from first observation of remission to disease progression/relapse or death from any cause, whichever occurs first.|Up to 47.8 months|Patients with a complete or partial response who received at least 2 cycles of combination treatment and had a baseline tumor assessment and at least 2 post-baseline tumor assessment, or who had documented disease progression (including clinical disease progression) at any time after the first dose of combination therapy.|||months||95% Confidence Interval|Median
2628791|NCT01873950|Secondary|Change in PR, QRS, J-Tpeak, Tpeak-Tend and QTc Using Exposure/Response (Dofetilide and Verapamil Arms)|"The exposure response analysis will be performed for each treatment and will use a linear or nonlinear model (as determined by visual inspection) to quantify the relationship between exposure and Baseline and placebo adjusted change from Baseline for each ECG parameter (same as for primary analysis).~The magnitude of change (mean and 95% CI) in QTc for the observed mean Cmax for each drug may be calculated."|24 hours||||ms per ng/ml||95% Confidence Interval|Mean
2628779|NCT01874054|Secondary|Overall Best Response Rate|Percentage of participants who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), stable disease (SD, failure to obtain a complete or partial response or progressive disease), or progressive disease (PD, any new lesion or increase by 50% or more of previously involved sites from nadir) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma|Up to 4.6 months|All patients who received at least 2 cycles of combination treatment, had a baseline tumor assessment, and at least 1 post-baseline tumor assessment, or who had documented disease progression (including clinical disease progression) any time after the first dose of combination therapy.|||Participants|||Count of Participants
2628780|NCT01874054|Secondary|Incidence of Dose-limiting Toxicities|Incidence of dose-limiting toxicity (DLT) was evaluated in an initial safety cohort of 10 patients who were followed for protocol-defined DLT events until Cycle 2 Day 1.|Up to 3 weeks; first cycle of therapy through the first day of Cycle 2|An initial safety cohort of 10 patients who enrolled and received at least 1 dose of brentuximab vedotin were evaluated for this outcome.|||Participants|||Count of Participants
2628781|NCT01874054|Primary|Incidence of Adverse Events (AEs)|All AEs reported after initiation of treatment and pre-existing conditions that worsen after initiation of treatment will be considered treatment-emergent AEs (TEAEs). All AEs will be coded by system organ class, MedDRA preferred term, and severity grade using NCI CTCAE V4.03. All recorded AEs will be included in the data listings.|Up to 13.8 months|All subjects who were enrolled and received at least 1 dose of brentuximab vedotin.|||Participants|||Count of Participants
2628782|NCT01874054|Primary|Complete Remission Rate|Complete remission rate among all subjects (Phase 1 and 2 combined) treated at the dose level selected for Phase 2. Complete remission (CR) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma is a disappearance of all evidence of disease.|Up to 4.6 months|All patients who received at least 2 cycles of combination treatment at the recommended dose level and had a baseline tumor assessment and at least 1 postbaseline tumor assessment, or who had documented disease progression (including clinical disease progression) at any time after the first dose of combination therapy at the recommended dose level.|||percentage of participants||95% Confidence Interval|Number
2628783|NCT01873989|Primary|Change in Sexual Dysfunction From Baseline to Week 8|Decreased sexual dysfunction will be assessed using the Erectile Function (EF) subscale of the International Index of Erectile Function (IIEF). The EF subscale has 6 items scored on a zero to five Likert-type scale. Change in sexual dysfunction was calculated by subtracting the mean EF subscale score at week 8 from the mean EF subscale score at baseline. The range of the EF subscale is 0-30 (with higher scores representing greater functioning). The Cut-offs for the EF subscales are as follows: no erectile dysfunction (score 26-30), mild erectile dysfunction (22-25), mild to moderate erectile dysfunction(17-21), moderate erectile dysfunction (11-16), and severe erectile dysfunction (0-10).|8 weeks||||units on a scale||Standard Deviation|Mean
2628784|NCT01873989|Primary|Change in Pain Ratings|Pain ratings will be assessed by self-report (4 items from Brief Pain Inventory). Change in pain ratings was assessed by examining the differences between pain ratings at baseline and week 8. Higher values are considered to be a worse outcome. The scale range is 0-10.|8 weeks||||units on a scale||95% Confidence Interval|Mean
2628785|NCT01873989|Primary|Number of Participants Demonstrating Abstinence|Number of participants who provided four consecutive weekly urines that were negative for illicit opioids in weeks 5 through 8.|8 weeks||||Participants|||Count of Participants
2628786|NCT01873950|Secondary|Change in Ventricular Gradient Using Exposure/Response (Ranolazine and Quinidine Arms)|"The exposure response analysis will be performed for each treatment and will use a linear or nonlinear model (as determined by visual inspection) to quantify the relationship between exposure and Baseline and placebo adjusted change from Baseline for each ECG parameter (same as for primary analysis).~The magnitude of change (mean and 95% CI) in ventricular gradient for the observed mean Cmax for each drug may be calculated."|24 hours||||mV.ns per mcg/ml||95% Confidence Interval|Mean
2628787|NCT01873950|Secondary|Change in Ventricular Gradient Using Exposure/Response (Dofetilide and Verapamil Arms)|"The exposure response analysis will be performed for each treatment and will use a linear or nonlinear model (as determined by visual inspection) to quantify the relationship between exposure and Baseline and placebo adjusted change from Baseline for each ECG parameter (same as for primary analysis).~The magnitude of change (mean and 95% CI) in ventricular gradient for the observed mean Cmax for each drug may be calculated."|24 hours||||mV.ns per ng/ml||95% Confidence Interval|Mean
2628788|NCT01873950|Secondary|Change in Spatial QRS-T Angle Using Exposure/Response (Ranolazine and Quinidine Arms)|"The exposure response analysis will be performed for each treatment and will use a linear or nonlinear model (as determined by visual inspection) to quantify the relationship between exposure and Baseline and placebo adjusted change from Baseline for each ECG parameter (same as for primary analysis).~The magnitude of change (mean and 95% CI) in spatial QRS-T angle for the observed mean Cmax for each drug may be calculated."|24 hours||||degrees per mcg/ml||95% Confidence Interval|Mean
2628789|NCT01873950|Secondary|Change in Spatial QRS-T Angle Using Exposure/Response (Dofetilide and Verapamil Arms)|"The exposure response analysis will be performed for each treatment and will use a linear or nonlinear model (as determined by visual inspection) to quantify the relationship between exposure and Baseline and placebo adjusted change from Baseline for each ECG parameter (same as for primary analysis).~The magnitude of change (mean and 95% CI) in spatial QRS-T angle for the observed mean Cmax for each drug may be calculated."|24 hours||||degrees per ng/ml||95% Confidence Interval|Mean
2628790|NCT01873950|Secondary|Change in PR, QRS, J-Tpeak, Tpeak-Tend and QTc Using Exposure/Response (Ranolazine and Quinidine Arms)|"The exposure response analysis will be performed for each treatment and will use a linear or nonlinear model (as determined by visual inspection) to quantify the relationship between exposure and Baseline and placebo adjusted change from Baseline for each ECG parameter (same as for primary analysis).~The magnitude of change (mean and 95% CI) in QTc for the observed mean Cmax for each drug may be calculated."|24 hours||||ms per mcg/ml||95% Confidence Interval|Mean
2628817|NCT01873495|Primary|Bone Marrow Aspirate to Confirm Continuous Remission|Bone marrow aspirate to confirm continuous remission will be obtained before starting maintenance and at 3 and 6 months from the start of maintenance.|3 months|No patients entered the maintenance phase of this study.||||||
2628792|NCT01873950|Secondary|Change in Relationship (Ratio) Between Heart Rate and QT|Different post-dose time-points employ different techniques for altering heart rate (leg raises and postural maneuvers). Using the measurements from all the time-points of postural maneuvers, the QT/RR relationship was modeled as a linear relationship between the square root of RR in seconds and QT in seconds and computed on a by subject, treatment and time-point basis. The change in the QT and heart rate relationship was assessed as the difference (mean and 95% CI) between the slopes from the models for each drug vs. placebo.|24 hours||||ratio||95% Confidence Interval|Mean
2628793|NCT01873950|Primary|Placebo, and Baseline-adjusted Changes in Ventricular Gradient|Compute maximum mean placebo, and baseline-adjusted change for: ventricular gradient (mV*ms).|24 hours||||mV*ms||95% Confidence Interval|Least Squares Mean
2628794|NCT01873950|Primary|Placebo, and Baseline-adjusted Changes in Spatial QRS-T Angle|Compute maximum mean placebo, and baseline-adjusted change for: spatial QRS-T angle (degrees)|24 hours||||degrees||95% Confidence Interval|Least Squares Mean
2628795|NCT01873950|Primary|Placebo, and Baseline-adjusted Changes in PR, QRS, J-Tpeak, Tpeak-Tend and QTc|Compute maximum mean placebo, and baseline-adjusted change for: PR (ms), QRS (ms), J-Tpeak (ms), Tpeak-Tend (ms) and QTc (ms)|24 hours||||ms||95% Confidence Interval|Least Squares Mean
2628796|NCT01873859|Primary|Change of Baseline Creatinine 48 hr After Recieving Contrast Media in the Presence or Absence of Metformin Use.||48 hours from the baseline||||mg/dl||Standard Deviation|Mean
2628797|NCT01873859|Primary|Incidence of Lactic Acidosis|Metformin-associated lactic acidosis (MALA) was defined as an arterial pH <7.35 and plasma lactate concentration >5 mmol ⁄ L.|48 hrs||||participants|||Number
2628798|NCT01873846|Secondary|Any Graded Slit Lamp Finding > 2|Slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Corneal staining grades were computed as the maximum grade over grades taken within each of five different eye locations (central, inferior, nasal, superior, and temporal). Eyes with multiple visits are counted once for the highest grade.|2 weeks|Percentages are based on the number of dispensed eyes with non-missing scores.|||Eyes|Eyes||Count of Units
2628799|NCT01873846|Secondary|Lens Performance Assessment|High Contrast Distance logMAR Lens VA Change From Baseline to Week 2.|2 weeks|High contrast distance lens visual acuity (VA) was assessed at Screening/Dispensing on the Test (newly dispensed) lenses, and at the follow-up visit(s). The population included subjects with baseline and at least one post-baseline assessment.|||Log of Minimum Angle of Resolution VA|Eyes|Standard Deviation|Mean
2628800|NCT01873846|Primary|Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes.|"Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: These contact lenses help maintain healthy, white eyes. Prefer study lenses Prefer usual lenses About the same as usual lenses"|7 days|There were 380 eligible subjects with lenses dispensed.|||Participants|||Count of Participants
2628801|NCT01873846|Primary|Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long.|"Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: These contact lenses deliver exceptional clarity and comfort all day long. Prefer study lenses Prefer usual lenses About the same as usual lenses"|7 days|There were 380 eligible subjects with lenses dispensed.|||Participants|||Count of Participants
2628802|NCT01873846|Primary|Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?|"Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to answer the following question: How would you say these contact lenses compare overall with the contact lenses you usually use? Prefer study lenses Prefer usual lenses About the same as usual lenses"|7 days|There were 380 eligible subjects with lenses dispensed.|||Participants|||Count of Participants
2628803|NCT01873729|Secondary|Clinical Global Impression (CGI)|The Clinical Global Impression (CGI) scale allows the clinician to rate the severity of illness, change over time, and efficacy of medication, taking into account the patient's clinical condition and the severity of side effects. The CGI subscales include the Clinical Global Severity of ADHD (CGI-S) which is scored on a 7 point scale (1=not ill, 7=extremely ill) and the Clinical Global Improvement of ADHD (CGI-I) which is also scored on a 7 point scale (1=very much improved, 7=very much worse). The number of subjects with CGI-Improvement scores less than or equal to 2 (very much improved) at the end of the study is reported.|Six weeks||||Participant|||Number
2628804|NCT01873729|Primary|Change in Adult Investigator Symptom Rating Scale (AISRS) Scores From Baseline|The Adult Investigator Symptom Rating Scale (AISRS) is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms).|Baseline and Six weeks||||Units on a scale||Standard Deviation|Mean
2628805|NCT01873586|Secondary|Medical Outcomes: Maintenance of Lower Extremity Neurological Function at All Available Time-points.|"Posterolateral fusion study in which one spinal level is treated with both the study and control arm. The symptomatic posterolateral spinal side is OsteoStrux and the contralateral posterolateral spinal side is local autograft.~NA (Not Applicable): Neurological function data was not able to be analyzed as there was a limitation of the method in the ability to distinguish between posterolateral sides in a neurological function assessment. Neurological function is indistinguishable between the right and left posterolateral sides of the lower extremities using the methods in the protocol. Therefore, this outcomes measure was not applicable."|upto 24 months|NA (Not Applicable): Neurological function data was not able to be analyzed as there was a limitation of the method in the ability to distinguish between posterolateral sides in a neurological function assessment.||||||
2628815|NCT01873495|Secondary|Consolidation Toxicities|Toxicities will be monitored by history, physical examination, and laboratory monitoring (CBC, serum chemistries to include renal and liver function tests) obtained weekly during consolidation and monthly during maintenance according to standard of care (Appendices C and D). Toxicity will be assessed according to the NCI Common Toxicity Criteria Version 4.0 (available at the NCI web site http://ctep.cancer.gov/reporting/ctc.html).|12 weeks|Two participants experienced toxicities: thrombocytopenia and atrial flutter.|||Participants|||Count of Participants
2628806|NCT01873586|Secondary|Medical Outcomes: Visual Analog Scale (VAS) Back Pain at All Available Time-points.|"The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of 0/no pain at all and 100/worst pain imaginable.~The study in this scale is used for back pain. A lower score represents a better score."|upto 24 months|"Posterolateral fusion study in which one level is treated with both the study and control arm. One side is OsteoStrux combined with bone marrow aspirate (BMA) and the other side is local autograft combined with BMA. Therefore, all results per patient are the same results. All level results are the same unless specifically indicated, per side."|||units on a scale||Standard Deviation|Mean
2628807|NCT01873586|Secondary|Medical Outcomes: Worst Leg Pain on the Visual Analog Scale (VAS) at All Available Time-points.|"The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of 0/no pain at all and 100/worst pain imaginable.~The study in this scale is used for the worst leg pain. A lower score represents a better score."|upto 24 months|"Posterolateral fusion study in which one level is treated with both the study and control arm. One side is OsteoStrux combined with bone marrow aspirate (BMA) and the other side is local autograft combined with BMA. Therefore, all results per patient are the same results. All level results are the same unless specifically indicated, per side."|||units on a scale||Standard Deviation|Mean
2628808|NCT01873586|Secondary|Medical Outcomes: Oswestry Disability Index (ODI), at All Available Time-points.|The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by surgeons, clinicians and researchers to quantify disability for low back pain. The questionnaire is self-completed and covers 10 topics about pain intensity, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Scores are from 0-100 and a lower score represents a better score.|upto 24 months|"Posterolateral fusion study in which one level is treated with both the study and control arm. One side is OsteoStrux combined with bone marrow aspirate (BMA) and the other side is local autograft combined with BMA. Therefore, all results per patient are the same results. All level results are the same unless specifically indicated, per side."|||units on a scale||Standard Deviation|Mean
2628809|NCT01873586|Secondary|Number of Posterolateral Levels With Correlation of Fusion Ratings by X-ray and CT Scan|Correlation of x-ray with computed tomography scan analysis at the 12 month follow-up time point.|12 months||||Posterolateral Gutters|Posterolateral Gutters||Count of Units
2628810|NCT01873586|Secondary|EQ-5D Health State Visual Analog Scale (VAS) Questionnaire at All Available Time-points|"EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The EQ-5D-5l has a descriptive system and the EQ visual analogue scale (EQ VAS).The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels which results in a 1-5 level selected for that dimension. The level when added together describes the patient's health state.~The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. Score is 0-100 and a lower score represents a better score."|upto 24 months|"Posterolateral fusion study in which one level is treated with both the study and control arm. One side is OsteoStrux combined with bone marrow aspirate (BMA) and the other side is local autograft combined with BMA. Therefore, all results per patient are the same results. All level results are the same unless specifically indicated, per side."|||units on a scale||Standard Deviation|Mean
2628811|NCT01873586|Secondary|Interbody Fusion as Determined by CT Post-surgery at Available Time-points|NA (Not Applicable): This post-market study was primarily a posterolateral fusion study. Interbody fusion was a secondary endpoint. As interbody fusion was completed per standard of care, transforaminal lumbar interbody fusion (TLIF), posterolateral fusion (PLF), or posterior lumbar interbody fusion (PLIF) with or without the use of an interbody spacer and any graft material could be used per the Investigator discretion. As interbody fusion was not a primary endpoint and was indistinguishable per control and study arms, interbody fusion results were not analyzed.|12 months|NA (Not Applicable): As interbody fusion was not a primary endpoint and was indistinguishable per control and study arms, interbody fusion results were not analyzed.||||||
2628812|NCT01873586|Secondary|Interbody Fusion as Determined by X-ray at 3, 6, 12 and 24 Months|NA (Not Applicable): This post-market study was primarily a posterolateral fusion study. Interbody fusion was a secondary endpoint. As interbody fusion was completed per standard of care, transforaminal lumbar interbody fusion (TLIF), posterolateral fusion (PLF), or posterior lumbar interbody fusion (PLIF) with or without the use of an interbody spacer and any graft material could be used per the Investigator discretion. As interbody fusion was indistinguishable per arms, data were not collected due to a limitation in the method of analysis per protocol. Therefore data was not analyzed and outcome is NA.|upto 24 months|NA (Not Applicable): As interbody fusion was not a primary endpoint and was indistinguishable per control and study arms, interbody fusion results were not analyzed.||||||
2628813|NCT01873586|Secondary|Number of Posterolateral Gutters Showing Evidence of Arthrodesis (Fusion) as Measured by CT|Each posterolateral gutter was assessed for extent of fusion using computed tomography (CT) scan.|12 months|Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).|||Posterolateral gutters|Posterolateral gutters||Count of Units
2628814|NCT01873586|Primary|Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays.|Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).|up to 24 months|Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).|||Posterolateral Gutters|Posterolateral Gutters||Count of Units
2628819|NCT01873495|Primary|Disease Status Assessment Prior to Each Consolidation Cycle|Disease status will be assessed by a bone marrow aspirate and biopsy prior to each of 3 consolidation cycles (to ensure that patients are still in remission).|14 days||||Participants|||Count of Participants
2628820|NCT01873417|Secondary|Number of DMF-treated Participants Who Discontinued DMF Due to GI-related Events Requiring Symptomatic Therapy|The last symptomatic therapy prior to last dose of study medication was used to summarize the number of participants who discontinued DMF due to GI-related events. Participants may have taken more than one symptomatic therapy but are counted only once in the 'All Therapies' category.|12 Weeks|Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)|||participants|||Number
2628821|NCT01873417|Secondary|Summary of Use and Days on Symptomatic Therapy, by Category|The total duration (in days) of use of each symptomatic therapy by participants as a result of GI symptoms experienced by DMF-treated participants is presented. If a participant had multiple different therapies on the same day, the days on symptomatic therapy was calculated as 1 day in the 'All Therapies' category.|12 Weeks|Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]). n= number of participants using the therapy specified.|||days||Standard Deviation|Mean
2628822|NCT01873417|Secondary|Participants' Use of Symptomatic Therapy, by Type and Category|The symptomatic therapies used by DMF-treated participants were self-reported by type and category. Each participant may have taken more than one symptomatic therapy type but was counted only once within each therapy category. Acetylsalicylic acid (ASA) is abbreviated in the table.|12 Weeks|Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)|||participants|||Number
2628823|NCT01873417|Secondary|Percentage of DMF-treated Participants Who Required GI Symptomatic Therapy|Percentage of participants reporting that they required GI symptomatic therapy, based on the MOGISS.|12 Weeks|Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)|||percentage of participants|||Number
2628824|NCT01873417|Primary|Duration of GI-related Episodes in DMF-treated Participants|In participants who took symptomatic therapy, the median duration of acute GI episodes (in hours) was summarized for the overall treatment period, by symptom (nausea, diarrhea, lower abdominal pain, upper abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence). Table only includes the symptom duration for those symptoms with start and stop times entered in the eDiary (evaluable GI episodes), based on the MAGISS.|12 Weeks|Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]); n=number of participants with evaluable GI symptom specified.|||hours||Full Range|Median
2628825|NCT01873417|Primary|Percentage of DMF-treated Participants Who Reported GI-related Symptoms and Who Utilized Symptomatic Therapy|Percentage of participants reporting GI symptoms on the MOGISS, by those who utilized symptomatic therapy.|12 Weeks|Safety Population (participants who received at least 1 dose of DMF, recorded in diary data)|||percentage of participants|||Number
2628826|NCT01873417|Primary|Worst Severity Score of Overall GI Events, Modified Acute Gl Symptom Scale|Severity of GI-related events in DMF-treated participants using the MAGISS to measure GI symptoms, based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.|12 Weeks|Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]).|||units on a scale||Standard Deviation|Mean
2628827|NCT01873417|Primary|Worst Severity Score of Overall Gastrointestinal (GI) Events, Modified Overall GI Symptom Scale (MOGISS)|Severity of GI-related events in DMF-treated participants using the MOGISS to measure GI symptoms, based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.|12 Weeks|Evaluable participants (treated participants who utilized symptomatic therapy during the overall treatment period [12 weeks]).|||units on a scale||Standard Deviation|Mean
2628828|NCT01873287|Secondary|Neuropsychological Evaluation|A separate battery of neuropsychological assessment measures will be administered to those children who choose to participate in this arm of the study. This battery includes measures of intelligence, language, visual-spatial/motor functions, attention, memory/working memory, executive functioning, academic achievement, as well as behavioural/socioemotional functioning.|1 month and 3 month|Participants assessed at 4- and 12-weeks post-injury using direct, standardized measures of intellectual functioning, verbal memory, executive functioning, attention/working memory, processing speed and fine motor abilities.|||Participants|||Count of Participants
2628829|NCT01873287|Secondary|Pediatric Quality of Life Inventory (PedsQL) Total Score at 4-weeks Post-injury|The PedsQL™ is a reliable and valid measure of health-related quality of life in healthy children and adolescents and those with acute and/or chronic health conditions. Parent versions exist for children aged 2 to 18 years (in 4 age groups) and child versions for those aged 5 and over. The inventory covers four domains: physical, emotional, social and school. Items are calculated and transformed into an overall score with a range of 0 to 100 points, with more points indicating better quality of life. This secondary outcome measure will be used to determine the impact of PCS on quality of life on patients and families.|1 month|Completed PedsQL at 1-month post-concussion.|||units on a scale||95% Confidence Interval|Mean
2628830|NCT01873287|Primary|Count of Children Who Have Persistent Post-concussive Symptoms (PCS) at One-month Follow-up.|The primary outcome is the number of of children aged 5 - 17 years who have PCS at one-month follow-up. A PCS case is defined as an increase from pre-concussion baseline of three or more symptoms on the validated PCSI at one-month (consistent with the ICD-10 definition of PCS).|1 month|Completed 1-month followup.|||Participants|||Count of Participants
2628831|NCT01872910|Secondary|Part A: Patient Global Impression of Improvement (PGI-I) Scale Score|PGI-I is a participant-rated instrument that measures the improvement of the participants symptoms on a 7-point scale: 1 (very much improved), 4 (no change), and 7 (very much worse). LS mean was calculated using Mixed Effect Model Repeated Measures (MMRM) adjusted for treatment, time, the interaction of treatment and time and baseline pain VAS and fixed effects.|2, 4, 8, 12 and 24 h post-dose|Part A participants who were randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose PGI-I assessment. Participants who received rescue medication were not included in the specific timepoints post administration of rescue medication.|||units on a scale||95% Confidence Interval|Least Squares Mean
2629214|NCT01868074|Primary|Change in Arch Drop|Measurement of Arch Drop (Sitting arch height minus standing arch height) using Arch Height Index Measurement System|baseline, 8 weeks postpartum||||mm||Standard Error|Mean
2628832|NCT01872910|Secondary|Part A: Time to Onset of Meaningful Pain Relief|Time to onset of meaningful pain relief is defined as the time from study drug administration to the measured onset of meaningful pain relief in hours as reported by the participant. Participants who received rescue mediation prior to meaningful pain relief were censored at the time the rescue medication was received.|Study drug administration to meaningful pain relief (0 to 24 h post-dose)|FAS: Part A participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Participants censored: Part A LY3023703=24, Celecoxib=2, Placebo=15.|||h||95% Confidence Interval|Median
2628833|NCT01872910|Secondary|Part A: Time to Onset of First Perceptible Pain Relief|Time to onset of the first perceptible pain relief is defined as the time from study drug administration to the measured onset of first perceptible pain relief in hours as reported by the participant. Participants who received rescue mediation prior to first perceptible pain relief were censored at the time the rescue medication was received.|Study drug administration to first perceptible pain relief (0 to 24 h post-dose)|FAS: Part A participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Participants censored: Part A: LY3023703=11, Celecoxib=2, Placebo=9.|||h||95% Confidence Interval|Median
2628834|NCT01872910|Secondary|Time to First Use of Rescue Medication|"Time to first use of rescue medication is defined as the time from study drug administration to the measured first use of rescue medication in hours. Participants were censored at 24 h post-dose if no rescue medication was administered.~Pre-Part B used 3 participants in order for the study site to develop proficiency in the dialysate placement, collection, and maintenance techniques. There were no planned efficacy analysis for Pre-Part B per protocol."|Study drug administration to first use of rescue medication (0 to 24 h post-dose)|FAS: All data from all participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Participants censored: Part A: LY3023703=5, Celecoxib=18, Placebo=12, Part B: LY3023703=0, Placebo=2.|||h||95% Confidence Interval|Median
2628835|NCT01872910|Secondary|Summed Pain Intensity Difference (SPID) Over the First 24 Hours Post-Dose as Measured by a 4-point Categorical Scale|"The summed (time-weighted) pain intensity difference to baseline (SPID) at 4, 6, 8, 12, and 24 h post-dosing, as measured by a participant-rated 4-point categorical scale of 0 (no pain) to 3 (severe pain) and was calculated as: the area under the change in pain intensity versus time curve. Total scores range: -24 (best) to 8 (worst) for SPID 0 to 8 h. Score ranges for SPID(0-4h), SPID(0-6), SPID(0-12) and SPID(0-24) are -12 to 4, -18 to 6, -36 to 12 and -72 to 24 respectively. Participants were required to have moderate (score=2) or severe (score=3) pain at baseline in order to be eligible for randomization.LS mean were calculated using ANCOVA and was adjusted for treatment as a fixed effect and baseline pain intensity as a continuous covariate. The measure of dispersion reported is 95% CrI not CI. A negative direction indicated a pain reduction from baseline.~There were no planned efficacy analysis for Pre-Part B per protocol."|0 to 4, 0 to 6, 0 to 8, 0 to 12, and 0 to 24 h post-dose|FAS: All data from all participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Pain assessments after rescue medication were imputed using LOCF from the pain assessment prior to rescue therapy.|||units on a scale||95% Confidence Interval|Least Squares Mean
2628836|NCT01872910|Secondary|Weighted Mean Change From Baseline in Pain Intensity Over the First 24 Hours Post-Dose as Measured by VAS|"Pain intensity was rated by the participant on a 100-mm VAS: 0 mm (no pain) and 100 mm (worst pain imaginable). The participant marked the line at the point that corresponded with his or her perception of post oral surgery pain. Weighted mean change from baseline was calculated as: [area under the change in pain intensity versus time curve] / [time period that is (i.e.) 24 h for 0 to 24 h endpoint]. The baseline pain intensity was the pain assessment prior to dosing of study medication. LS mean were calculated using ANCOVA adjusted for treatment, time and interaction of treatment as a fixed effect and baseline pain VAS as a continuous covariate. The measure of dispersion reported is the 95% CrI not CI. A negative direction indicated a pain reduction from baseline.~Pre-Part B used 3 participants in order for the study site to develop proficiency in the dialysate placement, collection, and maintenance techniques. There were no planned efficacy analysis for Pre-Part B per protocol."|Part A and B: 0 to 4, 0 to 6, 0 to 12, and 0 to 24 h post-dose and Part B 0 to 8 h post-dose|FAS: All data from all participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Pain assessments after rescue medication were imputed using LOCF from the pain assessment prior to rescue therapy.|||mm||95% Confidence Interval|Least Squares Mean
2628837|NCT01872910|Secondary|Total Pain Relief (TOPAR) Score at 4, 6, 8, 12 and 24 Hours Post-Dose|"TOPAR was calculated as the area under the pain relief versus time curve of the participant reported pain relief scores from the 5-point pain relief scale of 0 (no pain relief) to 4 (complete pain relief). LS mean were calculated using ANCOVA adjusted for treatment as a fixed effect. The measure of dispersion reported is CrI not CI. A negative direction indicated a pain relief from baseline.~Pre-Part B used 3 participants in order for the study site to develop proficiency in the dialysate placement, collection, and maintenance techniques. There were no planned efficacy analysis for Pre-Part B per protocol."|0 to 4, 0 to 6, 0 to 8, 0 to 12, and 0 to 24 h post-dose|FAS: All data from all participants randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 post-dose efficacy assessment. Pain assessments after rescue medication were imputed using LOCF from the pain assessment prior to rescue therapy excluding Pre-Part B.|||pain relief * h||95% Confidence Interval|Least Squares Mean
2628849|NCT01872689|Secondary|Time to First Event of >/=15% Absolute Decrease in Percentage of Predicted DLco or Death From Any Cause|DLco is a measure of the gas transfer. Predicted DLco is based on sex, age, and height of a person. Percent of predicted DLco (in %) = [(observed DLco)/(predicted DLco)]*100. Time from randomization to first occurrence of >/=15% absolute decrease in percentage of predicted DLco or death from any cause was reported. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline up to the event of >/=15% absolute decrease in percentage of predicted DLco or death from any cause (up to Week 122)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Median
2629215|NCT01868035|Secondary|Overall Survival|Overall survival (time to death) is defined from the start of treatment to the date of death from any cause.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population|||months||95% Confidence Interval|Median
2628838|NCT01872910|Primary|Part A: Weighted Mean Change From Baseline in Pain Intensity Over the First 8 Hours Post-Dose Using VAS|Pain intensity was rated by the participant on a 100-mm VAS: 0 mm (no pain) and 100 mm (worst pain imaginable). The participant marked the line at the point that corresponded with his or her perception of pain. Weighted mean change from baseline was calculated as: [the area under the change in pain intensity versus time curve] / 8 hours (h). The baseline pain intensity was the pain assessment prior to dosing of study medication (0 h). Least Squares (LS) mean were calculated using a Bayesian analysis of covariance analysis (ANCOVA) adjusted for treatment as a fixed effect and baseline pain VAS as a continuous covariate. The measure of dispersion reported is 95% Credible Interval (CrI) not Confidence Interval (CI). A negative direction indicates a pain reduction from baseline.|0 to 8 h post-dose|Full Analysis Set (FAS): Part A participants who were randomly assigned to treatment who received at least 1 dose of study medication and who had at least 1 postdose efficacy assessment. Pain assessments after rescue medication were imputed using last observation carried forward (LOCF) from the pain assessment prior to rescue therapy.|||mm||95% Confidence Interval|Least Squares Mean
2628839|NCT01872819|Secondary|Rate of Complete Response, Defined by Criteria of Cheson et al.|"Number of patients who achieved a Complete Response (CR) with Minimal Residual Disease (MRD), a Complete Response with incomplete hematologic recovery (CRi), or showed reduced blasts in their bone marrow by flow cytometry (Cytoreduction).~Cheson et al. defines a CR as: Bone Marrow blasts <5%, absence of circulating blasts and blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count >1.0 x 10^9/L, and platelet count >100 x 10^9/L. Cheson et al. defines a CRi as: all CR criteria except for residual neutropenia (<1.0 x 10^9/L) or thrombocytopenia (<100 x 10^9/L)."|Baseline up to 2 years|14 patients received therapy. Out of 14 patients treated, 9 were evaluable (4 patients died prior to D14-21 marrow and 1 patient refused the D14-21 marrow).|||Patients|||Number
2628840|NCT01872819|Primary|Achievability of Performing Individualized Drug Screening and Initiating Therapy Based on the Results of the Drug Screen for Poor Risk Patients With Relapsed or Refractory AML|Whether treatment was administered in the time frame based on the high throughput drug screen. Time from sample procurement to assay results.|Up to 21 days|14 patients were treated.|||days||Full Range|Median
2628841|NCT01872715|Secondary|Patient Satisfaction Question|The patient satisfaction question was answered by the subject at week 2, week 6, and week 12. The subject was asked how satisfied they were with this treatment (doxycycline MR) for rosacea.|Week 2, 6, and 12||||participants|||Number
2628842|NCT01872715|Secondary|Patient Global Assessment (PGA) of Rosacea Scores|Patient Global Assessment (PGA) of Rosacea: 0 = clear, no signs or symptoms present; 1 = Near clear, 1 or 2 papules; 2 = mild, some (3 to 10) papules/pustules; 3 = moderate, moderate (11 to 19) number of papules and pustules; 4 = severe, numerous (≥ 20) papules/pustules; nodules|Baseline, Weeks 2, 6, and 12||||participants|||Number
2628843|NCT01872715|Secondary|Rosacea-Specific Quality of Life Index|ROSACEA-SPECIFIC QUALITY OF LIFE INDEX©: average of scores to 22 questions on a 5 point scale (1 = never, 5 = all the time)|Baseline, Weeks 2, 6, and 12|Intent-to-Treat (ITT) population: All subjects who were enrolled and had at least 1 posttreatment administration evaluation. This is the primary population for efficacy analyses.|||units on a scale||Standard Deviation|Mean
2628844|NCT01872715|Primary|Rosacea Score on the Visual Analog Scale|VAS = visual analog scale, 10 cm scale in which 0 = no rosacea, 10 = worst rosacea imaginable|Baseline, Weeks 2, 6, and 12|Intent-to-Treat (ITT) population: All subjects who were enrolled and had at least 1 posttreatment administration evaluation. This is the primary population for efficacy analyses.|||units on a scale||Standard Deviation|Mean
2628845|NCT01872689|Secondary|Elimination Half-Life (t1/2) of Lebrikizumab|Elimination half-life is the time measured for the plasma drug concentration to decrease by one-half during the elimination phase of the drug. Analysis was performed on PK-Evaluable Population. Participants who received lebrikizumab were only included in the analysis.|Pre-dose (Hour 0) at Weeks 1, 4, 12, 24, 36, 64, 76, 88, 104; and at 4, 12, and 18 weeks post-last dose (last dose = Week 104)|Analysis was performed on PK-Evaluable Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||days||Standard Deviation|Mean
2628846|NCT01872689|Secondary|Minimum Observed Serum Concentration (Cmin) of Lebrikizumab|Participants who received lebrikizumab were only included in the analysis.|Predose (Hour 0) at Weeks 4, 12, 24, and 36|Analysis was performed on PK-Evaluable Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and ‘Number Analyzed’ signifies number of participants evaluable at specified time points.|||mcg/mL||Standard Deviation|Mean
2628847|NCT01872689|Secondary|Minimum Observed Serum Concentration (Cmin) of Lebrikizumab at Week 52|Participants who received lebrikizumab were only included in the analysis.|Predose (Hour 0) at Week 52|Analysis was performed on Pharmacokinetic (PK)-Evaluable Population, which included all participants who received at least one dose of study drug and had at least one non-missing PK observation. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
2628848|NCT01872689|Secondary|Percentage of Participants With Anti-therapeutic Antibody (ATA) to Lebrikizumab|ATA to lebrikizumab was tested using a validated immunoassay. A positive ATA result was defined as one in which the presence of detectable ATAs could be confirmed by competitive binding with lebrikizumab. Percentage of participants with positive results for ATA at Baseline and at post-baseline time points were reported. Only participants who received lebrikizumab were included in the analysis.|Baseline and Post-Baseline (assessed at multiple time points: Weeks 4, 12, 24, 36, 52, 56, 64, 76, and at safety follow-up up to Week 122)|Analysis was performed on Safety Population (all participants who received at least one dose of study drug grouped according to the actual treatment received). 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure; ‘Number Analyzed’ = number of participants evaluable at indicated time points.|||percentage of participants|||Number
2628850|NCT01872689|Secondary|Percentage of Participants With an Event of >/=15% Absolute Decrease in Percentage of Predicted DLco or Death From Any Cause|DLco (in mL/min/mmHg) is a measure of the gas transfer. Predicted DLco is based on sex, age, and height of a person. Percent of predicted DLco (in %) = [(observed DLco)/(predicted DLco)]*100.|Baseline up to the event of >/=15% absolute decrease in percentage of predicted DLco or death from any cause (up to Week 122)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||percentage of participants|||Number
2628851|NCT01872689|Secondary|Time to Respiratory-Related Hospitalization|Time from randomization to first occurrence of an event of respiratory-related hospitalization was reported. Participants without an event were censored at the last known alive day, study Day 368, or the last date during the double-blind period. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline up to the event of respiratory-related hospitalization (up to Week 122)|Analysis was performed on ITT Population for combination therapy cohorts only. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Median
2628852|NCT01872689|Secondary|Percentage of Participants With Respiratory-Related Hospitalization||Baseline up to the event of respiratory-related hospitalization (up to Week 122)|Analysis was performed on ITT Population for combination therapy cohorts only. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||percentage of participants|||Number
2628853|NCT01872689|Secondary|Time to First Event of Acute IPF Exacerbation|Time from randomization to first occurrence of an event of IPF exacerbation was reported. IPF exacerbation was defined as an event that met all of the following criteria as determined by the investigator: Unexplained worsening or development of dyspnea within the previous 30 days; And radiologic evidence of new bilateral ground-glass abnormality or consolidation, superimposed on a reticular or honeycomb background pattern, that is consistent with usual interstitial pneumonitis; And absence of alternative causes, or other events leading to acute lung injury. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline up to the event of acute IPF exacerbation (up to Week 122)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Median
2628854|NCT01872689|Secondary|Percentage of Participants With an Event of Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation|IPF exacerbation was defined as an event that met all of the following criteria as determined by the investigator: Unexplained worsening or development of dyspnea within the previous 30 days; And radiologic evidence of new bilateral ground-glass abnormality or consolidation, superimposed on a reticular or honeycomb background pattern, that is consistent with usual interstitial pneumonitis; And absence of alternative causes, such as left heart failure, pulmonary embolism, pulmonary infection (on the basis of endotracheal aspirate or bronchoalveolar lavage if available, or investigator judgment), or other events leading to acute lung injury (for example, sepsis, aspiration, trauma, reperfusion pulmonary edema).|Baseline up to the event of acute IPF exacerbation (up to Week 122)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||percentage of participants|||Number
2628855|NCT01872689|Secondary|Time to First Occurrence of SGRQ Total Score Worsening or Death From Any Cause|The SGRQ is a 50-item health-related QoL instrument that measured health impairment. The questionnaire contains 3 domains: symptoms, activity, and impacts. Items were assessed on various response scales, including a 5-point Likert scale and True/False scale. The SGRQ had a recall specification of 4 weeks. The SGRQ total score (summed weights) ranged from 0 to 100 with a lower score denoting a better health status. Time from randomization to first occurrence of an event of SGRQ total score worsening (defined as reaching minimal important difference [MID], that is, an increase in total score of >/=7) or death from any cause was reported. The median time to event was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline up to the event of SGRQ total score worsening or death from any cause, whichever occurred first (up to Week 122)|Analysis was performed on ITT Population for monotherapy cohort only. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Median
2628856|NCT01872689|Secondary|Percentage of Participants With an Event of St. George's Respiratory Questionnaire (SGRQ) Total Score Worsening or Death From Any Cause|The SGRQ is a 50-item health-related QoL instrument that measured health impairment. The questionnaire contains 3 domains: symptoms, activity, and impacts. Items were assessed on various response scales, including a 5-point Likert scale and True/False scale. The SGRQ had a recall specification of 4 weeks. The SGRQ total score (summed weights) ranged from 0 to 100 with a lower score denoting a better health status. Percentage of participants with an event of SGRQ total score worsening (defined as reaching minimal important difference [MID], that is, an increase in total score of >/=7) or death from any cause was reported.|Baseline up to the event of SGRQ total score worsening or death from any cause, whichever occurred first (up to Week 122)|Analysis was performed on ITT Population for monotherapy cohort only. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||percentage of participants|||Number
2628857|NCT01872689|Secondary|Annualized Rate of Decrease in A Tool to Assess Quality of Life in IPF (ATAQ-IPF) Questionnaire Total Score Over 52 Weeks|The ATAQ-IPF Version 3 was utilized that included 31 items within 5 domains: cough (6 items), dyspnea (7 items), exhaustion (6 items), emotional well-being (6 items), and independence (6 items). Each item was assessed on a scale ranging from 1 (Strongly disagree) to 4 (Strongly agree). The ATAQ-IPF had a recall specification of 2 weeks. Simple summation scoring was used to derive individual domain scores as well as a total score. ATAQ-IPF total score ranged from 31 to 124 with lower score indicating better quality of life (QoL). Annualized rates of decrease (slope throughout time from baseline to Week 52) in ATAQ-IPF questionnaire total score was assessed and reported.|Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52.|||units on a scale/year||Standard Error|Mean
2628858|NCT01872689|Secondary|Annualized Rate of Decrease in FVC Over 52 Weeks|Annualized rates of decrease (slope throughout time from baseline to Week 52) in FVC (in milliliters per year [mL/year]) was assessed and reported. FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position.|Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52.|||mL/year||Standard Error|Mean
2629411|NCT01866293|Primary|Maximally Tolerated Dose|This trial will be a standard 3 by 3 dose escalation design, where three daily dose levels (20mg, 40mg, and 60mg) will be investigated.|1 year|9 participants are evaluable. 2 participants never started treatment.|||mg|||Number
2628859|NCT01872689|Secondary|Progression-Free Survival (PFS)|FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC = [(observed FVC)/(predicted FVC)]*100. PFS was defined as time from randomization to death from any cause, all cause hospitalization, or a decrease from baseline of >/=10% in FVC, whichever occurred first. Participants without an event were censored at the last assessment during the double-blind treatment period. Any participant who underwent lung transplantation was censored at the date of the transplant. The median PFS was estimated using Kaplan-Meier method. 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline up to the event of death from any cause, all cause hospitalization, or a decrease from baseline of >/=10% in FVC, whichever occurred first (up to Week 122)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Median
2628860|NCT01872689|Secondary|Percentage of Participants With Event of Death, All Cause Hospitalization, or a Decrease From Baseline of >/=10% in FVC|FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC = [(observed FVC)/(predicted FVC)]*100.|Baseline up to the event of death from any cause, all cause hospitalization, or a decrease from baseline of >/=10% in FVC, whichever occurred first (up to Week 122)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||percentage of participants|||Number
2628861|NCT01872689|Secondary|Annualized Rate of Decrease in Diffusion Capacity of the Lung for Carbon Monoxide (DLco) Over 52 Weeks|Annualized rates of decrease (slope throughout time from baseline to Week 52) in DLco was assessed and reported. DLco (in milliliters per minute/millimeters of mercury [mL/min/mmHg]) is a measure of the gas transfer.|Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52.|||mL/min/mmHg/year||Standard Error|Mean
2628862|NCT01872689|Secondary|Time to First Occurrence of a >/=10% Absolute Decline in Percent Predicted FVC or Death From Any Cause|FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC (in %) = [(observed FVC)/(predicted FVC)]*100. Time from randomization to first occurrence of an event of >/=10% absolute decline in percent predicted FVC or death from any cause was reported. Participants without an event were censored at the last assessment during the double-blind treatment period. Any participant who underwent lung transplantation was censored at the date of the transplant. The median time to event was estimated using Kaplan-Meier method. 95% confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.|Baseline up to the event of >/=10% absolute decline in percent predicted FVC or death from any cause, whichever occurred first (up to Week 122)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||weeks||95% Confidence Interval|Median
2628863|NCT01872689|Secondary|Percentage of Participants With Event of Greater Than or Equal to (>/=) 10% Absolute Decline in Percent Predicted FVC or Death From Any Cause|FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC (in %) = [(observed FVC)/(predicted FVC)]*100.|Baseline up to the event of >/=10% absolute decline in percent predicted FVC or death from any cause, whichever occurred first (up to Week 122)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.|||percentage of participants|||Number
2628864|NCT01872689|Secondary|Annualized Rate of Decline in 6-Minute Walk Test (6MWT) Distance Over 52 Weeks|Annualized rates of decline (slope throughout time from baseline to Week 52) in 6MWT was assessed and reported. 6MWT was the distance (in meters [m]) that a participant could walk in 6 minutes.|Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52.|||m/year||Standard Error|Mean
2628865|NCT01872689|Primary|Annualized Rate of Decrease in Percent Predicted Forced Vital Capacity (FVC) Over 52 Weeks|Annualized rates of decrease (slope throughout time from baseline to Week 52) for percent predicted FVC was assessed and reported. FVC is a standard pulmonary function test. FVC is defined as the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted FVC is based on sex, age, and height of a person. Percent predicted FVC (in %) = [(observed FVC)/(predicted FVC)]*100.|Baseline up to Week 52 (assessed at Baseline, Weeks 1, 4, 12, 24, 36, 44, and 52)|Analysis was performed on ITT Population. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure at Week 52.|||percent predicted FVC/year||Standard Error|Mean
2628866|NCT01872611|Secondary|Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit||Day 7 up to any visit through Day 90|Full analysis set|||percentage of participants|||Number
2628867|NCT01872611|Secondary|Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit||Day 7 up to any visit through Day 90|Full analysis set|||percentage of participants|||Number
2628868|NCT01872611|Secondary|Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 60||Baseline to Day 60|Full analysis set|||Percentage of participants|||Number
2628869|NCT01872611|Secondary|Percentage of Participants With BCVA Improvement of ≥ 15 Letters From Preoperative Baseline to Day 90||Baseline to Day 90|Full analysis set|||Percentage of participants|||Number
2628870|NCT01872611|Primary|Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)|Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis.|Day 0 to Day 90|Full analysis set|||Percentage of participants|||Number
2630019|NCT01856790|Primary|Peak Post-prandial Venous Glucose Levels|peak post-prandial venous glucose levels obtained after breakfast, lunch, and dinner between closed loop (CL) alone and CL + liraglutide|48 hours||||mg/dL||Standard Error|Mean
2628871|NCT01872611|Primary|Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90|BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline to Day 14, and maintained through Day 90|Full analysis set|||Percentage of participants|||Number
2628872|NCT01872338|Secondary|Hopelessness|Hopelessness will be measured using the Beck Hopelessness Scale, score range 0-20, with higher scores indicating more hopelessness.|4 weeks, 8 weeks, 6 months and 12-months post-baseline||||score on a scale||Standard Error|Mean
2628873|NCT01872338|Secondary|Suicidal Ideation|clinician-administered Scale for Suicide Ideation (SSI), 0-38, higher score = higher suicidal ideation|12 months post-baseline|Linear mixed models, examining change from baseline over 12 months (5 assessments total), with effect of interest being time*cond interaction.|||score on a scale||Standard Error|Mean
2628874|NCT01872338|Secondary|Suicide Attempt|Defined as deliberate self-directed violence with injury or potential for injury and with explicit/implicit suicidal intent|12 months post-baseline|count of suicide attempts over 12-month period by study condition|||count of suicide attempts|||Number
2628875|NCT01872338|Primary|Suicide Event|"The investigators define event broadly as a range of suicidal behaviors defined according to the VA's Self-Directed Violence Classification System (SDVCS). Based on the SDVCS, an event may include self-directed violence, with or without injury, in which evidence of suicidal intent is clear or undetermined; or suicidal preparatory behaviors. The study definition of a suicide event also includes suicidal ideation resulting in the need for emergency care or psychiatric hospitalization."|12-months post-baseline|Total number of suicidal events within the 12-month observation period by study condition.|||count of events|||Number
2628876|NCT01872078|Primary|Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7|Change-from-baseline of luteinising hormone area under the concentration-time curve from time zero to 8 hours postdose [AUC(0-8)] at Day 7|Day 7||||Ratio||95% Confidence Interval|Geometric Mean
2628877|NCT01871870|Secondary|Deviation From Target Blood Glucose|Assessment of how accurately the algorithm controls glycemia in the subjects will be carried out using the mean deviation from the target blood glucose (mg/dL). Deviation is measured as algorithm controlled glucose level minus target glucose level.|28 hours||||mg/dl||Standard Deviation|Mean
2628878|NCT01871870|Primary|Verification of the Automation and Telemetry Components|This outcome will verify afferent signal transmittal from the Dexcom sensors to the algorithm and the efferent signal transmittal from the algorithm to the insulin and glucagon pumps. Outcome measure is the average number of sensor and/or pump telemetry failures per 28 hour study.|28 hours||||failures||Standard Deviation|Mean
2628879|NCT01871805|Secondary|Change From Baseline in EORTC Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13): Phase II|EORTC QLQ-LC13 consisted of 13 questions for dyspnea (3 items) and 10 single items (cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm/shoulder, other pain). Questions used 4-point scale (1 'Not at all' to 4 'Very much'). Scores were averaged and transformed to 0-100 scale; higher score=better level of functioning, lower score indicates lower level of functioning. 'Baseline' category for any parameter below represents absolute data at baseline.|Baseline, Weeks 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 105, 111, 117, last visit (up to 194 weeks)|Phase II safety population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at the specified timepoint.|||units on a scale||Standard Deviation|Mean
2628880|NCT01871805|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30): Phase II|EORTC QLQ-C30 included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to lie between 0-100 scale; for each of the symptom scales, higher score=better level of functioning, lower score indicates lower level of functioning. 'Baseline' category for any parameter below (e.g. Global health status/QoL [quality of life]) represents absolute data at baseline. QoL=quality of life|Baseline, Weeks 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 105, 111, 117, last visit (up to 194 weeks)|Phase II safety population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at the specified timepoint.|||units on a scale||Standard Deviation|Mean
2628881|NCT01871805|Secondary|Ctrough After Multiple Dose of Alectinib: Phase II||Pre-dose (0 hour) on Day 1 of Cycles 2, Cycle 3, Cycle 4, Cycle 5 (1 cycle = 21 days)|Phase II PK evaluable population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at the specified timepoint.|||ng/mL||Standard Deviation|Mean
2628882|NCT01871805|Secondary|AUC From Time Zero to Last Measurable Concentration (AUClast) After Multiple Dose of Alectinib: Phase I||Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8 and 10 hours post-dose on Cycle 2 Day 1 (1 cycle = 21 days)|Phase I PK evaluable population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||hour*ng/mL||Standard Deviation|Mean
2628883|NCT01871805|Secondary|Area Under the Plasma Concentration (AUC) Versus Time Curve Extrapolated to Infinity (AUCinf) After Single Dose of Alectinib: Phase I|AUCinf = AUC from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0- t) plus AUC (t-inf).|Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 24, 32 and 48 hours post-dose on Cycle 1 Day -3 (1 cycle = 21 days)|Phase I PK evaluable population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||hour*ng/mL||Standard Deviation|Mean
2628884|NCT01871805|Secondary|Cmax After Multiple Dose of Alectinib: Phase I||Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8 and 10 hours post-dose on Cycle 2 Day 1 (1 cycle = 21 days)|Phase I PK evaluable population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2628885|NCT01871805|Secondary|Maximum Observed Plasma Concentration (Cmax) After Single Dose of Alectinib: Phase I||Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 24, 32 and 48 hours post-dose on Cycle 1 Day -3 (1 cycle = 21 days)|Phase I pharmacokinetic (PK) evaluable population included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2628886|NCT01871805|Secondary|Percentage of Participants With CNS Progression According to RANO Criteria by IRC: Phase II|CNS disease progression was defined as a new CNS lesion or progression of pre-existing CNS lesions according to RANO criteria. As per RANO criteria, progression was defined as 25% or more increase in SPD of measurable enhancing (measurable) compared to the best response after initiation of therapy or Screening; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease).|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Data were not estimable due to low number of responders and longer observation time.||||||
2628887|NCT01871805|Secondary|Percentage of Participants With CNS Progression According to RECIST v1.1 by IRC: Phase II|CNS disease progression was defined as a new CNS lesion or progression of pre-existing CNS lesions according to RECIST v1.1. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II safety population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2628888|NCT01871805|Secondary|CDOR According to RANO Criteria by IRC: Phase II|CDOR was defined as the time from the first observation of a CNS response of CR or PR according to RANO criteria until first observation of CNS progression or death from any cause. An analysis by RANO criteria was performed. Definitions of CR or PR as per RANO was included in description of Outcome Measure 17. As per RANO criteria, progression was defined as 25% or more increase in SPD of measurable enhancing (measurable) compared to the best response after initiation of therapy or Screening; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease) and clear worsening of neurological status with respect to the previous timepoint. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II safety population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2628889|NCT01871805|Secondary|CNS Duration of Response (CDOR) According to RECIST v1.1 by IRC: Phase II|CDOR was defined for CNS responders as the time from the first observation of a CNS response of CR or PR until first observation of CNS progression or death from any cause. An analysis by IRC using RECIST v1.1 was performed. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions. CR was defined as disappearance of all CNS lesions. PR was defined as >=30% decrease in the sum of diameters of measurable CNS lesions (taking as reference the baseline sum of diameters). The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II safety population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2628890|NCT01871805|Secondary|Percentage of Participants With COR According to Response Assessment in Neuro-Oncology (RANO) Criteria by IRC: Phase II|CORR was defined as the percentage of participants who had a CR or PR according to RANO criteria of the baseline CNS lesions. As per RANO criteria, CR was defined as disappearance of all enhancing measurable and non-measurable disease, and no new lesions along with stable or clinically improved status, participants off corticosteroids (or on physiologic replacement doses only) and stable or improved non enhancing T2/FLAIR lesions; PR was defined as 50% or more decrease in sum of the products of the diameters (SPD) of measurable enhancing measurable lesions, no new lesion along with stable or clinically improved status, participants off corticosteroids (or on physiologic replacement doses only) and no progression of non-measurable disease (enhancing and non-enhancing T2/FLAIR lesions. Clopper-Pearson method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II safety population. ‘Overall Number of Participants Analyzed’ = participants with measurable CNS lesions at baseline according to RANO criteria by IRC.|||percentage of participants||95% Confidence Interval|Number
2628891|NCT01871805|Secondary|Percentage of Participants With Central Nervous System Objective Response (COR) According to RECIST v1.1 by IRC: Phase II|COR rate (CORR) was defined as the percentage of participants who had a CR or PR of the baseline central nervous system (CNS) lesions, based on RECIST v.1.1. CNS responses according to RECIST v1.1 did not have to be confirmed. CR was defined as disappearance of all CNS lesions. PR was defined as >=30% decrease in the sum of diameters of measurable CNS lesions (taking as reference the baseline sum of diameters). 95% CI was computed using the Clopper-Pearson method.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II safety population. ‘Overall Number of Participants Analyzed’ = participants with measurable CNS lesions at baseline based on RECIST v1.1 according to IRC.|||percentage of participants||95% Confidence Interval|Number
2628926|NCT01871532|Secondary|Percentage of Cycles With Multifollicular Development|The multifollicular development was defined as the number of cycles with multifollicular development of three or more follicles greater than or equal to 14 millimeter|Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
2640471|NCT01754402|Secondary|Progression Free Survival|The time elapsed for patients between initiation of study therapy and either disease progression or death|up to 2 years|||||||
2628892|NCT01871805|Secondary|DOR According to RECIST v1.1 by Investigator: Phase II|"DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression (according to RECIST v1.1) or death (whichever occurred first). Participants who did not progress or did not die after they had a response were censored at date of their last tumor measurement. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer Outcome Measure 2 for the definition of CR and PR. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI."|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II RE population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2628893|NCT01871805|Secondary|DOR According to RECIST v1.1 by IRC: Phase II|"DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression (according to RECIST v1.1) or death (whichever occurred first). Participants who did not progress or did not die after they had a response were censored at date of their last tumor measurement. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer Outcome Measure 2 for the definition of CR and PR. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI."|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II RE population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2628894|NCT01871805|Secondary|Overall Survival (OS) Time: Phase II|OS was defined as the time between date of first dose and date of death due to any cause. Participants without an event were censored at the date last known to be alive. Participants without any follow-up information were censored at the date of first dose. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.|Baseline up to death (any cause) (maximum follow up 284 weeks)|Phase II safety population|||months||95% Confidence Interval|Median
2628895|NCT01871805|Secondary|Percentage of Participants Who Died Due to Any Cause: Phase II||Baseline up to death (any cause) (maximum follow up 284 weeks)|Phase II safety population|||percentage of participants|||Number
2628896|NCT01871805|Secondary|PFS According to RECIST v1.1 by Investigator: Phase II|PFS was defined as the time between first dose of alectinib and date of first documented disease progression according to RECIST v1.1 or death, whichever occurred first. Participants who have neither progressed nor died at the time of the last clinical cut-off or who lost to follow-up were censored at the date of the last tumor assessment showing no progression of disease either during the study treatment or during follow-up. Participants with no post-baseline assessments were censored at the date of first dose. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II RE population|||months||95% Confidence Interval|Median
2628897|NCT01871805|Secondary|Percentage of Participants With Disease Progression According to RECIST v1.1 by Investigator or Death : Phase II|Percentage of participants with disease progression according to RECIST v1.1 by investigator is defined as the participants with at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II safety population|||percentage of participants|||Number
2628898|NCT01871805|Secondary|Progression-Free Survival (PFS) According to RECIST v1.1 by IRC: Phase II|PFS was defined as the time between first dose of alectinib and date of first documented disease progression according to RECIST v1.1 or death, whichever occurred first. Participants who have neither progressed nor died at the time of the last clinical cut-off or who lost to follow-up were censored at the date of the last tumor assessment showing no progression of disease either during the study treatment or during follow-up. Participants with no post-baseline assessments were censored at the date of first dose. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II safety population|||months||95% Confidence Interval|Median
2628899|NCT01871805|Secondary|Percentage of Participants With Disease Progression According to RECIST v1.1 by IRC or Death : Phase II|Percentage of participants with disease progression according to RECIST v1.1 by IRC is defined as the participants with at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II safety population|||percentage of participants|||Number
2628927|NCT01871532|Secondary|Percentage of Cycles With Bifollicular Development|The bifollicular development was defined as the number of cycles with bifollicular development of only two follicles greater than or equal to 17 millimeter.|Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
2630042|NCT01856686|Primary|Comission Errors at 3 Months|comission errors during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.(Test duration: 22 minutes)|3 months||||errors||Standard Deviation|Mean
2628900|NCT01871805|Secondary|Percentage of Participants With Disease Control According to RECIST v1.1 by Investigator: Phase II|Disease control rate assessed according to RECIST v1.1 was defined as the percentage of participants with a best overall response of CR, PR, or stable disease (SD) lasting for at least 12 weeks, after the first dose of alectinib. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters on study. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. 95% CI for rate was constructed using Clopper-Pearson method.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II RE population|||percentage of participants||95% Confidence Interval|Number
2628901|NCT01871805|Secondary|Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase II|Percentage of participants with objective response as assessed by Investigator was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST v1.1 criteria. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments >=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% CI.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase II RE population|||percentage of participants||95% Confidence Interval|Number
2628902|NCT01871805|Secondary|Duration of Response (DOR) According to RECIST v1.1 by Investigator: Phase I|"DOR was defined for responders (CR or PR) as the time from when response was first documented, to first documented disease progression (according to RECIST v1.1) or death (whichever occurred first). Participants who did not progress or did not die after they had a response were censored at date of their last tumor measurement. Progressive disease (PD): at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Refer Outcome Measure 2 for the definition of CR and PR. The median time to the event was estimated using the methodology of Kaplan-Meier. Brookmeyer-Crowley method was used to calculate 95% CI. Data for this outcome were reported for 'alectinib 600 mg' and 'alectinib other than 600 mg' groups as planned."|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase I RE population. ‘Overall Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2628903|NCT01871805|Secondary|Percentage of Participants With Objective Response According to RECIST v1.1 by Investigator: Phase I|Percentage of participants with objective response as assessed by Investigator was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of CR or PR based on the RECIST v1.1 criteria. CR: disappearance of all target and non-TLs and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments >=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% CI. Data for this outcome were reported for 'alectinib 600 mg' and 'alectinib other than 600 mg' groups as planned.|Every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter (assessed up to 194 weeks) (1 cycle = 21 days)|Phase I RE population comprised all Phase I participants with measurable disease at baseline who had a baseline tumor assessment and received at least one dose of alectinib.|||percentage of participants||95% Confidence Interval|Number
2628904|NCT01871805|Primary|Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Independent Review Committee (IRC): Phase II|Percentage of participants with objective response as assessed by IRC was defined as the percentage of responders in the response evaluable population, where responders were defined as participants determined to have a best overall response of complete response (CR) or partial response (PR) based on the RECIST v1.1 criteria. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters. CR and PR were to be confirmed by repeat assessments >=4 weeks after initial documentation. Clopper-Pearson method was used to calculate 95% confidence interval (CI).|Cycle 1 Day 1 up to 194 weeks (assessed at every 6 weeks from Cycle 1 Day 1, at Cycles 2, 4, and 6 between Days 14-21, and every 3 cycles thereafter) (1 cycle = 21 days)|Phase II Response evaluable (RE) population comprised all Phase II participants with measurable disease at baseline who had a baseline tumor assessment and received at least one dose of alectinib.|||percentage of participants||95% Confidence Interval|Number
2628905|NCT01871805|Primary|Recommended Phase II Dose (RP2D): Phase I|RP2D was defined as the highest dose with acceptable toxicity as determined from Phase I of the study.|Throughout Cycle 1 of Phase I (21 days)|Phase I safety population|||mg|||Number
2628928|NCT01871532|Primary|Percentage of Cycles With Monofollicular Development|The monofollicular development was defined as the number of cycles with monofollicular development only one Follicle Greater Than or Equal (>= to 17 millimeter (mm) and no other follicles Greater than or equal to 14 mm following up to 4 weeks Gonal-f treatment.|Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
2629052|NCT01870388|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Baricitinib (LY3009104)||Predose up to 48 hours (h) postdose|Participants who received 1 dose of study drug and had evaluable PK data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2628906|NCT01871805|Primary|Number of Participants With Dose Limiting Toxicities (DLTs): Phase I|The DLTs were defined as any which included Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding or Grade 4 neutropenia continuing for greater than equal to (>=) 7 consecutive days, non-hematological toxicity of Grade 3 or higher (excluding transient electrolyte abnormalities, diarrhea, nausea, and vomiting that recovers to Grade 2 or lower with appropriate treatment and participants having Grade 2 aspartate transaminase (AST) and/or alanine transaminase (ALT) at baseline must have Grade 3 AST/ALT for 7 days or Grade 4 AST/ALT to be considered a DLT), and adverse events (AEs) that required suspension of treatment for a total of >=7 days which the Investigator could not rule out as been related to alectinib.|Throughout Cycle 1 of Phase I (21 days)|Phase I safety population|||participants|||Number
2628907|NCT01871558|Secondary|Percent of Participants That Reach Therapeutic Goal (HbA1c ≤ 7%) at Week 24 Without Any Hypoglycaemic Episode (Symptomatic or Not) and Without Any Weight Gain (Variation ≥3% Compared to Baseline)|HbA1c <= 7% without any hypoglycaemic episode (symptomatic or not) and without any weight gain|week 24|ITT population|||percent of participants|||Number
2628908|NCT01871558|Secondary|Percentage of Patients With Severe and Confirmed Hypoglycemic Events|Severe hypoglycemic events (and number of events) , defined as events requiring assistance of a third party, and with confirmed hypoglycemic events (and number of events) defined as events with concomitant self monitoring of blood glucose (SMBG) < 70 mg/dL|24 weeks|ITT population|||percent participants|||Number
2628909|NCT01871558|Secondary|Mean Daily Insulin Dose at Week 24||Week 24|ITT population|||(U/d)||Standard Deviation|Mean
2628910|NCT01871558|Secondary|Change From Baseline in Body Weight in Both Treatment Arms||Baseline, Week 24|Safety Population|||kg||Standard Deviation|Mean
2628911|NCT01871558|Secondary|Change From Baseline in HbA1c to Week 24 in Both Treatment Arms||Baseline, Week 24|ITT population|||HbA1c percent||Standard Deviation|Mean
2628912|NCT01871558|Secondary|Percentage of Patients Reaching Their Glycemic Target Without Hypoglycemic Events|Glycemic target is defined as Glycated hemoglobin(HbA1c) ≤ 7%|24 weeks|ITT population|||percent of participants|||Number
2628913|NCT01871558|Primary|Percentage of Patients Who Reported at Least One Symptomatic Hypoglycemic Event During the 24 Week Randomized Period in Both Treatment Arms||24 weeks|safety population|||percent of participants|||Number
2628914|NCT01871532|Secondary|Sex Hormone Binding Globulin (SHBG) Levels||Baseline|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
2628915|NCT01871532|Secondary|Testosterone Levels||Baseline|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
2628916|NCT01871532|Secondary|Change From Baseline in Anti-Mullerian Hormone (AMH) Levels at Week 4||Baseline, Week 4|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
2628917|NCT01871532|Secondary|Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH) Administered Per Cycle||Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
2628918|NCT01871532|Secondary|Duration of Recombinant Follicle Stimulating Hormone (rFSH) Stimulation||Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
2628919|NCT01871532|Secondary|Number of Subjects With Ovarian Hyper Stimulation Syndrome (OHSS)|OHSS was defined as an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations, classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, hemodynamic and metabolic complications.|up to 42 days post hCG administration|Safety population included all subjects who were randomised and received at least 1 Gonal-f injection.|||subjects|||Number
2628920|NCT01871532|Secondary|Number of Miscarriages After Confirmation of Clinical Pregnancy|Miscarriages were calculated per clinical pregnancy, and clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or confirmed by clinical signs of pregnancy. It excludes ectopic pregnancy.|35-42 days post hCG administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
2628921|NCT01871532|Secondary|Number of Fetuses||35-42 days post hCG administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
2628922|NCT01871532|Secondary|Number of Multiple Pregnancy|Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning—identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals.|35-42 days post hCG administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
2628923|NCT01871532|Secondary|Percentage of Cycles Resulting in Clinical Pregnancy|Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.|35-42 days post hCG administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
2628924|NCT01871532|Secondary|Percentage of Cycles Wherein Human Chorionic Gonadotropin (hCG) Was Not Administered||Baseline up to 4 weeks|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
2628925|NCT01871532|Secondary|Percentage of Ovulatory Cycles|Ovulation was defined as a serum progesterone (P4 ) level greater than or equal to 10 nanogram per milliliter (ng/mL) or Clinical Pregnancy. Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.|Baseline up to 42 days post human chorionic gonadotrophin (hCG) administration|Data was not assessed since the study was terminated early due to the delay in providing additional study drug following a batch recall.||||||
2629121|NCT01869348|Secondary|Change in Sedentary Behavior From Baseline to 12 Weeks|Minutes of total sedentary time measured over a seven day period|12 weeks|||||||
2628929|NCT01871519|Secondary|Neurological Success Rate|Neurological functions were assessed preoperatively and postoperatively. Each of the individual functions was comprised of a number of elements. Investigators evaluated whether observations in each function category was normal or abnormal, and documentation of abnormal findings were required for each element in that function. Success for each component was defined as maintenance or improvement from preoperative for all elements. Success for overall neurologic status was defined as successful in all components.|Pre-discharge, 30 days, 3 months, 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||percentage of participants|||Number
2628930|NCT01871519|Secondary|Subsequent Radiographic Fractures|A subsequent VCF was defined as any fracture at an index or non-index vertebral body occurring after the initial procedure as compared to baseline. The percentage of subjects having one or more subsequent VCFs is presented.|3 months and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||percentage of participants|||Number
2628931|NCT01871519|Secondary|Local Cobb Angle|The local Cobb angle (LCA) was defined as the angle formed by lines drawn parallel to the superior endplate of the vertebral body above and the inferior endplate of the vertebral body below.|Baseline, pre-discharge, 3 months, and 12 months|A total of 490 treated levels in 344 subjects were included in LCA analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||degrees|Treated levels|Standard Deviation|Mean
2628932|NCT01871519|Secondary|Vertebral Body Angle|The vertebral body kyphosis angle (VBA) was defined as the angle formed by lines drawn parallel to the caudal and cranial fractured vertebral body endplates.|Baseline, pre-discharge, 3 months, and 12 months|A total of 490 treated levels in 344 subjects were included in VBA analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||degrees|Treated levels|Standard Deviation|Mean
2628933|NCT01871519|Secondary|Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP)|AHRP (Absolute height restored as percent) was the amount of height restored in the vertebral body expressed as a percent of estimated pre-fracture (EP) height. Measurements were assessed at anterior, medial, and posterior locations on the vertebral body.|Baseline, pre-discharge, 3 months, and 12 months|A total of 490 treated levels in 344 subjects were included in vertebral body height restoration analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||percentage of pre-fracture height|Treated levels|Standard Deviation|Mean
2628934|NCT01871519|Secondary|Karnofsky Performance Scale|For subjects with cancer, the Karnofsky performance scale was used for rating subject activities of daily living.The Karnofsky performance scale rates a subject on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease), and a score of 70 is a clinically meaningful threshold for self-care.|Baseline, 30 days, 3 months 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
2628935|NCT01871519|Secondary|Barthel Index (Only for Subjects With Osteoporosis)|For subjects with osteoporosis, the Barthel index was used for rating subject activities of daily living on a scale from 0 (maximum disability) to 20 (no disability).|Baseline, 30 days, 3 months 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
2628936|NCT01871519|Secondary|Ambulatory Status||Baseline, 7 days, 30 days, 3 months, 6 months, 9 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||percentage of participants|||Number
2628937|NCT01871519|Secondary|The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks;||Baseline, 30 days, 3 months, 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||days||Standard Deviation|Mean
2628938|NCT01871519|Secondary|Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks||Baseline, 30 days, 3 months, 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||percentage of participants|||Number
2628939|NCT01871519|Secondary|Quality of Life by EQ-5D Index Score||Baseline, 30 days, 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
2628940|NCT01871519|Secondary|Quality of Life by SF-36v2 PCS|Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life.|Baseline, 30 days, 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
2628941|NCT01871519|Secondary|Back Function (ODI)|ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|Baseline, 30 days, 6 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
2628942|NCT01871519|Secondary|Back Pain|"Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|Baseline, 7 days, 30 days, 6 months, 9 months, and 12 months|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
2628943|NCT01871519|Primary|Change From Baseline in Quality of Life by the EQ-5D Index at 3 Months|EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.|Baseline, 3 months after surgery|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
2628944|NCT01871519|Primary|SF-36v2 Physical Component Summary Change From Baseline at 3 Months|Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life.|Baseline, 3 months after surgery|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
2628945|NCT01871519|Primary|Back Function Change From Baseline by Oswestry Disability Index at 3 Months|ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).|Baseline, 3 months after surgery|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
2628946|NCT01871519|Primary|Back Pain Change From Baseline at 3 Months|"Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be."|Baseline, 3 months after surgery|The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.|||units on a scale||Standard Deviation|Mean
2628947|NCT01871506|Secondary|Cost-effectiveness|The cost of the standard of care treatment and the cost of the intensive treatment.|6 months|Cost per quit (in dollars) are shown below.|||dollars||95% Confidence Interval|Mean
2628948|NCT01871506|Secondary|The Number of IT Participants Who Took 1-3 Monthly Booster Sessions|The number of IT participants who took 1-3 monthly booster sessions of smoking cessation counseling|Treatment Initiation to 6 Month Follow-up|Only assessed intensive treatment arm|||Participants|||Count of Participants
2628949|NCT01871506|Secondary|The Number of IT Participants Who Took 1-2 4-week Refills|The number of intervention participants who took 1-2 4-week refills of smoking cessation medication|Treatment Initiation to 6 Month Follow-up|Only assessed intensive treatment arm|||Participants|||Count of Participants
2628950|NCT01871506|Secondary|The Number of IT Participants Who Used Smoking Cessation Counseling|The number of intervention participants who used smoking cessation counseling during the study (Y/N)|Treatment Initiation to 6 Month Follow-up|Only assessed intensive treatment arm|||Participants|||Count of Participants
2628951|NCT01871506|Secondary|The Number of IT Participants Who Used Smoking Cessation Pharmacotherapy|The number of IT participants who used 1) smoking cessation pharmacotherapy (Y/N dispensed) 2) smoking cessation counseling (Y/N), 3) 1-2 4-week refills, 4) took 1-3 monthly booster sessions.|Treatment Initiation to 6 month follow-up|Only assessed intensive treatment arm.|||Participants|||Count of Participants
2628952|NCT01871506|Secondary|Number of Participants With Self-reported 7-day Point Prevalence.|Number of Participants with Self-reported smoking abstinence of at least 7 days|6 months|Twenty participants were too ill or deceased to complete follow-up assessment. Given the study participant population of cancer patients, our trial was powered accounting for cancer deaths and reporting participants who were alive at follow-up assessment.|||Participants|||Count of Participants
2628953|NCT01871506|Secondary|Number of Participants With Sustained Tobacco Abstinence|Number of Participants with Biochemically confirmed repeated point prevalence abstinence at 3 & 6 months|6 months|Twenty participants were too ill or deceased to complete follow-up assessment. Given the study participant population of cancer patients, our trial was powered accounting for cancer deaths and reporting participants who were alive at follow-up assessment.|||Participants|||Count of Participants
2628954|NCT01871506|Secondary|Number of Participants With Continuous Tobacco Abstinence|Number of Participants with Continuous tobacco abstinence (between quit and follow-up) at 3 & 6 months|3 months to 6 months|Twenty participants were too ill or deceased to complete follow-up assessment. Given the study participant population of cancer patients, our trial was powered accounting for cancer deaths and reporting participants who were alive at follow-up assessment.|||Participants|||Count of Participants
2628955|NCT01871506|Secondary|Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 3 Months|Number of participants with7 -day point-prevalence tobacco abstinence at 3-month follow-up, assessed by biochemically confirmed saliva cotinine (<15 ng/ml76, 82) or <10 ppm expired air carbon monoxide (CO) for participants concurrently using NRT|3 months|Twenty participants were too ill or deceased to complete follow-up assessment. Given the study participant population of cancer patients, our trial was powered accounting for cancer deaths and reporting participants who were alive at follow-up assessment.|||Participants|||Count of Participants
2628956|NCT01871506|Primary|Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 6 Months|Number of participants with 7-day point-prevalence tobacco abstinence at 6-month follow-up, assessed by biochemically confirmed saliva cotinine (<15 ng/ml76, 82) or <10 ppm expired air carbon monoxide (CO) for participants concurrently using NRT|6 months|Twenty participants were too ill or deceased to complete follow-up assessment. Given the study participant population of cancer patients, our trial was powered accounting for cancer deaths and reporting participants who were alive at follow-up assessment.|||Participants|||Count of Participants
2629122|NCT01869348|Primary|Change in Physical Activity From Baseline to 12 Weeks|Minutes of physical activity measured over a seven day period|12 weeks||||minutes||Standard Deviation|Mean
2628957|NCT01871441|Secondary|The Rates of Grade III-IV GVHD in Female Recipients With Male Donors Will be Computed With Corresponding Exact Binomial 95% Confidence Intervals.|The difference in DFS in recipient-donor combinations in which there is at least 1 KIR ligand mismatch versus those without a KIR ligand mismatch will be tested using log-rank test.|Up to 1 year|No data were collected or analyzed.||||||
2628958|NCT01871441|Secondary|Rate of Grade III-IV GVHD in Female Recipients With Male Donors|The rates of grade III-IV GVHD in female recipients with male donors will be computed with corresponding exact binomial 95% confidence intervals.|Up to 1 year|No data were collected or analyzed.||||||
2628959|NCT01871441|Secondary|Number of Participants With Relapse of Disease|Relapse of Disease is defined as the return of a disease or the signs and symptoms of a disease after a period of improvement. Relapse is almost always associated with the immunological failure of the donor immune system to recognize and/or respond to reemergence of a tumor. The number of participants with relapse of disease will be collected.|Up to 1 year||||Participants|||Count of Participants
2628960|NCT01871441|Primary|Number of Participants With Disease-free Survival (DFS)|Disease free survival (DFS), defined as the time to death, relapse or disease progression.|1 year||||Participants|||Count of Participants
2628961|NCT01871402|Other Pre-specified|Change in % Body Surface Area (BSA) With Active Psoriasis at Days 8 and 15|The investigator will use the assumption that 1% BSA is approximately equal to the surface area of the subject's palm and fingers, with the fingers extended yet grouped together, creating a flat oval-like surface area.|Baseline, Day 8 and Day 15|Analysis shown is based on the ITT population at Days 8 and 15 and compared to baseline. Number of Participants Analyzed is at Day 15; at Day 8, N=109 (Active) and N=110 (Vehicle). Only participants with observed values are reported.|||Change in %BSA||Standard Deviation|Mean
2628962|NCT01871402|Other Pre-specified|Change From Baseline in Pruritus Score at Day 15|Pruritus scale will be used to assess the subjective and multidimensional experience of the subject's pruritus (itching) during the previous two weeks at Baseline and Day 15. Possible scores range from 5 (no pruritus) to 25 (most severe pruritus).|Baseline and Day 15|Analysis shown is based on the ITT population. Only participants with observed values are reported.|||units on a scale||Standard Deviation|Mean
2628963|NCT01871402|Other Pre-specified|"Proportion of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis at Day 8"|"Interim analysis of clinical signs of psoriasis (scaling, erythema and plaque elevation). Treatment success and clinical signs as defined in the secondary outcome measure."|Day 8|Analysis shown is based on the ITT population. Only participants with observed values are reported.|||percentage of participants|||Number
2628964|NCT01871402|Other Pre-specified|"Proportion of Subjects With IGA Treatment Success at Day 8"|"Interim analysis of IGA. Treatment success and IGA as defined in the primary outcome measure."|Day 8|Analysis shown is based on the ITT population. Only participants with observed values are reported.|||percentage of participants|||Number
2628965|NCT01871402|Secondary|"Proportion of Subjects Rated a Treatment Success for Each of the Clinical Signs of Psoriasis (Scaling, Erythema and Plaque Elevation)"|"A static assessment of the overall or average degree of severity of each of three key characteristics present within all of the subject's psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. Each clinical sign of psoriasis is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 15|Analysis shown is based on the ITT population.|||percentage of participants|||Number
2628966|NCT01871402|Primary|"Proportion of Subjects Rated a Treatment Success Based on the Investigator's Global Assessment (IGA)"|"The IGA score is a static evaluation of the overall or average degree of severity of a subject's disease, taking into account all of the subject's psoriatic lesions. Treatment success is defined as a score of 0 or 1 representing cleared or almost cleared at Day 15 with at least a two grade decrease in severity score relative to Baseline. IGA is measured on a 5-point scale, ranging from 0 (clear) to 4 (severe/very severe)."|Day 15|Analysis shown is based on the Intent-to-Treat population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.|||percentage of participants|||Number
2628967|NCT01871285|Primary|Change From Baseline in Maximum COWS Total Score|Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The change from baseline in maximum COWS total score is determined as the difference between the maximum COWs total score and the baseline COWs total score.|Pre-dose (-0.5; baseline), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of 2 treatment periods); 4 subjects were excluded.|||score||Standard Deviation|Mean
2628968|NCT01871285|Primary|Maximum COWS Total Score|Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal. The maximum COWs total score is defined as the maximum COWs total score across all time points during the corresponding treatment period after study drug administration for each subject.|Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of 2 periods); 4 subjects were excluded.|||score||Standard Deviation|Mean
2629024|NCT01870778|Primary|Percentage of Participants With Confirmed Cardiovascular (CV) Death Through Day 180|The percentage of participants with an adjudicated CV death through day 180 was assessed.|180 days|The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.|||Percentage of participants|||Number
2628969|NCT01871285|Secondary|"Change From Baseline in Pain Now Over Time Using NRS"|Subject rating of pain intensity using 11-point numerical rating scale (NRS) where 0=no pain and 10=pain as bad as you can imagine.|Pre-dose (-0.5; baseline), 0.5, 1, 2, 4, 9, 12, 12.5, 13, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of the 2 treatment periods); 4 subjects excluded.|||units on a scale||Standard Deviation|Mean
2628970|NCT01871285|Secondary|Change From Baseline in COWS Total Score Over Time|Investigator-rated COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal.|Pre-dose (-0.5; baseline), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of 2 treatment periods); 4 subjects were excluded.|||score||Standard Deviation|Mean
2628971|NCT01871285|Primary|Number of Responders|A responder is defined as a subject whose maximum (across all time points) clinical opiate withdrawal scale (COWS) total score is ≥13. COWS scores range 0 to 4 or 5 on 11 items related to opiate withdrawal signs or symptoms; total score range 0 to 48 where 0-4 = no withdrawal and 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, more than 36 = severe withdrawal.|Pre-dose (-0.5), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 9, 12, 12.5, 13, 13.5, 14, 16, and 24 (or end of study visit) hours post 1st study drug dose on each day of administration (period 1 [day 1] and period 2 [day 2]) in each treatment sequence|Analysis based on Per-protocol population (all randomized subjects who did not have major protocol deviations that might have confounded interpretation of the COWS [eg, received erroneous treatment], completed both crossover periods, and provided at least the first 4 hours of COWS data for each of the 2 treatment periods); 4 subjects were excluded.|||participants|||Number
2628972|NCT01871142|Secondary|Secondary Objective Safety and Tolerability|To assess the safety and tolerability of single, escalating oral doses of Aes-103 compared with placebo in healthy adult men at rest and during stationary cycle ergometer exercise in normoxia and hypoxia by monitoring adverse events (AEs), electrocardiograms (ECGs), blood pressure, blood oxygen saturation.|AEs will be monitored at the time of visit and during the follow up period of 7 to 14 days.||||participants|||Number
2628973|NCT01871142|Primary|Primary Objective Endurance Exercise Performance|To quantify endurance exercise performance (time trial performance during stationary cycle ergometer exercise) in healthy adult men in four conditions: normoxia (normal oxygen; fraction of inspired oxygen = 0.21) following oral placebo consumption, hypoxia (low oxygen; fraction of inspired oxygen = 0.15) following oral placebo consumption, hypoxia following oral consumption Aes-103 (1000 mg) and hypoxia following oral consumption Aes-103 (3000 mg).|The time trial will begin after 1 hour after consumption of the intervention or placebo under normoxic or hypoxic conditions.||||minutes||Standard Error|Mean
2628974|NCT01871090|Other Pre-specified|Length of Emergency Department Stay|Defined as the time from the Emergency Department Check In Time until the Emergency Department Check Out Time (discharged/leaves Emergency Department or admitted to hospital).|On day of Emergency Department admission||||Minutes||Full Range|Median
2628975|NCT01871090|Secondary|Time to Clinical/Treatment Decision|Defined as the time from the Emergency Department Check In Time until the first of: Time of Clinical/Treatment Decision or Emergency Department Check Out Time (discharged/leaves Emergency Department or admitted to hospital).|On day of Emergency Department admission||||Minutes||Full Range|Median
2628976|NCT01871090|Primary|Time to Interrogation|Time to interrogation is defined as the time from Triage (decision to interrogate the device) until the first of: Completion of interrogation, Time of Clinical/Treatment decision, or Emergency Department check out time.|On day of Emergency Department admission||||Minutes||Full Range|Median
2628977|NCT01871077|Secondary|Number of Cases With Adverse Events|The presence of adverse events was evaluated by the number of cases.|11 days|the statistical analysis was performed by protocol|||cases|eyes||Number
2628978|NCT01871077|Secondary|Number of Eyes With Epithelial Defects|the number of epithelial defects was evaluated by the application of fluorescein, Staining was performed with fluorescein which stained the degenerated cells and the mucus filaments present in the tear film.|11 days|the statistical analysis was performed by protocol|||eyes|eyes||Number
2628979|NCT01871077|Secondary|Intraocular Pressure (IOP)|The tension of a healthy eye should be between 10 and 20 millimeters of mercury (mmHg). In Goldman-type Applying Tonometry, the cornea is flattened, and the intraocular pressure is determined by measuring the force of application and the flattened area.|11 days|the analysis of the study population was by protocol with Wilcoxon test|||mmHg|eyes|Standard Deviation|Mean
2628980|NCT01871077|Primary|Visual Acuity (VA)|"The VA will be evaluated basally, without refractive correction with the Snellen chart. A Snellen chart is placed at a standard distance: 20 ft. At this distance, the symbols on the line representing normal acuity subtend. This line, designated 20/20 is the smallest line that a person with normal acuity can read at a distance of 20fs. the scale consists of 11 lines of letters of different size, the size of the letter gives a fractional value according to the visual acuity of the patient, the value is inversely proportional to the visual acuity, if the denominator is greater the visual acuity will be less.~Line 1: 20/200 Line 2: 20/100, Line 3: 20/70, line 4: 20/50, line 5: 20/40, Line 6: 20/30, line 7: 20/25, Line 8: 20/20, line 9: 20/15, line 10: 20/13, line 11: 20/10.~the results will be expressed as the mean of the denominator of the Snellen scale (scale 20/--) example. 18.5 ± 1.5, that means the final result is 20/18.5 ± 1.5"|11 days|the analysis by treatment of the research subjects was carried out|||score on a scale|eyes|Standard Deviation|Mean
2628981|NCT01870999|Secondary|"Number of Participants Hospitalized for Adverse Event Worsening Schizophrenia"|"The number of participants hospitalized for the Adverse Event Worsening Schizophrenia included all participants who were hospitalized for any Adverse Event pertaining to the exacerbation of schizophrenic symptoms."|7 Months|All randomized participants were included in the analysis population.|||Participants|||Number
2628982|NCT01870999|Secondary|Clinical Global Impression-Improvement Scale (CGI-I) at Week 12 and Week 24|"The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: Compared to his/her condition at baseline (prior to randomization), how much has the patient changed? using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement."|Baseline, Week 12, Week 24|All randomized participants with data available at the given time-point were included in this analysis population.|||units on a scale||Standard Deviation|Mean
2628983|NCT01870999|Secondary|Change From Baseline in the Clinical Global Impression- Severity of Illness Score (CGI-S) at Week 12 and Week 24|"The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? using an 8-point scale where 0=not assessed to 7=among the most extremely ill patients. A negative change from Baseline indicated improvement."|Baseline, Week 12, Week 24|All randomized participants with data available were included in this analysis population (LOCF).|||units on a scale||Standard Deviation|Mean
2628984|NCT01870999|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Negative Subscale Scores at Week 12 and Week 24|The PANSS Negative Subscale consisted of 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Severity was rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Negative Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A negative change from Baseline indicated improvement.|Baseline, Week 12, Week 24|All randomized participants with data available were included in this analysis population (LOCF).|||units on a scale||Standard Deviation|Mean
2628985|NCT01870999|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Positive Subscale Scores at Week 12 and Week 24|The PANSS Positive Subscale consisted of 7 symptom constructs: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Severity was rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Positive Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A Negative change from Baseline indicated improvement.|Baseline, Week 12, Week 24|All randomized participants with data available were included in this analysis population (LOCF).|||units on a scale||Standard Deviation|Mean
2628986|NCT01870999|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 and Week 24|The PANSS consisted of 3 subscales with a total of 30 symptom constructs each rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The Positive Subscale consisted of 7 positive symptom constructs with a possible subscale score of 7 to 49, the Negative Subscale consisted of 7 negative symptom constructs with a possible subscale score of 7 to 49 and the General Psychopathology Subscale consisted of 16 symptom constructs for a possible subscale score of 16 to 112. The PANSS Total Score ranged from 30 (best) to 210 (worst; indicating more severe symptoms). A Negative change from Baseline indicated improvement.|Baseline, Week 12, Week 24|All randomized participants with data available were included in this analysis population-last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2628987|NCT01870999|Secondary|Dehydro-aripiprazole Maximum (Peak) Plasma Concentration (Tmax)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for tmax were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.|||Day||Full Range|Median
2628988|NCT01870999|Secondary|Dehydro-aripiprazole Area Under the Concentration-Time Curve at Steady-State (AUCτ)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule during each dosing interval from 0 to 1344 hours post-dose.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.|||μg*h/mL||Standard Deviation|Mean
2628989|NCT01870999|Secondary|Dehydro-aripiprazole Minimum Steady State Plasma Concentration (Css,Min)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for Css,min were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.|||ng/mL||Standard Deviation|Mean
2628990|NCT01870999|Secondary|Dehydro-aripiprazole Maximum Steady State Plasma Concentration (Css,Max)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for dehydro-aripiprazole. Values for Css,max were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set.|||ng/mL||Standard Deviation|Mean
2629025|NCT01870739|Secondary|Number of Patients With Reported Adverse Events, Serious Adverse Events and Death|This outcome measure summarizes patients with any adverse events, serious adverse events and death.|12 weeks|Safety analysis set: All patients that received study drug|||Patients|||Number
2629123|NCT01869192|Secondary|Pathological Response|Pathological response (pCR or microscopic only primary) in both primary and nodes using the Miller-Payne criteria for pathologic response.|Up to 8 months||||Participants|||Count of Participants
2628991|NCT01870999|Secondary|Aripiprazole Terminal-phase Elimination Half-life (t1/2,z)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for t1/2,z were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set. The analysis population for this outcome measure represents a sub-set who were evaluable for this measure at month 5.|||Day||Standard Deviation|Mean
2628992|NCT01870999|Secondary|Aripiprazole Steady-state Plasma Concentration (Css,Avg)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,avg were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set. Data was missing for 1 patient in the 300 mg Aripiprazole IM Depot arm.|||ng/mL||Standard Deviation|Mean
2628993|NCT01870999|Secondary|Aripiprazole Maximum (Peak) Plasma Concentration (Tmax)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for tmax were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set.|||Day||Full Range|Median
2628994|NCT01870999|Primary|Aripiprazole Area Under the Concentration-time Curve at Steady-state (AUCτ)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule during each dosing interval from 0 to 1344 hours post-dose.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 3rd or 4th dose are included in the efficacy pK analysis set. Data was missing for 1 patient in the 300 mg Aripiprazole IM Depot arm.|||μg*h/mL||Standard Deviation|Mean
2628995|NCT01870999|Primary|Aripiprazole Minimum Steady State Plasma Concentration (Css,Min)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,min were determined directly from the observed data at 672 hours after the fifth monthly injection.|672 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set. Data was missing for 1 patient in the 200 mg Aripiprazole IM Depot arm.|||ng/mL||Standard Deviation|Mean
2628996|NCT01870999|Primary|Aripiprazole Maximum Steady State Plasma Concentration (Css,Max)|Blood samples were collected for pharmacokinetic parameters pre-dose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 264, 336, 504, 672, 1008 and 1344 hours post-dose and were analyzed for aripiprazole. Values for Css,max were determined directly from the observed data during the dosing interval (0-1344 hours) after the fifth monthly injection.|Pre-dose and 1 to 1344 hours post-dose at Month 5|Participants who received at least 3 doses of study medication and had pharmacokinetic (pK) samples collected through at least 672 hours following the 5th dose are included in the efficacy pK analysis set.|||ng/mL||Standard Deviation|Mean
2628997|NCT01870999|Primary|Number of Participants With Adverse Events as a Measure of Safety|Safety and tolerability was assessed by the number of participants with adverse events (AE). An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject while enrolled in the study, whether or not it was considered drug-related by the investigator. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (ie, clinically significant) change from baseline for that individual participant.|7 Months|Participants who received at least one dose of study medication are included in the safety analysis set.|||Participants|||Number
2628998|NCT01870973|Primary|Percent of Patients With Success as Defined by no or Mild Pain as Analyzed on a VAS Scale and no Narcotic Use|"pain measurement as assessed on a visual analog scale and pain medication usage~definition of success = no or mild pain as analyzed on VAS scale and no narcotic use; analyzed by logistic regression~VAS scale is 0 to 170 mm with the higher numbers indicating more pain and less success."|each day for 5 days||||percentage of participants|||Number
2628999|NCT01870921|Secondary|Major CV Events|Combination of CV death, MI, and stroke|12 months||||Participants|||Number
2629000|NCT01870921|Primary|Serious Adverse Events Other Than Bleeding|SAEs except the blending events which have aleady been reported as SAEs.|12 months||||Participants|||Number
2629001|NCT01870921|Primary|Bleeding Events|PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal|12 months||||Participants|||Number
2629002|NCT01870856|Secondary|Stage 2: Change From Baseline in Ocular Discomfort Score (as Measured by SPEED) at 2 Weeks|This outcome measure was not evaluated since primary efficacy was not demonstrated.|Baseline, Week 2|||||||
2629003|NCT01870856|Primary|Stage 2: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks|This outcome measure was not evaluated since primary efficacy was not demonstrated.|Baseline, Week 2|||||||
2629004|NCT01870856|Primary|Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks|LWE was measured by slit lamp evaluation of fluorescein and lissamine green staining of the upper eyelid. LWE was graded on a scale from 0 to 3, where 0=none and 3=severe. The percent of eyes experiencing at least a 1 grade reduction in LWE (from baseline) at the 2-week visit was compared between groups. One eye (study eye) contributed to the analysis.|Baseline, Week 2|This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan. Denominator for percentages is the number of subjects with data available at both time points.|||percentage of subjects|||Number
2629005|NCT01870843|Secondary|Remission Rate Based on Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) up to Day 56|QIDS-SR contains 16 question regarding 9 Major depression disorder symptoms (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Each question is rated on a 4-point scale (range, 0 to 3). Total score is the sum of scores calculated by adding scores for each question and the interpretation is as follows: 0-5 (no depression likely); 6-10 (possibly mildly depressed); 11-15 (moderate depression); 16-20 (severe depression); 21-27 (very severe depression). Higher scores represent more severe depression symptoms data was obtained by Last observation carried forward (LOCF) method.|Day 7, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."|||Percentage of participants||95% Confidence Interval|Number
2629006|NCT01870843|Secondary|Remission Rate Based on Hamilton Anxiety Scale (HAM-A) up to Day 56|"HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5 point scale, ranging from 0 (not present) to 4 (severe). Total score is calculated by adding the scores for each of the 14 items and the score ranges from 0 to 56. The interpretation of total scores are: 0 to 17 is considered to be mild, 18 to 25 mild to moderate, and 26 to 30 moderate to severe and 31 to 56 indicate very severe anxiety. Higher scores indicate worsening data was obtained by Last observation carried forward (LOCF) method."|Day 7, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."|||Percentage of participants||95% Confidence Interval|Number
2629007|NCT01870843|Secondary|Depression Response Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56|"The MADRS is a 10 item scale designed to measure depression severity. Each item is scored on a 7 point scale and the scores range from 0 = item not present/normal to 6 = severe/continuous presence of the symptoms. Total score is calculated by adding the scores for all the 10 items and ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; 35 to 60= severe depression data was obtained by Last observation carried forward (LOCF) method."|Day 7, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."|||Percentage of participants||95% Confidence Interval|Number
2629008|NCT01870843|Secondary|Change in Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) Total Scores From Baseline up to Day 56|QIDS-SR contains 16 question regarding 9 Major depression disorder symptoms (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Each question is rated on a 4-point scale (range, 0 to 3). Total score is the sum of scores calculated by adding scores for each question and the interpretation is as follows: 0-5 (no depression likely); 6-10 (possibly mildly depressed); 11-15 (moderate depression); 16-20 (severe depression); 21-27 (very severe depression). Higher scores represent more severe depression symptoms.|Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56|Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period.|||Units on a scale||95% Confidence Interval|Mean
2629009|NCT01870843|Secondary|Change in Hamilton Anxiety Scale (HAM-A) Total Scores From Baseline up to Day 56|"HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe). Total score is calculated by adding the scores for each of the 14 items and the score ranges from 0 to 56. The interpretation of total scores are: 0 to 17 is considered to be mild, 18 to 25 mild to moderate, and 26 to 30 moderate to severe and above 30 indicate very severe anxiety. Higher scores indicate worsening."|Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56|Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period.|||Units on a scale||95% Confidence Interval|Mean
2629010|NCT01870843|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline up to Day 56|"The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on a 7-point scale and the scores range from 0 = item not present/normal to 6 = severe/continuous presence of the symptoms. Total score is calculated by adding the scores for all the 10 items and it ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression."|Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56|Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period.|||Units on a scale||95% Confidence Interval|Mean
2629011|NCT01870843|Secondary|Treatment Improvement Rate at the End of Week 1 and Week 2|"Onset of effect is defined as the reduction rate greater than or equal to 20 percent change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total scores. The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on 7-point scale, from 0 = not present/normal to 6 = severe/continuous presence of the symptoms and the total score (addition of all 10-items) ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression."|Week 1 and Week 2|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."|||Participants|||Number
2629037|NCT01870726|Secondary|Pharmacokinetic Profile of Buparlisib - T1/2|Plasma concentration profile of INC280 in combination with Buparlisib. T1/2 is the terminal half life|Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months|Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile.|||hr||Full Range|Median
2630043|NCT01856686|Primary|Omission Errors at 3 Months|Omission errors during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach. (Test duration: 22 minutes)|3 months||||errors||Standard Deviation|Mean
2629012|NCT01870843|Secondary|Remission Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56|"Remission rate is defined as percentage of participants with MADRS total scores less than or equal to 10 at the endpoint (at week 8). The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on 7-point scale, from 0 = not present/normal to 6 = severe/continuous presence of the symptoms and the total score (addition of all 10-items) ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression."|Day 7, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."|||Percentage of participants||95% Confidence Interval|Number
2629013|NCT01870843|Primary|Change in Sheehan Disability Scale (SDS) From Baseline up to Day 56|"SDS is a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in the participant's life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his or her (1) work, (2) social life or leisure activities, and (3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. To get a total score add up the 3 individual scores and the total score ranges from 0 = unimpaired to 30 = highly impaired. Higher scores indicate worsening."|Baseline, Day 14, Day 28, Day 42, and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."|||Units on a scale||Standard Deviation|Mean
2629014|NCT01870843|Primary|Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) From Baseline up to Day 56|"Q-LES-Q-SF is a 14-item questionnaire in which each question is rated on a 5-point scale with scores ranging from 1 = very poor to 5 = very good. The total raw score is calculated by summing up the scores for the 14 items. The raw total score ranges from 14 to 70. The raw total score is transformed into a percentage maximum possible score using the following formula: (raw total score minus minimum score) divided by (maximum possible raw score minus minimum score). The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Lower score indicate worsening."|Baseline, Day 14, Day 28, Day 42 and Day 56|"Full Analysis Set Population included who received at least 1 dose of the study drug, and completed at least 1 assessment visit during the treatment period. Here n (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome at given time point."|||Units on a scale||Standard Deviation|Mean
2629015|NCT01870778|Secondary|Change From Baseline in Cystatin C Biomarker|Blood samples were collected to assess the change from baseline in Cystatin C. The ratio of the post-baseline value to the baseline value is presented.|Baseline, Day 2, Day 5 and Day 14|Participants from the biomarker analysis set, who had both baseline and post baseline values for a given time point, were analyzed at that time point.|||mg/L||95% Confidence Interval|Least Squares Mean
2629016|NCT01870778|Secondary|Change From Baseline in NT-proBNP Biomarker|Blood samples were collected to assess the change from baseline in NT-proBNP. The ratio of the post-baseline value to the baseline value is presented.|Baseline, Day 2, Day 5 and Day 14|Participants from the biomarker analysis set, who had both baseline and post baseline values for a given time point, were analyzed at that time point.|||pg/mL||95% Confidence Interval|Geometric Least Squares Mean
2629017|NCT01870778|Secondary|Change From Baseline in hsTroponin T Biomarker|Blood samples were collected to assess the change from baseline in hsTroponin T. The geometric least square mean (LSM) of the ratio of the post-baseline value to the baseline value is presented.|Baseline, Day 2, Day 5 and Day 14|Participants from the biomarker analysis set, who had both baseline and post baseline values for a given time point, were analyzed at that time point.|||ug/L||95% Confidence Interval|Geometric Least Squares Mean
2629018|NCT01870778|Secondary|Percentage of Participants With First Improvement Since Baseline in Congestive Signs and Symptoms of Heart Failure|The percentage of participants with first improvement since baseline in congestive signs and symptoms was assessed. The signs and symptoms included exertional dyspnea, orthopnea, rales, jugular venous pressure and peripheral edema/pre-sacral edema.|From baseline to Day 5|The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was considered for the analysis. For each symptom, only participants with observed baseline signs and symptoms and non-missing baseline and post baseline signs and symptoms were analyzed.|||Percentage of participants|||Number
2629019|NCT01870778|Secondary|Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization|Length of stay was defined as the hospitalization discharge date and the time minus the baseline date and time plus 1 day.|180 days (Patients still in the hospital at Day 60 were censored at Day 60)|The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.|||days||Standard Deviation|Mean
2629020|NCT01870778|Secondary|Percentage of Participants With First Occurrence of Adjudicated CV Death or Adjudicated Re-hospitalization|The percentage of participants with adjudicated CV death or adjudicated re-hospitalization through day 180 was assessed.|180 days|The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.|||Percentage of participants|||Number
2629021|NCT01870778|Secondary|Length of Total Hospital Stay (LOS) During the Index Acute Heart Failure (AHF) Hospitalization|Length of stay was defined as the index hospitalization discharge date and time minus the baseline date and time plus 1 day.|180 days (Participants still in the hospital at Day 60 were censored at Day 60)|The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.|||days||Standard Deviation|Mean
2629022|NCT01870778|Secondary|Percentage of Participants With All-cause Death Through Day 180|The percentage of participants with all-cause death through day 180 was assessed.|180 days|The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.|||Percentage of participants|||Number
2629023|NCT01870778|Primary|Percentage of Participants With Worsening of Heart Failure (WHF) Through Day 5|The percentage of participants with WHF through day 5 was assessed.|Day 5|The Full Analysis Set, which included all randomized participants who were not mis-randomized or excluded due to GCP reasons, was analyzed.|||Percentage of participants|||Number
2629026|NCT01870739|Secondary|Change From Baseline in Carotid-femoral Pulse Wave Velocity at 52 Weeks|For pulse wave velocity calculation, the pressure waveform at the femoral site (using a partially inflated custom blood pressure cuff) and the carotid site (using hand -held applanation tonometry) were measured simultaneously. Pulse wave analysis was performed on the central aortic pressure waveform as derived from the brachial pressure waveform recorded in a partially-inflated blood pressure cuff around the upper arm.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis|||meters per second (m/s)||Standard Error|Least Squares Mean
2629027|NCT01870739|Secondary|Change From Baseline in Augmentation Index at 52 Weeks|Augmentation index (Alx) is the percentage of the central pulse pressure due to wave reflection.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis|||percent||Standard Error|Least Squares Mean
2629028|NCT01870739|Secondary|Change From Baseline in Augmentation Pressure at 52 Weeks|Augmentation pressure is the added pressure during systole due to wave reflection.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.|||mmHg||Standard Error|Least Squares Mean
2629029|NCT01870739|Secondary|Change From Baseline in Central Blood Pressure at 52 Weeks|Central blood pressure was determined by measuring central systolic blood pressure , diastolic blood pressure and pulse pressure.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.|||mmHg||Standard Error|Least Squares Mean
2629030|NCT01870739|Secondary|Change From Baseline in Regional Aortic Pulse Wave Velocity at 52 Weeks|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of regional aortic pulse wave velocity.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.|||meters per second (m/s)||Standard Error|Least Squares Mean
2629031|NCT01870739|Secondary|Change From Baseline in Local Aortic Strain at 52 Weeks|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic strain. Local aortic strain was measured by assessing ascending aorta strain, proximal descending aorta strain and distal descending aorta strain.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.|||percent||Standard Error|Least Squares Mean
2629032|NCT01870739|Primary|Change From Baseline in Distal Descending Aorta Distensibility at 52 Weeks|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Distal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.|||10^(-3) x mmHg^(-1)||Standard Error|Least Squares Mean
2629033|NCT01870739|Primary|Change From Baseline in Proximal Descending Aorta Distensibility at 52 Weeks|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Proximal descending aorta distensibility was one of the 3 components for measuring local arota distensibility.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.|||10^(-3) x mmHg^(-1)||Standard Error|Least Squares Mean
2629034|NCT01870739|Primary|Change From Baseline in Ascending Aorta Distensibility at 52 Week|Cardiovascular magnetic resonance imaging (MRI) scans were obtained at baseline prior to randomization, at week 52 for the assessment of local aortic distensibility. Ascending aorta distensibility was one of the 3 components for measuring local arota distensibility.|Baseline, 52 weeks|Pharmacodynamic (PD) analysis set: All patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data. Patients with both baseline and week 52 data were included in this analysis.|||10^(-3) x mmHg^(-1)||Standard Error|Least Squares Mean
2629035|NCT01870726|Secondary|Overall Survival (OS)|"Survival rate of patients from start of treatment to date of death due to any cause.~Patients did not reach the milestone for the survival data analysis (terminated early); as such no analysis was done."|throughout the duration of the trial - approximately 3 years (FPFV to LPLV)|Based on the phase I, a RP2D was not determined for the combination arm (Phase II combination arms were not opened). Patients did not reach the milestone needed for the OS analysis (at minimum the Bayesian model requires 30 patients) due to early termination, as such no analysis for OS was done.||||||
2629036|NCT01870726|Secondary|Best Overall Response (BOR)|"Best Overall Response (BOR) observed in the study population of INC280 Single Agent and in Combination with Buparlisib. Responses will be assessed by the investigators following the RANO criteria with MRI or CT scans scheduled every 8 weeks.~Summary of the RANO response criteria: CR has no T1-Gd+ (enhancing lesion), stable or decrease T2/FLAIR (non-enhancing lesion), absence of new lesion, stable or improve in clinical status; PR has ≥50% decrease T1-Gd+ (enhancing lesion), stable or decrease T2/FLAIR (non-enhancing lesion), absence of new lesion, stable or improve in clinical status; SD has ≥50% decrease but <25% increase T1-Gd+ (enhancing lesion), stable or decrease T2/FLAIR (non-enhancing lesion), absence of new lesion, stable or improve in clinical status; PD has ≥25% increase in T1-Gd+ (enhancing lesion), increase T2/FLAIR (non-enhancing lesion), presence of new lesion, deterioration in clinical status."|throughout the duration of the trial - approximately 3 years (from FPFV to LPLV)|FAS|||Participants|||Number
2629038|NCT01870726|Secondary|Pharmacokinetic Profile of Buparlisib - Tmax|Plasma concentration profile of INC280 in combination with Buparlisib. Tmax is the time to reach maximum (peak) observed concentration (Cmax) after dose administration|Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months|Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile.|||hr||Full Range|Median
2629039|NCT01870726|Secondary|Pharmacokinetic Profile of Buparlisib - Cmax|Plasma concentration profile of INC280 in combination with Buparlisib. Cmax is the Maximum (peak) observed drug concentration after dose administration.|Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months|Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile.|||ng/ml||Full Range|Median
2629040|NCT01870726|Secondary|Pharmacokinetic Profile of Buparlisib - AUCtau|Plasma concentration profile of Buparlisib in combination with INC280. AUCtau is the AUC from time zero to the end of dosing interval.|Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months|Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile.|||hr*ng/ml||Full Range|Median
2629041|NCT01870726|Secondary|Pharmacokinetic Profile of INC280 - T1/2|Plasma concentration profile of INC280 in combination with Buparlisib. T1/2 is the terminal half life|Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months|Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile.|||hr||Full Range|Median
2629042|NCT01870726|Secondary|Pharmacokinetic Profile of INC280 - Tmax|Plasma concentration profile of INC280 in combination with Buparlisib. Tmax is the time to reach maximum (peak) observed concentration (Cmax) after dose administration|Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months|Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile.|||hr||Full Range|Median
2629043|NCT01870726|Secondary|Pharmacokinetic Profile of INC280 - Cmax|Plasma concentration profile of INC280 in combination with Buparlisib. Cmax is the Maximum (peak) observed drug concentration after dose administration.|Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months|Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile.|||ng/ml||Full Range|Median
2629044|NCT01870726|Secondary|Pharmacokinetic Profile of INC280 - AUCtau|Plasma concentration profile of INC280 in combination with Buparlisib. AUCtau is the AUC from time zero to the end of dosing interval.|Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months|Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile.|||hr*ng/ml||Full Range|Median
2629045|NCT01870726|Secondary|Number of Participants With Adverse Events|"To characterize the safety of INC280 single agent and in combination with buparlisib including type, frequency, severity of adverse events, serious adverse events, and dose interruptions and adjustments. Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, unless otherwise specified.~If CTCAE grading did not exist for an AE, the severity of mild, moderate, severe, and lifethreatening, corresponding to Grades 1 - 4, were used. CTCAE Grade 5 (death) was not used in this study but was collected as a seriousness criterion; rather, information about deaths was collected though a Death form."|throughout the duration of the trial, approximately 3 years from FPFV to LPLV|Safety Analysis Set (SAS): The SAS comprised all patients who received at least one full or partial dose of study treatment. Patients were analyzed according to the treatment actually received. The SAS was used for all safety analyses.|||Participants|||Number
2629046|NCT01870726|Primary|Phase II Surgical Arm: Concentrations of INC280 and Buparlisib in Tumor.|Concentrations of INC280 and buparlisib in tumor tissue.|7 days|Based on the phase I, a RP2D was not determined for the combination and the phase II combination arms were not opened.||||||
2629047|NCT01870726|Primary|Phase II: Progression Free Survival Rate (PFSR)|"Estimated rate of patients treated during 6 months without experiencing disease progression.~The Progression Free Survival Rate at 6 months was to be estimated using a Bayesian model described in the protocol. The models operating characteristics were evaluated based on the enrollment of at least 30 patients enrolled. Patients did not reach the milestone for the PFSR analysis (trial terminated); as such no analysis was performed."|6 months|Based on the phase I, a RP2D was not determined for the combination arm (Phase II combination arms were not opened). Patients did not reach the milestone needed for the PFSR analysis (at minimum the Bayesian model requires 30 patients) due to early termination, as such no analysis for PFSR was performed.||||||
2629048|NCT01870726|Primary|Number of Patients Reporting Dose Limiting Toxicities (DLTs) in Cycle 1|A DLT is defined as an adverse event or abnormal laboratory value where the relationship to study treatment cannot be ruled out, and is not primarily related to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment (28 days) with INC280 in combination with buparlisib and meets any of the pre-defined criteria. The maximum tolerated dose was identified as INC280 300 mg BID + buparlisib 80 mg QD.|Cycle 1, 28 days|Dose determining set (DDS) consisted of all patients from the SAS who either met the minimum exposure criterion and had sufficient safety evaluations during Cycle 1, or discontinued earlier due to DLT during Cycle 1.|||Number of Patients|||Number
2629049|NCT01870596|Primary|Response Rate(CR/CRi) Rate|For descriptive purposes, the CR/CRi (complete response/Complete response with incomplete blood count recovery) rate will be reported at the end of the study separately for Arm A and Arm B. Responses are following definitions consistent with those published by Dohner H, Estey EH, Amadori S, et al. CR is defined as Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/μL and a platelet count of 100,000/μL, absence of blasts in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. CRi: All CR criteria except for residual neutropenia (ANC < 1000/μL)|Up to 3 years||||participants|||Number
2629050|NCT01870583|Primary|Cesarean Surgical Site Infection|Surgical site infection will follow CDC guidelines: A) Superficial incisional surgical site infection B) Deep incisional surgical site infection or C) Organ/space surgical site infection.|42 days after delivery||||Participants|||Count of Participants
2629051|NCT01870388|Primary|PK: Area Under the Concentration Versus Time Curve From Zero to Infinity [AUC(0-∞)] of Baricitinib||Predose up to 48 h postdose|Participants who received 1 dose of study drug and had evaluable PK data.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2629053|NCT01870297|Secondary|Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose|Least Squares Mean (LS) Mean change from baseline in fasting glucose was modeled using Mixed Effect Model Repeat Measurement (MMRM) analysis with fixed effects of baseline, treatment, day, treatment*day interaction, and participant as a random effect.|Baseline, Day 28|All randomized participants who received one dose of study drug and had evaluable PD data baseline and at least 1 post-baseline data in fasting glucose.|||milligram/deciliter (mg/dL)||Standard Error|Least Squares Mean
2629054|NCT01870297|Secondary|Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies||Predose on Day 7, 14, 28, 56, and 180|All randomized participants who received at least one dose of study drug in Part A and Part B.|||Participants|||Count of Participants
2629055|NCT01870297|Secondary|PK: Maximum Concentration (Cmax) of LY3025876||Days 1 and 28: Predose and 0.5 hr, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose|All randomized participants who received at least one dose of study drug and had evaluable Cmax PK data.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2629056|NCT01870297|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC[0-24]) of LY3025876|AUC(0-24) of individual participants was calculated by equation Area Under Concentration (AUC)=Dose/CL, where the clearance (CL) was estimated using a population PK model.|Predose and 0.5 hour(hr), 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose|All randomized participants who received at least one dose of study drug and had evaluable AUC 0-24 PK data.|||nanograms*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2629057|NCT01870297|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|Predose on Day 1 up to Day 56 in each Part|All randomized participants who received at least one dose of study drug.|||participants|||Number
2629058|NCT01870076|Secondary|Preoperative Cortisol Level|Cortisol level was compared among the 4 study groups.|Labs were drawn immediately pre-op.|Surgical patients who completed Polysomnography and pre-op study labs.|||mcg/dL||Standard Deviation|Mean
2629059|NCT01870076|Primary|Healing Touch Will Improve Total Sleep Time|Data from nocturnal polysomnography, specifically total number of minutes of sleep time, will be compared between the healing touch and non healing touch groups.|8 hours||||minutes||Standard Error|Mean
2629060|NCT01869959|Secondary|Change From Baseline to Day 28 in The Patient Health Questionnaire (PHQ-9) Score|Change from baseline to Day 28 in the PHQ-9 total score is presented. Participants were asked to score the severity of depressive symptoms over the last 2 weeks. Items were scored 0 (not at all), 1 (several days), 2 (half of the days), or 3 (nearly every day). The total PHQ-9 score is the sum of the score for each item and range from 0 to 27. A score of 0 means low depression severity and a score of 27 means high depression severity. Depression severity will be given a quality rating based on the total PHQ-9 score, as follows: None (0-4); Mild (5-9); Moderate (10-14); Moderately severe (15-19); and Severe (20-27). The PHQ-9 measurement obtained on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable PHQ-9 data.|||units on a scale||90% Confidence Interval|Least Squares Mean
2629061|NCT01869959|Secondary|Change From Baseline to Day 28 in the Food Preference Questionnaire (FPQ) Score|The table below represents the change from baseline in FPQ total score. The FPQ was administered to assess overall preference for foods of different macronutrient contents utilizing a macronutrient self-selection paradigm. Participants rated their preference on a range from 1 to 9 with 1 (dislike extremely) to 9 (like extremely) for a battery of 72 commonly consumed foods with fat content varying significantly in sugar, complex carbohydrates, and protein. The total score was calculated by averaging preference scores of 72 items. A low mean score of 1 to 9 scale indicate a low preference for the foods listed and a high mean score indicate a high preference for the foods listed. The FPQ measurement on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable FPQ data.|||units on a scale||90% Confidence Interval|Least Squares Mean
2629062|NCT01869959|Secondary|Change From Baseline to Day 28 in Eating Inventory for Cognitive Restraint of Eating, Disinhibition, and Hunger|Change from baseline to Day 28 in Eating Inventory (EI) subscales are presented. The EI is a 51-item inventory that measures dietary restraint (the cognitive intention to restrict energy intake; scores range from 0 to 21), disinhibition (the tendency to episodically overeat, often in response to external cues; scores range from 0 to 16), and perceived hunger (scores range from 0 to 14). A low score indicates a low exhibition of behavior and a high score indicates a high exhibition of behavior. The measurement for each variable obtained on Day -2 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment, day, and treatment times day as fixed effects, and baseline as covariate.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable EI data.|||units on a scale||90% Confidence Interval|Least Squares Mean
2629063|NCT01869959|Secondary|The Number of Participants With Anti-LY2405319 Antibodies|The number of participants that tested positive for anti-LY2405319 antibodies is presented.|Day 1 through Day 56|All participants who received at least 1 dose of study drug with evaluable anti-LY2405319 antibody data.|||number of participants|||Number
2629064|NCT01869959|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2405319|Cmax of LY2405319 is presented. Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 28.|Predose through Day 28 (48 hours postdose)|All participants who received at least 1 dose of study drug with evaluable Cmax of LY2405319 data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2629065|NCT01869959|Secondary|Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2405319|AUC for LY2405319 is presented. Data represent AUC for 1 dosing interval at steady state. Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, and 48 hours postdose on Day 28.|Predose through Day 28 (48 hours postdose)|All participants who received at least 1 dose of study drug with evaluable AUC of LY2405319 data.|||nanograms*hours/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2629066|NCT01869959|Secondary|Change From Baseline to Day 28 in C-Reactive Protein|Change from baseline to Day 28 in C-reactive protein is presented. The predose C-reactive protein measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as random effect.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable C-reactive protein data.|||milligrams per liter (mg/L)||90% Confidence Interval|Least Squares Mean
2629067|NCT01869959|Secondary|Change From Baseline to Day 28 in Adiponectin|Change from baseline to Day 28 in adiponectin is presented. The predose adiponectin measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, treatment times day as fixed effects, baseline as covariate, and participant as random effect.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable adiponectin data.|||nanograms per milliliter (ng/mL)||90% Confidence Interval|Least Squares Mean
2629068|NCT01869959|Secondary|Change From Baseline to Day 28 in Body Weight|Change from baseline to Day 28 in body weight is presented. The predose body weight measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, time, and treatment times time, treatment times day, and treatment times day times time were fixed effects; baseline as covariate; and participant as a random effect.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable body weight data.|||kilograms (kg)||90% Confidence Interval|Least Squares Mean
2629069|NCT01869959|Secondary|Change From Baseline to Day 28 in Fasting Lipid Profile|Change from baseline to Day 28 in fasting lipids, including cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and triglycerides is presented. The predose measurement for each variable on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as a random effect.|Baseline, Day 28|All participants who received at least 1 dose of study drug with evaluable fasting lipid (ie, cholesterol, LDL-C, HDL-C, and triglyceride) data.|||milligrams per deciliter (mg/dL)||90% Confidence Interval|Least Squares Mean
2629070|NCT01869959|Secondary|Change From Baseline to Week 4 in C-peptide Area Under the Curve (AUC)|Change from baseline to Week 4 in C-peptide AUC during an OGTT is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as a fixed effect and baseline as covariate.|Predose and 2 hours postdose (Baseline, Week 4)|All participants who received at least 1 dose of study drug with evaluable C-peptide AUC data.|||nanograms*hours/milliliter (ng*hr/mL)||90% Confidence Interval|Least Squares Mean
2629071|NCT01869959|Secondary|Change From Baseline to Week 4 in Insulin Area Under the Curve (AUC)|Change from baseline to Week 4 in insulin AUC during an OGTT is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as fixed effect and baseline as covariate.|Predose and 2 hours postdose (Baseline, Week 4)|All participants who received at least 1 dose of study drug with evaluable insulin (AUC) data.|||micro International units*hour/mL||90% Confidence Interval|Least Squares Mean
2629072|NCT01869959|Secondary|Change From Baseline to Week 4 in Glucose Area Under the Curve (AUC)|Change from baseline to Week 4 in glucose AUC during an oral glucose tolerance test (OGTT) is presented. Blood samples were obtained prior to the glucose bolus to 2 hours after administration of the glucose bolus. The AUC measurement on Day -1 served as the baseline value. LS means were calculated using an analysis of covariance model with treatment as fixed effect and baseline as covariate.|Predose and 2 hours postdose (Baseline, Week 4)|All participants who received at least 1 dose of study drug with evaluable glucose AUC data.|||milligrams*hr per deciliter (mg*hr/dL)||90% Confidence Interval|Least Squares Mean
2629073|NCT01869959|Secondary|7 Point Self-monitored Blood Glucose (SMBG)|The daily mean of the 7-point SMBG values is presented. Seven-point glucose profiles were measured by participants at baseline and at Week 4. The 7-point SMBG mean on Days -5, -4, or -3 served as the baseline value; the 7-point SMBG mean on Days 24, 25, or 26 served as the Week 4 value. Blood glucose was measured before and 2 hours after each meal and at bedtime.|Baseline (Day -5, -4, or -3) and Week 4 (Days 24, 25, or 26)|All participants who received at least 1 dose of study drug with evaluable 7-Point SMBG data.|||mg/dL||Standard Error|Mean
2629074|NCT01869959|Secondary|Change From Baseline to Day 28 in Fasting Glucose|Change from baseline to Day 28 in fasting blood glucose is presented. The predose fasting blood glucose measurement on Day 1 served as the baseline value. LS means were calculated using a linear mixed effects model with treatment, day, and treatment times day as fixed effects; baseline as covariate; and participant as a random effect.|Baseline, Day 28|Participants who received at least 1 dose of study drug with evaluable blood glucose data.|||milligrams per deciliter (mg/dL)||90% Confidence Interval|Least Squares Mean
2629075|NCT01869959|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 11.0. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Day 56|All participants who received at least 1 dose of study drug.|||number of participants|||Number
2629076|NCT01869777|Secondary|Overall Survival|Association between overall survival and standardized phase angle will be evaluated using a Cox proportional hazards model.|Up to 2 years||||Days||95% Confidence Interval|Median
2629077|NCT01869777|Secondary|Number of Participants With Receipt of Post-Remission Therapy|Logistic regression will be used to analyze the association between standardized phase angle and receipt of post-remission therapy.|Up to 2 years||||Participants|||Count of Participants
2629078|NCT01869777|Secondary|Number of Participants to Achieve Complete Remission|Logistic regression will be used to analyze the association between standardized phase angle and complete remission. Complete remission is defined as less than 5% marrow blasts, absolute neutrophil count > 1000, platelet count > 100,000 and freedom from red cell transfusions|Up to 2 years||||Participants|||Count of Participants
2629079|NCT01869777|Secondary|Number of Participants With Bone Marrow Response|Logistic regression will be used to analyze the significant association between standardized phase angle and marrow response at 14-day bone marrow biopsy to show the odds of having 14-day residual disease (presence cancer cells remaining after treatment) and non-residual disease (no cancer cells remaining after treatment). (14 day bone marrow response is defined as hypoplastic marrow with less than 20% cellularity and 5% blasts. Complete remission is defined as less than 5% marrow blasts, absolute neutrophil count >1000, platelet count >100,000 and freedom from red cell transfusions).|14 days|14 participants excluded in analysis due to 14-day bone marrow data not available.|||Participants|||Count of Participants
2629080|NCT01869777|Secondary|Number of Participants Transferred to Intensive Care Unit During Induction|Logistic regression will be used to analyze the association between standardized phase angle and transfer to intensive care unit.|Up to 2 years||||Participants|||Count of Participants
2629081|NCT01869777|Secondary|Length of Hospitalization|A linear model will be used to look at the association of standardized phase angle and length of hospital stay.|Up to 2 years||||Days||Standard Deviation|Mean
2629082|NCT01869777|Secondary|Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 30 Days After Registration|Logistic regression will be used to analyze the association between standardized phase angle and 30 day mortality. 30 day mortality rate is defined as the percent of patients no longer alive at 30 days after registration.|30 days||||Participants|||Count of Participants
2629083|NCT01869777|Primary|Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 60 Days After Registration|Logistic regression will be used to analyze the association between standardized phase angle and 60 day mortality. 60 day mortality rate is defined as the percent of patients no longer alive at 60 days after registration. Patients that are discharged to hospice care before 60 days without a known date of death will be counted towards 60 day mortality|60 days||||Participants|||Count of Participants
2629084|NCT01869764|Secondary|Number of Days to Establish Increased Apoptosis in Malignant Breast Tissue|ANOVA will be used to assess the effect of the supplementation in malignant breast tissue with greater apoptosis in malignant breast tissue in comparison to women who took the placebo.|At time of surgery||||Days on treatment||Standard Deviation|Mean
2629085|NCT01869764|Secondary|Number of Days to Establish Difference in Proliferation in Malignant Breast Tissue|ANOVA will be used to assess the effect of the supplementation in malignant breast tissue with less proliferation in malignant breast tissue in comparison to women who took the placebo.|At time of surgery||||Days on treatment||Standard Deviation|Mean
2629086|NCT01869764|Secondary|Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue|ANOVA will be used to assess the effect in normal and malignant breast tissue. Metabolites tested: PGE2, PGD2, 20-HETE, 5-HEPE, 13-HODE, 9-HODE, 15-HETE, 12-HETE, 5-HETE.|At time of surgery||||ug/ml||Standard Deviation|Mean
2629087|NCT01869764|Primary|PUFA Levels in Red Blood Cells Pre and Post Surgery|Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3|Pre and post surgery|All samples measurements were not available for all participants to be analyzed.|||ug/ml||Standard Deviation|Mean
2629088|NCT01869764|Primary|PUFA Levels in Plasma Pre and Post Surgery|Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3|Pre and post surgery|All samples measurements were not available for all participants to be analyzed.|||ug/ml||Standard Deviation|Mean
2629089|NCT01869764|Primary|PUFA Levels in Normal and Metastatic Breast Tissue|Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3|At time of surgery|All samples measurements were not available for all participants to be analyzed.|||ug/ml||Standard Deviation|Mean
2629090|NCT01869699|Secondary|2-hour Change Over Time Heart Rate|2-hour change over time heart rate from time of study drug administration (means adjusted to baseline HR)|Baseline to 2 hours||||BPM||Standard Error|Mean
2629091|NCT01869699|Secondary|2-hour Change Over Time Systolic Blood Pressure|2-hour change over time SBP from study drug administration (means adjusted to baseline SBP)|Baseline to 2 hours||||mm Hg||Standard Error|Mean
2629092|NCT01869699|Secondary|2-hour Change Over Time Core Temperature|change over time core temperature after study drug administration (adjusted to baseline core temperature)|2 hours||||degrees Celsius||Standard Error|Mean
2629093|NCT01869699|Secondary|Respiratory Rate|time weighted average for respiratory rate over 4 hours. Respiratory rate was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the respiratory rate values was divided by time in minutes.|Baseline to 4 hours post study drug administration|Patients in the ICU with fever, weight of > 50kg and no exclusion criteria met.|||breaths per minute||Standard Error|Mean
2629094|NCT01869699|Secondary|Systolic Blood Pressure|time-weighted average systolic blood pressure over 4 hours. Systolic blood pressure was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the systolic blood pressure values was divided by time in minutes.|Baseline to 4 hours post study drug administration||||mm Hg||Standard Error|Mean
2629095|NCT01869699|Secondary|Heart Rate|time-weighted average heart rate over 4 hours. Heart rate was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the heart rate values was divided by time in minutes.|Baseline to 4 hours post study drug administration|Patients in the ICU with fever, weight of > 50kg and no exclusion criteria met.|||beats per minute||Standard Error|Mean
2654577|NCT01634269|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA)||6 months||||cm²||Standard Deviation|Mean
2629096|NCT01869699|Primary|Core Body Temperature|time-weighted average core body temperature over 4 hours. Core temperature was measured every 5 minutes times 4, and then every 15 minutes over the following 4 hours from the time of study drug administration. The sum of the core temperature values was divided by time in minutes.|Baseline to 4 hours post study drug administration|Patients in an ICU with fever, weighed > 50kg and did not meet any exclusion criteria.|||degrees Celsius||Standard Error|Mean
2629097|NCT01869686|Secondary|Ratio of Denosumab Seminal Fluid Concentration Over the Denosumab Serum Concentration at the Last Study Time Point (Day 106).||Day 106|Pharmacokinetic population with available data|||ratio||Standard Deviation|Mean
2629098|NCT01869686|Secondary|Ratio of Seminal Fluid AUC by Serum AUC for the 106 Day Dosing Period|The ratio of denosumab seminal fluid AUC over denosumab serum AUC for the 106-day dosing period.|Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population|||ratio||Standard Deviation|Mean
2629099|NCT01869686|Secondary|Ratio of Maximum Seminal Fluid Concentration by the Serum Concentration (Cmax Ratio)|The ratio of maximum denosumab seminal fluid concentration over the denosumab serum concentration at the corresponding time point (Cmax Ratio)|Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population with available data|||ratio||Standard Deviation|Mean
2629100|NCT01869686|Secondary|Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Denosumab in Serum|The area under the denosumab serum concentration-time curve from time zero to last quantifiable concentration (AUClast), estimated using the linear trapezoidal method.|Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population|||days*ng/mL||Standard Deviation|Mean
2629101|NCT01869686|Secondary|Time to Maximum Observed Concentration (Tmax) of Denosumab in Serum||Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population|||days||Full Range|Median
2629102|NCT01869686|Secondary|Maximum Observed Concentration (Cmax) of Denosumab in Serum||Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population|||ng/mL||Standard Deviation|Mean
2629103|NCT01869686|Primary|Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Denosumab in Seminal Fluid|The area under the denosumab seminal fluid concentration-time curve from time zero to last quantifiable concentration (AUClast), estimated using the linear trapezoidal method.|Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population|||days*ng/mL||Standard Deviation|Mean
2629104|NCT01869686|Primary|Time to Maximum Observed Concentration (Tmax) of Denosumab in Seminal Fluid||Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population with available data|||days||Full Range|Median
2629105|NCT01869686|Primary|Maximum Observed Concentration (Cmax) of Denosumab in Seminal Fluid||Days 1, 10, 22, 36, 50, 78 and 106|Pharmacokinetic population|||ng/mL||Standard Deviation|Mean
2629106|NCT01869647|Secondary|Prevalence of Urological Intervention|This measure presents the prevalence of participants needing urological intervention in each arm within 90 days.|90 days||||participants|||Number
2629107|NCT01869647|Primary|Radiation Exposure (Dose-Length-Product) at Baseline|Radiation exposure at baseline was collected using the mean dose length product mGy*cm.|Baseline (at enrollment)||||mGy*cm||95% Confidence Interval|Mean
2629108|NCT01869634|Other Pre-specified|Change in Systemic Immune Activation|Change in systemic immune activation, as measured by change in plasma cytokine levels (IL-6).|Baseline, 12 months||||pg/ml||Inter-Quartile Range|Median
2629109|NCT01869634|Secondary|Change in Percentage of Total Artery Diameter|computerized axial tomography angiography of the coronary arteries (CT-angio) before and after 12-months of Darunavir therapy|Baseline, 12 months|We compare wall thickness between HIV+ infected individuals and in the HIV group before and after 12-months of ART.|||% of total artery diameter||Inter-Quartile Range|Median
2629110|NCT01869634|Primary|Number of CD4+ T-cells in the Lamina Propria/mm2 Before and After 12 Months of Therapy Compared to Age-matched Control Volunteers Without HIV|CD4+ T-cells in the lamina propria/mm2 before and after 12 months of therapy compared to age-matched control volunteers without HIV.|Baseline, 12 months|HIV negative participants underwent the procedures only once at Screening (entry). In the HIV group the comparison between before and after ART was done using a Wilcoxon signed-rank test.|||cells / mm^2||Inter-Quartile Range|Median
2629111|NCT01869478|Secondary|Mean Score on Modified Rankin Scale at 90 Days|Functional outcome at 90-days will be assessed with the modified Rankin Scale (mRS). The Modified Rankin Scale was completed by the physician; it is a 7 point scale rating any limitations in the study subject's social role. The scale ranges from 0 (no symptoms/disability) to 6 (death).|90 days|Only one participant was enrolled, so data analysis was not possible.||||||
2629112|NCT01869478|Primary|Recanalization Rate of Primary Intracranial Occlusion|The degree of recanalization (none, partial, complete) will be assessed in a blinded fashion on the 24-hour computed tomographic angiogram (CTA).|24 hours|Only one participant was enrolled, so data analysis was not possible.||||||
2629113|NCT01869439|Primary|Within and Between Reader Agreement for the Measurement Techniques: Scout Length by Width, Scout Trace Area, and Scout Trace Perimeter|Establish within and between reader agreement of the Scout Length by Width, Scout trace area, and Scout trace perimeter.|90 Days|40 wounds captured in an inpatient and outpatient population.|||percentage of CV||Geometric Coefficient of Variation|Geometric Mean
2629114|NCT01869348|Other Pre-specified|Acceptability|Acceptability will be self-reported using a variety of items taken from previous studies of physical activity interventions and usability|12 weeks|||||||
2629115|NCT01869348|Other Pre-specified|Feasibility|We will use many different measures of feasibility, including adherence to study protocol, attrition, barriers to adherence, exposure/dose of intervention received, and any adverse events that occur|12 weeks|||||||
2629116|NCT01869348|Secondary|Change in Weight From Baseline to 12 Weeks|We will measure weight (and height at baseline) using a calibrated scale|12 weeks|||||||
2629117|NCT01869348|Secondary|Change in Physical Function From Baseline to 12 Weeks|Functional measurements will be made using the Senior Fitness Test|12 weeks|||||||
2629118|NCT01869348|Secondary|Change in Body Composition From Baseline to 12 Weeks|We will use dual x-ray absorptiometry (DEXA) to measure body composition, including body fat percentage and lean mass|12 weeks|||||||
2629119|NCT01869348|Secondary|Change in Physical Fitness From Baseline to 12 Weeks|We will use the six minute walk test to measure physical fitness|12 weeks|||||||
2629120|NCT01869348|Secondary|Change in Autonomous Motivation From Baseline to 12 Weeks|We will measure feelings of autonomous and controlled motivation/regulation for physical activity|12 weeks|||||||
2629124|NCT01869192|Primary|Overall Response Rate|To describe the overall response rate as measured by physical exam and MRI if indicated using the following definition: Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 8 months||||Participants|||Count of Participants
2629125|NCT01869075|Primary|Percentage of Patients Prescribed Appropriate VTE Prophylaxis|"Rates of appropriate VTE prophylaxis were determined as the number of patients who received VTE prophylaxis as a proportion of the number of patient at risk.~Rates reported are for the active phases (phase 1 and phase 2) and compare intervention to control.~Appropriate VTE prophylaxis was defined as:~in Hip Fracture Surgery - evidence-based VTE prophylaxis ordered within 24 of admission, restarted within 24 hours after surgery and continued for at least 10 days post-discharge in Major General Surgery - evidence-based VTE prophylaxis ordered within 24 hours post-surgery and continued for the duration of hospital stay in Acute Medical Illness - evidence-based VTE prophylaxis ordered within 24 hours of admission and continued for the duration of hospital stay.~Evidence-based VTE prophylaxis was determined to be according to the American College of Chest Physicians (ACCP) guidelines. The 9th version was the most current version at the time of the study."|End of study (end of phase 2) - measured over duration of hospital stay.|The number of participants in the analysis was 720. In phase 1, there were 360 patients included and in phase 2, an additional 360 patients were included. The outcomes by end of study (end of phase 2) are reported. The patients in control (usual care) and intervention (Knowledge Translation toolkit) were compared.|||percentage of patients|||Number
2629126|NCT01868997|Secondary|Overall Average Change From Baseline in GO-QOL Scale - Appearance to Week 24 (MMRM)|The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of TED by the participants on their daily physical and psychosocial functioning. Two subscales of the 16-question GO-QOL have been defined: Visual Functioning and Appearance, with 8 questions comprising each subscale. Transformed Appearance score is the sum of scores from the following 8 questions to a scale of 0 (worst health) to 100 (best health): feel appearance has changed, feel being stared at, feel people react unpleasantly, influence on self-confidence, feel socially isolated, influence on making friends, appear less often on photos, try to mask changes in appearance.|Baseline to Week 24|Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2629127|NCT01868997|Secondary|Overall Average Change From Baseline in GO-QOL Scale - Visual Functioning to Week 24 (MMRM)|The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of TED by the participants on their daily physical and psychosocial functioning. Two subscales of the 16-question GO-QOL have been defined: Visual Functioning and Appearance, with 8 questions comprising each subscale. Transformed Visual Functioning score is the sum of scores from following 8 questions to a scale of 0 (worst health) to 100 (best health): bicycling, driving, moving around the house, walking outdoors, reading, watching television (TV), hobby or pastime, feel hindered.|Baseline to Week 24|Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2629128|NCT01868997|Secondary|Overall Average Change From Baseline in CAS to Week 24 (MMRM)|The 7-item European Group on Graves' Ophthalmopathy (EUGOGO) amended CAS was used to evaluate clinical activity. For each of the following items, one point is given: spontaneous orbital pain, gaze evoked orbital pain, eyelid swelling that is considered to be due to active (inflammatory phase) Graves' ophthalmopathy (GO), eyelid erythema, conjunctival redness that is considered to be due to active (inflammatory phase) GO, chemosis, and inflammation of caruncle or plica. The sum of these points is the total score, with 0 indicating no clinical activity and 7 indicating the most severe clinical activity.|Baseline to Week 24|Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2629129|NCT01868997|Secondary|Overall Average Change From Baseline in Proptosis of the Study Eye to Week 24 (MMRM)|Proptosis is the amount of protrusion of the eye from the orbital rim. Measurements were recorded using the Hertel exophthalmometer. Participants with a decrease ≥ 2 mm were considered improving, those with an increase or decrease < 2 mm were considered remaining stable, and those with an increase ≥ 2 mm were considered worsening.|Baseline to Week 24|Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment.|||mm||Standard Error|Least Squares Mean
2629130|NCT01868997|Secondary|Overall Average Change From Baseline in Graves' Ophthalmopathy Quality of Life (GO-QOL) Scale - Overall to Week 24 (Mixed-Model Repeated Measures [MMRM])|The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of thyroid eye disorder (TED) by the participants on their daily physical and psychosocial functioning. Two subscales of the 16-question GO-QOL have been defined: Visual Functioning and Appearance, with 8 questions comprising each subscale. The transformed overall score is the sum of scores from all 16 questions to a scale of 0 (worst health) to 100 (best health).|Baseline to Week 24|Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo). A change from baseline of zero was imputed at the first postbaseline visit for participants with no postbaseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2629131|NCT01868997|Primary|Responder Status at Week 24|Number of participants classified as responders and non-responders at Week 24. Responders were defined as participants with a reduction in clinical activity score (CAS, see Outcome Measure 4 description for details) of ≥ 2 points, and a reduction in proptosis (amount of protrusion of the eye from the orbital rim) of ≥ 2 mm in the study eye, and no deterioration (increase in CAS of ≥ 2 points or increase in proptosis of ≥ 2 mm) in the non-study eye. Participants who had no assessment at 24 weeks were considered non-responders.|Week 24|Intent to Treat Population: all participants who were randomized to treatment and received at least 1 dose of medication (either teprotumumab or placebo).|||Participants|||Count of Participants
2629132|NCT01868893|Secondary|Number of Participants With Objective Response|Objective response is defined as either complete response [CR], complete response with incomplete recovery [CRi], or partial response [PR] as determined by the treating physician's standard practice at the end of treatment or premature discontinuation from study per the International Workshop on Chronic Lymphocytic Leukemia Criteria (iwCLL criteria). Patients who have not achieved a CR or a PR, and who have not exhibited progressive disease, will be considered to have stable disease (which is equivalent to a nonresponse).|Up to end of treatment or premature discontinuation from study (up to 7 months from Day 1)|Efficacy evaluable population: It included participants who received at least one dose of study drug and had measurable disease at baseline and at least one post-baseline tumor assessment or who died within 28 days after the last dose of the study drug|||participants|||Number
2629133|NCT01868893|Secondary|Number of Participants With Adverse Events (AEs), AEs of Grade 3 and Above Severity, AEs of Special Interest (AESI), AEs Leading to Obinutuzumab Discontinuation or Dose Delays, Serious Adverse Events (SAEs), and Death|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 was used for grading the AEs. According to NCI CTCAE, Grade 3 = severe or medically significant but not immediately life threatening; Grade 4 = life-threatening consequences, urgent intervention indicated, and Grade 5 = death. AESIs included all tumor lysis syndrome, serious infections, serious infusion-related reactions (IRR), and hepatitis B reactivation. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 28 days after the last dose of study drug (up to 7 months from Day 1)|Safety Population: It included all enrolled participants who received at least one dose of study drug.|||participants|||Number
2629134|NCT01868893|Primary|Number of Participants Who Received Obinutuzumab and Chlorambucil in the Study|Number of participants who received obinutuzumab and chlorambucil in the study are presented in the below table.|Cycles 1 to 6 (28-day cycles)|Intent-to-Treat population: It included all enrolled participants in the study.|||participants|||Number
2629135|NCT01868789|Primary|Change in Navicular Rotation Between Touch-down Bearing and Full-weight Bearing|Relative motion across joint segments will be determined by comparing the joint orientation across two time points: touch-down bearing (TDWB, 25-50% body weight) and full-weight bearing (FWB, greater that 75-100% body weight) as measured on CT.|1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing||||degrees||Standard Deviation|Mean
2629136|NCT01868789|Primary|Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular|Relative motion, which is the position of the full weightbearing (FWB, greater that 75-100% body weight) navicular in comparison to the touch down weightbearing (TDWB, 25-50% body weight) navicular position, will be determined by comparing the joint orientation across these two points on one CT scan. The difference between the two positions is reported below.|1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing||||mm||Standard Deviation|Mean
2629137|NCT01868776|Primary|Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis.|100 patients diagnosed with symptomatic irreversible pulpitis of a mandibular posterior tooth randomly received a conventional inferior alveolar nerve block (IAN) block using either 2.8 ml of 4% lidocaine with 1:100,000 epinephrine or 2.8 ml of 4% lidocaine with 1:100,000 epinephrine buffered with sodium bicarbonate in a double-blind manner. For the buffered solution, each cartridge was buffered with 8.4% sodium bicarbonate to produce a final concentration of 0.18 mEq/mL of sodium bicarbonate. Fifteen minutes after administration of the IAN block, profound lip numbness was confirmed and endodontic access was initiated. Success was determined as no or mild pain on access or instrumentation of the root canal. Higher numbers on the VAS are indicative of more pain and less success and the VAS scale ranged from 0 to 170 mm.|approximately 15 minutes after injection||||percentage of participants|||Number
2629138|NCT01868776|Primary|Pain Measurement as Assessed on a Visual Analog Scale||pain at time of treatment (after buffered versus nonbuffered numbing solution) average of 15 minutes after injection||2015-12-31|12/2015||||
2629139|NCT01868646|Secondary|Satisfaction of Diabetes Treatment Based on Diabetes Treatment Satisfaction Questionnaire Data|"The Diabetes Treatment Satisfaction Questionnaire allows to assess the degree of satisfaction with treatment for diabetes and its complications - retinopathy and nephropathy, how patients' satisfaction and perceived hyper- and hypoglycemia have changed compared to the initial period (before the treatment).~The Diabetes Treatment Satisfaction Questionnaire contains six items scored on 7-point scales from +3 (equals very satisfied) to -3 (equals very dissatisfied), with 0 (equals no change). These are summed to produce a total Treatment Satisfaction score. Two questions concerning Perceived Hyperglycaemia and Perceived Hypoglycaemia respectively, are calculated separately. According to these two items, low scores represent good perceived blood glucose control (+3 means most of the time of Hyperglycaemia or Hypoglycaemia whereas -3 means none of the time of Hyperglycaemia or Hypoglycaemia)."|In 36 weeks of the treatment|Intention-to-Treat set. 8 patients (6 in the Subetta group and 2 in the Placebo group) was excluded from the analysis due to lake of questionnaires.|||Scores on a scale||Standard Deviation|Mean
2629140|NCT01868646|Secondary|Changes in the Mean Absolute Value of Body Mass Index (BMI) (kg/m^2)||baseline and 36 weeks of the treatment|Intention-to-Treat set. Data on body weight in one patient from the placebo group were absent|||kg/m^2||Standard Deviation|Mean
2629141|NCT01868646|Secondary|Changes in the Mean Absolute Value of Body Weight (kg)||In 36 weeks of the treatment as compared to the baseline|Intention-to-Treat set. Data on body weight in one patient from the placebo group were absent|||kg||Standard Deviation|Mean
2629142|NCT01868646|Secondary|Percentage of Patients With Changed Daily Dose of Per Oral Blood Sugar- Lowering Drugs||In 36 weeks of the treatment|Intention-to-Treat set|||percentage of patients|||Number
2629169|NCT01868503|Secondary|Pathologic Complete Response Rate for Those Patients Undergoing Surgical Resection Defined as no Evidence of Residual Tumor in the Breast and Lymph Nodes|Proportion of patients who achieve a pathological complete response will be estimated with 95% exact confidence intervals.|Up to 12 weeks|Of the patients in the treatment arm, only 1 received surgery.|||Participants|||Count of Participants
2629143|NCT01868646|Secondary|Changes in Dosage of Insulin (Basal Dose Insulin Measured in IU/ kg of Body Weight)|"Changes in basal insulin dose is based on the mean value of 3 consecutive measuring of level of fasting blood glucose.~If value of fasting blood glucose at 7:00 AM on January 21, 2012 - 4.2 mmol/L, at 7:30 AM on January 22, 2012- 5.0 mmol/L, at 7:00 AM on January 23, 2012 4.8 mmol/L, then the mean level of blood glucose =4.7 mmol/L (4.2 +5.0 +4.8 divided by 3). It is not recommended to change the dose.~If the mean value of fasting blood glucose is lower than 4.0 mmol/L and a patient shows unreasonable signs or symptoms of hypoglycemia, then dose of basal insulin should be reduced by 2 units.~If value of fasting blood glucose for 3 consecutive days was ≥7 mmol/L, then dose of basal insulin should be increased by 2 units and more (depending on individual values).~Based on the same values investigator can change dose of per oral blood sugar-lowering drugs."|In 36 weeks of the treatment as compared to the baseline|Intention-to-Treat set|||IU/kg||Standard Deviation|Mean
2629144|NCT01868646|Secondary|Changes in Dosage of Insulin (Basal Dose Insulin Measured in IU/Day)|"Changes in basal insulin dose is based on the mean value of 3 consecutive measuring of level of fasting blood glucose.~If value of fasting blood glucose at 7:00 AM on January 21, 2012 - 4.2 mmol/L, at 7:30 AM on January 22, 2012- 5.0 mmol/L, at 7:00 AM on January 23, 2012 4.8 mmol/L, then the mean level of blood glucose =4.7 mmol/L (4.2 +5.0 +4.8 divided by 3). It is not recommended to change the dose.~If the mean value of fasting blood glucose is lower than 4.0 mmol/L and a patient shows unreasonable signs or symptoms of hypoglycemia, then dose of basal insulin should be reduced by 2 units.~If value of fasting blood glucose for 3 consecutive days was ≥7 mmol/L, then dose of basal insulin should be increased by 2 units and more (depending on individual values).~Based on the same values investigator can change dose of per oral blood sugar-lowering drugs."|In 36 weeks of the treatment as compared to the baseline|Intention-to-Treat|||IU/day||Standard Deviation|Mean
2629145|NCT01868646|Secondary|Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides)|Blood samples (for measurement of fasting plasma glucose, concentrations of plasma total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) are taken under standard conditions: after night break in food taking (at least 12 hours) and prior to administering of insulin morning dose (prandial), prior to any morning medicines intake (including the study drug and permitted concomitant therapy).|In 12, 24 and 36 weeks of the treatment as compared to the baseline|Intention-to-Treat set.|||mmol / l||Standard Deviation|Mean
2629146|NCT01868646|Secondary|Mean Value of C-peptide|Blood samples (for measurement of fasting plasma glucose, concentrations of plasma C-peptide, total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) are taken under standard conditions: after night break in food taking (at least 8 hours) and prior to administering of insulin morning dose (if patient receives intermediate insulin twice-daily), prior to any morning medicines intake (including the study drug, metformin, sulfonylurea derivatives, permitted concomitant therapy).|In 12, 24 and 36 weeks of the treatment as compared to the baseline|Intention-to-Treat set.|||pmol / l||Standard Deviation|Mean
2629147|NCT01868646|Secondary|Change in Average Daily Blood Glucose From a 7-point Patient Self-monitoring of Blood Glucose (SMBG)|A 7-point patient self-monitoring of blood glucose (SMBG): three measurements of blood glucose before the meal; three measurements of postprandial blood glucose (1-2 h after the start of the meal) and one measurement at 3:00 a.m.|During the whole study period (on weeks 4, 8, 12, 18, 24, 30 and 36 of the treatment) as compared to the baseline|Intention-to-Treat set. The SMBG in 3 patients (2 in the Subetta and 1 in the Placebo) was excluded from the analysis due to mistakes in diaries.|||mmol / l||Standard Deviation|Mean
2629148|NCT01868646|Secondary|Change in Fasting Plasma Glucose|Based on the data of biochemical analysis|In 4, 12, 24 and 36 weeks of the treatment as compared to the baseline|Intention-to-Threat set|||mmol / l||Standard Deviation|Mean
2629149|NCT01868646|Primary|Changes in the Mean Value of HbA1c|The HbA1C test was performed using a method that is certified by the National Glycohemoglobin Standardization Program (NGSP) (www.ngsp.org) and standardized or traceable to the Diabetes Control and Complications Trial (DCCT) reference assay.|In 12, 24 and 36 weeks of the treatment as compared to the baseline|Intention-to-Treat set|||percentage of HbA1c||Standard Deviation|Mean
2629150|NCT01868633|Other Pre-specified|Number of Participants With Chronic Pain After Cesarean Delivery|Comparison of incidence of chronic pain associated with cesarean delivery between the 2 groups|6 months|Study participants had a telephone call follow-up 6 months after cesarean delivery by a research nurse. They were asked questions about current pain symptoms and if it is related to their cesarean delivery. Seven patients in the dexamethasone group and eight patients in the placebo did not respond when contacted|||Participants|||Count of Participants
2629151|NCT01868633|Secondary|Incidence and Severity of Nausea and Pruritus|Patients were asked to rate the severity of postoperative nausea using an 11-point numerical rating scale (NRS) from 0 to 10, (0: no nausea, 10: worst nausea possible). The number of vomiting episodes, if any during the 24-hour study period, was documented. Pruritus was also assessed using an 11-point NRS (0 no pruritus,10 worst pruritus possible)|24 hours||||units on a scale||Inter-Quartile Range|Median
2629152|NCT01868633|Secondary|Quality of Recovery|Comparison of the quality of Recovery between the 2 groups using a Quality of recovery questionnaire (QoR-40). It incorporates five dimensions of health: patient support, comfort, emotions, physical independence, and pain; each item is graded on a five-point Likert scale. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). The scores on all 40 items are summed and the mean scores and standard deviation calculated for each study group|48 hours|Two patients in the dexamethasone group and 8 patients in the placebo did not complete the quality of recovery questionnaire.|||units on a scale||Standard Deviation|Mean
2629153|NCT01868633|Secondary|Postoperative Pain at Rest and With Movement 24 Hours After Cesarean Delivery|"Pain scores were assessed at 6, 12 and 24 hours after surgery using a numerical rating scale (10 cm line marked at 1 cm intervals anchored on the left with no pain = 0 and the worst possible pain = 10). Pain was assessed at rest and with movement"|24 hours||||units on a scale||Inter-Quartile Range|Median
2629154|NCT01868633|Primary|Postoperative Analgesia|Comparison of postoperative opioid analgesia use between the 2 groups|24 hours||||milligrams of morphine||Inter-Quartile Range|Median
2629170|NCT01868503|Secondary|Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Adverse events will be tabulated by organ system and severity.|Up to 12 weeks|Participants enrolled in the study.|||incidencts|||Number
2629155|NCT01868594|Secondary|Satisfaction of Diabetes Treatment Based on Diabetes Treatment Satisfaction Questionnaire Data|"The Diabetes Treatment Satisfaction Questionnaire allows to assess the degree of satisfaction with treatment for diabetes and its complications - retinopathy and nephropathy, how patients' satisfaction and perceived hyper- and hypoglycemia have changed compared to the initial period (before the treatment).~The Diabetes Treatment Satisfaction Questionnaire contains six items scored on 7-point scales from +3 (equals very satisfied) to -3 (equals very dissatisfied), with 0 (equals no change). These are summed to produce a total Treatment Satisfaction score. Two questions concerning Perceived Hyperglycaemia and Perceived Hypoglycaemia respectively, are calculated separately. According to these two items, low scores represent good perceived blood glucose control (+3 means most of the time of Hyperglycaemia or Hypoglycaemia whereas -3 means none of the time of Hyperglycaemia or Hypoglycaemia)."|36 weeks of the treatment|Intention-to-Treat set. 6 patients (1 in the Subetta group and 5 in the Placebo group) was excluded from the analysis due to lake of questionnaires.|||score on a scale||Standard Deviation|Mean
2629156|NCT01868594|Secondary|Changes in Dosage of Total Insulin Measured in IU/kg of Body Weight|Insulin dose should be corrected by a patient on a daily basis taking into consideration data on blood glucose self- monitoring during a day and amount of food carbohydrates. Physician can correct insulin dose based on the same data.|baseline and 36 weeks of the treatment|Intention-to-Treat set|||IU/kg||Standard Deviation|Mean
2629157|NCT01868594|Secondary|Changes in Dosage of Insulin (Basal, Prandial and Total Daily Dose Insulin Measured in IU)|Insulin dose should be corrected by a patient on a daily basis taking into consideration data on blood glucose self- monitoring during a day and amount of food carbohydrates. Physician can correct insulin dose based on the same data.|baseline and 36 weeks of the treatment|Intention-to-Treat set|||IU||Standard Deviation|Mean
2629158|NCT01868594|Secondary|Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides)|Blood samples (for measurement of fasting plasma glucose, concentrations of plasma total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) are taken under standard conditions: after night break in food taking (at least 12 hours) and prior to administering of insulin morning dose (prandial), prior to any morning medicines intake (including the study drug and permitted concomitant therapy).|baseline and 12, 24 and 36 weeks of the treatment|Intention-to-Treat set|||mmol / l||Standard Deviation|Mean
2629159|NCT01868594|Secondary|Change in Average Daily Blood Glucose From a 7-point Patient Self-monitoring of Blood Glucose (SMBG)|"A 7-point patient self-monitoring of blood glucose (SMBG):~three measurements of blood glucose before the meal; three measurements of postprandial blood glucose (1-2 h after the start of the meal) and one measurement at 3:00 a.m."|baseline and 4, 8, 12, 18, 24, 30 and 36 weeks of the treatment|Intention-to-Treat. 2 patients (1 in Subetta group and 1 in Placebo group) was excluded from the analysis due to lake of diaries|||mmol / l||Standard Deviation|Mean
2629160|NCT01868594|Secondary|Change in Fasting Plasma Glucose (Based on the Data of Biochemical Analysis)||baseline and 4, 12, 24 and 36 weeks of the treatment|Intention-to-Treat set|||mmol / l||Standard Deviation|Mean
2629161|NCT01868594|Primary|Changes in the Mean Value of HbA1c|The HbA1C test was performed using a method that is certified by the National Glycohemoglobin Standardization Program (NGSP) (www.ngsp.org) and standardized or traceable to the Diabetes Control and Complications Trial (DCCT) reference assay.|baseline and 12, 24 and 36 weeks of the treatment|Intention-to-Treat set|||percentage of HbA1c||Standard Deviation|Mean
2629162|NCT01868542|Secondary|Incidence of Adverse Events|A treatment emergent adverse event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the day of visit 22.(week 20)|Week 20|"Safety analysis set - included all subjects receiving at least one dose of the trial product. Subjects in the safety set contributed to the evaluation as treated."|||events|||Number
2629163|NCT01868542|Secondary|Change in Fasting Plasma Glucose From Baseline|Change in fasting plasma glucose from baseline.|Week 0, week 20|Full analysis set (FAS) - included all randomised subjects.2 subjects withdrew after randomisation in the detemir (2-4-6-8 algorithm) arm.|||mg/dL||Standard Deviation|Mean
2629164|NCT01868542|Secondary|Incidence of Hypoglycaemic Episodes : Nocturnal (23:00-05:59) and Over 24 Hours.|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of the investigational medicinal product (IMP), and no later than the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 inclusive. All plasma glucose values: · equal or below 3.9 mmol/L (70 mg/dL) or · higher than 3.9 mmol/L (70 mg/dL) when they occur in conjunction with hypoglycaemic symptoms.|For 20 weeks of treatment and over 24 hours|Safety Analysis Set (SAS): Included all subjects receiving at least one dose of trial product. Subjects contributed to the evaluation “as treated”.|||Episodes|||Number
2629165|NCT01868542|Secondary|Change in Fasting Plasma Glucose From Baseline|Change in fasting plasma glucose from baseline.|week 0, week 12|Full analysis set (FAS) - included all randomised subjects.2 subjects withdrew after randomisation in the detemir (2-4-6-8 algorithm) arm.|||mg/dL||Standard Deviation|Mean
2629166|NCT01868542|Secondary|Proportion of Subjects Achieving HbA1c Below 7.0%|Responder was a dichotomous endpoint (responder/non-responder) that was defined based on whether a subject had met the ADA HbA1c target at end of trial (HbA1c < 7.0% at end of trial) during 20 weeks of treatment.|Week 20|Full analysis set (FAS) - included all randomised subjects. 2 subjects withdrew after randomisation in the detemir (2-4-6-8 algorithm ) arm.|||percentage (%) of subjects|||Number
2629167|NCT01868542|Secondary|Change in HbA1c|Change in HbA1c at 12 weeks of treatment from visit 2.|Week 0, week 12|Full analysis set (FAS) - included all randomised subjects. 2 subjects withdrew after randomisation in the detemir (2-4-6-8)algorithm arm.|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
2629168|NCT01868542|Primary|Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline.|Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 20 weeks of treatment. Only the subjects in the full analysis set with HbA1c values after 20 weeks of treatment were included.|Week 0, week 20|Full analysis set (FAS) - included all randomised subjects. 2 subjects withdrew after randomisation in the detemir (2-4-6-8 algorithm) arm.|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
2629189|NCT01868425|Secondary|Intraoperative Medication Use: Fentanyl|All participants received standard induction medications.|From induction until arrival in post anesthesia care unit.||||mcg||Standard Deviation|Mean
2629171|NCT01868503|Secondary|Change in the Proportion of BCSCs|Defined as the difference between the percentage of BCSCs before and after treatment. Proportion of biopsy samples that are evaluable for BCSCs will be estimated along with 95% exact confidence intervals. BCSC results will be summarized using medians and interquartile ranges. Changes in BCSCs will be assessed using the Wilcoxon signed rank test.|Baseline to 12 weeks|This outcome was not analyzed due to lack of funding. It may be re-evaluated in the future. Data were not collected and the outcome measure was not analyzed.||||||
2629172|NCT01868503|Secondary|Feasibility of Assessing the Effects of Lapatinib and Radiation Therapy on BCSCs Using Flow Cytometry and SCGEP|Defined as the percentage of biopsy specimens for which the SCGEP assay achieves a non-zero number.|12 weeks|Data were not collected and the outcome measure was not analyzed.||||||
2629173|NCT01868503|Primary|Percentage of Patients Achieving Complete Clinical Response|Complete clinical response will be defined as the absence of tumor on the chest wall, in the treated breast, or in the nodal regions as assessed by clinical examination +/- radiographic imaging (if clinically indicated).|Up to 12 weeks||||Participants|||Count of Participants
2629174|NCT01868477|Secondary|Absolute Change in Hemoglobin (Hb) From Baseline for EPO+DFX at 12 Weeks Arm (Full Analysis Set)|This analysis included patients randomized either to EPO or DFX+EPO at baseline as well as patients who did not have erythroid response at week 12 in the EPO group and switched to combination therapy. The time-course of Hb and its absolute changes from baseline was summarized by descriptive statistics by visit and erythroid response. Patients randomized to EPO and not switching after 12 weeks to EPO+DFX would consist of only responders.|Baseline up to 24 weeks|Number of patients analyzed varied by visit|||g/dL||Full Range|Median
2629175|NCT01868477|Secondary|Absolute Change in Hemoglobin (Hb) From Baseline for Deferasirox + Erythropoietin Alpha Arm (Full Analysis Set)|This analysis included patients randomized either to EPO or DFX+EPO at baseline as well as patients who did not have erythroid response at week 12 in the EPO group and switched to combination therapy.|Baseline up to 24 weeks|Number of patients analyzed varied by visit|||g/dL||Full Range|Median
2629176|NCT01868477|Secondary|Absolute Change in Hemoglobin (Hb) From Baseline for Erythropoietin Alpha Arm (Full Analysis Set)|This analysis included patients randomized either to EPO or DFX+EPO at baseline as well as patients who did not have erythroid response at week 12 in the EPO group and switched to combination therapy.|Baseline up to 24 weeks|Number of patients analyzed varied by visit|||g/dL||Full Range|Median
2629177|NCT01868477|Secondary|Absolute Change in Serum Ferritin up to 24 Weeks for EPO+DFX at 12 Weeks Arm (Full Analysis Set)|Absolute change in serum ferritin from baseline|Baseline up 24 weeks|Number of patients analyzed varied by visit|||ng/mL||Full Range|Median
2629178|NCT01868477|Secondary|Absolute Change in Serum Ferritin up to 24 Weeks for Deferasirox + Erythropoietin Alpha Arm (Full Analysis Set)|Absolute change in serum ferritin from baseline|Baseline up to 24 weeks|Number of patients analyzed varied by visit|||ng/mL||Full Range|Median
2629179|NCT01868477|Secondary|Absolute Change in Serum Ferritin up to 24 Weeks for Erythropoietin Alpha Arm (Full Analysis Set)|Absolute change in serum ferritin from baseline|Baseline up to 24 weeks|Number of patients analyzed varied by visit|||ng/mL||Full Range|Median
2629180|NCT01868477|Secondary|Summary of Erythroid Response Within 24 Weeks in Participants Randomized to EPO at Baseline and Not Switched to EPO+DFX After 12 Weeks of Treatment (Full Analysis Set)|Erythroid response: hemoglobin increase from baseline > = 1.5 g/dL (baseline <11 g/dL). Percentages are based on N. Confidence intervals are calculated using Clopper-Pearson method. Hemoglobin value is at time of first response|baseline up to 24 weeks||||percentage of participants||95% Confidence Interval|Number
2629181|NCT01868477|Secondary|Summary of Erythroid Response in Participants Randomized to EPO Alone at Baseline and Switched to EPO+DFX After 12 Weeks of Treatment (Full Analysis Set)|Erythroid response: hemoglobin increase from baseline > = 1.5 g/dL (baseline <11 g/dL)|Week 13 up to 24 weeks||||participants|||Number
2629182|NCT01868477|Secondary|Absolute Change in Platelets and Neutrophil Levels up to 24 Weeks|Absolute change in platelets and neutrophil levels for participants showing improvement: neutrophil improvement: increase from baseline >0.5 × 10^9/L (baseline = 1.0 × 10^9/L ), platelet improvement: increase from baseline ≥ 30 × 10^9/L (baseline = 100 × 10^9/L)|Baseline up to 24 weeks|Number of patients who met criteria varied across parameters|||10^9 cells/L||Standard Deviation|Mean
2629183|NCT01868477|Secondary|Absolute Change in Hemoglobin Values up to 24 Weeks|Absolute change in hemoglobin values for patients showing improvement: Hemoglobin improvement Hb increase from baseline ≥ 1 g/dL (baseline<11 g/dL)|Baseline up to 24 weeks||||g/dL||Standard Deviation|Mean
2629184|NCT01868477|Secondary|Summary of Hematologic Improvement in Patients Randomized to EPO+DFX and EPO Alone, Within 24 Weeks of Treatment (Full Analysis Set)|Percentage of participants achieving an hematologic improvement defined as: neutrophil improvement: increase from baseline >0.5 × 10^9/L (baseline = 1.0 × 10^9/L ), platelet improvement: increase from baseline ≥ 30 × 10^9/L (baseline = 100 × 10^9/L), hemoglobin improvement: Hb increase from baseline ≥ 1 g/dL (baseline<11 g/dL)|Baseline up to 24 weeks|Number of patients who met criteria varied across parameters|||percentage of participants|||Number
2629185|NCT01868477|Secondary|Absolute Change From Baseline to Post-baseline Value for Hemoglobin(g/dL)(Full Analysis Set)|Hematological response criteria defined as: Erythroid response: hemoglobin (Hb) increase from baseline >= 1.5 g/dL (baseline < 11 g/dL), neutrophil response: increase from baseline >= 100% and increase > 0.5 × 10^9/L (baseline <1 × 10^9/L), platelet response: increase from baseline >= 30 × 10^9/L (baseline <100 × 10^9/L) according to modified IWG 2006 criteria|Baseline up to 24 weeks||||g/dL||Standard Deviation|Mean
2629186|NCT01868477|Primary|Difference in Percentage of Patients Achieving Erythroid Response Within 12 Weeks, by Treatment Group (Full Analysis Set)|Difference in percentage of patients achieving an erythroid response within 12 weeks of treatment between the two arms according to modified IWG 2006 criteria increase in hemoglobin (Hb) ≥ 1.5 g/dL. Erythroid response is defined as the increase in Hb from baseline ≥ 1.5 g/dL. Patients achieving erythroid response at least once within 12 weeks were considered responders|Baseline up to 12 weeks||||percentage of participants||95% Confidence Interval|Number
2629187|NCT01868425|Secondary|Time to Discharge|Time to discharge from the recovery room (Phase I recovery) and the outpatient surgery center (Phase II recovery).|Up to 24 hours following surgery||||minutes||Standard Deviation|Mean
2629188|NCT01868425|Secondary|Number of Participants With Complications From the Procedure||Up to 24 hours following surgery||||Participants|||Count of Participants
2629192|NCT01868425|Secondary|Sedation Scale|Sedation scale measured in recovery room, 1-hr post op, and 24 hrs op. The Sedation Scale is scored from 0-10 where 0 = normal, no sleepier than average, 10 = sleepy, hard to stay awake.|Up to 24 hours following surgery||||score on a scale||Standard Deviation|Mean
2629193|NCT01868425|Secondary|Post-Operative Pruritis Score|Participants will be asked to rate their pruritis on a scale of 0 (no itching) - 10 (worst itchiness) while in post-op recovery room and then at 24 hours post-op via phone call.|Up to 24 hours following surgery||||score on a scale||Standard Deviation|Mean
2629194|NCT01868425|Secondary|Incidence of Post-Operative Pruritus|Pruritus in recovery and through the first 24 hours post-op.|Up to 24 hours following surgery||||Participants|||Count of Participants
2629195|NCT01868425|Secondary|Post-Operative Nausea Scores|Nausea scores will be collected in post-operative recovery and 24 hours later (via phone). The participant will be asked to rate their nausea on a scale of 0 (no nausea) - 10 (worst possible).|Up to 24 hours following surgery||||score on a scale||Standard Deviation|Mean
2629196|NCT01868425|Secondary|Post-Operative Incidence of Nausea|Incidence of nausea as recorded in the electronic medical record (EMR) in the recovery room through the first 24-hrs post-op.|Up to 24 hours following surgery||||Participants|||Count of Participants
2629197|NCT01868425|Secondary|Number of Participants Who Received Medication for Nausea|Number of participant who received medication for nausea prior to discharge and after discharge, up to 24 hours post-op.|Up to 24 hours following surgery||||Participants|||Count of Participants
2629198|NCT01868425|Secondary|Pain Scores During Recovery|Pain scores during recovery period through the first 24 hours of recovery, recorded upon arrival to recovery room, 1-hr post-op, 24-hrs post-op. This outcome reports lowest and highest pain score since discharge to 24 hour phone call. Pain scores are collected verbally on a scale of 0-10 where 10 is the most severe pain.|up to 24 hours postoperatively||||score on a scale||Standard Deviation|Mean
2629199|NCT01868425|Primary|Opioid Consumption in the Immediate Postoperative Period|"This data will be entered into the participants electronic medical record and collected from their chart once the participant has been discharged. The immediate postoperative period covers the participant's entire time in the outpatient surgery center after they have entered the recovery room postoperatively. The amount of time they remain in the outpatient surgery center postoperatively varies from a minimum of 1 hour to a maximum of 10 hours and an average of 4 hours."|Up to 10 hours||||morphine mg equivalents||Standard Deviation|Mean
2629200|NCT01868334|Secondary|Year 2 Pre-post Study: Change From Year 1 in the Percentage of Participants Who Were Vaccinated at the End of Year 2|Outcome listed is total percentage point difference in vaccination rates from end of year 1 to end of year 2|% vaccinated by 1/31/2015||||percent change in vaccination rates|||Number
2629201|NCT01868334|Primary|Year 1 RCCT: Change From Baseline in the Percentage of Participants Who Were Vaccinated at the End of Year 1|Outcome listed is total percentage point difference in vaccination rates from baseline to end of year 1|% vaccinated by 5/31/2014 (Tdap, Pneumococcal); % vaccinated by 1/31/2014 (Influenza)||||percent change in vaccination rates|||Number
2629202|NCT01868243|Secondary|Spontaneous Echo Contrast|Spontaneous Echo Contrast showed in Transesophageal echocardiography|90 days||||participants|||Number
2629203|NCT01868243|Primary|Intracardiac Thrombus|The primary endpoint was the detection of intracardiac thrombus in TEE at the end of follow-up (90 days).|90 days|A total of 34 patients were selected between August 2013 and November 2014 (6 were excluded for previous intracardiac thrombus; 1 for unstable INR control). Of the 27 randomized, 15 were assigned to receive dabigatran and 12 to receive warfarin.|||participants||95% Confidence Interval|Number
2629204|NCT01868165|Primary|Change in Cognitive Function as Measured Using the Extended Mini Mental State Exam|The change in cognitive function measured using the extended mini-mental state exam (this is an extended screening test which assesses several areas of cognitive function, the scale is from 0-100, higher scores are better, those without cognitive impairment would be expected to score close to maximum)|12 months|Regression analysis examining change in cognitive function in older adults taking antihypertensives, results are reported for those taking calcium channel blocker antihypertensives over one year of follow up.|||Change on a scale||95% Confidence Interval|Mean
2629205|NCT01868139|Secondary|Safety of Spray Cryotherapy in This Setting;|Number of participants with adverse events; Number of adverse events within the study|36 months|subject withdrawn from study before outcomes measures could be assessed||||||
2629206|NCT01868139|Secondary|Number of Treatment Sessions Needed for Complete Response in Subjects in Whom the Primary Endpoint is Attained;||12 months|subject withdrawn before outcome measures could be assessed||||||
2629207|NCT01868139|Secondary|Estimate Progression-free Survival in Those Who do Not Achieve Complete Pathologic Response||36 months|subject withdrawn before outcome measures could be assessed||||||
2629208|NCT01868139|Secondary|Estimate Overall Survival||12 months|subject withdrawn before outcome measures could be assessed||||||
2629209|NCT01868139|Secondary|Cancer Recurrence Rate at 12 Months After Treatment||12 months|subject withdrawn before outcome measures could be assessed||||||
2629210|NCT01868139|Secondary|Disease-free Survival at 12 Months After Treatment||12 months|subject withdrawn before outcome measures could be assessed||||||
2629211|NCT01868139|Primary|Response Rate to Therapy|"The primary endpoint is to determine the response rate to spray cryotherapy.~It is hypothesized that one of the two following outcomes will occur:~Complete response to therapy: complete tumor eradication confirmed through histologic examination of biopsy specimens from the targeted esophageal tissue site;~Stable disease: tumor remission is not attained, but disease progression is halted."|5 years|subject withdrawn before outcome measures could be assessed||||||
2629212|NCT01868074|Secondary|Change in CPEI (3mph)|The Center of Pressure Excursion Index (CPEI) is a measurement of the lateral displacement of the center of pressure curve from a reference line drawn from the initial to the final centers of pressure during stance phase of gait, and standardized to the width of the anterior third of the foot during pedobarography.|baseline, 8 weeks postpartum||||ratio||Standard Error|Mean
2629213|NCT01868074|Secondary|Change in Arch Rigidity|The arch rigidity index, a measure of the ability of the foot to maintain the arch when weight-bearing, was determined by dividing the standing AHI by the seated AHI. A value of 1.0 would indicate a perfectly rigid arch, while smaller values would indicate a more flexible arch.|baseline, 8 weeks postpartum||||ratio||Standard Error|Mean
2629216|NCT01868035|Secondary|Number of Participants Converting to Human Anti-Murine (Mouse) Antibody (HAMA) Positivity at Any Follow-up Visit From HAMA Negativity at Baseline|The number of participants who developed human anti-murine (mouse) anibodies (HAMA) after treatment was measured.|Baseline; any follow-up visit (up to 72 months)|ITT Population|||participants|||Number
2629217|NCT01868035|Secondary|Number of Participants Needing Supportive Care at Week 7 and Week 13|During the administration of unlabeled Anti-B1 antibody and Iodine-131 Anti-B1 antibody, emergency support for anaphylaxis, including epinephrine, diphenhydramine, hydrocortisone, a laryngoscope, and an endotracheal tube, was readily available. The use of steroids were discouraged unless other measures were ineffective.|Week 7 and Week 13|ITT Population|||participants|||Number
2629218|NCT01868035|Secondary|Time to Nadir for the Indicated Hematology Toxicities|Hematology toxicities included ANC (calculated), WBC count, platelet count, and hemoglobin. Nadir is defined as the lowest counts (for ANC, WBC, and platelet counts)/concentration (for hemoglobin) that the cells reach after chemotherapy. Time to nadir is defined as the time from Baseline to the lowest value recorded up to 120 days following the therapeutic dose.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population|||days||Standard Deviation|Mean
2629219|NCT01868035|Secondary|Nadir for the Indicated Hematology Toxicities|Hematology toxicities included ANC (calculated), hemoglobin, platelet count, WBC count. Nadir is defined as lowest counts that the cells reach after chemotherapy.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population|||10^3 cells/millimeters cubed (mm^3)||Standard Deviation|Mean
2629220|NCT01868035|Secondary|Time to Recovery From the Indicated Hematology Toxicities|Hematology toxicities included ANC (calculated), WBC count, platelet count, and hemoglobin. Time to recovery to Baseline grade for participants with Grade 0 toxicity at Baseline was defined as the time from the date of the last administration of study drug to the first post-nadir date with Grade 0 toxicity, with no other Grade 1-4 toxicities recorded during the next week. For participants with a Grade 1-4 toxicity at Baseline, time to recovery was defined as the time from the last administration of study drug to the first post-nadir date with a Baseline grade or better, with no other higher grade toxicities recorded during the next week. For participants with a nadir grade less than or equal to the Baseline grade, the time to recovery to the Baseline grade equaled the time to nadir.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population|||days||95% Confidence Interval|Median
2629221|NCT01868035|Secondary|Number of Participants With an Adverse Experience, Including Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily have to have a casual relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or significant worsening of a pre-existing sign or symptom, or disease temporally associated with the use of a medicinal product. An SAE is defined as any experience occurring at any dose that results in the following outcomes: death, a life-threatening adverse experience, in-patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. See the SAE/AE module for a complete list of SAEs/AEs.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population|||participants|||Number
2629222|NCT01868035|Secondary|Total Body Residence Time (TBRT)|TBRT is the time at which the activity of infusion is 37% of that at time zero. Whole body images from anterior and posterior gamma camera scans were collected to assess dosimetry. The assessment of organ dosimetry required gamma camera scans from at least 4 time points. Nuclear medicine reviewers conducted a visual examination of the gamma camera scans and calculated the TBRTs. Residence time is calculated from the rate of total body clearance of iodine I-131 radioactivity during the dosimetric dose. Residence time is a measure of how long the drug resides in the body.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population|||hours||Standard Deviation|Mean
2629223|NCT01868035|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the start of treatment to the first occurrence of treatment withdrawal, decision to seek additional therapy, study removal, disease progression, or death. Duration measures were calculated using Kaplan-Meier techniques. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator. PD is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population|||months||95% Confidence Interval|Median
2629224|NCT01868035|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from the start of treatment to the first documented progression or death. Duration measures were calculated using Kaplan-Meier techniques. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator. PD is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population|||months||95% Confidence Interval|Median
2629225|NCT01868035|Secondary|Duration of Response and Duration of Confirmed Complete Response|Duration of response for all participants with confirmed PR, confirmed CRu, or confirmed CR is defined as the time from the first documented response to the first documented progression. CR is defined as the complete disappearance of all detectable clinical/radiographic evidence of disease, the disappearance of all disease-related symptoms if present before therapy, and the normalization of biochemical abnormalities definitely assignable to NHL. PR is defined as a >=50% decrease in the sum of the perpendicular diameters (SPPD) of splenic and hepatic nodules determined at Baseline. PD is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination. Confirmed response requires that the same or better response be confirmed by two consecutive post-therapy response evaluations at least 4 weeks apart.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population. Only those participants with a confirmed response were analyzed. Duration measures were calculated using Kaplan-Meier techniques.|||months||95% Confidence Interval|Median
2629292|NCT01867580|Primary|Number of Inpatient Operating Room Debridements|Debridement in this outcome refers to surgical removal of non viable tissue performed in an operating room|until the wound is deemed ready for closure or coverage by the investigator up to 64 days|Per-protocol population|||Participants|||Count of Participants
2629226|NCT01868035|Secondary|Number of Participants (Par.) With Confirmed (Con.) Complete Response (CR) Confirmed, Confirmed Complete Response Unconfirmed (CRu), Confirmed Partial Response (PR), Relapse Disease (RD), and Progressive Disease (PD)|CR is defined as the complete disappearance of all detectable clinical/radiographic evidence of disease, the disappearance of all disease-related symptoms if present before therapy, and normalization of biochemical abnormalities definitely assignable to non Hodgkin's lymphoma (NHL). PR is defined as a >=50% decrease in the sum of perpendicular diameters (SPPD) of splenic and hepatic nodules determined at Baseline. SD is defined as less than a PR, but not PD, which is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination. RD is defined as the appearance of any new lesion or an increase of >= 50% in the size of nodules. Confirmed response requires that the same or better response be confirmed by two consecutive post-therapy response evaluations at least 4 weeks apart.|From Baseline until Week 25 and follow-up (up to 130 months)|ITT Population. A con. CR+CRu requires that the best response be con. by the same response or better >=4 weeks apart. The individual rows for con. CR, CRu, and PR represent par. with the best response con. by the same exact response. One par. in the CR+CRu category is not counted in the con. CR category because the CR was not con. by another CR.|||participants|||Number
2629227|NCT01868035|Primary|Number of Participants With the Indicated Grade 4 Hematology Toxicities Following Iodine-131 Anti-B1 Antibody|Hematology parameter grades were summarized according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 2.0. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included absolute neutrophil count (ANC) (calculated) <1000 cells/millimeters cubed (mm^3), white blood cells (WBC) <2000 cells/mm^3, platelets <50000 cells/mm^3, and hemoglobin < 8.0 grams/deciliter.|From Baseline until Week 25 and follow-up (up to 130 months)|Intent-to-treat (ITT) Population: all participants who received study drug|||participants|||Number
2629228|NCT01868022|Secondary|Change From Baseline in Forced Vital Capacity (FVC) in of Arm C Participants With Malignant Pleural Mesothelioma (MPM)|FVC is the total amount of air exhaled during the Forced Expiratory Volume test. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. Assessment of FVC was done on Day 1 of every odd cycle for Arm C participants with MPM. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available as standard deviation could not be calculated for a single participant.|Up to 31 cycles (each cycle was of 21 days)|All Treated Subjects Population|||Liters||Standard Deviation|Mean
2629229|NCT01868022|Secondary|Number of Participants With Relevant Covariates That Influence Exposure of GSK3052230|Relevant covariates included parameters like age, weight and disease related covariates. Plasma GSK3052230 concentration-time data were to be combined with data from other studies to be analyzed using a population PK approach. However, other studies with GSK3052230 were not performed and thus no population PK analyses were done.|Cycle(C)1 Day (D) 1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C1 D8 Pre-dose,end of infusion; C2 D1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C4 D1 Predose, end of infusion;C6 D1 Pre-dose, end of infusion,C12 D1 Pre-dose, end of infusion|Pharmacokinetic Population||||||
2629230|NCT01868022|Secondary|Volume of Distribution of GSK3052230|Serial blood sample were collected at an indicated time points. A nonlinear mixed effects model was used to determine volume distribution. Plasma GSK3052230 concentration-time data were to be combined with data from other studies to be analyzed using a population PK approach. However, other studies with GSK3052230 were not performed and thus no population PK analyses were done.|Cycle(C)1 Day (D) 1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C1 D8 Pre-dose,end of infusion; C2 D1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C4 D1 Predose, end of infusion;C6 D1 Pre-dose, end of infusion,C12 D1 Pre-dose, end of infusion|Pharmacokinetic Population||||||
2629231|NCT01868022|Secondary|Clearance of GSK3052230|Serial blood sample were collected at an indicated time points. A nonlinear mixed effects model was used to determine clearances. The Pharmacokinetic Population (PK) consisted of all participants in the All Treated Subject Population for whom a blood sample for pharmacokinetics was obtained and analyzed. Plasma GSK3052230 concentration-time data were to be combined with data from other studies to be analyzed using a population PK approach. However, other studies with GSK3052230 were not performed and thus no population PK analyses were done.|Cycle(C)1 Day (D) 1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C1 D8 Pre-dose,end of infusion; C2 D1 Pre-dose, End of infusion, 1 and 2 hours post-dose;C4 D1 Predose, end of infusion;C6 D1 Pre-dose, end of infusion,C12 D1 Pre-dose, end of infusion|Pharmacokinetic Population||||||
2629232|NCT01868022|Secondary|Progression Free Survival (PFS) as Assessed by Investigator|PFS is defined as the interval between first dose of GSK3052230 and the earliest date of disease progression or death due to any cause by investigator assessment per RECIST 1.1 (for Arm A and B participants) or modified RECIST (for Arm C participants). For participants who do not progress or die, PFS was censored at the time of last radiological scan. Participants who discontinued study with no post-treatment tumor assessment were censored at date of first dose of study drug. Mean and 95 percent CI has been reported. NA indicates that data were not available as only 1 participant had event, other two censored therefore there is no confidence interval.|Median of 28.5 weeks|All Evaluable Subjects Population|||Months||95% Confidence Interval|Median
2629233|NCT01868022|Primary|Number of Participants With Overall Response Rate (ORR)|Overall Response Rate (ORR) is defined as the percentage of participants achieving a confirmed Complete response (CR) or Partial response (PR) from the start of treatment until disease progression as per RECIST version 1.1 or modified RECIST for participants in Arm C. This was determined based on Investigator assessments of response. 95% confidence intervals (CI) are calculated based on the unconditional exact method. ORR as per RECIST vesrion 1.1 for Arm A and B has been reported. ORR as per RECIST version 1.1 and modified RECIST version 1.1 for Arm C has been reported. The study population used for decision-making at the interim analyses during the dose expansion cohorts of the study arms is termed as the All Evaluable Participants Population. NA indicates 0 participants met ORR criteria therefore no dispersion.|Median of 28.5 weeks|All Evaluable Subjects Population|||Participants|||Count of Participants
2642900|NCT01732796|Secondary|SVR4|Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4).|4 Week (post-treatment)|FAS|||Percentage of participants|||Number
2629234|NCT01868022|Primary|Number of Participants With Best Response|Best response defined as complete response (CR:disappearance of all target. Any pathological lymph nodes < 10 millimeter [mm] in the short axis) or partial response (PR at least a 30 percent decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters), stable disease (SD neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease) or progressive disease (PR at least a 20 percent increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of 5 mm) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST. Best response as per RECIST version 1.1 for Arm A and B participants has been reported. Best response according to RECIST version 1.1 or modified RECIST for Arm C participants has been reported.|Median of 28.5 weeks|All Evaluable Subjects Population|||Participants|||Count of Participants
2629235|NCT01868022|Primary|Number of Participants With Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD)|The MTD is defined as the highest dose level tested at which < 33 percent of participants experience a DLT. In cases when MTD is not reached dose was described as the MFD.|Median of 28.5 weeks|All Treated Subjects Population|||Participants|||Count of Participants
2629236|NCT01868022|Primary|Number of Participants With Hematology Change From Baseline With Respect to the Normal Range|Hematology parameters included platelet Count, red blood cell (RBC) Count, hemoglobin, absolute white blood cell (WBC) Count, absolute neutrophils (Neu), absolute lymphocytes (Lym), absolute monocytes (Mono), absolute eosinophils (Eos), absolute basophils (Baso). Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. Hematology parameters with worst-case change from Baseline with respect to normal range only has been presented. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Median of 28.5 weeks|All Treated Subjects Population|||Participants|||Count of Participants
2629237|NCT01868022|Primary|Number of Participants With the Abnormal Urinalysis Findings|Urinalysis parameters included urine protein, urine glucose, urine ketones and occult blood were assessed. Dipstick test was performed for routine urinalysis. Abnormal values such as trace, 1+, 2+, 3+, 4+, >1000, >=1000, and >10 have been reported.|Up to Cycle 16 (each cycle was of 21 days)|All Treated Subjects Population|||Participants|||Count of Participants
2629238|NCT01868022|Primary|Number of Participants With Clinical Chemistry Changes From Baseline With Respect to the Normal Range|Clinical chemistry parameters included potassium, sodium, chloride (Cl), total carbon dioxide (CO2), total and ionized calcium, magnesium, phosphate, albumin, glucose (fasting), Blood urea nitrogen (BUN), creatinine (Cr), uric acid, creatinine clearance, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatase, Total bilirubin (T. Bil), and Direct bilirubin (D. Bil), total T3 and T4, free T4, amylase, lipase, prothrombin time, partial thromboplastin time, international normalized ratio, and fibrinogen. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. Clinical chemistry parameters with change from Baseline with respect to normal range only has been presented. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Median of 28.5 weeks|All Treated Subjects Population|||Participants|||Count of Participants
2629239|NCT01868022|Primary|Number of Participants With Abnormal Echocardiogram (ECHO) Findings|Echocardiography scans were obtained at given time points using an echocardiogram and the findings for left ventricular ejection fraction (LVEF) were obtained. LVEF values at end of treatment (EOT) were recorded as no change or any increase and any decrease values. Only those participants available at the specified time points were analyzed.|Median of 28.5 weeks|All Treated Subjects Population|||Participants|||Count of Participants
2629240|NCT01868022|Primary|Number of Participants With Clinically Significant Findings for 12-lead Electrocardiogram (ECG)|A single 12-lead ECG was performed at the specified timepoints during the study where the participant was instructed to be in semi-recumbent position for 5 minutes before obtaining the ECG. An ECG machine that automatically calculated the heart rate and measures like the PR, QRS, QT, and corrected QT intervals. Number of participants with worst-case post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported.|Median of 28.5 weeks|All Treated Subjects Population|||Participants|||Count of Participants
2629241|NCT01868022|Primary|Change From Baseline in Temperature|Temperature was measured in a semi-supine position after 5 minutes of rest. Temperature was measured before start of first chemotherapy infusion and within 20 minutes before start of GSK3052230 infusion on Day 1 of every cycle and Baseline. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. The worst-case post-Baseline values has been presented.|Baseline and up to Median of 28.5 weeks|All Treated Subjects Population. Number of par. analyzed > number of par. started in the study, as these were bi-directional vital signs tests. Heart rate had both clinically significant low and high ranges and there were par. who experienced both worst case post-Baseline values.Only those par. available at the specified time points were analyzed.|||Degree Celsius|Temperature readings|Standard Deviation|Mean
2629242|NCT01868022|Primary|Change From Baseline in Heart Rate|Heart rate was measured in a semi-supine position after 5 minutes of rest. Heart rate was measured before start of first chemotherapy infusion and within 20 minutes before start of GSK3052230 infusion on Day 1 of every cycle and Baseline. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. The worst-case post-Baseline values has been presented.|Baseline and up to Median of 28.5 weeks|All Treated Subjects Population. Number of par. analyzed > number of par. started in the study, as these were bi-directional vital signs tests. Heart rate had both clinically significant low and high ranges and there were par. who experienced both worst case post-Baseline values.Only those par. available at the specified time points were analyzed.|||Beats per minute (bpm)|Heart rate readings|Standard Deviation|Mean
2629255|NCT01867710|Secondary|Overall Survival|Overall survival was defined as the time interval from the date of randomization to the date of death from any cause.|Up to 156 weeks|Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment.|||Months||95% Confidence Interval|Median
2629243|NCT01868022|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Blood pressure was measured in a semi-supine position after 5 minutes of rest. Blood pressure was measured before start of first chemotherapy infusion and within 20 minutes before start of GSK3052230 infusion on Day 1 of every cycle and Baseline. Baseline is defined as the most recent, non-missing value prior to or on the first study GSK3052230 treatment dose date. Change from Baseline is calculated as visit value minus Baseline value. The worst-case post-Baseline values has been presented. NA indicates that data were not available as standard deviation could not be calculated for a single participant. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to Median of 28.5 weeks|All Treated Subjects Population|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2629244|NCT01868022|Primary|Number of Participants With Dose-Limiting Toxicities (DLT)|DLT is defined as toxicities due to GSK3052230 or due to the combination of GSK3052230 with chemotherapy within Cycle 1 (first 21 days of period on study) that are unlikely to be due to another cause, such as the known effects of cytotoxics chemotherapy alone, disease progression, or accident, and protocol-specified criteria. Clinically significant toxicities that persist or occur beyond Cycle 1 that the investigator and GlaxoSmithKline (GSK) medical monitor consider dose-limiting may also be designated a DLT for the purpose of establishing Maximum tolerated dose (MTD). Number of participants with DLTs has been reported.|Median of 28.5 weeks|All Treated Subjects Population|||Participants|||Count of Participants
2629245|NCT01868022|Primary|Treatment Duration With GSK3052230|The number of participants administered study treatment were summarized according to the duration of therapy. The extent of treatment exposure is calculated as the number of cycles administered. The duration of exposure to study treatment is calculated from first day to last day of treatment plus 1 day. Median and full range (minimum and maximum) has been reported.|Median of 28.5 weeks|All Treated Subjects Population|||Cycles||Full Range|Median
2629246|NCT01868022|Primary|Number of Participants With Dose Delays|Dose reduction and delays were done due to toxicity, or in the interest of participant's safety per investigator discretion. Requirement for more than 2 dose reductions resulted in permanent discontinuation of chemotherapy. Participants with dose delay has been reported.|Median of 28.5 weeks|All Treated Subjects Population|||Participants|||Count of Participants
2629247|NCT01868022|Primary|Number of Participants With Dose Reduction|Dose reduction and delays were done due to toxicity, or in the interest of participant's safety per investigator discretion. Requirement for more than 2 dose reductions resulted in permanent discontinuation of chemotherapy. Participants with dose reduction has been reported.|Median of 28.5 weeks|All Treated Subjects Population|||Participants|||Count of Participants
2629248|NCT01868022|Primary|Number of Participants Withdrew Due to AEs|An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. The AEs leading to permanent discontinuation from the study has been reported.|Median of 28.5 weeks|All Treated Subjects Population|||Participants|||Count of Participants
2629249|NCT01868022|Primary|Number of Participants With Severe AEs and SAEs|The severity of AEs were graded utilizing National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.3. Grade 1 represents mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 represents moderate; minimal, local or noninvasive intervention indicated. Grade 3 represents severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4 represents life-threatening consequences; urgent intervention indicated. Grade 5 represents death related to AE.|Median of 28.5 weeks|All Treated Subjects Population|||Participants|||Count of Participants
2629250|NCT01868022|Primary|Number of Participants With Non-serious Adverse Events (AEs) and Serious AEs (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, protocol-specific events including drug-induced liver injury with hyperbilirubinaemia, any new primary cancers, cardiac toxicity including Left Ventricular Ejection Fraction (LVEF) changes or treatment emergent cardiac valve toxicity and treatment emergent acute anterior uveitis were categorized as SAE. Participants having non-serious AE or SAE were included in the analysis. The All Treated Subjects Population comprised of all participants who received at least one dose of study treatment.|Median of 28.5 weeks|All Treated Subjects Population|||Participants|||Count of Participants
2629251|NCT01868009|Secondary|Number of Participants With the Indicated Device Preference Based on the Size of the Device|The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the device was summarized by study inhaler use sequence.|up to Study Day 26|PP Population. Only those participants responding to the question regarding the specified attribute were analyzed.|||Participants|||Number
2629252|NCT01868009|Secondary|Number of Participants With the Indicated Device Preference Based on the Number of Steps Needed to Take the COPD Medication|The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the number of steps needed to take the COPD medication was summarized by study inhaler use sequence.|up to Study Day 26|PP Population|||Participants|||Number
2629253|NCT01868009|Primary|Number of Participants With the Indicated Device Preference Based on the Size of the Numbers on the Dose Counter|The number of participants who expressed the indicated device preference (i.e., preference for ELLIPTA inhaler, preference for DISKUS inhaler, and no preference) based on the size of the numbers on the dose counter was summarized by study inhaler use sequence.|up to Study Day 26|Per Protocol (PP) Population: all participants in the Intent-to-Treat (ITT) Population (comprised of all participants who had been randomized and received one dose of at least one study inhaler) who completed at least one question from the seven preference questions|||participants|||Number
2629254|NCT01867710|Secondary|Time to Next Prostate Cancer Therapy|Time to next prostate cancer therapy is defined as the time interval from the date of randomization to the date of initiation of first next therapy for prostate cancer.|Up to 4.9 years|Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment.|||Months||95% Confidence Interval|Median
2629256|NCT01867710|Secondary|Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by 1 Point|Time to deterioration in ECOG Performance Status, the time interval from the date of randomization to the first date in which at least one point change (worsening) in the ECOG is observed during the main study treatment period. The ECOG performance status is a grade scale to measure quality of life (QoL). Scores run from 0 to 5, with 0 denoting perfect health and 5 denoting death.|Up to 156 weeks|Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment.|||Months||95% Confidence Interval|Median
2629257|NCT01867710|Secondary|Time to Opiate Use for Cancer-related Pain|Time to opiate use for cancer-related pain is defined the time interval from the date of randomization to the first date of opiate use for cancer pain.|Up to 156 weeks|Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment.|||Months||95% Confidence Interval|Median
2629258|NCT01867710|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with measurable disease at baseline achieving a complete response (CR) or partial response (PR) according to modified response evaluation criteria in solid tumors (RECIST) criteria. RECIST criteria for CR: disappearance of all target lesions and non-target lesions , any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 millimetre [mm] short axis). PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Up to 4.9 years|Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment. Population included participants with measurable disease at baseline.|||Percentage of participants|||Number
2629259|NCT01867710|Secondary|Time to Prostate-Specific Antigen (PSA) Progression|Time to PSA progression was defined as time interval from the date of randomization to the date of the first prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group 2 (PSAWG2) criteria during the main study treatment period. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.|Up to 156 weeks|Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment.|||Months||95% Confidence Interval|Median
2629260|NCT01867710|Secondary|Progression-Free Survival (PFS)|PFS: Time from randomization to one of following: radiographic progression (RP), clinical progression (CP) or death. RP- per PCWG2 criteria and modified RECIST as time from randomization to one of following: 1) considered to have progressed by bone scan if: a) first scan with >=2 new lesions compared to baseline at <12 weeks from randomization and confirmed by second scan >=6 weeks later with >=2 additional new lesions, b) first scan with >=2 new lesions compared to baseline at >=12 weeks from randomization and new lesions on next bone scan >=6 weeks later; 2) Progression of soft tissue lesions per modified RECIST; CP: cancer pain requiring initiation of chronic use of opiate analgesia (oral use for >=3 weeks; parenteral use for >=7 days), Or immediate need to initiate cytotoxic chemotherapy or either radiation therapy or surgical intervention for complications due to tumor progression, even in absence of RP, Or deterioration in ECOG performance status to grade 3 or above.|Up to 4.9 years|Efficacy analysis set included ITT population- all randomized participants regardless of whether they received any study treatment.|||Months||95% Confidence Interval|Median
2629261|NCT01867710|Secondary|Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score|FACT-P is a 39-item participant rated questionnaire which consists of 5 subscales assessing physical well-being (7 items; score range 0-28), social/family well-being (7 items; score range 0-28), emotional well-being (6 items; score range 0-24), functional well-being (7 items; score range 0-28), prostate-specific concerns (12 items; score range 0-48). Each item rated on 0 to 4 Likert type scale, then combined to produce subscale scores for each domain, as well as global quality of life (QoL) score that ranges from 0 to 156. Higher scores represent better QoL. Additional Concerns subscale has 12 items, each with a score 0-6 making a total subscale range 0-72 (higher scores are better). Missing data imputed as per FACT-P Ver4 scoring system (sum of item scores*number of items in subscale/number of items answered).|Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)|ITT population included all randomized participants regardless of whether they received any study treatment. Here,'n'(number of participants analyzed) signifies the number of participants analyzed in specific category.|||Units on a scale||Standard Deviation|Mean
2629262|NCT01867710|Secondary|Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): EQ-VAS|EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed.|Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)|ITT population included all randomized participants regardless of whether they received any study treatment. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2629263|NCT01867710|Secondary|Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): Index Score|"EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). The descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed."|Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)|ITT population included all randomized participants regardless of whether they received any study treatment. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2629264|NCT01867710|Secondary|Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Interference Subscale|BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions (pain interference). It includes 4 questions that assess pain intensity/severity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-SF scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Interference Index is the mean of the scores for the 7 items of the BPI-SF; range is 0=Does not interfere to 10=Completely interferes. LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed.|Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)|ITT population included all randomized participants regardless of whether they received any study treatment. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2629265|NCT01867710|Secondary|Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Intensity Subscale|BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions (pain interference). It includes 4 questions that assess pain intensity/severity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-SF scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-SF; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed.|Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)|ITT population included all randomized participants regardless of whether they received any study treatment. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2629266|NCT01867710|Secondary|Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Worst Pain|"BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions (pain interference). It includes 4 questions that assess pain intensity/severity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-SF scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Worst pain item has a scale of 0 to 10 with 0 indicating No pain and 10 indicating Pain as bad as you can imagine. Last observation carried forward (LOCF) approach used for endpoint analysis. Last observation defined as last visit with non-missing data for parameter analyzed."|Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of main study treatment period [MSTP])|ITT population included all randomized participants regardless of whether they received any study treatment. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2629267|NCT01867710|Secondary|Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12|The PSA response is defined as a >= 50% decline from baseline according to the adapted Prostate Cancer Working Group 2 (PCWG2) criteria. For a PSA response to be confirmed, an additional PSA measurement obtained 4 or more weeks later has to show >=50% decline from baseline.|Week 12|Intent-to-treat (ITT) population included all randomized participants regardless of whether they received any study treatment. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
2629268|NCT01867710|Primary|Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment|No mineralocorticoid excess is defined as experiencing neither of the 2 mineralocorticoid excess toxicities, that is, neither hypokalemia nor hypertension.|Week 24|Safety population included all randomized and treated participants. Here “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
2629269|NCT01867671|Secondary|Percentage of Participants That Withdrew From the Study|Percentage of participants that withdrew from study participation, listed by study phase (at time of study withdrawal).|Initial Dose Escalation through Week 160 (Tolerance Assessment)||||percentage of participants|||Number
2629270|NCT01867671|Secondary|Highest Tolerated Cumulative Dose|"The highest tolerated cumulative dose of peanut protein during the blinded (masked) oral food challenge (OFC) at Week 160, analyzed within and between both placebo and peanut OIT groups. The highest cumulative dose of peanut protein tolerated for each participant was analyzed as a continuous outcome.~Any randomized participant without an evaluable blinded (masked) OFC was imputed as not tolerant. For the continuous highest cumulative dose endpoint, this is defined as having a highest cumulative dose imputed as zero."|Week 160||||mg protein||95% Confidence Interval|Mean
2629271|NCT01867671|Secondary|Count of Participants With Transient Desensitization|Definition of transient desensitization: A participant who passed the blinded (masked) oral food challenge (OFC) to 10 grams peanut flour (=5 grams peanut protein) at week 134 and failed the week 160 in the Peanut oral immunotherapy (OIT) group.|Week 134, Week 160|Participants randomized to the Peanut Oral Immunotherapy (OIT) group|||Participants|||Count of Participants
2629272|NCT01867671|Secondary|Percentage of Tolerant Participants at Week 160|Definition of Tolerant: A participant who passed the oral food challenge (OFC) to 10 grams of peanut flour (=5 grams of peanut protein).|Week 160||||percentage of participants||95% Confidence Interval|Number
2629273|NCT01867671|Primary|Percentage of Participants Desensitized to Peanut Protein After 134 Weeks of Oral Immunotherapy (OIT)|"Definition of desensitized to peanut: A participant who passed the blinded (masked) oral food challenge (OFC) to10 grams of peanut flour (=5 grams of peanut protein) without significant symptoms.*~*Significant symptoms include hives, wheezing, vomiting, or laryngeal edema."|Week 134||||Percentage of Participants||95% Confidence Interval|Number
2630044|NCT01856686|Primary|Reaction Time at 3 Months|Reaction time during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months||||milliseconds||Standard Deviation|Mean
2629274|NCT01867658|Secondary|Patient Reported Quality of Life as Measured by the SF-36 at Change From Baseline at One(1) Month Follow up|The scale ranges from 0 (minimum score) to 100 (maximum) score. A higher the score represents a more favorable health rating. The SF-36 was completed at baseline before surgery and one month post index procedure; the change calculation for both mental and physical components is based on the difference in scores between these two time points.|Baseline and One (1) Month Follow-up|MITT Population minus 19 subjects with missing data at either baseline or 1 month post-procedure.|||units on a scale||Standard Deviation|Mean
2629275|NCT01867658|Secondary|Duration of Hospitalization (Length of Stay)||Days 0-20|MITT Population minus 2 subjects who died prior to discharge|||Days||Standard Deviation|Mean
2629276|NCT01867658|Secondary|Duration of Chest Tube Drainage||Day 0-46|MITT Population minus 1 subject with missing data|||Days||Standard Deviation|Mean
2629277|NCT01867658|Secondary|Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals||Day 0-46|MITT population minus 1 subject with missing data.|||Days||Standard Deviation|Mean
2629278|NCT01867658|Secondary|Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery||Day 0||||Participants|||Count of Participants
2629279|NCT01867658|Secondary|Percentage of Air Leaks That Are Sealed or Reduced||Day 0|Subjects in the mITT population|||percentage of air leaks|Number of Air Leaks|95% Confidence Interval|Number
2629280|NCT01867658|Secondary|Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up||One (1) month|MITT Population|||percentage of participants||90% Confidence Interval|Number
2629281|NCT01867658|Primary|Rate of Device and/or Procedure-related Adverse Events|The primary outcome of the study is the rate of device- and/or procedure-related adverse events at one month after surgery in subjects using Progel® PALS in a VATS/Robotic procedure. Endpoint analysis of the rate of device- and/or procedure-related adverse events will be based on the Clinical Events Committee (CEC) adjudication of adverse events.|One (1) month follow-up|Number of subjects reflects subjects who have completed 1-month follow-up visit or had device/procedure related AE before discontinuation.|||percentage of participants||90% Confidence Interval|Number
2629282|NCT01867632|Secondary|Number of Participants With Wound Infection|Number of Participants with Wound Infection post cleft palate repair|Within 1 year of surgery||||Participants|||Count of Participants
2629283|NCT01867632|Primary|Fistula Formation|Number of patients who developed post palatoplasty fistula|Within 1 year of surgery||||participants|||Number
2629284|NCT01867606|Secondary|Change in QOL in Patients Who do Not Start Intervention or Discontinue Early, Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale|Analysis will be descriptive in nature to see if these patients have a poorer QOL than patients who stay on study.|Baseline up to 25 months|All evaluable patients who never started intervention or discontinue early. All patients completed the study, no patients are evaluable for this outcome.||||||
2629285|NCT01867606|Secondary|Change in QOL Measured Using the 14-item PQL Tool, Uniscale, and the Previously-validated Symptom Distress Scale|All 14 of the individual items from the PQL tool, along with the 4 additional items after the PQL questions will be analyzed and compared between the 2 intervention arms. Differences between post-randomization and baseline QOL scores will be analyzed and compared between the 2 arms using a Wilcoxon Rank-sum test. Also, other graphical and statistical methods will be used to compare the QOL between the 2 arms over time. For this endpoint, the total QOL score could range from 1 to 140 (0 being the worst and 140 being the best). These scores will be converted to the percentage scale, where a score of 140 will be converted to 100 and a score of 0 will remain as 0. This QOL will be measured weekly for the entire 12 week length of the study and at the end of the intervention. QOL improvement will be defined as at least a 10 point increase in the QOL score from baseline, on the percentage scale.|up to 25 months|All evaluable patients|||Participants|||Count of Participants
2629286|NCT01867606|Secondary|Intervention Compliance Assessed Using the Compliance Questionnaire|The frequency and percentage for each Compliance Questionnaire category will be summarized descriptively by cycle and by intervention arm. In addition, cycle by cycle compliance data will be compared between the 2 arms using a Chi-square test.|up to 25 months||||Participants|||Count of Participants
2629287|NCT01867606|Secondary|Surgical Complication Rates|Compared between the 2 arms using Chi-Square or Fisher's Exact tests.|Up to 1 month post-surgery|All evaluable patients|||Participants|||Count of Participants
2629288|NCT01867606|Secondary|Overall Adverse Event Rates for Grade 2 or Higher Adverse Events, Graded According to the Common Terminology Criteria for Adverse Events Version 4.0|Frequency tables will be reviewed to determine adverse event patterns, this data is reported in the adverse events section of this report. Below is the number of patients that experienced an adverse event greater than or equal to 2.|up to 25 months|All evaluable patients|||Participants|||Count of Participants
2629289|NCT01867606|Primary|Time-to-QOL Improvement Defined as Any Increase in the QOL Score Measured Using the Total Score of the 14-item Postoperative Quality of Life (PQL) Tool|For this endpoint, the total QOL score could range from 1 to 140 (0 being the worst and 140 being the best). The primary analysis will be a comparison of oral SBI vs. placebo using a two-sided log-rank test between the 2 Kaplan-Meier curves.the total score of the 14-item Postoperative Quality of Life (PQL) tool [15] will be used, where the total score could range from 0 to 140 (0 being the worst and 140 being the best). These scores will be converted to the percentage scale, where a score of 140 will be converted to 100 and a score of 0 will remain as 0. This QOL will be measured weekly for the entire 12 week length of the study and at the end of the intervention. QOL improvement will be defined as at least a 10 point increase in the QOL score from baseline, on the percentage scale.|up to 25 months||||Months||95% Confidence Interval|Median
2629290|NCT01867580|Post-Hoc|Number of Inpatient Operating Room Debridements in Surgically Dehisced Wounds||until the wound is deemed ready for closure or coverage by the investigator up to 64 days|This only included those patients with wound etiology of Surgically Dehisced Wounds|||Participants|||Count of Participants
2629291|NCT01867580|Secondary|The Difference in Total Bacterial Counts Measured in Colony Forming Units (CFU) as Determined by Quantitative PCR Analysis.||Immediately following initial post debridement to the first dressing change up to 72 hours|Per-protocol population (some subjects had missing assessments)|||Total Bacterial Counts (Log10 CFU)||Standard Deviation|Mean
2644779|NCT01716104|Secondary|Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline||Baseline and 1, 3, 6 and 12 months|ITT set|||ml/s||Standard Deviation|Mean
2629293|NCT01867515|Primary|Percent Correct Words Identified|The experimental approach compares speech identification performance among younger, normally-hearing listeners, older normally-hearing listeners and hearing-impaired listeners. Tasks will be carried out in quiet and in the presence of continuous, speech-shaped background noise. The investigators compared the understanding of unprocessed stimuli with 1) time-compressed stimuli, 2) time-compressed stimuli expanded in time via gaps and 3) uncompressed stimuli where portions of the signal were replaced with silence. Experimental metrics were percentage of correct/incorrect speech identification in each listening condition.|average of two blocks per condition obtained over the course of up to three 2-hour visits, spaced an average of one week apart||||percentage of words identified||Full Range|Mean
2629294|NCT01867424|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|From date treatment consent signed to date off study, approximately 3 years and 33 days||||Participants|||Count of Participants
2629295|NCT01867424|Secondary|Baseline Serum Prostate-Specific Antigen (PSA) Levels of Patients Who Were Evaluated for Magnetic Resonance (MR) Contrast Enhancement Parameters Following Eovist Injection|Scans with or without endorectal coil were obtained through the prostate gland, bone metastasis or soft tissue metastasis (usually a lymph node) selected as the target lesion as described in primary outcome measure. Then 0.1 ml/kg Eovist was administered intravenously. Scans were correlated to baseline PSA levels.|Baseline|Three patients did not complete the study and are excluded, and two patients were not evaluable due to non-evaluable images.|||ng/mL||Standard Deviation|Mean
2629296|NCT01867424|Secondary|Number of Participants Who Were Evaluated for Magnetic Resonance (MR) Contrast Enhancement Parameters Following Eovist Injection With Respect to Gleason Score|Scans with or without endorectal coil were obtained through the prostate gland, bone metastasis or soft tissue metastasis (usually a lymph node) selected as the target lesion as described in primary outcome measure. Then 0.1 ml/kg Eovist was administered intravenously. Scans were correlated with baseline Gleason score obtained from the prostate biopsy. Gleason score <7 = low grade cancer; Gleason score ≥7 = high grade cancer.|At baseline|Three patients did not complete the study and are excluded, and two patients were not evaluable due to non-evaluable images.|||Participants|||Count of Participants
2629297|NCT01867424|Primary|Uptake and Retention of Eovist in Prostate Cancers|Uptake and retention of Eovist in prostate cancers is measured by the change of magnetic resonance imaging (MRI) parameter values between pre and post injection.|Baseline and 20 minutes after Evoist injection|Three patients did not complete the study and are excluded, and two patients were not evaluable due to non-evaluable images.|||contrast enhancement ratio (CER)||Standard Deviation|Mean
2629298|NCT01867307|Primary|Change From Baseline of Renal Tubular Maximum Reabsorptive Capacity for Glucose (TmG) at End of Empagliflozin Treatment (Day 14)|"Change from baseline of renal tubular maximum reabsorptive capacity for glucose (TmG) at end of empagliflozin treatment (Day 14).~Per-protocol set (PPS): PPS consisted of all subjects and patients in the TS who completed the treatment day 14 clamping study without any relevant deviations either in their treatment regimen or in the performance and timing of the measurements."|Baseline and Day 14|Analysable set (AS): This data set is based on the PPS and excluded all primary endpoint and exploratory endpoint data for one healthy subject due to outlying values that were identified in the subject’s TmG and urine splay data.|||(milligram / minute/ 1.73 square meters)||Standard Deviation|Mean
2629299|NCT01867294|Secondary|Patient Reported Outcomes as Measured by the Change From Baseline in the SKINDEX-16 Total Score (Study II)|Total scores from the SKINDEX-16 will be compared from baseline to week 4. Comparisons between treatment arms will be made by t-tests.|At 4 weeks|Study II was not conducted.||||||
2629300|NCT01867294|Secondary|Incidence of Healthcare Provider Reported Adverse Events (Study II)|All secondary endpoints will be reported descriptively using frequency statistics and single sample t-tests. Outcomes with respect to baseline covariates will also be explored.|At 8 weeks|Study II was not conducted.||||||
2629301|NCT01867294|Secondary|Efficacy of the Spironolactone Treatment to Prevent/Attenuate Rash From EGFR Inhibitors in This Patient Population Defined as Absence of Any Grade 2 or Worse Rash (Study II)|This analysis will be descriptive in nature, and will involve an intent-to-treat analysis at the end of week 8. Patients will be categorized dichotomously according to healthcare provider reported grade 2 or worse rash. The absence of any grade 2 or worse rash will be a success and the existence of any such rash will be a failure. Patients who do not complete the 8 week treatment will be considered a failure. Point estimates and 95% confidence limits will be calculated.|At 8 weeks|Study II was not conducted.||||||
2629302|NCT01867294|Secondary|Efficacy of the Modified Preemptive Therapy Regimen, Calculated and Analyzed Analogously to the Efficacy of the Spironolactone (Study II)|All secondary endpoints will be reported descriptively using frequency statistics and single sample t-tests. Outcomes with respect to baseline covariates will also be explored.|At 4 weeks|Study II was not conducted.||||||
2629303|NCT01867294|Secondary|Efficacy of Spironolactone and Placebo Measured by the Use of the Brief Pictorial Rash Incidence Questionnaire (Study I)|Patients will be dichotomously categorized as a success if no rash is reported and a failure if rash exists at the end of 4 weeks. The number of patients that successfully completed 4 weeks of treatment and reported no rash on the Brief Pictorial Rash Incidence Questionnaire are reported.|At 4 weeks|All patients that began study treatment are included in this analysis.|||participants|||Number
2629304|NCT01867294|Primary|Efficacy of the Spironolactone Treatment to Prevent/Attenuate Rash From EGFR Inhibitors in This Patient Population Defined as Absence of Any Grade 2 or Worse Rash (Study II)|The primary analysis will be descriptive in nature, and will involve an intent-to-treat analysis at the end of week 4. Patients will be categorized dichotomously according to healthcare provider reported grade 2 or worse rash. The absence of any grade 2 or worse rash will be a success and the existence of any such rash will be a failure. Patients who do not complete the 4 week treatment will be considered a failure. Point estimates and 95% confidence limits will be calculated.|At 4 weeks|Study II was not conducted.||||||
2629305|NCT01867294|Primary|Percentage of Patients in the Spironolactone Arm Who Complete the 4-week Study Intervention (Study I)|The number of patients able to complete the 4-week study intervention and the 4-week observation period are reported.|At 4 weeks|All patients that began Study I treatment were included in this endpoint.|||Participants|||Count of Participants
2629306|NCT01867294|Primary|Incidence of Truncal/Extremity Rash of Any Grade in Patients in the Spironolactone Arm (Study I)|Adverse events were collected at the end of each 4-week cycle according to the Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. The number of patients reporting a truncal/extremity adverse event is reported here. The treatment will be considered feasible if at least 50% of patients in the spironolactone arm develop a truncal/extremity rash of any grade at the end of 4 weeks.|At 4 weeks|All patients that began protocol treatment are included in this endpoint.|||Participants|||Count of Participants
2629307|NCT01867294|Primary|Number of Patients Reporting a Grade 2+ Adverse Event Attributed to Spironolactone (Study I)|Adverse events were collected at the end of one 4-week cycle and one 4-week observation period according to the Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. The number of patients reporting a grade 2+ adverse event attributed to spironolactone is reported here.|At 8 weeks|All patients that began study treatment were included in this analysis.|||Participants|||Count of Participants
2629308|NCT01867216|Secondary|Change From Baseline in C-Peptide Area Under the Effective Concentration Curve (AUEC₀₋₁₂) During Mixed Meal Tolerance Test at Day 28||Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12 hours Postdose|All participants who received study drug and had sufficient evaluable c-peptide values.|||picomoles*h per liter (pmol*h/L)||Standard Deviation|Mean
2629309|NCT01867216|Secondary|Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve (AUEC₀₋₂₄) During Mixed Meal Tolerance Test at Day 28||Day 28: Predose, 0.5,1.5, 2.5, 4, 6, 12, 16, 24 hours Postdose|All participants who received study drug and had sufficient evaluable blood glucose values.|||mg*h/dL||Standard Deviation|Mean
2629310|NCT01867216|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at Day 28||Baseline, Day 28|All participants who received study drug and had sufficient evaluable HbA1c values.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2629311|NCT01867216|Secondary|Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY2922470||Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose|All participants who received LY2922470 and had sufficient evaluable Tmax values. For BID arms, Tmax from time 0-6 hours.|||hours||Full Range|Median
2629312|NCT01867216|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470||Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24, 48 hours postdose|All participants who received LY2922470 and had sufficient evaluable Cmax values. For BID arms, Cmax from time 0-6 hours.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2629313|NCT01867216|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) From Time Zero to 24 Hours Postdose (AUC[0-24]) of LY2922470||Day 1: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose and Day 28: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 16, 24 hours postdose|All participants who received LY2922470 and had sufficient evaluable AUC(0-24) values.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2629314|NCT01867216|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module.|Baseline through Study Completion (up to 56 days)|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2629315|NCT01867164|Secondary|Percentage of Participants With Response to Treatment Assessed by Physician|Response to treatment was evaluated by Physician using a 5-point numerical scale: 1=No response (no improvement or condition even worsened); 2=Poor (No symptoms disappeared and symptoms are moderate to severe) 3=Moderate (improvement and symptoms are of moderate intensity); 4=Good (much improvement, but there are still some occasional mild symptoms); 5=Excellent (all symptoms disappeared).|8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure.|||Percentage of Participants|||Number
2629316|NCT01867164|Secondary|Percentage of Participants With Response to Treatment Assessed by Participant|Response to treatment was evaluated by participant using a 5-point numerical scale: 1=No response (no improvement or condition even worsened); 2=Poor (No symptoms disappeared and symptoms are moderate to severe) 3=Moderate (improvement and symptoms are of moderate intensity); 4=Good (much improvement, but there are still some occasional mild symptoms); 5=Excellent (all symptoms disappeared).|8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure.|||Percentage of Participants|||Number
2629317|NCT01867164|Primary|Percentage of Participants With the Presence of Microorganisms (Single-celled, Tiny Organisms That Include Fungi, Bacteria, Viruses) 3 Days After Treatment|Percentage of participants with the presence of microorganisms (Candida albicans, Candida species, Gardnerella vaginalis, Vaginal flora, Lactobacillus species) in the wet mount, KOH, gram stain and vaginal discharge culture (candida and symptomatology) 3 days after treatment.|3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' signifies participants who were evaluated for this outcome measure including the participants for whom no culture was performed.|||Percentage of Participants|||Number
2629318|NCT01867164|Primary|Percentage of Participants With Presence or Absence of Symptoms 8 Days After Treatment|Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.|8 days after treatment (Day 12 for Gynoclin V or Day 18 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in ITT population. Here 'N' specifies participants who were evaluated for this outcome measure.|||Percentage of Participants|||Number
2635873|NCT01798186|Secondary|Subjective VAS Drug Effect|"Visual analog scale (0-100; not at all to extremely) of subjective Drug Effect"|immediately post cannabis exposure.||||mm||Standard Deviation|Mean
2629319|NCT01867164|Primary|Percentage of Participants With Presence or Absence of Symptoms 3 Days After Treatment|Participants were evaluated for presence or absence of symptoms (itching, burning and sudden vulvar pain) in response to treatment.|3 days after treatment (Day 7 for Gynoclin V or Day 13 for Vagitrol V)|Participants who received at least 1 dose of study medication and who were evaluated for efficacy parameters were included in Intent-to-treat (ITT) population. Here 'N' specifies participants who were evaluated for this outcome measure.|||Percentage of Participants|||Number
2629320|NCT01867086|Other Pre-specified|Number of Alive Subjects|Survival status of patients after treatment will be determined.|24 months|1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. After 24 months, subject was not alive. Statistical analysis was not done. This study was terminated.|||Participants|||Count of Participants
2629321|NCT01867086|Secondary|Immune Analysis in Blood|To determine if subjects will have a positive (defined as >10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until 30 days after last dose.|Baseline, End of Treatment (30 days after last dose) up to 12 months|1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. After 12 months, subject had positive ELISPOT response. Statistical analysis was not done. This study was terminated.|||Participants|||Count of Participants
2629322|NCT01867086|Primary|Response Rate|Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.|Up to 12 months|1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. There is no Outcome Measure Data table because Time to Progression (TTP) and Response Rate (RR) were not collected and analyzed. This study was terminated.||||||
2629323|NCT01867086|Primary|Time to Progression (TTP)|Time to progression (TTP) will be determined following Carboplatinum integrated with Vigil vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production. This will be measured from the treatment start date (date of first dose) to either the date the patient is first recorded as having disease recurrence (even if the patient went off treatment because of toxicity), or the date of death if the patient dies due to any causes before progression.|24 months|1 subject was enrolled and started Vigil treatment plus Carboplatinum. This subject did not complete treatment due to disease progression. There is no Outcome Measure Data table because Time to Progression (TTP) and Response Rate (RR) were not collected and analyzed. This study was terminated.||||||
2629324|NCT01867047|Post-Hoc|Length of Stay|Length of stay in days|Discharge from hospital (approximately 5 days)||||Days||Full Range|Median
2629325|NCT01867047|Secondary|Number of Participants With Acute Kidney Injury|Number of participants with acute kidney injury will be recorded.|Discharge from hospital (approximately 5 days)||||Participants|||Count of Participants
2629326|NCT01867047|Secondary|Number of Participants That Received Allogeneic Blood|The number of participants that received allogeneic blood will be recorded.|Discharge from hospital (approximately 5 days)||||Participants|||Count of Participants
2629327|NCT01867047|Secondary|Number of Participants Transferred to Intensive Care Unit (ICU)|The number of participants transferred to Intensive Care Unit (ICU) will be recorded|Discharge from hospital (approximately 5 days)||||Participants|||Count of Participants
2629328|NCT01867047|Primary|Number of Participants Given Vasopressors|The number of participants who received vasopressors.|Discharge from hospital (approximately 5 days)||||Participants|||Count of Participants
2629329|NCT01867047|Primary|Number of Participants With Severe Hypotension|The number of participants with severe hypotension (Systolic Blood Pressure less than 65 mmHG) will be recorded.|From baseline to discharge from hospital (approximately 5 days)||||Participants|||Count of Participants
2629330|NCT01867047|Primary|Number of Participants With Mild Hypotension|The number of participants with mild hypotension (Systolic Blood Pressure (SBP) less than 85 mmHG) will be recorded.|From baseline to discharge from hospital (approximately 5 days)||||Participants|||Count of Participants
2629331|NCT01867021|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV and TIVf|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIV and control.|Day 1 to 7 postvaccination|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Subjects|||Number
2629332|NCT01867021|Secondary|Geometric Mean Ratio of Subjects Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine|Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs against each of three vaccine strains, three weeks after vaccination of TIV and TIVf vaccine (day 22).|Day 22|Analysis was done on the PPS1|||Ratios||95% Confidence Interval|Geometric Mean
2629333|NCT01867021|Secondary|Evaluation of Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIV and TIVf Vaccine|"Percentage of subjects achieving HI seroconversion against each of three vaccine strains was measured three weeks after vaccination of TIV and TIVf vaccine (day 22).~Percentage of subjects who achieved HI titer ≥1:40 against each of three vaccine strains was measured three weeks after one vaccination of TIV and TIVf vaccine.~According to Center for Biologics Evaluation and Research recommendations (CBER 2007), the criterion for seroconversion is considered met if the lower limit of the two-sided 95% CI for the percentage of subjects with HI seroconversion is ≥40% (<65 years) or ≥30% (≥65 years).~As per the CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects who achieved HI titer ≥ 1:40 should be ≥70% (<65 years) or ≥60% (≥65 years)."|Day 22|Analysis was done on the PPS1 for HI Titer ≥1:40 at day 22 and PPS2 for Seroconversion|||Percentages of subjects||95% Confidence Interval|Number
2629346|NCT01866709|Secondary|Change in Serum Sodium, Magnesium, Calcium Levels From Baseline After Administration of SPS.||First 48 hours|Study was prematurely terminated for safety reasons; no statistical analyses were conducted.||||||
2629359|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Adiponectin|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Adiponectin|52 weeks of adalimumab treatment||||log(ug/mL)||Standard Error|Mean
2654578|NCT01634269|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA)||30 days||||cm²||Standard Deviation|Mean
2629334|NCT01867021|Primary|Percentages of Subjects Achieving Seroconversion (SC) in Antibody Titers in the TIV Group Compared With the Corresponding Percentages of Subjects in the TIVf Group for All Three Strains At Day 22, in Healthy Adults Aged ≥50 Years|"Non-Inferiority was measured as the percentages of subjects who achieved seroconversion in HI titers three weeks (day 22) after vaccination of TIV compared with TIVf, against each of three vaccine strains.~Seroconversion is defined as a prevaccination titer <10 and postvaccination HI ≥40 or as a prevaccination titer ≥10 and at minimum four-fold rise in postvaccination antibody titer.~The upper limit of the two-sided 95% CI on the difference between the seroconversion rates (Seroconversion TIVf - SeroconversionTIV) should not exceed 10%."|Day 22|Analysis was done on the PPS2, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at visit 1 and visit 2; and had no major protocol violations as defined prior to analysis|||percentages of subjects||95% Confidence Interval|Number
2629335|NCT01867021|Primary|Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV Group and TIVf Group for All Three Strains, in Healthy Adults Aged ≥50 Years|"Non-inferiority of Postvaccination Hemagglutination Inhibition (HI) Geometric Mean Titers (GMTs) of TIV (Trivalent Subunit Inactivated Influenza Vaccine) Group Over the Corresponding TIVf Group for All Three Strains, three weeks after vaccination (day 22).~The upper limit of the two-sided 95% confidence interval (CI) on the ratio of GMTs (GMT TIVf/GMT TIV) should not exceed the non-inferiority margin of 1.5."|Day 22|Analysis was done on the per-protocol set 1 (PPS1) , ie, the subjects who received the vaccine correctly; provided evaluable serum samples at visit 2; and had no major protocol violations as defined prior to analysis.|||Titers||95% Confidence Interval|Geometric Mean
2629336|NCT01866943|Secondary|Harris Hip Scores|Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.|6 week|Patients undergoing primary total hip arthroplasty.|||units on a scale||Standard Deviation|Mean
2629337|NCT01866943|Secondary|Harris Hip Scores|Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.|2 week|Patients undergoing primary total hip arthroplasty.|||units on a scale||Standard Deviation|Mean
2629338|NCT01866943|Secondary|Harris Hip Scores|Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.|Preoperative|Patients undergoing primary total hip arthroplasty.|||units on a scale||Standard Deviation|Mean
2629339|NCT01866943|Secondary|Mid Thigh Circumference|Measurement of the thigh at the half way point between the prominence of the greater trochanter and the lateral epicondyle of the femur. No data recorded at 2 weeks or 6 weeks for this study population.|Pre Op|Patients undergoing primary unilateral THA.|||centimeters||Standard Deviation|Mean
2629340|NCT01866943|Primary|Estimated Blood Loss|Estimated Blood Loss defined as Pre Op Hgb mins the Post Op Day two Hgb.|Pre Op, Post Op Day 2|Patients undergoing primary unilateral THA. Group membership is unknown as only data available is blinded and de-identified.|||Hemoglobin (grams/deciliter)||Standard Deviation|Mean
2629341|NCT01866826|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|The number of participants with serious and non-serious adverse events that were possibly related to Rifaximin or Placebo as assessed by the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|From baseline until up to approximately 14 weeks|Number of participants analyzed differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.|||Participants|||Count of Participants
2629342|NCT01866826|Secondary|Changes in Cellular Markers of Immune Activation Between the Placebo and Rifaximin Phases of the Study|Changes in cellular markers of immune activation (IA) is defined as changes in the percentage of cluster of differentiation 4 (CD4) + or cluster of differentiation 8 (CD8)+ T cells that express human leukocyte antigen - antigen D Related (HLA-DR) and cluster of differentiation 38 (CD38). Differences will be tested by using both the Wilcoxon and the t-test.|Between Day 28 of Treatment Phase 1 and Day 28 of Treatment Phase 2|46 randomized participants, 37 had evaluable results. Number of participants analyzed differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.|||percentage of lymphocytes||Standard Deviation|Mean
2629343|NCT01866826|Secondary|Changes in Soluble Markers of Inflammation Between the Placebo and Rifaximin Phases of the Study|Changes in soluble marker of inflammation Interleukin 6 (IL6) between the placebo and rifaximin phases of the study. Differences will be tested by using both the Wilcoxon and the t-test.|Between Day 28 of Treatment Phase 1 and Day 28 of Treatment Phase 2|46 randomized participants, 37 had evaluable results. Number of participants analyzed differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.|||picograms/milliliter||Standard Deviation|Mean
2629344|NCT01866826|Secondary|Number of Participants With Viral (HIV-1)-Ribonucleic Acid (RNA) Elevated by Greater Than 50 Copies/ml Plasma at the End of the Rifaximin or Placebo Phase|HIV-1-RNA levels were assessed by using the single copy assay or the traditional HIV Branched Deoxyribonucleic Acid bDNA assay to determine elevations in HIV-1 RNA >50 copies/ml plasma at the end of the Rifaximin or placebo phase. Differences were tested by using both the Wilcoxon and the t-test.|Between Day 28 of Treatment Phase 1 and Day 28 of Treatment Phase 2|Number of participants analyzed differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.|||Participants|||Count of Participants
2629345|NCT01866826|Primary|Changes in Soluble Cluster of Differentiation 14 (sCD14) Levels Between the Placebo and Rifaximin Phases of the Study|One sample Wilcoxon statistic was applied to evaluate the difference on treatment phases between the placebo and Rifaximin.|Between Day 28 of Treatment Phase 1 and Day 28 of Treatment Phase 2|46 randomized participants, 37 had evaluable results. Number of participants analyzed differ from Participant Flow because it represents the cumulative number of participants analyzed per Arm/Group for this outcome measure.|||mcg/mL||Inter-Quartile Range|Mean
2629347|NCT01866709|Primary|Change in Serum Potassium Levels From Baseline After Administration of Sodium Polystyrene Sulfonate (SPS) Three Times a Day Without Co-administration of Sorbitol; Determine Incidence of Adverse Events.|To perform a controlled evaluation of the safety and efficacy of 15g of SPS administered 3 times daily for 48 hours (6 doses) in patients with hyperkalemia (serum potassium levels between 5.0 - 6.5 mmol/l) at baseline.|First 48 hours|Study prematurely terminated for safety reasons; no statistical analyses were conducted.||||||
2629348|NCT01866592|Secondary|Change in Patient-Reported Quality of Life Outcomes - International Physical Activity Questionnaire (IPAQ)|"IPAQ is an instrument designed primarily for population surveillance of physical activity among adults with activity measured in metabolic equivalent (MET)-minutes per week.~Per Office of Disease Prevention and Health Promotion's Physical Activity Guidelines:~A range of 500 to 1,000 MET-minutes of activity per week provides substantial [health] benefit, and amounts of activity above this range have even more benefit. Amounts of activity below this range also have some benefit. The dose-response relationship continues even within the range of 500 to 1,000 MET-minutes, in that the health benefits of 1,000 MET-minutes per week are greater than those of 500 MET-minutes per week.~If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group)."|52 weeks (continuation group) or 64 weeks (crossover group)||||MET-minutes per week||95% Confidence Interval|Mean
2629349|NCT01866592|Secondary|Change in Patient-Reported Quality of Life Outcomes - MEDFICTS Dietary Assessment|"Patient reported dietary outcomes will be assessed using MEDFICTS (Meats, Eggs, Dairy, Fried foods, fat In baked goods, Convenience foods, fats added at the Table, and Snacks), a brief dietary assessment instrument. This assessment looks at eight different categories of foods and assigns points by type of food and serving size ranging from 0 points (do not consume that food group) to 21 points (consume food group, largest serving size). Your final score is the total of all points for all food categories.~If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group)."|52 weeks (continuation group) or 64 weeks (crossover group)||||units on a scale||95% Confidence Interval|Mean
2629350|NCT01866592|Secondary|Change in Patient-Reported Quality of Life Outcomes - Dermatology Life Quality Index (DLQI)|"The DLQI is calculated by summing the score of 10 questions regarding impact of skin condition on daily life resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.~If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group)."|52 weeks (continuation group) or 64 weeks (crossover group)||||units on a scale||95% Confidence Interval|Mean
2629351|NCT01866592|Secondary|Change in Patient-Reported Quality of Life Outcomes-EuroQol EQ-5D|EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a scale ranging from 1 (no health state problem) to 3 (extreme health state problems). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale ranging from 0, worst health state, to 100, best health state. A scoring function is used to assign a value (i.e., EQ-5D™ index score) to self-reported health states from a set of population-based preference weights. For the U.S. general population, the possible EQ-5D index scores range from -0.11 to 1.0 where 0.0 = death and 1.0 = perfect health.|52 weeks (continuation group) or 64 weeks (crossover group)||||units on a scale||95% Confidence Interval|Mean
2629352|NCT01866592|Secondary|Safety/Adverse Events|Safety will be assessed by evaluating all subject reported adverse events through the duration of the study.|Baseline - Week 52||||Participants|||Count of Participants
2629353|NCT01866592|Secondary|Psoriasis Activity (PASI and PGA)|"Change in psoriasis activity will be assessed using the following standardized measurement tools for psoriasis: Psoriasis Area and Severity Index (PASI) and Physician's Global Assessment (PGA). PASI combines the assessment of the severity of lesions and the area affected into a single score with range 0 (no disease) to 72 maximal disease. The PGA is an average assessment of all psoriatic lesions based on erythema, scale, and induration with score range 0 (no disease/clear) to 5 (maximal disease).~If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group)."|52 weeks (continuation group) or 64 weeks (crossover group)||||Participants|||Count of Participants
2629354|NCT01866592|Primary|Change in Cardiometabolic Biomarker - GlycA|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - GlycA|52 weeks of adalimumab treatment||||log(pg/mL)||Standard Error|Mean
2629355|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Interleukin 6|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Interleukin 6|52 weeks of adalimumab treatment||||log(pg/mL)||Standard Error|Mean
2629356|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Tumor Necrosis Factor-Alpha|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Tumor Necrosis Factor-Alpha|52 weeks of adalimumab treatment||||log(pg/mL)||Standard Error|Mean
2629357|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log C-reactive Protein|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log C-reactive protein|52 weeks of adalimumab treatment||||log(pg/mL)||Standard Error|Mean
2629358|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Leptin|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Leptin|52 weeks of adalimumab treatment||||log(pg/mL)||Standard Error|Mean
2637096|NCT01785134|Primary|Insulin Sensitivity at 2 Years|Insulin sensitivity measured by hyperinsulinemic euglycemic clamp|2 years postoperative||||glucose/kg body weight/min||Standard Deviation|Mean
2629360|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Insulin|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Insulin|52 weeks of adalimumab treatment||||log(pg/mL)||Standard Error|Mean
2629361|NCT01866592|Primary|Change in Cardiometabolic Biomarker - High-density Lipoprotein Particle|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - High-density lipoprotein particle|52 weeks of adalimumab treatment||||umol/L||Standard Error|Mean
2629362|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Low-density Lipoprotein Particle|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Low-density lipoprotein particle|52 weeks of adalimumab treatment||||nmol/L||Standard Error|Mean
2629363|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Cholesterol Efflux|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Cholesterol Efflux|52 weeks of adalimumab treatment||||no units||Standard Error|Mean
2629364|NCT01866592|Primary|Change in Cardiometabolic Biomarkers: - Total Cholesterol|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and the start of adalimumab - Total Cholesterol|52 weeks of adalimumab treatment||||mg/dL||Standard Error|Mean
2629365|NCT01866592|Primary|Change in Cardiometabolic Biomarker - GlycA|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - GlycA If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||log(pg/mL)||Standard Error|Mean
2629366|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Interleukin 6|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Interleukin 6 If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||log(pg/mL)||Standard Error|Mean
2629367|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Tumor Necrosis Factor-Alpha|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Tumor Necrosis Factor-Alpha If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||log(pg/mL)||Standard Error|Mean
2629368|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log C-reactive Protein|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log C-reactive protein If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||log(pg/mL)||Standard Error|Mean
2629369|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Leptin|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Leptin If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||log(pg/mL)||Standard Error|Mean
2629370|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Adiponectin|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Adiponectin If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||log(ug/mL)||Standard Error|Mean
2629371|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Log Insulin|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Log Insulin If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||log(pg/mL)||Standard Error|Mean
2629372|NCT01866592|Primary|Change in Cardiometabolic Biomarker - High-density Lipoprotein Particle|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - High-density lipoprotein particle If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||nmol/L||Standard Error|Mean
2629373|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Low-density Lipoprotein Particle|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Low-density lipoprotein particle If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||nmol/L||Standard Error|Mean
2637097|NCT01785095|Secondary|Total Dose of FSH Units Used.||after 2 weeks of treatment||||IU||Standard Deviation|Mean
2629374|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Cholesterol Efflux|"The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: [(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)].~If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group)."|52 weeks (continuation group) or 64 weeks (crossover group)||||no units||Standard Error|Mean
2629375|NCT01866592|Primary|Change in Cardiometabolic Biomarker - Total Cholesterol|Change in metabolic, lipid, and inflammatory biomarker levels between week 52 of the adalimumab treatment period and baseline assessments from the VIP trial - Total Cholesterol. If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||mg/dL||Standard Error|Mean
2629376|NCT01866592|Primary|Change in Vascular Inflammation|Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between week 52 of the adalimumab treatment period and start of adalimumab.The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUIV mean yielding a target to background ration (TBR).|52 weeks of adalimumab treatment||||percentage change||95% Confidence Interval|Number
2629377|NCT01866592|Primary|Change in Vascular Inflammation|Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between week 52 of the adalimumab treatment period and baseline scans (prior to randomization in the VIP Trial). The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUIV mean yielding a target to background ration (TBR). If subjects were randomized to adalimumab in the VIP Trial, the time frame is a total of 52 weeks (continuation group). If subjects were randomized to placebo or phototherapy in the VIP Trial, additional 12 weeks added to the time frame for a total of 64 weeks (crossover group).|52 weeks (continuation group) or 64 weeks (crossover group)||||percentage change||95% Confidence Interval|Number
2629378|NCT01866423|Secondary|Number of Participants With Grade 3 or Higher Toxicity|Summary of grade 3 (per Common Terminology Criteria for Adverse Events (CTCAE v4.0) or higher toxicities which generally is described as a severe reaction or symptom.|30 days|Tracked during treatment period until 30 days after last dose of study drug.|||Participants|||Count of Participants
2629379|NCT01866423|Secondary|Duration of Response Using RECIST Version 1.1 and PCWG2 Criteria|Response will be tabulated descriptively with 95% CIs and Kaplan-Meier survival curves, as appropriate.|Up to 3 years|Only 4 patients was accrued to this trial. No data analysis was performed.||||||
2629380|NCT01866423|Secondary|Overall Response Rate Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and PCWG2 Criteria|Response will be tabulated descriptively with 95% confidence intervals (CIs) and Kaplan-Meier survival curves, as appropriate.|Up to 3 years|Only 4 patients was accrued to this trial. No data analysis was performed.||||||
2629381|NCT01866423|Secondary|Absolute Change in PSA|Values will be tabulated as outlined in the PCWG2 criteria and presented as Kaplan-Meier survival curves, as appropriate.|Baseline to 24 weeks|Only 4 patients was accrued to this trial. No data analysis was performed.||||||
2629382|NCT01866423|Secondary|Best PSA Response|Values will be tabulated as outlined in the PCWG2 criteria and presented as Kaplan-Meier survival curves, as appropriate.|Up to 24 weeks|Only 4 patients was accrued to this trial. No data analysis was performed.||||||
2629383|NCT01866423|Primary|PSA Response, Defined as Occurrence of PSA Decline to Greater Than or Equal to 50% From Baseline|Standard descriptive methods will be used to summarize PSA. Values will be tabulated as outlined in the Prostate Cancer Working Group 2 (PCWG2) criteria and presented as Kaplan-Meier survival curves, as appropriate.|At 12 weeks|Only 4 patients were accrued to this trial. No data analysis was performed.||||||
2629384|NCT01866423|Primary|Androgen Receptor (AR) Protein Expression Levels in CTCs|The two-sample t-test will be used. Once association between AR protein expression levels and response is established, graphical methods such as receiver-operator curves (ROC) or more quantitative methods such as the maximal chi-square method to determine whether there might be a cut-point with either great sensitivity or great specificity (or both) for identifying a cohort with either a high or low likelihood of prostate-specific antigen (PSA) response.|Up to 4 weeks|Only 4 patients were accrued to this trial. No data analysis was performed.||||||
2629385|NCT01866410|Other Pre-specified|Changes in HGF Levels||Baseline up to 6 months after last study treatment|||||||
2629386|NCT01866410|Other Pre-specified|Changes in VEGF Levels||Baseline up to 6 months after last study treatment|||||||
2629387|NCT01866410|Other Pre-specified|Overall Survival by T790M Mutation Status|Estimated using the product-limit method of Kaplan and Meier.|Until death from any cause, up to 2 years||||months||95% Confidence Interval|Median
2629388|NCT01866410|Other Pre-specified|Progression-free Survival by T790M Mutation Status|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. DNA was analyzed for the presence of the T790M point mutation.|Until disease progression or death from any cause, up to 2 years||||months||95% Confidence Interval|Median
2629389|NCT01866410|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Until death from any cause, up to 2 years||||months||95% Confidence Interval|Median
2629390|NCT01866410|Secondary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Until disease progression or death from any cause, up to 2 years||||months||95% Confidence Interval|Median
2629391|NCT01866410|Secondary|Best Response Patient Count|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), ≥ 20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest diameter recorded or the appearance of one or more new lesions; Stable Disease (SD), Neither CR, PR or PD.|Up to 2 years||||Participants|||Count of Participants
2629392|NCT01866410|Secondary|Number of Adverse Events|Grade 3 & 4 adverse events attributed to treatment agents. Events are graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.|Up to 2 years||||Participants|||Count of Participants
2629393|NCT01866410|Secondary|Percentage of Patients With a Greater Than 30% Increase in Tumor Doubling Time|Tumor doubling time was estimated using an exponential growth model. Specifically, the pre-progression scan, and the baseline scan were used to estimate the doubling time prior to enrollment, td = log(2)∗1time/1log(tumor size) [derivation, S(t) = S(to)∗2∧[(t−to)/td] for a parameterization of exponential growth with a doubling time of td. Taking the logarithm on both sides: log(S(t))-log(S(to)) = log(2)∗(t − to)/td or td = log(2)∗(t − to)/[log(S(t))-log(S(to))] = log(2)∗1time/1log(S)], the baseline scan and first evaluation scan were used to determine the doubling time. Based on pre-planned protocol assessment, we estimated the percent of patients that experienced a slowing of tumor kinetics (a 30% increase in the length of time for tumor doubling) based on RECIST v1.1 measurements. Patients who did not get a scan on study, and patients whose pre-progression scans were missing or whose pre-progression tumor size was zero or whose tumor was decreasing prior to enrollment were excluded.|Up to 2 years||||percentage of participants||95% Confidence Interval|Number
2629394|NCT01866410|Primary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 2 years||||percentage of participants||95% Confidence Interval|Number
2629395|NCT01866319|Secondary|Overall Response Rate (ORR)|"ORR was defined as the percentage of the participants with a best tumor response of complete response (CR) or partial response (PR) based on blinded independent central radiologic and clinical review using RECIST 1.1. CR was defined as disappearance of all target lesions with any pathological lymph nodes having a reduction in short axis to <10 mm. PR was defined as a 30% or greater decrease in the sum of diameters of target lesions.~Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)"|Up to 2 years|The ITT population, comprising all participants randomized to a study arm; data collected through 3 September 2014.|||Percentage of Participants||95% Confidence Interval|Number
2629396|NCT01866319|Primary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. The reported percentage is estimated using a product-limit (Kaplan-Meier) method for censored data; for participants whose survival data was obtained after the data cut-off date for the interim analysis, data were censored at the date of cut-off (3 March 2015). Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1).|Month 12|The ITT population, comprising all participants as randomized to a study arm; data collected up to 3 March 2015.|||Percentage of participants||95% Confidence Interval|Number
2629397|NCT01866319|Primary|Progression-free Survival (PFS)|"PFS was defined as the time from randomization to the first documented disease progression, based on blinded independent central radiologic and clinical review using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), or death due to any cause, whichever occurred first. Disease progression was defined as a 20% or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5mm or the appearance of new lesions.~Statistical testing was stratified by line of therapy (1st vs. 2nd), programmed cell death ligand 1 (PD-L1) status (positive vs. negative) and Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1)"|Up to 2 years|The ITT population, comprising all participants as randomized to a study arm; data collected up to 3 September 2014.|||Months||95% Confidence Interval|Median
2629398|NCT01866306|Secondary|Mean Change From Baseline in TWA Asthma Control Diary (ACD) Score of Asthmatic Participants on Days 3 to 10 (Part 2)|The ACD contains seven symptom questions (nocturnal awakening, waking in the morning with symptoms, activity limitation, shortness of breath and wheezing) which are answered on rising in the morning and retiring at bedtime. Missing scores are imputed by linear interpolation or extrapolation. Daily ACD score was fit by a Bayesian hierarchical longitudinal model with participant-specific intercept and a fixed categorical effect for day. All baseline (day -7 to day -1) ACD scores are assumed to be with equal mean. The ACD score is the sum of responses to the seven questions, with answers on a 7-point scale (0= no impairment; 6 = maximum impairment) with the score ranging from 0 to 42, and higher scores indicating greater impairment. The 95% Confidence Interval actually refers to a 95% Credible Interval. The mean percent increase is anticipated to be different from zero.|Baseline and Days 3 to 10|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 1 were not analyzed; one participant who received a viral dose of 67 TCID 50, was included in the analysis.|||Score on a scale||95% Confidence Interval|Mean
2629399|NCT01866306|Secondary|Mean Percent Change From Baseline in Maximum Drop FEV1 of Asthmatic Participants (Part 2)|Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. The FEV1 readings on the evenings of sputum inductions were excluded from the analyses. The percent decrease of the lowest FEV1 measurement after viral challenge compared to the TWA of the baseline FEV1 is presented. The 95% Confidence Interval actually refers to a 95% Credible Interval. The mean percent decrease is anticipated to be different from zero.|Baseline and up to day 7|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 1 were not analyzed; one participant who received a viral dose of 67 TCID 50, was included in the analysis.|||Percent change||95% Confidence Interval|Mean
2631300|NCT01845831|Secondary|Number of Participants With a Hypoglycemic Event|The number of participants who had a hypoglycemic event during hospitalization.|Duration of Hospitalization (Up to 10 Days)||||Participants|||Count of Participants
2629400|NCT01866306|Primary|Number of Asthmatic Participants Demonstrating at Least 10^3 Copies/ml of Viral RNA in Nasal Lavage Fluid on Days 1 to 14 (Part 1)|Viral RNA was measured by real time reverse transcriptase polymerase chain reaction (qRT-PCR) from nasal lavage fluid collected on day 3 and day 7 from asthmatic participants, and the number of participants with at least 10^3 copies/ml was determined.|Days 1 - 14|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Healthy participants, and participants from Part 2 were not analyzed.|||Participants|||Number
2629401|NCT01866306|Primary|Change From Baseline in Mean Maximum Jackson Cold Symptom Score (CSS) on Days 1 to 14 in Asthmatic Participants (Part 1)|Asthmatic participants from Part 1 were treated with RV16UB virus, and challenge induced upper airway symptoms were monitored with a diary recording CSS. The CSS measures 8 cold symptoms, with each symptom scored from 0 (absent) to 3 (severe). The total score ranges from 0-24, with higher scores reflecting greater severity, and a positive change from baseline indicating worsening symptoms.|Baseline and Days 1 - 14|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Healthy participants, and participants from Part 2 were not analyzed.|||Score on a scale||Standard Deviation|Mean
2629402|NCT01866306|Primary|TWA Percent CFB in Evening FEV1 in Asthmatic Participants on Days 1-7 (Part 2)|Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. FEV1 assessments obtained between 3 pm to next day 3 am were counted as evening measurements. The TWA CFB evening FEV1 on days 1-7 was calculated as the difference of the mean of estimated day 1-7 evening FEV1 value and the corresponding estimated baseline value. The FEV1 readings on the evenings of sputum inductions were excluded from the analyses. The 95% Confidence Interval actually refers to a 95% Credible Interval. The anticipated mean reduction from baseline is 10%.|Baseline and Days 1- 7|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 1 were not analyzed; one participant who received a viral dose of 67 TCID 50, was included in the analysis.|||Percent change||95% Confidence Interval|Mean
2629403|NCT01866306|Primary|Time -Weighted Average (TWA) Percent Change From Baseline (CFB) in Morning FEV1 in Asthmatic Participants on Days 1-7 (Part 2)|Log-transformed FEV1 data were fit by Bayesian hierarchical longitudinal models, with a random participant effect and a fixed categorical effect for day. All baseline (day -7 to day -1) FEV1 were assumed to be with equal mean. FEV1 assessments obtained between 3 am to 3 pm were counted as morning measurements. The TWA CFB morning FEV1 on days 1-7 was calculated as the difference of the mean of estimated day 1-7 morning FEV1 value and the corresponding estimated baseline value. The 95% Confidence Interval actually refers to a 95% Credible Interval. The anticipated mean reduction from baseline is 10%.|Baseline and Days 1 - 7|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 1 were not analyzed; one participant who received a viral dose of 67 TCID50, was included in the analysis.|||Percent change||95% Confidence Interval|Mean
2629404|NCT01866306|Primary|Number of Asthmatic Participants Treated With a Viral Dose of 100 TCID50 With Challenge Induced Upper Airway Symptoms (Part 1)|Asthmatic participants from Part 1 were treated with RV16UB virus at a dose of 100 TCID50, and challenge induced upper airway symptoms were monitored with a diary recording Jackson Cold Symptom Score (CSS). The CSS measures 8 cold symptoms, with each symptom scored from 0 (absent) to 3 (severe). The total score ranges from 0-24, with higher scores reflecting greater severity. The number of participants with a CSS score equal or greater than 3 for two days in a row are presented.|Day 1 up to Day 7|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Healthy participants, asthmatics treated with a viral dose of 10 TCID 50, and participants from Part 2 were not analyzed.|||Participants|||Number
2629405|NCT01866306|Primary|Number of Participants With Serious Adverse Events (SAE) (Parts 1 and 2)|A SAE is any adverse event occurring at any dose or during any use of the Sponsor's product that: results in death; is life threatening; results in persistent or significant disability/incapacity; results in or prolongs an existing in-patient hospitalization; is a congenital anomaly/birth defect; is a cancer; is associated with an overdose; is another important medical event.|Up to Day 24|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model.|||Participants|||Number
2629406|NCT01866306|Primary|Number of Healthy and Asthmatic Participants With Events of Clinical Interest (ECI) (Part 1)|ECI are selected non-serious and serious adverse events which include the following: an overdose of Sponsor's product; requirement for systemic steroids to treat asthma exacerbation related to virus challenge; acute reaction to virus challenge, confirmed through repeat measurement and when considered potentially associated with administration of virus; specified vital sign findings within 4hr of challenge; specified symptom findings within 24hr of challenge; >20% decrease in Forced Expiratory Volume in 1 second (FEV1) relative to baseline within 4hr of challenge; dyspnea associated with drop in FEV1 (within 4hr of challenge) that is unresponsive to a bronchodilator rescue agent within 20 minutes; Grade 2+ deviation from normal values of liver-related laboratory parameters at any time between challenge and day 14.|Up to Day 24|Participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of viral challenge, according to the underlying scientific model. Participants from Part 2 were not analyzed.|||Participants|||Number
2629407|NCT01866293|Secondary|Duration of Response (DOR)||1 year|9 participants are evaluable. 2 participants never started treatment.|||days||Full Range|Median
2629408|NCT01866293|Secondary|Time to Progression (TTP)||1 year|9 participants are evaluable. 2 participants never started treatment.|||days||Full Range|Median
2629409|NCT01866293|Secondary|Safety and Toxicity in This Patient Population|Safety assessments and toxicity grading will follow CTCAE Version 4 Grade|1 year||||Participants|||Count of Participants
2629410|NCT01866293|Secondary|Overall Response Rate|IMWG Criteria for Response, Progression and Relapse in Multiple Myeloma Patients|1 year|9 participants are evaluable. 2 participants never started treatment.|||Participants|||Count of Participants
2629412|NCT01866163|Secondary|m-PASI at Week 1|"The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI).~m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI.~The m-PASI score range from 0 (best) to 64.8 (worst)."|1 week|All randomised subjects were included in the full analysis set and analysed for efficacy.|||Scores on a scale||95% Confidence Interval|Mean
2629413|NCT01866163|Secondary|m-PASI at Week 4|"The investigator assessed the extent and severity of the three clinical signs (redness, thickness, and scaliness) on the arms, trunk and legs. These assessments were converted to an Modified Psoriasis Area and Severity Index (m-PASI).~m-PASI (excluding head) assessed at week 4 (adjusted for the effect of (pooled) centre and baseline m-PASI.~The m-PASI score range from 0 (best) to 64.8 (worst)."|4 weeks|All randomised subjects were included in the full analysis set and analysed for efficacy.|||Scores on a scale||95% Confidence Interval|Mean
2629414|NCT01866163|Primary|Treatment Success According to IGA|"Subjects with 'treatment success' ('clear' or 'almost clear' for subjects with at least moderate disease at baseline, 'clear' for subjects with mild disease at baseline) according to the Investigators' global assessment of disease severity (IGA) at Week 4.~The 5 point IGA scale: 1 = clear, 2 = almost clear, 3 = mild, 4 = moderate and 5 = severe"|4 weeks|All randomised subjects were included in the full analysis set and analysed for efficacy.|||percentage of subjects|||Number
2629415|NCT01866150|Secondary|Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment|The 28 joints to be assessed for swelling were shoulder, elbow, wrist, MCP joints 1-5, PIP joints 1-5, and knee on both sides of the body. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data. Here, 'n' signifies number of participants with available data at specified category.|||swollen joints||Standard Deviation|Mean
2629416|NCT01866150|Secondary|Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.|The 28 joints to be assessed for tenderness were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.|Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data. Here, 'n' signifies number of participants with available data at specified category.|||tender joints||Standard Deviation|Mean
2629417|NCT01866150|Secondary|Average Methotrexate Dose of Participants on Biological Combination Treatment||Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Participants in biologic combination group from All Participants Entered Analysis Set. Number of participants analyzed=participants with available data for methotrexate dose.|||milligrams per week||Standard Deviation|Mean
2629418|NCT01866150|Secondary|Duration of Treatment|Drug retention was defined as the total duration of time in months the participant was on treatment (combination therapy or monotherapy). The duration was the time in months between the start date of biologic therapy to the date of most recent visit.|Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data for duration of treatment.|||months||Standard Deviation|Mean
2629419|NCT01866150|Secondary|Percentage of Participants by Category of DAS28 Score and Timepoint|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and either ESR or CRP for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.|Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for the endpoint. Here, 'n' signifies number of participants with available data for specifies category.|||percentage of participants|||Number
2629420|NCT01866150|Secondary|Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and either ESR or C Reactive Protein (CRP) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.|Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with post-baseline available data. Here, 'n' signifies number of participants with available data at specified category.|||units on a scale||Standard Error|Mean
2629448|NCT01865487|Primary|Number and Percentage of Unsolicited and Solicited Adverse Events Recorded Post Day 0 Vaccination.|Evaluation of unsolicited and solicited AEs was performed through 28 days after each study vaccination. Serious AEs were collected throughout the entire study period (i.e., 292 days). Evaluation of the safety profile of AERAS-456 was performed using data from all subjects who received at least one dose.|Up to 10 months|Safety analysis set|||Participants|||Number
2654579|NCT01634269|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||24 months||||mmHg||Standard Deviation|Mean
2629421|NCT01866150|Secondary|Percentage of Participants Who Achieved Low Disease Activity (LDA) (DAS28-ESR <3.2) at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the ESR for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6. LDA was defined as a DAS28 score <3.2.|Months 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for DAS28-ESR. Here, 'n' signifies number of participants with available data for specified category.|||percentage of participants|||Number
2629422|NCT01866150|Secondary|Percentage of Participants Who Achieved DAS28-ESR Remission (DAS28-ESR <2.6) at 3 Months and at the Last Visit After Initiation of First-Line Biologic Treatment|The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the ESR for a total possible score of 0 to approximately 10. DAS28 = (0.56 * √ of TJC) + (0.28 * √ of SJC) + (0.70 * ln ESR in mm/h) + (0.014 * participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score < 2.6.|Month 3 and the last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for DAS28-ESR. Here, 'n' signifies number of participants with available data for specified category.|||percentage of participants|||Number
2629423|NCT01866150|Primary|Percentage of Participants Who Achieved Disease Activity Score Based on 28-joint Count (DAS-28) and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at 6 Months (DAS28<2.6)|The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. DAS28 equals (=) (0.56 multiplied by [*] the square root [√] of TJC) plus (+) (0.28 * √ of SJC) + (0.70 * the natural logarithm [ln] ESR in millimeters per hour [mm/h]) + (0.014 * participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score <2.6.|Month 6|Ten participants from all participants entered analysis set who could not be categorized as under biologic monotherapy or biologic combination therapy were excluded from analysis. Number of participants analyzed=participants with available data for DAS28-ESR at Month 6.|||percentage of participants|||Number
2629424|NCT01866098|Secondary|Changes in LDL From Baseline|Low-density lipoprotein (HDL) will be collected over the course of participation and changes will be evaluated at study endpoint.|Week 52|Analysis population consists of participants who were randomized, received at least 1 dose of the trial compound (naltrexone or placebo), and had at least 1 assessment after baseline.|||mg/dL||Standard Error|Least Squares Mean
2629425|NCT01866098|Secondary|Changes in HDL From Baseline|High-density lipoprotein (HDL) will be collected over the course of participation and changes will be evaluated at study endpoint.|Week 52|Analysis population consists of participants who were randomized, received at least 1 dose of the trial compound (naltrexone or placebo), and had at least 1 assessment after baseline.|||mg/dL||Standard Error|Least Squares Mean
2629426|NCT01866098|Secondary|Changes in Total Cholesterol From Baseline|Total Cholesterol will be collected over the course of participation and changes will be evaluated at study endpoint.|Week 52|Analysis population consists of participants who were randomized, received at least 1 dose of the trial compound (naltrexone or placebo), and had at least 1 assessment after baseline.|||mg/dL||Standard Error|Least Squares Mean
2629427|NCT01866098|Secondary|Changes in Insulin From Baseline|Insulin will be collected over the course of participation and changes will be evaluated at study endpoint.|Week 52|Analysis population consists of participants who were randomized, received at least 1 dose of the trial compound (naltrexone or placebo), and had at least 1 assessment after baseline.|||mg/dL||Standard Error|Least Squares Mean
2629428|NCT01866098|Secondary|Changes in Glycosylated Hemoglobin (HbA1c) From Baseline|Glycosylated hemoglobin (HbA1c) will be collected over the course of participation and changes will be evaluated at study endpoint.|Week 52|Analysis population consists of participants who were randomized, received at least 1 dose of the trial compound (naltrexone or placebo), and had at least 1 assessment after baseline.|||mg/dL||Standard Error|Least Squares Mean
2629429|NCT01866098|Secondary|Changes in Fasting Glucose From Baseline|Fasting glucose will be collected over the course of participation and changes will be evaluated at study endpoint.|Week 52|Analysis population consists of participants who were randomized, received at least 1 dose of the trial compound (naltrexone or placebo), and had at least 1 assessment after baseline.|||mg/dL||Standard Error|Least Squares Mean
2629430|NCT01866098|Primary|Percent of Subjects Who Lost More Than 5% of Body Weight From Baseline|Body Mass Index will be calculated at each assessment and change over time will be assessed at endpoint.|52 weeks|Analysis population consists of participants who were randomized, received at least 1 dose of the trial compound (naltrexone or placebo), and had at least 1 assessment after baseline.|||Participants|||Count of Participants
2629431|NCT01866098|Primary|Change in Weight From Baseline|Weight (kilograms; kg) will be measured at each assessment and change in weight will be determined at study endpoint.|52 weeks|Analysis population consists of participants who were randomized, received at least 1 dose of the trial compound (naltrexone or placebo), and had at least 1 assessment after baseline.|||kg||Standard Error|Least Squares Mean
2629432|NCT01865812|Primary|Absolute Change From Baseline in High-density Lipoprotein (HDL) Particle Concentration||Baseline, Week 8||||umol/L||95% Confidence Interval|Least Squares Mean
2629433|NCT01865812|Primary|Absolute Change From Baseline in High-density Lipoprotein (HDL) Particle Size||Baseline, Week 8||||nm||95% Confidence Interval|Least Squares Mean
2629434|NCT01865812|Primary|Absolute Change From Baseline in High-density Lipoprotein (HDL) Cholesterol Concentration||Baseline, Week 8||||mmol/L||95% Confidence Interval|Least Squares Mean
2629435|NCT01865747|Secondary|Objective Response Rate (ORR)|Objective Response Rate (ORR) is the number of participants with a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. ORR was assessed by the Independent Radiology Committee (IRC) per RECIST 1.1 which was confirmed by a subsequent visit >= 28 days later, and was analyzed in the Intent to Treat (ITT) population at the time of the primary analysis of Progression Free Survival (PFS). The data cutoff date was 22 May 2015.|ORR was assessed at 8 weeks post-randomization, every 8 weeks for 12 months, and every 12 weeks until date of disease progression or death, up to May 2015 (approximately 21 months)|The analysis of ORR was performed in the ITT population (all randomized: 330 cabozantinib, 328 everolimus) based upon response determined by Independent Radiology Committee (IRC) per RECIST 1.1.|||percentage of participants|||Number
2629436|NCT01865747|Secondary|Overall Survival (OS)|Overall Survival (OS) is defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS was calculated using Kaplan-Meier estimates. Interim analyses for OS occurred after 320 deaths (78% of the total OS events needed for final analysis).|OS was measured from the time of randomization until 320 deaths, approximately 28 months|The Intent to Treat (ITT) population was used and included 658 randomized subjects (330 cabozantinib, 328 everolimus) in the second interim analysis with a cutoff date of 31 December 2015.|||months||95% Confidence Interval|Number
2629437|NCT01865747|Primary|Progression-free Survival (PFS)|The primary analysis of PFS is the time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria) or death due to any cause, whichever occurred first. A Kaplan-Meier analysis was performed to estimate the median duration.|PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause as determined by the Independent Radiology Committee (IRC) per RECIST 1.1, assessed for up to 17 months.|The pre-specified primary analysis of PFS was based on the first 375 randomized subjects (187 cabozantinib and 188 everolimus).|||months||95% Confidence Interval|Number
2629438|NCT01865708|Secondary|Urine Analysis|"An ethanol lock, utilizing 74% ethanol, will begin within 24 hours of catheter placement. The lock will be done every 24 hours for 1 hour, for a total of 3 days.~A baseline urinalysis will be obtained prior to the first instillation of ethanol, looking for hematuria.~A urinalysis will be obtained approximately 1 hour after the lock is released. Data shown is the mean increase in red blood cells per high powered field after ethanol instillation averaged across all post-ethanol lock days and all patients compared to the mean baseline red blood cells per high powered field in urinalysis prior to any ethanol lock."|Data shown is the mean increase in red blood cells per high powered field after ethanol instillation averaged across all post-EL days and all patients compared to the mean baseline red blood cells per high powered field in urinalysis prior to any EL.|Change in detectable red blood cells per high powered field in urinalysis. Data shown is the mean increase in red blood cells per high powered field after ethanol instillation averaged across all post-EL days and all patients compared to the mean baseline red blood cells per high powered field in urinalysis prior to any EL.|||red blood cells per high powered field||Standard Deviation|Mean
2629439|NCT01865708|Primary|Blood Alcohol Level|An ethanol lock, utilizing 74% ethanol, will begin within 24 hours of catheter placement. The lock will be done every 24 hours for 1 hour. Blood alcohol levels will be obtained every day, approximately 1 hour after ethanol lock release, for 3 days: at baseline, 1 day post catheter placement, 2 days post catheter placement, and 3 days post catheter placement. Number of participants with Blood Alcohol Levels exceeding 10 mg/100 ml on any study day was analyzed.|up to 3 days|Number of patients with detectable blood alcohol level, defined as >= 10 mg/dL.|||Participants|||Count of Participants
2629440|NCT01865552|Secondary|Time to Cmax (Tmax)|pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose|0 to 480 hours post-dose|Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.|||h||Standard Deviation|Mean
2629441|NCT01865552|Secondary|Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)|pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose|0 to 480 hours post-dose|Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.|||µg·h/mL||Standard Deviation|Mean
2629442|NCT01865552|Primary|Maximum Serum Concentration (Cmax)|pre-dose (0 h) and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose.|0 to 480 hours post-dose|Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.|||μg/mL||Standard Deviation|Mean
2629443|NCT01865552|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)|pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose|0 to 480 hours post-dose|Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.|||µg·h/mL||Standard Deviation|Mean
2629444|NCT01865487|Secondary|Evaluate Kinetics of QuantiFERON®-TB Gold Test (QFT) Responses in LTBI-negative Participants|"QFT results were summarized using subject count (percentage) for qualitative results.~Number of participants QFT-positive at any time point."|Up to Study Day 292|Conversion of LTBI-negative at baseline to LTBI-positive due to H56:IC31 expression of ESAT-6 (antigen in QFT assay).|||Participants|||Count of Participants
2629445|NCT01865487|Secondary|Evaluate Immunogenicity of Multiple Dosage Levels and Dosing Regimens of H56:IC31 - IFN-gamma ELISpot|DMSO-subtracted Antigen-specific IFN-gamma ELISpot Response (SFU - Background/10^6 PBMC) Change from Baseline LTBI Status at Baseline: Total Stimulation Antigen: Total|Day 292|Immunogenicity analysis set|||Number of spots per well||Standard Deviation|Mean
2629446|NCT01865487|Secondary|Evaluate Immunogenicity of Multiple Dosage Levels and Dosing Regimens of H56:IC31 - CD4+ ICS (LTBI-positive)|"Percent Antigen-specific T Cell DMSO-subtracted Cytokine Response Change from Baseline.~13-color ICS assay using PBMCs. T Cell: CD4+ Stimulation Antigen: Total Cytokine: Any"|Day 292|Immunogenicity analysis set: LTBI-positive at baseline|||Percentage of change from baseline||Standard Deviation|Mean
2629447|NCT01865487|Secondary|Evaluate Immunogenicity of Multiple Dosage Levels and Dosing Regimens of H56:IC31 - CD4+ ICS (LTBI-negative)|LTBI: Latent TB Infection QFT: QuantiFERON-TB Gold Plus (QFT-Plus) is an in vitro diagnostic aid for detection of Mycobacterium tuberculosis infection Percent Antigen-specific T Cell DMSO-subtracted Cytokine Response Change from Baseline 13-color ICS assay using PBMCs T Cell: CD4+ Stimulation Antigen: Total Cytokine: Any|Day 292|Immunogenicity analysis set: LTBI-negative at baseline|||Percentage of change from baseline||Standard Deviation|Mean
2629449|NCT01865448|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Number of Participants with Adverse Events as a Measure of Safety and Tolerability of standardized weight-loss programme (PronoKal® Method)and Safety and Tolerability of DHA Supplements|6 months||||participants|||Number
2629450|NCT01865448|Secondary|Proresolution Index|Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators|2 months||||ratio||Standard Deviation|Mean
2629451|NCT01865448|Secondary|Sum of Proresolving Mediators at 2 Months|sum of proresolving mediators at 2 months|2 months||||pg/ml||Standard Deviation|Mean
2629452|NCT01865448|Secondary|Sum of Proinflammatory Mediators at 2 Months|sum of proinflammatory mediators at 2 months|2 months||||pg/ml||Standard Deviation|Mean
2629453|NCT01865448|Secondary|7RMAR1 at 6 Months|Level of 7RMAR1 at 6 months|6 months||||pg/ml||Standard Deviation|Mean
2629454|NCT01865448|Secondary|7RMAR1 at 2 Months|Level of 7RMAR1 at 2 months|2 months||||pg/ml||Standard Deviation|Mean
2629455|NCT01865448|Secondary|7SMAR1 at 6 Months|Level of 7SMAR1 at 6 months|6 months||||pg/ml||Standard Deviation|Mean
2629456|NCT01865448|Secondary|7SMAR1 at 2 Months|Level of 7SMAR1 at 2 months|2 months||||pg/ml||Standard Deviation|Mean
2629457|NCT01865448|Secondary|PD1 at 6 Months|Level of PD1 at 6 months|6 months||||pg/ml||Standard Deviation|Mean
2629458|NCT01865448|Secondary|PD1 at 2 Months|Level of PD1 at 2 months|2 months||||pg/ml||Standard Deviation|Mean
2629459|NCT01865448|Secondary|RVD2 at 6 Months|Level of RVD2 at 6 months|6 months||||pg/ml||Standard Deviation|Mean
2629460|NCT01865448|Secondary|RVD2 at 2 Months|Level of RVD2 at 2 motnhs|2 months||||pg/ml||Standard Deviation|Mean
2629461|NCT01865448|Secondary|4-HDOHE at 6 Months|Level of 4-HDOHE at 6 months|6 months||||pg/ml||Standard Deviation|Mean
2629462|NCT01865448|Secondary|4-HDOHE at 2 Months|Level of 4-HDOHE at 2 months|2 months||||pg/ml||Standard Deviation|Mean
2629463|NCT01865448|Secondary|7-HDOHE at 6 Months|Level of 7-HDOHE at 6 months|6 months||||pg/ml||Standard Deviation|Mean
2629464|NCT01865448|Secondary|7-HDOHE at 2 Months|Level of 7-HDOHE at 2 months|2 months||||pg/ml||Standard Deviation|Mean
2629465|NCT01865448|Secondary|14-HDOHE at 6 Months|Level of 14-HDOHE at 6 months|6 months||||pg/ml||Standard Deviation|Mean
2629466|NCT01865448|Secondary|14-HDOHE at 2 Months|Level of 14-HDOHE at 2 months|2 months||||pg/ml||Standard Deviation|Mean
2629467|NCT01865448|Secondary|17-HDOHE at 6 Months|Level of 17-HDOHE at 6 months|6 months||||pg/ml||Standard Deviation|Mean
2629468|NCT01865448|Secondary|17-HDOHE at 2 Months|Level of 17-HDOHE at 2 months|2 months||||pg/ml||Standard Deviation|Mean
2629469|NCT01865448|Secondary|LTB4 at 6 Months|Level of LTB4 at 6 months|6 months||||pg/ml||Standard Deviation|Mean
2629470|NCT01865448|Secondary|LTB4 at 2 Months|Level of LTB4 at 2 months|2 months||||pg/ml||Standard Deviation|Mean
2629471|NCT01865448|Secondary|PGE2 at 6 Months|Level of PGE2 at 6 months|6 months||||pg/ml||Standard Deviation|Mean
2629472|NCT01865448|Secondary|PGE2 at 2 Months|Level of PGE2 at 2 months|2 months||||pg/ml||Standard Deviation|Mean
2629473|NCT01865448|Secondary|TXB2 at 6 Months|Level of TXB2 at 6 months|6 months||||pg/ml||Standard Deviation|Mean
2629474|NCT01865448|Secondary|TXB2 at 2 Months|Level of TXB2 at 2 months|2 months||||pg/ml||Standard Deviation|Mean
2629475|NCT01865448|Secondary|5-HETE at 6 Months|Level of 5-HETE at 6 months|6 months||||pg/ml||Standard Deviation|Mean
2629476|NCT01865448|Secondary|5-HETE at 2 Months|Level of 5-HETE at 2 months|2 months||||pg/ml||Standard Deviation|Mean
2629477|NCT01865448|Secondary|8-HETE at 6 Months|Level of 8-HETE at 6 months|6 months||||pg/ml||Standard Deviation|Mean
2629478|NCT01865448|Secondary|8-HETE at 2 Months|Level of 8-HETE at 2 months|2 months||||pg/ml||Standard Deviation|Mean
2629479|NCT01865448|Secondary|12-HETE at 6 Months|Level of 12-HETE at 6 months|6 months||||pg/ml||Standard Deviation|Mean
2629480|NCT01865448|Secondary|12-HETE at 2 Months|Level 12-HETE at 2 months|2 month||||pg/ml||Standard Deviation|Mean
2629481|NCT01865448|Secondary|15-HETE at 6 Months|Level of 15-HETE at 6 months|6 months||||pg/ml||Standard Deviation|Mean
2629482|NCT01865448|Secondary|15-HETE at 2 Months|Level of 15-HETE at 2 months|2 months||||pg/ml||Standard Deviation|Mean
2629483|NCT01865448|Secondary|Leptin at 6 Months|Level of Leptin at 6 months|6 months||||ng/ml||Standard Deviation|Mean
2629484|NCT01865448|Secondary|Leptin at 2 Months|Level of Leptin at 2 months|2 months||||ng/ml||Standard Deviation|Mean
2629485|NCT01865448|Secondary|Resistin at 6 Months|Level of Resistin at 6 months|6 months||||ng/ml||Standard Deviation|Mean
2629486|NCT01865448|Secondary|Resistin at 2 Months|Level of Resistin at 2 months|2 months||||ng/ml||Standard Deviation|Mean
2629487|NCT01865448|Secondary|Interleukin-6 at 6 Months|Level of Interleukin-6 at 6 months|6 months||||ng/ml||Standard Deviation|Mean
2629488|NCT01865448|Secondary|Interleukin-6 at 2 Months|Level of Interleukin-6 at 2 months|2 months||||ng/ml||Standard Deviation|Mean
2629489|NCT01865448|Secondary|Tnf Alpha at 6 Months|Level of Tnf alpha at 6 months|6 months||||ng/ml||Standard Deviation|Mean
2629490|NCT01865448|Secondary|Tnf Alpha at 2 Months|Level of Tnf alpha at 2 months|2 months||||ng/ml||Standard Deviation|Mean
2629491|NCT01865448|Secondary|Adiponectin at 6 Months|Level of Adiponectin at 6 months|6 months||||ng/ml||Standard Deviation|Mean
2629492|NCT01865448|Secondary|Adiponectin at 2 Months|Level of Adiponectin at 2 months|2 months||||ng/ml||Standard Deviation|Mean
2629493|NCT01865448|Secondary|C-reactive Protein (CRP) at 6 Months|Level of c.reactive protein (CRP) at 6 months|6 months||||mg/dl||Standard Deviation|Mean
2629494|NCT01865448|Secondary|C-reactive Protein (CRP) at 2 Months|Level of c-reactive protein (CRP) at 2 months|2 months||||mg/dl||Standard Deviation|Mean
2629495|NCT01865448|Primary|Sum of Proinflammatory Mediators at 6 Months|Sum of proinflammatory mediators at 6 months|6 months||||pg/ml||Standard Deviation|Mean
2629496|NCT01865448|Primary|Sum of Proresolving Mediators at 6 Months|Sum of proresolving mediators at 6 months|6 months||||pg/ml||Standard Deviation|Mean
2629497|NCT01865448|Secondary|Waist Circumference at 6 Months|Waist circumference at 6 Months (end of the monitoring period)|6 months||||cm||Standard Deviation|Mean
2629501|NCT01865084|Secondary|Pharmacokinetics (PK): Apparent Clearance (CL/F) of Tadalafil|The data reported are population estimate and inter-patient variability.|Weeks 4, 12, 24 and 36: -1 Hour up to 24 Hours Postdose|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2629502|NCT01865084|Secondary|Change From Baseline in Pediatric Outcomes Data Collection Instrument (PODCI) Scores|"PODCI includes a Global Functioning Scale and 5 core scales:Upper Extremity and Physical Function,Transfer/Basic Mobility, Sports/Physical Functioning, Pain/Comfort,and Happiness.The Global Functioning Scale is the mean of the mean scores from 4 of the 5 core scales (all except the happiness core scale).The following PODCI scores were prespecified in the protocol for analysis: Global Functioning, Upper Extremity and Physical Function,Transfer/Basic Mobility, and Sports/Physical Functioning. The Global Functioning Scale and each of the core scales were standardized so that a score of 0 represents a poor outcome/worse health, while 100 is the best possible outcome/best health (i.e., complete range of each score is 0 to 100, with higher scores representing better functioning). The LS mean (LSM) change from baseline,standard error was derived using MMRM with factors for pooled country, treatment, visit, treatment-by-visit interaction and baseline PODC scale as covariate."|Baseline, Week 48|All randomized participants who received at least one dose of study drug who had a baseline and at least one post-baseline measurement. The reason the number of participants analyzed is significantly less than the total number of randomized participants is because PODCI was administered only in English.|||Units on a scale||Standard Error|Least Squares Mean
2629503|NCT01865084|Secondary|Time to Persistent 10% Worsening in Timed Function Tests (TFT)|"Time on study until the TFT becomes 10% worse than the baseline TFT and continues at that level or lower until the end of study. The time to persistent 10% worsening is the observed time after baseline until the first observed timepoint where their time used for the TFTs is >110% of the baseline time and all the time values observed afterward are also >110% of baseline. If the participant discontinues prior to experiencing persistent worsening, this outcome for the participant is censored at the date of discontinuation of the double-blind period.~Only participants with complete evaluable data were analyzed. Complete evaluable data was defined as having baseline measurement, complete dates at evaluable visits and a post-baseline measurement at each evaluable visit."|Baseline through Week 48|All randomized participants who received at least 1 dose of study drug who had complete evaluable data.Censored participants:Rise from Floor;placebo(pl)=40,0.3 mg/kg=39,0.6 mg/kg=43;Stair Climb;pl=55,0.3 mg/kg=45,0.6 mg/kg=52;10 Meter Walk/Run pl=61,0.3 mg/kg=65,0.6 mg/kg=58,Stair Descend;pl=63,0.3 mg/kg=60,0.6 mg/kg=59.|||Days||95% Confidence Interval|Median
2629504|NCT01865084|Secondary|Time to Persistent 10% Worsening in 6MWD|Time on study until the 6MWD becomes 10% less than the baseline 6MWD and continues at that level or lower until the end of study.|Baseline through Week 48|All randomized participants who received at least one dose of study drug who had complete evaluable data. Complete evaluable data was defined as having baseline measurement, complete dates at evaluable visits and a post-baseline measurement at each evaluable visit. Censored participants: placebo=71, 0.3 mg/kg=63, 0.6 mg/kg=61.|||Days||95% Confidence Interval|Median
2629505|NCT01865084|Secondary|Change From Baseline in Timed Function Tests in Seconds|Timed function tests included time it took to rise from floor, walk 10 meters, ascend 4 stairs, and descend 4 stairs.The lower the time in seconds taken, the better the performance. The LS mean change from baseline, standard error, was derived using mixed model repeated measures methodology (MMRM) with factors for pooled country, treatment, visit, treatment-by-visit interaction and Day 1 value as baseline covariate.|Baseline, Week 48|All randomized participants who received at least one dose of study drug who had a baseline and at least one post-baseline measurement.|||Seconds||Standard Error|Least Squares Mean
2629506|NCT01865084|Secondary|Change From Baseline in the North Star Ambulatory Assessment (NSAA) Global Score|The NSAA is a functional scale specifically designed for ambulant boys with DMD that can provide additional information on motor functions important in maintaining normal ambulation and other activities important to everyday life. The NSAA is a 17-item evaluation of standing, ability to transition from lying to sitting, sitting to standing, and other mobility assessments. Each of the 17 items is evaluated on an ordinal scale of 0, 1, or 2, with higher scores reflecting better performance on the assessment, for a total maximum score of 34. This score was transformed to a 0 to 100 scale for the key analysis (referred to as linearized), with higher transformed scores reflecting better performance.The LS mean (LSM) change from baseline standard error was derived using mixed model repeated measures methodology (MMRM) with factors for pooled country, treatment, visit, treatment-by-visit interaction and Day 1 value as baseline covariate.|Baseline, Week 48|All randomized participants who received at least one dose of study drug who had a baseline and at least one post-baseline measurement.|||Units on a scale||Standard Error|Least Squares Mean
2629507|NCT01865084|Primary|Change From Baseline in Six Minute Walk Distance (6MWD) in Meters|"6MWD measured the distance in meters a participant was able to walk in 6 minutes. The study used 6MWD procedure modified specifically for use in boys with Duchenne muscular dystrophy (DMD), including standardized verbal encouragement at specific intervals to maintain attention to the test, and use of a safety chaser to walk behind the participant during testing (McDonald et al., 2010a). The LS mean (LSM) change from baseline, standard error was derived using mixed model repeated measures (MMRM) methodology with factors for pooled country, treatment, visit, treatment-by-visit interaction and baseline 6MWD as a covariate."|Baseline, Week 48|All randomized participants who received at least one dose of study drug who had a baseline and at least one post-baseline measurement.|||Meters||Standard Error|Least Squares Mean
2629508|NCT01864538|Primary|Overall Survival||1 year||||Participants|||Count of Participants
2629518|NCT01864174|Secondary|Mean Change in Fasting Plasma Glucose (FPG)|The mean change in fasting plasma glucose (FPG) from baseline to Week 24 in the double-blind treatment period was assessed. The lack of glycemic control criteria for initiation of rescue medication during Week 12 to Week 24 was having a FPG > 200 mg/dL (11.1 mmol/L). mg/dL = milligrams per deciliter; mmol/L = millimole per Liter|Baseline and Week 24|Randomized participants who took at least one dose of double-blind study medication in the treatment group to which they were randomized with non-missing baseline and Week 24 values and who were not excluded due to non-compliance.|||mg/dL||Standard Error|Mean
2629683|NCT01860651|Secondary|Number of Weeks Between Treatment|Date of IFX infusions were prospectively registered from both the eHealth and the control groups.|Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years||||weeks||Standard Deviation|Mean
2629509|NCT01864525|Secondary|Auditory-perceptual Tremor Severity Ratings|Three experienced listeners independently rated each participant's voice from paired sample recordings comparing the baseline to post-test samples in randomized order for each condition. Sustained vowel and sentence-level recordings were rated, with decoded samples later analyzed for 1=better for post-test compared to baseline, 0= no difference between post-test and baseline. Maximum score for each participant was 3 (post-test was better for each of three raters). The range of possible scores was the sum of each of three raters' scores (0 to 3), with 0 indicating no difference between baseline and post-test voice tremor severity rating, and 3 indicating better voice (less tremor severity) at post-testing compared to pre-testing. Mean post-test values for task were compared for the octanoic acid and placebo conditions, and all raters were blind to which sample was a baseline versus a post-test recording, and which samples were associated with the [placebo or octanoic acid conditions.|Measured at baseline visits (1 & 2) and after 3 weeks of placebo or octanoic acid on post-test visits (1 & 2).||||units on a scale||Standard Deviation|Mean
2629510|NCT01864525|Primary|Magnitude of Acoustic Amplitude Tremor and Magnitude of Acoustic Frequency Tremor|Voice recordings were used to measure the degree of tremor in the voice. Mean post-test values for each acoustic measure were compared after the octanoic acid and placebo conditions, with and without consideration of baseline values. Mean values represent the average of two testing days. Degree of amplitude tremor shows the extent of amplitude variation as a percent of the mean signal amplitude, with lower numbers indicating less amplitude tremor. Baseline values for magnitude of amplitude tremor across all participants and conditions ranged from 4.06 to 27.09, and post-test values ranged from 1.94 to 26.02. Degree of frequency tremor shows the extent of fundamental frequency variation as a percent of the mean signal frequency, with lower numbers indicating less frequency tremor. Baseline values for magnitude of frequency tremor across all participants and conditions ranged from 1.21 to 15.31, and post-test values ranged from 0.60 to 13.86.|Measured at baseline visits (1 & 2) and after 3 weeks of placebo or octanoic acid on post-test visits (1 & 2)||||percentage of voice signal with tremor||Standard Deviation|Mean
2629511|NCT01864434|Primary|Kinematics - Ramp Down Activity|Lateral Anterior Posterior (LAP) [during 3 moments - 0-33%, 33-66% and 66-100%] and Medial Anterior Posterior (MAP) [during 3 moments - 0-33%, 33-66% and 66-100%] translations, and Axial Rotation (AR) [during 3 moments - 0-33%, 33-66% and 66-100%] of medial femoral condyles during ramp down activity|3 months post-operative||||mm||Standard Deviation|Mean
2629512|NCT01864434|Primary|Kinematics - Ramp up Activity|Lateral Anterior Posterior (LAP) [during 3 moments - 0-33%, 33-66% and 66-100%] and Medial Anterior Posterior (MAP) [during 3 moments - 0-33%, 33-66% and 66-100%] translations, and Axial Rotation (AR) [during 3 moments - 0-33%, 33-66% and 66-100%] of medial femoral condyles during ramp up activity|3 months post-operative||||mm||Standard Deviation|Mean
2629513|NCT01864434|Primary|Kinematics - Deep Knee Bend Activity|Lateral Anterior Posterior (LAP) and Medial Anterior Posterior (MAP) translations, and Axial Rotation (AR) and maximum flexion of medial femoral condyles during deep knee bend (DKB) activity|3 months post-operative||||mm||Standard Deviation|Mean
2629514|NCT01864200|Primary|Patient Specific Functional Scale Score|"Patient Specific Functional Scale (PSFS) at 14 day follow-up This is a three-item instrument, administered verbally, that is used to evaluate whether a health condition impacts a patient's ability to perform activities that are important to him/her. On the initial assessment, the patient is asked to identify up to three important activities that you are unable to do or are having difficulty with as a result of your (snakebite). The patient then provides a rating for each item, on an 11-point ordinal scale ranging from 0 (unable to perform activity) to 10 (able to perform activity at the same level as before the injury or problem). During reassessments, the subject is prompted to re-rate the same three activities. The average of up to 3 specific activity scores was recorded, and the range of possible scores is 0 - 10. Higher scores indicate less impairment."|at 14 day follow-up||||units on a scale||Standard Error|Mean
2629515|NCT01864174|Primary|Number of Participants With Death, Serious Adverse Events (SAEs), SAEs Related to Study Therapy, SAEs Leading to Discontinuation, Adverse Events (AEs) Related to Study Therapy, and AEs Leading to Discontinuation|SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. All listed events are treatment emergent, which is defined as nonserious and serious AEs with an onset from Day 1 of the double-blind treatment up to and including 4 days and 30 days respectively, after the last dose date of double-blind study. randomized.|Date of first dose (Day 1) up to 30 post last dose of study drug (approx. 28 weeks)|Treated participants; All participants who took at least one dose of double-blind study medication in the treatment group they were randomized to unless participants had never received the double-blind study medication they were randomized. Those participants were included in the treatment group based on the first treatment received.|||participants|||Number
2629516|NCT01864174|Secondary|Percent of Participants With HbA1c < 7%|Percent of participants achieving a therapeutic glycemic response (defined as HbA1c < 7.0%) at Week 24 in the double-blind treatment period.|Week 24|Randomized participants who took at least one dose of double-blind study medication in the treatment group to which they were randomized with non-missing baseline and Week 24 values who were not excluded due to non-compliance.|||percent of participants||95% Confidence Interval|Number
2629517|NCT01864174|Secondary|Mean Change in Mean Daily Glucose (MDG)|The mean change in Mean Daily Glucose (MDG) from baseline to Week 24 in the double-blind treatment period was assessed. Prior to the Day 1 visit (between Week -1 and Day 1) and in the week before the Week 24/Study Termination and Rescue or Early Treatment Termination visit, participants performed 7-point finger stick blood glucose monitoring (before and 2 hours after 3 meals per day, and at bedtime) for 3 consecutive days in order to determine their MDG.|Baseline and Week 24|Randomized participants who took at least one dose of double-blind study medication in the treatment group to which they were randomized with non-missing baseline and Week 24 last observation carried forward (LOCF) results who were not excluded due to non-compliance.|||mg/dL||Standard Error|Mean
2629684|NCT01860651|Secondary|Contact to the Hospital|Need for outpatient visits|Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years||||visits||Inter-Quartile Range|Median
2629519|NCT01864174|Primary|Adjusted Mean Change From Baseline in HbA1c|Mean change in glycated hemoglobin (HbA1c) from baseline to Week 24 in the double-blind treatment period.|Baseline and Week 24|Randomized participants who took at least one dose of double-blind study medication in the treatment group to which they were randomized with non-missing baseline and Week 24 values who were not excluded due to non-compliance.|||percent||Standard Error|Mean
2629520|NCT01864148|Secondary|Pharmacokinetics: BIIB033 Plasma Concentrations up to Week 84||Up to 84 weeks|PK Population: participants who received at least 1 dose of BIIB033 and had at least 1 serum concentration data point on record.|||µg/mL||Standard Deviation|Mean
2629521|NCT01864148|Secondary|Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) and Discontinuations Due to AEs|An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the participant at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above.|Up to 84 weeks|Safety Population: all participants who received at least 1 dose of study treatment.|||participants|||Number
2629522|NCT01864148|Secondary|Proportion of Participants Confirmed as Worsening Responders for Primary Multicomponent Endpoint|Estimated proportion of participants experiencing confirmed clinical worsening in 1 or more components of the multicomponent endpoint (EDSS, T25FW, 9HPT, or PASAT-3) over 72 weeks, defined as: a ≥1.0 point increase in EDSS from a baseline score of ≤5.5 or a ≥0.5 point increase from a baseline score equal to 6.0 (increase sustained for 3 months or greater); a ≥15%worsening from baseline in time to complete T25FW test (worsening sustained for 3 months or greater), where the time is the average of 2 trials at the same visit; a ≥15% worsening from baseline in time to complete 9HPT by either hand (worsening sustained for 3 months or greater for the same hand), where the time is the average of 2 trials for each hand at the same visit; a ≥15% worsening from baseline in PASAT-3 score (worsening sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for MS type, region and baseline component assessments.|72 weeks|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and included in the efficacy analysis (6 participants were excluded due to study site Good Clinical Practice deviation).|||proportion of participants|||Number
2629523|NCT01864148|Primary|Proportion of Participants Confirmed as Improvement Responders for Primary Multicomponent Endpoint|Estimated proportion of participants experiencing confirmed improvement in any 1 or more of the following components: a ≥1 point decrease in the Expanded Disability Status Scale (EDSS) score from a baseline score of <=6.0 (decrease sustained for ≥3 months); a ≥15% improvement from baseline in time to complete 9-Hole Peg Test (9HPT) by either hand (improvement sustained for ≥3 months for the same hand), where the time is the average time of 2 trials per hand at the same visit; a ≥15% improvement from baseline in time to complete Timed 25-Foot Walk (T25FW) test (improvement sustained for ≥3 months), where the time is the average time of 2 trials at the same visit; or a ≥15% improvement from baseline 3-Second Paced Auditory Serial Addition Test (PASAT-3) score (improvement sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for multiple sclerosis (MS) type, region and baseline component assessments.|72 weeks|Intent-to-treat population: all randomized participants who received at least 1 dose of study treatment and included in the efficacy analysis (6 participants were excluded due to study site Good Clinical Practice deviation).|||proportion of participants|||Number
2629524|NCT01864005|Secondary|the Percentage Inhibition of the P2Y12 Receptor||at 6 weeks after first dose of study drug|PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.|||Percentage Inhibition||Standard Deviation|Mean
2629525|NCT01864005|Secondary|the Percentage Inhibition of the P2Y12 Receptor||at 24 hours after first dose of study drug|PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.|||Percentage Inhibition||Standard Deviation|Mean
2629526|NCT01864005|Secondary|the Percentage Inhibition of the P2Y12 Receptor||at 8 hours after first dose of study drug|PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.|||Percentage Inhibition||Standard Deviation|Mean
2629527|NCT01864005|Secondary|the Percentage Inhibition of the P2Y12 Receptor||at 0.5 hour after first dose of study drug|PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.|||Percentage Inhibition||Standard Deviation|Mean
2629528|NCT01864005|Primary|the Percentage Inhibition of the P2Y12 Receptor|Note: the primary endpoint was changed per the statistical analysis plan prior database lock.|at 2 hours after first dose of study drug|FAS (full analysis set). Three randomized patients were excluded from FAS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, and 4) use of prohibited medications.|||Percentage Inhibition||Standard Deviation|Mean
2629529|NCT01863953|Secondary|Average Eye Mean Diurnal IOP|IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12.|Day 14, Day 28, Day 42|Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment|||mmHg||Standard Deviation|Mean
2629530|NCT01863953|Secondary|Change From Baseline in Average Eye Mean Diurnal IOP|IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Day 14, Day 28|Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment|||mmHg||Standard Deviation|Mean
2629531|NCT01863953|Primary|Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Day 42|Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2629532|NCT01863771|Secondary|Number of Participants With Mucosal Healing at Both Maintenance-Week 30 and Week 54|Mucosal healing is defined as an endoscopy subscore of 0 or 1, where 0 indicates normal or inactive disease and 1 indicates mild disease (erythema, decreased vascular pattern, mild friability). Endoscopy subscore is one of the 4 subscores of the Mayo score.|Weeks 30 and 54|Efficacy full analysis set for maintenance phase included all participants who responded to golimumab induction treatment and subsequently randomized at Week 0 in maintenance phase. Data for this outcome was not planned to be analyzed for participants who had not responded to golimumab induction dosing, as pre-specified in protocol.|||participants|||Number
2629533|NCT01863771|Secondary|Number of Participants Who Achieved Clinical Remission at Both Maintenance-Week 30 and Week 54|Clinical remission (as measured by the Mayo score) was defined as a Mayo score of less than or equal to (<=) 2 points, with no individual sub-score greater than (>) 1.|Weeks 30 and 54|Efficacy full analysis set for maintenance phase included all participants who responded to golimumab induction treatment and subsequently randomized at Week 0 in maintenance phase. Data for this outcome was not planned to be analyzed for participants who had not responded to golimumab induction dosing, as pre-specified in protocol.|||participants|||Number
2629534|NCT01863771|Primary|Number of Participants Who Achieved Clinical Response Through Maintenance-Week 54 Measured Using the Mayo Score|Clinical response was defined as a decrease from Induction-Week 0 in the Mayo score by greater than or equal to (>=) 30 percent and >=3 points, with a decrease in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1. The Mayo score is the primary tool for assessing ulcerative colitis activity. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, findings of endoscopy, and physician's global assessment) which range from 0 to 3. The Mayo score is calculated as the sum of these 4 subscores and can range between 0 and 12. A score of 3 to 5 points indicates mildly active disease; a score of 6 to 10 indicates moderately active disease; and a score of 11 to 12 indicates severe disease.|Up to Week 54|Efficacy full analysis set for maintenance phase included all participants who responded to golimumab induction treatment and subsequently randomized at Week 0 in maintenance phase. Data for this outcome was not planned to be analyzed for participants who had not responded to golimumab induction dosing, as pre-specified in protocol.|||participants|||Number
2629535|NCT01863758|Secondary|Dosage Per Week in Phase II|The mean dosage per week during Phase II of the study are reported.|Beginning to the end of Phase II (6 months)|Prophylactic treatment population: All participants who received at least 1 dose of Human-cl rhFVIII in Phase II and had any data collected after treatment with Human-cl rhFVIII.|||IU/kg||Standard Deviation|Mean
2629536|NCT01863758|Secondary|Median Dosing Interval During Individually Tailored Prophylaxis|The median time between 2 prophylactic doses of Human-cl rhFVIII in the prophylactic treatment phase II were determined per patient|Beginning to the end of Phase II (6 months)|Prophylactic treatment population: All participants who received at least 1 dose of Human-cl rhFVIII in Phase II and had any data collected after treatment with Human-cl rhFVIII.|||Hours||Inter-Quartile Range|Median
2629537|NCT01863758|Secondary|Annualized Number of Bleeding Episodes (BE) in Phase II in Participants With ≤ 2 Treatments/Week|The annualized number of BEs was calculated for each participant as follows: d*y/t, where y = the number of BEs documented in Phase II, t = the number of treatment periods in days, and d = 365.25, the number of days per year. A bleeding episode (BE) was defined as a BE whether treated or not during Phase II of the study. BEs related to surgery were not included.|Beginning to the end of Phase II (6 months)|Prophylactic treatment population: All participants who received at least 1 dose of Human-cl rhFVIII in Phase II and had any data collected after treatment with Human-cl rhFVIII. Only participants who received ≤ 2 treatments/week were included in the analysis.|||Annualized number of bleeding episodes||Standard Deviation|Mean
2629538|NCT01863758|Secondary|Annualized Number of Spontaneous Bleeding Episodes (BE) in Phase II|The annualized number of spontaneous BEs was calculated for each participant as follows: d*y/t, where y = the number of spontaneous BEs documented in Phase II, t = the number of treatment periods in days, and d = 365.25, the number of days per year. A spontaneous bleeding episode (BE) was defined as a BE whether treated or not during Phase II of the study. BEs related to surgery and BEs due to trauma or due to other causes were not included.|Beginning to the end of Phase II (6 months)|Prophylactic treatment population: All participants who received at least 1 dose of Human-cl rhFVIII in Phase II and had any data collected after treatment with Human-cl rhFVIII.|||Annualized number of bleeding episodes||Standard Deviation|Mean
2629539|NCT01863758|Primary|Annualized Number of Bleeding Episodes (BE) in Phase II|The annualized number of total BEs was calculated for each participant as follows: d*y/t, where y = the number of BEs documented in Phase II, t = the number of treatment periods in days, and d = 365.25, the number of days per year. A bleeding episode (BE) was defined as any BE whether treated or not during Phase II of the study; BEs related to surgery were not included. This study was considered as showing efficacy if the annualized number of BEs was reduced by 50% compared to the number of BEs observed in study GENA-01 where patient where severe Hemophilia A patients were treated on-demand (NCT00989196).|Beginning to the end of Phase II (6 months)|Prophylactic treatment population: All participants who received at least 1 dose of Human-cl rhFVIII in Phase II and had any data collected after treatment with Human-cl rhFVIII.|||Annualized number of bleeding episodes||Standard Deviation|Mean
2651623|NCT01660893|Secondary|Number of Participants With Heart Rate Higher Than 125 Bpm||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
2629540|NCT01863732|Secondary|Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260|ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group|Week 104 to Week 260|Extension Full Analysis Set (FAS): all participants enrolled in the extension study. No Statistical Analysis was performed|||% of responders|||Number
2629541|NCT01863732|Primary|Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260|ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group.|Week 104 to Week 260|Extension Full Analysis Set (FAS): all participants enrolled in the extension study. No Statistical Analysis was performed|||% of responders|||Number
2629542|NCT01863680|Secondary|Serum Progesterone Level|Two pharmacokinetic (PK) samples were collected per subject for the measurement of serum progesterone concentrations; 1st sample at Visit 2-2 (prior to hCG administration) and second sample during Visit 5 (Day 14+/-3, 7 hours after the morning of investigational medicinal product administration).|Visit 2-2 (Prior to hCG administration) and Visit 5 (Day 14+/-3)|"The PK analysis set included all subjects who had serum beta-hCG pregnancy test performed at Visit 5 (Day 14+/-3), who had two progesterone concentrations at Visit 2-2 and Visit 5, and who had no relevant problems for compliance of administration until Visit 5. n signifies the number of subjects who were evaluable in each category, respectively."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2629543|NCT01863680|Secondary|Biochemical Pregnancy Rate Per Embryo Transfer|Biochemical pregnancy was defined as any miscarriage without any evidence of a fetal sac on TVUS during Visit 6 (Week 5), but with a positive serum beta-hCG pregnancy test result at Visit 5 (Day 14+/-3). Biochemical pregnancy rate was calculated as the number of subjects who had no fetal sac observed during Visit 6 (Week 5) TVUS assessment or subjects who had a positive serum pregnancy test at Visit 5 (Day 14+/-3) and no data recorded at Visit 6 (Week 5) divided by the number of subjects who has at least 1 embryo transferred.|Week 5 post embryo transfer (2-6 days after Ovum Pick-up [OPU])|The intention-to-treat subjects included all the subjects who underwent IVF/ET.|||Percentage of pregnancy/embryo transfer|||Number
2629544|NCT01863680|Primary|Clinical Pregnancy Rate Per Embryo Transfer|Clinical pregnancy was defined as the presence of a fetal sac on transvaginal ultrasound (TVUS) during Week 5 or the presence of an extra-uterine pregnancy (as confirmed during surgery or by 2 positive serum beta-human chorionic gonadotropin (beta-hCG) results from Week 5). The clinical pregnancy rate was calculated as number of subjects who were clinically pregnant divided by the number of subjects who had at least 1 embryo transferred.|Week 5 post embryo transfer (2-6 days after Ovum Pick-up [OPU])|The intention-to-treat subjects included all the subjects who underwent IVF/ET.|||Percentage of pregnancy/embryo transfer|||Number
2629545|NCT01863667|Secondary|Change From Baseline in Body Weight at Week 54|Body weight was to be measured (in duplicate) using a calibrated digital scale.|Baseline and Week 54|All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received. Due to the early termination of the study, no participants completed Week 54.||||||
2629546|NCT01863667|Secondary|Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia|An adverse event (AE) is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. AEs may include the onset of new illness and the exacerbation of pre-existing conditions. Per protocol, an adverse event was defined as symptomatic hypoglycemia if hypoglycemia was an adverse event collected on the AE form AND the symptoms associated with it were collected on the hypoglycemia assessment (HA) form. Due to the early termination of the study, the HA form information was not assessed; therefore, this endpoint cannot be reported.|Up to 54 weeks|All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.||||||
2629547|NCT01863667|Secondary|Percentage of Participants Meeting the Composite Endpoint of an A1C Decrease >0.5%, No Symptomatic Hypoglycemia, and No Body Weight Gain After 54 Weeks of Treatment|Percentage of Participants who had an A1C decrease >0.5%, no symptomatic hypoglycemia, and no body weight gain after 54 weeks of treatment|54 weeks|Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.||||||
2629548|NCT01863667|Secondary|Percentage of Participants Achieving an A1C Goal <7.0% or <6.5% After 54 Weeks of Treatment|Percentage of participants achieving glycemic goal (A1C <7% or <6.5%) after 54 weeks of treatment.|54 weeks|Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.||||||
2629549|NCT01863667|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54|This change from baseline reflects the FPG level at Week 54 minus the FPG level at Week 0.|Baseline and Week 54|Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.||||||
2629629|NCT01861574|Secondary|Correctly Guessed Assignment Condition at 4 Hours|Participants were asked to guess whether they received real or sham TMS after each rTMS session. The results below report the percentage or participants that correctly guessed TMS Condition after the second TMS treatment, 4 hours after surgery.|After second TMS treatment (Check up 4)||||percentage of participants|||Number
2629550|NCT01863667|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 54 weeks|All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.|||Percentage of participants|||Number
2629551|NCT01863667|Primary|Percentage of Participants Who Experienced at Least One Adverse Event|An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 57 weeks (including 3 weeks following the last dose of study drug)|All participants as treated defined as all randomized participants who received at least one dose of study drug and were included in the treatment group corresponding to the study drug they actually received.|||Percentage of participants|||Number
2629552|NCT01863667|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 54|A1C is measured as a percent. Thus, this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.|Baseline and Week 54|Full Analysis Set defined as all participants who received at least one dose of study drug and had a baseline measurement or a post-randomization measurement. Due to the early termination of the study, no participants completed Week 54.||||||
2629553|NCT01863563|Primary|Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds|After removal of the adenoids, a tonsil pack wrapped in QuikClot will be placed in the nasopharynx. The investigators will then perform tonsillectomy with the Microdebrider. A QuikClot roll will be placed in the tonsil fossa, and pressure applied via tonsil sponge for one minute. The contralateral tonsil will then be addressed with the same technique. The QuikClot adenoid pack is then removed and residual adenoidal bleeding is addressed with suction electrocautery, followed by placement of a second QuikClot adenoid pack. The tonsil rolls are sequentially removed, followed by control of residual hemostasis with suction electrocautery. A second set of tonsil rolls are placed. After adenoid pack is removed from nasopharynx and bleeding controlled, tonsil rolls are removed, followed by suction electrocautery for any residual hemostasis is performed.|at the time of surgery, 1 hour||||seconds||Standard Deviation|Mean
2629554|NCT01863433|Secondary|Type and Frequency of Any Unsolicited AEs|The percentage of participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited.|After vaccination until the end of the study; approximately 21 days.|The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.|||percentage of participants|||Number
2629555|NCT01863433|Secondary|Type and Frequency of Any Solicited Adverse Events (AEs)|The percentage of participants reporting any solicited AEs.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.|||percentage of participants|||Number
2629556|NCT01863433|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.|For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected.|Approximately 21 days after vaccination|The Evaluable Population includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.|||percentage of participants||95% Confidence Interval|Number
2629557|NCT01863433|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI (H1N1, H3N2, and B influenza virus strains) is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.|||fold increase||Standard Deviation|Geometric Mean
2629558|NCT01863433|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion (H1N1, H3N2, and B influenza virus strains) is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10. A significant increase (H1N1, H3N2, and B influenza virus strains) is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population includes all participants who were vaccinated with Trivalent Influenza Vaccine, provided both pre- and post-vaccination antibody titre results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.|||percentage of participants||95% Confidence Interval|Number
2629559|NCT01863368|Secondary|Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I)|The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment inconvenience scored on a 0-4 Likert-type scale, where 0=All of the time, 1=Most of the time, 2=Some of the time, 3=A little of the time, and 4=None of the time. The IDEEL score for treatment inconvenience was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.|Day 35|This analysis group includes all subjects with data at visit.|||units on a scale||Standard Deviation|Mean
2629560|NCT01863368|Secondary|Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I)|The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment effectiveness scored on a 0-4 Likert-type scale, where 0=None of the time, 1=A little of the time, 2=Some of the time, 3=Most of the time, and 4=All of the time. The IDEEL score for treatment effectiveness was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.|Day 35|This analysis group includes all subjects with data at visit.|||units on a scale||Standard Deviation|Mean
2629561|NCT01863368|Secondary|Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I)|The OSDI is a 12-item, quality of life questionnaire that evaluates symptoms based on 3 modules (type of discomfort, environmental triggers, and tasking) on a 0-4 Likert scale (0=None of the time, 4=All of the time). A resultant overall 0-100 score was calculated, where 0=No disability and 100=Complete disability. Both eyes contributed to the analysis.|Day 35|This analysis group includes all subjects with data at visit.|||units on a scale||Standard Deviation|Mean
2629562|NCT01863368|Primary|Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)|The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis.|Baseline, Day 35|This analysis group includes all randomized subjects with data at visit.|||units on a scale||Standard Deviation|Mean
2629563|NCT01863134|Primary|Major Adverse Cardiac and Cerebrovascular Events (MACCE)|MACCE was defined as combined death, nonfatal myocardial infarction, cerebrovascular event (stroke) and the need for re-hospitalization due to recurrent ischemia up to 12 months follow-up|Up to 12 month||||Percentage of study group|||Number
2629564|NCT01863030|Post-Hoc|Tenderness Assessment|Tenderness measure on a numeric rating scale (0=no tenderness, 10= extreme tenderness)|24 months|31 patients were implanted. patients were lost to follow up at 3 months, 6 months, 12 months, and 24 months post operation.|||units on a scale||Inter-Quartile Range|Median
2629565|NCT01863030|Post-Hoc|Pain Assessment|Pain rating on a numeric rating scale (0=no pain, 10=extreme pain)|up to 24 months post surgery|31 patients were implanted with phasix mesh. Patients were lost to follow up at 3 months, 6 months, 12 months, and 24 months post operation.|||units on a scale||Inter-Quartile Range|Median
2629566|NCT01863030|Other Pre-specified|Abdominal Wall Function|Abdominal wall strength will be measured using the trunk mobility measurements, curl up performance test and EPIC lift capacity test preoperatively, 3 months (+/- 1 month) postoperatively and 12 months postoperatively|up to 12 months post surger|||||||
2629567|NCT01863030|Other Pre-specified|Abdominal Wall Mobility|Abdominal wall strength will be measured using the trunk mobility measurements, curl up performance test and EPIC lift capacity test preoperatively, 3 months (+/- 1 month) postoperatively and 12 months postoperatively.|12 Months|||||||
2629568|NCT01863030|Other Pre-specified|Mental Health Quality of Life Outcome|Quality of life survey- Short Form 12 Mental Health subdomain. assesses level of mental health. Scale ranges from 0-100. Low scores indicate depression and nervousness. High scores indicate feeling peaceful, happy, and calm.|baseline, 12 months, 24 months|31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation.|||units on a scale||Standard Deviation|Mean
2629569|NCT01863030|Other Pre-specified|Social Functioning Quality of Life Outcome|Quality of life survey- Short Form 12 Social Functioning subdomain. Assesses ability to participate in normal social activities without difficulties due to physical or emotional health problems. Scores are normalized to 0-100, with 50 being the national normalized mean. Lower scores indicate many difficulties with normal social activities due to physical or emotional health problems. Higher scores indicate little or no difficulties with normal social activities due to physical or emotional health problems.|baseline, 12 months, 24 months|31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation|||units on a scale||Standard Deviation|Mean
2629570|NCT01863030|Other Pre-specified|Vitality Quality of Life Outcome|Quality of life survey- Short Form 12 Vitality subdomain. Assesses level of energy. Scales range from 0-100. Low scores indicate low levels of energy, while high scores indicate high levels of energy.|baseline, 12 months, 24 months|31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation.|||units on a scale||Standard Deviation|Mean
2629571|NCT01863030|Other Pre-specified|Mental Component Summery|Quality of life survey- Short Form 12 Mental Component Summery. Assesses level of mental health. Scales range from 0-100. Low scores indicate nervousness and depression. High scores indicate feeling peaceful, happy, and calm.|baseline, 12 months, 24 months|31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation|||units on a scale||Standard Deviation|Mean
2629572|NCT01863030|Other Pre-specified|General Health Quality of Life Outcome|Quality of life survey- Short Form 12 General Health Subdomain. Assesses level of general health related to . Scales 0-100. low scores indicate poor general health, and high scores indicate good general health.|baseline, 12 months, 24 months|31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation|||units on a scale||Standard Deviation|Mean
2629573|NCT01863030|Other Pre-specified|Bodily Pain Quality of Life Outcome|Quality of life survey- Short Form 12 Bodily Pain subdomain. Assesses level of bodily pain. scales range from 0-100. low scores indicate a severe level of pain that is limiting. High scores indicate a low level of pain or no pain-related limitations.|baseline, 12 months, 24 months|31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation|||units on a scale||Standard Deviation|Mean
2629574|NCT01863030|Other Pre-specified|Role Physical Quality of Life Outcome|Quality of life survey- Short Form 12 Role physical subdomain. Assesses ability to perform physical activity such as bathing and dressing one's self. Scales range from 0-100. Low scores indicate problems with physical activities. High scores indicate no problems performing physical activities.|baseline, 12 months, 24 months|31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation|||units on a scale||Standard Deviation|Mean
2629575|NCT01863030|Other Pre-specified|Physical Functioning Quality of Life Outcome|Quality of life survey- Short Form 12 Physical Functioning subdomain. Assesses ability to perform physical activities, including bathing and dressing one's self. Scales range from 0-100. Low scores indicate many limitations with physical activities. High scores indicate no problems with physical activities.|baseline, 12 months, 24 months|31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation|||units on a scale||Standard Deviation|Mean
2629685|NCT01860651|Secondary|Absence From School|Number of days absence from school|Prospective, each third month, - disease activity each month(project A) or week(project B), in 2 years||||days||Standard Error|Mean
2654580|NCT01634269|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||12 months||||mmHg||Standard Deviation|Mean
2629576|NCT01863030|Other Pre-specified|Role Emotional Quality of Life Outcome|Quality of life survey- Short Form 12 Role emotional subdomain. This assesses if the patient experiences problems with work or other daily activities as a result of their emotional health. Scales range from 0-100. Low scores indicate the patient experiences many problems at work or with other daily activities as a result of poor emotional health. High scores indicate no problems with work or daily activities as a result of emotional health.|baseline, 12 months, 24 months|31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation.|||units on a scale||Standard Deviation|Mean
2629577|NCT01863030|Other Pre-specified|Physical Component Summery|Quality of life survey- Short Form 12. Physical component summery. Assessment of physical limitations such as bathing, dressing, or physical activities. Scales range from 0-100. Low scores indicate someone with many limitations, while high scores indicate someone with no or few limitations.|baseline, 12 months, 24 months|31 patients were implanted with phasix mesh. Patients were lost to follow up at 12 months and 24 months post operation|||units on a scale||Standard Deviation|Mean
2629578|NCT01863030|Primary|Number of Participants With Recurrent Ventral and Incision Hernias Post Repair With Phasix™ Mesh|Number of participants with recurrent ventral and incision hernias post repair with Phasix™ Mesh. Hernia recurrence is measured by physical exam.|up to 24 months post surgery||||Participants|||Count of Participants
2629579|NCT01863017|Secondary|Three-Factor Eating Questionnaire|The Three-Factor Eating Questionnaire is a self-completed, 51-item questionnaire that measures both cognitive and behavioral aspects of eating (dietary restraint, disinhibition, and hunger), and comprises two parts. Part 1 includes 36 true/false questions, and part 2 includes 14 questions on a four point Likert scale (1= rarely, 2 = sometimes, 3 = usually, 4 = always) and 1 question on a five point Likert scale (1 = eat whatever you want, whenever you want it to 5 = constantly limiting food intake, never 'giving in'; other questions). Higher scores indicate more severe pathology.|Total Scores at Day 30|All participants|||score on a scale||Standard Deviation|Mean
2629580|NCT01863017|Primary|Dykens Hyperphagia Questionnaire|The Dykens Hyperphagia Questionnaire is a 13-item instrument that was specifically designed to measure food-related preoccupations and problems, as well as the severity of these concerns. Items on the questionnaire are rated on a five-point scale (1: not a problem to 5: severe and/or frequent problem). Possible scores on the questionnaire range from a minimum score of 0 to a maximum score of 65. Higher scores indicate greater hyperphagia.|Total Score Day 30|all participants|||score on a scale||Standard Deviation|Mean
2629581|NCT01863017|Primary|Amplitude of Eyeblink Startle Responses|Muscle contractions generated by the orbicularis oculi were recorded by a BIOPAC systems bioamplifier (model EMG 100c) passing 10-500 Hz signals, sampling at a rate of 2000/second and amplified by a factor of 5000. Eyeblink startle-responses were measured in response to food and non-food images at two lead-intervals (2500 ms and 6000 ms) to assess emotional responses (e.g., early and late, respectively) for each picture stimulus. Startle responses were assessed during (e.g., while viewing the food, puppy, etc.) and between (e.g., during washout periods; no-images) visual image-processing. Omnibus amplitudes are presented for sham vs active treatment groups for all participants, individuals with obesity and Prader Willi syndrome relative to lean controls.|Amplitude of Eyeblink Startle at Day 30 relative to normal weight controls|All participants|||microvolts||Standard Error|Mean
2629582|NCT01862991|Secondary|Adverse Events|Uterine perforation|Intraoperatively and 2 weeks post operatively||||Participants|||Count of Participants
2629583|NCT01862991|Primary|Procedure Time|Measured as time from speculum insertion to removal|Intraoperative Time, Collected immediately within procedure||||minutes||Full Range|Median
2629584|NCT01862874|Secondary|Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection or Disease|Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The incidence of persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed. Disease was defined as HPV Type 6, 11, 16, or 18-related condyloma acuminate, PIN, penile, perianal, or perineal cancer. The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection or disease was assessed.|Up to Month 36|Participants who were seronegative at Day 1 and PCR negative from Day 1 through Month 7 to the relevant HPV type, received all 3 vaccinations, did not deviate from the study protocol in ways that might interfere with vaccine efficacy, and had ≥1 follow-up visit after Month 7.|||Cases per 100 person-years at risk|Person-years follow-up||Number
2629585|NCT01862874|Primary|Percentage of Participants With a Vaccine-related Systemic Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. Vaccine-related AEs are those that were deemed possibly, probably, or definitely related to vaccine administration by the investigator. The percentage of participants with a vaccine-related systemic AE was summarized.|Up to 15 days after any vaccination|Participants who received ≥1 study vaccination and had follow-up data available.|||Percentage of participants|||Number
2629586|NCT01862874|Primary|Percentage of Participants With a Systemic Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The percentage of participants with a systemic AE was summarized.|Up to 15 days after any vaccination|Participants who received ≥1 study vaccination and had follow-up data available.|||Percentage of participants|||Number
2629704|NCT01860521|Secondary|Total Levobupivacaine Consumption||At the moment of fetal expulsion (up to 66 hours from starting of the procedure).||||mg||Standard Deviation|Mean
2629587|NCT01862874|Primary|Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card|An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The percentage of participants with an injection-site AE prompted on the VRC (erythema, pain, and swelling) was summarized.|Up to 5 days after any vaccination|Participants who received ≥1 study vaccination and had follow-up data available.|||Percentage of participants|||Number
2629588|NCT01862874|Primary|Percentage of Participants With Maximum Temperature ≥37.5°C Reported on the Vaccination Report Card|Body temperature (oral or oral equivalent) was recorded on the Vaccination Report Card (VRC). The percentage of participants with a maximum temperature ≥37.5°C was summarized.|Up to 5 days after any vaccination|Participants who received ≥1 study vaccination and had follow-up data available.|||Percentage of participants|||Number
2629589|NCT01862874|Primary|Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection|Persistent infection was defined as 1) polymerase chain reaction (PCR) positive to HPV Type 6, 11, 16, or 18 in 2 consecutive anogenital or biopsy samples collected ≥4 months apart, or 2) Pathology Panel consensus diagnosis of condyloma acuminate, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer and PCR detection of HPV Type 6, 11, 16, or 18 in an adjacent section and PCR positive for the same HPV type at a separate adjacent visit. The combined incidence of HPV Type 6, 11, 16, or 18 persistent infection detected in samples from ≥2 consecutive visits ≥6 months apart was assessed.|Up to Month 36|Participants who were seronegative at Day 1 and PCR negative from Day 1 through Month 7 to the relevant HPV type, received all 3 vaccinations, did not deviate from the study protocol in ways that might interfere with vaccine efficacy, and had ≥1 follow-up visit after Month 7.|||Cases per 100 person-years of follow-up|Person-years follow-up||Number
2629590|NCT01862796|Secondary|Change in Weight From Baseline to 6 Weeks|Weight loss from baseline, calculated as weight at 6 weeks - weight at baseline|6 weeks||||kg||Standard Deviation|Mean
2629591|NCT01862796|Primary|Adherence Score|An adherence score is calculated each week by summing 7 measurements of adherence and dividing by 21, the maximum score, with range from 0 (no adherence) to 1 (perfectly adherent). For each of the 7 measures a higher score means better adherence: [1] Attendance (0-2), [2] Food diaries (0-3), [3] 24-hour food recall via interview (0-3), [4] computer survey (0-3), [5] 24-hour food recall via interview (0-3), [6] Ecological momentary assessment (0-6), and [7] On time arrival for session (0-1). The final score is calculated as the average of the six weekly scores.|Average over 6 weeks||||score on a scale||Standard Deviation|Mean
2629592|NCT01862484|Primary|ADHD Rating Scale IV|The ADHD Rating Scale is an 18 items scale containing items related to the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD). It is filled out by the parent. Each item is rated 0-3, the range of scores is 0 to 54, with 25 being the score below which the patient is considered to be in remission. Reference: DuPaul GJ, Power TJ, Anastopoulos AD, Reid R: ADHD Rating Scales-IV: Checklists, Norms and Clinical Interpretation. New York, Guilford Press; 1998.|5 weeks|Children with ADHD who completed the five week diet and parents filled out the ADHD rating scale.|||units on a scale||Standard Deviation|Mean
2629593|NCT01862419|Primary|Relative Maximum Change in Creatinine||7 days of randomization||||relative percent change||Inter-Quartile Range|Median
2629594|NCT01862419|Primary|Death||7 days of randomization||||participants|||Number
2629595|NCT01862419|Primary|Dialysis Within 7 Days|This metric will be sequentially ranked. The provision of acute dialysis therapy will be ranked as a more severe outcome than the worst relative change in creatinine and death will be ranked as a more severe outcome than dialysis.|From start of AKI to 7 days later||||participants|||Number
2629596|NCT01862250|Secondary|Time to Passive Rewarming|Following 2 hours of therapeutic hypothermia, the temperature of the thermo-blanket is adjusted up half degree per hour allowing passive rewarming until 36.5 degrees is reached|Beginning at 72 hours up to 12 hours||||Hours||Inter-Quartile Range|Median
2629597|NCT01862250|Secondary|Presence of Shivering After Clonidine|Babies were assessed after administration of clonidine for the presence or absence of shivering.|48hrs||||Participants|||Count of Participants
2629598|NCT01862250|Primary|Amount of Morphine Given|Intravenous morphine (mg/kg) was given. The standard dose is 0.05 mg/kg per dose|Up to 2 days||||mg/kg||Inter-Quartile Range|Median
2629599|NCT01862250|Primary|Steady State Clonidine Blood Levels During Hypothermia|"Trough clonidine blood levels were measured after 4-7 doses of clonidine were given intravenously with a dosing interval of every 8 hrs. Mean and standard deviation (SD) of the number of doses given prior to levels being drawn was 5.3 (mean) and 0.37 (SD).~Time after last dose before measurement was 9hrs (mean) and 2.7hrs (SD)."|3 days|Only 8 babies were assessed for this outcome because the rest did not have a steady state trough level performed during cooling|||ng/ml||Full Range|Median
2629600|NCT01862159|Secondary|Specific Postoperative Complications|Any complication (Anastomotic leakage/abscesses, bleeding, small bowel obstruction, stomal ulcera, cardiovascular complications, pulmonary complications, venous thromboembolism, port site complication, other complication)|30 days or the postoperative hospital stay if longer than 30 days||||Participants|||Count of Participants
2629601|NCT01862159|Secondary|Length of Stay|Length of stay after the primary operation|30 days or the postoperative hospital stay if longer than 30 days||||days||Standard Deviation|Mean
2629602|NCT01862159|Secondary|Operating Time|length of the operation|operation||||minutes||Standard Deviation|Mean
2629603|NCT01862159|Primary|Serious Complications|Graded as Clavien 3b or more (for patients entered in the registry after January 1st 2010)|30 days or the postoperative hospital stay if longer than 30 days|All patients operated after Jan 1, 2010|||Participants|||Count of Participants
2629604|NCT01862133|Primary|Providers' Opinion of Patients' Controlling EHR Access|"Percent of providers answering Strongly Agree or Agree to the following question on the post-study survey: I think it is OK for patients to have control over who sees what information in their electronic health records."|6 month study|||||||
2653308|NCT01644240|Primary|AUCtau|Area under the plasma concentration time curve over the dosing interval estimated using the linear trapezoidal rule.|Day 5||||pg*hr/mL||Standard Deviation|Mean
2629605|NCT01862133|Primary|Number of Patients Recording Preferences to Restrict Provider Access to Some or All Electronic Health Record (EHR) Data|"Patients had to restrict access to either all data or one of five categories of sensitive data (sexually transmitted infections, HIV/AIDS, sexual health and pregnancy, drug and alcohol use and abuse, and mental health information) to one or more of the study providers."|6 month study|All patients recorded their preferences and completed the questionnaire. 24 (77%) of the 31 providers completed the anonymous post-study questionnaire.|||participants|||Number
2629606|NCT01862029|Primary|Change in Insulin Sensitivity - Post-roflumilast|Our primary outcome measure is the change in peripheral insulin sensitivity. The hyperinsulinemic euglycemic clamp procedure's M value, which was obtained post-roflumilast, was used for this primary outcome assessment.|6 weeks|Subjects who underwent the clamp procedure at time point: post-roflumilast|||mg/grams Fat Free Mass/minute||Standard Error|Mean
2629607|NCT01862029|Primary|Change in Insulin Sensitivity- Pre-roflumilast|Our primary outcome measure is the change in peripheral insulin sensitivity. The hyperinsulinemic euglycemic clamp procedure's M value, which was obtained before the subjects began roflumilast, was used to assess the primary outcome.|Baseline|Subjects who underwent the clamp procedure at time point: pre- roflumilast|||mg/grams Fat Free Mass/minute||Standard Error|Mean
2629608|NCT01861925|Post-Hoc|Equivalence of Keratometry Axis Measurement Between Lenstar LS 900 Topography and Lenstar LS 900: Population Mean of Normalized Differences of Keratometry Axis Measurement Between Both Devices.|"For definition of keratometry axis see outcome measures 4 and 5.~This outcome measure aims at testing the equivalence of keratometry axis measurement between Lenstar LS 900 Topography and Lenstar LS 900 (both Haag Streit) by analyzing differences in measurement results for the same eye between both devices.~Reported are: population mean of normalized difference and 95% confidence interval of mean normalized difference for axis of flat meridian.~Difference is normalized for each eye as function of astigmatism to a refractive error of 0.167 diopters (i.e. an axis difference of 1 normalized degree results in a refractive error of 0.167 diopter), to provide a measure which can be directly related to its impact on visual quality.~Please note that for this analysis a separation in arms normal eye and large regular astigmatism is not meaningful, thus here both groups are analyzed jointly as group regular eye"|1 day of examination||||normalized degree||95% Confidence Interval|Mean
2629609|NCT01861925|Other Pre-specified|Equivalence of Keratometry Axis Measurement Between Lenstar LS 900 Topography and Lenstar LS 900: Population Mean of Differences of Keratometry Axis Measurement Between Both Devices.|"Keratometry axis refers to the axis of the flat meridian of the toric representation of the cornea. For additional information see outcome 4.~This outcome measure aims at testing the equivalence of keratometry axis measurement between Lenstar LS 900 Topography and Lenstar LS 900 (both Haag Streit) by analyzing differences in measurement results for the same eye between both devices.~Reported are: population mean of difference and 95% confidence interval of mean difference for axis of flat meridian."|1 day of examination||||degree||95% Confidence Interval|Mean
2629610|NCT01861925|Other Pre-specified|Equivalence of Keratometry Radius Measurement Between Lenstar LS 900 Topography and Lenstar LS 900: Population Mean of Differences of Keratometry Radius Measurement Between Both Devices.|"Keratometry radius refers to the corneal curvature R (see primary measure outcome). In this context, the cornea is approximated by a toric surface which can be characterized by a flat meridian (radius R1) and a steep meridian (radius R2) with an angle of 90 degrees between these meridians.~This outcome measure aims at testing the equivalence of keratometry radius measurement between Lenstar LS 900 Topography and Lenstar LS 900 (both Haag Streit) by analyzing differences in measurement results for the same eye between both devices.~Reported are: population mean of difference and 95% confidence interval of mean difference for radius of flat meridian (R1) and radius of steep meridian (R2)."|1 day of examination||||micrometer||95% Confidence Interval|Mean
2629611|NCT01861925|Other Pre-specified|Equivalence of Corneal Topography Measurement Between Lenstar LS 900 Topography and Atlas 9000: Sample Mean of Std. Dev. of Local Corneal Elevation Differences for One Measurement Per Device.|"For definition of corneal topography, areas of evaluation and methods, see outcome 1 and 2.~Corneal elevation refers to the distance between the measured corneal surface and the best fitting sphere, and is given in µm.~This outcome measure aims at testing the equivalence of corneal topography measurement between Lenstar LS 900 Topography (Haag Streit) and Atlas 9000 (Zeiss) by analyzing differences in measurement results for the same eye between both devices.~elevation difference (2 std. dev.) is the sample mean of twice the standard deviation of local corneal elevation differences between measurements with both devices. This value quantifies the spatially resolved agreement of corneal shape measurement of the two devices."|1 day of examination||||micrometer||95% Confidence Interval|Mean
2629612|NCT01861925|Secondary|Equivalence of Corneal Topography Measurement Between Lenstar LS 900 Topography and Atlas 9000: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences for One Measurement Per Device.|"For definition of corneal topography, corneal power in diopter, areas of evaluation and methods, see outcome 1.~This outcome measure aims at testing the equivalence of corneal topography measurement between Lenstar LS 900 Topography (Haag Streit) and Atlas 9000 (Zeiss) by analyzing differences in measurement results for the same eye between both devices.~power difference (2 devices) is the sample mean and 95% C.I. of differences of spatial mean of corneal power between two devices. This value quantifies systematic differences between devices (e.g. calibration), ignoring local variations of the power measurement.~power difference (2 std.dev.) is the sample mean of twice the standard deviation of local power differences between measurements with both devices. This value quantifies the spatially resolved agreement of corneal shape measurement of the two devices."|1 day of examination||||diopters||95% Confidence Interval|Mean
2629630|NCT01861574|Primary|Sensory Dimension of McGill Pain Questionnaire|"Participants completed the McGill Pain Questionnaire-short form (MPQ) at Check Up 1, Check Up 2, Check Up 3, and Check Up 4. Check Up 1 & 2 occurred on Post-Op Day 1. Check Up 1 occurred immediately after surgery. Check Up 2 occurred 4 hours after Check Up 1. Check Up 3 & 4 occurred on Post-Op Day 2, 4 hours apart.~The MPQ has two pain dimensions: 1.Sensory subscale with 11 words, and 2.Affective subscale with 4 words from the original MPQ. The range of scores for the affective dimension of pain is 0-12.~The range of scores for the sensory dimension of pain is 0-33. The maximum total score for the sensory dimension is 33.~Higher scores are indicative of worse pain on the sensory dimension of pain."|Check Up 1, Check Up 2, Check Up 3, and Check Up 4||||units on a scale||Standard Error|Mean
2653309|NCT01644240|Primary|AUC0-∞|Area under the plasma concentration time curve from 0 to infinity.|Day 5||||pg*hr/mL||Standard Deviation|Mean
2629613|NCT01861925|Primary|In-vivo Repeatability of Corneal Topography Measurements With Lenstar LS 900 Topography: Sample Mean of Differences of Mean Power and Sample Mean of Std. Dev of Local Power Differences Between Two Consecutive Measurements|"Corneal topography is a measurement of the shape of the anterior cornea. The shape of a cornea can be fully quantified by providing a map of local power. Diopter is the unit of refractive power of a lens. In case of the cornea, the power K [diopter] is related to the radius (curvature) R [mm] of the best fitting sphere by the relation K=337.5/R.~Here, corneal topography measurements are implemented by the Placido method, i.e. by analyzing the reflection image of a ring-shaped illumination.~According to International Standards Organization (ISO) 19980-2012, repeatability of corneal topography is assessed on the central cornea: area with diameter d<=3mm, and middle cornea: 3mm<d<=6mm.~power difference (2 rep. meas.): sample mean and 95% C.I. of differences of spatial mean of corneal power between two consecutive measurements.~power difference 2 std.dev.: sample mean of twice the deviation of local power differences (two consecutive measurements)."|1 day of examination||||diopters||95% Confidence Interval|Mean
2629614|NCT01861756|Secondary|Glycemic Control (HbA1c)||3 and 6 months after patient initial encounter|||||||
2629615|NCT01861756|Secondary|Adherence With Antihyperglycemic Regimens as Reported by the Patient Himself/Herself or Assessed Utilizing the Pharmacy Records||3 and 6 months after patient initial encounter|||||||
2629616|NCT01861756|Secondary|Patient and Clinician Satisfaction With the Decision Making Process|"Patient satisfaction will be assessed using items from the Decisional Conflict Scale as well as two specific questions that require patients to assess the extent to which they would want for themselves and recommend to others similar decision support.~Clinician satisfaction will be assessed using a 6-point likert-type question asking about their satisfaction regarding the discussion they had with their patient."|Day 1|||||||
2629617|NCT01861756|Secondary|Degree of Patient Knowledge About Available Treatment Alternatives|Patients will complete a 6-item questionnaire addressing general knowledge about type 2 diabetes.|Day 1|||||||
2629618|NCT01861756|Primary|Overall Decisional Comfort (0-100, 100=no Conflict)|Quality of the decision making process assessed by means of the Decisional Conflict Scale|Day 1||||units on a scale||95% Confidence Interval|Mean
2629619|NCT01861704|Secondary|Gain, Speech Understanding and Sound Quality||During useful lifespan of device|||||||
2629620|NCT01861704|Secondary|Device Comfort||During useful lifespan of device|||||||
2629621|NCT01861704|Primary|Immediate Refit Upon Device Removal|Upon device removal, a qualified audiologist examined subjects' ears to evaluate their availability to be immediately refit with another hearing aid device. It is not uncommon for patients being fitted with these types of devices to experience slight irritation on an initial experience with the device. In particular, those being fit with the Lyric or Lyric2.0 for the first time first undergo the device sizing process, which slightly increases stress on the ear.|Following device removal at the same appointment (Up to 24 hours after removal)|Only ears from experienced users were taken into account, i.e. only users that have previously worn an extended wear device. Some patients previously worn only one hearing instrument, therefor a significant number of patients were only fitted with one instrument|||percentage of ears|Participants|90% Confidence Interval|Number
2629622|NCT01861665|Primary|Wong-Baker Faces Pain Rating Scale|Pain level on post op day 1 and 2 study hypothesize will be less if Marcaine is administered pre instead of post incision. The pain scale is a numeric pain rating scale from 0-5, with zero being no pain and 5 being the worst pain imaginable, faces depicting no pain to worst pain.|Post surgery day 0, post surgery day 1, post surgery day 2||||units on a scale||Standard Deviation|Mean
2629623|NCT01861587|Primary|Average Pain|To assess each participant's pain on average in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their pain on average in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.|Baseline Only||||units on a scale||Standard Deviation|Mean
2629624|NCT01861587|Primary|Average Pain at Worst|To assess each participant's average pain at it's worst in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's worst in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.|Baseline Only||||units on a scale||Standard Deviation|Mean
2629625|NCT01861587|Primary|Average Pain at Least|To assess each participant's average pain at it's least in the past 24 hours, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's least in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.|Baseline and Discharge||||units on a scale||Standard Deviation|Mean
2629626|NCT01861587|Primary|Patient Controlled Analgesia (PCA) Hydromorphone Usage|The PCA pump usage was downloaded from the PCA pump after discharge from the hospital.|Participants were followed for the duration of hospital stay, an average of 48 hours.||||milligrams of hydromorphone||Standard Deviation|Mean
2629627|NCT01861574|Primary|Affective Dimension of McGill Pain Questionnaire|"Participants completed the McGill Pain Questionnaire-short form (MPQ) at Check Up 1, Check Up 2, Check Up 3, and Check Up 4. Check Up 1 & 2 occurred on Post-Op Day 1. Check Up 1 occurred immediately after surgery. Check Up 2 occurred 4 hours after Check Up 1. Check Up 3 & 4 occurred on Post-Op Day 2, 4 hours apart.~The MPQ has two pain dimensions: 1.Sensory subscale with 11 words, and 2.Affective subscale with 4 words from the original MPQ. The range of scores for the affective dimension of pain is 0-12.~The maximum total score for the Affective dimension is 12. Higher scores are indicative of worse pain on the affective dimension of pain."|Check Up 1, Check Up 2, Check Up 3, and Check Up 4||||units on a scale||Standard Error|Mean
2629628|NCT01861574|Secondary|Confidence Ratings of Guessing TMS Condition Assignment|"After participants guessed their TMS condition; whether they received real or sham TMS, They were then asked to rate the confidence in their guess. Ratings were on a scale of 0-10 where 0=complete guess and 10=absolutely sure.~Results below include the mean confidence ratings of those that guessed the TMS condition correctly and those that guessed incorrectly."|After Second TMS Treatment (Check up 4)||||units on a scale||Standard Deviation|Mean
2629631|NCT01861574|Primary|Patient Controlled Analgesia (PCA) Hydromorphone Usage|PCA pump usage values were reported by concentration in mg/mL. Post operative PCA pump usage was tracked 0-48 hours after surgery. The PCA pump usage was downloaded from the PCA pump after discharge from the hospital and values were reported in mg/mL (concentration in mg/mL). The PCA pump data were averaged over Post-operative hours 0-48 (total PCA pump usage post-operatively) and the mean PCA pump usage was calculated and reported in mg/mL for all groups (4).|Post-Op Hour 0 through 48||||mg/ml||Standard Deviation|Mean
2629632|NCT01861522|Secondary|Adverse Events and Adverse Drug Reactions||Week 2|||||||
2629633|NCT01861522|Secondary|Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis||Randomization, Week1 and Week 2|||||||
2629634|NCT01861522|Secondary|Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)||baseline, Week1 and Week 2|||||||
2629635|NCT01861522|Secondary|Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)||baseline, Week1 and Week 2|||||||
2629636|NCT01861522|Secondary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]||baseline, Week1 and Week 2|||||||
2629637|NCT01861522|Primary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]|Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptoms) to 4 (very severe).|Baseline and Week 2||||units on a scale||Standard Error|Least Squares Mean
2629638|NCT01861457|Secondary|Treatment-associated Change in Total Nasal Bacterial Colonization During a Typical 10-hour Work Day|The percent change from morning baseline sample to the evening sample taken at the end of a typical 10-hour workday in treated subjects known to be colonized by Staph aureus.|10 hour workday||||Percent change in colonization||Inter-Quartile Range|Median
2629639|NCT01861457|Primary|Treatment-associated Change in S. Aureus Colonization During a Typical 10-hour Work Day|The percent change from morning baseline sample to the evening sample taken at the end of a typical 10-hour workday in treated subjects known to be colonized by Staph aureus.|10-hour work day|All participants who received 3 scheduled treatments|||Percent change in colonization||Inter-Quartile Range|Median
2629640|NCT01861301|Other Pre-specified|Association Between Baseline HGF, MET Gene Amplification, MET IHC and PFS|Will be evaluated using the Cox regression model.|Baseline to 1 year|||||||
2629641|NCT01861301|Other Pre-specified|Change in Serum HGF or MET IHC and Tumor Size Change (Percent Reduction in Sum of Longest Diameters)|Will be evaluated by Spearman's rank correlation coefficient.|Baseline to 1 year|||||||
2629642|NCT01861301|Other Pre-specified|Change in Baseline Levels of Continuous or Ordinal Markers (e.g., Serum HGF/MET IHC) Between Responders and Non-responders|Fisher's exact test will be performed for binary variables (e.g., presence/absence of MET gene amplification). Paired t-tests or Wilcoxon signed-ranks test, whichever is appropriate, will be used to examine the changes with treatment in the laboratory correlates that are continuous and McNemar's test will be used for binary markers.|Baseline to 1 year|||||||
2629643|NCT01861301|Secondary|Progression-free Survival|Time to disease progression or death from any cause. Analyzed using the Kaplan-Meier method.|Up to 2 years||||Months||95% Confidence Interval|Median
2629644|NCT01861301|Secondary|Overall Survival|Analyzed using the Kaplan-Meier method.|Up to 2 years||||Months||95% Confidence Interval|Median
2629645|NCT01861301|Secondary|Incidence of Adverse Events, Graded Per NCI CTCAE Version 4|Grade 3 or higher AE of any type, regardless of attribution.|Up to 2 years||||percentage of participants||95% Confidence Interval|Number
2629646|NCT01861301|Primary|Objective Radiologic Response Rate (Complete or Partial Response) Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 1 year|Note: Study terminated for futility due to insufficient number of objective responders in first stage.|||percentage of participants||95% Confidence Interval|Number
2629647|NCT01860989|Primary|28-day Cure Rate|28-day cure rate was measured by the endpoint of complete cure without recrudescence before Day 29. The primary variable of 28-day cure rate was defined as the proportion of patients with clearance of asexual parasitemia (by blood film) by day 6 of the study, and without subsequent recrudescence (by blood film).|Day 28|PharmacoDynamic (PD) Analysis Set - All the 11 patients were included in PD analysis set.|||Percentage of participants|||Number
2629648|NCT01860976|Secondary|Percentage of Participants With at Least One Positive Immunogenicity Response up to Day 169 Relative to Baseline|Blood samples were collected at Days 1, 85 and 169 and assayed for the presence of abatacept-specific antibodies. The number of participants with at least one positive immunogenicity response was divided by the number of treated participants and expressed as a percentage.|Baseline to Day 169|All treated participants|||Percentage of participants|||Number
2629649|NCT01860976|Secondary|Mean Change From Baseline in SF-36 Physical and Mental Components at Day 169|Adjusted mean change in scores on the Short Form 36 physical and mental function assessment (SF-36) from baseline were analyzed from the physical component summary (PCS) mental component summary (MCS). The SF-36 is a participant questionnaire assessing 8 domains of health status: physical functioning, pain, vitality, social functioning, psychological functioning, general health perception, and role limitations due to physical and emotional problems. The instrument can be divided into two summary scores, physical and mental component score. The scores range from 0 to 100, with a higher score indicating better quality of life. The two summary scores (PCS and MCS) will be calculated by taking a weighted linear combination of the 8 individual subscales.|Baseline to Day 169|All treated participants|||units on a scale||Standard Error|Mean
2629661|NCT01860846|Secondary|Change in Extra-intestinal Symptoms|Extra-intestinal manifestations of Crohn's Disease (skeletal system [bones and muscle], dermatological [skin], hepatobiliary system [liver, gall bladder, and bile ducts], ocular [eyes] and oral [mouth]) were documented by the study investigators at each visit.|At baseline and 12 months|Participants with available data|||Participants|||Count of Participants
2630445|NCT01854047|Primary|Absolute Change From Baseline in FEV1 at Week 12: ITT Population|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|ITT population.|||liter||Standard Deviation|Mean
2629650|NCT01860976|Secondary|Percentage of ACR 50 and ACR 70 Responders at Day 169|The ACR 50 and ACR 70 definition of improvement is a 50% or 70% improvement, respectively, over baseline in tender and swollen joint counts and a 50% or 70% improvement in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 50 and ACR 70 responders was divided by the number of treated participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.|Day 169|All treated participants|||Percentage of participants||95% Confidence Interval|Number
2629651|NCT01860976|Secondary|Percentage of Participants Achieving a PASI 50 at Day 169 in Participants With Baseline BSA >= 3%|The number of participants who achieved at least 50% improvement from baseline in Psoriasis Area and Severity Index Arthritis (PASI 50) at Day 169 was divided by the number of treated participants with BSA >= 3% and expressed as a percentage. Only participants with >= 3% body surface area (BSA) of psoriatic skin involvement at randomization were included in this analysis.|Baseline to Day 169|All treated participants with >= 3% BSA of psoriatic skin involvement at randomization|||Percentage of participants||95% Confidence Interval|Number
2629652|NCT01860976|Secondary|Percentage of Non-progressors in Total PsA-modified SHS at Day 169|The number of radiographic non-progressors in total PsA-Modified Sharp van der Heijde score (SHS) at Day 169 was divided by the number of treated participants and expressed as a percentage. Non-progression was defined as a change from baseline in total PsA modified SHS ≤0. Early escape participants, and participants with missing data at day 169 were imputed as non-progressors.|Baseline to Day 169|All treated participants|||Percentage of participants||95% Confidence Interval|Number
2629653|NCT01860976|Secondary|Percentage of ACR 20 Responders at Day 169 in the TNFi-exposed Subpopulation|The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated, TNFi-exposed participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.|Day 169|All treated TNFi-exposed participants|||Percentage of participants||95% Confidence Interval|Number
2629654|NCT01860976|Secondary|Percentage of ACR 20 Responders at Day 169 in the TNFi-naïve Subpopulation|The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated, TNFi-naive participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.|Day 169|All treated TNFi-naïve participants|||Percentage of participants||95% Confidence Interval|Number
2629655|NCT01860976|Secondary|Percentage of Health Assessment Questionnaire (HAQ) Responders at Day 169|"Participants were considered responders if their HAQ score decreased at least 0.35 from baseline. The number of HAQ responders was divided by the number of treated participants and expressed as a percentage. Scoring conventions are based on the Standard Disability Index of HAQ/HAQ-DI using the 20 response items. For each of the 8 disability categories there is an aids/devices companion variable that is used to record the type of assistance, if any, a participant uses for his/her usual activities. If either aids/devices and/or assistance from another person are checked for a disability category, the score for this category is set to 2 (much difficulty), if the original score was 0 (no difficulty) or 1 (some difficulty). The HAQ-DI is then calculated by summing the adjusted categories scores and dividing by the number of categories answered. Early escape participants, and participants with missing data at day 169 were imputed as non-responders."|Baseline to Day 169|All treated participants|||percentage of participants||95% Confidence Interval|Number
2629656|NCT01860976|Primary|Percentage of ACR 20 Responders at Day 169|The American College of Rheumatology (ACR) 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% improvement in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.|Day 169|All treated participants|||Percentage of participants||95% Confidence Interval|Number
2629657|NCT01860950|Secondary|Percentage of Participants That Correctly Guessed Condition Assignment|Participants guessed whether they received real tDCS or Sham tDCS. The base-rate for correctly guessing real versus sham was 50%.|2 hours||||percentage of participants|||Number
2629658|NCT01860950|Primary|Post-Intervention Pain Tolerance|Participants will undergo comprehensive laboratory pain assessment including hot and cold, sensory and pain threshold assessment using the Method of Limits with the Pathway Thermo-sensory Analyzer System (Medoc Inc., NC) which is specifically designed for assessing laboratory pain perception.|Duration of the study visit, approximately 2 hours||||celcius||Standard Deviation|Mean
2629659|NCT01860950|Primary|Pre-Intervention Pain Tolerance|Participants will undergo comprehensive laboratory pain assessment including hot and cold, sensory and pain threshold assessment using the Method of Limits with the Pathway Thermo-sensory Analyzer System (Medoc Inc., NC) which is specifically designed for assessing laboratory pain perception.|Duration of the study visit, approximately 2 hours||||celcius||Standard Deviation|Mean
2629660|NCT01860846|Secondary|Number of Participants With Serious Adverse Events|A serious adverse event was defined as any untoward medical occurrence in a clinical investigation participant that met at least 1 of the following criteria: death, life-threatening, hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, important medical event requiring medical or surgical intervention to prevent serious outcome, elective or spontaneous abortion.|From the time of informed consent until 30 days or 5 half-lives following the last dose, up to 62 weeks|All enrolled participants|||Participants|||Count of Participants
2629662|NCT01860846|Secondary|Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32-item self-administered questionnaire to measure health-related quality of life in adults with Crohn's Disease. The 32 items are grouped into subscales: bowel-related symptoms (10 items), systemic symptoms (5 items), social function (5 items), and emotional function (12 items). Responses to each item within each subscale range from 1 (significant impairment) to 7 (no impairment), and mean scores ranging from 1 to 7 are calculated for each subscale. Higher scores indicate a better quality of life.|At baseline and 12 months|Participants with available data|||units on a scale||Standard Deviation|Mean
2629663|NCT01860846|Secondary|Change in Short Form 36 (SF-36) Health Survey Scores|"The Short Form 36 (SF-36) Health Survey was used to determine participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scores on each item were summed and averaged (range = 0 worst to 100 best). Increases from baseline indicate improvement."|At baseline and 12 months|Participants with available data|||units on a scale||Standard Deviation|Mean
2629664|NCT01860846|Primary|Total Activity Impairment (TAI)|The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn's Disease. The self-administered questionnaire consisted of 6 questions. Question 6 asked participants to indicate the degree to which their health affected their regular activities in the past 7 days. Total activity impairment is the percent impairment of non-work related activities due to health problems and was calculated with the formula (Q6/10) × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|At baseline and 12 months|Participants with available data|||units on a scale||Standard Deviation|Mean
2629665|NCT01860846|Primary|Total Work Productivity Impairment (TWPI)|The Work Productivity and Activity Impairment: General Health (WPAI:GH) self-administered questionnaire was used to assess impairments in work due to symptoms of Crohn's Disease. Q2 asked participants the number of hours missed due to health problems in the past 7 days. Q4 asked participants the number of hours that they worked in the past 7 days. Q5 asked participants the degree to which their health affected productivity while working in the past 7 days, on a scale ranging from 0 (health problems had no effect) to 10 (health problems completely prevented them from working). Total work productivity impairment (TWPI) is the combined absenteeism and presenteeism for employed participants, the percentage of overall work productivity lost due to health problems. TWPI was calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4)))×(Q5/10)] × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|At baseline and 12 months|Participants with available data|||units on a scale||Standard Deviation|Mean
2629666|NCT01860846|Primary|Work Productivity and Activity Index (WPAI): Presenteeism|The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn's Disease. The self-administered questionnaire consisted of 6 questions. Question 5 asked participants the degree to which their health affected productivity while working in the past 7 days, on a scale ranging from 0 to 10, with 0 indicating that health problems had no effect on their work and 10 indicating that health problems completely prevented the participant from working. Presenteeism (impairment at work) was calculated by the formula (Q5/10) × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|At baseline and 12 months|Participants with available data|||units on a scale||Standard Deviation|Mean
2629667|NCT01860846|Primary|Work Productivity and Activity Index (WPAI): Absenteeism|The Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire was used to assess impairments in both paid work and unpaid work due to symptoms of Crohn's Disease. The self-administered questionnaire consisted of 6 questions. Question 2 asked participants to indicate the number of hours missed due to health problems in the past 7 days. Question 4 asked participants to indicate the number of hours that they worked in the past 7 days. Absenteeism (work time missed) was defined as the percentage of time absent from work due to health problems in the past week and was calculated by the formula Q2/(Q2 + Q4) × 100%. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|At baseline and 12 months|Participants with available data|||units on a scale||Standard Deviation|Mean
2629668|NCT01860807|Primary|Methamphetamine Use|End of treatment methamphetamine abstinence|12 weeks||||Participants|||Count of Participants
2629669|NCT01860703|Secondary|Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of Moxifloxacin|"Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.~ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|Cardiodynamic Analysis Set : all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).|||milliseconds||Standard Deviation|Least Squares Mean
2629670|NCT01860703|Primary|Maximum Change From Baseline (dQT/dQTc)|"Maximum Change From Baseline (dQT/dQTc) for deferiprone and placebo.~ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The Cardiodynamic Analysis Set consisted of all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).|||percentage of participants|||Number
2629671|NCT01860703|Primary|Maximum Postdose QT/QTc Interval|"The maximum post-dose QT/QTc interval for deferiprone and placebo.~ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The Cardiodynamic Analysis Set consisted of all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).|||percentage of participants|||Number
2653310|NCT01644240|Primary|AUC0-24|Area under the plasma concentration time curve 24 hours following the last dose.|Day 5||||pg*hr/mL||Standard Deviation|Mean
2629672|NCT01860703|Primary|Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 50 mg/kg Deferiprone|"Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.~ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|Cardiodynamic Analysis Set : all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).|||milliseconds||Standard Deviation|Least Squares Mean
2629673|NCT01860703|Secondary|T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide|"T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers.~Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.|||hour||Standard Deviation|Mean
2629674|NCT01860703|Secondary|AUC0-infinity for Serum Deferiprone and Deferiprone 3-O-glucuronide|"AUC0-infinity was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in healthy volunteers.~Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.|||μg *hr/mL||Standard Deviation|Mean
2629675|NCT01860703|Secondary|Tmax of Deferiprone and Deferiprone 3-O-glucuronide|"To evaluate the Tmax of deferiprone and deferiprone 3-O-glucuronide following administration of single doses of 33 and 50 mg/kg deferiprone in healthy volunteers.~Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.|||hour||Full Range|Median
2629676|NCT01860703|Secondary|Cmax of Deferiprone and Deferiprone 3-O Glucuronide|"To evaluate the Cmax of deferiprone and deferiprone 3-O-glucuronide following administration of single doses of 33 and 50 mg/kg deferiprone in healthy volunteers.~Serial blood samples were collected prior to dosing and within 5 minutes following completion of each scheduled post-dose ECG at Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|The PK population consisted of all subjects who had taken study medication and had at least 1 PK sample collected.|||μg/mL||Standard Deviation|Mean
2629677|NCT01860703|Secondary|Number of Participants With Adverse Events|Number of participants with adverse events following therapeutic and supratherapeutic doses of deferiprone|From administration of the first dose until 7 days +/- 1 day following the final dose|The Safety Analysis Set consisted of all subjects who received at least 1 dose of study medication and had at least 1 safety assessment.|||participants|||Number
2629678|NCT01860703|Primary|Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 33 mg/kg Deferiprone|"Change from baseline in QTcF interval was measured by looking at the post-dose difference in change from baseline in Fridericia's QT corrected heart rate (dQTcF) between treatment and placebo (ddQTcF) at each time interval.~ECG recordings were obtained within a 5-minute time window at Hours -0.75, -0.5, and -0.25 (prior to dosing) and Hours 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, and 24 post-dose."|24-hour interval|Cardiodynamic Analysis Set : all randomized subjects who received at least 1 dose of study medication and who had valid Day 1 QT/QTc interval measurements (predose and at least one postdose measurement).|||milliseconds||Standard Deviation|Least Squares Mean
2629679|NCT01860677|Secondary|Change in Visual Analogue Scale (VAS) in Active Stimulation Arm|"Visual Analogue Scale (VAS) ranges from 0-100. Anchors of not at all (0) to most ever (100) were used to rank the following:~anxious, sleepy, dizzy, relaxed, physical symptoms, confused, sluggish, energetic, fatigued, and stressed. Change compares post-treatment to pre-treatment."|within 30 minutes after 1-day CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment|"Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active Arm only.~3 participants were missing data on these measures."|||units on a scale||Standard Deviation|Mean
2629680|NCT01860677|Secondary|Change in Positive and Negative Affect Schedule (PANAS) in Active Stimulation Arm|"Positive and Negative Affect Schedule (PANAS), as defined by Watson et al. (1988), range between 10 and 50 points. Anchors of not at all (10) to most ever (50) were used to rank each measure. Change compares post-treatment to pre-treatment.~Positive Affects included the following terms: Attentive, Active, Alert, Excited, Enthusiastic, Determined, Inspired, Proud, Interested, and Strong. Negative Affects included the following terms: Hostile, Irritable, Ashamed, Guilty, Distressed, Upset, Scared, Afraid, Jittery, and Nervous. Higher positive affect scores indicated a better outcome, while lower negative affect scores indicated a better outcome."|within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment|Participants in the active stimulation arm. Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active Arm only.|||units on a scale||Standard Deviation|Mean
2629681|NCT01860677|Secondary|BOLD fMRI (Neural Activation Patterns/Brain Function) in Active Stimulation Arm Only|"Quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI from 20 minutes of CES compared to pre-treatment.~The coupling ratio is defined as the percent change in the cerebral blood flow divided by the percent change in the cerebral metabolic rate of oxygen consumption."|within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment|Data were not collected for Sham intervention; Outcome pre-specified to be assessed for Active Arm only|||coupling ratio||Standard Deviation|Mean
2629682|NCT01860677|Primary|BOLD fMRI (Neural Activation Patterns/Brain Function) Among Participants Who Completed Both Active and Sham Stimulation Visits|"Quantitative changes in neural activation patterns during task performance as measured by BOLD functional MRI from 20 minutes of CES compared to pre-treatment.~The coupling ratio is defined as the percent change in the cerebral blood flow divided by the percent change in the cerebral metabolic rate of oxygen consumption."|within 30 minutes after CES treatment concluded; pre-treatment is at least 20 minutes before end of treatment|Data were not collected||||||
2653311|NCT01644240|Primary|t½|Time to 50% plasma concentration|Day 5||||hours||Standard Deviation|Mean
2629686|NCT01860651|Secondary|Surgery|Need for surgery|The first event during participation (2 years). (events were prospecitvely registered)|"In this analysis both participants from study 1 (web 27, control 26) and 2 (web 29, control 21) are represented.~No surgeries were performed, and therefore there is no mean and SD"|||Surgeries||Standard Deviation|Mean
2629687|NCT01860651|Secondary|Number of Participants With Step up in Medical Intensity|"Time to frist step-up in treatment intensity (escalating dose or change/addition of a more potent drug) were obtained from the patient's medical record during the study period, as a proxy of progression in disease activity.~Time to step up was analysed via Kaplan Meier survival analysis."|The first event during participation (2 years). (events were prospecitvely registered)||||Participants|||Count of Participants
2629688|NCT01860651|Primary|Medical Adherence|Participants (group 1, medication adm. at home): Medicine Adherence Report Scale (MARS): range 5-25 points. Higher scores mean a better outcome. In the below Outcome Measure Data Table the mean data for each group (web and control) summarized from the whole study periode are presented.|Prospective, each third month, up to 2 years|Number of participants is only from study 1) Patients in treatment with medicine adminstered at home (participant in the web-group: 27; participant in the control-group: 26)|||units on a scale||95% Confidence Interval|Mean
2629689|NCT01860586|Other Pre-specified|Intravitreal Bevacizumab Injections Impact on Visual Acuity Score (Change in Letters Read).|Increase or decrease in amount of letters read after intravitreal bevacizumab injections versus control patient that did not receive injections of intravitreal bevacizumab.|6 months|Final logMAR visual acuity of patients treated with bevacizumab|||logMAR visual acuity||Standard Deviation|Mean
2629690|NCT01860586|Secondary|The Effect of Intravitreal Bevacizumab Injections on the Development of Epiretinal Membranes (Increase or Decrease)|To determine if intravitreal bevacizumab injections will increase or decrease the occurences (cases) of epiretinal membranes .|6 months|Number of patients treated with bevacizumab who developed epiretinal membrane|||Participants|||Count of Participants
2629691|NCT01860586|Primary|The Effect of Intravitreal Bevacizumab Injections on Rate of Recurrent Retinal Detachment (Increase or Decrease)|This will be assessed by the frequency (occurences) of retinal detachments in patients that have intravitreal bevacizumab injections versus prior patients that did not have intravitreal bevacizumab injections.|up to 6 months|Bevacizumab treated patients with recurrent retinal detachment|||Participants|||Count of Participants
2629692|NCT01860573|Secondary|Serum Blood Urea Nitrogen||Day of life 1, 2, 3, 5 and 7||||mg/dL||Standard Deviation|Mean
2629693|NCT01860573|Secondary|Serum Creatinine||Day of life 1, 2, 3, 5 and 7||||mg/dL||Standard Deviation|Mean
2629694|NCT01860573|Secondary|Serum Bicarbonate||Day of life 1, 2, 3, 5 and 7||||mmol/L||Standard Deviation|Mean
2629695|NCT01860573|Primary|Cognitive Development Score|Reported as units on a scale with mean of 100 and a Standard Deviation of 15, and range from 40-160. Higher values indicate a better outcome.|18-22 months corrected gestational age|Data not available for subjects who died or were lost to follow up.|||units on a scale||Standard Deviation|Mean
2629696|NCT01860573|Primary|Number of Participants With Head Circumference <10th Percentile for Age||36 weeks post-conceptual age|Data not available for subjects who died or were discharged prior to 36 weeks post-conceptual age and some data were missing.|||Participants|||Count of Participants
2629697|NCT01860573|Primary|Number of Participants With Length <10th Percentile for Age||36 weeks post-conceptual age|Data not available for subjects who died or were discharged prior to 36 weeks post-conceptual age, and some data were missing.|||Participants|||Count of Participants
2629698|NCT01860573|Primary|Number of Participants With Weight<10th Percentile for Age||36 weeks post-conceptual age|Data not available for subjects who died or were discharged prior to 36 weeks post-conceptual age|||Participants|||Count of Participants
2629699|NCT01860534|Secondary|Pain|At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Pain scores were recorded by direct observation using the Neonatal and Infant Pain Scale (NIPS). The mean of the five recorded values for each variable was used. NIPS scoring consists of 6 measures associated with neonatal or infant pain, each with a range of 0-7 with low scores (0-2) associated with no pain and scores > to 4 associated with severe pain. Maximum scoring would be 42 for severe pain and minimal being 0 for no pain. The six measures on NIPS include: facial expression, crying, breathing patterns, arm movements, leg movements and state of arousal.|pre-mydriasis, 1 hour and 3 hours after mydriatic drops||||units on a scale||Standard Deviation|Mean
2629700|NCT01860534|Secondary|Oxygen Percent Saturation|At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Oxygen percent saturation was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used|pre-mydriasis, 1 hour and 3 hours after mydriatic drops||||percent saturation||Standard Deviation|Mean
2629701|NCT01860534|Secondary|Respiratory Rate|At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Respiratory rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used|pre-mydriasis, 1 hour and 3 hours after mydriatic drops||||Breaths per minutes||Standard Deviation|Mean
2629702|NCT01860534|Primary|Heart Rate|At 3 times (pre-mydriasis, 1 hour and 3 hours after Cyclomydril drops), subjects were exposed to ambient lighting for a period of five minutes. This usually entailed removing isolette covers and exposing the patient to the ambient room light. During this time, pain and vital signs were recorded every minute. Heart rate was recorded directly from their cardio-respiratory monitor (Agilent M1106C). The mean of the five recorded values for each variable was used|pre-mydriasis, 1 hour and 3 hours after mydriatic drops||||Beats per minutes||Standard Deviation|Mean
2629703|NCT01860521|Secondary|Total Sufentanil Consumption.||During the whole analgesia procedure (assessed between the starting of the procedure until 66 hours).||||microg||Standard Deviation|Mean
2629705|NCT01860521|Secondary|Degree of Satisfaction of the Patients With the Analgesia Procedure|"At discharge from the hospital, patients were requested to answer the following question Taking into consideration the variations in pain symptoms, as well as the adverse events experienced, if any, how would you define the grade of satisfaction with your analgesic treatment? The grade of satisfaction was assessed using a visual analog scale (VAS) where 0 corresponded to completely unsatisfied and 100 to completely satisfied."|At discharge from the hospital (up to 72 hours from starting of the procedure).||||mm||Standard Deviation|Mean
2629706|NCT01860521|Primary|Incidence of Motor Block|The assessment of the degree of motor block was performed in the right and left lower extremities using the Breen modified Bromage score: 1 = complete block (unable to move feet or knees), 2 = almost complete block (able to move feet only), 3 = partial block (just able to move knees), 4 = detectable weakness of hip flexion while supine (between scores 3 and 5), 5 = no detectable weakness of hip flexion while supine (full flexion of knees), and 6 = able to stand and to perform partial knee bend. Patients with a Bromage score < 6 were considered to have motor block.|Assessed every hour from starting the analgesia procedure (up to 66 hours from starting of the procedure).||||participants|||Number
2629707|NCT01860287|Primary|"Subjective Effects as Assessed by Score on Feel Drug, Feel High, Like Drug, and Want More Subscales of the Drug Effects Questionnaire Subjective Responses to Stress With and Without Buprenorphine"|"The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: Feel Drug, Feel High, and Want More. The Feel Drug, Feel High, Like Drug, and Want More subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0 -100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome."|End of study - (Pre-administration of drug or placebo (Time 0), and approx 210 minutes after drug/placebo admin), End of study (210 min) shown||||units on a scale||Standard Deviation|Mean
2629708|NCT01860170|Other Pre-specified|GVHD|"aGVHD onset at a certain grade will be used to calculate the cumulative incidence for that grade (e.g., onset of grade 70 post-transplant , time to grade III is 70 days). This end point will be evaluated through day 150 post-transplant. The diagnosis of aGVHD is based on clinical and pathological evaluation by the treating physician.~The first day of cGVHD will be used to calculate the cumulative incidence of cGVHD. The diagnosis of cGVHD is based on clinical and pathological evaluation by the treating physician."|Assessed routinely by clinical and pathological evaluation. Acute GVHD will be assessed up to day 150 post-transplant. Chronic GVHD will be assess up to 2 years post-transplant.||||participants|||Number
2629709|NCT01860170|Secondary|Engraftment|"Neutrophil engraftment is defined as achieving an absolute neutrophil count (ANC) > 0.5 109/L for 3 consecutive measurements on different days. The first of the 3 days will be considered the day of neutrophil engraftment.~Platelet engraftment is defined as platelet count > 20 109/L for 3 consecutive measurements over at least 3 days. The first of the 3 days will be considered the day of platelet engraftment.~In this study, graft failure is defined as lack of achieving neutrophil engraftment by day 22 and donor chimerism > 50% by day 45."|Assessed daily by laboratory evaluation until engraftment or up to 90 days.||||Participants|||Count of Participants
2629710|NCT01860170|Primary|Dose Limiting Toxicity|Grade 3 non-hematologic Common Toxicity Criteria toxicity directly related to bortezomib (such as peripheral neuropathy) or Grade 2 or > hepatic bilirubin Common Toxicity Criteria Graft failure|Assessed daily (while inpatient) through clinical and laboratory examination up to 90 days.||||Participants|||Count of Participants
2629711|NCT01860079|Primary|All Cause Mortality and Readmission at 30 Days.|The primary end points were all cause mortality by 1 month and readmission due to reinfarction, unstable angina, arrhythmia, congestive heart failure, revascularization, stroke or major bleeding at 1 month.|30 DAYS||||participants|||Number
2629712|NCT01860040|Primary|Rate of Pathologic Complete Responses (pCR) at the Time of Definitive Surgical Resection of Non-small Cell Lung Cancer|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic Resonance Imagery (MRI): Complete Response (CR), Disappearance of all target lesions|One year|There are no data recordings for this study. The study was terminated and the investigator is no longer related to the site. There is no additional information to provide.||||||
2629713|NCT01859988|Secondary|Changes in GISS Cumulative Score From Baseline to Week 16|Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0 = none,1 = mild, 2 = moderate and 3 = severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with GISS score assessment at specified time-points. Missing values imputed by LOCF.|||units on a scale||Standard Error|Least Squares Mean
2629714|NCT01859988|Secondary|Changes in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) From Baseline to Week 16|Individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) were rated globally (each assessed for the whole body, not by anatomical region) on a 4-point scale (0=none, 1=mild, 2=moderate and 3=severe) using the EASI severity grading criteria. Total score ranges from 0 (absent disease) to 12 (severe disease).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with GISS score assessment at specified time-points. Missing values imputed by LOCF.|||units on a scale||Standard Error|Least Squares Mean
2629715|NCT01859988|Secondary|Absolute Change in POEM Scores From Baseline to Week 16|POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with POEM score assessment at specified time-points. Missing values imputed by LOCF.|||units on a scale||Standard Error|Least Squares Mean
2629752|NCT01859598|Primary|the Change of Hypoglycemia During Follow-up.|•The rate of hypoglycemia at baseline, 3 months (visit 2) and 6 months (visit 3)|baseline and 6 months|The population at visit 3 were used to analyze the hypoglycemia and weight change from visit 1 to visit 3|||percentage of patients with hypoglycemia|||Number
2653312|NCT01644240|Primary|Tmax|Time to reach maximum plasma concentration.|Day 5||||hours||Full Range|Median
2629716|NCT01859988|Secondary|Percent Change in Patient Oriented Eczema Measure (POEM) Scores From Baseline to Week 16|POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease) (high score indicative of poor quality of life [QOL]).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with POEM score assessment at specified time-points. Missing values imputed by LOCF.|||Percent change||Standard Error|Least Squares Mean
2629717|NCT01859988|Secondary|Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in SCORAD Score (SCORAD-50, SCORAD-75 and SCORAD-90 Respectively) at Week 16|SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). SCORAD-50, SCORAD-75 and SCORAD-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% overall improvement in SCORAD score respectively from baseline to Week 16.|Week 16|Analysis was performed on FAS. Participants with a missing SCORAD score at Week 16 were treated as non-responders.|||Percentage of participants||95% Confidence Interval|Number
2629718|NCT01859988|Secondary|Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in EASI Score (EASI-50, EASI-75 and EASI-90 Respectively) at Week 16|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50, EASI-75 and EASI-90 responders were the participants who achieved ≥50%, ≥75% and ≥90% overall improvement in EASI score respectively from baseline to Week 16.|Week 16|Analysis was performed on FAS. Participants with a missing EASI score at Week 16 were treated as non-responders.|||Percentage of participants||95% Confidence Interval|Number
2629719|NCT01859988|Secondary|Absolute Change in SCORAD Scores From Baseline to Week 16|SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with SCORAD score assessment at specified time-points. Missing values imputed by LOCF.|||units on a scale||Standard Error|Least Squares Mean
2629720|NCT01859988|Secondary|Percent Change in SCORing Atopic Dermatitis (SCORAD) Scores From Baseline to Week 16|SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with SCORAD score assessment at specified time-points. Missing values imputed by LOCF.|||Percent change||Standard Error|Least Squares Mean
2629721|NCT01859988|Secondary|Absolute Change in EASI Score From Baseline to Week 16|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with EASI score assessment at specified time-points. Efficacy data was set to missing after use of rescue medication. Missing values imputed by LOCF.|||Units on a scale||Standard Error|Least Squares Mean
2629722|NCT01859988|Secondary|Absolute Change in Peak Weekly Averaged Pruritus NRS From Baseline to Week 16|Pruritus NRS is an assessment tool that is used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed =participants with pruritus NRS assessment at specified time-points. Efficacy data was set to missing after use of rescue medication. Missing values imputed by LOCF.|||units on a scale||Standard Deviation|Mean
2629723|NCT01859988|Secondary|Percent Change in Peak Weekly Averaged Pruritus Numerical Rating Scores (NRS) From Baseline to Week 16|Pruritus NRS is an assessment tool that is used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline to Week 16|Analysis was performed on FAS. Here, number of participants analyzed = participants with pruritus NRS assessment at specified time-point. Efficacy data was set to missing after use of rescue medication. Missing values imputed by LOCF.|||Percent change||Standard Deviation|Mean
2629724|NCT01859988|Secondary|Percentage of Participants Who Achieved IGA Score Reduction of ≥2 at Week 16|IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic success is an IGA score of 0 (clear) or 1 (almost clear). Participants with IGA score reduction from baseline of ≥2 points at Week 16 were reported. Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as a non-responders.|Week 16|Analysis was performed on FAS.|||Percentage of participants||95% Confidence Interval|Number
2629753|NCT01859598|Primary|To Assess the Change in HbA1c During the 6 Months Follow-up.|• Change of HbA1c from baseline to the end-point (6 month).|Baseline and 6 months|the patients who have the results of HbA1c|||percent||Standard Deviation|Mean
2653313|NCT01644240|Secondary|Number of Subjects With Adverse Events||1 week||||participants|||Number
2629725|NCT01859988|Secondary|Percentage of Participants Who Achieved Investigator's Global Assessment (IGA) Response at Week 16|IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a static 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). Values after first rescue medication were set to missing and participants with missing IGA score at Week 16 were treated as a non-responders.|Week 16|Analysis was performed on FAS.|||Percentage of participants||95% Confidence Interval|Number
2629726|NCT01859988|Primary|Percent Change in Eczema Area and Severity Index Score (EASI) From Baseline to Week 16|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.|Baseline to Week 16|Full analysis set (FAS) that included all randomized participants who received at least 1 dose of study drug. Here, number of participants analyzed = participants with EASI score assessment at specified time-point. Efficacy data was set to missing after use of rescue medication. Missing values imputed by last observation carried forward (LOCF).|||Percent change||Standard Deviation|Least Squares Mean
2629727|NCT01859949|Secondary|Height SDS for Bone Age|"To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children.~Height SDS for bone age is calculated as following formula; Height SDS = (height - mean) / standard deviation,~where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender.~The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender."|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.|||SDS||Standard Deviation|Mean
2629728|NCT01859949|Secondary|Height Velocity SDS for Bone Age|"To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children.~Height velocity is the yearly height gain. Height velocity SDS for bone age is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation,~where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender.~The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender."|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.|||SDS||Standard Deviation|Mean
2629729|NCT01859949|Secondary|Height SDS for Chronological Age|"Height SDS is calculated as following formula; Height SDS = (height - mean) / standard deviation,~where mean and standard deviation were based on standard Japanese values on the participant age and gender.~The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender."|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.|||SDS||Standard Deviation|Mean
2629730|NCT01859949|Secondary|Height Velocity|Height velocity is the yearly height gain|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.|||cm/year||Standard Deviation|Mean
2629731|NCT01859949|Secondary|Height Velocity Standard Deviation Score (SDS) for Chronological Age|"Height velocity is the yearly height gain. Height velocity SDS is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation,~where mean and standard deviation were based on standard Japanese values of the participants age and gender.~The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender."|Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.|||SDS||Standard Deviation|Mean
2629732|NCT01859949|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)||Month 12 (at the end of previous study) to 156|Full Analysis Set (FAS) included participants who received at least 1 dose of study medication and had at least one observation after enrollment of this study.|||participant|||Number
2629733|NCT01859793|Secondary|Circulating Inflammatory Markers VCAM-1||Change before and after acute dose (2 hours) and 8 weeks after daily dosing of medication|29 of the 30 subject who completed the study. Once subject had missing data for the post-8 weeks of each intervention|||mg/mL||Standard Deviation|Mean
2629734|NCT01859793|Secondary|Circulating Inflammatory Marker ICAM-1||Change before and after acute dose (2 hours) and 8 weeks after daily dosing of medication|29 of the 30 subjects who completed both arms of the study. One subject was missing the measurements post 8 weeks of each intervention arm and was excluded|||mg/mL||Standard Deviation|Mean
2629735|NCT01859793|Primary|Brachial Artery Flow Mediated Dilation|A measurement of endothelial function in humans|Change before and after a single dose (2 hours post) and 8 weeks after daily dosing|All 30 subjects who completed both arms of the cross-over study|||%FMD||Standard Deviation|Mean
2629736|NCT01859741|Primary|Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population)|The response rate is the number of subjects per treatment arm who have either a complete response (CR) or partial response (PR) for best overall response (according to RECIST criteria) divided by the number of subjects randomized to the respective arms.|Up to 1 year in absence of unacceptable toxicity or disease progression||||Participants|||Count of Participants
2629737|NCT01859741|Primary|Phase 2: Progression Free Survival (ITT Population)|To determine the improvement in Progression Free Survival (PFS) resulting from the addition of tarextumab to etoposide and platinum therapy (EP) in subjects receiving first-line therapy for extensive stage small cell lung cancer. PFS is based on the Investigator-assessments of tumor response which is defined as the number of days from randomization until death or disease progression as defined by RECIST criteria for the ITT Population.|Up to 1 year until disease progression or death.||||Participants|||Count of Participants
2632474|NCT01834586|Secondary|Average Pain Rating|Average Pain Rating over 24-hours, defined as the average injection-site pain over 24-hours on a 0-10 VAS (0 = no pain, 10 = worst pain).|baseline and two weeks||||units on a scale||Standard Deviation|Mean
2629738|NCT01859741|Primary|Phase 1b: Overall Response (Response Evaluable Population)|The best overall response is defined as the best Investigator-assessed response recorded from the start of the treatment until disease progression in the following order of importance: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Evaluable (NE). Response evaluable population includes subjects who received 1 partial dose of OMP-59R5 and at at least 1 post tumor assessment.|Up to 1 year in absence of unacceptable toxicity or disease progression.||||Participants|||Count of Participants
2629739|NCT01859741|Primary|Phase 1b: To Determine the Maximum Tolerated Dose (MTD) of OMP-59R5 When Administered With Etoposide and Cisplatin or Carboplatin (Number of Subjects With DLTs)|To determine the MTD of tarextumab when administered on Day 1 of each 21 day cycle along with etoposide 100 mg/m2 on Days 1, 2 and 3, and cisplatin 80 mg/m2 or carboplatin area under the curve (AUC) of 5 mg/mL•min on Day 1 in subjects with untreated extensive stage small cell lung cancer. DLT evaluable population includes all subjects who received at least 1 partial dose of OMP-59R5 during the Phase 1b dose escalation portion of the study including the carboplatin cohort and who had completed Day 21 cycle of 1 OMP-59R5 administration or had discontinued due to drug-related toxicity.|Up to 1 year in absence of unacceptable toxicity or disease progression.|The MTD of OMP-59R5 in combination with etoposide and cisplatin or carboplatin was not reached and the recommended phase 2 dose was determined to be 15 mg/kg every 21-day cycle.|||Participants|||Count of Participants
2629740|NCT01859715|Secondary|Adverse Drug Events|Determine all possible adverse drug events that occurred after the study drugs were administered.|Duration of ED stay, <24 hours. (up to 24 hours)||||participants|||Number
2629741|NCT01859715|Primary|Difference in Clinically Significant Visual Analogue Scale for Pain and Nausea Change Between CYP2D6 Users and Non-users|Clinically significant visual analogue scale (VAS; a measure of adult pain and nausea on a scale of 1-100 millimeters for increasing symptoms of pain and nausea) for patients who were administered either oxycodone, hydrocodone/acetaminophen, or ondansetron in the ED. Clinically significant change was defined as 13mm change on the VAS from baseline (when first VAS was completed) to 90 minutes following drug administration in the ED.|Baseline and 90 minutes||||millimeters||95% Confidence Interval|Mean
2629742|NCT01859702|Primary|Mean Aqueous Humor Concentration of Moxifloxacin|A 0.150 milliliter sample of the aqueous humor was obtained during cataract surgery. The concentration of moxifloxacin was measured by a validated procedure using high performance liquid-spectrometry.|Day 3 (operative day)|Per protocol: All subjects who met inclusion/exclusion criteria, received all doses of the test product, and underwent cataract surgery with aqueous humor sampling.|||nanograms per milliliter||95% Confidence Interval|Mean
2629743|NCT01859637|Secondary|Change in Absolute Neutrophile Count (ANC)|"To evaluate the efficacy of Zarzio®/Filgrastim HEXAL® in patients with SCN in terms of changes in absolute neutrophile count (ANC).~Change from each visit to baseline in ANC for all patients is calculated."|Participants were followed for a duration of 12 months and ANC was assessed at baseline, week 6, Month 3, Month 6, Month 9 and Month 12.|Safety population (SAF): all patients with at least one dose Zarzio®/Filgrastim HEXAL® and at least one post-baseline safety assessment|||10^9 cells/L||Full Range|Median
2629744|NCT01859637|Secondary|Number of Participants With Adverse Events (AEs)|Patients experiencing AEs by system organ class and preferred term (PT) and number of events. Patients with more than one AE coded to the same PT were counted once per PT|12 months|Safety population (SAF): all patients with at least one dose Zarzio®/Filgrastim HEXAL® and at least one post-baseline safety assessment|||participants|||Number
2629745|NCT01859637|Primary|Incidence of Anti- Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) Antibodies|"Incidence of anti-rhG-CSF antibodies was monitored. Patients were screened for anti-rhG-CSF antibodies at screening and at each study except visit 02 (start of treatment = baseline).~Evaluation of immune response to rhG-CSF administration was made by a three-step procedure comprising a validated binding antibody screening and confirmatory radioimmunoprecipitation assay (RIP) and a validated cell-based neutralization antibody assay (NAB)."|screening, 3, 6, 9 and 12 months|Safety population (SAF): All patients with at least one dose Zarzio®/Filgrastim HEXAL® and at least one post-baseline safety assessment. All six patients were screened for anti-rhG-CSF antibodies at all six study visits, except for one missing assessment (no sample was taken for patient 0204 at Visit 03, which was an optional visit).|||participants|||Number
2629746|NCT01859611|Secondary|Adverse Events.|At every treatment and follow-up visit the treated areas will be examined to evaluate side effects and adverse reactions remaining from the previous treatment session or occurring since then.|Subjects will be followed for the duration of the study, and expected average of 20 weeks|||||||
2629747|NCT01859611|Secondary|Patient Satisfaction and Comfort of the Treatment.|At each of the specified time points, subjects will complete a Subject Evaluation Form assessing their opinion of improvement and overall satisfaction with treatment.|Pre Treatment 5, 1 Week FU, 1 Month FU, 3 Month FU|||||||
2629748|NCT01859611|Primary|Changes to the Surface by Visual and Photographic Analysis.|"At each of the specified time points, photographs of the treated areas will be taken. The photography angles will include a global frontal photo and the right and left sides of the face at 45° and/or 90°. In addition, close up photos will be taken of specific facial zones, e.g., the peri-orbital wrinkles.~Each patient to be evaluated through the 9 grade Fitzpatrick Wrinkling Severity Scale.~Wrinkling Score Degree of Elastosis Fine 1-3 Mild Fine to moderate 4-6 Moderate Fine to deep wrinkles 7-9 Severe"|3 Month FU|Number of participants with observed changes (grade of improvement ≥ 1) to the surface of the skin based on photographic analysis at 3 Month FU|||participants|||Number
2629749|NCT01859598|Secondary|Overall Weight Gain From Visit 1 to Visit 3|the weight gain= the mean weight at visit1 - the mean weight at visit 3|baseline and 6 months|Patients at visit 3 were used for analyzing the change of weight|||Kg||Standard Deviation|Mean
2629750|NCT01859598|Secondary|the FPG Control Rate at Visit 3|the percentage of patients who had the FPG level <7.0 mmol/L at visit 3|6 months|At visit 3, the patients who self-reported their FPG level were used for analysis|||percentage of patients with FPG<7.0|||Number
2629751|NCT01859598|Secondary|the FPG Change From Visit 1 to Visit 3|the FPG change = the FPG level at visit 1- the FPG level at visit 3|baseline and 6 months|the population in the visit 3 were used for analysis|||mmol/L||Standard Deviation|Mean
2632188|NCT01838304|Secondary|Procedure Time|Time from endoscopic intubation until completion of the procedure. This is not really an outcome measure, but is used to assess balance between groups.|Procedure time (average of 9 minutes)||||minutes||Standard Deviation|Mean
2629754|NCT01859507|Secondary|Successful Sexual Relationship|The level of comfort by the couple. The secondary outcome will be assessed by the couple. The couple is allowed to visit for follow up every three months for twelve months. Our inquiry is on the success of full and repeated penetration of the penis through the vaginal introitus into the vagina without or with acceptable pain. An acceptable outcome will be at least twice weekly successful sexual relationship that was completedwithout premature interruption from either partners.|Within twelve months after the Botox injection||||participants|||Number
2629755|NCT01859507|Primary|Success of Repeated Penetration of the Penis Through the Vaginal Introitus Into the Vagina Without or With Acceptable Pain|The primary outcome will be assessed by the couple. The couple is allowed to visit for follow up in a 4 weeks' time. Our inquiry is on the success of full and repeated penetration of the penis through the vaginal introitus into the vagina without or with acceptable pain. An acceptable outcome will be at least twice weekly successful sexual relationship that was completed without premature interruption from either partners.|Up to four weeks following the last session of the vaginal dilatation.|multiple penetration with minimal pain as informed by the couple during their follow up sessions 4 weeks after the completion of the dilatation sessions|||participants|||Number
2629756|NCT01859494|Secondary|Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements|Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'.|1 hour|218 (219-1) responses were analyzed. One subject discontinued from testing after low BG result (hypoglycemia Adverse Event).|||Participant Responses|||Number
2629757|NCT01859494|Secondary|Number of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method When Tested by Study Staff|Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma)|1 hour|218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG result (hypoglycemia AE), thus no reference result available for that subject.|||Blood Glucose results within 15mg/dL/20%|||Number
2629758|NCT01859494|Secondary|Number of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results were used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma)|1 hour|211 (219-8) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia Adverse Event. Three subjects with low blood sugar did not attempt palm testing per protocol. Two subjects had low blood sugar; their palm results were not evaluable per protocol. Two subjects failed to obtain palm blood for testing.|||Blood Glucose results within 15mg/dL/20%|||Number
2629759|NCT01859494|Secondary|Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 12.5mg/dL (<100mg/L YSI) or Within +/- 12.5% (>=100mg/dL YSI) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI BG results were used to calculate the number of BGMS results within +/- 12.5mg/dL (<100mg/dL YSI capillary plasma) or +/- 12.5% (>=100mg/dL YSI capillary plasma)|1 hour|218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available for that subject.|||Bld Glucose results w/in 12.5mg/dL/12.5%|||Number
2629760|NCT01859494|Secondary|Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 15mg/dL (<100mg/L YSI) or Within +/- 15% (>=100mg/dL YSI) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI BG results were used to calculate the number of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma)|1 hour|218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available for that subject.|||Blood Glucose results within 15mg/dL/15%|||Number
2629761|NCT01859494|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL (<75mg/dL) or Within +/-20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma).|1 hour|218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low Blood Glucose (BG) fingerstick result (hypoglycemia AE), thus no reference result available for that subject.|||Blood Glucose results within 15mg/dL/20%|||Number
2629762|NCT01859390|Secondary|Number of Participants Hospitalized|Number (%) of participants with at least one hospitalization between Baseline (Visit 2) and end of follow up (Week 18).|Baseline (Visit 2) to end of followup (Week 18)||||Participants|||Count of Participants
2629763|NCT01859390|Secondary|Number of Participants With Pulmonary Exacerbations|Number (%) with at least one protocol-defined PEx between baseline (Visit 2) and end of follow up (Week 18).|Baseline (Visit 2) to end of follow up (Week 18)||||Participants|||Count of Participants
2629764|NCT01859390|Secondary|Number of Pulmonary Exacerbations|The total number of PEx between baseline (Visit 2) and end of follow up (Week 18).|Baseline (Visit 2) to end of follow up (Week 18)||||Pulmonary Exacerbations|||Number
2629765|NCT01859390|Secondary|Time to First Pulmonary Exacerbation|Median time to first pulmonary exacerbation (PEx) between baseline (Visit 2) and end of follow up (Week 18)|Baseline (Visit 2) to end of follow up (Week 18)||||days||95% Confidence Interval|Median
2629766|NCT01859390|Secondary|Change in Growth Endpoints|Absolute change in Body Mass Index (BMI) (kg/m^2) between Baseline and Week 16.|Baseline (Visit 2) to Week 16|This population includes participants who did not complete the study (i.e., did not have a final analyzable sputum sample) but did have final height and weight assessments.|||kg/m^2||Standard Deviation|Mean
2629767|NCT01859390|Secondary|Change in Lung Function|Absolute Change in Forced Expiratory Volume over one second (FEV1) % predicted between Baseline and Week 16. Global Lung Initiative equations were used to calculate FEV1 %predicted.|Baseline (Visit 2) to Week 16|This population includes participants who did not complete the study (i.e., did not have a final analyzable sputum sample) but did have a final lung function assessment.|||FEV1 %Predicted||Standard Deviation|Mean
2629768|NCT01859390|Secondary|Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)|Rate is defined as the number of events per participant follow-up week.|18 weeks follow up||||events per participant-week|||Number
2629769|NCT01859390|Secondary|Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)|Incidence is defined as the number and percentage of participants with at least one event over the 18 week follow-up period.|18 weeks follow up||||Participants|||Count of Participants
2629770|NCT01859390|Primary|Change in Sputum Myeloperoxidase (MPO) Level|The primary outcome is the difference in 16 week mean change in log10 sputum myeloperoxidase levels between the AquADEKs-2 arm and the Control Multivitamin arm.|Baseline (Visit 2) to Week 16 (Visit 4)||||log10 (ng/mL)||Standard Deviation|Mean
2629771|NCT01859325|Secondary|HIV-1 Viral Load Following Antiretroviral Treatment Interruption (ATI).|The difference in HIV-1 viral load at the end of the ATI between the vaccine and placebo groups. Levels of plasma viremia in the vaccine and placebo groups were compared using the Wilcoxon rank sum test at the end of treatment interruption periods to determine the antiviral efficacy of the therapeutic vaccine regimen. The limit of detection of plasma viremia was 40 copies/ml of HIV RNA.|72 weeks|All subjects who received vaccine or placebo|||copies/ml||Inter-Quartile Range|Median
2629772|NCT01859325|Primary|The Rate of Related Adverse Events in Subjects Who Began cART During Acute or Early HIV-1 Infection.|"The rate of occurrence of grade 3 or higher AEs, including serious adverse events (SAEs) that per standard criteria (see safety section) are:~At least possibly related to the test article, and Definitely NOT related to a factor other than the test article This is to evaluate safety and tolerability of the study vaccines."|48 weeks|All subjects who received vaccine or placebo|||Related Adverse Events|||Number
2629773|NCT01859312|Secondary|Participant Lean Body Mass|lean body mass measured by DEXA, Hologic Discovery-A|At 6 months||||kg||Standard Error|Mean
2629774|NCT01859312|Secondary|Participant Lean Body Mass|lean body mass measured by DEXA, Hologic Discovery-A|At baseline||||kg||Standard Error|Mean
2629775|NCT01859312|Secondary|Participants Mean Level of Progesterone Area Under the Curve (AUC) - Nighttime (2300 - 0700)|Participants Mean Level of Progesterone area under the curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*ng/dL||Standard Error|Mean
2629776|NCT01859312|Secondary|Participants Mean Level of Progesterone Area Under the Curve (AUC) - Nighttime (2300 - 0700)|Participants Mean Level of Progesterone area under the curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*ng/dL||Standard Error|Mean
2629777|NCT01859312|Secondary|Participants Mean Level of Progesterone Area Under the Curve (AUC) - Midday (1500 - 2300)|Participants Mean Level of Progesterone area under the curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*ng/dL||Standard Error|Mean
2629778|NCT01859312|Secondary|Participants Mean Level of Progesterone Area Under the Curve (AUC) - Midday (1500 - 2300)|Participants Mean Level of Progesterone area under the curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*ng/dL||Standard Error|Mean
2629779|NCT01859312|Secondary|Participants Mean Level of Progesterone Area Under the Curve (AUC) - Daytime (0700-1500)|Participants Mean Level of Progesterone area under the curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*ng/dL||Standard Error|Mean
2629780|NCT01859312|Secondary|Participants Mean Level of Progesterone Area Under the Curve (AUC) - Daytime (0700-1500)|Participants Mean Level of Progesterone area under the curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*ng/dL||Standard Error|Mean
2629781|NCT01859312|Secondary|Participants Mean Level of Progesterone Area Under the Curve (AUC) - 24 Hours|Participants Mean Level of Progesterone area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*ng/dL||Standard Error|Mean
2629826|NCT01859143|Primary|Percentage of Participants With Fever Greater Than or Equal to (>=) 101 Degrees Fahrenheit (F)|Percentage of participants with fever defined as oral temperature >=101 degrees F were reported.|Within 7 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.|||percentage of participants|||Number
2629782|NCT01859312|Secondary|Participants Mean Level of Progesterone Area Under the Curve (AUC) - 24 Hours|Participants Mean Level of Progesterone area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*ng/dL||Standard Error|Mean
2629783|NCT01859312|Secondary|Participants Mean Progesterone Level at 0700|Participants Mean Level of Progesterone at 0700|At 6 months||||ng/mL||Standard Error|Mean
2629784|NCT01859312|Secondary|Participants Mean Progesterone Levels at 0700|Participants Mean Level of Progesterone at 0700|At baseline||||ng/mL||Standard Error|Mean
2629785|NCT01859312|Secondary|Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700)|Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*pg/mL||Standard Error|Mean
2629786|NCT01859312|Secondary|Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700)|Participants Mean Level of ACTH Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*pg/mL||Standard Error|Mean
2629787|NCT01859312|Secondary|Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300)|Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*pg/mL||Standard Error|Mean
2629788|NCT01859312|Secondary|Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300)|Participants Mean Level of ACTH Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*pg/mL||Standard Error|Mean
2629789|NCT01859312|Secondary|Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500)|Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*pg/mL||Standard Error|Mean
2629790|NCT01859312|Secondary|Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500)|Participants Mean Level of ACTH Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*pg/mL||Standard Error|Mean
2629791|NCT01859312|Secondary|Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours|Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*pg/mL||Standard Error|Mean
2629792|NCT01859312|Secondary|Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours|Participants Mean Level of ACTH Area Under the Curve (AUC) - 24 Hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300.Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*pg/mL||Standard Error|Mean
2629793|NCT01859312|Secondary|Participants Mean Level of ACTH at 0700|Participants Mean Level of ACTH at 0700.|At 6 months||||pg/mL||Standard Error|Mean
2629794|NCT01859312|Secondary|Participants Mean Level of ACTH at 0700|Participants Mean Level of ACTH at 0700.|At baseline||||pg/mL||Standard Error|Mean
2629795|NCT01859312|Secondary|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700)|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*mcg/dL||Standard Error|Mean
2629796|NCT01859312|Secondary|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700)|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Nighttime (2300 - 0700). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*mcg/dL||Standard Error|Mean
2629797|NCT01859312|Secondary|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300)|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*mcg/dL||Standard Error|Mean
2632189|NCT01838304|Secondary|Time Spent Below a Saturation of 80%|Number of seconds spent below saturation of 80%, reported as the total per group|Duration of sedation (mean 25 minutes)||||seconds|seconds||Count of Units
2629798|NCT01859312|Secondary|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300)|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Midday (1500 - 2300). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*mcg/dL||Standard Error|Mean
2629799|NCT01859312|Secondary|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500)|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*mcg/dL||Standard Error|Mean
2629800|NCT01859312|Secondary|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500)|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - Daytime (0700-1500). AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*mcg/dL||Standard Error|Mean
2629801|NCT01859312|Secondary|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 Hours|Participants Mean Level of Androstenedione area under the curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*mcg/dL||Standard Error|Mean
2629802|NCT01859312|Secondary|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 Hours|Participants Mean Level of Androstenedione Area Under the Curve (AUC) - 24 hours. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*mcg/dL||Standard Error|Mean
2629803|NCT01859312|Secondary|Participants Mean Level of Androstenedione at 0700|Participants Mean Level of Androstenedione at 0700.|At 6 months||||ng/dL||Standard Error|Mean
2629804|NCT01859312|Secondary|Participants Mean Level of Androstenedione at 0700|Participants Mean Level of Androstenedione at 0700.|At baseline||||ng/dL||Standard Error|Mean
2629805|NCT01859312|Secondary|Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Nighttime (2300 - 0700)|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*mcg/dL||Standard Error|Mean
2629806|NCT01859312|Secondary|Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Nighttime (2300 - 0700)|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour nighttime level, samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*mcg/dL||Standard Error|Mean
2629807|NCT01859312|Secondary|Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Midday (1500 - 2300)|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*mcg/dL||Standard Error|Mean
2629808|NCT01859312|Secondary|Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Midday (1500 - 2300)|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficienc. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour midday level, samples were obtained every 2 hours beginning at 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*mcg/dL||Standard Error|Mean
2629809|NCT01859312|Secondary|Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Daytime (0700-1500)|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*mcg/dL||Standard Error|Mean
2629810|NCT01859312|Secondary|Participants Mean Level of 17-OHP Area Under the Curve (AUC) - Daytime (0700-1500)|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the 8 hour daytime level, samples were obtained every 2 hours beginning at 0700, 0900, 1100, 1300, 1500. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*mcg/dL||Standard Error|Mean
2629811|NCT01859312|Secondary|Participants Mean Level of 17-OHP Area Under the Curve (AUC) - 24 Hours|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At 6 months||||h*mcg/dL||Standard Error|Mean
2653314|NCT01644240|Primary|Cmax|Maximum plasma concentration|Day 5||||pg/mL||Standard Deviation|Mean
2629812|NCT01859312|Secondary|Participants Mean Level of 17-OHP Area Under the Curve (AUC) - 24 Hours|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. AUC was calculated using the linear-up log-down trapezoidal rule for the entire 24 hours and samples were obtained every 2 hours beginning at 2300, 0100, 0300, 0500, 0700, 0900, 1100, 1300, 1500, 1700, 1900, 2100, 2300. Actual collection times were used to define peak plasma concentration (Cmax) and time to peak plasma concentration (Tmax).|At baseline||||h*mcg/dL||Standard Error|Mean
2629813|NCT01859312|Secondary|Participants Mean Level of 17-OHP at 0700|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency|At 6 months||||ng/dL||Standard Error|Mean
2629814|NCT01859312|Secondary|Participants Mean Level of 17-OHP at 0700|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency|At baseline||||ng/dL||Standard Error|Mean
2629815|NCT01859312|Primary|Number of Patients With 17-OH Progesterone Levels Equal or Below 1,200 ng/dL at 0700|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency|At 6 months||||Participants|||Count of Participants
2629816|NCT01859312|Primary|Number of Patients With 17-OHP Levels Equal or Below 1,200 ng/dL at 0700|17-OHP (17-hydroxyprogesterone) is a laboratory blood test to test for congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency|At baseline||||Participants|||Count of Participants
2629817|NCT01859247|Secondary|Composite Measure of Patient Rating of Symptoms and Tolerability|"This measure will confirm the intervention tolerability by the patient. He/she scored the tolerability from 0-10, 0 being completely tolerable and 10 completely intolerable."|Assessment completed immediately after rTMS treatment session||||units on a scale||Standard Deviation|Mean
2629818|NCT01859247|Secondary|Dorsal Premotor-motor Inhibition (dPMI)||Change from baseline dPMI to post-intervention within 1 hour of treatment|two subjects did not have dPMI measured|||percentage||Standard Deviation|Mean
2629819|NCT01859247|Primary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was used to assess severity of disease. The score for this section ranges from 0 (absence of severity) to 35 (maximum severity).|Change from baseline pre-intervention TWSTRS score to post-intervention within 1 hour of treatment||||units on a scale||Standard Deviation|Mean
2629820|NCT01859195|Other Pre-specified|Number of Participants: Drug Delivery Systems Evaluations|Members of focus groups evaluated various drug delivery system designs, to determine final design to move forward with in development|1 year||||Participants|||Count of Participants
2629821|NCT01859195|Primary|Number of Participants: Comprehension of Study Product|"Focus groups captured participant understandings (in narrative form) of plant-produced monoclonal antibodies, how they come about, how they are manufactured, how they differ from other anti-HIV actives, etc. Participant-derived language informed development of study materials, including study product instruction sheets and informed consent materials and documents.~Cognitive Interview assessed Participant comprehension of language used in insertion instruction materials, and monoclonal antibody education and informed consent materials."|1 year||||Participants|||Count of Participants
2629822|NCT01859143|Secondary|Percentage of Participants Who Required Antipyretic and/or Analgesic Medication||Within 7 and 14 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.|||percentage of participants|||Number
2629823|NCT01859143|Secondary|Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) and New Onset Chronic Diseases (NOCDs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent SAEs were serious events between administration of study drug and up to 180 days after the dose that were absent before treatment or that worsen relative to pretreatment state. An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Results are given for TESAEs and NOCDs reported within 28 days and 180 days after vaccination.|Within 28 and 180 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.|||participants|||Number
2629824|NCT01859143|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were events between administration of study drug and up to 14 days after vaccination that were absent before treatment or that worsened relative to pre-treatment state. Results are given for AEs reported within 7 days and 14 days after vaccination.|Within 7 and 14 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.|||participants|||Number
2629825|NCT01859143|Secondary|Percentage of Participants With Solicited Symptoms|Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily after vaccine administration up to 14 days after vaccination. The solicited symptoms included fever greater than (>) 100.0 degrees F (37.8 degrees Celsius), runny nose, sore throat, cough, vomiting, muscle aches, chills, decreased activity and headache. Results are reported for all solicited symptoms except fever >=101 degrees F (reported as primary outcome) within 7 days after vaccination and all solicited symptoms within 14 days after vaccination.|Within 7 and 14 days after vaccination|Safety population included all participants who received any amount of investigational drug and had safety data available. Participants were included in the safety population according to the investigational drug received.|||percentage of participants|||Number
2630371|NCT01854658|Secondary|Onset of Action as Assessed by FEV1|Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant|Day 1|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.|||Liters||95% Confidence Interval|Least Squares Mean
2629827|NCT01859078|Secondary|PK: Renal Clearance (CLr) of Digoxin|CLr is the volume of plasma from which study drug is completely removed by the kidney in a given time and is calculated as Aeτ divided by AUCτ.|Predose to 24 hours post-dose on Days 7 and 16|All enrolled participants who received study drug and had PK data to calculate CLr. Participants were analyzed based on the treatment they received.|||Liters/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2629828|NCT01859078|Secondary|PK: Amount of Drug Excreted Unchanged During 1 Dosing Interval (Aeτ) of Digoxin||0 to 24 hours post-dose on Days 7 and 16|All enrolled participants who received study drug and had PK data to calculate Aeτ. Participants were analyzed based on the treatment they received.|||milligrams (mg)||Geometric Coefficient of Variation|Geometric Mean
2629829|NCT01859078|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin||Predose up to 24 hours post-dose on Days 7 and 16|All enrolled participants who received study drug and had PK data to calculate tmax. Participants were analyzed based on the treatment they received.|||hours (h)||Full Range|Median
2629830|NCT01859078|Primary|PK: Maximum Concentration (Cmax) of Digoxin||Predose up to 24 hours post-dose on Days 7 and 16|All enrolled participants who received study drug and had PK data to calculate Cmax. Participants were analyzed based on the treatment they received.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2629831|NCT01859078|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) of Digoxin||Predose up to 24 hours post-dose on Days 7 and 16|All enrolled participants who received study drug and had PK data to calculate AUCτ. Participants were analyzed based on the treatment they received.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2629832|NCT01859013|Primary|Percent Change From Baseline in Body Mass Index at 28-Weeks|The Percent Change from Baseline in Body Mass Index at 28-Weeks|Baseline and 28-Weeks||||% change BMI||Standard Deviation|Mean
2629833|NCT01858766|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as:~On-treatment virologic failure:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse:~Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2629834|NCT01858766|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2629835|NCT01858766|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
2629836|NCT01858766|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants randomized into the study and received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2629837|NCT01858701|Primary|Mean Ocular Coma Score at 5mm Pupil at Day 30|Ocular coma is a type of optical aberration or a distortion in image formation occurring when a bundle of light rays enters an optical system (eye) that is not parallel to the optic axis. Ocular coma will be measured in micrometers using a Ladarwave aberrometer. A lower number indicates less coma/less image distortion. One eye (right eye) contributed to the mean.|Day 30|This analysis population includes all participants who completed the study.|||micrometers||Standard Deviation|Mean
2629838|NCT01858636|Primary|The Percentage of Procedures Achieving Hemostasis Within 5 Minutes of Device Deployment.||within 5 minutes of device deployment||||% of proc. w/hemostasis within 5 min|Procedures|95% Confidence Interval|Number
2629839|NCT01858636|Primary|The Percentage of Subjects Experiencing a Device or Procedure Related Major Vascular Complication|"Major vascular complications include:~Access Site Complications:~Hematoma >10 cm in size requiring surgical or percutaneous intervention~Major bleeding requiring transfusion of ≥2 units of blood or requiring surgical or percutaneous intervention~Pain requiring a hospitalization extended for more than 24 hours or a new hospitalization, or percutaneous or surgical intervention~Infection requiring a hospitalization extended for more than 24 hours or a new hospitalization or treatment with IV antibiotics~A/V Fistula requiring medical intervention (percutaneous or surgical)~Pseudoaneurysm requiring medical intervention (percutaneous or surgical) b. Lower Limb Ischemia requiring surgical or medical intervention or resulting in permanent injury/impairment c. Retroperitoneal hemorrhage requiring intervention (percutaneous or surgical)"|30 days post procedure|All subjects with device deployments.|||% of subjects with MVCs||95% Confidence Interval|Number
2629840|NCT01858545|Primary|Number of Participants With Complete Wound Closure|Number of participants with incidence of complete wound closure|8 Weeks||||Participants|||Count of Participants
2629841|NCT01858532|Secondary|Time to the Cardiovascular Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized)|The composite event of interest for this outcome was cardiovascular (CV) death (CV death, presumed CV death), nonfatal myocardial infarction (MI; heart attack), and nonfatal stroke. Presumed sudden cardiac death was included as a sub-category of presumed CV death. Only events adjudicated by the Events Adjudication Committee (EAC) were used. Data are presented as number of participants with a cardiovascular composite event (first event per participant).|From randomization to individual end of observation, up to 53 months|Intent-to-Treat (ITT) Responders (participants who achieved at least 30% reduction in their albumin to creatinine ratio [UACR] in the Enrichment Period [EP])|||Participants|||Count of Participants
2629859|NCT01858428|Primary|Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization|Freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization through 12 months post-procedure.|30 Days and 12 months|Some Safety Status Missing at 12 Months Missing outcome status due to early study exit may differ from the total subjects exited by each visit interval as some subjects may have had a primary safety event within 12 months prior to study exit.|||Participants|||Count of Participants
2629842|NCT01858532|Secondary|Time to First Occurrence of a Component of Composite Renal Endpoint for All Randomized Participants (Pooled)|Time to the first occurrence of a component of the composite renal endpoint was defined as doubling of serum creatinine (confirmed by a 30-day serum creatinine measurement) or the onset of end stage renal disease (estimated glomerular filtration rate [eGFR] less than 15 ml/min/1.73 m^2 confirmed by a 90-day eGFR measurement, receiving chronic dialysis, renal transplantation, or renal death). Data for all randomized participants were pooled by treatment and analyzed. Data are presented as number of participants with a renal composite event (first event per participant).|From randomization to individual end of observation, up to 53 months|Intent-to-treat population: participants who were randomized to receive either atrasentan or placebo during the Double-Blind Treatment Period|||Participants|||Count of Participants
2629843|NCT01858532|Secondary|Time to Cardio-renal Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized)|The composite event of interest for this outcome consisted of doubling of serum creatinine, end-stage renal disease (ESRD), cardiovascular (CV) death (including CV death and presumed CV death), nonfatal myocardial infarction (MI; heart attack) and nonfatal stroke. Presumed sudden cardiac death was included as a subcategory of presumed CV death. Only events adjudicated by the Events Adjudication Committee (EAC) were considered in defining this endpoint. Data are presented as number of participants with a cardio-renal composite event (first event per participant).|From randomization to individual end of observation, up to 53 months|Intent-to-Treat (ITT) Responders (participants who achieved at least 30% reduction in their albumin to creatinine ratio [UACR] in the Enrichment Period [EP])|||Participants|||Count of Participants
2629844|NCT01858532|Secondary|Time to a 50% Estimated Glomerular Filtration Rate Reduction in the Intent-to-Treat (ITT) Responder Set (as Randomized)|The event of interest for this outcome was a 50% reduction in a participant's estimated glomerular filtration rate (eGFR) value as compared to baseline, confirmed by a repeated value at least 20 days apart. The event time was defined as the first time that a 50% reduction in eGFR was observed. Data are presented as number of participants with a 50% reduction in eGFR (first event per participant).|From randomization to individual end of observation, up to 53 months|Intent-to-Treat (ITT) Responders (participants who achieved at least 30% reduction in their albumin to creatinine ratio [UACR] in the Enrichment Period [EP])|||Participants|||Count of Participants
2629845|NCT01858532|Primary|Time to the First Occurrence of a Component of the Composite Renal Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized)|Time to the first occurrence of a component of the composite renal endpoint was defined as doubling of serum creatinine (confirmed by a 30-day serum creatinine measurement) or the onset of end stage renal disease (estimated glomerular filtration rate [eGFR] less than 15 ml/min/1.73 m^2 confirmed by a 90-day eGFR measurement, receiving chronic dialysis, renal transplantation, or renal death). Only events adjudicated by the Events Adjudication Committee (EAC) were considered in defining this endpoint. Data are presented as number of participants with a primary renal composite event (first event per participant).|From randomization to individual end of observation, up to 53 months|Intent-to-Treat (ITT) Responders (participants who achieved at least 30% reduction in their albumin to creatinine ratio [UACR] in the Enrichment Period [EP])|||Participants|||Count of Participants
2629846|NCT01858428|Secondary|Change in Ankle-brachial Index (ABI) From Pre-procedure|Subjects who had reinterventions were included in ABI analyses so some improvements may be reflective of revascularizations during the follow-up period.|6, 12, 24 and 36 months||||Participants|||Count of Participants
2629847|NCT01858428|Secondary|Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure|Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during the procedure.|procedure, Day 0||||Participants|||Count of Participants
2629848|NCT01858428|Secondary|Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure|Clinical success (per subject) defined as technical success without the occurrence of major adverse events during the procedure.|procedure, Day 0||||participants|||Number
2629849|NCT01858428|Secondary|Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%|Technical success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using the CVI Paclitaxel-coated PTA Catheter or bare balloon catheter without a device malfunction after wire passage through the lesion.|procedure, Day 0||||Lesion|||Number
2629850|NCT01858428|Secondary|Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%|Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using any device after wire passage through the lesion.|procedure, Day 0||||participants|||Number
2629851|NCT01858428|Secondary|Patency Rate and Freedom From Clinically-driven TLR|Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR at 6, 24 and 36 months|6, 24 and 36 months||||participants|||Number
2629852|NCT01858428|Secondary|Rate of Occurrence of Arterial Thrombosis of the Treated Segment||1, 6, 12, 24, 36, 48 and 60 months||||participants|||Number
2629853|NCT01858428|Secondary|Mortality Rate||6, 12, 24, 36, 48 and 60 months||||participants|||Number
2629854|NCT01858428|Secondary|Rate of Target Limb Major Amputation||1, 6, 12, 24, 36, 48 and 60 months||||participants|||Number
2629855|NCT01858428|Secondary|Rate of Target Lesion Revascularization||6, 12, 24, 36, 48 and 60 months||||participants|||Number
2629856|NCT01858428|Secondary|Rate of Clinically-driven Target Lesion Revascularization||6, 12, 24, 36, 48 and 60 months||||participants|||Number
2629857|NCT01858428|Secondary|Rate of Vascular Access and Bleeding Complications|Rate of vascular access and bleeding complications in the hospital and at 1, 6, 12 and 24 months.|in-hospital and 1, 6, 12 and 24 months||||participants|||Number
2629858|NCT01858428|Secondary|Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure|Major adverse event (MAE) rate in the hospital and at 1, 6, 12, 24, 36, 48 and 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).|1, 6, 12, 24, 36, 48 and 60 months||||Events|||Number
2630372|NCT01854658|Secondary|Rescue Ventolin HFA Use|Change from baseline in average daily rescue Ventolin HFA use over 24 weeks|24 weeks|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.|||Puffs / Day||95% Confidence Interval|Least Squares Mean
2629860|NCT01858428|Primary|Patency at 12 Month Post-procedure|Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.|12 months|Missing outcome status due to early study exit may differ from the total subjects exited by each visit interval as some subjects may have been eligible for failures carried forward or had a Clinically driven target lesion revasc (CD-TLR) prior to study exit.|||Participants|||Count of Participants
2629861|NCT01858389|Secondary|Changes From Time-matched Baseline in Adjusted Fridericia Corrected QT Interval (QTcF) on Echocardiogram (ECG)|ECGs recorded on Day 1 of Cycle 0 were used as baseline. For the ECGs assessments, the following directions were followed by the ECG central laboratory: Blinding of ECG readers to treatment, time, and day identifiers. Review of ECGs from a particular participant was performed by a single reader. Prespecification of the lead for internal measurements. Baseline and on-treatment ECG assessments were based on the same lead.|From Baseline to Cycle 0, Day 4|All participants who received all scheduled doses of dacomitinib and had all ECGs performed on Days 1-4 of Cycle 0 (n=number evaluable)|||msecs||90% Confidence Interval|Mean
2629862|NCT01858389|Secondary|Time to Maximum Plasma Concentration (Tmax) for Dacomitinib and PF-05199265|Tmax was observed directly from data as time of first occurrence. Whole blood for pharmacokinetic analysis was collected immediately after completion of electrocardiograms, blood pressure, and pulse rate.|Pre-dose (hour 0), 2, 4, 6, 8, and 10 hours post-dose on Day 4, Cycle 0.|All participants who received at least 1 dose of study drug and who had at least 1 measured plasma concentration of dacomitinib or its major circulating metabolite PF 05199265.|||Hours||Full Range|Median
2629863|NCT01858389|Secondary|Maximum Plasma Concentration (Cmax) for Dacomitinib and PF-05199265|Cmax was observed directly from data. Whole blood for pharmacokinetic analysis was collected immediately after completion of electrocardiograms, blood pressure, and pulse rate.|Pre-dose (hour 0), 2, 4, 6, 8, and 10 hours post-dose on Day 4, Cycle 0.|All participants who received at least 1 dose of study drug and who had at least 1 measured plasma concentration of dacomitinib or its major circulating metabolite PF 05199265.|||ng/mL||Standard Deviation|Mean
2629864|NCT01858389|Primary|Objective Response Rate (ORR) in Participants With T790M Mutation|ORR was calculated as the percentage of participants with a confirmed CR or PR relative to the total number of participants enrolled. Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.1 were used to define CR and PR. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. ORR was analyzed only for participants with T790M mutation according to the primary study objective.|From baseline to disease progression, up to 61 weeks.|All enrolled participants with T90M mutation|||Percentage of participants||95% Confidence Interval|Number
2629865|NCT01858389|Secondary|Progression-free Survival at 4 Months|Progression-free survival at 4 months was defined as the percentage of participants who were alive without disease progression at 4 months relative to all participants enrolled. Disease progression was defined by RECIST v1.1. Objective progression= ≥20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.|Month 4|All enrolled participants|||Percentage of participants||95% Confidence Interval|Number
2629866|NCT01858389|Secondary|Progression-free Survival|Progression-free survival was defined as the time from the date of first dosing of dacomitinib to the date of disease progression by RECIST v1.1, per the investigators' assessment, or death due to any cause, whichever occurred first. Objective progression= ≥20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.|From baseline to disease progression or death, up to 61 weeks.|All enrolled participants|||Months||95% Confidence Interval|Median
2629867|NCT01858389|Secondary|Duration of Response in Participants With T790M Mutation|Duration of response was defined as the time from first documentation of response (CR or PR, whichever occurred first) to the date of disease progression or to death due to any cause, whichever occurred first. CR and PR were defined using RECIST, v1.1. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. DR was only calculated and summarized for the subgroup of participants with an objective tumor response in the cohort of participants with T790M mutation.|From baseline to date of disease progression or death, up to 61 weeks.|All enrolled participants with T790M mutation status who had an objective tumor response (complete or partial response)|||Months|||Number
2629868|NCT01858389|Secondary|Disease Control Rate (DCR) for Participants With T790M Mutation|DCR was calculated as the percentage of participants with an objective response (CR or PR) or stable disease, based on the RECIST, v1.1, relative to the total number of participants enrolled in the cohort. If baseline tumor assessment was inadequate for a participant, and the participant could not be assessed for RECIST responses and had no objective status of stable disease documented at least 6 weeks after the start date and before the progression, the participant was only counted in the denominator. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. DCR was analyzed only for participants with T790M mutation according to the study objective.|From baseline to baseline to disease progression, up to 61 weeks.|All enrolled participants with T790M mutation|||Percentage of participants||95% Confidence Interval|Number
2630393|NCT01854632|Primary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Regardless of Vaccine Match)||Through 7 to 8 months post vaccination|All participants meeting per-protocol analysis criteria.|||percentage of participants|||Number
2653315|NCT01644240|Primary|Plasma CL|Plasma clearance|Day 1||||L/hr||Standard Deviation|Mean
2629869|NCT01858389|Primary|Best Overall Response (BOR) in Participants With T790M Mutation|BOR was best response from start of treatment until disease progression, according to the RECIST,v1.1. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis <10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. Progression= ≥20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions. Stable disease=not qualify for CR, PR or progression. BOR was analyzed only for participants with T790M mutation according to the primary study objective.|From baseline until disease progression, up to 61 weeks.|All enrolled participants with T790M mutation|||Participants|||Number
2629870|NCT01858376|Secondary|Changes From Baseline in Platelet Aggregometry|Adenosine Diphosphate (ADP), Arachidonic acid (AA), and Collagen (unsure about the specific type of collagen) agonists will be measured using optical platelet aggregometry. Looking at Baseline to 12 weeks on supplement with a two week washout period|Baseline and 14 weeks||||maximum % aggregation||95% Confidence Interval|Mean
2629871|NCT01858376|Secondary|C-reactive Protein|C-reactive protein in blood as measured in a standard hospital laboratory. 12 weeks on supplementation data presented.|Baseline and 14 weeks||||mg/L||Standard Deviation|Mean
2629872|NCT01858376|Secondary|Changes in High-Sensitivity C-reactive Protein|High-Sensitivity C-reactive Protein analysis in blood. Looking at Baseline to 12 weeks on supplement with a two week washout period|Baseline and 14 weeks||||mg/dl||95% Confidence Interval|Mean
2629873|NCT01858376|Primary|Change From Baseline in Lipid Profile|Blood lipid panel including HDL, LDL, total cholesterol. Looking at Baseline to 12 weeks on supplement with a two week washout period|Baseline and 14 weeks|number of participants analyzed is different from the participant flow module due to subjects who self reported non-compliance from pill count of the supplements and their data was not able to be used for this outcome measure.|||mg/dl||95% Confidence Interval|Mean
2629874|NCT01858194|Secondary|Procedure Time|Renal Denervation Procedure time|during procedure|Results only for those participants who underwent renal sympathetic denervation|||minutes||Standard Deviation|Mean
2629875|NCT01858194|Secondary|Number of Occurrences of Major Complication Rate|30-day Major Complication Rate defined as death, stroke, MI or any other serious adverse events related to the treatment or procedure within the first 30 days or through hospital discharge (whichever is longer)|30 days||||occurrences|||Number
2629876|NCT01858194|Secondary|Number of Participants With Other Complications|Other individual complication rates including, but not limited to MI and death|at 24 months||||Participants|||Count of Participants
2629877|NCT01858194|Secondary|Number of Participants With Orthostatic Hypertension|Number of participants with other individual complication rates specifically orthostatic hypertension|24 months||||Participants|||Count of Participants
2629878|NCT01858194|Secondary|Changes in Mean Arterial Pressure|Change in mean arterial pressure|baseline and 24 months|Results only available for participants with data for both timepoints.|||mmHg||Standard Deviation|Mean
2629879|NCT01858194|Secondary|Number of Procedure-related Adverse Events|Procedure related adverse events including, but not limited to hematomas, pseudoaneurysms, renal artery stenosis, renal impairment, thromboembolic events, stroke, pericardial bleeding including tamponade and myocardial infarction.|24 months||||events|||Number
2629880|NCT01858194|Secondary|Change in LV Size|LV size measured by trans-thoracic echocardiography, as compared at 12 months to baseline|baseline and 12 months|Results only available for participants with data for both timepoints.|||cm||Standard Deviation|Mean
2629881|NCT01858194|Secondary|Differences in BUN/Creatinine Measurements|Differences in BUN/creatinine measurements compared at 12 months to baseline.|baseline and 12 months|Results only available for participants with data for both timepoints.|||mg/dL||Standard Deviation|Mean
2629882|NCT01858194|Secondary|Change in Brain Natriuretic Peptide (BNP)|Differences in blood hormone measurements as measured by BNP as compared on 12 months to baseline.|at baseline and at 12 months|results only for those participants who have both timepoint data|||mg/dL||Standard Deviation|Mean
2629883|NCT01858194|Secondary|Number of Participants With Occurrences of ICD Storm|The occurrence of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours.|24 months||||Participants|||Count of Participants
2629884|NCT01858194|Secondary|Number of Participants With All-Cause Mortality||24 months||||Participants|||Count of Participants
2629885|NCT01858194|Secondary|Number of Episodes of Total VT Burden|Total VT burden (Number of episodes)|at 24 months||||episodes|||Number
2629886|NCT01858194|Secondary|Number of Participants With Hospitalizations for Cardiovascular Causes||24 months||||Participants|||Count of Participants
2629887|NCT01858194|Secondary|Number of Participants With Mortality, ICD Storm and Incessant VT|Number of Participants with a composite of Mortality, ICD storm, and Incessant VT|24 months||||Participants|||Count of Participants
2629888|NCT01858194|Secondary|All ICD Therapies (Appropriate + Inappropriate)|cumulative ICD therapies including both appropriate and inappropriate shocks|24 months||||occurrences|||Number
2629889|NCT01858194|Secondary|Number of Inappropriate ICD Therapy|Number of inappropriate ICD therapy including both appropriate and inappropriate shocks|at 24 months||||occurrences|||Number
2629890|NCT01858194|Secondary|Number of Appropriate ICD Shocks for Ventricular Arrhythmia|An Appropriate ICD therapy is defined as anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.|at 24 months||||occurrences|||Number
2629891|NCT01858194|Primary|Freedom From First Event Requiring ICD Therapy|Probability of freedom from first event requiring ICD therapy at 12 months and at 24 months|24 months||||probability of freedom|||Number
2629892|NCT01857986|Post-Hoc|Duration of Significant CO2 Leakage|Time (minutes) of CO2 leakage readings at or above 2 mmHg|Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days||||minutes||Standard Deviation|Mean
2630394|NCT01854593|Secondary|Silicon Oil Tamponade|The number of participants with silicon oil tamponade at the end of the surgery.|End of surgery.||||participants|||Number
2629893|NCT01857986|Secondary|Number of the Cuff Pressure Measurements Within the Safety Accepted Range (24 and 40cmH2O)|mean number of cuff pressure measurements within the safety accepted range of 24 and 40 cmH2O, normalized using the total number of valid cuff pressure measurements.|Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days||||normalized number of Cp measurements||Standard Deviation|Mean
2629894|NCT01857986|Primary|CO2 Leakage Above the ETT Cuff, Measured Over Time.|"Trial outcome measure represents patients' exposure to CO2 leakage standardized per hour. Specifically, each patients' area under the curve (AUC) of CO2 leakage (mmHg) is computed over the whole trial by multiplying leakage duration (X-axis; continuous time) by CO2 level (Y-axis; mmHg), divided by the patient's number of hours in the trial. Outcome measure is thus [CO2 mmHg*hour]/hour.~CO2 leakage is the concentration of CO2 above the cuff as measured by the AG100 system every few minutes (in clinical mode). Time points which created the curve were every two adjacent time intervals having a valid CO2 reading."|Subjects will be followed for the duration of endotracheal intubation, an expected average of 4 days||||[CO2 mmHg*hour]/hour||Standard Deviation|Mean
2629895|NCT01857973|Secondary|Percentage of Time in Euglycemic Range - Phase 7|Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 7|7 days||||percentage of time||Standard Deviation|Mean
2629896|NCT01857973|Secondary|Percentage of Time in Euglycemic Range - Phase 6|Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 6|7 days||||percentage of time||Standard Deviation|Mean
2629897|NCT01857973|Secondary|Percentage of Time in Euglycemic Range - Phase 4|Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 4|12 days||||percentage of time||Standard Deviation|Mean
2629898|NCT01857973|Secondary|Percentage of Time in Euglycemic Range - Phase 2|Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 2|3 days||||percentage of time||Standard Deviation|Mean
2629899|NCT01857973|Secondary|Number of Subject Under-calibrated to Introduce a Persistent Under-reading Sensor Measurement Bias- Phase 1|Number of subject under-calibrated to introduce a persistent under-reading sensor measurement bias- Phase 1|1 day|13 subjects with sensors under-calibrated to introduce a persistent under-reading sensor measurement bias|||participants|||Number
2629900|NCT01857973|Secondary|Number of Subject With YSI (Yellow Spring Instrument) Dipped Below 50mg/dL - Exploratory B Phase|The purpose of exploratory B study was to evaluate the efficacy and safety of the insulin upper-limit, Umax. The Umax is a patient-specific parameter which is calculated based on historical data from the pump that includes SG tracings, insulin delivery information, and the carbohydrate inputs from the user. The main objective of Umax is to prevent the user from being severely hypoglycemic (less than 50 mg/dL) by restricting the controller from over-delivery of insulin.|1 day|Five out of the eight subjects with YSI dipped below 50mg/dL|||number of subjects|||Number
2629901|NCT01857973|Secondary|Percentage of Time in Euglycemic Range - Exploratory A Phase|Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Exploratory A phase. An overnight closed-loop experiment was performed using the Android Development Platform, software version 2.0 A system's closed-loop algorithm without implementing the upper-limit for insulin delivery.|1 day||||percentage of time||Standard Deviation|Mean
2629902|NCT01857973|Primary|Percentage of Time in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform)|time in euglycemic range (% of Senosr Glucose (SG) 70-180 mg/dL), Phase 3 (closed-loop using the Next Generation Pump (NGP) platform). The experiment was conducted in a monitored setting which lasted for 12 days with the following stressors: missed meal bolus, exercise, missed transmission, Umax (maximum insulin limit) challenges. The study was conducted in a clinic or hotel/house environment for 12 days/11 nights with no dietary or activity restrictions.|12 days|Eight type-1 diabetic subjects participated in this phase.|||percentage of time||Standard Deviation|Mean
2629903|NCT01857882|Other Pre-specified|Completion of Primary Outcome Measure-feasibility Outcome|Patients are to complete the primary outcome one week after initial consultation. However, it is expected that some patients may take longer to complete this intervention (on average 1 month after consultation), and will require reminder telephone calls.|1 week after initial consultation|||||||
2629904|NCT01857882|Other Pre-specified|Retention After Randomized Treatment Assignment (Workshop and Consultation Attendance)-Feasibility Outcome|The number of participants who completed their assigned treatment (workshop and consultation vs. consultation alone) will be recorded. This will be recorded directly after each day the treatment is delivered.|Duration of treatment-8 hours on day of treatment|||||||
2629905|NCT01857882|Other Pre-specified|Recruitment Rate-feasibility Outcome|As this is a pilot study, the feasibility of conducting the study is highly important. The recruitment rate of participants will be measured, during the recruiting period which is expected to be on average two months.|Duration of recruiting, expected on average two months|||||||
2629906|NCT01857882|Secondary|Medical Outcomes Study Social Support Survey|Medical Outcomes Study Social Support Survey has a series of 18 questions that measure 4 domains of social support (emotional, tangible, affectionate, and social interactions). Responses range from 1 (none of the time) to 5 (all the time). The items in each domain were summed and then transformed to yield scores ranging from 0 to 100. Higher scores indicate more support.|baseline|||||||
2629907|NCT01857882|Secondary|Breast Reconstruction Knowledge Test|This breast reconstruction knowledge test is a 12-item 3-response questionnaire that records the score on a continuous integer scale, and measured patient's knowledge regarding breast reconstruction.|Change in baseline breast reconstruction knowledge at 1 week after initial consultation|||||||
2629908|NCT01857882|Secondary|Number of Consultations-service Outcomes|The number of consultations with the plastic surgeon until the patient has made a reconstruction choice (defined as signing a surgical consent form) will be recorded. Patients can spend months considering their choices, so it is appropriate to follow them for a period of at least six months after their initial consultation.|Six months after initial consultation|||||||
2629909|NCT01857882|Secondary|Length of Consultation-service Outcome|The length of the initial consultation with the plastic surgeon, measured in minutes. Consultations are expected to be between 20-60 mins.|Duration of initial consultation|||||||
2629910|NCT01857882|Secondary|Uptake Rate of Breast Reconstruction-Service Outcome|The uptake rate of breast reconstruction (if patients chose breast reconstruction or no reconstruction)|Six months after initial consultation|||||||
2630395|NCT01854593|Secondary|Gas Tamponade|The number of participants with gas tamponade at the end of the surgery.|End of surgery.||||participants|||Number
2629911|NCT01857882|Secondary|Qualitative Interview Assessment|A subgroup of participants allocated to both the experimental and usual care groups will be asked to participate in a brief qualitative telephone interview. Purposeful sampling will be used to recruit 5 patients from each group to achieve data saturation and variability. Telephone interviews will be conducted by a social worker trained in qualitative methods. All participants randomized to the workshop will additionally be asked to complete a written survey for evaluation of the intervention immediately after participation in the workshop.|Within three months after initial consultation|||||||
2629912|NCT01857882|Secondary|Satisfaction With Information (Sub-scale of BREAST-Q)|"The BREAST-Q is a procedure-specific and validated PRO that measures Hr-QOL and patient satisfaction with breast reconstruction. The Satisfaction with Information Subscale specifically measures patient satisfaction with the preoperative information and care provided by the plastic surgeon and other members of the medical team. There are 15 items that use a four-level Likert scale response format, the score is transformed on a scale of 0 to 100 with higher scores indicating greater satisfaction."|T1 (1 week after surgical consultation)|||||||
2629913|NCT01857882|Secondary|Patient Involvement in Care Scale (PICS)|PICS is a measure of patient perception of involvement with her care, and has seven 5-point Likert scale items that assess the extent to which the patient asked questions, offered opinions, and expressed concerns when meeting with the surgeon.|T1 (1 week after surgical consultation)|||||||
2629914|NCT01857882|Secondary|Decision Preference and Decision Choice|Decision Preference and Decision Choice has been used as a primary and secondary outcome in studies of decision support interventions in cancer patients. It demonstrates good test-retest reliability (test-retest coefficient > 0.90) and is sensitive to change when measured before and after an intervention.|baseline|||||||
2629915|NCT01857882|Secondary|Decision Conflict Scale|Decision conflict scale measures personal perceptions of uncertainty in choosing options and has been demonstrated to be valid and responsive to change. The decisional conflict scale is a 16-item 5-response instrument that reports a score from 0 - 100 with higher scores indicating more conflict (items are summed, divided by 16 and multiplied by 25).|Change from baseline decision conflict at 1 week after surgical consultation|||||||
2629916|NCT01857882|Primary|Decision Self-efficacy Scale|"Decision self-efficacy (DSE) scale is a prospectively designed instrument to evaluate patient self-confidence in decision-making, including shared decision-making. It has been validated among women facing treatment decisions for osteoporosis and used in cancer patients. Psychometric evaluation has shown high levels of internal consistency (Cronbach alpha 0.90). Decision self-efficacy is correlated with decision conflict subscales of feeling informed (r = 0.47) and supported (r = 0.45). This instrument has never been tested in the breast cancer or breast reconstruction population.~The total score is calculated by summing the 11 items, dividing by 11 and multiplying by 25. Scores range from 0 (extremely low self-efficacy) to 100 (extremely high self-efficacy).~The mean and standard deviation (SD) were calculated at baseline and after the initial consultation. Change in score was defined as the difference in total score between baseline and after consultation."|Change from baseline decision self-efficacy at 1 week after surgical consultation||||units on a scale||Standard Deviation|Mean
2629917|NCT01857869|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (Up to Day 105 of Booster Phase)|The analysis was based on the ITT population, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2629918|NCT01857869|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From study start to end of Primary Phase (Study Day 245)|The analysis was based on the ITT population, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2629919|NCT01857869|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 30-days (Days 0-29) post- second CHMI|The analysis was based on the ITT population for the rechallenge, which included subjects from the ITT population consenting to the rechallenge.|||Participants|||Count of Participants
2629920|NCT01857869|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 30-days (Days 0-29) post-first CHMI|The analysis was based on the ITT population, which included all subjects with at least one vaccine administration documented and who had post-first CHMI available results.|||Participants|||Count of Participants
2629921|NCT01857869|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 30-days (Days 0-29) post- booster vaccination|The analysis was based on the ITT population for the rechallenge, which included subjects from the ITT population consenting to the rechallenge. For the purpose of the analysis, subjects who received a low fractional formulation booster dose of GSK257049 vaccine have been pooled into a single group and results were tabulated accordingly.|||Participants|||Count of Participants
2630396|NCT01854593|Secondary|Elevated Intraocular Pressure|The number of participants with elevated intraocular pressure after surgery.|Within 1 month after the surgery.||||participants|||Number
2629922|NCT01857869|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 30-days (Days 0-29) post-primary vaccination|The analysis was based on the ITT population, which included all subjects with at least one vaccine administration documented. Results were not reported for the Infectivity Control Group, since subjects from this group did not receive any immunization.|||Participants|||Count of Participants
2629923|NCT01857869|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever [defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 7-day (Days 0-6) post- booster vaccination period|The analysis was based on the ITT population for the rechallenge, which included subjects from the ITT population consenting to the rechallenge. For the purpose of the analysis, subjects who received a low fractional formulation booster dose of GSK257049 vaccine have been pooled into a single group and results were tabulated accordingly.|||Participants|||Count of Participants
2629924|NCT01857869|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Days 0-6) post- booster vaccination period|The analysis was based on the ITT population for the rechallenge, which included subjects from the ITT population consenting to the rechallenge. For the purpose of the analysis, subjects who received a low fractional formulation booster dose of GSK257049 vaccine have been pooled into a single group and results were tabulated accordingly.|||Participants|||Count of Participants
2629925|NCT01857869|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting and/or abdominal pain), headache and fever [defined as axillary temperature equal to or above (≥) 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was based on the ITT population, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in. Results were not reported for the Infectivity Control Group, since subjects from this group did not receive any immunization.|||Participants|||Count of Participants
2629926|NCT01857869|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was based on the Intention-to-Treat (ITT) population, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in. Results were not reported for the Infectivity Control Group, since subjects from this group did not receive any immunization.|||Participants|||Count of Participants
2629927|NCT01857869|Secondary|Anti-CS Repeat Region IgG Avidity Index for the Rechallenge Phase|The avidity index percentage was calculated by anti-CS repeat region titer under chaotropic reagent/anti-CS repeat region titer without chaotropic reagent. The median and inter-quartile (Q1 and Q3) range was reported at the prespecified time-points.|Pre-booster dose (Booster phase Day 0) and at DoC Booster/rechallenge phase (Day of Controlled Human Malaria Infection - Day 21)|The analysis was based on the ATP population for immunogenicity and efficacy for the rechallenge, which included all subjects from the ATP population for immunogenicity and efficacy who consented to the rechallenge. Results were not reported for the Control Group Follow-up, since subjects from this group did not receive any immunization.|||Avidity index||Inter-Quartile Range|Median
2629928|NCT01857869|Secondary|Anti-CS Repeat Region Immunoglobulin G (IgG) Avidity Index for the Challenge Phase|The avidity index percentage was calculated by anti-CS repeat region concentration under chaotropic reagent/anti-CS repeat region concentration without chaotropic reagent. The median and inter-quartile (Q1 and Q3) range was reported at the prespecified time-points.|Post-dose 1 at Day 28, post-dose 2 at Days 56, and 196, DoC PP (DoC = the day of CHMI, Day 217), DoC PP (Day 217) + 84 days (Day 301) and DoC PP (Day 217) +159 days (Day 376)|The analysis was based on the ATP population for immunogenicity and efficacy, which included all subjects who complied with the protocol requirements and underwent P. falciparum CHMI.|||Avidity index||Inter-Quartile Range|Median
2629929|NCT01857869|Secondary|Anti-HBs Antibody Concentrations for Rechallenge Phase|Anti-HBs antibody concentrations were determined by Chemiluminometric Immunoassay (CLIA).|At Day 0 of rechallenge (pre-booster dose) and at DoC PP (Day 217 = Day of rechallenge)|The analysis was based on the ATP population for immunogenicity and efficacy for the rechallenge, which included all subjects from the ATP population for immunogenicity and efficacy who consented to the rechallenge.|||mIU/mL||95% Confidence Interval|Geometric Mean
2629930|NCT01857869|Secondary|Antibody Concentrations Against Hepatitis B Surface Antigen (Anti-HBs)|Anti-HBs antibody concentrations were determined by Chemiluminometric Immunoassay (CLIA) and expressed as miliinternation units per mililier (mIU/mL).|7 days before vaccination (D-7), post-dose 1 at Day 28, post-dose 2 at Days 42, 56, 98, 196 after first dose, at DoC PP (Day of CHMI = Day 217), at DoC PP (Day 217)+ 7, 14, 28, 42, 56, 70, 84, 159 days (Days 224, 231, 245, 259, 273, 287, 301, 376).|The analysis was based on the ATP population for immunogenicity and efficacy, which included all subjects who complied with the protocol requirements and underwent P. falciparum CHMI.|||mIU/mL||95% Confidence Interval|Geometric Mean
2630397|NCT01854593|Secondary|Postoperative Neovascular Glaucoma|The number of participants with progressive or persistent neovascular glaucoma after surgery.|Within 1 month after the surgery.||||participants|||Number
2629931|NCT01857869|Secondary|Frequency of CS Repeat and T-cell Epitope (RT)-Specific CD8 T-cells|Frequency of CD8 polypositives T-cells with at least 2 cytokines/activation markers between CD40-L, INF-g, IL-2 and TNF-a was assessed for PBMC with ICS.|7 days before vaccination (D-7), post-dose 1 at Day 14, post-dose 2 at Day 42, at DoC PP (Day of CHMI = Day 217), at DoC PP (Day 217) + 7, 28, 84, 159 days (Days 224, 245, 301, 376).|The analysis was based on the ATP population for immunogenicity and efficacy, which included all subjects who complied with the protocol requirements and underwent P. falciparum CHMI, with cellular mediated immunity data available.|||CD8+ T-cells/million CD8 T-cells||Standard Deviation|Mean
2629932|NCT01857869|Secondary|Frequency of CS Repeat and T-cell Epitope (RT)-Specific Cluster of Differentiation 4 (CD4) T-cells|Frequency of Cluster of Differentiation 4 (CD4) polypositives T-cells with at least 2 cytokines/activation markers between CD40-Ligand (CD40-L), interferon gamma (INF-g), interleukin-2 (IL-2) and tumor necrosis factor-alpha (TNF-a) was assessed for peripheral blood mononuclear cells (PBMC) with intracellular cytokine staining (ICS).|7 days before vaccination (D-7), post-dose 1 at Day 14, post-dose 2 at Day 42, at DoC PP (Day of CHMI = Day 217), at DoC PP (Day 217) + 7, 28, 84, 159 days (Days 224, 245, 301, 376).|The analysis was based on the ATP population for immunogenicity and efficacy, which included all subjects who complied with the protocol requirements and underwent P. falciparum CHMI, with cellular mediated immunity data available.|||CD4+ T-cells/million CD4 T-cells||Standard Deviation|Mean
2629933|NCT01857869|Secondary|Anti-CS Repeat Region Antibody Concentrations for the Rechallenge Phase|Anti-CS antibody concentrations were determined by Enzyme Linked Immunosorbent Assay (ELISA) and expressed as EU/mL.|At Day 0 of rechallenge (pre-booster dose) and at DoC PP (Day 217 = Day of rechallenge)|The analysis was based on the ATP population for immunogenicity and efficacy for the rechallenge, which included all subjects from the ATP population for immunogenicity and efficacy who consented to the rechallenge.|||EU/mL||95% Confidence Interval|Geometric Mean
2629934|NCT01857869|Secondary|Anti-circumsporozoite (Anti-CS) Repeat Region Antibody Concentrations|Anti-CS antibody concentrations were determined by Enzyme Linked Immunosorbent Assay (ELISA) and expressed as EU/mL.|7 days before vaccination (D-7), post-dose 1 at Day 28, post-dose 2 at Days 42, 56, 98, 196, at DoC Primary Phase (PP) (Day of CHMI = Day 217), at DoC PP (Day 217) + 7, 14, 28, 42, 56, 70, 84, 159 days (Days 224, 231, 245, 259, 273, 287, 301, 376).|The analysis was based on the ATP population for immunogenicity and efficacy, which included all subjects who complied with the protocol requirements and underwent P. falciparum CHMI.|||EU/mL||95% Confidence Interval|Geometric Mean
2629935|NCT01857869|Secondary|Time to Onset of P. Falciparum Parasitemia Infection Defined by a Positive Blood Slide, Following Sporozoite Rechallenge|The time to onset was expressed in days. The definition of malaria infection for primary and secondary efficacy outcomes is the appearance of asexual blood stage P. falciparum parasites detected by blood slide at any time post challenge/rechallenge up to 28 days.|Up to 28 days post rechallenge (Booster Phase Day 49)|The analysis was based on the ATP population for immunogenicity and efficacy for the rechallenge Phase, which included all subjects from the ATP population for immunogenicity and efficacy who consented to the rechallenge. This analysis included those subjects with a positive blood slide.|||Days||Standard Deviation|Mean
2629936|NCT01857869|Secondary|Number of Subjects With Plasmodium Falciparum Parasitemia Defined by a Positive Blood Slide, Following Sporozoite Rechallenge|The definition of malaria infection for primary and secondary efficacy outcomes is the appearance of asexual blood stage P. falciparum parasites detected by blood slide at any time post challenge/rechallenge up to 28 days.|Up to 28 days post rechallenge (Booster Phase Day 49)|The analysis was based on the ATP population for immunogenicity and efficacy for the rechallenge Phase, which included all subjects from the ATP population for immunogenicity and efficacy who consented to the rechallenge.|||Participants|||Count of Participants
2629937|NCT01857869|Secondary|Time to Onset of P. Falciparum Parasitemia Infection Defined by a Positive Blood Slide, Following Sporozoite Challenge|The time to onset was expressed in days. The definition of malaria infection for primary and secondary efficacy outcomes is the appearance of asexual blood stage P. falciparum parasites detected by blood slide at any time post challenge/rechallenge up to 28 days.|Up to 28 days post-challenge (Study Day 245)|The analysis was based on the ATP population for immunogenicity and efficacy, which included all subjects who complied with the protocol requirements and underwent P. falciparum CHMI. This analysis included those subjects with a positive blood slide.|||Days||Standard Deviation|Mean
2629938|NCT01857869|Primary|Number of Subjects With Plasmodium Falciparum Parasitemia Defined by a Positive Blood Slide, Following Sporozoite Challenge|The definition of malaria for primary and secondary efficacy outcomes is the appearance of asexual blood stage P. falciparum parasites detected by blood slide at any time post challenge/rechallenge up to 28 days.|28 days post-challenge (Study Day 245)|The analysis was based on the According-to-Protocol (ATP) population for immunogenicity and efficacy, which included all subjects who complied with the protocol requirements and underwent P. falciparum CHMI.|||Participants|||Count of Participants
2629939|NCT01857713|Other Pre-specified|Investigator Questionnaire|Investigators provide their perception of the device at the end of the study.|4 Weeks|||||||
2629940|NCT01857713|Other Pre-specified|Patient Satisfaction|Patients provide their perception of the device at the end of the study.|4 Weeks|||||||
2629941|NCT01857713|Secondary|Functional Outcomes of Sleep Questionnaire (FOSQ)|The FOSQ is a self-report measure (0-4 for each of 30 questions) designed to assess the impact of disorders of excessive sleepiness (DOES) on multiple activities of everyday living that includes areas of physical, mental and social functioning. Scores can range from 0 (worst possible outcome) to 120 (best possible outcome). Zero (0) is defined as not doing that specific activity for other reasons.|4 Weeks minus Baseline|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).|||Change in Units on a Scale||Standard Deviation|Mean
2629968|NCT01857297|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.|For the H1N1, H3N2 and B influenza virus strains. Note: No SRH data were collected.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with the Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.|||percentage of participants||95% Confidence Interval|Number
2629942|NCT01857713|Secondary|SF-36 Short Form Health Survey - 4 Week Follow-up Score Compared to Baseline Score|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|4 Weeks minus Baseline|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).|||Change in Units on a Scale||Standard Deviation|Mean
2629943|NCT01857713|Primary|Primary Safety|Adverse reactions reported were evaluated with the frequency and percent of subjects of each reaction being summarized by severity and by relationship to the Reza Band UES Assist Device.|4 Week Follow-up|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).|||% Reporting Any Adverse Event|||Number
2629944|NCT01857713|Primary|Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks|The RSI is a validated nine-item patient-administered outcome questionnaire designed to document symptoms and severity. Patients are asked to rate how nine problems have affected them on a scale of 0 (no problem) to 5 (severe problem), with a maximum total score of 45).|4 Weeks minus Baseline||||Per Cent Change||Standard Deviation|Mean
2629945|NCT01857622|Primary|Incidence of Any Adjudicated Bleeding Events|Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding)|3 months||||percentage of subjects with bleeds||95% Confidence Interval|Number
2629946|NCT01857583|Secondary|Incidence of Adjudicated Thromboembolic Events|Incidence of adjudicated thromboembolic events (symptomatic Deep Vein Thrombosis (DVT), symptomatic Pulmonary Thromboembolism (PTE), Venous Thromboembolism (VTE) related deaths).|1 month|||||||
2629947|NCT01857583|Primary|Plasma Concentration of D21-2393||14 days|||||||
2629948|NCT01857583|Primary|Plasma Concentration of DU-176b||14 days|||||||
2629949|NCT01857583|Primary|Incidence of Adverse Drug Reactions||1 month|||||||
2629950|NCT01857583|Primary|Incidence of Adverse Events||1 month|||||||
2629951|NCT01857583|Primary|Incidence of Any Adjudicated Bleeding Events|Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding).|14 days|The safety analysis set was defined as all subjects who were enrolled in the study, except for those who had significant GCP violations, who had not received the study drug, or who had no safety data after the start of study treatment.|||percentage of subjects with bleeds||95% Confidence Interval|Number
2629952|NCT01857531|Other Pre-specified|Number of Participants Completing Abstinence From Smoking During the Last Four Weeks of Treatment|End of treatment abstinence from smoking during the last four weeks of treatment, based on self-reported abstinence during last four weeks confirmed by expired air CO|4 Week abstinence from smoking at 6 weeks post quit||||participants||95% Confidence Interval|Number
2629953|NCT01857531|Other Pre-specified|Number of Participants Completing Continuous 6-week Abstinence From Smoking|Continuous six week abstinence from smoking at final study visit (approximately 6 weeks post quit date), based on self-reported abstinence confirmed by expired air CO|6 Weeks post quit|Because 6-week abstinence is counted backward from the final study visit, one additional subject (n=4) qualified as abstinent than at 2-weeks post-quit (n=3) due to the fact that the day(s) that one of the subjects smoked did not fall into the range evaluated at 6 weeks.|||participants||95% Confidence Interval|Number
2629954|NCT01857531|Other Pre-specified|Number of Participants Completing Point Abstinence From Smoking Two Weeks After Quitting|Point abstinence from smoking two weeks post quit, based on self-reported abstinence during last seven days confirmed by expired air CO at first post-quit visit.|7 day point abstinence from smoking at 2 weeks post quit||||participants||95% Confidence Interval|Number
2629955|NCT01857531|Other Pre-specified|Number of Participants Completing Continuous 2-week Abstinence From Smoking|Continuous two week abstinence from smoking at the first post-quit visit (approximately 2 weeks post quit date), based on self-reported abstinence confirmed by expired air CO.|2 Weeks post quit||||participants||95% Confidence Interval|Number
2629956|NCT01857531|Secondary|Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 4|To evaluate the effects of ganaxolone as an augmentation treatment in conjunction with nicotine patch by looking at the percent change in expired air CO at the end of week four (relative to baseline).|Baseline and 4 Weeks|Three of the original 16 subjects dropped out prior to week 4, so only 13 subjects had a week 4 CO reading and could be included in this analysis.|||percentage change||Standard Error|Mean
2629957|NCT01857531|Primary|Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 2|To evaluate the effects of ganaxolone on ad lib smoking by looking at the percent change in expired air CO at the end of week two (relative to baseline).|Baseline and 2 Weeks||||percentage change||Standard Error|Mean
2629958|NCT01857362|Primary|The Maximum Serum Concentration (Cmax).||Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose|Full analysis set was used; subjects with available PK data for at least one of the treatments.|||nM||Full Range|Geometric Mean
2629959|NCT01857362|Primary|The Area Under the Serum Concentration vs. Time Profile During 72 Hours After Dose (AUC72h).||Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose|Full analysis set was used; subjects with available PK data for at least one of the treatments.|||uM*h||Full Range|Geometric Mean
2629969|NCT01857297|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI (H1N1, H3N2, and B influenza virus strains) is defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with the Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.|||fold increase||Standard Deviation|Geometric Mean
2630398|NCT01854593|Secondary|Best Corrected Visual Acuity Change|"Best corrected visual acuity change was calculated by postoperative logMAR visual acuity minus preoperative logMAR visual acuity.~The higher values represent a worse outcome."|1 month||||LogMAR||Standard Deviation|Mean
2629960|NCT01857323|Secondary|Participants With Treatment-Emergent Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Day 50|Safety population|||participants|||Number
2629961|NCT01857323|Secondary|Absolute Value of Total Discrepancy Size Per Inhaler|"The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome is calculated for each inhaler as beginning counter reading minus end counter reading minus patient-recorded number of dose cycles. The total inhaler discrepancy size is an important measure because it provides the most relevant means of ensuring that the inhaler does not exhaust its supply of albuterol before the counter has recorded the labeled 200 doses."|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.|||discrepancies/inhaler||Standard Deviation|Mean
2629962|NCT01857323|Secondary|Dosing Discrepancies Per 200 Dose Cycles: Count Up Unknown Dose Cycle|"The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures when the inhaler counter counts upwards (number increases, e.g. 50 to 52) rather than downward between dosing sessions but the participant has not knowingly executed the dose cycle (i.e., the counter number at the beginning of the dosing session is greater than the counter number at the end of the previous dosing session). The discrepancy rate was calculated as number of discrepancies/total number of dose cycles *200."|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.|||discrepancies/200 dose cycles|Participants||Number
2629963|NCT01857323|Secondary|Dosing Discrepancies Per 200 Dose Cycles: Count Unknown Dose Cycle|"The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures when the inhaler counter advances (decreases, e.g., 50 to 48) between dosing sessions but the participant has not knowingly executed the dose cycle (i.e., the counter number at the beginning of the dosing session is less than the counter number at the end of the previous dosing session). The discrepancy rate was calculated as number of discrepancies/total number of dose cycles *200."|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.|||discrepancies/200 dose cycles|Participants||Number
2629964|NCT01857323|Secondary|Dosing Discrepancies Per 200 Dose Cycles: Dose Cycle Count Up|"The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures when the inhaler counter reading increases, instead of decreases, after the participant has executed the dose cycle (i.e., the ending counter reading is greater than the beginning counter reading within a dosing session). The discrepancy rate was calculated as number of discrepancies/total number of dose cycles *200."|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.|||discrepancies/200 dose cycles|Participants||Number
2629965|NCT01857323|Primary|Dosing Discrepancies Per 200 Dose Cycles: Dose Cycle Not Count|"The purpose of the study is to determine if the dose counter on Albuterol Spiromax is counting accurately; accuracy is determined by concordance/agreement between patient-reported Albuterol Spiromax counter readings and patient-reported dose cycles recorded in patient diaries. This outcome measures how often the dose cycle was not counted: the participant completes a full dose cycle (opens the mouthpiece cap, inhales the medication, and closes the mouthpiece cap) but the counter display does not advance (i.e., does not count down) within a dosing session. The discrepancy rate was calculated as number of discrepancies/total number of dose cycles *200."|Day 1 - Day 50|Per protocol population includes all data from randomized participants who have not experienced major protocol violations prior to dosing with at least 180 inhaled doses. Participants in the 35-day subgroup are excluded from the PP population, as they will only have taken approximately 140 doses during the study.|||discrepancies/200 dose cycles|Participants||Number
2629966|NCT01857297|Secondary|Frequency of Any Unsolicited AEs|The percentage of participants reporting any unsolicited AEs. Unsolicited AEs include AEs other than those specifically solicited.|After vaccination until the end of the study; approximately 21 days.|The Safety Population included all participants who received the Influenza Vaccine and provided follow-up safety data.|||percentage of participants|||Number
2629967|NCT01857297|Secondary|Frequency of Any Solicited Adverse Events (AEs)|The percentage of participants reporting any solicited AEs.|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population included all participants who received the Influenza Vaccine and provided follow-up safety data.|||percentage of participants|||Number
2630012|NCT01856790|Other Pre-specified|Differences in Daily Insulin Requirements||24 hours||||units||Standard Deviation|Mean
2629970|NCT01857297|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion (H1N1, H3N2, and B influenza virus strains) is defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10. A significant increase (H1N1, H3N2, and B influenza virus strains) is defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with the Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.|||percentage of participants||95% Confidence Interval|Number
2629971|NCT01857258|Secondary|Ratio of Asymmetric Dimethylarginine Relative to Arginine||60 min (baseline)||||nmol/umol||Standard Error|Mean
2629972|NCT01857258|Secondary|Ratio of Asymmetric Dimethylarginine Relative to Arginine||0 min (baseline)||||nmol/umol||Standard Error|Mean
2629973|NCT01857258|Secondary|Malondialdehyde||60 min postprandially||||uM||Standard Error|Mean
2629974|NCT01857258|Secondary|Malondialdehyde (0 Min)||Baseline (0 min)||||uM||Standard Error|Mean
2629975|NCT01857258|Primary|Brachial Artery Flow-mediated Dilation||60 min||||% dilation||Standard Error|Mean
2629976|NCT01857258|Primary|Brachial Artery Flow-mediated Dilation||0 min (baseline)||||% dilation||Standard Error|Mean
2629977|NCT01857258|Primary|Area Under the Curve of Brachial Artery Flow Mediated Dilatiion|Brachial artery flow-mediated dilation will be measured at 0, 30, 60, 90, 120, 150, and 180 minutes following the ingestion of a confection.|Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose||||%FMD * min||Standard Error|Mean
2629978|NCT01857258|Primary|Area Under the Curve of Blood Glucose|Blood glucose will be measured at 0, 30, 60, 90, 120, 150 and 180 minutes following the ingestion of a confection to calculate area under the concentration-time curve.|Area under the Curve, 0, 30, 60, 90, 120, 150, 180 minutes post-dose||||mmol/L * min||Standard Error|Mean
2629979|NCT01857232|Secondary|Number of Participants With CR in the Overall Phase.|CR defined as no emesis and no use of rescue medication, in the overall phase (0 to 120 hours after the initiation of chemotherapy)|0 to 120 hours after the initiation of chemotherapy||||Participants|||Count of Participants
2629980|NCT01857232|Primary|Number of Participants With Delayed Phase Complete Response(CR)|"Delayed phase complete response (CR), defined as an absence of emetic episodes and no rescue medication use in the period from 24 to 120 hours after the initiation of chemotherapy.~The primary endpoint was analysed separately in the strata of chemotherapy regimen and gender, and in the strata of country."|24-120 hours|ITT|||Participants|||Count of Participants
2629981|NCT01857206|Primary|Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.|Safety was assessed as the number of subjects who reported serious adverse events (SAEs), medically attended AEs and new onset of chronic diseases (NOCD) in subjects aged ≥4 To ≤17 Years.|Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects|Analysis was done on the unsolicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination unsolicited safety data.|||Subjects|||Number
2629982|NCT01857206|Primary|Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.|Safety was assessed as the number of subjects who reported unsolicited adverse events following vaccination with either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.|Day 1 to Day49 for subjects aged ≥4 To ≤8 years not previously vaccinated. Day 1 to Day 38 for subjects aged ≥4 To ≤8 years previously vaccinated and all subjects aged ≥9 To ≤17 years.|Analysis was done on the unsolicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination unsolicited safety data.|||Subjects|||Number
2629983|NCT01857206|Primary|Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.|Day 1 to Day 7 after any vaccination|Analysis was done on the solicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination solicited safety data.|||Subjects|||Number
2629984|NCT01857102|Primary|Visual Comfort|The Visual comfort (diurnal fluctuation[DF]) scores were derived from the National Eye Institute Refractive Error Quality of Life (NEI-RQL) instruments- specifically the diurnal fluctuations sub-scale, by following the instruction given in the NEI-RQL-42 User Manual, Version 1.0. The NEI-RQL is a validated patient reported outcome questionnaire to assess the impact of refractive correction on vision specifically to quality of life. This survey consisted of 42 items used to develop 13 subscales: clarity of vision, expectations, near vision, far vision, diurnal fluctuations, activity limitations, glare, symptoms, dependence on correction, worry, suboptimal correction, appearance, and satisfaction with correction. An overall score is calculated by averaging the subscales. The overall scores can take on values of 0 to 100. Higher scores indicate better outcomes|1-week follow-up|The analysis population consists of all subjects that completed all study visits without a major protocol deviation.|||units on a scale||Standard Deviation|Mean
2629985|NCT01857102|Primary|Objective Comfort Assessed by Electromyography(EMG)|Electromyography (EMG) utilizes electrodes affixed to the skin below the eyelid, which measures activity of the orbital portion of the orbicularis oculi muscle. The orbital portion of the orbicularis oculi muscle pulls on the skin of the forehead, temple and cheek and draws it toward a point at the edge of the orbit. This part of the muscle is mainly under voluntary control, and it what is contracted during the process of squinting. The palpebral portion of this muscle closes the eyelids. The EMG reading was performed while the subject was wearing contact lenses in order to objectively assess eyestrain.The higher the EMG reading indicated the more the eyestrain. The original EMG data collected from a 40-second recording consisted of approximately 40,000 observations; the machine read about 1000 observations per second consecutively during 40-second recording. The original EMG reading was converted to a single data point and entered in the EDC for the analysis purpose.|1 week|Analysis population consists of all subjects that completed all study visits without a major protocol deviation.|||volts||Standard Deviation|Mean
2629986|NCT01857063|Secondary|Change From Baseline in Sneezing Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|The Sneezing Score was assessed as 0 = 0 times participant sneezed to 4 = 21 or more times participant sneezed. The possible Sneezing Score ranged from 0 to 4, with a higher score indicating more severe sneezing. The Sneezing Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
2629987|NCT01857063|Secondary|Change From Baseline in Nasal Discharge Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|The Nasal Discharge Score was assessed as 0 = 0 times participant blew his/her nose to 4 = 21 or more times participant blew his/her nose. The possible Nasal Discharge Score ranged from 0 to 4, with a higher score indicating more severe nasal discharge.The Nasal Discharge Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
2629988|NCT01857063|Secondary|Change From Baseline in Nasal Congestion Score at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|The Nasal Congestion Score was assessed as 0 = No symptoms of nasal congestion to 4 = Completely obstructed all day. The possible Nasal Congestion Score ranged from 0 to 4, with a higher score indicating more severe nasal congestion.The Nasal Congestion Score was assessed on Day 7 prior to entering the chamber room and at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
2629989|NCT01857063|Secondary|Change From Baseline in Weighted TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|TNSS was weighted as 2:1:1 for nasal congestion, nasal discharge and sneezing. The possible Weighted TNSS ranged from 0 to 16, with a higher score indicating more severe total nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Weighted TNSS was assessed on Day 7 of a treatment period at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
2629990|NCT01857063|Secondary|Change From Baseline in TNSS at 30, 60, 90, 120, 150 and 180 Minutes After Entering Chamber Room|The TNSS is the sum of the three nasal symptom scores for nasal congestion, nasal discharge and sneezing. The possible TNSS ranged from 0 to 12, with a higher score indicting more severe total nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period at 30, 60, 90, 120, 150 and 180 minutes after entering the chamber room. Analysis was done by study drug as taken.|Baseline and at 30, 60, 90, 120, 150 and 180 minutes after entering chamber room on Day 7 of a treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
2629991|NCT01857063|Secondary|Change From Baseline in Sneezing Score Averaged During 3 Hours of Exposure|The Sneezing Score was assessed as 0 = 0 times participant sneezed to 4 = 21 or more times participant sneezed, with a possible Sneezing Score ranging from 0 to 4 and a higher score indicating more severe sneezing. The baseline Sneezing Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Sneezing Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
2629992|NCT01857063|Secondary|Change From Baseline in Nasal Discharge Score Averaged During 3 Hours of Exposure|The Nasal Discharge Score was assessed as 0 = 0 times participant blew his/her nose to 4 = 21 or more times participant blew his/her nose, with a possible Nasal Discharge Score ranging from 0 to 4 and a higher score indicating more severe nasal discharge. The baseline Nasal Discharge Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Nasal Discharge Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
2630013|NCT01856790|Other Pre-specified|AUC Plasma Glucagon During MMTT||2 hours||||pg*min/mL||Standard Deviation|Mean
2630014|NCT01856790|Other Pre-specified|Incremental Glucagon Peak||5 hours||||pg/mL/min||Standard Deviation|Mean
2630015|NCT01856790|Other Pre-specified|Mean Daytime Glucose Levels||8a.m.-11p.m.||||mg/dL||Standard Deviation|Mean
2630016|NCT01856790|Other Pre-specified|Mean Time to Peak Post-meal Glucose Value||5- hour postprandial period||||hours||Standard Deviation|Mean
2630017|NCT01856790|Other Pre-specified|Mean 24-hour Glucose Levels||24- hours||||mg/dL||Standard Deviation|Mean
2653316|NCT01644240|Primary|Plasma Vz|Volume of distribution|Day 1||||Liters||Standard Deviation|Mean
2629993|NCT01857063|Secondary|Change From Baseline in Nasal Congestion Score Averaged During 3 Hours of Exposure|The Nasal Congestion Score was assessed as 0 = No symptoms of nasal congestion to 4 = Completely obstructed all day, with a possible Nasal Congestion Score ranging from 0 to 4 and a higher score indicating more severe nasal congestion. The baseline Nasal Congestion Score was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline Nasal Congestion Score was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
2629994|NCT01857063|Secondary|Change From Baseline in Weighted TNSS Averaged During 3 Hours of Exposure|TNSS was weighted as 2:1:1 for nasal congestion, nasal discharge and sneezing. The Weighted TNSS ranged from 0 to 16, with a higher score indicating more severe weighted total nasal symptoms. The baseline Weighted TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period during 3 hours of exposure to JC pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The FAS population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
2629995|NCT01857063|Primary|Percentage of Participants Who Experience at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence adverse events for up to 14 days after last dose of study drug. Analysis was done by study drug as taken.|Up to 5 weeks|The All Patients as Treated (APaT) population consisted of all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
2629996|NCT01857063|Primary|Change From Baseline in Total Nasal Symptom Score (TNSS) Averaged During 3 Hours of Exposure|The TNSS is the sum of the three nasal symptom scores for nasal congestion, nasal discharge and sneezing. Participants completed a questionnaire about their nasal symptoms. Score ranged from 0 to 4 for each of the three nasal symptoms, with a total possible score ranging from 0 to 12 and a higher score indicating more severe nasal symptoms. The baseline TNSS was assessed on Day 7 of a treatment period prior to entering the chamber room. The post-baseline TNSS was assessed on Day 7 of a treatment period during 3 hours of exposure to Japanes cedar (JC) pollen in the chamber room, as an average of measurements at 30, 60, 90, 120, 150 and 180 minutes. Analysis was done by study drug as taken.|Baseline and after 3 hours of pollen exposure on Day 7 of each treatment period|The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study drug, and had a baseline assessment and at least one post-baseline assessment in a treatment period.|||score on a scale||95% Confidence Interval|Least Squares Mean
2629997|NCT01856933|Secondary|Toxicities (Adverse Events) of PSMA ADC for Patients With Recurrent Glioblastoma.||at least every 3 weeks for a maximum of 30 post coming off drug, approximtely 6 months||||Participants|||Count of Participants
2629998|NCT01856933|Primary|Response Rate (Progression) for Patients With Glioblastoma That Have Progressed After Prior Treatment That Has Included Radiation, Temozolomide and Bevacizumab.|"The response assessment in neuro-oncology (RANO) will be used to define radiographic response.~(PD): A >25% increase in tumor area (product of two diameters) OR appearance of a new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer)."|3 months until progression, potentially up to 1 year|Progression|||participants|||Number
2629999|NCT01856907|Other Pre-specified|Liver Enzymes as Safety Measure|Number of patients with no clinically significant changes in liver enzymes-measure of liver enzymes was a study safety endpoint|16 weeks||||Participants|||Count of Participants
2630000|NCT01856907|Secondary|Waist-to-Height Ratio|Measure of central obesity adjusted for stature|16 weeks||||Ratio||Standard Deviation|Mean
2630001|NCT01856907|Secondary|Waist Circumference|Measure of central fat|16 weeks||||centimeters||Standard Deviation|Mean
2630002|NCT01856907|Secondary|Body Mass Index|Measure of body weight corrected by height|16 weeks||||kg/meters^2||Standard Deviation|Mean
2630003|NCT01856907|Secondary|Triglyceride/HDL-Cholesterol Ratio|The ratio of triglyceride to HDL cholesterol is used as an indirect measure of insulin resistance|16 weeks||||Ratio||Standard Deviation|Mean
2630004|NCT01856907|Secondary|Oral Disposition Index|Measure of pancreatic beta cell compensatory action known as IS-SI|16 weeks||||index||Standard Deviation|Mean
2630005|NCT01856907|Secondary|Matsuda Index of Insulin Sensitivity|Composite insulin sensitivity index calculated from from glucose and insulin levels obtained during the OGTT|16 weeks||||index||Standard Deviation|Mean
2630006|NCT01856907|Secondary|Fasting Insulin Resistance|Insulin resistance calculated from fasting glucose and insulin levels known as HOMA-IR|16 weeks||||index||Standard Deviation|Mean
2630007|NCT01856907|Secondary|Mean Blood Glucose Level From the Oral Glucose Tolerance Test (OGTT)|The mean blood glucose is calculated by averaging the 4 blood glucose levels measure during a 75 gm oral glucose tolerance test . This involves summing the glucose levels measured at baseline, and 1/2 hour,1 hour and 2 hours after the glucose load and dividing by 4..|16 weeks||||mg/dL||Standard Deviation|Mean
2630008|NCT01856907|Secondary|Fasting Blood Glucose|Blood glucose in the fasting state|16 weeks||||mg/dL||Standard Deviation|Mean
2630009|NCT01856907|Primary|Normalization of Glucose Levels|Normalization of glucose in patients with abnormal glucose levels is defined as a fasting glucose level of <100 mg/dL and a 2-hour glucose level following a 75 gram oral glucose load of <140 mg/dL|16 weeks||||Participants|||Count of Participants
2630010|NCT01856790|Other Pre-specified|Mean Nocturnal Glucose Levels||11p.m.-6a.m.||||mg/dL||Standard Deviation|Mean
2630011|NCT01856790|Other Pre-specified|Prandial Insulin Delivery During Closed Loop Therapy||Average of the 5-hour post prandial period for breakfast, lunch, dinner combined||||units||Standard Deviation|Mean
2630020|NCT01856764|Secondary|Change From Baseline to Day 15 in Participants' Assessment of Pruritus|Severity of pruritus is assessed by the participants and recorded on a numeric scale ranging from 0 to 10, where 0 indicates the absence of the symptoms and 10 indicates the most severe symptoms.|Baseline and Day 15|All randomized participants who received at least one application of any double-blind study medication with a score at Day 15. One subject in the 0.5% Roflumilast group was missing Day 15 data.|||Scores on a scale||Standard Error|Least Squares Mean
2630021|NCT01856764|Secondary|Change From Baseline to Day 15 in Transepidermal Water Loss (TEWL) Values|Diffusion of water through the skin is measured using a Tewameter. At each visit, 3 measurements are taken per treatment area (at 3 different areas of the target lesion). The TEWL value at each visit is the average of these measurements.|Baseline and Day 15|All randomized participants who received at least one application of any double-blind study medication with a score at Day 15. One subject in the 0.5% Roflumilast group was missing Day 15 data.|||g/m^2/hr||Standard Error|Least Squares Mean
2630022|NCT01856764|Primary|Change From Baseline to Day 15 in Modified Local SCORing Atopic Dermatitis (SCORAD)|Modified Local SCORAD is the sum of 5 individual indexes; erythema, edema/papulation, oozing/crusts, excoriations and lichenification scored on a 4 point scale, where 0=absent and 3=severe, with a total possible score of 15. Higher scores indicate greater severity.|Baseline and Day 15|All randomized participants who received at least one application of any double-blind study medication with a score at Day 15. One subject in the 0.5% Roflumilast group was missing Day 15 data.|||Scores on a scale||Standard Error|Least Squares Mean
2630023|NCT01856712|Secondary|Ongoing Alcohol Consumption|To compare study arms in terms of ongoing alcohol consumption. We hypothesize that (1) improved medication adherence in the oral naltrexone arm and (2) assignment to injectable naltrexone will be associated with reduced alcohol consumption (number of heavy drinking days in the past 14 days) following hospital discharge.|12 months||||Total drinks||Inter-Quartile Range|Mean
2630024|NCT01856712|Secondary|Percentage of Participants Adhered to Medication|Medication adherence was measured as percentage of participants who took ≥ 80% of daily naltrexone doses determined via pill counts. Adherence of daily medication will predict treatment engagement following hospital discharge.|12 months||||Participants|||Count of Participants
2630025|NCT01856712|Secondary|Percentage of Patients Attended Recommended Outpatient Substance Abuse Treatment|Attendance to recommended outpatient substance abuse treatment will be compared between injectable naltrexone group and oral naltrexone group. Keeping patients engaged in treatment is desirable and is known to improve addiction-related outcomes.|12 months||||Participants|||Count of Participants
2630026|NCT01856712|Primary|Retention Rate: Percentage of Participants Attended an Initial Behavioral Treatment Visit Within 2 Weeks of Hospital Discharge.|Retention rate was measured in terms of percentage of participants attended an initial behavioral treatment visit within 2 weeks of hospital discharge.|12 months||||Participants|||Count of Participants
2630027|NCT01856686|Secondary|Inattention Score|Inattention assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 9. Higher values represent a worse outcome.|3 months||||units on a scale||Standard Deviation|Mean
2630028|NCT01856686|Secondary|Impulsivity Score|Impulsivity assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 8. Higher values represent a worse outcome.|3 months||||units on a scale||Standard Deviation|Mean
2630029|NCT01856686|Secondary|Hyperactivity Score|Hyperactivity assessed by clinical questionnaire after 3 months of nutritional approach. Range: minimum value: 0 and maximum value: 8. Higher values represent a worse outcome.|3 months||||units on a scale||Standard Deviation|Mean
2630030|NCT01856686|Other Pre-specified|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Number of Participants with Adverse Events as a Measure of Safety and Tolerability of Brain Proteins Supplements|Up to 8 months||||participants|||Number
2630031|NCT01856686|Other Pre-specified|Body Mass Index at 3 Months|Body mass index after 3 months of dietary approach.|3 months||||kg/m2||Standard Deviation|Mean
2630032|NCT01856686|Secondary|Behavior|"Behavior assessed by total score of clinical questionnaire (sum of Hyperactivity, Impulsivity and Inattention scores), after 3 months of nutritional approach.~Range: minimum value: 0 and maximum value: 25. Higher values represent a worse outcome."|3 months||||units on a scale||Standard Deviation|Mean
2630033|NCT01856686|Primary|Frontal Midline Theta Activity- Amplitude at 3 Months|Frontal midline theta activity- amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months||||microvolts||Standard Deviation|Mean
2630034|NCT01856686|Secondary|Monastra Ratio at 3 Months|Monastra ratio during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months||||ratio||Standard Deviation|Mean
2630035|NCT01856686|Primary|Mu Waves-amplitude at 3 Months|Mu waves-amplitude during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months||||microvolts||Standard Deviation|Mean
2630036|NCT01856686|Secondary|Frontal Midline Theta Activity- Frequency at 3 Months|Frontal midline theta activity- frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months||||Hz||Standard Deviation|Mean
2630037|NCT01856686|Secondary|Mu Wave Frequency at 3 Months|Mu wave frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months||||Hz||Standard Deviation|Mean
2630038|NCT01856686|Other Pre-specified|Weight at 3 Months|Weight after 3 months of dietary approach.|3 months||||kilograms||Standard Deviation|Mean
2630039|NCT01856686|Secondary|Parietal Alpha Waves-frequency at 3 Months|Parietal alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months||||Hz||Standard Deviation|Mean
2630040|NCT01856686|Primary|Occipital Alpha Brainwaves Amplitudes at 3 Months|occipital alpha waves amplitudes during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months||||microvolts||Standard Deviation|Mean
2630041|NCT01856686|Secondary|Occipital Alpha Waves-frequency at 3 Months|occipital alpha waves-frequency during visual continuous performance task from 19 channels EEG recordings, after 3 months of dietary approach.|3 months||||Hz||Standard Deviation|Mean
2630045|NCT01856673|Secondary|Score Difference in Total Mental Health Symptoms (TMHS) and Dysfunction|"TMHS scale of 64 items, ranging from 0 for never to 3 for all the time being the option three the worst condition, including locally relevant symptoms and sub-scales of depression (n=15 symptoms), anxiety (n=10 symptoms) and post-traumatic stress symptoms (PTSS) (n=16 symptoms). Depression and anxiety symptoms were assessed using the Hopkins Symptom Checklist (HSCL-25) and symptoms of trauma (PTSS) were assessed using the Harvard Trauma Questionnaire (HTQ).~The Dysfunction measure was a gender-specific questionnaire with 12-items for females and 10-items for males. Each item assessed a task ranging from 0 for no difficulty to 4 for cannot do it, being the option four the worst condition.~For each scale, the mean was calculated in order to used it as the measure for comparisions.~Mean difference in scores of TMHS and Dysfunction between the subject's baseline and the final assessments according to the study instrument."|Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment.||||units on a scale||95% Confidence Interval|Mean
2630046|NCT01856673|Primary|Score Difference in Symptoms of Anxiety, Depression and Post-traumatic Stress Disorders.|"Symptoms, ranging from 0 for never to 3 for all the time being three the worst score, were assessed with adapted versions of Hopkins Symptom Checklist and Harvard Trauma Questionnaire, from which they were analyzed the constructs of depression (n=15 symptoms), anxiety (n=10 symptoms) and post-traumatic stress symptoms (n=16 symptoms). Depression and anxiety symptoms were assessed using the Hopkins Symptom Checklist (HSCL-25) and symptoms of trauma (PTSS) were assessed using the Harvard Trauma Questionnaire (HTQ).~For each scale, the mean was calculated in order to used it as the measure for comparisions.~Mean difference in scores of symptoms of anxiety, depression and post-traumatic stress disorders between the subject's baseline and the final assessments according to the study instrument."|Within the fifteen (15) days after finishing the intervention, either Common Elements Treatment Approach (CETA) or Narrative Community Group Therapy (NCGT). In the control group, 12 weeks after the baseline assessment.||||units on a scale||95% Confidence Interval|Mean
2630047|NCT01856595|Secondary|Percent Change From Baseline in Lipid Parameters (mg/dL) by Treatment Group on Days 14 and 28 - Part B|Blood samples (3.5 mL) for all lipids and 2 mL for ApoB100 were collected at Hour 0 Day 1, Day 7 prior to breakfast, Hour 0 Day 14 for all cohorts; Days 21 and 28 for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B.|Days 0,14 and 28|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||Percentage of change||Standard Deviation|Mean
2630048|NCT01856595|Secondary|Percent Change From Baseline in Lipid Parameters (mg/dL) by Treatment Group on Days 14 and 28 - Part A|Blood samples (3.5 mL) for all lipids and 2 mL for ApoB100 were collected at Hour 0 Day 1, Day 7 prior to breakfast, Hour 0 Day 14 for all cohorts; Days 21 and 28 for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B.|Days 0,14 and 28|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||percentage of change||Standard Deviation|Mean
2630049|NCT01856595|Secondary|Absolute Values and Changes From Baseline in Fasting Plasma Insulin at Days 14 and 28 - Part B|Fasting blood insulin samples were collected on Days -1, 14 and 28 for all cohorts, and on Day 28 for PF-06291874 30 mg Part B. Baseline was defined as the value on Day -1.|Days -1, 14, 28|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||µIU/mL||Standard Deviation|Mean
2630050|NCT01856595|Secondary|Absolute Values and Changes From Baseline in Fasting Plasma Insulin at Days 14 and 28 - Part A|Fasting blood insulin samples were collected on Days -1, 14 and 28 for all cohorts, and on Day 28 for PF-06291874 100 mg Part A. Baseline was defined as the value on Day -1.|Days -1, 14, 28|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||µIU/mL||Standard Deviation|Mean
2630051|NCT01856595|Secondary|Absolute Values and Changes From Baseline in Fasting Plasma Glucose at Days 2, 7, 14, 15, 21, 28 and 29 - Part B|Fasting blood glucose samples were also collected on Days 0, 2, 7, and 15 for all cohorts, and on Days 21 and 29 for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B.|Days 0,2,7,14,15,21,28,29|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||mg/dL||Standard Deviation|Mean
2630052|NCT01856595|Secondary|Absolute Values and Changes From Baseline in Fasting Plasma Glucose at at Days 2, 7, 14, 15, 21, 28 and 29 - Part A|Fasting blood glucose samples were also collected on Days 0, 2, 7, and 15 for all cohorts, and on Days 21 and 29 for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B.|predose on Days 0,2,7,14,15,21,28,29|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||mg/dL||Standard Deviation|Mean
2630078|NCT01856595|Primary|Multiple Dose Cmin (Lowest Plasma Concentration Observed During the Dosing Interval) for PF-06291874 - Part A|Cmin was the lowest plasma concentration observed during the dosing interval. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19, 24 hours post dose.|Predose (0), 2, 4, 6, 8, 12, 19, 24 hours post dose on Day 14|This PK Parameter Analysis Set was defined as all participants randomized and treated who have at least 1 of the PK parameters of interest. The number of participants analyzed was the number of participants contributing to the summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2630053|NCT01856595|Secondary|Changes Relative to Baseline (Ratio) of AUC0-4 for C-Peptide Following MMTT on Day 28|Blood samples for analysis of insulin, C-peptide, glucagon and GLP-1 were collected at nominal time 0, 0.25, 0.5, 1, 1.5, 2, 3, 4 hours on Days -1 and 14 for all cohorts, and on Day 28 and follow-up visit for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B. AUC0-4 and natural log transformed AUC0-4 were calculated for each day.|0, 0.25, 0.5, 1, 1.5, 2, 3, 4 hours on Days -1 and 14 for all cohorts, and on Day 28 and follow-up visit for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B.|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||Ratio||90% Confidence Interval|Least Squares Mean
2630054|NCT01856595|Secondary|Changes Relative to Baseline (Ratio) of AUC0-4 for C-Peptide Following MMTT on Day 14 - Part B|Blood samples for analysis of insulin, C-peptide, glucagon and GLP-1 were collected at nominal time 0, 0.25, 0.5, 1, 1.5, 2, 3, 4 hours on Days -1 and 14 for all cohorts, and on Day 28 and follow-up visit for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B. AUC0-4 and natural log transformed AUC0-4 were calculated for each day.|0, 0.25, 0.5, 1, 1.5, 2, 3, 4 hours on Days -1 and 14 for all cohorts, and on Day 28 and follow-up visit for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B.|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||Ratio||90% Confidence Interval|Least Squares Mean
2630055|NCT01856595|Secondary|Changes Relative to Baseline (Ratio) of AUC0-4 for C-Peptide Following MMTT on Day 14 - Part A|Blood samples for analysis of insulin, C-peptide, glucagon and GLP-1 were collected at nominal time 0, 0.25, 0.5, 1, 1.5, 2, 3, 4 hours on Days -1 and 14 for all cohorts, and on Day 28 and follow-up visit for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B. AUC0-4 and natural log transformed AUC0-4 were calculated for each day.|0, 0.25, 0.5, 1, 1.5, 2, 3, 4 hours on Days -1 and 14 for all cohorts, and on Day 28 and follow-up visit for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B.|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||ratio||90% Confidence Interval|Least Squares Mean
2630056|NCT01856595|Secondary|Changes Relative to Baseline (Ratio) of AUC0-4 for Insulin Following MMTT on Day 28|Blood samples for analysis of insulin, C-peptide, glucagon and GLP-1 were collected at nominal time 0, 0.25, 0.5, 1, 1.5, 2, 3, 4 hours on Days -1 and 14 for all cohorts, and on Day 28 and follow-up visit for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B. AUC0-4 and natural log transformed AUC0-4 were calculated for each day.|0, 0.25, 0.5, 1, 1.5, 2, 3, 4 hours on Days -1 and 14 for all cohorts, and on Day 28 and follow-up visit for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B.|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||Ratio||90% Confidence Interval|Least Squares Mean
2630057|NCT01856595|Secondary|Changes Relative to Baseline (Ratio) of AUC0-4 for Insulin Following MMTT on Day 14 - Part B|Blood samples for analysis of insulin, C-peptide, glucagon and GLP-1 were collected at nominal time 0, 0.25, 0.5, 1, 1.5, 2, 3, 4 hours on Days -1 and 14 for all cohorts, and on Day 28 and follow-up visit for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B. AUC0-4 and natural log transformed AUC0-4 were calculated for each day.|0, 0.25, 0.5, 1, 1.5, 2, 3, 4 hours on Days -1 and 14 for all cohorts, and on Day 28 and follow-up visit for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B.|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||Ratio||90% Confidence Interval|Least Squares Mean
2630058|NCT01856595|Secondary|Changes Relative to Baseline (Ratio) of AUC0-4 for Insulin Following MMTT on Day 14 - Part A|Blood samples for analysis of insulin, C-peptide, glucagon and GLP-1 were collected at nominal time 0, 0.25, 0.5, 1, 1.5, 2, 3, 4 hours on Days -1 and 14 for all cohorts, and on Day 28 and follow-up visit for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B. AUC0-4 and natural log transformed AUC0-4 were calculated for each day.|0, 0.25, 0.5, 1, 1.5, 2, 3, 4 hours on Days -1 and 14 for all cohorts, and on Day 28 and follow-up visit for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B.|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. The number of participants analyzed was the number of participants contributing to the summary statistics.|||ratio||90% Confidence Interval|Least Squares Mean
2630059|NCT01856595|Secondary|Percent Changes From Baseline of AUC0-4 for Glucagon Following MMTT on Day 28|Blood samples for analysis of insulin, C-peptide, glucagon and GLP-1 were collected at nominal time 0, 0.25, 0.5, 1, 1.5, 2, 3, 4 hours on Days -1 and 14 for all cohorts, and on Day 28 and follow-up visit for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B. AUC0-4 and natural log transformed AUC0-4 were calculated for each day.|0, 0.25, 0.5, 1, 1.5, 2, 3, 4 hours on Days -1 and 14 for all cohorts, and on Day 28 and follow-up visit for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B.|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||Percentage of change||Standard Deviation|Mean
2630079|NCT01856595|Primary|Multiple Dose Half Life for PF-06291874|Plasma half-life was the time measured for the plasma concentration to decrease by one half. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19, 24 hours post dose.|Predose (0), 2, 4, 6, 8, 12, 19, 24 hours post dose on Day 14|This PK Parameter Analysis Set was defined as all participants randomized and treated who have at least 1 of the PK parameters of interest. The number of participants analyzed was the number of participants contributing to the summary statistics. This parameter was not calculated for group: 100 mg Part A, 30 mg Part B.|||hr||Standard Deviation|Mean
2630060|NCT01856595|Secondary|Percent Changes From Baseline of AUC0-4 for Glucagon Following MMTT on Day 14 - Part B|Blood samples for analysis of insulin, C-peptide, glucagon and glucagon-like peptide 1 (GLP-1) were collected at nominal time 0, 0.25, 0.5, 1, 1.5, 2, 3, 4 hours on Days -1 and 14 for all cohorts, and on Day 28 and follow-up visit for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B. AUC0-4 and natural log transformed AUC0-4 were calculated for each day.|0, 0.25, 0.5, 1, 1.5, 2, 3, 4 hours on Days -1 and 14 for all cohorts, and on Day 28 and follow-up visit for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B.|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||Percentage of change||Standard Deviation|Mean
2630061|NCT01856595|Secondary|Percent Changes From Baseline of AUC0-4 for Glucagon Following MMTT on Day 14 - Part A|Blood samples for analysis of insulin, C-peptide, glucagon and glucagon-like peptide 1 (GLP-1) were collected at nominal time 0, 0.25, 0.5, 1, 1.5, 2, 3, 4 hours on Days -1 and 14 for all cohorts, and on Day 28 and follow-up visit for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B. AUC0-4 and natural log transformed AUC0-4 were calculated for each day.|0, 0.25, 0.5, 1, 1.5, 2, 3, 4 hours on Days -1 and 14 for all cohorts, and on Day 28 and follow-up visit for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B.|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||Percentage of change||Standard Deviation|Mean
2630062|NCT01856595|Secondary|Changes Relative to Baseline (Ratio) of AUC0-4 for Glucose Following MMTT on Day 28|Blood samples for analysis of glucose were collected at nominal time 0, 0.25, 0.5, 1, 1.5, 2, 3, and 4 hours on Days -1 and 14 for all cohorts, and on Day 28 for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B. AUC0-4 and natural log transformed AUC0-4 were calculated for each day.|0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 10, 12, 15, and 19 hours on Days -1 and 14 for all cohorts, and on Day 28 for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B.|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||ratio||90% Confidence Interval|Least Squares Mean
2630063|NCT01856595|Secondary|Changes Relative to Baseline (Ratio) of AUC0-4 for Glucose Following MMTT on Day 14 - Part B|Blood samples for analysis of glucose were collected at nominal time 0, 0.25, 0.5, 1, 1.5, 2, 3, and 4 hours on Days -1 and 14 for all cohorts, and on Day 28 for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B. AUC0-4 and natural log transformed AUC0-4 were calculated for each day.|0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 10, 12, 15, and 19 hours on Days -1 and 14 for all cohorts, and on Day 28 for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B.|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||ratio||90% Confidence Interval|Least Squares Mean
2630064|NCT01856595|Secondary|Changes Relative to Baseline (Ratio) of AUC0-4 for Glucose Following MMTT on Day 14 - Part A|Blood samples for analysis of glucose were collected at nominal time 0, 0.25, 0.5, 1, 1.5, 2, 3, and 4 hours on Days -1 and 14 for all cohorts, and on Day 28 for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B. AUC0-4 and natural log transformed AUC0-4 were calculated for each day.|0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 10, 12, 15, and 19 hours on Days -1 and 14 for all cohorts, and on Day 28 for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B.|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||ratio||90% Confidence Interval|Least Squares Mean
2630065|NCT01856595|Primary|Changes From Baseline for Mean Daily Glucose (mg/dL) on Day 28 (AUC Approach)|A MMTT was administered on Days -1 for all cohorts, and on Day 28 for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B. Blood samples for analysis of glucose were collected at nominal time 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 10, 12, 15, 19 and 24 hours on Days -1 and 14 for all cohorts, and on Day 28 for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B. MDG was computed by AUC24/24 hours of the glucose values measured.|0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 10, 12, 15, 19 and 24 hours on Days -1 and 14 for all cohorts, and on Day 28 for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B.|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||mg/dL||90% Confidence Interval|Least Squares Mean
2630066|NCT01856595|Primary|Changes From Baseline for Mean Daily Glucose (mg/dL) on Day 14 (AUC Approach) - Part B|A MMTT was administered on Days -1 and 14 for all cohorts. Blood samples for analysis of glucose were collected at nominal time 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 10, 12, 15, 19 and 24 hours on Days -1 and 14 for all cohorts. MDG was computed by AUC24/24 hours of the glucose values measured.|0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 10, 12, 15, 19 and 24 hours on Days -1 and 14 for all cohorts, and on Day 28 for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B.|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||ng/mL||90% Confidence Interval|Least Squares Mean
2630080|NCT01856595|Primary|Multiple Dose AUCtau for PF-06291874 - Part B|AUCtau was area under the concentration-time profile from time zero to time tau, the dosing interval, where tau = 24 hours. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19, 24 hours post dose.|Predose (0), 2, 4, 6, 8, 12, 19, 24 hours post dose on Day 14|This PK Parameter Analysis Set was defined as all participants randomized and treated who have at least 1 of the PK parameters of interest.|||ng.hr/mL||Geometric Coefficient of Variation|Geometric Mean
2630067|NCT01856595|Primary|Changes From Baseline for Mean Daily Glucose (mg/dL) on Day 14 (AUC Approach) - Part A|A MMTT was administered on Days -1 and 14 for all cohorts. Blood samples for analysis of glucose were collected at nominal time 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 10, 12, 15, 19 and 24 hours on Days -1 and 14 for all cohorts. MDG was computed by AUC24/24 hours of the glucose values measured.|0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 10, 12, 15, 19 and 24 hours on Days -1 and 14 for all cohorts, and on Day 28 for PF-06291874 100 mg Part A and PF-06291874 30 mg Part B.|All subjects administered PF-06291874 or placebo were included in PD analysis. Placebo subjects within each cohort in Part A or B were pooled into a single placebo group for the inpatient portion of the study. Data collected from placebo subjects during the outpatient portion of study (Day 28) were also pooled separately for Parts A and B.|||mg/dL||90% Confidence Interval|Least Squares Mean
2630068|NCT01856595|Primary|Multiple Dose Renal Clearance (CLr) for PF-06291874|CLr was renal clearance. The 24 hour urine samples for PK analysis were collected on Day 14 over 2 collection periods (0-6 hours and 6-24 hours)|on Day 14 over 2 collection periods (0-6 hours and 6-24 hours).|This PK Parameter Analysis Set was defined as all participants randomized and treated who have at least 1 of the PK parameters of interest. For treatment groups with dose< 50 mg, all urine concentrations were below the lower limit of quantification (<50.0 ng/mL) and hence no urine parameter was calculated including CLr.|||mL/hr||Full Range|Median
2630069|NCT01856595|Primary|Multiple Dose Percent of Cumulative Amount of Drug Recovered Unchanged in Urine Over the Dosing Interval τ(Aetau%) for PF-06291874|Aetau% was percent of cumulative amount of drug recovered unchanged in urine over the dosing interval τ. The 24-hour urine samples for PK analysis were collected on Day 14 over 2 collection periods (0-6 hours and 6-24 hours).|on Day 14 over 2 collection periods (0-6 hours and 6-24 hours).|This PK Parameter Analysis Set was defined as all participants randomized and treated who have at least 1 of the PK parameters of interest. For treatment groups with dose< 50 mg, all urine concentrations were below the lower limit of quantification (<50.0 ng/mL) and hence no urine parameter was calculated including Aetau%.|||percentage of dose||Full Range|Median
2630070|NCT01856595|Primary|Multiple Dose Rac,Cmax for PF-06291874 - Part B|Rac,cmax was observed accumulation ratio for Cmax. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19, 24 hours post dose.|Predose (0), 2, 4, 6, 8, 12, 19, 24 hours post dose on Day 14|This PK Parameter Analysis Set was defined as all participants randomized and treated who have at least 1 of the PK parameters of interest.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2630071|NCT01856595|Primary|Multiple Dose Rac for Cmax (Rac,Cmax) for PF-06291874 - Part A|Rac,cmax was observed accumulation ratio for Cmax. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19, 24 hours post dose.|Predose (0), 2, 4, 6, 8, 12, 19, 24 hours post dose on Day 14|This PK Parameter Analysis Set was defined as all participants randomized and treated who have at least 1 of the PK parameters of interest. The number of participants analyzed was the number of participants contributing to the summary statistics.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2630072|NCT01856595|Primary|Multiple Dose Rac for PF-06291874 - Part B|Rac was observed accumulation ratio. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19, 24 hours post dose.|Predose (0), 2, 4, 6, 8, 12, 19, 24 hours post dose on Day 14|This PK Parameter Analysis Set was defined as all participants randomized and treated who have at least 1 of the PK parameters of interest.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2630073|NCT01856595|Primary|Multiple Dose Observed Accumulation Ratio (Rac) for PF-06291874 - Part A|Rac was observed accumulation ratio. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19, 24 hours post dose.|Predose (0), 2, 4, 6, 8, 12, 19, 24 hours post dose on Day 14|This PK Parameter Analysis Set was defined as all participants randomized and treated who have at least 1 of the PK parameters of interest. The number of participants analyzed was the number of participants contributing to the summary statistics.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2630074|NCT01856595|Primary|Multiple Dose Apparent Volume of Distribution (Vz/F) for PF-06291874- Part A and Part B|Vz/F was apparent volume of distribution. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19, 24 hours post dose.|Predose (0), 2, 4, 6, 8, 12, 19, 24 hours post dose on Day 14|This PK Parameter Analysis Set was defined as all participants randomized and treated who have at least 1 of the PK parameters of interest. This parameter was not calculated for treatment groups with only 24-hour sampling on Day 14(A: 100 mg and B: 30 mg), since the terminal phase was not well characterized.|||L||Geometric Coefficient of Variation|Geometric Mean
2630075|NCT01856595|Primary|Multiple Dose CL/F for PF-06291874 - Part B|CL/F was multiple dose apparent clearance. The 24-hour urine samples for PK analysis were collected on Day 14 over 2 collection periods (0-6 hours and 6-24 hours).|on Day 14 over 2 collection periods (0-6 hours and 6-24 hours).|This PK Parameter Analysis Set was defined as all participants randomized and treated who have at least 1 of the PK parameters of interest.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2630076|NCT01856595|Primary|Multiple Dose Apparent Clearance (CL/F) for PF-06291874 - Part A|CL/F was multiple dose apparent clearance. The 24-hour urine samples for PK analysis were collected on Day 14 over 2 collection periods (0-6 hours and 6-24 hours).|on Day 14 over 2 collection periods (0-6 hours and 6-24 hours).|This PK Parameter Analysis Set was defined as all participants randomized and treated who have at least 1 of the PK parameters of interest. The number of participants analyzed was the number of participants contributing to the summary statistics.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2630077|NCT01856595|Primary|Multiple Dose Cmin for PF-06291874 - Part B|Cmin was the lowest plasma concentration observed during the dosing interval. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19, 24 hours post dose.|Predose (0), 2, 4, 6, 8, 12, 19, 24 hours post dose on Day 14|This PK Parameter Analysis Set was defined as all participants randomized and treated who have at least 1 of the PK parameters of interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2630399|NCT01854593|Secondary|Postoperative Best Corrected Visual Acuity|"Best corrected visual acuity was measured using the Landolt ring chart, and the result was converted to logMAR notation for analysis.~The minimum of the scale is 2.0 and the maximum of the scale is -0.3. The higher values represent a worse outcome."|1 mouth after surgery.||||LogMAR||Standard Deviation|Mean
2630081|NCT01856595|Primary|Multiple Dose AUCtau for PF-06291874 - Part A|AUCtau was area under the concentration-time profile from time zero to time tau, the dosing interval, where tau = 24 hours. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19, 24 hours post dose.|Predose (0), 2, 4, 6, 8, 12, 19, 24 hours post dose on Day 14|This PK Parameter Analysis Set was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest. The number of participants analyzed was the number of participants contributing to the summary statistics.|||ng.hr/mL||Geometric Coefficient of Variation|Geometric Mean
2630082|NCT01856595|Primary|Multiple Dose Tmax for PF-06291874 - Part B|Tmax was time at which Cmax occurred. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19, 24 hours post dose.|Predose (0), 2, 4, 6, 8, 12, 19, 24 hours post dose on Day 14|This PK Parameter Analysis Set was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest.|||hr||Full Range|Median
2630083|NCT01856595|Primary|Multiple Dose Tmax for PF-06291874 - Part A|Tmax was time at which Cmax occurred. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19, 24 hours post dose.|Predose (0), 2, 4, 6, 8, 12, 19, 24 hours post dose on Day 14|This PK Parameter Analysis Set was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest. The number of participants analyzed was the number of participants contributing to the summary statistics.|||hour||Full Range|Median
2630084|NCT01856595|Primary|Multiple Dose Cmax for PF-06291874 - Part B|Cmax was maximum plasma concentration. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19, 24 hours post dose.|Predose (0), 2, 4, 6, 8, 12, 19, 24 hours post dose on Day 14|This PK Parameter Analysis Set was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2630085|NCT01856595|Primary|Multiple Dose Cmax for PF-06291874 - Part A|Cmax was maximum plasma concentration. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19, 24 hours post dose.|Predose (0), 2, 4, 6, 8, 12, 19, 24 hours post dose on Day 14|This PK Parameter Analysis Set was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest. The number of participants analyzed was the number of participants contributing to the summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2630086|NCT01856595|Primary|Single Dose AUCtau for PF-06291874 - Part B|AUCtau was area under the concentration-time profile from time zero to time tau, the dosing interval, where tau = 24 hours. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19, 24 hours post dose.|0 hour (pre-dose), 2, 4, 6, 8, 12, 19, 24 hours post-dose on Day 1|This PK Parameter Analysis Set was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest.|||ng.hr/mL||Geometric Coefficient of Variation|Geometric Mean
2630087|NCT01856595|Primary|Single Dose AUCtau (Area Under the Concentration-time Profile From Time Zero to Time Tau, the Dosing Interval, Where Tau = 24 Hours) for PF-06291874 - Part A|AUCtau was area under the concentration-time profile from time zero to time tau, the dosing interval, where tau = 24 hours. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19, 24 hours post dose.|0 hour (pre-dose), 2, 4, 6, 8, 12, 19, 24 hours post-dose on Day 1|This PK Parameter Analysis Set was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest.|||ng.hr/mL||Geometric Coefficient of Variation|Geometric Mean
2630088|NCT01856595|Primary|Single Dose Tmax for PF-06291874 - Part B|Tmax was time at which Cmax occurred. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19, 24 hours post dose.|0 hour (pre-dose), 2, 4, 6, 8, 12, 19, 24 hours post-dose on Day 1|This PK Parameter Analysis Set was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest.|||hr||Full Range|Median
2630089|NCT01856595|Primary|Single Dose Time at Which Cmax Occurred (Tmax) for PF-06291874 - Part A|Tmax was time at which Cmax occurred. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19, 24 hours post dose.|0 hour (pre-dose), 2, 4, 6, 8, 12, 19, 24 hours post-dose on Day 1|This PK Parameter Analysis Set was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest.|||hr||Full Range|Median
2630090|NCT01856595|Primary|Single Dose Normalized Cmax (Cmax[dn]) for PF-06291874 - Part B|Cmax (dn) was dose normalized maximum plasma concentration. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19 and 24 hours post dose|0 hour (pre-dose), 2, 4, 6, 8, 12, 19, 24 hours post-dose on Day 1|This PK Parameter Analysis Set was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest.|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2630091|NCT01856595|Primary|Single Dose Cmax for PF-06291874 - Part B|Cmax was maximum plasma concentration. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for PK analysis were collected at 0, 2, 4, 6, 8, 12, 19 and 24 hours post dose.|0 hour (pre-dose), 2, 4, 6, 8, 12, 19, 24 hours post-dose on Day 1|This PK Parameter Analysis Set was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2630092|NCT01856595|Primary|Single Dose Normalized Cmax (Cmax[dn]) for PF-06291874 - Part A|Cmax (dn) was dose normalized maximum plasma concentration. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for pharmacokinetic (PK) analysis were collected at 0, 2, 4, 6, 8, 12, 19 and 24 hours post dose.|0 hour (pre-dose), 2, 4, 6, 8, 12, 19, 24 hours post-dose on Day 1|This PK Parameter Analysis Set was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest|||ng/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2630093|NCT01856595|Primary|Single Dose Maximum Plasma Concentration (Cmax) for PF-06291874 - Part A|Cmax was maximum plasma concentration. Blood samples (3 mL) to provide a minimum of approximately 1.2 mL plasma for pharmacokinetic (PK) analysis were collected at 0, 2, 4, 6, 8, 12, 19 and 24 hours post dose.|0 hour (pre-dose), 2, 4, 6, 8, 12, 19, 24 hours post-dose on Day 1|This PK Parameter Analysis Set was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2630094|NCT01856595|Primary|Number of Participants With Any Abnormal Laboratory Test Results - Part B|The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, MCV, MCH, MCHC, platelets, white blood cell count, absolute lymphocytes, absolute total neutrophils, absolute basophils, absolute eosinophils and absolute monocytes), coagulation (PPT, prothrombin), liver function(total bilirubin, AST, ALT, alkaline phosphatase, total protein and albumin), renal function (blood urea nitrogen, creatinine, uric acid), Lipids (cholesterol, HDL cholesterol, LDL cholesterol, triglycerides), Electrolytes (sodium, potassium, chloride, calcium, venous bicarbonate), clinical chemistry (glucose, glycosylated, hemoglobin, amylase, lipase), urinalysis dipstick (urine PH, urine glucose, urine ketones, urine protein, urine urobilinogen, urine bilirubin, urine nitrite, urine leukocyte, esterase), urinalysis microscopy (urine RBC, urine WBC, urine bacteria). Laboratory abnormality was determined by the investigator based on pre-defined criteria.|Predose on Days 0,3,7,11 for all cohorts and 14 and 17 for Cohorts 1- 4A and 1B, and pre-dose on Days 21 and 28 for Cohorts 5A and 2B.|The Safety Analysis Set was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
2630095|NCT01856595|Primary|Number of Participants With Any Abnormal Laboratory Test Results - Part A|The laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, MCV, MCH, MCHC, platelets, white blood cell count, absolute lymphocytes, absolute total neutrophils, absolute basophils, absolute eosinophils and absolute monocytes), coagulation (PPT, prothrombin), liver function(total bilirubin, AST, ALT, alkaline phosphatase, total protein and albumin), renal function (blood urea nitrogen, creatinine, uric acid), Lipids (cholesterol, HDL cholesterol, LDL cholesterol, triglycerides), Electrolytes (sodium, potassium, chloride, calcium, venous bicarbonate), clinical chemistry (glucose, glycosylated, hemoglobin, amylase, lipase), urinalysis dipstick (urine PH, urine glucose, urine ketones, urine protein, urine urobilinogen, urine bilirubin, urine nitrite, urine leukocyte, esterase), urinalysis microscopy (urine RBC, urine WBC, urine bacteria). Laboratory abnormality was determined by the investigator based on pre-defined criteria.|Predose on Days 0,3,7,11 for all cohorts and 14 and 17 for Cohorts 1- 4A and 1B, and pre-dose on Days 21 and 28 for Cohorts 5A and 2B.|The Safety Analysis Set was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
2630096|NCT01856595|Primary|Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern - Part B|Vital signs included blood pressure (BP; supine, sitting and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: SBP >= 30 mm Hg change from grand baseline in same posture, SBP < 90 mm Hg; DBP >=20 mm Hg change from grand baseline in same posture, DBP<50 mm Hg; 2), pulse rate (supine): <40 or > 120 bpm.|Predose (0),4,6,8,12,24 hours on Days 1 and 14; 8 hours post dose on Days 3,7,11 for all Cohorts ; predose on Day 17 for Cohorts 1- 4A and 1B; predose on Days 21 and 28 for Cohorts 5A and 2B.|The Safety Analysis Set was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
2630097|NCT01856595|Primary|Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern - Part A|Vital signs included blood pressure (BP; supine, sitting and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic BP (SBP) greater than or equal to (>=) 30 millimeters of mercury (mm Hg) change from grand baseline in same posture, systolic less than (<) 90 mm Hg; diastolic BP (DBP) >=20 mm Hg change from grand baseline in same posture, diastolic <50 mm Hg; 2), pulse rate (supine): <40 or greater than (>) 120 beats per minute (bpm).|Predose (0),4,6,8,12,24 hours on Days 1 and 14; 8 hours post dose on Days 3,7,11 for all Cohorts ; predose on Day 17 for Cohorts 1- 4A and 1B; predose on Days 21 and 28 for Cohorts 5A and 2B.|The Safety Analysis Set was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
2630098|NCT01856595|Primary|Number of Participants With ECGs Data Met Criteria of Potential Clinical Concern - Part B|ECG criteria of potential clinical concern were 1), PR interval: >=300 msec; >=25% increase when baseline >200 msec; or increase >=50% when baseline <=200 msec; 2), QRS interval: >=140 msec; >=50% increase from baseline; 3), QT interval: >=500 msec, QTcF interval: absolute value >=450 - <480 msec, >=480-<500 msec, >500 msec; absolute change 30 - <60, >=60 msec.|Predose (0),4,6,8,12,24 hours on Days 1 and 14; 8 hours post dose on Days 3,7,11 for all Cohorts ; predose on Day 17 for Cohorts 1- 4A and 1B; predose on Days 21 and 28 for Cohorts 5A and 2B.|The Safety Analysis Set was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
2630099|NCT01856595|Primary|Number of Participants With Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern - Part A|ECG criteria of potential clinical concern were 1), PR interval: greater than or equal to (>=)300 milliseconds (msec); >=25 percent (%) increase when baselinegreater than (>)200 msec; or increase >=50% when baseline less than or equal to (<=)200 msec; 2), QRS interval: >=140 msec; >=50% increase from baseline; 3), QT interval: >=500 msec, QTc interval using cridericia's formula (QTcF interval): absolute value >=450 - <480 msec, >=480-<500 msec, >500 msec; absolute change 30 - <60, >=60 msec.|Predose (0),4,6,8,12,24 hours on Days 1 and 14; 8 hours post dose on Days 3,7,11 for all Cohorts ; predose on Day 17 for Cohorts 1- 4A and 1B; predose on Days 21 and 28 for Cohorts 5A and 2B.|The Safety Analysis Set was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
2630100|NCT01856595|Primary|Number of Participants Had Protocol-Defined Total Hypoglycemic Adverse Event (HAE) - Part B|A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. Hypoglycaemia was assessed and reported in several categories: severe hypoglycaemia, documented symptomatic hypoglycaemia, asymptomatic hypoglycaemia, and probable hypoglycaemia.|Day 1 up to 7-11 days after last dose of study drug|The Safety Analysis Set was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
2630101|NCT01856595|Primary|Number of Participants Had Protocol-Defined Total Hypoglycemic Adverse Event (HAE) - Part A|A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. Hypoglycaemia was assessed and reported in several categories: severe hypoglycaemia, documented symptomatic hypoglycaemia, asymptomatic hypoglycaemia, and probable hypoglycaemia.|Day 1 up to 7-11 days after last dose of study drug|The Safety Analysis Set was defined as all participants who received at least 1 dose of study medication.|||participants|||Number
2630102|NCT01856582|Primary|Number of Participants Who Showed Successful Augmentation of Graft Function|Successful augmentation of graft function achieved if donor chimerism is doubled compared to the value immediately pre-infusion at 12 months.|12 months|Selected data from this study was combined with a clinical retrospective study for analysis and published.|||Participants|||Count of Participants
2630103|NCT01856569|Secondary|Erythrocyte Sedimentation Rate at Baseline|Erythrocyte sedimentation rate was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in millimeter per hour (mm/h).|Baseline|FAS included all participants who met the inclusion criteria.|||millimeter per hour||Standard Deviation|Mean
2630104|NCT01856569|Secondary|C Reactive Protein Level at Baseline|C reactive protein was measured from blood samples as a marker for inflammation. Higher levels were indicative of more inflammation.|Baseline|FAS included all participants who met the inclusion criteria. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.|||milligram per liter||Standard Deviation|Mean
2630105|NCT01856569|Secondary|Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18|ASQoL was a disease-specific questionnaire that assessed the impact of AS on participant's quality of life (QoL). It consisted of 18 questions to be completed by the participant. Each question was answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). Scores of each individual question was summed to give a total score that ranges from 0 (good QoL) to 18 (poor QoL), where lower scores indicated good quality of life. Data for this outcome was planned to be reported separately for switchers (participants who switched to a second anti-TNF drug during observation period) and non-switchers (participants who did not switched to a second anti-TNF drug during observation period).|Month 18|"FAS included all participants who met the inclusion criteria. Here, n signifies number of participants evaluable each specified category."|||units on a scale||Standard Deviation|Mean
2630106|NCT01856569|Primary|Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity|Low disease activity was defined as a BASDAI score of less than or equal to (<=) 2. BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity. In this outcome, percentage of participants with unchanged first line anti-TNF drug (nor dose neither frequency, but drug only) in the state of low disease activity, during the specified time points were reported.|Month 12, 18|"FAS included all participants who met the inclusion criteria. Here, n signifies number of participants evaluable for each time point."|||percentage of participants|||Number
2630107|NCT01856569|Primary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 18|BASDAI was a validated self-assessment tool used to determine disease activity in participants with AS. Utilizing a numerical rating scale (NRS) of 0-10 (0 = no problem to 10 = worst problem) participants answered 6 questions measuring symptoms of AS (spinal pain, fatigue, joint pain or swelling, areas of localized tenderness, morning stiffness duration and severity). The BASDAI total score was calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score was then divided by 5. BASDAI=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The total BASDAI score ranges from 0=none to 10=severe, where lower score indicated less disease activity.|Baseline, Month 18|FAS included all participants who met the inclusion criteria. Here, number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2630108|NCT01856569|Primary|Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18|First line anti-TNF treatment included adalimumab, etanercept, golimumab and infliximab. In this outcome, percentage of participants who were taking any one of the first line anti-TNF treatment at baseline and maintained the same up to Month 18 without any change in prescription, were reported.|Baseline up to Month 18|FAS included all participants who met the inclusion criteria.|||percentage of participants|||Number
2630109|NCT01856543|Secondary|Difference Between Patient-reported Skin Toxicities at End of Radiation Therapy and 2 Week Follow-up|The Skindex-16 assessment tool is designed to capture patient-reported assessments of subjective adverse effects. It consists of a short 16-item assessment completed by the patient, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Responses to the Skindex-16 are categorized into three subscales: symptom, emotional, and functional. Scores for the emotions, symptoms and functioning scales are also expressed in a linear scale from 0 to 100. Rankings of the questionnaire are then averaged to obtain a score of severity of patient-reported outcomes. This allows providers to gauge which aspects of the participant's experience are most affected by the treatment.|2 weeks after end of Radiation Therapy||||scores on a scale||Standard Deviation|Median
2630110|NCT01856543|Secondary|Difference From Baseline and 5 Weeks Between Patient-reported Skin Toxicities at Baseline and End of Radiation Treatment|The Skindex-16 assessment tool is designed to capture patient-reported assessments of subjective adverse effects. It consists of a short 16-item assessment completed by the patient, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Responses to the Skindex-16 are categorized into three subscales: symptom, emotional, and functional. Scores for the emotions, symptoms and functioning scales are also expressed in a linear scale from 0 to 100. Rankings of the questionnaire are then averaged to obtain a score of severity of patient-reported outcomes. This allows providers to gauge which aspects of the participant's experience are most affected by the treatment.|5 weeks and Baseline||||score on a scale||Standard Deviation|Median
2630111|NCT01856543|Primary|Percentage of Participants With Moist Desquamation|Skin toxicity assessments will be done on a weekly basis while the patient is receiving RT, by the RN or physician utilizing CTCAE 4.0 and the weekly status check form, as per current standard practice.|2 years||||% of participants w/moist desquamation|||Number
2630112|NCT01856530|Secondary|Perceived Rejection Scores on a 1-7 Likert Scale|Participants will rate their level of perceived rejection (on a 1-7 Likert scale) from Player 1 during online ball-tossing task. Higher scores on this scale reflect greater perceived rejection from Player 1.|Day 1 (first day oxytocin or placebo was administered)|Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in this analysis. Thus, only 52 participants were included in this analysis.|||units on a scale||Standard Deviation|Mean
2630113|NCT01856530|Secondary|Perceived Preference Scores on a 1-7 Likert Scale|Participants will rate their level of preference (on a 1-7 Likert scale) for Player 1 during online ball-tossing task. Higher scores on this scale reflect greater preference for Player 1.|Day 1 (first day oxytocin or placebo was administered)|Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in the analysis. Thus, only 52 participants were included in this analysis.|||units on a scale||Standard Deviation|Mean
2630114|NCT01856530|Secondary|Perceived Empathy Scores on a 1-7 Likert Scale|Participants will rate their level of perceived empathy (on a 1-7 Likert scale) with Player 1 during online ball-tossing task. Higher scores on this scale reflect greater perceived empathy toward Player 1.|Day 1 (first day oxytocin or placebo was administered)|Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in the analysis. Thus, only 52 participants were included in this analysis.|||units on a scale||Standard Deviation|Mean
2630115|NCT01856530|Secondary|Perceived Trust Scores on a 1-7 Likert Scale|Participants will rate their perceived level of trust (on a 1-7 Likert scale) toward Player 1 during online ball-tossing task. Higher ratings on this scale reflect greater perceived trust toward Player 1.|Day 1 (first day oxytocin or placebo was administered)|Due to technical difficulties during the computer task, two participants did not complete this questionnaire and were not included in the analysis. Thus, only 52 participants were included in this analysis.|||units on a scale||Standard Deviation|Mean
2630116|NCT01856530|Primary|Disengagement From Social Threat Cues|The outcome measure involved difference scores in response latencies on disengagement trials for disgust versus neutral cues. Difference scores were calculated as response latencies during disengagement trials for disgust cues minus response latencies during disengagement trials for neutral cues. Negative change scores represent an improvement in disengagement.|Day 1 (first day oxytocin or placebo was administered)||||Milliseconds||Standard Deviation|Mean
2630117|NCT01856530|Primary|Social Cooperation|"The outcome measure involved difference scores in the number of balls tossed to Player 1 between two conditions of the task. Across both conditions, the participant (always assigned as Player 2) played with 3 other on-line players in real time. In Condition 1, Player 1 was programmed to toss on average 70% of his balls to the participant. In Condition 2, Player 1's behavior switched such that he was programmed to toss on average only 10% of his balls to the participant. The data reported below is the number of balls tossed to Player 1 in Condition 2 minus balls tossed under Condition 1."|Day 1 (first day oxytocin or placebo was administered)|Data from 2 participants could not be analyzed due to technical difficulties with the computer task. Thus, the number of participants analyzed was 52 in total, rather than 54.|||Ball tosses||Standard Deviation|Mean
2630118|NCT01856491|Other Pre-specified|Pacing Impedance|"Lead performance evaluations of the Reliance 4-FRONT PASSIVE fixation lead have been conducted in accordance with the Physician's Lead Manual. Measurements should fall within the recommended values as mentioned below:~Signal Type Amplitude Pacing Threshold Impedance Pacing/Sensing ≥ 5mV ≤1.5 V 300-1200 Ω Defibrillation ≥ 1mV N/A 20—125 Ω The required data from the implant procedure for the study lead is measured with a pacing system analyzer (PSA) to verify adequate signals. Electrical performance of the lead was verified before attaching the lead to the Pulse Generator (PG). After the PG has been implanted evaluation of the study lead using the PG has been performed. Lead measurements were required unless the testing is prohibited by a subject's condition (subject has no intrinsic rhythm). In case the measurements are variable (e.g. in patients with atrial fibrillation), the most reproducible value has been collected."|3 Months Post-Implant|167 patients have been enrolled. For 150 patients we were able to collect the 3 month pacing impedance|||Ohm||Standard Deviation|Mean
2630119|NCT01856491|Other Pre-specified|Sensed Amplitude|"Lead performance evaluations of the Reliance 4-FRONT PASSIVE fixation lead have been conducted in accordance with the Physician's Lead Manual. Measurements should fall within the recommended values as mentioned below:~Signal Type Amplitude Pacing Threshold Impedance Pacing/Sensing ≥ 5mV ≤1.5 V 300-1200 Ω Defibrillation ≥ 1mV N/A 20—125 Ω The required data from the implant procedure for the study lead is measured with a pacing system analyzer (PSA) to verify adequate signals. Electrical performance of the lead was verified before attaching the lead to the Pulse Generator (PG). After the PG has been implanted evaluation of the study lead using the PG has been performed. Lead measurements were required unless the testing is prohibited by a subject's condition (subject has no intrinsic rhythm). In case the measurements are variable (e.g. in patients with atrial fibrillation), the most reproducible value has been collected."|3 Months Post-Implant|167 patients were enrolled. From 141 patients we could collected the sensed amplitude at 3 months|||mVolt||Standard Deviation|Mean
2630120|NCT01856491|Other Pre-specified|Complication Free Rate|Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant|3 months through 24 months post implant||||percentage of patients without events||95% Confidence Interval|Number
2630121|NCT01856491|Other Pre-specified|Pacing Threshold at 0.5 ms Pulse Width|Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant. During the RELIANCE 4-FRONT PASSIVE fixation PMCF Study pacing threshold measurements are collected from RELIANCE 4-FRONT PASSIVE fixation leads in the standard manual fashion. At least 3 cardiac cycles at a given voltage level shall be obtained before stepping down to the next voltage level. A count of two non-capture beats is required at a given voltage level to declare a loss of capture (LOC) for any of these tests. The threshold is defined as one voltage level above the level where two non-captured beats are observed. Threshold tests must be taken with a pulse width of 0.5 ms.|3 Months Post-Implant|167 have been enrolled. 138 were included in the analysis because we have the lead measurements for those number of patients collected .|||Volt||Standard Deviation|Mean
2630122|NCT01856491|Secondary|Complication Free Rate|Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.|3 months through 15 months post implant|Subjects were eligible for the secondary endpoint analysis if their date of last follow-up was ≥92 days post-implant procedure.|||percentage of patients without events||95% Confidence Interval|Number
2630123|NCT01856491|Primary|Complication Free Rate|Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.|3-months|167 have been enrolled. 165 were included in the analysis because for 2 patients the leads have not been implanted|||percentage of patients without event||95% Confidence Interval|Number
2630124|NCT01856361|Other Pre-specified|Seminal Angiotensin II and Serum Bradykinin Levels||32 weeks|Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.||||||
2630125|NCT01856361|Secondary|Hormonal Profile|LH, FSH, serum testosterone, prolactin|32 weeks|Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.||||||
2630126|NCT01856361|Secondary|Pregnancy Rate||32 weeks|Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.||||||
2630127|NCT01856361|Secondary|Total Motile Sperm Count(TMSC), Total Sperm Count, Sperm Motility, and Morphology in the Ejaculate.|The efficacy of ramipril in improving total sperm count will be evaluated, as well as, improving sperm motility, and morphology.|32 weeks|Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.||||||
2630128|NCT01856361|Primary|Sperm Density in Infertile Men With Documented Oligospermia.||32 weeks|Data was not collected on the 2 participants as the principal investigator on this trial moved to a different practice and thus the study terminated before any results could be analyzed.||||||
2630129|NCT01856322|Primary|Difference in Circulating S100A4 Transcript in Patients Receiving Sulindac 150 mg BD (Twice Daily) by Mouth Following Resection of Colorectal Cancer Metastases Compared to Those Who do Not.|Difference in circulating S100A4 transcript levels will be determined by assessing the circulating S100A4 transcript level at initial presentation versus the circulating S100A4 transcript level post resection.|3 years|The trial was prematurely closed due to lack of accrual, thus the outcome measure was not met.||||||
2630130|NCT01856309|Secondary|Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 260|HAQ-DI response was defined as change of less than -0.22 from baseline in HAQ-DI score. The HAQ-DI score is an evaluation of the functional status for a participant. The 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Participants were analyzed for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260|"Population included all participants who were enrolled in this study. For Placebo to 50mg and Placebo to 100mg groups, only efficacy data collected after escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies the number of participants analyzed at the specified time point."|||Percentage of participants|||Number
2630131|NCT01856309|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 260|The Health Assessment Questionnaire-Disability Index (HAQ-DI) score is an evaluation of the functional status for a participant. The 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty. Participants were analyzed for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received.|Baseline (Week 0 of primary studies), Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260|"Population included all participants who were enrolled in this study. For Placebo to 50mg and Placebo to 100mg groups, only efficacy data collected after the escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies number of participants analyzed at specified time point."|||Units on Scale||Standard Deviation|Mean
2630132|NCT01856309|Secondary|Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 260|Participant having SDAI-based ACR/EULAR remission at a visit if SDAI score is of <= 3.3. SDAI derived by combining 5 disease assessments: tender joint (28), swollen joint (28) counts, participants global assessment of disease activity using VAS (scale ranges from 0 to 10 [0 =very well to 10 = very poor]), physicians global assessment of disease activity using VAS (scale ranges from 0 to 10 [0=no arthritis to 10=extremely active arthritis]) and CRP. 28 joints evaluated for swelling and tenderness are same set of 28 joints used in DAS28 includes shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of upper right and left extremities and knee joints of lower right and left extremities. Participants were analyzed for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260|"Population included all participants who were enrolled in this study. For Placebo to 50mg and Placebo to 100mg groups, only efficacy data collected after escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies the number of participants analyzed at the specified time point."|||Percentage of participants|||Number
2630133|NCT01856309|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 260|The CDAI score is a derived score of 4 components: tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, and physician's global assessments of disease activity. The total score ranges from 0 to 76 with a lower score indicating less disease activity. A negative change in CDAI score indicates an improvement in disease activity and a positive change in score indicates a worsening of disease activity. Participants were analyzed for efficacy according to the assigned treatment groups from the primary studies, regardless of the treatments they actually received.|Baseline (Week 0 of primary studies), Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260|"Population included all participants who were enrolled in this study. For Placebo to 50mg and Placebo to 100mg groups, only efficacy data collected after escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies the number of participants analyzed at specified time point."|||Units on a scale||Standard Deviation|Mean
2630142|NCT01856309|Secondary|Percentage of Participants With AST >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN|Percentage of participants with Aspartate Aminotransferase (AST) >= 3*ULN, AST >= 5*ULN and AST >= 8*ULN was reported.|From baseline of primary studies through end of this LTE study (Approximately 5.3 years)|Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.|||Percentage of participants|||Number
2630134|NCT01856309|Secondary|Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission Through Week 260|The Disease Activity Index Score 28 (DAS28) based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (<) 2.6 at any study visit. Participants were analyzed for efficacy according to the assigned treatment groups from the primary studies, regardless of the treatments they actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260|"Population included all participants who were enrolled in this study. For Placebo to 50mg and Placebo to 100mg groups, only efficacy data collected after escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies the number of participants analyzed at the specified time point."|||Percentage of participants|||Number
2630135|NCT01856309|Secondary|Percentage of Participants With Boolean-Based American College of Rheumatology (ACR) or European League Against Rheumatism (EULAR) Remission Through Week 260|Boolean based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) <=1; swollen joint count (66 joints) <=1; CRP <=1 milligram per deciliter (mg/dL); and patient's global assessment of disease activity on visual analog scale (VAS) <=1 on a 0 (very well ) to 10 (extremely bad) scale. Higher scores indicates worst health condition. Participants were analyzed for efficacy according to the assigned treatment groups from the primary studies, regardless of the treatments they actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260|"Population included all participants who were enrolled in this study. For Placebo to 50mg and Placebo to 100mg groups, only efficacy data collected after escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies the number of participants analyzed at the specified time point."|||Percentage of participants|||Number
2630136|NCT01856309|Secondary|Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response Through Week 260|ACR 50 response is greater than or equal to (>=) 50 percent (%) improvement in both tender joint count (68) and swollen joint count (66) and >= 50% improvement in 3 of following 5 assessments:Participant's assessment of pain using visual analog scale (VAS) (0-10 scale, 0=no pain and 10=worst possible pain),Participant's global assessment of disease activity by using VAS (scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician's global assessment of disease activity using VAS (scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) (scale ranges from 0= no difficulty to 3= inability to perform a task in that area), and Serum C-reactive protein (CRP). Participants were analyzed for efficacy according to assigned treatment groups from the primary studies, regardless of treatments actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52, 76, 80, 104, 128, 132, 156, 180, 208, 232 and 260|"Population included all participants who were enrolled in this study. For Placebo to 50mg and Placebo to 100mg groups, only efficacy data collected after escape or CO (after Week 18) to sirukumab was planned to be reported, with exception of baseline data. Here 'n' signifies the number of participants analyzed at the specified time point."|||Percentage of participants|||Number
2630137|NCT01856309|Secondary|Percentage of Participants With Normal Triglyceride Value at Baseline and at Least 1 Abnormal Value Post-Baseline|Percentage of participants with normal triglyceride value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal triglyceride value was defined as triglyceride value > 250 mg/dL.|From baseline of primary studies through end of this LTE study (Approximately 5.3 years)|Population included all participants who were enrolled in this study and had triglyceride baseline value within normal range.|||Percentage of participants|||Number
2630138|NCT01856309|Secondary|Percentage of Participants With Normal High-Density Lipoprotein (HDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline|Percentage of participants with normal HDL value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal HDL value was defined as HDL value < 40 mg/dL.|From baseline of primary studies through end of this LTE study (Approximately 5.3 years)|Population included all participants who were enrolled in this study and had HDL baseline value within normal range.|||Percentage of participants|||Number
2630139|NCT01856309|Secondary|Percentage of Participants With Normal Low-Density Lipoprotein (LDL) Value at Baseline and at Least 1 Abnormal Value Post-Baseline|Percentage of participants with normal LDL value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal LDL value was defined as LDL value > 130 mg/dL.|From baseline of primary studies through end of this LTE study (Approximately 5.3 years)|Population included all participants who were enrolled in this study and had LDL baseline value within normal range.|||Percentage of participants|||Number
2630140|NCT01856309|Secondary|Percentage of Participants With Normal Total Cholesterol Value at Baseline and at Least 1 Abnormal Value Post-Baseline|Percentage of participants with normal total cholesterol value at baseline and at least 1 abnormal value post-baseline was reported. Abnormal total cholesterol value was defined as total cholesterol value more than (>) 200 milligrams per deciliter (mg/dL).|From baseline of primary studies through end of this LTE study (Approximately 5.3 years)|Population included all participants who were enrolled in this study and had total cholesterol baseline value within normal range.|||Percentage of participants|||Number
2630141|NCT01856309|Secondary|Percentage of Participants With Either ALT >= 3*ULN or AST >= 3*ULN, and Total Bilirubin >= 2*ULN|Percentage of participants with either ALT >= 3*ULN or AST >= 3*ULN and total bilirubin >= 2*ULN was reported.|From baseline of primary studies through end of this LTE study (Approximately 5.3 years)|Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.|||Percentage of participants|||Number
2630155|NCT01856270|Secondary|Trail Making Test (A)|Trail Making Test will be given at 30 days to detect any impact of study drug on cognition. This is a test of visual attention and is scored by the number of seconds it takes to complete the task of making a trail through letters.|30 days||||seconds||Standard Deviation|Mean
2630143|NCT01856309|Secondary|Percentage of Participants With ALT >= 3*ULN, ALT >= 5*ULN and ALT >= 8*ULN|Percentage of participants with Alanine Aminotranserase (ALT) >= 3*Upper Limit of Normal (ULN), ALT >= 5*ULN or ALT >= 8*ULN was reported.|From baseline of primary studies through end of this LTE study (Approximately 5.3 years)|Population included all participants who were enrolled in this study. 1 participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.|||Percentage of participants|||Number
2630144|NCT01856309|Secondary|Percentage of Participants With Toxicity Grade 4 Decrease in Platelets|Percentage of participants with toxicity grade 4 decrease in platelets was reported. As per National Cancer Institute's Common Terminology Criteria for Adverse Events, toxicity grade 4 was defined as decreased in platelets <25000/mm^3 or < 25.0 * 10^9 per liter.|From baseline of primary studies through end of this LTE study (Approximately 5.3 years)|Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.|||Percentage of participants|||Number
2630145|NCT01856309|Secondary|Percentage of Participants With Toxicity Grade 4 Decrease in Neutrophils|Percentage of participants with toxicity grade 4 decrease in neutrophils was reported. As per National Cancer Institute's Common Terminology Criteria for Adverse Events, toxicity grade 4 was defined as decrease in neutrophils less than (<) 500 per Cubic Millimeter (mm^3) or < 0.5 * 10^9 per liter.|From baseline of primary studies through end of this LTE study (Approximately 5.3 years)|Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.|||Percentage of participants|||Number
2630146|NCT01856309|Primary|Percentage of Participants With Serious or Moderate/Severe Systemic Hypersensitivity Reactions, or Serum Sickness Adverse Events|Percentage of participants with serious or moderate/severe systemic hypersensitivity reactions, or serum sickness adverse events (AEs) was reported.|From baseline of this LTE study up to 4.3 years|Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.|||Percentage of participants|||Number
2630147|NCT01856309|Primary|Percentage of Participants With Hepatobiliary Abnormalities|Percentage of participants with hepatobiliary abnormalities was reported.|From baseline of this LTE study up to 4.3 years|Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.|||Percentage of participants|||Number
2630148|NCT01856309|Primary|Percentage of Participants With Gastrointestinal (GI) Perforations|Percentage of participants with one or more GI perforations was reported. GI perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder.|From baseline of this LTE study up to 4.3 years|Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.|||Percentage of participants|||Number
2630149|NCT01856309|Primary|Percentage of Participants With Serious Infections|Percentage of participants with one or more serious infections was reported.|From baseline of this LTE study up to 4.3 years|Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.|||Percentage of participants|||Number
2630150|NCT01856309|Primary|Percentage of Participants With Malignancies|Percentage of participants with one or more malignancy was reported.|From baseline of this LTE study up to 4.3 years|Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.|||Percentage of participants|||Number
2630151|NCT01856309|Primary|Percentage of Participants With Major Adverse Cardiovascular Events (MACE)|MACE was defined as a composite of Myocardial Infarction (MI), stroke, death, hospitalization for unstable angina, and hospitalization for Transient Ischemic Attack (TIA). Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion.|From baseline of this LTE study up to 4.3 years|Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.|||Percentage of participants|||Number
2630152|NCT01856309|Primary|Percentage of Participants With Serious Adverse Events (SAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|From baseline of this LTE study up to 4.3 years|Population included all participants who were enrolled in this study. One participant who mistakenly took sirukumab 100mg, when was originally assigned to sirukumab 50mg, was analyzed under the sirukumab 100mg group for all safety analyses.|||Percentage of participants|||Number
2630153|NCT01856270|Secondary|Wechsler Adult Intelligence Scale (WAIS) IV Digit Symbol|The WAIS IV Digit Symbol test will be given to detect any effect of study drug on cognition. This test assesses processing speed and new learning and requires an individual to substitute the relevant digit for a symbol and are given a time limit. The total number of correct digits are summed and converted to a scaled score (range 1-20 with 10 being at the 50th percentile) with higher scores indicating better performance.|30 days||||standard score||Standard Deviation|Mean
2630154|NCT01856270|Secondary|Trail Making Test (B)|Trail Making Test will be given at 30 days to detect any impact of study drug on cognition. This is a test of visual attention and task switching and is scored by number of seconds it takes to complete the task (switching from letters to numbers in order).|30 days||||seconds||Standard Deviation|Mean
2630400|NCT01854593|Secondary|Surgical Time||End of surgery.||||minutes||Standard Deviation|Mean
2630401|NCT01854593|Secondary|Iatrogenic Retinal Tears|The number of participants who had intraoperative iatrogenic retinal tears.|End of surgery.||||participants|||Number
2630156|NCT01856270|Secondary|Rey Auditory Verbal Learning Test (Long)|The Rey Auditory Verbal Learning Test will be administered at 30 days to detect potential changes in cognitive function due to study drug. Scoring is based on the total number of words recalled from the original list of 15 after a 30 minute time delay. Higher scores indicate better long-term memory.|30 days||||words recalled||Standard Deviation|Mean
2630157|NCT01856270|Secondary|Rey Auditory Verbal Learning Test (Short)|The Rey Auditory Verbal Learning Test will be administered at 30 days to detect potential changes in cognitive function due to study drug. Scoring is based on the total number of words recalled from the original list of 15 after a new list of 15 is given (used as distraction). Higher scores indicate better short-term memory.|30 days||||words recalled||Standard Deviation|Mean
2630158|NCT01856270|Secondary|Rey Auditory Verbal Learning Test (Total)|The Rey Auditory Verbal Learning Test will be administered at 30 days to detect potential changes in cognitive function due to study drug. Scoring is based on the total number of words recalled from a list of 15 across 5 trials (max score of 75) with higher score indicating better learning.|30 days||||words recalled||Standard Deviation|Mean
2630159|NCT01856270|Secondary|Number of Participants With Adverse Events Possibly Related to Study Medication|The number and types of treatment related adverse events will be monitored on a weekly basis and will be divided by severity if differing.|Day 1 through Day 90||||Participants|||Count of Participants
2630160|NCT01856270|Primary|Severity of Headache|Number of subjects with headache reporting an average pain of at least 6 on a 0-10 scale with 0=no pain and 10=worst pain.|90 days|The two arms are combined for this analysis to answer the question of severity of headache at the 3 month outcome data point and only difference between arms was related to onset time of medication which was not expected to result in significant change in headache frequency, but only potentially in cognitive status.|||Participants|||Count of Participants
2630161|NCT01856270|Primary|Frequency of Headaches|Number of subjects reporting an average of at least one headache per week|90 days|The two arms are combined for this analysis to answer the question of frequency of headache at the 3 month outcome data point and only difference between arms was related to onset time of medication which was not expected to result in significant change in headache frequency, but only potentially in cognitive status.|||Participants|||Count of Participants
2630162|NCT01856257|Secondary|Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90 mmHg Within 24 Hours of Onset of Transplant Procedure|Temperature of >39 degrees Celsius (e.g., 102.2 degrees Fahrenheit) would be an indication of fever most often in response to an infection or illness. Systolic blood pressure <90mm Hg would be an indication of low blood pressure.|Within 24 Hours of transplant procedure|Intent-to-treat population|||Participants|||Count of Participants
2630163|NCT01856257|Secondary|Count of Participants With Epstein-Barr Virus (EBV) Infection as Reported on the Case Report Form as Adverse Events|Viral infections following renal transplantation, including but not limited to EBV infection, is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
2630164|NCT01856257|Secondary|Count of Participants With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia (Local Center Monitoring) as Adverse Events by Wk 52 Post-Transplant|Viral infections following renal transplantation is significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during the study, using participant blood samples. Displayed are counts of participants who experienced BKV and CMV viremia as adverse events by treatment arm.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
2630165|NCT01856257|Secondary|Count of Participants With Infections Requiring Hospitalization or Systemic Therapy by Wk 52 Post-Transplant|Infections of certain types (i.e., excluding those identified in the protocol as occurring commonly in this study population) were required to be reported as a serious adverse event if they required either inpatient hospitalization or prolongation of a current hospitalization.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
2630166|NCT01856257|Secondary|Count of Participants Experiencing ≥ 1 Adverse Event (AEs) or Serious Adverse Events (SAEs) by Wk 52|Adverse events were collected systematically from enrollment through Wk 52, the last study visit. Provided are numbers of participants with ≥ 1 adverse event (serious or non-serious adverse events) by treatment arm.|Enrollment through Week 52|Intent-to-treat population|||Participants|||Count of Participants
2630167|NCT01856257|Secondary|Count of Participants With Graft Rejection by Wk 52 Post-Transplant|The number of participants who were treated by their local physician for any type of rejection including, but not limited to cellular rejection and antibody- mediated rejection of the transplanted kidney regardless of the presence of a biopsy.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
2630168|NCT01856257|Secondary|Count of Participant Deaths or Graft Loss by Wk 52 Post-Transplant|This measure counts deaths and graft loss occurring at any point post transplantation. Graft loss is defined as 90 days of dialysis dependency.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
2630169|NCT01856257|Secondary|Total Daily Prescribed Pill Count|This is a measure of the total number of pills a participant was prescribed on a given day|Day 28, Day 84, Week 28, Week 36, and Week 52|Intent-to-treat population with available data|||pills per day||Standard Deviation|Mean
2630170|NCT01856257|Secondary|Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant|Lipid lowering medications are used in the treatment of high levels of fats (lipids), such as cholesterol in blood.|Baseline (Pre-Transplant), Week 28, and Week 52|Intent-to-treat population with available data|||Participants|||Count of Participants
2630181|NCT01856257|Secondary|Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies|"Upon having a biopsy performed, persons often receive treatment for rejection based on the results of the biopsy, which may or may not have shown signs of rejection. Details of local biopsy findings are presented here for rejection. Acronyms and abbreviations are defined as follows:~ACR= Acute T-Cell Mediated rejection~AMR= Acute Antibody-mediated rejection~Chr. AMR=Chronic Antibody Mediated Rejection~Gd.=Grade~IFTA=Interstitial Fibrosis and Tubular Atrophy"|Transplantation through Week 52|Intent-to-treat population|||Biopsy|||Number
2630402|NCT01854593|Secondary|Endolaser Photocoagulation|Number of intraoperative endolaser photocoagulation.|End of surgery.||||photocoagulation||Standard Deviation|Mean
2630171|NCT01856257|Secondary|Fasting Lipid Profile at Wk 52 Post-Transplant|"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:~Total cholesterol: 75-169 mg/dL if age ≤ 20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease."|Week 52|Intent-to-treat population with available data|||mg/dL||Standard Deviation|Mean
2630172|NCT01856257|Secondary|Fasting Lipid Profile at Wk 28 Post-Transplant|"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:~Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease."|Week 28|Intent-to-treat population with available data|||mg/dL||Standard Deviation|Mean
2630173|NCT01856257|Secondary|Fasting Lipid Profile at Baseline (Pre-Transplant)|"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:~Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease."|Baseline|Intent-to-treat population with available data|||mg/dL||Standard Deviation|Mean
2630174|NCT01856257|Secondary|Count of Participants With Use of Anti-hypertensive Medication at Wk 52 Post-Transplant|Anti-hypertensive medications are a class of drugs that are used to treat hypertension. The medications seek to prevent the complications of high blood pressure, such as stroke and myocardial infarction.|Week 52|Intent-to-treat population with available data|||Participants|||Count of Participants
2630175|NCT01856257|Secondary|Standardized Blood Pressure Measurement at Wk 52 Post-Transplant|"A blood pressure measurement consists of two numbers: the systolic and diastolic pressures. Systolic pressure measures the pressure in blood vessels when the heart beats. Diastolic pressure measures the pressure in blood vessels between beats of the heart.~Systolic measures of <120 and diastolic measures of <80 are considered normal.~Systolic measures of 120-139 and diastolic measures of 80-89 are considered at risk (or pre-hypertension).~Systolic measures of ≥140 and diastolic measures of ≥90 are considered high."|Week 52|Intent-to-treat population with available data|||mmHg||Standard Deviation|Mean
2630176|NCT01856257|Secondary|Hemoglobin A1c (HbA1c) Measurements Over Time|"Hemoglobin A1c (HbA1c) measures the average blood glucose levels over 8-12 weeks, thus acting as a useful long-term gauge of blood glucose control:~A value below 6.0% reflects normal levels,~6.0% to 6.4% reflects prediabetes, and~a value of ≥ 6.5% reflects diabetes."|Baseline (Pre-Transplant) and Days 28 and -84, and Weeks 28, -36, and -52 Post-Transplant|Intent-to-treat population with available data|||percentage||Standard Deviation|Mean
2630177|NCT01856257|Secondary|Count of Participants With Treated Diabetes Between Day 14 and Wk 52 Post-Transplant|Treated diabetes is defined as receipt of any oral medication or insulin for the treatment of diabetes for >14 days.|Day 14 through week 52|Intent-to-treat population with available data|||Participants|||Count of Participants
2630178|NCT01856257|Secondary|Count of Participants With Either New Onset Diabetes After Transplant (NODAT) or Impaired Fasting Glucose (IFG) at Week 52 Post-Transplant -Based on Criteria Specified by the ADA and WHO|"New onset diabetes is the development of diabetes post-kidney transplant. It was identified by the clinical sites caring for each participant and reported directly in the clinical database. Impaired fasting glucose (IFG) is a determination made by referencing glucose measurements obtained from a standard chemistry panel. Any fasting glucose measure that is between 110 and 125 mg/dL is classified as IFG.~Acronyms: American Diabetes Association (ADA); World Health Organization (WHO)."|Transplantation through Week 52|Intent-to-treat population with available data|||Participants|||Count of Participants
2630179|NCT01856257|Secondary|Count of Participants With De Novo Anti-Donor Histocompatibility Antigen (HLA) Antibodies at Wk 52 Post-Transplant|"The presence of antibodies reactive to Histocompatibility Antigen (HLA) molecules expressed on the renal allograft have been associated with both acute and chronic injury to the transplanted kidney. The development of de novo anti donor HLA antibodies may mean a person is more likely to reject the graft.~No data available."|Week 52|No analysis due to no available data. Data were not reported from the central laboratory and, therefore, unable to be summarized.||||||
2630180|NCT01856257|Secondary|Type of Treatment for Detected Graft Rejection|"Upon having a biopsy performed, persons often receive treatment for rejection based on the results of the biopsy, which may or may not have shown signs of rejection. Details of treatment are presented here for rejection. Acronyms and abbreviations are defined below.~ATG=Thymoglobulin"|Transplantation through Week 52|Intent-to-treat population|||Biopsy|||Number
2630182|NCT01856257|Secondary|Count of Participants With Antibody Mediated Rejection by Wk 52 Post-Transplant|Antibody mediated rejection is defined by diffusely positive staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury and was determined by local pathology.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
2630183|NCT01856257|Secondary|Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant|Acute cellular rejection occurs when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade equal to or greater than IA by Banff 2007 criteria as determined by local pathology. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection. Originally it was 2 endpoints but all participants' highest grade was also their first grade so only reporting their first grade.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
2630184|NCT01856257|Secondary|Count of Participants With Acute Cellular Rejection Grade ≥ IA Defined by Banff 2007 Criteria By Wk 52 Post-Transplant|Acute cellular rejection occurs when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade equal to or greater than IA by Banff 2007 criteria as determined by local pathology.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
2630185|NCT01856257|Secondary|Count of Participants With Delayed Graft Function at Wk 52 Post-Transplant|Delayed grafted function is defined as dialysis in the first week on one or more occasions for any indication other than the treatment of acute hyperkalemia in the setting of otherwise acceptable renal function.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
2630186|NCT01856257|Secondary|The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Post-Transplant|"The estimated Glomerular Filtration Rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):~A score of ≥ 90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate very severe or endstage kidney failure.~An estimate of the slope, or change over time, in eGFR was produced using standard statistical linear modeling procedures. The estimate was then re-scaled so that it could be interpreted as a change in eGFR per month. Positive numbers indicate increasing kidney function.~Larger numbers indicate greater change in kidney function."|Day 28 through Week 52 Post-Transplant|Intent-to-treat population with available data|||eGFR change over time (by month)||Standard Deviation|Mean
2630187|NCT01856257|Secondary|Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant|"The estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease equation (MDRD):~A score of ≥ 90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate severe or endstage kidney failure."|Week 52|Intent-to-treat population with available data|||mL/min/1.73m^2||Standard Deviation|Mean
2630188|NCT01856257|Secondary|Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant|"The stages of Chronic Kidney Disease (CKD) are defined using the participant's GFR value:~Stage 1 if GFR value is ≥ 90 (kidney function is normal)~Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease)~Stage 3A if 45 <= GFR < 60*~Stage 3B if 30 <= GFR < 45*~Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function)~Stage 5 if GFR < 15 (severe or end stage kidney failure).~Stages 3A abd 3B indicate moderately reduced kidney function.*"|Week 52|Intent-to-treat population|||Participants|||Count of Participants
2630189|NCT01856257|Secondary|Count of Participants by CKD Stage at Wk 52|"The stages of Chronic Kidney Disease are defined using the participant's GFR value:~Stage 1 if GFR value is ≥90 ( kidney function is normal)~Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease)~Stage 3A if 45 ≤ GFR < 60*~Stage 3B if 30 ≤ GFR < 45*~Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function)~Stage 5 if GFR < 15 (severe or end stage kidney failure).~Stages 3A and 3B indicate moderately reduced kidney function.*"|Week 52|Intent-to-treat population|||Participants|||Count of Participants
2630190|NCT01856257|Secondary|Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant|"eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):~A score of ≥90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate very severe or end stage kidney failure."|Week 52|Intent-to-treat population|||Participants|||Count of Participants
2630191|NCT01856257|Secondary|Count of Participants With Biopsy Proven Acute Rejection By Wk 52 Post-Transplant|Biopsy proven acute rejection definition: histologic evidence of a Banff grade of ≥1A per local pathologist.|Transplantation through Week 52|Intent-to-treat population|||Participants|||Count of Participants
2630192|NCT01856257|Primary|Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant|"eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):~A score of ≥90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate very severe or end stage kidney failure."|Week 52|Intent-to-treat population with available data at week 52|||mL/min/1.73m^2||Standard Deviation|Mean
2630193|NCT01856218|Secondary|Change From Baseline at Week 36 in Shoulder Range of Motion (Goniometry)|The maximum passive shoulder range of motion in both flexion and extension will be measured in degrees using a goniometer.|Baseline, Week 36|Summary analyses for all 3 participants are not available due to the very small number of participants; and while data were collected for 1 participant, they are not being reported due to confidentiality issues.||||||
2630357|NCT01854710|Other Pre-specified|Maximum Effect of Moxifloxacin on Cardiac Repolarization (QTc Interval Duration) Compared to Placebo (Study Assay Sensitivity)|A thorough QT/QTc study may be considered to have demonstrated assay sensitivity if 1 or more of the lower 95% CI values exceeds 5 msec|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- LSM and CI statistics were based on the individual (within subject) corrected differences between moxifloxacin and placebo exposures per ICH Guideline E14 for a thorough QT study.|||msec||95% Confidence Interval|Least Squares Mean
2630194|NCT01856218|Secondary|Change From Baseline at Week 36 in Growth Velocity for Height and Weight|Growth velocity (for males ≤18 years and females ≤15) was calculated from anthropometric measurements and compared with pretreatment growth velocity when available. Z-scores and percentiles were calculated using Centers for Disease Control (CDC) growth chart.|Baseline, Week 36|Summary analyses for all 3 participants combined are not available. Due to the very small number of participants, formal statistical analyses were not performed; and data were presented per participant, which has the potential for participant re-identification given the rarity of disease and the very small population size.||||||
2630195|NCT01856218|Secondary|Change From Baseline at Week 36 in Pulmonary Function Testing (Spirometry)|The following spirometry tests were administered to participants who did not require invasive ventilatory support or have a tracheostomy in accordance with American Thoracic Society/European Respiratory society (ATS/ERS) guidelines: forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), maximum voluntary ventilation in one minute (MVV1). Invasive ventilation is defined as any form of ventilatory support applied with the use of an endotracheal tube.|Baseline, Week 36|Summary analyses for all 3 participants are not available due to the very small number of participants; and while data were collected for 1 participant, they are not being reported due to confidentiality issues.||||||
2630196|NCT01856218|Secondary|Change From Baseline at Week 36 in the 3-Minute Stair Climb Test (3MSCT)|The number of stairs climbed within a 3-minute period was assessed once each test day using available hospital stairs. Participants who could not climb stairs could omit this test.|Baseline, Week 36|Summary analyses for all 3 participants are not available due to the very small number of participants; and while data were collected for 1 participant, they are not being reported due to confidentiality issues.||||||
2630197|NCT01856218|Secondary|Percent of Predicted Normal Distance Walked|The percent of predicted normal distance walked (based on published normative data) in the total distance walked in a six-minute period.|36 Weeks|Summary analyses for all 3 participants are not available due to the very small number of participants; and while data were collected for 1 participant, they are not being reported due to confidentiality issues.||||||
2630198|NCT01856218|Secondary|Change From Baseline at Week 36 in Six-Minute Walk Test (6MWT)|The total distance walked (meters) in a 6-minute period was measured once each test day. The test was conducted using a pre-measured walking course according to administration guidelines established by the American Thoracic Society (ATS 2002). Participants who could not walk could omit this test.|Baseline, Week 36|Summary analyses for all 3 participants are not available due to the very small number of participants; and while data were collected for 1 participant, they are not being reported due to confidentiality issues.||||||
2630199|NCT01856218|Secondary|Acceptable Dose as Determined by Total uGAG Excretion Using a Forced Dose Titration Regimen|The choice of the dose of UX003 QOW for the Long-Term Extension Phase was based on a preliminary efficacy analysis at Week 36 prior to all 3 participants completing the Forced-dose Titration Period of the First Phase of the study.|Week 36||||mg/kg|||Number
2630200|NCT01856218|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Study/Treatment Discontinuations|Adverse Event (AE): any untoward medical occurrence in a subject, whether or not considered drug related. SAE: an AE or suspected adverse reaction that at any dose results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect. Other important medical events may also, in the opinion of the Investigator, be considered SAEs. An AE was considered a TEAE if it occurred on or after the first dose, and was not present prior to the first dose, or it was present at the first dose but increased in severity during the study. Events recorded as either possibly, probably, or definitely related to treatment were categorized as related. AE severity was graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events, Version 4.03.|Up to 242 weeks + 30 days. SAEs were recorded beginning at the time the subject signed the informed consent form through 30 days following the last study visit. Non-serious AEs were recorded from the time of informed consent through the last study visit.||||participants|||Number
2630201|NCT01856218|Primary|Number of Participants With Any ≥ 50% Decrease in uGAG|Participants with a ≥ 50% decrease in the concentration of uGAGs normalized to the urinary creatinine concentration as measured by liquid chromatography-mass spectrometry/mass spectrometry-dermatan sulfate or chondroitin sulfate.|up to Week 132||||Participants|||Count of Participants
2630202|NCT01856218|Primary|Percentage Change From Baseline in uGAG Chondroitin Sulfate|Percentage change from baseline in the concentration of uGAGs normalized to the urinary creatinine concentration as measured by liquid chromatography-mass spectrometry/mass spectrometry-chondroitin sulfate.|Baseline, Week 14, Week 22, Week 30, Week 38, Week 72, and end of study (up to Week 132)||||percentage change||Standard Deviation|Mean
2630203|NCT01856218|Primary|Percentage Change From Baseline in Urinary Glycosaminoglycan (uGAG) Dermatan Sulfate|Percentage change from baseline in the concentration of uGAGs normalized to the urinary creatinine concentration as measured by liquid chromatography-mass spectrometry/mass spectrometry-dermatan sulfate.|Baseline, Week 14, Week 22, Week 30, Week 38, Week 72, and end of study (up to Week 132)||||percentage change||Standard Deviation|Mean
2630204|NCT01855997|Other Pre-specified|Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|Non-CN Population; the analysis only included a subset of participants who provided evaluable data.|||participants|||Number
2630205|NCT01855997|Other Pre-specified|Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|CN Population.|||participants|||Number
2630206|NCT01855997|Other Pre-specified|Number of Participants With HBsAg Clearance ≥24 Weeks Post-Treatment|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|GT Population; the analysis only included a subset of participants who provided evaluable data.|||participants|||Number
2630207|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.|||participants|||Number
2630208|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|CN Population.|||participants|||Number
2630209|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|GT Population.|||participants|||Number
2630210|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.|||participants|||Number
2630211|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.|Single blood sample ≥24 weeks post-treatment|CN Population; the analysis only included a subset of participants who provided evaluable data.|||participants|||Number
2630212|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL.|Single blood sample ≥24 weeks post-treatment|GT Population.|||participants|||Number
2630213|NCT01855997|Other Pre-specified|Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Non-CN Population.|||participants|||Number
2630214|NCT01855997|Other Pre-specified|Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative CN Population.|||participants|||Number
2630215|NCT01855997|Other Pre-specified|Number of Participants With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Population.|||participants|||Number
2630216|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Non-CN Population.|||participants|||Number
2630217|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.|||participants|||Number
2630403|NCT01854593|Secondary|Vascular Endothelial Growth Factor Concentration in Vitreous|Vascular endothelial growth factor concentration in vitreous at the start of vitrectomy.|Start of surgery.||||μg/ml||Standard Deviation|Mean
2630218|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined endpoint in this outcome measure.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.|||participants|||Number
2630219|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Non-CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Non-CN Population: All HBeAg-positive participants whose genetic data passed a protocol-specified quality check and did not share common East Asian genetic background as compared to HapMap version 3.0 reference individuals.|||participants|||Number
2630220|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.|||participants|||Number
2630221|NCT01855997|Other Pre-specified|Number of Participants With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population|Single blood samples were used to analyze HBV serology and genotype data at least 24 weeks post-treatment. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.|||participants|||Number
2630222|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs6592052) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|GT Population; the analysis only included a subset of participants who provided evaluable data.|||beta coefficient|||Number
2630223|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|GT Population; the analysis only included a subset of participants who provided evaluable data.|||beta coefficient|||Number
2630224|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs7549785) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|CN Population.|||beta coefficient|||Number
2630225|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs7549785) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|CN Population.|||beta coefficient|||Number
2630226|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs12992677) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|Non-CN Population; the analysis only included a subset of participants who provided evaluable data.|||beta coefficient|||Number
2630256|NCT01855958|Secondary|Intracortical Facilitation (ICF) After Intervention.|"ICF was evaluated using an inter-stimuli intervals (ISIs) of 12 ms with paired-pulse and similar parameters for the conditioning and test stimuli. After a randomized protocol, thirty stimuli were assessed using a 2ms interval (ICI), a 12ms interval (ICF) and test-only trials (MEP). The resulting MEP amplitude was converted into the mean amplitude, and paired-pulse parameters were expressed as the amount of inhibition or facilitation. The calculation result of ICF was done by the ratio of the mean ICF by the mean MEP.~# Below the data after intervention."|Before and within one hour after intervention.||||ratio of amplitude (mV).||Standard Deviation|Mean
2630227|NCT01855997|Primary|SNPs Associated With HBsAg Clearance ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs12992677) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|Non-CN Population; the analysis only included a subset of participants who provided evaluable data.|||beta coefficient|||Number
2630228|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|GT Population.|||beta coefficient|||Number
2630229|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|GT Population.|||beta coefficient|||Number
2630230|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|CN Population; the analysis only included a subset of participants who provided evaluable data.|||beta coefficient|||Number
2630231|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|CN Population; the analysis only included a subset of participants who provided evaluable data.|||beta coefficient|||Number
2630232|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.|||beta coefficient|||Number
2630233|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.|||beta coefficient|||Number
2630234|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|GT Population.|||beta coefficient|||Number
2630235|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|Genetic Data Quality Check (GT) Population: All participants, regardless of HBeAg status, whose genetic data passed a protocol-specified quality check.|||beta coefficient|||Number
2630236|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|CN Population; the analysis only included a subset of participants who provided evaluable data.|||beta coefficient|||Number
2630237|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|CN Population: All participants, regardless of HBeAg status, whose genetic data passed a protocol-specified quality check and shared common East Asian genetic background as compared to HapMap version 3.0 reference individuals; the analysis only included a subset of participants who provided evaluable data.|||beta coefficient|||Number
2630238|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|Non-CN Population.|||beta coefficient|||Number
2630239|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA ≥24 Weeks Post-Treatment in Non-CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|Non-CN Population: All participants, regardless of HBeAg status, whose genetic data passed a protocol-specified quality check and did not share common East Asian genetic background as compared to HapMap version 3.0 reference individuals.|||beta coefficient|||Number
2630240|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Population.|||beta coefficient|||Number
2630404|NCT01854593|Primary|Reoperation|Vitreoretinal reoperation due to recurrent vitreous hemorrhage.|1 month||||participants|||Number
2630241|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Population: All HBeAg-negative participants whose genetic data passed a protocol-specified quality check.|||beta coefficient|||Number
2630242|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative CN Population.|||beta coefficient|||Number
2630243|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative CN Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs2464266) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative CN Population: All HBeAg-negative participants whose genetic data passed a protocol-specified quality check and shared common East Asian genetic background as compared to HapMap version 3.0 reference individuals.|||beta coefficient|||Number
2630244|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Non-CN Population.|||beta coefficient|||Number
2630245|NCT01855997|Primary|SNPs Associated With Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Negative Non-East Asian (Non-CN) Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.|Single blood sample ≥24 weeks post-treatment|HBeAg-Negative Non-CN Population: All HBeAg-negative participants whose genetic data passed a protocol-specified quality check and did not share common East Asian genetic background as compared to HapMap version 3.0 reference individuals.|||beta coefficient|||Number
2630246|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.|||beta coefficient|||Number
2630247|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.|||beta coefficient|||Number
2630405|NCT01854593|Secondary|Postoperative Vitreous Hemorrhage.|Postoperative vitreous hemorrhage that is permitted within 4 weeks after surgery.|1 month||||participants|||Number
2654581|NCT01634269|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||6 months||||mmHg||Standard Deviation|Mean
2630248|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.|||beta coefficient|||Number
2630249|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Model|GWAS approach was used to evaluate association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as HBV DNA level below the lower limit of detection (LLD) of 2000 international units per milliliter (IU/mL). HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.|||beta coefficient|||Number
2630250|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population.|||beta coefficient|||Number
2630251|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive Population: All HBeAg-positive participants whose genetic data passed a protocol-specified quality check.|||beta coefficient|||Number
2630252|NCT01855997|Primary|SNPs Associated With HBeAg Seroconversion or HBsAg Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model|GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population.|||beta coefficient|||Number
2630253|NCT01855997|Primary|Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance ≥24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model|Genome-wide association study (GWAS) approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of the antibody to HBeAg (anti-HBe). HBsAg clearance was defined as the loss of HBsAg, with or without detection of the antibody to HBsAg (anti-HBs). Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p<10^-5 and p<5x10^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.|Single blood sample ≥24 weeks post-treatment|HBeAg-Positive CN Population: All HBeAg-positive participants whose genetic data passed a protocol-specified quality check and shared common East Asian genetic background as compared to haplotype map (HapMap) version 3.0 reference individuals.|||beta coefficient|||Number
2630254|NCT01855958|Primary|Conditioned Pain Modulation (CPM) After Intervention.|"PPT during cold water immersion (PPT+CPM): By measuring PPT during cold water immersion, we evaluated the degree to which pain perception is modulated by conditioned pain modulation (CPM) following the presentation of an initial heterotopic noxious stimulus. Subjects immersed their left hands into cold water (zero to 1°C) for 1 minute. During the last 30 seconds of cold-water immersion, the PPT procedure was administered at the right forearm. The temperature was held constant across during the experiment for each subject.~# Below the data after intervention."|Before and within one hour after intervention.||||Kgf / cm2||Standard Deviation|Mean
2630255|NCT01855958|Secondary|Cortical Silent Period (CSP) After Intervention.|"To determine the cortical silent period (CSP), subjects were instructed to squeeze the dynamometer using their fingers at 20% of maximal force when a single pulse stimulus (130% rMT) was applied. The result was the average of five consecutive measurements. The CSP was determined by the interval between the stimulus and the motor response elicited in the subject.~# Below the data after intervention."|Evaluated before and within one hour after intervention.||||ms (milliseconds).||Standard Deviation|Mean
2630257|NCT01855958|Primary|Motor Evoked Potential (MEP) After Intervention.|"Cortical excitability was assessed using a MagPro X100 (MagVenture Company, Lucernemarken, Denmark) and a figure-of-8 coil centered over the left motor cortex (M1). Subjects were seated in a comfortable reclining chair with their arms and hands lying relaxed on the armrests. The investigators measured the resting motor threshold (rMT) of the right first dorsal interosseous (FDI) muscle. The MEPs were recorded by surface electromyography (EMG) using Ag-AgCl cup electrodes in a belly tendon montage. Resting motor threshold (rMT) was deﬁned as the stimulus intensity at which peak-to-peak MEP amplitude of 50 µV (microvolts) was obtained in at least 5 of 10 consecutive trials.~MEP was deﬁned as approximately 130% of the rMT or the stimulus intensity at which peak-to-peak MEP amplitude of at least 1 mV was obtained in 10 consecutive trials. The result of the MEP was the average of 10 curves (unconditioned MEP).~# Below the data after intervention."|Before and within one hour after intervention.||||mV (millivolts).||Standard Deviation|Mean
2630258|NCT01855958|Primary|Pain Pressure Threshold (PPT) After Intervention..|"PPT (alone): The patient was instructed to verbally report the perception of pain onset. The investigator assessed PPT using an electronic algometer (J Tech Medical Industries, USA). The device had a 1-cm2 hard-rubber probe, which was applied over structures at L1- L5 dermatome at the knee and at the contralateral forearm. The average values of PPT in kgf/cm2 for three successive readings taken at intervals of 3-5 min were used as the outcomes.~# Below, the data after intervention."|Before and within one hour after intervention.||||Kgf / cm2||Standard Deviation|Mean
2630259|NCT01855958|Secondary|Pain Intensity After Intervention.|"The intensity of pain was measured by a 10-cm VAS. VAS scores ranged from no pain (zero) to the worst possible pain possible (10 cm). The pain score on VAS during the last 24 hours was used to classify the subjects into two groups: (1) absence of pain or mild pain (scores equal to or lower than 4 cm) and (2) moderate, intense, or worst possible pain (scores higher than 4 cm).~# Below the data after intervention."|Evaluated within twenty four hours before and within one hour after the intervention.||||cm ( mean).||Standard Deviation|Mean
2630260|NCT01855958|Secondary|Intracortical Inhibition (ICI) After Intervention.|"ICI was evaluated using inter-stimuli intervals (ISIs) of 2 ms with paired-pulse stimulation. The subthreshold stimulus was set at 80% of rMT (conditioning stimulus) , and the suprathreshold test stimulus was set at 130% of rMT. After a randomized protocol, thirty stimuli were assessed using a 2ms interval (ICI), a 12ms interval (ICF) and test-only trials (MEPs). The resulting MEP amplitude was converted into the mean amplitude, and paired-pulse parameters were expressed as the amount of inhibition or facilitation. The calculation result of ICI was done by the ratio of the mean ICI by the mean MEP.~# Below the data after intervention."|Evaluated in one day. The cortical excitability before and within an hour after intervention.||||ratio of amplitude (mV).||Standard Deviation|Mean
2630261|NCT01855945|Secondary|GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.|GMR of post-vaccination versus pre-vaccination HI GMTs following vaccination with H3N2 monovalent vaccine is reported across subjects with age groups 3 to ≥ 61 years.|Day 22/Day 1, Day 43/Day 1, Day183/ Day 1, Day 366/Day 1|Analysis was done on Full Analysis Set.|||Ratios||95% Confidence Interval|Geometric Mean
2630262|NCT01855945|Primary|Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.|The percentages of subjects (3 to ≥ 65 years of age) achieving HI titers ≥1:40 against H3N2 homologous strain at baseline (Day 1) and three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported.|Day 1, Day 22, Day 43 post vaccination|Analysis was done on Full Analysis Set.|||Percentages of Subjects||95% Confidence Interval|Number
2630263|NCT01855945|Secondary|Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.|The percentages of subjects achieving HI titers ≥1:40 against H3N2 homologous strain at three weeks after receiving first (day 22) and second (day 43) vaccination, is reported across age groups of 3 to ≥ 61 years.|Day 1, Day 22, Day 43 post vaccination|Analysis was done on Full Analysis Set.|||Percentages of Subjects||95% Confidence Interval|Number
2630264|NCT01855945|Secondary|Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.|"The percentage of subjects achieving seroconversion or significant increase for HI antibody titers at three weeks after receiving first (Day 22) and second (Day 43) vaccination is reported, across age groups of 3 to ≥61 years.~Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer <1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43."|Day 22, Day 43 post vaccination|Analysis was done on Full Analysis Set.|||Percentages of Subjects||95% Confidence Interval|Number
2630265|NCT01855945|Secondary|Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.|The percentages of subjects (3 to ≥ 65 years of age) demonstrating HI titers ≥1:40 against H3N2 homologous strain on Day 183 and Day 366 post vaccination.|Day 183 and Day 366 post vaccination|Analysis was done on the full analysis set.|||Percentages of Subjects||95% Confidence Interval|Number
2630266|NCT01855945|Secondary|Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.|The geometric mean ratio (GMR) of post versus pre-vaccination HI antibody titers against H3N2 homologous strain following vaccination as compared to baseline titers are reported for after first (Day 22/Day 1) and second (Day 43/Day 1) vaccination and for persisting titers at six months (Day 183/Day1) and one year (Day 366/Day 1) is reported across subjects with age groups 3 to ≥ 65 years.|Day 22/Day 1, Day 43/Day 1, Day 183/Day 1, Day 366/Day 1|Analysis was done on Full Analysis Set.|||Ratios||95% Confidence Interval|Geometric Mean
2630267|NCT01855945|Secondary|Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age).|The HI antibody titers against H3N2 homologous strain at baseline (Day 1), three weeks after first (Day 22) and second (Day 43) vaccination and persisting titers at six months (Day 183) and one year (Day 366) after vaccination are reported in terms of GMTs is reported across subjects with age groups 3 to ≥ 65 years.|Day 1, Day 22, Day 43, Day 183 and Day 366 post vaccination|Analysis was done on Full Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2630406|NCT01854593|Secondary|Intra Operative Hemorrhage|Calculate the number of coagulators for the intra operative hemorrhage.|End of the surgery.||||coagulators||Standard Deviation|Mean
2630268|NCT01855945|Primary|Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.|"The percentages of subjects (3 to ≥ 65 years of age) achieving seroconversion or significant increase in HI antibody titers against H3N2 homologous strain, three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported.~Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer <1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43."|Day 22, Day 43 post vaccination|Analysis was done on Full Analysis Set.|||Percentages of Subjects||95% Confidence Interval|Number
2630269|NCT01855945|Primary|Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.|"The number of subjects reporting any unsolicited adverse events (AEs) from day 1 through day 21 after last vaccination within each vaccine group are reported.~The number of subjects reporting any serious adverse events (SAEs), AEs leading to withdrawal from the study, medically attended AEs, AE of special interest (AESI), new onset chronic disease (NOCDs) from day 1 through day 366, after receiving with H3N2 monovalent vaccine are reported."|Day 1 through Day 366|Analysis was done on unsolicited safety dataset i.e. all subjects in the exposed population who have post-vaccination unsolicited adverse event records.|||Number of subjects|||Number
2630270|NCT01855945|Primary|Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.|Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (≥ 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.|Day 1 through Day 7 after each vaccination|Analysis was done on Solicited Safety Set.|||Number of Subjects|||Number
2630271|NCT01855945|Primary|Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.|Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (18 to < 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.|Day 1 through Day 7 after each vaccination|Analysis was done on Solicited Safety Set.|||Number of Subjects|||Number
2630272|NCT01855945|Primary|Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.|Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (9 to <18 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.|Day 1 through Day 7 after each vaccination|Analysis was done on Solicited Safety Set.|||Number of Subjects|||Number
2630273|NCT01855945|Primary|Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine.|Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (3 to <9 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.|Day 1 through Day 7 after each vaccination|Analysis was done on Solicited Safety Set.|||Number of Subjects|||Number
2630274|NCT01855919|Secondary|Percentage of Participants With Fall Events in Fall Questionnaire|Participants evaluated their experience with and details of falls which were recorded. Percentage = (number of participants with fall events) /(total in treatment group) * 100.|Baseline through Week 14|All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2630275|NCT01855919|Secondary|Number of Participants With Suicidal Thoughts And Behaviors During Study [Columbia Suicide Severity Rating Scale (C-SSRS)]|"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any 1 of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation."|Baseline through Week 14|All randomized participants who received at least 1 dose of study drug, responded no at baseline to the suicide related questionnaire and had data at post-treatment for each question.|||percentage of participants|||Number
2630276|NCT01855919|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Instrument to Week 14|WPAI is a self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities, and yields 4 types of scores: Absenteeism (work time missed)=Question (Q)2/(Q2+4))*100); Presenteeism (impairment at work/reduced on-the-job effectiveness)=(Q5/10)*100); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism)=(Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)])*100); and Activity Impairment=(Q6/10)*100. Scores range from 0 to 1 for each of the above 4 types; higher scores indicate greater impairment. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.|||hours||Standard Error|Least Squares Mean
2630277|NCT01855919|Secondary|Change From Baseline in European Quality of Life Questionnaire-5 Dimension (EQ-5D) to Week 14|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3 level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm ranging from -0.111 to 1.0, with higher scores indicating better quality of life. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-dose BPI pain severity (average pain) scores. LOCF.|||units on a scale||Standard Error|Least Squares Mean
2630286|NCT01855919|Secondary|Patient Global Impression of Improvement (PGI-I) at Week 14|PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse). LS means calculated using MMRM adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.|Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.|||units on a scale||Standard Error|Least Squares Mean
2630422|NCT01854138|Secondary|Number of Participants With Infection||60 days||||Participants|||Count of Participants
2630278|NCT01855919|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) to Week 14|SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2630279|NCT01855919|Secondary|Change From Baseline in Beck Depression Inventory-II (BDI-II) to Week 14|BDI-II is a 21-question multiple-choice self-reported inventory about depressive symptoms (sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping patterns, irritability, changes in appetite, concentration difficulties, tiredness or fatigue, and loss of interest in sex). The scores for each item range from 0 (best) to 3 (worst) with possible total scores of 0 to 63, where higher total scores indicate more severe depressive symptoms. LS means calculated using ANCOVA adjusted for treatment, as fixed effect and baseline as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.|||units on a scale||Standard Error|Least Squares Mean
2630280|NCT01855919|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-Severity) to Week 14|CSI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means calculated using MMRM adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.|||units on a scale||Standard Error|Least Squares Mean
2630281|NCT01855919|Secondary|Percentage of Participants With Sustained Pain Reduction in BPI Average Pain Score|Pain severity was measured using an 11 point BPI scale from 0 (no pain) to 10(worst pain) to determine average pain in the past 24 hours (average pain). Participants were considered to have sustained pain reduction of ≥30% in the BPI-severity score (average pain) at the time of final evaluation and at least 1 other time point prior to the time of final evaluation compared with baseline, and a reduction of ≥20% from baseline sustained at all evaluation time points between that period. Percentage of participants = (number of participants with sustained pain reduction / total number of participants in treatment group) * 100.|Baseline through Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.|||percentage of participants|||Number
2630282|NCT01855919|Secondary|Percentage of Participants With Reduction of ≥30% and ≥50% in BPI Average Pain Score at Week 14|Pain severity was measured using an 11 point BPI scale from 0 (no pain) to 10 (worst pain) to determine average pain in the past 24 hours (average pain). A 30% (or 50%) improvement was defined as a ≥30% (or ≥50%) reduction in BPI pain severity from baseline to endpoint. Percentage of participants = (number of participants with ≥30% or ≥50% pain reduction / total number of participants in treatment group) * 100.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. LOCF was used.|||percentage of participants|||Number
2630283|NCT01855919|Secondary|Change From Baseline in Weekly Mean of 24 Hour Average Pain and Worst Daily Pain Severity Scores to Week 14|24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain). The 11-point Likert scale was also used for assessment of average pain and worst pain within 24-hours. For the analysis, weekly mean was calculated. LS means calculated using MMRM adjusted for treatment, week, interaction between treatment and week as fixed effects and baseline value as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.|||units on a scale||Standard Error|Least Squares Mean
2630284|NCT01855919|Secondary|Change From Baseline in BPI Pain Severity Items (BPI-S) and Interference Items (BPI-I) Scores to Week 14|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores range from: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores range from: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference is defined as the average of non-missing scores of individual interference items. Higher scores indicated worsening of pain. LS means calculated using MMRM adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.|||units on a scale||Standard Error|Least Squares Mean
2630285|NCT01855919|Secondary|Change From Baseline in Roland Morris Disability Questionnaire (RMDQ-24) to Week 14|The RMDQ-24 is a health status measure completed by participants to assess physical disability due to low back pain. Participants answered 24 questions about impairment of daily living activities (standing, walking, sitting, wearing clothes, working, etc.) resulting from low back pain. The number of statements marked was summed by the clinician for a total score. The total scores range from 0 (no disability) to 24 (severe disability). LS means calculated using analysis of covariance (ANCOVA) with treatment group as a fixed effect, and baseline value as a covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores. The last observation carried forward (LOCF) was used.|||units on a scale||Standard Error|Least Squares Mean
2630319|NCT01855126|Primary|Sleep Disturbance|"Pittsburgh Sleep Quality Index. Score range 0 - 21. A score over 5 is indicative of sleep disturbance.~Change in score from baseline to intervention is reported. A larger difference indicates a better outcome."|Baseline (week 0) and week 8 of lighting intervention||||units on a scale||Standard Deviation|Mean
2630287|NCT01855919|Primary|Change From Baseline to Week 14 in Brief Pain Inventory (BPI) 24-Hour Average Pain Severity Item|BPI is a self-reported scale that measures the severity of pain based on the average pain during the past 24-hours. The severity scores ranged from 0 (no pain) to 10 (pain as severe as you can imagine). Higher scores indicated worsening of pain. Least squares (LS) means calculated using mixed model repeating measure (MMRM) adjusted for treatment, visit, interaction between treatment and visit as fixed effects and baseline value as covariate.|Baseline, Week 14|FAS: All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose BPI pain severity (average pain) scores.|||units on a scale||Standard Error|Least Squares Mean
2630288|NCT01855828|Secondary|Residual Cancer Burden Score|To assess cancer burben, the Residual Cancer Burden (RCB) score was used. This score has a range of 0 - III, where III (3) is the worst level of burden.|Up to 28 weeks|Total participants that were analyzed for this score (n=43).|||Participants|||Count of Participants
2630289|NCT01855828|Secondary|Count of Patients With Clinical Response|To assess clinical response according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, the number of patients are presented with a clinical response.|Up to 28 weeks|All patients are assessed by HR-positive or HR-negative status.|||Participants|||Count of Participants
2630290|NCT01855828|Secondary|Cardiac Safety|To assess the safety of the regimen, cardiac safety was measured by rates of clinically symptomatic congestive heart failure, asymptomatic decrease in LVEF >10%, and decrease of LVEF below normal level. This was assessed up to 1 year following surgery.|Up to 1 year post surgery|All patients are assessed in each arm.|||Participants|||Count of Participants
2630291|NCT01855828|Primary|Proportion of Participants With a Pathologic Complete Response Rate|To estimate the pathologic complete response rate (pCR) when pertuzumab is added to weekly trastuzumab/paclitaxel followed by trastuzumab/5-fluorouracil, epirubicin and cyclophosphamide neoadjuvant chemotherapy in HER2-positive breast cancer. This study will assess pCR rates separately in ER+ and ER- cancers. Pathologic complete response is defined as no evidence of viable invasive tumor cells at the primary tumor site and axillary lymph nodes in the surgical specimen. Residual Disease (RD) is defined as: Any invasive cancer in the breast or axillary lymph nodes in the surgical specimen.|20 weeks|For ER-negative cancers, the maximum sample size was set to n = 25 and the regimen would be considered of interest if > 20 patients achieve pCR. For ER-positive patients, the maximum sample size for the ER-positive cohort was set to 39 and the regimen would be considered of interest in this subgroup if > 23 patients achieve pCR.|||proportion of participants||95% Confidence Interval|Number
2630292|NCT01855789|Secondary|Mean Soluble Interleukin-6 (IL-6) Receptor Concentration||Baseline, Weeks 12, 24, 36, 52 and follow up (Week 60)|Analysis was performed on safety population. The analysis included overall study population and was not intended to compare the 2 randomized groups. ‘Number Analyzed’ = number of participants with assessment at specified time points.|||nanograms per milliliter||Standard Deviation|Mean
2630293|NCT01855789|Secondary|Mean TCZ Serum Concentration||Baseline, Weeks 12, 24, 36, 52 and follow up (Week 60)|Analysis was performed on safety population. The analysis included overall study population and was not intended to compare the 2 randomized groups. ‘Number Analyzed’ = number of participants with assessment at specified time points.|||micrograms per milliliter||Standard Deviation|Mean
2630294|NCT01855789|Secondary|Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to TCZ|Percentage of participants with positive results for ATA against TCZ at Baseline and at any of the post-baseline assessment time-points was reported. Participants positive at any post-baseline time points were participants who had no positivity at baseline for the same assay.|Baseline, Post-baseline (assessed at Weeks 12, 24, 36, 52 and at follow up [Week 60])|Analysis was performed on safety population which included all participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. The analysis included overall study population and was not intended to compare the 2 randomized groups. ‘Number Analyzed’ = participants with ATA assessment at specified time points.|||percentage of participants|||Number
2630295|NCT01855789|Secondary|Change From Week 24 in Bone Erosion Score at Week 40 for Participants in the Magnetic Resonance Imaging (MRI) Substudy|Bones from the wrist regions (carpal bones, distal radius, distal ulna, and metacarpal bases) and the metacarpophalangeal (MCP) joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranged from 0 (no erosion) to 10 (91-100%). Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value for change from Week 24 in bone erosion score indicated an improvement.|Weeks 24, Week 40|Analysis was performed on MRI subset which included all participants in the randomized group who passed MRI eligibility requirements and who had an MRI performed on or after the Week 24 visit. Here, ‘Number Analyzed’ signifies participants with assessment at specified time point.|||units on a scale||Standard Deviation|Mean
2630296|NCT01855789|Secondary|Percentage of Participants With DAS28 Score </=3.2 (Low DAS28)|The DAS28 was derived from assessments of ESR measured in mm/h, TJC28, SJC28, and Patient's global assessment of disease activity according to 100-mm VAS. DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28-ESR score could range from 0 to 10, where higher score represented higher disease activity.|Week 40, Week 52|Analysis was performed on randomized group. Missing assessments of DAS28 were treated as no response.|||percentage of participants|||Number
2630297|NCT01855789|Secondary|Percentage of Participants With DAS28 Score <2.6 (DAS28 Remission)|The DAS28 was derived from assessments of ESR measured in mm/h, TJC28, SJC28, and Patient's global assessment of disease activity according to 100-mm VAS. DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity.|Week 40, Week 52|Analysis was performed on randomized group. Missing assessments of DAS28 were treated as no response.|||percentage of participants|||Number
2630337|NCT01854944|Secondary|Peak (Maximal) Concentration of Drug in Plasma (Cmax) for Brexpiprazole and Its Metabolite DM-3411|(Cmax) Days 1 and 9: predose (within 15 minutes prior to dosing) Day 10: predose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 8, and 12 hours post-last dose.|Baseline to Day 10|The PK analysis included participants who had valid measurements (per clinical pharmacology). Blood samples were collected on Days 1 and 9 at predose and Day 10 at predose and at 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-last dose or at ET.|||ng/mL||Standard Deviation|Mean
2630298|NCT01855789|Secondary|Percentage of Participants With >/=1.2 Points Increase (Worsening) From Week 24 in DAS28 Score at Week 40 and 52|The DAS28 was derived from assessments of ESR measured in mm/h, TJC28, SJC28, and Patient's global assessment of disease activity according to 100-mm VAS. DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28- score could range from 0 to 10, where higher score represented higher disease activity.|Week 24, 40, and 52|Analysis was performed on randomized group. Missing assessments of DAS28 were treated as worsening.|||percentage of participants|||Number
2630299|NCT01855789|Secondary|Percentage of Participants Achieving 70% Improvement in American College of Rheumatology (ACR70) Response|The ACR70 response at any time was defined as >/=70% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 70% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).|Weeks 24, 40, and 52|Analysis was performed on randomized group. Missing assessments of response were treated as no response.|||percentage of participants|||Number
2630300|NCT01855789|Secondary|Percentage of Participants Achieving 50% Improvement in American College of Rheumatology (ACR50) Response|The ACR50 response at any time was defined as >/=50% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 50% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).|Weeks 24, 40, and 52|Analysis was performed on randomized group. Missing assessments of response were treated as no response.|||percentage of participants|||Number
2630301|NCT01855789|Secondary|Percentage of Participants Achieving 20% Improvement in American College of Rheumatology (ACR20) Response|The ACR20 response at any time was defined as >/=20% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 20% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via a Health Assessment Questionnaire-Disability Index (HAQ-DI), and 5) Acute phase reactant (ESR in mm/h or C-Reactive Protein [CRP] in milligrams per deciliter [mg/dL]).|Weeks 24, 40, and 52|Analysis was performed on randomized group. Missing assessments of response were treated as no response.|||percentage of participants|||Number
2630302|NCT01855789|Primary|Change From Week 24 in Disease Activity Score Based on 28 Joints (DAS28) Score at Week 40|The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR) measured in millimeters per hour (mm/h), tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), and Patient's Global Assessment of disease activity according to 100--millimeter (mm) Visual Analog Scale (VAS). DAS28 score was calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity. The change from Week 24 to Week 40 was averaged among all participants, where negative changes indicated an improvement in disease activity.|Week 24, Week 40|Analysis was performed on randomized group which included participants in ITT population who were randomized and received blinded treatment at Week 24. Missing Week 40 values were imputed using last available assessment obtained after Week 24. Here, ‘Number Analyzed’ signifies number of participants with assessment at specified time point.|||units on a scale||Standard Deviation|Mean
2630303|NCT01855750|Secondary|Time to Worsening in the Lymphoma Subscale of Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)|Time to worsening in the Lymphoma subscale of the FACT-Lym, defined as the interval from the date of randomization to the start date of worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (higher the worse). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life.|Up to approximately 4.5 years|ITT population included all randomized participants, who were enrolled with the non-GCB of DLBCL subtype by IHC. Participants in this population were analyzed according to the treatment to which they were randomized.|||Months||95% Confidence Interval|Median
2630304|NCT01855750|Secondary|Overall Survival|Overall survival was defined as the duration from the date of randomization to the date of the participant's death. Median Overall Survival was estimated by using the Kaplan-Meier method.|Up to 5.5 years|ITT population included all randomized participants, who were enrolled with the non-GCB of DLBCL subtype by IHC. Participants in this population were analyzed according to the treatment to which they were randomized.|||Months||95% Confidence Interval|Median
2630305|NCT01855750|Secondary|Percentage of Participants Who Achieved Complete Response (CR)|Percentage of participants with measurable disease who achieved CR were reported. CR: disappearance of all evidence of disease. CR Criteria: Complete disappearance of all disease-related symptoms; all lymph nodes and nodal masses regressed to normal size (less than or equal to [<=]1.5 cm in greatest transverse diameter [GTD] for nodes greater than [>]1.5 cm before therapy). Previous nodes of 1.1 to 1.5 cm in long axis and greater than (>)1.0 cm in short axis before treatment decreased to <=1.0 cm in short axis after treatment. Disappearance of all splenic and hepatic nodules and other extranodal disease; a negative positron emission tomography (PET) scan. A posttreatment residual mass of any size but PET-negative; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy.|Up to approximately 4.5 years|ITT population included all randomized participants, who were enrolled with the non-GCB of DLBCL subtype by IHC. Participants in this population were analyzed according to the treatment to which they were randomized.|||Percentage of participants|||Number
2630356|NCT01854827|Primary|Feasibility of IVIG Treatment|Percentage of subjects for whom administration of IVIG is feasible, defined as the successful administration (at least 80% of each dose) of all 3 doses of IVIG|60 days post-HPE|MITT|||Participants|||Count of Participants
2630423|NCT01854138|Primary|Number of Participants With Hospital Readmissions||60 days||||Participants|||Count of Participants
2630306|NCT01855750|Secondary|Progression-Free Survival (PFS)|PFS was defined as the duration from the date of randomization to the date of progression, relapse from CR, or death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. Progressive Disease (PD): any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 centimeter (cm) in any axis, 50% increase in SPD of >1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy.|Up to approximately 4.5 years|ITT population included all randomized participants, enrolled with non-GCB of DLBCL subtype by IHC, and were analyzed according to treatment to which they were randomized.|||Months||95% Confidence Interval|Median
2630307|NCT01855750|Primary|Event-Free Survival (EFS) - Activated B-Cell (ABC) Population|EFS: duration from randomization date to PD date, relapse from CR assessed by investigator, initiation of subsequent systemic antilymphoma therapy for either PET-positive/ biopsy-proven residual disease upon completion of >=6 cycles of R-CHOP therapy/death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. PD: any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in SPD of >1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy.|Up to approximately 4.5 years|ABC population included ITT population (all randomized participants, enrolled with non-GCB of DLBCL subtype by IHC) having ABC subtype determined by gene expression profiling (GEP) (retrospectively determined from available formalin-fixed paraffin-embedded [FFPE] tissue specimens). Participants were analyzed according to randomized treatment.|||Months||95% Confidence Interval|Median
2630308|NCT01855750|Primary|Event-Free Survival (EFS) - Intent-to-Treat (ITT) Population|EFS: duration from randomization date to disease progression(PD) date, relapse from complete response(CR) assessed by investigator, initiation of subsequent systemic antilymphoma therapy for either positron emission tomography(PET)-positive/ biopsy-proven residual disease upon completion of >=6 cycles of R-CHOP therapy/death, whichever occurred first. Responses were based on Revised Response Criteria for Malignant Lymphoma. PD: any new lesion or increase by 50% of previously involved sites from nadir; PD criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in sum of product of diameters(SPD) of >1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. CR: disappearance of all evidence of disease; CR criteria: nodal masses PET positive prior to therapy; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy.|Up to 5.5 years|Intent-to-Treat (ITT) population included all randomized participants, enrolled with non-germinal center B-cell (GCB) of diffuse large B-cell lymphoma (DLBCL) subtype by immunohistochemistry (IHC), and were analyzed according to treatment to which they were randomized.|||Months||95% Confidence Interval|Median
2630309|NCT01855425|Primary|Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale|"Percentage of Participants with >=3 Diagnostic Rating Using Radlex Scale. Five radiologists participated in reader study using Radlex scale below to analyze and rate participant images. They determined if they could make a medical diagnosis for ENT patients.~Used Radlex Scale - 1-Non-diagnostic, Unacceptable for diagnostic purposes. 2-Limited Acceptable, with some technical defect. 3-Diagnostic, Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary, Good most adequate for diagnostic purposes."|11 months|96 participants were imaged for this study, but only 76 participant image pairs were analyzed in the reader study. 20 participant image pairs were disqualified by the physicians due movement/unclear image quality.|||percentage of participants||Standard Deviation|Mean
2630310|NCT01855399|Primary|Percent Glycosylated Hemoglobin|Percent glycosylated hemoglobin is measured at baseline, 6 months, and 12 months to test the effectiveness of a technology-enhanced peer coaching (TEC) program in improving glucose control relative to peer support alone.|6 Month||||Percent glycosylated hemoglobin||Standard Deviation|Mean
2630311|NCT01855243|Primary|Mean BG After First Day of Hospitalization||after first day of hospitalization||||mg/dL||Standard Deviation|Mean
2630312|NCT01855243|Secondary|Mortality Rate||during the hospital stay which is expected to be average 3 weeks||||participants|||Number
2630313|NCT01855243|Secondary|Number of Patients Developed Episodes of Severe Hyperglycemia|Hyperglycemic events are defined as BG > 300 mg/dL.|during hospital stay which is expected to be average 3 weeks||||participants|||Number
2630314|NCT01855243|Secondary|Number of Patients Developed Hypoglycemic Events|Hypoglycemic episodes are classified as major (BG ≤ 40 mg/dL or associated with impaired mental status or loss of consciousness), or minor (BG between 40 and 59 mg/dL) events.|during hospital stay which is expected to be average 3 weeks||||participants|||Number
2630315|NCT01855243|Primary|Mean Daily Blood Glucose (BG) Concentration During Their Hospital Stay.||during hospital stay which is expected to be average 3 weeks||||mg/dL||Standard Deviation|Mean
2630316|NCT01855126|Primary|Sleep Start Time|Change in sleep start time, in minutes, from baseline week to the last week of intervention. A higher number is a better outcome. Based on actigraph data|baseline week (week 0) and the last week of intervention (week 8)||||minutes||Standard Deviation|Mean
2630317|NCT01855126|Primary|Sleep Efficiency|The change in sleep efficiency from baseline to last week of intervention. A higher number is a better outcome. Sleep efficiency is the percentage of time spent in bed sleeping. Scored total sleep time divided by interval duration minus total invalid time (sleep/wake) of the given rest interval multiplied by 100. This data was collected using actigraphy data.|baseline week (week 0) and the last week of intervention (week 8)||||percentage of sleep||Standard Deviation|Mean
2630318|NCT01855126|Primary|Total Sleep Time|The change in total amount of minutes spent sleeping at night from baseline week to the last week of intervention. A higher number is an improved outcome|baseline week (week 0) and the last week of intervention (week 8)||||minutes||Standard Deviation|Mean
2633193|NCT01828112|Secondary|Duration of Response (DOR)|DOR is defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to underlying cancer|Month 18||2023-07-31|07/2023||||
2630320|NCT01855074|Secondary|Extrapyramidal Symptom Rating Scale (ESRS) Score|An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, absent) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.|Baseline and Week 26|Safety set (SS) population (N=79) included all participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
2630321|NCT01855074|Secondary|Patient Satisfaction With Treatment|Participants' were assessed for their satisfaction with the current antipsychotic treatment on a 5-point scale/questionnaire: very good, good, reasonable, moderate or poor.|Baseline and Week 26|The ITT population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.|||Participants|||Number
2630322|NCT01855074|Secondary|Global Assessment of Functioning (GAF) Score|The GAF is a 100-point tool to measure overall psychological, social and occupational functioning of adults. The higher score range (91 to 100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1 to 10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|Baseline and Week 26|The ITT population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.|||Units on a scale||Standard Deviation|Mean
2630323|NCT01855074|Secondary|Short Form-36 (SF-36) - Quality of Life Score|The SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: vitality, physical function, social function, physical role, emotional role, bodily pain, general health, mental health. Each item is scored on a scale ranging from 0-100 (100=highest level of functioning).|Baseline and Week 26|The ITT population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point.|||Units on a scale||Standard Deviation|Mean
2630324|NCT01855074|Secondary|Clinical Global Impressions (CGI) - Disease Severity Score|"The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants, higher scores indicate worsening."|Baseline and Week 26|The Intent-to-treat (ITT) population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here 'n' signifies number of participants evaluable for this outcome measure at specific time point.|||Units on a scale||Standard Deviation|Mean
2630325|NCT01855074|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening. Change at Week 26 score is calculated as Baseline score minus Week 26 score.|Baseline and Week 26|The Intent-to-treat (ITT) population included all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit. Here 'n' signifies number of participants evaluable for this outcome measure at specific time point.|||Units on a scale||Standard Deviation|Mean
2630326|NCT01854944|Secondary|Mean Change From Baseline in Clinical Global Impression-Improvement (CGI-I) Score|The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse. Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
2630327|NCT01854944|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. Last Visit is the last scheduled post-baseline evaluation including early termination evaluation."|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
2630328|NCT01854944|Secondary|Mean Change From Baseline in PANSS Negative Subscale Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
2630358|NCT01854710|Secondary|Subjects With QTcI Increase > 60 ms From Baseline|Numbers of Subjects with QTcI Increase > 60 ms From Baseline at any time point|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- Comparisons were based on corrected differences between Adasuve and placebo (excluding moxifloxacin) exposure per ICH Guideline E14 for a thorough QT study.|||Participants|||Count of Participants
2630329|NCT01854944|Secondary|Mean Change From Baseline in PANNS Positive Subscale Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
2630330|NCT01854944|Secondary|Mean Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety sample included participants that are administered at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
2630331|NCT01854944|Secondary|Percentage of Participants Who Reported at Least One Occurrence of Suicidality, Suicidal Behavior and Suicidal Ideation on the Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). The suicidal ideation intensity total score is the sum of intensity scores of 5 items (frequency, duration, controllability, deterrents, and reasons for ideation). The score of each intensity item ranges from 0 (none) to 5 (worst) which leads to the range of the total score from 0 to 25, with a higher score indicating a worse outcome. A missing score of any item resulted in a missing total score. If no suicidal ideation was reported, a score of 0 was given to the intensity scale. Last Visit is last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Last Visit|The safety population included all participants who received at least one dose of study medication.|||Percentage of participants|||Number
2630332|NCT01854944|Secondary|Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score|The BARS consisted of 4 items related to akathisia: objective observation of akathisia by the study physician, subjective feelings of restlessness by the participant, participant distress due to akathisia, and global evaluation of akathisia. The first 3 items were rated on a 4-point scale, with a score of 0 = absence of symptoms and a score of 3 = severe condition. The global clinical evaluation were made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe). To complete this scale, participants were observed while they were seated and then stood for a minimum of 2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral conversation or engaged in activity on the ward) may also be rated. Subjective phenomena were to be elicited by direct questioning. The BARS total score (when combined) ranged from 0 to 18, with higher values indicating a severe condition.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
2630333|NCT01854944|Secondary|Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score|The SAS is a rating scale used to measure EPS. The SAS scale consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40, with higher scores indicating worse outcome. Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.|||Units on scale||Standard Deviation|Mean
2630334|NCT01854944|Secondary|Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score|The AIMS Scale was an extrapyramidal symptoms (EPS) rating scale. The AIMS is a 12 item scale. The first 10 items e.g. facial and oral movements (items 1-4), extremity movements (items 5 and 6), trunk movements (item 7), investigators global assessment of dyskinesia (items 8 to 10). The first 10 items are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28, with a higher score indicating worse outcome. Last Visit is the last scheduled post-baseline evaluation including early termination evaluation.|Baseline to Day 6, 11 and Last Visit|The safety population included all participants who received at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
2630335|NCT01854944|Secondary|Time to Maximum (Peak) Plasma Concentration (Tmax) for Brexpiprazole and Its Metabolite DM-3411|Tmax for brexpiprazole and its metabolite DM-3411. Days 1 and 9: predose (within 15 minutes prior to dosing) Day 10: predose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 8, and 12 hours post-last dose.|Baseline to Day 10|The PK analysis included participants who had valid measurements (per clinical pharmacology). Blood samples were collected on Days 1 and 9 at predose and Day 10 at predose and at 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-last dose or at ET.|||hour||Full Range|Median
2630336|NCT01854944|Secondary|Apparent Clearance of Drug From Plasma After Extravascular Administration (CL/F; Only Brexpiprazole)|PK parameter - CL/F was assessed for brexpiprazole only. Days 1 and 9: predose (within 15 minutes prior to dosing) Day 10: predose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 8, and 12 hours post-last dose.|Baseline to Day 10|The PK analysis included participants who had valid measurements (per clinical pharmacology). Blood samples were collected on Days 1 and 9 at predose and Day 10 at predose and at 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-last dose or at ET.|||mL/hr||Standard Deviation|Mean
2633194|NCT01828112|Secondary|Overall Response Rate (ORR)|ORR is defined as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR); (CR+PR)|Month 18||2023-07-31|07/2023||||
2630338|NCT01854944|Secondary|Area Under the Concentration-time Curve (AUCτ) During a Dosing Interval at Steady-state for Brexpiprazole and Its Metabolite DM-3411|AUC during a dosing interval at steady-state for brexpiprazole and its metabolite DM-3411. Days 1 and 9: predose (within 15 minutes prior to dosing) Day 10: predose (within 15 minutes prior to dosing) and 1, 2, 3, 4, 5, 6, 8, and 12 hours post-last dose.|Baseline to Day 10|The PK analysis included participants who had valid measurements (per clinical pharmacology). Blood samples were collected on Days 1 and 9 at predose and Day 10 at predose and at 1, 2, 3, 4, 5, 6, 8, 12, and 24 hours post-last dose or at early termination (ET).|||hr*ng/mL||Standard Deviation|Mean
2630339|NCT01854944|Primary|Change in Occupancy at Serotonin Transporter (SERT)|Mean (±SD) SERT Occupancy Using the Radiotracer [11C]DASB in high dose only. Occupancy estimates were averaged across brain regions 4 hours post-last dose.|Baseline to 4 hours post-last dose on Day 10|The PET analysis included all participants who had both the Baseline and Day 10 PET scans performed.|||percentage occupancy||Standard Deviation|Mean
2630340|NCT01854944|Primary|Change in Percentage 5-HT2A Receptor Occupancy|Mean (±SD) Serotonin 5-HT2A Receptor Occupancy Using the Radiotracer [11C]MDL100907 (in low and high dose). The 5-HT2A receptors following administration of 1- and 4-mg doses of brexpiprazole were assessed and the occupancy estimates were averaged across brain regions 4 hours post-last dose on Day 10.|Baseline and 4 hours post-last dose on Day 10|The PET analysis included all participants who had both the Baseline and Day 10 PET scans performed.|||percentage occupancy||Standard Deviation|Mean
2630341|NCT01854944|Primary|Change in Percentage 5-HT1A Receptor Occupancy|Mean (±SD) Serotonin 5-HT1A Receptor Occupancy Using the Radiotracer [11C]CUMI101 in high dose only. In cohorts 1, 2 and 3, the binding of brexpiprazole to the 5-HT1A receptors was assessed by comparing the binding potential from the Baseline scan (prior to treatment) to that of Day 10 (after treatment). The 5-HT1A receptors following administration of a 4-mg dose of brexpiprazole was assessed and the occupancy estimates were averaged across brain regions 4 hours post-last dose on Day 10.|Baseline to 4 hours post-last dose on Day 10|The PET analysis included all participants who had both the Baseline and Day 10 PET scans performed.|||percentage occupancy||Standard Deviation|Mean
2630342|NCT01854944|Primary|Change in Percentage Dopamine D2/D3 Receptor Occupancy|Dopamine receptor occupancy measured using the radiotracer [11C]-(+)-PHNO in low and high dose. The binding of brexpiprazole to the D2/D3 receptors were assessed by comparing the binding potential from the Baseline scan (prior to treatment) to that of Day 10 (after treatment). The D2/D3 receptors following administration of a 1- and 4-mg doses of brexpiprazole were assessed and the occupancy estimates were averaged across brain regions 4 hours post-last dose on Day 10.|Baseline to 4 hours post-last dose on Day 10|The positron emission tomography (PET) analysis included all participants who had both the Baseline and Day 10 PET scans performed.|||percentage occupancy||Standard Deviation|Mean
2630343|NCT01854918|Secondary|Change From Baseline in LDL-C at Weeks 48 and 104||Baseline of the parent study and weeks 48 amd 104|Participants who were randomized in 20120138 and on-study and with known dosing information in the All-IP period, and with non-missing data at each time point.|||mg/dL||Standard Deviation|Mean
2630344|NCT01854918|Secondary|Percent Change From Baseline in LDL-C at Weeks 48 and 104||Baseline of the parent study and weeks 48 amd 104|Participants who were randomized in 20120138 and on-study and with known dosing information in the All-IP period, and with non-missing data at each time point.|||percent change||Standard Deviation|Mean
2630345|NCT01854918|Primary|Number of Participants With Adverse Events|Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.0, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.|48 weeks in the SOC-controlled period and up to 2 years in the All-IP period|All randomized participants (year 1) and randomized participants on study and who received at least 1 dose of evolocumab in the all-IP period (years 2-3).|||Participants|||Count of Participants
2630346|NCT01854905|Primary|Percentage of Patients in Each Category of the Dry Eye Workshop Severity (DEWS) Scale|The severity of each patient's dry eye was classified by the physician according to the DEWS scale. Categories are: mild and/or episodic, occurs under environmental stress; moderate episodic or chronic, stress or no stress; and severe frequent or constant without stress|Day 1|All enrolled patients|||Percentage of Patients|||Number
2630347|NCT01854827|Secondary|Circulating Regulatory T-Cells, Inflammatory Cytokines, and Specific Autoantibodies.|Percentage and absolute number of Tregs (CD4+CD25+FoxP3+), CD3/4 T cells, CD3/8 T cells, NK cells (CD56), NK T cells (CD3/56), CD19/20 B cells, macrophages (CD14/11b), and neutrophils; plasma levels of anti-enolase antibody; and plasma cytokine levels (Th1/Th2 multiplex and IL17)|Over 360 days after HPE||2019-10-31|10/2019||||
2630348|NCT01854827|Secondary|Transplant-free Survival|Percentage of subjects who survive with their native liver at 360 days after HPE.|360 days post-HPE|mITT|||Participants|||Count of Participants
2630349|NCT01854827|Secondary|Good Bile Drainage at 360 Days Post-HPE|Percentage of subjects who survive 360 days after HPE with both their native liver and serum total bilirubin <1.5 mg/dL at 360 days after HPE|360 days post-HPE|mITT|||Participants|||Count of Participants
2630350|NCT01854827|Secondary|Good Bile Drainage at 180 Days Post-HPE|Percentage of subjects who survive 180 days after HPE with both their native liver and serum total bilirubin <1.5 mg/dL at 180 days after HPE|180 days post-HPE|mITT|||Participants|||Count of Participants
2630351|NCT01854827|Secondary|Good Bile Drainage at 90 Days Post-HPE|Percentage of subjects who survive 90 days after HPE with both their native liver and serum total bilirubin <1.5 mg/dL at 90 days after HPE|90 days post-HPE|mITT|||Participants|||Count of Participants
2630352|NCT01854827|Primary|Adverse Events|Percentage of subjects with other expected adverse events|360 days post-HPE|mITT|||Participants|||Count of Participants
2630353|NCT01854827|Primary|Level 3-5 Toxicity|Percentage of subjects with any level 3, 4, or 5 toxicity (per NCI CTEP grading system)|360 days post-HPE|mITT|||Participants|||Count of Participants
2630354|NCT01854827|Primary|Serious Adverse Events|Percentage of subjects with any serious adverse events (SAEs) prior to liver transplant|360 days post-HPE|mITT|||Participants|||Count of Participants
2630355|NCT01854827|Primary|Acceptability of IVIG|Percentage of subjects for whom the study is acceptable, defined as the ability of the subject's family or guardian to allow intravenous line placements, blood draws, and other study procedures for the study subjects.|60 days post-HPE|MITT|||Participants|||Count of Participants
2630359|NCT01854710|Secondary|Subjects With QTcI Increase > 30 ms From Baseline|Numbers of Subjects with QTcI Increase > 30 ms from Baseline at any time point|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- Comparisons were based on corrected differences between Adasuve and placebo (excluding moxifloxacin) exposure per ICH Guideline E14 for a thorough QT study.|||Participants|||Count of Participants
2630360|NCT01854710|Secondary|Subjects With QTcI > 480 ms|Numbers of Subjects with QTcI > 480 ms (or 500 ms) at any time point|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- Comparisons were based on corrected differences between Adasuve and placebo (excluding moxifloxacin) exposure per ICH Guideline E14 for a thorough QT study.|||Participants|||Count of Participants
2630361|NCT01854710|Secondary|Subjects With QTcI > 450 ms|Numbers of Subjects with QTcI > 450 ms at any time point|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- Comparisons were based on corrected differences between Adasuve and placebo (excluding moxifloxacin) exposure per ICH Guideline E14 for a thorough QT study.|||Participants|||Count of Participants
2630362|NCT01854710|Secondary|QTc Versus Loxapine Concentration|QTc @ Cmax based on linear and nonlinear regression of QTcI versus time matched serum loxapine concentrations|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- LSM and CI statistics were based on the individual (within subject) corrected differences between Adasuve and placebo exposures per ICH Guideline E14 for a thorough QT study.|||msec||95% Confidence Interval|Least Squares Mean
2630363|NCT01854710|Primary|Maximum Effect of ADASUVE on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo|Time-matched differences in QTcI values between the maximum of the mean difference from baseline of the QTcI interval after time-matched placebo subtraction for ADASUVE treatment at 12 post-inhalation times.|Predose, 2 min, 1, 1.5 hr, 2 hr 2 min, 2 hr 5 min, 2.5, 3, 5, 8, 12, and 24 hr|QT population -- LSM and CI statistics were based on the individual (within subject) corrected differences between Adasuve and placebo exposures per ICH Guideline E14 for a thorough QT study.|||msec||95% Confidence Interval|Least Squares Mean
2630364|NCT01854697|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)|The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 24 weeks after the last dose of study drug.|24 weeks after the last actual dose of active study drug|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2630365|NCT01854697|Secondary|Percentage of Participants With Post-treatment Relapse|Hepatitis C virus (HCV) ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (LLOQ) between the end of treatment and 24 weeks post treatment among participants completing treatment and with HCV RNA less than the LLOQ at the end of treatment.|Within 24 weeks post treatment|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug and had sustained virologic response at Week 24 (SVR24).|||percentage of participants|||Number
2630366|NCT01854697|Secondary|Percentage of Participants With Virologic Failure During Treatment|"Participants in Arms A, C or D demonstrating any of the following were considered virologic failures and discontinued therapy:~Confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements of >1 log10 IU/mL above nadir) at any time point during treatment~Failure to achieve HCV RNA < LLOQ by Week 6 or~Confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) at any point after HCV RNA < LLOQ during treatment after HCV RNA < LLOQ.~Participants in Arms B and E followed virologic stopping criteria described in the TPV Summary of Product Characteristics; they were considered virologic failures and discontinued therapy as follows:~HCV RNA > 1000 IU/mL at Week 4 to Week 12, discontinue TPV and pegIFN and RBV~HCV RNA > 1000 IU/mL at Week 12, discontinue pegIFN and RBV~Confirmed HCV RNA > lower limit of detection (LLOD) at Week 24, discontinue pegIFN and RBV~Confirmed HCV RNA > LLOD at Week 36, discontinue pegIFN and RBV."|12 weeks for Arms A, C and D and 24 weeks or 48 weeks for Arms B and E|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2630367|NCT01854697|Secondary|Percentage of Participants With SVR12 - Secondary Efficacy Analyses|The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2630368|NCT01854697|Secondary|Mean Change From Baseline to the Final Treatment Visit in SF-36V2 Physical Component Summary (PCS)|SF-36V2 is a generic 36-item questionnaire measuring HRQoL covering 2 summary measures: PCS and MCS; it consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. Participants self-report on items in a subscale that have choices per item. Scoring is done for both PCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL).|From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug and a baseline and post-baseline value.|||units on a scale||Standard Deviation|Mean
2630369|NCT01854697|Secondary|Mean Change From Baseline to the Final Treatment Visit in Short-Form 36 Version 2 Health Status Survey (SF-36V2) Mental Component Summary (MCS)|SF-36V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQoL) covering 2 summary measures: physical component summary (PCS) and MCS; it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL).|From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug and a baseline and post-baseline value.|||units on a scale||Standard Deviation|Mean
2630370|NCT01854697|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2630373|NCT01854658|Secondary|St. George Respiratory Questionnaire (SGRQ) Score|Change from baseline in the SGRQ total score at Week 24. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.|24 weeks|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2630374|NCT01854658|Secondary|Peak FEV1|Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24|At week 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.|||Liters||95% Confidence Interval|Least Squares Mean
2630375|NCT01854658|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks|Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.|Over 24 weeks|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.|||Liters||95% Confidence Interval|Least Squares Mean
2630376|NCT01854658|Primary|Change From Baseline in Morning Pre-dose Trough FEV1|Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24.|At Week 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.|||Liters||95% Confidence Interval|Least Squares Mean
2630377|NCT01854645|Secondary|Peak Change From Baseline in FEV1 Within 2 Hours Post-dose|Peak change from baseline in forced expiratory volume in 1 second (FEV1) within 2 hours post-dose|Baseline and at Week 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure|||Liters||95% Confidence Interval|Least Squares Mean
2630378|NCT01854645|Secondary|Onset of Action as Assessed by FEV1|Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant|Assessed for 5- and 15-minute post dose on Day 1|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure|||Liters||95% Confidence Interval|Least Squares Mean
2630379|NCT01854645|Secondary|Rescue Ventolin Hydrofluoroalkane (HFA) Use|Change from baseline in average daily rescue Ventolin HFA use|Baseline and at Week 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure|||Puffs / Day||95% Confidence Interval|Least Squares Mean
2630380|NCT01854645|Secondary|St. George's Respiratory Questionnaire (SGRQ) Score|Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.|Baseline and at Week 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2630381|NCT01854645|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks|Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline,and a modelbased average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.|Baseline and Weeks 2 to 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure|||Liters||95% Confidence Interval|Least Squares Mean
2630382|NCT01854645|Primary|Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24|Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24|Baseline and at Week 24|Intent-to-Treat population with evaluable data (no imputation) for this outcome measure|||Liters||95% Confidence Interval|Least Squares Mean
2630383|NCT01854632|Secondary|Evaluation of Vaccine-take as Shedding of Vaccine Virus Post-vaccination, Including Viral Load and Duration of Virus Detection|Vaccine take will be parameterized as the percentage of participants with detectable vaccine-virus in nasal or throat swab on each day pre- (day 0) and post vaccination (i.e., 2 and 4 days post vaccination), and the quantity of detected virus.|Through 4 days post vaccination|||||||
2630384|NCT01854632|Secondary|Etiologies of Influenza-like Illness in the Study Population|Bacterial and viral etiologies of acute respiratory and febrile illness will be parameterized as the percentage of those with each particular laboratory-confirmed infection categorized by vaccine allocation.|Through 7 to 8 months post vaccination|||||||
2630385|NCT01854632|Secondary|Clinical Characteristics of Influenza in the Study Population||Through 7 to 8 months post vaccination|||||||
2630386|NCT01854632|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection by Influenza Type/Subtype (Influenza A/H1N1, Influenza A/H3N2, and Influenza B)||Through 7 to 8 months post vaccination|||||||
2630387|NCT01854632|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains)||Through 7 to 8 months post vaccination|||||||
2630388|NCT01854632|Secondary|Safety Profile of LAIV: Protocol Defined Wheezing Illness||Through 7 to 8 months post vaccination|||||||
2630389|NCT01854632|Secondary|Safety Profile of LAIV: Other Non-serious Adverse Events||Through 1 month post vaccination|||||||
2630390|NCT01854632|Secondary|Safety Profile of LAIV: Serious Adverse Events||Through 1 month post vaccination|||||||
2630391|NCT01854632|Secondary|Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions||Through 7 days post vaccination|||||||
2630392|NCT01854632|Secondary|Safety Profile of LAIV: Immediate Reactions Occurring Within 30 Minutes of Administration of Study Vaccine.||Through 30 minutes post vaccination|||||||
2630407|NCT01854528|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period.|Between end of treatment (Week 12 for 3-DAA/RBV and Week 24 or 48 for TPV/RBV) and Post-treatment (up to Week 12 Post-treatment)|ITT population.|||percentage of participants||95% Confidence Interval|Number
2630408|NCT01854528|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as HCV ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (≥ LLOQ) after HCV RNA < LLOQ during treatment or confirmed HCV RNA ≥ LLOQ at the end of treatment.|Baseline to end of treatment (12 weeks for 3-DAA/RBV and 24 or 48 weeks for TPV/RBV)|ITT population.|||percentage of participants||95% Confidence Interval|Number
2630409|NCT01854528|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 24 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.|24 weeks after the last dose of study drug|All participants in the ITT population with evaluable data.|||percentage of participants|||Number
2630410|NCT01854528|Secondary|Mean Change From Baseline to Final Treatment Visit in the Physical Component Summary (PCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2)|The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into a PCS score (range = 0 to 100; a higher score indicates better mental function and well-being).|Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV)|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
2630411|NCT01854528|Secondary|Mean Change From Baseline to Final Treatment Visit in the Mental Component Summary (MCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2)|The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into an MCS score (from 0 to 100; a higher score indicates better mental function and well-being).|Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV)|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
2630412|NCT01854528|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.|12 weeks after the last dose of study drug|ITT population: All randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2630413|NCT01854281|Primary|Arterial Nitrogen Bubbles After Surfacing|Arterial gas bubbles are detected by transcranial doppler ultrasonography. Positive outcome is 1 or more bubbles detected.|assesed within 1 hour after surfacing||||participants|||Number
2630414|NCT01854268|Secondary|Urge-to-cough|Urge-to-cough: A measure of respiratory sensation that rates the perceived magnitude of the need to cough on a Borg scale (0=no urge-to-cough; 10=maximal urge-to-cough).|1 hour||||units on a scale||Standard Error|Median
2630415|NCT01854268|Secondary|Peak Expiratory Airflow Rate|Airflow measures: Peak expiratory airflow rate Peak expiratory flow rate is a measure of the velocity of air expelled from the respiratory apparatus during cough. Measured in liters/second.|1 hour||||Liters/second||Standard Deviation|Mean
2630416|NCT01854268|Primary|Lung Volume Initiation|Respiratory kinematic measure: lung volume initiation (LVI) Lung volume initiation is a measure of the volume of air in the lungs prior to a respiratory task.|1 hour|25 healthy young volunteers participated in this study. The average age was 23 years and none had a history of respiratory or neurological disease.|||% Vital Capacity, relative to EEL||Standard Deviation|Mean
2630417|NCT01854242|Primary|Serologic, Genetic and Inflammatory Markers Consistent With Inflammatory Bowel Disease|Participants who tested positive for Crohn disease, ulcerative colitis, or unspecified inflammatory bowel disease (IBD) on a panel for IBD are reported in the Outcome Measure Data Table.|2 weeks||||participants testing positive|||Number
2630418|NCT01854177|Primary|Intensity of Breathlessness|Intensity of Breathlessness was recorded on a visual analog scale. The scale range is 0-10 where 0 = minimum and 10 = maximal intensity. At each visit, participants were asked to report unpleasantness at 1 minute intervals. The measures were collected up to 20 minutes per visit and combined for a final score. Total minimum score = 0, total maximum score 200. Data is collected during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7) during which either Placebo or Aprepitant was administered.|Visit 2 (Approximately Day 3 where either Placebo or Aprepitant was administered).and Visit 3 (approximately Day 6 where either Placebo or Aprepitant was administered)||||units on a scale||Standard Deviation|Mean
2630419|NCT01854177|Primary|Unpleasantness of Breathlessness|Unpleasantness of breathlessness was reported each minute by the patient on a visual analog scale. The scale range is 0-10 where 0 = No breathlessness and 10 = Severe breathlessness. The measures were collected up to 20 minutes per visit and combined for a final score. Total minimum score = 0, total maximum score 200. Data is collected during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7) during which either Placebo or Aprepitant was administered. A high unpleasantness indicates that breathing difficulty feels very bad or terrifying regardless of whether the intensity is high or low|Visit 2 (Approximately Day 3 where either Placebo or Aprepitant was administered).and Visit 3 (approximately Day 6 where either Placebo or Aprepitant was administered)|One patient was excluded from analysis because there was a 28% difference in her post-bronchodilator FEV1 between visits 2 and 3.|||units on a scale||Standard Deviation|Mean
2630420|NCT01854138|Secondary|Number of Participants With Hematoma||60 days||||Participants|||Count of Participants
2630421|NCT01854138|Secondary|Number of Participants With Seroma||60 days||||Participants|||Count of Participants
2630424|NCT01854047|Post-Hoc|Change From Baseline in FEV1 at Week 12: Subset of ITT Population With Baseline Blood Eosinophil <0.3 G/L|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|Analysis was performed on subset of ITT population which included participants with baseline blood eosinophil count <0.3 G/L.|||liter||Standard Deviation|Mean
2630425|NCT01854047|Secondary|Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: ITT Population|Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study. The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded by the participants in their electronic diary.|Baseline, Week 12|ITT population.|||inhalations per day||Standard Deviation|Mean
2630426|NCT01854047|Secondary|Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: HEos-ITT Population|Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study. The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded by the participants in their electronic diary.|Baseline, Week 12|HEos-ITT Population.|||inhalations per day||Standard Deviation|Mean
2630427|NCT01854047|Secondary|Change From Baseline in AQLQ Global Score at Week 12: ITT Population|The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point Likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.|Baseline, Week 12|ITT population.|||scores on a scale||Standard Deviation|Mean
2630428|NCT01854047|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12: HEos-ITT Population|The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point Likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.|Baseline, Week 12|HEos-ITT population.|||scores on a scale||Standard Deviation|Mean
2630429|NCT01854047|Secondary|Change From Baseline in ACQ-5 Score at Week 12: ITT Population|The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.|Baseline, Week 12|ITT population.|||scores on a scale||Standard Deviation|Mean
2630430|NCT01854047|Secondary|Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 12: HEos-ITT Population|The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.|Baseline, Week 12|HEos-ITT population.|||scores on a scale||Standard Deviation|Mean
2630431|NCT01854047|Secondary|Change From Baseline in Evening Asthma Symptom Score at Week 12: ITT Population|Evening asthma symptom score was determined using PM symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.|Baseline, Week 12|ITT population.|||scores on a scale||Standard Deviation|Mean
2630432|NCT01854047|Secondary|Change From Baseline in Evening Asthma Symptom Score at Week 12: HEos-ITT Population|Evening asthma symptom score was determined using PM (post meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.|Baseline, Week 12|HEos ITT population.|||scores on a scale||Standard Deviation|Mean
2630433|NCT01854047|Secondary|Change From Baseline in Morning Asthma Symptom Score at Week 12: ITT Population|Morning asthma symptom score was determined using AM symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night. It ranged from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night-time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.|Baseline, Week 12|ITT population.|||scores on a scale||Standard Deviation|Mean
2630434|NCT01854047|Secondary|Change From Baseline in Morning Asthma Symptom Score at Week 12: HEos-ITT Population|Morning asthma symptom score was determined using AM (ante meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night. It ranged from 0 to 4 as: 0 = No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night-time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.|Baseline, Week 12|HEos-ITT population.|||scores on a scale||Standard Deviation|Mean
2630435|NCT01854047|Secondary|Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: ITT Population|The time to first LOAC event was defined as the time from the date of first dose to the date of the first LOAC event. For participants who had no LOAC event on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first LOAC was not estimated because the number of LOAC was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of LOAC at Week 12 and 24, are presented as the descriptive measure statistics.|Baseline up to Week 24|ITT population. Here 'overall number of participants analyzed' signifies participants of the ITT population who were treated.|||probability of LOAC||95% Confidence Interval|Number
2630436|NCT01854047|Secondary|Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: HEos-ITT Population|The time to first LOAC event was defined as the time from the date of first dose to the date of the first LOAC event. For participants who had no LOAC event on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first LOAC was not estimated because the number of LOAC was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of LOAC at Week 12 and 24, are presented as the descriptive measure statistics.|Baseline up to Week 24|HEos-ITT population. Here ‘overall number of participants analyzed’ signifies participants of the HEos-ITT population who were treated.|||probability of LOAC||95% Confidence Interval|Number
2630437|NCT01854047|Secondary|Annualized Event Rate of LOAC During The Treatment Period: ITT Population|LOAC was defined as any of the following: >=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS >=4 times the dose at randomization; use of systemic corticosteroids for >=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 24|ITT population. Here 'overall number of participants analyzed' signifies participants of the ITT population who were treated.|||LOAC per participant-year||95% Confidence Interval|Number
2630438|NCT01854047|Secondary|Annualized Event Rate of Loss of Asthma Control (LOAC) During The Treatment Period: HEos-ITT Population|LOAC was defined as any of the following: >=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in inhaled corticosteroid (ICS) >=4 times the dose at randomization; use of systemic corticosteroids for >=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 24|HEos-ITT population. Here ‘overall number of participants analyzed’ signifies participants of the HEos-ITT population who were treated.|||LOAC per participant-year||95% Confidence Interval|Number
2630439|NCT01854047|Secondary|Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: ITT Population|The time to first severe exacerbation was defined as the time from the date of first dose to the date of the first severe exacerbation event. For participants who had no severe exacerbation on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first severe exacerbation was not estimated because the number of severe exacerbations was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of severe exacerbation at Week 12 and 24, are presented as the descriptive measure statistics.|Baseline up to Week 24|ITT population. Here 'overall number of participants analyzed' signifies participants of ITT population who were treated.|||probability of Severe Exacerbation||95% Confidence Interval|Number
2630440|NCT01854047|Secondary|Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: HEos-ITT Population|The time to first severe exacerbation was defined as the time from the date of first dose to the date of the first severe exacerbation event. For participants who had no severe exacerbation on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first severe exacerbation was not estimated because the number of severe exacerbations was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of severe exacerbation at Week 12 and 24, are presented as the descriptive measure statistics.|Baseline up to Week 24|HEos-ITT population. Here ‘overall number of participants analyzed’ signifies participants of the HEos-ITT population who were treated.|||probability of Severe Exacerbation||95% Confidence Interval|Number
2630441|NCT01854047|Secondary|Annualized Event Rate of Severe Exacerbation During The Treatment Period: ITT Population|A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 24|ITT population. Here 'overall number of participants analyzed' signifies participants of the ITT population who were treated.|||exacerbation per participant-year||95% Confidence Interval|Number
2630442|NCT01854047|Secondary|Annualized Event Rate of Severe Exacerbation During The Treatment Period: HEos-ITT Population|A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for >=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.|Baseline to Week 24|HEos-ITT population. Here ‘overall number of participants analyzed’ signifies participants of the HEos-ITT population who were treated.|||exacerbation per participant-year||95% Confidence Interval|Number
2630443|NCT01854047|Secondary|Percent Change From Baseline in FEV1 at Week 12: ITT Population|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|ITT population. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure.|||percent change||Standard Deviation|Mean
2630444|NCT01854047|Secondary|Percent Change From Baseline in FEV1 at Week 12: HEos-ITT Population|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|HEos-ITT population. Here 'overall number of participants analyzed' signifies participants with available data for this outcome measure.|||percent change||Standard Deviation|Mean
2633195|NCT01828112|Secondary|Overall Survival (OS)|OS is defined as time from date of randomization to date of death due to any cause.|Month 18||2023-07-31|07/2023||||
2630446|NCT01854047|Primary|Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population|FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.|Baseline, Week 12|HEos-ITT population: subset of intent to treat (ITT) population (defined as randomized population analyzed according to the treatment group allocated by randomization, regardless of whether the treatment was actually received) which included participants with baseline blood eosinophils >=0.3 G/L.|||liter||Standard Deviation|Mean
2630447|NCT01854034|Secondary|Exon 20 EGFR Mutations Among Participants That Responded to Treatment|"The specific exon 20 epidermal growth factor receptor (EGFR) mutations among participants that achieved either a partial response or complete response as assessed by RECIST. The EGFR mutations were assessed from biopsies taken at baseline and then the baseline mutations were categorized by disease response.~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|Baseline, at the time of response||||participants|||Number
2630448|NCT01854034|Secondary|The Number of Participants With Treatment Related Serious Adverse Events|The number of participants with serious adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) that were deemed to be possibly, probably, or definitely related to study treatment as determined by the treating physician.|From the start of treatment until 28 days after the end of treatment||||Participants|||Count of Participants
2630449|NCT01854034|Secondary|Median Progression Free and Overall Survival|Overall survival (OS) is measured from the start of treatment until the time of death. Progression free survival is measured from the start of treatment until the time of death or disease progression as assessed by RECIST. Progressive disease is defined as having at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions denotes disease progression.|From the start of treatment until the time or death or disease progression||||Months||95% Confidence Interval|Median
2630450|NCT01854034|Primary|Overall Response Rate|"The number of participants that achieved a response to treatment as assessed by Response Evaluation Criteria is Solid Tumors (RECIST). Response is defined as having achieved either a complete response (CR) or a partial response (PR).~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|From the start of treatment until the time of disease progression, median duration of follow-up of about 3 months||||Participants|||Count of Participants
2630451|NCT01853982|Primary|Clinical Response at the End of Therapy Visit||24 hours after last dose of study drug|There is no analysis population or data available for this measure. This study was electively terminated to focus on a larger registrational study, which was also part of the clinical development program for nosocomial pneumonia.||||||
2630452|NCT01853930|Primary|Change in Reading Performance and Accuracy Using MNREAD.|Participants will be trained to use eccentric viewing for reading. They will then be assessed on the following outcome measures; reading, speed and accuracy using the MNRead test, binocular visual acuity and contrast sensitivity.|Participants will be assessed at baseline, 1 month and 2 months but change between baseline and final (2 months) will be reported|All 33 participants who received and completed training on the PAECT platform for eight weeks (in the laboratory or at-home) were included in the analysis.|||Words Per Minuted (WPM)||Standard Deviation|Mean
2630453|NCT01853878|Secondary|Number of Subjects With Any Adverse Events (AEs) by Intensity Grade.|Grading was done as per the Common Terminology Criteria for Adverse Events (CTCAE) of the U.S. National Cancer Institute, version 4.0. The intensity grades assessed were: 1, 2, 3, 4, 5 and Unknown.|From Week 0 to Week 112|This analysis was performed on the Total Treated population, which included all the patients who had received at least one dose of the study product.|||Participants|||Count of Participants
2630454|NCT01853878|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. An event that was part of the natural course of the disease under study (i.e., disease progression, recurrence) was captured in the study as an efficacy measure; therefore it did not need to be reported as an SAE.|During the entire study (From Week 1 to Week 112)|This analysis was performed on the Total Treated population, which included all the patients who had received at least one dose of the study product.|||Participants|||Count of Participants
2630455|NCT01853878|Secondary|Number of Subjects With Any Abnormal Hematological and Biochemical Parameters|Hematological and biochemical parameters assessed were tabulated by maximum grade versus baseline, by CTCAE = Common Terminology Criteria for Adverse Events version 4.0 (Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening; Grade 5 = death; Grade Unknown) and by the type of abnormality (e.g. increased, decreased, prolonged, etc.). Some parameters (e.g. Anemia) already comprise within their definition the type of abnormality presented.|During the entire study period (From Week 1 to Week 112)|This analysis was performed on the Total Treated population, which included all the patients who had received at least one dose of the study product and for whom blood results were available for the respective parameter assessed.|||Participants|||Count of Participants
2630456|NCT01853878|Secondary|Anti-PRAME Antibody Concentrations|Considering that two Phase III studies with recMAGE-A3 + AS15 failed to demonstrate clinical efficacy of the MAGE-A3 antigen specific cancer immunotherapeutic, GSK decided to stop the development of all recombinant protein based cancer vaccines and to stop recruitment in all the ongoing clinical studies. Therefore, based on scientific and medical relevance, the decision was made to stop patient enrollment in the PRAME-AS15-NSC-002 (ADJ) clinical study and to stop follow-up visits, further sample collection for research purposes and the analysis of samples for research purposes. In consequence, the primary and secondary outcomes were not analysed as planned and clinical data for this outcome was not collected.|At each defined time point from Week 0 till Concluding Visit (Week 112)|Anti-PRAME antibody data was not collected.||||||
2630466|NCT01853839|Secondary|The Difference in Systolic Blood Pressure Before and After the Month of Ramadan|Change from baseline in systolic blood pressure before and after the month of Ramadan|Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks|Per-protocol population|||mmHg||Standard Deviation|Mean
2630457|NCT01853878|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|Unsolicited AEs covered any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 31-day (Days 0-30) post-vaccine administration period|This analysis was performed on the Total Treated population, which included all the patients who had received at least one dose of the study product.|||Participants|||Count of Participants
2630458|NCT01853878|Secondary|DFS (Disease-free Survival) at 2, 3, 4 and 5 Years After Randomization|Defined as the time from randomization to either the date of first recurrence of the disease or the date of death (whatever the cause), whichever occurred first. The 5-year active follow-up period planned in the initial study protocol was cancelled per Protocol Amendment 2, hence this analysis was not performed.|During the entire follow-up period (From year 2 to Year 5)|The 5-Year Follow-Up Disease Free Survival data were not collected.||||||
2630459|NCT01853878|Secondary|Disease-free Specific Survival (DFSS)|DFSS was defined as the interval from randomization to the date of first recurrence of disease or date of death due to lung cancer, whichever occurs first. Patients without recurrence or death due to lung cancer were censored at the date of last assessment. Considering that two Phase III studies with recMAGE-A3 + AS15 failed to demonstrate clinical efficacy of the MAGE-A3 antigen specific cancer immunotherapeutic, GSK decided to stop the development of all recombinant protein based cancer vaccines and to stop recruitment in all the ongoing clinical studies. Therefore, based on scientific and medical relevance, the decision was made to stop patient enrollment in the PRAME-AS15-NSC-002 (ADJ) clinical study and to stop follow-up visits, further sample collection for research purposes and the analysis of samples for research purposes. In consequence, the primary and secondary outcomes were not analysed as planned and clinical data for this outcome was not collected.|During the entire study (From Week 1 to Week 112)|Disease free-specific survival data was not collected.||||||
2630460|NCT01853878|Secondary|Lung-cancer-specific Survival|Lung-cancer specific survival was defined as defined as the interval from randomization to the date of death due to lung cancer; deaths due to other or unknown causes were censored at the date of death. Considering that two Phase III studies with recMAGE-A3 + AS15 failed to demonstrate clinical efficacy of the MAGE-A3 antigen specific cancer immunotherapeutic, GSK decided to stop the development of all recombinant protein based cancer vaccines and to stop recruitment in all the ongoing clinical studies. Therefore, based on scientific and medical relevance, the decision was made to stop patient enrollment in the PRAME-AS15-NSC-002 (ADJ) clinical study and to stop follow-up visits, further sample collection for research purposes and the analysis of samples for research purposes. In consequence, the primary and secondary outcomes were not analysed as planned and clinical data for this outcome was not collected.|During the entire study (From Week 1 to Week 112)|Lung-cancer specific survival data was not collected.||||||
2630461|NCT01853878|Secondary|Overall Survival (OS)|OS was defined as the interval from randomization to the date of death, irrespective of the cause of death; patients still alive were censored at the last visit they are known to be alive. Considering that two Phase III studies with recMAGE-A3 + AS15 failed to demonstrate clinical efficacy of the MAGE-A3 antigen specific cancer immunotherapeutic, GSK decided to stop the development of all recombinant protein based cancer vaccines and to stop recruitment in all the ongoing clinical studies. Therefore, based on scientific and medical relevance, the decision was made to stop patient enrollment in the PRAME-AS15-NSC-002 (ADJ) clinical study and to stop follow-up visits, further sample collection for research purposes and the analysis of samples for research purposes. In consequence, the primary and secondary outcomes were not analysed as planned and clinical data for this outcome was not collected.|During the entire study (From Week 1 to Week 112)|Overall survival data was not collected.||||||
2630462|NCT01853878|Primary|Time to Occurrence of Any Recurrence of Disease|Time to occurrence of any recurrence of disease was expressed in terms of rate: Person-year rate in each group = number of patients reporting at least one recurrence of disease (n)/ sum of follow-up period expressed in years (T[year)]) As a consequence of the decision to stop the PRAME-AS15-NSC-002 (ADJ) study, not all data were available for a full analysis. The median follow-up time was 10.3 months in the GSK2302032A group and 5.7 months in the Placebo group. Considering that two Phase III studies with recMAGE-A3 + AS15 failed to demonstrate clinical efficacy of the MAGE-A3 antigen specific cancer immunotherapeutic, GSK decided to stop the development of all recombinant protein based cancer vaccines and to stop recruitment in all the ongoing clinical studies.|During the entire study (From Week 1 to Week 112)|The analysis was performed on the Total Treated population that included all the subjects who had received at least one dose of the study product.|||person-year rate|||Number
2630463|NCT01853839|Secondary|Adverse Events Under Angiotensin II (Type 1) Receptor Blockers (ARBs) Treatment When Given in Combination With Calcium-Channel Blockers (CCBs)|Number of participants with adverse events in participants receiving Angiotensin II (Type 1) Receptor Blockers (ARBs) when given in combination with Calcium-Channel Blockers (CCBs) during the whole study duration.|Up to 52 weeks|All subjects who took a combination of ARB and CCB drugs.|||participants|||Number
2630464|NCT01853839|Secondary|The Percentage of Patients Achieving JNC 7 Treatment Goals at the End of the 1 Year Treatment Duration|The proportion of patients enrolled in the study who achieve the JNC 7 (the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) treatment goals (blood pressure (BP) <140/90 mmHg) in a primary-care setting at the end of the 1 year treatment duration. This variable was derived from the mean sitting blood pressure assessed by the investigators at the end of the 1 year treatment duration. To achieve JNC 7 treatment goals, the subject had to satisfy both blood pressure criteria - systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg. At this timepoint, a diagnosis of diabetes mellitus and/or kidney disease was also taken into account. Subjects with either of the mentioned conditions had to have systolic blood pressure lower than 130 mm Hg and diastolic blood pressure below 80 mm Hg to satisfy JNC 7 treatment goals.|Up to 52 weeks|Per-protocol population|||Percentage of participants|||Number
2630465|NCT01853839|Secondary|The Difference in Diastolic Blood Pressure Before and After the Month of Ramadan|Change from baseline in diastolic blood pressure before and after the month of Ramadan|Baseline, 10 days before Ramadan, 10 days after Ramadan and 52 weeks|Per-protocol population|||mmHg||Standard Deviation|Mean
2630467|NCT01853839|Secondary|Achievement of the JNC 7 Treatment Goals During the Whole Study Duration (Treated by Internists and Cardiologists as Primary Physician)|Proportion of patients who achieved the JNC 7 treatment goals during the whole study duration (treated by internists and cardiologists as primary physician)|Up to 52 weeks|Per-protocol population|||Percentage of participants|||Number
2630468|NCT01853839|Secondary|Compliance of Patients During the Whole Study Duration (52 Weeks)|"Compliance of patients during the whole study duration (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from none of the time to all of the time."|Up to 52 weeks|Per-protocol population including all patients with data at 52 weeks|||Percentage of participants|||Number
2630469|NCT01853839|Secondary|Compliance of Patients up to 10 Days After Ramadan|"Compliance of patients up to 10 days after Ramadan (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from none of the time to all of the time."|10 days after Ramadan|Per-protocol population including all patients with data 10 days after Ramadan|||Percentage of participants|||Number
2630470|NCT01853839|Secondary|Compliance of Patients up to 10 Days Before Ramadan|"Compliance of patients up to 10 days before ramadan (treated by internists and cardiologists as primary physician). Subjects were asked how often they have not taken their medicine and were given five possible choices from none of the time to all of the time."|10 days before Ramadan|Per-protocol population including all patients with data 10 days before Ramadan|||Percentage of participants|||Number
2630471|NCT01853839|Secondary|The Overall Assessment of Treatment by Physicians at 52 Weeks|The overall assessment of treatment by physicians at 52 weeks. Assessed using a verbal rating scale with 5 categories: Outstanding, very satisfactory, satisfactory, marginal and not satisfactory.|Up to 52 weeks|Per-protocol population|||Percentage of participants|||Number
2630472|NCT01853839|Secondary|The Overall Assessment of Treatment by Patients at 52 Weeks|The overall assessment of treatment by patients at 52 weeks. Assessed using a verbal rating scale with 5 categories: Outstanding, very satisfactory, satisfactory, marginal and not satisfactory.|Up to 52 weeks|Per-protocol population|||Percentage of participants|||Number
2630473|NCT01853839|Secondary|Cardiovascular Events|Percentage of participants who experienced a major cardiovascular (CV) event|Up to 52 weeks|All subjects included in the study according to the study protocol i.e. patients who did not violate any inclusion or exclusion criteria|||Percentage of participants|||Number
2630474|NCT01853839|Secondary|Achieving JNC 7 Treatment Goals After Ramadan|The proportion of patients enrolled in the study who achieve the JNC 7 (the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) treatment goals (blood pressure (BP) <140/90 mmHg) in a primary-care setting after Ramadan. This variable was derived from the mean sitting blood pressure assessed by the investigators after Ramadan. To achieve JNC 7 treatment goals, the subject had to satisfy both blood pressure criteria - systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg.|1 month|Per-protocol (PP) population which included all eligible patients who did not experience any protocol violation and were treated with the study medication up to week 52 (study completers) according to the prescribing information.|||Percentage of participants|||Number
2630475|NCT01853839|Primary|Achievement of the JNC 7 Treatment Goals (BP <140/90 mmHg) at Week 52|The proportion of patients enrolled in the study who achieve the JNC 7 (the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure) treatment goals (blood pressure (BP) <140/90 mmHg) in a primary-care setting at week 52. This variable was derived from the mean sitting blood pressure assessed by the investigators at week 52. To achieve JNC 7 treatment goals, the subject had to satisfy both blood pressure criteria - systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg.|Up to 52 weeks|ITT dataset which included all patients, who received at least one dose of study medication.|||Percentage of participants|||Number
2630476|NCT01853774|Secondary|The Secondary Outcome is Participant Completion of a CRC Screening Test.|Individuals receiving group classes and tailored navigation during Phase I will have higher rates of CRC screening test completion than those receiving classes only, (however this outcome will be primarily due to clinic attendance).|At 3- and 6-months post clinic visit, we will collect screening data from patient self-report and medical chart reviews.||||Participants|||Count of Participants
2630477|NCT01853774|Primary|Primary Outcome is Clinic Attendance|Track outcomes of the Phase I intervention on colorectal cancer (CRC) screening test completion among low-income, multicultural Arizona residents aged 50 to 75 years who attend clinic.|Attendance at the community educational class and 8 weeks beyond to attendance at a clinic.||||Participants|||Count of Participants
2630478|NCT01853696|Secondary|Immunologic Graft Rejection Episode|Rejection episodes were assessed by slit lamp examination and categorized as definite when an endothelial rejection line was detected in a previously clear graft, probable when inflammation (stromal infiltrate, keratic precipitates, cells in the anterior chamber, or ciliary injection) was detected in a previously clear graft without an endothelial rejection line, and possible if central corneal pachymetry increased by 30 microns or more, even if the cornea was clear and no inflammation was detected by slit lamp examination.|within first year after cornea transplantation||||eyes|Participants||Number
2630479|NCT01853696|Primary|Intraocular Pressure|Number of eyes in which the absolute intraocular pressure equaled or exceeded 24 mm Hg OR in which there was a relative increase of at least 10 mm Hg over the baseline preoperative reading.|from 1 to 12 months after transplant||||eyes|Participants||Number
2630480|NCT01853644|Post-Hoc|6 Month Progression Free Survival Rate|PFS rate will be measured by the number of patients that are progression free at 6 months from treatment initiation.|6 months from start of treatment||||participants|||Number
2630492|NCT01853605|Primary|Investigator Satisfaction With Breast Implants on a 5-Point Scale|Investigator satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for Investigator's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the Investigator reports different responses for the left and right breasts.|5 years|Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants, who completed the 5 year follow-up visit, and had data at the time point.|||Subjects|||Number
2630481|NCT01853644|Post-Hoc|Clinical Benefit Rate (CBR)|"CBR is defined as the percentage of patients with Complete Response (CR) plus those with Partial Response (PR) plus those with Stable Disease (SD) as assessed by RECIST 1.1 where:~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note:the appearance of one or more new lesions is also considered progressions).~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|Time taken to reach first best response. Range 1-4 cycles (1 cycle = 28 days)|3 patients who were determined to be not evaluable are included in this number|||participants|||Number
2630482|NCT01853644|Post-Hoc|Overall Best Response of Patients With Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib|"Overall Best Response as measured by physical exam findings, serum CA125 levels and/or measurement of index lesions via appropriate imaging studies using RECIST criteria defined as either:~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note:the appearance of one or more new lesions is also considered progressions).~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|Time taken to reach first best response. Range 1-4 cycles (1 cycle = 28 days)||||Participants|||Count of Participants
2630483|NCT01853644|Secondary|Overall Survival (OS) in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib|OS is defined from the start of treatment until date of death from any cause or date of last contact.|Range of months 1-39||||months||Full Range|Median
2630484|NCT01853644|Secondary|Number of Adverse Events in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib|Adverse events will be assessed by NCI CTCAE v 4.03. Adverse event that were determined to be serious adverse events (either grade 3, 4, or 5) related to study drug were collected. Grading is as follows:|During treatment and up to 30 days after completion of study treatment. Range of cycles 1-31 (1 cycle =28 days).|||||||
2630485|NCT01853644|Secondary|Progression Free Survival (PFS) in Platinum-resistant Ovarian Cancer to Treatment With Single Agent Tivozanib|The Kaplan-Meier method will be utilized to estimate the median and overall distribution of PFS and will be defined from the start of treatment until the first documentation of progressive disease or death, whichever occurs first..|Range of months 1-25||||months||Full Range|Median
2630486|NCT01853644|Primary|Overall Response Rate (ORR)|"ORR is defined as the percentage of patients with complete response plus those with partial response as measured by RECIST 1.1 where:~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|Time taken to reach first best response. Range 1-4 cycles (1 cycle = 28 days)||||participants|||Number
2630487|NCT01853618|Secondary|Overall Survival|Overall survival is defined as the amount of time a subject survives after therapy.|From the time of initial treatment consent until date of death for each patient. Overall survival ranged from 6 months to 13.1 months.||||Months||95% Confidence Interval|Median
2630488|NCT01853618|Secondary|Progression Free Survival (PFS)|Progression free survival is defined as the amount of time a subject survives without disease progression after treatment. Progression is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if it is the smallest on study). The appearance of one or more lesions is also considered progressions.|Progression free survival is time patients were off treatment until death. For all cohorts progression free survival ranged from 3.4 months to 8.6 months||||Months||95% Confidence Interval|Median
2630489|NCT01853618|Secondary|Number of Participants With Best Response|Best response was assessed by the combined Response Evaluation Criteria in Solid Tumors (RECIST and the Modified Immune-Related Response Criteria (irRC). Complete Response (CR) is disappearance of all target lesions. Any patjhological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if it is the smallest on study). The appearance of one or more lesions is also considered progressions.|Start of study, baseline target lesions until disease progression occurs with 20% increase of target lesions or appearance of new lesions, up to 13.1 months||||Participants|||Count of Participants
2630490|NCT01853618|Primary|Number of Participants With Serious and Non-Serious Adverse Events Regardless of Attribution|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 44 months and 5 days for 1/Arm A1; 49 months and 26 days for 2/Arm A2; 1 month and 26 days for 3/Arm B; 30 months and 20 days for 5/Arm D; and 34 months and 25 days for 6/Arm E.||||Participants|||Count of Participants
2630491|NCT01853605|Primary|Local Complications|Local complications are the cumulative complications occurring in at least 5% of subjects in 1 or more cohorts over the duration of the study. The Kaplan-Meier risk rate is presented.|5 years|Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants who completed the 5 year follow-up visit.|||Percentage of Subjects||95% Confidence Interval|Number
2630493|NCT01853605|Primary|Subject Satisfaction With Breast Implants on a 5-Point Scale|Subject satisfaction with each breast implant is assessed on the following 5-point scale: (Definitely Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, and Definitely Dissatisfied). Satisfaction is reported for subject's assessing satisfaction as definitely satisfied and somewhat satisfied. The worst response is used if the subject reports different responses for the left and right breasts.|5 years|Evaluable population: all enrolled subjects implanted with the NATRELLE 410 original style implants, who completed the 5 year follow-up visit, and had data at the time point.|||Subjects|||Number
2630494|NCT01853553|Other Pre-specified|Change in Circulating Markers of Oxidative Stress at 6 Months.|All markers of oxidative stress will be assayed by multiplexed validated liquid chromatography (LC)/ LC-mass spectrometry (MS)/ MS.|Baseline and 6 months.|||||||
2630495|NCT01853553|Secondary|Change From Baseline in Vascular Stiffness at 6 Months.|Aortic pulse wave velocity, a measure of large elastic arterial stiffness, and carotid compliance, a measure of large artery distensibility, will be determined. A transcutaneous custom tonometers (Noninvasive Hemodynamics Workstation, Cardiovascular Engineering Inc., Norwood, MA) will be positioned at the aorta and femoral artery to measure pulse wave velocity, and carotid artery compliance (and the β-stiffness index, a more blood pressure independent measure of local arterial stiffness) will be measured non-invasively using simultaneous high-resolution ultrasonography and applanation tonometry). Higher values correspond to greater stiffness.|Baseline and 6 months||||m/s||Standard Deviation|Median
2630496|NCT01853553|Primary|Change From Baseline in Flow Mediated Dilation at 6 Months.|FMD will be determined using high-resolution ultrasonography|Baseline and 6 months.||||Percent change.||Standard Deviation|Mean
2630497|NCT01853475|Secondary|Piperaquine AUC0-inf|Area under the Piperaquine plasma concentration time curve from time zero to time infinity using observed values.|Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43|Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2630498|NCT01853475|Secondary|Piperaquine Cmax|Piperaquine maximum concentration observed|Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43|Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2630499|NCT01853475|Primary|OZ439 AUC0-inf|Area under the OZ439 plasma concentration time curve from time zero to time infinity using observed values.|Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43|Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2630500|NCT01853475|Primary|OZ439 Cmax|OZ439 maximum concentration observed|Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43|Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2630501|NCT01853462|Secondary|Participants With Recurrent Ankle Sprain||Twelve months after the completion of training||||Participants|||Count of Participants
2630502|NCT01853462|Secondary|Electromyographic Activity of Tibialis Anterior Muscle During Foot Inversion at 120°/Sec Speed|Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the foot invertor muscles, at 120°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the anterior tibialis muscle was used as the reference value for normalization.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Proportion||Standard Deviation|Mean
2630503|NCT01853462|Secondary|Electromyographic Activity of Tibialis Anterior Muscle During Foot Inversion at 30°/Sec Speed|Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the foot invertor muscles, at 30°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the anterior tibialis muscle was used as the reference value for normalization.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Proportion||Standard Deviation|Mean
2630504|NCT01853462|Secondary|Electromyographic Activity of Peroneus Longus Muscle During Foot Eversion at 120°/Sec Speed|Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the foot evertor muscles, at 120°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the peroneus longus muscle was used as the reference value for normalization.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Proportion||Standard Deviation|Mean
2630505|NCT01853462|Secondary|Electromyographic Activity of Peroneus Longus Muscle During Foot Eversion at 30°/Sec Speed|Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the foot evertor muscles, at 30°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the peroneus longus muscle was used as the reference value for normalization.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Proportion||Standard Deviation|Mean
2630780|NCT01850446|Secondary|Dynamics of Parameters of Immune Status (T-cell and B-cell Immune Response).|The concentration of regulators of the T-cell immune response (IL2, IFN -γ, IL-18), and regulators of В-cell immune response (IL-4, IL-16).|On days1, 3 and 7 of observation.|Intention to treat [ITT]|||pg/mL||Standard Deviation|Mean
2630506|NCT01853462|Secondary|Electromyographic Activity of Peroneus Longus Muscle During Ankle Plantar Flexion at 120°/Sec Speed|Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the ankle plantar flexor muscles, at 120°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the peroneus longus muscle was used as the reference value for normalization.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Proportion||Standard Deviation|Mean
2630507|NCT01853462|Secondary|Electromyographic Activity of Peroneus Longus Muscle During Ankle Plantar Flexion at 30°/Sec Speed|Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the ankle plantar flexor muscles, at 30°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the peroneus longus muscle was used as the reference value for normalization.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Proportion||Standard Deviation|Mean
2630508|NCT01853462|Secondary|Electromyographic Activity of Anterior Tibialis Muscle During Ankle Dorsiflexion at 120°/Sec Speed|Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the ankle dorsiflexor muscles, at 120°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the anterior tibialis muscle was used as the reference value for normalization.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Proportion||Standard Deviation|Mean
2630509|NCT01853462|Secondary|Electromyographic Activity of Anterior Tibialis Muscle During Ankle Dorsiflexion at 30°/Sec Speed|Two surface electrodes and a ground electrode were used for assessment. Measurements were taken for the sprained leg, during isokinetic testing of the ankle dorsiflexor muscles, at 30°/sec speed, with the Biodex dynamometer. Normalized values of the electromyographic (EMG) signals were used for analysis, and EMG activity during maximal voluntary isometric contraction of the anterior tibialis muscle was used as the reference value for normalization.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Proportion||Standard Deviation|Mean
2630510|NCT01853462|Secondary|Peak Torque of Foot Invertor Muscles at 120°/Sec Speed|The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the subtalar joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Newton metres||Standard Deviation|Mean
2630511|NCT01853462|Secondary|Peak Torque of Foot Invertor Muscles at 30°/Sec Speed|The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the subtalar joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Newton metres||Standard Deviation|Mean
2630512|NCT01853462|Secondary|Peak Torque of Foot Evertor Muscles at 120°/Sec Speed|The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the subtalar joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Newton metres||Standard Deviation|Mean
2630513|NCT01853462|Secondary|Peak Torque of Foot Evertor Muscles at 30°/Sec Speed|The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the subtalar joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Newton metres||Standard Deviation|Mean
2630514|NCT01853462|Secondary|Peak Torque of Ankle Plantar Flexor Muscles at 120°/Sec Speed|The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the ankle joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Newton metres||Standard Deviation|Mean
2630515|NCT01853462|Secondary|Peak Torque of Ankle Plantar Flexor Muscles at 30°/Sec Speed|The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the ankle joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Newton metres||Standard Deviation|Mean
2630516|NCT01853462|Secondary|Peak Torque of Ankle Dorsiflexor Muscles at 120°/Sec Speed|The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the ankle joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Newton metres||Standard Deviation|Mean
2630517|NCT01853462|Secondary|Peak Torque of Ankle Dorsiflexor Muscles at 30°/Sec Speed|The Biodex isokinetic dynamometer was used for assessment. During isokinetic testing of the ankle joint, participants were in the seated position, with footwear on. Measurements were taken for the sprained leg, and the mean of five maximal trials was used for analysis.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Newton metres||Standard Deviation|Mean
2630531|NCT01853462|Primary|Ankle Functional Stability, Via the Single-leg Hop for Distance Test|Participants hopped, using the sprained leg, as far forward as possible, and remained in the landing position for 2sec. Three trials were performed, and the mean hopping distance was used for analysis.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Centimeters||Standard Deviation|Mean
2630518|NCT01853462|Secondary|Ankle Joint Sense for 30° Plantar Flexion|The Biodex isokinetic dynamometer was used for assessment. During testing, participants were blindfolded, in the seated position, with footwear on.The internal goniometer of Biodex recorded the degrees of error for the active repositioning of 30° plantar flexion (non-weight-bearing) for the sprained ankle, and the mean of three trials was used for analysis.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Degrees||Standard Deviation|Mean
2630519|NCT01853462|Secondary|Ankle Joint Sense for 15° Plantar Flexion|The Biodex isokinetic dynamometer was used for assessment. During testing, participants were blindfolded, in the seated position, with footwear on.The internal goniometer of Biodex recorded the degrees of error for the active repositioning of 15° plantar flexion (non-weight-bearing) for the sprained ankle, and the mean of three trials was used for analysis.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Degrees||Standard Deviation|Mean
2630520|NCT01853462|Secondary|Ankle Joint Sense for 10° Dorsiflexion|The Biodex isokinetic dynamometer was used for assessment. During testing, participants were blindfolded, in the seated position, with footwear on.The internal goniometer of Biodex recorded the degrees of error for the active repositioning of 10° dorsiflexion (non-weight-bearing) for the sprained ankle, and the mean of three trials was used for analysis.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Degrees||Standard Deviation|Mean
2630521|NCT01853462|Secondary|Present Pain|The third component of the Greek version of the short form of McGill Pain Questionnaire, which is a 6-point verbal rating scale, was used for the assessment. Participants noted what word at the time completing the questionnaire would best describe their pain sensation for the sprained ankle (scoring: no pain = 0, mild = 1, discomforting = 2, distressing = 3, horrible = 4, excruciating = 5). The score corresponding to the noted word was used for data analysis, with higher values representing a worse pain sensation.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Points on a scale||Full Range|Median
2630522|NCT01853462|Secondary|Pain Intensity During the Week Before Testing|The second component of the Greek version of the short form of McGill Pain Questionnaire, which is a visual analogue scale (VAS), was used for the assessment. The VAS is a horizontal 10-cm line with clearly defined boundaries: 0 cm = 'No pain' and 10.0 cm = 'worst possible pain'. partipants made a mark on the line at the point that better described the average pain intensity for their sprained ankle, during the week before testing. The distance marked from the 'no pain' point was measured in mm and was used for data analysis.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Points on a scale||Standard Deviation|Mean
2630523|NCT01853462|Secondary|Pain Sensation|The main component of the Greek version of the short form of McGill Pain Questionnaire (GR-SFMPQ) was used for the assessment of pain sensation of the sprained ankle. This consists of 15 descriptive adjectives for the pain sensation (11 sensory and 4 affective), which are self-rated according to their intensity level on a 4-point rating scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). The total rating score (minimum = 0, maximum = 45) of the main component of the GR-SFMPQ was used for data analysis, with higher values representing a worse pain sensation.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Total score of scales||Full Range|Median
2630524|NCT01853462|Secondary|Ankle Dorsiflexion Range of Motion|Assessement was performed with a goniometer. Participants actively dorsiflexed the sprained ankle, while being in long sitting, on a physical therapy table. The mean score of three measurements was used for analysis.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Degrees||Standard Deviation|Mean
2630525|NCT01853462|Secondary|Overall Stability Index|The Biodex Stability System, which is a dynamic tilting platform, was used for assessment. The overall stability index corresponded to the variance of foot platform overall displacement, and it was measured in single-leg stance, for the sprained leg, without footwear. Three 20-sec trials were performed, with open eyes, and the mean score was used for analysis.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Degrees||Standard Deviation|Mean
2630526|NCT01853462|Secondary|Medial-lateral Stability Index|The Biodex Stability System, which is a dynamic tilting platform, was used for assessment. The medial-lateral stability index corresponded to the variance of foot platform displacement in the frontal plane, and it was measured in single-leg stance, for the sprained leg, without footwear. Three 20-sec trials were performed, with open eyes, and the mean score was used for analysis.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Degrees||Standard Deviation|Mean
2630527|NCT01853462|Secondary|Anterior-posterior Stability Index|The Biodex Stability System, which is a dynamic tilting platform, was used for assessment. The anterior-posterior stability index corresponded to the variance of foot platform displacement in the sagittal plane, and it was measured in single-leg stance, for the sprained leg, without footwear. Three 20-sec trials were performed, with open eyes, and the mean score was used for analysis.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Degrees||Standard Deviation|Mean
2630528|NCT01853462|Primary|Endurance of Ankle Plantar Flexor Muscles|The rising on toes test was used, and participants rose on the toes of the sprained leg, as many times as possible. Scoring:10 points for >40 rises, 5 points for 30-39 rises, 0 points for <30 rises.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||points on a scale||Full Range|Median
2630529|NCT01853462|Primary|Endurance of Ankle Dorsiflexor Muscles|"The rising on heel test was used, and participants rose on the heel of the sprained leg, as many times as possible.~Scoring:10 points for >40 rises, 5 points for 30-39 rises, 0 points for <30 rises."|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||points on a scale||Full Range|Median
2630530|NCT01853462|Primary|Ankle Functional Stability, Via the Single-leg Hops for Time Test|Participants hopped, using the sprained leg, as fast as possible, a six-meter distance. Three trials were performed, and the mean hopping time was used for analysis.|Baseline, after the completion of training (follow-up 1), and eight weeks after the completion of training (follow-up 2)||||Seconds||Standard Deviation|Mean
2630532|NCT01853397|Secondary|Subject Satisfaction With Treatment|Subjects rated their satisfaction with treatment results using a 5-point Likert Satisfaction Scale (5: very satisfied; 4: satisfied; 3: neither satisfied nor dissatisfied; 2: dissatisfied; 1: very dissatisfied). The subject satisfaction score was analyzed as the proportion of subjects showing improvement as defined as a score of 4 or greater ('satisfied' or 'very satisfied').|4, 8, 12, and 16 weeks|Intent-to-treat|||percentage of subjects satisfied|||Number
2630533|NCT01853397|Secondary|Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)|Subjects self-assessed improvement in the treatment area and assigned a GAIS score at each visit. Scoring was based upon a five point grading System: 5 - Much Improved, 4 - Improved, 3 - No Change, 2 - Worse, or 1 - Much Worse. The definition of an improvement of the GAIS score included either a GAIS score of 'Improved' or 'Much Improved'.|4, 8, 12, and 16 weeks|Intent-to-treat|||percentage of subjects improved|||Number
2630534|NCT01853397|Secondary|Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)|"GAIS evaluations were performed by Investigators at the 4, 8, 12, and 16 week visits. Investigators used direct visual assessment (live assessment) compared to photographs of subjects taken before treatment (baseline) to assess improvement in the treatment area.~Scoring was based upon a five point grading System: 5 - Much Improved, 4 - Improved, 3 - No Change, 2 - Worse, or 1 - Much Worse. The definition of an improvement of the GAIS score included either a GAIS score of 'Improved' or 'Much Improved'."|4, 8, 12, and 16 weeks|Intent-to-treat|||Percentage of subjects improved|||Number
2630535|NCT01853397|Secondary|Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline|Change from baseline in waist circumference 4, 8, and 16 weeks after treatment was assessed by blinded evaluators.|4 weeks, 8 weeks, 16 weeks|Intent-to-treat|||cm||Standard Deviation|Mean
2630536|NCT01853397|Primary|Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline|Change from baseline in waist circumference 12 weeks after treatment was assessed by blinded evaluators.|12 weeks|Intent-to-treat|||cm||Standard Deviation|Mean
2630537|NCT01853384|Secondary|Change From Baseline in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks|Target leg pain were measured using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.|Baseline and Weekly, over the 12 week treatment period|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.|||mm||Standard Error|Least Squares Mean
2630538|NCT01853384|Secondary|Change From Baseline in Pain Associated With the Target Wound at Each of the 12 Double Blind Treatment Weeks|Target ulcer pain was measured using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.|Baseline and Weekly, over the 12 week treatment period|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.|||mm||Standard Error|Least Squares Mean
2630539|NCT01853384|Secondary|Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure|Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment.|Target ulcer status observed at two (visit 1) and three (visit 2) months following initial ulcer closure.|Due to study termination the data available to assess durability of closure were limited to only the subjects who completed at least one of the follow-up visits. Participants who had CLOSED wounds at completion of treatment; 103 subjects (HP802-247: 49; Vehicle: 54) completed Visit 18, 114 subjects (HP802-247: 57; Vehicle: 57) completed Visit 19|||participants|||Number
2630540|NCT01853384|Secondary|Compare the Treatment Groups for the Proportion of Subjects With Wound Closure at Each of the 12-Week Treatment Period From Baseline|For subjects who dropped from the study, their remaining visit values were imputed using LOCF. Treatment groups were compared for percentage of participants with closed wounds at each treatment visit.|Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first|ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test, adjusted for sites, with significance being at P < 0.05|||percentage of participants|||Number
2630541|NCT01853384|Secondary|Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Median Time (Days) to Closure Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was based on a Kaplan-Meier Survival analysis.|12 weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using Kaplan-Meier Survival analysis, with significance being at P < 0.05.|||days||95% Confidence Interval|Median
2630542|NCT01853384|Secondary|Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was based on a Cox Proportional Hazard Analysis.|12 Weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Cox Proportional hazard procedure, with significance being at P < 0.05.|||days||Full Range|Median
2630543|NCT01853384|Primary|Compare the Treatment Groups for the Number of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline|"For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed.~For subjects who dropped from the study prior to the end of treatment, their remaining visit values were imputed using LOCF; wound status of closed was not imputed."|Weekly, over 12 Weeks or until wound closure, which ever occurred first|ITT Populations: Subjects who received at least one dose of test article.|||participants|||Number
2630544|NCT01853371|Primary|Diastolic Blood Pressure After 4 Weeks||1 month||||mmHg||Standard Deviation|Mean
2630545|NCT01853371|Secondary|Incidence of Wet Cupping Side Effects in Intervention Group|"Immediate side effects of wet cupping will be assessed through a checklist on the after each cupping session.~Delayed side effects of wet cupping will be assessed through another checklist after 1 month of the final hijama session."|1 month|||||||
2630547|NCT01853332|Secondary|Health Risk Factors|"An index score of health behavior risk factors was created. Any amount of smoking, non-optimal drinking (≥ 7 drinks per week for women; ≥ 14 drinks per week for men), a score in the bottom tertile of the AHEI, and minimal exercise (< 6 metabolic hours per week) were considered risk factors, coded as 1, and then tallied. The range of scores for health risk factors in the current sample was between 0 and 4 health risk factors (where 4 is more risk factors)."|cross-sectional||||sum of health risk factors||Standard Deviation|Mean
2630548|NCT01853332|Secondary|Body Mass Index (BMI)|BMI is calculated as weight in kilograms divided by height in meters squared.|cross-sectional||||kg/m^2||Standard Deviation|Mean
2630549|NCT01853332|Primary|Social Adjustment Scale|The Social Adjustment Scale is a semi-structured interview assessing functioning in the preceding 2 months in domains of work (including employment functioning, homemaking and other household functions, and/or student/educational functioning), friendships/leisure, and relationships with extended family. If applicable, relationships with immediate family members (spouse/partner and/or children) are also assessed. The SAS is closely linked to mental health and can be used as a tool for assessing treatment response to psychotropic medications or therapies. Positive adjustment is the ability to carry out each activity/role effectively, deriving satisfaction/support from that domain, whereas poor adjustment reflects maladaptation, dissatisfaction, disengagement, and/or discord. Scores range from 1 (excellent adjustment) to 7 (very poor adjustment). Coding was completed during an audio-recorded interview; 12% were coded for agreement (91%).|2.5 years||||units on a scale||Standard Deviation|Mean
2630550|NCT01853332|Primary|Psychosocial Health Risk Factors Correlated With BMI|Correlations of scales with BMI score. Cumulative adversity occurring before age 18 was assessed using a) the Evaluation of Lifetime Stressors, b) SCID, and c) the Adult Attachment Interview. A cumulative adversity sum score was obtained (range 0-13; higher is more adversity). An overall adversity score was created by multiplying the number of childhood adversities × the overall severity of childhood adversity × the overall chronicity of childhood adversity. Scores for overall adversity ranged from 0 to 156 (higher is more adversity). The Social Adjustment Scale is a semi-structured interview assessing functioning in the preceding 2 months and ranges from 1 (excellent adjustment) to 7 (very poor adjustment). Psychosocial risk factors is an index of 1 to 3 (higher is more risk). Health risk score adds smoking, non-optimal drinking (>7/14 drinks/week for women/men), a score in the bottom tertile of the AHEI, and minimal exercise (<6 hours/week)and tallied (scores0-4 with higher worse).|2.5 years||||Pearson Correlation Coefficients|||Number
2630551|NCT01853332|Primary|Psychosocial Adversity|"Cumulative adversity occurring before age 18 was assessed using a) the Evaluation of Lifetime Stressors, b) SCID, and c) the Adult Attachment Interview. A cumulative adversity sum score was obtained (range 0-13, higher more).An overall adversity score was created by multiplying the number of childhood adversities×the overall severity of childhood adversity × the overall chronicity of childhood adversity. Scores for overall adversity ranged from 0 (no) to 156 more adversity).The Social Adjustment Scale is a semi-structured interview assessing functioning in the preceding 2 months and ranges from 1 (excellent) to 7 (very poor adjustment). An index score of psychosocial risk factors was created. Education less than a Bachelor's degree, unemployment, and a social adjustment scale score indicative of non-optimal functiong (≥ 3) were considered risk factors, coded as 1, and then tallied. Range of scores 0 (less)-3 (more risk)."|2.5 years||||units on a scale||Standard Deviation|Mean
2630552|NCT01853332|Primary|Hormonal Levels|"To assess clinically significant physical health outcomes including 1) establishing risk factors for CVD and type 2 diabetes mellitus (DM) 2) establishing novel risk factors for CVD and DM (e.g., inflammatory markers, hormonal mediators ), and 3) determining the prevalence of established CVD and DM.~Both insulin and glucose will be measured.~Adipokines.~Myokines.~Triglycerides and HDL cholesterol will be considered in light of their relevance to CVD.~Proinflammatory markers."|2.5 years||||ng/ml||Inter-Quartile Range|Mean
2630553|NCT01853280|Primary|Adult ADHD Investigator Symptom Rating Scale (AISRS)|The AISRS is an 18-item questionnaire administered by the clinician assessing each of the individual DSM-IV symptoms of ADHD. Each symptom is rated on a scale of severity from 0 (none) to 3 (severe), and the 18 symptom questions are summed to calculate a total score. The minimum total score is a 0, while the maximum total score is a 54. The AISRS was compared from baseline to completion, over the course of the 12 week study.|12 weeks|While 44 subjects were randomized to receive the study drug, only 41 subjects actually began taking the medication, and as such were evaluated using the AISRS.|||units on a scale||Standard Deviation|Mean
2630554|NCT01853254|Primary|Percentage of Participants With at Least 1 Adverse Event||From Baseline to the end of the study (up to 72 weeks)|All participants analysis set.|||Percentage of participants|||Number
2630555|NCT01853228|Primary|Phase 2: Percentage of Participants Who Achieved CR or CRi at End of Study Treatment|Response rate (percentage of participants who achieved CR or CRi) was measured using international working group (IWG) criteria. Response rate is defined as complete remission (CR) or complete remission with incomplete blood count recovery (CRi) in children with relapsed or refractory acute myeloid leukemia. CRi is defined as morphologic CR with residual neutropenia (less than [<] 1,000/microliter) or thrombocytopenia <100,000/ microliter). CR is defined as morphologic leukemia-free state, with less than 5 percentage (%) blasts in aspirate sample with marrow spicules and with a count of greater than or equal to (>=) 200 nucleated cells, plus absolute neutrophil count (ANC) greater than (>) 1,000/ microliter, platelet count of >100,000/microliter and participant must be independent of transfusions for a minimum of 1 week before each marrow assessment.|End of study treatment (approximately 3 years)|Population included all enrolled participants evaluable in Phase 2.|||percentage of participants|||Number
2630565|NCT01853228|Primary|Phase 1 and 2: Total Clearance of Decitabine|Total clearance of drug after intravenously administration was calculated as: dose/area under the plasma concentration-time curve.|Cycle 1 (28 days) Day 5: pre-infusion, 0.5 hour during infusion, end of infusion and at 5 minute (min), 0.5 hour, 1 hour, and 2 hour after end of infusion|Population included all enrolled participants in this study assessed for pharmacokinetics (PK). Pharmacokinetic analysis was planned to be reported for the overall participants including Phase 1 and 2. Here 'n' signifies number of participants analyzed for specified category.|||liter per hour per square meter||Full Range|Median
2630798|NCT01850030|Secondary|Percentage of Participants Being Pregnant as Measured by the Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer|Percentage of participants being pregnant as measured by the positive biochemical pregnancy test on Day 14 after embryo transfer|Day 14 after embryo transfer||||percentage of participants||95% Confidence Interval|Number
2630556|NCT01853228|Primary|Phase 2: Percentage of Participants Who Achieved CR or CRi at Cycle 2 Day 28|Response rate (percentage of participants who achieved CR or CRi) was measured using international working group (IWG) criteria. Response rate is defined as complete remission (CR) or complete remission with incomplete blood count recovery (CRi) in children with relapsed or refractory acute myeloid leukemia. CRi is defined as morphologic CR with residual neutropenia (less than [<] 1,000/microliter) or thrombocytopenia <100,000/ microliter). CR is defined as morphologic leukemia-free state, with less than 5 percentage (%) blasts in aspirate sample with marrow spicules and with a count of greater than or equal to (>=) 200 nucleated cells, plus absolute neutrophil count (ANC) greater than (>) 1,000/ microliter, platelet count of >100,000/microliter and participant must be independent of transfusions for a minimum of 1 week before each marrow assessment.|Cycle 2 (28 days) Day 28|Population included all enrolled participants evaluable in Phase 2. Here 'N' signifies number of participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2630557|NCT01853228|Primary|Phase 2: Percentage of Participants Who Achieved CR or CRi at Cycle 1 Day 28|Response rate (percentage of participants who achieved CR or CRi) was measured using international working group (IWG) criteria. Response rate is defined as complete remission (CR) or complete remission with incomplete blood count recovery (CRi) in children with relapsed or refractory acute myeloid leukemia. CRi is defined as morphologic CR with residual neutropenia (less than [<] 1,000/microliter) or thrombocytopenia <100,000/ microliter). CR is defined as morphologic leukemia-free state, with less than 5 percentage (%) blasts in aspirate sample with marrow spicules and with a count of greater than or equal to (>=) 200 nucleated cells, plus absolute neutrophil count (ANC) greater than (>) 1,000/ microliter, platelet count of >100,000/microliter and participant must be independent of transfusions for a minimum of 1 week before each marrow assessment.|Cycle 1 (28 days) Day 28|Population included all enrolled participants evaluable in Phase 2. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2630558|NCT01853228|Primary|Phase 1 and 2: Volume of Distribution at Steady-State (Vss) of Decitabine|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|Cycle 1 (28 days) Day 5: pre-infusion, 0.5 hour during infusion, end of infusion and at 5 min, 0.5 hour, 1 hour, and 2 hour after end of infusion|Population included all enrolled participants in this study assessed for PK. Pharmacokinetic analysis was planned to be reported for the overall participants including Phase 1 and 2. Here 'n' signifies number of participants analyzed for specified category.|||liter per square meter||Full Range|Median
2630559|NCT01853228|Secondary|Phase 1 and 2: Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)|TEAEs are defined as adverse events with onset or worsening on or after date of first dose of study treatment. An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.|Approximately 3 years 10 months|The safety analysis set included all enrolled participants who received at least 1 dose of study drug (DACOGEN). This outcome measure was planned to be reported for the overall participants including Phase 1 and 2.|||Participants|||Count of Participants
2630560|NCT01853228|Secondary|Phase 1 and 2: Event-Free Survival|Event free survival is defined as the time from first dose of study drug to relapse from CR, death, or second malignancy for participants who achieved CR. CR is defined as morphologic leukemia-free state, with less than 5 percentage (%) blasts in aspirate sample with marrow spicules and with a count of greater than or equal to (>=) 200 nucleated cells, plus absolute neutrophil count (ANC) greater than (>) 1,000/ microliter platelet count of >100,000/microliter and participant must be independent of transfusions for a minimum of 1 week before each marrow assessment.|From enrollment to progression/relapse, death, or withdrawal, whichever comes first, for up to approximately 3 years 10 months|Population included all enrolled participants in Phase 1 and Phase 2.|||days||Full Range|Median
2630561|NCT01853228|Secondary|Phase 1 and 2: Overall Survival (OS)|OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.|From enrollment to death or withdrawal, whichever comes first, for up to approximately 3 years 10 months|Population included all enrolled participants in Phase 1 and Phase 2.|||months||95% Confidence Interval|Median
2630562|NCT01853228|Secondary|Phase 2: Overall Response Rate|Overall response rate is defined as percentage of participants with complete remission (CR) +complete remission with incomplete blood count recovery (CRi)+partial remission (PR) per IWG Criteria. CRi: morphologic CR with residual neutropenia (less than [<] 1,000/microliter) or thrombocytopenia <100,000/microliter). CR is defined as morphologic leukemia-free state, with less than 5 percentage (%) blasts in aspirate sample with marrow spicules and with a count of greater than or equal to (>=) 200 nucleated cells, plus absolute neutrophil count (ANC) greater than (>) 1,000/ microliter platelet count of >100,000/microliter and participant must be independent of transfusions for a minimum of 1 week before each marrow assessment. PR: all the same hematologic values of a CR, but with a decrease of >=50% of the percentage of blasts to 5% to 25% in the bone marrow aspirate.|Up to approximately 3 years 10 months|Population included all enrolled participants evaluable in Phase 2.|||Percentage of participants|||Number
2630563|NCT01853228|Secondary|Phase 2: Duration of Response|Duration of response is defined as weeks from date of first response to date of first relapse or date of death.|From time of response to relapse, study completion/withdrawal, or death, whichever comes first, for up to approximately 3 years 10 months|Population included all enrolled participants who achieved CR or CRi response in Phase 2. There was insufficient data to perform Kaplan Meier analysis, therefore individual data for each evaluable participant was reported.|||weeks|||Number
2630564|NCT01853228|Secondary|Phase 1 and 2: Area Under the Plasma Concentration-Time Curve (AUC) of Decitabine|AUC is the area under the plasma concentration-time curve of decitabine.|Cycle 1 (28 days) Day 5: pre-infusion, 0.5 hour during infusion, end of infusion and at 5 min, 0.5 hour, 1 hour, and 2 hour after end of infusion|Population included all enrolled participants in this study assessed for PK. Pharmacokinetic analysis was planned to be reported for the overall participants including Phase 1 and 2. Here 'n' signifies number of participants analyzed for specified category.|||nanogram*hour per milliliter (ng*h/mL)||Full Range|Median
2654582|NCT01634269|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||30 days||||mmHg||Standard Deviation|Mean
2630566|NCT01853228|Secondary|Phase 1 and 2: Maximum Plasma Concentration (Cmax) of Decitabine|Cmax is the maximum observed plasma concentration of Decitabine.|Cycle 1 (28 days) Day 5: pre-infusion, 0.5 hour during infusion, end of infusion and at 5 min, 0.5 hour, 1 hour, and 2 hour after end of infusion|Population included all enrolled participants in this study assessed for PK. Pharmacokinetic analysis was planned to be reported for the overall participants including Phase 1 and 2. Here 'n' signifies number of participants analyzed for specified category.|||nanogram per milliliter (ng/mL)||Full Range|Median
2630567|NCT01853228|Primary|Phase 1: Maximum Tolerated Dose (MTD) of Cytarabine|The maximum tolerated dose (MTD) for cytarabine was based on the number of participants experiencing a dose-limiting toxicity (DLT) by the end of Cycle 1. A non-hematological DLT was defined as: any Grade >=3 toxicity that persists for greater than (>) 5 days or any Grade 2 toxicity that persists for >7 days and that is intolerable to the participant. A hematological DLT was defined as Grade 4 neutropenia or thrombocytopenia due to a hypoplastic bone marrow at Day 42, in the absence of malignant infiltration. The nominal duration of each cycle was 28 days. However, participants who had not experienced bone marrow recovery at Day 28 were followed up to Day 42. Failure of marrow recovery (improvement to Grade 3) by Day 42 was considered a DLT. The maximum duration of Cycle 1 was therefore 42 days.|Cycle 1 (42 days)|Population included participants who experienced a DLT by the end of Cycle 1.|||gram per square meter|||Number
2630568|NCT01853215|Secondary|300mmHg Infusion Flow Rates|Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 300 mmHg infusion.|during the 12 minute infusion time frame|Per protocol|||milliliters per hour||Standard Deviation|Mean
2630569|NCT01853215|Secondary|200mmHg Infusion Flow Rates|Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 200 mmHg infusion.|during the 12 minute infusion time frame|Per protocol|||milliliters per hour||Standard Deviation|Mean
2630570|NCT01853215|Secondary|100mmHg Infusion Flow Rates|Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a 100 mmHg infusion.|during the 12 minute infusion time frame|Per protocol|||milliliters per hour||Standard Deviation|Mean
2630571|NCT01853215|Secondary|Gravity Flow Rates|Measure the infusion flow rates attainable in the sternum when using intraosseous infusion of normal saline using a gravity infusion (no Pressure).|during the 12 minute infusion time frame|Per protocol|||milliliters per hour||Standard Deviation|Mean
2630572|NCT01853215|Secondary|Adhesion Strips|Perceived effeciveness of the device adhesion strips after application. A 1- 5 scale was used with 1=Poor; 2=Fair; 3=Good; $=Very good; 5=Excellent.|During insertion of the intraosseous needle set||||Likert scale||Standard Deviation|Mean
2630573|NCT01853215|Secondary|Stability of Catheter Hub|Ability to stabilize the catheter hub and rotate the stylet for removal. 1 to 5 scale was used with 1=Very difficult; 2-Difficult; 3=Neutral; 4=Easy; 5=Very easy.|During insertion of the intraosseous needle set||||Likert scale||Standard Deviation|Mean
2630574|NCT01853215|Secondary|Stability of Locator|"Operator's perceived stability of the sternal locator once placed on the subject.~1 to 5 scale was used with 1=Poor; 2=Fair; 3=Good; 4=Very good; 5=Excellent."|During insertion of the intraosseous needle set|Per protocol|||Likert scale||Standard Deviation|Mean
2630575|NCT01853215|Primary|Occurrences of Extravasation During Infusion|The number of occurrences of extravasation with intraosseous infusion as evidenced by contrast injection into the intraosseous catheter, visualized under fluoroscopic imaging.|during 12 minutes of infusion|Per protocol|||participants|||Number
2630576|NCT01853176|Primary|Pain Score, Visual Analogue Pain Scores|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain. Patients will complete a log of pain levels experienced each morning and evening for 3 days. Score is 0-10 on a visual analog scale.|3 days|||||||
2630577|NCT01853085|Primary|IOP in the Study Eye at Week 12|IOP is a measurement of the fluid pressure inside the study eye.|Week 12|All patients with data for this outcome measure|||mmHg||Standard Deviation|Mean
2630578|NCT01853085|Secondary|Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale|Physician assessment of patient compliance compared to previous therapy is assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.|12 Weeks|All patients with data for this outcome measure|||Patients|||Number
2630579|NCT01853085|Secondary|Number of Patients Who Continue Treatment|Patient continuation of treatment with Lumigan® UD after the end of study participation is assessed as Yes or No.|12 Weeks|All enrolled patients|||Patients|||Number
2630580|NCT01853085|Secondary|Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment|Patient discontinuation of treatment with Lumigan® UD prior to 12 weeks of treatment is assessed as Yes or No.|12 Weeks|All enrolled patients|||Patients|||Number
2630581|NCT01853085|Secondary|Physician Assessment of Tolerability on a 4-Point Scale|Physician assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|12 Weeks|All patients with data for this outcome measure|||Patients|||Number
2630582|NCT01853085|Secondary|Patient Assessment of Tolerability on a 4-Point Scale|Patient assessment of tolerability is assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|12 Weeks|All patients with data for this outcome measure|||Patients|||Number
2630583|NCT01853085|Secondary|Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale|IOP is a measurement of the fluid pressure inside the eye. Physicians evaluate IOP change from baseline in the study eye as better than expected, as expected, and worse than expected. The numbers of patients in each category are presented.|Baseline, 12 Weeks|All patients with data for this outcome measure|||Patients|||Number
2630584|NCT01853085|Primary|Intraocular Pressure (IOP) in the Study Eye at Baseline|IOP is a measurement of the fluid pressure inside the study eye.|Baseline|All patients with data for this outcome measure|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2630585|NCT01853072|Secondary|Percentage of Participants With With a > 10-letter Loss in BCVA From Day 7 to Any Visit||Day 7 up to any visit through Day 90|Full analysis set|||percentage of participants|||Number
2630586|NCT01853072|Secondary|Percentage of Participants With a > 5-letter Loss in BCVA From Day 7 to Any Visit [Time Frame: Day 7 up to Any Visit]||Day 7 up to any visit through Day 90|Full analysis set|||percentage of participants|||Number
2630589|NCT01853072|Primary|Percentage of Participants Who Develop Macular Edema Within 90 Days Following Cataract Surgery (Day 0)|Macular edema was defined as ≥ 30% Increase from pre-operative baseline in central subfield macular thickness, as measured with Spectral Domain Ocular Coherence Tomography (SD-OCT). One eye (study eye) contributed to the analysis.|Day 0 to Day 90|Full analysis set|||Percentage of participants|||Number
2630590|NCT01853072|Primary|Percentage of Participants With Best-corrected Visual Acuity (BCVA) Improvement of ≥ 15 Letters From Preoperative Baseline to Day 14 and Maintained Through Day 90|BCVA (with spectacles or other visual corrective devices) was reported in letters read correctly, using the Early Treatment Diabetic Retinopathy Study (ETDRS) test of 70 letters. Improvement of BCVA was defined as an increase (gain) in the number of letters read, compared to the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline to Day 14, and maintained through Day 90|Full analysis set|||Percentage of participants|||Number
2630591|NCT01853046|Other Pre-specified|Tumor Response Assessment for Measurable Lesions According to RECIST, v1.1 (Response Evaluation Criteria in Solid Tumors)|"Positron emission tomography - computed tomography (ET-CT), CT, or magnetic resonance imaging (MRI) scans of all anatomic regions involved with the disease were performed to assess tumor response using the Response Evaluation Criteria in Solid Tumors, Version 1.1. (RECIST v1.1). Bone metastases were assessed by bone scintigraphy (bone scan). Tumor measurements and evaluation of tumor response were performed at baseline and within the last 7 days of Cycle 2. Thereafter, if subjects continued regorafenib treatment, tumor assessments were performed after every third cycle and at the end-of-treatment (EOT) visit. In addition, outcome of Assessment of Bone Metastases by Scintigraphy if Applicable (Bone Scan) was registered, the results of which has been reported as tumor response in this outcome as well."|Up to 6 months|Participants in the Normal/mild renal impairment group had only tumor assessments at screening, thus excluded from efficacy analysis.|||participants|||Number
2630592|NCT01853046|Secondary|AE,ur(10-24) Stage 2 for Metabolites M-7 and M-8|based on non-compartmental PK evaluation|Days 21-22: 10-24 hours|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||percentage of dose||Standard Deviation|Mean
2630593|NCT01853046|Secondary|AE,ur(0-10) Stage 2 for Metabolites M-7 and M-8|based on non-compartmental PK evaluation|Days 21-22: 0-10 hours|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||percentage of dose||Standard Deviation|Mean
2630594|NCT01853046|Secondary|AE,ur(10-24) Stage 1 ((Amount of Drug Excreted Via Urine During the Collection Interval 10-24 Hours Post Administration) for Metabolites M-7 and M-8|based on non-compartmental PK evaluation|Days 1-2: 10-24 hours|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||percentage of dose||Standard Deviation|Mean
2630595|NCT01853046|Secondary|AE,ur(0-10) Stage 1 (Amount of Drug Excreted Via Urine During the Collection Interval 0-10 Hours Post Administration) for Metabolites M-7 and M-8|based on non-compartmental PK evaluation|Days 1-2: 0-10 hours|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||percentage of dose||Standard Deviation|Mean
2630596|NCT01853046|Secondary|AE,ur(0-24)md (AE,ur(0-24) After Multiple-dose Administration) for Metabolites M-7 and M-8|based on non-compartmental PK evaluation|Days 21-22: 0-24 hours|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||percentage of dose||Standard Deviation|Mean
2630597|NCT01853046|Secondary|RLin (Linearity Factor Calculated as Ratio From AUC(0-24)md and AUC) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. RLin is the linearity factor of PK after multiple administrations of identical doses calculated as ratio of AUC(0-24)md and AUC.|Up to 25 days|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||Linearity factor calculated as ratio||Geometric Coefficient of Variation|Geometric Mean
2630598|NCT01853046|Secondary|RAAUC (Accumulation Ratio Calculated From AUC(0-24)md and AUC(0-24)) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. RAAUC calculated as ratio of AUC(0-24)md and AUC(0-24).|Up to 25 days|In Normal/mild renal impairment group, participants analyzed for regorafenib, M-2 and M-5 are n=13, 13 and 12 respectively. In Severe renal impairment group, participants analyzed for regorafenib, M-2 and M-5 are n=4, 4 and 3 respectively. Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||Accumulation Ratio||Geometric Coefficient of Variation|Geometric Mean
2630599|NCT01853046|Secondary|RACmax (Accumulation Ratio Calculated From Cmax,md and Cmax) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. Accumulation ratio based on maximum plasma concentration (Cmax) was calculated as ratio of Cmax,md and Cmax.|Up to 25 days|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||Accumulation Ratio||Geometric Coefficient of Variation|Geometric Mean
2630600|NCT01853046|Secondary|Tlast,md (Tlast After Multiple-dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|based on non-compartmental PK evaluation|Days 21-25: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||h||Full Range|Median
2630601|NCT01853046|Secondary|Tmax,md (Time to Reach Maximum Drug Concentration in Plasma After Multiple-dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|based on non-compartmental PK evaluation|Days 21-25: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||h||Full Range|Median
2630602|NCT01853046|Secondary|AUC(0-tlast)md (AUC(0-tlast) After Multiple-dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|based on non-compartmental PK evaluation.|Days 21-25: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
2630603|NCT01853046|Secondary|Cmax,md (Cmax After Multiple-dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation.Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Days 21-25: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||mg/L||Geometric Coefficient of Variation|Geometric Mean
2630604|NCT01853046|Secondary|AUC(0-24)md ((AUC(0-24) After Multiple-dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation.|Days 21-25: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10 and 24 hours post-dose|In Normal/mild renal impairment group, number of participants analyzed is 13. In Severe renal impairment group, number of participants analyzed is 4. Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
2630605|NCT01853046|Secondary|Vz/F (Apparent Volume of Distribution During Terminal Phase After Single (First) Oral Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation.Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||L||Geometric Coefficient of Variation|Geometric Mean
2630606|NCT01853046|Secondary|CL/F (Total Body Clearance of Drug After Extravascular Administration) After Single (First) Dose for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation.Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||L/H||Geometric Coefficient of Variation|Geometric Mean
2630607|NCT01853046|Secondary|t1/2 (Half-life Associated With the Terminal Slope) After Single (First) Dose for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. t1/2 refers to the elimination of the drug. It is the time taken for the blood plasma concentration to reach half the concentration in the terminal phase of elimination. It is expressed in hours (h) and derived from the terminal slope of the concentration versus time curve.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||h||Geometric Coefficient of Variation|Geometric Mean
2630608|NCT01853046|Secondary|Tlast (Time of Last Data Point >LLOQ) After Single (First) Dose for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|based on non-compartmental PK evaluation.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose||||h||Full Range|Median
2630609|NCT01853046|Secondary|Tmax (Time to Reach Maximum Drug Concentration in Plasma After Single (First) Dose) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation.Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose||||h||Full Range|Median
2630610|NCT01853046|Secondary|Cmax (Maximum Drug Concentration in Plasma After Single (First) Dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation.Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose||||mg/L||Geometric Coefficient of Variation|Geometric Mean
2630611|NCT01853046|Secondary|AUC(0-24) (AUC From Time Zero to 24 Hours p.a. After Single (First) Dose Administration) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; AUC(0-24) is defined as AUC divided from zero to 24 hours after single (first) dose.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10 and 24 hours post-dose|In Normal/mild renal impairment group, participants analyzed for regorafenib, M-2 and M-5 are n=18, 18, and 17 respectively. In Severe renal impairment group, participants analyzed for regorafenib, M-2 and M-5 are n=6, 6, and 5 respectively. Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
2630612|NCT01853046|Secondary|AUC (Area Under the Plasma Concentration vs. Time Curve From Zero to Infinity After Single (First) Dose) for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
2630613|NCT01853046|Primary|AE,ur(0-24) (Amount of Drug Excreted Via Urine During the Collection Interval 0-24 Hours Post Administration) for Metabolites M-7 and M-8|Amount of drug excreted into urine during the collection interval 0-24 hours post dose was expressed as percentage of administered dose.|Days 1-2: 0-24 hours|Participants with a valid pharmacokinetic profile for non compartmental analysis were reported.|||percentage of dose||Standard Deviation|Mean
2630614|NCT01853046|Primary|AUC(0-tlast) [Area Under the Concentration-time Curve After Single (First) Dose From Time Zero to the Last Data Point >LLOQ (Lower Limit of Quantification)] for Regorafenib and Its Pharmacologically Active Metabolites M-2 and M-5|Based on non-compartmental PK evaluation. The AUC(0-tlast) [Area Under the Concentration-time Curve After Single (First) Dose From Time Zero to the Last Data Point >LLOQ (Lower Limit of Quantification)] is a measure of systemic drug exposure from time 0 up to the time point at which the last measurable drug could be detectable, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|Days 1-5: Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 and 96 hours post-dose||||mg*h/L||Geometric Coefficient of Variation|Geometric Mean
2630699|NCT01852032|Primary|Beta of Tomosynthesis Medial Lateral Oblique View|"frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B.~beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection)."|Day 1|Participants with suspected breast cancer|||power-law slope(B)||Standard Deviation|Mean
2630615|NCT01852955|Secondary|Postoperative Pain in the Post Anesthesia Care Unit|Postoperative pain within the post anesthesia care unit after surgery. Area under the numeric rating scale for pain versus time curve in the post anesthesia care unit (score * min).Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve in the post anesthesia care unit ( score * min). Area under a curve units of the horizontal axis multiplied by the units of the vertical axis. A higher value indicates more pain and time in the Post Anesthesia Care Unit.The range is 0 pain to x time in minutes x 1 hour to 5 hour ( 60-300 minutes) . The pain scores were collected at 15 minute intervals from the time of admission to the PACU. The area under the NRS pain scale versus time curve was calculated using the trapezoidal method as an indicator of pain burden during early recovery (Graph Pad Prism ver 5.03, Graph Pad Software INC.|Time in the post anesthesia care unit after surgery (average of 5 hours)||||(units on a scale * minutes||Inter-Quartile Range|Median
2630616|NCT01852955|Secondary|Postoperative Opioid Consumption|Postoperative opioid consumption over 24 hours. Converted into oral mg of morpine equivalents.|24 hour||||oral mg of morpine equivalents||Inter-Quartile Range|Median
2630617|NCT01852955|Primary|Quality of Recovery at 24 Hours(QoR-40 Instrument)|Quality of recovery score 24 hours after the surgical procedure. Total score range of 40 (poor recovery) and a score of 200 (good recovery).|24 hours after the surgical procedure||||units on a scale||Inter-Quartile Range|Median
2630618|NCT01852825|Secondary|Change From Baseline in Time Weighted Average (TWA) Over 1 Hour Pre-NAC Through 1 Hour Post-NAC Visual Analog Score (VAS) for Sneezing, Rhinorrhea, Congestion and Nasal Itch Following 12 Weeks of Treatment (Part 2)|A visual analog scale (VAS) representing the spectrum of symptoms from absent (0) to extremely severe (100) for each of rhinorrhea, nasal blockage, sneezing and nasal itch were summed to obtain an overall score. The range of VAS overall score is 0 - 400, with higher numbers representing worse symptoms. The models for the time-weighted mean (TWA) of the summed scores over 1 hour pre-NAC through hour 1 following NAC were constructed at the original scale.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2630619|NCT01852825|Secondary|Change From Baseline in 6.5 Hours Post-NAC Nasal Epithelial Eosinophil-related Messenger RNA (mRNA) Signature Following 12 Weeks of Treatment (Part 2)|Blood was collected from participants treated with D. pteronyssinus and D.farinae HDM and then with either MK-8237 or placebo, and the levels of nasal epithelial eosinophil-related mRNA signature 6.5 hours after NAC in serum at baseline and at week 12 were measured. The mRNA signature is derived from nine gene transcripts which were measured using the NanoString nCounter Gene Expression Assay. Positive control and pre-specified housekeeping gene normalization methods recommended by nSolver were used to normalize the transcripts. The average of the expression level of the nine genes was used to describe the eosinophil mRNA signature. Fold change from baseline and between-treatment comparison was evaluated based on cLDA method with log transformed data. Least squares geometric means are presented.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.|||Fold change||95% Confidence Interval|Least Squares Mean
2630620|NCT01852825|Secondary|Change From Baseline in 6.5 Hours Post-NAC Interleukin-5 (IL-5) Protein Concentration in Nasal Exudates Following 12 Weeks of Treatment (Part 2)|Blood was collected from participants treated with D. pteronyssinus and D.farinae HDM and then with either MK-8237 or placebo, and the levels of Il-5 protein 6.5 hours after NAC in serum at baseline and at week 12 were measured. Fold change from baseline and between-treatment comparison was evaluated based on cLDA method with log transformed data. IL-5 protein concentration was measured in nasal exudates collected both pre- and post-nasal challenge. Least squares geometric means are presented.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.|||Fold change||95% Confidence Interval|Least Squares Mean
2630621|NCT01852825|Primary|Change From Baseline in HDM-specific IgE Blocking Factor (IgE-BF) in Serum at 12 Weeks|Blood was collected from participants treated with D. pteronyssinus and D.farinae HDM and then with either MK-8237 or placebo, and the amount of IgE-BF in serum was measured based on an Ordinary IgE measurement and an assay in the presence of Competitors; with IgE-BF = 1 - (Competitive IgE/Ordinary IgE). This ranges from 0 (no IgE blocked) to 1 (all IgE blocked); and as it is based on a ratio there are no units. Change from baseline (12 weeks minus baseline) was evaluated based on cLDA method, and was analyzed based on the original scale. The model included time (categorical variable), treatment, and time by treatment interaction as fixed effects and participants as random effect. It is hypothesized that the change from baseline is statistically greater with MK-8237 treatment than with placebo. This hypothesis is supported if the lower bound of the 1-tailed 95% CI around the 12 week mean difference in change from baseline in HDM-specific IgE blocking factor response excludes zero.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.|||Ratio||95% Confidence Interval|Least Squares Mean
2630622|NCT01852825|Primary|Change From Baseline in D. Pteronyssinus HDM-specific IgG4 Antibodies in Serum at 12 Weeks (Part 2)|Blood was collected from participants treated with D. pteronyssinus HDM, and then with MK-8237 or placebo, and the amount of HDM-specific IgG4 antibodies in serum at baseline and at week 12 were measured. Fold change from baseline was evaluated based on cLDA method with log transformed data. The model included time (categorical variable), treatment, and time by treatment interaction as fixed effects and participants as random effect. Least squares geometric means are presented. It is hypothesized that the change from baseline is statistically greater with MK-8237 treatment than with placebo. This hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the geometric mean fold difference is >1.0.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.|||Fold Change||95% Confidence Interval|Geometric Mean
2630750|NCT01850641|Secondary|Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)||12 weeks|Full Analysis Set|||pg/mL||Standard Deviation|Mean
2630623|NCT01852825|Primary|Change From Baseline in D. Farinae HDM-specific IgG4 Antibodies in Serum at 12 Weeks (Part 2)|Blood was collected from participants treated with Dermatophagoides (D.) farinae HDM and then with MK-8237 or placebo, and the amount of HDM-specific IgG4 antibodies in serum at baseline and at week 12 were measured. Fold change from baseline was evaluated based on constrained longitudinal data analysis (cLDA) method with log transformed data. The model included time (categorical variable), treatment, and time by treatment interaction as fixed effects and participants as random effect. Least squares geometric means are presented. It is hypothesized that the change from baseline is statistically greater with MK-8237 treatment than with placebo. This hypothesis is supported if the lower bound of the two-sided 90% confidence interval for the geometric mean fold difference is >1.0.|Baseline and 12 weeks|All randomized participants from Part 2 who are compliant with the study procedures and have available data from at least one treatment. Participants from Part 1 were not analyzed because they were not treated with MK-8237 or placebo.|||Fold Change||95% Confidence Interval|Geometric Mean
2630624|NCT01852812|Primary|Apparent Elimination Half-life (t1/2) of Montelukast CT and Montelukast OG|Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.|Up to Day 28 after first dose of study drug|The ASPE population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group.|||Hours||Standard Deviation|Mean
2630625|NCT01852812|Primary|Time to Cmax (Tmax) of Montelukast CT and Montelukast OG|Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.|Up to Day 28 after first dose of study drug|The ASPE population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group.|||Hours||Standard Deviation|Mean
2630626|NCT01852812|Primary|Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG|Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.|Up to Day 28 after first dose of study drug|The ASPE population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group.|||ng/mL||Standard Deviation|Mean
2630627|NCT01852812|Primary|Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG|Blood samples for pharmacokinetic (PK) assessments were collected at either 1 hour (h) or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28.|Up to Day 28 after first dose of study drug|The All Subjects Pharmacokinetically Evaluable (ASPE) population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group.|||h*ng/mL||Standard Deviation|Mean
2630628|NCT01852812|Primary|Percentage of Participants Who Discontinue Study Drug Due to an AE|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of study drug is also an AE. Discontinuations due to an AE were reported based on the dose of study drug participants received.|Up to 12 weeks|The ASaT population consisted of all participants who received at least one dose of study drug. Data from the two montelukast 5 mg CT groups (6-9 year olds and 10-15 year olds) were pooled for safety analyses.|||Percentage of participants|||Number
2630629|NCT01852812|Primary|Percentage of Participants Who Experience at Least One Adverse Event (AE)|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of study drug is also an AE. Participants were monitored for the occurrence of AEs for up to 14 days after last dose of study drug (up to a total of 14 weeks). AEs were reported based on the dose of study drug participants received.|Up to 14 days after last dose of study drug (Up to 14 weeks)|The All Subjects as Treated (ASaT) population consisted of all participants who received at least one dose of study drug. Data from the two montelukast 5 mg CT groups (6-9 year olds and 10-15 year olds) were pooled for safety analyses.|||Percentage of participants|||Number
2630630|NCT01852799|Other Pre-specified|Evaluation of Responses(PFS)|Efficacy parameters PFS will be evaluated by normal methodology. PFS =（date of signing informed consent form minus the date of first documented progression or date of death from any cause plus 1）/30.5（months）|From date of signing informed consent form until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months||||months||95% Confidence Interval|Median
2630631|NCT01852799|Other Pre-specified|Safety Evaluation|Safety evaluations will be based on scheduled physical examinations, Eastern Cooperative Oncology Group(ECOG) scores, vital signs (blood pressure, heart rate) and clinical laboratory tests.|Starting with informed consent signature through study completion, an average of 1 year||||Participants|||Count of Participants
2630632|NCT01852799|Other Pre-specified|Evaluation of Responses|Evaluation of responses was performed every cycle. Responses were assessed according to the european group for blood and marrow transplantation（EBMT） criteria (An attempt will be made to collect data for the assessment of stringent complete response (sCR) if these data are available.). Other efficacy parameters including PFS and 1-year overall survival rate and overall survival will be evaluated by normal methodology. According to EBMT criteria, responses were assessed by changes in the level of the serum paraprotein and/or urinary light chain excretion.The specific assessment rules may refer to EBMT criteria for MM.|At baseline, on day 28 of cycles 4, and after 4, 6, 12 and 18 months of follow-up||||Participants|||Count of Participants
2630751|NCT01850641|Secondary|Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)||12 weeks|Full Analysis Set|||mg/dL||Standard Deviation|Mean
2630752|NCT01850641|Secondary|Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)||12 weeks|Full Analysis Set|||mg/dL||Standard Deviation|Mean
2630633|NCT01852799|Secondary|Skeletal Related Events' Evaluation|Skeletal survey of the skeleton using plain radiography will be performed at baseline, on day 28 of cycle 4, and after 6, 12 and 18 months of follow-up or until start of alternative MM treatment, if earlier. SREs, such as pathological fractures, need for radiation therapy or surgery will be recorded at the time of the event.|At baseline, on day 28 of cycles 4, and after 4, 6, 12 and 18 months of follow-up or until start of alternative MM treatment|Data were not collected.||||||
2630634|NCT01852799|Secondary|Measurement of Bone Mineral Density|The effect on bone mineral density（BMD） will be measured by quantitative analysis of qCT scans of the intra-individual same region [lumbar spine and hip] at baseline, on day 28 of cycles 4, and after 4, 6, 12 and 18 months of follow-up or until start of alternative MM treatment, if earlier.|At baseline, on day 28 of cycles 1,4, and after 4, 6, 12 and 18 months of follow-up or until start of alternative MM treatment|Data were not collected.||||||
2630635|NCT01852799|Primary|Bone Formation Markers Measurement|The bone formation marker- bone alkaline phosphatase(bALP) and osteoblast inhibitor- Dickkopf-1(DKK-1）are measured on serum samples by ELISA methodology at baseline, on day 28 of cycles 1,4, and after 4, 6, 12 and 18 months of follow-up or until start of alternative multiple myeloma(MM) treatment, if earlier.|Up to Cycle 4 with 28 days per cycle||||U/L||Standard Deviation|Mean
2630636|NCT01852669|Primary|Number of Participants Who Are Stone Free at 3 Months|To compare the effectiveness of simultaneous adjunct controlled inversion therapy during extracorporeal shockwave lithotripsy (ESWL) to that of ESWL alone in the treatment of lower pole caliceal stone as measured by stone-free rate(SFR)|3 months||||participants|||Number
2630637|NCT01852591|Secondary|CD8+CD107a+, Best Response Against Vaccine (CRM 197)|Best CD8+ response against CRM197 at day +30 for CD107a. Peripheral Blood Mononuclear Cells (PBMCs) were incubated with CRM197, or control. Cells were harvested and stained for flow cytometry.|30 Days Post Vaccine|All evaluable participants.|||percentage of CD8 cells|||Number
2630638|NCT01852591|Secondary|CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)|Best CD8+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry. Highest percentage increase of CD8 cells from pre-vaccine to Day + 30.|30 Days Post Vaccine|All evaluable participants.|||percentage of CD8 cells|||Number
2630639|NCT01852591|Secondary|CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)|Best CD4+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet (CTV) then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry.|30 Days Post Vaccine|All evaluable participants.|||percentage of CD4 cells|||Number
2630640|NCT01852591|Primary|Number of Participants With Immune Response|Positive response per test category. Post-vaccination result higher than pre-vaccination values for each test category criteria. Additional details are reported under Secondary Outcome Measures.|30 Days Post Vaccine|All evaluable participants.|||participants|||Number
2630641|NCT01852383|Other Pre-specified|Maximum Duloxetine Oral Dose|Maximum duloxetine oral dose|Week 0, 1, 2, 4, 6, 8, 10, 12||||mg||Standard Deviation|Mean
2630642|NCT01852383|Secondary|Change in Cornell Dysthymia Rating Scale Scores From Week 0 to Week 12|Cornell Dysthymia Rating Scale scores from range 0-64. Lower or decreasing scores represent decreased severity and a better outcome, while higher or increasing scores represent more severe depression and a worse outcome. The change score was calculated by subtracting the Week 12 score from the Week 0 score.|Week 0 and 12||||units on a scale||Standard Deviation|Mean
2630643|NCT01852383|Other Pre-specified|Change in the Treatment Emergent Symptom Scale (TESS) Total Score From Week 0 to Week 12.|The Treatment Emergent Symptom Scale (TESS) documents the presence of common side effects. There are 26 items and the total score range is 0-26. Low scores or decrease in scores represent less side effects and high scores or increase in scores represent more side effects. The change in side effect severity scores was calculated by subtracting the Week 12 score from the Week 0 score.|0 and 12 weeks||||units on a scale||Standard Deviation|Mean
2630644|NCT01852383|Primary|Change in Hamilton Rating Scale for Depression (HAM-D, 24-item) From 0 Weeks to 12 Weeks.|The research rater completed the 24-item Hamilton Rating Scale for Depression (HAM-D) and documented the scores on each visit. Hamilton Rating Scale for Depression scores range from 0-50 with low scores or decreasing scores representing decreased severity and better outcome, and higher scores or increasing scores representing more severe depressive symptoms and a worse outcome. The change score was calculated by subtracting the Week 12 score from the Week 0 score.|Screen (0) and 12 weeks||||units on a scale||Standard Deviation|Mean
2630645|NCT01852344|Secondary|Reaction Time Variability on the Multi-Source Interference Task.|Reaction time variability on the Multi-Source Interference task is defined as the number of milliseconds between an individual's lowest and highest reaction time. This is averaged across all participants.|20-30 minutes|Participants whose accuracy on task one fell below 80% or who were greater than two standard deviation outliers in reaction time were excluded from analysis.|||milliseconds||Standard Deviation|Mean
2630646|NCT01852344|Secondary|Accuracy on the Multi-Source Interference Task.|Patients completed 200 trials and the percentage of answers correct was calculated.|20-30 minutes|Participants whose accuracy on task one fell below 80% or who were greater than two standard deviation outliers in reaction time were excluded from analysis.|||percentage of answers which were correct||Standard Deviation|Mean
2630647|NCT01852344|Primary|Reaction Time on the Multi-Source Interference Task|Reaction time on the Multi-Source Interference Task is measured in milliseconds. Participants were given 200 trials and their mean reaction time was calculated.|20-30 minutes for task completion|Participants whose accuracy on task one fell below 80% or who were greater than two standard deviation outliers in reaction time were excluded from analysis.|||milliseconds||Standard Deviation|Mean
2630668|NCT01852201|Secondary|Percentage of Participants Mortality at 90 Days|Mortality at 90 days will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected.|90 days||||percentage of participants|||Number
2630753|NCT01850641|Primary|Incidence of Adverse Events||12 weeks|Safety Set|||Participants|||Count of Participants
2630648|NCT01852292|Secondary|Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for CL/F|To characterize the pharmacokinetics of buparlisib given in combination with paclitaxel for CL/F.|Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15|Full Sampling Pharmacokinetic Analysis Set (FPAS): All pts in PAS who received planned dose of buparlisib every day for last consecutive 7 days before full PK profile assessment on C1D15, didn’t vomit within 4 hours of buparlisib dosing, had at least 1 dose of paclitaxel before collection of PK sample for PK profile & had evaluable full PK profile|||L/hr||Full Range|Median
2630649|NCT01852292|Secondary|Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for Tmax|To characterize the pharmacokinetics of buparlisib given in combination with paclitaxel for Tmax.|Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15|Full Sampling Pharmacokinetic Analysis Set (FPAS): All pts in PAS who received planned dose of buparlisib every day for last consecutive 7 days before full PK profile assessment on C1D15, didn’t vomit within 4 hours of buparlisib dosing, had at least 1 dose of paclitaxel before collection of PK sample for PK profile & had evaluable full PK profile|||hour (hr)||Full Range|Median
2630650|NCT01852292|Secondary|Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for Cmax|To characterize the pharmacokinetics of buparlisib given in combination with paclitaxel for Cmax.|Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15|Full Sampling Pharmacokinetic Analysis Set (FPAS): All pts in PAS who received planned dose of buparlisib every day for last consecutive 7 days before full PK profile assessment on C1D15, didn’t vomit within 4 hours of buparlisib dosing, had at least 1 dose of paclitaxel before collection of PK sample for PK profile & had evaluable full PK profile|||ng/mL||Full Range|Median
2630651|NCT01852292|Secondary|Plasma Concentration-time Profiles of BKM120 Pharmacokinetics (PK) for AUC0-24 and AUClast|To Characterize PK of buparlisib given in combination with paclitaxel for AUC0-24 (area under plasma concentration-time curve from time 0 to end of dosing interval of 24 hours) & AUClast (AUC from time 0 to last measurable concentration sampling time).|Time point(s) at which PK samples for Non-Compartmental analysis were collected were 0, 0.5,1,1.5, 2, 3, 4, 6, 9 and 24 hours at Cycle 1, Day 15|Full Sampling Pharmacokinetic Analysis Set (FPAS): All pts in PAS who received planned dose of buparlisib every day for last consecutive 7 days before full PK profile assessment on C1D15, didn’t vomit within 4 hours of buparlisib dosing, had at least 1 dose of paclitaxel before collection of PK sample for PK profile & had evaluable full PK profile|||ng*hr/mL||Full Range|Median
2630652|NCT01852292|Secondary|Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Head and Neck Cancer Symptoms Scales for Pain, Speech Problems, Swallowing and Sense Problems Per EORTC-QLQ-HN35|A summary of EORTC-QLQ-HN35 scores by time window. Time to deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen. Definitive Deterioration in global health status and symptoms was defined as an increase in the subscale score of at least 10% compared to baseline, with no later decrease above this threshold observed during the course of the study. If a patient had not had an event prior to analysis cut-off or start of another anticancer therapy, time to deterioration was censored at the date of the last quality of life (QoL) evaluation.|Baseline, every 6 weeks starting from cycle 2 day 15 up to 3.5 years|The Full analysis set (FAS) includes all patients who were randomized to study treatment.|||Months||95% Confidence Interval|Median
2630653|NCT01852292|Secondary|Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Global Health Status/Quality of Life Per EORTC-QLQ-C30|A summary of EORTC-QLQ-C30 scores by time window. Time to deterioration is the number of days between the date of randomization and the date of the assessment at which definitive deterioration is seen. Definitive Deterioration in global health status and symptoms was defined as a decrease in the subscale score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. If a patient had not had an event prior to analysis cut-off or start of another anticancer therapy, time to deterioration was censored at the date of the last quality of life (QoL) evaluation.|Baseline, every 6 weeks starting from cycle 2 day 15 up to 3.5 years|The Full analysis set (FAS) includes all patients who were randomized to study treatment.|||months||95% Confidence Interval|Median
2630654|NCT01852292|Secondary|Duration of Response (DoR) as Per Local Investigator|DoR is the time from the date of the first documented response (CR or PR, which had to be confirmed subsequently) to the date of the first radiologically documented disease progression or death due to disease according to RECIST v1.1 .|4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years|The Full analysis set (FAS) includes all patients who were randomized to study treatment.|||months||Full Range|Median
2630655|NCT01852292|Secondary|Disease Control Rate (DCR) as Per Local Radiological Assessment|DCR is the percentage of patients with a best overall response of CR, PR or stable disease (SD), according to RECIST v1.1. CR is defined as disappearance of all target lesions & any pathological lymph nodes must have a short axis of <10 mm & the disappearance of all non-target lesions). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm). SD is defined as neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm^2.|4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years|The Full analysis set (FAS) includes all patients who were randomized to study treatment.|||Percentage of participants||95% Confidence Interval|Number
2630669|NCT01852201|Secondary|Percentage of Participants Mortality at 30 Days|Mortality at 30 days will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected.|30 days|The values for 4 subjects was not captured at this timepoint|||percentage of participants|||Number
2630656|NCT01852292|Secondary|Time to Response (TTR) as Per Local Radiological Assessment|TTR is the time from date of randomization until first documented response (CR or PR, which has to be confirmed subsequently) according to RECIST v1.1. CR is defined as disappearance of all target lesions and any pathological lymph nodes must have a short axis of <10 mm and the disappearance of all non-target lesions). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm).|4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years|The Full analysis set (FAS) includes all patients who were randomized to study treatment.|||months||Full Range|Median
2630657|NCT01852292|Secondary|Overall Response Rate (ORR) as Per Local Radiological Assessment|ORR: percentage of patients with best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1. CR is defined as disappearance of all target lesions and any pathological lymph nodes must have a short axis of <10 mm and the disappearance of all non-target lesions). PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm).|4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years|The Full analysis set (FAS) includes all patients who were randomized to study treatment.|||Percentage of participants||95% Confidence Interval|Median
2630658|NCT01852292|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last contact.|4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years|The Full analysis set (FAS) includes all patients who were randomized to study treatment.|||months||95% Confidence Interval|Median
2630659|NCT01852292|Primary|Progression Free Survival (PFS) Per Investigator Assessment|PFS was defined as the time from the date of randomization to the date of the event, defined as the first radiologically documented disease progression per RECIST v. 1.1 or death due to any cause. If a patient has not progressed or died at the analysis cut-off date or when the patient receives further anti-neoplastic therapy, PFS was censored on the date of the last adequate tumor assessment before the earlier of the cut-off date or start of the further anti-neoplastic therapy date.|4 weeks and thereafter every 6 weeks until disease progression or death up to 3.5 years|The Full analysis set (FAS) includes all patients who were randomized to study treatment.|||months||95% Confidence Interval|Median
2630660|NCT01852214|Secondary|Platelet Reactivity Index|The comparison of the platelet reactivity index (PRI) values determined by vasodilator-stimulated phosphoprotein (VASP) between both treatments (ticagrelor or prasugrel). VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies. A low PRI is indicative of high platelet inhibition.|2 hours||||PRI||95% Confidence Interval|Least Squares Mean
2630661|NCT01852214|Secondary|Platelet Reactivity Index|The comparison of the platelet reactivity index (PRI) values determined by vasodilator-stimulated phosphoprotein (VASP) between both treatments (ticagrelor or prasugrel). VASP was measured by quantitative flow cytometry using commercially available labelled monoclonal antibodies. A low PRI is indicative of high platelet inhibition.|1 week||||PRI||95% Confidence Interval|Least Squares Mean
2630662|NCT01852214|Secondary|P2Y12 Reaction Units|Comparison of the P2Y12 reaction units (PRU) values determined by VerifyNow between both treatments (ticagrelor or prasugrel)|2 hours||||PRU||95% Confidence Interval|Least Squares Mean
2630663|NCT01852214|Primary|P2Y12 Reaction Units|The primary endpoint is the comparison of the P2Y12 reaction units (PRU) values determined by VerifyNow between both treatments (ticagrelor or prasugrel). Treatment effects were evaluated comparing PRU observed in the overall patient population after prasugrel treatment with those achieved after ticagrelor regardless of the sequence.|1 week|All analyses of platelet function conducted on all randomized subjects who received study drug, successfully completed at least one treatment period of the study and had valid data for the primary end point.|||PRU||95% Confidence Interval|Least Squares Mean
2630664|NCT01852201|Secondary|Percentage of Patients With Serious Adverse Events (SAEs) Related to Thrombectomy Device.|A Thrombectomy device is a device intended to restore blood flow in a vessel in the brain by removing a blood clot (thrombus).|90 days||||percentage of participants|||Number
2630665|NCT01852201|Secondary|Arterial Revascularization Measured by TICI 2b or 3 Following Device Use|Arterial revascularization measured by TICI 2b or 3 following device use will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected.|90 days||||percentage of participants|||Number
2630666|NCT01852201|Secondary|Percentage of Participants With SAE's Related to a Thrombectomy Procedure|"A Thrombectomy is an interventional procedure to remove a blood clot (thrombus) from a blood vessel in the brain.~Procedure related SAE's will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected."|90 days||||Percentage of participants|||Number
2630667|NCT01852201|Secondary|Percentage of Participants With ICH (Intracranial Hemorrhage) With Neurological Deterioration (NIHSS Worsening >4).|ICH with neurological deterioration (NIHSS worsening >4) will be compared between randomized groups in an ITT fashion; with overall Type I error controlled using hierarchical testing. That is, if statistical significance is observed on the primary effectiveness endpoint, the secondary clinical efficacy endpoints will then be tested in sequential fashion each at a two-sided alpha level of 0.05, with testing ceasing once a null hypothesis cannot be rejected.|90 days|One patient had no NIHSS scores after baseline and was excluded from this analysis|||percentage of participants|||Number
2630799|NCT01850030|Primary|Percentage of Participants Being Pregnant as Measured by the Presence of Fetal Heart Beats at 12 Weeks´Gestation Using Transvaginal Ultrasound|Percentage of participants being pregnant as measured by the presence of fetal heart beats at 12 weeks´gestation using transvaginal ultrasound|12 weeks´ gestation (at visit 6)||||percentage of participants||95% Confidence Interval|Number
2630670|NCT01852201|Secondary|Percentage of Participants in the 6-12hr Cohort With Good Functional Recovery as Assessed by the Modified Rankin Scale (mRS)|The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. A score of 0-2 represents good functional recovery. The scores are defined as follows: (0) No symptoms at all; (1) No significant disability despite symptoms, able to carry out all usual duties and activities; (2) Slight disability, unable to carry out all previous activities, but able to look after own affairs without assistance.|90 days||||Percentage of particpants|||Number
2630671|NCT01852201|Secondary|Percentage of Participants in the 6-12 hr Cohort With Global Disability as Assessed by the Modified Rankin Score (mRS)|The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. A score of 3-6 represents global disability are defined as follows: (3) moderate disability (requiring some help, but able to walk without assistance); (4) moderate severe disability (unable to walk without assistance and unable to attend to own bodily needs without assistance); (5) severe disability (bedridden, incontinent and requiring constant nursing care and attention; and (6) dead.|90 day|There were only 12 participants total in the 6-12hr cohort|||percentage of participants|||Number
2630672|NCT01852201|Primary|Rate of Good Functional Outcomes Measured by Modified Rankin Score (mRS)|"Modified rankin score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The range is 0-6 (0 is highest function with no symptoms and 6 is death). This outcome measured percentage of subjects with a good functional outcome with a score ranging from 0-2.~The primary objective is to show that AIS patients, ineligible for or refractory to treatment with IV-tPA, (patients seen within 6 hours of symptom onset will be immediately considered for endovascular therapy according to the site's standard of care. Likewise, patients presenting beyond 12 hours will be treated according to the site's standard of care), with appropriate image selection, treated with mechanical thrombectomy within 6-12 hours of symptom onset have less stroke related disability and improved good functional outcomes as compared to those treated with best MT."|90 days||||percentage of participants|||Number
2630673|NCT01852175|Secondary|Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)|A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 24 hours after loading dose.|24 hours||||PRI%||Standard Error|Least Squares Mean
2630674|NCT01852175|Secondary|Platelet Reactivity Measured by Vasodilator-stimulated Phosphoprotein (VASP)|A secondary outcome was the comparison between groups of platelet reactivity index (PRI) measured by vasodilator-stimulated phosphoprotein (VASP) at 2 hours after loading dose.|2 hours||||PRI%||Standard Error|Least Squares Mean
2630675|NCT01852175|Primary|Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP)|The primary end-point of the study was the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) at 1 week between prasugrel and ticagrelor.|1 week||||PRI%||Standard Error|Least Squares Mean
2630676|NCT01852162|Secondary|Clot Kinetic: Clot Stength|Clot strength (maximal amplitude:MA) was assessed by thromboelastography.|1-week|Clot kinetic assessed by citrated-kaolin thromboelastography|||mm||Standard Deviation|Mean
2630677|NCT01852162|Secondary|Clot Kinetic: Thrombin Activity|Parameters related to thrombin activity and velocity of thrombus generation (reaction time: R; time to maximum rate of thrombus generation: TMRTG) were evaluated by thromboelastography.|1-week|Clot kinetic assessed by citrated-kaolin thromboelastography|||minutes||Standard Deviation|Mean
2630678|NCT01852162|Secondary|Platelet Reactivity Measured by Multiple Electrode Aggregometry.|Multiple measures of platelet reactivity evaluating purinergic and non-purinergic signaling pathways were assessed by multiple electrode aggregometry.|1-week|Platelet aggregation measured by multiple electrode aggregometry.|||arbitrary aggregation units||Standard Deviation|Mean
2630679|NCT01852162|Secondary|Platelet Reactivity Measured by LTA|Multiple measures of platelet reactivity evaluating purinergic and non-purinergic signaling pathways were assessed by light transmittance aggregometry (LTA).|1-week|Platelet aggregation measured by LTA|||percentage of aggregation||Standard Deviation|Mean
2630680|NCT01852162|Primary|TRAP-induced Platelet Aggregation|TRAP-induced platelet aggregation measured by light transmittance aggregometry (LTA) was similar between groups|1 week|TRAP-induced platelet aggregation|||percentage of aggregation||Standard Deviation|Mean
2630681|NCT01852110|Secondary|Change From Baseline in CCS-3D at Week 12 (Stage 2, MK-7622 45 mg and 15 mg Versus Placebo)|CCS-3D is composed of individual cognitive tests, grouped into 3 domains: 1) episodic memory; 2) executive function; and 3) attention/processing speed. For each cognitive test, a z-score (Z) is calculated at each time point [Z = (observed value - study population mean at baseline) / study population standard deviation at baseline]. These individual Zs are first combined into domain-specific Zs, and then into a composite Z, (i.e. CCS-3D). Theoretically, 99.9% of CCS-3D will be ± 3; more positive CCS-3D indicate greater cognitive impairment relative to the total study population at baseline. Further, negative changes in CCS-3D over time indicate improved cognition relative to the total study population at baseline.|Baseline and Week 12|Per study protocol, the analysis population was to include only randomized participants in Stage 2 receiving ≥1 dose of placebo, MK-7622 – 15 mg, or MK-7622 – 45 mg, having either a baseline or 12-week CCS-3D assessment. Study terminated before Stage 2 enrollment; no data were collected for this outcome measure.||||||
2630682|NCT01852110|Secondary|Change From Baseline in Composite Cognition Score-3 Domain (CCS-3D) at Week 12 (Stage 1, MK-7622 45 mg Versus Placebo)|CCS-3D is composed of individual cognitive tests, grouped into 3 domains: 1) episodic memory; 2) executive function; and 3) attention/processing speed. For each cognitive test, a z-score (Z) is calculated at each time point [Z = (observed value - study population mean at baseline) / study population standard deviation at baseline]. These individual Zs are first combined into domain-specific Zs, and then into a composite Z, (i.e. CCS-3D). Theoretically, 99.9% of CCS-3D will be ± 3; more positive CCS-3D indicate greater cognitive impairment relative to the total study population at baseline. Further, negative changes in CCS-3D over time indicate improved cognition relative to the total study population at baseline.|Baseline and week 12|All randomized participants in Stage 1 receiving ≥1 dose of study medication, having either a baseline or 12-week CCS-3D assessment.|||z-score||Standard Error|Mean
2659833|NCT01585961|Primary|Total Procedure Time||Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.|||minutes||Standard Deviation|Mean
2630683|NCT01852110|Secondary|Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL) at Week 24 (Combining Stage 1 and 2, MK-7622 45 mg Versus Placebo)|Mean change from baseline at week 24 was assessed for ADCS-ADL score. The ADCS-ADL score measures the performance of activities of daily living, calculated from a 24-question survey. For each of the 24 questions, scores range from 0 (no independence) to (depending on the question) either 2 (1 question), 3 (17 questions), 4 (5 questions), or 5 (1 question), with higher scores indicating greater independence in activity performance. Scores from individual questions are summed into a total ADCS-ADL score, with potential total scores ranging from 0 to 78. Lower scores indicate less independence in activity performance and, as a result, greater AD severity. Further, increases in AD severity over time would be reflected by decreases in ADCS-ADL score.|Baseline and week 24|Per protocol, analysis population was to include all randomized participants (pooled across Stages 1 and 2) receiving ≥1 dose of placebo or MK-7622 – 45 mg, having either a baseline or 24-week ADCS-ADL assessment. As the study was terminated before Stage 2 enrollment, only participants in Stage 1 were analyzed.|||Score on a Scale||Standard Error|Mean
2630684|NCT01852110|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|The number of participants discontinuing study drug due to an AE was assessed.|Up to 24 weeks|All participants as treated, consisting of all participants (Stages 1 and 2) who received study medication. Study terminated before Stage 2 enrollment; no data were collected for Stage 2-specific arms.|||Participants|||Count of Participants
2630685|NCT01852110|Primary|Number of Participants Experiencing an Adverse Event (AE)|The number of participants experiencing an adverse event (AE) was assessed. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening of a preexisting condition that is temporally associated with the use of the study treatment is also considered an AE.|Up to 26 weeks|All participants as treated, consisting of all participants (Stages 1 and 2) who received study medication. Study terminated before Stage 2 enrollment; no data were collected for Stage 2-specific arms.|||Participants|||Count of Participants
2630686|NCT01852110|Primary|Change From Baseline in ADAS-Cog11 Score at Week 12 (Stage 2, MK-7622 45 mg and 15 mg Versus Placebo)|Mean change from baseline at week 12 was assessed for ADAS-Cog11 score. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in Alzheimer's Disease (AD): speech; speech comprehension; word finding; word recall; object/finger naming; orientation; obeying commands; ideational praxis; constructional praxis; word recognition; and remembering instruction. For each metric, scores range from 0 (no impairment) to (depending on the metric) either 5 (8 metrics), 8, 10, or 12 (1 metric each); higher scores indicate more severe impairment. Individual scores sum to a total ADAS-Cog11 score, ranging from 0-70. Higher total scores indicate greater cognitive impairment and AD severity. Further, increases in AD severity over time would be reflected by increases in ADAS-Cog11 score.|Baseline and week 12|Per study protocol, the analysis population was to include only randomized participants in Stage 2 receiving ≥1 dose of placebo, MK-7622 – 15 mg, or MK-7622 – 45 mg, having either a baseline or 12-week ADAS-Cog11 assessment. Study terminated before Stage 2 enrollment; no data were collected for this outcome measure.||||||
2630687|NCT01852110|Primary|Change From Baseline in the 11-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at Week 12 (Stage 1, MK-7622 45 mg Versus Placebo)|Mean change from baseline at week 12 was assessed for ADAS-Cog11 score. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in Alzheimer's Disease (AD): speech; speech comprehension; word finding; word recall; object/finger naming; orientation; obeying commands; ideational praxis; constructional praxis; word recognition; and remembering instruction. For each metric, scores range from 0 (no impairment) to (depending on the metric) either 5 (8 metrics), 8, 10, or 12 (1 metric each); higher scores indicate more severe impairment. Individual scores sum to a total ADAS-Cog11 score, ranging from 0-70. Higher total scores indicate greater cognitive impairment and AD severity. Further, increases in AD severity over time would be reflected by increases in ADAS-Cog11 score.|Baseline and week 12|All randomized participants in Stage 1 receiving ≥1 dose of study medication, having either a baseline or 12-week ADAS-Cog11 assessment.|||Score on a Scale||Standard Error|Mean
2630688|NCT01852045|Secondary|Time to Participant Qualification for Retreatment|In order to qualify for retreatment, the criteria listed below must be fulfilled at the qualification for retreatment visit: Participant/parent/caregiver requests retreatment, participant has a total of at least 2 daytime urinary incontinence episodes over the 2-day bladder diary collection period, at least 12 weeks has elapsed since treatment 1 and participant has not experienced a serious treatment-related adverse event at any time.|48 weeks|mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Number analyzed is number of participants with non-missing values at the specified Visit.|||weeks||95% Confidence Interval|Median
2630689|NCT01852045|Secondary|Time to Participant Request for Retreatment|Time from treatment on Day 1 to request for retreatment was estimated. For those participants who did not request retreatment, their data was censored using the date of their last study visit.|48 weeks|mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Number analyzed is number of participants with non-missing values at the specified Visit.|||weeks||95% Confidence Interval|Median
2630690|NCT01852045|Secondary|Change From Baseline in Detrusor Leak Point Pressure (DLPP) During the Storage Phase|DLPP was defined as the lowest detrusor pressure at which urine leakage occurs in the absence of either a detrusor contraction or increased intra-abdominal pressure. Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the pressure inside of the bladder to see how well the bladder was working. A negative change from Baseline indicates improvement. Least squares estimates are based on an ANCOVA model.|Baseline (Day -28 to -1) to Week 6|mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Only participants who experienced a leak during urodynamics are included in the analysis.|||cm H2O||Standard Deviation|Mean
2630691|NCT01852045|Secondary|Change From Baseline in Maximum Detrusor Pressure (PdetMax) During the Storage Phase|Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the pressure inside of the bladder to see how well the bladder was working. A negative change from Baseline indicates improvement. Least squares estimates were based on an ANCOVA model.|Baseline (Day 1) to Week 6|mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Number analyzed is number of participants with non-missing values at the specified Visit.|||cm H2O||Standard Error|Least Squares Mean
2630692|NCT01852045|Secondary|Change From Baseline in Maximum Detrusor Pressure During the First IDC (PdetMax1stIDC) in Participants With IDC|Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the pressure inside of the bladder to see how well the bladder was working. A negative change from Baseline indicates improvement. Least squares estimates were based on an ANCOVA model.|Baseline (Day-28 to Day-1) to Week 6|mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Only participants who experienced an IDC are included in the analysis.|||centimeters of water (cm H2O)||Standard Error|Least Squares Mean
2630693|NCT01852045|Secondary|Percentage of Participants With Involuntary Detrusor Contractions (IDC)|Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the presence of involuntary detrusor contractions upon filling. A reduction in IDCs from Baseline to Week 6 indicates improvement.|Baseline (Day -28 to -1) and Week 6|mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Number analyzed is number of participants with non-missing values at the specified Visit.|||percentage of participants||95% Confidence Interval|Number
2630694|NCT01852045|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|The MCC was defined by urodynamics, as the volume infused before the participant felt they could no longer delay micturition (has a strong desire to void), had a leakage, or 500 mL was instilled. A positive change from Baseline indicates improvement (increase) in the maximum volume of urine the bladder holds. Least squares estimates were based on an ANCOVA model.|Baseline (Day -28 to Day -1) to Week 6|mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Number analyzed is number of participants with non-missing values at the specified Visit.|||mL||Standard Error|Least Squares Mean
2630695|NCT01852045|Secondary|Percentage of Participants With Night Time Urinary Incontinence|Urinary incontinence was defined as involuntary loss of urine and the presence or absence of night time urinary incontinence was recorded by the participant in a bladder diary in the 2 consecutive days (normalized to a 12-hour daytime period) during the week prior to the study visit. Night time was defined as the time between going to bed to sleep for the night and waking up to start the day. The percentage of participants with night time urinary incontinence is presented in categories (0, 1, 2 nights).|Baseline (Day -28 to Day -1), Week 6|mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Number analyzed is number of participants with non-missing values at the specified Visit.|||percentage of participants|||Number
2630696|NCT01852045|Secondary|Change From Baseline in Average Urine Volume at First Morning Catheterization|The change in urine volume at first morning catherization was recorded by the participant in a bladder diary in the 2 consecutive days during the week prior to the study visit. A positive change from Baseline indicates improvement. Least squares estimates were based on an ANCOVA model.|Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6|mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Number analyzed is number of participants with non-missing values at the specified Visit.|||milliliters (mL)||Standard Error|Least Squares Mean
2630697|NCT01852045|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|An adverse event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as any new adverse event or worsening of an existing condition after initiation of treatment.|First study treatment to 12 weeks after last treatment (Up to 48 weeks after first study injection)|Safety population included participants who underwent treatment procedure and received study drug on randomization/Day 1, except those who received less dose due to 6 U/kg weight cap, were allocated to nearest dose group based on the actual dose received.|||Participants|||Count of Participants
2630698|NCT01852045|Primary|Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes|Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 2 consecutive days (normalized to a 12-hour daytime period) prior to the study visit. Daytime was defined as the time between waking up to start the day and first morning catheterization and going to bed to sleep for the night. The number of incontinence episodes were averaged daily during this period. A negative change from Baseline indicates improvement. Least squares estimates were based on an Analysis of Covariance (ANCOVA) model.|Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6|mITT population included participants who received study drug on Day 1, analyzed on as-randomized basis, except those who received less than their randomized dose due to weight and dose limit of 6 U/kg, allocated to nearest dose group based on dose received. Missing data are imputed up to Week 6 using Last Observation Carried Forward (LOCF) method.|||urinary incontinence episodes per day||Standard Error|Least Squares Mean
2630700|NCT01852032|Primary|Beta of Tomosynthesis Craniocaudal View|"frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B.~beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection)."|Day 1|Participants with suspected breast cancer|||power-law slope(B)||Standard Deviation|Mean
2630701|NCT01852032|Primary|Beta of CT Axial View|"frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B.~beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection)."|Day 1|Participants with suspected breast cancer|||power-law slope(B)||Standard Deviation|Mean
2630702|NCT01852032|Primary|Beta of CT Sagittal View|"frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B.~beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection)."|Day 1|Participants with suspected breast cancer|||power-law slope(B)||Standard Deviation|Mean
2630703|NCT01852032|Primary|Beta of CT Coronal View|"frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B.~beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection)."|Day 1|Participants with suspected breast cancer|||power-law slope(B)||Standard Deviation|Mean
2630704|NCT01852019|Secondary|Bleeding Events in Accordance With the GUSTO Scale|Bleeding was assessed by history, physical exam, and complete blood count (CBC) that was performed on study Days 1 and 8. Reports of bleeding were to be evaluated by performance of a CBC. Bleeding was to be reported as recommended and quantified in accordance with the GUSTO criteria [The GUSTO Investigators, 1993].|Day 1 through Day 8||||participants|||Number
2630705|NCT01852019|Secondary|Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone|A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay.|Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion|Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.|||platelet reaction units (PRU)||Standard Deviation|Mean
2630706|NCT01852019|Secondary|Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)|A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence of absence of the study drugs was examined for each of the endpoints as assessed by platelet reaction units (PRU) from the VerifyNow P2Y12 assay.|Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.|Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.|||platelet reaction units (PRU)||Standard Deviation|Mean
2630707|NCT01852019|Primary|Extent of Preservation of Inhibitory Effect of Cangrelor Treatment After Prasugrel, Compared to Treatment With Cangrelor Alone|A reference point for the inhibitory effect of cangrelor alone was chosen for comparison and designated the first draw during the cangrelor infusion (1.0 or 1.5 hours) or within 5 minutes post cangrelor infusion on Day 1. The extent of aggregation was observed during the cangrelor infusion on Day 8, either 24 or 48 hours after discontinuation of prasugrel using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 μM adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).|Day 8 - at 1.0 and 2.0 hours after initiation of cangrelor infusion|Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.|||% aggregation||Standard Deviation|Mean
2630708|NCT01852019|Primary|Extent of Preservation of Inhibitory Effect After Transition From Cangrelor to Prasugrel Compared With Effect Observed With Prasugrel Alone (Reference Timepoint)|A reference point for the effect of prasugrel alone was chosen for comparison and designated the final draw on study Day 1 (3.5 or 4.0 hours after cangrelor had been discontinued) as the reference for the effect of prasugrel. The extent of aggregation in the presence or absence of the study drugs was examined for each of the endpoints using light transmittance aggregometry (LTA) and expressed as % aggregation in response to 20 micromolar (μM) adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).|Day 1 measures taken at timepoints after cangrelor infusion end to end of Day 1 measures.|Subjects treated with cangrelor and prasugrel were used for the analysis and presentation of data.|||% aggregation||Standard Deviation|Mean
2630709|NCT01851876|Primary|Clinical Pregnancy Rate||4 months||||participants|||Number
2630710|NCT01851876|Primary|Clinical Pregnancy Rate||up to 6 months|||||||
2630711|NCT01851863|Other Pre-specified|Number of Participants With Adverse Reaction|Number of participants with adverse reactions were recorded to analyze the safety profile of treatment.|8 weeks||||participants|||Number
2630712|NCT01851863|Secondary|Change From Baseline in Psychiatric Symptom on Hospital Anxiety and Depression Scale at Week 8|Each patient was surveyed using the Hospital Anxiety and Depression Scale to assess the psychiatric symptom at week 0 and 8.The HADS consists of 14 items, seven of which assess anxiety, and seven assess depression. The anxiety and depression subscales were calculated independently. The patients were asked to answer each item on a four-point (0 - 3) scale. Scores of 0 to 7 on either subscale can be regarded as within the normal range, scores of 8 to 10 are suggestive of the presence of the respective state, and scores of 11 or higher indicate the probable presence of the respective mood disorder. The change of HADS scores was calculated by HADS anxiety and depression scores of 8 weeks minus baseline, with lower values indicate better outcome.|week 0 and 8||||units on HADS score||Full Range|Mean
2630754|NCT01850615|Secondary|Number of Adverse Events|All adverse events (AEs) described here refer to treatment emergent adverse events (TEAE). A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment, week 18.|Weeks 0-18|The SAS included all subjects receiving at least one dose of the investigational product or its comparator.|||Number of events|||Number
2630713|NCT01851863|Secondary|Change From Baseline in Dyspepsia Symptom Questionnaire at Week 8|The severity of patients' dyspeptic symptoms were assessed using the Leeds Dyspepsia Questionnaire (LDQ) at week 0 and 8. The LDQ contains eight items about epigastric pain, retro-sternal pain, regurgitation, nausea, vomiting, belching, early satiety and dysphagia with six grades for each item and a sum of the eight symptom scores make the LDQ score.LDQ scores of 0 - 4 were classified as very mild dyspepsia, 4 - 8 as mild dyspepsia, 9 -15 as moderate dyspepsia, and > 15 as severe or very severe dyspepsia. The change of LDQ scores was calculated by LDQ scores of 8 weeks minus baseline, with lower values represent a better outcome.|week 0 and 8||||units on LDQ scale||Full Range|Mean
2630714|NCT01851863|Primary|Compliance of Flupentixol-Melitracen|The patients were asked to keep a diary to record their medication intake. At each visit (weeks 1, 2, 4, 8), the patient bring back the drug bottle and the diary, then the physician recorded the number of pills remaining in the bottle. Pills remained more than 20% at any visit or seven days of consecutive abstinence were adopted as the criterion for identifying therapy noncompliance.|weeks 1, 2, 4, 8||||participants|||Number
2630715|NCT01851772|Other Pre-specified|Frequency of Adverse Events in Participants (i.e.Safety)|To assess occurrence rate of radiation toxicities through three (3) months of follow-up.|3 months post-Study Exit||||participants|||Number
2630716|NCT01851772|Secondary|Device Performance|Number of subjects who received complete delivery of the brachytherapy treatment using the Xoft Electronic Brachytherapy System with the cervical applicator.|Study Exit (90 days)||||participants|||Number
2630717|NCT01851772|Primary|Safety|Adverse event rate and severity during and following the administration of brachytherapy treatment, through discharge from the treatment facility, and for 3 months after treatment.|Study Exit (90 days)|Diagnosis of locally advanced cervical cancer (Stages Ib2-IVA).|||percentage of participants and severity|||Number
2630718|NCT01851720|Primary|Acute Pain Following Sub-Arachnoid Hemorrhage (SAH) is the Primary Outcome Variable and Will be Assessed Using the Numeric Rating Scale (NRS).|Pain score 0-10. 0 represented no pain and 10 worst pain|4 days|Though one subject in the PCA arm completed enrollment, we had insufficient data to perform any comparative analysis. We do no intend to summarize the patient's results.||||||
2630719|NCT01851655|Other Pre-specified|Change in Anterior Knee Laxity|Anterior knee laxity will be assessed with a knee arthrometer and a maximum manual pull. The side-to-side difference will be recorded in mm. The change will be computed as (post-intervention difference minus pre-intervention difference).|Baseline (pre-intervention) to 9 weeks (post-intervention)||||mm||Standard Deviation|Mean
2630720|NCT01851655|Other Pre-specified|Change in Fear of Movement/Re-injury|The 11-item version of the Tampa Scale for Kinesiophobia will be used to assess kinesiophobia or fear of movement/re-injury. Scores range from 11 to 44 points, and higher scores equal higher fear of movement/re-injury. Responses will be recorded on hard-copy and entered into a spreadsheet to calculate the score. The change will be computed as (post-intervention score minus pre-intervention score).|Baseline (pre-intervention) to 9 weeks (post-intervention)||||units on a scale||Standard Deviation|Mean
2630721|NCT01851655|Other Pre-specified|Change in Quadriceps Strength|Knee extensor torque will be measured with an isokinetic dynamometer. The lever arm will move at 60 degrees/second. The peak torque from 5 trials will be obtained and normalized to body weight. The change will be computed as (post-intervention value minus pre-intervention value)|Baseline (pre-intervention) to 9 weeks (post-intervention)||||ft-lb/lb||Standard Deviation|Mean
2630722|NCT01851655|Secondary|Change in the Ratio of Urinary CTXII to Serum CPII Concentrations.|CTX-II is a biomarker of Type II articular cartilage degradation. Type II collagen carboxy propeptide (CPII) is a biomarker of Type II collagen synthesis. Early morning urine and blood samples will be collected pre- and post-treatment. Urinary CTX-II will be analyzed as described in Primary Outcomes. Serum CPII will be determined using enzyme-linked immunosorbent assay. Values of both biomarkers will be log-transformed, and the ratio of CTXII:CPII will be calculated. The change will be computed as (post-intervention CTXII:CPII values minus pre-intervention CTXII:CPII value).|Baseline (pre-intervention) to 9 weeks (post-intervention)||||log [(ng/mmol)/(ng/mL)]||Standard Deviation|Mean
2630723|NCT01851655|Secondary|Change in Vertical Jump Height.|Vertical jump height will be assessed with the Vertex. The average of three trials will be recorded in cm. The change in vertical jump height will be computed as (post-intervention value minus pre-intervention value).|Baseline (pre-intervention) to 9 weeks (post-intervention)||||cm||Standard Deviation|Mean
2630724|NCT01851655|Primary|Change in Urinary Concentrations of the C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)|CTX-II is a biomarker of Type II collagen degradation. Early morning, second-void urine samples will be collected and stored. Concentrations of CTX-II will be determined with enzyme-linked immunosorbent assay and corrected for creatinine concentration, which will also be determined with enzyme-linked immunosorbent assay. Values will be log-transformed. The change in urinary CTX-II concentration will be computed as (post-intervention value minus pre-intervention value).|Baseline (pre-intervention) to 9 weeks (post-intervention)||||log-scale transformed value of ng/mmol||Standard Deviation|Mean
2630725|NCT01851655|Primary|Change in International Knee Documentation Committee (IKDC) Subjective Form Score.|The IKDC subjective form is a measure of self-reported knee function. It includes items related to symptoms and functional activities. Scores range from 0 to 100 points, and higher scores equal higher function. Responses will be recorded on hard-copy and entered into a spreadsheet to calculate the score. The change will be computed as (post-intervention score minus pre-intervention score).|Baseline (pre-intervention) to 9 weeks (post-intervention)||||units on a scale||Standard Deviation|Mean
2630726|NCT01851590|Secondary|Compliance to the Treatment|Evaluation of compliance was based on patient self-reports of whether the treatment protocol was followed 100% (complete), 80% (good), 60% (moderate), or 40% (poor) of the time.|At 4-month time-point|Percentage describes the proportion of patients who declared that they have been followed the instructions completely (100%).|||percentage of participants|||Number
2630727|NCT01851590|Secondary|Cost-effectiveness 2|Cost analysis was based on the retail price (€) and consumption of a 10 ml bottle of Abicin® 30% resin lacquer, a 5 ml bottle of Loceryl® 5% amorolfine lacquer, and 98 tablets of generic 250 mg terbinafine, sold by the University Pharmacy in Helsinki, Finland, January 2014. The cost was expressed as the average treatment cost per patient; for the total cost, this average was extrapolated to the entire study treatment arm. The results show the treatment costs (€) during the treatment period per patient in each group.|At 10-month time-point||||Euros (€)||95% Confidence Interval|Mean
2630728|NCT01851590|Secondary|Cost-effectiveness 1|Cost analysis was based on the retail price (€) and consumption of a 10 ml bottle of Abicin® 30% resin lacquer, a 5 ml bottle of Loceryl® 5% amorolfine lacquer, and 98 tablets of generic 250 mg terbinafine, sold by the University Pharmacy in Helsinki, Finland, January 2014. The cost was expressed as the average treatment cost per patient; for the total cost, this average was extrapolated to the entire study treatment arm. The results show the treatment costs (€) per day per patient in each group.|At 10-month time-point||||Euros (€)||95% Confidence Interval|Mean
2630729|NCT01851590|Secondary|Clinical Responses to the Treatments|Clinical responses to treatment were based on the proximal linear growth of healthy nail; thus, the clinical responses were classified as partial (evident proximal linear growth of healthy nail) or complete. Partial responses were defined as significant reductions in onycholysis, subungual hyperkeratosis, and streaks. A complete response was a fully normal appearance of the toenail.|At 4- and 10 months time-points from the beginning of the study.|Intention-to-treat population, last observation carried forward.|||percentage of participants|||Number
2630730|NCT01851590|Primary|Mycological Cure|To analyze the rate of complete mycological cure i.e. fungal eradication in terms of negative mycological culture AND negative potassium hydroxide (KOH) stain at 4- and 10 months time-points from the beginning of the study.|At 4- and 10 months time-points from the beginning of the study.|Primary and secondary outcome analyses were based on the intent-to-treat (ITT) population and missing values were imputed using the last observation carried forward (LOCF) method.|||Percentage of participants||95% Confidence Interval|Number
2630731|NCT01851330|Secondary|Percentage of Participants Experiencing Virologic Failure|"Virologic failure was defined as on-treatment virologic failure or virologic relapse.~On-Treatment Virologic Failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline to posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2630732|NCT01851330|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with Available Data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2630733|NCT01851330|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with Available Data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2630734|NCT01851330|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with Available Data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2630735|NCT01851330|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with Available Data were analyzed.|||percentage of participants|||Number
2630736|NCT01851330|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with Available Data were analyzed.|||percentage of participants|||Number
2630737|NCT01851330|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Participants in the Full Analysis Set with Available Data were analyzed.|||percentage of participants|||Number
2630738|NCT01851330|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
2630739|NCT01851330|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug|The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.|Up to 12 weeks|Safety Analysis Set|||percentage of participants|||Number
2630740|NCT01851330|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants were randomized and received at least one dose of study medication.|||percentage of participants|||Number
2630741|NCT01851174|Secondary|Progression Free Survival Time|Determine progression free survival time with this regimen|One year|The information required here was not captured. The investigator(s) are no longer at the site and no additional information or instruction was left. Data were not collected||||||
2630742|NCT01851174|Primary|Overall Survival Based on Toxicity Profile of Adverse Events.|Determine the toxicity profile (decrease in hematological and non-hematological treatment-related AE's) with bi-weekly dosing of gemcitabine plus nab-Paclitaxel|One year|The information required here was not captured. The investigator(s) are no longer at the site and no additional information or instruction was left.||||||
2630743|NCT01850745|Secondary|Efficacy of Treatment Measured by Sustained Virological Response|"The secondary efficacy end point was to evaluate the sustained virological response (SVR) of antiviral treatment.~SVR was defined as undetectable hepatitis C virus viral load (<15 IU/ml) 24 weeks after treatment completion.~Non-SVR was defined as detectable hepatitis C virus viral load (>15 IU/ml) 24 weeks after treatment completion."|baseline and 72 weeks|||||||
2630744|NCT01850745|Primary|Adherence to Treatment|"Adherent patients were defined as those receiving equal or more than 80% of total dose of pegylated interferon (180 microg/week) and ribavirin (1200 mg/d) during equal o more than 80% of duration treatment (48 weeks).~Non-adherent patients were defined as those receiving less than 80% of total dose of pegylated interferon (180 microg/week) and ribavirin (1200 mg/d) during less than 80% of duration treatment (48 weeks)."|48 months||||participants|||Number
2630745|NCT01850641|Secondary|Satisfaction With Bowel Movement||12 weeks|Safety Set|||Participants|||Count of Participants
2630746|NCT01850641|Secondary|Constipation Condition||12 weeks|Safety Set|||Participants|||Count of Participants
2630747|NCT01850641|Secondary|Hb Concentrations at End of Treatment (Actual Measured Value)||12 weeks|Safety Set|||g/dL||Standard Deviation|Mean
2630748|NCT01850641|Secondary|TSAT at End of Treatment (Actual Measured Value)||12 weeks|Safety Set|||percentage of TSAT||Standard Deviation|Mean
2630749|NCT01850641|Secondary|Serum Ferritin Concentrations at End of Treatment (Actual Measured Value)||12 weeks|Safety Set|||ng/mL||Inter-Quartile Range|Median
2630755|NCT01850615|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|Plasma glucose (PG) was measured and recorded when a hypoglycaemic episode was suspected. All PG values ≤3.9 mmol/L (70 mg/dL) or >3.9 mmol/L (70 mg/dL) when they occurred in conjunction with hypoglycaemic symptoms were recorded by the subject. Numbers of treatment emergent hypoglycaemic episodes were recorded during 18 weeks of treatment.|Weeks 0-18|The Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or its comparator.|||Number of episodes|||Number
2630756|NCT01850615|Secondary|Change From Baseline in Body Weight|"For this endpoint, baseline (week 0) and week 18 data are presented, where week 18 data are the end of trial data containing last available measurements."|Week 0, week 18|FAS included all randomised subjects.|||Kg||Standard Deviation|Mean
2630757|NCT01850615|Secondary|Self-measured Plasma Glucose (SMPG) 7-point Profile: Prandial Plasma Glucose (PG) Increment, Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)|"For this endpoint the end of trial data containing last available measurements are presented. Prandial PG increment for each meal (breakfast, lunch, main evening meal) was derived from the 7-point profiles (SMPG) as the difference between the PPG value 2 hours after each meal and the PG value before each meal. Individual mean meal PPG (post-breakfast, post-lunch, post-main evening meal) was derived from the three measurements."|After 18 weeks of randomised treatment|FAS included all randomised subjects. Number analysed for individual time-points = treatment wise number of subjects who contributed to analysis.|||mmol/L||Standard Deviation|Mean
2630758|NCT01850615|Secondary|Self-measured Plasma Glucose (SMPG) 7-point Profile: Post Prandial Plasma Glucose (PPG), Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal)|"For this endpoint the end of trial data containing last available measurements are presented. PPG measurements were recorded by the subjects at 2 hours after each meal (breakfast, lunch and main evening meal) as part of three 7-point profiles (SMPG) prior to the visits. Individual mean meal PPG (post-breakfast, post-lunch, post-main evening meal) was derived from the three measurements."|After 18 weeks of randomised treatment|FAS included all randomised subjects. Number analysed for individual time-points = treatment wise number of subjects who contributed to analysis.|||mmol/L||Standard Deviation|Mean
2630759|NCT01850615|Primary|Change From Baseline in HbA1c|"For this endpoint, baseline (week 0) and week 18 data are presented, where week 18 data are the end of trial data containing last available measurements."|Week 0, week 18|Full analysis set included all randomised subjects.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
2630760|NCT01850602|Secondary|Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)||12 weeks|Per Protocol Set|||pg/mL||Standard Deviation|Mean
2630761|NCT01850602|Secondary|Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)||12 weeks|Per Protocol Set|||mg/dL||Standard Deviation|Mean
2630762|NCT01850602|Secondary|Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)||12 weeks|Per Protocol Set|||mg/dL||Standard Deviation|Mean
2630763|NCT01850602|Primary|Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment|Covariate: Serum phosphorus concentrations at baseline.|12 weeks|Per Protocol Set|||mg/dL||95% Confidence Interval|Mean
2630764|NCT01850589|Primary|Number of Participants With Smoking Cessation at 12 Months|Conservative vs. aggressive smoking strategies in treating smoking cessation.|12 months|Mean follow up was 7.3 months|||Participants|||Number
2630765|NCT01850550|Secondary|Dietary Intake|Assessed using the NCI Dietary History Questionnaire|12 weeks after initial consent|||||||
2630766|NCT01850550|Secondary|Physical Activity|Assessed by the International Physical Activity Questionnaire|12 weeks after initial consent|||||||
2630767|NCT01850550|Secondary|Blood Pressure|Blood pressure will be recorded using an OMRON automatic blood pressure cuff.|12 weeks after initial consent|||||||
2630768|NCT01850550|Secondary|BMI|Change in BMI from baseline to follow up will be assessed using a scale and stadiometer.|12 weeks after initial consent||||kg/m^2||Full Range|Mean
2630769|NCT01850550|Primary|Percent Change in Weight|We will assess our participants to evaluate the percent change in weight over the 12 week period of the study using a scale.|12 weeks after initial consent||||percent weight change||Full Range|Mean
2630770|NCT01850485|Secondary|SvO2|(venous oxygen saturation)|24 hours||||percent saturation||Standard Deviation|Mean
2630771|NCT01850485|Secondary|Lactate|lactate levels in serum|24 hours||||mmol/l||Standard Deviation|Mean
2630772|NCT01850485|Secondary|Cardiac Index|Cardiac Index is cardiac output indexed for body weight|24 hours||||L/m2||Standard Deviation|Mean
2630773|NCT01850485|Secondary|Inotropes and Vasopressor Dose||baseline||||mcg/kg/min||Inter-Quartile Range|Median
2630774|NCT01850485|Secondary|Fluid Balance After 24 Hours||24 hours||||liters||Standard Deviation|Mean
2630775|NCT01850485|Secondary|RincStO2|tissue oxygenation measured by Near Infrared Spectroscopy|baseline||||percent saturation||Standard Deviation|Mean
2630776|NCT01850485|Primary|Microvascular Flow Index (MFI)|Microvascular Flow Index; minimum score = 0 (= no flow) and maximum score = 3 (=normal flow)|baseline measurement||||units on a scale||Inter-Quartile Range|Median
2630777|NCT01850446|Secondary|Dynamics of Parameters of Immune Status (Relative Percentage of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).|The relative percentage of each type of white blood cells (WBC): Relative Count (AC) of leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and CD3, CD4, CD8, CD4/CD8, CD16, CD119 leukocytes.|On days 1, 3 and 7 of observation.|Intention to treat [ITT]|||Percentage of total white blood cells||Standard Deviation|Mean
2630778|NCT01850446|Secondary|Dynamics of Parameters of Immune Status (Absolute Number of Each Type of White Blood Cells and Different Lymphocyte Phenotypes).|The absolute number of each type of white blood cells (WBC): Absolut Count (AC) of leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and CD3, CD4, CD8, CD4/CD8, CD16, CD119 leukocytes.|On days 1, 3 and 7 of observation.|Intention to treat [ITT]|||10^9 cells/L||Standard Deviation|Mean
2630779|NCT01850446|Secondary|Dynamics of Parameters of Immune Status ( IFN-α and IFN-γ Production).|Level of spontaneous and induced production of IFN-α and IFN-γ (in vitro).|On day 1, 3 and 7 of observation.|Intention to treat [ITT]|||pg/mL||Standard Deviation|Mean
2633291|NCT01827163|Secondary|Participants Toxicity Evaluated While on Study Treatment|All toxicities following chemotherapy will be graded using the National Cancer Institute - Common Toxicity Criteria version 4.0.|1 year||||Participants|||Count of Participants
2630781|NCT01850446|Secondary|Proportion of Patients With Negative Results of Virological Analysis.|Based on medical records of patients whose nasopharyngeal swabs submitted for Reverse Transcription Polymerase Chain Reaction (RT-PCR) were negative for influenza A/B virus.|On days 3, 5, 7 of observation.|The number of patients to whom RT-PCR of the nasal samples was performed does not match the total number of patients in the ITT set due to the fact that not all nasopharyngeal samples were tested (due to violations of storage conditions in the centres before their transportation to the central laboratory).|||Participants|||Count of Participants
2630782|NCT01850446|Secondary|Percentage of Patients Requiring Antibiotics Administration.|"Based on patient's diary, objective examination (according to physician's objective examination).~The patients with the development of disease complications and exacerbation of the disease course (the development of severe influenza)."|On 1-7 days of observation.|Intention to treat [ITT]|||Participants|||Count of Participants
2630783|NCT01850446|Secondary|Percentage of Patients Who Used Antipyretics on Days 1, 2, 3, 4 and 5 of the Treatment.|"Antipyretics, which are allowed for use during clinical trial, are:~Paracetamol;~Metamizole sodium (if hyperthermia was not stopped by usage of paracetamol)."|Days 1, 2, 3, 4 and 5 of the treatment|Intention to treat|||Participants|||Count of Participants
2630784|NCT01850446|Secondary|The Severity of Influenza.|"Based on the patient diary. The severity of influenza based on the data on the Area Under Curve for total index of influenza severity."|On days 1-7 of the observation.|Intention to treat|||score*day||Standard Deviation|Mean
2630785|NCT01850446|Secondary|Duration of Clinical Symptoms of Influenza (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) in Days.|Duration of clinical symptoms of influenza (fever, non-specific symptoms and nasal/ throat/ chest symptoms) in days based on the result of the patient's diary data|On 1-7 days of observation|Intention to treat|||days||Standard Deviation|Mean
2630786|NCT01850446|Secondary|Severity of Influenza Symptoms (Fever, Flu Non-specific and Nasal/Throat/Chest Symptoms) in Scores According to the Symptoms Severity Scale.|"The symptoms severity scale includes 14 symptoms: body temperature, non-specific symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), nasal/throat/chest symptoms (runny nose, stuffy nose, sneezing, sore throat, hoarseness, cough, chest pain).~The severity of each non-specific and nasal/throat/chest symptom is scored on a 4-point scale (0=no symptom; 1=mild symptom; 2=moderate symptom; 3=severe symptom). The minimum value of each symptom is 0 points, and the maximum value is 4 points.~The absolute body temperature (in degrees Celsius) is converted to relative units (or scores) using the following scale: ≤37.2С=0 points; 37.3-38.0С=1 point; 38.1-39.0С=2 points; ≥39.1С=3 points.~The severity of symptoms is based on the physical examination of the patient by the physician on days 1, 3, and 7 and on the patient diary data on days 1-7. The minimum symptoms severity score is 0 points, the maximum score is 42 points."|On 1-7 days of observation|Intention to treat|||score on a scale||Standard Deviation|Mean
2630787|NCT01850446|Secondary|Percentage of Patients With Normal Body Temperature.|Based on patient's diary. Normal body temperature is no more than 37.0ºС.|Days 2-7 of the observation|Intention to treat (ITT)|||Participants|||Count of Participants
2630788|NCT01850446|Secondary|Average Duration of Fever.|Criteria of no fever - body temperature lower than 37.0° C for 24 hours|From the time of randomization until the time of recovery/improvement (days 1-7)|Intention to treat (ITT)|||days||Standard Error|Mean
2630789|NCT01850446|Secondary|Changes in Fever.|Fever changes over time (body temperature change on days 2-7 compared to baseline, based on patient diary data).|Baseline and days 2-7 of the observation|Intention to treat (ITT)|||°C||Standard Deviation|Mean
2630790|NCT01850446|Primary|Percentage of Patients With Recovery/Improvement in Health Status.|Based on days 2-7 days of observation according to the patient's diary, and on days 3 and 7 according to the physician's examination.|On 2-7 days of observation|Intention to treat [ITT]|||Participants|||Count of Participants
2630791|NCT01850394|Primary|Total Hemoglobin Loss|Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day|5 days after surgery|Use intention-to-treat analysis|||g/dL||Standard Deviation|Mean
2630792|NCT01850394|Secondary|Number of Patients Having Postoperative Complications|"Postoperative complications were measured as an incidence of the following complications;~wound hematoma~surgical site infection~systemic infection~deep vein thrombosis~pulmonary embolism~knee stiffness requiring manipulation~medical complication such as myocardial infarction, congestive hear failure"|postoperative 1-year period|Using Intention-to-treat analysis|||participants|||Number
2630793|NCT01850394|Secondary|Number of Patients Required Blood Transfusion||postoperative period (5 days after surgery)||||participants|||Number
2630794|NCT01850394|Secondary|Knee Function Scores|"Knee function score was measured with 2 methods, and were evaluated preoperatively and then postoperatively at 3-month, 6-month, and 1-year period.~Knee Society Knee Score using for rating knee function measurement and subdivided into two parts; knee score and function score 1.1. Knee score : calculated from pain, presence of deformity, total range of flexion, alignment, and stability. Total score is 100 (0-100), more score means better.~1.2. Function score : calculated from patient's ability to walk and climb stairs. The score ranges from 0-100, more score means better.~Western Ontario and McMaster Universities Arthritis Index or WOMAC score : a widely used, standardized questionnaires for evaluating the condition of patients with knee osteoarthritis, including pain (score = 0-20), stiffness (0-8), and functional limitation (0-68). Total score ranges from 0-68, lower score means better."|1 year after surgery|Using intention-to-treat analysis|||units on a scale||Standard Deviation|Mean
2630795|NCT01850394|Primary|Perioperative Blood Loss|"Drainage blood loss measured by accumulating total drainage volume postoperatively~Calculated total blood loss measured by using specific formula and difference between hematocrit preoperatively and the fourth postoperative day"|5 days after surgery|Using intention-to-treat analysis|||ml||Standard Deviation|Median
2630796|NCT01850030|Secondary|Gender of the Newborn|was recorded and collected for Newborn|After delivery (about 9 months after IVF)||||number of newborns|||Number
2630797|NCT01850030|Secondary|Percentage of Participants With a Successful Completion of Pregnancy|Incidence of live births and healthy newborns|After delivery (about 9 months after IVF)||||percentage of participants||95% Confidence Interval|Number
2631276|NCT01846221|Secondary|Neonatal Apgar Score|The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.|1 minute and 5 minutes post delivery||||Apgar score||Full Range|Mean
2630800|NCT01850004|Secondary|Progression Free Survival (PFS) Rate|Progression is defined as Transformation to Accelerated Phase or Blast Crisis (AP/BC) Accelerated Phase (AP) Blasts in PB or BM 15-29%; Blast + promyelocytes >= 30% with blasts < 30% or ACA in Ph+ cells (clonal progression), or basophils in blood >= 20%,or platelets < 100 x 109 /L unrelated to therapy Blastic Phase or Crisis (BP/BC) Blasts in PB or BM >= 30%, or extramedullary blast cell involvement (with the exception of spleen and liver)|From Dasatinib treatment discontinuation up to 5 years|All evaluable participants|||Percentage of participants||95% Confidence Interval|Number
2630801|NCT01850004|Secondary|Relapse-free Survival (RFS) After Dasatinib Discontinuation|Relapse is defined as any of the following events while a subject is on study: the loss of MMR, loss of Complete Cytogenetic Response (CCyR), loss of Complete Hematologic Response (CHR) or progression to advanced/blastic phase. RFS is defined as the time from Dasatinib treatment discontinuation to the date of relapse. Subjects who did not relapse were censored on the date of their last molecular assessment.|At 6,12,18, 24 months and every 6 months thereafter up to 5 years|All evaluable participants|||Percentage of Participants||95% Confidence Interval|Number
2630802|NCT01850004|Secondary|Event-free Survival (EFS) Rate After Dasatinib Discontinuation|EFS was defined as the time from the date of dasatinib treatment discontinuation to the date of loss of MMR.|At 12 months|All evaluable participants|||Percentage of participants||95% Confidence Interval|Number
2630803|NCT01850004|Primary|Major Molecular Response (MMR) Rate|Major Molecular Response (MMR) rate at 12 months is the percentage of participants who maintain MMR (BCR-ABL transcripts < 0.1% on the International Scale [IS]) at 12 months after Dasatinib discontinuation without restarting Dasatinib|At 12 months after Dasatinib discontinuation (assessed up to approximately June 4, 2018)|All evaluable participants|||Percentage of Participants||95% Confidence Interval|Number
2630804|NCT01849848|Secondary|Number of Abnormalities (Grade ≥3) in Laboratory Test Values|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild, grade 2 : moderate, grade 3 : severe or medically significant but not immediately life-threatening grade, 4 : life threatening or disabling grade, 5 : death related to adverse event|up to around 44 weeks||||Events|||Number
2630805|NCT01849848|Secondary|Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using Common Terminology Criteria for Adverse Events (CTCAE). grade 1 : mild, grade 2 : moderate, grade 3 : severe or medically significant but not immediately life-threatening grade, 4 : life threatening or disabling grade, 5 : death related to adverse event|up to around 44 weeks||||participants|||Number
2630806|NCT01849848|Secondary|Adverse Events|All adverse events occurring during the administration of the investigational product are to be examined for safety by cross tabulation lists and tables of incidence from the viewpoint of relationship with the drug, disease severity and medicine treated group.|up to around 44 weeks||||participants|||Number
2630807|NCT01849848|Secondary|Overall Survival (OS)|Using the registration date as the start date, OS with death, regardless of the cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.|up to around 44 weeks||||Days||95% Confidence Interval|Median
2630808|NCT01849848|Secondary|Duration of Response (DOR)|From initial response (PR or higher), DOR with relapse/recurrence or progression, and death, regardless of cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.|up to around 44 weeks||||Days||95% Confidence Interval|Median
2630809|NCT01849848|Secondary|Time to Treatment Failure (TTF)|Using the registration date as the start date, TTF with relapse/recurrence or progression, death regardless of the cause, and early discontinuation of treatment as events are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.|up to around 44 weeks||||Days||95% Confidence Interval|Median
2630810|NCT01849848|Secondary|Progression-Free Survival (PFS)|Using the registration date as the start date, PFS with relapse/recurrence or progression, and death regardless of the cause as events are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and the 95% confidence interval are to be calculated.|up to around 44 weeks||||Days||95% Confidence Interval|Median
2630811|NCT01849848|Secondary|Response Rate (CR+PR) Based on the Blade Criteria|"The criteria for PR based on the Blade are shown below.~PR requires 1. or all of the others:~Some, but not all, of the criteria for CR are fulfilled~≥50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks~Reduction in 24 h urinary light chain excretion either by ≥90% or to <200 mg, maintained for a minimum of 6 weeks~For patients with non-secretory myeloma only, ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy~≥50% reduction in the size of soft tissue plasmacytomas~No increase in size or number of lytic bone lesions"|up to around 44 weeks||||percentage of paticipants||95% Confidence Interval|Number
2630812|NCT01849848|Secondary|Complete Response (CR) Based on the Blade Criteria|"The criteria for CR based on the Blade are shown below.~CR requires all of the followings:~Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks~<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy~No increase in size or number of lytic bone lesions~Disappearance of soft tissue plasmacytomas"|up to around 44 weeks||||percentage of paticipants||95% Confidence Interval|Number
2630813|NCT01849848|Secondary|Response Rate (sCR+CR) Based on IMWG Criteria||up to around 44 weeks||||percentage of paticipants||95% Confidence Interval|Number
2630830|NCT01849692|Secondary|Change From Baseline in CSFT, Cohort 2|CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.|||microns||Standard Deviation|Mean
2631277|NCT01846221|Secondary|Maternal Heart Rate|Heart rate will be measured at different timepoints.|Baseline, 30 Minutes post epidural administration|48 out of 51 participants were included from the Fentanyl group due to 4 participants did not have heart rate taken at 30 minutes.|||beats per minute (BPM)||Full Range|Mean
2630814|NCT01849848|Primary|Response Rate [Stringent CR (sCR)+Complete Response (CR)+Very Good PR (VGPR)+Partial Response (PR)]Based on International Myeloma Working Group (IMWG) Criteria|"The criteria for sCR, CR, VGPR, and PR based on IMWG are shown below.~sCR: Fulfills CR criteria as well as all of the following conditions~Normal free light chain (FLC) ratio(κ/λ)~Disappearance of clonal cells in bone marrow by immunohistochemistry or immunofluorescence~CR: Fulfills all of the following criteria~Negative immunofixation of serum and urine M-protein~<5% plasma cells in bone marrow~Disappearance of any soft tissue plasmacytoma~VGPR: Fulfills at least one of the following criteria~Serum and urine M-protein detectable by immunofixation but not electrophoresis~≥90% reduction in serum M-protein and 24-hour M-protein excretion amount in urine <0.1 g/24 hour~PR: Fulfills the following criteria~≥50% reduction in serum M-protein, and ≥90% reduction in urine M-protein, urine M-protein excretion amount is reduced to < 0.2 g/24hours"|up to around 44 weeks||||percentage of paticipants||95% Confidence Interval|Number
2630815|NCT01849770|Secondary|Mean Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12||Week 3-12, post titration of study medication||||ratio||95% Confidence Interval|Number
2630816|NCT01849770|Secondary|Mean Pain Severity|"At the Baseline Visit, subjects will be asked to recount the maximum intensity experienced with a muscle cramp in the previous 24 hours and the maximum intensity experienced with a muscle cramp in the previous 30 days.~The visual analog scale (VAS) will be used to measures pain associated with muscle cramping. It will be used to measure muscle cramp intensity in this study. The scale rating is from 0-10; 0 equals no symptoms, 10 equals most severe symptoms.~Subject will be provided with a muscle cramp diary to record muscle cramp intensity at home, daily."|Weeks 3-12, post titration of study medication||||units on a scale||95% Confidence Interval|Mean
2630817|NCT01849770|Secondary|Maximal Pain Severity - Ratios for Comparisons of Doses for Weeks 3-12||Week 3-12, post titration of study medication||||ratio||95% Confidence Interval|Number
2630818|NCT01849770|Secondary|Cramp Frequency - Ratios for Comparisons of Doses for Weeks 3-12||Week 3-12, post titration of study medication||||ratio||95% Confidence Interval|Number
2630819|NCT01849770|Secondary|Maximal Pain Severity|"At the Baseline Visit, subjects will be asked to recount the maximum intensity experienced with a muscle cramp in the previous 24 hours and the maximum intensity experienced with a muscle cramp in the previous 30 days.~The visual analog scale (VAS) will be used to measures pain associated with muscle cramping. It will be used to measure muscle cramp intensity in this study. The scale rating is from 0-10; 0 equals no symptoms, 10 equals most severe symptoms.~Subject will be provided with a muscle cramp diary to record muscle cramp intensity at home, daily."|Weeks 3-12, post titration of study medication||||units on a scale||95% Confidence Interval|Mean
2630820|NCT01849770|Other Pre-specified|Change in Slow Vital Capacity (SVC) Score|The vital capacity (VC) (percent of predicted normal) will be determined, using the slow VC method. The SVC can be measured using conventional spirometers that have had a calibration check prior to subject testing. A printout from the spirometer of all SVC trials will be retained.|Week 0, Week 6, and Week 12 (or Early Termination Date)||||percent of predicted normal||95% Confidence Interval|Mean
2630821|NCT01849770|Other Pre-specified|Change in ALS Functional Rating Scale- Revised (ALSFRS-R) Score|The ALSFRS-R is a quickly administered (5 minutes) ordinal rating scale (ratings 0-4) used to determine subjects' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, was closely associated with quality of life measures, and predicted survival.|Week 0, Week 2, Week 6, Week 12 (or Early Termination Date), and Week 16||||scores on a scale||95% Confidence Interval|Mean
2630822|NCT01849770|Secondary|Mean Weekly Cramp Frequency||Week 3-12, post titration of study medication||||cramps/week||95% Confidence Interval|Mean
2630823|NCT01849770|Secondary|Mean Cerebrospinal Fluid (CSF)/Plasma Ratio|The concentrations of Mexiletine were measured in cerebrospinal fluid (CSF) and plasma.|Week 6 Visit (up to 6 hours post dose)||||ratio||Standard Deviation|Mean
2630824|NCT01849770|Secondary|Area Under the Concentration Time Curve (AUC) of Mexiletine in Plasma.|Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.|Week 6 Visit (up to 6 hours post dose)||||µg*hr/mL||Standard Deviation|Mean
2630825|NCT01849770|Secondary|Peak Plasma Concentration (Cmax) of Mexiletine|Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.|Week 6 Visit (pre-dose, hours 1, 2, 3, and 6 post-dose on Week 6)||||pg/mL||Standard Deviation|Mean
2630826|NCT01849770|Secondary|Trough Plasma Concentration (Cmin) of Mexiletine|Subjects will have blood drawn to assess mexiletine concentrations for pharmacokinetics (PK) at the Week 6 Visit.|Week 6 Visit (pre-dose, hours 1, 2, 3, and 6 post-dose on Week 6)||||pg/mL||Standard Deviation|Mean
2630827|NCT01849770|Primary|Percentage of Participants That Discontinued Study Drug|Information on adverse effects of mexiletine will be determined at each visit by direct questioning of the subjects, clinical examination, review of concomitant medications, vital signs and laboratory test results.|Screening, Baseline Visit Pre-Dose and Post-Dose, Weeks 2, 6, and 12, and at the Final Safety Visit, if a subject discontinues study drug early. Adverse Events will be assessed via telephone Weeks 1, 10, and 16.||||percentage of participants|||Number
2630828|NCT01849692|Secondary|Change From Baseline in CSFT, Cohort 4|CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.|||microns||Standard Deviation|Mean
2630829|NCT01849692|Secondary|Change From Baseline in CSFT, Cohort 3|CSFT was assessed by SD-OCT and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.|||microns||Standard Deviation|Mean
2630843|NCT01849497|Secondary|Percent Change From Baseline in LDL-C at Week 6||Baseline and Week 6|Full analysis set|||percent change||Standard Error|Least Squares Mean
2630831|NCT01849692|Secondary|Change From Baseline in CSFT, Cohort 1|CSFT was assessed by Spectral-Domain Optical Coherence Tomography (SD-OCT) and measured in microns. A decrease in CSFT indicates improvement. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.|||microns||Standard Deviation|Mean
2630832|NCT01849692|Secondary|Change From Baseline in BCVA, Cohort 4|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.|||letters||Standard Deviation|Mean
2630833|NCT01849692|Secondary|Change From Baseline in BCVA, Cohort 3|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.|||letters||Standard Deviation|Mean
2630834|NCT01849692|Secondary|Change From Baseline in BCVA, Cohort 2|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with LOCF imputation for missing values.|||letters||Standard Deviation|Mean
2630835|NCT01849692|Secondary|Change From Baseline in BCVA, Cohort 1|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly out of 70 letters on the chart. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 7, Day 14, Day 28, Day 42, Day 56|This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables, with last observation carried forward (LOCF) imputation for missing values.|||letters||Standard Deviation|Mean
2630836|NCT01849692|Primary|Percentage of Responders Based on CSFT and BCVA Outcomes at Day 14 and Day 28|"A subject was considered a responder if at least 3 out of the following 4 criteria were fulfilled in comparison to baseline:~Greater than or equal to 4 letter gain in BCVA at Day 14~Greater than or equal to 4 letter gain in BCVA at Day 28~Greater than or equal to 80 micron decrease in CSFT at Day 14~Greater than or equal to 80 micron decrease in CSFT at Day 28. BCVA was measured by the number of letters read out of a possible 70 letters on the ETDRS chart. One eye (study eye) contributed to the analysis."|Baseline, Day 14, Day 28|"This analysis population includes all subjects who were randomized, received the initial injection or infusion, and had a baseline value and at least 1 postbaseline measurement for the period up to Day 28 for the primary efficacy variables (BCVA and/or CSFT). Here, n is the number of subjects in each arm group."|||percentage of responders||90% Confidence Interval|Number
2630837|NCT01849588|Other Pre-specified|Decrease Alpha-fetoprotein(AFP) Level > 20% From the Baseline|The proportion of participants with a decrease of greater than 20% in AFP (alpha-fetoprotein) level between baseline and any subsequent measurement following treatment with sorafenib will be reported.|2 years|AFP levels were not available for one participant.|||Participants|||Count of Participants
2630838|NCT01849588|Secondary|Overall Survival|Overall survival is defined as the time period between enrollment and the date of death. Participants who are still alive at last contact will be censored at this date.|2 years||||months||Full Range|Mean
2630839|NCT01849588|Secondary|Time to Radiological Tumor Progression|Time to radiological tumor progression is defined as the time period between enrollment and the earlier of tumor progression and death. Participants who are alive and progression-free at the date of last contact will be censored at this date.|2 years|Study was terminated early due to slow accrual.|||months||Full Range|Mean
2630840|NCT01849588|Primary|Decline in HCV-RNA Level|Successful decline in HCV (hepatitis C virus)-RNA level, with success defined as a decrease of at least two logs of HCV-RNA between baseline and any subsequent measurement.|up to 2 years||||Participants|||Count of Participants
2630841|NCT01849562|Primary|Safety and Tolerability of 12 Weeks of Sovaprevir and 3102 in Combination With Ribavirin in Subjects With Chronic Hepatitis C Genotype 1 Viral Infection.|To determine safety and tolerability of 12 weeks of sovaprevir/ACH-0143102/RBV in subjects with chronic hepatitis C genotype 1, the following criteria will be used: the number of subjects with discontinuations due to AEs, treatment emergent G3/G4 AEs, treatment emergent G3/G4 laboratory abnormalities, clinically significant ECGs.|12 weeks|The analysis population for safety and tolerability was the safety population, defined as all randomized subjects who received at least one dose of study drug. For this study, the safety population and the FA set were the same.|||participants|||Number
2630842|NCT01849562|Primary|Incidence of Sustained Virologic Response 4 Weeks (SVR4) After the Completion of Treatment.|Incidence of SVR4 after the completion of dosing, reported as HCV RNA less than the lower limit of quantification (<LLOQ), in subjects who received active treatment (sovaprevir and ACH-0143102 in combination with ribavirin) as compared to those who received placebo.|Four weeks after the completion of treatment|The analysis population for SVR4 was the full analysis (FA) set, defined as all randomized subjects who received at least one dose of study drug and had at least one baseline/post HCV RNA assessment. For this study, the FA set and the safety population were the same.|||Percentage of Subjects with SVR4|||Number
2630844|NCT01849497|Primary|Percentage of Participants With Full Administration of Evolocumab at Both Weeks 2 and 4|Self-administration of evolocumab was assessed by a telephone interview at Weeks 2 and 4. Each participant was asked about all attempted injection(s) and if the injection was administered in part, full, or none at all.|Week 2 and Week 4|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2630845|NCT01849458|Secondary|Number of Study Participants With Re-tears|Assess re-tears of the repaired tendon using ultrasound imaging. The definition of a re-tear for the rate reported is any full thickness tear in a tendon that was repaired with the BioFiber Scaffold that is at least 80% of the size of the original tear.|12 Months||||Participants|||Count of Participants
2630846|NCT01849458|Secondary|Number of Study Participants With Re-tears|Assess re-tears of the repaired tendon using ultrasound imaging. The definition of a re-tear for the rate reported is any full thickness tear in a tendon that was repaired with the BioFiber Scaffold that is at least 80% of the size of the original tear.|6 Months||||Participants|||Count of Participants
2630847|NCT01849458|Secondary|Clinical Functional Outcome - WORC Index|Evaluate clinical functional outcome WORC Index. This is a quality-of-life measurement specific for rotator cuff disease based on 21 questions answered using visual analog scales. It is organized in 5 subscales: physical symptoms, sprots/recreation, work, lifestyle, and emotions. Each item has a possible score from 0-100 where higher scores represent a lower quality of life. The scores are summed up to a possible 2100 points. The total number of points is subtracted from 2100, divided by 2100, then multiplied by 100 to create a percentage. The final score is thus a percentage ranging from 0 to 100 with higher percentages indicating better quality of life.|12 Months||||Percentage of WORC Index||Standard Deviation|Mean
2630848|NCT01849458|Secondary|Clinical Functional Outcome - WORC Index|Evaluate clinical functional outcome WORC Index. This is a quality-of-life measurement specific for rotator cuff disease based on 21 questions answered using visual analog scales. It is organized in 5 subscales: physical symptoms, sprots/recreation, work, lifestyle, and emotions. Each item has a possible score from 0-100 where higher scores represent a lower quality of life. The scores are summed up to a possible 2100 points. The total number of points is subtracted from 2100, divided by 2100, then multiplied by 100 to create a percentage. The final score is thus a percentage ranging from 0 to 100 with higher percentages indicating better quality of life.|6 Months|One subject is missing data for this outcome measure thus a total of 49 subjects were analyzed in this section.|||Percentage of WORC Index||Standard Deviation|Mean
2630849|NCT01849458|Secondary|Clinical Functional Outcome - Adjusted Constant-Murley Score|Evaluate clinical functional outcome Adjusted Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.[1] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. A score of 0 is considered the worst outcome and 100 is considered the best outcome.|12 Month||||scores on a scale||Standard Deviation|Mean
2630850|NCT01849458|Secondary|Clinical Functional Outcome - Adjusted Constant-Murley Score|Evaluate clinical functional outcome Adjusted Constant-Murley Score. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient.[1] The Constant-Murley score was introduced to determine the functionality after the treatment of a shoulder injury. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function. A score of 0 is considered the worst outcome and 100 is considered the best outcome.|6 Months|50 Participants|||scores on a scale||Standard Deviation|Mean
2630851|NCT01849458|Primary|Number of Participants With Device Associated Adverse Events|"The primary objective is to report the number of participants with device associated adverse events.~Device associated adverse events are defined as adverse events that are classified as possibly or definitely related to the study product or procedure, or anticipated adverse events listed in the product's Instruction for Use regardless of relationship to the study device."|12 Months||||Participants|||Count of Participants
2630852|NCT01849419|Secondary|Motivation to Socialize (Placebo)|"Participants complete the social choice task following administration of MDMA or placebo during which they choose between spending time 1) talking with another person; 2) sitting quietly alone; or 3) solving word problems. Choices were rated on a scale of 1 to 10 (with 10 indicating the highest level of desire to engage in that activity). The main outcome measure was desire to socialize (i.e., rating of talking to another person)."|5 minutes during each session||||units on a scale||Standard Error|Mean
2630853|NCT01849419|Secondary|Motivation to Socialize (Oxytocin)|"Participants complete the social choice task following administration of MDMA or placebo during which they choose between spending time 1) talking with another person; 2) sitting quietly alone; or 3) solving word problems. Choices were rated on a scale of 1 to 10 (with 10 indicating the highest level of desire to engage in that activity). The main outcome measure was desire to socialize (i.e., rating of talking to another person)."|5 minutes during each session||||units on a scale||Standard Error|Mean
2630854|NCT01849419|Secondary|Motivation to Socialize (MDMA)|"Participants complete the social choice task following administration of MDMA or placebo during which they choose between spending time 1) talking with another person; 2) sitting quietly alone; or 3) solving word problems. Choices were rated on a scale of 1 to 10 (with 10 indicating the highest level of desire to engage in that activity). The main outcome measure was desire to socialize (i.e., rating of talking to another person)."|5 minutes during each session||||units on a scale||Standard Error|Mean
2630855|NCT01849419|Secondary|Cardiovascular Response to Placebo (Diastolic Blood Pressure)|Diastolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session||||mmHg||Standard Error|Mean
2633366|NCT01826422|Primary|Lean Mass|We observed changes in body composition such as total lean mass by Dual X-ray Absorptiometry (DXA).|At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.||||g/kg of body weight||Full Range|Mean
2630856|NCT01849419|Secondary|Cardiovascular Response to Oxytocin (Diastolic Blood Pressure)|Diastolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session||||mmHg||Standard Error|Mean
2630857|NCT01849419|Secondary|Cardiovascular Response to MDMA (Diastolic Blood Pressure)|Diastolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session||||mmHg||Standard Error|Mean
2630858|NCT01849419|Secondary|Cardiovascular Response to Placebo (Systolic Blood Pressure)|Systolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session||||mmHg||Standard Error|Mean
2630859|NCT01849419|Secondary|Cardiovascular Response to Oxytocin (Systolic Blood Pressure)|Systolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session||||mmHg||Standard Error|Mean
2630860|NCT01849419|Secondary|Cardiovascular Response to MDMA (Systolic Blood Pressure)|Systolic Blood Pressure (mmHg) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session||||mmHg||Standard Error|Mean
2630861|NCT01849419|Secondary|Cardiovascular Response to Placebo (Heart Rate)|Heart rate (bpm) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session||||bpm||Standard Error|Mean
2630862|NCT01849419|Secondary|Cardiovascular Response to Oxytocin (Heart Rate)|Heart rate (bpm) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session||||bpm||Standard Error|Mean
2630863|NCT01849419|Secondary|Cardiovascular Response to MDMA (Heart Rate)|Heart rate (bpm) was assessed before drug administration and repeatedly after drug administration for the each session. Results are presented as the mean response over the entire session calculated as change from baseline.|repeatedly during each session||||bpm||Standard Error|Mean
2630864|NCT01849419|Secondary|Subjective Response to Placebo (Ratings of 'Feel Sociable')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session||||units on a scale||Standard Error|Mean
2630865|NCT01849419|Secondary|Subjective Response to Oxytocin (Ratings of 'Feel Sociable')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session||||units on a scale||Standard Error|Mean
2630866|NCT01849419|Secondary|Subjective Response to MDMA (Ratings of 'Feel Sociable')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session||||units on a scale||Standard Error|Mean
2630867|NCT01849419|Secondary|Subjective Response to Placebo (Ratings of 'Feel High')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session||||units on a scale||Standard Error|Mean
2630868|NCT01849419|Secondary|Subjective Response to Oxytocin (Ratings of 'Feel High')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session||||units on a scale||Standard Error|Mean
2630869|NCT01849419|Secondary|Subjective Response to MDMA (Ratings of 'Feel High')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session||||units on a scale||Standard Error|Mean
2630870|NCT01849419|Secondary|Subjective Response to Placebo (Ratings of 'Feel Drug')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session||||units on a scale||Standard Error|Mean
2630882|NCT01849276|Other Pre-specified|Identical Immunoblotting|Identical immunoblotting studies may also be performed using blood samples taken prior to start of treatment.|At baseline prior to study treatment|The study was terminated early due to slow accrual. As a result no data was collected or analyzed for this outcome measure.||||||
2630871|NCT01849419|Secondary|Subjective Response to Oxytocin (Ratings of 'Feel Drug')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session||||units on a scale||Standard Error|Mean
2630872|NCT01849419|Secondary|Subjective Response to MDMA (Ratings of 'Feel Drug')|"Participants completed this visual analog questionnaire item during which participants selected a rating between 0 (Not at all) to 100 (Extremely). Participants completed this questionnaire item before drug administration and every 30 minutes after drug administration at each session for a total of 6 times. Results are presented as the mean response over the entire session calculated as change from baseline."|repeatedly during each session||||units on a scale||Standard Error|Mean
2630873|NCT01849419|Primary|Emotional Recognition (Placebo)|"Participants completed the Dynamic Emotional Identification Task, or DEIT (Wardle et al. 2012) following MDMA, oxytocin or placebo administration during which they identify emotional facial expressions presented on the screen. Participants completed this task once during each of the sessions.~In the DEIT, 10 actors performed angry, fearful, sad, and happy expressions, for a total of 40 sequences, which were presented in random order. Each sequence consisted of 50 frames progressing from 0 to 100% emotional intensity at 2% steps, producing a color video of an emotional expression developing. Participants were instructed to press the space bar as soon as you know what expression is being displayed. This ended the sequence and presented options of angry, fearful, sad, and happy.~Perception of expressions was quantified as the intensity (0-100 %) of the face when the participant pressed the space bar for correctly identified sequences."|15 minutes during each session||||percent intensity||Standard Error|Mean
2630874|NCT01849419|Primary|Emotional Recognition (Oxytocin)|"Participants completed the Dynamic Emotional Identification Task, or DEIT (Wardle et al. 2012) following MDMA, oxytocin or placebo administration during which they identify emotional facial expressions presented on the screen. Participants completed this task once during each of the sessions.~In the DEIT, 10 actors performed angry, fearful, sad, and happy expressions, for a total of 40 sequences, which were presented in random order. Each sequence consisted of 50 frames progressing from 0 to 100% emotional intensity at 2% steps, producing a color video of an emotional expression developing. Participants were instructed to press the space bar as soon as you know what expression is being displayed. This ended the sequence and presented options of angry, fearful, sad, and happy.~Perception of expressions was quantified as the intensity (0-100 %) of the face when the participant pressed the space bar for correctly identified sequences."|15 minutes during each session||||percent intensity||Standard Error|Mean
2630875|NCT01849419|Primary|Emotional Recognition (MDMA)|"Participants complete the Dynamic Emotional Identification Task, or DEIT (Wardle et al. 2012) following MDMA, oxytocin or placebo administration during which they identify emotional facial expressions presented on the screen. Participants completed this task once during each of the sessions.~In the DEIT, 10 actors performed angry, fearful, sad, and happy expressions, for a total of 40 sequences, which were presented in random order. Each sequence consisted of 50 frames progressing from 0 to 100% emotional intensity at 2% steps, producing a color video of an emotional expression developing. Participants were instructed to press the space bar as soon as you know what expression is being displayed. This ended the sequence and presented options of angry, fearful, sad, and happy.~Perception of expressions was quantified as the intensity (0-100 %) of the face when the participant pressed the space bar for correctly identified sequences."|15 minutes during each session||||percent intensity||Standard Error|Mean
2630876|NCT01849289|Secondary|Number of Treatment Emergent AEs (Adverse Events)|Treatment emergent events (after first trial product administration and no later than 7 days after last trial product administration)|On or after the first day of exposure to randomised trial drug (week 0) and no later than seven days after last exposure to randomised trial drug (week 27)|The SAS included all subjects receiving at least one dose of investigational product.|||number of events|||Number
2630877|NCT01849289|Secondary|Responder for HbA1c (Below 7.0%) at End of Trial Without Severe and Minor Hypoglycaemic Episodes|A responder for HbA1c without severe or confirmed hypoglycaemia is defined as a subject, who meets the HbA1c target at end of trial without treatment emergent severe or confirmed hypoglycaemia during the last 12 weeks of treatment or within 7 days from last treatment.|Week 26|The FAS included all randomised subjects.|||participants|||Number
2630878|NCT01849289|Secondary|Within-subject Variability as Measured by Coefficient of Variation (CV%) in Pre-breakfast SMPG (Self-measured Plasma Glucose)|Within subject Coefficient of variation(CV[%]) in pre-breakfast self measured plasma glucose for dose adjustment after 26 treatment weeks are displayed below.|Week 26|The FAS included all randomised subjects. Missing data were imputed using LOCF. For 2 subjects in the IDeg OD arm it was not possible to estimate CV(%) due to missing data.|||percentage||Standard Deviation|Mean
2630879|NCT01849289|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) (Analysed by Central Laboratory)|Change from baseline in FPG after 26 weeks of treatment.|Week 0, week 26|The FAS included all randomised subjects. LOCF values are presented for this endpoint. 7 subjects were not included in the analysis.|||mmol/L||Standard Deviation|Mean
2630880|NCT01849289|Secondary|Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed PG value of less than 3.1 mmol/L (56 mg/dL).Minor hypoglycaemic episode is defined as an episode with symptoms consistent with hypoglycaemia with confirmation by full blood glucose < 2.8 mmol/L (50 mg/dL), or PG < 3.1 mmol/L (56 mg/dL) and which is handled by the subject himself/herself or any asymptomatic full blood glucose value < 2.8 mmol/L (50 mg/dL) or PG value < 3.1 mmol/L (56 mg/dL).|On or after the first day of exposure to randomised trial drug (week 0) and no later than 7 days after last exposure to randomised trial drug (week 27)|The Safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2630881|NCT01849289|Primary|Change From Baseline in HbA1c (%) (Analysed by Central Laboratory)|Change from baseline in HbA1c (%) after 26 weeks of treatment.|Week 0, week 26|The FAS included all randomised subjects. Last Observation Carried Forward (LOCF) values were presented for this endpoint.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2630883|NCT01849276|Other Pre-specified|Immunoblotting|Bone marrow and/or blood samples taken prior to initiation of treatment will be used in Immunoblotting studies to observe enzyme and protein activity.|At baseline prior to study treatment|The study was terminated early due to slow accrual. As a result no data was collected or analyzed for this outcome measure.||||||
2630884|NCT01849276|Other Pre-specified|Bone Marrow and Blood Samples Will be Taken Prior to Study Treatment to Determine Number of Leukemic Progenitor Cells||At baseline prior to study treatment|The study was terminated early due to slow accrual. As a result no data was collected or analyzed for this outcome measure.||||||
2630885|NCT01849276|Secondary|Length of Remission|Patients will be followed-up with to determine Remission length which is defined as the time from attainment of remission to relapse of disease.|From date of remission of disease to date of relapse (maximum of 5 year follow-up)|The study was terminated early due to slow accrual. As a result no data was collected or analyzed for this outcome measure.||||||
2630886|NCT01849276|Secondary|Disease-free Survival|Evaluation of Disease-Free Survival will defined as the time from the initiation of study treatment until the time of disease relapse.|Every 3 months for 2 years, and then every 6 months for 5 years post-treatment|The study was terminated early due to slow accrual. As a result no data was collected or analyzed for this outcome measure.||||||
2630887|NCT01849276|Secondary|Overall Survival|Patients will be followed-up with from the initiation of study treatment until progression of disease or for up to 5 years, whichever comes first.|Every 3 months for 2 years, and then every 6 months for 5 years post-treatment|The study was terminated early due to slow accrual. As a result no data was collected or analyzed for this outcome measure.||||||
2630888|NCT01849276|Secondary|Remission Rate|Patients will be evaluated for remission status in response to therapy.|Every 3 months for 2 years, and then every 6 months for 5 years post-treatment|The study was terminated early due to slow accrual. As a result no data was collected or analyzed for this outcome measure.||||||
2630889|NCT01849276|Primary|Study Treatment Dose Toxicity Will be Evaluated by Measurement of Adverse Events Experienced While on Treatment|Determination of Dose Limiting Toxicity (DLT) as evidenced by adverse events due to toxicity from study treatment. If no DLT is observed, then 3 patients will be enrolled in the next dose escalated cohort. If one DLT is seen in the first 3 patients, then an additional 3 patients will be enrolled at the same dose cohort. If 0-1 in 6 patients experience a DLT this dose will be considered tolerable and the next dose escalated cohort with enroll 3 patients. If 2 or more in 6 patients experience a DLT, the maximum tolerated dose (MTD) will have been exceeded and the next cohort will enroll 3 patients at a reduced dose.|Checked daily during administration of cytarabine and at least 2x weekly following therapy until desired blood counts acheived (maximum 15 days)|The study was terminated early due to slow accrual, thus insufficient data was collected to be analysed.||||||
2630890|NCT01849276|Primary|Evaluate Toxicity by Assessing the Adverse Events of Metformin and Cytarabine|To determine the maximum tolerated dose (MTD) by assessing the adverse events of metformin in combination with cytarabine in evaluating toxicity. Assessments will occur daily during cytarabine administration and at least twice weekly following treatment until blood count recovery.|Checked daily during administration of cytarabine and at least 2x weekly following therapy until desired blood counts acheived (maximum 15 days)|Adverse events that were assessed to be either possibly or unlikely related to treatment on study (i.e. relationship between treatment and adverse event could not be ruled out)|||Adverse events related to treatment|||Number
2630891|NCT01849263|Secondary|Time to Treatment Failure|Time to treatment failure is defined as the time from registration to the date of treatment discontinuation due to any reason. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.|Time from registration to the date of treatment discontinuation due to any reason, assessed up to 5 years|All patients beginning protocol treatment were included in this endpoint analysis.|||months||95% Confidence Interval|Median
2630892|NCT01849263|Secondary|Time to Subsequent Treatment|Time to subsequent treatment is defined as the time from registration to the date of initiation of subsequent treatment for lymphoma. The distribution of time to subsequent treatment will be estimated using the method of Kaplan-Meier.|Time from registration to the date of initiation of subsequent treatment for lymphoma, assessed up to 5 years|All patients beginning protocol treatment were included in this endpoint analysis.|||months||95% Confidence Interval|Median
2630893|NCT01849263|Secondary|Time to Response|Time to response is defined for all evaluable patients who have achieved a confirmed response as the time from the date of registration to the date at which the patient's objective status is first noted to be a CR or PR.The median and 95% confidence interval will be calculated using the methods of Kaplan-Meier.|Time from the date of registration to the date at which the patient's objective status is first noted to be a CR or PR, assessed up to 5 years|All patients reporting a response during treatment are included in this analysis.|||months||95% Confidence Interval|Median
2630894|NCT01849263|Secondary|Progression-free Survival|Progression-Free Survival is defined as the time from registration to documented progression or death due to any cause, whichever occurs first. Estimated using the method of Kaplan-Meier.|Time from registration to progression or death due to any cause, assessed up to 5 years|All patients beginning protocol treatment are included in this endpoint.|||months||95% Confidence Interval|Median
2630895|NCT01849263|Secondary|Overall Survival|Overall Survival is defined as the time from registration to death due to any cause. Estimated using the method of Kaplan-Meier.|Assessed up to 5 years|All patients beginning protocol treatment are included in this endpoint.|||months||95% Confidence Interval|Median
2630896|NCT01849263|Secondary|Duration of Response|"Duration of response is defined as the time from first evidence of a response to the first documented time of progressive disease (PD). Response and Progression were assessed using the Cheson et al. Revised Response Criteria for Malignant Lymphoma. > > A CR is defined as the disappearance of all evidence of disease. A PR is defined as ≥ 50% decrease in the sum of the products of dimensions (SPD) of up to 6 largest dominant masses; no increase in size of other nodes and regression on CT, and no increase in size of liver/spleen.Estimated using the method of Kaplan-Meier. >~> Progressive Disease (PD) is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir."|Time from the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression is documented, assessed up to 5 years|All patients that reported a response during treatment are included in this analysis.|||months||95% Confidence Interval|Median
2630897|NCT01849263|Primary|Overall Response Rate|"Overall response rate defined as a partial response (PR) or complete response (CR) as the objective status at any time during treatment, evaluated using the Cheson et al. Revised Response Criteria for Malignant Lymphoma. Ninety-five percent binomial confidence intervals for the true success proportion will be calculated.~A CR is defined as the disappearance of all evidence of disease. A PR is defined as ≥ 50% decrease in the sum of the products of dimensions (SPD) of up to 6 largest dominant masses; no increase in size of other nodes and regression on CT, and no increase in size of liver/spleen."|Up to 5 years|All patients that began protocol treatment were included in this analysis.|||proportion of participants||95% Confidence Interval|Number
2630898|NCT01849172|Secondary|Number of Participants Who Used Other Treatment During Study|The number and percentage of patients who used other treatments will be compared between groups during weeks 1-8 and 9-32.|weeks 1-8; weeks 9-32|6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32|||Participants|||Count of Participants
2630899|NCT01849172|Secondary|Change From Baseline in Serum FSH/LH Level|The change from baseline in serum FSH/LH at weeks 8 and 20 equals FSH/LH at weeks 8 and 20 minus FSH/LH at baseline, respectively.|at baseline, weeks 8 and 20|FSH, LH, and FSH/LH values were missing in 9 participants in the electroacupuncture group and 8 participants in the sham electroacupuncture group at week 8, and in 16 participants in the electroacupuncture group and 14 participants in the sham electroacupuncture group at week 20.|||ratio||95% Confidence Interval|Mean
2630900|NCT01849172|Secondary|Change From Baseline in Serum LH Level|The change from baseline in serum LH level at weeks 8 and 20 equals LH at weeks 8 and 20 minus LH at baseline, respectively.|at baseline, and weeks 8 and 20|FSH, LH, and FSH/LH values were missing in 9 participants in the electroacupuncture group and 8 participants in the sham electroacupuncture group at week 8, and in 16 participants in the electroacupuncture group and 14 participants in the sham electroacupuncture group at week 20.|||mIU/ml||95% Confidence Interval|Mean
2630901|NCT01849172|Secondary|Change From Baseline in Serum E2 Level|The change from baseline in serum E2 level at weeks 8 and 20 equals E2 at weeks 8 and 20 minus E2 at baseline, respectively.|at baseline, and weeks 8 and 20|Estradiol values were missing in 37 participants in the electroacupuncture group and 39 participants in the sham electroacupuncture group at week 8, and in 44 patients in the electroacupuncture group and 38 participants in the sham electroacupuncture group at week 20.|||pmol/ml||95% Confidence Interval|Mean
2630902|NCT01849172|Secondary|Change From Baseline in Serum FSH Level|The change from baseline in serum FSH level at weeks 8 and 20 equals FSH at weeks 8 and 20 minus FSH at baseline, respectively.|at baseline, and weeks 8 and 20|FSH, LH, and FSH/LH values were missing in 9 participants in the electroacupuncture group and 8 participants in the sham electroacupuncture group at week 8, and in 16 participants in the electroacupuncture group and 14 participants in the sham electroacupuncture group at week 20.|||mIU/ml||95% Confidence Interval|Mean
2630903|NCT01849172|Secondary|Change From Baseline in the Sexual Functioning Domain of Menopause-Specific Quality of Life Questionnaire|"The change from baseline in the sexual functioning domain of Menopause-Specific Quality of Life Questionnaire (MENQOL) at weeks 4, 8, 20 and 32 equals the sexual functioning domain of MENQOL at weeks 4, 8, 20 and 32 minus the sexual functioning domain of MENQOL at baseline, respectively.~The sexual functioning domain contains 3 items (items 27-29). Each of the item scores ranges from 0 to 6. The vasomotor domain score will be calculated as the all sexual functioning items ranging from 0 to 18, with lower scores indicating a better quality of life."|at baseline, and weeks 4, 8, 20 and 32|6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32|||units on a scale||95% Confidence Interval|Mean
2630904|NCT01849172|Secondary|Change From Baseline in the Physical Domain of Menopause-Specific Quality of Life Questionnaire|"The change from baseline in the physical domain of Menopause-Specific Quality of Life Questionnaire (MENQOL) at weeks 4, 8, 20 and 32 equals the physical domain of MENQOL at weeks 4, 8, 20 and 32 minus the physical domain of MENQOL at baseline, respectively.~The physical domain contains 16 items (items 11-26). Each of the item scores ranges from 0 to 6. The vasomotor domain score will be calculated as the all physical items ranging from 0 to 96, with lower scores indicating a better quality of life."|at baseline, and weeks 4, 8, 20 and 32|6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32|||units on a scale||95% Confidence Interval|Mean
2630905|NCT01849172|Secondary|Change From Baseline in the Psychosocial Domain of Menopause-Specific Quality of Life Questionnaire|"The change from baseline in the psychosocial domain of Menopause-Specific Quality of Life Questionnaire (MENQOL) at weeks 4, 8, 20 and 32 equals the psychosocial domain of MENQOL at weeks 4, 8, 20 and 32 minus the psychosocial domain of MENQOL at baseline, respectively.~The psychosocial domain contains 7 items (items 4-10). Each of the item scores ranges from 0 to 6. The vasomotor domain score will be calculated as the all psychosocial items ranging from 0 to 42, with lower scores indicating a better quality of life."|at baseline, and weeks 4, 8, 20 and 32|6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32|||units on a scale||95% Confidence Interval|Mean
2630906|NCT01849172|Secondary|Change From Baseline in the Vasomotor Domain of Menopause-Specific Quality of Life Questionnaire|"The change from baseline in the vasomotor domain of Menopause-Specific Quality of Life Questionnaire (MENQOL) at weeks 4, 8, 20 and 32 equals the vasomotor domain of MENQOL at weeks 4, 8, 20 and 32 minus the vasomotor domain of MENQOL at baseline, respectively.~The vasomotor domain contains 3 items (items 1-3). Each of the item scores ranges from 0 to 6. The vasomotor domain score will be calculated as the all vasomotor items ranging from 0 to 18, with lower scores indicating a better quality of life."|at baseline, and weeks 4, 8, 20 and 32|6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32|||units on a scale||95% Confidence Interval|Mean
2630907|NCT01849172|Secondary|Change From Baseline in Menopause-Specific Quality of Life Questionnaire Total Score|"The change from baseline in Menopause-Specific Quality of Life Questionnaire (MENQOL) total score at weeks 4, 8, 20 and 32 equals the MENQOL total score at weeks 4, 8, 20 and 32 minus the MENQOL score at baseline, respectively.~It composed of 29 items and was divided into four domains: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). Each of the item scores ranges from 0 to 6. The total score will be calculated as the all items ranging from 0 to 174, with lower scores indicating a better quality of life."|at baseline, and weeks 4, 8, 20 and 32|6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32|||units on a scale||95% Confidence Interval|Mean
2630908|NCT01849172|Secondary|Change From Baseline in Mean 24-h Hot Flash Score|"The 24-h hot flash score was daily hot flash episodes multiplied by the corresponding severities. The change from baseline in mean 24-h HF score at weeks 4, 8, 20 and 32 equals the mean 24-h HF score at weeks 4 , 8, 20 and 32 minus the mean 24-h HF score at baseline, respectively.~Hot flashes score consisted the number and the degree of hot flashes. The hot flashes score is the sum of the scores of all the hot flashes occurring in a whole day, with a higher score indicating worse symptoms. A 3-point rating scale allows the women to describe the perceived severity of hot flash. 1 point = mild hot flash, 2 point = moderate hot flash, 3 point = severe hot flash."|at baseline, and weeks 4, 8, 20 and 32|6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32|||units on a scale||95% Confidence Interval|Mean
2630909|NCT01849172|Secondary|Change From Baseline in Urogenital Domain of Menopause Rating Scale|"The change from baseline in urogenital domain of Menopause Rating Scale(MRS) at weeks 4, 8, 20 and 32 equals the urogenital domain of MRS at weeks 4, 8, 20 and 32 minus the urogenital domain of MRS at baseline, respectively.~The urogenital domain contains 3 items (items 8-10). Each of the item scores ranges from 0 to 4. The psychological domain score will be calculated as the all urogenital items ranging from 0 to 12, with higher scores indicating worse symptoms."|at baseline, and weeks 4, 8, 20 and 32|6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32|||units on a scale||95% Confidence Interval|Mean
2630910|NCT01849172|Secondary|Change From Baseline in Psychological Domain of Menopause Rating Scale|"The change from baseline in psychological domain of Menopause Rating Scale(MRS) at weeks 4, 8, 20 and 32 equals the psychological domain of MRS at weeks 4, 8, 20 and 32 minus the psychological domain of MRS at baseline, respectively.~The psychological domain contains 4 items (items 4-7). Each of the item scores ranges from 0 to 4. The psychological domain score will be calculated as the all psychological items ranging from 0 to 16, with higher scores indicating worse symptoms."|at baseline, and weeks 4, 8, 20 and 32|6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32|||units on a scale||95% Confidence Interval|Mean
2630911|NCT01849172|Secondary|Change From Baseline in Somatic-vegetative Domain of Menopause Rating Scale|"The change from baseline in somatic-vegetative domain of Menopause Rating Scale(MRS) at weeks 4, 8, 20 and 32 equals the somatic-vegetative domain of MRS at weeks 4, 8, 20 and 32 minus the somatic-vegetative domain of MRS at baseline, respectively.~The somatic-vegetative domain contains 4 items (items 1-3 and 11). Each of the item scores ranges from 0 to 4. The somatic-vegetative domain score will be calculated as the all somatic-vegetative items ranging from 0 to 16, with higher scores indicating worse symptoms."|at baseline, and weeks 4, 8, 20 and 32|6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8. 7 participants in the electroacupuncture group and 6 participants in the sham electroacupuncture group were missing at week 20 and week 32|||units on a scale||95% Confidence Interval|Mean
2630912|NCT01849172|Secondary|Change From Baseline in Menopause Rating Scale Total Score|"The change in Menopause Rating Scale (MRS）total score compared with baseline at weeks 4, 20 and 32 equals MRS total score at weeks 4, 20 and 32 minus MRS total score at baseline,respectively.~MRS is a self-report questionnaire for evaluating the severity of menopausal symptoms in women, which contains 11 items. Each of the 11 symptoms contained a scoring scale from 0 (no complaints) to 4 (very severe symptoms). The total score will be calculated as the all items ranging from 0 to 44, with higher scores indicating worse symptoms. The MRS including 3 dimensions: psychological, somatic-vegetative, and urogenital."|at baseline，and weeks 4, 20 and 32|6 participants in the electroacupuncture group and 5 participants in the sham electroacupuncture group were missing at week 4 and week 8.|||units on a scale||95% Confidence Interval|Mean
2630913|NCT01849172|Primary|Change From Baseline in Menopause Rating Scale Total Score|"The change in menopause rating scale (MRS) total score compared with baseline at week 8 equals MRS total score at week 8 minus MRS total score at baseline.~MRS is a self-report questionnaire for evaluating the severity of menopausal symptoms in women, which contains 11 items. Each of the 11 symptoms contained a scoring scale from 0 (no complaints) to 4 (very severe symptoms). The total score will be calculated as the all items ranging from 0 to 44, with higher scores indicating worse symptoms. The MRS including 3 dimensions: psychological, somatic-vegetative, and urogenital."|at baseline and week 8||||units on a scale||95% Confidence Interval|Mean
2630914|NCT01849068|Secondary|Change in Protein Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions|"We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation).~We combined the results at the end of each placebo phase from both sequence (average and standard deviation)."|At the end of the two 12-week interventions (Week 12 and 24)|Data will never be analyzed because the mRNA expression of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA reductase are sufficient.||||||
2630915|NCT01849068|Secondary|Change in Intestinal Protein Levels of LDL Receptor Between the Two 12-week Interventions|"We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation).~We combined the results at the end of each placebo phase from both sequence (average and standard deviation)."|At the end of the two 12-week interventions (Week 12 and 24)|Data will never be analyzed because the mRNA expression of LDL receptor is sufficient.||||||
2630916|NCT01849068|Secondary|Change in Intestinal mRNA Expression Levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA Reductase Between the Two 12-week Interventions|"We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation).~We combined the results at the end of each placebo phase from both sequence (average and standard deviation)."|At the end of the two 12-week interventions (Week 12 and 24)||||#copies/100000 copies housekeeping gene||Standard Deviation|Mean
2630917|NCT01849068|Primary|Change in Intestinal mRNA Expression Levels of LDL Receptor Between the Two 12-week Interventions|"We combined the results at the end of each ezetimibe phase from both sequence (average and standard deviation).~We combined the results at the end of each placebo phase from both sequence (average and standard deviation)."|At the end of the two 12-week interventions (Week 12 and 24)||||#copies/100000 copies housekeeping gene||Standard Deviation|Mean
2630918|NCT01849055|Secondary|Change From Baseline to Day 27 in Blood Pressure (BP)|The Day 27 change from Day -1 was analyzed by using analysis of covariance (ANCOVA) with treatment as a fixed effect and baseline Day -1 as a covariate. The treatment mean, difference to placebo, and difference to celecoxib were output with corresponding 90% confidence intervals.|Baseline, Day 27|All randomized participants who received at least one dose of study treatment and had evaluable data.|||millimeters of mercury (mmHg)||90% Confidence Interval|Least Squares Mean
2630919|NCT01849055|Secondary|Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3023703||Post first dose on Day 1 through Day 28 (Time Frame: Day 1: -0.5, 1, 2, 4, 8, 12, 24 hours; Days 5, 12, 20: -0.5 hours; Day 28: -0.5, 1, 2, 4, 8, 12, 24 hours.)|All randomly assigned participants who received at least one dose of the study medication and had evaluable PK data.|||Hours||Full Range|Median
2630920|NCT01849055|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY3023703||Post first dose on Day 1 through Day 28 (Time Frame: Day 1: -0.5, 1, 2, 4, 8, 12, 24 hours; Days 5, 12, 20: -0.5 hours; Day 28: -0.5, 1, 2, 4, 8, 12, 24 hours.)|All randomized participants who received at least one dose of the study medication and had evaluable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2630921|NCT01849055|Secondary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve [AUC(0-24)] of LY3023703||Post-First Dose on Days 1-28 (Time Frame: Day 1: -0.5, 1, 2, 4, 8, 12, 24 hours; Days 5, 12, 20: -0.5 hours; Day 28: -0.5, 1, 2, 4, 8, 12, 24 hours.)|All randomized participants who received at least one dose of the study medication and had evaluable PK data.|||hours•nanogram/milliliter (hr•ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2630922|NCT01849055|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|A summary of serious and all other non-serious adverse events (AE), regardless of possible study drug relatedness, is located in the Reported Adverse Events module.|Baseline to Study Completion (up to 74 Days)|Randomized participants who reported an AE that met any of the serious criteria.|||Participants|||Count of Participants
2630923|NCT01848990|Secondary|Mean Times Per Week Participants Said They Were Eating to Avoid Going Low Due to Late Insulin Action|Participants were asked device handling questions to provide information about the impact of the Hylenex administration procedure on everyday life and to investigate perceptions of the overall efficacy and responsiveness of their insulin program.|Month 12|ITT Population. Only participants with available data were analyzed. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|||occurrences per week||Standard Deviation|Mean
2630924|NCT01848990|Secondary|Number of Participants With the Indicated Responses to the Device Handling Questions|Participants were asked device handling questions to provide information about the impact of the Hylenex administration procedure on everyday life and to investigate perceptions of the overall efficacy and responsiveness of their insulin program. Question 1: Achieve excellent post meal glucose control; Question 2: Insulin responds quickly when basal rate is changed; Question 3: Insulin responds quickly when correction bolus is given.|Month 12|ITT Population. Only participants with available data were analyzed. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|||Participants|||Count of Participants
2630925|NCT01848990|Secondary|Number of Participants With the Indicated Responses to the Question Regarding the Difficulty of Infusion Site Change|Participants were asked device handling questions to provide information about the impact of the Hylenex administration procedure on everyday life and to investigate perceptions of the overall efficacy and responsiveness of their insulin program.|Month 12|ITT Population. Only participants with available data were analyzed. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|||Participants|||Count of Participants
2630926|NCT01848990|Secondary|Mean Additional Time for Hylenex Pre-administration|Participants were asked device handling questions to provide information about the impact of the Hylenex administration procedure on everyday life and to investigate perceptions of the overall efficacy and responsiveness of their insulin program.|Month 12|ITT Population. Only participants with available data were analyzed. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|||minutes||Standard Deviation|Mean
2630927|NCT01848990|Secondary|Mean Time to Change Infusion Site|Participants were asked device handling questions to provide information about the impact of the Hylenex administration procedure on everyday life and to investigate perceptions of the overall efficacy and responsiveness of their insulin program.|Month 12|ITT Population. Only participants with available data were analyzed. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|||minutes||Standard Deviation|Mean
2631018|NCT01848184|Other Pre-specified|Summary of Risk Factors at Baseline|Summary of Risk factors at Baseline. Risk factors include: Smoker, Obesity, Diabetes T1 & T2, Cancer, Cardiovascular disease, Hypertension, COPD, Chronic desease requiring analgesic or corticoid consumption|Baseline|Number of patients with risk factors at baseline|||participants|||Number
2630928|NCT01848990|Secondary|Change From Baseline in DTSQs and DTSQc at Month 12|The Diabetes Treatment Satisfaction Questionnaire-status version (DTSQs) and DTSQ-change version (DTSQc) are validated tools to assess treatment satisfaction and change in treatment satisfaction after therapy changes have occurred. The scale total was computed by adding the 6 items (1, 4, 5, 6, 7, and 8) to produce the Treatment Satisfaction scale total, which has a minimum of 0 and a maximum of 36 on the DTSQs and a minimum of -18 and a maximum of 18 on the DTSQc. Higher scores represent greater satisfaction. If any of the 6 item scores were missing and the numbers of missing scores were less than the number of non-missing scores, the Treatment Satisfaction scale score was to be computed by taking the average of the existing scores and multiplying the average by 6. If there were less than 4 non-missing item scores, the Treatment Satisfaction scale score was not to be calculated. Baseline is defined as the last measurement prior to randomization.|Baseline; Month 12|ITT Population. Only participants with available data were analyzed. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|||score on a scale||Standard Error|Least Squares Mean
2630929|NCT01848990|Secondary|Change From Baseline in Average Weighted Impact ADDQoL Values at Month 12|The ADDQoL is a validated, diabetes-specific questionnaire to evaluate the participant's assessment of QoL. Participants rated the impact of diabetes on 19 applicable domains on a scale from -3 (maximum negative impact) to +3 (maximum positive impact) and then rated the importance of those domains for their QoL on a scale from 3 (very important) to 0 (not at all important). Impact ratings were multiplied by the corresponding importance ratings to provide a weighted-impact score for each domain from -9 (maximum negative impact) to +9 (maximum positive impact). Weighted impact scores were summed and divided by the number of applicable domains to give an overall Average Weighted Impact (AWI) score (higher values represent more positive impact). If there were less than 13 non-missing weighted-impact values, AWI was not to be calculated. Baseline is defined as the last measurement prior to randomization.|Baseline; Month 12|ITT Population. Only participants with available data were analyzed. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|||score on a scale||Standard Error|Least Squares Mean
2630930|NCT01848990|Secondary|Change From Baseline in Weighted Impact ADDQoL Values at Month 12|The Audit of Diabetes Dependent Quality of Life (ADDQoL) is a validated, diabetes-specific questionnaire to evaluate the participant's assessment of quality of life (QoL). Participants rated the impact of diabetes on 19 applicable domains on a scale from -3 (maximum negative impact) to +3 (maximum positive impact) and then rated the importance of those domains for their QoL on a scale from 3 (very important) to 0 (not at all important). Impact ratings were multiplied by the corresponding importance ratings to provide a weighted-impact score for each domain from -9 (maximum negative impact) to +9 (maximum positive impact).|Baseline; Month 12|ITT Population. Only participants with available data were analyzed. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|||score on a scale||Standard Error|Least Squares Mean
2630931|NCT01848990|Secondary|Area Per Day <56 mg/dL, ≤70 mg/dL, ≥140 mg/dL, Outside of 71 to 180 mg/dL, and Outside of 71 to 139 mg/dL|For each participant, the following continuous glucose monitoring (CGM) parameters were calculated using CGM values recorded after Randomization up to Month 12: area per day spent in the pre-defined glucose classes. The area per day for a specific glucose concentration range (e.g., <56 mg/dL) is the sum of the area under the curve with glucose concentration falling in the specific glucose concentration range (e.g., <56 mg/dL). For example, if the glucose stays constant at 50 mg/dL for the whole day (1,440 minutes), the area per day for glucose < 56 mg/dL equals: 50*1440 = 72,000 mg*minutes/dL.|Randomization to Month 12|ITT Population. Only participants with available data were analyzed. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|||mg*minutes/deciliter||Standard Error|Least Squares Mean
2630932|NCT01848990|Secondary|Time Per Day <56 Milligrams Per Deciliter (mg/dL), ≤70 mg/dL, >70 mg/dL, <140 mg/dL, ≥140 mg/dL, Outside of 71 to 180 mg/dL, and Outside of 71 to 139 mg/dL|For each participant, the following CGM parameters were calculated using CGM values recorded after Randomization up to Month 12: time per day spent in the pre-defined glucose classes.|Randomization to Month 12|ITT Population. Only participants with available data were analyzed. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|||minutes||Standard Error|Least Squares Mean
2630933|NCT01848990|Secondary|Average Glucose, Median Glucose, and Average Daily Standard Deviation|For each participant, the following continuous glucose monitoring (CGM) parameters were calculated using CGM values recorded after Randomization up to Month 12: average glucose, median glucose, and average daily standard deviation.|Randomization to Month 12|ITT Population. Only participants with available data were analyzed. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|||milliliters per deciliter||Standard Error|Least Squares Mean
2630934|NCT01848990|Secondary|Average of Bolus Times Relative to Meal Times|The average meal bolus timing relative to meal time is defined as the minutes between the start time of a meal bolus and the start time of a meal.|Month 1 to Month 12|ITT Population. Only participants with available data were analyzed. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|||minutes||Standard Deviation|Mean
2630935|NCT01848990|Secondary|Average Correction Factor (CorrF) Values|CorrF is calculated as 1960 / total daily dose of insulin (milligrams/[deciliter*unit]).|Month 1 to Month 12|ITT Population. Only participants with available data were analyzed. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|||milligrams/(deciliter*unit)||Standard Error|Least Squares Mean
2630936|NCT01848990|Secondary|Average Carbohydrate Factor (CarbF) Values|CarbF is calculated as 2.6 * weight (pounds) / total daily dose of insulin (grams per unit).|Month 1 to Month 12|ITT Population. Only participants with available data were analyzed. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|||grams per unit||Standard Error|Least Squares Mean
2630937|NCT01848990|Secondary|Average of Daily Insulin Doses (Bolus, Basal, and Total)|The daily bolus insulin dose is calculated as the daily prandial (occurring before a meal) insulin dose plus the daily corrective insulin dose. Cumulative basal dosage is to generally be within 40% to 60% of the total daily dose.|from Randomization up to Month 12|ITT Population. Only participants with available data were analyzed. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|||International units||Standard Error|Least Squares Mean
2630938|NCT01848990|Secondary|Change From Baseline in Body Weight to Month 12|Baseline is defined as the last measurement prior to randomization.|Baseline; Week 2; Months 1, 2, 3, 4, 6, 9, and 12|ITT Population. Only participants with available data were analyzed. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|||kilograms||Standard Deviation|Mean
2630939|NCT01848990|Secondary|Number of Participants Achieving HbA1c <7.0% and HbA1c ≤6.5% at Month 12|The number of participants achieving HbA1c goals of <7% and ≤6.5% was calculated.|Month 12|ITT Population. Only participants with available data were analyzed. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|||Participants|||Count of Participants
2630940|NCT01848990|Secondary|Standard Deviation of Self-Monitoring Blood Glucose Values at 12 Months|Standard deviation of self-monitoring blood glucose values was calculated based on measurements taken within 15 minutes before a meal, 1 month and up to 12 months after study drug administration. LS means were calculated from ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|After Month 1 up to Month 12|ITT Population. Only participants with available data were analyzed.|||mg/dL||Standard Error|Least Squares Mean
2630941|NCT01848990|Secondary|Standard Deviation of Self-Monitoring Blood Glucose Values at 6 Months|Standard deviation of self-monitoring blood glucose values was calculated based on measurements taken within 15 minutes before a meal, 1 month and up to 6 months after study drug administration. LS means were calculated from ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|After Month 1 up to Month 6|Primary SMBG Analysis Population. Only participants with available data were analyzed.|||mg/dL||Standard Error|Least Squares Mean
2630942|NCT01848990|Secondary|Mean Glucose Excursions at 12 Months|A 4-hour postprandial glucose excursion was measured for 3 meals after 1 month up to 12 months. For each of the 3 meals, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal (for measurements taken within 15 minutes before a meal). The average of all excursions is presented. LS means were calculated from ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|After Month 1 up to Month 12|ITT Population. Only participants with available data were analyzed.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2630943|NCT01848990|Secondary|Mean Glucose Excursions at 6 Months|A 4-hour postprandial glucose excursion was measured for 3 meals after 1 month up to 6 months. For each of the 3 meals, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal (for measurements taken within 15 minutes before a meal). The average of all excursions is presented. Least Squares (LS) means were calculated from ANOVA with treatment (Hylenex, standard rapid-acting insulin CSII) as a fixed effect. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|After Month 1 up to Month 6|Primary SMBG Analysis Population. Only participants with available data were analyzed.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2630944|NCT01848990|Secondary|Rates of Hyperglycemia Events to Month 12|Overall rates of hyperglycemia (defined as blood glucose >240 mg/dL and >300 mg/dL) were based on measurements after 1 month up to 12 months. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|After Month 1 up to Month 12|"ITT Population. Only participants with available data were analyzed. The Number Analyzed reflects the number of participants with at least one event."|||events per participant per month|||Number
2630945|NCT01848990|Secondary|Rates of Hyperglycemia Events to Month 6|Overall rates of hyperglycemia (defined as blood glucose >240 mg/dL and >300 mg/dL) were based on measurements after 1 month up to 6 months. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|After Month 1 up to Month 6|"Primary SMBG Analysis Population. Only participants with available data were analyzed. The Number Analyzed reflects the number of participants with at least one event."|||events per participant per month|||Number
2660060|NCT01584388|Secondary|Complete Remission at Any Timepoint|IgG4-RD RI = 0 at any point in the trial|12 months||||Participants|||Count of Participants
2630946|NCT01848990|Secondary|Rates of HEs to Month 12|Overall rates of hypoglycemia (defined as blood glucose ≤70 milligrams per deciliter [mg/dL] and <56 mg/dL) were based on measurements after 1 month up to 12 months. A severe HE was classified as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. A nocturnal HE was classified as an event with a blood glucose of ≤70 mg/dL with start time between 2300 and 0600, inclusive. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|After Month 1 up to Month 12|"ITT Population. Only participants with available data were analyzed. The Number Analyzed reflects the number of participants with at least one event."|||events per participant per month|||Number
2630947|NCT01848990|Secondary|Rates of Hypoglycemia Events (HE) to Month 6|Overall rates of hypoglycemia (defined as blood glucose ≤70 milligrams per deciliter [mg/dL] and <56 mg/dL) were based on measurements after 1 month up to 6 months. A severe HE was classified as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. A nocturnal HE was classified as an event with a blood glucose of ≤70 mg/dL with start time between 2300 and 0600, inclusive. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|After Month 1 up to Month 6|"Primary Self-Monitoring of Blood Glucose (SMBG) Analysis Population: all randomized participants who received study treatment and had SMBG data up to Month 6. Only participants with available data were analyzed. The Number Analyzed reflects the number of participants with at least one event."|||events per participant per month|||Number
2630948|NCT01848990|Primary|Change From Baseline to 12 Months in HbA1c|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; 12 Months|Intent-to-Treat (ITT) Population: all randomized participants (par.). Comparisons were made by pooling all rHuPH20 pretreatment par. (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis. Only par. with available data were analyzed.|||percentage of HbA1c||Standard Deviation|Mean
2630949|NCT01848990|Primary|Change From Baseline to 6 Months in Glycosylated Hemoglobin (HbA1c)|Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; 6 Months|Participants who received at least one dose of study drug and had evaluable HbA1c data. Comparisons were made by pooling all of the rHuPH20 pretreatment participants (including both Formulations 1 and 2) and comparing against the standard CSII treatment arm. Formulation 1 versus Formulation 2 was compared as a supportive analysis.|||percentage of HbA1c||Standard Deviation|Mean
2630950|NCT01848977|Primary|Sum of Tissue Oxygenation Value Which Above Basline Value After Reperfusion Period Until Basline Value Was Achieved|During vascular occlusion test, the changes of StO2 and SrO2 values can divided into 3 epoch; Desaturation, Reoxygenation and Reactive hyperemia. After data collection, the rate of desaturation and reoxygenation were calculated.|Until basline tissue oxygenation value was achieved||||%*min||Standard Deviation|Mean
2630951|NCT01848977|Secondary|Baseline, Miminum and Maximum Tissue Oxygenation Value Measured by INVOS® (SrO2) Until Basline Value Was Achieved|Before VOT. basline StO2 and SrO2 were recorded and compared each other. During VOT, minimum/maximum StO2 and SrO2 were also recorded and compared each other.|Until basline tissue oxygenation value was achieved||||percentage of oxyhemoglobin||Standard Deviation|Mean
2630952|NCT01848977|Primary|Change of Tissue Oxygenation Value During Ischemia and Reperfusion Period Until Basline Value Was Achieved|During vascular occlusion test, the changes of StO2 and SrO2 values can divided into 3 epoch; Desaturation, Reoxygenation and Reactive hyperemia. After data collection, the rate of desaturation and reoxygenation were calculated.|Until basline tissue oxygenation value was achieved||||%/min||Standard Deviation|Mean
2630953|NCT01848938|Secondary|Patient`s Global Impression of Improvement Scale (PGI-I)|"A self-rated question that asks about the change experienced after treatment with 7 response options, ranging from very much better to very much worse."|three months|intention-to-treat analysis. Missing values at follow-up were replaced with a neutral value (i.e., no change).|||participants|||Number
2630954|NCT01848938|Secondary|Incontinence Episode Frequency (IEF)|number of incontinence episodes per week|baseline, three months|intention-to-treat analysis. Missing values at follow-up were replaced with the corresponding values at baseline (i.e., no change).|||episodes per week||Inter-Quartile Range|Median
2630955|NCT01848938|Secondary|Patient Satisfaction|A self-rated question about if the current treatment was sufficient, with three response options|three months|Data for this outcome measure could only be collected for the smartphone treatment group.|||participants|||Number
2630956|NCT01848938|Secondary|Usage of Incontinence Aids|Usage of incontinence aids during the last 4 weeks.|three months|intention-to-treat analysis. Missing values at follow-up were replaced with the corresponding values at baseline (i.e., no change).|||participants|||Number
2630957|NCT01848938|Primary|International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)|The instrument includes 19 items on the impact of the leakage. All items are scored 1-4 (not at all/never, slightly/sometimes, moderately/often, a lot/all the time). The overall score is 19-76, with higher values indicating increased impact on QOL.|baseline, three months|intention-to-treat analysis|||units on a scale||Standard Deviation|Mean
2630958|NCT01848938|Primary|International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)|Three items on frequency, amount of leakage and overall impact. Scoring 0-21, higher values indicating increasing severity|baseline, three months|intention-to-treat analysis|||units on a scale||Standard Deviation|Mean
2631019|NCT01848184|Other Pre-specified|Pain Score at Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months|Pain evaluation as determined by a 10-point pain intensity numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain). Scores reported at Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months|Various (Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months)|The number analyzed includes participants who completed the NRS pain scale|||units on a scale||Standard Deviation|Mean
2630959|NCT01848899|Primary|Thrombin Generation Test: After Coronary Angiography|The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus.|1 hour|A valid thrombogram was generated post-diagnostic angiography in 43/50 participants in the Ioxaglate arm and 37/50 participants in the Iodixanol arm. Thus, not all 100 participants were able to be included in analysis.|||nM*minutes||Inter-Quartile Range|Median
2630960|NCT01848899|Secondary|Percent Change in Maximal Platelet Aggregation: ADP|Percent change in maximal platelet aggregation from pre- to post-contrast in response to 20 μM of ADP|1 hour|Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure.|||Percent change||Inter-Quartile Range|Median
2630961|NCT01848899|Secondary|Percent Change in Maximal Platelet Aggregation: Arachidonic Acid|Percent change in maximal platelet aggregation from pre- to post-contrast in response to 1600 μM arachidonic acid|1 hour|Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure.|||Percent change||Inter-Quartile Range|Median
2630962|NCT01848899|Secondary|Percent Change in Maximal Platelet Aggregation: Epinephrine|Percent change in maximal platelet aggregation from pre- to post-contrast in response to 10 μM epinephrine|Baseline to 1 hour|Sufficient volumes of blood were not available for all participants to perform the analyses required for some secondary outcomes. Thus, not all 100 participants are included in this outcome measure.|||Percent change||Inter-Quartile Range|Median
2630963|NCT01848899|Primary|Thrombin Generation Test: Baseline|The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus.|baseline|A valid thrombogram was generated post-diagnostic angiography in 43/50 participants in the Ioxaglate arm and 37/50 participants in the Iodixanol arm. Thus, not all 100 participants were able to be included in analysis.|||nM*minutes||Inter-Quartile Range|Median
2630964|NCT01848847|Primary|Pain Scoring(VAS)|Pain scoring was made by 10 cm visual analog scale. pain score (recorded by the patient on a 10 -point visual analog scale (VAS) which means pain increases with increasing number|2 months||||units on a scale||Standard Deviation|Mean
2630965|NCT01848847|Secondary|Procedure Duration|Procedural time which will be measured in minutes|two months|||||||
2630966|NCT01848847|Secondary|Patient Acceptability and Pain Scoring|Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale.|two months|||||||
2630967|NCT01848847|Primary|Ease of Cervical Entry|Ease of cervical entry which will be assessed by Likert scale.The outcome measures in this study were the ease of cervical entry (judged by the individual surgeons using a 5-point Likert scale: very difficult= 1, difficult= 2, fair = 3, easy= 4, and very easy = 5.|2 months||||units on a scale||Standard Deviation|Mean
2630968|NCT01848834|Other Pre-specified|Number of Participants With Log Fold Change From Baseline in Cytokines (Interleukin 10 [IL-10]) >1|IL-10 is an anti-inflammatory cytokine. The number of participants with a log fold change from Baseline in IL-10 >1 was to be presented. Protocol Amendment 03 (26 May 2015) removed the secondary objective of investigating the relationship between programmed cell death 1 (PD-1) inhibition and up-regulation of cytokines biomarkers predicting response (e.g. IL-10) from the protocol. No data were collected for this outcome measure.|Baseline and Week 8|The population was to consist of all randomized participants who: 1) received ≥1 dose of study treatment and 2) had a baseline IL-10 assessment, and 3) had a post baseline IL-10 assessment. No data were collected for this outcome measure.||||||
2630969|NCT01848834|Secondary|Overall RECIST 1.1 Response Rate Based on Investigator Assessment for Cohort B2|ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed by Investigator evaluation. The percentages of participants who experienced a CR or PR in Cohorts A, B, C and D based on Investigator assessment are presented. ORR per Investigator assessment is presented for the other cohorts in a separate outcome measure.|Every 8 weeks until disease progression (Up to approximately 14 months)|The population consisted of all Cohort B2 participants who received ≥1 dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2630970|NCT01848834|Secondary|Overall RECIST 1.1 Response Rate Based on Investigator Assessment for Cohorts A, B, C and D|ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed by Investigator evaluation. The percentages of participants who experienced a CR or PR in Cohorts A, B, C and D based on Investigator assessment are presented. ORR per Investigator assessment is presented for Cohort B2 in a separate outcome measure.|Every 8 weeks until disease progression (Up to approximately 34 months)|The population consisted of all Cohort A, B, C and D participants who received ≥1 dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2630971|NCT01848834|Secondary|Overall RECIST 1.1 Response Rate Based on BICR Review, for Participants Previously Treated With Cetuximab and Platinum in Cohorts B and B2|ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who were previously treated with cetuximab and platinum and experienced a CR or PR in the Cohorts B and B2 is presented. ORR per RESIST 1.1 based on BICR review is presented for the other cohorts in separate outcome measures.|Every 8 weeks until disease progression (Up to approximately 27 months)|The population consisted of all Cohort B or B2 participants who progressed following cetuximab and platinum therapy and received ≥1 dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2631020|NCT01848184|Secondary|Recurrence Rate at 1, 6 and 12 Month Follow‐up|The number of participants with hernia recurrence at 1 month, 6 month and 12 month follow-up visit.|1, 6 and 12 month follow‐up.|The number analyzed reflects the number of participants who returned for 1 month, 6 month and 12 month follow-up visits.|||Participants|||Count of Participants
2630972|NCT01848834|Secondary|Overall RECIST 1.1 Response Rate Based on BICR Review, Cohort D Asia-Pacific (AP) Participants|ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who were from the Asia Pacific region and experienced a CR or PR in Cohort D is presented. ORR per RESIST 1.1 based on BICR review is presented for the other cohorts in separate outcome measures.|Every 8 weeks until disease progression (Up to approximately 30 months)|The population consisted of all Cohort D AP participants who received ≥1 dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2630973|NCT01848834|Secondary|Overall RECIST 1.1 Response Rate Based on BICR Review, Cohorts B and B2 HPV-positive Participants|ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who had tumors which were HPV positive and who experienced a CR or PR in the combined Cohorts B2 and B2 is presented. ORR per RESIST 1.1 based on BICR review is presented for the other cohorts in a separate outcome measure.|Every 8 weeks until disease progression (Up to approximately 27 months)|The population consisted of all Cohort B and Cohort B2 HPV-positive participants who received ≥1 dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2630974|NCT01848834|Primary|Overall RECIST 1.1 Response Rate Based on BICR Review for Participants in Cohort B2|ORR was defined as the percentage of participants in the analysis population who experienced a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentage of participants who experienced a CR or PR in Cohort B2 is presented. ORR per RESIST 1.1 based on BICR review is presented for the other cohorts in a separate outcome measure.|Every 8 weeks until disease progression (Up to approximately 14 months)|The population consisted of all Cohort B2 participants who received ≥1 dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2630975|NCT01848834|Primary|Overall Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Response Rate Based on Blinded Independent Central Radiology (BICR) Review (Cohorts A, B & B2, C, and D)|Overall Response Rate (ORR) was defined as the percentage of participants who experienced a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. The percentages of participants who experienced a CR or PR for Cohort A, Cohorts B and B2 participants, Cohort C and Cohort D are presented. Cohorts A, B, C and D enrolled participants with programmed cell death-ligand 1 (PD-L1) positive tumors; Cohort B2 enrolled participants regardless of PD-L1 expression.|Every 8 weeks until disease progression (Up to approximately 34 months)|The population consisted of all Cohort A, B, B2, C and D participants who received ≥1 dose of study treatment.|||Percentage of Participants||95% Confidence Interval|Number
2630976|NCT01848834|Primary|Number of Participants Discontinuing From Study Treatment Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented. Some cases of clinical progression that led to discontinuation of study treatment were captured as AEs that led to discontinuation of study treatment.|Up to last dose of study treatment (Up to approximately 31 months)|The population consisted of all participants who received ≥1 dose of study treatment.|||Participants|||Number
2630977|NCT01848834|Primary|Number of Participants Experiencing Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented.|Serious AEs: Up to 90 days after last dose of study treatment (Up to 34 months); nonserious AEs: Up to 30 days after last dose of study treatment (Up to 32 months)|The population consisted of all participants who received ≥1 dose of study treatment.|||Participants|||Number
2630978|NCT01848821|Secondary|Change in Histological Repair Score From Baseline to Skin Grafting Procedure|"At baseline and at every dressing change up to the skin grafting procedure, tissue biopsies for histopathological evaluation are obtained using a disposable dermal biopsy punch (8-mm diameter) or scalpel and locations of the biopsy sites within the wound are systematically rotated.~Parameters of tissue repair (fibroblast proliferation, collagen density, and neovascularization) were semiquantitatively assessed using a scoring system as follows: 0, none/minima; 1, mild; 2, moderate; 3, marked. Each parameter was assigned a score for a total minimum and maximum possible score of 0 and 9. A higher score represents more advanced wound healing."|Baseline, final Skin Grafting procedure||||Histological Repair Score|wound halves|Inter-Quartile Range|Median
2630979|NCT01848821|Secondary|Change in Histological Acute Inflammation Score From Baseline to Skin Grafting Procedure|"At baseline and at every dressing change up to the skin grafting procedure, tissue biopsies for histopathological evaluation are obtained using a disposable dermal biopsy punch (8-mm diameter) or scalpel and locations of the biopsy sites within the wound are systematically rotated.~Only biopsies from the Baseline and Final Skin Grafting Procedure are used to calculate this outcome measure.~Parameters of acute inflammation (polymorphonuclear neutrophil infiltrate, edema, hemorrhage, and necrosis) were semiquantitatively assessed using a scoring system as follows: 0, non/minimal; 1, mild; 2, moderate, 3, marked. Each parameter was assigned a score, for a minimum and maximum total possible score of 0 and 12. A higher score represents a higher degree of acute inflammation."|Baseline, Final Skin Grafting Procedure||||Histolotical Acute Inflammation Score|wound halves|Inter-Quartile Range|Median
2630980|NCT01848821|Primary|Change in Wound Size From Baseline to Final Wound Evaluation up to 60 Days Later|High-resolution digital photographs of the wound are taken (with a measurement scale included in the picture) at baseline and during serial wound evaluations in the operating room, at the bedside, and in the clinic. The picture is then uploaded into a wound tracing software program (Analyzing Digital images, www.umassk12.net/adki/) and wound area is calculated. Only the Baseline Measure and Final Wound Evaluation are used to calculate the Primary Outcome.|Baseline, Final Wound Evaluation up to 60 Days Later||||cm^2|wound halves|Inter-Quartile Range|Median
2630981|NCT01848756|Secondary|Adverse Events by Severity and Relationship to Treatment|Number of patients experiencing adverse events by highest recorded severity and relationship to study tretament|Every 28 day cycle|All treated subjects|||participants|||Number
2630982|NCT01848756|Secondary|Ophthalmologic Changes From Baseline|Ophthalmologic assessments will be presented by cohort, study visit and dose. Number of subjects experiencing clinically relevant changes from baseline in any of these examinations will be presented using descriptive summary|Screening, end of Cycle 1, final visit|ll Treated Subjects|||participants|||Number
2630983|NCT01848756|Secondary|Changes in Vital Signs, Physical Examination or Clinical Laboratory From Baseline|Descriptive summaries of vital signs, physical examination and clinical laboratory changes will be presented by treatment received.|Day 28 of each cycle|All Treated Subjects|||participants|||Number
2630984|NCT01848756|Secondary|Number of Patients With Adverse Events|Number of patients experiencing treatment emergent adverse events.|Day 28 of each cycle|All Treated Subjects|||participants|||Number
2630985|NCT01848756|Primary|Overall Survival|Time from start of treatment that patients remain alive.|Every 3 months until 24 months after the last subject has been enrolled|Due to slow recruitment and availability newer targeted treatments the study was terminated for business reasons. No patient completed 3 months on study, the first analysis time point for this endpoint, at the time of study termination||||||
2630986|NCT01848756|Primary|Progression Free Survival|Time on treatment with at worst stable disease.|Every 3 months until 24 months after the last subject has been enrolled|Due to slow recruitment and availability newer targeted treatments the study was terminated for business reasons. No patient completed 3 months on study, the first analysis time point for this endpoint, at the time of study termination||||||
2630987|NCT01848756|Primary|Objective Response Rate|The effect of SNX-5422 on tumor progression. Objective tumor responses (complete remissions plus partial remissions) and clinical benefit rate (complete remissions plus partial remissions plus stable disease at 6 months) will be listed by subject. Tumor measurements made using Response Evaluation Criteria in Solid Tumors (RECIST).|Up to 24 months from last patient entry|Per protocol population including all enrolled evaluable subjects.Due to slow recruitment and availability newer targeted treatments the study was terminated for business reasons. No patient completed 6 months on study, the first analysis time point for this endpoint, at the time of study termination||||||
2630988|NCT01848483|Secondary|Change in Self-reported Completion of Advanced Care Planning Activities: Living Will|"The Advanced Care Planning Questionnaire contained questions about 5 aspects of advanced care planning: 1) advanced care planning decisions made; 2) how well informed a participant feels about medical decision makers and making decisions; 3) how much a person has thought about medical decision making; 4) one's perceived confidence to make medical decisions; 5) one's readiness to make medical decisions. The results focus on decisions made regarding signing papers for either advance directives or living will (yes/no). Results are reported as the number of patients who report yes."|Baseline, 6 months post-baseline, and 12-months post baseline|Participants analyzed in each time point include the ones that were able to complete the questionnaire.|||Participants|||Count of Participants
2630989|NCT01848483|Secondary|Change in Self-reported Completion of Advanced Care Planning Activities: Health Care Decision Maker|"The Advanced Care Planning Questionnaire contained questions about 5 aspects of advanced care planning: 1) advanced care planning decisions made; 2) how well informed a participant feels about medical decision makers and making decisions; 3) how much a person has thought about medical decision making; 4) one's perceived confidence to make medical decisions; 5) one's readiness to make medical decisions. The results focus on decisions made regarding signing papers that name a health care decision maker (yes/no). Results are reported as the number of patients who report yes."|Baseline, 6 months post-baseline, and 12-months post baseline|Participants analyzed in each time point include the ones that were able to complete the questionnaire.|||Participants|||Count of Participants
2630990|NCT01848483|Secondary|Clinical Indicator: Change in Self-report Hospitalizations|Participants completed a survey asking about hospitalizations for HIV related problems and non-HIV related health problems in the past 3 months.Results are expressed in number of participants reporting a hospital stay in the previous 3 months.|Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline|Participants analyzed in each time point include the ones that were able to complete the survey.|||Participants|||Count of Participants
2630991|NCT01848483|Secondary|Clinical Indicator: Change in Mortality at 12 Months Post-baseline|Number of deaths at 12 months post baseline|Baseline, up to 12 months post- baseline||||Participants|||Count of Participants
2630992|NCT01848483|Primary|Change in Quality of Life|Change in Quality of Life (QOL) as measured by the McGill Quality of Life Questionnaire (MQOL) The MQOL has been widely used with persons with a life-threatening illness, including HIV/AIDS. It contains questions about physical wellbeing, physical symptoms, psychological symptoms, existential wellbeing and support in the past 2 days.A total score was computed.Scores range from 0 to 10 with higher scores indicating better perceived quality of life.|Baseline, 3 month post-baseline, 6 month post-baseline, 12 months post-baseline|Only included participants that were able to complete the McGill Quality of Life Questionnaire at each visit.|||score on a scale||Standard Deviation|Mean
2630993|NCT01848457|Secondary|Ototoxicity|Average hearing level (HL) threshold in decibels (dB) over the frequency range of 4,000-8,000 hertz (Hz) will be derived separately for each ear from audiograms performed before each dose of cisplatin.|Baseline (Week 1), Day 1 of Cycle 1 (Week 1), Day 1 of Cycle 2(Week 6), Day 1 of Cycle 3(Week 11), Day 1 of Cycle 4 (Week 16), and end of therapy/after the end of cycle 6 (Day 28 of cycle 6, Week 28)||||decibels||Full Range|Mean
2631021|NCT01848184|Primary|Primary Hernia Recurrence Rate at 24 Month Follow‐up.|The number of participants with hernia recurrence at 24 months, assessed during a physical examination and by ultrasonography.|24 month follow‐up|101 patients returned for 24 month Follow-Up Visit.|||Participants|||Count of Participants
2630994|NCT01848457|Secondary|Patient Reported Outcome Survey (PROS)|PROS survey measures quality of life for pediatric oncology patients, in 17 scaled questions. Each question scaled 0-4 (0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Almost Always). The higher the final sum of the questions, the lower the quality of life/more severe the side effects of oncology treatment. Total scores can range between 0 = highest quality of life, and 100 = experiencing most severe side effects of oncology treatment/worst quality of life experience.|Baseline, Cycle 2, Surgery, Cycle 3, Cycle 4, Cycle 5, Cycle 6, and End of Therapy|The number analyzed differed between rows and from the overall number of analyzed subjects, because not all subjects completed PROS questionnaires during study visits due to time limitations, and/or activities of the study procedures.|||score on a scale||Full Range|Mean
2630995|NCT01848457|Secondary|Nutritional Status|Nutritional status (weight, arm circumference, skin fold thickness, pre-albumin) will be throughout the course of treatment|Prior to each cycle (Day 1 of cycles 1-6) and end of therapy (at the end of cycle 6)|The nutritional information collected was not able to be reported, due to the metabolized nature of the data. The data points were not able to be included, because they were not able to be read.||||||
2630996|NCT01848457|Secondary|Bone Specific Alkaline Phosphatase (BSAP)|Serum BSAP will be longitudinally evaluated as a potential biomarker for osteosarcoma|Pretreatment/Baseline, Cycle 3||||U/L||Full Range|Mean
2630997|NCT01848457|Secondary|Tissue Microarray|Tissue microarray will be constructed from biopsy specimens, primary resection and resected metastatic tumors to evaluate the expression of proteins that are responsible for resistance to the drugs in the MAP regimen and to assess expression of proteins that are targeted by new anticancer drugs under development for childhood cancers.|Pretreatment (biopsy) at baseline and postoperative (in between cycle 2 and cycle 3)|The study was completed early and biopsy specimens were not submitted for tissue microarray analysis for any patients.||||||
2630998|NCT01848457|Secondary|Validating Urinary Biomarkers|Urinary biomarkers of acute kidney injury (AKI) and glomerular filtration rate (GFR) estimated from serum cystatin C will be compared to standard measures of renal function (serum creatinine, urinalysis, estimated creatinine clearance, fractional excretion of Mg). Single reported values are averaged and reported with full ranges.|Day 1 (Pretreatment/Baseline), Day 8, and Day 22 of Cycles 1 & 2||||mL/min per 1.73m2||Full Range|Median
2630999|NCT01848457|Secondary|Change in Tumor Volume|Response of the primary tumor to the first two treatment cycles (Cycles 1 and 2) will be assessed by quantifying the change in tumor volume on MRI, after treatment (pre-operative) relative to the pre-treatment tumor volume. By using the log ratio of the tumor volume post-treatment, to the tumor volume pre-treatment. The larger the change, the more effective the treatment.|Baseline (Week 1), Pre-operative (Month 2)||||Participants|||Count of Participants
2631000|NCT01848457|Primary|Change in Urinary Biomarkers of Acute Kidney Injury (AKI) Between Pre-Treatment (Baseline), After CISplatin (C) Treatments, and After HDTMX Treatments|"This measure describes the urinary biomarkers of AKI after each course of C throughout Cycles 1-2, compared to baseline (pre-infusion) values.~Biomarkers of AKI, include: Kidney Injury Molecule-1 (KIM-1), and Neutrophil Gelatinase‐Associated Lipocalin (NGAL)."|Pretreatment/Baseline, Day 2 of Cycles 1 & 2, Day 8 of Cycles 1 & 2|The original treatment arms/groups are paired down by the arms that include PTZ in the CISplatin infusions, and the arms that do not include PTZ in the CISplatin infusions. This is a general comparison of the changes in AKI measurements when using the PTZ inhibitor, whether HDTMX is infused for 4 or 12 hours.|||μg/g||Full Range|Median
2631001|NCT01848366|Primary|Global Response Assessment (GRA)|The GRA will be used to assess for changes in urinary condition and symptoms after 12 weekly BIOWAVE treatments. The GRA asks the participant to indicate how their condition or symptoms have changed compared to when they started the study. Eight questions addressed bladder symptoms, urine leakage related to activity, urine leakage associated with urge, urinary frequency, Interstitial Cystitis/Painful Bladder Syndrome (IC/BPS), fecal incontinence, and irritable bowel syndrome. Responses range from 1=Markedly Worse to 7=Markedly Improved.|3 months||||units on a scale||Full Range|Mean
2631002|NCT01848353|Other Pre-specified|Blood Lipids|Standard assessment of fasting triglycerides. Testing will be performed at baseline (week 0) and weeks 16, 32, and 48. Data analysis will focus on the change from baseline and whether that change differs between groups.|at baseline (week 0) and weeks 16, 32, and 48.|In Phase 1, 20 out of 77 people who started were lost to follow-up so post-test data were not available. In Phase 2, 26 out of 46 people who started were lost to follow-up. In Phase 3, 3 out of 13 people who started were lost to follow-up.|||mg/dl||Standard Deviation|Mean
2631003|NCT01848353|Other Pre-specified|Physical Activity|Daily step counts measured with accelerometers. Testing will be performed at baseline (week 0) and weeks 16, 32, and 48. Data analysis will focus on the change from baseline and whether that change differs between groups.|at baseline (week 0) and weeks 16, 32, and 48.|In Phase 1, 20 of 77 starters lost to follow-up (no post-test data). In Phase 2, 26 of 46 starters lost to follow-up. In Phase 3, 3 of 13 starters lost to follow-up. Missing data: Phase 1 (4 std, 5 incentive), Phase 2 (2 std, 3 incentive), Phase 3 (1 std, 2 incentive), NW (1 Low, 1 High).|||steps per day||Standard Deviation|Mean
2631004|NCT01848353|Secondary|Body Composition|Body fat content. Testing will be performed at baseline (week 0) and weeks 16, 32, and 48. Data analysis will focus on the change from baseline and whether that change differs between groups.|at baseline (week 0) and weeks 16, 32, and 48.|In Phase 1, 20 out of 77 people who started were lost to follow-up so post-test data were not available. In Phase 2, 26 out of 46 people who started were lost to follow-up. In Phase 3, 3 out of 13 people who started were lost to follow-up. Missing data: 1 person in NW Lo fit group.|||Total body fat percentage||Standard Deviation|Mean
2631005|NCT01848353|Secondary|Exercise Fitness|Peak oxygen uptake (VO2max) during a progressive intensity bicycle test to fatigue. Testing will be performed at baseline (week 0) and weeks 16, 32, and 48. Data analysis will focus on the change from baseline and whether that change differs between groups.|at baseline (week 0) and weeks 16, 32, and 48.|In Phase 1, 20 out of 77 people who started were lost to follow-up so post-test data were not available. In Phase 2, 26 out of 46 people who started were lost to follow-up. In Phase 3, 3 out of 13 people who started were lost to follow-up. Missing data: 2 people in Phase 1 (1 in each group), 1 person in NW low activity group.|||ml/kg fat free mass/minute||Standard Deviation|Mean
2631818|NCT01841632|Secondary|Evaluation of Data From Routine Examinations Following Last Study Visit for Evidence of Long Term Safety From MultiStem Administration|The results of routine examinations, which are necessary for all transplant patients, will be used once a year and analyzed retrospectively.|up to six years|||||||
2631006|NCT01848353|Secondary|Insulin Resistance|Fasting blood glucose and insulin concentration will be measured and used to calculate the homeostatic model of assessment for insulin resistance (iHOMA2, %S). Testing will be performed at baseline (week 0) and weeks 16, 32, and 48. Data analysis will focus on the change from baseline and whether that change differs between groups.|at baseline (week 0) and weeks 16, 32, and 48.|In Phase 1, 20 out of 77 people who started were lost to follow-up so post-test data were not available. In Phase 2, 26 out of 46 people who started were lost to follow-up. In Phase 3, 3 out of 13 people who started were lost to follow-up.|||% of sensitivity||Standard Deviation|Mean
2631007|NCT01848353|Primary|Change From Baseline in Volume of Exercise (Total Time)|Frequency and duration of moderate-to-vigorous physical activity will be measured using heart rate monitors. The monitors will be worn each exercise session. Participants are asked to complete 3 exercise sessions per week throughout the 48-week period of enrollment. The primary comparison between the experimental and active comparator groups will be the volume of exercise (total time) accumulated. Comparisons will be made for accumulated exercise volume at 16, 32, and 48 weeks and the change from baseline (week 0).|at baseline (week 0) and weeks 16, 32, and 48.|In Phase 1, 81 people were randomized, but 4 withdrew after assignment so 77 people had exercise behavior data for analyses. In Phase 2, 51 were randomized, but 5 withdrew after assignment, leaving 46 for behavior analyses. In Phase 3, 15 were randomized, 2 withdrew after assignment, leaving 13 for behavior analyses.|||hours||Standard Deviation|Mean
2631008|NCT01848288|Secondary|Aspiration Time|Aspiration Time indicated the amount of time the system was aspirating during the removal of the cataractous lens. A lower value indicates that the surgeon spent less time aspirating fluid and material from the eye during surgery.|Day 0 (operative day), each eye|This analysis population includes all participants who were randomized to a surgical system and had non-missing values at the specific time point for each arm group, respectively.|||seconds||Standard Error|Least Squares Mean
2631009|NCT01848288|Primary|Aspiration (ASP) Fluid Used|Aspiration fluid used is the amount of aspiration fluid used during the removal of the cataractous lens. A lower value indicates that less fluid was removed from the eye.|Day 0 (operative day), each eye|This analysis population includes all participants who were randomized to a surgical system and had non-missing values at the specific time point for each arm group, respectively.|||grams||Standard Error|Least Squares Mean
2631010|NCT01848288|Primary|Cumulative Dissipated Energy|Cumulative Dissipated Energy (CDE) is an estimation of the energy at the incision site experienced during the removal of cataractous lens and is measured in %-secs. The incision is defined as 5.6mm back from the cutting edge of the tip. A lower CDE indicates that less energy was present at the incision site.|Day 0 (operative day), each eye|This analysis population includes all participants who were randomized to a surgical system and had non-missing values at the specific time point for each arm group, respectively.|||percent-seconds||Standard Error|Least Squares Mean
2631011|NCT01848210|Secondary|Number of Participants With Adverse Events (AEs)|Adverse events are any unwanted medical occurrences in an individual taking part in a clinical study who is receiving a pharmaceutical product. The adverse event does not have necessarily a causal relationship with the treatment. In this definition, any adverse or unwanted signals and symptoms, or findings that appear from the start or that deteriorate during the clinical study are also included, i.e. any intercurrent diseases (recently diagnosed concomitant diseases or symptoms), accidents and clinically relevant changes in clinical laboratory values.|Baseline to Week 16|Safety Population included all randomized participants who received study drug and had a least one post-Baseline safety assessment.|||participants|||Number
2631012|NCT01848210|Secondary|Overall Assessment by the Investigator|The investigator recorded their impression of the overall clinical picture at the end of the treatment period (Week 16), taking into account the clinical picture compared with the Baseline visit. Data is reported for the percentage of participants in each of the following assessment categories: worsening, unchanged, discreet improvement or accentuated improvement.|Baseline and Week 16|Participants from the ITT population, all eligible participants who received study drug and had at least one efficacy assessment at Visit 1 (28 ± 5 days after start of treatment), with data available for analysis.|||percentage of participants|||Number
2631013|NCT01848210|Secondary|Change (Reduction) From Baseline in Local Complaint Severity|"Local Complaint Severity will be assessed using the Severity Score of Local Complaints that comprises 8 items: 1=tired legs, 2=heavy legs, 3= feeling of tension, 4=feeling of swelling, 5=aching legs, 6=tingling, 7=itching, 8=burning of soles of the feet.~Each item is classified with a Likert-type scale of 5 levels, where 0=absent, 1=low, 2=medium, 3=high, 4=very high.~A total score is calculated from the sum of the scores of all the 8 items and ranges from 0 (complaints absent) to 32 (very high severity)."|Baseline and Week 16|ITT population, all participants who received study drug and had at least one efficacy assessment at Visit 1 (28 ± 5 days after start of treatment). Last observation carried forward (LOCF).|||score on a scale||Standard Deviation|Mean
2631014|NCT01848210|Primary|Mean Change (Reduction) From Baseline in Volume of Reference Leg at Week 16|Change in the partial volume of legs will be measured using a water plethysmometer. The volume of water (at 34 ± 0.2 °C) displaced after limb immersion is collected in an empty plastic Beaker which has been previously weighed (scale tare). The equilibrium/stability will be estimated using the absolute difference between measures of volume obtained at the Week 16 visit and Baseline to determine the reduction in edema.|Baseline and Week 16|Participants from the ITT population, all eligible participants who received study drug and had at least one efficacy assessment at Visit 1 (28 ± 5 days after start of treatment), with data available for analysis.|||milliliters (mL)||Standard Deviation|Mean
2631015|NCT01848184|Other Pre-specified|Other Relevant Data: Time of Mesh Positioning|The time of the mesh positioning during surgery|Per- operative||||min||Standard Deviation|Mean
2631016|NCT01848184|Other Pre-specified|Other Relevant Data: Operative Time|Operative time during surgery for all patient receiving PCO ventral patch|Per- operative||||min||Standard Deviation|Mean
2631017|NCT01848184|Other Pre-specified|Mesh Handling Ease of Use During Surgery|Ease of use (mesh handling and comfort of use). Surgeons were asked if they were satisfied or completely satisfied, unsatisfied or completely dissatisfied|Per- operative|Overal patients treated with PCO Ventral patch|||Participants|||Count of Participants
2631865|NCT01840943|Secondary|Area Under the Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.||||||
2631022|NCT01848145|Secondary|Number of Patients With Infusion-related Reactions Assessed According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.0.|Patients who received at least 1 dose of protocol treatment either Infusion #1 (300 mg), Infusion #2 (1000 mg) or Infusion #3 (2000 mg) are included in the assessment.|up to 28 weeks||||participants|||Number
2631023|NCT01848145|Secondary|Overall Survival|Defined as the time from first treatment until death from any cause.|For 28 weeks during therapy then every 3 months for 2 years and every 6 months thereafter.||||months||95% Confidence Interval|Median
2631024|NCT01848145|Secondary|Progression Free Survival|Defined as the time from first treatment until objective tumor progression or death from any cause.|For 28 weeks during therapy then every 3 months for 2 years and every 6 months thereafter.|All patients who received at least 1 dose of protocol treatment.|||months||95% Confidence Interval|Median
2631025|NCT01848145|Secondary|Overall Response Rate (ORR)|Defined as the percent of patients having a complete or partial response (CR or PR) assessed by International Workshop on CLL Working Group (IWCLLWG) Diagnostic Criteria (Hallek et al., 2008). CR = (a) Peripheral blood lymphocytes below 4000/µl; (b) Absence of significant lymphadenopathy by physical exam or radiographic scans (c) No hepatomegaly or splenomegaly; (d) Absence of constitutional symptoms; and blood counts above specified values. PR = (a) Decreased blood lymphocytes by 50% or more from the value prior to therapy;(b) No increase in any lymph node, and no new enlarged lymph node. Progressive Disease (PD) = An increase in 50% or more in greatest determined diameter of any previous site. Stable Disease (SD) = No evidence of CR or PR and no evidence of progressive disease.|At weeks 12 and 28|All evaluable patients. 3 patients discontinued prior to assessment.|||percentage of patients|||Number
2631026|NCT01848145|Secondary|Duration of Time to Complete Individual Infusions of an Accelerated Infusion Schedule of Ofatumumab|Defined as the actual mean infusion times, in minutes, for patients to complete a schedule of 3 infusions with the goal of completing Infusion #3 within 15 minutes of the planned 2-hour treatment time.|Week 1 - Days 1 and 3, and Week 2, Day 1|Includes all treated participants. 1 participant discontinued treatment after Infusion # 1 but prior to Infusion #2. 2 participants discontinued treatment after Infusion #2 but prior to Infusion #3|||minutes||Full Range|Mean
2631027|NCT01848145|Primary|Percent of Patients Who Complete an Accelerated Infusion Regimen Within 15 Minutes of the Planned 2-hour Treatment.|Defined as percent of patients who are able to complete the Day 8 (2000 mg IV Ofatumumab) infusion within 15 minutes of the planned 2-hour treatment goal.|At Week 2, Day 1 of therapy|Patients who completed Infusion #3 within the 2 hour treatment goal.|||percentage of participants|||Number
2631028|NCT01848067|Secondary|Number of Participants With a PSA Value Equal to or Greater Than 25%|Compared between the two patient subsets using the nonparametric Mann-Whitney test. A comparison of CTC counts between baseline and at progression for those who have progressed will be carried out using either a paired t test or the nonparameteric Wilcoxon matched pairs test.|Baseline up to 3 months||||Participants|||Count of Participants
2631029|NCT01848067|Primary|Phase II: Duration of Progression Free Survival According to the PCWG2 Criteria|The Kaplan-Meier product limit method will be used to estimate the probability distribution of progression free survival (PFS). The proportion of patients achieving at least a 50% decline from baseline will be reported with a 95% confidence interval. The results will be presented graphically using a waterfall plot.|12 weeks|The toxicity / efficacy ratio did not warrant further pursuing this treatment and the trial was terminated earlier after discussion with sponsor. Trial did not progress to Phase II.||||||
2631030|NCT01848067|Primary|Phase I: Frequency of Dose Limiting Toxicities of Alisertib, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.1|Summarized with descriptive statistics.|Up to 21 days||||Participants|||Count of Participants
2631031|NCT01848054|Secondary|Retention in Treatment in the Full Analysis Population|Retention in treatment at Day 3 in the full analysis population (N=310) was defined as the number of patients in each induction arm completing the induction phase and who received study medication on Day 3. Treatment with BNX sublingual tablets was considered non-inferior to generic buprenorphine if the lower limit of the 95% confidence interval for the difference between BNX and generic buprenorphine was ≥-10% in the number of patients retained in treatment on Day 3.|Day 3|Full analysis population; patients with missing data were excluded from the analysis|||participants|||Number
2631032|NCT01848054|Secondary|Mean Change From Baseline in the VAS Score for Cravings After Day 3 (Maintenance Phase)|"Mean change from baseline in VAS scores for cravings during the maintenance phase (Days 4, 8, 15, 22, and 29); the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)"|Pre-dose on Days 4, 8, 15, 22, and 29|Full analysis population; patients with missing data were excluded from the analysis|||units on a scale||Standard Deviation|Mean
2631033|NCT01848054|Secondary|Mean Change From Baseline in SOWS Total Score After Day 3 (Maintenance Phase)|Mean change from baseline in SOWS total scores during the maintenance phase (Days 4, 8, 15, 22, and 29); SOWS scores range from 0-64, with a lower score being more favorable|Pre-dose on Days 4, 8, 15, 22, and 29|Full analysis population; patients with missing data were excluded from the analysis|||units on a scale||Standard Deviation|Mean
2631034|NCT01848054|Secondary|Mean Change From Baseline in COWS Total Score After Day 3 (Maintenance Phase)|Mean change from baseline in COWS total scores during the maintenance phase (Days 4, 8, 15, 22, and 29); COWS scores range from 0-48, with a lower score being more favorable|Predose on Days 4, 8, 15, 22, and 29|Full analysis population; patients with missing data were excluded from the analysis|||units on a scale||Standard Deviation|Mean
2631035|NCT01848054|Secondary|AUC in Visual Analog Scale (VAS) Score for Craving on Days 1 to 3 Inclusive|"Least squares mean AUC measurement in VAS score for cravings on Days 1 to 3; the VAS craving scores range from 0 (no cravings) to 100 (most intense craving I have ever had)"|Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1|Full analysis population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed|||score x hour||Standard Deviation|Least Squares Mean
2631036|NCT01848054|Secondary|AUC in Subjective Opiate Withdrawal Scale (SOWS) Total Score on Days 1 to 3 Inclusive|Least squares mean AUC day 1 pre-dose through Day 3 in SOWS; SOWS scores range from 0-64, with a lower score being more favorable|Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1|Full analysis population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed|||score x hour||Standard Deviation|Least Squares Mean
2631037|NCT01848054|Secondary|Area Under the Curve (AUC) in Clinical Opiate Withdrawal Scale (COWS) Total Score on Days 1 to 3 Inclusive|Least squares mean AUC in COWS total score on Days 1 to 3; COWS scores range from 0-48, with a lower score being more favorable|Pre-dose on Days 1-3 and 0.5, 1, 1.5, 3, and 6 hours post-dose on Day 1|Full analysis population|||score x hour||Standard Deviation|Least Squares Mean
2631038|NCT01848054|Primary|Retention in Treatment in the Per Protocol Population|Retention in treatment at Day 3 in the per protocol population (n=256) was defined as the number of patients in each induction arm completing the induction phase and who received study medication on Day 3. Treatment with BNX sublingual tablets was considered non-inferior to generic buprenorphine if the lower limit of the 95% confidence interval for the difference between BNX and generic buprenorphine was ≥-10% in the number of patients retained in treatment on Day 3.|Day 3|Per protocol population|||participants|||Number
2631039|NCT01847885|Post-Hoc|30% Reduction in Pain Interference From Baseline to End of Treatment (EOT)|"The degree to which shoulder pain interferes with daily activities was assessed using Question 9 of the Brief Pain Inventory (BPI-9) collected from the BPI Short Form administered during clinic visits. This question asks the subject to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life on a scale of 0 to 10, where 0 is does not interfere and 10 is completely interferes within the last week. The mean of these seven scores was calculated to obtain the pain interference score. The score at End of Treatment (EOT) was compared to the baseline score to determine the percentage of subjects who had a clinically significant (30% or greater) reduction in pain interference."|4 weeks (from baseline visit to EOT visit)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment)|||Participants|||Count of Participants
2631040|NCT01847885|Post-Hoc|Composite 30% Reduction in Pain Intensity or Pain Interference From Baseline to End of Treatment (EOT)|"Subjects who reported an reduction of at least 30% in either pain intensity or pain interference from baseline to End of Treatment (EOT) using the Brief Pain Inventory (BPI) Short Form.~The pain intensity score is excerpted from BPI question 3, worst pain, taken from 7-day diaries. This scale ranges from 0 representing no pain to 10 representing worst pain. The median diary score at EOT was compared to the median baseline diary score to calculate the percentage of subjects who had at least a 30% reduction in pain intensity.~Pain interference was assessed using BPI question 9. Subjects rated the degree to which their pain interfered with seven facets of daily life on a scale of 0 to 10, where 0 is does not interfere and 10 is completely interferes. The mean of these 7 scores was calculated to obtain the pain interference score. The score at EOT was compared to the baseline score to determine the percentage of subjects who had at least a 30% reduction in pain interference."|4 weeks (from baseline visit to EOT visit)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment)|||Participants|||Count of Participants
2631041|NCT01847885|Other Pre-specified|Performance of the Smartpatch System|A sponsor-developed Clinician Satisfaction Survey was administered to the Investigator(s) at each site performing lead placement and included questions pertaining to use of the Smartpatch device as well as the overall impression of the therapy.|At completion of study, approximately 2.5 years|"Count of participants represents Investigators responding to the survey rather than study participants."|||Participants|||Count of Participants
2631042|NCT01847885|Other Pre-specified|User Satisfaction With The Smartpatch System at 12-weeks Beyond Treatment|Subjects completed the sponsor-developed Subject Satisfaction Survey at the end of the 12-week post-treatment period. The results of these surveys demonstrate the usability of the Smartpatch System and subject satisfaction with treatment.|12-week post-treatment|Safety set (Subjects who were implanted with a Smartpatch Lead)|||Participants|||Count of Participants
2631043|NCT01847885|Other Pre-specified|User Satisfaction With The Smartpatch System at End of Treatment|Subjects completed the sponsor-developed Subject Satisfaction Survey at the End of Treatment (EOT) visit. The results of these surveys demonstrate the usability of the Smartpatch System and subject satisfaction with treatment.|End of Treatment (4-weeks of Treatment/Control)|Safety set (Subjects who were implanted with a Smartpatch Lead)|||Participants|||Count of Participants
2631044|NCT01847885|Secondary|Clinical Global Impression of Improvement at End of Treatment|"The Blinded Evaluator rated each subject enrolled at their site using a question adapted from the Clinical Global Impression (CGI) scale, known as the Clinical Global Impression-Improvement scale (CGI-I). For the CGI-I, a Blinded Evaluator was asked to rate the subject's total improvement compared to their condition at baseline. The CGI-I uses a 7-point scale (centered at 4) that ranges from very much worse to very much improved."|End of Treatment (4-weeks of Treatment/Control)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment). The CGI-I was not completed for one subject in the treatment group.|||Participants|||Count of Participants
2631045|NCT01847885|Secondary|Change in Pain Medication Usage at End of Treatment|"Subjects completed 7-day diaries, in which they listed all pain medications they took during the 7 days. A blinded third party medication committee reviewed medications collected for each 7-day diary period and scored medication changes, in comparison to the baseline diary medications as no change (no change in dosage or change is not clinically meaningful to impact pain outcomes), increase (clinically meaningful increase in medication that would impact pain outcomes), or decrease (clinically meaningful decrease in medication that would impact pain outcomes)."|End of Treatment (4-weeks of Treatment/Control)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment)|||Participants|||Count of Participants
2631065|NCT01847547|Secondary|Incidence Rate of Stroke Uncertain Classification|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
2631046|NCT01847885|Secondary|Patient Global Impression of Change at End of Treatment|"The Patient Global Impression of Change (PGIC) scale was administered at EOT to assess subject perception of overall improvement and patient preferences. The PGIC scale asks subjects to rate their improvement with treatment on a 7-point scale (centered at 4) that ranges from very much worse to very much improved relative to baseline."|End of Treatment (4-weeks of Treatment/Control)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment)|||Participants|||Count of Participants
2631047|NCT01847885|Secondary|Change From Baseline Average Pain Intensity at End of Treatment|"A diary was used in the study to capture daily average shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 5 (BPI-5) and is stated as please rate your pain by circling the one number that best describes your pain on the average. BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The mean scores were calculated for each diary period. The mean diary score at End of Treatment (EOT) was compared to the mean baseline diary score to calculate the change in pain intensity."|Baseline, End of Treatment (4-weeks of Treatment/Control)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment)|||scores on a scale||Standard Deviation|Mean
2631048|NCT01847885|Secondary|Change From Baseline Quality of Life at End of Treatment|The Medical Outcomes Study Short Form (SF-36v2) was administered at clinic visits to assess the impact of peripheral nerve stimulation on the subject's health-related quality of life. The SF-36v2 is a generic health survey designed to assess basic physical functioning and emotional well-being regardless of the disease or treatment. The 36 questions were grouped into two components: physical and mental. The survey was scored using norm-based scoring algorithm where a score of 0 indicates maximum disability and a score of 100 indicates no disability. Change in each component score was derived from End of Treatment score minus baseline score.|Baseline, End of Treatment (4-weeks of Treatment/Control)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment)|||scores on a scale||Standard Deviation|Mean
2631049|NCT01847885|Secondary|Durability of Change From Baseline Shoulder Pain Intensity at 12-weeks Beyond Treatment|"A diary was used in the study to capture daily worst shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 3 (BPI-3) and is stated as please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours. BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The median scores were calculated for each diary period. The median diary score at 12 weeks post-treatment was compared to the median baseline diary score to calculate the change in pain intensity. The group mean of the median scores for 12 weeks post-treatment was compared to the group mean of the median scores for the control group at baseline."|Baseline, 12-wks post-treatment|Full analysis set|||scores on a scale||Standard Deviation|Mean
2631050|NCT01847885|Secondary|Change From Baseline Shoulder Pain Interference at End of Treatment|"The degree to which shoulder pain interferes with daily activities was assessed using Question 9 of the Brief Pain Inventory (BPI-9) collected from the BPI Short Form administered during clinic visits. This question asks the subject to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life on a scale of 0 to 10, where 0 is does not interfere and 10 is completely interferes within the last week. The mean of these seven scores will be calculated to obtain the pain interference score."|Baseline, End of Treatment (4-weeks of Treatment/Control)|Per protocol set (Subjects in the full analysis set who also were implanted with a Smartpatch Lead, had an adequate number of worst pain intensity (BPI3) scores in the End of Treatment subject diary period, and continued to meet all eligibility criteria throughout treatment).|||scores on a scale||Standard Deviation|Mean
2631051|NCT01847885|Primary|Number of Participants With Device Related Adverse Event Rates in Treatment and Control Groups|At each study visit following the baseline assessment, subjects were questioned if any changes in their medical status or condition had occurred. If the change was an adverse event, an adverse event form was completed by the site.|16 weeks total - 4 weeks from baseline visit to EOT visit, followed by 12 weeks post-treatment|Safety set|||device related adverse events|||Number
2631052|NCT01847885|Primary|Change From Baseline Shoulder Pain Intensity at End of Treatment (EOT)|"A diary was used in the study to capture daily worst shoulder pain intensity over a 7-day period. The diary included a pain intensity question asked each day to the subject. The pain intensity question is excerpted from the Brief Pain Inventory - Short Form Question 3 (BPI-3) and is stated as please rate your pain by circling the one number that best describes your pain at its worst in the last 24 hours. BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. The median scores were calculated for each diary period. The median diary score at End of Treatment (EOT) was compared to the median baseline diary score to calculate the change in pain intensity. The group mean of the median scores for treatment was compared to the group mean of the medians scores for the control group at baseline and at EOT."|Baseline, End of Treatment (4-weeks of Treatment/Control)|Full analysis set|||scores on a scale||Standard Deviation|Mean
2631053|NCT01847638|Other Pre-specified|Retinal Thickness|Change in Retinal Thickness from baseline to final postoperative visit as measured by an SD-OCT|change from baseline to final postoperative visit at 42 days +/- 7 days|Patients undergoing uncomplicated phacoemulsification with lens implantation at a single center by a single surgeon.|||microns||Standard Deviation|Mean
2631054|NCT01847638|Secondary|Visual Acuity|ETDRS log MAR Visual Acuity from baseline to final postoperative visit. The change was calculated as the difference of the value at the later time point minus the value at the earlier time point. The scale runs from -0.30 (corresponding to 20/10) or better visual acuity to 1(20/200) or worse visual acuity with the smaller or more negative numbers indicating better visual acuity outcomes and larger numbers indicating worsened visual acuity outcomes.|baseline score to final postoperative visit at 42 days +/-7 days|patients undergoing uncomplicated cataract surgery|||logMar||Standard Deviation|Mean
2631055|NCT01847638|Primary|Treatment of Inflammation Associated With Cataract Surgery|Units on a scale. Biomicroscopy with slit lamp beam of 0.3 mm in width and 1.0 mm in height will be used to determine anterior cell and flare scores at each study visit by counting each individual white blood cell present and grading the flare (measure of protein and marker of inflammation in aqueous fluid). The sum of the severity of cell count and the flare grade will be called the Summed Ocular Inflammation Score (SOIS) and measured at each time point. The scale is 0-4 range for both values cells counted and flare where 0=no cell and 0=complete abscence of flare; 0.5 = 1-5 cells (trace) and 0= no flare; 1=6-15 cells and 1=very slight (barely detectable ) flare, 2=16-25 cells and 2=moderate flare (iris and lens clear), 3=26-30 cells and 3 =marked (iris and lens hazy) and 4=>|change from baseline to final at post op 42 days +/-7 days|patients undergoing uncomplicated cataract surgery|||units on a scale||Standard Deviation|Mean
2631056|NCT01847560|Secondary|Treatment Persistence Over Time|Overall treatment persistence in UnitedHealth and MarketScan cohorts are presented as the percentage of patients who were persistent to treatment after 3, 6 and 12 months of follow-up for all time periods combined and matched cohort. Based on two US-based longitudinal healthcare claims databases (MarketScan and unitedHealth Research Database) the three separate study cohorts warfarin vs dabigatran, warfarin vs rivaroxaban and warfarin vs apixaban cohort were formed for each database.|From January 2009 to September 2015 (The study period)|Patients were matched within calendar quarters (3 months period) the various NOACs were individually matched to warfarin on an exposure propensity score (PS) in a 1:1 fixed ratio using a nearest neighbor technique and a caliper of 0.05.|||Percentage of participants (%)|||Number
2631057|NCT01847560|Primary|Percentage of Patients Initiating Specific Anticoagulant Dose - Rivaroxaban|Percentage of patients initiating specific anticoagulant dose of rivaroxaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.|From January 2009 to September 2015 (The study period)|Patients initiating treatment in source cohort.|||Percentage of initiators (%)|||Number
2631058|NCT01847560|Primary|Percentage of Patients Initiating Specific Anticoagulant Dose - Apixaban|Percentage of patients initiating specific anticoagulant dose of apixaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.|From January 2009 to September 2015 (The study period)|Patients initiating treatment in source cohort.|||Percentage of initiators (%)|||Number
2631059|NCT01847560|Primary|Percentage of Patients Initiating Specific Anticoagulant Dose - Dabigatran|Percentage of patients initiating specific anticoagulant dose of dabigatran across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.|From January 2009 to September 2015 (The study period)|Patients initiating treatment in source cohort.|||Percentage of initiators (%)|||Number
2631060|NCT01847560|Primary|Percentage of Patients Initiating Specific Anticoagulant|"Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage. This is related to UnitedHealth database and no treatment initiation rate was estimated in MarketScan as the study cohort was defined from a population of oral anticoagulants users. The overall number of participants analyzed 609201 reported for each of the treatment arm below corresponds to overall patients numbers in UnitedHealth for the entire study period rather than for each of the treatment arm. Likewise the number of participants for each of the treatment arm for different time period corresponds to the total number of participants for the specific study period rather than for each of the treatment arm. Incident users at given time period could also be counted in later time period if the patient discontinued the drug and had re-entry during the study period."|From January 2009 to September 2015 (The study period)|Source cohort in a calendar time window includes all patients with at least one day eligibility. A random date within the time window selected and set as the index date. Patients dispensed of an anticoagulant before assigned index date will be removed, unless they are identified as new initiators for that particular time period.|||Percentage of initiators (%)|||Number
2631061|NCT01847560|Primary|Description of the Characteristics of Anticoagulant Initiators|The analyses described the characteristics of patients treated with various oral anticoagulants. CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure/ Left ventricular (LV) dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ transient ischemic attack (TIA) /thromboembolism, Vascular disease, Age 65-74, female gender. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalized ratio (INR), Elderly (>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. New initiators of warfarin before Dabigatran became available were only characterized in terms of age and sex (results provided above).|From January 2009 to September 2015 (The study period)|All patients with nonvalvular atrial fibrillation at risk for stroke initiating oral anticoagulants and a description of existing utilization patterns for warfarin and for the new oral anticoagulant (NOAC) medications as they become available over time.|||Scores on a scale||Standard Deviation|Mean
2631062|NCT01847547|Secondary|Incidence Rate of Major Gastrointestinal Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
2631063|NCT01847547|Secondary|Incidence Rate of Major Extracranial Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
2631064|NCT01847547|Secondary|Incidence Rate of Major Intracranial Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
2631066|NCT01847547|Secondary|Incidence Rate of Hemorrhagic Stroke|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
2631067|NCT01847547|Secondary|Incidence Rate of Ischemic Stroke|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
2631068|NCT01847547|Secondary|Incidence Rate of Systemic Embolism|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
2631069|NCT01847547|Secondary|Incidence Rate of Stroke or Systemic Embolism|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
2631070|NCT01847547|Secondary|Incidence Rate of Major Upper Gastrointestinal Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
2631071|NCT01847547|Secondary|Incidence Rate of Transient Ischemic Attack|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
2631072|NCT01847547|Secondary|Incidence Rate of Major Other Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
2631073|NCT01847547|Secondary|Incidence Rate of Major Urogenital Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
2631074|NCT01847547|Secondary|Incidence Rate of Major Lower Gastrointestinal Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
2631075|NCT01847547|Secondary|Incidence Rate of Pulmonary Embolism|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
2631076|NCT01847547|Secondary|Incidence Rate of Deep Vein Thrombosis|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
2631077|NCT01847547|Secondary|Incidence Rate of Venous Thromboembolism|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
2631078|NCT01847547|Secondary|Incidence Rate of Myocardial Infarction|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
2631079|NCT01847547|Primary|Incidence Rate of Major Bleeding|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 and procedure codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
2631080|NCT01847547|Primary|Incidence Rate of Stroke|Events during follow-up (October 2010- 30 June 2012) were identified using ICD 9 codes.|From treatment initiation until end of follow-up; up to 20 months|Hazard ratios and confidence intervals were estimated for patients starting dabigatran or warfarin after matching on the propensity score.|||events per 1000 person years|||Number
2631081|NCT01847469|Primary|Clinician-Administered PTSD Scale (CAPS) Total Score|"The Clinician-Administered PTSD Scale (CAPS) Total Score will be used to measure PTSD symptoms at the end of the 12 week intervention. The CAPS Total Score is a summing of the 17 items that are each scored 0-4- where 0 indicates none. The range of Total Scores can be 0 to 136, where 136 would be the highest amount of scored PTSD symptoms."|12 weeks|The intention to treat population was used in the analysis.|||units on a scale||Standard Error|Mean
2631082|NCT01847469|Primary|Number of Heavy Drinking Days|"Timeline Follow Back (TLFB) will be used to document the number of heavy drinking days during 12 weeks of treatment. Heavy drinking is defined as greater than or equal to 5 drinks for men and greater than or equal to 4 drinks for women."|12 weeks|The intention to treat population was used in the analysis.|||days||Standard Error|Mean
2631083|NCT01847469|Primary|Number of Drinking Days|Using a 90 day Timeline Follow Back (TLFB), the total number of drinking days at baseline and at 12 weeks of treatment were used.|12 weeks|The intention to treat population was used in the analysis.|||days||Standard Error|Mean
2631084|NCT01847443|Primary|Cmax of Nicotine 4 mg Test and Reference Product|Cmax for 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post-dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.|||ng/mL||Standard Deviation|Mean
2631085|NCT01847443|Primary|Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product|Cmax for 2 mg test was compared with 2 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.|||ng/mL||Standard Deviation|Mean
2631086|NCT01847443|Primary|AUC(0-t) of Nicotine 4 mg Test and Reference Product|AUC(0-t) of Nicotine 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1of 4 treatment sequences; took atleast one dose of study medication (both test and ref) in 2 mg dose and/or in 4 mg doses; did not have any AE assimilated to vomiting in first 4h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.|||hr*ng/mL||Standard Deviation|Mean
2631087|NCT01847443|Secondary|Area Under Concentration-time Curve From Time 0 Extrapolated to ∞ [AUC(0-∞)] of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products|AUC(0-∞) for 2mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.|||hr*ng/mL||Standard Deviation|Mean
2631088|NCT01847443|Secondary|Apparent Terminal Elimination Rate Constant (Kel) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products|Kel for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.|||1/hr||Full Range|Median
2631089|NCT01847443|Secondary|Apparent Terminal Elimination Half-life (T1/2) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products|T1/2 of 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.|||hr||Full Range|Median
2631090|NCT01847443|Secondary|Time to Maximum Observed Concentration (Tmax) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products|Tmax for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.|||hr||Full Range|Median
2631091|NCT01847443|Primary|Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product|AUC(0-t) for 2 mg test was compared with 2 mg reference gum|Blood samples to be collected from baseline to 12 hours post dose|Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration >5% of Cmax.|||hr*ng/mL||Standard Deviation|Mean
2631092|NCT01847430|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|Serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|During the entire study period (Day 0 to Month 1)|Analysis was performed on the Total Vaccinated cohort which included all subjects who received the challenge dose of HBV vaccine.|||Participants|||Count of Participants
2631093|NCT01847430|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) follow-up period after the challenge dose|Analysis was performed on the Total Vaccinated cohort which included all subjects who received the challenge dose of HBV vaccine.|||Participants|||Count of Participants
2631094|NCT01847430|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C|During the 4-day (Days 0-3) follow-up period after the challenge dose|Analysis was performed on the Total Vaccinated cohort which included all subjects who received the challenge dose of HBV vaccine.|||Participants|||Count of Participants
2631095|NCT01847430|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. >50 mm.|During the 4-day (Days 0-3) follow-up period after the challenge dose|Analysis was performed on the Total Vaccinated cohort which included all subjects who received the challenge dose of HBV vaccine.|||Participants|||Count of Participants
2631096|NCT01847430|Secondary|Number of Subjects With an Anamnestic Response to the Challenge Dose in Relation to Their Pre Vaccination Status.|"Anamnestic response to the challenge dose was defined as:~At least (i.e. greater than or equal to ) 4-fold rise in post-vaccination anti-HBs antibody concentrations in subjects seropositive at the pre-vaccination time point Post-vaccination anti-HB antibody concentrations ≥10 mIU/mL in subjects seronegative at the pre-vaccination time point"|Prior to vaccination with the challenge dose|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of HBV and for whom data concerning immunogenicity outcome measures were available at the time point after the HBV challenge dose.|||Participants|||Count of Participants
2631097|NCT01847430|Secondary|Antibody Titers Against Hepatitis B Virus|Antibody titers were summarized by geometric mean concentrations (GMCs) with their 95% CIs.|Before (Day 0) and one month (Month 1) after the challenge dose|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of HBV and for whom data concerning immunogenicity outcome measures were available at the time point after the HBV challenge dose.|||mIU/mL||95% Confidence Interval|Geometric Mean
2631098|NCT01847430|Secondary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut Off Value.|The cut-off values defined were ≥ 6.2 mIU/mL, ≥ 10 mIU/mL and ≥ 100 mIU/mL.|Before (Day 0) and one month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of HBV and for whom data concerning immunogenicity outcome measures were available at the time point after the HBV challenge dose.|||Participants|||Count of Participants
2631099|NCT01847430|Primary|Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut Off Value.|The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).|One month after the challenge dose (Month 1)|The analysis was performed on the according-to-protocol (ATP) cohort of immunogenicity on all evaluable subjects who had received a challenge dose of HBV and for whom data concerning immunogenicity outcome measures were available at the time point after the HBV challenge dose.|||Participants|||Count of Participants
2631100|NCT01847313|Other Pre-specified|Safety in All Participants as Measured by Adverse Event Rate|Adverse event data collection|Up to 34 weeks|||||||
2631101|NCT01847313|Secondary|sCD163:Creatinine Ratio in Urine|Spot urine sample for MCP-1 and creatinine|Up to 26 weeks||||pg/mmol||Standard Deviation|Mean
2631102|NCT01847313|Secondary|sCD163 in Serum|Serum sample for sCD163|Up to 26 weeks||||ng/ml||Standard Deviation|Mean
2631103|NCT01847313|Secondary|Urinary Albumin Excretion Rate|Albuminuria as Measured by 24 Hour Albumin Excretion Rate|Up to 26 weeks||||µg/min||Standard Deviation|Mean
2631104|NCT01847313|Secondary|Urine Albumin:Creatinine Ratio|Spot urine sample for albumin and creatinine|Up to 26 weeks|||||||
2631105|NCT01847313|Primary|MCP-1:Creatinine Ratio in Urine|Spot urine sample for MCP-1 and creatinine|Up to 26 weeks|Liraglutide group contained an analytical outlier which was excluded from further analysis.|||ng/mmol||Standard Deviation|Mean
2631106|NCT01847274|Secondary|Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA|"EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: no problems (Level 1), slight problems (Level 2), moderate problems (Level 3), severe problems (Level 4), and extreme problems (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement."|At Post Progression|Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.|||units on a scale||Standard Deviation|Mean
2631107|NCT01847274|Secondary|Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA|"EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: no problems (Level 1), slight problems (Level 2), moderate problems (Level 3), severe problems (Level 4), and extreme problems (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement."|At Cycle 6|Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.|||units on a scale||Standard Deviation|Mean
2631114|NCT01847274|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With no Germline BRCA|"The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 (severely symptomatic) to 32 (asymptomatic). A positive change from baseline indicates improvement."|At Post Progression|Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.|||units on a scale||Standard Deviation|Mean
2631108|NCT01847274|Secondary|Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA|"EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: no problems (Level 1), slight problems (Level 2), moderate problems (Level 3), severe problems (Level 4), and extreme problems (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement."|At Cycle 4|Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.|||units on a scale||Standard Deviation|Mean
2631109|NCT01847274|Secondary|Change From Baseline in EQ-5D-5L in Cohort With no Germline BRCA|"EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: no problems (Level 1), slight problems (Level 2), moderate problems (Level 3), severe problems (Level 4), and extreme problems (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement."|At Cycle 2|Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.|||units on a scale||Standard Deviation|Mean
2631110|NCT01847274|Secondary|Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA|"EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: no problems (Level 1), slight problems (Level 2), moderate problems (Level 3), severe problems (Level 4), and extreme problems (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement."|At Post Progression|Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.|||units on a scale||Standard Deviation|Mean
2631111|NCT01847274|Secondary|Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA|"EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: no problems (Level 1), slight problems (Level 2), moderate problems (Level 3), severe problems (Level 4), and extreme problems (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement."|At Cycle 6|Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.|||units on a scale||Standard Deviation|Mean
2631112|NCT01847274|Secondary|Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA|"EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: no problems (Level 1), slight problems (Level 2), moderate problems (Level 3), severe problems (Level 4), and extreme problems (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement."|At Cycle 4|Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.|||units on a scale||Standard Deviation|Mean
2631113|NCT01847274|Secondary|Change From Baseline in EQ-5D-5L in Cohort With Germline BRCA|"EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: no problems (Level 1), slight problems (Level 2), moderate problems (Level 3), severe problems (Level 4), and extreme problems (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement."|At Cycle 2|Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.|||units on a scale||Standard Deviation|Mean
2631866|NCT01840943|Secondary|Time to Reach the Maximum Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.||||||
2631115|NCT01847274|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With no Germline BRCA|"The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 (severely symptomatic) to 32 (asymptomatic). A positive change from baseline indicates improvement."|At Cycle 6|Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.|||units on a scale||Standard Deviation|Mean
2631116|NCT01847274|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With no Germline BRCA|"The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 (severely symptomatic) to 32 (asymptomatic). A positive change from baseline indicates improvement."|At Cycle 4|Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.|||units on a scale||Standard Deviation|Mean
2631117|NCT01847274|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With no Germline BRCA|"The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 (severely symptomatic) to 32 (asymptomatic). A positive change from baseline indicates improvement."|At Cycle 2|Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.|||units on a scale||Standard Deviation|Mean
2631118|NCT01847274|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With Germline BRCA|"The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 (severely symptomatic) to 32 (asymptomatic). A positive change from baseline indicates improvement."|At Post Progression|Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.|||units on a scale||Standard Deviation|Mean
2631119|NCT01847274|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With Germline BRCA|"The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 (severely symptomatic) to 32 (asymptomatic). A positive change from baseline indicates improvement."|At Cycle 6|Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.|||units on a scale||Standard Deviation|Mean
2631120|NCT01847274|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With Germline BRCA|"The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 (severely symptomatic) to 32 (asymptomatic). A positive change from baseline indicates improvement."|At Cycle 4|Intent-to-treat population (all randomized patients with patients analyzed according to the study drug assigned) with available data.|||units on a scale||Standard Deviation|Mean
2631121|NCT01847274|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI) in Cohort With Germline BRCA|"The FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale. The total symptom index is calculated as the total of the 8 scores, ranging from 0 (severely symptomatic) to 32 (asymptomatic). A positive change from baseline indicates improvement."|At Cycle 2|Intent-to-treat population (all randomized patients with patients analyzed to the study drug assigned) with available data.|||units on a scale||Standard Deviation|Mean
2631122|NCT01847274|Secondary|Time to Second Subsequent Therapy (TSST) in Cohort With No Germline BRCA Mutation (Non-gBRCA)|"Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment, including outcome of such therapy, any new malignancies, and survival status. TSST is defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death.~Results not yet reported."|From the date of randomization to the start date of the second subsequent anti-cancer therapy.|||2020||||
2631123|NCT01847274|Secondary|Time to Second Subsequent Therapy (TSST) in Cohort With Germline BRCA Mutation (gBRCA)|"Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment, including outcome of such therapy, any new malignancies, and survival status. TSST is defined as the date of randomization to the earlier of the start date of second follow-up anti-cancer treatment or death.~Results not yet reported."|From the date of randomization to the start date of the second subsequent anti-cancer therapy.|||2020||||
2631124|NCT01847274|Secondary|Overall Survival (OS) in Cohort With No Germline BRCA Mutation (Non-gBRCA)|"Patients were to be followed off treatment every 3 months for survival status. Overall survival is defined as the date of randomization to the date of death by any cause.~Results not yet reported."|From treatment randomization to date of death by any cause|||2020||||
2631125|NCT01847274|Secondary|Overall Survival (OS) in Cohort With Germline BRCA Mutation (gBRCA)|"Patients were to be followed off treatment every 3 months for survival status. Overall survival is defined as the date of randomization to the date of death by any cause.~Results not yet reported."|From treatment randomization to date of death by any cause|||2020||||
2631136|NCT01847209|Primary|Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0|The patient will be monitored while in the hospital by their thoracic surgical team as well as by two research nurses named Lauren Donahue, RN and Karen Magsipoc, NP. The research nurses will document any perioperative complications and mortality that arise during the patient's stay in the hospital.|30 days||||Participants|||Count of Participants
2631137|NCT01847196|Secondary|Device Performance||From the time of Angel® Catheter insertion through Angel® Catheter removal, for up to 30 days||||device malfunctions|||Number
2631126|NCT01847274|Secondary|Progression-Free Survival 2 (PFS2) in Cohort With No Germline BRCA Mutation (Non-gBRCA)|"Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment, including outcome of such therapy, any new malignancies, and survival status. PFS2 was defined as the time from treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause.~This study is ongoing, PFS2 is immature at this stage of primary analysis."|From treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause.|Intent-to-treat (ITT) population defined as all randomized patients with patients analyzed according to the study drug assigned via randomization.|||months||95% Confidence Interval|Median
2631127|NCT01847274|Secondary|Progression-Free Survival 2 (PFS2) in Cohort With Germline BRCA Mutation (gBRCA)|"Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment, including outcome of such therapy, any new malignancies, and survival status. PFS2 was defined as the time from treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause.~This study is ongoing, PFS2 is immature at this stage of primary analysis."|From treatment randomization to the earlier of the date of disease progression on the next anti-cancer therapy following study treatment or death due to any cause.|Intent-to-treat (ITT) population defined as all randomized patients with patients analyzed according to the study drug assigned via randomization.|||months||95% Confidence Interval|Median
2631128|NCT01847274|Secondary|Chemotherapy-Free Interval (CFI) in Cohort With No Germline BRCA Mutation (Non-gBRCA)|CFI was defined as the time from the last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment.|From date of last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment.|Intent-to-treat (ITT) population defined as all randomized patients with patients analyzed according to the study drug assigned via randomization.|||months||95% Confidence Interval|Median
2631129|NCT01847274|Secondary|Chemotherapy-Free Interval (CFI) in Cohort With Germline BRCA Mutation (gBRCA)|CFI was defined as the time from the last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment.|From date of last platinum therapy prior to randomization to the initiation of the next anti-cancer therapy after maintenance treatment.|Intent-to-treat (ITT) population defined as all randomized patients with patients analyzed according to the study drug assigned via randomization.|||months||95% Confidence Interval|Median
2631130|NCT01847274|Secondary|Time to First Subsequent Therapy (TFST) in Cohort With No Germline BRCA Mutation (Non-gBRCA)|Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment. The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death.|From date of randomization to the earliest date of first subsequent therapy or death.|Intent-to-treat (ITT) population defined as all randomized patients with patients analyzed according to the study drug assigned via randomization.|||months||95% Confidence Interval|Median
2631131|NCT01847274|Secondary|Time to First Subsequent Therapy (TFST) in Cohort With Germline BRCA Mutation (gBRCA)|Patients were to be followed off treatment every 3 months for subsequent anti-cancer treatment. The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death.|From date of randomization to the earliest date of first subsequent therapy or death.|Intent-to-treat (ITT) population defined as all randomized patients with patients analyzed according to the study drug assigned via randomization.|||months||95% Confidence Interval|Median
2631132|NCT01847274|Primary|Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation (Non-gBRCA)|PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion.|From date of randomization to the earliest date of disease progression or death from any cause.|Intent-to-treat (ITT) population defined as all randomized patients with patients analyzed according to the study drug assigned via randomization.|||months||95% Confidence Interval|Median
2631133|NCT01847274|Primary|Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+)|PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion.|From date of randomization to the earliest date of disease progression or death from any cause|Intent-to-treat (ITT) population defined as all randomized patients with patients analyzed according to the study drug assigned via randomization.|||months||95% Confidence Interval|Median
2631134|NCT01847274|Primary|Progression-Free Survival (PFS) in Cohort With Germline BRCA Mutation (gBRCA)|PFS was defined as the time between randomization and disease progression or death from any cause. Computed tomography or magnetic resonance imaging to assess disease progression was performed at baseline, every 8 weeks through cycle 14, and then every 12 weeks until treatment discontinuation. The objective assessment of disease progression was determined by means of central radiologic and clinical review, according to Response Evaluation Criteria in Solid Tumors (RECIST),version 1.1, which was performed in a blinded fashion.|From date of randomization to the earliest date of disease progression or death from any cause.|Intent-to-treat (ITT) population defined as all randomized patients with patients analyzed according to the study drug assigned via randomization.|||months||95% Confidence Interval|Median
2631135|NCT01847209|Secondary|Patients Underwent a Successful Resection|Number of patients who underwent a successful resection which is measured by an accurate and appropriate resection in a given timeline|30 days||||Participants|||Count of Participants
2633367|NCT01826422|Primary|Body Composition (Body Fat)|We observed changes in body composition such as total body fat by Dual X-ray Absorptiometry (DXA).|At baseline and at months 3 and 6 of supplementation.||||g/Kg of body weight||Full Range|Median
2631138|NCT01847196|Primary|Number of Adverse Events Occuring for All Evaluable Subjects|All Adverse Events (AEs) occurring throughout the study will be identified and characterized by seriousness, relationship to the investigational device and/or procedure, and whether un/anticipated.|From the time of subject enrollment through study exit (7 days post-removal or hospital discharge, whichever occurs first), for up to 37 days||||participants|||Number
2631139|NCT01847131|Secondary|The Numbers of Subjects Who Developed Rhinitis Medicamentosa After Using Oxymetazoline|Rhinitis medicamentosa is the rebound nasal congestion after prolonged use (>7 days) of topical nasal decongestant (eg. oxymetazoline). However, a previous study by Baroody FM et al (J Allergy Clin Immunol 2011;127:927-34) showed that using oxymetazoline together with intranasal steroid for 1 month did not increase rhinitis medicamentosa compared to placebo. So we give rhinitis patients in the treatment group with oxymetazoline and intranasal steroid for 1 month, then stop using oxymetazoline and come back for the last visit 2 weeks later to see which patients develop rebound nasal congestion (rhinitis medicamentosa).|6 weeks||||participants|||Number
2631140|NCT01847131|Primary|Effectiveness of Oxymetazoline in the Treatment of Rhinitis With Persistent Nasal Obstruction|Primary outcome measure is the nasal congestion score measuring by visual analog scale (VAS) ranging from 1-10 (0 = no symptom and 10 = the most severe symptom) compared between treatment group and controlled group.|6 weeks||||units on a scale||95% Confidence Interval|Geometric Mean
2631141|NCT01847027|Secondary|Markers of Oxidative Stress|Blood levels of C reactive protein|Baseline, 4 weeks|Subjects who completed all three visits|||ng/L||Standard Deviation|Mean
2631142|NCT01847027|Primary|Percent of CD34+ Cells|Percent of CD34+ cells detected in blood samples|Baseline, 2 weeks, 4 weeks|Subjects who completed all three visit and from whom blood draws were successful|||percent of total||Standard Deviation|Mean
2631143|NCT01847027|Primary|Percentage of CD133+ Cells|The percentage of CD133+ cells detected in blood samples|Baseline, 2 weeks, 4 weeks|subjects who completed all three visits and from whom blood draws were obtained|||percent of total||Standard Deviation|Mean
2631144|NCT01847014|Primary|Incident Rate of Adverse Events (AEs).|Safety events are reported and documented as defined in study protocol from baseline to end of treatment period including safety follow-up visit.|From Visit 1 to Post-treatment safety follow-up visit (30 days after discontinuation of the study drug).|Four participants represent the Extension Analysis Set, who transitioned from completion of SYMPHONY AC-055-401 to this open-label extension clinical trial.|||Participants|||Count of Participants
2631145|NCT01847001|Secondary|Changes in Stress Level (Score)|To explore whether acute stress levels, as measured by responses to the Questionnaire on Stress in Cancer Patients - revised version (QSC-R23), associate propranolol biomarker changes.|Approximately 6 months|||||||
2631146|NCT01847001|Secondary|Change in Tumor Density|To evaluate the changes in blood or tumor based angiogenic markers, such as tumor microvessel density, seen with propranolol plus chemotherapy.|Approximately 6 months|||||||
2631147|NCT01847001|Secondary|Change in Tumor Proliferation (Ki-67)|To evaluate reduction in tumor ki-67.|Approximately 6 months|||||||
2631148|NCT01847001|Secondary|Change in DOT-derived Parameter (Deoxyhemoglobin)|Modulation of DOT markers, such as deoxyhemoglobin, at 5 time-points will be evaluated: a) prior to propranolol and taxane therapy; b) before starting taxane week #3; c) before starting adriamycin/Cytoxan (AC) cycle #1; d) before starting AC cycle #2; and e) before surgery.|Approximately 6 months|||||||
2631149|NCT01847001|Secondary|Number of Patients With Adverse Events|To assess the safety and tolerability of neoadjuvant propranolol in combination with chemotherapy as defined by Common Toxicity Criteria for Adverse Effects v.4.0|Approximately 6 months|||||||
2631150|NCT01847001|Primary|Percentage of Patients Compliant With Taking > 80% Take the Drug While on Chemotherapy.|Feasibility will be assessed: The combination will be deemed feasible if at least 75% of patients (15 patients) are compliant with taking > 80% take the drug on a daily basis as prescribed (nonadherence/medication possession ratio < 20%). This rate is higher than the 52% compliance rate, defined by dose reduction or interruption, in other series with oral therapies in the neoadjuvant setting.|Approximately 6 months||||Percentage of propanolol adherence||Full Range|Mean
2631151|NCT01846871|Secondary|Relative Oxygen Saturation|The change in relative O2 saturation from baseline to the given time points. Oxygen saturation is a relative measure of the concentration of oxygen that is dissolved or carried in a given medium as a proportion of the maximal concentration that can be dissolved in that medium.|Baseline, Cycle 1 day 2, pre-cycle 2, pre-cycle 3 (1 cycle= 4 weeks)|One participants was not available for assessment for the cycle 1 day 2 measurement|||proportion of possible O2 concentration||Inter-Quartile Range|Median
2631152|NCT01846871|Secondary|Median Ktrans|Change in the the median Ktrans value from baseline at the given time points. The volume transfer constant (Ktrans) reflects the efflux rate of gadolinium contrast from blood plasma into the tissue extravascular extracellular space (EES)|Baseline, Cycle 1 day 2, pre-cycle 2, pre-cycle 3 (1 cycle= 4 weeks)||||mL/min/100 mL||Inter-Quartile Range|Median
2631153|NCT01846871|Secondary|Median Apparent Diffusion Coefficient (ADC)|Change in the the median ADC value from baseline at the given timepoints. Apparent diffusion coefficient (ADC) is a measure of the magnitude of diffusion (of water molecules) within tissue.|Baseline, Cycle 1 day 2, pre-cycle 2, pre-cycle 3 (1 cycle= 4 weeks)||||mm2/s||Inter-Quartile Range|Median
2631154|NCT01846871|Secondary|Change in Tumor Volume|Change in volume of the tumor in cubic centimeters at the given time points as compared to baseline|Baseline, Cycle 1 day 2, pre-cycle 2, pre-cycle 3 (1 cycle= 4 weeks)|Measurements were not available for all participants at pre-cycle 2 and pre-cycle 3|||Cubic Centimeters||Inter-Quartile Range|Median
2631155|NCT01846871|Secondary|Steroid Dosage|The number of participants on steroids at baseline and the number of participants that increased or decreased their use of steroids during the course of treatment. Participants that required an increase and decrease in steroid use over the course of treatment were counted in both categories.|2 years||||participants|||Number
2631170|NCT01846741|Secondary|Assess Changes From Baseline in Seizure Frequency|Seizure frequency was calculated at 3, 6,12 and 18 month follow-up visits based on seizure diary information and compared to baseline estimates. Response rate was computed and summarized for partial seizures (SPS, CPS and CPS with 2nd GTCs) and overall seizure types as the proportion of patients that achieved ≥50% seizure reduction per month from baseline by visit.|Up to 18 Month Visit-End of Study|ITT Population|||Percentage of Participants||95% Confidence Interval|Number
2631156|NCT01846871|Secondary|Best RANO Criteria Response|"Best response as assessed by Response Assessment in Neuro-Oncology (RANO) criteria.~Complete response~disappearance of all enhancing disease~sustained for at least 4 weeks~stable/improved non-enhancing FLAIR/T2W lesions~no new lesions~no corticosteroids~clinically stable/improved~Partial response >50% or more decrease of all measurable enhancing lesions~sustained for at least 4 weeks~no progression of non-measurable disease~stable/improved non-enhancing FLAIR/T2W lesions~no new lesions~stable/reduced corticosteroids~clinically stable/improved~Stable disease~does not qualify for complete response, partial response or progression~stable non-enhancing FLAIR/T2W lesions~stable or reduced corticosteroids~clinically stable~Progression >25% or more increase in enhancing lesions despite stable/increasing steroid dose~increase in non-enhancing FLAIR/T2W lesions, not attributable to other non-tumor causes~any new lesion~Clinical deterioration"|2 years||||Participants|||Count of Participants
2631157|NCT01846871|Secondary|Median Progression-Free Survival|"Progression free survival is measured as the amount of time from the start of treatment until the time of death or disease progression. Progressive disease was assessed using MacDonald Criteria~Progressive disease: Progressive neurologic abnormalities not explained by causes unrelated to tumor 40 progression (example: anti-epileptic drug or corticosteroid toxicity, electrolyte abnormalities, hyperglycemia, etc.) or a greater than 25% increase in the volume of the tumor by MRI scan. If neurologic status deteriorates on a stable or increasing dose of corticosteroids, or if new lesions appear on serial MRI scans, this will also be considered PD."|From the start of treatment until death or progression, median duration of approximately 2 months||||Months||95% Confidence Interval|Median
2631158|NCT01846871|Secondary|Median Overall Survival|Overall survival is measured from the start of treatment until the time of death.|From the start of treatment until the time of death, median duration of approximately 8 months||||Months||95% Confidence Interval|Median
2631159|NCT01846871|Secondary|Number of Participants With Treatment Related Serious Adverse Events|The number of participants with serious adverse events deemed possibly, probably, or definitely related to treatment. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).|From the start of treatment until disease progression, unacceptable toxicity, or death; median duration of approximately 2 months||||Participants|||Count of Participants
2631160|NCT01846871|Primary|Number of Patients Alive and Progression Free After 6 Months|To determine the number of patients with recurrent glioblastoma (GBM) alive and progression free 6 months (PFR6) after start of tivozanib therapy|6 months||||Participants|||Count of Participants
2631161|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Number of Phone Calls to Physician|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of phone calls to physicians.|Up to 18 Month Visit-End of Study|ITT Population|||Phone Calls||Full Range|Median
2631162|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Number of Hours Per Week Caregivers Spent Caring for Patients.|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of hours per week caregivers spent caring for patients.|Up to 18 Month Visit-End of Study|ITT Population|||Hours Per Week||Full Range|Median
2631163|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Days Per Week Patients and Caregivers Could Not Work|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of days per week of missed work because of health reasons.|Up to 18 Month Visit-End of Study|ITT Population|||Days Per Week||Full Range|Median
2631164|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Number of Nights Spent at the Hospital|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of nights spent at the hospital.|Up to 18 Month Visit-End of Study|ITT Population|||Nights||Full Range|Median
2631165|NCT01846741|Secondary|Assess Changes in Healthcare Utilization: Inpatient Hospital Visits, Emergency Room Visits, Outpatient Hospitalizations and Physician Office Visits.|At baseline and each follow-up visit, subjects completed a healthcare utilization questionnaire to report the number of unplanned inpatient hospitalizations, emergency room visits, outpatient hospitalizations, physician office visits.|Up to 18 Month Visit-End of Study|ITT Population|||Visits||Full Range|Median
2631166|NCT01846741|Secondary|Evaluation of Human Factors and Usability of the AspireSR® VNS Therapy® System.|"Usability survey data were collected from all site personnel who used the handheld programmer to evaluate the usability of the AspireSR® VNS Therapy® System.The device usability survey contained 17 questions that measure usability on a five-point Likert scale ranging from Extremely Difficult (5) to Extremely Easy (1). Site personnel were asked to assess usability of the software features, instructions for use, training materials, and overall usability of the system at four different time points. The time points include implant/recovery, the first day of EMU, the end of EMU, and the 6 month follow-up visit.~Overall Usability was calculated as percentage of the users who found the overall usability of system to be easy-2 or extremely easy-1."|Up to 6 Month Visit|ITT Population|||Percentage of Participants Rated 1 or 2|||Number
2631167|NCT01846741|Secondary|Assess All Adverse Events to Outline the Tolerability Profile of the AspireSR® VNS Therapy® System|All adverse events (AEs) occurring during the study were collected and incidence rates tabulated by System Organ Class and Preferred Term utilizing MedDRA version 16.1 dictionary. The incidence profile was used to assess differences in near term tolerability rates relative to standard VNS Therapy.|From initial titration visit (approximately 2 weeks after implantation) up to End of Study|ITT Population|||Number of Participants|||Number
2631168|NCT01846741|Primary|Estimate the Effect Size Associated With Objective Measures and Patient Self-reports of Clinical Outcomes Including Seizure Frequency, Seizure Severity, Seizure Duration, Seizure Intensity, and Post-ictal Duration.|The purpose for determining the effect size was to power a stage 2 study. At the conclusion of stage 1 of the E-37 study, it was determined that another study would not be necessary as it would not provide incremental clinical benefit information above what has already been collected. Therefore, computation of effect size was not necessary.|Up to 18 Month Visit-End of Study|||||||
2631169|NCT01846741|Secondary|Assess Percent Changes in Antiepileptic Drug (AED) Load From Baseline|"AED load were collected and measured from baseline.The AED load is calculated as the sum of all ratios of the total daily dose of each medication taken on the day of the visit over the defined daily dose of the medication for the main indication according to the WHO database.~Positive median value indicates increased drug load."|Up to 18 Month Visit-End of Study|ITT Population|||Percent Change||Full Range|Median
2631171|NCT01846741|Secondary|Assess Changes From Baseline in Quality of Life Based on Patient Completed Questionnaire (QOLIE-31-P)|"Adult subjects (18 years and older) completed the Quality of Life in Epilepsy-Patient-Weighted (QOLIE-31-P) survey questionnaire at screening and safety follow-up visits. The range for QOLIE-31-P (Sub-domains) scale is 0-100. The higher the score the better quality of life.~Mean QOLIE-31-P scores at 3, 6, 12 and 18 months were compared to baseline. MIC Thresholds as defined in Simon Borghs, Christine de la Loge, Joyce A. Cramer, defining minimally important change in QOLIE-31-P scores."|Up to 18 Month Visit-End of Study|ITT Population|||Units on a Scale||Standard Deviation|Mean
2631172|NCT01846741|Secondary|Assess Changes in Seizures Severity, Intensity & Post-Ictal Recovery Based on Patient Completed Questionnaire (SSQ)|"Clinical outcomes such as seizure severity, intensity and post-ictal duration were also assessed during the long-term follow-up visits (3, 6, 12, 18 months) with patient reported questionnaires (SSQ; Seizure Severity Questionnaire). The range for SSQ (all sub-scores) is 1-7 with 1 being the least severe and 7 being the most severe.~Mean SSQ scores at 3, 6, 12 and 18 months were compared to baseline. A change from baseline is calculated as baseline minus follow-up visit score to correspond to the Minimally Important Change (MIC) criteria as defined in the Scoring Scheme for SSQ v2. Questionnaire."|Up to 18 Month Visit-End of Study|ITT Population|||Units on a Scale||Standard Deviation|Mean
2631173|NCT01846741|Secondary|Assesses Changes in Seizure Severity Based on Physician Reported Questionnaire (NHS3)|"Investigators completed the National Hospital Seizure Severity Scale (NHS3) questionnaire at screening, at the end of the EMU stay (provided a seizure occurred during the EMU stay), and at follow‐up visits. Severity was evaluated by seizure type. The range of NHS3 scale is 1-27 with 1 being the least severe and 27 being the most severe.~Negative median value means improvement."|Up to 18 Month Visit-End of Study|ITT Population|||units on a scale||Full Range|Median
2631174|NCT01846741|Secondary|Assess Characterization of Seizures (Duration and Cessation)|Clinical outcomes including seizure duration and cessation were assessed with vEEG during EMU stay. Number of seizures treated with Automatic Stimulation during EMU were evaluated. Of these seizures, those ending during the 60 second course of Automatic Stimulation were assessed and tabulated by seizure type.|Epilepsy Monitoring Unit (EMU) Stay|ITT Population|||Percent of Seizures Ended During Stim|Participants||Number
2631175|NCT01846741|Secondary|Assess Non-seizure Related Stimulation Rate Per Hour During EMU Stay and Stair Stepper Exercise Periods|"Each day in the EMU, subjects exercised for up to 3 minutes stepping up and down at a submaximal effort level on a step stool. Subject's resting heart rate was compared with the calculated 85% of the patient's age-predicted maximum heart rate. This calculated heart rate was then used as termination criteria for the step test.~Non-Seizure Detection Rate (previously known as Potential False Positive Rate) is defined as the total number of non-seizure detections summed for the group divided by the total evaluable monitoring time during the EMU. The non-seizure detection rate per hour was calculated at the various tachycardia detection settings for all subjects during EMU and during exercise activities (stair stepper)."|Epilepsy Monitoring Unit (EMU) Stay|ITT Population. 5 participants analyzed for >=70%, 4 for >=60% setting, 8 for >=50% setting, 2 for >=40% setting, 1 for the >=30% setting.|||detections per hour||95% Confidence Interval|Number
2631176|NCT01846741|Secondary|Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Modeled|"Sensitivity is defined as the total number of seizures detected divided by the total number of seizures during the EMU stay. Data used to support sensitivity analyses included digital ECG/EEG files, corresponding M106 device downloads, and CRF data. Seizure onset times were compared with modeled M106 device detections at the least sensitive setting capable of detecting the seizure based on the corresponding change in heart rate. The participants' surface ECG data collected during the trial and passed through DMSDAT, a validated bench‐top simulant of the Automatic Stimulation feature, was used to produce modeled results for each threshold for AutoStim setting (1;70%, 2;60%, 3;50%, 4;40%, 5;30% and 6;20%). Number of participants is total number of subjects who experienced seizures during the EMU stay.~Bootstrap confidence intervals using 3000 bootstrap samples."|Epilepsy Monitoring Unit (EMU) Stay|ITT Population (Investigator Reported Seizures + Triple Review). N= represents total number of seizures.|||Percent of True Positive Seizures||95% Confidence Interval|Number
2631177|NCT01846741|Secondary|Assess Performance of the Tachycardia Detection Algorithm (Sensitivity) During an EMU Stay Based on ITT Population-Observed|"Sensitivity is defined as the total number of seizures detected divided by the total number of seizures during the EMU stay. Data used to support sensitivity analyses included digital ECG/EEG files, corresponding M106 device downloads, and CRF data. Seizure and non-seizure EEG segments were provided to independent reviewers to confirm seizure occurrence and define electrographic seizure onset times. Seizure onset times were then compared with observed M106 device detections at the least sensitive setting capable of detecting the seizure based on the corresponding change in heart rate. Threshold for AutoStim setting (1;70%, 2;60%, 3;50%, 4;40%, 5;30% and 6;20%). No subjects were assigned to settings 3 and 6 that had seizures with a corresponding heart rate increase of >= 50% and >= 20%, respectively. Number of participants is total number of subjects who experienced seizures during the EMU stay.~Bootstrap confidence intervals using 3000 bootstrap samples."|Epilepsy Monitoring Unit (EMU) Stay|ITT Population (Investigator Reported Seizures + Triple Review). N= represents total number of seizures.|||Percent of True Positive Seizures||95% Confidence Interval|Number
2631178|NCT01846741|Secondary|Summary of Seizures Reported by Investigators and Triple Review|"Seizure events were recorded during the EMU stay (only Automatic Stimulation Mode aka AutoStim ON) using vEEG and ECG to evaluate tachycardia detection algorithm performance. The threshold for the AutoStim feature (20-70%) was programmed for each subject, based upon the historical ictal elevation in heart rate for that subject, requiring the corresponding heart rate elevation above that of a moving baseline window.~Number of seizures observed and reported by investigators during the EMU stay (several subjects had more than one type of seizure) were collected and also reviewed by three (3) independent and blinded reviewers for confirmation. Additionally, the reviewers identified new seizures while reviewing the study EMU stay vEEG."|Epilepsy Monitoring Unit (EMU) Stay|ITT Population: Consists of all patients in the safety population who have any EMU performance recorded data and experienced any seizures.|||Number of Seizures|||Number
2631179|NCT01846728|Secondary|Resting Energy Expenditure|Energy expenditure measured in the resting state|after 3 months of suppression||||kcal||Standard Deviation|Mean
2631180|NCT01846728|Secondary|Fat Free Mass|Fat free mass measured by DXA|Baseline and after 3 mo of suppression||||kg||Standard Deviation|Mean
2631183|NCT01846728|Primary|Brown Adipose Tissue Activity|Brown adipose tissue activity will be measured using Positron Emission Tomography/computer tomography (PET/CT) before and after 3 months of estrogen suppression. Activity is quantified as the standard uptake value (SUV), It is a mathematically derived ratio that is a semiquantitative measure of the tracer uptake in a region of interest that normalizes the lesion activity to the injected activity and a measure of the volume of distribution (usually total body weight or lean body mass).|Baseline and after 3 months of suppression||||Standard uptake value (SUV)||Standard Deviation|Mean
2631184|NCT01846702|Secondary|Number of Participants Developing Anti-LY3084077 Antibodies|The number of participants with 1:4 baseline and postbaseline positive anti-LY3084077 antibody titers.|Pre-dose, Up to Day 190|All randomized participants who received at least one dose of study drug and had evaluable baseline and postbaseline antibody titers.|||participants|||Number
2631185|NCT01846702|Secondary|PD: Change From Baseline to Day 2 in Fasting Glucagon|LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.|Baseline, Up to Day 2|All randomized participants who received at least one dose of study drug and have evaluable fasting glucagon data.|||pmol/L||Standard Error|Least Squares Mean
2631186|NCT01846702|Secondary|PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal|LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.|Baseline, Day 2|All randomized participants who received at least one dose of study drug and had evaluable incremental glucose AUC before and after a standard meal data.|||millomole*hour/Liter (mmol*h/L)||Standard Error|Least Squares Mean
2631187|NCT01846702|Secondary|PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal|LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.|Baseline, Day 2|All randomized participants who received at least one dose of study drug and had evaluable C-peptide AUC before and after a standard meal data.|||picomole*hour/Liter (pmol*h/L)||Standard Error|Least Squares Mean
2631188|NCT01846702|Secondary|PD: Change From Baseline in Weight||Baseline, Up to Day 15|Zero participants had weight measured and therefore change from baseline in weight was not calculable across all arms.||||||
2631189|NCT01846702|Secondary|PD: Change From Baseline in Fasting Insulin|LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.|Baseline, Up to Day 15|All randomized participants who received at least one dose of study drug and had evaluable fasting insulin data.|||picomole/Liter (pmol/L)||Standard Error|Least Squares Mean
2631190|NCT01846702|Secondary|Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides|Percent change=(measure at time t-measure at baseline)/measure at baseline*100%). Least Square Means (LS means) were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.|Baseline, Up to Day 15|All randomized participants who received at least one dose of study drug and had evaluable fasting triglycerides data.|||percent||Standard Deviation|Least Squares Mean
2631191|NCT01846702|Secondary|PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077||Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||microgram/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2631192|NCT01846702|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077||Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||microgram*hour/milliliter (μg•hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2631193|NCT01846702|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|Pre-dose, Up to Day 190|All randomized participants who received at least one dose of study drug.|||participants|||Number
2631194|NCT01846624|Secondary|Overall Survival (OS)|Survival is reported as the number and proportion of participants that received midostaurin who remained alive 2 years after starting midostaurin treatment.|Up to 2 years|Only participants that started midostaurin therapy are included in the overall survival assessment.|||Participants|||Count of Participants
2631195|NCT01846624|Secondary|Progression-free Survival (PFS)|"Progression-free survival (PFS) is reported as the number and proportion of participants who did not receive hematopoietic cell transplantation, and who did not experience disease progression or death for any reason within 2 years after starting midostaurin treatment.~Progressive disease: Bone marrow blasts ≥ 5%; or reappearance of blasts in the blood; or development of extramedullary disease."|Up to 2 years|Only participants that started midostaurin therapy, and did not withdraw for hematopoietic cell transplantation, are included in the progression-free survival assessment.|||Participants|||Count of Participants
2631205|NCT01846507|Secondary|Change From Baseline Menses for Participant Perceived Limitation of Social or Leisure Activities|Menorrhagia Impact Questionnaire (MIQ): Question 4 - participant perceived limitation of social or leisure during most recent menses. Scale ranges from a score of 1 to 5 (with 1 being social or leisure activities not at all limited and 5 being social or leisure activities limited extremely). Lower values indicate a better outcome (less limitation of social or leisure activities). Unit of measure is scores on a scale.|Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid||||score on a scale||Full Range|Mean
2631278|NCT01846221|Secondary|Maternal Systolic Blood Pressure|Blood pressure will be measured at different timepoints.|Baseline, 30 Minutes post epidural administration|46 out of 47 participants were included from the Clonidine group due to 1 participant did not have blood pressure taken at 30 minutes. 48 out of 51 participants were included from the Fentanyl group due to 3 participants did not have blood pressure taken at 30 minutes.|||mm Hg||Full Range|Mean
2631196|NCT01846624|Secondary|Median Duration of Response (DoR)|"Response was assessed by evaluations conducted every 3 cycles (12 weeks). Once documented as partial response (PR), complete response (CR), or complete response with incomplete blood count recover (CRi), response status was confirmed every 12 weeks. In responding participants, duration of response was assessed from the start of treatment through the last documented response before documented progressive disease or death. The outcome is reported as the median value for duration of response, with full range.~CR: Bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; ANC > 1000/μL; platelet > 100,000/μL; independence of red cell transfusions.~CRi: All CR criteria except ANC < 1000/μL or platelet count < 100,000/μL.~PR: All hematologic criteria of CR; except decrease of bone marrow blast percentage to 5% to 25%; & decrease of pretreatment bone marrow blast percentage by at least 50%."|Up to 1 year|Does not include participants who did not achieve a documented clinical response. Participants who withdrew to receive hematopoietic cell transplant (HCT) are censored at the last assessment of response prior to HCT.|||weeks||Full Range|Median
2631197|NCT01846624|Secondary|Overall Response Rate (ORR)|"Overall response rate (ORR) was assessed as the number and proportion of participants who received midostaurin and achieved a partial response (PR), complete response (CR), or complete response with incomplete blood count recovery (CRi).~Complete remission (CR): Bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) > 1000/μL; platelet count > 100,000/μL; independence of red cell transfusions.~CR with incomplete recovery (CRi): All CR criteria except for ANC < 1000/μL or platelet count < 100,000/μL.~Partial remission (PR): All hematologic criteria of CR; except decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%."|up to 1 year|Only participants that started midostaurin therapy are included in the response assessment.|||Participants|||Count of Participants
2631198|NCT01846624|Primary|Complete Remission (CR) Rate|"The complete remission (CR) rate, or complete response rate, is reported as the sum and proportion of participants that achieved CR or CR with incomplete blood count recovery (CRi), within 12 months of starting midostaurin treatment.~Complete remission (CR): Bone marrow blasts < 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) > 1000/μL; platelet count > 100,000/μL; independence of red cell transfusions.~CR with incomplete recovery (CRi): All CR criteria except for ANC < 1000/μL or platelet count < 100,000/μL.~Partial remission (PR): All hematologic criteria of CR; except decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%."|Up to 1 year|Only participants that started midostaurin therapy are included in the complete response assessment.|||Participants|||Count of Participants
2631199|NCT01846611|Secondary|Objective Response Rate (ORR)|ORR is defined as the percentage of participants with measurable disease achieving a best overall response of either complete response (CR) or partial response (PR) based on RECIST. CR: disappearance of all target and non-target lesions and normalization of tumor marker levels in non-target lesions. PR: at least a 30 percent (%) decrease in the sum of longest diameter (LD) of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|Up to 4.3 years|All randomized analysis set included all participants who were randomized to study treatment independent of whether they received study drug.|||Percentage of participants||95% Confidence Interval|Number
2631200|NCT01846611|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time between the date of randomization and the date of disease progression or death. PFS was assessed using the response evaluation criteria in solid tumors (RECIST) Version 1.1. As per criteria progressive disease in case of target lesions means at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Progressive disease in case of non-target lesions means unequivocal progression of existing non-target lesions. In both cases the appearance of one or more new lesions is also considered progression.|Up to 4.3 years|All randomized analysis set included all participants who were randomized to study treatment independent of whether they received study drug.|||months||95% Confidence Interval|Median
2631201|NCT01846611|Primary|Overall Survival (OS)|OS is defined as the time between the date of randomization and the date of death. Participants who died, regardless of the cause of death, were considered to have had an event.|Up to 4.3 years|All randomized analysis set included all participants who were randomized to study treatment independent of whether they received study drug.|||months||95% Confidence Interval|Median
2631202|NCT01846507|Secondary|Change From Baseline Menses for Ferritin Lab Value|Ferritin lab value normal range is 7 ng/mL to 142 ng/mL. Values in the range of 7ng/mL to 142 ng/mL would be considered normal Ferritin values. A score lower than the normal range (below 7 ng/mL) would indicate a worse outcome. Unit of measure is ng/mL.|Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid||||ng/dL||Full Range|Mean
2631203|NCT01846507|Secondary|Change From Baseline Menses for Hemoglobin Lab Value|Hemoglobin lab value normal range is 12 g/dL to 16 g/dL. Values in the range of 12 g/dL to 16 g/dL would be considered normal Hemoglobin values. A score lower than the normal range (below 12 g/dL) would indicate a worse outcome. Unit of measure is g/dL.|Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid||||gm/dL||Full Range|Mean
2631204|NCT01846507|Secondary|Change From Baseline Menses for Menstrual Blood Loss as Measured by Pictorial Blood Assessment Chart (PBAC) Scores|Pictorial Blood Assessment Chart (PBAC) scores - participant assessment of menstrual blood loss during menses using a pictorial chart to score menstrual blood loss. Pictorial scores range from 1 point for mild soaking of a pad/tampon, 5 points for moderate soaking of a pad/tampon, 10 points for severe soaking of a pad/tampon, and 5 points for each episode of flooding and for each blood clot larger than a quarter in size. Lower values indicate a better outcome (less blood loss). Unit of measure is a total computed score (all points during the menses from the pictorial chart added together).|Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid||||score on a scale||Full Range|Mean
2631245|NCT01846299|Secondary|Number of Participants With Ranibizumab Treatments|The number of participants administered study treatments, according to treatment frequency, was assessed.|Month 12|The safety set was used for this analysis. The safety set included randomized participants who received at least one dose of study treatment. Two participants from the sham group were included in the ranibizumab group based on the actual treatment received.|||Participants|||Number
2631206|NCT01846507|Secondary|Change From Baseline Menses for Participant Perceived Limitation in Physical Activities|Menorrhagia Impact Questionnaire (MIQ): Question 3 - participant perceived limitation in physical activities during most recent menses. Scale ranges from a score of 1 to 5 (with 1 being physical activities not at all limited and 5 being physical activities extremely limited). Lower values indicate a better outcome (less limitation of physical activities). Unit of measure is scores on a scale.|Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid||||score on a scale||Full Range|Mean
2631207|NCT01846507|Secondary|Change From Baseline Menses for Participant Perceived Limitation of School Attendance|Menorrhagia Impact Questionnaire (MIQ): Question 2 - participant perceived limitation of school attendance during most recent menses. Scale ranges from a score of 1 to 5 (with 1 being school attendance not at all limited and 5 being school attendance limited extremely). Lower values indicate a better outcome (less limitation of school attendance). Unit of measure is scores on a scale.|Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid||||score on a scale||Full Range|Mean
2631208|NCT01846507|Primary|Change From Baseline Menses for Participant Perceived Blood Loss|Menorrhagia Impact Questionnaire (MIQ): Question 1 - participant perceived blood loss during most recent menses. Scale ranges from a score of 1 to 4 (with 1 being light blood loss and 4 being very heavy blood loss). Lower values indicate a better outcome (less blood loss during menses). Unit of measure is scores on a scale.|Baseline menses (no treatment) and 3 menstrual cycles treated with tranexamic acid||||score on a scale||Full Range|Mean
2631209|NCT01846494|Secondary|Composite of Death and Cardiovascular and Renal Dysfunction|Reported as percentage of participants experiencing one or more of the following endpoints: all-cause mortality, rehospitalization for cardiac/renal cause, increase in BNP to >100 or doubling from baseline, new onset of LVEF <50%, new onset of eGFR <60% or >= 25% reduction from baseline.|5 years||||percentage of participants|||Number
2631210|NCT01846494|Primary|Number of Participants Who Experienced Death or Rehospitalization Due to Cardiovascular or Renal Cause||5 years|Only subjects who were assessed at least once for each component of the composite endpoint were included for analysis.|||Participants|||Count of Participants
2631211|NCT01846455|Primary|Apparent Volume of Distribution During Terminal Phase (Vz/F) of Buprenorphine and Naloxone|Apparent volume of distribution during terminal phase (only for buprenorphine and naloxone), calculated as Dose/(λz • AUC0-inf).|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2631212|NCT01846455|Primary|Apparent Body Clearance (CL/F) of Buprenorphine and Naloxone|Apparent body clearance (only for buprenorphine and naloxone), calculated as Dose/AUC0-inf.|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2631213|NCT01846455|Primary|Terminal Elimination Half-life (t1/2) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|Terminal elimination half-life, calculated as ln(2)/λz. The terminal phase elimination half-life was calculated over a period of at least 2 half-lives.|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||hours||Geometric Coefficient of Variation|Geometric Mean
2631214|NCT01846455|Primary|Terminal Phase Elimination Rate-Constant (λz) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|For the determination of λz, only those data points judged to describe the terminal log-linear decline resulting in an adjusted coefficient of determination value (R2) > 0.7 were used in the regression. A minimum of 3 data points were used in calculating λz.|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||1/hour||Geometric Coefficient of Variation|Geometric Mean
2631215|NCT01846455|Primary|Percentage of Area Under the Concentration-time Curve From Time Zero to Infinity Due to Extrapolation (%AUCextrap) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|"Calculated as:~(AUC0-inf - AUC0-last)/AUC0-inf * 100~AUC0-inf, apparent body clearance (CL/F), and apparent volume of distribution during terminal phase (Vz/F) would not have been reported if %AUCextrap was > 20%."|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||percentage of AUC0-inf||Standard Deviation|Mean
2631216|NCT01846455|Primary|Time of the Last Measureable Plasma Concentration (Tlast) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide||before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||hours||Full Range|Median
2631867|NCT01840943|Secondary|Maximum Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.||||||
2631217|NCT01846455|Primary|Time to Reach the Maximum Plasma Concentration (Tmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide||before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||hours||Full Range|Median
2631218|NCT01846455|Primary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|"The extrapolation to infinity was done using the terminal phase.~AUC0-inf = AUC0-last + Ct/λz~Where Ct was the last observed quantifiable concentration and λz was the apparent terminal phase elimination rate constant."|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2631219|NCT01846455|Primary|Maximum Observed Plasma Concentration (Cmax) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide||before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2631220|NCT01846455|Primary|Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last) of Buprenorphine, Norbuprenorphine, Naloxone and Naloxone-3-β-D-Glucuronide|"AUC0-last was calculated for buprenorphine, norbuprenorphine, naloxone, and naloxone-3-β-D-glucuronide using non-compartmental analysis:~AUC0-last = AUC from time 0 to the time of the last measurable plasma concentration, calculated using the linear trapezoidal rule."|before dosing (time 0; Baseline) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours after dosing|The PK population included participants without any major protocol deviations who contributed PK samples and had sufficient evaluable data for the calculation of PK parameters. Eight enrolled participants were excluded due to emesis observed within 4 hours postdose, and two due to protocol violations.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2631221|NCT01846442|Secondary|Change From Baseline to Week 12 of Vaginal Color|To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Mean
2631222|NCT01846442|Secondary|Change From Baseline to Week 12 of Vaginal Epithelial Surface Thickness|To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal epithelial surface thickness(one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Mean
2631223|NCT01846442|Secondary|Change From Baseline to Week 12 of Vaginal Epithelial Integrity|To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Mean
2631224|NCT01846442|Secondary|Change From Baseline to Week 12 of Vaginal Secretions|To evaluate the aspect of the vaginal mucosa and the local tolerance to DHEA suppository, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on the ITT Population defined as all treated subjects (who received at least one dose) with a baseline and at least one post-baseline efficacy assessment.|||units on a scale||Standard Error|Mean
2631225|NCT01846442|Primary|Co-primary Endpoint: Change From Baseline to Week 12 of Self-assessment of the Most Bothersome Symptom Dyspareunia|The severity of dyspareunia was evaluated by a questionnaire. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe dyspareunia as their Most Bothersome Symptom of vulvovaginal atrophy (VVA) and had ≤ 5% of Superficial Cells and a vaginal pH > 5 on Day 1.|||units on a scale||Standard Error|Mean
2631279|NCT01846221|Primary|Number of Subjects With Success Rate at 15 Minutes Post-epidural Bolus Injection|Pain Visual Analogue Scale (VAS) was evaluated every 5 min for 15 min. 'Success' is defined as at least a 4-point reduction in VAS at 15 min. (0=no pain, 10= worst pain)|Baseline, 15 Minutes post epidural administration|3 subjects in the Clonidine group were not included in the analysis due to the following reasons: 2 catheter failures, 1 age exclusion.|||Participants|||Count of Participants
2631226|NCT01846442|Primary|Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal pH.|A pH strip was applied directly to the lateral wall of the vagina using forceps. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe pain at intercourse (Dyspareunia) as their Most Bothersome Symptom of VVA and had ≤ 5% of Superficial Cells and a vaginal pH > 5 on Day 1.|||pH||Standard Error|Mean
2631227|NCT01846442|Primary|Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Superficial Cells)|The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe pain at intercourse (Dyspareunia) as their Most Bothersome Symptom of VVA and had ≤ 5% of Superficial Cells and a vaginal pH > 5 on Day 1.|||percentage of superficial cells||Standard Error|Mean
2631228|NCT01846442|Primary|Co-primary Endpoint: Change From Baseline to Week 12 of Vaginal Cell Maturation (Percentage of Parabasal Cells)|The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|The analysis was performed on a subgroup of the ITT Population (defined as all treated subjects with a baseline and at least one post-baseline efficacy assessment) who had self-identified moderate/severe pain at intercourse (Dyspareunia) as their Most Bothersome Symptom of VVA and had ≤ 5% of Superficial Cells and a vaginal pH > 5 on Day 1.|||percentage of parabasal cells||Standard Error|Mean
2631229|NCT01846416|Secondary|Minimum Plasma Concentration (Cmin) for Atezolizumab||Pre-dose (0 hour) on Day 1 of Cycles 2, 3, 4, 8, and 16|Pharmacokinetic- evaluable population. Here, Number of participants analyzed = number of participants with available data for this outcome, and n= number of participants with available data at the specified time point. Per planned analysis, pharmacokinetic data were not analyzed separately for each cohort.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2631230|NCT01846416|Secondary|Maximum Plasma Concentration (Cmax) for Atezolizumab||Pre-dose (0 hour) and 30 minutes after infusion on Day 1 of Cycle 1|Pharmacokinetic- evaluable population: All treated participants with pharmacokinetic data at specified time points. Here, Number of participants analyzed = number of participants with available data for this outcome. Per planned analysis, pharmacokinetic data were not analyzed separately for each cohort.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2631231|NCT01846416|Secondary|Overall Survival (OS)|OS was defined as the time from first dose of the study drug to the time of death from any cause of the study. Participants who were still alive at the time of analysis were censored at the time of their last study assessment (for active participants) or at the last date known alive (for participants in follow-up). If no post-baseline data were available, OS was censored at the date of first treatment plus 1 day.|Baseline till death or up to 20 months, whichever occurred first|Efficacy-evaluable population.|||months||95% Confidence Interval|Median
2631232|NCT01846416|Secondary|Percentage of Participants With Death|Participants were followed for survival throughout the study.|Baseline till death or up to 20 months, whichever occurred first|Efficacy-evaluable population.|||percentage of participants|||Number
2631233|NCT01846416|Secondary|Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to Modified RECIST|Percentage of participants who were progression free at Months 6 and 12 (according to modified RECIST). For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started.|Months 6, 12 and 30|Efficacy-evaluable population.|||percentage of participants|||Number
2631234|NCT01846416|Secondary|PFS According to Modified RECIST|PFS according to modified RECIST was defined as time from first dose of atezolizumab to first occurrence of documented disease progression or death due to any cause, as determined by investigator for participants who discontinued at first documented radiographic progression. For participants who continued beyond first documented progression and had follow-up tumor assessment or death, PFS was defined as time from first dose of atezolizumab to subsequent radiographic progression or death. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment.|Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)|Efficacy-evaluable population.|||months||Full Range|Median
2631235|NCT01846416|Secondary|Percentage of Participants With Disease Progression or Death According to Modified RECIST|For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started.|Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)|Efficacy-evaluable population.|||percentage of participants|||Number
2631236|NCT01846416|Secondary|Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to RECIST v1.1|Percentage of participants who were progression free at Month 6 and 12 (based on RECIST v1.1) was reported. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Months 6, 12 and 30|Efficacy-evaluable population.|||percentage of participants|||Number
2631280|NCT01846208|Other Pre-specified|Changes in Egg-specific Mechanistic Measures and Skin Prick Test Results.|Changes in egg-specific IgE and IgG4, changes in SPT mean wheal diameters, basophil reactivity, Th2 and Treg values.|2 Years|Data not reported because these are for tertiary objectives that are exploratory.||||||
2631237|NCT01846416|Secondary|Progression-Free Survival (PFS) According to RECIST v1.1|PFS was defined as time from randomization to first occurrence of documented disease progression (based on RECIST v1.1 criteria) or death due to any cause within 30 days of the last treatment, whichever occurs earlier as determined by investigator. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment. Participants with no post-baseline tumor assessments were censored at the time of first dose plus 1 day.|Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)|Efficacy-evaluable population.|||months||Full Range|Median
2631238|NCT01846416|Secondary|Percentage of Participants With Disease Progression or Death According to RECIST v1.1|For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)|Efficacy-evaluable population.|||percentage of participants|||Number
2631239|NCT01846416|Secondary|Percentage of Participants With 6-Month Duration of Objective Response|Duration of objective response at 6 months was defined as time from initial occurrence of documented CR or PR until Month 6. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants were censored at the date of last tumor assessment.|Month 6|Efficacy-evaluable population with a confirmed objective response.|||percentage of participants|||Number
2631240|NCT01846416|Secondary|Duration of Objective Response According to RECIST v1.1|Duration of objective response was defined as time from initial occurrence of documented CR or PR until documented disease progression (using RECIST v1.1 as determined by investigator) or death, whichever occurred first. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. Progressive disease was at least a 20% increase in sum of diameters of TLs, taking as reference smallest sum on study (nadir). For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants were censored at the date of last tumor assessment.|Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)|Efficacy-evaluable population with a confirmed objective response.|||months||Full Range|Median
2631241|NCT01846416|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 (v1.1)|Objective response was defined as a CR or PR, as determined by the investigator according to RECIST v1.1. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameter of TLs, taking as reference the baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants not meeting these criteria, including participants without at least 1 post-baseline response assessment were considered as non-responders.|Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)|Efficacy-evaluable population.|||percentage of participants||95% Confidence Interval|Number
2631242|NCT01846416|Primary|Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST)|Objective response was defined as a complete response (CR) or partial response (PR), as determined by investigator according to modified RECIST criteria. Modified RECIST was derived from RECIST v1.1 conventions and immune related response criteria. CR was defined as disappearance of all tumor lesions (target lesion [TL] and non-target lesion [non-TL]) and no new measurable or unmeasurable lesions, all lymph node short axes must be less than 10 millimeters (mm), and PR was defined as at least 30 percent (%) decrease in sum of diameter of TLs and all new measurable lesions since baseline in absence of CR, and both confirmed by consecutive assessment greater than or equal to 4 weeks from date first documented. Participants not meeting these criteria, including participants without at least one post-baseline response assessment were considered as non-responders.|Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)|Efficacy-evaluable population; all treated participants who received at least 1 dose of atezolizumab during study.|||percentage of participants||95% Confidence Interval|Number
2631243|NCT01846299|Secondary|Number of Primary Reasons for Decision to Treat by Investigator|The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.|12 months|The safety set was used for this analysis. The safety set included randomized participants who received at least one dose of study treatment. Two participants from the sham group were included in the ranibizumab group based on the actual treatment received.|||Number of primary reasons|Participants||Number
2631244|NCT01846299|Secondary|Number of Participants With Re-treatments|The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to Month 12, the maximum number of retreatments was 5.|Month 6, month 12|The safety set was used for this analysis. The safety set included randomized participants who received at least one dose of study treatment. Two participants from the sham group were included in the ranibizumab group based on the actual treatment received.|||Participants|||Number
2631297|NCT01845831|Secondary|Acute Renal Failure Rate|Acute renal failure is defined as a clinical diagnosis of acute renal failure with documented new-onset abnormal renal function (increment > 0.5 mg/dL from baseline).|Duration of Hospitalization (Up to 10 Days)||||participants|||Number
2631246|NCT01846299|Secondary|Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss|VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.|Month 2, Month 6, Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.|||Participants|||Number
2631247|NCT01846299|Secondary|Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters|VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.|Month 2, Month 6 , Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.|||Participants|||Number
2631248|NCT01846299|Secondary|Average Change From Baseline in BCVA|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.|Baseline (BL), month 1 through month 6, month 1 through month 12|The FAS was used for this analysis. The FAS included randomized participants who received at least one dose of study medication.|||letters||Standard Deviation|Mean
2631249|NCT01846299|Secondary|Number of Participants Requiring Rescue Treatment at Month 1|Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of > 5 letters due to disease activity from baseline to Month 1.|Month 1|The FAS was used for this analysis. The FAS included all randomized participants who received at least one dose of study treatment.|||Participants|||Number
2631250|NCT01846299|Secondary|Number of Participants With Presence of Active Macular Edema (ME) Leakage|The presence of active ME leakage was assessed by fluorescein angiography (FA).|Month 2|The FAS was used this analysis. The FAS included randomized participants who received at least one dose of study treatment.|||Participants|||Number
2631251|NCT01846299|Secondary|Number of Participants With Presence or Absence of Subretinal Fluid in Study Eye Compared to Baseline|The presence of subretinal fluid was assessed by OCT.|Month 2, Month 6, Month 12|The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.|||Participants|||Number
2631252|NCT01846299|Secondary|Number of Participants With Presence or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline|The presence of intra-retinal fluid was assessed by OCT.|Month 2, Month 6, Month 12|The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.|||Participants|||Number
2631253|NCT01846299|Secondary|Change From Baseline in Central Subfield Volume (CSFV) in Study Eye|CSFV was assessed OCT. A negative change from baseline indicates improvement.|Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|The full analysis set (FAS) was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.|||microliters (ul)||Standard Deviation|Mean
2631254|NCT01846299|Secondary|Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye|CSFT wasassessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|The full analysis set (FAS) was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.|||micrometers (um)||Standard Deviation|Mean
2631255|NCT01846299|Secondary|Change From Baseline in BCVA in Study Eye up to Month 2|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.|Baseline, Month 1, Month 2|The full analysis set (FAS) was considered for the analysis. The FAS. The FAS included all randomized participants who received at least one dose of study treatment. Only participants of the FAS, who had data at baseline and the specific post-baseline time point, were included in the analysis for that time point.|||letters||Standard Error|Least Squares Mean
2631256|NCT01846299|Primary|Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.|Baseline, Month 2|Full analysis set: The full analysis set included all randomized participants who received at least one dose of study treatment.|||letters||Standard Error|Least Squares Mean
2631257|NCT01846273|Secondary|Number of Non-Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class|Reported categorically: Mild, Moderate, Severe|Up to Month 24|Safety Analysis Set|||Adverse Events|||Number
2631258|NCT01846273|Secondary|Number of Ocular Adverse Events of the Study Eye Regardless of Study Drug Relationship up to Month 24, Any Primary System Organ Class|Reported categorically: Mild, Moderate, Severe|Up to Month 24|Safety Analysis Set|||Adverse Events|||Number
2631274|NCT01846273|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 - Study Eye|Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.|Baseline, Month 12|Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data|||Letters||Standard Error|Least Squares Mean
2631259|NCT01846273|Secondary|Mean Change From Baseline in Composite Scores, National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) at Months 3, 12 and 24|The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure a patient's subjective assessment of vision-related quality of life at Months 3, 12 and 24. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated poorer function.|Baseline, Month 3, Month 12, Month 24|All patients with a value for both baseline and the specific post-baseline visit. The baseline value is the last available, non-missing, value collected prior to first study treatment in the study eye.|||Unit of scales||Standard Deviation|Least Squares Mean
2631260|NCT01846273|Secondary|Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 24||Month 3, Month 24|Safety Analysis Set|||injections|||Number
2631261|NCT01846273|Secondary|Total Number of Ranibizumab Injections Received in the Study Eye From Month 3 to Month 12||Month 3, Month 12|Safety Analysis Set|||injections|||Number
2631262|NCT01846273|Secondary|Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 24||Baseline, Month 24|Safety Analysis Set|||injections|||Number
2631263|NCT01846273|Secondary|Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 24||Baseline, Month 24|Safety Analysis Set|||injections|||Number
2631264|NCT01846273|Secondary|Total Number of Verteporfin/Sham PDT Injections Received in the Study Eye Prior to Month 12||Baseline, Month 12|Safety Analysis Set|||injections|||Number
2631265|NCT01846273|Secondary|Total Number of Ranibizumab Injections Received in the Study Eye Prior to Month 12||Baseline, Month 12|Safety Analysis Set|||injections|||Number
2631266|NCT01846273|Secondary|Mean Change From Baseline in Investigator-Assessed Central Subfield Retinal Thickness (CSFT) at Month 24 - Study Eye|The thickness of the retina was measured using Spectral Domain (SD) optical coherence tomography (OCT) equipment (SD-OCT) and reported as a difference, in micrometers. A negative number indicates a reduction in thickness, whereas a positive number indicates an increase. An increase in thickness may indicate a progression of the underlying disease.|Baseline, Month 24|All patients with a value at baseline and at Month 24|||Micrometers||Standard Error|Least Squares Mean
2631267|NCT01846273|Secondary|Percentage of Patients With Presence of Leakage at Month 6, Month 12 and Month 24 - Study Eye|Presence of lesion leakage was based on Fluorescein Angiography (FA) as assessed by the Central Reading Center (CRC). The presence of leakage may lead to disease progression and worsening vision.|Month 6, Month 12 and Month 24|All patients who attended the specific visit|||Percentage of participants|||Number
2631268|NCT01846273|Secondary|Percentage of Patients With Complete Polyp Regression at Months 6 and 24 - Study Eye|"Polyp regression was based on the Indocyanine green angiography (ICGA) assessment by the Central Reading Center (CRC). A patient was considered to have complete polyp regression if the presence of polyps, as assessed by CRC, had value No. Polyp regression which may lead to disease stabilization and consequently better vision."|Month 6, Month 24|All patients who attended the specific visit|||Percentage of participants|||Number
2631269|NCT01846273|Secondary|Change in BCVA at Month 12 and 24 Compared to the Time Point of First Ranibizumab Treatment Interruption|Best Corrected Visual Acuity (BCVA) was assessed using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 4 meters.|Month 3, Month 12, Month 24|Prior to DB lock, the statistical analysis plan was amended and this endpoint was removed (initially included in order to assess VA maintenance during the PRN phase after the loading phase of ranibizumab 0.5 mg). When SAP was finalized, this question had already been addressed (CRF002A2413 (NCT01775124), FVF4579g (NCT00891735)): no data collected.||||||
2631270|NCT01846273|Secondary|Maintenance of BCVA (Within 5 Letter Change) at Month 12 and 24 Compared to BCVA at the Time Point of First Ranibizumab Treatment Interruption|Best Corrected Visual Acuity (BCVA) was assessed using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 4 meters.|Month 3, Month 12, Month 24|Prior to DB lock, the statistical analysis plan was amended and this endpoint was removed (initially included in order to assess VA maintenance during the PRN phase after the loading phase of ranibizumab 0.5 mg). When SAP was finalized, this question had already been addressed (CRF002A2413 (NCT01775124), FVF4579g (NCT00891735)): no data collected.||||||
2631271|NCT01846273|Secondary|Percentage of Patients With BCVA (Letters) Change From Baseline at Month 24 - Study Eye|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20.|Baseline, Month 24|All participants with a BCVA value for both Baseline and Month 24.|||Percentage of participants|||Number
2631272|NCT01846273|Secondary|Mean Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Month 24 - Study Eye|Best Corrected Visual Acuity (BCVA) was assessed during all study visits using best correction determined from protocol refraction at a starting test distance of 4 meters. VA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a starting test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient, hence an increase in score indicates improvement in acuity.|Baseline, Month 24|All patients with a BCVA value for both baseline and Month 24|||Letters||Standard Error|Least Squares Mean
2631273|NCT01846273|Primary|Number of Patients With Complete Polyp Regression From Baseline at Month 12 - Study Eye|"Polyp regression was based on the Indocyanine green angiography (ICGA) assessment by the Central Reading Center (CRC). A patient was considered to have complete polyp regression if the presence of polyps, as assessed by CRC, had value No. Polyp regression which may lead to disease stabilization and consequently better vision."|Baseline, Month 12|Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data|||Participants|||Number
2631275|NCT01846221|Secondary|Number of Spontaneous Vaginal Deliveries|Mode of delivery: spontaneous vaginal or instrumental vaginal versus cesarean.|Upon delivery (approximately up to 8 hours from baseline)||||spontaneous vaginal deliveries|||Number
2631281|NCT01846208|Secondary|Number of Participants With Unrestricted Consumption of Unbaked Egg|Number of participants who reported consumption of concentrated (unbaked) egg in their diet on the long-term follow-up questionnaire 3 years after randomization, indicating unrestricted consumption of unbaked egg. This is a qualitative questionnaire asking participants about egg in their diet, symptoms, and what treatment they received for their allergic reactions.|3 years after randomization|Participants who completed the long term follow-up questionnaire 3 years after randomization are included.|||Participants|||Count of Participants
2631282|NCT01846208|Secondary|Incidence of All Serious Adverse Events|"Incidence of all serious adverse events during the study.~No statistical analyses were performed since there were no events in 2 of the 3 treatment groups and only 1 event in the third so it would not be meaningful."|up to 3 years|All treated participants|||Participants|||Count of Participants
2631283|NCT01846208|Secondary|Desensitization to >= 4.444 Grams Egg White Solid.|Development of desensitization to able to successfully consume >=4444 mg egg white protein during a desensitization OFC on therapy at 1 year and 2 years.|1 Year and 2 Years||||Participants|||Count of Participants
2631284|NCT01846208|Primary|Sustained Unresponsiveness to Egg Consumption at 2 Years.|Sustained unresponsiveness - able to successfully consume 7444 mg egg white protein in a desensitization OFC and, after an 8-10 week egg-free interval, were also able to successfully consume 7444 mg egg white protein in an OFC after up to 2 years of therapy.|2 Years|All treated participants were included in the analysis.|||Participants|||Count of Participants
2631285|NCT01846104|Secondary|Number of Subjects Who Developed TNA Anti-ricin Toxin-neutralizing Antibody Titers (≥ 1:50)||Six months|All statistical analysis of immunogenicity data was conducted using 4 subjects at every time point except Day 84 and 180 (for which there were 3 subjects).|||participants|||Number
2631286|NCT01846104|Secondary|Number of Subjects Who Developed Total ELISA IgG Titers (≥ 1:500)||Six months|All statistical analysis of immunogenicity data was conducted using 4 subjects at every time point except Day 84 and 180 (for which there were 3 subjects).|||Subjects with Total ELISA IgG (≥ 1:500)|||Number
2631287|NCT01846104|Primary|Number of Vaccinated Participants Who Experienced Adverse Events by Nature and Severity.||Six months|All statistical analysis of safety data was conducted using 4 subjects at every time point except Day 180 (for which there were 3 subjects).|||participants|||Number
2631288|NCT01846039|Secondary|Percentage of Participants Who Would Recommend VOLUMA Treatment of the Nose to Others||Days 113, 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.|||percentage of participants|||Number
2631289|NCT01846039|Secondary|Percentage of Participants Satisfied or Very Satisfied Based on the Treatment Satisfaction Scale (TSS)|Participants assessed their satisfaction with the study drug (VOLUMA) treatment at Days 113, 239 and 421 using the TSS 5-point scale: -2 (very dissatisfied) to 2 (very satisfied). The percentage of participants satisfied or very satisfied with study drug treatment is reported.|Days 113, 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.|||percentage of participants|||Number
2631290|NCT01846039|Secondary|Percentage of Participants Satisfied or Very Satisfied Based on the Nose Satisfaction Scale (NSS)|Participants assessed their satisfaction with the appearance of their nose at Days 113, 239 and 421 using the NSS 5-point scale: -2 (very dissatisfied) to 2 (very satisfied). The percentage of participants who rated themselves as satisfied or very satisfied is reported.|Days 113, 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.|||percentage of participants|||Number
2631291|NCT01846039|Secondary|Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient|The participant evaluated the improvement of their nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Days 239 and 421. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported|Baseline, Days 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.|||percentage of participants|||Number
2631292|NCT01846039|Secondary|Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Central Evaluating Physician|The independent central evaluating physician evaluated the improvement of the participant's nose compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Days 239 and 421. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported.|Baseline, Days 239 and 421|Intent-to-treat population included all enrolled participants who received treatment.|||percentage of participants|||Number
2631293|NCT01846039|Primary|Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient at Day 113|The participant evaluated the improvement of their nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Day 113. The percentage of participants with a ≥ 1 Grade Improvement from Baseline is reported.|Baseline, Day 113|Intent-to-treat population included all enrolled participants who received treatment.|||percentage of participants|||Number
2631294|NCT01846039|Primary|Percentage of Participants With a ≥ 1 Grade Improvement on the Assessment of Aesthetic Improvement Scale (AAIS) as Assessed by the Central Evaluating Physician at Day 113|The independent central evaluating physician evaluated the improvement of the participant's nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Day 113. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported.|Baseline, Day 113|Intent-to-treat population included all enrolled participants who received treatment.|||percentage of participants|||Number
2631295|NCT01845974|Primary|Number of Participants With Hemodynamic, Electrolyte, and Electrophysiologic Derangements|The objective of this pilot study is to investigate the use of a lower flow catheter (ThermoCool® SF NAV Catheter, Biosense Webster, Inc. Diamond Bar, CA, eluting 8-15ml/minute during RF lesion delivery) vs. a higher flow catheter (ThermoCool® catheter, same manufacturer, eluting 17-30 ml/minute), Outcomes are measured by number of Participants with Hemodynamic, Electrolyte, and Electrophysiologic Derangements, is reported. This was measured as participants requiring electrolyte replacement, if the BP dropped below 100 mm in CICU or if participants sustained atrial tachyarrhythmias|Observation period is up to the 24 hours post procedure||||Participants|||Count of Participants
2631296|NCT01845831|Secondary|Hospital Mortality Rate|Mortality is defined as death occurring during admission.|Duration of Hospitalization (Up to 10 Days)||||participants|||Number
2631298|NCT01845831|Secondary|Length of Hospital Stay|Length of hospital stay in days.|Duration of Hospitalization (Up to 10 Days)||||days||Inter-Quartile Range|Median
2631301|NCT01845831|Primary|Change in HbA1C|The mean HbA1C measured at 3 months and 6 months post hospitalization. HbA1C is an indicator of diabetes control; below 6.0% is normal, 6.0% to 6.4% indicates prediabetes, and 6.5% or over indicates diabetes.|Post Hospital Discharge Month 3, Month 6|253 subjects who participated in the inpatient phase and were invited to complete the outpatient phase.|||percent||Standard Deviation|Mean
2631302|NCT01845831|Primary|Mean Percentage of Blood Glucose Readings Greater Than 13.3 mmol/L|Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.|Duration of Hospitalization (Up to 10 Days)||||percentage of blood glucose readings||Standard Deviation|Mean
2631303|NCT01845831|Primary|Mean Percentage of Blood Glucose Readings Between 5.6 - 7.8 mmol/L|Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.|Duration of Hospitalization (Up to 10 Days)||||percentage of blood glucose readings||Standard Deviation|Mean
2631304|NCT01845831|Primary|Mean Percentage of Blood Glucose Readings Between 3.9 - 10.0 mmol/L|Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.|Duration of Hospitalization (Up to 10 Days)||||percentage of blood glucose readings||Standard Deviation|Mean
2631305|NCT01845831|Primary|Mean Percentage of Blood Glucose Readings Between 3.9 - 7.8 mmol/L|Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D.|Duration of Hospitalization (Up to 10 Days)||||percentage of blood glucose readings||Standard Deviation|Mean
2631306|NCT01845831|Primary|Mean Blood Glucose Concentration After First Day of Treatment|The average blood glucose (BG) concentration after the first day of treatment|Duration of Hospitalization (Up to 10 Days)||||mmol/L||Standard Deviation|Mean
2631307|NCT01845818|Secondary|Participant's Global Assessment of Pain VAS Scores Over Time|The VAS score assessed by participants was used to determine the pain due to ankylosing spondylitis and psoriatic arthritis in the past week. The level of pain was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (no pain) to 100 (severe pain).|Baseline, Months 3, 6, 12, 18|Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment completed at given time point are included.|||mm||Standard Deviation|Mean
2631308|NCT01845818|Secondary|Participant's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time|The VAS score assessed by participants was used to determine the disease activity of ankylosing spondylitis and psoriatic arthritis in the past week. The level of disease activity was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (none) to 100 (most disease activity).|Baseline, Months 3, 6, 12, 18|Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment completed at given time point are included.|||mm||Standard Deviation|Mean
2631309|NCT01845818|Secondary|Physician's Assessment of Disease Activity Visual Analogue Scale (VAS) Scores Over Time|The VAS score assessed by physicians was used to determine the disease activity of ankylosing spondylitis and psoriatic arthritis in the past week. The level of disease activity was measured in millimeters (mm) on a 100 mm horizontal line. The score ranged from 0 (none) to 100 (most disease activity).|Baseline, Months 3, 6, 12, 18|Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment completed at given time point are included.|||mm||Standard Deviation|Mean
2631310|NCT01845818|Secondary|Acute Phase Reactant: C-Reactive Protein (CRP) Values Over Time|CRP is an acute phase reactant plasma protein, normally produced by the liver, which is commonly used as an indirect measure of the extent and activity of an inflammation. The CRP normal reference range in the blood is, as a rule, from 0 to 1.0 mg/dL. Last observation is the last observation after baseline at which an assessment was completed.|Baseline, Months 3, 6, 12, 18|Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment at given time point are included.|||mg/dL||Standard Deviation|Mean
2631311|NCT01845818|Secondary|Acute Phase Reactant: Erythrocyte Sedimentation Rate (ESR) Values Over Time|The ESR is a practicable and sensitive but not specific parameter for measuring disease progression. By means of the ESR it can be generally distinguished between an active and nonactive rheumatic disease. The normal reference range is, as a rule, 0 to 10 mm/h for men and 0 to 15 mm/h for women. The higher the ESR value out of the normal range, the higher is the disease activity. Last observation is the last observation after baseline at which an assessment was completed.|Baseline, Months 3, 6, 12, 18|Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with an assessment at given time point are included.|||mm/h||Standard Deviation|Mean
2631312|NCT01845818|Secondary|Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Scores Over Time (Ankylosing Spondylitis)|The BASDAI is used for measuring and evaluating disease activity in ankylosing spondylitis. This index consists of 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain/swelling, areas of localized tenderness (or enthesitis, defined as inflammation of tendons and ligaments), duration of morning stiffness, severity of morning stiffness. A visual analogue scale ranging from 0 (none) to 10 (very severe) is used to answer the questions. The final BASDAI score averages the individual assessments for a final score range of 0 to 10 (0 being no problem and 10 being the worst problem). Last observation is the last observation after baseline at which any of the questionnaire items was completed.|Baseline, Months 3, 6, 12, 18|Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.|||units on a scale||Standard Deviation|Mean
2631313|NCT01845818|Secondary|Percentage of Body Surface Area (BSA) Affected Over Time (Psoriatic Arthritis)|Percentage of BSA affected by psoriatic arthritis was assessed by clinical evaluation. Last observation is the last observation after baseline at which any of the questionnaire items was completed.|Baseline, Months 3, 6, 12, 18|Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a BSA assessment at given time point are included.|||percentage of participants|||Number
2631314|NCT01845818|Secondary|Disease Activity Score 28 (DAS-28) Over Time (Psoriatic Arthritis)|The DAS-28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS-28 score. Scores on the DAS-28 range from 0 to 10. A DAS-28 score > 5.1 indicates high disease activity, a DAS-28 score < 3.2 indicates low disease activity, and a DAS-28 score < 2.6 indicates clinical remission. Last observation is the last observation after baseline at which any of the questionnaire items was completed.|Baseline, Months 3, 6, 12, 18|Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.|||units on a scale||Standard Deviation|Mean
2631315|NCT01845818|Secondary|Health Assessment Questionnaire Modified for Spondyloarthropathies (HAQ-S) Scores Over Time (Ankylosing Spondylitis)|The HAQ-S is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (very severe, high-dependency disability). Last observation is the last observation after baseline at which any of the questionnaire items was completed.|Baseline, Months 3, 6, 12, 18|Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.|||units on a scale||Standard Deviation|Mean
2631316|NCT01845818|Secondary|Dermatology Life Quality Index (DLQI) Scores Over Time (Psoriatic Arthritis)|The DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0); responses are summed. The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. Last observation is the last observation after baseline at which any of the questionnaire items was completed.|Baseline, Months 3, 6, 12, 18|Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.|||units on a scale||Standard Deviation|Mean
2631317|NCT01845818|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores Over Time (Psoriatic Arthritis)|The HAQ-DI is a self-reported assessment of how the participant's disease affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores: dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. Scores range from 0 to 3, with a lower score demonstrating less disability. Last observation is the last observation after baseline at which any of the questionnaire items was completed.|Baseline, Months 3, 6, 12, 18|Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.|||units on a scale||Standard Deviation|Mean
2631318|NCT01845818|Secondary|Percentage of Impairment While Working Due to Disease (Presenteeism) 7 Days Prior to Each Visit|As measured by the WPAI-Specific Health Problem questionnaire. Presenteeism (the extent to which disease decreased productivity, as reported on the WPAI) is presented as the mean percentage of impairment while working due to disease, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Last observation is the last observation after baseline at which any of the questionnaire items was completed.|Baseline, Months 3, 6, 12, 18|Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a professional activity and with a questionnaire completed at given time point are included.|||percentage impairment while working||Standard Deviation|Mean
2631319|NCT01845818|Secondary|Percentage of Activity Impairment Due to Disease During the 7 Days Prior to Each Visit|Activity impairment due to disease (the extent to which disease affected the ability to perform usual daily activities, as reported on the WPAI) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Last observation is the last observation after baseline at which any of the questionnaire items was completed.|Baseline, Months 3, 6, 12, 18|Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a professional activity and with a questionnaire completed at given time point are included.|||percentage activity impairment||Standard Deviation|Mean
2631568|NCT01844284|Secondary|Number of Participants With Target Lesion Failure (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631320|NCT01845818|Secondary|Percentage of Missed Working Hours (Absenteeism) Due to Disease 7 Days Prior to Each Visit|Absenteeism, presented as the mean percentage of work time missed due to disease (as reported on the WPAI), and calculated as: 100*number of hours of work missed due to disease / (number of hours of work missed due to disease + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Last observation is the last observation after baseline at which any of the questionnaire items was completed.|Baseline, Months 3, 6, 12, 18|Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a professional activity and with a questionnaire completed at given time point are included.|||percentage of work time missed||Standard Deviation|Mean
2631321|NCT01845818|Secondary|Number of Participants Employed at Each Assessed Visit|As assessed by the WPAI questionnaire, a questionnaire used to evaluate lost work productivity due to disease (yes=employed; no=not employed). Last observation is the last observation after baseline at which any of the questionnaire items was completed.|Baseline, Months 3, 6, 12, 18|Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with a questionnaire completed at given time point are included.|||Participants|||Count of Participants
2631322|NCT01845818|Secondary|Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Separately)|"The mean percentage of TWPI due to disease (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which disease decreased productivity (%)* [number of hours worked / (number of hours of work missed due to disease + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change was calculated as the value at baseline minus the value at Month 18."|Baseline, Month 18|Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with professional activity and with a questionnaire completed at given time point are included.|||percentage of TWPI||Standard Deviation|Mean
2631323|NCT01845818|Primary|Change From Baseline at Month 18 in TWPI Due to Disease (Ankylosing Spondylitis and Psoriatic Arthritis Combined)|"The mean percentage of TWPI due to disease (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which disease decreased productivity (%)* [number of hours worked / (number of hours of work missed due to disease + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change was calculated as the value at baseline minus the value at Month 18."|Baseline, Month 18|Per Protocol Set: all participants enrolled in the study who received at least one dose of adalimumab, who had no major protocol deviations, and for whom any follow-up data were available. Participants with professional activity and with a questionnaire completed at given time point are included.|||percentage of TWPI||Standard Deviation|Mean
2631324|NCT01845792|Secondary|PSA Response|Prostate specific antigen (PSA) decline by 50% or more from baseline.|2 years||||Participants|||Count of Participants
2631325|NCT01845792|Primary|Progression-Free Survival|Progression-free survival at 3 months.|3 months|Due to early closure of the study and the low number of patients enrolled, no statistics or firm conclusions can be made.|||Participants|||Count of Participants
2631326|NCT01845636|Secondary|Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-plus)|The CIBIC-plus is a well-validated, reliable and widely used measure (range 1-7) of global improvement used in AD and MCI trials. This is a measure of change based on clinician impression.|Week 8, Week 26, Week 52||||units on a scale||Standard Deviation|Mean
2631327|NCT01845636|Secondary|Measurement of Everyday Cognition (Ecog)|"This instrument has 40 items, takes 20 minutes to administer, and focuses on functional correlates of cognitive deficits. This assessment asks the study informant to rate the participant's ability to perform certain tasks with the domains of Memory, Language, Visual-spatial and Perceptual Abilities, Executive Functioning: Planning, Executive Functioning: Organization, and Executive Functioning: Divided Attention. The informant is asked to compare functioning from 10 years prior to the time of testing. The Everyday Cognition measure uses the sum score of all of the subscales, and the items are reverse coded (i.e., 1= Better or no change, 2=Questionable/occasionally worse, 3=Consistently a little worse, 4=Consistently much worse), meaning that lower scores are better. Reported total scores range from 39 (Better or no change) to 156 (Consistently much worse)."|Week 0, Week 4, Week 8, Week 26, Week 52||||units on a scale||Standard Deviation|Mean
2631328|NCT01845636|Secondary|Pfeffer Functional Activities Questionnaire (FAQ)|"FAQ is a widely used 10-item instrument that takes 3 minutes to administer and focuses on instrumental, social and cognitive functioning. The assessment is completed by a study informant - typically a caregiver able to report best on the patient's current ability. The instrument assesses the patient's current ability, at the point of testing and through the past month, in these various domains. The total score is described as the cumulative scores of each item, ranging from 0 - No help needed to 3 - No, unable to do. More impairment is indicated by higher scores. The reported total score range is from 0 (no impairment score) to 30 (maximum impairment score)."|Week 0, Week 4, Week 8, Week 26, Week 52||||units on a scale||Standard Deviation|Mean
2631329|NCT01845636|Secondary|Total Number of Errors Measured Using the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)|The modified Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) is a cognitive battery that assesses learning, memory, language production, language comprehension, constructional praxis, ideational praxis, and orientation. The ADAS-Cog is not a timed test and the participant's score does not depend on how rapidly the test is completed. The ADAS-Cog total score is based on the total number of errors made in the test by the participant. Therefore, a lower total score indicates a higher cognitive performance. The total score ranges from 0 to 95 and is determined by summing the errors from 12 subscales. The total score, indicating number of errors made, is the number that is reported at each timeframe.|Week 0, Week 8, Week 26, Week 52||||Errors||Standard Deviation|Mean
2667329|NCT01516424|Secondary|Mean Change in PANSS Symptom Scores|Mean change in PANSS symptom scores from baseline at Week 8|Week 8|||||||
2631330|NCT01845636|Primary|Selective Reminding Test (SRT)|The Selective Reminding Test (SRT) is a 12-item test of verbal learning and memory. To administer, the researcher will read aloud a list of 12 words. The participant repeats each word aloud to ensure that the word was heard correctly. Immediately following the reading of all 12 words, the participant is asked to recall as many words as possible within the one minute time limit. The participant is then reminded of the words they did not say and asked to recall the list again. This process is repeated for 6 trials. The total immediate recall is the total number of words recalled by the participant from all 6 trials. This is the number that is reported. Lower scores indicate fewer words recalled and a poorer performance.|Week 0, Week 8, Week 26, Week 52||||Words||Standard Deviation|Mean
2631331|NCT01845220|Primary|Mean Area of Skin Erythema (Skin Redness)|For three days in a row, volunteers will receive skin treatments with broccoli sprout extract. On day four, their skin will be measured for a baseline skin color reading. Immediately following this reading, the treated areas of the skin will be challenged with 70 percent alcohol and the redness of the skin will again be measured every 30 minutes for the following two hours for skin color changes. The values were collected every 30 minutes after the alcohol skin challenge for 2 hours and were averaged. Mean and 95% Confidence Interval are reported.|mean up to 2 hours|Since experimental conditions were refined part way through the series and only the last 19 individuals' data was deemed suitable for analysis.|||centimeters^2||95% Confidence Interval|Mean
2631332|NCT01845155|Secondary|Change in Tinnitus Frequency (Pitch), Obtained at Admission (Pre) and After Therapy Intervention (Post)||the average time period was 3 months||||Hz||Standard Deviation|Median
2631333|NCT01845155|Primary|Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) Total Score Change From Baseline to End of Treatment|Tinnitus severity was assessed by the German version of the tinnitus questionnaire (TQ, Goebel and Hiller 1994). The TQ consists of a total of 52 items. The questionnaire records tinnitus related complaints on a global TQ-score. The range of values is between the minimum score of 0 and the maximum score of 84, whereas high values indicate high tinnitus related distress.|average time period was 3 months||||absolute TF-score change||Standard Deviation|Mean
2631334|NCT01845103|Secondary|Major Adverse Coronary and Cerebrovascular Events (MACCE)|"MACCE includes:~Cardiac related death, CVA, Myocardial Infarction, Serious arrhythmia, CHF"|30 day||||percentage of participants|||Number
2631335|NCT01845103|Primary|Mortality||30 day||||percentage of participants|||Number
2631336|NCT01845077|Primary|Cmax of Metformin|Maximum Measured Concentration (Cmax) of Metformin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2631337|NCT01845077|Primary|AUC0-tz of Metformin|Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2631338|NCT01845077|Secondary|AUC0-infinity of Metformin|Area under the concentration-time curve of Metformin in plasma over the time interval from 0 extrapolated to infinity based on predicted last concentration values. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2631339|NCT01845077|Secondary|AUC0-infinity of Linagliptin|Area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 extrapolated to infinity based on predicted last concentration values. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2631340|NCT01845077|Primary|Cmax of Linagliptin|Maximum Measured Concentration (Cmax) of Linagliptin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2667330|NCT01516424|Secondary|Mean Change in PANSS 5-factor Model|Mean change in PANSS 5-factor model from baseline at Week 8|Week 8|||||||
2631341|NCT01845077|Primary|AUC0-72 of Linagliptin|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.|1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period|Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2631342|NCT01845025|Secondary|Unplanned Healthcare Utilization at Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (Week 26)|Unplanned healthcare utilization by visit (Telephone contact with study doctor (MD); Telephone contact with other physician (MD) or healthcare provider (HCP); Unscheduled or unplanned visit to study doctor (including home visits); Unscheduled or unplanned visit to other physician or healthcare provider (including home visits); Emergency department or hospital visit (< 24 hours); Hospital admission or Emergency department visit (> 24 hours).|Week 4, Week 12, and Week 26|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication|||unplanned visits|||Number
2631343|NCT01845025|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ - 6) Total Score at Week 26|Change from baseline in Asthma control Questionnaire (ACQ - 6) total score at week 26. Results of the Asthma control questionnaire (ACQ-6); The average score of the six questions is calculated as the sum of scores divided by the number of questions that were answered at the time point, as long as there were at least 4 questions answered. The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a total score of 0 corresponds to no impairment and a total score of 6 corresponds to maximum impairment.|baseline and 26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication|||total score on a scale||Standard Deviation|Mean
2631344|NCT01845025|Secondary|Percentage of Days With no Symptoms at 26 Weeks|Percentage of days with no symptoms during the treatment period (26 weeks). Percentage is calculated as total number of days with no symptoms divided by total days of treatment.|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication|||percentage of days||Standard Deviation|Mean
2631345|NCT01845025|Secondary|Percentage of Days With no Rescue Medication Use at 26 Weeks|Percentage of rescue free days is calculated as total number of days with no rescue medication was taken divided by total days of treatment.|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication|||percentage of days||Standard Deviation|Mean
2631346|NCT01845025|Secondary|Percentage of Days With Nighttime Awakenings at 26 Weeks|Percentage of days with nighttime awakenings during the treatment period (26 weeks)|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication|||percentage of days||Standard Deviation|Mean
2631347|NCT01845025|Secondary|Percentage of Days With Limited Ability to Perform Normal Daily Activities at 26 Weeks|The percentage of days with limited ability to perform normal daily activities during the treatment period (26 weeks). Percentage is calculated as total number of days when the patient had limited ability to perform normal daily activities divided by total days of treatment.|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication|||percentage of days||Standard Deviation|Mean
2631348|NCT01845025|Secondary|Percentage of Days of School/Work Missed at 26 Weeks|The percentage of days of school/work missed during the treatment period (26 weeks). Overall percentage of school days missed for each student patient or of work days missed is calculated by total number of days missed divided by total days of treatment.|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication|||percentage of days||Standard Deviation|Mean
2631349|NCT01845025|Secondary|Number of Asthma Exacerbations at 26 Weeks|Number of asthma exacerbations events|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication|||events||Standard Deviation|Mean
2631350|NCT01845025|Primary|Number of First Occurrence(s) of Any Composite Endpoint Including Asthma-related Hospitalizations, Intubations and Deaths During the Study at 26 Weeks|The primary safety endpoint was the number of first occurrence(s) of any composite endpoint. The composite events include asthma-related deaths, asthma-related intubations and asthma-related hospitalizations. The number of events includes all adjudication confirmed events, one patient could experience multiple events during the course of study; Event rate = 100 * n patients with any events / total N patients in treatment group.|26 weeks|Intent to treat (ITT) population included all randomized patients who took at least one dose (one inhalation) of study medication|||number of occurences|||Number
2631351|NCT01844986|Secondary|Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS|To assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and potential future BRCA mutation assays (gene sequencing and large rearrangement analysis)|Radiologic scans performed at baseline then every 12 weeks for the first 156 weeks, then every 24 weeks thereafter, assessed until disease progression. Analysis of data assessed up to a maximum of 54 months.|FAS consisting of all patients who are randomized and confirmed as Myriad gBRCAm|||Months||95% Confidence Interval|Median
2631352|NCT01844986|Secondary|Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Study Treatment Discontinuation or Death (TDT)|To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to study treatment discontinuation or death (TDT).|Time elapsed from randomization to study treatment discontinuation or death. Analysis of data assessed up to a maximum of 54 months. A further analysis of TDT may be performed at approximately 60% OS maturity.|Full Analysis Set (FAS) consisting of all patients who are randomized|||Months||95% Confidence Interval|Median
2631353|NCT01844986|Secondary|Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Second Subsequent Therapy or Death (TSST)|To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to second subsequent therapy or death (TSST)|Assessed every 12 weeks following treatment discontinuation. Analysis of data assessed up to a maximum of 54 months. A further analysis of TSST will be performed at approximately 60% OS maturity.|Full Analysis Set (FAS) consisting of all patients who are randomized|||Months||95% Confidence Interval|Median
2631354|NCT01844986|Secondary|Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to First Subsequent Therapy or Death (TFST)|To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to first subsequent therapy or death (TFST)|Assessed every 12 weeks following treatment discontinuation. Analysis of data assessed up to a maximum of 54 months. A further analysis of TFST will be performed at approximately 60% OS maturity.|Full Analysis Set (FAS) consisting of all patients who are randomized|||Months||95% Confidence Interval|Median
2631355|NCT01844986|Secondary|Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)|To compare the effects of olaparib maintenance monotherapy compared to placebo on Health-related Quality of Life (HRQoL) as assessed by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.|Questionnaires will be given to the patient at baseline, at Day 29 and then every 12 weeks for 156 weeks, then every 24 weeks or until the data cut off for the PFS analysis, change in TOI over 24 months reported|FAS consisting of all patients who are randomized with a baseline and post baseline TOI scores available|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2631356|NCT01844986|Secondary|Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time From Randomization to Second Progression|To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time from randomisation to second progression (PFS2)|Following first progression disease then assessed per local practice every 12 weeks until second progression. Analysis of data assessed up to a maximum of 54 months.|Full Analysis Set (FAS) consisting of all patients who are randomized|||Months||95% Confidence Interval|Median
2631357|NCT01844986|Secondary|Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Time to Earliest Progression by RECIST or Cancer Antigen (CA-125) or Death|To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of time to earliest progression by RECIST or Cancer Antigen-125 (CA-125)|CA-125 performed at baseline then every 4 weeks. Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks until objective radiological disease progression. Analysis of data assessed up to a maximum of 54 months.|Full Analysis Set (FAS) consisting of all patients who are randomized|||Months||95% Confidence Interval|Median
2631358|NCT01844986|Secondary|Efficacy in Patients Following First Line Platinum Based Chemotherapy by Assessment of Overall Survival|To determine the efficacy of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy by assessment of overall survival (OS)|Survival assessed every 4 weeks until treatment discontinues, then every 12 weeks (analysis of data assessed up to a maximum of 54 months). Analysed at the PFS analysis and a further analysis of OS will be performed at approximately 60% maturity.|Full Analysis Set (FAS) consisting of all patients who are randomized|||Months||95% Confidence Interval|Median
2631359|NCT01844986|Primary|Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1)|To determine the efficacy by progression free survival (PFS) using investigator assessment according to modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy.|Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. Analysis of data assessed up to a maximum of 54 months.|Full Analysis Set (FAS) consisting of all patients who are randomized|||Months||95% Confidence Interval|Median
2631360|NCT01844895|Secondary|Number of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) on Day 29 and Day 113.|Serum samples for immunogenicity were evaluated for presence of anti-abatacept antibodies using a validated bridging ECL on Day 29 and Day 113. The ECL assay differentiated between 2 antibody specificities: the immunoglobulin (Ig) G and/or junction region and cytotoxic leukocyte antigen 4 (CTLA4) and possibly Ig. A positive immunogenicity response relative to baseline was defined as: A missing baseline immunogenicity measurement and a positive analytical laboratory reported immunogenicity response post-baseline; A negative baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline; A positive baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline that has a titer value strictly greater than the baseline titer value.|Days 29 and 113|A subset of the treated analysis population for whom at least 1 immunogenicity sample was collected and assessed for serum anti-abatacept antibodies, were summarized.|||participants|||Number
2631569|NCT01844284|Secondary|Number of Participants With Target Lesion Failure (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|6 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631361|NCT01844895|Secondary|Geometric Mean of Trough Serum Concentration (Cmin) Over Time and During the Switch From Prefilled Syringe to Autoinjector on Days 22, 29, 57, 85, 106, and 113|Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken at 0 hour (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy. Blood samples for PK were taken at 0 hour (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. Steady-state trough observed concentration in serum (Cminss) was measured in micrograms/milliliter (μg/mL).|Days 22, 29, 57, 85, 106, and 113|PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector and with Cmin obtained appropriately (7 days + or -3 days after the previous dose).|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2631362|NCT01844895|Secondary|Geometric Mean of Area Under Serum Concentration-time (AUC) During a Dosing Interval (TAU) of Abatacept During the Sampling Period Between Days 22 and 29 for the Prefilled Syringe and Between Days 106 and Day 113 for the Autoinjector|Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken on Days 1 and 22 at 0 hour (predose), Day 24 at 48 hour (h) post dose, Day 25 at 72 h post dose, Day 26 at 96 h post dose and Day 29 at 0 h (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy; Blood samples for PK were taken on Day 106 at 0 h (predose), Day 108 at 48 h post dose, Day 109 at 72 h post dose, Day 110 at 96 h post dose and at Day 113 0h (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. AUC(TAU) where TAU = 168 hours was calculated in µg*h/mL|Days 22, 24, 25, 26,29 (prefilled syringe); Days 106, 108, 109, 110, 113 (autoinjector)|PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector. Participants did not miss either 0-hour or 168-hour samples and not missed 2 or more time points in the PK profile.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2631363|NCT01844895|Secondary|PK Analysis: Median Time to Achieve Cmax (Tmax) During the Sampling Period Between Days 22 and 29 for the Prefilled Syringe and Between Days 106 and Day 113 for the Autoinjector|Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken on Days 1 and 22 at 0 hour (predose), Day 24 at 48 hour (h) post dose, Day 25 at 72 h post dose, Day 26 at 96 h post dose and Day 29 at 0 h (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy; Blood samples for PK were taken on Day 108 at 48 h post dose, Day 109 at 72 h post dose, Day 110 at 96 h post dose and at Day 113 0h (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. Tmax was measured in hours (h).|Days 22, 24, 25, 26, 29 (prefilled syringe); Days 106, 108, 109, 110,113 (autoinjector)|PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector. Participants did not miss either 0-hour or 168-hour samples and not missed 2 or more time points in the PK profile.|||h||Full Range|Median
2631364|NCT01844895|Secondary|PK Analysis: Geometric Mean of Maximum Observed Serum Concentration (Cmax) of Abatacept During the Sampling Period Between Substudy Days 22 and 29 for the Prefilled Syringe and Between Substudy Days 106 and Day 113 for the Autoinjector|Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken on Days 1 and 22 at 0 hour (predose), Day 24 at 48 hour (h) post dose, Day 25 at 72 h post dose, Day 26 at 96 h post dose and Day 29 at 0 h (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy; Blood samples for PK were taken on Day 108 at 48 h post dose, Day 109 at 72 h post dose, Day 110 at 96 h post dose and at Day 113 0h (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. Cmax was measured in μg/mL.|Days 22, 24, 25, 26, 29 (prefilled syringe); Days 106, 108, 109, 110, 113 (autoinjector)|PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector. Participants did not miss either 0-hour or 168-hour samples and not missed 2 or more time points in the PK profile.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2631365|NCT01844895|Primary|Pharmacokinetic (PK) Analysis: Adjusted Geometric Mean Observed Serum Trough Concentration at Steady State (Cminss) of Abatacept Using a Prefilled Syringe (Measured on Day 29) and Using an Autoinjector (Measured on Day 113)|Abatacept SC was self-administered with a prefilled syringe every 7 days for the first 4 weeks until Day 29; Blood samples for PK were taken pre-dose (0 hour) on Days 29 and 113. Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Steady-state trough observed concentration in serum (Cminss) was measured in micrograms/milliliter (μg/mL). Adjusted geometric mean and 90% confidence interval (CI) are presented.|Day 29, Day 113|The primary PK analysis population is a subset of the Treated Analysis population with (1) viable Cmin data on both substudy Days 29 and 113 (2) no missed Abatacept dose during the substudy period.|||μg/mL||90% Confidence Interval|Geometric Mean
2631366|NCT01844856|Secondary|Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Clinically Evaluable (CE) Population at the TOC Visit|Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the EOT visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.|TOC visit: 25-31 days after first dose|All randomized participants who had no major protocol deviations (CE population).|||participants|||Number
2631367|NCT01844856|Secondary|Clinical Response of Eravacycline and Ertapenem Treatment Arms in the Modified Intent-to-treat (MITT) Population at the TOC Visit|Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the EOT visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.|TOC visit: 25-31 days after first dose|All randomized participants who received at least 1 dose of study drug (MITT population).|||participants|||Number
2631368|NCT01844856|Primary|Clinical Response of Eravacycline and Ertapenem Treatment Arms at the Test-of-cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population|Clinical response was classified as cure (complete resolution or significant improvement of signs and symptoms of the index infection), failure (death related to complicated intra-abdominal infection [cIAI], unplanned surgical procedures or percutaneous drainage procedures, persisting or recurrent infection within the abdomen, postsurgical wound infection, or administration of effective concomitant antibacterial therapy), or indeterminate (outcome was neither cure nor failure, or assessment was not available). Participants who were failures at the End-of-Treatment (EOT) visit (within 24 hours of last dose) were considered failures at the TOC visit. The number of participants with a clinical response classification of cure, failure, or indeterminate is presented.|TOC visit: 25-31 days after the first dose of study drug|All randomized participants who had baseline bacterial pathogens that cause cIAI and against at least one of which the investigational drug has in vitro antibacterial activity (micro-ITT population).|||participants|||Number
2631369|NCT01844830|Secondary|Results of Naris Examination (NE) - Bleeding||120 minutes post drug administration||||Participants|||Count of Participants
2631370|NCT01844830|Secondary|Results of Naris Examination (NE) - Inflammation||120 minutes post drug administration||||Participants|||Count of Participants
2631371|NCT01844830|Secondary|Results of Naris Examination (NE) - Color|The investigators performed a visual inspection and evaluated the treatment naris for color of the mucosa. The investigator determined what color (Pink, Slightly Red, Red) best matched and recorded the results.|120 minutes post drug administration||||Participants|||Count of Participants
2631372|NCT01844830|Secondary|Maximum Change From Baseline in Diastolic Blood Pressure||from baseline to 24 hours following drug administration||||mmHg||Standard Deviation|Mean
2631373|NCT01844830|Secondary|Maximum Change From Baseline in Systolic Blood Pressure||from baseline to 24 hours following drug administration||||mmHg||Standard Deviation|Mean
2631374|NCT01844830|Secondary|Maximum Change From Baseline in Heart Rate||from baseline to 24 hours following drug administration||||bpm||Standard Deviation|Mean
2631375|NCT01844830|Secondary|Results of Naris Examination (NE) - Patency and Ulcerations|"The investigators evaluated the treatment naris for patency and ulcerations.~Patency was evaluated as followed: The nostril not used for dosing study drug was manually occluded and the subject was asked to sniff gently. Airflow in the naris was used to determine if it was patent (yes) or not (no).~For ulcers, the investigators performed a visual examination for the presence of ulcers and recorded if they were present (yes) or not (no)."|120 minutes post drug administration||||Participants|||Count of Participants
2631376|NCT01844830|Secondary|Incidence of Adverse Events (AEs) by Age Group|Patients with AEs|from baseline to 24 hours following drug administration|Patients group by age|||Count of participants|||Number
2631377|NCT01844830|Secondary|Incidence of Adverse Events (AEs) by Dosage Cohort|Patients with AEs|from baseline to 24 hours following drug administration|Patients grouped by dosage cohort|||Count of participants|||Number
2631378|NCT01844830|Secondary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. by Age Group (3-5, 6-11, and 12-17 Years Old, Inclusive).|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.|100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window|Patients are grouped by age|||Participants|||Count of Participants
2631379|NCT01844830|Secondary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.by Dosage Cohort.|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.|100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window|Subjects were in only 1 of 3 dosage cohort. Either 100 µL, 200 µL, or 400 µL.|||Participants|||Count of Participants
2631380|NCT01844830|Primary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.|100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window||||Participants|||Count of Participants
2631381|NCT01844817|Secondary|Objective Response Rate|Objective response rate defined as the percent of patients having a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR=complete disappearance of all target lesions. PR=decrease in baseline of 30% or more of the diameter(s) of all target lesions.|Every 8 weeks for up to 2 years|Includes Intent-to-Treat Population: all subjects enrolled and randomized|||percentage of participants|||Number
2631399|NCT01844765|Secondary|Time to Disease Progression for Imatinib or Dasatinib Resistant or Intolerant CML-CP Patients|Time to disease progression is the time from the date of first study drug intake to the date of event defined as the first progression to AP or BC (from CP) or to BC (from AP) or the date of CML-related death occurring on treatment, whichever was earlier.|up to disease progression (assessed up to a minimum of 12 cycles after first dose of treatment (June 2016))|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Participants with disease progression|||Number
2631382|NCT01844817|Secondary|Progression-Free Survival|The time (in months) that patients are progression-free, assessed from date of randomization to date of first documented disease progression or date of death from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum while on study (this includes the baseline sum if that is the smallest on study), or the appearance of one or more new lesions.|Every 8 weeks up to 2 years|Intent-to-Treat Population: all subjects enrolled and randomized|||months||95% Confidence Interval|Median
2631383|NCT01844817|Primary|Overall Survival|Overall survival defined as the time, in months, from date of randomization until date of death or date last known alive whichever comes first, assessed up to 2 years.|Up to 2 years|Includes Intent-to-Treat Population: all subjects enrolled and randomized|||months||95% Confidence Interval|Median
2631384|NCT01844778|Secondary|Number of Participants With Post-inhalation Bronchospasm|Bronchospasm was defined as the relative decrease of 20% or more in forced expiratory volume in 1 second (FEV1) percent predicted from pre-dose to 15 to 45 minutes post-dose.|days 1, 28, 57, 84|The FAS was considered for the analysis and included participants who had at least one dose of study treatment. Only participants (n), with values on a given day, were analyzed for that day.|||Participants|||Number
2631385|NCT01844778|Secondary|Minimum Inhibitory Concentration (MIC) - MIC50 and MIC90 Tobramycin Values|MIC50/90 is the lowest concentration required to inhibit 50%/90% of the isolates tested. The MIC50/90 of a range of antibiotics for P.aeruginosa was determined at the start and end of each treatment cycle, and at the end of the off-treatment period of the second cycle.|days 1, 28, 57, 84, 112|The FAS was considered for the analysis and included participants who had at least one dose of study treatment. Only participants (n), with values on a given day, were analyzed for that day. The number of isolates tested = m.|||ug/mL|||Number
2631386|NCT01844778|Secondary|Number of Participants With Any Contaminated Delivery Device|Devices used to administer the drugs (the T-326 inhaler and nebulisers) were swabbed for contamination testing at the start and end of each treatment cycle (or discontinuation visit if the participant withdrew). No assessments were required from the T-326 inhaler when participants started the treatment period (days 1 and 57). Microbial contamination was measured according to device type and the frequency of organism growth (light/ moderate/ heavy). All nebulisers (neb) used by the participants were analyzed, including those for inhaling other medications, like mucolytics.|days (d) 1, 28, 57, 84|The FAS was considered for the analysis and included participants who had at least one dose of study treatment. Only participants (n), with an available culture from the delivery device, were analyzed.|||Participants|||Number
2631387|NCT01844778|Secondary|Change in P. Aeruginosa Sputum Density|Sputum samples were sent to a central laboratory at the start and end of 2 treatment periods. The absolute change in the number of colony forming units (CFU) of Pseudomonas aeruginosa in sputum = the value of end of on/off treatment period of the cycle minus the pre-dose value at the start of that cycle. A negative change from baseline indicates improvement.|days 1, 28 (cycle 1); 57, 84, 112 (cycle 2)|"The FAS was considered and included participants who received at least 1 dose of treatment. Only participants (n), with values at the start and end of an on-treatment period (on-treatment change), and/or with values at the start of an on-treatment period and end of an off-treatment period (off-treatment change), were analyzed."|||log10 CFU/mL||Standard Deviation|Mean
2631388|NCT01844778|Primary|Mean Total Administration Time|The mean total time for administration of TIP via T-326 inhaler versus the total time for administration of COLI or TIS was assessed from information entered by participants into an ediary during the last 7 days prior to the last dose of a cycle. The total time included the setup, preparation, administration and cleaning/disinfection time.|days 22 through 28 (cycle 1), days 78 through 84 (cycle 2)|The full analysis set (FAS) was considered for this analysis. The FAS included participants who received at least 1 dose of treatment. Only participants (n), with non-missing mean total administration time of initial and second cycles, were analyzed.|||minutes||Standard Deviation|Mean
2631389|NCT01844765|Secondary|Rate of Major Cytogenetic Response (MCyR) and Confirmed Cytogenetic Response (CCyR) in Newly Diagnosed Ph+ CML and in Ph+ CML-AP Patients Resistant/Intolerant to Either Imatinib or Dasatinib|Rate of major cytogenetic response (MCyR) and confirmed cytogenetic response (CCyR) in Newly diagnosed Ph+ CML and in Ph+ CML-AP patients resistant/intolerant to either imatinib or dasatinib by designated timepoints|6, 12, 18, 24, 36, 48, 66 cycles||2021-10-31|10/2021||||
2631390|NCT01844765|Other Pre-specified|Long Term Effect on Nilotinib on Bone Metabolism|Alteration of bone biochemical markers, DEXA and X-Ray|up to 66 cycles||2021-10-31|10/2021||||
2631391|NCT01844765|Secondary|Acceptability of Study Drug Formulation|Questionnaire to capture patient assessment of palatability (very good to very bad) and acceptability of taking the medication (very easy to very hard to administration).|day1, day 28, early discontinuation or month 12||2021-10-31|10/2021||||
2631392|NCT01844765|Secondary|Long Term Effect of Nilotinib on Growth, Development and Maturation|Assessment of development (growth and sexual maturation) and thyroid function|up to 66 cycles||2021-10-31|10/2021||||
2631393|NCT01844765|Secondary|Emerging Signs of Resistance|Mutational assessment of BCR-ABL|up to 66 cycles||2021-10-31|10/2021||||
2631394|NCT01844765|Secondary|PK Profile of Nilotinib in Pediatric Patients|Population PK parameters of nilotinib|up to 12 cycles||2021-10-31|10/2021||||
2631395|NCT01844765|Secondary|Rate of Cytogenetic Response Category|Rate of cytogenetic response (complete, partial, major, minor, minimal and no response) in Ph+ CML-CP resistant/intolerant to imatinib or dasatinib by 6, 12, 18,24, 36, 48 and 66 cycles|6, 12, 18, 24, 36, 48, 66 cycles||2021-10-31|10/2021||||
2631396|NCT01844765|Secondary|Event Free Survival|Event Free Survival is defined as the time from the date of first study drug intake to the first occurrence of any of the following loss of CHR, loss of MCyR ( PCyR + CCyR), progression to AP/BC (from CP) or to BC (from AP), or death from any cause. (Including events only during treatment)|up to 66 cycles||2021-10-31|10/2021||||
2631397|NCT01844765|Secondary|Pharmacodynamics|BCR-ABL transcript levels determined with standard protocols in peripheral blood and bone marrow for all time points with available data|up to 66 cycles||2021-10-31|10/2021||||
2631398|NCT01844765|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the date of first study drug intake to the date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of their last assessment for patients on study and date of last contact for patients in follow-up.|up to 66 cycles||2021-10-31|10/2021||||
2631400|NCT01844765|Secondary|Time to Disease Progression for Newly Diagnosed Ph+ CML-CP|Time to disease progression is the time from the date of first study drug intake to the date of event defined as the first progression to AP or BC (from CP) or to BC (from AP) or the date of CML-related death occurring on treatment, whichever was earlier.|up to disease progression (assessed up to a minimum of 12 cycles after first dose of treatment (June 2016))|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Participants with disease progression|||Number
2631401|NCT01844765|Secondary|Cumulative Best BCR-ABL Ratio Categories for Newly Diagnosed Ph+ CML-CP by 6 and 12 Cycles|MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. BCR-ABL ratio by percentage: > 0.0032 to ≤ 0.01% is equal to a log reduction category of >= 4 to <4.5 -log reduction (MR4); BCR-ABL ratio by percentage: <=0.0032% is equal to a log reduction category of >= 4.5-log reduction (MMR4.5)|minimum of 12 cycles|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Percentage of participants|||Number
2631402|NCT01844765|Secondary|Cumulative Best BCR-ABL Ratio Categories for Resistant/Intolerant Ph+ CML in CP by 6 and 12 Cycles|MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. BCR-ABL ratio by percentage: > 0.0032 to ≤ 0.01% is equal to a log reduction category of >= 4 to <4.5 -log reduction (MR4); BCR-ABL ratio by percentage: <=0.0032% is equal to a log reduction category of >= 4.5-log reduction (MMR4.5)|minimum of 12 cycles|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Percentage of participants|||Number
2631403|NCT01844765|Secondary|Duration of First MMR Among Patients Who Were Resistant or Intolerant to Either Imatinib or Dasatinib Who Achieved MMR|Duration of MMR is defined as the time between the date of the first MMR and the date of confirmed loss of MMR (i.e. the earliest of confirmed loss of MMR, CML-related death or progression to AP or BC). Participants without loss of MMR were censored at the last molecular assessment date.|from MMR until confirmed loss of MMR (Assessed up to June 2016, minimum of 12 cycles)|Full Analysis Set (FAS): All patients who received at least one dose of study medication. 19 of the 33 Resistant/intolerant Ph+ CML-CP participants achieved MMR up to June 2016.|||Participants with confirmed loss of MMR|||Number
2631404|NCT01844765|Secondary|Time to First MMR Among Imatinib or Dasatinib Resistant or Intolerant CML-CP Patients Who Achieved MMR|Time from first study drug intake to first MMR amongst imatinib or dasatinib resistant or intolerant patients with CML-CP computed only for patients who achieved MMR.|From first dose of study treatment until MMR criteria are met (Assessed up to June 2016, minimum of 12 cycles)|Full Analysis Set (FAS): All patients who received at least one dose of study medication. 19 of the 33 resistant/intolerant Ph+ CML-CP participants achieved MMR up to June 2016.|||months||95% Confidence Interval|Median
2631405|NCT01844765|Secondary|MMR Rate by Time Points in Ph+ CML-CP Patients Resistant or Intolerant to Imatinib or Dasatinib|MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. A patient was counted as having MMR by a time point if the patient met the MMR criteria at least once at any time between first study drug intake and the time point visit included.|By 3, 6, 9 & 12 cycles|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Percentage of participants||95% Confidence Interval|Number
2631406|NCT01844765|Secondary|Duration of First MMR Among Newly Diagnosed Patients Who Achieved MMR|Duration of MMR is defined as the time between the date of the first MMR and the date of confirmed loss of MMR (i.e. the earliest of confirmed loss of MMR, CML-related death or progression to AP or BC). Participants without loss of MMR were censored at the last molecular assessment date.|from MMR until confirmed loss of MMR (Assessed up to June 2016, minimum of 12 cycles)|Full Analysis Set (FAS): All patients who received at least one dose of study medication. 17 of the 25 newly diagnosed Ph+ CML-CP participants achieved MMR up to June 2016.|||Participants with confirmed loss of MMR|||Number
2631407|NCT01844765|Secondary|Time to First MMR Among Newly Diagnosed Ph+ CML-CP Patients Who Achieved MMR|Time to MMR is the time from first study drug intake to first major molecular response computed only for participants who achieved MMR.|From first dose of study treatment until MMR criteria are met (Assessed up to June 2016, minimum of 12 cycles)|Full Analysis Set (FAS): All patients who received at least one dose of study medication. 17 of the 25 newly diagnosed Ph+ CML-CP participants achieved MMR up to June 2016.|||Months||95% Confidence Interval|Median
2631408|NCT01844765|Secondary|MMR Rate by Time Points in Newly Diagnosed Ph+ CML-CP Patients|MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. A patient was counted as having MMR by a time point if the patient met the MMR criteria at least once at any time between first study drug intake and the time point visit included.|by 3, 6, 9 and 12 cycles|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Percentage of participants||95% Confidence Interval|Number
2631409|NCT01844765|Secondary|CCyR Rate by Cycles 6 and 12 in Newly Diagnosed Ph+ CML-CP Patients|Cytogenetic response is assessed as the percentage of Philadelphia positive (Ph+) metaphases in the bone marrow. Complete Cytogenetic Response (CCyR) is defined as 0% of Ph+ metaphases. A patient was counted as having CCyR by 6 cycles (respectively 12 cycles) if the patient met the CCyR criteria at least once at any time between first study drug intake and cycle 6 (cycle 12 respectively) visit included.|6 & 12 cycles|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Percentage of participants||95% Confidence Interval|Number
2631410|NCT01844765|Primary|Rate of Complete Cytogenic Response (CCyR) at 12 Cycles in Newly Diagnosed Ph+ CML-CP Patients|Cytogenetic response is assessed as the percentage of Philadelphia positive (Ph+) metaphases in the bone marrow. Complete Cytogenetic Response (CCyR) is defined as 0% of Ph+ metaphases. A patient was counted as CCyR at 12 cycles if the patient met the CCyR criteria at the Cycle 12 Visit.|12 cycles|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Percentage of participants||95% Confidence Interval|Number
2631411|NCT01844765|Primary|MMR Rate by 12 Cycles in Newly Diagnosed Ph+ CML-CP Patients|MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. A patient was counted as having MMR by 12 cycles if the patient met the MMR criteria at least once at any time between first study drug intake and Cycle 12 visit included.|12 cycles|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Percentage of participants||95% Confidence Interval|Number
2631412|NCT01844765|Primary|Rate of Major Molecular Response (MMR) at 6 Cycles for Ph+ CML CP Patients Resistant or Intolerant to Imatinib or Dasatinib|MMR is defined as ≤ 0.1% BCR-ABL/control gene (ABL) % by international scale, or equivalent to ≥ 3 log reduction of BCR-ABL transcript from standardized baseline, measured by RQ-PCR (Real time quantitative polymerase chain reaction). BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes. A patient was counted as having MMR at 6 cycles if the patient met the MMR criteria at the Cycle 6 Visit.|6 cycles|Full Analysis Set (FAS): All patients who received at least one dose of study medication|||Percentage of participants||95% Confidence Interval|Number
2631413|NCT01844700|Secondary|BMI Percentile||baseline to week 12||||BMI percentile||Standard Deviation|Mean
2631414|NCT01844700|Secondary|BMI Z-scores||baseline to week 12||||BMI z-score||Standard Deviation|Mean
2631415|NCT01844700|Secondary|Percent Weight Change Compared to Baseline Weight||baseline to week 12||||percentage of weight change||Standard Deviation|Mean
2631416|NCT01844700|Primary|Weight Change||baseline to week 12||||lbs||Standard Deviation|Mean
2631417|NCT01844687|Other Pre-specified|Plasma Concentration of CBD|Plasma concentrations of cannabidiol were measured at six time points after oral administration of four 200 mg capsules of CBD.|6 hours|8 participants volunteered to come to a ninth session for dosing with 800 mg CBD and donation of 7 blood samples.|||ng/mL||Standard Error|Mean
2631418|NCT01844687|Other Pre-specified|Heart Rate|Heart rate measured at 10 time points, 4 before and 6 after smoking cannabis.|120 minutes before and 150 minutes after marijuana cigarette smoking|all study completers|||beats per minute||Standard Error|Mean
2631419|NCT01844687|Other Pre-specified|Number of Optional Puffs of MJ Cigarette Taken|Mean number of puffs taken by those participants who chose to take additional puffs.|150 to 160 minutes after first marijuana cigarette was smoked earlier in the day|Those who took additional puffs of MJ cigarette.|||number of puffs taken per participant||Standard Error|Mean
2631420|NCT01844687|Other Pre-specified|Optional Additional Puffs of MJ Cigarette|Participants were allowed to choose to take or reject additional puffs of the same type of MJ cigarette they smoked earlier in the day. Counts of participants choosing to take additional puffs are reported.|150 to 250 minutes after first marijuana cigarette was smoked earlier in the day|all study completers|||Participants|||Count of Participants
2631421|NCT01844687|Other Pre-specified|Marijuana Rating Form - Strength|Participants rated the strength effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most|15 - 120 minutes after marijuana cigarette smoking|all study completers|||units on a scale||Standard Error|Mean
2631422|NCT01844687|Other Pre-specified|Marijuana Rating Form - Like|Participants rated how much they liked the effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most|15 - 120 minutes after marijuana cigarette smoking|all study completers|||units on a scale||Standard Error|Mean
2631423|NCT01844687|Primary|Mood Scale - Subscale 'Feeling High'|"Participants rated how much they felt having a high feeling from smoked marijuana using a visual analog scale 1-100 mm, 1 (Not at all) - 100 (extremely)."|two hours before and after marijuana cigarette smoking|all 31 completers|||units on a scale VAS 1-100 mm||Standard Error|Mean
2631424|NCT01844583|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|From the first dose through 30 days after administration of the last dose of study drug (up to 328 days)|The safety population included all participants who received at least 1 dose of alisertib. According to the protocol analysis planned, primary purpose of the study was to observe the drug-drug interaction of either esomeprazole or rifampin on the single-dose of alisertib.|||participants|||Number
2631425|NCT01844583|Secondary|Change From the Time-matched Baseline in the Fridericia Correction of QTc (QTcF)||Baseline, Days 1 and 10 multiple timepoints postdose (up to 24 hours) in Cycle 1|The electrocardiogram (ECG) QTc population included participants who received at least 1 dose of alisertib and have at least 1 post-baseline ECG.|||milliseconds (msec)||95% Confidence Interval|Mean
2631426|NCT01844583|Primary|Change From the Time-matched Baseline in the Individually Corrected QTc Interval (QTcI)||Baseline, Days 1 and 10 multiple timepoints postdose (up to 24 hours) in Cycle 1|The electrocardiogram (ECG) QTc population included participants who received at least 1 dose of alisertib and have at least 1 post-baseline ECG.|||milliseconds (msec)||95% Confidence Interval|Mean
2631427|NCT01844583|Primary|Phase Elimination Half-life (T1/2) for Alisertib in Presence and Absence of Rifampin||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm|The PK Population included participants who completed the protocol-specified dosing and PK sampling requirements in Cycle 1 and Cycle 2 to have sufficient dosing and plasma concentration-time data to permit calculation of PK parameters.|||hours||Standard Deviation|Mean
2631428|NCT01844583|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib in Presence and Absence of Rifampin||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm|The PK Population included participants who completed the protocol-specified dosing and PK sampling requirements in Cycle 1 and Cycle 2 to have sufficient dosing and plasma concentration-time data to permit calculation of PK parameters.|||hours||Full Range|Median
2631429|NCT01844583|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alisertib in Presence or Absence of Rifampin||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm|The PK Population included participants who completed protocol-specified dosing and PK sampling requirements in Cycle 1 and 2 to have sufficient dosing and plasma concentration-time data to permit calculation of PK parameters. Here number of participants analyzed are participants who were evaluable for this outcome measure at specified time points.|||hr*nmol/L||Standard Deviation|Mean
2631430|NCT01844583|Primary|AUC(Last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alisertib in Presence and Absence of Rifampin||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm|The PK Population included participants who completed the protocol-specified dosing and PK sampling requirements in Cycle 1 and Cycle 2 to have sufficient dosing and plasma concentration-time data to permit calculation of PK parameters.|||hr*nmol/L||Standard Deviation|Mean
2631431|NCT01844583|Primary|Cmax: Maximum Observed Concentration for Alisertib in Presence and Absence of Rifampin||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without rifampin arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with rifampin arm|The PK Population included participants who completed the protocol-specified dosing and PK sampling requirements in Cycle 1 and Cycle 2 to have sufficient dosing and plasma concentration-time data to permit calculation of PK parameters.|||nmol/L||Standard Deviation|Mean
2631432|NCT01844583|Primary|Terminal Phase Elimination Half-life (T1/2) for Alisertib in Presence and Absence of Esomeprazole||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm|The PK Population included participants who completed the protocol-specified dosing and PK sampling requirements in Cycle 1 and Cycle 2 to have sufficient dosing and plasma concentration-time data to permit calculation of PK parameters.|||hours||Standard Deviation|Mean
2631433|NCT01844583|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib in Presence and Absence of Esomeprazole||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm|The PK Population included participants who completed the protocol-specified dosing and PK sampling requirements in Cycle 1 and Cycle 2 to have sufficient dosing and plasma concentration-time data to permit calculation of PK parameters.|||hours||Full Range|Median
2631434|NCT01844583|Primary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alisertib in Presence and Absence of Esomeprazole||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm|The PK Population included participants who completed protocol-specified dosing and PK sampling requirements in Cycle 1 and 2 to have sufficient dosing and plasma concentration-time data to permit calculation of PK parameters. Here number of participants analyzed are participants who were evaluable for this outcome measure at specified time points.|||hr*nmol/L||Standard Deviation|Mean
2631435|NCT01844583|Primary|AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Alisertib in Presence and Absence of Esomeprazole||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm|The PK Population included participants who completed the protocol-specified dosing and PK sampling requirements in Cycle 1 and Cycle 2 to have sufficient dosing and plasma concentration-time data to permit calculation of PK parameters.|||hr*nmol/L||Standard Deviation|Mean
2631436|NCT01844583|Primary|Cmax: Maximum Observed Concentration for Alisertib in Presence and Absence of Esomeprazole||Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 1 for alisertib without esomeprazole arm; Day 8 pre-dose and at multiple time points (up to 72 hours) post-dose in Cycle 2 for alisertib with esomeprazole arm|The pharmacokinetic (PK) population included participants who completed the protocol-specified dosing and PK sampling requirements in cycle 1 and cycle 2 to have sufficient dosing and plasma concentration-time data to permit calculation of PK parameters.|||nmol/L||Standard Deviation|Mean
2631437|NCT01844531|Secondary|AUC0-tz for Metformin|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for Metformin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2631438|NCT01844531|Primary|Cmax for Metformin|Cmax (maximum measured concentration of the analyte in plasma) for Metformin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2631439|NCT01844531|Primary|Cmax for Empagliflozin|Cmax (maximum measured concentration of the analyte in plasma) for Empagliflozin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2631440|NCT01844531|Secondary|AUC0-tz for Empagliflozin|AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for Empagliflozin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2631441|NCT01844531|Primary|AUC0−∞ for Metformin|AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Metformin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2631442|NCT01844531|Primary|AUC0−∞ for Empagliflozin|AUC0−∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) for Empagliflozin|1hour (h) before drug intake and 20minutes (min),40min,1h,1h 30min,2h,2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h,10h,12h,24h,34h,48h,72h after drug intake|Pharmacokinetics set (PKS) included all treated subjects with at least 1 evaluable observation for at least 1 primary pharmacokinetic endpoint without important protocol violations relevant to the statistical evaluation of pharmacokinetics who had not taken any restricted medication and had not experienced emesis before or at 2 times median tmax|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2631443|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Positive Immunogenicity Response in the Cumulative Period|Overall number of participants with either a positive immunogenicity response for 'CTLA4 and possibly Ig' or 'Ig and/or Junction Region' relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose regardless of whether they discontinued early in the ST or LTE period, elected not to enter the LTE period, or completed both ST and LTE periods.|Day 1 to 6 months following discontinuation of treatment, up to March 2015|All participants, ages 6 to 17, who received at least one dose of study medication and who had at least one immunogenicity result reported after start of study medication|||participants|||Number
2631444|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Positive Immunogenicity Response in the Short Term Period|Overall number of participants with either a positive immunogenicity response for 'CTLA4 and possibly Ig' or 'Ig and/or Junction Region' relative to baseline. Sample draws for immunogenicity were scheduled at specific study days while on treatment for all subjects and at follow-up visits 28, 85, and 168 days after the last abatacept dose for those subjects who discontinued from the ST period or completed the ST study without continuing abatacept treatment.|Day 1 to 168 days after the last dose of study medication in the short-term period|All participants, ages 6 to 17, who received at least one dose of study medication and who had at least one immunogenicity result reported after start of study medication|||participants|||Number
2631445|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Adverse Events (AEs) of Special Interest in the Cumulative Period|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~AEs of special interest include infections, autoimmune disorders, malignancies, local injection site reactions and AEs within 24 hours of study drug administration.~The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 up to 56 days after last dose, up to March 2015|All treated participants, ages 6 to 17|||participants|||Number
2631446|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Adverse Events (AEs), Deaths, Serious AEs and AEs Leading to Discontinuation in the Cumulative Period|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 up to 56 days after last dose up to March 2015|All treated participants, ages 6 to 17|||participants|||Number
2631447|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Adverse Events (AEs) of Special Interest in the Short Term Period|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~AEs of special interest include infections, autoimmune disorders, malignancies, local injection site reactions and AEs within 24 hours of study drug administration.~The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 up to 56 days after last dose up to March 2015|All treated participants, ages 6 to 17|||participants|||Number
2631482|NCT01844375|Secondary|Nitrogen Balance|"24-hour urine urea nitrogen was measured on the postoperative day 3.~The urine samples during 24 hours on the postoperative day 3 were centrifuged (Cobas 8000 Modular Analyzer Series; Modular Pre-analytics Evo, Roche) at 3000 rpm for 5 min at 22.5°C, and measured using a urease/glutamate dehydrogenase coupled enzymatic technique (Cobas 8000 Modular Analyzer Series: C 702 Module, Roche). The nitrogen balance was calculated by measuring urinary urea nitrogen and dietary nitrogen intake during the same 24-hour period. The nitrogen intake was estimated for each patient following a doctor's diet order and types of food formulas in hospital, and then dividing the daily protein intake by 6.25. The urine urea nitrogen was added by 4 to account for non-urinary losses of nitrogen"|on the postoperative day 3||||mg/mL||Inter-Quartile Range|Median
2631448|NCT01844518|Secondary|Number of Participants (Ages 6 to 17) With Adverse Events (AEs), Deaths, Serious AEs (SAEs) and AEs Leading to Discontinuation in the Short Term Period|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v15.1) and graded using the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0."|Day 1 up to 56 days after last dose up to March 2015|All treated participants, ages 6 to 17|||participants|||Number
2631449|NCT01844518|Secondary|Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17|Evaluation of the trough concentration of abatacept (reported as geometric mean of Cmin) in all pk-evaluable participants at Days 57, 85 and 113 during a 4-month treatment period. Weight-tiered dosing groups are based on the first dose the participant received. Cmin is reported in microgram per milliliter (µg/mL).|Days 57, 85 and 113|All treated participants, ages 6 to 17, with PK-evaluable concentration data|||microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2631450|NCT01844518|Secondary|Percentage of Participants (Ages 6 to 17) Achieving American College of Rheumatology Pediatric 30 Response (ACRp30)|ACRp30 is defined as ≥30% improvement in at least 3 of the 6 juvenile idiopathic arthritis (JIA) core set variables [number of active joints, number of joints with limitation of motion (LOM), physician global assessment of disease activity, parent global assessment of patient overall well-being, functional ability as measured by the Children's Health Assessment Questionnaire (CHAQ) and C-reactive protein (CRP)] and ≥30% worsening in not more than 1 of the remaining 6 JIA core set variables.|Day 113|All participants, ages 6 to 17|||percentage of participants||95% Confidence Interval|Number
2631451|NCT01844518|Primary|Abatacept Trough Concentration (Cmin) in Participants Ages 6 to 17|Trough concentration of abatacept (reported as geometric mean of Cmin) in all pharmacokinetic (PK)-evaluable participants. Cmin is reported in microgram per milliliter (µg/mL). Desired target therapeutic Cmin should be >= 10 µg/mL.|Day 113|All treated participants, ages 6 to 17, with evaluable PK concentration data|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2631452|NCT01844505|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Functioning|Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation|All randomized participants with evaluable EORTC scores at baseline and specified time point|||Points on EORTC scale||Standard Deviation|Mean
2631453|NCT01844505|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Role Functioning|Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation|All randomized participants with evaluable EORTC scores at baseline and specified time point|||Points on EORTC scale||Standard Deviation|Mean
2631454|NCT01844505|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Emotional Functioning|Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation|All randomized participants with evaluable EORTC scores at baseline and specified time point|||Points on EORTC scale||Standard Deviation|Mean
2631455|NCT01844505|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cognitive Functioning|Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation|All randomized participants with evaluable EORTC scores at baseline and specified time point|||Points on EORTC scale||Standard Deviation|Mean
2631456|NCT01844505|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Social Functioning|Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline.|Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation|All randomized participants with evaluable EORTC scores at baseline and specified time point|||Points on EORTC scale||Standard Deviation|Mean
2631457|NCT01844505|Secondary|Mean Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status|Health Related Quality of Life was assessed using the EORTC QLQ-C30 questionnaire Version 3. With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better HRQoL; an increase from baseline indicates improvement in HRQoL compared to baseline. The mean score for all participants in an arm at a given week was subtracted from the mean score of the participants in that arm at baseline. Mean changes from baseline score is presented for all participants in an arm that remained on treatment and completed the EORTC-QLQ-C30 questionnaire at that time point.|Baseline and weeks 5, 7, 11, 13, 17, 19, 23, 25, then every 6 weeks until treatment discontinuation|All randomized participants with evaluable EORTC scores at baseline and specified time point|||Points on EORTC scale||Standard Deviation|Mean
2631458|NCT01844505|Secondary|Overall Survival Based on PD-L1 Expression Level|OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.|From randomization until date of death (Assessed up to September 2016, approximately 39 months)|All randomized participants with evaluable PD-L1 expression level at baseline|||months||95% Confidence Interval|Median
2631459|NCT01844505|Secondary|Progression-Free Survival Based on PD-L1 Expression Level|PD-L1 expression was defined as the percent of tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an IHC assay. Tumor biopsy specimens without measurable PD-L1 expression were classified as indeterminate if the staining was hampered for reasons attributed to the biology of the specimen and not because of improper specimen preparation or handling. Missing specimens, specimens that were not optimally collected (ie not evaluable), and all other specimens were classified as unknown. Participants must have been classified as PD-L1 >=5% or PD-L1 <5% per a verified IHC assay, or as indeterminate (ie not unknown), in order to be randomized.|From randomization until disease progression or death from any cause, whichever occurs first (Assessed up to September 2016, approximately 39 months)|All randomized participants with evaluable PD-L1 expression level at baseline|||months||95% Confidence Interval|Median
2631460|NCT01844505|Secondary|Objective Response Rate (ORR) Per Investigator Assessment|The ORR was defined as the number of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each arm. The BOR was defined as the best response designation, as determined by the Investigator, recorded between the date of randomization and the date of progression, as assessed by the Investigator per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurred first. For participants without evidence of RECIST 1.1 progression or subsequent anticancer therapy, all available response designations contributed to the BOR assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by >=50% of previously involved sites from nadir.|From randomization until date of disease progression or the date of subsequent anti-cancer therapy, whichever occurs first (Assessed up to February 2015, approximately 20 months)|All randomized participants|||Percentage of participants||95% Confidence Interval|Number
2631461|NCT01844505|Secondary|Overall Survival (OS)|OS data is presented as it was in Primary Outcome Measure #2. The statistical analysis following this outcome measure (#6) reports on a secondary objective comparing OS between the Nivolumab and Nivolumab + Ipilimumab arms.|From randomization to date of death (Assessed up to September 2016, approximately 39 months)|All randomized participants|||months||95% Confidence Interval|Median
2631462|NCT01844505|Secondary|Progression Free Survival (PFS)|PFS data is presented as it was in Primary Outcome Measure #1. The statistical analysis following this outcome measure (#5) reports on a secondary objective comparing PFS between the Nivolumab and Nivolumab + Ipilimumab arms.|From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)|All randomized participants|||months||95% Confidence Interval|Median
2631463|NCT01844505|Primary|Rate of Progression-Free Survival|PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Participants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.|6, 12, and 24 months|All randomized participants|||Percentage of participants||95% Confidence Interval|Number
2631464|NCT01844505|Primary|Rate of Overall Survival|OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. The overall survival rate at time T (6, 12, or 24 months) was defined as the probability that a participant was alive at time T following randomization.|6, 12, and 24 months|All randomized participants|||Probability of survival at Time T||95% Confidence Interval|Number
2631465|NCT01844505|Primary|Overall Survival (OS)|OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.|From randomization to date of death (Assessed up to September 2016, approximately 39 months)|All randomized participants|||months||95% Confidence Interval|Median
2631483|NCT01844375|Secondary|Change of Serum Glucose Concentration|Serum glucose concentrations will be measured preoperatively, and on the 24 hour postoperatively.|Baseline and postoperative 24 hours||||microunit/mL||Inter-Quartile Range|Median
2632077|NCT01838655|Secondary|Qualitative Change in Fundus Pigmentation at 9 Months Compared to Previous Visit.|Qualitative change in fundus pigmentation was measured as a binary endpoint (no change vs. increase) at Month 9 compared to Month 6|6 Months and 9 months||||Participants|||Count of Participants
2631466|NCT01844505|Primary|Progression Free Survival (PFS)|PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Progression is defined, using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants who started anti-cancer therapy without prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.|From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)|All randomized participants|||months||95% Confidence Interval|Median
2631467|NCT01844479|Secondary|Gait Speed Variability Dual Task|Gait speed variability (estimated using coefficient and variation of stride velocity) Dual task used a simultaneous mental task while walking.|Both footwear conditions up to thirty minutes||||percentage of gait||Standard Deviation|Mean
2631468|NCT01844479|Secondary|Gait Speed Variability Single Task|Gait speed variability (estimated using coefficient and variation of stride velocity) Single task means walking without a simultaneous mental task.|both footwear conditions up to 30 minutes||||percentage of gait||Standard Deviation|Mean
2631469|NCT01844479|Secondary|Medial and Lateral Center of Mass Displacement Dual Task|Mediolateral (side-to-side) center of mass displacement in deg2 (degrees squared) under dual task gait. Dual task used a simultaneous mental task while walking.|both footwear conditions up to 30 minutes||||deg2||Standard Deviation|Mean
2631470|NCT01844479|Secondary|Medial and Lateral Center of Mass Displacement Single Task|Mediolateral (side-to-side) center of mass displacement with displacement in deg2 (degrees squared) under single task gait conditions. Single task means walking without a simultaneous mental task.|under each foot where condition up to 30 minutes||||deg2||Standard Deviation|Mean
2631471|NCT01844479|Secondary|Double Support Time Dual Task Gait Initiation|percentage of stride time spent in double support time during dual task conditions and during gait initiation. Double support time refers to the time spent with both feet on the ground. Dual task used a simultaneous mental task while walking.|during each foot where condition up to 30 minutes||||percentage of stride time||Standard Deviation|Mean
2631472|NCT01844479|Secondary|Double Support Time Single Task|percentage of stride time spent in double support time during gait initiation. Double support time refers to the time spent with both feet on the ground. Single task means walking without a simultaneous mental task.|during each foot where condition up to 30 minutes||||percentage of stride time||Standard Deviation|Mean
2631473|NCT01844479|Secondary|Stride Velocity - Dual Task|Stride velocity during steady state dual task. Dual task used a simultaneous mental task while walking.|during each foot wear condition up to 30 minutes||||m/s||Standard Deviation|Mean
2631474|NCT01844479|Secondary|Gait Initiation - Dual Task|The number of steps taken to reach steady state walking under dual task. Dual task used a simultaneous mental task while walking.|during each foot wear condition up to 30 minutes||||Number of steps||Standard Deviation|Mean
2631475|NCT01844479|Other Pre-specified|Sudomotor Function|Sudomotor function will be measured by electrical sweat conductance (ESC), as expressed in microSiemens (µS).|at baseline, this is a single visit study expected to last one hour||||µS||Standard Deviation|Mean
2631476|NCT01844479|Other Pre-specified|Stride Velocity - Single Task|Stride velocity steady state gait single task. Single task means walking without a simultaneous mental task.|during each foot wear condition up to 30 minutes||||meters/second||Standard Deviation|Mean
2631477|NCT01844479|Secondary|Gait Initation - Single Task|The number of steps taken to reach steady state walking under single task. Single task means walking without a simultaneous mental task.|during each foot wear condition up to 30 minutes||||Number of steps||Standard Deviation|Mean
2631478|NCT01844479|Primary|Plantar Foot Temperature Changes in Regions-of-interest in Response to Walking|Plantar foot temperature changes in regions-of-interest in response to walking 200 steps will be measured in each footwear condition and compared to baseline.|baseline and after 200 steps in each condition, this is a single visit study expected to last one hour||||Absolute change in temperature degrees||Standard Deviation|Mean
2631479|NCT01844388|Other Pre-specified|Reason for Contact Lens Replacement|The reason the contact lens needed to be replaced was recorded for each eye. The following categories are reported: Scheduled Replacement, Discomfort, Lens Damage, Unacceptable Vision and Lens Lost. There may be multiple reasons for replacement of the contact lens for a single eye.|Day 90|Completed population included all enrolled participants who received study treatment and completed the study through Day 90.|||eyes|Contact Lenses Replaced||Number
2631480|NCT01844388|Other Pre-specified|Average Daily Contact Wearing Time|The average reported number of hours per day that contact lenses were worn by participants during the previous 7 days.|Day 90|Completed population included all enrolled participants who received study treatment and completed the study through Day 90.|||hours per day||Standard Deviation|Mean
2631481|NCT01844388|Primary|Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline|Contact lens distance visual acuity was measured for each eye using the LogMAR visual acuity eye chart. The worse eye at Baseline was used for analysis. A change of 0.1 on the LogMAR scale was equivalent to a 1 line change in visual acuity. The following categories are reported: Better=an increase in 2 or more lines, No Change=a change of +/- 1 line, and Worse=a decrease of 2 lines or more.|Baseline, Day 90|Intent-to-treat Population included all randomized participants.|||percentage of participants|||Number
2631513|NCT01844284|Secondary|Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))|"- Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2637098|NCT01785095|Secondary|Number of Oocytes Retrieved|the number of oocytes retrieved in the first cycle and in the second cycle are compared.|after 2 weeks of treatment||||oocytes||Standard Deviation|Mean
2631484|NCT01844375|Primary|Meters Walked During 2-Minute Walk Test|Primary outcomes are 2-minute walk test (2MWT) which will be measured before surgery to be a baseline, and then 2MWT will be measured at 72 hours after surgery. Patients will be asked to walk back and forth along a 15 m stretch of hallway as much as they can over a period of 2 minutes. To ensure safety, the evaluator walks behind the patient. Patients are told that they can rest if necessary, and they are allowed to use their regular walking aids. Any intravenous lines, tubes, or infusion pumps will be attached to a pole and pushed by the patient. The walking distance will be recorded in meters. If the patient is unwilling or unable to walk, the reason will be recorded and the distance '0' will be recorded for that day.|72 hours after surgery||||meters||Inter-Quartile Range|Median
2631485|NCT01844284|Secondary|Number of Participants With Non-Target Vessel MI (NTV-MI)||5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631486|NCT01844284|Secondary|Number of Participants With Not Ischemia-driven TLR (NID-TLR)||5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631487|NCT01844284|Secondary|Number of Participants With Cardiac Death, All MI, ID-TLR (MACE)||5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631488|NCT01844284|Secondary|Change in Average Lumen Diameter (ALD), Between Pre- and Post-nitrate Injection by Angiography (Superiority)|Nitrate injection is: Nitrate induced vaso-dilatation|3 years||2019-12-31|12/2019||||
2631489|NCT01844284|Secondary|Change in Average Lumen Area (ALA), From Post-procedure to 3 Years by Intravascular Ultrasound (IVUS) (Superiority)||3 years||2019-12-31|12/2019||||
2631490|NCT01844284|Secondary|Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Post-Nitroglycerin (NTG)|Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure.|2 years|Full Analysis Set Population|||millimetre||Standard Deviation|Mean
2631491|NCT01844284|Secondary|Nitrate Vaso-reactivity Analysis/ In-device Mean Lumen Diameter: Absolute Vaso Dilatation|"Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure.~Absolute Vaso dilatation = Post Nitroglycerin (NTG) - Pre Nitroglycerin (NTG)"|2 years|Full Analysis Set Population|||millimetre||Standard Deviation|Mean
2631492|NCT01844284|Secondary|Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Pre-Nitroglycerin (NTG)|Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure.|2 years|Full Analysis Set Population|||millimetre||Standard Deviation|Mean
2631493|NCT01844284|Secondary|In-segment Late Loss (Non-inferiority)||13 months|Full Analysis Set Population|||Participants|||Count of Participants
2631494|NCT01844284|Secondary|Number of Participants With Stent/Scaffold Thrombosis|"ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation~Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation~Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation~Very late scaffold/stent thrombosis: >1 year post stent implantation"|Very Late (1461 - 1825 days)|Stent/scaffold thrombosis event rates were determined according to the the analysis population with excluding subjects who are lost to follow-up through given time point without any Stent/Scaffold Thrombosis event.|||Participants|||Count of Participants
2631495|NCT01844284|Secondary|Number of Participants With Stent/Scaffold Thrombosis|"ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation~Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation~Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation~Very late scaffold/stent thrombosis: >1 year post stent implantation"|Very Late (1096 - 1460 days)|Stent/scaffold thrombosis event rates were determined according to the the analysis population with excluding subjects who are lost to follow-up through given time point without any Stent/Scaffold Thrombosis event.|||Participants|||Count of Participants
2631496|NCT01844284|Secondary|Number of Participants With Stent/Scaffold Thrombosis|"ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation~Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation~Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation~Very late scaffold/stent thrombosis: >1 year post stent implantation"|Very Late (731 - 1095 days)|Stent/scaffold thrombosis event rates were determined according to the the analysis population with excluding subjects who are lost to follow-up through given time point without any Stent/Scaffold Thrombosis event.|||Participants|||Count of Participants
2631497|NCT01844284|Secondary|Number of Participants With Stent/Scaffold Thrombosis|"ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation~Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation~Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation~Very late scaffold/stent thrombosis: >1 year post stent implantation"|Very Late (366 - 730 days)|Stent/scaffold thrombosis event rates were determined according to the the analysis population with excluding subjects who are lost to follow-up through given time point without any Stent/Scaffold Thrombosis event.|||Participants|||Count of Participants
2631570|NCT01844284|Secondary|Number of Participants With Target Lesion Failure (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|1 month|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631498|NCT01844284|Secondary|Number of Participants With Stent/Scaffold Thrombosis|"ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation~Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation~Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation~Very late scaffold/stent thrombosis: >1 year post stent implantation"|Late (31 - 365 days)|Stent/scaffold thrombosis event rates were determined according to the the analysis population with excluding subjects who are lost to follow-up through given time point without any Stent/Scaffold Thrombosis event.|||Participants|||Count of Participants
2631499|NCT01844284|Secondary|Number of Participants With Stent/Scaffold Thrombosis|"ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation~Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation~Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation~Very late scaffold/stent thrombosis: >1 year post stent implantation"|Subacute (>1 - 30 days)|Stent/scaffold thrombosis event rates were determined according to the the analysis population with excluding subjects who are lost to follow-up through given time point without any Stent/Scaffold Thrombosis event.|||Participants|||Count of Participants
2631500|NCT01844284|Secondary|Number of Participants With Stent/Scaffold Thrombosis|"ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.~Timings:~Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation~Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation~Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation~Very late scaffold/stent thrombosis: >1 year post stent implantation"|Acute (≤ 1 day)|Stent/scaffold thrombosis event rates were determined according to the the analysis population with excluding subjects who are lost to follow-up through given time point without any Stent/Scaffold Thrombosis event.|||Participants|||Count of Participants
2631501|NCT01844284|Secondary|Number of Participants With Target Vessel MI (TV-MI)||5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631502|NCT01844284|Secondary|Number of Participants With Target Vessel MI (TV-MI)||4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631503|NCT01844284|Secondary|Number of Participants With Target Vessel MI (TV-MI)||3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631504|NCT01844284|Secondary|Number of Participants With Target Vessel MI (TV-MI)||2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631505|NCT01844284|Secondary|Number of Participants With Target Vessel MI (TV-MI)||1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631506|NCT01844284|Secondary|Number of Participants With Target Vessel MI (TV-MI)||6 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631507|NCT01844284|Secondary|Number of Participants With Target Vessel MI (TV-MI)||1 month|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631508|NCT01844284|Secondary|Number of Participants With Target Vessel MI (TV-MI)||≤ 7 days post index procedure (In-hospital )|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631509|NCT01844284|Secondary|Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))|"- Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631510|NCT01844284|Secondary|Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))|"- Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631511|NCT01844284|Secondary|Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))|"- Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631512|NCT01844284|Secondary|Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))|"- Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631898|NCT01840345|Secondary|Pain|"Pain intensity will be measured by using the 100-point Visual Analogue Scale, a 100-mm horizontal line with anchors of no pain at all (at 0) and worst pain imaginable (at 100mm) on which patients' pain intensities are measured."|Baseline, 4 weeks||||mm on 100 mm scale||Standard Deviation|Mean
2631514|NCT01844284|Secondary|Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))|"- Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|6 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631515|NCT01844284|Secondary|Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))|"- Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|1 month|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631516|NCT01844284|Secondary|Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))|"- Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|≤ 7 days post index procedure (In-hospital )|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631517|NCT01844284|Secondary|Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)|"Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment.~Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631518|NCT01844284|Secondary|Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)|"Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment.~Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631519|NCT01844284|Secondary|Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)|"Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment.~Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631520|NCT01844284|Secondary|Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)|"Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment.~Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631521|NCT01844284|Secondary|Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)|"Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment.~Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631522|NCT01844284|Secondary|Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)|"Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment.~Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|6 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631542|NCT01844284|Secondary|Number of Participants With Ischemia-driven TVR (ID-TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2667676|NCT01513122|Secondary|Mean Total Cholesterol Changes From Baseline to 48 Weeks||48 weeks||||mmol/L||95% Confidence Interval|Mean
2631523|NCT01844284|Secondary|Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)|"Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment.~Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|1 month|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631524|NCT01844284|Secondary|Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)|"Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment.~Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|≤ 7 days post index procedure (In-hospital )|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631525|NCT01844284|Secondary|Number of Participants With Ischemia-driven Revascularization (ID-TLR)|"A revascularization is considered ischemia-driven if associated with any of the following:~Positive functional ischemia study including positive FFR~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study"|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631526|NCT01844284|Secondary|Number of Participants With Ischemia-driven Revascularization (ID-TLR)|"A revascularization is considered ischemia-driven if associated with any of the following:~Positive functional ischemia study including positive FFR~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study"|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631527|NCT01844284|Secondary|Number of Participants With Ischemia-driven Revascularization (ID-TLR)|"A revascularization is considered ischemia-driven if associated with any of the following:~Positive functional ischemia study including positive FFR~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study"|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631528|NCT01844284|Secondary|Number of Participants With Ischemia-driven Revascularization (ID-TLR)|"A revascularization is considered ischemia-driven if associated with any of the following:~Positive functional ischemia study including positive FFR~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study"|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631529|NCT01844284|Secondary|Number of Participants With Ischemia-driven Revascularization (ID-TLR)|"A revascularization is considered ischemia-driven if associated with any of the following:~Positive functional ischemia study including positive FFR~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study"|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631530|NCT01844284|Secondary|Number of Participants With Ischemia-driven Revascularization (ID-TLR)|"A revascularization is considered ischemia-driven if associated with any of the following:~Positive functional ischemia study including positive FFR~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study"|6 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631531|NCT01844284|Secondary|Number of Participants With Ischemia-driven Revascularization (ID-TLR)|"A revascularization is considered ischemia-driven if associated with any of the following:~Positive functional ischemia study including positive FFR~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study"|1 month|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631532|NCT01844284|Secondary|Number of Participants With Ischemia-driven Revascularization (ID-TLR)|"A revascularization is considered ischemia-driven if associated with any of the following:~Positive functional ischemia study including positive FFR~Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA~Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study"|≤ 7 days post index procedure (In-hospital )|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631533|NCT01844284|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631534|NCT01844284|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631535|NCT01844284|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631536|NCT01844284|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631537|NCT01844284|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631538|NCT01844284|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|6 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631539|NCT01844284|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|1 month|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631540|NCT01844284|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|≤ 7 days post index procedure (In-hospital )|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631541|NCT01844284|Secondary|Number of Participants With Ischemia-driven TVR (ID-TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2632078|NCT01838655|Secondary|Qualitative Change in Fundus Pigmentation at 6 Months Compared to Previous Visit.|Qualitative change in fundus pigmentation was measured as a binary endpoint (no change vs. increase) at Month 6 compared to Month 3|3 Months and 6 months||||Participants|||Count of Participants
2631543|NCT01844284|Secondary|Number of Participants With Ischemia-driven TVR (ID-TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631544|NCT01844284|Secondary|Number of Participants With Ischemia-driven TVR (ID-TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631545|NCT01844284|Secondary|Number of Participants With Ischemia-driven TVR (ID-TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631546|NCT01844284|Secondary|Number of Participants With Ischemia-driven TVR (ID-TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|6 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631547|NCT01844284|Secondary|Number of Participants With Ischemia-driven TVR (ID-TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|1 month|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631548|NCT01844284|Secondary|Number of Participants With Ischemia-driven TVR (ID-TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|≤ 7 days post index procedure (In-hospital )|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631549|NCT01844284|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631550|NCT01844284|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631551|NCT01844284|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631552|NCT01844284|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631553|NCT01844284|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631554|NCT01844284|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|6 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631555|NCT01844284|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|1 month|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631556|NCT01844284|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|≤ 7 days post index procedure (In-hospital )|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631557|NCT01844284|Secondary|Number of Participants With Cardiac Death/All MI|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631558|NCT01844284|Secondary|Number of Participants With Cardiac Death/All MI|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631559|NCT01844284|Secondary|Number of Participants With Cardiac Death/All MI|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631560|NCT01844284|Secondary|Number of Participants With Cardiac Death/All MI|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631561|NCT01844284|Secondary|Number of Participants With Cardiac Death/All MI|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631562|NCT01844284|Secondary|Number of Participants With Cardiac Death/All MI|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|6 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631563|NCT01844284|Secondary|Number of Participants With Cardiac Death/All MI|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|1 month|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631564|NCT01844284|Secondary|Number of Participants With Cardiac Death/All MI|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|≤ 7 days post index procedure (In-hospital )|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631565|NCT01844284|Secondary|Number of Participants With Target Lesion Failure (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631566|NCT01844284|Secondary|Number of Participants With Target Lesion Failure (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631567|NCT01844284|Secondary|Number of Participants With Target Lesion Failure (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631571|NCT01844284|Secondary|Number of Participants With Target Lesion Failure (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|≤ 7 days post index procedure (In-hospital )|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631572|NCT01844284|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631573|NCT01844284|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631574|NCT01844284|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631575|NCT01844284|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631576|NCT01844284|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631577|NCT01844284|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|6 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631578|NCT01844284|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|1 month|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631579|NCT01844284|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|≤ 7 days post index procedure (In-hospital )|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631580|NCT01844284|Secondary|Number of Participants With Any Death/Any MI/Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631581|NCT01844284|Secondary|Number of Participants With Any Death/Any MI/Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631582|NCT01844284|Secondary|Number of Participants With Any Death/Any MI/Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631583|NCT01844284|Secondary|Number of Participants With Any Death/Any MI/Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631584|NCT01844284|Secondary|Number of Participants With Any Death/Any MI/Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631585|NCT01844284|Secondary|Number of Participants With Any Death/Any MI/Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|6 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631586|NCT01844284|Secondary|Number of Participants With Any Death/Any MI/Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|1 month|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631587|NCT01844284|Secondary|Number of Participants With Any Death/Any MI/Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|≤ 7 days post index procedure (In-hospital )|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2631588|NCT01844284|Primary|Number of Participants With Target Lesion Failure (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2632013|NCT01838863|Post-Hoc|Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG) maximum amplitude (MA).|after injury and prior to hospital arrival, at about 15 minutes after injury||||millimeter (mm)||Inter-Quartile Range|Median
2631589|NCT01844206|Primary|The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery|The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups.|Up to 48 hours post-operatively|"Data could not be summarized to include in the data table because only 5 out of 140 subjects were enrolled prior to study termination, and no data analysis was carried out. As instructed, we are specifying zero (0) for the Number of Participants Analyzed in each Arm/Group and leaving the data fields blank."||||||
2631590|NCT01844115|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe).|Baseline to Week 8|The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of the HAM-A.|||Score on scale||Standard Deviation|Mean
2631591|NCT01844115|Primary|Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score|The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.|Baseline to Week 8|The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of the HAM-A.|||Score on Scale||Standard Deviation|Mean
2631592|NCT01843972|Primary|Frequency of Subjects With Drug-related Adverse Events (Part I)|Frequency of subjects with drug-related Adverse Events (AEs) (Part I)|Part I: 'Day1 to Day21 for Dose 1, 2,3 &4 and Day1 to Day45 for Dose group 5,6 & 7|Treated Set (TS): all subjects who were documented to have taken at least 1 dose of study medication.|||Participants|||Number
2631593|NCT01843972|Secondary|Tmax (Part I)|"tmax (time from dosing to maximum measured concentration of BI 691751) (part I)~Time frame:~Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin~Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin~Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin~Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h|PKS|||h||Full Range|Median
2631594|NCT01843972|Secondary|t1/2 (Part I)|"t1/2 (terminal half-life of the analyte of BI 691751 in plasma) (part I)~Time frame:~Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin~Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin~Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin~Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h|Pharmacokinetic (PK) set (PKS) which includes all subjects of the treated set were were randomised to active treatment in the single rising dose part of bioavailability part, and had no important protocol violations relevant for the statistical evaluation of further PK parameters. Only subjects with calculable PK parameter were analysed.|||h||Geometric Coefficient of Variation|Geometric Mean
2631595|NCT01843972|Secondary|AUC0-tz|"AUC0-tz (area under the concentration-time curve of BI 691751 in plasma over the time interval from 0 up to the last quantifiable data point) (Part I and Part II)~Time frame:~Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin~Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin~Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin~Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|Part 1: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 7: up to 720h; Part 2: up to 720h|PPS-DP for part I and PPS-BA for part II. Only subjects with calculable PK parameter were analysed.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2631596|NCT01843972|Secondary|AUC0-infinity (Part I)|"AUC0-infinity (area under the concentration-time curve of BI 691751 in plasma over the time interval from 0 extrapolated to infinity) (part I)~Time frame:~Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin~Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin~Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin~Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h|PPS-DP. Only subjects with calculable PK parameter were analysed.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2631629|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 4|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 4|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Participants|||Number
2631597|NCT01843972|Secondary|Cmax (Part I)|"Cmax (maximum measured concentration of BI 691751 in plasma) (part I)~Time frame:~Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin~Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin~Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin~Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin"|for dose 1 & 2: up to 168h, for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h|Per protocol set for evaluation of dose proportionality (PPS-DP): This subject set includes all subjects of the TS who were randomised to active treatment in the single rising dose part or BA part, and had no important PVs relevant for the statistical evaluation of dose proportionality. Only subjects with calculable PK parameter were analysed.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2631598|NCT01843972|Primary|Cmax (Part II)|Cmax (maximum measured concentration of the analyte of BI 691751 in plasma) (part II)|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug administration|PPS-BA. Only subjects with calculable PK parameter were analysed.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2631599|NCT01843972|Primary|AUC0-72h (Part II)|"AUC0-72h (area under the concentration-time curve of the analyte of BI 691751 in plasma over the time interval from 0 to 72 h) (part II).~PPS-BA included all subjects in the TS who were randomised to the BA part, who provided at least one observation for at least one primary endpoint, had no important protocol violations relevant for the statistical evaluation of BA and did not experience emesis at or before twice the median tmax."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h and 72h after drug administration|Per protocol set for evaluation of bioavailability (PPS-BA). Only subjects with calculable PK parameter were analysed.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2631600|NCT01843933|Primary|Abnormal ETCO2 Values, Abnormal Pulse Oximetry Values, and Staff Interventions|"Mild Events/Interventions:~Mild oxygen desaturation: Pulse oximetry < 93% on room air or <95% on oxygen~Hypopneic hypoventilation: ETCO2 values < 30mmHg for >30 seconds~Bradypneic hypoventilation: ETCO2 values > 50mmHg for >30 seconds~Stimulation: Verbally or physical stimulation to encourage breathing~Moderate Events/Interventions:~Moderate oxygen desaturation: Pulse oximetry < 85% on room air or <90% on oxygen~Apnea: ETCO2 value of 0mmHg or respiratory rate of 0 for >20 seconds~Airway obstruction: ETCO2 value of 0mmHg without cessation of respiratory effort~Airway repositioning: Jaw thrust or chin lift or use of a shoulder roll~Airway adjunct: Oral or nasal airway device~Severe Events/Interventions:~Severe oxygen desaturation: Pulse oximetry < 80% on room air or <85% on oxygen~Assisted ventilation: Use of a bag-valve mask, a laryngeal mask airway or endotracheal intubation~Reversal medications: Use of naloxone or flumazenil"|Post operative period (From entering the PACU until discharge. Average time is 1 hour)||||participants|||Number
2631601|NCT01843920|Secondary|Number of Participants With Return of Intraocular Pressure to Normal Levels|Number of participants with a normal intraocular pressure of 10-21 mm Hg at the Month 2 visit|Month 2||||Participants|||Count of Participants
2631602|NCT01843920|Primary|Complete Resolution of Intraocular Gas Bubble|This will be reported by the patient when they see/feel the gas bubble disappear.|Following surgery, until gas bubble is gone. Up to 2 months.||||Duration in days, gas bubble||Full Range|Mean
2631603|NCT01843842|Secondary|Percentage of Patients With Exacerbation of the Disease Course|The development of disease complications requiring antibiotics administration or hospitalization|On days 1-6 of observation|Per Protocol set.|||percentage of participants|||Number
2631604|NCT01843842|Secondary|Number of Intakes of Antipyretics if Indicated|Based on data mentioned in a patient's diary|On day 1, 2, 3, 4 and 5 of the treatment|Per Protocol set.|||Number of intakes||Standard Deviation|Mean
2631605|NCT01843842|Secondary|"Severity of the Disease Within 6 Days Was Assessed Using the Area Under the Curve for the Total Symptom Score (TSS)"|"The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom.~The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest).~The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С).~Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Days 1, 3, 6; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5."|On days 1-6 of observation|Per Protocol set.|||AUC score*day||Standard Deviation|Mean
2631606|NCT01843842|Secondary|Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data|"Acute respiratory infection (ARI) symptoms include 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest).~The ARI symptoms was recorded by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5."|baseline and days 2, 3, 4 and 5 of observation|Per Protocol set.|||hours||Standard Deviation|Mean
2631630|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 3|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 3|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Participants|||Number
2631631|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 2|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 2|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Participants|||Number
2631607|NCT01843842|Secondary|Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)|"The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom.~The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest).~The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С).~Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Day 3; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 2-5."|on Days 2, 3, 4, 5 of Observation|Per Protocol set|||Score||Standard Deviation|Mean
2631608|NCT01843842|Secondary|Percentage of Patients With Normal Body Temperature (≤37.0ºС)|Axillary temperature (morning and evening) decline to or below 37.0 ºС|On day 2, 3, 4, 5 of observation|Per Protocol set.|||percentage of participants|||Number
2631609|NCT01843842|Secondary|Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline)||baseline and days 2, 3, 4 and 5 of observation|Per Protocol set. The morning temperature in 13 patients (7 in the Ergoferon group and 6 in the placebo group) was excluded from the analysis due to mistakes in diaries.|||°C||Standard Deviation|Mean
2631610|NCT01843842|Primary|Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data)|Based on the data mentioned in a patient's diary|On day 2, 3 and 4 of observation|Per Protocol set|||percentage of participants|||Number
2631611|NCT01843803|Secondary|All Participants Assessed by Informed Decision Making (IDM). The IDM Tool Measures the Extent to Which Decision Making Involving Patient and Provider by Analyzing Recordings of Encounters Between Providers and Patients.|IDM includes 7 elements of a complete decision: discussion of patient's role in decision making, clinic issue or nature of the decision, alternatives, pros and cons, uncertainties, patient understanding, and patient preference. A score between 0-7 is assigned based audio-recording. A higher score is expected for a more complex decision (decisions are categorized as basic, intermediate or complex). For basic decisions (e.g. refilling a medication) a score of 2-3 would indicate a good IDM event, an intermediate decision (e.g., prescribing use of new equipment) should result in a score of 5-6; and a complex decision (e.g. lifestyle counseling) would receive a score of 7 if all the elements of the IDM were noted. We will look at the distribution of the decisions by group to determine whether the decision complexity differs by whether or not patients complete the inventory. Also, we will look at the average IDM score by decision complexity and study group.|based on audio-recordings of the patient-provider encounter, no additional time required by participants, through study completion|A subset of cases were coded using the IDM tool.|||Participants|||Count of Participants
2631612|NCT01843803|Secondary|% of Encounters in Which Provider Probed at Least Once for Contextual Information|This methodology assesses patient centered clinical decision making using Content Coding for Contextual Care (4C). 4C evaluates encounters based on whether the provider probes at least once for clinically relevant content and then plans care accordingly.|based on audio-recordings of the patient-provider encounter, no additional time required by participants|Mixed Effects Logistic Regression Analysis controlling for covariates (demographics, comorbid conditions) on whether or not providers probed at least once for additional information based on whether or not the patient was in the intervention group that used the inventory tool|||proportion of cases probed|was encounter probed by provider|95% Confidence Interval|Number
2631613|NCT01843803|Secondary|Consultation Care Measure (CCM)|CCM measures the patient's perceptions of patient-centered care during their last visit with their provider. there are 5 subscales in 21 items: communication and partnership, personal relationship, health promotion, positive and clear approach to the problem, interest in effect on life. Items are scores on a 4-point likert scale from 1-very strongly agree to 4=neutral/disagree. The average of the ratings for each subscale is determined, so the score for each subscale ranges from 1.0 to 4.0.|immediately following the encounter with the provider, 5-7 minutes to complete||||units on a scale||Standard Error|Least Squares Mean
2631614|NCT01843803|Primary|Consultation and Relational Empathy (CARE) Measure|CARE is a process measure of empathy and holistic care in the context of a therapeutic relationship (medical visit). It has 10 items, each rated from poor to excellent. Example items include: How was the provider at 'making you feel at ease'; letting you tell your story.' Score are added for a maximum of 50, min of 10; higher score reflects greater patient-centeredness.|Total time of patient participation 2 to 2.5 hours, including 1 hour prior to provider encounter, encounter (20-40 min) and data collection after encounter (15-30 minutes).||||units on a scale||Standard Error|Least Squares Mean
2631615|NCT01843777|Secondary|Difference Between Pre-intervention and Post-intervention Total Score on International Outcome Inventory for Hearing Aids|The total score from the International Outcome Inventory for Hearing Aids (IOI-HA; Cox et al., 2000) was used to assess overall hearing-aid outcome. This measure consists of seven items assessing (1) daily hearing-aid use, (2) benefit, (3) residual activity limitation, (4) satisfaction, (5) residual participation restriction, (6) impact (of hearing impairment) on others, and (7) quality of Life. Responses to each question range from 1 (poorest) to 5 (best), for a total score range from 7 points to 35 points. The reported measurement was the change in total score from pre-intervention to post-intervention, with a maximum possible change of 28 points.|Collected twice once at pre-intervention visit and once at a post-intervention visit occurring four to six weeks following the intervention|In the standard-of-care group, one subject withdrew from the study prior to the collection of outcome measures. In the treatment group, one subject did not answer one of the questions on the baseline questionnaire, thereby preventing calculation of a total score. This subject's data is therefore not included in the analysis.|||units on a scale||Standard Deviation|Mean
2631632|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 1|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 1|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Participants|||Number
2631616|NCT01843777|Primary|Difference in Hours of Hearing Aid Use Between Pre-intervention and Post-intervention|Hearing aid use was measured by the number of hours of use recorded in the hearing-aid software. This was measured on up to four occasions: Visit #1 to #3 (pre-intervention), and Visit #4 (post-intervention). Average daily hours of hearing aid use was documented at each time point, so that the Visit #4 observation is a measure of the average daily use between the start of intervention (Visit #3) and visit #4. Data logger results were averaged between the left and right hearing aids at each time point and across all three pre-intervention time points.|Collected pre-intervention and again at post-intervention appointment occurring between four and six weeks after the intervention date|"Standard-of-care group: one subject withdrew prior to the collection of outcome measures and one subject did not give valid data log measurement. These subjects are not included.~Treatment: Three subjects did not give valid outcome data log measurement and one did not give a valid baseline measure. These subjects are not included."|||hours||Standard Deviation|Mean
2631617|NCT01843751|Secondary|Number of Emergency Room Visits|Number of emergency room visits over 6 months|6 months|Many participants lost to follow up (9 in physician group, 5 in specialist group) who did not provide 6 month follow up data.|||visits||Full Range|Mean
2631618|NCT01843751|Secondary|Human Immunodeficiency Virus (HIV) Risk Behavior Assessment by Assessing Change in Risk Assessment Battery (RAB) Score|"The RAB is a self-administered, multiple choice questionnaire. It offers a quick and confidential assessment of both needle sharing practices and sexual activity associated with HIV transmission.~The RAB is composed of 45 simple questions which uses discrete response. The questions have different numbers of items, and scores for a single question can range from 0 to 7, with higher values reflecting more instances of risk behavior. The RAB is scored by adding the values that correspond to the responses selected by the subject for the items. This total score is then divided by 40, the highest possible score for the overall instrument, yielding a score from 0 to 1.~HIV risk behaviors will be assessed via score on the Risk Assessment Battery at baseline and month 6--difference between baseline and month 6."|baseline and 6 months|Many subjects did not complete measurement at 6 months: 10 in physician office arm; 5 in specialist arm|||score on a scale||Full Range|Mean
2631619|NCT01843751|Secondary|Initiation of Medication Assisted Treatment|Initiation of medication assisted treatment (yes/no)|6 months||||Participants|||Count of Participants
2631620|NCT01843751|Secondary|Number of Days From Treatment Initiation to First Drug Use|Number of days from treatment initiation to first drug use thereafter|6 months||||days||Full Range|Mean
2631621|NCT01843751|Primary|Number of Participants With New Crime|The primary outcome will be measured via the publicly available Wisconsin Circuit Court Consolidated Court Automation Program (CCAP) database. The Wisconsin Circuit Court Access website provides access to certain public records of the circuit courts of Wisconsin. The information displayed on the website is an exact copy of the case information entered into CCAP case management system by court staff in the counties where the case files are located. The court record summaries viewed are all public records under Wisconsin open records law and freely accessible to the public. The CCAP database will searched periodically for all enrolled study participants until data analysis has been complete.|2 years||||Participants|||Count of Participants
2631622|NCT01843673|Primary|Greater Than or Equal to 5% Variation of Normal Tissue Toxicity||Up to 7 weeks|No data analyzed due to staff leaving primary institution.||||||
2631623|NCT01843673|Primary|Dose Variation Between the Different Imaging Technologies for Normal Tissue Structures of 10%||Up to 7 weeks|No data analyzed due to staff leaving primary institution.||||||
2631624|NCT01843673|Primary|Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies|The automated patient setup procedure varies between 'OBI', 'CBCT' or 'Exactrac' imaging technologies. Each procedure gives two shifts: 'vertical' and 'lateral'. In the absence of a gold standard, our goal is to compare the shifts recommended by each pair of automated patient setup procedures. Average and Std deviation of vertical and lateral motion from the three systems were computed. P value, 1.00, refers to the test of difference of each system with OBI being more than 2 mm. Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. The reported mean value represents the shift from planned treatment position averaged over all daily treatment setups. A negative mean vertical value indicates the patient was consistently set up posterior to plan; a negative mean lateral value indicates a set up consistently right of plan.|up to 7 weeks|Ten evaluable head and neck patients treated with external beam radiation therapy received 19 to 32 fractions with all three imaging techniques. The mean daily shift of these 19 to 32 fractions were recorded for each technique. Statistical significance is determined based on 5% level of significance.|||mm||Standard Deviation|Mean
2631625|NCT01843660|Secondary|Number of Participants With Overall Analgesic Satisfaction Score|Participants and physicians separately evaluated their satisfaction with the analgesic effect of the study drug using a 5-point scale (1=very unsatisfied, 2 =unsatisfied, 3=average, 4= satisfied and 5=very satisfied). Number of participants in each category was reported.|Hour 6|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Participants|||Number
2631626|NCT01843660|Secondary|Number of Participants With Analgesic Satisfaction Score|Participants evaluated their satisfaction with the analgesic effect of the study drug using a 4-point scale (4=very good, 3=good, 2=average, 1=poor). Number of participants in each category was reported.|Hour 6|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Participants|||Number
2631627|NCT01843660|Secondary|Number of Participants Who Required Additional Dosage Administration|Number of participants who additionally required a second tablet within 2 hours after the first administration of the investigational drug was reported.|Baseline up to Hour 2|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Participants|||Number
2631628|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 6|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 6|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Participants|||Number
2632024|NCT01838863|Other Pre-specified|Exploratory Analyses in a Sub-group With Severe Traumatic Brain Injury (TBI)|Number of participants with 28-day mortality. Traumatic brain injury (TBI) is defined as Abbreviated Injury Score (AIS) for Head/Neck >=3.|Hospital stay up to 28 days.||||Participants|||Count of Participants
2631633|NCT01843660|Primary|Number of Participants With Pain Relief Score at Hour 0.5|Pain relief was measured using 6-point Likert Scale (4=complete, 3=significant/comparatively large, 2=moderate, 1=mild/slight, 0=none, -1=exacerbated/heavier).|Hour 0.5|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Participants|||Number
2631634|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 6|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 6|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Units on a scale||Standard Deviation|Mean
2631635|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 4|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 4|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Units on a scale||Standard Deviation|Mean
2631636|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 3|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 3|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Units on a scale||Standard Deviation|Mean
2631637|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 2|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 2|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Units on a scale||Standard Deviation|Mean
2631638|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 1|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 1|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Units on a scale||Standard Deviation|Mean
2631639|NCT01843660|Primary|Pain Intensity Score Based on Numeric Rating Scale (NRS) at Hour 0.5|Pain intensity was measured using NRS (0=painless and 10=most severe pain). Score of 1-3 means mild pain; 4-6 means moderate pain and 7-10 means severe pain.|Hour 0.5|Per protocol population included all participants who completed the clinical trial according to the trial protocol.|||Units on a scale||Standard Deviation|Mean
2631640|NCT01843621|Secondary|Subject Biochemistry and Hematology Parameters Monitored for Alert Levels|"Clinical safety laboratory test were monitored for alert levels. Tests were performed by Laser scattering using Cell Dyn 3500 and Serum chemistry conducted by Kinetic method using Hitachi 717.~Normal Ranges:~Alanine Aminotransferases (ALT): LNL=0 and UNL=30 Aspartate Aminotransferases (AST): LNL=0 and UNL=40 Platelet (PLA): LNL=150000 and UNL=350000 Hematocrit (HC): LNL=35 and UNL=45 Neutrophil (NEU): LNL=1500 and UNL=8000"|Year 1 (day 0); Year 1 (day 30); Year 2|Tests were performed by Laser scattering using Cell Dyn 3500 and Serum chemistry conducted by Kinetic method using Hitachi 717. Tests included ALT, AST, PLA, HC, and NEU levels.|||U/L|||Number
2631641|NCT01843621|Secondary|Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)|"The ratio of DEN Immunoglobulin type M and G (IgM:IgG) measured at the time of booster vaccination and 30 days following was used to assess intercurrent flavivirus infection. Flavivirus infection in terms of dengue IgM and IgG and Japanese encephalitis virus (JEV) IgM and IgG is summarized.~Flavivirus immunity= ratio IgM on IgG <1.8 with either IgM or IgM >1:40~If the antibody response is detectable by isotype capture enzyme immunoassay (either the IgM or IgG component ≥40 U), its anamnestic character can be inferred from detection of a DEN IgM to IgG ratio of <1.8."|1 year, 30 Days Post Booster, 2 years||||Flavivirus immunity ratio|||Number
2631642|NCT01843621|Secondary|Presence of Dengue Viremia 10 Days After the Dengue Vaccine Dose|Nested Polymerase Chain Reaction (PCR) for DEN was conducted on day 10 after DEN booster vaccination to evaluate the presence of Dengue viremia 10 days after vaccination|10 days|Nested PCR for DEN was conducted on day 10 after DEN booster vaccination to evaluate the presence of Dengue viremia 10 days after vaccination|||Participants|||Count of Participants
2631643|NCT01843621|Secondary|Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster|Monovalent, Bivalent, Trivalent and Tetravalent response for DEN neut. antibodies 30 days post booster dose vaccine (ATP cohort for immunogenicity)|Prebooster year 1, 30 Days Post Booster, Year 2, Year 3|Monovalent, Bivalent, Trivalent and Tetravalent response for DEN neut. antibodies 30 days post booster dose vaccine (ATP cohort for immunogenicity). Immunogenicity data for one subject was not included in the ATP analysis due to an asymptomatic, sub-clinical, wild-type DEN-2 virus infection prior to DEN vaccine dose 1|||percentage of subjects||95% Confidence Interval|Number
2631644|NCT01843621|Secondary|Abnormal Findings Reported During Physical Exam 31-Days Post Vaccination|Incidence of dengue physical examination findings reported during the 31-day post-vaccination period (total vaccinated cohort)|31 days|Incidence of dengue physical examination findings reported during the 31-day post-vaccination period (total vaccinated cohort)|||Percentage of subjects||95% Confidence Interval|Number
2631645|NCT01843621|Secondary|Serious Adverse Events (SAE) Within 31 Days Post Vaccination|Occurrence of SAEs within 31 days (Day 0-30) after vaccination|31 days|Occurrence of SAEs within 31 days (Day 0-30) after vaccination|||Participants|||Count of Participants
2631646|NCT01843621|Secondary|Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination|Percentage of subjects reporting unsolicited AEs within 31 days (Day 0-30) after the DEN vaccine dose (total vaccinated cohort)|31 days|Percentage of subjects reporting unsolicited AEs within 31 days (Day 0-30) after the DEN vaccine dose (total vaccinated cohort)|||Percentage of subjects||95% Confidence Interval|Number
2631647|NCT01843621|Secondary|Solicited Local Adverse Events (AEs) Within 21 Day Follow-up|Incidence of solicited local symptoms reported during the 21-day post-vaccination (total vaccination cohort).|21 days|Incidence of solicited local symptoms reported during the 21-day post-vaccination (total vaccination cohort).|||Adverse events|||Number
2632014|NCT01838863|Post-Hoc|Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG) angle in degrees.|after injury and prior to hospital arrival, at about 15 minutes after injury||||degrees||Inter-Quartile Range|Median
2631648|NCT01843621|Primary|Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)|Neutralizing antibodies as measured by plaque reduction neutralization test (geometric mean titers [GMTs]) to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points.|Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3||||GMTs||95% Confidence Interval|Mean
2631649|NCT01843621|Primary|Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)|Neutralizing antibodies as measured by plaque reduction neutralization test (seropositivity rates to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points.|Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3|Immunogenicity data for one subject was not included in the ATP analysis due to an asymptomatic, sub-clinical, wild-type DEN-2 virus infection prior to DEN vaccine dose 1|||% of subjects||95% Confidence Interval|Mean
2631650|NCT01843465|Primary|Real-time Documentation of Pulmonary Vein Disconnection|"Possibility of real-time documentation of the pulmonary vein during cryoballoon ablation, through the use of the Achieve catheter. This will be codified as yes or no, and in case of an affirmative answer Final results will be expressed as a % of the total pulmonary veins where disconnection was documented in real-time and the time of maneuver of the Achieve catheter that was necessary i.e. standard position (type 1); withdrawal position (type 2) or need of pacing (type 3). A pulmonary vein where no real-time documentation is possible, will be named as a type 4."|atrial fibrillation cryoablation procedure|According to the different pulmonary vein anatomies in the study sample, 128 pulmonary veins were assessed.|||number of PVs disconnected in realtime|Participants||Number
2631651|NCT01843374|Secondary|Number of Participants With Positive Anti-drug Antibodies|The immunogenicity titer is reported for samples confirmed positive for the presence of anti tremelimumab antibodies.|Week 5|Safety population|||Participants|Participants||Number
2631652|NCT01843374|Secondary|Number of Participants Reporting Any Serious Adverse Events||Day 1 to 90 days post dose|Safety population|||Participants|Participants||Number
2631653|NCT01843374|Secondary|Number of Participants Reporting Any Adverse Event|Any untoward medical occurrence in a patient or clinical investigation participants administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.|Day 1- 90 days post dose|Safety population|||Participants|Participants||Number
2631654|NCT01843374|Secondary|Durable Disease Control Rate by Treatment Arm|Durable disease control rate (DDCR) is defined as the percentage of participants with best response of complete response (CR), partial response (PR), or stable disease (SD) of ≥ 6 months duration|Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.|ITT population|||Percentage|Participants|95% Confidence Interval|Number
2631655|NCT01843374|Secondary|Disease Control Rate by Treatment Arm|Disease control rate (DCR) is defined as the proportion of participants with best response of complete response (CR), partial response (PR), or stable disease (SD) of ≥ 12 weeks duration|Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.|ITT population|||Percentage|Participants|95% Confidence Interval|Number
2631656|NCT01843374|Secondary|Duration of Response by Treatment Arm|Duration of response will be defined as the duration from the first documentation of complete response (CR), partial response (PR) to the first documented disease progression.|Duration of response from the first documentation of objcetive response (confirmed CR or PR) to the first documented disease progression, assessed up to 14 weeks after the initial response.|ITT|||Months|Participants|Full Range|Median
2631657|NCT01843374|Secondary|Overall Response Rate by Treatment Arm|Overall response rate is defined as the proportion of participants with confirmed CR or PR per the modified Response Evaluation Criteria in Solid Tumours (RECIST) for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma and assessed by computed tomography (CT) or magnetic resonance imaging (MRI). Complete Response (CR) corresponds to disappearance of all target lesions, and Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR.|Time from randomization to best response to treatment, assessed up to 3 years.|ITT population|||Percentage|Participants|95% Confidence Interval|Number
2631658|NCT01843374|Secondary|Progression-free Survival by Treatment Arm|Progression-free survival will be measured from randomization to the first documentation of disease progression or death due to any cause, whichever occurs first. Progression is defined using the modified Response Evaluation Criteria in Solid Tumours (RECIST) for pleural mesothelioma or RECIST v1.1 for peritoneal mesothelioma and assessed by computed tomography (CT) or magnetic resonance imaging (MRI), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Time from randomization to disease progression or death, whichever occurs first, assessed up to 3 years.|ITT population|||Months|Participants|95% Confidence Interval|Median
2631659|NCT01843374|Secondary|OS Rate at 18 Months by Treatment Arm|The percentage of patients still alive at 18 months|18 months|ITT population|||Percentage of Participants|Participants|95% Confidence Interval|Number
2631660|NCT01843374|Primary|Overall Survival (OS)|Overall survival (OS) by treatment arm|3 years.|ITT population|||Number of Participants|Participants||Number
2631661|NCT01843348|Secondary|Duration of Wound Healing|A wound will be considered healed if all the suture material and staples are removed and the wound is intact. Number of participants is based on all patients of the respective treatment group in the safety set, excluding patients with no answer (unknown).|Post transplant until individual reporting||||days||Standard Deviation|Mean
2631662|NCT01843348|Secondary|Percent of Participants With Wound Healing Complications During Study|Information collected to report wound healing process which included percentage of participants with complications, fluid collections detected and occurrence of lymphoceles|Post transplant until individual reporting||||Percent of participants|||Number
2631663|NCT01843348|Secondary|Percent of Participants With Viral Infections|Viral infections for BKV Virus Humane Polyomavirus 1 and Cytomegalovirus|Post transplant to month 12|Safety set|||Percent of participants|||Number
2631664|NCT01843348|Secondary|Percent of Participants With Delayed Graft Function by Day|Delayed graft function (DGF) was defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day.|Post transplant up to day 7|Full analysis set|||Percent of participants|||Number
2667677|NCT01513122|Secondary|Mean Triglycerides Changes From Baseline to 48 Weeks||48 weeks||||mmol/L||95% Confidence Interval|Mean
2631665|NCT01843348|Secondary|Percent of Participants With Delayed Graft Function and Slow Graft Function|Delayed graft function (DGF) was defined as the need for dialysis within the first 7 days post-transplantation, excluding the first post-transplantation day. Slow graft function (SGF) was defined as a serum creatinine >3.0 mg/dL at Day 5 post-transplantation. Full analysis set|Post transplant to month 12|Full analysis set|||Percent of participants|||Number
2631666|NCT01843348|Secondary|Percentage of Participants With Treatment Failure Endpoints at Month 12|Treatment failure endpoints: biopsy proven acute rejection (BPAR) defined as a rejection which was acute and proven by biopsy, graft loss (GL) defined as: allograft was presumed to be lost on the day the patient starts dialysis and not able to be removed from dialysis or death. Patients who prematurely discontinued the study: if the patient did not suffer from an event before discontinuation and reason was not related to efficacy, the patient was assessed as having had no event, otherwise the patient was assessed as having had an event. Full analysis set (FAS)|Month 12 post transplant||||Percentage of participants|||Number
2631667|NCT01843348|Secondary|Glomular Filtration Rate (GFR) Via Modification of Diet in Renal Disease (MDRD) Method at Month 12 Post Transplant|Modification of Diet in Renal Disease (MDRD) = For men: GFR = 170 x (serum creatinine -0,999) x (age-0,176) x (urea nitrogen -0,17) x (albumin0,318) For women: GFR = 170 x (serum creatinine -0,999) x (age-0,176) x (urea nitrogen -0,17) x albumin0,318) x 0.762 with urea nitrogen = urea / 2.144. last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|Month 12 post transplant|Full analysis set|||mL/min per 1.73m²||95% Confidence Interval|Least Squares Mean
2631668|NCT01843348|Secondary|Glomular Filtration Rate (GFR) mL/Min Via Cockcroft- Gault Method at Month 12 Post Transplant|Cockcroft-Gault formula: For men: GFR= ((140-age) × body weight in kg)∕(72 x serum creatinine in mg∕dl)For women: GFR= (0.85×(140-age) × body weight in kg)∕(72 x serum creatinine in mg/dl), ), last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|Month 12 post transplant|Full analysis set|||mL/min per 1.73m²||95% Confidence Interval|Least Squares Mean
2631669|NCT01843348|Secondary|Glomular Filtration Rate (GFR) Via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Method at Month 12 Post Transplant|Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method = GFR=141 x min(Scr/κ, 1)α x max(Scr/κ, 1)1.209 x 0.993Age x 1.018 [if female] x 1.159 [if black] where Scr is serum creatinine, κ is 0.7 for females and 0.9 for males, α is 0.329 for females and 0.411 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1. last observation carried forward (LOCF) was used for imputation of missing values, ANCOVA model|Month 12 post transplant|Full analysis set|||mL/min per 1.73m²||95% Confidence Interval|Least Squares Mean
2631670|NCT01843348|Secondary|Percentage of Participants With Composite Treatment Failure Endpoints - Difference Between Groups at Month 12|Combined endpoint included: biopsy proven acute rejection (BPAR) defined as a rejection which was acute and proven by biopsy, graft loss (GL) defined as: allograft was presumed to be lost on the day the patient starts dialysis and not able to be removed from dialysis or death. Patients who prematurely discontinued the study: if the patient did not suffer from an event before discontinuation and reason was not related to efficacy, the patient was assessed as having had no event, otherwise the patient was assessed as having had an event. Full analysis set (FAS)|Month 12 post transplant|Full analysis set includes all participants who received at least one dose of study drug.|||Percentage of participants|||Number
2631671|NCT01843348|Primary|Glomular Filtration Rate (GFR) mL/Min Via Nankivell Method at Month 12 - Standard Regimen vs Certican Regimens|"To demonstrate non-inferiority in renal function assessed by glomerular filtration rate (Nankivell formula) in at least one of the Certican® treatment regimens compared to the standard regimen group at month 12 post-transplantation in renal transplant patients. Nankivell formula:~GFR = 6.7/Scr + BW/4 - Surea/2 - 100/(height)² + C where Scr is the serum creatinine concentration expressed in mmol/L, BW the body weight in kg, Surea the serum urea in mmol/L, height in m, and the constant C is 35 for male and 25 for female patients. The eGFR is expressed in mL/min per 1.73m². If a patient was on dialysis at the time of urea or creatinine assessment, the eGFR was set to 0. Analysis set = per protocol set"|One year post transplant|Protocol analysis set comprised of participants who received at least one dose of study drug without major protocol deviaitons|||mL/min per 1.73m²||Standard Deviation|Mean
2631672|NCT01843205|Secondary|Peak Temperature|Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||degrees Fahrenheit||Standard Error|Mean
2631673|NCT01843205|Secondary|Peak Heart Rate|Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||beats per minute||Standard Error|Mean
2631674|NCT01843205|Secondary|Peak Systolic Blood Pressure|Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||mm Hg||Standard Error|Mean
2631675|NCT01843205|Secondary|Peak Diastolic Blood Pressure|Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions.|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||mm Hg||Standard Error|Mean
2631676|NCT01843205|Secondary|"Peak Ratings of Talkative/Friendly on the Visual Analog Scale"|"Subjects rated their feelings of Talkative/Friendly on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631677|NCT01843205|Secondary|"Peak Ratings of Willing to Take Again on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Take Again on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631678|NCT01843205|Secondary|"Peak Ratings of Stimulated on the Visual Analog Scale"|"Subjects rated their feelings of Stimulated on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631679|NCT01843205|Secondary|"Peak Ratings of Sluggish/Fatigued/Lazy on the Visual Analog Scale"|"Subjects rated their feelings of Sluggish/Fatigued/Lazy on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631680|NCT01843205|Secondary|"Peak Ratings of Shaky/Jittery on the Visual Analog Scale"|"Subjects rated their feelings of Shaky/Jittery on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631681|NCT01843205|Secondary|"Peak Ratings of Rush on the Visual Analog Scale"|"Subjects rated their feelings of Rush on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631682|NCT01843205|Secondary|"Peak Ratings of Restless on the Visual Analog Scale"|"Subjects rated their feelings of Restless on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631683|NCT01843205|Secondary|"Peak Ratings of Performance Improved on the Visual Analog Scale"|"Subjects rated their feelings of Performance Improved on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631684|NCT01843205|Secondary|"Peak Ratings of Performance Impaired on the Visual Analog Scale"|"Subjects rated their feelings of Performance Impaired on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631685|NCT01843205|Secondary|"Peak Ratings of Willing to Pay For on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Pay For on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631686|NCT01843205|Secondary|"Peak Ratings of Nervous/Anxious on the Visual Analog Scale"|"Subjects rated their feelings of Nervous/Anxious on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631687|NCT01843205|Secondary|"Peak Ratings of Nauseous on the Visual Analog Scale"|"Subjects rated their feelings of Nauseous on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631699|NCT01843192|Secondary|Number of Subjects With 1 Chest Tube Placed|All subjects had either 1 or 2 chest tubes placed during surgery. Results presented are for the percentage of subjects with 1 chest tube placed.|During surgery|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||percentage of participants|||Number
2631688|NCT01843205|Secondary|"Peak Ratings of Like Drug on the Visual Analog Scale"|"Subjects rated their feelings of Like Drug on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631689|NCT01843205|Secondary|"Peak Ratings of Irregular/Racing Heartbeat on the Visual Analog Scale"|"Subjects rated their feelings of Irregular/Racing Heartbeat on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631690|NCT01843205|Secondary|"Peak Ratings of High on the Visual Analog Scale"|"Subjects rated their feelings of High on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631691|NCT01843205|Secondary|"Peak Ratings of Good Effects on the Visual Analog Scale"|"Subjects rated their feelings of Good Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631692|NCT01843205|Secondary|"Peak Ratings of Euphoric on the Visual Analog Scale"|"Subjects rated their feelings of Euphoric on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631693|NCT01843205|Secondary|"Peak Ratings of Bad Effects on the Visual Analog Scale"|"Subjects rated their feelings of Bad Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631694|NCT01843205|Secondary|"Peak Ratings of Any Effect on the Visual Analog Scale"|"Subjects rated their feelings of Any Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631695|NCT01843205|Secondary|"Peak Ratings of Active, Alert, Energetic on the Visual Analog Scale"|"Subjects rated their feelings of Active, Alert, Energetic on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631696|NCT01843205|Secondary|Peak Score on Stimulant Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Stimulant Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 stimulant items was summed to yield the Stimulant Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both bupsirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631697|NCT01843205|Secondary|Peak Score on Sedative Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Sedative Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Sedative Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each methamphetamine dose under both bupsirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 2 hours after sampling each methamphetamine dose under both buspirone and placebo maintenance conditions.||||units on a scale||Standard Error|Mean
2631698|NCT01843205|Primary|Number of Methamphetamine Doses Self-Administered|The reinforcing effects of methamphetamine will be determined during placebo and buspirone treatment using a modified progressive ratio procedure in which subjects are offered the opportunity to earn previously sampled doses of methamphetamine. Each ratio completed on the task will earn 1/10th of the sampled dose.|One test per methamphetamine dose level per intervention for each participant over his/her approximate 25 day inpatient admission||||Number of Methamphetamine Doses||Standard Error|Mean
2631750|NCT01842633|Secondary|Rate of Rescue Medication|Number of participants that took rescue medication over the total number of participants for a given treatment group|4 hours|ITT population defined as all participants who received treatment, who took rescue medication and who had at least one post-baseline efficacy assessment.|||number of participants|||Number
2631700|NCT01843192|Secondary|Occurrence of Intra-operative Leak Test|This outcome was scored as Yes or No based on whether a leak was detected during an intra-operative leak test when it was performed. Not all subjects had an intra-operative leak test performed, as it was not standard of care at all participating institutions, and so results are only presented for those subjects in whom an intra-operative test was performed.|During surgery|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure. This analysis was further restricted to those subjects in whom an intra-operative leak test was actually performed, as it was not standard of care at all participating institutions.|||participants|||Number
2631701|NCT01843192|Secondary|Operative Time|Defined as the duration in hours from the first skin incision to the closure of the last incision|Day of surgery|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||hours||Standard Deviation|Mean
2631702|NCT01843192|Secondary|Time to Chest Tube Removal|Defined as the number of days from date of surgery to removal of the last chest tube inserted during the surgical procedure.|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||days||Standard Deviation|Mean
2631703|NCT01843192|Secondary|Volume of Estimated Intra-operative Blood Loss||Blood loss intra-op and up to 5 days post-op|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||milliliters||Standard Deviation|Mean
2631704|NCT01843192|Secondary|Length of Stay (LOS)|Determined as the length of time in days from hospital admission to initial hospital discharge|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||days||Standard Deviation|Mean
2631705|NCT01843192|Primary|Occurrence of Prolonged Air Leaks|Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||percentage of participants||95% Confidence Interval|Number
2631706|NCT01843192|Primary|Occurrence of Postoperative Air Leaks|Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds) as described by Certfolio et al. 2001. Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing). Leaks were scored using the air-leak meter that comes as part of a pleura vac system from 1 to 7, with 7 being the highest (most chambers).|Post-operative period through hospital discharge and follow-up at Day 30|All subjects who consented to the study, had surgery for wedge resection, lobectomy, or wedge resection with lobectomy and were not converted to an open procedure|||percentage of participants||95% Confidence Interval|Number
2631707|NCT01843062|Secondary|Clinical Remission Rate (Expressed as Percentage of Patients in Clinical Remission) at 18 Months Post-RAI Treatment; Subgroup Analysis BRAF/NRAS Mutation Positive|"Patients were defined to be in clinical remission if all of the following criteria were demonstrated:~Serum Tg levels <1 ng/mL during rhTSH stimulation, in the absence of interfering Tg antibodies, as assessed by standardised central laboratory analysis.~No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review.~No evidence of thyroid cancer on diagnostic WBS, as assessed by blinded independent central review.~No histopathological evidence of thyroid cancer on FNA/biopsy when performed to clarify equivocal ultrasound findings, as assessed by investigator site review.~No further thyroid cancer therapy was administered in the first 18 months following the initial RAI treatment."|At 18 months post-RAI treatment|The BRAF/NRAS mutation positive analysis set included only those patients from the ITT population whose tumour samples were mutation positive for the oncogenes BRAF or NRAS.|||Percentage of participants|||Number
2631708|NCT01843062|Secondary|Clinical Remission Rate (Expressed as Percentage of Patients in Clinical Remission) at 18 Months Post-RAI Treatment; ITT Analysis Set|"Patients were defined to be in clinical remission if all of the following criteria were demonstrated:~Serum Tg levels <1 ng/mL during rhTSH stimulation, in the absence of interfering Tg antibodies, as assessed by standardised central laboratory analysis.~No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review.~No evidence of thyroid cancer on diagnostic whole body scan (WBS), as assessed by blinded independent central review.~No histopathological evidence of thyroid cancer on FNA/biopsy when performed to clarify equivocal ultrasound findings, as assessed by investigator site review.~No further thyroid cancer therapy was administered in the first 18 months following the initial RAI treatment."|At 18 months post-RAI treatment|The ITT analysis set included all randomised patients. Patients who were randomised but did not subsequently go on to receive selumetinib/placebo were included in the ITT analysis set.|||Percentage of participants|||Number
2631709|NCT01843062|Secondary|Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; Subgroup Analysis BRAF/NRAS Mutation Positive|"Patients were defined to be in complete remission if all of the following criteria were demonstrated:~Serum Tg levels <1 ng/mL during rhTSH stimulation, in the absence of interfering Tg antibodies, as assessed by standardised central laboratory analysis.~No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review.~No confirmed radiological evidence of thyroid cancer, as assessed by blinded independent central review.~No histopathological evidence of thyroid cancer FNA/biopsy when performed, as assessed by investigator site review.~No further thyroid cancer therapy was administered in the first 18 months following the initial RAI treatment."|At 18 months post-RAI treatment|The BRAF/NRAS mutation positive analysis set included only those patients from the ITT population whose tumour samples were mutation positive for the oncogenes BRAF or NRAS.|||Percentage of participants|||Number
2637469|NCT01781975|Secondary|Number of Severe Hypoglycemic Events|Major hypoglycemic events occurring from randomization at weeks 0, 52 and 104.|Visit 0 (Week 0), Visit 9 (Week 52), and Visit 13 (Week 104)||||events|||Number
2631710|NCT01843062|Primary|Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; ITT Analysis Set|"Patients were defined to be in complete remission if all of the following criteria were demonstrated:~Serum thyroglobulin (Tg) levels <1 nanograms / millilitre (ng/mL) during rhTSH stimulation, in the absence of interfering Tg antibodies, as assessed by standardised central laboratory analysis.~No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review.~No confirmed radiological evidence of thyroid cancer, as assessed by blinded independent central review.~No histopathological evidence of thyroid cancer on fine needle aspiration (FNA)/biopsy when performed, as assessed by investigator site review.~No further thyroid cancer therapy was administered in the first 18 months following the initial RAI treatment."|At 18 months post-RAI treatment|The ITT analysis set included all randomised patients. Patients who were randomised but did not subsequently go on to receive selumetinib/placebo were included in the ITT analysis set.|||Percentage of participants|||Number
2631711|NCT01842958|Secondary|Subject Satisfaction|"Subject satisfaction will be assessed utilizing Visual Analogs Scales (VAS) for general satisfaction and pain.~General satisfaction: ranged from 0 (not satisfied) to 100 (highly satisfied) Pain: ranged from 0 (no pain) to 100 (pain)"|12 months post loading|Modified Intent-to-Treat population. Data was not available for 3 subjects in 3.3 mm implant arm and for 2 subjects in the 4.1 mm implant arm.|||units on a scale||Standard Deviation|Mean
2631712|NCT01842958|Secondary|Number of Participants With Adverse Events and Adverse Device Effects|"Adverse events were checked at each study visit at the following time points: Surgical visit, 7 days (post-op), 25 days (implant loading), 6 months post-loading and 12 months post-loading. The incidence of adverse events during the period of the study is reported here, along with the number of adverse events related to device and procedure (includes possibly related, probably related and related)."|Duration of the study from surgical visit to the 12 months post-loading visit|Safety population. One subject was randomized to the 3.3 mm implant, but received the 4.1 mm implant. This subject was analyzed according to the actual implant received for the safety population.|||Participants|||Count of Participants
2631713|NCT01842958|Secondary|Gingival Recession|"Soft tissue measurements include:~CLI = length of the implant crown from highest point of the soft tissue margin to the incisal edge IPm = distance from the top of the papilla to the incisal edge mesial of the implant crown IPd = distance from the top of the papilla to the incisal edge distal of the implant crown CLTm = length of the crown from highest point of soft tissue margin to the incisal edge of the adjacent mesial tooth CLTd = length of the crown from highest point of soft tissue margin to the incisal edge of the adjacent distal tooth~Reporting change in soft tissue measurements from 6 months post-loading (final restoration) to 12 months post-loading in millimeters."|6 months to 12 months post loading|Modified Intent-to-Treat population. Data was not available from 4 subjects in the 3.3 mm arm and 3 subjects in the 4.1 arm|||mm||Standard Deviation|Mean
2631714|NCT01842958|Secondary|Implant Survival Rate|Percentage of participants with surviving implant (a surviving implant is one that is in place at the time of follow-up)|7 days, 25 days, 6 months post loading, and 12 months post loading|modified Intent-to-Treat population|||Participants|||Count of Participants
2631715|NCT01842958|Secondary|Implant Success Rate|Percentage of participants with successful and non-successful implant (definition of implant success according to Buser et al. 1991: Absence of persistent subjective complaints, such as pain, foreign body sensation and/ or dysesthesia; Absence of a recurrent peri-implant infection with suppuration; Absence of mobility; Absence of a continuous radiolucency around the implant)|25 days, 6 months post loading, and 12 months post loading|modified Intent-to-Treat population|||Participants|||Count of Participants
2631716|NCT01842958|Secondary|Additional Mean Crestal Bone Level Changes|Additional radiographic evaluation of mesial and distal crestal bone level changes between implant placement and at 25 days post post implant placement, 6 months post loading, and 12 months post loading|Baseline (implant placement), 25 days post implant placement, 6 months post loading, and 12 months post loading|modified Intent-to-Treat population|||mm||Standard Deviation|Mean
2631717|NCT01842958|Primary|Mean Crestal Bone Level Change|Mean crestal bone level change between implant placement and 12 months post loading as determined by radiographic measurement of mesial and distal bone levels following placement of a Straumann Bone Level implant with 3.3 mm diameter versus a Straumann Bone Level implant with 4.1 mm diameter in the anterior or pre-molar region of the mandible or maxilla.|Baseline (implant placement) and 12 months post loading|modified Intent-to-Treat population|||mm||Standard Deviation|Mean
2631718|NCT01842906|Secondary|Nocturnal Awakenings|Number of nocturnal desaturations will be measured by Watch-PAT200, a wristwatch type continuous sleep cycle and pulse oximetry analyzer. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.|approximately 10 hours||||Number of events||Inter-Quartile Range|Median
2631719|NCT01842906|Secondary|Acute Mountain Sickness Severity|Severity of acute mountain sickness will be evaluated by the Lake Louise Criteria (0-15 point scale) with higher scores representing more severe symptoms. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.|approximately 10 hours|Severity|||unit on a scale||Inter-Quartile Range|Median
2631720|NCT01842906|Secondary|Number of Nocturnal Desaturations|Number of nocturnal desaturations will be measured by Watch-PAT200, a wristwatch type continuous sleep cycle and pulse oximetry analyzer. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.|Approximately 10 hours||||Number of events||Standard Deviation|Mean
2631721|NCT01842906|Primary|Incidence of Acute Mountain Sickness|Acute mountain sickness will be measured by Lake Louise Criteria and diagnosed as LLC > or = to 3 with presence of a headache. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.|Approximately 10 hours||||Participants|||Count of Participants
2631722|NCT01842841|Secondary|Change From Baseline in Chemokine [C-C Motif] Ligand 18 (CCL18) Levels at Week 101|Plasma CCL18 concentrations were measured using a time-resolved fluorescence assay. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 101|Safety population|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2632015|NCT01838863|Post-Hoc|Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) activated clotting time (ACT) in seconds.|post-intervention and upon ED arrival||||second||Inter-Quartile Range|Median
2631723|NCT01842841|Secondary|Number of Participants With Change From Baseline in Neurological Status at Week 103|Neurological status was considered normal or abnormal based on investigator's discretion. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Safety population. Number of participants analyzed signifies participants evaluable for this outcome.|||participants|||Number
2631724|NCT01842841|Secondary|Change From Baseline in Plasma Chitotriosidase Levels at Week 101|Plasma chitotriosidase activity levels were measured using an enzymatic assay with 4-methylumbelliferyl-deoxychitobiose as a substrate. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 101|Safety population. Number of participants analyzed signifies participants who were not deficient at baseline in chitotriosidase activity or who did not have a 24 base pair duplication in either copy of the chitotriosidase gene.|||nanomole/milliliter/hour (nmol/mL/h)||Standard Deviation|Mean
2631725|NCT01842841|Secondary|Change From Baseline in Skeletal Age at Week 103: Z-Score|Skeletal age was measured via radiography (X-ray) of the left hand and wrist by the method of Greulich and Pyle. The Z-score, or Standard Deviation Score, is a measure of number of SDs above or below the average BMD of a healthy participant of the same age and gender. Statistical analysis plan only required summarization if >50% of participants had evaluable data. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Data was not reported as there was <50% of participants had evaluable data.||||||
2631726|NCT01842841|Secondary|Change From Baseline in Growth Velocity at Week 101 : Height Z-Score|The Z-score, or Standard Deviation Score, is a measure of number of SDs above or below the average BMD of a healthy participant of the same age and gender. World Health Organization 2007 growth reference data were used for Z-score calculation. Statistical analysis plan only required summarization if >50% of participants had evaluable data. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 101|Data was not reported as there was <50% of participants had evaluable data.||||||
2631727|NCT01842841|Secondary|Change From Baseline in Bone Marrow Burden (BMB) Score at Week 103|BMB Score was measured using MRI, range from 0 (no abnormalities) to 8 points (severe disease) for the lumbar spine and from 0 (no abnormalities) to 8 points (severe disease) for the femurs. The total score was calculated as the sum of scores for femur and lumbar spine regions which ranged from 0-16 points. A higher BMB score signified more severe bone marrow involvement. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Safety population.|||units on a scale||Standard Deviation|Mean
2631728|NCT01842841|Secondary|Change From Baseline in Bone Mineral Density (BMD) at Week 103: T-Score|BMD was measured by DXA for lumbar spine and femurs. To ensure standardization and allow for comparisons of BMD, results were converted to standardized T-scores; normal values were used from databases from Hologic based on standard criteria. T-scores are the number of SDs above or below the average for a young adult at peak BMD. Statistical analysis plan only required summarization if >50% of participants had evaluable data. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Data was not reported as there were <50% of participants with evaluable data.||||||
2631729|NCT01842841|Secondary|Change From Baseline in Bone Mineral Density (BMD) at Week 103: Z Score|BMD was measured by dual energy x-ray absorptiometry (DXA) for lumbar spine and femurs. To ensure standardization and allow for comparisons of BMD, results were converted to standardized Z-scores (matched for age and gender). Z-scores express the BMD as the number of standard deviations (SDs) above or below the average BMD of a healthy participant of the same age and gender. Statistical analysis plan only required summarization if greater than (>) 50 percent (%) of participants had evaluable data. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Data was not reported as there were lesser than (<) 50% of participants with evaluable data.||||||
2631730|NCT01842841|Secondary|Change From Baseline in Spleen Volume Normalized to Body Weight at Week 103|Spleen volume was measured using MRI. Spleen volume measurements were normalized to the percentage of body weight. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Safety population|||Percentage of body weight||Standard Deviation|Mean
2631731|NCT01842841|Secondary|Change From Baseline in Liver Volume Normalized to Body Weight at Week 103|Liver volume was measured using magnetic resonance imaging (MRI). Liver volume measurements were normalized to the percentage of body weight. Week 51 of Study HGT-GCB-087 (NCT01614574) was considered as baseline for this endpoint.|Baseline, Week 103|Safety population|||Percentage of body weight||Standard Deviation|Mean
2631732|NCT01842841|Secondary|Change From Baseline in Platelet Count at Week 101|Baseline was the modified baseline platelet count, the average of the values from screening, baseline, and Week 1 Day 1 from Study HGT-GCB-087 (NCT01614574).|Baseline, Week 101|Safety population|||*10^9 platelets per liter||Standard Deviation|Mean
2631733|NCT01842841|Secondary|Change From Baseline in Hemoglobin Concentration at Week 101|Baseline was the modified baseline hemoglobin concentration, the average of the values from screening, baseline, and Week 1 Day 1 from Study HGT-GCB-087 (NCT01614574).|Baseline, Week 101|Safety population|||gram per deciliter (g/dL)||Standard Deviation|Mean
2631734|NCT01842841|Primary|Number of Participants With Positive Anti-Velaglucerase Alfa Antibodies|Serum samples were collected for all participants for determination of anti-velaglucerase alfa antibodies every 12 weeks.|From Week 65 until the end of study (Week 155)|Safety population.|||participants|||Number
2631735|NCT01842841|Primary|Number of Participants With Abnormal and Clinically Significant Laboratory Test Results|Laboratory test results were considered abnormal and clinically significant at the discretion of the investigator.|From Week 65 until the end of study (Week 155)|Safety population.|||participants|||Number
2631736|NCT01842841|Primary|Number of Participants Using Concomitant Medication||From the day of first infusion (Week 53) up to 30 days after last infusion (approximately 107 weeks)|Safety population.|||participants|||Number
2631751|NCT01842633|Secondary|Global Evaluation of Response to Treatment|Global evaluation of treatment response was measured by a score in a scale from: 0-very poor, 1-poor, 2-neutral [neither poor nor good], 3-good, or 4-very good).|4 hours|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
2638561|NCT01772576|Other Pre-specified|Sensed Amplitude|Sensed Amplitude at 3 Months Post-Implant|3 Months Post-Implant|Patients having undergone the 3 months follow-up|||mV||95% Confidence Interval|Mean
2631737|NCT01842841|Primary|Number of Participants With Drug-related Adverse Events (AEs), Infusion-related AEs, and Serious AEs (SAEs)|An AE was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered related to investigational product. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An infusion-related AE was defined as an AE that started either during or within 12 hours after the start of the infusion and that was judged as possibly or probably related to investigational product.|From the day of first infusion (Week 53) up to 30 days after last infusion (approximately 107 weeks)|Safety population.|||participants|||Number
2631738|NCT01842789|Secondary|Recovery Time|Patients to be followed for 1 to 2 months post-treatment to evaluate recovery.|1 to 2 months|All subjects followed for 1 to 2 months post treatment.|||days||Full Range|Median
2631739|NCT01842789|Primary|Number of Minutes From Visualizing the Target to Reaching the Target|To measure difference in time to target with and without the use of TAG. This is a time and motion study, with time measured at each stage of the procedure. The most important subject variable to consider was number of fibroids targeted, which influenced overall procedure time.|Intraoperative|All participants undergoing treatment with Acessa (with or without targeting animation guidance).|||Minutes per fibroid treated||Full Range|Mean
2631740|NCT01842789|Primary|Physician Feedback Regarding TAG System Use During Surgery.|"Physician preference testing is assessed by the completion of a questionnaire using a 5 point rating system ranging from strongly agree (a rating of 5) to strongly disagree (a rating of 1) regarding the use of the TAG system. The questions included are in regards to ease of targeting, ease of visualizing the target, the addition of specific features that enhance user interface and the overall set-up."|Physicians have up to 1 hour after the procedure to fill out the questionnaire|All subjects in whom TAG was used as an accessory system. This outcome measure was specific to this arm of the study only. Physicians provided feedback regarding use of the accessory system but did not provide feedback regarding the standard system without guidance. Physicians rated the system on a scale of 1 Strongly disagree to 5 Strongly agree.|||units on a scale||Standard Deviation|Mean
2631741|NCT01842646|Secondary|Number of Participants With Treatment Emergent Adverse Events|Treatment emergent adverse events occurring in equal to or more than 10% of participants.|2 years, 4 months|All participants|||Participants|||Count of Participants
2631742|NCT01842646|Secondary|Median Time to Transformation to Acute Myeloid Leukemia (AML)|To estimate the time to transformation to AML in patients with <20% blasts. In patients with less than 20% blasts, the time to transformation to AML will be defined as the date of the first dose of drug until either the percentage of bone marrow blasts or the percentage of peripheral blasts exceeds 20%, whichever is first.|Up to 2 years, 4 months|NA- The median time to AML was not reached due to insufficient number of participants with events.||||||
2631743|NCT01842646|Secondary|Median Event Free Survival|To estimate the event-free survival of patients of this population. Event-free survival will be defined as the date of the first dose of study drug until failure (disease progression) or death from any cause.|Up to 2 years, 4 months|All participants|||months||95% Confidence Interval|Median
2631744|NCT01842646|Secondary|Median Overall Survival (OS)|To estimate the overall survival of patients with refractory/relapsed myelodysplastic Syndrome (MDS) and chronic myelo-monocytic leukemia (CMML) treated with PF-0444913. Overall survival will be defined as the time period between the date of the first dose of drug until the time of death.|Up to 2 years, 4 months|All participants|||months||95% Confidence Interval|Median
2631745|NCT01842646|Primary|Overall International Working Group (IWG) 2006 Response Rate|Response recorded from the start of the treatment until disease progression/recurrence. All responses must last for at least 8 weeks. Complete Remission (CR): Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines, Persistent dysplasia will be noted, Peripheral blood: Hemoglobin ≥ 11 g/dL, Platelets ≥ 100 x 10^9/L, Neutrophils ≥ 1.0 x 10^9/L, Blasts 0% ; Partial Remission (PR): All CR criteria if abnormal before treatment, except: Bone marrow blasts decreased by ≥ 50% over pretreatment but still > 5%, Cellularity and morphology not relevant; Marrow CR or Hematological Improvement (HI): Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment Peripheral blood: if HI responses, they will be noted in addition to marrow CR. Further investigation of PF-04449913 would not be warranted if it produced an overall response rate (CR + PR + marrow CR+HI) of 10% or less (p0), and would be warranted if it produced an overall response rate of 30% or more (p1).|Up to 2 years, 4 months|All participants|||Participants|||Count of Participants
2631746|NCT01842633|Secondary|Time to the Use of Rescue Medication.|Time taken by the participants to use the rescue medication|Up to 4 hours|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment|||Minutes||Standard Deviation|Mean
2631747|NCT01842633|Secondary|Number of Pain Free Participants|Number of participants with complete relief was calculated as the number of participants who reported PRS = 4-complete relief at 1 hour and 2 hours post dose.|1 hour and 2 hour post dose|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||number of participants|||Number
2631748|NCT01842633|Secondary|Headache Relief|The participant assessed headache relief of each treated qualifying headache at 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 minutes post treatment on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). higher headache relief score indicates better outcome.|At 10 min. 15 min., 20 min., 25 min., 30 min., 40 min., 50 min., 60 min., 90 min., 120 min., 180 min., 240 min.,|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
2631749|NCT01842633|Secondary|Change From Baseline in Headache Pain Intensity|Change from baseline in headache pain intensity was calculated as the change (difference) from baseline PI with PI at each time-point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache).|At 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 min.|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
2653317|NCT01644240|Primary|AUCtau|Area under the plasma concentration time curve over the dosing interval estimated using the linear trapezoidal rule.|Day 1||||pg*hr/mL||Standard Deviation|Mean
2631752|NCT01842633|Secondary|Area Under the Time-Response Curve for Change in Headache Intensity and Headache Relief (SPRID)|SPRID was measured as sum of TOTPAR and SPID. SPID and TOTPAR were calculated as weighted sums of PID and PRS at each measurement time point, respectively. PID at each time point was calculated as difference of PI at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache). PRS was assessed on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). The range of SPRID for different time points were as follow: from-3 to 5 for SPRID at 1 hour post dose, from -6 to 10 for SPRID at 2 hours post dose, from -9 to 15 for SPRID at 3 hours post dose, and from -12 to 20 for SPRID at 4 hours post dose.|From (Baseline) 0 to 1 hour, 0 to 2 hours, 0 to 3 hours and 0 to 4 hours post dose|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
2631753|NCT01842633|Secondary|Total Pain Relief (TOTPAR)|TOTPAR was calculated as the weighted sum of pain relief scores (PRS) at each time point. PRS was assessed on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). The range for TOTPAR for different time points were as follows: from 0 to 4 for TOTPAR at 1 hour post dose, from 0 to 8 for TOTPAR at 2 hours post dose, from 0 to 12 for TOTPAR at 3 hours post dose, and from 0 to 16 for TOTPAR at 4 hours post dose.|From (Baseline) 0 to 1, from 0 to 2, from 0 to 3 and from 0 to 4 hour post dose|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
2631754|NCT01842633|Secondary|Time to Meaningful Headache Relief|Time to meaningful headache relief was assessed as time when participants reported a PRS ≥ 2.|Baseline up to 4 hours|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||min.||Full Range|Median
2631755|NCT01842633|Secondary|Number of Participants With Meaningful Pain Relief||Baseline up to 4 hours|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||number of participants|||Number
2631756|NCT01842633|Secondary|Time to Perceptible Headache Relief|Time to perceptible headache relief was assessed as the time when participants achieve pain relief scores (PRS) more than or equal to 1.|Baseline up to 4 hours|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||minutes (min.)||Full Range|Median
2631757|NCT01842633|Secondary|Number of Participants With Perceptible Pain Relief||Baseline up to 4 hours|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||number of participants|||Number
2631758|NCT01842633|Secondary|Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours|"SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 1, 2 and 3 hours post dose.~The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60 minutes for SPID at 1 hour post dose. The range of SPID at 1 hour post dose was from -3 to 1. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120 minutes for SPID at 2 hours post dose . The range of SPID at 2 hours post dose was from -6 to 2. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180 minutes for SPID at 3 hours post dose. The range of SPID at 3 hours post dose was from -9 to 3. PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache)."|From (Baseline) 0 to 1 hour, 0 to 2 hours, and 0 to 3 hours post dose|ITT population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
2631759|NCT01842633|Primary|Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours|"SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 4 hours post dose. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180, 180-240 minutes. The range of SPID at 4 hours post dose was from -12 to 4. PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache)."|Up to 4 hours post dose|Intention-to-treat (ITT) population defined as all participants who received treatment and who had at least one post-baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
2631760|NCT01842620|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of the Study Drug (Oxemet) and the Reference Drug (Glafornail) Over Period|Time to reach maximum plasma concentration is the time at which Cmax of metformin was obtained for test and reference products.|From 0 to 36 h|PKP population|||h||Full Range|Median
2631761|NCT01842620|Secondary|Terminal Plasma Half-life (t1/2) of the Study Drug (Oxemet) and the Reference Drug (Glafornail) From 0 to 36 h|Terminal phase half-life is the time required for the study drug to reduce to 50% of its concentration. t1/2 of Metformin was determined for each participant, both for Test and Reference products.|From 0 to 36 h|PKP population|||h||Full Range|Median
2631762|NCT01842620|Secondary|The Elimination Constant (Kel) of the Study Drug (Oxemet) and the Reference Drug (Glafornail) From 0 to 36 h|The elimination constant (kel) of Metformin was analyzed for each participant, both for Test and Reference products. The calculations were based on the actual sampling times recorded during the study.|From 0 to 36 h|PKP population|||Per hour||Full Range|Median
2631763|NCT01842620|Primary|Geometric Means for Maximum Plasma Concentration of the Study Drug (Oxemet) to the Reference Drug (Glafornail) From 0 to 36 h|Cmax is maximum plasma concentration of metformin. Plasma concentration-time curve of metformin from time 0 to 36 h was calculated by non-compartmental methods with WinNonlin Version 6.02. The calculations were based on the actual sampling times recorded during the study. Period wise data has been presented; however, the statistical analysis has been presented for overall period.|From 0 to 36 h|PKP population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2631787|NCT01842581|Secondary|Number of Participants Who Died Due to Any Reason||From randomization (Day 1) up to end of study (Day 186)|Safety population was the same as the ITT population that included randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2633479|NCT01824446|Primary|Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-004184|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Up to 288 hours post-dose|PAS|||hours||Full Range|Median
2631764|NCT01842620|Primary|Geometric Means for Area Under Plasma Concentration Time Curve of the Study Drug (Oxemet) to the Reference Drug (Glafornail) Between Time Zero to Infinity (Inf) Over Period|Area under plasma concentration-time curve of metformin from time 0 to inf was calculated by non-compartmental methods with WinNonlin Version 6.02. The calculations were based on the actual sampling times recorded during the study. Period wise outcome data has been presented; however, the statistical analysis has been presented for overall period.|From 0 to 36 h|PKP population included all the participants who underwent plasma PK sampling and had evaluable area under curve assay results|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2631765|NCT01842620|Primary|Geometric Means of Area Under Plasma Concentration Time Curve of the Test Drug (Oxemet) to the Reference Drug (Glafornail) From Time Zero to the Time of Last Quantifiable Concentration of 36 Hours (h)|Area under plasma concentration-time curve of metformin was quantifiable from time 0 to 36 h. The parameter was calculated by non-compartmental methods with WinNonlin Version 6.02. The calculations were based on the actual sampling times recorded during the study. Period wise outcome data has been presented; however, the statistical analysis has been presented for overall period.|From 0 to 36 hours (h)|PK parameters [PKP] population included all the participants who underwent plasma PK sampling and had evaluable area under curve assay results.|||nanogram* h/millilitre (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2631766|NCT01842607|Secondary|Number of Participants With Haematology Laboratory Parameters Outside the Normal Range at Any Time Post-baseline|Haematology laboratory parameters included basophils, basophils/leukocytes, blood erythrocytes, blood leukocytes, eosinophils, eosinophils/leukocytes, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), erythrocytes distribution width (EDW), hematocrit, hemoglobin, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils segmented (NS), neutrophils/leukocytes, platelets, reticulocytes assessed at Baseline, Week 4, Week 16, Week 28, Week 52 and follow-up visit (approx. 12 weeks post-last dose). Hematology abnormalities outside the normal range (high and low values) at any time post baseline were presented. Any time post Baseline is equal to all visits (including scheduled and unscheduled) post Baseline were considered for this visit derivation. If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed ( n=X in the category titles).|||Participants|||Number
2631767|NCT01842607|Secondary|Number of Participants With Clinical Chemistry Parameters Outside the Normal Range at Any Time Post-baseline|Clinical chemistry laboratory parameters included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatine kinase, creatinine, direct bilirubin, gamma glutamyl transferase, high density lipoprotein (HDL) cholesterol, indirect bilirubin, low density lipoprotein (LDL) cholesterol, lactate dehydrogenase, phosphate, plasma/serum protein, potassium, serum glucose, sodium, triglycerides, urea, and very low density lipoprotein (VLDL) cholesterol assessed at the indicated time points. Laboratory abnormalities outside the normal range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed ( n=X in the category titles).|||Participants|||Number
2631768|NCT01842607|Secondary|Change From Baseline in Pulse Rate Assessed at Week 52|Vital sign measurements including sitting pulse was performed at Baseline, at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and follow-up visit (approx. 12 weeks post-last dose). Vital measurements were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point.|Baseline and Week 52|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Beats per minute (BPM)||Standard Deviation|Mean
2631769|NCT01842607|Secondary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Week 52|Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were performed at Baseline, at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and follow-up visit (approx. 12 weeks post-last dose). Vital measurements were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point.|Baseline and Week 52|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2631770|NCT01842607|Secondary|Number of Participants With Maximum Change From Baseline in QTcB Interval for ECG Assessed at Any Time Post Baseline|12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). Participants with maximum change (MC) from Baseline were summarized at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||participants|||Number
2631788|NCT01842581|Secondary|Number of Participants Who Were Hospitalized Due to HE Episode|An HE-related hospitalization was defined as a hospitalization directly resulting from HE, or when HE events occurred during hospitalization. The time to first HE-related hospitalization was defined as the duration between the date of first dose of study drug and the date of first HE-related hospitalization. Number of participants who were hospitalized due to HE episode during randomization to Month 6 is presented.|From randomization (Day 1) up to Day 170|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2633521|NCT01823861|Secondary|Pregnancy||4 months|||||||
2631771|NCT01842607|Secondary|Number of Participants With Maximum Change From Baseline in QTcF Interval for ECG Assessed at Any Time Post Baseline|12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). Participants with maximum change (MC) from Baseline were summarised at any time post Baseline for the following categories <-60, >=-60 to <-30, >=-30 to <0, >=0 to <30, >=30 to <60 and >=60. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Participants|||Number
2631772|NCT01842607|Secondary|Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for ECG Assessed at Baseline, Week 28, Week 52 and at Follow-up Visit (Approx. 12 Weeks Post-last Dose)|12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Milliseconds (msec)||Standard Deviation|Mean
2631773|NCT01842607|Secondary|Number of Participants With Electrocardiogram (ECG) Findings at Any Time Post Baseline|12-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. ECG was performed at Baseline, Week 28, Week 52 and at the end of follow-up period (approx. 12 weeks post-last dose). ECG findings were summarised at any time post Baseline for participants as normal, abnormal-not clinically significant(A-NCS) and abnormal-clinically significant (A-CS).|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, only participants with ECG results post-baseline were analyzed|||Participants|||Number
2631774|NCT01842607|Secondary|Number of Participants With Systemic (i.e., Allergic/IgE-mediated and Non-allergic) and Local Site Reactions|Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Hypersensitivity reactions (i.e., allergic or IgE-mediated reactions) were monitored using the diagnostic criteria for anaphylaxis as outlined by the 2006 Joint NIAID/FAAN Second Symposium on Anaphylaxis. Information was also collected to assess localized site reactions as determined by the investigator. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population|||Participants|||Number
2631775|NCT01842607|Secondary|Number of Participants Hospitalized Due to Exacerbations and Adverse Events|AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Exacerbation is defined as worsening of asthma which requires use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population|||Participants|||Number
2631776|NCT01842607|Secondary|Number of Participants Withdrawn Due to Lack of Efficacy and Adverse Events From the Study|AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population.|||Participants|||Number
2631777|NCT01842607|Secondary|Mean Change From Baseline in Clinic Pre-bronchodilator FEV1 Over the 52-week Treatment Period|FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at Baseline, Week 16, Week 28 and Week 52. Spirometry was performed within ± 1 hour of the Baseline assessment. The change from Baseline is defined as the difference between the value of the end point at the time point of interest and Baseline value.|From Baseline and up to Week 52|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Milliliters (mL)||Standard Deviation|Mean
2631778|NCT01842607|Secondary|Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score|The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma control. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze). The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 5 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population, Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Score on scale||Standard Deviation|Mean
2631806|NCT01841931|Primary|Opiate Withdrawal|Goal that patients will have NO withdrawal symptoms by the completion of their 3-day buprenorphine induction, and will remain withdrawal-free for the entire study duration.Assessed using Clinical Opiate Withdrawal Scale (COWS).|6 months|||||||
2631779|NCT01842607|Secondary|Annualized Rate of Exacerbations Per Year|Exacerbations are defined as the worsening of asthma which requires use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit. Analysis of the number of exacerbations was performed using a negative binomial model with covariates of region, exacerbations in the year prior to the start of MEA115588 or MEA115575 (as an ordinal variable) and baseline percent (%) predicted forced expiratory volume in 1 second (FEV1), and with logarithm of time on treatment as an offset variable.|Baseline up to Exit Visit (approx. 52 weeks) or if Early Withdrawal 4 weeks post last dose|AT Population|||Exacerbations per year||95% Confidence Interval|Mean
2631780|NCT01842607|Secondary|Number of Participants With Positive Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies (NAb) at the Indicated Time Points|Blood samples were collected for the determination of anti-mepolizumab antibodies (ADA) just prior to administration of mepolizumab at indicated time points. Samples that tested positive for anti-mepolizumab antibodies were further tested for the presence of NAb. Participants who switched from the 250 mg vial to the 100 mg vial required one immunogenicity sample prior to the first dose from the 100 mg vial and one sample prior to the second dose from the 100 mg vial at the next visit. The highest value post-baseline visit are based on each participant's highest post-baseline titer. NAb assay result was only presented for participants with positive ADA assay. Highest value post-baseline would be positive for a participant who had both negative and positive post-baseline results.|From Baseline visit until the follow-up visit (approx. week 60 [12 weeks post-last dose])|AT Population. Only those participants available at the indicated timepoints were analyzed (represented by n=X in the category titles).|||Participants|||Number
2631781|NCT01842607|Primary|Number of Participants With Adverse Events (AEs) Including Both Systemic (i.e. Allergic/Immunoglobulin (Ig)E-mediated and Non-allergic) and Local Site Reactions|AEs were collected from the Baseline visit until the follow-up visit (approx. 12 weeks post-last dose). Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab.|From Baseline visit until the follow-up visit (approximately [approx.] week 60 [12 weeks post-last dose])|As Treated (AT) Population: all participants who received at least one dose of open label mepolizumab.|||Participants|||Number
2631782|NCT01842594|Secondary|The Toxicity|Number of Participants with Adverse Events. Toxicities parameters are according to the Nation Cancer Institute Common Terminology Criteria for Adverse Event, version 3.0.|2 Weeks||||participants|||Number
2631783|NCT01842594|Primary|The Maximum Standardized Uptake Values (SUVmax) Change on PET/CT Scan|A baseline whole-body [18F]-fluorodeoxyglucose(FDG) PET was performed before therapy initiation. Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks. A second [18F]-FDG PET was performed after treatment completion. SUVs were calculated for all lesions. Regions of interest (ROI) were contoured to represent tumors (>2 cm) and organs (lungs, spleen, and liver) on all transaxial and coronal slices. ROIs were normalized for injection dose and body weight, and the maximum voxel value was recorded for each region or organ. The highest SUV measured with increased uptake was considered the SUVmax. Correlative diagnostic CT examinations were used for accurate localization of the lesions. The most intense uptake at baseline was identified as the index lesion and evaluated for treatment response.|2 Weeks||||percentage of the SUVmax Change|Participants|95% Confidence Interval|Mean
2631784|NCT01842581|Other Pre-specified|Change From Baseline in Critical Flicker Frequency (CFF) at Day 170|The critical flicker frequency (CFF), a validated assessment of neurological function was assessed using a specialized CFF instrument. The CFF is the frequency at which the participant observes a constant light transition to a flickering light and was measured in Hertz. The CFF was measured on a continuous scale and was the mean of 8 separate fusion-to-flicker transition tests performed in rapid succession. Increases in CFF results represent improvement in neurological function in participants with HE.|Baseline, Day 170|ITT population included all randomized participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoint.|||hertz||Standard Deviation|Mean
2631785|NCT01842581|Other Pre-specified|Change From Baseline in Total Chronic Liver Disease Questionnaire (CLDQ) Score at Day 170|CLDQ was used to measure health-related quality of life. CLDQ includes 29 items in the following 6 domains: abdominal symptoms (3 items), fatigue (5 items), systemic symptoms (5 items), activity (3 items), emotional function (8 items), and worry (5 items). All items were measured on a 7-point Likert scale, ranging from 0 to 6 with higher values indicating better quality of life. Each domain score of CLDQ was calculated as the mean of the responses of items in that domain. Overall CLDQ score was obtained by adding scores for each item and dividing by the total number of items. Overall CLDQ score ranged from 0 (most impairment) to 6 (least impairment) with higher scores indicating better quality of life. If at least half of the items were non-missing for a domain, mean values of the non-missing items for that domain were used as imputed values for missing values. If more than half of the items in a domain were missing, no values were imputed and domain score was considered as missing.|Baseline, Day 170|ITT population included all randomized participants who received at least 1 dose of study drug. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
2631786|NCT01842581|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAE was defined as an AE that occurred from first dose of study drug until last dose of study drug plus 5 days (for non-fatal AEs) or plus 30 days (for fatal AEs).A summary of non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|From randomization (Day 1) up to end of study (Day 186)|Safety population was the same as the ITT population that included randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2631789|NCT01842581|Primary|Number of Participants Reporting a First Breakthrough HE Episode|A breakthrough HE episode was defined as an increase of the Conn score to Grade greater than or equal to (≥) 2 (ie, 0 or 1 to ≥ 2). Conn score is widely used as a measure of mental state in HE. The scale used in Conn scoring system include: Grade 0=No personality or behavioral abnormality; Grade 1=Trivial lack of awareness, euphoria, or anxiety; shortened attention span, impairment of addition or subtraction; Grade 2=Lethargy, disorientation for time, obvious personality change, inappropriate behaviour; Grade 3=Somnolence to semi-stupor, responsive to stimuli, confused, gross disorientation, bizarre behaviour; Grade 4=Coma, unable to test mental state. The time to the first breakthrough HE episode was defined as the duration between the date of first dose of study drug and the date of first breakthrough HE episode. Number of participants reporting a first breakthrough HE episode during randomization to Month 6 is presented.|From randomization (Day 1) up to Day 170|ITT population included all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2631790|NCT01842464|Primary|Number of Participants Involving in Complications: Operative Damage and Bleeding, Post Operative Infection and Mesh Exposure|Number of participants involving in complications: operative damage and bleeding, post operative infection and mesh exposure.|one year|occurrence and severity of complication is recorded|||participants|||Number
2631791|NCT01842464|Primary|Efficacy of Sacro-Spinous Ligaments Anterior Apical Anchoring|Level of support with the Sacro-Spinous Ligaments Anterior Apical Anchoring higher than 4 centimeters above vaginal opening.|one year||||participants|||Number
2631792|NCT01842464|Primary|The Change With Distance Between the Vaginal Apex and the Introitus|The change with distance measured by centimeters, between the vaginal apex and the introitus|One year||||centimeters||Full Range|Mean
2631793|NCT01842438|Secondary|SCORE15 (Systemic Core Outcome Measure)|SCORE15 is an index of Family Function and Change, with 15 items. The potential range of scores is 15 to 75, with a lower score indicating higher family functioning. Total scores are reported in the data below.|Basline (T0), immediate post-intervention (T1) and 6 Months (T2)|Data received at each time-point was T0: intervention 42, control: 43; T1: intervention 36, control 36; T2 (as above) intervention 28, control 32|||units on a scale||Standard Deviation|Mean
2631794|NCT01842438|Secondary|HADS (Hospital Anxiety and Depression Scale)|"The HADS has two scales: one anxiety and one depression. It is validated with population norms. Results are presented for T2 (6 month follow-up) and split by Patient, Partner and again by Intervention, Control.~Responses are scored on a scale of 0-3 (3 indicates higher symptom frequencies. Scores for each subscale (anxiety and depression) range from 0 to 21 with scores categorized as follows: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21. Scores for the entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress."|Basline (T0), immediate post-intervention (T1) and 6 Months (T2)|Data received at each time-point was T0: intervention, T1: immediately after intervention; T2 6months post intervention.|||units on a scale||Standard Deviation|Mean
2631795|NCT01842438|Primary|EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale|EPIC is a quality of life tool used in prostate cancer studies, focused on physical and sexual outcomes. It is validated with population norms. We used the sexual bother sub-scale as the primary outcome measure; score range 0-400. A higher score indicates better function/better outcome.|Basline (T0), immediate post-intervention (T1) and 6 Months (T2)|Primary outcome was at T1, sample size at T1, n=21 intervention, n=22 control. Sample size at T2, n=13 intervention, n=14 control At T1 (immediate follow-up) 3 intervention patients had withdrawn and 4 control patients had withdrawn. The scale was completed only by patients (all of whom were men, by as study focused on prostate cancer).|||units on a scale||Standard Deviation|Mean
2631796|NCT01842334|Primary|Change From Baseline in Cigarette Smoking in Treatment Seeking Nicotine Dependent Outpatients|Cigarette smoking at 10 weeks as measured by carbon monoxide levels and self-report measurements.|During Week 10|Only the 5 completers of this study who made it to week 10 could have this measure analyzed.|||Cigarettes/day||Standard Deviation|Mean
2631797|NCT01841970|Secondary|Mean Pain Score Based on the Visual Analog Pain Scale|Mean pain score based on the Visual Analog pain scale. Patient reported pain on 10 point scale where 0 =No Pain and > 0 = Pain with 10 being the worst.|Post treatment at Month 1, Month 3, Month 6|At Month 1, 3 and 6 the number of participants include patients followed through that time period. The remaining patients were lost to follow up.|||units on a scale||Standard Deviation|Mean
2631798|NCT01841970|Secondary|Pain Recorded Yes or No on Visual Analog Scale (VAS)|Patient reported pain on 10 point scale where 0 =No Pain and > 0 = Pain with 10 being the worst.|Post treatment at Month 1, Month 3, Month 6|At Month 1, 3 and 6 the number of participants include patients followed through that time period. The remaining patients were lost to follow up.|||participants|||Number
2631799|NCT01841970|Secondary|Recurrence of Symptoms That Had Resolved With Treatment|Number of patients with recurrence of symptoms defined as external thrombosed hemorrhoids, infection, mucous discharge, new fissure, stenosis and delayed healing.|Post treatment at Month 1, Month 3, Month 6|At Month 1, 3 and 6 the number of participants include patients followed through that time period. The remaining patients were lost to follow up.|||Participants|||Count of Participants
2631800|NCT01841970|Secondary|Incidence of Recurrence of Pre-procedure Symptoms|Recurrence of pre-procedure symptoms after initial improvement|Post treatment at Month 1, Month 3, and Month 6||||participants|||Number
2631801|NCT01841970|Primary|Number of Participants With Resolution of Symptoms|The primary endpoint analysis was the resolution of symptoms, including resolution of bleeding and prolapse, if present prior to treatment|Post treatment at Month1, Month 3, Month 6|18 participants included. 2 participants were lost to follow up.|||participants|||Number
2631802|NCT01841931|Secondary|Positive Affect|The investigators will assess patients' moods/affects using the PANAS (Positive Affect Negative Affect Scale).|6 months|Enrolled patients||||||
2631803|NCT01841931|Secondary|Quality of Life|Investigators will use the QOL (EuroQol EQ5D) questionnaire, which assess patients' self-assessment of health and health-related quality of life.|6 months|Enrolled patients||||||
2631804|NCT01841931|Secondary|Psychiatric Distress|The investigators will utilize the SCL-6 (Symptoms Checklist 6, a validated abbreviated version of the SCL-90) to assess patients' psychological well being.|6 months|Enrolled patients||||||
2631805|NCT01841931|Primary|Pain Severity|"Pain severity will be measured using a numeric scale from 0 (no pain) to 10 (pain as bad as you can imagine), adopted from the Brief Pain Inventory (BPI).~No results to report."|6 months|Enrolled patients||||||
2631807|NCT01841762|Other Pre-specified|Assessment of the Sensitivity to Detect Change in the Symptoms and Impacts Domain Scores of the PAH-SYMPACT From Baseline to Week 16.|Sensitivity to change is an aspect of construct validity and represents the instrument's ability to detect underlying change. Sensitivity to change was examined to compare the difference in mean score in each domain of the PAH-SYMPACT. The symptoms and impacts domains consisted of 11 items each reported on a 7-point Likert Scale (from 0=no symptom/with no difficulty at all/not at all to 6=very severe symptoms/very much/extremely/not able at all). An average symptoms domain score is determined based on the daily scores of the containing items. An average impacts domain score is determined based on the items in the domain.|From Screening period (Days -7 to -1) to Week 16 (7-day period prior to Week 16 visit).|Per Protocol Set of 278 subjects.|||Score on a scale||Inter-Quartile Range|Median
2631808|NCT01841762|Secondary|Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events, and Adverse Events Resulting in Patient Study Drug Discontinuation Between Time Periods, BL to End of Study Visit (EoS, Week 16+30 Days for Follow-up Safety Visits)|Safety events are reported and documented as defined in study protocol.|From Day 1 (Baseline Visit) to End of Study visit (EoS).|Safety set of 284 subjects.|||Participants|||Count of Participants
2631809|NCT01841762|Primary|Validation of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT), Assessing Internal Consistency Reliability.|The reliability of the PAH-SYMPACT is assessed by internal consistency reliability. This was determined using Cronbach's alpha-a value on an internal level scale from 0 to 1.0 with higher scores indicating a more-reliable (precise) instrument.|From ePRO period 1 (Days -14 to -8) to ePRO period 2 (Days -7 to -1) in screening period.|Per protocol set of 278.|||Ratio of variance|||Number
2631810|NCT01841762|Primary|Validation of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT), With Reliability Assessed Via Test-retest Reliability.|The reliability of the PAH-SYMPACT is assessed by test-retest reliability. Intra-class correlation coefficients (ICCs) assess test-retest reliability for the symptom and impact part scores as well as domains. ICCs equal to or greater than 0.70 are considered to demonstrate good test-retest reliability for total and domain scores.|From ePRO period 1 (Days -14 to -8) to ePRO period 2 (Days -7 to -1) in screening period.|Per Protocol Set of 278 patients.|||Intra-class correlation coefficient|||Number
2631811|NCT01841762|Primary|Development and Refinement of the Patient-reported Outcome Measure of Symptoms and Their Impact in PAH (the PAH-SYMPACT)|Content validity of the PAH-SYMPACT was assessed using item performance, exploratory and confirmatory factor analysis. The final item content and domain structure of PAH-SYMPACT was determined based on these analyses from the Steering Committee (expert clinicians) and findings from the qualitative research done with patients previously.|From Screening Visit (Day -14) to End of Treatment (EOT) Visit (Visit 4, Week 16)|Per Protocol Set (PPS) comprised all patients included in the Full Analysis Set (FAS) who had no major protocol violations.|||Items|||Number
2631812|NCT01841697|Secondary|Percentage of Participants Achieving an A1C Goal <6.5% After 24 Weeks of Treatment|Participant whole blood samples were collected at Week 24 to determine the percentage of participants achieving A1C <6.5% at Week 24.|Week 24|Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.|||Percentage of participants|||Number
2631813|NCT01841697|Secondary|Percentage of Participants Achieving an A1C Goal <7.0% After 24 Weeks of Treatment|Participant whole blood samples were collected at Week 24 to determine the number of participants achieving A1C <7.0% at Week 24.|Week 24|Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.|||Percentage of participants|||Number
2631814|NCT01841697|Secondary|Change From Baseline in FPG at Week 24|Participant whole blood samples were collected after an overnight fast at baseline and Week 24 to determine the least squares mean change from baseline in participant FPG.|Baseline and Week 24|Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
2631815|NCT01841697|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy.|Up to 24 weeks|All participants as treated population consists of all randomized participants who received at least one dose of trial treatment. Participants are included in the treatment group corresponding to the trial treatment they actually received.|||Percentage of participants|||Number
2631816|NCT01841697|Primary|Percentage of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy.|Up to 27 weeks (including 3-week follow-up)|All participants as treated population consists of all randomized participants who received at least one dose of trial treatment. Participants are included in the treatment group corresponding to the trial treatment they actually received.|||Percentage of participants|||Number
2631817|NCT01841697|Primary|Change From Baseline in A1C at Week 24|A1C is a measure of the percentage of glycated hemoglobin in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the least squares mean A1C change from baseline.|Baseline and Week 24|Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.|||Percent||95% Confidence Interval|Least Squares Mean
2631819|NCT01841632|Secondary|Evidence Confirming That MultiStem Does Not Promote Malignant Transformation or Tumor Growth|Four additional outpatient visits are planned to further evaluate the study patients (including screening for malignancies).|up to day 365 (+/-30)|A Per-protocol (PP) population consisting of all patients of the ITT population who showed no major protocol violations. Protocol violations that may have an impact on the study outcome were considered as major protocol violations.|||Participants|||Count of Participants
2631820|NCT01841632|Secondary|Time to First Biopsy-proven Acute Rejection|Per protocol biopsies will be performed on days 1, 4, 10. Additional biopsies will be taken whenever clinically necessary.|up to day 90 (+/-30)|||||||
2631821|NCT01841632|Primary|Infusional and Acute Toxicity, Using Toxicity Scoring Mechanism|"For the description of intraportal toxicity a doppler ultrasound examination will be performed to assess various parameters that describe velocity of flow and flow pattern.~For pulmonary toxicity the assessment begins with an arterial blood gas. If this reveals pathological findings, a chest X-ray is required for clinical reasons independent of the study enrolment. In addition, clinical data describing the need for postoperative re-intubation will be recorded and the patient is assessed for the occurrence of a pulmonary embolism according to clinical guidelines.~For systemic toxicity, the occurrence of anaphylactic shock due to standard clinical guidelines is recorded."|up to day 30 (+10)|A Per-protocol (PP) population consisting of all patients of the ITT population who showed no major protocol violations.|||Participants|||Count of Participants
2631822|NCT01841619|Primary|Skindex 29|The subjects also evaluated their skin-specific quality of life with the Skindex-29 − the questionnaire consisting of 29 items used to calculate three subscales: symptoms (pain, itch, burning, sensitivity), emotions (depression, anxiety, embarrassment, anger) and functioning (sleep, relationships with others). All assessments were repeated at all study visits. Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis.|Initial, 1st Visit - 9th Visit||||Percent of Baseline||Standard Deviation|Mean
2631823|NCT01841619|Secondary|Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Damage Score (CLASI - TDS)|"Disease activity will be measured using the CLASI activity score that describes the damage of the disease. This score ranges from 0-70, with higher scores indicating more severe skin disease. This clinical assessment tool enables standardized assessments of response to therapy.~Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis.~All patients were measured identically in all visits."|Initial, 1st Visit - 9th Visit||||Percent of Baseline||Standard Deviation|Mean
2631824|NCT01841619|Primary|Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Activity Score (CLASI - TAS)|"Disease activity will be measured using the CLASI activity score that describes the activity of the disease. This score ranges from 0-70, with higher scores indicating more severe skin disease. This clinical assessment tool enables standardized assessments of response to therapy.~Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis."|Initial, 1st Visit - 9th Visit||||Percent of Baseline||Standard Deviation|Mean
2631825|NCT01841619|Secondary|Mean Percent Change in Physician's Subjective Assessment of Severity (PSAS)|"At clinic visits, the investigator will categorize the change in disease activity in each patient as improved, unchanged, or worse since the last visit. Estimated change in disease activity will be based on the investigator's subjective assessment of the patient's skin disease.~Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis."|Initial, 1st Visit - 9th Visit||||Percent of Baseline||Standard Deviation|Mean
2631826|NCT01841619|Secondary|Mean Percent Change in Physician's Subjective Assessment of Improvement (PSAI)|"At clinic visits, the investigator will categorize the change in disease activity in each patient as improved, unchanged, or worse since the last visit. Estimated change in disease activity will be based on the investigator's subjective assessment of the patient's skin disease.~Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in percentage indicates worsening of CLE. Visits occur on a month-to-month basis."|Initial, 1st Visit - 9th Visit||||Percent of Baseline||Standard Deviation|Mean
2631827|NCT01841606|Primary|Change in Cardiac Output From Baseline to 20 Minutes Post-spinal|Maximum change in cardiac output from initiation of spinal anesthesia (baseline) until uterine incision (20 minutes post-spinal)|Baseline and 20 minutes||||L/min||Standard Deviation|Mean
2631828|NCT01841593|Primary|Amlodipine AUC(0-24h)|AUC0-24h: Area under the concentration time curve 24 hours in the absence, and presence, of raltegravir|Post-dose on day 7 of daily dosing||||ng*h/mL||95% Confidence Interval|Geometric Mean
2631829|NCT01841593|Primary|Raltegravir AUC(0-12h )|AUC0-12h: Area under the concentration time curve over 12 hours in the absence, and presence, of amlodipine.|Post dose after day 7 of daily dosing||||ng*h/mL||95% Confidence Interval|Geometric Mean
2631830|NCT01841593|Primary|Amlodipine C24h|measured concentration 24 hours after dose in the absence, and presence, of raltegravir|12 hours post-dose on day 7 of daily dosing.||||ng/mL||95% Confidence Interval|Geometric Mean
2631831|NCT01841593|Primary|Raltegravir C12h|measured concentration 12 hours after dose in the absence, and presence, of amlodipine.|12 hours post-dose on day 7 of daily dosing.||||ng/mL||95% Confidence Interval|Geometric Mean
2631868|NCT01840943|Secondary|Number of Participants With Overall Survival|Number of Participants With Overall survival were categorized as number of 1) Deaths, 2) Still alive, 3) Early termination from the study due to lost to follow up, 4) Early termination from the study due to withdraw of consent, 5) Other. Overall survival is defined as the time interval from randomization to death from any cause.|Week 4 after the last dose of the study medication and approximately up to 1 year after the disease progression or completion of the study treatment or death, whichever is earlier|The mITT population included all randomized participants.|||participants|||Number
2631832|NCT01841593|Primary|Maximum Observed Concentration (Cmax) of Raltegravir and Amlodipine Without and With Co-administration of the Other Studied Drug.|"To investigate the pharmacokinetics of raltegravir and amlodipine co-administration. The pharmacokinetic parameters calculated for raltegravir and amlodipine will be trough concentration (Ctrough), defined as the concentration at 24 hours after the observed drug dose, the maximum observed plasma concentration (Cmax), elimination half-life (t1/2), time point at Cmax (Tmax), and total drug exposure, expressed as the area under the plasma concentration-time curve from 0-24 hours after dosing (AUC0-24h).~All pharmacokinetic parameters will be calculated using non-compartmental modeling techniques (WinNonlin®) and all statistical calculations performed and analyzed using SAS version 9.1 or SPSS V17.0."|Day 7 of each intervention (0 (pre-dose), 2, 4, 8 and 12 hours post dose (both drugs) and 24 hours post dose (amlodipine only))|Data from all enrolled participants who participated in at least two of the three PK assessments were included in the analysis.|||ng/mL||95% Confidence Interval|Geometric Mean
2631833|NCT01841567|Secondary|Overall Cost Regarding Dressing Wear Time||7 days|||||||
2631834|NCT01841567|Secondary|Pain Evaluation||7 days|||||||
2631835|NCT01841567|Secondary|Comfort, Comformability, Acceptability of the Dressing||7 days|||||||
2631836|NCT01841567|Secondary|Number of Participants Rated 'Very Good to Excellent' for Comfort, Conformability and the Acceptability of the Dressing.|The comfort, conformability and the acceptability of the dressing were measured on all visit in the study, by a study nurses. The patient had to answer questions regarding, the size of the dressing, shape of the dressing, Visibility beneath the dressing, ease of the application of the dressing, ease of removal of the dressing, overall experience of the use of the dressing, notice any pain at dressing change, Comfort of their dressing, overall experience of their dressing. The patient could chose between 1 Good, 2 Very good, 3 Excellent.In most cases, the patient chose very good to excellent for both hip and knee surgery|7 days||||participants|||Number
2631837|NCT01841567|Primary|Minimize the Risk of the Development of Blistering.|Number of participants without blisters at study visit|7 days||||participants|||Number
2631838|NCT01841554|Other Pre-specified|Technical Success Rate of the Implantation of the Cardioband|The ability to advance the implant, load anchors, anchor the implant to tissue, and retract the Implant Delivery System.|Immediately after implantation||||Participants|||Count of Participants
2631839|NCT01841554|Other Pre-specified|Technical Feasibility of Cardioband Adjustment|The ability to connect the Adjustment Tool, reduce septo-lateral dimension, and retract the Adjustment Tool with guide wire.|Immediately after procedure||||Participants|||Count of Participants
2631840|NCT01841554|Other Pre-specified|Reduce MR [Paired Baseline and Follow-Up]|Cardioband ability to reduce mitral valve regurgitation (MR) Intra-procedure, at hospital discharge, and at 30 days. Reported as number of patients showing a reduction in MR grade greater than or equal to 1.|Post-adjustment, discharge, and 30 Days|The data is presented as paired data for patients that have baseline data and data for each individual follow up time point. The number of patients with paired data between baseline and post-adjustment, discharge, and 30 days is 47, 50 and 46, respectively.|||Participants|||Count of Participants
2631841|NCT01841554|Secondary|Performance [Full Analysis Data Set - MR Severity]|All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe).|Baseline, discharge, 6 and 12 months|The outcome is reported where data is available.|||Participants|||Count of Participants
2631842|NCT01841554|Secondary|Performance [Intra-subject Comparison - MR Severity]|All data available at each time point was reported as number of patients with MR grades between 0-1 (Trace - Mild), 2+ (Moderate), 3-4+ (Moderate - Severe).|Baseline, discharge, 6 and 12 months|Intra-subject comparison of 26 patients who were assessed for MR grade across all four time points (baseline, discharge, 6 and 12 months).|||Participants|||Count of Participants
2631843|NCT01841554|Secondary|Performance [MLHFQ]|Score on Minnesota Living with Heart Failure Questionnaire (MLHFQ). MLHFQ is composed of 21 questions relating to limitations in lifestyle associated with heart failure. Respondents use a 5 point scale from 0 to 5, with a 0 representing no limitation and 5 representing maximum limitation. The total score is computed by adding individual scores of each question. Higher scores are associated with lower quality of life.|Baseline, 6 and 12 months|Intra-subject comparison of 27 patients who had data at all three time points (baseline, 6 and 12 months).|||Scores on a scale||Standard Deviation|Mean
2631844|NCT01841554|Secondary|Performance [6MWT]|Distance in meters walked during 6 Minute Walk Test (6MWT) at baseline, 6 and 12 months.|Baseline, 6 and 12 months|Intra-subject comparison of 18 patients who had data at all three time points (baseline, 6 and 12 months).|||Meters||Standard Deviation|Mean
2631845|NCT01841554|Primary|Number of Participants With Major Serious Adverse Events and Serious Adverse Device Effects|Overall rate of Major Serious Adverse Events (SAEs) and serious adverse device effects (SADEs) until hospital discharge and at post-operative 30 days.|30 days||||Participants|||Count of Participants
2631846|NCT01841281|Secondary|Forced Expiratory Volume in One Second (FEV1)/Forced Vital Capacity (FVC)|The secondary endpoint is the change in FEV1/FVC ratio at 3 months. This calcuation is a ratio between the volume of breath exhaled in the first second divided by the total amount of breath exhaled in a vital capacity maneuver. A normal ratio is usually > 70%.|3 month|Several patients dropped after the first intervention|||ratio||Standard Deviation|Mean
2631847|NCT01841281|Primary|Number of Acute Exacerbation at 3 Months|The primary endpoint of the study is the number of acute moderate exacerbations at 3 months. A moderate asthma exacerbation is defined as any of the following: 1) A drop in morning peak flow rate (PEFR) >30% from baseline on 2 consecutive days (1 event), 2) Need for initiation of oral steroids or am increased dose of inhaled corticosteroids on any two consecutive days (1 event), 3) Doubling of short-acting β-agonist use (e.g. number of puffs of albuterol) per day for 2 consecutive days (1 event).|3 month|Several patients dropped after the first intervention|||Events||Standard Deviation|Mean
2631848|NCT01841216|Secondary|Perceived Exertion|Thera-Band(R) RISE (Resistance Intensity Scale for Exercise) Scale to measure amount of perceived exertion during resistance band exercises. This is a scale 0 to 10, 0 being extremely easy and 10 being extremely hard. The subject rated the intensity or resistance felt on each exercise on this scale. The ideal range for an exercise is in the middle of the scale (4-7) where the subject is feeling resistance but is not maximally exerted.|16 exercises during one 40 minute session||||units on a scale||Full Range|Mean
2631849|NCT01841216|Primary|Percent of Maximal Voluntary Isometric Contraction (%MVIC)|Percent of Maximal Voluntary Isometric Contraction was measured by placing EMG leads on selected muscles. Data was collected and analyzed with the MyoResearch XP Masters Edition (Noraxam Inc., Scottsdale, AZ). The EMG signals were smoothed and rectified and analyzed using a root-mean-square algorithm. We used visual onset and offset of the EMG signal amplitude to select the middle 3 of 5 trials. The middle three repetitions were analyzed. Average activation and peak activation were determined and then compared to the maximum voluntary isometric contraction (MVIC), captured during a manual muscle test, for each muscle group, and expressed as a %MVIC. The %MVIC can be greater than 100% since the MVIC is captured in a stationary, isometric position using manual force and all other activities are performed in motion against elastic or gravity resistance.|One 40 minute session||||percentage of MVIC of gmax||Standard Deviation|Mean
2631850|NCT01841073|Other Pre-specified|Percentage Change in Body Weight|Change in body weight over 9 week intervention|9 weeks||||percentage change||Standard Error|Mean
2631851|NCT01841073|Secondary|Food Intake in Gram at 9 Weeks|Food intake following intervention over 9 weeks compared to baseline and between the two group|9 weeks||||g||Standard Error|Mean
2631852|NCT01841073|Primary|Glycaemic Control|An oral glucose tolerance test (OGTT) using 75 g of glucose was performed to clarify glycaemic status.|9 weeks||||mmol//l||Standard Error|Mean
2631853|NCT01841021|Secondary|Number of Participants With Study Related Serious Adverse Events (SAEs)|Serious adverse events (SAEs) to be summarized by worst NCI NCI Common Terminology Criteria for Adverse Events (CTCAE) grade.|Up to 24 months post treatment|All participants.|||Participants|||Count of Participants
2631854|NCT01841021|Secondary|Overall Survival (OS)|Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Radiological assessments to be discontinued at the time of tumor progression or initiation of new anticancer therapy, after which survival to be evaluated every 3 months until 2 years from the start of study treatment or until study closure.|24 months post treatment or until study closure|Participants evaluable at 24 months post treatment or at study closure.||||||
2631855|NCT01841021|Secondary|Progression Free Survival (PFS)|Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Stable disease (SD) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL).|24 months post treatment|Participants evaluable at 24 months post treatment.||||||
2631856|NCT01841021|Secondary|Time to Disease Progression (TTP)|Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. Progressive disease (PD) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL).|Up to 24 months post treatment|All participants.|||months|||Number
2631857|NCT01841021|Secondary|Duration of Response (DOR)|DOR: The number of days between the first tumor response assessment of objective response (complete response and partial response) to the time of the first tumor response assessment of progressive disease (PD) or death if due to disease progression (date of first PD assessment or death due to disease progression-date of first objective response assessment +1).|Up to 24 months post treatment|Participants with Complete Response or Partial Response.||||||
2631858|NCT01841021|Secondary|Time to Response (TTR)|Investigators intended to report median time and its 95% confidence interval estimate using the Kaplan-Meier method, for 20 participants. TTR: The time from the start of treatment to the first time when the measurement criteria for CR or PR are met. Participants who did not have a confirmed response to be censored at the date of the last tumor assessment.|Up to 24 months post treatment|Participants with Complete Response or Partial Response.||||||
2631859|NCT01841021|Primary|Overall Response Rate (ORR)|ORR: The proportion of patients with complete response (CR) and partial response (PR). Follow-up assessments after cycle 16 to be done every 12 weeks for up to 24 months. Restaging imaging computed tomography (CT) scans to be repeated 12 and 24 months from the beginning of the follow-up period. Objective disease response (CR and PR) defined according to the modified 2007 International Working Group (IWG) response criteria for non-Hodgkin lymphomas (NHL). CR = Disappearance of all evidence of disease; PR = Regression of measurable disease and no new sites.|Up to 24 months post treatment|All participants.|||Participants|||Count of Participants
2631860|NCT01840943|Secondary|Number of Participants With Adverse Events|An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Grade 3 (Severe) events are symptoms causing inability to perform usual social & functional activities. Grade 4 (Life-threatening) events are Symptoms causing inability to perform basic self-care functions or Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death.|Up to 30 days after the last dose of study medication|Safety population included all randomized participants.|||participants|||Number
2631861|NCT01840943|Secondary|Apparent Volume of Distribution of Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.||||||
2631862|NCT01840943|Secondary|Systemic Clearance of Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.||||||
2631863|NCT01840943|Secondary|Apparent Terminal Elimination Rate Constant of Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.||||||
2631864|NCT01840943|Secondary|Apparent Terminal Elimination Half-life of Plasma Concentration of CAELYX||0 hour, 30 minutes, 90 minutes, 2 hours, 4 hours, 8 hours, 12 hours, Day 2, Day 3, Day 5, Day 8, and Day 11 for Cycle 1 and Cycle 2|Data was not collected for this outcome measure as the study was early terminated.||||||
2633522|NCT01823861|Primary|Use of a Effective Contraceptive Method at Four-months Post-abortion|Self-reported use of pill, coil, implant or injection for all participants. Objective measurement of contraceptive use for participants from one clinic.|4 months||||participants|||Number
2631869|NCT01840943|Secondary|Health-related Quality of Life Assessment (HQL)|Calculation of each HQL domain scale will be performed according to the scoring guidelines for each of the HQL measures. The HQL analyses will include scales measuring physical functioning, pain, nausea, fatigue, and global quality of life. Each item is measured on a scale of 0 to 3, where 0 = no impact on quality of life and 3 = extreme impact on quality of life.|Day 1 of each cycle of study medication and Week 4 after last dose of study medication|Data was not collected for this outcome measure as the study was early terminated.||||||
2631870|NCT01840943|Secondary|Duration of Response|It is calculated as the first observation of a durable response (the first of the 2 confirmatory measurements) to the first observation of disease progression or death due to any cause.|Up to 1 year of last dose (Week 24) administration|The mITT population included all randomized participants. Duration of response was analyzed for participants who achieved response.|||weeks||95% Confidence Interval|Median
2631871|NCT01840943|Secondary|Time to Response|It is calculated as the day of randomization to the first observation of a durable response (the first of the 2 confirmatory measurements).|Up to Week 24|The mITT population included all randomized participants.Time to response was analyzed for participants who achieved response.|||weeks||Full Range|Median
2631872|NCT01840943|Secondary|Number of Participants With Response|Response rate was measured as number of participants with at least a durable response: Complete response (CR) or partial response (PR). Complete response is defined as the disappearance of all target lesions. Partial response is defined as at least a 30 percentage decrease in the sum of diameters of target lesions. Stable disease defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progression in disease is defined as at least a 20% increase in the sum of diameters of target lesions. Not evaluable participants were those who were not analyzed. The reference of the baseline sum of diameters of lesions was considered.|Up to Week 24|The mITT population included all randomized participants.|||participants|||Number
2631873|NCT01840943|Secondary|Duration of Progression-free Survival|It was calculated as the time, in weeks, from the day of randomization until documented disease progression or death due to any cause, whichever occurs first using a Kaplan-Meier curve for PFS.|1 year after the last dose (24 weeks) administration|The mITT population included all randomized participants.|||weeks||95% Confidence Interval|Median
2631874|NCT01840943|Primary|Number of Participants With Progression-free Survival Incidence at Week 24|Progression-free survival incidence was be measured as number of participants who were progression-free and alive. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Week 24|The modified intent-to-treat population included (mITT) included all randomized participants.|||participants|||Number
2631875|NCT01840722|Secondary|Number of Participants Recently Receiving Physical or Behavioral Health Treatment|Is currently being treated for a physical or mental health problem OR has been in a substance use treatment program in the last 6 months|6 months|Participants were lost to study attrition.|||Participants|||Count of Participants
2631876|NCT01840722|Secondary|Number of Participants Exchanging Sex|Sex with a Partner in Exchange for Money, Drugs, Food, Shelter, Transportation, etc. in the past 6 months|6 months|Participants were lost to attrition.|||Participants|||Count of Participants
2631877|NCT01840722|Primary|Number of Participants Having Unprotected Casual Sex|Had unprotected sex with a casual partner or when trading sex for money, drugs, etc in the past 6 months|6 months|Participants were lost to study attrition|||Participants|||Count of Participants
2631878|NCT01840605|Secondary|Percentage of Participants With Patient Impression Score (Reporting Excellent or Very Well Improved in Pruritus)|Patient impression score were rated on 5-point scale ranging from 0 to 4 (4 excellent, 3 very well, 2 well, 1fair, 0 poor).|Week 2||||percentage of participants||95% Confidence Interval|Number
2631879|NCT01840605|Secondary|Severity of Atopic Dermatitis at 2 Weeks (Change From Baseline)|Severity score were rated on 5-point scale ranging from 0 (none) to 4 (severe).|Baseline and 2 weeks||||units on a scale||Standard Error|Least Squares Mean
2631880|NCT01840605|Secondary|Change From Baseline in Pruritus Score|The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).|Baseline and 1 weeks||||units on a scale||Standard Error|Least Squares Mean
2631881|NCT01840605|Primary|Change From Baseline in Pruritus Score|The pruritus symptoms score were rated on 5-point scale ranging from 0 (none) to 4 (severe).|Baseline and 2 weeks||||units on a scale||Standard Error|Least Squares Mean
2631882|NCT01840410|Secondary|Number of Primary Reasons for Decision to Treat by Investigator|The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.|Month 12|Safety set: The safety set included randomized participants who received at least one dose of study treatment and was based on the actual treatment received.|||Number of primary reasons|Participants||Number
2631883|NCT01840410|Secondary|Number of Participants With Re-treatments|The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to month 12, the maximum number of retreatments was 5.|Month 12|Safety set: The safety set included randomized participants who received at least one dose of study treatment and was based on the actual treatment received.|||Paticipants|||Number
2631884|NCT01840410|Secondary|Number of Participants With Ranibizumab Treatments in Study Eye|The number of participants administered study treatments, according to treatment frequency, was assessed.|Month 12|Safety set: The safety set included randomized participants who received at least one dose of study treatment and was based on the actual treatment received.|||Participants|||Number
2631885|NCT01840410|Secondary|Number of Participants With Requirement for Rescue Treatment at Month 1|Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of > 5 letters due to disease activity from baseline to Month 1.|Month 1|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at Month 1, were analyzed.|||Participants|||Number
2633523|NCT01823679|Secondary|Overall Survival (OS) at 2 Years|Proportion of participants with overall survival (OS) at 2 years, as calculated based on Kaplan-Meier estimates.|2 years||||percentage of participants|||Number
2631886|NCT01840410|Secondary|Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss|VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.|Month 2, Month 6, Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.|||Participants|||Number
2631887|NCT01840410|Secondary|Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters|VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.|Month 2, Month 6, Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.|||Participants|||Number
2631888|NCT01840410|Secondary|Average Change From Baseline in BCVA|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. BCVA was assessed at each month from Month 1 through Month 6 or at each month from Month 1 through month 12, and the data were averaged. The outcome measure is reporting the change between baseline and average BCVA from Month 1 through Month 6 or from Month 1 through Month 12 (average BCVA - baseline BCVA). A positive change from baseline indicated improvement.|Baseline (BL), Month 1 through Month 6, Month 1 through Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.|||letters||Standard Deviation|Mean
2631889|NCT01840410|Secondary|Number of Participants With Presence of Active Chorioretinal Leakage|The presence of active chorioretinal leakage was assessed by photography imaging, i.e. fluorescein angiography (FA).|Baseline, Month 2, Month 6, Month 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.|||Participants|||Number
2631890|NCT01840410|Secondary|Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline|Presence of subretinal fluid in study eye compared to baseline|Baseline, Month 2, Month 6, Month 12|The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.|||Participants|||Number
2631891|NCT01840410|Secondary|Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline|The presence of intra-retinal fluid was assessed by OCT.|Baseline, Month 2, Month 6, Month 12|The FAS was considered for the analysis. The FAS included all randomized participants who received at least one dose of study treatment. Only participants (n), with values 'Absent' or 'Definite' for both the baseline and corresponding post-baseline time point, were included in the analysis.|||Participants|||Number
2631892|NCT01840410|Secondary|Change From Baseline in Central Subfield Volume (CSFV) in Study Eye|CSFV was assessed OCT. A negative change from baseline indicates improvement.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.|||microliter (ul)||Standard Deviation|Mean
2631893|NCT01840410|Secondary|Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye|CSFT was assessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.|Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.|||micrometer (um)||Standard Deviation|Mean
2631894|NCT01840410|Secondary|Change From Baseline in BCVA in Study Eye up to Month 2|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using analysis of covariance (ANCOVA) model which contained the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate. A positive change from baseline indicated improvement.|Baseline, Month 1, Month 2|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and the given post-baseline time point, were analyzed for that post-baseline time point.|||letters||Standard Error|Least Squares Mean
2631895|NCT01840410|Primary|Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2|BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using mixed model repeated measures (MMRM) which contained scheduled visit, the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate and treatment group by visit and visit by centered baseline BCVA interactions. A positive change from baseline indicated improvement.|Baseline, Month 2|The full analysis set (FAS) was considered for the analysis. The FAS included all participants who were randomized to treatment. Only participants, with available data at both baseline and Month 2, were analyzed.|||letters||Standard Error|Least Squares Mean
2631896|NCT01840345|Secondary|Stress|Stress will be measured by the Perceived Stress Scale ((PSS), a 10-item instrument for measuring the perception of stress, with total scores ranging from 0-40. Higher scores = higher perceived stress|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
2631897|NCT01840345|Secondary|Mood|Mood will be assessed by using the Patient Health Questionnaire (PHQ-9), a validated 9-question assessment of depression with total scores ranging from 0-27. Higher score = worse depression.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
2653318|NCT01644240|Primary|AUC0-∞|Area under the concentration time curve from time 0 to infinity.|Day 1||||pg*hr/mL||Standard Deviation|Mean
2631899|NCT01840345|Primary|Opioid Use|The amount of opioid medication used was recorded. Then, it was converted to morphine equivalents (https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Opioid-Morphine-EQ-Conversion-Factors-March-2015.pdf). Opioid use was measured over a 2-week baseline period. Then, the average opioid medication use/week was calculated. This was compared to the average opioid medication use/week after 4 weeks of NAC.|Baseline, 4 weeks||||morphine equivalent dose||Standard Deviation|Mean
2631900|NCT01840319|Primary|Percentage of Participants With Survival at 30 Days After Last Dose of Tigecycline|Survival analysis was calculated using Kaplan-Meier Method. The survival status of participants from the initial study database were collected for survival analysis, if participants did not have the data in the database, the participating clinician requested the vital status information from the center for epidemiology and population health research (CESP). The deceased participants' data were collected and the informed consent form was sent to surviving participants. The existing and the collected survival data were then merged and updated. A survival analysis was performed including a variable treatment period plus 30 follow-up days. The maximum treatment duration observed in the initial study was 78 days. Percentage of participants who were alive at 30 days after last dose (corresponding to Day 108 after first dose of tigecycline) of tigecycline were reported.|30 days after last dose of Tigecycline (Day 108)|Intent-to-treat (ITT) population included all participants of the initial study 3074A1-4448 (B1811030) (NCT00799591).|||percentage of participants||95% Confidence Interval|Number
2631901|NCT01840228|Secondary|Composite Neonatal Outcome|A composite neonatal outcome comprising neonatal death, respiratory distress syndrome, bronchopulmonary dysplasia, severe (grade III/IV) interventricular hemorrhage, necrotizing enterocolitis, and sepsis.|Followed for duration of neonatal hospital stay, estimated maximum 16 weeks||||Participants|||Count of Participants
2631902|NCT01840228|Secondary|Number of Participants With Chorioamnionitis||Duration of current pregnancy, anticipated maximum 18 weeks||||Participants|||Count of Participants
2631903|NCT01840228|Secondary|Neonatal Intensive Care Unit Admission||Followed for duration of neonatal hospital stay, estimated maximum 16 weeks||||Participants|||Count of Participants
2631904|NCT01840228|Secondary|Infant Birth Weight||Day of delivery in current pregnancy||||grams||Standard Deviation|Mean
2631905|NCT01840228|Secondary|Number of Weeks Pregnancy Prolongation||Duration of current pregnancy, anticipated maximum 18 weeks||||weeks||Inter-Quartile Range|Median
2631906|NCT01840228|Secondary|Delivery Within 2 Weeks of Randomization||2 weeks||||Participants|||Count of Participants
2631907|NCT01840228|Secondary|Number of Participants Who Delivered Before 34 Weeks'|Evaluated in women enrolled prior to 32 weeks gestation|Duration of current pregnancy, anticipated maximum 18 weeks||||Participants|||Count of Participants
2631908|NCT01840228|Primary|Number of Participants Who Delivered Before 37 Weeks'||Duration of current pregnancy, anticipated maximum 18 weeks||||Participants|||Count of Participants
2631909|NCT01840163|Secondary|Patient Subjective Decision Quality for Systemic Breast Cancer Treatment|A 4 item subjective decision quality scale measured how satisfied patients were with their chemotherapy treatment decision. Patients were asked to rate the amounts of information, involvement, time, and overall satisfaction associated with their chemotherapy decisions. Possible responses ranged from 'not enough' to 'just right' to 'too much'. All responses were assigned values from 1 to 5, with a response of 'just right' coded as 5 points, and both 'not enough' and 'too much' coded as 1 point. The values of all 4 items were combined using the arithmetic mean, to create a standardized scale ranging from 1 (low decision quality) to 5 (high decision quality). The subjective decision quality scale was used as an outcome in linear mixed models to determine the effect of intervention on patient decision quality.|9 months after enrollment||||units on a scale||Standard Deviation|Mean
2631910|NCT01840163|Secondary|Patient Preparedness Decision Making for Systemic Treatment|A 10-item decision preparedness scale asked whether the web intervention helped patients prepare for their treatment decision. Each item asked about a different aspect of decision preparation, with responses of 'not at all'/'a little'/'somewhat'/'quite a bit'/'a great deal'. Each response was assigned a value of 1('not at all') to 5('a great deal'), with a high value representing a greater amount of preparedness. The values of all 10 items were combined using the arithmetic mean, to create a standardized scale ranging from 1(not at all) to 5 (a great deal). The decision making scale was modeled by linear mixed model to determine the effect intervention on patient preparation for decision making.|9 months after enrollment||||units on a scale||Standard Deviation|Mean
2631911|NCT01840163|Secondary|Number of Patients With Accurate Knowledge About Risks and Benefits of Systemic Treatment Options for Breast Cancer|Self-reported knowledge about systemic treatment using a 5 item Breast Cancer Knowledge Measure (adapted) consisting of 5 questions to test patients' knowledge about systemic treatment options for breast cancer. We compared the number of patients who gave correct answers to at least 80% of the questions between two groups. We used both unadjusted and adjusted generalized linear mixed models with logit as the link function.|9 months after enrollment|The numbers analyzed for these secondary outcomes were taken from the study's systemic portion of the study which took place 9 months after enrollment at which point response rate dropped and therefore numbers are less than those for primary outcomes which were done 4-5 weeks after enrollment.|||Participants|||Count of Participants
2631912|NCT01840163|Secondary|Patient Subjective Decision Quality for Locoregional Breast Cancer Treatment|A 5 item subjective decision quality scale measured how satisfied patients were with their treatment decision. Patients were asked how well they agreed with 5 statements, with responses of 'not at all'/'a little bit'/'somewhat'/'quite a bit'/'very much'. All responses were assigned values from 1 to 5, with higher values reflecting greater decision satisfaction. Two of the statements reflected satisfaction with the decision and were coded as 1 for 'not at all' through 5 for 'very much'. The other three statements reflected dissatisfaction with the decision and were coded as 5 for 'not at all' through 1 for 'very much' The values of all 5 items were combined using the arithmetic mean, to create a standardized scale ranging from 1 (not at all) to 5 (very much). The subjective decision quality scale was modeled by linear mixed model to determine the effect of intervention on patient response.|4-5 weeks from date of enrollment||||units on a scale||Standard Deviation|Mean
2632016|NCT01838863|Post-Hoc|Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG) activated clotting time (ACT).|after injury and prior to hospital arrival, at about 15 minutes after injury||||second||Inter-Quartile Range|Median
2631913|NCT01840163|Secondary|Patient Deliberation for Locoregional Breast Cancer Treatment.|A 4 item Breast Cancer Treatment Deliberation Scale asked how deliberative patients were in making their treatment decision. The items asked how often they performed deliberative activities with answers of 'not at all'/'a little'/'somewhat'/'quite a bit'/'a lot'. Each response was assigned a value of 1('not at all') to 5('a lot), with a high value representing a greater amount of deliberation. The values of all 4 items were combined using the arithmetic mean, to create a standardized scale ranging from 1 (not at all) to 5 (a lot). The deliberation scale was then modeled using linear mixed models to determine the effect of the intervention on patient deliberation.|4-5 weeks from date of enrollment|participants|||units on a scale||Standard Deviation|Mean
2631914|NCT01840163|Secondary|Patient Preparedness Decision Making for Locoregional Treatment.|A 12 item decision preparedness scale asked whether the web intervention helped patients prepare for their treatment decision. Each item asked about a diefferent aspect of decision preparation, with responses of 'not at all'/'a little'/'somewhat'/'quite a bit'/'a great deal'. Each response was assigned a value of 1('not at all') to 5('a great deal'), with a high value representing a greater amount of preparedness. The values of all 12 items were combined using the arithmetic mean, to create a standardized scale ranging from 1(not at all) to 5 (a great deal). The decision making scale was modeled by linear mixed model to determine the effect intervention on patient preparation for decision making.|4-5 weeks from date of enrollment||||units on a scale||Standard Deviation|Mean
2631915|NCT01840163|Primary|Number of Patients Choosing a Treatment Option for Locoregional Treatment That Was Values Concordant|Self reported values were evaluated using a 5 item question set adapted from Decision Quality Instrument. The questions determined patient desire for outcomes such as keeping their natural breast and avoiding radiation on a scale from 0 to 10. Patients were classified as values-concordant if their actual treatment aligned with their values score predicted treatment and otherwise were classified as non-concordant. The binary values-concordance variable was modeled as a function of intervention effect using both unadjusted and adjusted logistic mixed model regression.|4-5 weeks from date of enrollment||||Participants|||Count of Participants
2631916|NCT01840163|Primary|Number of Patients With Accurate Knowledge About Risks and Benefits of Treatment Options for Locoregional Breast Cancer.|Self reported knowledge about locoregional treatment using a 5 item Breast Cancer Knowledge Measure (adapted). A binary knowledge indicator was created for all patients whereby high knowledge indicated for patients scoring greater than 80% on the item scale. The binary knowledge variable was analyzed for intervention effect using both unadjusted and adjusted logistic mixed model regression.|4-5 weeks from date of enrollment||||Participants|||Count of Participants
2631917|NCT01840072|Secondary|Quality of Life|Due to limited funding, quality of life data were not collected.|3 months|||||||
2631918|NCT01840072|Secondary|Cognitive Function (Montreal Cognitive Assessment)|Cognitive function was measured by Montreal Cognitive Assessment at 3 months after randomization. The MoCA is a 30-item test that evaluates the following seven cognitive domains: visuospatial/executive functions, naming, memory, attention, language, abstraction, and orientation. One point is added for participants with education <12 years. Scores on the MoCA range from 0 to 30 and cognitive impairment was defined as a score of <26.|Three months|In a pre-planned ancillary study, 660 participants were systemically selected prior to randomization for cognitive function assessment. At the 3-month visit, 15 patients were lost to follow-up and 7 patients were deceased. A total of 638 participants who completed the cognitive function tests were included in this analysis.|||MoCA score||Inter-Quartile Range|Median
2631919|NCT01840072|Secondary|Cognitive Function (the Mini-Mental State Examination)|Cognitive function was measured by the Mini-Mental State Examination at 3 months after randomization. The MMSE contains 20 items that test cognitive performance in domains including orientation, registration, attention and calculation, recall, language, and visual construction. MMSE scores were divided into three ordinal categories: 24-30 (no cognitive impairment), 19-23 (mild cognitive impairment), and 0-17 (severe cognitive impairment).|Three months|In a pre-planned ancillary study, 660 participants were systemically selected prior to randomization for cognitive function assessment. At the 3-month visit, 15 patients were lost to follow-up and 7 patients were deceased. A total of 638 participants who completed the cognitive function tests were included in this analysis.|||MMSE score||Inter-Quartile Range|Median
2631920|NCT01840072|Secondary|Long-term Neurological and Functional Status|Those patients who were still alive at hospital discharge were contacted by telephone to set up a follow-up clinical visit. Neurological function was assessed by the modified Rankin scale at the 3-month post-treatment follow-up visit. Scores on the modified Rankin Scale range from 0 to 6, with a score of 0 indicating no symptoms; a score of 5 indicating severe disability (ie, bedridden, incontinent, or requiring constant nursing care and attention); and a score of 6 indicating death. Major disability was defined as a score of 3 to 5 on the modified Rankin Scale.|Three months|Those patients who are still alive and followed at 3-Month posttreatment follow-up visit|||Score on modified Rankin scale||Inter-Quartile Range|Median
2631921|NCT01840072|Secondary|Other Vascular Events|Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information of vascular events, such as myocardial infarction, will be collected.|3 months||||participants|||Number
2631922|NCT01840072|Secondary|Recurrent Stroke|Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information of recurrent stroke will be collected.|3 months||||participants|||Number
2631923|NCT01840072|Secondary|Mortality|Those patients who are still alive at hospital discharge will be contacted by telephone to set up a follow-up clinical visit. Information on clinical deaths will be obtained.|3 months|All participants followed at 3-month posttreatment follow-up visit|||participants|||Number
2631924|NCT01840072|Secondary|A Combination of All-cause Mortality and Major Disability at the 3-month Post-treatment Follow-up.|Major disability was defined as a score of 3 to 5 on the modified Rankin Scale at 3 months after randomization. Scores on the modified Rankin Scale range from 0 to 6, with a score of 0 indicating no symptoms; a score of 5 indicating severe disability (ie, bedridden, incontinent, or requiring constant nursing care and attention); and a score of 6 indicating death|3 months|All participants examined at 3-month posttreatment follow-up visit|||Participants|||Count of Participants
2632017|NCT01838863|Other Pre-specified|Time to Admission and First Blood Transfusion|Time to admission and first blood product transfusion in minutes.|Hospital stay up to 28 days.||||minutes||Inter-Quartile Range|Median
2631925|NCT01840072|Primary|A Combination of Death Within 14 Days After Randomization and Major Disability at 14 Days or at Hospital Discharge if Earlier Than 14 Days.|Major disability was defined as a score of 3 to 5 on the modified Rankin Scale at 14 days after randomization. Scores on the modified Rankin Scale range from 0 to 6, with a score of 0 indicating no symptoms; a score of 5 indicating severe disability (ie, bedridden, incontinent, or requiring constant nursing care and attention); and a score of 6 indicating death.|2 weeks||||participants|||Number
2631926|NCT01839916|Secondary|Treatment-related Mortality|Estimated by cumulative incidence method. Cumulative incidence of treatment-related mortality with relapse of the original disease as the competing risk will be calculated.|At 2 year|Patients received at least one DLI treatment.|||percentage of patients||95% Confidence Interval|Number
2631927|NCT01839916|Secondary|Rate of Chronic GVHD (cGVHD)|Estimated by cumulative incidence method.|At 1 year and 2 year|Patients received at least one DLI treatment.|||percentage of patients||95% Confidence Interval|Number
2631928|NCT01839916|Secondary|Rate of Acute GVHD (aGVHD) With Any Grade|Estimated by cumulative incidence method.|At 1 year and 2 year|Patients received at least one DLI Treatment.|||percentage of patients||95% Confidence Interval|Number
2631929|NCT01839916|Secondary|Overall Survival (OS)|Computed using the Kaplan-Meier product-limit estimate and expressed as probabilities with a 95% CI.|At 2 years|Patients received at least one DLI Treatment.|||percentage of patients||95% Confidence Interval|Number
2631930|NCT01839916|Secondary|Progression Free Survival (PFS)|Time to relapse or death as a result of any cause was evaluated at 2 years and the progression free survival rate was reported.|2 years|Patients received at least one DLI Treatment.|||percentage of patients||95% Confidence Interval|Number
2631931|NCT01839916|Primary|Percentage of Patients Who Are Able to Receive at Least One DLI Treatment||Up to 2 years||||Participants|||Count of Participants
2631932|NCT01839708|Secondary|Measured Body Weight|measured body weight in person at WIC office|Immediatly after the 16-week intervention (T2)||||lbs||Standard Deviation|Mean
2631933|NCT01839708|Secondary|T3 Stress|Self-report using the Perceived Stress Scale (9 items) to measure stress perception. Participants were asked about their perception of stress in the past month. Response options were scored on a 4-point scale ranging from 1 (rarely or never) to 4 (usually or always). The overall stress score was the mean of the 9-item scores, with a higher score indicating lower stress.|3-month after the 16-week intervention||||units on a scale||Standard Deviation|Mean
2631934|NCT01839708|Secondary|T2 Stress|Self-report using the Perceived Stress Scale (9 items) to measure stress perception. Participants were asked about their perception of stress in the past month. Response options were scored on a 4-point scale ranging from 1 (rarely or never) to 4 (usually or always). The overall stress score was the mean of the 9-item scores, with a higher score indicating lower stress.|immediatly after the 16-week intervention||||units on a scale||Standard Deviation|Mean
2631935|NCT01839708|Secondary|T3 Physical Activity|Self-reported using the Pregnancy Infection and Nutrition 3 survey (24 items/activities). Participants reported frequency and duration (in hours) of physical activity that was done in seven categories and in the past 7 days. These categories were recreation (4 activities), indoor (5 activities) and outdoor (4 activities) household tasks, child and adult care (5 activities), transportation (2 activities) and activity at work and school (4 items). We first calculated hours spent on (frequency x duration) each activity, then sum all activities from 7 categories to create the total hours of moderate physical activity in the past 7 days (range 0 to 72 hours/past 7 days). The more hours, the more physical activity.|3-month after the 16-week intervention||||Hours||Standard Deviation|Mean
2631936|NCT01839708|Secondary|T2 Physical Activity|Self-reported using the Pregnancy Infection and Nutrition 3 survey (24 items/activities). Participants reported frequency and duration (in hours) of physical activity that was done in seven categories and in the past 7 days. These categories were recreation (4 activities), indoor (5 activities) and outdoor (4 activities) household tasks, child and adult care (5 activities), transportation (2 activities) and activity at work and school (4 items). We first calculated hours spent on (frequency x duration) each activity, then sum all activities from 7 categories to create the total hours of moderate physical activity in the past 7 days (range 0 to 72 hours/past 7 days). The more hours, the more physical activity.|immediatly after the 16-week intervention||||Hours||Standard Deviation|Mean
2631937|NCT01839708|Secondary|T3 Fruit and Vegetable Intake|self-reported fruit and vegetable intake (7 items total). Responses to each fruit and vegetable intake item were rated on a 6-point scale and were rated as 0 = less than 1 time per week, 1 = once a week, 2 = 2-3 times a week, 3 = 4-6 times a week, 4 = once a day, and 5 = 2 or more times a day. Summed responses ranged from 0 to 35.|3-month after the 16-week intervention||||units on a scale||Standard Deviation|Mean
2631938|NCT01839708|Secondary|T2 Fruit and Vegetable Intake|self-reported fruit and vegetable intake (7 items total). Responses to each fruit and vegetable intake item were rated on a 6-point scale and were rated as 0 = less than 1 time per week, 1 = once a week, 2 = 2-3 times a week, 3 = 4-6 times a week, 4 = once a day, and 5 = 2 or more times a day. Summed responses ranged from 0 to 35.|immediately after the 16-week intervention||||units on a scale||Standard Deviation|Mean
2631939|NCT01839708|Secondary|T3 Fat Intake|self-reported fat intake behavior using Rapid Food Screener (17 items total). Responses to each fat intake item were rated on a 5-point scale ranging from 0 (1 time or less per month) to 4 (5 or more times per week). Summed responses ranged from 0 to 68.|3-month after the 16-week intervention||||units on a scale||Standard Deviation|Mean
2631940|NCT01839708|Secondary|T2 Fat Intake|self-reported fat intake behavior using Rapid Food Screener (17 items total). Responses to each fat intake item were rated on a 5-point scale ranging from 0 (1 time or less per month) to 4 (5 or more times per week). Summed responses ranged from 0 to 68.|immediately after the 16-week intervention||||units on a scale||Standard Deviation|Mean
2631941|NCT01839708|Secondary|T1 Stress|Self-report using the Perceived Stress Scale (9 items) to measure stress perception. Participants were asked about their perception of stress in the past month. Response options were scored on a 4-point scale ranging from 1 (rarely or never) to 4 (usually or always). The overall stress score was the mean of the 9-item scores, with a higher score indicating lower stress.|baseline||||units on a scale||Standard Deviation|Mean
2632018|NCT01838863|Other Pre-specified|Number of Blood Products Transfused.|Number of blood products transfused in units.|Hospital stay up to 28 days.||||units||Inter-Quartile Range|Median
2631942|NCT01839708|Secondary|T1 Physical Activity|Self-reported using the Pregnancy Infection and Nutrition 3 survey (24 items/activities). Participants reported frequency and duration (in hours) of physical activity that was done in seven categories and in the past 7 days. These categories were recreation (4 activities), indoor (5 activities) and outdoor (4 activities) household tasks, child and adult care (5 activities), transportation (2 activities) and activity at work and school (4 items). We first calculated hours spent on (frequency x duration) each activity, then sum all activities from 7 categories to create the total hours of moderate physical activity in the past 7 days (range 0 to 72 hours/past 7 days). The more hours, the more physical activity.|baseline||||hours||Standard Deviation|Mean
2631943|NCT01839708|Secondary|T1 Fruit and Vegetable Intake|self-reported fruit and vegetable intake (7 items total). Responses to each fruit and vegetable intake item were rated on a 6-point scale and were rated as 0 = less than 1 time per week, 1 = once a week, 2 = 2-3 times a week, 3 = 4-6 times a week, 4 = once a day, and 5 = 2 or more times a day. Summed responses ranged from 0 to 35.|baseline||||units on a scale||Standard Deviation|Mean
2631944|NCT01839708|Secondary|T1 Fat Intake|self-reported fat intake behavior using Rapid Food Screener (17 items total). Responses to each fat intake item were rated on a 5-point scale ranging from 0 (1 time or less per month) to 4 (5 or more times per week). Summed responses ranged from 0 to 68.|baseline||||units on a scale||Standard Deviation|Mean
2631945|NCT01839708|Primary|Measured Body Weight|measured body weight in person at WIC office|3 months after the 16-week intervention (T3)|The inconsistent number of participants that were reported because we conducted general linear mixed model for repeated measures, which is a partial intention-to-treat analysis (ITT), adjusting baseline assessment. We chose to perform this method without any ad hoc imputation as our approach to ITT because the overall high dropout was high|||lbs||Standard Error|Mean
2631946|NCT01839695|Primary|Primary Effectiveness Observation|Treatment success which is defined as technical success (successful delivery and deployment of the stent graft in the planned location with no unintentional coverage of other vessels, assessed intraoperatively, and the removal of the delivery system) and successful exclusion of the aneurysm while maintaining patency of the MSG and BSG at the 30 day visit.|1 month|Based on the number of ITT subject with evaluable data, subjects were considered unevaluable for treatment success if the 30 day imaging was unable to assess patency of the MSG and BSG. One subject completed CT imaging at discharge, which was not repeated at the 30 day visit, and, therefore, was not considered evaluable for this assessment.|||participants|||Number
2631947|NCT01839695|Primary|Primary Safety Observation - Rate of Major Adverse Events (MAEs)|Major Adverse Events is a composite endpoint that includes Aneurysm Related Mortality (ARM), Stroke, Paraplegia, and Left Arm/Hand Ischemia.|1 month|Includes active subjects in the ITT population at 30 days post-index procedure.|||participants|||Number
2631948|NCT01839656|Secondary|PK Parameters of Nusinersen in Plasma: Area Under the Plasma Concentrations Time Curve From the Time of the IT Dose to Four Hours After Dosing (AUC0-4)|AUC is area under the plasma concentration-time curve from zero time (Predose) to 4 hours after IT administration of study drug. AUC was determined by using the linear trapezoidal rule.|Day 1 (Predose and 1, 2, and 4 hours [hr] Postdose) and Day 2 (24 hr Postdose )|PK Population: All participants who were registered and had at least 1 evaluable postdose PK sample.|||ng x hr/mL||Standard Deviation|Mean
2631949|NCT01839656|Secondary|PK Parameters of Nusinersen in Plasma: Time to Reach Cmax (Tmax)|Tmax is the time at which Cmax occurs.|Day 1 (Predose and 1, 2, and 4 hours [hr] Postdose) and Day 2 (24 hr Postdose )|PK Population: All participants who were registered and had at least 1 evaluable postdose PK sample.|||hr||Standard Deviation|Mean
2631950|NCT01839656|Secondary|PK Parameters of Nusinersen in Plasma: Maximum Concentration (Cmax)|Cmax is the maximum observed concentration of study drug in plasma.|Day 1 (Predose and 1, 2, and 4 hours [hr] Postdose) and Day 2 (24 hr Postdose )|PK Population: All participants who were registered and had at least 1 evaluable postdose PK sample.|||ng/mL||Standard Deviation|Mean
2631951|NCT01839656|Secondary|Concentration of Nusinersen in Cerebrospinal Fluid (CSF)|The concentration of nusinersen in CSF was measured by using standard laboratory assays.|Day 1135 (Predose)|PK Population: All participants who were registered and had at least 1 evaluable postdose PK sample. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
2631952|NCT01839656|Secondary|Number of Participants Experiencing Adverse Events (AEs) and/or Serious Adverse Events (SAEs)|AE: any unfavorable and unintended sign, symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. SAE: any AE that in the view of either the Investigator or Sponsor, meets any of the following criteria: results in death; is life threatening: that is, poses an immediate risk of death at the time of the event; requires in-patient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect in the offspring of the subject (whether male or female); is an important medical event in the opinion of the Investigator or Sponsor.|Up to Day 1352|Safety Population: All participants who were registered and received at least 1 dose of nusinersen.|||participants|||Number
2631953|NCT01839656|Secondary|Change in Neuromuscular Electrophysiology at the Last Visit as Assessed by the Change From Baseline in CMAP Amplitude|CMAP is an electrophysiological technique that can be used to determine the approximate number of motor neurons in a muscle or group of muscles. A positive change from Baseline indicates that the number of motor neurons increased.|Baseline, Day 1072|Safety Population: All participants who were registered and received at least 1 dose of nusinersen. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||mV||Standard Deviation|Mean
2631954|NCT01839656|Secondary|Percent of Participants With Improved Motor Function at the Last Visit as Assessed by the CHOP-INTEND Motor Function Scale|The CHOP-INTEND test includes 16 items structured to move from easiest to hardest with the grading including gravity eliminated (lower scores) to antigravity movements (higher scores). All item scores range from 0 (worst) to 4 (best). Total scores range from 0 to 64, with higher scores indicating better movement functioning. Improvement was defined as an increase in total CHOP INTEND score ≥4 points from baseline as of the last study visit.|Day 1352 or Early Termination|Safety Population: All participants who were registered and received at least 1 dose of nusinersen.|||Percent of participants|||Number
2631955|NCT01839656|Secondary|Event-free Survival at the End of Study|Event-free survival was defined as the percent of participants who were alive and did not require permanent ventilatory support (defined as tracheostomy or the need for ≥16 hours ventilation/day continuously for at least 2 weeks in the absence of an acute reversible illness) Event-free survival was estimated using Kaplan-Meier methodology.|Up to Day 1638|Safety Population: All participants who were registered and received at least 1 dose of nusinersen.|||Percent of participants|||Number
2631956|NCT01839656|Primary|Percent of Participants Who Achieved Improvement in Motor Milestones as Assessed by Section 2 of the HINE at the Last Visit|Section 2 of HINE consists of 8 independent milestone categories. Within each of these categories, participants can progress from complete absence of a motor ability (the lowest level in each category) through multiple milestones (2 to 4 levels in each category) to the highest level within the category. Overall, there are a total of 26 milestones that can be achieved across the 8 categories. Improvement was defined as any of the following: 1. An increase from baseline of 2 milestones or more, or the achievement of pincer grasp in the voluntary grasp category 2. An increase from baseline of 2 milestones or more, or achievement of touching toes in the ability to kick category 3. An increase from baseline of 1 milestone or more in any of the remaining 6 categories: head control, rolling, sitting, crawling, standing, or walking.|Day 1352 or Early Termination|Safety Population: All participants who were registered and received at least 1 dose of nusinersen.|||Percent of participants|||Number
2631957|NCT01839604|Secondary|Evaluation of Pharmacokinetics (PK) of AZD9150 (Following Single Administrations in Patients With HCC) by Determining Tmax, Using the Plasma Concentration Data.|8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1. For additional 6 patients in Japan, 8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1.|8 times of PK sampling on Day1 of Cycle1. Additional 6 patients in Japan; 8 times of PK sampling on Day 1 of Cycle 1.|PK: All dosed patients with reportable AZD9150 plasma concentrations and no important adverse events or protocol deviations that may impact PK|||h||Full Range|Median
2631958|NCT01839604|Secondary|Preliminary Assessment of the Anti-tumour Activity of AZD9150 by Evaluation of Tumour Response.|Tumour response assessment by modified Response Evaluation Criteria in Solid Tumours (RECIST). Overall tumour response: assessed by mRECIST for HCC overall visit response of CR (disappearance of baseline TLs and NTLs), PR (>=30% decrease in sum of TLs), SD (neither PR nor PD), PD (sum TLs increased >20%), or NE .|Every 6 weeks, assessed up to 12 months.|Evaluable for response: Dosed patients with measurable disease at baseline|||participants with Partial Response|||Number
2631959|NCT01839604|Secondary|Evaluation of Pharmacokinetics (PK) of AZD9150 (Following Single Administrations in Patients With HCC) by Determining Cmax, Using the Plasma Concentration Data.|8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1. For additional 6 patients in Japan, 8 times (pre-dose, 1.5, 3, 3.5, 4, 6, 8, 24 hours post-dose) on Day1 of Cycle1. From the multiple samples a timecourse is obtained of treatment conc in the plasma over time. From this curve the associated PK parameters e.g. Cmax are obtained. For n patients we obtain up to n parameters which can then be averaged.|8 times of PK sampling on Day1 of Cycle1. Additional 6 patients in Japan; 8 times of PK sampling on Day1 of Cycle1.|PK: All dosed patients with reportable AZD9150 plasma concentrations and no important adverse events or protocol deviations that may impact PK|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2631960|NCT01839604|Primary|Number of Participants With Dose Limiting Toxicities During Cycle 1|Cycle 1 was defined as 3 loading doses given on Days 1, 3, and 5 followed by 3 weekly doses given on Days 8, 15, and 22.|DLT assessment window - Cycle 1 (22 days)|Safety: All patients who received at least 1 dose of AZD9150|||participants with DLT|||Number
2631961|NCT01839396|Secondary|Secondary Endpoints|"Change in Unified Parkinson's Disease Rating Scale (UDPRS) Part III (stim on/meds off) from baseline to 12 weeks post randomization.~Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state."|From baseline to 12 weeks post-randomization||||units on a scale||Standard Deviation|Mean
2631962|NCT01839396|Primary|Change in ON Time as Measured by Parkinson's Disease Diary|Difference in the mean change from baseline to 12 weeks post-randomization between the active and control groups in the ON time as measured by Parkinson's diary. Positive indicates improvement|From baseline to 12 weeks post-randomization||||hours||Standard Deviation|Mean
2631963|NCT01839318|Secondary|Total Wettability Score|The investigator graded lens wettability by corneal region using a scale from 0 (fully wettable) to 3 (clearly visible ring distortions in more than 1/3 of ring reflection zone). The total wettability score per eye was calculated by averaging the grade of each of the 5 corneal regions (central, superior, nasal, inferior, and temporal). One eye (right eye) contributed to the mean.|Hour 8|This analysis population includes all participants exposed to the study product with reportable values.|||units on a scale||Standard Deviation|Mean
2631964|NCT01839318|Primary|Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean.|Hour 8|This analysis population includes all participants exposed to the study product with reportable values.|||seconds||Standard Deviation|Mean
2631965|NCT01839279|Secondary|Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCt) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State.||0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg)|PK Analysis set: all subjects from Group 1 who received at least one study drug and have at least one valid PK assessment|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2631966|NCT01839279|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State.||0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg)|PK Analysis set: all subjects from Group 1 who received at least one study drug and have at least one valid PK assessment|||hour||Full Range|Median
2631967|NCT01839279|Secondary|Maximum Plasma Concentration (Cmax) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State.||0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg)|PK Analysis set: all subjects from Group 1 who received at least one study drug and have at least one valid PK assessment|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2631968|NCT01839279|Secondary|Assessing the Relationship Between Changes in the QTc Interval and Plasma Levels of Tizanidine Using Concentration-effect Modeling|The relationship will be quantified using a linear mixed effects model with an intercept. Data from Day 5 and Day 14 were fitted into regression model to obtain a slope of change. The measure type 'Number' followed by (90% Confidence Interval) shown in results is the slope from the linear fit.|Day 5, Day 14|Pk/QTc Analysis set will include all subjects in the QT/QTc analysis set with at least one valid PK assessment. Effect of moxifloxacin was as expected. Therefore, no analysis required per Medical Monitor.|||msec per ng/mL||90% Confidence Interval|Number
2631969|NCT01839279|Secondary|The Baseline-adjusted, Placebo-corrected (ΔΔQTc) on QTc Method Not Selected as Primary Endpoint.|Change from baseline in Cardiac Repolarization (QTc Interval) at Day 5 (Tizanidine 8 mg). Moxifloxacin was not investigational drug, it was used to assess the sensitivity of the study.|Baseline and Day 5|QT/QTc Analysis set: Received at least 1 dose of study drug (including placebo), had measurements at baseline and on-treatment with at least 1 time point post-dose with at minimum triplicate measures giving rise to a QTc value for primary correction method. Effect of moxifloxacin was as expected. Therefore, no analysis required per Medical Monitor.|||msec||90% Confidence Interval|Least Squares Mean
2631970|NCT01839279|Primary|The Primary Endpoint Will be the Baseline-adjusted, Placebo-corrected Effect on QTc (ΔΔQTc) on Day 14.|Change from baseline in Cardiac Repolarization (QTc Interval) at Day 14 (Tizanidine 24 mg). Moxifloxacin was not investigational drug, it was used to assess the sensitivity of the study.|Baseline and Day 14|QT/QTc Analysis set: Received at least 1 dose of study drug (including placebo), had measurements at baseline and on-treatment with at least 1 time point post-dose with at minimum triplicate measures giving rise to a QTc value for primary correction method. Effect of moxifloxacin was as expected. Therefore, no analysis required per Medical Monitor.|||milliseconds (msec)||90% Confidence Interval|Least Squares Mean
2631971|NCT01839188|Secondary|Number of Participants Experiencing a Serious Adverse Event (SAE)|An SAE is an adverse event (AE) that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially require medical or surgical intervention.|Up to ~6 months (at any time during the study)|All participants receiving ≥1 dose of study vaccination.|||Participants|||Count of Participants
2631972|NCT01839188|Secondary|Number of Participants Experiencing an Unsolicited Systemic Adverse Event (AE)|The number of participants experiencing unsolicited systemic AEs was assessed. Data are presented for the number of participants experiencing unsolicited AEs up to Day 15 after each vaccination and after any vaccination.|Up to Day 15 following each vaccination|All participants receiving ≥1 dose of any vaccination with corresponding safety follow-up data after each vaccination (for V1, V2, and V3 arms) and after any vaccination (for overall V1; V2; V3 arm).|||Participants|||Count of Participants
2631973|NCT01839188|Secondary|Number of Participants Experiencing a Solicited Systemic Adverse Event (AE)|The number of participants experiencing solicited systemic AEs (crying, decreased appetite, irritability, somnolence, pyrexia, and vomiting) was assessed. Each day from Day 1 to Day 5 following each vaccination, the participant's parent(s)/legal representative recorded all solicited AEs on the VRC. Data are presented for the number of participants experiencing solicited AEs up to Day 5 after each vaccination and after any vaccination.|Up to Day 5 following each vaccination|All participants receiving ≥1 dose of any vaccination with corresponding safety follow-up data after each vaccination (for V1, V2, and V3 arms) and after any vaccination (for overall V1; V2; V3 arm).|||Participants|||Count of Participants
2631974|NCT01839188|Secondary|Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination|The number of participants experiencing unsolicited ISRs related to the NeisVac-C® (MCC) vaccination was assessed. Unsolicited ISRs occurring at the NeisVac-C® (MCC) injection site were always considered related to the NeisVac-C® (MCC) vaccine. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing unsolicited ISRs up to Day 15 after each NeisVac-C® vaccination and after any NeisVac-C® vaccination.|Up to Day 15 following each vaccination|All participants receiving ≥1 dose of NeisVac-C® vaccination with corresponding safety follow-up data after each vaccination (for V1 and V2 arms) and after any vaccination (for V1; V2 arm) with NeisVac-C®.|||Participants|||Count of Participants
2631975|NCT01839188|Secondary|Number of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination|The number of participants experiencing unsolicited ISRs related to the PRI5 or Pediacel® vaccination was assessed. Unsolicited ISRs occurring at the PR5I or Pediacel® injection site were always considered related to the PR5I or Pediacel® vaccine, respectively. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing unsolicited ISRs up to Day 15 after each vaccination and after any vaccination.|Up to Day 15 following each vaccination|All participants receiving ≥1 dose of PR5I/Pediacel® vaccination with corresponding safety follow-up data after each vaccination (for V1, V2, and V3 arms) and after any vaccination (for overall V1; V2; V3 arm) with PR5I/Pediacel®.|||Participants|||Count of Participants
2631976|NCT01839188|Secondary|Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the NeisVac-C® (MCC) Vaccination|The number of participants experiencing solicited ISRs related to the NeisVac-C® (MCC) vaccination was assessed. Solicited ISRs (erythema, pain and swelling) occurring at the NeisVac-C® (MCC) injection site were always considered related to the NeisVac-C® (MCC) vaccine. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing solicited ISRs up to Day 5 after each NeisVac-C® vaccination and after any NeisVac-C® vaccination.|Up to Day 5 following each vaccination|All participants receiving ≥1 dose of NeisVac-C® vaccination with corresponding safety follow-up data after each vaccination (for V1 and V2 arms) and after any vaccination (for V1; V2 arm) with NeisVac-C®.|||Participants|||Count of Participants
2632019|NCT01838863|Other Pre-specified|Haemoglobin (Hb) Level|Haemoglobin (Hb) level in g/dL units.|Hospital stay up to 28 days.||||g/dL||Inter-Quartile Range|Median
2632020|NCT01838863|Other Pre-specified|Time to Admission and First Blood Transfusion in a Sub-group With Severe Hemorrhagic Shock|Time to Admission and First Blood Transfusion in the patients with initial systolic blood pressure (SBP) <=70 mmHg|Hospital stay up to 28 days.|Not all the timepoints are available for all the patients.|||minutes||Inter-Quartile Range|Median
2631977|NCT01839188|Secondary|Number of Participants Experiencing a Solicited Injection Site Reaction (ISR) Related to the PR5I/Pediacel® Vaccination|The number of participants experiencing solicited ISRs related to the PRI5 or Pediacel® vaccination was assessed. Solicited ISRs (erythema, pain and swelling) occurring at the PR5I or Pediacel® injection site were always considered related to the PR5I or Pediacel® vaccine, respectively. All AEs/ISRs were recorded on the VRC by the participant's parent(s)/legal representative. Data are presented for the number of participants experiencing solicited ISRs up to Day 5 after each vaccination and after any vaccination.|Up to Day 5 following each vaccination|All participants receiving ≥1 dose of PR5I/Pediacel® vaccination with corresponding safety follow-up data after each vaccination (for V1, V2, and V3 arms) and after any vaccination (for overall V1; V2; V3 arm) with PR5I/Pediacel®.|||Participants|||Count of Participants
2631978|NCT01839188|Secondary|Percentage of Participants With a Body Temperature ≥38°C After Each Vaccination|The percentage of participants with a body temperature ≥38.0°C from Day 1 to Day 5 after each vaccination was assessed. Per protocol, the participant's parent(s)/legal representative recorded daily body temperature measurements each evening by the axillary route (N=3 collected via rectal route; N=1 collected via oral route) and recorded these observations on the Vaccine Report Card (VRC). Temperatures were based on actual temperatures recorded with no adjustments for the route of assessment.|Up to Day 5 following each vaccination|All participants receiving ≥1 dose of any vaccination with corresponding safety follow-up data, having available body temperature data.|||Percentage of Participants|||Number
2631979|NCT01839188|Secondary|Percentage of Participants With an Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibody Titer ≥8|The percentage of participants with an anti-MCC antibody titer ≥8 was assessed. Participant serum samples were collected and analyzed for anti-MCC antibodies with the Serum Bactericidal Antibody assay using rabbit complement (rSBA).|Month 3 (one month after receiving Vaccination 2)|All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.|||Percentage of Participants||95% Confidence Interval|Number
2631980|NCT01839188|Secondary|Geometric Mean Titer of Anti-Meningococcal Group C Polysaccharide Conjugate (MCC) Antibodies|Participant serum samples were collected to determine the geometric mean titer of anti-MCC antibodies, measured by the Serum Bactericidal Antibody assay using rabbit complement (rSBA). The unit of measure is titer, expressed as the reciprocal of the final serum dilution giving ≥50% killing of the challenge bacterial strain.|Month 3 (one month after receiving Vaccination 2)|All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.|||Titer||95% Confidence Interval|Geometric Mean
2631981|NCT01839188|Secondary|Percentage of Participants Responding to Polyribosylribitol Phosphate (PRP) Antigen, Diptheria Toxin (D), Tetanus Toxin (T), and Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3)|"Participants were considered as responding if the observed concentration or titer for antibodies (Abs) to specific antigens exceeded the following thresholds:~For anti-PRP Abs (Hib capsular polysaccharide) - Response defined as a concentration ≥1 µg/mL (measured by RIA);~For anti-D Abs - Response defined at 2 concentrations: ≥0.01 IU/mL and ≥0.10 IU/mL (measured by MIT);~For anti-T Abs - Response defined at 2 concentrations: ≥0.01 IU/mL and ≥0.10 IU/mL (measured by ELISA);~For anti-IPV1, anti-IPV2, and anti-IPV3 Abs - Response defined as a titer ≥ 8 (measured by MIT).~The percentage of participants considered as responding to the individual antigen (per the response threshold[s]) were assessed."|Month 5 (one month after receiving Vaccination 3)|All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.|||Percentage of Participants||95% Confidence Interval|Number
2631982|NCT01839188|Secondary|Geometric Mean Titers for Antibodies to Inactivated Poliovirus 1-3 (IPV1-3)|Participant serum samples were collected for analysis with a Micrometabolic Inhibition Test (MIT) to determine the geometric mean titer of neutralizing antibodies (Abs) to Inactivated Poliovirus 1, 2, & 3 (IPV1, IPV2, & IPV3). The unit of measure is titer, expressed as the reciprocal dilution of the highest dilution that neutralizes 50% of the challenge virus.|Month 5 (one month after receiving Vaccination 3)|All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.|||Titer||95% Confidence Interval|Geometric Mean
2631983|NCT01839188|Secondary|Geometric Mean Concentrations of Antibodies to Pertussis Antigens|Participant serum samples were collected for analysis by ELISA to determine the geometric mean concentration of antibodies (Abs) to the following Pertussis antigens: pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN) and fimbriae types (FIM) 2&3. The unit of measure is ELISA Units/mL (EU/mL).|Month 5 (one month after receiving Vaccination 3)|All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.|||EU/mL||95% Confidence Interval|Geometric Mean
2631984|NCT01839188|Secondary|Geometric Mean Concentration of Antibodies to Tetanus Toxin|Participant serum samples were collected for analysis by Enzyme-linked Immunosorbent Assay (ELISA) to determine the geometric mean concentration of antibodies to tetanus toxin. The unit of measure is International Units/mL (IU/mL).|Month 5 (one month after receiving Vaccination 3)|All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.|||IU/mL||95% Confidence Interval|Geometric Mean
2631985|NCT01839188|Secondary|Geometric Mean Concentration of Antibodies to Diphtheria Toxin|Participant serum samples were collected for analysis with a Micrometabolic Inhibition Test (MIT) to determine the geometric mean concentration of neutralizing antibodies to diphtheria toxin. The unit of measure is International Units/mL (IU/mL).|Month 5 (one month after receiving Vaccination 3)|All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.|||IU/mL||95% Confidence Interval|Geometric Mean
2632021|NCT01838863|Other Pre-specified|Blood Product Transfusion in a Sub-group With Severe Hemorrhagic Shock|Number of blood products transfused in units in the patients with initial systolic blood pressure (SBP) <=70 mmHg|Hospital stay up to 28 days.|Not all the timepoints are available for all the patients.|||units||Inter-Quartile Range|Median
2631986|NCT01839188|Secondary|Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate (PRP) Antigen|Participant serum samples were collected for analysis by radioimmunoassay (RIA) to determine the geometric mean concentration of antibodies to polyribosylribitol phosphate (PRP), a Haemophilus influenzae type b (Hib) capsular polysaccharide.|Month 5 (one month after receiving Vaccination 3)|All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.|||μg/mL||95% Confidence Interval|Geometric Mean
2631987|NCT01839188|Secondary|Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen (HBsAg)|Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the geometric mean concentration of antibodies to Hepatitis B Surface Antigen (HBsAg). The unit of measure is milli International Units/mL (mIU/mL).|Month 5 (one month after receiving Vaccination 3)|All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.|||mIU/mL||95% Confidence Interval|Geometric Mean
2631988|NCT01839188|Primary|Percentage of Participants With an Anti-Polyribosylribitol Phosphate (PRP) Antibody Titer ≥0.15 µg/mL|The percentage of participants with an anti-Polyribosylribitol Phosphate (PRP) antibody titer ≥0.15 µg/mL was assessed. Participant serum samples were collected for analysis by radioimmunoassay to determine the concentration of antibodies to PRP, a Haemophilus influenzae type b (Hib) capsular polysaccharide.|Month 5 (one month after receiving Vaccination 3)|All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.|||Percentage of Participants||95% Confidence Interval|Number
2631989|NCT01839188|Primary|Percentage of Participants With an Anti-Hepatitis B Surface Antigen (HBsAg) Antibody Titer ≥10 mIU/mL|The percentage of participants with an anti-HBsAg antibody titer ≥10 mill-International Units/mL (mIU/mL) was assessed. Participant serum samples were collected for analysis with an enhanced chemiluminescence assay to determine the concentration of antibodies to HBsAg.|Month 5 (one month after receiving Vaccination 3)|All participants receiving ≥1 dose of study vaccination without protocol deviation, having post-vaccination immunogenicity data available for the evaluation of the respective analysis endpoint.|||Percentage of Participants||95% Confidence Interval|Number
2631990|NCT01839110|Primary|Changes in Right Ventricular Ejection Fraction|right ventricular ejection fraction by cardiac MRI|6 months|Completers|||percentage||Standard Error|Least Squares Mean
2631991|NCT01839058|Secondary|Number of Participants for Whom a Correlation Was Found Between Symptom Onset and Esophageal Shortening|Esophageal shortening will be defined as the point during the 20 minute acid infusion at which the lower esophageal sphincter begins to migrate proximally. A 2 minute window following this time point will then be used to determine if patients symptoms increased by > 2 on a visual analogue pain scale between 0 - 10.|20 minutes||||Participants|||Count of Participants
2631992|NCT01839058|Secondary|Esophageal Length at Maximal Symptom Intensity|Mean length of esophagus at peak patient reported symptom intensity with acid infusion|20 minutes|Data Not collected given lack of correlation between symptoms and esophageal length.||||||
2631993|NCT01839058|Secondary|Esophageal Length at Symptom Onset|Length of Esophagus as measured by manometry during acid infusion when patient reports symptoms|20 minutes|As pre-specified in the protocol, this Outcome Measure was intended to be analyzed only if a correlation was found between esophageal shortening and symptom production. Thus data was not collected.||||||
2631994|NCT01839058|Primary|Mean Change in Esophageal Length With Acid|Mean length of esophagus with acid infusion minus mean length of esophagus with saline infusion|Length at T= 20 minutes - Baseline (T=0)||||centimeters||Standard Deviation|Mean
2631995|NCT01838980|Primary|Mean of All Subjects Colon Segments BBPS>=2|"Human colon has 3 segments and each segment can be scored 0 (unprepared colon) - 3 (clean colon).~Summing all colon segments BBPS score of all participants dividing in the number of segments is expected to be >=2."|Following the colonoscopic procedure- Up to 24 hours.|"15 subjects were enrolled to the study.~1 was excluded. Total of 14 subjects were analyzed."|||Mean of BBPS score per segment||Standard Deviation|Mean
2631996|NCT01838941|Secondary|Developmental Status|Denver Developmental Screening Test expressed in years and months.|6 months|The Denver Developmental Screening Test was not performed.||||||
2631997|NCT01838941|Primary|Peroxisome Biochemical Functions as Measured by Plasma Very Long Chain Fatty Acid|C26/C22 ratio in plasma is a recognized biomarker for very long chain fatty acid (normal range: 0.002-0.018). It was measured twice before the beginning of treatment and measured once at the end.|6 months||||ratio||Full Range|Mean
2631998|NCT01838876|Primary|Change From Baseline in the Arizona Sexual Experiences Scale (ASEX) Score|The ASEX is a participant-completed scale to evaluate overall sexual experiences over the previous 7 days consisting of 5 questions answered on a scale of 1 (best) to 6 (worst) for a total possible score of 3 to 30 (2 questions were only answered if the participant was sexually active in the past week), higher score indicates greater sexual dysfunction. There are different forms for males and females. A negative change from Baseline indicates improvement.|Baseline (Lead-in study Baseline for roll-over participants and prior to first dose of this study for new participants) to End of Treatment (Up to Week 26) in this study|Participants from the Safety Population, all participants in the enrolled population who took at least 1 dose of cariprazine in this study, with data available for analysis at the given time-point.|||score on a scale||Standard Deviation|Mean
2631999|NCT01838876|Primary|Number of Participants With Treatment-Emergent Ocular Events|A TEAE is an AE that occurs or worsens after receiving study drug. Ocular events are adverse events related to the eye.|First dose of study drug to last dose of study drug in the 26-week Treatment Period plus a 2-week Safety Follow-up Period or within 30 days of last dose of study drug for participants who did not participate in the Safety Follow-up Period (Up to 30 weeks)|Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.|||Participants|||Count of Participants
2632022|NCT01838863|Other Pre-specified|Haemoglobin (Hb) Level in a Sub-group With Severe Hemorrhagic Shock|Haemoglobin (Hb) level in the patients with initial systolic blood pressure (SBP) <=70 mmHg|Hospital stay up to 28 days.|Not all the timepoints are available for all the patients.|||g/dL||Inter-Quartile Range|Median
2632023|NCT01838863|Other Pre-specified|Severe Adverse Events (SAE)|Number of participants with severe adverse events (SAE)|Hospital stay up to day 28||||Participants|||Count of Participants
2632000|NCT01838876|Primary|Number of Participants in the Most Severe Suicidal Ideation and Suicidal Behavior Recorded on the C-SSRS During the Treatment Period|The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead) to 5 (active suicidal ideation with specific plan and intent). The C-SSRS also captures information about the intensity of ideation, specifically the frequency, duration, controllability, deterrents, and reasons for the most severe types of ideation. Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior to 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes.|Baseline (Lead-in study Baseline for roll-over participants and prior to first dose in this study for new participants) to Week 26 in this study|Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.|||participants|||Number
2632001|NCT01838876|Primary|Number of Participants With Extrapyramidal Symptom (EPS)-Related TEAEs|Extrapyramidal symptoms are drug-induced movement disorders such as dystonia, akathisia, parkinsonism, bradykinesia, tremor, and tardive dyskinesia.|First dose of study drug to last dose of study drug in the 26-week Treatment Period plus a 2-week Safety Follow-up Period or within 30 days of last dose of study drug for participants who did not participate in the Safety Follow-up Period (Up to 30 weeks)|Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.|||Participants|||Count of Participants
2632002|NCT01838876|Primary|Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)|A standard 12-lead ECG was performed. The investigator determined the clinical significance of the ECG findings using the central ECG interpretation laboratory report.|Baseline (Week 0) to up to 26 weeks|Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.|||Participants|||Count of Participants
2632003|NCT01838876|Primary|Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters|Vital sign parameters included blood pressure, pulse rate, body mass index (BMI), weight, and waist circumference. The investigator assessed the results for clinical significance.|Baseline (Week 0) to up to 26 weeks in the Treatment Period plus a 2-week Safety Follow-up Period (Up to 28 weeks)|Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.|||Participants|||Count of Participants
2632004|NCT01838876|Primary|Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters|Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator assessed the results for clinical significance.|Baseline (Week 0) to up to 26 weeks in the Treatment Period|Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.|||Participants|||Count of Participants
2632005|NCT01838876|Primary|Number of Participants With Newly Emergent Adverse Events (NEAEs) in the Safety Follow-up Period|An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A NEAE is a new AE that occurred during the 2-week Safety Follow-up Period.|2 weeks following the 26-week Treatment Period|Participants in the Safety Population, all participants in the enrolled population who took at least 1 dose of cariprazine in this study, who entered the Safety Follow-up period.|||Participants|||Count of Participants
2632006|NCT01838876|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period|An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (i.e. laboratory value), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug.|First dose of study drug to last dose of study drug in the 26-week Treatment Period and within 30 days of last dose of study drug for participants who did not participate in the 2-week Safety Follow-up Period (Up to 30 weeks)|Safety Population included all participants in the enrolled population who took at least 1 dose of cariprazine in this study.|||Participants|||Count of Participants
2632007|NCT01838863|Post-Hoc|Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) clot lysis 30 minutes after the maximal amplitude (MA) was finalized.|post-intervention and upon ED arrival||||percentage of clot lysed at 30 minutes||Inter-Quartile Range|Median
2632008|NCT01838863|Post-Hoc|Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) clot strength measures by G value in kilodynes per square centimetre (kdyn/cm^2).|post-intervention and upon ED arrival||||kdyn/cm^2||Inter-Quartile Range|Median
2632009|NCT01838863|Post-Hoc|Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) maximal amplitude (MA).|post-intervention and upon ED arrival||||millimeter (mm)||Inter-Quartile Range|Median
2632010|NCT01838863|Post-Hoc|Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) angle measured in degrees.|post-intervention and upon ED arrival||||degree||Inter-Quartile Range|Median
2632011|NCT01838863|Post-Hoc|Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG). Percentage of clot lysis 30 minutes after maximal amplitude (MA) value is finalized.|after injury and prior to hospital arrival, at about 15 minutes after injury||||percentage of clot lysed at 30 minutes||Inter-Quartile Range|Median
2632012|NCT01838863|Post-Hoc|Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.|Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG). Clot strength measured in kilodynes per square centimetre (kdyn/cm^2).|after injury and prior to hospital arrival, at about 15 minutes after injury||||kdyn/cm^2||Inter-Quartile Range|Median
2632025|NCT01838863|Other Pre-specified|Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI)|Number of participants with mortality, adverse outcome-free days and transfusions in the patients with no severe traumatic brain injury (TBI) is defined as Abbreviated Injury Score (AIS) for Head/Neck >=3.|Hospital stay up to 28 days.||||Participants|||Count of Participants
2632026|NCT01838863|Other Pre-specified|Number of Adverse Outcome Free Days in a Sub-group With Severe Hemorrhagic Shock|Adverse outcome-free days in the patients with initial systolic blood pressure (SBP) <=70 mmHg|Hospital stay up to 28 days.|Not all the timepoints are available for all the patients.|||days||Inter-Quartile Range|Median
2632027|NCT01838863|Other Pre-specified|Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock|Mortality, adverse outcome-free days and transfusions in the patients with initial systolic blood pressure (SBP) <=70 mmHg|Hospital stay up to 28 days.||||Participants|||Count of Participants
2632028|NCT01838863|Other Pre-specified|Time to Admission and First Blood Transfusion in a Sub-group With Less Severe Hemorrhagic Shock|Time to Admission and First Blood Transfusion in minutes in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater|Hospital stay up to 28 days.||||minutes||Inter-Quartile Range|Median
2632029|NCT01838863|Other Pre-specified|Blood Product Transfusion in a Sub-group With Less Severe Hemorrhagic Shock|Transfusions of blood products in units in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater|Hospital stay up to 28 days.||||units||Inter-Quartile Range|Median
2632030|NCT01838863|Other Pre-specified|Level of Haemoglobin (Hb) in a Sub-group With Less Severe Hemorrhagic Shock|Level of Haemoglobin (Hb) in g/dL in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater|Hospital stay up to 28 days.||||g/dL||Inter-Quartile Range|Median
2632031|NCT01838863|Other Pre-specified|Adverse Outcome-free Days in a Sub-group With Less Severe Hemorrhagic Shock|Adverse outcome-free days in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater|Hospital stay up to 28 days.||||days||Inter-Quartile Range|Median
2632032|NCT01838863|Other Pre-specified|Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock|Mortality, adverse outcome-free days and transfusions in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater|Hospital stay up to 28 days.||||Participants|||Count of Participants
2632033|NCT01838863|Other Pre-specified|Exploratory Analyses.|Adverse outcome free days|Hospital stay up to 28 days.||||days||Inter-Quartile Range|Median
2632034|NCT01838863|Other Pre-specified|Exploratory Analyses|Number of participants with 24-hour mortality, adverse outcome free days and transfusions|Hospital stay up to 28 days.||||Participants|||Count of Participants
2632035|NCT01838863|Other Pre-specified|Number of Participants With Abnormal Admission Coagulation Factor XIII (Fibrin-stabilizing Factor) Level|defined as the first abnormal factor XIII (fibrin-stabilizing factor) level obtained upon ED arrival|within 30 minutes of Emergency Department (ED) arrival||||Participants|||Count of Participants
2632036|NCT01838863|Other Pre-specified|Admission (First Arrival) Coagulation Factor Levels|"defined as the first coagulation factor level obtained upon ED arrival~Coagulation Factor Reference Ranges~F2 F5 F7 F8 F9 F11~% % % % % % 67.0 - 107.0 63.0 - 116.0 52.0 - 120.0 58.0 - 132.0 47.0 - 122.0 52.0 - 120.0"|after injury prior to hospital arrival|Not all the timepoints are available for all the patients.|||percentage of activity||Inter-Quartile Range|Median
2632037|NCT01838863|Other Pre-specified|Number of Participants With Abnormal Baseline (Field) Coagulation Factor XIII Level|defined as abnormal coagulation factor XIII level obtained in the field prior to intervention|after injury prior to hospital arrival||||Participants|||Count of Participants
2632038|NCT01838863|Other Pre-specified|Baseline (Field) Coagulation Factor Levels|"defined as the first coagulation factor level obtained in the field prior to intervention~Coagulation Factor Reference Ranges~F2 F5 F7 F8 F9 F11~% % % % % % 67.0 - 107.0 63.0 - 116.0 52.0 - 120.0 58.0 - 132.0 47.0 - 122.0 52.0 - 120.0"|after injury and prior to hospital arrival, at about 15 minutes after injury||||percentage of activity||Inter-Quartile Range|Median
2632039|NCT01838863|Secondary|Number of Participants With Admission Severe Acidosis|Admission severe acidosis will be defined by base deficit (BD>10) upon ED arrival.|within 30 minutes of ED arrival||||Participants|||Count of Participants
2632040|NCT01838863|Secondary|Admission Acidosis|Admission acidosis will be defined by base deficit (BD) upon ED arrival.|within 30 minutes of ED arrival||||mEq/L||Inter-Quartile Range|Median
2632041|NCT01838863|Secondary|Number of Participants With Admission Severe Acidosis|Admission severe acidosis measured by lactate>5 upon ED arrival.|within 30 minutes of ED arrival||||Participants|||Count of Participants
2632042|NCT01838863|Secondary|Admission Acidosis|Admission acidosis measured by lactate upon ED arrival.|within 30 minutes of ED arrival||||mmol/L||Inter-Quartile Range|Median
2632043|NCT01838863|Secondary|Admission Clot Strength|Admission clot strength will be measured by thrombelastography G-value upon ED arrival. Clot strength measured in kilodynes per square centimetre (kdyn/cm^2).|within 30 minutes of ED arrival||||kdyne/cm^2||Inter-Quartile Range|Median
2632044|NCT01838863|Secondary|Number of Participants With Admission Severe Coagulopathy|Defined as international normalized ratio (INR) >1.3 obtained upon ED arrival. The international normalized ratio (INR) is an international standard for the prothrombin time (PT). This measures the time it takes for blood to clot. The normal range for a healthy person is 0.83-1.19. Usually, a high INR indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.|within 30 minutes of Emergency Department (ED) arrival||||Participants|||Count of Participants
2632045|NCT01838863|Secondary|Admission Coagulopathy|Defined as the first international normalized ratio (INR) obtained upon ED arrival. The international normalized ratio (INR) is an international standard for the prothrombin time (PT). This measures the time it takes for blood to clot. The normal range for a healthy person is 0.83-1.19. Usually, a high INR indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.|within 30 minutes of Emergency Department (ED) arrival||||ratio||Inter-Quartile Range|Median
2632076|NCT01838655|Secondary|Qualitative Change in Fundus Pigmentation at 12 Months Compared to Previous Visit.|Qualitative change in fundus pigmentation was measured as a binary endpoint (no change vs. increase) at Month 12 compared to Month 9|9 Months and 12 months||||Participants|||Count of Participants
2632046|NCT01838863|Secondary|Composite Outcome of 28-day In-hospital Mortality and Postinjury Multiple Organ Failure (MOF) Incidence|The occurrence of in-hospital death or MOF within the first 28 days postinjury. MOF is defined using the validated Denver MOF score (Denver MOF score>3 of simultaneously obtained scores after 48 hours postinjury).|28 days||||Participants|||Count of Participants
2632047|NCT01838863|Primary|Number of Participants That Died Within 28 Days Post Injury|death within 28 days post injury (death of any cause except for death due to a second, clearly unrelated traumatic injury suffered after discharge)|28 days||||Participants|||Count of Participants
2632048|NCT01838785|Secondary|The Test/Retest 18F-DTBZ PET Measurements of VMAT2 Binding in Healthy Subjects.||two years|A subgroup of 5 subjects receive additional scan for a test/retest reliability study|||SUVR||80% Confidence Interval|Mean
2632049|NCT01838785|Primary|Age-Dependent Change in Striatal 18F-DTBZ Uptake of Healthy Subjects.||two years||||SUVR||95% Confidence Interval|Mean
2632050|NCT01838694|Primary|Change From Baseline Serum Interleukin 6 (IL-6) Levels at the End of Active Dosing, Comparing Treatment to Placebo Cohort.||4 weeks|Analysis Population reflects participants for whom adequate analyzable samples were collected|||percentage change from baseline||Standard Deviation|Mean
2632051|NCT01838681|Secondary|Change From Randomisation to Week 24 in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q (SF)) Total Score During the Randomised Treatment Period|The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. The Q-LES-Q short form (SF) contains 16 items from the general activities section. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good). The total score is the sum of the first 14 items. The last two scores are stand-alone items. The total score ranges from 14 to 70.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||units on a scale||Standard Error|Least Squares Mean
2632052|NCT01838681|Secondary|Change From Randomisation to Week 6 in Q-LES-Q (SF) Total Score During the Randomised Treatment Period|The original Q-LES-Q is a patient self-rated scale designed to measure the degree of enjoyment and satisfaction experienced by patients in various areas of daily life. It consists of 93 items to measure: physical health, feelings, work, household duties, school, leisure time activities, social relations, and general activities. The Q-LES-Q short form (SF) contains 16 items from the general activities section. Each item is rated on a 5-point scale ranging from 1 (very poor) to 5 (very good). The total score is the sum of the first 14 items. The last two scores are stand-alone items. The total score ranges from 14 to 70.|From randomisation to week 6|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||units on a scale||Standard Error|Least Squares Mean
2632053|NCT01838681|Secondary|Change From Randomisation to Week 24 in CGI-S Score During the Randomised Treatment Period|The CGI-S is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||units on a scale||Standard Error|Least Squares Mean
2632054|NCT01838681|Secondary|Change From Randomisation to Week 6 in CGI-S Score During the Randomised Treatment Period|The CGI-S is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|From randomisation to week 6|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||units on a scale||Standard Error|Least Squares Mean
2632055|NCT01838681|Secondary|Change From Randomisation to Week 24 in SDS Total Score During the Randomised Treatment Period|The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||units on a scale||Standard Error|Least Squares Mean
2632056|NCT01838681|Secondary|Change From Randomisation to Week 6 in SDS Total Score During the Randomised Treatment Period|The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.|From randomisation to week 6|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B|||units on a scale||Standard Error|Least Squares Mean
2632057|NCT01838681|Secondary|Remission at Week 24 in the Randomised Treatment Period|Remission is defined as a MADRS total score <=10 and a >=50% decrease from randomisation in MADRS total score.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. Last Observation Carried Forward (LOCF).|||participants|||Number
2632058|NCT01838681|Secondary|Remission at Week 6 During the Randomised Treatment Period|Remission is defined as a MADRS total score <=10 and a >=50% decrease from randomisation in MADRS total score.|From randomisation to week 6|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. Last Observation Carried Forward (LOCF).|||participants|||Number
2632059|NCT01838681|Secondary|Response at Week 24 During the Randomised Treatment Period|Response is defined as a >=50% decrease from randomisation in MADRS total score.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. Last Observation Carried Forward (LOCF).|||participants|||Number
2632060|NCT01838681|Secondary|Response at Week 6 During the Randomised Treatment Period|Response is defined as a >=50% decrease from randomisation in MADRS total score.|From randomisation to week 6|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B. Last Observation Carried Forward (LOCF).|||participants|||Number
2632061|NCT01838681|Secondary|Change From Randomisation to Week 24 in MADRS Total Score During the Randomised Treatment Period|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||Units on a scale||Standard Error|Least Squares Mean
2632062|NCT01838681|Secondary|Change From Randomisation to Week 6 in MADRS Total Score During the Randomised Treatment Period|The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items.|From randomisation to week 6|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||units on a scale||Standard Error|Least Squares Mean
2632063|NCT01838681|Secondary|Full Remission Sustained During the Randomised Treatment Period|Full remission sustained is defined as having obtained full remission and remain in remission until completion of the study. Full remission is defined as a MADRS total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomised treatment.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||participants|||Number
2632064|NCT01838681|Secondary|Time to Full Remission During the Randomised Treatment Period|The time from randomisation until full remission has been obtained. Full remission is defined as a MADRS total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomised treatment. The time to full remission was calculated using Kaplan-Meier Methods.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||Days||95% Confidence Interval|Median
2632065|NCT01838681|Secondary|Total Time in Remission During the Randomised Treatment Period|The total time the patient spends in remission during randomised treatment. Remission is defined as a MADRS total score <=10 and a >=50% decrease from randomisation in MADRS total score. Time in remission is defined as the sum of days over all periods between Period B visits where remission was obtained. The period between two visits is counted as in remission if the patient was in remission when the period started.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||Number of days||Standard Deviation|Mean
2632066|NCT01838681|Secondary|Full Global Score Remission During the Randomised Treatment Period|Full global score remission is defined as a Clinical Global Impression - Severity of Illness (CGI-S) score <=2 observed for at least 8 consecutive weeks during the randomised treatment period. The CGI-S is a 7-point scale where the clinician rates the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis, on the following scale: 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||participants|||Number
2632067|NCT01838681|Secondary|Full Functional Remission During the Randomised Treatment Period|Full functional remission is defined as a Sheehan Disability Scale (SDS) total score <=6 and all SDS domain scores <=2 observed for at least 8 consecutive weeks during the randomised treatment period. The SDS assesses functional impairment in 3 domains: work/school, social life or leisure activities, and home life or family responsibilities. The participant rates the extent to which each aspect is impaired on a 10-point visual analog scale, from 0 (not at all) to 10 (extremely). The 3 scores are added together to calculate the total score, which ranges from 0 to 30, with higher scores indicating more impairment.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||participants|||Number
2632068|NCT01838681|Primary|Full Remission During the Randomised Treatment Period|Full remission is defined as a Montomery and Åsberg Depression Rating Scale (MADRS) total score ≤10 and a ≥50% decrease from randomisation in MADRS total score for at least 8 consecutive weeks during randomized treatment. The MADRS is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). The MADRS total score is the sum of the 10 items.|From randomisation to end of Period B (24 weeks)|All randomised patients who took at least one dose of randomised treatment (brexpiprazole or placebo) in Period B.|||participants|||Number
2632069|NCT01838655|Other Pre-specified|Number of Participants Withdrawn From Investigational Product (IP) Due to Safety and Abnormal Laboratory Results||Study duration, up to 18 months||||participant withdrawals|||Number
2632070|NCT01838655|Other Pre-specified|Number of Adverse Events Related to Investigational Product (IP)||Study duration, up to 18 months||||adverse events related to IP|||Number
2632071|NCT01838655|Other Pre-specified|Severity of Adverse Events||Study duration, up to 18 months||||adverse events|||Number
2632072|NCT01838655|Other Pre-specified|Number of Non-ocular Adverse Events||Study duration, up to 18 months||||non-ocular adverse events|||Number
2632073|NCT01838655|Other Pre-specified|Number of Ocular Adverse Events||Study duration, up to 18 months||||ocular adverse events|||Number
2632074|NCT01838655|Secondary|Percent Change in Hair Melanin at 12 Months Compared to Baseline|Hair melanin was assessed using pyrrole-2,3,5-tricarboxylic acid (PTCA), a marker of eumelanin and 4-amino-3-hydroxyphenylalanine (4-AHP), a marker of pheomelanin.|Baseline and 12 months||||percentage change||Standard Deviation|Mean
2632075|NCT01838655|Secondary|Absolute Change in Hair Melanin at 12 Months Compared to Baseline|Hair melanin was assessed using pyrrole-2,3,5-tricarboxylic acid (PTCA), a marker of eumelanin and 4-amino-3-hydroxyphenylalanine (4-AHP), a marker of pheomelanin.|Baseline and 12 months||||ng/mg||Standard Deviation|Mean
2632079|NCT01838655|Secondary|Qualitative Change in Fundus Pigmentation at 3 Months Compared to Previous Visit.|Qualitative change in fundus pigmentation was measured as a binary endpoint (no change vs. increase) at Month 3 compared to previous visit.|Baseline and 3 months||||Participants|||Count of Participants
2632080|NCT01838655|Secondary|Qualitative Change in Skin Pigmentation at 12 Months Compared to Previous Visit.|Qualitative change in skin pigmentation was measured as a binary endpoint (no change vs. increase) at Month 12 compared to Month 9|9 Months and 12 months||||Participants|||Count of Participants
2632081|NCT01838655|Secondary|Qualitative Change in Skin Pigmentation at 9 Months Compared to Previous Visit.|Qualitative change in skin pigmentation was measured as a binary endpoint (no change vs. increase) at Month 9 compared to Month 6|6 Months and 9 months||||Participants|||Count of Participants
2632082|NCT01838655|Secondary|Qualitative Change in Skin Pigmentation at 6 Months Compared to Previous Visit.|Qualitative change in skin pigmentation was measured as a binary endpoint (no change vs. increase) at Month 6 compared to Month 3|3 Months and 6 months||||Participants|||Count of Participants
2632083|NCT01838655|Secondary|Qualitative Change in Skin Pigmentation at 3 Months Compared to Previous Visit.|Qualitative change in skin pigmentation was measured as a binary endpoint (no change vs. increase) at Month 3 compared to previous visit.|Baseline and 3 months||||Participants|||Count of Participants
2632084|NCT01838655|Secondary|Qualitative Change in Hair Pigmentation at 12 Months Compared to Previous Visit.|Qualitative change in hair pigmentation was measured as a binary endpoint (no change vs. increase) at Month 12 compared to Month 9|9 Months and 12 months||||Participants|||Count of Participants
2632085|NCT01838655|Secondary|Qualitative Change in Hair Pigmentation at 9 Months Compared to Previous Visit.|Qualitative change in hair pigmentation was measured as a binary endpoint (no change vs. increase) at Month 9 compared to Month 6|6 Months and 9 months||||Participants|||Count of Participants
2632086|NCT01838655|Secondary|Qualitative Change in Hair Pigmentation at 6 Months Compared to Previous Visit.|Qualitative change in hair pigmentation was measured as a binary endpoint (no change vs. increase) at Month 6 compared to Month 3|3 Months and 6 months||||Participants|||Count of Participants
2632087|NCT01838655|Secondary|Qualitative Change in Hair Pigmentation at 3 Months Compared to Previous Visit.|Qualitative change in hair pigmentation was measured as a binary endpoint (no change vs. increase) at Month 3 compared to previous visit.|Baseline and 3 months||||Participants|||Count of Participants
2632088|NCT01838655|Secondary|Absolute Change in Electroretinogram (ERG) at Month 12 as Compared to Baseline.|Amplitude for the ERG parameter, Dark Adaptation (DA) Comb B, was measured at each visit. Participants left and right eye will be analyzed.|Baseline and 12 months|Right eyes (OD) and left eyes (OS)|||µV|eyes|Standard Deviation|Mean
2632089|NCT01838655|Secondary|Absolute Change in Electroretinogram (ERG) at Month 6 as Compared to Baseline.|Amplitude for the ERG parameter, Dark Adaptation (DA) Comb B, was measured at each visit. Participants left and right eye will be analyzed.|Baseline and 6 months|Right eyes (OD) and left eyes (OS)|||µV|eyes|Standard Deviation|Mean
2632090|NCT01838655|Secondary|Percent Change in Melanin Index at 12 Months Compared to Baseline|"Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object's reflectance to the maximum reflectance possible). Melanin (M) index was calculated as follows:~Eqn 1= [ (PR at 650nm + PR at 660nm + 0.5*PR at 640nm + 0.5*PR at 670nm)/3 ]/100; M index = 100*log (1/Eqn 1) Higher values of M index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites:forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Percent change from baseline was calculated using these mean values."|Baseline and 12 Months||||Percentage change||Standard Deviation|Mean
2632091|NCT01838655|Secondary|Percent Change in Melanin Index at 9 Months Compared to Baseline|"Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object's reflectance to the maximum reflectance possible). Melanin (M) index was calculated as follows:~Eqn 1= [ (PR at 650nm + PR at 660nm + 0.5*PR at 640nm + 0.5*PR at 670nm)/3 ]/100; M index = 100*log (1/Eqn 1) Higher values of M index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites:forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Percent change from baseline was calculated using these mean values."|Baseline and 9 Months|Participant 002 did not have skin reflectometry measurements for any site at Month 9.|||Percentage change||Standard Deviation|Mean
2632092|NCT01838655|Secondary|Percent Change in Melanin Index at 6 Months Compared to Baseline|"Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object's reflectance to the maximum reflectance possible). Melanin (M) index was calculated as follows:~Eqn 1= [ (PR at 650nm + PR at 660nm + 0.5*PR at 640nm + 0.5*PR at 670nm)/3 ]/100; M index = 100*log (1/Eqn 1) Higher values of M index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites:forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Percent change from baseline was calculated using these mean values."|Baseline and 6 Months|Participant 005 did not have skin reflectometry measurements for any site at Month 6.|||Percentage change||Standard Deviation|Mean
2632144|NCT01838616|Secondary|Sleep Evaluation at the End of Treatment: Change in Latency (Change in the Time Taken to Fall Asleep)|The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the visits. The negative change from baseline indicates that the time to falling asleep decreased from baseline in a treatment group.|Baseline (Randomization Visit); End of Continuation Visit (Week 12)|Full Analysis Set (FAS). Last Observation carried Forward (LOCF). Number of participants taken into account for the analyses.|||hours||Standard Error|Least Squares Mean
2632093|NCT01838655|Secondary|Percent Change in Melanin Index at 3 Months Compared to Baseline|"Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object's reflectance to the maximum reflectance possible). Melanin (M) index was calculated as follows:~Eqn 1= [ (PR at 650nm + PR at 660nm + 0.5*PR at 640nm + 0.5*PR at 670nm)/3 ]/100; M index = 100*log (1/Eqn 1) Higher values of M index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites:forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Percent change from baseline was calculated using these mean values."|Baseline and 3 Months||||Percentage change||Standard Deviation|Mean
2632094|NCT01838655|Secondary|Absolute Change in Melanin Index at 12 Months Compared to Baseline|"Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object's reflectance to the maximum reflectance possible). Melanin (M) index was calculated as follows:~Eqn 1= [ (PR at 650nm + PR at 660nm + 0.5*PR at 640nm + 0.5*PR at 670nm)/3 ]/100; M index = 100*log (1/Eqn 1) Higher values of M index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites:forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Absolute change from baseline was calculated using these mean values."|Baseline and 12 Months||||Melanin Index||Standard Deviation|Mean
2632095|NCT01838655|Secondary|Absolute Change in Melanin Index at 9 Months Compared to Baseline|"Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object's reflectance to the maximum reflectance possible). Melanin (M) index was calculated as follows:~Eqn 1= [ (PR at 650nm + PR at 660nm + 0.5*PR at 640nm + 0.5*PR at 670nm)/3 ]/100; M index = 100*log (1/Eqn 1) Higher values of M index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites:forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Absolute change from baseline was calculated using these mean values."|Baseline and 9 Months|Participant 002 did not have skin reflectometry measurements for any site at Month 9.|||Melanin Index||Standard Deviation|Mean
2632096|NCT01838655|Secondary|Absolute Change in Melanin Index at 6 Months Compared to Baseline|"Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object's reflectance to the maximum reflectance possible). Melanin (M) index was calculated as follows:~Eqn 1= [ (PR at 650nm + PR at 660nm + 0.5*PR at 640nm + 0.5*PR at 670nm)/3 ]/100; M index = 100*log (1/Eqn 1) Higher values of M index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites:forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Absolute change from baseline was calculated using these mean values."|Baseline and 6 Months|Participant 005 did not have skin reflectometry measurements for any site at Month 6.|||Melanin Index||Standard Deviation|Mean
2632097|NCT01838655|Secondary|Absolute Change in Melanin Index at 3 Months Compared to Baseline|"Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object's reflectance to the maximum reflectance possible). Melanin (M) index was calculated as follows:~Eqn 1= [ (PR at 650nm + PR at 660nm + 0.5*PR at 640nm + 0.5*PR at 670nm)/3 ]/100; M index = 100*log (1/Eqn 1) Higher values of M index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites:forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Absolute change from baseline was calculated using these mean values."|Baseline and 3 Months||||Melanin Index||Standard Deviation|Mean
2632098|NCT01838655|Secondary|Percent Change in Adjusted Melanin Index at 12 Months Compared to Baseline|Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object's reflectance to the maximum reflectance possible). Apparent absorbance (AA) at a given wavelength was determined as log10 (PR of blank/PR of object) at that wavelength. Adjusted Melanin (AM) index is calculated as the slope of AA levels from 650 to 700 nm. Lower values of AM index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites: forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Percent change from baseline was calculated using these mean values.|Baseline and 12 Months||||Percentage change||Standard Deviation|Mean
2632105|NCT01838655|Secondary|Absolute Change in Adjusted Melanin Index at 3 Months Compared to Baseline|Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object's reflectance to the maximum reflectance possible). Apparent absorbance (AA) at a given wavelength was determined as log10 (PR of blank/PR of object) at that wavelength. Adjusted Melanin (AM) index is calculated as the slope of AA levels from 650 to 700 nm. Lower values of AM index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites: forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Absolute change from baseline was calculated using these mean values.|Baseline and 3 Months||||Adjusted Melanin Index*10^-5||Standard Deviation|Mean
2632099|NCT01838655|Secondary|Percent Change in Adjusted Melanin Index at 9 Months Compared to Baseline|Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object's reflectance to the maximum reflectance possible). Apparent absorbance (AA) at a given wavelength was determined as log10 (PR of blank/PR of object) at that wavelength. Adjusted Melanin (AM) index is calculated as the slope of AA levels from 650 to 700 nm. Lower values of AM index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites: forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Percent change from baseline was calculated using these mean values.|Baseline and 9 Months|Participant 002 did not have skin reflectometry measurements for any site at Month 9.|||Percentage change||Standard Deviation|Mean
2632100|NCT01838655|Secondary|Percent Change in Adjusted Melanin Index at 6 Months Compared to Baseline|Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object's reflectance to the maximum reflectance possible). Apparent absorbance (AA) at a given wavelength was determined as log10 (PR of blank/PR of object) at that wavelength. Adjusted Melanin (AM) index is calculated as the slope of AA levels from 650 to 700 nm. Lower values of AM index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites: forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Percent change from baseline was calculated using these mean values.|Baseline and 6 Months|Participant 005 did not have skin reflectometry measurements for any site at Month 6.|||Percentage change||Standard Deviation|Mean
2632101|NCT01838655|Secondary|Percent Change in Adjusted Melanin Index at 3 Months Compared to Baseline|Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object's reflectance to the maximum reflectance possible). Apparent absorbance (AA) at a given wavelength was determined as log10 (PR of blank/PR of object) at that wavelength. Adjusted Melanin (AM) index is calculated as the slope of AA levels from 650 to 700 nm. Lower values of AM index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites: forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Percent change from baseline was calculated using these mean values.|Baseline and 3 Months||||Percentage change||Standard Deviation|Mean
2632102|NCT01838655|Secondary|Absolute Change in Adjusted Melanin Index at 12 Months Compared to Baseline|Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object's reflectance to the maximum reflectance possible). Apparent absorbance (AA) at a given wavelength was determined as log10 (PR of blank/PR of object) at that wavelength. Adjusted Melanin (AM) index is calculated as the slope of AA levels from 650 to 700 nm. Lower values of AM index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites: forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Absolute change from baseline was calculated using these mean values.|Baseline and 12 Months||||Adjusted Melanin Index*10^-5||Standard Deviation|Mean
2632103|NCT01838655|Secondary|Absolute Change in Adjusted Melanin Index at 9 Months Compared to Baseline|Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object's reflectance to the maximum reflectance possible). Apparent absorbance (AA) at a given wavelength was determined as log10 (PR of blank/PR of object) at that wavelength. Adjusted Melanin (AM) index is calculated as the slope of AA levels from 650 to 700 nm. Lower values of AM index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites: forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Absolute change from baseline was calculated using these mean values.|Baseline and 9 Months|Participant 002 did not have any skin reflectometry measurements for any site at Month 9.|||Adjusted Melanin Index*10^-5||Standard Deviation|Mean
2632104|NCT01838655|Secondary|Absolute Change in Adjusted Melanin Index at 6 Months Compared to Baseline|Microflash 200D is a diffuse reflectance spectrophotometer that uses a prism photodiode to provide information at 10 nm increments along the visual spectrum from 400 to 700 nm. Percent reflectance (PR) at a specific wavelength was placed into context by relating it to the reflectance of a blank at the equivalent wavelength (i.e. relating the object's reflectance to the maximum reflectance possible). Apparent absorbance (AA) at a given wavelength was determined as log10 (PR of blank/PR of object) at that wavelength. Adjusted Melanin (AM) index is calculated as the slope of AA levels from 650 to 700 nm. Lower values of AM index correspond to higher melanin concentrations. Measurements were collected 5 times at each visit from each of the following sites: forehead, inner forearm, outer forearm, inner bicep and lower back. The mean of these five measurements was calculated at each visit. Absolute change from baseline was calculated using these mean values.|Baseline and 6 Months|Participant 005 did not have skin reflectometry measurements for any site at Month 6.|||Adjusted Melanin Index*10^-5||Standard Deviation|Mean
2632120|NCT01838655|Secondary|Absolute Change in Electronic Visual Acuity at 6 Months Compared to Baseline|Visual acuity was measured using the Electronic ETDRS Visual Acuity Testing protocol. Acuity is measured as letters read using an electronic ETDRS program.|Baseline and 6 months|Right (OD) and Left (OS) eyes|||ETDRS letters|eyes|Standard Deviation|Mean
2633524|NCT01823679|Secondary|Overall Survival (OS) at 1 Year|Proportion of participants with overall survival (OS) at 1 year, as calculated based on Kaplan-Meier estimates.|1 year||||percentage of participants|||Number
2632106|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity With High Glare at 12 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. Minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity with high glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 12 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 12 months||||units||Standard Deviation|Mean
2632107|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity With High Glare at 9 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. Minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity with high glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 9 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 9 months||||units||Standard Deviation|Mean
2632108|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity With High Glare at 6 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. Minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity with high glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 6 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 6 months||||units||Standard Deviation|Mean
2632109|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity With High Glare at 3 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. Minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity with high glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 3 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 3 months||||units||Standard Deviation|Mean
2632110|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity With Medium Glare at 12 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. Minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity with medium glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 12 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 12 months||||units||Standard Deviation|Mean
2632111|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity With Medium Glare at 9 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. Minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity with medium glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 9 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 9 months||||units||Standard Deviation|Mean
2632121|NCT01838655|Secondary|Absolute Change in Electronic Visual Acuity at 3 Months Compared to Baseline|Visual acuity was measured using the Electronic ETDRS Visual Acuity Testing protocol. Acuity is measured as letters read using an electronic ETDRS program.|Baseline and 3 months|Right (OD) and Left (OS) eyes|||ETDRS letters|eyes|Standard Deviation|Mean
2632190|NCT01838304|Secondary|Decrease in Minute Ventilation From Baseline|Minute ventilation as determined by respiratory inductance plethysmography from initiation of sedation until emergence.|Duration of sedation (average of 25 minutes)||||percentage of baseline||97.5% Confidence Interval|Median
2632112|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity With Medium Glare at 6 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. Minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity with medium glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 6 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 6 months||||units||Standard Deviation|Mean
2632113|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity With Medium Glare at 3 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. Minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity with medium glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 3 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 3 months||||units||Standard Deviation|Mean
2632114|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity Without Glare at 12 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. The minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity without glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 12 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 12 months||||units||Standard Deviation|Mean
2632115|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity Without Glare at 9 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. The minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity without glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 9 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 9 months||||units||Standard Deviation|Mean
2632116|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity Without Glare at 6 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. The minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity without glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 6 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 6 months||||units||Standard Deviation|Mean
2632117|NCT01838655|Secondary|Absolute Change in Contrast Sensitivity Without Glare at 3 Months Compared to Baseline|Gratings, images with alternating light and dark bars, assess contrast sensitivity via spatial frequency and contrast. Spatial frequency (SF), the number of pairs of bars (1 light, 1 dark) imaged within a given distance of the retina, is measured as the number of cycles per degree (cpd) of visual angle, where a cycle is 1 pair of bars. Grating of high SF corresponds to narrow bars; grating of low SF corresponds to wide bars. Contrast is the intensity difference between light and dark bars. The minimum contrast required to detect a given SF is the threshold contrast. The lower the threshold contrast, higher the contrast sensitivity. Contrast sensitivity without glare was measured at frequencies of 1.5, 3, 6, 12, 18 cpd. Absolute change from baseline to 3 months was calculated. Raw values were used for the planned descriptive analysis; logarithmic transformation was not used as formal statistical analysis was not planned and was not appropriate as a majority of the raw values were 0.|Baseline and 3 months||||units||Standard Deviation|Mean
2632118|NCT01838655|Secondary|Absolute Change in Electronic Visual Acuity at 12 Months Compared to Baseline|Visual acuity was measured using the Electronic ETDRS Visual Acuity Testing protocol. Acuity is measured as letters read using an electronic ETDRS program.|Baseline and 12 months|Right (OD) and Left (OS) eyes|||ETDRS letters|eyes|Standard Deviation|Mean
2632119|NCT01838655|Secondary|Absolute Change in Electronic Visual Acuity at 9 Months Compared to Baseline|Visual acuity was measured using the Electronic ETDRS Visual Acuity Testing protocol. Acuity is measured as letters read using an electronic ETDRS program.|Baseline and 9 months|Right (OD) and Left (OS) eyes|||ETDRS letters|eyes|Standard Deviation|Mean
2632122|NCT01838655|Secondary|Percent Change in Semi-quantitative Iris Pigmentation for Each Eye at 12 Months as Compared to Baseline|In Adobe Photoshop 7.0 the high resolution slit lamp image was divided into 4 quadrants with vertical and horizontal lines transecting the center of the iris. Using the elliptical marquee tool, a circle, approximately 0.25 times the diameter of the iris, was drawn in the center of each quadrant. Gaussian blur with radius of 50 was applied to the area enclosed in the 4 circles. With the dropper tool, the red pigment value corresponding to the degree of iris transillumination was sampled at the center of each circle. The 4 values were averaged to yield a composite transillumination score for each subject. Quantified values were then correlated to a scale score from 1 to 8 to generate an 8-point iris transillumination scale, with lower scores reflective of greater iris pigmentation (melanin content). The mean score across the 2 images for each participant's eye was calculated at baseline and 12 months; these mean grades were then used to calculate percentage change from baseline.|Baseline and 12 months|Right (OD) and left (OS) eyes|||percentage change|eyes|Standard Deviation|Mean
2632123|NCT01838655|Secondary|Percent Change in Semi-quantitative Iris Pigmentation for Each Eye at 9 Months as Compared to Baseline|In Adobe Photoshop 7.0 the high resolution slit lamp image was divided into 4 quadrants with vertical and horizontal lines transecting the center of the iris. Using the elliptical marquee tool, a circle, approximately 0.25 times the diameter of the iris, was drawn in the center of each quadrant. Gaussian blur with radius of 50 was applied to the area enclosed in the 4 circles. With the dropper tool, the red pigment value corresponding to the degree of iris transillumination was sampled at the center of each circle. The 4 values were averaged to yield a composite transillumination score for each subject. Quantified values were then correlated to a scale score from 1 to 8 to generate an 8-point iris transillumination scale, with lower scores reflective of greater iris pigmentation (melanin content). The mean score across the 2 images for each participant's eye was calculated at baseline and 9 months; these mean grades were then used to calculate percentage change from baseline.|Baseline and 9 months|Right (OD) and left (OS) eyes|||percentage change|eyes|Standard Deviation|Mean
2632124|NCT01838655|Secondary|Percent Change in Semi-quantitative Iris Pigmentation for Each Eye at 6 Months as Compared to Baseline|In Adobe Photoshop 7.0 the high resolution slit lamp image was divided into 4 quadrants with vertical and horizontal lines transecting the center of the iris. Using the elliptical marquee tool, a circle, approximately 0.25 times the diameter of the iris, was drawn in the center of each quadrant. Gaussian blur with radius of 50 was applied to the area enclosed in the 4 circles. With the dropper tool, the red pigment value corresponding to the degree of iris transillumination was sampled at the center of each circle. The 4 values were averaged to yield a composite transillumination score for each subject. Quantified values were then correlated to a scale score from 1 to 8 to generate an 8-point iris transillumination scale, with lower scores reflective of greater iris pigmentation (melanin content). The mean score across the 2 images for each participant's eye was calculated at baseline and 6 months; these mean grades were then used to calculate percentage change from baseline.|Baseline and 6 months|Right (OD) and left (OS) eyes|||percentage change|eyes|Standard Deviation|Mean
2632125|NCT01838655|Secondary|Percent Change in Semi-quantitative Iris Pigmentation for Each Eye at 3 Months as Compared to Baseline|In Adobe Photoshop 7.0 the high resolution slit lamp image was divided into 4 quadrants with vertical and horizontal lines transecting the center of the iris. Using the elliptical marquee tool, a circle, approximately 0.25 times the diameter of the iris, was drawn in the center of each quadrant. Gaussian blur with radius of 50 was applied to the area enclosed in the 4 circles. With the dropper tool, the red pigment value corresponding to the degree of iris transillumination was sampled at the center of each circle. The 4 values were averaged to yield a composite transillumination score for each subject. Quantified values were then correlated to a scale score from 1 to 8 to generate an 8-point iris transillumination scale, with lower scores reflective of greater iris pigmentation (melanin content). The mean score across the 2 images for each participant's eye was calculated at baseline and 3 months; these mean grades were then used to calculate percentage change from baseline.|Baseline and 3 months|Right (OD) and left (OS) eyes|||percentage change|eyes|Standard Deviation|Mean
2632126|NCT01838655|Secondary|Absolute Change in Semi-quantitative Iris Pigmentation for Each Eye at 12 Months as Compared to Baseline|In Adobe Photoshop 7.0 the high resolution slit lamp image was divided into 4 quadrants with vertical and horizontal lines transecting the center of the iris. Using the elliptical marquee tool, a circle, approximately 0.25 times the diameter of the iris, was drawn in the center of each quadrant. Gaussian blur with radius of 50 was applied to the area enclosed in the 4 circles. With the dropper tool, the red pigment value corresponding to the degree of iris transillumination was sampled at the center of each circle. The 4 values were averaged to yield a composite transillumination score for each subject. Quantified values were then correlated to a scale score from 1 to 8 to generate an 8-point iris transillumination scale, with lower scores reflective of greater iris pigmentation (melanin content). The mean score across the 2 images for each participant's eye was calculated at baseline and 12 months; these mean grades were then used to calculate absolute change from baseline.|Baseline and 12 months|Right (OD) and left (OS) eyes|||scores on a scale|eyes|Standard Deviation|Mean
2632127|NCT01838655|Secondary|Absolute Change in Semi-quantitative Iris Pigmentation for Each Eye at 9 Months as Compared to Baseline|In Adobe Photoshop 7.0 the high resolution slit lamp image was divided into 4 quadrants with vertical and horizontal lines transecting the center of the iris. Using the elliptical marquee tool, a circle, approximately 0.25 times the diameter of the iris, was drawn in the center of each quadrant. Gaussian blur with radius of 50 was applied to the area enclosed in the 4 circles. With the dropper tool, the red pigment value corresponding to the degree of iris transillumination was sampled at the center of each circle. The 4 values were averaged to yield a composite transillumination score for each subject. Quantified values were then correlated to a scale score from 1 to 8 to generate an 8-point iris transillumination scale, with lower scores reflective of greater iris pigmentation (melanin content). The mean score across the 2 images for each participant's eye was calculated at baseline and 9 months; these mean grades were then used to calculate absolute change from baseline.|Baseline and 9 months|Right (OD) and left (OS) eyes|||scores on a scale|eyes|Standard Deviation|Mean
2632340|NCT01836042|Primary|Rate of Sight-threatening Adverse Events|The primary endpoint is the occurrence of sight-threatening adverse events. The rate of sight-threatening adverse events at each visit will be calculated for the three treatment groups (randomized control group, randomized iStent group, and non-randomized iStent group) separately. The summary will also be performed for pooling the randomized iStent and non-randomized iStent group.|80 Month average||||percentage of subjects|||Number
2632128|NCT01838655|Secondary|Absolute Change in Semi-quantitative Iris Pigmentation for Each Eye at 6 Months as Compared to Baseline|In Adobe Photoshop 7.0 the high resolution slit lamp image was divided into 4 quadrants with vertical and horizontal lines transecting the center of the iris. Using the elliptical marquee tool, a circle, approximately 0.25 times the diameter of the iris, was drawn in the center of each quadrant. Gaussian blur with radius of 50 was applied to the area enclosed in the 4 circles. With the dropper tool, the red pigment value corresponding to the degree of iris transillumination was sampled at the center of each circle. The 4 values were averaged to yield a composite transillumination score for each subject. Quantified values were then correlated to a scale score from 1 to 8 to generate an 8-point iris transillumination scale, with lower scores reflective of greater iris pigmentation (melanin content). The mean score across the 2 images for each participant's eye was calculated at baseline and 6 months; these mean grades were then used to calculate absolute change from baseline.|Baseline and 6 months|Right (OD) and left (OS) eyes|||scores on a scale|eyes|Standard Deviation|Mean
2632129|NCT01838655|Secondary|Absolute Change in Semi-quantitative Iris Pigmentation for Each Eye at 3 Months as Compared to Baseline|In Adobe Photoshop 7.0 the high resolution slit lamp image was divided into 4 quadrants with vertical and horizontal lines transecting the center of the iris. Using the elliptical marquee tool, a circle, approximately 0.25 times the diameter of the iris, was drawn in the center of each quadrant. Gaussian blur with radius of 50 was applied to the area enclosed in the 4 circles. With the dropper tool, the red pigment value corresponding to the degree of iris transillumination was sampled at the center of each circle. The 4 values were averaged to yield a composite transillumination score for each subject. Quantified values were then correlated to a scale score from 1 to 8 to generate an 8-point iris transillumination scale, with lower scores reflective of greater iris pigmentation (melanin content). The mean score across the 2 images for each participant's eye was calculated at baseline and 3 months; these mean grades were then used to calculate absolute change from baseline.|Baseline and 3 months|Right (OD) and left (OS) eyes|||scores on a scale|eyes|Standard Deviation|Mean
2632130|NCT01838655|Secondary|Absolute Mean Change in Iris Pigmentation on an 8-point Iris Transillumination Scale at 9 Months as Compared to Baseline. Participants Left and Right Eyes Will be Analyzed.|"High-resolution (2544x1696) digital images of the anterior segment of both eyes were captured prior to pupil dilation using diffuse illumination and iris transillumination. An independent reviewer selected two transillumination images from each eye of each participant for each visit according to preset quality criteria. Images were coded, randomized and presented to a panel of 18 graders on a SHARP 90 HD LED TV. After instruction and a practice dataset, graders scored each image using an 8-point scale. Graders could score images with a single decimal place if they felt an image fell in between two of the standards. The iris transillumination scale ranged from 0 to 8, with lower scores reflective of greater iris pigmentation (melanin content). The mean across all graders and the two images for each participant's eye at baseline and 9 months was calculated; these mean grades were then used to calculate absolute change from baseline at 9 months."|Baseline and 9 months|Right (OD) and left (OS) eyes|||scores on a scale|eyes|Standard Deviation|Mean
2632131|NCT01838655|Secondary|Absolute Mean Change in Iris Pigmentation on an 8-point Iris Transillumination Scale at 6 Months as Compared to Baseline. Participants Left and Right Eyes Will be Analyzed.|"High-resolution (2544x1696) digital images of the anterior segment of both eyes were captured prior to pupil dilation using diffuse illumination and iris transillumination. An independent reviewer selected two transillumination images from each eye of each participant for each visit according to preset quality criteria. Images were coded, randomized and presented to a panel of 18 graders on a SHARP 90 HD LED TV. After instruction and a practice dataset, graders scored each image using an 8-point scale. Graders could score images with a single decimal place if they felt an image fell in between two of the standards. The iris transillumination scale ranged from 0 to 8, with lower scores reflective of greater iris pigmentation (melanin content). The mean across all graders and the two images for each participant's eye at baseline and 6 months was calculated; these mean grades were then used to calculate absolute change from baseline at 6 months."|Baseline and 6 months|Right (OD) and left (OS) eyes|||scores on a scale|eyes|Standard Deviation|Mean
2632132|NCT01838655|Secondary|Absolute Mean Change in Iris Pigmentation on an 8-point Iris Transillumination Scale at 3 Months as Compared to Baseline. Participants Left and Right Eyes Will be Analyzed.|"High-resolution (2544x1696) digital images of the anterior segment of both eyes were captured prior to pupil dilation using diffuse illumination and iris transillumination. An independent reviewer selected two transillumination images from each eye of each participant for each visit according to preset quality criteria. Images were coded, randomized and presented to a panel of 18 graders on a SHARP 90 HD LED TV. After instruction and a practice dataset, graders scored each image using an 8-point scale. Graders could score images with a single decimal place if they felt an image fell in between two of the standards. The iris transillumination scale ranged from 0 to 8, with lower scores reflective of greater iris pigmentation (melanin content). The mean across all graders and the two images for each participant's eye at baseline and 3 months was calculated; these mean grades were then used to calculate absolute change from baseline at 3 months."|Baseline and 3 months|Right (OD) and left (OS) eyes|||scores on a scale|eyes|Standard Deviation|Mean
2632133|NCT01838655|Primary|Absolute Mean Change in Iris Pigmentation on an 8-point Iris Transillumination Scale at 12 Months as Compared to Baseline. Participants Left and Right Eyes Will be Analyzed.|"High-resolution (2544x1696) digital images of the anterior segment of both eyes were captured prior to pupil dilation using diffuse illumination and iris transillumination. An independent reviewer selected two transillumination images from each eye of each participant for each visit according to preset quality criteria. Images were coded, randomized and presented to a panel of 18 graders on a SHARP 90 HD LED TV. After instruction and a practice dataset, graders scored each image using an 8-point scale. Graders could score images with a single decimal place if they felt an image fell in between two of the standards. The iris transillumination scale ranged from 0 to 8, with lower scores reflective of greater iris pigmentation (melanin content). The mean across all graders and the two images for each participant's eye at baseline and 12 months was calculated; these mean grades were then used to calculate absolute change from baseline at 12 months."|Baseline and 12 months|Right (OD) and left (OS) eyes|||scores on a scale|eyes|Standard Deviation|Mean
2632134|NCT01838642|Secondary|Overall Survival|Overall survival is defined as the time between the first day of treatment to the day of disease progression.|up to 6 months|No participants were enrolled in the RET mutation negative group; study closed prematurely.|||months||Full Range|Mean
2632135|NCT01838642|Secondary|Changes in Serum Levels of MTC Tumor Markers Carcinoemybryonic Antigen (CEA) and Its Relation With Clinical Response|Responders are those subjects with a best biomarker response of complete response (CR) or partial response (PR) and who achieve a clinical response of CR or PR assessed by the following criteria. Biomarker: complete response (CR) is normalization (</= upper limit of normal (ULN)) of CTN (i.e., normal 0-2.5 mcg/L) following treatment, confirmed with a repeat CEA level at least 4 weeks apart. Partial response (PR) is a >/=50% decrease in the CEA level relative to baseline level, confirmed with a repeat CEA level at least 4 weeks apart. Clinical: complete response (CR) is an average of 0-2 formed stools per day for a period of at least 4 weeks. Partial response (PR) is a >50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks.|Baseline to 4 weeks|None of the participants achieved a clinical response and no data were collected for this assessment. No participants were enrolled in the RET mutation negative group; study closed prematurely.||||||
2632136|NCT01838642|Secondary|Objective Response to Ponatinib|Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (Whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Stable disease (SD) is neither shrinkage to qualify for PR nor sufficient increase to qualify for PD.|up to 4 cycles of treatment with ponatinib|One participant died on study during cycle 2. No participants were enrolled in the RET mutation negative group; study closed prematurely.|||participants|||Number
2632137|NCT01838642|Secondary|Changes in Serum Levels of MTC Tumor Markers Calcitonin (CTN) and Its Relation With Clinical Response|Responders are those subjects with a best biomarker response of complete response (CR) or partial response (PR) and who achieve a clinical response of CR or PR assessed by the following criteria. Biomarker: complete response (CR) is normalization (</= upper limit of normal (ULN)) of CTN (i.e., normal <10 pg/mL) following treatment, confirmed with a repeat CTN level at least 4 weeks apart. Partial response (PR) is a >/=50% decrease in the CTN level relative to baseline level, confirmed with a repeat CTN level at least 4 weeks apart. Clinical: complete response (CR) is an average of 0-2 formed stools per day for a period of at least 4 weeks. Partial response (PR) is a >50% decrease in the average stool frequency relative to baseline and a change in stool consistency from watery to loose (partially formed) for a period of at least 4 weeks.|Baseline to 4 weeks|None of the participants achieved a clinical response and no data were collected for this assessment. No participants were enrolled in the RET mutation negative group; study closed prematurely.||||||
2632138|NCT01838642|Secondary|Molecular Differences in Advanced Medullary Thyroid Cancer (MTC)|Compare the molecular profile of tumor deoxyribonucleic acid (DNA) prior to treatment with the molecular profile at the time of progression. Prior to the first dose of ponatinib and at time of progression, subjects were to undergo a biopsy of the primary tumor or any metastatic site for analysis of tumor DNA for rearranged during transfection (RET) or rat sarcoma (RAS) mutation. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% decrease in the sum of diameters of target lesions, taking as reference the smallest sum on study.|Prior to the first dose of ponatinib|Although molecular profiling was to be completed prior to first dose of ponatinib and at time of progression, samples were tested on arrival only as mutational status was an eligibility requirement. No participants were enrolled in the RET mutation negative group; study closed prematurely.|||participants|||Number
2632139|NCT01838642|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|17 months and 19 days|No participants were enrolled in the RET mutation negative group; study closed prematurely.|||participants|||Number
2632140|NCT01838642|Secondary|Progression Free Survival|Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.|2-4 months|No participants were enrolled in the RET mutation negative group; study closed prematurely.|||months||Full Range|Mean
2632141|NCT01838642|Primary|Overall Response Rate.|Defined as the percentage of participants with a best response (complete response (CR) + partial response (PR)) recorded from the start of the treatment until disease progression/recurrence assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (Whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.|2-4 months|No participants were enrolled in the RET mutation negative group; study closed prematurely.|||percentage of participants|||Number
2632142|NCT01838616|Secondary|Composite Event Based Comparison of Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids|"In this outcome measure the early gastrointestinal-related treatment emergent events (TEAEs) were evaluated. As the trial population was opioid-naïve this was considered of interest.~The composition score of reported events of Mild, moderate to severe nausea and/or Mild, moderate to severe vomiting and/or Mild, moderate to severe constipation was evaluated."|Baseline (Randomization Visit); End of Week 3 (End of Titration Period)|Safety Set (SAF).|||number of events|||Number
2632143|NCT01838616|Secondary|Comparison of the Number of Participants Affected by Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids|"In this outcome measure the number of participants affected by early gastrointestinal-related treatment emergent adverse events (TEAEs). As the trial population was opioid-naïve this was considered of interest.~The composition score from participant who reported:~Mild, moderate to severe nausea and/or Mild, moderate to severe vomiting and/or Mild, moderate to severe constipation was evaluated."|Baseline (Randomization Visit) to End of Titration Period (End of Week 3)|Safety Set (SAF).|||participants|||Number
2632341|NCT01836029|Secondary|Comparison of the Objective Response Rate Between the Two Treatment Groups p|Objective response rate is defined as the percentage of subjects who achieve best overall response of irCR or irPR pr irRECIST and evaluated by independent radiology..|From the time of randomization until the best response on treatment is documented.|ITT population|||percentage of participants|||Number
2632145|NCT01838616|Secondary|Sleep Evaluation: Latency (Time Taken to Fall Asleep)|The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the Randomization Visit (Baseline) and for the night prior to the Final Evaluation Visit (12 weeks after randomization). The higher the value the longer it took to fall asleep.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS).|||hours||Standard Deviation|Mean
2632146|NCT01838616|Secondary|Sleep Evaluation at the End of Treatment: Change in the Number of Hours Slept|The sleep evaluation questionnaire was completed by the participant. The answer was in response to the question: Sleep evaluation: How long did you sleep last night [hours]? The value reported is the change in the number of hours of sleep from baseline. The positive value indicates that there was an increase in the number of hours of sleep in a treatment group.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).|||hours||Standard Error|Least Squares Mean
2632147|NCT01838616|Secondary|Sleep Evaluation: Number of Hours Slept|"The participants were requested to answer the following question:~How long did you sleep last night [hours]? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline) and for the night prior to the End of the Continuation Visit (12 weeks after randomization)."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).|||hours||Standard Deviation|Mean
2632148|NCT01838616|Secondary|Sleep Evaluation at the End of Treatment: Change in the Number of Awakenings|The participants were requested to answer the question: How many times did you wake up during the night? The values were calculated from the data that participants self-reported. The change from baseline in the number of times of waking up during the night in a treatment group is reported. A negative symbol indicates that there was a reduction in the number of awakenings.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||number of awakenings||Standard Error|Least Squares Mean
2632149|NCT01838616|Secondary|Sleep Evaluation: Number of Awakenings|"The participants were requested to answer the following question:~How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline) and for the night prior to the End of the Continuation Visit (12 weeks after randomization)."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||number of awakenings||Standard Deviation|Mean
2632150|NCT01838616|Secondary|Sleep Evaluation at the End of Treatment: Change in the Overall Quality of Sleep|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor.~The improvement, no change or worsening is reported based on the replies scored by the participants given at their End of Continuation Visit."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).|||participants|||Number
2632151|NCT01838616|Secondary|Clinician Global Impression of Change at the End of Treatment|"In the Clinician Global Impression of Change (CGIC) the clinician indicated the perceived change over the treatment period. The clinician was requested to choose one of seven categories for each participant. The Clinician rated the participants change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).|||participants|||Number
2632152|NCT01838616|Secondary|Patient Global Impression of Change at the End of Treatment|"In the Patient Global Impression of Change (PGIC) the participant indicated the perceived change over the treatment period. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||participants|||Number
2632153|NCT01838616|Secondary|Change in Hospital Anxiety and Depression Scale at the End of Treatment: Depression|The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement. A negative change value indicates a decrease in the depression score since the start of treatment.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last observation carried forward (LOCF). Number of participants with data available.|||units on a scale||Standard Error|Least Squares Mean
2632154|NCT01838616|Secondary|Hospital Anxiety and Depression Scale: Depression|The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last observation carried forward (LOCF). Number of participants with data available.|||units on a scale||Standard Deviation|Mean
2632170|NCT01838616|Secondary|Recalled Average Pain Intensity|"The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS), on this scale 0 indicates no pain and 10 indicates pain as bad as you can imagine. This scale recalls the average pain intensity during the last 3 days. The participant was asked: Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
2632155|NCT01838616|Secondary|Change in Hospital Anxiety and Depression Scale at the End of Treatment: Anxiety|"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.~A negative sign indicates that there has been a decrease in anxiety since the start of treatment."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Error|Least Squares Mean
2632156|NCT01838616|Secondary|Hospital Anxiety and Depression Scale: Anxiety|"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.~A decrease in values over the trial period indicate that there has been an improvement."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Deviation|Mean
2632157|NCT01838616|Secondary|Change in EuroQol-5 (EQ-5D) Health Status Index Outcome at the End of Treatment|"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Error|Least Squares Mean
2632158|NCT01838616|Secondary|EuroQol-5 (EQ-5D) Health Status Index Outcome|"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Deviation|Mean
2632159|NCT01838616|Secondary|Changes in the Short Form Health Survey (SF-12) at the End of Treatment|"The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical and mental summary scores were calculated from the individual responses. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.~The change in the SF-12 score shows an improvement in health from baseline if the values are positive. The higher the value the greater the improvement since starting the trial."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS), Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Error|Least Squares Mean
2632160|NCT01838616|Secondary|Short Form Health Survey (SF-12)|The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical and mental summary scores were calculated from the individual responses. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Deviation|Mean
2632161|NCT01838616|Secondary|Change in Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment at the End of Treatment|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale, from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 1. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 1. A negative change indicates that the intensity of the symptom has decreased since the start of treatment.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2632185|NCT01838447|Secondary|Number of Participants With Hypercalciuria|Hypercalciuria will be identified using calcium:creatinine ratios defined using age-specific norms and thresholds.|Immediately before surgery, on admission to the PICU following CHD surgery, and on the first post-operative day||||Participants|||Count of Participants
2632186|NCT01838447|Secondary|Number of Participants With Hypercalcemia as a Vitamin D Related Adverse Event|Hypercalcemia will be defined as an ionized calcium level above 1.40 mmol/L; or above 1.45 mmol/L for children under 8 weeks. Hypercalcemia will be evaluated in blood collected immediately before CHD surgery and throughout the post-operative course (measurements are standard of care).|Immediately before surgery, on admission to the PICU following CHD surgery, and on post-operative days 1,3,5 & 10||||No. participants with hypercalcemia|||Number
2632162|NCT01838616|Secondary|Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 1. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 1.|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Deviation|Mean
2632163|NCT01838616|Secondary|Change in painDETECT Final Assessment at the End of Treatment|"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear. The theoretical range of change in this trial ranged from -38 to 15. A negative change indicated a decrease in their neuropathic component of pain."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Error|Least Squares Mean
2632164|NCT01838616|Secondary|painDETECT Final Assessment|"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear. The theoretical range of change in this trial ranged from -38 to 15. A negative change indicated a decrease in their neuropathic component of pain."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Deviation|Mean
2632165|NCT01838616|Secondary|Change in Worst Pain Intensity Over the Past 24 Hours at the End of Treatment|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked: Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit.~A negative change indicates that the pain intensity decreased from the start of the trial."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Error|Least Squares Mean
2632166|NCT01838616|Secondary|Worst Pain Intensity Over the Past 24 Hours|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked: Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit"|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Deviation|Mean
2632167|NCT01838616|Secondary|Change of Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg at the End of Treatment|"Typical dermatomal pain was defined as being pain that radiates beyond the knee towards the foot (sciatica) or pain evoked by stretching of the sciatic nerve.~Therefore, the participant was asked to rate their pain intensity over the past 3 days with regards to this particular pain characteristic.~The recalled average pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~A negative sign indicates that there was a decrease in the average pain radiating towards or into the leg."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Error|Least Squares Mean
2632168|NCT01838616|Secondary|Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg|"Typical dermatomal pain was defined as being pain that radiates beyond the knee towards the foot (sciatica) or pain evoked by stretching of the sciatic nerve.~The participant was asked to rate their pain intensity over the past 3 days with regards to this particular pain characteristic.~The recalled average pain intensity over the past 3 days for the pain radiating towards or into the leg was assessed by the participant using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.|||units on a scale||Standard Deviation|Mean
2632169|NCT01838616|Secondary|Change in Recalled Average Pain Intensity at the End of Treatment|"The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS), on this scale 0 indicates no pain and 10 indicates pain as bad as you can imagine. This scale recorded the average pain intensity recalled by the participant during the previous 3 days. The participant was asked: Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit). A negative sign indicates a decrease in pain from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (baseline visit)."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2632187|NCT01838447|Primary|Blood 25 Hydroxyvitamin D (25OHD) Concentrations|Blood 25OHD will be measured to determine vitamin D deficiency, with a concentration below 50 nmol/L used to define deficiency. A PICU admission blood sample could not be obtained for one patient in the Usual Care Group and one patient in the High Dose Group, thus the total number analyzed differs from the full sample size.|1 day (On admission to the pediatric intensive care unit (PICU) following CHD surgery)||||nmol/L||Standard Deviation|Mean
2632171|NCT01838616|Primary|Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) Total Score|"The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assessed the severity of symptoms of constipation. Participants were asked How severe have each of these symptoms been in the last two weeks? e.g. Pain in your stomach. There are 3 subscales: 4 questions on abdominal symptoms, 3 on rectal symptoms and 5 on stool symptoms. Responses were rated on a 5-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). If the changes in the overall or subscale scores are positive then there is a worsening in symptoms associated with constipation. The change in the assessment of constipation symptoms (PAC-SYM) total score from the Randomization Visit to the Final Evaluation Visit. The PAC-SYM overall score is the sum of scores of all non-missing items divided by the number of non-missing items (if at least 6 items were non-missing)."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|The primary analysis was performed for the Per Protocol Set (PPS).|||units on a scale||Standard Error|Least Squares Mean
2632172|NCT01838616|Primary|Change in the Average Pain Intensity Score on an 11-point Numeric Rating Scale (NRS-3)|"For this pain assessment, the participant indicated the level of average pain experienced over the previous 3 days on an 11-point Numeric Rating Scale (NRS-3) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value reported represents the change from the randomization visit (i.e., the last 3 days in the washout period prior to Investigational Medicinal Product initiation and titration) to the end of the continuation period (i.e., up to 9 weeks on the stable dose). The theoretical values range from -10 to 10. A negative sign indicates a decrease in pain from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (Baseline Visit)."|Baseline (Randomization Visit); End of Continuation Period (Week 12)|The primary analysis was performed for the Per Protocol Set (PPS). Last Observation Carried Forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2632173|NCT01838590|Secondary|Percentage of Participants Experiencing Virologic Relapse|Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2632174|NCT01838590|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
2632175|NCT01838590|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
2632176|NCT01838590|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug|||percentage of participants|||Number
2632177|NCT01838590|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 4 HCV infection who were randomized and received at least one dose of study drug|||percentage of participants|||Number
2632178|NCT01838499|Secondary|Change From Baseline to 12 Weeks in Numerical Assessment Scale Numerical Rating Scale for Pain|"Assessment of change in pain via Numerical Rating Scale. Daily pain is reported by the subject using an 11-point 0 (no pain) to 10 (worst pain imaginable) numeric rating scale.~Baseline score is the average of the values collected in the 7 days prior to first dose of study drug. Each Visit score is the average of the values collected in the 7 days prior to that visit."|12 weeks|FAS (LOCF)|||changes in scores on a scale||Standard Error|Least Squares Mean
2632179|NCT01838499|Secondary|"2) Subject's Global Impression of Change Reported on PGIC Scale (1-7 Point Scale Ranging From 1 Very Much Improved to 7 Very Much Worse)"|"Percentage of subjects achieving a clinically significant response measured by the proportion of subjects who are minimally improved, much improved or very much improved on the Patient's Global Impression of Change (PGIC)"|12 weeks||||% of patients|||Number
2632180|NCT01838499|Primary|1) Percentage of Subjects Achieving a Clinically Relevant Response in Physician Global Assessment (PGA), With Score 0,1 or 2 From Baseline to 12 Weeks|Percentage of subjects achieving a clinically significant response measured by the proportion of subjects who achieve 0, 1, or 2 PGA by the end of week 12|12 weeks|FAS|||% of patients|||Number
2632181|NCT01838447|Secondary|Cardiovascular Function Through an Echocardiogram|The post-operative day 1 echocardiogram will be used to evaluate for differences in cardiovascular function between study arms.|Post-operative day 1|This data cannot be reported. Data was not collected.||||||
2632182|NCT01838447|Secondary|Post-operative PICU Catecholamine Requirements|Primarily, post-operative catecholamine requirements during the PICU admission will be evaluated as a dichotomous variable (yes/no). If a difference is noted in the primary analysis, inotrope requirements will be determined using the inotrope score, evaluated as the maximum score and in a time to event approach (off all inotropes, score of zero)|At any point between PICU admission and discharge, an average length of 5-7 days and not longer than 60 days|Only the primary analysis (post-operative catecholamine requirements during the PICU admission will be evaluated as a dichotomous variable (yes/no)) was completed. Since there was not a significant difference between groups for this variable, we did not perform the secondary analysis (inotrope score).|||Participants|||Count of Participants
2632183|NCT01838447|Secondary|Changes in Cathelicidin as Measure of Innate Immune Function||Immediately before surgery, on admission to the PICU following CHD surgery, and on post-operative days 1,3,5 & 10|This data cannot be reported. Data was not collected.||||||
2632184|NCT01838447|Secondary|Vitamin D Parathyroid Renal Axis Function Through Changes in Blood 1,25-dihydroxycholecalciferol|Impaired vitamin D axis function will be defined as an inability to restore and maintain active hormone levels in the normal range following surgery after the first post-operative day|Immediately before surgery, on admission to the PICU following CHD surgery, and on post-operative days 1,3,5 & 10|Data cannot be reported. Data was not collected.||||||
2632191|NCT01838304|Primary|Number of Participants Requiring Adjustment in Propofol Dosing|Following initial sedation, an infusion rate for propofol is determined by the CRNA (control) or software (experimental). If this rate is appropriate for the duration of the brief procedure, no adjustment to the rate will be required. A greater requirement for rate changes suggests that the anesthesia provider needs to be immediately available to perform these adjustments.|Intraprocedure (average of 9 minutes)||||Participants|||Count of Participants
2632192|NCT01838213|Other Pre-specified|Carriage of ESBL Producing Bacteria|Culture results from patient fecal samples will be collected up to 3 years after urinary tract infection and carriage of ESBL producing bacteria will be examined.|up to 3 years|||||||
2632193|NCT01838213|Secondary|Subjective Outcome|A patient form will be filled in. Data about cessation of symptoms of urinary tract infection will be recorded.|14 days|||||||
2632194|NCT01838213|Primary|Treatment Failure|"Patients included in the study with urinary tract infection (UTI) and treated as part of normal routine were followed for 14 days and further prescriptions of antimicrobials normally used for treatment of UTI will be considered treatment failures. Only participants that received pivmecillinam are reported here. In the paper published in PlosOne High Rate of Per Oral Mecillinam Treatment Failure in Community-Acquired Urinary Tract Infections Caused by ESBL-Producing Escherichia coli the mecillinam treatment group were compared with the group that did not receive mecillinam."|14 days after initiation of treatment|Patients that did receice pivmecillinam.|||Treatment success|||Number
2632195|NCT01838200|Secondary|Number of Patients With Best Overall Immune-related Tumor Response|Immune-related tumor responses were evaluated using computed tomography and clinical photography at Baseline, Weeks 6, 17, 21, and 30 (± 3-day window for each assessment), and at the end of the study. Tumor response was designated according to the immune-related Response Criteria (irRC) (Wolchok et al. Clin Cancer Res 2009;15:7412-20) into the following categories: immune-related complete response (irCR) requires disappearance of all lesions in two consecutive observations not less than 4 weeks apart; immune-related partial response (irPR) requires ≥ 50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart; immune-related stable disease (irSD) is assigned when neither a 50% decrease from baseline tumor burden nor a 25% increase in tumor burden from nadir can be established; immune-related progressive disease (irPD) requires a ≥ 25% increase from nadir in tumor burden at any single time point in two consecutive observations at least 4 weeks apart.|Up to 5 months|The Efficacy Analysis Set includes all patients who received at least 1 dose of study treatment and had response evaluated through Week 17.|||Participants|||Count of Participants
2632196|NCT01838200|Secondary|Number of Patients With Best Overall Clinical Tumor Response|Tumor responses were evaluated using computed tomography and clinical photography at Baseline, Weeks 6, 17, 21, and 30 (± 3-day window for each assessment), and at the end of the study. Tumor response was designated according to the Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1). Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions (no evaluable disease); Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.|Up to 5 months|The Efficacy Analysis Set includes all patients who received at least 1 dose of study treatment and had response evaluated through Week 17.|||Participants|||Count of Participants
2632197|NCT01838200|Primary|Number of Patients With Treatment-emergent Adverse Events|Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Dose-limiting toxicity (DLT) for BCG was defined as any ≥ Grade 3 local injection site reaction (ulceration or necrosis requiring operative intervention), and DLT for ipilimumab was defined as any toxicity that required dosing modifications in accordance with the recommendations in the local product labelling, or any ≥ Grade 3 hematologic or nonhematologic toxicity that was definitely, probably, or possibly related to the administration of ipilimumab.|Continuously for up to 5 months|The Safety Analysis Set includes all patients who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2632198|NCT01838044|Secondary|Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10|"The Daily Pain diary consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain."|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Percentage of participants|||Number
2632199|NCT01838044|Secondary|Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10|"The Daily Pain diary consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain."|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Percentage of participants|||Number
2632200|NCT01838044|Secondary|Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance Subscale at Week 5 and Week 10|The MOS-Sleep Scale is a self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflect greater impairment in the MOS-Sleep subscales. Sleep Disturbance: Range=0 to 100; higher scores indicate greater sleep disturbance. Negative changes indicate improvement.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Units on a scale||Standard Deviation|Mean
2632406|NCT01835158|Primary|Overall Survival (OS)|The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on OS. The Kaplan-Meier product-limit estimator will be used to estimate OS distributions.|Up to 5 years|All enrolled patients|||Months||95% Confidence Interval|Median
2632201|NCT01838044|Secondary|Change From Baseline in Brief Pain Inventory Short Form (BPI sf) - Pain Severity Index Score at Week 5 and Week 10|BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the past 24 hours. The Pain severity domain: The BPI severity domain includes pain at its 'worst,' 'least,' 'average,' and 'now' (current pain) on 0-10 NRS scales and takes the mean of these 4 items. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine), therefore higher scores indicate greater pain severity.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Units on a scale||Standard Deviation|Mean
2632202|NCT01838044|Secondary|Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2|Period 1 indicates from Visit 2 (baseline) to Visit 4 (Week 5). Period 2 indicates from Visit 4 (Week 5) to Visit 6 (Week 10). A rating of 0 is considered no pain; 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.|Period 1 and Period 2|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||% of days||Standard Deviation|Mean
2632203|NCT01838044|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS-D) Depression Scores at Week 5 (Visit 4) and Week 10 (Visit 6)|The HADS is a self-administered questionnaire measuring depression. Each subscale consists of 7 statements and the participants respond as to how each item applies to them on a scale of 0 to 3 (0 = No depression, to 3 = Severe feelings of depression). Separate scores are calculated for each subscale and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score the more severe the depression.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Units on a scale||Standard Deviation|Mean
2632204|NCT01838044|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS-A) Anxiety Scores at Week 5 (Visit 4) and Week 10 (Visit 6)|The HADS is a self-administered questionnaire measuring anxiety. Each subscale consists of 7 statements and the participants respond as to how each item applies to them on a scale of 0 to 3 (0 = No anxiety, to 3 = Severe feelings of anxiety). Separate scores are calculated for each subscale and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score the more severe the anxiety.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Units on a scale||Standard Deviation|Mean
2632205|NCT01838044|Secondary|Change From Baseline in Weekly Mean of Daily Sleep Interference Rating Scale (SIRS) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)|"The Daily Sleep Interference Rating Scale (SIRS) consists of an 11-point NRS ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep [unable to sleep due to pain]). Participants described how pain had interfered with their sleep during the past 24 hours: Select the number that best describes how your pain has interfered with your sleep during the past 24 hours on a scale from 0 to 10 where 0 represents 'does not interfere with sleep' and 10 represents 'completely interferes' which means you are unable to sleep due to pain."|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Units on a scale||Standard Error|Least Squares Mean
2632206|NCT01838044|Secondary|Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6)|The PGIC is a single-item, self-rated instrument that measures change in the patient's overall status since starting study medication on a scale from 1 (very much improved) to 7 (very much worse), where lower scores indicate greater improvement. This scale was administered at Visit 4 and Visit 6.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||percentage of participants|||Number
2632207|NCT01838044|Secondary|Patient Global Impression of Change (PGIC) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)|The PGIC is a single-item, self-rated instrument that measures change in the patient's overall status since starting study medication on a scale from 1 (very much improved) to 7 (very much worse), where lower scores indicate greater improvement. This scale was administered at Visit 4 and Visit 6.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Units on a scale||Standard Deviation|Mean
2632208|NCT01838044|Secondary|Change From Baseline in Benefit, Satisfaction, and Willingness to Continue Measure Scores Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)|The BSW consists of 3, single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was administered by the investigator or designated site personnel in the local language as a standardized interview during the follow-up visits. The BSW can potentially be self-administered; however, this method of administration has not been tested. Participants completed this questionnaire at Visit 4 and Visit 6.|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Percentage of participants|||Number
2632209|NCT01838044|Secondary|Change From Baseline in the Weekly Mean Pain NRS Score at Week 10 (Visit 6) Compared Between the Two Study Arms|"The Daily Pain diary consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain."|Baseline and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Units on a scale||Standard Error|Least Squares Mean
2632210|NCT01838044|Secondary|Change in the Weekly Mean Pain NRS Score in Arm B, Compared Between Week 5 (Visit 4) and Week 10 (Visit 6).|"The Daily Pain diary consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain."|Week 5 and Week 10|The FAS that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Units on a scale||Standard Error|Least Squares Mean
2633072|NCT01829503|Secondary|Numbers of Patients (Out of 44) Experiencing Adverse Events With CTCAE Grade ≥ 3 or Adverse Events Grade ≥ 4|The number of participants (out of 44) experiencing adverse events, with CTCAE Grade ≥ 3 or Adverse Events Grade ≥ 4|Up to 38 months|All study participants.|||Participants|||Number
2632211|NCT01838044|Primary|Change From Baseline in the Weekly Mean Pain Numeric Rating Scale (NRS) Score at Week 5 (ie, Visit 4) Compared Between the Two Study Arms|"The Daily Pain diary consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain."|Baseline and Week 5|The Full Analysis Set (FAS) that comprised all participants who took at least one dose of study medication (either pregabalin or celecoxib).|||Units on a scale||Standard Error|Mean
2632212|NCT01837966|Primary|Anxiety Reduction|We hoped to show that lavender aroma therapy reduces preoperative anxiety in patients undergoing breast. The Trait subscale (STAI-TRAID) of the Spielberger State-Trait Anxiety Inventory was administered before and after 10 minutes of aromatherapy treatment pre-surgery. The TRAIT subscale contains 20 questions scored on a Likert scale from 1-4; item scores are summed for a total score ranging from 20 to 80, with higher scores indicating higher anxiety. Change in anxiety was calculated as the score pre-aromatherapy minus the score post-aromatherapy. Higher positive change scores indicate greater reductions in anxiety.|20 minutes before surgery (pre aromatherapy) and 10 minutes before surgery (post aromatherapy)|Analysis of STAI-TRAIT questions|||units on a scale||Standard Deviation|Mean
2632213|NCT01837823|Secondary|MACE|Major Adverse Cardiac Events (MACE) defined as a combined clinical endpoint of death, MI (Q wave or non Q-wave with CK-MB >3 times above the upper normal limit (48 U/L), urgent revascularization or stroke at 1 year.|at 1 year||||Participants|||Count of Participants
2632214|NCT01837823|Secondary|MACE|Major Adverse Cardiac Events (MACE) defined as a combined clinical endpoint of death, MI (Q wave or non Q-wave with CK-MB >3 times above the upper normal limit (48 U/L), urgent revascularization or stroke at 30 days.|at 30 days||||Participants|||Count of Participants
2632215|NCT01837823|Secondary|Correlation of Changes in Plaque Morphology|"Correlation of changes in plaque morphology by OCT, IVUS and NIRS with the perturbations in peripheral blood mononuclear cell transcriptome using microarray analysis.~data not collected for this measure."|baseline and at 8-12 weeks|||||||
2632216|NCT01837823|Secondary|Mechanism of Reverse Cholesterol Transport|To assess the mechanism of reverse cholesterol transport that arises with high-dose statin therapy, as related to changes in plaque lipid content and morphology, and systemic vascular inflammation. Reverse cholesterol transport (RCT) is a pathway by which accumulated cholesterol is transported from the vessel wall to the liver for excretion, thus preventing atherosclerosis.|baseline and at 8-12 weeks||||percentage of cholesterol||Standard Deviation|Mean
2632217|NCT01837823|Secondary|Plaque Morphology as Related to Haptoglobin|To relate changes in plaque lipid content and morphology to the patient haptoglobin genotype.|baseline and at 8-12 weeks|Only those participants with these genotypes were analyzed|||LCBI4mm max||Standard Deviation|Mean
2632218|NCT01837823|Secondary|Correlation of Baseline Lipid Parameters With Baseline LCBI4mm Max|Correlation of baseline lipid parameters with baseline LCBI4mm max|baseline||||Beta coefficient||95% Confidence Interval|Number
2632219|NCT01837823|Secondary|Biomarker Release|Post procedure CK-MB, Troponin-I release at final YELLOW lesion PCI.|within 24 hrs of PCI||||ng/ml||Standard Deviation|Mean
2632220|NCT01837823|Secondary|Change in Atheroma Volume|Change in total atheroma volume (TAV) and lumen cross sectional area on OCT.|baseline and at 8-12 weeks||||mm^3||Standard Deviation|Mean
2632221|NCT01837823|Secondary|LCBI 4mm at Same Anatomical Site|"As related to other outcomes, change in LCBI 4mm measured at the identical anatomical site at both time points, as defined by the LCBI4mm max site at baseline (rather than ΔLCBI4mm max).~LCBI4mm: 4-mm long segment with maximum lipid core burden index (LCBI), where the LCBI is calculated as the fraction of yellow pixels on a chemogram x 1000. Each pixel on the chemogram represents a probability of lipid presence in the given region; pixels are color-coded on a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow."|at baseline and at 8-12 weeks||||LCBI4mm max||Standard Deviation|Mean
2632222|NCT01837823|Secondary|Lesion LCBI|As related to other outcomes, change in LCBI measured across the entire lesion (rather than ΔLCBI4mm max). The LCBI Score, computed as the fraction of valid pixels within the scanned region that exceeded a LCP probability of 0.6 multiplied by 1000, summarized the amount of LCP in the entire scanned region of the coronary vessel on a 0-to-1000 scale .|at baseline and at 8-12 weeks||||LCBI4mm max||Inter-Quartile Range|Median
2632223|NCT01837823|Secondary|Inflammatory and Lipid Parameters|ΔLCBI4mm max will be related to Δ values from baseline to 8-12 weeks thereafter in inflammatory and lipid parameters responses to patient-derived samples.|baseline and at 8-12 weeks||||mg/dl||Standard Deviation|Mean
2632224|NCT01837823|Secondary|IVUS Imaging Measures|Correlation between ΔLCBI4mm max will be related to Δ values from baseline to 8-12 weeks thereafter in specific IVUS (ΔPlaque burden) imaging measures. Plaque burden is Plaque + Media divided by Total Plaque Area in %.|Baseline and 8 weeks||||percent of plaque burden||Standard Deviation|Mean
2632225|NCT01837823|Secondary|Fibrous Cap Thickness (FCT) by OCT|ΔFibrous Cap Thickness measured by OCT at baseline and at 8-12 weeks|baseline and at 8-12 weeks||||μm||Standard Deviation|Mean
2632226|NCT01837823|Secondary|Maximal 4mm Lipid Core Burden Index (LCBI 4mm Max)|"Maximum LCBI 4mm (ΔLCBI4mm max) of the non-culprit YELLOW lesion at baseline and 8-12 weeks thereafter.~LCBI4mm max : 4-mm long segment with maximum lipid core burden index (LCBI), where the LCBI is calculated as the fraction of yellow pixels on a chemogram x 1000. Each pixel on the chemogram represents a probability of lipid presence in the given region; pixels are color-coded on a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow."|baseline and at 8-12 weeks||||LCBI4mm max||Standard Deviation|Mean
2632227|NCT01837823|Primary|Correlation Between the Change in Fibrous Cap Thickness and Hs-CRP|Correlation between the change in plaque morphology composition by intravascular imaging with inflammatory cell activity.|baseline and 8-12 weeks||||beta coefficient||95% Confidence Interval|Number
2632228|NCT01837823|Primary|Correlation Between Plaque Morphology and HDL Functionality|Correlation between the changes in plaque morphology composition by intravascular imaging with changes in HDL functionality. HDL functionality is measured by the Cholesterol Efflux Capacity (CEC). Plaque morphology is represented by the Fibrous Cap Thickness.|baseline and 8-12 weeks||||beta coefficient||95% Confidence Interval|Number
2632229|NCT01837797|Secondary|Number of Patients With Risk of Suicidality Assessed Using the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS)|The Columbia Suicide Severity Rating Scale (eC-SSRS) is a semi-structured interview developed to systematically assess suicidal ideation and behaviour of patients participating in a clinical study. The C-SSRS has 5 questions addressing suicidal ideation, 5 sub-questions assessing the intensity of ideation, and 4 questions addressing suicidal behaviour.|From randomisation to end of treatment (week 20)|15 patients were enrolled to Period 2, only 3 patients completed due to study termination|||participants|||Number
2632230|NCT01837797|Secondary|Sustained Remission During the Randomised Treatment|Based on a pre-specified MADRS total score|From randomisation to end of treatment (week 20)|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected||||||
2632231|NCT01837797|Secondary|Remission During the Randomised Treatment|Based on a pre-specified MADRS total score|From randomisation to end of treatment (week 20)|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected||||||
2632232|NCT01837797|Secondary|Sustained Response During the Randomised Treatment|Based on a pre-specified decrease in MADRS total score|From randomisation to end of treatment (week 20)|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected||||||
2632233|NCT01837797|Secondary|Response During the Randomised Treatment|Based on a pre-specified decrease in MADRS total score|From randomisation to end of treatment (week 20)|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected||||||
2632234|NCT01837797|Secondary|Change From Randomisation in Social Adaptation During the Randomised Treatment|Social Adaptation Self-evaluation Scale (SASS) total score|From randomisation to end of treatment (week 20)|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected||||||
2632235|NCT01837797|Secondary|Change From Randomisation in Functionality Assessed by SDS During the Randomised Treatment|Sheehan Disability Scale (SDS) total score|From randomisation to end of treatment (week 20)|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected||||||
2632236|NCT01837797|Secondary|Change From Randomisation in Clinical Global Impression During the Randomised Treatment|Clinical Global Impression - Severity of illness (CGI-S) score|From randomisation to end of treatment (week 20)|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected||||||
2632237|NCT01837797|Primary|Change From Randomisation in Depressive Symptoms During the Randomised Treatment|Montgomery and Aasberg Depression Rating Scale (MADRS) total score|From randomisation to end of treatment (week 20)|Only 3 patients completed study Period 2. A total of 129 patients were enrolled when the study was terminated (Planned: 1334 patients). The limited number of enrolled patients would result in insufficient data for analyses, therefore, no data were collected||||||
2632238|NCT01837797|Secondary|Number of Adverse Events|15 patients were enrolled to Period 2; only 3 patients completed due to study termination|From randomisation to follow-up (week 24)||||Adverse events|||Number
2632239|NCT01837719|Secondary|T-HALF of Cobicistat|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. T-HALF was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.|||Hours||Standard Deviation|Mean
2632240|NCT01837719|Secondary|Area Under the Concentration Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-T]) and Area Under the Concentration Curve From Time 0 to Infinity (AUC[INF]) of Cobicistat|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. AUC(0-T) and AUC(INF) were derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis. n=evaluable participants|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2632241|NCT01837719|Secondary|Time of Maximum Observed Concentration (Tmax) of Cobicistat|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Tmax was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.|||Hours||Full Range|Median
2632342|NCT01836029|Secondary|Comparison of Overall Survival (OS) Between the 2 Treatment Groups.|Estimated using Kaplan-Meier product limit estimates, 1-sided stratified log-rank test, and Cox proportional hazard model; all with 90% 1-sided confidence intervals.|OS is the time from randomization until death due to any cause or the date last confirmed to be alive.|ITT population|||days||90% Confidence Interval|Median
2632242|NCT01837719|Secondary|Maximum Observed Plasma Concentration (Cmax) of Cobicistat|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Cmax was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (1,2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2632243|NCT01837719|Secondary|Apparent Terminal Half-life (T-HALF) of Atazanavir|Blood samples for testing plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. T-HALF was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.|||Hours||Standard Deviation|Mean
2632244|NCT01837719|Secondary|Observed Concentration at 24 Hours (C24) of Atazanavir|Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. C24 was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2632245|NCT01837719|Secondary|Time of Maximum Observed Concentration (Tmax) of Atazanavir|Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Tmax was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.|||Hours||Full Range|Median
2632246|NCT01837719|Secondary|Number of Participants With Out-of-range Intervals on Electrocardiogram (ECG) Findings|A 12-lead ECG was recorded at predose and 4 hours post dose at screening, Days -1, 1, 8 15, 22, 29 and study discharge. ECGs were recorded after the patient had been supine for at least 5 minutes. All ECG readings post dosing (including unscheduled) were included.|At screening; on Day -1; predose and 4 hours postdose on Days 1, 18, 15, 22, and 29; and at study discharge (Day 31)|All participants who received at least 1 dose of study medication and were evaluable.|||Participants|||Number
2632247|NCT01837719|Secondary|Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests|LLN=lower limit of normal; ULN=upper limit of normal; preRx=pretreatment; h=high; hpf=high power field. Abnormal criteria: Leukocytes, low (*10^3 c/uL): <0.85*preRx if preRx<LLN; <0.9*LLN if LLN≤preRx≤ULN;< 0.9*LLN if preRx=missing;<LLN if preRX>ULN. Neutrophils, low (*10^3 c/uL): <0.85*preRx if preRx<1.5; <1.5 if preRx=missing; <1.5 if preRx ≥1.5. Bilirubin, h (mg/dL): >1.1* ULN if preRx≤ULN; >1.1*ULN if preRx=missing; >1.25*preRx if preRx>ULN. Bilirubin, h (mg/dL): >1.1* ULN if preRx≤ULN; >1.1*ULN if preRx=missing; >1.25*preRx if preRx>ULN. Blood, urine, h: ≥2*preRx if preRx≥1; ≥2 if preRx <1; ≥2 if preRx=missing. RBCs/WBCs, h (hpf): ≥2 if preRx=missing ≥2 if preRx<2 ≥4 if preRx ≥2. Creatine kinase, h (U/L): >1.5*preRx if preRx>ULN; >1.5*ULN if preRx≤ULN; >1.5*ULN if preRx=missing; AST, h (U/L): >1.25* preRx if preRx>ULN; >1.25*ULN if preRx≤ULN; >1.25*ULN if preRx=missing. Lactate dehydrogenase, h (U/L): >1.25*ULN if preRx≤ULN; >1.25*ULN if preRx=missing; >1.5*preRx if preRx>ULN.|At Screening and on Days -1,4, 11, 18, and 31 (study discharge)|All participants who received at least 1 dose of study drug and had laboratory test results available.|||Participants|||Number
2632248|NCT01837719|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs)|An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant who receives an investigational product and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE is any untoward medical occurrence that at any dose results in death; is life-threatening; or requires or prolongs inpatient hospitalization.|On Day 24 or 31|All participants who received at least 1 dose of any study drug.|||Participants|||Number
2632249|NCT01837719|Primary|Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of Last Quantifiable Concentration (AUC[0-T]) and From Time 0 to Infinity (AUC[INF]) for Atazanavir|Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. AUC(0-T) and AUC(INF) were derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2632311|NCT01836445|Other Pre-specified|Participant Rating of Intervention Acceptability and Tolerability|Participant rating of how much they enjoyed the intervention and participant feedback and suggestions for improvement. Range 1-4; higher scores indicate greater acceptability.|Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)|Enrolled participants who completed assessments on intervention acceptability immediately following completion of intervention.|||units on a scale||Standard Deviation|Mean
2632250|NCT01837719|Primary|Maximum Observed Plasma Concentration (Cmax) of Atazanavir|Blood samples for plasma concentrations were obtained at predose and at specific timepoints up to 48 hours after dosing on Days 1, 8, 15, 22, and 29. Cmax was derived from plasma concentration versus time data.|Days 1, 8, 15, 22, and 29 (predose and at 1, 2, 2.5, 3, 4, 5, 6, 8, 12, and 16 hours postdose); Days 2, 9, 16, 23, and 30 (24, 30, and 36 hours postdose); Days 3, 10, 17, 24, and 31 (48 hours postdose)|All participants who received any study medication and had any available concentration-time data. All available derived pharmacokinetic (PK) parameter values were included in the PK data set and reported, but only those with adequate PK profiles were included in the summary statistics and statistical analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2632251|NCT01837680|Secondary|Neonatal Hypoglycemia|Number of participants with incidence of blood sugar <40mg/dl in neonate|at birth, up to 41 weeks||||Participants|||Count of Participants
2632252|NCT01837680|Secondary|Polyhydramnios|Incidence of polyhydramnios (defined as amniotic fluid index (AFI)>20 or deepest vertical pocket ≥8) - data not collected|at each visit in pregnancy up to 41 weeks|||||||
2632253|NCT01837680|Secondary|Shoulder Dystocia|Incidence of shoulder dystocia - data not collected|at birth, up to 41 weeks|||||||
2632254|NCT01837680|Secondary|Birth Rate|Number of live birth rate|at birth, up to 41 weeks||||Participants|||Count of Participants
2632255|NCT01837680|Secondary|Delivery Mode|method of delivery including cesarean section, vaginal delivery, or assisted vaginal delivery - data not collected|at birth, up to 41 weeks|||||||
2632256|NCT01837680|Secondary|Intensive Care Admissions|Number of participants with incidence of neonatal intensive care unit admissions|at birth, up to 41 weeks||||Participants|||Count of Participants
2632257|NCT01837680|Secondary|Neonatal Bilirubin|Percentage of neonatal hyperbilirubinemia - data not collected|at birth, up to 41 weeks|||||||
2632258|NCT01837680|Secondary|Maternal Hypoglycemia|Number of participants with incidence of maternal hypoglycemia (<60mg/dl)|at delivery, up to 41 weeks||||Participants|||Count of Participants
2632259|NCT01837680|Secondary|Gestational Age at Delivery|Gestational age at delivery|at delivery, up to 41 weeks||||weeks||Inter-Quartile Range|Median
2632260|NCT01837680|Secondary|Neonatal Weight|Neonatal weight was estimated for occurrence of neonatal macrosomia (≥4000g birth weight) and neonatal LGA(large for gestational age)(birth weight >90th percentile for gestational age|At delivery, up to 41 weeks||||g||Inter-Quartile Range|Median
2632261|NCT01837680|Secondary|Weight Gain|Total weight gain in pregnancy|Number of pounds gained at each visit up to 41 weeks||||lbs||Standard Deviation|Mean
2632262|NCT01837680|Secondary|Post-prandial Blood Glucose|Mean post-prandial blood glucose in pregnancy, as defined as the sum of the average post-prandial blood glucose at each visit divided by the number of visits.|up to 41 weeks||||mg/dL||Standard Deviation|Mean
2632263|NCT01837680|Secondary|Average Fasting Glucose|Mean fasting blood glucose in pregnancy, as determined by the sum of the mean fasting glucose at each visit divided by the number of visits|up to 41 weeks||||mg/dL||Standard Deviation|Mean
2632264|NCT01837680|Secondary|Time to Achieve Glycemic Control|Time (weeks) to achieve glycemic control, as defined as mean glucose <100mg/dl|up to 41 weeks||||weeks||Full Range|Median
2632265|NCT01837680|Secondary|Number of Patients Obtaining Glycemic Control|Number of each group that obtains glycemic control, defined as mean glucose <100mg/dl.|up to 41 weeks||||Participants|||Count of Participants
2632266|NCT01837680|Primary|Glycemic Control|Overall mean glucose value of pregnancy. This will be determined by the sum of average glucose value at each visit, divided by the number of visits.|up to 41 weeks||||mg/dL||Standard Deviation|Mean
2632267|NCT01837654|Secondary|Severity of the Urgency by a 0-10 Visual Analogue Scale (VAS).|Following each wave, patients will be asked to grade the severity of the urgency by a 0 (minimum) to 10 (maximum) visual analogue scale (VAS).|through test completion, an average of 10 minutes||||units on a scale||Standard Error|Mean
2632268|NCT01837654|Primary|Mean Peak Detrusor Pressures|Mean peak detrusor pressures of each contraction|through test completion, an average of 10 minutes||||cm H2O||Standard Deviation|Mean
2632269|NCT01837550|Secondary|Communication Strategies Scale (CSS)|CSS is designed to analyze participants' behavior in various communication situations. Scoring for CSS ranges from 1 almost never to 5 almost always for subscales Verbal- and Nonverbal Strategies and conversely for Maladaptive Behaviors; indicating how frequent a specific situation or behavior occurs. Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 125.|5 weeks, 6 months||||units on a scale||Standard Deviation|Mean
2632270|NCT01837550|Secondary|Hospital Anxiety and Depression Scale (HADS)|The HADS contains 14 items. Responses are scored from 0 to 3 and a higher score indicates more symptoms of anxiety and depression. Minimum score for the total scale (reported) is 0 and maximum score for the total scale is 42.|5 weeks, 6 months||||units on a scale||Standard Deviation|Mean
2632271|NCT01837550|Secondary|International Outcome Inventory for Hearing Aids (IOI-HA)|The IOI-HA measures hearing aid outcomes. The IOI-HA includes seven questions, measuring specific dimensions of hearing aid outcomes: daily use, benefits, remaining activity limitations, satisfaction, remaining participation restrictions, impact on the environment, and quality of life. Each question is scored from 1 to 5 (reported), where a higher score indicates a better outcome.|pre-measurement|The IOI-HA was used only at the pre-masurement point, to select descriptive data about the participants.|||units on a scale||Standard Deviation|Mean
2632272|NCT01837550|Primary|The Hearing Handicap Inventory for the Elderly (HHIE)|The HHIE measures the experience of hearing loss in older people by focusing on the psycosocial and emotional effects of hearing loss. Higher score reflects a higher self-reported hearing problem. Minimum score for the total scale (reported) is 0 and maximum score is 100 points.|5 weeks, 6 months||||units on a scale||Standard Deviation|Mean
2632312|NCT01836445|Secondary|Mean Score of Feelings of HIV Invulnerability at Baseline and 12 Months|"The change in effect that HIV testing has on health beliefs (for example, I cannot get HIV) and sexual behaviors at twelve months. Range 1-5; higher scores = more feelings of invulnerability"|Baseline, 12 Months|Enrolled participants who completed assessments on HIV invulnerability at baseline and 12 month.|||units on a scale||Standard Deviation|Mean
2633525|NCT01823679|Secondary|Progression-free Survival (PFS) at 2 Years|Proportion of participants with progression-free survival (PFS) at 2 years, as calculated based on Kaplan-Meier estimates.|2 years||||percentage of participants|||Number
2632273|NCT01837537|Secondary|Mean Error (ME) +/- 1 Breath Per Minute, Max-N Sensor|The software calculates respiration rate values via the Max-N Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the Respiration Rate calculated from capnography). The error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the Max-N sensor minus the Respiration Rate calculated from capnography.|up to 40 minutes of continuous monitoring|90 subjects were enrolled. Out of the 90 enrolled 75 yielded valid data. The remaining 15 subjects did not meet the predetermined data criteria (such as reference was too noisy, timing of observations could not be matched, etc.)|||BrPM||Standard Deviation|Mean
2632274|NCT01837537|Primary|Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor|The software calculates respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference. The Mean Error value estimates the mean difference in simultaneous estimates of respiration rate (the Respiration Rate calculated from the sensor and the Respiration Rate calculated from capnography).|up to 40 minutes of continuous monitoring|90 subjects were enrolled. Out of the 90 enrolled 75 yielded valid data. The remaining 15 subjects did not meet the predetermined data criteria (such as reference was too noisy, timing of observations could not be matched, etc.)|||BrPM (breaths per minute)||Standard Deviation|Mean
2632275|NCT01837524|Other Pre-specified|Member Self-efficacy and Confidence in Food Purchasing Decisions|Will be assessed using a brief survey at baseline (scored) and re-surveyed after the intervention. Survey questions are based on similar items from other studies of health behavior interventions.|3 months|||||||
2632276|NCT01837524|Other Pre-specified|Cost of Grocery Shopping for Members|Receipts from a typical week's worth of grocery shopping will be collected from all participants at baseline. Then, the same process will be repeated each month during the intervention phase to see what effect participation has on costs of grocery shopping for participants (e.g. if buying more produce because shopping with dietitian - will shopping be more expensive?)|3 months|||||||
2632277|NCT01837524|Secondary|Nutritional Knowledge of Members|A modified version of the Parmenter-Wardle Nutrition Knowledge Questionnaire (1999, UK) has been created based on present-day guidelines and eating patterns in the Southeast U.S., and will be administered at baseline and scored, then re-administered after the intervention and re-scored to determine whether or how the score improved after the intervention with the dietitian.|3 months|||||||
2632278|NCT01837524|Primary|Change in Dietary Quality Scores of Members as Measured Using the 2005 Healthy Eating Index (HEI).|"The Block FFQ will be administered at baseline in order to calculate a participant's baseline HEI score, and will be re-administered after the 3 month intervention to re-calculate the post-intervention HEI score.~The numbers reported here represent the change from pre to post intervention, in the HEI scores for participants in each group~HEI scores can range from 0 to 100, with 0 representing the least overall healthy diet, and 100 representing the most overall healthy diet. There are no units associated with the HEI score. The measure was developed by the US Dept of Agriculture and complete details regarding its development can be found on their website."|3 months||||points||Standard Deviation|Mean
2632279|NCT01836809|Secondary|Total Diuretic Requirement||46 Hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm||||||
2632280|NCT01836809|Secondary|Time to Renal Failure||46 Hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm||||||
2632281|NCT01836809|Secondary|Urine Output||46 Hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm||||||
2632282|NCT01836809|Secondary|Need for Hemodialysis/Renal Replacement Therapy||90 days|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm||||||
2632283|NCT01836809|Primary|Renal Plasma Flow||46 Hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm||||||
2632284|NCT01836809|Primary|Glomerular Filtration Rate||46 hours|Analysis not done as study was closed early due to futility of reaching enrollment goals in the Total Artificial Heart arm||||||
2632285|NCT01836549|Secondary|Quantitative MRI Parameters of Tumors Prior to and After Treatment With Imetelstat (Molecular Biology and Phase II Studies)|This outcome measure was for both Molecular biology and Phase II studies. We will not be able to present the results of this objective as the study was terminated early.|Up to 30 days|This study has been terminated early and the study team decided not to pursue this aim as the results would be inconclusive due to small sample size. Neither the neuroimaging, nor the biology data are available for these patients.||||||
2632286|NCT01836549|Secondary|Number of Patients With Telomerase Expression Data by Detection of hTERT mRNA and TERC RNA Levels by qRT-PCR and Telomerase Activity by TRAP in Archival Tumor Tissue and to Explore Association of Telomerase Positivity With Objective Response and PFS|This secondary objective is for Stratum-B and C only, which enroll HGG and ependymoma patients. We will describe the evidence of telomerase expression by detection of hTERT mRNA and TERC RNA levels by qRT-PCR and telomerase activity by TRAP in archival tumor tissue; Association of telomerase positivity with objective response and PFS will not be able to be conducted as the study was terminated early and there was no objective response.|Up to 30 days. Due to small number of patients evaluable for this objective, we can only provide number of patients with the targetted markers as no analysis with PFS is possible.|This objective is for STRATUM-C patients only, having only 4 patients with TRAP, TERT and TERC levels measured. Due to small sample and having no objective response, association studies of these markers with Objective Reponse and PFS were not possible. Therefore, we only report the the percentage of cases with at least weak TRAP activity.|||Participants|||Count of Participants
2632338|NCT01836133|Secondary|Percentage of Participants With Overall Response|Overall response was defined, based on response evaluation criteria in solid tumours (RECIST) v 1.1, as complete response (CR) plus partial response (PR). CR: complete disappearance of all target lesions; PR: at least 30% decrease in the sum of the longest diameter of all target lesions taking as reference the baseline sum of all target lesions.|Approximately 3 years|The effectiveness analysis population included all enrolled participants in the study.|||Percentage of participants||95% Confidence Interval|Number
2632287|NCT01836549|Secondary|Stratum-specific Progression-free Survival (PFS) (Phase II)|Kaplan-Meier estimates of distributions of survival and PFS for all eligible subjects who received at least one dose of imetelstat will be provided separately.|Up to 2 years, from the date of initial treatment to the earliest date of disease progression, second malignancy or death for subjects who fail; and to the date of last contact for subjects who remain at risk for failure, assessed up to 3 years|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|||days||Standard Error|Mean
2632288|NCT01836549|Secondary|Number of Participants With Telomerase Inhibition|This outcome measure is applicable only for the Molecular biology study arm. Telomerase inhibition was assessed in PBMCs and summarised as 'yes-inhibited' vs. 'no inhibition'|Up to 30 days|Samples from six patients were consequently considered evaluable and were analyzed.|||Participants|||Count of Participants
2632289|NCT01836549|Primary|Phase II: Stratum-specific Objective Response (CR+PR) Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=50% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR sustained for at least 6 weeks.~For each stratum separately exact confidence interval estimates will be provided for the true, unknown rates of objective response. Estimated by cumulative incidence functions."|6 months|This is the Phase-II study cohort, excluding the molecular study patients.|||Participants|||Count of Participants
2632290|NCT01836549|Primary|Numver of Patients With Telomerase-positive Archival Tumors Who Demonstrate at Least 50% Reduction|This outcome measure is for the Molecular biology study only. The assessment was done to identify cases with at least 50% reduction in telomerase activity.|Up to 30 days|This outcome measure is only for the molecular biology study. Telomerase inhibition was assessed and the inhibition level was compared with the baseline level to identify increased inhibition.|||Participants|||Count of Participants
2632291|NCT01836523|Secondary|Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes|This is a confirmatory secondary endpoint. Symptomatic hypoglycaemic episodes were defined as: 1) Severe according to the American Diabetes Association (ADA) classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. OR 2) Self-monitoring of plasma glucose value of <3.1 mmol/L, with symptoms consistent with hypoglycaemia. A treatment emergent episode is defined as an episode with onset date (or increase in severity) on or after first day of exposure to randomised treatment and up to last dose + 7 days.|Weeks 0-52|The safety analysis set included all randomised subjects exposed to at least one dose of liraglutide or placebo.|||episodes|||Number
2632292|NCT01836523|Primary|Change From Baseline in Total Daily Insulin Dose|Change from baseline in total daily insulin dose at week 52. Change from baseline was represented in terms of ratio to baseline for insulin dose i.e. Total daily insulin dose at week 52/total daily insulin dose at baseline. Missing values were handled by using a MMRM.|Week 0, week 52|Full analysis set. Number of subjects analysed=subjects with any post-baseline total insulin daily dose data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2632293|NCT01836523|Primary|Change From Baseline in Body Weight|Change from baseline in body weight at week 52. Missing values were handled by using a MMRM.|Week 0, week 52|Full analysis set. Number of subjects analysed=subjects with any post-baseline body weight data.|||kg||Standard Deviation|Mean
2632294|NCT01836523|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c at week 52. Missing values were handled by using a mixed model for repeated measurements (MMRM).|Week 0, week 52|Full analysis set. Number of subjects analysed=subjects with any post-baseline HbA1c data.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2632295|NCT01836471|Secondary|Change From Baseline in ACQ-6 Score at Week 12 Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set|ACQ-6 consists of:5 items on symptoms, 1 item on rescue bronchodilator use, and 1 item on airway caliber (FEV1 % predicted). The ACQ was fully validated, including a minimal important difference (MID) or smallest change that could be considered clinically important (0.5). The ACQ was self-administered at the clinic and patients scored each item on a 7-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled.' Study staff scored question 7 based on % predicted FEV1 (ideally pre-bronchodilator). The total score=average of first 6 questions. Baseline=the ACQ-6 measurement taken prior to first dose of randomized study drug. The single missing score was interpolated by utilizing prior or subsequent completions of the questionnaire. Estimates were from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline ACQ-6 and region as fixed effects and center nested within region as random effects.|baseline,12 weeks||||score||Standard Error|Least Squares Mean
2632296|NCT01836471|Secondary|Change From Baseline in ACQ-6 Score at Week 12 Non-atopic and Atopic Patients at Week 12 - Full Analysis Set|ACQ-6 consists of:5 items on symptoms, 1 item on rescue bronchodilator use, and 1 item on airway caliber (FEV1 % predicted). The ACQ was fully validated, including a minimal important difference (MID) or smallest change that could be considered clinically important (0.5). The ACQ was self-administered at the clinic and patients scored each item on a 7-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled.' Study staff scored question 7 based on % predicted FEV1 (ideally pre-bronchodilator). The total score=average of first 6 questions. Baseline=the ACQ-6 measurement taken prior to first dose of randomized study drug. The single missing score was interpolated by utilizing prior or subsequent completions of the questionnaire. Estimates were from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline ACQ-6 and region as fixed effects and center nested within region as random effects.|baseline,12 weeks||||score||Standard Error|Least Squares Mean
2632313|NCT01836445|Secondary|Mean Score of Health Protective Communication Skills at Baseline and 12 Months|The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at twelve months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).|Baseline, 12 Months|Enrolled participants who completed assessments on health protective communication (HPC) Relationship & condom items: must have reported vaginal/anal sex partner in prev. 3 months at both time points HIV testing items: must have reported NEW vaginal/anal sex partner in prev. 3 months at both time points Higher score = less HPC skills; range 1-4|||units on a scale||Standard Deviation|Mean
2632297|NCT01836471|Secondary|Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the FEV1 measurement taken prior to the first dose of randomized study drug.~Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).~Estimates are from a mixed effects model with treatment, subject population, treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug."|baseline,12 weeks||||liter||Standard Error|Least Squares Mean
2632298|NCT01836471|Secondary|Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the FEV1 measurement taken prior to the first dose of randomized study drug.~Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).~Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug."|baseline,12 weeks||||liter||Standard Error|Least Squares Mean
2632299|NCT01836471|Primary|Change From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set|"Forced Expiratory Volume in one second (FEV1) is calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. Baseline is defined as the last available FEV1 measurement taken prior to the first dose of randomized study drug.~Data within 6 hr of rescue medication use is excluded from this analysis. For subjects with missing trough FEV1 (L) at Week 12, the last post baseline observation were used (LOCF).~Estimates are from a mixed effects model with treatment, subject population (non-atopic vs. atopic), treatment by subject population interaction, baseline trough FEV1 and region as fixed effects and center nested within region as random effects. Full analysis set included all randomized subjects who received at least one dose of study drug."|baseline,12 weeks||||liter||Standard Error|Least Squares Mean
2632300|NCT01836458|Secondary|Percentage of Patients PCR-corrected Cure Rate by Day 28, Day 35 & Day 42|PCR-corrected cure rate after a single dose of KAE609 by Day 28, Day 35 & Day 42. PCR-corrected cure rate accounts for failures due to reappearance of parasites that were present in the blood before treatment (i.e. recrudescent infection) but not for failures due to a post-treatment inoculation (i.e. new infection).|Day 28, Day 35 & Day 42|Pharmacodynamic Analysis Set includes all enrolled patients.|||Percentage of Patients|||Number
2632301|NCT01836458|Secondary|Median Time to Fever Clearance|Fever is monitored on participants every 4 hours for the first 24 hours, then every 6 hours until negative reading obtained.|Day 1 to Day 5|Pharmacodynamic Analysis Set includes all enrolled patients|||hours||90% Confidence Interval|Median
2632302|NCT01836458|Secondary|Median Time to Parasite Clearance|Parasite clearance time will be estimated using thick/thin blood films.|pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48, 54, 60, 66, 72 hours post dose of KAE609|Pharmacodynamic Analysis Set includes all enrolled patients|||hours||95% Confidence Interval|Median
2632303|NCT01836458|Primary|Minimum Inhibitory Concentration (MIC) of KAE609|To observe the exposure-response (PK/PD) relationship for a single dose of KAE609. The key parameter is MIC, defined as the concentration at which the relative rate of change in parasitemia is equal to zero. Approximation of MIC will assist in identifying the optimal dose of KAE609, which will be one component of a future combination antimalarial. MIC could not be determined due to small sample size no data was collected from any participants.|Up to Day 8 after a single dose of KAE609|The primary Outcome Measure (OM) could not be determined due to small sample size no data was collected from any participants.||||||
2632304|NCT01836445|Other Pre-specified|Level of Privacy|Log of the levels of privacy of the locations where participants completed intervention.|Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)|Participants who reported information about the locations where they completed the intervention sessions.|||Participants|||Count of Participants
2632305|NCT01836445|Other Pre-specified|Occurrence of Sexually Transmitted Infections (STIs) at 6 Months|The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at 6 month follow-up. Only measured for participants who initially tested positive for chlamydia or gonorrhea at baseline.|6 Months|Participants who were positive for an STI at baseline, were sent a follow-up test kit at 6 Month Follow-up, and tested positive again.|||Participants|||Count of Participants
2632306|NCT01836445|Other Pre-specified|Occurrence of Sexually Transmitted Infections (STIs) at 3 Months|The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at 3 month follow-up. Only measured for participants who initially tested positive for chlamydia or gonorrhea at baseline.|3 Months|Participants who were positive for an STI at baseline, were sent a follow-up test kit at 3 Month Follow-up, and tested positive again.|||Participants|||Count of Participants
2632307|NCT01836445|Other Pre-specified|Participant Experiences of Harm at 12 Month Follow-up|Log of any negative experiences or harm experienced by participant at twelve months.|12 Months|Number of participants who reported negative health experiences at 12 Month Follow-up as a result of participating in the study|||Participants|||Count of Participants
2632308|NCT01836445|Other Pre-specified|Participant Experiences of Harm at 6 Month Follow-up|Log of any negative experiences or harm experienced by participant at six months.|6 Months|Number of participants who reported negative health experiences at 6 Month Follow-up|||Participants|||Count of Participants
2632309|NCT01836445|Other Pre-specified|Participant Experiences of Harm at 3 Month Follow-up|Log of any negative experiences or harm experienced by participant at three months.|3 Months|Number of participants who reported negative health experiences at 3 Month Follow-up|||Participants|||Count of Participants
2632310|NCT01836445|Other Pre-specified|Participant Location|Log of where participants completed the intervention sessions (participants can select multiple locations).|Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)|Participants who reported information about the locations where they completed the intervention sessions.|||Participants|||Count of Participants
2632314|NCT01836445|Secondary|Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months|"At twelve months, the change in:~Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer)~Social Norms (for example, partners, friends, or family members opinions about condom use)~Behavioral Skills (for example, negotiating condom use)~Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4"|Baseline, 12 Months|Enrolled participants who completed assessments on motivation & behavioral skills at baseline and 12 month.|||units on a scale||Standard Deviation|Mean
2632315|NCT01836445|Secondary|Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 12 Months|"The change in number of HIV statements (e.g. Only the receptive/bottom partner is at risk of being infected with HIV during anal sex, There is a vaccine that can stop people from getting HIV, and A natural skin (lamb skin) condom works better against HIV than does a latex condom) correctly labeled as true or false at twelve months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk."|Baseline, 12 Months|Enrolled participants who completed assessments on their HIV Knowledge at baseline and 12 month follow-up.|||percentage of correct responses||Standard Deviation|Mean
2632316|NCT01836445|Secondary|Mean Score of Condom Errors at Baseline and 12 Months|The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at twelve months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors.|Baseline, 12 Months|Enrolled participants who completed assessments on their condom errors at baseline and 12 month follow-up.|||units on a scale||Standard Deviation|Mean
2632317|NCT01836445|Secondary|Mean Score of Health Protective Communication Skills at Baseline and 6 Months|The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at six months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).|Baseline, 6 Months|Enrolled participants who completed assessments on health protective communication (HPC) Relationship & condom items: must have reported vaginal/anal sex partner in prev. 3 months at both time points HIV testing items: must have reported NEW vaginal/anal sex partner in prev. 3 months at both time points|||units on a scale||Standard Deviation|Mean
2632318|NCT01836445|Secondary|Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months|"At six months, the change in:~Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer)~Social Norms (for example, partners, friends, or family members opinions about condom use)~Behavioral Skills (for example, negotiating condom use)~Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4"|Baseline, 6 Months|Enrolled participants who completed assessments on motivation & behavioral skills at baseline and 6 month.|||units on a scale||Standard Deviation|Mean
2632319|NCT01836445|Secondary|Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 6 Months|"The change in number of HIV statements (e.g. Only the receptive/bottom partner is at risk of being infected with HIV during anal sex, There is a vaccine that can stop people from getting HIV, and A natural skin (lamb skin) condom works better against HIV than does a latex condom) correctly labeled as true or false at six months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk."|Baseline, 6 Months|Enrolled participants who completed assessments on HIV Knowledge at baseline and 6 month.|||percentage of correct responses||Standard Deviation|Mean
2632320|NCT01836445|Secondary|Mean Score of Condom Errors at Baseline and 6 Months|The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at six months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors|Baseline, 6 Months|Enrolled participants who completed assessments on condom errors at baseline and 6 month.|||units on a scale||Standard Deviation|Mean
2632321|NCT01836445|Secondary|Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months|The change in number of participants who report using illegal drugs or drugs not prescribed by a doctor before sex.|Baseline, 12 Month|Enrolled participants who completed assessments on drug use before sex at baseline and 12 month.|||Participants|||Count of Participants
2632322|NCT01836445|Secondary|Mean Score of Health Protective Communication Skills at Baseline and 3 Months|The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at three months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).|Baseline, 3 Months|Enrolled participants who completed assessments on health protective communication (HPC) Relationship & condom items: must have reported vaginal/anal sex partner in prev. 3 months at both time points HIV testing items: must have reported NEW vaginal/anal sex partner in prev. 3 months at both time points|||units on a scale||Standard Deviation|Mean
2632323|NCT01836445|Secondary|Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months|"At three months, the change in:~Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer)~Social Norms (for example, partners, friends, or family members opinions about condom use)~Behavioral Skills (for example, negotiating condom use)~Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4"|Baseline, 3 Months|Enrolled participants who completed assessments on motivation & behavioral skills at baseline and 3 month.|||units on a scale||Standard Deviation|Mean
2632339|NCT01836133|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from initial dose of erlotinib to progression or death from any cause.|Approximately 3 years|The effectiveness analysis population included all enrolled participants in the study.|||months||95% Confidence Interval|Median
2633526|NCT01823679|Secondary|Progression-free Survival (PFS) at 1 Year|Proportion of participants with progression-free survival (PFS) at 1 year, as calculated based on Kaplan-Meier estimates.|1 year||||percentage of participants|||Number
2632324|NCT01836445|Secondary|Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 3 Months|"The change in number of HIV statements (e.g. Only the receptive/bottom partner is at risk of being infected with HIV during anal sex, There is a vaccine that can stop people from getting HIV, and A natural skin (lamb skin) condom works better against HIV than does a latex condom) correctly labeled as true or false at three months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk."|Baseline, 3 Months|Enrolled participants who completed assessments on HIV knowledge at baseline and 3 month follow-up.|||percentage of correct responses||Standard Deviation|Mean
2632325|NCT01836445|Secondary|Mean Score of Condom Errors at Baseline and 3 Months|The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at three months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors.|Baseline, 3 Months|Enrolled participants who completed assessments on condom errors at baseline and 3 month follow-up.|||units on a scale||Standard Deviation|Mean
2632326|NCT01836445|Primary|Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months|The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at twelve months.|12 months|"Enrolled participants who returned STI test kits for analysis at 12 month follow-up.~Denominator varies by testing site and study arm: urethral (control - 374; intervention - 359) rectal (control - 374; intervention - 356)"|||Participants|||Count of Participants
2632327|NCT01836445|Primary|Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline|The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at baseline.|Baseline|Enrolled participants who returned STI test kits for analysis at baseline. Denominator varies by testing site and study arm: urethral (control - 452; intervention - 441) rectal (control - 449; intervention - 442)|||Participants|||Count of Participants
2632328|NCT01836445|Primary|Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months|Change in self-report of condomless anal sex acts at twelve months.|Baseline, 12 Months|Enrolled participants who completed assessments on their sexual risk behaviors (e.g. condomless anal sex (CAS) acts) at baseline and 12 month follow-up.|||Participants|||Count of Participants
2632329|NCT01836445|Primary|Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months|Change in self-report of condomless anal sex acts at six months.|Baseline, 6 Months|Enrolled participants who completed assessments on their sexual risk behaviors (e.g. condomless anal sex (CAS) acts) at baseline and 6 month follow-up.|||Participants|||Count of Participants
2632330|NCT01836445|Primary|Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months|Change in self-report of condomless anal sex acts at three months.|Baseline, 3 Months|Enrolled participants who completed assessments on their sexual risk behaviors (e.g. condomless anal sex (CAS) acts) at baseline and 3 month follow-up.|||Participants|||Count of Participants
2632331|NCT01836276|Primary|Number of Participants With Cotinine-verified 7-day Point Prevalence Smoking Abstinence at Week 26|Defined as having no cigarettes for the previous 7 days at the Week 26 visit. The recommended cut-off of 15ng/ml for salivary cotinine will be used to differentiate smokers from non-smokers.|Change from Baseline to Week 26||||Participants|||Count of Participants
2632332|NCT01836198|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021||Predose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 216, and 336 hours postdose (and 408, 504, and 576 hours postdose in Part A, Period 2 and Part B only)|All participants who received at least 1 dose of study drug and had evaluable Cmax data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2632333|NCT01836198|Primary|Pharmacokinetics: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of LY2409021||Predose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 216, and 336 hours postdose (and 408, 504, and 576 hours postdose in Part A, Period 2 and Part B only)|All participants who received at least 1 dose of study drug and had evaluable AUC(0-∞) data.|||nanogram*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2632334|NCT01836185|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib||Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose|Participants who received at least one dose of study drug and had evaluable PK data.|||h||Full Range|Mean
2632335|NCT01836185|Primary|PK: Maximum Observed Concentration (Cmax) of Evacetrapib||Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose|Participants who received at least 1 dose of study drug and had evaluable PK (Cmax) data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2632336|NCT01836185|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC0-tlast) of Evacetrapib|tlast is defined as the last time point with a measurable concentration of Evacetrapib.|Predose on Day 1, and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours after the Day 1 dose|Participants who received at least 1 dose of study drug and had evaluable PK (AUC0-tlast) data.|||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2632337|NCT01836133|Secondary|Proportions of Participants With Adverse Events (AEs), Serious AEs, and AEs of Special Interest (AESIs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant, according to national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) criteria version 4.0. An AESI was defined as interstitial pulmonary disease.|Baseline up to 3 years|The safety analysis population included all enrolled participants who received a single dose of erlotinib.|||Proportion of participants||95% Confidence Interval|Number
2633527|NCT01823679|Primary|Objective Response Rate (ORR)|Response assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|9 weeks (3 cycles)||||percentage of participants|||Number
2632343|NCT01836029|Secondary|Comparison of Adverse Events (AEs) Between the Two Treatment Groups.|The frequency and severity of adverse events, including any clinically significant changes in physical exam, laboratory values, or other clinical assessment.|AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. Overall mean duration of exposure was 25.3 weeks.|Safety population: subjects who received at least 1 dose of VTX-2337 or placebo.|||percentage of participants|||Number
2632344|NCT01836029|Primary|Comparison of Progression Free Survival (PFS) Between Treatment Groups Using irRECIST and Evaluated by Independent Radiology.|PFS was based on central assessment by a blinded independent radiologist per immune related response evaluation criteria for solid tumors (irRECIST) and was summarized and displayed by treatment arm using Kaplan-Meier methods. Treatments were compared using a stratified log-rank test controlling for randomization stratification factors. The hazard ratio between the 2 treatment arms, as well as the associated one-sided 90% CI and p-value, were presented using a Cox proportional hazards regression model.|PFS is the time from randomization until disease progression or death, whichever comes first.|ITT population|||days||90% Confidence Interval|Median
2632345|NCT01835912|Other Pre-specified|Rate of Perceived Exertion|"Rate of perceived exertion (RPE) was recorded after each 200 metre swimming performance~RPE scale is from 6-20. Minimum = 6 (level of exertion equal to lying down) and Maximum = 20 (maximal perceived exertion)~Numbers reported are the average of the RPE recorded for all 10 participants."|Rate of Perceived Exertion after each 200m swimming performance||||units on a scale (6-20)||Standard Error|Mean
2632346|NCT01835912|Secondary|Lactate|lactate measured at 3min post trial|3 min post performance||||mmol/L||Standard Error|Mean
2632347|NCT01835912|Primary|Time|"time to complete 200 metre swimming performances in seconds~Participants chose type of swim stroke to swim a maximal effort 200 metre performance"|once each 200m performance||||seconds||Standard Error|Mean
2632348|NCT01835899|Secondary|AUCt,ss|Area under the concentration-time curve of BI 1015550 in plasma at steady state over a uniform dosing interval t.|311:55h; 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h and 324h after first drug administration; last drug administration was at 312 h.|PK set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2632349|NCT01835899|Secondary|Cmax,ss|Maximum measured concentration of BI 1015550 in plasma at steady state over a uniform dosing interval t.|311:55h (hours); 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h; 324h; 336h; 346h; 360h; 384h & 408h after first drug administration; last drug administration was at 312 h.|PK set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2632350|NCT01835899|Secondary|AUC0-infinity|Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity.|0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.|PK set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2632351|NCT01835899|Secondary|AUCt,1|Area under the concentration-time curve of BI 1015550 in plasma over a uniform dosing interval t after administration of the first dose|0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h and 12h after first drug administration|PK set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2632352|NCT01835899|Secondary|Cmax|Maximum measured concentration of BI 1015550 in plasma.|0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.|The PK analysis set (PKS) included all subjects of the TS who provided at least 1 observation for at least 1 secondary PK endpoint and who did not have a protocol violation relevant to the evaluation of PK.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2632353|NCT01835899|Primary|Percentage of Subjects With Drug-related Adverse Events|Percentage of subjects with drug related Adverse events, as assessed by the investigator.|From first drug administration until last drug administration, upto 18 days.|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least one dose of investigational treatment.|||Percentage of participants|||Number
2632354|NCT01835756|Secondary|Satisfaction With Study Outcome|"At study endpoint, the subject was asked to rate how satisfied he or she was with any overall change in low back pain attained following the procedure administration phase with the Erchonia MLS Laser, using the following five-point scale:~Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied~Results are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome."|4 Months||||participants|||Number
2632355|NCT01835756|Secondary|Change in Low Back Pain Visual Analog Scale (VAS) Score|The VAS is a straight line scale that is marked on one end with a '0' for 'no pain' and at the other end with '100' for 'worse pain imaginable.' A higher score on the VAS indicates a greater level of pain, and a lower score indicates a lower level of pain.A decrease in the VAS pain rating indicates a reduction in low back pain and is positive for study success. An increase in the VAS pain rating indicates a worsening of low back pain and is negative for study success. The mean change in low back pain score recorded on the Visual Analog Scale (VAS) from baseline to 4 months post-procedure was calculated for each treatment group.|Baseline and 4 Months||||units on a scale||Standard Deviation|Mean
2632356|NCT01835756|Primary|Difference in the Proportion of Primary Outcome Successes Between Treatment Groups|Primary outcome success for an individual subject was defined as a 30% or greater change (decrease) in VAS pain score at 4 months post-procedure relative to baseline. The VAS is a straight line scale that is marked on one end with a '0' for 'no pain' and at the other end with '100' for 'worse pain imaginable.' A higher score indicates a greater level of pain, and a lower score indicates a lower level of pain. A negative (-) percent change in VAS rating indicates a decrease in pain level and is positive for individual subject success. A positive (+) percent change indicates an increase in pain level and is negative for individual subject success. Overall study success was defined as a 35% or greater difference in the proportion of individual primary outcome successes in each treatment group, in favor of the active treatment group.|4 Months||||participants|||Number
2632475|NCT01834586|Primary|Pain Rating|"Primary Outcome Measure~•Change from baseline in rating of pain upon injection, recorded immediately post-injection on a 0-10 Visual Analog Scale (VAS, 10 = worst pain, 0 = no pain)Pain upon injection, recorded immediately post-injection on a 0-10 Visual Analog scale (VAS, 10 = worst pain, 0 = no pain)."|baseline and two weeks of treatment|completing participants|||units on a scale||Standard Deviation|Mean
2632357|NCT01835743|Secondary|Change in Heel Pain Score on the Visual Analog Scale (VAS)|Each subject rated heel pain upon taking the first few steps of the day on the 0-100 mm (0 -10 cm) Visual Analog Pain Scale (VAS) from '0: no pain at all' to '100: worst pain imaginable'. The higher the VAS score, the greater the heel pain experienced. Change in heel pain score on the VAS was calculated as the heel pain VAS score at week 5 (2 weeks after procedure administration end) minus the heel pain VAS score at baseline evaluation. A negative (-) change in heel pain VAS score across the evaluation period indicated a decrease (improvement) in heel pain and was positive for study success. A positive (+) change in heel pain VAS score indicated an increase (worsening) in heel pain and was negative for study success.|baseline and 5 weeks||||scores on a 0-100 VAS scale||Standard Deviation|Mean
2632358|NCT01835743|Primary|Number of Participants Who Attained a Change of -30% or Greater in the VAS Score|Each subject rated heel pain upon taking the first few steps of the day on the 0-100 mm (0 -10 cm) Visual Analog Pain Scale (VAS) from '0: no pain at all' to '100: worst pain imaginable'. The higher the VAS score, the greater the heel pain experienced. Percent (%) change in VAS score was calculated as the % difference in VAS score at week 5 (2 weeks after procedure administration end) relative to baseline evaluation. A negative (-) % difference in VAS score across the evaluation period indicated a decrease (improvement) in heel pain, and a positive (+) % difference in VAS score indicated an increase (worsening) in heel pain. A change of -30% or greater in the VAS score was considered positive for study success. The number of participants who attained a change of -30% of greater in VAS score across the evaluation period was calculated for both subjects in the test group and in th placebo group as a proportion of the total number of subjects in each procedure group.|baseline and 5 weeks||||participants|||Number
2632359|NCT01835587|Secondary|Kaplan Meier Estimate of Relapse-Free Survival (RFS)|Relapse-free survival was defined as the interval from the date of allogeneic HSCT to the date of first documented > 5% blasts in the bone marrow or death from any cause, whichever occurs first. Participants who were still alive and continued to have less than or equal to 5% blasts in the bone marrow or who were lost to follow-up were censored at the date of their last response assessment.|Date of allogenic HSCT to date of progression or death from any cause; Median number of days participants were assessed from first dose to last contact was 963 days for Cohort 1, 674.8 days for Cohort 2, 577.5 days for Cohort 3A and 553 days for Cohort 3|Preliminary efficacy population includes all participants who received at least 1 dose of IP and had at least 1 post-baseline efficacy assessment performed. Participants who were still alive and continued to have ≤5% blasts in the bone marrow or who were lost to follow-up were censored at the date of their last response assessment.|||Days||Inter-Quartile Range|Median
2632360|NCT01835587|Secondary|Overall Survival|Overall Survival was defined as the time from the date of allogeneic hematopoietic stem cell transplantation to death from any cause.|Date of the allogeneic HSCT to death from any cause. Median number of days participants were assessed from first dose to last contact was 963.0 days for Cohort 1, 743.5 days for Cohort 2, 675.5 days for Cohort 3A and 559.0 days for Cohort 3.|Preliminary efficacy population includes all participants who received at least 1 dose of IP and had at least 1 post-baseline efficacy assessment performed. All participants were followed until drop-out, death, or study closure. Participants who dropped out or were alive at study closure were censored at the time of last contact, as appropriate.|||Days||Inter-Quartile Range|Median
2632361|NCT01835587|Secondary|Time to Disease Recurrence/Progression|Time to disease relapse/progression was defined as the interval from the date of allogeneic HSCT to the date of treatment discontinuation or study discontinuation where reason for discontinuation is disease relapse or disease progression, or the date of disease progression recorded on the survival electronic Case Report Form page, whichever occurred first. Time to disease relapse/progression was analyzed using competing risk methods where death without documented relapse/progression was treated as a competing risk for relapse/progression. relapse/progression.|Date of allogenic HSCT to disease progression or relaopse; up to data cut-off date of 14 July 2017; median number of days assessed was 963.0 days for Cohort 1, 743.5 days for Cohort 2, 675.5 days for Cohort 3A and 559.0 days for Cohort 3.|Preliminary efficacy population included all participants who received at ≥ 1 dose of IP and had at ≥ 1 post-baseline efficacy assessment performed. Participants who were lost to follow-up without documented relapse/progression, or were alive at last follow-up without documented relapse/progression were censored at the date of the last assessment.|||days||Standard Deviation|Mean
2632362|NCT01835587|Secondary|Percentage of Participants With Disease Relapse or Progression|Disease relapse was defined as the reappearance of > 5% blasts in the bone marrow that persists for at least 4 weeks. Disease progression was defined as the reappearance of > 10% of blasts in the bone marrow that persisted for at least 4 weeks.|Date of first dose of IP to disease relapse or progression; up to data cut-off date of 14 July 2017; median number of days assessed was 963.0 days for Cohort 1, 743.5 days for Cohort 2, 675.5 days for Cohort 3A and 559.0 days for Cohort 3.|Preliminary efficacy population included all participants who received at ≥ 1 dose of IP and had at ≥ 1 post-baseline efficacy assessment performed.|||Percentage of Participants|||Number
2632363|NCT01835587|Secondary|Apparent Volume of Distribution (Vz/F) of CC-486|Apparent volume of distribution, calculated as [(CL/F)/λz].Apparent volume of distribution, calculated as [(CL/F)/λz].|On Day 1, PK samples were collected at predose and over the 6-hour period following CC-486 administration on the following schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, and 6 hours post-dose at Cycle 1 or 2 until 6 hours after CC-486 administration.|The PK population were those with evaluable CC-486 plasma PK profiles; PK data from those who received CC-486 200 mg QD were combined because following a single CC-486 dose, the half-life elimination is <1 h; CC 486 does not accumulate following multiple administrations. CC-486 200 mg Days 1-7 and CC-486 200 mg Days 1-14 arms can be combined.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2632364|NCT01835587|Secondary|Apparent Total Clearance (CL/F) of CC-486|Apparent total clearance, calculated as [Dose/AUCinf].|On Day 1, PK samples were collected at predose and over the 6-hour period following CC-486 administration on the following schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, and 6 hours post-dose at Cycle 1 or 2 until 6 hours after CC-486 administration.|The PK population were those with evaluable CC-486 plasma PK profiles; PK data from those who received CC-486 200 mg QD were combined because following a single CC-486 dose, the half-life elimination is <1 h; CC 486 does not accumulate following multiple administrations. CC-486 200 mg Days 1-7 and CC-486 200 mg Days 1-14 arms can be combined.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2633546|NCT01823510|Secondary|Platelet Reactivity|Platelet reactivity by Multiplate Analyzer|up to 7 days||||percentage of baseline Unit||Standard Error|Mean
2632365|NCT01835587|Secondary|Terminal Half-Life (T1/2) of CC-486|Terminal phase half-life in plasma, calculated as [(ln 2)/λz]. t1/2 will only be calculated when a reliable estimate for λz can be obtained.|On Day 1, PK samples were collected at predose and over the 6-hour period following CC-486 administration on the following schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, and 6 hours post-dose at Cycle 1 or 2 until 6 hours after CC-486 administration.|The PK population were those with evaluable CC-486 plasma PK profiles; PK data from those who received CC-486 200 mg QD were combined because following a single CC-486 dose, the half-life elimination is <1 h; CC 486 does not accumulate following multiple administrations. CC-486 200 mg Days 1-7 and CC-486 200 mg Days 1-14 arms can be combined.|||hours||Geometric Coefficient of Variation|Geometric Mean
2632366|NCT01835587|Secondary|Time to Reach Maximum Concentration (Tmax) of CC-486|Time to Cmax, obtained directly from the observed concentration versus time data.|On Day 1, PK samples were collected at predose and over the 6-hour period following CC-486 administration on the following schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, and 6 hours post-dose at Cycle 1 or 2 until 6 hours after CC-486 administration.|The PK population were those with evaluable CC-486 plasma PK profiles; PK data from those who received CC-486 200 mg QD were combined because following a single CC-486 dose, the half-life elimination is <1 h; CC 486 does not accumulate following multiple administrations. CC-486 200 mg Days 1-7 and CC-486 200 mg Days 1-14 arms can be combined.|||hours||Full Range|Median
2632367|NCT01835587|Secondary|Maximum Observed Concentration (Cmax) Of CC-486|Maximum observed plasma concentration, obtained directly from the observed concentration versus time data.|On Day 1, PK samples were collected at predose and over the 6-hour period following CC-486 administration on the following schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, and 6 hours post-dose at Cycle 1 or 2 until 6 hours after CC-486 administration.|The PK population were those with evaluable CC-486 plasma PK profiles; PK data from those who received CC-486 200 mg QD were combined because following a single CC-486 dose, the half-life elimination is <1 h; CC 486 does not accumulate following multiple administrations. CC-486 200 mg Days 1-7 and CC-486 200 mg Days 1-14 arms can be combined.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2632368|NCT01835587|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Extrapolated to Infinity (AUC-inf; AUC0-∞) Of CC-486|Area under the plasma concentration-time curve from time 0 extrapolated to infinity, calculated as [AUCt + Ct/ λz]. Ct is the last quantifiable concentration. No AUC extrapolation was performed with unreliable λz. If AUC %Extrap was ≥25%, AUC inf was not reported.|On Day 1, PK samples were collected at predose and over the 6-hour period following CC-486 administration on the following schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, and 6 hours post-dose at Cycle 1 or 2 until 6 hours after CC-486 administration.|The PK population were those with evaluable CC-486 plasma PK profiles; PK data from those who received CC-486 200 mg QD were combined because following a single CC-486 dose, the half-life elimination is <1 h; CC 486 does not accumulate following multiple administrations. CC-486 200 mg Days 1-7 and CC-486 200 mg Days 1-14 arms can be combined.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2632369|NCT01835587|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration Of CC-486 (AUC-t)|Area under the plasma concentration-time curve from Time 0 to the time of the last quantifiable concentration, calculated by linear trapezoidal method when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|On Day 1, pharmacokinetic (PK) samples were collected at predose and over a 6-hour period following drug administration on the following schedule: 0.5, 1, 1.5, 2, 2.5, 3, 4, and 6 hours post-dose; Cycle 1 or 2 until 6 hours after CC-486 administration.|The PK population were those with evaluable CC-486 plasma PK profiles; PK data from those who received CC-486 200 mg QD were combined because following a single CC-486 dose, the half-life elimination is <1 h; CC 486 does not accumulate following multiple administrations. CC-486 200 mg Days 1-7 and CC-486 200 mg Days 1-14 arms can be combined.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2632370|NCT01835587|Secondary|Kaplan Meier Estimate of Time to Discontinuation From Treatment|The time to discontinuation from treatment was assessed as an estimate of treatment tolerability and was defined as the interval from the date of the first IP dose to the date of discontinuation from IP as indicated on the discontinuation from treatment Case Report Form page. Time to discontinuation from study treatment was analyzed using the Kaplan-Meier method where participants who did not discontinue were censored at the date of last visit.|From the first dose of IP dose to the date of discontinuation from IP; the overall median time to discontinuation of IP was 283.5 days|The safety population includes all participants who received at least one dose of investigational product. Participants who were on treatment at the time of study closure were censored at the date of last available visit|||Days||Inter-Quartile Range|Median
2632371|NCT01835587|Secondary|Percentage of Participants With Graft Versus Host Disease During the Entire Course of the Study|Acute graft versus host disease generally occurs after allogeneic hematopoietic stem cell transplantation. It is a reaction of donor immune cells against host tissues. The 3 main tissues that acute GVHD affects are the skin, liver, and gastrointestinal tract. Chronic GVHD is scored per the National Institute of Health consensus conference grading system. Clinical manifestations of chronic GVHD include skin involvement resembling lichen planus or the cutaneous manifestations of scleroderma; dry oral mucosa with ulcerations and sclerosis of the gastrointestinal tract; and a rising serum bilirubin concentration.|From the first dose of CC-486 up to study discontinuation or death. Up to final data cut off date of 14 July 2017; up to 186 weeks and 4 days|Safety population includes all participants who received at least 1 dose of IP.|||percentage of participants||95% Confidence Interval|Number
2632380|NCT01835548|Secondary|Onset of Effect|Onset of effect was defined as the first time point at which NT0102 separates from placebo on SKAMP-Combined scores. A separation was defined as a statistically significant difference at the 5% level of active drug over placebo. Data was collected separately for NT0102 and Placebo arms and is reported as a comparison analysis of the two arms. This assessment was collected on the full classroom day, Visit 8.|Visit 8 (Day 42) at 1 hour (h), 3 h, 5 h, 7 h, 10 h, 12 h and 13 h|FAS consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized.|||hour|||Number
2632476|NCT01834404|Secondary|Peak Postprandial Level of Total Peptide Tyrosine-Tyrosine (PYY)|Plasma gastrointestinal hormone PYY was measured by radioimmunoassay.|Day 14, approximately 45 minutes after liquid meal||||pg/mL||Standard Error|Mean
2653319|NCT01644240|Primary|AUC0-24|Area under the plasma concentration time curve through 24 hours after dosing.|Day 1||||pg*hr/mL||Standard Deviation|Mean
2632372|NCT01835587|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|A TEAE was defined as any AE with an onset date on or after the first dose of IP or any event already present that worsened in severity or increased in frequency after exposure to IP up to 28 days after the last dose. In addition, an AE that occurred beyond the timeframe and was assessed by the doctor as possibly related to IP was considered to be treatment-emergent. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for AEs (NCI CTCAE) version 4.0, where 1= Mild; 2= Moderate; 3= Severe; 4= Life-threatening; 5= Death related to AE. Serious AEs resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in a medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes above.|From the first dose of investigational product (IP) up to 28 days after the last dose of IP. The median duration of exposure was 252.5 days overall; up to the final data cut off date of 14 July 2017|The safety population includes all participants who received at least one dose of IP.|||participants|||Number
2632373|NCT01835587|Primary|The Number of Participants With Dose Limiting Toxicities (DLT)|"A DLT included events that started within 28 days of the first dose of CC-486 in a 28-day cycle, constituted a change from baseline irrespective of outcome, as decided by the investigator to be related to CC-486 including:~≥ Grade (GR) 3 nausea, diarrhea, or vomiting despite the use of medical support~Other significant nonhematologic toxicity of ≥ GR 3 considered not related to the disease or intercurrent illness • Absolute neutrophil count (ANC) < 0.5 x 10^9/L for > 1 week despite growth factor support~Platelets < 25 x 10^9/L for > 1 week despite transfusion support~Failure of recovery to an ANC ≥ 1.0 x 10^9/L and/or platelets ≥ 50 x 10^9/L with a hypocellular marrow by 56 days after the start of a cycle of CC-486 not due to relapse or progressive disease.~The maximum tolerated dose is defined as the cohort delivering the highest dose in which no more than 33% of the evaluable subjects had a DLT The safety population included subjects who received ≥ 1 dose of CC-486"|2 months (Cycles 1 and 2)|The safety population included all participants who received at least one dose of investigational product.|||participants|||Number
2632374|NCT01835548|Secondary|Number of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Visit 9 (Day 43)|The safety population included all participants who took at least 1 dose of study drug.|||Participants|||Count of Participants
2632375|NCT01835548|Secondary|The Average of the Permanent Product Measure of Performance - Correct (PERMP-C) Score|"The PERMP consisted of 400 math problems and was graded as number of problems Attempted (PERMP-A) and number of problems Correct. (PERMP-C). It was an objective measure of performance during the classroom testing day."|Visit 8 (Day 42)|FAS consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized.|||number of problems correct||Standard Deviation|Mean
2632376|NCT01835548|Secondary|The Average of the Permanent Product Measure of Performance - Attempted (PERMP-A) Score|"The PERMP consisted of 400 math problems and was graded as number of problems Attempted (PERMP-A) and number of problems Correct. (PERMP-C). It was an objective measure of performance during the classroom testing day."|Visit 8 (Day 42)|FAS consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized.|||number of problems attempted||Standard Deviation|Mean
2632377|NCT01835548|Secondary|The Average of the SKAMP-Deportment Scores|"The SKAMP Rating Scale is comprised of 2 behavioural subscales, including the Deportment subscale (4 items). The SKAMP-Deportment subscore evaluates behaviour in the classroom and is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 24. A lower score indicates less symptomatology (i.e. is better). The SKAMP-Attention subscores were derived from 20 minutes of direct observations of participant behaviour. Ratings were based on the frequency and quality of behaviours."|Visit 8 (Day 42)|The Per-Protocol Set were a subset of the FAS consisting of those participants who satisfied all of the inclusion/exclusion criteria and who correctly received the treatment to which they were randomized.|||score on a scale||Standard Deviation|Mean
2632378|NCT01835548|Secondary|The Average of the SKAMP-Attention Scores|"The SKAMP Rating Scale was comprised of 2 behavioral subscales, including the Attention subscale (4 items). The SKAMP-Attention subscore evaluates concentration in the classroom and is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 24. A lower score indicates less symptomatology (i.e. is better). The SKAMP-Attention subscores were derived from 20 minutes of direct observations of participant behavior. Ratings were based on the frequency and quality of behaviors."|Visit 8 (Day 42)|The per-protocol set were a subset of the FAS consisting of those participants who satisfied all of the inclusion/exclusion criteria and who correctly received the treatment to which they were randomized.|||score on a scale||Standard Deviation|Mean
2632379|NCT01835548|Secondary|Duration of Effect|Duration of effect was defined as the last time point at which NT0102 separates from placebo on SKAMP-Combined scores. A separation was defined as a statistically significant difference at the 5% level of active drug over placebo. Data was collected separately for NT0102 and Placebo arms, and is reported as a comparison analysis of the two arms. This assessment was collected on the full classroom day, Visit 8.|Visit 8 (Day 42) at 1 hour (h), 3 h, 5 h, 7 h, 10 h, 12 h and 13 h|FAS consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized.|||hour|||Number
2632405|NCT01835158|Secondary|Objective Response Rates|Objective response rates (ORR) was investigator assessed. ORR is the rate of complete or partial responses, based on RECIST 1.1 criteria. A response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. The Fisher exact test will be used to compare the two treatment arms.|Up to 5 years|All enrolled patients.|||proportion of participants||95% Confidence Interval|Number
2632381|NCT01835548|Primary|Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Score|The primary efficacy endpoint was derived from the SKAMP-Combined score calculated as the total score of all 13 items of the SKAMP-Combined score. The SKAMP-Combined score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible score of 0 to 78. A lower score indicates less symptomatology (i.e., is better). The SKAMP was a rating scale that specifically measures the classroom manifestations of ADHD. The SKAMP ratings were completed for all subjects at baseline (pre-dose) and at 1, 3, 5, 7, 10, 12, and 13 hours post-dose on the classroom testing day (Visit 8). The primary analysis time point for the primary efficacy endpoint was the average of all post-dose SKAMP scores during the 13-hour period.|Visit 8 (Day 42)|The full analysis set (FAS) consisted of all participants randomized to treatment who had at least 1 post-dose SKAMP-Combined treatment assessment during the classroom testing session on Visit 8. Participants were analyzed as randomized.|||score on a scale||Standard Deviation|Mean
2632382|NCT01835496|Primary|T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide|T1/2 (apparent terminal elimination half-life) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.|10-hour interval||||hr||Standard Deviation|Mean
2632383|NCT01835496|Primary|AUC0-∞ for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUC0-∞ (area under the curve, zero to infinity) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.|10-hour interval||||µg*hr/mL||Standard Deviation|Mean
2632384|NCT01835496|Primary|Tmax for Deferiprone and Deferiprone 3-O-glucuronide|"Tmax (time to the maximum measured serum concentration) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.~The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation)."|10-hour interval||||hr||Full Range|Median
2632385|NCT01835496|Secondary|Frequency of Serious Adverse Events||From Day 1 (Dosing) to Day 30 post-dose||||participants|||Number
2632386|NCT01835496|Secondary|Frequency of Adverse Events||From Day 1 (Dosing) to Day 7 plus/minus 3 days (Follow-up)||||participants|||Number
2632387|NCT01835496|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax (maximum measured serum concentration) was assessed over a 10-hour interval for deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained pre-dose and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8, and 10 hours post-dose.|10-hour interval||||μg/mL||Standard Deviation|Mean
2632388|NCT01835470|Secondary|Number of Participants With Positive Immunogenicity During the Short Term Period|A positive immunogenicity response for 'Cytotoxic T-lymphocyte antigen (CTLA4), Immunoglobulin (Ig)', 'Ig and/or Junction Region', respectively = (1) missing baseline immunogenicity measurement and positive analytical laboratory reported immunogenicity response post-baseline (2) negative baseline immunogenicity response and positive analytical laboratory reported immunogenicity response post-baseline (3) positive baseline immunogenicity response and positive analytical laboratory reported immunogenicity response post-baseline with titer value strictly greater than the baseline titer value. Assessment based on assay cutpoint value. Serum samples were collected prior to study medication at Week 0 (Day 1), Week 8 (Day 57), and Week 16 (Day 113) in the short term period. Participants who early discontinued from the study or complete and did not switch to commercial abatacept had a serum sample collected on final visit or early termination visit, 28, 84 and 168 days after the last dose.|Day 1 up to Week 16 (Day 113)|Immunogenicity analysis population: All participants who received at least one dose of study medication and who had at least one immunogenicity result reported after start of study medication|||participants|||Number
2632389|NCT01835470|Secondary|Trough Observed Concentration (Ctrough) of Abatacept During the Short Term Period|Blood samples were collected at 0 hour (pre-dose) on Days 15 and 29 and at 0 hour (pre-dose) and 0.5 hours (post dose) on Days 57, 85, and 113. A blood sample was also collected on an interim visit that occurred on any day between Day 92 and Day 110. ug/mL=micrograms/milliliter|9 time points up to Week 16 (Day 113)|Pharmacokinetic (PK) Analysis Population: All participants who received at least one dose of study medication and who had at least one adequate PK result reported after start of study medication. The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2632390|NCT01835470|Secondary|Maximum Observed Concentration (Cmax) of Abatacept During the Short Term Period|Cmax was obtained from the serum concentration versus time data after intravenous administration of abatacept. Blood samples were collected at 0 hour (pre-dose) on Days 15 and 29 and at 0 hour (pre-dose) and 0.5 hours (post dose) on Days 57, 85, and 113. A blood sample was also collected on an interim visit that occurred on any day between Day 92 and Day 110. ug/mL=micrograms/milliliter|9 time points up to Week 16 (Day 113)|Pharmacokinetic (PK) Analysis Population: All participants who received at least one dose of study medication and who had at least one adequate PK result reported after start of study medication. The 'n' signifies those participants who received study drug and were evaluated for this measure (each group respectively).|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2632391|NCT01835470|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Drug-Related SAEs, Discontinuation Due to Drug-Related SAEs, Drug-Related Adverse Events (AEs), and Discontinuation Due to Drug-Related AEs During the Short Term Period|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. SAEs also include hospitalizations for elective surgical procedures. Drug-related=related or missing relationship to study drug. Data includes all events from the date of the first dose of the study drug up to 56 days post the last dose of the study drug in the short-term period or start of the long-term period, whichever occurred first.|Day 1 up to 56 days post Week 16 (Day 113); approximately 6 months|All Treated Participants: All participants who received at least one dose of study medication|||participants|||Number
2633547|NCT01823510|Primary|Thrombus Formation|Thrombus formation in Badimon Perfusion Chamber high-shear) (ex vivo model of thrombosis).|up to 7 days||||percentage of baseline size||Standard Error|Mean
2632392|NCT01835470|Secondary|Median Percentage of Improvement From Baseline in Physical Function as Assessed by the Childhood Health Assessment Questionnaire (CHAQ) Disability Index at Week 16|Physical function was evaluated using the disability section of the Childhood Health Assessment Questionnaire (CHAQ). The questionnaire was derived from the adult HAQ. The disability section assessed physical functions in 8 domains: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities. The questions were evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty and 3 =unable to do. Higher scores indicate greater dysfunction. A disability index was calculated as the mean of the 8 functional scales. The percentage of Improvement from baseline was calculated using the following equation: (Baseline value - Post-baseline value) / Baseline value x 100.|Week 16 (Day 113)|All Treated Participants: All participants who received at least one dose of study medication|||percentage of improvement from baseline||Inter-Quartile Range|Median
2632393|NCT01835470|Secondary|Percentage of Participants Experiencing a American College of Rheumatology Pediatric 50, 70, 90 Response or Inactive Disease at Week 16|ACR PED 50 response is defined as '≥50% improvement' and '≥3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. ACR PED 70 response is defined as '≥70% improvement' and '≥3 of the 6 JIA core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. ACR PED 90 response is defined as '≥90% improvement' and '≥3 of the 6 JIA core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. Inactive disease status is defined as no active joints, physician's global assessment of disease severity equal or less than 10mm and C-reactive protein (CRP) within normal limits (0.3 mg/dL). A non-responder imputation is applied. mm=millimeter; mg/dL=milligrams/deciliter|Week 16 (Day 113)|All Treated Participants: All participants who received at least one dose of study medication|||percentage of participants||95% Confidence Interval|Number
2632394|NCT01835470|Primary|Percentage of Participants Experiencing a American College of Rheumatology (ACR) Pediatric 30 Response at Week 16|American College of Rheumatology (ACR) pediatric (PED) 30 response was defined as '≥30% improvement' and '≥3 of the 6 Juvenile Idiopathic Arthritis (JIA) core set' and ≥30% worsening in not more than 1 of the 6 JIA core set variables. JIA core set variables defined as the number of active joints, number of joints with Limit of Motion (LOM), physician's global assessment of disease severity, patient global assessment of overall well being, parent assessment of physical function, and acute phase reactant value. A non-responder imputation was applied.|Week 16 (Day 113)|All Treated Participants: All participants who received at least one dose of study medication|||percentage of participants||95% Confidence Interval|Number
2632395|NCT01835431|Secondary|Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill With Ketosis (Blood Ketones Above 1.5 mmol/L)|The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill. The ketone meaurement involved an additional finger prick and ketosis was considered present if blood ketones were higher than 1.5mmol/L|After 16 weeks of treatment|The SAS included all subjects receiving at least one dose of the trial product or its comparator|||episodes|||Number
2632396|NCT01835431|Secondary|Number of Hyperglycaemic Episodes (PG Above 14.0 mmol/L (250 mg/dL) Where Subject Looks/Feels Ill|The episode of hyperglycaemia was noted when the glucose measurement was 14.0mmol/L or above and the subject looked /felt ill.|After 16 weeks of treatment|The SAS included all subjects receiving at least one dose of the trial product or its comparator|||episodes|||Number
2632397|NCT01835431|Secondary|Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes|The confirmed hypoglycaemic episodes occurring between 23:00 and 07:00 were considered for this endpoint|After 16 weeks of treatment|The SAS included all subjects receiving at least one dose of the trial product or its comparator|||episodes|||Number
2632398|NCT01835431|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes (Plasma Glucose (PG) Below 3.1mmol/L (56mg/dL) or Severe Hypoglycaemia)|"Treatment emergent hypoglycaemic episodes (PG < 3.1 mmol/L (56 mg/dL) or severe hypoglycaemia).~Confirmed hypoglycaemic episodes were defined as episodes that were either:~Severe (i.e. the child is having altered mental status and cannot assist in their care, is semiconscious or unconscious or in coma with or without convulsions and may require parenteral therapy (glucagon or i.v. glucose), or~An episode biochemically confirmed by PG value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia."|After 16 weeks of treatment|The SAS included all subjects receiving at least one dose of the trial product or its comparator|||episodes|||Number
2632399|NCT01835431|Secondary|Incidence of Treatment Emergent Adverse Events (TEAEs)|A Treatment Emergent Adverse Event (TEAE) was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day on randomised treatment.|After 16 weeks of treatment|The Safety analysis set (SAS) included all subjects receiving at least one dose of the trial product or its comparator|||number of events|||Number
2632400|NCT01835431|Secondary|Change From Baseline in Fasting Plasma Glucose|Change from baseline in FPG after 16 weeks of treatment. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment.|week 0, week 16|The FAS included all randomised subjects. 338 subjects had assessment at baseline, 326 had assessment at week 16, 2 subjects were withdrawn before exposure and 22 subjects week 16 assessment was not done.|||mmol/L||Standard Deviation|Mean
2632401|NCT01835431|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)|Percentage point change in glycosylated haemoglobin A1c (HbA1c) from baseline (week 0) to 16 Weeks. Change from baseline summary statistics at week 16 contains only those who had both baseline and week 16 assesment.|Week 0 to week 16|The FAS included all randomised subjects. 20 subjects were withdrawn and only 4 subjects though completed the study did not have assesments.|||percentage (%)||Standard Deviation|Mean
2632402|NCT01835379|Secondary|Time to Wound Closure|Kaplan-Meier (K-M) analysis was employed to estimate the median time in weeks to complete ulcer closure.|During the 12 Week treatment period||||weeks||95% Confidence Interval|Median
2632403|NCT01835379|Primary|Percentage of Wounds Closed||At the end of 12 Weeks||||percentage of wounds closed|||Number
2632404|NCT01835262|Primary|Numeric Rating Scale of Pain|"We will compare efficacy as a difference between 2 groups in pain score at 30 minutes post-analgesic administration. The primary outcome is the difference between 2 groups in pain score at 30 minutes.~Pain will be measured via Numeric rating scale from 0 to 10 with 0 being no pain, 5 being moderate pain, and 10 being severe pain"|30 minutes||||Units on a scale||Standard Deviation|Mean
2632407|NCT01835158|Primary|Progression Free Survival (PFS)|Progression free survival (PFS) was investigator assessed and is measured from the beginning of treatment until patient progression or death. Progression was determined using RECIST 1.1 criteria, progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on PFS. The Kaplan-Meier product-limit estimator will be used to estimate PFS distributions.Progression Free Survival was assessed per investigator, as this was the protocol-specified endpoint, and both investigator and independent review analyses of the PFS endpoint have been published|Up to 5 years|All patients that were enrolled on to study.|||Months||95% Confidence Interval|Median
2632408|NCT01835145|Other Pre-specified|Pre-treatment Immune Gene Expression in Tissue Defined as T Cell-inflamed, Intermediate and Non-T Cell-inflamed|The proportions of patients within these groups pre-treatment will be presented with 90% exact binomial confidence intervals. These findings will be correlated with overall survival using a Student's T-test.|Baseline|||||||
2632409|NCT01835145|Other Pre-specified|Pre-treatment GNAQ/GNA11 and Potentially Other Mutations in Tissue|The proportions of patients within these groups pre-treatment will be presented with 90% exact binomial confidence intervals. These findings will be correlated with overall survival using a Student's T-test.|Baseline|||||||
2632410|NCT01835145|Secondary|PFS|The distribution of PFS time will be estimated using the method of Kaplan Meier and is defined as the number of days from registration until disease progression (or death). Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, with an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|Number of days from registration until disease progression (or death), assessed up to 2 years||||months||95% Confidence Interval|Median
2632411|NCT01835145|Secondary|Overall Survival (OS)|The distribution of OS time will be estimated using the method of Kaplan Meier.|Number of days from registration until death, assessed up to 2 years||||months||95% Confidence Interval|Median
2632412|NCT01835145|Secondary|Percentage of Patients Who Experienced Grade 3+ Adverse Events Regardless of Attribution|percentage of patients who experienced grade 3+ adverse events regardless of attribution, graded according to the National Cancer Institute CTCAE version 4.0|Up to 2 years||||percentage of patients|||Number
2632413|NCT01835145|Secondary|Confirmed Response Rate as Determined by the RECIST Criteria (Version 1.1)|The confirmed response rates will be estimated by dividing the number of confirmed responders by the number of evaluable patients. 95% confidence intervals will be calculated.|Up to 2 years||||Participants|||Count of Participants
2632414|NCT01835145|Primary|Proportion of Patients Without a Progression Free Survival Event at 4 Months (PFS4)|A patient will be declared a PFS4 success if they are on study and progression free for at least 4 months. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, with an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. The success for each arm will be calculated independently as the number of successes divided by the total number of evaluable patients. A one-sided chi-squared test for a difference in PFS4 proportions will be used to test for a difference between arms.|At 4 months|All patients that began protocol treatment were included in this analysis.|||proportion of participants||95% Confidence Interval|Number
2632415|NCT01835132|Secondary|Changes in Scleral Grading From Baseline to Week 52|Scleral inflammation was summarized on an ordinal scale as either none, minimal/trace, mild, moderate, severe or necrotizing inflammation in the four quadrants of the study eye (superonasal [SN], superotemporal [ST], inferotemporal [IT], and inferonasal [IN]) for each participant at each visit. The exact change from Baseline to Week 52 for each participant (such as from mild to severe) cannot be quantified; therefore, we chose not to report due to the difficulty of reporting a quantitative change in each quadrant for each participant within the limited parameters allowed by PRS.|Baseline and Week 52|The exact change from Baseline to Week 52 for each participant (such as from mild to severe) cannot be quantified; therefore, we chose not to report due to the difficulty of reporting a quantitative change in each quadrant for each participant within the limited parameters allowed by PRS.||||||
2632416|NCT01835132|Secondary|Number of Participants With Loss of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Post-injection through study completion, up to 78 weeks per participant|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||participants|eyes||Number
2632417|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Final Safety Visit Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Final Visit|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||mmHg|eyes|Standard Deviation|Mean
2632418|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 62 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 62|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||mmHg|eyes|Standard Deviation|Mean
2632477|NCT01834404|Secondary|Peak Postprandial Level of Total Glucagon-Like Peptide-1 (GLP-1)|Plasma gastrointestinal hormone GLP-1 was measured by radioimmunoassay.|Day 14, approximately 45 minutes after liquid meal||||pg/mL||Standard Error|Mean
2632419|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 58 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 58|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||mmHg|eyes|Standard Deviation|Mean
2632420|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 54 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 54|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||mmHg|eyes|Standard Deviation|Mean
2632421|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 52A Compared to Baseline|"This visit represents the beginning of the as-needed 2nd Extension Phase at Week 52. If eligible, participants continued with injections at Wks 52, 54, 58 and 62.~Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg)."|Baseline and Week 52A|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||mmHg|eyes|Standard Deviation|Mean
2632422|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 52 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 52|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
2632423|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 40 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 40|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
2632424|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 36 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 36|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
2632425|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 32 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 32|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
2632426|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 28 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 28|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
2632427|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 24 Compared to Baseline|Mean Change in Intraocular pressure (IOP) is measured and reported as change in IOP between baseline and 24 weeks in millimeters of mercury (mmHg).|Baseline and Week 24|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
2632428|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 20 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 20|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
2632429|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 16 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 16|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
2632430|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 12 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 12|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
2635091|NCT01807624|Primary|AUC0-t of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||ng*h/mL||Standard Deviation|Mean
2632431|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 8 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 8|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
2632432|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 4 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 4|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
2632433|NCT01835132|Secondary|Mean Change in Intraocular Pressure in the Study Eye (or Eyes) at Week 2 Compared to Baseline|Intraocular pressure (IOP) is measured in millimeters of mercury (mmHg).|Baseline and Week 2|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||mmHg|eyes|Standard Deviation|Mean
2632434|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Final Safety Visit Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Final Visit|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||ETDRS letters|eyes|Standard Deviation|Mean
2632435|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 62 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 62|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||ETDRS letters|eyes|Standard Deviation|Mean
2632436|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 58 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 58|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||ETDRS letters|eyes|Standard Deviation|Mean
2632437|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 54 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 54|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||ETDRS letters|eyes|Standard Deviation|Mean
2632438|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 52A Compared to Baseline|"This visit represents the beginning of the as-needed 2nd Extension Phase at Week 52. If eligible, participants continued with injections at Wks 52, 54, 58 and 62.~Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20."|Baseline and Week 52A|Eight participants were active from Baseline to Week 28. Of the 8 active participants, one participant had two study eyes and was active to Week 28. Two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52. Three participants were active from Week 52 to study end.|||ETDRS letters|eyes|Standard Deviation|Mean
2632439|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 52 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 52|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
2632478|NCT01834404|Secondary|Peak Postprandial Level of Cholecystokinin (CCK)|Plasma gastrointestinal hormone CCK was measured by radioimmunoassay based on an antibody with very low cross-reactivity to gastrin 17 and its sulfated counterpart, and to sensitivity to a concentration of 0.3 pmol/L.|Day 14, approximately 45 minutes after liquid meal||||pg/mL||Standard Error|Mean
2632479|NCT01834404|Secondary|Fasting Ghrelin|Plasma gastrointestinal hormone total ghrelin was measured by radioimmunoassay.|Day 14, before liquid meal||||pg/mL||Standard Error|Mean
2632440|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 40 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 40|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
2632441|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 36 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 36|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
2632442|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 32 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 32|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
2632443|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 28 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 28|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
2632444|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 24 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 24|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
2632445|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 20 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 20|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
2632446|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 16 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 16|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
2632447|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 12 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 12|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
2632448|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 8 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 8|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
2667678|NCT01513122|Secondary|Mean Total Body Fat Changes From Baseline to 48 Weeks as Measured by DXA Scan||48 weeks||||kg||95% Confidence Interval|Mean
2632449|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 4 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 4|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
2632450|NCT01835132|Secondary|Mean Change in Visual Acuity in the Study Eye (or Eyes) at Week 2 Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 2|Eight participants were active from Baseline to Week 28. Of the eight active participants, one participant had two study eyes, and this participant was active in the study to Week 28. A total of two participants did not continue past Week 28 due to insufficient therapeutic response. Six participants were active from Week 32 to Week 52.|||ETDRS letters|eyes|Standard Deviation|Mean
2632451|NCT01835132|Primary|Number of Participants With at Least a 2-step Reduction or Reduction to Grade 0 in Scleral Inflammation in the Study Eye (or Eyes), According to the National Eye Institute (NEI) Photographic Scleritis Grading System, on or Before the Week 16 Visit.|Scleral inflammation was graded following 10% Phenylephrine application with an ordinal scale of 0 (no scleral inflammation with complete blanching of vessels), 0.5+ (minimal/trace inflammation with localized pink appearance of the sclera around minimally dilated deep episcleral vessels), 1+ (mild inflammation with diffuse pink appearance of the sclera around mildly dilated deep episcleral vessels), 2+ (moderate inflammation with purplish pink appearance of the sclera with tortuous and engorged deep episcleral vessels), 3+ (severe inflammation with diffuse significant redness of sclera, the details of superficial and deep episcleral vessels can't be observed), and 4+ (necrotizing inflammation with diffuse redness of the sclera with scleral thinning and uveal show).|Baseline and Week 16||||participants|||Number
2632452|NCT01835015|Secondary|Apparent Systemic (or Total Body) Clearance From Serum Following Extravascular Administration (CL/F)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.||||||
2632453|NCT01835015|Secondary|The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.||||||
2632454|NCT01835015|Secondary|Terminal Elimination Half-life (T½)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.||||||
2632455|NCT01835015|Secondary|"Area Under the Serum Concentration-time Curve From Time Zero to Time t Where t is a Defined Time Point After Administration [AUC(0-t)]"|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561.||||||
2632456|NCT01835015|Secondary|Dose-normalized Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)/D]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.|||hr*ng/mL/mg||Standard Deviation|Mean
2632457|NCT01835015|Secondary|Dose Normalized Observed Maximum Serum Concentration Following Drug Administration (Cmax/D)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.|||ng/mL/mg||Standard Deviation|Mean
2632458|NCT01835015|Secondary|Time to Reach the Maximum Serum Concentration After Drug Administration (Tmax)|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.|||hours||Standard Deviation|Mean
2632473|NCT01834651|Primary|Clinical Benefit Rate From Cabozantinib (XL184)|"Clinical benefit rate is defined as the combination of complete response, partial response, and stable disease as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by CT imaging and Prostate Cancer Working Group 2 (PCWG2) criteria.~Complete response (CR) defined as disappearance of all target lesions; Partial response (PR) >=30% decrease in som of diameters of target lesions (taking as reference the baseline), and stable disease, neither sufficient shrinkage to qualify for PR nor increase to qualify for progressive disease."|Baseline to 12 weeks after starting therapy||||Participants|||Count of Participants
2632459|NCT01835015|Secondary|Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.|||hr*ng/mL||Standard Deviation|Mean
2632460|NCT01835015|Secondary|Area Under the Serum Concentration-time Curve (AUC) From Time Zero to All [AUC(0-all)]|Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.|Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85|This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred.|||hr*ng/mL||Standard Deviation|Mean
2632461|NCT01835015|Primary|Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment|A slit-lamp biomicroscopy examination was performed to evaluate the anterior segment of the eye. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication.|Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85|This analysis population includes all enrolled subjects who received investigational product.|||participants|||Number
2632462|NCT01835015|Primary|Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment|A dilated fundus examination was performed to evaluate the health of the retina, macula, choroid, and optic nerve. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication.|Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85|This analysis population includes all enrolled subjects who received investigational product.|||participants|||Number
2632463|NCT01835015|Primary|Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye|IOP was measured by Goldmann applanation tonometry or tonopen, at the discretion of the Investigator, and reported in mmHg (millimeters of mercury). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis.|Baseline, Day 1, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85|"This analysis population includes all enrolled subjects who received investigational product. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||mmHg||Standard Deviation|Mean
2632464|NCT01835015|Primary|Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye|BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85|"This analysis population includes all enrolled subjects who received investigational product. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||letters||Standard Deviation|Mean
2632465|NCT01834729|Primary|Weekly Rate of Complete Spontaneous Bowel Movements at 4 Weeks|If the subject indicates that the spontaneous bowel movement (SBM) was associated with a sensation of complete bowel emptying, the SBM will be counted as a complete spontaneous bowel movement (CSBM).|4 weeks||||complete SBM per week||Standard Error|Mean
2632466|NCT01834729|Primary|Weekly Rate of Spontaneous Bowel Movements at 4 Weeks|A bowel movement is considered a spontaneous bowel movement (SBM) if no laxative, enema, or suppository was taken in the preceding 24 hours.|4 weeks||||spontaneous bowel movements per week||Standard Error|Mean
2632467|NCT01834716|Primary|Number of Subjects Retained at 6 Months|The number of subjects retained at 6 month end of study time point.|6 months||||Participants|||Count of Participants
2632468|NCT01834651|Secondary|Number of Patients With Evaluable Protein Content of Large Oncosomes From Baseline to First Documented Progression or Date of Death|This is a feasibility outcome to assess ability to measure protein content in large oncosomes in this population.|From baseline until the date of first documented progression or date of death from any cause, whichever comes first, assessed for an expected average of 28 weeks.|Only 12 samples were analyzed.|||Participants|||Count of Participants
2632469|NCT01834651|Secondary|Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4)|Each cycle is 28 days. Safety and tolerability was defined as related grade 3-4 AEs of doses of cabozantinib below 100 mg daily using common terminology criteria for adverse events (CTCAE)|Every 2 weeks for first 3 Cycles and every 4 weeks thereafter for an expected average of 28 weeks.|All patients|||Participants|||Count of Participants
2632470|NCT01834651|Secondary|Change in Levels of Serum Hepatocyte Growth Factor (HGF) and Vascular Endothelial Growth Factor (VEGF) Concentration|Mean change from baseline in levels of HGF and VEGF|12 weeks|HGF was evaluable in 16 patients who had viable research samples. VEGF was evaluable in 15 patients who had viable research samples.|||pg/ml||Standard Deviation|Mean
2632471|NCT01834651|Secondary|Number of Patients With NanoVelcro Appropriate for RNA in Circulating Tumor Cells|This is to provide a measure of feasibility using NanoVelcro to measure RNA in circulating tumor cells (CTC)|12 weeks|There were 16 patients evaluable for this outcome (1 patient did not have RECIST measurable disease)|||Participants|||Count of Participants
2632472|NCT01834651|Secondary|Change in Number of Circulating Tumor Cells (CTC) in Response to Cabozantinib|Change in number of CTC from baseline at 12 weeks|Baseline and 12 weeks||||CTCs/7.5 ml||Standard Deviation|Mean
2638880|NCT01769443|Secondary|Incidence of Death||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
2632480|NCT01834404|Secondary|Change in Postprandial Gastric Volume|Change between postprandial and fasting whole gastric volume by 99mTc-SPECT Imaging. A noninvasive SPECT method was used to measure gastric volume during fasting and 32 min after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication was given s.c. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans were obtained. Each scan required 9-12 min. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content.|Day 13, approximately approximately 30 min after liquid meal||||mL||Standard Error|Least Squares Mean
2632481|NCT01834404|Secondary|Solid Gastric Emptying: Proportion Remaining at 4 Hours|At visit 6 subjects took part in a gastric emptying by scintigraphy test. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contained a small amount of radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal remaining at 4 hours.|Day 15, approximately 4 hours after radiolabeled meal was ingested||||proportion of meal remaining||Standard Error|Least Squares Mean
2632482|NCT01834404|Primary|Buffet Meal Intake|"At visit 4 subjects underwent imaging to measure the volume of their stomach, fasting and after ingesting a liquid nutrient drink. Four hours after the liquid meal, subjects were invited to eat, over a 30-minute period, a standard all you can eat meal vegetable lasagna, vanilla pudding, and skim milk. The total Kcal of the food consumed was analyzed by using validated software."|Day 13, approximately 4.5 hours after liquid meal||||Kcal||Standard Error|Mean
2632483|NCT01834404|Primary|Maximum Tolerated Volume|At visit 5, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure is the volume consumed when the fullness sensation reached level 5.|Day 14, approximately 30 minutes after liquid meal||||mL||Standard Error|Mean
2632484|NCT01834404|Primary|Volume to Fullness|At visit 5, subjects did a satiation/nutrient drink test. Participants recorded their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure was the volume consumed when the fullness sensation reached level 3.|Day 14, approximately 30 minutes after liquid meal||||mL||Standard Error|Mean
2632485|NCT01834404|Primary|Postprandial Gastric Volume|Postprandial gastric volume was measured by 99mTc-SPECT Imaging. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. After the liquid meal tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content.|Day 13, approximately 30 minutes after liquid meal||||mL||Standard Error|Mean
2632486|NCT01834404|Primary|Fasting Gastric Volume|Fasting whole gastric volume was measured by Technetium (99mTc)-SPECT Imaging. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content.|Day 13, approximately 10 minutes after Technetium (99mTC) injection||||mL||Standard Error|Mean
2632487|NCT01834404|Secondary|Solid Gastric Emptying: Proportion of Meal Emptied at 2 Hours|At visit 6 subjects took part in a gastric emptying by scintigraphy test. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contained a small amount of radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 2 hours.|Day 15, approximately 2 hours after radiolabeled meal was ingested||||proportion of meal emptied||Standard Error|Least Squares Mean
2632488|NCT01834404|Primary|Gastric Emptying of Solids Half-Time (T 1/2)|Gastric emptying of solids half-time is defined as the time for half of the ingested solids to leave the stomach. At visit 6 subjects took part in a gastric emptying by scintigraphy test. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contained a small amount of radioactive substance. At the completion of the meal, subjects stood in front of a special camera and pictures were taken at specific intervals.|Day 15, approximately 2 hours after radiolabeled meal was ingested||||minutes||Standard Error|Mean
2632489|NCT01834274|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|The change between FPG collected at week 24 or final visit relative to Baseline. A negative change from Baseline indicated improvement.|Baseline and Week 24|All randomized participants with data available for analysis.|||mmol/L||Standard Deviation|Mean
2632490|NCT01834274|Secondary|Percentage of Participants With HbA1c <7% at Week 24|The percentage of participants with glycosylated hemoglobin less than 7% after 24 weeks of treatment.|Week 24|As pre-defined in the SAP, no summary is provided for the secondary efficacy endpoint incidence of HbA1c <7% at Week 24 due to the limited enrollment and study duration at the time of study termination.||||||
2632491|NCT01834274|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 or final visit relative to Baseline. A negative change from Baseline indicated improvement.|Baseline and Week 24|All randomized participants with data available for analysis.|||Percent||Standard Deviation|Mean
2632522|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure)||1 week|"This outcome was not analyzed as we feel that the outcome percentage of time <50mg/dl is a n equivalent indicator of severe hypoglycemia instead of area over the curve, and can be used to compare outcomes with other studies."||||||
2667679|NCT01513122|Primary|Mean Limbs Fat Changes From Baseline to 48 Weeks as Measured by DXA Scan||48 weeks||||percentage change||95% Confidence Interval|Mean
2632492|NCT01834261|Secondary|Functional Connectivity Between OFC and AMY|"During functional scans, subjects participated in an interactive neuroeconomic game, an iterative version of the classical Trust Study. Subjects participated in an interactive neuroeconomic game, an iterative version of the classical Trust Study. During this game, the subject ('investor') is first provided a sum of money (20 units). He then has the choice in terms of how much to invest in a fictional computer-generated trustee. The trustee then sends some percentage back to the subject ('investor'), and the game iterates over 20 trials (rounds).~Using Dynamical Causal Modeling (DCM) we modeled the dynamic interaction between amygdala (AMY), nucleus accumbens (NAcc) and the orbitofrontal cortex (OFC). We observed altered connectivity strength between AMY and OFC under OT as compared to PL conditions."|Within two weeks of enrollment completion.|Healthy adult men (17 subjects completed the task fMRI (Trust Study) at MGH, remaining 3 subjects at MGH did not complete the task). The values reported for connections strengths below (0.45 and 0.18) are from the Bayesian Parameter Averaging. The measure of precision is the associated posterior probability, which is 1 for both.|||Hz||Standard Deviation|Mean
2632493|NCT01834261|Primary|Number of Malevolent Rounds|"This study recruited healthy adults. Subjects participated in an interactive neuroeconomic game, an iterative version of the classical Trust Study. During this game, the subject ('investor') is first provided a sum of money (20 units). He then has the choice in terms of how much to invest in a fictional computer-generated trustee. The trustee then sends some percentage back to the subject ('investor'), and the game iterates over 20 trials (rounds). We computed the investment ratio as the ratio of the actual investment and the maximum allowed amount of 20 units, and analogously for the repayment ratio. Malevolent rounds were defined as those with decreased investment ratios even after an increased repayment ratio."|Immediately after completion of the study, for each subject.|Healthy adult men.|||number of rounds||Standard Deviation|Mean
2632494|NCT01834261|Primary|Number of Benevolent Rounds|"This study recruited healthy adults. Subjects participated in an interactive neuroeconomic game, an iterative version of the classical Trust Study. During this game, the subject ('investor') is first provided a sum of money (20 units). He then has the choice in terms of how much to invest in a fictional computer-generated trustee. The trustee then sends some percentage back to the subject ('investor'), and the game iterates over 20 trials (rounds). We computed the investment ratio as the ratio of the actual investment and the maximum allowed amount of 20 units, and analogously for the repayment ratio. Benevolent rounds were defined as those with increased investment ratios even after a decreased repayment ratio."|Immediately after completion of the study, for each subject.|Healthy adult men.|||number of rounds||Standard Deviation|Mean
2632495|NCT01834222|Primary|Percentage of Adverse Events (AEs) With Their Causal Relationship to Study Drug|Criteria: a)Certain: followed a reasonable time sequence from administration of drug; unexplained by other drugs, chemical substance or accompanying diseases;had clinically reasonable reaction on cessation of drug; had pharmacological or phenomenological reaction to re-administration of drug, b)Probable: followed a reasonable time sequence from administration of the drug; unexplained by other drugs;chemical substance or accompanying diseases; had clinically reasonable reaction on cessation of the drug, c)Possible:followed a reasonable time sequence from administration of drug; can also be explained by other drugs;chemical substance or accompanying diseases; lacks information or had unclear information on discontinuation of drug, d)Unlikely:not likely to had a reasonable causal relationship from administration of drug; seemed temporary; can also be reasonably explained by other drugs; chemical substances or latent diseases; conditional (need more data for true assessment),unaccessible.|Baseline (Day 1) up to Day 29|"Safety analysis set included all participants who received at least 1 dose of Prevenar 13. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of adverse events|||Number
2632496|NCT01834222|Primary|Number of Participants Who Discontinued Due to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline (Day 1) up to Day 29|"Safety analysis set included all participants who received at least 1 dose of Prevenar 13. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||participants|||Number
2632497|NCT01834222|Primary|Number of Participants With Outcome in Response to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was assessed among participants based on their response to a question 'Is the adverse event still present?' as 'yes', 'unknown' or 'no (resolved)' during study.|Baseline (Day 1) up to Day 29|"Safety analysis set included all participants who received at least 1 dose of Prevenar 13. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||participants|||Number
2632498|NCT01834222|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed on basis of severity as follows: a) mild: did not caused any significant problem to the participant; b) moderate: caused problem that did not interfere significantly with usual activities or the clinical status, other therapy needed due to AE; c) severe: caused problem that interfered significantly with usual activities or the clinical status.|Baseline (Day 1) up to Day 29|Safety analysis set included all participants who received at least 1 dose of Prevenar 13.|||participants|||Number
2632499|NCT01834222|Primary|Duration of Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of adverse event (in days) was defined as total time from onset of adverse event till the event was resolved during study.|Baseline (Day 1) up to Day 29|Safety analysis set included all participants who received at least 1 dose of Prevenar 13.|||days||Standard Deviation|Mean
2632523|NCT01833988|Secondary|Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure)||1 week|"This outcome was not analyzed as we feel that the outcome percentage of time <70mg/dl is an equivalent indicator of hypoglycemia exposure instead of area over the curve, and can be used to compare outcomes with other studies."||||||
2632524|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas) and Open-loop (Insulin Pump) in Mean Continuous Glucose Monitoring Glucose (CGMG)|Day 2-5|Day 2-5||||mg/dl||Standard Deviation|Mean
2632525|NCT01833988|Secondary|Difference in Mean CGMG on Day 1 vs. Remaining Days (Days 2-5) Between Closed Loop (Bionic Pancreas Arm) and Usual Care (Insulin Pump Arm)||1 week||||mg/dl||Standard Deviation|Mean
2632500|NCT01834222|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (up to Day 29) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AE.|Baseline (Day 1) up to Day 29|Safety analysis set included all participants who received at least 1 dose of Prevenar 13.|||participants|||Number
2632501|NCT01834144|Secondary|Glycaemic Variability, Measured by the Mean Amplitude of Glycaemic Excursions (MAGE), in the 12-hour Period Following Exercise. This is Calculated From the Same Continuous Glucose Monitor Data as the Primary Outcome.||Measured at baseline, and 1, 8, 16 and 52 weeks following randomization|||||||
2632502|NCT01834144|Primary|Time Spent in Hypoglycaemia in the 12-hour Period Following Exercise, Defined as an Interstitial Glucose Reading <4.0mmol/L and Measured by Continuous Glucose Monitor.||Measured at baseline, and 1, 8,16 and 52 weeks following randomization|||||||
2632503|NCT01834027|Secondary|Mean Blood Pressure|non-invasive mean blood pressure will be measured every 5 minutes for a period of 60 minutes|60 minutes|||||||
2632504|NCT01834027|Secondary|Mean Difference in Patient's Perception of Pain From Baseline|The patient will be asked to rate her level of pain using a numeric rating scale from 0-10 (0 indicates no pain and 10 indicates extreme pain). Baseline will be value upon entering PACU. The difference between the values at specific times and the baseline value will be calculated.|10, 20 , and 30 minutes after baseline measurement||||units on a scale||95% Confidence Interval|Mean
2632505|NCT01834027|Secondary|Difference in Patient's Perception of Anxiety From Baseline Score Upon Arrival in the PACU|Upon arrival in the PACU, patient will be asked to rate her level of anxiety using a numeric rating scale from 0-10 (0 indicates no anxiety while 10 indicates extreme anxiety). After wearing headphones for 30 minutes, with either jazz music or no music, the patient will reassess her anxiety level. The difference between the 30 minute score and the baseline will be calculated.|Once, at 30 minutes after the patient entered the PACU|2 participants in the jazz group nad 1 participant in the no music group did not provide an anxiety score.|||units on a scale||Standard Deviation|Mean
2632506|NCT01834027|Primary|Change in Heart Rate From Baseline on Arrival in PACU|Mean difference in heart rate from baseline measurement taken upon the patient's arrival to the PACU. Heart rate will be measured through pulse oximetry|5, 10, 15, 20, 25, 30 minutes after baseline measurement on patient's arrival in PACU||||beats per minute||95% Confidence Interval|Mean
2632507|NCT01833988|Other Pre-specified|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean Insulin Total Daily Dose||1 week||||unit/kg/day||Standard Deviation|Mean
2632508|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia at Night||1 week||||interventions|||Number
2632509|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Carbohydrate Interventions for Hypoglycemia||1 week||||number of interventions|||Number
2632510|NCT01833988|Secondary|Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 50 mg/dl (Measure of Total Hypoglycemia Exposure) at Night||1 week|"This outcome was not analyzed as we feel that the outcome percentage of time <50mg/dl at nightime is an equivalent indicator of severe overnight hypoglycemia exposure instead of area over the curve, and can be used to compare outcomes with other studies."||||||
2632511|NCT01833988|Secondary|Difference Between Closed-loop and Open-loop in Area Over the Curve and Below 70 mg/dl (Measure of Total Hypoglycemia Exposure) at Night||1 week|"This outcome was not analyzed as we feel that the outcome percentage of time <70mg/dl at nightime is an equivalent indicator of overnight hypoglycemia exposure instead of area over the curve, and can be used to compare outcomes with other studies."||||||
2632512|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl) at Night||1 week||||percentage of time||Standard Deviation|Mean
2632513|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG at Night|Day 2-5|Day 2-5||||mg/dl||Standard Deviation|Mean
2632514|NCT01833988|Secondary|Difference Between Closed-loop and Open-loop in Fraction of Time at Night Spent Within Glucose Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)||1 week||||percentage of time||Standard Deviation|Mean
2632515|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Time Spent in Hypoglycemia (Plasma BG <Than 70 mg/dl) at Night||1 week||||percentage of time||Standard Deviation|Mean
2632516|NCT01833988|Secondary|Difference Between Closed-loop and Open-loop in Average BG as Determined From All HemoCue Measurements Taken During the Nighttime Including All Extra Measurements Taken for Hypoglycemia Monitoring.||1 week||||mg/dl||Standard Deviation|Mean
2632517|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values at Night (11:00 PM to 7:00 AM)||1 week||||Standard deviation of mean values|||Number
2632518|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Standard Deviation of CGMG Values (Glycemic Variability) in Different BG Ranges.|"Difference between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in standard deviation of CGMG values (glycemic variability) in different BG ranges.~%<70 70-120 70-180 %>180 %>250"|1 week||||Standard deviation of mean values|||Number
2632519|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean CGMG During Exercise||1 week|Data not obtained for exercise period||||||
2632520|NCT01833988|Secondary|Difference Between Closed-loop and Open-loop in Mean CGMG in the Four Hour Period Following Meals||1 week|Data was not collected to measure this outcome||||||
2632521|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean CGMG < 154 mg/dl||1 week||||Participants|||Count of Participants
2632526|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Severe Hypoglycemic Episodes and Nadir BG During Exercise||1 week|Individual data during exercise was not analyzed. No episodes of severe hypoglycemia were observed on bionic pancreas and only 1 episode of severe hypoglycemia occurred in usual care arm (insulin pump)|||Participants|||Count of Participants
2632527|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Mean BG During Exercise||1 week|Data on exercise not collected||||||
2632528|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Fraction of Time Spent Within CGMG (Continuous Glucose Monitor) Ranges (< 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl)||1 week|Fraction of time < 70 mg/dl, 70-120 mg/dl, 70-180 mg/dl, > 180 mg/dl, > 250 mg/dl|||percentage of time||Standard Deviation|Mean
2632529|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Hypoglycemic Events (BG <70mg/dl) as Determined From HemoCue Measurements||Day 1-5||||events|||Number
2632530|NCT01833988|Secondary|Difference in the Percentage of Study Days With Mean CGM BG </= 154 mg/dl Over the Duration of the Closed-loop Period vs. the Usual Care Period||Day 2-5||||percentage of days||Standard Deviation|Mean
2632531|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Number of Subjects With Mean BG < 154 mg/dl||Day 2-5||||Participants|||Count of Participants
2632532|NCT01833988|Secondary|Difference Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in Average BG as Determined From All HemoCue Measurements Taken During the Day/Nighttime Including All Extra Measurements.|Difference between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) in average BG as determined from all HemoCue measurements taken during the day/nighttime including all extra measurements taken before meals, taken during exercise, and taken for hypoglycemia monitoring.|1 week|This data was not analysed to prevent bias. This information would have been misleading (unscheduled BG checks were performed to confirm a low BG mostly). Overall CGM trend, incidence/duration of hypoglycemia and BG trend during and after exercise is separately analyzed under other secondary outcomes.||||||
2632533|NCT01833988|Primary|Percentage of Time With a Low Plasma Glucose Reading (Less Than 70mg/dl) in the Bionic Pancreas Arm as Compared to Insulin Pump Arm||1 week||||percentage of time||Standard Deviation|Mean
2632534|NCT01833988|Primary|Difference in Average Blood Glucose (BG) Between Closed-loop (Bionic Pancreas Arm) and Open-loop (Insulin Pump Arm) Periods as Determined From All Scheduled HemoCue Measurements With Mean Evenly Weighted Across the Daytime and Nighttime Hours.||1 week||||mg/dL||Standard Deviation|Mean
2632535|NCT01833936|Primary|Reduce Calf Muscle Atrophy|Magnetic resonance imaging (MRI) scans were conducted preoperatively and postoperatively at weeks 2 and 6 to measure cross sectional muscle volumes of the calf muscle. By measuring the muscle volume, the investigators hope to show the use of electrical stimulation will reduce calf muscle atrophy.|Pre-operative, 2 weeks, and 6 weeks post-operative|Pre-operatively, 20 subjects were analyzed per arm. Due to subject withdrawal, 19 were available in Group 1 at 2 weeks; and only 16 were available in Group 1 at 6 weeks, and 10 were available in Group 2 at 6 weeks.|||mm^2||Standard Deviation|Mean
2632536|NCT01833897|Secondary|Beck's Depression Inventory|Range 0-63, with higher scores worse. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|8 weeks||||units on a scale (final score)||Standard Deviation|Mean
2632537|NCT01833897|Secondary|Hamilton Anxiety Scale|Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indi- cates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.|8 weeks||||units on a scale (final score)||Standard Deviation|Mean
2632538|NCT01833897|Secondary|HAM-D Suicide Item|Ham-D suicide item: range 0-4, higher scores indicate worse symptoms|8 weeks||||units on a scale (final)||Standard Deviation|Mean
2632539|NCT01833897|Secondary|Loss of Motivated Behavior HAM-D Factor|includes the total of four HAM-D items: (Item 7: Work and activities, Item 12. Somatic symptoms (appetite), Item 14. Genital symptoms (libido), and Item 16. Weight loss). Range 0-11, higher scores indicate worse symptoms|8 weeks|bipolar depression|||units on a scale (final score)||Standard Deviation|Mean
2632540|NCT01833897|Primary|Hamilton Depression Rating Scale (HAM-D)|"Depression rating scale: Range 0-53, higher scores indicate worse depression. 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥ 23 = Very Severe Depression"|8 weeks|bipolar depression|||units on a scale (final score)||Standard Deviation|Mean
2632541|NCT01833845|Secondary|Efficacy|To evaluate the efficacy of 8 weeks monotherapy with RBV in HCV-infected patients.|8 weeks|||||||
2632542|NCT01833845|Primary|Safety: Number of Participants With Adverse Events|Safety was assessed throughout study by collection of adverse event and concomitant medication data, and routine monitoring of lab safety tests, physical exams, ophthalmic examination, vital signs and 12 lead electrocardiograms.|all 24 weeks||||participants|||Number
2632543|NCT01833845|Primary|Efficacy|To evaluate the effect of 16-week combination therapy with RBV plus HCQ following 8 weeks of monotherapy with RBV in HCV-infected patients.|24 weeks|||||||
2632544|NCT01833832|Secondary|Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 34 months and 28 days.||||Participants|||Count of Participants
2632559|NCT01833741|Secondary|Percentage of Patients Discontinuing Due to Ocular Adverse Events|Ocular adverse events are defined as any untoward medical occurrence in a patient's eye(s) during study participation, regardless of relationship to treatment.|12 Weeks|Intent to Treat: all patients who were consented and completed the Baseline visit|||Percentage of Patients|||Number
2632545|NCT01833832|Secondary|The Functional Assessment of Cancer Therapy-Colorectal Quality of Life (FACT-G) (QOL) Score Prior to Surgery, 6 Weeks After Surgery, and 3 Months After Surgery|QOL characteristics were collected using The Functional Assessment of Cancer Therapy-Colorectal Quality of Life (QOL) questionnaire version 4, a validated survey that interrogates physical, emotional, functional, and social well being in cancer related issues on a 5-point scale. Scores range from 0 to 108 points. Higher scores are consistent with a better outcome.|Prior to surgery, 6 weeks post surgery, and 3 months post surgery|One patient could not be optimally cytoreduced for hyperthermic intraperitoneal chemotherapy (HIPEC) and therefore did not receive intraperitoneal chemotherapy.|||scores on a scale||Full Range|Mean
2632546|NCT01833832|Secondary|Percentage of Participants Who Survived 5-years Post Treatment|Percentage of participants who are alive after treatment.|5 years|Nine patients underwent cytoreduction and HIPEC, including one patient who recurred and was re-treated (n = 10 treatments). One patient could not be optimally cytoreduced for HIPEC and therefore did not receive intraperitoneal chemotherapy.|||percentage of participants||95% Confidence Interval|Number
2632547|NCT01833832|Secondary|Number of Patients With Treatment Related Morbidity Following the Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) Procedure|Patients who died following the HIPEC procedure. The HIPEC is a surgical procedure in which two large bore catheters are inserted in the abdominal wall over the liver and pelvis. The physician closes the abdominal fascia and the catheters are connected to a perfusion circuit. The temperature of the catheters is carefully monitored while the physician ensures the perfusion is distributed properly by manually moving the abdomen.|Patients were assessed every 3 months up to an average of 17 months.|One patient could not be optimally cytoreduced for HIPEC and therefore did not receive intraperitoneal chemotherapy.|||Participants|||Count of Participants
2632548|NCT01833832|Primary|Intraperitoneal Progression Free Survival (PFS)|Amount of time subject survives without intraperitoneal disease progression after treatment. Disease progression is defined as imageable tumor nodules or increasing ascites persistent on computed tomography (CT) scan as interpreted by the official interpretation of the imaging studies.|Amount of time subject survives without intraperitoneal disease progression after treatment, an average of 17 months|One patient could not be optimally cytoreduced for HIPEC and therefore did not receive intraperitoneal chemotherapy.|||Months||Full Range|Median
2632549|NCT01833754|Primary|Intact Parathyroid Hormone (iPTH)Concentrations by Visit||Baseline, days 8, 15, 22, 29, 43, 57, and 85/end of study visit|All participants who received study drug and with available data at each time point|||pmol/L||Standard Deviation|Mean
2632550|NCT01833754|Primary|Albumin-Adjusted Serum Calcium Concentrations by Visit|"Albumin-adjusted calcium was derived as:~Where serum albumin < 40 g/L then albumin-adjusted calcium = measured total calcium (mmol/L) + 0.02 * [40 - serum albumin (g/L)]; Where serum albumin ≥ 40 g/L then albumin-adjusted calcium = measured total calcium."|Baseline, days 8, 15, 22, 29, 43, 57, and 85/end of study visit|All participants who received study drug|||mmol/L||Standard Deviation|Mean
2632551|NCT01833754|Primary|Number of Participants Who Developed Anti-Romosozumab Antibodies|"Two validated assays were used to detect the presence of anti-romosozumab antibodies. First, an electrochemiluminescent immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding romosozumab. Second, a non-cell-based competitive binding bioassay was used to test positive binding antibody samples for neutralizing activity against romosozumab.~If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the participant was defined as positive for neutralizing antibodies."|Baseline and day 85|All participants who received study drug|||Participants|||Count of Participants
2632552|NCT01833754|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)||Pre-dose on day -1 and on days 2, 3, 4, 6, 8, 11, 15, 18, 22, 29, 36, 43, 57 and 85|All participants were included in the analysis|||days*µg/mL||Standard Deviation|Mean
2632553|NCT01833754|Secondary|Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)||Pre-dose on day -1 and on days 2, 3, 4, 6, 8, 11, 15, 18, 22, 29, 36, 43, 57 and 85|All participants were included in the analysis|||days*µg/mL||Standard Deviation|Mean
2632554|NCT01833754|Secondary|Time to Maximum Observed Serum Concentration (Tmax) of Romosozumab||Pre-dose on day -1 and on days 2, 3, 4, 6, 8, 11, 15, 18, 22, 29, 36, 43, 57 and 85|All participants were included in the analysis|||days||Full Range|Median
2632555|NCT01833754|Secondary|Maximum Observed Serum Concentration (Cmax) of Romosozumab||Pre-dose on day -1 and on days 2, 3, 4, 6, 8, 11, 15, 18, 22, 29, 36, 43, 57 and 85|All participants were included in the analysis|||µg/mL||Standard Deviation|Mean
2632556|NCT01833754|Primary|Number of Participants With Adverse Events|"A serious adverse event was defined as an adverse event (AE) that met at least 1 of the following serious criteria:~fatal~life-threatening~required in-patient hospitalization or prolongation of existing hospitalization~resulted in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event. A treatment-related adverse event (TRAE) was an AE assessed by the investigator as possibly related to the study drug, indicated by a yes response to the question: Is there a reasonable possibility that the event may have been caused by the investigational product?"|From the first dose of study drug up to day 85|All participants who received study drug|||Participants|||Count of Participants
2632557|NCT01833741|Primary|Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia|Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy.|Week 12|All patients who were consented and completed the Baseline visit, and who had data for Week 12|||Percentage of Patients|||Number
2632558|NCT01833741|Primary|Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia|Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment.|Week 12|All patients who were consented and completed the Baseline visit, and who had data for Week 12|||Percentage of Patients|||Number
2632560|NCT01833741|Secondary|Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Week 6, Week 12|Intent to Treat: all patients who were consented and completed the Baseline visit|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2632561|NCT01833741|Secondary|Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Week 6, Week 12|Intent to Treat: all patients who were consented and completed the Baseline visit|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2632562|NCT01833741|Secondary|Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients|IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, Week 6, Week 12|Intent to Treat: all patients who were consented and completed the Baseline visit|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2632563|NCT01833741|Secondary|Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy|IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, 12 Weeks|Intent to Treat: all patients who were consented and completed the Baseline visit|||Percent Change||Standard Deviation|Mean
2632564|NCT01833741|Secondary|Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients|IOP is a measurement of the fluid pressure inside the eye. Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, 12 Weeks|Intent to Treat: all patients who were consented and completed the Baseline visit|||Percent Change||Standard Deviation|Mean
2632565|NCT01833741|Secondary|Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients|IOP is a measurement of the fluid pressure inside the eye. Naive patients did not use glaucoma medication prior to study entry. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase (worsening).|Baseline, 12 Weeks|Intent to Treat: all patients who were consented and completed the Baseline visit|||Percent Change||Standard Deviation|Mean
2632566|NCT01833741|Primary|Percentage of Treatment-Naive Patients With Ocular Hyperemia|Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Naive patients did not use glaucoma medication prior to study entry.|Week 12|All patients who were consented and completed the Baseline visit, and who had data for Week 12|||Percentage of Patients|||Number
2632567|NCT01833546|Secondary|Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 2 or Higher Than 2|ECOG performance status measured to assess subject's performance status on a scale of 0 to 5, where 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (more than 50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=Death. Number of participants with ECOG performance status score of 2 or higher than 2 were reported.|Baseline up to 33 months|Safety population included all participants who received at least 1 dose of the study drug (evofosfamide or gemcitabine).|||Participants|||Count of Participants
2632568|NCT01833546|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as Treatment Emergent Adverse Events (TEAEs)|Twelve-lead ECGs were performed and assessed after at least 5 minutes rest in supine position locally.|Baseline up to 33 months|Safety population included all participants who received at least 1 dose of the study drug (evofosfamide or gemcitabine).|||Participants|||Count of Participants
2632569|NCT01833546|Secondary|Number of Participants With Clinical Significant Laboratory Abnormalities and Vital Signs Abnormalities Reported as Treatment Emergent Adverse Events|Clinical laboratory parameters that were assessed included: hematological parameters, blood chemistry parameters, coagulation and urinalysis and the vital signs that were assessed included: blood pressure, heart rate, respiratory rate, and body temperature.|Baseline up to 33 months|Safety population included all participants who received at least 1 dose of the study drug (evofosfamide or gemcitabine).|||Participants|||Count of Participants
2632570|NCT01833546|Secondary|Number of Participants With Disease Control|Disease Control was defined as having achieved at least disease stabilization; that is participants with confirmed CR, PR, or SD lasting for at least 16 weeks. CR: Disappearance of all target lesions. PR: A decrease of at least 30% in the sum of the longest diameter of target lesions. PD: PD is defined as at least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. SD: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|Time from first treatment to final assessment at 33 months|Efficacy Analysis Set included all participants who received at least 1 planned dose of evofosfamide and who had a baseline tumor assessment and at least 1 tumor assessment according to RECIST version 1.1 after the first dose of study drug.|||Participants|||Count of Participants
2632604|NCT01833481|Primary|Kinematics - Overall Separation|Determine overall hip separation present in vivo in implanted hip during level walking activity under fluoroscopic surveillance|6 months post-operative||||mm||Standard Deviation|Mean
2632605|NCT01833481|Primary|Kinematics - Stance Phase Separation|Determine amount of stance phase hip separation present in vivo of implanted hip during level walking activity under fluoroscopic surveillance.|6 months post-operative||||mm||Standard Deviation|Mean
2632571|NCT01833546|Secondary|Number of Participants With Objective Response|OR was determined according to RECIST v1.1. Objective response is defined as a best overall response of confirmed complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Number of participants with OR were reported.|Time from first treatment to final assessment at 33 months|Efficacy Analysis Set included all participants who received at least 1 planned dose of evofosfamide and who had a baseline tumor assessment and at least 1 tumor assessment according to RECIST version 1.1 after the first dose of study drug.|||Participants|||Count of Participants
2632572|NCT01833546|Secondary|Best Overall Response (BOR)|BOR was determined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). BOR was defined as the best response of any of the confirmed complete response (CR), confirmed partial response (PR), stable disease (SD) and progressive disease (PD). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD was defined as at least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. Number of participants with CR, PR, SD and PD were reported.|Time from first treatment to final assessment at 33 months|Efficacy Analysis Set included all participants who received at least 1 planned dose of evofosfamide and who had a baseline tumor assessment and at least 1 tumor assessment according to RECIST version 1.1 after the first dose of study drug.|||Participants|||Count of Participants
2632573|NCT01833546|Secondary|Renal Clearance (CL) for Evofosfamide|Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time.|Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15|The PK Analysis Set included all participants who received at least 1 dose of evofosfamide (that is, actual total dose of evofosfamide > 0) and who provided sufficient data for a concentration-time profile for evofosfamide. Here “Number Analyzed” signifies those participants who were evaluated at the specified time point.|||Liter per hour per square meter||Geometric Coefficient of Variation|Geometric Mean
2632574|NCT01833546|Secondary|Cumulative Amount of Evofosfamide Excreted From Time Zero to Time After Dosing (Ae0-t)|Cumulative amount excreted in urine from time zero to the end of the last measurable concentration was reported.|Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15|The PK Analysis Set included all participants who received at least 1 dose of evofosfamide (that is, actual total dose of evofosfamide > 0) and who provided sufficient data for a concentration-time profile for evofosfamide. Here “Number Analyzed” signifies those participants who were evaluated at the specified time point.|||milligram per square meter||Geometric Coefficient of Variation|Geometric Mean
2632575|NCT01833546|Secondary|Apparent Volume of Distribution During Terminal Phase (Vz) of Gemcitabine|Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by elimination rate constant [λz]) following single dose. Area under the plasma concentration-time curve from time zero to infinity, calculated (AUC0-inf) as AUC0-t + AUCextra. AUCextra represents an extrapolated value obtained by Clast / λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured plasma concentration is at or above lower limit of quantification (LLQ) and λz is the elimination rate constant. And the elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data. This outcome was applicable for only combination arm in which evofosfamide was administered along with gemcitabine.|Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and 15|The PK Analysis Set included all participants who received at least 1 dose of gemcitabine (that is, actual total dose of gemcitabine > 0) and who provided sufficient data for a concentration-time profile for gemcitabine. Here “Number Analyzed” signifies those participants who were evaluated at the specified time point.|||Liter per square meter||Geometric Coefficient of Variation|Geometric Mean
2632576|NCT01833546|Secondary|Apparent Volume of Distribution During Terminal Phase (Vz) of Evofosfamide|Apparent volume of distribution during the terminal phase, calculated as Vz = Dose/AUC0-inf multiplied by elimination rate constant [λz]) following single dose. Area under the plasma concentration-time curve from time zero to infinity, calculated (AUC0-inf) as AUC0-t + AUCextra. AUCextra represents an extrapolated value obtained by Clast / λz, where Clast is the calculated serum concentration at the last sampling time point at which the measured plasma concentration is at or above lower limit of quantification (LLQ) and λz is the elimination rate constant. And the elimination rate constant obtained from linear regression of the terminal phase of the log transformed concentration-time data.|Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15|The PK Analysis Set included all participants who received at least 1 dose of evofosfamide (that is, actual total dose of evofosfamide > 0) and who provided sufficient data for a concentration-time profile for evofosfamide. Here “Number Analyzed” signifies those participants who were evaluated at the specified time point.|||Liter per square meter||Geometric Coefficient of Variation|Geometric Mean
2632577|NCT01833546|Secondary|Apparent Volume of Distribution at Steady State (Vss) of Gemcitabine|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) was the apparent volume of distribution at steady-state. This outcome was applicable for only combination arm in which evofosfamide was administered along with gemcitabine.|Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and 15|The PK Analysis Set included all participants who received at least 1 dose of gemcitabine (that is, actual total dose of gemcitabine > 0) and who provided sufficient data for a concentration-time profile for gemcitabine. Here “Number Analyzed” signifies those participants who were evaluated at the specified time point.|||Liter per square meter||Geometric Coefficient of Variation|Geometric Mean
2632606|NCT01833481|Primary|Kinematics - Swing Phase Separation|Determine amount of in vivo swing phase hip separation present within implanted hip during weight-bearing level walking while under fluoroscopic surveillance.|6 months post-operatively||||mm||Standard Deviation|Mean
2632578|NCT01833546|Secondary|Apparent Volume of Distribution at Steady State (Vss) of Evofosfamide|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) was the apparent volume of distribution at steady-state.|Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15|The PK Analysis Set included all participants who received at least 1 dose of evofosfamide (that is, actual total dose of evofosfamide > 0) and who provided sufficient data for a concentration-time profile for evofosfamide. Here “Number Analyzed” signifies those participants who were evaluated at the specified time point.|||Liter per square meter||Geometric Coefficient of Variation|Geometric Mean
2632579|NCT01833546|Secondary|Apparent Total Body Clearance of (CL) of Gemcitabine|Apparent total clearance (CL/F) was calculated as dose divided by area under the plasma concentration-time profile from time zero extrapolated to infinity (AUC[inf]). This outcome was applicable for only combination arm in which evofosfamide was administered along with gemcitabine.|Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and 15|The PK Analysis Set included all participants who received at least 1 dose of gemcitabine (that is, actual total dose of gemcitabine > 0) and who provided sufficient data for a concentration-time profile for gemcitabine. Here “Number Analyzed” signifies those participants who were evaluated at the specified time point.|||Liter per hour per square meter||Geometric Coefficient of Variation|Geometric Mean
2632580|NCT01833546|Secondary|Apparent Total Body Clearance of (CL) of Evofosfamide|Apparent total clearance (CL/F) was calculated as dose divided by area under the plasma concentration-time profile from time zero extrapolated to infinity (AUC[inf]).|Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15|The PK Analysis Set included all participants who received at least 1 dose of evofosfamide (that is, actual total dose of evofosfamide > 0) and who provided sufficient data for a concentration-time profile for evofosfamide. Here “Number Analyzed” signifies those participants who were evaluated at the specified time point.|||Liter per hour per square meter||Geometric Coefficient of Variation|Geometric Mean
2632581|NCT01833546|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) of Gemcitabine and Its Metabolite (2',2'-Difluorodeoxyuridine [dFdU])|Area under the concentration-time curve from time zero extrapolated to infinity, calculated as AUC(0-last) + last observed concentration (Clast)/terminal rate constant (λz), using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. Where AUC(0-last) is area under the concentration-time curve from time 0 to the last quantifiable concentration was assessed. λz was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. This outcome was applicable for only combination arm in which evofosfamide was administered along with gemcitabine.|Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and 15|The PK Analysis Set included all participants who received at least 1 dose of gemcitabine (that is, actual total dose of gemcitabine > 0) and who provided sufficient data for a concentration-time profile for gemcitabine. Here “Number Analyzed” signifies those participants who were evaluated at the specified time point.|||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2632582|NCT01833546|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC [0-infinity]) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])|Area under the concentration-time curve from time zero extrapolated to infinity, calculated as AUC(0-last) + last observed concentration (Clast)/terminal rate constant (λz), using the linear trapezoidal rule for increasing concentrations and the logarithmic rule for decreasing concentrations. Where AUC(0-last) is area under the concentration-time curve from time 0 to the last quantifiable concentration was assessed. λz was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.|Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15|The PK Analysis Set. Here “Number Analyzed” signifies those participants who were evaluated at the specified time point. There were no participants analyzed at certain time points (that is, Number Analyzed = 0) because there was no data collected for respective arms at those time points.|||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2632583|NCT01833546|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Sampling Time With Concentration at or Above the Lower Limit of Quantitation (AUC[0-t]) of Gemcitabine and Its Metabolite (2',2'-Difluorodeoxyuridine [dFdU])|Area under the concentration-time curve from time 0 to the last quantifiable concentration was assessed. This outcome was applicable for only combination arm in which evofosfamide was administered along with gemcitabine.|Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and 15|The PK Analysis Set included all participants who received at least 1 dose of gemcitabine (that is, actual total dose of gemcitabine > 0) and who provided sufficient data for a concentration-time profile for gemcitabine. Here “Number Analyzed” signifies those participants who were evaluated at the specified time point.|||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2632584|NCT01833546|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Sampling Time With Concentration at or Above the Lower Limit of Quantitation (AUC[0-t]) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])|Area under the concentration-time curve from time 0 to the last quantifiable concentration was assessed.|Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15|The PK Analysis Set included all participants who received at least 1 dose of evofosfamide (that is, actual total dose of evofosfamide > 0) and who provided sufficient data for a concentration-time profile for evofosfamide. Here “Number Analyzed” signifies those participants who were evaluated at the specified time point.|||ng*hour per mL (ng*hour/mL)||Geometric Coefficient of Variation|Geometric Mean
2635092|NCT01807624|Primary|Half-life of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||minutes||Standard Deviation|Mean
2632585|NCT01833546|Secondary|Apparent Terminal Half-life (t1/2) of of Gemcitabine and Its Metabolite (2',2'-Difluorodeoxyuridine [dFdU])|Terminal half-life was calculated as ln(2)/λz. Where λz is a Terminal rate constant, which was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. This outcome was applicable for only combination arm in which evofosfamide was administered along with gemcitabine.|Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and 15|The PK Analysis Set included all participants who received at least 1 dose of gemcitabine (that is, actual total dose of gemcitabine > 0) and who provided sufficient data for a concentration-time profile for gemcitabine. Here “Number Analyzed” signifies those participants who were evaluated at the specified time point.|||hours||Geometric Coefficient of Variation|Geometric Mean
2632586|NCT01833546|Secondary|Apparent Terminal Half-life (t1/2) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])|Terminal half-life was calculated as ln(2)/λz. Where λz is a Terminal rate constant, which was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.|Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15|The PK Analysis Set. Here “Number Analyzed” signifies those participants who were evaluated at the specified time point. There were no participants analyzed at certain time points (that is, Number Analyzed = 0) because there was no data collected for respective arms at those time points.|||hours||Geometric Coefficient of Variation|Geometric Mean
2632587|NCT01833546|Secondary|Terminal Rate Constant Associated With the Terminal Elimination Phase (λz) of Gemcitabine and Its Metabolite (2',2'-Difluorodeoxyuridine [dFdU])|Terminal rate constant was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve. This outcome was applicable for only combination arm in which evofosfamide was administered along with gemcitabine.|Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and 15|The PK Analysis Set included all participants who received at least 1 dose of gemcitabine (that is, actual total dose of gemcitabine > 0) and who provided sufficient data for a concentration-time profile for gemcitabine. Here “Number Analyzed” signifies those participants who were evaluated at the specified time point.|||Per hour||Geometric Coefficient of Variation|Geometric Mean
2632588|NCT01833546|Secondary|Terminal Rate Constant Associated With the Terminal Elimination Phase (λz) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])|Terminal rate constant was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.|Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15|The PK Analysis Set. Here “Number Analyzed” signifies those Participants who were evaluated at the specified time point. There were no Participants analyzed at certain time points (that is, Number Analyzed = 0) because there was no data collected for respective arms at those time points.|||Per hour||Geometric Coefficient of Variation|Geometric Mean
2632589|NCT01833546|Secondary|Maximum Observed Plasma Concentration (Cmax) of Gemcitabine and Its Metabolite (2',2'-Difluorodeoxyuridine [dFdU])|Maximum observed Plasma concentration was assessed. This outcome was applicable for only combination arm in which evofosfamide was administered along with gemcitabine.|Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and 15|The PK Analysis Set included all Participants who received at least 1 dose of gemcitabine (that is, actual total dose of gemcitabine > 0) and who provided sufficient data for a concentration-time profile for gemcitabine. Here “Number Analyzed” signifies those Participants who were evaluated at the specified time point.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2632590|NCT01833546|Secondary|Maximum Observed Plasma Concentration (Cmax) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])|Maximum observed plasma concentration was assessed.|Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15|The PK Analysis Set included all participants who received at least 1 dose of evofosfamide (that is, actual total dose of evofosfamide > 0) and who provided sufficient data for a concentration-time profile for evofosfamide. Here “Number Analyzed” signifies those participants who were evaluated at the specified time point.|||Nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2632591|NCT01833546|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Gemcitabine and Its Metabolite (2',2'-Difluorodeoxyuridine [dFdU])|Tmax was the time to peak concentration in plasma, obtained directly from the concentration versus time curve. This outcome was applicable for only combination arm in which evofosfamide was administered along with gemcitabine.|Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and 15|The PK Analysis Set included all participants who received at least 1 dose of gemcitabine (that is, actual total dose of gemcitabine > 0) and who provided sufficient data for a concentration-time profile for gemcitabine. Here “Number Analyzed” signifies those participants who were evaluated at the specified time point.|||hours||Full Range|Median
2632592|NCT01833546|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])||Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15|The Pharmacokinetics (PK) Analysis Set included all participants who received at least 1 dose of evofosfamide (that is, actual total dose of evofosfamide > 0) and who provided sufficient data for a concentration-time profile for evofosfamide. Here “Number Analyzed” signifies those participants who were evaluated at the specified time point.|||hours||Full Range|Median
2632607|NCT01833455|Other Pre-specified|Change in Baroreflex Gain|Arterial baroreflex gain is calculated as slope of the relationship between cardiac cycle length and the corresponding change in systolic blood pressure.|Baseline and 28 days|Arterial baroreflex gain values were not available at all time points. In one subject, gain could not be calculated because they were in bigeminy. Data on subjects who completed the study is presented here and may not reflect changes seen in a larger population.|||ms/mmHg||Standard Deviation|Mean
2632593|NCT01833546|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs, TEAEs Leading to Death|AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are events with start date on or after the date of first dose of study treatment and up to and including 30 days after the last dose of study treatment, or events with start date prior to the date of first dose of study treatment, and worsened in severity or become serious during treatment. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline up to 33 months|Safety population included all participants who received at least 1 dose of the study drug (evofosfamide or gemcitabine).|||Participants|||Count of Participants
2632594|NCT01833546|Primary|Number of Participants Who Experienced Any Dose-Limiting Toxicity (DLT) During First Cycle - Day 1 to 28|A DLT was defined as any of the following toxicities at any dose level that occurred during the first cycle, and were considered to be related to the study drug by the Investigator or the Sponsor: - Grade 3 or Grade 4 non-hematological toxicity, except for Grade 3 or Grade 4 nausea, vomiting and diarrhea, - Grade 3 or higher skin reactions or mucosal toxicities, - Febrile neutropenia, - Grade 3 alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevation lasting more than 7 days, - Grade 4 neutropenia lasting more than 5 days, - Grade 4 thrombocytopenia, - Grade 4 anemia, - Any non-preexisting Grade 2 or higher non-hematologic toxicity which, in the judgment of the Investigator and the Sponsor, was considered a DLT, - Any Grade 2 or higher non-hematologic toxicity that did not resolve to Grade 0 or Grade 1 toxicity by the start of the next cycle which, in the judgment of the Investigator and the Sponsor, was considered a DLT.|Day 1 up to Day 28 of Cycle 1|The DLT Analysis Set included all participants who experienced a DLT during Cycle 1 or who did not experience a DLT, completed Cycle 1 and received 90% or more of all planned total dose of evofosfamide, and gemcitabine for the combination, during Cycle 1.|||Participants|||Count of Participants
2632595|NCT01833533|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI calculated using the normal approximation to the binomial distribution.|Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)|All randomized participants who received at least 1 dose of study drug (ITT population) with HCV RNA < LLOQ at the final treatment visit and completed treatment.|||percentage of participants||95% Confidence Interval|Number
2632596|NCT01833533|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12|All randomized participants who received at least 1 dose of study drug (ITT population).|||percentage of participants|||Number
2632597|NCT01833533|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses|"The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.~The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (ITT population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
2632598|NCT01833533|Secondary|Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment|The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.|Baseline (Day 1) and Week 12 (End of Treatment)|All randomized participants who received at least 1 dose of study drug (ITT population) and had hemoglobin ≥ LLN reference range at baseline.|||percentage of participants|||Number
2632599|NCT01833533|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.~The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1a infection treated with telaprevir and peginterferon(pegIFN)/RBV."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (intent-to-treat [ITT] population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
2632600|NCT01833494|Secondary|Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)||52 weeks|Full Analysis Set|||pg/mL||Standard Deviation|Mean
2632601|NCT01833494|Secondary|Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)||52 weeks|Full Analysis Set|||mg/dL||Standard Deviation|Mean
2632602|NCT01833494|Secondary|Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)||52 weeks|Full Analysis Set|||mg/dL||Standard Deviation|Mean
2632603|NCT01833494|Primary|Incidence of Adverse Events||52 weeks|Safety Set|||Participants|||Count of Participants
2632608|NCT01833455|Secondary|Change in Muscle Sympathetic Nerve Activity|Muscle sympathetic nerve activity was measured as number of bursts of neural activity per 100 heart beats.|Baseline and 28 days|SNA values were not obtained in many of the participants in various groups above due to technical difficulties. Data on subjects who underwent the measurement are presented here and may not reflect changes seen in a larger population.|||bursts / 100 heartbeats|||Number
2632609|NCT01833455|Primary|Change in Mean Arterial Pressure|Mean arterial blood pressure was calculated from non-invasive systolic and diastolic arm measurements.|Baseline and 28 days|Mean arterial blood pressure values were not available at all time points for every patient. Data on subjects who completed the study is presented here and may not reflect changes seen in a larger population.|||mmHg||Standard Deviation|Mean
2632610|NCT01833403|Primary|Insulin Sensitivity|Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test. Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 150-180 minute interval of the clamp|1 month||||mg glucose /kg FFM/min||Standard Error|Mean
2632611|NCT01833403|Primary|Insulin Sensitivity||Baseline||||m value||Standard Deviation|Mean
2632612|NCT01833247|Post-Hoc|Salivary and Capillary Lactic Acid Will be Correlated After a Seizure|Salivary levels of lactic acid is being studied because saliva is more accessible in the outpatient setting than is blood. Concentration of lactic acid in the serum and saliva from each individual subject will be correlated using Pearson's correlation test. We will consider a positive outcome to be a r greater than or equal to 0.5 and significance at p<0.05.|Within 10 minutes of a seizure|||||||
2632613|NCT01833247|Primary|Intravenous Lactic Acid Levels With Seizures|The investigators will assess the intravenous lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in serum collected by IV, immediately post-seizure. Units of measurement will be mM/L. A positive outcome will be a curve different from a straight line, with a rise and fall of lactate levels. Baseline lactate serum level is expected to be less than 2.2 mM/L.|Within 10 minutes of end of the seizure|Data were collected from one participant|||mmol/L|||Number
2632614|NCT01833247|Primary|Capillary Lactic Acid Levels With Seizures|The investigators will assess the capillary lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in blood, within 10 minutes after the end of a seizure. Units of measurement will be mM/L. Baseline lactate serum level is expected to be less than 2.2 mM/L.|Within 10 minutes of end of the seizure|Data were collected from 6 of the 12 enrolled subjects|||mmol/L||Standard Deviation|Mean
2632615|NCT01833247|Primary|Salivary Lactic Acid Levels With Seizures|The investigators will assess the salivary lactic acid within 10 minutes after end of a seizure. Values will consist of lactic acid measurements in saliva , immediately post-seizure. Units of measurement will be mM/L. A positive outcome will be a curve different from a straight line, with a rise and fall of lactate levels. Baseline lactate serum level is expected to be less than 2.2 mM/L.|Within 10 minutes of end of the seizure||||mmol/L||Standard Deviation|Mean
2632616|NCT01833169|Secondary|Overall Survival (OS)- Kaplan-Meier Estimates of OS Rate in Percentages|Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact|baseline up to 30 months||||percentage of participants||95% Confidence Interval|Number
2632617|NCT01833169|Secondary|Overall Survival (OS)- Kaplan-Meier Estimates of OS Timing in Months|Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact|baseline up to 24 months||||months||95% Confidence Interval|Median
2632618|NCT01833169|Secondary|Overall Survival - Number of Participants With an Event|Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact|Every 8 Weeks until death, assessed up to 24 months||||participants|||Number
2632619|NCT01833169|Secondary|Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Rate in Percentages|Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause.|baseline up to 24 months||||percentage of participants||95% Confidence Interval|Number
2632620|NCT01833169|Secondary|Progression-Free Survival (PFS)- Kaplan-Meier Estimates of PFS Timing in Months|Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause|baseline up to 24 months||||months||95% Confidence Interval|Median
2632621|NCT01833169|Secondary|Progression-Free Survival - Number of Participants With an Event|Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause|Every 8 Weeks until death, assessed up to 24 months||||participants|||Number
2632622|NCT01833169|Secondary|Overall Response of Partial Response (PR) or Greater. PR=at Least a 30% Decrease in the Sum of Diameters of Target Lesions, Taking as Reference the Baseline Sum Diameters|Overall Response (OR) of Partial Response (PR) or greater is based on local investigator assessment. For patients with solid tumors, the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. For hematologic tumors other appropriate hematological response criteria apply|baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months||||percentage of patients||95% Confidence Interval|Number
2632623|NCT01833169|Primary|Participant Clinical Benefit Response Rate|Clinical benefit rate for patients with solid tumors will be assessed using RECIST 1.1 and will include responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) at >=16 weeks. For hematologic tumors other appropriate hematological response criteria was applied. Response criteria: CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm., PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study, PD= At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline|Week 16||||percentage of participants||95% Confidence Interval|Number
2632624|NCT01833130|Secondary|Change From Baseline in the Emotional Function (EF) Domain of the MSQ|The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The EF domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the EF.|Baseline, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
2632625|NCT01833130|Secondary|Change From Baseline in the Role Function-Preventive (RP) Domain of the MSQ|The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The RP domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the RP.|Baseline, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
2632626|NCT01833130|Secondary|Change From Baseline in the Role Function-Restrictive (RR) Domain of the Migraine Specific Questionnaire (MSQ)|The MSQ is 14 question scale that measures health-related impairments attributed to migraines over the past 4 weeks. The RR domain score ranges from 0 (no symptoms) to 100 (symptoms experienced all the time). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the RR.|Baseline, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
2632627|NCT01833130|Secondary|Change From Baseline in the Headache Impact Test-6 (HIT-6) Questionnaire Total Score|The HIT-6 is a 6 question 5-point scale used to measure the impact of headaches on daily life. The total score ranged from 36 (no impact) to 78 (worst impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.|Baseline, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
2632628|NCT01833130|Secondary|Change From Baseline in the General Impact (GEN-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The GEN-I is a subdomain on the ACM-I. The GEN-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the GEN-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
2632629|NCT01833130|Secondary|Change From Baseline in the Cognitive Impact (COG-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The COG-I is a subdomain on the ACM-I. The COG-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the COG-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
2632630|NCT01833130|Secondary|Change From Baseline in the Energy Impact (ENE-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The ENE-I is a subdomain on the ACM-I. The ENE-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ENE-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
2632631|NCT01833130|Secondary|Change From Baseline in the Household Activities Impact (HOS-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The HOS-I is a subdomain on the ACM-I. The HOS-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the HOS-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
2632632|NCT01833130|Secondary|Change From Baseline in the Leisure Activities Impact (LEA-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The LEA-I is a subdomain on the ACM-I. The LEA-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the LEA-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
2632633|NCT01833130|Secondary|Change From Baseline in the Social Impact (SOC-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The SOC-I is a subdomain on the ACM-I. The SOC-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the SOC-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
2632634|NCT01833130|Secondary|Change From Baseline in the Work/School Impact (WS-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The WS-I is a subdomain on the ACM-I. The WS-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the WS-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
2632635|NCT01833130|Secondary|Change From Baseline in the Emotions Impact (EMO-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The EMO-I is a subdomain on the ACM-I. The EMO-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the EMO-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
2635093|NCT01807624|Primary|Tmax of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||minutes||Standard Deviation|Mean
2632636|NCT01833130|Secondary|Change From Baseline in the Activities of Daily Living Impact (ADL-I) Domain of the ACM-I Questionnaire|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The ADL-I is a subdomain on the ACM-I. The ADL-I score ranged from 0 (lowest impact) to 100 (highest impact). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ADL-I.|Baseline, Week 12, Week 22, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
2632637|NCT01833130|Secondary|Change From Baseline in the Symptom Experience Score (SES) Subdomain of the ACM-S Questionnaire|The ACM-S is 12 question migraine symptom scale over the past 24 hours. The SES subdomain score ranges from 0 (no symptoms) to 12 (all symptoms experienced). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ACM-S SES.|Baseline, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
2632638|NCT01833130|Secondary|Change From Baseline in the Symptom Severity Score (SSS) Subdomain of the Assessment of Chronic Migraine Symptoms (ACM-S) Questionnaire|The ACM-S is 12 question migraine symptom scale over the past 24 hours. The SSS subdomain score ranges from 0 (no symptoms) to 100 (more severe symptoms). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening in the ACM-S SSS.|Baseline, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
2632639|NCT01833130|Primary|Change From Baseline in the Assessment of Chronic Migraine Impacts (ACM-I) Questionnaire Total Score|The ACM-I is a 24 question scale used to measure the impact of chronic migraine on daily activities and patient-treatment benefit over the past 7 days. The total score ranged from 0 (lower impact chronic migraine) to 100 (highest impact chronic migraine). A negative number change from baseline indicates an improvement, and a positive number change from baseline indicates a worsening.|Baseline, Week 24|Intent-to-Treat: all randomized patients|||Scores on a Scale||Standard Deviation|Mean
2632640|NCT01833117|Secondary|Area Under Curve (AUC) of TBUT From 0 to 60 Minutes|Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 5, 15, 30, and 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used.|0 to 60 minutes|This analysis population includes all randomized participants.|||seconds x hours||Standard Deviation|Mean
2632641|NCT01833117|Primary|Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes|Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used.|Baseline, 60 minutes|This analysis population includes all randomized participants.|||seconds||Standard Error|Mean
2632642|NCT01833078|Secondary|Sustainability of Increased Caloric Intake|Sustained food intake of standardized meal from Days 1 compared to Day 7.|pre-treatment baseline (day 1) through day 7||||calories||Full Range|Median
2632643|NCT01833078|Primary|Safety|1.Safety: # of participants with treatment emergent adverse events|pre-treatment baseline through 30 days following the last administration of study treatment day 7||||participants|||Number
2632644|NCT01833065|Secondary|Change From Baseline in Weekly Abdominal Discomfort Score|"The abdominal discomfort score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).~For a given assessment week, the weekly abdominal discomfort score was defined as the sum of non-missing abdominal discomfort score for SBMs during that week divided by the number of non-missing abdominal discomfort score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2632645|NCT01833065|Secondary|Change From Baseline in Weekly Abdominal Bloating Score|"The abdominal pain score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).~For a given assessment week, the weekly abdominal bloating score was defined as the sum of non-missing abdominal bloating score for SBMs during that week divided by the number of non-missing abdominal bloating score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2632646|NCT01833065|Secondary|Change From Baseline in Weekly Degree of Straining of SBMs|"The degree of straining was measured using the five-point ordinal scale (1=Not at all, 2=A little bit, 3=A moderate amount, 4=A great deal, and 5=An extreme amount).~For a given assessment week, the weekly degree of straining was defined as the sum of non-missing straining score for SBMs during that week divided by the number of non-missing straining score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2632659|NCT01832961|Primary|Airways Resistance (IOS) - Reactance Area (Ax)|Airways resistance were measured by impulse oscillometry (IOS) method.|Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest|No data was collected from the Flutter-sham Control group after 20 minutes of rest.|||kPa/L||Standard Deviation|Mean
2633129|NCT01829048|Primary|Sparse Pharmacokinetic (PK) Sampling for Population PK Analysis: PF-02545920 Concentration at 0 Hour (Predose) on Day 10 (Cohorts 1 and 2)||0 hour (predose) on Day 10|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2632647|NCT01833065|Secondary|Total Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score Responder|"This outcome measured the percentage of patients who were PAC-QOL score responder at 12-week Treatment Period. A PAC-QOL score responder was defined as a patient with ≥50% reduction in total PAC-QOL score from Baseline at Week 12.~PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific quality of life. The questionnaire is based on 5-point Likert scale; ranging from 0 [none of the time or not at all] to 4 [all of the time or extremely]). A lower score indicates a better Quality of Life. The PAC-QOL questionnaire is developed specifically for patients with constipation.~Total PAC-QOL score was averaged from the individual item score."|At Week 12|The ITT analysis set consisting of all randomized (as planned) patients.|||Percentage of patients|||Number
2632648|NCT01833065|Secondary|Change From Baseline in Weekly Stool Consistency of SBMs|"The stool consistency is measured using the seven-point ordinal Bristol Stool Form Scale (BSFS) score. The BSFS classifies human stool into seven types and points them accordingly.~Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 represents the ideal stool form (especially the latter), and 5, 6 and 7 tends towards diarrhoea .~For a given assessment week, the weekly stool consistency was defined as the sum of non-missing stool consistency score for SBMs during that week divided by the number of non-missing stool consistency score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.|||Units on BSFS||95% Confidence Interval|Least Squares Mean
2632649|NCT01833065|Secondary|Change From Baseline in Weekly Frequency of Spontaneous Bowel Movement (SBMs)|The change from Baseline for the continuous variable was estimated using a repeated measures analysis of covariance (ANCOVA) model.|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisting of all randomized (as planned) patients.|||SBM per week||95% Confidence Interval|Least Squares Mean
2632650|NCT01833065|Secondary|Occurrence of CSBM Response|This outcome measured the percentage of patients who had a CSBM within 24 hours after the first dose of treatment. A CSBM was defined as a spontaneous (occurring without laxative within the preceding 24 hours, including no rescue medication within the preceding 24 hours) bowel movement (as interpreted by the patient, with a beginning and an end, including single or multiple stools), accompanied by a patient reported sense of complete evacuation ('complete').|Within first 24 hours of treatment initiation|The ITT analysis set consisting of all randomized (as planned) patients.|||Percentage of patients|||Number
2632651|NCT01833065|Primary|Overall Complete Spontaneous Bowel Movement (CSBM) Response|This outcome measured the percentage of patients who were CSBM responders. A CSBM responder was defined as a patient with ≥3 CSBMs per week and an increase of ≥1 CSBM per week from Baseline, for at least 9 of the 12 weeks in the 12-week Treatment Period, including at least 3 weeks during Weeks 9-12.|During the first 12 weeks|The ITT analysis set consisting of all randomized (as planned) patients.|||Percentage of patients|||Number
2632652|NCT01833026|Primary|Number of Participants With Accurate Classification of Irreversible Airflow Obstruction|accuracy of diagnosis was the outcome measure. The results of the spirometry test (done in the beginning for the intervention group and ant the end of 1 year for the usual care groups) were reviewed in conjunction with the initial physician diagnosis of COPD and/or asthma to confirm whether the diagnosis was accurate, not accurate, or indeterminate. Accuracy of diagnosis of COPD was determined by spirometry results if the FEV1/FVC ratio was <0.7.|spirometry was performed at the first visit for intervention group and at 1 year from recruitment for the usual care group, one time assessment for both groups||||Participants|||Count of Participants
2632653|NCT01832961|Secondary|Secretion - Purulence Score|"The expectorated secretion was collected, weighted and classified with a purulence score based on a previously described numerical visual scale, which ranges from 1 (mucoid) to 5 (yellow/green).~Referee of the Purulence score: Barnes PJ, Dweik RA, Gelb AF, et al. Exhaled nitric oxide in pulmonary diseases: a comprehensive review. Chest. 2010;138:682-692."|In each session|COPD patients without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of a rib fracture or pneumothorax.|||score on a scale||Standard Deviation|Mean
2632654|NCT01832961|Secondary|Secretion - Volume|Expectorated secretion volume during each visit were collected, weighted and classified with a purulence score.|During each session|"COPD patients without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of a rib fracture or pneumothorax~The volume fo secretion was obtained only for two groups: Flutter exercises and flutter-sham exercises."|||grams||Standard Deviation|Mean
2632655|NCT01832961|Secondary|Cough|Number of spontaneously reported cough episodes during each visit were collected.|During each session|Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of rib fracture or pneumothorax.|||Coughs||Standard Deviation|Mean
2632656|NCT01832961|Secondary|Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)|Forced expiratory volume in 1s (FEV1) and forced vital capacity (FVC) were measured using a dry wedge spirometer (Jaeger Co, Wurzburg, Germany)|Baseline and immediately after intervention|Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of rib fracture or pneumothorax.|||percent predicted spirometry assessment||Standard Deviation|Mean
2632657|NCT01832961|Secondary|Exhaled Nitric Oxide (FeNO)|Exhaled nitric oxide will be measured by chemiluminescence method.|Baseline and immediately after intervention|Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of rib fracture or pneumothorax.|||parts per billion||Standard Deviation|Mean
2632658|NCT01832961|Primary|Airways Resistance (IOS) - Resonant Frequency (Fres)|Airways resistance were measured by impulse oscillometry (IOS) method.|Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest|No data was collected from the Flutter-sham Control group after 20 minutes of rest.|||Hz||Standard Deviation|Mean
2632660|NCT01832961|Primary|Airways Resistance (IOS)|Airways resistance were measured by impulse oscillometry (IOS) method.|Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest|"Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis, and no recent history of rib fractures or pneumothorax.~In the Flutter-sham Control group after 20 minutes of rest - no data was collected."|||kPa/L/s||Standard Deviation|Mean
2632661|NCT01832818|Secondary|Absence of Device Migration or Subsidence|Absence of device migration > 3mm; Absence of device subsidence > 3mm|Up to 24 months||||Participants|||Count of Participants
2632662|NCT01832818|Secondary|Patient Satisfaction|As assessed on patient questionnaire.|At 24 months||||Participants|||Count of Participants
2632663|NCT01832818|Primary|Device Failures or Removals, Revisions, Re-operations|The failures or re-operations or supplemental fixation at the treated level|Up to 24 months||||Participants|||Count of Participants
2632664|NCT01832818|Primary|Serious Adverse Events Related to the Device|The number of serious adverse events have been recorded|Up to 24 months||||Participants|||Count of Participants
2632665|NCT01832818|Primary|Visual Analog Scale (VAS) Improvement of 2.0 cm for Neck Pain|"The pain Visual Analog Scale is a uni-dimensional measure of pain intensity, represented by a 100 mm line, anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 [100-mm scale]). A higher score would indicate that the patient had a worse outcome."|At 24 months||||units on a scale||Standard Deviation|Mean
2632666|NCT01832818|Primary|Neck Disability Index (NDI) Score Improvement of at Least 15 Points|The Neck Disability Index is a patient reported outcome measure for self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score. A higher score would indicate that the patient did not improve.|At 24 months||||units on a scale||Standard Deviation|Mean
2632667|NCT01832766|Other Pre-specified|Brief Psychiatric Rating Scale Change From Baseline at 1 Hour|Measures psychiatric symptoms. Each item is scored from 1-7. Positive symptoms are calculated from sum of scores on hallucinatory behavior, unusual thought content and conceptual disorganization. Thus, the range of Total Positive Symptoms can be from a score of 3-21 .The higher the score, the more severe the symptom. Negative symptoms have been calculated from sum of blunted affect, emotional withdrawal and motor retardation. The range of Total Negative Symptoms can be from a score of 3-21. The higher the score, the more severe the symptoms. As this is a difference from baseline, there can be either negative or positive results as the subjects can either be better than baseline (positive score) or worse than baseline (negative score).|at 1 hour after drug administration|One participant did not complete the treatment or the placebo arm (crossover study design).|||units on a scale||Standard Deviation|Mean
2632668|NCT01832766|Secondary|California Verbal Learning Test Change at 2 Hours From Baseline|ability to remember a list of words given 5 trials. Number of words remembered is normalized to a schizophrenia population and average scores are calculated with age correction. The normal T-score is 50 and scores greater than 50 correspond with greater ability to remember words as compared to a schizophrenia population norm.|2 hours after drug administration|One participant did not complete the treatment or the placebo arm (crossover study design).|||T scores||Standard Deviation|Mean
2632669|NCT01832766|Primary|P50 Auditory Evoked Potential|electrophysiological measure of ability to filter extraneous stimuli measured as the amplitude of the evoked response to the second auditory stimulus divided by the amplitude of the evoked response to the first auditory stimulus in mV.|2 hours after drug administration|One participant did not complete the treatment or the placebo arm (crossover study design).|||test to conditioning ratio||Standard Deviation|Mean
2632670|NCT01832753|Secondary|Change in Quality of Life From Baseline at 6, 12 and 18 Months.|"Questionnaires will be done with participants and parents on the day of each study visit to determine body image and quality of life. The Pediatric Quality of Life (PedsQL) scale is a 5-item scale (values 1-5). 1 - Always True, to 5 - Never True. Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that greater scores indicate better QOL."|baseline, 6 months, 12 months, & 18 months|"3 of the 12 participants (Observation Only) were withdrawn prior to randomization due to normal TSH. 1 of the 4 Delayed Treatment group participants self-withdrew before their 12 month visit. 1 of the 5 Immediate Treatment participants withdrew due to elevated TSH at their 12 month visit, 1 and self-withdrew before their 12 month visit."|||Unit on a scale, linearly transformed||Full Range|Median
2632671|NCT01832753|Primary|Change in Lipid Panel From Baseline at 6, 12 and 18 Months.|Lipid panel will be measured via fasting blood draw.|baseline, 6 months, 12 months & 18 months|"3 of the 12 participants (Observation Only) were withdrawn prior to randomization due to normal TSH. 1 of the 4 Delayed Treatment group participants self-withdrew before their 12 month visit. 1 of the 5 Immediate Treatment participants withdrew due to elevated TSH at their 12 month visit, 1 and self-withdrew before their 12 month visit."|||mg/dL||Inter-Quartile Range|Median
2632672|NCT01832610|Secondary|Change in Functional Status Measured by 6-minute Walk|Change in functional status, as measured by 6-minute walk test. A positive change in score from baseline indicates an improvement.|Change from baseline to 5 years|Participants who enrolled into the trial on device are included. Subjects also had to reach the Month 60 visit and complete the assessment or indicate Not Completed to be analyzed at both the baseline and Month 60 visits. If the subject did not complete the assessment, a value of 0 was imputed.|||Meters||Standard Deviation|Mean
2632673|NCT01832610|Secondary|Change in Functional Status Measured by New York Heart Association (NYHA) Class|"Change in Functional status, as measured by New York Heart Association (NYHA) class. There are 4 levels of NYHA:~I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea.~II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.~III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea.~IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.~Improvement is defined as moving from a higher numerical NYHA level to a lower numerical NYHA level (e.g., IV to III)."|Change from baseline to 5 years|Participants who enrolled into the trial on device were included. Participants also had to reach the Month 60 visit and complete the assessment to be analyzed.|||Participants|||Count of Participants
2632674|NCT01832610|Secondary|Health Status Change Measured by EuroQol EQ-5D (Version 5L)|The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worse imaginable health state) to 100 (best imaginable health state).|Enrollment to 5 years|Participants who enrolled into the trial on device are included. Participants also had to reach the Month 60 visit complete the assessment to be analyzed.|||score on a scale||Standard Deviation|Mean
2632675|NCT01832610|Secondary|Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)|Health Status change as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score. The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (e.g., better functioning, fewer symptoms, better quality of life). The Overall Summary Score is calculated as the mean of the Physical Limitation, Total Symptom, Quality of Life and Social Limitation scores. A positive change in score from baseline indicates an improvement.|Change from baseline to 5 years|Participants who enrolled into the trial on device are included. Participants also had to reach the Month 60 visit and complete both the baseline and Month 60 assessments to be analyzed.|||score on a scale||Standard Deviation|Mean
2632676|NCT01832610|Secondary|Number of Participants Experiencing Any Adverse Event Per Intermacs Definition|Number of participants with an Intermacs adverse event, per the Intermacs definitions. An adverse event is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the medical device.|Enrollment into HW-PAS-03 to 5 years|Participants who enrolled into the trial on device are included.|||Participants|||Count of Participants
2632677|NCT01832610|Secondary|Re-hospitalizations|A summary of the number of re-hospitalizations per participant from enrollment into HW-PAS-03 throughout their participation in the study.|Enrollment into HW-PAS-03 to 5 years|Participants who enrolled into the trial on device are included.|||Re-hospitalizations||Standard Deviation|Mean
2632678|NCT01832610|Secondary|Final Patient Status|The number and percentage of participants with a given outcome (e.g., alive on device, transplant, death, etc.) as of their last follow up or end of study, whichever occurred first.|Implant to 5 years|All enrolled subjects are included.|||Participants|||Count of Participants
2632679|NCT01832610|Primary|Overall Survival on Device|Overall survival is the probability (expressed as a percent of 100) the participant did not die within 5 years post implant via the Kaplan-Meier method. Participants that did not die were censored at the time of last follow-up or their end of study at 5 years post implant, whichever occurred first.|Implant to 5 years|All enrolled subjects are included|||Percent Probability of Survival|||Number
2632680|NCT01832506|Secondary|Progression-free Survival (PFS)|"PFS was defined as the time in months from the first administration of trial treatment until first observation of progressive disease (PD), or death due to any cause when death occurs within 12 weeks of the last tumor assessment or first administration of trial treatment (whichever is later). Any subject with neither assessment of tumor progression, nor death within 12 weeks after last tumor assessment date was censored on the date of last tumor assessment. PFS was planned to be presented for MSC2156119J Combined reporting arm."|Day 21 of Cycle 2 and each subsequent cycle up to a maximum of 51.1 weeks|Safety analysis set included all subjects who had received at least 1 dose of the IMP.|||months||90% Confidence Interval|Median
2632681|NCT01832506|Secondary|Number of Subjects With Clinical Benefit|Clinical Benefit was defined as CR or PR at any time point or SD at week 12 or later, based on tumor assessment as determined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study. PD: defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions.|Day 21 of Cycle 2 and each subsequent cycle up to a maximum of 51.1 weeks|Safety analysis set included all subjects who had received at least 1 dose of the IMP.|||subjects|||Number
2632682|NCT01832506|Secondary|Number of Subjects With Best Overall Response (BOR)|Number of subjects with BOR in each category (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) was reported. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: defined as at least a 30% decrease in sum of longest diameter of target lesions, taking as reference the baseline sum of longest diameter. PD: defined as at least a 20% increase in sum of longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameter while on study.|Day 21 of Cycle 2 and each subsequent cycle up to a maximum of 51.1 weeks|Safety analysis set included all subjects who had received at least 1 dose of the IMP.|||subjects|||Number
2632683|NCT01832506|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time t (AUC0-t) After Multiple Dose of MSC2156119J|Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration is at or above the LLQ. AUC0-t was calculated according to the mixed log-linear trapezoidal rule|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome at the specified time point for each arm, respectively.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2668599|NCT01504867|Secondary|Mean Number of Days Participants Were Ventilator-Free To Day 28||baseline, Day 28|Intention-to-Treat|||days||Standard Deviation|Mean
2632684|NCT01832506|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time t (AUC0-t) After Single Dose of MSC2156119J|Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration is at or above the lower limit of quantification (LLQ) AUC0-t was calculated according to the mixed log-linear trapezoidal rule|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had completed Cycle 1 without any relevant protocol violations with respect to factors that were likely to affect the PK results and who received at least first dose of study drug according to the protocol providing sufficient concentration time data to determine the PK endpoints for the study drug.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2632685|NCT01832506|Secondary|Apparent Volume of Distribution Associated To The Terminal Phase (Vz/f) of MSC2156119J|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed and is calculated by Dose/(AUC(inf)*λz).|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of the Vz/f.||||||
2632686|NCT01832506|Secondary|Apparent Body Clearance (CL/f) of MSC2156119J|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. CL/F = Dose/AUC(inf), where AUC(inf) =AUC0-t + AUCextra. AUCextra represented an extrapolated value obtained by Clast/λz, where Clast was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the LLQ and λz is the terminal elimination rate constant.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of CL/f.||||||
2632687|NCT01832506|Secondary|Area Under the Concentration Time Curve From Time Zero to Extrapolated Infinite Time (AUC[Inf]) of MSC2156119J|AUC(inf) was calculated by combining AUC0-t and AUCextra. AUCextra represented an extrapolated value obtained by Clast/λz, where Clast was the calculated plasma concentration at the last sampling time point at which the measured plasma concentration was at or above the LLQ and λz is the terminal elimination rate constant.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of AUCinf.||||||
2632688|NCT01832506|Secondary|Apparent Terminal Half-life (t1/2) of MSC2156119J|Terminal half-life is the time measured for the plasma concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base 2 (Ln2) divided by elimination rate constant (λz), where 'λz' is calculated by a linear regression of the log-linear concentration-time curve.|pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1 and Day 14 Cycle 1|It was not possible to calculate data for this outcome measure because dosing interval was too small compared to the long half-life to characterize the terminal phase rate constant, which is needed for the calculation of t1/2.||||||
2632689|NCT01832506|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) After Multiple Dose of MSC2156119J||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome at the specified time point for each arm, respectively.|||hours||Full Range|Median
2632690|NCT01832506|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) After Single Dose of MSC2156119J||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|PK analysis set included all subjects who had completed Cycle 1 without any relevant protocol violations with respect to factors that were likely to affect the PK results and who received at least first dose of study drug according to the protocol providing sufficient concentration time data to determine the PK endpoints for the study drug.|||hours||Full Range|Median
2632691|NCT01832506|Secondary|Maximum Plasma Concentration (Cmax) After Multiple Dose of MSC2156119J||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 14 Cycle 1|PK analysis set. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome at the specified time point for each arm, respectively.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2632692|NCT01832506|Secondary|Maximum Plasma Concentration (Cmax) After Single Dose of MSC2156119J||pre-dose, 0.25, 0.5, 1, 2, 4, 8, 10, 24 hours post-dose on Day 1 Cycle 1|Pharmacokinetic (PK) analysis set included all subjects who had completed Cycle 1 without any relevant protocol violations with respect to factors that were likely to affect PK results and who received at least first dose of study drug according to protocol providing sufficient concentration time data to determine PK endpoints for the study drug.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2632693|NCT01832506|Secondary|Number of Subjects With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score of 2 or Higher|ECOG PS score is widely used by doctors and researchers to assess how a subjects' disease is progressing, and is used to assess how the disease affects the daily living abilities of the subject, and determine appropriate treatment and prognosis. The score ranges from Grade 0 to Grade 4, where Grade 0 = Fully active, able to carry on all pre-disease performance without restriction, Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (like light house work, office work), Grade 2 = Ambulatory and capable of all self-care but unable to carry out any work activities, Grade 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours and Grade 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.|Baseline up to 30 days after last dose of study drug administration (55.1 weeks)|Safety analysis set included all subjects who had received at least 1 dose of the IMP.|||subjects|||Number
2633166|NCT01828554|Secondary|Response Rate|Responses will be determined using RECIST v. 1.1 criteria and summarized in tabular format. The complete and partial response rates will be calculated and reported along with the corresponding 95% confidence intervals.|Up to 6 months||||percentage||95% Confidence Interval|Number
2632694|NCT01832506|Secondary|Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs or TEAEs Leading To Death|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline Up to 30 days after last dose of study drug administration (55.1 weeks)|Safety analysis set included all subjects who had received at least 1 dose of the IMP.|||subjects|||Number
2632695|NCT01832506|Primary|Number of Subjects Experiencing Dose Limiting Toxicity (DLT)|DLT: defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.0, as any of following toxicities: Grade 4 neutropenia for more than 7 days; greater than or equal to (>=) Grade 3 febrile neutropenia; Grade 4 or Grade 3 thrombocytopenia with bleeding; >=Grade 3 nausea despite adequate treatment; >=Grade 3 any non-hematological AE (DLT defined specifically for following cases: >=Grade 3 liver adverse event [AE] requiring recovery period of more than 7 days or to Grade 1 without liver metastases or Grade 2 with liver metastases ; >=Grade 3 lipase and/or amylase elevation with confirmation of pancreatitis. An isolated lipase and/or amylase elevation of >=Grade 3 without clinical/radiological evidence of pancreatitis was not classified as DLT); and >=Grade 2 any AE not otherwise defined as DLT that, due to prolonged recovery to Grade 1 (or less) or baseline status, led to delay of treatment with IMP for more than 21 days.|Cycle 1 (Day 1 up to 21)|DLT analysis set included all subjects who completed Cycle 1 (having received 80% or more of planned cumulative dose of IMP for Cycle 1) or who stopped treatment with IMP during Cycle 1 because of DLT.|||subjects|||Number
2632696|NCT01832493|Primary|Optimal Electrode Configuration Determination Using Heart Sounds|Current practices use the measurement LV dP/dt max to determine how the optimal electrode configuration for a CRT device. Heart sounds, as measured by S1 Amplitude, is another method that could be used to determine the optimal electrode configuration. This outcome measure is the number of patients where the optimal electrode configuration setting as determined by heart sounds agrees with the optimal setting determined by LV dP/dt max|During implant|Patients with a RV tripolar S1 amplitude measurement and a LV dP/dT max measurement for all electrode configurations of interest.|||participants|||Number
2632697|NCT01832493|Primary|Optimal Electrode Configuration Determination Using Impedance|Current practices use the measurement LV dP/dt max to determine how the optimal electrode configuration for a CRT device. Intracardiac impedance is another method that could be used to determine the optimal electrode configuration. This outcome measure is the number of patients where the optimal electrode configuration setting as determined by intracardiac impedance agrees with the optimal setting determined by LV dP/dt max|During implant|Patients with a RV tripolar intracardiac impedance measurement and a LV dP/dT max measurement for all electrode configurations of interest.|||participants|||Number
2632698|NCT01832493|Primary|AV Interval Determination Using Heart Sounds|Current practices use the measurement LV dP/dt max to determine how the AV interval should be programmed in a CRT device. A heart sounds measure, called S1 Amplitude Transition, is another method that could be used to determine the optimal AV interval. This outcome measure is the number of patients where the optimal AV interval setting as determined by heart sounds agrees within one AV interval setting (30 milliseconds) of the optimal setting determined by LV dP/dt max|During implant|Patients with a RV tripolar S1 Amplitude Transition measurement and a LV dP/dT max measurement for all AV intervals of interest.|||participants|||Number
2632699|NCT01832493|Primary|AV Interval Determination Using Impedance|Current practices use the measurement LV dP/dt max to determine how the AV interval should be programmed in a CRT device. Intracardiac impedance is another method that could be used to determine the optimal AV interval. This outcome measure is the number of patients where the optimal AV interval setting as determined by intracardiac impedance agrees within one AV interval setting (30 milliseconds) of the optimal setting determined by LV dP/dt max.|During implant|Patients with a RV tripolar intracardiac impedance measurement and a LV dP/dT max measurement for all AV intervals of interest.|||participants|||Number
2632700|NCT01832480|Primary|Number of Subjects That Were Trichomonas Vaginalis (TV) Positive After Treatment With Metronidazole (MTZ)|Presence of TV is assessed by nucleic acid amplification test (NAAT) of vaginal swab collected 4 weeks post treatment completion.|4 weeks post treatment completion|570 cases available. Multiple imputation performed for those with missing Test of Cure (TOC) data.|||Participants|||Count of Participants
2632701|NCT01832259|Secondary|Biochemical Recurrence Progression Free Survival Rate|Following prostatectomy, patients' Prostate Specific Antigen (PSA) lab values were collected for up to two years. Biochemical recurrence was defined as the first PSA lab value of greater than or equal to 0.2 ng/mL following prostatectomy. Biochemical recurrence progression free survival rate was defined as the percent chance of 1 year survival with no biochemical recurrence.|2 years|Two patients on the Pazopanib arm were not evaluable, one due to prostatectomy not being completed, and one due to prostatectomy being delayed outside of protocol windows.|||percent chance of survival||95% Confidence Interval|Number
2632702|NCT01832259|Secondary|Participants Experiencing Adverse Events|Adverse events were assessed using the Common Terminology for Adverse Events (CTCAE) version 4. Each event was assigned a grade (1-5), with lower grades indicating milder events. All adverse events were recorded, regardless of attribution to study treatment. For a full listing of Adverse Events, please see the Adverse Events section of the Results for this study.|From first dose of study treatment to one month post-prostatectomy (approximately 2 months)||||Participants|||Count of Participants
2632737|NCT01831921|Secondary|Diastolic Blood Pressure|Mean diastolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.|6, 12, 18, and 24 months|Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected.|||mmHg||Standard Deviation|Mean
2632703|NCT01832259|Primary|Number of Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Positive Clusters|Patients with high-risk, localized prostate cancer were treated with 28 days of Pazopanib or placebo, after which they underwent radical prostatectomy. During prostatectomy, benign pelvic lymph node tissue was collected and subsequently analyzed for the average number of VEGFR1-positive clusters in 8 distinct 40x microscopic fields as an indicator of pre-metastatic niche formation.|1 month|The tissue of one patient on the Pazopanib arm and two patients on the Placebo arm was not able to be analyzed. Another patient on the Pazopanib arm had surgery delayed by a few weeks following stopping study medication and was determined to be unevaluable, resulting in 13 patients analyzed on each arm.|||VEGFR1+ clusters per hpf||Standard Deviation|Mean
2632704|NCT01832155|Other Pre-specified|Feasibility Measure - Recruitment|The number of months it took to recruit 36 participants.|9 months||||months|||Number
2632705|NCT01832155|Primary|Absolute Value of OA Pain at 8 Weeks|A single question that asked about the number of pain medications used per day for knee OA was also used to measure OA pain status.|8 weeks||||Number of pain medication/day||Standard Error|Mean
2632706|NCT01832155|Other Pre-specified|Feasibility Measure - Safety|Safety was assessed by measuring the frequency of yoga related injuries that occur from group or home-based exercise sessions during the active treatment periods.|8 weeks||||injuries|||Number
2632707|NCT01832155|Other Pre-specified|Feasibility Measure - Acceptability|"Acceptability was evaluated by the participants' perceived difficulty of the yoga class and level of enjoyment. Upon completion of the yoga program, perceived level of program difficulty was rated by participants using a scale of 1 - 10 where 10 represents extremely difficult and a scale of 1 - 10 where 10 represents most enjoyable was used to measure perceived level of program enjoyment. Data from both intervention and wait-list control (during the intervention period) groups were collected."|8 weeks||||units on a scale||Full Range|Mean
2632708|NCT01832155|Other Pre-specified|Feasibility Measures - Adherence|Feasibility was also measured by the home practice adherence rate during the 8 weeks program. Data from both intervention and wait-list control (during their treatment period) groups were collected. Home yoga practice adherence was determined by participants' report of the average number of minutes of yoga practiced at home.|8 Weeks||||minutes/week||Full Range|Mean
2632709|NCT01832155|Other Pre-specified|Feasibility Measures - Retention|Feasibility was measured by the retention rate during the 8 weeks program. Data from both intervention and wait-list control (during their treatment period) groups were collected. Participants' class attendance (average number of classes attended) was evaluated.|8 weeks||||classes||Full Range|Mean
2632710|NCT01832155|Secondary|Absolute Value of BMI at 8 Weeks|BMI was calculated using the participant's weight and height, kg/m^2.|8 weeks||||kg/m^2||Standard Error|Mean
2632711|NCT01832155|Secondary|Absolute Value of Quality of Life at 8 Weeks|"The self-perceived quality of life was assessed using the Short Form Health Survey (SF-12) which measures a total of 8 health domains: 4 physical and 4 mental component summary scales. Physical Health (physical functioning, role-physical, bodily pain, and general health)and Mental Health (vitality, social functioning, role-emotional, and mental health) Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. The Cantril Self-Anchoring Ladder that measures both current and in 5 years using steps from 0 to 10, where 0 represents the worst possible life and 10 represents the best possible life."|8 weeks||||units on a scale||Standard Error|Mean
2632712|NCT01832155|Secondary|Absolute Value of Quality of Sleep at 8 Weeks|Pittsburgh Sleep Quality Index (PSQI) was used to measure quality of sleep. The PSQI is a 19-item self-rated questionnaire for evaluating subjective sleep quality over the previous month. The 19 questions are combined into 7 clinically-derived component scores, each weighted equally from 0-3 whereby 3 reflects the negative extreme on the Likert Scale. The 7 component scores are added to obtain a global score ranging from 0-21, with higher scores indicating worse sleep quality. A global score of ≥ 5 on the PSQI total scale, which is computed as a sum of the seven subscales (e.g., sleep quality, sleep latency, sleep duration, sleep disturbance, sleep efficiency, and use sleep medication) is associated with clinically significant sleep disruptions, including insomnia and major mood disorders.|8 weeks||||units on a scale||Standard Error|Mean
2632713|NCT01832155|Secondary|Absolute Value of Physical Performance of the Lower Extremities (LE) at 8 Weeks|"Secondary outcome measures included physical performance of the LE which was assessed using the Short Physical Performance Battery (SPPB) developed by the National Institute on Aging. The test consists of three components: repeated chair stands (4 points), balance (4 points), and timed 8 walk (4 points). A maximum score of 12 points can be achieved. Higher values indicate better physical functions."|8 weeks||||units on a scale||Standard Error|Mean
2632714|NCT01832155|Primary|Absolute Value of OA Symptoms at 8 Weeks|Primary outcome measures included: OA symptoms (pain, stiffness and function) were assessed using the Western Ontario and McMaster Universities OA Index scale (LK scale 3.1)(WOMAC). The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales resulting in a possible score of 0 - 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|8 weeks||||units on a scale||Standard Error|Mean
2632715|NCT01832090|Secondary|Global Aesthetic Improvement Scale (GAIS) Ratings, by Subject, Among All Treated Subjects With and Without Retreatment|To evaluate the efficacy of Radiesse for hand treatment as measured by live, subject-completed Global Aesthetic Improvement Scale (GAIS) scores between baseline and 3, 6, 9, and 12 months, by subject, among treated subjects with and without retreatment|3, 6, 9, and 12 months from baseline|Single withdrawn subject did not receive treatment and is not included in this analysis.|||percentage of participants|Hands||Number
2632738|NCT01831921|Secondary|Systolic Blood Pressure|Mean systolic blood pressure in both treatment groups at 6, 12, 18, and 24 months will be assessed.|6, 12, 18, and 24 months|Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected.|||mmHg||Standard Deviation|Mean
2633391|NCT01825876|Secondary|PK: Cmax of R-Warfarin||Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose|All participants who received a dose of study drug and had evaluable data for Cmax.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2632716|NCT01832090|Secondary|≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Subject, Among All Treated Subjects With and Without Retreatment|"To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9, and 12 months, by subject, among treated subjects with and without retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3, 6, 9, and 12 months from baseline|Single withdrawn subject did not receive treatment and is not included in this analysis.|||percentage of participants|||Number
2632717|NCT01832090|Secondary|≥ 1-point Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With and Without Retreatment|"To evaluate the efficacy of Radiesse for hand treatment as measured by ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9 and 12 months, by hand, among treated subjects with and without retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3, 6, 9, and 12 months from baseline|Single withdrawn subject did not receive treatment and is not included in this analysis.|||% hands with ≥ 1 point MHGS change|Hands||Number
2632718|NCT01832090|Secondary|Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects With Retreatment|"To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects receiving retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3, 6, 9, and 12 months from baseline|Single withdrawn subject did not receive treatment and is not included in this analysis.|||units on a scale|Hands|Standard Deviation|Mean
2632719|NCT01832090|Secondary|Mean Change on the Merz Hand Grading Scale (MHGS), by Hand, Among All Treated Subjects Without Retreatment|"To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3, 6, 9, and 12 months, by hand, among all treated subjects without retreatment. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3, 6, 9, and 12 months from baseline|Single withdrawn subject did not receive treatment and is not included in this analysis.|||units on a scale|Hands|Standard Deviation|Mean
2632720|NCT01832090|Secondary|Global Aesthetic Improvement Scale (GAIS) Ratings Among the Original Treatment Group Only|To evaluate the efficacy of Radiesse for hand treatment by evaluating subject-reported, live Global Aesthetic Improvement Scale (GAIS) ratings at 3 months when compared to baseline among the original treatment group only|3 months from baseline|"Single withdrawn subject imputed as no change"|||percentage of participants|Hands||Number
2632721|NCT01832090|Secondary|Evenness in the Left Hand Versus the Right Hand Using the Merz Hand Grading Scale (MHGS) Among the Original Treatment Group Only|"To evaluate the efficacy of Radiesse for hand treatment by comparing the evenness in the left hand versus the right hand at 3 months using the 5-point Merz Hand Grading Scale (MHGS) among the original treatment group only. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|"Single withdrawn subject imputed as no change"|||percentage of participants|||Number
2632722|NCT01832090|Secondary|≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Subject, With Subjects Stratified by Age < 60 Years or ≥ 60 Years|"To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by subject, among treated subjects and untreated controls, stratified by age < 60 years or ≥ 60 years. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|"Single withdrawn subject imputed as no change"|||percentage of participants|||Number
2632723|NCT01832090|Secondary|≥ 1-point Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years|"To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by hand, among treated subjects and untreated controls, stratified by age < 60 years or ≥ 60 years. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|"Single withdrawn subject imputed as no change"|||percentage of hands|Hand||Number
2633167|NCT01828554|Primary|Cmax During Cycle 1|Cmax will be reported for Capecitabine dosed for Ideal Body Weight during the first cycle (days 1-7) and for Capecitabine dosed for Actual Body Weight for first cycle (days 9-15). [nonlinear mixed effects modeling approach]|Up to 15 days||||Cmax (ug/ml)||Standard Deviation|Mean
2632724|NCT01832090|Secondary|Mean Change on Merz Hand Grading Scale (MHGS), by Hand, With Subjects Stratified by Age < 60 Years or ≥ 60 Years|"To evaluate the efficacy of Radiesse for hand treatment as measured by mean change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by hand, among treated subjects and untreated controls, stratified by age < 60 years or ≥ 60 years. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|"Single withdrawn subject imputed as no change"|||units on a scale|Hands|Standard Deviation|Mean
2632725|NCT01832090|Primary|≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Subject|"To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by subject, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|All primary effectiveness analyses were performed based on the intent-to-treat (ITT) population. This population includes all subjects randomized. One subject was randomized but did not receive treatment and was imputed as “No change” for the primary endpoint.|||percentage of participants|||Number
2632726|NCT01832090|Primary|≥ 1-point Change on the 5-point Merz Hand Grading Scale (MHGS), by Hand|"To evaluate the efficacy of Radiesse for hand treatment as measured by a ≥ 1-point change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by hand, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|All primary effectiveness analyses were performed based on the intent-to-treat (ITT) population. This population includes all subjects randomized. One subject was randomized but did not receive treatment and was imputed as “No change” for the primary endpoint.|||percentage of hands|Hands||Number
2632727|NCT01832090|Primary|Mean Change on Merz Hand Grading Scale (MHGS), by Hand|"To evaluate the efficacy of Radiesse for hand treatment as measured by a mean change on the 5-point Merz Hand Grading Scale (MHGS) between baseline and 3 months, by hand, among treated subjects and untreated controls. A measure of successful or improved treatment effect is demonstrated by a decrease in MHGS score.~MHGS categories are as follows:~0 = no loss of fatty tissue;~1 = mild loss of fatty tissue; slight visibility of veins; 3 = moderate loss of fatty tissue; mild visibility of veins and tendons; 4 = severe loss of fatty tissue; moderate visibility of veins and tendons; and 5 = very severe loss of fatty tissue; marked visibility of veins and tendons."|3 months from baseline|All primary effectiveness analyses were performed based on the intent-to-treat (ITT) population. This population includes all subjects randomized. One subject was randomized but did not receive treatment and was imputed as “No change” for the primary endpoint.|||units on a scale|Hands|Standard Deviation|Mean
2632728|NCT01831934|Other Pre-specified|Measurement of Intracellular Glutathione by Hi-D FACS (CD4 and CD8 T Cells) and Tandem Mass Spectrometry (Whole Blood)|This method relies on the ability of intracellular glutathione S-transferases to tag GSH to bimane to yield a bimane-GS conjugate that fluoresces at 440 nm.|Day 0-Day28|||||||
2632729|NCT01831934|Primary|Clinical Safety of TIV Vaccine|We will measure solicited local and systemic adverse events and SAEs for 1 month following immunization|Day 0 to Day28||||Participants|||Count of Participants
2632730|NCT01831921|Other Pre-specified|Homeostasis Model of Insulin Resistance (HOMA IR)|Mean change in the HOMA IR model from baseline between treatment groups at 6, 12, and 24 months will be assessed.|6, 12, and 24 months|||||||
2632731|NCT01831921|Other Pre-specified|Fasting Insulin|Mean change in fasting insulin from baseline between treatment groups at 6, 12, and 24 months will be assessed.|6, 12, and 24 months|||||||
2632732|NCT01831921|Secondary|Triglycerides|Mean triglycerides in both treatment groups at 12 and 24 months will be calculated.|12, and 24 months|Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 24 month data was collected.|||mg/dL||Standard Deviation|Mean
2632733|NCT01831921|Secondary|Low Density Lipoprotein (LDL)|Mean LDL in both treatment groups at 12 and 24 months will be calculated.|12, and 24 months|Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 24 month data was collected.|||mg/dL||Standard Deviation|Mean
2632734|NCT01831921|Secondary|High Density Lipoprotein (HDL)|Mean HDL in both treatment groups at 12 and 24 months will be assessed.|12, and 24 months|Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 24 month data was collected.|||mg/dL||Standard Deviation|Mean
2632735|NCT01831921|Secondary|Total Cholesterol|Mean total cholesterol in both treatment groups at 12 and 24 months will be assessed.|12, and 24 months|Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 24 month data was collected.|||mg/dL||Standard Deviation|Mean
2632736|NCT01831921|Secondary|Fasting Glucose|Mean fasting plasma glucose in both treatment groups at 6, 12, 18, and 24 months will be assessed.|6, 12, 18, and 24 months|Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected.|||mg/dL||Standard Deviation|Mean
2632739|NCT01831921|Secondary|Body Weight|Mean body weight in both treatment groups at 6, 12, 18, and 24 months will be assessed.|6, 12, 18, and 24 months|Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected.|||kilograms||Standard Deviation|Mean
2632740|NCT01831921|Primary|Hemoglobin A1c|Mean hemoglobin A1c in both treatment groups at 6, 12, 18, and 24 months will be assessed.|6, 12, 18, and 24 months|Participant retention at clinic assessment visits is presented below as the number analyzed at each time-point. Follow-up on all participants was at least 12 months; for those participants randomized early in the recruitment process, 18 and 24 month data was collected.|||percent HbA1c||Standard Deviation|Mean
2632741|NCT01831856|Primary|Time to First Atrial Fibrillation (AF) Recurrence or Atrial Flutter Emergence Defined by the Time to First Episode of AF or Atrial Flutter Lasting for at Least 10 Minutes During the 20-week Follow-up After Visit 3 (Electrical Cardioversion (ECV) Visit).|Time to first Atrial Fibrillation (AF) recurrence defined by the first episode of Atrial Fibrillation lasting for at least 10 minutes. AF recurrences or atrial flutter emergences: 7-day continuous electrocardiogram (ECG; 5-leads/2 or 3 channels) ambulatory recording (Holter ECG) between Visit 3 (Electrical Cardioversion Visit) and Visit 4 (Week 5). Then, the follow-up was documented using the Transtelephonic ECG monitor (TTEM): one transmission every two days from Week 9 to Week 24. For randomised patients with spontaneous cardioversion before Electrical Cardioversion, the recurrence of AF or the emergence of atrial flutter was assessed after Visit 3 (from Week 5). Moreover, during this TTEM period, if the patient experienced any AF or atrial flutter symptoms, it was recorded and documented using the TTEM.|from electrical cardioversion (Visit 3) to last follow-up visit (W24)|The Full Analysis Set is composed of all randomised patients having received at least one dose of the study treatment and with a successful cardioversion observed at Visit 3; a successful cardioversion was defined as either spontaneous cardioversion before Visit 3 or successful Electrical Cardioversion performed at Visit 3.|||days||95% Confidence Interval|Median
2632742|NCT01831817|Secondary|Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire (DHEQ) Total Score at Week 8|DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life.|Baseline and 8 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.|||Score on a scale||Standard Deviation|Mean
2632743|NCT01831817|Secondary|Mean Change From Baseline in Dentine Hypersensitivity Experience Questionnaire Total Score at Week 4|DHEQ Total score is an overall summary measure for the impact of dentine hypersensitivity on everyday life. Total score is calculated as the sum of 34 questions (each with a possible score of 1 to 7). The scale of responses range from 34 to 238. Higher values imply a worse outcome i.e. an increase in impact on dentine hypersensitivity on everyday life. Lower values imply a better outcome i.e. a decrease in impact on dentine hypersensitivity on everyday life.|Baseline and 4 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.|||Score on a scale||Standard Deviation|Mean
2632744|NCT01831817|Primary|Mean Change From Baseline in Visual Rating Scale Score at Week 8|"The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes No Pain and 10 denotes Intense Pain."|Baseline and 8 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.|||Score on a scale||Standard Deviation|Mean
2632745|NCT01831817|Primary|Mean Change From Baseline in Visual Rating Scale Score at Week 4|"The intensity of response to stimulus will be rated using a 10 point scale where 1 denotes No Pain and 10 denotes Intense Pain."|Baseline and 4 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.|||Score on a scale||Standard Deviation|Mean
2632746|NCT01831817|Primary|Median Change From Baseline in Tactile Sensitivity at Week 8|Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline and 8 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.|||grams||Full Range|Median
2632747|NCT01831817|Primary|Median Change From Baseline in Tactile Sensitivity at Week 4|Response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the subject whether the sensation caused discomfort. The pressure setting at which the subject gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.|Baseline and 4 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.|||grams||Full Range|Median
2632847|NCT01831258|Secondary|OSA Impact of Daily Life (Fatigue)|Collected through the Fatigue Severity Scale (FSS). There are 9 question on fatigue with each question having a scale of 1 = strongly disagree and 7 = strongly agree. A lower total score (minimum of 9) = low severity with fatigue while a higher total score (maximum of 63) indicates a higher severity with fatigue.|4 weeks|Data for 64 participant were available|||units on a scale||Standard Error|Mean
2632748|NCT01831817|Primary|Mean Change From Baseline in Schiff Sensitivity Score at Week 8|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.|Baseline and 8 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.|||Score on a Scale||Standard Deviation|Mean
2632749|NCT01831817|Primary|Mean Change From Baseline in Schiff Sensitivity Score at Week 4|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant did not respond to air stimulation, 1 - participant responded to air stimulus but did not request discontinuation of stimulus, 2 - participant responded to air stimulus and requested discontinuation of stimulus, 3 - participant responded to air stimulus, considered stimulus to be painful and request discontinuation of stimulus.|Baseline and 4 weeks post administration of study treatment|The ITT population was defined as all participants who were randomized, administered at least one study treatment during the study and had at least one post baseline assessment of efficacy.|||Score on a scale||Standard Deviation|Mean
2632750|NCT01831804|Primary|AUC(0-t) of GSK1278863 (Part B)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. AUC (0-t) could not be determined as data was below the limit of quantification.|Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14|PK Population|||hour*nanograms/milliliter||Standard Deviation|Mean
2632751|NCT01831804|Primary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments [AUC(0-t)] of GSK1278863 (Part A)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. AUC (0-t) could not be determined as data was below the limit of quantification.|Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hrs post-dose|PK Population|||hour*nanograms/milliliter||Standard Deviation|Mean
2632752|NCT01831804|Primary|AUC(0-inf) of GSK1278863 (Part B)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. AUC (0-inf) could not be determined as data was below the limit of quantification.|Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14|PK Population|||hour*nanograms/milliliter||Standard Deviation|Mean
2632753|NCT01831804|Primary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC(0-inf)] of GSK1278863 (Part A)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. AUC (0-inf) could not be determined as data was below the limit of quantification.|Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72hrs post-dose|PK Population|||hour*nanograms/milliliter||Standard Deviation|Mean
2632754|NCT01831804|Primary|Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) (Part B)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Tlag could not be determined as data was below the limit of quantification.|Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14|PK Population|||Hour||Standard Deviation|Mean
2632755|NCT01831804|Primary|Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) (Part A)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Tlag could not be determined as data was below the limit of quantification.|Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72hrs post-dose|PK Population|||Hour||Standard Deviation|Mean
2632756|NCT01831804|Primary|t1/2 of GSK1278863 (Part B)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. t1/2 could not be determined as data was below the limit of quantification.|Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14|PK Population|||Hour||Standard Deviation|Mean
2632757|NCT01831804|Primary|Apparent Terminal Elimination Half-life (t1/2) of GSK1278863 (Part A)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. t1/2 could not be determined as data was below the limit of quantification.|Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72hrs post-dose|PK Population|||Hour||Standard Deviation|Mean
2632758|NCT01831804|Primary|Tmax of GSK1278863 (Part B)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Tmax could not be determined as data was below the limit of quantification.|Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14|PK Population|||Hour||Standard Deviation|Mean
2632759|NCT01831804|Primary|Time of Occurrence of Cmax (Tmax) of GSK1278863 (Part A)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Tmax could not be determined as data was below the limit of quantification.|Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72hrs post-dose|PK population|||Hour||Standard Deviation|Mean
2632760|NCT01831804|Primary|Cmax of GSK1278863 (Part B)|The pharmacokinetic parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Cmax could not be determined as data was below the limit of quantification.|Pre-dose and 2 hrs on Day 1 and 7; pre-dose, 1, 2,4, 8, 12 and 24 hrs post-dose on Day 14|PK Population|||ng/mL||Standard Deviation|Mean
2632761|NCT01831804|Primary|Maximum Observed Concentration (Cmax) of GSK1278863 (Part A)|The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis according to current working practices and using WinNonlin Version 5.2 or higher. All calculations of non-compartmental parameters were based on actual sampling times. Cmax could not be determined as data was below the limit of quantification.|Pre-dose and 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hrs post-dose|All participants from whom a PK sample had been obtained and analyzed were included in the PK Population|||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2632762|NCT01831804|Primary|Number of Participants With Clinical Chemistry Values Outside the Clinical Concern Range (Part B)|Chemistry parameters assessed were: Blood urea nitrogen (BUN), creatinine, fasting glucose, sodium, creatine phosphokinase (CPK), potassium, chloride, total carbon dioxide (CO2), calcium, glycosylated hemoglobin (HbA1C), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Gamma glutamyltransferase (GGT), Alkaline phosphatase (ALP), High sensitivity C-reactive protein (hsCRP), total and direct bilirubin, uric acid, albumin and total protein. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). When a high or low value was reported, all values are presented for that time point and parameter.|Days 1 and 7 (pre-dose) and Day 14 (24 hours)|All Subjects Population|||Participants|||Number
2632763|NCT01831804|Primary|Number of Participants With Clinical Chemistry Values Outside the Clinical Concern Range (Part A)|Chemistry parameters assessed were: Blood urea nitrogen (BUN), creatinine, fasting glucose, sodium, creatine phosphokinase (CPK), potassium, chloride, total carbon dioxide (CO2), calcium, glycosylated hemoglobin (HbA1C), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Gamma glutamyltransferase (GGT), Alkaline phosphatase (ALP), High sensitivity C-reactive protein (hsCRP), total and direct bilirubin, uric acid, albumin and total protein. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). When a high or low value was reported, all values are presented for that time point and parameter.|Day 1 (pre-dose and 48 hours) in period 1; Day 1 (48 hours) in period 2|All Subjects Population|||Participants|||Number
2632764|NCT01831804|Primary|Number of Participants With Hematology Data Outside the Clinical Concern Range (Part B)|Hematology parameters assessed were: platelet count, red blood cell count, white blood cell count, hemoglobin, reticulocyte count, hematocrit, neutrophils, monocytes, lymphocytes, eosinophils, basophils, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration. When a high or low value was reported, all values are presented for that time point and parameter.|Day 1 (pre-dose)|All Subjects Population|||Participants|||Number
2632765|NCT01831804|Primary|Number of Participants With Hematology Values Outside the Clinical Concern Range (Part A)|Hematology parameters assessed were: platelet count, red blood cell count, white blood cell count, hemoglobin, reticulocyte count, hematocrit, absolute neutrophil count (ANC), monocytes, lymphocytes, eosinophils, basophils, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration. When a high or low value was reported, all values are presented for that time point and parameter.|Day 1 (pre-dose)|All Subjects Population|||Participants|||Number
2632766|NCT01831804|Primary|Number of Participants With Abnormal Nurse/Physician Observation (Part B)|A brief physical assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen) were planned to be performed by qualified licensed, medical professional (i.e., physician, physician assistant, or nurse practitioner) but was not performed. Since data was not collected, no analysis was performed.|Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose])|All Subject Population||||||
2632767|NCT01831804|Primary|Number of Participants With Abnormal Nurse/Physician Observation (Part A)|A brief physical assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen) were planned to be performed by qualified licensed, medical professional (i.e., physician, physician assistant, or nurse practitioner) but was not performed.Since data was not collected, no analysis was performed.|Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose])|All Subject Population||||||
2632768|NCT01831804|Primary|Number of Participants With Vital Sign Data Outside Clinical Concern Range Following Repeat Dose Administration (Part B)|Vital sign measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Vital signs were measured after the participants rested in a supine or semi-supine position for 5 minutes prior to the procedure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). When a high or low value was reported, all values are presented for that time point and parameter.|Days 1 and 7 (pre-dose), Day 14 (24 hours)|All Subject Population|||Participants|||Number
2632769|NCT01831804|Primary|Number of Participants With Vital Sign Data Outside Clinical Concern Range Following Single Dose Administration (Part A)|Vital sign measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Vital signs were measured after the participants rested in a supine or semi-supine position for 5 minutes prior to the procedure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). When a high or low value was reported, all values are presented for that time point and parameter.|Day 1 (pre-dose and 48 hours) of Periods 1 and 2|All Subject Population|||Participants|||Number
2632770|NCT01831804|Primary|Number of Participants With Clinically Significant 12-lead ECG Measurement Following Repeat Dose Administrations (Part B)|ECG measurements were taken with the participants in supine position for at least 5 minutes. The number of participants with clinically significant abnormal ECG measurement following single dose administration for worst case post-Baseline visit has been presented.|Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose])|All Subject Population|||Participants|||Number
2633168|NCT01828554|Primary|Area Under the Curve (AUC) on Cycle 1 Day 1 and Cycle 1 Day 9|AUC will be calculated for Capecitabine dosed for Ideal Body Weight during the first cycle (days 1-7) and for Capecitabine dosed for Actual Body Weight for first cycle (days 9-15). [nonlinear mixed effects modeling approach]|Up to 15 days||||AUC (ug/ml)*h||Standard Deviation|Mean
2632771|NCT01831804|Primary|Number of Participants With Clinically Significant 12-lead Electrocardiograms (ECGs) Measurement Following Single Dose Administrations (Part A)|ECG measurements were taken with the participants in supine position for at least 5 minutes. The number of participants with clinically significant abnormal ECG measurement following single dose administration for worst case post-Baseline visit has been presented.|Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose])|All Subject Population|||Participants|||Number
2632772|NCT01831804|Primary|Number of Participants With AEs and SAEs Following Repeat Dose Administration (Part B)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events; or is associated with liver injury and impaired liver function.|Up to a maximum of 53 days (Start of study treatment through final follow up 2 [28-32 days post last dose])|All Subject Population.|||Participants|||Number
2632773|NCT01831804|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Single Dose Administration (Part A)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events; or is associated with liver injury and impaired liver function.|Up to a maximum of 75 days (Start of study treatment through final follow up 2 [28-32 days post last dose])|All Subject Population comprised of all participants who received at least one dose of study drug (including GSK1278863, placebo and standard care).|||Participants|||Number
2632774|NCT01831791|Secondary|Serum Concentrations of Dihydrotestosterone (DHT) at Baseline, and After 26 Weeks and 52 Weeks|Blood samples for DHT analysis was collected at Baseline, Week 26 and Week 52. DHT values at a lower limit of quantification (LLQ) were imputed using 1/2 LLQ. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing visit data and/or for participants who discontinued from the study.|Baseline, Week 26 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|||nanomole per liter (nmol/L)||Standard Deviation|Mean
2632775|NCT01831791|Secondary|Change From Baseline in Quality of Life as Assessed by Dermatology Life Quality Index (DLQI) at Week 13, Week 26, Week 39, and Week 52|The DLQI is a 10-item validated measure developed specifically to assess quality of life (QoL) in participants with dermatological conditions. It assesses six domains: symptoms and feelings, daily activities, leisure, work ⁄school, personal relationships, and treatment. The DLQI total is the sum of 10 questions, each ranging from 0 (unanswered/not relevant,not at all) to 3 (very much). The higher the score, the greater the impairment of (QoL). Change from Baseline in DLQI scores is defined as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 13, Week 26, Week 39, and Week 52|ITT Population|||Scores on a scale||Standard Deviation|Mean
2632776|NCT01831791|Secondary|Change From Baseline in Sexual Problems as Assessed by the Problem Assessment Scale of the Sexual Function Inventory (PAS SFI) at Week 13, Week 26, Week 39, and Week 52|The Problem Assessment Scale of the Sexual Function Inventory (PAS SFI) questionnaire was used to assess participant-perceived problems in sexual function using 3 questions assessing problems with sex drive, erections and ejaculation. They are scored on a 5-point scale of 0 to 4 (0=big problem, 1= medium problem, 2=small problem, 3=very small problem, 4=no problem). Total scores range from 0-12. Change from Baseline in PAS SFI scores is defined as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 13, Week 26, Week 39 and Week 52|ITT Population|||Scores on a scale||Standard Deviation|Mean
2632777|NCT01831791|Secondary|Number of Participants With the Indicated Change From Baseline (BL) in the Stage of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at 26 Weeks and 52 Weeks|"The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness [MPB]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than Stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Screening (Baseline), Week 26, and Week 52. v, vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. a, type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex. The number of participants with stage changes from Baseline are summarized. The LOCF method for missing data was used by carrying forward the last non-missing post-Baseline assessment for participants with missing data and/or for participants who discontinued from the study."|Baseline, Week 26 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|||Participants|||Number
2632873|NCT01831089|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from the date of first infusion of study treatment to the date of progression or death (due to any cause). If progression or death had not occurred at the time of the analysis, the PFS was censored.|Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks)||||months||95% Confidence Interval|Median
2632778|NCT01831791|Secondary|Mean of Median Score for Panel Global Assessment of Improvement From Baseline to 26 Weeks and 52 Weeks for Vertex and Frontal Views|A central panel of 3 dermatologists independently assessed change in hair growth from Baseline to Week 26 and Week 52 using a 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3). The median score, across the 3 panel members, is summarized. This assessment was performed by comparing the global photographs obtained at Baseline (Screening) with those subsequently obtained at Week 26 and Week 52. This assessment was made separately based on the global photography of the vertex and frontal views. The LOCF method for missing data was used for the assessment, if a participants was missing the Week 26 global photograph, but has a global photograph from an earlier assessment (i.e., a withdrawal visit), then that photograph was assessed during the panel review.|Baseline, Week 26 and Week 52|ITT Population. Only participants avilable at the specified time were analysed.|||Scores on a scale||Standard Deviation|Mean
2632779|NCT01831791|Secondary|Mean Change From Baseline (BL) in Terminal Hair Count Within a 2.54 cm Diameter Circle at Week 26 and Week 52|Terminal hair count was based on the terminal hair(>=60 μm in width) count within a target 2.54cm(1 inch) diameter circle at the vertex and was assessed by macrophotographic technique. A cosmetic ink dot was placed by means of a tattoo at BL on the scalp in the center of the circle as a marker to guide the placement of the hair count area at subsequent time points. If the ink dot faded between study visits, it was redone. For the macrophotography, hair was clipped before each photograph. Change from BL is defined as the post-BL value minus the BL value. BL value of an assessment is defined as the latest assessment on or before the BL date(latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-BL assessment for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 26 and Week 52|ITT Population. Only participants avilable at the specified time were analysed.|||Hair count||Standard Deviation|Mean
2632780|NCT01831791|Secondary|Mean Change From Baseline (BL) in Target Area Hair Width Within a 2.54 cm Diameter Circle at Week 26 and Week 52|Target area hair width was based on the total width of the nonvellus hairs(>=30μm in width) within a target 2.54cm(1 inch) diameter circle at the vertex and was assessed by macrophotographic technique. A cosmetic ink dot was placed by means of a tattoo at BL on the scalp in the center of the circle as a marker to guide the placement of the hair count area at subsequent time points. If the ink dot faded between study visits, it was redone. For the macrophotography, hair was clipped before each photograph. Change from BL is defined as the post-BL value minus the BL value. The BL value of an assessment is defined as the latest assessment on or before the BL date(latest non-missing value of either the treatment start date or the randomization date). The LOCF method for missing data was used by carrying forward the last non-missing post-BL assessment value for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 26, and Week 52|ITT Population. Only participants avilable at the specified time were analysed.|||microns x 10^-3||Standard Deviation|Mean
2632781|NCT01831791|Secondary|Mean Change From Baseline (BL) in Target Area Hair Count Within a 2.54 Centimeter (cm) Diameter Circle at Week 26 and Week 52|Target area hair count is based on the nonvellus hair(>= 30 micrometer[μm] in width) count within a target 2.54cm(1 inch) diameter circle at the vertex and was assessed by macrophotographic technique. A cosmetic ink dot was placed by means of a tattoo at BL on the scalp in the center of the circle as a marker to guide the placement of the hair count area at subsequent time points. If the ink dot faded between study visits, it was redone. For the macrophotography, hair was clipped before each photograph. Change from BL is defined as post-BL value minus BL value. The BL value is defined as the latest assessment on or before the BL date(latest non-missing value of either treatment start date or randomization date). The last observation carried forward(LOCF) method for missing data was used by carrying forward the last non-missing post-BL assessment value for participants with missing data and/or for participants who discontinued from the study.|Baseline, Week 26, and Week 52|ITT Population. Only participants avilable at the specified time were analysed.|||Hair count||Standard Deviation|Mean
2632782|NCT01831791|Primary|Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. The number of participants answering yes/no responses to questions about suicidal ideation (Question [Que] 1 and Que 2) at Baseline and post-Baseline (since last visit) and suicidal behaviors (Que 6 - Que 10) at post-Baseline (since last visit) are presented. Questions included the presence (yes) or absence (no) of the following: Que 1 - a wish to be dead; Que 2 - nonspecific (NS) active suicidal thoughts; Que 6 - preparatory acts or behavior; Que 7 - aborted attempt; Que 8 - interrupted attempt (int. att.); Que 9 - non-fatal actual suicide attempt; Que 10 - completed suicide and non-suicidal self-injurious behavior. Final assessment (FA) is the last post-Baseline measurement during the study.|Baseline, Week 26 and Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
2632783|NCT01831791|Primary|Mean Change From Baseline in Heart Rate at the Indicated Time Points|Vital sign monitoring included heart rate measurement at the Screening visit, Baseline visit, Weeks 13, 26, 39, and 52 visits and the early withdrawal visit if applicable. Change from Baseline in heart rate is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline visit, Weeks 13, 26, 39, and 52 visits and or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|||Beats per minute||Standard Deviation|Mean
2632895|NCT01830881|Secondary|Number of Participants With Need for Additional Postoperative Pain Medication|Subjects will be assessed 30 minutes postoperatively for need of additional pain medications.|30 minutes postoperatively|One participant in the Midazolam group left the study. One participant in the placebo group decided not to have the procedure.|||Participants|||Count of Participants
2632784|NCT01831791|Primary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points|Blood pressure measurements were taken to observe vital signs and included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the Screening visit, Baseline visit, Weeks 13, 26, 39, and 52 visits and the early withdrawal visit if applicable. Change from Baseline in SBP and DBP is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Weeks 13, 26, 39, and 52 visits and or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2632785|NCT01831791|Primary|Number of Participants With Any Laboratory Value Shifts From Baseline at Any Time Post-baseline|Blood samples for the assessment of the indicated laboratory parameters were taken at the Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. The laboratory parameters included ALP, ALT, AST, total bilirubin, total protein, sodium, potassium, albumin, glucose, creatinine, urea/BUN, hemoglobin, hematocrit, red blood cell (RBC) count, platelet count, white blood cell (WBC) count, and prostate-specific antigen (PSA). A laboratory value (LV) that is within the normal range is considered normal. A LV that is above the upper limit of the normal range is considered high abnormal. A LV that is below the lower limit of the normal range is considered low abnormal. Number of participants with any LV shifts from BL at any time post-BL are presented for, normal at BL to abnormal; normal at BL to high; normal at BL to low; normal or low at BL to high; normal or high at BL to low.|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only participants with a normal BL and at least one post-BL LV are analysed. ITT Population (represented by n=X in the category titles).|||Participants|||Number
2632786|NCT01831791|Primary|Mean Change From Baseline in Prostate-specific Antigen at the Indicated Time Points|Blood samples were collected for the measurement of prostate-specific antigen at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the prostate-specific antigen value is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Microgram per liter (µg/L)||Standard Deviation|Mean
2632787|NCT01831791|Primary|Mean Change From Baseline in Potassium, Sodium, Glucose and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points|Blood samples were collected for the measurement of potassium, sodium, glucose and urea/BUN at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the potassium, sodium, glucose and urea/BUN values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2632788|NCT01831791|Primary|Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points|Blood samples were collected for the measurement of total bilirubin and creatinine at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the total bilirubin and creatinine values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2632789|NCT01831791|Primary|Mean Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) at the Indicated Time Points|Blood samples were collected for the measurement of ALT, ALP and AST at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the ALT, ALP and AST values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Units per liter (U/L)||Standard Deviation|Mean
2632896|NCT01830881|Secondary|Subject Sleepiness 30 Minutes Postprocedure|Subject sleepiness will be assessed 30 minutes postoperatively using a 100mm Visual Analog Scale with 0mm being None and 100mm being Worst Imaginable|30 minutes postoperatively||||units on a scale||Standard Deviation|Mean
2632790|NCT01831791|Primary|Mean Change From Baseline in Red Blood Cells Count at the Indicated Time Points|Blood samples were collected for the measurement of the red blood cell count at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the red blood cell count value is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
2632791|NCT01831791|Primary|Mean Change From Baseline in Platelet Count and White Blood Cell Count at the Indicated Time Points|Blood samples were collected for the measurement of platelet count and white blood cell count at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the platelet count and white blood cell count values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||10^9 cells/Liter (GI/L)||Standard Deviation|Mean
2632792|NCT01831791|Primary|Mean Change From Baseline in Hematocrit at the Indicated Time Points|Blood samples were collected for the measurement of hematocrit at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the hematocrit value is summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2632793|NCT01831791|Primary|Mean Change From Baseline in Hemoglobin, Albumin and Total Protein at the Indicated Time Points|Blood samples were collected for the measurement of hemoglobin, albumin and total protein at Baseline, Week 26 and Week 52 visits and the early withdrawal visit where applicable. Change from Baseline in the hemoglobin, albumin and total protein values are summarized for each post-Baseline assessment as well as for the final assessment (the last post-Baseline value in the study [final value]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value of an assessment is defined as the latest assessment on or before the Baseline date (latest non-missing value of either the treatment start date or the randomization date).|Baseline, Week 26 and 52 visits and/or early withdrawal visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per liter (g/L)||Standard Deviation|Mean
2632794|NCT01831791|Primary|Number of Participants With Change From Baseline in Breast Examination Results Any Time Post-Baseline Visit|A qualitative breast examination was performed at Baseline (Week 0), at the Week 26 Visit and at the Week 52 Visit (and at the early withdrawal visit, if applicable). Participants were assessed for presence (reported as yes) and absence (reported as no) of palpable breast tissue (PBT) or nipple tenderness (NT) and/or clinically significant (CS) PBT or NT at Baseline (BL), at each scheduled Post-BL assessment. Change from BL in breast examination results included the number of participants with change from 'no (N)' at BL to 'yes (Y)' at any Post-BL assessment for the presence of PBT or NT, and the number of participants with change from N at BL in CS to Y at any Post-BL assessment in CS for PBT and for NT. BL value of an assessment is defined as the latest assessment on or before the BL date (latest non-missing value of either the treatment start date or the randomization date).|Baseline to Week 52|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
2632795|NCT01831791|Primary|Number of Participants With Drug-related, Treatment-emergent AEs and AE Leading to Premature Study Drug Discontinuation and Possible Suicidality-related Adverse Event (PSRAE)|An AE is considered drug-related if the relationship variable indicates so, or if the variable value is missing. Any AE with a start date on or after the treatment start date and on or before the last dose of treatment is considered on-treatment (treatment-emergent). This includes an AE with a missing onset date. Any AE which occurred, in the investigator's judgement and is possibly related to suicidality, is defined as possible suicidality-related adverse event (PSRAE). Suicidality was assessed by using the columbia-suicide severity rating scale (C-SSRS) as determined by the investigator. The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors.|From Baseline (Week 0) until Week 52|ITT Population|||Participants|||Number
2632807|NCT01831726|Secondary|Overall Response (OR) of Partial Response (PR) or Greater|Overall Response (OR) of Partial Response (PR) or greater based on local investigator assessment. For patients with solid tumors, the assessment criteria will be RECIST 1.1 and will include responses of CR and/or PR. For hematologic tumors other appropriate hematological response criteria will apply and are included in the appendices. ORR: CR+PR|Week 16|"Full Analysis Set (FAS) included all patients who received at least one dose of study drug.~FAS was used for the analysis of efficacy endpoints."|||number of participants|||Number
2632796|NCT01831791|Primary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, drug-induced liver injury, breast cancer in male participants, prostate cancer, spontaneous abortion in female partner of male participants|From Baseline (Week 0) until Week 52|Intent-to-Treat (ITT) Population: comprised of all participants who received a randomization number, regardless of whether or not treatment was administered|||Participants|||Number
2632797|NCT01831765|Secondary|Change in PPG (Postprandial Glucose)|Change from baseline in PPG and PPG increment (meal test) after 52 weeks of randomised treatment.|Week 0, week 52|The FAS included all randomised subjects. The number of subjects with data available for PPG at 120 mins at baseline were 379, 379 and 380, 380 at week 52 and for PPG increment (120 mins) at baseline were 379, 375 and 381, 380 at week 26 for faster aspart (meal) and Novorapid (meal) respectively.|||mmol/L||Standard Deviation|Mean
2632798|NCT01831765|Secondary|Change in HbA1c|Change from baseline in HbA1c (%) after 52 weeks of randomised treatment.|Week 0, week 52|The FAS included all randomised subjects. The statistical evaluation of the FAS was to follow the ITT principle and subjects contributed to the evaluation ‘as randomised’. For this endpoint, baseline and week 52 have been presented, where week 52 data is the end of trial containing last available measurement.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
2632799|NCT01831765|Secondary|Frequency of Adverse Events|All treatment emergent adverse events (TEAEs) from baseline until 52 weeks of randomised treatment. A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment.|After 52 weeks of randomised treatment|The safety analysis set included all subjects receiving at least one dose of trial product/its comparator and contributed to the evaluation “as treated”. Five (5) subjects randomised to the faster aspart (post) group have consistently taken their bolus insulin before meals throughout the trial and are handled as treated with faster aspart (meal).|||event /100 patient yrs of exposure|||Number
2632800|NCT01831765|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight after 26 weeks of randomised treatment.|Week 0, week 26|The FAS included all randomised subjects. For this endpoint baseline, and week 26 have been presented, where week 26 data is end of trial containing last available measurement. At baseline (week 0) 381, 382, 378 and 381, 382, 380 subjects at week 26 were analysed for faster aspart (meal), faster aspart (post) and Novorapid (meal) arms respectively.|||Kg||Standard Deviation|Mean
2632801|NCT01831765|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes|Observed rate of treatment emergent severe or BG confirmed hypoglycaemic events per 100 patient years of exposure (PYE) from baseline until week 26. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. Severe or BG confirmed is an episode that is severe according to the American Diabetes Association (ADA) classification (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.|From baseline until week 26|The safety analysis set included all subjects receiving at least one dose of trial product/its comparator and contributed to the evaluation “as treated”. Five (5) subjects randomised to the faster aspart (post) group have consistently taken their bolus insulin before meals throughout the trial and are handled as treated with faster aspart (meal).|||event rate/100 patient yrs of exposure|||Number
2632802|NCT01831765|Secondary|Change From Baseline in HbA1c (Post Meal Arm)|Change from baseline in HbA1c (post meal arm) after 26 weeks of randomised treatment.|Week 0, week 26|This endpoint was summarised using the FAS, which included all randomised subjects. For this endpoint, baseline and week 26 have been presented, where week 26 data is end of trial containing last available measurement.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
2632803|NCT01831765|Secondary|Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test)|Change from baseline in 2-hour PPG increments after 26 weeks of randomised treatment (meal test).|Week 0, week 26|The FAS included all randomised subjects. For this endpoint, baseline and week 26 have been presented, where week 26 data is end of trial containing last available measurement. At baseline (week 0) 379, 377, 375 and 381, 382, 380 subjects at week 26 were analysed for faster aspart (meal), faster aspart (post) and Novorapid (meal) arms respectively.|||mmol/L||Standard Deviation|Mean
2632804|NCT01831765|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c after 26 weeks of randomised treatment.|Week 0, week 26|The FAS included all randomised subjects. For this endpoint, baseline and week 26 have been presented, where week 26 data is end of trial containing last available measurement.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
2632805|NCT01831726|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. If a patient is not known to have died, survival time will be censored at the date of the last contact|36 months|"Full Analysis Set (FAS) included all patients who received at least one dose of study drug.~FAS was used for the analysis of efficacy endpoints."|||months||95% Confidence Interval|Median
2632806|NCT01831726|Secondary|Progression-Free Survival (PFS)|Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any cause.|36 months|"Full Analysis Set (FAS) included all patients who received at least one dose of study drug.~FAS was used for the analysis of efficacy endpoints."|||months||95% Confidence Interval|Median
2632844|NCT01831258|Other Pre-specified|Apnea Hypopnea Index (AHI)|Collected through the device|2 weeks|Only 61 participant data was available.|||events/hour||Standard Error|Mean
2653320|NCT01644240|Primary|t½|Time to 50% plasma concentration|Day 1|Subjects did not meet extrapolation criteria and were not included in the analysis.|||hours||Standard Deviation|Mean
2632808|NCT01831726|Primary|Clinical Benefit Rate (CBR)|CBR determined by investigator assessment for each tumor assessment & defined as responses of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) ≥ 16 wks. Confirmed CR/PR or SD prior to 16 wks,but discontinued prior to 16 wks for reasons other than progressive disease,will have their clinical benefit defined non-evaluable; confirmed CR/PR or SD prior to 16 wks,but progressed prior to 16 wks,will be considered not achieving clinical benefit;if CR/PR/SD occurred prior to 16 wks,but progressed at or after 16 wks without evidence of CR/PR/SD at or after 16 wks,will also be considered not achieving clinical benefit. CBR will be analyzed by comparing achieved CBR with a historical control rate of each tumor type,& if there is at least 90% probability that the response rate in a tumor type exceeds the historical rate,then the tumor type will be considered a success. CBR: CR+PR+SD the assessment criteria was RECIST 1.1|Week 16|"Full Analysis Set (FAS) included all patients who received at least one dose of study drug.~FAS was used for the analysis of efficacy endpoints."|||number of participants|||Number
2632809|NCT01831544|Secondary|Explants|"Explants~Note: No endpoints were reached, so this objective was not analyzed"|Six month and two years|No data displayed because Outcome Measure has zero total participants analyzed||||||
2632810|NCT01831544|Secondary|Transplantations|"Transplantations~Note: No endpoints were reached, so this objective was not analyzed"|Six month and two years|No data displayed because Outcome Measure has zero total participants analyzed||||||
2632811|NCT01831544|Secondary|Re-Hospitalizations|"Re-Hospitalizations, excluding planned procedures~Note: No endpoints were reached, so this objective was not analyzed"|Six month and two years|No data displayed because Outcome Measure has zero total participants analyzed||||||
2632812|NCT01831544|Secondary|Length of Operative Time and Initial Hospital Stay|"Length of operative time and initial hospital stay~Note: No endpoints were reached, so this objective was not analyzed"|Six month and two years|No data displayed because Outcome Measure has zero total participants analyzed||||||
2632813|NCT01831544|Secondary|Frequency and Rates of Adverse Events(AEs)|"Frequency and rates of adverse events(AEs) throughout VAD support per INTERMACS Definition~Note: No endpoints were reached, so this objective was not analyzed"|Six month and two years|No data displayed because Outcome Measure has zero total participants analyzed||||||
2632814|NCT01831544|Secondary|Functional Status Change, as Measured by NYHA and 6-minute Walk|"Functional status change, as measured by NYHA and 6-minute walk~Note: No endpoints were reached, so this objective was not analyzed"|Six month and two years|No data displayed because Outcome Measure has zero total participants analyzed||||||
2632815|NCT01831544|Secondary|Health Status Change, as Measured by KCCQ and EuroQol EQ-5D-5L|"Health Status change, as measured by KCCQ and EuroQol EQ-5D-5L~Note: No endpoints were reached, so this objective was not analyzed"|Six month and two years|No data displayed because Outcome Measure has zero total participants analyzed||||||
2632816|NCT01831544|Secondary|Incidence of Neurological Dysfunction|"Incidence of neurological dysfunction per INTERMACS definition~Note: No endpoints were reached, so this objective was not analyzed"|Six month and two years|No data displayed because Outcome Measure has zero total participants analyzed||||||
2632817|NCT01831544|Secondary|Incidence of Major Infection|"Incidence of major infection, per INTERMACS definition~Note: No endpoints were reached, so this objective was not analyzed"|Six month and two years|No data displayed because Outcome Measure has zero total participants analyzed||||||
2632818|NCT01831544|Secondary|Incidence of All Device Failures and Device Malfunctions|"Incidence of all device failures and device malfunctions per INTERMACS definition~Note: No endpoints were reached, so this objective was not analyzed"|Six month and two years|No data displayed because Outcome Measure has zero total participants analyzed||||||
2632819|NCT01831544|Secondary|Incidence of Major Bleeding|"Incidence of major bleeding, per INTERMACS definition~Note: No endpoints were reached, so this objective was not analyzed"|Six month and two years|No data displayed because Outcome Measure has zero total participants analyzed||||||
2632820|NCT01831544|Secondary|Survival|Overall Survival (Time to Death)|Six month and two years|One participant died|||months|||Number
2632821|NCT01831544|Secondary|Survival|Survival at 24 months presented as a simple proportion. Transplants, explants for recovery and exchanges (to a device other than the MVAD® pump) prior to 24 month follow-up will be eligible for endpoint analysis, with survival status identified at the time of procedure.|Two years||||Participants|||Count of Participants
2632822|NCT01831544|Primary|Survival|Primary Endpoint: survival at 6 months presented as a simple proportion. Transplants, explants for recovery and exchanges (to a device other than the MVAD® pump) prior to 6 month follow-up will be eligible for endpoint analysis, with survival status identified at the time of procedure.|Six month||||Participants|||Count of Participants
2632823|NCT01831466|Secondary|Percentage of Participants Achieving a PtGA Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8 for Participants With a PtGA Score ≥2 at Baseline|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 8|FASm. Only observed data were analyzed.|||Percentage of Participants|||Number
2632824|NCT01831466|Secondary|Percentage of Participants Achieving a Patient's Global Assessment (PtGA) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12 for Participants With a PtGA Score ≥2 at Baseline|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 12|FASm. Only observed data were analyzed.|||Percentage of Participants|||Number
2632825|NCT01831466|Secondary|Change From Baseline to Week 8 in the DLQI Total Score|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire assesses participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 8|FASm. Only observed data were analyzed.|||Score on a Scale||Standard Deviation|Mean
2632845|NCT01831258|Other Pre-specified|Leak|The amount of Continuous Positive Airway Pressure (CPAP) leak was obtained through the device|One night|Obtained only 61 participant CPAP data.|||L/min||Standard Error|Mean
2653321|NCT01644240|Primary|Tmax|Time to maximum plasma concentration|Day 1||||hours||Full Range|Median
2632826|NCT01831466|Secondary|Change From Baseline to Week 12 in the Dermatology Life Quality Index (DLQI) Total Score|DLQI is the dermatology-specific quality of life measure used for psoriatic population. The 10-item questionnaire assesses participant health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI questions are rated by the participant as 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 12|FASm. Only observed data were analyzed.|||Score on a Scale||Standard Deviation|Mean
2632827|NCT01831466|Secondary|Change From Baseline to Week 8 in Clinic-Based ISI Scores|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI. Participants were asked to assess their worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms no itching (0) and worst possible itching (10) at the ends. Participants completed the ISI assessments at the clinic (i.e., clinic-based)."|Baseline, Week 8|FASm. Only observed data were analyzed.|||Score on a Scale||Standard Deviation|Mean
2632828|NCT01831466|Secondary|Change From Baseline to Week 12 in Clinic-Based Itch Severity Item (ISI) Scores|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI. Participants were asked to assess their worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms no itching (0) and worst possible itching (10) at the ends. Participants completed the ISI assessments at the clinic (i.e., clinic-based)."|Baseline, Week 12|FASm. Only observed data were analyzed.|||Score on a Scale||Standard Deviation|Mean
2632829|NCT01831466|Secondary|Percent Change From Baseline to Week 8 in BSA Affected With Psoriasis|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. BSA (%)=the sum of the BSAs of the 4 body regions. BSA assessment excluded head and neck, palms, finger nails, soles and toe nails.|Baseline, Week 8|FASm. Only observed data were analyzed.|||Percent Change from Baseline||Standard Deviation|Mean
2632830|NCT01831466|Secondary|Percent Change From Baseline to Week 12 in Body Surface Area (BSA) Affected With Psoriasis|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. BSA (%)=the sum of the BSAs of the 4 body regions. BSA assessment excluded head and neck, palms, finger nails, soles and toe nails.|Baseline, Week 12|FASm. Only observed data were analyzed.|||Percent Change from Baseline||Standard Deviation|Mean
2632831|NCT01831466|Secondary|Percentage of Participants Achieving PASI75, Relative to Baseline at Week 8|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.|Baseline, Week 8|FASm. A participant with a missing value was considered a non-responder.|||Percentage of Participants|||Number
2632832|NCT01831466|Secondary|Percentage of Participants Achieving at Least a 75% Reduction in PASI Response (PASI75), Relative to Baseline at Week 12|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.|Baseline, Week 12|FASm. A participant with a missing value was considered a non-responder.|||Percentage of Participants|||Number
2632833|NCT01831466|Secondary|Percent Change From Baseline to Week 8 in PASI|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.|Baseline, Week 8|FASm. Only observed data were analyzed.|||Percent Change from Baseline||Standard Deviation|Mean
2632834|NCT01831466|Secondary|Percent Change From Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 regions: head, arms, trunk, legs. For each region, percent (%) area of skin involved was estimated: 0=0% to 6=90-100%. Severity was estimated by clinical signs: erythema, induration, scaling; scale: 0=none to 4=maximum. Final PASI = sum of severity parameters for each region*area score*weight of region (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0=no disease to 72=maximal disease. The maximum PASI score was <72 since the PASI assessment excluded scalp, palms, finger nails, soles, and toe nails.|Baseline, Week 12|FASm. Only observed data were analyzed.|||Percent Change from Baseline||Standard Deviation|Mean
2632846|NCT01831258|Secondary|Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity|"Collected through the Patient Global Impression of Change (PGI).The questions ask Since beginning CPAP therapy, how would you describe the chance (if any) in symptoms related to your OSA. The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference."|4 weeks|Data for 64 participant were available|||units on a scale||Standard Error|Mean
2672098|NCT01472549|Secondary|Number of Participants With Re-admissions or Office Visits for Wound-related Problems||30 days||||Participants|||Count of Participants
2632835|NCT01831466|Secondary|Percentage of Participants Achieving a PGA-G Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8|Clinical signs of plaque psoriasis (E, I and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. After scoring each of the PGA subscores, a clinical evaluator of psoriasis performed an assessment of the overall severity of psoriasis and assigned a PGA-G score and category. 0=Clear, except for any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation) and 1=almost clear, the psoriasis is not entirely cleared and remaining plaques are light pink (not including post inflammatory hyperpigmentation), and/or have barely palpable elevation and/or have occasional fine scale. The PGA-G was a static assessment; i.e., without regard to a previous assessment.|Baseline, Week 8|FASm. A participant with a missing value was considered a non-responder.|||Percentage of Participants|||Number
2632836|NCT01831466|Secondary|Percentage of Participants Achieving a Gestalt Physician's Global Assessment (PGA-G) Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 12|Clinical signs of plaque psoriasis (E, I and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. After scoring each of the PGA subscores, a clinical evaluator of psoriasis performed an assessment of the overall severity of psoriasis and assigned a PGA-G score and category. 0=Clear, except for any residual discoloration (post-inflammatory hyperpigmentation and/or hypopigmentation) and 1=almost clear, the psoriasis is not entirely cleared and remaining plaques are light pink (not including post inflammatory hyperpigmentation), and/or have barely palpable elevation and/or have occasional fine scale. The PGA-G was a static assessment; i.e., without regard to a previous assessment.|Baseline, Week 12|FASm. A participant with a missing value was considered a non-responder.|||Percentage of Participants|||Number
2632837|NCT01831466|Secondary|Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 8|Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.|Week 8|FASm. A participant with a missing value was considered a non-responder.|||Percentage of Participants|||Number
2632838|NCT01831466|Secondary|Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) at Week 12|Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.|Week 12|FASm. A participant with a missing value was considered a non-responder.|||Percentage of Participants|||Number
2632839|NCT01831466|Primary|Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and ≥2 Grade/Point Improvement From Baseline at Week 8|Clinical signs of plaque psoriasis (E, I, and S) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.|Baseline, Week 8|FASm. A participant with a missing value was considered a non-responder.|||Percentage of Participants|||Number
2632840|NCT01831466|Primary|Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/Point Improvement From Baseline at Week 12|Clinical signs of plaque psoriasis (erythema [E], induration [I], and scaling [S]) were scored separately according to a 5-point severity scale (0 to 4) to provide PGA subscores, which described the overall severity of each clinical sign. The PGA-C was a static assessment; i.e., without regard to a previous assessment. The PGA subscores are then summed and averaged after which the total average was rounded to the nearest whole number to determine the PGA-C score and category. A higher score indicated a higher level of severity. 0 is equal to (=) cleared except for any residual discoloration and 1=almost clear, majority of lesions had individual scores for E+I+S that when summed, averaged, and rounded equaled 1.|Baseline, Week 12|The mild/moderate full analysis set (FASm) included all participants in the FAS with a baseline PGA-C disease severity of mild (2) or moderate (3). A participant with a missing value was considered a non-responder.|||Percentage of Participants|||Number
2632841|NCT01831258|Secondary|Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change|"Collected through the Patient Global Impression of Change (PGI).The questions ask Since beginning CPAP therapy, how would you describe the change (if any) in overall quality of life related to your OSA?. The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference."|4 weeks|Data for 64 participant were available|||units on a scale||Standard Error|Mean
2632842|NCT01831258|Post-Hoc|Adherence in Patients With Signs of Moderate Clinical Insomnia|Adherence from the device (during their entire study period) in patients with moderate clinical insomnia (Insomnia Severity Index 15 or over)|8 weeks|Only participant with moderate clinical insomnia (Insomnia Severity Index of 15 and over) were included in the post-hoc.|||minutes||Standard Error|Mean
2632843|NCT01831258|Post-Hoc|Adherence in Patients With Signs of Moderate Clinical Insomnia|Adherence from the device (during their first treatment arm) in patients with moderate clinical insomnia (Insomnia Severity Index 15 or over)|4 weeks|Only participant with moderate clinical insomnia (Insomnia Severity Index of 15 and over) were included in the post-hoc.|||minutes||Standard Error|Mean
2672099|NCT01472549|Secondary|Length of Hospital Stay||30 days||||days||Inter-Quartile Range|Median
2632848|NCT01831258|Secondary|OSA Impact of Daily Life|Collected through the Short Functional Outcomes of Sleep Questionnaire (FOSQ-10). The questionnaire has 10 questions which ask how daytime sleepiness has impacted their quality of life. Each question has a scale of 1 = yes extreme to 4 = No. Lower total score (min 10) means that the disease is affecting your quality of life while a higher total score (maximum 40) means that the disease is not affecting your quality of life.|4 weeks|Data for 62 participant were available|||units on a scale||Standard Error|Mean
2632849|NCT01831258|Secondary|Insomnia Severity Index (Subjective Sleep Quality)|Collected through the Insomnia Severity Index (ISI). There are seven question with each question having a scale of 0 (no issue) to 4 (very severe). The total score is added up. If the participant has a total score of 0-7 = no clinical significant insomnia, total score of 8-14 = sub threshold insomnia, total score of 15-21 = clinical insomnia (moderate), total score of 22-28 = clinical insomnia (severe).|4 weeks|Data for 63 participant were available|||units on a scale||Standard Error|Mean
2632850|NCT01831258|Secondary|Daytime Sleepiness (Subjective Sleep Quality)|Collected through the Epworth Sleepiness Scale (ESS) which is a subjective questionnaire and the participant answer 8 question with rating on the chance of dozing (from 0= no chance of dozing to 3 = high chance of dozing). The total is added with a range from 0-24. A total score of 0 means that the participant is not experiencing day time sleepiness, while total score of 24 means that the participant si extremely sleepy during the daytime.|4 weeks|Data for 65 participant were available|||units on a scale||Standard Error|Mean
2632851|NCT01831258|Primary|Adherence to CPAP Treatment|Average used minutes (all days) taken from the CPAP device.|2 weeks|Adherence data could only be obtained for 61 participants|||mins||Standard Error|Mean
2632852|NCT01831232|Secondary|Rate of Complete Remission (CR), Remission With Incomplete Blood Count Recovery (CRi) and Partial Remission (PR)|Complete remission (CR) - includes patients with good CR and CR with minimal residual disease (MRD); remission with incomplete blood count recovery (CRi), partial remission (PR)|35 days|All patient who received IAP treatment were assessed for response. The number of participants with CR, CRi and PR are included in the table below.|||Participants|||Count of Participants
2632853|NCT01831232|Secondary|Number of Biomarker-positive Participants With Clinical Responses|"Biomarkers: FLT3-ITD positive, NPM1 positive, CEBPA. A good CR is defined as <5% blasts in the marrow by morphologic evaluation along with the absence of any MRD by flow cytometry or cytogenetics and recovery of blood counts (platelets >100,00 and absolute neutrophil count >1,000) by day 35 after induction. Cheson AML Response Criteria is used for Morphologic Leukemia Free State, Morphologic Complete Remission, Cytogenetic Complete Remission (CRc), Molecular Complete Remission (CRm), Morphologic Complete Remission with Incomplete Blood Count Recovery (CRi), Partial Remission (PR), Treatment Failure, Recurrence (Progressive Disease)."|38 days after dosing|Participants with biomarkers: FLT3-ITD positive, NPM1 positive or CEBPA|||participants with clinical responses|||Number
2632854|NCT01831232|Secondary|Overall Survival|Amount of time a patient lives after treatment with IAP|1 year after treatment with IAP||||percentage of patients surviving||95% Confidence Interval|Number
2632855|NCT01831232|Secondary|Progression Free Survival (PFS)||1 year after treatment with IAP|Patients who had a good complete remission (CR), CR with evidence of minimal residual disease (MRD), or complete remission with incomplete blood count recovery (CRi) following treatment. Cheson AML Response Criteria are used to assess response.Good CR is defined as <5% blasts in marrow, no MRD and recovery of blood counts by day 35 after induction.|||percentage of patients with PFS||95% Confidence Interval|Number
2632856|NCT01831232|Primary|Number of Participants With TRM.|"A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used.~TRM: Treatment Related Mortality"|28 days||||participants||95% Confidence Interval|Number
2632857|NCT01831232|Primary|Number of Participants With Good Complete Remission (CR)|"A Bayesian design intended to simultaneously monitor efficacy and toxicity will be used.~Definition of Good CR: Conventional criteria for CR (absolute neutrophil count > 1,000/uL, platelet count > 100,000/uL, marrow with <5% morphologic blasts) and additionally the requirements that marrow Minimal Residual Disease (MRD) - detected by 10-color flow cytometry or conventional cytogenetic evaluation - be absent and that the above blood counts be obtained."|35 days||||Participants|||Count of Participants
2632858|NCT01831219|Other Pre-specified|Number of Operated Hips That Required Revision/Reoperation|Implant survivorship will be determined from the medical history CRF by comparing the percentage of ROBODOC and manual control subjects who have required revision or re-operation THA procedures on the hip in question since their original study procedure which took place 7-20 years previously.|At follow-up visit (7-20 years post-operatively)||||Hips|Hips||Number
2632859|NCT01831219|Secondary|Visual Analog Pain Score|"The Visual Analog Scale pain questionnaire will be used to measure clinical outcome. The pain VAS is a continuous scale which range from 0 (no pain) to 100 [100-mm scale] (worst imaginable pain )."|2 months||||units on a scale|Hips|Standard Deviation|Mean
2632860|NCT01831219|Secondary|UCLA Activity Score|The UCLA Activity Score will be used to measure clinical outcome. The UCLA Activity Score ranges 10 (best) to 0 (worst).|2 months||||units on a scale|Hips|Standard Deviation|Mean
2632861|NCT01831219|Secondary|Health Status Questionnaire-12|The Health Status Questionnaire-12 (HSQ-12) will be used to measure clinical outcome. HSQ-12 total score ranges from 0 (worst) to 800 (best).|2 months||||units on a scale|Hips|Standard Deviation|Mean
2632862|NCT01831219|Secondary|Harris Hip Score|The Harris Hip Score will be measured to determine clinical outcome. The Harris Hip total score ranges 100 (best) to 0 (worst) and it is computed by the sum of the pain score (0-44 points), function (, 0-47 points), absence of deformity (4 points), and range of motion (5 points).|2 months||||units on a scale|Hips|Standard Deviation|Mean
2632863|NCT01831219|Primary|Western Ontario and McMaster Universities Osteoarthritis Index|The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used to measure clinical outcome. The WOMAC total score ranges 96 (best) to 0 (worst). The WOMAC pain score ranges 0-20, the stiffness score ranges 0-8, and functional limitation score ranges 0-68.|2 months||||units on a scale|Hips|Standard Deviation|Mean
2632864|NCT01831219|Primary|Presence of Osteolysis|Presence of osteolysis determined by looking at patient x-rays as described by Gruen et al and Johnson et al.|14 months||||Hips|Hips||Number
2632897|NCT01830881|Secondary|Subject Vital Signs (Oxygenation Saturation) 30 Minutes Postprocedure|Subject vital signs (oxygenation saturation) will be assessed 30 minutes postoperatively|30 minutes postoperatively||||percent saturation||Standard Deviation|Mean
2632865|NCT01831154|Secondary|Intraoperative Glycemic Stability in Patients Undergoing Open Heart Surgery Compared Between Three Glycemic Protocols.|Intraoperative glycemic stability was operationalize as how often blood glucose levels were maintained as normal or maintained in the preset target ranges for each group. If intraoperative blood glucose levels fell outside of normal (hypoglycemia or hyperglycemia) or, outside the preset target ranges, for each protocol, for 3 consecutive blood glucoses (1.5 hours) despite insulin therapy a marker of inadequate glycemic control was recorded.|Measures of blood glucose every 30 minutes starting on entry into the operating room until exiting the operating room or 240 minutes whichever event occurred first|Inclusion > age 21, underwent elective or urgent CABG with or without combined valve surgery or valve surgery alone, on or off CPB. Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections. No data analysis could be performed because there were too few episodes of glycemic instability.|||episodes out of target glucose range|||Number
2632866|NCT01831154|Secondary|The Effect of Tight Glycemic Control on Intensive Care Unit Length of Stay in Patients Undergoing Open Heart Surgery|Length of stay (LOS) in the intensive care unit was measured by the total number of days each patient stayed in the intensive care unit.|ICU days measured every day the patient stayed in ICU starting with entry into the ICU from the Operating Room until discharge from the ICU to the ward|Inclusion > age 21, underwent elective or urgent CABG with or without combined valve surgery or valve surgery alone, on or off CPB. Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections.|||days||Standard Deviation|Mean
2632867|NCT01831154|Secondary|Intraoperative Blood Glucose Levels in Patients Undergoing Open Heart Surgery|Blood glucose values were obtained every 30 minutes in the intraoperative period, and were drawn and recorded by the certified registered nurse anesthetist (CRNA) performing the anesthetic. Repeated measured ANOVA with Greenhouse-Geisser correction was employed to determine if participants assigned to the tight glycemic group yielded lower blood glucose levels intraoperatively (every 30 minutes for 240 minutes) than the other two interventions. All blood glucose measures over the intraoperative period were averaged to produce a mean and standard deviation comparing the tight glycemic group to the other two interventional groups, Data points were blood glucose testing collected every 30 minutes starting on entry into the operating room.|Blood glucose measured every 30 minutes starting on entry into the operating room until exiting the operating room or 240 minutes, whichever event occurred first|Inclusion > age 21, underwent elective or urgent CABG with or without combined valve surgery or valve surgery alone, on or off CPB. Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections.|||mg/dl||Standard Deviation|Mean
2632868|NCT01831154|Primary|The Effect of Intraoperative Tight Glycemic Control on Postoperative C-Reactive Protein Plasma Levels in Patients Undergoing Open Heart Surgery|C-Reactive Protein concentrations were collected in addition to clinical signs for indications of infection. These biomarker concentrations were collected after successful separation from cardiopulmonary bypass (CPB), and every morning for five days postoperatively. Values were drawn by anesthesia providers and intensive care unit (ICU) registered nurses or laboratory personnel with the standard morning blood work. All C-Reactive Protein blood values from post cardiopulmonary bypass through postoperative day 5 were collected. The outcome measure was mean C-Reactive Protein values with standard deviation.|Post cardiopulmonary bypass and postoperative day 1 through 5|Inclusion > age 21, underwent elective or urgent CABG with or without combined valve surgery or valve surgery alone, on or off CPB. Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections. Six participants had > 50% missing data and were dropped from this analysis (4 tight, 1 in other two groups).|||Mg/L||Standard Deviation|Mean
2632869|NCT01831154|Primary|The Effect of Intraoperative Tight Glycemic Control on Postoperative Procalcitonin Plasma Levels in Patients Undergoing Open Heart Surgery|Procalcitonin concentrations were collected in addition to clinical signs for indications of infection. These biomarker concentrations were collected after successful separation from cardiopulmonary bypass (CPB), and every morning for five days postoperatively. Values were drawn by anesthesia providers and intensive care unit (ICU) registered nurses or laboratory personnel with the standard morning blood work. All procalcitonin blood values from post cardiopulmonary bypass through postoperative day 5 were collected. The outcome measure was mean procalcitonin values with standard deviation.|Post CPB and Postoperative days 1 through 5|Inclusion > age 21, underwent elective or urgent CABG with or without combined valve surgery or valve surgery alone, on or off CPB. Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections. Six participants had > 50% missing data and were dropped from this analysis (4 tight, 1 in other two groups).|||ng/ml||Standard Deviation|Mean
2632870|NCT01831154|Primary|Number of Participants Undergoing Open Heart Surgery With Postoperative Surgical Site Infection|The presence or absence of deep, or/and superficial sternal wound infection and deep, superficial harvest site infection within in six weeks postoperatively was a primary outcome variable. Infection assessment was performed during the intensive care phase, at hospital discharge, two-week post hospital discharge and six-week post hospital discharge by independent blinded researchers that were part of the cardiothoracic team.|six weeks postoperatively|Inclusion > age 21, underwent elective or urgent Coronary Artery Bypass Graft (CABG) with or without combined valve surgery or valve surgery alone, on or off cardiopulmonary bypass (CPB). Exclusions were patients diagnosed with immunosuppression, end stage organ disease, or active infections.|||participants|||Number
2632871|NCT01831089|Secondary|Quality of Life (QoL)|"Change from baseline to last cycle. European Organization for Research and Treatment of Cancer (EORTC) QLQ-C15-PAL scale scores.~The EORTC QLQ-C15-PAL is an abbreviated 15-item version of the EORTC QLQ-C30 (version 3.0) developed for palliative care. Wilcoxon signed ranks test repeat-measure analyses of variance were used to measure the change value from baseline value. Data has to be analysed following the corresponding EORTC manual http://www.eortc.be/qol/files/SCManualQLQ-C15-PAL.pdf and the overall quality of life assessment is contained in 0 to 100 where a higher value represents a better state."|Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks)||||score on a scale||Standard Deviation|Mean
2632872|NCT01831089|Secondary|Duration of Response (DR)|Duration of response (DR) was defined as the time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented|Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks)|In cohort II, no patients with PR or CR.|||months||95% Confidence Interval|Median
2632874|NCT01831089|Secondary|Best Tumor Response|Best overall response:Best response recorded from the start of the study treatment until the end of treatment Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to<10 mm Partial Response (PR):At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression) Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum diameters while on study Treatment failure (TF):symptomatic deterioration or death due to progression|Through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (1 cycle =3 weeks)||||Participants|||Count of Participants
2632875|NCT01831089|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|DLTs are defined as AEs or laboratory abnormalities related to the study drugs occurred during Cycle 1.|DLT was followed mainly during Cycle 1 through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (cycle duration: 3 weeks)||||Participants|||Count of Participants
2632876|NCT01831089|Primary|Recommended Dose (RD)|"The RD will be the highest DL explored with less than one third of the patients experiencing a DLT during Cycle 1.~DLTs are defined as AEs or laboratory abnormalities related to the study drugs occurred during Cycle 1."|The RD was followed mainly during Cycle 1 through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (cycle duration: 3 weeks)|Three patients at the RD were not evaluable because they did not receive a complete Cycle 1 due to disease-related grade 3 vomiting and early PD, disease-related grade 3 confusional state, and because not enough information for DLT evaluation was collected during Cycle 1.|||mg/m2 / mg FD|||Number
2632877|NCT01831089|Primary|Maximum Tolerated Dose (MTD)|"The MTD will be the lowest level at which one third or more evaluable patients experience a DLT in Cycle 1.~DLTs are defined as AEs or laboratory abnormalities related to the study drugs occurred during Cycle 1."|The MTD was followed mainly during Cycle 1 through study completion, an average of 5 cycles for PM1183 in cohort A and 9.5 cycles in cohort B were observed (cycle duration: 3 weeks)|Three patients at the RD were not evaluable because they did not receive a complete Cycle 1 due to disease-related grade 3 vomiting and early PD, disease-related grade 3 confusional state, and because not enough information for DLT evaluation was collected during Cycle 1.|||mg/m2 / mg FD|||Number
2632878|NCT01831076|Primary|Overall Response Rate as Measured by Clinical Exam, Standard Imaging, and Surgical Pathology Findings|"Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~Evaluated using chi-square analysis."|Up to 6 months||||Participants|||Count of Participants
2632879|NCT01830972|Primary|Interval History: Typical Number of Falls Per Year|Each interval history was intended to record any signs, symptoms, or events (e.g., falls, changes in medications or therapies) experienced by the participant since the prior study visit that were not related to study procedure(s) performed at prior study visits or study drug. Interval history may have included exacerbation or improvement in existing medical conditions (including the clinical manifestations of GNE myopathy) that might have interfered with study participation, safety, and/or positively or negatively impact performance of functional assessments.|Part I: Baseline (Study UX001-CL201 Week 48), Month 6; Part II-IV: Baseline, Months 1, 6, 12, 18, 24, 30, 36, study termination|All participants who received at least one dose of study drug. Naïve Participants did not enter the study until Part II.|||falls||Standard Deviation|Mean
2632880|NCT01830972|Primary|Interval History: Has the Participant Started Receiving Any New Therapy or Discontinued Any Therapies Since Last Study Visit?|Each interval history was intended to record any signs, symptoms, or events (e.g., falls, changes in medications or therapies) experienced by the participant since the prior study visit that were not related to study procedure(s) performed at prior study visits or study drug. Interval history may have included exacerbation or improvement in existing medical conditions (including the clinical manifestations of GNE myopathy) that might have interfered with study participation, safety, and/or positively or negatively impact performance of functional assessments.|Part I: Baseline (Study UX001-CL201 Week 48), Month 6; Part II-IV: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 33, 36, study termination|All participants who received at least one dose of study drug. Participant “n” at each time point includes those with a yes or no response. Naïve Participants did not enter the study until Part II.|||Participants|||Count of Participants
2632881|NCT01830972|Primary|Interval History: Has the Participant Started Taking Any New Medications or Discontinued Any Medications Since the Study Visit?|Each interval history was intended to record any signs, symptoms, or events (e.g., falls, changes in medications or therapies) experienced by the participant since the prior study visit that were not related to study procedure(s) performed at prior study visits or study drug. Interval history may have included exacerbation or improvement in existing medical conditions (including the clinical manifestations of GNE myopathy) that might have interfered with study participation, safety, and/or positively or negatively impact performance of functional assessments.|Part I: Baseline (Study UX001-CL201 Week 48), Month 6; Part II-IV: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 33, 36, study termination|All participants who received at least one dose of study drug. Participant “n” at each time point includes those with a yes or no response. Naïve Participants did not enter the study until Part II.|||Participants|||Count of Participants
2632898|NCT01830881|Secondary|Subject Vital Signs (Oxygenation Saturation)|Subject oxygenation status will be assessed for the duration of the procedure|intraoperatively (30-60 minutes after premedication)||||percent saturation||Standard Deviation|Mean
2632899|NCT01830881|Secondary|Subject's Correct Identification of Receiving Midazolam or Placebo|Number of patient's who could correctly determine if they received study drug or placebo when asked|30 minutes postoperatively||||Participants|||Count of Participants
2632900|NCT01830881|Secondary|Subject Nausea 30 Minutes Postprocedure|Subject nausea will be assessed 30 minutes postoperatively using a 100mm Visual Analog Scale with 0mm being None and 100mm being Worst Imaginable|30 minutes postoperatively||||100-mm visual analog sclae for nausea||Full Range|Mean
2632882|NCT01830972|Primary|Interval History: Has the Participant Experienced Any New Conditions or Exacerbations of an Existing Condition Since Last Study Visit?|Each interval history was intended to record any signs, symptoms, or events (e.g., falls, changes in medications or therapies) experienced by the participant since the prior study visit that were not related to study procedure(s) performed at prior study visits or study drug. Interval history may have included exacerbation or improvement in existing medical conditions (including the clinical manifestations of GNE myopathy) that might have interfered with study participation, safety, and/or positively or negatively impact performance of functional assessments.|Part I: Baseline (Study UX001-CL201 Week 48), Month 6; Part II-IV: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 33, 36, study termination|All participants who received at least one dose of study drug. Participant “n” at each time point includes those with a yes or no response. Naïve Participants did not enter the study until Part II.|||Participants|||Count of Participants
2632883|NCT01830972|Primary|Clinically Significant Changes From Baseline in Vital Signs, Physical and Neurological Examination Findings and Laboratory Evaluations||From first dose of study drug until up to 30 days after the last dose of study drug. Mean (SD) duration of treatment was 1170.0 (170.2) days for Crossover Participants and 897 (380) days for Naïve Participants|Clinically significant changes from Baseline for vital signs, physical and neurological examination findings and laboratory evaluations were recorded as AEs and are reported as part of the Safety section of this record and Outcome Measure 1.||||||
2632884|NCT01830972|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation|An adverse event (AE) is defined as any untoward medical occurrence, whether or not considered drug related. A serious AE (SAE) is an AE that at any dose results in any of the following: death, a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect. TEAEs include all adverse events that start on or after the first dose of study medication, or adverse events that are present prior to the first dose of study medication, but their severity or relationship increases after the first dose of study medication up to and including 30 days after the final study medication dosing date. TEAEs were graded as mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4), or death (grade 5). TEAE relationship to study medication was classified as not related, possibly related, or probably related.|From first dose of study drug until up to 30 days after the last dose of study drug. Mean (SD) duration of treatment was 1170.0 (170.2) days for Crossover Participants and 897 (380) days for Naïve Participants|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2632885|NCT01830933|Primary|Percentage of Participants Who Reported Discussion of Mammography Screening|Self reported discussion of mammography with physician.|up to 14 months||||percentage of participants|||Number
2632886|NCT01830933|Primary|Percentage of Participants Who Had a Discussion of Breast Cancer Risk|Self-reported discussion of breast cancer risk with physicians.|one week post-initial visit (approximately one week)||||percentage of participants|||Number
2632887|NCT01830933|Primary|Percentage of Participants With Correct Perception of Risk|This outcome was measured through a survey. Women were asked what they thought about their risk of getting breast cancer was compared to other women of the same age.|baseline, one week post-initial visit (approximately one week)||||percentage of participants|||Number
2632888|NCT01830933|Primary|Knowledge of Breast Cancer Risk Factors|Risk knowledge was assessed using a post-survey. Participants could have scored 0-100 (with 0 meaning no correct answers, and 100 is all correct answers). This outcome was measured through a survey. Breast cancer risk knowledge was based on a series of eight questions in the survey. O|one week post-initial visit (approximately one week)||||units on a scale||Standard Deviation|Mean
2632889|NCT01830920|Other Pre-specified|Composite of Death, Dialysis, or Sustained Impaired Renal Function|Sustained impaired renal function defined as a 35% increase in SCr from baseline at Day 30.|Day 30|Per Protocol Analysis set|||Participants|||Count of Participants
2632890|NCT01830920|Other Pre-specified|Composite of Death, Dialysis, or Sustained Impaired Renal Function|Sustained impaired renal function defined as a 35% increase in SCr from baseline at Day 30.|Day 30|Per Protocol Analysis set|||Participants|||Count of Participants
2632891|NCT01830920|Secondary|Duration of AKI|AKI is defined using the Scr-KDIGO criteria. Duration of AKI is defined as the number of days from start of AKI (SCr-KDIGO) where either SCr increase ≥ 0.3 mg/dL above pre-AKI reference point (if the value exists) or if SCr increase ≥1.5 times baseline or dialysis in the first 7 days up to discharge if prior to 7 days.|7 days OR up to discharge after surgery|Per Protocol Analysis set|||days||Standard Deviation|Mean
2632892|NCT01830920|Secondary|Severity of AKI|"AKI is defined using the KDIGO criteria, in which AKI is defined as any of the following:~Increase in SCr by ≥0.3 mg/dl (≥26.5 µmol/l) within 48 hours; or~Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or~Urine volume <0.5 ml/kg/h for 6 hours.~Staging of AKI is defined as the following:~Stage 1: SCr 1.5 - 1.9 times baseline OR ≥0.3 mg/dL (≥26.5 µmol/L) increase, Urine output <0.5 ml/kg/hr for 6-12 hours Stage 2: SCr 2.0-2.9 times baseline, Urine output <0.5 ml/kg/h for ≥ 12 hours Stage 3: SCr 3.0 times baseline OR Increase in SCr to ≥5.0 mg/dL (≥353.6 µmol/L) OR Initiation of renal replacement therapy OR In patients <18 years, decrease in eGFR to <35 ml/min per 1.73 m^2, Urine output <0.3 ml/kg/h for ≥24 hours OR Anuria for ≥12 hours.~No AKI is considered the best outcome, and Stage 3 the worst outcome."|7 days|Per Protocol Analysis set|||Participants|||Count of Participants
2632893|NCT01830920|Secondary|Incidence of AKI|"AKI is defined using the SCr-KDIGO criteria, defined as the following:~Increase in SCr by ≥0.3 mg/dl (≥26.5 µmol/l) within 48 hours; or~Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days."|7 days|Per Protocol Analysis set|||Participants|||Count of Participants
2632894|NCT01830920|Primary|Incidence of Acute Kidney Injury (AKI)|"Acute kidney injury (AKI) is defined using the KDIGO criteria, in which AKI is defined as any of the following:~Increase in SCr by ≥0.3 mg/dl (≥26.5 µmol/l) within 48 hours; or~Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or~Urine volume <0.5 ml/kg/h for 6 hours."|7 days|Per Protocol Analysis set -|||Participants|||Count of Participants
2639126|NCT01767506|Secondary|The Proportion of Communities With Clinical Trachoma Prevalence of 5% or Below||24 months|The trial was conducted at the community level|||community|community||Count of Units
2632901|NCT01830881|Secondary|Subject Vital Signs (Heart Rate) 30 Minutes Postprocedure|Subject vital signs (heart rate) will be assessed 30 minutes postoperatively|30 minutes postoperatively|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.|||bpm||Standard Deviation|Mean
2632902|NCT01830881|Secondary|Subject Vital Signs (Heart Rate)|Subject heart rate will be assessed for the duration of the procedure|intraoperatively (30-60 minutes after premedication)|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.|||bmp||Full Range|Mean
2632903|NCT01830881|Secondary|Subject Extent of Sedation|Subject extent of sedation 30-60 minutes after premedication, just prior to procedure as measured by the 6-point Ramsay Scale (1 = patient anxious agitated, or restless; 2 = patient cooperative, oriented, and tranquil; 3 = patient asleep, responds to commands only; 4 = patient asleep, responds to gentle shaking, light glabellar tap, or loud auditory stimulus; 5 = patient asleep, responds to noxious stimuli such as firm nail bed pressure; 6 = patient asleep, has no response to firm nail bed pressure or other noxious stimuli)|30-60 minutes after premedication|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.|||Participants|||Count of Participants
2632904|NCT01830881|Secondary|Subject Extent of Amnesia|To assess the extent of amnesia 1-3 days postoperatively as measured by 100mm Visual Analog Scale with 0mm being Remember Nothing and 100mm being Remember Everything.|1-3 days postoperatively||||mm||Standard Deviation|Mean
2632905|NCT01830881|Secondary|Subject Extent of Amnesia Using Amnesia Score|To assess the extent of amnesia 30 min postoperatively as measured by ability to recall procedure using 4-point scale (0 = unable to recall any proportion of the procedure, 1 = able to recall and describe some portions of the procedure, but overall has minimal recall of the procedure, 2 = able to recall and describe most of the procedure, but admits to inability to recall some portion of the procedure, 3 = able to recall and describe the entire procedure).|30 minutes postoperatively||||Participants|||Count of Participants
2632906|NCT01830881|Secondary|Subject Satisfaction With Pain and Anxiety 1-3 Days Post Procedure|To assess whether oral midazolam is associated with differences in overall patient satisfaction with pain and anxiety control and abortion experience at 1-3 days postoperatively as measured by a mm VAS with 0mm being Not At All Satisfied and 100mm being Very Satisfied|1-3 days post-operatively||||mm on a 100 mm Visual Analog Scale||Standard Deviation|Mean
2632907|NCT01830881|Secondary|Patient Satisfaction With Pain and Anxiety 30 Minutes Postoperatively|To assess whether oral midazolam is associated with differences in overall patient satisfaction with pain and anxiety control and abortion experience at 30 min postoperatively as measured by a mm Visual Analog Scale with 0mm being Not At All Satisfied and 100mm being Very Satisfied|30 minutes post-operatively||||mm on a 100 mm Visual Analog Scale||Standard Deviation|Mean
2632908|NCT01830881|Secondary|State-Trait Anxiety Inventory for Anxiety at Baseline|"To measure the mean State-Trait Anxiety Inventory (STAI) Form Y-1 for anxiety. State anxiety items include: I am tense; I am worried and I feel calm; I feel secure. Trait anxiety items include: I worry too much over something that really doesn't matter and I am content; I am a steady person. Each type of anxiety has its own 4-point scale of 20 different questions that are scored. The 4-point scale for S-anxiety is as follows: 1.) not at all, 2.) somewhat, 3.) moderately so, 4.) very much so. The 4-point scale for T-anxiety is as follows: 1.) almost never, 2.) sometimes, 3.) often, 4.) almost always. Scores range from 20 to 80, with higher scores indicate greater anxiety. State anxiety items and Trait anxiety items were each summed in assessment to provide two total scores for each participant, a State anxiety score and a Trait anxiety score. Mean and standard deviation of total scores for each group are reported."|Baseline (upon entry into study)||||units on a scale||Standard Deviation|Mean
2632909|NCT01830881|Secondary|Subject Perception of Pain During Cervical Dilation|Subjects will be asked to rate pain at the time of cervical dilation by marking along a mm Visual Analog Scale, with 0mm being No Pain and 100mm being Worst Imaginable Pain|with cervical dilation (30-60 minutes after premedication)|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.|||mm||Standard Deviation|Mean
2632910|NCT01830881|Secondary|Subject Perception of Anxiety With Patient Positioning Procedure|Subjects will be asked to rate anxiety prior to starting pelvic exam by marking along a mm Visual Analog Scale, with 0mm being No Anxiety and 100mm being Worst Imaginable Anxiety|prior to starting pelvic exam (30-60 minutes after premedication)|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.|||mm||Standard Deviation|Mean
2632911|NCT01830881|Secondary|Subject Perception of Pain and Anxiety Post Procedure|Subjects will be asked to rate anxiety and pain 30 minutes post-operatively by marking along a mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety|30 minutes post operatively|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.|||mm||Standard Deviation|Mean
2632912|NCT01830881|Secondary|Subject Perception of Pain and Anxiety Upon Entering Procedure Room|Subjects will be asked to rate anxiety and pain upon entering procedure room by marking along a mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety|upon entering procedure room (30-60 minutes after premedication)|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.|||mm||Standard Deviation|Mean
2632913|NCT01830881|Secondary|Subject Anticipated Perception of Pain and Anxiety During Uterine Aspiration at Baseline|Subjects will be asked to rate their anticipated anxiety and pain at the time of uterine aspiration by marking along a mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety|Baseline (upon entry into study)||||mm||Standard Deviation|Mean
2632914|NCT01830881|Primary|Subject Perception of Pain and Anxiety During Uterine Aspiration|Subjects will be asked to rate anxiety and pain at the time of uterine aspiration by marking along a 100 mm Visual Analog Scale, with 0mm being No Pain/Anxiety and 100mm being Worst Imaginable Pain/Anxiety|at time of uterine aspiration (30-60 minutes after premedication)|1 subject in the placebo group did not complete the study after changing mind to have abortion. Baseline information and characteristics on that subject was still collected and included where applicable in study outcomes and data.|||mm||Standard Deviation|Mean
2632915|NCT01830855|Secondary|Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination||One month after third bivalent rLP2086 vaccination (Vac)|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.|||percentage of participants||95% Confidence Interval|Number
2632916|NCT01830855|Secondary|Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains and for Primary Test Starins Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination||One month after third bivalent rLP2086 vaccination|Data was not reported because 3-fold rise analyses was not performed as per change in planned analysis.||||||
2632917|NCT01830855|Secondary|Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination|Results for PMB80[A22] 1:16, PMB2001[A56] 1:8, PMB2948[B24] 1:8 and PMB2707[B44] 1:8 are reported under secondary outcome measure 'Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination.|Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.|||percentage of participants||95% Confidence Interval|Number
2632918|NCT01830855|Secondary|Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination||Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.|||percentage of participants||95% Confidence Interval|Number
2632919|NCT01830855|Secondary|hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination||Before vaccination (Vac) 1, 1 Month after Vac 2|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.|||titer||95% Confidence Interval|Geometric Mean
2632920|NCT01830855|Secondary|Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination||One month after second, third vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point.|||percentage of participants||95% Confidence Interval|Number
2632921|NCT01830855|Secondary|Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|One month after second Bivalent rLP2086 vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point.|||percentage of participants||95% Confidence Interval|Number
2632922|NCT01830855|Secondary|Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2 ,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|Before vaccination 1, 1 Month after Vaccination 2|Evaluable immunogenicity population. Here, N signifies participants valid and determinate hSBA results on all 4 strains at the given time point.|||percentage of participants||95% Confidence Interval|Number
2632923|NCT01830855|Secondary|hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|Before first vaccination, 1 month after third vaccination|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate assay results for the given antigen or strain.|||titer||95% Confidence Interval|Geometric Mean
2632937|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
2632938|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination||Within 30 Days After any Vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
2632924|NCT01830855|Secondary|Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|Before first vaccination, 1 month after third vaccination (Vac)|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.|||percentage of participants||95% Confidence Interval|Number
2632925|NCT01830855|Secondary|Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.|Before first vaccination, 1 month after third vaccination|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point.|||percentage of participants||95% Confidence Interval|Number
2632926|NCT01830855|Primary|Number of Days Participant's Missed School or Work Due to AE During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||days||Standard Deviation|Mean
2632927|NCT01830855|Primary|Percentage of Participants Reporting at Least 1 Immediate AE After Third Vaccination||Within 30 minutes after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||percentage of participants||95% Confidence Interval|Number
2632928|NCT01830855|Primary|Percentage of Participants Reporting at Least 1 Immediate AE After Second Vaccination||Within 30 minutes after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||percentage of participants||95% Confidence Interval|Number
2632929|NCT01830855|Primary|Percentage of Participants Reporting at Least 1 Immediate AE After First Vaccination||Within 30 minutes after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.|||percentage of participants||95% Confidence Interval|Number
2632930|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
2632931|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event Within 30 Days After Any Vaccination||Within 30 Days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
2632932|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||percentage of participants||95% Confidence Interval|Number
2632933|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||percentage of participants||95% Confidence Interval|Number
2632934|NCT01830855|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) WIthin 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.|||percentage of participants||95% Confidence Interval|Number
2632935|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all participants who received at least 1 dose of the investigational product and had safety information available.|||percentage of participants||95% Confidence Interval|Number
2632936|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) for whom safety information was available from after post third-vaccination blood draw to 6 months after last study vaccination.|||percentage of participants||95% Confidence Interval|Number
2633392|NCT01825876|Secondary|PK: AUC0-∞ of R-Warfarin||Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose|All participants who received a dose of study drug and had evaluable data for AUC(0-∞).|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2632939|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||percentage of participants||95% Confidence Interval|Number
2632940|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination||30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||percentage of participants||95% Confidence Interval|Number
2632941|NCT01830855|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.|||percentage of participants||95% Confidence Interval|Number
2632942|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
2632943|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) for whom safety information was available from after post-vaccination 3 blood draw to 6 months after last study vaccination.|||percentage of participants||95% Confidence Interval|Number
2632944|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
2632945|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
2632946|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||percentage of participants||95% Confidence Interval|Number
2632947|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||percentage of participants||95% Confidence Interval|Number
2632948|NCT01830855|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.|||percentage of participants||95% Confidence Interval|Number
2632949|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
2632950|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose investigational product (rLP2086 or HAV/saline) for whom safety information was available from after post third-vaccination blood draw to 6 months after last study vaccination.|||percentage of participants||95% Confidence Interval|Number
2632951|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
2632952|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.|||percentage of participants||95% Confidence Interval|Number
2632953|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||percentage of participants||95% Confidence Interval|Number
2632954|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||percentage of participants||95% Confidence Interval|Number
2632955|NCT01830855|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.|||percentage of participants||95% Confidence Interval|Number
2632956|NCT01830855|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination|Here, N signifies participants with known values reporting specific characteristic.|Within 7 Days after third vaccination|Safety population for third vaccination included all participants who received third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw. Here, number of participants analyzed signifies participants with known values after third vaccination.|||percentage of participants||95% Confidence Interval|Number
2632957|NCT01830855|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination|Here, N signifies participants with known values reporting specific characteristic.|Within 7 Days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline), for whom safety information was available from second vaccination until prior to third vaccination.Here,number of participants analyzed signifies participants with known values after second vaccination.|||percentage of participants||95% Confidence Interval|Number
2632958|NCT01830855|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination|Here, N signifies participants with known values reporting specific characteristic.|Within 7 Days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination.Here,number of participants analyzed signifies participants with known values after the first vaccination.|||percentage of participants||95% Confidence Interval|Number
2632959|NCT01830855|Primary|Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination||Within 7 Days after third vaccination|Safety population for third vaccination included all participants who received third dose of investigational product (rLP2086 or HAV) and for whom safety information was available from third vaccination until post third-vaccination blood draw.Here,number of participants analyzed signifies participants with known values after third vaccination.|||percentage of participants||95% Confidence Interval|Number
2632960|NCT01830855|Primary|Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination||Within 7 Days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline), for whom safety information was available from second vaccination until prior to third vaccination.Here,number of participants analyzed signifies participants with known values after second vaccination.|||percentage of participants||95% Confidence Interval|Number
2632961|NCT01830855|Primary|Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination||Within 7 Days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or HAV) and for whom safety information was available from first vaccination until prior to second vaccination. Here,number of participants analyzed signifies participants with known values after the first vaccination.|||percentage of participants||95% Confidence Interval|Number
2632962|NCT01830855|Primary|hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine||One month after third bivalent rLP2086 vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain.|||titer||95% Confidence Interval|Geometric Mean
2632963|NCT01830855|Primary|Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1|Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1,2,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point.|One month after third bivalent rLP2086 vaccination|Evaluable immunogenicity population: all eligible participants randomized, who received correct investigational product, had pre/post vaccination blood drawn at pre-specified time points, had valid and determinate assay results for proposed analysis, received no prohibited treatment or prohibited vaccines, and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2632964|NCT01830842|Primary|Change in Blood Oxygen Level Dependent (BOLD) Signal in Dorsomedial Prefrontal Cortex|The acute and chronic effects of nicotine on the blood oxygen level dependent signal will be measured using functional magnetic resonance imaging. Reward-cue related BOLD signal on an outcome expectation task.|Nonsmokers: post nicotine and post placebo. Smokers: 24 hours smoking abstinence or smoking satiety|Subjects who did not follow MRI task instructions, or those with > 3 mm of movement, were excluded from the analyses.|||percentage of BOLD signal||Standard Deviation|Mean
2632976|NCT01830621|Secondary|Change of Global Quality of Life at 8 Weeks From Baseline|Change scores from baseline at time 2 (8 weeks) from baseline for the global health status/quality of life scale scores (between 0 and 100 with higher value indicating better quality of life) as derived from responses of patients to the EORTC (European Organisation for Research and Treatment of Cancer) quality of life questionnaire (QLQ-C30).|8 weeks|Patients who were assessed Quality of Life at baseline and week 8 from randomization.|||units on a scale||Standard Deviation|Mean
2632977|NCT01830621|Secondary|Number of Patients With Adverse Events|Number of patients with at least one adverse event as assessed by NCI CTCAE Version 3.0 criteria.|38 months|All patients who have received at least one dose of BBI608/Placebo.|||Participants|||Count of Participants
2639588|NCT01763905|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2632965|NCT01830816|Secondary|Duration of Response (DOR) in RRMM Participants|DOR was defined as time from date of first documentation of a PR or better to date of first documentation of progressive disease (PD) for responders. Increase of >25% from lowest response value in any one or more of following: Serum M-component and/or (absolute increase must be >0.5 g/dL); Urine M-component and/or (the absolute increase must be >200 mg/24 h); difference between involved and uninvolved free light chain (FLC) levels and the absolute increase must be > 10 mg/dL; Bone marrow plasma cell percentage; absolute percentage must be > 5%; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcaemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. Responders without PD were censored at the date of the last response assessment that was stable disease (SD) or better.|Day 1 of every other cycle from cycle 1 (each cycle of 28 days) up to progression of disease (approximately up to 855 days)|Response evaluable population is defined as participants who received at least 1 cycle of Ixazomib treatment in Part B and at least 1 post-baseline response assessment. Here, number of participants analyzed is the participants who had confirmed response.|||days||Full Range|Median
2632966|NCT01830816|Secondary|Percentage of Participants With Overall Response (OR) in Relapsed/Refractory Multiple Myeloma (RRMM) Participants|Overall response rate defined as percentage of relapsed/refractory multiple myeloma participants who achieved partial response (PR), complete response (CR) and very good partial response (VGPR) according to International Myeloma Working Group Criteria. PR=>50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or <200 mg/24 h. If serum and urine M-protein are unmeasurable, >50% decrease in difference between involved and uninvolved free light chain levels in place of M-protein criteria. If serum and urine M-protein and serum free light assay are not measurable, >50% reduction in plasma cells in place of M-protein, provided baseline bone marrow plasma cell >0%; CR=negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow; VGPR=serum and urine M-protein detectable by immunofixation but not on electrophoresis or > 90% reduction in serum M-protein plus urine M-protein level <100 mg/24 h.|Day 1 of every other cycle from cycle 1 (each cycle of 28 days) up to progression of disease (approximately up to 855 days)|Response evaluable is defined as participants who received at least 1 cycle of ixazomib treatment in Part B and at least 1 post-baseline response assessment.|||percentage of participants||95% Confidence Interval|Number
2632967|NCT01830816|Secondary|Number of Participants With Adverse Events|Adverse Event is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)|Safety population is defined as participants who received at least 1 dose of study drug.|||participants|||Number
2632968|NCT01830816|Primary|Unbound AUClast: Unbound Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib||Part A, Day 1: Predose and at multiple timepoints (up to 336 hours) post-dose|PK evaluable population was defined as participants who received protocol-specified single dose in Part A; did not receive any excluded concomitant medications through the completion of PK sampling; and had sufficient concentration-time data to permit reliable estimation of PK parameters by non-compartmental analysis methods.|||hr*ng/mL||Standard Deviation|Geometric Mean
2632969|NCT01830816|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib||Part A, Day 1: Predose and at multiple timepoints (up to 336 hours) post-dose|PK evaluable population was defined as participants who received protocol-specified single dose in Part A; did not receive any excluded concomitant medications through the completion of PK sampling; and had sufficient concentration-time data to permit reliable estimation of PK parameters by non-compartmental analysis methods.|||hours||Full Range|Median
2632970|NCT01830816|Primary|Unbound Cmax: Unbound Maximum Observed Plasma Concentration for Ixazomib||Part A, Day 1: Predose and at multiple timepoints (up to 336 hours) post-dose|Pharmacokinetic (PK) evaluable population was defined as participants who received protocol-specified single dose in Part A; did not receive any excluded concomitant medications through the completion of PK sampling; and had sufficient concentration-time data to permit reliable estimation of PK parameters by non-compartmental analysis methods.|||ng/mL||Standard Deviation|Geometric Mean
2632971|NCT01830790|Secondary|Change in Central Foveal Thickness as Assessed by Optical Coherence Tomography (OCT)||Baseline, 1hour, and 3 hours post-treatment|Study was terminated early due to inadequate support to complete recruitment/data analysis. No outcome measure data was collected.||||||
2632972|NCT01830790|Primary|Change in Choroidal Thickness as Assessed on Enhanced-Depth Imaging Optical Coherence Tomography (EDI-OCT)||Baseline, 1 hour, and 3 hours post-treatment|Study was terminated early due to inadequate support to complete recruitment/data analysis. No outcome measure data was collected.||||||
2632973|NCT01830699|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Any adverse event reported by the study participant during the four time points studied in the trial in either arm will be recorded.|4 weeks||||participants|||Number
2632974|NCT01830699|Secondary|Improvement in Pain|Secondary outcomes are improvement in pain (as assessed by patient self report, range between 0 and 10, with 0 as no pain and 10 described as the worst pain in their life).|4 weeks||||units on a scale||Standard Deviation|Mean
2632975|NCT01830699|Primary|Improvement in Shoulder Function|The QuickDASH will be used as the primary outcome to assess improvement in pain and function of patients with clinical symptoms and signs of subacromial bursitis randomized to either rilonacept vs. corticosteroid injection. The QuickDASH is an 11 question form, a short version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). It ranges from 0 (no symptoms/full function) to 100 (maximal symptoms/no function). No units are specified. Cutoff scores: < 15 = no problem, 16 - 40 = problem, but working, > 40 = unable to work. US population mean +/- SD is 10.1 +/- 14.7.|4 weeks||||units on a scale||Standard Deviation|Mean
2635094|NCT01807624|Primary|Cmax of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||ng/mL||Standard Deviation|Mean
2632978|NCT01830621|Secondary|Disease Control Rate|Proportion of all randomized patients with a documented complete response (CR) defined as disappearance of all target lesions, partial response (PR) defined as >=30% decrease in the sum of the longest diameter of target lesions, and stable disease (SD) defined as <30% decrease but also <20% increase in the sum of the longest diameter of target lesions without new lesions per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1 for target lesion.|38 months|All patients randomized to this study|||Participants|||Count of Participants
2632979|NCT01830621|Secondary|Progression Free Survival|Defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.|38 months|All patients randomized to this study|||Months||95% Confidence Interval|Median
2632980|NCT01830621|Primary|Overall Survival|Time from the day of randomization to death. For alive patients, overall survival was censored at the last day the patient was known alive (LKA).|38 month|All patients who were randomized to this study.|||Months||95% Confidence Interval|Median
2632981|NCT01830595|Other Pre-specified|sCD163|The change in blood levels of sCD163 will be compared between active and placebo treatment phases. During both the active and placebo treatment phase, all relevant time points are used in calculation of change (i.e., baseline, month 1 and month 3 for phase 1; and similarly months 5, 6 and 8 for phase 2).|3 months|45 participants contributed data during phase two. Participants had to attend the first visit (baseline or month 5) and also one follow-up visit in order to contribute data to the analyses.|||mg/L||Standard Deviation|Mean
2632982|NCT01830595|Other Pre-specified|Activated Monocyte Phenotype (CD16+)|The change in CD16+ monocyte subsets will be compared between active and placebo treatment phases. During both the active and placebo treatment phase, all relevant time points are used in calculation of change (i.e., baseline, month 1 and month 3 for phase 1; and similarly months 5, 6 and 8 for phase 2).|3 months|45 participants contributed data during phase two. Participants had to attend the first visit (baseline or month 5) and also one follow-up visit in order to contribute data to the analyses. Fewer participants had pre-drug and post-drug cells collected so numbers are less than 45 for this measure.|||percent of total monocyte population||Standard Deviation|Mean
2632983|NCT01830595|Primary|Number of Participants Taking Medication as Assigned|Number of participants taking medication as assigned at 3 months|3 months||||Participants|||Count of Participants
2632984|NCT01830595|Primary|IL-6 & D-dimer Score Changes From Baseline to 3 Months (or Month 5 to Month 8)|"The IL-6 & D-dimer score is defined as: 0. 33*log2 IL-6 + 0.16*log2 D-dimer, where IL-6 is measured in pg/mL and D-dimer in ug/mL. Since the biomarkers are on the log2 scale, associations of risk with the IL-6 & D-dimer score are interpreted as HR(event) per doubling of IL-6 and D-dimer, or HR(event) per 20% increase in IL-6 and D-dimer; the score itself is unitless.~Among the 3766 study participants for whom the score was developed, the min was -1.7, the max was 2.5.~Higher scores are worse."|3 months (Baseline to Month 3 or Month 5 to Month 8)|45 participants contributed data during phase two. Participants had to attend the first visit (baseline or month 5) and also one follow-up visit in order to contribute data to the analyses.|||score on a scale||Standard Deviation|Mean
2632985|NCT01830595|Primary|Number of Participants With at Least One Side Effect, Adverse Event, and Serious Adverse Event|Self reported side effects and/or Division of AIDS (DAIDS) criteria will be used for grading adverse events (serious and non-serious)|During 3 months on Lactoferrin or Placebo (and following washout period)||||Participants|||Count of Participants
2632986|NCT01830543|Secondary|Percentage of Participants With Stent Thrombosis|The percentage of participants with the first occurrence of stent thrombosis were evaluated.|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.|||percentage of participants|||Number
2632987|NCT01830543|Secondary|Percentage of Participants With Stroke|The percentage of participants with the first occurrence of Stroke were evaluated.|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.|||percentage of participants|||Number
2632988|NCT01830543|Secondary|Percentage of Participants With Myocardial Infarction|The percentage of participants with the first occurrence of Myocardial Infarction were evaluated.|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.|||percentage of participants|||Number
2632989|NCT01830543|Secondary|Percentage of Participants With Cardiovascular Death|The percentage of participants with the first occurrence of cardiovascular death were evaluated.|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.|||percentage of participants|||Number
2632990|NCT01830543|Secondary|Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)|Percentage of participants who experienced adverse cardiovascular events (cardiovascular death, myocardial Infarction (MI) and stroke) collectively, were assessed.|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.|||percentage of participants|||Number
2632991|NCT01830543|Secondary|Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)|A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'n' signifies number of participants analyzed at specific time-point in this outcome measure.|||percentage of participants|||Number
2632992|NCT01830543|Secondary|Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding|TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to <5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent).|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'n' signifies number of participants analyzed at specific time-point in this outcome measure.|||percentage of participants|||Number
2632993|NCT01830543|Secondary|Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding|TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, Clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of >= 5 g/dL (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent).|Up to Month 12 and end of DAPT-Month 1, 6 and 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.|||percentage of participants|||Number
2632994|NCT01830543|Primary|Percentage of Participants With Clinically Significant Bleeding|Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA). TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of greater than or equal to (>=) 5 grams per deciliter (g/dL) (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent (%)). TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to less than (<) 5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent). A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.|Up to Month 12|The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2632995|NCT01830205|Secondary|Number of Participants With Out-of-range Vital Signs Reported as Adverse Events|The total number of participants with abnormal range vital signs which were considered as adverse events was determined.|Baseline up to Day 5 post dose|Analysis was done in safety data set population.|||Participants|||Number
2632996|NCT01830205|Secondary|Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Reported as Adverse Events|The number of participants with clinically relevant changes in ECG which were considered as adverse events was determined.|Baseline up to Day 5 post dose|Analysis was done in safety data set population.|||Participants|||Number
2632997|NCT01830205|Secondary|Number of Participants With Clinically Significant Laboratory Marked Abnormalities Reported as Adverse Events|Significant laboratory abnormalities were defined as any test results which were observed beyond the clinically acceptable limits as per the discretion of investigator.|Baseline up to Day 5 post dose|The analysis was done in safety population.|||Participants|||Number
2632998|NCT01830205|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events and Who Died|Adverse event (AE) was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation.|First dose up to Day 5 post last dose for AEs; up to 30 days post last dose for SAEs|Analysis was done in safety data set population, defined as all the participants who received the study medication.|||Participants|||Number
2632999|NCT01830205|Secondary|Apparent Volume of Distribution (Vd/F) of Daclatasvir|The Vd/F was calculated by dividing the product of the dose and mean residence time by area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2633000|NCT01830205|Secondary|Renal Clearance (CLR) of Daclatasvir|The CLR was calculated by dividing the total amount excreted in the urine from 0 to 96 hours by the area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=3), moderate (n=5) and severe renal impairment (n=5). Mild participants (n=4) are also counted as per their original allocation.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2633001|NCT01830205|Secondary|Percent Urinary Recovery (%UR) of Daclatasvir|The percentage of daclatasvir recovered in the urine was determined by using validated liquid chromatography-tandem mass spectrometry methods. The sum of the percentage of dose recovered in urine from all intervals was calculated to obtain the total percentage of urinary excretion.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=3), moderate (n=5) and severe renal impairment (n=5). Mild participants (n=4) are also counted as per their original allocation.|||Percentage of daclatasvir recovered||Geometric Coefficient of Variation|Geometric Mean
2633002|NCT01830205|Secondary|Unbound Apparent Clearance (CLU/F) of Daclatasvir|The CLU/F was calculated by dividing the apparent total body clearance by mean fraction of unbound drug from 1 hour post dose time point.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2633003|NCT01830205|Secondary|Apparent Total Body Clearance (CLT/F) of Daclatasvir|Apparent total body clearance was calculated by dividing the dose by area under the plasma concentration-time curve from time zero extrapolated to infinite time.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||milliliter/minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
2633004|NCT01830205|Secondary|Plasma Half-life (T-half) of Daclatasvir|Terminal half-life was the time required for one half of the total amount of administered drug eliminated from the body.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||hours||Geometric Coefficient of Variation|Geometric Mean
2633005|NCT01830205|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Daclatasvir|Tmax was defined as the time required to reach maximum observed plasma concentration. Tmax was directly determined from the raw plasma concentration-time data.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||hours||Full Range|Median
2633006|NCT01830205|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Last Measurable Concentration [AUC(0-T)] of Daclatasvir|AUC(0-T) was calculated as the sum of linear trapezoids using non-compartmental analysis.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||ng*hour (h)/mL||Geometric Coefficient of Variation|Geometric Mean
2633007|NCT01830205|Secondary|Unbound Maximum Observed Plasma Concentrations of Daclatasvir|Unbound Maximum observed plasma concentrations (Cmaxu) was calculated by multiplying maximum observed plasma concentrations by mean fraction of unbound drug from 1 hour post-dose time point.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2633008|NCT01830205|Secondary|Maximum Observed Plasma Concentration (Cmax) of Daclatasvir|Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data. The plasma samples were analyzed for daclatasvir by using a validated liquid chromatography tandem mass spectrometric (LC-MS/MS) assay.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2633009|NCT01830205|Secondary|Unbound Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity Time (AUC(INF)u) of Daclatasvir|AUC(INF)u was calculated by multiplying the area under the plasma concentration-time curve from time zero extrapolated to infinite time by mean fraction of unbound drug from 1 hour post-dose time point.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|Pharmacokinetic (PK) data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2633010|NCT01830205|Primary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Daclatasvir|AUC(INF) was estimated by summing the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and the extrapolated area, computed by the quotient of the last observable concentration and elimination rate constant. The pharmacokinetic (PK) analysis was based on Cockcroft-Gault (C-G) creatinine clearance (CLcr) grouping method: normal renal function, end stage renal disease (ESRD), moderate and severe renal impairment. Mild participants were counted as per their original allocation.|Pre-dose (0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose|PK data set included all participants who received at least 1 dose of daclatasvir with adequate PK profiles. The PK analysis was based on the C-G CLcr grouping method: normal renal function (n=11), ESRD (n=10), moderate (n=5) and severe renal impairment (n=6). Mild participants (n=4) are also counted as per their original allocation.|||nanograms*hours/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2633011|NCT01830140|Primary|Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye|Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye.|Baseline, 6 Weeks|Intent-to-Treat: all randomized patients|||Percentage of Patients|||Number
2633012|NCT01830127|Secondary|SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT)|Sustained virologic response (SVR) at Week 4 post-treatment (SVR4): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL at 4 weeks after EOT. SVR4 was analyzed in a descriptive manner using percentage.|4 weeks after End of Treatment|(Treated Set) All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomization.|||Percentage of participants||95% Confidence Interval|Number
2633013|NCT01830127|Primary|SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)|Sustained virologic response (SVR) at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) at 12 weeks after EOT. SVR12 was analyzed in a descriptive manner using percentage.|12 weeks after End of Treatment|(Treated Set) All patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, regardless of randomization.|||Percentage of participants||95% Confidence Interval|Number
2633014|NCT01829997|Secondary|Satisfaction With Surgery|Overall satisfaction with the procedure|12 months||||Participants|||Count of Participants
2633015|NCT01829997|Secondary|Returning to Work|Time frame in which patient returned to work after surgery|12 Months|Data was not collected||||||
2633016|NCT01829997|Secondary|Number of Participants With Decreased Usage of Pain Medication|Number of participants with decreased usage of pain medication after surgery|12 months|Data was not collected||||||
2633017|NCT01829997|Secondary|Number of Participants With Improvement in Pain Scores|Number of participants with improvement in pain scores after surgery using the Visual Analog Scale. The scale measured from (0) no pain to (10) unbearable pain.|12 months||||Participants|||Count of Participants
2633018|NCT01829997|Secondary|Number of Participants With Improvement in Quality of Life|Number of participants with improvement in quality of life after surgery using the RAND-36 (a short form health survey). It is a 36 set of easily administered quality of life measures answered by the patient.|12 months||||Participants|||Count of Participants
2633019|NCT01829997|Primary|Number of Patients With Fusion|Fusion is defined as the presence of bridging trabecular bone and less than 3mm of translational motion and less than 5mm of angular motion.|12 months||||Participants|||Count of Participants
2633020|NCT01829919|Primary|Ct (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"C(t) is the measured plasma level Concentration of the drug at time = t expressed as nanograms per milliliter."|Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||ng/mL||Standard Deviation|Mean
2633021|NCT01829919|Primary|Cavg,ss (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||ng/mL||Standard Deviation|Mean
2633022|NCT01829919|Primary|Fluctuation Index (%) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|Fluctuation Index is (Cmax-Cmin)/Cavg,ss. It is peak trough fluctuation within one dosing interval at steady state.|Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||Percentage of steady state concentration||Full Range|Mean
2633023|NCT01829919|Primary|Accumulation Index Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg at Day 19|Accumulation Index is the ratio of AUC 0-24 after multiple doses versus a single dose. It is the increase in drug plasma concentration after multiple dosing until a steady state is reached. In this case the steady state Accumulation Index was calculated at Day 19. Accumulation Index is calculated at the end of the dosing period.|Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||Ratio||Full Range|Mean
2633024|NCT01829919|Primary|Tmax (Hour) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||Hours||Full Range|Mean
2633025|NCT01829919|Primary|Cmin (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||ng/mL||Standard Deviation|Mean
2633026|NCT01829919|Primary|Cmax (ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||ng/mL||Standard Deviation|Mean
2633027|NCT01829919|Primary|AUC (Hour*ng/mL) Multiple Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 19|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||Hour*ng/mL||Standard Deviation|Mean
2633028|NCT01829919|Primary|Median t1/2 Single Dose Pharmacokinetics of Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||hours||Full Range|Median
2633029|NCT01829919|Primary|Mean t1/2 Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||Hours||Standard Deviation|Mean
2633030|NCT01829919|Primary|Kel (Hour^-1) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||Hour^(-1)||Standard Deviation|Mean
2633031|NCT01829919|Primary|Cmax (ng/mL) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||ng/mL||Standard Deviation|Mean
2633032|NCT01829919|Primary|AUC (Hour*ng/mL) Single Dose Pharmacokinetics of Brisdelle™ (Paroxetine Mesylate) Capsules 7.5 mg||Day 1|Safety and evaluable pharmacokinetic populations = 24 randomized subjects.|||Hour*ng/mL||Standard Deviation|Mean
2633033|NCT01829711|Secondary|Percentage of Participants With Positive Anti-drug Antibodies (ADA), Neutralizing Anti-drug Antibodies (nAb) and Specificity (CD22 and PE38) Positive to Moxetumomab Pasudotox|Participants with ADA positive, nAb positive, cluster of differentiation 22 (CD22) positive of ADA positive/NAb positive, and pseudomonas exotoxin 38 (PE38) positive of ADA positive/NAb positive to moxetumomab pasudotox at any visit are reported.|Pre-infusion on Day 1 of Cycles 1, 2, 3, and 5; at the End of Treatment (4 to 6 weeks after the last dose; approximately 7 months)|Safety population included participants who received at least 1 dose of moxetumomab pasudotox.|||Percentage of Participants|||Number
2633034|NCT01829711|Secondary|Terminal Half Life (t1/2) of Moxetumomab Pasudotox|The t1/2 of moxetumomab pasudotox is reported.|Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)|The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point. Data for Cycle 1 Day 1 was not reported as no evaluable participants for the calculation of the concerned parameters (ie., data were not sufficient).|||Hours||Standard Deviation|Mean
2633035|NCT01829711|Secondary|Systemic Clearance (CL) of Moxetumomab Pasudotox|The CL of moxetumomab pasudotox is reported.|Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)|The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point. Data for Cycle 1 Day 1 was not reported as no evaluable participants for the calculation of the concerned parameters (ie., data were not sufficient).|||mL/hr/kg||Standard Deviation|Mean
2633036|NCT01829711|Secondary|Area Under the Plasma Concentration-time Curve Extrapolated (AUCExt) of Moxetumomab Pasudotox|The AUCExt of moxetumomab pasudotox is reported.|Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)|The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point.|||ng*hr/mL||Standard Deviation|Mean
2633037|NCT01829711|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Moxetumomab Pasudotox|The AUC0-inf of moxetumomab pasudotox is reported.|Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)|The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point. Data for Cycle 1 Day 1 was not reported as no evaluable participants for the calculation of the concerned parameters (ie., data were not sufficient).|||ng*hr/mL||Standard Deviation|Mean
2633038|NCT01829711|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to 3 Hours (AUC0-3hr) Post End of Moxetumomab Pasudotox|The AUC0-3hr of moxetumomab pasudotox is reported.|Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, and 3 hr post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)|The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point.|||ng*hr/mL||Standard Deviation|Mean
2633039|NCT01829711|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC0-last) of Moxetumomab Pasudotox|The AUC0-last of moxetumomab pasudotox is reported.|Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)|The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point.|||ng*hr/mL||Standard Deviation|Mean
2633040|NCT01829711|Secondary|Time of Last (Tlast) Measurable Concentration of Moxetumomab Pasudotox|The Tlast of moxetumomab pasudotox is reported.|Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)|The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point.|||Hours||Standard Deviation|Mean
2633041|NCT01829711|Secondary|Maximum Observed Plasma Concentration (Cmax) of Moxetumomab Pasudotox|The Cmax of moxetumomab pasudotox is reported.|Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)|The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point.|||ng/mL||Standard Deviation|Mean
2633042|NCT01829711|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Moxetumomab Pasudotox|The Tmax of moxetumomab pasudotox is reported.|Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)|Pharmacokinetic (PK) population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point.|||Hours||Full Range|Median
2633043|NCT01829711|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs|An abnormal ECG findings that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 30 days after the last dose of study drug (approximately 7 months).|From the start of study treatment (Day 1) through 4-6 weeks after last dose of Cycle 6 (28-day cycle) (approximately 7 months)|Safety population included participants who received at least 1 dose of moxetumomab pasudotox.|||Participants|||Count of Participants
2633044|NCT01829711|Secondary|Number of Participants With Abnormal Vital Signs Reported as TEAEs|An abnormal vital signs that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 30 days after the last dose of study drug (approximately 7 months).|From the start of study treatment (Day 1) through 4-6 weeks after last dose of Cycle 6 (28-day cycle) (approximately 7 months)|Safety population included participants who received at least 1 dose of moxetumomab pasudotox.|||Participants|||Count of Participants
2633045|NCT01829711|Secondary|Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 30 days after the last dose of study drug (approximately 7 months).|From the start of study treatment (Day 1) through 4-6 weeks after last dose of Cycle 6 (28-day cycle) (approximately 7 months)|Safety population included participants who received at least 1 dose of moxetumomab pasudotox.|||Participants|||Count of Participants
2633068|NCT01829503|Secondary|Overall Survival (OS) in Participants Who Experienced Complete Response or Complete Response With Incomplete Count Recovery||Up to 38 months (median follow-up = 25.4 months)|Evaluable participants who experienced a Clinical Response (CR) of Complete Response, or Complete Response with Incomplete Count Recovery.|||months||90% Confidence Interval|Median
2633046|NCT01829711|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug.|From the start of study treatment (Day 1) through 4-6 weeks after last dose of Cycle 6 (28-day cycle) (approximately 7 months)|Safety population included participants who received at least 1 dose of moxetumomab pasudotox.|||Participants|||Count of Participants
2633047|NCT01829711|Secondary|Time to Treatment Failure (TTF) Assessed by Blinded Independent Central Review|The TTF was defined as the time from the start of moxetumomab pasudotox administration to the date of the first of relapse, progressive disease, initiation of alternative anticancer therapy, or death due to disease or disease-related complication. The TTF was censored on the date of last disease assessment or hematologic assessment for participants who are alive with no documented relapse or PD prior to data cut-off, dropout, or the initiation of alternative anticancer therapy and also censored for death not accompanied by relapse.|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 6 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox.|||Months||95% Confidence Interval|Median
2633048|NCT01829711|Secondary|Progression-free Survival (PFS) Assessed by Blinded Independent Central Review|The PFS was defined as the time from the start of moxetumomab pasudotox administration to the earliest date of a disease assessment showing a progressive disease/relapse, earliest date of hematologic relapse or date of death, whichever was earlier. The PFS was censored on the date of last disease assessment or hematologic assessment for participants who are alive with no documented relapse or PD prior to data cut-off, dropout, or the initiation of alternative anticancer therapy.|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 6 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox.|||Months||95% Confidence Interval|Median
2633049|NCT01829711|Secondary|Duration of Objective Response Assessed by Blinded Independent Central Review|"Duration of OR was defined as the time from the first documentation of objective response (CR or PR) to the date of relapse.~Duration of OR was censored on the date of last disease assessment or hematologic assessment for participants who have no documented relapse prior to data cut-off, dropout, or the initiation of alternative anticancer therapy."|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 6 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox. Duration of OR was evaluated for participants who achieved OR per independent central review.|||Months||95% Confidence Interval|Median
2633050|NCT01829711|Secondary|Time to Objective Response Assessed by Blinded Independent Central Review|Time to OR was defined as the time from the start of moxetumomab pasudotox administration to the first documentation of OR (CR or PR).|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 6 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox. Time to OR was evaluated for participants who achieved OR per independent central review.|||Months||Full Range|Median
2633051|NCT01829711|Secondary|Percentage of Participants With Objective Response by Investigator's Assessment|The OR was defined as number of participants with a best response of CR or PR. CR requires all of following to be present: No evidence of leukemic cells in peripheral blood and/or by routine H/E staining of bone marrow; Resolution of any hepatomegaly, splenomegaly, and abnormal (>=2 cm minimum length) lymphadenopathy by CT or MRI (maximum diameter of spleen should be either <17 cm or have decreased by >25% from its baseline); normal CBC (Neutrophils >=1.5 x 10^9/L, Platelets >=100 x 10^9/L, and hemoglobin >=11.0 g/dL) without transfusions or growth factors for at least 4 weeks. PR requires all of following for a period of at least 4 weeks: >=50% decrease or normalization (<5.0 x 10^9/L) in peripheral blood lymphocyte count and >=50% reduction in lymphadenopathy and in abnormal haepatosplenomegaly by CT or MRI from pre-treatment baseline value; normal CBC as mentioned above or 50% improvement in CBC values over baseline without transfusions or growth factors for at least 4 weeks.|Prior to each treatment cycle, end of treatment, and at follow-up visits every 3 months for the next 24 months and every 6 months thereafter (Approximately 6 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox.|||Percentage of participants||95% Confidence Interval|Number
2633052|NCT01829711|Secondary|Percentage of Participants With Objective Response (OR) Assessed by Blinded Independent Central Review|The OR was defined as number of participants with a best response of CR or PR. CR requires all of following to be present: No evidence of leukemic cells in peripheral blood and/or by routine H/E staining of bone marrow; Resolution of any hepatomegaly, splenomegaly, and abnormal (>=2 cm minimum length) lymphadenopathy by CT or MRI (maximum diameter of spleen should be either <17 cm or have decreased by >25% from its baseline); normal CBC (Neutrophils >=1.5 x 10^9/L, Platelets >=100 x 10^9/L, and hemoglobin >=11.0 g/dL) without transfusions or growth factors for at least 4 weeks. PR requires all of following for a period of at least 4 weeks: >=50% decrease or normalization (<5.0 x 10^9/L) in peripheral blood lymphocyte count and >=50% reduction in lymphadenopathy and in abnormal haepatosplenomegaly by CT or MRI from pre-treatment baseline value; normal CBC as mentioned above or 50% improvement in CBC values over baseline without transfusions or growth factors for at least 4 weeks.|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 6 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox.|||Percentage of participants||95% Confidence Interval|Number
2633053|NCT01829711|Secondary|Time to Hematologic Remission|Time to HR was defined as the time from the start of moxetumomab pasudotox administration to the first documentation of HR. HR was defined as the blood counts required for CR as normal CBC as exhibited by: Neutrophils >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L, and hemoglobin >= 11.0 g/dL without transfusions or growth factors for at least 4 weeks.|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 6 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox. Time to HR was evaluated for participants in the ITT population who achieved HR.|||Months||Full Range|Median
2633054|NCT01829711|Secondary|Duration of Hematologic Remission|"Duration of HR was defined as the duration from documentation of HR to the time of relapse. HR was defined as the blood counts required for CR as normal CBC as exhibited by: Neutrophils >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L, and hemoglobin >= 11.0 g/dL without transfusions or growth factors for at least 4 weeks.~Duration of HR was censored on the date of the last hematologic assessment for participants who have no documented relapse based on blood count prior to data cutoff, dropout, or initiation of alternative anticancer therapy."|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 6 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox. Duration of HR was evaluated for participants who achieved HR.|||Months||95% Confidence Interval|Median
2633055|NCT01829711|Secondary|Duration of CR Assessed by Blinded Independent Central Review|Duration of CR was defined as the duration from documentation of CR to the time of relapse from CR. Relapse from CR was defined as any CR criteria (blood counts, imaging or bone marrow) no longer consistent with CR. CR requires all of the following to be present: No evidence of leukemic cells in peripheral blood and/or by routine H/E staining of bone marrow; Resolution of any hepatomegaly, splenomegaly, and abnormal (>= 2 cm minimum length) lymphadenopathy by CT or MRI (maximum diameter of spleen should be either < 17 cm or have decreased by >25% from its baseline); normal CBC as exhibited by: Neutrophils >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L, and hemoglobin >= 11.0 g/dL without transfusions or growth factors for at least 4 weeks.|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 6 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox. Duration of CR was evaluated for participants who achieved CR per independent central review.|||Months||95% Confidence Interval|Median
2633056|NCT01829711|Secondary|Time to CR Assessed by Blinded Independent Central Review|Time to CR was defined as the time from the start of moxetumomab pasudotox administration to the first documentation of CR.|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 6 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox. Time to CR was evaluated for participants who achieved CR per independent central review.|||Months||Full Range|Median
2633057|NCT01829711|Secondary|Percentage of Participants With MRD Positive or MRD Negative CR by Investigator's Assessment|"The MRD status by investigator refers to results of investigator assessment of bone marrow biopsy or bone marrow aspirate by immunohistochemistry and/or flow cytometry.~The CR with Positive or Negative MRD requires all of the following to be present:~No evidence of leukemic cells in the peripheral blood and/or by routine H/E staining of bone marrow. Minimal Residual Disease: CR with HCL evident in blood or marrow by flow cytometry.~Resolution of any hepatomegaly, splenomegaly, and abnormal (>= 2 cm minimum length) lymphadenopathy by CT or MRI. Although a normal spleen size is not defined, the maximum diameter of the spleen should be either < 17 cm or have decreased by >25% from its baseline.~Normal CBC as exhibited by: Neutrophils >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L, and hemoglobin >= 11.0 g/dL without transfusions or growth factors for at least 4 weeks."|Prior to each treatment cycle, end of treatment, and at follow-up visits every 3 months for the next 24 months and every 6 months thereafter (Approximately 6 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox.|||Percentage of participants||95% Confidence Interval|Number
2633058|NCT01829711|Secondary|Percentage of Participants With Minimal Residual Disease (MRD) Positive or MRD Negative CR Assessed by Blinded Independent Central Review|"The MRD status by blinded independent review refers specifically to results of central pathologist read of bone marrow biopsy by immunohistochemistry.~The CR with Positive or Negative MRD requires all of the following to be present:~No evidence of leukemic cells in the peripheral blood and/or by routine H/E staining of bone marrow. Minimal Residual Disease: CR with HCL evident in blood or in bone marrow biopsy by immunohistochemistry.~Resolution of any hepatomegaly, splenomegaly, and abnormal (>= 2 cm minimum length) lymphadenopathy by CT or MRI. Although a normal spleen size is not defined, the maximum diameter of the spleen should be either < 17 cm or have decreased by >25% from its baseline.~Normal CBC as exhibited by: Neutrophils >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L, and hemoglobin >= 11.0 g/dL without transfusions or growth factors for at least 4 weeks."|Prior to each treatment cycle, EOT (up to 24 weeks), monthly from the EOT assessment until the Day 181 assessment (only for CBC), at follow-up visits every 3 months for the next 24 months, and every 6 months thereafter (approximately 6 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox.|||Percentage of participants||95% Confidence Interval|Number
2633069|NCT01829503|Secondary|Overall Survival (OS) in Participants Who Experienced Complete Response||Up to 38 months (median follow-up = 25.4 months)|Evaluable participants who experienced a Clinical Response (CR) of Complete Response.|||months||90% Confidence Interval|Median
2633070|NCT01829503|Secondary|Overall Survival (OS)||Up to 38 months (median follow-up = 25.4 months)|All study participants.|||months||90% Confidence Interval|Median
2633071|NCT01829503|Secondary|Proportion of Participants With Survival to Four and Eight Weeks and One Year|The proportion of all participants experiencing four and eight-week mortality, or, who were alive at one year.|Up to one year (4 weeks, 8 weeks, and one year)|All study participants.|||Proportion of participants||90% Confidence Interval|Number
2639589|NCT01763905|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2633059|NCT01829711|Primary|Percentage of Participants With Durable CR by Investigator's Assessment|Durable CR was defined as overall response that meets blood, bone marrow and imaging criteria for CR, followed by a >180 day duration of HR. CR requires all of the following to be present: No evidence of leukemic cells in peripheral blood and/or by routine H/E staining of bone marrow; Resolution of any hepatomegaly, splenomegaly, and abnormal (>= 2 cm minimum length) lymphadenopathy by CT or MRI (maximum diameter of spleen should be either < 17 cm or have decreased by >25% from its baseline.); HR requires normal complete blood count (CBC) as exhibited by: Neutrophils >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L, and hemoglobin >= 11.0 g/dL without transfusions or growth factors for at least 4 weeks.|Full disease assessment (CBC, bone marrow and imaging) at end of treatment (EOT; up to 24 weeks) and post EOT Day 181; CBC monthly for 6 months post EOT, every 3 months post Day 181 for first 2 years and every 6 months thereafter (approximately 6 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox.|||Percentage of participants||95% Confidence Interval|Number
2633060|NCT01829711|Primary|Percentage of Participants With Durable Complete Response (CR) Assessed by Blinded Independent Central Review|Durable CR was defined as overall response that meets blood, bone marrow and imaging criteria for CR, followed by a >180 day duration of hematologic remission (HR). CR requires all of the following to be present: No evidence of leukemic cells in peripheral blood and/or by routine H/E staining of bone marrow; Resolution of any hepatomegaly, splenomegaly, and abnormal (>= 2 cm minimum length) lymphadenopathy by CT or MRI (maximum diameter of spleen should be either < 17 cm or have decreased by >25% from its baseline.); HR requires normal complete blood count (CBC) as exhibited by: Neutrophils >= 1.5 x 10^9/L, Platelets >= 100 x 10^9/L, and hemoglobin >= 11.0 g/dL without transfusions or growth factors for at least 4 weeks.|Full disease assessment (CBC, bone marrow and imaging) at end of treatment (EOT; up to 24 weeks) and post EOT Day 181; CBC monthly for 6 months post EOT, every 3 months post Day 181 for first 2 years and every 6 months thereafter (approximately 6 years)|The ITT population included participants who entered into the study and treated with moxetumomab pasudotox.|||Percentage of participants||95% Confidence Interval|Number
2633061|NCT01829516|Secondary|Average Percentage of Correct Responses on a Social Perception Task, Reading the Mind in the Eyes Test (RMET) After Administration of Oxytocin vs. Placebo During the 3-week Study.|We will examine the effects of intranasal oxytocin administration on overall RMET performance in moderate to heavy social alcohol drinkers after placebo or oxytocin administration. The RMET has 28 items. Each item is an cropped photo of a person's eyes with four emotion labels around it. The subjects are asked to select which one of the four emotion words best describes the emotion that the eyes are showing. RMET is scored by adding up the total number of correct responses (range 0-28). The mean percent correct is then calculated.|Administered at visits 2 and 3|1 subject did not complete the RMET task, so only 31 participant responses were analyzed for this task.|||Mean percent correct responses||Standard Error|Mean
2633062|NCT01829516|Primary|Change in Craving on the Alcohol Urge Questionnaire (AUQ) After Administration of Oxytocin vs. Placebo During the 3-week Study.|Change in craving represented by the mean difference in Alcohol Urge Questionnaire (AUQ) craving scores between alcohol and water cues (e.g., a positive alcohol-water score indicates cue-induced craving) after administration of oxytocin vs. placebo during the 3-week study. Craving for alcohol was assessed prior to the water and alcohol cues and again after each stimulus presentation using the 8-item Alcohol Urge Questionnaire (AUQ) (Bohn et al., 1995), in which subjects indicate how much they agree or disagree with statements regarding their alcohol craving on a 7-point Likert scale. AUQ craving scores are calculated by averaging responses to the 8 items. Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores and ranges from 1 to 7. Higher scores reflect greater craving.|Measured just prior to and after each of the water and alcohol cues at visits 2 and 3.|In this crossover study a total of 32 participants were analyzed for each intervention.|||units on a 7-pt Likert Scale||Standard Error|Mean
2633063|NCT01829503|Secondary|Functional Assessment of Cancer Therapy: Health-related Quality of Life (HRQOL) Measure|"The FACT-Leu Health-related Quality of Life (HRQOL) Measure is a 27-item FACT-G scale plus a 17-item leukemia sub-scale. The FACT-G contains uses Likert scale 0-4, with 0 =not at all and 4 =very much. The total score can be 0-108 and includes 7 items related Physical Well-being (PWB), 7 items related to Social Well-being (SWB), 6 items related to Emotional Well-being (EWB) and 7 items related to Functional Well-Being (FWB). Higher scores are better. Responses based on how patients felt in the past 7 days. FACT-Leu uses a Likert scale (0 to 4, with 0= not at all and 4= very much). The total score for the 17 items can be 0-68. Higher scores are better. The FACT-Leu total is the sum of FACT-G and FACT Leu and ranges from 0-176. Higher scores are better. FACT Trial Outcome Index is derived by adding scores on the PWB and FWB sub-scales to the leukemia sub-scales. The total for this index score is from 0-124. Higher scores are better."|Baseline to Post-treatment, up to 5 years|Participants that received at least one cycle of treatment.|||units on a scale||Standard Error|Mean
2633064|NCT01829503|Secondary|Relapse-Free Survival in Participants With Complete Response, Complete Response With Incomplete Count Recovery or Partial Response, and Received Maintenance Therapy||Up to 38 months|Evaluable participants who experienced a Clinical Response (CR) of Complete Response, Complete Response with Incomplete Count Recovery, or Partial Response.|||months||90% Confidence Interval|Median
2633065|NCT01829503|Secondary|Relapse-Free Survival in Participants With Complete Response or Complete Response With Incomplete Count Recovery.||Up to 38 months|Evaluable participants who experienced a Clinical Response (CR) of Complete Response or Complete Response with Incomplete Count Recovery.|||months||90% Confidence Interval|Median
2633066|NCT01829503|Secondary|Demographic Characteristics and Clinical Measures as Potential Predictors of Overall Survival (OS)|Median number of months of survival per individual demographic characteristics and clinical measures.|Up to 38 months (median follow-up = 25.4 months)|All study participants.|||months||95% Confidence Interval|Median
2633067|NCT01829503|Secondary|Overall Survival (OS) in Participants Who Experienced Complete Response, Complete Response With Incomplete Count Recovery, or Partial Response||Up to 38 months (median follow-up = 25.4 months)|Evaluable participants who experienced a Clinical Response (CR) of Complete Response, Complete Response with Incomplete Count Recovery, or, Partial Response.|||months||90% Confidence Interval|Median
2635252|NCT01806506|Secondary|Plasma IGF-1 at 12 Months|Insulin like growth factor 1 (IGF-1) is similar in structure to insulin. It has anabolic effects. Its levels may be related to BMI and level of nutrition.|12 months after surgery|||||||
2633073|NCT01829503|Primary|Proportion of Participants With Clinical Response (CR)|The number of participants (out of 39) who experienced Clinical Response as Complete Response, or, Complete Response + Complete Response with Incomplete Count Recovery (exact Clopper-Pearson confidence interval).|Up to 38 months|Evaluable participants with known Clinical Response (CR) (Complete Response, Complete Response with Incomplete Count Recovery, or Partial Response), and participants who had Progressive Disease.|||Proportion of participants||90% Confidence Interval|Number
2633074|NCT01829503|Primary|Number of Participants by Best Clinical Response Experienced|The number of participants who experienced either a Complete Response, Complete Response with Incomplete Count Recovery, Partial Response, or Progressive Disease. Complete response: Less than 5% blasts in an aspirate sample of a patient who has an absolute neutrophil count of >1000µ/L and platelets >100,000µ/L; Complete response with incomplete count recovery: Complete response except for residual neutropenia (<1000µ/L) or thrombocytopenia (<100,000µ/L) Partial response: Decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate; Progressive disease: Failure to achieve complete response or partial response|Up to 38 months|Evaluable participants with known Clinical Response.|||Participants|||Number
2633075|NCT01829477|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|The change between the fasting plasma glucose value collected at week 24 or final visit relative to baseline.|Baseline and Week 24|In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.||||||
2633076|NCT01829477|Secondary|Percentage of Participants With HbA1c <7 % at Week 24.||Week 24|In accordance with the SAP, due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.||||||
2633077|NCT01829477|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 relative to baseline.|Baseline and Week 24|In accordance with the Statistical Analysis Plan (SAP), due to the limited enrollment at the time of study termination, the summaries and statistical analyses of primary and secondary efficacy parameters originally intended and described in the protocol were not produced.||||||
2633078|NCT01829464|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|The change between the fasting plasma glucose values collected at Week 24 relative to baseline.|Baseline and Week 24|FAS included all randomized participants who received at least 1 dose of double blind study medication and who had a baseline and at least 1 post-baseline assessment.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2633079|NCT01829464|Secondary|Percentage of Participants With HbA1c <7%||Week 24|Due to the relatively limited enrollment and follow-up at the time of study termination, the analysis of percentage of participants with HbA1c <7% at Week 24 was not performed.||||||
2633080|NCT01829464|Primary|Change From Baseline in HbA1c at Week 24|The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to baseline.|Baseline and Week 24|Full analysis set (FAS) included all randomized participants who received at least 1 dose of double blind study medication and who had a baseline and at least 1 post-baseline assessment.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
2633081|NCT01829425|Secondary|Voids on Bladder Diary|number of voids on 3-day bladder diary|12 months|At 12 months, of the 74 randomized to hypnotherapy: 4 had withdrawn and 1 was missing diary information. Of the 78 women randomized to medications, 7 had withdrawn.|||counts||95% Confidence Interval|Mean
2633082|NCT01829425|Secondary|Voids on Bladder Diary|number of voids on 3-day bladder diary|6 months|Of the 74 women randomized to hypnotherapy, at 6 months: 4 had withdrawn and 2 were lost and 1 was missing diary information. Of the 78 women randomized to medications, 6 had withdrawn and 1 was lost.|||counts||95% Confidence Interval|Mean
2633083|NCT01829425|Secondary|Voids on Bladder Diary|Total Number of voids on 3-day bladder diary.|2 months|At 2 months in the hypnotherapy group of the 74 randomized, 3 had withdrawn and 1 was lost. In the medication group, of 78 randomized: 4 had withdrawn and 2 were missing diaries.|||counts||95% Confidence Interval|Mean
2633084|NCT01829425|Secondary|Overactive Bladder Questionnaire Short Form Quality of Life|Overactive Bladder questionnaire-Short Form Quality of Life. Higher scores are better (higher quality of life) and lower scores are worse (poorer quality of life). score range 0-100.|12 months|At 12 months in the hypnotherapy group: 4 had withdrawn, 1 missing diary. In the medication group, 7 had withdrawn.|||sub-scale scores||95% Confidence Interval|Least Squares Mean
2633085|NCT01829425|Secondary|Overactive Bladder Questionnaire Short Form Quality of Life|Overactive Bladder questionnaire Short Form Quality of Life. Higher scores are better (better quality of life) and lower scores are worse (poorer quality of life). sub-scale score range 0-100.|6 months|At 6 months, in the hypnotherapy group: 4 had withdrawn and 2 were lost and 1 missing diary. In the medication group: 6 had withdrawn and 1 was lost.|||sub-scale scores||95% Confidence Interval|Least Squares Mean
2633086|NCT01829425|Secondary|Overactive Bladder Questionnaire Short Form Quality of Life|Overactive Bladder questionnaire-Short Form Quality of Life. Higher scores are better (better quality of life) and lower scores are worse (poorer quality of life). sub-score range 0-100.|2 months|Randomized patients with primary outcome (diary information) 2 months. Hypnotherapy: 74 randomized; 3 withdrawn, 1 lost=70 with primary outcome information used for analysis for secondary outcomes. Medications: 78 randomized-- 4 withdrawn, 2 were missing diary information=72 for analysis of secondary outcome.|||sub-scale scores||95% Confidence Interval|Least Squares Mean
2633087|NCT01829425|Secondary|Overactive Bladder Questionnaire Short Form Symptom Bother|Overactive Bladder Questionnaire Short Form symptom bother. Sub-scale range 0-100. Higher numbers are worse (more bother) and lower numbers are better (less bother)|12 months|12 months. Hypnotherapy: 74 randomized, 4 withdrawn & 1 was missing diary=69 analyzed with diary data. Medication: 78 randomized, 7 had withdrawn=71 analyzed with diary data.|||sub-scale scores||95% Confidence Interval|Least Squares Mean
2633393|NCT01825876|Primary|PK: Maximum Observed Concentration (Cmax) of S-Warfarin||Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose|All participants who received a dose of study drug and had evaluable data for Cmax.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2633088|NCT01829425|Secondary|Overactive Bladder Questionnaire Short Form Symptom Bother|Overactive Bladder Questionnaire Short Form symptom bother. Sub-scale range 0-100. Higher numbers are worse (more bother) and lower numbers are better (less bother)|6 months|At 6 months in the hypnotherapy group, 4 had withdrawn and 2 were lost and 1 missing diary. In the medication group, 6 had withdrawn and 1 was missing.|||sub-scale scores||95% Confidence Interval|Least Squares Mean
2633089|NCT01829425|Secondary|Overactive Bladder Questionnaire Short Form Symptom Bother|Overactive Bladder Questionnaire Short Form symptom bother Scale. Sub-Scale range 0-100. Higher numbers are worse (more bother) and lower numbers are better (less bother)|2 months|Randomized patients with primary outcome (diary information) 2 months. Hypnotherapy: 70 had diary information; of those randomized 3 had withdrawn, 1 was lost=70 with primary outcome information for analysis. Medications: 78 randomized-- 4 withdrawn. 2 were missing diary information=72 with primary outcome information for analysis|||scores on a sub-scale||95% Confidence Interval|Least Squares Mean
2633090|NCT01829425|Secondary|Percent Change in Urgency Urinary Incontinence Episodes|Percent change in median UUI episodes from baseline to 12 months with comparison made between hypnotherapy & pharmacotherapy|12 months|Pts with diary data at 12 months. For the Hypnotherapy group, of the 74 women randomized, 4 had withdrawn and 1 was missing diary data. For the medication group, of the 78 women randomized, 7 had withdrawn.|||percentage change in median UUI episodes||95% Confidence Interval|Median
2633091|NCT01829425|Secondary|Percent Change in Urgency Urinary Incontinence Episodes|Differences comparing hypnotherapy to pharmacotherapy percent change in median UUI episodes|6 months|At 6 months. Hypnotherapy: 74 women randomized-- 4 withdrawn, 2 lost and 1 missing diary information=67 analyzed with diary data. Medication: 78 randomized, 6 had withdrawn and 1 lost=71 analyzed with diary data|||percentage change in median UUI episodes||95% Confidence Interval|Median
2633092|NCT01829425|Primary|Percent Change in Urgency Urinary Incontinence Episodes|Percent change in UUI episodes from baseline to 2 months with comparison made between hypnotherapy & pharmacotherapy|Baseline and 2 month follow-up|Randomized patients with primary outcome (diary information) 2 months. Hypnotherapy: 74 randomized; of those randomized 3 had withdrawn, 1 was lost=70 with primary outcome information for analysis. Medications: 78 randomized-- 4 withdrawn. 2 were missing diary information=72 with primary outcome information for analysis|||percentage change in median UUI episodes||95% Confidence Interval|Median
2633093|NCT01829399|Secondary|Pain Score at Time of Tq Deflation|A visual analog pain score (VAS) from 0 to 10 was assessed at the time of Tq deflation. 0 indicating no pain, and 10 indicating the worst possible pain. All participants requested deflation prior to the maximum allowable 60 minutes, Subjects were instructed to request deflation at the same degree of discomfort for each visit. Due to a strong crossover effect, only the data assessed from the first intervention was analyzed.|Tq will be deflated upon subject's request. VAS is assessed at time of deflation for degree of discomfort prompting deflation request, up to 60 minutes post intervention.||||scores on a scale||95% Confidence Interval|Mean
2633094|NCT01829399|Primary|Time in Minutes That Tq Remained Inflated|15 minutes after either Bupivacaine or placebo injection, Tq was inflated to 100 mm Hg over subjects systolic blood pressure. When the subject found the Tq too uncomfortable, the Tq was deflated and the time documented. Approximately one month later, each subject had the opposite injection of either placebo or Bupivacaine on the same arm, and the duration of Tq inflation was again measured. Due to a strong crossover effect, only the data assessed from the first intervention was analyzed.|Tq was inflated 15 minutes after injection of Bupivacaine or placebo and remained inflated until subject could no longer tolerate it. Maximum allowable inflation time per session was 60 minutes.||||Minutes||95% Confidence Interval|Mean
2633095|NCT01829360|Secondary|Interim Naming|"Learning also was tracked during treatment. The research assistant who provided the treatment prompted children to name the target words at four points during each treatment. Depending on the arm, the four test points corresponded to 6-9 exposures, 18-20 exposures, 27-30 exposures, and 36 exposures. The research assistant showed the child the post-book reading picture without the orthographic label and asked a question meant to elicit the phonological form of the target word (e.g., What is the lightning doing? to elicit flashing). Specific feedback was not provided but the correct orthographic label and context sentence always were provided after the child's response regardless of the accuracy of the response. Responses were scored as correct (i.e., matched the target word) or incorrect (i.e., did not match the target word). Total score could range from 0 to 30 words correctly named in each treatment."|Administered during treatment, which lasted 5-12 weeks||||Number of words correct||Standard Error|Mean
2633096|NCT01829360|Secondary|Interim Definition|"Learning also was tracked during treatment. The research assistant who provided the treatment prompted children to provide definitions at four points during each treatment. Depending on the arm, the four test points corresponded to 6-9 exposures, 18-20 exposures, 27-30 exposures, and 36 exposures.The words were assessed in a fixed order while the child viewed the pre-reading pictures for each word. The research assistant asked, What does [word] mean?. Specific feedback was not provided but the correct definition always was provided after the child's response regardless of the accuracy of the response. Scoring was the same as that described for definitions administered pre/post. Scores could range from 0-30 words correctly defined."|Treatment lasted 5-12 weeks. Data was taken during this time.||||Number of words correct||Standard Error|Mean
2633097|NCT01829360|Primary|Change in Words Known From Pre- to Post-treatment|In each of the two treatments, children are taught 30 new words and tested on their ability to provide a definition of each word. Definitions are scored as 0 points for an incorrect or absent definition, 1 point for an appropriate use of the word in a sentence or for a vague definition, 2 points for a conventional definition containing at least one critical element but lacking other critical elements, and 3 points for a complete and accurate definition including all critical elements. For the analyses, children's definitions scored as 2 or 3 (i.e., a partially or completely accurate definition) were counted as correct (i.e., the child knows the word) and definitions scored as 0 or 1 (i.e., incorrect definition, absent definition, correct use of a word in a sentence, or vague definition) were counted as incorrect (i.e., the child does not know the word). Thus, children's scores could range from 0 to 30 words known, with higher scores indicating better outcomes.|Pre- and Post-treatment with treatment lasting 10 to 23 sessions (approximately 5 to 12 weeks)||||Number of words learned||Standard Error|Mean
2633098|NCT01829347|Secondary|Proportion of Survivors at Study Day 91.|Assess the proportion of survivors at Study Day 91.|Up to Study Day 91.||||Participants|||Count of Participants
2633099|NCT01829347|Primary|Overall Survival|The primary endpoint of the study was a comparison of overall survival (OS) between ELAD-treated and Control groups, with protocol VTI-210E providing additional survival data up to a maximum of 5 years, that was included as available at the time of database lock (11 July 2016).|Up to at least Study Day 91, with protocol VTI-208E providing additional survival data at the time of database lock (11 July 2016), approximately 27 months||||Participants|||Count of Participants
2633100|NCT01829295|Secondary|Number of Participants Achieving Treatment Success After Switching to Other Medication (Phase II, 0-6 Months)|Controlled ocular inflammation (≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and ≤ 2 drops/day of topical 1% prednisolone acetate for patients who crossed over to other medication following treatment failure at 6 months (or earlier).|6 Months|Patients who switched to the other medication following treatment failure at 6 months (or earlier). Patients were analyzed by the medication that they received in this second phase (Phase II, 0-6 Months).|||Participants|||Count of Participants
2633101|NCT01829295|Secondary|Number of Participants Achieving Treatment Success at 12 Months on Same Medication (Phase I, 6-12 Months)|Controlled ocular inflammation (≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and ≤ 2 drops/day of topical 1% prednisolone acetate in patients who were a treatment success at the primary outcome of 6 months.|12 Months|Patients who were a treatment success at 6 months and continued in follow-up.|||Participants|||Count of Participants
2633102|NCT01829295|Primary|Number of Participants Achieving Treatment Success at 6 Months (Phase I, 0-6 Months)|Controlled ocular inflammation (≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and ≤ 2 drops/day of topical 1% prednisolone acetate.|6 Months|All randomized patient with a 6-month visit, or who were declared early treatment failures, are included.|||Participants|||Count of Participants
2633103|NCT01829243|Secondary|MATRICS Consensus Cognitive Battery Composite Score|"(MATRICS) Consensus Cognitive Battery measures cognitive functioning within 7 domains: speed of processing, attention/vigilance, working memory (non verbal and verbal), verbal learning, visual learning, reasoning and problem solving and social cognition.~The composite score is calculated by the MATRICS computer program, which equally weights each of the 7 domain scores. The range of composite scores is 20-80. Higher scores indicate higher levels or cognitive functioning, while lower scores indicate lower levels of cognitive functioning."|Baseline, Week 6||||units on a scale||Standard Deviation|Mean
2633104|NCT01829243|Primary|Composite Brief Assessment of Cognition (BAC) Score|The composite BAC score is calculated by scoring each of the 6 individual tests (Verbal Memory Recall, Digit Sequencing, Token Motor Task, Verbal Fluency, Symbol Coding, and Tower of London), comparing each score to a healthy control sample to create z-scores, summing the z-scores, and rescaling the sum. The composite score range is -2127.8 to 1878.8, with higher scores indicating better cognition.|Baseline, Week 6||||units on a scale||Standard Deviation|Mean
2633105|NCT01829243|Primary|Changes in The Fatigue Severity Scale (FSS)|"The Fatigue Severity Scale (FSS) is composed of nine items with a seven-point response format. The minimum score = 9 and maximum score possible = 63. Higher scores = greater fatigue severity.~Sample questions include I am easily fatigued and Exercise brings on my fatigue. In the initial validation study, internal consistency for the Fatigue Severity Scale was high for specific illness groups (MS and lupus) and healthy controls. The scale clearly distinguished patients from controls and it was moderately correlated with a single-item visual analogue scale of fatigue intensity. In all patients, clinical improvement in fatigue was associated with reductions in scores on the Fatigue Severity Scale. The Fatigue Severity Scale is also a practical measure due to its brevity and ease of administration and scoring."|Baseline, Week 1, 2,4, and 6 weeks|Analysis employed Intent-to-Treat with Last Observation Carried Forward (LOCF) analysis. The Intent-to-Treat group (ITT) was comprised of all subjects who received at least one dose of the medication.|||units on a scale||Full Range|Mean
2633106|NCT01829243|Primary|Visual Analogue Scale for Pain|Visual Analogue Scale for Pain operationally is a 100 mm line anchored by word descriptors at each end. The patient marks a point on the line that reflects their current pain state. The distance in mm from the left anchor point is the score. Higher scores indicate more pain.|Baseline, Week 1, 2,4, and 6 weeks|Analysis employed Intent-to-Treat with Last Observation Carried Forward (LOCF) analysis. The Intent-to-Treat group (ITT) was comprised of all subjects who received at least one dose of the medication.|||mm||Full Range|Mean
2633107|NCT01829230|Primary|Spherical Equivalent Refractive Error|Cycloplegic spherical equivalent refraction of the subjects's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 5 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis.|Baseline and every 6 months up to 18 months|All subjects who have at least one data point.|||diopter (D)||Standard Deviation|Mean
2633108|NCT01829230|Primary|Axial Length of the Eye|Axial length was measured with the IOLMaster at baseline and then every 6 months throughout the course of the study. Five measurements were collected at each visit from the subject's right eye and the average of the 5 measurements was used for the analysis.|Baseline and every 6 months post-baseline up to 18 months|All subjects who have at least one data point.|||millimeter (mm)||Standard Deviation|Mean
2633109|NCT01829217|Primary|Objective Response Rate (ORR)|Percentage of patients with evidence of complete or partial response per RECIST1.1 criteria.|ORR was assessed at 6 weeks post-registration and every 6 weeks until date of documented disease progression or death, up to January 23, 2017 (approximately 44 months).||||percentage of participants||95% Confidence Interval|Number
2633110|NCT01829191|Secondary|Axial Length|Axial length was measured with the IOLMaster at baseline and every 6 months for 2 years. Five measurements were collected for each visit from the subject's right eye and the average of the five measurements was used for the analysis.|Baseline and every 6 months for 2 years|Analysis was conducted on all randomized subjects who have at least one data point.|||millimeter (mm)||Standard Deviation|Mean
2633188|NCT01828112|Secondary|Overall Intracranial Response Rate (OIRR)|OIRR is defined as the ORR based on lesions in brain (target, nontarget lesions (and new lesions, if applicable) and calculated as the proportion of patients with a best overall confirmed response of CR or PR in the brain per modified RECIST 1.1* as assessed by BIRC neuroradiologist.|Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks||2023-07-31|07/2023||||
2633111|NCT01829191|Primary|Spherical Equivalent Refractive Error|Cycloplegic spherical equivalent auto refraction of the subject's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measures, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values in spherical refraction indicate progression in Myopia.|Baseline and every 6 months post-baseline for 2 years|Analysis was conducted on all randomized subjects who have at least one data point.|||diopter (D)||Standard Error|Mean
2633112|NCT01829165|Other Pre-specified|fMRI-assessed Resting Connectivity|From pre- to post-treatment of patients with high-frequency repetitive TMS (rTMS) improvement shall be measured by normalization of baseline network-level deficits.|Up to 3 months.|||||||
2633113|NCT01829165|Other Pre-specified|Implicit Emotion Regulation|Implicit emotion regulation assessed through emotion conflict task performed during functional imaging. Performance based on reaction time and recruitment of emotion regulation regions during the task.|Up to 3 months|||||||
2633114|NCT01829165|Other Pre-specified|fMRI/TMS Assessed Neural Network Connectivity|From pre- to post-treatment, improvement will be based on enhanced functional connectivity.|Up to 3 months.|||||||
2633115|NCT01829165|Primary|Clinician Administered HAM-D|The Hamilton Depression Rating Scale (HAM-D) is a 24-item clinician-administered assessment utilized as a way of determining a patient's level of depression before, during, and after treatment. It takes approximately 15-20 minutes to complete the interview and score the results. Subscale scores are 0-2 (10 questions), 0-3 (2 questions), and 0-4 (12 questions). Subscales are totaled for an overall score (range 0 -76). For the overall score and all subscales, lower scores correspond to fewer symptoms, and higher scores correspond more symptoms.|Baseline; Day 10; Day 20|Randomized and treated|||units on a scale||Standard Deviation|Mean
2633116|NCT01829113|Secondary|Number of Patients With a Treatment-Related Adverse Event as a Measure of Safety.|A treatment-related adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator's assessment). Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03.|Weekly during each 21 days cycle and for 30 days after last dose for up to 29 Months|Randomized patients who received at least one dose of study treatment.|||Participants|||Count of Participants
2633117|NCT01829113|Secondary|Median Overall Survival|Defined as the time (in months) from date of randomization to date of death from any cause, or censored at the date last known alive.|Every 6 weeks for up to 41 months|All patients who were randomized.|||Months||95% Confidence Interval|Median
2633118|NCT01829113|Secondary|Number of OGX-427 Versus Placebo Participants With an Objective Response|Defined as the number of patients with objective evidence of complete or partial response (CR or PR) using RECIST v 1.1. A CR is the complete disappearance of all target lesions. A PR is a decrease in baseline of 30% or more of the diameter(s) of all target lesions.|Every 6 weeks for up to 24 months|All patients who were randomized.|||Participants|||Count of Participants
2633119|NCT01829113|Primary|Median Progression-Free Survival|Defined as the time (in months) from date of randomization to the date of first observation of progression based on radiological assessment by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, or date of death from any cause, in the absence of progressive disease (PD) or censored at the date of last adequate tumor assessment. Progressive Disease is defined by RECIST v1.1 as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum while on study (this includes the baseline sum if that is the smallest on study), or the appearance of one or more new lesions.|Every 6 weeks for up to 24 months|All patients who were randomized|||months||95% Confidence Interval|Median
2633120|NCT01829048|Primary|Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 24 Hours (Post Dose) on Day 18 (Cohort 3)||24 hours (post dose) on Day 18|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||ng/mL||Standard Deviation|Mean
2633121|NCT01829048|Primary|Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 5 Hours (Post Dose) on Day 18 (Cohort 3)||5 hours (post dose) on Day 18|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||ng/mL||Standard Deviation|Mean
2633122|NCT01829048|Primary|Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 1 Hour 30 Minutes (Post Dose) on Day 18 (Cohort 3)||1 hour 30 minutes (post dose) on Day 18|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||ng/mL||Standard Deviation|Mean
2633123|NCT01829048|Primary|Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 25 Minutes (Post Dose) on Day 18 (Cohort 3)||25 minutes (post dose) Day 18|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||ng/mL||Standard Deviation|Mean
2633124|NCT01829048|Primary|Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 0 Hour (Predose) on Day 18 (Cohort 3)||0 hour (predose) on Day 18|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||ng/mL||Standard Deviation|Mean
2633125|NCT01829048|Primary|Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 24 Hours (Post Dose) on Day 10 (Cohorts 1 and 2)||24 hours (post dose) on Day 10|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||ng/mL||Standard Deviation|Mean
2633126|NCT01829048|Primary|Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 5 Hours (Post Dose) on Day 10 (Cohorts 1 and 2)||5 hours (post dose) on Day 10|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||ng/mL||Standard Deviation|Mean
2633127|NCT01829048|Primary|Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 1 Hour 30 Minutes (Post Dose) on Day 10 (Cohorts 1 and 2)||1 hour 30 minutes (post dose) on Day 10|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||ng/mL||Standard Deviation|Mean
2633128|NCT01829048|Primary|Sparse PK Sampling for Population PK Analysis: PF-02545920 Concentration at 25 Minutes (Post Dose) on Day 10 (Cohorts 1 and 2)||25 minutes (post dose) on Day 10|PK concentration population included all enrolled participants treated who had at least 1 measurable concentration.|||ng/mL||Standard Deviation|Mean
2633130|NCT01829048|Primary|Number of Participants With ECG Data Meeting Criteria of Potential Clinical Concern (Cohort 3)|12-lead ECG (triplicate)was performed on Day 0 and 12-lead ECG (singlet) was performed at other time points as specified in timeframe. ECG criteria of potential clinical concern were 1), PR interval: >=300 msec; >=25% increase when baseline >200 msec; or increase >=50% when baseline <=200 msec; 2), QRS interval: >=140 msec; >=50% increase from baseline; 3), QTc interval: >=500 msec, QTcF interval: absolute value >=450 - <480 msec (borderline), >=480 msec (prolonged); absolute change 30 - <60 (borderline), >=60 msec (prolonged).|Screening up to Day 18|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2633131|NCT01829048|Primary|Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)|12-lead ECG (triplicate) was performed on Day 0 and 12-lead ECG (singlet) was performed at other time points as specified in timeframe. ECG criteria of potential clinical concern were 1), PR interval: >=300 milliseconds (msec); >=25% increase when baseline was greater than (>) 200 msec; or increase >=50% when baseline was less than or equal to (<=) 200 msec; 2), QRS interval: >=140 msec; >=50% increase from baseline; 3), corrected QT interval (QTc interval): >=500 msec, QTc interval using Fridericia's formula (QTcF interval): absolute value >=450 - <480 msec(borderline), >=480 msec (prolonged); absolute change 30 - <60 (borderline), >=60 msec (prolonged).|Day 0 (Baseline) up to Day 10|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
2633132|NCT01829048|Primary|Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohort 3)|Vital signs included BP (supine and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic >=30 mm Hg change from baseline in same posture, systolic <90 mm Hg; diastolic >=20 mm Hg change from baseline in same posture, diastolic <50 mm Hg; 2), pulse rate (supine/sitting): <40 or >120 bpm; Standing: <40 or >140 bpm.|Day 0 (Baseline) up to Follow-up (any day between Day 26 and 29)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
2633133|NCT01829048|Primary|Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern (Cohorts 1 and 2)|Vital signs included blood pressure (BP; supine and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic >=30 millimeters of mercury (mm Hg) change from baseline in same posture, systolic <90 mm Hg; diastolic >=20 mm Hg change from baseline in same posture, diastolic <50 mm Hg; 2), pulse rate (supine/sitting): <40 or greater than (>) 120 beats per minute (bpm); Standing: <40 or >140 bpm.|Day 0 (Baseline) up to Follow-up (any day between Day 17 and 20)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
2633134|NCT01829048|Primary|Number of Participants With Abnormal Clinical Laboratory Measurements (Cohort 3)|The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.|Day 0 (Baseline) up to Follow-up (any day between Day 26 and 29)|Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.|||Participants|||Number
2633135|NCT01829048|Primary|Number of Participants With Abnormal Clinical Laboratory Measurements (Cohorts 1 and 2)|The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.|Day 0 (Baseline) up to Follow-up (any day between Day 17 and 20)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
2633136|NCT01829048|Primary|Number of Participants With TEAEs (Cohort 3)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to last subject visit that were absent before treatment or that worsened relative to pretreatment state.|The time receiving the first dose of PF-02545920/placebo through the last Follow-up (any day between Day 26 and 29)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
2633137|NCT01829048|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) (Cohorts 1 and 2)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to last subject visit that were absent before treatment or that worsened relative to pretreatment state.|The time receiving the first dose of PF-02545920 or placebo through the last Follow-up (any day between Day 17 and 20)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
2633138|NCT01829048|Primary|Number of Participants With Abnormal Neurological Examination Findings (Cohort 3)|The neurological examination included observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger-nose, heel-shin, Romberg, tandem walking, positional and gaze-evoked nystagmus.|Day 0 up to Follow-up (any day between Day 26 and 29)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
2633139|NCT01829048|Primary|Number of Participants With Abnormal Neurological Examination Findings (Cohorts 1 and 2)|The neurological examination included observation for cerebellar (intention) tremor and for non-cerebellar tremors (eg, resting or positional), finger-nose, heel-shin, Romberg, tandem walking, positional and gaze-evoked nystagmus.|Day 0 up to Follow-up (any day between Day 17 and 20)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
2633140|NCT01829048|Primary|Number of Participants With Changes Since Screening in Physical Examination (Cohort 3)|A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems was performed at Screening. The limited or abbreviated physical examination was focused on general appearance, the respiratory and cardiovascular systems, as well as towards assessment of subject reported symptoms and performed at other time points than Screening.|Screening up to Follow-up (any day between Day 26 and 29)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
2633189|NCT01828112|Secondary|Time to Definitive Deterioration||from the date of randomization to the date of event for disease related symptoms||2023-07-31|07/2023||||
2633190|NCT01828112|Secondary|Patient Reported Outcomes (PRO)||Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks||2023-07-31|07/2023||||
2633141|NCT01829048|Primary|Number of Participants With Changes Since Screening in Physical Examination (Cohorts 1 and 2)|A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems was performed at Screening. The limited or abbreviated physical examination was focused on general appearance, the respiratory and cardiovascular systems, as well as towards assessment of subject reported symptoms and performed at other time points than Screening.|Screening up to Follow-up (any day between Day 17 and 20)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
2633142|NCT01829048|Primary|Number of Participants With Response to C-SSRS (Cohort 3) at Follow-up (Any Day Between Day 26 and 29)|"Data relevant to the assessment of suicidality was mapped to the C-CASA event codes. C-SSRS assessed whether participant experienced following: Completed suicide (Event code 1), Suicide attempt (Event code 2) (Response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (Event code 3) (Yes on aborted attempt, interrupted attempt, preparatory acts or behavior), suicidal ideation (Event code 4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) (Yes on Has participant engaged in non-suicidal self-injurious behavior). Number of participants with Yes response for above mentioned categories were assessed."|Follow-up (any day between Day 26 and 29)|Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.|||Participants|||Number
2633143|NCT01829048|Primary|Number of Participants With Response to C-SSRS (Cohort 3) at Day 19|"Data relevant to the assessment of suicidality was mapped to the C-CASA event codes. C-SSRS assessed whether participant experienced following: Completed suicide (Event code 1), Suicide attempt (Event code 2) (Response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (Event code 3) (Yes on aborted attempt, interrupted attempt, preparatory acts or behavior), suicidal ideation (Event code 4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) (Yes on Has participant engaged in non-suicidal self-injurious behavior). Number of participants with Yes response for above mentioned categories were assessed."|Day 19|Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.|||Participants|||Number
2633144|NCT01829048|Primary|Number of Participants With Response to C-SSRS (Cohort 3) at Baseline (Day 0)|"Data relevant to the assessment of suicidality was mapped to the C-CASA event codes. C-SSRS assessed whether participant experienced following: Completed suicide (Event code 1), Suicide attempt (Event code 2) (Response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (Event code 3) (Yes on aborted attempt, interrupted attempt, preparatory acts or behavior), suicidal ideation (Event code 4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) (Yes on Has participant engaged in non-suicidal self-injurious behavior). Number of participants with Yes response for above mentioned categories were assessed."|Day 0 (Baseline)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
2633145|NCT01829048|Primary|Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Follow-up (Any Day Between Day 17 and 20)|"Data relevant to the assessment of suicidality was mapped to the C-CASA event codes. C-SSRS assessed whether participant experienced following: completed suicide (Event code 1), Suicide attempt (Event code 2) (Response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (Event code 3) (Yes on aborted attempt, interrupted attempt, preparatory acts or behavior), suicidal ideation (Event code 4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) (Yes on Has participant engaged in non-suicidal self-injurious behavior). Number of participants with Yes response for above mentioned categories were assessed."|Follow-up (any day between Day 17 and 20)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
2633146|NCT01829048|Primary|Number of Participants With Response to C-SSRS (Cohorts 1 and 2) at Day 11|"Data relevant to the assessment of suicidality was mapped to the C-CASA event codes. C-SSRS assessed whether participant experienced following: completed suicide (Event code 1), Suicide attempt (Event code 2) (Response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (Event code 3) (Yes on aborted attempt, interrupted attempt, preparatory acts or behavior), suicidal ideation (Event code 4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) (Yes on Has participant engaged in non-suicidal self-injurious behavior). Number of participants with Yes response for above mentioned categories were assessed."|Day 11|Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.|||Participants|||Number
2633147|NCT01829048|Primary|Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) (Cohorts 1 and 2) at Baseline (Day 0)|"Data relevant to the assessment of suicidality was mapped to the Columbia-Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assessed whether participant experienced following: completed suicide (Event code 1), suicide attempt (Event code 2) (Response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (Event code 3) (Yes on aborted attempt, interrupted attempt, preparatory acts or behavior), suicidal ideation (Event code 4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) (Yes on Has participant engaged in non-suicidal self-injurious behavior). Number of participants with Yes response for above mentioned categories were assessed."|Day 0 (Baseline)|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Number
2633148|NCT01829048|Primary|Change From Baseline in ESRS-A Scores (Cohort 3) at Day 18|ESRS-A is a clinician rated scale consisting of 24 items to assess severity of extrapyramidal symptoms for following parameters: parkinsonism (10 items), dystonia (6 items), dyskinesia (6 items) and akathisia (2 items). Each item is scored on a 6-point Likert scale (0=absent, 1=minimal, 2=mild, 3=moderate, 4=severe, 5=extreme). Additionally, 4 CGI-S items were assessed on a 7-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=extremely ill): CGI-S parkinsonism; CGI-S dystonia; CGI-S dyskinesia; CGI-S akathisia.|Day 0 (Baseline) up to Day 18|Safety analysis set included all participants who received at least 1 dose of study medication. Participants analyzed indicated number of evaluable participants.|||Units on a scale||Standard Deviation|Mean
2633149|NCT01829048|Primary|Change From Baseline in Abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A) Scores (Cohorts 1 and 2) at Day 10|ESRS-A is a clinician rated scale consisting of 24 items to assess severity of extrapyramidal symptoms for following parameters: parkinsonism (10 items), dystonia (6 items), dyskinesia (6 items) and akathisia (2 items). Each item was scored on a 6-point scale (0=absent, 1=minimal, 2=mild, 3=moderate, 4=severe, 5=extreme). Additionally, 4 Clinical Global Impression of Severity (CGI-S) items were assessed on a 7-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=extremely ill): CGI-S parkinsonism; CGI-S dystonia; CGI-S dyskinesia; CGI-S akathisia.|Day 0 (Baseline) up to Day 10|Safety analysis set included all participants who received at least 1 dose of study medication.|||Units on a scale||Standard Deviation|Mean
2633150|NCT01828983|Primary|Spouse Self Report of Depression|Patient Health Questionnaire - Depression (PHQ)-9 measured at baseline, 6 and 12 months. Scores range from 0-27 with higher scores indicating more depressive symptoms.|Baseline, 6 months|Participants with data at baseline and 6 months|||units on a scale||Standard Error|Mean
2633151|NCT01828983|Primary|Spouse Self Report of Anxiety|Generalized Anxiety Disorder (GAD-7) measured at baseline, 6 and 12 months. Scores range from 0 to 21; higher scores equal more anxiety.|baseline, and 6 months|Participants who had data at baseline and 6 months|||units on a scale||Standard Error|Mean
2633152|NCT01828983|Primary|Spouse Self-report of Resilience|Connor-Davidson Resilience Scale (CD-RISC) measured at baseline, 6 and 12 months. Scores range from 0-100. Higher scores equal greater resilience.|Baseline, 6 months|Participants who had data at baseline and 6 months|||units on a scale||Standard Error|Mean
2633153|NCT01828593|Other Pre-specified|Change From Baseline in Duodenal Gut-associated Lymphoid Tissue (GALT) CD4+ T Cell Densities||Baseline and Week 24|Sub-study|||cells/mm3||Full Range|Mean
2633154|NCT01828593|Other Pre-specified|Change From Baseline in Peripheral CD4+ T Cell Counts in 4th Baseline CD4+ Quartile (Greater Than 893)|4th Baseline CD4+ Quartile (greater than 893)|Baseline and 4 weeks||||cells/microliter||Standard Deviation|Mean
2633155|NCT01828593|Other Pre-specified|Change From Baseline in Peripheral CD4+ T Cell Counts in 3rd Baseline CD4+ Quartile (Greater Than 630 and Less Than or Equal to 890)|3rd Baseline CD4+ Quartile (Greater than 630 and Less than or Equal to 893)|Baseline and 4 weeks||||cells/microliter||Standard Deviation|Mean
2633156|NCT01828593|Other Pre-specified|Change From Baseline in Peripheral CD4+ T Cell Counts in 2nd Baseline CD4+ Quartile (Greater Than 418 and Less Than or Equal to 630|2nd Baseline CD4+ Quartile (greater than 418 and less than or equal to 630)|Baseline and 4 weeks||||cells/microliter||Standard Deviation|Mean
2633157|NCT01828593|Other Pre-specified|Change From Baseline in Peripheral CD4+ T Cell Counts in Lowest Baseline CD4+ Quartile (Less Than or Equal to 418)|Lowest baseline CD4+ quartile (less than or equal to 418)|Baseline and 4 weeks||||cells/microliter||Standard Deviation|Mean
2633158|NCT01828593|Primary|Frequency of Daily Unformed Bowel Movements|Change in number of abnormal or unformed stools by week 4|Baseline and 4 weeks||||abnormal or unformed stools||Standard Deviation|Mean
2633159|NCT01828567|Secondary|Framingham Risk Score|The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. This is not a scale however, lower score indicates less risk.|6 months|Unknowns were removed from the denominator: Intervention n=22; control n=18.|||average score||Standard Deviation|Mean
2633160|NCT01828567|Secondary|Framingham Risk Score|The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. This is not a scale however, lower score indicates less risk.|Baseline|Unknowns were removed from the denominator: Intervention n=7; control n=2.|||average score||Standard Deviation|Mean
2633161|NCT01828567|Secondary|Patient Activation Measures|Patient Activation Measures (PAM) assesses patients capacity to manage their health. Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors. Minimum score is a zero and maximum is one hundred. Higher score is better. The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant|6 months assessments||||average score||Standard Deviation|Mean
2633162|NCT01828567|Secondary|Patient Activation Measures|Patient Activation Measures (PAM) assesses patients capacity to manage their health. Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors. Minimum score is a zero and maximum is one hundred. Higher score is better. The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant|1 month assessment||||average score||Standard Deviation|Mean
2633163|NCT01828567|Secondary|Patient Activation Measures (PAM)|Patient Activation Measures (PAM) assesses patients capacity to manage their health. Improvement in PAM scores indicate responsiveness to interventions and improvements in self-management behaviors. Minimum score is a zero and maximum is one hundred. Higher score is better. The protocol specifies co-primary outcomes with enrollment in prevention services specified as the most clinically relevant|Baseline assessment||||average score||Standard Deviation|Mean
2633164|NCT01828567|Primary|Enrollment in Prevention Services|Proportion of veterans enrolled in effective prevention services including weight loss, healthy eating, physical activity, and smoking cessation programs.|1 and 6 months (cumulative)|Unknowns were removed from the denominator: Intervention n=29; control n=15.|||participants|||Number
2633165|NCT01828554|Secondary|Progression Free Survival|Progression-free survival will be analyzed using the Kaplan-Meier method.|Up to 6 months|The median PFS has not been reached (NBR) within the follow-up period of this trial|||months||95% Confidence Interval|Median
2633169|NCT01828515|Primary|Change From Baseline RAVLT (Rey Auditory Verbal Learning Test) Total T-Score at Day 19|The Rey Auditory Verbal Learning Test (RAVLT) measures verbal or declarative learning and memory. The test consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. Following the fifth trial, an interference list of 15 different words is presented followed by a free-recall trial of that list. Delayed recall of the first list is tested immediately following the interference list and after a 20-minute delay. Equivalent, alternative versions (different words) were used to minimize practice or learning effects from repeated administration. The raw scores (number of words correct across trials 1-5) are converted to standardized T-scores (M=50; SD=10). This score is used to determine the participant's performance in relation to norm-referenced expectations based on age and sex. Higher score reflects better performance, and the values reflect scores at baseline minus the scores at Day 19.|Baseline and Day 19|All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.|||T-score||Standard Deviation|Mean
2633170|NCT01828476|Secondary|Overall Survival||5 years|Study was terminated early and insufficient data was collected to assess this outcome measure.||||||
2633171|NCT01828476|Secondary|Biomarkers of Autophagy Modulation by EM; and LC3, and/or p62 by Immunoblotting in PBMC and Tumor Tissue When Available||5 years|Study was terminated early and insufficient data was collected to assess this outcome measure.||||||
2633172|NCT01828476|Secondary|Bcl-2 Family Protein Expression (Bcl-2, Bcl-XL, MCL-1) in Paraffin Blocks When Available by Immunohistochemistry||5 years|Study was terminated warly and insufficient data was collected to assess this outcome measure.||||||
2633173|NCT01828476|Secondary|Circulating Tumor Cells Pre-enrollment and During Therapy||5 years|Study was terminated early and insufficient data was collected to assess this outcome measure.||||||
2633174|NCT01828476|Secondary|Measurable Tumor Response in Patients With Measurable Disease||5 years|Study was terminated early and insufficent data was collected to assess this outcome measure.||||||
2633175|NCT01828476|Secondary|Progression Free Survival||5 years|Study was terminated early and insufficient data were collected to assess this outcome measure.||||||
2633176|NCT01828476|Secondary|Time to PSA Progression||5 years|Study was terminated early and insufficient data were collected to assess this outcome measure.||||||
2633177|NCT01828476|Primary|Biochemical Response to ABT-263 and Abiraterone and to ABT-263 in Combination With Hydroxychloroquine and Abiraterone in Patients That Are Progressing on Abiraterone|"Characterize biochemical response to ABT-263 and Abiraterone and to ABT-263 in combination with hydroxychloroquine and Abiraterone by looking at PSA levels."|5 years|Study was terminated early and insufficient data was collected to assess this outcome measure.|||Participants|||Count of Participants
2633178|NCT01828281|Other Pre-specified|Mean Hours of CPAP Usage Per Day|Mean Hours of CPAP usage per day in those who continue to use CPAP during the three month period.|3 months||||hours||Standard Deviation|Mean
2633179|NCT01828281|Secondary|Mean Changes in Adiponectin Over 3 Months|Mean changes in Adiponectin from baseline to 3 months.|Baseline, 3 months||||ug/ml||Standard Deviation|Mean
2633180|NCT01828281|Primary|Mesenteric Fat Thickness||3 months||||cm||Standard Deviation|Mean
2633181|NCT01828216|Secondary|Difference in Healthcare Costs Between Ambulatory and Hospital Approach||within 24 months||||Hong Kong Dollars||Standard Deviation|Mean
2633182|NCT01828216|Primary|Change in Epworth Sleepiness Score (ESS) Before and After 3 Months of Continuous Positive Airway Pressure (CPAP) Treatment|The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire. The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives, though not necessarily every day. The scores for the eight questions are added together to obtain a single number. A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates that expert medical advice should be sought.|Baseline and 3 months|Following detection of apnea-hypopnea index (AHI) of 15 events per hour or more by home sleep study or polysomnography, patients received CPAP therapy for 3 months after an overnight autoCPAP titration at in-hospital or ambulatory home setting.|||units on a scale||Standard Deviation|Mean
2633183|NCT01828164|Secondary|Discomfort|Average measured level of subject discomfort or pain. The Participant Pain Reporting Scale is used to assess the amount of pain on a 10 point scale. On the 10 point scale, 1 represents the least amount of pain and 10 represents the most amount of pain.|24 weeks or until the extraction space was closed (whichever came first)|Subjects who completed the study with device usage compliance of 67% or higher.|||units on a scale||Standard Deviation|Mean
2633184|NCT01828164|Secondary|Rate of Root Resorption|The weekly rate of tooth root resorption (mm/week) as compared between the treated side and the control side.|24 weeks or until the extraction space was closed (whichever came first)|Subjects who completed the study with device usage compliance of 67% or higher and with functional devices were evaluated. Only subjects with CBCT images were used.|||mm/week||Standard Deviation|Mean
2633185|NCT01828164|Primary|Rate of Tooth Movement|The weekly rate of tooth movement (mm/week) as compared between the treated side and the control side.|24 weeks or until the extraction space was closed (whichever came first)|As per approved protocol, only subjects who completed the study with device usage compliance of 67% or higher and with functional devices were evaluated.|||mm/week||Standard Deviation|Mean
2633186|NCT01828112|Secondary|Duration of Intracranial Response (DOIR)|DOIR is defined as the DOR based on lesions in brain (target, non-target lesions (and new lesions, if applicable) and calculated from the time of first documented response of CR or PR to the date of the first documented disease progression in the brain or death due to any cause per modified RECIST 1.1* as assessed by BIRC neuro-radiologist.|Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks||2023-07-31|07/2023||||
2633187|NCT01828112|Secondary|Intracranial Disease Control Rate (IDCR)|IDCR is defined as the DCR based on lesions in brain (target, non-target lesions (and new lesions, if applicable) and calculated as the proportion of patients with a best overall response of CR or PR or SD (or non-CR/nonPD) in the brain per modified RECIST 1.1* as assessed by BIRC neuro-radiologist.|Screening, followed by every 6 weeks until Month 18 after Month 18 every 9 weeks||2023-07-31|07/2023||||
2633191|NCT01828112|Secondary|Time to Response (TTR)|TTR is defined as the time from date of randomization to date of first documented response (CR or PR)|Month 18||2023-07-31|07/2023||||
2633196|NCT01828112|Primary|Progression Free Survival (PFS) Blinded Independent Review Committee Per Blinded Independent Review Committee (BIRC)|PFS is defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.|'from the date of randomization to the date of first radiologically documented disease progression or death due to any cause up to approximately 24 months|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.|||Percentage of participants||95% Confidence Interval|Median
2633197|NCT01828099|Secondary|Patient Reported Outcomes|The time to definitive deterioration from the date of randomization to the date of event for disease related symptoms.|Screening, followed by every 6 weeks until Month 33 after Month 33 every 9 weeks.||2022-04-30|04/2022||||
2633198|NCT01828099|Secondary|Time to Response (TTR)|TTR defined as the time from date of randomization to date of first documented response (CR or PR)|From randomization until death (up to approximately 34 months)||2022-04-30|04/2022||||
2633199|NCT01828099|Secondary|Disease Control Rate (DCR)|DCR defined as the proportion of patients with best overall response of CR, PR, or Stable Disease (SD)|From randomization until death (up to approximately 34 months)||2022-04-30|04/2022||||
2633200|NCT01828099|Secondary|Duration of Response (DOR)|DOR defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause|From randomization until death (up to approximately 34 months)||2022-04-30|04/2022||||
2633201|NCT01828099|Secondary|Overall Response Rate (ORR)|ORR defined as the proportion of patients with a best overall response defined as Complete Response (CR) or Partial Response (PR) as evaluated by Blinded Independent Review Committee (BIRC) and by investigator assessment per RECIST 1.1|From randomization until death (up to approximately 34 months)||2022-04-30|04/2022||||
2633202|NCT01828099|Secondary|Overall Survival (OS)|OS defined as time from date of randomization to date of death due to any cause|From randomization until death (up to approximately 34 months)||2022-04-30|04/2022||||
2633203|NCT01828099|Primary|Progression Free Survival (PFS) by Blinded Independent Review Committee (BIRC)|PFS defined as time from date of randomization to date of first documented disease (as assessed by Blinded Independent Review Committee (BIRC) per RECIST 1.1) or date of death due to any cause|from the date of randomization to the date of first radiologically documented disease progression or death due to any cause (assessed every 6 weeks up to approximately 34 months)|The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the treatment and strata to which they had been assigned during the randomization procedure.|||months||95% Confidence Interval|Median
2633204|NCT01828073|Secondary|Neonatal RAL Elimination (T1/2) by UGT1A1 Genotype Group (Normal VS Mutation)|Neonatal RAL elimination was the time required for neonatal plasma concentration to decrease by one-half. Genotyping for polymorphisms of UGT1A1 were performed on infants who were eligible for PK sampling and were consented by their mothers/guardians(i.e. genotyping was optional) . The goal of the genotypic analysis is to determine if certain polymorphisms, particularly those with the UGT1A1*28/*28 genotype have slower RAL elimination than those with the UGT1A1*1/*1 genotype.|Genotype was assessed close to birth and if this is not possible at 1-2 wks after birth. PK samples were collected at 1-5, 8-14, 18-24 and 30-36 hrs after birth for Cohort 1; 1-6, 12-24, 36-48, 72-84 and 108-132 hrs after birth, and day 7-14 for Cohort 2.|Infants with data on UGT1A1 genotype and RAL half-life (T1/2)|||Hours||Inter-Quartile Range|Median
2633205|NCT01828073|Primary|Number of Infants Who Received Treatment to Reduce Bilirubin or for Jaundice|Assessment if infant received exchange transfusion, Phototherapy, or other treatment to reduce bilirubin or for jaundice|Assessed from entry through around week 1 after birth|All infants.|||Participants|||Count of Participants
2633206|NCT01828073|Primary|Infant Direct Bilirubin|Direct bilirubin measured from infant blood specimens.|Measured at 8-14 hours (Visit 1), 30-36 hours (Visit 2) and 1-2 weeks (Visit 3) after birth for Cohort 1; and at 36-48 hours (Visit 1), 72-84 hours (Visit 2) and 1 week (Visit 3)after birth for Cohort 2.|Infants with Direct Bilirubin results|||mg/dL||Inter-Quartile Range|Median
2633207|NCT01828073|Primary|Infant Total Bilirubin|Total bilirubin measured from infant blood specimens.|Measured at 8-14 hours (Visit 1), 30-36 hours (Visit 2) and 1-2 weeks (Visit 3) after birth for Cohort 1; and at 36-48 hours (Visit 1), 72-84 hours (Visit 2) and 1 week (Visit 3)after birth for Cohort 2.|Infants with total bilirubin results|||mg/dL||Inter-Quartile Range|Median
2633208|NCT01828073|Primary|Number of Infants Who Met Composite Safety Endpoint (Grade 3/4 Adverse Event, Adverse Birth Outcome, Death)|"An infant was said to have met the composite safety endpoint if any of the following was observed:~adverse events (AEs) of Grade 3 or 4 as defined in DAIDS AE Grading Table~adverse birth outcomes including stillbirth and low birth weight (LBW), or~death.~Stillbirth could only be observed on infants enrolled prior to delivery. Cohort 2 enrolled LBW infants and prematurity and growth restriction which were highly linked to LBW were considered as baseline events and not AEs or adverse birth outcome for Cohort 2 infants."|Assessed at entry through Week 20 for Cohort 1 infants and through Week 6 for Cohort 2 infants.|All infants.|||Participants|||Count of Participants
2633209|NCT01828073|Primary|Ratio of Cord Blood to Maternal Blood RAL Concentrations|Ratio of the neonatal cord blood RAL concentration to the mother's plasma RAL concentration at birth|Maternal blood samples were scheduled to be collected within 1 hour after delivery and cord blood sample were collected immediately after cord was clamped|Mother-Infant (M-I) pairs with maternal blood and cord blood samples. Excluded were (i) 3 Cohort 1 M-I pairs with neither cord blood nor maternal blood samples; and (ii) 16 Cohort 2 M-I pairs: 5 had neither cord blood nor maternal blood specimens, 11 had no cord blood specimen.|||ratio||Full Range|Median
2633210|NCT01828073|Primary|PK Parameter: Neonatal RAL Elimination Half-life (T1/2)|Time required for neonatal plasma concentration to decrease by one-half. T1/2 was estimated using the terminal 3 concentration-time points for each infant when available.|Infant blood specimens were collected at 1-5, 8-14, 18-24, and 30-36 hours after birth for Cohort 1; and at 1-6, 12-24, 36-48, 72-84, and 108-132 hours after birth, and on day 7-14 for Cohort 2.|Infants with RAL concentration (conc) for whom T1/2 could be calculated. Excluded (i) 5 Cohort 1 infants: 2 had no data, 3 had data but could not calculate T1/2 (terminal RAL conc below level of quantification (BLQ), higher RAL conc at later collection time); and (ii) 1 Cohort 2 infants:1 had terminal RAL conc BLQ.|||Hours||Full Range|Median
2635253|NCT01806506|Secondary|Plasma Glucagon at 12 Months|Glucagon is synthesized and secreted from alpha cells of the pancreas. It leads to elevation of the plasma glucose.|12 months after surgery|||||||
2633211|NCT01827839|Secondary|Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Starting after 30 days post last vaccination until study end (i.e. Month 14)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Participants|||Count of Participants
2633212|NCT01827839|Secondary|Number of Subjects With SAEs|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Starting after 30 days post last vaccination until study end (i.e. Month 14)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Participants|||Count of Participants
2633213|NCT01827839|Secondary|Number of Subjects With Anti-gE Antibody Concentrations Equal to or Above the Cut-off Value|The cut-off value was 97 mIU/mL.|At Month 0 and at Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Participants|||Count of Participants
2633214|NCT01827839|Secondary|Anti-gE Antibody Concentrations|Anti-gE antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The outcome was assessed in each of the following age ranges: 50-59 YOA, 60-69 YOA and ≥ 70 YOA, in terms of antibody concentrations.|At Month 0 and at Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2633215|NCT01827839|Primary|Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From first vaccination up to 30 days post last vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Participants|||Count of Participants
2633216|NCT01827839|Primary|Number of Subjects With Any Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination up to 30 days post last vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.|||Participants|||Count of Participants
2633217|NCT01827839|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0-29) after each vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered.|||Participants|||Count of Participants
2633218|NCT01827839|Primary|Number of Days With Solicited General Symptoms|The number of days with general symptoms during the solicited post-vaccination period.|Within 7 days (Day 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with results available for this assessment.|||Days||Inter-Quartile Range|Median
2633219|NCT01827839|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and temperature [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 7 days (Day 0-6) after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the study vaccine administered and with the symptoms sheet filled in.|||Participants|||Count of Participants
2633220|NCT01827839|Primary|Number of Days With Solicited Local Symptoms|The number of days with any local symptoms during the solicited post-vaccination period.|Within 7 days (Day 0-6) after each vaccine dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and with results available for this assessment.|||Days||Inter-Quartile Range|Median
2633221|NCT01827839|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within 7 days (Day 0-6) after each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and with the symptoms sheet filled in.|||Participants|||Count of Participants
2633222|NCT01827839|Primary|Number of Vaccine Responders for Anti-gE Antibodies as Determined by ELISA|"Vaccine response was defined as:~For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for anti-gE [4x97 milli-international units per milliliter (mIU/mL)]; For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration."|At Month 3|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.|||Participants|||Count of Participants
2633223|NCT01827787|Post-Hoc|Overall Survival|OS based on Kaplan-Meier is defined as the time from study entry to death or censored at date last known alive.|Overall median survival follow-up was 5.9 months including a maximum of 27 months for Cohort 1 and 15 months for Cohort 2.||||months||90% Confidence Interval|Median
2633224|NCT01827787|Secondary|Functional Assessment of Cancer Therapy-Neurotoxicity Subscale (FACT-Ntx) Change Score From Baseline|The FACT-Ntx is a validated, self-administered questionnaire which captures quality of life (QOL) concerns specific to patients suffering from neurotoxicity. (Calhoun EA, et al. Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx) questionnaire for patients receiving systemic chemotherapy. Int J Gynecol Cancer 2003; 13:741-8). The FACT-Ntx has 11-items scored on a 5-point Likert scale (Not at all, A little bit, Somewhat, Quite a bit, Very much) with a maximum score of 44. A higher score indicates better QOL. A minimal clinically important difference is 3-5 points.|Assessed at baseline and on treatment day 1 of cycles 2, 3, 5, 7, 9 and 11|The analysis dataset is comprised of all participants who completed both QOL assessments required to calculate change from baseline. Per protocol, the cohorts were combined for this analysis.|||units on a scale||Standard Deviation|Mean
2633225|NCT01827787|Secondary|Functional Assessment of Cancer Therapy-Breast Cancer Subscale (FACT-BCS) Change Score From Baseline|The FACT-BCS is a validated, self-administered questionnaire which captures quality of life (QOL) concerns specific to breast cancer patients. (Brady MJ, et al. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. JCO 1997; 15:974-86). The FACT-BCS has 9-items scored on a 5-point Likert scale (Not at all, A little bit, Somewhat, Quite a bit, Very much) with a maximum score of 36. A higher score indicates better QOL. A minimal clinically important difference is 3-5 points.|Assessed at baseline and on treatment day 1 of cycles 2, 3, 5, 7, 9 and 11|The analysis dataset is comprised of all participants who completed both QOL assessments required to calculate change from baseline. Per protocol, the cohorts were combined for this analysis.|||units on a scale||Standard Deviation|Mean
2633226|NCT01827787|Secondary|Percentage of Participants With Grade 1-3 Treatment-Related Peripheral Motor Neuropathy|TThe percentage of treated participants experiencing grade 1-3 peripheral motor neuropathy with treatment attribution of possible, probable or definite based on Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) as reported on case report forms.|Adverse events were assessed every cycle throughout treatment. Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2)|The analysis dataset is comprised of all treated participants.Per protocol, the cohorts were combined for this analysis.|||percentage of participants||90% Confidence Interval|Number
2633227|NCT01827787|Secondary|Percentage of Participants With Grade 1-3 Treatment-Related Peripheral Sensory Neuropathy|The percentage of treated participants experiencing grade 1-3 peripheral sensory neuropathy with treatment attribution of possible, probable or definite based on Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) as reported on case report forms.|Adverse events were assessed every cycle throughout treatment. Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2)|The analysis dataset is comprised of all treated participants. Per protocol, the cohorts were combined for this analysis.|||percentage of participants||90% Confidence Interval|Number
2633228|NCT01827787|Secondary|Duration of Overall Response (DOR)|DOR is defined as the that response criteria for CR or PR (whichever is recorded first) are first met until the date that PD or death from any cause is first objectively documented. Participants who do not have PD will be censored on date of last disease assessment.|Disease was evaluated radiologically at baseline and every 9 weeks on and off treatment; Median (maximum) DOR follow-up was 12.6 (27.1) months in Cohort 1 and 12.4 (14.3) months in Cohort 2.|The analysis dataset is comprised of all enrolled participants.|||months||Full Range|Median
2633229|NCT01827787|Secondary|Time to First Response (TTR)|TTR is defined as the time from first dose of study treatment until the earliest date that complete response (CR) or partial response (PR) based on RECIST 1.1 criteria is objectively documented. Non-CR, non-PR participants are censored at date of last disease assessment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response requires 4 week or later confirmation and assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 9 weeks on treatment; Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2).|The analysis dataset is comprised of all enrolled participants.|||months||Full Range|Median
2633230|NCT01827787|Secondary|Progression-Free Survival (PFS)|PFS based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD are censored at date of last disease assessment. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum longest diameter (LD), taking as reference the smallest sum on study with at least 5 mm absolute increase or the appearance of one or more new lesions. For non-target lesions, PD is appearance of one or more new lesions or unequivocal progression of existing non-target lesions.|Disease was evaluated radiologically at baseline and every 9 weeks on and off treatment; Median (maximum) PFS follow-up was 12.6 (27.1) months in Cohort 1 and 12.4 (14.3) months in Cohort 2.|The analysis dataset is comprised of all enrolled participants.|||months||90% Confidence Interval|Mean
2633231|NCT01827787|Primary|Overall Response Rate (ORR)|ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 9 weeks on treatment; Maximum treatment duration was 38 cycles/26 months (Cohort 1) and 17 cycles/12 months (Cohort 2)||||percentage of participants||90% Confidence Interval|Number
2633240|NCT01827592|Secondary|Change From Baseline in Weekly Degree of Straining of SBMs|"The degree of straining was measured using the five-point ordinal scale (1=Not at all, 2=A little bit, 3=A moderate amount, 4=A great deal, and 5=An extreme amount).~For a given assessment week, the weekly degree of straining was defined as the sum of non-missing straining score for SBMs during that week divided by the number of non-missing straining score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2633232|NCT01827670|Secondary|Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS)|The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF|Baseline - Week 8|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2|||Score on a Scale||Standard Deviation|Mean
2633233|NCT01827670|Secondary|Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS)|The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF|Baseline-Week 4|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2|||Score on a Scale||Standard Deviation|Mean
2633234|NCT01827670|Secondary|Mean Change From Baseline in Tactile Sensitivity|"The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a yes response (pain was elicited) was recorded or the maximum force has been reached."|Baseline-Week 4|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2|||Grams||Standard Deviation|Mean
2633235|NCT01827670|Secondary|Mean Change From Baseline in Tactile Sensitivity|"The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a yes response (pain was elicited) was recorded or the maximum force has been reached."|Baseline-Week 8|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2|||Grams||Standard Deviation|Mean
2633236|NCT01827670|Secondary|Mean Change From Baseline in Schiff Sensitivity Score|"The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS).~Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation"|Baseline-Week 4|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2|||Score on a Scale||Standard Deviation|Mean
2633237|NCT01827670|Primary|Mean Change From Baseline in Schiff Sensitivity Score|"The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS).~Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation"|Baseline-Week 8|Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2|||Score on a scale||Standard Deviation|Mean
2633238|NCT01827592|Secondary|Change From Baseline in Weekly Abdominal Discomfort Score|"The abdominal discomfort score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).~For a given assessment week, the weekly abdominal discomfort score was defined as the sum of non-missing abdominal discomfort score for SBMs during that week divided by the number of non-missing abdominal discomfort score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2633239|NCT01827592|Secondary|Change From Baseline in Weekly Abdominal Bloating Score|"The abdominal bloating score was measured using the five-point ordinal scale (1=None, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe).~For a given assessment week, the weekly abdominal bloating score was defined as the sum of non-missing abdominal bloating score for SBMs during that week divided by the number of non-missing abdominal bloating score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2633279|NCT01827267|Secondary|Overall Survival (OS)|Defined as the time (month) from randomization to death due to any cause; censored at the date last known alive.|From randomization to death or end of long term follow-up, assessed up to 31.8 months.|All subjects who received at least 1 dose of drug|||months||95% Confidence Interval|Median
2633241|NCT01827592|Secondary|Total Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score Responder|"This outcome measured the percentage of patients who were PAC-QOL score responder at 12-week of Treatment Period. A PAC-QOL score responder was defined as a patient with ≥50% reduction in total PAC-QOL score from Baseline at Week 12.~PAC-QOL is a 28-item questionnaire for psychometric assessment of disease-specific quality of life. The questionnaire is based on 5-point Likert scale; ranging from 0 [none of the time or not at all] to 4 [all of the time or extremely]). A lower score indicates a better Quality of Life. The PAC-QOL questionnaire is developed specifically for patients with constipation.~Total PAC-QOL score was averaged from the individual item score."|At 12 weeks|The ITT analysis set consisted of all randomized (as planned) patients.|||Percentage of patients|||Number
2633242|NCT01827592|Secondary|Change From Baseline in Weekly Stool Consistency of SBMs|"The stool consistency is measured using the seven-point ordinal Bristol Stool Form Scale (BSFS) score. The BSFS classifies human stool into seven types and points them accordingly.~Type 1: Separate hard lumps, like nuts (hard to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid Types 1 and 2 indicate constipation, with 3 and 4 represents the ideal stool form (especially the latter), and 5, 6 and 7 tends towards diarrhoea .~For a given assessment week, the weekly stool consistency was defined as the sum of non-missing stool consistency score for SBMs during that week divided by the number of non-missing stool consistency score for SBMs during that week. The parameter was analysed using repeated measures ANCOVA model."|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.|||Units on BSFS||95% Confidence Interval|Least Squares Mean
2633243|NCT01827592|Secondary|Change From Baseline in Weekly Frequency of Spontaneous Bowel Movements (SBMs)|The change from Baseline for the continuous variable was estimated using a repeated measures analysis of covariance (ANCOVA) model.|From Baseline (2-week Pretreatment Period) to overall first 12-weeks of Treatment Period|The ITT analysis set consisted of all randomized (as planned) patients.|||SBM per week||95% Confidence Interval|Least Squares Mean
2633244|NCT01827592|Secondary|Occurrence of CSBM Response|This outcome measured the percentage of patients who had a CSBM within 24 hours after the first dose of treatment. A CSBM was defined as a spontaneous (occurring without laxative within the preceding 24 hours, including no rescue medication within the preceding 24 hours) bowel movement (as interpreted by the patient, with a beginning and an end, including single or multiple stools), accompanied by a patient reported sense of complete evacuation ('complete').|Within the first 24 hours of treatment initiation|The ITT analysis set consisted of all randomized (as planned) patients was used for assessment.|||Percentage of patients|||Number
2633245|NCT01827592|Primary|Overall Complete Spontaneous Bowel Movement (CSBM) Response|This outcome measured the percentage of patients who were CSBM responders. A CSBM responder was defined as a patient with ≥3 CSBMs per week and an increase of ≥1 CSBM per week from Baseline, for at least 9 of the 12 weeks in the 12-week Treatment Period, including at least 3 weeks during Weeks 9-12.|During the first 12 weeks|Intention-to-treat (ITT) analysis set consisted of all randomized (as planned) patients.|||Percentage of patients|||Number
2633246|NCT01827475|Secondary|Need for Rescue Pain Relief|The need for additional analgesics|1 hour||||participants|||Number
2633247|NCT01827475|Primary|Pain Severity|Pain score on 100 mm VAS from 0 (no pain) to 100 (worst pain)|1 hour||||mm||95% Confidence Interval|Mean
2633248|NCT01827462|Other Pre-specified|Evaluate Changes in Cytokine Profile in the Immune Response From Day 0 to Day 28-32 for Responses to the Vaccine Antigens||Day 0-Day28|||||||
2633249|NCT01827462|Other Pre-specified|Evaluate Changes in Cytokine Profile in the Immune Response From Day 0 to Day 5-7 for T Cells and Antibody-secreting Cells (ASCs)||Day 0 to 7|||||||
2633250|NCT01827462|Secondary|Number of Participants With Related Adverse Events|Related adverse events were recorded annually during this 10 year longitudinal study.|Day 0 to Day 28 following each annual vaccination while on study||||Participants|||Count of Participants
2633251|NCT01827462|Primary|Number of Participants Who Received the Influenza Vaccine||Day 0 annually while on study||||Participants|||Count of Participants
2633252|NCT01827371|Secondary|Number of Subjects Experiencing Serious Adverse Events (SAEs) Associated With IMVAMUNE|"Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes. Association with IMVAMUNE was determined by the investigator and defined as Related, meaning a reasonable possibility that the study product caused the adverse event. Reasonable possibility was defined as there being evidence to suggest a causal relationship between the study product and the adverse event."|Day 1 after the first vaccination through 180 days after the 2nd vaccination.|All subjects receiving at least one vaccination are included in the analysis population 'as treated', so one subject randomized to Arm C vaccinated out of window, equivalent to the schedule for Arm A, was analyzed for this outcome measure as Arm A.|||participants|||Number
2633253|NCT01827371|Secondary|Geometric Mean Peak ELISA Titer After Second Vaccination|Blood was collected from all participants at 8, 15, 22 and 29 days after receipt of the second vaccination for assessment of antibody titers by ELISA. The peak titer for each participant was defined as the highest titer among all available measurements post second vaccination. The geometric mean for each group was then assessed from individual participants' peak titers.|Day 7 through 31 after the 2nd vaccination|The modified ATP population was defined as all participants who received both vaccinations in window, excluding those who did not have a complete dose delivered or received non-study vaccinations. Only measurements (blood draws) between Days 7-31 were considered and subjects had to have at least two measurements in that range to be included.|||titers||95% Confidence Interval|Geometric Mean
2633307|NCT01827046|Secondary|Clot Removal (Amount of Residual Blood)|Relationship between clot removal as an Area Under the Curve (AUC) clot-assessment that estimates the time-averaged clot volume from ictus to end of treatment (EOT i.e. 24 hours after last dose) as AUC clot exposure and functional outcome (proportion 0-3 Modified Rankin Scale (mRS)).|24 hours after last dose|Includes patients who survived through the dosing period|||10mL x days||Standard Deviation|Mean
2633254|NCT01827371|Primary|Percentage of Participants Reporting Moderate or Severe Solicited Local Injection Site Reactions After Receiving Vaccine Via the Stratis™ Compared to Syringe and Needle Administration|Participants maintained a memory aid to record daily the occurrence of local injection site reactions for 15 days after vaccination based on their interference with daily activities (pain and itchiness at injection site, underarm pain and swelling) or based on a quantitative measurement of the reaction (redness, swelling). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions were present but did not interfere with daily activities. For the quantitative scale, severe reactions greater than 30 millimeters (mm), moderate reactions were 15-30mm, and mild reactions were 1-15mm. Participants are counted by the maximum severity on any of the 15 days, and for this outcome measure, only those reporting moderate or severe events are counted. Formal comparisons by Fisher's Exact test were conducted for Arm D (Stratis, Day 1,29) compared to A|15 days after each vaccination|All subjects receiving at least one vaccination are included in the analysis population 'as treated', so one subject randomized to Arm C vaccinated out of window, equivalent to the schedule for Arm A, was analyzed for this outcome measure as Arm A.|||percentage of participants|||Number
2633255|NCT01827371|Primary|Geometric Mean Peak Plaque Reduction Neutralization Titer (PRNT) After Second Vaccination|Blood was collected from all participants at 8, 15, 22 and 29 days after receipt of the second vaccination for assessment of plaque reduction neutralization titers. The peak titer for each participant was defined as the highest titer among all available measurements post second vaccination. The geometric mean for each group was then assessed from individual participants' peak titers.|Day 7 through Day 31 after 2nd vaccination|The modified ATP population was defined as all participants who received both vaccinations in window, excluding those who did not have a complete dose delivered or received non-study vaccinations. Only measurements (blood draws) between Days 7-31 were considered and subjects had to have at least two measurements in that range to be included.|||titers||95% Confidence Interval|Geometric Mean
2633256|NCT01827358|Secondary|Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no SA is Detected in the Nares, Umbilical, and Perianal Areas Using the According to Protocol Day 8 (ATP-8) Cohort.|Time until decolonization: Count of participants from Day 1 until the first NUP collection with no SA is detected in the nares, umbilical, and perianal areas using the according to protocol day 8 (ATP-8) cohort. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the SA decolonization to occur at the start of the interval, were still on study and had not yet had SA decolonization but were still being watched for the event. SA decolonization was the absence of SA detected from the NUP cultures through direct plating. Censored participants were at risk for some of the interval, did not have SA decolonization but were removed from eligibility for the event at some point after the interval started.|Day 1 through 85|The ATP-8 cohort includes all ATP infants who had a set of NUP cultures collected on Day 8 (± 2).|||Participants|||Count of Participants
2633257|NCT01827358|Secondary|Time Until Decolonization: Count of Participants From Day 1 Until the First NUP Collection With no S. Aureus (SA) Detected in the Nares, Umbilical, and Perianal Areas Using the Modified Intent to Treat Day 8 Cohort (mITT-8).|Time until decolonization: Count of participants from Day 1 until the first NUP collection with no SA is detected in the nares, umbilical, and perianal areas using the modified intent to treat (mITT-8) cohort. The time periods in the table correspond to the study days having collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the SA decolonization to occur at the start of the interval, were still on study and had not yet had SA decolonization but were still being watched for the event. SA decolonization was the absence of SA detected from the NUP cultures through direct plating. Censored participants were at risk for some of the interval, did not have SA decolonization but were removed from eligibility for the event at some point after the interval started.|Day 1 through 85|The mITT cohort includes all infants with a site-specific pre-randomization NUP culture that was positive for SA by direct culture. The mITT-8 cohort includes all mITT infants who either had a complete set of NUP cultures collected on day 8 or else had discontinuation of NUP cultures prior to Day 8 due to a clinical SA infection.|||Participants|||Count of Participants
2633258|NCT01827358|Secondary|Relative Risk of Severe (Stage II-III) Necrotizing Enterocolitis (NEC) in the Treatment Compared to Control Group|The association between mupirocin treatment and severe (stage II-III) NEC on or before Day 85 was to be assessed via Cox Proportional Hazards Model.|Day 1 through 85|There were no events of necrotizing enterocolitis during the study, analysis could not be performed.||||||
2633259|NCT01827358|Secondary|Median Time to Occurrence of Non-S. Aureus (SA) Clinical Infection in the Treatment Compared to Control Group|Median time to occurrence of non-SA clinical infection in the treatment compared to control group as estimated using Kaplan-Meier estimates of the survival curves.|Day 1 through 85|Clinical infection besides SA infection on or prior to Day 85 was not observed frequently enough to allow estimation of the median time to infection using non-parametric methods.||||||
2633260|NCT01827358|Secondary|Protective Efficacy of Clinical SA Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the According to Protocol (ATP) Cohort.|Protective efficacy of clinical SA infection in the treatment compared to the control group during days 1-22 or until discharge, whichever occurs first using the ATP cohort. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the SA clinical infection to occur at the start of the interval, were still on study and had not yet had a SA clinical infection but were still being watched for the event. SA clinical infection was the development of a SA clinical infection due to an identifiable organism as evidenced by culture of an organism from a normally sterile body site or an infant who met the clinical diagnosis of localized infection as defined in the protocol. Censored participants were at risk for some of the interval, did not have a SA clinical infection but were removed from eligibility for the event at some point after the interval started.|Day 1 through 22|The ATP cohort includes all infants that have met all requirements of the mITT cohort, with the further requirements that infants in the mupirocin treatment group must have received a minimum of 10 complete mupirocin treatments, including at least one dose to all three NUP sites per day for five consecutive days during the treatment period.|||Participants|||Count of Participants
2633261|NCT01827358|Secondary|Protective Efficacy of Clinical S. Aureus (SA) Infection in the Treatment Compared to the Control Group During Days 1-22 or Until Discharge, Whichever Occurs First, Using the Intent to Treat Cohort.|Protective efficacy of clinical SA infection in the treatment compared to the control group during days 1-22 or until discharge, whichever occurs first using the intent to treat (ITT) cohort. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the SA clinical infection to occur at the start of the interval, were still on study and had not yet had a SA clinical infection but were still being watched for the event. SA clinical infection was the development of a SA clinical infection due to an identifiable organism as evidenced by culture of an organism from a normally sterile body site or an infant who met the clinical diagnosis of localized infection as defined in the protocol. Censored participants were at risk for some of the interval, did not have a SA clinical infection but were removed from eligibility for the event at some point after the interval started.|Day 1 through 22|The ITT cohort included all randomized infants. The analyses on the ITT cohort were performed per randomized treatment assignment.|||Participants|||Count of Participants
2633262|NCT01827358|Secondary|Median Time to Occurrence of Severe (Stage II-III) Necrotizing Enterocolitis (NEC) in the Treatment Compared to Control Group.|Median time to occurrence of severe (stage II-III) NEC in the treatment compared to control group as estimated using Kaplan-Meier estimates of the survival curves.|Day 1 through 85|There were no events of necrotizing enterocolitis during the study, analysis could not be performed.||||||
2633263|NCT01827358|Secondary|Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the According to Protocol Cohort.|Relative risk of occurrence of non-SA clinical infection in the treatment compared to control groups using the according to protocol (ATP) cohort. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the non-SA clinical infection to occur at the start of the interval, were still on study and had not yet had a non-SA clinical infection but were still being watched for the event. Non-SA clinical infection was the development of a non-SA clinical infection due to an identifiable organism as evidenced by culture of an organism other than SA from a normally sterile body site or an infant who met the clinical diagnosis of localized infection as defined in the protocol. Censored participants were at risk for some of the interval, did not have a non-SA clinical infection but were removed from eligibility for the event at some point after the interval started.|Day 1 through 85|The ATP cohort includes all infants with a site-specific pre-randomization NUP culture that is positive for SA by direct culture, those in the mupirocin treatment group must have received a minimum of 10 complete mupirocin treatments, including at least one dose to all three NUP sites per day for five consecutive days during the treatment period.|||Participants|||Count of Participants
2633264|NCT01827358|Secondary|Relative Risk of Occurrence of Non-SA Clinical Infection in the Treatment Compared to Control Group in the Intent To Treat Cohort|Relative risk of occurrence of non-SA clinical infection in the treatment compared to the control group using the intent to treat (ITT) cohort for analysis. The time periods in the table correspond to the study days having scheduled collection of nasal, umbilical, and perianal (NUP) cultures. At risk participants were eligible for the non-SA clinical infection to occur at the start of the interval, were still on study and had not yet had a non-SA clinical infection but were still being watched for the event. Non-SA clinical infection was the development of a non-SA clinical infection due to an identifiable organism as evidenced by culture of an organism other than SA from a normally sterile body site or an infant who met the clinical diagnosis of localized infection as defined in the protocol. Censored participants were at risk for some of the interval, did not have a non-SA clinical infection but were removed from eligibility for the event at some point after the interval started.|Day 1 through 85|The ITT cohort included all randomized infants. The analyses on the ITT cohort were performed per randomized treatment assignment.|||Participants|||Count of Participants
2633265|NCT01827358|Primary|Persistent Decolonization Efficacy- Number of Participants in the Treatment and Control Groups Who Have no Detectable S. Aureus (SA) on Direct Nasal, Umbilical, and Perianal (NUP) Cultures on Days 8 and 22.|Participants were admitted into the study based on being colonized with SA. Participants who were decolonized both on day 8 and day 22, as determined by NUP cultures were considered to have persistent decolonization. Colonization was defined as the presence of SA identified by NUP culture without signs of illness or infection. NUP swabs were collected on day 8 and on day 22 and cultured by direct plating. If the cultures were negative for SA at both day 8 and day 22 the participant was considered to have persistent decolonization. Colonization with SA was a prerequisite for enrollment, because of this there was no baseline measure.|Day 8 and Day 22|The analysis population included all infants with a site-specific pre-randomization NUP culture that was positive for SA by direct culture and who had either had complete sets of NUP cultures collected on day 8 and day 22 or else had discontinued NUP cultures prior to day 22 due to a clinical SA infection.|||Participants|||Count of Participants
2633266|NCT01827358|Primary|Primary Decolonization Efficacy- Number of Participants in the Treatment and Control Groups Who Have no Detectable S. Aureus (SA) on Direct Nasal, Umbilical, and Perianal (NUP) Cultures Obtained on Day 8.|Colonization was defined as the presence of SA identified by NUP culture without signs of illness or infection. On day 8, participants were swabbed in each of three areas: nasal, umbilical, and perianal. These swabs were cultured by direct plating. If SA did not grow on any of these cultures the infant was considered to be decolonized. If SA grew on any one of these cultures the infant was considered to be colonized with SA.|Day 8|The analysis population included all infants with a site-specific pre-randomization NUP culture that was positive for SA by direct culture and who either had a complete set of NUP cultures collected on Day 8 or else had discontinued NUP cultures prior to day 8 due to a clinical SA infection.|||Participants|||Count of Participants
2633280|NCT01827267|Secondary|Progression Free Survival (PFS)|Defined as time from date of randomization until the first disease recurrence or progression per RECIST V1.1 or death due to any cause; censored at the last assessable evaluation or at the initiation of new anti-cancer therapy. Disease assessment is based on investigator tumor assessments. If no post-baseline tumor assessment then censored at enrollment date.|From randomization to last tumor assessment, assessed up to 116.5 weeks. For the Neratinib arm, only tumor assessments prior to crossover were included.|All subjects who received at least 1 dose of drug|||months||95% Confidence Interval|Median
2633267|NCT01827358|Primary|Number of Participants With Serious Adverse Events (SAEs) During Days 1-7|Participants were evaluated for Serious Adverse Events (SAEs) while in the NICU/ICU on days 1-7. Although participants received only 5 days of mupirocin, SAEs were collected through day 7. An adverse event or suspected adverse reaction was considered serious if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: death; a life-threatening adverse event (an event that places the participant at immediate risk of death; it doesn't include an adverse event, had it occurred in a more severe form, might have caused death); inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; or any other event that when based upon appropriate medical judgement may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition.|Days 1 through 7|The analysis population was comprised of all infants, categorized according to treatment group. The number of infants is different from the overall study participant counts as 2 participants randomized to the mupirocin group received no mupirocin. For the purpose of safety analysis, these were included in the control (no mupirocin) group.|||Participants|||Count of Participants
2633268|NCT01827358|Primary|Number of Participants With Moderate and Severe Unsolicited Adverse Events; During Days 1-7|Participants were evaluated for moderate and severe unsolicited adverse events (that were not otherwise considered pre-defined trial endpoints) while in the NICU/ICU on days 1-7. Although participants received 5 days of mupirocin, unsolicited events were collected until day 7. Moderate events were defined as those that may cause some interference with functioning and daily activities. Severe events were defined as those that interrupt the participant's usual daily activities and may require systemic drug therapy or other treatment. Severe events were usually incapacitating.|Days 1 through 7|The analysis population was comprised of all infants, categorized according to treatment group. The number of infants is different from the overall study participant counts as 2 participants randomized to the mupirocin group received no mupirocin. For the purpose of safety analysis, these were included in the control (no mupirocin) group.|||participants||95% Confidence Interval|Number
2633269|NCT01827358|Primary|Number of Participants With Solicited Adverse Events (AEs) During Days 1-7|Participants were evaluated for solicited adverse events while in the NICU/ICU on days 1-7. Participants were counted if they experienced the symptom at any severity during the reporting period. Although participants received only 5 days of mupirocin, solicited events were collected through day 7.|Days 1 through 7|The analysis population was comprised of all infants, categorized according to treatment group. The number of infants is different from the overall study participant counts as 2 participants randomized to the mupirocin group received no mupirocin. For the purpose of safety analysis, these were included in the control (no mupirocin) group.|||participants|||Number
2633270|NCT01827332|Secondary|Marijuana Use (as Measured by Subjective Report of Number of Daily Smoking Sessions )|Subjects' marijuana use was measured via self-report of number of smoking sessions per day (Time Line Followback). The average number of daily sessions were calculated per group, with data presented below representing the change in amount of daily smoking sessions per group from first MET session to last MET session.|Self-report of average daily smoking sessions at MET Session 1 and last MET session 3||||daily smoking sessions||Standard Error|Mean
2633271|NCT01827332|Primary|Therapy Session Satisfaction (as Measured by Subjective Report)|After MET sessions, subjects completed the Session Rating Scale (SRS, Miller et al). This visual analog scale is comprised of 4 items for which participants rate their therapy experience in terms of relationship, goals and topics, approach/method, and overall, with minimum score 0 representing most dissatisfied and maximum score 10 representing most satisfied. Outcome measure reported below represents SRS score at last MET session.|Within 5 minutes of completing a 45-60 minute Motivational Enhancement Therapy (MET) session at last session visit||||units on a scale||Standard Error|Mean
2633272|NCT01827319|Secondary|2 CCS Angina Class Reduction|Canadian Cardiovascular Society (CCS) Angina Class-Class I: Ordinary physical activity does not cause angina, such as walking and climbing stairs. Angina with strenuous or rapid or prolonged exertion at work or recreation; Class II: Slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, or in cold, or in wind, or under emotional stress, or only during the few hours after awakening. Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions; Class III: Marked limitation of ordinary physical activity. Walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at normal pace; Class IV: Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest.|30 days||||participants|||Number
2633273|NCT01827319|Secondary|Major Adverse Cardiovascular Events (MACE) Rate, Defined as the Incidence of Cardiac-related Death, Myocardial Infarction (Q-wave and Non Q-wave), Congestive Heart Failure, Cerebrovascular Accident, and Serious Arrhythmia||30 days||||participants|||Number
2633274|NCT01827319|Primary|All Cause Mortality|Number of Participant Deaths|30 days||||participants|||Number
2633275|NCT01827306|Primary|Change From Baseline of Numeric Pain Rating Scale (NPRS)at 4 Weeks|The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain.|4 weeks||||units on a scale, from 0 to 10||Full Range|Mean
2633276|NCT01827306|Primary|Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 4 Weeks|The American Shoulder and Elbow Surgeons (ASES) Questionnaire is a self-report questionnaire measuring pain and disability. It is measured from 0 to 100, 0 being completely disabled and 100 being pain free and normal function. The total score is calculated using the following equation: (10-NPRS) x 5 = __ + (5/3) x Cumulative ADL Score|4 weeks||||units on a scale||Full Range|Mean
2633277|NCT01827306|Primary|Change From Baseline of Numeric Pain Rating Scale (NPRS) at 2 Weeks|The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain.|2 weeks||||units on a scale||Full Range|Mean
2633278|NCT01827306|Primary|Change From Baseline of American Shoulder and Elbow Surgeons (ASES) Questionnaire at 2 Weeks|The American Shoulder and Elbow Surgeons (ASES) Questionnaire is a self-report questionnaire measuring pain and disability. It is measured from 0 to 100, 0 being completely disabled and 100 being pain free and normal function. The total score is calculated using the following equation: (10-NPRS) x 5 = __ + (5/3) x Cumulative ADL Score|2 weeks||||units on a scale||Full Range|Mean
2633281|NCT01827267|Secondary|Duration of Response (DOR)|Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, progressive disease (PD), or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per RECIST (v1.1) criteria.|From randomization to last tumor assessment, assessed up to 116.5 weeks. For the Neratinib arm, only tumor assessments prior to crossover were included.|All subjects who received at least 1 dose of drug and had either complete or partial response.|||Participants|||Count of Participants
2633282|NCT01827267|Secondary|Clinical Benefit Rate (CBR)|CBR is defined as the proportion of patients who achieved objective response (CR or PR) or stable disease (SD) for at least 12 weeks.|From randomization to last tumor assessment, assessed up to 116.5 weeks. For the Neratinib arm, only tumor assessments prior to crossover were included.|All subjects who received at least one dose.|||Participants|||Count of Participants
2633283|NCT01827267|Primary|Objective Response Rate (ORR)|"ORR is defined as proportion of subjects who achieved confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~A complete or partial response must be confirmed no less than 4-weeks after the criteria for response are initially met."|From randomization to last tumor assessment, assessed up to 116.5 weeks. For the Neratinib arm, only tumor assessments prior to crossover were included.|All subjects who received at least 1 dose of drug|||Participants|||Count of Participants
2633284|NCT01827254|Primary|Progression Free Survival: Third Line Treatment|The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Third-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).|From start of treatment up to 23.7 months|"Evaluable population: All participants included in the analysis. Here “N” signifies number of participants who were analyzed for this outcome measure and n signifies those participants who were evaluable for respective treatment group."|||months||95% Confidence Interval|Median
2633285|NCT01827254|Primary|Progression Free Survival: Second Line of Treatment|The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease. Second-line treatment were divided in two groups: Group A (received treatment with: bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib) and Group B (received treatment with: temsirolimus, everolimus).|From start of treatment up to 22.9 months|"Evaluable population: All participants included in the analysis. Here “N” signifies number of participants who were analyzed for this outcome measure and n signifies those participants who were evaluable for respective treatment group."|||months||95% Confidence Interval|Median
2633286|NCT01827254|Primary|Progression Free Survival for Re-challenge With Sunitinib|The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease.|From start of treatment up to 52.2 months|Evaluable population: All participants included in the analysis. Here “N” signifies number of participants who were analyzed for this outcome measure.|||months||95% Confidence Interval|Median
2633287|NCT01827254|Other Pre-specified|Number of Participant With Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs include both serious as well as non-serious AEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to 24 months|Evaluable population: All participants included in the analysis.|||participants|||Number
2633288|NCT01827254|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target lesions, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Percentage of participants with objective response was calculated for the 1st-line of therapy with Sunitinib, Sunitinib re-challenge and for retreatment with Sunitinib as 3rd-line of therapy or more.|Baseline up to 98.0 months|Evaluable population: All participants included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2633289|NCT01827254|Secondary|Overall Survival|Overall survival of patients under treatment was evaluated by calculating the time between date of initiation of treatment (1st line) and date of death, if the latter occurred before the end of the study. Duration of Overall Survival =(Date of death - Start date of treatment) + 1)/365.25 x 12.|Baseline up to death or end of study (up to 98.0 months)|Evaluable population: All participants included in the analysis.|||months||95% Confidence Interval|Median
2633290|NCT01827254|Primary|Progression Free Survival With Sunitinib as First Line of Therapy|The PFS was defined as the time interval between the start date of treatment and the date of progression as assessed by the investigator or date of death occurring after treatment initiation, whichever occurred first. Duration of progression free survival= [(Date of mRCC progression - Start date of the treatment) + 1)]/ 365.25 x 12. Progression was defined as an increase in visible disease.|From start of treatment up to 66.6 months|Evaluable population: All participants included in the analysis.|||months||95% Confidence Interval|Median
2633292|NCT01827163|Primary|Number of Participants Who Are Able to Complete THL (Paclitaxel, Trastuzumab, and Lapatinib) Without a Dose Delay or Reduction, Grade 3 or Greater QTc Prolongation|The primary objective of this trial is to determine the feasibility of this regimen in patients with node-negative HER-2/neu overexpressed /amplified breast cancer with a tumor size of < 3 cm. The regimen is considered feasible if patients are able to complete the paclitaxel, trastuzumab, and lapatinib (THL) portion of the regimen without a dose delay or reduction or grade 3 or greater QTc prolongation.|1 year||||Participants|||Count of Participants
2633293|NCT01827046|Other Pre-specified|Mortality and Safety Events: Summary of AE and SAE by MedDRA Code and Grouped by Organ System Within the First 30 Days Post Ictus|By group comparison of the total number of adjudicated adverse events (AE) and serious adverse events (SAE) across all coded organ systems that occurred within the first 30 days post ictus.|Day 30||||Number of events|||Number
2633294|NCT01827046|Other Pre-specified|Mortality and Safety Events: Total Serious Adverse Events (SAE) at 30 Days|By group comparison of the total number of adjudicated serious adverse events that occurred within the first 30 days post randomization.|Day 30||||Number of events|||Number
2633295|NCT01827046|Other Pre-specified|Mortality and Safety Events: Adjudicated Bacterial Brain Infection|By group comparison of the percentage of subjects experiencing one or more adjudicated brain bacterial infection events within the first 30 days post randomization.|Day 30||||Participants|||Count of Participants
2633296|NCT01827046|Other Pre-specified|Mortality and Safety Events: Adjudicated Symptomatic Brain Bleeding Within 72 Hours After Last Dose|By group comparison of the percentage of subjects experiencing one or more adjudicated symptomatic brain bleeding events within the first 30 days post randomization.|72 hours after last dose||||Participants|||Count of Participants
2633297|NCT01827046|Other Pre-specified|Mortality and Safety Events: All Cause Mortality|By group comparison of mortality from all causes within the first 30 days post randomization.|Day 30||||Participants|||Count of Participants
2633298|NCT01827046|Other Pre-specified|Mortality and Safety Events: First-week (Operative) Mortality|Mortality and Safety events: By group comparison of mortality within the first 7 days post randomization.|Day 7||||Participants|||Count of Participants
2633299|NCT01827046|Secondary|EuroQol 5 Dimensional Scale (EQ-5D)|By group comparison of EQ-5D at day 365 post ictus. The EuroQol 5 Dimensional Scale (Eq-5D) is a self-reported measure of health status. It is arranged to assess domains related to mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each domain, codes were 1=no problems, 2=some problems, 3=extreme problems, and 9=unknown. Having a problem in at least 1 domain was coded as 1 (originally represented by 2 or 3) and no problems as 0 (originally represented by 1) .|Day 365|Patients were included if they survived or were not lost to followup through 365 days|||Participants|||Count of Participants
2633300|NCT01827046|Secondary|EQ-VAS|By group comparison of EQ-VAS at day 365 post ictus. The EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where subjects draw a line to indicate their health, with end points of 0 (the worst health you can imagine) and 100 (the best health you can imagine).|Day 365|Includes patients who survived or were not lost to followup through 365 days|||score on a scale||Inter-Quartile Range|Median
2633301|NCT01827046|Secondary|Type and Intensity of ICU Management: Hospital Days|By group comparison of total number of days in the hospital|Up to 365 days||||Days||Inter-Quartile Range|Median
2633302|NCT01827046|Secondary|Type and Intensity of ICU Management: ICU Days|By group comparison of cumulative number of days in the Intensive Care Unit (ICU) in a hospital|Up to 365 days|Includes patients with cumulative ICU days during the 365 days of follow-up|||Days||Inter-Quartile Range|Median
2633303|NCT01827046|Secondary|Dichotomized Extended Glasgow Outcome Scale (eGOS) Score UGR-US vs. LS-Death at 180 Days Post Ictus (Adjusted)|"Dichotomized, cross-sectional extended Glasgow Outcome Scale (eGOS) score upper good recovery (UGR) through upper severe disability (US) vs. lower severe disability (LS) through death at 180 days post ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep).~The eGOS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored as: 1=Death, 2=Vegetative state, 3=Lower severe disability, 4=Upper severe disability, 5=Lower moderate disability, 6=Upper moderate disability, 7=Lower good recovery, 8=Upper good recovery. Dichotomous variable coding is as follows: 1=codes 4-8, 0=codes 1-3."|Day 180|Patients were included if they were not lost to followup at day 180|||Participants|||Count of Participants
2633304|NCT01827046|Secondary|Dichotomized, Adjudicated, Cross-sectional Modified Rankin Scale (mRS) Score 0-3 vs. 4-6 180 Days Post Ictus (Adjusted)|"Dichotomized, adjudicated, cross-sectional modified Rankin Scale (mRS) score 0-3 vs. 4-6 at 180 days post-ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep).~The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death. Dichotomized scores are: 0-3=No symptoms to moderate disability requiring some assistance; 4-6=Moderately severe disability requiring complete assistance to death"|Day 180|Includes patients who were not lost to followup at day 180|||Participants|||Count of Participants
2633305|NCT01827046|Secondary|Patient Disposition: Patient Location at 365 Days Post Ictus (i.e., Good vs. Bad Location) (Adjusted)|"Patient disposition: By group comparison of residential location at day 365 post ictus adjusted for baseline severity.~Good locations refers to home and rehabilitation; and bad locations refers to acute care, long-term care and death."|Day 365||||Participants|||Count of Participants
2633306|NCT01827046|Secondary|Patient Disposition: Home Days Over 365 Days Time From Ictus.|By group comparison of cumulative days at home during the 365 days post ictus.|During 365 days of follow-up|Includes only patients with cumulative home days at any time during the 365 days of follow-up.|||Days||Inter-Quartile Range|Median
2633308|NCT01827046|Secondary|All Cause Mortality Longitudinally From Ictus to 365 Days (Adjusted)|By group comparison of mortality from ictus to 365 days adjusted for baseline severity.|Day 365||||Participants|||Count of Participants
2633309|NCT01827046|Secondary|Dichotomized Extended Glasgow Outcome Scale (eGOS) Score UGR-US vs. LS-Death at 365 Days Post Ictus (Adjusted)|"Dichotomized, cross-sectional extended Glasgow Outcome Scale (eGOS) score upper good recovery (UGR) through upper severe disability (US) vs. lower severe disability (LS) through death at 365 days post ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep).~The eGOS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored as: 1=Death, 2=Vegetative state, 3=Lower severe disability, 4=Upper severe disability, 5=Lower moderate disability, 6=Upper moderate disability, 7=Lower good recovery, 8=Upper good recovery. Dichotomous variable coding is as follows: 1=codes 4-8, 0=codes 1-3."|Day 365|Those with non-missing mRS scores at 365 days post ictus|||Participants|||Count of Participants
2633310|NCT01827046|Primary|Dichotomized, Adjudicated Modified Rankin Scale Score 0-3 vs. 4-6 at 365 Days Post Ictus (Adjusted)|"Dichotomized, adjudicated, cross-sectional modified Rankin Scale (mRS) score 0-3 vs. 4-6 at 365 days post-ictus, adjusting for baseline (pre-randomization) variables used in covariate adaptive randomization as well as the clinically established severity variables IVH size and ICH location (lobar or deep). Ictus refers to symptom onset.~The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death. Dichotomized scores are: 0-3=No symptoms to moderate disability requiring some assistance; 4-6=Moderately severe disability requiring complete assistance to death."|Day 365|Includes participants with mRS scores available at day 365. Number and proportions reported refer to number of participants and proportions with Modified Rankin Score 0-3|||Participants|||Count of Participants
2633311|NCT01826981|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2633312|NCT01826981|Secondary|Percentage of Participants With On-treatment Virologic Failure|"On-treatment virologic failure was defined as:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2633313|NCT01826981|Secondary|For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)||Posttreatment Weeks 16 and 20|Full Analysis Set included the participants who were randomized into Cohort 6 and received at least one dose of study drug.|||percentage of participants|||Number
2633314|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)||Posttreatment Weeks 2, 4, 8, and 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2633315|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Weeks 16, 20, and 24|Full Analysis Set|||percentage of participants|||Number
2633316|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Week 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2633317|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Week 10|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2633318|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Weeks 4, 6, and 8|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2633319|NCT01826981|Secondary|Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment||Weeks 1 and 2|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2633320|NCT01826981|Primary|Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)||Up to 24 weeks plus 30 days|Safety Analysis Set|||Percentage of participants|||Number
2633321|NCT01826981|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full analysis set: Participants who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2633322|NCT01826851|Secondary|Time to Return to Work or Daily Activities|Time to return to work or daily activities following surgery will be assessed at postoperative clinic follow up or during a follow up telephone interview.|36 days|Data was not collected on 15 participants in the Exparel arm and 17 participant in the Placebo arm.|||Days||Standard Deviation|Mean
2633323|NCT01826851|Secondary|Hospital Length of Stay (Days)|Duration of time spent in the hospital following surgery.|25 days||||Days||Inter-Quartile Range|Median
2633324|NCT01826851|Secondary|Time to First Bowel Movement (Days)|Time to first bowel movement following surgery.|35 days|Data was not collected on 3 participants in the Exparel arm and 1 participant in the Placebo arm.|||Days||Inter-Quartile Range|Median
2633325|NCT01826851|Secondary|ICU Length of Stay (Hours)|Duration of time spent in the intensive care unit postoperatively.|135 hours||||Hours||Inter-Quartile Range|Median
2633326|NCT01826851|Secondary|Time to Extubation (Hours)|Time to remove endotracheal tube following surgery.|77 hours||||Hours||Inter-Quartile Range|Median
2633327|NCT01826851|Primary|Median Pain Levels|The pain scores of the subjects in the Exparel group and placebo group were measured at 1,2,4,8,12,24,36,48,60, and 72 hours post-injection of Exparel or 0.9% normal saline. The pain scores were reported on a scale of 0 - 10. 0 being no pain. 10 being the worst pain.|Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.||||units on a scale||Inter-Quartile Range|Median
2633328|NCT01826851|Primary|Median Cumulative Morphine Equivalent|The cumulative opioid requirement is reported as morphine equivalent. The total amount of narcotics required by the subjects in the Exparel group and placebo group were measured at 1,2,4,8,12,24,36,48,60, and 72 hours post-injection of Exparel or 0.9% normal saline. The amounts were analyzed and are reported as morphine equivalents.|Outcome was measured at 1,2,4,8,12,24,36,48,60, and 72 hours post intercostal nerve block.||||Morphine Equivalents||Inter-Quartile Range|Median
2633329|NCT01826812|Secondary|Cytokines|Identification of various inflammatory cytokines in tear film of dry eye patients comparing to controls.|Tear samples were collected on the day of the exam. The samples were frozen to be assayed upon completion of the study.|The cytokine analysis was performed in the samples of selected participants based on their clinical signs and characteristics. The sample size of the groups was justified using the power analysis.|||pg/mL||Standard Error|Mean
2633330|NCT01826812|Secondary|Change in Visual Acuity||30 minutes||||logMAR||Standard Deviation|Mean
2633331|NCT01826812|Secondary|Change in Tear Osmolarity||Before and after 30 minutes reading||||mOsm/L||Standard Deviation|Mean
2633332|NCT01826812|Secondary|Change in Total Ocular Staining Score (OSS)|Ocular staining score (OSS) is sum of the corneal and conjuctival staining scores with a total possible maximum score of 12 for each eye. Corneal staining is graded with a maximum possible fluorescein score of 6 for each cornea (the punctate epithelial erosions grade between 0-3 plus any extra points for modifiers up to 3). Nasal and temporal conjunctiva are graded separately with a score range between 0 and 3 for each area after instillation of lissamine green. An abnormal OSS is defined as being a total score of 3 or more.|Before and after 30 minutes reading||||units on a scale||Standard Deviation|Mean
2633333|NCT01826812|Primary|Sustained Silent Reading Speed||30 minutes||||words/minute||Standard Deviation|Mean
2633334|NCT01826604|Secondary|Secondary Outcomes Will Include the Differences Between the Two Groups.|Secondary outcomes will include the duration of surgery or length of time from skin incision to delivery of the infant, change in hemoglobin, estimated blood loss, and postoperative length of stay, intra-operative or postoperative anti-emetic requirements, need for hospital readmission or emergency room visits, or other complication rates between the two groups.|From the time of surgery to 30 days post-op.|infection during 30 day postoperative period|||participants|||Number
2633335|NCT01826604|Primary|Wound Infection or Disruption|We will compare the number of patients with wound infections or disruptions when the Alexis O C-Section retractor is used vs when it is not used.|Time of surgery to 30 days post op|Any SSI or wound disruption during 30 day postoperative period|||participants|||Number
2633336|NCT01826513|Secondary|Number of Respiratory Event Related Arousals|Total number of respiratory event related arousals over the entire sleep period|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||Respiratory-Event Related Arousals||Standard Deviation|Mean
2633337|NCT01826513|Secondary|Percentage of Total Sleep Time Spent in Each Sleep Stage|Percentage of total sleep time spent in each sleep stage (ie. N1, N2, N3 and REM)|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||percentage of total sleep time||Standard Deviation|Mean
2633338|NCT01826513|Secondary|Oxygen Saturation|Oxygen saturation recorded in the total sleep time|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||percentage SpO2||Standard Deviation|Mean
2633339|NCT01826513|Secondary|Number of Central Apnoeas|Total number of central apnoeas occurring in the total sleep time|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||Central Apnoeas||Standard Deviation|Mean
2633340|NCT01826513|Secondary|Number of Obstructive Apnoeas|Total number of obstructive apnoeas occurring in the total sleep time|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||Obstructive Apnoeas||Standard Deviation|Mean
2633341|NCT01826513|Secondary|Number of Hypopnoeas|Total number of hypopnoeas occurring in the total sleep time|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||Hypopneas||Standard Deviation|Mean
2633342|NCT01826513|Secondary|Number of Spontaneous Arousals|Number of spontaneous arousals occurring over the entire total sleep time|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||Spontaneous Arousals||Standard Deviation|Mean
2633343|NCT01826513|Secondary|Time Taken to Fall Asleep|Time in minutes taken to fall alseep|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||minutes||Standard Deviation|Mean
2633344|NCT01826513|Secondary|Wake After Sleep Onset Time|Time awake in minutes after initial sleep onset|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||minutes||Standard Deviation|Mean
2633345|NCT01826513|Secondary|Sleep Efficacy|Sleep time divided by total time available for sleep|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||percentage of total recorded time||Standard Deviation|Mean
2633346|NCT01826513|Primary|Oxygen Desaturation Index (ODI)|Number of oxygen desaturations per hour of sleep|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||events/hour||Standard Deviation|Mean
2633347|NCT01826513|Primary|Apnoea Hypopnoea Index (AHI)|Number of apnoeas and hypopnoeas per hour of sleep|1 day|Reported results only include data from the blinded cross-over sequence arms (ie. Standard and Modified AutoSet algorithms). Data from the Unblinded Investigational phase of the trial was excluded as this phase was exploratory only to help refine the algorithm, and so, was not intended to be included in the final dataset.|||events/hour||Standard Deviation|Mean
2633348|NCT01826422|Secondary|Incorporation of EPA in the Erythrocytes|The percentage of EPA in the membrane of erythrocytes was determinated by gas chromatography.|Time Frame: At baseline, at 1, 2, 3, 4, 5, and 6||||percentage of change respect at basal||Full Range|Median
2633349|NCT01826422|Secondary|Incorporation of DHA in the Erythrocytes|The percentage of DHA in the membrane of erythrocytes was determinated by gas chromatography.|Time Frame: At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.||||percentage of change respect at basal||Full Range|Median
2633350|NCT01826422|Secondary|Markers of Muscle Regeneration (FGF)|Plasma marker of regeneration fibroblast growth factor basic (FGF) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Full Range|Median
2633351|NCT01826422|Secondary|Markers of Muscle Regeneration (VEGF)|Vascular endothelial growth factor (VEGF) was quantified using enzyme linked immunosorbent assay (ELISA).|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Full Range|Median
2633352|NCT01826422|Secondary|Markers of Muscle Degeneration (Receptor of Fas)|The concentration in plasma of the receptor o Fas (rFas) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.|At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Full Range|Median
2633353|NCT01826422|Secondary|Markers of Muscle Degeneration (sFas)|The concentration in plasma of soluble Fas (sFas) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Full Range|Median
2633354|NCT01826422|Secondary|Markers of Muscle Degeneration (MMP9)|Plasma matrix metalloproteinase 9 (MMP9) was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in ng/mL.|Time Frame: At baseline and at months 1, 2, 3 of supplementation.||||percentage of change respect at basal||Full Range|Median
2633355|NCT01826422|Secondary|Markers of Muscle Degeneration (Creatinine Kinase)|The concentration in serum of CK was determined by chemiluminescent immunometric assay in U/L.|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Standard Deviation|Mean
2633356|NCT01826422|Secondary|Inflammation Biomarker (IL-1 Expression)|The messenger ribonucleic acid (mRNA) expression of cytokines IL-1 was determined by quantifying the real-time polymerase chain reaction (PCR).|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Standard Deviation|Mean
2633357|NCT01826422|Secondary|Inflammation Biomarker (TNF-A Expression)|The messenger ribonucleic acid (mRNA) expression of cytokines TNF-A from circulating leucocytes was determined by quantifying the real-time polymerase chain reaction (PCR)|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Standard Deviation|Mean
2633358|NCT01826422|Secondary|Inflammation Biomarker (IL-6 Expression)|The messenger ribonucleic acid (mRNA) expression of cytokines IL-6 from circulating leucocytes was determined by quantifying the real-time polymerase chain reaction (PCR).|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Standard Deviation|Mean
2633359|NCT01826422|Secondary|Inflammation Biomarkers (IL-10)|Plasma cytokine IL-10 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Standard Deviation|Mean
2633360|NCT01826422|Secondary|Inflammation Biomarkers (IL-6)|Plasma cytokine IL-6 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.|Time Frame: At baseline and at months 1, 2, 3, and 6 of supplementation.||||percentage of change respect at basal||Standard Deviation|Mean
2633361|NCT01826422|Secondary|Inflammation Biomarkers (IL-1)|Plasma cytokine IL-1 was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Standard Deviation|Mean
2633362|NCT01826422|Secondary|Inflammation Biomarkers (TNF-A)|Plasma cytokine TNF-A was determined by enzyme-linked immunosorbent assay (ELISA) with a multiplex kit in picograms/mL.|Time Frame: At baseline and at months 1, 2, 3 and 6 of supplementation.||||percentage of change respect at basal||Standard Deviation|Mean
2633363|NCT01826422|Primary|Insulin in Blood|A fasting blood sample was taken; insulin was quantified utilizing a commercial kit, that is based on the radioimmunoanalysis method (RIA).|At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.||||µU/mL||Full Range|Median
2633364|NCT01826422|Primary|Glucose in Serum|A fasting blood sample was taken; serum glucose (mg/dL) levels were measured by the glucose-oxidase method.|At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.||||mg/dL||Full Range|Median
2633365|NCT01826422|Primary|Anthropometric Measurement: Body Mass Index|We measured weight, height by anthropometric to calculate the body mass index (body mass index).|At baseline and at months 1, 2, 3, 4, 5 and 6 of supplementation.||||g/m^2||Full Range|Median
2633368|NCT01826370|Secondary|Change From Baseline to Week 24 of Fasting Blood Sugar|Change from baseline to week 24 of fasting blood sugar|Baseline and 24 weeks|Effectiveness analysis set which included patients with complete baseline and follow up secondary outcomes. For this outcome measure this include patients with baseline and end-point data for fasting blood sugar.|||mg/dl||Standard Deviation|Mean
2633369|NCT01826370|Secondary|Change From Baseline to Week 24 of HbA1c|Change from baseline to week 24 of glycosylated hemoglobin (HbA1c)|Baseline and 24 weeks|Effectiveness analysis set which included patients with complete baseline and follow up secondary outcomes. For this outcome measure this include patients with baseline and end-point data for HbA1c.|||percentage of HbA1c||Standard Deviation|Mean
2633370|NCT01826370|Primary|Frequency of Adverse Events and Serious Adverse Events|Frequency of adverse events and serious adverse events in an actual clinical setting, including hypoglycemic events.|Week 24|Safety analysis set which consisted of all patients who have taken at least one dose of linagliptin and participated in the follow-up visit, thus, having a baseline and end-point evaluation.|||percentage of participants|||Number
2633371|NCT01826227|Primary|Sensitivity|of detection of lesions with PET probes compared to preoperative FDG18F-FDG PET and standard intraoperative examination. Sensitivity is defined as the percent of lesions that were found with malignant disease divided by the number of lesions with true presence of malignant disease based on the pathology report. A higher sensitivity will indicate a higher number of lesions found with the respective technique thus providing an initial estimate of the incremental benefit of the PET probe as opposed to the other techniques|2 years|Data not available because the PET probe failed.|||Participants|||Count of Participants
2633372|NCT01826214|Secondary|Parmacokintics (PK) Parameter: AUC0-24h|AUC0-24 is the area under the concentration-time curve from time zero to 24 hours done only on 800 mg once a day schedule. The PK parameters were determined in plasma using non-compartmental methods. A PK sample was excluded from analyses if the patient vomited within the first 4 hours following the last oral dose of study drug. Other PK samples were excluded as deemed appropriate by the Pharmacokineticist. AUC0-24h was derived from the PK concentrations collected at 0, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose on W1D1 and W9D1. The PK concentration at each time point is not an endpoint in the protocol, but these concentrations are used to derive the PK parameters.|Week 1 Day 1,Week 9 Day 1|Pharmacokinetic analysis set (PAS): consisted of all patients who received at least one dose of sonidegib and provided at least one evaluable PK blood sample.|||ng*hr/mL||Standard Deviation|Mean
2633373|NCT01826214|Secondary|Parmacokintics (PK) Parameter: AUC0-8h|AUC0-8h is the area under the concentration-time curve from time zero to 8 hours. The PK parameters were determined in plasma using non-compartmental methods. A PK sample was excluded from analyses if the patient vomited within the first 4 hours following the last oral dose of study drug. Other PK samples were excluded as deemed appropriate by the Pharmacokineticist. AUC0-8h was derived from the PK concentrations collected at 0, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose on W1D1 and W9D1. The PK concentration at each time point is not an endpoint in the protocol, but these concentrations are used to derive the PK parameters.|Week 1 Day 1,Week 9 Day 1|Pharmacokinetic analysis set (PAS): consisted of all patients who received at least one dose of sonidegib and provided at least one evaluable PK blood sample.|||ng*hr/mL||Standard Deviation|Mean
2633374|NCT01826214|Secondary|Parmacokintics (PK) Parameter: Tmax|Tmax is the time to reach Cmax. The PK parameters were determined in plasma using non-compartmental methods. A PK sample was excluded from analyses if the patient vomited within the first 4 hours following the last oral dose of study drug. Other PK samples were excluded as deemed appropriate by the Pharmacokineticist. Tmax was derived from the PK concentrations collected at 0, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose on W1D1 and W9D1. The PK concentration at each time point is not an endpoint in the protocol, but these concentrations are used to derive the PK parameters.|Week 1 Day 1,Week 9 Day 1|Pharmacokinetic analysis set (PAS): consisted of all patients who received at least one dose of sonidegib and provided at least one evaluable PK blood sample.|||hr||Inter-Quartile Range|Median
2633375|NCT01826214|Secondary|Parmacokintics (PK) Parameter: Cmax|Cmax is the maximum observed plasma concentration after drug administration.The PK parameters were determined in plasma using non-compartmental methods. A PK sample was excluded from analyses if the patient vomited within the first 4 hours following the last oral dose of study drug. Other PK samples were excluded as deemed appropriate by the pharmacokineticist. Cmax was derived from the PK concentrations collected at 0, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose on W1D1 and W9D1. The PK concentration at each time point is not an endpoint in the protocol, but these concentrations are used to derive the PK parameters.|Week 1 Day 1, Week 9 Day 1|Pharmacokinetic analysis set (PAS): consisted of all patients who received at least one dose of sonidegib and provided at least one evaluable PK blood sample.|||ng/mL||Standard Deviation|Mean
2633376|NCT01826214|Secondary|Overall Response Rate (ORR)|ORR was the rate of complete remission (CR), complete remission with incomplete blood count recovery (CRi) or partial response (PR) according to IWG criteria. CR, CRi or PR will be assessed through bone marrow biopsy/aspirate and peripheral blood blasts counts.|Every 8 weeks for the first 6 months and every 12 weeks until 53 weeks after the last patient is enrolled or until relapse up to 24 months|"Full analysis set (FAS): comprised of all patients who were randomized to a study treatment.~According to the intent-to-treat principle, patient data were analyzed according to the treatment to which they had been randomized."|||Participants|||Number
2633377|NCT01826214|Primary|Complete Remission With Incomplete Blood Count Recovery (CRi)|The other primary efficacy endpoint was CRi based on the International Working Group (IWG) criteria based on weekly peripheral blood count measurements and bone marrow biopsy/aspiration collection. Efficacy assessments were performed to determine CRi. A treatment cycle was defined as 4 weeks. No statistical analysis was planned for this primary outcome.|within 3 days after clearance of blasts from peripheral blood (PB), monthly thereafter until CR or reappearance of blasts in the PB, after CR every other month until discontination up to 24 months|"Full analysis set (FAS): comprised of all patients who were randomized to a study treatment.~According to the intent-to-treat principle, patient data were analyzed according to the treatment to which they had been randomized."|||Participants|||Number
2633394|NCT01825876|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of S-Warfarin||Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose|All participants who received a dose of study drug and had evaluable data for AUC(0-∞).|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2633378|NCT01826214|Primary|Rate of Complete Remission (CR)|Complete Response (CR) was based on the International Working Group (IWG) criteria based on weekly peripheral blood count measurements and bone marrow biopsy/aspiration collection. Efficacy assessments were performed to determine CR. A treatment cycle was defined as 4 weeks. The outcome measure for the study is based on standardized response criteria as defined by the International Working Group (IWG) for AML. The IWG was established by a group of investigators interested in the design and conduct of clinical trials in acute myeloid leukemia (AML). The criteria established by this group (a set of recommendations for response assessment) are well established, endorsed by major institutions and Health Authorities, and are widely used in clinical trials. No statistical analysis was planned for this primary outcome.|at screening, every week up to Week 9, every 2 weeks thereafter until CR, every 4 weeks after CR up to 24 months|"Full analysis set (FAS): comprised of all patients who were randomized to a study treatment.~According to the intent-to-treat principle, patient data were analyzed according to the treatment to which they had been randomized. No statistical analysis were reported in this study."|||Participants|||Number
2633379|NCT01826201|Secondary|Safety Assessment|Safety will be assessed based on reported adverse events, physical examination, vital signs, electrocardiograms, hematology, serum chemistry and urinalysis. Adverse events will be reported throughout the trial. Vital signs will be performed at screening, baseline, prior to the morning dose on Days 0, 1, 7, 14, 28, and at the follow up visit on Day 42. Physical examinations will be performed at Screening, baseline and Day 28. Hematology, serum chemistry and urinalysis will be performed at screening, baseline, Days 1, 7, 14, 28, and at the follow up visit on Day 42. ECGs will be performed at Screening, baseline and Day 28.|Baseline and Day 28|||||||
2633380|NCT01826201|Secondary|Change in EIS Area|Change in Erythema, Induration and Scale (EIS) area. Total score will be the EIS x Area, and will be calculated at baseline, Day 7, Day 14 and Day 28. The EIS will represent the sum of individual scores of Erythema, Induration and Scale using the same scale utilized in the PSS. The area of active erythema, induration and scale will be measured and the total scores will be calculated from the EIS scores multiplied by the area in cm2.|Baseline and Day 28|||||||
2633381|NCT01826201|Secondary|Treatment Success|Percent of patients achieving treatment success in the treatment group compared to the placebo group on day 28. Treatment success is defined as patient achieving a psoriasis severity score (PSS) of 3 or less, or an improvement of 5 points or more on the PSS.|Baseline and Day 28|||||||
2633382|NCT01826201|Secondary|Physician's Treatment Preference|The physician's treatment preference utilizing visual assessment and selection of the most improved plaque. The determination will be either 1)right lesion is preferred compared to left, 2)left lesion is preferred compared to right, 3) no difference between the right and left lesion.|Day 7, Day 14, Day 28|Per protocol|||participants|Participants||Number
2633383|NCT01826201|Secondary|Improvement in Lesion Appearance|Photography of the MOL4239 and placebo treated lesions will be performed at baseline, Day 7, Day 14 and Day 28 to assess for the improvement in lesion appearance after drug treatment. The assessment will be completed by a blinded panel of dermatologists experienced in the assessment of psoriasis.|Baseline and Day 28|||||||
2633384|NCT01826201|Primary|Mean Change From Baseline to Day 28 in PSS (Psoriasis Severity Score) of the Treatment Target Lesions Compared to Placebo Target Lesions|"he study drug application sites were scored for erythema, induration, and scale assessment using the PSS Scoring system. Psoriasis Severity Score (PSS) Erythema 0 - 4, 0 None, may have residual non-erythematous discoloration~1 Faint erythema 2 Moderate erythema/red color 3 Severe erythema/very red discoloration 4 Very severe erythema/extreme red coloration Induration 0 - 4 0 None~Trace or slight elevation of plaque above normal skin level~Moderate elevation with rounded or sloped edges to plaque~Marked elevation with hard, sharp edges to plaque~Very marked elevation with very hard, sharp edges to plaque Scaling 0 - 4~0 None~Fine scales~Coarse scales~Thick scales with a rough surface~Thick scales with a very rough surface~The scores were summed"|Baseline and Day 28||||PSS score|Participants|Standard Deviation|Mean
2633385|NCT01825941|Primary|Number of Participants With Sustained Headache Relief Assessed by Self-evaluation|"Sustained headache relief is defined as achieving a headache level of mild or none within two hours and maintaining a level of mild or none for 48 hours. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after discharge from emergency department"|up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department||||Participants|||Count of Participants
2633386|NCT01825889|Secondary|Pharmacokinetics (PK): Observed Maximum Concentration (Cmax) of Evacetrapib||Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdose|All participants who received evacetrapib and had evaluable Cmax data.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2633387|NCT01825889|Primary|Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of Evacetrapib||Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdose|All participants who received evacetrapib and had evaluable AUC(0-∞) data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2633388|NCT01825889|Primary|Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Time Zero To Time Tlast, Where Tlast is the Last Time Point With a Measurable Concentration (AUC[0-Tlast]) of Evacetrapib||Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdose|All participants who received evacetrapib and had evaluable AUC(0-Tlast) data.|||nanograms*hours/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2633389|NCT01825876|Secondary|PD: Maximum Observed INR Response (INRmax) of Warfarin|The INR is a standardized ratio of the PT, time it takes for blood to clot.|0, 6, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose on Days 1 and 17|All participants who received a dose of study drug and had evaluable data for INRmax.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2633390|NCT01825876|Secondary|Pharmacodynamics (PD): Area Under the International Normalized Ratio Curve (AUCINR) of Warfarin|The INR is a standardized ratio of the prothrombin time (PT), time it takes for blood to clot. AUCINR is the time curve used to measure change in INR over time.|Days 1 and 17: 0, 6, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose|All participants who received a dose of study drug and had evaluable data for AUCINR.|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
2633466|NCT01824446|Primary|Half-Life Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||hours||Standard Deviation|Mean
2633395|NCT01825837|Primary|Proportion of Patients Who Showed no Worsening According to the Clinical Global Impression - Bipolar Version (CGI-BP) Scale (Intent-to-Treat Population)|The CGI-BP scale is a modification of the CGI scale, which provides a means of assessing severity and treatment-related improvement in manic and depressive domains reflecting clinically relevant degrees of change. The concept of improvement refers to the clinical distance between the individual's current condition and that prior to the start of treatment. The scale for 'severity of illness' measures mania, depression and overall illness on a 7 point scale from 1 ('normal, not ill') to 7 ('very severely ill'). The scale for 'change from preceding phase' and 'change from worst phase' measures mania, depression, and overall illness on an 8-point scale from 1 (very much improved) to 8 ('not applicable'). If the patient, in 'change from preceding phase', at any visit during the double-blind, has a score of 5, 6, or 7 in any of 3 categories (mania, depression, or overall bipolar illness), then the illness will be considered to have worsened.|6 months||||participants|||Number
2633396|NCT01825798|Secondary|Changes in Fasting Metabolic Parameters (Insulin)||Baseline, 16 Weeks||||16-week change insulin fasting (µIU/mL)||95% Confidence Interval|Mean
2633397|NCT01825798|Secondary|Changes in Fasting Metabolic Parameters (Glucose)||Baseline, 16 Weeks||||16-week change in gluclose (mg/dL)||95% Confidence Interval|Mean
2633398|NCT01825798|Secondary|Changes in Fasting Metabolic Parameters (Triglycerides)||Baseline, 16 Weeks||||16-week change in triglycerides (mg/dL)||95% Confidence Interval|Mean
2633399|NCT01825798|Secondary|Changes in Fasting Metabolic Parameters (HDL)||Baseline, 16 Weeks||||16-week change in HDL (mg/dL)||95% Confidence Interval|Mean
2633400|NCT01825798|Secondary|Changes in Fasting Metabolic Parameters (LDL)||Baseline, 16 Weeks||||16-week change in LDL (mg/dL)||95% Confidence Interval|Mean
2633401|NCT01825798|Secondary|Changes in Fasting Metabolic Parameters (Total Cholesterol)||Baseline, 16 Weeks||||16-week change total cholesterol (mg/dL)||95% Confidence Interval|Mean
2633402|NCT01825798|Secondary|Changes in Additional Body Composition Parameters (Hip Circumference)||Baseline, 16 Weeks||||centimetres||95% Confidence Interval|Mean
2633403|NCT01825798|Secondary|Changes in Additional Body Composition Parameters (Abdominal Circumference)||Baseline, 16 Weeks||||centimetres||95% Confidence Interval|Mean
2633404|NCT01825798|Secondary|Changes in Additional Body Composition Parameters (Absolute BMI)||Baseline, 16 Weeks||||16-wk change in BMI (kg/m2)||95% Confidence Interval|Mean
2633405|NCT01825798|Secondary|Changes in Additional Body Composition Parameters (Relative Change in Weight)||Baseline, 16 Weeks||||16-wk change in weight (z-score)||95% Confidence Interval|Mean
2633406|NCT01825798|Secondary|Changes in Additional Body Composition Parameters (Absolute Change in Weight)||Baseline, 16 Weeks||||16-wk change in weight (kg)||95% Confidence Interval|Mean
2633407|NCT01825798|Primary|Change in Body Mass Index Z-score||Baseline, 16 Weeks||||16-wk change in BMI z-score||95% Confidence Interval|Mean
2633408|NCT01825785|Secondary|Change From Baseline in Ionized Calcium||Baseline and day 169 (or earlier for participants who discontinued before day 169)|Treated participants|||mg/dL||Standard Deviation|Mean
2633409|NCT01825785|Secondary|Percent Change From Baseline in Sclerostin||Baseline and days 15, 29, 43, 57, 71, 85, 99, 113, 127, 141, 155 and 169|Treated participants with available data at baseline and each time point|||percent change||Standard Error|Mean
2633410|NCT01825785|Secondary|Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)||Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169|Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.|||percent change||Standard Error|Mean
2633411|NCT01825785|Secondary|Percent Change From Baseline in Serum C-telopeptide (sCTX)||Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169|Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.|||percent change||Standard Error|Mean
2633412|NCT01825785|Secondary|Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP)||Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169|Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.|||percent change||Standard Error|Mean
2633413|NCT01825785|Secondary|Percent Change From Baseline in Osteocalcin||Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169|Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.|||percent change||Standard Error|Mean
2633414|NCT01825785|Secondary|Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP)||Baseline and days 2, 4, 6, 8, 15, 22, 29, 36, 43, 50 (Q2W only), 57, 58 (Q4W only), 60 (Q4W only), 62 (Q4W only), 64, 71, 72 (Q2W only), 74 (Q2W only), 76 (Q2W only), 78, 85, 99, 113, 127, 141, 155 and 169|Treated participants with available data at baseline and each time point; data were not collected on days 50, 72, 74, and 76 for Q4W cohorts or on days 58, 60, or 62 for Q2W cohorts.|||percent change||Standard Error|Mean
2633415|NCT01825785|Secondary|Percent Change From Baseline in Bone Mineral Density of the Whole Body|Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.|Baseline and days 29, 85, 127, and 169|Treated participants with available data at baseline and each time point|||percent change||Standard Error|Mean
2633416|NCT01825785|Secondary|Percent Change From Baseline in Bone Mineral Density at the Total Wrist|Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.|Baseline and days 29, 85, 127, and 169|Treated participants with available data at baseline and each time point|||percent change||Standard Error|Mean
2633467|NCT01824446|Primary|Tmax Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||hours||Full Range|Median
2633417|NCT01825785|Secondary|Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius|Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.|Baseline and days 29, 85, 127, and 169|Treated participants with available data at baseline and each time point|||percent change||Standard Error|Mean
2633418|NCT01825785|Secondary|Percent Change From Baseline in Bone Mineral Density at the Femoral Hip|Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.|Baseline and days 29, 85, 127, and 169|Treated participants with available data at baseline and each time point|||percent change||Standard Error|Mean
2633419|NCT01825785|Secondary|Percent Change From Baseline in Bone Mineral Density at the Total Hip|Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans and assessed by a central lab.|Baseline and days 29, 85, 127, and 169|Treated participants with available data at baseline and each time point|||percent change||Standard Error|Mean
2633420|NCT01825785|Secondary|Percent Change From Baseline in Bone Mineral Density of the Total Spine|Bone mineral density was determined by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and assessed by a central lab.|Baseline and days 29, 85, 127, and 169|Treated participants with available data at baseline and each time point|||percent change||Standard Error|Mean
2633421|NCT01825785|Secondary|Accumulation Ratio (AR) for Romosozumab|The accumulation ratio (AR) was calculated as the ratio of AUC0-tau after the last dose to AUC0-tau after the first dose.|Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.|All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.|||ratio||Standard Deviation|Mean
2633422|NCT01825785|Secondary|Half-life Associated With the Terminal Phase of Elimination (T1/2) for Romosozumab||Q2W dose groups: days 71 (predose) to 169; Q24 dose groups: days 57 (predose) to 169.|All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.|||days||Standard Deviation|Mean
2633423|NCT01825785|Secondary|Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab|Area under the serum romosozumab concentration-time curve from time 0 to tau (tau = 14 days for Q2W dose cohorts and 28 days for Q4W dose cohorts)|Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.|All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.|||μg*day/mL||Standard Deviation|Mean
2633424|NCT01825785|Secondary|Maximum Observed Concentration (Cmax) of Romosozumab||Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.|All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.|||μg/mL||Standard Deviation|Mean
2633425|NCT01825785|Secondary|Time to Maximum Observed Concentration (Tmax) of Romosozumab|Serum concentrations of romosozumab were measured by a validated enzyme-linked immunosorbent assay; the lower limit of quantification (LLOQ) was 50 ng/mL.|Q2W dose groups: First dose on days 1 (predose) to 15 (predose); Last dose on days 71 (predose) to 169. Q4W dose groups: First dose on days 1 (predose) to 29 (predose); Last dose on days 57 (predose) to 169.|All participants who received romosozumab and for whom the pharmacokinetic parameter could be adequately estimated.|||days||Full Range|Median
2633426|NCT01825785|Primary|Number of Participants Who Developed Antibodies to Romosozumab|"All samples were tested for binding anti-romsozumab antibodies using an immunoassay; all antibody-positive samples were further tested in a bioassay to determine if the antibodies were neutralizing.~Development of antibodies to romosozumab is defined as participants with a negative result at baseline and a positive result at any time postbaseline."|Blood samples for detection of anti-romosozumab antibodies were collected at day 1 (predose) and days 29 (predose), 57 (predose), 85, 113, 141, and 169.|All treated participants|||Participants|||Count of Participants
2633427|NCT01825785|Primary|Number of Participants With Adverse Events|"Serious adverse events were any events that were fatal, were life-threatening (placed the participant at immediate risk of death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, were congenital anomalies or birth defects, or were other significant medical hazards.~Relatedness to investigational product was assessed by the investigator by means of the question: Is there a reasonable possibility that the event may have been caused by the investigational product?'"|169 days|All treated participants|||Participants|||Count of Participants
2633428|NCT01825655|Primary|Change in Itch Score|Itch score will be used to analyze our primary outcome. The subjects will have an itch score at baseline and compared to itch score at 3hrs post intervention. Itch score is measured on a scale of 1 to 4, with lower scores indicating less itchiness.|Baseline to 3 hours|No participants were randomized into the cetirizine arm|||units on a scale||Full Range|Mean
2633429|NCT01825577|Secondary|POMA -Performance Oriented Mobility Assessment - Measure of Gait and Balance.|Performance Oriented Mobility Assessment (POMA), used to measure subject's ability to maintain balance. The test takes 10-15 minutes and involves asking subject to stand from a sitting position, standing with eyes closed and sitting down. POMA total score has a range of 0-36 where higher scores represent better performance. POMA total score is an additive combination of the 12 point Gait sub-score and the 16 point balance sub-score. A cut-off score of <21 is generally considered a fall risk among elderly people.|4 weeks|Elderly patients living in community nursing homes identified as fall risk with a diagnosis of probable Alzheimer's Disease.|||Units on a scale||Standard Deviation|Mean
2633430|NCT01825577|Primary|Timed Get Up and Go Test - Measure of Mobility|Timed Get Up and Go Test (TUG), is used to evaluate the ability to walk by measuring the time it takes to rise from a chair, walk 10 feet, turn around, walk back to the chair, and sit down. The TUG test takes less than 5 minutes to complete. Scored as seconds required to complete the task.|Baseline and Post-test at 4 weeks|Elderly patients living in community nursing homes identified as fall risks with a diagnosis of probable Alzheimer's disease.|||seconds||Standard Deviation|Mean
2633468|NCT01824446|Primary|Cmax Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||ng equivalents/ml||Standard Deviation|Mean
2633469|NCT01824446|Primary|AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||ng equivalents*hr/ml||Standard Deviation|Mean
2633431|NCT01825408|Primary|Number of Patients Recommended for Sinus Surgery After 6 Weeks of Antibiotic Therapy|Recommendation for sinus surgery after completion of maximal medical therapy is determined by the subject's treating physician and is based on two citeria: (1) persistence of symptoms and (2) objective evidence of disease on post-treatment sinus CT scan or nasal endoscopy. Symptomatic improvement of sinusitis symptoms will be assessed by: patient self report, change in Chronic Sinusitis Survery (CSS) score and change in RhinoSinusitis Disibility Index (RSDI) score relative to initial pre-antibiotic CSS and RSDI survey scores.|7-8 weeks after initiating antibiotics||||Participants|||Count of Participants
2633432|NCT01825408|Primary|Number of Patients Recommended for Sinus Surgery After 3 Weeks of Antibiotic Therapy|Recommendation for sinus surgery after completion of maximal medical therapy is determined by the subject's treating physician and is based on two citeria: (1) persistence of symptoms and (2) objective evidence of disease on post-treatment sinus CT scan or nasal endoscopy. Symptomatic improvement of sinusitis symptoms will be assessed by: patient self report, change in Chronic Sinusitis Survery (CSS) score and change in RhinoSinusitis Disibility Index (RSDI) score relative to initial pre-antibiotic CSS and RSDI survey scores.|4-5 weeks after starting antibiotics||||Participants|||Count of Participants
2633433|NCT01825200|Secondary|Subjects With at Least One Hypersensitivity Event Reported on Day 0 and Days 0-7 Following Vaccine Administration as a Measure of Safety|Subjects with at least one pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or non-dependent edema on Day 0 and for Days 0 to 7 following vaccine administration|7 Days|The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.|||participants|||Number
2633434|NCT01825200|Secondary|Number of Participants With Local and Systemic Events Reported as a Measure of Safety|Number of solicited local and systemic events of reactogenicity reported with the help of a memory aid during the seven days following vaccine administration.|7 Days|The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.|||participants|||Number
2633435|NCT01825200|Secondary|Subjects With at Least One Unsolicited Adverse Event in the 30 Days Following Vaccine Administration|Subjects with at least one serious adverse event and subjects with at least one medically-attended unsolicited adverse event occurring during the 30 days following vaccine administration|30 Days|The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.|||participants|||Number
2633436|NCT01825200|Primary|Number of Participants With Common Hypersensitivity Reactions as Measure of Safety|Number of participants who experience a pre-defined common systemic hypersensitivity adverse event, including rash, urticaria, swelling or edema through Day 30 post-vaccine administration.|30 Days|The primary analysis population, includes all randomized subjects who received a dose of study vaccine and for whom some safety data were available after administration of vaccine. Subjects were analyzed according to the vaccine received, regardless of whether this was the treatment group to which they were randomized.|||participants|||Number
2633437|NCT01825122|Primary|Change From Baseline in the Average Number of Cigarettes Smoked Per Day||Baseline to end of treatment, up to 15 weeks|The analysis population reflects all patients who achieved maintenance dosing, including those who did not complete the study|||participants|||Number
2633438|NCT01824979|Secondary|Number of Mask Interventions During the Night|Sleep technicians reported the number of times they had to intervene with the mask to get a good seal or improve comfort.|One night|While not all participants completed the full study, a number of participants had completed enough of the study to provide data to analyze. For this outcome measure, 48 participants in the Pilairo Group had usable data for analysis while 42 participants in the Other CPAP mask group had usable data for analysis for this measure.|||units on a scale||Full Range|Mean
2633439|NCT01824979|Primary|Technician Experience With Mask|Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience.|One night|While not all participants completed the full study, a number of participants had completed enough of the study to provide data to analyze. For this outcome measure, 48 participants in the Pilairo Group had usable data for analysis while 42 participants in the Other CPAP mask group had usable data for analysis for this measure.|||Units on a Scale||Full Range|Mean
2633440|NCT01824901|Primary|Maximum Tolerated Dose (MTD) of FGFR Inhibitor AZD4547|A total of 3 dose levels of AZD4547 were planned: 40mg (level 1), 60mg (level 2), and 80mg (level 3) in combination with a standard dose of docetaxel (75mg/m^2). The starting dose level of AZD4547 was 40 mg. This portion of the study used a standard 3+3 design with patients enrolled in cohorts of 3. The plan was to recommend the maximum tolerated dose (MTD) as the dose level to be used in the phase II portion of the study. MTD is defined as the highest dose level at which less than or equal to 1 of 6 subjects experience dose limiting toxicity (DLT).|Assessed during cycle 1 (21 days)||||mg|||Number
2633441|NCT01824823|Primary|Disease-free Survival (DFS)|DFS is defined as the time from randomization to the earlier of disease recurrence, second primary cancer, or death without recurrence.|Assessed every 3 months for patients < 2 years from registration and every 6 months if patient is 2-3 years from registration and every 12 months if patient is 4-5 years from registration|All randomized patients|||months||95% Confidence Interval|Median
2633442|NCT01824693|Secondary|Percent Probability of 18 Months-relapse Event Between Arms|Probability of patients relapsing at 18 months. A relapse event is defined in protocol section 10.2.3. Time to relapse/non-response is defined as time from transplant to when all criteria of section 10.2.3 are met.|From transplant up to 18 months|All eligible randomized patients|||percent probability||95% Confidence Interval|Number
2633470|NCT01824446|Primary|Vz/F Whole Blood Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||Liters||Standard Deviation|Mean
2633471|NCT01824446|Primary|CL/F Whole Blood Total Radioactivity of Radio-Labelled SSP-004184||Up to 288 hours post-dose|PAS|||L/hr||Standard Deviation|Mean
2633443|NCT01824693|Secondary|Percentage of Participants Who Experience Primary Graft Failure Event Between Arms|Primary Graft failure is defined as the failure to achieve an ANC >= 500/uL after 42 days, determined by 3 consecutive measurements on different days; OR < 5% donor cells in blood or bone marrow by day +42 (as demonstrated by a chimerism assay), without evidence of Juvenile Myelomonocytic Leukemia (JMML).|Day 0 - day 540 (18 months) following completion of stem cell transplant|All Eligible randomized patients|||percentage of patients|||Number
2633444|NCT01824693|Primary|Number of Participants Who Experience Treatment-Related Mortality (TRM) by Day 100|The number of patients who experience TRM on day 100. Treatment-Related Mortality (TRM) an event defined as a death prior to relapse or non-response. Time to TRM is defined as time from transplants to TRM. Patients who die between the start of the conditioning regimen and transplant will be considered a TRM with time to TRM of zero.|From transplant up to 100 days|All eligible randomized patients|||Participants|||Count of Participants
2633445|NCT01824693|Primary|Percent Probability of Event-free Survival (EFS)|Probability of Event-free Survival (EFS) for Patients after 18 months. An event is either treatment related mortality (TRM), primary or secondary graft failure, or relapse/non-response (as defined in protocol section 10). Time to event is time from transplant with patients who die between the start of the conditioning regimen and transplant given a time to event of zero.|From transplant up to 18 months|All eligible randomized patients|||percent probability||95% Confidence Interval|Number
2633446|NCT01824602|Primary|Change in Young Mania Rating Scale (YMRS) Total Score From Baseline Until the End of the 3-week Treatment Period|The YMRS is used to assess disease severity in patients who have been previously diagnosed with mania and it has proven psychometric properties through 11 item multiple-choice diagnostic questionnaire and the total score is determined from the summation of each 11 individual scores (and can range from 0 - 60) based on the patient's subjective feedback of his clinical condition over the previous 48 hours. A higher score indicates a worse rating for symptoms related to mania. At every visit throughout the study, investigators administered the YMRS. The results of the primary analysis of efficacy were calculated using Analysis of covariance (ANCOVA) with Last Observation Carried Forward (LOCF). Primary variable is presented through ANCOVA results for absolute change in YMRS total score from baseline (V2) to end of treatment (V7). A responder has at least 50% improvement (reduction) in the YMRS total score or has a total score of less than 12 points at the end of treatment period.|baseline and 3-week|The ITT efficacy population of 37 patients consisted of all randomised patients who received at least one dose of investigational product and at least 1 post-baseline YMRS assessment. If a patient discontinues before the end of the 3-week treatment period then the last observation will be carried forward (LOCF).|||units on a scale||Standard Error|Mean
2633447|NCT01824589|Secondary|Arterial Blood Gases (PaCO2)|Arterial blood gases will be collected.|15 minutes after device activation||||mmHg|||Number
2633448|NCT01824589|Secondary|Lung Compliance|Change in lung compliance following each ITPR treatment compared to baseline.|baseline and immediately after device removal||||ml/cmH2O|||Number
2633449|NCT01824589|Secondary|Cerebral Perfusion Pressure (CPP)|Measurement of the difference between baseline CPP and CPP at 15 minutes|15 minutes after device activation||||mmHg|||Number
2633450|NCT01824589|Primary|Intracranial Pressure (ICP)|Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use.|15 minutes after device is activated||||mmHg|||Number
2633451|NCT01824576|Secondary|Change From Baseline in Oxygen Saturation (SpO2)|Measure change in SpO2 average during baseline and 15 minutes following removal of the ITPR|basseline to 15 minutes following device use||||percentage of saturation||Standard Deviation|Mean
2633452|NCT01824576|Secondary|Change From Baseline in End-tidal Carbon Dioxide (EtCO2)|Measure change in EtCO2 average during baseline and 15 minutes following removal of the ITPR|baseline to 15 minutes following device use||||mmHg||Standard Deviation|Mean
2633453|NCT01824576|Secondary|Change From Baseline in Pulse Pressure (PP)|Measure change in pulse pressure average during baseline and 15 minutes following removal of the ITPR|baseline to 15 minutes following device use||||mmHg||Standard Deviation|Mean
2633454|NCT01824576|Secondary|Change From Baseline in Heart Rate (HR)|Measure change in heart rate average during baseline and 15 minutes following removal of the ITPR|baseline to 15 minutes following device use||||beats/min||Standard Deviation|Mean
2633455|NCT01824576|Secondary|Change From Baseline in Mean Arterial Pressure (MAP)|Measure change in mean arterial pressure average during baseline and 15 minutes following removal of the ITPR|baseline to 15 minutes following device use||||mmHg||Standard Deviation|Mean
2633456|NCT01824576|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP)|Measure change in diastolic blood pressure average during baseline and 15 minutes following removal of the ITPR|baseline to 15 minutes following device use||||mmHg||Standard Deviation|Mean
2633457|NCT01824576|Secondary|Change From Baseline in PaCO2|PaCO2 will be collected during baseline and 15 minutes after device activation and change will be evaluated.|baseline and 15 minutes after device activation|PaCO2 values for comparison were not available for two subjects|||mmHg||Standard Deviation|Mean
2633458|NCT01824576|Secondary|Change From Baseline in Systolic Blood Pressure (SBP)|Measure change in systolic blood pressure average during baseline and 15 minutes following removal of the ITPR|baseline to15 minutes following device use||||mmHg||Standard Deviation|Mean
2633459|NCT01824576|Primary|Change From Baseline in Cerebral Perfusion Pressure (CPP)|Change from average baseline CPP compared with the average CPP during use of the ITPR.|During 120 minutes of device use||||mmHg||Standard Deviation|Mean
2633460|NCT01824498|Primary|E2|Estradiol|8 weeks||||pmol/L||Standard Error|Least Squares Mean
2633461|NCT01824498|Primary|Plasma Sex Hormone Levels||8 weeks|||||||
2633462|NCT01824446|Primary|Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||percentage of radioactivity||Standard Deviation|Mean
2633463|NCT01824446|Primary|Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||percentage of radioactivity||Standard Deviation|Mean
2633464|NCT01824446|Primary|Vz/F Plasma Total Radioactivity of Radiolabelled SSP-004184||Up to 288 hours post-dose|PAS|||Liters||Standard Deviation|Mean
2633465|NCT01824446|Primary|CL/F Plasma Total Radioactivity of Radio-Labelled SSP-004184||Up to 288 hours post-dose|PAS|||L/hr||Standard Deviation|Mean
2633480|NCT01824446|Primary|Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-004184|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Up to 288 hours post-dose|PAS|||ng/ml||Standard Deviation|Mean
2633481|NCT01824446|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-004184|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Up to 288 hours post-dose|The Pharmacokinetic Analysis Set (PAS) was defined as all subjects in the Safety Analysis Set (SAS) for whom the primary pharmacokinetic data are considered sufficient and interpretable. The SAS consisted of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||ng*hr/ml||Standard Deviation|Mean
2633482|NCT01824394|Primary|Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population|The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs|30 days post-procedure|The Intent-to-Treat and As-Treated population which includes randomized patients who have the ablation catheter inserted|||Participants|||Count of Participants
2633483|NCT01824394|Primary|Number of Participants With Early Onset Primary Adverse Events|The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs|30 days post-procedure|Safety Population|||Participants|||Count of Participants
2633484|NCT01824355|Secondary|Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements|Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree.'|1 hour|Four subjects of those enrolled (113 subjects) had either missing or unevaluable questionnaire data.|||participants|||Number
2633485|NCT01824355|Secondary|Percent of Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method When Tested by Study Staff|Study Staff tested subject fingerstick blood using the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <75mg/dL) and within +/- 20% (for reference BG results >=75mg/dL) of the YSI reference method results.|one hour|220 Blood Glucose results were analyzed. Study Staff provided 2 Blood Glucose Test Results from each subject who completed (110 subjects) the study.|||percentage of Blood Glucose Results|Participants||Number
2633486|NCT01824355|Secondary|Percent of Blood Glucose Results From Alternative Site Testing (AST) of the Palm Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Method.|Untrained subjects with diabetes self-tested Alternative Site (AST) Palm blood using the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS AST results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) and within +/- 15% (>=75mg/dL YSI capillary plasma).|1 hour|209 (220-11) Blood Glucose results were analyzed. 2 subjects had low blood sugar and per protocol their 4 AST BG results were not evaluable. 3 BG results were excluded as they were protocol deviations. One subject (2 BG results) did not complete testing within protocol timeframe and one subject (2 BG results) was unable to obtain AST blood.|||percentage of AST Blood Glucose Results|Participants||Number
2633487|NCT01824355|Secondary|Percent of Self Test Fingerstick Blood Glucose Results Within ±12.5 mg/dL (< 100 mg/dL) and Within ±12.5% (≥ 100 mg/dL) of the Laboratory Glucose Method|Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 12.5mg/dL (for reference BG results <100mg/dL) and within +/- 12.5% (for reference BG results >=100mg/dL) of the YSI reference method results.|1 hour|220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results.|||percentage of Blood Glucose Results|Participants||Number
2633488|NCT01824355|Secondary|Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 100 mg/dL) and Within ±15% (≥ 100 mg/dL) of the Laboratory Glucose Method|Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <100mg/dL) and within +/- 15% (for reference BG results >=100mg/dL) of the YSI reference method results.|1 hour|220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results.|||percentage of Blood Glucose Results|Participants||Number
2633489|NCT01824355|Primary|Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method|Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <75mg/dL) and within +/- 20% (for reference BG results >=75mg/dL) of the YSI reference method results.|1 hour|220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results.|||percentage of BG results|Participants||Number
2633637|NCT01822548|Primary|Absolute Change in the Endothelial Progenitor Cell (EPC) Number|The study primary endpoint was the change from baseline values of the EPC number in the Vildagliptin vs Glibenclamide arm at 4 and 12 months.|V0, V2 (month 4), V4 (12 month)|Intention to treat (ITT) analysis|||EPC/10^6 cells||Inter-Quartile Range|Median
2633490|NCT01824342|Secondary|Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|A scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work); 2 = Ambulatory and capable of all self care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry out any self-care. Totally confined to bed or chair; 5 = Dead.|Baseline and Week 49|Safety analysis set with available data at both time points|||participants|||Number
2633491|NCT01824342|Primary|Number of Participants With Anti-denosumab Neutralizing Antibody Formation||3 years|Participants exposed to open-label denosumab with ≥ 1 antibody sample|||participants|||Number
2633492|NCT01824342|Primary|Percent Change From Baseline in Laboratory Values||Baseline and Week 49|Safety analysis set with available laboratory data at each time point.|||percent change||Standard Deviation|Mean
2633493|NCT01824342|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs) and Deaths|A serious adverse event is defined as an adverse event that meets at least one of the following serious criteria: • fatal, • life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other significant medical hazard. The adverse event severity grading scale used was the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, according to the following: Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE. The investigator assessed whether each adverse event was possibly related to the investigational product (IP).|From the first dose of open-label denosumab until 4 weeks after the last; maximum time on study was 37 months. Follow-up survival information was collected for up to 3 years after the last dose of blinded investigation product in the 20050147 study.|Safety analysis set, which included participants who had properly documented informed consent for protocol 20080585 and received at least 1 dose of open-label denosumab.|||participants|||Number
2633494|NCT01824303|Secondary|Change From Baseline in Brief Pain Inventory (BPI)|The BPI is a 7-item participant completed questionnaire. The participant answered questions as to how pain interfered with: General Activity, Mood, Walking Ability, Normal work, Relations with other people, Sleep and Enjoyment of life. Questions were answered on an 11-point scale where: 0=Does not interfere to 10=Completely interferes. The total score is the average of the individual questionnaire items for a total possible score of 0 (best) to 10 (worst). A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.|||score on a scale||Standard Deviation|Mean
2633495|NCT01824303|Secondary|Change From Baseline in Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)|The BPIC-SS is a participant reported questionnaire consisting of 8 items. Questions (Q) 1-5 (How often urination because of pain; Need to urinate after just urinating; How often urination to avoid worse pain; How often feeling of pressure in bladder; How often pain in bladder) answered on a 5-point scale where: 0=Never to 4=Always. Q 6-7 (Bothered by frequent Day-time urination; Bothered by Night-time urination) answered on a 5-point scale where: 0=Not At All to 4=A Great Deal. Q8 (pain) rated on a NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. The Total Score is the sum of the individual questionnaire of all 8 items for a total possible score of 0 (best) to 38 (worst). A negative change indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.|||score on a scale||Standard Deviation|Mean
2633496|NCT01824303|Secondary|Change From Baseline in O'Leary-Sant Interstitial Cystitis Problem Index (ICPI) Score|The ICPI is a participant reported questionnaire to rate their problems in the following 4 areas: Frequent urination; Getting up at Night to Urinate: Urination with little warning; Burning pain and discomfort. Questions are answered on a 5-point scale where: 0=No Problem to 4=Big Problem. The total score is the sum of the individual scores for a total possible score of 0 (best) to 20 (worst). A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.|||score on a scale||Standard Deviation|Mean
2633497|NCT01824303|Secondary|Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score|The ICSI is a participant reported questionnaire to rate their symptoms by answering 4 questions. Question (Q) 1 and 2 (urine urgency) using a 6-point scale where: 0=Not at All to 5=Almost Always. Q3 (night-time voids) using a 6-point scale where: 0=None to 5=5 or More Times. Q4 (pain and burning) using a 6-point scale where: 0=Not at All to 5=Usually. The total score is the sum of the individual scores for a total possible score of 0 (best) to 20 (worst). A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.|||score on a scale||Standard Deviation|Mean
2633498|NCT01824303|Secondary|Change From Baseline in Post-Void Bladder Pain|Participants rated their bladder pain immediately completing voiding in an electronic diary using a horizontal line NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. The average of the data from the first 5 voids prior to Baseline and the 3 days prior to Day 12 were averaged for analyses. A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.|||units on a scale||Standard Deviation|Mean
2633499|NCT01824303|Secondary|Change From Baseline in Average Void Volume Per Micturition|Participants recorded the amount of each void in millimeters (mL) in an electronic diary. The total amount of void per micturition (each void) was averaged over a period of 24 days. A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.|||mL||Standard Deviation|Mean
2633500|NCT01824303|Secondary|Change From Baseline in Night-Time Daily Voids|Participants recorded number of night-time daily voids in a 3 day Voiding Frequency electronic diary. The total number of night-time daily voids was averaged over a period of 3 days. A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.|||voids||Standard Deviation|Mean
2633501|NCT01824303|Secondary|Change From Baseline in Total Daily Voids|Participants recorded number of daily voids (day-time and night-time daily voids) in a 3 day Voiding Frequency electronic diary. The total number of daily voids was averaged over a period of 3 full days. A negative change from Baseline indicates improvement.|Baseline, Day 27|Participants from the ITT population, all randomized participants, with data available for analyses.|||voids||Standard Deviation|Mean
2633502|NCT01824303|Primary|Change From Baseline in Participant Reported Average Bladder Pain on a Numerical Rating Scale (NRS)|Participants rated their bladder pain over the previous 24 hours in an electronic diary using a horizontal line NRS by putting a mark on the line where: 0 (the far left of the line)=no pain to 10 (far right of the line)=worst pain imaginable. Bladder pain was averaged over a period of 3 days. A negative change from Baseline indicates improvement.|Baseline, Day 12|Intent-to-treat (ITT) population included all randomized participants.|||unit on a scale||Standard Deviation|Mean
2633503|NCT01824290|Secondary|Period 2: Percentage of Participants Who Experience CW|Clinical worsening was defined as any of the following: death, lung or heart transplantation, atrial septostomy or Potts' shunt, hospitalization for Pulmonary Arterial Hypertension (PAH) progression, new onset syncope, initiation of new PAH therapy (including increase in the dose of existing PAH specific concomitant therapy, such as endothelin receptor agonist or beraprost medication), or increase of 1 or more in World Health Organization(WHO) Functional Class (except for participants already in Class IV; only for participants unable to perform the 6 minute walk (6MW) test; worsening of WHO functional class by 1 or more for participants who can perform a 6 minute walk (6MW) test and who have a decrease of ≥ 20% in the 6 minute walk distance (for those participants who are ≥6 years of age).|Period 2 Baseline through Study Completion (Estimated up to 24 Months)||2022-04-30|04/2022||||
2633504|NCT01824290|Secondary|Period 2: Time to First Occurrence of CW|Clinical worsening was defined as any of the following: death, lung or heart transplantation, atrial septostomy or Potts' shunt, hospitalization for Pulmonary Arterial Hypertension (PAH) progression, new onset syncope, initiation of new PAH therapy (including increase in the dose of existing PAH specific concomitant therapy, such as endothelin receptor agonist or beraprost medication), or increase of 1 or more in World Health Organization(WHO) Functional Class (except for participants already in Class IV; only for participants unable to perform the 6 minute walk (6MW) test; worsening of WHO functional class by 1 or more for participants who can perform a 6 minute walk (6MW) test and who have a decrease of ≥ 20% in the 6 minute walk distance (for those participants who are ≥6 years of age).|Period 2 Baseline through Study Completion (Estimated up to 24 Months)||2022-04-30|04/2022||||
2633505|NCT01824290|Secondary|Period 1: Pharmacokinetics (PK): Apparent Clearance (CL/F) of Tadalafil at Steady-state|Period 1: Pharmacokinetics (PK): Apparent Clearance (CL/F) of Tadalafil at steady-state|Week 2, Week 4, Week 16 and Week 24|All participants who received at least one dose of study drug and had evaluable PK data.|||Liter Per Hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2633506|NCT01824290|Secondary|Period 1: Percentage of Participants Who Experience CW|Clinical worsening was defined as any of the following: death,lung or heart transplantation,atrial septostomy or Potts' shunt,hospitalization for Pulmonary Arterial Hypertension(PAH) progression,new onset syncope, initiation of new PAH therapy(including increase in the dose of existing PAH specific concomitant therapy,such as endothelin receptor agonist or beraprost medication),or increase of 1 or more in World Health Organization(WHO) Functional Class(except for participants already in Class IV; only for participants unable to perform the 6 minute walk(6MW) test;worsening of WHO functional class by 1 or more for participants who can perform a 6 minute walk(6MW) test and who have a decrease of ≥ 20% in the 6 minute walk distance(for those participants who are ≥6 years of age).Criteria for CW(from Period 1) were adjudicated by an independent,blinded study-specific Clinical Endpoint Committee(CEC).This adjudication was used for data analysis, and was not used to guide subject treatment.|Baseline through Week 24|All participants who received at least one dose of study drug.|||percentage of participants|||Number
2633507|NCT01824290|Secondary|Period 1: Time to Adjudicated Clinical Worsening (CW)|Clinical worsening was defined as any of the following: death,lung or heart transplantation,atrial septostomy or Potts' shunt,hospitalization for Pulmonary Arterial Hypertension(PAH) progression,new onset syncope,initiation of new PAH therapy(including increase in the dose of existing PAH specific concomitant therapy,such as endothelin receptor agonist or beraprost medication), or increase of 1 or more in World Health Organization(WHO) Functional Class(except for participants already in Class IV;only for participants unable to perform the 6 minute walk(6MW) test;worsening of WHO functional class by 1 or more for participants who can perform a 6 minute walk(6MW) test and who have a decrease of ≥ 20% in the 6 minute walk distance(for those participants who are ≥6 years of age). Criteria for CW(from Period 1) were adjudicated by an independent,blinded study-specific Clinical Endpoint Committee(CEC).This adjudication was used for data analysis, and was not used to guide subject treatment.|Baseline through Week 24|All participants who received at least one dose of study drug.|||Weeks||95% Confidence Interval|Median
2633508|NCT01824290|Primary|Period 1: Change From Baseline to Week 24 in a 6 Minute Walk (MW) Distance in Meters|6MWD in meters assessed in a subset of participants who are ≥6 to <18 years of age who are developmentally capable of performing a 6MW test. Change from baseline was derived using mixed model repeated measures (MMRM) with terms for treatment group, visit, baseline 6MWD, and treatment-by-visit interaction.|Baseline, Week 24|All participants who received at least one dose of study drug who were > = 6 to < 18 years of age and were capable of performing a 6MW test.|||Meters||Standard Error|Least Squares Mean
2633509|NCT01824160|Primary|Successful Repair of Conduit Disruption|"Successfully cover a tear or disruption in a RV-PA conduit wall and prevent the development of rupture or bleeding into the mediastinum during additional enlargement of the conduit. Provide persistent conduit wall integrity.~A severity of illness scale categorizes the degree of clinical illness at baseline to be compared to the remaining level of illness after placement of the Covered CP Stent (CCPS). We assess the number of participants with minimal level of illness (level 0 to 1) after CCPS placement.~0 = No injury or conduit wall disruption~= Contained disruption~= Partially contained disruption~= Uncontained conduit disruption"|Implant of Covered Stent and 6 month follow up||||participants|||Number
2633510|NCT01823991|Other Pre-specified|Change in Plasma Cytokines|Mean change plasma cytokines from baseline to post intervention with Cognutrin vs. placebo. Inflammatory markers-Cytokines were measured with a panel including IFN-g, IL-6, IL-8 and INF-alpha.|3 months|All evaluable participants at time of analysis|||pg/mL||Standard Error|Mean
2633511|NCT01823991|Secondary|Number of Participants With Improvement in Function MRI and Structural MRI Post-Intervention|Functional: Improved cortical activation in multiple areas of the brain on examination of functional MRI post study intervention. Imaging including: 1) Extended resting state functional MRI with data post-processed on Philips EWS. Performed with patient's eyes closed and minds wandering. 2) Diffusion tensor imaging (DTI) with effective slice thickness of 2.3mm. Post-processed on Philips EWS with color-coded DTI tractography images obtained, absolute FA calculations performed in 9 anatomic areas in both right and left brain with total of 18 FA values obtained per examination. Structural: Improved white matter signal changes which correlate with ischemic changes or microvascular ischemic changes, cortical atrophy, hippocampal atrophy, brain volume and gray-white matter ratio. Anatomic sequences including: 1) Coronal 3-D volume T1 weighted gradient echo images with effective slice thickness of 1mm. 2) Axial FLAIR (fluid attenuated inversion recovery)|3 months|All participants with both pre- and post-therapy brain MRI examinations.|||Participants|||Count of Participants
2633512|NCT01823991|Secondary|Number of Participants Experiencing Grade 3 or Higher Adverse Events|The primary safety endpoint is incidence and severity of AEs occurring during intervention with either COGNUTRIN or placebo. All AEs that are reported by the subject, detected during a visit, physical examination, or laboratory work-up will be recorded in the participant's medical record and recorded on the case report form (CRF). All AEs that occur after the informed consent is signed will be recorded on the AE CRF whether or not related to study agent, using the NCI Common Terminology Criteria for AEs (CTCAE) version 4.0.|3 months from baseline +/- 7 days|Evaluable participants who received treatment.|||participants|||Number
2633513|NCT01823991|Secondary|Occurrence of Adverse Events (AEs) by Causality|Number of Adverse events according to relation to study treatment category: Definitely related, Probably related, Possibly related, Unlikely to be related, Unrelated.|3 months from baseline +/- 7 days|Participants with Adverse Events.|||Adverse Events|||Number
2633514|NCT01823991|Secondary|Number of Participants With Adverse Events (AEs)|The primary safety endpoint is incidence and severity of AEs occurring during intervention with either COGNUTRIN or placebo. All AEs that are reported by the participant, detected during a visit, physical examination, or laboratory work-up will be recorded in the participant's medical record and recorded on the case report form (CRF). All AEs that occur after the informed consent is signed will be recorded on the AE CRF whether or not related to study agent, using the NCI Common Terminology Criteria for AEs (CTCAE) version 4.0.|3 months from baseline +/- 7 days|All evaluable participants who received treatment.|||Participants|||Count of Participants
2633515|NCT01823991|Primary|Change in Cognitive Function Scores With Intervention - Symbol Digit Modalities Test|Mean change in cognitive function scores measured from baseline to post intervention with Cognutrin compared to placebo arms of the trial. Mean cognitive function scores by group and compared by time of testing (Time 1, Time 2). The Symbol Digit Modalities Test requires respondents to write the number that corresponds with each symbol for a series of 110 items in which the symbol but not the number appears. Respondents identify the correct number using a key provided in which symbols are matched with numbers. Total score is determined by calculating the number of items correctly completed in 90 seconds Scale uses z-scores which have a mean of 0 and a standard deviation of 1. Scores cores above 0 indicate better than average performance whereas scores below 0 indicate poorer than average performance.|Baseline (Time 1) and at 3 months +/- 7 days (Time 2)|All evaluable participants at time of analysis.|||score||Standard Error|Mean
2633516|NCT01823991|Primary|Change in Cognitive Function Scores With Intervention - Digit Span|Mean change in cognitive function scores measured from baseline to post intervention with Cognutrin compared to placebo. Mean cognitive function scores by group and compared by time of testing (Time 1, Time 2). The Digit Span assesses immediate verbal memory and auditory attention. The examiner reads increasingly longer series of numbers and the respondent is required to repeat them in the same order. The examiner then reads additional sequences of numbers and the respondent is required to repeat them in reverse order. Digit Span yields one score, number of items completed correctly. Scores are scaled from the Wechsler Adult Intelligence Scale. The values for these scaled scores indicated that values from 1-7 indicate below average performance, corresponding to 1-16 percentile ranks. Scores between 8-12 indicate average performance, corresponding to percentile ranks of 25-75. Scores between 13-19 correspond to areas of strength and 84-99 percentile ranks.|Baseline (Time 1) and at 3 months +/- 7 days (Time 2)|All evaluable participants at time of analysis.|||score||Standard Error|Mean
2633517|NCT01823991|Primary|Change in Cognitive Function Scores With Intervention - Color Trails 1 & 2|Mean change in cognitive function scores measured from baseline to post intervention with Cognutrin compared to placebo arms of the trial. Mean cognitive function scores by group and compared by time of testing (Time 1, Time 2). Tests: Color Trails 1 & Color Trails 2. Color Trails 1 consists of a page with scattered circles numbered from 1-25. Even numbered circles are colored yellow and odd numbered ones are colored pink. Respondents are instructed to connect the circles in consecutive numeric order with a continuous line as quickly as possible. Score is determined by recording the number of seconds required to complete the task. Color Trails 2 consists of a page containing 25 pink circles and 25 yellow circles numbered 1-60. Respondents are instructed to connect circles in consecutive order while alternating colors. A total score is determined by recording the number of seconds required to compete the task.|Baseline (Time 1) and at 3 months +/- 7 days (Time 2)|All evaluable participants at time of analysis.|||seconds||Standard Error|Mean
2633518|NCT01823991|Primary|Change in Cognitive Function Scores With Intervention - HVLT and COWA|Mean change in cognitive function scores measured from baseline to post intervention with Cognutrin compared to placebo. Mean cognitive function scores by group and compared by time of testing (Time 1, Time 2). The HVLT test assesses verbal learning and memory. Subjects are given a list of words and asked to repeat as many words as they can recall at 3 times. There is no absolute low & high, as scores are age adjusted. Reported scores are T-scores- average score should be 50, with a standard deviation of 10. Any score below 50 indicates performance below population averages and any score above 50 indicates higher than population averages.The COWA test is a verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with a designed letter. The scores are converted to z-scores. A Z score of -1 is 1 standard deviation below mean. The lowest and highest Z scores could be ≤ -3.0 and ≥3.0. A lower Z score is indicative of poor fluency.|Baseline (Time 1) and at 3 months +/- 7 days (Time 2)|All evaluable participants at time of analysis.|||score||Standard Error|Mean
2633519|NCT01823861|Secondary|Contraceptive Discontinuation||4 months|||||||
2633520|NCT01823861|Secondary|Repeat Abortion||4 months|||||||
2633528|NCT01823653|Secondary|Global Aesthetic Improvement Scale (GAIS) Score Post Treatment Assessed by Investigator for Determining Clinical Improvement|"Mean Investigator improvement at 12 weeks using the GAIS Scale.~*GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved"|12 weeks|Per protocol|||units on a scale||Standard Deviation|Mean
2633529|NCT01823653|Secondary|Subcutaneous Adipose Thickness|Ultrasound assisted measurement of adipose tissue thickness|12 weeks|||||||
2633530|NCT01823653|Secondary|Safety Assessment|Discomfort level during treatment using the Visual Analog Scale (VAS) and post-treatment skin reponses or side effects using a 0-3 severity scale.|1, 4, 8, 12 weeks|||||||
2633531|NCT01823653|Secondary|Patient Satisfaction Using 1-5 Likert Scale|Likert scale ranges from 1=Very Dissatisfied to 4=satisfied, 5=very satisfied. Percentage of participants rated 4 and 5 are reported below|12 weeks|Per protocol|||percentage of subjects satisfied|||Number
2633532|NCT01823653|Secondary|Percentage of Participants Showing Clinical Improvement Using the Global Aesthetic Improvement Scale (GAIS) Post Treatment, Assessed by Investigator|"Investigator improvement at 12 weeks using the GAIS Scale, as presented based on percentage of subjects showing improvement. Outcome presented in % of participants that had GAIS scores of either 4 (improved) or 5 (much improved) at 12 weeks post treatment.~*GAIS Scale: 1=Much Worse, 2=Worse, 3=No Improvement, 4=Improved, 5=Much Improved"|12 weeks|Per protocol|||Percentage of subjects improved|||Number
2633533|NCT01823653|Primary|Clinical Improvement in Thigh Circumference|Clinical improvement measured by change from baseline thigh circumference after treatment|12 weeks (minus baseline)|Per Protocol|||centimeter||Standard Error|Least Squares Mean
2633534|NCT01823614|Other Pre-specified|Estimation of the R5- and X4-tropic HIV Variants Ratio Stratified by CD4 Cell Count Among Naive Patients||24 weeks||||participants|||Number
2633535|NCT01823614|Secondary|Estimation of the R5- and X4-tropic HIV Variants Ratio Stratified by CD4 Cell Count||24 weeks||||participants|||Number
2633536|NCT01823614|Primary|Determination of the Prevalence of R5 and X4-tropic Variants of HIV in HIV-infected Population in Russia||24 weeks||||participants|||Number
2633537|NCT01823536|Secondary|Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.|The safety and tolerability of one injection of MenACWY-CRM vaccine, administered in the present study, was evaluated in terms of the number of subjects reporting unsolicited adverse events, serious adverse events and adverse events leading to premature withdrawal.|Day 1 to day 28|The analysis was done on unsolicited safety set, ie, all exposed subjects who provided unsolicited adverse events (AE) data.|||Number of subjects|||Number
2633538|NCT01823536|Secondary|Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.|"The number of subjects reporting solicited local and systemic adverse events after one injection of MenACWY-CRM vaccine was administered in the present study to,~Subjects, who had 5 years earlier received either one or two doses of MenACWY-CRM vaccine~Vaccine-naive subjects."|Day 1 to day 7 post-vaccination|The analysis was done on solicited safety set, ie, all subjects in the exposed set who provided post vaccination solicited reactogenicity data.|||Number of subjects|||Number
2633539|NCT01823536|Secondary|Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.|The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of GMTs.|Day 28 post-vaccination|The analysis was done on per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2633540|NCT01823536|Secondary|Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.|The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of the percentages of subjects with hSBA titers ≥1:8.|Day 28 post-vaccination|The analysis was done on per-protocol population.|||Percentages of subjects||95% Confidence Interval|Number
2633541|NCT01823536|Secondary|Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects|The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine five years earlier in the parent study, are compared with the hSBA response in age matched vaccine-naive subjects.|5 years post-vaccination; baseline for naive|The analysis was done on per-protocol population.|||Percentages of subjects||95% Confidence Interval|Number
2633542|NCT01823536|Secondary|Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine.|The persistence of geometric mean titers (GMTs) against N.meningitidis serogroups A, C, W and Y in subjects who had received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported.|5 years post-vaccination|The analysis was done on per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2633543|NCT01823536|Primary|Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine|"The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported.~The serum bactericidal antibodies directed against N.meningitidis serogroups, are measured by human complement Serum Bactericidal Assay (hSBA)."|5 years post-vaccination|The analysis was done on per-protocol population i.e all subjects who provided immunogenicity data; had no major protocol deviations and who were not excluded due to other reasons defined prior to analysis.|||Percentages of subjects||95% Confidence Interval|Number
2633544|NCT01823510|Secondary|Platelet Reactivity Index (PRI)|Platelet reactivity index by Vasodilator-Stimulated Phosphoprotein phosphorylation (VASP) assay.|up to 7 days||||percentage of baseline PRI||Standard Error|Mean
2633545|NCT01823510|Secondary|P2Y12 Reaction Unit (PRU)|Platelet reactivity by measuring P2Y12 Reaction Unit using Accumetrics VerifyNow|up to 7 days||||percentage of baseline PRU||Standard Error|Mean
2633548|NCT01823341|Secondary|Percent of Mornings With Urine Ketones >/= 15 mg/dl|Urine ketones measured each morning with Ketostix.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."|||percentage of mornings|Participants||Number
2633549|NCT01823341|Secondary|Morning Blood Ketones >=1.0 mmol/L|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."|||percentage of mornings|Participants||Number
2633550|NCT01823341|Secondary|Percentage of Mornings With Blood Glucose >250 mg/dL (>13.9 mmol/L)|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."|||percentage of mornings|Participants||Number
2633551|NCT01823341|Secondary|Mean Morning Blood Glucose|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."|||mg/dL|Participants|Standard Deviation|Mean
2633552|NCT01823341|Secondary|Percentage of Overnight Time Spent With CGM Value >250 mg/dL (13.9 mmol/L), Normalized to an 8-hour Period.|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old age group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."|||percentage of time|Participants|Inter-Quartile Range|Median
2633553|NCT01823341|Secondary|Percentage of Time Overnight Sensor Glucose Values 71 to 180 mg/dL (3.9 to 10.0 mmol/L), Normalized to an 8-hour Period.|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."|||percentage of time|Participants|Standard Deviation|Mean
2633554|NCT01823341|Secondary|Mean Sensor Glucose Overnight|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old age group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."|||mg/dL|Participants|Standard Deviation|Mean
2633555|NCT01823341|Secondary|Percentage of Nights With 1 or More Sensor Glucose Values <50 mg/dL (<2.8 mmol/L)|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."|||percentage of nights|Participants||Number
2633556|NCT01823341|Secondary|Percentage of Nights With 1 or More Sensor Glucose Values <70 mg/dL (<3.9 mmol/L)|"Please note we considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use.|"One participant in the 4-10 year old group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal an thus our final analyses had a slightly higher number of nights than expected."|||percentage of nights|Participants||Number
2633569|NCT01823224|Secondary|Total Opioid Consumption From Time of First Waking to T24|"Pain diary will be filled out every 6 hours for 24 hours after discharge in which the following will be recorded:~Opioid consumption from first waking to T4~Total opioid consumption from T0 to T4~Total opioid consumption from time of first waking to T24"|every 6 hours for 24 hours||||milligrams||Standard Deviation|Mean
2635684|NCT01800968|Secondary|Change in Left Ventricular End-Diastolic Volume Index|Change in Left Ventricular End-Diastolic Volume Index from baseline to 180 days.|Baseline to 180 days|All randomized subjects.|||ml per meter squared||Standard Deviation|Mean
2633557|NCT01823341|Primary|Comparison of the Time Spent in Hypoglycemia (<70 mg/dl, 3.9 mmol/L) Overnight on Intervention Nights Versus Control Nights, Normalized to an 8-hour Period.|"Each night is categorized as to whether hypoglycemia occurred. Hypoglycemia is defined as the occurrence of one or more CGM glucose values ≤70 mg/dL (3.9 mmol/L). The time period for outcome assessment each night will be from the time the system is activated in the evening until the time it is deactivated in the morning. The percentage of hypoglycemic nights (CGM glucose value ≤70 mg/dL (3.9 mmol/L)) will be tabulated separately with versus without the closed-loop control system in use. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use.|"One participant in the 4-10 year old age group with 5 intervention nights and 5 control nights was excluded for <80h of CGM glucose data. We considered nights with at least 4 hours of sensor glucose data as a valid night toward the 42 night overall goal and thus our final analyses had a slightly higher number of nights than expected."|||percentage of time|Participants|Inter-Quartile Range|Median
2633558|NCT01823328|Secondary|Mortality|Mortality will be assessed at 30 days or at discharge from the hospital, whichever occurs first. This study is not powered to detect a significant difference in mortality, however; this will primarily be a safety study comparing the use ketamine versus etomidate as sedative agents for rapid sequence intubation (RSI) in the Emergency Department (ED).|30 Days or Discharge||||Participants|||Count of Participants
2633559|NCT01823328|Secondary|Peak and Plateau Pressure|The Peak and plateau pressures will be compared between the two groups, with a pre-defined subgroup analysis of patients who are being intubated for severe asthma and chronic obstructive pulmonary disease (COPD). The ventilator was used to measure these values.|up to 30 minutes (average time frame)|Those with peak and plateau pressure available|||cm water||Inter-Quartile Range|Median
2633560|NCT01823328|Secondary|Number of Patients With Hypotension|"The following will be compared between the two groups:~Hypotension in the ED post-intubation~Hypotension within the first 6 hours of the hospital stay, including time spent in the ED~Hypotension is defined as a systolic blood pressure less than 90 mm Hg"|up to 6 hours||||Participants|||Count of Participants
2633561|NCT01823328|Secondary|Number of Patients With Post-intubation Hypoxemia|"The following will be compared between the two groups:~Hypoxemia and severe hypoxemia in the peri-intubation period. Peri-intubation hypoxemia was defined as during after the 5 minutes immediately after intubation.~Hypoxemia within the first 2 hours intubation~Hypoxemia is defined as SpO2 less than 90%. Severe hypoxemia is defined as SpO2 less than 90% for 60 seconds or more."|up to 2 hours|Those with oxygen saturation data|||Participants|||Count of Participants
2633562|NCT01823328|Secondary|Doses of Post-intubation Sedation|The number of bolus doses of sedative administered post-intubation will be compared up to 6 hours (including morphine, dexmedetomidine, propofol , etomidate, ketamine, lorazepam (Ativan), midazolam (Versed), diazepam (Valium), fentanyl, hydromorphone (Dilaudid)). Infusions of these medications will be recorded separately but will not be part of this outcome.|up to 6 hours||||bolus doses of sedation||Inter-Quartile Range|Median
2633563|NCT01823328|Secondary|Number of Patients With First-pass Success|The rate of first pass success, defined as successful tracheal intubation on the first attempt. An attempt is defined as the insertion and subsequent removal of the laryngoscopic device from the patient's mouth, regardless of whether an endotracheal tube was inserted.|up to 5 minutes (average time frame)||||Participants|||Count of Participants
2633564|NCT01823328|Secondary|Mortality in Sepsis and Septic Shock|"Evaluate mortality for the sub-group diagnosed with sepsis and septic shock, defined as:~- Suspected infection, and at least 2 of 4 systemic inflammatory response syndrome (SIRS) criteria:~Temperature >38C or <36C~Respiratory Rate >20 or PaCO2 <32 mmHg~Heart Rate >90~White blood cell count >12,000 or <4,000, or > 10% bands~Septic shock:~defined as sepsis plus either: 1) Systolic blood pressure <90 after 1L of intravenous fluid or 2) lactate >=4mmol/L"|30 Days|Subgroup of those with sepsis|||Participants|||Count of Participants
2633565|NCT01823328|Primary|SOFA Score|*Maximum SOFA score within three hospital days: all patients. SOFA score is the Sequential Organ Failure Assessment. The minimum score is 0, the maximum score is 24, with higher scores indicating higher likelihood of worse outcome.|up to 3 days||||units on a scale||Inter-Quartile Range|Median
2633566|NCT01823289|Primary|Number of Participants With Comprehensive Efficacy|Comprehensive efficacy was assessed as cured: the symptoms, signs, laboratory examination and pathogenic examination were return to normal; markedly improved: the disease condition was markedly improved but symptoms, signs, laboratory examination and pathogenic examination were not return to normal; improved: the disease condition was improved to some extent after drug administration, but the improvement was not significant enough; failed: the disease condition was not improved significantly or worsened after drug administration.|Week 6|The Full analysis set (FAS) population included all participants who received at least 1 intravenous infusion or oral solution of the study drug and completed at least 1 post-baseline visit.|||participants|||Number
2633567|NCT01823289|Primary|Number of Participants With Mycological Efficacy|Mycological efficacy was assessed as fungi cleared: negative for fungal microscopic examination and culture (test for infection or organisms that could cause infection); fungi not cleared: positive for fungal microscopic examinations and/or culture.|Week 6|The Full analysis set (FAS) population included all participants who received at least 1 intravenous infusion or oral solution of the study drug and completed at least 1 post-baseline visit. Here 'N' signifies those participants who were evaluable for this measure.|||participants|||Number
2633568|NCT01823289|Primary|Number of Participants With Clinical Efficacy|Clinical efficacy was assessed as cured: the signs and symptoms of invasive fungal infections (IFI) completely disappeared or full or nearby resolution of radiographic manifestations; markedly improved: the signs and symptoms of IFI were improved or disappeared and at least 50 percent improvement of radiographic findings; improved: the signs and symptoms of IFI were moderately improved and less than 50 percent improvement of radiographic findings; failed: the clinical symptoms and signs of IFI were not changed or worsened.|Week 6|The Full analysis set (FAS) population included all participants who received at least 1 intravenous infusion or oral solution of the study drug and completed at least 1 post-baseline visit.|||participants|||Number
2635699|NCT01800201|Secondary|Total Vascular Inpatient Readmissions|This is the number of vascular inpatient admission events control vs. intervention|Date of enrollment + 12 months||||readmissions|||Number
2633570|NCT01823224|Primary|Pain|Pain after treatment with IV versus oral tylenol will be assessed via pain scores utilizing an numerical rating scale (NRS) )0-10 with 0 as no pain and 10 as worst pain with 5 as moderate pain and faces accompanied the scores with full smile on no pain to tears and frown on worst pain.|24 hours after discharge||||NRS scale||Standard Deviation|Mean
2633571|NCT01823146|Secondary|Functional Connectivity (Resting fMRI)|The functional connectivity (strength measure in units on a scale) between amygdala and medial prefrontal cortex was measured via a resting functional magnetic resonance imaging scan (participants looked at a fixation cross while images of their brain at rest were taken). Functional connectivity is the connectivity between brain regions (i.e., amygdala and medial prefrontal cortex) that share functional properties. It is defined as the temporal correlation between spatially remote neurophysiological events, expressed as deviation from statistical independence across these events in distributed neuronal groups and areas. A mean of this correlation (connectivity strength) was computed and transformed into z-scores (r to z transformation). The z-scores ranged from -2 to +2 with higher scores representing a greater resting-state functional connectivity.|1.5 hours after oxytocin/placebo administration|All study participants who had undergone the screening as well as the full visit and had reliable resting fMRI scan data (e.g., low extent of head motion) (n = 79).|||z-scores||95% Confidence Interval|Least Squares Mean
2633572|NCT01823146|Secondary|Meta-Mood|Mean self-reported level of meta-mood for the two subscales attention to feelings and clarity of feelings. Response scale ranged from 1 to 5, with higher scores indicating more attention to feelings and greater clarity of feelings, respectively. The mean score for the subscales were calculated.|2.5 hours after drug/placebo administration|All study participants who had undergone the screening as well as the full visit (n = 102).|||units on a scale||Standard Error|Mean
2633573|NCT01823146|Primary|Extent of Trust Behavior|"Average amount of monetary units invested in the context of the Trust/Lottery Game.~The theoretical range was 0 to 72 monetary units across all 24 trials. Participants invested in 12 social (human person) and 12 non-social (computer) trials.The mean average amount of monetary units invested was calculated for social and non-social trials separately."|45 minutes after drug/placebo administration|All study participants who had undergone the screening as well as the full visit (n = 102).|||monetary units||Standard Error|Mean
2633574|NCT01823107|Secondary|Rate of Reconstruction Failure|Reconstruction failure was defined as a serious adverse event in a reconstructed breast resulting in unplanned removal of the prosthesis and/or Meso BioMatrix Acellular Peritoneum Matrix.|18 months|Forty-four (44) breasts were reconstructed among the 25 enrolled subjects. Reconstruction failure was evaluated on a per reconstructed breast basis.|||Reconstructed breasts affected|Reconstructed breasts||Number
2633575|NCT01823107|Secondary|Measurement of Aesthetic Satisfaction With the Use of the Breast-Q Survey|Subjects completed the reconstructive module of the BREAST-Q, a standardized instrument measuring patient satisfaction and health-related quality of life on a scale of 1 to 100, with higher scores indicating higher satisfaction. Completed Breast-Q questionnaires were scored according to the author's instructions. Aesthetic satisfaction was measured using the Breast-Q Satisfaction with Breasts subscale score.|18 months (12 months after second stage reconstruction)||||score on a scale||Standard Deviation|Mean
2633576|NCT01823107|Primary|Rate of Breast Related Adverse Events|Investigators evaluated each subject and each reconstructed breast for the occurrence of an adverse event from the first stage of reconstruction through the final follow-up visit. A breast related adverse event was defined as any untoward medical occurrence related to a reconstructed breast.|18 months||||Reconstructed breasts affected|Reconstructed breasts||Number
2633577|NCT01822925|Secondary|Average Weekly Rescue Medication Use|During the Treatment Periods, subjects taking 500 mg acetaminophen or Tylenol® for severe pain recorded the frequency and dosage in the daily diary. The use of 500 mg acetaminophen or Tylenol® was recorded for Morning, Afternoon or Evening time. For each subject, the total weekly rescue medication was calculated, and it was used to assess average weekly rescue medication use.|Week 1 to Week 12|Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.|||mg||Standard Deviation|Mean
2633578|NCT01822925|Secondary|Number of Participants Number of Participants Considered to be Responders in Clinical Global Impression (CGI) at Week 12|"CGI measures global severity of illness at a given point of time and the improvement from baseline. The assessment was to be completed by the Investigator at baseline and each week during the treatment phase.~CGI responders were defined as subjects achieving a score of: (1): Very much improved or (2): Much improved or (3): Minimally improved on the clinician-rated CGI global improvement item."|Week 12|Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.|||Participants|||Count of Participants
2633579|NCT01822925|Secondary|Number of Participants Considered to be Responders on Global Impression of Improvement (PGI-I) at Week 12|"PGI measures the subject's overall improvement in pain. The assessment was to be completed each week during the Treatment Phase.~Global impression of improvement was assessed by the subject based on a 7 point scale (1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, 7-very much worse.~Responders are defined as subjects with response of very much improved, much improved or minimally improved"|Week 12|Intent-to-Treat (ITT) population – defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.|||Participants|||Count of Participants
2633580|NCT01822925|Secondary|Change From Baseline Within Group-Difference in Average Weekly Overnight Pain Score Compared to Baseline as Assessed by Daily Diary|"Overnight pain intensity was assessed daily based on the 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Average weekly overnight pain scores are defined as 7* [(Pain Day 1 + Pain Day 2 + …+ Pain Day n)]/n where n is the number of available diary entries for the week. The minimum possible pain score for a week would be 0 and the maximum possible would be 70.~Difference in the average weekly overnight pain score at Week 12 is the score at each week minus baseline"|Baseline to 12 week treatment period|Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.|||average weekly overnight pain score||Standard Deviation|Mean
2657237|NCT01607450|Secondary|Myocardial Blood Flow|Myocardial perfusion derived from acetate kinetics|After 12 hours of GLP-1 exposure||||ml/min/100g||Standard Deviation|Mean
2633581|NCT01822925|Secondary|Change From Baseline Within Group- Difference in Average Weekly Pain Score Compared to Baseline as Assessed by Daily Diary|"Average weekly pain intensity was assessed daily based on the 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Average weekly pain scores are defined as 7* [(Pain Day 1 + Pain Day 2 + …+ Pain Day n)]/n where n is the number of available diary entries for the week. The minimum possible pain score for a week would be 0 and the maximum possible would be 70.~Difference in the average weekly pain score at Week 12 is the score at each week minus baseline."|Baseline to 12 week treatment period|Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.|||average weekly pain score||Standard Deviation|Mean
2633582|NCT01822925|Secondary|Difference in Average Weekly Overnight Pain Score Between Dose Groups as Assessed by Daily Diary|"Overnight pain intensity was assessed daily based on the 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Average weekly overnight pain scores are defined as 7* [(Pain Day 1 + Pain Day 2 + …+ Pain Day n)]/n where n is the number of available diary entries for the week. The minimum possible pain score for a week would be 0 and the maximum possible would be 70.~Difference in the average weekly overnight pain score at Week 12 is the score at each week minus baseline"|Baseline to 12 week treatment period|Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.|||average weekly overnight pain score||Standard Deviation|Mean
2633583|NCT01822925|Secondary|Difference in Average Weekly Most Severe Pain Score Between Dose Groups as Assessed by Daily Diary|"Most severe 24-hour pain intensity was assessed daily based on the 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Average weekly most severe pain scores are defined as 7* [(Pain Day 1 + Pain Day 2 + …+ Pain Day n)]/n where n is the number of available diary entries for the week. The minimum possible pain score for a week would be 0 and the maximum possible would be 70.~Difference in the average weekly pain score at Week 12 is the score at each week minus baseline ."|Baseline to 12 week treatment period|Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.|||weekly most severe pain score||Standard Deviation|Mean
2633584|NCT01822925|Secondary|Difference in Average Weekly Pain Score Between Dose Groups as Assessed by Daily Diary|"Average 24-hour pain intensity was assessed daily based on the 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain). Average weekly pain scores are defined as 7* [(Pain Day 1 + Pain Day 2 + …+ Pain Day n)]/n where n is the number of available diary entries for the week. The minimum pain score for a week would be 0 and the maximum would be 70.~Difference in the average weekly pain score at Week 12 is the score for each week minus the baseline ."|Baseline to 12 week treatment period|Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.|||Average weekly group pain score||Standard Deviation|Mean
2633585|NCT01822925|Secondary|Number of Participants With at Least 30% Improvement Compared to Baseline as Assessed by the 11- Point Likert Numerical Rating Scale (NRS) at the Week 12 Clinic Visit|"Pain intensity was assessed by the subject before any other protocol procedures at baseline and week 12 based on 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain).~The number of participants who had achieved ≥ a 30% reduction in pain from the baseline was to be compared between the treatment groups and placebo."|Baseline to 12 week treatment period|Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.|||Participants|||Count of Participants
2633586|NCT01822925|Secondary|Percentage Change in Clinic Visit Pain Score at the 12-week Visit Compared to Baseline as Assessed by the 11-point Likert Numerical Rating Scale (NRS)|Pain intensity was assessed by the subject before any other protocol procedures at baseline and at the 12- week visit using an 11-point Likert-type numerical rating scale for pain (0=no pain, to 10=worst possible pain) (Negative values indicate percentage reductions).|Baseline and over 12 week treatment period|Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.|||Percentage change||Standard Deviation|Mean
2633587|NCT01822925|Primary|Change in Clinic Visit Pain Score at the 12 Week Visit Compared to Baseline as Assessed by the 11-point Likert Numerical Rating Scale (NRS)|Pain score was assessed by the subject using the 11-point Likert rating scale for pain (0=no pain to 10=worst possible pain) prior to conduct of any other study assessment. The change in clinic visit pain score at the 12-week visit was compared to baseline.|Baseline to 12 weeks of treatment|Intent-to-Treat (ITT) population - defined as all subjects who were randomized and had an ICF. The ITT population was the primary population for the analysis of primary and secondary endpoints.|||Scores on a scale||Standard Deviation|Mean
2633588|NCT01822899|Secondary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. BL is defined as the mean of the assessments made 30 and 5 minutes (min) pre-dose on Treatment Day 1. Trough FEV1 on Day 85 is defined as the mean of the FEV1values obtained 23 and 24 hours after the previous morning's dosing (i.e., trough FEV1 on Day 85 is the mean of the FEV1 values obtained 23 and 24 hours after morning dosing on Day 84). Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, day, and day by BL and day by treatment interactions. The model used all available trough FEV1 values recorded on Days 28, 56, 84, and 85. Missing data were not directly imputed in this analysis; however, all non-missing data for a participant were used within the analysis to estimate the treatment effect for trough FEV1 at Day 85.|Baseline and Day 85|ITT Population. Participants analyzed were those with data available at the presented time point; but, all participants without missing covariate information were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2633636|NCT01822548|Secondary|Absolute Change in HbA1C Compared to Baseline|The secondary endpoint was the change from baseline values of HbA1C in the Vildagliptin vs Glibenclamide arm at 4 and 12 months|V0 (randomization), V2 (month4), V4 (month 12).||||percentage||Inter-Quartile Range|Median
2633589|NCT01822899|Primary|Change From Baseline (BL) in 0 to 24 Hour Weighted Mean Serial Forced Expiratory Volume in One Second (FEV1) at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), and smoking status.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received at least one dose of randomized study drug in the Treatment Period. Par. analyzed were those with data available at the presented time point but all par. without missing covariate information and with >= post BL measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2633590|NCT01822886|Secondary|Overall Response Rate (ORR)|"ORR the proportion of patients who achieve CR (complete response), CRu (complete remission unconfirmed) or PR (partial response) relative to the per-protocol population. Disease response and progression will be evaluated according to the Revised Response Criteria for malignant lymphoma (Cheson et al. 2007)."|24 months||||Participants|||Count of Participants
2633591|NCT01822886|Secondary|Safety - Frequency of Toxicities Grade 3 and 4|Frequency of toxicities was reported by type and grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).|24 months||||events|||Number
2633592|NCT01822886|Secondary|Overall Survival is Measured From the Date of Study Entry to the Date of Patient's Death|OS (overall survival) is measured from the date of study entry to the date of patient's death. If the patient is alive or his vital status is unknown, the date of death will be censored at the date that the patient is last known to be alive.|24 months||||percentage of partecipants||95% Confidence Interval|Number
2633593|NCT01822886|Secondary|Percentage of Participants With Progression-Free Survival|The time from start of study treatment to first documentation of objective tumor progression or to death due to any cause, whichever comes first. PFS (progression-free survival) data will be censored on the day following the date of the last radiological assessment of measured lesions documenting absence of progressive disease for patients who do not have objective tumor progression and are still on study at the time of an analysis, are given antitumor treatment other than the study treatment or stem cell transplant, or are removed from study prior to documentation of objective tumor progression. Patients lacking an evaluation of tumor response after their first dose will have their event time censored at 1 day. Percentage of participants is an estimate based on Kaplan-Meier method.|24 months||||percentage of partecipants||95% Confidence Interval|Number
2633594|NCT01822886|Primary|Complete Remission (CR) Rate|"Complete Remission is disappearance of all target lesions per the Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007)"|18 months||||Participants|||Count of Participants
2633595|NCT01822821|Secondary|Total Bilirubin (mg/dL)||Measured at 1 day and 2 days after surgery||||mg/dL||Inter-Quartile Range|Median
2633596|NCT01822821|Secondary|Aspartate Aminotransferase (AST); U/L||Two days after surgery or date of death from any cause, whichever came first||||U/L||Inter-Quartile Range|Median
2633597|NCT01822821|Secondary|Alanine Aminotransferase (ALT); U/L||Two days after surgery or date of death from any cause, whichever came first||||U/L||Inter-Quartile Range|Median
2633598|NCT01822821|Secondary|Hospital Length of Stay|Evaluate whether IV acetaminophen hospital length of stay|end of surgery through hospital discharge||||days||Inter-Quartile Range|Median
2633599|NCT01822821|Secondary|Intensive Care Unit (ICU) Length of Stay|Evaluate whether IV acetaminophen reduced intensive care unit (ICU) Length of Stay.|End of surgery through discharge from ICU||||hours||Inter-Quartile Range|Median
2633600|NCT01822821|Secondary|Duration of Mechanical Ventilation (Minutes)|Evaluate whether IV acetaminophen reduced duration of Mechanical Ventilation.|End of surgery until the initial end of ventilation or date of death from any cause, whichever came first, assessed up to 1 week.||||minutes||Inter-Quartile Range|Median
2633601|NCT01822821|Secondary|Postoperative Sedation|Postoperative sedation was assessed using the Richmond Agitation Sedation Scale (RASS). It ranges from -5 to +4, where -5 indicates no response to voice or physical stimulation and +4 indicates overtly combative or violent and immediate danger to staff. Lower the value, better the sedation.|Measured at 8, 16, and 24 hours after surgery|RASS scores were not collected at certain time points if patients were not available (e.g., patient was away at a test) or if staff were not available.|||units on a scale||Inter-Quartile Range|Median
2633602|NCT01822821|Secondary|Postoperative Nausea and Vomiting|Incidence of any postoperative nausea and vomiting within 24 hours after surgery was collected.|End of surgery through 24 hours after surgery||||Participants|||Count of Participants
2633603|NCT01822821|Primary|Pain Intensity|Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing pain intensity scores after cardiac surgery. Pain scores were measured on the Numeric Rating scale, ranging from 0 to 10 (where 0 indicates no pain and 10 indicates the worst pain imaginable).|End of surgery through 24 hours after surgery|All patients had at least one postoperative pain scores. Some patients did not have a pain score at particular time points if they were unavailable (e.g., at a test), unable to speak (e.g., intubated), asleep, or similar reasons. We report any available pain scores at each time they were collected.|||units on a scale||Standard Deviation|Mean
2633604|NCT01822821|Primary|Cumulative Opioid Consumption|Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption a after cardiac surgery. Total opioid consumption is defined as the total amount amount of opioids administered to patients converted to mg morphine equivalents.|End of surgery through 24 hours after surgery||||mg morphine equivalents||Inter-Quartile Range|Median
2633605|NCT01822756|Secondary|Duration of Response|Duration of response was the time from the first overall response contributing to an objective response to the first overall response of progressive disease (PD) occurring after the first overall response contributing to the objective response. Confidence intervals for median duration of response were calculated using the method of Brookmeyer and Crowley (1982).|Randomization to clinical cutoff 22Sept2015 (approx 244 days)|Intent-to-Treat Population (ITT) population - All subjects who received at least 1 dose of RUX|||days||Full Range|Median
2635700|NCT01800201|Secondary|1 Year Survival Probability Rate All Cause Readmissions|1 year survival probability rate for all cause readmissions|Date of enrollment + 12 months||||proportion of participants|||Number
2633606|NCT01822756|Secondary|Percentage of Responders|Duration of response was measured as the time from the first overall response contributing to an objective response to the first overall response of progressive disease (PD) occurring after the first overall response contributing to the objective response.|Randomization to clinical cutoff 22Sept2015 (approx 244 days)|Intent-to-Treat Population (ITT) population - All subjects who received at least 1 dose of RUX|||Percentage of responders|||Number
2633607|NCT01822756|Secondary|Percentage of Participants With a Best Response by RECIST Criteria|"Best response was determined on the subject level using the highest overall response achieved post-baseline. In the case of stable disease (SD), measurements had to meet the SD criterion at least once after study entry at a minimum interval of 49 days. Subjects who failed to meet this criterion had best response of progressive disease (PD) if the next available RECIST evaluation after the initial scan indicated PD or not evaluable (NE) if no additional RECIST evaluations were available.~Complete Response (CR) and Partial Response (PR) defined by the Response Evaluation Criteria in Solid Tumor (RECIST) criteria. CR: Disappearance of all target and nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter, or persistence of 1 or more nontarget lesion(s) or/and maintenance of tumor marker level above the normal limits."|every 2 cycles starting at Cycle 3 Day 1 up to approximately 4 to 6 months|Intent-to-Treat (ITT) Population - All subjects who received at least 1 dose of RUX|||percentage of participants|||Number
2633608|NCT01822756|Secondary|Clinical Activity as Measured by the Greatest Decrease in Tumor Burden Compared to Baseline.||Approximately 6 months|Enrollment of additional study cohorts was stopped after Cohort B1, RUX 10 mg BID-GCSF; Part 2 of the study was not conducted. Because of the early study termination, samples for pharmacokinetics and pharmacodynamics, and computed tomography for tumor burden were collected, but not analyzed; analysis data are not available.||||||
2633609|NCT01822756|Secondary|Plasma Concentration of Tumor Specific Biomarkers and Cytokines Before and During Treatment.||Up to 6 months|Enrollment of additional study cohorts was stopped after Cohort B1, RUX 10 mg BID-GCSF; Part 2 of the study was not conducted.Because of the early study termination, samples for pharmacokinetics and pharmacodynamics, and computed tomography for tumor burden were collected, but not analyzed; analysis data are not available.||||||
2633610|NCT01822756|Secondary|Plasma Concentrations Will be Used to Estimate Peak Plasma Concentration (Cmax) and Area Under the Plasma Concentration Curve (AUC).||Day 1 and Day 8|Further enrollment of additional study cohorts was stopped after Cohort B1, RUX 10 mg BID – GCSF; Part 2 of the study was not conducted. Because of the early study termination, samples for pharmacokinetics and pharmacodynamics, and computed tomography for tumor burden were collected, but not analyzed; analysis data are not available.||||||
2633611|NCT01822756|Primary|Percentage of Participants With Adverse Events That Are Defined as Dose Limiting Toxicities (DLTs)|Toxicities occurring during the first treatment cycle (Cycle 1) defined tolerability. Within each cohort, subjects were considered evaluable if they had received at least 40 of 56 planned doses of RUX during the 28-day surveillance period and received 2 of the 3 planned doses of chemotherapy (gemcitabine and/or gemcitabine and nab-paclitaxel) at the assigned dose level, or they had experienced a DLT.|Approximately 28 days|Safety population included all enrolled subjects who received at least 1 dose of RUX.|||percentage of participants|||Number
2633612|NCT01822691|Secondary|Number of Participants With Study Treatment Related Adverse Events (AEs)|Participants with treatment emergent Other (not including serious) Adverse events.|Up to 12 months|All participants|||participants|||Number
2633613|NCT01822691|Secondary|Number of Participants With Study Related Serious Adverse Events (SAEs)|Participants with treatment emergent Grade 3 or 4 SAEs according to the NCI Common Terminology Criteria for Adverse Events Version (CTCAE) V4.0.|Up to 12 months|All participants|||participants|||Number
2633614|NCT01822691|Secondary|Median Overall Survival (OS)|Overall Survival (OS) defined as the time between the start of treatment and death. Treatment Duration is 17 weeks plus optional continuation phase. Study Duration is Treatment Phase followed by survival follow-up.|Up to 24 months|All participants|||months||Full Range|Median
2633615|NCT01822691|Secondary|Mean Time to Acute Myeloid Leukemia (AML) Progression|Disease progression defined as progression to int-2 or high risk International Prognostic Scoring System (IPSS) score or AML, based on World Health Organization (WHO) AML Criteria.|Up to 12 months|All participants|||months||Full Range|Mean
2633616|NCT01822691|Primary|Overall Response Rate (ORR)|ORR, measured by Response Criteria for Patients with Myelodysplastic Syndrome (MDS). According International Working Group (IWG) 2006 criteria (Cheson et al, 2006). Complete Remission (CR), Partial Remission (PR), Marrow CR, and Hematological Improvement (HI)(any cell line). Stable Disease (SD): Failure to achieve at least PR, but no evidence of progression for > 8 weeks.|Up to 12 months|All participants|||participants|||Number
2633617|NCT01822678|Primary|Change in the Young Mania Rating Scale (YMRS) Total Score at the End of the 3-week Treatment Period, in Relation to the Baseline.|The YMRS is used to assess disease severity in patients who have been previously diagnosed with mania and it has proven psychometric properties through 11 item multiple-choice diagnostic questionnaire and the total score is determined from the summation of each 11 individual scores (and can range from 0 - 60) based on the patient's subjective feedback of his clinical condition over the previous 48 hours. A higher score indicates a worse rating for symptoms related to mania. At every visit throughout the study, investigators administered the YMRS. The results of the primary analysis of efficacy were calculated using Analysis of covariance (ANCOVA) with Last Observation Carried Forward (LOCF). Primary variable is presented through ANCOVA results for absolute change in YMRS total score from baseline (V2) to end of treatment (V7). A responder has at least 50% improvement (reduction) in the YMRS total score or has a total score of less than 12 points at the end of treatment period.|baseline and 3-week|The ITT efficacy population consisted of all randomised patients who received at least one dose of investigational product and at least 1 post-baseline YMRS assessment. If a patient discontinues before the end of the 3-week treatment period then the last observation will be carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2633618|NCT01822665|Secondary|Incidence of Fecal Occult Blood|The incidence of fecal occult blood was recorded as a binary response (0 = no presence of blood; 1 = presence of blood).|Day 7|ITT population: All participants who fulfilled all the study entry criteria and received at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.|||Participants|||Number
2633619|NCT01822665|Secondary|Incidence of Gastric and/or Duodenal Mucosal Injury|Number of participants with endoscopy score equal to or more than 2 were determined based on Lanza score for both gastric and duodenal mucosal damage.|Day 7|ITT population: All participants who fulfilled all the study entry criteria and receive at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.|||Participants|||Number
2633620|NCT01822665|Secondary|Duodenal Mucosal Damage (DMD) Scores|DMD was measured using a 5- point Lanza scale: 0 - normal duodenum; 1 - mucosal hemorrhages; 2 - one or two erosions; 3 - numerous areas of erosions and 4 - more than 10 erosions/ ulcers.|Day 7|ITT population: All participants who fulfilled all the study entry criteria and receive at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.|||Score on a scale||Standard Deviation|Mean
2633621|NCT01822665|Secondary|GMD Scores of Paracetamol Tablet; Ibuprofen Capsule; Ibuprofen Tablet; and Placebo Tablet|Endoscopic examination of the upper gastrointestinal mucosa evaluated the extent of mucosal injury to the stomach and the duodenum separately using a 5-point Lanza scale, ranging from 0: normal stomach; 1: mucosal hemorrhages; 2: one or two erosions; 3: numerous areas of erosions; and 4: more than 10 erosions or ulcer.|Day 7|ITT population: All participants who fulfilled all the study entry criteria and received at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.|||Score on a scale||Standard Deviation|Mean
2633622|NCT01822665|Primary|Gastromucosal Damage (GMD) Score of Paracetamol Tablet vs Ibuprofen Capsule|Endoscopic examination of the upper gastrointestinal mucosa evaluated the extent of mucosal injury to the stomach and the duodenum separately using a 5-point Lanza scale, ranging from 0: normal stomach; 1: mucosal hemorrhages; 2: one or two erosions; 3: numerous areas of erosions; and 4: more than 10 erosions or ulcer.|Day 7|Intent to Treat (ITT) population: all participants who fulfilled all the study entry criteria and receive at least one of the study treatments. The ITT population included all participants with valid data-period. Missing data was not imputed.|||Scores on a scale||Standard Deviation|Mean
2633623|NCT01822587|Primary|Use Days|Mean Days of Cocaine Use|Week 1, Week 3, Week 6||||Days||Standard Error|Mean
2633624|NCT01822587|Primary|Average Peak Craving Score|Peak Craving Response from Session Baseline- peak craving is measured by a scale with a score of 0 (no craving) -100 (maximum craving).|Day 2, Week 1, Week 3, and Week 6||||score on a scale||Standard Error|Mean
2633625|NCT01822587|Primary|Days of Abstinence|How many days the participants used cocaine versus how many days of abstinence they were able to achieve.|Week 1, Week 3, and Week 6||||Days|||Number
2633626|NCT01822587|Primary|Change in Craving Score|"The participant is asked, What is the level of craving you are experiencing on a scale or 0 to 100, with 0 representing no craving and 100 extreme craving?"|Single-Item Craving Scores are collected at all Retrieval Extinction Sessions (medication days), as well as all Phase Two Test Sessions (weeks 1,3 and 6).||||score on a scale||Standard Error|Mean
2633627|NCT01822587|Primary|Cocaine Use|Timeline of cocaine use throughout the duration of the study (in dollar amounts)|Evaluated at Weeks 1, 3 and 6||||Dollar amounts of cocaine use||Standard Error|Mean
2633628|NCT01822574|Secondary|Time to Complete Patella Resurfacing|Each patellar resection procedure began by exposing the articular surface of the patella. Once the patella was fully exposed and the surgeon measured the native patellar thickness, the timer was started. After the final resection, the timer was stopped.|Time 0 (prior to patella resection), and after surgery (approximately 3 hours)||||seconds||Standard Deviation|Mean
2633629|NCT01822574|Secondary|The Difference Between Surgeon Goal and Actual Resection Height|This outcome measure attempts to capture the most accurate method for obtaining a desired thickness. Each patellar resection procedure began by exposing the articular surface of the patella. Once the patella was fully exposed and the surgeon measured the native patellar thickness, the timer was started. The surgeon then stated their goal for post resection thickness, and these values were recorded. After the final resection, the timer was stopped. The ability to obtain the resection goal was independently assessed by a resident or fellow not involved in the resection. This was calculated by taking the difference between the surgeon's goal and the average thickness of the four quadrants measured by the resident or fellow.|Time 0 (prior to patella resection), and after surgery (approximately 3 hours)||||mm||Standard Deviation|Mean
2633630|NCT01822574|Primary|Mean Asymmetry of the Patella After Patella Resection|"Post-resection symmetry of the patella was independently assessed by a resident or fellow who was not involved in the resection. This was evaluated by dividing the patella into four equal quadrants and measuring the thickness in the center of each quadrant using a ring tipped or C-shaped caliper. The difference between the thickest and thinnest measurements of the patella was reported as the value of asymmetry."|approximate average surgery time of 3 hours||||mm||Standard Deviation|Mean
2633631|NCT01822561|Secondary|Change in Serum Potassium|Eplerenone can cause elevation of serum potassium. After initial screening, serum potassium was evaluated at 1 and 4 weeks after baseline.|Baseline and 1 month after treatment||||mEq/L||Standard Deviation|Mean
2633632|NCT01822561|Secondary|Change in Subfoveal Choroidal Thickness, Study Eye|Choroidal thickness can be measured using optical coherence tomography, and is known to be affected in patients with central serous chorioretinopathy. Thickness of the choroid under the fovea will be manually calculated in both the study eye.|Baseline and 1 month after treatment||||microns||Standard Deviation|Mean
2633633|NCT01822561|Secondary|Change in Best Corrected Visual Acuity|Visual acuity will be measured with standard eye charts, with manifest refraction at the initiation and conclusion of treatment. Although an important measure, this was not chosen as the primary outcome measure, as some patients with central serous chorioretinopathy may have a normal visual acuity when properly refracted (refraction can change with elevation of the macula by sub-retinal fluid)|Baseline and 1 month after treatment||||logMAR||Standard Deviation|Mean
2633634|NCT01822561|Secondary|Change in Macular Thickness|Automated software to calculate the thickness of the macula is standard on commercial OCT devices. Macular thickness before and after treatment will be assessed and compared.|Baseline and 1 month after treatment||||Microns||Standard Deviation|Mean
2633635|NCT01822561|Primary|Complete Resolution of Subretinal Fluid|Optical coherence tomography is an imaging technique capable of extremely high resolution (~5-7 microns) imaging of the macula, and is able to detect the presence and amount of subretinal fluid present, the key anatomic abnormality in Central Serous Chorioretinopathy|Baseline and 1 month after treatment||||participants|||Number
2633638|NCT01822535|Primary|Visit 2: Percent Change in Core Body Temperature With Midodrine|We will test the effects of midodrine on the ability to maintain a constant body temperature (e.g., core temperature of 98.6°F) after exposure to cool temperatures (64°F) in persons with tetraplegia through comparing the percent changes in core body temperature during visit 1 to percent changes in core body temperature during visit 2.|Baseline, Baseline Post-midodrine, Up to 2 hours|Subjects analyzed were individuals who completed visit 1 of testing.|||Percent Change||Standard Deviation|Mean
2633639|NCT01822535|Secondary|Visit 1: Percent Changes in Cognitive Performance - Delayed Recall|Cognitive performance will be evaluated using the Delayed Recall obtained using the Memory section of the Montreal Cognitive Assessment (MoCA). We will measure the change in cognitive performance in persons with tetraplegia after exposure to a cool environment (64°F) of up to 120 min in the seated position. Note: Scores are based on individual performance. All subjects are asked to remember two lists of five words (one list during baseline, and one list during cool Challenge). Lower scores indicate poorer performance, and a positive percent change in indicates improved cognitive performance.|Baseline, Up to 2 hours|Only the subjects with tetraplegia who demonstrated sympathetic interruption (insignificant decreases in distal skin temperatures, distal microvascular blood flow (LDF) and decreases of 1.0°C or greater in Tcore during cool exposure), and their matched able-bodied controls were analyzed.|||Percent Change||Standard Deviation|Mean
2633640|NCT01822535|Secondary|Visit 1: Percent Changes in Cognitive Performance - Stroop Interference|Cognitive performance will be evaluated using the Interference T-Scores obtained using the Stroop Color and Word Test. We will measure the change in cognitive performance in persons with tetraplegia after exposure to a cool environment (64°F) of up to 120 min in the seated position. Note: Interference T-Scores are derived from the difference between the raw Color-Word score and the projected Color-Word score (which is, in turn, based on the raw scores obtained in the Word and Color portions of the Test). Lower scores indicate poorer performance, and a positive percent change in T-scores indicates improved performance.|Baseline, Up to 2 hours|Only the subjects with tetraplegia who demonstrated sympathetic interruption (insignificant decreases in distal skin temperatures, distal microvascular blood flow (LDF) and decreases of 1.0°C or greater in Tcore during cool exposure), and their matched able-bodied controls were analyzed.|||Percent Change||Standard Deviation|Mean
2633641|NCT01822535|Primary|Visit 1: Percent Change in Core Body Temperature|We will test the effects of cool temperature (64°F) exposure, of up to 120 minutes, on the ability to maintain a constant body temperature (e.g., core temperature of 98.6°F) in persons with tetraplegia through comparing the percent changes in core body temperatures between groups from baseline to after cool exposure.|Baseline, Up to 2 hours|Only the subjects with tetraplegia who demonstrated sympathetic interruption (insignificant decreases in distal skin temperatures, distal microvascular blood flow (LDF) and decreases of 1.0°C or greater in Tcore during cool exposure), and their matched able-bodied controls were analyzed.|||Percent Change||Standard Deviation|Mean
2633642|NCT01822496|Secondary|Correlation Between Clinical Outcomes and Tumor Molecular Aberrations||Baseline|The data required for this analysis was not obtained and will not be obtained.||||||
2633643|NCT01822496|Secondary|Distant Progression-free Survival|Distant progression is defined as the first occurrence of distant metastasis. Distant progression-free survival time is measured from the date of randomization to the date of first distant progression, death, or last known follow-up (censored). Distant progression-free survival rates are estimated using the Kaplan-Meier method. No testing was done due to early study termination.|From randomization to study termination. Maximum follow-up was 39.0 months|Eligible patients|||Months||95% Confidence Interval|Median
2633644|NCT01822496|Secondary|Local-regional Progression-free Survival|Progression is defined using the RECIST guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new regional lesions. Local progression is defined as progression within the planning target volume (PTV). Regional progression is defined as progression outside of the PTV but within the same lobe of the lung as the primary tumor or in regional lymph nodes as defined by the American Joint Committee on Cancer (AJCC) 7th edition nodal stations. Local-regional progression-free survival time is measured from the date of randomization to the date of first local-regional progression, death, or last known follow-up (censored). Local-regional progression-free survival rates are estimated using the Kaplan-Meier method. No testing was done due to early study termination.|From randomization to study termination. Maximum follow-up was 39.0 months|Eligible patients|||Months||95% Confidence Interval|Median
2633645|NCT01822496|Secondary|Overall Survival|Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.|From randomization to study termination. Maximum follow-up was 39.0 months|Eligible patients|||Months||95% Confidence Interval|Median
2633646|NCT01822496|Secondary|Number of Patients With Grade 3-5 Adverse Events|Adverse events (AE) are graded using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|From randomization to study termination. Maximum follow-up was 39.0 months|Eligible patients who started study treatment|||Participants|||Count of Participants
2633647|NCT01822496|Secondary|Percentage of Patients With Complete or Partial Response|Per the RECIST guideline v1.1 complete response is defined as the disappearance of all target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. No statistical testing was done due to early study termination.|From randomization to study termination. Maximum follow-up was 39.0 months|Eligible patients with disease assessment|||percentage of participants||95% Confidence Interval|Number
2633692|NCT01822119|Secondary|Hearing Performance, Speech in Noise, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks|The change in hearing performance, speech in noise from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||Signal to noise ratio||Standard Deviation|Mean
2633648|NCT01822496|Primary|Progression-free Survival|Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions at any location. Progression-free survival time is measured from the date of randomization to the date of first progression, death, or last known follow-up (censored). No statistical testing was done due to early study termination.|From randomization to study termination. Maximum follow-up was 39.0 months|Eligible patients|||months||95% Confidence Interval|Median
2633649|NCT01822457|Secondary|Mood|Assessed using the Hospital Anxiety and Depression Scale score, participants reply that is closest to how they have been feeling in the past months. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Score 0 to 3, 3 - Most of the time, 0 - Not at all.|3 months|Data not collected||||||
2633650|NCT01822457|Secondary|Disease Specific Quality of Life|"Assessed using VascuQol (Vascular Quality of life) Questionnaire score, range from 0 to 24, and higher value indicates a better health status.~Each question has a four-point response scale (1 most problems - 4 no problems)"|12 months||||score on a scale||Inter-Quartile Range|Mean
2633651|NCT01822457|Secondary|Pain Free Treadmill Walking Distance|Standardised treadmill test - first recognition of pain as reported by the patient.|12 months||||Meters||Inter-Quartile Range|Mean
2633652|NCT01822457|Primary|Maximum Walking Distances|Standardised treadmill test at the end of the study period|12 months||||Meters||Inter-Quartile Range|Mean
2633653|NCT01822366|Other Pre-specified|Child-Guardian Relationship|Measured using the Child-Parent Relationship Scale (CPRS)|15 months|||||||
2633654|NCT01822366|Other Pre-specified|Child Functioning|Locally developed tool used to measure functional impairment and improvement over time.|15 months|||||||
2633655|NCT01822366|Other Pre-specified|Depression||15 months|||||||
2633656|NCT01822366|Secondary|Behavioral Difficulties|Measured using the Child Behavior Checklist (CBCL), Youth Self-Report (YSR), and items developed locally that are culturally specific.|15 months|||||||
2633657|NCT01822366|Primary|Childhood Traumatic Grief|Measured using the Inventory of Complicated Grief (ICG). Child report only. Scale range 0-112, with 112 representing extremely high grief symptomatology (worse outcome). 634 children and 634 caregivers (1268 total) analyzed at baseline and 3-month follow-up--includes all 1280 enrolled at baseline, minus 12 lost to follow-up.|15 months|Children from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban)|||Score on a scale||95% Confidence Interval|Mean
2633658|NCT01822366|Primary|Posttraumatic Stress Syndrome (PTSS)|Measured using the Child PTSD Symptoms Scale (CPSS). Caregiver and Child reported separately. Scale range 0-57, with 57 representing extremely high PTSS symptomatology (worse outcome). 634 children and 634 caregivers (1268 total) analyzed at baseline and 3-month follow-up--includes all 1280 enrolled at baseline, minus 12 lost to follow-up.|15 months|Children and Caregivers from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban)|||score on a scale||95% Confidence Interval|Mean
2633659|NCT01822353|Other Pre-specified|Effect of Treatment on Quality of Life|Quality of life is assessed by a questionnaire before and after immunotherapy.|one year|||||||
2633660|NCT01822353|Other Pre-specified|Safety of Oral Immunotherapy in Severe IgE Mediated Food Allergy in Adults.|How many of the patients have side effects (categorized as mild, moderate or severe)of the hyposensitisation and how many of the patients discontinue the therapy because of side effects?|One year|||||||
2633661|NCT01822353|Secondary|Does the Oral Immunotherapy Have en Effect on Airway Inflammation?|Does the oral immunotherapy change exhaled nitric oxide levels (measured before and after immunotherapy)|One year|||||||
2633662|NCT01822353|Secondary|Does Oral Immunotherapy Change Bronchial Hyperreactivity?|Does bronchial hyperreactivity (measured with methacholine bronchial challenge test) show change from the baseline level after the immunotherapy?|One year|||||||
2633663|NCT01822353|Secondary|Effect of Therapy on Lung Function.|Does hyposensitisation change lung function (do spirometry tests show difference from the baseline values (= before immunotherapy) after the immunotherapy) ?|One year|||||||
2633664|NCT01822353|Primary|Number of the Patients That Achieve Higher Tolerance of Allergen With Immunotherapy in One Year Than the Measured Baseline Allergen Challenge Shows.|Number of the patients that achieve higher tolerance of allergen with immunotherapy in one year than the measured baseline allergen challenge shows.|One year||||participants|||Number
2633665|NCT01822301|Secondary|Serial Computed Tomography Imaging|serial computed tomography images were collected to evaluate the volume of the defect|assessed at 7-21 days, 3 months and 9 months post op.||||volume, mL||Standard Deviation|Mean
2633666|NCT01822301|Primary|Facial Volume Score|the facial volume and appearance grading scale evaluates each aesthetic region in the face based on both physical examination and 3D photography by the clinician. scale ranges from 1-3 where a score of 1 indicates an obvious contour defect; 2 shows a noticeable improvement in contour but not sufficient to impart a normal appearance; 3 represents a normal appearance and/or close approximation with a normal uninjured contralateral structure.|assessed at baseline (pre-op), days 7-21 post-op, 3 months post-op, and 9 months post-op||||units on a scale||Standard Deviation|Mean
2633667|NCT01822223|Secondary|Mean Change in Millimeters of Clinical Attachment to the Abutment|A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|12 month post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.||||||
2633668|NCT01822223|Secondary|Mean Change in Millimeters of Clinical Attachment to the Abutment|A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|16 weeks post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.||||||
2633669|NCT01822223|Secondary|Mean Change in Millimeters of Clinical Attachment to the Abutment|A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|12 weeks post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.||||||
2633670|NCT01822223|Secondary|Mean Change in Millimeters of Clinical Attachment to the Abutment|A periodontal probe will be used to measure the level of clinical attachment to the abutment in millimeters. Measurements will be captured at 4 points around each abutment; mesial, buccal, distal, and lingual. All measurements were considered and the change in attachment level was assessed at each individual site. Data were reported as descriptive and were used to elucidate potential advantages and/or disadvantages of varying abutment types. These data were strictly confirmatory to the proof-in-principle histology presented in the report. Measures were taken at 8 weeks, 12 weeks, 16 weeks and 12 months to determine if attachment to one abutment type was more or less stable over time. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|8 weeks post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.||||||
2633671|NCT01822223|Secondary|Grams of Force Needed to Disrupt Tissue Attachment to the Abutment|A force transducing periodontal probe instrument will electronically capture the grams of force needed to disrupt the attachment to the implant abutment; tissues will be probed from the gingival margin to the alveolar bone crest at 4 points around each abutment and an adjacent tooth: measurements will be captured from the mesial, buccal, distal, and lingual. The specific force probe generates a descriptive graph that demonstrates the cumulative force and distribution necessary to disrupt the attachment of the gingival tissues to the abutment. These graphs were recorded, but were difficult to interpret and have not been reported.|8 weeks post-abutment placement|No data was collected on subjects from the mesial, buccal, distal or lingual sites as sites were not assessed on subjects for reasons unknown.||||||
2633672|NCT01822223|Primary|Number od Participants With Consistent Connective Tissue Integration at a Histologic Level|Connective tissue integration was assessed by radio graphic images of tissue and bone surrounding the implant.|8 weeks post-abutment placement|The number of participants entered represents measured data.|||participants|||Number
2633673|NCT01822197|Secondary|Quality of Life Scoring Post-Treatment (Day 7) and at Admission (Day 0|Quality of life scoring at admission (Day 0) and post-treatment (Day 7) using the CF questionnaire-revised (CFQ-R) as a measure of health related quality of life. Minimally important changes in CFQ-R scoring have been reported at 5-8. Days 0 and 7 will be compared. Score range is 0 to 100. Lower scores indicate worse quality of life.|between day 0 and day 7 of hospitalization||||units on a scale||Standard Deviation|Mean
2633674|NCT01822197|Secondary|Depressive Symptom Scores Post-Treatment (Day 7) and at Admission (Day 0)|depressive symptom scoring at day 0 and day 7 using Quick Inventory of Depressive Symptomatology-clinician (QIDS-C) and Quick Inventory of Depressive Symptomatology self-report (QIDS-SR). Day 7 and Day 0 scores will be compared. Score range is 0 to 27. A QIDS score of less than 6 indicates no depression, 6-10 indicates mild depression, 11-15 moderate, 16-20 severe, and 21- 27 very severe depression.|between day 0 and day 7 of hospitalization||||units on a scale||Standard Deviation|Mean
2633675|NCT01822197|Primary|Length of Hospitalization|Length of stay will be measured in days|participants will be followed for the length of hospital stay, an average of 14 days||||days||Standard Deviation|Mean
2633676|NCT01822132|Secondary|Methamphetamine Use|"Participants were asked How many days in the past 30 days did you use methamphetamine?. This is a self-report measure."|28 days post drug intervention|Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days.|||days||Standard Deviation|Mean
2633691|NCT01822119|Secondary|Abbreviated Profile of Hearing Aid Benefit (APHAB)|Change of APHAB scoring from the unaided pre-operative situation to the aided situation with Baha Attract at 36 weeks. APHAB questionnaire is a 24-item self-assessment inventory that evaluates the benefit experienced by the patient when using hearing amplification compared to the unaided situation. APHAB produces a Global score and scores for four subscales: ease of communication (EC), reverberation (RV), background noise (BN), and aversiveness (AV). The absolute APHAB scale is between 0 and 100%, where 0% indicates no problem and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment. This scale applies to all reported scores.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||units on a scale||Standard Deviation|Mean
2633677|NCT01822132|Primary|Risk Assessment Battery (RAB)|"The Risk Assessment Battery (RAB) is a 26 question self-administered assessment focusing on drug use, injection and sexual risk during the past 30 days.~Three composite HIV risk scores (drug, sex, and total score) are calculated. The questions have different numbers of items, and scores for a single question can range from 0 to 7, with higher values reflecting more instances of risk behavior. The drug risk score has a range of 0 to 22 and is calculated from 8 questions that address recent substance use, including frequency, needle sharing, and cleaning of the works. 9 questions are used to calculate a sex risk score that has a range of 0 to 18, and these questions address the frequency and types of sexual behavior, HIV status of sexual partners, and type of protection that was used (if any). Total score is calculated by adding drug and sex scores and dividing by 40, the maximum score possible, and ranges from 0 to 40 where higher scores indicate greater risk behavior."|28 days post drug intervention|Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days.|||score on a scale||Standard Deviation|Mean
2633678|NCT01822132|Primary|Barrat Impulsiveness Scale (BIS)|The Barrat Impulsiveness Scale (BIS) is a 30 item questionnaire to measure a persons impulsiveness. Items are answered on a 4-point scale and scored 1-4 then summed across responses. Total scores range from 30-120 with a higher summed score indicating higher impulsivity.|28 days post drug intervention|Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days.|||score on a scale||Standard Deviation|Mean
2633679|NCT01822132|Primary|Discounting Tasks: Standard Delay Discounting (DD)|Monetary delay discounting task consisted of choosing between a larger, delayed and a smaller, immediate reward. A hyperbolic decay model was used to calculate k, a free parameter that indexes the rate of delay discounting. As k values are typically skewed across subjects, the distribution of k was normalized by using a natural log transformation. The normalized values are reported here. If k typically ranges between 0.5 and 10^-5, then the natural log of k will range between -0.69 and -11.5. Larger normalized k values indicate a preference for smaller sooner outcomes (i.e., more impulsive decision-making).|28 days post drug intervention|Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days.|||natural log||Standard Deviation|Mean
2633680|NCT01822132|Primary|Discounting Tasks: Sexual Probability Discounting (SexPD)|"In the SexPD task, subjects are asked to choose between having sex with a more appealing partner with a varying chance of having a sexually transmitted infection (STI) or a less appealing partner with no STI.~A hyperbolic decay model was used to calculate h, a free parameter that indexes the rate of probabilistic discounting. Smaller h values indicate a preference for probabilistic (i.e., riskier) outcomes. To normalize the data, the natural log of h values were calculated and reported here."|28 days post drug intervention|Subjects with methamphetamine dependence and either HIV positive or not, all abstaining from opioids for at least 30 days.|||natural log||Standard Deviation|Mean
2633681|NCT01822119|Other Pre-specified|Safety; Numbness|Evaluation of numbness by asking the patients if they had experienced any numbness within 2 cm from the centre of the implant magnet or within and beyond 2 cm from the centre of the implant magnet.|36 weeks|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||participants|||Number
2633682|NCT01822119|Other Pre-specified|Safety; Pain|Evaluation of neuropathic pain or pain in the scar the last week by asking the patients to rate their experience on a scale from 1 (no, not at all) to 10 (yes, very much).|36 weeks|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||units on a scale||Standard Deviation|Mean
2633683|NCT01822119|Other Pre-specified|Safety; Skin Evaluation|Evaluation of the skin using the Patient and Observer Scar Assessment Scale (POSASa scale from 1 (normal skin) to 10 (worst scar imaginable).|36 weeks|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||units on a scale||Standard Deviation|Mean
2633684|NCT01822119|Other Pre-specified|Magnetic Force|To investigate if the magnetic force required for sound processor magnet retention will change over time|Week 4, 6, 12 and 36|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||Newton||Standard Deviation|Mean
2633685|NCT01822119|Other Pre-specified|Feedback Measurement, BP110|Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. Feedback is a measure of how much sound from the actuator (vibrator) returns to the microphones thus creating a loop of sound which sounds like high pitch noise. Measuring this is a part of the performance of the system, i.e how much gain can the sound processor produce before feedback occurs. Unit of measure is dB re output. A negative value of the change means less feedback.|Baseline before surgery and 12 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||dB||Standard Deviation|Mean
2633686|NCT01822119|Other Pre-specified|Feedback Measurement, BP100|Difference between softband measurement at visit 1 and measurement with the Baha Attract system at visit 6. Feedback is a measure of how much sound from the actuator (vibrator) returns to the microphones thus creating a loop of sound which sounds like high pitch noise. Measuring this is a part of the performance of the system, i.e how much gain can the sound processor produce before feedback occurs. Unit of measure is dB re output. A negative value of the change means less feedback.|Baseline before surgery and 12 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||dB||Standard Deviation|Mean
2633687|NCT01822119|Other Pre-specified|Choice of Sound Processor|Type of sound processors BP100 and BP110 attached to a soft band (subject preference)|Baseline|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||participants|||Number
2633688|NCT01822119|Other Pre-specified|Implant Stability|Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability.|Visit 2 (surgery)|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||units on a scale||Standard Deviation|Mean
2633689|NCT01822119|Other Pre-specified|Tissue Reduction Performed During Surgery|Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm.|Visit 2 (surgery)|Intention-to-Treat population, includes all patients who received surgical intervention.|||participants|||Number
2633690|NCT01822119|Other Pre-specified|Time to Perform Surgery||Visit 2 (surgery)|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||minutes||Standard Deviation|Mean
2633693|NCT01822119|Secondary|Hearing Performance, Speech in Noise, Unaided Versus Baha Attract at 36 Weeks|The change in hearing performance, speech in noise from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||Signal to noise ratio||Standard Deviation|Mean
2633694|NCT01822119|Secondary|Hearing Performance, Speech in Quiet, Aided With the Sound Processor on a Softband Versus Baha Attract at 36 Weeks|The change in hearing performance, speech in quiet from the pre-operative aided situation with the Sond Processor on a softband to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||% perception of presented words||Standard Deviation|Mean
2633695|NCT01822119|Secondary|Hearing Performance, Speech in Quiet, Unaided Versus Baha Attract at 36 Weeks|The change in hearing performance, speech in quiet from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||% perception of presented words||Standard Deviation|Mean
2633696|NCT01822119|Secondary|Hearing Performance, Individual Frequencies, Sound Processor on Softband Versus Baha Attract at 36 Weeks|The change in pure-tone thresholds in free field measured by the difference in hearing levels of individual frequencies from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||dB||Standard Deviation|Mean
2633697|NCT01822119|Secondary|Hearing Performance, PTA4, Sound Processor on Softband Versus Baha Attract at 36 Weeks|The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative aided situation with the Sound Processor on a softband to the aided situation with Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat population, includes all patients who received surgical intervention.|||dB||Standard Deviation|Mean
2633698|NCT01822119|Secondary|Hearing Performance, Individual Frequencies|The change in pure-tone thresholds in free field measured by the difference at individual frequencies from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||dB||Standard Deviation|Mean
2633699|NCT01822119|Primary|Hearing Performance, PTA4 at 36 Weeks|The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 36.|Baseline before surgery and 36 weeks after surgery||||dB||Standard Deviation|Mean
2633700|NCT01822119|Primary|Hearing Performance, PTA4 at 12 Weeks|The change in pure-tone thresholds in free field measured by the difference in pure tone average PTA4 (Mean of thresholds at 500, 1000, 2000 and 4000 Hz) from the pre-operative unaided condition to the aided situation with the Baha Attract System at week 12.|Baseline before surgery and 12 weeks after surgery|Intention-to-Treat (ITT) population, includes all patients who received surgical intervention.|||dB||Standard Deviation|Mean
2633701|NCT01821963|Secondary|Sustained Virological Response (SVR)|Sustained virological response (SVR) defined as a single undetectable HCV-RNA measurement 12 weeks after the 48-week treatment period for those still waiting for transplantation. The treatment duration will be summarized with descriptive statistics. Additional analyses based on evaluable patients also conducted regarding the PTVR response rate. The evaluable patients are defined as those patients who complete at least 16 weeks of treatment and have the 12 weeks post-transplant response measurement. The rate will also be computed stratified by the HCV treatment time (i.e., the 48-week HCV treatment versus less than 48 week HCV treatment) considering the different times under HCV. The SVR rate will be estimated, along with the exact 95% confident interval.|60 weeks|||||||
2633702|NCT01821963|Primary|Number of Participants With Undetectable Viral Load 12 Weeks Post-transplant|"The primary endpoint is number of participants with undetectable viral load at 12 weeks post-transplant (Post-transplant virological response, (PTVR)) which is defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) 12 weeks after liver transplantation). In order to have undetectable HCV RNA viral load after transplant, participants need to have undetectable viral load before the liver transplant.~Response rate based on the modified intent-to-treat (ITT) population where ITT population is defined as those patients who have achieved an undetectable HCV-RNA level before the transplant. If patients drop out the study early due to severe toxicity or treatment failure including treatment-related death, they will be counted as non-responders when evaluating the response rate."|12 weeks post-transplant, up to 48 weeks for overall monitoring|Study terminated early with one participant. No analysis possible.||||||
2633703|NCT01821937|Secondary|Tmax,ss (After Multiple Dosing)|tmax,ss is defined as the time from last dosing to the maximum measured concentration of Faldaprevir in plasma at steady state|Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .|||hour||Geometric Coefficient of Variation|Geometric Mean
2633704|NCT01821937|Secondary|t(1/2,ss) (After Multiple Dosing)|t(1/2,ss) is defined as the terminal half-life of Faldaprevir in plasma at steady state.|Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .|||hour||Geometric Coefficient of Variation|Geometric Mean
2633760|NCT01821118|Secondary|Number of Participants With Significant Changes in Neurological Examination Results|A complete/full neurological examination included assessment of the cranial nerves; muscle strength, tone, cortical drift, abnormal movements; deep tendon reflexes; sensory exam, coordination, gait and station.|Baseline up till Day 240|All 36 participants who received study drug were included in the analysis.|||participants|||Number
2633705|NCT01821937|Secondary|AUC(0-tz) (After Single Dosing)|AUC (0-tz) is defined as area under the concentration-time curve of the analyte in plasma over the respective time interval, where t and z define beginning and end times of the time interval.|Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2633706|NCT01821937|Secondary|Cmax (After Single Dosing)|Cmax is defined as maximum measured concentration of Faldaprevir in plasma.|Before drug administration and 0.5 hours(h), 1,1.5,2,3,4,6,8,12,24,48,72,96h after administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2633707|NCT01821937|Primary|AUC(Tau,ss) (After Multiple Dosing)|AUC(tau,ss) is defined as area under the concentration-time curve of Faldaprevir in plasma at steady state over a uniform dosing interval tau.|Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228,240 h after first administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one PK endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2633708|NCT01821937|Primary|Cmax,ss (After Multiple Dosing)|C(max,ss) is defined as maximum measured concentration of Faldaprevir in plasma at steady state over a uniform dosing interval tau.|Before drug administration and 24 hours(h), 48,72,96,120,144,168,192,216,216.5,217,218,219,220,222,224,228, 240 h after first administration of Faldaprevir|Pharmacokinetic analysis set (PKS): This set included all subjects in TS who provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of PK and provided no emesis with onset at or before twice the median t max .|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2633709|NCT01821859|Primary|Number of Participants With Progression Free Survival Rate at 6 Months as Defined as Complete Response, Partial Response, or Stable Disease.|Using RECIST criteria, Complete Response (CR)= disappearance of all target lesions, Partial Response (PR)= At least a 30% decrease in the sum of the longest diameter of target lesions, and Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease.|6 months after start of dosing|||||||
2633710|NCT01821807|Secondary|Backache in Patients Receiving Spinal Anesthesia for Cesarean Section|Patients were observer for the symptoms of postdural puncture backache for 1 week. On the 1st postoperative day they were visited in the clinic. On the 7th postoperative day they were contacted by telephone and were asked about the symptoms.|1 week||||participants|||Number
2633711|NCT01821807|Primary|Postdural Puncture Headache in Patients Receiving Spinal Anesthesia for Cesarean Section|Patients were observer for the symptoms of headache (PDPH) for 1 week. On the 1st postoperative day they were visited in the clinic. On the 7th postoperative day they were contacted by telephone and were asked about the symptoms.|1 week||||participants|||Number
2633712|NCT01821729|Secondary|To Measure Utilization of Health Services|To measure utilization of health services (ER, hospital and ICU visits) in the study population|2 years|||||||
2633713|NCT01821729|Secondary|Describe Quality of Life, Symptom Burden and Mood|Describe quality of life, symptom burden and mood in the study population|2 years|||||||
2633714|NCT01821729|Secondary|Determine Correlation Between Circulating Biomarkers and Outcome|To determine the correlation between circulating biomarkers of TGF-B1 downregulation, including circulating Collagen I levels, and outcome in locally advanced pancreatic cancer treated with FOLFIRINOX-Losartan +/- proton beam radiation/capecitabine.|2 years|||||||
2633715|NCT01821729|Secondary|Determine Correlation of Somatic Gene Mutations and Outcome|To determine the correlation between a panel of somatic genetic mutations (SNaPSHOT) and outcome in locally advanced pancreatic cancer treated with FOLFIRINOX-Losartan +/- proton beam radiation/capecitabine|2 years|||||||
2633716|NCT01821729|Secondary|Rate of Downstaging|To determine the rate of downstaging to surgical resection of FOLFIRINOX-Losartan followed by proton radiation in patients with locally advanced pancreatic cancer|2 years|||||||
2633717|NCT01821729|Secondary|Determine Toxicity of FOLFIRINOX-Losartan and Proton Beam Radiation|To determine the toxicity of FOLFIRINOX-Losartan and proton beam radiation in patients with locally advanced pancreatic cancer.|2 years|||||||
2633718|NCT01821729|Secondary|Determine Toxicity FOLFIRINOX-Losartan|To determine the toxicity of FOLFIRINOX-Losartan in patients with locally advanced pancreatic disease|2 years|||||||
2633719|NCT01821729|Secondary|Overall Survival for FOLFIRINOX Without Proton Radiation|To determine the overall survival of patients with locally advanced disease who receive FOLFIRINOX-Losartan without proton radiation (i.e. patients who demonstrate progression at restaging)|2 years|||||||
2633720|NCT01821729|Secondary|Overall Survival for FOLFIRINOX + Proton Beam Radiation|To determine overall survival in patients treated with preoperative FOLFIRINOX and proton beam radiation therapy|2 years|||||||
2633721|NCT01821729|Secondary|Progression-Free Survival|"To determine the progression free survival of patients with locally advanced disease who receive FOLFIRINOX-Losartan and proton beam radiation therapy. Disease progression was assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1).~Progressive disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesion, taking as reference the smal lest sum LD recorded since the treatment started or the appearance of one or more new lesions (new lesions must be > slice thickness)."|From the start of treatment until death or progression, median duration of 17.5 months||||Months||95% Confidence Interval|Median
2633722|NCT01821729|Primary|Number of Participants With R0 Resection|The number of participants that received treatment with proton radiation along with FOLFIRINOX-Losartan and then subsequently underwent attempted surgery and achieved R0 resection. R0 resection means that no cancer cells were seen microscopically at the resection margin.|At the time of surgery (approximately 4 months after the start of treatment)||||Participants|||Count of Participants
2633723|NCT01821625|Primary|Percentage of Study Patients Completing Antiviral Therapy, as Per Boceprevir Prescribing Guidelines.|"The length of therapy will depend on several factors:~Study patient's liver disease status.~Study patient's antiviral response.~Study patient's tolerance to treatment.~One patient completed therapy and experienced a sustained viral response.~A minimum full course of treatment will be 30 weeks, with a maximum of 56 weeks of treatment."|Up to 56 weeks||||Participants|||Count of Participants
2633724|NCT01821560|Primary|Cigarettes Smoked Per Day|Cigarettes per day at Scan Day 2; Baclofen group vs. placebo group|3 weeks (Scan Day 1, week1- Scan Day 2, week 4)||||Cigarettes per day||Standard Error|Mean
2633725|NCT01821534|Primary|Intra-rater Reliability Using a LFSC|The LFSC is a qualitative tool to assess facial shape into one of 5 categories (A, B, C, D, and E). Intra-rater (within raters) reliability was calculated using Kappa statistics. Kappa statistics were calculated for each of the 8 physician raters. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.|Day 1|Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1|||Kappa statistics||95% Confidence Interval|Number
2633726|NCT01821534|Primary|Inter-rater Reliability Using a Lower Facial Shape Classification (LFSC)|The LFSC is a qualitative tool to assess facial shape into one of 5 categories (A, B, C, D, and E). Inter-rater (among raters) reliability was calculated using Kappa statistics. Kappa statistics were calculated for each of the 5 facial categories. A total of 8 physicians rated each subject. The overall inter-rater agreement for Kappa statistics for all categories combined was estimated by pooling Kappa statistics for each category using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.|Day 1|Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1|||Kappa Statistics||95% Confidence Interval|Number
2633727|NCT01821534|Primary|Intra-rater Reliability Using a MMPS|The MMPS is an ordinal tool to assess the masseter muscle prominence (jaw muscle) for each side of the face from 1 = minimal to 5 = very marked. Intra-rater (within raters) reliability was calculated separately for the left and right side of the face using weighted Kappa statistics. Weighted Kappa statistics were calculated for each of the 8 physician raters. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kappa statistics is provided.|Day 1|Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1|||Kappa statistics||95% Confidence Interval|Number
2633728|NCT01821534|Primary|Inter-rater Reliability Using a Masseter Muscle Prominence Scale (MMPS)|The MMPS is an ordinal tool to assess the masseter muscle prominence (jaw muscle) for each side of the face from 1=minimal to 5=very marked. Inter-rater (among raters) reliability was calculated separately for the left and right side of the face using Kendall's coefficient of concordance (Kendall's W). Kendall W statistics overall for the left and right sides of the face were derived using the average of assessment 1 and assessment 2 rounded to the nearest whole integer for each subject and each clinician. A total of 8 physicians rated each subject. The degree of agreement of the point estimates of Kendall's W was interpreted according to the reference range scale that was pre-defined as: ≤0: poor, >0 to ≤0.2: slight, >0.2 to ≤0.4: fair, >0.4 to ≤0.6: moderate, >0.6 to ≤0.8: substantial, and >0.8 to ≤1.0: almost perfect. The 95% confidence interval for Kendall's W is provided.|Day 1|Reliability population: all subjects with at least assessment 1 performed by at least 1 in-person rater on day 1|||Kendall's W||95% Confidence Interval|Number
2633729|NCT01821417|Secondary|Millimeters of Periodontal Pocket Depth Surrounding the Dental Implant Device|Probing pocket depth (PD) is measured from the mucosal sulcus to the depth of the pocket attachment after implant restoration.|1 year after placement|No data was collected. Previously entered data was entered incorrectly.||||||
2633730|NCT01821417|Secondary|Changes in Peri-implant Gingivitis Score|Measurement of changes in peri-implant gingivitis score [Loe and Silness gingival index (GI)] after implant restoration|1 year after placement|No data was collected. Previously entered data was entered incorrectly.||||||
2633731|NCT01821417|Primary|Change in Millimeters of Bone Loss Surrounding the Implant Device|Using radiographic images and image-processing software, measurements of bone height at the mesial and distal of each implant will be captured in millimeters.|Implant insertion, 12 months post-insertion||||millimeters||Standard Deviation|Mean
2633732|NCT01821378|Secondary|Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the CGI-S Score|"The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes.~Reason for the discrepancy of the LS mean (SE) for placebo in outcome 2 and outcome 9 is because the different MMRM model used in outcome 2 and outcome 9. The treatment groups included in the MMRM model for outcome 2 are placebo, lurasidone 20 mg, and lurasidone 80-160 mg. The treatment groups included in the MMRM model for outcome 9 are placebo, ENR lurasidone 80 mg, and ENR lurasidone 160 mg."|baseline to week 6|ENR (early non-responders) Intent to treat (ITT) population: of the 199 subjects who randomized to 80 mg group, only 95 subjects are early non-responders at week 2, therefore they are included in the ENR ITT population (Lurasidone 20 mg subjects are not included in the ENR ITT population).|||units on a scale||Standard Error|Least Squares Mean
2633761|NCT01821118|Secondary|Number of Participants With Significant Changes From Baseline in Physical Examination at Final Visit|A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, skeletal, and neurological systems.|Baseline up to Final Visit (Day 240)|All 36 participants who received study drug were included in the analysis.|||participants|||Number
2633733|NCT01821378|Secondary|Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the PANSS Total Score|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|Baseline to week 6|ENR (early non-responders) Intent to treat (ITT) population: of the 199 subjects who randomized to 80 mg group, only 95 subjects are early non-responders at week 2, therefore they are included in the ENR ITT population (Lurasidone 20 mg subjects are not included in the ENR ITT population).|||units on a scale||Standard Error|Least Squares Mean
2633734|NCT01821378|Other Pre-specified|Change From Baseline to Week 6 for the Lurasidone 20 mg and Lurasidone 80 - 160 mg Groups Compared to the Placebo Group in the Euroqol (EQ-5D) Index Score|The EQ-5D is a standardized measure of health state consisting of two parts: a) EQ-5D measuring mobility, self-care, pain/discomfort, usual activities, and anxiety/depression on a 0 2 scale with lower scores indicating improvement, and b) a 20-cm visual analogue scale (VAS) for health status rating on a 0-100 scale with higher scores indicating improvement. EQ-5D health states, defined by the EQ-5D descriptive system, may be converted into a single summary index (i.e. the EQ-5D index score) by applying a formula that essentially attaches values (also called weights) to each of the levels in each dimension. The EQ-5D Index scores ranged from -0.429 to 1.000. Generally higher observed EQ-5D Index scores indicate a better degree of health.|6 weeks|Intent to treat population: there are only 368 subjects who had at least one post-baseline Euroqol (EQ-5D) assessments.|||units on a scale||Standard Error|Least Squares Mean
2633735|NCT01821378|Secondary|Change From Week 2 to Week 6 for ENR Lurasidone 80 mg vs. ENR Lurasidone 160 mg in CGI-S Score|The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale (0-7), where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes.|week 2 to week 6|ENR Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
2633736|NCT01821378|Other Pre-specified|Change From Baseline to Week 6 for the Lurasidone 20 mg and Lurasidone 80 - 160 mg Groups Compared to the Placebo Group in the GAF Score|The GAF is a numeric scale (0 through 100) that measures a patient's overall level of psychological, social, and occupation functioning. It is designed to guide clinicians through a methodical and comprehensive consideration of all aspects of a patient's symptoms and functioning. The scale begins at 100 - superior functioning - to 0 - inadequate information.|6 Weeks|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
2633737|NCT01821378|Secondary|Change From Baseline to Week 6 for the ENR Lurasidone 80mg and ENR Lurasidone 160mg Groups vs the Placebo in the MADRS Total Score|"The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity."|baseline to week 6|ENR (early non-responders) Intent to treat (ITT) population: of the 199 subjects who randomized to 80 mg group, only 95 subjects are early non-responders at week 2, therefore they are included in the ENR ITT population (Lurasidone 20 mg subjects are not included in the ENR ITT population).|||units on a scale||Standard Error|Least Squares Mean
2633738|NCT01821378|Secondary|Change From Week 2 to Week 6 for the ENR (Early Non-responders) Lurasidone 160mg Group vs the ENR (Early Non-responders) Lurasidone 80 mg Group in the Following: PANSS Total Score|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|week 2 to week 6|ENR (early non-responders) Intent to treat (ITT) population: of the 199 subjects who randomized to 80 mg group, only 95 subjects are early non-responders at week 2, therefore they are included in the ENR ITT population.|||units on a scale||Standard Error|Least Squares Mean
2633739|NCT01821378|Secondary|Proportion of Subjects Who Achieve a Response, Defined as 20% or Greater Improvement From Baseline in Positive and Negative Syndrome Score (PANSS) Total Score at Week 6|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|6 Weeks|Intent to treat population|||percentage of participants|||Number
2633740|NCT01821378|Secondary|Change From Baseline to Week 6 for the Lurasidone 20 mg, and Lurasidone 80 - 160 mg Groups Versus the Placebo Group in the Montgomery-Asberg Depression Rating Scale Total Score|"The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity."|Baseline to 6 Weeks|Intent to treat population - only 379 subjects had at least one post-baseline MADRS assessment.|||units on a scale||Standard Error|Least Squares Mean
2633741|NCT01821378|Secondary|Change in Clinical Global Impression-Severity of Illness (CGI-S) Score at Week 6 for Lurasidone 20 mg and 80-160 mg Versus Placebo.|The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale (0-7), where a higher score is associated with greater illness severity. Following a clinical interview, the CGI-S can be completed in 1-2 minutes.|Baseline to 6 Weeks|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
2633742|NCT01821378|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 for Lurasidone 20 mg and 80-160 mg Versus Placebo.|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|Baseline to 6 Weeks|Intent to treat population - there was one subject randomized but not treated with study medication, therefore excluded from ITT population|||units on a scale||Standard Error|Least Squares Mean
2633743|NCT01821352|Primary|Change in Combined Circumference Measurement|Individual measurements in inches of the waist, hips and upper abdomen were combined to calculate a total combined body circumference measurement. Change in combined circumference measurement is calculated as the difference in circumference measurements from baseline to endpoint (4 weeks). A negative (-) change indicates a decrease in circumference and is positive for study success. A positive (+) change indicates an increase in circumference and is negative for study success.|Baseline and 4 Weeks||||inches||Standard Deviation|Mean
2633744|NCT01821352|Other Pre-specified|Subject Satisfaction With Procedure Outcome|"Subjects rated satisfaction with the outcome of the study procedures with respect to change in body shape on the following 5-point scale: Very Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Not Very Satisfied, Not at All Satisfied.~Results are reported as the number of subjects in each treatment group who rated study outcome satisfaction as 'Very Satisfied' or 'Somewhat Satisfied'."|4 Weeks||||participants|||Number
2633745|NCT01821352|Primary|Difference in the Proportion of Primary Outcome Successes Between Treatment Groups for Change in Combined Circumference Measurements|Individual measurements in inches of the waist, hips and upper abdomen were combined to calculate a total body circumference measurement. Change in combined circumference measurement from baseline to 4 weeks was calculated for each subject. Individual subject success was defined as a change of 3.0 inches or more in the combined circumference measurement across the evaluation period. A decrease in combined circumference measurement is positive for individual subject success. An increase in combined circumference measurement is negative for individual subject success. Overall study success was defined as a 40% or greater difference between the proportion of individual successes in each treatment group.|Baseline and 4 Weeks||||participants|||Number
2633746|NCT01821326|Primary|Rebleeding Rate||10 years||||participants|||Number
2633747|NCT01821300|Secondary|Health Related Quality of Life - IWQOL|Parent perception of the effects of weight on his/her child's QOL was assessed with a caregiver-proxy version of the Impact of Weight on Quality of Life - Kids (IWQOL-Kids) questionnaire. The IWQOL-Kids is a validated, 27-item, self-report measure of weight-related QOL for youth ages 11-19 years. It yields 4 subscales (Physical Comfort, Body Esteem, Social Life, and Family Relations) and a Total score, which have strong psychometric properties, discriminate among weight status groups, and are responsive to weight change. Scaled scores are standardized and range from 0 to 100, with greater scores representing better weight-related QOL.|Study Visit 1||||score on a scale||Standard Deviation|Mean
2633748|NCT01821300|Secondary|Health Related Quality of Life - PedsQL|Caregiver-perception of his/her child's health-related QOL was assessed with the use of the parent-proxy report of the Pediatric Quality of Life Inventory (PedsQL) Version 4.0. Sub-scale scores are converted to a 0-100 scale so that greater scores indicate better QOL. Scale scores are computed as the sum of the items divided by the number of items answered (this accounts for missing data). If more than 50% of the items in the scale are missing, the scale score is not computed. The Physical Health Summary Score (8 items) is the same as the Physical Functioning Scale. To create the Psychosocial Health Summary Score (15 items), the mean is computed as the sum of the items divided by the number of items answered in the Emotional, Social, and School Functioning Scales.|Study Visit 1||||score on a scale||Standard Deviation|Mean
2633749|NCT01821300|Primary|Pulse Wave Velocity|Cardiac end organ injury assessed by Pulse Wave Velocity (PWV)|Study Visit 1|PWV was available in 129 adolescents with DS and 97 controls|||m/s||Inter-Quartile Range|Median
2633750|NCT01821300|Primary|Left Ventricular Mass|Cardiac end organ injury assessed by echocardiography. Left Ventricular Mass (LVM) was measured by area/length method using the apical four-chamber and parasternal short-axis views. LVM was calculated as LV area × LV length × 1.05 × 5/6.|Study Visit 1|LVM was available in 136 adolescents with DS (60M/76F) and 101nonDS controls (41M/60F).|||g||Inter-Quartile Range|Median
2633751|NCT01821300|Primary|Body Mass Measures|Adiposity measured by Dual-energy X-ray absorptiometry|Study Visit 1||||g||Inter-Quartile Range|Median
2633752|NCT01821300|Primary|Visceral Fat|Adiposity measured by Dual-energy X-ray absorptiometry|Study Visit 1||||cm^2||Inter-Quartile Range|Median
2633753|NCT01821300|Primary|Abnormal Glucose Tolerance|Impaired fasting glucose (IFG) was defined as fasting glucose ≥ 100 mg/dl. Impaired glucose tolerance (IGT) was defined as 2-hour glucose 140-199 mg/dl measured as part of an oral glucose tolerance test.|Study Visit 1|Participants completed an oral glucose tolerance test if they were in the overweight or obese categories: DS n=96, Control n=64.|||Participants|||Count of Participants
2633754|NCT01821300|Primary|Cardiometabolic Risk Biomarker Proteins|hs-CRP, PAI-1, and IL-6 run on samples from fasting blood drawn Study Visit 1.|Study Visit 1|Participants excluded from analysis if they failed to complete blood draw or were diagnosed with Type 1 Diabetes: DS=7, Controls=0.|||ng/dL||Inter-Quartile Range|Median
2633755|NCT01821300|Primary|Insulin Resistance|Insulin Resistance (HOMA-IR) was calculated as [fasting insulin (uIU/mL) x fasting glycemia (mmol/L)]/22.5|Study Visit 1|Participants excluded from insulin resistance analysis if they failed to complete blood draw or were diagnosed with Type 1 Diabetes: DS=147, Controls=103.|||HOMA-IR||Inter-Quartile Range|Median
2633756|NCT01821300|Primary|Lipid Subparticles (Size)|Lipoprotein subclass particle analysis run on samples from fasting blood drawn Study Visit 1.|Study Visit 1|Participants excluded from lipid analysis if they failed to complete blood draw or were diagnosed with Type 1 Diabetes: DS=7, Controls=0.|||nm||Inter-Quartile Range|Median
2633757|NCT01821300|Primary|Lipid Subparticles|Lipoprotein subclass particle analysis run on samples from fasting blood drawn Study Visit 1.|Study Visit 1|Participants excluded from lipid analysis if they failed to complete blood draw or were diagnosed with Type 1 Diabetes: DS=7, Controls=0.|||nmol/L||Inter-Quartile Range|Median
2633758|NCT01821300|Primary|Non-HDL Cholesterol|Non-HDL cholesterol measured via fasting blood draw|Study Visit 1|Participants excluded from lipid analysis if they failed to complete blood draw or were diagnosed with Type 1 Diabetes: DS=7, Controls=0|||mg/dl||Inter-Quartile Range|Median
2633759|NCT01821118|Secondary|Number of Participants With Anti-PF-04360365 Antibodies|Blood samples were collected from participants who received active treatment to assess for presence/absence of anti-PF-04360365 antibodies.|Day 1 up to Day 240|All 24 participants who received PF-04360365 were included in this analysis.|||participants|||Number
2635701|NCT01800201|Primary|1 -Year Survival Probability Rate: Vascular Readmissions or Death|Primary outcome variable(s): 1- year survival probability rate for vascular inpatient readmission or death|Date of enrollment + 12 months||||proportion of participants|||Number
2633762|NCT01821118|Secondary|Overall Number of Participants With Positive Responses to Questions on the Columbia Suicide Severity Rating Scale (C-SSRS)|"C-SSRS assessed whether participant responded yes to the following: completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, self-injurious behavior with no suicidal intent."|Baseline up to Day 240|All 36 participants who received study drug were included in the analysis.|||participants|||Number
2633763|NCT01821118|Secondary|Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria|Categorical summarization criteria in vital signs included: supine systolic blood pressure (SBP) of less than (<)90 millimeters of mercury (mm Hg) or more than (>) 160 mm Hg; supine diastolic blood pressure (DBP) <50 mm Hg or >100 mm Hg; supine pulse rate of <60 beats per minute (bpm) or >100 bpm; maximum changes (increase or decrease) from baseline in supine SBP of >=20 mm Hg; maximum increase from baseline in supine DBP of >=20 mm Hg; and maximum decrease from baseline in supine DBP of >=10 mm Hg.|Baseline up to Day 240|All 36 participants who received study drug were included in the analysis.|||participants|||Number
2633764|NCT01821118|Secondary|Number of Participants With Laboratory Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, liver function (including Hy's Law Criteria), renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy).|Baseline up to Day 240|All 36 participants who received study drug were included in the analysis.|||participants|||Number
2633765|NCT01821118|Secondary|Number of Participants With All Causality and Treatment-related Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events (TEAEs) were defined as newly occurring AEs or those worsening after first dose.|Baseline up to Day 240|All 36 participants who received study drug were included in the AE summarization/analysis.|||participants|||Number
2633766|NCT01821118|Secondary|Mean Montreal Cognitive Assessment (MoCA) Total Score Over Time|The Montreal Cognitive Assessment (MoCA) was used as a safety outcome measure to assess any changes in cognition. The MoCA is a 1-page 30-point test administered in approximately 10 minutes. The MoCA assessed short term memory, visuospatial abilities, multiple aspects of executive functions, attention, concentration, working memory, and language, as well as orientation to time and place. The total scale ranges from 0 to 30, with lower numbers indicating lower cognition performance.|Screening; Days 0, 1, 30, 60, 90, and 240|All 36 participants who received study treatment were included in the analysis. On Day 240, the number of evaluable participants in the placebo group was 11 instead of 12.|||units on a scale||Standard Deviation|Mean
2633767|NCT01821118|Secondary|Number of Participants With Brain Structural Magnetic Resonance Imaging (sMRI) Abnormalities|"Brain sMRI abnormalities included cerebral edema and total infarcts (including cortical infarcts, white matter infarcts, and subcortical gray matter infarcts). Total infarcts is the total number of participants with at least 1 type of infarct."|Baseline/Screening, Day 15, Day 45, Day 90,|All 36 participants who received study treatment were analyzed for this endpoint.|||participants|||Number
2633768|NCT01821118|Secondary|Change From Baseline in Concentration of Total Plasma Amyloid Beta (AB)|Cerebral amyloid angiopathy (CAA) is caused by the progressive deposition of amyloid, predominantly AB40, within the walls of cerebral blood vessels with a predisposition for the vessels of the occipital lobe. As such, it is of interest to investigate the effect of PF-04360365 on AB concentrations. AB1-x and AB1-40 were investigated.|Baseline, 8 hours post dose on Day 1, Day 2, Day 30, 90 and 240|All 36 participants who received study treatment were included in this pharmacodynamic analysis. n=number of participants with measurable AB at the specified time point.|||picograms (pg)/milliliter (mL)||Standard Deviation|Mean
2633769|NCT01821118|Secondary|Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Time to Return to Baseline From Visual Task-evoked fMRI|BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. All values are presented in log e scale.|Baseline, Day 2, Day 90|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at the specified day.|||seconds||90% Confidence Interval|Least Squares Mean
2633770|NCT01821118|Secondary|Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Amplitude From Visual Task-evoked fMRI|BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. All values are presented in log e scale.|Baseline, Day 2, Day 90|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at the specified day.|||percent||90% Confidence Interval|Least Squares Mean
2633782|NCT01820637|Other Pre-specified|Percentage of Participants With Composite of Major Adverse Events|The composite rate of Major Adverse Events (MAEs) is defined as all causes of death through 1 month, target limb major amputation through 9 months and/or target lesion revascularization through 9 months.|9 months|55 subjects were included in this analysis - one subject withdrew consent at the 1 month follow-up visit and one subject did not complete the 9 month follow up visit due to site relocation.|||percentage of participants||95% Confidence Interval|Number
2633771|NCT01821118|Secondary|Change From Baseline to Day 2 and Day 90 in Cerebrovascular Reactivity as Measured by the Time to Peak From Visual Task-evoked fMRI|BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and SEs are presented in log e scale.|Baseline, Day 2, Day 90|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at the specified day.|||seconds||Standard Error|Geometric Mean
2633772|NCT01821118|Primary|Change From Baseline to Day 90 in Cerebrovascular Reactivity as Measured by the Slope (Amplitude Over Time to Peak) From Visual Task-evoked fMRI|BOLD fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using ASL scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and SEs are presented in log e scale.|Baseline, Day 90|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified ROI at Day 90.|||percent/second||Standard Error|Geometric Mean
2633773|NCT01821118|Primary|Change From Baseline to Day 2 in Cerebrovascular Reactivity as Measured by the Slope (Amplitude Over Time to Peak) From Visual Task-evoked Functional Magnetic Resonance Imaging (fMRI)|Blood Oxygen Level Dependant (BOLD) fMRI was performed at Screening (Baseline) and on Days 2 and 90. During each of these sessions, BOLD fMRI images were acquired in rapid succession as a flashing radial black and white checkerboard was presented alternately with a gray screen. This well established visual stimulus is known to produce a reliable increase in BOLD fMRI signal within the visual cortex region of the occipital lobe. The time course of the BOLD fMRI signal was used to assess the vascular reactivity. Imaging sites also acquired cerebral blood flow data using Arterial Spin Labeled (ASL) scans at Screening and on Days 2 and 90. A standard T1-weighted image was also acquired to aid image analysis. All efficacy scans were analyzed centrally. Geometric means are presented in the original scale and standard errors (SE) are presented in logarithmic (log e) scale.|Baseline, Day 2|The full analysis set (FAS) consisted of all participants who received at least 1 post-dose efficacy measurement. n=number of evaluable participants for the specified region of interest (ROI) at Day 2.|||percent/second||Standard Error|Geometric Mean
2633774|NCT01821105|Secondary|Tumor Detection||At surgery||||lesions detected|||Number
2633775|NCT01821105|Secondary|All Adverse Events and Complications||up to 12 months||||patients|||Number
2633776|NCT01821105|Primary|Detection of Position Accuracy With Handheld Probe on Anatomical Location.||up to 12 months|number of tumor lesions detected by the probe|||lesions|Participants||Number
2633777|NCT01820754|Secondary|Patterns of Pathologic Response and Response Evaluation Criteria in Solid Tumor (RECIST) Response|"Within each category of RECIST response [partial response (PR), stable disease (SD), progressive disease (PD)], the number of subjects experiencing a pathologic complete response, pathologic partial response, and no pathologic response. RECIST evaluation will be conducted after completion of neoadjuvant therapy. Pathologic response will be evaluated in the resected tumor as follows:~No Pathologic Response: No evidence of cell death or tumor necrosis~Pathologic Partial Response: ≥30% tumor necrosis or cell death~Pathologic Complete Response: No evidence of viable tumor in surgical specimen (includes lung tissue and dissected lymph nodes)"|3 months|Note: pathological response was not captured for study participants. Therefore, the RECIST responses for patients at neoadjuvant month 3 are reported.|||Participants|||Count of Participants
2633778|NCT01820754|Secondary|Number of Subjects Experiencing a Metastasis by Site of Metastasis|Number of patients experiencing a metastasis between baseline and cycle 3|3 months|Intent to treat|||Participants|||Count of Participants
2633779|NCT01820754|Secondary|Median Disease-Free Survival|Disease-free survival (DFS) is defined as the time from surgical resection to disease recurrence (first disease recurrence or death, whichever comes first) after surgery. Patients alive who had not recurred as of the last follow-up had DFS censored at the last follow-up date. The Kaplan-Meier estimator will be used to estimate median DFS and its 95% confidence interval.|5 years|Patients were no longer followed for recurrence following surgery, so this outcome was not captured||||||
2633780|NCT01820754|Secondary|Feasibility and Tolerability of Neoadjuvant Chemotherapy Plus Ipilimumab and Surgery|"Number of subjects experiencing any of the criteria listed below:~Number of subjects receiving 3 doses of preoperative therapy~Number of subjects undergoing surgical exploration within 42 days of day 1 of the last cycle of neoadjuvant chemotherapy~Number of subjects undergoing lobectomy having surgery-related mortality~Number of subjects experiencing dose-limiting toxicity (DLT) during neoadjuvant therapy. DLT will be defined as treatment-related: ≥ Grade 4 hematologic toxicity (excluding neutropenia without fever or infection) or ≥ Grade 3 non-hematologic toxicity (excluding fatigue, nausea, vomiting, peripheral neuropathy, chemotherapy infusion reaction to carboplatin or paclitaxel)"|6 months|Intent to treat|||Participants|||Count of Participants
2633781|NCT01820754|Primary|Percentage of Subjects With Detectable Circulating T Cells After Treatment|"The primary objective of this trial is to determine the percentage of early stage lung cancer patients with detectable circulating T cells specific against tumor-associated antigen (TAA) after receiving platinum based neoadjuvant chemotherapy plus ipilimumab before surgery. Based on Duke intracellular cytokine staining (ICS) assessments over the past 8 years, detectable circulating T cells with specificity against TAA are defined as a CD8, CD4, and double positive (DP) (CD4+CD8+) lymphocyte percentage of ≥ 0.05% with each value also being at least twice that of the background unstimulated control value."|3 months|Intent to treat. Note that the 16.7% of patients that had detectable T-cell responses also had responses at baseline|||Percentage of participants|||Number
2633783|NCT01820637|Primary|Primary Patency|Primary patency of target lesion at 9-months assessed by duplex ultrasound (DUS) as adjudicated by an independent core laboratory. Primary Patency: percentage (%) of lesions (target stented segments) that reach endpoint without a hemodynamically significant stenosis on DUS and without target lesion revascularization (TLR) or, bypass of the target lesion.|9-months|54 subjects were included in this analysis - one 9 month visit was completed too early, outside the protocol defined visit window, one subject withdrew consent at the 1 month follow-up visit and one subject did not complete the 9 month follow up visit due to site relocation.|||percentage of lesions|Lesions|90% Confidence Interval|Number
2633784|NCT01820585|Primary|Absolute Change From Baseline to Endpoint in Mean Pain|The primary efficacy variable was the absolute change from baseline to endpoint in mean pain. Pain intensity was assessed on an 11-point (0-10) Numeric pain rating scale (NPRS), where 0 = no pain and 10 = worst possible pain and was recorded in a subject's diary. The subject was instructed to complete the assessment daily on awakening.Primary analyses were conducted on the full analysis set (FAS) which consisted of all randomised subjects who received at least 1 dose of study medication and with at least 1 post-randomisation rating of 24-h-average pain. The primary efficacy variable was the absolute change from baseline to endpoint in mean pain recorded in a subject's diary upon awakening each morning. An ANCOVA on the FAS revealed no statistically significant differences between the 3 ESL groups and the placebo group after 13 weeks of treatment.|Baseline and 13 Weeks||||units on a scale||Standard Error|Least Squares Mean
2633785|NCT01820559|Primary|Absolute Change From Baseline in the Frequency of Migraine Attacks|The primary efficacy variable was the absolute change from baseline in the frequency of migraine attacks standardised to 4 weeks in the Maintenance Period, as recorded in the subject diary. If there were less than 24 h between the end of 1 migraine event and the start of the next event, these 2 events were considered to belong to 1 migraine attack. There had to be a minimum of 24 h of freedom from headache, pain, and symptoms of migraine between attacks recorded in the subject diary to be considered as more than 1 attack of migraine for statistical analysis.|4 weeks||||number of migraine attacks/participant||Standard Error|Least Squares Mean
2633786|NCT01820416|Primary|Change in Speech Perception|Hearing status, as assessed by the Connected Sentence Test (CST). Difference scores (post-test - pretest) are reported. The CST approximates everyday conversation. Scoring is based on the number of correctly repeated key words. Higher numbers indicate better scores. The minimum score is 0 (0%) and the maximum is 100 (100%). When comparing test-retest scores for an individual, Cox et al. (1988) suggest that changes of 15% or more (based on 100 key words) are indicative of significant changes. We subtracted the post-test from the pre-test, so that negative difference scores indicate worse performance, and positive difference scores indicate better performance. Difference scores with an absolute value smaller than 15 are interpreted as no significant change. In addition, pre- and post-test performance was assessed for groups using t-tests on the difference scores.|7-10 days after baseline measures recorded||||difference scores||Standard Deviation|Mean
2633787|NCT01820364|Secondary|Molecular Status of Markers Relevant to the RAP/MEK/ERK and PI3K/AKT Pathways|Molecular status was not evaluated due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study.|Baseline and at progression with LGX818 single agent treatment|||||||
2633788|NCT01820364|Secondary|Tumor Response (Overall Response Rate) Via Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part II)|"Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment.~The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment.~Per RECIST guidelines:~Complete Response (CR) is the Disappearance of all target lesions.~Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions.~Progressive Disease (PD) is the at least a 20% increase in the sum of diameters of target lesions.~Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.~One patient with documented PD at study Day 146 entered into Part II of the study and received combination treatment of LGX818 450 mg plus MEK162 45 mg for two weeks. The patient experienced disease progression on Day 22 of Part II and discontinued the study."|Entry to Part II of the study through study completion (approximately 22 days)|This analysis group is comprised of the Full Analysis Set, which consists of all patients who received at least one dose of LGX818.|||participants|||Number
2633789|NCT01820364|Secondary|Tumor Response (Overall Response Rate) Via Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part I)|"Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment.~The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment.~Per RECIST guidelines:~Complete Response (CR) is the Disappearance of all target lesions.~Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions.~Progressive Disease (PD) is the at least a 20% increase in the sum of diameters of target lesions.~Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD."|Baseline through completion of Part I of the study (approximately 2 years)|This analysis is comprised of the Full Analysis Set, which consists of all patients who received at least one dose of LGX818.|||participants|||Number
2633790|NCT01820364|Secondary|Plasma Concentration and Derived Pharmacokinetic Parameters|Assessment of pharmacokinetic (PK) parameters and plasma concentration was not done due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study.|Baseline through study completion (approximately 2 years)|||||||
2633791|NCT01820364|Secondary|Incidence of Dose Limiting Toxicities (DLTs) (Part II)|Incidence of DLTs in Part II of the study was not evaluated due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study.|Baseline through study completion (approximately 2 years)|||||||
2633804|NCT01819922|Secondary|Change From Baseline in Early and Late Peak Velocity|Tissue velocities were measured off-line from 2D color-coded tissue doppler images and reported as the average of 3 consecutive cardiac cycles. Tissue Doppler Imaging measured the velocity of the heart muscle or myocardium through the phases of one or more heartbeats by the Doppler effect (frequency shift) of the reflected ultrasound. Change from baseline in early and late peak tissue velocities were reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."|||cm/sec||Standard Deviation|Mean
2633792|NCT01820364|Primary|Tumor Response (Overall Response Rate) Per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part I & Part II)|"Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment.~The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment.~Per RECIST guidelines:~Complete Response (CR) is the Disappearance of all target lesions.~Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions.~Progressive Disease (PD) is the at least a 20% increase in the sum of diameters of target lesions.~Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD."|Baseline through study completion (approximately 2 years)|This analysis is comprised of the Full Analysis Set, which consists of all patients who received at least one dose of LGX818.|||participants|||Number
2633793|NCT01819935|Secondary|Clinical Success|Clinical success, a composite outcome defined as discharge from the hospital or ICU by day 14 after treatment initiation, in the absence of death, therapy change, or intubation by day 14. Percentage of participants with clinical success was reported.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|"FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia. Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||percentage of participants|||Number
2633794|NCT01819935|Secondary|Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection|Time to MRSA re-infection was defined as readmission with MRSA infection to any veterans affairs hospital facility within 30 days after hospital discharge.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.|||days||Full Range|Median
2633795|NCT01819935|Secondary|Time to 30-day Re-admission|Time to readmission to any veterans affairs hospital facility within 30 days after hospital discharge was reported.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.|||days||Full Range|Median
2633796|NCT01819935|Secondary|Time to Intubation|Time to intubation was calculated from the initiation of therapy (index date) to intubation (event date).|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.|||days||Full Range|Median
2633797|NCT01819935|Secondary|Time to Transfer Out From the Intensive Care Unit (ICU)|Time to discharge from the ICU was calculated from the initiation of therapy (index date) to the time the participant was transferred out from ICU (event date). Transfer out of an ICU was assessed among those participants who had initiated linezolid or vancomycin therapy in the ICU.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.|||days||Full Range|Median
2633798|NCT01819935|Secondary|Time to Discharge From the Hospital|Time to discharge from hospital was calculated from initiation of therapy (index date) to hospital discharge (event date).|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.|||days||Standard Deviation|Mean
2633799|NCT01819935|Secondary|Time to Therapy Change|Time to therapy change was calculated from initiation of therapy (index date) to change in therapy (event date). Therapy change was defined as the discontinuation of linezolid or vancomycin and initiation of a different agent with activity against MRSA (clindamycin, daptomycin, doxycycline, linezolid, minocycline, tigecycline, trimethoprim/sulfamethoxazole, vancomycin). As such, therapy change included switching from linezolid to vancomycin, switching from vancomycin to linezolid, or switching from either linezolid or vancomycin to another anti-MRSA antibiotic.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.|||days||Full Range|Median
2633800|NCT01819935|Primary|Time to 30-day Mortality|Time to death (all-cause mortality) occurring within 30 days of treatment initiation was reported. Mortality was assessed from admission vital status databases.|Baseline (1 January 2001) up to 3559 Days (30 September 2010)|FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.|||days||Full Range|Median
2633801|NCT01819922|Secondary|Plasma Metabolomic Profiles Before and Immediately Following Steady State and Incremental Exercise|Plasma metabolomic profiles before and immediately following steady state and incremental exercise were collected using vacutainer tube containing dipotassium ethylenediamine tetraacetic Acid (K2EDTA) were processed by the clinical site according to handling specifications.|1 hour pre-dose, 1 hour 20 minutes and 2 hours 10 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.||||||
2633802|NCT01819922|Secondary|Peak Diastolic Untwisting Rate|Diastolic untwisting is an important component of early diastolic left ventricular filling. Left ventricular diastolic function is determined by early diastolic relaxation and myocardial stiffness. Peak diastolic untwisting rate is defined as the rate of left ventricular relaxation. It was assessed by echocardiography using speckled tracking analysis.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.||||||
2633803|NCT01819922|Secondary|Diastolic Strain Rate|Diastolic strain rate was defined as the rate of percent change in all segments of left ventricular dimension in comparison to its original dimension. It was assessed by echocardiography using speckled tracking analysis.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.||||||
2635702|NCT01800162|Secondary|Future Fertility|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|6 weeks|||||||
2633805|NCT01819922|Secondary|Early and Late Peak Tissue Velocity|Tissue velocities were measured off-line from two dimensional (2D) color-coded tissue doppler images and reported as the average of 3 consecutive cardiac cycles. Tissue Doppler Imaging measured the velocity of the heart muscle or myocardium through the phases of one or more heartbeats by the Doppler effect (frequency shift) of the reflected ultrasound. Early and late peak tissue velocities (EPV and LPV) were reported.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."|||cm/sec||Standard Deviation|Mean
2633806|NCT01819922|Secondary|Change From Baseline in Trans-mitral Doppler Time|Trans-mitral doppler time was measured as the time between the closure of the aortic valve and the opening of the mitral valve. It was determined on spectral doppler echocardiography. Change from baseline in trans-mitral doppler time was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."|||msec||Standard Deviation|Mean
2633807|NCT01819922|Secondary|Trans-mitral Doppler: Time|Trans-mitral doppler time was measured as the time between the closure of the aortic valve and the opening of the mitral valve. It was determined on spectral doppler echocardiography.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."|||msec||Standard Deviation|Mean
2633808|NCT01819922|Secondary|Change From Baseline in Trans-mitral Doppler Ratio|Trans-mitral doppler ratio was Transmitral E wave peak velocity divided by transmitral A wave peak velocity. The E/A ratio was defined the ratio of the early (E) to late (A) ventricular filling velocities and was marker of the function of the left ventricle of the heart. It was determined on spectral doppler echocardiography. Change from baseline in trans-mitral ration was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."|||ratio||Standard Deviation|Mean
2633809|NCT01819922|Secondary|Trans-mitral Doppler: Ratio|Trans-mitral doppler ratio was Transmitral E wave peak velocity divided by transmitral A wave peak velocity. The E/A ratio was defined the ratio of the early (E) to late (A) ventricular filling velocities and was marker of the function of the left ventricle of the heart. It was determined on spectral doppler echocardiography.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes|"FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement. Here, n specified the number of participants who were evaluable for the specified time-point."|||ratio||Standard Deviation|Mean
2633810|NCT01819922|Secondary|Change From Baseline in Systolic Global Strain Rate|Global longitudinal left ventricular strain rate was defined as the rate of percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global strain rate was assessed by echocardiography using speckled tracking analysis. Change from baseline in systolic global strain rate was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||percent change per second||Standard Deviation|Mean
2633811|NCT01819922|Secondary|Systolic Function: Global Strain Rate|Global longitudinal left ventricular strain rate was defined as the rate of percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global strain rate was assessed by echocardiography using speckled tracking analysis.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||percent change per second||Standard Deviation|Mean
2633812|NCT01819922|Secondary|Systolic Function: Rotation/Torsion|Torsion is the twisting of an object due to an applied torque. It is expressed in newton metres. The left ventricle twists in systole storing potential energy and untwists (recoils) in diastole releasing the energy. Twist aids left ventricular ejection and untwist aids relaxation and ventricular filling. Therefore, rotation and torsion are important in cardiac mechanics. It was assessed by echocardiography using speckled tracking analysis .|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.||||||
2633813|NCT01819922|Secondary|Change From Baseline in Peak Contractile Velocity|It was assessed by echocardiography using Tissue Doppler Imaging (Color Post-Processing). Change from baseline in peak contractile velocity was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||cm/sec||Standard Deviation|Mean
2633814|NCT01819922|Secondary|Systolic Function: Peak Contractile Velocity|It was assessed by echocardiography using Tissue Doppler Imaging (Color Post-Processing).|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||centimeter per second (cm/sec)||Standard Deviation|Mean
2633815|NCT01819922|Secondary|Change From Baseline in Ejection Fraction|Systolic ejection fraction was the fraction of the end-diastolic volume that was ejected out of left ventricle with each contraction, estimated by echocardiography. EDV was the volume of blood within a ventricle immediately before a contraction. Ejection fraction served as a general measure of the cardiac function of a participant. Change from baseline in ejection fraction was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||percentage of EDV||Standard Deviation|Mean
2633816|NCT01819922|Secondary|Systolic Function: Ejection Fraction|Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction, estimated by echocardiography. EDV was the volume of blood within a ventricle immediately before a contraction. Ejection fraction served as a general measure of the cardiac function of a participant.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||percentage of EDV||Standard Deviation|Mean
2633817|NCT01819922|Secondary|Change From Baseline in Atrial Volumes|Atrial volumes were assessed by echocardiography using 2-dimensional gray-scale imaging and were calculated using the bi-plane area-length method. Both end-systole volumes and end-diastole volumes were reported. Change from baseline in atrial volume was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mL||Standard Deviation|Mean
2633818|NCT01819922|Secondary|Cardiac Structure: Atrial Volume|Atrial volumes were assessed by echocardiography using 2-dimensional gray-scale imaging and were calculated using the bi-plane area-length method. Both end-systole volumes (ESV) and end-diastole volumes (EDV) were reported.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mL||Standard Deviation|Mean
2633819|NCT01819922|Secondary|Change From Baseline in Right Ventricular Dimension|Right ventricle is the chamber in the heart responsible for pumping blood to the lungs. Right ventricular dimensions included end-diastole area and end-systole area. It was assessed by echocardiography using 2-dimensional gray-scale imaging. Change from baseline in right ventricular dimension was reported.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mm||Standard Deviation|Mean
2633820|NCT01819922|Secondary|Cardiac Structure: Right Ventricular Dimension|Right ventricle is the chamber in the heart responsible for pumping blood to the lungs. Right ventricular dimensions included end-diastole area (EDA) and end-systole area (ESA). It was assessed by echocardiography using 2-dimensional gray-scale imaging.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||millimetre (mm)||Standard Deviation|Mean
2633821|NCT01819922|Secondary|Cardiac Structure: Left Ventricular Geometry|Left ventricular geometry was assessed by echocardiography using 2-dimensional gray-scale imaging. Relative wall thickness was the index of left ventricular geometry and defined as the sum of interventricular septal thickness (mm) and posterior wall thickness (mm) divided by LV internal end-diastolic diameter (mm).|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.||||||
2633822|NCT01819922|Secondary|Cardiac Structure: Left Ventricular Wall Thickness|Left ventricle is the chamber in the heart responsible for pumping blood to the rest of the body. Thickening of the lower chambers of left ventricular wall is also termed as ventricular hypertrophy. It was assessed by echocardiography using 2-dimensional gray-scale imaging; M-mode.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.||||||
2633823|NCT01819922|Secondary|Change From Baseline in the Left Ventricular Volume|Left ventricular volume was defined as volume of blood pumped from the left ventricle to the heart per beat. It was calculated using measurements of ventricle volumes from an echocardiogram and subtracting the volume of the blood in the ventricle at the end of a beat (called end-systolic volume) from the volume of blood just prior to the beat (called end-diastolic volume). Change from baseline in left ventricular volume was reported using modified Simpson's technique.|1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mL||Standard Deviation|Mean
2633824|NCT01819922|Secondary|Cardiac Structure: Left Ventricular Volume|Left ventricular volume was defined as volume of blood pumped from the left ventricle to the heart per beat. It was calculated using measurements of ventricle volumes from an echocardiogram and subtracting the volume of the blood in the ventricle at the end of a beat (called end-systolic volume) from the volume of blood just prior to the beat (called end-diastolic volume). Left ventricular volume was reported using modified Simpson's technique.|20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mL||Standard Deviation|Mean
2633825|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Physical Work Capacity at a Heart Rate of 130 Beats Per Minute (PWC 130)|Physical work capacity evaluates the capacity of an individual to perform physically demanding work tasks. PWC 130 was a simple sub-max exercise parameter that can be used as surrogate for fitness that was independent of metabolic cart measurements. Interventions that improve fitness improve the PWC 130.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||bpm||Standard Deviation|Mean
2633826|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Aerobic Efficiency|Aerobic efficiency was defined as volume of oxygen divided by work. This parameter was assessed during cardiovascular exercise test.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mL/watt||Standard Deviation|Mean
2633856|NCT01819597|Secondary|Asymptomatic Cerebral Hemorrhage|Asymptomatic cerebral hemorrhage, defined as parenchymal or intraventricular bleeding detected in any imaging modality that is not associated with neurological deficits.|1 year||||Participants|||Count of Participants
2633827|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Oxygen (O2) Kinetics|Oxygen kinetics describes the dependence of respiration of isolated cells on oxygen partial pressure. The characteristics of oxygen uptake kinetics differ with intensity of exercise.|1 hour 40 minutes post-dose|Data was not collected for this outcome measure as per study team’s decision since single dose was not considered to be sufficient to analyze this specific parameter.||||||
2633828|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Oxygen (O2) Pulse|Oxygen Pulse (VO2 /Heart Rate) was equal to stroke volume multiplied by oxygen extraction. This parameter was assessed during cardiopulmonary exercise test.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mL/beat||Standard Deviation|Mean
2633829|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Volume of Oxygen (VO2) at Anaerobic Threshold (AT)|VO2 at anaerobic threshold was widely recognized as a sub-max indicator of fitness. The parameter was assessed during indirect calorimetry.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mL||Standard Deviation|Mean
2633830|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)|VE/VCO2 slope was also termed as ventilator efficiency. It was defined as the amount of minute ventilation required to eliminate 1 liter of carbon dioxide. The determinants of VE/VCO2 included fractional dead space and partial pressure of carbon dioxide. The parameter was assessed during indirect calorimetry.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||unitless||Standard Deviation|Mean
2633831|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Respiratory Exchange Ratio (RER)|RER was defined as the ratio between the amount of oxygen (O2) consumed and carbon dioxide (CO2) produced in one breath. The parameter was assessed during indirect measure of heat production (calorimetry).|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||ratio||Standard Deviation|Mean
2633832|NCT01819922|Secondary|Cardiopulmonary Exercise Test: Peak Volume of Oxygen (VO2)|VO2 was the maximum rate of oxygen consumption as measured during incremental or prolonged, sub-maximal exercise. It reflects the aerobic physical fitness of the individual. It was assessed during indirect measure of heat production (calorimetry). The unit of measure is milliliter per kilogram per minute (mL/kg/min).|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mL/kg/min||Standard Deviation|Mean
2633833|NCT01819922|Secondary|Number of Participants With Categorical Post-dose Cardiovascular Monitoring Data: Electrocardiogram (ECG) Parameters|Criteria for clinically significant ECG values included: maximum PR interval >=300 millisecond (msec) and maximum increase of >=25 percent (%) from baseline value of >200 msec and >=50 % for baseline value of <=200 msec, maximum QRS interval >=140 msec or maximum increase of >=50% for baseline value of >100 msec; QT interval corrected using the Fridericia formula (QTcF) 450-<480 msec, 480-<500, >=500 msec or increase of >45 msec or maximum increase of >=30 to <60 and >=60 msec for QT interval where, PR interval: interval between the start of the P wave and the start of the QRS complex corresponding to the time between the onset of atrial depolarization and onset of ventricular depolarization; QRS interval: time from electrocardiogram Q wave to the end of the T wave corresponding to ventricle depolarization, QTcF interval: time corresponding to the beginning of depolarization to repolarization of the ventricles.|Baseline up-to 3 hour post-dose|Safety analysis set was defined as all participants who performed the peak aerobic capacity test, were randomized and who had received at least 1 dose of randomized treatment.|||participants|||Number
2633834|NCT01819922|Secondary|Number of Participants With Categorical Post-dose Cardiovascular Monitoring Data|Participants who met the pre-defined criteria for clinically significant cardiovascular events were reported. Criteria for clinically significant cardiovascular events: Blood pressure (BP) [supine systolic and sitting systolic BP (SBP): <90 millimeter of mercury (mm Hg), >=30 mmHg maximum increase and decrease from baseline in same posture; supine diastolic and sitting diastolic BP (DBP): <50 mm Hg, >=20 mmHg maximum increase and >=30 mmHg maximum decrease from baseline in same posture]; pulse rate: supine and sitting: <40 or >120 bpm.|Baseline up-to 3 hours post-dose|"Safety analysis set was defined as all participants who performed the peak aerobic capacity test, were randomized and who had received at least 1 dose of randomized treatment. Here, n specified the number of participants who were evaluable for the specified criteria."|||participants|||Number
2633835|NCT01819922|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities|Criteria for clinically significant:Hematology (hemoglobin,hematocrit,red blood corpuscles [RBC] count:less than [<]0.8*lower limit of normal [LLN];platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN];white blood corpuscles [WBC]:<0.6*LLN or >1.5*ULN;lymphocytes, total neutrophils:<0.8*LLN or >1.2*ULN;basophils,eosinophil, monocytes:>1.2*ULN);Liver Function(aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase:>0.3*ULN;total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin:>1.5*ULN);Renal Function (blood urea nitrogen,creatinine:>1.3*ULN; uric acid:>1.2*ULN);Electrolytes (sodium:<0.95*LLN or >1.05*ULN,potassium,chloride, calcium,bicarbonate:<0.9*LLN or >1.1*ULN; glucose fasting:<0.6*LLN or >1.5*ULN);Urinalysis (urine pH:>1.5*ULN or >4.5;urine glucose,ketones,proteins, nitrites, leukocyte esterase,blood/hemoglobin:greater than or equal to (>=)1;urine WBC and RBC,urine bacteria:>=20/High Power Field [HPF];epithelial cells:>=6/HPF).|Baseline up-to 3 hours post-dose|Safety analysis set was defined as all participants who performed the peak aerobic capacity test, were randomized and who had received at least 1 dose of randomized treatment.|||participants|||Number
2633872|NCT01819311|Secondary|Screen for Child Anxiety Related Emotional Disorders - Parent Version|The Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P) assesses anxiety symptom severity in youth ages 6-17 years. The parent rates youth anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.|post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)||||units on a scale||Standard Deviation|Mean
2633836|NCT01819922|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. Treatment-emergent were events between first dose of study drug and up to 5-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. Adverse events included both serious and non-serious adverse events.|Baseline up to 5-10 days after last dose of study drug (up to 25 days)|Safety analysis set was defined as all participants who performed the peak aerobic capacity test, were randomized and who had received at least 1 dose of randomized treatment.|||participants|||Number
2633837|NCT01819922|Primary|Cardiopulmonary Exercise Test: Oxygen Uptake Efficiency Slope (OUES): 1 Hour 40 Minute Post-dose|OUES was defined as an index of cardiopulmonary functional reserve that was based upon a submaximal exercise effort. OUES relates oxygen uptake to total ventilation during exercise.|1 hour 40 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||mL/log10(L)||Standard Deviation|Mean
2633838|NCT01819922|Primary|Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 2 Hours 5 Minutes Post-dose|Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.|2 hours 5 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||percent change||Standard Deviation|Mean
2633839|NCT01819922|Primary|Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 1 Hour 30 Minutes Post-dose|Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.|1 hour 30 minutes post-dose|FAS was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 PD measurement.|||percent change||Standard Deviation|Mean
2633840|NCT01819922|Primary|Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 20 Minutes Pre-dose|Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.|20 minutes pre-dose|Full analysis set (FAS) was defined as all participants who performed the peak aerobic capacity test, were randomized and received at least 1 dose of randomized treatment, and had at least 1 pharmacodynamic (PD) measurement.|||percent change||Standard Deviation|Mean
2633841|NCT01819883|Primary|Change in Thigh Muscle Cross-sectional Area|Change in thigh muscle cross-sectional area after biochemical control of acromegaly|Baseline and 3-month follow-up visit|20 subjects with active acromegaly completed a baseline visit. 16 subjects completed a follow-up visit after biochemical control of acromegaly had been achieved.|||Cm^2||Standard Deviation|Mean
2633842|NCT01819883|Primary|Change in Liver Fat|Change in intrahepatic fat after biochemical control of acromegaly|Baseline and 3-month follow-up visit|20 subjects with active acromegaly completed the baseline visit. 16 subjects completed the follow-up visit after biochemical control of acromegaly.|||Lipid/water ratio||Inter-Quartile Range|Median
2633843|NCT01819844|Secondary|Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard.|The Mean Absolute Relative Difference (MARD) between CGM and Glucoscout|12 hours||||percent absolute relative difference||Standard Deviation|Mean
2633844|NCT01819844|Secondary|Dextrose Dosing (g/kg)||12 hours||||grams/kilogram||Standard Deviation|Mean
2633845|NCT01819844|Secondary|Insulin Dosing (u/kg)||12 hours||||units/kilogram||Standard Deviation|Mean
2633846|NCT01819844|Secondary|Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl||12 hours||||percentage of time||Standard Deviation|Mean
2633847|NCT01819844|Secondary|Number of BG Events < 70 mg/dl as Determined by the CGM||12 hours||||events|||Number
2633848|NCT01819844|Secondary|Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm||12 hours||||mg/dl||Standard Deviation|Mean
2633849|NCT01819844|Secondary|Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl||12 hours||||percentage of time||Standard Deviation|Mean
2633850|NCT01819844|Secondary|Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements||12 hours||||Blood glucose values < 70 mg/dl|||Number
2633851|NCT01819844|Secondary|Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol||12 hours||||number of carbohydrate interventions|||Number
2633852|NCT01819844|Primary|Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements.||12 hours||||mg/dl||Standard Deviation|Mean
2633853|NCT01819727|Other Pre-specified|Dietary Phenylalanine|All patients will complete a 3-day diet diary in order to assess dietary phenylalanine intake.|baseline and 36 weeks|The intent-to-treat (ITT) population will consist of all subjects who are randomized to study treatment whether or not treatment was received.|||mg||Standard Deviation|Mean
2633854|NCT01819727|Secondary|Blood Phenylalanine Concentration|Plasma phenylalanine (Phe) concentration|baseline and 36 weeks|The intent-to-treat (ITT) population will consist of all subjects who are randomized to study treatment whether or not treatment was received.|||umol/L||Standard Deviation|Mean
2633855|NCT01819727|Primary|Number of Participants With Hypersensitivity Adverse Reaction|"Hypersensitivity AEs will be identified in two ways:~Broad Algorithmic anaphylactic reaction Standardized MedDRA Queries (SMQ)~Modified Hypersensitivity SMQ to include above additional preferred terms"|baseline and 36 weeks|The safety population will consist of all subjects who receive any pegvaliase throughout the study duration. The safety population will be analyzed according to the treatment assignment actually received.|||Participants|||Count of Participants
2633857|NCT01819597|Secondary|Improved Collaterals|"Number of participants with an increase by at least one grade on the American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) Collateral Flow Grading System~The ASITN/SIR Collateral Flow Grading System has 4 grades:~0=no collaterals visible to the ischemic site.~slow collaterals to the periphery of the ischemic site with persistence of some of the defect~rapid collaterals to periphery of ischemic site with persistence of some of the defect and to only a portion of the ischemic territory~collaterals with slow but complete angiographic blood flow of the ischemic bed by the late venous phase~complete and rapid collateral blood flow to the vascular bed in the entire ischemic territory by retrograde perfusion.~Grade 4 represents the best outcome. Grade 0 represents the worst outcome."|1 year|Evidence of angiographic neovasculariozation|||Participants|||Count of Participants
2633858|NCT01819597|Secondary|Cognitive Outcome|Mean cognitive outcome at the end of follow-up measured by the Montreal Cognitive Assessment (MoCA). Scores on the MoCA scale range between 0 and 30. Higher values represent a better outcome. A normal score on the MoCA scale is 26 or higher.|2 years|Montreal Cognitive Outcome Assessment (MoCA)|||MoCA Score||Standard Deviation|Mean
2633859|NCT01819597|Secondary|Functional Outcome|"Proportion of participants with good functional outcome at the end of follow-up measured by the modified Rankin scale (mRS). That is with mRS scores between 0 and 2.~Modified Rankin Scale~Score and Description:~0 - No symptoms at all~- No significant disability despite symptoms; able to carry out all usual duties and activities~- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance~- Moderate disability; requiring some help, but able to walk without assistance~- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance~- Severe disability; bedridden, incontinent and requiring constant nursing care and attention~- Dead"|2 years|Good functional outcome (Modified Rankin Scores 0-2)|||Participants|||Count of Participants
2633860|NCT01819597|Secondary|Major Non-stroke Hemorrhage|Number of participants with systemic hemorrhage, subdural or epidural hemorrhages|2 years||||Participants|||Count of Participants
2633861|NCT01819597|Secondary|Myocardial Infarction|Number of participants with heart attack within 30 days of surgery|30 days||||Participants|||Count of Participants
2633862|NCT01819597|Primary|Stroke or Death in the Territory of Qualifying Artery|"The primary study endpoint is the number of participants with any stroke or death within 30 days after enrollment, or any ischemic stroke or death attributable to ischemia in the territory of the qualifying artery at one year.~Ischemic stroke is defined as a new focal neurological deficit of sudden onset, lasting at least 24 hours and not associated with CT or MRI findings of hemorrhage."|1 year||||Participants|||Count of Participants
2633863|NCT01819506|Secondary|Surface Electromyographic (sEMG) Analysis of Functional Arm Muscle Activations|sEMG analysis is an objective method to study muscle coordination during functional arm movements. Subjects will be fitted with sensors on the skin placed over 8 arm/shoulder muscles on both arms. The sensors will detect the muscle activity of these muscles during functional reaching movements. sEMG data will be recorded with a 16-channel wireless Motion Labs EMG system and processed with custom ORBIS software.|participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.|Complete and accurate data for this measure is no longer available.||||||
2633864|NCT01819506|Primary|Wolf Motor Function Test|The Wolf Motor Function Test is an assessment of arm movement function. Subjects are timed (seconds) as they complete 15 functional movements with the paretic arm. The average time required to complete an item is reported in seconds so that lower scores (quicker completion times) indicate greater functional movement skills. Post-intervention averages were compared to baseline averages so a reduction in timed averages indicates improved movement function.|participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.||||seconds||Standard Deviation|Mean
2633865|NCT01819506|Primary|Fugl-Meyer Assessment of the Upper Extremity|The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) is a stroke rehabilitation assessment of arm/hand movement impairment. It is traditionally scored by assigning 30 items assessing voluntary arm/hand movements and 3 items assessing reflexes an ordinal rating (0=unable, 1=partial, 2=near normal), then summing the ratings to obtain a general statement of ability. Instead of this traditional scoring method, the investigators will eliminate the reflex items, thus reporting the aggregate score possible from 0/60 to 60/60 points. Higher scores indicate greater levels of arm movement ability.|participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.||||score on a scale||Standard Deviation|Mean
2633866|NCT01819415|Secondary|Central Foveal Thickness|Measured with spectral-domain optical coherence tomography.|During at least 12 months of follow-up after vitreous biopsy.|||||||
2633867|NCT01819415|Primary|Lipidomics Profile||1 day (At the time of vitreous biopsy)|||||||
2633868|NCT01819415|Primary|Vitreal VEGF Levels.||1 day (At the time of vitreous biopsy)||||pg/ml|||Number
2633869|NCT01819311|Secondary|Screen for Child Anxiety Related Emotional Disorders - Child Version|The Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C) assesses anxiety symptom severity in youth ages 6-17 years. The child rates his or her anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.|8-week follow-up||||units on a scale||Standard Deviation|Mean
2633870|NCT01819311|Secondary|Screen for Child Anxiety Related Emotional Disorders - Parent Version|The Screen for Child Anxiety Related Emotional Disorders - Parent Version (SCARED-P) assesses anxiety symptom severity in youth ages 6-17 years. The parent rates youth anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.|8-week follow-up||||units on a scale||Standard Deviation|Mean
2633871|NCT01819311|Secondary|Screen for Child Anxiety Related Emotional Disorders - Child Version|The Screen for Child Anxiety Related Emotional Disorders - Child Version (SCARED-C) assesses anxiety symptom severity in youth ages 6-17 years. The child rates his or her anxiety symptoms on 41 items; each item is rated from 0 to 2. Total scores range from 0 to 82, with higher scores indicating greater anxiety severity.|post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)||||units on a scale||Standard Deviation|Mean
2634021|NCT01817777|Secondary|Number of Participants Who Missed Metformin Days/Doses for the Indicated Reasons|The number of particiapnts who missed days or doses of metformin was summarized.|Week 28|Per Protocol Population|||Participants|||Number
2633873|NCT01819311|Primary|Clinician Rating on the Pediatric Anxiety Rating Scale|The Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity.|8-week follow-up||||units on a scale||Standard Deviation|Mean
2633874|NCT01819311|Primary|Clinician Rating on the Pediatric Anxiety Rating Scale|The Pediatric Anxiety Rating Scale (PARS) assesses global anxiety severity across social anxiety disorder, separation anxiety disorder, and generalized anxiety disorder in youth ages 6-17 years. An independent evaluator rates anxiety symptoms on 7 dimensions (i.e., number of symptoms, severity of distress, severity of physical symptoms, frequency, avoidance, interference at home, and interference out of home). Each dimension is rated from 0 to 5. Total scores range from 0 to 35, with higher scores indicating greater anxiety severity.|post-treatment (within one week of completing the final of 8 semi-weekly sessions of Attention Bias Modification)||||units on a scale||Standard Deviation|Mean
2633875|NCT01819272|Secondary|Change in HbA1c (%) at 12 Weeks||Baseline and 12 weeks after the first dose of study medication|Week 12 Evaluable|||HbA1c (%)||Standard Error|Least Squares Mean
2633876|NCT01819272|Secondary|AUC4-12wk of Change in Fasting Plasma Glucose (mg/dL*Week) Concentrations From Baseline to 12 Weeks||Baseline and 4 to 12 weeks after the first dose of study medication|Week 12 Evaluable|||mg/dL*week||Full Range|Median
2633877|NCT01819272|Primary|Change in Fasting Plasma Glucose (mg/dL) at 4 Weeks||Baseline and 4 weeks after the first dose of study medication|Week 4 Evaluable|||mg/dL||Full Range|Median
2633878|NCT01819233|Secondary|Overall Survival|Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.|Up to 4 weeks after completion of study|Insufficient data was collected to conduct survival analysis as there were participants who were lost to follow up.|||Participants|||Count of Participants
2633879|NCT01819233|Secondary|Progression Free Survival|Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.|Up to 4 weeks after completion of study||||Participants|||Count of Participants
2633880|NCT01819233|Secondary|Distant Metastases|Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.|Up to 4 weeks after completion of study||||Participants|||Count of Participants
2633881|NCT01819233|Secondary|Local Recurrence|Analyzed via survival methods, specifically the Kaplan-Meier method and the logrank test.|Up to 4 weeks after completion of study||||Participants|||Count of Participants
2633882|NCT01819233|Secondary|Patterns of Change Over Time in Psycho-social Outcomes Measured Using the Functional Assessment of Cancer Therapy-Breast (FACT-B)|Assessed via mixed-effects regression. The FACT-B is a questionnaire using a 5-point Likert scale (0-Not at all to 4-Very much)|Baseline to 4 weeks after completion of study|patients who did not complete all questionnaire timepoints were not included in the analysis|||score on a scale||95% Confidence Interval|Mean
2633883|NCT01819233|Secondary|Patterns of Change Over Time in Serum Markers|Assessed via mixed-effects regression.|Baseline to 4 weeks after completion of study|||||||
2633884|NCT01819233|Secondary|Change in Heart Rate Over Time|Assessed via mixed-effects regression.|Baseline to 4 weeks after completion of study|only participants who completed all timepoints were included|||beats per minute||Standard Error|Mean
2633885|NCT01819233|Secondary|Change in Body Mass Index (BMI)|Assessed via mixed-effects regression. Weight changes over time assessed by modeling BMI as a function of time|Baseline to 4 weeks after completion of study|participants who did not complete all timepoint measurements were not included.|||percentage of change in BMI||95% Confidence Interval|Mean
2633886|NCT01819233|Secondary|Change in Body Fat Measurement|Analyzed via a paired t-test. Change in body fat measurement as determined by the Durnin-Womersley 4-fold technique|Baseline to 4 weeks after completion of study|patients who did not complete all assessments were not included in the analysis|||percentage of change in body fat||95% Confidence Interval|Mean
2633887|NCT01819233|Primary|Number of Participants Who Are Adherent to the Diet Restriction|Computed along with a 95% exact confidence interval. Exact binomial test (with a one-sided alpha of 0.05) will be used to test whether adherence is greater than 60%.|Up to week 12||||participants||95% Confidence Interval|Number
2633888|NCT01819194|Primary|Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale|Meibomian Gland Dysfunction (MGD) as measured using the MGD 0 - 11 scale translated into grades 0 to 3 where 0 refers to absence of markers.|Post 3 days of wear|Subjects analyzed are those who enrolled, randomized, and completed the study per protocol.|||eyes|Eyes||Number
2633889|NCT01819194|Primary|Comfort as Measured by the Contact Lens Users Experience Questionnaire (CLUE)|CLUE is survey that is used to assess subjective comfort of the test article. The higher the score the better on a range of 0 to 120.|Post 3 days of wear|Subjects are those who were enrolled, randomized, and completed the study per protocol.|||units on a scale||Standard Deviation|Mean
2633890|NCT01819129|Secondary|Change From Baseline in Body Weight|For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.|Week 0, week 26|This endpoint was summarized using the FAS. FAS included all randomized subjects.|||Kg||Standard Deviation|Mean
2633891|NCT01819129|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes|A hypoglycaemic episode was defined as treatment-emergent if the onset of the episode was on or after the first day of exposure to randomized treatment and no later than 1 day after the last day of randomized treatment. A severe or blood glucose (BG) confirmed hypoglycaemic episode was an episode that was severe according to the American Diabetes Association (ADA) classification (an episode that required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.|From Week 0 to Week 26.|This endpoint was summarized using the safety analysis set. Safety analysis set included all subjects receiving at least one dose of the test product or comparator. Subjects in the safety analysis set contributed to the evaluation ‘as treated’.|||Number of episodes|||Number
2635703|NCT01800162|Secondary|Acceptability|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|6 weeks|||||||
2633892|NCT01819129|Secondary|Change From Baseline in 2-hour PPG Increment (Meal Test)|For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.|Week 0, week 26|This endpoint was summarized using the Full Analysis Set (FAS). FAS included all randomized subjects.|||mmol/L||Standard Deviation|Mean
2633893|NCT01819129|Primary|Change From Baseline in HbA1c|The primary endpoint was change from baseline in HbA1c after 26 weeks of randomized treatment. For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.|Week 0, Week 26|The analysis of this efficacy endpoint was based on the full analysis set (FAS). FAS included all randomized subjects. The statistical evaluation of the FAS was to follow the intention-to-treat (ITT) principle and subjects contributed to the evaluation ‘as randomized’.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
2633894|NCT01818765|Secondary|Clinical Outcomes|Systemic thrombosis at 2 years|2 years|Those patients who had follow-up available for any time period more than three months were included|||Participants|||Count of Participants
2633895|NCT01818765|Secondary|Biochemical Response: Change in BNP (B-type Natriuretic Peptide) Levels Between Baseline and Six Months|"Change in BNP (b-type natriuretic peptide) levels~BNP levels were measured from a standard blood draw at baseline and six months."|Baseline, 6 months|Those patients who attended follow-up at six months and had both baseline and six month BNP results available were analysed|||pmol/L||Standard Deviation|Mean
2633896|NCT01818765|Secondary|Echocardiographic Response: Change in Ejection Fraction as Measured by Echocardiography From Baseline to 6 Months|Change in echocardiographic parameters of cardiac function ejection fraction was measured using two-dimensional echocardiography and the Simpson method at baseline and six months|Baseline, 6 months|Those patients who attended follow-up at six months and had an echocardiogram with interpretable data were analysed|||% cardiac ejection fraction||Standard Deviation|Mean
2633897|NCT01818765|Secondary|Number of Participants With ≥10% Increase in 6-minute Walk Distance|Change in 6 minute walk distance; ≥10% increase|Baseline, 6 months||||Participants|||Count of Participants
2633898|NCT01818765|Secondary|Number of Participants With >1 Point Improvement in EQ-5D-5L Quality of Life Score|"Change in quality of life as measured using the EQ-5D-5L (EuroQol five dimension, five level score ) tool (>1 point decrease)~The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number from 1 to 5 that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.~Increase in score for each dimension represent worsening of symptoms/ problems"|Baseline, 6 months|Those patients who attended follow-up at six months and completed the questionnaires were analysed|||Participants|||Count of Participants
2633899|NCT01818765|Secondary|NYHA Class|"Improvement in New York Heart Association (NYHA) functional class by >=1 NYHA functional class is a very widely used measure of symptoms in heart failure.~Improvement is considered to be a decrease in class, representing improve symptoms~Class Patient Symptoms I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).~II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).~III Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.~IV Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases."|Baseline, 6 months|Those patients who attended follow-up at six months were analysed|||participants|||Number
2633900|NCT01818765|Secondary|Procedural Success - Number of Participants With Successful Delivery of Left Ventricular Lead Via Ventricular Transseptal Approach|Ability to successfully deliver LV endocardial pacing via the ventricular transseptal approach (procedure success rate)|6 months||||Participants|||Count of Participants
2633901|NCT01818765|Primary|Number of Participants Free of Adverse Effects at 6 Months Post Procedure|"Acute: coronary arterial damage; tamponade or effusion; acute lead displacement; peri-procedural systemic thromboembolism; arrhythmia; bleeding~Chronic: systemic thromboembolism; lead displacement, dysfunction or fracture; system infection; bleeding; arrhythmia; death"|6 months||||Participants|||Count of Participants
2633902|NCT01818752|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs)were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, where GRADE 1 = Mild; GRADE 2 = Moderate; GRADE 3 = Severe; GRADE 4 = Life-threatening; GRADE 5 = Fatal.~A serious adverse event is an adverse event that met 1 or more of the following criteria:~Death~Life-threatening~Required inpatient hospitalization or prolongation of an existing hospitalization~Resulted in persistent or significant disability/incapacity~Congenital anomaly/birth defect~Important medical event that jeopardized the participant and may have required medical or surgical intervention to prevent 1 of the outcomes listed above.~Treatment-related adverse events are adverse events considered related to at least 1 investigational product by the investigator, including those with unknown relationship."|From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.|Safety population|||participants|||Number
2633903|NCT01818752|Secondary|European Organisation for Research and Treatment of Cancer Quality of Life Core Module (EORTC QLQ-C30) Global Health Status/Quality of Life (QOL) Scores|"The EORTC QLQ-C30 is a validated self-rating questionnaire including 30 items used to assess the overall quality of life in cancer patients.~It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).~The EORTC QLQ-C30 Global Health Status/QOL scale was scored between 0 and 100, with higher scores indicating better Global Health Status/QOL."|Baseline, weeks 6, 12, 18, 24, 30, 36, 42 and 48|Intent-to treat population with available data at each time point.|||units on a scale||Standard Deviation|Mean
2635704|NCT01800162|Secondary|Patients' Preferences|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|6 weeks|||||||
2633904|NCT01818752|Secondary|Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy|"Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms.~Peripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03:~Grade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death."|From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.|The safety population included all randomized participants who received at least 1 dose of any study treatment (i.e., carfilzomib, bortezomib, melphalan, or prednisone).|||percentage of participants||95% Confidence Interval|Number
2633905|NCT01818752|Secondary|Complete Response Rate|"Complete response rate was defined as the percentage of participants in each treatment group who achieved a sCR or CR per the IMWG-URC as their best response.~sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).~CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy."|Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.|Intent-to-treat population|||percentage of participants||95% Confidence Interval|Number
2633906|NCT01818752|Secondary|Overall Response Rate|"Disease response was evaluated according to the IMWG-URC using a validated computer algorithm. Overall response was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).~sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).~CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.~PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline."|Disease response was assessed every 3 weeks during the first 54 weeks and every 6 weeks thereafter until PD or the data cut-off date of 15 July 2016; median follow-up time was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.|Intent-to-treat population|||percentage of participants||95% Confidence Interval|Number
2633907|NCT01818752|Secondary|Overall Survival (OS)|"Overall survival (OS) was defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored on the date the patient was last known to be alive.~Median overall survival was estimated using the Kaplan-Meier method."|From randomization until the data cut-off date of 15 July 2016; median follow-up time for OS was 22.2 and 22.5 months in the bortezomib and carfilzomib arms respectively.|Intent-to-treat population|||months||95% Confidence Interval|Median
2633908|NCT01818752|Primary|Progression-Free Survival (PFS)|"Progression-free survival was defined as the time from randomization to the earlier of documented disease progression or death due to any cause. PFS was analyzed using Kaplan-Meier methods. The duration of PFS was censored for participants with no baseline and/or post-baseline disease assessments, who started a new anti-cancer therapy before documentation of disease progression or death, death or disease progression after missed disease assessment of 100 consecutive days or longer, or who were alive without documentation of disease progression before the data cutoff date, including lost to follow-up prior to disease progression.~Participants were evaluated for disease response and progression according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC), determined centrally using a validated computer algorithm in a blinded manner."|From randomization until the data cut-off date of 15 July 2016; median follow-up time for PFS was 21.6.and 22.2 months in the bortezomib and carfilzomib arms respectively.|The intent-to-treat population included all randomized participants.|||months||95% Confidence Interval|Median
2633909|NCT01818726|Primary|Change in Serum Total Iron-binding Capacity (TIBC)|Mean change from baseline in serum total iron-binding capacity was summarized descriptively for all on-treatment study visits.|Screening, Week (Wk) 4, Wk 8, Wk 12, Wk 16, Wk 20, Wk 24, Wk 28, Wk 32, Wk 36, Wk 40, Wk 44, Wk 48, Wk 52|Full Analysis Set (FAS) included all patients of the Safety Analysis Set with the available baseline data, as well as data obtained at follow-up visits and/or the final visit, for evaluation of at least one efficacy parameter.|||μmol/l||Standard Deviation|Mean
2633910|NCT01818726|Primary|Change in Transferrin Saturation With Iron (TSI) Values|Mean percentage change from baseline in transferrin saturation with iron was summarized descriptively for all on-treatment study visits.|Screening, Week (Wk) 4, Wk 8, Wk 12, Wk 16, Wk 20, Wk 24, Wk 28, Wk 32, Wk 36, Wk 40, Wk 44, Wk 48, Wk 52|Full Analysis Set (FAS) included all patients of the Safety Analysis Set with the available baseline data, as well as data obtained at follow-up visits and/or the final visit, for evaluation of at least one efficacy parameter.|||Percentage of saturation||Standard Deviation|Mean
2633911|NCT01818726|Primary|Change in Serum Ferritin Values|"Change from baseline was be summarized descriptively for all on-treatment study visits.~Changes to the planned statistical analysis were related to significant withdrawal of patients from the Per-Protocol Analysis Set due to a large number of patients who discontinued the study (lack of assessments of iron exchange parameters at visits) and deviations from the Protocol affecting the assessment of efficacy parameters. Because of that, the additional efficacy analysis in the Per-Protocol Analysis Set was not performed."|Screening, Week (Wk) 4, Wk 8, Wk 12, Wk 16, Wk 20, Wk 24, Wk 28, Wk 32, Wk 36, Wk 40, Wk 44, Wk 48, Wk 52|Full Analysis Set included all patients of the Safety Analysis Set with available baseline data & data obtained at follow-up visits &/or final visit, for evaluation of at least 1 efficacy parameter. Statistical analysis was not performed due to large number of patients discontinuing & thus lack of assessments of iron exchange parameters at visits.|||ng/ml||Standard Deviation|Mean
2633912|NCT01818700|Secondary|Patients Global Impression og Change(PGIC)|Number of clinician with categorical change in overall status. PGIC: a participant-rated instrument assessing change in patient's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).|8 week|FAS set: 210. Missing values were imputed by LOCF.|||participants|||Number
2633913|NCT01818700|Secondary|Clinician Global Impression of Change(CGIC)|Number of clinician with categorical change in overall status. CGIC: a clinician-rated instrument assessing change in clinician's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).|8weeks|FAS set: 210. Missing values were imputed by LOCF.|||participants|||Number
2633914|NCT01818700|Secondary|Change of EQ-VAS at 8 Weeks of Treatment With Study Drug From Baseline.|EQ-5D Visual Analogue Scale (VAS) in rates the participant's overall health status using values from 0 (worst imaginable) to 100 (best imaginable).|8 week|FAS set: 210. Missing values were imputed by LOCF. Even though 210 subjects were assessed EQ-VAS at visit 1(baseline), 153 Subjects were assessed EQ-VAS at visit 4(8week)|||units on a scale||Standard Deviation|Mean
2633915|NCT01818700|Secondary|Change in Quality of Life at 8 Week of Treatment With Study Drug From Baseline|"The Euroqol Health Survey (EQ-5D, 3-level) was completed on five dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression) to measure health-related quality of life on a scale from 0-1. A higher score indicates better quality of life.~EQ-5D score = 1 - 0.081 - (relevant score by level for the relevant item)-0.269 (only if there is at least one level 3).~Table of scores by level for EQ-5D items mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.236)."|8 weeks|FAS set: 210. Missing values were imputed by LOCF. Even though 210 subjects at Visit 1, baseline were assessed EQ-5D questionnaire, At visit 4(8weeks), 153 subjects were assessed EQ-5D questionnaire.|||units on a scale||Standard Deviation|Mean
2633916|NCT01818700|Secondary|Change of Pain Intensity at 4 Week of Treatment With Study Srug From Baseline.|NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 4/ET minus mean score at Baseline.|4 weeks|FAS set: 210. Missing values were imputed LOCF.|||units on a scale||Standard Deviation|Mean
2633917|NCT01818700|Primary|Change of Pain Intensity* at Week 8 of Treatment With the Study Drug From Baseline|NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain). NRS-Pain scale: Change = mean score at Week 8/ET minus mean score at Baseline.|8 weeks|FAS set: 210. Missing values were imputed by LOCF FAS included the data obtained from all subjects who had at least one dose of the study drug and had data of at least one primary efficacy endpoint assessment.|||units on a scale||Standard Deviation|Mean
2633918|NCT01818596|Secondary|Change From Baseline in eGFR_CKD-EPI,Creatinine at Weeks 48, 96, and 144|eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,creatinine method is adjusted for age, race, and sex.|Baseline; Weeks 48, 96, and 144|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
2633919|NCT01818596|Secondary|Change From Baseline in eGFR_CKD-EPI,cysC at Weeks 48, 96, and 144|eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,cysC method is adjusted for age and sex.|Baseline; Weeks 48, 96, and 144|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
2633920|NCT01818596|Secondary|Change From Baseline in the eGFR_CG at Weeks 48, 96, and 144|eGFR is a measurement of the kidney's ability to filter blood.|Baseline; Weeks 48, 96, and 144|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.|||mL/min||Inter-Quartile Range|Median
2633921|NCT01818596|Secondary|PK Parameter: AUCtau of Tenofovir Diphosphate (TFV-DP) in Peripheral Blood Mononuclear Cell (PBMC) for Participants Enrolled in PK/PD Sub-study|TFV-DP is an active phosphorylated metabolite of tenofovir alafenamide. AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants who were enrolled in the PK/PD substudy, received at least 1 dose of study drug, and for whom the steady-state PK parameter (AUCtau) of TFV-DP was evaluable were analyzed.|||µmol*h/L||Standard Deviation|Mean
2633922|NCT01818596|Secondary|PK Parameter: t1/2 of TAF|t1/2 is defined as the estimate of the terminal elimination half-life of the drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
2633923|NCT01818596|Secondary|PK Parameter: AUCtau of TAF|AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.|||ng*h/mL||Standard Deviation|Mean
2633924|NCT01818596|Secondary|PK Parameter: λz of TAF|λz is defined as the terminal elimination rate constant. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.|||1/hour||Standard Deviation|Mean
2633925|NCT01818596|Secondary|PK Parameter: Tlast of TAF|Tlast is defined as the time of Clast. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
2633926|NCT01818596|Secondary|PK Parameter: Clast of TAF|Clast is defined as the last observable concentration of drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2633927|NCT01818596|Secondary|PK Parameter: Tmax of TAF|Tmax is defined as the time of Cmax. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set with available data were analyzed.|||hours||Inter-Quartile Range|Median
2635705|NCT01800162|Secondary|Time to Resolution|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|6 weeks|||||||
2633928|NCT01818596|Secondary|Pharmacokinetic (PK) Parameter: Cmax of TAF|Cmax is defined as the maximum concentration of drug. Blood draws for this outcome may have been at the Week 2, 4, or 8 visit.|Predose, and 5 minutes, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours postdose|Participants in the PK Substudy Analysis Set (enrolled in the PK/PD substudy, received at least 1 dose of study drug, and for whom steady-state PK parameters were available) with available data were analyzed.|||ng/mL||Standard Deviation|Mean
2633929|NCT01818596|Secondary|Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Weeks 24, 48, 96, and 144|The percentage of participants achieving HIV-1 RNA < 50 Copies/mL at Weeks 24, 48, 96, and 144 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Weeks 24, 48, 96, and 144|Full Analysis Set included participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2633930|NCT01818596|Secondary|Percentage of Participants Experiencing Adverse Events or Graded Laboratory Abnormalities|Adverse events (AEs) and graded laboratory abnormalities occurring during the E/C/F/TAF treatment period were summarized across the participant population. A participant was counted once if they had a qualifying event.|Baseline up to Week 240 plus 30 days|Participants in the Safety Analysis Set were analyzed.|||percentage of participants|||Number
2633931|NCT01818596|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio (μg/g) at Weeks 24, 48, 96, and 144|Urine beta-2-microglobulin is a renal biomarker which is used to evaluate drug-induced kidney injury.|Baseline; Weeks 24, 48, 96, and 144|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.|||percentage change||Inter-Quartile Range|Median
2633932|NCT01818596|Secondary|Percent Change From Baseline in Retinol Binding Protein (RBP) to Creatinine Ratio (μg/g) at Weeks 24, 48, 96, and 144|Urine RBP is a renal biomarker which is used to evaluate drug-induced kidney injury.|Baseline; Weeks 24, 48, 96, and 144|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.|||percentage change||Inter-Quartile Range|Median
2633933|NCT01818596|Secondary|Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) at Weeks 24 and 48|P1NP is a biomarker of bone turnover.|Baseline; Weeks 24 and 48|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.|||percentage change||Inter-Quartile Range|Median
2633934|NCT01818596|Secondary|Percent Change From Baseline in C-type Collagen Sequence (CTX) at Weeks 24 and 48|CTX is a biomarker of bone turnover.|Baseline; Weeks 24 and 48|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.|||percentage change||Inter-Quartile Range|Median
2633935|NCT01818596|Secondary|Change From Baseline in Actual GFR (aGFR) of E/C/F/TAF for Participants Enrolled in the PK/PD Substudy|aGFR was directly measured using iohexol plasma clearance (CLiohexol).|Baseline; Week 2, 4, or 8; Week 24|Participants in the Pharmacodynamic (PD) Substudy Analysis Set (enrolled in the pharmacokinetic (PK)/PD substudy, received at least 1 dose of study drug, and had baseline and at least 1 postbaseline assessment for aGFR assessed by CLiohexol) with available data at the respective time point were analyzed.|||mL/min||Standard Deviation|Mean
2633936|NCT01818596|Primary|Change From Baseline in eGFR Calculated by the CKD-EPI Method Based on Serum Creatinine (eGFR_CKD-EPI,Creatinine) at Week 24|eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,creatinine method is adjusted for age, race, and sex.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
2633937|NCT01818596|Primary|Change From Baseline in eGFR Calculated by the Chronic Kidney Disease Epidemiology Collaboration Method Based on Cystatin C (eGFR_CKD-EPI,cysC) at Week 24|eGFR is a measurement of the kidney's ability to filter blood. The eGFR_CKD-EPI,cysC method is adjusted for age and sex.|Baseline; Week 24|Participants in the Safety Analysis Set with available data at the respective time point were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
2633938|NCT01818596|Primary|Change From Baseline in the Estimated Glomerular Filtration Rate Calculated by the Cockcroft-Gault Formula (eGFR_CG) at Week 24|eGFR is a measurement of the kidney's ability to filter blood.|Baseline; Week 24|Participants in the Safety Analysis Set (enrolled and received at least 1 dose of study drug) with available data at the respective time point were analyzed.|||mL/min||Inter-Quartile Range|Median
2633939|NCT01818531|Secondary|Quadriceps Motor Strength|Comparison of quadriceps motor strength at 6 hour post nerve block between two groups: adductor canal block and lumbar plexus block. The score range is 0-5, with higher scores denoting better outcomes.|6 hours||||units on a scale||Standard Deviation|Mean
2633940|NCT01818531|Secondary|Opioid Related Side Effects|Occurrence of opioid related side effects (nausea, vomiting and pruritus) between two groups: adductor canal block and lumbar plexus block.|6, 12, 18, and 24 hours||||events|||Number
2633941|NCT01818531|Secondary|Time to First Analgesic|Time to first analgesic between two groups: adductor canal block and lumbar plexus block.|24 hours||||minutes||Standard Deviation|Mean
2633942|NCT01818531|Secondary|Opioid Consumption|Comparison of cumulative opioid consumption over 24 hour period between adductor canal block and lumbar plexus block.|6, 12, 18, and 24 hours||||mg||Standard Deviation|Mean
2633943|NCT01818531|Primary|Verbal Pain Scores at 6 Hours Post Nerve Blockade.|Comparison of verbal numerical pain scores at rest and with movement 6 hours following nerve blockade. The score range is 0-10 with higher scores denoting worse outcomes.|6 hours post block.||||score on a scale||Standard Deviation|Mean
2633944|NCT01818518|Primary|Composite Perinatal Morbidity|The primary outcome is Composite Perinatal Morbidity. Composite morbidity refers to the newborns born to the female participants enrolled in the study. Composite Morbidity is defined as ≥ 1 of the following: respiratory distress syndrome (RDS) (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (BPD) (requirement for oxygen support at 28 days of life), severe intraventricular hemorrhage (IVH) (grades III or IV), periventricular leukomalacia (PVL), blood culture-proven sepsis present within 72 hours of birth, necrotising enterocolitis (NEC), or perinatal death (stillbirth or neonatal death prior to hospital discharge).|Infants from birth until discharge or until infant reaches 28 days of life.|Composite morbidity is defined as ≥ 1 of the following: RDS, BPD, severe IVH (grades III or IV), PVL, blood culture-proven sepsis present within 72 hours of birth, NEC, or perinatal death. Perinatal Morbidity assessed pertains to the newborns born to the enrolled female patients.|||participants|||Number
2633945|NCT01818427|Secondary|Acute Lung Injury (ALI) and Transfusion Related Acute Lung Injury (TRALI)|Development of ALI will be assessed which includes: 1) bilateral infiltrates on chest x-ray, 2) a capillary wedge pressure < 18mmHg, and 3) Pao2/Fio2 ratio < 300 via blood gas analysis. In those patients without a Swan-Ganz catheter to determine capillary wedge pressure, the absence of signs of, or clinical concern, for elevated left sided atrial pressures will be used for the diagnosis. All patients who remain intubated beyond the first 24 hours post-injury will be evaluated using blood gas analysis and chest x-ray evaluation. Those patients who remain intubated at 48 hours through 7 days will be reevaluated for this outcome at these time points. The diagnosis of TRALI will be defined as when ALI occurs within the first 6 hours from arrival at the trauma center as it is clinically defined.|hospitalization||||Participants|||Count of Participants
2633946|NCT01818427|Secondary|Multiple Organ Failure|Organ dysfunction will be evaluated via a well-validated scoring system referred to as the Multiple Organ Dysfunction Score (MODScore). Patients who are never admitted to the ICU or those with a length of ICU stay of less than 48 hours will be considered to have a MODScore of 0. A summary of the MODScore may be calculated by summing the worst scores of each of the individual systems over the course of the ICU stay (Table 1). A summary MODScore > 5 will be classified as multiple organ failure (MOF). Scores will be determined daily up until post injury day 28 or ICU discharge.|during hospitalization||||Participants|||Count of Participants
2633947|NCT01818427|Secondary|In-hospital Mortality|In hospital mortality will be prospectively recorded from the time of trauma bay arrival. Over the first 24 hours we will document and record the time of death in hours, while after the 24 hour time point, we will document and record the time of death in days from arrival. We suspect that patients in hemorrhagic shock will have a significant percentage of mortality occurring in the first 24 hour period.|during hospitalization||||Participants|||Count of Participants
2633948|NCT01818427|Secondary|Twenty Four-Hour Blood Transfusion Requirements|24-hour blood transfusion requirements will be determined by recording blood volume (mls) and number of Units transfused from the time of trauma bay arrival or upon completion of pre-hospital initiated plasma infusion. For survival bias analysis, volumes and number of blood transfusion Units received at 3, 6, 12, and 18 hours will also be recorded.|at twenty four hours||||units of blood||Inter-Quartile Range|Median
2633949|NCT01818427|Primary|Our Primary Outcome for the Proposal Will be 30 Day Mortality|All cause 30 day mortality using imputation for those with missing 30 day mortality.|30 days|10 patients in each arm were lost to follow-up for 30-day mortality and 22 patients total, 8 in the plasma arm and 12 in the standard care arm withdrew consent and 1 patient in each arm was a prisoner and could not be included in the analysis cohort. We compared 30-day mortality using a two sided pooled z test with continuity correction.|||Participants|||Count of Participants
2633950|NCT01818414|Secondary|Complications|Incidence of surgical complications related to D&E|Day 1||||participants|||Number
2633951|NCT01818414|Secondary|Number of Providers With Overall Satisfaction|Provider overall satisfaction with cervical preparation|Day 1||||providers|||Number
2633952|NCT01818414|Secondary|Number of Participants With Postoperative Satisfaction|Patient postoperative satisfaction with cervical preparation method|Day 1||||participants|||Number
2633953|NCT01818414|Secondary|Patient Pain|"Change in pain from baseline to immediately preoperatively using a 100-mm Visual Analogue Scale (100-mm Visual Analogue Scale with 0 indicating no pain and 100 indicating worst pain in my life)"|Day 1||||mm||Standard Deviation|Mean
2633954|NCT01818414|Primary|Operative Time|The primary outcome will be operative time. Operative time will be measured from initial passage of an instrument into the uterus to start the D&E. The end of operative time will be measured by the removal of the last instrument from the uterus to complete the D&E.|Day 1 of the study||||minutes||Standard Deviation|Mean
2633955|NCT01818336|Primary|Negative Predictive Value|The primary endpoint was the negative predictive value (NPV), which was estimated as p = percentage of n history-positive subjects with negative skin tests from the Penicillin Allergy Skin Test Kit (as confirmed with an overall negative result for the skin puncture/intradermal testing) who do not experience an IgE-dependent hypersensitivity reaction within 72 hours of the oral amoxicillin challenge.|72 hours|The Intent-to-Treat Population; all subjects with valid skin testing performed (ie, administered all components of the penicillin skin test kit and the histamine/control results were valid), who had negative intradermal skin tests with all 3 Kit reagents, and who received the oral amoxicillin challenge|||percentage of participants||95% Confidence Interval|Number
2633956|NCT01818297|Secondary|Worst Back Pain|Compare the average improvement in worst back pain from Baseline to Month 3 between the Treatment and Control groups. Subjects reported worst back pain (0 (no pain) - 10 (worst pain)) during the Baseline and Blinded Phase (Month 3) periods. Change was calculated as Baseline - Month 3, with a positive change indicating improvement in worst back pain.|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
2633957|NCT01818297|Secondary|Quality of Life: Mental|Compare the average change in quality of life (as measured by Short Form Health Survey (SF36 v2): Mental component score (MCS)) from Baseline to Month 3 between subjects in the Treatment and Control groups. The MCS ranges from 0 (worst possible mental quality of life) to 100 (best possible mental quality of life). Change was calculated as Month 3 - Baseline, with a positive difference indicating improvement in mental quality of life. Subjects with missing Baseline and/or Month 3 SF-36: MCS assessments were counted as no change (Month 3 - Baseline = 0).|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
2633958|NCT01818297|Secondary|Quality of Life: Physical|Compare the average change in quality of life (as measured by Short Form Health Survey (SF36 v2): Physical component score (PCS)) from Baseline to Month 3 between subjects in the Treatment and Control groups. The PCS ranges from 0 (worst possible physicial quality of life) to 100 (best possible physical quality of life). Change was calculated as Month 3 - Baseline, with a positive difference indicating improvement in physical quality of life. Subjects with missing Baseline and/or Month 3 SF-36: PCS assessments were counted as no change (Month 3 - Baseline = 0).|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
2634022|NCT01817777|Secondary|Number of Participants Who Preferred Their Treatment Regimens (Interventional Arm Treatment [Large or Small Pack Metformin]) to How They Previously Took Their Medication|Number of participants who preferred their treatment regimens (interventional arm treatment [large or small pack metformin]) to how they previously took their medication are presented.|Week 28|Per Protocol Population|||Participants|||Number
2633959|NCT01818297|Secondary|Subject Satisfaction|Compare difference in number of subjects satisfied with therapy between the Treatment and Control groups at Month 3. Subjects who reported they were very or somewhat satisfied with the therapy were counted as satisfied. Subjects with no satisfaction response were excluded from the analysis.|3 months|The analysis population includes all randomized subjects, with the exception of one subject in the Control group who did not have a satisfaction value. This subject was excluded from the analysis.|||Participants|||Count of Participants
2633960|NCT01818297|Secondary|Functional Disability|Compare the difference in average improvement in disability (as measured by Oswestry Disability Index (ODI)) from Baseline to Month 3 between the Treatment and Control groups. ODI ranges from 0% (no disability) -100% (greatest disability). Change is calculated as Baseline - Month 3 with a positive change indicating improvement in disability. Subjects with missing Baseline and/or Month 3 ODI assessments were counted as no change (Baseline - Month 3 = 0).|Baseline to 3 months||||units on a scale||Standard Deviation|Mean
2633961|NCT01818297|Primary|Number of Back Pain Responders (Subjects Who Achieve at Least a 50% Reduction in Average Back Pain With no Increase in Prescription Pain Medications) From Baseline to Month 3 Post-device Activation.|Number of responders in Treatment and Control groups. Subjects reported typical back pain (0=no pain, 10=worst pain) during the Baseline (BL) and Blinded Phase (M3) periods. Percentage reduction in average back pain was calculated as (BL-M3)/BL. Subjects with at least a 50% reduction in average back pain between Baseline and Month 3, with no increase in prescribed pain medications, were considered responders.|Baseline to 3 months||||Participants|||Count of Participants
2633962|NCT01818284|Primary|Feasibility in Mobilizing PBPC in Donors: Number of Donors Reaching Stem Cell Target Collection on First Day of Collection Following Treatment of Filgrastim Plus Plerixafor|Study determined to be feasible if all donors were able to receive Plerixafor without developing any grade 2 or higher non-hematologic toxicity. Feasibility of the combination of Filgrastim, Granulocyte-colony stimulating factor (G-CSF) plus Plerixafor is to effectively mobilize CD34+ cells so that an adequate transplant (>4 x 10^6 CD34+ cells/kg) can be reliably collected with one apheresis for allogeneic HSCT.|4 days|Four participants did not receive Plerixafor due to a white blood cell count outside of the protocol specific window. It should be noted, the protocol threshold for white blood cell count was amended from 40,000 to 45,000.|||Participants|||Count of Participants
2633963|NCT01818284|Primary|Summary of Most Common Toxicity: Donor Safety in Mobilizing Peripheral Blood Progenitor Cells (PBPC)|Primary safety endpoint is the development of any unexpected toxicity (any grade 2 or higher non-hematologic toxicity) in donors. The severity of the toxicity - adverse events (AEs) graded according to Common Terminology Criteria v4.0 (CTCAE).|5 days||||adverse events|||Number
2633964|NCT01818245|Secondary|Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A)|Rmax was evaluated across injection sites (abdominal wall, arm, and thigh).|Predose up to 24 hours post clamp procedure in all treatment periods|Participants in Cohort A who received LY2605541 and had evaluable Rmax data.|||milligrams/minute/kilogram (mg/min/kg)||Geometric Coefficient of Variation|Geometric Mean
2633965|NCT01818245|Secondary|Pharmacodynamics: Total Amount of Glucose Infused (Gtot): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A)|Gtot was evaluated across injection sites (abdominal wall, arm, and thigh).|Predose up to 24 hours post clamp procedure in all treatment periods|Participants in Cohort A who received LY2605541 and had evaluable Gtot data.|||milligrams/kilograms (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
2633966|NCT01818245|Primary|Pharmacokinetics: Maximum Plasma Concentration (Cmax): Elderly Participants (≥65 Years of Age) Versus Participants ≤55 Years of Age (Abdominal Injection)|Cmax of LY2605541 was evaluated.|Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose|Participants in Cohort A and B who received LY2605541 in the abdomen and had evaluable Cmax data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2633967|NCT01818245|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC): Elderly Participants (≥65 Years of Age) Versus Participants ≤55 Years of Age (Abdominal Injection)|AUC(0-∞) for LY2605541 was evaluated.|Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose|Participants in Cohort A and B who received LY2605541 in the abdomen and had evaluable AUC(0-∞) data.|||pmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2633968|NCT01818245|Primary|Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A)|Cmax of LY2605541 was evaluated across injection sites (abdominal wall, arm, and thigh).|Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose|Participants in Cohort A who received LY2605541 and had evaluable Cmax data.|||picomoles/liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
2633969|NCT01818245|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A)|AUC from time zero to infinity (AUC(0-∞)) of LY2605541 was evaluated across injection sites (abdominal wall, arm, and thigh).|Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose|Participants in Cohort A who received LY2605541 and had evaluable AUC(0-∞) data.|||picomoles*hours/liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2633970|NCT01818141|Primary|C. Difficile Vegetative Cell Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool|The number and percentage of patients who achieved at least 2 log10 CFU/g of stool reductions of Clostridium difficile vegetative cells from baseline by the end of therapy (days 10-13)|day 10-13||||Participants|||Count of Participants
2633971|NCT01818141|Primary|C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool|The number and percentage of patients who achieved at least 2 log10 colony forming units (CFU)/g of stool reductions of Clostridium difficile spores from baseline by the end of therapy (days 10-13).|day 10-13||||Participants|||Count of Participants
2633972|NCT01818063|Secondary|Relapse Free Survival|Analyzed using Kaplan-Meier methods, stratified by study group, and the log rank test will be completed.|Up to 3 years|Sincere efforts have been made to gather and report the data, however, no data is available for this outcome measure.||||||
2634023|NCT01817777|Secondary|Number of Participants Who Required a Non-routine Health Care Professional Visit for Diabetes|The number of participants who visited a health care professional for diabetes management during the study was summarized.|Week 28|Per Protocol Population|||Participants|||Number
2633973|NCT01818063|Secondary|Overall Clinical Response|"The count and percentage of subjects with each category of overall clinical response will be summarized by presence of baseline measureable disease (i.e., complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD], unable to evaluate [UE], neurogenerative disease [ND]). Evaluated per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) as assessed b MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~Beta will be used as priors for combination regimens in calculating the posterior distribution of the pathologic complete response [pCR] for each respective treatment group. Among subjects with measurable disease, a 95% credible region will be calculated for the odds ratio for each treatment combination relative to each other."|Up to 3 years||||Participants|||Count of Participants
2633974|NCT01818063|Primary|Count of Participants That Achieve Pathologic Complete Response (PCR)|PCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin (H&E) evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes.|36 months following surgery||||Participants|||Count of Participants
2633975|NCT01817959|Other Pre-specified|Frequency of Patients Positive/Negative for Autoantibodies Against Class II Human Leucocyte Antigen (HLA) in Efficacy Population 1|Anti-HLA antibodies were assayed on cell-free serum samples obtained as per centre practice ideally by the Luminex analyzer. Class I and II positive/negative results were recorded.|At pre-transplant, Day 75±5 after the 1st and 2nd islet infusion and Day 365±14 days after the last islet infusion,|The Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (either one or two).|||Percentage of participants|||Number
2633976|NCT01817959|Other Pre-specified|Frequency of Patients Positive/Negative for Autoantibodies Against Class I Human Leucocyte Antigen (HLA) in Efficacy Population 1|Anti-HLA antibodies were assayed on cell-free serum samples obtained as per centre practice ideally by the Luminex analyzer. Class I and II positive/negative results were recorded.|Pre-transplant, day 75±5 after the 1st and 2nd islet infusion and day 365±14 after the last islet infusion|The Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (either one or two).|||Percentage of participants|||Number
2633977|NCT01817959|Other Pre-specified|Frequency of Patients Positive/Negative for Autoantibodies Against Islet Antigen-2 (IA-2) in Efficacy Population 1|Auto-antibodies were assayed on cell-free serum samples obtained as per centre practice ideally by immunoprecipitation of recombinant antigens. The Luminescent Immuno-Precipitation System based on chimeric autoantigens fused to luciferase enzyme was suggested as the preferred method to be used. Luciferase activity was measured in recovered immune-complex.|At pre-transplant, Day 75±5 after the 1st and 2nd islet infusion and Day 365±14 days after the last islet infusion,|The Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (either one or two).|||Percentage of participants|||Number
2633978|NCT01817959|Other Pre-specified|Frequency of Patients Positive/Negative for Autoantibodies Against Glutamic Acid Decarboxylase (GAD) in Efficacy Population 1|Auto-antibodies were assayed on cell-free serum samples obtained as per centre practice ideally by immunoprecipitation of recombinant antigens. The Luminescent Immuno-Precipitation System based on chimeric autoantigens fused to luciferase enzyme was suggested as the preferred method to be used. Luciferase activity was measured in recovered immune-complex.|At pre-transplant, Day 75±5 after the 1st and 2nd islet infusion and Day 365±14 days after the last islet infusion|The Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (either one or two).|||Percentage of participants|||Number
2633979|NCT01817959|Secondary|β-cell Function as Assessed by Transplant Estimated Function (TEF) in Efficacy Population 1|"TEF selects the two pivotal components of the β-score (DIR and A1C) and links them together through a simple description of how insulin supply influences the patient's glycemic control.~TEF was evaluated by the following equation: TEF = a.DIR + b.HbA1c + c where DIR = daily insulin requirement (average in the previous week); a = -1; b = 1/-5.43; c = -a.DIR (pre-transplant) - b.HbA1c (pre-transplant)"|Day 75±5 after the 1st and 2nd islet infusion and day 365±14 after last islet infusion|The Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (either one or two).|||U/kg/24 h||Standard Deviation|Mean
2633980|NCT01817959|Secondary|β-cell Function as Assessed by β-score in Efficacy Population 1|"The β-score ranges from 0 (no graft function) to 8 (interpreted as an index of excellent graft function), and gives 0-2 points each for glucose, HbA1C, stimulated C-peptide and insulin requirement. Both for the total and partial scores the higher the score, the better the outcome.~Fasting plasma glucose (mg/dL): ≤99 (Score 2); 100 - 124 (Score 1); ≥125 (Score 0); HbA1c (%): ≤6.1(Score 2); 6.2 - 6.9 (Score 1); ≥ 7.0 (Score 0); Daily average (previous week) insulin (IU/kg/day): --- (Score 2); 0.01 - 0.24 (score 1); ≥ 0.25 (Score 0) Stimulated C-peptide (ng/mL): ≥ 0.9; 0.3 - 0.89; ≤0.3"|Day 75±5 after the 1st and 2nd islet infusion and day 365±14 after last islet infusion|The Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (either one or two).|||score on a scale||Standard Deviation|Mean
2633981|NCT01817959|Secondary|Basal (Fasting) and 0 to 120 Min Time Course of Insulin Derived From the MMTT in Efficacy Population 1|Insulin levels were measured at the baseline in fasting condition, and at the following timepoints: 15, 30, 60, 90, 120 min after mixed meal at the hereunder reported time frame.|Day 75±5 after the 1st and 2nd islet infusion and day 365±14 after last islet infusion|The Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (either one or two).|||µU/mL||Standard Deviation|Mean
2633982|NCT01817959|Secondary|Basal (Fasting) and 0 to 120 Min Time Course of C-peptide (Non-normalized) Derived From the MMTT in Efficacy Population 1|C-peptide levels not normalized by the number of islet equivalent (IEQ)/kg were measured at the baseline in fasting condition, and at the following timepoints: 15, 30, 60, 90, 120 min after mixed meal at the hereunder reported time frame.|Day 75±5 after the 1st and 2nd islet infusion and day 365±14 after last islet infusion|The Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (either one or two).|||ng/mL||Standard Deviation|Mean
2635706|NCT01800162|Secondary|Number of Visits|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|6 weeks|||||||
2633983|NCT01817959|Secondary|Basal (Fasting) and 0 to 120 Min Time Course of Glucose Derived From the Mixed Meal Tolerance Test (MMTT) in Efficacy Population 1|Glucose levels were measured at the baseline in fasting condition, and at the following timepoints: 15, 30, 60, 90, 120 min after mixed meal at the hereunder reported time frame.|Day 75±5 after the 1st and 2nd islet infusion and day 365±14 after last islet infusion|The Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (either one or two).|||mg/dL||Standard Deviation|Mean
2633984|NCT01817959|Secondary|Percent Change in HbA1c % From Pre-transplant Levels in Efficacy Population 1|Change from baseline in Glycated haemoglobin (HbA1c) was assessed as percentage decrease from pre-transplant levels. Diagnostic standards for HbA1c from American Diabetes Association are: <5.7% Normal; 5.7-6.4% prediabetes; >6.5 diabetes.|Day 75±5 after the 1st and 2nd islet infusion and day 365+14 after last islet infusion|The Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (either one or two).|||Percent change of Hb1Ac %||Standard Deviation|Mean
2633985|NCT01817959|Secondary|Absolute Change in HbA1c % From Pre-transplant Levels in Efficacy Population 1|Change from baseline in Glycated haemoglobin (HbA1c) was assessed as absolute decrease from pre-transplant levels. Diagnostic standards for HbA1c from American Diabetes Association are: <5.7% Normal; 5.7-6.4% prediabetes; >6.5 diabetes.|Day 75±5 after the 1st and 2nd islet infusion and day 365±14 after last islet infusion|The Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (either one or two).|||percent of HbA1c||Standard Deviation|Mean
2633986|NCT01817959|Secondary|Percent Change From Baseline in Average Daily Insulin Requirements in Efficacy Population 1|Change from baseline is assessed as percentage decrease from pre-transplant levels. For the purpose of this study, daily insulin is averaged over the previous week.|Day 75±5 after the 1st and 2nd islet infusion and day 365±14 after last islet infusion|The Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (either one or two).|||Percentage change||Standard Deviation|Mean
2633987|NCT01817959|Secondary|Absolute Change From Baseline in Average Daily Insulin Requirements in Efficacy Population 1|Change from baseline is assessed as absolute decrease from pre-transplant levels. For the purpose of this study, daily insulin is averaged over the previous week.|Day 75±5 after the 1st and 2nd islet infusion and day 365±14 after last islet infusion|The Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (either one or two).|||IU/kg/day||Standard Deviation|Mean
2633988|NCT01817959|Secondary|Cumulative Number of Severe Hypoglycaemic Events in the Efficacy Population 1|The cumulative number of severe hypoglycaemic events after last transplant was assessed. For the purpose of this study, a severe hypoglycaemic event is defined as an event with one of the following symptoms: memory loss, confusion, uncontrollable behaviour, irrational behaviour, unusual difficulty in awakening, suspected seizure, seizure, loss of consciousness or visual symptoms, in which the subject was unable to treat him/herself and which was associated with either a blood glucose level <54 mg/dL (3.0 mmol/L) or prompt recovery after oral carbohydrate, i.v. glucose, or glucagon administration.|Day 365±14 after the last islet infusion|Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (either one or two).|||number of events||Standard Deviation|Mean
2633989|NCT01817959|Secondary|Percentage of Patients Who Did Not Receive a 2nd Islet Infusion|This endpoint describes subjects who were not allocated to a 2nd islet infusion because they were insulin independent after the 1st islet infusion.|Day 365±14 after the 1st islet infusion|Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (either one or two).|||percentage of participants|||Number
2633990|NCT01817959|Secondary|Percentage of Patients Who Achieve and Maintain an HbA1c <7.0% (or a Reduction in HbA1c > 2%) AND Are Free of Severe Hypoglycaemic Events After Transplant in the Efficacy Population 1|For the purpose of this study, a severe hypoglycaemic event is defined as an event with one of the following symptoms: memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure, loss of consciousness or visual symptoms, in which the subject was unable to treat him/herself and which was associated with either a blood glucose level <54mg/dL (3.0 mmol/L) or prompt recovery after oral carbohydrate, i.v. glucose, or glucagon administration.|HbA1c at Day 365±14 after the last islet infusion; severe hypoglycaemic events from Day 75 to Day 365 after the last islet infusion|The Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (one or two).|||Percentage of participants|||Number
2633991|NCT01817959|Secondary|Percentage of Insulin-independent Patients at Day 365|"For the purpose of this study, insulin-independence is defined as freedom from the need to take exogenous insulin for 14 or more consecutive days, with adequate glycaemic control, as defined by:~a glycated hemoglobin (HbA1c) level of less than 7%;~a glucose level after an overnight fast not exceeding 140 mg/dL (7.8 mmol/L) more than three times a week (based on measuring capillary glucose level a minimum of 7 times in a 7 day period);~a glucose level not exceeding 2-hour postprandial levels of 180 mg/dL (10 mmol/L) more than four times a week (based on measuring capillary glucose level 14 times in a 7 day period)."|Day 365±14 after last islet infusion|The Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (either one or two).|||percentage of participants|||Number
2633992|NCT01817959|Secondary|Percentage of Insulin-independent Patients at Day 75|"For the purpose of this study, insulin-independence is defined as freedom from the need to take exogenous insulin for 14 or more consecutive days, with adequate glycaemic control, as defined by:~a glycated hemoglobin (HbA1c) level of less than 7%;~a glucose level after an overnight fast not exceeding 140 mg/dL (7.8 mmol/L) more than three times a week (based on measuring capillary glucose level a minimum of 7 times in a 7 day period);~a glucose level not exceeding 2-hour postprandial levels of 180 mg/dL (10 mmol/L) more than four times a week (based on measuring capillary glucose level 14 times in a 7 day period)."|Day 75±5 after the 1st and 2nd islet infusion|The Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (either one or two).|||Percentage of participants|||Number
2639590|NCT01763905|Secondary|Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2633993|NCT01817959|Primary|Area Under the Curve (AUC) for the Serum C-peptide Level During the First 2 Hours of an MMTT (Mixed Meal Tolerance Test), Normalized by the Number of Islet Equivalent (IEQ)/kg|The MMTT was to be performed ideally after an overnight fast. The test was to be initiated before 10 a.m. The Boost Original complete nutritional drink (Nestlé Nutrition) was used for the MMTT. Subjects were given 6 mL/kg of Boost preparation up to a maximum of 360 mL, to be drunk within 5 min. Blood samples for the C-peptide assay (the primary assessment) were withdrawn in fasting condition (basal), just prior to the meal (time 0, within 15 min prior to the meal) and then at 15, 30, 60, 90, 120 min after the meal.|Basal, -15' prior to meal, 15', 30', 60', 90', 120' following meal, Day 365±14 after the last islet infusion|The Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (either one or two).|||ng/mL/min||Standard Deviation|Mean
2633994|NCT01817959|Primary|Area Under the Curve (AUC) for the Serum C-peptide Level During the First 2 Hours of an MMTT (Mixed Meal Tolerance Test), Normalized by the Number of Islet Equivalent (IEQ)/kg|The MMTT was to be performed ideally after an overnight fast. The test was to be initiated before 10 a.m. The Boost Original complete nutritional drink (Nestlé Nutrition) was used for the MMTT. Subjects were given 6 mL/kg of Boost preparation up to a maximum of 360 mL, to be drunk within 5 min. Blood samples for the C-peptide assay (the primary assessment) were withdrawn in fasting condition (basal), just prior to the meal (time 0, within 15 min prior to the meal) and then at 15, 30, 60, 90, 120 min after the meal.|Basal, -15' prior to meal, 15', 30', 60', 90', 120' following meal, Day 75±5 after the 1st islet infusion|The Efficacy Population 1 consisted of all subjects who were randomised, received the IP (either Reparixin or placebo), and had a transplant (either one or two).|||ng/mL/min||Standard Deviation|Mean
2633995|NCT01817907|Secondary|Arousal Threshold (cmH2O)|Subjects will have an epiglottic pressure catheter placed during their sleep studies. We will use the swing in the epiglottic pressure trace just prior to arousal to calculate the respiratory drive stimulus that is associated with an a respiratory induced arousal.|Participants will be assessed on 2 nights over an average period of 2 weeks.|two subjects were excluded from analysis because of excessive number of artifacts|||cmH2O||Standard Deviation|Mean
2633996|NCT01817907|Primary|Apnea-Hypopnea Index|The Apnea-Hypopnea Index (AHI) is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow).|Participants will be assessed on 2 nights over an average period of 2 weeks.|two subjects were excluded from analysis because of excessive number of artifacts|||events/hour||Standard Error|Mean
2633997|NCT01817855|Secondary|Summary of Pharmacokinetic Parameters (Cmin)|"Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9. Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device).~Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken."|PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3.|PK analysis set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2633998|NCT01817855|Secondary|Summary of Pharmacokinetic Parameters (Cmax)|"Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9. Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device).~Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken."|PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3.|PK analysis set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2633999|NCT01817855|Secondary|Summary of Pharmacokinetic Parameters (AUC(0-tau) )|"Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9.~*AUC(0-tau) = AUC(0-last) where for cohorts 2,3,4,5 and 6 tau=24 hours and for cohort 1, tau=12 hours .~Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device).~Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken."|PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3.|PK analysis set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2634000|NCT01817855|Primary|Adverse Events|Summary of number of subjects who had at least one adverse event in any category (Safety analysis set)|Up to 24 days||||Participants|||Number
2634001|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Other Symptoms|"MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Other Symptoms is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled)."|Baseline to 14 days|"All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of other symptoms, data of one participant each from the two groups are unavailable."|||Score on a scale||Standard Deviation|Mean
2634002|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Eye Symptoms|"MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Eye Symptoms is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled)."|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of eye symptoms, data of one participant each from the two groups are unavailable.|||Score on a scale||Standard Deviation|Mean
2634024|NCT01817777|Secondary|Number of Participants With Diabetes Disease Management Modifications|Throughout the duration of the study, participants remained on their recommended metformin dosing regimens, unless a change in metformin dose was prescribed by their physician. The number of participants who received additional diabetes therapy for the management of diabetes was summarized.|Week 28|Per Protocol Population|||Participants|||Number
2634003|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Nose Symptoms|"MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Nose Symptoms is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled)."|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of nose symptoms, data of one participant each from the two groups are unavailable.|||Score on a scale||Standard Deviation|Mean
2634004|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Practical Problems|MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. 'Practical Problems' is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
2634005|NCT01817790|Secondary|Mean Changes From Baseline in Individual MiniRQLQ Scores: Domain - Activities|MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. Activity limitations is one of the domains of Mini RQLQ scores. Participants scored their degree of impairment on a seven-point scale (0 = not troubled, 6 = extremely troubled).|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
2634006|NCT01817790|Secondary|Mean Changes From Baseline in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Scores|MiniRQLQ is a 14-item, disease-specific instrument for assessing the impact of allergic rhinitis on activities of daily living and overall well-being. It measures five domains of functional impairment that are most important to subjects with SAR: practical problems, nasal symptoms, eye symptoms, activity limitations, and other symptoms. Participants scored their degree of impairment on a seven-point scale. (0 - 6). Mini RQLQ final score is the average of sub-scales, ranges from 0 (best possible outcome) to 6 (worst possible outcome).|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. For analysis of nose symptoms, eye symptoms, and other symptoms, data of one participant each from the two groups are unavailable.|||Score on a scale||Standard Deviation|Mean
2634007|NCT01817790|Secondary|Mean Change in Objective Assessment of Conjunctival Redness|Conjunctival redness was evaluated as a clinical sign of SAR by the investigator. Scoring of severity was rated according to a 4-point scale: 0 = normal; 1 = Slightly pink; 2 = Moderately pink, some dilation; 3 = Intense red vessels, dilated.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
2634008|NCT01817790|Secondary|End-of-treatment Assessment of Response to Therapy for Ocular Symptoms|Overall response to therapy assessment was done using a 7-point categorical scale in which participants rated their response to therapy as follows: +3 = Significantly Improved; +2 = Moderately Improved; +1 = Mildly Improved; 0 = No Change; -1= Mildly Worse; -2 = Moderately Worse; -3 = Significantly Worse.|Day 14|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population. In this outcome measure, in Fluticasone propionate group 313/314 participants, and in the placebo group 309/312 participants provided responses.|||Participants|||Number
2634009|NCT01817790|Secondary|Mean Change From Baseline in Reflective Nasal Congestion Symptom Score (rNCSS)|The rNCSS is a participant perceived evaluation of overall congestion symptom severity (evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe) which was completed once in the evening (PM), and once in the morning (AM). rNCSS is defined as the average of the PM rNCSS and the AM rNCSS of the next day prior to AM dosing. The mean change from baseline in rNCSS (daily, AM, PM)was calculated as the subject's treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
2634010|NCT01817790|Secondary|Mean Change From Baseline in AM Pre-dose Instantaneous Total Ocular Symptom Scores (iTOSS)|Instantaneous total ocular symptom scores (iTOSS) assessments are self perceived evaluation of symptom severity immediately before the dose (how the subject feels at that point in time). iTOSS (possible score of 0-9) is the sum of 3 individual participant-assessed symptom scores for eye itching/burning, eye tearing/watering, and eye redness each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. Mean changes from baseline were calculated as treatment period iTOSS minus baseline iTOSS.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
2634011|NCT01817790|Secondary|Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Redness|The PM Reflective Ocular Symptom Score was assessed individually for eye redness using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye redness) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
2634025|NCT01817777|Secondary|Number of Participants Who Took Zero Metformin Pills for the Indicated Number of Days|The number of days on which no metformin pills were taken by participants was summarized.|Week 28|Per Protocol Population|||Participants|||Number
2634012|NCT01817790|Secondary|Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Redness|The AM Reflective Ocular Symptom Score was assessed individually for eye redness using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye redness) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
2634013|NCT01817790|Secondary|Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Tearing/Watering|The PM Reflective Ocular Symptom Score was assessed individually for eye tearing/watering using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye tearing/watering) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
2634014|NCT01817790|Secondary|Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Tearing/Watering|The AM Reflective Ocular Symptom Score was assessed individually for eye tearing/watering using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye tearing/watering) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
2634015|NCT01817790|Secondary|Mean Change From Baseline in Individual PM Reflective Ocular Symptom Scores for Eye Itching/Burning|The PM Reflective Ocular Symptom Score was assessed individually for eye itching/burning using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM Reflective Ocular Symptom Score (eye itching and burning) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
2634016|NCT01817790|Secondary|Mean Change From Baseline in Individual AM Reflective Ocular Symptom Scores for Eye Itching/Burning|The AM Reflective Ocular Symptom Score was assessed individually for eye itching/burning using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For evaluation, subjects completed the scoring in the morning, prior to nasal spray use. The mean change from baseline in AM Reflective Ocular Symptom Score (eye itching and burning) was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
2634017|NCT01817790|Secondary|Mean Change From Baseline in PM rTOSS|rTOSS is the sum of 3 individual participant-assessed symptom scores (eye itching/ burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For PM rTOSS, subjects completed rTOSS in the evening, 12 hours post morning nasal spray use. The mean change from baseline in PM rTOSS was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
2634018|NCT01817790|Secondary|Mean Change From Baseline in AM rTOSS|rTOSS is the sum of 3 individual participant-assessed symptom scores (eye itching/ burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. For AM rToss, subjects completed rTOSS in the morning (AM score: prior to nasal spray use). The mean change from baseline in AM rTOSS was calculated as the subject's treatment period mean (over 14 days) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
2634019|NCT01817790|Primary|Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS)|The Reflective Total Ocular Symptom Score (rTOSS) is the sum of 3 individual participant-assessed symptom scores (eye itching/burning, eye tearing/watering, and eye redness), each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe, for a possible score of 0-9. Subjects completed rTOSS in the evening (PM rTOSS; 12 hours post morning nasal spray use) and once in the morning (AM score: prior to nasal spray use). Daily (i.e. during one dosing interval) rTOSS is defined as the average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The mean change from baseline in (daily, AM, PM) TOSS was calculated as the subject's treatment period mean (over 14 days; from Day 0 PM to Day 14 AM) minus the baseline period (placebo run-in) mean.|Baseline to 14 days|All subjects who were randomized into the study and received at least one dose of study product were included in the intent-to-treat (ITT) population. This analysis was conducted on ITT population.|||Score on a scale||Standard Deviation|Mean
2634020|NCT01817777|Secondary|Number of Participants Withdrawn From the Study Due to the Following Reasons: Withdrawal of Informed Consent; Lost to Follow-up|The number of participants who voluntarily discontinued participation in the study at any time or who were withdrawn by the investigator for pre-defined reasons was summarized.|Week 28|Observational Population: all participants enrolled into the study. If an enrolled participant withdrew from the study prior to the Week 8 visit, all available data on the participant was included in the Observational Population.|||Participants|||Number
2634026|NCT01817777|Secondary|Mean Percent Compliance Throughout the Observational Phase, Per Treatment They Were Randomized to in the Interventional Phase|Compliance was estimated during the 8-week Observational Phase for usual metformin treatment. During the Observational Phase, compliance was measured by monitoring the number of pill dispensed and the return of the pills or tablets.|From enrollment to Week 8|Per Protocol Population|||Percent compliance||Standard Deviation|Mean
2634027|NCT01817777|Secondary|Mean Percent Compliance Throughout the Interventional Phase|Compliance for the study was estimated as a percentage, with the denominator defined as the number of pills dispensed by the pharmacist and the numerator defined as the number of pills taken, accounting for remaining pills at subsequent pharmacy visits.|From Randomization to Week 28|Per Protocol Population|||Percent compliance||Standard Deviation|Mean
2634028|NCT01817777|Primary|Change From Baseline in HbA1c Values at Week 28|HbA1c was tested with a point-of-care device, which required a finger prick to obtain blood and provided an immediate result upon analysis in the device. HbA1c was tested at pharmacy visits corresponding to three time points: enrollment (Week 0), Baseline (Week 8), and End of Study (Week 28). The difference in the mean change from Baseline was to be calculated between the treatment arms (small pack minus large pack), and the 2-sided 95% confidence interval for the difference in mean change in HbA1c was to be calculated. However, because the study was terminated early, and the sample size was reduced, the statistical hypotheses defined in the protocol were not tested due to insufficient power. Therefore, the final analyses were limited to descriptive statistics. The percentage HbA1c is a measure of how much of the hemoglobin in the blood has become glycated (chemically bounded to glucose).|Baseline (Week 8) and Week 28|Per Protocol Population: all participants in the Intent-to-Treat Population (randomly assigned to treatment and who received >= 1 dose [or any portion of a dose] of study medication and had an HbA1c test at Week 8) who did not have a protocol violation|||Percentage||Standard Deviation|Mean
2634029|NCT01817764|Secondary|Change From Baseline in Trough FEV1 on Day 85|Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after morning dosing/11 and 12 hours after evening dosing on Day 84. Change from Baseline is calculated as the Day 85 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, day, and day by Baseline and day by treatment interactions.|Baseline and Day 85|ITT Population. Only those participants with analyzable data at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
2634030|NCT01817764|Primary|Change From Baseline in 24-hour Weighted-mean Serial FEV1 on Treatment Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5 and 15 minutes and 1, 3, 6, 9, 12 (pre-evening dose), 13, 15, 18, 23, and 24 hours after the morning dose. Change from Baseline was calculated as the value at Day 84 minus the value at Baseline. Analysis was performed using an analysis of covariance of treatment, Baseline (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), and smoking status. par.=participants.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received >=1 dose of randomized study medication in the treatment period. Only par. with analyzable data at the indicated time point were assessed, but all par. without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2634031|NCT01817725|Secondary|Anti-HBs Seropositivity||2 years||||Participants|||Count of Participants
2634032|NCT01817725|Primary|Change in HBsAg Levels From Baseline to 2 Years|The difference of HBsAg levels at the end of follow up (2 years) and baseline|2 years||||log IU/ml||Standard Deviation|Mean
2634033|NCT01817712|Secondary|Change in PCL-5 Score of PTSD Symptoms|PTSD Symptoms are assessed every three months during the follow-up period using the self-report PTSD Checklist (PCL-5) that the participant completes during the follow-up visits. Range of values 0-80 (higher score is worse).|18-months (Change from baseline)||||units on a scale||95% Confidence Interval|Least Squares Mean
2634034|NCT01817712|Secondary|Cumulative Gross Income|Cumulative Gross Income is collected using the Employment Calendar source document and Employment Calendar Reconciliation case report form used for the primary outcome ascertainment. When possible, the CRC verifies income earned by reviewing paycheck stubs that the participant is instructed to maintain with the Employment Calendar.|Weekly for 78 weeks||||Dollars||Inter-Quartile Range|Median
2634035|NCT01817712|Primary|Number of Participants Who Obtained and Maintained Competitive Employment for at Least 50% of the Active Follow-up Period|"The primary outcome will be achievement of a steady worker status, defined as obtaining and maintaining competitive employment for at least 50% of the active follow-up period (i.e., greater than or equal to 39 weeks)."|78 weeks||||Participants|||Count of Participants
2634036|NCT01817582|Secondary|Change From Baseline in Non-Invasive Keratographic Limbal and Bulbar Ocular Redness Scores for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator|The objective redness scoring assessment was conducted by automated means using an Oculus Keratograph 5M. Duplicate digital photographs of bulbar and limbal conjunctiva were taken with the Oculus Keratograph 5M instrument for each eye of a participant and the images were analyzed using R-Scan classification software to numerically rate the severity of ocular redness (bulbar and limbal redness) on a 4-point (0-3) grading scale, where score 0 = none absent; no redness present in the white of the eyes, 1 = mild, slightly dilated blood vessels seen in some portion of white of the eyes; color of vessels was typically pink, 2 = moderate more apparent dilation of blood vessels in the white of the eyes; vessel color was more intense (redder) and involves the majority of the vessel bed, 3 = severe numerous obvious dilated blood vessels throughout the white of the eyes; the vessel color was deep red. Keratograph 5M ocular redness grading results were averaged for each eye and for both eyes.|Baseline, Week 12|ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.|||units on a scale||Standard Deviation|Mean
2634103|NCT01816893|Secondary|Muscle Sympathetic Nerve Activity|Muscle sympathetic nerve activity (MSNA), at rest and immediately after nitroprusside, was measured on Day 3 about 16 hours after the euglycemic and hypoglycemic clamps.|16 hours after euglycemic and hypoglycemic clamps|20 subjects completed both arms, but only 5 had the muscle sympathetic nerve activity outcome for both arms.|||bursts/ minute||Standard Deviation|Mean
2634037|NCT01817582|Secondary|Change From Baseline in Ocular Redness Score for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator|The Investigator subjectively rated the degree of eye redness on a 4-point (0-3) grading scale prior to any objective grading of eye redness for a participant, where score 0 = none absent; no redness present in the white of the eyes, 1 = mild, slightly dilated blood vessels seen in some portion of the white of the eyes; the color of vessels was typically pink, 2 = moderate more apparent dilation of blood vessels in the white of the eyes; vessel color was more intense (redder) and involves the majority of the vessel bed, 3 = severe numerous obvious dilated blood vessels throughout the white of the eyes; the vessel color was deep red.|Baseline, Week 12|ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.|||units on a scale||Standard Deviation|Mean
2634038|NCT01817582|Secondary|Number of Participants With Overall Change From Baseline in Dry Symptoms at Week 12 as Assessed Independently by Investigators and Participants|Participants and investigators independently rated the overall change from baseline in dry eye conditions for each participant on a 7-point Likert scale at Week 12. The scale ranged from +3 to -3, where +3 = Substantial improvement in dry eye; little or no awareness of dry eye, +2 = Some improvement in dry eye, +1 = Little improvement in dry eye, 0 = No improvement in dry eye, −1 = Slight worsening of dry eye, −2 = Some worsening of dry eye, and −3 = Substantial worsening of dry eye.|Baseline, Week 12|ITT population included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for specified categories; that is, participants who had investigator global improvement assessment or participant-reported global improvement assessments.|||Participants|||Count of Participants
2634039|NCT01817582|Secondary|Averaged Daily Soothe Lubricant Eye Drops Usage|Amount of averaged daily soothe lubricant eye drops (Bausch + Lomb) used was reported.|Baseline up to Week 12|ITT population included all randomized participants.|||drops/day||Standard Deviation|Mean
2634040|NCT01817582|Secondary|Change From Baseline in Mean Anesthetized Schirmer's Test Values (Distance of Strips Wetting) in the Study Eye and Averaged for Both Eyes of a Participant at Week 13|Schirmer's test measures the aqueous component of tear secretion. The Schirmer's test (anesthetized) is a measure of the tonic secretion of the aqueous component of tears. A Schirmer's test (with anaesthesia) was performed for both eyes of a participant using Schirmer's test strips. After instillation of an ophthalmic anaesthetic, Schirmer's test strips for each eye were left in place for 5 minutes with participant eyelids closed. After 5 minutes, the Schirmer's test strips were removed with forceps and the distance to where each strip was wetted was recorded in millimeters (mm). Lesser wetting of strips (low levels of tear production) were associated with dry eye.|Baseline, Week 13|ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.|||mm||Standard Deviation|Mean
2634041|NCT01817582|Secondary|Change From Baseline in Mean Non-Invasive Keratographic Tear Film Breakup Time (NIKBUT) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12|The tear film breakup time was defined as the interval between the last complete blink and the first appearance of dark zones or spots, or disruption in the tear film. Tear film examination using any non-invasive method analyzes optical reflections from the cornea. Reflections that become distorted are characteristic of tear film breakup. Circular images were projected onto the corneal surface using an Oculus Keratograph 5M instrument, and the tear film reflection was observed on a computer. NIKBUT (initial break-up time [NIKBUTi] and average break-up time [NIKBUTav]) were determined and recorded for each eye in duplicate after participant blink 2 times. NIKBUT at Baseline (Day 0) was subtracted from NIKBUT at Week 12 (Day 84) and reported as change. A higher number represented a lengthening in the NIKBUT. A longer NIKBUT indicated a more stable tear film.|Baseline, Week 12|ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.|||seconds||Standard Deviation|Mean
2634042|NCT01817582|Secondary|Change From Baseline in Mean Tear Film Breakup Time (TFBUT) (by Fluorescein Staining) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12|"The TFBUT was defined as the interval between the last complete blink and the first appearance of dark zones or spots, or disruption in the tear film. Tear film breakup time is a measure of the stability of the tear film protecting the cornea and bulbar conjunctiva. 5 microliters (μL) of fluorescein solution was instilled in the participant's eye, after which the participant blinked several times, then kept the eye open. The cornea was visualized through the slit lamp using appropriate barrier filters for the white light source.~TFBUT was counted using a stopwatch. Three consecutive measurements were taken and averaged for actual TFBUT. TFBUT at Baseline (Day 0) was subtracted from TFBUT at Week 12 (Day 84) and reported as change. A higher number represented a lengthening in the TFBUT. A longer TFBUT indicated a more stable tear film."|Baseline, Week 12|ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.|||seconds||Standard Deviation|Mean
2634043|NCT01817582|Secondary|Change From Baseline in Mean Eye Dryness Questionnaire Total and Individual Question Scores at Week 12|The 5-item Dry Eye Questionnaire (DEQ-5) is a validated questionnaire for discriminating self-assessed severity of dry eye diagnoses. The participants rated the frequency on a scale of 0 (never) to 4 (constant) with which they have experienced 3 symptoms (watery eyes, discomfort and dryness). The participant was also asked to rate the increase in intensity of discomfort and dryness throughout the day on a scale of 0 (never have it) to 5 (very intense). Participant rated the overall severity of dry eye symptoms on a scale of 0 (no problem) to 4 (intolerable; unable to perform my daily tasks). Total DEQ-5 score was the sum of scores for frequency and intensity of dryness and discomfort plus frequency of watery eyes. A DEQ-5 total score >6 was indicative of DED and a score >12 is indicative of Sjögren's syndrome.|Baseline, Week 12|ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.|||units on a scale||Standard Deviation|Mean
2634051|NCT01817582|Primary|Mean Grade for Participant-Reported Post-Dosing Ocular Comfort Values|Participants scored their degree of comfort with their assigned study drug on a 4-point scale (0-3 units) within 5 minutes after instillation of study drug. Comfort grade 0 indicated comfortable, discomfort absent; 1 indicated generally comfortable, mild discomfort; 2 indicated some discomfort but tolerable, moderate discomfort; 3 indicated severely uncomfortable or intolerable. The mean global ocular comfort grade was reported.|Week 12|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2634044|NCT01817582|Secondary|Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12|An ocular comfort assessment questionnaire was administered at weeks 2, 4, and 12 to participants. The assessment of the degree of dry eye discomfort experienced by the participant was conducted using an adapted and validated 12-item ocular comfort questionnaire ( to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching) based upon the ocular comfort index of Johnson and Murphy. Each item (question) was graded from 0 to 4, where 0 = Not at all, 1 = Seldom; perceptible but not intense, 2 = Sometimes; intermittent with easily tolerable intensity, 3 = Frequently; often but with tolerable intensity, 4 = Constantly; constant or intolerable intensity. Total score was calculated and normalized to a score of 0 (no discomfort)-100 (more ocular discomfort) by the formula: Normalized comfort grade = ([Total Comfort Grade] * 100)/48.|Baseline, Week 12|ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.|||units on a scale||Standard Deviation|Mean
2634045|NCT01817582|Secondary|Change From Baseline in Mean Tear Osmolarity Between Two Eyes of Participant at Week 12|Tear osmolarity was measured with the TearLab Osmolarity System. The TearLab instrument measures the impedance of 50 nL tear samples taken with a disposable lab-on-a-chip device. Tear samples from enrolled participants were taken at Weeks 2, 4, and 12 from each eye in duplicate with a tear sampler according to the manufacturer's instructions, and the tear osmolarity for each sample was read with the TearLab instrument. Osmolarity values were provided by the TearLab instrument in 3-digit units of mOsm. Change from mean baseline values for all participants within a treatment group was calculated for the difference between average values between 2 eyes at Week 12.|Baseline, Week 12|ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable at specified timepoints.|||mOsm||Standard Error|Mean
2634046|NCT01817582|Secondary|Change From Baseline in Mean Tear Osmolarity of Participant Worst Eye Value at Week 12|Tear osmolarity was measured with the TearLab Osmolarity System. The TearLab instrument measures the impedance of 50 nanoliters (nL) tear samples taken with a disposable lab-on-a-chip device. Tear samples from enrolled participants were taken at Weeks 2, 4, and 12 from each eye in duplicate with a tear sampler according to the manufacturer's instructions, and the tear osmolarity for each sample was read with the TearLab instrument. Osmolarity values were provided by the TearLab instrument in 3-digit units of milliosmoles (mOsm). Change from mean baseline values for all participants within a treatment group was calculated using a participant's worst eye value at Week 12.|Baseline, Week 12|ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable at specified timepoints.|||mOsm||Standard Deviation|Mean
2634047|NCT01817582|Secondary|Change From Baseline in Mean Total Combined Lissamine Green (LG) Staining (Nasal Plus Temporal Conjunctival) Score for the Study Eye and Averaged for Both Eyes at Week 12|LG staining is useful for monitoring evidence of eye dryness in conjunctival tissue. Scoring of conjunctival staining was done using Oxford conjunctival grading scale. The investigator instilled an ophthalmic dye (LG stain) on the eye and rated staining in 2 areas (nasal and temporal conjunctiva). Staining was rated on a 6-point scale from 0 (absent) to 5 (severe). The total score ranged from 0 (improvement; no conjunctival damage) to 12 (worsening; severe conjunctival damage).|Baseline, Week 12|ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.|||units on a scale||Standard Deviation|Mean
2634048|NCT01817582|Secondary|Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12|Participants eligible for enrollment rated the severity of dry eye symptoms at Baseline (Day 0) on a 5-point grading scale (ranged from 0 [no problem] to 4 [continuous or severe discomfort; intolerable]) for each of 8 symptoms in the following symptom list prior to enrollment and then selected their most bothersome symptom: Photophobia, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness or blurriness, eye discomfort, burning or stinging, or photopsia (sensation of light or light flashes). Participants subsequently rated their dry eye symptom severity on the same 5-point grading scale at Week 2-Week 12 for study eye for the worst symptom identified at Baseline.|Baseline, Week 12|ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.|||units on a scale||Standard Deviation|Mean
2634049|NCT01817582|Secondary|Change From Baseline in Mean Corneal Total Fluorescein Staining Score for the Study Eye and Averaged for Both Eyes at Week 12|Fluorescein Corneal Staining indicates the damage to the corneal epithelium (corneal epitheliopathy). Punctate corneal staining with fluorescein was evaluated and graded according to the NEI grading method. The cornea was divided into 5 regions: central, superior, inferior, nasal and temporal. Each of these 5 regions was graded from scores 0 to 3, where 0 indicated no staining (absent) and 3 maximal staining (severe damage). The total score was the sum of all these regions, ranged from 0 (absence of corneal epitheliopathy) to 15 (severe corneal epitheliopathy).|Baseline, Week 12|ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.|||units on a scale||Standard Deviation|Mean
2634050|NCT01817582|Secondary|Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12|"OSDI is a 12-item questionnaire developed to assess severity of DED. There are 3 question types: Have you experienced any of following (light sensitivity, eye feel gritty, sore eyes, blurred vision, and poor vision) during last week?(items 1-5); Have problems with your eyes limited you in performing any of following (reading, driving at night, working with computer, and watching TV) during last week? (items 6-9); and Have your eyes felt uncomfortable in any of following situations (windy, low humidity, air conditioned) during the last week? (items 10-12). Response of each of these questions were graded on a scale (that relate to the frequency of ocular surface disease effects) of 0 (none of the time) to 4 (all of the time).Total OSDI score was calculated using following formula: OSDI=([sum of scores for all questions answered] × 100)/([total number of questions answered] * 4). Total OSDI score ranged from 0 to 100, with higher scores representing greater disability."|Baseline, Week 12|ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.|||units on a scale||Standard Deviation|Mean
2634080|NCT01817491|Primary|Change in Blood Pressure (BP)||baseline, 4 weeks|Children and parents|||mm Hg||Standard Deviation|Mean
2663346|NCT01553240|Primary|Repetitive Behavior Scale-revised||during screening|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
2634052|NCT01817582|Primary|Percentage of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to Week 13|Safety population included all randomized participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2634053|NCT01817582|Primary|Change From Baseline in Mean Ocular Surface Disease Index (OSDI) Questionnaire Total Score at Week 4|"OSDI is a 12-item questionnaire developed to assess severity of DED. There are 3 question types: Have you experienced any of following (light sensitivity, eye feel gritty, sore eyes, blurred vision, and poor vision) during last week?(items 1-5); Have problems with your eyes limited you in performing any of following (reading, driving at night, working with computer, and watching TV) during last week? (items 6-9); and Have your eyes felt uncomfortable in any of following situations (windy, low humidity, air conditioned) during the last week? (items 10-12). Response of each of these questions were graded on a scale (that relate to the frequency of ocular surface disease effects) of 0 (none of the time) to 4 (all of the time).Total OSDI score was calculated using following formula: OSDI=([sum of scores for all questions answered] × 100)/([total number of questions answered] * 4). Total OSDI score ranged from 0 to 100, with higher scores representing greater disability."|Baseline, Week 4|ITT population included all randomized participants. Missing data was imputed using MMRM method. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2634054|NCT01817582|Primary|Change From Baseline in Corneal Total Fluorescein Staining Score at for the Study Eye at Week 4|Fluorescein Corneal Staining indicates the damage to the corneal epithelium (corneal epitheliopathy). Punctate corneal staining with fluorescein was evaluated and graded according to the National Eye Institute (NEI) grading method. The cornea was divided into 5 regions: central, superior, inferior, nasal and temporal. Each of these 5 regions was graded from scores 0 to 3, where 0 indicated no staining (absent) and 3 maximal staining (severe damage). The total score was the sum of all these regions, ranged from 0 (absence of corneal epitheliopathy) to 15 (severe corneal epitheliopathy).|Baseline (Day 0), Week 4|ITT population included all randomized participants. Missing data was imputed using mixed-effect model for repeated measures (MMRM) method. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2634055|NCT01817491|Secondary|PB/AHA - Adjusted Mean Ratio Insulin||Baseline, 4 weeks|Children and Parents|||ratio||95% Confidence Interval|Mean
2634056|NCT01817491|Secondary|PB/AHA - Adjusted Mean Ratio HgbA1c||Baseline, 4 weeks|Children and Parents|||ratio||95% Confidence Interval|Mean
2634057|NCT01817491|Secondary|PB/AHA - Adjusted Mean Ratio MPO||Baseline, 4 weeks|Children and Parents|||ratio||95% Confidence Interval|Mean
2634058|NCT01817491|Secondary|PB/AHA - Adjusted Mean Ratio IL-6||Baseline, 4 weeks|Children and Parents|||ratio||95% Confidence Interval|Mean
2634059|NCT01817491|Secondary|PB/AHA - Adjusted Mean Ratio Liver Enzymes||Baseline, 4 weeks|Children and Parents|||ratio||95% Confidence Interval|Mean
2634060|NCT01817491|Secondary|PB/AHA - Adjusted Mean Ratio hsCRP||Baseline, 4 weeks|Children and Parents|||ratio||95% Confidence Interval|Mean
2634061|NCT01817491|Secondary|PB/AHA - Adjusted Mean Ratio Glucose||Baseline, 4 weeks|Children and Parents|||ratio||95% Confidence Interval|Mean
2634062|NCT01817491|Secondary|PB/AHA - Adjusted Mean Lipid Profile||Baseline, 4 weeks|Children and parents|||mg/dL||95% Confidence Interval|Mean
2634063|NCT01817491|Secondary|PB/AHA - Adjusted Mean Difference PAQ Children|PAQ self reported questions based on activity level from 1 (low activity) to 5 (high activity), overall PAQ score is a mean of the questions.|Baseline, 4 weeks|Children|||units on a scale||95% Confidence Interval|Mean
2634064|NCT01817491|Secondary|PB/AHA - Adjusted Mean Difference Circumference||Baseline, 4 weeks|Children and Parents|||cm||95% Confidence Interval|Mean
2634065|NCT01817491|Secondary|PB/AHA - Adjusted Mean Difference Weight||Baseline, 4 weeks|Children and Parents|||kg||95% Confidence Interval|Mean
2634066|NCT01817491|Secondary|PB/AHA - Adjusted Mean BP||Baseline, 4 weeks|Children and parents|||ratio||95% Confidence Interval|Mean
2634067|NCT01817491|Secondary|PB/AHA - Adjusted Mean Difference BMI Z Score Children||Baseline, 4 weeks|Children|||Z score||95% Confidence Interval|Mean
2634068|NCT01817491|Secondary|PB/AHA - Adjusted Mean Difference BMI||Baseline, 4 weeks|Children and Parents|||percentile||95% Confidence Interval|Mean
2634069|NCT01817491|Primary|Change in Insulin||baseline, 4 weeks|Children and Parents|||uU/ml||Standard Deviation|Mean
2634070|NCT01817491|Primary|Change in HgbA1c (Hemoglobin A1c)||baseline, 4 weeks|Children and Parents|||percentage||Standard Deviation|Mean
2634071|NCT01817491|Primary|Change in MPO (Myeloperoxidase)||baseline, 4 weeks|Children and Parents|||pmol/L||Standard Deviation|Mean
2634072|NCT01817491|Primary|Change in IL-6 (Interleukin-6)||baseline, 4 weeks|Children and Parents|||pg/ml||Standard Deviation|Mean
2634073|NCT01817491|Primary|Change in Liver Enzymes||baseline, 4 weeks|Children and Parents|||U/L||Standard Deviation|Mean
2634074|NCT01817491|Primary|Change in hsCRP (High-sensitivity C-reactive Protein)||baseline, 4 weeks|Children and Parents|||mg/L||Standard Deviation|Mean
2634075|NCT01817491|Primary|Change in Glucose||baseline, 4 weeks|Children and Parents|||mg/dL||Standard Deviation|Mean
2634076|NCT01817491|Primary|Change in Lipid Profile||baseline, 4 weeks|Children and Parents|||mg/dL||Standard Deviation|Mean
2634077|NCT01817491|Primary|Change in PAQ (Physical Activity Questionnaire)|PAQ self reported questions based on activity level from 1 (low activity) to 5 (high activity), overall PAQ score is a mean of the questions.|baseline, 4 weeks|Children|||units on a scale||Standard Deviation|Mean
2634078|NCT01817491|Primary|Change in Circumference||baseline, 4 weeks|Children and parents|||cm||Standard Deviation|Mean
2634079|NCT01817491|Primary|Change in Weight||baseline, 4 weeks|Children and parents|||kg||Standard Deviation|Mean
2634081|NCT01817491|Primary|Children Change in BMI Z Score|Body mass index z-scores, also called BMI standard deviation (s.d.) scores, are measures of relative weight adjusted for child age and sex. Given a child's age, sex, BMI, and an appropriate reference standard, a BMI z-score (or its equivalent BMI-for-age percentile) can be determined. Negative BMI z-scores indicate a BMI that is lower than the population mean, while positive BMI scores indicate a value that is higher than the population mean. A decrease in the BMI z-score over time indicate a lowering of the BMI. Z-scores of 1.03 and 1.64 correspond to the 85th and 95th percentiles of BMI-for-age, which are the definitions of overweight and obesity in children.|baseline, 4 weeks|Children only|||Z Score||Standard Deviation|Mean
2634082|NCT01817491|Primary|Change in Body Mass Index BMI Percentile||baseline, 4 weeks|Children only|||BMI percentile||Standard Deviation|Mean
2634083|NCT01817374|Secondary|Pathology Residual Tumor|Pathology residual tumor measured in millimeters|6 months||||millimeters||Standard Deviation|Mean
2634084|NCT01817374|Primary|VCEUS Perfusion Time to Peak|Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds.|6 months||||seconds||Standard Deviation|Mean
2634085|NCT01817374|Primary|VCEUS Perfusion Time to Peak|Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds.|Week 4||||seconds||Standard Deviation|Mean
2634086|NCT01817374|Primary|VCEUS Perfusion Time to Peak|Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds.|Week 2||||seconds||Standard Deviation|Mean
2634087|NCT01817374|Primary|Tumor Volume Measure Using Grayscale US|Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.|6 months||||millimeters||Standard Deviation|Mean
2634088|NCT01817374|Primary|Tumor Volume Measure Using Grayscale US|Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.|Week 4||||millimeters||Standard Deviation|Mean
2634089|NCT01817374|Primary|Tumor Volume Measure Using Grayscale US|Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.|Week 2||||millimeters||Standard Deviation|Mean
2634090|NCT01817374|Primary|VCEUS Perfusion Time to Peak|Time of maximal perfusion relative to contrast injection. Range for time to peak intensity is a minimum of 67.5 seconds and a maximum of 99.0 seconds.|Baseline|1 subject did not complete this timepoint due to machine down|||seconds||Standard Deviation|Mean
2634091|NCT01817374|Primary|Tumor Volume Measure Using Grayscale US|Grayscale ultrasound (standard of care) size in millimeters along the longest axis. Range of the grayscale is a minimum of 21.0 millimeters and maximum of 82 millimeters.|Baseline (first visit)||||millimeters||Standard Deviation|Mean
2634092|NCT01817075|Secondary|Rate of Bacteremia Per 1000 At-risk Days|A bacteremia episode is defined any positive blood culture. At risk days are defined as days with eligible central lines in place.|Up to 90 days post enrollment date|3 patients were excluded (2 ineligible and 1 withdrew consent) leaving 174 patients in the analysis.|||bacteremia per 1000 at-risk days||95% Confidence Interval|Number
2634093|NCT01817075|Secondary|Percentage of Patients Who Acquire Cutaneous Bacterial Isolates With Reduced Susceptibility to Chlorhexidine Gluconate (CHG)|Susceptibility to CHG is defined by MIC cutoff that is cutaneous staphylococcal isolate isolated from a follow-up swab with CHG MIC > 4 ug/mL in patient without a resistant staphylococcal isolate isolated from a baseline swab.|Up to 90 days post enrollment date|135 participants contributed a baseline and at least one follow-up swab and were included in this analysis|||percentage of patients|||Number
2634094|NCT01817075|Secondary|Percentage of Patients With Multi-drug Resistant Organisms (MDRO)|MDROs are defined as Staphylococcus aureus resistant to oxacillin, Enterococcus spp. resistant to vancomycin, Klebsiella pneumoniae or Escherichia coli non-susceptible (intermediate or resistant) to ceftriaxone, ceftazidime, cefepime or any carbapenem, and Pseudomonas aeruginosa or Acinetobacter baumannii resistant to any carbapenem or ceftazidime, and either an aminoglycoside or fluoroquinolone. Clostridium difficile infection (CDI) is included as an MDRO and is defined as a positive lab test for C. difficile and > 3 unformed stools in < 24 hours.|Up to 90 days post enrollment date|3 patients were excluded (2 ineligible and 1 withdrew consent) leaving 174 patients in the analyses.|||Percentage of patients|||Number
2634095|NCT01817075|Primary|Central Line-associated Bloodstream Infections (CLABSI) Events During the At-risk Days|Rate of CLABSI per 1000 at-risk days. CLABSI outcome is defined according to the January 2015 Centers for Disease Control and Prevention (CDC) criteria. At risk days are defined as days with eligible central lines in place.|Up to 90 days post enrollment date|3 patients were excluded (2 ineligible and 1 withdrew consent) leaving 174 patients in the analyses.|||CLABSI per 1000 at-risk days.||95% Confidence Interval|Number
2634096|NCT01816906|Other Pre-specified|Vibration Perception Threshold|Average of left and right (8 measurement areas per foot)|Up to 6 months||||V||Standard Deviation|Mean
2634097|NCT01816906|Secondary|Ankle Strength Right 2|Strength during plantar flexion using Citec Dynamometer|Up to 6 months||||N||Standard Deviation|Mean
2634098|NCT01816906|Secondary|Ankle Strength Right 1|Strength during dorsi flexion using Citec Dynamometer|Up to 6 months||||N||Standard Deviation|Mean
2634099|NCT01816906|Secondary|Ankle Strength Left 2|Strength during plantar flexion using Citec Dynamometer|Up to 6 months||||N||Standard Deviation|Mean
2634100|NCT01816906|Secondary|Ankle Strength Left 1|Strength during dorsi flexion using Citec Dynamometer|Up to 6 months||||N||Standard Deviation|Mean
2634101|NCT01816906|Primary|Postural Sway During Shod Standing|"Postural sway was recorded while standing on a pressure mat with eyes open for 30 seconds.~Area of the center of pressure excursion"|6 months||||cm^2||Standard Deviation|Mean
2634102|NCT01816893|Secondary|Catecholamine Response to Lower-body Negative Pressure|Plasma norepinephrine response to lower body negative pressure (at the minus 40 mm Hg data point) on Day 3 about 16 to 20 hours after completion of the euglycemic or hypoglycemic clamp.|16 hours after euglycemic and hypoglycemic clamps|Of the 22 subjects who started the protocol, 20 completed both arms.|||nmol/L||Standard Deviation|Mean
2665175|NCT01536093|Secondary|Time to Reach Full Feeding|day of life when the baby reaches full enteral feeding, defined as a volume above 120~130mL/kg/day|up to 2 months of age|||||||
2634104|NCT01816893|Primary|Change in Baroreflex Sensitivity|The change in baroreflex sensitivity (milliseconds/mm Hg) is calculated as baroreflex sensitivity (milliseconds/mm Hg) on day 3 [assessed 16 hours after the clamp] minus baroreflex sensitivity (milliseconds/mm Hg) on day 1 [baseline assessment on the day prior to the clamp]). Change in baroreflex sensitivity in euglycemic clamp arm is compared to change in baroreflex sensitivity in hypoglycemic arm.|16 hours after euglycemic and hypoglycemic clamps as compared to baseline|20 subjects completed both arms, but only 18 had the change in BRS outcome for both arms.|||ms/mmHg||Standard Deviation|Mean
2634105|NCT01816776|Secondary|Epworth Sleepiness Scale (ESS) Change From Baseline at 6 Months|Change in ESS = Month 6 score - Baseline score. The ESS is an assessment to measure a subject's general level of daytime sleepiness. Scores can range from 0-24, with higher scores indicating higher level of daytime sleepiness.|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt."|||units on a scale||95% Confidence Interval|Mean
2634106|NCT01816776|Secondary|Oxygen Desaturation Index 4% (ODI4) Change From Baseline at 6 Months|Change in ODI4 = Month 6 index - Baseline index. The Oxygen Desaturation Index 4% is a measurement of the number of times per hour of sleep that the blood's oxygen level drops ≥4%.|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt."|||Events/hour||95% Confidence Interval|Mean
2634107|NCT01816776|Secondary|The Proportion of Participants Experiencing a Marked or Moderate Improvement in Patient Global Assessment at 6 Months|"The proportion of subjects with a moderate or marked improvement in the Patient Global Assessment from baseline to the 6 month visit"|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt. Note: 1 Control subject did not provide a response and is excluded from analysis."|||Participants|||Count of Participants
2634108|NCT01816776|Secondary|Rapid Eye Movement (REM) Sleep Change From Baseline at 6 Months|Change in REM = Month 6 percentage - Baseline percentage. Rapid Eye Movement (REM) is a sleep stage. A higher percentage of sleep in REM is a measure of better sleep quality.|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt."|||percentage of sleep||95% Confidence Interval|Mean
2634109|NCT01816776|Secondary|Arousal Index (ArI) Change From Baseline at 6 Months|Change in ArI = Month 6 index - Baseline index. The Arousal Index is a measurement used to indicate the number of times per hour of sleep that sleep is disrupted.|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt."|||Events/hour||95% Confidence Interval|Mean
2634110|NCT01816776|Secondary|Apnea-Hypopnea Index (AHI) Change From Baseline at 6 Months|Change in AHI = Month 6 index - Baseline index. The Apnea-Hypopnea Index is a measurement used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month PSG results or had unsuccessful implant attempt."|||Events/hour||95% Confidence Interval|Mean
2634111|NCT01816776|Secondary|Central Apnea Index (CAI) Change From Baseline at 6 Months|Change in CAI = Month 6 index - Baseline index. The central apnea index is a measurement used to indicate the severity of central sleep apnea. It is represented by the number of central apnea events per hour of sleep.|6 months|"Per protocol: excludes patients who did not meet major entry criteria, had therapy programmed to off at the 6-month visit, did not have 6-month polysomnogram (PSG) results or had unsuccessful implant attempt."|||Events/hour||95% Confidence Interval|Mean
2634112|NCT01816776|Primary|Freedom From Related Serious Adverse Events Within 12 Months|Freedom from serious adverse events (SAEs) associated with the implant procedure, the remede System, or the delivered therapy at 12 months post therapy initiation visit.|12 months|Intent-to-treat. The study protocol pre-specified that randomized groups be combined to assess freedom from related serious adverse events within 12 months.|||Participants|||Count of Participants
2634113|NCT01816776|Primary|The Proportion of Participants Experiencing a Reduction in Apnea-hypopnea Index (AHI)|Comparison of the proportion of subjects in the Treatment group achieving a 50% or greater reduction in AHI from baseline to 6 months compared to the Control group.|6 months|The population analyzed included all randomized participants who had a 6 month assessment. In addition, Treatment group subjects who did not have a 6 month assessment for reasons related to implant, device or delivered therapy were included as not achieving the endpoint.|||Participants|||Count of Participants
2634114|NCT01816763|Secondary|Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (DVPRS) Number of Participants Who Rated Overall Functional Status Worse Relative to Peers Using the Gill Single Item Questionnaire|"descriptive analysis comparing overall pain rated by the three measures at Baseline (NRS, PEG, DVPRS), two of which include function (PEG and DVPRS), using the outcome of pre-specified single item of self-reported function compared to one's peers as validated by Gill et. al.. All pain outcome measures (NRS, PEG, DVPRS) are described fully in Outcome 1. Gill single item is not otherwise formally named. It is a 3 item scale querying self rated activity level relative to peers where the categories include less active, about as active, and more active and is scored as a categorical 0-2 rating where 2 is optimal and 0 is worst relative function."|Baseline cross-sectional comparison at time of clinic visit||||participants|||Number
2634115|NCT01816763|Secondary|Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (DVPRS) Differences in Number of Individuals Who Failed to Complete Pain Screen|Number of persons who failed to complete (NRS and PEG and DVPRS measures). the measures vary in complexity as the NRS is one item, the PEG 3 items, and the DVPRS includes 10 items integrating color, faces pain, function, and intensity descriptions of pain. Measures are fully described in Outcome 1 description.|Baseline cross sectional comparison at the time of clinic visit||||participants|||Number
2634162|NCT01816061|Primary|Change From Baseline in Frontal Systems Behavior Scale at 2 Months|Change from Baseline in Frontal Systems Behavior Scale (FrSBe) at 2 months. Minimum value =21, Maximum value=158, Higher score correlates with worse outcome.|Baseline and 2 months||||score on a scale||Standard Deviation|Median
2665176|NCT01536093|Secondary|Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines||2 weeks of age|||||||
2634116|NCT01816763|Primary|Arm 1 (NRS Now), to Arm 2 (PEG), to Arm 3 (Defense Veterans Pain Rating Scale (e.g.,DVPRS) Differences Baseline Overall Pain Compared With Gold Standard Chronic Pain Grade Questionnaire Intensity Subscale Items (e.g., CPG Scale, Pain Intensity)|pain (Numeric Rating Scale - NRS and PEG (full scale name) and Defense Veterans Pain Rating Scale - DVPRS measures) using overall pain derived from each of the three measures compared cross sectionally with the three pain intensity items and scale of the Chronic Pain Grade (CPG) questionnaire. The latter addresses pain 'now', average pain, and worst pain. All measures (NRS, PEG, DVPRS, and CPG) are scored from 0-10 where 0 equals no pain and 10 equals worst possible pain.). the NRS is a one item pain intensity measure, the PEG is a 3 item measure combining pain intensity, pain-related emotional and functional interference, and the DVPRS integrates pain intensity, pain interference, faces pain, and colormetric indicators on a 0-10 overall pain scale. The study used no subscales for the NRS, PEG, or DVPRS, and all values reported are total measure scores, computed as the average of items. We compare them to the pain intensity score of the CPG. Higher scores signify worse pain.|Baseline (e.g., time of clinic visit) measures were cross sectionally assessed||||units on a scale||Standard Deviation|Mean
2634117|NCT01816685|Primary|Presence of Postoperative Delirium|Assessments for delirium were made on postoperative day 2 using the Confusion Assessment Method (CAM) Diagnostic Algorithm. This binary tool identifies the presence or absence of delirium|Postoperative day 2||||participants|||Number
2634118|NCT01816685|Primary|Presence of Postoperative Delirium|Assessments for delirium were made on postoperative day 2 using the Delirium Rating Scale-Revised-98 (DRS-R-98) diagnostic and assessment tool. The DRS-R-98 is a 16-item clinician-rated scale that consists of a severity score (maximum score 39, minimum 0) made up of items that can be used for repeated serial measurements and a total scale score (maximum score 46, minimum 0) that includes the severity score plus three diagnostic items (7 additional possible points) used for initial ratings. Items represent symptoms that are rated on a scale of 0 to 3 points, with text descriptions for each point. Higher scores on the scale represents a larger number of delirium symptoms or increased severity of those symptoms.|Postoperative day 2||||units on a scale||Standard Deviation|Mean
2634119|NCT01816594|Secondary|Percentage of Participants With Node-negative Disease at Definitive Surgery (ypN0)|Node-negative disease at definitive surgery (ypN0) were considered as binary variables of 'response' versus 'non response'.|18 weeks|Intent-to-treat set (ITT)/full analysis set (FAS) (pooled): The full analysis set comprised all patients to whom study treatment had been assigned by randomization. Patients who were randomized but did not start study treatment were not replaced and were considered as treatment failures similarly to other patients with no pCR assessment.|||Percentage of participants||95% Confidence Interval|Number
2634120|NCT01816594|Secondary|Percentage of Participants With Remaining Ductal Carcinoma in Situ (DCIS) (ypTis)|This included participants at definitive surgery irrespective of lymph node status|18 weeks|Intent-to-treat set (ITT)/full analysis set (FAS) (pooled): The full analysis set comprised all patients to whom study treatment had been assigned by randomization. Patients who were randomized but did not start study treatment were not replaced and were considered as treatment failures similarly to other patients with no pCR assessment.|||Percentage of participants||95% Confidence Interval|Number
2634121|NCT01816594|Secondary|Percentage of Participants With Objective Response Rates by Hormone Receptor Status - Negative Estrogen Receptor (ER-)|Objective response rate = Complete Response + Partial Response rate, measured by US bidimentional ulltrasound (or MRI) and assessed by world health organization (WHO) criteria. CR: Complete disappearance of all tumor signs in the breast as assessed by ultrasound or MRI. The response of the axillary nodes was not to be considered. PR: Reduction in the product of the two largest perpendicular diameters of the primary tumor size by 50% or more assessed by ultrasound or MRI. In patients with multifocal or multicentric disease, the lesion with the largest diameters should be chosen for follow-up. The response of the axillary nodes was not to be considered.|After Week 6|Intent-to-treat set (ITT)/full analysis set (FAS) (pooled): The full analysis set comprised all patients to whom study treatment had been assigned by randomization. Patients who were randomized but did not start study treatment were not replaced and were considered as treatment failures similarly to other patients with no pCR assessment.|||Percentage of participants||95% Confidence Interval|Number
2634122|NCT01816594|Secondary|Percentage of Participants With Objective Response Rates by Hormone Receptor Status - Positive Estrogen Receptor (ER+)|Objective response rate = Complete Response + Partial Response rate, measured by US bidimentional ulltrasound (or MRI) and assessed by world health organization (WHO) criteria. CR: Complete disappearance of all tumor signs in the breast as assessed by ultrasound or MRI. The response of the axillary nodes was not to be considered. PR: Reduction in the product of the two largest perpendicular diameters of the primary tumor size by 50% or more assessed by ultrasound or MRI. In patients with multifocal or multicentric disease, the lesion with the largest diameters should be chosen for follow-up. The response of the axillary nodes was not to be considered.|After Week 6|Intent-to-treat set (ITT)/full analysis set (FAS) (pooled): The full analysis set comprised all patients to whom study treatment had been assigned by randomization. Patients who were randomized but did not start study treatment were not replaced and were considered as treatment failures similarly to other patients with no pCR assessment.|||Percentage of participants||95% Confidence Interval|Number
2634123|NCT01816594|Secondary|Percentage of Participants With pCR Rates by Hormone Receptor Status Negative Estrogen Receptor (ER-)|pCR defined as no invasive and non-invasive (DCIS) residuals in breast and lymph nodes (ypT0, ypN0 [GBG definition]); pCR defined as no invasive residuals in breast and lymph nodes (ypT0/Tis, ypN0 [MD Anderson definition]). If participant had a sentinel node biopsy before treatment which was negative and no axilla dissection was performed after treatment completion, such participant was considered to be pN0 for both secondary pCR definitions.|After Week 6|Intent-to-treat set (ITT)/full analysis set (FAS) (pooled): The full analysis set comprised all patients to whom study treatment had been assigned by randomization. Patients who were randomized but did not start study treatment were not replaced and were considered as treatment failures similarly to other patients with no pCR assessment.|||Percentage of participants||95% Confidence Interval|Number
2634163|NCT01816061|Primary|Change From Baseline in Community Reintegration for Injured Service Members at 2 Months|Change from Baseline in Community Reintegration for Injured Service Members (CRIS) at 2 months. The investigators used in the report CRIS subscale - Extent of Participation, CRIS with the score range 28.0-64.0. Higher scores mean a better outcome for the Extent of Participation, Community Reintegration for Injured Service Members (CRIS)|Baseline and 2 months||||score on a scale||Standard Deviation|Mean
2634124|NCT01816594|Secondary|Percentage of Participants With pCR Rates by Hormone Receptor Status - Positive Estrogen Receptor (ER+)|pCR defined as no invasive and non-invasive (DCIS) residuals in breast and lymph nodes (ypT0, ypN0 [GBG definition]); pCR defined as no invasive residuals in breast and lymph nodes (ypT0/Tis, ypN0 [MD Anderson definition]). If participant had a sentinel node biopsy before treatment which was negative and no axilla dissection was performed after treatment completion, such participant was considered to be pN0 for both secondary pCR definitions.|After Week 6|Intent-to-treat set (ITT)/full analysis set (FAS) (pooled): The full analysis set comprised all patients to whom study treatment had been assigned by randomization. Patients who were randomized but did not start study treatment were not replaced and were considered as treatment failures similarly to other patients with no pCR assessment.|||Percentage of participants||95% Confidence Interval|Number
2634125|NCT01816594|Secondary|Overall Objective Response Rate (ORR) Prior to Surgery for All Participants|Number of Overall objective response rate = Complete Response + Partial Response rate, measured by US bidimentional ulltrasound (or MRI) and assessed by world health organization (WHO) criteria. CR: Complete disappearance of all tumor signs in the breast as assessed by ultrasound or MRI. The response of the axillary nodes was not to be considered. PR: Reduction in the product of the two largest perpendicular diameters of the primary tumor size by 50% or more assessed by ultrasound or MRI. In patients with multifocal or multicentric disease, the lesion with the largest diameters should be chosen for follow-up. The response of the axillary nodes was not to be considered.|prior to surgery|Intent-to-treat set (ITT)/full analysis set (FAS) (pooled): The full analysis set comprised all patients to whom study treatment had been assigned by randomization. Patients who were randomized but did not start study treatment were not replaced and were considered as treatment failures similarly to other patients with no pCR assessment.|||Percentage of participants||95% Confidence Interval|Number
2634126|NCT01816594|Secondary|Percentage of Participants With No Invasive and Non-invasive (DCIS) Residuals in Breast and Lymph Nodes Per MD Anderson Definition|Rate of pCR defined as no invasive residuals in breast and lymph nodes (ypT0/Tis, ypN0 [MD Anderson definition]). If a patient had a sentinel node biopsy before treatment which was negative and no axilla dissection was performed after treatment completion, such patient was considered to be pN0 for both secondary pCR definitions.|After Week 6|Intent-to-treat set (ITT)/full analysis set (FAS) (pooled): The full analysis set comprised all patients to whom study treatment had been assigned by randomization. Patients who were randomized but did not start study treatment were not replaced and were considered as treatment failures similarly to other patients with no pCR assessment.|||Percentage of participants||95% Confidence Interval|Number
2634127|NCT01816594|Secondary|Percentage of Participants With No Invasive and Non-invasive (DCIS) Residuals in Breast and Lymph Nodes Per GBG Definition|Rate of pCR defined as no invasive and non-invasive (DCIS) residuals in breast and lymph nodes (ypT0, ypN0 [GBG definition]). If patient had a sentinel node biopsy before treatment which was negative and no axilla dissection was performed after treatment completion, such patient was considered to be pN0 for both secondary pCR definitions. Surgical breast and axillary node resection specimens were evaluated for pathologic tumor response according to NSABP guidelines.|After Week 6|Intent-to-treat set (ITT)/full analysis set (FAS) (pooled): The full analysis set comprised all patients to whom study treatment had been assigned by randomization. Patients who were randomized but did not start study treatment were not replaced and were considered as treatment failures similarly to other patients with no pCR assessment.|||Percentage of participants||95% Confidence Interval|Number
2634128|NCT01816594|Secondary|Rate of Breast Conserving Surgery (Most Radical Surgery)|Rate of patients with breast conserving surgery. Participants who did not have breast surgery were also considered as having breast conservation surgery (BCS)|18 weeks|Intent-to-treat set (ITT)/full analysis set (FAS) (pooled): The full analysis set comprised all patients to whom study treatment had been assigned by randomization. Patients who were randomized but did not start study treatment were not replaced and were considered as treatment failures similarly to other patients with no pCR assessment.|||Percentage of participants||95% Confidence Interval|Number
2634129|NCT01816594|Secondary|Overall Objective Clinical Response Rate at the End of the Biologic Window (After Week 6) Compared to Baseline (Key Secondary) - PIK3A Mutant Participants|Percentage of Overall objective clinical response rate = Complete Response + Partial Response rate, measured by US bidimentional ulltrasound (or MRI) and assessed by world health organization (WHO) criteria.|After week 6|Intent-to-treat set (ITT)/full analysis set (FAS) (pooled): The full analysis set comprised all patients to whom study treatment had been assigned by randomization. Patients who were randomized but did not start study treatment were not replaced and were considered as treatment failures similarly to other patients with no pCR assessment.|||Percentage of participants||95% Confidence Interval|Number
2634130|NCT01816594|Secondary|Overall Objective Clinical Response Rate at the End of the Biologic Window (After Week 6) Compared to Baseline (Key Secondary) - PIK3A Wild Type Participants|Percentage of Overall objective clinical response rate = Complete Response + Partial Response rate, measured by US bidimentional ulltrasound (or MRI) and assessed by world health organization (WHO) criteria.|After week 6|Intent-to-treat set (ITT)/full analysis set (FAS) (pooled): The full analysis set comprised all patients to whom study treatment had been assigned by randomization. Patients who were randomized but did not start study treatment were not replaced and were considered as treatment failures similarly to other patients with no pCR assessment.|||Percentage of participants||95% Confidence Interval|Number
2634131|NCT01816594|Secondary|Overall Objective Clinical Response Rate at the End of the Biologic Window (After Week 6) Compared to Baseline (Key Secondary) - All Participants|Percentage of Overall objective clinical response rate = Complete Response + Partial Response rate, measured by US bidimentional ulltrasound (or MRI) and assessed by world health organization (WHO) criteria.|After week 6|Intent-to-treat set (ITT)/full analysis set (FAS) (pooled): The full analysis set comprised all patients to whom study treatment had been assigned by randomization. Patients who were randomized but did not start study treatment were not replaced and were considered as treatment failures similarly to other patients with no pCR assessment.|||Percentage of participants||95% Confidence Interval|Number
2634164|NCT01816048|Primary|Number of Participants With a Change in Total NaF PET/CT Standardized Uptake Values|To measure changes in NaF PET/CT standardized uptake values (SUV total) from prior to dosing with Tak-700 to12 weeks after starting treatment with TAK-700. Percent change from three months to baseline; value at three months minus value at baseline.|Baseline and 3 months|The study closed early so only 8 of 20 planned were enrolled and of the 8, only 4 completed the week 12 scan.|||Participants|||Count of Participants
2634132|NCT01816594|Primary|Pathological Complete Response (pCR) Rate at the Time of Surgery - PIK3CA Mutant (MT)|Rate of pCR (as defined by NSABP criteria - absence of invasive disease in the breast [ypT0]) is the number of of participants with pathological complete response (pCR) at the time of surgery. Participants were to be considered in pCR if there was no invasive cancer in the breast or only non-invasive in situ cancer in the breast specimen. NSABP guidelines do not take into account the histological nodal status to define the pCR.|After 6 weeks|Intent-to-treat set (ITT)/full analysis set (FAS) (pooled): The full analysis set comprised all patients to whom study treatment had been assigned by randomization. Patients who were randomized but did not start study treatment were not replaced and were considered as treatment failures similarly to other patients with no pCR assessment.|||Percentage of participants||95% Confidence Interval|Number
2634133|NCT01816594|Primary|Pathological Complete Response (pCR) Rate at the Time of Surgery - PIK3CA Wild Type (WT)|Rate of pCR (as defined by NSABP criteria - absence of invasive disease in the breast [ypT0]) is the number of of participants with pathological complete response (pCR) at the time of surgery. Participants were to be considered in pCR if there was no invasive cancer in the breast or only non-invasive in situ cancer in the breast specimen. NSABP guidelines do not take into account the histological nodal status to define the pCR.|After 6 weeks|Intent-to-treat set (ITT)/full analysis set (FAS) (pooled): The full analysis set comprised all patients to whom study treatment had been assigned by randomization. Patients who were randomized but did not start study treatment were not replaced and were considered as treatment failures similarly to other patients with no pCR assessment.|||Percentage of participants||95% Confidence Interval|Number
2634134|NCT01816594|Primary|Pathological Complete Response (pCR) Rate at the Time of Surgery - All Participants|Rate of pCR (as defined by NSABP criteria - absence of invasive disease in the breast [ypT0]) is the number of of participants with pathological complete response (pCR) at the time of surgery. Participants were to be considered in pCR if there was no invasive cancer in the breast or only non-invasive in situ cancer in the breast specimen. NSABP guidelines do not take into account the histological nodal status to define the pCR.|After 6 weeks|Intent-to-treat set (ITT)/full analysis set (FAS) (pooled): The full analysis set comprised all patients to whom study treatment had been assigned by randomization. Patients who were randomized but did not start study treatment were not replaced and were considered as treatment failures similarly to other patients with no pCR assessment.|||Percentage of participants||95% Confidence Interval|Number
2634135|NCT01816477|Secondary|Mean Daily Pain Score|Pain was measured by a visual analogue scale (VAS) with pre-set markings from 0 to 10, with 0 for no pain to 10 for the worst possible pain. On the case report form each day had 6 time categories: waking up in the morning, around lunch time, afternoon approximately 3-4 pm, dinner time, bedtime, and during the night time. Each day was averaged for each subject, then the values for each arm were averaged.|Days 1-7 post operation|The numbers of participants analyzed varied each day. The numbers per arm analyzed per day category are expressed in the table as (n=Thoracic epidural, ON-Q).|||units on a scale||Standard Deviation|Mean
2634136|NCT01816477|Primary|Use of Analgesic Narcotic|Postoperative analgesic used each day over 7 day postoperative period.|1-7 days post operation|The numbers of participants analyzed varied each day. The numbers per arm analyzed per day category are expressed in the table as (n=Thoracic epidural, ON-Q). The protocol had planned to use the area under the curve, but this was not analyzed in the published paper, due to the presence of missing data in the analgesic narcotic measurements.|||morphine milligram equivalents||Standard Deviation|Mean
2634137|NCT01816477|Primary|Hospital Length of Stay|Hospital length of stay was measured from the day of surgery (day 0) through postoperative day 11.|Up to 11 days post operation||||days||Standard Deviation|Mean
2634138|NCT01816451|Primary|Fat Mass (%)|The subjects underwent a set of anthropometric assessments, which followed the norms of the International Society for Advancement of Kinanthropometry. The fat mass was calculated by percentage using the equation proposed by Jackson and Pollock (1978) from seven skinfold measurement. To measure the skinfolds, a Sanny Professional Skinfold Caliper was used.|Pre and post 14 weeks/46 sessions of training||||Fat Mass %||Standard Deviation|Mean
2634139|NCT01816451|Primary|Rate of Perceived Exertion (RPE) on Maximal Test|"The RPE was collected at maximal test (see description of test on outcome measure Maximal Oxygen Uptake). Relative to overall feelings were collected by Category Ratio Scale (CR10) during the last 15 s of each stage using the Borg category (0 - 10) scale. Instructions for RPE were that 0 corresponds to rest, and 9 - 10 corresponds to maximal exertion. This verbal procedure was explained before initiating exercise."|Pre and post 14 weeks/46 sessions of training||||units on a scale||Standard Deviation|Mean
2634140|NCT01816451|Primary|Body Mass (BM)|To measure body mass Filizola scales with a stadiometer was used.|Body Mass was collected pre and post training||||kg||Standard Deviation|Mean
2634141|NCT01816451|Primary|Blood Lactate Concentrations on Maximal Test|Capillary blood samples (25 µl) were obtained from the finger of each subject during all tests and the [La] were measured using an (Accutrend®Plus Roche Diagnostics Gesellschaft mit beschränkter Haftung , Mannheim, Germany). The measuring range was 0.8-22 millimole (mM). The sample is collecting (Accu-Chek® Softclix) and first applied to a coded yellow test strip (Accutrend Blood measure-Roche) with a reagent chemical substance. Blood was added to the strip by letting it drip from a finger; in accordance with the instrument's instructions. The finger never touched the strip's pad in order to exclude any possible interference due to the sweat. All [La] were collected by a single, experienced investigator.|Pre and post 14 weeks/46sessions on rest (5 min sitting position; before start the test); 1-3-5 min immediately after the end of the test (on sitting position).||||mmol*L^-1||Standard Deviation|Mean
2634142|NCT01816451|Secondary|Rate of Perceived Exertion (RPE) on Submaximal Test|"The RPE was collected at submaximal test (see description of test on outcome measure HR at submaximal test). Relative to overall feelings were collected by Category Ratio Scale (CR10) during the last 15 s of each stage using the Borg category (0 - 10) scale. Instructions for RPE were that 0 corresponds to rest, and 9 - 10 corresponds to maximal exertion. This verbal procedure was explained before initiating exercise."|Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46sessions training|The control group didn't do the submaximal test because it was done only for determine and adjusted the training intensities.|||units on a scale||Standard Deviation|Mean
2634165|NCT01816048|Secondary|PSA Response Rate and Circulating Tumor Cell Counts of Subjects Receiving TAK700 to NaF PET/CT Imaging Results||Baseline, one month, 2 months, 3 months|Data was not collected for this outcome measure.||||||
2634143|NCT01816451|Secondary|Submaximal Velocity [Vsub]|Submaximal tests were done at the same treadmill (Treadmill® TR9100HR, Life Fitness, USA) as training.Before the test, all subjects should be able to do it at moderate-high intensity. The test began with three minutes of progressive warm-up. During the first minute, the subject maintains a light level; during the second and third minutes of the warm-up, the intensity was moderate. Starting from the fourth minute, the subject should be able to maintain a velocity for the next seven to ten minutes. This load can be adjusted as required, through verbal communication between the subject and the evaluator. The test finishes at the end of 10 minutes. The test velocity should be clearly constant at the end of the test. Values of velocity were monitored and recorded at the end of each minute, e.g. 10 seconds before ending each measured minute, and the last measurement were at the end of the 10 minutes. The objective of this procedure was to identify the value of that speed has stabilized.|Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46sessions of training|The control group didn't do the submaximal test because it was done to determine and adjusted the HR training intensities and also collected [Vsub] during submaximal effort.|||km/h||Standard Deviation|Mean
2634144|NCT01816451|Secondary|Blood Lactate on Submaximal Test|Capillary blood samples (25 µl) were obtained from the finger of each subject during all tests and the [La] were measured using an (Accutrend®Plus Roche Diagnostics Gesellschaft mit beschränkter Haftung , Mannheim, Germany). The measuring range was 0.8-22 mM. The sample is collecting (Accu-Chek® Softclix) and first applied to a coded yellow test strip (Accutrend Blood Measure-Roche) with a reagent chemical substance. Blood was added to the strip by letting it drip from a finger; in accordance with the instrument's instructions we never let the finger touch the strip's pad in order to exclude any possible interference due to the sweat.|Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46 sessions training: rest (5-min sitting; before start the test); 1-3-5 minutes immediately after the end of the test (on sitting position).|The control group didn't do the submaximal test because it was done to determine and adjusted the HR training intensities and also collected [La] on rest and after submaximal effort during 14 weeks of training.|||mmol*L^-1||Standard Deviation|Mean
2634145|NCT01816451|Secondary|Heart Rate on Submaximal Test|Submaximal tests were done at the same treadmill (Treadmill® TR9100HR, Life Fitness, USA) as training.Before the test, all subjects should be able to do it at moderate-high intensity. The test began with three minutes of progressive warm-up. During the first minute, the subject maintains a light level; during the second and third minutes of the warm-up, the intensity was moderate. Starting from the fourth minute, the subject should be able to maintain a velocity for the next seven to ten minutes. This load can be adjusted as required, through verbal communication between the subject and the evaluator. The test finishes at the end of 10 minutes.The test velocity should be clearly constant at the end of the test. Heart rate were monitored and recorded at the end of each minute, e.g. 10 seconds before ending each measured minute, and the last measurement were at the end of the 10 minutes. The objective of this procedure was to identify the HR values for training intensities.|Pre; during (retest I 0-6weeks; retest II 0-10 weeks) and post 14 weeks/46sessions training: rest (5-min sitting; before start the test); maximal during the test (maxHRsub); 60s-120s immediately after the end of the test (on sitting position).|The control group didn't do the submaximal test because it was done to determine and adjusted the training intensities during the 14 weeks.|||bpm||Standard Deviation|Mean
2634146|NCT01816451|Primary|Heart Rate on Maximal Test|The HR was collected pre and post training on maximal VO2 test. Initially, with the individual on the treadmill (Inbrasport Master Super, Porto Alegre, Brazil), electrodes (Micromed) were placed at the manubrium, right and left iliac crest for measured heart rate (HR) (derivation CM5) and were connected to an electromyography equipment (Micromed®). HR values were visualized through Elite software (Micromed Biotechnology, Brasilia, Brazil).|Pre and post 14 weeks at rest (5 min sitting; before start the test), during the test (to determine max), and 60s and 120s immediately after the end of the test (on sitting position)||||bpm||Standard Deviation|Mean
2634147|NCT01816451|Primary|Total Time Reaching on Maximal Test (tVO2max)|The criterion for determining the total time reaching in maximal VO2 test was associated with the time immediately preceding heart rate shown a reduction of five or more beats.|Pre and post 14 weeks/46 sessions of training||||minutes||Standard Deviation|Mean
2634148|NCT01816451|Primary|Absolute Maximal Oxygen Uptake|The absolute maximal oxygen uptake was taken by individual connected to a metabolic gas analyzer (VO-2000, Aerosport, Medgraphics, St. Paul, Minnesota) through which the gas samples were collected and measured each 10 seconds during the test. The participants were submitted to a ramp protocol with an initial velocity of 8.0 km/h (0% of inclination), progressive increments, a final velocity of 18 km/h (2% de inclination). The duration was equal to 10 minutes or until voluntary exhaustion.|Pre and post 14 weeks||||L/min||Standard Deviation|Mean
2634149|NCT01816451|Primary|Relative Maximal Oxygen Uptake|The relative maximal oxygen uptake was taken by individual connected to a metabolic gas analyzer (VO-2000, Aerosport, Medgraphics, St. Paul, Minnesota) through which the gas samples were collected and measured each 10 seconds during the test. The participants were submitted to a ramp protocol with an initial velocity of 8.0 km/h (0% of inclination), progressive increments, a final velocity of 18 km/h (2% de inclination). The duration was equal to 10 minutes or until voluntary exhaustion.|Pre and post 14 weeks||||mL/(kg*min)||Standard Deviation|Mean
2634150|NCT01816295|Secondary|Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)||Double Blind Baseline, Week 12, Open Label Baseline, Week 36|All participants with non-missing PSA result at the specified time point.|||participants|||Number
2634151|NCT01816295|Other Pre-specified|Change From Baseline in Total International Prostate Symptom Score (IPSS)|The IPSS is a self-administered instrument used to assess for the severity of lower urinary tract symptoms. The IPSS consists of 7 questions that were scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates.|Baseline, Week 12, Week 36|All randomized participants with non-missing baseline IPSS measurement and at least one non-missing post baseline IPSS measurement. Missing data endpoints were imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
2634196|NCT01815671|Secondary|Pain Related or Possibly Related to Colonoscopy Procedure|Visual Analogue Scale measured 0-4 with zero being no pain and 4 being most severe pain.|24 hours||||units on a scale||Standard Deviation|Mean
2634197|NCT01815671|Secondary|Time to Full Colonoscope Insertion||30 minutes||||minutes||Standard Deviation|Mean
2634152|NCT01816295|Secondary|Change From Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores|"The HED is a self-administered instrument used to assess real-time energy levels in men with symptomatic hypogonadism. It consists of 2 questions that were scored on a scale from 0 to 10, with 10 corresponding to Full of Energy or Not Tired at All (The Tiredness scale was reverse-mapped, as it was collected with 10 corresponding to Extreme Tiredness). The questionnaire was completed 3 times daily (forming 6 unique items) for 7 consecutive days. Item scores were computed by averaging the values for each item across 7 days. If more than 2 days were missing for an item, the item score was missing. The total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater energy. If any item score was missing, the total score was missing. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates."|Baseline, Week 12|Randomized participants who reported low energy at baseline with non-missing HED questionnaire at baseline and at least one post baseline visit. Missing data endpoints were imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
2634153|NCT01816295|Secondary|Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores|"The SAID Scale is a self-administered instrument used to assess sexual arousal, interest, and sex drive in men with symptomatic hypogonadism. The SAID consists of 5 questions that were scored on a scale from 1 to 5, with 5 corresponding to greater levels of sexual arousal, interest, or drive. The SAID Scale total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater sexual arousal, interest, and drive. Least squares (LS) mean change from baseline was calculated using an analysis of covariance (ANCOVA) with treatment group and the baseline value as covariates."|Baseline, Week 12|Randomized participants who reported low sex drive at baseline with non-missing SAID Scale data at baseline and at least one post baseline visit. Missing data endpoints were imputed using last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2634154|NCT01816295|Primary|Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12|Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL).|Week 12|All randomized participants who completed 12 weeks of treatment and had non-missing testosterone concentration at week 12.|||participants|||Number
2634155|NCT01816243|Secondary|Number of Participants With Participant's Global Assessment|Participants global assessment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100% worse, 0=unchanged and 4=100% improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=mild, 3=moderate, 4=severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent). Number of participants with participant's global assessment with respect to efficacy, safety and overall satisfaction were reported.|Day 30|The ITT population set included all participants who received at least one dose of study drug and had at least one post-baseline efficacy assessment. 'N' (number of participants analyzed) = participants who were evaluable for this measure and 'n' = participants who were evaluable for this measure at given time points.|||Participants|||Number
2634156|NCT01816243|Secondary|Number of Participants With Investigator's Global Assessment|Investigator would complete a global assessment of the participants treatment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent (%) worse, 0=unchanged and 4=100% improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=mild, 3=moderate, 4=severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent). Number of participants with Investigator's assessment with respect to efficacy, safety and overall satisfaction were reported.|Day 30|The ITT population set included all participants who received at least one dose of study medication and who had at least one post-baseline efficacy assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Participants|||Number
2634157|NCT01816243|Primary|Change From Baseline in Pain Intensity Rating at Day 30|Pain intensity was assessed on 11-point NRS; score ranges from 0 to 10 where 0=no pain and 10=worst pain.|Baseline and Day 30|The ITT population set included all participants who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2634158|NCT01816243|Primary|Change From Baseline in Pain Intensity Rating at Day 15|Pain intensity was assessed on 11-point Numeric Rating Scale (NRS); score ranges from 0 to 10 where 0=no pain and 10=worst pain.|Baseline and Day 15|Intent-to-treat (ITT) population set included all participants who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2634159|NCT01816074|Other Pre-specified|Parental and Family Functioning|The Dyadic Parent-Child Interaction Coding System (DPICS) will be used at baseline, week 8, and week 16 to provide an observational measure of positive and negative behaviors of the mother toward the child. Instances of positive (e.g. praise) and negative (e.g. criticism) behaviors are coded by study raters trained to reliability; scores range from 0 to no upper limit. Higher numbers indicate higher instances of the observed behaviors.|Baseline, Weeks 8 and 16|6 participants were in the study before this assessment was added. 2 participants did not complete this assessment before they withdrew from the study. 3 participants withdrew from the study after the baseline visit (1 in the medication then medication arm after week 8, 1 in the Medication then BPT arm and 1 in BPT then BPT arm).|||instances observed||Standard Deviation|Mean
2634160|NCT01816074|Secondary|Maternal Behavioral Functioning|The Clinical Global Impression - Severity (CGI-S) scale will be used. This was collected at Baseline, Week 8 (end of Phase 1) and Week 16 (end of Phase 2). The CGI-S scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse.|Baseline, Weeks 8 and 16||||units on a scale||Standard Deviation|Mean
2634161|NCT01816074|Primary|Child Behavioral Functioning|Child symptom severity will be assessed using the Clinical Global Impression - Severity (CGI-s) scale. This was collected at Baseline, Week 8 (end of Phase 1) and Week 16 (end of Phase 2). The CGI-S scale summarizes the clinician's impression of the participant's symptom improvement and ranges from 1-7 with 1 representing very much improved and 7 representing very much worse.|Baseline, Weeks 8 and 16|7 participants had missing data, the Child CGI-S was not collected at any of the study visits for these participants because they completed the study before this measure was added to the protocol.|||units on a scale||Standard Deviation|Mean
2634166|NCT01816048|Secondary|Number of Participants With Change in the Number of Circulating Tumor Cells Using the Cell Search System (Veridex, LLC) Obtained Prior to Beginning Treatment With TAK 700, After Completing One Cycle and After Completing 3 Cycles|Change from baseline to one month and three month.|At baseline, one month, three months|Due to study closing early only 8 of planned 20 enrolled. All subjects completed one month of treatment; only 4 subjects completed the week 12 scan.|||Participants|||Count of Participants
2634167|NCT01816048|Secondary|Number of Participants With a Change in the Number of Circulating Tumor Cells Using One or More Methods (Epispot)|Baseline compared to 12 weeks. Value at three months minus value at baseline.|At baseline and 12 weeks|Due to study closing early only 8 of 12 patients enrolled, and only 5 subjects obtained a week 12 CTC test.|||Participants|||Count of Participants
2634168|NCT01816048|Secondary|Compare Changes on NaF PET/CT After Treatment With TAK700 With Standard Clinical Outcomes Including PSA Doubling Time, Response Evaluation Criteria in Solid Tumors (RECIST), and Radiographic Progression Free Survival.||Approximately 24 months|Due to study closing early, only 8 of planned 20 patients enrolled. Data for this endpoint was not obtained.||||||
2634169|NCT01816048|Secondary|Number of Participants With Changes in NaF PET/CT Results in Response to TAK700|This is an exploratory endpoint as we are planning to identify other new parameters during the PET/CT scanning that may be more predictive of response (such as SUV volume, or dynamic changes during the scanning period). Changes in results at week 12 compared to baseline. Value at 12 weeks minus value at baseline.|At baseline and 12 weeks|Due to study closing early only 8 of planned 20 patients enrolled and only 4 of the 8 subjects enrolled completed the week 12 scan.|||Participants|||Count of Participants
2634170|NCT01816048|Secondary|Number of Patients With a Measurable Change in PSA Kinetics With TAK700 From Baseline to Off Treatment|"Stable: no change in PSA kinetics Decrease: less than baseline Increase: greater than baseline~PSA data was gathered at baseline and off treatment."|Up to 14 months|Due to study closing early only 8 of planned 20 patients enrolled.|||Participants|||Count of Participants
2634171|NCT01816048|Secondary|Number of Subjects Who Experience Adverse Events While on Treatment With TAK 700|The number of subjects experiencing adverse events per CTCAE 4.0 while on treatment.|Up to 12 months||||participants|||Number
2634172|NCT01816048|Primary|Number of Participants With Change in Prostate Specific Antigen (PSA) Response Rate|Measure prostate specific antigen (PSA) response rate in patients treated with TAK700, as measured by a decline in the PSA level from baseline to the month 3 assessment according to the Prostate Cancer Clinical Trials Working Group (PCWG2), at least a 50% decrease from baseline. Percent increase or decrease from month three compared to baseline.|Baseline and 3 months|Study closed early and only 8 of planned 20 enrolled. Four subjects came off study prior to the three month time point.|||Participants|||Count of Participants
2634173|NCT01816048|Primary|Number of Participants With a Change in Maximum NaF PET/CT Standardized Uptake Values|To measure changes in NaF PET/CT standardized uptake values (SUVmax) from prior to dosing with Tak-700 to12 weeks after starting treatment with TAK-700. Value at three months minus value at baseline.|Baseline and 3 months|The study closed early so only 8 of 20 planned were enrolled and of the 8, only 4 completed the week 12 scan.|||Participants|||Count of Participants
2634174|NCT01815918|Secondary|Blinding Assessment|Throughout each patient's study participation, the patient and the data collector will be asked to guess their treatment status. This helps ascertain if there is an association between blinding status, treatment effect and the depression measure.|one month and up to 3 months following surgery|Outcome could not be analyzed because patients could not be reached to collect data at one month and up to 3 months following surgery.||||||
2634175|NCT01815918|Secondary|Pain Scores and Opioid Consumption|Pain scores (rated on a scale of 0-10) will be taken throughout study participation. We will also record analgesic use to see if patients who received hydrocortisone needed fewer pain killers to control their postoperative pain.|one month and up to 3 months following surgery|Outcome could not be analyzed because patients could not be reached to collect data at one month and up to 3 months following surgery.||||||
2634176|NCT01815918|Secondary|Hydrocortisone's Effect on Depression|Elevated IL-6 has been linked to post-operative depression following total knee replacement surgery. Patients will be administered the patient health questionnaire (PHQ-9) one month and 3 months following surgery to assess their well-being.|one month and up to 3 months following surgery|Outcome could not be analyzed because patients could not be reached to collect data at one month and up to 3 months following surgery.||||||
2634177|NCT01815918|Primary|Plasmin-alpha-2-antiplasmin Complex (PAP), a Marker of Fibrinolysis|Study patients received 100 mg of intravenous hydrocortisone 2 h prior to surgery, and controls received normal saline. Blood samples, drawn pre-incision and at 4 h post tourniquet release, were assayed for PF1.2 and PAP|Baseline and up to 4 hours following surgery||||ug/L||Standard Deviation|Mean
2634178|NCT01815918|Primary|Prothrombin Fragment (PF1.2), a Marker of Thrombin Generation|Study patients received 100 mg of intravenous hydrocortisone 2 h prior to surgery, and controls received normal saline. Blood samples, drawn pre-incision and at 4 h post tourniquet release, were assayed for PF1.2 and PAP|Baseline and up to 4 hours following surgery||||pMol/L||Standard Deviation|Mean
2634179|NCT01815840|Secondary|Percent Change From Baseline in the Skindex-16 Function Domain Score at Week 73|"The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their ability to function, and answers were combined into a composite Function Domain Score. Scores range from 0 (never bothered) to 100 (always bothered)."|Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.|||percent change||Standard Deviation|Mean
2634180|NCT01815840|Secondary|Percent Change From Baseline in the Skindex-16 Emotion Domain Score at Week 73|"The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their emotional state, and their answers were combined into a composite Emotion Domain Score. Scores range from 0 (never bothered) to 100 (always bothered)."|Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.|||percent change||Standard Deviation|Mean
2634198|NCT01815671|Primary|Number of Participants Who Experience Adverse Events Which Are Related or Possibly Related to the Colonoscopy Procedure|The number of participants who experience adverse events which are related or possibly related to the colonoscopy procedure will be tallied in each treatment arm.|24 hours||||participants|||Number
2634181|NCT01815840|Secondary|Percent Change From Baseline in the Skindex-16 Symptom Domain Score at Week 73|"The Skindex-16 is a patient-reported outcome health questionnaire. Participants were asked about their symptoms, and their answers were combined into a composite Symptom Domain Score. Scores range from 0 (never bothered) to 100 (always bothered)."|Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.|||percent change||Standard Deviation|Mean
2634182|NCT01815840|Secondary|Percentage of Participants Experiencing Any Adverse Event||Up to 125 weeks|Safety Analysis Population: participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) who received at least one dose of study treatment.|||percentage of participants|||Number
2634183|NCT01815840|Secondary|Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 125 (52 Weeks Following End of Treatment) (Recurrence Rate)||Baseline; Week 125|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.|||percent change||Standard Deviation|Mean
2634184|NCT01815840|Secondary|Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 97 (24 Weeks Following End of Treatment) (Recurrence Rate)||Baseline; Week 97|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.|||percent change||Standard Deviation|Mean
2634185|NCT01815840|Secondary|Percent Change in Total Number of Basal Cell Carcinomas Relative to Baseline at Week 85 (12 Weeks Following End of Treatment) (Recurrence Rate)||Baseline; Week 85|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.|||percent change||Standard Deviation|Mean
2634186|NCT01815840|Secondary|Percentage of Participants With New Basal Cell Carcinomas at Week 73||Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.|||percentage of participants|||Number
2634187|NCT01815840|Secondary|Percentage of Participants With at Least 50% Reduction in the Number of Basal Cell Carcinomas at Week 73||Baseline; Week 73|Intent-to-Treat Analysis Population, defined as all randomized participants.|||percentage of participants|||Number
2634188|NCT01815840|Secondary|Mean Percent Change From Baseline in Total Size of Three Target Basal Cell Carcinoma Lesions in Individual Participants at Week 73|The three target basal cell carcinoma lesions = the three largest visible lesions, at least 5 mm in the longest diameter, in individual participants.|Baseline; Week 73|Participants in the Intent-to-Treat Analysis Population (defined as all randomized participants) with available data were included in the analysis.|||percent change||Standard Deviation|Mean
2634189|NCT01815840|Secondary|Percentage of Participants Who Discontinued Study Treatment Due to Tolerability Issues|The percentage of participants who discontinued study treatment (due either to adverse event, refusal of treatment, or withdrawal of consent) was summarized by treatment group.|Baseline to Week 73|Intent-to-Treat Analysis Population, defined as all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2634190|NCT01815840|Primary|Mean Percent Change From Baseline in the Number of Clinically Evident Basal Cell Carcinomas at Week 73 (After 72 Weeks of Treatment)|The total number of clinically evident basal cell carcinomas = the total number of target and/or non-target lesions present in individual participants.|Baseline; Week 73|Participants in the Intent-to-Treat analysis population (defined as all randomized participants) with available data were included in the analysis. The last observation carried forward method was used.|||percent change||Standard Deviation|Mean
2634191|NCT01815736|Secondary|Change From Baseline in Overall EFV-related Symptom Assessment Score at Week 48|"The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream).~EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit."|Baseline; Week 48|"Participants in EFV-Related Symptom Analysis Set with available data were analyzed.~NDA Data Cut = participants through data cut for E/C/F/TAF NDA; All Participants = participants through Week 48 Data Cut"|||units on a scale||Standard Deviation|Mean
2634192|NCT01815736|Secondary|Change From Baseline in Serum Creatinine at Week 48||Baseline; Week 48|"Participants in the Safety Analysis Set (randomized participants who received ≥ 1 dose of study drug) excluding participants with prior treatment of EFV/FTC/TDF.~NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut"|||mg/dL||Standard Deviation|Mean
2634193|NCT01815736|Secondary|Percent Change From Baseline in Spine BMD at Week 48|Spine BMD was assessed by DXA scan. BMD is calculated as g/cm^2; the mean (SD) percentage change is presented.|Baseline; Week 48|"Participants in the Spine DXA Analysis Set (participants who received ≥ 1 dose of study drug and had nonmissing baseline spine BMD) with available data were analyzed.~NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut."|||percentage change||Standard Deviation|Mean
2634194|NCT01815736|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. BMD is calculated as grams per square centimeter (g/cm^2); the mean (SD) percentage change is presented.|Baseline; Week 48|"Participants in the Hip DXA Analysis Set (participants who received ≥ 1 dose of study drug and had nonmissing baseline hip BMD) with available data were analyzed.~NDA Data Cut = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut."|||percentage change||Standard Deviation|Mean
2634195|NCT01815736|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|"Full Analysis Set: participants who were randomized and received at least 1 dose of study drug.~New Drug Application (NDA Data Cut) = participants through the data cut for the E/C/F/TAF NDA; All Participants = participants through the Week 48 Data Cut."|||percentage of participants|||Number
2634199|NCT01815645|Secondary|Percentage Samples Submitted Negative for Marihuana Use|The proportion of samples testing negative for marijuana was determined by dividing the number of negative samples by the total number of expected samples (36 samples)|12 weeks||||percent of sample|percent of sample||Number
2634200|NCT01815645|Secondary|Percentage Samples Submitted Negative for Alcohol Use|Proportion of samples testing negative for alcohol use|12 weeks||||percent of sample|||Number
2634201|NCT01815645|Primary|Treatment Attendance|Treatment attendance was expressed as the total number of sessions attended during the 12 weeks of treatment.|12 weeks|we compared group means for the total number of attended sessions.|||attended treatment sessions||Standard Deviation|Mean
2634202|NCT01815645|Primary|Number of Participants Completing 4, 8 and 12 Weeks of Treatment|Retention in treatment was quantified as the period elapsed between treatment intake and dropout (last appearance at the treatment facility) or the end of treatment. We present data on the number of participants retained in treatment in weeks 4, 8 and 12.|Number of participant retained in treatment at weeks 4, 8 and 12.||||number of participants|||Number
2634203|NCT01815645|Primary|Percentage Samples Submitted Negative for Crack Cocaine Use|Proportion of samples testing negative for Crack Cocaine use|12 weeks||||percentage of submitted negative samples|urine samples||Number
2634204|NCT01815645|Primary|Longest Duaration of Achieved Abstinance|Number of Participants with 4, 8 and 12 Weeks Continued Abstinence|12 weeks of treatment|Longest duaration of abstinance was determined by the highest amount of consecutive negative crack/cocaine samples submitted.|||number of participants|||Number
2634205|NCT01815515|Secondary|Sensitivity of Detection of New or Progression of Metastasis|"Sensitivity of DCFBC-PET and conventional imaging modalities (CIM), which include bone scintigraphy (BS) and contrast-enhanced computed tomography (CECT) to detect new or progression of metastases at follow-up, where equivocal lesions are considered negative. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive, therefore, sensitivity is a proportion of responsive lesions to the total number of lesions analyzed."|up to 1 year|Follow-up CIM was only available for 12 of the 17 participants. 92% of the lesions detected via 18F-DCFBC PET were marked as true positive.|||proportion of responsive lesions||95% Confidence Interval|Number
2634206|NCT01815515|Primary|Measurement of Sensitivity of DCFBC-PET as Determined by Agreement of PET/CT Detection of Metastatic Prostate Cancer With Conventional Imaging Modality (CIM)|Measurement of sensitivity of DCFBC PET to CIM (contrast-enhanced CT and bone scintigraphy) for detection of metastatic prostate cancer based on number of lesions that are detected on PET/CT, in agreement with CT and CIM. Measurement of sensitivity were obtained on lesion by lesion analysis where lesions that responded on follow up were considered a true positive.|24 Months|Combined Imaging Modality (CIM) refers to both CT and BS imaging. The total number of lesions analyzed by both CT and BS (CIM) are 235 (as represented by PET-positive and PET-negative, equivocal CIM). There is overlap in the number of lesions detected by conventional imaging modalities (ie: bone scan and computed tomography)|||lesions detected|Lesions||Number
2634207|NCT01815502|Other Pre-specified|Preload Augmentation|Preload augmentation is a measure of how quickly the heart fills with blood during exercise|10 minutes after imitation of dobutamine||||ml/m^2||Inter-Quartile Range|Mean
2634208|NCT01815502|Other Pre-specified|Ventricular-arterial Coupling|Ventricular-arterial coupling is a measure of efficiency of ventricular work in response to the work created by the vascular tree|10 minutes after imitation of dobutamine||||ratio||Inter-Quartile Range|Mean
2634209|NCT01815502|Secondary|End-diastolic Pressure Volume Relationship|End-diastolic pressure volume relationship (EDPVR) is a measure of diastolic (relaxation) heart function|10 minutes after imitation of dobutamine||||mmHg/ms||Inter-Quartile Range|Mean
2634210|NCT01815502|Primary|End-systolic Elastance|end-systolic elastance (often abbreviated Ees or ESPVR) is a measure of contractility (systolic function)|10 minutes after imitation of dobutamine||||Ees in mmHg/ml/m2||Inter-Quartile Range|Mean
2634211|NCT01815424|Other Pre-specified|Number of Participants With Adjudicated Malignancy Events Reported During Week 0-52|As part of AE monitoring, potential malignancy events were adjudicated and centrally reviewed by a safety committee.|Baseline to Week 52|The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.|||participants|||Number
2634212|NCT01815424|Other Pre-specified|Number of Participants With Adjudicated Malignancy Events Reported During Week 0-16|As part of AE monitoring, potential malignancy events were adjudicated and centrally reviewed by a safety committee.|Baseline to Week 16|The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.|||participants|||Number
2634213|NCT01815424|Other Pre-specified|Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-52|CV event categories included: cerebrovascular accident (CVA), coronary revascularization procedure (percutaneous transluminal coronary angioplasty [PTCA], percutaneous coronary intervention [PCI], coronary bypass grafting [CABG], heart failure, major adverse cardiac events (MACE), myocardial infarction (MI), new ischemic heart disease, peripheral vascular disease (first diagnosis). MACE included any MI, CVA (stroke or transient ischemic attack), or CV death.|Baseline up to Week 52|The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.|||participants|||Number
2634214|NCT01815424|Other Pre-specified|Incidence of Participants With Adjudicated Cardiovascular (CV) Endpoints Reported During Week 0-16|CV event categories included: cerebrovascular accident (CVA), coronary revascularization procedure (percutaneous transluminal coronary angioplasty [PTCA], percutaneous coronary intervention [PCI], coronary bypass grafting [CABG], heart failure, major adverse cardiac events (MACE), myocardial infarction (MI), new ischemic heart disease, peripheral vascular disease (first diagnosis). MACE included any MI, CVA (stroke or transient ischemic attack), or CV death.|Baseline to Week 16|The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.|||participants|||Number
2634296|NCT01814826|Secondary|MTD Expansion Phase, Lambdaz: Terminal Disposition Phase Rate Constant for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||1/hr||Standard Deviation|Mean
2634215|NCT01815424|Other Pre-specified|Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-52|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: pulse rate less than (<)40 or greater than (>)120 beats per minute (bpm), heart rate less than (<)40 or greater than (>)120 bpm; sitting systolic blood pressure (SBP) of greater than or equal to (>=)30 millimeters of mercury (mmHg) change from baseline or sitting SBP <90 mmHg, sitting diastolic blood pressure (DBP) >=20 mmHg change from baseline or sitting DBP <50 mmHg.|Baseline to Week 52|The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo; n=number of evaluable participants at the specified time point.|||participants|||Number
2634216|NCT01815424|Other Pre-specified|Number of Participants With Vital Sign Values Meeting the Criteria for Potential Clinical Concern During Week 0-16|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: pulse rate less than (<)40 or greater than (>)120 beats per minute (bpm), heart rate less than (<)40 or greater than (>)120 bpm; sitting systolic blood pressure (SBP) of greater than or equal to (>=)30 millimeters of mercury (mmHg) change from baseline or sitting SBP <90 mmHg, sitting diastolic blood pressure (DBP) >=20 mmHg change from baseline or sitting DBP <50 mmHg.|Baseline to Week 16|The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo; n=number of participants evaluated against criteria.|||participants|||Number
2634217|NCT01815424|Other Pre-specified|Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-52|Study drugs were to be discontinued and the participant withdrawn for: 2 sequential absolute neutrophil counts (ANC) <1.0 X 10^9/L (1000/mm^3); 2 sequential absolute lymphocyte counts <0.5 X 10^9/L; 2 sequential hemoglobin values <9.0 g/dL and/or decreases of >30% from baseline value; 2 sequential platelet counts <75 X 10^9/L; 2 sequential AST or ALT elevations ≥3X ULN with at least 1 total bilirubin value ≥2X ULN (reason #1); 2 sequential AST or ALT elevations ≥5X ULN regardless of total bilirubin or accompanying signs or symptoms (reason #2); 2 sequential increases in serum creatinine >50% and an increase in serum creatinine >0.5 mg/dL over the average of screening and baseline values; 2 sequential CK elevations >10X ULN.|Baseline up to Week 52|The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.|||participants|||Number
2634218|NCT01815424|Other Pre-specified|Number of Participants With Laboratory Values Meeting Protocol Criteria for Discontinuation During Week 0-16|Study drugs were to be discontinued and the participant withdrawn for: 2 sequential absolute neutrophil counts (ANC) <1.0 X 10^9/L (1000/mm^3); 2 sequential absolute lymphocyte counts <0.5 X 10^9/L; 2 sequential hemoglobin values <9.0 g/dL and/or decreases of >30% from baseline value; 2 sequential platelet counts <75 X 10^9/L; 2 sequential AST or ALT elevations ≥3X ULN with at least 1 total bilirubin value ≥2X ULN (reason #1); 2 sequential AST or ALT elevations ≥5X ULN regardless of total bilirubin or accompanying signs or symptoms (reason #2); 2 sequential increases in serum creatinine >50% and an increase in serum creatinine >0.5 mg/dL over the average of screening and baseline values; 2 sequential CK elevations >10X ULN.|Baseline to Week 16|The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.|||participants|||Number
2634219|NCT01815424|Other Pre-specified|Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-52|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline to Week 52|The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.|||participants|||Number
2634220|NCT01815424|Other Pre-specified|Treatment-Emergent All Causalities Adverse Events (AEs) During Week 0-16|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline to Week 16|The safety analysis set included all participants who received at least 1 dose of tofacitinib or placebo.|||participants|||Number
2634221|NCT01815424|Secondary|Change From Baseline in EQ-5D - Visual Analog Scale (VAS) Over Time Through Week 52|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline and weeks 16, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
2634222|NCT01815424|Secondary|Euro Quality of Life 5 Dimensions (EQ-5D) - Visual Analog Scale (VAS) Over Time Through Week 52|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline and Weeks 16, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
2634297|NCT01814826|Secondary|Dose-escalation Phase, Lambdaz: Terminal Disposition Phase Rate Constant for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||1 per hour (1/hr)||Standard Deviation|Mean
2634223|NCT01815424|Secondary|Change From Baseline in EQ-5D - Utility Score Over Time Through Week 52|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a worse health state."|Baseline and weeks 16, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
2634224|NCT01815424|Secondary|Euro Quality of Life 5 Dimensions (EQ-5D) - Utility Score Over Time Through Week 52|"EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a worse health state."|Baseline, Weeks 16, 32, 40, 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
2634225|NCT01815424|Secondary|"Percentage of Participants With Patient Global Assessment (PtGA) Response of Clear or Almost Clear Over Time Through Week 52"|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe). the percentage of participants with scores of 0 (clear) and 1 (almost clear) are reported.|Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. NRI method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
2634226|NCT01815424|Secondary|Change From Baseline in DLQI Score Over Time Through Week 52|The DLQI is a 10 item general dermatology questionnaire that assesses health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Error|Least Squares Mean
2634227|NCT01815424|Secondary|Actual Dermatology Life Quality Index (DLQI) Score Over Time Through Week 52|The DLQI is a 10 item general dermatology questionnaire that assesses health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
2634228|NCT01815424|Secondary|Change From Baseline in ISI Score Over Time Through Week 52|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends."|Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Error|Least Squares Mean
2634229|NCT01815424|Secondary|Actual Itch Severity Item (ISI) Score Over Time Through Week 52|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
2634236|NCT01815424|Secondary|Percentage of Participants With PASI125 Over Time Through Week 52|"The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. Percentage of participants with PASI score of at least 125% of baseline PASI score are reported."|Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.|||percentage of participants||95% Confidence Interval|Number
2634230|NCT01815424|Secondary|Percentage of Participants With NAPSI100 Response Over Time Through Week 52|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores represents more severe psoriasis. NAPSI 100 response was defined as at least a 100% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 100 response is reported.|Weeks 8, 16, 20, 32, 40, and 52|Number of participants analyzed signifies the FAS participants (randomized and received at least 1 dose of investigational drug) who were evaluable (had nail psoriasis at Baseline and at least 1 measurement during follow up) for this measure. n=number of evaluable participants at the specified time point.|||percentage of participants||95% Confidence Interval|Number
2634231|NCT01815424|Secondary|Percentage of Participants With NAPSI75 Response Over Time Through Week 52|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores represents more severe psoriasis. NAPSI 75 response was defined as at least a 75% reduction in NAPSI relative to Baseline. Percentage of participants with NAPSI 75 response is reported.|Weeks 8, 16, 20, 32, 40, and 52|Number of participants analyzed signifies the FAS participants (randomized and received at least 1 dose of investigational drug) who were evaluable (had nail psoriasis at Baseline and at least 1 measurement during follow up) for this measure. n=number of evaluable participants at the specified time point.|||percentage of participants||95% Confidence Interval|Number
2634232|NCT01815424|Secondary|Percent Change From Baseline in NAPSI Over Time Through Week 52|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores represents more severe psoriasis.|Baseline and weeks 8, 16, 20, 32, 40, and 52|Number of participants analyzed signifies the FAS participants (randomized and received at least 1 dose of investigational drug) who were evaluable (had nail psoriasis at Baseline and at least 1 measurement during follow up) for this measure. n=number of evaluable participants at the specified time point.|||percent change||Standard Error|Least Squares Mean
2634233|NCT01815424|Secondary|Number of Affected Nails in Participants With Nail Psoriasis at Baseline Over Time Through Week 52|Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported. The total number of affected FINGER nails was reported.|Baseline and Weeks 8, 16, 20, 32, 40, and 52|Number of participants analyzed signifies the FAS participants (randomized and received at least 1 dose of investigational drug) who were evaluable (had nail psoriasis at Baseline and at least 1 measurement during follow up) for this measure. n=number of evaluable participants at the specified time point.|||nails||Standard Deviation|Mean
2634234|NCT01815424|Secondary|Change From Baseline in NAPSI Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail was divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores represents more severe psoriasis.|Baseline and weeks 8, 16, 20, 32, 40, and 52|Number of participants analyzed signifies the FAS participants (randomized and received at least 1 dose of investigational drug) who were evaluable (had nail psoriasis at Baseline and at least 1 measurement during follow up) for this measure. n=number of evaluable participants at the specified time point.|||units on a scale||Standard Error|Least Squares Mean
2634235|NCT01815424|Secondary|Actual Nail Psoriasis Severity Index (NAPSI) Score Over Time Through Week 52 in Participants With Nail Psoriasis at Baseline|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores represents more severe psoriasis.|Baseline and Weeks 8, 16, 20, 32, 40, and 52|Number of participants analyzed signifies the FAS participants (randomized and received at least 1 dose of investigational drug) who were evaluable (had nail psoriasis at Baseline and at least 1 measurement during follow up) for this measure. n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
2634298|NCT01814826|Secondary|MTD Expansion Phase, AUCinf: Area Under the Plasma Concentration-time Curve Extrapolated to Infinity for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||hr*ng/mL||Standard Deviation|Mean
2634237|NCT01815424|Secondary|Percentage of Participants With PASI90 Response Over Time Through Week 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least 90% reduction in PASI relative to Baseline. Percentage of participants with PASI90 response up to Week 52 is reported."|Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. NRI method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
2634238|NCT01815424|Secondary|Percentage of Participants With PASI50 Response Over Time Through Week 52|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. Percentage of participants with PASI50 response is reported."|Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. NRI method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
2634239|NCT01815424|Secondary|Percent Change From Baseline in BSA Over Time Through Week 52|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline and weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.|||percent change||Standard Error|Least Squares Mean
2634240|NCT01815424|Secondary|Actual BSA Over Time Through Week 52|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.|||percent BSA||Standard Deviation|Mean
2634241|NCT01815424|Secondary|Percent Change From Baseline in PASI Scores Over Time Through Week 52|"The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.|||percent change||Standard Error|Least Squares Mean
2634242|NCT01815424|Secondary|Change From Baseline in PASI Component Scores Over Time Through Week 52|"The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of body surface area (BSA) affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
2634299|NCT01814826|Secondary|Dose-escalation Phase, AUCinf: Area Under the Plasma Concentration-time Curve Extrapolated to Infinity for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||hr*ng/mL||Standard Deviation|Mean
2634243|NCT01815424|Secondary|PASI Component Scores Over Time Through Week 52|"The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
2634244|NCT01815424|Secondary|Change From Baseline in PASI Over Time Through Week 52|"The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
2634245|NCT01815424|Secondary|Actual PASI Scores Over Time Through Week 52|"The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; number of participants analyzed was the evaluable participants for the specific criteria; n=number of evaluable participants at the specified time point.|||percentage of participants||Standard Deviation|Mean
2634246|NCT01815424|Secondary|Percentage of Participants Achieving PASI75 Response Over Time Through Week 52|"The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least 75% reduction in PASI relative to Baseline. Percentage of participants with PASI 75 response is reported."|Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. NRI method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
2634247|NCT01815424|Secondary|Percentage of Participants in Each PGA Category Over Time Through Week 52|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). Percentage of participants with each PGA score is reported.|Baseline and Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo; n=number of evaluable participants at the specified time point.|||percentage of participants|||Number
2634248|NCT01815424|Secondary|Percentage of Participants With PGA Response of 'Clear' or 'Almost Clear' Over Time Through Week 52|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Weeks 2, 4, 8, 12, 16, 20, 32, 40, and 52|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. NRI method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants||95% Confidence Interval|Number
2634261|NCT01815424|Secondary|Percent Change From Baseline in Total Body Surface Area (BSA) With Psoriasis at Week 16|Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage [Head and neck = 10% (10 handprints), upper extremities = 20% (20 handprints), Trunk (including axillae and groin) = 30% (30 handprints), lower extremities (including buttocks) = 40% (40 handprints)]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.|Baseline to Week 16|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. Number of participants analyzed was the evaluable participants for the specific criteria.|||percent change||Standard Error|Least Squares Mean
2634249|NCT01815424|Secondary|Time to PASI50 Response up to Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 26). Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Baseline up to Week 16|Participants with non-missing post-baseline responses data in the full analysis population (all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo) were included.|||weeks||95% Confidence Interval|Median
2634250|NCT01815424|Secondary|Time to PASI75 Response up to Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 2). Median time to event is not estimable if less than 50% of participants had PASI50 response by Week 16."|Baseline up to Week 16|Participants with non-missing post-baseline responses data in the full analysis population (all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo) were included.|||weeks||95% Confidence Interval|Median
2634251|NCT01815424|Secondary|Time to PGA Response up to Week 16|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event was estimated based on the probability of event-rate based on life table estimates (not the observed rate as in outcome measure 1). Median time to event is not estimable if less than 50% of participants had PGA response by Week 16.|Baseline to Week 16|Participants with non-missing post-baseline response data in the full analysis population (all participants who were randomized to the study and received at least 1 dose of study drug) were included.|||weeks||95% Confidence Interval|Median
2634252|NCT01815424|Secondary|Percentage of Participants Maintaining PASI90 Response at Week 52 Among Participants Achieving PASI90 at Week 16|The PASI quantifies severity of a participant's psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response=at least 90% reduction in PASI relative to Baseline. Maintenance of PASI90 response at Week 52 among patients achieving PASI90 response at Week 16 is reported. This is a key secondary endpoint. Probability and the 95% CI were estimated based on the Kaplan-Meier method. Event is loss of response. Percentage of maintaining response is (1-probability of loss of response).|Week 16 to Week 52|Patients in the full analysis population and those who had PASI90 response at Week 16 and non-missing post Week 16 data were included. Patients initially treated with placebo were not included as they were advanced to tofacitinib and this maintaining response at Week 52 was not relevant.|||percentage of participants||95% Confidence Interval|Number
2634253|NCT01815424|Secondary|Percentage of Participants Maintaining PASI75 Response at Week 52 Among Participants Achieving PASI75 Response at Week 16|The PASI quantifies severity of a participant's psoriasis based on both lesion severity and percent of BSA affected. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks), with adjustment for percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response=at least 75% reduction in PASI relative to Baseline. Maintenance of PASI75 response at Week 52 among patients achieving PASI75 response at Week 16 is reported. This is a key secondary endpoint. Probability and the 95% CI were estimated based on the Kaplan-Meier method. Event is loss of response. Percentage of maintaining response is (1-probability of loss of response).|Week 16 to Week 52|Patients in the full analysis population and those who had PASI75 response at Week 16 and non-missing post Week 16 data were included. Patients initially treated with placebo were not included as they were advanced to tofacitinib and this maintaining response at Week 52 was not relevant.|||percentage of participants||95% Confidence Interval|Number
2634275|NCT01814878|Secondary|Patient Global Impression of Change (PGIC) Score|The PGIC was used to assess the degree of participant's overall improvement with treatment, and participants were instructed to assess how much the overall status had been improved after investigational product administration compared to baseline in 7 grades (1=Very much improved and B=Very much worsened).|Day 3|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.|||Units on scale||Standard Deviation|Mean
2634331|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Tetanus|Summary of trough antibody concentrations prior to specified infusion for Tetanus|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||IU/mL||Standard Error|Mean
2634254|NCT01815424|Secondary|"Percentage of Participants Maintaining PGA Score of Clear or Almost Clear at Week 52 Among Participants Achieving PGA Response at Week 16"|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among patients achieving PGA response at Week 16 is reported. This is a key secondary endpoint. Percentage of participants maintaining the response and the 95% confidence interval (CI) were estimated based on the Kaplan-Meier method. Event is loss of response. Percentage of maintaining response is (1-probability of loss of response).|Week 16 to Week 52|Patients in the full analysis population and those who had PGA response at Week 16 and non-missing post Week 16 data were included. Patients initially treated with placebo were not included as they were advanced to tofacitinib and this maintaining response at Week 52 was not relevant.|||percentage of participants||95% Confidence Interval|Number
2634255|NCT01815424|Secondary|Percent Change From Baseline in Nail Psorasis Severity Index (NAPSI) at Week 16 in Participants With Nail Psoriasis at Baseline|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores represent more severe psoriasis.|Baseline to Week 16|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. Number of participants analyzed signifies those participants who were evaluable (had nail psoriasis at Baseline and had at least one measurement during follow up) for this measure..|||percent change||Standard Error|Least Squares Mean
2634256|NCT01815424|Secondary|Change From Baseline in DLQI Total Score at Week 4|The DLQI is a 10 item general dermatology questionnaire that assesses health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline to Week 4|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. Number of participants analyzed was the evaluable participants for the specific criteria.|||scores on a scale||Standard Error|Least Squares Mean
2634257|NCT01815424|Secondary|Percentage of Participants Achieving PASI75 Response at Week 4|"The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline."|Week 4|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. NRI method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants|||Number
2634258|NCT01815424|Secondary|"Percentage of Participants With PGA Score of Clear or Almost Clear at Week 4"|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 4|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. NRI method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants|||Number
2634259|NCT01815424|Secondary|Change From Baseline in DLQI Total Score at Week 16|The DLQI is a 10 item general dermatology questionnaire that assesses health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline to Week 16|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. Number of participants analyzed was the evaluable participants for the specific criteria.|||scores on a scale||Standard Error|Least Squares Mean
2634260|NCT01815424|Secondary|Percentage of Participants Achieving at Least a 90% Reduction in PASI (PASI90) at Week 16|The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least a 90% reduction in PASI relative to Baseline.|Week 16|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. NRI method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants|||Number
2665177|NCT01536093|Secondary|Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines||1 week of age|||||||
2634262|NCT01815424|Primary|Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75% reduction in PASI relative to Baseline."|Week 16|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. NRI method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants|||Number
2634263|NCT01815424|Primary|"Percentage of Participants With Physician's Global Assessment (PGA) Score of Clear or Almost Clear at Week 16"|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 16|The full analysis population included all participants who were randomized to the study and received at least 1 dose of tofacitinib or placebo. Non-Responder Imputation (NRI) method (participants with missing values considered as non-responders) was used to impute missing values.|||percentage of participants|||Number
2634264|NCT01815229|Secondary|Intubation Time in Minutes|Average amount of time that participants were intubated|Up to 363 minutes for intubation time|Healthy control were not intubated.|||minutes||Full Range|Mean
2634265|NCT01815229|Primary|Neutrophil Cell Counts in Tracheal Lavages|Neutrophil cell count were collected after an average of 3.2 hours of exposure to an ETT. Cell counts were performed using 10x6 per ml|average of 3.2 hours of exposure to an ETT|Blood samples were collected form healthy controls for in vitro analysis. Neutrophil data was not collected for healthy controls.|||neutrophil/high powered field||Standard Deviation|Mean
2634266|NCT01815138|Other Pre-specified|Proportion of Patients With Abdominal Distension|Patients will complete a questionnaire to determine if there is a difference in the effect of the intervention on the quality of life (abdominal distension) of the patients from the day of trigger of oocyte maturation until menses or positive pregnancy test.|Within 2 weeks after trigger of oocyte maturation|Some patients did not complete the questionnaire. Abdominal distension analyzed|||Participants|||Count of Participants
2634267|NCT01815138|Other Pre-specified|Markers of Corpus Luteum Function|A subset of patients (20 patients in each group) will have serum frozen for subsequent analysis of 17 hydroxy progesterone and prorenin.|Within 60 days after trigger of oocyte maturation|Subset of women included in larger study, normal or high responders, peak estradiol level less than 4000 pg/mL on day of trigger.|||ng/mL||Standard Deviation|Mean
2634268|NCT01815138|Secondary|Ovarian Hyperstimulation Syndrome|Evaluation of symptoms and signs of OHSS at 9 days after trigger of oocyte maturation. Patients who also present with symptoms of OHSS wil also be evaluated for OHSS within 4 weeks after oocyte maturation.|Within 4 weeks of oocyte retrieval|Women with normal or high response to IVF, peak estradiol on day of trigger less than 4000 pg/mL.|||Participants|||Count of Participants
2634269|NCT01815138|Primary|Ongoing Pregnancy|Positive serum pregnancy test and ultrasound evidence of fetal pole and fetal heart rate .|Through time of study completion, on average 1-2years|per protocol analysis|||participants|||Number
2634270|NCT01815099|Primary|Change in The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Before and After TMS Treatment.|The Hamilton Anxiety Rating Scale (HARS) is one of the most commonly used and extensively validated outcome measures for anxiety symptoms. The SIGH-A allows for a standardized administration of the HARS. The total score was used in this study. The total score ranges from 0 to 56 with higher scores indicative of more severe anxiety symptoms.|Approximately 1 week prior to initial TMS treatment session, 1 week after final TMS treatment session|rTMS treatment completers|||units on a scale||Standard Deviation|Mean
2634271|NCT01815008|Secondary|Changes in Platelet Transcriptome With Clopidogrel|Platelet transcriptome will be examined before and after 1 week of therapy with clopidogrel and differences will be determined|At baseline and at 1 week|Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding. Note that the top most gene (CNOT2) with the lowest p-value is being reported.|||FPKM||Standard Error|Mean
2634272|NCT01815008|Secondary|Difference in Collagen-induced Platelet Aggregation|Collagen-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined|At Baseline and at 1 week|Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding.|||Difference in ohms (Post-Pre)||Standard Deviation|Mean
2634273|NCT01815008|Secondary|Difference in Arachidonic Acid-induced Platelet Aggregation|Arachidonic Acid-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined|At baseline and after 1-week|Data was collected before and after one week of clopidogrel. We found it difficult to enroll patients with low risk to the combined aspirin and clopidogrel and hence study was continued for the first week only.|||Difference in ohms (Post-Pre)||Standard Deviation|Mean
2634274|NCT01815008|Primary|Difference in ADP-induced Platelet Aggregation|ADP-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined. Higher impedance represent higher platelet aggregation.|at baseline and at 1 week|Data was collected before and after one week of clopidogrel. We found it difficult to enroll patients with low risk to the combined aspirin and clopidogrel and hence study was continued for the first week only.|||Difference in ohms (Post-Pre)||Standard Deviation|Mean
2634276|NCT01814878|Secondary|Dosage of Rescue Medication Administered Because of Insufficient Pain Relief|The dosage of the rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief was measured after administration of the study drug. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular or intravenous injection).|Baseline up to Day 3|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.|||Milligram||Standard Deviation|Mean
2634277|NCT01814878|Secondary|Number of Doses of Rescue Medication Administered Because of Insufficient Pain Relief|The frequency of the rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief was measured after administration of the study drug. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular or intravenous injection).|Baseline up to Day 3|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.|||Doses||Standard Deviation|Mean
2634278|NCT01814878|Secondary|Time to the First Rescue Medication Administered Because of Insufficient Pain Relief|The time until administration of the first rescue medication (rescue medications are medicines that are administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation) because of insufficient pain relief after administration of the study drug was recorded. Rescue medications allowed were oral or injection of tramadol HCl (intramuscular [directly into muscle] or intravenous injection [directly into vein]).|Baseline up to Day 3|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.|||Minutes||Standard Deviation|Mean
2634279|NCT01814878|Secondary|Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID)|The SPRID is sum of SPID and TOTPAR. In SPID, PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <= 3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. In TOTPAR, pain relief score ranges from 0-4 (0=no change, 1=slight relief, 2=moderate relief, 3=fair relief, 4=pain resolved completely). Total score ranges from -18 (worst) to 42 (best) for SPRID6, -36 (worst) to 84 (best) for SPRID12, -72 (worst) to 168 (best) for SPRID24 and -144 (worst) to 336 (best) for SPRID48.|Hour 6, 12, 24, 48|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.|||Units on scale||Standard Deviation|Mean
2634280|NCT01814878|Secondary|Total Pain Relief (TOTPAR) Score|Pain relief was measured on a 5-point categorical scale of 0-4 (0=no change, 1=slight relief, 2=moderate relief, 3=fair relief, 4=pain resolved completely). TOTPAR was calculated as the time-weighted sum over all pain relief up to 48 hours. Total score ranges from 0 (worst) to 24 (best) for TOTPAR6, 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24 and 0 (worst) to 192 (best) for TOTPAR48.|Hour 6, 12, 24, 48|The intent-to-treat population included all randomly assigned participants. Here, 'N' specifies those participants who were evaluable for this outcome measure.|||Units on scale||Standard Deviation|Mean
2634281|NCT01814878|Secondary|Sum of Pain Intensity Difference (SPID) at Hour 6, 12 and 24|The SPID is time-weighted sum of all observations of PID collected at each measurement time point from Baseline to 24 hours. PID: Baseline PI minus current PI; PI was assessed using 11-point NRS, 0=no pain to 10=worst pain imaginable. PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <=3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. Total score ranges from -18 (worst) to 18 (best) for SPID6, -36 (worst) to 36 (best) for SPID12 and -72 (worst) to 72 (best) for SPID24.|Hour 6, 12, 24|The intent-to-treat population included all randomly assigned participants. Here, 'N' (number of participants analyzed) specifies those participants who were evaluable for this outcome measure.|||Units on scale||Standard Deviation|Mean
2634282|NCT01814878|Primary|Sum of Pain Intensity Difference (SPID) at Hour 48|The SPID is time-weighted sum of all observations of pain intensity difference (PID) collected at each measurement time point from Baseline to 48 hours. PID: Baseline pain intensity (PI) minus current PI; PI was assessed using 11-point numeric rating scale (NRS, 0=no pain to 10=worst pain imaginable). PI score ranges from 0-3 where 0=no pain and 3=severe pain. PI score of 0=NRS score of 0, PI score of 1=NRS score >=1 and <=3, PI score of 2=NRS score of >=4 and <=6 and PI score of 3=NRS score of >=7 and <=10. Total score for SPID at 48 hours (SPID48) ranges from -144 (worst) to 144 (best).|Hour 48|The per-protocol (PP) population included all randomly assigned participants who did not violate major eligibility criteria and whose SPID was calculated with actual measurements or adjusted values at all assessment time points.|||Units on scale||Standard Deviation|Mean
2634283|NCT01814826|Secondary|Sixty-day Mortality Rate||60 days after the first dose of study drug on Cycle 1 (Cycle Length=28 days)|No participant was analyzed since this outcome measure was not planned to be assessed but added in the protocol summary by error.||||||
2634284|NCT01814826|Secondary|Thirty-day Mortality Rate||30 days after the first dose of study drug in Cycle 1 (Cycle Length=28 days)|The safety population was defined as all enrolled participants who receive at least 1 dose of any study drug, MLN4924 or azacitidine.|||percentage of participants|||Number
2634285|NCT01814826|Secondary|Overall Survival|Overall survival was defined as the time from the first dose of study drug to the date of death. The Kaplan-Meier method was used to estimate overall survival, along with the corresponding 95% confidence interval.|From the first dose of study drug up to date of death (up to 5 years)|The safety population was defined as all enrolled participants who receive at least 1 dose of any study drug, MLN4924 or azacitidine.|||months||95% Confidence Interval|Median
2634332|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Respiratory Syncytial Virus (RSV)|Summary of trough antibody concentrations prior to specified infusion for Respiratory Syncytial Virus (RSV)|Up to 1 year|Number available for analysis varied by infusion; 51-56 subjects|||titer||Standard Error|Mean
2639591|NCT01763905|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2634286|NCT01814826|Secondary|Duration of Response|The duration of response was defined in participants with disease response (CR, CRi, or PR) as the time between the first documentation of response and disease progression. Duration of response was determined by an investigator based on revised recommendations of the IWG Response Criteria for AML. CR: free of leukemia-related symptoms, absolute neutrophil count (ANC) greater than (>)1.0*10^9 per liter (/L), platelet count greater than or equal to (>=) 100*10^9/L, normal bone marrow with <5 percent (%) blasts and no Auer rods. CRi: As per CR but with residual thrombocytopenia (platelet count <100*10^9/L) or residual neutropenia (ANC <1.0*10^9/L). PR: >=50% decrease bone marrow blasts to 5 to 25% abnormal cells, or CR with less than or equal to (<=) 5% blasts if Auer rods present.|From the date of first documented CR, PR or CRi up to the date of first disease progression (Up to 5 years)|The response-evaluable population was defined as all participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post baseline disease assessment. Participants who were evaluable at a particular time point for this outcome measure were included in the assessment.|||months||95% Confidence Interval|Median
2634287|NCT01814826|Secondary|Best Overall Response Rate|Disease response was based on best overall response as determined by an investigator based on revised recommendations of the International Working Group (IWG) Response Criteria for AML. Best overall response rate was defined as percentage of participants who had complete response (CR), partial response (PR), or CR/remission with incomplete blood count recovery (Cri). CR: free of leukemia-related symptoms, absolute neutrophil count (ANC) greater than (>)1.0*10^9 per liter (/L), platelet count greater than or equal to (>=) 100*10^9/L, normal bone marrow with <5 percent (%) blasts and no Auer rods. CRi: As per CR but with residual thrombocytopenia (platelet count <100*10^9/L) or residual neutropenia (ANC <1.0*10^9/L). PR: >=50% decrease bone marrow blasts to 5 to 25% abnormal cells, or CR with less than or equal to (<=) 5% blasts if Auer rods present.|Cycle(C)1Day(D)22 and at C2 between D20 and 28 and at C4 and beyond C4 after completion of every 3rd C between D15 and 28 up to 30 days after last dose of study drug/before start of subsequent antineoplastic therapy, if that occurred sooner(up to 5 years)|The response-evaluable population was defined as all participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post baseline disease assessment. Participants who were evaluable at a particular time point for this outcome measure were included in the assessment.|||percentage of participants|||Number
2634288|NCT01814826|Secondary|MTD Expansion Phase, Vss: Volume of Distribution at Steady-state for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||liter||Standard Deviation|Mean
2634289|NCT01814826|Secondary|Dose-escalation Phase, Vss: Volume of Distribution at Steady-state for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||liter (L)||Standard Deviation|Mean
2634290|NCT01814826|Secondary|MTD Expansion Phase, CLp: Systemic Clearance for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||L/hr||Standard Deviation|Mean
2634291|NCT01814826|Secondary|Dose-escalation Phase, CLp: Systemic Clearance for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||liter per hour (L/hr)||Standard Deviation|Mean
2634292|NCT01814826|Secondary|MTD Expansion Phase, Rac: Observed Accumulation Ratio for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||ratio||Standard Deviation|Mean
2634293|NCT01814826|Secondary|Dose-escalation Phase, Rac: Observed Accumulation Ratio for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||ratio||Standard Deviation|Mean
2634294|NCT01814826|Secondary|MTD Expansion Phase, t1/2: Terminal Disposition Phase Half-life for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||hour||Standard Deviation|Mean
2634295|NCT01814826|Secondary|Dose-escalation Phase, t1/2: Terminal Disposition Phase Half-life for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||hour||Standard Deviation|Mean
2634333|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Haemophilus Influenzae Type B|Summary of trough antibody concentrations prior to specified infusion for Haemophilus influenzae type B|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||ug/mL||Standard Error|Mean
2634300|NCT01814826|Secondary|MTD Expansion Phase, AUC24hours: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Post-Dose for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||hr*ng/mL||Standard Deviation|Mean
2634301|NCT01814826|Secondary|Dose-escalation Phase, AUC24hours: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours Post-Dose for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||hr*ng/mL||Standard Deviation|Mean
2634302|NCT01814826|Secondary|MTD Expansion Phase, AUC0-tau: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (Tau) for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||hr*ng/mL||Standard Deviation|Mean
2634303|NCT01814826|Secondary|Dose-escalation Phase, AUC0-tau: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (Tau) for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
2634304|NCT01814826|Secondary|MTD Expansion Phase, Ctrough: Observed Plasma Concentration at the End of the Dosing Interval for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||ng/mL||Standard Deviation|Mean
2634305|NCT01814826|Secondary|Dose-escalation Phase, Ctrough: Observed Plasma Concentration at the End of the Dosing Interval for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||ng/mL||Standard Deviation|Mean
2634306|NCT01814826|Secondary|MTD Expansion Phase, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||hour||Full Range|Median
2634307|NCT01814826|Secondary|Dose-escalation Phase, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||hour||Full Range|Median
2634308|NCT01814826|Secondary|Maximum Tolerated Dose (MTD) Expansion Phase, Cmax: Maximum Observed Plasma Concentration for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length = 28 days)|The PK-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||ng/mL||Standard Deviation|Mean
2634309|NCT01814826|Secondary|Dose-escalation Phase, Cmax: Maximum Observed Plasma Concentration for MLN4924||Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose; Cycle 1 Day 5 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length is equal to [=] 28 days)|The pharmacokinetic (PK)-evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and MLN4924 concentration-time data to reliably estimate PK parameters. The PK population where data at specified time points was available.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2634310|NCT01814826|Primary|Number of Participants With TEAEs Related to Clinically Significant Vital Sign Findings||Baseline up to 30 days after the last dose of study drug (up to 5 years)|The safety population was defined as all enrolled participants who receive at least 1 dose of any study drug, MLN4924 or azacitidine.|||Participants|||Count of Participants
2634311|NCT01814826|Primary|Number of Participants With TEAEs Related to Clinically Significant Laboratory Evaluation Findings||Baseline up to 30 days after the last dose of study drug (up to 5 years)|The safety population was defined as all enrolled participants who receive at least 1 dose of any study drug, MLN4924 or azacitidine.|||Participants|||Count of Participants
2634312|NCT01814826|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||Baseline up to 30 days after the last dose of study drug (up to 5 years)|The safety population was defined as all enrolled participants who receive at least 1 dose of any study drug, MLN4924 or azacitidine.|||Participants|||Count of Participants
2634334|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - IgG|Summary of trough total IgG concentration prior to specified infusion|Up to 1 year||||mg/dL||Standard Error|Mean
2634313|NCT01814813|Secondary|Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5)|"The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below."|Up to 3 years|Patients who started at least one cycle of treatment and were assessed for adverse events were included in this analysis.|||Participants|||Count of Participants
2634314|NCT01814813|Secondary|Progression Free Survival (PFS)|Time to progression free survival: which is defined as the date from study registration to the date of first observation of disease progression or death due to any cause (whichever comes first). Progressive disease is defined as one or more of the following:New contrast-enhancing lesion outside of radiation field on decreasing, stable, or increasing doses of corticosteroids, increase by > 50% enhancement from the first post-surgical scan, or a subsequent scan with smaller tumor size, and the scan 8 weeks or later on stable or increasing doses of corticosteroids, clinical deterioration not attributable to concurrent medication or comorbid conditions is sufficient to declare progression on current treatment, for patients receiving bevacizumab therapy, significant increase in T2/FLAIR non-enhancing lesion.|Up to 5 years post-surgery||||months||95% Confidence Interval|Median
2634315|NCT01814813|Primary|Overall Survival (OS)|The primary endpoint is overall survival (OS), which is defined as the date from study > registration to the date of death, due to any cause.|Up to 5 years post-surgery||||months||95% Confidence Interval|Median
2634316|NCT01814800|Post-Hoc|Number of Participants With No Days Lost From Work/School/Daycare Due to Infections and Their Treatment|Additional analysis performed to separate the number of days lost from work, school and/or daycare from the days missed from normal activities, due to infection. Presenting the number of subjects with no (0) days lost from work/school/daycare due to infection|Up to 1 year|Analysis includes 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||participants|||Number
2634317|NCT01814800|Post-Hoc|Number of Days Lost From Work/School/Daycare Due to Infections and Their Treatment - Per Subject-Year|Additional analysis performed to separate the number of days lost from work, school and/or daycare from the days missed from normal activities, due to infection|Up to 1 year|Analysis includes 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days per subject-year|||Number
2634318|NCT01814800|Post-Hoc|Number of Days Lost From Work/School/Daycare Due to Infections and Their Treatment|Additional analysis performed to separate the number of days lost from work, school and/or daycare from the days missed from normal activities, due to infection|Up to 1 year|Analysis includes 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days|||Number
2634319|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 23F|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 23F|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||ug/mL||Standard Error|Mean
2634320|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19F|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 19F|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||ug/mL||Standard Error|Mean
2634321|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 19A|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 19A|Up to 1 year|Number available for analysis varied by infusion; 51-54 subjects|||ug/mL||Standard Error|Mean
2634322|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 18C|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 18C|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||ug/mL||Standard Error|Mean
2634323|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 14|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 14|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||ug/mL||Standard Error|Mean
2634324|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 9V|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 9V|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||ug/mL||Standard Error|Mean
2634325|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 7F|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 7F|Up to 1 year|Number available for analysis varied by infusion; 53-57 subjects|||ug/mL||Standard Error|Mean
2634326|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 6B|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 6B|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||ug/mL||Standard Error|Mean
2634327|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 5|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 5|Up to 1 year|Number available for analysis varied by infusion; 52-58 subjects|||ug/mL||Standard Error|Mean
2634328|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 4|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 4|Up to 1 year|Number available for analysis varied by infusion; 53-58 subjects|||ug/mL||Standard Error|Mean
2634329|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 3|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 3|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||ug/mL||Standard Error|Mean
2634330|NCT01814800|Secondary|Trough Total IgG and Specific Antibody Levels - Streptococcus Pneumoniae, Serotype 1|Summary of trough antibody concentrations prior to specified infusion for Streptococcus Pneumoniae, Serotype 1|Up to 1 year|Number available for analysis varied by infusion; 53-59 subjects|||ug/mL||Standard Error|Mean
2634335|NCT01814800|Secondary|Correlation Between Trough Level of RI-002 and Serious and Non-serious Infections|The relationship between trough IgG concentrations and the number of infections of any kind/seriousness was evaluated using Pearson linear correlation coefficients using forward analysis (outcomes after infusion) and backward analysis (outcomes prior to infusion; outcomes post last infusion were excluded)|Up to 1 year||||Linear Correlation Coefficients|||Number
2634336|NCT01814800|Secondary|Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection) - Per Subject-Year|Summary of the days of antibiotic therapy in the study for prophylaxis, as treatment for infections, and combined, per subject-year of treatment with RI-002|Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days per subject-year|||Number
2634337|NCT01814800|Secondary|Number of Days of Antibiotic Therapy (Prophylaxis and Treatment of Infection)|Summary of the days of antibiotic therapy in the study for prophylaxis, as treatment for infections, and combined|Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days|||Number
2634338|NCT01814800|Secondary|Days of Hospitalization Due to Infections - Per Subject-Year||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days per subject-year|||Number
2634339|NCT01814800|Secondary|Days of Hospitalization Due to Infections||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days|||Number
2634340|NCT01814800|Secondary|Number of Hospitalizations Due to Infections - Per Subject-Year||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Hospitalizations per subject-year|||Number
2634341|NCT01814800|Secondary|Number of Hospitalizations Due to Infections||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Number of hospitalizations|||Number
2634342|NCT01814800|Secondary|Time to Resolution of Infections - Infection Days Per Subject||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days per subject||Standard Deviation|Mean
2634343|NCT01814800|Secondary|Time to Resolution of Infections - Duration Per Infection||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days||Standard Deviation|Mean
2634344|NCT01814800|Secondary|Number of Unscheduled Visits to Physician/ER Due to Infections - Per Subject-Year||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Number of Visits per subject-year|||Number
2634345|NCT01814800|Secondary|Number of Unscheduled Visits to Physician/ER Due to Infections - Total Number of Visits||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Number of Visits|||Number
2634346|NCT01814800|Secondary|Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Per Subject-Year||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days per subject-year|||Number
2634347|NCT01814800|Secondary|Number of Days Lost From Work/School/Daycare and Usual Activities Due to Infections and Their Treatment - Combined Days Lost||Up to 1 year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||Days|||Number
2634348|NCT01814800|Secondary|Incidence of All Infections (Serious and Non-serious)||Up to 1 Year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||events per subject-year|||Number
2634349|NCT01814800|Primary|Number of Serious Bacterial Infections (SBIs) Per Subject Per Year (FDA Guidance for Industry (2008))|The primary objective of this study was to demonstrate that RI-002 (IGIV) reduces the frequency of serious bacterial infections (SBIs), as defined by the Diagnostic Criteria for Serious Infection Types guideline, in subjects with primary humoral immunodeficiency.|One year|Analysis included 59 treated subjects, with a total of 55.88 subject-years of treatment with RI-002|||SBIs/subject/year|||Number
2634350|NCT01814787|Primary|Number of Children With Documented Risk Factors for Type 2 Diabetes|Number of children (ages 10 and older) with documented risk factors for type 2 diabetes (>85%BMI and 2 of 4 Risk Factors)|12 months||||Participants|||Count of Participants
2634351|NCT01814774|Secondary|Botulinum Toxin Inter-injection Interval|Injection-interval was the time in weeks between injections of botulinum toxin.|2 Years|All participants who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.|||weeks||Standard Deviation|Mean
2634352|NCT01814774|Secondary|Number of Participants With Adverse Events|An Adverse Event was any unfavorable and unintended sign, symptom, or disease documented in the medical chart that occurred after treatment with botulinum toxin, or pre-existing conditions that worsened during the retrospective period.|2 Years|Safety population included all participants who received at least one dose of botulinum toxin.|||participants|||Number
2634353|NCT01814774|Primary|Dose of Botulinum Toxin Used to Treat Blepharospasm|The average dose of botulinum toxin received per patient per year was calculated.|2 Years|Participants diagnosed with Blepharospasm who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.|||units per patient per year||95% Confidence Interval|Mean
2634354|NCT01814774|Primary|Dose of Botulinum Toxin Used to Treat Cervical Dystonia|The average dose of botulinum toxin received per patient per year was calculated.|2 Years|Participants diagnosed with Cervical Dystonia who received onabotulinumtoxinA for 2 years and incobotulinumtoxinA for 2 years.|||units per patient per year||95% Confidence Interval|Mean
2634355|NCT01814761|Secondary|Overall Percent Change From Baseline in IOP|IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement) and a positive number change response indicates an increase in IOP (worsening).|Baseline, Week 12|Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment|||Percentage Change||95% Confidence Interval|Mean
2634379|NCT01814670|Secondary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest|The Investigator assessed the severity of the subject's glabellar rhytides at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 14, Day 30, Day 90, Day 120|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1|||Percentage of Subjects|||Number
2634356|NCT01814761|Primary|Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale|Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5-point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of patients in each severity grade are presented.|12 Weeks|Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment|||Patients|||Number
2634357|NCT01814761|Secondary|Percentage of Patients Who Discontinue Due to an Adverse Event|An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related.|12 Weeks|Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment|||Percentage of Patients|||Number
2634358|NCT01814761|Secondary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).|Baseline, Week 12|Intent-to-Treat: Enrolled patients who received at least one dose of study medication and who were not currently treated with Bimatoprost 0.01% at the time of enrollment|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2634359|NCT01814748|Secondary|Percentage of Participants Who Required Glycemic Rescue by Week 24|"Participants exceeding pre-specified glycemic thresholds after starting the double-blind treatment period may have received rescue therapy (per protocol) with open-label metformin initiated by the investigator.~This analysis may have been confounded by the use of metformin prohibited by the protocol (see efficacy results description above)."|Up to Week 24|All randomized participants.|||Percentage of participants|||Number
2634360|NCT01814748|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <6.5% (48 mmol/Mol) at Week 24|"Percentage of participants was estimated using standard multiple imputation techniques (cLDA). Within-group CIs were calculated via the Wilson score method.~The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Week 24|FAS population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.|||Percentage of participants||95% Confidence Interval|Number
2634361|NCT01814748|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7.0% at Week 24|"Percentage of participants was estimated using standard multiple imputation techniques (constrained longitudinal data analysis [cLDA] model). Within-group confidence intervals (CIs) were calculated via the Wilson score method.~The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Week 24|FAS population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.|||Percentage of participants||95% Confidence Interval|Number
2634362|NCT01814748|Secondary|Change in Baseline in FPG at Week 24|"Blood glucose was measured on a fasting basis.~The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Baseline and Week 24|FAS population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
2634363|NCT01814748|Secondary|Change From Baseline in 2-hr PMG at Week 24|"Blood glucose was measured 120 minutes from start of meal.~The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Baseline and Week 24|FAS population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
2634364|NCT01814748|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|"An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Data presented exclude data following the initiation of glycemic rescue.~The safety database was analyzed in a standard fashion in the APaT population for all participants who took at least one dose of study medication. This analysis may have been confounded by the use of metformin prohibited by the protocol (see efficacy results description above)."|Up to Week 24|APaT population included all randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
2665178|NCT01536093|Secondary|Concentration of Urinary IL-1 Beta||2 weeks of age||||ug per g creatinine||Standard Deviation|Mean
2634365|NCT01814748|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|"An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Data presented exclude data following the initiation of glycemic rescue.~The safety database was analyzed in a standard fashion in the all participants as treated (APaT) population for all participants who took at least one dose of study medication. This analysis may have been confounded by the use of metformin prohibited by the protocol (see efficacy results description above)."|Up to Week 27|APaT population included all randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
2634366|NCT01814748|Primary|Change From Baseline in A1C at Week 24|"A1C (%) is used to report average blood glucose levels over prolonged periods of time.~The unexpected absence of a treatment effect in this study led to investigations that included measurement of metformin levels in available samples collected for future research during the study. Of the 92 participants with samples who had not been rescued with metformin, 57% (25/44) in the placebo group and 29% (14/48) in the omarigliptin group had detectable metformin, indicating the use of metformin that was prohibited by the protocol. The use of metformin prohibited by the protocol was without investigator knowledge and is a confounding factor impacting the ability to draw any conclusions regarding the efficacy results from this study."|Baseline and Week 24|Full analysis set (FAS) population comprised all participants who received at least one dose of study treatment and had a baseline measurement or a post-randomization measurement for the analysis endpoint.|||Percent||95% Confidence Interval|Least Squares Mean
2634367|NCT01814722|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI)|DLQI is a 10-question dermatology-specific QOL questionnaire, which is calculated by summing the score of each question, resulting in a maximum of 30, and a minimum of 0. Higher scores mean the QOL is more impaired.|Baseline and Week 4 Follow-up|Analyses were not performed due to too few participants.||||||
2634368|NCT01814722|Secondary|Change From Baseline in HIV Symptom Index (HIV-SI)|HIV-SI measures the frequency and level of bothersome HIV and HIV treatment-related symptoms, including nervous symptoms (dizziness, somnolence, trouble remembering), gastrointestinal symptoms (nausea, gas/bloating, diarrhea) and pain (hand/foot, muscle/joint). The 20-item questionnaire asks whether respondents experienced any one of these symptoms within the past 4 weeks, and if they did, what the relative level of bother for each symptom was, based on a 5-point Likert scale. The maximum sum of scores is 80; the minimum is 0; with a higher score indicating greater symptom distress.|Baseline and Week 4 Follow-up|Analyses were not performed due to too few participants.||||||
2634369|NCT01814722|Secondary|Change From Baseline in Depression, Anxiety, and Stress Scale (DASS-21)|DASS-21 is comprised of questionnaires for three separate scales measuring Depression, Anxiety and Stress. The depression scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 28+, with higher scores indicating greater severity. The anxiety scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 20+, with higher scores indicating greater severity. The stress scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 37+, with higher scores indicating greater severity.|Baseline and Week 4 Follow-up|Analyses were not performed due to too few participants.||||||
2634370|NCT01814722|Primary|Medical Outcomes Study-HIV (MOS-HIV) Health Survey Scores|The MOS-HIV scale is a 35-item measure of health related quality of life (QOL) questionnaire which assesses 10 dimensions of health (general health perceptions, pain, physical functioning, role functioning, social functioning, mental health, energy/fatifue, cognitive function, health distress and QOL), as well as a single item to assess health transition. In addition to these subscales, a Physical Health Summary score (PHS) and a Mental Health Summary score (MHS) is calculated using a method where the summary scores are transformed to a standardized scale with a norm of 50 and a standard deviation of 10 in the sample in which the summary scores were developed. The subscales of the MOS-HIV are scored as summed rating scales ranging from a minimum of 0, to a maximum of 100, where higher scores indicate better health.|Week 4 Follow-up|Analyses were not performed due to too few participants.||||||
2634371|NCT01814696|Secondary|Minnesota Living With Heart Failure Questionnaire (MLHFQ) Total Summary Score|"Health-related quality of life is measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The questionnaire consists of 21 items that assess the impact of HF and HF treatment on key physical, emotional, and social dimensions of a patient's life during the past four weeks. Responses are coded from 0 = does not apply and 1 = very little to 5 = very much.~A higher score represents a greater negative HR-related impact on quality of life."|Baseline, end 3 months||||units on a scale||Standard Deviation|Mean
2634372|NCT01814696|Secondary|Hospitalization, Length of Stay (Days)||3 months|Intention to treat analysis.|||days||Standard Deviation|Mean
2634373|NCT01814696|Secondary|Number of Hospitalization Visits.||3 months|Intention to treat analysis.|||participants|||Number
2634374|NCT01814696|Secondary|Number of Emergency Department (ED) Visits.||3 months|Intention to treat analysis.|||participants|||Number
2634375|NCT01814696|Secondary|Number of Participants With 1 or More Hospitalizations.||3 months|Intention to treat analysis.|||participants|||Number
2634376|NCT01814696|Secondary|Number of Participants With 1 or More Emergency Department (ED) Visits.||3 months|Intention to treat analysis.|||participants|||Number
2634377|NCT01814696|Primary|Morisky Medication Adherence Survey, 8-Items (MMAS-8)|Subject reported medication adherence. The Morisky Medication Adherence Scale (MMAS) is a valid and reliable instrument that consists of 8 items that measure medication adherence. Responses are summed from the 8-items to yield 3 categories of adherence: 0 = high adherence, 1-2 = medium adherence, and 3-8 = low adherence.|3 months|Participants who completed questions on enrollment and closeout survey.|||participants|||Number
2634378|NCT01814670|Secondary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest|The Subject assessed the severity of his/her glabellar rhytides at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 14, Day 30, Day 90, Day 120|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1|||Percentage of Subjects|||Number
2634380|NCT01814670|Secondary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction|The subject assessed the severity of his/her glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 14, Day 30, Day 90, Day 120|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1 and had data at the noted time point|||Percentage of Subjects|||Number
2634381|NCT01814670|Secondary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction|The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 14, Day 90, Day 120|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1|||Percentage of Subjects|||Number
2634382|NCT01814670|Primary|Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction|The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.|Day 1, Day 30|Intent-to-Treat: all eligible subjects enrolled in the study who received study treatment (BOTOX®) at Day 1|||Percentage of Subjects|||Number
2634383|NCT01814553|Secondary|PFS|"Progression-free survival (PFS). PFS was defined as the time from the start of treatment to an event occurred. In the analyses for the PFS endpoint, an event was defined as disease progression or death, whichever occurred earlier. Data for patients who did not die or progress during the trial were censored at the time of afatinib discontinuation or transition to commercially available afatinib. Median PFS is estimated using Kaplan-Meier method.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1)."|Every 08 weeks during the first 6 months of treatment, and every 12 weeks thereafter until the end of treatment.|Treated Set|||Months||95% Confidence Interval|Median
2634384|NCT01814553|Secondary|Changes in Intensity of Diarrhea Over Time|Percentage of participants with grade 2 or higher diarrhea each week for the first 3 cycles of afatinib treatment|Up to 12 weeks (equivalent to 3 courses)|Treated set|||Percentage of participants|||Number
2634385|NCT01814553|Secondary|Duration of First Episode of Diarrhea Grade 2 or Higher|"Duration of first episode of diarrhea grade 2 or higher.~Please note that the nine patients experienced diarrhea episodes that were not managed according to the protocol specified afatinib treatment interruptions and dose reductions. No patients were excluded from the primary analysis."|From first drug administration until end of third treatment course, up to 84 days.|Treated set|||days||Standard Deviation|Mean
2634386|NCT01814553|Secondary|Time to Initial Onset of Diarrhea Grade 2 or Higher|Time to initial onset of diarrhea grade 2 or higher|From first drug administration until end of third treatment course, up to 84 days.|Treated set|||days||Standard Deviation|Mean
2634387|NCT01814553|Primary|Occurence of CTCAE Grade >= 2 Diarrhea|Overall incidence of patients who experienced diarrhea during the first three courses of afatinib treatment.|From first drug administration until 28 days after the end of third treatment course, up to 84 days.|Treated set|||Percentage of participants|||Number
2634388|NCT01814397|Other Pre-specified|Estradiol Concentration Assessments at Baseline and After 3 Months of Aromatase Inhibitor Therapy|Estradiol is being assessed using an ultrasensitive gas chromatography tandem mass spectroscopy-based assay. The lower limit of detection of the assay is 0.625 pg/ml. For patients whose serum estradiol concentrations were below the lower limit of detection, the value of 0.625 pg/ml was used to calculate the mean estradiol concentration and standard deviation at both baseline and 3 months.|Baseline, 3 months||||pg/ml||Standard Deviation|Mean
2634389|NCT01814397|Other Pre-specified|Mean Baseline Patient-reported Symptom Measures for Patients Who Were Persistent and Nonpersistent With Aromatase Inhibitor Therapy During the First 6 Months of Treatment|Patients completed 4 measures at baseline, before aromatase inhibitor therapy initiation. (1) Depression: Center for Epidemiologic Studies-Depression, scores 0-60, higher scores reflect more depression. (2) Pain: 7 day Pain Diary, scores 0-10, higher scores reflect more pain. (3) Fatigue: Multidimensional Fatigue Inventory, scores 4-20, higher scores reflect more fatigue. (4) Sleep: Medical Outcomes Study-Sleep, scores 0-100, higher scores reflect worse sleep. Persistence with aromatase inhibitor therapy was assessed at the 6 month timepoint. Mean baseline values for each measure were calculated for the cohort that persisted with aromatase inhibitor therapy and the cohort that was non-persistent.|Baseline patient-reported outcomes measures, 6 month persistence with therapy||||units on a scale||Standard Deviation|Mean
2634390|NCT01814397|Secondary|Mean Conditioned Pain Modulation Assessed at Baseline, 3 Months, and 6 Months|To assess conditioned pain modulation, pressure equivalent to the patient's Pain50 was applied to the non-dominant thumbnail for 30 seconds (test stimulus), and the patient rated the intensity of the pressure on a 0-100 pain scale at 10 second intervals. Ten minutes later pressure (conditioning stimulus) was continuously applied to the dominant thumbnail for 60 seconds at the same Pain50 intensity. After 30 seconds, the test stimulus was again applied to the non-dominant thumbnail for 30 seconds and the patient rated the intensity every 10 seconds. Conditioned pain modulation magnitude was calculated as the difference (second minus first) in the mean of the 3 pain ratings to the test stimulus applied prior to and during the conditioning stimulus. Conditioned pain modulation was assessed at baseline, 3 months, and 6 months. Change over that time period was assessed. Higher conditioned pain modulation values indicate less efficient conditioned pain modulation.|Baseline, 3 months, 6 months||||units on a scale (0-100 pain scale)||Standard Deviation|Mean
2634391|NCT01814397|Primary|Mean Pain50 Assessed at Baseline, 3 Months and 6 Months|Patients rated the intensity of each pressure sensation using a 0 to 100 numerical rating scale (0 = no pain, 100 = worst pain imaginable). Pain50 was defined as the amount of applied pressure in kilograms per square centimeter that evoked a pain intensity rating of 50 out of 100. Pain50 was assessed at baseline, 3 months, and 6 months. Change in Pain50 with estrogen depletion was determined.|Baseline, 3 months, 6 months||||kg/cm^2||Standard Deviation|Mean
2634647|NCT01811316|Secondary|Change From Baseline in Probing Depth (PD)|Periodontal pocket depth (PD) was determined with a periodontal probe at six sites per tooth rounded to the next lower whole mm.|4, 12 and 24 weeks|One subject was lost to follow up between 4 and 12 weeks.|||mm||Standard Deviation|Mean
2634392|NCT01814371|Secondary|Number of Participants Adhering to Decolonization Measures|Number of participants Adhering to decolonization measures. Defined as reported completion of at least 4 of the 5 assigned days (8 or more mupirocin applications and 4 or more bleach baths)|1 week|309 participants were assigned decolonization measures as part of the protocol. Of these 11 participants were lost to follow-up and never returned their adherence documents. The remaining 298 participants are analyzed.|||Participants|||Count of Participants
2634393|NCT01814371|Secondary|Number of Participants Reporting a Confirmed MRSA Infection Over the 12-month Longitudinal Study Period.|Number of participants reporting the development of a MRSA infection over the year of longitudinal follow-up that has been culture- and physician-confirmed through verification by medical record and culture report.|1 Year|416 of 474 participants were analyzed. The remaining 58 participants were lost to follow up for this time frame and outcome.|||Participants|||Count of Participants
2634394|NCT01814371|Secondary|Number of Participants Incurring Economic Burden of Performing Protocol|Number of participants incurring additional costs during their compliance with prescribed hygiene measures prescribed with the decolonization regimen: e.g., cost of containers of lotion or bars of soap discarded, cost of new pump or pour lotion or soap purchased, cost of new personal hygiene items or linens, cost of additional loads of laundry|1 month after enrollment|435 of 474 participants returned their cost of protocol documentation. This SECONDARY outcome is independent of study group, as the economic impact of the study in the overall study population is the outcome measure.|||Participants|||Count of Participants
2634395|NCT01814371|Secondary|Number of All Recovered S. Aureus Isolates With High-level Mupirocin Resistance|Number of all recovered S. aureus isolates resistant to mupirocin at the study visit before decolonization protocol and the study visit immediately after decolonization protocol|1 month|All participants swabbed before decolonization. 438 participants swabbed at 1 mo. follow-up (after decolonization) - remaining 36 lost to follow-up or unavailable for swabs at home visit. This SECONDARY outcome is independent of study group, as the impact of the study on mupirocin resistance in overall study population is the outcome measure.|||Isolates Analyzed/Recovered|Isolates Analyzed/Recovered||Count of Units
2634396|NCT01814371|Secondary|Number of Participants Who Report Development of Adverse Effects Occurring During Decolonization Period|Number of participants who report development of Nasal burning, itching, stinging, or runny nose or Skin itching, dry skin, or rash during the decolonization period.|1 week after enrollment|309 participants were assigned decolonization measures as part of the protocol. Of these 11 participants were lost to follow-up and never returned their adherence documents. 4 participants did not complete any part of the assigned decolonization measures. The remaining 294 participants are analyzed.|||Participants|||Count of Participants
2634397|NCT01814371|Secondary|Number of Participants Colonized With MRSA at 12 Months After Decolonization|Number of Participants Colonized with MRSA at the 12 Month longitudinal study visit|12 months after enrollment|407 of 474 participants were analyzed. The remaining 67 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit.|||Participants|||Count of Participants
2634398|NCT01814371|Secondary|Number of Participants Colonized With MRSA at 9 Months After Decolonization|Number of Participants Colonized with MRSA at the 9 Month longitudinal study visit|9 months after enrollment|422 of 474 participants were analyzed. The remaining 52 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit.|||Participants|||Count of Participants
2634399|NCT01814371|Secondary|Number of Participants Colonized With MRSA at 6 Months After Decolonization|Number of Participants Colonized with MRSA at the 6 Month longitudinal study visit|6 months after enrollment|431 of 474 participants were analyzed. The remaining 43 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit.|||Participants|||Count of Participants
2634400|NCT01814371|Secondary|Number of Participants Colonized With MRSA at 3 Months After Decolonization|Number of Participants Colonized with MRSA at the 3 Month longitudinal study visit|3 months after enrollment|433 of 474 participants were analyzed. The remaining 41 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit.|||Participants|||Count of Participants
2634401|NCT01814371|Secondary|Number of Participants Colonized With MRSA at 1 Month After Decolonization|Number of Participants Colonized with MRSA at the 1 Month longitudinal study visit|1 month after enrollment|438 of 474 participants were analyzed. The remaining 36 participants were lost to follow up for this time frame or were not available for swabs at the time of the home visit.|||Participants|||Count of Participants
2634402|NCT01814371|Secondary|Number of Participants With Incidence of SSTI at 12 Months After Decolonization|Cumulative Number of Participants with SSTI at any time during the 12 Months following Decolonization protocol|12 months after enrollment|417 of 474 participants were analyzed. The remaining 57 participants were lost to follow up for this time frame.|||Participants|||Count of Participants
2634403|NCT01814371|Secondary|Number of Participants With Incidence of SSTI at 9 Months After Decolonization|Cumulative Number of Participants with SSTI at any time during the 9 Months following Decolonization protocol|9 months after enrollment|433 of 474 participants were analyzed. The remaining 41 participants were lost to follow up for this time frame.|||Participants|||Count of Participants
2634404|NCT01814371|Secondary|Number of Participants With Incidence of SSTI at 6 Months After Decolonization|Cumulative Number of Participants with SSTI at any time during the 6 Months following Decolonization protocol|6 months after enrollment|434 of 474 participants were analyzed. The remaining 40 participants were lost to follow up for this time frame.|||Participants|||Count of Participants
2634405|NCT01814371|Secondary|Number of Participants With Incidence of SSTI at 1 Month After Decolonization|Cumulative Number of Participants with SSTI at any time during the 1 Month following Decolonization protocol|1 month after enrollment|449 of 474 participants were analyzed. The remaining 25 participants were lost to follow up for this time frame.|||Participants|||Count of Participants
2634406|NCT01814371|Primary|Number of Participants With Incidence of SSTI at 3 Months After Decolonization|Cumulative Number of Participants with SSTI at any time during the 3 Months following Decolonization protocol|3 months after enrollment|447 of 474 participants were analyzed. The remaining 27 participants were lost to follow up for this time frame.|||Participants|||Count of Participants
2634407|NCT01814332|Secondary|Safety, Measured by the Number of Subjects That Experienced an Adverse Event|The occurrence of adverse events will be recorded at the end of 6 weeks.|Baseline, Week 6||||participants|||Number
2634408|NCT01814332|Secondary|Efficacy, Measured by Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score|The MADRS is a ten-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with depressive disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. Change is the difference in scores between baseline and 6 weeks.|Baseline, Week 6||||Score on a scale||Standard Deviation|Mean
2634409|NCT01814332|Secondary|Efficacy, Measured by Response Rate of at Least 50% Improvement in CAPS Score at the End of 6 Weeks as Compared to Baseline|The number of participants that showed at least a 50% reduction in CAPS scores from their baseline visit at the end of 6 weeks were measured as having a response to the treatment. The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms).|Baseline, Week 6||||participants|||Number
2634410|NCT01814332|Primary|Efficacy, Measured by Change in the Clinician-Administered PTSD Scale (CAPS) Score|The CAPS is a semi-structured clinical interview providing a measure of the severity of PTSD symptoms. A severity score is calculated by summing the frequency and intensity scores for each of the 17 DSM-IV criteria symptoms. The severity of symptoms is rated on a scale from 0-4, where, 0 = Absent, 1 = Mild/subthreshold; 2 = Moderate/ threshold, 3 = Severe/markedly elevated and 4 = Extreme/ incapacitating. Scores may range from 0 (no symptoms) to 136 (severe symptoms). Change is the difference in scores between baseline and 6 weeks.|Baseline, 6 weeks|Intent to treat analysis was performed using maximum likelihood estimation with mixed models to include all observations.|||score on a scale||Standard Deviation|Mean
2634411|NCT01814241|Other Pre-specified|Change in Immunoglobin G4 (IgG4) to Peanut From Baseline Until Desensitization Food Challenge|The investigation of mechanistic changes that occur in the immune system dover the duration of the study - Immunoglobin G4 (IgG4) to peanut|44 weeks|Blood work was not able to be obtained from 1 of 16 evaluable subjects|||mg/dL of IgG4||Full Range|Median
2634412|NCT01814241|Other Pre-specified|Change in Peanut Specific Immunoglobin E (IgE) From Baseline Until Desensitization Food Challenge|The investigation of mechanistic changes that occur in the immune system over the duration of the study - Peanut specific immunoglobin E (IgE)|44 weeks|Blood work was not able to be obtained from 1 of 16 evaluable subjects|||kU/L of peanut-specific IgE||Full Range|Median
2634413|NCT01814241|Other Pre-specified|Change From Baseline in the Wheal Diameter, as Assessed by the Skin Prick Test (SPT) to Peanut|Allergic reactivity of mast cells is assessed by skin prick testing through measurement of the wheal diameter after exposure to peanut. This outcome measure reports the change in skin prick test wheal diameter from baseline through the end of the treatment period.|44 weeks||||mm||Full Range|Mean
2634414|NCT01814241|Secondary|Percentage of Subjects Who Maintain Desensitization Once OIT is Stopped|The percentage of subjects who maintain desensitization once the OIT is withdrawn at 1, 2, 3, and 4 week intervals.|4 weeks||||percentage of participants|||Number
2634415|NCT01814241|Primary|Percentage of Subjects Who Develop Desensitization|The percentage of peanut allergic subjects who develop desensitization as defined by being able to consume 5000mg of peanut protein during a double blind food challenge after completing a build-up phase of peanut OIT.|40 weeks||||percentage of participants|||Number
2634416|NCT01814137|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment. FPG was analysed on blood samples from fasting subjects which were analysed centrally.|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. One subject in each arm did not have FPG values from week 0.|||mmol/L||Standard Deviation|Mean
2634417|NCT01814137|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes|Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 00:01 and 05:59 hours inclusive. Confirmed hypoglycaemic episodes were defined as severe hypoglycaemic episodes and/or a measured PG below 3.1 mmol/L (below 56 mg/dL).|During 26 weeks of treatment|The SAS included all subjects receiving at least one dose of the investigational product.|||episodes|||Number
2634418|NCT01814137|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|"Confirmed hypoglycaemic episodes were defined as episodes that are either:~severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or~biochemically confirmed by a PG value of <3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia."|During 26 weeks of treatment|The SAS included all subjects receiving at least one dose of the investigational product.|||episodes|||Number
2634419|NCT01814137|Secondary|Incidence of Treatment Emergent Adverse Events (TEAEs)|A treatment emergent adverse event was defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last dose of the trial product.|During 26 weeks of treatment|Safety analysis set (SAS) included all subjects receiving at least one dose of the investigational product.|||number of events|||Number
2634420|NCT01814137|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
2634421|NCT01814046|Other Pre-specified|Count of Participants With Changes in Visual Symptoms|Visual symptoms (e.g., blurred) were evaluated and if changes had occurred from baseline, i.e. in visual acuity, an ophthalmologic consult was performed.|6 weeks (+/- 2 weeks)|One out of 24 subjects had blurred vision.|||Participants|||Count of Participants
2634422|NCT01814046|Secondary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|46 months and 12 days||||Participants|||Count of Participants
2665179|NCT01536093|Secondary|Concentration of Urinary Lactoferrin||1 week of age||||ug per g creatinine||Standard Deviation|Mean
2634423|NCT01814046|Primary|Percentage of Participants With Ocular Melanoma Treated With Young Tumor Infiltrating Lymphocytes (TIL) With or Without High Dose Aldesleukin With an Objective Response Rate of (Complete Response (CR) + Partial Response (PR))|Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|approximately 3 years||||percentage of participants||95% Confidence Interval|Number
2634424|NCT01813890|Secondary|Patient Global Impression of Change (PGI-C) Score at 72 Hours|The PGI-C is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. Higher scores indicate worsening.|Baseline (Day 1) and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.|||Percentage of participants|||Number
2634425|NCT01813890|Secondary|Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours|Participants rated pain relief on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. PRID is the sum of pain relief and PID at the same assessment time. SPRID was calculated as the time-weighted Sum of PRID scores over 12, 24, 48, and 72 hours. Total score ranges from -120 (worst) to 168 (best) for SPRID12, -240 (worst) to 336 (best) for SPRID24, -480 (worst) to 672 (best) for SPRID48, and -720 (worst) to 1008 (best) for SPRID72. A higher value of SPRID indicates greater pain relief.|12, 24, 48 and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.|||units on a scale||Standard Deviation|Mean
2634426|NCT01813890|Secondary|Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours|Participants rated pain relief on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum of pain relief scores up to Hour 12, 24, 48, and 72. Total score ranges from 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24, 0 (worst) to 192 (best) for TOTPAR48, and 0 (worst) to 288 (best) for TOTPAR72. A higher value of TOTPAR indicated greater pain relief.|12, 24, 48, and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.|||units on a scale||Standard Deviation|Mean
2634427|NCT01813890|Secondary|Sum of Pain Intensity Differences (SPID) Over 12, 24 and 72 Hours|Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 12, 24, and 72 hours. Total score ranges from -120 (worst) to 120 (best) for SPID12, -240 (worst) to 240 (best) for SPID24, -720 (worst) to 720 (best) for SPID72. A higher value of SPID indicates greater pain relief.|12, 24 and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.|||units on a scale||Standard Deviation|Mean
2634428|NCT01813890|Secondary|Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours|Response rate was defined as the percentage of participants with a 50 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|12, 24, 48 and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication.|||Percentage of Participants|||Number
2634429|NCT01813890|Secondary|Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48 and 72 Hours|Response rate was defined as the percentage of participants with a 30 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|12, 24, 48 and 72 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication.|||Percentage of Participants|||Number
2634430|NCT01813890|Secondary|Time to First Rescue Medication Use|Rescue medication was defined as any analgesic medication used for participants discontinued due to lack of efficacy (including those started at time of discontinuation) or analgesic medication used during the double-blind period for completed participants.|up to 48 hours|ITT analysis set, which included all randomly assigned participants with at least 1 dose of study medication.|||Hours||Inter-Quartile Range|Median
2634431|NCT01813890|Primary|Sum of Pain Intensity Difference (SPID) Over 48 Hours|Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.|48 hours|Intent-to-treat (ITT) analysis set, which included all randomly assigned participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method was used for missing values.|||units on a scale||Standard Deviation|Mean
2634432|NCT01813734|Secondary|Number of Participants With Adverse Events|The number of participants with grade 3 plus adverse events as assessed using Common Toxicology Criteria for Adverse Events (CTCAE 4) that were deemed to be possibly, probably, or definitely related to study treatment.|From the start of treatment until 30 days after the end of treatment (up to approximately 2 years)||||Participants|||Count of Participants
2634433|NCT01813734|Secondary|1 Year Overall Survival Rate|The number of participants surviving one year after study entry|1 year||||Participants|||Count of Participants
2634434|NCT01813734|Secondary|Median Progression-Free Survival|"The duration of time from study entry until disease progression (assessed using RECIST 1.1.) or death.~Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions denotes disease progression."|From study entry until disease progression or death, median duration of 3.8 months||||Months||95% Confidence Interval|Number
2634435|NCT01813734|Secondary|Disease Control Rate|"The number of participants that achieved either a partial or complete response or stable disease, assessed using Response Evaluation Criteria in Solid Tumors (RECIST v 1.1)~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study."|From the start of treatment until disease progression or death, up to approximately 2 years||||Participants|||Count of Participants
2634436|NCT01813734|Primary|Overall Response Rate|"The number of participants that achieved either a partial or complete response assessed using Response Evaluation Criteria in Solid Tumors (RECIST v 1.1)~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|From the start of treatment until disease progression or death, up to approximately 2 years||||Participants|||Count of Participants
2634437|NCT01813721|Secondary|Percentage of Participants With an Investigator-assessed FN Risk at or Above the Investigator Self-reported FN-risk Intervention Threshold Who Were Planned to Receive G-CSF PP|At Baseline investigators recorded the FN risk threshold score at which they would use G-CSF PP in their usual clinical practice. For each enrolled participant, the investigator documented their final estimated FN risk score as a percentage based on the participant's medical history and standard of care assessments (their routine practice for assessing this risk), and a decision as to whether G-CSF PP would be administered in Cycle 1.|At Baseline and at enrolment, prior to chemotherapy initiation.|Primary analysis set, participants with investigator-assessed FN risk at or above the investigator FN-risk intervention threshold|||percentage of participants|||Number
2634438|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Tumor Type|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only included subgroups with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
2634439|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Institution Type|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only included subgroups with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
2634440|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Number of Years in Clinical Practice in Oncology / Hematology|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only included subgroups with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
2634441|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Clinical Specialty|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only included subgroups with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
2634442|NCT01813721|Secondary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important by Country|"Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; analysis only includes subgroups with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
2635707|NCT01800162|Secondary|Number of Procedures (Lab Tests, Ultrasounds)|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|6 weeks|||||||
2634443|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Institution Type|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|Assessed at Baseline, prior to participant enrolment.|Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators.|||percentage of investigators|Investigators|95% Confidence Interval|Number
2634444|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Number of Years in Clinical Practice in Oncology / Hematology|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|Assessed at Baseline, prior to participant enrolment.|Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators.|||percentage of investigators|Investigators|95% Confidence Interval|Number
2634445|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia by Clinical Specialty|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rankt the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators.|Assessed at Baseline, prior to participant enrolment.|Primary analysis set - investigators (PASI); analysis was only performed for subgroups containing at least 40 investigators.|||percentage of investigators|Investigators|95% Confidence Interval|Number
2634446|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Tumor Type|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
2634447|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Institution Type|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
2634448|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
2634449|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set. Subgroup analyses were only performed in subgroups with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
2634450|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country|"For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.~To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.~ECOG = Eastern Cooperative Oncology Group."|At enrolment, prior to chemotherapy initiation.|Primary analysis set; subgroup analyses were only performed on subgroups (countries) with at least 100 participants.|||percentage of participants||95% Confidence Interval|Number
2634767|NCT01809262|Secondary|Peak FEV1 From 0 to 3 Hours|Peak FEV1 was defined as the maximum values of FEV1 from 0 to 3 hours.|0 to 3 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint|||L||Standard Error|Mean
2634451|NCT01813721|Secondary|Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important|For each participant, the investigator ranked the factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|At enrolment, prior to chemotherapy initiation.|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
2634452|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group.|Assessed at baseline, prior to participant enrolment.|Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators.|||percentage of investigators|Investigators|95% Confidence Interval|Number
2634453|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group.|Assessed at baseline, prior to participant enrolment.|Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators.|||percentage of investigators|Investigators|95% Confidence Interval|Number
2634454|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators.|Assessed at baseline, prior to participant enrolment.|Primary analysis set - investigators; analysis only includes subgroups with at least 40 investigators.|||percentage of investigators|Investigators|95% Confidence Interval|Number
2634455|NCT01813721|Secondary|Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|Assessed at baseline, prior to participant enrolment.|Primary analysis set - investigators|||percentage of investigators|Investigators|95% Confidence Interval|Number
2634456|NCT01813721|Primary|Percentage of Participants for Whom Each FN Risk Factor Was Ranked as Important|Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment was collected in this study. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.|At enrolment, prior to chemotherapy initiation.|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
2634457|NCT01813721|Primary|Percentage of Participants for Whom Age and Chemotherapy Regimen Were Ranked as an Important Risk Factor|Investigators ranked the risk factors they considered to be the most important when assessing the overall risk of febrile neutopenia for each participant. Only historical patient information recorded before the beginning of chemotherapy treatment were collected in this study. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.|At enrolment, prior to chemotherapy initiation|Primary analysis set which consists of all participants who satisfied the eligibility criteria and had at least one FN risk factor ranked by the investigator in their Subject Assessment.|||percentage of participants||95% Confidence Interval|Number
2634476|NCT01813435|Primary|Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI)|Number of Participants with a composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation.|2 year|Shown are the first event per event type for each patient only. Multiple events of the same type within the same patient are disregarded. Data were censored 730 days after index percutaneous coronary intervention.|||Participants|||Count of Participants
2636165|NCT01795105|Primary|Frequency (n) of Subjects With Adverse Event|Frequency (n) and Percentage(%) of subjects with Adverse event|Follow-up at least once from baseline to 6 weeks and at least 12weeks||||Participants|||Count of Participants
2634458|NCT01813721|Primary|Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN)|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group|Assessed at Baseline, prior to participant enrolment.|Primary analysis set - investigators (PASI), which consists of investigators who contributed participants to the primary analysis set (PAS).|||percentage of investigators|Investigators|95% Confidence Interval|Number
2634459|NCT01813721|Primary|Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia|During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall febrile neutropenia (FN) risk. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.|Baseline (prior to participant enrolment)|Primary analysis set - investigators (PASI), which consists of investigators who contributed participants to the primary analysis set (PAS).|||percentage of investigators|Investigators|95% Confidence Interval|Number
2634460|NCT01813474|Secondary|AUC at Steady State Following Multiple Dosing||Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose|Dose escalation part only. Two participants (1 in 200 mg bid and 1 in 300 mg bid) had no PK data due to early discontinuation prior to Day 15.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2634461|NCT01813474|Secondary|AUC Following Single Dosing||Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose|Dose escalation part only. One participant in 200 mg bid had no AUC data because AUC was not calculable for this participant.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2634462|NCT01813474|Secondary|Tmax Following Multiple Dosing||Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose|Dose escalation part only. Two participants (1 in 200 mg bid and 1 in 300 mg bid) had no PK data due to early discontinuation prior to Day 15.|||hour||Full Range|Median
2634463|NCT01813474|Secondary|Tmax Following Single Dosing||Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose|Dose escalation part only|||hour||Full Range|Median
2634464|NCT01813474|Secondary|Cmax Following Multiple Dosing||Day 15: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours at post-dose|Dose escalation part only. Two participants (1 in 200 mg bid and 1 in 300 mg bid) had no PK data due to early discontinuation prior to Day 15.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2634465|NCT01813474|Secondary|Cmax Following Single Dosing||Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours at post-dose|Dose escalation part only|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2634466|NCT01813474|Secondary|Number of Participants With Dose Limiting Toxicities|Dose Limiting Toxicities were defined as study specific events that is determined to be possibly or probably related to olaparib (as determined by the investigator) and occurring during the first cycle of treatment (28 days after the first dose), irrespective of whether the toxicity resolved.|From the start dose to 28 days after the first dose of study drug|All patients in only the dose escalation part who received olaparib and completed the safety follow-up through the dose-limiting toxicity (DLT) evaluation period (28 days), or who experienced a DLT.|||Participants|||Number
2634467|NCT01813474|Primary|Number of Participants With Adverse Events|An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. This was recorded if it happend from the start dose to 30 days after the last of study drug.|From the start dose to 30 days after the last dose of study drug||||Participants|||Number
2634468|NCT01813435|Secondary|Number of Participants With a Bleeding Academic Research Consortium (BARC) 3 or 5 Bleeding|"BARC definition. We only considered BARC 3 or 5 for this secondary safety endpoint.~Type 3: Clinical, laboratory, and/or imaging evidence of bleeding with:~Type 3a:~Overt bleeding + Hb drop of 3 to < 5 g/dL (provided Hb drop is related to bleed)~Any transfusion with overt bleeding~Type 3b:~Overt bleeding + Hb drop ≥5 g/dL (provided Hb drop is related to bleed)~Cardiac tamponade~Bleeding requiring surgical intervention (excluding dental/nasal/skin/haemorrhoid)~Bleeding requiring intravenous vasoactive agents~Type 3c:~Intracranial haemorrhage (does not include microbleeds or haemorrhagic transformation, does include intraspinal)~Subcategories confirmed by autopsy or imaging or lumbar puncture~Intraocular bleed compromising vision. Type 5: Fatal bleeding~Type 5a:~• Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious~Type 5b:~Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation"|2 year||||Participants|||Count of Participants
2634469|NCT01813435|Secondary|Number of Participants With a Definite Stent Thrombosis||2 year||||Participants|||Count of Participants
2634470|NCT01813435|Secondary|Number of Participants With a Myocardial Revascularisation||2 year||||Participants|||Count of Participants
2634471|NCT01813435|Secondary|Number of Participants With a Stroke||2 year||||Participants|||Count of Participants
2634472|NCT01813435|Secondary|Number of Participants With a Composite of All-cause Mortality, Stroke, or New Q-wave Myocardial Infarction|shown are the first event per event type for each patient only. Multiple events of the same type within the same patient are disregarded|2-year||||Participants|||Count of Participants
2634473|NCT01813435|Secondary|Number of Participants With New Q-wave Myocardial Infarction||2-year||||Participants|||Count of Participants
2634474|NCT01813435|Secondary|Number of Participants With Myocardial Infarction||2 year||||Participants|||Count of Participants
2634475|NCT01813435|Secondary|Number of Participants With All-cause Mortality||2-year||||Participants|||Count of Participants
2665180|NCT01536093|Secondary|Salivary IL-8 Concentration at 2 Weeks of Age||2 weeks of age||||ng/mL||Standard Deviation|Mean
2634477|NCT01813422|Secondary|Percentage of Participants With Regression in Total Atheroma Volume|"Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants.~Regression in TAV was defined as any reduction from baseline in TAV."|Baseline and week 78|Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set)|||percentage of participants||95% Confidence Interval|Number
2634478|NCT01813422|Secondary|Percentage of Participants With Regression in Percent Atheroma Volume|"Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma.~Regression in PAV was defined as any reduction from baseline in PAV."|Baseline and week 78|Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set)|||percentage of participants||95% Confidence Interval|Number
2634479|NCT01813422|Secondary|Change From Baseline in Total Atheroma Volume at Week 78|Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. Total atheroma volume (TAV) in a ≥ 40 mm segment of the targeted coronary artery was calculated as the average plaque area over the number of images that were evaluated by IVUS multiplied by the median vessel length to compensate for differences in segment length between participants.|Baseline and week 78|Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set)|||mm³||Standard Error|Least Squares Mean
2634480|NCT01813422|Primary|Change From Baseline in Percent Atheroma Volume at Week 78|Intravascular ultrasound (IVUS) was used to visualize the extent of atherosclerotic plaques in the coronary artery lumen. The extent of atherosclerosis was expressed as percent atheroma volume (PAV) in a ≥ 40 mm segment of one targeted (imaged) coronary artery, calculated as the percentage of the total vessel volume occupied by atheroma.|Baseline and week 78|Randomized participants who received at least 1 dose of study drug, with a baseline IVUS and an IVUS measurement conducted after week 52 (IVUS analysis set)|||percent atheroma volume||Standard Error|Least Squares Mean
2634481|NCT01813214|Secondary|Number of Participants With Tumor Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT and/or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|2 months||||Participants|||Count of Participants
2634482|NCT01813214|Primary|Time Course by Which Vemurafenib and Cobimetinib Increases T Cell Infiltration|CD4 T cell count per mm^2 of tumor|Day 1, Day 8, Day 15, Day 29||||CD4 T cell count per mm^2 of tumor||Standard Deviation|Mean
2634483|NCT01813214|Primary|Time Course by Which Vemurafenib and Cobimetinib Increases T Cell Infiltration|CD8 T cell count per mm^2 of tumor|Day 1, Day 8, Day 15, Day 29||||CD8 T cell count per mm^2 of tumor||Standard Deviation|Mean
2634484|NCT01813110|Secondary|Interleukin-6 (IL-6)|Change in the plasma concentration of TNF-α at 2 hours post endotoxin administration, after each 8 week intervention|2 hours post endotoxin administration, following each 8 week intervention||||pg/mL||Standard Error|Mean
2634485|NCT01813110|Secondary|Tumor Necrosis Factor-α (TNF-α)|Change in the plasma concentration of TNF-α at 2 hours post endotoxin administration, after each 8 week intervention|2 hours post endotoxin administration, following each 8 week intervention||||pg/mL||Standard Error|Mean
2634486|NCT01813110|Primary|Change in C Reactive Protein (CRP)|Change in blood levels of CRP at 24 hours post endotoxin administration, after each 8 week intervention|24 hours post endotoxin administration, following each 8 week intervention||||mg/L||Standard Error|Mean
2634487|NCT01813071|Secondary|Number and Percentage of Adult Participants With WRSS1 Shedding at Any Time After Vaccination|Prevalence and distribution of vaccine shedding was determined by quantitative culture and polymerase chain reaction (PCR). The latter measured the mean relative abundance of microbiota by 16S ribosomal ribonucleic acid (rRNA) gene sequence analysis of stool at baseline and post-vaccination days. PCR and stool results were reported as positive if a positive result was reported at any time during the testing period.|At any time (Day 0 to Day 84)|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected and analyzed.|||Participants|||Count of Participants
2634488|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in Ratio of Specific IgA to Total IgA Antibodies in Stool|Fecal antibody responses were defined as a four-fold rise for specific IgA (immunoglobulin A) or a four-fold rise for the ratio of specific over total IgA at any time point after immunization. Fecal antibody response to the WRSS1 was evaluated by assessing Fecal IgA antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in ELISA assays at Days -1, 7, 28, 35, 56, 63, and 84 . For those participants with a zero titer at baseline fold-rise was defined as the follow-up titer.|At any time (Day 7 to Day 84)|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected. Participants analyzed (n) were those for whom data was available. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had stool collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634489|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in Ratio of Specific IgA to Total IgA Antibodies in Stool|Fecal antibody responses were defined as a four-fold rise for specific IgA (immunoglobulin A) or a four-fold rise for the ratio of specific over total IgA at any time point after immunization. Fecal antibody response to the WRSS1 was evaluated by assessing Fecal IgA antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in ELISA assays at Days -1, 7, 28, 35, 56, 63, and 84 . For those participants with a zero titer at baseline fold-rise was defined as the follow-up titer.|Day 84|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected. Participants analyzed (n) were those for whom data was available. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had stool collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634490|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in Ratio of Specific IgA to Total IgA Antibodies in Stool|Fecal antibody responses were defined as a four-fold rise for specific IgA (immunoglobulin A) or a four-fold rise for the ratio of specific over total IgA at any time point after immunization. Fecal antibody response to the WRSS1 was evaluated by assessing Fecal IgA antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in ELISA assays at Days -1, 7, 28, 35, 56, 63, and 84 . For those participants with a zero titer at baseline fold-rise was defined as the follow-up titer.|Day 63|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected. Participants analyzed (n) were those for whom data was available. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had stool collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634491|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in Ratio of Specific IgA to Total IgA Antibodies in Stool|Fecal antibody responses were defined as a four-fold rise for specific IgA (immunoglobulin A) or a four-fold rise for the ratio of specific over total IgA at any time point after immunization. Fecal antibody response to the WRSS1 was evaluated by assessing Fecal IgA antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in ELISA assays at Days -1, 7, 28, 35, 56, 63, and 84 . For those participants with a zero titer at baseline fold-rise was defined as the follow-up titer.|Day 56|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected. Participants analyzed (n) were those for whom data was available. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had stool collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634492|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in Ratio of Specific IgA to Total IgA Antibodies in Stool|Fecal antibody responses were defined as a four-fold rise for specific IgA (immunoglobulin A) or a four-fold rise for the ratio of specific over total IgA at any time point after immunization. Fecal antibody response to the WRSS1 was evaluated by assessing Fecal IgA antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in ELISA assays at Days -1, 7, 28, 35, 56, 63, and 84 . For those participants with a zero titer at baseline fold-rise was defined as the follow-up titer.|Day 35|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected. Participants analyzed (n) were those for whom data was available. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had stool collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634493|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in Ratio of Specific IgA to Total IgA Antibodies in Stool|Fecal antibody responses were defined as a four-fold rise for specific IgA (immunoglobulin A) or a four-fold rise for the ratio of specific over total IgA at any time point after immunization. Fecal antibody response to the WRSS1 was evaluated by assessing Fecal IgA antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in ELISA assays at Days -1, 7, 28, 35, 56, 63, and 84 . For those participants with a zero titer at baseline fold-rise was defined as the follow-up titer.|Day 28|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected. Participants analyzed (n) were those for whom data was available. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had stool collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634494|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in Ratio of Specific IgA to Total IgA Antibodies in Stool|Fecal antibody responses were defined as a four-fold rise for specific IgA (immunoglobulin A) or a four-fold rise for the ratio of specific over total IgA at any time point after immunization. Fecal antibody response to the WRSS1 was evaluated by assessing Fecal IgA antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in ELISA assays at Days -1, 7, 28, 35, 56, 63, and 84 . For those participants with a zero titer at baseline fold-rise was defined as the follow-up titer.|Day 7|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and stool was collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634495|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Stool|The mucosal immune response to the WRSS1 was evaluated by assessing Fecal IgA (immunoglobulin A) antibody responses in stool to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in ELISA assays, at Days -1, 7, 28, 35, 56, 63, and 84. 4-fold increases of LPS and invaplex-specific IgA in stool beyond baseline mean + 3 SD (standard deviation) were determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer. Pro-inflammatory cytokines (IL-1β, IL-8, TNF-α and IFN-γ) were measured in stool extracts using commercially available ELISA kits.|At any time (Day 7 to Day 84)|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and stool was collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634496|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Stool|The mucosal immune response to the WRSS1 was evaluated by assessing Fecal IgA (immunoglobulin A) antibody responses in stool to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in ELISA assays, at Days -1, 7, 28, 35, 56, 63, and 84. 4-fold increases of LPS and invaplex-specific IgA in stool beyond baseline mean + 3 SD (standard deviation) were determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer. Pro-inflammatory cytokines (IL-1β, IL-8, TNF-α and IFN-γ) were measured in stool extracts using commercially available ELISA kits.|Day 84|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and stool was collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634547|NCT01813019|Secondary|Y-BOCS Reduction in Total Score From Baseline|If a subject demonstrates at least 25% reduction in total Y-BOCS from Baseline then they will be classed as a responder whereas if a subject has a reduction in Y-BOCS of less than 25% then they will be categorized as a nonresponder.|16 weeks|The study was terminated due to an interim analysis of the primary efficacy outcome. Study was prematurely terminated at the time of the first Interim Analysis (IA) as the study did not meet its primary efficacy objective therefore secondary objective was not measured.||||||
2634497|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Stool|The mucosal immune response to the WRSS1 was evaluated by assessing Fecal IgA (immunoglobulin A) antibody responses in stool to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in ELISA assays, at Days -1, 7, 28, 35, 56, 63, and 84. 4-fold increases of LPS and invaplex-specific IgA in stool beyond baseline mean + 3 SD (standard deviation) were determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer. Pro-inflammatory cytokines (IL-1β, IL-8, TNF-α and IFN-γ) were measured in stool extracts using commercially available ELISA kits.|Day 63|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and stool was collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634498|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Stool|The mucosal immune response to the WRSS1 was evaluated by assessing Fecal IgA (immunoglobulin A) antibody responses in stool to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in ELISA assays, at Days -1, 7, 28, 35, 56, 63, and 84. 4-fold increases of LPS and invaplex-specific IgA in stool beyond baseline mean + 3 SD (standard deviation) were determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer. Pro-inflammatory cytokines (IL-1β, IL-8, TNF-α and IFN-γ) were measured in stool extracts using commercially available ELISA kits.|Day 56|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and stool was collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634499|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Stool|The mucosal immune response to the WRSS1 was evaluated by assessing Fecal IgA (immunoglobulin A) antibody responses in stool to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in ELISA assays, at Days -1, 7, 28, 35, 56, 63, and 84. 4-fold increases of LPS and invaplex-specific IgA in stool beyond baseline mean + 3 SD (standard deviation) were determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer. Pro-inflammatory cytokines (IL-1β, IL-8, TNF-α and IFN-γ) were measured in stool extracts using commercially available ELISA kits.|Day 35|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and stool was collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634500|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Stool|The mucosal immune response to the WRSS1 was evaluated by assessing Fecal IgA (immunoglobulin A) antibody responses in stool to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in ELISA assays, at Days -1, 7, 28, 35, 56, 63, and 84. 4-fold increases of LPS and invaplex-specific IgA in stool beyond baseline mean + 3 SD (standard deviation) were determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.Pro-inflammatory cytokines (IL-1β, IL-8, TNF-α and IFN-γ) were measured in stool extracts using commercially available ELISA kits.|Day 28|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and stool was collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634501|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Stool|The mucosal immune response to the WRSS1 was evaluated by assessing Fecal IgA (immunoglobulin A) antibody responses in stool to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in enzyme-linked immunosorbent assay (ELISA) assays, at Days -1, 7, 28, 35, 56, 63, and 84. 4-fold increases of LPS and invaplex-specific IgA in stool beyond baseline mean + 3 SD (standard deviation) were determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer. Pro-inflammatory cytokines (Interleukin 1 beta (IL-1β), Interleukin 8 (IL-8), tumor necrosis factor alpha (TNF-α) and Interferon gamma (IFN-γ)) were measured in stool extracts using commercially available ELISA kits.|Day 7|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom stool was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and stool was collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634502|NCT01813071|Secondary|Number and Percentage of Adult Participants With a 2-fold Rise From Baseline in IgA and IgG Antibodies in ASC|Antibody Secreting Cell (ASC) by ELISPOT assay responses for IgA (immunoglobulin A) and IgG (immunoglobulin B) ASCs specific for LPS (lipopolysaccharide) and Invaplex were determined at Days -1, 7, 35, and 63. 2-fold increases of LPS and Invaplex specific IgA and IgG in ASC beyond baseline mean + 3 Standard Deviation (SD) were determined. Positive response was ≥8 spots per 1 million peripheral blood mononuclear cells.|At any time (Day 7 to Day 63)|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 received a single dose of study vaccine and had research blood collected only on Day 7.|||Participants|||Count of Participants
2634503|NCT01813071|Secondary|Number and Percentage of Adult Participants With a 2-fold Rise From Baseline in IgA and IgG Antibodies in ASC|Antibody Secreting Cell (ASC) by ELISPOT assay responses for IgA (immunoglobulin A) and IgG (immunoglobulin B) ASCs specific for LPS (lipopolysaccharide) and Invaplex were determined at Days -1, 7, 35, and 63. 2-fold increases of LPS and Invaplex specific IgA and IgG in ASC beyond baseline mean + 3 Standard Deviation (SD) were determined. Positive response was ≥8 spots per 1 million peripheral blood mononuclear cells.|Day 63|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 received a single dose of study vaccine and had research blood collected only on Day 7.|||Participants|||Count of Participants
2634565|NCT01812057|Secondary|Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics|"Patients who had experienced Postoperative nausea either reported postoperative nausea scores at 2, 24 and 48 hours from >0, reported an episode of vomiting or received an antiemetic were recorded as experiencing PONV.~Patients who received at least one rescue antiemetic postoperatively were recorded as requiring a rescue antiemetic"|2, 24 and 48 hours from PACU admission||||Participants|||Count of Participants
2665181|NCT01536093|Secondary|Salivary TGF-beta 1 Concentration at 2 Week of Age||2 week of age||||ug/mL||Standard Deviation|Mean
2634504|NCT01813071|Secondary|Number and Percentage of Adult Participants With a 2-fold Rise From Baseline in IgA and IgG Antibodies in ASC|Antibody Secreting Cell (ASC) by ELISPOT assay responses for IgA (immunoglobulin A) and IgG (immunoglobulin B) ASCs specific for LPS (lipopolysaccharide) and Invaplex were determined at Days -1, 7, 35, and 63. 2-fold increases of LPS and Invaplex specific IgA and IgG in ASC beyond baseline mean + 3 Standard Deviation (SD) were determined. Positive response was ≥8 spots per 1 million peripheral blood mononuclear cells.|Day 35|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 received a single dose of study vaccine and had research blood collected only on Day 7.|||Participants|||Count of Participants
2634505|NCT01813071|Secondary|Number and Percentage of Adult Participants With a 2-fold Rise From Baseline in IgA and IgG Antibodies in ASC|Antibody Secreting Cell (ASC) by ELISPOT assay responses for IgA (immunoglobulin A) and IgG (immunoglobulin B) ASCs specific for LPS (lipopolysaccharide) and Invaplex were determined at Days -1, 7, 35, and 63. 2-fold increases of LPS and Invaplex specific IgA and IgG in ASC beyond baseline mean + 3 Standard Deviation (SD) were determined. Positive response was ≥8 spots per 1 million peripheral blood mononuclear cells.|Day 7|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 received a single dose of study vaccine and had research blood collected only on Day 7.|||Participants|||Count of Participants
2634506|NCT01813071|Secondary|Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|At any time (Day 7 to Day 84)|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634507|NCT01813071|Secondary|Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 84|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634508|NCT01813071|Secondary|Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 63|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634509|NCT01813071|Secondary|Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 56|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634510|NCT01813071|Secondary|Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 35|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634511|NCT01813071|Secondary|Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 28|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634512|NCT01813071|Secondary|Number and Percentage of Child Participants With a 4-fold Rise From Baseline in (Immunoglobulin M) IgM Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 7|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634513|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|At any time (Day 7 to Day 84)|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634514|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 84|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634515|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 63|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634516|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 56|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634517|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 35|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634518|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 28|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634566|NCT01812057|Secondary|Need for Intraoperative Analgesic Supplementation|Need for intraoperative analgesic supplementation was determined by patients who required intraoperative analgesics for pain|From spinal anesthesia placement to end of surgery, approximately 70 minutes||||Participants|||Count of Participants
2634567|NCT01812057|Secondary|Incidence of Postoperative Pruritus|"Incidence of postoperative pruritus was calculated based on their postoperative pruritus scores measured at 2 hours, 24 hours and 48 hours. Median of the scores recorded at three time points was calculated.~If median score >0 then patient experienced postoperative pruritus."|48 hours from admission to PACU||||Participants|||Count of Participants
2634519|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 7|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634520|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|At any time (Day 7 to Day 84)|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634521|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 84|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634522|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 63|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634523|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 56|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634524|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 35|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634525|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 28|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634568|NCT01812057|Secondary|Incidence of Intraoperative Pruritus|pruritus was defined as patients reporting a pruritus score of greater than o on a numerical rating scale with o=no pruritus and 10= worst pruritus|From spinal anesthesia placement to end of surgery, approximately 70 minutes|No data was collected on intraoperative pruritus on any participants.||||||
2634672|NCT01811186|Secondary|The Change of Pain Intensity Scores(NRS) From Baseline After 6 Weeks Treatment With the Study.|Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline to 6weeks. NRS score was measured from 0 (No pain) to 10(worst pain imaginable).|6 weeks|ITT analysis set: 258|||units on a scale||Standard Deviation|Mean
2634526|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in Serum|The systemic immune response to WRSS1 was evaluated by assessing the IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex in serum samples at Days -1, 7, 28, 35, 56, 63 and 84. Serotype-speciﬁc LPS from the Walter Reed Army Institute was used to coat the ELISA plates. A ≥4-fold rise in serum antibody titers was considered signiﬁcant. Fold rise is the ratio of follow-up titer/baseline titer. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 7|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7 and Day 28.|||Participants|||Count of Participants
2634527|NCT01813071|Secondary|Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in ALS|The mucosal immune response to WRSS1 was evaluated by assessing specific IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- and Invaplex-specific IgM responses from circulating lymphocytes. Proportion of children with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|At any time (Day 7 to Day 63)|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.|||Participants|||Count of Participants
2634528|NCT01813071|Secondary|Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in ALS : LPS|The mucosal immune response to WRSS1 was evaluated by assessing specific IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS-specific IgM responses from circulating lymphocytes. Proportion of children with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 63|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.|||Participants|||Count of Participants
2634529|NCT01813071|Secondary|Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in ALS: Invaplex|The mucosal immune response to WRSS1 was evaluated by assessing specific IgM (immunoglobulin M) antibody responses to S. sonnei 2a Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine Invaplex-specific IgM responses from circulating lymphocytes. Proportion of children with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 63|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.|||Participants|||Count of Participants
2634530|NCT01813071|Secondary|Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in ALS: LPS|The mucosal immune response to WRSS1 was evaluated by assessing specific IgM (immunoglobulin M) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- specific IgM responses from circulating lymphocytes. Proportion of children with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 35|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.|||Participants|||Count of Participants
2634531|NCT01813071|Secondary|Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in ALS: Invaplex|The mucosal immune response to WRSS1 was evaluated by assessing specific IgM (immunoglobulin M) antibody responses to S. sonnei 2a Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine Invaplex-specific IgM responses from circulating lymphocytes. Proportion of children with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 35|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.|||Participants|||Count of Participants
2634532|NCT01813071|Secondary|Number and Percentage of Child Participants With a 4-fold Rise From Baseline in IgM Antibodies in ALS|The mucosal immune response to WRSS1 was evaluated by assessing specific immunoglobulin M (IgM) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- and Invaplex-specific IgM responses from circulating lymphocytes. Proportion of children with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 7|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.|||Participants|||Count of Participants
2635083|NCT01807624|Secondary|SpO2 Increase of > 5% on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||participants|||Number
2634533|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in ALS|The mucosal immune response to WRSS1 was evaluated by assessing specific IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- and Invaplex-specific IgG responses from circulating lymphocytes. Proportion of participants with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|At any time (Day 7 to Day 63)|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.|||Participants|||Count of Participants
2634534|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in ALS: Lipopolysaccharide (LPS)|The mucosal immune response to WRSS1 was evaluated by assessing specific IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS-specific IgG responses from circulating lymphocytes. Proportion of participants with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 63|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.|||Participants|||Count of Participants
2634535|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in ALS: Invaplex|The mucosal immune response to WRSS1 was evaluated by assessing specific IgG (immunoglobulin G) antibody responses to S. sonnei 2a Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine Invaplex-specific IgG responses from circulating lymphocytes. Proportion of participants with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 63|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.|||Participants|||Count of Participants
2634536|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgG Antibodies in ALS|The mucosal immune response to WRSS1 was evaluated by assessing specific IgG (immunoglobulin G) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- and Invaplex-specific IgG responses from circulating lymphocytes. Proportion of participants with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 35|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.|||Participants|||Count of Participants
2634537|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in Immunoglobulin G (IgG ) IgG Antibodies in ALS|The mucosal immune response to WRSS1 was evaluated by assessing specific immunoglobulin G (IgG ) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- and Invaplex-specific IgG responses from circulating lymphocytes. Proportion of participants with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 7|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.|||Participants|||Count of Participants
2634538|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in ALS|The mucosal immune response to WRSS1 was evaluated by assessing specific IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- and Invaplex-specific IgA responses from circulating lymphocytes. Proportion of participants with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|At any time (Day 7 to Day 63)|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.|||Participants|||Count of Participants
2634539|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in ALS|The mucosal immune response to WRSS1 was evaluated by assessing specific IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- and Invaplex-specific IgA responses from circulating lymphocytes. Proportion of participants with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer..|Day 63|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.|||Participants|||Count of Participants
2634540|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in IgA Antibodies in ALS|The mucosal immune response to WRSS1 was evaluated by assessing specific IgA (immunoglobulin A) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and Invaplex using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- and Invaplex-specific IgA responses from circulating lymphocytes. Proportion of participants with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 35|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.|||Participants|||Count of Participants
2634541|NCT01813071|Secondary|Number and Percentage of Participants With a 4-fold Rise From Baseline in Immunoglobulin A (IgA) Antibodies in Antibody Titers in Lymphocyte Supernatant (ALS)|The mucosal immune response to WRSS1 was evaluated by assessing specific immunoglobulin A (IgA) antibody responses to S. sonnei 2a LPS (lipopolysaccharide) and a novel composition comprising invasin proteins and LPS from gram-negative bacteria (Invaplex) using the 'antibodies in lymphocyte supernatant' (ALS) assay on culture supernatants of cultured peripheral blood mononuclear cells from different study days before and after vaccination to determine LPS- and Invaplex-specific IgA responses from circulating lymphocytes. Proportion of participants with a >= 4-fold increase in antibody titer beyond baseline (mean + 3 standard deviation) was determined. For those with a zero titer at baseline, fold-rise was defined as the follow-up titer.|Day 7|The overall number of participants analyzed (N) were those who received at least one study vaccination and for whom research blood was collected and analyzed. Adult Cohort A1 and Child Cohort B1 received a single dose of study vaccine and had research blood collected only on Day 7.|||Participants|||Count of Participants
2634542|NCT01813071|Primary|Number and Percentage of Participants With Any Unsolicited AEs and SAEs Judged as Having a Reasonable Possibility That the Study Product Caused the Event|Adverse event (AE) was defined as any untoward medical occurrence in humans, whether or not considered drug related, that occurs during the conduct of a clinical trial. A Serious Adverse Event (SAE) , including serious suspected adverse reaction or serious adverse reaction as determined by the Investigator or the sponsor, was any event that results in any of the following outcomes: Inpatient hospitalization or prolongation of existing hospitalization , life-threatening AE that in the opinion of the investigator or sponsor put the participant at immediate risk of death, persistent or significant incapacity or substantial disruption, congenital abnormality or birth defect, a medically important event that may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed or death. Causality of the AE/SAE to the study drug was assessed by the Investigator as reasonable possibility that the study product caused the reported event.|SAEs at any time and AEs after any vaccination until Day 168 (Cohort A1, B1) and Day 224 (all other Cohorts).|All participants who had been exposed to at least one dose of study product were included in the primary analysis for safety. Adult Cohort A1 and Child Cohort B1 only received a single dose of study vaccine.|||Participants|||Count of Participants
2634543|NCT01813071|Primary|Number and Percentage of Participants With Solicited Systemic and Intestinal Reactions|Maximum severity per participant of any systemic or any gastrointestinal reactogenicity recorded within 7 days of any vaccination is reported. Solicited Systemic reactogenicity events assessed included fever, headache, malaise, generalized myalgia, arthralgia, chills, reactive arthritis and decreased appetite. Intestinal solicited reactogenicity events assessed included abdominal cramps, abdominal pain, nausea, vomiting, loose stool, diarrhea, dysentery, bloating, excess flatulence and constipation. Diarrhea and dysentery were assessed both during inpatient (first three day period post-vaccination) and outpatient ( post-vaccination days 4-7) periods post-vaccination 1. Vaccinations 2 and 3 did not have an inpatient admission period for any participants. Diarrhea severity was determined on the basis of stool number, grading and stool weight during the inpatient period and by stool number and grading only during the outpatient period.|Day 0 through Day 7 after any vaccination|All participants who had been exposed to at least one dose of study product were included in the primary analysis for safety.|||Participants|||Count of Participants
2634544|NCT01813071|Primary|Number and Percentage of Participants With Any Non-serious Unsolicited Adverse Events|Based on subject count over all non-serious adverse events. An Adverse event was defined as any untoward medical occurrence in humans, whether or not considered drug related, that occurred during the conduct of a clinical trial. Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that was considered clinically significant by the study investigator, was considered an AE. This definition also included an exacerbation or worsening of pre-existing conditions or events, inter-current illnesses, injuries, or vaccine or drug interaction, or worsening of abnormal clinical laboratory values. All AEs were assessed by the clinician using a protocol defined grading system.|Day -1(admission day) through 6 months (Day 224 +/- 14 days) after the third vaccination for Cohorts A2,A3, B2, B3, B4, and after the first vaccination (Day 168 +/- 14 days) for Cohorts A1 and B1.|All participants who had been exposed to at least one dose of study product were included in the primary analysis for safety.|||Participants|||Count of Participants
2634545|NCT01813071|Primary|Number and Percentage of Participants With Serious Adverse Events (SAEs)|Based on maximum severity per participant over all serious adverse events (SAEs) within 6 months of any vaccination. A Serious Adverse Event, including serious suspected adverse reaction or serious adverse reaction as determined by the Investigator or the sponsor, was any event that results in any of the following outcomes: Inpatient hospitalization or prolongation of existing hospitalization , life-threatening AE that in the opinion of the investigator or sponsor put the participant at immediate risk of death, persistent or significant incapacity or substantial disruption, congenital abnormality or birth defect, a medically important event that may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed or death.|Day -1(admission day) through 6 months (Day 224 +/- 14 days) after the third vaccination for Cohorts A2,A3, B2, B3, B4, and after the first vaccination (Day 168 +/- 14 days) for Cohorts A1 and B1.|All participants who had been exposed to at least one dose of study product were included in the primary analysis for safety.|||Participants|||Count of Participants
2634546|NCT01813058|Primary|Perioperative Blood Loss|Perioperative blood loss (during operation and for entire hospital admission)|perioperarively - during entire hospital admission||||mL||Standard Deviation|Mean
2634548|NCT01813019|Primary|Yale - Brown Obsessive Compulsive Scale (Y-BOCS) Absolute Change From Baseline at Week 17 (End of 16-week Dosing).|"The Y-BOCS is a 10 item clinician-rated scale used to both determine the severity of OCD and to monitor symptom improvement throughout the course of the study. The Y-BOCS, specifically measures the severity of symptoms of OCD without being biased towards the type of obsessions or compulsions present. The scale includes questions about the amount of time spent on, how much impairment or distress experienced from, and how much resistance and control over these obsessive thoughts and compulsions. Each item is rated from 0 (no symptoms) to 4 (extreme symptoms) and yields a total possible score range from 0 to 40, with the following ranges indicating degree of severity:~0-7 = sub-clinical 8-15 = mild 16-23 = moderate 24-31 = severe 32-40 = extreme Baseline was compared to week 17 (end of week 16 dosing) to produce an absolute change."|baseline, week 17|Pharmacodynamics (PD) analysis set only participants that were analyzed at baseline and Week 17. Positive change from baseline indicates a decrease in symptom severity|||Scores on a scale||Standard Error|Least Squares Mean
2634549|NCT01812837|Primary|Actinic Keratoses Reduction Percent||one month after treatment||||percentage||Standard Deviation|Mean
2634550|NCT01812707|Secondary|Absolute Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) Ratio at Week 12 - On-Treatment Analysis|Adjusted LS mean and standard errors were estimated using the same ANCOVA as for primary endpoint.|From Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post baseline on-treatment value of ApoB/ApoA-1 ratio analyzed.|||ratio||Standard Error|Least Squares Mean
2634551|NCT01812707|Secondary|Percent Change From Baseline in Fasting Triglycerides and Lipoprotein (a) at Week 12 - On-Treatment Analysis|Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (inter-quartile range).|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post baseline on-treatment value of Fasting Triglycerides and Lipoprotein (a) analyzed.|||percent change||Inter-Quartile Range|Median
2634552|NCT01812707|Secondary|Percent Change From Baseline in Total Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C), Non-HDL-C, and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|Participants of the mITT population with one baseline and at least one post baseline on-treatment value of lipid parameters analyzed.|||percent change||Standard Error|Least Squares Mean
2634553|NCT01812707|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis||Week 12 (LOCF)|mITT population.|||percentage of participants|||Number
2634554|NCT01812707|Secondary|Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|mITT population.|||mg/dL||Standard Error|Least Squares Mean
2634555|NCT01812707|Secondary|Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.|Baseline to Week 12 (LOCF)|mITT population.|||mmol/L||Standard Error|Least Squares Mean
2634556|NCT01812707|Primary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational product (IP) injection up to 21 days after last IP injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward [LOCF] method.|Baseline to Week 12 (LOCF)|Modified Intent-To-Treat (mITT) population included all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2634557|NCT01812681|Secondary|Sepsis|Association of vitamin D level with sepsis|four weeks||||participants|||Number
2634558|NCT01812681|Primary|Respiratory Distress Syndrome|The association of vitamin D level with respiratory distress syndrome|three days||||participants|||Number
2634559|NCT01812655|Secondary|Engagement With Distraction and Belief in Distraction's Efficacy|"For Engagement with Distraction,VR and PD participants were asked on the Post-testing Questionnaire: Were you able to pay attention to the DVD or to the VR during your burn treatment? (1=could not pay attention at all; 5=totally absorbed at all times)~For Belief in Distraction's Efficacy, VR and PD participants were asked on the Post-Procedure Questionnaire: I believe that the distraction lessened my pain during my burn treatment today. (on a scale of 1=Distraction did not help to lessen my pain at all; 5=Distraction completely helped to lessen my pain at all times)"|Post-procedure (approximately 30-75 minutes)||||scores on a scale||Standard Deviation|Mean
2634560|NCT01812655|Secondary|Desire for Distraction|"Participants were asked I wanted to be distracted from during my treatment today. (Agree-Disagree) from the Post-Procedure Questionnaire"|Post-procedure (approximately 30-75 minutes)||||participants|||Number
2634561|NCT01812655|Primary|Self-reported Wound Care Procedure Pain Score|The acute pain experienced during the burn wound care procedure was measured on a 100mm visual analog scale called the Adolescent Pediatric Pain Tool through self-report by adolescents ages 10-17 years receiving outpatient burn wound care. The scale ranges from 0mm (No Pain) to 100mm (Worst Pain).|Within the first 20 minutes following completion of the burn wound care procedure|Intention to treat|||mm||95% Confidence Interval|Least Squares Mean
2634562|NCT01812473|Primary|Differences in Overall Protein Binding in the Presence of Different Plasma Albumin Concentrations.|At steady state plasma concentrations of voriconazole, a plasma sample is taken to determine the overall protein binding of voriconazole. Equilibrium dialysis is used, followed by liquid chromatography-mass spectrometry.|At steady state plasma concentration of voriconazole (after day 4 of therapy)||||% of plasma protein binding|Participants|Inter-Quartile Range|Median
2634563|NCT01812057|Secondary|Blood Pressure Measurements Obtained by the Standard of Care Non-invasive Blood Pressure Monitor Compared With the Continuous Noninvasive Arterial Pressure (CNAP)||Intraoperatively|No data was collected intraoperatively using CNAP on any participants.||||||
2634564|NCT01812057|Secondary|Incidence of Wound Complications|Patients were assessed for signs of surgical wound inspection by the obstetric team following surgery|24 hours from PACU admission||||Participants|||Count of Participants
2634569|NCT01812057|Secondary|Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics.|Incidence of intraoperative nausea and vomiting and need for rescue antiemetics were recorded during surgery. Patient who reported a nausea score on a 11 point NRS where 0=no nausea and 10 = the worse nausea possible. Patients who retched or vomited were reported to have vomited. Patients receiving any antiemetic during surgery were recorded as those requesting ( needing) rescue antiemetic.|From spinal anesthesia placement to end of surgery, approximately 70 minutes||||Participants|||Count of Participants
2634570|NCT01812057|Secondary|Pain Scores Between MTS Groups|Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0=no pain and 100=worst pain possible) after the 1st and 11th tap. A difference < 1 was recorded as MTS negative, and a difference > or = 1 was recorded as MTS positive.|24 hours after PACU admission||||units on a scale||Inter-Quartile Range|Median
2634571|NCT01812057|Secondary|Incidence of Chronic Persistent Pain at 6 Months|Patients answered a questionnaire at 6 months to determine whether they still had persistent surgical site pain 6 months following surgery|6 months from the day of surgery|Analysis was based on available data from both arms including 25 patients. Data was missing for 11 patients in dexamethasone group and 11 patients in placebo group.|||Participants|||Count of Participants
2634572|NCT01812057|Secondary|Incidence of Chronic Persistent Pain at 8 Weeks|Patients answered a questionnaire at 8 weeks to determine whether they still had persistent surgical site pain 8 weeks following surgery|8 weeks from the day of surgery|Analysis was based on available data from both arms including 26 patients. Data was missing for 13 patients in dexamethasone group and 8 patients in placebo group.|||Participants|||Count of Participants
2634573|NCT01812057|Secondary|Cumulative Opioid Consumption at 24 Hours Between MTS Groups|Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0 = no pain and 100= worst pain possible) after the 1st and 11th tap. A difference < 1 was recorded as MTS negative, and a difference > or = 1 was recorded as MTS positive.|24 hours from admission to Postanesthesia care unit (PACU)|Analysis was based on all 47 patients who completed the study.|||milligrams||Inter-Quartile Range|Median
2634574|NCT01812057|Secondary|Pain Scores Between the Groups at 48 Hours.|Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.|48 hours from PACU Admission||||units on a scale||Inter-Quartile Range|Mean
2634575|NCT01812057|Secondary|Pain Scores Between the Groups at 24 Hours.|Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.|24 hours from PACU admission||||units on a scale||Inter-Quartile Range|Median
2634576|NCT01812057|Secondary|Cumulative Opioid Consumption at 48 Hours Between the Groups|The secondary outcome was the cumulative morphine consumption at 48 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine|Admission to PACU through 48 hours||||milligrams||Inter-Quartile Range|Median
2634577|NCT01812057|Secondary|Time to Administration of First Rescue Analgesic Request Between the Groups.|Time in minutes from admission to PACU to the first request by the patient for oral oxycodone (analgesia) administration for pain|PACU admission to discharge from PACU an average of 2 hours|Analysis was based on all 47 patients who completed the study.|||minutes||Inter-Quartile Range|Median
2634578|NCT01812057|Secondary|Pain Scores Between the Groups at 2 Hours.|Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.|2 hours from admission to postanesthesia care unit (PACU)||||units on a scale||Inter-Quartile Range|Median
2634579|NCT01812057|Primary|Morphine Consumption at 24 Hours Post-op|The primary outcome will be the cumulative morphine consumption at 24 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine|24 hours from admission to Postanesthesia care unit (PACU)||||milligram||Inter-Quartile Range|Median
2634580|NCT01812044|Secondary|Peak Pain Score During First 30 Minutes|"This secondary outcome will include the peak pain score for duration of follow up period. Pain will be assessed by masked observers, using the CHEOPS scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain.~Pain is rated every 5 minutes for the first 30 minutes postoperatively."|0-30 minutes post-operative||||units on a scale||Standard Deviation|Mean
2634581|NCT01812044|Secondary|Number of Participants Who Required Anti-emetic Medication Post-operatively||Total time in post-operative recovery - up to 6 hours||||participants|||Number
2634582|NCT01812044|Secondary|Number of Participants With Post Operative Nausea and Vomiting||0-150 minutes post-operative||||participants|||Number
2634583|NCT01812044|Secondary|Average Time to Discharge||0-150 minutes post-operative||||minutes||Standard Deviation|Mean
2634584|NCT01812044|Secondary|Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire)|"This secondary outcome will determine the negative postoperative behaviors based on the PHBQ questionnaire given to the parents of the child 1 week (+/- 3 days) post-operatively.~with a score of 81 indicating no change, a score of less than 81 indicating a change for the better, and a score of over 81 indicating a change for the worse, on average, in behavior.~Lowest score 27; highest score 135"|1 week (+/- 3 days) post operatively||||units on a scale||Standard Deviation|Mean
2634585|NCT01812044|Secondary|Total Narcotic Use During Post-operative Recovery|This secondary outcome will include total narcotic use|Total time in post-operative recovery - up to 6 hours||||mcg/kg||Standard Deviation|Mean
2634633|NCT01811472|Secondary|Change From Baseline in Body Weight||Baseline, 12 and 24 weeks|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with both baseline and post-baseline values at different timepoints were included in this endpoint analysis|||kilogram (kg)||90% Confidence Interval|Least Squares Mean
2634586|NCT01812044|Secondary|Peak Pain Score|"This secondary outcome will include the peak pain score for duration of follow up period. Pain will be assessed by masked observers, using the CHEOPS scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain.~A pain score was assessed and recorded every 5 minutes by a masked observer (clinical research coordinator) for the first 30 minutes after extubation, then every 15 minutes for the next hour, then, if applicable, hourly until discharge."|0-150 minutes post-operative||||units on a scale||Standard Deviation|Mean
2634587|NCT01812044|Primary|Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale|"Pain will be assessed by a masked observer using the Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain.~Pain is rated every 5 minutes for the first 30 minutes postoperatively. Each pain score collected in the first 30 minutes was averaged to calculate a per per participant average pain score over the first 30 minutes . Then each participant's per participant average pain score was combined to calculate the reported mean for Average pain score over the first 30 post-operative minutes using the CHEOPS scale. for each group."|0-30 minutes post-operative||||units on a scale||Standard Deviation|Mean
2634588|NCT01812005|Secondary|Complete Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 weeks (6 courses)|The data was not collected and analyzed for this outcome measure||||||
2634589|NCT01812005|Secondary|Progression-free Survival|Graphically summarized using the methods of Kaplan and Meier.|Time from study entry to the time of progression and/or death, assessed up to 1 year||||months||95% Confidence Interval|Median
2634590|NCT01812005|Secondary|Overall Survival|Graphically summarized using the methods of Kaplan and Meier.|Time from study entry to the time of death due to any cause, assessed up to 1 year|data was not collected for participants in Cohort A|||months||95% Confidence Interval|Median
2634591|NCT01812005|Secondary|Complete Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|12 weeks (4 courses)|data was not collected for participants in Cohort B (Alisertib, Rituximab)|||percentage of patients||95% Confidence Interval|Number
2634592|NCT01812005|Secondary|Complete Response Rate (CR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 weeks (2 courses)|2 course endpoints only apply to Cohort B, since Cohort B only received 2 courses of the interested drug|||percentage of patients||95% Confidence Interval|Number
2634593|NCT01812005|Secondary|Overall Response Rate(ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 weeks (6 courses)||||percentage of patients|||Number
2634594|NCT01812005|Secondary|Overall Response Rate (ORR)|95% binomial confidence intervals calculated.|12 weeks (4 courses)|"Data were not collected from the single participant in the Cohort A (Alisertib, Rituximab) Arm/Group therfore the 95% Confidence Interval was incalculable due to an insufficient number of events"||||||
2634595|NCT01812005|Secondary|Overall Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 weeks (2 courses)|2 course endpoints only apply to Cohort B, since Cohort B only received 2 courses of the interested drug|||percentage of patients||95% Confidence Interval|Number
2634596|NCT01812005|Primary|Best Overall Response Rate (ORR) to Alisertib Alone|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 18 weeks (6 courses)||||percentage of patients||95% Confidence Interval|Number
2634597|NCT01811953|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Metformin|AUC0-tz: area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point for Metformin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2634598|NCT01811953|Primary|Maximum Measured Concentration of the Analyte in Plasma, Metformin|Cmax: maximum measured concentration of the analyte in plasma for Metformin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2634644|NCT01811355|Primary|Cramp Severity|Daily cramp severity was rated on the 100-unit visual analog scale. Scores ranged from 0 to 100, with 100 being the greatest amount of cramp severity|6 weeks|Among the 21 patients who completed the study, 1 patient did not return the outcome diary, which resulted in 20 patients available for analysis.|||units on a scale||Standard Deviation|Mean
2634599|NCT01811953|Primary|Maximum Measured Concentration of the Analyte in Plasma, Empagliflozin|Cmax: maximum measured concentration of the analyte in plasma for Empagliflozin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2634600|NCT01811953|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point, Empagliflozin|AUC0-tz: area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point for Empagliflozin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2634601|NCT01811953|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Metformin|AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Metformin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|PKS: included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2634602|NCT01811953|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity, Empagliflozin|AUC0-inf: area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity for Empagliflozin|1 hour (h) before first drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 3h 30 min, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic set (PKS): included all subjects of the TS who provided at least one observation for at least one primary PK endpoint and who did not have a protocol violation relevant to the evaluation of Pharmacokinetics.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2634603|NCT01811940|Secondary|Any Three Consecutive Weeks of Abstinence During Study|The proportion of participants in each study arm achieving sustained cocaine abstinence for three consecutive weeks at any time during the 14 week trial. This will be measured by self reported cocaine use on the daily Time line Follow Back (TLFB)and corroborated by the urine toxicology samples collected 3 times per week.|14 weeks of study or length of study participation||||Participants|||Count of Participants
2634604|NCT01811940|Primary|Three Weeks of Cocaine Abstinence at End of Study|The number of participants in each study arm achieving sustained cocaine abstinence for three consecutive weeks at the end of the study. This will be measured by self reported cocaine use on the daily Time line Follow Back (TLFB) and corroborated by the urine toxicology samples collected 3 times per week.|assessed during 14 weeks of trial, presented for last 3 weeks||||Participants|||Count of Participants
2634605|NCT01811732|Secondary|Investigator Assessment at the Late Follow-up Visit|"A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.~A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing)."|Study Day 21 to 28|ITT Population|||Participants|||Count of Participants
2634606|NCT01811732|Secondary|Investigator Assessment at the Follow-up Visit (EMA Primary Endpoint)|"A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.~A sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing)."|Study Day 14 +/- 1 day|ITT Population|||Participants|||Count of Participants
2634607|NCT01811732|Primary|Objective Response at 48 to 72 Hours (FDA Primary Endpoint)|A patient was considered a responder if s/he had a ≥20% reduction in size of the area of erythema associated with the baseline ABSSSI, as determined by digital planimetry of the leading edge and had none of the reasons for clinical failure; a patient was considered a non-responder (failure) if s/he had <20% reduction in size of the area of erythema associated with the baseline ABSSSI as determined by digital planimetry of the leading edge, or had major intervention such as another antibiotic or surgical intervention or died within 74 hours after initiation of study drug.|48 to 72 hours after starting treatment|ITT Population|||Participants|||Count of Participants
2634608|NCT01811706|Secondary|Biomechanical Assessment of Gait (BAG)-Stride Length|Biomechanical Assessment of Gait is a sensitive, quantitative movement analysis system. Stride length was analyzed. Baseline values are recorded twice. One was at the beginning of the intervention. The second was 2 weeks after washout period and before the second intervention.|Baseline and 4 weeks after Dalfampridine or placebo||||cm||Standard Deviation|Mean
2634645|NCT01811355|Primary|Daily Muscle Cramps|The average of the daily recording of number of muscle cramps that occurred in the last 24 hours- over a 6 week period.|6 weeks|Among the 21 patients who completed the study, 1 patient did not return the outcome diary, which resulted in 20 patients available for analysis.|||Cramps per 24 hours||Standard Deviation|Mean
2634609|NCT01811706|Secondary|Change in Scale of Assessment and Rating of Ataxia (SARA)|Scale for the assessment and rating of ataxia (SARA) is a clinical scale that is based on a semiquantitative assessment of cerebellar ataxia on an impairment level. SARA has 8 items that are related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test. SARA score ranges from 0 to 40, with higher scores indicating more severe disease.|Baseline and 4 weeks after Dalfampridine or placebo||||point||Standard Deviation|Mean
2634610|NCT01811706|Primary|Change in Timed 25 Feet Walking Test (T25FW)|The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time, in seconds, is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. Baseline values are recorded twice. One was at the beginning of the intervention. The second was 2 weeks after washout period and before the second intervention.|Baseline and 4 weeks after Dalfampridine or placebo|Patient with spinocerebellar ataxia (SCA) 1, 2, 3, or 6|||second||Standard Deviation|Mean
2634611|NCT01811680|Primary|10 Meter Walk Test|Assess time taken to walk 10meters to estimate walking speed(m/s) (Assessed at weeks 0,2,4,8)|8 weeks||||m/s||Standard Deviation|Mean
2634612|NCT01811680|Primary|6 Minute Walk Test (Metres)|6 minute walk test - assess distance walked within 6 minutes as a sub maximal test of endurance (Assessed at weeks 0,2,4 and 8)|8 weeks|chronic stroke|||metres||Standard Deviation|Mean
2634613|NCT01811654|Secondary|PFPS Severity Scale (PSS) Score|"Encompasses 10 statements regarding PFPS pain. Severity scale consists of 10 statements, rated from 0 indicating no pain and a 10 indicating pain as bad as it could be."|3 month follow-up||||score on a scale||Standard Deviation|Mean
2634614|NCT01811654|Primary|Change in Visual Analog Scale (VAS) Score|A 100mm visual analog scale (VAS) for activity related pain assessment will serve as the primary outcome measure. The 2-sample t-test comparing the two treatment groups' mean change from baseline issued. No pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). The 2 sample t-test approximates the test of the null hypothesis that there is a difference in mean change from baseline in the VAS for activity-related pain between the HA group and control group. Higher scores indicate higher level of pain.|At baseline and 3 month follow-up|"Both  Overall Number of Participants Analyzed and Participant Flow are now consistent"|||millimeters||Standard Deviation|Mean
2634615|NCT01811563|Other Pre-specified|Timed Get up and go|The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.|Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement|The 6 week time point was not used in the final analysis based on the clinical decision that 6 weeks was too early in recovery to provide accurate information for clinical decision making. Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).|||Seconds||Standard Deviation|Mean
2634616|NCT01811563|Other Pre-specified|Sit to Stand Time|The sit to stand test requires patients to stand up and sit down as many times as possible in 10 seconds from a standard arm chair.|Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement|The 6 week time point was not used in the final analysis based on the clinical decision that 6 weeks was too early in recovery to provide accurate information for clinical decision making. Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).|||Number of times||Standard Deviation|Mean
2634617|NCT01811563|Other Pre-specified|Knee Society Score (KSS)|The KSS is a patient reported measure of knee function that is specific to patients who are scheduled to receive or have previously had a total knee replacement. This outcome measures both patient reported pain and function changes from prior to surgery through recovery. The score range is from 0 to 100. The highest score of 100 points will be obtained by a well-aligned knee with no pain, 125 degrees of motion, and negligible anteroposterior and mediolateral instability.|Baseline (Pre-Operative), 6 weeks and 52 weeks following total knee replacement|Only 20 subjects in each arm completed the assessment at 1 year post-op.|||units on a scale||Standard Deviation|Mean
2634618|NCT01811563|Other Pre-specified|Change in Forgotten Joint Score (FJS) From 6 Weeks to 52 Weeks Following Total Knee Replacement.|"The FJS is a patient reported measure of how bothersome the total joint replacement is for them, how much it affects daily activity and how much they are aware of the implant. The FJS is a 12-question survey regarding functional outcome, pain, stability, daily living, activity and sport. Scoring is from 0 to 4 with 0 as the best outcome; a low score means high satisfaction. Not all questions must be answered to score, all responses are summed and the total is divided by number of completed items multiplied by 25, with the final result subtracted from 100. The score range is from 0 to 100 with the highest score of 100 indicating the best outcome (the joint is completely forgotten) and 0 indicating the worst outcome."|6 weeks and 52 weeks following total knee replacement|Participants who completed the Forgotten Joint Score (FJS) at week 6 and week 52. Not all subjects completed the FJS.|||units on a scale||Standard Deviation|Mean
2634619|NCT01811563|Other Pre-specified|Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Total From Baseline to 52 Weeks Following Total Knee Replacement.|The KOOS is a standardized and validated patient outcome score that assesses functional limitation in patient with knee problems. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|Baseline (Pre-Operative) and 52 weeks following total knee replacement|Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).|||units on a scale||Standard Deviation|Mean
2634620|NCT01811563|Other Pre-specified|University of California, Los Angeles (UCLA) Activity Score at 6 Weeks Following Total Knee Replacement.|"The UCLA activity score is a validated patient reported outcome of overall physical activity. Results on a scale of 1 to 10, 1 is Wholly Inactive, dependent on others, and can not leave residence and 10 is Regularly participates in impact sports."|6 weeks following total knee replacement|Only subjects who were able to complete the UCLA at six weeks were included in the analysis.|||units on a scale||Standard Deviation|Mean
2665182|NCT01536093|Secondary|Urinary Secretary IgA Concentration at 1 Week of Age||1 week of age||||ng per g creatinine||Standard Deviation|Mean
2634621|NCT01811563|Other Pre-specified|Change in University of California, Los Angeles (UCLA) Activity Score From Baseline to 52 Weeks Following Total Knee Replacement.|"The UCLA activity score is a validated patient reported outcome of overall physical activity. Results on a scale of 1 to 10, 1 is Wholly Inactive, dependent on others, and can not leave residence and 10 is Regularly participates in impact sports."|Baseline and 52 weeks following total knee replacement|Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).|||units on a scale||Standard Deviation|Mean
2634622|NCT01811563|Secondary|Walking Speed at 6 Weeks Following Total Knee Replacement.|Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.|6 weeks following total knee replacement||||miles per hour||Standard Deviation|Mean
2634623|NCT01811563|Secondary|Change in Walking Speed From Baseline to 52 Weeks Following Total Knee Replacement.|Each subject will complete three walking trials at a self-selected comfortable walking speed along a 5 meter walkway in order to record walking speed at each time point.|Baseline and 52 weeks following total knee replacement||||miles per hour||Standard Deviation|Mean
2634624|NCT01811563|Primary|Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 52 Weeks Following Total Knee Replacement|The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.|Baseline (Pre-Operative) to 52 weeks following total knee replacement|Subjects used in the final analysis were those subjects who completed the assessment at pre-op and 1 year post-op (20 subjects per arm).|||% of limb length||Standard Deviation|Mean
2634625|NCT01811563|Primary|Change in Lower Quarter Y-Balance Test (YBT-LQ) (Dynamic Balance) From Baseline to 6 Weeks Following Total Knee Replacement|The lower quarter y-balance test (YBT-LQ) is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform. The composite score is calculated as the sum of the three reach directions divided by 3 time the limb length and will be reported as a percentage of limb length.|Baseline (Pre-Operative) to 6 weeks following total knee replacement|Only subjects that were able to complete all of the YBT assessments at 6 weeks post total knee replacement were included in the analyses.|||% of limb length||Standard Deviation|Mean
2634626|NCT01811485|Secondary|Number of Patients With Adverse Events (Including Hypoglycemia), Serious Adverse Events and Death|The occurrence of adverse events were sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, sign (including an abnormal laboratory finding), or medical conditions. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.|14 weeks|Safety set (SAF): consists of all patients who received at least one dose of study medication.|||Patients|||Number
2634627|NCT01811485|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 14 Weeks|FPG was performed on a blood sample obtained and analyzed at a central laboratory.|Baseline to 14 weeks|FAS consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.|||mg/dL||Standard Error|Least Squares Mean
2634628|NCT01811485|Secondary|Percentage of Patients Meeting Responder Rates in HbA1c|"Responder rate was analyzed in categories: 1. Endpoint HbA1c ≤ 6.5% 2. Endpoint HbA1c < 7% 3. Endpoint HbA1c < 7% in patients with baseline HbA1c ≤ 8% 4. Endpoint HbA1c < 6.9% 5. HbA1c reduction from baseline at endpoint ≥ 1% 6. HbA1c reduction from baseline at endpoint ≥ 0.5%.~Categories 1, 2, and 4 - 'n' includes only patients with baseline HbA1c > 6.5%, ≥ 7%, ≥ 6.9% and endpoint HbA1c measurement. Category 3, 'n' includes only patients with 7% ≤ baseline HbA1c ≤ 8% and endpoint HbA1c. Category 5 and 6, 'n' indicates number of patients with both baseline and endpoint HbA1c measurements."|Baseline, 14 weeks|The full analysis set (FAS) consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.|||Percentage of patients|||Number
2634629|NCT01811485|Secondary|Change From Baseline in HbA1c at 14 Weeks Within LMF237 Treatment Groups|HbA1c will be performed on a blood sample obtained and measured by HPLC. HPCL was performed at a central laboratory.|Baseline to 14 weeks|Full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
2634630|NCT01811485|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 14 Weeks Between Treatment Groups|HbA1c was performed on a blood sample obtained and measured by High performance liquid chromatography (HPLC). HPCL was performed at a central laboratory.|Baseline to 14 weeks|Full analysis set consisted of all randomized patients who received at least one dose of study medication and had at least one post-randomization efficacy parameter measurement.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
2634631|NCT01811472|Secondary|Number of Patients With Adverse Events, Serious Adverse Events (SAEs) and Death as Assessment of Safety and Tolerability||24 weeks|Safety set (SAF) - All patients who received at least one dose of study drug and had at least 1 post-baseline safety assessment.|||Patients|||Number
2634632|NCT01811472|Secondary|Change From Baseline in Waist Circumference||Baseline, 12 and 24 weeks|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with both baseline and post-baseline values at different timepoints were included in this endpoint analysis|||centimeter (cm)||90% Confidence Interval|Least Squares Mean
2634646|NCT01811316|Other Pre-specified|Change From Baseline in Inflammatory Markers in Gingival Crevicular|Gingival Crevicular Fluid (GCF) samples will be analyzed for inflammatory cytokines/chemokines and matrix metalloproteases using multiplexing ELISA.|15 days, 4, 12 and 24 weeks|||||||
2634634|NCT01811472|Secondary|Post-prandial Peak Triglycerides Over 0 - 8 Hours|"Post-prandial peak triglycerides is reported as maximum triglyceride value over 0-8 hours.~Adjusted geometric means which is reported are calculated by back-transforming the adjusted means from the model. Baseline is defined as the value collected at Week 0 (randomization)."|Baseline, 6 and 24 weeks|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing values at different timepoints were included in this endpoint analysis|||mg/dL||90% Confidence Interval|Geometric Mean
2634635|NCT01811472|Secondary|Percent Change From Baseline in Fasting Triglycerides|"Blood samples were collected for a fasting triglycerides (TG) after a 10-hour (overnight) fast.~Adjusted geometric means which is reported are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline. Baseline is defined as the value collected at Week 0 (randomization)."|Baseline, 6, 12 and 24 weeks|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing values at different timepoints were included in this endpoint analysis|||percent change||90% Confidence Interval|Geometric Mean
2634636|NCT01811472|Secondary|Percentage of Patients With Normalized Liver Enzymes|Normalized liver enzymes defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 40 U/L. Normal/High categories at baseline are defined by criteria of normal. Better is defined as high' at baseline and 'normal' post-dose; Same is defined as 'normal' at baseline and 'normal' post-dose or 'high' at baseline and 'high' post-dose; Worse is defined as 'normal' at baseline and 'high' post-dose.|Baseline, week 6, week 12 and week 24|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at different timepoints were included in this endpoint analysis.|||Percentage of patients|||Number
2634637|NCT01811472|Secondary|Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 24|"Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).~Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate."|From Baseline to week 24|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at week 24 were included in this endpoint analysis.|||U/L||90% Confidence Interval|Least Squares Mean
2634638|NCT01811472|Secondary|Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 12|"Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).~Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate."|From Baseline to week 12|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at week 12 were included in this endpoint analysis.|||U/L||90% Confidence Interval|Least Squares Mean
2634639|NCT01811472|Secondary|Change From Baseline Values for Alanine Aminotransferase (ALT) , Aspartate Aminotransferase (AST) and Gamma-glutamyl Transpeptidase (GGT) to Week 6|"Change from baseline ALT, AST and GGT values collected post-dose was analyzed using Mixed Model of Repeated Measurements (MMRM). Baseline is defined as the value collected at Week 0 (randomization).~Treatment group and visit were fitted as factors and baseline was fitted as a continuous covariate."|From Baseline to week 6|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing liver enzyme values at different timepoint were included in this endpoint analysis.|||U/L||90% Confidence Interval|Least Squares Mean
2634640|NCT01811472|Secondary|Percentage of Responders at Week 24|"The response criteria are defined as:~a. A reduction of ≥ 30% from baseline in liver fat b. A reduction of ≥ 50% from baseline in liver fat c. Liver fat content < 10% d. Liver fat content < 5.6%. Percentage is calculated as (m/n)*100 where m: number of patients who are responders. n: number of patients with non-missing percent liver fat at that visit."|From baseline to week 24|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing percent liver fat at week 24 were included in this endpoint analysis.|||Percentage of responders|||Number
2634641|NCT01811472|Secondary|Percentage of Responders at Week 12|"The response criteria are defined as:~a. A reduction of ≥ 30% from baseline in liver fat b. A reduction of ≥ 50% from baseline in liver fat c. Liver fat content < 10% d. Liver fat content < 5.6%. Percentage is calculated as (m/n)*100 where m: number of patients who are responders. n: number of patients with non-missing percent liver fat at that visit."|At week 12|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with non-missing percent liver fat at week 12 were included in this endpoint analysis.|||Percentage of responders|||Number
2634642|NCT01811472|Secondary|Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 12|Patients were to undergo MRI three times during the course of the study to assess liver fat. Baseline is defined as the value collected at Week -2 MRI assessment (approximately between Day -7 to -14).|From baseline to week 12|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with baseline and post-baseline value at week 12 are included in this analysis.|||Percentage of liver fat||90% Confidence Interval|Least Squares Mean
2634643|NCT01811472|Primary|Change From Baseline in Percentage of Fat in the Liver as Assessed Using MRI at Week 24|Patients were to undergo MRI three times during the course of the study to assess liver fat. Baseline is defined as the value collected at Week -2 MRI assessment (approximately between Day -7 to -14).|From baseline to week 24|Full analysis set included all patients to whom study treatment was assigned excluding patients who were miss-randomized and did not take investigational drug. Patients with baseline and post-baseline value at week 24 are included in this analysis.|||Percentage of liver fat||95% Confidence Interval|Least Squares Mean
2665183|NCT01536093|Primary|Urinary Secretary IgA Concentration at 2 Weeks of Age||2 weeks of age||||ng per g creatinine||Standard Deviation|Mean
2634648|NCT01811316|Secondary|Change From Baseline in Plaque Index (PI)|"Plaque Index of Turesky Modification of Quigley-Hein (Turesky, Gilmore et al. 1970) (PI) was scored on all natural teeth (except third molars) after disclosing with erythrosine solution. Scores Criteria:~0 No plaque~Separate flecks of plaque at the cervical margin of the tooth~A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth~A band of plaque wider than one mm but covering less than one-third of the crown of the tooth~Plaque covering at least one-third but less than two-thirds of the crown of the tooth~Plaque covering two-thirds or more of the crown of the tooth"|4, 12 and 24 weeks|One subject was lost to follow up between 4 and 12 weeks.|||units on a scale||Standard Deviation|Mean
2634649|NCT01811316|Primary|Change From Baseline in Bleeding on Probing (BOP)|Bleeding on probing was assessed 30 seconds after probing. A dichotomous scoring system was used at six sites per tooth using one (1) and zero (0) for presence or absence, respectively. BOP (%) is a percentage of sites BOP.|4, 12 and 24 weeks|One subject was lost to follow up between 4 and 12 weeks.|||percentage of sites BOP||Standard Deviation|Mean
2634650|NCT01811316|Primary|Change From Baseline in Modified Gingival Index (MGI)|"Modified Gingival Index (MGI) (Lobene, Weatherford et al. 1986) was measured on six gingival areas of all scorable teeth, using a scale of 0-4 as follows: Scores Criteria 0 Normal (absence of inflammation)~Mild inflammation (slight change of color, little change in texture) of any portion of, but not the entire marginal or papillary gingival unit~Mild inflammation of the entire gingival unit~Moderate inflammation (moderate glazing, redness, edema and/or hypertrophy) of the marginal or papillary gingival unit~Severe inflammation (marked redness and edema/hyper-trophy, spontaneous bleeding or ulceration) of the marginal or papillary gingival unit.~Whole mouth MGI scores were calculated by summing all scores and dividing by the number of examined scorable sites."|4, 12 and 24 weeks|One subject was lost to follow up between 4 and 12 weeks.|||units on a scale||Standard Deviation|Mean
2634651|NCT01811303|Secondary|Maximum Blood Glucose Concentration (C Max) Over the Baseline|"Determine the glucose C max of Sucrose with D-fagomine over the baseline.~The blood glucose maximum concentration (C-Max) expressed in mmol/L of the average response for a 50g sucrose, over the baseline.~Calculation of the outcome is= (Measure glucose C-Max - Measure glucose baseline)"|Usually in the range of 30-45 minutes||||mmol/L||Standard Error|Mean
2634652|NCT01811303|Primary|Postprandial Glycaemic Response Index|On each intervention, the volunteer measured a baseline fasting blood sugar measurement for that day and repeated this approximately 5 minutes later so that two fasting measurements were obtained under the supervision of staff. All of the subsequent measurements were assessed against the average of the two baseline readings. Each subject was then presented with a test product and they were instructed to consume the whole amount within a fifteen-minute period. Each volunteer then took a blood sugar readings at 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of the test product. Measurements were taken using the Ascensia Contour, Blood Glucose Monitoring Systems (Bayer), which analysed the blood sample and provided a blood glucose reading in mmol/l. The AUC is calculated using the trapezoid rule and the final outcome is the incremental area under the curve for the arm expressed as a percent of the average response for the control by the same subject.|120 minutes|The number of participants >10, the repetitions >= 2 and also other variables was determined based on F. Brouns et al., Glycaemic index methodology,Nutrition Research Reviews (2005), 18, 145–171. Also was considered the advice and previous GI studies from RSSL based on master protocol GIMST09.|||percentage of AUC fagomine/AUC control||95% Confidence Interval|Mean
2634653|NCT01811238|Secondary|Patient Global Impression of Change(PGIC)|Number of participants with categorical change in overall satisfaction. PGIC: a participant-rated instrument assessing change in participant's overall satisfaction from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).|Baseline, 8week|IIT set, Missing values were imputed by LOCF.|||participants|||Number
2634654|NCT01811238|Secondary|Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)|The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' (score = 100) and 'Worst imaginable health state' (score = 0). Higher points were positive results and positive points of difference gap means improvement results.|Baseline, 8 weeks|ITT set, Missing values were imputed by LOCF. Difference (Visti 4(8w)-Baseline)|||scores on a scale||Standard Deviation|Mean
2634655|NCT01811238|Secondary|Change of Pain Intensity in Patient With Spinal Disorder at Week 4 of Treatment With the Study Drug From Baseline|"NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain).~Change = mean score at Week 4/ET minus mean score at Baseline."|Baseline, 4 week|IIT set.|||units on a scale||Standard Deviation|Mean
2634656|NCT01811238|Secondary|Clinical Global Impression of Change(CGIC)|"The number of patients who choose the best opinion of overall satisfaction among Clinical Global Impression of Change Scale(CGIC) among 7 point scale. Missing data was imputed by LOCF.~Very much improved much improved minimally improved no change minimally worse much worse very much worse"|Baseline, 8 week|ITT Population. Below results : Visit 4(8week)(LOCF): n(%)|||participants|||Number
2634657|NCT01811238|Secondary|The Change in Quality of Life (EQ-5D) at Week 8 of Treatment With the Study Drug From Baseline|"EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)).~Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2)~*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)~EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by 1 means that the healthy condition and high quality of life."|Baseline, 8 week|ITT set included all subjects who participated in the study and had at least one dose of the study drug and had at least one primary efficacy endpoint data available.Missing values were imputed by LOCF.|||scores on a scale||Standard Deviation|Mean
2634722|NCT01810289|Primary|Cumulative Incidence of ART Initiation 14 Days After Clinical Eligibility in Treatment Eligible HIV-infected Patients|Patients may be ART eligible at the start of the study or become ART eligible for the first time in the 3 year time frame.|14 days|Persons who did have the opportunity for 14 days of follow up were excluded from these analyses.|||participants|||Number
2634658|NCT01811238|Primary|Change From Baseline in Pain Intensity of Patient With Spinal Disorder as Measured by NRS.|"NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain).~Change = mean score at Week 8/ET minus mean score at Baseline."|Baseline, 8 week|"The 209 is IIT set population. ITT set included all subjects who participated in the study and had at least one dose of the study drug and had at least one primary efficacy endpoint data available.~Missing values were imputed by LOCF."|||scores on a scale||Standard Deviation|Mean
2634659|NCT01811212|Secondary|Response of Cabozantinib-s-malate in Bone Metastasis (Bone Metastasis-specific Progression Free Survival) as Evaluated by Functional Imaging||Up to 2 months|Data not collected to be analyzed at this time||||||
2634660|NCT01811212|Secondary|Progression-free Survival|The Kaplan-Meier method will be used.|Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year||||months||95% Confidence Interval|Median
2634661|NCT01811212|Secondary|Percent Change in Serum Tumor Marker Thyroglobulin Levels|Side-by-side boxplots will be used to assess possible differences in this change between responders and non-responders, and scatterplots can assess the influence of baseline thyroglobulin levels on these measures of change.|Baseline to 6 months|Data not collected to be analyzed at this time||||||
2634662|NCT01811212|Secondary|Overall Survival|The Kaplan-Meier method will be used.|Time from start of treatment to time of death, assessed up to 1 year|the end of the range was not reached|||months||95% Confidence Interval|Median
2634663|NCT01811212|Secondary|Incidence of Severe (Grade 3+) Adverse Events, Graded According to the National Cancer Institute CTCAE v4.0|The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. Tolerability of the regimens will be assessed through assessing the number of patients who required dose modifications and/or dose delays. In addition, the proportion of patients who go off treatment due to adverse reactions or even those who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial will be captured.|Up to 1 year||||Participants|||Count of Participants
2634664|NCT01811212|Secondary|Genotype of Biomarkers Potentially Predictive of Response|These baseline levels will be quantitatively summarized and graphically explored, in particular in terms of how they relate to clinical outcomes of interest. Analyses exploring differences in these angiogenic and correlative markers in relation to clinical outcomes will be largely hypothesis-generating. With limited numbers of patients patterns of difference will primarily be looked for using graphical analyses; these can include plots of these marker levels in relation to clinical outcomes to identify potential patterns of interest.|Baseline|Data not collected to be analyzed at this time||||||
2634665|NCT01811212|Secondary|Expression Levels of Predictive Biomarkers of Response by Immunohistochemistry in Archived Tumor Tissue|These baseline levels will be quantitatively summarized and graphically explored, in particular in terms of how they relate to clinical outcomes of interest. Analyses exploring differences in these angiogenic and correlative markers in relation to clinical outcomes will be largely hypothesis-generating. With limited numbers of patients patterns of difference will primarily be looked for using graphical analyses; these can include plots of these marker levels in relation to clinical outcomes to identify potential patterns of interest.|Baseline|Data has not been collected and analyzed at this time||||||
2634666|NCT01811212|Secondary|Duration of Objective Response as Assessed by the RECIST v1.1|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From date of documentation of response to the date of progression or death, assessed up to 1 year||||months||95% Confidence Interval|Median
2634667|NCT01811212|Secondary|Bone Turnover, as Measured by Serum and Urinary Markers of Bone Turnover||Up to 2 months|Data not collected to be analyzed at this time||||||
2634668|NCT01811212|Primary|Objective Response Rate, Defined as the Proportion of Patients Who Have Had a PR or CR as Assessed by the RECIST Version (v)1.1|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 6 months||||Participants|||Count of Participants
2634669|NCT01811186|Secondary|Assessment of Subject's Overall Satisfaction After 6 Weeks Treatment With the Study Drug|At each visit, the subject assessed the overall satisfaction for efficacy by using the 7 point scale of Patient Global Impression of Change Scale(PGIC).|6weeks|ITT analysis set: 171. Last visit(Visit 5) data was handled as LOCF. However, Missing Number as visit 3 for assessment of Investigator’s overall satisfaction after 6 weeks treatment with the study drug was Group A = 50, Group B=37.|||participants|||Number
2634670|NCT01811186|Secondary|Assessment of Investigator's Overall Satisfaction After 6 Weeks Treatment With the Study Drug|Investigator's overall satisfaction after treatment (6 weeks) (Clinical Global Impression of Change Scale(CGIC) 7 point scale) by treatment arm were summarized and presented as frequency and proportion, and the inter-group difference were compared by using a Chi-square test or Fisher's exact test.|6 weeks|ITT analysis set: 171. Last visit(Visit 5) data was handled as LOCF. However, Missing Number as visit 3 for assessment of Investigator’s overall satisfaction after 6 weeks treatment with the study drug was Group A = 50, Group B=37.|||participants|||Number
2634671|NCT01811186|Secondary|Change of Quality of Life (EQ-5D) Score After 6 Weeks Treatment With the Study Drug|"EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)).~Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2)~*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)~EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by 1 means that the healthy condition and high quality of life."|6 weeks|ITT analysis set.|||units on a scale||Standard Deviation|Mean
2634723|NCT01810263|Other Pre-specified|Subjective Global Assessment||6 months|||||||
2634724|NCT01810263|Other Pre-specified|Triceps Skin Fold Thickness||6 months|||||||
2634673|NCT01811186|Secondary|The Drop-out Rate Due to an Adverse Event After 1 Week Treatment With the Study Drug.|The drop-out rate due to an adverse event after treatment (1 week) by treatment arm were summarized and presented as frequency and percentage, and the inter-group difference were compared by using a Chi-square test or Fisher's exact test.|1 week|Intent to treat analysis set: 258(Last observation Carried Forward)|||percentage of participants|||Number
2634674|NCT01811186|Primary|Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment|To assess the drop-out rate caused by adverse event* after 6 weeks treatment|6 weeks|Intent to treat analysis set: 258 patients (Last Observation Carried Forward)|||percentage of participants|||Number
2634675|NCT01811147|Secondary|YMRS: Young Mania Rating Scale|Young Mania Rating Scale: Scores can range from 0 to 60: In Remission/No Mania (0-8); Mild (9-12); Moderate (13-18); Severe (19-25); Very Severe (>25)|24 months||||score on a scale||Standard Deviation|Mean
2634676|NCT01811147|Primary|HAM-D 17 Item: Hamilton Depression Rating Scale|"Hamilton depression rating scale (17-item HAM-D):~Scores can range from 0 to 52: No depression (0-7); Mild depression (8-16); Moderate depression (17-23); and Severe depression (≥24)."|24 months||||score on a scale||Standard Deviation|Mean
2634677|NCT01810952|Post-Hoc|Percent of Glucose Determinations >180 mg/dL||1-5 days||||Percent of glucose values|||Number
2634678|NCT01810952|Secondary|Glucose Values <70 mg/dL.|# participants with glucose values <70 mg/dL|1-5 days||||participants|||Number
2634679|NCT01810952|Secondary|Daily Insulin Dose/Kg Body Weight|Total daily dose of insulin required based on weight and glucocorticoid dosage to achieve average daily finger stick glucose (FSG) levels of 90-140 mg/dL|1-5 days||||units of insulin/Kg body weight||Standard Deviation|Mean
2634680|NCT01810952|Secondary|Percent of Participants With Average Glucose >70 and <180 mg/dL|Percent of Participants with Average Daily Glucose >70 and <180 mg/dL|Last Full Day of Protocol for Participant (up to Day 5)||||percentage of participants|||Number
2634681|NCT01810952|Primary|Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol.|"Most patients had 4 and all patients had at least 2 readings each day. Average daily glucose values were determined for each participant, then averaged for each Arm."|1-5 days|We used t-tests to compare values between the protocols on each day..|||mg/dL||Standard Deviation|Mean
2634682|NCT01810939|Primary|Change in Serum Potassium From Part B Baseline|"Change in Serum Potassium from Part B Baseline to either:~Part B Week 4 visit, if the participant's serum potassium remained ≥ 3.8 mEq/L and < 5.5 mEq/L up to the Part B Week 4 visit or the earliest Part B visit at which the participant's serum potassium was < 3.8 mEq/L or ≥ 5.5 mEq/L."|Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L||||mEq/L||Inter-Quartile Range|Median
2634683|NCT01810939|Primary|Change in Serum Potassium From Part A Baseline to Part A Week 4|The primary analysis endpoint is the change from Baseline at Week 4. The estimate of the change at Week 4 is from a repeated measures model, which includes data from Weeks 1, 2, 3 and 4. The analysis includes all intent to treat participants who had a serum potassium result at baseline and at least one weekly post-baseline visit (i.e. Part A Week 1 or later) and excludes six participants who had no result collected after Day 3).|Part A Baseline to Part A Week 4||||mEq/L||Standard Error|Least Squares Mean
2634684|NCT01810939|Secondary|Proportion of Participants With Serum Potassium ≥ 5.1 mEq/L in Part B||Part B Baseline to Part B Week 8|Percentages were estimated not as simple ratios, but by using a stratified method, in order to account for differences between the patiromer and placebo groups in terms of whether participants had type 2 diabetes mellitus and whether they entered the study with serum potassium < 5.8 mEq/L or serum potassium ≥ 5.8 mEq/L.|||percentage of participants|||Number
2634685|NCT01810939|Secondary|Proportion of Participants With Serum Potassium That Was ≥ 5.5 mEq/L in Part B||Part B Baseline to Part B Week 8||||percentage of participants|||Number
2634686|NCT01810939|Secondary|Proportion of Participants With Serum Potassium Levels in the Target Range of 3.8 to < 5.1 mEq/L at Part A Week 4||Week 4|Proportion of participants with serum potassium level in the target range at Part A Week 4|||percentage of participants||95% Confidence Interval|Number
2634687|NCT01810783|Primary|Safety and Tolerability|Number of treatment-emergent adverse events (TEAEs)|Up to 52 weeks and a safety follow-up by telephone contact or clinic visit after 30 days after the last dose of investigational medicinal product (IMP)|210 patients were enrolled, only 209 patients were treated with brexpiprazole.TAES is based on these 209 patients|||TEAEs|||Number
2634688|NCT01810692|Secondary|Overall Satisfaction Question|The overall satisfaction ranges from 1=very dissatisfied to 7=very satisfied.|day 1|Patients from FAS|||units on a scale||Standard Deviation|Mean
2634689|NCT01810692|Secondary|Total Convenience PASAPQ Score|All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the convenience domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.|day 1|Patients from FAS.|||units on a scale||Standard Deviation|Mean
2634690|NCT01810692|Secondary|Total Performance PASAPQ Score.|All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the performance domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.|day 1|Patients from FAS.|||units on a scale||Standard Deviation|Mean
2634691|NCT01810692|Primary|Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ)|Patient satisfaction with regard to the total score of the handling of the inhaled devices performed by means of a PASAPQ. All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the total score, the sum of the 13 items of the two domains (performance and convenience) was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction.|day 1|Patients from the Full Analysis Set (FAS) which includes all patients from TS who provide evaluable data for the total score of the PASAPQ.|||units on a scale||Standard Deviation|Mean
2634721|NCT01810289|Secondary|Incidence of Mortality in Treatment-eligible, HIV-infected Patients.|We ascertained mortality in the subgroup of those selected for HIV RNA assessment. Vital status is not reliably reported in program data. Assessment was 1 year after ART eligibility.|1 years|Mortality information is not systematically measured in the program data. We assessed this outcome in the subgroup selected for HIV RNA.|||percentage of reported deaths|||Number
2634692|NCT01810666|Secondary|Difference of Intra-individual Change of Joint Function During Each Period Assessed by the Hemophilia Joint Health Score Between On-demand and Prophylaxis Period|Hemophilia Joint Health Score(HJHS) ranges from 0 to 124. Higher values in the HJHS represent worse situation for the subject. 2-sided Hodges Lehmann estimates for median 95% CI HJHS values difference of changes ITT analysis set.|From baseline to Week 12 (on-demand treatment) and Week 24 (prophylactic treatment)||||Scores on scale||95% Confidence Interval|Median
2634693|NCT01810666|Secondary|Difference of Annualized Number of Joint Bleeds Between On-demand and Prophylaxis Period|Annualized joint bleedings period 1 minus period 2 ITT analysis set.|Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment)||||Bleeds||95% Confidence Interval|Median
2634694|NCT01810666|Primary|Difference of Annualized Number of All Bleeds Between On-demand and Prophylaxis Period|Annualized bleedings period 1 minus period 2 ITT analysis set.|Week 1-12 (on-demand treatment) and 13-24 (prophylactic treatment)||||Bleeds||95% Confidence Interval|Median
2634695|NCT01810432|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib||Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All participants with evaluable tmax data.|||hours (h)||Full Range|Median
2634696|NCT01810432|Primary|PK: Area Under Concentration Versus Time Curve Over the 24-hour Dosing Interval (AUCτ) of Evacetrapib||Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All participants with evaluable AUCτ data.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2634697|NCT01810432|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib||Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All participants with evaluable Cmax data.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2634698|NCT01810380|Secondary|PSP Domain D: Disturbing and Aggressive Behaviours at Week 6|"PSP domain D: disturbing and aggressive behaviours were categorised as aggressive (corresponding to mild, manifest, marked, severe, or very severe) or nonaggressive (corresponding to absent)"|Week 6|FAS. As this was based on observed cases, only patients who have PSP assessment at Week 6 were included in this analysis; the number of participants analysed is therefore smaller than the defined FAS and also smaller than other PSP analyses where last assessment carried forward was used.|||percentage of aggressive patients|||Number
2634699|NCT01810380|Secondary|PSP Functional Response Rate at Week 6|The PSP functional response rate was defined as ≥10 point improvement from Baseline on the PSP total score|Week 6|FAS (last assessment). Patients who have no post-baseline PSP values available were not included as response is defined based on change from baseline and no baseline carried forward analysis was planned; the number of participants analysed is therefore smaller than the defined FAS.|||percentage of responders|||Number
2634700|NCT01810380|Secondary|PSP Functional Remission Rate at Week 6|The PSP functional remission rate was defined as a PSP total score ≥71|Week 6|FAS (last assessment). Patients who have no post-baseline PSP values available were not included as response is defined based on change from baseline and no baseline carried forward analysis was planned; the number of participants analysed is therefore smaller than the defined FAS.|||percentage of remitters|||Number
2634701|NCT01810380|Secondary|Change From Baseline to Week 6 in PSP Total Score|The Personal and Social Performance Scale (PSP) is a clinician-rated scale designed and validated to measure a patient's current level of social functioning. The PSP scale consists of a 100-point single-item rating scale, subdivided into 10 equal intervals. Scores of 1 to 10 indicate lack of autonomy in basic functioning, whereas scores of 91 to 100 reflect excellent functioning. The total score is rated by the investigator and is based on an algorithm which takes both the ratings of the 4 primary domains of PSP, and the combination of these ratings into account. The 4 primary domains are: socially useful activities (including work and study), personal and social relationships, self-care, and disturbing and aggressive behaviours. The 4 domains are assessed on a 6-point scale, from absent to very severe. A higher score indicates a better performance.|Baseline and Week 6|FAS. PSP was collected at Baseline, Day 21 and Day 42 only, due to the windowing only patients with PSP assessments between Days 15 to 27 and after Day 35 were included in this analysis; the number of participants analysed is therefore smaller than the defined FAS and also smaller than other PSP analyses using LOCF.|||units on a scale||Standard Error|Mean
2634702|NCT01810380|Secondary|Response Rate at Week 6|The response rate was defined as a reduction of ≥30% from baseline in PANSS total score OR a CGI-I score of 1 or 2|Baseline and Week 6|FAS (last assessment)|||percentage of responders|||Number
2634703|NCT01810380|Secondary|Discontinuation Due to Lack of Efficacy During the Study|Discontinuation due to lack of efficacy was based on the primary reason for withdrawal|Baseline to Week 6|APTS|||percentage of patients|||Number
2634704|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety/Depression|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: anxiety/depression is calculated from 4 items (for example: anxiety, guilt feelings, and tension). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
2634705|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: uncontrolled hostility/excitement is calculated from 4 items (for example: excitement, hostility, and uncooperativeness).Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
2634719|NCT01810289|Secondary|HIV RNA Levels Among Treatment-eligible, HIV-infected Patients One Year Following ART Eligibility|Due to financial constraints, HIV RNA was measured in a random sample of patients to asses virologic suppression.|1 year|A total of 437 (217 in control + 220 in intervention) patients were selected for blood samples. We did two analyses, one treating missing as failure and another using inverse probability weighting to address missing outcomes. The primary reported here is missing as failure.|||percentage of participants|||Number
2634725|NCT01810263|Other Pre-specified|Body Mass Index||6 months|||||||
2634706|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thoughts|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: disorganized thoughts is calculated from 7 items (for example: conceptual disorganization, difficulty in abstract thinking and mannerisms and posturing). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
2634707|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: positive symptoms is calculated from 8 items (for example: delusions, conceptual disorganization and stereotype thinking). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
2634708|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: negative symptoms is calculated from 7 items (for example: blunted affect, emotional withdrawal and motor retardation). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
2634709|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Excited Component Score|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Excited Component score is calculated from 5 items (for example: poor impulse control, tension and hostility). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
2634710|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS General Psychopathology Subscale Score|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS General Psychopathology Subscale score is calculated from 16 items (for example: somatic concern, anxiety and guilt feelings). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
2634711|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Negative Subscale Score|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Negative Subscale score is calculated from 7 items (for example: blunted affect, emotional withdrawal and poor rapport). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
2634712|NCT01810380|Secondary|Change From Baseline to Week 6 in PANSS Positive Subscale Score|The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Positive Subscale score is calculated from 7 items (for example: delusions, conceptual disorganization and hallucinatory behaviour). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
2634713|NCT01810380|Secondary|CGI-I Score at Week 6|"The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening).~The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not."|Week 6|FAS|||units on a scale||Standard Error|Mean
2634714|NCT01810380|Secondary|Change From Baseline to Week 6 in CGI-S Score|"The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness.~The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients)."|Baseline and Week 6|FAS|||units on a scale||Standard Error|Mean
2634715|NCT01810380|Primary|Change From Baseline to Week 6 in PANSS Total Score|The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms.|Baseline and Week 6|Full-analysis set (FAS)|||units on a scale||Standard Error|Mean
2634716|NCT01810302|Secondary|Number of Participants With Cerebral Vasospasm.||Day 1 of study drug until post-hemorrhage day 10.|Number of participants were not sufficient to perform data analysis.||||||
2634717|NCT01810302|Primary|Number of Participants With Bacterial Meningitis.||Day 1 of study drug until post-hemorrhage day 10.|Number of participants were not sufficient to perform data analysis.||||||
2634718|NCT01810289|Secondary|Incidence of Vertical Transmission in All HIV-infected Women Who Are Treatment-eligible During the Study Period.||3 years|Linking children to mothers in a systematic way was unattainable in these program data. We were unable to ascertain this outcome.||||||
2634720|NCT01810289|Secondary|Retention in HIV Care Among Treatment-eligible, HIV-infected Patients.|Retention was operationalized as the proportion of appointments made within 7 days within one year after ART eligibility.|1 years|Retention was assess among all in the study|||percentage of appointments made|Appointments||Number
2634726|NCT01810263|Secondary|Chemical Laboratory Findings||6 months|||||||
2634728|NCT01810042|Secondary|Visual Acuity Changes|"Visual acuity is measured at baseline and 6 months using ETDRS chart. The changes was calculated by visual acuity at 6 months minus visual acuity at baseline.~Positive values represent improvement of visual acuity, and negative values represent worsening of visual acuity at 6 months compared to baseline."|baseline and 6 months|Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy.|||ETDRS letters||Full Range|Median
2634729|NCT01810042|Secondary|Visual Acuity in ETDRS Letters|Visual acuity was assessed using the ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning.|6 months|Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy.|||ETDRS letters||Full Range|Median
2634730|NCT01810042|Secondary|Lesion Size of CNV|Lesion size of CNV is measured in fluorescein angiography using software, and find correlation with caliber of choroidal new vessels.|6 months|Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy.|||square milimeter||Full Range|Mean
2634731|NCT01810042|Primary|Caliber of Choroidal New Vessel (CNV)|Caliber of the largest CNV is measured using a software of IVAN (developed by Wisconsin University) that measures a caliber of retinal vessels using a semi-automatic method. An indocyanine green angiography (ICGA) image showing the vascular structures of CNV was processed to invert black and white for the analysis. The image was loaded in the software, and the course of the arteriolar CNV was indicated manually. Then average thickness of the vascular segment was calculated.|6 months|Of 31 patients included in the baseline analysis, 7 patients had the thickest vessels under limitation of measurement.|||micrometer||Full Range|Mean
2634732|NCT01810016|Secondary|Number of Patients With Immune-related Tumor Response at the Last Assessment|Immune-related tumor response was evaluated using the imaging techniques considered appropriate by the Investigators at Baseline, Week 13, and at the end of the study (Week 20 ± 1 week). Tumor response was designated according to the immune-related Response Criteria (irRC) (Wolchok et al. Clin Cancer Res 2009;15:7412-20) into the following categories: immune-related complete response (irCR) requires disappearance of all lesions in two consecutive observations not less than 4 weeks apart; immune-related partial response (irPR) requires ≥ 50% decrease in tumor burden compared with baseline in two observations at least 4 weeks apart; immune-related stable disease (irSD) is assigned when neither a 50% decrease from baseline tumor burden nor a 25% increase in tumor burden from nadir can be established; immune-related progressive disease (irPD) requires a ≥ 25% increase from nadir in tumor burden at any single time point in two consecutive observations at least 4 weeks apart.|Up to 5 months|The Safety Analysis Set includes all patients who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2634733|NCT01810016|Primary|Number of Patients With Treatment-emergent Adverse Events|Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Dose-limiting toxicity (DLT) was defined as any ≥ Grade 3 hematologic or non-hematologic toxicity that was definitely, probably, or possibly related to the administration of the NY-ESO-1 vaccine or as any toxicity that was definitely, probably, or possibly related to ipilimumab and required permanent discontinuation of ipilimumab in accordance with local prescribing information. DLT assessments were based on the combination of all vaccine components, not on the components individually.|Continuously for up to 6 months|The Safety Analysis Set includes all patients who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2634734|NCT01809938|Secondary|T½|"T½ = time from baseline to the time the cross-sectional surface area (CSA) of the gastric antrum, measured using realtime ultrasound, returned to half the maximal value (CSA½max ). CSA ½ max calculated as below:~CSA½max = CSAmax - [(CSAmax - CSAbaseline)/2]"|Measurments taken every 10 minutes for 1 hour and then 30 minute intervals until 150 minutes had elapsed. Each participant spent approximately 3 hours for each arm of the trial separated by no less than 24 hours.|It was difficult to visualise under ultrasound the gastric antrum in one patient after they drank both black tea and tea with milk, so they were exlcuded from final analysis of the US data only.|||minutes||95% Confidence Interval|Geometric Mean
2634735|NCT01809938|Primary|Tmax|tmax = the time taken to reach peak paracetamol concentration. The blood samples were analysed for the level of paracetamol, from which the time taken to reach peak paracetamol concentration was subsequently calculated. Blood samples were taken at the same time points as the ultrasound measurements.|Blood samples taken every 10 minutes for 1 hour and then 30 minute intervals until 150 minutes had elapsed. Each participant spent approximately 3 hours for each arm of the trial separated by no less than 24 hours||||minutes||Standard Deviation|Mean
2634736|NCT01809899|Secondary|Heart Rate|Heart rate was measured while in the scanner as a secondary psychobiological outcome to be considered in tandem with the BOLD signals from the scanner.|Baseline|No analyses were conducted due to an error in the scanner that resulted in no usable neuroimaging or physiological data. This includes the BOLD signal as well as the heart rate data and all other data collected while in the scanner.||||||
2634737|NCT01809899|Primary|Blood Oxygen-Level Dependent (BOLD) Signal|Functional Magnetic Resonance Imaging (fMRI). We were examining differences in Blood Oxygen-Level Dependent (BOLD) signal indicating reaction to a stress-provocation paradigm between the Enhanced Consent and Consent as Usual conditions.|Baseline|No analyses were conducted due to an error in the scanner that resulted in no usable neuroimaging or physiological data. This includes the BOLD signal as well as the heart rate data and all other data collected while in the scanner.||||||
2634738|NCT01809834|Secondary|Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)|Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with conjuncitval staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week|Baseline, 12-hours, 1-week||||units on a scale|Participants|Standard Deviation|Mean
2634766|NCT01809262|Secondary|Peak Forced Vital Capacity (FVC) From 0 to 3 Hours|Peak FVC was defined as the maximum values of FVC from 0 to 3 hours.|0 to 3 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint|||L||Standard Error|Mean
2634739|NCT01809834|Secondary|Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)|Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with corneal staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week|Baseline, 12-hours, 1-week||||units on a scale|Participants|Standard Deviation|Mean
2634740|NCT01809834|Secondary|Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen)|"Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at low lighting conditions (low illumination).~(logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week."|Insertion, 12-hours, 1-week||||logMAR|Participants|Standard Deviation|Log Mean
2634741|NCT01809834|Secondary|Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen)|"Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at normal lighting conditions (high illumination).~(logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week."|Insertion||||logMAR|Participants|Standard Deviation|Log Mean
2634742|NCT01809834|Primary|Participant's Subjective Rating of Overall Preference (Questionnaire)|Participants rated their overall lens preference by questionnaire. (annotated scale, 0-100, scale normalized to 0=no preference, +50=strongly prefers test lens, -50=strongly prefers control lens). Change over time measured at 12-hours, 1-week|12-hours, 1-week||||score on a scale||Standard Deviation|Mean
2634743|NCT01809834|Primary|Participant's Subjective Rating of Visual Quality (Questionnaire)|Participants rated visual quality of the lenses by questionnaire (annotated scale, 0-100, 0=extremely poor vision all of the time. Cannot function, 100=excellent vision all of the time) Change over time measured at 12-hours, 1-week|12-hours, 1-week||||units on a scale|Participants|Standard Deviation|Mean
2634744|NCT01809834|Primary|Participant's Subjective Rating of Lens Handling for Removal (Questionnaire)|Participants rated their lens handling experience for the lens removal by questionnaire (un-annotated scale, 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye) Change over time measured at 12-hours, 1-week|12-hours, 1-week|One participant temporarily discontinued from study after 12-hour visit. (n=43 at 1-week visit)|||units on a scale|Participants|Standard Deviation|Mean
2634745|NCT01809834|Primary|Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire)|Participants rated their lens handling experience for lens insertion by questionnaire (un-annotated scale, 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye) Measured at Dispensing|Dispense||||score on a scale|Participants|Standard Deviation|Mean
2634746|NCT01809834|Primary|Participant's Subjective Rating of Dryness (Questionnaire)|Participants rated dryness of the lenses by subjective questionnaire (annotated scale, 0-100, 0=cannot be worn / extremely dry, 100=no dryness experienced at any time) Change over time measured at 12-hours, 1-week|12-hours, 1-week||||units on a scale|Participants|Standard Deviation|Mean
2634747|NCT01809834|Secondary|Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy)|"Investigators assigned an overall fit acceptance grade by biomicroscopy assessment (grading scale, 0-4, 0=very poor, 4=very good).~Change over time measured at insertion, 12-hours, 1-week"|Insertion, 12 hours, 1 week||||units on a scale|Participants|Standard Deviation|Mean
2634748|NCT01809834|Secondary|Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy)|"Investigators assigned a lens surface wettability grade by biomicroscopy assessment (grading scale, 0 to 4, 0=excellent, 4=severely reduced).~Change over time measured after lens settling (insertion), after 12-hours wear on the dispense day (12-hours), after a minimum on one hour of lens wear at 1 week (1-week)."|Insertion, 12 hours, 1 week||||units on a scale|Participants|Standard Deviation|Mean
2634749|NCT01809834|Primary|Participant's Subjective Rating of Comfort (Questionnaire)|Participants rated their comfort of lenses by subjective questionnaire (un-annotated scale, 0-100, 0=Poor comfort/intolerable, 100=Excellent comfort/cannot be felt) Change over time measured at insertion, After settling, 12-hours, 1-week|Insertion, After Lens settling, 12-hours, 1-week|One participant temporarily discontinued from study after 12-hour visit. (n=43 at 1-week visit)|||units on a scale|Participants|Standard Deviation|Mean
2634750|NCT01809639|Primary|Time (in Days) That a Patient Reports Symptoms From Their Concussion.|The total time that a patient reports symptoms will be assessed. Once the patient reports that they are asymptomatic, the patient will repeat the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) test to determine if the patient's score has returned to baseline.|From date of injury until date asymptomatic, assessed up to 24 months||||Days Symptomatic||Standard Error|Mean
2634751|NCT01809327|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.|Up to 30 weeks of last study drug administration|Safety Analysis Set included all randomized participants who received at least 1 dose of double-blind study drug.|||participants|||Number
2634752|NCT01809327|Secondary|Percent Change in Triglycerides From Baseline to Week 26|The percentage change in triglycerides from baseline to Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
2634753|NCT01809327|Secondary|Percent Change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26|The percentage change in Fasting High-Density Lipoprotein Cholesterol (HDL-C) from baseline to Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"Analysis used mITT analysis set (all randomized patients who received at least 1 dose of study drug). Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."|||percent change||Standard Error|Least Squares Mean
2634754|NCT01809327|Secondary|Change in Systolic Blood Pressure From Baseline at Week 26|The change in systolic blood pressure from baseline at Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."|||millimeter of mercury (mm Hg)||Standard Error|Least Squares Mean
2634755|NCT01809327|Secondary|Percentage of Participants With Glycated Hemoglobin (HbAIc) Less Than 7 Percent at Week 26|The percentage of participants achieved HbAIc less than 7 percent at Week 26 was compared between the different treatment groups.|Week 26|"This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2634756|NCT01809327|Secondary|Percent Change in Body Weight From Baseline to Week 26|The percentage change in body weight from baseline to Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."|||percent change||Standard Error|Least Squares Mean
2634757|NCT01809327|Primary|Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26|The change in the value of glycated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) from baseline at Week 26 was compared between the different treatment groups.|Day 1 (Baseline) and Week 26|"This analysis was conducted using the modified intent-to-treat analysis set, which included all participants who were randomly assigned to a treatment group and received at least 1 dose of study drug. Here N (Number of Participants Analyzed) signifies number of Participants who were evaluable for this outcome measure."|||percentage of hemoglobin||Standard Error|Least Squares Mean
2634758|NCT01809314|Secondary|Percentage of Participants Who Required Blood Transfusions During the Study|The percentage of participants who required blood transfusions was reported at each assessment visit and was based on the 1-month period preceding the respective visit.|Baseline to Month 1, Month 1 to 2, Month 2 to 3, Month 3 to 4|"All Participants Enrolled. The Number of Participants Analyzed reflects the total combined number of participants who provided data for the endpoint. The number of participants who provided data for the analysis at each timepoint (n) is shown in the table."|||percentage of participants|||Number
2634759|NCT01809314|Secondary|Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT|"ECOG performance status was determined at Baseline and at the EOT visit at Month 4. The assessment used a 3-point scale, including scores of 0 (fully active/able to carry on all pre-disease activities without restriction), 1 (restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work), or 2 (ambulatory for more than 50% of waking hours and capable of all self care but unable to carry out any work activities). The traditional 6-point scale was not valid because only participants with a performance status of 0, 1, or 2 were eligible for the study. The percentage of participants by change in ECOG performance status was reported. For example, the percentage of participants with ECOG performance status of 0 at Baseline and 2 at EOT is shown in the table as Baseline 0, EOT 2. Transition to a lower performance status indicates improved/increased independence."|Baseline, Month 4|"All Participants Enrolled; only those who provided data at all study visits were included in the analysis. The Number of Participants Analyzed reflects the total combined number of participants who provided data for the endpoint. The number of participants used in the denominator for each calculation (n) was based on the ECOG status at Baseline."|||percentage of participants|||Number
2634760|NCT01809314|Primary|Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT)|The change in Hb level from Baseline to the EOT visit at Month 4 was averaged among all participants and expressed in grams per liter (g/L).|Baseline, Month 4|All Participants Enrolled; only those who provided data at all study visits were included in the analysis.|||g/L||95% Confidence Interval|Mean
2634761|NCT01809262|Secondary|Laboratory Testing: Average Change From Baseline of Potassium and Calcium|Laboratory testing: Average change from baseline of potassium and calcium measured on test-days|Baseline and Visit 6|Safety set.|||mmol/L||Inter-Quartile Range|Geometric Mean
2634762|NCT01809262|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG|Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).|2 weeks|Safety set|||percentage of participants|||Number
2634763|NCT01809262|Secondary|Number of Patients Requiring Rescue Medication on a Test-day|Number of Patients Requiring Rescue Medication on a Test-day. Salbutamol inhalation aerosol MDI (Ventolin®, 100 μg/actuation) was provided for use as rescue medication. Administration of rescue medication can occur at any point during the pulmonary function testing as deemed necessary by the patient or the investigator.|Visits 1,2,4,5,6|Safety set which consisted of all randomised patients who had taken at least one dose of study medication.|||Number of Patients|||Number
2634764|NCT01809262|Secondary|Time to Onset of Response|Onset of the bronchodilator response after a single dose of study treatment was defined as the linear interpolation of the time of the first bronchodilator response and the time of the observation just prior to the first bronchodilator response (even if that is the baseline observation). If none of the FEV1 values in the first 3 hours after dosing exceeded 12% of the pre-dose value, then the onset was set to 3 hours plus 1 minute.|0 to 3 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint.|||minutes||Standard Deviation|Mean
2634765|NCT01809262|Secondary|Time to Peak Bronchodilator Response|A bronchodilator response was considered to have been achieved if an FEV1 measurement of at least 12% greater than the test-day baseline value was recorded at any time during the first 3 hours of observation after dosing.|0 to 3 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint.|||minutes||Standard Deviation|Mean
2634768|NCT01809262|Secondary|FEV1 AUC 12 - 24 Hours|The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from 12 hours to 24 hours, using the trapezoidal rule divided by 12 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.|12h, 14h, 22h, 23h and 24h post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint|||L||Standard Error|Mean
2634769|NCT01809262|Secondary|FEV1 AUC 0 - 24 Hours|The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 24 hours, using the trapezoidal rule divided by 24 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.|-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint|||L||Standard Error|Mean
2634770|NCT01809262|Secondary|FEV1 AUC 0 - 12 Hours|The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 12 hours, using the trapezoidal rule divided by 12 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.|-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint|||L||Standard Error|Mean
2634771|NCT01809262|Secondary|FEV1 AUC 0 - 3 Hours|The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 3 hours, using the trapezoidal rule divided by 3 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.|-10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data available for this endpoint|||L||Standard Error|Mean
2634772|NCT01809262|Primary|Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment|Forced expiratory volume in one second (FEV1) at 24 hours after a single-dose of study treatment. Means are adjusted with test-day baseline, patient, treatment, and period as fixed effects. Test-day baseline value was defined as the value at 10 minutes before inhalation of study medication.|24 hours post-dosing|Full Analysis Set (FAS): The FAS consisted of all treatment periods with baseline data and post-dosing data for FEV1 at 24 hours.|||L||Standard Error|Mean
2634773|NCT01809210|Secondary|CL/F|Apparent oral plasma clearance|Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose|Pharmacokinetic analysis set - patients with sufficient samples to provide an adequate PK profile for determination of PK parameters with no important adverse events or protocol deviations that may have impacted PK|||L/h||Standard Deviation|Mean
2634774|NCT01809210|Secondary|Tmax,ss|Time to reach maximum plasma concentration at steady state|Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose|Pharmacokinetic analysis set - patients with sufficient samples to provide an adequate PK profile for determination of PK parameters with no important adverse events or protocol deviations that may have impacted PK|||h||Full Range|Median
2634775|NCT01809210|Secondary|Cmax,ss|Maximum plasma concentration at steady state|Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose|Pharmacokinetic analysis set - patients with sufficient samples to provide an adequate PK profile for determination of PK parameters with no important adverse events or protocol deviations that may have impacted PK|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2634776|NCT01809210|Secondary|AUC (0-tau)|Area under the concentration time curve (AUC) over a dosing interval at steady state (0-tau)|Cycle 2 Day1, pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 hours post dose|Pharmacokinetic analysis set - patients with sufficient samples to provide an adequate PK profile for determination of PK parameters with no important adverse events or protocol deviations that may have impacted PK|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2634777|NCT01809210|Secondary|Objective Response Rate (ORR)|The number of patients who had at least 1 confirmed visit response of Complete Response (CR) or Partial Response (PR) prior to any evidence of progression. Per Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm; Objective Response Rate (ORR) = CR + PR|Up until progression or last evaluable assessment in the absence of progression, up to 9 months|Tumour response analysis set - dosed patients with a baseline tumour assessment.|||participants|||Number
2634778|NCT01809210|Secondary|Best Percentage Change From Baseline in Target Lesion Size|The best percentage change in tumour size a patient has had during their time in the study up until RECIST progression or last valuable assessment in the absence of RECIST progression. Percentage change was derived at each visit by the percentage change in the sum of the diameters of target lesions|Screening, week 6 and week 12|Tumour response analysis set - dosed patients with a baseline tumour assessment.|||% change||Standard Deviation|Mean
2634779|NCT01809210|Secondary|Percentage Change From Baseline at 6 Weeks in Target Lesion Size|The percentage change in the sum of the diameters of target lesions|Week 6|Tumour response analysis set - dosed patients with a baseline tumour assessment.|||% change||Standard Deviation|Mean
2634780|NCT01809210|Secondary|Best Objective Response|The best response a patient has had during their time in the study up until RECIST progression or last valuable assessment in the absence of RECIST progression. Per Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions, the sum must also demonstrate an absolute increase of >=5mm; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm|Screening, week 6 and week 12|Tumour response analysis set - dosed patients with a baseline tumour assessment.|||participants|||Number
2634781|NCT01809210|Primary|Dose Limiting Toxicity (DLT) Events in Chemotherapy in Combination With Selumetinib|Any toxicity not attributable to the disease or disease-related processess under investigation, considered related to the combination of chemotherapy plus selumetinib, which occurs within the timeframe and is dose limiting|The first dose on Cycle 1 Day 1 up to the time before dosing on Cycle 2 Day 1, assessed up to 3 weeks|Safety analysis set - all patients who received at least 1 dose of selumetinib.|||participants|||Number
2634782|NCT01809197|Primary|"Likert Scale Questionnaire Item: I Can Comfortably Wear my Lenses"|Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree.|Day 30; after 4 hours of lens wear|This analysis population includes all subjects who were randomized and received study regimen (test or control) with a Day 30 response to this Likert item.|||units on a scale||Standard Deviation|Least Squares Mean
2634783|NCT01809106|Other Pre-specified|The Opioid Escalation Index|The proportion of subjects with an increase of opioid daily dose > 5% compared with the basal dosage (OEI%).|28 days||||participants|||Number
2634784|NCT01809106|Secondary|Proportion of Full-responder|Evaluation of the proportion of subjects who report full analgesia (full responders: FR). FR is operationally defined as a patient with a P.I.D. =/> 30% from visit 6 and visit 1 (NRS 0 to 10).|28 days||||participants|||Number
2634785|NCT01809106|Primary|Proportion of Non-Responder (NR) Participants|"Evaluation of the proportion of Non-Responder (NR) participants. NR correspond to the subjects who do not report any analgesic effects, with a P.I.D. (pain intensity difference) from visit 6 and visit 1 =/< 0%, (using a 0-10 NRS ). It includes the situations of average pain intensity stable or worsened at day 28 compared with baseline values."|28 days|Intention-to-treat|||participants|||Number
2634786|NCT01809054|Secondary|Deep Vein Thrombosis|verified by ultrasound|6 weeks||||participants|||Number
2634787|NCT01809054|Primary|Blood Loss|requiring transfusion|6 weeks||||participants|||Number
2634788|NCT01808963|Primary|Evaluation of Respiratory Heat Loss as a Physiologic Patient Monitor for Acute Care Medicine|Respired gas heat content|1 year.||||Joules per minute||Standard Deviation|Mean
2634789|NCT01808950|Secondary|Global Judgment of Tolerability by Investigator by Means of a 6-point Scale||8 weeks after a maximal treatment period of 4 weeks|||||||
2634790|NCT01808950|Secondary|Evaluation of Systemic Tolerability Based on Haematology and Blood Chemistry Values and Vital Signs||up to 12 weeks|||||||
2634791|NCT01808950|Secondary|Evaluation of Local Tolerability by Means of 5-point Scales|local skin reactions as erythema, edema, erosion/ulceration, exudate, dryness, encrustation judged by investigator by means of 5-point scales (0 = absent, 1 = slight, 2 = moderate, 3 = severe, 4 = very severe).|up to 12 weeks|||||||
2634792|NCT01808950|Secondary|Complete Clinical Clearance Rate||8 weeks after the 4 weeks treatment period|data were not collected for any of study participant.||||||
2634793|NCT01808950|Primary|Histological Cure Rate||8 weeks after a maximal treatment period of 4 weeks|data were not collected for any of study participant.||||||
2634794|NCT01808794|Secondary|Alveolar Bone Height|Compare clinically, radiographically, and histologically MucograftTM with DynamatrixTM in relation to changes of the alveolar bone height at the extraction site.|4-6 Months after surgical procedure|The Study PI has passed away. All efforts to locate study data have been exhausted and there is no study data available.||||||
2634795|NCT01808794|Primary|Compare Barrier Membranes by Examining Keratinized Tissue|The primary aim is to compare MucograftTM when used as a barrier membrane in the ridge preservation technique to increase or preserve the thickness and width of keratinized tissue at the extraction site in comparison to DynamatrixTM.|4-6 Months after surgical procedure|The Study PI has passed away. All efforts to locate study data have been exhausted and there is no study data available.||||||
2634796|NCT01808755|Primary|Days|time required to develop the next urinary tract infection; evaluation by means of urine analysis and urine culture|168||||days||Standard Deviation|Mean
2634797|NCT01808690|Other Pre-specified|Change in Brachial Artery Distensibility|"Hypothesis 2a: Metformin will improve peripheral arterial stiffness in Type 1 Diabetes via Dynapulse.~Peripheral arterial stiffness is measured by the distensibility of the arterial wall. Increased arterial stiffness results from reduced elasticity of the arterial wall.~A higher result is a better outcome."|Baseline, Month 3|Metformin: 1 lost to follow-up Placebo: 2 lost to follow-up|||%/mmHg||Standard Deviation|Mean
2634798|NCT01808690|Secondary|Change in Aortic Wall Sheer Stress (WSS)|"Hypothesis 2a: Metformin will improve central vascular function in Type 1 Diabetes via Aortic Wall Sheer Stress (WSS) by MRI. WSS is a measure of central arterial stiffness.~A lower value indicates a better outcome."|Baseline, Month 3|Number of participants analyzed differs from participant flow numbers because the institution's MRI scanner was unavailable during replacement.|||dyne/cm2||Standard Deviation|Mean
2634799|NCT01808690|Secondary|Change in Cardiac Function by Echocardiogram|Hypothesis 2b: Metformin will improve cardiac function in Type 1 Diabetes by echocardiogram.|Baseline, Month 3||2020-06-30|06/2020||||
2634800|NCT01808690|Secondary|Change in Central Arterial Intimal Medial Thickness (cIMT)|"Hypothesis 2a: Metformin will improve central vascular function in Type 1 Diabetes via central arterial intimal medial (cIMT) thickness by carotid ultrasound. cIMT is a measure used to diagnose the extent of carotid atherosclerotic vascular disease. The test measures the thickness of the inner two layers of the carotid artery—the intima and media.~A lower result is a better outcome."|Baseline, Month 3|Metformin: 1 lost to follow-up Placebo: 2 lost to follow-up|||mm||Standard Deviation|Mean
2634801|NCT01808690|Secondary|Change in Pulse Wave Velocity (PWV)|"Hypothesis 2a: Metformin will improve central vascular function in Type 1 Diabetes via pulse wave velocity (PWV) by MRI. PWV is a measure of central arterial stiffness.~A lower value indicates a better outcome."|Baseline, Month 3|Number of participants analyzed differs from participant flow numbers because the institution's MRI scanner was unavailable during replacement.|||m/s||Standard Deviation|Mean
2634802|NCT01808690|Secondary|Change in ADP Time Constant|"Hypothesis 1b: Metformin will improve mitochondrial function in Type 1 Diabetes. 31Phosphorus magnetic resonance spectroscopy (MRS) was used before, during, and after 90 seconds of near-maximal isometric exercise of the calf muscle for post-exercise muscle mitochondrial function. ADP time constant is the time for conversion of ADP → ATP and is a measure of muscle mitochondrial health (energy metabolism).~A faster recovery is a better outcome; a slower recovery is a worse outcome."|Baseline, Month 3|22 participants had both pre/post MRS data|||seconds (s)||Inter-Quartile Range|Median
2634803|NCT01808690|Primary|Change in Insulin Sensitivity|Hypothesis 1: Metformin will improve insulin function in Type 1 Diabetes. Insulin function will be measured using a euglycemic-hyperinsulinemic clamp procedure at both baseline and after 3 months of treatment. A clamp measures insulin sensitivity. A higher number indicates a better outcome; a lower number indicates a worse outcome.|Baseline, Month 3|Metformin group: 1 participant lost to follow-up, 1 IV access problem Placebo group: 2 lost to follow-up, 2 IV access problems|||(mg/kg/min)/(insulin)||Standard Deviation|Mean
2634804|NCT01808651|Secondary|Change From Baseline to Week 52 in Sheehan Disability Scale (SDS) Total Score and Subscale Scores|SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/school (Item 1), social life/leisure activities (Item 2), and family life/home responsibilities (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, pooled investigative site, and baseline SDS score.|Baseline up to 52 weeks|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline SDS score. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.|||units on a scale||Standard Error|Least Squares Mean
2634805|NCT01808651|Secondary|Mean Change From Baseline to Week 52 on the HAMD21 Subscale Scores|HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score.|Baseline, Week 52|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 subscale score. LSM (least square mean) and SE (standard error) are from visit 16.|||units on a scale||Standard Error|Least Squares Mean
2634806|NCT01808651|Secondary|Mean Change From Baseline to Week 52 on the Clinical Global Impression of Severity (CGI-S) Scale|CGI-S measures severity of illness at the time of assessment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline CGI-S score.|Baseline, Week 52|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline CGI-S score during the Treatment Period.|||units on a scale||Standard Error|Least Squares Mean
2634807|NCT01808651|Secondary|Percentage of Participants Achieving a Remission at Week 52|The percentage of participants achieving a remission (defined as a HAMD21 total score ≤7) was calculated by dividing the number of participants achieving a remission at last observation by the total number of participants at risk, multiplied by 100.|up to Week 52|Participants who received at least 1 dose of study drug with a baseline (which had not achieved remission threshold criteria) and had at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.|||percentage of participants|||Number
2634808|NCT01808651|Secondary|Percentage of Participants Achieving a Response at Week 52|The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100.|Baseline, up to Week 52|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.|||Percentage of participants|||Number
2634809|NCT01808651|Secondary|Mean Change From Baseline to Week 52 on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score|HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.|Baseline, Week 52|Participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during Study Period 1.|||units on a scale||Standard Error|Least Squares Mean
2634810|NCT01808651|Primary|Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)|"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation."|Baseline through Week 52|Participants who received at least 1 dose of study drug with at least 1 post-baseline C-SSRS score during Study Period 1.|||participants|||Number
2634811|NCT01808651|Primary|Number of Participants With Adverse Events (AEs) or Serious AEs (SAEs)||Baseline through Week 52.|Participants who received at least 1 dose of the study drug were evaluated for AEs and SAEs. SAE reported for 1 participant (FLX20/FLX) was a pre-existing condition prior to Study Period 1 that became an SAE after Study Period 1.|||participants|||Number
2634948|NCT01808209|Primary|Dryness|Participant rating of lens dryness. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable, 100=extreme comfort/ cannot feel them at all)|Baseline|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||units on a scale||Standard Deviation|Mean
2634812|NCT01808612|Secondary|Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)|"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a yes answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation."|Baseline through 6 weeks|Randomized participants who received at least 1 dose of study drug with at least 1 post-baseline C-SSRS score during the Treatment Period.|||participants|||Number
2634813|NCT01808612|Secondary|Mean Change From Baseline to 6-Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores|SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/school (Item 1), social life/leisure activities (Item 2), and family life/home responsibilities (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, pooled investigative site, and baseline SDS score.|Baseline, up to 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline SDS score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only postbaseline data.|||units on a scale||Standard Error|Least Squares Mean
2634814|NCT01808612|Secondary|Mean Change From Baseline to 6-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale|CGI-S measures severity of illness at the time of assessment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline CGI-S score.|Baseline, 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline CGI-S score during the Treatment Period.|||units on a scale||Standard Error|Least Squares Mean
2634815|NCT01808612|Secondary|Percentage of Participants Achieving a Remission at 6-Week Endpoint|The percentage of participants achieving a remission (defined as a HAMD21 total score ≤7) was calculated by dividing the number of participants achieving a remission at last observation by the total number of participants at risk, multiplied by 100.|up to 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline (which had not achieved remission threshold criteria) and had at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.|||percentage of participants|||Number
2634816|NCT01808612|Secondary|Percentage of Participants Achieving a Response at 6-Week Endpoint|The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100.|up to 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.|||percentage of participants|||Number
2634817|NCT01808612|Secondary|Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores|HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score.|Baseline, 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 subscale score during the Treatment Period.|||units on a scale||Standard Error|Least Squares Mean
2634818|NCT01808612|Primary|Mean Change From Baseline to 6-Week Endpoint on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score|HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.|Baseline, 6 weeks|Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period.|||units on a scale||Standard Error|Least Squares Mean
2634819|NCT01808573|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events)|Adverse Events to be measured are Treatment-Emergent and Serious AEs that occurred on or after first dose of investigational product and up to 28 days after the last dose|From first dose through last dose + 28 days, up to 41 months. The result is based on final data cut.|Safety population: Participants receiving at least 1 dose of investigational product.|||percentage of participants|||Number
2634837|NCT01808534|Primary|Overall Response Rate (Defined as Partial Response or Complete Response)|The percent of patients who were shown as having a partial remission or better based on definitions of response in RECIST 1.1. At least a 30% decrease in the sum of the diameters of target lesions, in reference to baseline sum diameters, needs to be confirmed to be considered as partial response or better. Note: There were no patients with a partial or complete response.|Up to 2 years|All patients who enrolled and received treatment with at least one post baseline assessment.|||percentage of participants||95% Confidence Interval|Number
2634820|NCT01808573|Secondary|Duration of Response (DOR) - Central Assessment (Population That Had a Response With Measurable Disease at Screening)|"The Duration of Response (DOR) is for Central Assessment for the Population that Had a Response with Measurable Disease at Screening.~Duration of response is measured from the time at which measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per RECIST v1.1. This value is censored at the last valid tumor assessment if PD or death has not been documented."|From start date of response after randomization to first PD, up to 33 months.The result is based on primary analysis data cut.||||months||95% Confidence Interval|Median
2634821|NCT01808573|Secondary|Clinical Benefit Rate (CBR) - Central Assessment (ITT Population With Measurable Disease at Screening)|Clinical benefit rate is the percentage of participants who achieve overall tumor response (confirmed CR or PR) or stable disease (SD) lasting for at least 24 weeks from randomization. The CBR was for Central Assessment for subjects who had Measurable Disease at Screening.|From randomization date to either first confirmed CR or PR or Stable Disease, whichever came earlier, up to 42 months.The result is based on primary analysis data cut.||||percentage of participants||95% Confidence Interval|Number
2634822|NCT01808573|Secondary|Objective Response Rate (ORR) - Central Assessment (ITT Population With Measurable Disease at Screening)|Objective response rate is defined as the percentage of participants demonstrating an objective response during the study. Objective response includes confirmed complete responses (CR) and partial responses (PR) as defined in the RECIST criteria included in the study protocol. The ORR is for Central Assessment for subjects that had measurable disease at screening. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From randomization date to first confirmed Complete or Partial Response, whichever came earlier, up to 42 months.The result is based on primary analysis data cut.||||percentage of participants||95% Confidence Interval|Number
2634823|NCT01808573|Secondary|Intervention for Symptomatic Metastatic Central Nervous System Disease|Intervention for symptomatic metastatic central nervous system disease is defined as the time from randomization to the first start date of an intervention for symptomatic metastatic CNS disease. Subjects that do not have an intervention for symptomatic metastatic CNS and do not die will be censored at the last date known alive on or prior to the data cutoff. Deaths are treated as competing events. Percentage of participants with intervention for CNS, estimated by cumulative incidence methods. Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring.|From randomization date to first intervention for symptomatic metastatic CNS disease, assessed up to 59 months.The result is based on primary analysis data cut.||||percentage of participants||95% Confidence Interval|Number
2634824|NCT01808573|Primary|Overall Survival|Overall survival (OS) is defined as the time from randomization to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to 48 months.|From randomization date to death, assessed up to 59 months.The result is based on primary analysis data cut.||||months||95% Confidence Interval|Mean
2634825|NCT01808573|Primary|Centrally Assessed Progression Free Survival|Progression Free Survival (PFS), Measured in Months, for Randomized Subjects of the Central Assessment. The time interval from the date of randomization until the first date on which recurrence, progression (per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1), or death due to any cause, is documented. For subjects without recurrence, progression or death, it is censored at the last valid tumor assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to 24 months.|From randomization date to recurrence, progression or death, assessed up to 38 months. The result is based on primary analysis data cut.|Randomized ITT Population|||months||95% Confidence Interval|Mean
2634826|NCT01808560|Other Pre-specified|Mean Change in Tear Break-up Time (TBUT)|"The Investigator or designee measures tear break-up time (TBUT) under a slit-lamp biomicroscope following instillation of fluorescein dye in the eye using the Dry Eye Test (DET) method.~Tear film break-up is defined as the first observed break-up of the tear film following the third blink. Using a stopwatch to record the time, start the stopwatch as soon as the subject opens his/her eyes after the third blink and stop the stopwatch when the first break-up of the tear film is observed.~Any values recorded as greater than 20 seconds were converted to 20 seconds in the analysis. Three separate measurements were taken for each eye and were averaged for analysis. A higher tear break-up time indicates better tear film stability."|Baseline and 3 Months post-surgery|Intent to Treat (ITT) Population of all randomized subjects.|||Change in TBUT (in seconds)|Eyes|Standard Deviation|Mean
2634827|NCT01808560|Other Pre-specified|Mean Change in Number of MGYLS (Meibomian Glands Yielding Liquid Secretion)|"Meibomian gland assessment was performed to evaluate the function of the meibomian glands based on the secretion characteristics from the gland orifices along the lower eyelid at the visits. Under a slit-lamp biomicrosope, the gland orifices were evaluated using a handheld instrument, Meibomian Gland Evaluator, to apply gentle pressure along the eyelid margin. This instrument provided a standardized method of applying the same amount of pressure at each visit and for each eye to ensure measurement consistency.~The number of meibomian glands yielding liquid secretion (MGYLS) (i.e., cloudy or clear liquid with a grade of 2 or 3) was counted out of the 15 glands assessed with a range of 0 to 15. A higher total meibomian gland score or higher number of MGYLS reflects less meibomian gland dysfunction."|Baseline and 3 Months post-surgery|Intent to Treat (ITT) Population of all randomized subjects.|||Change in Number of MGYLS|Eyes|Standard Deviation|Mean
2634838|NCT01808508|Secondary|Change in the Distance Walked on a 6 Minute Walk Test From Baseline to 4 Months|As secondary outcome of the second aim, we will use the distance walked during the 6 minute walk test.|4 Months|The majority of subjects were unable to follow instructions properly and therefore none could successfully complete the test. Thus the results were not considered to be valid.||||||
2634828|NCT01808560|Other Pre-specified|Mean Change in NEI-VFQ Questionnaire Score From Baseline at 3 Months|"The National Eye Institute Visual Function Questionnaire (NEI-VFQ) evaluates frequency or severity of a symptoms and the effect on activities of daily living.~The questionnaire has an overall score and 12 subscale scores for general health, general vision, ocular pain, difficulty with near vision activities, difficulty with distance vision activities, social functioning limitations due to vision, mental functioning limitations due to vision, role limitations due to vision, dependency on others due to vision, driving difficulties, color vision and peripheral vision.~The NEI-VFQ scores range from 0 to 100 with lower scores indicating more symptoms or difficulty with activities of daily living. The questionnaire is scored by recoding responses to set values on a 0 to 100 scale such that the lowest value is set to 0 and the highest value is set to 100. The overall score is the average of vision subscale scores, excluding general health question."|Baseline and 3 Months post-surgery|Intent to Treat (ITT) Population of all randomized subjects.|||Change in NEI-VFQ-25 Composite Score||Standard Deviation|Mean
2634829|NCT01808560|Other Pre-specified|Mean Change in Ocular Surface Disease Index (OSDI) Questionnaire Score From Baseline at 3 Months|Dry eye symptoms assessed using the OSDI questionnaire are sensitivity to light, grittiness, pain or soreness, blurred vision and poor vision. The assessment considers the frequency that problems with the eyes limit performance in reading, driving at night, working with a computer or bank machine, and watching television. Also, the frequency that eyes feel uncomfortable is assessed in windy conditions, areas with low humidity, and air-conditioned areas. The frequency scale is: 0 (none of the time), 1 (some of the time), 2 (half of the time), 3 (most of the time) and 4 (all of the time). The subject can answer not applicable (N/A) if the subject did not experience the situation or condition in the past week. Total OSDI score is calculated as the sum of frequency scores for all symptoms multiplied by 25 and divided by the number of questions answered with a range from 0 to 100. A lower OSDI score represents less disability from dry eye symptoms.|Baseline and 3 Months post-surgery|Intent to Treat (ITT) Population of all randomized subjects.|||Change in Total OSDI Score||Standard Deviation|Mean
2634830|NCT01808560|Secondary|Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months|Assess for reduction in dry eye symptoms in symptomatic contact lens after LipiFlow treatment in comparison to an untreated control using Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire. It was defined as the mean change in SPEED score in the LF Treatment group compared to Control group from Baseline to 3 Months. The symptoms assessed are dryness, grittiness / scratchiness; soreness / irritation; burning / watering; and eye fatigue. Symptom frequency is on a scale of: 0 (never), 1(sometimes), 2 (often) and 3 (constant). Symptom severity is on a scale of: 0 (no problems), 1 (tolerable-not perfect but not uncomfortable), 2 (uncomfortable-irritating but does not interfere with my day), 3 (bothersome-irritating and interferes with my day) and 4 (intolerable-unable to perform my daily tasks). SPEED score is calculated as sum of frequency and severity scores for symptoms over a range from 0 to 28. A lower SPEED score represents less frequent and/or less severe symptoms.|Baseline and 3 Months post-surgery|Intent to Treat (ITT) Population of all randomized subjects.|||Change in SPEED Score||Standard Deviation|Mean
2634831|NCT01808560|Primary|Mean Change in Total Meibomian Gland Score|"The primary endpoint is the mean change in total meibomian gland score in the Pre-treatment group compared to the Untreated group from Baseline after cataract surgery.~Meibomian gland assessment was performed to evaluate the function of the meibomian glands based on the secretion characteristics from the gland orifices along the lower eyelid. Under a slit-lamp biomicrosope, the gland orifices were evaluated using a handheld instrument, Meibomian Gland Evaluator. This instrument provided a standardized method of applying the same amount of pressure and for each eye to ensure measurement consistency. A total of 15 glands were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range of 0 to 45."|Baseline and 3 Months post-surgery|Intent to Treat (ITT) Population of all randomized subjects.|||Change in Meibomian Gland Score|Eyes|Standard Deviation|Mean
2634832|NCT01808547|Primary|Ocular Inflammation|"Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells, and no rescue medications."|15 days|Modified Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method.|||participants|||Number
2634833|NCT01808534|Secondary|Treatment Related Adverse Events Grade 3 or Higher|Number of unique patients who had a treatment related (possible, probable or definite) adverse event that was graded 3 or greater according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03.|Up to 2 years|All patients who enrolled and received treatment.|||participants|||Number
2634834|NCT01808534|Secondary|Overall Survival|Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Time until death or last evaluation will be calculated. If a patient did not die, they will be censored in the analysis at their last known alive date.|Up to 2 years|All patients who enrolled and received treatment.|||months||90% Confidence Interval|Median
2634835|NCT01808534|Secondary|Progression Free Survival (PFS)|Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Time until progression, death or last evaluation will be calculated. If a patient did not progress or die, they will be censored at their last evaluation in the analysis.|Up to 2 years|All patients who enrolled and received treatment.|||months||90% Confidence Interval|Median
2634836|NCT01808534|Secondary|Duration of Remission in Patients Who Achieve a Partial or Complete Response|The duration of remission is from the time of confirmed partial or complete response until progression or death. Patients continuing in remission at the end of the study will be treated as censored. Summarized by Kaplan-Meier methods including 90% confidence intervals for the median using method of Brookmeyer and Crowley. Note: There were no patients who achieved partial or complete response.|Up to 2 years||||months||90% Confidence Interval|Median
2634893|NCT01808313|Secondary|Change From Baseline in 6MWT at Week 24|The 6MWT measures the distance that a participant can walk in a period of 6 minutes. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Baseline 6MWT comprised of an average of the last two consecutive measurements prior to dosing that varied by not greater than 10%. If only one measurement was available, that measurement was used as the Baseline value. The last observation carried forward method was used to impute missing values.|Baseline and Week 24|ITT Population.|||Meters||Standard Deviation|Mean
2634839|NCT01808508|Secondary|Change in the Left Ventricular (LV) Mass Index Score From Baseline to 4 Months|The change in left ventricular mass index score, measured on echocardiography, was used to assess the relationship between obstructive sleep apnea syndrome and cardiovascular function of individuals with Down syndrome. Left ventricular (LV) mass was calculated from M-mode measurements of the LV end-diastolic dimension, the thickness of the interventricular septum and the thickness of the LV posterior wall, and presented as a z-score.|4 Months|1 OSAS subject randomized to CPAP did not return for follow-up|||z-score||Inter-Quartile Range|Median
2634840|NCT01808508|Secondary|Change in Child Behavior Checklist (CBCL) Total Score From Baseline to 4 Months|The change in behavioral domain was measured by the Child Check Behavior List. The CBCL is a widely used method of identifying problem behavior in children. Problems are identified by a respondent who knows the child well, usually a parent or other care giver. There are 2 versions based on the child's age (CBCL/1½-5 for use children 18 months-5 years; the CBCL/6-18 for children aged 6-18 years). The checklists consists of a number of statements about the child's behavior and responses are recorded on a scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The preschool checklist contains 100 questions and, school-age checklist contains 120 questions. 8 sub-scores (1 for each of 8 syndromes: anxious/depressed, withdrawn depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior and aggressive behavior) are calculated, each ranging from 0 (normal) to 16 (clinical behavior).|4 Months|1 OSAS subject randomized to CPAP did not return for follow-up|||units on a scale||Inter-Quartile Range|Median
2634841|NCT01808508|Primary|Change in Epworth Sleepiness Scale From Baseline to End of Study|The primary aim of the study is to assess the relationship between obstructive sleep apnea syndrome (OSAS) and the neurocognitive and behavioral outcomes of individuals with Down syndrome. Sleepiness was assessed using the pediatric version of the Epworth Sleepiness Scale (ESS). The ESS is a self-administered questionnaire with 8 questions. It provides a measure of a person's general level of daytime sleepiness, or average sleep propensity in daily life. The ESS asks people to rate, on a 4-point scale (0, low to 3, high) their usual chances of dozing off or falling asleep in 8 different situations or activities that most people engage in as part of their daily lives. The total ESS score provides an estimate of a general characteristic of each person's average level of sleepiness in daily life (0= no chance of dozing/no daytime sleepiness to 24=high chance of dozing/lots of daytime sleepiness).|4 Months|1 OSAS subject randomized to CPAP did not return for follow-up|||units on a scale||Inter-Quartile Range|Median
2634842|NCT01808339|Secondary|Peak Expiratory Flow (PEF)|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. AM and PM pre-treatment PEF was measured throughout the study for the purposes of monitoring participants' asthma stability, and was measured from the start of the Run-in Period until completion of Treatment Period 3 (including during the washout periods), prior to study medication and/or any rescue albuterol/salbutamol inhalation aerosol use. The data collected were only assessed by the Investigator on an individual basis during the study and were not formally summarized or statistically analyzed; consequently, data are not reported.|Up to 18 weeks|||||||
2634843|NCT01808339|Secondary|Number of Participants With Any Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were collected from the start of dosing with investigational product and until follow-up.|Up to 18 weeks|All Subjects Population: all participants who received at least one dose of study medication|||Participants|||Number
2634844|NCT01808339|Secondary|Pre-treatment AM and PM Trough FEV1 on Day 14 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using site equipment (KoKo Pneumotach Spirometer). FEV1 PM trough FEV1 values were the values taken pre-treatment on Day 14, and AM trough FEV1 values were the values taken pre-treatment on Day 15 in each treatment period; thus, there is only one value (pre-treatment record) per period for AM and PM trough.|Day 14 of each treatment period (up to Study Day 105)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication, and had at least one Baseline and post-dose FEV1 measurement performed. Only those participants available at the specified time points were analyzed|||Liters||Standard Error|Least Squares Mean
2634845|NCT01808339|Primary|Weighted Mean Forced Expiratory Volume in 1 Second (FEV1) Measured Over 24 Hours at Day 14 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using site equipment (KoKo Pneumotach Spirometer). Weighted mean FEV1 was calculated using the Day 14 24-hour serial FEV1 measurements taken at 3, 6, 9, 12, 15, 18, 21, and 24 hours post-dose (measured in the evening of Day 15). At each time point, the highest of three technically acceptable measurements was recorded. FEV1 weighted mean was analyzed using a mixed effects analysis of a covariance model with fixed effect terms for treatment and period, participant Baseline, period Baseline, gender, and age as covariates, and participant as a random effect.|24 hours post-PM dose on Day 14 of each treatment period (up to Study Day 105)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication, and had at least one Baseline and post-dose FEV1 measurement performed. Only those participants with non-missing covariates and a post-Baseline FEV1 measurement were analyzed.|||Liters||Standard Error|Least Squares Mean
2634846|NCT01808326|Secondary|Time of Maximum Serum Concentration (Tmax) for Phenyl Acetic Acid Mustard|Blood samples for pharmacokinetic (PK) analysis of chlorambucil and its metabolite phenyl acetic acid mustard were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Time of maximum serum concentration (tmax) was determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hour||Full Range|Median
2636604|NCT01790178|Primary|Number of Patients Receiving Diagnosis From Muscle Biopsy|The rate of achieving a specific final diagnosis in ultrasound guided muscle biopsies vs. unguided biopsies will be examined.|At time of biopsy||||participants|||Number
2634847|NCT01808326|Secondary|Elimination Half-life (t1/2) for Phenyl Acetic Acid Mustard|Blood samples for pharmacokinetic (PK) analysis of chlorambucil and its metabolite phenyl acetic acid mustard were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Elimination half-life (t1/2) was determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hour||95% Confidence Interval|Geometric Mean
2634848|NCT01808326|Secondary|Area Under the Serum Concentration-time (AUC) for Phenyl Acetic Acid Mustard|Blood samples for PK analysis of chlorambucil and its metabolite phenyl acetic acid mustard were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. AUC from time zero up to a definite time t (AUC[0-t]), AUC from time zero up to infinity (AUC[0-inf]), AUC from time zero up to 6 hours post dose (AUC[0-6]), AUC from time zero up to 24 hours post dose (AUC[0-24]) were determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hour*nanogram/ milliliter/milligram||95% Confidence Interval|Geometric Mean
2634849|NCT01808326|Secondary|Maximum Serum Concentration (Cmax), and Minimum Serum Concentration (Cmin) for Phenyl Acetic Acid Mustard|Blood samples for pharmacokinetic (PK) analysis of chlorambucil and its metabolite phenyl acetic acid mustard were collected on Day 1 and Day 4 in Cycle 1, and on Day 1 in Cycle 3. In each sampling, blood samples (2 milliliter [mL]/sample) were collected at pre-dose, and 15 minute (min), 30 min, 1 hour (hr), 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Maximum serum concentration (Cmax), minimum serum concentration (Cmin) were determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 1|PK Population: all participants who received at least one dose of investigational product and for whom PK data was collected. Only those participants with non-missing values available at the specified time points were analyzed (represented by n=X in the category titles).|||Nanograms per milliliter||95% Confidence Interval|Geometric Mean
2634850|NCT01808326|Secondary|Time of Maximum Serum Concentration (Tmax) for Chlorambucil|Blood samples for pharmacokinetic (PK) analysis of chlorambucil were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Time of maximum serum concentration (tmax) was determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hour||Full Range|Median
2634851|NCT01808326|Secondary|Elimination Half-life (t1/2) for Chlorambucil|Blood samples for pharmacokinetic (PK) analysis of chlorambucil were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Elimination half-life (t1/2) was determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hour||95% Confidence Interval|Geometric Mean
2634852|NCT01808326|Secondary|Area Under the Serum Concentration-time (AUC) for Chlorambucil|Blood samples for PK analysis of chlorambucil were collected on Day 1 and Day 4 in Cycle 1, and on Day 57 in Cycle 3. In each sampling, blood samples (2 mL/sample) were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. AUC from time zero up to a definite time t (AUC[0-t]), AUC from time zero up to infinity (AUC[0-inf]), AUC from time zero up to 6 hours post dose (AUC[0-6]), AUC from time zero up to 24 hours post dose (AUC[0-24]) were determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hour*nanogram/ milliliter/milligram||95% Confidence Interval|Geometric Mean
2634876|NCT01808313|Secondary|Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of mean corpuscle volume at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the mean corpuscle volume values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Femtoliters||Standard Deviation|Mean
2634853|NCT01808326|Secondary|Maximum Serum Concentration (Cmax), and Minimum Serum Concentration (Cmin) for Chlorambucil|Blood samples for pharmacokinetic (PK) analysis of chlorambucil were collected on Day 1 and Day 4 in Cycle 1, and on Day 1 in Cycle 3. In each sampling, blood samples (2 milliliter [mL]/sample) were collected at pre-dose, and 15 minute (min), 30 min, 1 hour (hr), 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr post dosing. Maximum serum concentration (Cmax), minimum serum concentration (Cmin) were determined. Between participants coefficient of variation (%CVb) was calculated according to the following methods: Transformed Data : 100 * (square root of the exponential [standard deviation of loge-transformed ]2-1).|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 1|PK Population: all participants who received at least one dose of investigational product and for whom PK data was collected. Only those participants with non-missing values available at the specified time points were analyzed (represented by n=X in the category titles).|||Nanograms per milliliter||95% Confidence Interval|Geometric Mean
2634854|NCT01808326|Secondary|Expression of Complement CH50|Peripheral samples were collected for the analysis of complement CH50 at Baseline (Day 1 of Cycle 1) and after completion of Cycle 4 (Day 85).|Baseline, Cycle 1-Day 1, and Cycle 4-Day 85|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Kilounit /Liter||Standard Deviation|Mean
2634855|NCT01808326|Secondary|Expression of Beta 2 Microglobulin|Blood samples were collected at the Baseline (Day 1 of Cycle 1) visit for prognostic biomarker Beta 2 microglobulin measurements.|Baseline (Cycle 1 Day 1)|All Subjects Population|||Nanomoles per Liter||Standard Deviation|Mean
2634856|NCT01808326|Secondary|Number of Participants With Positive Minimal Residual Disease (MRD)|MRD refers to the small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed CR and in whom bone marrow test was performed. A bone marrow sample was examined by flow cytometry (Cluster of differentiation [CD]5, CD19, CD20, and CD23). MRD positive is defined as more than one CLL cell per 10000 leukocytes.|From the start of treatment up to Week 61.1|All Subjects Population|||Participants|||Number
2634857|NCT01808326|Secondary|Change From Baseline in the Immunoglobulin(Ig) Antibodies IgA, IgG, and IgM|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants.Peripheral samples were collected for the analysis of IgA, IgG, and IgM at Baseline and 28 days after Day 1 of the last treatment cycle (FU 1-PDFU 1) for all participants, and 168 days after day of FU 1-PDFU 1 for participants with CR, PR, and SD. Baseline was the last pre-dose assessment performed on Cycle 1-Day 1. The the last assessment performed prior to pre-dose Cycle 1-Day 1 was used if Cycle 1-Day 1 was missing. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, FU 1-PDFU 1, FU 85-PDFU 85, and FU 169-PDFU 169|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter||Standard Deviation|Mean
2634858|NCT01808326|Secondary|Number of Participants With at Least One Grade 3/Grade 4 Adverse Event of Infection or Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia)|Number of participants with a Grade 3 or Grade 4 adverse event of infection or myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 3.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From the start of treatment up to Week 61.1|All Subjects Population|||Participants|||Number
2634859|NCT01808326|Secondary|Number of Participants With Adverse Events by the Indicated Maximum Toxicity Grade|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. Non-hematologic AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE V4.03): Grade 0, none; Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant; Grade 4, life-threatening consequences; Grade 5, death related to AE|From the start of treatment up to Week 61.1|All Subjects Population|||Participants|||Number
2634860|NCT01808326|Secondary|Number of Participants With Any Adverse Events (AE) or Serious Adverse Events (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, is a congenital anomaly/birth defect or is associated with protocol specified liver injury and impaired liver function or is any protocol specific AEs.|From the start of treatment up to Week 61.1|All Subjects Population|||Participants|||Number
2634861|NCT01808326|Secondary|Number of Participants With no B-symptoms and With at Least One B-symptom Over Time|The number of participants with no B-symptoms (no night sweat, no weight loss, no fever and no extreme fatigue) and the number of participants with at least one of the B-symptoms are summarized by assessment time. The presence of the B-symptoms was assessed at Baseline, Day 1 of each treatment cycle and follow-up (FU). Baseline was the last pre-dose assessment performed at C1 D1.|Baseline, C2-D29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9-D225, FU 1-PDFU 1, FU 85-PDFU 85, and FU 169-PDFU 169|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Participants|||Number
2634925|NCT01808248|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
2634862|NCT01808326|Secondary|Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|ECOG PS is a scale to assess disease progression, extent to which disease affects the daily living abilities and determines appropriate treatment and prognosis. It is scored on a scale of 0 to 5 as, 0 (fully active), 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2 (ambulatory and capable of all self cares but unable to carry out any work activities, Up and about > 50% of waking hours), 3 (capable of only limited self cares, confined to bed or chair > 50% of waking hours), 4 (completely disabled, cannot carry on any self cares, totally confined to bed or chair), 5 (death). Improvement is defined as decrease from baseline by at least one step on the ECOG performance status scale (yes/no). Baseline was last pre-dose assessment performed on Cycle 1 Day 1(C1 D1). When C1 D1 was missing, the last assessment performed prior to pre-dose C1 D1 was used. It was performed on Day 1 of each cycle and follow-up (FU).|Baseline, Cycle (C) 2-Day (D) 29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9-D225, FU 1- PDFU 1, FU 85-PDFU 85, and FU 169-PDFU 169|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Participants|||Number
2634863|NCT01808326|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy|Time to next CLL therapy is defined as the time from start of treatment until the first administration of the next CLL treatment other than chlorambucil administrations scheduled in this study. Time to next CLL therapy was restricted to the subgroup of the population who receive a next CLL therapy after experiencing disease progression.|From the start of treatment until the first administration of the next CLL treatment (up to Week 61.1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Weeks||95% Confidence Interval|Median
2634864|NCT01808326|Secondary|Duration of Response, as Assessed by the IRC|Duration of response is defined as the time from the initial response (CR or PR) until progression or death. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From the initial response (CR/PR) until disease progression or death (up to Week 61.1)|All Subjects Population|||Weeks||95% Confidence Interval|Median
2634865|NCT01808326|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as time from the start of treatment until the first response (CR/PR). Time to Response analyses was restricted to the subgroup of the population who experienced an overall response (CR/ nPR/CRi/PR) during the study. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From the start of treatment until the first response (CR/PR) (up to Week 61.1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Weeks||95% Confidence Interval|Median
2634866|NCT01808326|Secondary|Overall Survival (OS)|Overall survival is defined as time from the start of treatment until death due to any cause. Participants who had not died were censored at the date of last contact.|From the start of treatment until death (up to Week 61.1)|All Subjects Population|||Weeks||95% Confidence Interval|Median
2634867|NCT01808326|Secondary|Progression Free Survival (PFS), as Assessed by the Investigator and the IRC|Progression-free survival (PFS) is defined as the time from the start of treatment of investigational product until the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlargerd lymph nodes (>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukaemia. Par. who were alive and had not progressed at the time of analysis or if a progression event or death occurred after extensive lost-to-follow-up time or if new anti-cancer therapy was started were censored at the date of the last visit with adequate assessment.|From the start of treatment until disease progression or death (up to Week 61.1)|All Subjects Population|||Weeks||95% Confidence Interval|Median
2634868|NCT01808326|Secondary|Number of Participants With the Best Overall Response (OR), as Assessed by the Investigator, IRC and IRC With CT|OR is defined as the number of participants achieving either a confirmed CR or PR. Assessment was completed by the Investigator, IRC, and IRC with CT. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly) > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL. nPR: persistent nodules BM.|From the start of treatment until disease progression or death (up to Week 61.1)|All Subjects Population|||Participants|||Number
2634869|NCT01808326|Primary|Number of Participants With a Best Response of Either Complete Remission (CR), Nodular Partial Remission (nPR), Complete Remission-incomplete (CRi) or Partial Remission (PR), as Assessed by the Investigator, IRC and IRC With CT|According to the criteria based on the 2008 revision of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) of the National Cancer Institute-Sponsored Working Group Guidelines (NCI-WG), participants with complete remission (CR), nodular partial remission (nPR), complete remission-incomplete (CRi) and partial remission (PR) were classified as responders, while stable disease (SD) and progressive disease (PD) were classified as non-responders. Participants with unknown or missing responses were considered as non-responders. Assessment was completed by the Investigator, Independent Review Committee (IRC), and IRC with Computed Tomography (CT).|From the start of treatment until disease progression or death (up to Week 61.1)|All Subjects Population: all participants who received at least one dose of investigational product.|||Participants|||Number
2634870|NCT01808313|Secondary|Number of Participants With Urinalysis Data at Baseline and Week 24|Urine samples were collected for urinalysis at Baseline and Week 24. The Number of participants with urinalysis to negative and positives (trace, +, ++ and +++) data at Baseline and Week 24 are summarized for urine bilirubin (UBIL), urine glucose (UGLU), urine ketones (UKET), urine nitrite (UNIT), urine protein (UM) and urine urobilinogen (UUBIL) were performed with dipstick method. Other urinalysis parameters included urine pH (UpH), urine specific gravity (USG). The Baseline value is defined as the last pre-treatment value observed.|Baseline and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Participants|||Number
2634871|NCT01808313|Secondary|Change From Baseline in Calcium, Cholesterol, Chloride, Glucose, Potassium, Magnesium, Sodium, Inorganic Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of calcium, cholesterol, chloride, glucose, potassium, magnesium, sodium, inorganic phosphorus, triglycerides and urea/Bun at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the calcium, cholesterol, chloride, glucose, potassium, magnesium, sodium, inorganic phosphorus, triglycerides and urea/BUN values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Millimoles per liter||Standard Deviation|Mean
2634872|NCT01808313|Secondary|Mean Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of direct bilirubin, total bilirubin, creatinine and uric acid at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the direct bilirubin, total bilirubin, creatinine and uric acid values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Micromoles per liter||Standard Deviation|Mean
2634873|NCT01808313|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of alkaline phosphatase (ALP), alanine amino transferase (ALT), aspartate amino transferase (AST), creatine kinase (CK), gamma glutamyl transferase (GGT) and lactate dehydrogenase (LDH) at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the ALP, ALT, AST, CK, GGT and LDH values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||International units per liter||Standard Deviation|Mean
2634874|NCT01808313|Secondary|Change From Baseline in Albumin, Globulin and Total Protein at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of albumin, globulin and total protein at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the albumin, globulin and total protein values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Grams per liter||Standard Deviation|Mean
2634875|NCT01808313|Secondary|Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of RBC count at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the red blood cell count values were summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Trillion cells per liter||Standard Deviation|Mean
2634949|NCT01808209|Primary|Comfort|Participant rating for comfort. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||units on a scale||Standard Deviation|Mean
2634877|NCT01808313|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of mean corpuscle hemoglobin at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the hemoglobin values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Picogram||Standard Deviation|Mean
2634878|NCT01808313|Secondary|Change From Baseline in Hematocrit at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of hematocrit at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the hematocrit values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is defined as the last Pre-treatment value observed. The unit of measure is defined as the proprtion of red blood cells in blood.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Proportion of 1||Standard Deviation|Mean
2634879|NCT01808313|Secondary|Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of hemoglobin at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the hemoglobin count values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Grams per liter||Standard Deviation|Mean
2634880|NCT01808313|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count at the Indicated Time Points up to Week 24|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and WBC count at the Baseline visit and Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in the basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and WBC count values were summarized for each post-Baseline assessment until Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last pre-treatment value observed.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Giga cells per liter||Standard Deviation|Mean
2634881|NCT01808313|Secondary|Number of Participants With Shift From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST) and Total Bilirubin (BILT) up to Week 24|Blood samples were collected for the measurement of ALT, ALP, AST and BILT at the Baseline visit and up to Week 24. Shift from Baseline (BL) was calculated as the individual maximum of post-BL value minus the BL value. The BL value is defined as the last pre-treatment value observed. Threshold values for the liver function test results, which were considered as potential values of clinical concern, were 3 times the upper limit of normal (ULN) for ALT, AST and ALP and 2 times the ULN for BILT. Maximum liver function abnormal values of post-BL are summarized.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Participants|||Number
2634882|NCT01808313|Secondary|Oral Temperature|Oral temperature was used to monitor vital signs and collected at the Screening visit.|Baseline|Safety Population|||Celsius||Full Range|Mean
2634883|NCT01808313|Secondary|Change From Baseline in Heart Rate at the Indicated Time Points up to Week 24|Vital sign monitoring included heart rate measurements at (pre-6MWT and post-6MWT at the Baseline visit, Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in heart rate was summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last non-missing value observed before treatment. At Baseline, Weeks 12 and 28, heart rate was recorded at the end of the 6MWT and at 1 minute (M), 2 M and 3 M, after completion of the 6MWT with the participants seated, and the time that heart rate recovered to the level of pre-6MWT.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Beats per minute||Standard Deviation|Mean
2634884|NCT01808313|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure at the Indicated Time Points up to Week 24|Blood pressure measurements (pre-6MWT and post-6MWT) were taken to monitor vital signs and included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the Baseline, Weeks 4, 8, 12, 16, 20 and 24. Change from Baseline in SBP and DBP were summarized for each post-Baseline assessment upto Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last non-missing observed value before treatment.|Baseline up to Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2634926|NCT01808248|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants discontinuing any study drug due to an adverse event was summarized.|Up to 12 weeks|Safety Analysis Set: participants enrolled and received at least 1 dose of study drug|||percentage of participants|||Number
2634885|NCT01808313|Secondary|Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QT Interval Corrected Bazett's Formula (QTcB) Values at Weeks 12 and 24|The ECG parameters, PR interval, QRS duration, uncorrected QT interval, QTcB were measured at Baseline, Weeks 12 and 24. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment up to Week 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last non-missing observed value before treatment.|Baseline, Week 12 and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Milliseconds||Standard Deviation|Mean
2634886|NCT01808313|Secondary|Change From Baseline in Electrocardiogram (ECG) Heart Rate Values at Weeks 12 and 24|Heart rate was measured in order to monitor vital signs by the 12-lead ECG at Baseline, Weeks 12 and 24. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment at Weeks 12 and 24. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. The Baseline value is defined as the last non-missing observed value before treatment.|Baseline, Week 12 and Week 24|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Beats per minute||Standard Deviation|Mean
2634887|NCT01808313|Secondary|Number of Participants With Physical Examination Findings|Complete physical examinations of each participant by the investigator were performed at the Screening Visit, Week 12 and Week 24 Visit/Early withdrawal visits. The physical examination included an examination of the following: general appearance, skin, head, ears, eyes, nose, throat, neck, thyroid, lymph nodes, cardiovascular system, respiratory system, abdomen, musculoskeletal system, neurological system and height. Physical examination summary results were not collected therefore there is no data to present for this outcome measure.|Baseline, Week 12 and Week 24|Safety Population|||Participants|||Number
2634888|NCT01808313|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events and Adverse Events Leading to Discontinuation|An adverse event (AE) is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, or important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|From the start of study treatment up to Week 24|Safety Population|||Participants|||Number
2634889|NCT01808313|Secondary|Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH) up to Week 24, Assessed as the First Occurrence of a Particular Event|Time to clinical worsening is defined as the time from Baseline to the first occurrence of death, lung transplantation, hospitalization for PAH treatment, atrial septostomy, or Investigational product (IP) discontinuation (discon) due to change to other PAH treatment. Time to clinical worsening was measured as the number of participants who experienced these events during 12 and 24 Weeks.|Baseline up to Week 24|Safety Population: This population comprised of all participants who received at least one dose of study medication.|||Participants|||Number
2634890|NCT01808313|Secondary|Change From Baseline in the N-Terminal Pro-B-Type Natriuretic Peptide at Weeks 12 and 24|N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) is a surrogate maker of heart failure and was measured by a central laboratory. Mean change from Baseline at Weeks 12 and 24 were calculated as the Weeks 12 and 24 values minus the Baseline values.Observed data was analyzed (no imputation technique was performed for missing data). Log transformed mean change from Baseline at Weeks 12 and 24 data are summarized.|Baseline, Week 12 and Week 24|ITT Population. Only those participants available at the specified time points were analyzed (represented by number of participants [n]=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflect everyone in the ITT Population.|||log(ng/L)||Standard Deviation|Mean
2634891|NCT01808313|Secondary|Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 12 and 24|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum). Change from Baseline was calculated as the Week 12 and 24 values minus the Baseline values. The BDI indicates the degree of exertion, breathlessness, fatigue, or difficulty breathing after completion of the 6MWT. The lower values, 0 as the lowest, indicates no exertion, fatigue, or breathlessness felt, and 10 would be the maximum amount of exertion felt as assessed by each participant. The last observation carried forward method was used to impute missing values.|Baseline, Week 12 and Week 24|ITT Population.|||scores on a scale||Standard Deviation|Mean
2634892|NCT01808313|Secondary|Number of Participants With a Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 12 and 24|The WHO FC was determined by the investigator as follows: Class I- Participants with pulmonary hypertension (PH) but without resulting limitation of physical activity, II- Participants with PH resulting in slight limitation of physical activity, III- Participants with PH resulting in marked limitation of physical activity, IV- Participants with PH with inability to carry out any physical activity without symptoms. Changes from Baseline in functional class were summarized at Weeks 12 and 24. The number of participants improving by 2 classes, improving by 1 class, not changing, worsening by 1 class or worsening by 2 classes from Baseline at Weeks 12 and 24 were evaluated. The Baseline value was the last non-missing assessment value before treatment. Only participants with non-missing Baseline values and at least one non-missing post-Baseline value of the response variable were included. The last observation carried forward method was used to impute missing values.|Baseline, Week 12 and Week 24|ITT Population|||Participants|||Number
2634950|NCT01808209|Primary|Comfort|Participant rating of lens comfort. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable,100=extreme comfort / cannot feel them at all)|Baseline|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||units on a scale||Standard Deviation|Mean
2634894|NCT01808313|Primary|Change From Baseline in 6-minutes Walk Test (6MWT) at Week 12|The 6MWT measures the distance that a participant can walk in a period of 6 minutes. Change from Baseline was calculated as the Week 12 value minus the Baseline value. Baseline 6MWT comprised of an average of the last two consecutive measurements prior to dosing that varied by not greater than 10 percent (%). If only one measurement was available, that measurement was used as the Baseline value. The last observation carried forward method was used to impute missing values.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants who received at least one dose of study medication and had an efficacy assessment performed both at Baseline and after administration of the study medication|||Meters||Standard Deviation|Mean
2634895|NCT01808261|Secondary|Antibodies Against GSK249320, Assessed Using Electrochemi-luminescent Assay (ECL) Assay|Blood samples were collected and the presence of antibodies against GSK249320 was assessed using ECL assays. Positive result indicated presence of antibodies and negative result indicated absence of antibodies. Confirmed samples with presence of antibodies were further characterized for neutralizing activity as binding antibody (BAb) and neutralising antibody (NAb) by a neutralization assay.By-visit sample sizes vary due to missing data or early termination of the study.|Day 1, Day 30, Day 180, EW visit and Follow-up visit|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2634896|NCT01808261|Secondary|Volume of Distribution (V1 and V2) and Volume at Steady State (Vss) for GSK249320|Blood samples were collected for determination of plasma concentrations of GSK249320. V1, V2 and Vss were derived from the plasma concentration-time data. Analysis was performed for PK Population that comprised of all participants in the Safety Population who had at least one PK sample with a concentration above the non-quantifiable limit. Only participants in the GSK249320 15 mg/kg group were analyzed.|Up to Day 180|PK Population|||milliliters/kilogram||Geometric Coefficient of Variation|Geometric Mean
2634897|NCT01808261|Secondary|Clearance (CL) for GSK249320|Blood samples were collected for determination of plasma concentrations of GSK249320. CL was derived from the plasma concentration-time data. Analysis was performed for PK Population that comprised of all participants in the Safety Population who had at least one PK sample with a concentration above the non-quantifiable limit. Only participants in the GSK249320 15 mg/kg group were analyzed.|Up to Day 180|PK Population.|||Milligrams/kilograms/hour||Geometric Coefficient of Variation|Geometric Mean
2634898|NCT01808261|Secondary|Area Under the Concentration-time Curve From 0 to 5 Days [AUC(0-5d)] and Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC(0-inf)] for GSK249320|Blood samples were collected for determination of plasma concentrations of GSK249320. AUC (0-5d) and AUC (0-inf) were derived from the plasma concentration-time data. AUC(0-5d) is the model predicted AUC over the planned TAU of 5 days. Only participants in the GSK249320 15 mg/kg group were analyzed.|Pre-dose and post-dose up to Day 180|PK Population.|||Milligrams/milliliter*hour||Geometric Coefficient of Variation|Geometric Mean
2634899|NCT01808261|Secondary|PK as Measured by Plasma Decay Half-life (t1/2) GSK249320|Blood samples were collected for determination of plasma concentrations of GSK249320. Terminal phase half-life was derived from the plasma concentration-time data. Only participants in the GSK249320 15 mg/kg group were analyzed.|Up to Day 180|PK Population.|||Days||Full Range|Median
2634900|NCT01808261|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) GSK249320|Tmax is the time of the occurrence of Cmax. The Cmax is defined as the maximum observed concentration of GSK249320 obtained at the end of infusion post dose on day 6. Due to early termination of the study data for Tmax was not collected.|Pre-dose and post-dose up to Day 180|PK population. Due to early termination of the study, data for Tmax was not collected||||||
2634901|NCT01808261|Secondary|Maximum Observed Plasma Concentration (Cmax) for GSK249320|Cmax is the maximum observed concentration of GSK249320 obtained at the end of infusion post dose on Day 6. Due to early termination of the study, this data was not collected.|Pre-dose and post-dose up to Day 180|The Pharmacokinetics (PK) population consisted of all participants in the Safety population who have at least one PK sample with a concentration above the non-quantifiable limit. Data not collected due to early termination of study.||||||
2634902|NCT01808261|Secondary|Number of Participants With Suicidal Ideation Via Columbia Suicide Severity Rating Scale (CSSRS)|C-SSRS is a clinician-rated scale that evaluates severity and change of suicidality by integrating both suicidality behavior and ideation. For Suicidal Ideation (SI), participants were scored non-suicidal:0, wish to be dead:1, non-specific active suicidal thoughts:2, active suicidal ideation with associated thoughts of methods without intent:3, active suicidal ideation with some intent to act on suicidal thoughts without clear plan:4, active suicidal ideation with plan and intent:5 (most severe). SI intensity total score was the sum of suicidal ideation severity rating scores for frequency, duration, controllability, deterrents, and reasons for ideation. For each item, each participant got an intensity score from 0(none) to 5(worst). Therefore, the suicidal ideation intensity total score range from 0 to 25, with a score of 0 given for no suicidal ideation.|Da y 1, Da y 6, Day 30, Day 60, Day 90 and Day 180|Safety Population. Number of participants with at least one on-treatment C-SSRS assessment were included.|||Participants|||Count of Participants
2634903|NCT01808261|Secondary|Change From BL in NIHSS Total Score|The NIHSS is a 15 item, standardized, disease-specific, deficit scale which measures neurological impairment (level of consciousness, eye movements, visual fields, facial symmetry, motor strength (arm and leg), coordination, sensation, language (aphasia and dysarthria), and neglect) and is used to quantify participant status by measuring the severity of the stroke as assessed by NIHSS certified study personnel. The total NIHSS score is calculated as the sum of responses to the 15 items. The total NIHSS score ranges from 0-42, with a higher score indicative of a more severe impairment. By-visit sample sizes vary due to missing data or early termination of the study. Change from BL was calculated as the individual post-Baseline value minus the BL value. BL was defined as the value at Day 1.|BL (Day 1), Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2634904|NCT01808261|Secondary|Change From Baseline in Hematology- Hematocrit|Hematocrit was measured at Baseline, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value.By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2634905|NCT01808261|Secondary|Change From BL in Hematology- Hemoglobin|Hemoglobin was measured at BL Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. . By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Grams per liter||Standard Deviation|Mean
2634906|NCT01808261|Secondary|Change From BL in Eosinophils (EOS), Lymphocytes (LYM), Total Absolute Neutrophil Count (ANC), Platelet (PLT) Count, White Blood Cell (WBC) Count|EOS, LYM, Total ANC, PLT count and WBC count were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value.By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Giga (10^9 cells) per liter||Standard Deviation|Mean
2634907|NCT01808261|Secondary|Change From BL in Clinical Chemistry- Direct Bilirubin, Total Bilirubin, Creatinine|Direct bilirubin, total bilirubin and creatinine were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Micromoles per liter||Standard Deviation|Mean
2634908|NCT01808261|Secondary|Change From BL in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)|ALP, ALT and AST were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.|||International units per liter||Standard Deviation|Mean
2634909|NCT01808261|Secondary|Change From BL in Clinical Chemistry-urea/Blood Urea Nitrogen (BUN), Sodium (Na), Potassium (K), Glucose (Gluc), Chloride (Cl), Calcium (Ca)|Ca, Cl, Gluc, K, Na and BUN were measured at BL, Day 6, Day 30, Day 90 and Day 180. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Millimoles per liter||Standard Deviation|Mean
2634910|NCT01808261|Secondary|Change From BL in Clinical Chemistry- Albumin and Total Protein|ALB and TP were measured at BL, Day 6, Day 30, Day 90 and Day 180. Baseline was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30, Day 90 and Day 180|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Grams per liter||Standard Deviation|Mean
2634911|NCT01808261|Secondary|Change From BL in ECG Parameters|A single 12-lead ECG was obtained at each time point and the following ECG intervals were determined: PR, QRS, QT, RR and corrected QT (QTc), QT interval corrected by Bazett's formula (QTcB), QT interval corrected by Fridericia's formula (QTcF). BL for ECG parameters was the value of Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1), Day 6, Day 30 and EW visit|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Milliseconds||Standard Deviation|Mean
2634912|NCT01808261|Secondary|Change From BL in ECG Parameter-Heart Rate|A single 12-lead ECG was obtained at each time point that measured heart rate. BL was the value obtained on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1) Day 6, Day 30 and EW visit|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2634913|NCT01808261|Secondary|Change From BL in Vitals Signs-Heart Rate|Safety was measured by monitoring vital signs including heart rate. The BL for heart rate was the value of pre-dose assessment on Day 1. Change from BL was calculated as the individual post-BL value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study. BL was defined as Day 1.|Day 1, Day 6, Day 180 and EW visit|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2634914|NCT01808261|Secondary|Change From BL in Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Safety was measured by monitoring vital signs including blood pressure. The BL for DBP and SBP was the value of pre-dose assessment on Day 1. Change from BL was calculated as the individual post-Baseline value minus the BL value. By-visit sample sizes vary due to missing data or early termination of the study.|BL (Day 1) , Day 6, Day 180 and early withdrawal (EW) visit|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
2634915|NCT01808261|Secondary|Number of Participants With Events Common to Stroke|Events common to stroke were those events that commonly occurred after a stroke and are generally associated with the underlying stroke or the progression of stroke. These included joint or soft tissue pain, bladder incontinence, depression/mood disorder, urinary tract infection, dysphagia, bowel incontinence, dysarthia, confusion, spasticity, limb edema, aspiration pneumonia, hemorrhagic transformation (symptomatic or asymptomatic), pressure ulcers, progression of stroke, malnutrition, deep vein thrombosis, brain herniation, pulmonary embolism, seizures, and falls.|From Day 1 until early withdrawal, death, Month 6/Day 180|Safety Population.|||Participants|||Count of Participants
2634927|NCT01808248|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 15 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 2 or 3 HCV infection who were enrolled and received at least 1 dose of study drug|||percentage of participants|||Number
2665777|NCT01529385|Primary|Ankle Edema|The circumference of ankle was measured by a tape measure.|change from baseline after 4 weeks of sock usage||||cm||95% Confidence Interval|Mean
2634916|NCT01808261|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or all events of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment is exercised in other situations.|Up to 14 months|Safety population.|||Participants|||Count of Participants
2634917|NCT01808261|Secondary|Number of Falls Over Time|The number of participants who experienced 1, 2, 3 or >=4 falls between BL to Day 90 and BL to Day 180 is summarized. By-visit sample sizes vary due to missing data or early termination of the study. The participants who experienced atleast one-fall were reported|BL (Day 1), Day 90 and Day 180|Safety Population.|||Participants|||Count of Participants
2634918|NCT01808261|Secondary|Number of Participants Experiencing Falls|The number of participants who experienced at least one fall between BL to Day 90 and BL to Day 180 is summarized.|BL (Day 1) Day 90 and Day 180|Safety population is defined as participants who had received at least one infusion of investigational product.|||Participants|||Count of Participants
2634919|NCT01808261|Secondary|Change From BL in Dexterity as Measured by Box and Blocks Test|Dexterity is ability of person to use hands skillfully in performing a task. Box and Blocks test is an objective, gross manual dexterity test in individuals with upper limb impairments. Participants were asked to move small wooden blocks from one side of a partitioned box to other. The score was determined by number of blocks transferred within a 60 second time period. Both affected and unaffected arms were tested, starting with the unaffected arm. Change from BL was calculated as the individual post- BL value minus BL value. A higher number of displaced blocks indicated a better gross dexterity and a low number of displaced blocks indicated poor gross dexterity. It was analyzed using fixed effects for treatment, visit, treatment by visit interaction, sex, age, Baseline National Institute of Health stroke scale (NIHSS) total score, BL number of blocks transferred by the affected and unaffected arms, country and presence of concomitant medications that potentially impact recovery.|BL (Day 1), Month 1/Day 30, Month 2/Day 60, Month 3/Day 90 and Month 6/Day 180|PP Population.|||Number of blocks||Standard Error|Least Squares Mean
2634920|NCT01808261|Secondary|Number of Participants With Indicated Transition From One Gait Velocity Category to Another Category at the Indicated Time Points|Participants were categorized at each visit into the following gait velocity categories: 0 m/s, >0 to <0.4 m/s, >=0.4 m/s to 0.8 m/s and >0.8m/s. A distinction was made between participants who are too incapacitated to walk (i.e., gait velocity = 0m/s) and participants for whom the gait velocity assessment was not performed due to another reason (i.e., truly missing data). Participants were asked to walk at their usual or normal pace and using their normal assistive devices. Two trials of gait velocity were conducted at each time point. The number of participants transitioning from one gait velocity category to another category was assessed at each post-Baseline visit and was presented in terms of the following transition categories: worsened, no change, improved 1 level, improved 2 levels and improved 3 levels. By-visit sample sizes vary due to missing data or early termination of the study, missing data was not imputed.|BL (Day 1), Month 1/Day 30, Month 2/Day 60, Month 3/Day 90 and Month 6/Day 180.|PP Population consisted of all participants who were included in the ITT population and did not violate protocol with regards to inclusion/exclusion criteria, unblinding, investigational product administration and gait velocity assessments. Only participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2634921|NCT01808261|Secondary|Mean Change From BL to Month 6/ Day 180 in Gait Velocity|Gait is the way or manner in which a person walks. Gait velocity (walking speed) is an objective, quantitative measure of lower extremity motor recovery in individuals who have had a stroke. Participants were asked to walk at their usual pace over a level, indoor 10 m distance and were allowed to use their normal assistive devices. The time (s) taken by the participants to travel the 10 m distance was recorded. Gait velocity (m/s) as assessed by study personnel was derived as: 10 divided by time to walk 10 m. Two trials of gait velocity were conducted at each time point. Change from BL was calculated as the mean Month 3/Day 90 value minus the mean BL value. BL was defined as Day 1. The measure type displayed are posterior means.|BL (Day 1) and Month 6/Day 180|ITT Population.|||m/s||Standard Deviation|Mean
2634922|NCT01808261|Primary|Mean Change From Baseline (BL) to Month 3/ Day 90 in Gait Velocity|Gait is the way or manner in which a person walks. Gait velocity (walking speed) is an objective, quantitative measure of lower extremity motor recovery in individuals who have had a stroke. Participants were asked to walk at their usual pace over a level, indoor 10 meter (m) distance and were allowed to use their normal assistive devices. The time (seconds[s]) taken by the participants to travel the 10 m distance was recorded. Gait velocity (m/s) as assessed by study personnel was derived as: 10 divided by time to walk 10 m. Two trials of gait velocity were conducted at each time point. Change from BL was calculated as the mean Month 3/Day 90 value minus the mean BL value. BL was defined as Day 1. The measure type displayed are posterior means.|BL (Day 1) and Month 3/Day 90|Intent-To-Treat (ITT) population comprised of participants who received at least 1 infusion of investigational product and had at least 1 post-Baseline efficacy assessment.|||m/s||Standard Deviation|Mean
2634923|NCT01808248|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2634924|NCT01808248|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as:~Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment"|Up to 12 weeks|Full Analysis Set|||percentage of participants|||Number
2665778|NCT01529385|Primary|Calf Edema|The circumference of calf was measured by a tape measure.|change from baseline after 4 weeks of sock usage||||cm||95% Confidence Interval|Mean
2634928|NCT01808222|Primary|The Presence of Cancer Tissue Outside of the Prostate Bed|"Participants had a fluciclovine PET-CT scan and a multiparametric magnetic imaging (mpMR) scan. The scans were read by experts (two for the PET-CT scans and two more for the mpMR scans) and the accuracy of each imaging technique was assessed by comparing the interpretations of the imaging to biopsy results. The degree of confidence of interpretation of each reader was recorded on a 5-point Likert scale where:~= definitely benign~= probably benign~= equivocal~= probably malignant~= definitely malignant For this analysis, scores of 4 or 5 were considered positive and scores of 1-3 were considered negative for malignant prostate disease."|Up to 43 months|The population assessed in this analysis includes participants with sufficient proof for the absence of presences of prostate disease (18 out of 24 participants who received both scans).|||Participants|||Count of Participants
2634929|NCT01808222|Primary|The Presence of Cancer Tissue Inside of the Prostate Bed|"Participants had a fluciclovine PET-CT scan and a multiparametric magnetic imaging (mpMR) scan. The scans were read by experts (two for the PET-CT scans and two more for the mpMR scans) and the accuracy of each imaging technique was assessed by comparing the interpretations of the imaging to biopsy results. The degree of confidence of interpretation of each reader was recorded on a 5-point Likert scale where:~= definitely benign~= probably benign~= equivocal~= probably malignant~= definitely malignant For this analysis, scores of 4 or 5 were considered positive and scores of 1-3 were considered negative for malignant prostate disease."|Up to 43 months|The population assessed in this analysis includes participants with sufficient proof for the absence of presences of prostate disease (22 out of 24 participants who received both scans). The remaining two had no biopsy or had insufficient follow-up information to reach a consensus about disease status.|||Participants|||Count of Participants
2634930|NCT01808209|Primary|Wettability|Participant rating for surface wettability. Collected at 1 week. Tear film analysis in seconds.|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||seconds|Participants|Standard Deviation|Mean
2634931|NCT01808209|Secondary|Conjunctival Staining|Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||units on a scale|Participants|Standard Deviation|Mean
2634932|NCT01808209|Secondary|Corneal Staining|Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )|1 Week||||units on a scale|Participants|Standard Deviation|Mean
2634933|NCT01808209|Secondary|Corneal Staining|Assessment of ocular health. Collected at baseline after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )|Baseline|Prior to randomization|||units on a scale|Participants|Standard Deviation|Mean
2634934|NCT01808209|Secondary|Conjunctival Redness|Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of conjunctival redness.|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||percentage of redness|Participants|Standard Deviation|Mean
2634935|NCT01808209|Secondary|Conjunctival Redness|Assessment of ocular health. Collected at baseline after removal of lenses. Percentage of conjunctival redness.|Baseline||||percentage of redness|Participants|Standard Deviation|Mean
2634936|NCT01808209|Secondary|Blood Vessel Coverage|Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of blood vessel coverage.|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||percentage of blood vessel coverage|Participants|Standard Deviation|Mean
2634937|NCT01808209|Primary|Visual Acuity logMAR|Assessment of Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at 1 week for study lenses. logMAR|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||logMAR||Standard Deviation|Mean
2634938|NCT01808209|Primary|Visual Acuity logMAR|Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at dispense for study lenses. logMAR.|Dispense|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||logMAR||Standard Deviation|Mean
2634939|NCT01808209|Primary|Visual Acuity logMAR|Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at baseline for habitual lens. logMAR.|Baseline||||logMAR||Standard Deviation|Mean
2634940|NCT01808209|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at 1 week for study lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).|1 Week||||units on a scale||Standard Deviation|Mean
2634941|NCT01808209|Primary|Overall Satisfaction|Participant rating for overall satisfaction. Collected at baseline for habitual lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).|Baseline||||units on a scale||Standard Deviation|Mean
2634942|NCT01808209|Primary|Eye Whiteness|Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||units on a scale||Standard Deviation|Mean
2634943|NCT01808209|Primary|Eye Whiteness|Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).|Baseline||||units on a scale||Standard Deviation|Mean
2634944|NCT01808209|Primary|Vision Quality|Participant rating of vision quality. Collected at 1 week. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||units on a scale||Standard Deviation|Mean
2634945|NCT01808209|Primary|Vision Quality|Participant rating of vision quality. Collected at baseline for habitual lens. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)|Baseline||||units on a scale||Standard Deviation|Mean
2634946|NCT01808209|Primary|Dryness|Participant rating for dryness. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||units on a scale||Standard Deviation|Mean
2634947|NCT01808209|Secondary|Blood Vessel Coverage|Assessment of ocular health. Collected at baseline after removal of lenses. Percent of blood vessel coverage.|Baseline|Prior to randomization|||percentage of blood vessel coverage|Participants|Standard Deviation|Mean
2639605|NCT01763866|Secondary|Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2634951|NCT01808209|Primary|Handling|Participant rating for lens handling. Collected at 1 week. (Insertion: 0-100, 0= could not get it in and 100= went in without a problem. Removal: 0= could not get it out and 100= came out without a problem. Blister: 0=impossible and 100=came out extremely easily).|1 Week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||units on a scale||Standard Deviation|Mean
2634952|NCT01808209|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at 1 week wear for each lens.(The hours of average comfortable wearing time and average daily wearing time.)|1 week|All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.|||hours||Standard Deviation|Mean
2634953|NCT01808209|Primary|Daily and Comfortable Wearing Time|Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses.(The hours of average comfortable wearing time and average daily wearing time.)|Baseline||||hours||Standard Deviation|Mean
2634954|NCT01808144|Secondary|Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus|Percentage of participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus During the Core and Extension Studies at Extension Month 12 (Observed Cases)|Up to approximatley 2.5 years (at Extension Month 12)|ITT Population Number of Participants Analyzed for this Outcome Measure reflects the number of participants who completed through Month 12.|||Percentage of participants|||Number
2634955|NCT01808144|Primary|Percentage of Participants With an sUA Level That is < 5.0 mg/dL|Percentage of participants in Study 307 With sUA < 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases|Up to approximately 2.5 years (at Extension Month 12)|Number of Participants Analyzed for this Outcome Measure reflects the number of participants who completed Extension Month 12.|||Percentage of participants|||Number
2634956|NCT01808118|Secondary|Number of Participants Reaching Partial Flare Definition by Week 68|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A partial flare was defined as having any 2 consecutive study visits with ASDAS ≥ 1.300 but <2.100.|From Week 28 through 68|Modified Intent-to-treat population: all participants who were randomized into double-blind Period 2 and received at least 1 dose of double-blind study medication; participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
2634957|NCT01808118|Secondary|Number of Participants Reaching Flare Definition by Week 68|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A flare was defined as having any 2 consecutive study visits with ASDAS ≥ 2.100.|From Week 28 through 68|Modified Intent-to-treat population: all participants who were randomized into double-blind Period 2 and received at least 1 dose of double-blind study medication; participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
2634958|NCT01808118|Secondary|Time to Partial Flare at Week 68|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A partial flare was defined as having any 2 consecutive study visits with ASDAS ≥ 1.300 but <2.100.|From Week 28 through 68|Modified Intent-to-treat population: all participants who were randomized into double-blind Period 2 and received at least 1 dose of double-blind study medication; participants with missing data were treated as missing.|||weeks||95% Confidence Interval|Median
2634959|NCT01808118|Secondary|Time to Flare at Week 68|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A flare was defined as having any 2 consecutive study visits with ASDAS ≥ 2.100.|From Week 28 through 68|Modified Intent-to-treat population: all participants who were randomized into double-blind Period 2 and received at least 1 dose of double-blind study medication; participants with missing data were treated as missing.|||weeks||95% Confidence Interval|Median
2635084|NCT01807624|Secondary|Decrease in Pulse Rate > 20 Bpm on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||participants|||Number
2634960|NCT01808118|Secondary|Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) at Weeks 28 and 68|Health Assessment Questionnaire modified for spondyloarthropathies (HAQ-S) is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (very severe, high-dependency disability). Negative mean changes from baseline in the overall score indicate improvement.|Baseline, Weeks 28 and 68|Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.|||units on a scale||Standard Deviation|Mean
2634961|NCT01808118|Secondary|Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Weeks 28 and 68|The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity. BASDAI50 is a 50% improvement from baseline in BASDAI score.|Baseline, Weeks 28 and 68|Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
2634962|NCT01808118|Secondary|Number of Participants Achieving ASAS Partial Remission at Weeks 28 and 68|"Assessment in SpondyloArthritis International Society (ASAS) partial remission is defined as an absolute score of < 2 units on a 0 to 10 scale for each of the four following domains:~Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline, Weeks 28 and 68|Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
2634963|NCT01808118|Secondary|Number of Participants Achieving an ASAS 5/6 Response at Weeks 28 and 68|"An Assessment of Spondyloarthritis International Society (ASAS) 5/6 response is a 20% improvement in 5 out of the following 6 domains:~Patient's Global Assessment of disease activity, on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which assesses participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation: the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none) to 10 (very severe/2 hrs or more duration);~Spinal mobility: the lateral lumbar flexion score of the Bath AS Metrology Index (BASMI) on a scale from 0 (best mobility) to 10 (worst mobility);~High-sensitivity C-reactive protein level (lower levels = less inflammation)."|Baseline, Weeks 28 and 68|Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
2634964|NCT01808118|Secondary|Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Weeks 28 and 68|"ASAS40 response was defined as improvement of ≥ 40% relative to baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline, Weeks 28 and 68|Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
2634971|NCT01808118|Secondary|Number of Participants Achieving ASAS Partial Remission at 12 Weeks After Initiation of Rescue Therapy|"Assessment in SpondyloArthritis International Society (ASAS) partial remission is defined as an absolute score of < 2 units on a 0 to 10 scale for each of the four following domains:~Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Rescue Therapy Week 12|Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period|||Participants|||Count of Participants
2634965|NCT01808118|Secondary|Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response at Weeks 28 and 68|"ASAS20 response was defined as improvement of ≥ 20% relative to baseline and absolute improvement of ≥ 1 unit (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 unit) in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline, Weeks 28 and 68|Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
2634966|NCT01808118|Secondary|Number of Participants Achieving ASDAS Clinically Important Improvement at Weeks 28 and 68|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Clinically Important Improvement is defined as a change from baseline ≤ -1.100.|Baseline, Weeks 28 and 68|Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
2634967|NCT01808118|Secondary|Number of Participants Achieving ASDAS Major Improvement at Weeks 28 and 68|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Major Improvement is defined as a change from baseline ≤ -2.000.|Baseline, Weeks 28 and 68|Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
2634968|NCT01808118|Secondary|Number of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease at Weeks 28 and 68|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Inactive Disease is defined as a score of <1.300.|Weeks 28 and 68|Period 1 (all enrolled participants who received at least 1 dose of adalimumab); Period 2 (mITT: all randomized participants who received at least 1 dose of double-blind study medication); participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
2634969|NCT01808118|Secondary|Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) at 12 Weeks After Initiation of Rescue Therapy|Health Assessment Questionnaire modified for spondyloarthropathies (HAQ-S) is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (very severe, high-dependency disability). Negative mean changes from baseline in the overall score indicate improvement.|Baseline and Rescue Therapy Week 12|Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period|||units on a scale||Standard Deviation|Mean
2634970|NCT01808118|Secondary|Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at 12 Weeks After Initiation of Rescue Therapy|The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity. BASDAI50 is a 50% improvement from baseline in BASDAI score.|Baseline and Rescue Therapy Week 12|Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period|||Participants|||Count of Participants
2635708|NCT01800162|Secondary|Treatment Complications and Adverse Events|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|42 days after the last dose of study medication|||||||
2634972|NCT01808118|Secondary|Number of Participants Achieving an ASAS 5/6 Response at 12 Weeks After Initiation of Rescue Therapy|"An Assessment of Spondyloarthritis International Society (ASAS) 5/6 response is a 20% improvement in 5 out of the following 6 domains:~Patient's Global Assessment of disease activity, on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which assesses participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation: the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none) to 10 (very severe/2 hrs or more duration);~Spinal mobility: the lateral lumbar flexion score of the Bath AS Metrology Index (BASMI) on a scale from 0 (best mobility) to 10 (worst mobility);~High-sensitivity C-reactive protein level (lower levels = less inflammation)."|Baseline and Rescue Therapy Week 12|Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period|||Participants|||Count of Participants
2634973|NCT01808118|Secondary|Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at 12 Weeks After Initiation of Rescue Therapy|"ASAS40 response was defined as improvement of ≥ 40% relative to baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Rescue Therapy Week 12|Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period|||Participants|||Count of Participants
2634974|NCT01808118|Secondary|Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response at 12 Weeks After Initiation of Rescue Therapy|"ASAS20 response was defined as improvement of ≥ 20% relative to baseline and absolute improvement of ≥ 1 unit (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 unit) in the potential remaining domain:~Patient's Global Assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (none) to 10 (severe);~Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe);~Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible);~Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration)."|Baseline and Rescue Therapy Week 12|Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period|||Participants|||Count of Participants
2634975|NCT01808118|Secondary|Number of Participants Achieving ASDAS Clinically Important Improvement at 12 Weeks After Initiation of Rescue Therapy|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Clinically Important Improvement is defined as a change from baseline ≤ -1.100.|Baseline and Rescue Therapy Week 12|Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period|||Participants|||Count of Participants
2634976|NCT01808118|Secondary|Number of Participants Achieving ASDAS Major Improvement at 12 Weeks After Initiation of Rescue Therapy|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Major Improvement is defined as a change from baseline ≤ -2.000.|Baseline and Rescue Therapy Week 12|Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period|||Participants|||Count of Participants
2634977|NCT01808118|Secondary|Number of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease at 12 Weeks After Initiation of Rescue Therapy|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). ASDAS Inactive Disease is defined as a score of <1.300.|Rescue Therapy Week 12|Rescued Population: participants with available data who received open-label rescue treatment after the double-blind period|||Participants|||Count of Participants
2635085|NCT01807624|Secondary|Increase in Pulse Rate > 20 Bpm on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||participants|||Number
2668470|NCT01505764|Secondary|Food Diary Calorie Count|change between day 84 and baseline|day 84|cancer cachexia patients|||percentage change||Standard Deviation|Mean
2634978|NCT01808118|Primary|Number of Participants Who Did Not Experience a Flare During Period 2 by Week 68|The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A flare was defined as having any 2 consecutive study visits with ASDAS ≥ 2.100.|From Week 28 through 68|Modified Intent-to-treat population: all participants who were randomized into double-blind Period 2 and received at least 1 dose of double-blind study medication; participants with missing data were inputed as nonresponders.|||Participants|||Count of Participants
2634979|NCT01808092|Secondary|The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set|The number of patients discharged from hospital in the clinically evaluable at test-of-cure analysis set.|up to 25 days from randomization|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.|||participants|||Number
2634980|NCT01808092|Secondary|The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set|The number of patients discharged from hospital in the clinically modified intent-to-treat analysis set.|up to 25 days from randomization|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
2634981|NCT01808092|Secondary|The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set|The number of patients discharged from hospital in microbiologically modified intent-to-treat analysis set.|up to 25 days from randomization|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
2634982|NCT01808092|Secondary|The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28|The number of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set at day 28.|at Day 28 from randomization|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.|||participants|||Number
2634983|NCT01808092|Secondary|The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28|The number of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at day 28.|at Day 28 from randomization|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
2634984|NCT01808092|Secondary|The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28|The number of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at day 28.|at Day 28 from randomization|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
2634985|NCT01808092|Secondary|The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set|The number of patients with death due to any cause (all-cause mortality) in the clinically evaluable at test-of-cure analysis set.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.|||participants|||Number
2634986|NCT01808092|Secondary|The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The number of patients with death due to any cause (all-cause mortality) in clinically modified intent-to-treat analysis set at test-of-cure visit.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
2634987|NCT01808092|Secondary|The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The number of patients with death due to any cause (all-cause mortality) in microbiologically modified intent-to-treat analysis set at test-of-cure visit.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
2635086|NCT01807624|Secondary|Decrease in DBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||participants|||Number
2635087|NCT01807624|Secondary|Increase in DBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||participants|||Number
2634988|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|Microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at TOC (pathogens in ≥5 patients)|||participants with favorable responses|||Number
2634989|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC (pathogens in ≥5 patients)|||participants with favorable responses|||Number
2634990|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC (pathogens in ≥5 patients)|||participants with favorable responses|||Number
2634991|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|Microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at EOT (pathogens in ≥5 patients)|||participants with favorable responses|||Number
2634992|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT (pathogens in ≥5 patients)|||participants with favorable responses|||Number
2634993|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT (pathogens in ≥5 patients)|||participants with favorable responses|||Number
2634994|NCT01808092|Secondary|Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at TOC|||participants|||Number
2635088|NCT01807624|Secondary|Decrease in SBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||participants|||Number
2668600|NCT01504867|Secondary|Number of Subjects With Mechanical Ventilation at Any Time During Hospitalization||approximately 7 days|Intention-to-Treat|||participants|||Number
2634995|NCT01808092|Secondary|Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC|||participants|||Number
2634996|NCT01808092|Secondary|Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at TOC|||participants|||Number
2634997|NCT01808092|Secondary|Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). Patients infected with ceftazidime-resistant Gram negative pathogens at EOT|||participants|||Number
2634998|NCT01808092|Secondary|Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT|||participants|||Number
2634999|NCT01808092|Secondary|Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. Patients infected with ceftazidime-resistant Gram negative pathogens at EOT|||participants|||Number
2635000|NCT01808092|Secondary|The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥5 patients)|||participants|||Number
2635001|NCT01808092|Secondary|The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc. (pathogens in ≥5 patients)|||participants|||Number
2635059|NCT01807923|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Week 24|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2635002|NCT01808092|Secondary|The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥5 patients)|||participants|||Number
2635003|NCT01808092|Secondary|The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥5 patients)|||participants|||Number
2635004|NCT01808092|Secondary|The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc. (pathogens in ≥5 patients)|||participants|||Number
2635005|NCT01808092|Secondary|The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥5 patients)|||participants|||Number
2635006|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥10 patients)|||participants with favorable responses|||Number
2635007|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. (pathogens in ≥10 patients)|||participants with favorable responses|||Number
2635008|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥10 patients)|||participants with favorable responses|||Number
2635009|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem). (pathogens in ≥10 patients)|||participants with favorable responses|||Number
2636605|NCT01790178|Primary|Amount of Tissue Obtained|This data will be analyzed to determine if ultrasound guidance improves muscle yield (as measured by pathology determined volume and mass).|At time of biopsy||||grams||Standard Deviation|Mean
2635010|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents. (pathogens in ≥10 patients)|||participants with favorable responses|||Number
2635011|NCT01808092|Secondary|The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit|The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen. (pathogens in ≥10 patients)|||participants with favorable responses|||Number
2635012|NCT01808092|Secondary|The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).|||participants|||Number
2635013|NCT01808092|Secondary|The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).|||participants|||Number
2635014|NCT01808092|Secondary|The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.|||participants|||Number
2635015|NCT01808092|Secondary|The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.|||participants|||Number
2635016|NCT01808092|Secondary|The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
2635017|NCT01808092|Secondary|The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated. Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure."|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
2635060|NCT01807923|Secondary|Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||kilogram per square meter (kg/m^2)||Standard Error|Least Squares Mean
2635018|NCT01808092|Secondary|The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).|||participants|||Number
2635019|NCT01808092|Secondary|The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.|||participants|||Number
2635020|NCT01808092|Secondary|The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.|||participants|||Number
2635021|NCT01808092|Secondary|The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
2635022|NCT01808092|Secondary|The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set|The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment.|Patients were followed after the last IV dose but no later than 24 hours after the last IV dose.|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
2635023|NCT01808092|Secondary|The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiologically evaluable (ME) analysis sets defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture that is susceptible to both study agents (CAZ-AVI and meropenem).|||participants|||Number
2635024|NCT01808092|Secondary|The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The extended-ME (EME) analysis set defined as all patients in clinically evaluable (CE) analysis set with at least 1 etiologic pathogen from an adequate baseline culture regardless of susceptibility to study agents.|||participants|||Number
2635025|NCT01808092|Secondary|The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The microbiological modified intent-to-treat (mMITT) analysis set included all patients who met the minimum disease criteria and received any amount of study treatment, and had at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
2635026|NCT01808092|Primary|The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses)|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinically evaluable (CE) analysis set included all patients in the clinical modified intent-to-treat (cMITT) analysis set who met the stringent criteria for clinical evaluation described in the protocol regarding dosing, prior and concomitant medication, evaluation, etc.|||participants|||Number
2668601|NCT01504867|Secondary|Number of Participants With ARDS or Mortality Within 7 Days||within 7 days||||participants|||Number
2635027|NCT01808092|Primary|The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses)|The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.|At the test-of-cure (TOC) visit (Day 21 to 25)|The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.|||participants|||Number
2635028|NCT01808066|Other Pre-specified|Number of Participants Identified by Teachers as Attentive, Interested and Motivated Following Testing Via Post Test Interview|"Researchers will ask teachers for qualitative feedback once participants have completed game play about interest in using the game and any improvements to be made. Did they think the game was interactive. Would they use the game again? Do they think the students were able to maintain their interest?~Number of Participants identified as attentive, interested and motivated via pre interview"|Day 21||||Participants|||Count of Participants
2635029|NCT01808066|Other Pre-specified|Number of Participants Identified as Interested and Improved Quality of Life in Classroom Via Post Test Interview|After playing game for three weeks, researchers will interview participants about their interest in the game and changes in quality of life (no forms).|Day 21||||Participants|||Count of Participants
2635030|NCT01808066|Other Pre-specified|Number of Participants by Teachers Identified as Attentive, Interested and Motivated Via Pre Interview|Researchers will conduct interviews with teachers and collect all notes/journals recorded. Specific questions will be asked about their perception of their attention, interest and motivation to play the game. Example of questions included if they enjoyed playing the game, if they wanted to play the game and if they have trouble focusing during the game. Was it too long? Themes of the answers will be identified by researchers as a qualitative measure of interest.|Day 1||||Participants|||Count of Participants
2635031|NCT01808066|Secondary|Number of Participants Identified as Attentive, Interested and Motivated Via Pre Interview|Researchers will conduct interviews with players and collect all notes/journals recorded. Specific questions will be asked about their perception of their attention, interest and motivation to play the game. Example of questions included if they enjoyed playing the game, if they wanted to play the game and if they have trouble focusing during the game. Was it too long? Themes of the answers will be identified by researchers as a qualitative measure of interest.|Day 1|participants in a school who underwent the intervention for 3 weeks|||Participants|||Count of Participants
2635032|NCT01808066|Primary|Number of Participants With an Increase/Improvement in Focusing|Researchers will observe and record data during the first play session. Over the three weeks, teachers/support staff will be asked to observe players each day and record their observations as needed in a journal. These observations will measure their improvement in their ability to focus by assessing their engagement, time played, frequency of play, ability to complete a session and ability to start and finish a session. At the end of three weeks, researchers will attend the final play session and record observations in writing.|3 weeks||||participants|||Number
2635033|NCT01807949|Secondary|Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)|Ctrough, Ctrough,avg, C3-6h, and C3-6h,avg for lumacaftor, M28 lumacaftor (lumacaftor metabolite), ivacaftor, M1 ivacaftor (ivacaftor metabolite), and M6 ivacaftor (ivacaftor metabolite) were calculated. C3-6h,avg is average of individual 3 to 6 hours post-dose observed concentrations across Day 15, and Weeks 4 and 8 and Ctrough,avg is average of individual pre-dose observed concentrations across Weeks 4, 8, and 16. This outcome was not planned to be assessed in Placebo arm.|For C3-6h: 3 to 6 hours after morning dose on Day 1 and 15, Week 4 and 8; For C3-6h,avg 3 to 6 hours after morning dose on Day 15, Week 4 and 8; For Ctrough and Ctrough,avg: before morning dose on Week 4, 8, and 16|Pharmacokinetic (PK) population included all randomized participants who received at least one dose of study drug and had a PK assessment. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and “n” signifies participants evaluable for specified category for each arm, respectively.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2635034|NCT01807949|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or that was newly developed at or after the initial dosing of study drug to 28 days after the last dose of study drug is considered treatment-emergent.|up to Week 28|Safety Set (SS) included all randomized participants who received any amount of study drug. Participants were analyzed as per actual treatment received.|||participants|||Number
2635035|NCT01807949|Secondary|Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Scores at Week 24|The TSQM is a 14-item self-administered questionnaire which measures participants' experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed to a scale from 0 to 100, where higher scores indicate greater satisfaction.|Baseline, Week 24|"FAS. Here, n signifies participants who were evaluable for specified category for each arm, respectively."|||units on a scale||Standard Error|Least Squares Mean
2635036|NCT01807949|Secondary|Absolute Change From Baseline in EQ-5D-3L VAS Score at Week 24|The EQ-5D-3L VAS records the participant's self-rated health on a vertical, visual analogue scale where the best state a participant can imagine is marked 100 and the worst state a participant can imagine is marked 0, higher scores indicates a better health state.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2668602|NCT01504867|Secondary|Hospital Mortality||28 days|Intention-to-Treat|||participants|||Number
2635037|NCT01807949|Secondary|Absolute Change From Baseline in Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L) Index Score at Week 24|EQ-5D-3L: participant rated questionnaire to assess health-related quality of life. It consists of EQ-5D descriptive system and EQ-5D Visual Analog Scale (VAS). EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). The 5 dimensional 3-level systems are converted into a single index utility score. Values for theoretically possible health states are calculated using a regression model and weighted according to the social preferences of the Unites States (US) general population. For this population, the possible EQ-5D-3L index scores ranges from -0.11 (that is, 3 for all 5 dimensions) to 1.0 (that is, 1 for all 5 dimensions), where higher scores indicate a better health state.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2635038|NCT01807949|Secondary|Percentage of Participants With At Least 1 Pulmonary Exacerbation Event||through Week 24|FAS.|||percentage of participants|||Number
2635039|NCT01807949|Secondary|Time-to-First Pulmonary Exacerbation|Time to first pulmonary exacerbation was assessed using Cox Regression method. For participants who completed 24 weeks of treatment, participants without a pulmonary exacerbation before treatment completion were considered censored at the time of treatment completion or at the Week 24 Visit (whichever occurred last). For participants who prematurely discontinued study treatment, participants without a pulmonary exacerbation through the Week 24 Visit were considered censored at the time of the Week 24 Visit.|through Week 24|FAS.|||days||Full Range|Median
2635040|NCT01807949|Secondary|Absolute Change From Baseline in BMI-for-age Z-score at Week 24|Z-Score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is with range from -infinity to +infinity; 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. BMI-for-age z-score was calculated by using centers for disease control and prevention (CDC) growth charts for the pediatric population.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Only participants who were <20 years of age were analyzed.|||z-score||Standard Error|Least Squares Mean
2635041|NCT01807949|Secondary|Absolute Change From Baseline in Weight at Week 24||Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||kilograms (kg)||Standard Error|Least Squares Mean
2635042|NCT01807949|Secondary|Number of Pulmonary Exacerbation Events|The total number of days on study is equal to the Week 24 date or the last dose date (whichever occurred last) minus the first dose date plus 1. The total number of years (48 weeks) on study is equal to the number of days on study divided by 336. Pulmonary exacerbation events per year (48 weeks) are reported.|through Week 24|FAS.|||pulmonary exacerbation events per year|||Number
2635043|NCT01807949|Secondary|Percentage of Participants With Response Based on Percent Predicted FEV1|A participant was considered as a responder if the participant had >=5% increase from baseline in average percent predicted FEV1 at Week 16 and at Week 24 (relative change). FEV1 and percent predicted FEV1 are defined in OM 1. A participant with a missing average relative change from baseline in percent predicted FEV1 at Week 16 and at Week 24 was considered as a non-responder.|Week 16 and 24|FAS.|||percentage of participants|||Number
2635044|NCT01807949|Secondary|Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Week 24|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), the scaled score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2635045|NCT01807949|Secondary|Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||kilogram per square meter (kg/m^2)||Standard Error|Least Squares Mean
2635046|NCT01807949|Secondary|Relative Change From Baseline in Percent Predicted FEV1 at Week 24|Assessed as the average treatment effect at Week 16 and at Week 24. FEV1 and percent predicted FEV1 are defined in Outcome Measure (OM) 1.|Baseline, Week 16 and 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percent change||Standard Error|Least Squares Mean
2635047|NCT01807949|Primary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24|Absolute change from baseline at week 24 was assessed as the average treatment effect at Week 16 and at Week 24. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years.|Baseline, Week 16 and 24|Full Analysis Set (FAS) included all randomized participants who received any amount of study drug. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percent predicted of FEV1||Standard Error|Least Squares Mean
2635061|NCT01807923|Secondary|Relative Change From Baseline in Percent Predicted FEV1 at Week 24|Assessed as the average treatment effect at Week 16 and at Week 24. FEV1 and percent predicted FEV1 are defined in Outcome Measure (OM) 1.|Baseline, Week 16 and 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percent change||Standard Error|Least Squares Mean
2635089|NCT01807624|Secondary|Increase in SBP > 20 mmHg on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||participants|||Number
2635090|NCT01807624|Primary|AUC0-infinity of Oxymetazoline and PBBA||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||ng*h/mL||Standard Deviation|Mean
2635048|NCT01807923|Secondary|Pre-dose Concentration (Ctrough), Average Pre-dose Concentration (Ctrough,Avg), 3 to 6 Hours Post-dose Concentration (C3-6h), and Average 3 to 6 Hours Post-dose Concentration (C3-6h,Avg)|Ctrough, Ctrough, avg, C3-6h, and C3-6h, avg for lumacaftor, M28 lumacaftor (lumacaftor metabolite), ivacaftor, M1 ivacaftor (ivacaftor metabolite), and M6 ivacaftor (ivacaftor metabolite) were calculated. C3-6h,ave is average of individual 3 to 6 hours post-dose observed concentrations across Day 15, and Weeks 4 and 8 and Ctrough, ave is average of individual pre-dose observed concentrations across Weeks 4, 8, and 16. This outcome was not planned to be assessed in Placebo arm.|For C3-6h: 3 to 6 hours after morning dose on Day 1 and 15, Week 4 and 8; For C3-6h,avg 3 to 6 hours after morning dose on Day 15, Week 4 and 8; For Ctrough and Ctrough,avg: before morning dose on Week 4, 8, and 16|Pharmacokinetic (PK) population included all randomized participants who received at least one dose of study drug and had a PK assessment. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and “n” signifies participants evaluable for specified category for each arm, respectively.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2635049|NCT01807923|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Treatment-Emergent Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes serious as well as Nonserious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Any AE that increased in severity or that was newly developed at or after the initial dosing of study drug to 28 days after the last dose of study drug is considered treatment-emergent.|up to Week 28|Safety Set (SS) included all randomized participants who received any amount of study drug.|||participants|||Number
2635050|NCT01807923|Secondary|Absolute Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Domain Scores at Week 24|The TSQM is a 14-item self-administered questionnaire which measures participants' experiences with their medication on four dimensions: effectiveness, side effects, convenience and global satisfaction. For each dimension, responses are added and transformed to a scale from 0 to 100, where higher scores indicate greater satisfaction.|Baseline, Week 24|"FAS. Here, n signifies participants who were evaluable for specified category for each arm, respectively."|||units on a scale||Standard Error|Least Squares Mean
2635051|NCT01807923|Secondary|Absolute Change From Baseline in EQ-5D-3L VAS Score at Week 24|The EQ-5D-3L VAS records the participant's self-rated health on a vertical, visual analogue scale where the best state a participant can imagine is marked 100 and the worst state a participant can imagine is marked 0, higher scores indicates a better health state.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2635052|NCT01807923|Secondary|Absolute Change From Baseline in Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L) Index Score at Week 24|EQ-5D-3L: participant rated questionnaire to assess health-related quality of life. It consists of EQ-5D descriptive system and EQ-5D Visual Analog Scale (VAS). EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems (1), some problems (2), and extreme problems (3). The 5 dimensional 3-level systems are converted into a single index utility score. Values for theoretically possible health states are calculated using a regression model and weighted according to the social preferences of the Unites States (US) general population. For this population, the possible EQ-5D-3L index scores ranges from -0.11 (that is, 3 for all 5 dimensions) to 1.0 (that is, 1 for all 5 dimensions), where higher scores indicate a better health state.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2635053|NCT01807923|Secondary|Percentage of Participants With At Least 1 Pulmonary Exacerbation Event||through Week 24|FAS.|||percentage of participants|||Number
2635054|NCT01807923|Secondary|Time-to-First Pulmonary Exacerbation|Time to first pulmonary exacerbation was assessed using Cox Regression. For participants who completed 24 weeks of treatment, participants without a pulmonary exacerbation before treatment completion were considered censored at the time of treatment completion or at the Week 24 Visit (whichever occurred last). For participants who prematurely discontinued study treatment, participants without a pulmonary exacerbation through the Week 24 Visit were considered censored at the time of the Week 24 Visit.|through Week 24|FAS.|||days||Full Range|Median
2635055|NCT01807923|Secondary|Absolute Change From Baseline in BMI-for-age Z-score at Week 24|Z-Score is a statistical measure to evaluate how a single data point compares to a standard. It describes whether a mean was above or below the standard and how unusual the measurement is with range from -infinity to + infinity; 0: same mean, >0: a greater mean, and <0: a lesser mean than the standard. BMI-for-age z-score was calculated by using Centers for Disease Control and Prevention (CDC) growth charts for the pediatric population.|Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure. Only participants who were <20 years of age were analyzed.|||z-score||Standard Error|Least Squares Mean
2635056|NCT01807923|Secondary|Absolute Change From Baseline in Weight at Week 24||Baseline, Week 24|FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||kilograms (kg)||Standard Error|Least Squares Mean
2635057|NCT01807923|Secondary|Number of Pulmonary Exacerbation Events|The total number of days on study is equal to the Week 24 date or the last dose date (whichever occurred last) minus the first dose date plus 1. The total number of years (48 weeks) on study is equal to the number of days on study divided by 336. Pulmonary exacerbation events per year (48 weeks) are reported.|through Week 24|FAS.|||pulmonary exacerbation events per year|||Number
2635058|NCT01807923|Secondary|Percentage of Participants With Response Based on Percent Predicted FEV1|A participant was considered as a responder if the participant had >=5% increase from baseline in average percent predicted FEV1 at Week 16 and at Week 24 (relative change). FEV1 and percent predicted FEV1 are defined in OM 1. A participant with a missing average relative change from baseline in percent predicted FEV1 at Week 16 and at Week 24 was considered as a non-responder.|Week 16 and 24|FAS.|||percentage of participants|||Number
2635062|NCT01807923|Primary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24|Absolute change from baseline at Week 24 was assessed as the average treatment effect at Week 16 and at Week 24. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, race, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years.|Baseline, Week 16 and 24|Full Analysis Set (FAS) included all randomized participants who received any amount of study drug. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.|||percent predicted of FEV1||Standard Error|Least Squares Mean
2635063|NCT01807871|Secondary|Adverse Drug Effects|To test whether the incidence of adverse drug effects during the post-lapse use of nicotine patch is minimal.|Up to 12 weeks|All randomized participants|||Participants|||Count of Participants
2635064|NCT01807871|Secondary|Mediators of Effect of Post-lapse Nicotine Replacement Therapy Use on Abstinence|To test whether the amount of use of nicotine patch post-lapse, craving, withdrawal, cigs/day, motivation to quit, confidence in quitting, nicotine reinforcement from cigarettes, and self-efficacy mediate any effect of post-lapse patch use on abstinence.|4 months after the quit date|Because the results for the primary outcome were negative, this outcome was not analyzed (i.e., there was no effect to mediate).||||||
2635065|NCT01807871|Primary|Point-prevalent Abstinence at 4 Months|"To test our hypothesis that among the subset of the 701 enrolled participants who quit smoking and then lapsed while using the nicotine patch, those randomized to continue the patch post-lapse will be more likely to be 7-day point-prevalent abstinent at 4 month follow-up than those randomized to discontinue the patch post-lapse. 7-day point prevalent abstinence was assessed by response to the question In the last 7 days, on how many days did you smoke on the 4 month follow-up survey. Respondents who replied 0 were classified as Yes for 7-day point-prevalent abstinence; all other responses (including missing) were classified as No."|4 months after the quit date|Participants who lapsed while using the nicotine patch|||Participants|||Count of Participants
2635066|NCT01807650|Secondary|Adverse Events by Relationship to Study Medication|Adverse events were assessed as being 'unlikely', 'possibly' or 'probably' related to study medication, 'not related' to study medication or the relationship to study medication was rated as 'unknown'.|Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).|The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Participants with adverse events (%)|||Number
2635067|NCT01807650|Secondary|Severity of Adverse Events|Adverse Events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) as being mild (NCI CTCAE Grade 1), moderate (NCI CTCAE Grade 2), severe (NCI CTCAE Grade 3), life-threatening (NCI CTCAE Grade 4) or death (NCI CTCAE Grade 5).|Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).|The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Participants with adverse events (%)|||Number
2635068|NCT01807650|Secondary|Frequency of Adverse Events||Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).|The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Participants with adverse events (%)|||Number
2635069|NCT01807650|Secondary|Pharmacokinetic (PK) Data (Plasma Betulin Concentration)|Systemic presence/concentration of betulin in blood plasma samples - values for the number of samples with measurable values in samples above the lower limit of quantification (LLOQ) of 1 ng/mL|up to 4 weeks|A total of 13 participants had a total of 15 samples with betulin concentrations above the LLOQ (1 ng/mL), 2 participants with 2 samples each above LLOQ|||Betulin (ng/mL)|Samples above LLOQ|Full Range|Mean
2635070|NCT01807650|Secondary|Pharmacokinetic (PK) Data (Number of Plasma Samples With Measurable Betulin Concentration)|Systemic presence/concentration of betulin in blood plasma samples. Plasma samples were collected in weekly intervals and at the end of treatment (when wound closure was achieved or at Day 28). Samples were analysed in a central laboratory with a validated LC-MS/MS method with a lower limit of quantification (LLOQ) of 1 ng/mL.|up to 4 weeks|The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Plasma Samples|Plasma Samples||Number
2635071|NCT01807650|Secondary|Likert Scale Rating of Tolerability|Participants and investigators were asked to evaluate the tolerability of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only (standard of care) on a 5-point Likert scale (treatment with Oleogel-S10 is much better tolerated, treatment with Oleogel-S10 is better tolerated, both treatments are equally well tolerated, non-adhesive wound dressing only is better tolerated, non-adhesive wound dressing only is much better tolerated).|2 to 4 weeks|The safety analysis population (SAF) included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Percentage of participants|||Number
2635072|NCT01807650|Secondary|Cosmetic Outcome at 3 and 12 Months After Surgery, Respectively|Blinded photographic evaluation which wound half resembles more closely the surrounding skin with regard to texture, redness, growth of hair, and pigmentation.|3 months and 12 months|"The intent-to-treat (ITT) analysis population included 96 participants for the 3-months follow-up and 65 participants for the 12-months follow-up.~*Note: The assessment for one patient was missing as no photo was not taken at the Month 3 follow-up visit, therefore this outcome measure is based on 95 patients"|||Percentage of wounds||95% Confidence Interval|Number
2635082|NCT01807624|Secondary|SpO2 Decrease of > 5% on 2 Consecutive Measurements After Administration of Study Medication||0, 5, 10, 15, 20, 25, 30, 40, 50 minutes, and 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours after completion of the last nasal spray||||participants|||Number
2635073|NCT01807650|Secondary|Likert Scale Rating of Efficacy|Participants and investigators were asked to grade the efficacy of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only on a 5-point Likert scale (treatment with Oleogel-S10 is much more effective, treatment with Oleogel-S10 is more effective, both treatments have the same efficacy, non-adhesive wound dressing only is more effective, non-adhesive wound dressing only is much more effective).|2 to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form.|||Percentage of efficacy assessments||95% Confidence Interval|Number
2635074|NCT01807650|Secondary|Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator|A study team member assessed the progress of wound healing by treatment regimen and noted the degree of epithelialization (expressed in percent of the original wound size) at wound dressing changes on Day 7, Day 10, Day 14, Day 18, Day 21, and Day 28.|2 to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form.|||Area Percent of initial wound size||95% Confidence Interval|Mean
2635075|NCT01807650|Secondary|Percentage of Participants With Wound Closure at Different Time Points|For separate time points (Day 7, Day 10, Day 14, Day 18, Day 21, and Day 28), the frequencies of wound areas which have reached wound closure were calculated.|2 to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. Data were missing for n=2 participants at all time points.|||Percentage with wound closure||95% Confidence Interval|Number
2635076|NCT01807650|Secondary|Percentage of Participants With Earlier Healing|Percentage of participants with earlier healing of wound area treated with Oleogel-S10 and non-adhesive wound dressing compared to non-adhesive wound dressing only|2 to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form.|||Percentage with earlier healing||95% Confidence Interval|Number
2635077|NCT01807650|Secondary|Time From Surgery Until Wound Closure is Achieved|Time from surgery until wound closure is achieved, separately for wound halves treated with Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing only. While outcome measure 1 (intra-individual difference in time to wound closure) was calculated based on mean intra-individual difference in time to wound closure in 110 participants with missing values replaced by a value of 0, for outcome measure 2 missing values were not replaced. For 2 of the 110 wounds data were missing, thus the reported values are calculated from 108 STSG donor site wound halves by intervention (Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing only).|2 to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. For 2 of the 110 wounds, data were missing, thus the reported values are calculated from 108 STSG donor site wound halves by intervention|||Days from surgery until wound closure|STSG Wound (Halves)|95% Confidence Interval|Mean
2635078|NCT01807650|Primary|Intra-individual Difference in Time to Wound Closure|Intra-individual difference in time to wound closure between wound halves, either treated with Oleogel-S10 and non-adhesive wound dressing or treated with non-adhesive wound dressing only. Independent experts were blind to treatment and assessed efficacy based on chronological series of cropped and coded photographs by wound half that were taken before start of treatment, during wound dressing changes and at the end of treatment. Difference in time to wound closure was calculated for every individual participant as [time taken for wound half treated with Oleogel-S10 to close] - [time taken for wound half treated with non-adhesive wound dressing to close], i.e., results below 0 indicate earlier wound closure of Oleogel-S10 treatment. The overall mean difference in time to wound closure was calculated based on all mean differences in time to wound closure of individual participants. Hence, primary outcome data derived from mean difference in time to wound closure by participant.|2 to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form.|||days||95% Confidence Interval|Mean
2635079|NCT01807637|Secondary|Change From Baseline in Stroke Impact Scale Scores|The Stroke Impact Scale-16 (SIS-16, completed by study team) is a standardized instrument 36-38 that assesses 3 functional domains in stroke patients including ADL / IADL, mobility, and social and occupational engagement. It consists of 64 - 5 point likert scale questions with a total score range of 64(lowest) to 320 (highest).|Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).||||units on a scale||Standard Error|Mean
2635080|NCT01807637|Secondary|Slope of Recruitment Curve. Change From Baseline in the Slope of the Recruitment Curve Based on Motor Evoked Potentials (MEPs).|A Magstim 200 super rapid2 stimulator with a 110 mm double cone coil will deliver stimulation. First, the TMS motor threshold (MT) will be established and the best location for eliciting MEPs from the contralesional and ipsilesional TA muscle will be tracked on the subject's MRI scan in Brainsight. Recruitment curves will be obtained as follows: 1) delivering ten, single TMS pulses beginning at 70% of MT, 2) increasing TMS intensity by 10% and repeating the process up to 160% of the MT or until a plateau in the recruitment curve is reached, 3) offline data processing will be performed with the Matlab curve fitting toolbox and 4) the threshold, slope, and MEPmax, and the goodness of fit (R2) will be calculated. A change in the slope of the recruitment curve will indicate change in cortical excitability.|Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).||||Slope of a regression line||Standard Error|Mean
2635081|NCT01807637|Primary|Ankle Dorsiflexion Angle. Change From Baseline in Ankle Dorsiflexion Angle During the Swing Phase of Gait|Over ground laboratory assessments of gait: 1) Gait velocity and spatiotemporal gait parameters will be measured with the GAITRite system (CIR Systems, Inc., Havertown, PA) 28-35. 2) Hip, ankle, and knee angles during gait will be measured using the Simi Aktisys gait analysis system (Simi Reality Motion Systems; Postfach, Unterschleissheim Germany). LED markers are placed on the participant's lower extremity. Ankle, knee, and hip angle data is obtained simultaneously to evaluate motor strategies for overcoming gait impairments. Both types of data will be collected simultaneously as participants walk 10 meters across the GAITRite walkway at a self-selected speed for 5 repetitions.|Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).||||degrees||Standard Error|Mean
2635095|NCT01807598|Secondary|Progression-free Survival (PFS)|"Progression-free survival (PFS) is defined as the time from the date of start of treatment until disease progression; death; or initiation of new therapy. The outcome is reported as the mean number of days of PFS, with 95% confidence interval.~Progressive disease (PD) is any of the following:~Worsening of any organ damage~Doubling of any laboratory abnormality~New transfusion dependence of ≥ 4 units red cells or platelets at 8 wk~≥ 100% increase in transfusions for 8 wk~10-cm+ splenomegaly"|Up to 1 year||||Days||95% Confidence Interval|Mean
2635096|NCT01807598|Secondary|Time to Response (TTR)|Time to response (TTR) is defined as the time from the date of start of treatment to the date of first confirmed response. For participants with a confirmed clinical response, the outcome was to be reported as the median TTR with standard deviation.|Up to 1 year|Time to response (TTR) can not be determined if no participants had a response.||||||
2635097|NCT01807598|Secondary|Duration of Response (DOR)|Duration of response (DOR) is defined as the time from the start of the first confirmed response until the date of the first documented and confirmed disease progression or death due to ASM or MCL. For participants with a confirmed clinical response, the outcome was to be reported as the median DOR with standard deviation.|Up to 1 year|Duration of response (DOR) can not be determined if no participants had a response.||||||
2635098|NCT01807598|Secondary|Quality of Life (QoL) Score Using a Modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)|"Overall quality of life (QoL) was assessed by a single specific question from the 36-question Myeloproliferative Neoplasm Symptom Assessment Form with Mast Cell Disorder Symptoms [(MPN-SAF(MCD)] survey. Possible responses for theQoL question range from 0 to 10, with 0 indicating as good as it can be (most favorable), and 10 meaning as bad as it can be (least favorable). The QoL score was obtained at baseline and after treatment. The outcome is reported as mean score with dispersion."|Up to 1 year||||score on a scale||Standard Deviation|Mean
2635099|NCT01807598|Secondary|Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Total Symptom Score|The clinical effect of patient symptoms associated with systemic mastocytosis or mast cell leukemia were assessed with the patient-reported outcome survey entitled Myeloproliferative Neoplasm Symptom Assessment Form with Mast Cell Disorder Symptoms [(MPN-SAF(MCD)]. The MPN-SAF(MCD) is a 36-question survey, with possible responses ranged from 0 to 10, with 0 indicating not present or no effect; 1 meaning present but most favorable; and 10 meaning worst imaginable (least favorable). Total range is 0 to 360, with 0 being best possible, and 360 being worst possible. Total symptom score is calculated as the sum of the individual survey scores reported at baseline and after treatment, with lower numbers indicating less effect, and larger numbers indicated greater effect. The outcome is reported as mean score value with dispersion.|Up to 1 year||||score on a scale||Standard Deviation|Mean
2635100|NCT01807598|Secondary|Percent Change of CD30 Expression on Neoplastic Mast Cells|The presence of the CD30 marker (epitope) on neoplastic (cancerous) mast cells in core bone marrow biopsy samples was assessed by immunohistochemical methods, before and after brentuximab vedotin treatment. CD30 is a member of the TNF-receptor (TNF-R) superfamily, and is a transmembrane glycoprotein receptor that is normally at very low levels on the surface of activated T-cells. Overexpression of the CD30 marker is indicative of T-cell lymphoproliferative disorders and neoplastic mast cells, and the effect of a particular treatment on CD30 expression may be related to the efficacy of that treatment. The outcome is reported as the median percentage change in the level of CD30 detected, reported with full range.|Baseline and up to 1 year|CD30 marker data was not obtained for some participants.|||percentage change in CD30+ cells||Full Range|Median
2635101|NCT01807598|Secondary|Brentuximab Vedotin Toxicity|Toxicity was assessed as the number of adverse events considered possibly, probably, or definitely-related to treatment with brentuximab vedotin. The outcome is reported as the total number of related events, a number without dispersion, and the number of related events (without dispersion) considered to be either a hematologic toxicity or non-hematologic toxicity.|Up to 1 year||||Related adverse events|||Number
2635102|NCT01807598|Primary|Overall Response Rate (ORR) Per Consensus International Response Criteria (Rate of Complete or Partial Remissions or Clinical Improvement)|"Overall response rate (ORR) is sum of complete response (CR); partial response (PR); and clinical improvement (CI) in 1 year, ie, ORR=CR+PR+CI. The outcome is the number of participants without dispersion.~CR is following with response duration(RD) ≥12 weeks (wk)~No mast cell disease~Tryptase <20 ng/mL~Neutrophils ≥1x10e9/L with normal differential~Hemoglobin ≥11 g/dL~Platelets ≥100x10e9/L~No hepatosplenomegaly~No systemic mastocytosis(SM)-related organ damage PR is following with RD ≥12wk~Neither CR or progressive disease(PD)~Neoplastic mast cells reduced ≥50%~Tryptase reduced ≥50%~1+ disease finding resolved CI is following with RD ≥12wk~Neither CR; PR; or PD~1+ of findings above Stable disease (SD) Not CR, PR, Cl, or PD Progressive disease (PD)~Any of:~Worsening organ damage~Doubling of laboratory abnormality~New transfusion dependence of ≥4 units red cells or platelets at 8wk~•+ ≥100% in transfusions for 8wk~10-cm+ splenomegaly"|Up to 1 year|1 of 10 participants were not evaluable due to early death during Cycle 1 (considered unrelated to study treatment)|||participants|||Number
2635103|NCT01807585|Secondary|Ecchymosis at Day 3|"At the Day 3 visit, the investigator visually rated the subject's ipsilateral leg for the occurrence of ecchymosis along the treated area based on a Scale for Ecchymosis Assessment with a 0-5 rating scale, with 0 being the best possible outcome and 5 being the worst possible outcome.~The treatment area was defined as the area of skin overlying the treated vein, excluding the 5 cm of skin immediately adjacent to the access site.~The rating scale was based on the percentage of ecchymosis of the treated area according to the following criteria:~0 rating = no ecchymosis,~rating = less than 25% ecchymosis,~rating = 25-50% ecchymosis,~rating = 50-75% ecchymosis,~rating = 75-100% ecchymosis,~rating = extension of ecchymosis above or below the treated area."|First follow up visit at day 3|Completed Case (CC) analysis population consisted of all treated subjects for whom data were available for the endpoint.|||Participants|||Count of Participants
2635104|NCT01807585|Secondary|Intraoperative Pain|After the procedure, pain experienced during the procedure was rated by the subjects on a 0-10 numeric rating scale (NRS) where 0 represents no pain whatsoever and 10 represents worst imaginable pain.|During the operative procedure, which was an average of 24 minutes for VenaSeal SCS, 19 minutes for RFA, and 31 minutes for Roll-in group.|Completed Case (CC) analysis population consisted of all treated subjects for whom data were available for the endpoint.|||scores on a scale||Standard Deviation|Mean
2637126|NCT01784848|Secondary|Absolute Change From Baseline on Fasting Plasm Glucose Level, HbA1c and Insulin Resistance|Change from baseline on fasting plasm glucose level, HbA1c and insulin resistance|12, 24, 36, 48 and 60 months|||||||
2635105|NCT01807585|Primary|Number of Participants With Complete Closure of the Target Vein at 3 Months|The primary endpoint of the study was complete closure of the target vein at 3 months after index treatment as judged by the vascular ultrasound laboratory. Complete closure was defined as Doppler ultrasound examination showing closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm.|3 months|Primary effectiveness was analyzed on the randomized cohort only and used an Intent to Treat (ITT) population, consisting of all treated subjects. The difference in success rates was calculated after imputing missing values with various methods.|||Participants|||Count of Participants
2635106|NCT01807520|Secondary|Number of Participants Who Develop Immunogenicity Against Secukinumab|The number of participants who tested positive for anti-secukinumab antibodies. It refers to the number of participants who had no positive values at baseline but developed them only after start of secukinumab treatment. None of the participants had a loss of efficacy and the test was only transiently positive.|Week 132|Participants from the safety set was analyzed. The safety set included all participants who took at least one dose of study treatment.|||Participants|||Number
2635107|NCT01807520|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index 75 (PASI75) and Investigator Global Assessment (IGA Mod 2011) Response 0 or 1 Over Time up to Week 16 of the Treatment Compared to Placebo and Over Time up to Week 132|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). The IGA scale referred exclusively to the participant's disease at the time of the assessment. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe. To be considered IGA responder at any point in time, the patient must have an IGA score of 0 or 1 and have achieved a reduction of at least two points on the IGA scale from baseline.|16 weeks, 132 weeks|Participants from the FAS, who had evaluable data at a given time point, were analyzed for that time point. The FAS consisted of all randomized participants to whom treatment was assigned. Multiple imputation was applied where the number of evaluable participants was based on a rounded mean number of responders for 500 imputations.|||Percentage of participants|||Number
2635108|NCT01807520|Secondary|Percent Change From Baseline in NAPSI Score|The NAPSI is a tool to assess psoriatic nail involvement in patients with nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0-4) and nail bed psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail gets a nail matrix score and a nail bed score, the total of which is the NAPSI score for that nail ranging from 0 to 8. All 10 fingernails are assessed giving a total NAPSI score ranging from 0 to 80. A negative change from baseline indicates improvement.|baseline, 16 weeks, 132 weeks|Only participants from the full analysis set (FAS) who had values at both baseline and the post-baseline time point, were analyzed. The FAS consisted of all randomized participants to whom treatment was assigned. The analysis was based on Last Observation Carried Forward (LOCF).|||percent change||Standard Deviation|Mean
2635109|NCT01807520|Primary|Percentage Change From Baseline in Nail Psoriasis Severity Index (NAPSI) After 16 Weeks of Treatment|The NAPSI is a tool to assess psoriatic nail involvement in patients with nail psoriasis. Each nail is divided with imaginary horizontal and longitudinal lines into quadrants. Each nail is given a score for nail matrix psoriasis (0-4) and nail bed psoriasis (0-4) depending on the presence of any of the features of nail psoriasis in that quadrant. Each nail gets a nail matrix score and a nail bed score, the total of which is the NAPSI score for that nail ranging from 0 to 8. All 10 fingernails are assessed giving a total NAPSI score ranging from 0 to 80. A negative change from baseline indicates improvement. The adjusted mean is presented.|Baseline, 16 weeks|Only participants from the full analysis set (FAS) who had values at both baseline and week 16, were analyzed. The FAS consisted of all randomized participants to whom treatment was assigned. The analysis was based on Last Observation Carried Forward (LOCF).|||percent change||Standard Error|Mean
2635110|NCT01807455|Secondary|Adverse Event Reporting During the Study|Number of subjects reporting at least one adverse event (assessed as unrelated or related to treatment)|36 weeks||||participants|||Number
2635111|NCT01807455|Secondary|Assessment of Local Tolerability After Treatment|Number of subjects reporting anticipated injection-related reactions after treatment|14 days||||participants|||Number
2635112|NCT01807455|Secondary|Evaluation of Acne Scarring Using the Scale for Acne Scar Severity (SCAR-S)|Percentage of subjects improved at 36 weeks after first treatment session assessed using SCAR-S. Scale range is Very severe, Severe, Moderate, Mild, Almost clear and Clear. The alternative Clear is considered the best outcome. Improvement is considered to be at least one step improvement on the scale toward the alternative Clear.|36 weeks||||percentage of participants|||Number
2635113|NCT01807455|Secondary|Evaluation of Skin Quality and Overall Satisfaction Using a Subject Satisfaction Questionnaire|Percentage of subjects satisfied with the overall appearance of the face at 36 weeks after first treatment session. Scale range is Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied and Very satisfied. Alternatives Somewhat satisfied to Very satified are considered a better outcome.|36 weeks||||percentage of participants|||Number
2635114|NCT01807455|Primary|Evaluation of Acne Scarring and the Surrounding Skin Using the Global Aesthetic Improvement Scale|Percentage of improved subjects at 36 weeks after first treatment session assessed using Subject GAIS. Scale range is Worse, No Change, Somewhat Improved, Much Improved and Very Much Improved. Alternatives Somewhat Improved to Very Much Improved are considered an improvement, i.e. a better outcome.|36 weeks||||percentage of participants|||Number
2635115|NCT01807299|Primary|Conners Scale|Scores on the Conners scale. Scores above 60 indicate ADHD. Minimum 0 and a maximum of 126.|3 months|Conners scale and the child stress scale (ESI)|||units on a scale||Standard Deviation|Mean
2635116|NCT01807234|Secondary|Time to Pain Relief|9) The time, in minutes, will be measured from the time study drug is taken to the time when significant pain relief is first observed and maintained through 2 hours with no rescue medication use at or prior to this point.|following each treated migraine attack||||percentage of patients||95% Confidence Interval|Number
2635117|NCT01807234|Secondary|Sustained Pain Freedom (SPF)|8) 24 and 48 hours sustained pain freedom (SPF); Defined as the reduction of pain to none. Pain was assessed using a 4-point scale (none, mild, moderate, and severe).|24 and 48 hours||||percentage of patients||95% Confidence Interval|Number
2635118|NCT01807234|Secondary|Sustained Pain Relief (SPR)|7) 24 and 48 hours sustained pain relief (SPR) Defined as the reduction of pain to none or mild from moderate or severe, on a 4-point scale (none, mild, moderate, and severe).|24 and 48 hours||||percentage of patients||95% Confidence Interval|Number
2635119|NCT01807234|Secondary|Self-assessment of Disability: Percentage of Participants With Moderate or Severe Disability|Participants' self-assessment of disability was assessed using 4-point scales (none, mild, moderate, and severe). A binary outcome variable was created grouping none and mild vs moderate to severe. .|2-hours||||percentage of patients||95% Confidence Interval|Number
2635120|NCT01807234|Secondary|Absence of Allodynia|5) Absence of allodynia The presence of allodynia was assessed based on a series of 8 questions inquiring as to the presence of allodynia. Participants answering 2 or more questions positively were considered to have allodynia.|2-hours||||percentage of patients||95% Confidence Interval|Number
2635121|NCT01807234|Secondary|Absence of Nausea|4) Defined as reduction of nausea to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)|2-hours||||percentage of patients||95% Confidence Interval|Number
2635122|NCT01807234|Secondary|Absence of Phonophobia|3) Defined as reduction of phonophobia to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)|2-hours||||percentage of patients||95% Confidence Interval|Number
2635123|NCT01807234|Secondary|Absence of Photophobia|2) Defined as reduction of photophobia to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)|2-hours||||percentage of patients||95% Confidence Interval|Number
2635124|NCT01807234|Secondary|Pain Freedom|1) Pain Freedom: Pain Freedom at 2 hours is defined as being free of pain. Pain was assessed using a 4-point scale (none, mild, moderate, and severe).|2-hours||||percentage of patients||95% Confidence Interval|Number
2635125|NCT01807234|Primary|2- Hour Pain Relief|The primary outcome was 2-hour headache relief; headache relief was defined as headache pain from moderate or severe pain to none or mild pain. Pain was assessed using a 4-point scale (none, mild, moderate, and severe)|2 hours||||percentage of participants||95% Confidence Interval|Number
2635126|NCT01807156|Secondary|Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|"Measurable lesions: Lesions that can be measured in at least one dimension as ≥ 20 mm with conventional CT scan techniques or as ≥ 10 mm with spiral CT scan.~Non-measurable lesions: All other lesions including small lesions (longest diameter < 20 mm with conventional techniques) and other non-measurable lesions including: pleural effusions, ascites, and disease documented by indirect evidence (e.g. biochemical abnormalities).~Target lesions: All measurable lesions up to a maximum of 5 lesions. Target lesions are selected for their size and suitability for accurate repetitive measurements. The sum of the longest diameter of all target lesions will be calculated and reported as the baseline sum longest diameter (LD). This will be used as a reference to further quantify objective response.~Non-target lesions: All other lesions are identified as non-target lesions and should be followed as present or absent."|6 months|No response was observed in any of the patients.|||participants|||Number
2635127|NCT01807156|Primary|Number of Patients With Advanced Hepatocellular Cancer (HCC) Receiving Tivozanib Who Are Free From Progression|Evaluation of disease progression in the patients with advanced hepatocellular cancer (HCC) receiving tivozanib will be made using CT or MRI scan of the organ(s) with the target lesion(s). Response Evaluation Criteria In Solid Tumors (RECIST) criteria 1.1 will be used for objective tumor response assessment. Measurable lesions can be measured in at least one dimension as ≥ 20 mm with conventional CT scan techniques or as ≥ 10 mm with spiral CT scan. Target lesions are all measurable lesions up to a maximum of 5 lesions. Target lesions are selected for their size and suitability for accurate repetitive measurements. The sum of the longest diameter of all target lesions will be calculated and reported as the baseline sum longest diameter (LD). This will be used as a reference to further quantify objective response.|6 Months||||participants|||Number
2635128|NCT01807104|Primary|Returning to Quality of Life by Using Either Anterior Approach Versus Posterior Approach|Harris Hip 5-Year Total Score Change from Baseline. The Harris Hip score gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the Harris Hip score, the less dysfunction.This outcome measure has been validated for joint replacement surgery for peer reviewed orthopedic literature.|5 years||||score on a scale||Standard Deviation|Mean
2635129|NCT01807026|Secondary|Cohort C: Mean QTcF Value at Cmax|The mean QTcF value at Cmax for participants administered a single dose of 280 mg LY2886721 was reported. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Time matched mean change from baseline in QTcF = time matched plasma concentration + participant + random error.|Predose up to 48 hours after administration of study drug|Participants who received at least one dose of LY2886721 at the 280-mg dose level and with evaluable mean QTcF data.|||milliseconds (ms)||90% Confidence Interval|Mean
2635130|NCT01807026|Primary|PD: Cnadir of CSF Aβ 1-40|Plasma concentration of Aβ1-40 was summarized based on Cnadir following administration of a single dose of 70 mg LY2886721 or a single dose of LY2886721-matching placebo.|Predose up to 36 hours after administration of study drug|Participants who received at least one dose of LY2886721 at the 70-mg dose level or placebo and had evaluable CSF Aβ 1-40 data.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2635131|NCT01807026|Primary|Pharmacodynamics (PD): Cnadir of Plasma Amyloid β (Aβ)1-40|Plasma concentration of Aβ1-40 was summarized based on lowest observed concentration (Cnadir).|Predose, up to 96 hours after administration of study drug|Participants who received at least one dose of LY2886721 or placebo and had evaluable plasma Aβ 1-40 data.|||picograms/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2635132|NCT01807026|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of CSF LY2886721|Cmax following administration of a single dose of 70 mg LY2886721.|Predose through 36 hours after administration of study drug|Participants who received at least one dose of LY2886721 at the 70-mg dose level and with evaluable CSF LY2886721-concentration data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2635133|NCT01807026|Primary|Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Cerebrospinal Fluid (CSF) LY2886721|AUC0-∞ following administration of a single dose of 70 mg LY2886721.|Predose through 36 hours after administration of study drug|Participants who received at least one dose of LY2886721 at the 70-mg dose level and with evaluable CSF LY2886721-concentration data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2635134|NCT01807026|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Plasma LY2886721|Cmax following administration of a single dose of 70 or 280 mg LY2886721.|Predose through 96 hours after administration of study drug|Participants who received at least one dose of LY2886721 and with evaluable plasma LY2886721-concentration data.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2635135|NCT01807026|Primary|Pharmacokinetics: Area Under the Curve Extrapolated to Infinity (AUC0-∞) of Plasma LY2886721|AUC0-∞ following administration of a single dose of 70 or 280 mg LY2886721.|Predose through 96 hours after administration of study drug|Participants who received at least one dose of LY2886721 and with evaluable plasma LY2886721-concentration data.|||nanograms*hours/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2635136|NCT01807000|Primary|Percent Total Radioactivity Excreted in Stool of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set|||percentage of radioactivity||Standard Deviation|Mean
2635137|NCT01807000|Primary|Percent Total Radioactivity Excreted in Urine of Radiolabelled Prucalopride Succinate||240 hours post-dose|Pharmacokinetic Analysis Set|||percentage of radioactvity||Standard Deviation|Mean
2635138|NCT01807000|Primary|Half-Life Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set|||hours||Standard Deviation|Mean
2635139|NCT01807000|Primary|Tmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set|||hours||Full Range|Median
2635140|NCT01807000|Primary|Cmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set|||ng equivalents/ml||Standard Deviation|Mean
2635141|NCT01807000|Primary|AUC 0→∞ Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set|||ng equivalents*h/ml||Standard Deviation|Mean
2635142|NCT01807000|Primary|Half-Life Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set|||hours||Standard Deviation|Mean
2635143|NCT01807000|Primary|Tmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set|||hours||Full Range|Median
2635144|NCT01807000|Primary|Cmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set|||ng equivalents/ml||Standard Deviation|Mean
2635145|NCT01807000|Primary|AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate||Over 240 hours post-dose|Pharmacokinetic Analysis Set|||ng equivalents*h/ml||Standard Deviation|Mean
2635146|NCT01807000|Primary|Volume of Distribution (Vz/F) of Radiolabelled Prucalopride Succinate|The distribution of a medication between plasma and the rest of the body.|Over 240 hours post-dose|Pharmacokinetic Analysis Set|||Liters||Standard Deviation|Mean
2635147|NCT01807000|Primary|Total Body Clearance (CL/F) of Radiolabelled Prucalopride Succinate|The rate at which a drug is removed from the body.|Over 240 hours post-dose|Pharmacokinetic Analysis Set|||L/h||Standard Deviation|Mean
2635148|NCT01807000|Primary|Plasma Half-Life (T1/2) of Radiolabelled Prucalopride Succinate|The time it takes for the blood plasma concentration of a substance to halve.|Over 240 hours post-dose|Pharmacokinetic Analysis Set|||hours||Standard Deviation|Mean
2635149|NCT01807000|Primary|Time to Maximum Plasma Concentration (Tmax) of Radiolabelled Prucalopride Succinate|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Over 240 hours post-dose|Pharmacokinetic Analysis Set|||hours||Full Range|Median
2635150|NCT01807000|Primary|Maximum Plasma Concentration (Cmax) of Radiolabelled Prucalopride Succinate|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.|Over 240 hours post-dose|Pharmacokinetic Analysis Set|||ng/ml||Standard Deviation|Mean
2635151|NCT01807000|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled Prucalopride Succinate|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 240 hours post-dose|The Pharmacokinetic Analysis Set included all subjects with at least 1 pharmacokinetic parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set which included all subjects who took 1 dose of investigational product, underwent plasma pharmacokinetic sampling, and had evaluable pharmacokinetic assay results.|||ng*h/ml||Standard Deviation|Mean
2635152|NCT01806961|Secondary|Number of Newly Occurred Dermal Adverse and Serious Adverse Events on the Previous Treatment Area|recording of adverse events|at 6 and 12 months|||||||
2635153|NCT01806961|Secondary|Follow-up of AK-lesions (Existing Lesions, New Lesions, Changes)|clinical examination|at 6 and 12 months|||||||
2635154|NCT01806961|Primary|Determine the Recurrence Rate of AK-lesions|Number of patients with persistent complete clearance at 6 and 12 months follow-up. Recurrence rate is to be determined at the same treatment area where the investigational medicinal products were administered in the previous trial.|at 6 and 12 months|No subject was analysed due to premature study termination (sponsor's decision) therefore no data was available for analysis||||||
2635164|NCT01806896|Primary|Number of Participants With Potentially Clinically Significant Vital Signs Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate less than (<)40 or greater than (>)120 beats per minute (bpm), standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of greater than or equal to (>=)30 millimeters of mercury (mmHg) change from baseline or SBP <90 mmHg, diastolic blood pressure (DBP) >=20 mmHg change from baseline or DBP <50 mmHg.|Baseline up to Day 38|The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo.|||participants|||Number
2637127|NCT01784848|Secondary|Absolute Change From Baseline on Waist Circumference|Absolute change from baseline on waist circumference|12, 24, 36, 48 and 60 months|||||||
2635155|NCT01806896|Secondary|Change From Baseline in Grip Strength Incentive Motivation Task at Day 28: Percent of Maximum Voluntary Contraction (MVC)|This incentive force task was developed to independently dissociate the degree to which a participant responds to reward motivation versus emotional motivation. The task itself included 12 repetitions of 9 trial types, for a total of 108 trials, grouped in a single session lasting about 20 minutes. The trial types were generated according to a combination of 3 emotional categories (negative, neutral, and positive pictures presented) and to 3 monetary incentives (0.01, 0.1, and 1€). Emotional categories and monetary incentives were randomly distributed over the trials and the sequence was fixed such that all subjects were assessed on the exact same task. For each trial, the subject was first presented with an emotional picture displayed on screen for 3000 milliseconds (ms).|Baseline, Day 28|The analysis population included all participants randomized, who had taken at least 1 dose of PF-02545920 or placebo and who had valid data (acceptable task engagement). n=number of participants analyzed in the respective arms. The PPS table was used, not the FAS table.|||percentage of MVC||90% Confidence Interval|Least Squares Mean
2635156|NCT01806896|Primary|Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 28|C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than 1 category.|Day 28|The full analysis population included all participants randomized and had taken at least 1 dose of PF-02545920 or placebo.|||participants|||Number
2635157|NCT01806896|Primary|Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Day 7|C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than 1 category.|Day 7|The full analysis population included all participants randomized and had taken at least 1 dose of PF-02545920 or placebo.|||participants|||Number
2635158|NCT01806896|Secondary|Change From Baseline in Functional Magnetic Resonance Imaging (fMRI) in Monetary Incentive Delay (MID) Task at Day 28|The monetary incentive delay (MID) task is established as a reliable method to elicit ventral striatal (VS) activity in relation to reward/punishment anticipation and tracked with dysfunctionalities across a range of conditions in which incentive motivation is thought to be abnormal (schizophrenia, depression, substance abuse, and pathological gambling). Pharmacological intervention has demonstrated reversal of observed deficit. The beta contrast value of 'REW' is for analysis of reward-related activity in VS within the task-related 'reward network' during the gain condition (relative to neutral) of the MID task. The changes in beta contrasts (fMRI) provided are changes in parameter estimates and do not have a unit of measure.|Baseline (Day 1), Day 28|The analysis population included all participants randomized, who had taken at least 1 dose of PF-02545920 or placebo and who had valid data (thresholded by acceptable motion). n=number of participants analyzed in the respective arms. The per-protocol set (PPS) table was used, not the full analysis set (FAS) table.|||beta contrasts||90% Confidence Interval|Least Squares Mean
2635159|NCT01806896|Primary|Number of Participants With Suicidal Tendencies (C-SSRS Mapped to C-CASA) at Baseline|C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: completed suicide, suicide attempt, preparatory acts towards imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than 1 category.|Baseline (Day 1)|The full analysis population included all participants randomized and had taken at least 1 dose of PF-02545920 or placebo.|||participants|||Number
2635160|NCT01806896|Primary|Change From Baseline in Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score at Day 28|The UHDRS is a clinical rating scale to provide a uniform assessment of the clinical features and course of Huntington Disease. The Total Motor Score (TMS) is 1 of the 6 components of UHDRS, includes 31 items, and ranges from a scale of 0 to 124 (higher scores indicate more severe disease).|Baseline, Day 28|The full analysis population included all participants randomized and had taken at least 1 dose of PF-02545920 or placebo.|||units on a scale||90% Confidence Interval|Least Squares Mean
2635161|NCT01806896|Primary|Categorical Summary of Participants Meeting Stopping Criteria|Absolute neutrophil count (ANC) and WBC were monitored for safety. Participants with WBC <3000 but >=2000 cells/mm^3 or ANC <1500 but >=1000 cells/mm^3 were to have study treatment suspended. Participants with WBC <2000 or ANC <1000 cells/mm^3 were to be discontinued from study participation.|Baseline up to Day 38|The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo.|||participants|||Number
2635162|NCT01806896|Primary|Number of Participants With Change From Baseline in Body Weight of >=7%|Weight assessment was performed by a study physician or a trained study nurse and was included in the physical examination.|Baseline up to Day 38|The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo.|||participants|||Number
2635163|NCT01806896|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG parameters included PR interval, QRS complex, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval ≥200 milliseconds (msec) or ≥25% increase when baseline is >100 msec; QRS interval ≥50% increase from baseline when baseline is less than or equal to (<=)200 msec; and QTcF ≥450 msec or ≥30 msec increase from baseline.|Baseline up to Day 38|The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo.|||participants|||Number
2635231|NCT01806571|Secondary|Duration of Complete Response|The distribution of duration of complete response will be estimated using the method of Kaplan-Meier.|From the date at which objective status is first noted to be CR or CRi to the earliest date relapse is documented, assessed up to 3 years|Patients that acheived a complete response.|||Months||95% Confidence Interval|Median
2635165|NCT01806896|Primary|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern (Without Regard to Baseline Abnormality)|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total and direct bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein/albumin, hemoglobin/blood, ketones/acetone, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (urine/serum pregnancy test, glycosylated hemoglobin [HbA1c, if diabetic]).|Baseline up to Day 38|The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo.|||participants|||Number
2635166|NCT01806896|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of treatment and up to the follow-up period that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious AEs.|Baseline up to Day 38|The safety analysis population included all participants who received at least 1 dose of PF-02545920 or placebo.|||participants|||Number
2635167|NCT01806857|Secondary|Ashworth Spasticity Scale Score - Left Leg|This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Deviation|Least Squares Mean
2635168|NCT01806857|Secondary|Ashworth Spasticity Scale Score - Right Leg|This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Deviation|Least Squares Mean
2635169|NCT01806857|Secondary|Ashworth Spasticity Scale Score - Left Arm|This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Deviation|Least Squares Mean
2635170|NCT01806857|Secondary|Average Solids Swallowing Test|The Time Swallowing Test assesses the subject's ability to swallow solids. For this test, the subject will be asked to consume a tablespoon of cereal containing 5 cheerios. The subject will be instructed to close their mouth, chew and subsequently swallow the bolus. The time to complete this task will be recorded. The test will be completed three times to obtain an average score.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||seconds||Standard Error|Least Squares Mean
2635171|NCT01806857|Secondary|Visual Analog Scale - Salivation (Sialorrhea) Score|Visual analog scales are useful for measuring complex clinical events and offer the advantage of self-administration and responsiveness to change over time. The scales designed for this study inventory three domains of bulbar function: speech, swallowing and salivation (sialorrhea). For each of these, subjects score themselves by indicating their level of function on a scale of 1 (severe impairment) to 10 (normal). Scores range from 1 to 10; the higher the score, the more normal the function.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Error|Least Squares Mean
2635172|NCT01806857|Secondary|Visual Analog Scale - Swallowing Score|Visual analog scales are useful for measuring complex clinical events and offer the advantage of self-administration and responsiveness to change over time. The scales designed for this study inventory three domains of bulbar function: speech, swallowing and salivation (sialorrhea). For each of these, subjects score themselves by indicating their level of function on a scale of 1 (severe impairment) to 10 (normal). Scores range from 1 to 10; the higher the score, the more normal the function.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Error|Least Squares Mean
2635173|NCT01806857|Secondary|Average Water Swallowing Test (WST)|The Water Swallowing Test (WST) estimates swallowing speed, a useful and reproducible measure. While sitting, subjects are asked to drink 30 milliliters (mL) of liquid. The time for subjects to complete this task is a sensitive measure for the detection of swallowing dysfunction and is a simple measure for serial assessment of subjects. The test will be completed three times, with the best two scores recorded to obtain an average score. Following completion of the WST, the subject's swallowing abilities (choking, spillage, and effort) will be observed.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||seconds||Standard Error|Least Squares Mean
2635174|NCT01806857|Secondary|Timed Reading of Test Paragraph Result|Subjects will be asked to read 'The Rainbow Passage' a commonly used test paragraph utilized by speech pathologists to assess speech rate (words/minute). Study staff will time the subject to determine how many words the subject reads per minute. It is used primarily because it contains every sound in the English language. Subjects will also be observed for loudness, nasality, and intelligibility.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||words per minute||Standard Error|Least Squares Mean
2635175|NCT01806857|Secondary|Ashworth Spasticity Scale Score - Right Arm|This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Deviation|Least Squares Mean
2635176|NCT01806857|Secondary|Visual Analog Scale - Speech Scores|Visual analog scales are useful for measuring complex clinical events and offer the advantage of self-administration and responsiveness to change over time. The scales designed for this study inventory three domains of bulbar function: speech, swallowing and salivation (sialorrhea). For each of these, subjects score themselves by indicating their level of function on a scale of 1 (severe impairment) to 10 (normal). Scores range from 1 to 10; the higher the score, the more normal the function.|Average between Baseline Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Error|Least Squares Mean
2635177|NCT01806857|Secondary|ALS Functional Rating Scale- Revised (ALSFRS-R) Total Score|The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.|Average between Screening Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Error|Least Squares Mean
2635178|NCT01806857|Secondary|Center for Neurologic Study - Lability Scale (CNS-LS) Total Score|The Center for Neurologic Study-Lability Scale (CNS-LS) is a 7-item self report scale that assesses pseudobulbar affect (PBA) by measuring the perceived frequency of PBA episodes (laughing or crying). Each item is scored using a 5-point Likert scale, from 1 (applies never) to 5 (applies most of the time). Scores range from 5-35. The higher the score, the worse the PBA.|Average between Screening Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Error|Least Squares Mean
2635179|NCT01806857|Primary|Bulbar Function Scale (CNS-BFS) Swallowing Score|The Center for Neurologic Study-Bulbar Function Scale (CNS-BFS) is a 21-item self report scale that assesses three domains of bulbar function: speech, swallowing and salivation. Scores for each question range from 1 (does not apply) to 5 (applies most of the time). The higher the score, the worse the swallowing. There are 7 swallowing questions, with a score range of 7 to 35.|Average between Screening Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Error|Least Squares Mean
2635180|NCT01806857|Primary|Bulbar Function Scale (CNS-BFS) Speech Score|The Center for Neurologic Study-Bulbar Function Scale (CNS-BFS) is a 21-item self report scale that assesses three domains of bulbar function: speech, swallowing and salivation. Scores for each question range from 1 (does not apply) to 5 (applies most of the time). The higher the score, the worse the speech. There are 7 speech questions, with a score range of 7 to 35.|Average between Screening Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Error|Least Squares Mean
2635181|NCT01806857|Primary|Bulbar Function Scale (CNS-BFS) Sialorrhea Score|The Center for Neurologic Study-Bulbar Function Scale (CNS-BFS) is a 21-item self report scale that assesses three domains of bulbar function: speech, swallowing and salivation. Scores for each question range from 1 (does not apply) to 5 (applies most of the time). The higher the score, the worse the salivation (sialorrhea). There are 7 salivation (sialorrhea) questions, with a score range of 7 to 35.|Average between Screening Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Error|Least Squares Mean
2635182|NCT01806857|Primary|Bulbar Function Scale (CNS-BFS) Total Score|"The Center for Neurologic Study-Bulbar Function Scale (CNS-BFS) is a 21-item self report scale that assesses three domains of bulbar function: speech, swallowing and salivation. Scores for each question range from 1 (does not apply) to 5 (applies most of the time). The higher the score, the worse the speech, swallowing and salivation (sialorrhea). [Range of score: 21-105]~The scale was modeled on the Center for Neurologic Study Emotional Lability Scale (CNS-LS) that has been a robust endpoint in four clinical trials. The scale was validated in a large population of ALS patients (n=122) and detects impaired bulbar function at a sensitivity of 90% and a specificity of 0.97%. Test re-test correlation was 0.92% at six-months (n=53)."|Average between Screening Visit to Visit 3|Includes all participants that received at least one dose of intervention.|||units on a scale||Standard Error|Least Squares Mean
2635183|NCT01806779|Other Pre-specified|Change in Smoking Withdrawal Symptoms|Withdrawal symptoms will be assessed by questionnaire on Quit Day, Week 1, Week 3, Week 7 and Week 11 post target quit date and 6 months post quit Follow-Up (if applicable) using the Shiffman-Jarvik questionnaire, which consists of 33-items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.|Quit Day and 1 week, 3 weeks, 7 Weeks, 11 Weeks and 6 months post Quit Day|A total of 163 subjects (Chantix n=82, Chantix+Zyban n=81) attended the first post-quit visit. However, ten subjects (5 in each condition) failed to complete or return their Quit Day withdrawal questionnaires; therefore change scores could only be calculated for 153 subjects (Chantix n=77, Chantix+Zyban n=76).|||percentage of change||Standard Error|Mean
2635184|NCT01806779|Secondary|Number of Participants Completing Continuous Abstinence From Smoking Between Quit Day and 11-week Post Quit Day Visit|This will be determined by a composite of self-report of no smoking between study visits at the 1-week, 3-week, 7-week and 11-week post Quit Day study visits and expired air carbon monoxide (CO) <10 ppm (measured at those study visits). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.|Quit Day to 11-week post Quit Day study visit||||participants|||Number
2635185|NCT01806779|Secondary|Number of Participants Completing Seven-day Point Abstinence From Smoking at 6 Months Post Quit Day|This will be determined by a self-report of no smoking for the previous seven days when called for 6-month follow-up confirmed by expired air CO.|6 months post Quit Day||||participants|||Number
2635186|NCT01806779|Primary|Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits|This will be determined by a composite of self-report at the 11-week study visit of no smoking between the 8-week and 11-week visits and expired air carbon monoxide (CO) <10 ppm (measured at the 11-week study visit). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.|Period between 8-week and 11-week visits post target Quit Day||||participants|||Number
2637128|NCT01784848|Secondary|Absolute Change From Baseline on BMI|Absolute change from baseline on BMI|12, 24, 36, 48 and 60 months|||||||
2635187|NCT01806740|Secondary|Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Time to Progression|"To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and time to progression.~The time to progression was calculated from the patient's survival status and tumor progression status recorded one year after initiation of the sorafenib treatment.~The correlation analyses were done using Pearson or Spearman correlation coefficient."|1 year|Among the 15 patients of the full analysis set (26 target lesions), 4 patients had data for time to progression (7 target lesions).|||correlation coefficient|Target lesions||Number
2635188|NCT01806740|Secondary|Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Progression Free Survival|"To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and progression free survival.~The progression free survival was calculated from the patient's survival status and tumor progression status recorded one year after initiation of the sorafenib treatment.~The correlation analyses were done using Pearson or Spearman correlation coefficient."|1 year|Among the 15 patients of the full analysis set (26 target lesions), 13 had data for progression free survival (22 target lesions). One lesion was not assessed for Ktrans, ve and kep.|||correlation coefficient|Target lesions||Number
2635189|NCT01806740|Secondary|Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Overall Survival|"To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and overall survival.~The overall survival was calculated from the patient's survival status recorded one year after initiation of the sorafenib treatment.~The correlation analyses were done using Pearson or Spearman correlation coefficient."|1 year|Among the 15 patients of the full analysis set (26 target lesions), one patient was lost to follow-up. Consequently, 14 patients had data for overall survival (23 target lesions). One lesion was not assessed for Ktrans, ve and kep.|||correlation coefficient|Target lesions||Number
2635190|NCT01806740|Primary|Correlation Coefficient Between DCE-MRI Perfusion Parameters and the Response of Target Lesions to Sorafenib|"To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, Wash-in, Washout) at baseline, week 1 and week 2, and the response of target lesions to sorafenib.~Ktrans: volume transfer constant between blood plasma and extravascular extracellular space~AUC : area under the curve of tissue gadolinium concentration-time~ve: fractional volume of extravascular extracellular space~kep: rate constant between extravascular extracellular space and blood plasma (=Ktrans/ve)~T1: longitudinal relaxation time~Wash-in: slope of the early enhancement curve~Washout: slope of the late enhancement curve~The response of target lesions was assessed by mRECIST at 2 months after initiation of treatment (sorafenib).~The correlation analyses were done using Pearson or Spearman correlation coefficient."|3 months|A total of 26 target lesions were identified in the 15 patients of the full analysis set (patients with available data for the primary criteria). One lesion was not assessed at baseline, week 1 and week 2 for all parameters and one lesion was not assessed at baseline and week 1 for Ktrans, ve and kep.|||correlation coefficient|Target lesions||Number
2635191|NCT01806714|Secondary|Percentage of Participants Receiving HPV Vaccination (Dose 3)|Participants who received HPV vaccine dose 3 at end of study period Kaplan-Meier failure function|9 months|Only subjects with valid phone numbers were included and not all recipients got the 2nd dose. Only subjects who got the 2nd dose were then given the 3rd dose and only if they had working phone numbers.|||percentage of eligible participants|||Number
2635192|NCT01806714|Secondary|Percentage of Participants Receiving HPV Vaccination (Dose 2)|Participants who received HPV vaccine dose 2 at end of study period Kaplan-Meier failure function|9 months|Only subjects with a valid phone number at the time dose 2 was dispensed received the vaccine. The number of subjects receiving dose 2 is higher than dose 1 because some phones numbers that were inactive during dose 1 were active during dose 2.|||percentage of eligible participants|||Number
2635193|NCT01806714|Primary|Percentage of Participants Receiving HPV Vaccination (Dose 1)|Participants who received HPV vaccine dose 1 Kaplan-Meier failure function|9 months|Only subjects with valid phone numbers at the time dose 1 was dispensed received dose 1.|||percentage of eligible participants|||Number
2635194|NCT01806675|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as remaining alive at 1 year with disease progression, according to the physician's assessment of clinical status, by disease group.|1 year|Data was not collected for progression-free survival (PFS).||||||
2635195|NCT01806675|Secondary|Tumor Response Rate by EORTC Criteria|"Tumor Response Rate by EORTC Criteria Tumor response rates were assessed from position emission tomography (PET) scans using 18F-FPPRGD2 & 18F-FDG at baseline & after 6 weeks of treatment, per European Organization for Research & Treatment of Cancer (EORTC) response criteria. The outcome is reported for each radiotracer by disease group as the number of participants achieving complete response (CR), partial response (PR), stable disease (SD), & progressive disease (PD).~CR= complete resolution of 18F-FDG uptake tumor volume~PR= reduction of 15-25% in tumor 18F-FDG SUVmax after 1 cycle of chemotherapy, and ≥25% after >1 cycle~SD= increase in tumor 18F-FDG SUVmax of <25% or a decrease of <15% & no increase in 18F-FDG tumor uptake [>20% in the longest dimension (LD)];~PD= increase in 18F-FDG tumor SUVmax of >25% in tumor region on baseline; increase in extent of 18F-FDG tumor uptake (>20% in LD); appearance of new 18F-FDG uptake in metastatic lesions"|At baseline and 6 weeks|This assessment was restricted to gynecological cancers and renal cell carcinoma participants only. Tumor response data was not available for all participants in these groups.|||participants|||Number
2635196|NCT01806675|Secondary|Change in Tumor Size|The treatment effect for participants with gynecological cancers (GYN) and renal cell carcinoma (RCC) was assessed on the basis of change in tumor size as determined by pre- and post-treatment CT scans. The outcome is reported as the difference at treatment follow-up, reported as the median with standard deviation.|9 to 12 weeks|This assessment was restricted to gynecological cancers and renal cell carcinoma participants only. Tumor response data was not available for all participants in these groups.|||centimeters||Standard Deviation|Median
2635232|NCT01806571|Secondary|Disease Free Survival(DFS) Rate|Disease free survival time is defined for all evaluable patients who have achieved a CR or CRi as the time from registration to relapse or death due to any cause. The distribution of disease-free survival will be estimated using the method of Kaplan-Meier. In addition, the diseasefree survival rate at 2 years after registration will be reported.|2 years||||percentage of patients||95% Confidence Interval|Number
2637129|NCT01784848|Secondary|Absolute Change From Baseline on Weight Loss|Absolute change from baseline on weight loss|12, 24, 36, 48 and 60 months|||||||
2635197|NCT01806675|Secondary|Response Assessment by RANO Criteria|"The treatment effect for participants with glioblastoma multiforme was to be assessed on the basis of post-treatment evaluation per the Response Assessment in Neuro-Oncology (RANO) Criteria. The outcome was the number & proportion of participants that achieved either a complete response (CR) or partial response (PR), a number without dispersion. RANO criteria are:~CR= No T1 gadolinium (T1-G); T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR) stable/decreased, no new lesions; no corticosteroids; clinical condition improved/stable.~PR= ≥50% decrease in T1-G; T2/FLAIR decreased/stable ; no new lesions; decreased/stable corticosteroids; clinical condition improved/stable.~Stable disease (SD)= <50% decrease, but more than 25% increase, in T1-G; T2/FLAIR decreased/stable; no new lesions; decreased/stable corticosteroids; clinical condition improved/stable.~Progressive disease (PD)= ≥25%increase T1-G; T2/FLAIR increased; increased corticosteroids; clinical condition decreased"|At baseline and 6 weeks|This assessment was restricted to glioblastoma multiforme (GBM) participants only, however, no response assessments were obtained for GBM participants.||||||
2635198|NCT01806675|Primary|Change From Baseline in Maximum Standard Uptake Values (SUVmax)|Maximum standard uptake values (SUVmax) were assessed on the basis of position emission tomography (PET) scans using radiotracers 18F-FPPRGD2 and 18F-FDG at baseline and at regular medical care follow-up (6 to 12 weeks after initiation of treatment). The outcome is assessed as the difference in the maximum standard uptake values (SUVmax) values from baseline to follow-up for the 2 radiotracers, and will be reported for each disease type as the median with standard deviation.|At baseline and 6 weeks|Some participants did not contribute some or all post-treatment scans.|||ratio||Standard Deviation|Median
2635199|NCT01806662|Primary|Proportion of SCORAD-50 Response at Week 16.|"Greater improvement from their baseline objective SCORAD (SCORing Atopic Dermatitis) at Week 16. The efficacy variable for each randomized group is the proportion of subjects who achieve an improvement of 50% or greater from their baseline objective SCORAD at Week 16 (at crossover). SCORAD-50 is the percentage of decrease in baseline SCOARD at Week 16.~SCORAD is a clinical tool used to assess the extent and severity of eczema. Calculation is based on extent of involvement (skin involvement) and subjective symptoms of itching and loss of sleep. The SCORAD scale ranges from 0 (minimum, lowest possible score, Mild severity) to 103 (maximum, highest possible score, Severe severity) [last observation carry forward]."|Week 16|Proportion of participants with improved outcome.|||Participants|||Count of Participants
2635200|NCT01806623|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid|Area under the concentration time-curve from zero to the last measured concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid|Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2635201|NCT01806623|Secondary|Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid||Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.|||hrs||Full Range|Median
2635202|NCT01806623|Secondary|Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Potassium in Vaginal Fluid||Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2635203|NCT01806623|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight|Area under the concentration time-curve from zero to the last measured concentration (AUClast) for Vaginal Fluid Fluconazole Concentration adjusted by Sample Weight|Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.|||mcg*h/g||Geometric Coefficient of Variation|Geometric Mean
2635204|NCT01806623|Secondary|Time to Reach Maximum Observed Concentration (Tmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight||Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.|||hours||Full Range|Median
2635205|NCT01806623|Secondary|Maximum Observed Concentration (Cmax) for Vaginal Fluid Fluconazole Concentration Adjusted by Sample Weight||Before dosing and 2, 24, 48 and 168 hours after dosing|The vaginal discharge parameter analysis set was defined as those participants who were included in the vaginal discharge concentration analysis set and for whom at least one set of vaginal discharge parameters was calculated.|||mcg/g||Geometric Coefficient of Variation|Geometric Mean
2635206|NCT01806623|Secondary|Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Before dosing and 2, 24, 48 and 168 hours after dosing|The plasma parameter analysis set was defined as those participants who were included in the plasma concentration analysis set and for whom at least one set of plasma concentration parameters was calculated.|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2635207|NCT01806623|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Before dosing and 2, 24, 48 and 168 hours after dosing|The plasma parameter analysis set was defined as those participants who were included in the plasma concentration analysis set and for whom at least one set of plasma concentration parameters was calculated.|||hours||Full Range|Median
2635208|NCT01806623|Secondary|Maximum Observed Plasma Concentration (Cmax)||Before dosing and 2, 24, 48 and 168 hours after dosing|The plasma parameter analysis set was defined as those participants who were included in the plasma concentration analysis set and for whom at least one set of plasma concentration parameters was calculated.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2635209|NCT01806623|Secondary|Total Scores for Clinical Symptoms|Sum of severity scores in vulvovaginal itching, vulvovaginal burning sensation, excoriation of vulva, vaginal discharge, vulva oedema, redness of vulva, vaginal redness, property of vaginal content. Higher scores show greater severity. Total Scores for Clinical Symptoms Severity range from 0 (best possible outcome) to 24 (worst possible outcome).|Day 1 (before dosing), Day 3, Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.|||score on s scale||Full Range|Mean
2635210|NCT01806623|Secondary|Mycological Efficacy: Eradication Rate|"Determined based on the results of culture of Candida as Eradication, Persistent or Indeterminate.~Eradication rate was calculated based on the following formula, the number of participants assessed as Eradication over total participants excluding ones assessed as Indeterminate multiplied by 100."|Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.|||percentage of participants||95% Confidence Interval|Number
2635211|NCT01806623|Secondary|Clinical Efficacy: Cure and Improvement Rate|"Scores of severity in signs and symptoms on each observation dates are compared with those before the treatment and the clinical efficacy is determined as Cure (the clinical symptom disappeared), Improvement (the clinical symptom was improved), Failure (the criteria for Cure and Improvement were not met, or other systemic antifungal drugs or local antifungal drugs were administered for the treatment of the disease to be examined) or Indeterminate (efficacy for each item was not determined for the reasons including failure to conduct the test, or other systemic antifungal agents or local antifungal drugs were administered for the treatment of infections other than the disease to be examined).~Cure and improvement rate was calculated based on the following formula, the number of participants assessed as Cure or Improvement over total participants excluding ones assessed as Indeterminate multiplied by 100."|Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.|||percentage of participants||95% Confidence Interval|Number
2635212|NCT01806623|Secondary|Clinical Efficacy: Cure Rate|"Scores of severity in signs and symptoms at each observation dates were compared with those before the treatment and the clinical efficacy was determined as Cure (the clinical symptom disappeared), Improvement (the clinical symptom was improved: the total score of clinical symptom was reduced relative to the total score before the treatment), Failure (the criteria for Cure and Improvement were not met, or other systemic antifungal drugs or local antifungal drugs were administered for the treatment of the disease to be examined) or Indeterminate (efficacy for each item was not determined for the reasons including failure to conduct the test, or other systemic antifungal agents or local antifungal drugs were administered for the treatment of infections other than the disease to be examined).~Cure rate was calculated based on the following formula, the number of participants assessed as Cure over total participants excluding ones assessed as Indeterminate multiplied by 100."|Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.|||percentage of participants||95% Confidence Interval|Number
2635213|NCT01806623|Primary|Therapeutic Outcome: Response Rate|"Therapeutic outcome was determined by combination of clinical efficacy and mycological efficacy for each participant as Effective, Ineffective or Indeterminate. The therapeutic outcome was considered as Effective when the clinical efficacy was Cure and the mycological efficacy was Eradication.~Primary evaluation of therapeutic outcome was on Day 28.~Response rate was calculated based on the following formula, the number of participants assessed as effective over total participants excluding ones assessed as indeterminate multiplied by 100."|Day 7, Day 14 and Day 28|The modified-Intent to Treat (m-ITT) included participants with vulvovaginal candidiasis who received the investigational products, who tested positive for Candida in the vulva and/or vagina at Day 1 (before dosing), and whose clinical efficacy was evaluated.|||percentage of participants||95% Confidence Interval|Number
2635214|NCT01806597|Secondary|Number of Participants Developing Anti-secukinumab Antibodies|To investigate the development of immunogenicity against secukinumab|Over time up to week 132|FAS|||Participants|||Count of Participants
2635215|NCT01806597|Secondary|Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score (Observed Cases) - Entire Treatment Set|Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).|Week 16, Week 32, Week 80, Week 132|FAS|||Units on a scale||Standard Deviation|Mean
2635216|NCT01806597|Secondary|Absolute Change From Baseline for Palmoplantar Psoriasis Area and Severity Index (ppPASI) Score -Treatment Period I|Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease).|Week 1, Week 2, Week 4, Week 8, Week 12, Week 16|FAS|||Units on a scale||Standard Deviation|Mean
2635217|NCT01806597|Secondary|Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Entire Treatment Period|"ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.~Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline)."|Week 16, Week 24, Week 28, Week 80|FAS|||Percentages of participants|||Number
2635233|NCT01806571|Primary|Proportion of Complete Responses (CR or CRi) During Induction Therapy|The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.|Up to 56 days||||proportion of participants|||Number
2637130|NCT01784848|Secondary|Absolute Change From Baseline on Diastolic Blood Pressure|Absolute change from baseline in diastolic blood pressure|12, 24, 36, 48 and 60 months|||||||
2635218|NCT01806597|Secondary|Percentages of Subjects With ppIGA 0 or 1 Response (Observed Cases) - Treatment Period II|"ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.~Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline)."|Week 16, Week 20, Week 28, Week 32, Week 64, Week 132|FAS|||Percentages of participants|||Number
2635219|NCT01806597|Secondary|Percentages of Participants With Palmoplantar Investigator Global Assessment (ppIGA) 0 or 1 Response - Treatment Period I|"ppIGA: Palmoplantar Ivestigator's Global Assessment. The IGA mod 2011 rating scale: The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.~Based on this scale, a patient was considered as an IGA 0 or 1 responder if they achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale at a given time point compared to their score at randomization (baseline)."|Week 1, week 2, week 4, week, 8, week 12, week 16|FAS|||Percentages of participants|||Number
2635220|NCT01806597|Primary|Percentages of Participants With Palmoplantar Investigator Global Assessmnet (ppIGA) 0 or 1 Response After 16 Weeks of Treatment|palmoplantar Investigator's Global Assessment (ppIGA) response after 16 weeks of treatment. To be considered a ppIGA responder at Week 16, a subject must have ppIGA of 0 or 1 at Week 16 and a reduction of at least 2 points on the ppIGA scale from baseline.|Week 16|Full Analysis Set (FAS): The FAS comprised of all patients from the randomized set to who study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization.|||Percentages of participants|||Number
2635221|NCT01806584|Secondary|Number of Interventions to Establish, Maintain, or Restore Patency|The total numbers of interventions to establish, maintain, or restore patency was assessed at the Week 26 visit.|26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data.|||interventions||Standard Deviation|Mean
2635222|NCT01806584|Secondary|Percentage of Participants With Loss of Secondary Patency|Secondary patency (access survival until abandonment) was defined as the duration of time in days from the date of randomization (AVG placement) until the date of access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject's AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site's standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access.|Up to 78 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data.|||percentage of participants|||Number
2635223|NCT01806584|Secondary|Percentage of Participants With Loss of Assisted Primary Patency|Assisted primary patency (thrombosis--free access survival) was defined as the duration of time in days from the date of randomization (AVG placement) until the first date of (a) occlusion (commonly due to thrombosis) or (b) access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject's AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site's standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access.|Up to 78 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data.|||percentage of participants|||Number
2635224|NCT01806584|Primary|Percentage of Participants With Loss of Unassisted Primary Patency|Unassisted primary patency (intervention--free access survival) was defined as the duration of time in days from the date of randomization (arteriovenous graft [AVG] placement) until the first date of (a) any intervention designed to establish, maintain, or restore patency, (b) occlusion (commonly due to thrombosis), or (c) access abandonment. Assessment of AVG patency was evaluated during physical examination of the subject's AVG at each visit and through ongoing AVG monitoring and surveillance according to each participating site's standard practice. It was recommended to follow the National Kidney Foundation Kidney guidelines (National Kidney Foundation 2006) on appropriate management and treatment of AVG complications to improve the function and longevity of the vascular access.|Up to 78 weeks after surgery|The Intent to-Treat (ITT) population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data.|||percentage of participants|||Number
2635225|NCT01806571|Other Pre-specified|MRD, Assessed by PCR or Flow Cytometry|MRD status will be correlated with response using Fisher's exact test. In addition, the relationship between MRD status (positive vs. negative) and disease-free survival will be evaluated using landmark analyses.|Up to 3 years|||||||
2635226|NCT01806571|Other Pre-specified|Bone Marrow Kit Mutation/Expression|Will be summarized and used to help characterize the types of patients accrued to this trial.|Baseline|||||||
2635227|NCT01806571|Other Pre-specified|Bone Marrow Kit Mutation Status||Up to 3 years|||||||
2635228|NCT01806571|Other Pre-specified|Bone Marrow Flt3 Mutation|Will be summarized and used to help characterize the types of patients accrued to this trial.|Baseline|||||||
2635229|NCT01806571|Secondary|Overall Survival(OS) Rate|Overall survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier(Kaplan E 1958). In addition, the overall survival rate at 2 years after registration will be reported.|At 2 years||||percentage of patients alive||95% Confidence Interval|Number
2635230|NCT01806571|Secondary|Incidence of Adverse Events as Assessed by NCI CTCAE Version 4.0|The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. This data will be reported in the Adverse Events section of the results.|Up to 3 years after completion of study treatment|All treated patients|||Participants|||Count of Participants
2635234|NCT01806545|Secondary|Number of Interventions to Establish, Maintain, or Restore Patency|The total number of interventions to establish, maintain, or restore patency was recorded for each participant.|12 and 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.|||interventions||Standard Deviation|Mean
2635235|NCT01806545|Secondary|Percentage of Participants With Clinical Success Based on First Use of The Study AVF For Hemodialysis|Clinical success was defined as the ability to undergo hemodialysis using the AVF. The date of clinical success corresponded to the date of the first use of the study AVF for hemodialysis as determined by the investigator, following discussion with the subject. Clinical success was assessed in a continuous fashion and, once achieved, the AVF was considered a clinical success at that and all subsequent time points. The date of clinical success based on the first use of the AVF for hemodialysis was compared with the dates of each study visit (Week 12 and Week 26); for study visits occurring prior to the date of clinical success based on the first use of the AVF for hemodialysis, the subject was counted as a nonsuccess and for study visits occurring on or after the date of maturation based on the first use of the AVF for hemodialysis, the subject was counted as a success.|12 and 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.|||percentage of participants|||Number
2635236|NCT01806545|Secondary|Change From Week 1 in Average Vascular Access Lumen Diameter Using CDUS|B-mode lumen diameter measurements were obtained in the outflow vein as 3 separate images for each location: at 1, 3, and 5 centimeter into the vein and from the toe of the venous anastomosis. The average of lumen diameter measurements obtained at 1, 3, and 5 cm from the anastomosis was used for this endpoint.|1, 12, and 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.|||millimeters||Standard Deviation|Mean
2635237|NCT01806545|Secondary|Percentage of Participants With Loss of Secondary Patency|The time to loss of secondary patency (access survival until abandonment) was defined as the duration of time in days from the date of randomization (AVF creation) until the date of access abandonment.|Up to 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.|||percentage of participants|||Number
2635238|NCT01806545|Secondary|Percentage of Participants With Loss of Assisted Primary Patency|The time to loss of assisted primary patency (thrombosis--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) occlusion (commonly due to thrombosis) or (b) access abandonment.|Up to 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.|||percentage of participants|||Number
2635239|NCT01806545|Secondary|Percentage of Participants With Loss of Unassisted Primary Patency|The time to loss of unassisted primary patency (intervention--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) any intervention designed to establish, maintain, or restore patency; (b) occlusion (commonly due to thrombosis); or (c) access abandonment.|Up to 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.|||percentage of participants|||Number
2635240|NCT01806545|Secondary|Time to AVF Maturation Based on Hemodialysis or CDUS and Vascular Access Examination|Time to AVF maturation was defined as the duration of time (in days) from the date of randomization (AVF creation) to the date of maturation, where the date of maturation corresponds to the earlier of either the date of the first use of the study AVF for hemodialysis as determined by the investigator following discussion with the participant, or the date the AVF meets all of the following 3 criteria as determined through CDUS and vascular access examination: presence of bruit throughout systole and diastole at least 8 centimeters proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Participants who died, underwent a kidney transplant, or were either lost to follow-up or did not mature during the study follow-up were censored at the time of death, time of transplant, or time of last visit, respectively.|Up to 26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.|||days||Inter-Quartile Range|Median
2635241|NCT01806545|Secondary|Percentage of Participants With AVF Maturation by Week 26 Visit Based on Hemodialysis or CDUS And Vascular Access Examination|Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 26 visit without assessment of maturity were considered treatment failures.|26 weeks after surgery|The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.|||percentage of participants|||Number
2635242|NCT01806545|Primary|Percentage of Participants With Arteriovenous Fistula (AVF) Maturation by Week 12 Visit Based on Hemodialysis or Color-flow Doppler Ultrasound (CDUS) And Vascular Access Examination|Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 12 visit without assessment of maturity were considered treatment failures.|12 weeks after surgery|The Intent- to-Treat (ITT) population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.|||percentage of participants|||Number
2635243|NCT01806506|Other Pre-specified|Pulmonary Function Changes at 12 Months|Spirometry and plethysmography results are used to assess pulmonary function before and after surgery.|Baseline and 12 months from surgery|||||||
2635244|NCT01806506|Other Pre-specified|Quality of Life Questionnaire Score|Quality of life questionnaire score at 12 months(WHO-Bref Quality of Life questionnaire)|12 months after surgery|||||||
2635254|NCT01806506|Secondary|Plasma Leptin at 12 Months|Leptin is one of the adipose-derived hormones that causes inhibition of appetite. Elevated leptin levels are associated with obesity, inflammation, metabolic syndrome and cardiovascular disease. Weight loss leads to a decline in leptin concentrations.|12 months after surgery|||||||
2635255|NCT01806506|Secondary|Plasma Ghrelin at 12 Months|Ghrelin is an appetite-stimulating hormone produced in the fundus of the stomach. Its concentration may change after some bariatric procedures.|12 months after surgery|||||||
2635256|NCT01806506|Secondary|Plasma Uric Acid at 12 Months|Hyperuricemia is associated with metabolic syndrome and obesity.|12 months after surgery|||||||
2635257|NCT01806506|Secondary|Plasma CRP at 12 Months|C-reactive protein (CRP) is used as a marker of inflammation. It may be also used in the assessment of heart disease risk.|12 months after surgery|||||||
2635258|NCT01806506|Secondary|HbA1c at 12 Months|The proportion of glycosylated hemoglobin (HbA1c) [%] is measured to assesses the average plasma glucose concentration and regulation.|12 months after surgery|||||||
2635259|NCT01806506|Secondary|HOMA Index at 12 Months|Insulin resistance (IR) measured with the homeostatic model assessment (HOMA) method. In the published studies the HOMA model correlated with estimates using the reference euglycemic clamp method. The following equation is used: HOMA-IR = (fasting plasma glucose concentration [mmol/L] x fasting plasma insulin concentration [miliunits/L])/22.5|12 months after surgery|||||||
2635260|NCT01806506|Secondary|Plasma C-peptide at 12 Months|Fasting plasma C-peptide concentration in patients 12 months after surgery.|12 months after surgery|||||||
2635261|NCT01806506|Secondary|Plasma Insulin at 12 Months|Fasting plasma insulin concentration in patients 12 months after surgery.|12 months after surgery|||||||
2635262|NCT01806506|Secondary|Plasma Glucose at 12 Months|Fasting plasma glucose concentration in patients 12 months after surgery.|12 months after surgery|||||||
2635263|NCT01806506|Secondary|Plasma Triglycerides at 12 Months|Fasting plasma triglycerides concentration in patients 12 months after surgery.|12 months after surgery|||||||
2635264|NCT01806506|Secondary|Plasma LDL at 12 Months|Fasting plasma low density lipoprotein (LDL) cholesterol concentration in patients 12 months after surgery.|12 months after surgery|||||||
2635265|NCT01806506|Secondary|Plasma HDL at 12 Months|Fasting plasma high density lipoprotein (HDL) cholesterol concentration in patients 12 months after surgery.|12 months after surgery|||||||
2635266|NCT01806506|Secondary|Plasma Total Cholesterol at 12 Months|Fasting plasma total cholesterol concentration in patients 12 months after surgery.|12 months after surgery|||||||
2635267|NCT01806506|Secondary|Change in BMI From Baseline|Assessment of Body Mass Index (weight divided by height in meters squared) change from baseline.|Baseline and 12 months after surgery|||||||
2635268|NCT01806506|Secondary|Change in Weight From Baseline|Absolute weight loss (in kilograms) is evaluated. It is one of the most commonly used and accepted outcome measures in clinical trials evaluating bariatric surgery. It is more dependent on the initial weight of a study participant.|Evaluation at baseline and 12 months after surgery|||||||
2635269|NCT01806506|Secondary|Comorbidities Prevalence Changes|Number of patients with comorbidities such as: type 2 diabetes mellitus, arterial hypertension, dyslipidemia, obstructive sleep apnea, degenerative arthritis, gallbladder disease, gastro-esophageal reflux disease.|Evaluation at baseline and 1, 6 and 12 months after surgery|||||||
2635270|NCT01806506|Secondary|Number of Patients With Complications|Complications are defined as any negative deviation from the normal postoperative course. Complications of bariatric surgery include but are not limited to: gastrointestinal leak, intrabdominal bleeding, gastrointestinal bleeding, gastrointestinal stricture, gastrointestinal fistula, marginal ulceration, internal hernia, bowel obstruction, deep vein thrombosis, pulmonary embolism, wound infection, seroma, fascial dehiscence, abdominal hernia, gallstone formation, dehydration, nutritional deficiencies|12 months after surgery|||||||
2635271|NCT01806506|Primary|Excess Weight Loss From Baseline|Weight loss measured as a percentage of excess weight lost is one of the most commonly used and accepted outcome measure in clinical trials evaluating bariatric surgery.|12 months after surgery||||percentage of EWL||Standard Deviation|Mean
2635272|NCT01806389|Primary|Infant Plasma Concentrations of Buprenorphine|Infant plasma concentrations of buprenoprhine obtained on day 14 of life|Day 14 of life||||ug/mL||Full Range|Median
2635273|NCT01806389|Primary|Maternal Breast Milk Concentrations of Buprenorphine|Breast milk will be obtained on these days at the time of peak plasma levels of buprenoprhine|Days 2,3,4,14 and 30 after delivery||||ug/mL||Full Range|Median
2635274|NCT01806389|Primary|Maternal Plasma Concentrations of Buprenorphine|Maternal plasma will be obtained at the time of peak buprenorphine levels on days 2,3,4,14 and 30|Days 2,3,4,14 and 30 after delivery||||ug/mL||Full Range|Median
2635275|NCT01806298|Other Pre-specified|Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation|An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are those events with onset dates occurring during the on-treatment period or if the worsening of an event is during the on-treatment period. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline up to Week 41|The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®.|||Participants|||Count of Participants
2635276|NCT01806298|Secondary|Treatment Adherence Rate as Documented Using EasypodTM Connect|Treatment adherence rate was measured by: (total dose received divided by total dose prescribed) multiplied by 100. Saizen solution for injection was administered using the easypod device and treatment adherence information was obtained from the device using the easypod connect software.|Week 2, 8, 16, 29 and 39|"The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®. Here, Number Analyzed signifies those subjects who were evaluable for the specified category at each time point."|||percentage of treatment adherence||Standard Deviation|Mean
2635277|NCT01806298|Secondary|Insulin-like Growth Factor-I Standard Deviation Score (IGF-I SDS)|Insulin-like Growth Factor-1 SDS was calculated based on the actual value of IGF-1 minus reference value of IGF-1 divided by reference standard deviation of IGF-1. SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) a subject's value was relative to the mean of the reference population. The scores were centered around zero. Negative score indicated that the IGF-I value was lower compared to the reference population.|Baseline, Week 2, 8, 16, 29, 39 and 41|"The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®. Here, Number Analyzed signifies those subjects who were evaluable for the specified category at each time point."|||Standard deviation score||Standard Deviation|Mean
2635278|NCT01806298|Secondary|Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels|Growth Hormone (GH) biomarker levels were summarized by GH treatment status at study entry (that is subjects were classified as GH treatment-naïve subjects or subjects with prior GH treatment for adult growth hormone deficiency [AGHD])|Baseline, Week 2, 8, 16, 29, 39 and 41|"The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®. Here, Number Analyzed signifies those subjects who were evaluable for the specified category at each time point."|||milligram/liter (mg/L)||Standard Deviation|Mean
2635279|NCT01806298|Secondary|Insulin-like Growth Factor-I (IGF-I) Levels|Growth Hormone (GH) biomarker levels were summarized by GH treatment status at study entry (that is subjects were classified as GH treatment-naïve subjects or subjects with prior GH treatment for adult growth hormone deficiency [AGHD]).|Baseline, Week 2, 8, 16, 29, 39 and 41|The safety analysis set included all treated subjects who had received at least 1 administration of Saizen®. Here, “Number Analyzed” signifies those subjects who were evaluable for the specified category at each time point.|||nanomoles per liter (nmol/L)||Standard Deviation|Mean
2635280|NCT01806298|Secondary|Percentage of Subjects With Binding Antibodies (BAbs) Who Became Positive for Neutralizing Antibodies (NAbs)|Percentage of subjects with BAbs who become positive for NAbs = (Number of NAb positive subjects / Number of BAbs positive subjects) x 100|Baseline up to Week 39|Data could not be analyzed as there were no subjects who were BAb positive.||||||
2635281|NCT01806298|Primary|Percentage of Subjects Developing Binding Antibodies (BAbs) to Saizen®|Percentage of subjects developing BAbs = (Number of BAb positive subjects / Total number of subjects) x 100.|Baseline up to Week 39|The modified Intent-To-Treat (mITT) analysis set included all treated subjects who had received at least 1 administration of Saizen® and had at least 1 post-baseline BAbs assessment.|||percentage of subjects||95% Confidence Interval|Number
2635282|NCT01806259|Other Pre-specified|Overall Survival|2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of death from any cause assessed up to 5 years)|5 years||||Participants|||Count of Participants
2635283|NCT01806259|Primary|Recurrence-free Survival|2 years for the primary analysis + 3 additional years for secondary analysis (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)|5 years||||Participants|||Count of Participants
2635284|NCT01806051|Primary|Changes in Plasma Phe and Tyrosine Levels|To evaluate the patterns of change in plasma Phe and tyrosine levels between the Baseline visit and 4 week visit for each arm.|Baseline and 4 weeks|Participants withdrew before any data were collected.||||||
2635285|NCT01805895|Secondary|Safety Assessment|Adverse events will be asses for 90 days. This will serve as our safety endpoint.|90 days||||adverse events|||Number
2635286|NCT01805895|Primary|Modified Rankin Scale|A blinded assessor will perform the modified Rankin Scale (this is the full scale name) after 90 days. This will serve as our efficacy endpoint. The scale measures function. It ranges from 0 to 6 with zero reflecting no disability, 1 to 5 increasing degrees of disability and 6 death. Lower numbers reflect preferred outcome. There are no sub scales.|90 days||||units on a scale||Standard Deviation|Mean
2635287|NCT01805882|Primary|The Proportion of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs|The primary outcome was the proportion of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than 43 IU/mL - the lower limit of quantification.|12 weeks after stop of treatment|Subjects who received treatment drugs per arm as listed in the Outcome Measure Description|||percentage of subjects||95% Confidence Interval|Number
2635288|NCT01805791|Secondary|The Proportion of Subjects With Mucosal Healing at Week 8|Mucosal healing was defined as having normal or inactive disease using a modified Mayo Score to determine if the decrease in the modified Mayo endoscopy sub-score from baseline was ≥1 in at least 1 segment and had an absolute score ≤1 in all segments.|8 weeks|Analysis included only those subjects who were randomized on or prior to 16 Jun 2014 and had an opportunity to complete the 8 week treatment period. Worst case imputation imputed any missing Week 8 value as a failure.|||Participants|||Count of Participants
2635289|NCT01805791|Secondary|The Proportion of Subjects With Clinical Response at Week 8|Clinical response was defined as a decrease in a modified Mayo Score from baseline by ≥3 points and ≥30% decrease in the modified Mayo Score, along with either a decrease in the rectal bleeding score ≥1 or an absolute rectal bleeding score ≤1.|8 weeks|Analysis included only those subjects who were randomized on or prior to 16 Jun 2014 and had an opportunity to complete the 8 week treatment period. Worst case imputation imputed any missing Week 8 value as a failure.|||Participants|||Count of Participants
2635290|NCT01805791|Primary|Percentage of Subjects With a Clinical Remission at Week 8|Clinical remission was defined as a total Mayo Score of ≤2 points with no individual sub-score >1 point and rectal bleeding score = 0.|8 weeks|Analysis included only those subjects who were randomized on or prior to 16 Jun 2014 and had an opportunity to complete the 8 week treatment period. Worst case imputation imputed any missing Week 8 value as a failure.|||Participants|||Count of Participants
2635291|NCT01805687|Secondary|Number of Subjects With Adverse Events||72 Hours|||||||
2635292|NCT01805687|Secondary|Area Under the Curve (AUC)||72 Hours|||||||
2635293|NCT01805687|Primary|Change From Baseline in FEV1||12 Hours||||Liter||Standard Deviation|Mean
2635311|NCT01805180|Secondary|Characterization of Blood Product - PMN Cell Yield|Characterization of the collected blood product, specifically total PMN cell yield. This is a measurement of device performance measured by calculating cell counts in samples from the collected blood product.|within 5 minutes after each collection procedure||||cells *10^10||Standard Deviation|Mean
2635294|NCT01805440|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|"The Columbia-Suicide Severity Rating Scale (C-SSRS) is used to measure suicidal thoughts and behaviors in Investigational New Drug (IND) studies. The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from wish to be dead to active suicidal ideation with specific plan and intent. The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent)."|6 weeks||||Scores on a Scale||Standard Deviation|Mean
2635295|NCT01805440|Primary|Change in Children's Depression Rating Scale-Revised (CDRS-R) Score.|The CDRS-R is a brief rating scale based on a semi-structured interview with the participant (and/or their parent or guardian). The scale can be administered and scored in under 30 minutes. The CDRS-R gives you a single summary score -- with an interpretation of, and clinical recommendations for, six different score ranges. Total possible scores range from 17 to 113, with higher scores indicating more depressive symptoms reported by the participant (and/or their parent or guardian).|6 weeks||||Units on a scale||Full Range|Mean
2635296|NCT01805440|Primary|Change in GLX (Glutamate + Glutamine) to Creatine (Cr) Ratio in the Anterior Cingulate Cortex of the Brain, as Measured With Proton-1 Magnetic Resonance Spectroscopy (1H-MRS).|Magnetic Resonance Spectroscopy is a safe, non-invasive method for measuring brain chemicals thought to be involved in mood disorders, such as GLX (glutamate + glutamine). Previous research indicates that adolescents with bipolar depression have elevated Glx concentrations, compared with controls. The measurement of Glx with 1H-MRS has the potential to identify translational biomarkers of juvenile BD pathophysiology and treatment response.|Baseline and 6 weeks||||Brain GLX/Cr||Standard Deviation|Mean
2635297|NCT01805323|Secondary|Peak Mean Change From Baseline in Central Retinal Thickness (CRT)|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye. The peak mean change was the maximum change from Baseline in CRT at 2 to 26 weeks following the last available injection of OZURDEX®. A negative change from Baseline indicated improvement.|Baseline, 2 to 26 weeks following last injection (up to 6.5 months)|All participants with CRT observations available following the last OZURDEX® injection from 2 to 26 weeks.|||microns (μm)|Eyes|Standard Error|Mean
2635298|NCT01805323|Primary|Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The peak mean change in BCVA was calculated using the most improved number of lines read correctly between 2 and 26 weeks following the last available injection of OZURDEX® - the number of lines read correctly at Baseline. A positive change from Baseline indicated improvement.|Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months)|All participants with BCVA observations available following the last OZURDEX® injection from 2 to 26 weeks.|||Lines|Eyes|Standard Error|Mean
2635299|NCT01805297|Secondary|Changes in Mean Central Retinal Thickness.|The amount of thickness change in microns from baseline to 6 month visit. A positive number indicates an increase in thickness and a negative number would indicate a decrease in thickness.|24 weeks|Due to lack of clear view due to vitreous Hemorrhage, all but 2 patients were unable to have optical coherence tomography at baseline, and one these was lost to follow up. For this reason, data collected for the few patients who were able to have the test was not analyzed|||Microns|||Number
2635300|NCT01805297|Secondary|Need for Any Additional Surgical Intervention.||24 weeks||||Participants|||Count of Participants
2635301|NCT01805297|Secondary|Mean Change in Visual Acuity|"Change in visual acuity measured using Early Treatment of Diabetic Retinopathy Study visual acuity charts and letter score difference from baseline to 6 month. A greater number indicates a higher increase in vision from the baseline score. A negative number would indicate that vision decreased."|24 weeks|Patients who completed 24 week visit|||Number of letters Read||Full Range|Mean
2635302|NCT01805297|Primary|Rate of Resolved Post-operative Vitreous Hemorrhage.|Percentage of patients who had no vitreous hemorrhage before or at week 24|24 weeks||||Participants|||Count of Participants
2635303|NCT01805180|Secondary|Safety|"Serious adverse events (SAEs) and unanticipated (serious) adverse device/procedure- related events (UADEs), adverse events (AEs).~any clinically significant changes to Complete Blood Count with differential white cell count (CBCD) and any significant changes to vital signs (temperature, heart rate, blood pressure) were captured as AEs. Also provided in full report to FDA."|48-hours after last procedure||||events|||Number
2635304|NCT01805180|Secondary|Usability/Assessment of System Operation - Device Malfunctions||Result know immediately upon successful completion of procedure||||events|||Number
2635305|NCT01805180|Secondary|Usability/Assessment of System Operation - Adjustments|Number of operator adjustments aimed at establishing and maintaining the plasma/ cellular interface: namely, on Spectra Optia, the adjustment of collection preference and, on COBE Spectra, the adjustment of the plasma pump flow rate.|Adjustments known immediately upon completion of the procedure||||number of adjustments||Standard Deviation|Mean
2635306|NCT01805180|Secondary|Usability/Assessment of System Operation - Time|Procedure time for collections on the Spectra Optia vs. the COBE Spectra.|Result captured immediately upon completion of procedure||||minutes||Standard Deviation|Mean
2635307|NCT01805180|Secondary|Characterization of the Blood Product - Volume|Characterization of the collected blood product, specifically product volume.|within 5 minutes after collection procedure||||mL||Standard Deviation|Mean
2635308|NCT01805180|Secondary|Characterization of the Blood Product - RBC Contamination|Characterization of the collected blood product, specifically red blood cell (RBC) contamination as measured by hematocrit in the collected PMN product.|within 5 minutes after collection procedure||||RBC percent of product volume||Standard Deviation|Mean
2635309|NCT01805180|Secondary|Characterization of the Blood Product - PMN Cell Viability|Characterization of the collected blood product, specifically PMN cell viability measured by an assay preformed on the collected blood product.|within 5 minutes after collection procedure||||percent of viable cells||Standard Deviation|Mean
2635310|NCT01805180|Secondary|Characterization of Blood Product - PMN Cell Yield Per Liter of Blood Processed|Characterization of the collected blood product, specifically PMN cell yield per liter blood processed. This is a measurement of device performance measured by calculating cell counts in samples from the collected blood product and blood processed measured by the device.|within 5 minutes after each collection procedure||||cells *10^10 per L of blood processed||Standard Deviation|Mean
2635312|NCT01805180|Secondary|Performance|Comparison of collection efficiencies associated with the Granulocyte Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for white blood cells and platelets. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure.|within 1 hour prior and within 5 minutes after each collection procedure||||percent of cells processed||Standard Deviation|Mean
2635313|NCT01805180|Primary|Granulocyte/PMN Cell Collection Efficiency|The primary endpoint is the granulocyte/PMN cell collection efficiency (CE) associated with the Granulocyte (PMN) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the PMN collection procedure.|within 1 hour prior and within 5 minutes after each collection procedure||||percent cells processed||Standard Deviation|Mean
2635314|NCT01805154|Primary|Number of Subjects Who Had an Improvement in NYHA Class Between Six Months and 12 Months|Improvement in NYHA Class determined by improvement by at least 1 class.|Between 6 and 12 months|Only subjects who had evaluable data at 6 and 12 months are included. Thus, fewer subjects than those who completed the 6-month and 12-month visits were analyzable.|||Participants|||Count of Participants
2635315|NCT01805154|Primary|Number of Subjects That Received Treatment Strategies for Heart Failure in the CRT Non-responder Population Between 6 and 12 Months||Between 6 and 12 months|The analysis population included any subject with a completed 6-month CRT evaluation. Subjects who withdrew prior to the 6-month visit, did not complete the 6-month visit or had relevant 6-month data missing were excluded from the analysis.|||Participants|||Count of Participants
2635316|NCT01805154|Primary|Number of Subjects With Specfic Types of Symptom-based and Objective Definitions Used by Sites to Determine Patients' Response to CRT|Number of subjects where sites used echocardiographic remodeling, clinical functional assessments, or clinical events to determine response status.|6 months|The analysis population included any subject with a completed 6-month CRT evaluation. Subjects who withdrew prior to the 6-month visit, did not complete the 6-month visit or had relevant 6-month data missing were excluded from the analysis.|||Participants|||Count of Participants
2635317|NCT01805154|Primary|Number of CRT Non-responders Using 1) Clinical Composite Score (CCS) and 2) Site-specific Criteria for Determining CRT Response|"The CCS has 4 components: New York Heart Association (NYHA) functional classification, Patient Global Assessment (PGA), heart failure (HF) events, cardiovascular death. NYHA Class ranges from Class I (least severe) to Class IV (most severe); possible PGA responses are markedly worse, moderately worse, slightly worse, no change, slightly better, moderately better, markedly better. CCS components were used to classify or score subjects as IMPROVED (at least one-class improvement in NYHA Class or improvement by PGA moderately or markedly better AND no HF events AND no cardiovascular death), or WORSENED (worsening in NYHA Class OR worsening by PGA moderately or markedly worse OR presence of HF events OR Cardiovascular death, or UNCHANGED (neither improved or worsened). Note CCS is not a numeric score.~Sites used their own clinical criteria (could include hospitalizations, functional assessments, etc.)"|6 months|The analysis population included any subject who had a 6-month CRT evaluation or died due to a cardiovascular cause prior to 6 months. Subjects who withdrew prior to the 6-month visit, did not complete the 6-month visit or had relevant 6-month data missing were excluded from the analysis.|||Participants|||Count of Participants
2635318|NCT01805089|Secondary|Change in Mood, Sleep Quality and Menopausal Symptoms From Baseline to 4 Months|Mood was assessed by the Center for Epidemiologic studies Depression Scale. The scale measures depressive symptoms in 20 items. Each question has a 4 point answer (0-3) so the scale range is 0-60. A higher score indicates more depression. Sleep quality was assessed by the Pittsburgh Sleep Quality Index. There are 19 questions each with a 3 point answer. The questions are grouped into 7 subscales and each has a value from 0-3. The 7 subscales are then added together to yield a global score with a range of 0-21. Higher scores indicate worse sleep. Menopausal symptoms were assessed by NCCTG Hot Flash diary. Subjects track the number and severity of hot flashes daily for 1 week. Subjects grade the severity of the hot flashes on a scale of 1-4, with 1 being mild and 4 very severe. Frequency and the severity determine the score . The minimum score is 0 (no hot flashes) and there is no maximum score. A higher score indicates more severe hot flashes. There are no subscales or no units.|baseline and 4 months||||change in PSQI score||Standard Deviation|Mean
2635319|NCT01805089|Primary|Compliance|To evaluate compliance with a 4 month course of melatonin. Compliance was assessed via pill counts.|4 months||||participants|||Number
2635320|NCT01805089|Primary|Absolute Plasma Estradiol Levels After 4 Month Course of Melatonin or Placebo|Absolute plasma estradiol levels after 4 month course of melatonin or placebo, only 4 month level provided below.|4 months||||pg/ml||Standard Deviation|Mean
2635321|NCT01805024|Secondary|Summary of All Treatment-emergent Adverse Events (TEAEs)|TEAEs reported during the treatment period|12 weeks||||number of events|||Number
2635322|NCT01805024|Primary|Pharmacokinetic Profile of Omigapil Area Under the Plasma Concentration Versus Time Curve From Time Zero to 8h Post-dose (AUC0-8)||0 to 8 hours post-dose on Day 1, Week 4, Week 12||||mg.h/ml||Geometric Coefficient of Variation|Geometric Mean
2635323|NCT01805024|Primary|Pharmacokinetic Profile of Omigapil: Time at Which Cmax Was Apparent (Tmax) of Omigapil||0.5, 1, 1.5, 2, 4 and 8 hours post-dose on Day 1, Week 4 and Week 12||||h||Geometric Coefficient of Variation|Geometric Mean
2635324|NCT01805024|Primary|Pharmacokinetic Profile of Omigapil:Maximum Observed Plasma Concentration (Cmax) of Omigapil||0.5, 1, 1.5, 2, 4 and 8 hours post-dose on Day 1, Week 4 and Week 12||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2635325|NCT01804946|Secondary|Percentage of Patients With Complications of the Influenza|Pneumonia, sinusitis, otitis media are examples of the influenza complications|Day 1 to Day 7|Per Protocol set|||Percentage of participants|||Number
2635326|NCT01804946|Secondary|Change in the Subjective Health Status|The patient subjective health status assessment was based on Visual Analogue Scale − VAS). VAS includes a rating of current health status from 0 (worst) to 100 (best).|Day 7 vs. Day 1|Per Protocol set|||Scores on a scale||Standard Deviation|Mean
2635374|NCT01804075|Primary|Days of Treatment With Opioid Medication|The length of time in days that the treatment opioid was used on a measured taper to ameliorate withdrawal signs|From date of randomization until the date of last opioid dose or date of death from any cause, whichever came first, assessed up to 12 months||||days||Standard Deviation|Mean
2635327|NCT01804946|Secondary|Change in the Patient's Quality of Life.|The quality of life was assessed in influenza patients at baseline and at the end of the treatment period using the European Quality of Life Questionnaire (EQ5D) measuring the health status by five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression (each dimension is assessed by 1 to 3 point scale; the minimum score 5 points refers to the best status, 15 points refers to the worst status).|Day 7 vs. Day 1|Per Protocol set|||Scores on a scale||Standard Deviation|Mean
2635328|NCT01804946|Secondary|The Number of the Antipyretic Intake|A subject recorded the number of antipyretic intake in patient diary.|Day 1 to Day 5|Per Protocol set|||Number of Doses||Standard Deviation|Mean
2635329|NCT01804946|Secondary|Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms)|The severity of influenza symptoms was assessed during a physical examination at Day 1, 3 and 7; common (10 symptoms) and respiratory (5 symptoms) symptom's total score was assessed with using the point scale: 0=No symptom; 1=Mild symptom; 2=Moderate symptom ; 3=Severe symptom. The Common Symptoms total score ranged from 0 (no symptoms) to 30 (severe symptoms). The Respiration Symptoms total score ranged from 0 (no symptoms) to 15 (severe symptoms)|on days 1, 3 and 7 of the observation|Per Protocol set|||Scores on a scale||Standard Deviation|Mean
2635330|NCT01804946|Secondary|Mean Body Temperature|The axillary temperature was assessed during a physical examination at Day 1, 3 and 7; axillary temperature was assessed in degrees (Celsius, °С)|on days 1, 3 and 7 of the observation|Per Protocol set|||°C||Standard Deviation|Mean
2635331|NCT01804946|Secondary|Time to Resolution of the Influenza|"Time to resolution was considered as time to the absence of any flu symptom. Absence of symptoms was considered as axillary temperature decline to or below 37.0 ºС without subsequent rise, resolution of the common and respiratory symptoms.~The duration of a symptom was defined by physician recorded presence/absence of the symptoms during a physical examination at Day 1 to Day 7."|Day 1 to Day 7|Per Protocol set|||Days||Standard Deviation|Mean
2635332|NCT01804946|Secondary|Percentage of Patients With Resolution of Influenza Symptoms|Assessment of the proportion of subjects with no clinical symptoms of the disease (fever, common and respiratory symptoms) at Study Day 7 (Visit 3). The severity of influenza symptoms was assessed by a physician with 0 to 3 point scale, where 0 means no symptom, 1=mild symptom, 2=moderate symptom, and 3=severe symptom|on the day 7 of the observation|Per Protocol set.|||Percentage of participants|||Number
2635333|NCT01804946|Primary|Percentage of Patients With Normal Body Temperature|Axillary temperature (morning and evening) decline to or below 37.0 ºС (without subsequent increase during ≥24 h)|Day 1 to Day 5|The Per Protocol (PP) set includes subjects received full per protocol therapy, completed all scheduled visits and had no substantial deviations from the protocol. Since PP-analysis and ITT-analysis demonstrated similar (confirmative) results the results of PP-analysis are presented.|||Percentage of participants|||Number
2635334|NCT01804881|Secondary|Change in Weight|Weight was recorded at baseline and after 6 weeks. There are fewer participants recorded in this secondary outcome measure (11 and 10 vs.13 and 12 in previous, main, outcome measure) because some participants did not want to be re-weighed.|6 weeks|Intention to Treat analysis|||kg||Standard Deviation|Mean
2635335|NCT01804881|Secondary|Change in Blood Pressure|Blood Pressure was recorded at baseline and after 6 weeks. There are fewer participants recorded in this secondary outcome measure (11 and 10 vs.13 and 12 in previous, main, outcome measure) because some participants did not want to have blood pressure taken again.|6 weeks|Intention to Treat analysis|||mm Hg||Standard Deviation|Mean
2635336|NCT01804881|Primary|The Change in EEQ (Emotional Eater Questionnaire) Score is the Primary Outcome Measure in This Study.|"The EEQ is a10-item validated questionnaire measuring the degree of interaction between food intake and emotion. Scores on a scale between baseline score and score after 6 weeks was measured.~The EEQ is scored as follows:~Values: Never = '0'; Sometimes = '1'; Generally = '2'; Always = '3' Score between 0-5: You are a non-emotional eater. Score between 6-10: You are a low emotional eater. Score between 11-20: You are an emotional eater. Score between 21-30: You are a very emotional eater. The participants completed the EEQ at baseline and it was scored. After 6 weeks the participants completed the EEQ again and it was scored again. The participants' baseline score was compared to the score at week 6. The goal was for scores to reduce. If participants' scores were higher at week 6, that could mean that the intervention was not successful. If the participants' scores were lower at week 6, that could mean that the intervention was successful."|6 weeks|Intention to Treat analysis|||Scores on a scale||Standard Deviation|Mean
2635337|NCT01804842|Primary|Rmax (0-24) of Plasma Glucose|Rmax (0-24) = maximum response from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.|Times points to determine Rmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.75, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 18.5, 19, 19.5, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population|||mg/dL||Standard Error|Least Squares Mean
2635338|NCT01804842|Primary|AUC (0-24) of Plasma Glucose|AUC (0-24) = Area under the curve from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.|Times points to create the AUC (0-24) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.75, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 18.5, 19, 19.5, 20, 21, 22, 23, and 24 hours relative to the time of the standardized dinner.|Evaluable Population|||mg*h/dL||Standard Error|Least Squares Mean
2635339|NCT01804842|Primary|Cmax of Plasma Metformin|Cmax = maximum response from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.|Times points to determine Cmax were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population|||ng/mL||Standard Error|Least Squares Mean
2635375|NCT01804062|Secondary|ME +/- 1 Breath Per Minute, Max-N Sensor|The software shall calculate respiration rate values via Max-N with a mean error of +/- 1 breath per minute relative to a capnography based reference.|up to 40 minutes of continuous monitoring||||BrPM||Standard Deviation|Mean
2637131|NCT01784848|Secondary|Absolute Change From Baseline on Systolic Blood Pressure|Absolute change from baseline in systolic blood pressure|12, 24, 36, 48 and 60 months|||||||
2635340|NCT01804842|Primary|AUC (0-24) of Plasma Metformin|AUC (0-24) = Area under the curve from the start time of the standardized dinner (0 h) to 24 hours after the standardized dinner. Study medication was administered at t = 0 hours for Treatments B and C and at t = 12 hours for Treatments A and C.|Times points to create the AUC (0-24) were: t = -0.08, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 11.92, 12.5, 13, 13.5, 14, 14.5, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 hours relative to the start time of the standardized dinner.|Evaluable Population|||ng*h/mL||Standard Error|Least Squares Mean
2635341|NCT01804816|Secondary|Change in Quality of Life (QOL)|Patients quality of life (QOL) was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, after 5 weeks of no treatment and just prior to acupuncture treatment, and after 5 weeks of acupuncture treatments. Scores reported here are the Quality of Life Scores, which range from 0 to 100. Higher numbers indicate a better quality of life.|Baseline, Week 7, Week 13||||score on a scale||Standard Deviation|Mean
2635342|NCT01804816|Primary|Change in 6-Minute Walk Distance||Baseline, Week 7, Week 13||||Feet||Standard Deviation|Mean
2635343|NCT01804816|Primary|Change in Cardiac Function: LVEF|Left ventricular ejection fraction (LVEF) percentage was measured at baseline, after 5 weeks of no treatment and just prior to acupuncture treatment, and after 5 weeks of acupuncture treatments.|Baseline, Week 7, Week 13||||LVEF Percentage||Standard Deviation|Mean
2635344|NCT01804673|Secondary|Post-Operative Phase (PPP33) Quality of Life Questionnaire Score|The PPP33 questionnaire has an overall score and 8 subscales that represent different aspects of the post-operative quality of life: information, autonomy, communication, physical complaints, pain, rest, fear and accommodation. Answers to individual question are scored with values 1 to 4. Summary scores are calculated by adding values for each question. Subscores ranges depend on the number of questions evaluated (2 to 7 questions). The overall score ranges from 1 to 100. Higher scores indicate less pain.|Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for the primary parameter after the 0 hour Baseline visit. 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||units on scale||Standard Deviation|Mean
2635345|NCT01804673|Secondary|Comprehensibility of the Information Material (IM): Participant Questionnaire Responses|Participants were asked to evaluate the IM for IONSYS by responding to following questions of a questionnaire: A- Is IONSYS easy to use, B- Were you able to operate the system by yourself after receiving instructions, C- Have you found button yourself, D- Was pressing button easy, E- Have you heard system's beeps, F- Was IONSYS IM easy to understand, G- Did IM help you to use system, H- Did you have problems falling asleep, I- Could you move easily in bed, J- Did system bother you during physiotherapy, K- Do you perceive use of such system as modern treatment standard.|Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit.|||percent of participants|||Number
2635346|NCT01804673|Secondary|Comprehensibility of the Information Material (IM): Nursing Staff Questionnaire Responses|Nursing staff were asked to evaluate the IM for IONSYS by responding to following questions of a questionnaire: IM A- Was IM easy to understand, B- Did IM help you to use system properly; IONSYS PCA A- Is system easy to handle, B- Did participant need help in using system, C- Do you feel confident using IONSYS; IV PCA- Are you experienced in using IV PCA; IONSYS PCA D- Could participant get mobilized sooner, E- Does participant move more, F- Is participant less afraid of moving, G- Were hospital logistics for IONSYS easier to handle.|Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit.|||percent of participants|||Number
2635347|NCT01804673|Secondary|Comprehensibility of the Information Material (IM): Physician Questionnaire Responses|Physicians were asked to evaluate the IM for fentanyl-ITS (IONSYS) by responding to following questions of a questionnaire: Part2 D- Would you use IONSYS again, E- Would you prefer IONSYS to intravenous patient controlled analgesia (IV PCA); Part3 A- Was IM easy to understand, B- Did IM help you to use system properly.|Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||percent of participants|||Number
2635348|NCT01804673|Secondary|Physician's Evaluation of Participant's Ability to Undergo Physiotherapy or Mobilization|Physicians were asked to rate the participant's ability to undergo physiotherapy or mobilization by responding to following questions of a questionnaire: Part 1 A- Does the surgical procedure performed allow the mobilization of the participant, C- Was the mobilization of the participant limited due to pain, D- Is the participant in a condition to undergo physiotherapy; Part 2 A- Was it possible to mobilize the participant sooner than with other pain therapies, B- Does the participant move more, C- Is the participant less afraid of moving. For Part 1-Question C, 'Partial' indicates that mobilization of participant was moderately limited due to pain.|Hours 24, 48 and 72|Efficacy analysis set included all participants who received the study treatmentat least once and who had efficacy data for primary parameter after 0 hour Baseline visit. ‘n’ signifies participants evaluable at specified time point for specified item.|||percent of participants|||Number
2635349|NCT01804673|Secondary|Percentage of Participants With Nursing Staff Global Assessment of Pain|Nursing Staff were asked to give their overall global assessment of pain therapy with study treatment using a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.|Hours 24, 48 and 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. ‘n’ signifies those participants evaluable for this measure at the specified time point.|||percent of participants||95% Confidence Interval|Number
2635350|NCT01804673|Secondary|Percentage of Participants With Physician Global Assessment of Pain|Physicians were asked to give their overall global assessment of pain therapy with study treatment using a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.|Hours 24, 48 and 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. ‘n’ signifies those participants evaluable for this measure at the specified time point.|||percent of participants||95% Confidence Interval|Number
2635351|NCT01804673|Secondary|Percentage of Participants With Global Assessment of Pain at Hour 48 and 72|Participants were asked to give their overall global assessment of pain therapy with study treatment using a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.|Hours 48 and 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point.|||percent of participants||95% Confidence Interval|Number
2635352|NCT01804673|Secondary|Time to Mobilization|Participants were asked to describe their time schedule for particular steps of mobilization by answering specific questions in the participant diary.|Baseline, Hours 24, 48 and 72|Data was not statistically summarized but reported in individual participant listing. Due to excessive missing data it was not possible to calculate valid results for the different stages of mobilization.||||||
2635353|NCT01804673|Secondary|Time Spent Out of the Bed Per Day by the Participant|Participants were asked to enter the time in hours spend out of bed during the last 24 hours in the participant diary.|Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point.|||minutes||Standard Deviation|Mean
2635354|NCT01804673|Secondary|Change From Baseline in Pain Intensity Rating at Hour 24, 48 and 72|Nursing staff asked the participants to rate their current pain intensity on 11-point NRS (range 0 to 10, 0= no pain; 10= strongest pain imaginable).|Baseline, Hour 24, 48 and 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point.|||units on scale||Standard Deviation|Mean
2635355|NCT01804673|Secondary|Number of Hours Per Day With Average Pain Intensity Less Than or Equal to 4|Number of hours per day with average pain intensity less than or equal to 4 was measured on a 11-point Numeric Rating Scale (NRS) (range 0 to 10, 0=no pain; 4=mild pain; 10=strongest pain imaginable). If the participant was sleeping at time of measurement, pain intensity was assumed to be less than or equal to 4.|Baseline to Hour 24, Hour 24 to Hour 48 and Hour 48 to Hour 72|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for the primary parameter after 0 hour Baseline visit. 'N' (number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies participants evaluable for this measure at specified time point.|||hours||Standard Deviation|Mean
2635356|NCT01804673|Primary|Percentage of Participants With Global Assessment of Pain at Hour 24|Participants were asked to rate their overall global assessment of pain therapy with study treatment on a 4-point verbal rating scale (poor, fair, good, excellent). Outcome of 'good' or 'excellent ' was recorded as Response while outcome of 'poor' or 'fair' was recorded as No response.|Hour 24|Efficacy analysis set included all participants who received the study treatment at least once and who had efficacy data for the primary parameter after the 0 hour Baseline visit.|||percent of participants||95% Confidence Interval|Number
2635357|NCT01804582|Secondary|Medication Regimen|We will utilize Medicaid pharmacy prescription data collect information at baseline and 90 days on the name and dose of all psychiatric medications prescribed at those time points. Participants were designated increase or no increase in their dosage of antipsychotic medication (i.e., dichotomous Yes/No) over the 90 day intervention period.|Change from Baseline to 90 days|The total n=229 included those on medication at 90 days (119 never filled the prescription or changed to a different med).|||Participants|||Count of Participants
2635358|NCT01804582|Secondary|Psychosocial Service Utilization|We will utilize total Medicaid claims data for any psychosocial services claims (e.g. individual, family, or group psychotherapy; parenting groups) to collect information on services used in the 90 days prior to the baseline and over the 90 days of participant enrollment in the study. Participants were considered to have received psychosocial claims (dichotomous Yes/No) if they received any individual, family, or group psychotherapy in the 90 days prior and during the study period. Higher numbers indicate more participants received at least 1 psychosocial service claim.|Change from Baseline to 90 days|The same participants 175 FN and 173 TAU participants were analyzed for psychosocial claims during the 90 day period prior to enrollment and then 90 days during enrollment. The count of participants represents the number of subjects (from the 175 FN and 173 TAU) that had at least 1 claim during each specified time period.|||Participants|||Count of Participants
2635359|NCT01804582|Secondary|Child Behavior Checklist - Brief Problem Monitor|We will use the preschool (ages 1 ½-5) and school age (6-12) versions of this measure, which asks parents to rate items about behavioral and emotional problems on a 0-2 scale. Both versions provide a Total Problem Score. These measures have been widely used in pediatric mental health research. The Brief Problem Monitor provides T scores for the total problem score and it ranges from 0-80, with higher T scores indicating more mental health difficulties. Subscales of this measure were not analyzed.|Change from Baseline to 90 days|An intent to treat analysis was conducted with a linear mixed model on all data collected at baseline and 3 months.|||units on a scale||Standard Deviation|Mean
2635360|NCT01804582|Primary|Youth Services Survey for Families|This 26-item questionnaire specifically targets parents' satisfaction with children's mental health services. The measure assesses five domains of parent satisfaction: cultural sensitivity, access, treatment participation, appropriateness, and outcome. This measure has been adopted by several State mental health systems to evaluate parent satisfaction with child services. A composite score was calculated for each participant with the range 1-5 (1 Strongly Disagree to 5 Strongly Agree) based on the average of their item scores. Range of scores is from 1-5 with higher scores indicating better functional social support. Subscales were not analyzed.|Change from Baseline to 90 days|An intent to treat analysis was conducted with a linear mixed model on all data collected at baseline and 3 months.|||units on a scale||Standard Deviation|Mean
2635436|NCT01803464|Primary|Bone Structure|Change in cortical bone volume of the middle third of the tibia from baseline to 6 months, as measured by MRI.|baseline to 6 months||||percent change||Standard Deviation|Mean
2635361|NCT01804582|Primary|Duke-UNC (University of North Carolina) Functional Social Support Questionnaire|"This 14 item questionnaire assesses confidant (e.g. I get chances to talk to someone I trust about family problems.), affective (People care what happens to me.), and instrumental (I can get help when I need transportation support.). In a validation sample, the measure was found to have good internal consistency and it correlated with related domains of psychosocial functioning in expected directions. This measure has been widely used to assess social support among both identified medical and mental health patients as well as their family members. A composite score was calculated for each participant with the range 1-5 (1 As much as I would like to 5 Much less than I would like) based on the average of their item scores. The range of scores is from 1-5 with lower scores indicating better functional social support. Subscales were not analyzed."|Change from Baseline to 90 days|An intent to treat analysis was conducted with a linear mixed model on all outcome data collected at baseline and 3 months to determine significance of change.|||units on a scale||Standard Deviation|Mean
2635362|NCT01804582|Primary|Family Empowerment Scale|This 34-item, Likert scale with scores ranging from 1 (never) to 5 (very often) which measures parent empowerment related to caring for their child with special needs. Higher scores indicate a greater sense of parental empowerment in caring for their child, interacting with the services system and contributing to the community. The sub scales have demonstrated good reliability and validity, and provide comprehensive information about empowerment, including attitudes, knowledge, and behaviors. A composite score was calculated for each participant with the range 1-5 (1 never to 5 very often)based on the average of their item scores with higher scores indicating better outcomes.|Change from baseline to 90 days|An intent to treat analysis was conducted with a linear mixed model which included data from all participants collected at baseline and 3 months.|||units on a scale||Standard Deviation|Mean
2635363|NCT01804257|Other Pre-specified|User Experience|Feedback and suggestions from patients, caregivers, and healthcare providers regarding system metrics and summary presentations of medication-taking, biometrics, and activities of daily living. Feedback includes free text and descriptive statistics summarizing numeric scores collected from a standardized instrument focusing on overall satisfaction with the DHFS and its components.|4 weeks|||||||
2635364|NCT01804257|Other Pre-specified|Usability|Characterize, using summary (descriptive) statistics, the use of the digital health feedback system and its components by patients, caregivers, and healthcare providers. Use captured utilizing numeric scores collected from a standardized instrument, focusing on overall comfort and ease of DHFS use.|4 weeks|||||||
2635365|NCT01804257|Other Pre-specified|Biometrics|Characterize, using summary (descriptive) statistics, heart rate and rest/activity patterns in a free-living environment. Activity defined as the number of hours per day with recorded a recorded step rate ≥ 60 steps per minute|4 weeks|||||||
2635366|NCT01804257|Other Pre-specified|Taking and Scheduling Adherence|Characterize, using summary (descriptive) statistics, medication-taking behavior in free-living environment. Taking adherence defined as the number of ingestion sensors detected by the DHFS in the free-living environment, divided by the prescribed (planned) number of ingestions. Scheduling adherence defined as number of ingestion sensors detected by the DHFS within a ± 2-hour time window around the prescribed (planned) dosing time, divided by the total number of ingestion sensors detected by the DHFS.|4 weeks|||||||
2635367|NCT01804257|Secondary|System Safety|Characterize, using summary (descriptive) statistics, the incidence and nature of system-related adverse events (AEs) and serious adverse events (SAEs) that are reported by study investigators over the course of the study|8 weeks|||||||
2635368|NCT01804257|Primary|Positive Detection Accuracy|Comparison of the detection rate of sensor-enabled placebo tablet ingestion using wireless observation (wirelessly observed therapy) to directly observed ingestion. Positive detection accuracy (PDA) for wirelessly observed therapy defined as the number of sensor ingestions detected by wireless observation, divided by the number confirmed ingestions using direct observation. PDA summarized as mean and 95% confidence interval.|4 weeks|28 individuals with bipolar disorder (12) or schizophrenia (16)|||percentage of observed ingestions||95% Confidence Interval|Mean
2635369|NCT01804140|Primary|Number of Participants Classified Based on Different Types of BRAF V600 Mutation Patterns in Tumor Samples|FFPEs tumor samples (at least 5 serially-cut, unstained, 5 μm sections) were collected from eligible participants who consented to participate in the study. FFPE tumor samples were either from archived sections (from the initial diagnosis of cancer) or from fresh biopsies that were performed according to local standards. Tumor samples were then sent to a central laboratory to identify activating BRAF V600 mutations. Identification of mutations was done using bidirectional direct Sanger sequencing procedure. V600E, V600K, V600D, and V600R are the different types of BRAF V600 mutations.|Up to 1 year|All the participants who were enrolled and were evaluable for the BRAF V600 mutations were included in the analysis.|||participants|||Number
2635370|NCT01804140|Primary|Percentage of Participants With BRAF V600 Mutation Positivity in Tumor Samples by Cancer Type|Formalin-fixed paraffin-embedded (FFPEs) tumor samples (at least 5 serially-cut, unstained, 5 micrometer [μm] sections) were collected from eligible participants who consented to participate in the study. FFPE tumor samples were either from archived sections (from the initial diagnosis of cancer) or from fresh biopsies that were performed according to local standards. Tumor samples were then sent to a central laboratory to identify activating BRAF V600 mutations. Identification of mutations was done using bidirectional direct Sanger sequencing procedure.|Up to 1 year|All the participants who were enrolled and were evaluable for the BRAF V600 mutations were included in the analysis. n is the number of participants with that type of cancer in the total population.|||percentage of participants||95% Confidence Interval|Number
2635371|NCT01804101|Secondary|Overall Remission Rate (CR+CRp)|Overall Remission Rate for the CR/CR with incomplete platelet count recovery (CRp) rate after up to 4 cycles of induction/re-induction therapy.|Up to day 28||||Participants|||Count of Participants
2635372|NCT01804101|Primary|Treatment-related Mortality Rate. (TRM)|Estimate whether the 32 units/m2 or the 64 units/m2 or both dose levels of CPX-351 are likely to improve treatment-related mortality (TRM) rate while keeping the CR rate constant in patients with untreated high-risk MDS or non-APL AML at high risk of TRM.|Up to 1 month after completion of study treatment||||Participants|||Count of Participants
2635373|NCT01804075|Secondary|Second Drug for Withdrawal|Number of infants treated with a second drug to treat their withdrawal|From date of randomization until the date of last opioid dose or date of death from any cause or date of discharge, whichever came first, assessed up to 12 months||||Participants|||Count of Participants
2635376|NCT01804062|Primary|Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor|The software shall calculate respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference.|up to 40 minutes of continous monitoring||||BrPM||Standard Deviation|Mean
2635377|NCT01804049|Secondary|Change in Muscle Characteristics|At baseline and 6 month follow-up visits, 32 subjects will undergo a muscle biopsy of the vastus lateralis muscle 15 cm above the patella using the modified Bergstrom technique under local anesthesia. The muscle biopsy specimens will be used for the histochemical and transcriptome analyses|6 months|Due to loss of sample and unmatched (time 0 and 6 month) sample availability as well as poor sample integrity, no interpretable histology data is available. No histology data was collected/analyzed from any samples for this Outcome measure.||||||
2635378|NCT01804049|Secondary|Change in Physical Performance - 400 Meter Walk Speed|At baseline, 1, 2, and 3 year follow-up visits, participants will have physical performance assessed using a 400 meter timed walk. We report the 400 meter timed walk speed as the change from baseline in seconds. The change in walk speed from baseline to the three year time point was used for analysis. For participants who withdrew from the study early, the walk speed from the final data point collected was used.|3 years||||seconds||Standard Deviation|Geometric Mean
2635379|NCT01804049|Primary|Change in Total Lean Mass From Baseline|At baseline, 1, 2, and 3 year follow-up visits, participants will have whole body dual x-ray absorptiometry scans (DXA) with a Hologic QDR 4500W DXA scanner by a certified DXA operator to determine total body lean mass and appendicular lean mass (Kg). The changes in appendicular and total lean mass were calculated by determining the change from baseline to the three year data point. If participants withdrew from the study prior to collection of 3 year data, the final time point available was used.|3 years|A simple adaptive randomization scheme was developed to balance gender, age and BMI. 120 subjects were randomized to treatment conditions according to 64% to 36% allocation probabilities. Subjects were followed for up to 3 years, with walk time and lean mass measured annually. The study experienced roughly 38% loss-to-follow up at year 3.|||grams lean mass||Standard Deviation|Geometric Mean
2635380|NCT01804036|Secondary|Mindfulness Assessment (Five-facet Mindfulness Questionnaire; FFMQ)|This is a validated questionnaire which tracks how facets of mindfulness may develop over time. It has 39 items and divides into 5 factors representing the various aspects of mindfulness. The range is 0-195. The greater the value the greater an individual's mindfulness level.|Baseline, 2 month follow up||||units on a scale||95% Confidence Interval|Mean
2635381|NCT01804036|Secondary|Connor-Davidson Resilience Scale (CD-RISC)|One of the few well-validated measures of resilience is the Connor-Davidson Resilience Scale (CD-RISC), comprising 25 items. All items are summed to obtain a CD-RISC total score ranging from 0-100, with greater total scores indicating greater resilience.|Baseline, 2 month follow up||||units on a scale||95% Confidence Interval|Mean
2635382|NCT01804036|Secondary|Center for Epidemiologic Studies Depression Scale (CES-D)|The CES-D is one of the most commonly validated screening tests for helping an individual to determine his or her depression quotient. The 20-item test measures depressive feelings and behaviors during the past week. Each item is summed to obtain a CES-D total score ranging from 0 to 60; higher scores indicate more severe depressive symptoms. A total score of 16 or higher was identified in early studies as indicative of individuals with depressive illness.|Baseline, 2 month follow up||||units on a scale||95% Confidence Interval|Mean
2635383|NCT01804036|Secondary|PTSD Check List (PCL) - Military (PCL-M)|The PCL-M is a well-validated 17-item self-report measure to assess PTSD severity among military personnel; both male and female, to assess military-related PTSD. Reliability evidence is very good. Items are based on DSM criteria (DSM-IV criteria for this version) and are rated on a 5-point Likert-type scale that allows the derivation of a quantifiable total score.Range is 0-85, the greater the value the worse the PTSD reported symptoms.|Baseline, 2 month follow up||||units on a scale||95% Confidence Interval|Mean
2635384|NCT01804036|Primary|Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 2 Month Follow-up|Sleep Diary - 7 days of data collection; Waking After Sleep Onset (WASO, in min.): The duration of awakenings throughout the night, calculated after falling asleep to before the last awakening of waking up and not going back to sleep. Range 0 - 24 hr. A negative value reflects improvement in WASO at the 2-month follow-up.|Baseline, 2 month follow up||||minutes||95% Confidence Interval|Mean
2635385|NCT01804036|Primary|Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 1-week Follow-up|Sleep Diary - 7 days of data collection; Waking After Sleep Onset (WASO, in min.): The duration of awakenings throughout the night, calculated after falling asleep to before the last awakening of waking up and not going back to sleep. Range 0 - 24 hr. A negative value reflects improvement in WASO at the 1-week follow-up.|Baseline, 1-week follow up||||minutes||95% Confidence Interval|Mean
2635386|NCT01804036|Primary|Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 2 Month Follow-up|Sleep Diary - 7 days of data collection; Sleep Onset Latency (SOL, in min.): The time to fall asleep, calculated from the time of turning out the light to falling asleep. Range 0 - 24 hr. A negative value reflects an improvement in SOL at the 2-month follow-up.|Baseline, 2 month follow up||||minutes||95% Confidence Interval|Mean
2635387|NCT01804036|Primary|Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 1-week Follow-up|Sleep Diary - 7 days of data collection; Sleep Onset Latency (SOL, in min.): The time to fall asleep, calculated from the time of turning out the light to falling asleep. Range 0 - 24 hr. A negative value reflects an improvement in SOL at the 1-week follow-up.|Baseline, 1-week follow up||||minutes||95% Confidence Interval|Mean
2635388|NCT01804036|Primary|Change in Total Sleep Time Using a Sleep Diary, From Baseline at 2 Month Follow-up|Sleep Diary - 7 days of data collection; Total Sleep Time (TST, in min.): The amount of time asleep, calculated from the time of falling asleep to waking up. Range 0 - 24 hr. The greater the value the more total sleep was obtained.|Baseline, 2 month follow up||||minutes||95% Confidence Interval|Mean
2635389|NCT01804036|Primary|Change in Total Sleep Time Using a Sleep Diary, From Baseline at 1-week Follow-up|Sleep Diary - 7 days of data collection. Total Sleep Time (TST, in min.): The amount of time asleep, calculated from the time of falling asleep to waking up. Range 0 - 24 hr. The greater the value the more total sleep was obtained.|Baseline, 1-week follow up||||minutes||95% Confidence Interval|Mean
2635437|NCT01803269|Secondary|Frequency of Reported Side Effects|Any adverse event regardless of grade or attribution|Up to 3 years after completion of study treatment||||Participants|||Count of Participants
2635390|NCT01804036|Primary|Change in Insomnia Severity Index, From Baseline at 2 Month Follow-up|Insomnia Severity Index - A 7-item validated questionnaire evaluating severity of insomnia symptoms over the past 7 days. The total score is reported with a range of 0-28. The greater the value the greater the insomnia severity. In the present study, the greater the change from baseline the greater the improvement in insomnia severity.|Baseline, 2 month follow up||||units on a scale||95% Confidence Interval|Mean
2635391|NCT01804036|Primary|Change in Insomnia Severity Index, From Baseline at 1-week Follow-up|Insomnia Severity Index - A 7-item validated questionnaire evaluating severity of insomnia symptoms over the past 7 days. The total score is reported with a range of 0-28. The greater the value the greater the insomnia severity. In the present study, the greater the change from baseline the greater the improvement in insomnia severity.|Baseline, 1-week follow up||||units on a scale||95% Confidence Interval|Mean
2635392|NCT01804036|Primary|Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 2 Month Follow-up|Medical Outcomes Study - sleep scale. A 12-item validated questionnaire evaluating sleep outcomes over the past 7 days. The subscale Sleep Problems Index - II, is reported, range is 0-100. The greater the value the worse the sleep problems. In the present study, the greater the change from baseline the greater the improvement in sleep problems.|Baseline, 2 month follow up||||units on a scale||95% Confidence Interval|Mean
2635393|NCT01804036|Primary|Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 1-week Follow-up|Medical Outcomes Study - sleep scale. A 12-item validated questionnaire evaluating sleep outcomes over the past 7 days. The subscale Sleep Problems Index - II, is reported, range is 0-100. The greater the value the worse the sleep problems. In the present study, the greater the change from baseline the greater the improvement in sleep problems.|Baseline, 1-week follow up||||units on a scale||95% Confidence Interval|Mean
2635394|NCT01803880|Secondary|Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments|"MRIs were obtained post-operatively at Day 10, obtained during the time period of Day 10 through Week 52, and again obtained during the time period of Week 52 through Week 104/ET). The images were evaluated using ICRS assessments of chondral lesions to determine the percentage of change in cartilage lesions over time post-operatively.~ICRS partial-thickness chondral lesion assessment scores:~Low-grade defect = less than 50% High-grade defect = 50% to 99%"|Postop Day 10, Day 10 to Week 52, Week 52 to Week 104/ET|Only Baseline subjects and subjects showing a percentage change in cartilage signal were included in the imaging results.|||units on a scale||Standard Deviation|Mean
2635395|NCT01803880|Secondary|Subject Satisfaction Postoperatively at Weeks 52 and 104|Subjects were questioned regarding their satisfaction with study treatment for knee pain.|Postop Weeks 52 and 104/ET|Not all participants completed the subject satisfaction questionnaire.|||Participants|||Count of Participants
2635396|NCT01803880|Secondary|Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)|"The EQ-5D-5L and EQ-VAS surveys were assessed at the specified time points. The EQ-5D-5L score was composed of 5 dimensions to assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on participant's responses.~The EQ-VAS score ranged from 0 to 100 with higher scores representing better health and lower scores representing worse health.~Summary total scores for EQ-VAS were calculated as:~Change in EQ-VAS score from Baseline at Week (x) or Day (x) = EQ-VAS score at Week (x) or Day (x) - EQ-VAS score at Baseline"|Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET|Not all participants completed the EQ-VAS questionnaire.|||score on a scale||Standard Deviation|Mean
2635397|NCT01803880|Secondary|Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)|"The EQ-5D-5L and EQ-VAS surveys were assessed at the specified time points. The EQ-5D-5L score was composed of 5 dimensions to assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on participant's responses. Each individual category calculated a score of between -1 and +1. A score of -1 showed the worst improvement and a score of +1 showed the most improvement.~Summary total scores for EQ-5D-5L were calculated as:~Change in EQ-5D-5L score from Baseline at Week (x) or Day (x) = EQ-5D-5L score at Week (x) or Day (x) - EQ-5D-5L score at Baseline"|Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET|Not all participants completed the EQ-5D-5L questionnaire.|||units on a scale||Standard Deviation|Mean
2635398|NCT01803880|Secondary|Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score|"SF-12 MCS scores at Baseline, post-operative visits (Weeks 6, 12, 24, 36, 52, and 104) and changes from Baseline were summarized descriptively by treatment group. The SF-12 health survey categories included: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. An ANCOVA model was used to compare the difference in the devices for change from Baseline in the SF-12 MCS scores at each of the scheduled post-operative visits. The model had change in SF-12 MCS score as the response variable and treatment, Baseline SF-12 MCS score, site, treatment-by-site interaction, lesion-grade and treatment-by-lesion grade interaction as independent variables.~Results were expressed as the MCS. Scores could range from 0 (the worst) to 100 (the best).~SF-12 scores for MCS were calculated as:~Change in SF-12 MCS score from Baseline at Week (x) = MCS score at Week (x) - MCS score at Baseline"|Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET|Not all participants completed the SF-12 questionnaire.|||score on a scale||Standard Deviation|Mean
2635399|NCT01803880|Secondary|Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score|"SF-12 PCS scores at Baseline, post-operative visits (Weeks 6, 12, 24, 36, 52 and 104) and changes from Baseline were summarized descriptively by treatment group. The SF-12 health survey categories included: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. An ANCOVA model was used to compare the difference in the devices for change from Baseline in the SF-12 PCS scores at each of the scheduled post-operative visits. The model had change in SF-12 PCS score as the response variable and treatment, Baseline SF-12 PCS score, site, treatment-by-site interaction, lesion-grade and treatment-by-lesion grade interaction as independent variables.~Results were expressed as the PCS. Scores could range from 0 (the worst) to 100 (the best).~SF-12 scores for PCS were calculated as:~Change in SF-12 PCS score from Baseline at Week (x) = PCS score at Week (x) - PCS score at Baseline"|Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET|Not all participants completed the SF-12 questionnaire.|||score on a scale||Standard Deviation|Mean
2635438|NCT01803269|Secondary|Overall Survival|Time from enrollment until death from any cause|Up to 3 years||||months||95% Confidence Interval|Median
2635400|NCT01803880|Secondary|Change in Visual Analog Scale (VAS) Scores From Baseline|"The VAS knee pain scores were assessed at Baseline, post-operative visits (Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET) and change from Baseline were summarized descriptively by treatment group. An ANCOVA model was used to compare the differences in the devices for change from Baseline in the VAS knee pain score at each of the scheduled post-operative visits. The model had change in VAS knee pain as the response variable and treatment, Baseline VAS knee pain, site, treatment-by-site interaction, lesion-grade, and lesion-grade interaction as independent variables.~Scores ranged from 0 to 100 with pain intensity measured as none, mild, moderate, or severe:~No pain (0-4) Mild pain (5-44) Moderate pain (45-74) Severe pain (75-100)~VAS scores were calculated as:~Change in VAS knee pain score from Baseline at Week (x) or Day (x) = VAS knee pain at Week (x) or Day (x) - VAS knee pain at Baseline"|Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET|Not all participants completed the VAS pain score questionnaire.|||units on a scale||Standard Deviation|Mean
2635401|NCT01803880|Secondary|Change in KOOS Scores From Baseline|"The scores of 5 subscales of Knee Injury and Osteoarthritis Outcome Score (KOOS) (i.e., pain, other symptoms, function in daily living [ADL], function in sport and recreation [Sport/Rec], and knee-related Quality of Life [QoL]) change from Baseline were summarized descriptively by treatment group. An ANCOVA model was used to compare the differences in the devices for change from Baseline in the KOOS subscale score at each of the scheduled post-operative visits.~Each subscale response was based on a 5-point Likert system with each response score ranging from 0 (no problems) to 4 (extreme problems). A score of 100 indicated no problems and a score of 0 indicated extreme problems.~The KOOS calculations were calculated as follows:~Individual KOOS subscale scores = 100 - (mean of the observed items within the subscale x100) / 4~Change from Baseline in KOOS at Week (x) or Day (x) = KOOS at Week (x) or Day (x) - KOOS at Baseline"|Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET|Not all participants completed the KOOS questionnaires.|||score on a scale||Standard Deviation|Mean
2635402|NCT01803880|Secondary|Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation|"Knee examination with respect to patella subluxation/ dislocation (centered, subluxable, subluxed and dislocated) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits.~The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury.~There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows:~IKDC score = (raw score - lowest possible score / range of scores) x100"|Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET|Not all participants completed the IKDC score questionnaires.|||Participants|||Count of Participants
2635403|NCT01803880|Secondary|Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation|"Knee examination with respect to patella position (obvious baja, normal, obvious alta) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits.~The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury.~There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows:~IKDC score = (raw score - lowest possible score / range of scores) x100"|Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET|Not all participants completed the IKDC score questionnaires.|||Participants|||Count of Participants
2635404|NCT01803880|Secondary|Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation|"Knee examination with respect to alignment (obvious varus, normal, obvious valgus) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits.~The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury.~There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows:~IKDC score = (raw score - lowest possible score / range of scores) x100"|Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET|Not all participants completed the IKDC score questionnaires.|||Participants|||Count of Participants
2635405|NCT01803880|Secondary|Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation|"Knee examination with respect to generalized laxity (tight, normal, lax) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits.~The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury.~There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows:~IKDC score = (raw score - lowest possible score / range of scores) x100"|Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET|Not all participants completed the IKDC score questionnaires.|||Participants|||Count of Participants
2635406|NCT01803880|Secondary|Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline.|"The scores of three domains of IKDC Subjective Knee Evaluation Form (i.e., [1] symptoms, including pain, stiffness, swelling, locking/catching, and giving way; [2] sports and daily activities; and [3] current knee function) at Baseline, each of scheduled post-operative visits and changes from Baseline were summarized descriptively by treatment group.~Change from Baseline in IKDC = IKDC at Baseline + Pseudo-site + Treatment + Treatment*Pseudo-site~The IKDC score was interpreted by summing the scores for the individual questions and then transforming the score to a scale that ranged from 0 to 100:~Individual domain IKDC score = [raw score - lowest possible score/range of scores] x 100~The IKDC total score was interpreted as higher scores = higher function, lower scores = lower function.~Treatment*Pseudo-site interaction term was non-significant at the 0.05 level and hence was dropped from the statistical method."|Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/Early Termination (ET)|Not all participants completed the IKDC score questionnaires.|||score on a scale||Standard Deviation|Mean
2635439|NCT01803269|Secondary|Continuous Change in Tumor Size.|Change in sum of longest diameters of all target lesions from baseline to end of cycle 2.|Up to 56 days|Patients completing two cycles of therapy.|||percentage of baseline||Standard Error|Mean
2635455|NCT01803074|Secondary|Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B|AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval.|Pre-dose Day 1 and Day 28|Pharmacokinetic Population.|||Nanogram*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
2635407|NCT01803880|Primary|Change From Baseline in Knee and Osteoarthritis Outcomes Scores (KOOS) at Week 52 Post-operative|"The scores of 5 subscales of KOOS (i.e., Pain, other Symptoms, Function in daily living [ADL], Function in Sport and Recreation [Sport/Rec] and knee related Quality of Life [QoL]) at Baseline, Week 52 and change from Baseline were summarized descriptively by treatment group. The average of KOOS subscale scores was considered as the primary endpoint. For any subject if the value of effectiveness parameter was missing at Week 52 then it was imputed by last observed post-Baseline value (LOCF method).~Each subscale response is based on a 5-point Likert system with each response score ranging from 0 (no problems) to 4 (extreme problems). Each subscale score is calculated independently. A score of 100 indicated no problems and a score of 0 indicated extreme problems.~KOOS subscale score = 100 - (mean of the observed items within the subscale x100 / 4)"|Postop Week 52|ITT Population|||score on a scale||Standard Error|Least Squares Mean
2635408|NCT01803737|Secondary|Autonomous and Controlled Motivation|At week 12, participants completed the 13-item TSRQ to assess motivation to continue to participate in the program if given the opportunity. The TSRQ represents participants' reasons for continuing participation in a weight loss program via participants' endorsement of statements of autonomous and controlled motivation. Responses were given using a 7-point Likert scale (1 = not at all true to 7 = very true). The responses on the autonomous items (5) and controlled items (8) were averaged.|Week 12||||units on a scale||Standard Deviation|Mean
2635409|NCT01803737|Secondary|Change in Weight Loss Self-efficacy|Self-efficacy for weight loss was assessed at week 0 and 12 using a 20-item Weight Efficacy Lifestyle Questionnaire (WEL). The total score ranges from 0-180. Higher values represent greater beliefs toward the completion of weight management behaviors.|Week 0 and 12||||units on a scale||Standard Deviation|Mean
2635410|NCT01803737|Secondary|Completion of Self-monitoring of Dietary Intake and Physical Activity|The frequency that participants engaged in the self-monitoring of dietary intake and physical activity was assessed at week 12. The diaries were completed weekly throughout the study.|Week 0 and 12||||percentage of diaries completed|Participants|Standard Deviation|Mean
2635411|NCT01803737|Secondary|Change in Dietary Intake: % Carbohydrate|A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.|Week 0 and 12||||percentage of carbohydrate intake||Standard Deviation|Mean
2635412|NCT01803737|Secondary|Change in Dietary Intake: % Protein|A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.|Week 0 and 12||||percentage of protein intake||Standard Deviation|Mean
2635413|NCT01803737|Secondary|Change in Dietary Intake: % Fat|A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.|Week 0 and 12||||percentage of fat intake||Standard Deviation|Mean
2635414|NCT01803737|Secondary|Change in Dietary Intake: Kcals/Day|A questionnaire will be used to assess self-reported food intake. This will be used to estimate calories, dietary fat, protein, and carbohydrates consumed.|Week 0 and 12||||kcals/day||Standard Deviation|Mean
2635415|NCT01803737|Secondary|Change in Physical Activity|A questionnaire will be used to measure and quantify energy expenditure from physical activity.|Week 0 and 12||||kcals/wk||Standard Deviation|Mean
2635416|NCT01803737|Primary|Change in Body Weight|Body weight will be measured on a digital scale to assess change in body weight over the 12-week intervention period.|Week 0 and 12||||kg||Standard Deviation|Mean
2635417|NCT01803711|Secondary|Leeds Sleep Evaluation Questionnaire (LSEQ)||12 weeks from baseline|Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.||||||
2635418|NCT01803711|Secondary|Visual Analog Scale for Pain (VAS-P)||12 weeks from baseline|Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.||||||
2635419|NCT01803711|Secondary|Visual Analog Scale for Energy (VAS-E)||12 weeks from baseline|Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.||||||
2635420|NCT01803711|Secondary|Short Form Health Survey (SF-12)||12 weeks from baseline|Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.||||||
2635421|NCT01803711|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)||12 weeks from baseline|Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.||||||
2635422|NCT01803711|Primary|Hospital Anxiety and Depression Scale|Hospital Anxiety and Depression Scale: This is a validated scale for measuring depression/anxiety symptoms in patients with medical conditions.|12 weeks from baseline|Planned statistical analyses were not performed due to lack of adequate sample size. The data collected were not intended to be summarized if there were fewer than 10 participants.||||||
2635423|NCT01803646|Primary|Safety: Frequency of Subjects With Deterioration of Hearing at Follow up Visit 2 (FUV2)|"Occurence of deterioration of hearing (Air and Bone conduction) in the treated ear at FUV2.~Deterioration is defined as a deterioration of hearing threshold of at least 15 dB from Baseline at the average of 2 contiguous frequencies."|Day 35|Valid for Safety dataset was used. Of the 336 valid for safety subjects, 323 could be evaluated for this endpoint.|||Participants|||Count of Participants
2635440|NCT01803269|Secondary|Response Rates According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (Cohort A)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 2 years|Patients initiating treatment (i.e., exclude 3 withdrawals prior to starting treatment).|||Participants|||Count of Participants
2635441|NCT01803269|Primary|Progression-free Survival|Time from enrollment to disease progression or death from any cause|12 months||||months||95% Confidence Interval|Median
2636685|NCT01789203|Secondary|Number of Patients With Bacteremia at 6 Months|Number of patients with bacteremic infection at 6 months. Bacteremia defined by a single positive blood culture that was not thought to be contaminated.|6 months||||Participants|||Count of Participants
2635424|NCT01803646|Primary|Co-Primary Efficacy: Improvement in Tinnitus Functional Index (TFI) Total Score From Baseline to FUV3|"The TFI was recorded on an electronic device (electronic patient reported outcome) at Treatment Visit 1 (TV1), before randomization, and at Follow up Visit 1 (FUV1), FUV2 and FUV3.~The TFI is a patient reported outcome questionnaire and contains 25 questions. It includes eight subscales: Intrusive, Sense of Control, Cognitive, Sleep, Auditory, Relaxation, Quality of Life, and Emotional. Each question is to be rated on a NRS between 0 and 10 (or 0 to 100%), with a recall period of over the past week.~The TFI total score is considered as valid if there are evaluable answers for at least 19 of the 25 items (76% of items) (Meikle et al. 2012). The repondent's overall TFI score is within a 0-100 range. For the subscales the range is the same. A lower value represents an improvement for all scales.~Please refer to the following publicly available link for more information: http://download.lww.com/wolterskluwer_vitalstream_com/PermaLink/EANDH/A/EANDH_2011_09_27_HENRY_200593_SDC15.pdf"|D0 (=TV1) versus Day 84 (=FUV3)|"Valid for Efficacy dataset includes all subjects treated with at least one i.t. injection (AM-101 or placebo), a valid TLQ NRSLoudest or TFI rating at baseline and at least one valid post-baseline rating.~Ten subjects had neither TLQ nor TFI baseline plus additional 25 subjects had no baseline for the TFI resulting in 301 evaluable subjects."|||units on a scale||95% Confidence Interval|Least Squares Mean
2635425|NCT01803646|Primary|Efficacy: Change in Patient-reported Tinnitus Loudness Questionnaire (TLQ) Improvement From Baseline to Follow up Visit 3 (FUV3)|"Starting at the screening visit (SV), each subject recorded the following numerical rating scales (NRS) throughout the entire study duration:~- Tinnitus loudness at its loudest within the last 24 hours (Tinnitus Loudness Questionnaire [TLQ] NRSLoudest). Subjects were asked On a scale from 0 to 10, where 0 represents no tinnitus and 10 represents extremely loud tinnitus, what one number best describes your tinnitus at its loudest in the last 24 hours (including right now)? TLQ NRSLoudest was collected from SV (D-14) to the evening before FUV3 (D83). The ratings were to be recorded every day before going to sleep on an electronic device.~As Baseline the10 ratings of the screening period before the first treatment were averaged. For the FUV3 endpoint, the ratings of the 7 days before FUV3 were averaged."|Screening (D-14) versus final follow-up (D83)|"Valid for Efficacy dataset includes all subjects treated with at least one i.t. injection (AM-101 or placebo), a valid TLQ NRSLoudest or TFI rating at baseline and at least one valid post-baseline rating.~Ten subjects had neither TLQ nor TFI baseline and 2 subjects had no valid rating for the TLQ resulting in 324 evaluable subjects."|||units on a scale||95% Confidence Interval|Least Squares Mean
2635426|NCT01803607|Secondary|Change From Baseline in Serum N-terminal Propeptide of Type 1 Collagen (s-P1NP)|s-P1NP is a biochemical marker of bone resorption. s-P1NP was measured and expressed as ng/mL at Baseline and Month 12, and results are expressed as percentage change from baseline.|Baseline and Month 12|The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results|||Percentage Change from Baseline||Standard Error|Geometric Mean
2635427|NCT01803607|Secondary|Change From Baseline in Serum Bone Specific Alkaline Phosphatase (s-BSAP)|s-BSAP is a biochemical marker of bone resorption. s-BSAP was measured and expressed in ng/mL at Baseline and Month 12, and results are shown as percentage change from baseline.|Baseline and Month 12|The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results|||Percentage Change from Baseline||Standard Error|Geometric Mean
2635428|NCT01803607|Secondary|Change From Baseline in Urine N-telopeptides of Type 1 Collagen Corrected for Creatinine (u-NTx/Cr)|The u-NTx/Cr ratio is a biochemical marker of bone resorption. u-NTx/Cr was measured at baseline and Month 12 and expressed in nM:mM and results are expressed as percentage change from baseline.|Baseline and Month 12|The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results.|||Percentage Change from Baseline||Standard Error|Geometric Mean
2635429|NCT01803607|Secondary|Change From Baseline in Urine C-telopeptides of Type I Collagen (u-CTx)|u-CTx is a biochemical marker of bone resorption. At baseline and Month 12, u-CTx was measured and expressed in ug/mL and results are expressed as percentage change from baseline.|Baseline and Month 12|The PP population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results.|||Percentage Change from Baseline||Standard Error|Geometric Mean
2635430|NCT01803607|Secondary|Change From Baseline in Serum C-telopeptides of Type 1 Collagen (s-CTx)|s-CTx is a biochemical marker of bone resorption. At baseline and Month 12, s-CTx was measured and expressed in ng/mL and results are expressed as percentage change from baseline.|Baseline and Month 12|The Per Protocol (PP) population includes all participants who received 1 dose of study drug, had the necessary baseline and post-baseline data, and did not have any protocol violations that may substantially impact results.|||Percent Change from Baseline||Standard Error|Geometric Mean
2635431|NCT01803607|Secondary|Percent Change From Baseline to Month 12 in Trochanter, Total Hip, and Lumbar Spine BMD|DXA was used to determine the change from baseline in trochanter, total hip, and lumbar spine BMD at Month 12.|Baseline and Month 12|The FAS includes all randomized participants who took at least one dose of study medication and had the relevant baseline and follow-up measurements|||Percentage Change from Baseline||Standard Error|Mean
2635432|NCT01803607|Secondary|Percent Change From Baseline to Month 24 in Femoral Neck BMD: Within-Group Comparison of Odanacatib|DXA was used to determine the within-group change from baseline in femoral neck BMD at Month 24.|Baseline and Month 24|The trial was terminated prematurely, thus this analysis was not conducted.||||||
2635433|NCT01803607|Primary|Percent Change From Baseline to Month 12 in Femoral BMD|Dual-energy X-ray absorptiometry (DXA) was used to determine the change from baseline in femoral neck BMD at Month 12.|Baseline and Month 12|The Full Analysis set (FAS) includes all randomized participants who took at least one dose of study medication and had the relevant baseline and follow-up measurements.|||Percent Change from Baseline||Standard Error|Mean
2635434|NCT01803464|Secondary|Bone Mass|Change in bone mineral content in the distal femur from baseline to 6 months, as measured by dual-energy X-ray absorptiometry (DXA)|baseline to 6 months||||percent change||Standard Deviation|Mean
2635435|NCT01803464|Secondary|Muscle Volume|Change in muscle volume of the midleg from baseline to 6 months, as measured by MRI|baseline to 6 months||||percent change||Standard Deviation|Mean
2635442|NCT01803204|Other Pre-specified|Levels of Anxiety After Educational Intervention|"The levels of anxiety during the perioperative period will be measured with the State-Trait Anxiety Inventory (STAI).~The STAI has 40 items, 20 items allocated to each of the S-Anxiety and T-Anxiety sub-scales Responses for the S-Anxiety scale assess intensity of current feelings at this moment: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Responses for the T-Anxiety scale assess fre- quency of feelings in general: 1) almost never, 2) some- times, 3) often, and 4) almost always.~Scoring. Item scores are added to obtain subtest total scores. Scoring should be reversed for anxiety-absent items (19 items of the total 40).~Score interpretation. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale For results this intervention was considered S-STAI Anxiety with lower scores (< 39) after the intervention"|The STAI will be applied on the seventh day after surgery||||score on a scale||Standard Deviation|Mean
2635443|NCT01803204|Secondary|Average Test Arrangements on Surgery|"The patient's knowledge about the surgery will be assessed by a test developed by the researcher (A test with 10 multiple choice questions, each questions with 4 alternatives, about care after surgery. Each questions value 1 point, for better results was considered higher 7 points and for worse results was considered low 5 points. A total value for the Knowledge test was 10 points (rage 0-10) The acceptable score to understand that the patient is aware of the surgery was 7.~This was applied on two occasions: first contact with the patient before surgery, signed a consent form before the start researcher educational intervention (during the preoperative phase).~The second test will be given at the first follow-up visit with the surgeon (seventh postoperative day)"|This will be delivered in the first contact with the patient before surgery and on the seventh day after surgery||||score on a scale||Standard Deviation|Mean
2635444|NCT01803204|Primary|Number of Patients With Clinical Changes During the Postoperative Recovery|A review of the patient's recovery after surgery will occur during follow-up visits with the surgeon, It was rated the care of oral hygiene, nutrition, mobility and sensitivity, appearance of lips, swelling, pain and sleep . The patient will be accompanied by the researcher during the return and the data will be evaluated and investigated as annotated patient outcomes.|this measure will be assessed weekly in the first forty days postoperatively (seventh day, fourteenth day, twenty-first day and fortieth day after the surgery)||||participants|||Number
2635445|NCT01803074|Secondary|Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Systolic BP (millimeter of mercury [mmHg]): value >140 and change from Baseline >20, or value <90 and change from Baseline <-20; Diastolic BP (mmHg): value >90 and change from Baseline >10, or value <55 and change from Baseline <-10.|Day 1 to end of the study (Day 42)|All Treated Subjects Population.|||Participants|||Count of Participants
2635446|NCT01803074|Secondary|Number of Participants With Abnormal Changes in Physical Examination|Participants with abnormal changes in physical examination is presented.|Day 1 to end of the study (Day 42)|All Treated Subjects Population.|||Participants|||Count of Participants
2635447|NCT01803074|Secondary|Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)|Participants with out of range ECG intervals were summarized. Criteria used to determine ECG results that are outside of a pre-specified range: PR (milliseconds [msec]): Value >200; QRS (msec): Value >120; QT (msec): Value >500 or change from Baseline >30; corrected QT interval Fridericia's formula (QTcF) (msec): Value >450 or change from Baseline >30.|Day 1 to end of the study (Day 42)|All Treated Subjects Population.|||Participants|||Count of Participants
2635448|NCT01803074|Secondary|Number of Participants With Clinically Significant Changes in Heart Rate|Heart rate was measured after the participants had been seated quietly for at least 5 minutes. Criteria used to determine heart rate that are outside of a pre-specified range, where changes from Baseline are based on matched postural positions and are calculated as parameter value - Baseline parameter value: Value >100 and change from Baseline > 30, or Value < 55 and change from Baseline < -15.|Day 1 to end of the study (Day 42)|All Treated Subjects Population.|||Participants|||Count of Participants
2635449|NCT01803074|Secondary|Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline|Laboratory abnormalities were determined and graded using the Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0, December 2004.|Day 1 to up to end of the study (Day 42)|All Treated Subjects Population.|||Participants|||Count of Participants
2635450|NCT01803074|Secondary|Plasma Half-life: Part A and C|Half-life of the terminal log-linear phase, (T-half), was calculated as natural logarithm of 2 (ln2)/λ, where λ is the absolute value of the slope of the terminal log-linear phase. T-half was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7).|Baseline (Day 1) to Day 10|Pharmacokinetic Population|||Hours||Full Range|Median
2635451|NCT01803074|Secondary|Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C|Css-avg was calculated by the quotient of AUC(TAU) and the dosing interval (24 h). Css-avg was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7).|Baseline (Day 1) to Day 10|Pharmacokinetic Population.|||Nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2635452|NCT01803074|Secondary|Degree of Fluctuation (DF): Part A and C|DF was calculated as the difference between Cmax and Cmin divided by Css-avg. DF was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7).|Baseline (Day 1) to Day 10|Pharmacokinetic Population.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2635453|NCT01803074|Secondary|Apparent Total Body Clearance: Part A and C|Apparent total body clearance was derived by non-compartmental methods, using a validated pharmacokinetic (PK) analysis program: KineticaTM 5.0 within eToolbox (version 2.7).|Baseline (Day 1) to Day 10|Pharmacokinetic Population.|||Milliliters/minute||Geometric Coefficient of Variation|Geometric Mean
2635454|NCT01803074|Secondary|Accumulation Index (AI): Part A and C|Accumulation index was calculated by dividing the AUC(tau) or Cmax or C24 of BMS-955176 on Day 10 by the AUC(TAU) or Cmax or C24, respectively, of BMS-955176 on Day 1.|Baseline and Day 10|Pharmacokinetic Population.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2636887|NCT01787006|Secondary|Rate of Participants Who Were Alive at 1 Year|Overall Survival (OS) was defined as freedom from death of any cause. Time to death was calculated from the day of randomization.|1 year||||percentage of participants||95% Confidence Interval|Number
2635456|NCT01803074|Secondary|Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C|AUC(tau) was defined as the area under the plasma concentration - time curve over the dosing interval.|Pre-dose Day 1 and Day 10|Pharmacokinetic Population.|||Nanogram*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
2635457|NCT01803074|Secondary|Plasma Concentration 24 Hours Post-Dose (C24) - Part B|C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose.|24 hours post-dose|Pharmacokinetic Population.|||Nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2635458|NCT01803074|Secondary|Maximum Observed Plasma Concentrations (Cmax) - Part B|Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Pre-dose Day 1 and Day 28|Pharmacokinetic Population.|||Nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2635459|NCT01803074|Secondary|Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C|C24 was defined as the plasma concentration of BMS-955176 at 24 hours post-dose.|24 hours post-dose|Pharmacokinetic Population.|||Nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2635460|NCT01803074|Secondary|Maximum Observed Plasma Concentrations (Cmax) - Part A and C|Cmax was defined as the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Pre-dose Day 1 and Day 10|Pharmacokinetic Population.|||Nanogram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2635461|NCT01803074|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) - Part B|Tmax was directly determined from concentration time data.|Pre-dose Day 1 and Day 28|Pharmacokinetic Population.|||Hours||Full Range|Median
2635462|NCT01803074|Secondary|Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B|Percent Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.|Baseline (Day 1) up to Day 42|All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2635463|NCT01803074|Secondary|Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C|Percent Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.|Baseline (Day 1) up to Day 24|All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2635464|NCT01803074|Secondary|Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B|Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.|Baseline (Day 1) up to Day 42|All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed.|||Cells/microliter||Standard Deviation|Mean
2635465|NCT01803074|Secondary|Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C|Change in the CD4+ and CD8+ cell counts from Baseline were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 + ATV or BMS-955176 + ATV + RTV therapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.|Baseline (Day 1) up to Day 24|All Treated Subjects Population. Only those participants with data available at the specified time points were analyzed.|||Cells/microliter||Standard Deviation|Mean
2635466|NCT01803074|Secondary|Time to Maximum Decline in Log 10 HIV-1 RNA - Part B|Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Time to maximum decline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.|Baseline (Day 1) up to Day 42|All Treated Subjects Population.|||Hours||Full Range|Median
2635467|NCT01803074|Secondary|Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C|Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Time to maximum decline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.|Baseline (Day 1) up to Day 24|All Treated Subjects Population.|||Hours||Full Range|Median
2635468|NCT01803074|Secondary|Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B|Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Maximum decline from Baseline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.|Baseline (Day 1) up to Day 42|All Treated Subjects Population.|||Log10 copies/mL||Full Range|Median
2635469|NCT01803074|Secondary|Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C|Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Maximum decline from Baseline in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.|Baseline (Day 1) up to Day 24|All Treated Subjects Population.|||Log10 copies/mL||Full Range|Median
2635470|NCT01803074|Secondary|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), and Discontinuations Due to AEs During the Study|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.|Day 1 to end of the study (Day 42)|All Treated Subjects Population.|||Participants|||Count of Participants
2637132|NCT01784848|Secondary|Effect on Central Blood Pressure Augmentation Index and Pulse Wave Velocity|Change on central blood pressure augmentation index and pulse wave velocity as measured by SphygmoCor device|12, 24, 36, 48 and 60 months|||||||
2635471|NCT01803074|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C|Time to reach the maximum plasma concentration was directly determined from concentration time data.|Pre-dose Day 1 and Day 10|Pharmacokinetic Population comprised of all participants who received any study medication and had any available concentration-time data.|||Hours||Full Range|Median
2635472|NCT01803074|Primary|Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11|Antiviral activity of BMS-955176 was estimated by measuring the plasma HIV-1 RNA levels in the HIV-1 infected participants. Change in the plasma HIV-1 RNA levels were measured in the participants infected with HIV-1 clade B and C who received BMS-955176 monotherapy. Baseline was Day 1. Change from Baseline was post-Baseline individual values minus Baseline values.|Baseline (Day 1) and Day 11 after the final dose with BMS-955176|All Treated Subjects Population comprised of all participants who had received at least one dose of study drug.|||Log10 copies per milliliter (c/mL)||Standard Deviation|Mean
2635473|NCT01802879|Primary|Overview of Adverse Events (Safety Set)|Adverse events were collected from baseline up to 30 days post treatment at scheduled visits. Severity of adverse events was assessed according to the current version of Common Terminology Criteria for Adverse Events (CTCAE). If CTCAE grading did not exist for an adverse event, the severity of mild, moderate, severe, and life-threatening, corresponding to Grades 1 - 4, was used|Baseline up to approximately 60 months||||participants|||Number
2635474|NCT01802879|Secondary|Percentage of Patients With Clinical Benefit as Assessed by the Investigator.|Patients were assessed by investigators at scheduled visits to determine if patient continued to benefit from panobinostat therapy.|baseline up to approximate 5 years||||Participants|||Count of Participants
2635475|NCT01802775|Secondary|Number of Participants With Amputations|Number of participants with amputations within 6 months|within 6 months|Safety Analysis Set|||Participants|||Count of Participants
2635476|NCT01802775|Secondary|Number of Adjudicated Major Adverse Cardiovascular Events During the Overall Study Period|Number of Adjudicated Major Adverse Cardiovascular Events (MACE) which is a composite of non-fatal myocardial infarction (MI), non-fatal stroke and cardiovascular death|within 6 months|mITT Set 1 (Safety Analysis Set), defined as the participants who received at least 1 dose of study drug|||Participants|||Count of Participants
2635477|NCT01802775|Secondary|Safety Assessments|"Number of participants with serious adverse events (SAEs) within 6 months~Note: Based on changes to the database structure, clinically significant changes in physical or laboratory parameters are recorded as adverse events (AEs). Details of non-serious adverse events are reported at the 5% reporting threshold in the AE module, as is all-cause mortality."|within 6 months|Safety Analysis Set|||Participants|||Count of Participants
2635478|NCT01802775|Secondary|Percentage of Participants With Major, Clinically Relevant Non-major (CRNM), and Minor Bleeding During Treatment|The percentage of participants with major, clinically relevant non-major, and minor bleeding occurring during treatment, within 3 months|within 3 months|Safety Analysis Set, defined as all participants who received at least one dose of study drug|||percentage of participants||95% Confidence Interval|Number
2635479|NCT01802775|Primary|Percentage of Participants With First Re-stenosis / Re-occlusion|Percentage of participants with re-stenosis/re-occlusion during treatment within 6 months - only the first occurrence of re-stenosis / re-occlusion was counted for each participant|within 6 months|Modified Intent-to-Treat (mITT), defined as all randomized subjects who received at least one dose of the study study and had at least one post-dose duplex scanning|||percentage of participants|||Number
2635480|NCT01802775|Primary|Percentage of Participants With Clinically Relevant Bleeding During Treatment|Percentage of participants with clinically relevant bleeding, defined as major bleeding or clinical relevant non-major bleeding, in the on-treatment period based on International Society of Thrombosis and Haemostasis (ISTH)|at 3 months|Safety Analysis Set, defined as all participants who received at least one dose of study drug|||percentage of participants||95% Confidence Interval|Number
2635481|NCT01802710|Other Pre-specified|Hospital Anxiety and Depression Scale|It is a 14-item measure: 7 items evaluate depression (the HADS-D subscale) and 7 evaluate anxiety (the HADS-A subscale). For each subscale items range from 0 to 21. A subscale score of 0-7 indicates the absence of anxiety or depression; a score of 8-10 indicates a possible case of anxiety or depression; and a score of 11 or higher indicates the presence of anxiety or depression. It has been adapted and validated in a Spanish population|Participants will be followed at the recruit moment (t0) after treatment (t1) and six months after treatment (t2)|The number analyzed in the rows differs from overall number analyzed because, as it is occur in follow-up studies, patients were lost from T0 to T2.|||units on a scale||Standard Deviation|Mean
2635482|NCT01802710|Secondary|Subjective Clinical Improvement|"Subjective clinical improvement was measured by a question about how patients feel in regard to the functional dyspepsia (In relation to functional dyspepsia, how would you rate your health now? a)much better; b) quite a lot better; c) somewhat better; d) about the same; e) somewhat worse; f) quite a lot worse; g) much worse"|Subjective clinical improvement it is measured after treatment (t1) and six months after treatment (t2)||||Participants|||Count of Participants
2635483|NCT01802710|Primary|Change From Baseline in DYSPEPSIA RELATED HEALTH SCALE (DRHS)|The Dyspepsia Related Health Scale (DRHS) is a self-reported dyspepsia-specific questionnaire that consists of four scales: severity of common symptoms, pain intensity, pain disability, and satisfaction with dyspepsia-related health. The score, for each scale, ranges between 0 and 100, with 0 representing the most severe situation and 100 the least severe. It also yields a global score that ranges from 0 to 100, with higher scores indicating less severe dyspepsia. The adapted and validated Spanish version of this questionnaire is known as QoL-PEI (Quality of Life in relation to Stomach and Intestinal Problems Questionnaire). Its reliability was found to be satisfactory (Cronbach's alpha 0.92). Its factorial analysis confirmed the four scales found by the DRHS but added a global score scale. The convergent validity was moderate (0.54).|Participants will be followed at the recruit moment (t0) after treatment (t1) and six months after treatment (t2)|the number analyzed in the rows differs from overall number analyzed because, as it is occur in follow-up studies, patients were lost from T0 to T1.|||units on a scale||Standard Deviation|Mean
2635709|NCT01800162|Secondary|Quantification of Re-interventions Needed to Manage a Woman With a PPUL|"Outcomes include:~number of interventions beyond that of intended initial strategy in each group~additional number of MTX injections~additional surgical procedures~uterine evacuation (or dilation and curettage)~laparoscopy~laparotomy"|6 weeks|||||||
2635484|NCT01802632|Secondary|Best Objective Response (BOR) for 80mg AZD9291 Extension Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)|All patients in the 80mg AZD9291 extension part of the study (second line or later, EGFR T790M mutation positive by central testing) who received at least one dose of AZD9291 and had measurable disease (by investigator assessment) at baseline.|||% of participants|||Number
2635485|NCT01802632|Primary|Objective Response Rate (ORR) for Extension Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (by independent central review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 12 months (at the time of analysis)|All patients in the 80mg AZD9291 extension part of the study (second line or later, EGFR T790M mutation positive by central testing) who received at least one dose of AZD9291 and had measurable disease (by independent central review) at baseline.|||% of participants||95% Confidence Interval|Number
2635486|NCT01802632|Secondary|Progression-Free Survival (PFS) for Dose Expansion Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of first dose until the date of PD (by independent central review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from AZD9291 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)|All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.|||months||95% Confidence Interval|Median
2635487|NCT01802632|Secondary|Duration of Response (DoR) for Dose Expansion Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. DoR was defined as the time from the date of first documented response (CR or PR that was subsequently confirmed) until the date of documented progression (PD) or death in the absence of disease progression (by investigator assessment).|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)|All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.|||months||95% Confidence Interval|Median
2635488|NCT01802632|Primary|Best Objective Response (BOR) for Dose Escalation Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. Not evaluable (NE): TL response is missing and there is no evidence of progression of NTLs and no new lesions. BOR is the best response (by investigator assessment) a patient has achieved where the order of best to worst is CR, PR, SD, PD, NE prior to or at progression and prior to further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 25 months (at time of analysis)|All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.|||% of participants|||Number
2635489|NCT01802632|Primary|Objective Response Rate (ORR) for Dose Expansion Population|Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions. ORR is the percentage of patients with at least 1 visit response of CR or PR (by investigator assessment) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.|RECIST tumour assessments every 6 weeks from randomisation until objective disease progression, up to approximately 21 months (at time of analysis)|All pre-treated EGFR T790M mutation positive (by central testing) patients who received at least one dose of AZD9291.|||% of participants||95% Confidence Interval|Number
2635490|NCT01802580|Secondary|Disease Severity With IGA Assessment|Investigator's Global Assessment (IGA): Similar to assessment performed in clinical practice, based on a 6-point scale from 0 (completely clear) to 5 (very severe). Treatment success is defined as score of 0 or 1 (clear or almost clear).|baseline and 12 months|data not collected in all participants at month 12|||score on a scale||Standard Deviation|Mean
2635642|NCT01801111|Secondary|Cmax of Alectinib Metabolite|Cmax for alectinib metabolite was estimated from plasma concentration versus time data by non-compartmental methods of analysis using Phoenix WinNonlin v6.2 software.|Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1|Analysis was performed on PK Evaluable Population. Here, ‘Number Analyzed’=number of participant evaluable for specified category.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2635491|NCT01802580|Secondary|Disease Severity With PASI|Psoriasis Area and Severity Index (PASI): The Psoriasis Area and Severity Index is commonly used in clinical trials as a granular measure of disease severity. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). It is weighted for area in each of the four body regions and scores erythema, induration and desquamation on an overall scale from 0-72. Treatment success is defined as a 75% reduction in PASI score from baseline value.|baseline and 12 months|Data not collected on all participants|||score on a scale||Standard Deviation|Mean
2635492|NCT01802580|Secondary|Mean of Days Per Week Medication Was Taken - Internet Survey|The average number of days per week that participants reported taking the medication in the internet survey|up to 12 months|Includes all participants randomized to this arm. Because the other arm has no internet reminder, there will only be one arm reported for this measure.|||days per week||Full Range|Mean
2635493|NCT01802580|Primary|Measured MEMS Adherence- Number of Days With a Correct Number of Doses Taken|"Number of days patients adhered to the treatment is reported. All subjects receive the MEMs caps on their medication and it is reported by the number of days that the dosage was taken correctly, either with or without internet reminder survey intervention.~number of days with a correct number of doses taken"|up to 12 months||||Days||Full Range|Mean
2635494|NCT01802554|Secondary|Positive and Negative Affect Schedule|"This scales contains ten items assessing Negative Affect. Items included are adjectives, such as distressed, ashamed, and Participants rated each adjective based on how they felt over the past few weeks using a 5-point scale with responses ranging from 1 (very slightly to not at all) to 5 (extremely). The scale's minimum score is 10 and maximum score is 50. Lower scores represent better outcomes."|Change from Baseline Negative Affect at 8-weeks||||units on a scale||Standard Error|Mean
2635495|NCT01802554|Secondary|Positive and Negative Affect Schedule|"This scales contains ten items assessing Positive Affect. Items included are adjectives, such as interested, strong, and inspired. Participants rated each adjective based on how they felt over the past few weeks using a 5-point scale with responses ranging from 1 (very slightly to not at all) to 5 (extremely). The scale's minimum score is 10 and maximum score is 50. Higher scores represent better outcomes."|Change from Baseline Positive Affect at 8-weeks||||units on a scale||Standard Error|Mean
2635496|NCT01802554|Primary|Interleukin-6 (IL-6)|IL-6 is one of many biomarkers represented in the inflammatory cascade which is initiated during an immune response. Prospectively, increased plasma IL-6 is also associated with future myocardial infarction in healthy men and increasing concentrations of IL-6 have been associated with both nonfatal myocardial infarction and fatal Coronary Heart Disease (CHD) in longitudinal studies of population-based cohorts. Higher concentrations of IL-6 raise CHD risk. Blood was collected by a research nurse in the caregivers' homes through a 22-gauge forearm catheter after a 20 min rest. Blood for IL-6 was dispensed in Ethylenediaminetetraacetic acid (EDTA) tubes and spun at 3000 g for 10 minutes at 4 to 8 degrees Celsius. Obtained plasma was stored at minus 80 degrees Celsius until analyzed. Plasma IL-6 (Meso Scale Discovery, Gaithersburg, MD) was determined via highsensitive enzyme-linked immunosorbent assays. Intra- and interassay coefficients of variation were less than 5 percent.|Change from Baseline IL-6 at 8-weeks||||pg/ml||Standard Error|Mean
2635497|NCT01802554|Primary|D-dimer|D-dimer is an indicator of fibrin formation and its subsequent lysis and is a useful biomarker representing overall activation of blood coagulation. High concentrations of D-dimer have been linked prospectively to onset of Coronary Heart Disease. Blood was collected by a research nurse in the caregivers' homes through a 22 gauge forearm catheter after a 20 minute rest. Blood for D-dimer was dispensed into polypropylene tubes with 3.8 percent sodium citrate and spun at 1600 g for 10 minutes at room temperature. Obtained plasma was stored at minus 80 degrees Celsius until analyzed. Plasma D-dimer (Asserachrom Stago, Asnieres, France) was determined via high sensitive enzyme-linked immunosorbent assays. Intra- and interassay coefficients of variation were less than 5 percent.|Change from Baseline D-dimer at 8-weeks||||ng/ml||Standard Error|Mean
2635498|NCT01802554|Primary|Brief Center for Epidemiologic Studies Depression Scale (CESD)|The Brief CESD is a measure of depressive symptoms. The scale's minimum score is 0 and maximum score is 30. Lower scores represent fewer depressive symptoms and thus better outcomes.|Change from Baseline CESD at 8-weeks||||units on a scale||Standard Error|Mean
2635499|NCT01802515|Secondary|Change Score in the Center for Epidemiological Studies-Depression (CES-D) Scale|Center for Epidemiological Studies-Depression. The CES-D is a 20-item self-report measure of depressive symptoms. Each of the 20 items can yield a score from 0 to 3 for a maximum total CES-D score of 60. Larger values represent more severe symptoms. It is a validated instrument with a score of 16 or more indicating clinically significant depression. The CES-D change score was computed as (total baseline CES-D score - total CES-D score at end of study).|8 weeks of treatment|Descriptive statistics were calculated for all enrolled subjects. A full statistical analysis was not performed due to study termination.|||units on a scale||Standard Deviation|Mean
2635500|NCT01802515|Primary|Treatment Retention|The number of participants completing all 8 weeks of treatment phase.|8 weeks of treatment|Descriptive statistics were calculated for all enrolled subjects. A full statistical analysis was not performed due to study termination.|||participants|||Number
2635501|NCT01802437|Primary|SAS-SR Score|The SAS-SR provides an understanding of an individual's level of satisfaction with his or her social situation, measuring the level of both behavioral and emotional social adjustment across four major areas (school, friends, family, and dating). Participants answer each item on a scale of 1 to 5. The total score also ranges from 1 to 5 and is the average of all item scores. The total score provides an index of social impairment with higher mean score indicating more difficulties with social adjustment. Lower scores post treatment indicate efficacy of the intervention.|Baseline and 16-weeks||||score on a scale||Standard Error|Mean
2635502|NCT01802437|Primary|CGAS Score|The Children's Global Assessment Scale (CGAS) is a numeric scale used by mental health clinicians to rate the general functioning. Scores range from 1 to 100, with high scores indicating better functioning. A score of 1-10 indicates the need for constant supervision, while a score of 91-100 indicates superior functioning.|Baseline and 16-weeks||||score on a scale||Standard Error|Mean
2635710|NCT01800162|Secondary|Number of Ruptured Ectopic Pregnancies in Each Group|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|Outcome will be assess within 6 weeks of randomization|||||||
2635503|NCT01802437|Primary|CDRS-R Score|The CDRS-R is a clinician-administered semi-structured interview that assesses symptoms of depression experienced during the previous 2-weeks. The first 14 items are rated on the basis of an interview. The remaining 3 items are rated by a clinician on the basis of the child's nonverbal behavior. Items scales are 1 to 5 for sleep, appetite, and speech and 1 to 7 for the remaining 14 items. Total scores are summed and range from 17 to 113, with lower scores indicating normality while higher scores indicate psychopathology. Lower scores post-intervention indicate treatment efficacy.|Baseline and 16-weeks||||score on a scale||Standard Error|Mean
2635504|NCT01802385|Secondary|Event Free Survival|Event free survival of composite events of: death,central nervous system (CNS) cryptococcal-related paradoxical immune reconstitution inflammatory syndrome (IRIS) or culture-positive relapse.|18 weeks||||Participants|||Count of Participants
2635505|NCT01802385|Secondary|Number of Participants Experiencing IRIS OR Relapse|Cumulative incidence of central nervous system (CNS) cryptococcal-related paradoxical immune reconstitution inflammatory syndrome (IRIS) or culture-positive relapse|18 weeks||||Participants|||Count of Participants
2635506|NCT01802385|Secondary|Fungal Clearance as Determined by Early Fungicidal Activity of CDF|To determine whether adjunctive sertraline will lead to a faster rate of fungal clearance from cerebrospinal fluid (CSF), as measured by early fungicidal activity (EFA) of clearance of the Cryptococcus colony forming units (cfu) per mL of CSF per day, compared to standard therapy alone.|14 days||||-log10 CFU/ml/day||95% Confidence Interval|Mean
2635507|NCT01802385|Secondary|Quantitative Neurocognitive Performance Score (QNPZ-8)|Quantitative neurocognitive performance Z-score (QNPZ-8) at 14 weeks. The QNPZ-8 is a mean score of testing of 8 neurocognitive domains. Eqach domain is scaled based on a Z-score where the mean = 0 for the HIV-negative Ugandan population, accounting for age and educational status. Each +1 unit is one standard deviation better than the population norm. Each -1 unit is one standard deviation worse than the population norm.|14 weeks||||score||95% Confidence Interval|Mean
2635508|NCT01802385|Secondary|Center for Epidemiologic Studies in Depression (CES-D) Scale|Center for Epidemiologic Studies in Depression (CES-D) scale at 14 weeks. CES-D scores are based on a 20 item survey with total scores ranging from 0 to 60. Higher scores suggest a greater presence of depressive symptoms. A CES-D score of 16 or higher is interpreted to indicate a risk for depression.|14 weeks||||score on a scale||95% Confidence Interval|Mean
2635509|NCT01802385|Secondary|Count of Participants With Cerebrospinal Fluid Sterility|Number of participants with sterile cerebrospinal fluid at 2 weeks|14 days||||Participants|||Count of Participants
2635510|NCT01802385|Secondary|Safety (Occurence of Adverse Events)|Safety and tolerability of adjunctive sertraline (grade 4-5) adverse reactions|18 weeks||||events|||Number
2635511|NCT01802385|Primary|Survival|18-week survival. The comparison will be between sertraline 400mg group and placebo|18 weeks||||Participants|||Count of Participants
2635512|NCT01802333|Other Pre-specified|Disease-free Survival (DFS)|"To compare the disease-free survival (DFS) between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat.~DFS is calculated for patients who have achieved a CR or CRi (complete response with incomplete blood count recovery) . DFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse.~2-year DFS by arm will be estimated using the Kaplan-Meier method."|DFS assessed for up to 5 years, 2 year DFS reported|Eligible patients|||Proportion of participants||95% Confidence Interval|Number
2635513|NCT01802333|Other Pre-specified|Complete Response (CR) Rate|"To compare the complete response rate between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat.~Complete response is defined as: ANC >= 1,000/mcl, platelet count >= 100,000/mcl, < 5% bone marrow blasts, no Auer rods, no evidence of extramedullary disease (no requirements for marrow cellularity or hemoglobin concentration)"|Up to 5 years|Eligible patients|||Percentage of participants||95% Confidence Interval|Number
2635514|NCT01802333|Other Pre-specified|Overall Survival (OS)|"To compare OS between patients who receive standard 7+3 therapy or IA to patients who receive IA + vorinostat.~OS is calculated for all patients from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.~2-year OS by arm will be estimated using the Kaplan-Meier method."|OS assessed for up to 5 years, 2 year OS reported|Eligible patients|||Proportion of participants||95% Confidence Interval|Number
2635515|NCT01802333|Other Pre-specified|Cytogenetic Risk Distribution of Patients on This Study|To estimate the cytogenetic risk distribution of patients on this study.|Baseline|Eligible patients with known cytogenetic risk at baseline|||percentage of participants|||Number
2635516|NCT01802333|Other Pre-specified|Prevalence of the Mutations IDH1, IDH2, TET2, DMT3A in Patients on This Study|"To estimate the prevalence of these mutations in this patient population.~This objective will be analyzed as funding allows."|Baseline|There was not sufficient funding to test patients for IDH1, IDH2, TET2, or DMT3A. Therefore, this objective was not completed.||||||
2635517|NCT01802333|Other Pre-specified|Prevalence of the Mutation NPM1 in Patients on This Study.|To estimate the prevalence of the mutation NPM1 in this patient population.|Baseline|Eligible patients with known NPM1 status at baseline|||percentage of patients|||Number
2635518|NCT01802333|Secondary|Frequency and Severity of Toxicities|Number of patients with Grade 3-5 adverse events that were possibly, probably or definitely related to study drug are reported by given type of adverse event.|Up to 5 years|Eligible patients who started treatment|||Participants|||Count of Participants
2635519|NCT01802333|Secondary|EFS of Arm I Compared to Arm II|"EFS is calculated for all patients from the date of initial registration on study until the first of the following: death from any cause, relapse from remission (CR or CRi) or completion of protocol Induction/Re-Induction therapy without documentation of CR or CRi.~A two-sided test of the hazard ratio (HR) of 7:3: IA (versus the null hypothesis of HR =1) will be done using a proportional hazards regression model with the stratification factors included as covariates.~2-year EFS by arm will be estimated using the Kaplan-Meier method."|EFS assessed for up to 5 years, 2 year EFS reported|Eligible patients|||Proportion of participants||95% Confidence Interval|Number
2635742|NCT01799720|Secondary|Diastolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the diastolic pressure of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||millimetres of mercury||Standard Error|Mean
2635520|NCT01802333|Secondary|Disease-free Survival (DFS) Among High Risk Patients|"DFS is calculated for patients who have achieved a CR or CRi (complete response with incomplete blood count recovery). DFS will be measured from the date of CR or CRi until relapse from CR or CRi for death from any cause. Observation is censored at the date of last follow-up for patients last known to be alive without report of relapse.~2-year DFS for high risk patients will be estimated using the Kaplan-Meier method."|DFS assessed for up to 5 years, 2 year DFS reported|Eligible, high risk patients, regardless of treatment arm.|||Proportion of participants||95% Confidence Interval|Number
2635521|NCT01802333|Primary|Rate of Allogeneic HCT|The goal of the transplant objective is to determine whether it is possible to conduct allogeneic HCT on 60% or more of adults with high-risk AML in first complete remission (alternative). If 40% or fewer of high-risk patients in CR can be transplanted, the proposed transplant support system will not be considered feasible. A one-sided binomial test compared to the null transplant rate will be conducted.|Up to 5 years|Eligible patients with high-risk AML who achieved CR or CRi, regardless of treatment arm.|||percentage of patients||95% Confidence Interval|Number
2635522|NCT01802333|Primary|Event-free Survival (EFS)|"EFS is calculated for all patients from the date of initial registration on study until the first of the following: death from any cause, relapse from remission (CR or CRi) or completion of protocol Induction/Re-Induction therapy without documentation of CR or CRi.~2-year EFS by arm will be estimated using the Kaplan-Meier method. EFS will be compared between Arm I and Arm III and between Arm II and Arm III using Cox proportional hazards regression."|EFS assessed for up to 5 years, 2 year EFS reported|Eligible patients|||Proportion of participants||95% Confidence Interval|Number
2635523|NCT01802320|Other Pre-specified|Validation of the Enrichment Biomarker Signature in Metastatic Sites|Samples will be analyzed using the Wilcoxon rank test. Chi-square or Fisher's exact test where appropriate will be used to determine whether high levels of marker expression correlate with PTEN status.|Up to 18 months|Given the lack of response seen in this study, biomarker validation and correlation of biomarker enrichment with clinical outcome is not feasible. Data were not collected.||||||
2635524|NCT01802320|Secondary|Progression-free Survival (PFS)|Estimated using the Kaplan and Meier product limit method. Cox proportional hazards regression model will be used to identify prognostic factors for PFS.|From start of treatment to time of progression or death, whichever occurs first, assessed up to 18 months||||months||95% Confidence Interval|Median
2635525|NCT01802320|Secondary|Overall Survival (OS)|Estimated using the Kaplan and Meier product limit method. Cox proportional hazards regression model will be used to identify prognostic factors for OS.|Up to 18 months||||months||95% Confidence Interval|Median
2635526|NCT01802320|Secondary|Duration of Tumor Response (DR)|Estimated using the Kaplan and Meier product limit method. Cox proportional hazards regression model will be used to identify prognostic factors for DR.|From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 18 months|Outcome data not collected, no analysis to be performed as participants had related tumor response.||||||
2635527|NCT01802320|Primary|Overall Response Rate (CR+PR) Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Complete Response (CR): Disappearance all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. Partial Response (PR): > 30% decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): > 20% increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if smallest on study). In addition to relative increase of 20%, sum must demonstrate absolute increase of >5 mm. (Note: appearance of 1/> new lesions also considered progressions). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study.|Up to 18 months||||Participants|||Count of Participants
2635528|NCT01802216|Secondary|Change in Estimated Glomerular Filtration Rate|Using the creatinine-based CKD-EPI equation, the investigators will determine change in estimated glomerular filtration rate from baseline to 12 month by individual and treatment group|Baseline, Month 4, Month 12||||mL/min/1.73m^2||Standard Deviation|Mean
2635529|NCT01802216|Primary|Number of Participants Completing Study Protocol|The investigators will determine the number of participants who complete baseline, month 4, month 8, and month 12 study visits.|Baseline, Month 4, Month 8, Month 12||||Participants|||Count of Participants
2635530|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires|Gastrointestinal Symptom Questionaires (GSRS) was administered during weeks 1, 5, and 6 of the study to evaluate gastrointestinal symptoms. The scale ranges from 1 (no discomfort at all) to 7 (very severe discomfort).|Weeks 1, 5, and 6|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
2635531|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Participants recorded the number of hours they slept on the daily questionnaire.|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||Hours||Standard Error|Mean
2635532|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Daily scores from weeks 2 - 5 were then averaged to arrive at a single value. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
2635533|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
2635534|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
2635535|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
2635536|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
2635537|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
2635538|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
2635539|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
2635540|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
2635541|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
2635542|NCT01802151|Secondary|Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study)|Viability of B. subtilis R0179, recovered from stool samples, was assessed using one way ANOVA followed subsequently by Tukey-Kramer HSD when significance was reached (p<0.05). Data was normalized when appropriate. Data analyzed was log (CFU/g).|6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||log CFU/g||Standard Error|Mean
2635543|NCT01802151|Primary|Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress|Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).|Weekly for 6 weeks|Participants who completed all study requirements were included in the baseline analysis population.|||units on a scale||Standard Error|Mean
2635544|NCT01802073|Primary|Count of Participants With Abnormal MRCP and/or Liver Biopsy at Baseline and With Clinically Significant Improvement at Year 1|Clinically significant improvement was determined by investigator assessment per participant based on their medical history and disease stage. MRCP imaging was abnormal if it included biliary beading, biliary strictures, dilated bile duct, and/or liver fibrosis. Liver pathology was considered abnormal if the biopsy was S1 or greater on the liver fibrosis staging scale (S0 no fibrosis, S1 mild fibrosis, S2 moderate fibrosis, S3 sever fibrosis, S4 cirrhosis).|Baseline; Year 1|Participants with abnormal MRCP and/or liver biopsy at baseline are included in the analysis.|||Participants|||Count of Participants
2635545|NCT01802073|Primary|Count of Participants With Abnormal Liver Biopsies at Baseline and With Clinically Significant Improvement at Year 1|Clinically significant improvement was determined by investigator assessment per participant based on their medical history and disease stage. Liver pathology was considered abnormal if the biopsy was S1 or greater on the liver fibrosis staging scale (S0 no fibrosis, S1 mild fibrosis, S2 moderate fibrosis, S3 sever fibrosis, S4 cirrhosis).|Baseline; Year 1|Participants with abnormal liver biopsy at baseline and who had a post-treatment liver biopsy are included in the analysis.|||Participants|||Count of Participants
2635743|NCT01799720|Secondary|Systolic Pressure (mmHg) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the systolic pressure of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||millimetres of mercury||Standard Error|Mean
2635546|NCT01802073|Primary|Count of Participants With Abnormal Magnetic Resonance Cholangiopancreatography (MRCP) Imaging at Baseline and With Clinically Significant Improvement at Year 1|Clinically significant improvement was determined by investigator assessment per participant based on their medical history and disease stage. MRCP imaging was abnormal if it included biliary beading, biliary strictures, dilated bile duct, and/or liver fibrosis.|Baseline; Year 1|Participants with abnormal MRCP at baseline are included in the analysis.|||Participants|||Count of Participants
2635547|NCT01802073|Primary|Count of Participants With Elevated ALT and/or GGT at Baseline and With Clinically Significant Improvement at Month 3|Clinically significant improvement was determined by investigator assessment per participant based on their medical history and disease stage. Elevated ALT (and GGT) was any value greater than the upper limit of the standard reference range used by patient's laboratory.|Baseline; Month 3|Participants with ALT and/or GGT elevated at baseline are included in the analysis.|||Participants|||Count of Participants
2635548|NCT01802073|Primary|Count of Participants With Elevated Gamma-glutamyltransferase (GGT) at Baseline and With Clinically Significant Improvement at Month 3|Clinically significant improvement was determined by investigator assessment per participant based on their medical history and disease stage. Elevated GGT was any value greater than the upper limit of the standard reference range used by patient's laboratory.|Baseline; Month 3|Participants with GGT elevated at baseline are included in the analysis.|||Participants|||Count of Participants
2635549|NCT01802073|Primary|Count of Participants With Elevated Alanine Aminotransferase (ALT) at Baseline and With Clinically Significant Improvement at Month 3|Clinically significant improvement was determined by investigator assessment per participant based on their medical history and disease stage. Elevated ALT was any value greater than the upper limit of the standard reference range used by patient's laboratory.|Baseline; Month 3|Participants with ALT elevated at baseline are included in the analysis.|||Participants|||Count of Participants
2635550|NCT01801982|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to Month 12|FAS included all enrolled participants.|||participants|||Number
2635551|NCT01801982|Secondary|Overall Survival at Month 24|Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. Number of participants who were alive at Month 24 was to be reported.|Month 24|Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1).||||||
2635552|NCT01801982|Secondary|Overall Survival at Month 12|Overall survival was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. Number of participants who were alive at Month 12 was to be reported.|Month 12|Full Analysis Set (FAS) included all enrolled participants.|||participants|||Number
2635553|NCT01801982|Primary|Number of Participants With Clinically Significant Medical History at Month 24|Criteria for clinically significant medical history included any hospital admissions or any medications given since discharge from Study A1481276 (NCT01069861) that were considered clinically significant by the investigator.|Month 24|Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1).||||||
2635554|NCT01801982|Primary|Number of Participants With Clinically Significant Medical History at Month 12|Criteria for clinically significant medical history included any hospital admissions or any medications given since discharge from Study A1481276 (NCT01069861) that were considered clinically significant by the investigator.|Month 12|Full Analysis Set (FAS) included all enrolled participants.|||participants|||Number
2635555|NCT01801982|Primary|Number of Participants With Physical Examination Abnormalities at Month 24|Physical examinations included height, weight, head circumference, general appearance, skin examination, abdominal examination, respiratory system, neurological examination, hearing and ophthalmology assessments. Physical examination abnormalities were based on investigator discretion.|Month 24|Data was not possible to report as participant lost to follow-up at Month 24 (Visit 2) after Month 12 follow-up (Visit 1).||||||
2635556|NCT01801982|Primary|Number of Participants With Physical Examination Abnormalities at Month 12|Physical examinations included height, weight, head circumference, general appearance, skin examination, abdominal examination, respiratory system, neurological examination, hearing and ophthalmology assessments. Physical examination abnormalities were based on investigator discretion.|Month 12|Full Analysis Set (FAS) included all enrolled participants.|||participants|||Number
2635557|NCT01801917|Secondary|BAF312 Trough Plasma Concentrations (PK Set)|All blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. For each sample, approximately 2 mL of blood was drawn. BAF312 was determined in ethylenediaminetetraacetic acid (EDTA) plasma using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) bioanalytical method for the quantification. The anticipated lower limit of quantification (LLOQ) was 0.02 ng/mL using 0.1 mL of plasma|-7 Baseline, day 28, 56, 84|P|||ng/mL||Standard Deviation|Mean
2635558|NCT01801917|Secondary|Six-minute Walking Distance (6MWD) at Week 24|This test assessed the distance a patient could walk in 6 minutes (Rutkove et al 2002). If the patient was not able to walk for 6 minutes then a 2 minute walking test was conducted|Baseline, 24 weeks|Pharmacodynamic (PD) included patients with PD data and no major protocol deviations|||meters||Standard Deviation|Mean
2635559|NCT01801917|Secondary|Six-minute Walking Distance (6MWD) at Week 12|This test assessed the distance a patient could walk in 6 minutes (Rutkove et al 2002). If the patient was not able to walk for 6 minutes then a 2 minute walking test was conducted|Baseline, 12 weeks|Pharmacodynamic (PD) included patients with PD data and no major protocol deviations|||meters||Standard Deviation|Mean
2635560|NCT01801917|Primary|Percent Change From Baseline at Week 12 for BAF312 2 mg, 10 mg or Placebo (Once Daily) Serum Creatine Kinase (CK) Levels|Serum creatine kinase (CK) were analyzed as part of the blood chemistry panel. Posterior credibility interval from Bayesian analysis displayed as confidence interval. The variable CK was log-transformed for statistical analysis and after estimation was converted to percent change from baseline divided by the mean baseline|Baseline, at 12 weeks|Pharmacodynamic (PD) included patients with PD data and no major protocol deviations|||U/L||90% Confidence Interval|Mean
2635561|NCT01801917|Primary|Change From Baseline at Week 12 for BAF312 2 mg, 10 mg or Placebo (Once Daily) for Combined Efficacy Endpoint: Manual Muscle Testing in 24 Muscles (MMT24)|Manual Muscle Testing Scoring Sheet: Neck flexors, neck extensors and other designated muscles bilaterally (Biceps brachii, Deltoid middle, Quadriceps, Gluteus maximus, Gluteus medius, Trapezius, Iliopsoas, Hamstrings, Wrist extensors, Wrist Flexors, Ankle plantar flexors and Ankle dorsiflexors) were tested on a 0-10 scale by the Investigator. Posterior credibility interval from Bayesian analysis displayed as confidence interval. The scores range was 0 to 260. Higher scores indicate better outcome.|Baseline, at 12 weeks|Pharmacodynamic (PD) included patients with PD data and no major protocol deviations|||scores on a scale||90% Confidence Interval|Mean
2635562|NCT01801735|Primary|Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination|The safety of Meloxicam 10 mg was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, serious adverse events, treatment-related TEAEs, and adverse events (AEs) leading to discontinuation and subjects who died.|Baseline to Week 52/Early Termination||||participants|||Number
2635563|NCT01801475|Primary|Metabolic Clearance of Ondasetron|This is a mathematical estimation of the clearance for ondasetron as calculated by NONMEM.|8 hours for women; 48 hours for neonate.|All patient data was used in the estimation process.|||L/hr||95% Confidence Interval|Mean
2635564|NCT01801475|Primary|Volume of Distribution Estimated Pharmacokinetic Parameter|This is an estimated pharmacokinetic parameter as calculated by NONMEM.|8 hours for women; 48 hours for neonate.|All subjects but not possible for neonates|||Liters||95% Confidence Interval|Mean
2635565|NCT01801449|Primary|Number of Subjects Who Maintained Inflammatory Remission With Rilonacept|Inflammatory remission criteria remission criteria were defined as meeting all of the following criteria: a diary score of <0.5 (reflecting no fever, skin rash or bone pain), normal acute phase reactants (C-reactive protein (CRP) <0.5 mg/dL), no objective skin rash or radiological evidence of active bone lesions on x-ray.|6 months|Analysis included all subjects|||Participants|||Count of Participants
2635566|NCT01801449|Secondary|Pediatric Quality of Life Inventory (PedsQL)|Pediatric Quality of Life Inventory (PedsQL)-assess functional impairment and change in treatment and health-related quality of life respectively. Responses on this scale are transformed into a 0-100 scale, with 0 being the worst value for health-related quality of life and 100 being the best possible value for health-related quality of life.|Baseline|Analysis included all subjects|||Units on a scale||Standard Deviation|Mean
2635567|NCT01801449|Secondary|Pediatric Quality of Life Inventory (PedsQL)|Pediatric Quality of Life Inventory (PedsQL)-assess functional impairment and change in treatment and health-related quality of life respectively. Responses on this scale are transformed into a 0-100 scale, with 0 being the worst value for health-related quality of life and 100 being the best possible value for health-related quality of life.|24 months after rilonacept initiation|Analysis included all subjects|||Units on a scale||Standard Deviation|Mean
2635568|NCT01801449|Secondary|Dual-energy X-ray Absorptiometry (DEXA) Scores|Mean z-scores of anteroposterior lumbar (AP) spine were used for comparisons|Baseline|Analysis included all subjects|||z-score||Standard Deviation|Mean
2635569|NCT01801449|Secondary|Dual-energy X-ray Absorptiometry (DEXA) Scores|Mean z-scores of anteroposterior lumbar (AP) spine were used for comparisons|12 months after rilonacept initiation|Analysis included all subjects|||z-score||Standard Deviation|Mean
2635570|NCT01801449|Secondary|Childhood Health Assessment Questionnaire (CHAQ)|The Childhood Health Assessment Questionnaire (CHAQ) is a patient self-assessment (or parent assessment) tool for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3). The scores are summed and divided by the number of total categories answered to arrive at a final value.|Baseline|Analysis included all subjects|||Units on a scale||Standard Deviation|Mean
2635571|NCT01801449|Secondary|Childhood Health Assessment Questionnaire (CHAQ)|The Childhood Health Assessment Questionnaire (CHAQ) is a patient self-assessment (or parent assessment) tool for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3). The scores are summed and divided by the number of total categories answered to arrive at a final value.|24 months after rilonacept initiation|Analysis included all subjects|||Units on a scale||Standard Deviation|Mean
2635572|NCT01801449|Secondary|Weight|Antropometric measurements - Weight z-score|Baseline|Analysis included all subjects|||z-score||Standard Deviation|Mean
2635573|NCT01801449|Secondary|Weight|Antropometric measurements - Weight z-score|24 months after rilonacept initiation|Analysis included all subjects|||z-score||Standard Deviation|Mean
2635574|NCT01801449|Secondary|Height|Antropometric measurements - Height z-score|Baseline|Analysis included all subjects|||z-score||Standard Deviation|Mean
2635575|NCT01801449|Secondary|Height|Antropometric measurements - Height z-score|24 months after rilonacept initiation|Analysis included all subjects|||z-score||Standard Deviation|Mean
2635576|NCT01801436|Primary|Volume of Distribution at Steady-State (Vss) of Bortezomib on Day 11 of Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Liter||Standard Deviation|Mean
2635711|NCT01800162|Primary|Frequency of Clinical Resolution for the 3 Different Management Arms for a Persisting PUL.|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.|Outcome will be assessed within 6 weeks of randomization|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.||||||
2635577|NCT01801436|Primary|Volume of Distribution at Steady-State (Vss) of Bortezomib on Day 1 of Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Liter||Standard Deviation|Mean
2635578|NCT01801436|Primary|Systemic Clearance (CL) of Bortezomib on Day 11 of Cycle 1|Systemic CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma AUC(0-infinity).|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Liter per Hour||Standard Deviation|Mean
2635579|NCT01801436|Primary|Systemic Clearance (CL) of Bortezomib on Day 1 of Cycle 1|Systemic CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the plasma AUC(0-infinity).|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Liter per Hour||Standard Deviation|Mean
2635580|NCT01801436|Primary|Mean Residence Time (MRT) of Bortezomib in the Body on Day 11 of Cycle 1|The MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(infinity)/AUC(infinity) where AUMC(infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC(infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hour||Standard Deviation|Mean
2635581|NCT01801436|Primary|Mean Residence Time (MRT) of Bortezomib in the Body on Day 1 of Cycle 1|The MRT is the average time at which the number of absorbed molecules reside in the body, after single-dose administration, and calculated as AUMC(infinity)/AUC(infinity) where AUMC(infinity) is area under the plasma concentration-time first moment curve from time zero to infinite time and AUC(infinity) is the area under the plasma concentration-time curve from time zero to infinite time.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hour||Standard Deviation|Mean
2635582|NCT01801436|Primary|Area Under First Moment Plasma Concentration-Time Curve (AUMC) of Bortezomib on Day 11 of Cycle 1|AUMC is defined as the area under first moment plasma concentration-time curve from time of dosing up to definite time t, to infinity, or to the time of last measurable concentration determined by the following equation: AUMC(0 to infinity)=Cntn/k elimination(el) + Cn/k(el^2) summation[(tn - tn^-1) (Cn^-1) (tn^-1)] + Cntn/2 where Cn=last quantifiable concentration, tn=time at which Cn is measured, k=rate constant.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hour square*ng per ml||Standard Deviation|Mean
2635583|NCT01801436|Primary|Area Under First Moment Plasma Concentration-Time Curve (AUMC) of Bortezomib on Day 1 of Cycle 1|AUMC is defined as the area under first moment plasma concentration-time curve from time of dosing up to definite time t, to infinity, or to the time of last measurable concentration determined by the following equation: AUMC(0 to infinity)=Cntn/k elimination(el) + Cn/k(el^2) summation[(tn - tn^-1) (Cn^-1) (tn^-1)] + Cntn/2 where Cn=last quantifiable concentration, tn=time at which Cn is measured, k=rate constant.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hour square*ng per ml||Standard Deviation|Mean
2635584|NCT01801436|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Bortezomib on Day 11 of Cycle 1|The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hour*ng per ml||Standard Deviation|Mean
2635585|NCT01801436|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Bortezomib on Day 1 of Cycle 1|The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), in which C(last) is the last observed quantifiable concentration.|Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hour*ng per ml||Standard Deviation|Mean
2635643|NCT01801111|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to Tlast (AUC[0-last]) of Alectinib|The AUC(0-last) of alectinib was calculated using the linear trapezoidal rule and actual sampling times (with the exception of pre-dose which was set to zero).|Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1|Analysis was performed on PK Evaluable Population. Here, ‘Number Analyzed’=number of participant evaluable for specified category.|||hrs*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2635586|NCT01801436|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC[0-t]) of Bortezomib on Day 11 of Cycle 1|The AUC(0-t) is area under the plasma concentration-time curve from zero to the last quantifiable concentration determined by the trapezoidal rule.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hour*ng per mL||Standard Deviation|Mean
2635587|NCT01801436|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC[0-t]) of Bortezomib on Day 1 of Cycle 1|The AUC(0-t) is area under the plasma concentration-time curve from time zero to the last quantifiable concentration determined by the trapezoidal rule.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hour*ng per ml||Standard Deviation|Mean
2635588|NCT01801436|Primary|Terminal Rate Constant (Lambda[z]) of Bortezomib on Day 11 of Cycle 1|Lambda(z) is defined as terminal rate-constant which reflect the speed of drug elimination in vivo (within the living), and is estimated by log-linear regression analysis of the terminal phase of the plasma concentration versus time curve for at least 3 points.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Per Hour||Standard Deviation|Mean
2635589|NCT01801436|Primary|Terminal Rate Constant (Lambda[z]) of Bortezomib on Day 1 of Cycle 1|Lambda(z) is defined as terminal rate-constant which reflect the speed of drug elimination in vivo (within the living), and is estimated by log-linear regression analysis of the terminal phase of the plasma concentration versus time curve for at least 3 points.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Per Hour||Standard Deviation|Mean
2635590|NCT01801436|Primary|Elimination Half-Life Period (T1/2) of Bortezomib on Day 11 of Cycle 1|The T1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal rate-constant (lambda[z]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hours||Standard Deviation|Mean
2635591|NCT01801436|Primary|Elimination Half-Life Period (T1/2) of Bortezomib on Day 1 of Cycle 1|The T1/2 is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal rate-constant (lambda[z]) of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hours||Standard Deviation|Mean
2635592|NCT01801436|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bortezomib on Day 11 of Cycle 1|Tmax is the time when Cmax is observed, taken directly from the plasma concentration-time profile.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hours||Standard Deviation|Mean
2635593|NCT01801436|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Bortezomib on Day 1 of Cycle 1|Tmax is the time when Cmax is observed, taken directly from the plasma concentration-time profile.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Hours||Standard Deviation|Mean
2635594|NCT01801436|Primary|Maximum Observed Plasma Concentration (Cmax) of Bortezomib on Day 11 of Cycle 1|The Cmax is observed maximum plasma concentration, taken directly from the plasma concentration-time profile.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1|The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||ng per ml||Standard Deviation|Mean
2635595|NCT01801436|Primary|Maximum Observed Plasma Concentration (Cmax) of Bortezomib on Day 1 of Cycle 1|The Cmax is observed maximum plasma concentration, taken directly from the plasma concentration-time profile.|0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 1 of Cycle 1|The Per-protocol (PP) population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.|||Nanogram per millileter (ng per ml)||Standard Deviation|Mean
2635596|NCT01801436|Primary|Number of Participants With KPS Score at Day 11 of Cycle 8|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 11 of Cycle 8|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data.|||Participants|||Number
2635712|NCT01799993|Other Pre-specified|Number of Death Due to Any Reason Through Day 10 and Day 15|Number of deaths due to any reason through Day 10 and Day 15 were summarized for each treatment group.|Up to 10 days and 15 days after start of study treatment, respectively|mITT population|||Participants|||Count of Participants
2635597|NCT01801436|Primary|Number of Participants With KPS Score at Day 1 of Cycle 7|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 1 of Cycle 7|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.|||Participants|||Number
2635598|NCT01801436|Primary|Number of Participants With KPS Score at Day 1 of Cycle 5|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 1 of Cycle 5|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.|||Participants|||Number
2635599|NCT01801436|Primary|Number of Participants With KPS Score at Day 1 of Cycle 3|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 1 of Cycle 3|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.|||Participants|||Number
2635600|NCT01801436|Primary|Number of Participants With KPS Score at Day 1 of Cycle 1|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Day 1 of Cycle 1|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data.|||Participants|||Number
2635601|NCT01801436|Primary|Number of Participants With Karnofsky Performance Status (KPS) Score at Baseline|The KPS Index allows participants to be classified as per their functional impairment (abnormal function). This can be used to compare effectiveness of different therapies (medicine or medical care given to a participant for a disease or condition) and to assess the prognosis (outlook, probable outcomes) in individual participants. KPS was recorded on an 11-point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100.) where '0=Dead' and '100=Normal, no complaints, no evidence of disease'. The lower the Karnofsky score, the worse the survival for most serious illnesses.|Baseline|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data.|||Participants|||Number
2635602|NCT01801436|Primary|Number of Participants With Response to Treatment at Day 11 of Cycle 8|Response to treatment was based on the changes in monoclonal protein (M-protein) in serum and urine. Response categories were complete response: complete clearance of M-protein for at least 6 weeks, response: at least 75 percent reduction in M-protein for at least 2 determinations 6 weeks apart, partial response: 50 to 74 percent reduction in M-protein, minimal response: 25 to 49 percent reduction in M-protein, stable disease: not qualifying minimal response or progression and progression: increased M-protein level in serum or urine or clinical signs of disease progression.|Day 11 of Cycle 8|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data.|||Participants|||Number
2635603|NCT01801436|Primary|Number of Participants With Response to Treatment at Day 1 of Cycle 7|Response to treatment was based on the changes in monoclonal protein (M-protein) in serum and urine. Response categories were complete response: complete clearance of M-protein for at least 6 weeks, response: at least 75 percent reduction in M-protein for at least 2 determinations 6 weeks apart, partial response: 50 to 74 percent reduction in M-protein, minimal response: 25 to 49 percent reduction in M-protein, stable disease: not qualifying minimal response or progression and progression: increased M-protein level in serum or urine or clinical signs of disease progression.|Day 1 of Cycle 7|The FAS population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.|||Participants|||Number
2635604|NCT01801436|Primary|Number of Participants With Response to Treatment at Day 1 of Cycle 5|Response to treatment was based on the changes in monoclonal protein (M-protein) in serum and urine. Response categories were complete response: complete clearance of M-protein for at least 6 weeks, response: at least 75 percent reduction in M-protein for at least 2 determinations 6 weeks apart, partial response: 50 to 74 percent reduction in M-protein, minimal response: 25 to 49 percent reduction in M-protein, stable disease: not qualifying minimal response or progression and progression: increased M-protein level in serum or urine or clinical signs of disease progression.|Day 1 of Cycle 5|The full analysis set (FAS) population included all the participants who received 1 dose of study medication and had post-dose efficacy data. Here ‘N’ signifies those participants who were evaluated for this outcome measures.|||Participants|||Number
2635605|NCT01801358|Secondary|Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||hr||Full Range|Median
2635606|NCT01801358|Secondary|Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2635607|NCT01801358|Secondary|Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||hr*ng/ml||Geometric Coefficient of Variation|Geometric Mean
2635608|NCT01801358|Secondary|Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||hr||Full Range|Median
2635609|NCT01801358|Secondary|Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2635610|NCT01801358|Secondary|Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||hr*ng/ml||Geometric Coefficient of Variation|Geometric Mean
2635611|NCT01801358|Secondary|Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||hr||Full Range|Median
2635612|NCT01801358|Secondary|Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2635613|NCT01801358|Secondary|Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 15)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 15)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||hr*ng/ml||Geometric Coefficient of Variation|Geometric Mean
2635614|NCT01801358|Secondary|Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||hr||Full Range|Median
2635615|NCT01801358|Secondary|Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2635616|NCT01801358|Secondary|Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 1)|Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.|Cycle 1 (Day 1)|This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.|||hr*ng/ml||Geometric Coefficient of Variation|Geometric Mean
2635644|NCT01801111|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to 10 Hours Post-dose (AUC[0-10]) of Alectinib|The AUC(0-10) of alectinib was calculated using the linear trapezoidal rule and actual sampling times (with the exception of pre-dose which was set to zero).|Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1|Analysis was performed on PK Evaluable Population. Here, ‘Number Analyzed’=number of participant evaluable for specified category.|||hrs*nanograms per milliliter (hrs*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2635617|NCT01801358|Secondary|Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Survival (OS)|"Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.~Overall survival (OS) is defined as the time from date of randomization/start of treatment to date of death due to any cause.~Due to an enrollment halt, the Phase II part of the study was not conducted."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.||||||
2635618|NCT01801358|Secondary|Phase II: Evaluation of Preliminary Anti-tumor Activity - Duration of Response (DOR)|"Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.~Duration of Response is not reported, due to the enrollment halt, which occurred prior to Phase II of the study."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.||||||
2635619|NCT01801358|Secondary|Phase II: Evaluation of Preliminary Anti-tumor Activity - Best Overall Response (BOR)|"Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.~The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for Progressive Disease (PD) the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.~Due to an enrollment halt, the Phase II part of the study was not conducted."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.||||||
2635620|NCT01801358|Secondary|Phase II: Evaluation of Preliminary Anti-tumor Activity - Overall Response Rate (CR+PR)|"Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone.~Overall response rate (ORR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR). This is also referred to as 'Objective response rate' in some protocols or publications.~Due to an enrollment halt, the Phase II part of the study was not conducted."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.||||||
2635621|NCT01801358|Secondary|Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Progression Free Survival (PFS)|"Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.~PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause."|Cycle 1 (up to 28 days)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.|||weeks||Inter-Quartile Range|Median
2635622|NCT01801358|Secondary|Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Duration of Response (DOR)|"Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.~Duration of Response (DOR) is not reported, since there were no responses of Complete Response (CR) or Partial Response (PR) at any time during the study."|Cycle 1 (up to 28 days)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.||||||
2635623|NCT01801358|Secondary|Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Best Overall Response (BOR)|"Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination.~The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria."|Cycle 1 (up to 28 days)|Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.|||participants|||Number
2635624|NCT01801358|Secondary|Phase Ib/II: The Number of Subjects Experiencing At Least One Serious Adverse Event (SAE)|"Serious adverse event (SAE) is defined as one of the following:~Is fatal or life-threatening~Results in persistent or significant disability/incapacity~Constitutes a congenital anomaly/birth defect~Is medically significant~Requires inpatient hospitalization or prolongation of existing hospitalization~Note that hospitalizations for the following reasons should not be reported as serious adverse events:~Routine treatment or monitoring of the studied indication, not associated with any deterioration in condition~Elective or pre-planned treatment for a pre-existing condition that is unrelated to metastatic uveal melanoma and has not worsened since signing the informed consent~Social reasons and respite care in the absence of any deterioration in the patient's general condition"|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.|||participants|||Number
2635625|NCT01801358|Secondary|Phase Ib/II: The Number of Subjects Experiencing At Least One Adverse Event (AE)|An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|Analysis group consists of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.|||participants|||Number
2635626|NCT01801358|Primary|Phase II: Progression Free Survival (PFS)|"The time from date of randomization to the date of event defined as the first documented progression or death due to any cause.~Due to an enrollment halt, the Phase II part of the study was not conducted. The sponsor decided to permanently stop recruitment for the study prior to MTD determination."|From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)|||||||
2635627|NCT01801358|Primary|Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle|A DLT is defined as an adverse event or abnormal laboratory value as defined in the protocol that is assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with AEB071 and MEK162.|Cycle 1 (up to 28 days)|Analysis is comprised of the Dose-determining Set, which is all patients from the safety set who either met the minimum exposure criterion below and had sufficient safety evaluations during Cycle 1, or discontinued earlier due to DLT during Cycle 1.|||DLTs|||Number
2635628|NCT01801280|Primary|Dose-normalized AUC of Mycophenolic Acid|"Bioavailability (12h AUC) of mycophenolic acid in renal transplant patients after administration of MMF+/-PAN and EC-MPS+/-PAN~For evaluation of pharmacokinetic and pharmacodynamic parameters blood will be collected before, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h after drug intake."|Study duration for each patient: 2 months. After 10-14 days of drug intake blood samples for PK/PD analysis will be collected. On the next day new treatment starts. There are 4 study visits at the study center. Duration will be approximately 12hours||||mg*h/L||Standard Deviation|Mean
2635629|NCT01801124|Secondary|The Safety of EXPAREL Will be Assessed by the Occurrence of All Postsurgical AEs and SAEs Through Day 30.|Adverse events and serious adverse events through Day 30 will be examined in order to assess the safety of EXPAREL.|30 days|The analysis population comprised all enrolled subjects.|||participants|||Number
2635630|NCT01801124|Primary|The Effectiveness of Abdominal Analgesia From the Infiltration Into the TAP as Measured by the Subject's Overall Postsurgical Analgesic Use|The effectiveness of abdominal analgesia from the infiltration into the TAP as measured by the subject's overall postsurgical analgesic use in morphine equivalents (mg)|10 days|The analysis population comprised all enrolled subjects.|||mg (morphine equivalents)||Standard Deviation|Mean
2635631|NCT01801111|Secondary|Accumulation Ratio of Alectinib Metabolite|Accumulation ratio after repeat dosing was computed as AUC(0-10) on Day 21 divided by AUC(0-10) on Day 1.|Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hours post-dose on Day 1 and Day 21 of Cycle 1|Analysis was performed on PK Evaluable Population. Here, ‘Overall Number of Participants Analyzed’=number of participant evaluable for this outcome measure.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2635632|NCT01801111|Secondary|Accumulation Ratio of Alectinib|Accumulation ratio after repeat dosing was computed as AUC(0-10) on Day 21 divided by AUC(0-10) on Day 1.|Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hours post-dose on Day 1 and Day 21 of Cycle 1|Analysis was performed on PK Evaluable Population. Here, ‘Overall Number of Participants Analyzed’=number of participant evaluable for this outcome measure.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2635633|NCT01801111|Secondary|Peak to Trough Ratio of Alectinib||Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hours post-dose on Day 21 of Cycle 1|Analysis was performed on PK Evaluable Population. Here, ‘Overall Number of Participants Analyzed’=number of participant evaluable for this outcome measure.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2635634|NCT01801111|Secondary|Ctrough of Alectinib Metabolite||Pre-dose (0 hrs) on Day 21 of Cycle 1|Analysis was performed on PK Evaluable Population. Here, ‘Overall Number of Participants Analyzed’=number of participant evaluable for this outcome measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2635635|NCT01801111|Secondary|Trough Plasma Concentration (Ctrough) of Alectinib||Pre-dose (0 hrs) on Day 21 of Cycle 1|Analysis was performed on PK Evaluable Population. Here, ‘Overall Number of Participants Analyzed’=number of participant evaluable for this outcome measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2635636|NCT01801111|Secondary|Metabolite to Parent Ratio Based on AUC(0-last)|Metabolite to parent ratio based on AUC(0-last) was computed as AUC(0-last) of metabolite divided by AUC(0-last) of parent drug (alectinib) corrected for the molecular weight of parent divided by the molecular weight of the metabolite.|Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1|Analysis was performed on PK Evaluable Population. Here, ‘Number Analyzed’=number of participant evaluable for specified category.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2635637|NCT01801111|Secondary|Metabolite to Parent Ratio Based on AUC(0-10)|Metabolite to parent ratio based on AUC(0-10) was computed as AUC(0-10) of metabolite divided by AUC(0-10) of parent drug (alectinib) corrected for the molecular weight of parent divided by the molecular weight of the metabolite.|Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1|Analysis was performed on PK Evaluable Population. Here, ‘Number Analyzed’=number of participant evaluable for specified category.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2635638|NCT01801111|Secondary|AUC(0-last) of Alectinib Metabolite|The AUC(0-last) of alectinib metabolite was calculated using the linear trapezoidal rule and actual sampling times (with the exception of pre-dose which was set to zero).|Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1|Analysis was performed on PK Evaluable Population. Here, ‘Number Analyzed’=number of participant evaluable for specified category.|||hrs*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2635639|NCT01801111|Secondary|AUC(0-10) of Alectinib Metabolite|The AUC(0-10) of alectinib metabolite was calculated using the linear trapezoidal rule and actual sampling times (with the exception of pre-dose which was set to zero).|Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1|Analysis was performed on PK Evaluable Population. Here, ‘Number Analyzed’=number of participant evaluable for specified category.|||hrs*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2635640|NCT01801111|Secondary|Tlast of Alectinib Metabolite|Tlast for alectinib metabolite was estimated from plasma concentration versus time data by non-compartmental methods of analysis using Phoenix WinNonlin v6.2 software.|Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1|Analysis was performed on PK Evaluable Population. Here, ‘Number Analyzed’=number of participant evaluable for specified category.|||hrs||Geometric Coefficient of Variation|Geometric Mean
2635641|NCT01801111|Secondary|Tmax of Alectinib Metabolite|Tmax for alectinib metabolite was estimated from plasma concentration versus time data by non-compartmental methods of analysis using Phoenix WinNonlin v6.2 software.|Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1|Analysis was performed on PK Evaluable Population. Here, ‘Number Analyzed’=number of participant evaluable for specified category.|||hrs||Full Range|Median
2635645|NCT01801111|Secondary|Time to Last Measurable Plasma Concentration (Tlast) of Alectinib|Tlast for alectinib was estimated from plasma concentration versus time data by non-compartmental methods of analysis using Phoenix WinNonlin v6.2 software.|Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1|Analysis was performed on PK Evaluable Population. Here, ‘Number Analyzed’=number of participant evaluable for specified category.|||hrs||Geometric Coefficient of Variation|Geometric Mean
2635646|NCT01801111|Secondary|Time to Cmax (Tmax) of Alectinib|Tmax for alectinib was estimated from plasma concentration versus time data by non-compartmental methods of analysis using Phoenix WinNonlin v6.2 software.|Pre-dose (0 hrs), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1|Analysis was performed on PK Evaluable Population. Here, ‘Number Analyzed’=number of participant evaluable for specified category.|||hrs||Full Range|Median
2635647|NCT01801111|Secondary|Maximum Observed Plasma Concentration (Cmax) of Alectinib|Cmax for alectinib was estimated from plasma concentration versus time data by non-compartmental methods of analysis using Phoenix WinNonlin v6.2 (Pharsight Corporation) software.|Pre-dose (0 hours [hrs]), and 0.5, 1, 2, 4, 6, 8, 10, 12 hrs post-dose on Day 1 and Day 21 of Cycle 1|Analysis was performed on Pharmacokinetic (PK) Evaluable Population, which included all participants who received any dose of alectinib and who had at least one post-baseline PK sample available. Here, ‘Number Analyzed’=number of participant evaluable for specified category.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2635648|NCT01801111|Secondary|Percentage of Participants With CNS Progression as Assessed by IRC According to RECIST v 1.1|According to RECIST v 1.1, CNS progression was defined as >/=20% increase in the SoD of measurable CNS lesions (with an absolute increase of at least 5 mm), taking as reference the baseline SoD; 1 or more new CNS lesion(s); and/or unequivocal progression of non-measurable CNS lesions.|Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up until cutoff 18 August 2014 (up to approximately 53 weeks)|Analysis was performed on safety population.|||percentage of participants|||Number
2635649|NCT01801111|Secondary|CDoR as Assessed by IRC According to RANO Criteria|CDoR: time from the CNS objective response until CNS progression as assessed by IRC according to RANO criteria or death from any cause. CR: complete disappearance of all enhancing measurable, non-measurable disease; stable/improved non-enhancing lesions; no new lesions; no corticosteroids, and clinically stable/improved. PR: >/=50% decrease compared to screening in SPD of enhancing measurable lesions; no progression of non-measurable disease; no new lesions; no corticosteroids, and clinically stable/improved. Progression: >/=25% increase in SPD of enhancing measurable lesions compared to best response on study; stable/increasing doses of corticosteroids; significant increase in non-enhancing lesions not caused by co-morbid events; any new lesions; progression of non-measurable disease; or clinical deterioration not attributable to other non-tumor causes. CDoR was estimated by Kaplan-Meier method and 95% CI was assessed using method of Brookmeyer and Crowley.|Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up until cutoff 18 August 2014 (up to approximately 53 weeks)|Analysis was performed on safety population participants with measurable CNS lesions at baseline and who had CNS objective response as assessed by IRC according to RANO criteria.|||months||95% Confidence Interval|Median
2635650|NCT01801111|Secondary|CNS Duration of Response (CDoR) as Assessed by IRC According to RECIST v1.1|CDoR was defined as the time from the first observation of a CNS objective response (CR or PR) until first observation of CNS progression as assessed by IRC according to RECIST v 1.1 or death from any cause. CR: disappearance of all CNS lesions. PR: >/=30% decrease in the SoD of measurable CNS lesions (taking as reference the baseline SoD). CNS progression: >/=20% increase in the SoD of measurable CNS lesions (with an absolute increase of at least 5 mm), taking as reference the baseline SoD; 1 or more new CNS lesion(s); and/or unequivocal progression of non-measurable CNS lesions. CDoR was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley.|Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years)|Analysis was performed on safety population participants with measurable CNS lesions at baseline and who had CNS objective response as assessed by IRC according to RECIST v1.1.|||months||95% Confidence Interval|Median
2635651|NCT01801111|Secondary|Percentage of Participants Achieving CNS Objective Response as Assessed by IRC According to Radiology Assessment in Neuro-Oncology (RANO) Criteria|CNS response was assessed by IRC according to RANO criteria. CNS Objective response: percentage of participants with a CR or PR that was confirmed by repeat assessments >/=4 weeks after initial documentation. CR was defined as complete disappearance of all enhancing measurable, non-measurable disease; stable or improved non-enhancing lesions; no new lesions; no corticosteroids (or only physiologic replacement dose), and clinically stable or improved. PR was defined as >/=50% decrease compared to screening in the sum of the products of the diameters (SPD) of enhancing measurable lesions; no progression of non-measurable disease (enhancing and non-enhancing lesions); no new lesions; no corticosteroids (or only physiologic replacement dose), and clinically stable or improved. The 95% CI was computed using Clopper-Pearson method.|Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator; then survival follow-up until cutoff 18 August 2014 (up to approximately 53 weeks)|Analysis was performed on safety population participants with measurable CNS lesions at baseline.|||percentage of participants||95% Confidence Interval|Number
2635652|NCT01801111|Secondary|Percentage of Participants Achieving Central Nervous System (CNS) Objective Response as Assessed by IRC According to RECIST v1.1|CNS response was assessed by IRC according to RECIST v1.1. CNS Objective response was defined as percentage of participants with a CR or PR. CR was defined as disappearance of all CNS lesions. PR was defined as >/=30% decrease in the SoD of measurable CNS lesions (taking as reference the baseline SoD). The 95% CI was computed using Clopper-Pearson method.|Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years)|Analysis was performed on safety population participants with measurable CNS lesions at baseline.|||percentage of participants||95% Confidence Interval|Number
2671474|NCT01475955|Secondary|Complete Clearance Rate|The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 8||||participants|||Number
2635653|NCT01801111|Secondary|Percentage of Participants Achieving CR, PR or Stable Disease (SD) According to RECIST v1.1 in RE Population|The disease control rate (DCR) was defined as the percentage of participants achieving CR, PR, or SD that lasted for at least 16 weeks. Tumor response was assessed by the investigator and IRC according to RECIST v1.1. CR: disappearance of all target, non-target lesions; normalization of tumor marker level; and reduction in all lymph nodes size to <10 mm. PR: >/=30% decrease in the SoD of target lesions (taking as reference the baseline SoD). PD: >/=20% relative increase and >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SoD while on study. The 95% CI was computed using Clopper-Pearson method.|Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years)|Analysis was performed on RE population which included all participants with measurable disease at baseline, who had baseline tumor assessment, and who received at least one dose of alectinib. Here, ‘Number Analyzed’=number of participant evaluable for specified category.|||percentage of participants||95% Confidence Interval|Number
2635654|NCT01801111|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death. OS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. Participants who did not die were censored at the date last known to be alive.|Baseline up to death from any cause (up to approximately 4 years)|Analysis was performed on safety population.|||months||95% Confidence Interval|Median
2635655|NCT01801111|Secondary|Percentage of Participants Who Died of Any Cause|Percentage of participants who died of any cause was reported.|Baseline up to death from any cause (up to approximately 4 years)|Analysis was performed on safety population.|||percentage of participants|||Number
2635656|NCT01801111|Secondary|Progression Free Survival (PFS) as Assessed by IRC in Safety Population|PFS was defined as the time interval between the date of the first treatment and the date of PD or death from any cause, whichever occurred first. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-target lesions. PFS was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. Participants who neither progressed nor died at the time of assessment or who were lost to follow-up were censored at the date of the last tumor assessment. Participants with no post-baseline assessments were censored at the date of first dose.|Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years)|Analysis was performed on safety population.|||months||95% Confidence Interval|Median
2635657|NCT01801111|Secondary|Percentage of Participants With PD as Assessed by IRC According to RECIST v1.1 or Death From Any Cause in Safety Population|According to RECIST v1.1, PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-target lesions.|Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years)|Analysis was performed on safety population.|||percentage of participants|||Number
2635658|NCT01801111|Secondary|Duration of Response (DoR) as Assessed by IRC in RE Population|DoR was defined as the time from the first observation of an objective tumor response (CR or PR) until first observation of progressive disease (PD) according to RECIST v1.1 or death from any cause. CR: disappearance of all target, non-target lesions; normalization of tumor marker level; and reduction in all lymph nodes size to <10 mm. PR: >/=30% decrease in the SoD of target lesions (taking as reference the baseline SoD). PD: >/=20% relative increase and >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-target lesions. Duration of response was estimated by Kaplan-Meier method and 95% CI was assessed using the method of Brookmeyer and Crowley. Participants who did not progress or die after a confirmed objective response were censored at the date of their last tumor assessment.|Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years)|Analysis was performed on RE population (IRC) participants with documented objective response as assessed by IRC according to RECIST v1.1.|||months||95% Confidence Interval|Median
2635659|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in Chemotherapy-Naive Participants|Tumor response was assessed by the investigator according to RECIST v1.1. Objective response was defined as percentage of participants with a CR or PR that was confirmed by repeat assessments >/=4 weeks after initial documentation. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level; and reduction in all lymph nodes size to <10 mm. PR was defined as >/=30% decrease in the SoD of target lesions (taking as reference the baseline SoD).|Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years)|Analysis was performed on RE population (investigator) participants who did not receive prior chemotherapy.|||percentage of participants|||Number
2635660|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in Chemotherapy-Pretreated Participants|Tumor response was assessed by the investigator according to RECIST v1.1. Objective response was defined as percentage of participants with a CR or PR that was confirmed by repeat assessments >/=4 weeks after initial documentation. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level; and reduction in all lymph nodes size to <10 mm. PR was defined as >/=30% decrease in the SoD of target lesions (taking as reference the baseline SoD).|Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years)|Analysis was performed on RE population (investigator) participants who received prior chemotherapy.|||percentage of participants|||Number
2635661|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by Investigator in RE Population|Tumor response was assessed by the investigator according to RECIST v1.1. Objective response was defined as percentage of participants with a CR or PR that was confirmed by repeat assessments >/=4 weeks after initial documentation. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level; and reduction in all lymph nodes size to <10 mm. PR was defined as >/=30% decrease in the SoD of target lesions (taking as reference the baseline SoD). The 95% CI was computed using Clopper-Pearson method.|Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years)|Analysis was performed on RE population (Investigator) which included all participants with measurable disease at baseline according to the investigator, who had baseline tumor assessment and received at least one dose of alectinib.|||percentage of participants||95% Confidence Interval|Number
2635662|NCT01801111|Secondary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by IRC in Chemotherapy-Naive Participants|Tumor response was assessed by IRC according to RECIST v1.1. Objective response was defined as percentage of participants with a CR or PR that was confirmed by repeat assessments >/=4 weeks after initial documentation. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level; and reduction in all lymph nodes size to <10 mm. PR was defined as >/=30% decrease in the SoD of target lesions (taking as reference the baseline SoD).|Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years)|Analysis was performed on RE population (IRC) participants who did not receive prior chemotherapy.|||percentage of participants|||Number
2635663|NCT01801111|Primary|Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by IRC in Chemotherapy-Pretreated Participants|Tumor response was assessed by IRC according to RECIST v1.1. Objective response was defined as percentage of participants with a CR or PR that was confirmed by repeat assessments >/=4 weeks after initial documentation. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level; and reduction in all lymph nodes size to <10 mm. PR was defined as >/=30% decrease in the SoD of target lesions (taking as reference the baseline SoD). The 95% CI was computed using Clopper-Pearson method.|Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years)|Analysis was performed on RE population (IRC) participants who received prior chemotherapy.|||percentage of participants||95% Confidence Interval|Number
2635664|NCT01801111|Primary|Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR]) as Assessed by Independent Radiological Review Committee (IRC) in Response Evaluable (RE) Population|Tumor response was assessed by IRC according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Objective response was defined as percentage of participants with a CR or PR that was confirmed by repeat assessments >/=4 weeks after initial documentation. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level; and reduction in all lymph nodes size to less than (<) 10 millimeters (mm). PR was defined as >/=30 percent (%) decrease in the sum of diameters (SoD) of target lesions (taking as reference the baseline SoD). The 95% confidence interval (CI) was computed using Clopper-Pearson method.|Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years)|Analysis was performed on RE population (IRC) which included all participants with measurable disease at baseline according to the IRC, who had baseline tumor assessment and received at least one dose of alectinib.|||percentage of participants||95% Confidence Interval|Number
2635665|NCT01801111|Primary|Percentage of Participants With Dose Limiting Toxicities (DLTs)|DLTs were to be assessed based on the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.3 (NCI-CTCAE v 4.3). DLTs: drug-related toxicities that meet any one of the following criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding; Grade 4 neutropenia continuing for greater than or equal to (>/=) 7 consecutive days or neutropenic fever; Non-hematological toxicity of Grade 3 or higher; Adverse events that require interruption of treatment for a total of >/=7 days.|Cycle 1 (up to 28 days)|The endpoint was not analyzed in this study as the RP2D was confirmed in study NP28761 (NCT01871805).||||||
2635666|NCT01801111|Primary|Recommended Phase 2 Dose (RP2D) of Alectinib|RP2D was to be determined based on the safety and tolerability profile of the study treatment.|Cycle 1 (up to 28 days)|The endpoint was not analyzed in this study as the RP2D was confirmed in study NP28761 (NCT01871805).||||||
2635667|NCT01800968|Secondary|Global Ranking of Predefined Events|A rank score based on time to death, time to adjudicated heart failure hospitalization, time to emergency department visit and time-averaged proportional change in NTproBNP through d180. See Outcome Measure 1 for a general description of the outcome derivation.|Baseline to 180 days|All randomized subjects.|||rank||Standard Deviation|Mean
2635668|NCT01800968|Secondary|Individual Component of the Primary Endpoint- Time-averaged Proportional Change in NT-proBNP|Individual component of the primary endpoint- time-averaged proportional change in NT-proBNP from baseline to 180 days|Baseline to 180 days|All randomized subjects.|||weighted average of ratio to baseline||Standard Deviation|Mean
2635669|NCT01800968|Secondary|Individual Component of the Primary Endpoint- Heart Failure Hospitalization|Individual component of the primary endpoint- Heart Failure hospitalization from randomization to 180 days|Randomization to 180 days|All randomized subjects.|||participants|||Number
2635670|NCT01800968|Secondary|Individual Component of the Primary Endpoint- Mortality|Individual component of the primary endpoint of mortality at 180 days after randomization|Randomization to 180 days|All randomized subjects.|||participants|||Number
2635681|NCT01800968|Secondary|Change in Medial Filling Pressure|Change in medial filling pressure baseline to day 180.|Baseline to 180 days|All randomized subjects.|||m/sec||Standard Deviation|Mean
2635682|NCT01800968|Secondary|Change in Left Ventricular Ejection Fraction|Change in left ventricular ejection fraction from baseline to day 180|Baseline to 180 days|All randomized subjects.|||percent||Standard Deviation|Mean
2635683|NCT01800968|Secondary|Change in Left Ventricular End-systolic Volume Index|Change in left ventricular end-systolic volume index from baseline to day 180.|Baseline to 180 days|All randomized subjects.|||ml per meter squared||Standard Deviation|Mean
2635671|NCT01800968|Secondary|Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score.|Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 180 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 180 days|All randomized subjects.|||units on a scale||Standard Deviation|Mean
2635672|NCT01800968|Secondary|Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score|Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 90 days|All randomized subjects.|||units on a scale||Standard Deviation|Mean
2635673|NCT01800968|Secondary|Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score|Kansas City Cardiomyopathy Questionnaire (KCCQ) change in overall summary score baseline to 30 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 30 days|All randomized subjects.|||units on a scale||Standard Deviation|Mean
2635674|NCT01800968|Secondary|Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)|Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to day 180.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to day 180|All randomized subjects.|||units on a scale||Standard Deviation|Mean
2635675|NCT01800968|Secondary|Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)|Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 90 days.The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 90 days|All randomized subjects.|||units on a scale||Standard Deviation|Mean
2635676|NCT01800968|Secondary|Change in Clinical Summary Score Using the Kansas City Cardiomyopathy Questionnaire (KCCQ)|Change in clinical summary score using the Kansas City Cardiomyopathy Questionnaire (KCCQ) baseline to 30 days. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life.In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Each question is answered by the subject on a 6 point scale (Extremely limited, quite a bit limited, moderately limited, slightly limited, not at all limited, Limited for other reasons or did not do this activity).Scores are transformed to a range of 0-100, in which higher scores reflect better health status.|Baseline to 30 days|All randomized subjects.|||units on a scale||Standard Deviation|Mean
2635677|NCT01800968|Secondary|Change in 6 Minute Walk Distance|Change in 6 minute walk distance baseline to 180 days.|Baseline to 180 days|All randomized subjects.|||meters||Standard Deviation|Mean
2635678|NCT01800968|Secondary|Change in 6 Minute Walk Distance|Change in 6 minute walk distance baseline to 90 days.|Baseline to 90 days|All randomized subjects.|||meters||Standard Deviation|Mean
2635679|NCT01800968|Secondary|Change in 6 Minute Walk Distance|Change in 6 minute walk distance baseline to day 30|Baseline to day 30|All randomized subjects.|||meters||Standard Deviation|Mean
2635680|NCT01800968|Secondary|Change in Lateral Filling Pressure|Change in lateral filling pressure baseline to day 180.|Baseline to 180 days|All randomized subjects.|||m/sec||Standard Deviation|Mean
2635685|NCT01800968|Primary|Global Ranking of Predefined Events|A rank score based on time to death, time to adjudicated heart failure hospitalization, and time-averaged proportional change in NTproBNP through d180. For patients that died, the patient with the shortest time from randomization to death is assigned rank 1, the second shortest time is assigned rank 2, etc. The patient with the longest time from randomization to death is assigned rank X. For patients that did not die but had a heart failure hospitalization, the patient with the shortest time from randomization to re-admission is assigned rank X+1 and the patient with the longest time from randomization to heart failure hospitalization is assigned rank Y. For patients that did not die or have a heart failure hospitalization, increases in time-averaged proportional change in NTproBNP indicate a worse result and the largest increase is assigned rank Y+1. The patient with the largest decrease is assigned rank N, where N is the sample size.|Randomization to 180 days|All randomized subjects.|||rank||Standard Deviation|Mean
2635686|NCT01800916|Primary|Degree of Leakage|"The degree of leakage is measured using a 4-point leakage scale developed by Coloplast A/S at every baseplate change.~The subjects had to tick off one of the following choices:~No leakage~Starting to leak~Leakage~Sudden Leakage"|one week|The subjects were randomized to one of nine possible treatment groups. Each group consisted of three equal periods in which the subjects tested two test products and the comparator product (SenSura 1-piece). An equal distribution among the three arms and nine different treatment groups was aimed for. The ITT population was used for the analysis.|||percentage of baseplates with no leakage|baseplates||Number
2635687|NCT01800903|Primary|Overall Discomfort During Catheterization|Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.|1 day||||cm||Standard Deviation|Mean
2635688|NCT01800890|Primary|Degree of Leakage|"The degree of leakage is assessed using a 4 point leakage scale developed by Coloplast A/S.~The 4-point leakage scale has four choices~No leakage~Starting to leakage~Leakage~Sudden leakage~Leakage was assessed at every baseplate change"|10 days||||units on a scale|Participants|Standard Deviation|Mean
2635689|NCT01800877|Primary|MAP While on Vasopressors|The primary feasibility outcome will be the difference in the means of mean arterial pressures (MAP) while on vasopressors and we define acceptable adherence (the threshold for feasibility) by a difference of at least 5 mmHg while on vasopressors (rejecting the null hypothesis of a difference of less than 5 mmHg - see proposed sample size).|While on vasopressors from randomization until 28 days||||mmHg||Standard Deviation|Mean
2635690|NCT01800838|Primary|MTD of Silicon Phthalocyanine 4 Defined as the Dose Immediately Below the Dose in Which 2 or More of 6 Patients Experience a Grade 4 Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0||Up to 30 days||||mg/ml|||Number
2635691|NCT01800838|Primary|MTD of Photodynamic Therapy|Defined as the dose immediately below the dose in which 2 or more of 6 patients experience a grade 4 toxicity assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Up to 30 days||||J/cm^2|||Number
2635692|NCT01800786|Primary|Overnight Change in Declarative Memory Performance|"At 3 months, we compared average overnight changes between evening and morning performance on a declarative memory test between untreated OSA subjects and those who received CPAP therapy for 3 months.~Positive numbers represent an increase in performance."|3 months||||percent change in performance||Standard Deviation|Mean
2635693|NCT01800318|Secondary|Duration of Crying During Heel Stick|Any crying during the heel stick procedure was timed in seconds.|5 minutes +/- 2 minutes|Newborn infants during heel stick procedure, crying timed in seconds|||seconds||Standard Deviation|Mean
2635694|NCT01800318|Secondary|Duration of Crying After TENS Unit Was Initiated But Before Heel Stick.|(a) Any crying after initiation of TENS unit was noted. If the PIPP scores increased by 4 points from baseline, the TENS unit would have been turned off and the infant withdrawn from the study (safety outcome).|10 minutes||||seconds||Standard Deviation|Mean
2635695|NCT01800318|Secondary|Change in Heart Rate Variability During Heel Stick|Changes in Heart Rate Variability (HRV) were evaluated using the DL 900 monitor with 3-channel output with 5 leads. Premature infant leads from Braemar, Incorporated, were used with the DL 900 monitor. Leads were applied to the infant's chest before initiation of the TENS unit and the heel stick. The DL300 Holter Monitor will started recording HRV within 10 minutes of TENS unit initiation and the heel stick procedure and continued recording during the procedure and for 2 minutes afterwards.|Baseline, 20 minutes +/- 5 minutes|Newborn infants|||LF/HF ratio||Standard Deviation|Mean
2635696|NCT01800318|Secondary|Change in Salivary Cortisol After Heel Stick|Salivary cortisol was obtained prior to initiation of heelstick procedure, and at 5±0.5 minutes after procedure by gentle insertion in the mouth of a soft applicator (Salimetrics Infant Swab). The samples were stored at -20 degrees, and were analyzed at UAMS.|Baseline and 5±0.5 minutes after heel stick||||ng/ml||Standard Deviation|Mean
2635697|NCT01800318|Primary|Changes From Baseline Premature Infant Pain Profile (PIPP) Score to Average PIPP Score During Heel Stick and Squeeze.|"The PIPP score includes assessment of contextual, physiological, and behavioral parameters and has been extensively validated for pain assessment in preterm and term infants. PIPP scores were given at baseline before initiation of the TENS unit,and every 30 seconds for the first two minutes of the heel stick and heel squeeze (4 times). The four PIPP scores given during heel stick and squeeze were averaged.~Behavioral portion of PIPP score: facial expressions are videotaped and analyzed. Physiologic portion of PIPP score: Oxygen saturation levels and heart rates are recorded at baseline and then continuously throughout initiation of the TENS unit and the heel stick procedure. Contextual score - gestational age + sleep/wake state. Subscale scores are added for a total PIPP score. Total or composite PIPP scores are reported.~Scores on the PIPP for full term infants range from 0-18, with 0 being no pain, 1-6 minimal pain, 7-12 moderate pain, 13-18 severe pain."|Baseline and first two minutes of heel stick an squeeze. PIPP scores are given every 30 seconds for the first two minutes of the heel stick and squeeze and then averaged..|Analysis of PIPP scores assigned during heelstick procedure in newborn infants|||units on a scale (PIPP score)||Standard Deviation|Mean
2635698|NCT01800201|Secondary|Proportion of Days Covered (PDC) for a Subset of Patients for Whom we Have Prescription Information|"Calculated by the proportion of days in which a patient has an active medication for all three medications (statin, beta blocker and antiplatelet). It is not the weighted average of the individual medication. This reflects the intermediate definition of adherence: our intermediate definition assumed that patients had been prescribed a medication for the entire study period if they ever filled that medication after discharge"|12 months||||PDC, mean||Standard Deviation|Mean
2635713|NCT01799993|Other Pre-specified|Number of Participants With Organ Failure|The overall number of participants with any organ failure was summarized for each treatment group. Organ failure was defined by a specific organ type and by a collection of MedDRA version 20.0 preferred terms that were determined by the sponsor's clinical team. A participant with multiple AEs within a system organ class or preferred term is counted a single time for that system organ class (SOC) or preferred term.|Up to 7 days after the end of study treatment|ITT for Safety population|||Participants|||Count of Participants
2635714|NCT01799993|Other Pre-specified|Number of Participants Who Received at Least One Dose of Study Drug and Reported a Serious Adverse Event|AE was untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Serious AE: AE resulting in following outcomes or deemed significant for any reason: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent; significant disability/incapacity; congenital anomaly/birth defect; medical important serious event judged by investigator. SAEs, occurred any time after the first dose of therapy and through 7 days after the EOT were recorded as treat-emergent SAEs (TESAEs).|Up to 7 days after the end of study treatment|ITT for Safety population|||Participants|||Count of Participants
2635715|NCT01799993|Other Pre-specified|Number of Participants Who Received at Least One Dose of Study Drug and Reported an Adverse Event|AE was untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs, occurred any time after the first dose of therapy and through 7 days after the EOT were recorded as treat-emergent AEs (TEAEs).|Up to 7 days after the end of study treatment|ITT for Safety population (included all participants in ITT analysis set who were analyzed as treated for safety analyses)|||Participants|||Count of Participants
2635716|NCT01799993|Other Pre-specified|Number of Participants With Emergence of Resistance Among Pathogens|Resistance to amikacin was determined for the bacterial isolates by using a standardized microbiology laboratory test that generates a minimum inhibitory concentration (MIC) for amikacin and bacterial isolate. The same microbiology resistance standard was used for all bacteria tested against amikacin. Resistant bacteria have a MIC value of 64 μg/mL or greater. Percentages of resistance were calculated based on the percentage of participants infected with any treatment-emergent pathogens resistant to amikacin. If a participant had a more than one occurrence of a specific pathogen during pre-treatment period, the worst case of testing was used.|Up to 28-32 days after start of study treatment|mITT population participants with pathogen susceptible to amikacin in pre-treatment period|||Participants|||Count of Participants
2635717|NCT01799993|Other Pre-specified|Number of Participants With Emergence of New Respiratory Pathogens During the Aerosol Treatment Period|New pathogens also denoted as superinfection was defined as the isolation of a new pathogen (not the original baseline pathogen) from a specimen taken while the participant was on antibiotic therapy (Day 1 to EOT) and having a need for alternative antimicrobial therapy. Rates of emergence of any new pathogen by participant after start of study drug were summarized for each treatment group.|Up to 10 days after start of study treatment|mITT population|||Participants|||Count of Participants
2635718|NCT01799993|Other Pre-specified|Number of Participants With Microbiological Recurrence at LFU Visit|"The responses of recurrence were tabulated for each participant. Recurrence was defined as the reappearance of the original pathogen(s) from a specimen taken after the TOC visit. If one or more pathogen reappeared, all isolates from a participant were tabulated as recurrence. Baseline pathogen was defined as pathogens tested at Screening and Day 1 visit by central laboratory."|Up to 28-32 days after start of study treatment|mITT population|||Participants|||Count of Participants
2635719|NCT01799993|Other Pre-specified|Number of Participants With Microbiological Response at TOC Visit|The responses of eradication (defined as the absence of the original pathogen(s) at the post-treatment TOC culture of specimens from the original site of infection) and presumed eradication (defined as absence of appropriate culture material in a participant judged to be a clinical cure; he or she was unable to produce sputum and invasive procedures were not warranted) were tabulated for each participant to reveal the microbiological responses. All pathogen isolates from a participant must be eradicated (or presumed eradicated) to tabulate an eradicated (or presumed eradicated) response. Baseline pathogen was defined as pathogens tested at Screening and Day 1 visit by central laboratory.|Up to 17-19 days after start of study treatment|mITT population|||Participants|||Count of Participants
2635720|NCT01799993|Other Pre-specified|Number of Participants With Microbiological Response Per Pathogen at TOC Visit|The number of participants with microbiological response for each pathogen among the total number of participants with baseline pathogen isolates for each pathogen was determined. If a participant had 3 pathogens, all 3 were tabulated. Eradication ( defined as the absence of the original pathogen(s) at the post-treatment test-of-cure [TOC] visit culture of specimens from the original site of infection) and presumed eradication (defined as absence of appropriate culture material in a participant judged to be a clinical cure; he or she was unable to produce sputum and invasive procedures were not warranted) rates were reported to reveal the microbiological responses. The data were displayed for each bacterial genus/species. Baseline pathogen was defined as pathogens tested at Screening and Day 1 visit by central laboratory.|Up to 17-19 days after start of study treatment|mITT population|||Participants|||Count of Participants
2635721|NCT01799993|Secondary|Number of Days in the ICU Through LFU Visit|Number of days in ICU was summarized by descriptive statistics. Duration was defined as the number of days from the date of first study drug through the LFU visit. For participants who lived in ICU through the LFU visit, the ICU days were actual days in ICU with a maximum value of 28 days. For participants who died after Day 28 but on or before their LFU visit, the days in ICU was censored at 28 days. For participants who died or discontinued in ICU, the number of days in ICU was 28 days. Further analysis of the number of days in ICU was to be performed with censoring at Day 28 for subset of participants on ventilation and without censoring.|Up to 28-32 days after start of study treatment|mITT population without missing start or end dates|||day||Standard Deviation|Mean
2635738|NCT01799720|Secondary|Glutamic Pyruvic Transaminase (GPT) (U/L) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the Glutamic Pyruvic Transaminase (GPT) of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||Units / litre||Standard Error|Mean
2635739|NCT01799720|Secondary|Triglycerides (TGs) (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the Triglycerides (TGs) of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||milligram / decilitre||Standard Error|Mean
2635722|NCT01799993|Secondary|Number of Days on Mechanical Ventilation Through LFU Visit|Number of days on mechanical ventilator was summarized by descriptive statistics. Duration was defined as the number of days from the date of first study drug through the LFU visit. For participants who lived through the LFU visit, the ventilation days were actual days on ventilation with a maximum value of 28 days. For participants who died after Day 28 but on or before their LFU visit, the days on ventilator was censored at 28 days. For participants who died or discontinued off ventilation, the number of days on ventilation was actual days on ventilation with a maximum value of 28 days. For participants who died or discontinued on ventilation, the number of days on ventilation was 28 days. Further analysis of the number of days on mechanical ventilator was to be performed with censoring at Day 28 for subset of participants on ventilation without censoring.|Up to 28-32 days after start of study treatment|mITT population|||day||Standard Deviation|Mean
2635723|NCT01799993|Secondary|Number of Participants With Early Clinical Response|Early Clinical Response was determined by the following: 1. CPIS scoring at Days 3, 5, and 10 compared to baseline (a. On Day 3, CPIS increase from baseline by at least 2 points was considered a failure. b. On Day 5, CPIS decrease from baseline of at least 1 point was not a failure. CPIS of no change from baseline was considered a failure. Any CPIS increase from baseline was a failure. c. On Day 10, CPIS decrease from baseline of at least 2 points was not a failure. CPIS decrease of only 1 point is a failure. Clinical Pulmonary Infection Score of no change was considered a failure. Any CPIS increase from baseline was a failure). 2. All-cause mortality through EOT visit was a failure. 3. The development of empyema or lung abscess through the EOT visit was a failure.|Up to 10 days after start of study treatment|mITT population|||Participants|||Count of Participants
2635724|NCT01799993|Secondary|Number of Participants With Adjudicated Pneumonia-Related Death Through LFU Visit|Death through LFU visit was adjudicated as pneumonia-related or pneumonia-unrelated for participants in the amikacin inhale group and participants in the placebo group.|Up to 28-32 days after start of study treatment|Participants who died through LFU visit in mITT population set|||Participants|||Count of Participants
2635725|NCT01799993|Primary|Number of Participants Surviving Through LFU Visit|The primary efficacy variable is Survival through the late follow-up (LFU) visit. Survival is achieved when the participant is alive through the LFU visit. No other factors are considered in the evaluation of survival.|Up to 28-32 days after start of study treatment|Modified intent-to-treat (mITT) population (included all subjects who had a culture-confirmed Gram-negative bacteria that had been treated with at least one dose of study treatment, and had an APACHE II score ≥ 10 at the time of diagnosis of pneumonia)|||Participants|||Count of Participants
2635726|NCT01799941|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs (defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) and SAEs (defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening [ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death], required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug) were assessed during the study.|From signing of informed consent up to 30 days after receiving the last dose of study drug or up to approximately 120 days|The analysis was performed using the safety population that consisted of all enrolled patients who received at least 1 dose of study drug.|||Participants|||Number
2635727|NCT01799941|Secondary|Percentage of Participants With Treatment Satisfaction Survey|The treatment satisfaction survey was a 5 point single question survey that was administered by the site staff to the participant/participant's caregiver. Participants were asked to rate their response to treatment satisfaction as: very dissatisfied, somewhat dissatisfied, neither satisfied nor dissatisfied, somewhat satisfied, and very satisfied. Data is presented as percentage of participants with treatment satisfaction at Day 90. Percentages within a measure may not sum to 100.0 due to rounding. Percentages use the count of participants with non-missing data as the denominator.|Day 90 (Final visit)|The mITT Population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with CNS-LS.|||Percentage of participants|||Number
2635728|NCT01799941|Secondary|Percentage of Participants With Patient Global Impression-Change (PGI-C) Score at Day 90|PGI-C, a participant/participant's caregiver-assessed scale was used to measure participant overall treatment response. PGI-C, a 7-point (1-7) scale was rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. Data is presented as percentage of participants with PGI-C score at Day 90. Percentages within a measure may not sum to 100.0 due to rounding. Percentages use the count of participants with non-missing data as the denominator.|Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PGI-C.|||Percentage of participants|||Number
2635729|NCT01799941|Secondary|Percentage of Participants With Clinical Global Impression-Change (CGI-C) Score at Day 90|CGI-C, an investigator-assessed scale was used to measure the overall treatment response. CGI-C, a 7-point (1-7) scale was rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. Data is presented as percentage of participants with CGI-C score at Day 90. Percentages within a measure may not sum to 100.0 due to rounding. Percentages use the count of participants with non-missing data as the denominator.|Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with CGI-C.|||Percentage of participants|||Number
2635740|NCT01799720|Secondary|Cholesterol (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the cholesterol of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||milligram / decilitre||Standard Error|Mean
2635741|NCT01799720|Secondary|Glucose (mg/dL) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the glucose of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||milligram / decilitre||Standard Error|Mean
2635730|NCT01799941|Secondary|Mean Change From Baseline in Quality of Life Visual Analog Scale (QOL-VAS) Score at Day 90|"The QOL-VAS, a participant reported scale of quality of life (QOL) was used to measure the impact of PBA episodes on the participant's QOL over the previous 7 days (prior to visit) at Baseline (Day 1) and Day 90 (Final visit). The assessment was completed by a participant placing a mark on a horizontal line that extends from 0 not (affected) at all to 10 significantly (affected). The participant's mark was measured and recorded at each time point. The change in QOL-VAS score from baseline to day 90 visit, defined as the day 90 score minus the baseline score, was analyzed. Data is reported as mean QOL-VAS score; a positive change in score represented an increase in participant's quality of life."|Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with QOL-VAS.|||Units on a scale||Standard Deviation|Mean
2635731|NCT01799941|Secondary|Percentage of Participants With ≥ 75% Reduction in PBA Episode Count Per Week|Data is reported as the percentage of participants with ≥ 75% reduction in PBA episode count/week.|Day 30 (Visit 1) and Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.|||Percentage of participants|||Number
2635732|NCT01799941|Secondary|Percentage of Participants With ≥ 50% Reduction in PBA Episode Count Per Week|Data is reported as the percentage of participants with ≥ 50% reduction in PBA episode count/week.|Day 30 (Visit 1) and Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.|||Percentage of participants|||Number
2635733|NCT01799941|Secondary|Percentage Change From Baseline in PBA Episode Count Per Week|The change from the baseline PBA rate was measured using Mixed Effects Poisson Regression Model (adjusted for gender and age [≤ 65 years]).|Day 30 (Visit 1) and Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.|||percent change||95% Confidence Interval|Mean
2635734|NCT01799941|Secondary|Percentage of Participants With PBA Remission|PBA remission was defined as participants with one or more episodes reported at the baseline (Day 1) visit and zero episodes reported at the Day 30 (Visit 1) or Day 90 (Final visit). Data is reported as percentage of participants with no reported episodes over the previous 7 days (prior to visit) at Day 30 (Visit 1) and Day 90 (Final visit).|Day 30 (Visit 1) and Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.|||Percentage of participants|||Number
2635735|NCT01799941|Secondary|Mean Pseudobulbar Affect (PBA) Episode Count Per Week by Visit|PBA episode count was an investigator assessed measure in which the participant/participant's daytime caregiver was asked to identify, count and recall the total episodes of exaggerated/uncontrollable laughing or crying over the previous 7 days (prior to visit) at Baseline (Day 1), Day 30 (Visit 1), and Day 90 (Final visit). The response categories for this question were: 0, 1- 2, 3-5, 6-10, >10. The original responses from participants were converted to estimate the continuous number of PBA episodes by taking the mid-point of the original response ranges and multiplying that value by 7. Data is presented as mean PBA count per week.|Baseline (Day 1), Day 30 (Visit 1), and Day 90 (Final visit)|The analysis population consisted of all participants who met all inclusion criteria, including a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with PBA episode.|||Count/week||Standard Deviation|Mean
2635736|NCT01799941|Secondary|Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 30|The CNS-LS was a seven-item, self-administered questionnaire, completed by the participant or participant's caregiver that provided a quantitative measure of the perceived frequency and severity of Pseudobulbar Affect (PBA) episodes. It consisted of two subscales measuring labile laughter (four items) and labile crying (three items). Each item was rated on a scale from 1 (applies never) to 5 (applies most of the time). The total score was calculated as the sum of the item values that resulted in a score ranging from 7 (no symptoms) to 35 (maximum symptom severity and frequency). A single continuous variable was created for the reported time point. The change in CNS-LS was calculated as the score from the Day 30 assessment minus the Baseline CNS-LS measure. A negative change represented a decrease in CNS-LS score over time following the baseline assessment indicating a perceived decrease in frequency and severity of PBA episodes.|Day 30|The analysis was performed using the mITT population, defined as all participants who met all inclusion criteria, with a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with CNS-LS.|||Units on a scale||Standard Deviation|Mean
2635737|NCT01799941|Primary|Mean Change From Baseline in Center for Neurologic Study-Lability Scale (CNS-LS) Score at Day 90|The CNS-LS was a seven-item, self-administered questionnaire, completed by the participant or participant's caregiver that provided a quantitative measure of the perceived frequency and severity of Pseudobulbar Affect (PBA) episodes. It consisted of two subscales measuring labile laughter (four items) and labile crying (three items). Each item was rated on a scale from 1 (applies never) to 5 (applies most of the time). The total score was calculated as the sum of the item values that resulted in a score ranging from 7 (no symptoms) to 35 (maximum symptom severity and frequency). A single continuous variable was created for the reported time point. The change in CNS-LS was calculated as the score from the Day 90 assessment minus the Baseline CNS-LS measure. A negative change represented a decrease in CNS-LS score over time following the baseline assessment indicating a perceived decrease in frequency and severity of PBA episodes.|Day 90 (Final visit)|The analysis was performed using the Modified Intent-to-treat (mITT) Population, defined as all participants who met all inclusion criteria, with a score of at least 13 on the CNS-LS, who received at least 1 dose of study drug, and who had at least 1 post-baseline efficacy measurement with CNS-LS.|||Units on a scale||Standard Deviation|Mean
2635744|NCT01799720|Secondary|Hip/Waist Ratio of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)|In this table the investigators present the hip/waist ratio of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||ratio*100||Standard Error|Mean
2635745|NCT01799720|Secondary|Body Mass Index (BMI) (Kg/m2) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the Body Mass Index of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||kilogram / square metre||Standard Error|Mean
2635746|NCT01799720|Secondary|Height (Metre) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30).|In this table the investigators present the height of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||metres||Standard Error|Mean
2635747|NCT01799720|Primary|Weight (Kilogram) of Volunteers at the Beginning (Day 1) and at the End of the Study (Day 30)|In this table the investigators present the weight (kilogram) of the three intervented groups. Data are mean ± sem.|Days 1 and 30||||kilogram||Standard Error|Mean
2635748|NCT01799590|Secondary|Quality of Life (QOL) Questionnaire (Short Form-36 [SF-36]) Score|The SF-36 is a standardized survey evaluating 8 domains (consisting of 2 components; physical and mental) of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Final evaluation (FE) was done at Day 225 or at discontinuation.|Baseline (28 days before randomization) and FE (Day 225/early discontinuation)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization. Here ‘n’ signifies those participants who were evaluable for this measure at given time points.|||Units on a scale||Standard Deviation|Mean
2635749|NCT01799590|Secondary|Percentage of Participants With Response to Treatment|Responders were defined as participants who had a 50 percent or more reduction in frequency of migraine attacks. Migraine is common disabling headache disorder with 2 subtypes: migraine without aura (at least 5 attacks lasting 4-72 hours with at least 2 characteristics: unilateral location, pulsating quality, moderate/severe pain or aggravation by/causing avoidance of routine physical activity and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (attack with reversible focal neurological symptoms that develop over 5-20 minutes and last for less than 60 minutes).|Baseline (28 days before randomization) up to Day 225|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Percentage of participants|||Number
2635750|NCT01799590|Secondary|Change From Baseline in the Average Number of Monthly Rescue-Drug Treatment Days in Continuous Treatment Period|If aura of migraine, migraine attack or non-migraine headache attack occurred in study, these rescue drugs were permitted:analgesics, non-steroidal anti-inflammatory drugs (NSAIDs),ergotamines,triptans,antiemetics. Drugs with restricted treatment days of less than (<) 15 days per month (28 days):analgesics, NSAIDs,combination of rescue drugs and those with <10 days per month:triptans,ergotamines, opioids,combination analgesics. Average calculated as total number of monthly rescue-drug treatment days divided by the total number of days of assessment and multiplied by 28, where a month = 28 days.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Days||Standard Deviation|Mean
2635751|NCT01799590|Secondary|Change From Baseline in the Number of Migraine Attacks as Per 24-hour Rule Over Day 197 to Day 225 in Continuous Treatment Period|As per 24-hour rule, if symptom of pain because of migraine continues for more than 24 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 24 hours. If interval between the latest migraine attack (ending time) and previous migraine attack (onset time) is less than 24 hours, 2 migraine attacks were considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug it was considered as 1 migraine attack even if the aura had started.|Baseline (28 days before randomization) and Day 197 to Day 225|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Migraine attacks||Standard Deviation|Mean
2635752|NCT01799590|Secondary|Change From Baseline in the Number of Monthly Migraine Attacks as Per 48-hour Rule in Continuous Treatment Period|As per 48-hour rule, if the symptom of pain because of migraine continues for more than 48 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 48 hours. If the interval between the latest migraine attack (ending time) and the previous migraine attack (onset time) is less than 48 hours, 2 migraine attacks were considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug it was considered as 1 migraine attack even if the aura had started.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Migraine attacks||Standard Deviation|Mean
2635753|NCT01799590|Secondary|Change From Baseline in the Average Number of Migraine Attacks According to the Diagnostic Criteria of the International Headache Society Per Month in Continuous Treatment Period|Migraine has 2 major subtypes: migraine without aura (minimum 5 attacks of headache lasting for 4-72 hours, has 2 of these characteristics [unilateral location, pulsating quality, moderate or severe pain intensity, aggravation by or causing avoidance of routine physical activity] and either nausea/vomiting or photophobia and phonophobia) and migraine with aura (2 attacks of headache with typical aura with migraine headache or typical aura with non-migraine headache or typical aura without headache or familial hemiplegic migraine or sporadic hemiplegic migraine or basilar-type migraine).|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Migraine attacks||Standard Deviation|Mean
2635778|NCT01798992|Other Pre-specified|Change in Myocardial Gene Expression at 3 Months|Changes in myocardial mRNA expression at 3 months compared to baseline using targeted quantitative polymerase chain reaction and genome wide microarray assays. Due to the large number of results genes interrogated (~ 20,000 genes), these results will instead be uploaded to the Gene Expression Omnibus.|3 months|||||||
2635754|NCT01799590|Secondary|Change From Baseline in the Average Number of Monthly Headache Days in Continuous Treatment Period|Migraine headache day was defined as a calendar day with any occurrence of migraine headache pain of at least 30 minutes in duration. Average was calculated as total number of monthly headache days divided by total number of days of assessment and multiplied by 28, where a month was considered to last 28 days.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Days||Standard Deviation|Mean
2635755|NCT01799590|Secondary|Change From Baseline in the Average Number of Monthly Migraine Attack Days in Continuous Treatment Period|Migraine:disabling headache disorder;2 major subtypes:migraine without aura(at least 5 attacks for 4-72 hours with at least 2 characteristics: unilateral location,pulsating quality,moderate/severe pain intensity or aggravation by/causing avoidance of routine physical activity and either nausea/vomiting or photophobia,phonophobia);migraine with aura(attack with reversible focal neurological symptoms that develop over 5-20 minutes, last for less than 60 minutes);average=total number of migraine attack days divided by total number of days of assessment and multiplied by 28,where a month=28 days.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|The FAS included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Days||Standard Deviation|Mean
2635756|NCT01799590|Secondary|Change From Baseline in the Number of Monthly Migraine Attacks as Per 24-hour Rule in the Continuous Treatment Period|As per 24-hour rule, if symptom of pain because of migraine continues for more than 24 hours, it should be considered as 2 or more migraine attacks considering the maximum duration up to 24 hours. If interval between the latest migraine attack (ending time) and previous migraine attack (onset time) was less than 24 hours, 2 migraine attacks were considered as 1 migraine attack. If the onset of the migraine was prevented by a rescue drug it was considered as 1 migraine attack even if the aura had started.|Baseline (28 days before randomization) and Continuous treatment period (Day 1 up to Day 225)|Full analysis set (FAS) included all participants randomly assigned to study treatment excluding those who did not meet eligibility criteria, did not receive study treatment at all and did not provide any efficacy data after randomization.|||Migraine attacks||Standard Deviation|Mean
2635757|NCT01799590|Primary|Number of Participants With Adverse Events|An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.|Baseline up to 28 days after last dose of study drug|Safety population included all participants who received at least 1 dose of study medication.|||Participants|||Number
2635758|NCT01799278|Secondary|Circulating Tumor Cell (CTC) Response|CTC counts by CellSearch will be performed at baseline, at 4-6 weeks, and upon progression to determine response.|2 years|Data were not collected for this outcome.||||||
2635759|NCT01799278|Secondary|Prostate-Specific Antigen (PSA) Test Response Rate|PSA to be followed every cycle to determine response.|2 years|Data were not collected for this outcome.||||||
2635760|NCT01799278|Secondary|Overall Survival in Response to Therapy|Patients will be followed for survival endpoints following completion of this study until death|3 years||||months||95% Confidence Interval|Median
2635761|NCT01799278|Secondary|Progression-free Survival in Response to Therapy|Patients will be followed for survival endpoints following completion of this study until death.|3 years||||months||95% Confidence Interval|Median
2635762|NCT01799278|Primary|Response Rate, as Assessed by CT/MRI and Bone Scan, of Treatment With MLN8237 for Patients With Neuroendocrine Prostate Cancer|Evaluated per RECIST 1.1 guidelines: Complete response (CR) is defined as complete disappearance of all measurable and evaluable lesions by physical examination or imaging studies and normalization of PSA with no appearance of new lesions for > 1 month. Partial response (PR) is defined as a 30% 56 or greater reduction in the sum longest unidimensional diameter of all measurable lesions. There may be no new lesions. Stable Disease (SD) is characterized by patients who do not meet the criteria of PR and who are without signs of progressive disease for at least 1 month. Disease Progression (DP) is defined as a greater than 20% increase in the sum longest unidimensional diameters of the indicator lesions or the appearance of new lesions. Bone scan progression (evaluable disease only) is defined by PCWG2 criteria. Per consensus guidelines in CRPC, to be considered measurable, lymph nodes need to be at least 2 cm in greatest dimension and 1.5 cm in short axis.|one year||||participants|||Number
2635763|NCT01799239|Primary|Leakage (Percentage of All Baseplates With Leakage)|"leakage is measured using a 4-point leakage scale developed by Coloplast A/S. At every baseplate change the subjects had to look at the skin facing side of the baseplate and access which of the four scenarios described below provided an accurate description of the baseplate.~The subjects tick of one of the four possible answers:~No leakage~Starting to leak (leakage under the baseplate)~Leakage (seepage of faeces resulting in leakage on clothes)~Sudden leakage (the baseplate pops off resulting in sudden leakage under the baseplate and outside the baseplate)"|After each baseplate change over a period, of 7 days||||percentage baseplates with leakage|Participants||Number
2635764|NCT01799226|Other Pre-specified|Gingival Crevicular Fluid (GCF) Will be Collected for Inflammatory Biomarker Expression.|A total of 10 biomarkers will be analyzed based on the results from Lee and colleagues: IL-1α, IL-1β, IL-6, IL-8, IL-10, MCP-1, MMP-8, MMP-9, TIMP-1, and TIMP-2.|Baseline to 35 Days|||||||
2635765|NCT01799226|Other Pre-specified|Plaque Samples Will be Collected for Bacterial Species Detection.|Supra- and sub-gingival plaque samples will be gently collected using a sterile curet and a one stroke method from two randomized sites within the stent area. The detection of 40 bacterial species will be evaluated by the checkerboard DNA-DNA hybridization technique originally described by Socransky et al. 1994.|Baseline to 35 Days|||||||
2635766|NCT01799226|Other Pre-specified|Unstimulated Whole Saliva Will be Collected for Inflammatory Biomarker Expression.|Inflammatory biomarker expression will be quantified using a custom human 10-complex protein array that is optimized for sensitivity, specificity, stability, and intraassay coefficient of variation by comparing to single cytokine enzyme-linked immunosorbent assays (Quantibody Custom Array, RayBiotech, Norcross, GA).|Baseline to 35 Days|||||||
2671475|NCT01475955|Secondary|Complete Clearance Rate|The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 4|ITT LOCF|||participants|||Number
2635767|NCT01799226|Primary|Change From Baseline in Plaque Index (Silness & Loe 1964) to Day 35|Silness & Loe 1964 is a score of 0-3 with 0 = No plaque, 1 = A film of plaque adhering to free gingival margin and adjacent area of tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface, 2 = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye, 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin. This index was used at days 0, 14, 21 and 35.|Baseline to 35 Days|Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).|||units on a scale||Standard Error|Mean
2635768|NCT01799226|Secondary|Change From Baseline in Gingival Index (Loe & Silness 1963) to Day 35|Loe & Silness 1963 is a score of 0-3 with 0 = Absence of inflammation, 1 = Mild inflammation, slight change in color and texture, 2 = Moderate inflammation, glazing, redness, edema and hypertrophy, 3 = Severe inflammation, redness and hypertrophy, ulceration. This index was used at days 0, 14, 21 and 35.|Baseline to 35 Days|Data analysis only included examining the test (triclosan dentifrice) or control (fluoride dentifrice).|||units on a scale||Standard Error|Mean
2635769|NCT01799213|Secondary|Adherence to Study Medication (Assessed in % of Weeks With Perfect Adherence)|"Over the past week, how many days did you use the study drug for your knee pain?~Over the past week, how many days did you use Tylenol or acetaminophen for your knee pain?~Over the past week, how many days did you use other medications that were prescribed by one of your doctors for your knee pain?~Over the past week, how many days did you use other medications, creams or supplements that you got without a prescription for your knee pain?~Over the past week, how many days did you use any medications for a different problem or type of pain (e.g. headache)? Results reported as percentage of study weeks with perfect participant adherence to study medications, with higher percentages indicating higher adherence."|Weekly, for duration of observation period (14 weeks)|All eligible subjects with any adherence data reported.|||% weeks with perfect adherences|||Number
2635770|NCT01799213|Secondary|Adherence to Study Medication (Assessed in Weeks Adherent)|"Over the past week, how many days did you use the study drug for your knee pain?~Over the past week, how many days did you use Tylenol or acetaminophen for your knee pain?~Over the past week, how many days did you use other medications that were prescribed by one of your doctors for your knee pain?~Over the past week, how many days did you use other medications, creams or supplements that you got without a prescription for your knee pain?~Over the past week, how many days did you use any medications for a different problem or type of pain (e.g. headache)? Results reported as percentage of study weeks with perfect participant adherence to study medications, with higher percentages indicating higher adherence."|Weekly, for duration of observation period (14 weeks)|All eligible subjects with any adherence data reported.|||Weeks Adherent||Inter-Quartile Range|Median
2635771|NCT01799213|Secondary|Global Impression of Change|A balanced 5-point scale (rated 1 = Much better to 5 = Much worse) asking subjects to rate their change (if any) in pain since starting the study. The possible range of scores is 1 to 5.|14 weeks|Global impression of change was available in 336 (92%) participants at the end of Phase 2|||score on a scale||Standard Error|Mean
2635772|NCT01799213|Secondary|Lower Extremity Disability|Lower extremity disability: Lower extremity functional outcomes will be measured using the WOMAC disability scale. The physical disability scale contains 17 items that assess the amount of difficulty subjects say they have with climbing stairs, rising from a chair, walking, and other activities of daily living. Responses are measured and scored in the same way as the pain scale. The WOMAC lower extremity disability score has a possible score range of 0-68 and higher scores indicate worse functional limitation.|14 weeks|WOMAC lower extremity disability scores were available in 336 (92%) participants at the end of Phase 2.|||score on a scale||Standard Error|Least Squares Mean
2635773|NCT01799213|Secondary|Area Under the Curve (AUC) of the WOMAC Pain Scale Score Over 14 Weeks|The AUC is a commonly used measure that combines multiple measurements over a specific time interval into a single index. The AUC provides a single score that quantifies each participant's total WOMAC score across the repeated measurements. The AUC is valid regardless of increases or decreases in reported pain over time. In this case, the possible range is 0-20, with higher scores indicating worse pain.|14 Weeks|Those with no post-randomization pain measurements (n= 5 in meloxicam group, n= 4 in placebo) were excluded from all analyses of pain, leaving 355 (98%) participants for this analysis.|||units on a scale*week||Standard Error|Mean
2635774|NCT01799213|Primary|Primary Endpoint: WOMAC Pain Score (Likert Scale Version) at 4 Weeks|The WOMAC pain score has a possible score range of 0-20 for Pain and higher scores indicate worse pain. The WOMAC pain scale consists of 5 questions that ask about pain during walking, stair use, lying in bed at night, sitting, and standing. Each question is scored on a 5-point scale, where 0 = None, 1 = Mild pain, 2 = Moderate pain, 3 = Severe pain, and 4 = Very severe pain. Total pain scores range from 0 to 20 with higher scores reflecting worse pain. The WOMAC also includes a lower extremity disability scale. Both the pain scale and disability scale (17 items) can be analyzed separately.|4 Weeks|The WOMAC pain score was available for 84% (152/180) of participants in the placebo group and 92% (169/184) of participants in the meloxicam group four weeks post-randomization.|||units on a scale||Standard Error|Mean
2635775|NCT01798992|Other Pre-specified|Change in Myocardial microRNA Expression at 12 Months|Changes in myocardial microRNA expression at 12 months compared to baseline using an Affymetrix microRNA microarray assay. Data are not presented for non-failing controls, who only went baseline evaluation and did not undergo treatment, given that they did not have heart failure.|12 months|||||||
2635776|NCT01798992|Other Pre-specified|Change in Myocardial microRNA Expression at 3 Months|Changes in myocardial microRNA expression at 3 months compared to baseline using an Affymetrix microRNA microarray assay. Data are not presented for non-failing controls, who only went baseline evaluation and did not undergo treatment, given that they did not have heart failure.|3 months|||||||
2635777|NCT01798992|Other Pre-specified|Change in Myocardial Gene Expression at 12 Months|Changes in myocardial mRNA expression at 12 months compared to baseline using targeted quantitative polymerase chain reaction and Affymetrix genome-wide microarray assays. Data are not presented for non-failing controls, who only went baseline evaluation and did not undergo treatment, given that they did not have heart failure.|12 months|||||||
2635874|NCT01798186|Secondary|Delta-9-tetrahydrocannabinol (THC) Cmax in Oral Fluid|After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in oral fluid.|Samples collected 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposure||||ng/mL||Full Range|Mean
2635779|NCT01798992|Secondary|Composite of All-cause Mortality, Need for Heart Transplant or Need for Ventricular Assist Device.|Clinical status at 18 months will be assessed at time of study completion, specifically for the composite outcome of all-cause mortality, need for heart transplant, or need for ventricular assist device. Outcomes are not presented for non-failing controls, who only went baseline evaluation and did not undergo treatment, given that they did not have heart failure.|18 months|Idiopathic dilated cardiomyopathy patients randomized to different beta-blocker strategies. Data does not include non-failing controls, as these patients only underwent baseline evaluation with no treatment or follow-up, given that they did not have heart failure.|||participants|||Number
2635780|NCT01798992|Secondary|Improvement in LVEF at 3 Months|A secondary outcome will be LVEF response at 3 months, defined as an improvement of ≥ 5% Data are not presented for non-failing controls, who only went baseline evaluation and did not undergo treatment, given that they did not have heart failure.|3 months||||LVEF responders|||Number
2635781|NCT01798992|Primary|Improvement in Left Ventricular Ejection Fraction (LVEF) at 12 Months|The primary clinical outcome will be LVEF response at 12 months defined as an improvement in LVEF of ≥ 8% at 12 months or if not available, ≥5% at 3 months in the absence of an adverse clinical outcome. Data are not presented for non-failing controls, who only went baseline evaluation and did not undergo treatment, given that they did not have heart failure.|12 months|Idiopathic dilated cardiomyopathy patients naive to beta-blocker therapy|||LVEF responders|||Number
2635782|NCT01798966|Other Pre-specified|Adverse Events and Serious Adverse Events|Safety will be evaluated throughout the duration of the study by collecting all adverse events|4 days||||Number of AE|||Number
2635783|NCT01798966|Secondary|IOP Patterns|The pattern of IOP in patients with TED will be compared with the pattern of IOP readings in normal subjects as well as glaucomatous patients|24 hours||||mvEq||Standard Deviation|Mean
2635784|NCT01798966|Primary|Change in IOP Before and After Orbital Decompression Surgery|To investigate the difference in SENSIMED Triggerfish output during transition from wake to sleep states before and after orbital decompression|24 hours||||mVEq (Sensismed Triggerfish output unit)||Standard Deviation|Median
2635785|NCT01798927|Other Pre-specified|Change in Walking Endurance by Use of 6-Minute Walk Test From Initial to Final Testing|Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary.|Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment|data from 3 of the 4 participants was analyzed|||meters||Standard Deviation|Mean
2635786|NCT01798927|Secondary|Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing|Surface electromyography will be done on key muscles in the lower extremity (quads, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in EMG activity include things such as increases in amplitude or timing that might indicate increases in strength or motor learning as a result of wearing the ankle foot orthosis.|Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment.|EMG data was analyzed from 3 of the 4 participants|||participants|||Number
2635787|NCT01798927|Primary|Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing|Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.|Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment|step length was analyzed from the GAITRite|||cm||Standard Deviation|Mean
2635788|NCT01798849|Secondary|Apparent Terminal Half-life (t1/2) of 2.0 mg MK-8892 - Healthy Participants -Fasted/Fed|Blood samples taken at Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose of each dosing period to determine the t1/2.A mixed effects model with Cohort (Healthy or hypertensive) as a fixed term, participant as a random effect was used for summary data. For participants that participated in Period 5, study drug was administered after a standard high-fat breakfast provided approximately 30 minutes prior to dosing. The meal was consumed in a 20-minute period with start and stop times being recorded. Participants were administered a single dose of MK-8892 or matching placebo Within 10 minutes of completing the meal.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose|Healthy participants (Panel A) who were administered 2.0 mg MK-8892 in both fasted and fed state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||Hours||90% Confidence Interval|Geometric Mean
2635789|NCT01798849|Secondary|Maximum Concentration (Cmax) of 2.0 mg MK-8892 - Healthy Participants- Fasted/Fed|Blood samples taken at Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose of each dosing period to determine the Cmax. A mixed effects model with Cohort (Healthy or hypertensive) as a fixed term, participant as a random effect was used for summary data. For participants that participated in Period 5, study drug was administered after a standard high-fat breakfast provided approximately 30 minutes prior to dosing. The meal was consumed in a 20-minute period with start and stop times being recorded. Participants were administered a single dose of MK-8892 or matching placebo Within 10 minutes of completing the meal.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose|Healthy participants (Panel A) who were administered 2.0 mg MK-8892 in both fasted and fed state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||nM||90% Confidence Interval|Geometric Mean
2635790|NCT01798849|Secondary|Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of 2.0 mg MK-8892 - Healthy Participants-Fasted/Fed|Blood samples taken at Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose of each dosing period to determine the AUC0-inf. A mixed effects model with Cohort (Healthy or hypertensive) as a fixed term, participant as a random effect was used for summary data. For participants that participated in Period 5, study drug was administered after a standard high-fat breakfast provided approximately 30 minutes prior to dosing. The meal was consumed in a 20-minute period with start and stop times being recorded. Participants were administered a single dose of MK-8892 or matching placebo Within 10 minutes of completing the meal.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose|Healthy participants (Panel A) who were administered 2.0 mg MK-8892 in both fasted and fed state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||nM·hr||90% Confidence Interval|Geometric Mean
2635791|NCT01798849|Secondary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Plasma Concentration Time Point (AUC0-last) of 2.0 mg MK-8892 - Healthy Participants-Fasted/Fed|Blood samples taken at Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose of each dosing period to determine the AUC0-last. A mixed effects model with Cohort (Healthy or hypertensive) as a fixed term, participant as a random effect was used for summary data. For participants that participated in Period 5, study drug was administered after a standard high-fat breakfast provided approximately 30 minutes prior to dosing. The meal was consumed in a 20-minute period with start and stop times being recorded. Participants were administered a single dose of MK-8892 or matching placebo Within 10 minutes of completing the meal.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose|Healthy participants (Panel A) who were administered 2.0 mg MK-8892 in both fasted and fed state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||nM·hr||Geometric Coefficient of Variation|Geometric Mean
2635792|NCT01798849|Secondary|Area Under the Concentration Time-curve From Hour 0 to 24 Hours (AUC0-24hr) of 2.0 mg MK-8892-Healthy Participants-Fasted/Fed|Blood samples taken at Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, and 24 hours postdose of each dosing period to determine the AUC0-24hr. A mixed effects model with Cohort (Healthy or hypertensive) as a fixed term, participant as a random effect was used for summary data. For participants that participated in Period 5, study drug was administered after a standard high-fat breakfast provided approximately 30 minutes prior to dosing. The meal was consumed in a 20-minute period with start and stop times being recorded. Participants were administered a single dose of MK-8892 or matching placebo Within 10 minutes of completing the meal.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, and 24 hours postdose|Healthy participants (Panel A) who were administered 2.0 mg MK-8892 in both fasted and fed state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||nM·hr||90% Confidence Interval|Geometric Mean
2635793|NCT01798849|Secondary|Apparent Terminal Half-life (t1/2) of MK-8892- Hypertensive Participants|Blood samples taken at Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose of each dosing period to determine the t1/2.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose|Hypertensive participants (Panel C) who were administered study drug in a fasted state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint. Includes protocol-defined 6.0 mg rechallenge.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2635794|NCT01798849|Secondary|Time to Cmax (Tmax) of MK-8892- Hypertensive Participants|Blood samples taken at Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose of each dosing period to determine the Tmax.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose|Hypertensive participants (Panel C) who were administered study drug in a fasted state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint. Includes protocol-defined 6.0 mg rechallenge.|||Hours||Full Range|Median
2635795|NCT01798849|Secondary|Maximum Concentration (Cmax) of MK-8892- Hypertensive Participants|Blood samples taken at Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose of each dosing period to determine the Cmax.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose|Hypertensive participants (Panel C) who were administered study drug in a fasted state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint. Includes protocol-defined 6.0 mg rechallenge.|||nM||Geometric Coefficient of Variation|Geometric Mean
2635796|NCT01798849|Secondary|Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of MK-8892- Hypertensive Participants|Blood samples taken at Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose of each dosing period to determine the AUC0-inf.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose|Hypertensive participants (Panel C) who were administered study drug in a fasted state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint. Includes protocol-defined 6.0 mg rechallenge.|||nM·hr||Geometric Coefficient of Variation|Geometric Mean
2635797|NCT01798849|Secondary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Plasma Concentration Time Point (AUC0-last) of MK-8892 - Hypertensive Participants|Blood samples taken at Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose of each dosing period to determine the AUC0-last.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose|Hypertensive participants (Panel C) who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||nM·hr||Geometric Coefficient of Variation|Geometric Mean
2635798|NCT01798849|Secondary|Area Under the Concentration Time-curve From Hour 0 to 24 Hours (AUC0-24hr) of MK-8892 - Hypertensive Participants|Blood samples taken at Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, and 24 hours postdose of each dosing period to determine the AUC0-24hr.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, and 24 hours postdose|Hypertensive participants (Panel C) who were administered study drug in a fasted state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint. Includes protocol-defined 6.0 mg rechallenge.|||nM·hr||Geometric Coefficient of Variation|Geometric Mean
2635799|NCT01798849|Secondary|Apparent Terminal Half-life (t1/2) of MK-8892 - Healthy Participants|Blood samples taken at Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose of each dosing period to determine the t1/2.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose|Healthy participants (Panels and B) who were administered study drug in a fasted state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2637133|NCT01784848|Secondary|Absolute Change From Baseline in Blood Pressure Levels|Change on systemic blood pressure assessed by ambulatory blood pressure monitoring (ABPM).|12, 24, 36, 48 and 60 months|||||||
2635800|NCT01798849|Secondary|Time to Cmax (Tmax) of MK-8892 - Healthy Participants|Blood samples taken at Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose of each dosing period to determine the Tmax.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose|Healthy participants (Panels and B) who were administered study drug in a fasted state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||hours||Full Range|Median
2635801|NCT01798849|Secondary|Maximum Concentration (Cmax) of MK-8892 - Healthy Participants|Blood samples taken at Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose of each dosing period to determine the Cmax.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose|Healthy participants (Panels and B) who were administered study drug in a fasted state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||nM||Geometric Coefficient of Variation|Geometric Mean
2635802|NCT01798849|Secondary|Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of MK-8892 - Healthy Participants|Blood samples taken at Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose of each dosing period to determine the AUC0-inf.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose|Healthy participants (Panels and B) who were administered study drug in a fasted state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||nM·hr||Geometric Coefficient of Variation|Geometric Mean
2635803|NCT01798849|Secondary|Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measurable Plasma Concentration Time Point (AUC0-last) of MK-8892 - Healthy Participants|Blood samples taken at Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose of each dosing period to determine the AUC0-last.|Predose and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose|Healthy participants (Panels and B) who were administered study drug in a fasted state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||nM·hr||Geometric Coefficient of Variation|Geometric Mean
2635804|NCT01798849|Secondary|Area Under the Concentration Time-curve From Hour 0 to 24 Hours (AUC0-24hr) of MK-8892 - Healthy Participants|Blood samples taken at Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24 hours postdose of each dosing period to determine the AUC0-24hr.|Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24 hours postdose|Healthy participants (Panels and B) who were administered study drug in a fasted state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||nM·hr||Geometric Coefficient of Variation|Geometric Mean
2635805|NCT01798849|Secondary|TWA0-24hr for Augmentation Index (AIx) - Hypertensive Participants|AIx was measured by applanation tonometry of the radial artery. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. The time-weighted average change from baseline was calculated by adjusting each time-point by the baseline, aggregating the area under the curve (AUC) by the trapezoidal method and then dividing the AUC by 24 hours. Negative number indicates a decrease.|Predose to 24 hours Postdose (for each Dosing Period of Each Panel)|Hypertensive participants (Panel C) who were administered study drug in a fasted state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||Percentage||Standard Error|Least Squares Mean
2635806|NCT01798849|Secondary|Change in TWA0-24hrs for Heart Rate (HR) - Hypertensive Participants|Heart rate was measured predose and every 30 minutes from 0.5-4 hours postdose; hourly from 4-12 hours postdose; every 2 hours from 12-16 hours postdose; and at 24 postdose by a validated automatic measuring device. The time-weighted average change from baseline was calculated by adjusting each time-point by the baseline, aggregating the area under the curve (AUC) by the trapezoidal method and then dividing the AUC by 24 hours. Negative number indicates a decrease.|Predose and every 30 minutes from 0.5-4 hours postdose; hourly from 4-12 hours postdose; every 2 hours from 12-16 hours postdose; and at 24 postdose (for each Dosing Period of Each Panel)|Hypertensive participants (Panel C) who were administered study drug in a fasted state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||bpm||Standard Error|Least Squares Mean
2635807|NCT01798849|Secondary|Change in TWA0-24hrs for Peripheral Diastolic Blood Pressure (pDBP) - Hypertensive Participants|Peripheral blood pressure assessments were obtained at predose and 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose by using a validated automatic measuring device. Peripheral diastolic blood pressure was measured a validated automatic measuring device. The time-weighted average change from baseline was calculated by adjusting each time-point by the baseline, aggregating the area under the curve (AUC) by the trapezoidal method and then dividing the AUC by 24 hours. Negative number indicates a decrease.|Predose (baseline) and 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose (for each Dosing Period of Each Panel)|Hypertensive participants (Panel C) who were administered study drug in a fasted state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||mm Hg||Standard Error|Least Squares Mean
2635815|NCT01798849|Primary|Percentage of Participants Who Were Discontinued From the Study Due to an AE- Healthy Participants|An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not considered related to the medicinal product. The percentage of participants that were discontinued from the study due to an AE was summarized. Adverse events were summarized by dose taken at the time of the event.|up to 7 weeks|All healthy participants (Panels A and B) who received at least 1 dose of the study drug. As pre-specified in the protocol, safety data were pooled for the MK 8892 2.0 mg fed and fasted arms only and were not planned to be provided separately.|||Percentage of Participants|||Number
2635808|NCT01798849|Secondary|Change in TWA0-24hr for Augmentation Index (AIx) - Healthy Participants|AIx was measured by applanation tonometry of the radial artery. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. The time-weighted average change from baseline was calculated by adjusting each time-point by the baseline, aggregating the area under the curve (AUC) by the trapezoidal method and then dividing the AUC by 24 hours.|Predose (baseline) and 2, 4, 12, and 24 hours postdose (for each Dosing Period of Each Panel)|Healthy participants (Panels and B) who were administered study drug in a fasted state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||Percentage||Standard Error|Least Squares Mean
2635809|NCT01798849|Secondary|Change in TWA0-24hrs for Heart Rate (HR) - Healthy Participants|Heart rate was measured predose and every 30 minutes from 0.5-4 hours postdose; hourly from 4-12 hours postdose; every 2 hours from 12-16 hours postdose; and at 24 postdose by a validated automatic measuring device. The time-weighted average change from baseline was calculated by adjusting each time-point by the baseline, aggregating the area under the curve (AUC) by the trapezoidal method and then dividing the AUC by 24 hours. A negative number indicates a decrease.|Predose (baseline) and every 30 minutes from 0.5-4 hours postdose; hourly from 4-12 hours postdose; every 2 hours from 12-16 hours postdose; and at 24 postdose (for each Dosing Period of Each Panel)|Healthy participants (Panels and B) who were administered study drug in a fasted state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2635810|NCT01798849|Secondary|Change in TWA0-24hrs for Peripheral Diastolic Blood Pressure (pDBP) - Healthy Participants|Peripheral diastolic blood pressure was measured using a validated automatic measuring device. The time-weighted average change from baseline was calculated by adjusting each time-point by the baseline, aggregating the area under the curve (AUC) by the trapezoidal method and then dividing the AUC by 24 hours. A negative number indicates a decrease.|Predose and 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose (for each Dosing Period of Each Panel)|Healthy participants (Panels and B) who were administered study drug in a fasted state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||mm Hg||Standard Error|Least Squares Mean
2635811|NCT01798849|Primary|Change in 24-hour Time-weighted Average (TWA0-24hr) for Central Diastolic Blood Pressure (cDBP) - Hypertensive Participants|Central diastolic blood pressure measurements were obtained at predose and 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose via applanation tonometry of the radial artery. The average central diastolic blood pressure over the 24-hour monitoring period was calculated for each dose of each panel by adjusting each time-point by the baseline, aggregating the area under the curve (AUC) by the trapezoidal method and then dividing the AUC by 24 hours. A negative number indicates a decrease.|Predose (baseline) and 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose (for each Dosing Period)|Hypertensive participants (Panel C) who were administered study drug in a fasted state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||mm Hg||Standard Error|Least Squares Mean
2635812|NCT01798849|Primary|Percentage of Participants Who Were Discontinued From the Due to an AE - Hypertensive Participants|An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants that were discontinued from the study due to an AE was summarized. Adverse events were summarized by dose taken at the time of the event.|up to 7 weeks|All hypertensive participants (Panel C) who received at least 1 dose of the study drug in a fasted state.|||Percentage of Participants|||Number
2635813|NCT01798849|Primary|Percentage of Participants Who Report 1 or More Adverse Events (AEs) - Hypertensive Participants|An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized. Adverse events were summarized by dose taken at the time of the event.|up to 7 weeks|All hypertensive participants (Panel C) who received at least 1 dose of the study drug in a fasted state.|||Percentage of Participants|||Number
2635814|NCT01798849|Primary|Change in 24-hour Time-weighted Average (TWA0-24hr) for Central Diastolic Blood Pressure (cDBP)- Healthy Participants|Central diastolic blood pressure measurements were obtained at predose and at 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose via applanation tonometry of the radial artery. The average central diastolic blood pressure over the 24-hour monitoring period was calculated for each dose of each panel by adjusting each time-point by the baseline, aggregating the area under the curve (AUC) by the trapezoidal method and then dividing the AUC by 24 hours. A negative number indicates a decrease.|Predose (baseline) and 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose (for each Dosing Period of Each Panel)|Healthy participants (Panels A and B) who were administered study drug in a fasted state, who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of the treatment, according to the underlying scientific model and had data available for endpoint.|||mm Hg||Standard Error|Least Squares Mean
2635816|NCT01798849|Primary|Percentage of Participants Who Report 1 or More Adverse Events (AEs)- Healthy Participants|An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants that reported at least 1 AE was summarized. Adverse events were summarized by dose taken at the time of the event.|up to 7 weeks|All healthy participants (Panels A and B) who received at least 1 dose of the study drug. As pre-specified in the protocol, safety data were pooled for the MK 8892 2.0 mg fed and fasted arms only and were not planned to be provided separately.|||Percentage of Participants|||Number
2635818|NCT01798706|Secondary|Percentage of Participants With HbA1c Reduction >0.5% at Week 24 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia|The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug.|Week 24|mITT population. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.|||percentage of participants|||Number
2635819|NCT01798706|Secondary|Percentage of Participants With Symptomatic and Severe Symptomatic Hypoglycemia|Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration (maximum of 171 days)|Analysis was performed on safety population defined as all randomized participants who received any amount of study drug.|||percentage of participants|||Number
2635820|NCT01798706|Secondary|Change in Total Daily Basal Insulin Dose From Baseline to Week 24 (in Participants Who Took Basal Insulin as Background Therapy)|Change in basal insulin dose was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline basal insulin dose assessment during on-treatment period.|||units||Standard Error|Least Squares Mean
2635821|NCT01798706|Secondary|Change in Plasma Glucose Excursions From Baseline to Week 24|Plasma glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the liquid standardized breakfast meal test, before study drug administration. Change in plasma glucose excursions were calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants=participants with baseline and at least one post-baseline plasma glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2635822|NCT01798706|Secondary|Percentage of Participants Requiring Rescue Therapy During 24 Week Treatment Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values - from baseline to Week 8: fasting SMPG/FPG >270 mg/dL (15.0 mmol/L), from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 24: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >9%.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
2635823|NCT01798706|Secondary|Change in FPG From Baseline to Week 24|Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2635824|NCT01798706|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline body weight assessment during on-treatment period.|||kg||Standard Error|Least Squares Mean
2635825|NCT01798706|Secondary|Change in Average 7-point SMPG Profiles From Baseline to Week 24|Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2635826|NCT01798706|Secondary|Change in 2-Hour PPG From Baseline to Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a liquid standardized breakfast meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 24|mITT population. Here, number of participants analyzed=participants with baseline and at least one post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2635827|NCT01798706|Primary|Absolute Change in HbA1c From Baseline to Week 24|Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed=participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.|Baseline, Week 24|Modified intent to treat (mITT) population: all randomized participants who received at least one dose of study drug; and had both baseline and at least one post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2635828|NCT01798641|Primary|Kubo Score on Open Shunt vs. Closed Shunt|The Kubo tool measures your symptoms in three categories: cognitive (attention and memory), gait/balance and urinary function.The score ranges from 0 to 24 with higher scores indicating worse symptoms|6 weeks|Only 11 participants were analyzed from each group. The rest were lost to follow up.|||score on a scale||Inter-Quartile Range|Median
2635829|NCT01798641|Primary|Kiefer Score on Open Shunt vs. Closed Shunt|The Kiefer is a modified clinical grading tool that measures the severity of the three key symptoms (mental deficits, gait disturbance, incontinence) and two additional minor symptoms (headache and dizziness). The overall score may reach values between 0 and 24, with higher scores indicating more severe impairment|6 weeks|Only 11 participants were analyzed from each arm. The remaining were lost to follow up|||score on a scale||Inter-Quartile Range|Median
2635830|NCT01798641|Primary|Medical College of Virginia (MCV) Gait Grade on Open Shunt vs. Closed Shunt|The MCV gait grade evaluation measures balance and walking. The score ranges from 1 to 6 with higher values suggesting worse gait performance.|6 weeks|Only 8 from each closed shunt group were analyzed. The rest were lost to follow up|||score on a scale||Inter-Quartile Range|Median
2635831|NCT01798641|Primary|Timed Up and Go (TUG) Score on Open Shunt vs. Closed Shunt|The TUG evaluation measures walking and balance. The patient is timed while they rise from an arm chair (approximate seat height 46 cm), walk at a comfortable and safe pace to a line on the floor three meters away, turn and walk back to the chair and sit down again. The patient walks through the test once before being timed to become familiar with the test. The subject wears his regular footwear and uses a walking aid (cane or walker) if necessary. A faster time indicates a better functional performance and a score of ≥13.5 seconds is used as a cut-point to identify those at increased risk of falls.|6 weeks|Only 7 participants were analyzed from the open shunt group. Only 10 were analyzed from the closed shunt group. The rest were lost to follow up|||seconds||Inter-Quartile Range|Median
2635832|NCT01798641|Primary|Tinetti Score on Open Shunt vs. Closed Shunt|The Tinetti tool test measures walking and balance. It is designed to determine an elders risk for falls within the next year. It takes about 8-10 minutes to complete. The patient is asked to complete the gait portion first with the evaluator walking close behind the elder and evaluating gait steppage and drift. The patient is then asked to complete the balance portion with the evaluator again standing close by the patient (towards the right and in front). The patient is then asked to sit and the score is then totaled.The higher the score, the better the performance. Scoring is done on a three point scale with a range on each item of 0-2 with 0 representing the most impairment. Individual scores are then combined to form three scales: a Gait Scale, a Balance Scale and then and overall Gait and Balance score. The maximum score for gait is 12 points while the maximum for Balance is 16 points with a total maximum for the overall score of 28 points.|6 weeks|Only 10 participants were analyzed from each group. The rest were lost to follow up|||score on a scale||Inter-Quartile Range|Mean
2635833|NCT01798550|Other Pre-specified|Proportion of Patients With Major and Minor Bleeding Events Prior to Achieving a Therapeutic Level||Hemoglobin and platelets were assessed at baseline and daily as indicated while on study up to 30 days||||Participants|||Count of Participants
2635834|NCT01798550|Other Pre-specified|Number of Patients Requiring Dose Adjustments to Achieve Therapeutic Anti-Xa Level||Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days||||Participants|||Count of Participants
2635835|NCT01798550|Other Pre-specified|Median Steady State Anti-Xa Levels|The goal anti-Xa peak level range was defined as 0.5 - 1.1 International units/mL. The Anti-Xa was assessed 3-5 hours after at least three consecutive enoxaparin doses. If a dose adjustment was needed, the anti-Xa level was drawn four hours after the adjusted dose of enoxaparin was administered. Dose adjustments were made until a therapeutic level within goal range was obtained.|Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days||||IU/mL||Inter-Quartile Range|Median
2635836|NCT01798550|Secondary|Time to Therapeutic Anti-Xa Level for Both Groups|Time to therapeutic Anti-Xa = time in hours from enoxaparin dose #1 to the first therapeutic Anti-Xa. The Anti-Xa was assessed 3-5 hours after at least three consecutive enoxaparin doses. If a dose adjustment was needed, the anti-Xa level was drawn four hours after the adjusted dose of enoxaparin was administered. Dose adjustments were made until a therapeutic level within goal range was obtained.|Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days||||hours||Inter-Quartile Range|Median
2635837|NCT01798550|Primary|Proportion of Patients With an Initial Therapeutic Anti-Xa Level at Steady State in Each Group||3-5 hours after at least 3rd dose||||Participants|||Count of Participants
2635838|NCT01798485|Secondary|Patient-Reported Symptom Improvement as Measured by the Functional Assessment of Cancer Therapy - Lung (FACT-L) Version 4 Test|"The FACT-L contains 4 general subscales and a Lung Cancer Subscale (LCS). General subscales include: Physical Well-Being (PWB), Social/ Family Well-Being (SWB), Emotional Well-Being (EWB), and Functional Well-Being (FWB). The LCS assesses symptoms commonly reported by lung cancer patients (e.g., shortness of breath, weight loss, and tightness in the chest). The FACT-L total score ranges from 0 to 136, higher scores represent better QOL.~Data were not summarized due to the early termination of the study due to futility."|Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial|Randomized participants||||||
2635839|NCT01798485|Secondary|Patient-Reported Quality of Life as Measured by the European Quality Of Life - Five Dimensions - Three Levels (EQ-5D-3L) Survey|"The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. An overall EQ-5D-3L index was calculated (see EuroQoL website, http://www.euroqol.org/eq-5d-products/eq-5d-3l.html), with an index of 1.0 representing full health and and 0 represents dead, with some health states being worse than dead (<0).~This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis."|Day 1 (pre-treatment), Day 63 (Cycle 3 Day 1), Day 105 (Cycle 5 Day 1) and end of trial|Randomized participants. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.||||||
2635840|NCT01798485|Secondary|Participants With Treatment-Emergent Adverse Events as of 23 December 2015|"Treatment-emergent adverse events (AEs) were defined as AEs that occurred from the time of first dose through 30 days after the last dose of study medication. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria:~Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death A Serious AE (SAE) is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event."|up to 36 months|Safety population|||participants|||Number
2635841|NCT01798485|Other Pre-specified|Exploratory Biomarker Analyses|Exploratory biomarker analyses was to assess correlation between biomarkers and clinical outcome. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.|up to 36 months|Randomized||||||
2635842|NCT01798485|Secondary|Percentage of Participants With Progressive Disease Due to Any New Metastatic Lesion as of 19 October 2015|Progressive disease was due to either new metastatic lesions only or new metastatic lesions and target tumor growth.|up to 36 months|Randomized participants|||percentage of participants|||Number
2635843|NCT01798485|Secondary|Kaplan-Meier Estimate for Time to Emergence of New Metastatic Lesion (TNL) as of 19 October 2015|TNL was defined as time from the randomization date to the first day of radiological progression that included new metastatic lesions. Participants with no new metastatic lesions were censored at the date of the most recent radiological assessment.|up to 36 months|Randomized participants|||months||95% Confidence Interval|Median
2635844|NCT01798485|Secondary|Disease Control Rate (DCR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015|"Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was a complete response (CR), a partial response (PR), or stable disease (SD).~CR was defined as the disappearance (or normalization) of all target lesions.~PR was defined as <=30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.~SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of diameters while on study. The duration of SD must be for at least 6 weeks or 12 weeks.~Elevated LDH includes values above the upper limit of normal.~This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis."|up to 36 months|Randomized participants who had an elevated screening LDH. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.||||||
2635845|NCT01798485|Secondary|Objective Response Rate (ORR) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015|"Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR) or a partial response (PR).~CR was defined as the disappearance (or normalization) of all target lesions.~PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.~Elevated LDH includes values above the upper limit of normal.~This study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis."|up to 36 months|Randomized participants who had an elevated screening LDH. However, this study stopped prematurely due to futility and development of this product ceased. The sponsor made a decision at that time to not analyze this outcome. The sponsor no longer has staff or capabilities for further analysis.||||||
2635846|NCT01798485|Secondary|Progression Free Survival (PFS) in Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015|"The progression-free interval is the interval from the date of randomization until tumor progression per modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), clinical progression, or death from any cause in the absence of progressive disease, whichever occurs first. Data represents the investigator's assessment.~Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Elevated LDH includes values above the upper limit of normal."|up to 36 months|Randomized participants who had an elevated screening LDH|||months||95% Confidence Interval|Median
2635847|NCT01798485|Secondary|Kaplan-Meier Estimate of Duration of Response (DOR) as of 19 October 2015|"Only participants who achieved a confirmed response (complete response (CR) or partial response (PR)) were included in the DOR analysis.~CR was defined as the disappearance (or normalization) of all target lesions.~PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters."|up to 36 months|Randomized participants who had a confirmed response|||months||95% Confidence Interval|Median
2635848|NCT01798485|Secondary|Disease Control Rate (DCR) as of 19 October 2015|"Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR), a partial response (PR), or stable disease (SD).~CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.~SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of diameters while on study. For participants with a best response of SD, duration of SD must be for at least 6 weeks or 12 weeks."|up to 36 months|Randomized participants|||percentage of participants||95% Confidence Interval|Number
2635875|NCT01798186|Primary|Delta-9-tetrahydrocannabinol (THC) Cmax in Blood|After exposure to cannabis, we will conduct a pharmacokinetic analysis of THC in blood collected.|0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 22, 26, 30, and 34 hours post cannabis exposure||||ng/mL||Standard Deviation|Mean
2635876|NCT01798134|Secondary|12 Month Survival||12 months||||participants|||Number
2635849|NCT01798485|Secondary|Objective Response Rate (ORR) as of 19 October 2015|"Percentage of participants whose best overall response, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), was either a complete response (CR) or a partial response (PR).~CR was defined as the disappearance (or normalization) of all target lesions. PR was defined as at least 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters."|up to 36 months|Randomized participants|||percentage of participants||95% Confidence Interval|Number
2635850|NCT01798485|Secondary|Overall Survival (OS) In Participants With an Elevated Screening Lactate Dehydrogenase (eLDH) as of 19 October 2015|OS was measured from the date of randomization to the date of death from any cause. Elevated LDH includes values above the upper limit of normal.|up to 36 months|Randomized participants with elevated LDH at screening|||months||95% Confidence Interval|Median
2635851|NCT01798485|Secondary|Progression-free Survival (PFS) as of 19 October 2015|"The progression-free interval is the interval from the date of randomization until tumor progression per modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), clinical progression, or death from any cause in the absence of progressive disease, whichever occurs first. Data represents the investigator's assessment.~Progressive Disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm."|up to 36 months|Randomized participants|||months||95% Confidence Interval|Median
2635852|NCT01798485|Primary|Overall Survival as of 19 October 2015|Overall survival (OS) was measured from the date of randomization to the date of death from any cause.|up to 36 months|Randomized participants|||months||95% Confidence Interval|Median
2635853|NCT01798394|Secondary|Protocol Compliance - EDC's Completed|Compliance was measured as the number by number of EDCs completed (maximum of 84).|Gestational Week 36 - Postpartum Week 12||||EDC's completed||Standard Deviation|Mean
2635854|NCT01798394|Secondary|Protocol Compliance - Doses of Medication Taken|Compliance was measured by doses of medication taken (maximum of 56).|Postpartum Week 0 - Week 12||||Doses of medication taken||Standard Deviation|Mean
2635855|NCT01798394|Secondary|Compliance Determinants|This was determined by the Feasibility Questionnaire; a 10-item measure used to assess participant expectations, satisfaction of study protocol, study medication and electronic data capture. All questions were answered on a four-point Likert-type scale (1=low acceptability and 4=high acceptability). The total score was determined by adding up all the scores and dividing by 10.|Postpartum Week 12||||units on a scale||Standard Deviation|Mean
2635856|NCT01798394|Secondary|Protocol Compliance - Number of Visits Attended|Compliance was measured as the number of visits attended (maximum of 5).|Gestational Week 36 - Postpartum Week 12||||Number of visits attended||Standard Deviation|Mean
2635857|NCT01798394|Secondary|Number of Participants Who Relapsed at All During Postpartum (up to Day 84)|Defined by continuous abstinence (CA) defined as a single puff of a cigarette as a relapse.|Postpartum Day 0 to 84||||participants|||Number
2635858|NCT01798394|Secondary|Number of Participants Who Relapsed by Week 12 Postpartum|Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.|Week 12 Postpartum||||participants|||Number
2635859|NCT01798394|Primary|Number of Participants Who Relapsed by Week 4 Postpartum|Determined by seven-day point prevalence, a binary smoking relapse outcome - defined as a single puff of a cigarette during the seven days prior to a pre-specified time point of interest.|Week 4 Postpartum||||participants|||Number
2635860|NCT01798316|Other Pre-specified|Narcotic Use During PACU Stay|Narcotic medication administered during PACU stay in morphine milligram equivalents|4 hours plus/minus 30 minutes||||Morphine milligram equivalents||95% Confidence Interval|Mean
2635861|NCT01798316|Other Pre-specified|Number of Patients Requiring Rescue Analgesia for Breakthrough Pain|Number of patients requiring rescue analgesia medication during first hour of PACU stay|1 hour following surgery||||Participants|||Count of Participants
2635862|NCT01798316|Secondary|Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale|Pain intensity score reported by participants 1 hour following surgery using an 11-point, 0-10 Numeric Rating Scale (NRS). Higher scores indicate higher pain intensities|1 hour following surgery||||Units on a numerical rating scale||Inter-Quartile Range|Median
2635863|NCT01798316|Secondary|Patient Satisfaction on a 5 Point Likert Scale|Number of patients very satisfied or satisfied with pain and PONV management during hospital stay|Up to one week following surgery|Post-discharge follow up group. Patients not included in analysis were lost to follow up.|||Participants|||Count of Participants
2635864|NCT01798316|Secondary|Highest Pain Intensity Score Using Numeric Rating Scale (NRS)|Highest pain intensity reported during PACU stay using a 11-point (0-10) pain intensity numeric rating scale (NRS). Higher values represent higher pain intensities.|4 hours plus/minus 30 minutes||||Units on a numerical rating scale||Inter-Quartile Range|Median
2635865|NCT01798316|Secondary|Number of Participants With Post Discharge Nausea and Vomiting (PDNV)|"Number of participants reporting post discharge nausea and vomiting (PDNV) documented up to 2 days following surgery.~PDNV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching following discharge."|Up to two days following surgery|Post-discharge follow up group. Patients not included in analysis were lost to follow up.|||Participants|||Count of Participants
2635866|NCT01798316|Primary|Number of Participants With Postoperative Nausea and Vomiting (PONV).|"Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay.~PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching."|4 hours plus/minus 30 minutes||||Participants|||Count of Participants
2635867|NCT01798264|Secondary|Change in Weight From Baseline to 4 Weeks||4 weeks||||kg||Standard Deviation|Mean
2635868|NCT01798264|Secondary|Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline||4 weeks||||mg/dL||Standard Deviation|Mean
2635869|NCT01798264|Secondary|To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus|Change in HbA1c from baseline|4 weeks||||percentage||Standard Deviation|Mean
2635870|NCT01798264|Primary|Number of Subjects With Study Drug-Related Adverse Events||4 weeks|Number of subjects reporting study drug-related adverse events|||participants|||Number
2635877|NCT01798134|Primary|Freedom From Tumor Progression at 6 Months|Progression was assessed by the modified Response Evaluation Criteria in Solid Tumors (mRECIST - Lencioni and Llovet 2010) as an increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.|6 months|For efficacy outcomes, there were 21 participants with imaging to assess tumor response. No imaging was available for the other participants.|||participants|||Number
2635878|NCT01798134|Primary|Freedom From Study Related SAE at 6 Months||Up to 6 months|One participant is not included in the analysis as the investigator withdrew the participant 2 days after treatment started and then treated the participant systemically with sorafenib.|||participants|||Number
2635879|NCT01798134|Primary|Freedom From Serious Adverse Event (SAE) at 30days||Up to 30 days|One participant is not included in the analysis as the investigator withdrew the participant 2 days after treatment started and then treated the participant systemically with sorafenib.|||participants|||Number
2635880|NCT01798056|Secondary|Number of Subjects With Any Potential Immune Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From 30 days post last vaccination up to study end (Month 13)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered.|||Participants|||Count of Participants
2635881|NCT01798056|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE = SAE assessed by the investigator as causally related to the study vaccination.|From 30 days post last vaccination up to study end (Month 13)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered.|||Participants|||Count of Participants
2635882|NCT01798056|Secondary|Number of Subjects With Vaccine Responses for gE-specific CD4[2+] T-cells in PreChemo Groups|Vaccine response defined as: For initially seronegative subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x320 Events/10E6 CD4+ T cells); For initially seropositive subjects with pre-vaccination T-cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies.|At Months 1, 2 and 13|The analysis was performed on the PreChemo groups from the Adapted ATP cohort for Cell Mediated Immunity (CMI) immunogenicity which included all evaluable subjects for which the active phase time points Months 0, 1 and 2 data were obtained from the ATP cohort for CMI immunogenicity.|||Participants|||Count of Participants
2635883|NCT01798056|Secondary|Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups|Descriptive statistics were tabulated for CD4[2+] cells, which are gE-specific CD4+ T-cells with at least 2 activation markers ([2+]) expressed from the activation markers IFN-γ, IL-2, TNF-α and CD40 L, as determined by intra-cellular staining (ICS) method.|At Months 0, 1, 2 and 13|The analysis was performed on the PreChemo groups from the Adapted ATP cohort for Cell Mediated Immunity (CMI) immunogenicity which included all evaluable subjects for which the active phase time points Months 0, 1 and 2 data were obtained from the ATP cohort for CMI immunogenicity.|||CD4 T-cells/million T-cells||Inter-Quartile Range|Median
2635884|NCT01798056|Secondary|Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations|Vaccine response defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/ml); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.|At Months 1, 2, 6 and 13|The analysis was performed on the Adapted ATP cohort for Humoral immunogenicity which included all evaluable subjects for which the active phase time points Months 0, 1 and 2 data were obtained from the ATP cohort for Humoral Immunogenicity.|||Participants|||Count of Participants
2635885|NCT01798056|Secondary|Anti-VZV gE Antibody Concentrations|Antibody concentrations as determined by ELISA are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU//mL.|At Months 0, 1, 6 and 13|The analysis was performed on the Adapted ATP cohort for Humoral immunogenicity which included all evaluable subjects for which the active phase time points Months 0, 1 and 2 data were obtained from the ATP cohort for Humoral Immunogenicity.|||mIU/mL||95% Confidence Interval|Geometric Mean
2635886|NCT01798056|Primary|Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related = pIMDs assessed by the investigator as causally related to the study vaccination.|From first vaccination up to 30 days post last vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered|||Participants|||Count of Participants
2635887|NCT01798056|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAE= SAE assessed by the investigator as causally related to the study vaccination.|From first dose up to 30 days post last vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered.|||Participants|||Count of Participants
2635888|NCT01798056|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered.|||Participants|||Count of Participants
2635889|NCT01798056|Primary|Number of Days With Solicited General Symptoms|The number of days with any general symptoms has been assessed during the post-vaccination period.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered, who had their symptom sheets filled in.|||Days|Doses with the symptom|Inter-Quartile Range|Median
2635890|NCT01798056|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal [symptoms included nausea, vomiting, diarrhoea and/or abdominal pain], headache, myalgia, shivering and fever [defined as oral, axillary or timpanic temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered, who had their symptom sheets filled in.|||Participants|||Count of Participants
2635891|NCT01798056|Primary|Number of Days With Solicited Local Symptoms|The number of days with any local symptoms has been assessed during the post-vaccination period.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered, who had their symptom sheets filled in.|||Days|Doses with the symptom|Inter-Quartile Range|Median
2635892|NCT01798056|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of study vaccine administered, who had their symptom sheets filled in.|||Participants|||Count of Participants
2635893|NCT01798056|Primary|Anti-Varicella Zoster Virus (VZV) gE Antibody Concentrations|Antibody concentrations as determined by ELISA are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU//mL.|At Month 2|The analysis was performed on the ATP cohort for Humoral immunogenicity which included all evaluable subjects for which the active phase time point Month 2 data were obtained from the ATP cohort for Humoral Immunogenicity.|||mIU/mL||95% Confidence Interval|Geometric Mean
2635894|NCT01798056|Primary|Adjusted Geometric Means for Anti-glycoprotein E (gE) Antibodies in PreChemo Groups|Adjusted geometric means (GMC) of GSK1437173A over placebo for anti-glycoprotein E (gE) antibody enzyme-linked immunosorbent assay (ELISA) concentrations in PreChemo Groups only.|At Month 2|The analysis was performed on the PreChemo groups from the According-to-Protocol (ATP) cohort for Humoral immunogenicity which included all evaluable subjects up to 30 days post last vaccination and who had met all eligibility criteria and complied with the procedures and intervals defined in the protocol for active phase of the study.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2635895|NCT01798004|Other Pre-specified|Melphalan Pharmacokinetics and the Combination of Busulfan and Melphalan AUC (Optional)|A descriptive analysis of the relationship between melphalan pharmacokinetics and the combination of busulfan and melphalan AUC with the occurrence of non-hematologic toxicities within 28 days following completion of consolidation will be assessed. In addition, the association between melphalan exposure levels as measured by the AUC and event-free survival and overall survival will be examined using Cox proportional hazards models.|Within 28 days post-consolidation|||||||
2635896|NCT01798004|Other Pre-specified|Proportion of High-risk Neuroblastoma Patients With MYCN Non-amplified Tumors for Whom Molecular Profiling Results Can be Obtained||Within 8 weeks of diagnosis|||||||
2635897|NCT01798004|Other Pre-specified|Proportion of High-risk Neuroblastoma Patients for Whom ALK Status Can be Obtained||Within 6 weeks of diagnosis|||||||
2635898|NCT01798004|Other Pre-specified|Percentage of MIBG Scans Receiving Institutionally and Centrally Reviewed and Automated Advanced Assisted Scoring Platform Curie Scores Within 1 Unit of Each Other|Cohen's kappa will be calculated to evaluate the concordance in Curie scores between each of the scoring methods at each time point. Up to 160 MIBG scans are expected at diagnosis and up to 144 MIBG scans from the 90% of patients estimated to be MIBG avid are projected post-course 4 of induction therapy, for a total of up to 304 MIBG scans.|Up to week 12 (course 4 of induction therapy)|||||||
2635899|NCT01798004|Other Pre-specified|"Percentage of Centrally Reviewed Post-course 4 MIBG Scans Reporting a Curie Score Considered to Have Been Determined in Real Time"||Up to week 12 (course 4 of induction therapy)|||||||
2635900|NCT01798004|Other Pre-specified|First Dose Area Under the Curve (AUC) and Average Daily AUC for Busulfan|Relationship with occurrence of non-hematologic toxicities assessed by a descriptive analysis. Association between busulfan exposure levels as measured by the area under the curve (AUC) and event-free survival and overall survival will be examined using Cox proportional hazards models.|Within 28 days following consolidation|||||||
2635901|NCT01798004|Other Pre-specified|Overall Survival||Up to 5 years|||||||
2635902|NCT01798004|Other Pre-specified|EFS||Up to 5 years|||||||
2635903|NCT01798004|Other Pre-specified|Response Rate Determined Using the International Response Criteria||Up to 5 years|||||||
2635904|NCT01798004|Other Pre-specified|Incidence of Non-hematologic Organ Toxicity (Grade 3 and Higher) and All Cause Mortality Graded According to CTC v4.0|"Assessed by a descriptive analysis of the incidence of grade 3-5 non-hematologic toxicities (CTC v4.0) and all-cause mortality during consolidation therapy. In addition, a descriptive analysis of late onset grade 4-5 pulmonary and hepatic complications that occur within 180 days of the start of consolidation therapy will be examined, regardless if the patient has proceeded to other therapy (including chimeric antibody) during that 180 day period."|Up to 180 days|||||||
2635976|NCT01797471|Secondary|Overall Survival (OS)|Rate of overall survival (OS) in study participants. Overall survival is defined as the length of time from the date of treatment initiation until the date of death from any cause.|Assessed up to 2 years|A minimum sample size of 10 study participants was required for the analysis of the outcome measure. Minimum enrollment was not met, therefore, the data were not analyzed.||||||
2635905|NCT01798004|Primary|The Tolerability of BuMel Regimen|Number of patients who experience one or more unacceptable toxicities (severe sinusoidal obstruction syndrome [SOS] or Grade 4-5 pulmonary toxicity per Common Toxicity Criteria [CTC] v.4.0) during the Consolidation phase of therapy.|Up to 28 days post-consolidation therapy, up to 1 year|All eligible and evaluable patients who received at least one dose of either busulfan or melphalan.|||participants|||Number
2635906|NCT01797965|Secondary|Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period|The PASAT 3 assesses auditory information processing speed. A random series of numbers from 1 to 9, inclusive, are presented and the participant is instructed to consecutively add pairs of numbers so that each number is added to the one that immediately preceded it. In the 3- second PASAT, numbers are presented at a rate of 1 every 3 seconds. The total possible score is the number of correct responses from 0 to 60 (best). A positive change from baseline indicates improvement.|Baseline 301, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 in the 301 study, Baseline 303, Weeks 12, 24, 48, 120, 144,168, 192, 216, 240 in 303 study|301-303 ITT Population consisted of all participants who completed study 301 and had at least 1 dose of DAC HYP during study 303. Number analyzed is the number of participants with data available at the given timepoint.|||score on a scale||Full Range|Median
2635907|NCT01797965|Secondary|Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period|The PASAT 3 assesses auditory information processing speed. A random series of numbers from 1 to 9, inclusive, are presented and the participant is instructed to consecutively add pairs of numbers so that each number is added to the one that immediately preceded it. In the 3- second PASAT, numbers are presented at a rate of 1 every 3 seconds. The total possible score is the number of correct responses from 0 to 60 (best). A positive change from baseline indicates improvement.|Baseline 303, Weeks 12, 24, 48, 120, 144, 168, 192, 216, 240 in 303|301-303 ITT Population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected for participants from the 203 and 302 studies.|||score on a scale||Full Range|Median
2635908|NCT01797965|Secondary|Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period|SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best). A positive change from baseline indicates improvement.|Baseline 301, Weeks 24, 48, 72, 96, 120, 144 in 301; Weeks 144, 168, 192, 216, 240 in 303|301-303 ITT Population consisted of all participants who completed Study 301 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.|||score on a scale||Standard Deviation|Mean
2635909|NCT01797965|Secondary|Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period|SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best). A positive change from baseline indicates improvement.|Baseline 303, Weeks 144, 168, 192, 240 in 303|ITT Population: All participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data is collected for participants from 203 and 302 studies.|||score on a scale||Standard Deviation|Mean
2635910|NCT01797965|Secondary|Number of Participants With Anti-BIIB019 Neutralizing Antibodies (Nabs) in the 205MS303 Treatment Period|Blood samples were collected for NAbs and were analyzed using a laboratory test. The number of participants NAb positive at any post-baseline timepoint is reported.|Up to 4.6 years in the 303 Treatment Period|Safety Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number of participants analyzed is the number of participants with evaluable data for this outcome measure.|||Participants|||Count of Participants
2635911|NCT01797965|Secondary|Number of Participants With Anti-BIIB019 Binding Antibodies (ADAbs) in the 205MS303 Treatment Period|Blood samples were collected for ADAbs and were analyzed using a laboratory test. The number of participants ADAb positive at any post-baseline timepoint is reported.|Up to 4.6 years in the 303 Treatment Period|Safety Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number of participants analyzed is the number of participants with evaluable data for this outcome measure.|||Participants|||Count of Participants
2635912|NCT01797965|Secondary|Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories|The investigator assessed the injection site after the first dose and before the fourth dose for the presence of erythema (None, Mild, Moderate, Severe), pigmentation (None, Hypo, Hyper), Induration (None, Mild, Moderate, Severe), Tenderness (None, Mild, Moderate, Severe) and Temperature (Normal, Warm, Hot). The number of participants in each grade is reported.|After the first and fourth injections in 303, approximately Week 0 and Week 12|Safety Population included all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Local tolerability of the DAC HYP injection was assessed for all participants who received DAC HYP in Study 303 with data available at the given timepoint and is independent of the treatment previously received.|||Participants|||Count of Participants
2635913|NCT01797965|Secondary|Local Tolerability as Assessed by Participant-reported Injection Site Pain VAS|The VAS is a 10 cm-long horizontal line labeled with 2 extremes of pain at either end: 0 =no pain on the left and 100=very painful on the right. The participant rates their perceived pain of each injection by placing a vertical mark on the line to indicate the level of pain.|After the first and fourth injections in 303, approximately Week 0 and Week 12|Safety Population consisted of all participants who completed Study 301,203 or 302 and received at least one dose of DAC HYP in Study 303. Local tolerability of the DAC HYP injection was assessed for all participants who received DAC HYP in Study 303 with data available at the given timepoint and is independent of the treatment previously received.|||score on scale||Standard Deviation|Mean
2635914|NCT01797965|Secondary|Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Assessments in the 205MS303 Treatment Period|Clinical Laboratory assessments included tests of hematology, blood chemistry, renal function, and thyroid function. The investigator determined if the results were clinically significant.|Up to 4.6 years in 303|Safety Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303.|||Participants|||Count of Participants
2635915|NCT01797965|Secondary|HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period|The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant assessed the percent impact of MS and its treatments on how much they accomplished using a VAS where 0= MS or its treatments had no impact on how much I accomplished to 100=MS or its treatments kept me from accomplishing anything.|301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303|ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.|||percent impact||Standard Deviation|Mean
2635916|NCT01797965|Secondary|HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period|The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded the hours where they were not able to perform household chores due to MS or its treatments.|301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303|ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants unable to complete chores with data available at the given timepoint.|||hours||Standard Deviation|Mean
2635917|NCT01797965|Secondary|HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period|The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded whether MS or its treatments kept them from completing household chores.|301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303|ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.|||Participants|||Count of Participants
2635918|NCT01797965|Secondary|HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period|The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded their planned hours for household chores.|301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303|ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.|||hours||Standard Deviation|Mean
2635919|NCT01797965|Secondary|HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period|The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participants assessed the percent impact of MS and its treatments on their work output using a VAS where 0= MS or its treatments had no impact on how much I accomplished to 100=MS or its treatments kept me from accomplishing anything. Data is reported for part time or full time employment.|301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303|ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.|||percent impact||Standard Deviation|Mean
2635920|NCT01797965|Secondary|HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period|The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded the hours they missed work due to MS or its treatments. Data is reported by part time or full time employment.|301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303|ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants who missed work with data available at the given timepoint.|||hours||Standard Deviation|Mean
2635921|NCT01797965|Secondary|HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period|The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded whether their MS or its treatments caused them to miss work. Data is reported by part time or full time employment.|301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303|ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.|||Participants|||Count of Participants
2635922|NCT01797965|Secondary|Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period|The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded their scheduled work hours. Data is reported by part time or full time employment.|301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303|ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.|||hours||Standard Deviation|Mean
2635923|NCT01797965|Secondary|Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period|"Participants answered the question: How satisfied or dissatisfied are you with the ability of the medication to prevent or treat the condition? using the following scale: Dissatisfied (Extremely dissatisfied, Very dissatisfied, Dissatisfied) or Satisfied (Somewhat satisfied, Satisfied, Very Satisfied and Extremely satisfied). The number of participants in the Dissatisfied and Satisfied categories is reported."|Baseline 303, Weeks 12, 24, 48, 72, 96, 120 in Study 303|301-303 ITT Population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected for participants from the 203 and 302 studies.|||Participants|||Count of Participants
2636012|NCT01797263|Secondary|PTSD Checklist of Symptoms|This 17-item scale assess PTSD symptom severity and provides a severity score; with higher scores representing more severe PTSD. Min: 0, Max: 85 with higher scores representing more severity.|3 Month|"This measure was completed in those participants who screened positive for PTSD"|||units on a scale||Standard Deviation|Mean
2635924|NCT01797965|Secondary|Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period|Heath resource utilization was assessed by the number of hospitalizations, emergency room visits, and unscheduled neurologist visits for MS-related and non-MS-related visits.|Baseline 301, Weeks 24, 48, 72, 96, 120 and 144 in 301|301-303 ITT Population consisted of all participants who completed Study 301 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.|||site visits|||Number
2635925|NCT01797965|Secondary|Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period|Heath resource utilization was assessed by the number of hospitalizations, emergency room visits, and unscheduled neurologist visits for MS-related and non-MS-related visits.|301-303: Baseline 303, Weeks 24, 48, 96, 144, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48, 96 in 303|ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.|||site visits|||Number
2635926|NCT01797965|Secondary|Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period|The participant rated their current heath state using the EQ VAS 20-centimeter horizontal line from 0 (worst imaginable health state) to 100 (best imaginable health state). A positive change from baseline indicates improvement.|301-303: Baseline 303, Weeks 12, 24, 48, 96, 120, 44, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48 and 96 in Study 303|ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.|||score on a scale||Standard Deviation|Mean
2635927|NCT01797965|Secondary|Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period|The EQ-5D is a self-administered questionnaire consisting of 5 domains pertaining to specific health state profile : mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The participants recorded their level of current health for each domain where: 1=no problems, 2=some problem and 3=severe problems. The health score is derived from the individual scores for each of the 5 domains transformed to a score of 0=worst health state to 1=perfect health state. A positive change from Baseline indicates improvement.|301-303: Baseline 303, Weeks 12, 24, 48, 96, 120, 144, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48 and 96 in Study 303|ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.|||score on a scale||Standard Deviation|Mean
2635928|NCT01797965|Secondary|Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period|The 29-item MSIS-29 is a disease specific participant-reported outcome measure that has been developed and validated to examine the physical (coordination and mobility) and psychological (mental) impact of MS from a participant's perspective; it measures 20 physical items and 9 psychological items. The results for each of the physical and psychological scores are transformed to a score of 0 to 100 (worse state of health). A negative change from Baseline indicates improvement.|Baseline 303, Weeks 12, 24, 48, 96, 120 and 144|301-303 ITT Population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected for participants from the 203 and 302 studies.|||score on a scale||Standard Deviation|Mean
2635929|NCT01797965|Secondary|Number of Participants Who Are Free From Disease Activity in the 205MS303 Treatment Period|Participants without clinical or radiological activity are defined as disease-free. Clinical activity includes assessment of relapses and of disease progression. Radiological activity includes assessments of Gd+ lesions and new or enlarging T2 lesions.|Up to 4.6 years in Study 303|301-303 ITT Population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. No data was collected for participants from the 203 and 302 studies.|||Participants|||Count of Participants
2635930|NCT01797965|Secondary|Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period|The EDSS measures the disability status of people with multiple sclerosis as assessed by the Study Neurologist based on 8 functional systems that ranges from 0=normal neurologic exam; to 5=ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to 10=death due to MS. Higher scores indicate more disability. A negative change from Baseline indicates improvement.|301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 260; 203-303 and 302-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 116 in Study 303|ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.|||score on a scale||Standard Deviation|Mean
2635931|NCT01797965|Secondary|Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period|"MSFC is a three-part, standardized, quantitative, assessment instrument consisting of (Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) and Paced Auditory Serial Addition Test (PASAT-3). 2 timed 25-foot walk scores are averaged. 4 trials of the Peg Test (2 for each hand) are converted to the reciprocals and averaged. The number correct of the PASAT-3 is used. The composite Z-score is calculated by: Z(25-foot walk) + Z (HPT) + Z(PASAT)/3. A positive change from baseline indicates improvement."|Baseline 301, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 in the 301 study, Baseline 303, Weeks 12, 24, 48 in the 303 study|301-303 ITT Population consisted of all participants who completed Study 301 and received at least one dose of DAC HYP in Study 303. Number analyzed: Number of participants with data available at given timepoint.|||z-score||Full Range|Median
2635977|NCT01797471|Secondary|Progression-Free Survival (PFS)|Rate of progression-free survival (PFS). PFS is defined as the length of time from date of treatment initiation until date of documented disease progression or death from any cause, with censoring of patients who are lost to follow-up.|Assessed up to 2 years|A minimum sample size of 10 study participants was required for the analysis of the outcome measure. Minimum enrollment was not met, therefore, the data were not analyzed.||||||
2636046|NCT01797029|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed, Influenza Virus Infection (All Strains)||Through 7 to 9 months post-vaccination|||||||
2635932|NCT01797965|Secondary|Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period|"MSFC is a three-part, standardized, quantitative, assessment instrument consisting of (Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) and Paced Auditory Serial Addition Test (PASAT-3). 2 timed 25-foot walk scores are averaged. 4 trials of the Peg Test (2 for each hand) are converted to the reciprocals and averaged. The number correct of the PASAT-3 is used. The composite Z-score is calculated by: Z(25-foot walk) + Z (HPT) + Z(PASAT)/3. A positive change from baseline indicates improvement."|Baseline 303, Weeks 12, 24 and 48 in Study 303|301-303 ITT Population consisted of all participants who completed Study 301 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected from participants from the 203 and 302 studies.|||z-score||Full Range|Median
2635933|NCT01797965|Secondary|Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period|Volume of T2 hyperintense Lesions was evaluated by MRI and was analyzed by a central MRI reader.|Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303; 203-303 and 302-303: Week 96|ITT Population included all participants who completed Study 301, 203 or 302 and received at least 1 dose of DAC HYP in Study 303. Number Analyzed is the number of participants with data available at the given timepoint.|||millimeters cubed (mm^3)||Standard Deviation|Mean
2635934|NCT01797965|Secondary|Percent Change in Brain Volume From 205MS301 Baseline|To assess brain atrophy, total brain volume was measured by MRI and was analyzed by a central MRI reader. A negative percent change from baseline indicates improvement.|Baseline 301, Weeks 48, 96, 144, 192, 240 in Study 303|301-303 ITT Population consisted of all participants who completed Study 303 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.|||percent change||Standard Deviation|Mean
2635935|NCT01797965|Secondary|Percent Change in Brain Volume From the 205MS303 Baseline|To assess brain atrophy, total brain volume was measured by MRI and was analyzed by a central MRI reader. A negative percent change from baseline indicates improvement.|Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303|301-303 ITT Population consisted of all participants who completed Study 303 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected for participants from the 203 and 302 studies.|||percent change||Standard Deviation|Mean
2635936|NCT01797965|Secondary|Number of Participants With New T1 Hypointense Lesions in the 205MS301 Treatment Period|T1 hypointense lesions were evaluated by MRI and were analyzed by a central MRI reader. The number of participants with New T1 Hyperintense Lesions relative to the 301 Baseline in the 301 Treatment Period is reported .|Baseline 301, Weeks 24, 96, 144 in Study 301|301-303 ITT Population consisted of all participants who completed Study 303 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.|||Participants|||Count of Participants
2635937|NCT01797965|Secondary|Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period|T1 hypointense lesions were evaluated by MRI and were analyzed by a central MRI reader. The number of participants with New T1 Hyperintense Lesions relative to the 303 Baseline in the 303 Treatment Period is reported.|Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303|301-303 ITT Population consisted of all participants who completed Study 303 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected from participants from the 203 and 302 studies.|||Participants|||Count of Participants
2635938|NCT01797965|Secondary|Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period|Gd+ lesions were evaluated by MRI and were analyzed by a central MRI reader.|Baseline 301, Weeks 24, 96 and 144|301-303 ITT Population consisted of all participants who completed Study 301 and received at least one dose of DAY HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.|||Participants|||Count of Participants
2635939|NCT01797965|Secondary|Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period|Gd+ lesions were evaluated by MRI and were analyzed by a central MRI reader.|301-303: Baseline 303, Weeks 48, 96, 144, 192, 240; 203-303 and 302-303: Week 96|ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAY HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.|||Participants|||Count of Participants
2635940|NCT01797965|Secondary|Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period|T2 Hyperintense Lesions were assessed by MRI and were analyzed by a central MRI reader. The number of participants with New or Newly Enlarging T2 Hyperintense Lesions relative to the 301 Baseline in the 301 Treatment Period is reported.|Baseline 301, Weeks 24, 96, 144 in Study 301|301-303 ITT population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. Number analyzed is the number of participants with data available at the given timepoint.|||Participants|||Count of Participants
2635941|NCT01797965|Secondary|Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period|T2 Hyperintense Lesions were assessed by magnetic resonance imaging (MRI) and were analyzed by a central MRI reader. The number of participants with New or Newly Enlarging T2 Hyperintense Lesions relative to the 303 Baseline in the 303 Treatment Period is reported.|Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303|301-303 ITT population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. No data was collected for participants from the 203 and 302 studies. Number analyzed is the number of participants with data available at the given timepoint.|||Participants|||Count of Participants
2635942|NCT01797965|Secondary|Number of Participants With Sustained Disability Progression in the 205MS301-303 Combined Study Period|Sustained disability progression is defined as at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from 303 baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from 303 baseline EDSS of 0, that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) =normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Higher scores indicate more disability.|Up to 5.6 years combining 303 with the initial Study 301|301-303 ITT Population consisted of all participants who completed Study 301 and had at least 1 dose of DAC HYP during Study 303.|||Participants|||Count of Participants
2635943|NCT01797965|Secondary|Number of Participants With Sustained Disability Progression in the 205MS303 Treatment Period|Sustained disability progression is defined as at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from 303 baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from 303 baseline EDSS of 0, that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) =normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Higher scores indicate more disability.|Up to 4.6 years in Study 303|ITT Population consisted of all participants who completed Study 301, 203 or 302 and had at least 1 dose of DAC HYP during Study 303.|||Participants|||Count of Participants
2635944|NCT01797965|Secondary|Number of Participants With Relapse in the 205MS301-303 Combined Study Period|Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist.|Up to 5.6 years combining 303 with the initial Study 301|301-303 ITT Population consisted of all participants who completed Study 301 and had at least 1 dose of DAC HYP during Study 303.|||Participants|||Count of Participants
2635945|NCT01797965|Secondary|Number of Participants With Relapse in the 205MS303 Treatment Period|Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist.|Up to 4.6 years in the 303 study|ITT Population consisted of all participants who completed Study 301, 203 or 302 and had at least 1 dose of DAC HYP during Study 303.|||Participants|||Count of Participants
2635946|NCT01797965|Secondary|ARR in the 205MS301-303 Combined Study Period and 205MS301 Treatment Period|Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. The unadjusted ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.25. Relapses that occurred after participants received alternative MS medications were excluded from the analyses. ARR was adjusted for relapse rate, IFN beta use, EDSS (<=2.5 vs >2.5) and age (<=35 vs >35) prior to start of study treatment in 301, calculated using the negative binomial model.|Up to 5.6 years combining 303 with the initial Study 301; Up to 1 year in the 301 study|301-303 ITT Population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303.|||relapses per year||95% Confidence Interval|Mean
2635947|NCT01797965|Secondary|Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period|Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. The unadjusted ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.25. Relapses that occurred after participants received alternative multiple sclerosis (MS) medications were excluded from the analyses. ARR was adjusted for relapse rate, IFN beta use, Expanded Disability Status Scale (EDSS) (<=2.5 vs >2.5) and age (<=35 vs >35) prior to start of study treatment in 205MS301, calculated using the negative binomial model.|Up to 4.6 years in the 303 study|Intent-to-treat (ITT) Population consisted of all participants who completed Study 301, 203 or 302 and received at least 1 dose of DAC HYP during Study 303.|||relapses per year||95% Confidence Interval|Mean
2635948|NCT01797965|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.|First dose of study drug in Study 303 to within 180 days of last dose (up to approximately 5.5 years)|Safety Population consisted of all participants who completed Study 301, 203 or 302 and had at least 1 dose of DAC HYP during Study 303.|||Participants|||Count of Participants
2635949|NCT01797835|Secondary|Number of Times Used Marijuana|"number of times used marijuana in the past 3 months; The 6-point frequency response scale (0= Never to 5= More than 20 times) was rescaled to a pseudo-continuous variable ranging from 0 to 20 using the mid-point of any range as the new value (e.g. 3-10 times was recoded as 6.5 times)."|Past 3 months||||score on a scale||Full Range|Mean
2635950|NCT01797835|Primary|Number of Times Used Alcohol|"in the past three months: Number of times used alcohol; The 6-point frequency response scale (0= Never to 5= More than 20 times) was rescaled to a pseudo-continuous variable ranging from 0 to 20 using the mid-point of any range as the new value (e.g. 3-10 times was recoded as 6.5 times)."|Past 3 months||||score on a scale||Full Range|Mean
2635951|NCT01797822|Primary|Changes in Corneal Fluorescein Staining|Subjects will be treated with preservative-free artificial tears for 2 weeks then exposed to a low humidity environment for 90 minutes, then treated with preservative-free dexamethasone 0.1% for 2 weeks and exposed to a low humidity environment again. The change in corneal fluorescein staining before and after the low humidity exposure was measured after each treatment. Fluorescein staining was graded using the CCLR scale (0-100) in 5 zones on the cornea for a maximum score of 500 (range 0-500). A lower change in staining indicates less severe disease in response to the low humidity stress. Negative number indicates staining after exposure was lower than pre.|Two weeks after treatment and exposure to a low humidity environment|difference (change) in fluorescein staining pre- and post-exposure to low humidity stress|||units on a scale||Standard Deviation|Mean
2635952|NCT01797783|Secondary|Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses|Visual Acuity was tested while reading charts at a distance of 40 cm from the participant with both eyes together. The Snellen fraction 20/20 represents 'normal' near vision. A larger denominator indicates a lower visual acuity.|Up to Day 30|This reporting group includes all randomized and dispensed participants who completed the study.|||participants|||Number
2635953|NCT01797783|Secondary|Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses|Visual Acuity was tested while reading a chart at 20-foot equivalent distance from the participant with both eyes together. The Snellen fraction compares the participant's result to the result expected from the 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity.|Up to Day 30|This analysis population includes all randomized and dispensed participants who completed the study.|||participants|||Number
2635954|NCT01797783|Primary|Subjective Overall Vision|"The participant was instructed to, Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision. The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent)."|Up to Day 30|"This analysis population includes all randomized and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of participants with non-missing values at the specific time point for each arm.~group,"|||Units on a scale||Standard Deviation|Mean
2635955|NCT01797731|Secondary|Time Required to Utilize System|The amount of time required to utilize conventional, tibial extramedullary alignment guides versus the KneeAlignTM system, which will be recorded intraoperatively.|Minutes during surgery ( Estimated time per surgery 1 hour)||||seconds||Standard Deviation|Mean
2635956|NCT01797731|Primary|Postoperative Tibial Component Alignment|The primary outcome will be the number of patients (percentage of patients) that met a predetermined criteria for Alignment as defined by within 2° of perpendicular to the tibial mechanical axis or 2° of a 3° posterior slope, postoperative tibial component alignment (mechanical varus/valgus, and posterior slope) as measured on postoperative standing anteroposterior hip-to-ankle radiographs, and standing, lateral knee-to-ankle radiographs, respectively.|6 weeks after surgery||||percentage of participants|||Number
2635957|NCT01797705|Primary|% Agreement Between Reviewer and Machine Pressure Settings During Sleep Study|"The primary objective for the study was demonstrating effectiveness of therapy provided by the DeVilbiss AutoAdjust device as reported by the expert human reviewer. The primary endpoint was that expert human reviewer should agree with pressure changes made by the machine during each 20-minute epoch at least 80% of the time. Expert human reviewer reviewed each study and made a determination at 20-minute time points, in context of REM/NON-REM sleep and supine/non-supine positions, marking the machine pressure response with an agree or disagree. Pressure changes might show no change, increase or decrease during the 20-minute epoch."|1 night|Subjects completing the study with evaluable results|||percentage of agreement||95% Confidence Interval|Number
2635958|NCT01797575|Secondary|Oxidative Stress as Indicated by Serum Thiobarbituric Acid Reactive Substances (TBARS) Levels||baseline, week 8, week 16|Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.||||||
2635959|NCT01797575|Secondary|Oxidative Stress as Indicated by Catalase Activity||baseline, week 8, week 16|Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.||||||
2635960|NCT01797575|Secondary|Oxidative Stress as Indicated by Superoxide Dismutase Activity||baseline, week 8, week 16|Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.||||||
2635961|NCT01797575|Secondary|Inflammation as Indicated by Tumor Necrosis Factor (TNF)-Alpha Levels||baseline, week 8, week 16|Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.||||||
2635962|NCT01797575|Secondary|Inflammation as Indicated by Soluble Interleukin-2 (IL-2) Receptor Levels||baseline, week 8, week 16|Data was not collected for this outcome measure. Blood samples were collected from participants, but tests for this particular outcome measure were not completed.||||||
2635963|NCT01797575|Secondary|Inflammation as Indicated by Interleukin 6 (IL-6) Levels|Interleukin 6 (IL-6) is an interleukin that acts as a pro-inflammatory cytokine and an anti-inflammatory myokine. IL-6 is measured in picograms (pg) per milliliter (mL). Elevated interleukin-6 indicates potential immune system dysregulation and increased inflammation.|baseline, week 8, week 16|Row numbers differ from overall number analyzed either due to patient withdrawal from study prior to completion, or from failure to obtain a blood sample from patient during study. Overall number analyzed differs from overall number of baseline participants for the same reason.|||picograms per milliliter||Standard Deviation|Mean
2635964|NCT01797575|Secondary|Inflammation as Indicated by C-reactive Protein (CRP) Levels|C-reactive protein (CRP) levels are blood test markers of inflammation. Higher CRP corresponds with higher levels of inflammation. CRP is measured in milligrams per liter.|baseline, week 8, week 16|Row numbers differ from overall number analyzed either due to patient withdrawal from study prior to completion, or from failure to obtain a blood sample from patient during study. Overall number analyzed differs from overall number of baseline participants for the same reason.|||milligrams per liter||Standard Deviation|Mean
2635965|NCT01797575|Primary|Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS)|The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts. This 30% MADRS reduction was analyzed in addition to initial outcome measures of 50% MADRS reduction due to the smaller than expected study sample size.|Received drug for 8 weeks during week 9 to week 16 of the study|Patients who responded to treatment during week 0-8 were maintained on current treatment. Patients who did no respond were re-randomized for week 9-16.|||Participants|||Count of Participants
2636047|NCT01797029|Secondary|Safety Profile of LAIV: Protocol Defined Wheezing Illness||Through 7 to 9 months post-vaccination|||||||
2635966|NCT01797575|Primary|Number of Patients Demonstrating a > 30% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS)|The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts. This 30% MADRS reduction was analyzed in addition to initial outcome measures of 50% MADRS reduction due to the smaller than expected study sample size.|Received drug for 8 weeks during week 0 to week 8 of the study||||Participants|||Count of Participants
2635967|NCT01797575|Primary|Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS)|The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts.|Received drug for 8 weeks during week 9 to week 16 of the study|Patients who responded to treatment during week 0-8 were maintained on current treatment. Patients who did no respond were re-randomized for week 9-16.|||Participants|||Count of Participants
2635968|NCT01797575|Primary|Number of Patients Demonstrating a > 50% Decrease in Depression Scores on the Montgomery-Åsberg Depression Rating Scale (MADRS)|The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The questionnaire includes questions on the following symptoms: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts.|Received drug for 8 weeks during week 0 to week 8 of the study||||Participants|||Count of Participants
2635969|NCT01797536|Primary|Apparent Terminal Half-Life (t1/2) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the t1/2 of elbasvir.|Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.|||hr||Geometric Coefficient of Variation|Geometric Mean
2635970|NCT01797536|Primary|Time to Maximum Concentration (Tmax) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the maximum concentration (Cmax) of elbasvir. The time to reach Cmax (Tmax) was determined.|Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.|||hour (hr)||Full Range|Median
2635971|NCT01797536|Primary|Concentration at 24 Hours (C24) After Dosing Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24, to determine the concentration of elbasvir at Hour 24 was determined.|Hour 24|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.|||nM||95% Confidence Interval|Geometric Mean
2635972|NCT01797536|Primary|Maximum Concentration (Cmax) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the Cmax of Elbasvir.|Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, 24, 48, 96, 144, and 168|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.|||nM||95% Confidence Interval|Geometric Mean
2635973|NCT01797536|Primary|Area Under the Curve From 0 to 24 Hours (AUC0-24hr) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 to determine the AUC0-24hr of elbasvir.|Predose and Hours 0.5, 1, 2, 3, 4, , 6, 8, 12, 16, and 24|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.|||μM•hr||95% Confidence Interval|Geometric Mean
2635974|NCT01797536|Primary|Area Under the Curve From 0 to Infinity (AUC0-inf) of Elbasvir|Blood samples were collected at predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168 to determine the AUC0-inf of elbasvir.|Predose and Hours 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 144, and 168|Participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment and had available data for the endpoint. Moderate arm summary excludes data for 3 participants incorrectly re-enrolled and dosed in moderate arm after completing dosing and follow-up in the mild insufficiency arm.|||μM•hr||95% Confidence Interval|Geometric Mean
2635975|NCT01797484|Primary|Left Ventricular Global Strain Rate|Relativ acceleration or deceleration (1/s) of left ventricular myocardial sections compared to direct opposite section. The more positive the value, the more simultaneously the movements, the more hemodynamically better.|42 days after first dose of Ranolazine|Secondary Outcome Measure data was not collected. Initially planned secondary outcome (e.g. cardiac events) was found to interfere with monitoring drug safety|||percentage of change||Standard Deviation|Mean
2636048|NCT01797029|Secondary|Safety Profile of LAIV: Serious Adverse Events||Through 7 to 9 months post-vaccination|||||||
2635978|NCT01797471|Secondary|Rate of Loco-regional Failure in Study Participants|Rate of loco-regional failure in study participants. Loco-regional failure is defined as any evidence of disease progression within the primary primary tumor or regional lymph nodes, detected by any method.|Assessed up to 2 years|A minimum sample size of 10 study participants was required for the analysis of the outcome measure. Minimum enrollment was not met, therefore, the data were not analyzed.||||||
2635979|NCT01797471|Secondary|Rate of Study Participants Achieving Complete or Partial Response Via PET Response Criteria|"Rate of subjects achieving complete response (CR) or partial response (PR) as detected by positron emission tomography (PET) Scan:~CR is defined as no residual focal fluorodeoxyglucose (FDG) uptake or decrease in average FDG uptake by more than 80% in all tumor manifestations.~PR is defined as standardized uptake value (SUV) decrease by 0 - 80%."|Assessed up to 2 years|A minimum sample size of 10 study participants was required for the analysis of the outcome measure. Minimum enrollment was not met, therefore, the data were not analyzed.||||||
2635980|NCT01797471|Secondary|Rate of Study Participants Achieving Complete or Partial Response Via CT RECIST Response Criteria|"Number of subjects achieving complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria on CT Scan:~CR: Complete disappearance of all disease. No new lesions. No disease related symptoms. Normalization of markers and other abnormal lab values. All disease must be assessed using the same technique as baseline.~PR: Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions."|Assessed up to 2 years|A minimum sample size of 10 study participants was required for the analysis of the outcome. Minimum enrollment was not met, therefore, the data were not analyzed.||||||
2635981|NCT01797471|Primary|Rate of Treatment-related Toxicity in Study Participants|Rate of treatment-related toxicity (serious adverse events, adverse events, etc.) in study participants. Toxicity will be assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The two toxicities that will be monitored as primary endpoints are esophagitis and pneumonitis.|Up to 12 months|Study participants experiencing treatment-related esophagitis or pneumonitis.|||Participants|||Count of Participants
2635982|NCT01797458|Other Pre-specified|Number of Participants Reporting Pain Experience During Treatment|Child's perception of pain intensity during treatment was assessed using the Visual Analogue Scale of Faces. It is a five-point scale, which includes five faces of children representing from very light to very intense pain. Participants were asked to select the face that represents how he/she felt during the procedure.|Baseline assessment||||Participants|||Count of Participants
2635983|NCT01797458|Other Pre-specified|Number of Participants With Negative and Positive Behavior During Treatment|Behaviour of children during treatment was assessed using the Frankl Behavior Rating Scale. It is a four-point scale, which ranges from definitely negative behaviour, when the child refuses the treatment to definitely positive behaviour, when the participant is completely cooperative.|Baseline assessment||||Participants|||Count of Participants
2635984|NCT01797458|Other Pre-specified|Oral Health Status|Child`s oral health status as assessed by the gingival status and bacterial plaque index judged clinically after 1 and 2 years|1 and 2 years|||||||
2635985|NCT01797458|Secondary|Number of Children Experiencing Irreversible Pulpitis, Dental Abscess, or Extraction|Number of children experiencing irreversible pulpitis, dental abscess, or extraction judged clinically after 2 years|2 years||||Participants|||Count of Participants
2635986|NCT01797458|Primary|Failure Rate of the Three Treatment Arms Judged Clinically|Failure rate of the three treatment arms judged clinically after 2 years such as clear caries progression, secondary caries, loss of restoration, reversible pulpitis treated without requiring pulpotomy|2 years||||Teeth|||Number
2635987|NCT01797445|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96|Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||percent change||Inter-Quartile Range|Median
2635988|NCT01797445|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48|Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||percent change||Inter-Quartile Range|Median
2635989|NCT01797445|Secondary|Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||percent change||Inter-Quartile Range|Median
2635990|NCT01797445|Secondary|Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||percent change||Inter-Quartile Range|Median
2635991|NCT01797445|Secondary|Percentage of Participants With Treatment-emergent Proteinuria Through Week 96|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.|Baseline to Week 96|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.|||percentage of participants|||Number
2635992|NCT01797445|Secondary|Percentage of Participants With Treatment-emergent Proteinuria Through Week 48|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.|Baseline to Week 48|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.|||percentage of participants|||Number
2635993|NCT01797445|Secondary|Change From Baseline in Serum Creatinine at Week 96||Baseline; Week 96|Participants in the Safety Analysis Set were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||mg/dL||Standard Deviation|Mean
2635994|NCT01797445|Secondary|Change From Baseline in Serum Creatinine at Week 48||Baseline; Week 48|The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||mg/dL||Standard Deviation|Mean
2636049|NCT01797029|Secondary|Safety Profile of LAIV: Immediate Reactions||30 minutes post-vaccination||||participants|||Number
2635995|NCT01797445|Secondary|Percent Change From Baseline in Spine BMD at Week 96|Spine BMD was assessed by DXA scan.|Baseline; Week 96|Participants in the Spine DXA Analysis Set were analyzed. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||percent change||Standard Deviation|Mean
2635996|NCT01797445|Secondary|Percent Change From Baseline in Spine BMD at Week 48|Spine BMD was assessed by DXA scan.|Baseline; Week 48|The Spine DXA Analysis Set included all participants who were randomized and received at least 1 dose of study drug, and have nonmissing baseline spine BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||percent change||Standard Deviation|Mean
2635997|NCT01797445|Secondary|Percent Change From Baseline in Hip BMD at Week 96|Hip BMD was assessed by DXA scan.|Baseline; Week 96|Participants in the Hip DXA Analysis Set were analyzed. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||percent change||Standard Deviation|Mean
2635998|NCT01797445|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline; Week 48|The Hip DXA Analysis Set included all participants who were randomized and received at least 1 dose of study drug, and have nonmissing baseline hip BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||percent change||Standard Deviation|Mean
2635999|NCT01797445|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with available data were analyzed.|||cells/µL||Standard Deviation|Mean
2636000|NCT01797445|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed.|||cells/µL||Standard Deviation|Mean
2636001|NCT01797445|Secondary|Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48 and 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Weeks 48 and 96|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2636002|NCT01797445|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2636003|NCT01797445|Primary|Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2636004|NCT01797380|Primary|Reduction in Depressive Symptoms|Depressive symptoms were assessed by questionaire at baseline and finally at the end of the study at 9 weeks.|9 weeks.|Terminated due to lack of recruitment. Five subjects were consented for the trial, but were not able to complete study or generate analyzable data.||||||
2636005|NCT01797328|Primary|Brown Adipose Tissue, Absolute Volume|Sub-clavicular brown adipose tissue volume by magnetic resonance imaging (liters)|Baseline and 6 week|Brown adipose tissue volume (liters)|||liters||Standard Deviation|Mean
2636006|NCT01797263|Secondary|Arthritis Self-efficacy Scale|This scale has been well-validated to assess self-efficacy or confidence in a person's ability to complete a task. Min: 0, Max: 60. Higher score represents improvement.|3 Month|A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.|||units on a scale||Standard Deviation|Mean
2636007|NCT01797263|Secondary|Pain Catastrophizing Scale|This 13-item scale assesses pain catastrophizing which has been found to be a predictor of poor treatment response. Min: 0. Max: 52. Higher Score = Worse Outcome.|3 Month|A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.|||units on a scale||Standard Deviation|Mean
2636008|NCT01797263|Secondary|MOS Sleep Scale - Problems Index|This scale assesses different aspects of sleep quality and provides an overall index with higher scores representing more severe sleep problems. Min:0, Max: 100. Higher Score = Worse Outcome.|3 Month|A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.|||units on a scale||Standard Deviation|Mean
2636009|NCT01797263|Secondary|Multi-dimensional Fatigue Inventory|This scale assesses overall fatigue and has been well-validated and used in other fibromyalgia trials. Min:0, Max: 100. Higher Score = Worse Outcome.|3 Month|A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.|||units on a scale||Standard Deviation|Mean
2636010|NCT01797263|Secondary|SF-12 Mental Score (Health-related Quality of Life)|The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome.|3 Month|A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.|||units on a scale||Standard Deviation|Mean
2636011|NCT01797263|Secondary|SF-12 Physical Score (Health-related Quality of Life)|The SF-12 is a well-validate measure of health-related quality of life; providing a physical and mental health component summary score. Min:0, Max: 100. Higher Score = Worse Outcome.|3 Month|A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.|||units on a scale||Standard Deviation|Mean
2636050|NCT01797029|Secondary|Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions||Through one week post-vaccination|||||||
2636013|NCT01797263|Secondary|GAD-7 Anxiety Scale|This 7-item scale represent a measure of anxiety symptom severity and provides a score from 0 to 21 with higher scores representing more severe anxiety|3 Month|A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.|||units on a scale||Standard Deviation|Mean
2636014|NCT01797263|Secondary|PHQ-9 for Depression|will be used to assess depression severity. Several studies have validated the PHQ-9 as a diagnostic measure with excellent psychometric properties. Internal consistency has consistently been shown to be high (Cronbach's alpha > 0.80) and test-retest assessment showed the PHQ-9 to be a responsive and reliable measure of depression treatment outcomes. Min:0, Max: 27. Higher Score = Worse Outcome.|3 Month|A small number of participants opted to not complete this Outcome measure, causing a discrepancy between this module and the flow module.|||units on a scale||Standard Deviation|Mean
2636015|NCT01797263|Secondary|Brief Pain Inventory (BPI) Severity Subscale|is an 11-item, multidimensional pain measurement tool with demonstrated reliability in patients with arthritis as well as other pain conditions. The BPI rates the intensity of pain as well as the interference of pain with mood, physical activity, work, social activity, relations with others, sleep, and enjoyment of life.Min:0, Max: 40. Higher Score = Worse Outcome.|3 month||||units on a scale||Standard Deviation|Mean
2636016|NCT01797263|Secondary|Fibromyalgia Impact Questionnaire Revised Symptoms Subscale|This subscale of the FIQr provides an overall fibromyalgia symptom score. Min:0, Max: 100. Higher Score = Worse Outcome|3 Month||||units on a scale||Standard Deviation|Mean
2636017|NCT01797263|Secondary|Fibromyalgia Impact Questionnaire-Revised Impact Subscale|This is a subscale of the FIQr and measures the overall impact of fibromyalgia symptoms. Min:0, Max: 100. Higher Score = Worse Outcome.|3 Month||||units on a scale||Standard Deviation|Mean
2636018|NCT01797263|Secondary|Fibromyalgia Impact Questionnaire-Revised Difficulty Subscale|This represents a subscale of the FIQr and measures patient perceived difficulty related to fibromyalgia. Min:0, Max: 20. Higher Score = Worse Outcome.|3 Month||||units on a scale||Standard Deviation|Mean
2636019|NCT01797263|Primary|Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score|This measure will be assessed at Baseline, 1, 3, 6 and 9 months. The 3 month is the primary end point and the 6 and 9 month assessments are for sustained effect. Min:0, Max: 90. Higher Score = Worse Outcome.|3 month||||units on a scale||Standard Deviation|Mean
2636020|NCT01797185|Primary|Number of Subjects With Adverse Events||52 weeks|Safety population: Subject who received at least one dose of study treatment|||Count of participants|||Number
2636021|NCT01797120|Secondary|Overall Survival|Overall survival will be characterized using Kaplan-Meier plots and other descriptive metrics.|Every 3 months until progression or up to 3 years|all randomized patients|||months||95% Confidence Interval|Median
2636022|NCT01797120|Secondary|Objective Response Rate|Objective response rate is defined as number of patients with complete or partial response (by Physical Exam, CT or MRI) divided by number of patients randomized in each arm|Every 3 months until progression or up to 3 years|all randomized patients|||proportion of patients||95% Confidence Interval|Number
2636023|NCT01797120|Secondary|Clinical Benefit Rate|Clinical benefit rate is defined as number of patients with objective response (complete response or partial response) or stable disease for at least 24 weeks divided by number of patients randomized in each arm. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease; Complete Response (CR) is defined as disappearance of all target lesions.|Every 3 months until progression or up to 3 years|all randomized patients|||proportion of patients||95% Confidence Interval|Number
2636024|NCT01797120|Primary|Progression-free Survival|Progression-free survival documented by Physical Exam, CT Scan or MRI in post-menopausal patients with hormone-receptor positive metastatic breast cancer that is resistant to aromatase inhibitor therapy treated with fulvestrant and everolimus compared to fulvestrant alone from randomization to documented disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Every 3 months until progression or up to 3 years|all randomized patients|||months||95% Confidence Interval|Median
2636025|NCT01797094|Secondary|Percentage of Participants Mostly or Very Satisfied With Their Crow's Feet Lines on the Facial Line Satisfaction Questionnaire|Participants assessed their overall satisfaction at the present moment using a 5-point scale where -2=very dissatisfied, -1=mostly dissatisfied, 0=neither dissatisfied nor satisfied, 1=mostly satisfied and 2=very satisfied. The percentage of participants mostly or very satisfied is reported.|Day 30|Intent-to-treat population included all enrolled participants.|||percentage of participants|||Number
2636026|NCT01797094|Secondary|Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline|"Participants were considered to judge themselves as looking younger if the category change was from look my current age at Baseline to look younger at Day 30 or from look older at Baseline to look my current age/younger at Day 30."|Baseline, Day 30|Intent-to-treat population included all enrolled participants. Only those participants who rated themselves as looking their current age or older at Baseline were included in the analyses.|||percentage of participants|||Number
2636027|NCT01797094|Secondary|Percentage of Participants With a ≥3-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 8 at Day 30|"The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much) FLO-11 responders were defined as the percentage of participants with a ≥3-point improvement from Baseline in FLO-11 Item 8: My facial lines make me look tired score."|Baseline, Day 30|Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 8 scores ≥ 3 at Baseline were included in the analysis.|||percentage of participants|||Number
2636051|NCT01797029|Primary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains).||Through 7 to 9 months post-vaccination||||percentage of participants|||Number
2636028|NCT01797094|Secondary|Percentage of Participants With a ≥2-point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 5 at Day 30|"The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored using an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Score Item 5: My facial lines make me look less attractive than I want to look score."|Baseline, Day 30|Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 5 scores ≥2 at Baseline are included in the analysis.|||percentage of participants|||Number
2636029|NCT01797094|Secondary|Percentage of Participants With a ≥2-Point Improvement From Baseline for Facial Line Outcomes Questionnaire (FLO-11) Item 2 at Day 30|"The FLO-11 questionnaire is comprised of 11 items that assess the subject's perceptions about specific aspects of their facial lines for the previous 7 days. Each question was scored on an 11-point scale (0=not at all, 5=somewhat, 10=very much). FLO-11 responders were defined as the percentage of participants with a ≥2-point improvement from Baseline in FLO-11 Item 2 : When I look in the mirror, my facial lines make me look older than I want to look score."|Baseline, Day 30|Intent-to-treat population included all enrolled participants. Only participants with FLO-11 Item 2 scores ≥2 at Baseline are included in the analysis.|||percentage of participants|||Number
2636030|NCT01797094|Secondary|Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow's Feet Lines (SGA-CFL)|Participants rated the change in their Crow's Feet Lines using the SGA-CFL 7-point scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse at Day 30. The percentage of participants who reported Much Improved or Very Much Improved at Day 30 is reported.|Day 30|Intent-to-treat population included all enrolled participants.|||percentage of participants|||Number
2636031|NCT01797094|Primary|Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)|The Investigator assessed the severity of the participant's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Intent-to-treat population included all enrolled participants.|||percentage of participants|||Number
2636032|NCT01797081|Secondary|Percentage of Participants Who Rate Themselves in a Younger Self-Perception of Age Category Than at Baseline|"Participants were considered to judge themselves as looking younger if the category change was from look my current age at Baseline to look younger at Day 30 or from look older at Baseline to look my current age/younger at Day 30."|Day 30|Intent-to-treat population included all enrolled participants. Only those participants who rated themselves as looking their current age or older at Baseline were included in the analyses.|||percentage of participants|||Number
2636033|NCT01797081|Secondary|Percentage of Participants Much Improved or Very Much Improved in the Subject's Assessment of Appearance of CFL as Measured by the Global Assessment of Change in Crow's Feet Lines|Participants rated the change in their Crow's Feet Lines using the Subject's Global Assessment of Change in Crow's Feet Lines (SGA-CFL) 7-point scale where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse or 7=very much worse. The percentage of participants who reported Much Improved or Very Much Improved at Day 30 is reported.|Day 30|Intent-to-treat population included all enrolled participants.|||percentage of participants|||Number
2636034|NCT01797081|Secondary|Percentage of Participants Achieving a ≥1-Grade Improvement From Baseline on the Investigator's Assessment of the Severity of CFL at Rest Using the FWS-A|The Investigator assessed the severity of the participant's Crow's Feet Lines at rest using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1-grade improvement from Baseline at Day 30 is reported.|Day 30|Participants from the Intent-to-treat population, all enrolled participants, with data available for analysis.|||percentage of participants|||Number
2636035|NCT01797081|Primary|Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale-Asian (FWS-A)|The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.|Day 30|Intent-to-treat population included all enrolled participants.|||percentage of participants|||Number
2636036|NCT01797029|Other Pre-specified|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (All Strains) Among Children||From approx. 6 months to approximately 19 months post-vaccination|||||||
2636037|NCT01797029|Other Pre-specified|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains) Among Children||From approx. 6 months to approximately 19 months post-vaccination|||||||
2636038|NCT01797029|Other Pre-specified|Percentage of Participants With Moderate to Severe, Laboratory-confirmed Influenza Virus Infection Among Children||Through 16 to 19 months post-vaccination|||||||
2636039|NCT01797029|Other Pre-specified|Percentage of Participants With Moderate to Severe, Laboratory-confirmed Influenza Virus Infection Among Children||Through 7 to 9 months post-vaccination|||||||
2636040|NCT01797029|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains).||Through 16 to 19 months post-vaccination|||||||
2636041|NCT01797029|Secondary|Percentage of Participants With Symptomatic, Laboratory-confirmed, Influenza Virus Infection (All Strains)||Through 16 to 19 months post-vaccination|||||||
2636042|NCT01797029|Secondary|Safety Profile of LAIV: Protocol Defined Wheezing Illness||Through 16 to 19 months post-vaccination|||||||
2636043|NCT01797029|Secondary|Safety Profile of LAIV: Serious Adverse Events||Through 16 to 19 months post-vaccination|||||||
2636044|NCT01797029|Secondary|The Viral Etiologies of Acute Respiratory and Febrile Illness||Through 16 to 19 months post-vaccination|||||||
2636045|NCT01797029|Secondary|The Clinical Characteristics of Influenza, Including Influenza Co-infections With Other Bacterial and Viral Respiratory Pathogens||Through 16 to 19 months post-vaccination|||||||
2636052|NCT01796977|Secondary|To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy|"Patient and Observer Scar Assessment Scale - range = 1 - 10. 1 is best condition (normal skin) and 10 is worst condition (worst scar imaginable). The scale is used to assess each of six different wound characteristics, including vascularity, pigmentation, thickness, relief, pliability, and surface area. The means of these combined scores and their respective standard deviations are reported for each study group. The range of the final evaluation score, based on the collective evaluation of each of the six wound characteristics is 6 (if each of the six scores equals 1) to 60 (if each of the six scores equals 10)."|30 days post nipple-sparing mastectomy|Each participant acted as her own control - one breast received OxyGenesys, while the other breast received the standard dressing. Two patients in the OxyGenesys study arm, and one patient in the Control study arm did not provide follow-up data.|||units on a scale||Full Range|Mean
2636053|NCT01796977|Secondary|To Assess Pain Using the Numerical Rating Scale|"Numerical Rating Scale (NRS) - range = 0 - 10. 0 corresponds to no pain and 10 indicates worst pain imaginable. The means of these scores and their respective standard deviations are reported for each study group."|30 days|There is just one NRS value calculated for the indicated time-frame, and thus a comparison between study groups with respect to this outcome was not made. The single NRS value at 30 days is reported here. One patient did not provide follow-up data at this time-point, and thus the total number of participants is 26 instead of 27 for this outcome.|||units on a scale||Standard Deviation|Mean
2636054|NCT01796977|Secondary|To Evaluate Scar Formation 30 Days Post Nipple-sparing Mastectomy|"Patient and Observer Scar Assessment Scale - range = 1 - 10. 1 is best condition (normal skin) and 10 is worst condition (worst scar imaginable). The scale is used to assess each of six different wound characteristics, including vascularity, pigmentation, thickness, relief, pliability, and surface area. The means of these combined scores and their respective standard deviations are reported for each study group. The range of the final evaluation score, based on the collective evaluation of each of the six wound characteristics is 6 (if each of the six scores equals 1) to 60 (if each of the six scores equals 10)."|30 days post nipple-sparing mastectomy|Each participant acted as her own control - one breast received OxyGenesys, while the other breast received the standard dressing. Two patients in the OxyGenesys study arm, and one patient in the Control study arm did not provide follow-up data.|||units on a scale||Standard Deviation|Mean
2636055|NCT01796977|Primary|Evaluate the Effects of OxyGenesys Dissolved Oxygen Dressing in Wound Complication Rates of the Nipple Areolar Complex Post Nipple-sparing Mastectomy|Wound Complication Rate|30 days|Each participant acted as her own control - one breast of each participant received the OxyGenesys Dressing, the other breast received the standard dressing.|||breasts|Participants||Number
2636056|NCT01796964|Secondary|Central Subfield Thickness (CSFT) Change From Baseline by Visit|CSFT (average thickness in the central subfield centered at the fovea) as measured using Spectral-Domain Optical Coherence Tomography (SD-OCT). Reduction in CSFT measurement from baseline indicates improvement. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.|||microns||Standard Deviation|Mean
2636057|NCT01796964|Secondary|Two-Months BCVA Changes (No. of Letters) Following No Treatment for 1 Month in ESBA Treatment Group|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. This outcome measure was pre-specified for ESBA1008 arm only. One eye (study eye) contributed to the analysis.|Week 36, Week 44, Week 48, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.|||letters||Standard Deviation|Mean
2636058|NCT01796964|Secondary|One-Month BCVA Changes (No. of Letters) Following Treatment by Visit|The purpose of this outcome measure was to assess the potential treatment needs present at these treatment visits. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.|||letters||Standard Deviation|Mean
2636059|NCT01796964|Secondary|One-Month BCVA Changes (No. of Letters) Following No Treatment for 1-Month|The purpose of this outcome measure was to assess the stability of BCVA during the second month of 8-week/12-week treatment cycles and specifically to identify potential under treatment. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.|||letters||Standard Deviation|Mean
2636073|NCT01796860|Secondary|Number of Participants With Change in Muscle Activity With Surface Electromyography (EMG) of Key Lower Extremity Muscles From Baseline to Final Testing|Surface electromyography will be done on key muscles in the lower extremity (quadriceps, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in muscle activity would be things like large changes in amplitude of muscle firing or changes in the timing of muscle firing, for example. These would indicate changes in strength or perhaps motor learning as a result of wearing the ankle foot orthosis.|Surface EMG will be done at the time of enrollment and week 13.||||participants|||Number
2639606|NCT01763866|Secondary|Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2636060|NCT01796964|Secondary|Average BCVA Change From Week 12 (No. of Letters) Over the Periods of Week 16 to Week 24, Week 16 Week 40, and Week 16 to Week 56|The purpose of this outcome measure was to assess the average maintenance level of BCVA following the 3 loading treatments (ie, after Week 12). BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. These changes were computed as the average of the changes from Week 12 to each monthly study visit corresponding to each period. One eye (study eye) contributed to the analysis.|Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.|||letters||Standard Deviation|Mean
2636061|NCT01796964|Secondary|Average BCVA Change From Baseline (No. of Letters) Over the Periods of Week 4 to Week 16, Week 4 to Week 24, Week 4 to Week 40, and Week 4 to Week 56|The purpose of this outcome measure was to assess the integrated effect of the treatment for different study periods and to provide more robust estimate of the absolute treatment effects. BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. These changes were computed as the average of the changes from baseline to each monthly study visit corresponding to each period. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.|||letters||Standard Deviation|Mean
2636062|NCT01796964|Secondary|BCVA Change From Baseline (No. of Letters) by Visit|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 4, Week 8, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48, Week 52, Week 56|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.|||letters||Standard Deviation|Mean
2636063|NCT01796964|Secondary|BCVA Change From Baseline (No. of Letters) to Week 16|BCVA (with spectacles or other visual corrective devices) using ETDRS testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 16|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.|||letters||Standard Deviation|Mean
2636064|NCT01796964|Primary|Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12|This outcome measure was used to compare the ESBA1008 and EYLEA groups in regards to fluctuations in treatment effect during the maintenance phase with 8-week treatment cycles (ie, to evaluate treatment effect stability during the maintenance phase). BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis.|Baseline (Day 0), Week 12|This analysis population includes all subjects who were randomized, received at least 1 treatment, had a baseline value, and had at least 1 postbaseline measurement of the primary efficacy variable, BCVA. Subjects were analyzed according to the actual treatment received with LOCF imputation of missing values.|||letters||Standard Deviation|Mean
2636065|NCT01796912|Secondary|Changes in Markers of Thrombogenesis|Thrombogenesis, Reduce value is better to the patients|3 months||||seconds||Inter-Quartile Range|Median
2636066|NCT01796912|Secondary|Change in Exercise Capacity Determined by Six Minute Walk Test|Six minute walk test, patient can walk longer distance means improvements|3 months||||meter||Inter-Quartile Range|Median
2636067|NCT01796912|Secondary|Change in SF-36 Quality of Life Score|Quality of Life score following, 0-100 score, high score improve quality of life|3 months||||units on a scale||Inter-Quartile Range|Median
2636068|NCT01796912|Secondary|Change in Seattle Angina Questionnaire Score|SAQ—Angina stability, increase means improvement. 0-100 scale, Higher score means improvements|3 months||||units on a scale||95% Confidence Interval|Mean
2636069|NCT01796912|Secondary|Change in Endothelial Vascular Function|EndoPat LnRHI - natural logarithm of reactive hyperaemia index. Increase - better outcome|Within 7 days before and after 3 months of weekly lipoprotein apheresis||||index||95% Confidence Interval|Mean
2636070|NCT01796912|Secondary|Change in Carotid Atherosclerosis/Plaque Burden Determined by Cardiovascular Magnetic Resonance Imaging|Changes from baseline to 3 months|3 months||||mm3||Inter-Quartile Range|Median
2636071|NCT01796912|Primary|Changes in Quantitative Myocardial Perfusion Measured by Stress/Rest Cardiovascular Magnetic Resonance Imaging|"Baseline compare to 3 month, changes presented Determine the impact of lipoprotein apheresis on quantitative myocardial perfusion measured by stress/rest cardiovascular magnetic resonance imaging.~Increase means better outcome"|3 months||||ratio||95% Confidence Interval|Mean
2636072|NCT01796860|Other Pre-specified|Change in Walking Endurance Using a 6-Minute Walk Test (6MWT) From Initial Testing to Final Testing|Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices as necessary.|6MWT will be done at the time of enrollment and week 13.||||meters||Standard Deviation|Mean
2636074|NCT01796860|Primary|Change in Step Length From Initial Testing to End of Study|Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.|Computerized gait analysis will be done at the time of enrollment and week 13.||||measure of length (cm)||Standard Deviation|Mean
2636075|NCT01796548|Secondary|King Health Questionnaire Score|King Health Questionnaire assesses the physical and psycho-social aspects of the disease state. It is a self-administered questionnaire containing 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep or energy, and severity of urinary symptoms). All domains were assessed in a range: 0-100, where 0=best outcome/response and 100=worst outcome or response. Lower scores indicates better outcome or response.|Baseline and Week 12|"ITT population. Here N signifies participants who were evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
2636076|NCT01796548|Secondary|Percentage of Participants With no Episodes of Urge-Urinary Incontinence|Percentage of participants with no episodes of urge urinary incontinence was reported. Urge urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency.|Baseline, Week 4 and Week 12|Data was not reported for this OM, as data was not analyzed because of change in the planned analysis of the study.||||||
2636077|NCT01796548|Secondary|Total Incontinence Episodes|Episodes of total urinary incontinence were reported. Urinary incontinence is the complaint of any involuntary leakage of urine.|Baseline, Week 4 and Week 12|"ITT population. Here n signifies participants who were evaluable for this measure at a particular time point. This study is early terminated and there were some missing data for total incontinence which lead to decrease value of total incontinence."|||Episodes||Standard Deviation|Mean
2636078|NCT01796548|Secondary|Urge Incontinence Episodes|Urge incontinence episodes were reported. Urge urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency with sudden feeling to go to toilet.|Baseline, Week 4 and Week 12|"ITT population. Here n signifies participants who were evaluable for this measure at a particular time point."|||Episodes||Standard Deviation|Mean
2636079|NCT01796548|Secondary|Reflex Volume|Reflex volume is the infused volume that induces the first detrusor contraction.|Baseline and Week 12|Data for this outcome measure is not reported because the data was not collected and included in Case Report Form (CRF).||||||
2636080|NCT01796548|Secondary|Post-Void Residual Urine Volume|Post-void residual urine volume is the amount of urine remaining in the bladder after void completion.|Baseline and Week 12|"ITT population. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants who were evaluable for this measure at a particular time point."|||Milliliter (ml)||Standard Error|Mean
2636081|NCT01796548|Secondary|Detrusor Leakpoint Pressure|Detrusor leakpoint pressure is the level of pressure at which leakage of urine through the urethra occurs as the bladder fills without an increase in abdominal pressure. This was a measure of both strength of the urethral sphincters and compliance of the detrusor muscle.|Baseline and Week 12|Data for this outcome measure is not reported because the data was not collected and included in Case Report Form (CRF).||||||
2636082|NCT01796548|Secondary|Maximal Cystometric Capacity (MCC)|MCC represents the maximum volume of urine the bladder holds.|Baseline and Week 12|ITT population.|||Milliliter (ml)||Standard Deviation|Mean
2636083|NCT01796548|Primary|Maximal Detrusor Pressure|Maximal detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. Detrusor pressure is the component of intravesical (in the bladder) pressure that is created by forces in the bladder wall (passive and active). It was estimated by subtracting abdominal pressure from intravesical pressure.|Week 12|The Intent-to treat (ITT) population included all randomly assigned participants who received at least 1 dose of study medication and fulfilled all eligibility criteria.|||Centimeter of water||Standard Deviation|Mean
2636084|NCT01796392|Secondary|6-minute Walk Distance|Difference between study arms in 'absolute and percentage change from baseline' for 6MWD at 1 year (value at 1 year minus value at baseline).|1 year|Intent-to-treat|||meters||Standard Deviation|Mean
2636085|NCT01796392|Secondary|St. George's Respiratory Questionnaire (SGRQ)|"Difference between study arms in 'absolute change from baseline' for SGRQ score at 1 year (value at 1 year minus value at baseline).~The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts:~Part I: Symptoms (frequency & severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease)~A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations."|1 year|Intent-to-treat|||score on a scale||Standard Deviation|Mean
2636086|NCT01796392|Secondary|FEV1 Post-bronchodilator Absolute Change|Difference between study arms in absolute change from baseline for post-bronchodilator FEV1 score at 1 year (value at 1 year minus value at baseline).|1 year|Intent-to-treat|||liters||Standard Deviation|Mean
2636087|NCT01796392|Primary|Forced Expiratory Volume in 1-second (FEV1)|The percentage of study participants in the Zephyr Valve EBV (Endobronchial Valves) treatment arm meeting the clinically significant threshold of >15% improved forced expiratory volume in one second (FEV1), obtained immediately following bronchodilator therapy, as compared to the percentage in the control arm at 1 year post-procedure.|1 year|Intent-to-Treat Population|||Participants|||Count of Participants
2636088|NCT01796301|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 12|Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).|Baseline and month 12|The primary efficacy analysis set with values at baseline and month 12|||percent change||Standard Error|Least Squares Mean
2636089|NCT01796301|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 6|Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).|Baseline and month 6|The primary efficacy analysis set with values at baseline and month 6|||percent change||Standard Error|Least Squares Mean
2636090|NCT01796301|Secondary|Percent Change From Baseline in Femoral Neck BMD at Month 12|Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).|Baseline and month 12|The primary efficacy analysis set with values at baseline and month 12|||percent change||Standard Error|Least Squares Mean
2636091|NCT01796301|Secondary|Percent Change From Baseline in Femoral Neck BMD at Month 6|Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).|Baseline and month 6|The primary efficacy analysis set with values at baseline and month 6|||percent change||Standard Error|Least Squares Mean
2673022|NCT01464931|Secondary|Number of Participants Who Developed Anti-denosumab Antibodies||From Day 1 (predose) to Day 113|Safety analysis set|||participants|||Number
2636092|NCT01796301|Secondary|Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 12|Total hip integral BMC was measured using quantitative computed tomography (QCT).|Baseline and month 12|The primary efficacy analysis set with values at baseline and month 12|||percent change||Standard Error|Least Squares Mean
2636093|NCT01796301|Secondary|Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6|Total hip integral BMC was measured using quantitative computed tomography (QCT).|Baseline and month 6|The primary efficacy analysis set with values at baseline and month 6|||percent change||Standard Error|Least Squares Mean
2636094|NCT01796301|Secondary|Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12|Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.|Baseline and month 12|The primary efficacy analysis set with values at baseline and month 12|||percent change||Standard Error|Least Squares Mean
2636095|NCT01796301|Secondary|Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6|Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.|Baseline and month 6|The primary efficacy analysis set with values at baseline and month 6|||percent change||Standard Error|Least Squares Mean
2636096|NCT01796301|Secondary|Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12|Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.|Baseline and month 12|The primary efficacy analysis set with values at baseline and month 12|||percent change||Standard Error|Least Squares Mean
2636097|NCT01796301|Secondary|Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6|Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.|Baseline and month 6|The primary efficacy analysis set with values at baseline and month 6|||percent change||Standard Error|Least Squares Mean
2636098|NCT01796301|Secondary|Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12|Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.|Baseline and month 12|The primary efficacy analysis set with values at baseline and month 12|||percent change||Standard Error|Least Squares Mean
2636099|NCT01796301|Secondary|Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6|Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.|Baseline and month 6|The primary efficacy analysis set with values at baseline and month 6|||percent change||Standard Error|Least Squares Mean
2636100|NCT01796301|Secondary|Percent Change From Baseline in Total Hip BMD at Month 12|Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).|Baseline and month 12|The primary efficacy analysis set with values at baseline and month 12|||percent change||Standard Error|Least Squares Mean
2636101|NCT01796301|Secondary|Percent Change From Baseline in Total Hip BMD at Month 6|Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).|Baseline and month 6|The primary efficacy analysis set with values at baseline and month 6|||percent change||Standard Error|Least Squares Mean
2636102|NCT01796301|Primary|Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD)|Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). Percent change from baseline through month 12 is the average of the treatment effect at months 6 and 12.|Baseline, month 6 and month 12|The primary efficacy analysis set includes randomized participants with a non-missing baseline and at least one post-baseline measurement.|||percent change||Standard Error|Least Squares Mean
2636103|NCT01796236|Other Pre-specified|Removal of Abutment|Count of subjects who had their abutment removed for reasons of health and safety, such as infection, inflammation or pain.|from surgery through to 36 months|The Safety Population includes all patients who had the surgical treatment.|||Participants|||Count of Participants
2636104|NCT01796236|Other Pre-specified|Loss of Implant|'Loss of Implant' refers to the loss of the implant for reasons including failure of implant to osseointegrate, or an implant that was loose form surgery. It does not include elected removal of the device.|from surgery through to 36 months|The Safety Population includes all patients who had the surgical treatment.|||Participants|||Count of Participants
2636105|NCT01796236|Other Pre-specified|Smoking Habits by Visit|"Nicotine use and smoking habits were recorded for patients.~Does not smoke~Less than 10 cigarettes/day (Low consumption)~Between 11 and 20 cigarettes/day (Medium consumption)~Between 21 and 40 cigarettes/day (High consumption)~More than 40 cigarettes/day (Very high consumption)~In Sweden a large proportion of adults use another form of tobacco, wet snuff. In Sweden the patients were asked if they used wet snuff."|baseline, Weeks 3, 12, Months 12, 24 and 36|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.|||Participants|||Count of Participants
2636106|NCT01796236|Other Pre-specified|Implant Stability (ISQ)|"ISQ is a well-established method to measure stability of osseointegrated implants and has been used for several years both for bone conduction implants and for dental implants. Measurements were performed using resonance frequency analysis at the abutment level. The highest and lowest ISQ value out of two perpendicular measurements obtained at each time point was recorded, ISQ High and ISQ Low. The ISQ values ranges from 1 to 100.~Overall, the length of test abutments (BA400) were longer than control abutments (BA300) and there is an inverse correlation between abutment length and stability. A direct comparison between the groups is not relevant.~Implant Stability Quotient (ISQ) was recorded at surgery as a baseline value and at visit 2-10."|Surgery, Day 10, Weeks 3, 6, 12, 24, Months 12, 24, 36|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.|||Implant Stability Quotient||Standard Deviation|Mean
2636107|NCT01796236|Other Pre-specified|Use of Sound Processor|Use of the sound processor can be seen as a reflection of patient satisfaction and treatment compliance. Patients were asked to record how many hours per week they used the sound processor after Baha loading at week 3.|Weeks 6, 12, 24, Months 12, 24, 36|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.|||Hours of use per week||Standard Deviation|Mean
2636161|NCT01795534|Primary|Time to Complete a 10 km Run|Time taken following consumption of beetroot shot or consumption of placebo shot|Period 1 (on day of 1st intervention) and period 2 (on day of 2nd intervention)||||Seconds||Standard Deviation|Mean
2636162|NCT01795495|Secondary|Post-operative Pain Scores|VAS pain score - 0 being no pain and 10 being worst pain.|Post-operatively to 24 hours||||units on a scale||Standard Deviation|Mean
2636108|NCT01796236|Other Pre-specified|Abbreviated Profile of Hearing Aid Benefit (APHAB)|"The Abbreviated Profile of Hearing Aid Benefit (APHAB) is a 24-item self-assessment, disability-based inventory that can be used to document the outcome of a hearing aid fitting, to compare several fittings, or to evaluate the same fitting over time. The subjects will complete the APHAB at pre-surgery, week 24, month 12 and 36.~Questions assess 'Ease of Communication', 'Background Noise', 'Reverberation', 'Aversiveness', and 'Global' in the aided and unaided situations. The aided situation was compared to the unaided situation at baseline (pre-surgery).~For each subscale, a score of 99 indicates that there is 'always' difficulty, and a score of 1 indicated that there is 'never' difficulty for that particular subscale."|Pre-surgery (baseline) to 24 weeks, 12 and 36 months|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.|||units on a scale||Standard Deviation|Mean
2636109|NCT01796236|Other Pre-specified|Health Utilies Index (HUI-III & HUI-II)|"Health Utilities Index (HUI) is a generic preference-based system for measuring comprehensive health status and health-related quality of life. Each index provides descriptive evidence on multiple dimensions of life quality.~HUI3: Comprehensive Health State, Vision, Hearing, Speech, Ambulation, Emotion, Cognition, Pain.~HUI2: Comprehensive Health State, Sensation, Mobility, Emotion, Cognition, Self Care, Pain.~Subjects completed HUI2/3 questionnaires at visit 1 (baseline), 7 (week 24), 8 (month 12) and 10 (month 36).~HUI score of 1 (maximum) describes a state of perfect health. HUI score of 0 describes a state of dead. A negative score of Comprehensive Health State describes a state worse than dead."|baseline (pre-surgery), week 24, months 12 and 36|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 through to visit 10 month 36.|||units on a scale||Standard Deviation|Mean
2636110|NCT01796236|Secondary|The Aesthetic Outcome of Surgery, the 'Patient and Observer Scar Assessment Scale' Consisted of Two Parts - a Patient and an Observer Scale, Week 12, Month 12 and 36.|"The patient scale contains six items (pain, itching, color, stiffness, thickness and irregularity) scored 1-10.~The observer scale contains six items (vascularity, pigmentation, thickness, relief, pliability and surface area) scored 1-10. Besides the 10-step scale, category boxes are available to score nominal parameters (e.g. type of color).~Both patient and observer should also score the overall opinion of the scar on the 1-10 scale.~For all above scales 1=normal skin, 10 worst scar imaginable.~Total score is the sum of the variables pain, itching, color, stiffness, thickness and irregularity (patient) and vascularity, pigmentation, thickness, relief, pliability and surface area (observer). The scale ranges from 6 to 60 (6 normal, 60 worst scar imaginable).~The pain not with in the scar variable ranges from 1 to 10. 1 being no pain at all and 10 being very much pain"|Week 12, Months 12 and 36|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.|||units on a scale||Standard Deviation|Mean
2636111|NCT01796236|Secondary|Visible Abutment Length by Visit for Patients With no Change of Abutment|"The investigator measured the visible abutment length at each visit. The length of BA400 test abutments initially placed were longer than BA300 control abutments places. A direct comparison between the groups is not relevant.~In some cases of increased soft tissue thickening or overgrowth, the abutment was exchanged for a longer abutment. The results presented here are only for patients with no change of abutment"|Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36|"The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 through to visit 10 Month 36.~This analysis is performed on subjects with no change of abutment."|||millimeters visible abutment length||Standard Deviation|Mean
2636112|NCT01796236|Secondary|Soft Tissue Thickening/Overgrowth|"The investigator rated the implant site in regards to soft tissue thickening/overgrowth at visits 3-10 according to the following scale:~0. No soft tissue thickening or overgrowth~Slight soft tissue thickening or overgrowth~Moderate soft tissue thickening or overgrowth. Local treatment and extra controls as indicated*~Marked/distinct soft tissue thickening or overgrowth. Revision surgery is indicated.*~Should also be reported on the AE page in the CRF"|Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.|||Participants|||Count of Participants
2636113|NCT01796236|Secondary|Pain by Visit - Categorical|"The subject rated the following questions 'has the scar been painful the past few weeks' and 'have you had any neuropathic pain during the past weeks' on the 1-10 scale were 1 = no, not at all and 10 = yes, very much.~Pain scale was categorised as 1='no pain', 2-3='mild pain', 4-6='moderate pain', 7-10='severe pain'."|Day 10, Weeks 3, 6, 12, 24, Months 12, 24 and 36|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and through until visit 10 Month 36.|||Participants|||Count of Participants
2636114|NCT01796236|Secondary|Pain - Maximum of Neuropathic and Scar Pain|The maximum neuropathic pain and the maximum scar pain experienced at any time throughout the study up until and including 36 months.|36 months|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.|||Participants|||Count of Participants
2636115|NCT01796236|Secondary|Pain - Maximum of Neuropathic and Scar Pain|The maximum neuropathic pain and the maximum scar pain experienced at any time throughout the study up until and including 12 months.|12 months|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.|||Participants|||Count of Participants
2636116|NCT01796236|Secondary|Pain in the Scar and Neuropathic Pain|The subject rated the following questions 'has the scar been painful the past few weeks' and 'have you had any neuropathic pain during the past weeks' on the 1-10 scale were 1 = no, not at all and 10 = yes, very much.|Day 10, Weeks 3, 6, 12, 24, Months 12 and 36|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and through until visit 10 Month 36.|||units on a scale||Standard Deviation|Mean
2636117|NCT01796236|Secondary|Max Numbness|"Subjects were asked if they experience any numbness around the abutment at each visit. The maximum numbness each subject experienced is summarized in this analysis. The following scale will be used:~No numbness~Numbness within 2 cm from the abutment~Numbness within and beyond 2 cm from the abutment"|12 & 36 months|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.|||Participants|||Count of Participants
2636118|NCT01796236|Secondary|Inflammation - Holgers Index by Visit|"Infection and inflammation were evaluated by the holgers index at visits 3-10 (Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36) and the following scale was used:~0. No irritation. Epidermal debris removed, if present~Slight redness. Local temporary treatment, if needed~Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated*~Reddish and moist; sometimes granulations tissue, revision surgery is indicated*~Removal of the abutment / implant necessary due to infection* R. Removal of implant for reasons not related to skin problems*"|Day 10, Weeks 3, 6, 12, 24, months 12, 24 and 36|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 through to month 36.|||Participants|||Count of Participants
2636119|NCT01796236|Secondary|Inflammation - Max of Holgers Index|"Max of Holgers index from day 10 to month 12, and to month 36 was recorded, using the Holgers scale from 0 - 4, where 0 = no inflammation and 4 = removal of abutment/implant necessary due to infection.~0. No irritation~Slight redness. Local temporary treatment, if needed~Red and slightly moist tissue. No granulation formation, local treatment and extra controls as indicated*~Reddish and moist; sometimes granulations tissue, revision surgery is indicated* R. Removal of the abutment / implant necessary due to infection* R Removal of implant for reasons not related to skin problems*"|From Day 10 to 12 Months, and to 36 Months|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.|||Participants|||Count of Participants
2636120|NCT01796236|Secondary|Wound Healing|A surgeon or a surgical nurse determined if the wound was healed or not healed.|Day 10, Weeks 3, 6, 12 and 24|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.|||participants|||Number
2636121|NCT01796236|Secondary|Surgery Time|Surgery time (minutes) was recorded|Day 0|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.|||minutes||Standard Deviation|Mean
2636122|NCT01796236|Primary|Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability|"Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events:~Holgers Index >=2 any time between 3 weeks to 1 year~Any overgrowth any time between 3 weeks to 1 year~Pain (scar/neuropathic) according to POSAS >=3 any time between 3 weeks to 1 year~Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject."|36 months|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.|||participants|||Number
2636123|NCT01796236|Primary|Number of Participants With Local Adverse Events as a Measure of Safety and Tolerability|"Combined endpoint of infection/inflammation, overgrowth, pain and numbness will be evaluated, as the sum of the following four events:~Holgers Index >=2 any time between 3 weeks to 1 year~Any overgrowth any time between 3 weeks to 1 year~Pain (scar/neuropathic) according to POSAS >=3 any time between 3 weeks to 1 year~Any numbness any time between 3 weeks to 1 year Each medical event is counted only once per subject resulting in a score of 0 to 4 for every subject."|12 months|The Intent-to-Treat population (ITT) consisted of all randomised patients with at least one follow-up measurement from visit 3 Day 10 and onward.|||participants|||Number
2636124|NCT01795937|Secondary|AUC0-tz of Rosuvastatin|"Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E_F.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods|PK set of the statins part and assigned to rosuvastatin (treatment sequence E_F).|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2636125|NCT01795937|Primary|Cmax of Rosuvastatin|"Maximum measured concentration of the analyte in plasma of rosuvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence E_F.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods|PK set of the statins part and assigned to rosuvastatin (treatment sequence E_F).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2636126|NCT01795937|Primary|AUC0-∞ of Rosuvastatin (Statins Part)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of rosuvastatin after single dose administration of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E_F.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods|PK set of the statins part and assigned to rosuvastatin (treatment sequence E_F).|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2636127|NCT01795937|Secondary|AUC0-tz of Atorvastatin|"Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of atorvastatin. Outcome measure for the statins part of this trial, treatment sequence C_D.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods|PK set of the statins part and assigned to atorvastatin (treatment sequence C_D).|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2636128|NCT01795937|Secondary|Cmax,ss of Faldaprevir (Statins Part)|Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C_D and E_F.|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence.|PK set of the statins part.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2637295|NCT01783015|Secondary|Number of Participants With DAS28 <2.6|Number of Participants with DAS28 <2.6. A DAS28 < 2.6 implies remission.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2636129|NCT01795937|Secondary|AUCτ,ss of Faldaprevir (Statins Part)|Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval τ (AUCτ,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C_D and E_F.|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence.|PK set of the statins part.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2636130|NCT01795937|Primary|Cmax of Atorvastatin (Statins Part)|"Maximum measured concentration of the analyte in plasma of atorvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence C_D.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods|PK set of the statins part and assigned to atorvastatin (treatment sequence C_D).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2636131|NCT01795937|Primary|AUC0-∞ of Atorvastatin (Statins Part)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of atorvastatin after single dose administration. Outcome measure for the statins part of this trial, treatment sequence C_D.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods.|"PK set of the statins part and assigned to atorvastatin (treatment sequence C_D).~Pharmacokinetic set (PK set): all treated subjects of the statins part that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2636132|NCT01795937|Primary|Cmax,ss (Itraconazole Part)|"Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the itraconazole part (Treatment sequence A_B) of this trial.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h after administration of faldaprevir on Day 1 of both periods.|PK set of the itraconazole part of this trial.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2636133|NCT01795937|Primary|AUCτ,ss (Itraconazole Part)|Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval τ (AUCτ,ss) of faldaprevir. Outcome measure for the itraconazole part (treatment sequence A_B) of this trial. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.|-1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h (hours) after administration of faldaprevir on Day 1 of both periods|pharmacokinetic (PK) set of the itraconazole part of this trial. The PK set included all treated subjects of the itraconazole part that provided at least 1 observation for at least 1 primary endpoint without important protocal violations with respect to the statistical evaluation of the PK endpoints.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2636134|NCT01795898|Primary|Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Participant|CGI-I is a 7-point scale that requires the Participant to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Day 30|The ITT population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.|||Participants|||Number
2636135|NCT01795898|Primary|Number of Participants With Clinical Global Impression-Improvement (CGI-I) Score: Clinician|CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Day 30|The ITT population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.|||Participants|||Number
2636136|NCT01795898|Primary|Number of Participants Requiring Rescue Medication|Rescue medications are periodic supplemental doses of analgesic which might be required to control pain. Tramadol 50mg tablet at a maximum of 6 tablets per day was used as standard rescue medication.|Day 30|All participants suffering from osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stuff) and chronic (lasting a long time) low back pain and who took at least 1 dose of study medication and had at least 1 follow-up visit during the study.|||Participants|||Number
2636137|NCT01795898|Primary|Change From Baseline in Brief Pain Inventory (BPI) Interference Score at Day 30|BPI is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-interference consists of 7 questions (items) that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question (item) is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. Change: Score at Day 30 minus score at Baseline.|Baseline and Day 30|The ITT population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.|||Units on a scale||Standard Deviation|Mean
2636138|NCT01795898|Primary|Change From Baseline in Brief Pain Inventory (BPI) Severity Score at Day 30|BPI is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI- severity consists of 4 questions (items) that assess pain intensity (worst, least, average, right now). Each question (item) is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. Change: Score at Day 30 minus score at Baseline.|Baseline and Day 30|The intent-to-treat (ITT) population was defined as all the participants who received at least 1 dose of study medication and had at least 1 follow-up visit with assessment.|||Units on a scale||Standard Deviation|Mean
2639613|NCT01763866|Secondary|Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL||Weeks 10 and 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2636139|NCT01795859|Secondary|Change in Berg Balance Test (BBT)|The Berg Balance Test (BBT) is a 14-item assessment of sitting, standing, transferring, and turning. Each task ranging from standing up from a sitting position, to standing on one foot each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.The scale range, which is 0-56, with higher scores indicating better balance/lower fall risk.|Baseline, 12 weeks|The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one postbaseline assessment. For subjects with missing value at Week 12, the last available assessment was used|||units on a scale||Standard Deviation|Least Squares Mean
2636140|NCT01795859|Secondary|Change in the Short Form 36 Health Survey (SF-36) Physical Functioning Score (Based on Items 3a to 3j) From Baseline to Week 12|Change in the Short Form 36 Health Survey (SF-36) physical functioning score (based on items 3a to 3j) from Baseline to Week 12. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Baseline, 12 weeks|The modified intent to treat (mITT) population will include all subjects in the ITT population who were randomized to treatment and received study drug. For subjects with missing value at Week 12, the last available assessment was used|||units on a scale||Standard Deviation|Mean
2636141|NCT01795859|Secondary|Number of Participants With Treatment Success at the End of Therapy Based on Clinical Global Impression of Change (CGIC)|A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved. The clinician was asked to comment about the subject.|12 weeks|The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one post-baseline assessment.|||Participants|||Count of Participants
2636142|NCT01795859|Secondary|Number of Participants With Treatment Success at the End of Therapy as Measured by the Patient Global Impression of Change (PGIC)|A treatment success is defined as Much or Very Much Improved at the Week 12 visit. The PGIC is a 7-point Likert Scale, ranging from very much worse to very much improved|12 weeks|The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one post baseline assessment.|||Participants|||Count of Participants
2636143|NCT01795859|Primary|Change From Baseline (Average of Screening and Day 0) in the Average TMC Scores From Weeks 9 & 12|Total TMC score is a sum of chorea scores which range 0-28, with a decrease indicating improvement in chorea|Screening, Day 0, Weeks 9, 12|The Modified ITT (mITT) Population was defined as all subjects in the ITT Population who received study drug and had at least one postbaseline assessment. For subjects who missed both Week 9 or Week 12 scores, the last available assessment was used|||Units on a scale||Standard Deviation|Least Squares Mean
2636144|NCT01795833|Secondary|Total Physical Activity|counts/minute, actigraph|Baseline and 24 months||||counts/minute||Standard Deviation|Mean
2636145|NCT01795833|Secondary|Triglycerides||Baseline and 24 months||||mmol/L||Inter-Quartile Range|Mean
2636146|NCT01795833|Secondary|LDL Cholesterol||Baseline and 24 months||||mmol/L||Standard Deviation|Mean
2636147|NCT01795833|Secondary|HDL Cholesterol||Baseline and 24 months||||mmol/L||Standard Deviation|Mean
2636148|NCT01795833|Secondary|Blood Pressure||Baseline and 24 months||||mmHg||Standard Deviation|Mean
2636149|NCT01795833|Secondary|Body Weight||Baseline and 24 months||||kg||Standard Deviation|Mean
2636150|NCT01795833|Primary|Number of Participants With Progression to Type 2 Diabetes|The primary outcome will be progression to type 2 diabetes as measured by HbA1c at baseline, 6 months, 12 months and 24 months or by any validated criteria in any other care setting. the World health Organization (WHO) / International Diabetes Federation (IDF) criteria for diagnosis of diabetes will be used throughout.|24 months||||Participants|||Count of Participants
2636151|NCT01795716|Primary|Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose||predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours post-dose||||mcg*hr/mL||Standard Deviation|Mean
2636152|NCT01795547|Secondary|Change From Baseline to Week 28 in the TooL Total Score|Tolerability and Quality of Life (TooL) is a patient-rated scale developed to measure the impact of side-effects on the quality of life in patients treated with antipsychotic medication. The TooL consists of 8 domains: mood (worry-upset), function capabilities, fatigue-weakness, weight gain, stiffness-tremor, physical restlessness, sexual dysfunction, and dizziness-nausea. Each domain was rated on a four-point scale from 1 (no impact) to 4 (maximum impact). Total scores ranged from 8 (no impact) to 32 (maximum impact).|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.|||units on a scale||Standard Error|Least Squares Mean
2636153|NCT01795547|Secondary|Change From Baseline to Week 28 in SWN-S Total Score|The SWN-S is a patient-rated scale designed to measure subjective effects of neuroleptic drugs to psychopathology, quality of life, and compliance over the past 7 days. The 20 items (10 positive and 10 negative statements) are grouped in 5 subscales (mental functioning, self-control, physical functioning, emotional regulation and social integration). Each subscale contains 4 items. Each item was rated on a six-point Likert scale, from not at all to very much. A score was calculated for each subscale, and the total score ranged from 20 to 120, where the higher score indicated better well-being.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.|||units on a scale||Standard Error|Least Squares Mean
2636163|NCT01795495|Primary|Intra- and Post-operative Pain Relief|To prospectively compare the effects of intra-operative methadone and magnesium on postoperative opioid requirements. Total amount of hydromorphone administered in OR, recovery room (PACU), and on the inpatient ward 24 hours post-operatively.|Intra-operative and 24 hours post-operatively||||mg/kg||Standard Deviation|Mean
2636164|NCT01795105|Secondary|Mean Change in the TS-CGI(Tourette's Syndrome-Clinical Global Impression-Improvement)|"Mean change in the TS-CGI from baseline to next visit(at least 6, 12 weeks interval from baseline) post-treatment~*TS-CGI scale 0=Not assessed~Normal, not at all ill~Borderline ill~Mildly ill~Moderately ill~Markedly ill~Severely ill~Extremely ill"|at least 6, 12 weeks interval from baseline||||score on a scale||Standard Deviation|Mean
2636154|NCT01795547|Secondary|Change From Baseline to Week 28 in the 'Instrumental Role' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Instrumental Role domain score was calculated as the sum of 4 items (numbers 9 to 12) giving a range of 0 to 24, where the higher score indicated less unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.|||units on a scale||Standard Error|Least Squares Mean
2636155|NCT01795547|Secondary|Change From Baseline to Week 28 in the 'Interpersonal Relations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Interpersonal Relations domain score was calculated as the sum of 8 items (numbers 1 to 8) giving a range of 0 to 48, where the higher score indicated less unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.|||units on a scale||Standard Error|Least Squares Mean
2636156|NCT01795547|Secondary|Change From Baseline to Week 28 in the 'Intrapsychic Foundations' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Intrapsychic Foundations domain score was calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21) giving a range of 0 to 42, where the higher score indicated less unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.|||units on a scale||Standard Error|Least Squares Mean
2636157|NCT01795547|Secondary|Change From Baseline to Week 28 in the 'Common Objects and Activities' QLS Domain Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). The Common Objects and Activities domain score was calculated as the sum of 2 items (numbers 18 and 19) giving a range of 0 to 12, where the higher score indicated less unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.|||units on a scale||Standard Error|Least Squares Mean
2636158|NCT01795547|Secondary|Change From Baseline to Week 28 in CGI-S Score|Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.|||units on a scale||Standard Error|Least Squares Mean
2636159|NCT01795547|Secondary|Investigator's Assessment Questionnaire (IAQ) Total Score at Week 28|The IAQ is a clinician-rated scale designed to assess the relative effectiveness (efficacy, safety and tolerability) of antipsychotic medications in patients with schizophrenia or schizoaffective disorder. The IAQ consists of 12 items: positive symptoms, negative symptoms, other efficacy symptoms, cognition, energy, mood, somnolence, weight gain, signs and symptoms of prolactin elevation, akathisia, EPS (other than akathisia) and other safety or tolerability issues. For each item, the current medication was compared with previous antipsychotic medication on a five-point scale from 1 (Much better) to 5 (Much worse), or that item is Not applicable. The sum of the 12 items ranged from 12 (the current medication was much better than previous antipsychotic medication) to 60 (the current medication was much worse than previous antipsychotic medication).|Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 4, 8, 16, and 28. Since the IAQ was assessed from week 4, the analysis was based on 133 and 131 patients|||units on a scale||Standard Error|Least Squares Mean
2636160|NCT01795547|Primary|Change From Baseline to Week 28 in Quality of Life Scale (QLS) Total Score|The QLS is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item was rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions were provided for 4 anchor points of the 7 points. Each item had a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score was calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicated normal or unimpaired functioning.|Baseline, Week 28|Effectiveness data is based on all patients who received study medicine, who had a valid baseline assessment, and at least 1 valid post-baseline assessment of the QLS (Full analysis set). Effectiveness was measured at Weeks 0, 4, 8, 16, and 28.|||units on a scale||Standard Error|Least Squares Mean
2639614|NCT01763866|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2636166|NCT01794949|Primary|Percent Stent Coverage|Assessment of vascular healing 6 months after Resolute Integrity placement in non-diabetic patients and patients with non-insulin dependent diabetes presenting with acute coronary syndrome (ACS) using optical frequency domain imaging (OFDI). Vascular healing will be measured by percent covered stents as determined by OFDI. A higher percentage of stent coverage indicates increased endothelial regrowth, which is an essential component for the maintenance of long-term luminal patency.|6 months|Participants included in the analyses for this outcome are those who completed the 6 month follow-up imaging to assess vascular healing. Optical frequency domain imaging (OFDI) was not performed on two participants in the non-diabetic study arm.|||Participants|||Count of Participants
2636167|NCT01794936|Primary|Prevalence of Intra-operative Complications|Investigators will evaluate whether any intra-operative complications resulted from the use of the VTI probe to assess safety. Specifically, this time frame is limited from the induction of anesthesia through the completion of the surgical procedure (typically ~2-3 hours)|During surgical procedure itself (~2-3 hours)|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2012.||||||
2636168|NCT01794936|Primary|Change in SHIM Score (Score of Erectile Function) Following Surgery|Patients are to be evaluated for erectile function at 8 month post-operative visit using validated SHIM questionnaire.|8 months post-operative follow-up|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2012.||||||
2636169|NCT01794845|Secondary|Estimated Overall Survival (OS)|Overall survival (OS) is defined as the length of time from the start of treatment that study participants diagnosed with the disease are still alive. OS will be measured from the start date of treatment to the date of death or last contact (censored observations).|Up to 6 years|At the time of study termination in June 2016, 1 patient had already died, 1 patient had refused follow-up, 1 patient was lost to follow-up and 1 patient was alive with disease. Overall survival data were not analyzed due to an insufficient number of evaluable participants accrued and early study termination for lack of efficacy.||||||
2636170|NCT01794845|Secondary|Estimated Progression-Free Survival (PFS)|Progression-free survival (PFS) is defined of the length of time from the start date of treatment to the earliest documented occurrence of disease progression according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria. In the absence of an event constituting failure, follow up time will be censored at the date of last disease assessment.|Up to 6 years|At the time of study termination in June 2016, 1 patient had already died, 1 patient had refused follow-up, 1 patient was lost to follow-up and 1 patient was alive with disease. Progression-free survival data were not analyzed due to an insufficient number of evaluable participants accrued and early study termination for lack of efficacy.||||||
2636171|NCT01794845|Secondary|Number of Study Participants Experiencing Treatment-Related Toxicity|"Assess the safety profile (acute and late toxicities) of the proposed treatment. Number of study participants experiencing treatment-related acute and late toxicity:~Acute toxicity is defined as toxicity occurring within 90 days of start of therapy.~Late/Long-term toxicity defined as toxicity occurring more than 90 days after start of therapy."|Up to 6 years|Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.|||Participants|||Count of Participants
2636172|NCT01794845|Primary|Overall Response Rate (ORR) of Participants|ORR is defined as the rate of study participants achieving complete response (CR) or partial response (PR) to protocol therapy according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria.|Up to 6 months from End of Treatment, about 9 months|Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.|||percentage of participants|||Number
2636173|NCT01794806|Secondary|Changes in Apico-coronal Ridge Dimension|Linear ridge height change at the mid-facial aspect of the ridge|Week 14 after tooth extraction||||millimeters||Inter-Quartile Range|Median
2636174|NCT01794806|Secondary|Changes in Bucco-lingual Ridge Dimension|Linear ridge width change at the bone crest|Baseline to Week 14 after tooth extraction||||millimeters||95% Confidence Interval|Mean
2636175|NCT01794806|Primary|Alveolar Ridge Volumetric Changes|3D reconstructions using radiographic data obtained at baseline and at 14 weeks after the intervention was utilized to calculate the reduction of bone volume that took place during the healing period in both groups|Baseline to Week 14 after tooth extraction||||percentage of volume change||Standard Deviation|Mean
2636176|NCT01794780|Secondary|Change From Baseline Questionnaire Transition Dyspnea Index (TDI) Score|Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline. BDI/TDI was used to assess dyspnea from several aspects, caused by daily activities. These were evaluated by the investigators in the study at the scheduled study visits. The indices were to be evaluated by the same investigator.as far as possible.|Baseline,3,6,9,12 months|"FAS: Two Arms/Groups were grouped together in the analysis as some of the analysis required to combine the results. Per protocol it was not the intent to compare the results between different standard of care (LABA/ICS). Efficacy data were not collected separately for the Salmeterol / fluticasone and budesonide / formoterol Arms/Groups,"|||Units on a scale||Standard Deviation|Mean
2636177|NCT01794780|Secondary|Change From Baseline in Questionnaire COPD Assessment Test (CAT) Score|The COPD assessment test (CAT) is a short instrument scale used to quantify the symptom burden of COPD and will be used to assess the health status of patients in this study. It consists of eight items, each presented as a semantic 6-point differential scale, providing a total score out of 40. A higher score indicates a worse health status. Scores of 0 - 10, 11 - 20, 21 - 30 and 31 - 40 represent a mild, moderate, severe or very severe clinical impact of COPD upon the patient.|Baseline,3,6,9,12 months|"FAS: Two Arms/Groups were grouped together in the analysis as some of the analysis required to combine the results. Per protocol it was not the intent to compare the results between different standard of care (LABA/ICS). Efficacy data were not collected separately for the Salmeterol / fluticasone and budesonide / formoterol Arms/Groups,"|||Score on a scale||Standard Deviation|Mean
2636178|NCT01794780|Secondary|Change in Health Status Questionnaire MMRC|The mMRC scale is scored from 0 (less severe) to 4 (severe). 0 Not troubled with breathlessness except with strenuous exercise; 1 Troubled by shortness of breath when hurrying on the level or walking up a slight hill; 2 Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on the level; 3 Stops for breath after walking about 100 yards or after a few minutes on the level; 4 Too breathless to leave the house or breathless when dressing or undressing. The modified Medical Research Council (mMRC) Dyspnea Scale , is a five-item instrument (part of the Borg scale) to assess a patient's degree of breathlessness in relation to physical activity. Participants will be required to read a brief description of an activity and then select a statement that best describes their experience with dyspnea at Visit 101. The mMRC was assessed by the investigators at the scheduled visits.|Baseline,3,6,9,12 months|"FAS: Two Arms/Groups were grouped together in the analysis as some of the analysis required to combine the results. Per protocol it was not the intent to compare the results between different standard of care (LABA/ICS).Efficacy data were not collected separately for the Salmeterol / fluticasone and budesonide / formoterol Arms/Groups,"|||Number of participants|||Number
2636179|NCT01794780|Secondary|COPD Exacerbation|Number of COPD exacerbations evaluated over 12 months. COPD exacerbation is defined as a new onset or worsening of at least 1 respiratory major symptoms (e.g. dyspnea, cough, sputum volume or sputum purulence) for at least 3 consecutive days, which results in recorded treatment change (antibiotics/steroids/oxygen therapy) OR recorded COPD related hospitalization/Emergency visit. COPD exacerbation is not considered as adverse event, and should only be recorded in COPD e-CRF.|Baseline,12 months|FAS: Two Arms/Groups were grouped together in the analysis as some of the analysis required to combine the results. Per protocol it was not the intent to compare the results between different standard of care (LABA/ICS)|||COPD Exacerbations/year||Standard Deviation|Mean
2636180|NCT01794780|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. A positive change from baseline in FEV1 indicates improvement in lung function. Pulmonary function tests were performed at study visits including FEV1, and Force Vital Capacity (FVC). These were performed 30 minutes before treatment and not more than 2 hours in advance after stopping the long-acting bronchodilators eight hours before visits. In order to reduce the variation between each test, the same instrument was used in the whole research process if condition allowed.|Baseline,12 months|"FAS: Two Arms/Groups were grouped together in the analysis as some of the analysis required to combine the results. Per protocol it was not the intent to compare the results between different standard of care (LABA/ICS). Efficacy data were not collected separately for the Salmeterol / fluticasone and budesonide / formoterol Arms/Groups,"|||Liters||Standard Deviation|Mean
2636181|NCT01794780|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. A positive change from baseline in FEV1 indicates improvement in lung function. Pulmonary function tests were performed at study visits including FEV1, and Force Vital Capacity (FVC). These were performed 30 minutes before treatment and not more than 2 hours in advance after stopping the Long-acting bronchodilators eight hours before visits. In order to reduce the variation between each test, the same instrument was used in the whole research process if condition allowed.|Baseline,3 months|"FAS: Two Arms/Groups were grouped together in the analysis as some of the analysis required to combine the results. Per protocol it was not the intent to compare the results between different standard of care (LABA/ICS). Efficacy data were not collected separately for the Salmeterol / fluticasone and budesonide / formoterol Arms/Groups,"|||Liters||Standard Deviation|Mean
2636182|NCT01794741|Primary|Adverse Events Report|reports of treatment emergent adverse events|3 months of treatment||||event|||Number
2636183|NCT01794702|Secondary|Overall Survival|Time from date of treatment start until date of death due to any cause or last Follow-up.|Up to 2 years after participants off study date|One of the 47 participants on the Phase II portion of this study who received study medication was not evaluable for response.|||Months||Full Range|Median
2636184|NCT01794702|Secondary|To Determine the Disease-free Survival (DFS).|Time from date of treatment start until the date of first objective documentation of return of disease.|Up to 2 years after participants off study date|One of the 47 participants on the Phase II portion of this study who received study medication was not evaluable for response.|||months||Full Range|Median
2636185|NCT01794702|Primary|Number of Participants With a Response|Primary endpoint is overall response defined as the best response either complete response, complete remission without platelet recovery, or complete remission without incomplete blood count recovery within 56 days.|56 days|One of the 47 participants on the Phase II portion of this study who received study medication was not evaluable for response.|||Participants|||Count of Participants
2636186|NCT01794702|Primary|Maximum Tolerated Dose (MTD) of Clofarabine|Maximum tolerated dose (MTD) defined as the highest dose schedule in which 6 patients were treated with at most 1 experiencing a dose-limiting toxicity (DLT). Clofarabine 15 mg/m2 IV over approximately 1 hour daily (number of days selected based on Phase I portion).|After second, 33 day cycle|"All participants in the phase I portion of the study received dose level 1 of the study medication. None of the participants experienced a DLT as defined in the protocol.~Period 1: Dose level 1 - Clofarabine 15mg/m^2 daily x 4 days (days 6-9) Period 2: Dose level-1 - Clofarabine 15mg/m^2 daily x 3 days (days 6-8)"|||mg/m^2 x 4 days (6-9)|||Number
2636187|NCT01794689|Other Pre-specified|Total Sleep Time|The degree of sleep deprivation will be assessed by total sleep time (TST) in minutes during the uninterrupted sleep condition compared to the forced awakenings conditions.|Next day during quantitative sensory testing after 2 nights of forced awakenings or uninterrupted sleep.|Each participant had to do four visits to be termed complete. The data needed for analysis for this outcome measure was obtained from some participants but not all who completed or couldn't complete the entire study. This explains the differences in the numbers analyzed for each total sleep time.|||minutes||Standard Deviation|Mean
2636240|NCT01793688|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator.|14 Days|The safety analysis set comprised of participants who satisfied the inclusion criteria of the study, and who had been received sulbactam sodium/ampicillin sodium at least once.|||Participants|||Number
2636188|NCT01794689|Secondary|Mean Change in Percentage of Peripheral Blood Mononuclear Cells Expressing Interleukin-6 After LPS Stimulation|After 2 nights of forced awakenings, and two nights of uninterrupted sleep, blood is drawn (approximately every 60 minutes) during quantitative sensory testing; 4 hours pre-morphine/placebo administration and 2 hours post-morphine/placebo administration to examine markers of inflammation. Two blood samples for each participant are analyzed at 7 separate time points. The marker of inflammation assessed is the number of peripheral blood mononuclear cells expressing Interleukin-6 (IL-6), and the outcome measure represents the mean change in IL-6 levels pre and post stimulation with lipopolysaccharide (LPS). Cellular IL-6 expression was was quantified via flow cytometry.|Next day after 2 nights of forced awakenings or uninterrupted sleep, every 60 minutes up to 7 hours|For some participants we could not collect blood samples for all time points and testing sessions. This explains the differences in the numbers of samples analyzed at various timepoints.|||percentage of IL-6 expression|blood samples|Standard Deviation|Mean
2636189|NCT01794689|Secondary|Opioid Analgesia as Assessed by Analgesia Index (Seconds)|After 2 nights of forced awakenings and after two nights of uninterrupted sleep, opioid analgesia will be assessed by an analgesia index. The analgesia index is calculated using withdrawal latency during cold pressor testing (lasting maximum of 300 seconds). Cold Pressor Testing is done before and after morphine or placebo injection. The difference in withdrawal time before and after morphine or placebo injection is the analgesia index with a minimum score of -300 seconds and maximum score of 300 seconds. These data were log transformed. Mean analgesia index was then calculated for each group. Higher means represent greater analgesia.|Next day after 2 nights of forced awakenings or uninterrupted sleep|Each participant had to do four visits and two testing sessions to be termed complete. The data needed for analysis for this outcome measure was obtained from some participants but not all who completed or couldn't complete the entire study. This explains the differences in the number of units analyzed.|||seconds (log transformed)|cold pressor test|Standard Deviation|Mean
2636190|NCT01794689|Primary|Spinal Sensitization as Assessed by Area of Secondary Hyperalgesia (2HA) After Two Nights of Uninterrupted Sleep and Two Nights of 8 Forced Awakenings|The area of secondary hyperalgesia (2HA) to mechanical stimulation was quantified by stimulating along eight linear paths near the capsaicin treated site using a 15 gram nonpainful von Frey filament. Stimulation occurred until the participant reported a change in sensation from which a border was marked on the skin. The degree of 2HA was assessed by measuring the total surface area (mm^2) of the marked borders. Data were collapsed by group to analyze the effects of FA vs US, irrespective of randomization group. Our Primary Secondary Hyperalgesia outcome was measured prior to injection of either morphine or placebo.|Next day during quantitative sensory testing after 2 nights of forced awakenings or uninterrupted sleep||||mm^2||Standard Deviation|Mean
2636191|NCT01794455|Secondary|MRI Arterial Spin Labeling|MRI arterial spin labeling is a noninvasive approach to measuring cerebral blood flow. This relates to the Phase 2 candesartan arm.|Change from week 8 to week 20|MRI data could not be obtained on the one study participant due to MRI contraindications.||||||
2636192|NCT01794455|Secondary|Montgomery-Asberg Depression Rating Scale|MADRS is a measure of depression severity (range 0 - 60, higher scores indicate more severe depressive symptoms). This outcome applies to the candesartan Phase 2 arm.|Week 20||||units on a scale|||Number
2636193|NCT01794455|Secondary|Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16)|Self-report measure of depression severity (range 0 - 27, higher scores indicate more severe depressive symptoms). This applies to the candesartan Phase 2 arm.|Week 20||||units on a scale|||Number
2636194|NCT01794455|Secondary|Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16)|Self-report measure of depression severity. This applies to the sertraline Phase 1 arm.|Week 8|||||||
2636195|NCT01794455|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|MADRS is a measure of depression severity. This outcome applies to the sertraline Phase 1 arm.|Week 8|||||||
2636196|NCT01794455|Primary|MRI Arterial Spin Labeling|MRI arterial spin labeling is a noninvasive approach to measuring cerebral blood flow. This relates to the Phase 1 sertraline arm.|Change in perfusion from baseline to week 8|Could not complete MRI.||||||
2636197|NCT01794312|Secondary|Best Corrected Visual Acuity|Change from baseline in far best-corrected visual acuity (LogMAR) in the pathologic eye|Baseline and Day 28|Safety set|||LogMAR||Standard Deviation|Mean
2636198|NCT01794312|Secondary|Number of Participants With at Least One Treatment-emergent Adverse Event|With at least one TEAE|From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days|Safety Set|||Participants|||Count of Participants
2636199|NCT01794312|Primary|Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28|Reduction in neurotrophic ulcer/keratitis area of 50% or more|Day 28|"Modified Intent to treat (m-ITT): All randomised patients received at least 1 IMP dose, with at least 1 baseline and 1 post-baseline efficacy assessment.~For the primary outcome measure, 4 patients (2 in the T4020 and Vehicle groups) had no data for the reduction from baseline of corneal ulcer/keratitis area and were not included in this analysis"|||Participants|||Count of Participants
2636200|NCT01794039|Secondary|Time to Progression|The distribution of time to progression will be estimated using the method of Kaplan-Meier. The International Myeloma Working Group (IMWG) uniform response criteria (Rajkumar et al, 2011) will be used to assess response to therapy.|Time from registration to the earliest date with documentation of disease progression, assessed up to 2 years|All patients that received Arm A or Arm B treatment.|||Months||95% Confidence Interval|Median
2636201|NCT01794039|Secondary|Overall Survival|The distribution of survival time will be estimated using the method of Kaplan-Meier. Due to an early closer from slow accrual the data from both arms was combined in survival analysis.|Time from registration to death due to any cause, assessed up to 2 years|All patients that received Arm A or Arm B treatment.|||Months||95% Confidence Interval|Median
2636202|NCT01794039|Secondary|Number of Participants With Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Recorded and reported for each patient, and frequency tables will be reviewed to determine adverse event patterns. These results are reported in the Adverse Events section of this CT.gov report.|Up to 30 days after last day of study drug treatment|All treated patients are evaluable for Adverse Events|||Participants|||Count of Participants
2637296|NCT01783015|Secondary|Number of Participants With DAS28 <3.2|Number of participants with DAS28 <3.2. A score of < 3.2 implied low disease activity.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2636203|NCT01794039|Primary|Proportion of Confirmed Tumor Responses Defined to be a Partial Response or Better Noted as the Objective Status on Two Consecutive Evaluations|The proportion of successes will be estimated in each arm independently by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. A confirmed tumor response is defined to be a partial response or better noted as the objective status on two consecutive evaluations while receiving lenalidomide and dexmethasone (Arm A) or pomalidomide and dexamethasone (Arm B). All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.The International Myeloma Working Group (IMWG) uniform response criteria (Rajkumar et al, 2011) will be used to assess response to therapy.|Up to 2 years|All patients that received treatment were evaluable for response|||proportion of participants||95% Confidence Interval|Number
2636204|NCT01794000|Secondary|Percentage of Participants With Hemorrhagic Events Requiring Medical Intervention|Medical intervention was defined as any medical evaluation resulting in therapy or further investigation, as determined by a trained medical professional. Data collected from the first dose of study medication through 10 days after last dose of study medication during the double blind study period are presented below.|First Dose through 24 Months|All randomized participants who received at least one dose of drug.|||Percentage of Participants|||Number
2636205|NCT01794000|Secondary|Time From Randomization to First and Second VOC|Data collected through the primary completion date are presented below.|Randomization to First VOC and Second VOC respectively (up to 24 Months)|All randomized participants.|||Days||95% Confidence Interval|Median
2636206|NCT01794000|Secondary|Number of Days Hospitalized for VOC|The total length of hospitalization in days for VOC was calculated for each participant. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants who were hospitalized for VOC.|||Days||Standard Error|Least Squares Mean
2636207|NCT01794000|Secondary|Time to First Transient Ischemic Attack (TIA)/Ischemic Stroke||Randomization through 24 Months|No participants had a TIA or ischemic stroke at time of analysis.||||||
2636208|NCT01794000|Secondary|Quarterly Rate of School Absence Due to Sickle Cell Pain|Quarterly rate of school absence due to sickle cell pain was measured through participant diaries and was calculated for each participant by summing the number of days with school absence due to sickle cell pain divided by the number of school dates in the quarter. A quarter was defined as 12 weeks. The quarterly rate was set to missing if there were more than 6 weeks of missing diary entries during a specific quarter. Data collected through the primary completion date are presented below.|Randomization through 9 Months|All Randomized participants who are 4 years or older and have both baseline and at least one post-baseline quarterly outcome measure in any quarter. Diaries were only provided to participants 4 years and older.|||Percentage of Days in a Quarter||Standard Error|Least Squares Mean
2636209|NCT01794000|Secondary|Monthly Rate of Days of Analgesic Use|Monthly rate of days of analgesic use was measured through participant diaries and was calculated for each participant by summing the number of days they reported analgesic use divided by the number of diary entries completed in the month. A month was defined as 4 weeks (28 days). The monthly rate was set to missing if there were more than 14 missing entries for analgesic use in a specific month. Data collected through the primary completion date are presented below.|Randomization through 9 Months|All randomized participants who are 4 years or older and have baseline and at least one post-baseline monthly outcome measure in any month. Diaries were only provided to participants 4 years and older.|||Percentage of Days in a Month||Standard Error|Least Squares Mean
2636210|NCT01794000|Secondary|Number of Red Blood Cell (RBC) Transfusions Due to Sickle Cell Disease (SCD) Per Participant Per Year (Rate of RBC Transfusions)|RBC transfusions that occurred within 7 days of the prior event onset date were not counted as a new episode. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants.|||Number of Events per Participant-Year|||Number
2636211|NCT01794000|Secondary|Number of Acute Chest Syndrome Per Participant Per Year (Rate of Acute Chest Syndrome)|Acute chest syndrome was defined as an acute illness characterized by fever and/or respiratory symptoms, accompanied by a new pulmonary infiltrate on a chest X-ray. Acute chest syndrome that occurred within 7 days of the prior event onset date was not counted as a new episode. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants.|||Number of Events per Participant-Year|||Number
2636212|NCT01794000|Secondary|Number of Hospitalizations for VOC Per Participant Per Year (Rate of Hospitalizations)|Hospitalization that occurred within 7 days of the prior event onset date were not counted as a new episode. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants.|||Number of Events per Participant-Year|||Number
2636213|NCT01794000|Secondary|Number of Painful Crisis Events Per Participant Per Year (Rate of Painful Crisis)|A painful crisis is defined as an onset of moderate to severe pain that lasts at least 2 hours for which there is no explanation other than vaso-occlusion and which requires therapy with oral or parenteral opioids, ketorolac, or other analgesics prescribed by a health care provider (HCP) in a medical setting such as a hospital, clinic, emergency room visit, or telephone management. The painful crisis that occurred within 7 days from the prior event onset date was not counted as a new episode. Data collected through the primary completion date are presented below.|Randomization through 24 Months|All randomized participants.|||Number of Events per Participant-Year|||Number
2636214|NCT01794000|Secondary|Monthly Mean in Faces Pain Scale-Revised Score|Each day participants selected the face on the FPS-R scale that reflected their worst pain related to sickle cell disease (SCD) on that day. Monthly mean in FPS-R score was calculated for each participant by summing the FPS-R score divided by the number of non-missing diary entries completed in the month. This pain scale contains six faces corresponding to the pain intensity of 0, 2, 4, 6, 8 or 10, in which 0 denotes no pain and 10 denotes the worst pain possible. A month was defined as 4 weeks (28 days). The monthly mean in FPS-R score was set to missing if there were more than 14 missing entries for the FPS-R in a specific month. Data collected through the primary completion date are presented below.|Randomization through 9 Months|All randomized participants who are 7 years or older and have both baseline and at least one post-baseline monthly outcome measure in any month. This is the Sickle cell population in which content validity has been established for the FPS-R.|||Units on a Scale||Standard Error|Least Squares Mean
2636215|NCT01794000|Secondary|Monthly Rate of Days With Pain|Monthly rate of days with pain was measured through participant diaries using a modified version of the Faces Pain Scale-Revised (FPS-R). Each day participants selected the face on the scale that reflected their worst pain related to sickle cell disease (SCD) on that day. This pain scale contains six faces corresponding to the pain intensity of 0, 2, 4, 6, 8 or 10, in which 0 denotes no pain and 10 denotes the worst pain possible. Any day the participant selected a face other than face 0 was considered a day with pain. Monthly rate of days with pain was calculated for each participant by summing the number of days reported with any pain divided by the number of non-missing diary entries completed in the month. A month was defined as 4 weeks (28 days).The monthly rate was set to missing if there were more than 14 missing entries for the FPS-R in a specific month. Data collected through the primary completion date are present below.|Randomization through 9 Months|All randomized participants who are 7 years or older and have both baseline and at least one post-baseline monthly outcome measure in any month. This is the Sickle cell population in which content validity has been established for the FPS-R.|||Percentage of Days in a Month||Standard Error|Least Squares Mean
2636216|NCT01794000|Primary|Number of Vaso-Occlusive Crisis (VOC) Events Per Participant Per Year (Rate of VOC)|The VOC is a composite endpoint of painful crisis or acute chest syndrome. Events that occurred within 7 days from the prior event onset date were not counted as a new episode. Data collected through the primary completion date reported below.|Randomization through 24 Months|All randomized participants.|||Number of Events per Participant-Year|||Number
2636217|NCT01793935|Other Pre-specified|Laboratory Analytes|"Changes in laboratory analytes will be classified as normal or abnormal (example: white blood cell counts)"|Change from Baseline in Laboratory Analytes at 12 weeks or end of study|||||||
2636218|NCT01793935|Other Pre-specified|Vital Signs - Temperature|"Clinically significant changes in Temperature will be assessed for normal or abnormal following randomization to 12 weeks or end of study."|Baseline and 12 weeks or end of study|34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes|||degrees F||Standard Deviation|Mean
2636219|NCT01793935|Other Pre-specified|Vital Signs - Pulse|"Clinically significant changes in Pulse will be assessed for normal or abnormal following randomization to 12 weeks or end of study."|Baseline and 12 weeks or end of study|34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes|||beats/min||Standard Deviation|Mean
2636220|NCT01793935|Other Pre-specified|Vital Signs - Blood Pressure Systolic and Diastolic|"Clinically significant changes in BP will be assessed for normal or abnormal following randomization to 12 weeks or end of study."|Baseline and 12 weeks or end of study|34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes|||mm/Hg||Standard Deviation|Mean
2636221|NCT01793935|Other Pre-specified|Vital Signs - Body Mass Index|"Clinically significant changes in BMI will be assessed for normal or abnormal following randomization to 12 weeks or end of study."|Baseline and 12 weeks or end of study|34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes|||kg/m^2||Standard Deviation|Mean
2636222|NCT01793935|Other Pre-specified|Vital Signs - Weight|"Clinically significant changes in weight will be assessed for normal or abnormal following randomization to 12 weeks or end of study"|Baseline and 12 weeks or end of study|34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes|||lbs||Standard Deviation|Mean
2636223|NCT01793935|Secondary|Immune Marker S-100B|"Changes in immune marker S-100B will be assessed in response to study medication.~Elisa~Sensitivity 2.7 picogm/ml~Range 2.7 to 2000 picogm/ml"|Baseline and 12 weeks or end of treatment|"The number analyzed differs from the overall number of participants analyzed because not all participants had baseline and end of treatment values for S-100B."|||pg/mL||Standard Deviation|Mean
2636224|NCT01793935|Secondary|Immune Marker Hs-CRP (High Sensitivity C Reactive Protein)|"Changes in immune marker hs-CRP (high sensitivity C Reactive Protein) will be assessed in response to study medication.~hsCRP - mg/L"|Baseline and 12 weeks or end of study|"The number analyzed differs from the overall number of participants analyzed because not all participants had baseline and end of treatment values for hs-CRP."|||mg/L||Standard Deviation|Mean
2636225|NCT01793935|Secondary|Immune Marker IFN-Y (Gamma)|Changes in immune marker IFN-Y (gamma) will be assessed in response to study medication.|Baseline and 12 weeks or end of study|data cannot be summarized IFN-Y (gamma) levels undetectable|||pg/mL||Standard Deviation|Mean
2636226|NCT01793935|Secondary|Immune Marker IL-6|Changes in immune marker IL-6 will be assessed in response to study medication.|Changes from Baseline in Immune markers at 12 weeks or end of study|"The number analyzed differs from the overall number of participants analyzed because not all participants had baseline and end of treatment values for IL-6."|||pg/mL||Standard Deviation|Mean
2636227|NCT01793935|Secondary|Immune Marker IL-4|Changes in immune marker IL-4 will be assessed in response to study medication.|Baseline and12 weeks or end of study|Data cannot be summarized- IL-4 levels undetectable|||pg/mL||Standard Deviation|Mean
2636228|NCT01793935|Secondary|Immune Marker IL-2|Changes in immune marker IL-2 will be assessed in response to study medication.|Baseline and 12 weeks or end of study|IL-2 levels undetectable.|||pg/mL||Standard Deviation|Mean
2636229|NCT01793935|Secondary|Number of Participants With a Score of 1, 2, or 3 on the Clinical Global Impression Improvement Scale|"The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: Possible ratings are: 1= Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5= Minimally worse, 6= Much worse, 7=Very much worse.~The higher the score the worse outcome"|12 weeks|34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes|||Participants|||Count of Participants
2636230|NCT01793935|Secondary|Clinical Global Impression Scale (CGI-S) - Severity|The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are: 0 = not assessed, 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Among the most extremely ill patients - The higher the score the worse outcome|Baseline and 12 weeks or end of study|34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes|||units on a scale||Standard Deviation|Mean
2636231|NCT01793935|Secondary|Perceived Stress Scale (PSS)|"The Perceived Stress Scale (PSS) was developed to measure the degree to which situations in one's life are appraised as stressful.~Perceived Stress Scale Scoring Each item is rated on a 5-point scale ranging from never (0) to very often (4). Positively worded items are reverse scored, and the ratings are summed, with higher scores indicating more perceived stress.~PSS-10 scores are obtained by reversing the scores on the four positive items:~For example, 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4, 5, 7, and 8 are the positively stated items. Total score can range from 0 to 40. Scores around 13 are considered average. Scores of 20 or higher are considered high stress,"|Baseline and 12 weeks or end of treatment|34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes|||units on a scale||Standard Deviation|Mean
2636232|NCT01793935|Primary|Positive and Negative Syndrome Scale (PANSS)|"The Positive and Negative Syndrome Scale (PANSS) measures symptom severity in patients with psychotic illnesses. It yields a total score as well as subscores for Positive symptoms, Negative symptoms and General symptoms.~PANSS Positive subscale consists of 7 Items - (minimum score = 7, maximum score = 49) - Higher values represent a worse outcome.~PANSS Negative subscale consists of 7 Items - (minimum score = 7, maximum score = 49) - Higher values represent a worse outcome.~General Psychopathology subscale consists of 16 items - (minimum score = 16, maximum score = 112) - Higher values represent a worse outcome.~PANSS Total Score - The 3 subscales scores are summed to compute a PANSS Total score. The minimum PANSS total score = 30, maximum = 210 - Higher values represent a worse outcome"|Baseline and 12 Weeks|34 subjects were randomized to each treatment group, but 1 subject in each group did not return to pick up study medication and therefore were not included in the Intention-to-Treat (ITT) sample for analysis of outcomes|||units on a scale||Standard Deviation|Mean
2636233|NCT01793909|Primary|Change in Muscle Oxygen Saturation|The investigators evaluated the dynamics of muscle deoxygenation (O2 extraction) using near infrared spectroscopy (NIRS) during single leg plantar flexion exercise to identify the predominant mechanisms of oxygen delivery versus oxygen utilization abnormalities in the muscle of T2DM during the transition from rest to exercise. These measurements were gathered continuously for 2-5 minutes of multiple exercise bouts within two visits, one prior to the exercise intervention period and one post exercise intervention.|4.5 hrs each, pre- and post- Exercise Intervention||||percentage||Standard Deviation|Mean
2636234|NCT01793883|Primary|Time to Alleviation of Influenza Symptoms|Time to alleviation of influenza will be assessed through Flu-iiQ (Influenza intensity and impact Questionnaire) and diary cards from Day 1 to 14.|Efficacy will be assessed over 14 days post-randomization.|Intent-to-treat-infected (ITT-I) population - all ITT subjects with laboratory confirmed influenza A or B infection by at least one virological method (qRT-PCR or qCulture) on either Day 1 or 3|||hours||95% Confidence Interval|Median
2636235|NCT01793792|Primary|Primary Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months||12 months||||Participants|||Count of Participants
2636236|NCT01793792|Primary|"Primary Effectiveness Composite Success Number of Participants With Primary Effectiveness Composite Success (100% Aneurysm Occlusion Without Clinically Significant In-stent Stenosis or Target Aneurysm Retreatment"||12 months||||Participants|||Count of Participants
2636237|NCT01793688|Secondary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. Expectedness of the adverse event was determined according to Japanese package insert. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator.|14 Days|The safety analysis set comprised of participants who satisfied the inclusion criteria of the study, and who had been received sulbactam sodium/ampicillin sodium at least once.|||Participants|||Number
2636238|NCT01793688|Secondary|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to sulbactam sodium/ampicillin sodium in a participant who received sulbactam sodium/ampicillin sodium. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to sulbactam sodium/ampicillin sodium was assessed by the investigator.|14 Days|The safety analysis set comprised of participants who satisfied the inclusion criteria of the study, and who had been received sulbactam sodium/ampicillin sodium at least once.|||Participants|||Number
2636239|NCT01793688|Primary|Clinical Effectiveness Rate by Indication|Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of participants with assessable effectiveness evaluation, was presented by each indication (pneumonia, lung abcess and peritorinitis) along with the corresponding exact 2-sided 95% confidence interval. Overall effectiveness of sulbactam sodium/ampicillin sodium was determined by the investigator based on clinical symptoms and examinations at the end of high-dose (>6 g daily) treatment. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable at the end of treatment.|14 Days|The effectiveness analysis set comprised of participants in safety analysis set who had effectiveness evaluation at least once.|||Percentage of participants||95% Confidence Interval|Number
2636263|NCT01793142|Secondary|Number of Participants With Osteoporosis Related Fractures||Baseline up to 3 months|Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once.|||Participants|||Count of Participants
2636241|NCT01793285|Secondary|Time to Treatment Discontinuation With Etanercept|Time to treatment discontinuation with etanercept was assessed retrospectively at Year 3 for participants who did not discontinue treatment at the end of previous LoadET study 0881A3-102090 (NCT00873730). It was defined as time from first dose of etanercept received in the previous LoadET study 0881A3-102090 (NCT00873730) to last dose of etanercept.|Year 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure.|||years||95% Confidence Interval|Mean
2636242|NCT01793285|Secondary|Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels|Lipid profile included following parameters: Total Cholesterol (TC), high-density lipoprotein (HDL) and triglycerides (TGs).|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for each parameter at specified time point.|||milligram per deciliter (mg/dL)||Inter-Quartile Range|Median
2636243|NCT01793285|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||mm/hr||Inter-Quartile Range|Median
2636244|NCT01793285|Secondary|C-reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||milligram per milliliter (mg/mL)||Inter-Quartile Range|Median
2636245|NCT01793285|Secondary|Chest Expansion Measurement|Chest expansion, measured in cm (rounded to the nearest 0.1 cm), is defined as the difference in thoracic circumference during full expiration versus full inspiration, measured at the fourth intercostal space (nipple line). Chest expansion was measured for both maximum and minimum inhalation. The measurement of two attempts was made.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||cm||Inter-Quartile Range|Median
2636246|NCT01793285|Secondary|Occiput-to-wall Distance|Occiput-to-wall distance: distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight. The distance between the occiput and the wall was measured in cm (rounded to the nearest 0.1 cm), in two attempts.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||cm||Inter-Quartile Range|Median
2636247|NCT01793285|Secondary|Modified Schober's Test|Measurement in centimeters (cm) of the distance between marks originally placed while the participant was standing erect 10 cm above and 5 cm below the midpoint of a line that joints the posterior superior iliac spines. Distance between marks was re-measured (in cm rounded to the nearest 0.1 cm) with participant maximally bend forward, knees fully extended, with spine in full flexion. The measurement of two attempts was made.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||cm||Inter-Quartile Range|Median
2636248|NCT01793285|Secondary|Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|"Participant's fatigue was assessed by answering question 1 of BASDAI on a 0 to 10 VAS; participants were asked: How would you describe the overall level of fatigue/tiredness you have experienced? 0=none and 10=very severe."|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||units on a scale||Inter-Quartile Range|Median
2636249|NCT01793285|Secondary|Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|"Participant's spinal pain - was assessed by answering question 2 of BASDAI on a 0 to10 VAS; participants were asked: How would you describe the overall level of ankylosing spondylitis neck, back or hip pain you have had? 0 =none and 10 =very severe."|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||units on a scale||Inter-Quartile Range|Median
2636250|NCT01793285|Secondary|Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|BASDAI is a validated self-assessment tool used to determine disease activity in participant with ankylosing spondylitis. Utilizing a VAS of 0-10, 0=none and 10=very severe participant's answered 6 questions measuring discomfort, pain and fatigue. The final BASDAI score is a sum of the individual assessments. Final score ranged from 0-60, higher score indicates higher disease activity.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||units on a scale||Inter-Quartile Range|Median
2636251|NCT01793285|Secondary|Bath Ankylosing Spondylitis Functional Index (BASFI)|BASFI is a validated self-assessment tool that determines the degree of functional limitation in ankylosing spondylitis. Utilizing a VAS of 0-10, 0 = easy, 10 = impossible, participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a sum of the scores of the 10 questions, final score ranged from 0-100, where higher score referred to higher impairment in the functional ability.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||units on a scale||Inter-Quartile Range|Median
2636252|NCT01793285|Secondary|Patient Global Assessment (PtGA) of Disease Activity Score|Participants disease activity assessed using a 100 millimeter (mm) Visual Analog Scale (VAS), ranging from 0 = very good to 100 = very bad.|Baseline, Year 1, 2, 3|Analysis population included all evaluable participants who continued the treatment at 3 years after the finalizing of the LoadET study (0881A3-102090). Here, N (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point.|||mm||Inter-Quartile Range|Median
2636253|NCT01793285|Secondary|Number of Participants Who Received Pharmacological Treatment|Participants who received any pharmacological treatment (non-steroidal anti-inflammatory drugs [NSAIDs], disease-modifying antirheumatic drugs [DMARDs], corticosteroids and other treatments including anti-tumor necrosis factor-alpha [TNFalpha] or other biological agents etc.) in the 3 years since the last LoadET study 0881A3-102090 (NCT00873730) visit were reported.|Baseline up to Year 3|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.|||participants|||Number
2636254|NCT01793285|Secondary|Number of Participants Who Received Non-pharmacological Treatment|Participants who received any non-pharmacological treatment (participant education, regular exercises and physical therapy) in the 3 years since the last LoadET study 0881A3-102090 (NCT00873730) visit were reported.|Baseline up to Year 3|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.|||participants|||Number
2636255|NCT01793285|Secondary|Time to Diagnosis of Ankylosing Spondylitis|Time to first diagnosis of alkylosing spondylitis was reported.|Baseline|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.|||years||Standard Deviation|Mean
2636256|NCT01793285|Secondary|Time Between the Onset of Ankylosing Spondylitis Symptoms and First Visit to the Rheumatologist|Time passed since the ankylosing spondylitis symptoms started until the participant arrived for the first time to visit the rheumatologist was reported. Ankylosing spondylitis symptoms may include pain, stiffness, axial manifestations, and enthesitis etc.|Baseline|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.|||years||Standard Deviation|Mean
2636257|NCT01793285|Primary|Percentage of Participants Who Discontinued Treatment With Etanercept|Participants who discontinued etanercept following 3 years after finalization of LoadET study 0881A3-102090 (NCT00873730) due to any of these reason were reported: adverse events, failure in therapeutic response, disease remission and discontinued for other causes.|Baseline up to Year 3|Analysis population included all participants who had previously participated in the LoadET study (NCT00873730) and fulfilled all the eligibility criteria.|||percentage of participants|||Number
2636258|NCT01793142|Secondary|Number of Participants With Abnormal Biochemical Markers of Bone Turnover|In this study biochemical markers of bone turnover included C-telopeptide of collagen cross links (CTX), osteocalcin and bone specific alkaline phosphatase. Criteria for abnormality was based on investigator's discretion.|Baseline up to 3 months|"Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once. Here, n (number analyzed) signifies the number of participants with available data for each category."|||Participants|||Count of Participants
2636259|NCT01793142|Secondary|Number of Participants With Abnormal Bone Mineral Density Result|A bone mineral density test examines segments of bone through X-rays to detect osteoporosis. Criteria for abnormality was based on investigator's discretion.|Baseline up to 3 months|"Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once. Here, N signifies number of participants analyzed for this outcome measure."|||Participants|||Count of Participants
2636260|NCT01793142|Secondary|Number of Participants With Abnormal X-ray Result|Criteria for abnormality was based on investigator's discretion.|Baseline up to 3 months|"Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once. Here, N signifies number of participants analyzed for this outcome measure."|||Participants|||Count of Participants
2636261|NCT01793142|Primary|Number of Participants With Treatment Related Adverse Drug Reactions (ADRs), Serious ADRs, and Unexpected ADRs|"An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious AEs. All AEs, except for those with causal relationship to the study drug assessed as unlikely or no, were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the local product document and confirmed by Pfizer. Treatment related ADRs included all ADRs with causality related to treatment as judged by the investigator."|Baseline up to 28 days after last dose of Viviant 20 mg (up to 6 months)|Safety analysis set included all participants who received Viviant 20 mg tablet at least once and completed the follow up.|||Participants|||Count of Participants
2636262|NCT01793142|Secondary|Number of Participants With Abnormal Dual Energy X-Ray Absorptiometry (DXA)|DXA is established standard for measuring bone mineral density. Criteria for abnormality was based on investigator's discretion.|Baseline up to 3 months|"Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once. Here, N (number of participants analyzed) signifies number of participants analyzed for this outcome measure."|||Participants|||Count of Participants
2636264|NCT01793142|Secondary|Overall Efficacy Evaluation of Viviant 20 mg Tablet|Efficacy evaluation of Viviant 20 mg tablet was carried out on the basis of the assessment of clinical response by the treating physician. Clinical response among participants were assessed by the physician as improved, no change, worsened and unevaluable for efficacy.|Baseline up to 3 months|Efficacy analysis set included all participants who received Viviant 20 mg tablet at least once and completed evaluation of efficacy endpoints at least once.|||Participants|||Count of Participants
2636265|NCT01793142|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of Viviant 20 mg tablet, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.|Baseline, up to 28 days after last dose of Viviant 20 mg (up to 6 months)|Safety analysis set included all participants who received Viviant 20 mg tablet at least once and completed the follow up.|||Participants|||Count of Participants
2636266|NCT01792986|Secondary|Difference in Red Blood Cell Count Between Baseline and the End of the Sixth Week.||6 weeks||||trillion cells/L||Standard Deviation|Mean
2636267|NCT01792986|Secondary|Difference in Human Growth Hormone (HGH) Between Baseline and the End of the Sixth Week.||6 weeks||||ng/mL||Standard Deviation|Mean
2636268|NCT01792986|Secondary|Difference in Low-density Lipoprotein Cholesterol (LDL-C) Between Baseline and the End of the Sixth Week.||6 weeks||||mg/dL||Standard Deviation|Mean
2636269|NCT01792986|Secondary|Difference in Weight Between Baseline and the End of the Sixth Week||6 weeks||||kg||Standard Deviation|Mean
2636270|NCT01792986|Primary|Difference in Mean Glucose Level Between Baseline and the End of the Sixth Week.||6 weeks||||mg/dL||Standard Deviation|Mean
2636271|NCT01792830|Secondary|Number of Participants Experiencing a Hyperglycemic Event|The number of participants that experienced hyperglycemia, defined as blood glucose levels ≥ 140 mg/dl.|3 months after discharge|Participants who completed the Month 3 study visit, in person or by phone.|||Participants|||Count of Participants
2636272|NCT01792830|Secondary|The Number of Participants Experiencing a Severe Hypoglycemic Event|The number of participants that experienced severe hypoglycemia, defined as blood glucose levels ≤ 40 mg/dl.|3 months after discharge|Participants who completed the Month 3 study visit in person or by phone.|||Participants|||Count of Participants
2636273|NCT01792830|Secondary|The Number of Participants Experiencing a Hypoglycemic Event|The number of participants that experienced hypoglycemia, defined as blood glucose levels ≤70 mg/dl.|3 months after discharge|This analysis includes participants who completed the month 3 study visit either in person or by phone.|||Participants|||Count of Participants
2636274|NCT01792830|Secondary|Number of Participants Readmitted to the Hospital|The number of participants that were readmitted to the hospital 3 months after initial hospital discharge|3 months after discharge|This analysis includes participants who completed the month 3 study visit either in person or by phone.|||participants|||Number
2636275|NCT01792830|Primary|Efficacy, Measured by a Change in HbA1c Levels|Change in the level of HbA1c in a one month period after discharge from the hospital. The A1c test result is reported as a percentage. Higher percentages indicate higher blood glucose levels in the previous three months. A normal HbA1c level is below 5.7 percent.|One month after hospital discharge|"This analysis includes participants who had blood drawn one month after hospital discharge. Most patients that completed the discharge part did so over the phone. The diabetic, HbA1C <7%, metformin and insulin glargine is not included in this table as no participants in this group had blood drawn for this analysis."|||percent of glycosylated hemoglobin||Standard Deviation|Mean
2636276|NCT01792817|Secondary|Incidence and Occurrence of Serious Adverse Events Related to Active or Sham Study Treatment and / or to Cluster Headache Events.|The primary safety measure for this study is the incidence and occurrence of serious adverse events related to active or sham study treatment and / or to cluster headache events during Phase 1 of the study.|4 weeks, Phase 1||||Serious Adverse Events|||Number
2636277|NCT01792817|Secondary|Average Mean Attack Intensities Experienced Per Subject|Cluster headache attack intensity was reported on a 5-point scale: no pain, mild, moderate, severe, very severe, whereas no pain =1 is the best outcome and very severe=5 is the worst outcome . The average of all subjects' mean attack intensities experienced at 15 minutes post-initiation of treatment during Phase 1 for the active treatment group, compared to the sham control group. The mean 15-minute scores were calculated for the first five attacks suffered by each subject during Phase 1. For subjects with fewer than five treated attacks, the scores for those available were averaged.|15 minutes post-stimulation|There were 4 subjects with no data in the Sham GammaCore group and 13 subject in the GammaCore group.|||Score on a scale||Standard Deviation|Mean
2636278|NCT01792817|Secondary|Sustained Treatment Success at 1 Hour Post-Treatment|Sustained treatment success at 1 hour post-treatment was defined as having recorded an intensity of 0 or 1 on the 5-point headache pain scale at 15 minutes and 1 hour post-initiation of treatment of the first treated cluster headache attack of Phase 1, and having refrained from use of rescue medications during the full 60 minute period|For 1 hour post stimulation||||Participants|||Count of Participants
2636279|NCT01792817|Primary|Number of Participants With Repsonse to Treatment|"The primary outcome measurement for effectiveness is the rate of responders for the active treatment group, compared to the sham control group.~A responder is defined as a subject who has recorded an intensity of 0 or 1 on the 5-point headache pain scale (no pain, mild, moderate, severe, very severe) at 15 minutes post-initiation of treatment of the first treated cluster headache attack of Phase 1."|15 minutes post stimulation|Intent to treat study population|||Participants|||Count of Participants
2636280|NCT01792635|Secondary|Ra in Part B in PF-05175157 200 mg BID Group|Ra in fasting state and during insulin infusions (Step 1 and Step 2).|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.|||mg/kg BW/min||Full Range|Mean
2640472|NCT01754402|Secondary|Time to Next Therapy|Time to next Therapy - defined as the time elapsed for patients from initiation of study therapy until initiation of next therapy|up to 2 years|||||||
2636281|NCT01792635|Secondary|Ra in Part B in Placebo Group|Ra in fasting state and during insulin infusions (Step 1 and Step 2).|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.|||mg/kg BW/min||Full Range|Mean
2636282|NCT01792635|Secondary|EGP in Part B in PF-05175157 200 mg BID Group|EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2)|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.|||mg/kg fat free mass (FFM)/min||Full Range|Median
2636283|NCT01792635|Secondary|EGP in Part B in Placebo Group|EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2)|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.|||mg/kg fat free mass (FFM)/min||Full Range|Median
2636284|NCT01792635|Secondary|GIR in Part B in PF-05175157 200 mg BID Group|Glucose Infusion Rate rates obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion.|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.|||mg/min||Full Range|Mean
2636285|NCT01792635|Secondary|GIR in Part B in Placebo Group|Glucose Infusion Rate rates obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion.|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.|||mg/min||Full Range|Mean
2636286|NCT01792635|Primary|Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarisation Criteria in Part B|Criteria for PCI changes in ECG (12-lead) were defined as: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval) >=300 milliseconds (msec) and increase of >=25% from baseline when baseline >200 msec or increase of >=50% when baseline less than or equal to (<=) 200 msec; the time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS interval) >=140 msec and increase of >=50% from baseline; the time corresponding to the beginning of depolarization to repolarization of the ventricles (QT), corrected for heart rate (QTc) using the Fridericia formula (QTcF) of 450 to < 480 msec and >=480 msec, or an increase from baseline of 30 to <60 msec or >=60 msec.|Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)|All participants who were admitted to the CRU on Day -5.|||Participants|||Number
2636287|NCT01792635|Primary|Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria in Part B|Criteria for potentially clinical important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of less than (<) 90 millimeters of mercury (mm Hg) or change in sitting SBP of greater or equal to (>=)30 mm Hg, sitting diastolic blood pressure (DBP) of <50 mm Hg or change in sitting DBP of >=20 mm Hg, sitting pulse rate of <40 or greater than (>) 120 beats per minute (bpm).|Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)|All participants who were admitted to the CRU on Day -5|||Participants|||Number
2636288|NCT01792635|Primary|Number of Participants With Laboratory Test Abnormalities in Part B|Number of participants with laboratory test abnormalities without regard to baseline abnormality. The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, and creatine phosphokinase); urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, and microscopy); others (follicle stimulating hormone [FSH], urine drug screen, lipid profile and very-low-density lipoproteins [VLDL], hemoglobin A1c [HbA1c], C-peptide, thyroid-stimulating hormone [TSH], Hepatitis B and C, human immunodeficiency virus [HIV], triglycerides, urine creatinine).|Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration)|All participants who were admitted to the Clinical Research Unit (CRU) on Day -5|||Participants|||Number
2636289|NCT01792635|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) in Part B|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline to follow-up (up to approximately 10 to 14 days after the last study drug administration)|All participants who were admitted to the clinical research unit (CRU) on Day -5|||Participants|||Number
2636290|NCT01792635|Primary|Whole-body Glucose Uptake in Part B in PF-05175157 200 mg BID Group|Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.|||mg/kg BW/min||Full Range|Mean
2636291|NCT01792635|Primary|Whole-body Glucose Uptake in Part B in Placebo Group|Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp|6 weeks|Part B of the study was terminated due to the safety issue. Due to the limited participant number who completed study there no summary statistics were done by dosing regimen for Part B.|||mg/kg BW/min||Full Range|Mean
2636292|NCT01792635|Primary|Whole-body Glucose Uptake in Part A|Whole-body glucose uptake (Rate of glucose disappearance, Rd) during the Step 2 Clamp|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp.|||mg/kg BW/min||90% Confidence Interval|Mean
2640473|NCT01754402|Secondary|Time to Progression|Time to progression - defined as time elapsed in patients between achievement of response and disease progression|up to 2 years|||||||
2636293|NCT01792635|Primary|Rate of Appearance of Glucose (Ra) in Part A|Rate of appearance of glucose (Ra) in fasting state and during insulin infusions (Step 1 and Step 2).|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp.|||mg/kg BW/min||Full Range|Mean
2636294|NCT01792635|Primary|[6,6-2H2] Plasma Glucose Enrichment (PGE) in Part A|[6,6-2H2] PGE was the molar fraction of labeled glucose measured in plasma. Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity.|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp|||percentage enrichment of plasma glucose||90% Confidence Interval|Mean
2636295|NCT01792635|Primary|Endogenous Gucose Production (EGP) in Part A|EGP measured by means of euglycemic hyperinsulinemic clamp preceding insulin infusion (EGP0), on Step 1 insulin infusion (EGP1) and on Step 2 insulin infusion (EGP2). Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity. EGP was measured under basal conditions; then during the low dose insulin infusion EGP was partially suppressed (hepatic insulin sensitivity), while during the high dose insulin infusion, EGP was almost completely suppressed and peripheral glucose uptake was maximally stimulated (peripheral insulin sensitivity).|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp|||mg/kilogram (kg) body weight (BW)/min||Full Range|Median
2636296|NCT01792635|Primary|Glucose Infusion Rates (GIR) in Part A|GIR obtained averaging respectively the last 30 minutes of glucose infusion at steady state on Step 1 (ie 150 to 180 min) and Step 2 (ie 330 to 360 min) insulin infusion. Whole-body insulin sensitivity was assessed with the euglycemic hyperinsulinemic clamp procedure; the use of 2 stepped insulin infusions and labeled glucose allowed the differentiation between hepatic and peripheral insulin sensitivity. Assessment of whole body insulin sensitivity was performed during the steady states of the low insulin infusion rate (ie, Step 1) and during the steady state of the high insulin infusion rate (ie, Step 2). These indices were called GIR1 and GIR2, respectively.|1 day|All participants randomized and who had at least one euglycemic hyperinsulinemic clamp|||mg/min||90% Confidence Interval|Mean
2636297|NCT01792518|Secondary|The Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 24 Weeks of Treatment|"The change from baseline in estimated glomerular filtration rate (eGFR) as assessed by chronic kidney disease epidemiology collaboration (CKD-EPI) equation (cystatin C) after 24 weeks of treatment. The term baseline refers to the last observation before the start of any randomised trial treatment. The number of participants analysed displays the number of participants with available data at the timepoint of interest. This outcome measure is a secondary safety endpoint."|Baseline and 24 weeks|Treated Set|||milliliter/minute/1.73 square metre||Standard Error|Least Squares Mean
2636298|NCT01792518|Secondary|The Time Weighted Average of Percentage Change From Baseline in UACR During the Course of 24 Weeks of Treatment|"The time weighted average of percentage change from baseline in UACR (mg/g creatinine) during the course of 24 weeks of treatment. The term baseline for UACR refers to the geometric mean of UACR values measured at Visits 2 and 3. The number of participants analysed displays the number of participants with available data at the timepoint of interest. The Least Squares Means are adjusted geometric means."|Baseline and 24 weeks|Full Analysis Set (FAS) - including all randomised patients who were treated with at least one dose of study drug, had a baseline HbA1c and a baseline Urinary albumin creatinine ratio (UACR), and at least one on treatment HbA1c or UACR assessment. Last Observation Carried Forward (LOCF).|||mg/g creatinine||95% Confidence Interval|Least Squares Mean
2636299|NCT01792518|Primary|HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment|"Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double- blind trial medication. The term baseline refers to the last observation before the start of any randomised trial treatment. The number of participants analysed displays the number of participants with available data at the timepoint of interest."|Baseline and 24 weeks|Full Analysis Set (FAS) - including all randomised patients who were treated with at least one dose of study drug, had a baseline HbA1c and a baseline Urinary albumin creatinine ratio (UACR), and at least one on treatment HbA1c or UACR assessment. Observed Case (OC): Values after the use of rescue medication were set to missing.|||Percentage of HbA1c||Standard Error|Least Squares Mean
2636300|NCT01792284|Secondary|Percentage of Participants With HbA1c <7.0% and ≤6.5% at 12 Weeks|The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.|At 12 Weeks in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable HbA1c data.|||percentage of participants|||Number
2636301|NCT01792284|Secondary|Change From Day 1 of Lead-in to 36 Weeks in Triglycerides, Total Cholesterol, Low-Density Lipoprotein Cholesterol (LDL-C), and High-Density Lipoprotein Cholesterol (HDL-C)|LS means were calculated using MMRM analysis including visit and baseline lipid level (last nonmissing value at or before the beginning of Lead-in) as covariates.|Day 1 of Lead-In Period, 36 Weeks|All enrolled participants who completed the first visit of the Lead-in Period, received at least 1 dose of study drug, and had evaluable lipid data.|||mg/dL||Standard Error|Least Squares Mean
2636302|NCT01792284|Secondary|0300-Hour Blood Glucose to Fasting Blood Glucose Excursion|Excursion results were calculated by subtracting the 0300 hours glucose value from the next day pre-morning glucose value within a single SMBG profile. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline 0300-hour to next day pre-breakfast excursion (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|At 12 Week in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable SMBG excursion data.|||mg/dL||Standard Error|Least Squares Mean
2636393|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Hemoglobin Levels Over Time|The mean change in hemoglobin concentration was calculated by subtracting the baseline hemoglobin concentration from the monthly hemoglobin concentration is reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.|||gram/dL||Standard Deviation|Mean
2636303|NCT01792284|Secondary|Proportion of Bolus to Total Insulin Doses at 12 Weeks|Proportion of bolus to total insulin dose is presented, where LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline proportion of bolus to total insulin dose (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|At 12 Weeks in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable bolus to total insulin dose data.|||units/day||Standard Error|Least Squares Mean
2636304|NCT01792284|Secondary|Basal, Bolus, and Total Insulin Doses at 12 Weeks|LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline insulin dose (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|At 12 Weeks in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable insulin dose data.|||units/kg/day||Standard Error|Least Squares Mean
2636305|NCT01792284|Secondary|Participants With Treatment-Emergent Anti-LY2605541 Antibody Response|The number of participants with a treatment emergent anti-LY2605541 antibody response (TEAR) is presented. Positive TEAR was defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from 1) undetectable to detectable or from 2) detectable to the value with at least 130% relative increase from baseline.|Day 1 of Lead-in Period through 36 Weeks|Participants who completed the first visit of the Lead-in Period, received at least 1 dose of study drug, and had evaluable anti-LY2605541 antibody data.|||participants|||Number
2636306|NCT01792284|Secondary|Change From Randomization to 12 Weeks in HbA1c|LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline HbA1c (last nonmissing value at or before randomization), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|Randomization, 12 Weeks in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable HbA1c data.|||percentage of HbA1c||Standard Error|Least Squares Mean
2636307|NCT01792284|Secondary|Change From Day 1 of Lead-In Period to 36 Weeks in Body Weight|LS means were calculated using MMRM analysis, including visit and baseline weight (last non-missing value at or before the beginning of Lead-in Period) as covariates.|Day 1 of Lead-In Period, 36 Weeks|All enrolled participants who completed the first visit of the Lead-in Period, received at least 1 dose of study drug, and had evaluable body weight data.|||kg||Standard Error|Least Squares Mean
2636308|NCT01792284|Secondary|Change From Randomization to 12 Weeks in Body Weight|LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline body weight (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|Randomization, 12 Weeks in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable body weight data.|||kilograms (kg)||Standard Error|Least Squares Mean
2636309|NCT01792284|Secondary|Intra-participant Variability in SMBG at 12 Weeks|A summary of glucose variability (intra-participant variability) as measured by the average of between-day standard deviations of individual SMBG time points. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline intra-participant variability in SMBG (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|At 12 Week in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable SMBG variability data.|||mg/dL||Standard Error|Least Squares Mean
2636310|NCT01792284|Secondary|Self-Monitored Blood Glucose (SMBG) at 12 Weeks|SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the subsequent morning prior to the morning meal. SMBG measures were assessed at Weeks 0, 4, 8, and 12 within each Randomization Period. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline SMBG (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|At 12 Week in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable SMBG data.|||mg/dL||Standard Error|Least Squares Mean
2636311|NCT01792284|Secondary|Change From Randomization to 12 Weeks in 9-Point SMBG|SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the subsequent morning prior to the morning meal. SMBG measures were assessed at Weeks 0, 4, 8, and 12 within each Randomization Period. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline SMBG (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|Randomization, 12 Weeks in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable SMBG data.|||mg/dL||Standard Error|Least Squares Mean
2636312|NCT01792284|Secondary|Fasting Serum Glucose (FSG) at 12 Weeks|LS means for FSG (obtained from clinical laboratory tests) were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline FSG (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|At 12 Weeks in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable FSG data.|||mg/dL||Standard Error|Least Squares Mean
2636394|NCT01791205|Secondary|Phase II: Number of Side Effects That Induced Transient Interruption of Treatment|Number of side effects (AEs) that induced transient interruption of treatment is reported. The AEs were captured only for Phase II.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||AEs|||Number
2641088|NCT01749956|Secondary|Sphincter Preservation Rate|The percentage of patients who had Low Anterior Resection during surgery..|Between days 57 and 98 after preoperative chemotherapy.||||percentage of patients|||Number
2636313|NCT01792284|Secondary|Intra-Participant Variability of FBG at 12 Weeks|FBG was measured by SMBG. Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline intra-participant variability in FBG (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|At 12 Weeks in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable FBG data.|||mg/dL||Standard Error|Least Squares Mean
2636314|NCT01792284|Secondary|Fasting Blood Glucose (FBG) Measured by Self-Monitored Blood Glucose|FBG was measured by self-monitored blood glucose (SMBG). LS means were calculated using MMRM analysis including the following fixed effects: treatment, period, sequence, baseline FBG (last nonmissing value at or before randomization), baseline HbA1c (<=8.0% or >8.0%), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|At 12 Weeks in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable FBG data.|||mg/dL||Standard Error|Least Squares Mean
2636315|NCT01792284|Secondary|Percentage of Participants With Total and Nocturnal Hypoglycemic Events|Total HE include any event based on a blood glucose <=70 mg/dL (3.9 mmol/L), with or without signs/symptoms of hypoglycemia or an event associated with signs/symptoms of hypoglycemia but without a glucose measurement. Nocturnal HE include any total HE that occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.|Baseline (Day 1) of Randomization Period through 24 weeks (12 weeks in each Randomization Period)|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable HE data during Randomization Periods|||percentage of participants|||Number
2636316|NCT01792284|Secondary|30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events|Total hypoglycemic events (HE) include any event based on a blood glucose <=70 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]), with or without signs/symptoms of hypoglycemia or an event associated with signs/symptoms of hypoglycemia but without a glucose measurement. Nocturnal HE include any total HE that occurred between bedtime and waking. Group Means are presented and were calculated from negative binomial regression models (number of episodes = treatment + period + treatment sequence + baseline HbA1c [<=8.0% or >8.0%], with log [exposure in days/30] as an offset variable). Group Mean (LS mean) is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.|Baseline (Day 1) of Randomization Period through 24 Weeks (12 weeks in each Randomization Period)|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable HE data during Randomization Periods.|||events/participant/30 days||Standard Error|Least Squares Mean
2636317|NCT01792284|Primary|Hemoglobin A1c (HbA1c) at 12 Weeks|HbA1c is a test that measures a person's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis including the following fixed effects: treatment, period, sequence, baseline HbA1c (last nonmissing value at or before randomization), week (defined from the start of each Randomization Period), and treatment-by-week interaction.|At 12 Week in Each Randomization Period|Participants who were randomized, received at least 1 dose of study drug after randomization, and had evaluable HbA1c data.|||percentage of HbA1c||Standard Error|Least Squares Mean
2636318|NCT01792024|Secondary|Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM)|Sexual Health Inventory Score in Men (SHIM) measures sexual health and erectile function and it ranged 1 to 25. Lower values are considered better outcome.|At 1,3 and 12 months||||units on a scale||Full Range|Median
2636319|NCT01792024|Secondary|Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS)|International Prostate Symptom Score (IPSS) measures urinary symptoms and continence and it ranged 0 to 35. Lower values are considered better outcome.|At 1,3 and 12 months||||units on a scale||Full Range|Median
2636320|NCT01792024|Secondary|The Total Number of Patients With Any Adverse Events Related to the Treatment|Treatment-related toxicity measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0|1,3, and 12 month after treatment and up to 12 months||||Participants|||Count of Participants
2636321|NCT01792024|Secondary|The Number of Patients With Biopsy Cancer of the Treatment Zone|A systematic 12-core biopsy was performed at 1 year and the number of patients with biopsy cancer was counted.|At 12 months||||Participants|||Count of Participants
2636322|NCT01792024|Primary|Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment|The primary study end point was the number of patients with no cancer on MRI guided biopsy of the ablation zone at 3 months.|At 3 months after ablation||||Participants|||Count of Participants
2636323|NCT01791972|Secondary|Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was >20%|Participants were classified as unprotected if the maximum percentage decrease from baseline FEV1 after exercise was more than 20%. Data represents the number of participants who were classified as unprotected.|Days 1 and 7; up to 60 minutes post-exercise challenge|Full analysis set|||participants|||Number
2636324|NCT01791972|Secondary|Percentage of Participants Whose Maximum Percentage Decrease From the Baseline Forced Expiratory Volume in 1 Second (FEV1) Post-Exercise Challenge Was <10%|Participants were classified as protected if the maximum percentage decrease from baseline FEV1 after exercise was less than 10%. Data represents the percentage of participants who were classified as protected.|Days 1 and 7; up to 60 minutes post-exercise challenge|Full analysis set|||percentage of participants|||Number
2636373|NCT01791244|Secondary|Number of Subjects With Response Based on Health Care Personnel Satisfaction Questionnaire at Month 12|"The subject satisfaction questionnaire was defined as satisfaction with overall treatment and support from health care providers during the last 12 months. Subjects were asked to rate their satisfaction by choosing either Very unsatisfied, unsatisfied, satisfied or very satisfied."|Month 12|"ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, Overall Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure."|||Subjects|||Number
2636325|NCT01791972|Primary|Maximum Percentage Fall From Baseline in Forced Expiratory Volume in 1 Second (FEV1) up to 60 Minutes After the Exercise Challenge|"A centralized spirometry data collection system was used to reduce FEV1 variability between and within patients and between each participating study center.~The percentage fall was defined as 100*(baseline-post baseline)/baseline. The baseline FEV1 is the test day FEV1 measured 5 minutes before the exercise challenge (30 minutes postdose). FEV1 post exercise challenge were measured 5 (±5), 10 (±5), 15 (±5), 30 (±5), and 60 (±10) minutes after completion of the exercise challenge.~The exercise challenge consisted of the participant running on a motor-driven treadmill (with adjustable speed and incline). The treadmill was set at a speed and incline sufficient to increase the participant's heart rate to ≥80% of the maximum rate for age (220 bpm-age in years) for a period of either 6, 7, or 8 minutes using a stepped-exercise protocol in accordance with ATS guidelines (American Thoracic Society 2000). Conditions were repeated for subsequent challenges."|Days 1 and 7; up to 60 minutes post-exercise challenge|Full analysis set|||percentage change from baseline FEV1||Standard Error|Mean
2636326|NCT01791894|Secondary|Incidence of Grade 3/4 Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0||Baseline to cycle 3||||number of occurrences|||Number
2636327|NCT01791894|Secondary|Patients With Progressive Disease Post Treatment by RECIST Criteria|Patients with a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|After 3 treatment cycles (approx. 61 days)||||participants|||Number
2636328|NCT01791894|Secondary|Patients With Stable Disease Post Treatment|Number of patients with stable disease post treatment by RECIST criteria|After 3 cycles of treatment (approx. 61 days)|4 patients completed 3 cycles of treatment|||participants|||Number
2636329|NCT01791894|Primary|Percent Change in Biomarker (GLI2 Protein) Levels||baseline to day 33|We recruited patients with biopsy-confirmed metastatic basal cell carcinoma who were had progressed on SMO inhibitors such as vismodegib (GDC 0449), IPI- 926, LEQ506 and LDE225.|||percentage decrease||Standard Deviation|Mean
2636330|NCT01791803|Secondary|Smoking Abstinence Rate at 12 and 26 Weeks|Abstinence rates were calculated for patients hospitalized with a cardiac or a pulmonary diagnosis.|12 weeks and 26 weeks after hospital discharge|Abstinence comparing the 2 admitting diagnoses was similar within each arm, thus analysis for admitting diagnosis was done combining the 4 arms.|||percentage of smoking abstinence rate|||Number
2636331|NCT01791803|Secondary|Smoking Cessation|Abstinence from smoking at 12 weeks after hospitalization was measured by self reported 7-day prevalence and verified urinary Cotinine test. This included participants in groups receiving hypnotherapy, NRT or both. Self quit group was not approached until 26 weeks after discharge. Patients lost to follow up were considered smokers.|at 12 weeks after hospitalization||||Participants|||Count of Participants
2636332|NCT01791803|Primary|Abstinence From Smoking|Assessed by 7-day prevalence of verified tobacco abstinence at 26 weeks after hospitalization for a cardiopulmoanry illness. Verification was confirmed biochemically by urine Cotinine testing or by telephone and discussion with a household proxy. Patients lost to follow up were considered to be persistent smokers.|at 26 weeks after hospitalization||||percentage of participants|||Number
2636333|NCT01791725|Other Pre-specified|Improvement in NPI Total Scores in Subjects With NPI Score ≥1 at Baseline Baseline|The Neuropsychiatric Inventory(NPI) (Cummings et al 1994) is a behavioral measure that assesses psychopathology in dementia patients. The NPI was administered at the Baseline Visit (Day 1) and at Day 28 (EOS) or ET. A decrease in score shows an improvement in symptoms.|Baseline and 4 weeks|Subjects with NPI Score ≥1 at baseline|||participants|||Number
2636334|NCT01791725|Other Pre-specified|Cognitive Outcome (RADD Total Score)|Rapid Assessment for Development Disabilities (RADD) The RADD test was developed from the low-difficulty items from published intelligence tests (Walsh et al 2007). It was specifically developed for evaluation of individuals with intellectual disabilities and developmental disabilities. It is a validated and reliable cognitive screening instrument that can be rapidly administered. The RADD is composed of 76 items. Each item is scored as 0 (incorrect) or 1 (correct).The test assesses a wide range of functional abilities including receptive and expressive language, orientation, registration, recall, attention, self identification, motor skills, imitation, abstract reasoning, number skills, comprehension and short-term memory to give a total score. Scores are from 0 to 76. A higher total score is correlated with a higher Cognitive Impairment level.|Baseline and 4 Weeks||||units on a scale||Standard Deviation|Mean
2636335|NCT01791725|Other Pre-specified|Pharmacokinetic Assessment|Mean Plasma ELND005 Concentrations- Cmax|Baseline and 4 Weeks||||μg/mL||Standard Deviation|Mean
2636336|NCT01791725|Other Pre-specified|Changes From Baseline in Abnormal Neurological Examination Results|Subjects with Abnormal Neurological Examination Results|Baseline and 4 weeks||||participants|||Number
2636337|NCT01791725|Primary|Incidence of Adverse Events (TEAEs)|For all AE summaries, if a patient had more than one AE within a preferred term, the patient was counted only once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a SOC, the subject was similarly counted only once when reporting results for that SOC.|4 weeks||||participants|||Number
2636338|NCT01791517|Primary|Overall Comfort Score (Etafilcon A Lens)|CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the etafilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).|2-Week Follow-up|The analysis population consists of all subjects that have completed all study visits without a major protocol deviation. The number of subjects reported above is the maximum number of subjects for that solution. The number of subjects may vary per solution/lens combination, since this study was stratified by contact lens.|||units on a scale||Standard Deviation|Mean
2636392|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Hematocrit, Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes Over Time|Mean Change from Baseline in hematocrit, neutrophils, eosinophils, basophils, lymphocytes, monocytes are reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.|||Percentage of cells||Standard Deviation|Mean
2636339|NCT01791517|Primary|Overall Comfort Score (Galyfilcon A Lens)|CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the galyfilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).|2-Week Follow-up|The analysis population consists of all subjects that have completed all study visits without a major protocol deviation. The number of subjects reported above is the maximum number of subjects for that solution. The number of subjects may vary per solution/lens combination, since this study was stratified by contact lens.|||units on a scale||Standard Deviation|Mean
2636340|NCT01791517|Primary|Overall Comfort Score (Senofilcon A Lens)|CLUE overall comfort is assessed using the Contact Lens User Experience (CLUE)TM questionnaire for the senofilcon A lens only. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).|2-Week Follow-up|The analysis population consists of all subjects that have completed all study visits without a major protocol deviation. The number of subjects reported above is the maximum number of subjects for that solution. The number of subjects may vary per solution/lens combination, since this study was stratified by contact lens.|||units on a scale||Standard Deviation|Mean
2636341|NCT01791491|Secondary|Percentage of CD86 Receptor Occupancy|Blood samples collected following the single dose belatacept infusion were assessed for CD86 receptor occupancy (CD86 RO).|0.5 hours post dose on Day 1, Day 29 and Day 57|Pharmacodynamic analysis set: all participants who received one dose of belatacept and who had at least 1 pharmacodynamic result (CD86 RO) reported after that dose.|||percent||Standard Deviation|Mean
2636342|NCT01791491|Secondary|Number of Participants With Positive Belatacept-induced Immunogenicity Response|Serum samples were analyzed for anti-belatacept antibodies using a validated homogenous bridging assay. The assay followed a tiered approach consistent with health authority guidance: tier 1 for screening ADA responses, tier 2 for confirming drug specificity of the ADA-positive responses, and tier 3 for titer. A neutralizing antibody assay was used to test those samples positive to the LEA29Y portion of the molecule in tier 2 and for which drug concentrations are =>1 μg/mL. Lack of immunogenicity was defined as the absence of a positive response.|Baseline/Day 1, Days 15, 29, and 57|All treated participants who received at least one dose of belatacept.|||participants|||Number
2636343|NCT01791491|Primary|Volume of Distribution at Steady-state (Vss) of Belatacept|"Vss was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to zero which was 0.003 micrograms per milliliter (ug/mL). Vss was measured in liters per kg body weight (L/kg)."|Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57|Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination.|||Liters per kilogram||Geometric Coefficient of Variation|Geometric Mean
2636344|NCT01791491|Primary|Total Body Clearance (CLT) of Belatacept|"CLT was the volume of abatacept cleared by the system, normalized by baseline body weight. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to zero which was 0.003 micrograms per milliliter (ug/mL). CLT was measured in milliliters per hours per kilogram of body weight (mL/h/kg)."|Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57|Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination.|||milliliters per hours per kilogram||Geometric Coefficient of Variation|Geometric Mean
2636345|NCT01791491|Primary|Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC (0-T)) and Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Belatacept|"AUC (0 - T) and AUC (0 - INF) were derived from serum concentration versus time data and measured in microgram hours per milliliter (µg*h/mL). Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to zero which was 0.003 micrograms per milliliter (ug/mL)."|Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57|Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination.|||microgram hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
2636346|NCT01791491|Primary|Half-Life of Elimination (T-Half) of Belatacept|"T-HALF was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to zero which was 0.003 micrograms per milliliter (ug/mL). T-HALF was measured in hours (h)."|Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57|Pharmacokinetic (PK) analysis set: all participants who received one dose of belataceptand who had at least 1 blood sample drawn for PK determination.|||hours||Standard Deviation|Mean
2636347|NCT01791491|Primary|Time of Maximum Observed Plasma Concentration (Tmax) of Belatacept|"Tmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to zero which was 0.003 micrograms per milliliter (ug/mL). Tmax was measured in hours (h)."|Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57|Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination.|||hours||Full Range|Median
2636348|NCT01791491|Primary|Maximum Observed Serum Concentration (Cmax) of Belatacept|"Cmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: pre-dose (0 hours), 0.5 and 2 hours from Start of Infusion on Day 1, Day 29, and Day 57. The results were summarized. The lower limit of assay quantitation (LLOQ) was set to zero which was 0.003 micrograms per milliliter (ug/mL). Cmax was measured in micrograms per milliliter."|Pre-dose (0), 0.5hr and 2hr from the start of infusion on Day 1, Day 29, and Day 57|Pharmacokinetic (PK) analysis set: all participants who received one dose of belatacept and who had at least 1 blood sample drawn for PK determination.|||micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2636349|NCT01791491|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), and Treatment-related Adverse Event (AE)|Death was a fatal event leading to permanent cessations of all vital functions of the body. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment related=having certain, probable, possible, or missing relationship to study drug.|Date of First Dose to 24 weeks post the last dose; approximately 26 weeks|All treated participants who received at least one dose of belatacept.|||participants|||Number
2636350|NCT01791465|Secondary|Waist to Hip Ratio at Baseline and 16 Weeks||baseline and 16 weeks||||ratio||Inter-Quartile Range|Mean
2636351|NCT01791465|Secondary|Hip Circumference at Baseline and 16 Weeks||baseline and 16 weeks||||centimeters||Inter-Quartile Range|Mean
2636352|NCT01791465|Secondary|Waist Circumference at Baseline and 16 Weeks||baseline and 16 weeks||||centimeters||Inter-Quartile Range|Mean
2636353|NCT01791465|Secondary|Body Weight at Baseline and 16 Weeks||baseline and 16 weeks||||kilograms||Inter-Quartile Range|Mean
2636354|NCT01791465|Other Pre-specified|Peripheral Endothelial Tonography, as Measured by the Non-invasive EndoPAT System Using the LnRHI (Natural Log of Reactive Hyperemia Index), at Baseline and 16 Weeks|Normal: LnRHI > 0.51 Abnormal: LnRHI ≤ 0.51|baseline and 16 weeks||||units on a scale||Inter-Quartile Range|Mean
2636355|NCT01791465|Secondary|Serum LDL Cholesterol Levels at Baseline and 16 Weeks||baseline and 16 weeks||||mg/dL||Inter-Quartile Range|Mean
2636356|NCT01791465|Secondary|Serum HDL Cholesterol Levels at Baseline and 16 Weeks||baseline and 16 weeks||||mg/dL||Inter-Quartile Range|Mean
2636357|NCT01791465|Secondary|Serum Total Cholesterol Levels at Baseline and 16 Weeks||baseline and 16 weeks||||mg/dL||Inter-Quartile Range|Mean
2636358|NCT01791465|Secondary|Serum Triglycerides Levels at Baseline and 16 Weeks||baseline and 16 weeks||||mg/dL||Inter-Quartile Range|Mean
2636359|NCT01791465|Secondary|Serum Hemoglobin A1c (HbA1c) Levels at Baseline and 16 Weeks||baseline and 16 weeks||||percentage of glycated haemoglobin||Inter-Quartile Range|Mean
2636360|NCT01791465|Secondary|Serum TNF-a Receptor 2 Levels at Baseline and 16 Weeks||baseline and 16 weeks||||pg/ml||Inter-Quartile Range|Mean
2636361|NCT01791465|Secondary|Serum Soluble CD14 Levels at Baseline and 16 Weeks||baseline and 16 weeks||||pg/ml||Inter-Quartile Range|Mean
2636362|NCT01791465|Secondary|Serum TNF-a Receptor 1 Levels at Baseline and 16 Weeks||baseline and 16 weeks||||pg/ml||Inter-Quartile Range|Mean
2636363|NCT01791465|Secondary|Body Mass Index at Baseline and 16 Weeks||16 weeks||||kg/m2||Inter-Quartile Range|Mean
2636364|NCT01791465|Secondary|Serum Adipokine Leptin Levels at Baseline and 16 Weeks||baseline and 16 weeks||||ng/ml||Inter-Quartile Range|Mean
2636365|NCT01791465|Secondary|Oral Glucose Insulin Sensitivity (OGIS) at Baseline and 16 Weeks|The Oral Glucose Insulin Sensitivity (OGIS) is a method for the assessment of insulin sensitivity from the oral glucose tolerance test. OGIS provides an index which is analogous to the index of insulin sensitivity obtained from the glucose clamp. OGIS values for glucose clearance are reported in units of ml/min per square meter of body surface area. Lower values indicate slower glucose clearance and higher insulin resistance.|baseline and 16 weeks||||ml/min/m^2 BSA||Inter-Quartile Range|Mean
2636366|NCT01791465|Secondary|Serum Macrophage Inflammatory Protein 1 Alpha (MIP-1 Alpha) Levels at Baseline and 16 Weeks||baseline and 16 weeks||||pg/ml||Inter-Quartile Range|Mean
2636367|NCT01791465|Secondary|Serum Macrophage Chemotactic Protein-1 (MCP-1) Levels at Baseline and 16 Weeks||baseline and 16 weeks||||pg/ml||Inter-Quartile Range|Mean
2636368|NCT01791465|Secondary|Serum Soluble Tumor Necrosis Factor Alpha (TNF-α) Levels at Baseline and 16 Weeks||baseline and 16 weeks||||pg/ml||Inter-Quartile Range|Mean
2636369|NCT01791465|Primary|Serum Interleukin 6 (IL-6) at Levels at Baseline and 16 Weeks|The primary outcome will be the change in serum IL-6 levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.|baseline and 16 weeks||||mg/dl||Inter-Quartile Range|Median
2636370|NCT01791465|Primary|Serum Highly-sensitive C-reactive Protein (hsCRP) Levels at Baseline and 16 Weeks|The primary outcome will be the change in hsCRP levels from baseline (pre-treatment) to 16 weeks of Bydureon treatment.|baseline and 16 weeks|Change in hsCRP over 16 weeks of treatment|||mg/dl||Inter-Quartile Range|Median
2636371|NCT01791413|Primary|Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation||Within the first 2 weeks and 3 months after surgery||||percentage of serum AMH change||Inter-Quartile Range|Median
2636372|NCT01791244|Secondary|Number of Subjects With Lifestyle Goals for MinSupport Plus at Month 12|Subjects defined up to 4 personal lifestyle goals during the first study week. Subjects completed the following questions related to lifestyle goals achieved during this study: 1. Was the goal achieved? (Yes/No) 2. If yes, better than expected or achieved as expected? 3. If better than expected, a lot or a little better than expected? 4. If no, a little or a lot less than expected?|Month 12|"ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, n signifies subjects who were evaluable for the specific goal in this outcome measure."|||Subjects|||Number
2636395|NCT01791205|Secondary|Phase II: Number of Side Effects That Had Not Induced Discontinuation of Treatment|Number of side effects (AEs) that had not induced discontinuation of treatment is reported. The AEs were captured only for Phase II.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||AEs|||Number
2636374|NCT01791244|Secondary|Number of Subjects With Response Based on Subject Satisfaction Questionnaire at Month 12|"The subject satisfaction questionnaire was defined as satisfaction with overall treatment and support from health care providers during the last 12 months. Subjects were asked to rate their satisfaction by choosing either Very discontented, discontented, contented or Very contented."|Month 12|"ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, Number of Subjects Analyzed signifies those subjects who were evaluable for this outcome measure."|||Subjects|||Number
2636375|NCT01791244|Secondary|Number of Subjects With Response Based on Lifestyle Questionnaire for (MinSupport Plus) at Month 6 and 12|Lifestyle Questionnaire was used to assess the quality of life for subjects based on following parameters: Stress, Alcohol, Cost, Physical Aspect, Sleep, Activity and Smoking. Subjects provided their responses on the basis of three color codes: Green, Orange and Red, where Green refers to - no problem; Orange refers to - some problem and red refers to - definite/debilitating problem.|Month 6 and 12|ITT population was used. Here, “Overall Number of Participants Analyzed” signifies those subjects who were evaluable for this outcome Measure and “n” signifies those subjects who were evaluable for specified time points, respectively.|||Subjects|||Number
2636376|NCT01791244|Secondary|Percentage of Subjects With Adverse Events (AE) up to Month 12|AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment Emergent Adverse Events (TEAEs) include both Serious TEAEs and non-serious TEAEs.|Baseline up to Month 12|The Safety Population included all subjects who were randomized and received at least 1 dose of trial treatment.|||Percentage of Subjects|||Number
2636377|NCT01791244|Secondary|Number of Subjects With Working Ability at Month 12|Working ability was assessed by measuring the number of subjects for the following categories: 1) Subjects with full sickness/disability pension, 2) Subjects who were employed or had their own business, 3) Subjects who were retired, 4) Subjects who were studying, 5) None of the above.|Month 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, “Overall Number of subjects analyzed” signifies those subjects who were evaluable for this outcome Measure.|||Subjects|||Number
2636378|NCT01791244|Secondary|Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Month 6 and 12|Hospital Anxiety and Depression Scale (HADS) was used to measure depression and anxiety in patients. The scale was limited to 14 questions, a practical tool for identifying and quantifying the two most common forms psychological disturbances in medical subjects. 7 of the items relate to anxiety and 7 relate to depression. Each item on the questionnaire was scored from 0-3 giving a total score between 0 and 21 for either anxiety or depression where higher score indicates more anxiety/depression.|Baseline, Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.|||units on a scale||Standard Deviation|Mean
2636379|NCT01791244|Secondary|Change From Baseline in Modified Fatigue Impact Scale Index at Month 6 and 12|The Modified Fatigue Impact Index assesses fatigue- severity, distress, or degree of interference. Modified Fatigue Impact Scale Index was expressed in terms of percentage and ranged from 0% (no fatigue) to 100% (almost always impacted by fatigue).|Baseline, Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires. Here, “Number of subjects analyzed” signifies those subjects who were evaluable for this outcome Measure.|||Percentage of fatigue||Standard Deviation|Mean
2636380|NCT01791244|Secondary|Change From Baseline in Modified Fatigue Impact Scale Score at Month 6 and 12|The Modified Fatigue Impact Scale is a list of 21 statements describing how fatigue may affect a person's functioning. Answers ranging from 0 (Never) to 4 (Almost always). A total score ranged from a possible 0 (no fatigue impact) to 84 (almost always impacted by fatigue). A lower total score indicates less fatigue-related impact while a higher total score indicates greater fatigue-related impact on a subject's functioning.|Baseline, Month 6 and 12|"ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.. Here, Overall Number of subjects analyzed signifies those subjects who were evaluable for this outcome Measure."|||units on a scale||Standard Deviation|Mean
2636381|NCT01791244|Secondary|Change From Baseline in Fatigue Severity Scale (FSS) Score at Month 6 and 12|Fatigue Severity Scale (FSS) is a method of evaluating fatigue in multiple sclerosis and is designed to differentiate fatigue from clinical depression, since both share some of the same symptoms. The Fatigue Severity Scale is a 9-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 1-7 scale (1= no fatigue and 7= severe fatigue). The total score was calculated as the average of individual 9-items and ranged from 1 to 7 with a higher value indicating greater impairment due to fatigue.|Baseline, Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.|||units on a scale||Standard Deviation|Mean
2636382|NCT01791244|Secondary|Percentage of Subjects With Treatment Adherence at Month 6 and 12|According to the World Health Organisation (WHO), treatment adherence is defined as both compliance (taking the medication in the correct dose and according to the schedule prescribed) and persistency (maintenance of the drug regimen over the long-term). Percentage of subjects with <10% missed injections (measured with the software RDS 2.0) during 6 and 12 months were reported.|Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.|||Percentage of Subjects|||Number
2636383|NCT01791244|Secondary|Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Visual Analogue Scale (VAS) Scale at Month 6 and 12|EQ-5D-5L VAS was used to record a subject's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.|Baseline, Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.|||units on a scale||Standard Deviation|Mean
2636384|NCT01791244|Secondary|Change From Baseline in Euro Quality of Life Questionnaire With 5 Questions Alternatives (EQ5D-5L) Summary Score at Month 6 and 12|Quality of life was assessed using the EQ5D-5L score, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises 5 levels with corresponding numeric scores ranging from 1 (no problems) through 5 (extreme problems) in which 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. A unique EQ5D-5L health state was defined by combining the numeric level scores for each of the 5 dimensions and the total score ranges from 5 to 25. An increase in the EQ5D-5L total score indicates worsening.|Baseline, Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.|||units on a scale||Standard Deviation|Mean
2636385|NCT01791244|Secondary|Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Total Score at Month 6 and 12|Multiple Sclerosis Impact Scale-29 (MSIS-29) is a validated MS specific questionnaire consisting of 29 questions of which 20 addressed the physical impact component and 9 assessed the psychological impact. A combined score can be generated, or both components can be reported separately. The total score of the MSIS-29 was comprised of all the 29 questions in which subjects rate the impact of MS on their day-to-day life from 1=no impact to 5=extreme impact. The total Score was calculated using following formula: sum of score for 29 questions - 29/1.45. The total score range ranges from 0-100 where, lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a subject's functioning.|Baseline, Month 6 and 12|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.|||units on a scale||Standard Deviation|Mean
2636386|NCT01791244|Secondary|Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 6|Multiple Sclerosis Impact Scale-29 (MSIS-29) is a validated MS specific questionnaire consisting of 29 questions of which 20 addressed the physical impact component and 9 assessed the psychological impact. A combined score can be generated, or both components can be reported separately. The psychological wellbeing assessment portion of the MSIS-29 was comprised of 9 questions in which subjects rate the impact of MS on their day-to-day life from 1=no impact to 5=extreme impact. The total Psychological Score was calculated using following formula: sum of score for 9 questions - 9/0.36. The total score range ranges from 0-100 where, lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a subject's functioning.|Baseline and Month 6|ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.|||units on a scale||Standard Deviation|Mean
2636387|NCT01791244|Primary|Change From Baseline in Multiple Sclerosis Impact Scale-29 (MSIS-29) Psychological Score at Month 12|Multiple Sclerosis Impact Scale-29 (MSIS-29) is a validated MS specific questionnaire consisting of 29 questions of which 20 addressed the physical impact component and 9 assessed the psychological impact. A combined score can be generated, or both components can be reported separately. The psychological wellbeing assessment portion of the MSIS-29 was comprised of 9 questions in which subjects rate the impact of MS on their day-to-day life from 1=no impact to 5=extreme impact. The total Psychological Score was calculated using following formula: sum of score for 9 questions - 9/0.36. The total score range ranges from 0-100 where, lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a subject's functioning.|Baseline and Month 12|The ITT population included all subjects randomized into the trial and have completed at least 1 post-baseline assessment of the questionnaires.|||units on a scale||Standard Deviation|Mean
2636388|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Serum Electrophoresis Parameters Over Time|Serum electrophoresis parameters includes albumin, alpha-1 globulin, alpha-2 globulin, beta globulin, gamma globulin was reported. Mean change from Baseline values are reported at each time points.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.|||Percentage of concentration||Standard Deviation|Mean
2636389|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Aspartate Transaminase, Alanine Transaminase, Gamma-glutamyl Transpeptidase, and Alkaline Phosphatase Levels Over Time|Mean change from baseline in aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transpeptidase (GGT) and alkaline phosphatase levels are reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.|||Units/Liter||Standard Deviation|Mean
2636390|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Total Cholesterol, Low-density and High-density Lipoprotein Cholesterol, Triglycerides, Total Bilirubin, Direct Bilirubin, Glucose, Creatinine, Blood Urea Nitrogen Levels Over Time|Mean change from baseline in total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides (TG), total bilirubin, direct bilirubin, glucose, creatinine, blood urea nitrogen (BUN) levels are reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.|||mg/dL||Standard Deviation|Mean
2636391|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Red Blood Cells, White Blood Cells, and Platelets Over Time|Mean change from baseline in red blood cells (RBC), white blood cells (WBC) and platelets are reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.|||10^6 cells/microliter||Standard Deviation|Mean
2636396|NCT01791205|Secondary|Phase II: Number of Participants With Retention in Therapy Without Interruption Due to Side Effects|Number of participants who retained in therapy without interruption due to side effects is reported.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Participants|||Number
2636397|NCT01791205|Secondary|Phase II: Number of Participants With Any Adverse Events, Any Serious Adverse Events, Adverse Events of Special Interest, and Tubercular Events|An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions that worsened during the study were reported as AE. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect. The AE were captured only for Phase II.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Participants|||Number
2636398|NCT01791205|Secondary|Phase II: Mean VAS Fatigue Score Overtime|The VAS fatigue score ranging from 0 (symptom-free and no arthritis symptoms) to 100 (worsening in symptoms and arthritis disease activity). Higher score indicate worsening.|At Baseline (Day of first administration of TCZ as a monotherapy) and Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.|||Scores on scale||Standard Deviation|Mean
2636399|NCT01791205|Secondary|Phase II: Percentage of Participants With Delta HAQ >= 0.21 at Months 3, 6, 12, and 18|Percentage of participants with change in HAQ (Delta HAQ) of >= 0.21 after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy are reported. The HAQ consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Percentage of participants||95% Confidence Interval|Number
2636400|NCT01791205|Secondary|Phase II: Mean Change From Baseline in Dose of Corticosteroids at Months 3, 6, 12, and 18|Mean Change From Baseline (day of the first infusion with tocilizumab as monotherapy) in the dose of corticosteroids after 3, 6, 12 and 18 months from Baseline is reported.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.|||milligrams||Standard Deviation|Mean
2636401|NCT01791205|Secondary|Phase II: Mean Change From Baseline in TJC And SJC at Months 3, 6, 12, and 18|The mean change from Baseline (day of the first infusion with tocilizumab as monotherapy) in the TJC And SJC after 3, 6, 12 and 18 months is reported. The TJC and SJC were determined for 28 joint counts. The scores ranged from 0 (no disease activity) to 28 (higher/worsen disease activity), where higher scores represents higher disease activity.|From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy. Participants with available data at specified time points are denoted as ‘n’.|||Joints||Standard Deviation|Mean
2636402|NCT01791205|Secondary|Phase II: Percentage of Participant Achieving SDAI Remission (< 3.3) at Months 3, 6, 12, and 18|Percentage of participant achieving SDAI remission (< 3.3), after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy is reported. The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA which (based on 0-10 cm VAS, 0 = no disease activity and 10 = worst disease activity, where higher scores represent higher disease activity), and CRP. The SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 = low disease activity, > 11 to 26 = moderate disease activity, and > 26 = high disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Percentage of participants||95% Confidence Interval|Number
2636403|NCT01791205|Secondary|Phase II: Percentage of Participants Achieving CDAI Remission (< 2.8) at Months 3, 6, 12, and 18|Percentage of participants achieving CDAI remission < 2.8, after 3, 6, 12 and 18 months from the first infusion with tocilizumab as monotherapy are reported. CDAI is the numerical sum of four outcome parameters: TJC, SJC based on a 28-joint assessment; and PtGA and PhGA assessed on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =< 2.8 indicates clinical remission, > 2.8 to 10 indicates low disease activity, > 10 to 22 indicates moderate disease activity, and > 22 indicates high disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Percentage of participants||95% Confidence Interval|Number
2636404|NCT01791205|Secondary|Phase II: Percentage of Participants Achieving DAS 28 ESR (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18|The DAS28 ESR is a measure of the participant's disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease. The DAS28 ESR < 2.6 indicates disease remission and >=2.6 to 3.2 indicates low disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Percentage of participants||95% Confidence Interval|Number
2636427|NCT01791205|Primary|Phase I: Number of Biologics Administered as Monotherapy in Monotherapy and Combination Therapy|Participants who received at least one previous treatment with biologics in monotherapy and no previous monotherapy with biologics are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Participants|||Number
2636405|NCT01791205|Secondary|Phase II: Percentage of Participants Achieving DAS28 CRP Remission (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18|The DAS28-CRP is a combined index that measured RA disease activity. It is calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL). It is calculated by using the formula: DAS28 CRP= 0.56 × square root of TJC (28 joints) + 0.28 square root of SJC (28 joints) + 0.36 × log n at (CRP+1) + 0.014 × PtGA + 0.96. The DAS28 CRP scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease. The DAS28 CRP < 2.6 indicates disease remission and >=2.6 to 3.2 indicates low disease activity.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Percentage of participants||95% Confidence Interval|Number
2636406|NCT01791205|Secondary|Phase II: Percentage of Participants Maintaining Delta DAS28 ESR >= 0.6 at Months 3, 6, 12, and 18|Participants who maintained delta DAS28 ESR of >= 0.6 after 3, 6, 12, and 18 months from the first infusion with tocilizumab as monotherapy are reported. The DAS28 ESR is a measure of the participant's disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); where decrease in score indicated improvement of disease.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Percentage of participants||95% Confidence Interval|Number
2636407|NCT01791205|Secondary|Phase II: Percentage of Participants Maintaining Delta DAS 28 CRP of >= 0.6 at Months 3, 6, 12, and 18|Participants who maintained the change in DAS28 (Delta DAS28) CRP of >=0.6 after 3, 6, 12, and 18 months from the first infusion with tocilizumab as monotherapy are reported. The DAS28-CRP is a combined index that measured RA disease activity. It is calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL). It is calculated by using the formula: DAS28 CRP= 0.56 × square root of TJC 28 + 0.28 square root of SJC 28 + 0.36 × log n at (CRP+1) + 0.014 × PtGA + 0.96. The DAS28 CRP- scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease.|At Months 3, 6, 12, and 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Percentage of participants||95% Confidence Interval|Number
2636408|NCT01791205|Secondary|Phase I: Mean Duration of Treatment With A Biologic Drug in Combination With DMARDs Before Monotherapy|Mean duration of treatment with a biologic drug in combination with DMARDs before monotherapy is reported in days.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants who received previous treatment with a biologic drug in combination with DMARDs before monotherapy were considered for this outcome measure.|||Days||Standard Deviation|Mean
2636409|NCT01791205|Secondary|Phase I: Mean Duration of Previous Treatment With a Biologic Drug in Monotherapy and Combination Therapy|Mean duration of previous treatment with a biologic drug in monotherapy are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants who received previous treatment with a biologic drug before monotherapy were considered for this outcome measure.|||Days||Standard Deviation|Mean
2636410|NCT01791205|Secondary|Phase I: Mean Dose of Corticosteroids At Study Entry in Monotherapy and Combination Therapy|Mean dose of corticosteroids at study entry (Baseline) is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants who received corticosteroids were considered for this outcome measure.|||milligrams||Standard Deviation|Mean
2636411|NCT01791205|Secondary|Phase I: Percentage of Participants Treated With Corticosteroids at Study Entry in Monotherapy and Combination Therapy|The percentage of participants treated with corticosteroids at enrollment is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Percentage of participants||95% Confidence Interval|Number
2636412|NCT01791205|Secondary|Phase I: Mean Tender Joints and Swollen Joints as Disease Activity at Study Entry in Monotherapy and Combination Therapy|Mean of tender and swollen joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender and swollen joints was recorded on the joint assessment as no tenderness = 0 and tenderness = 1.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available tender and swollen joints at Baseline are reported.|||Joints||Standard Deviation|Mean
2636413|NCT01791205|Secondary|Phase I: Number of Participants With SDAI Scores at Study Entry in Monotherapy and Combination Therapy|The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (assessed on 0-10 cm) VAS; 0 = no disease activity and 10 = worst disease activity), and CRP (mg/dL). SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available SDAI score at Baseline are reported.|||Participants|||Number
2636414|NCT01791205|Secondary|Phase I: Number of Participants With CDAI Scores at Study Entry in Monotherapy and Combination Therapy|The CDAI is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment; and PtGA and PhGA assessed on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =< 2.8 indicates clinical remission, > 2.8 to 10 indicates low disease activity, > 10 to 22 indicates moderate disease activity, and > 22 indicates high disease activity. Number of participants with CDAI scores for both the groups at study entry (baseline) are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available CDAI score at Baseline are reported.|||Participants|||Number
2636482|NCT01790828|Secondary|Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants <18 Years of Age||4 years|All enrolled participants; only participants <18 years who received on-demand therapy were included in the analysis.|||IU||Full Range|Median
2636415|NCT01791205|Secondary|Phase I: Median DAS28 at Study Entry in Monotherapy and Combination Therapy|The DAS28 is a combined index for measuring disease activity in RA. The index includes SJC and TJC, acute phase response, and general health status. The DAS28 scale ranges from 0 to 10 (0= no disease activity and 10= maximum disease activity) where higher scores represents higher disease. The DAS28 <2.6 indicates disease remission, >=2.6 and <3.2 indicates Low disease activity, >=3.2 and <=5.1 indicates Moderate disease activity and >5.1 indicates High disease activity. Median score for DAS28 at the study entry (Baseline) is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available DAS28 score at Baseline are reported.|||Scores on scale||Full Range|Median
2636416|NCT01791205|Secondary|Phase I: Percentage of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy|Participants who had prevalence with at least one previous switch, swaps or switch/swap to other therapy either monotherapy or combination therapy are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Percentage of participants||95% Confidence Interval|Number
2636417|NCT01791205|Secondary|Phase I: Number of Participants With at Least One Previous Treatment With Biologics Drug as a Monotherapy in Monotherapy and Combination Therapy|Number of participants who received at least one previous treatment with a biologic drug as a monotherapy in both groups is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. One participant in monotherapy group and 4 participants in combination group were not included because they had not received a previous treatment.|||Participants|||Number
2636418|NCT01791205|Secondary|Phase I: Number of Participants Receiving a Biologic Drug as Monotherapy at Different Treatment Lines|The first biologic treatment line was defined as the first use of any biologic drug in treatment of rheumatoid arthritis, regardless its association with DMARDs, the second treatment line as the subsequent use of a different biologic drug and so on for the third, fourth, fifth and sixth treatment line. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Participants|||Number
2636419|NCT01791205|Secondary|Phase I: Percentage of Participants Who Started Treatment With a Biologic Drug in Monotherapy and Percentage of Participants Who Stopped a DMARDs While Taking a Biologic Drug in Combination Therapy|The table below shows percentage participants who started treatment with a biologic drug in monotherapy compared with percentage of participants who stopped DMARDs while taking a biologic drug in combination.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. One participant in monotherapy group and 4 participants in combination group were not included because they had not received a previous treatment.|||Percentage of Participants||95% Confidence Interval|Number
2636420|NCT01791205|Secondary|Phase I: Mean Health Assessment Questionnaire-Disability Index in Monotherapy and Combination Therapy|The HAQ-DI is a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity. Participants assessed their ability to do each task over the past seven days.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Scores on scale||Standard Deviation|Mean
2636421|NCT01791205|Secondary|Phase I: Percentage of Participants With Comorbidity in Monotherapy and Combination Therapy|Comorbidity is the presence of previous or concomitant diseases. Percentage of participants with comorbidity is reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Percentage of participants|||Number
2636422|NCT01791205|Secondary|Phase I: Median Disease Duration in Monotherapy and Combination Therapy|The duration of disease is defined as the total time from the diagnosis of RA until the study entry.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Months||95% Confidence Interval|Median
2636423|NCT01791205|Primary|Phase II: Retention Rate in Therapy, Percentage of Participants Achieving DAS 28 ESR <2.6 and <3.2 at Month 18|Participants who retained the therapy were analyzed for disease activity (DAS28 ESR) at Month 18. The DAS28 ESR is a measure of the participant's disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease.|At month 18|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Percentage of participants||95% Confidence Interval|Number
2636424|NCT01791205|Primary|Phase II: Percentage of Participants Who Retained on Tocilizumab Monotherapy|The probabilities of participant to retain on therapy at various time points are reported.|Up to 18 months|Analysis population included participants who were enrolled in Phase I and received tocilizumab as monotherapy.|||Percentage of participants||95% Confidence Interval|Number
2636425|NCT01791205|Primary|Phase I: Number of Participants With Reasons Leading to the Use of Biologic in Monotherapy|Reasons leading to the use of biologic in monotherapy includes DMARDs intolerance, insufficient therapeutic effect, intolerance to biologic drug, low participant's compliance, concomitant pathologies, pregnancy desire, remission from combination therapy, remission from monotherapy, others and unknown. Participants with reason leading to the use of biologic in monotherapy are presented. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Participants|||Number
2636426|NCT01791205|Primary|Phase I: Number of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy|Participants who had prevalence with at least one previous switch, swaps, and switch/swap to other therapy are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Participants|||Number
2636428|NCT01791205|Primary|Phase I: Number of Participants Treatment Line in Which Monotherapy Has Been Adopted in Monotherapy|The first biologic treatment line was defined as the first use of any biologic drug in treatment of rheumatoid arthritis, regardless its association with DMARDs and the second treatment line as the subsequent use of a different biologic drug. Participants who adopted monotherapy as =< 2 and > 2 therapy lines are reported. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Participants|||Number
2636429|NCT01791205|Primary|Phase I: Number of Participants With Duration of Combination Therapy Before Monotherapy in Monotherapy and Combination Therapy|The duration of combination therapy before monotherapy are reported. The duration was estimated by calculating total duration from starting the combination therapy till the participant switched to monotherapy. Participants who started the combination therapy and later switched to monotherapy =< 337 days, > 337 days, =< 336 days, > 336 days are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at specified time points are denoted as ‘n’.|||Participants|||Number
2636430|NCT01791205|Primary|Phase I: Number of Participants With Simplified Disease Activity Index in Monotherapy and Combination Therapy|The disease activity included Simplified Disease Activity Index (SDAI) which is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =< 3.3 indicates disease remission, > 3.4 to 11 indicates low disease activity, > 11 to 26 indicates moderate disease activity, and > 26 indicates high disease activity. Participants with SDAI score =< 8.17 and > 8.17 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at Baseline are reported.|||Participants|||Number
2636431|NCT01791205|Primary|Phase I: Number of Participants With Clinical Disease Activity Index in Monotherapy and Combination Therapy|The disease activity included Clinical Disease Activity Index (CDAI) which is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment; and patient's global assessment (PtGA) and physician's global assessment (PhGA) assessed on 0-10 cm visual analog scale (VAS), where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =< 2.8 indicates clinical remission, > 2.8 to 10 indicates low disease activity, > 10 to 22 indicates moderate disease activity, and > 22 indicates high disease activity. Participants with CDAI score =< 7.75 and > 7.75 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at Baseline are reported.|||Participants|||Number
2636432|NCT01791205|Primary|Phase I: Number of Participants With C-Reactive Protein Value and Erythrocyte Sedimentation Rate in Monotherapy and Combination Therapy|The disease activity included biological markers of inflammation: C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR). A reduction in CRP and ESR values indicates improvement. Participants with CRP values =< 0.28 and >2.8 milligram/deciliter (mg/dL); and ESR values =< 11 and >11 millimeters/hour (mm/hr) are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at Baseline are reported. Participants with available data at specified time points are denoted as ‘n’.|||Participants|||Number
2636433|NCT01791205|Primary|Phase I: Number of Participants With Disease Activity Score 28 in Monotherapy and Combination Therapy|The disease activity included Disease Activity Score 28 (DAS28). The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen joint counts (SJC) and tender joint counts (TJC), acute phase response, and general health status. The DAS28 scale ranges from 0 to 10 (0= no disease activity and 10= maximum disease activity; where higher scores represents higher disease activity. The DAS =< 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity. Participants with DAS28 score =< 2.6 and > 2.6 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at Baseline are reported.|||Participants|||Number
2636434|NCT01791205|Primary|Phase I: Number of Participants With Health Assessment Questionnaire- Disability Index in Monotherapy and Combination Therapy|The Health Assessment Questionnaire- Disability Index (HAQ-DI) is a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity. Participants assessed their ability to do each task over the past seven days. Participants with scores =< 0.8625 and > 0.8625 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at the time of evaluation are reported.|||Participants|||Number
2636435|NCT01791205|Primary|Phase I: Number of Participants With Autoantibody Status (Rheumatoid Factor and Anti-cyclic Citrullinated Protein Antibodies) in Monotherapy and Combination Therapy|The autoantibody included seropositive or seronegative participants for rheumatoid factor (RF) and/or anti-cyclic citrullinated protein antibodies (Anti-CCP). RF value higher than 20 Units (U)/milliliter (mL) is considered seropositive and anti-CCP antibodies value higher than 10 U/mL is considered positive.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at specified time points are denoted as ‘n’.|||Participants|||Number
2636436|NCT01791205|Primary|Phase I: Number of Participants With Comorbidity in Monotherapy and Combination Therapy|Comorbidity is the presence of previous or concomitant diseases.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Participants|||Number
2636483|NCT01790828|Secondary|Average Infusion Dose Per Bleeding for On-Demand Therapy (All Participants)||4 years|All enrolled participants; only participants who received on-demand therapy were included in the analysis.|||IU||Standard Deviation|Mean
2636437|NCT01791205|Primary|Phase I: Number of Participants With Disease Duration in Monotherapy and Combination Therapy|The duration of disease is defined as the total time from the diagnosis of rheumatoid arthritis (RA) until the study entry.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants.|||Participants|||Number
2636438|NCT01791205|Primary|Phase I: Number of Participants With Demographic Characteristics in Monotherapy and Combination Therapy|Demographic characteristics were analyzed in participants at Baseline, where Baseline is considered as the study entry visit (day of informed consent form signed). Demographic characteristics which were taken into account included age in years, race, height in centimeters (cm), weight in Kilograms (Kg), and Body Mass Index (BMI) in Kg/cm^2. Participants with age =<, > 59 years, height =<, > 163 cm, weight =<, > 65.85 Kg and BMI =<, > 24.98 Kg/cm^2 are reported.|At Baseline (Day of informed consent form signed)|Analysis population included all enrolled participants. Participants with available data at specified time points are denoted as ‘n’.|||Participants|||Number
2636439|NCT01791153|Secondary|Percentage of Participants With Anti-Tocilizumab Antibodies|All samples were tested by screening assay, and those samples that were positive were further analyzed by a confirmation assay to confirm specificity. Percentage of participants who has a positive confirmation assay result any time after the initial drug administration with a negative confirmation assay result at baseline was reported.|Baseline up to Week 52|Safety population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants|||Number
2636440|NCT01791153|Secondary|C-Reactive Protein (CRP) Level|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline and Week 52|Safety population. Here, 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.|||milligrams per liter (mg/L)||Inter-Quartile Range|Median
2636441|NCT01791153|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Baseline and Week 52|Safety population. Here, 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.|||mm/hr||Inter-Quartile Range|Median
2636442|NCT01791153|Secondary|Serum Soluble IL-6 Receptor (sIL-6R) Level||Baseline and Week 52|Safety population. Here, 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2636443|NCT01791153|Secondary|Serum Interleukin-6 (IL-6) Level||Baseline and Week 52|Safety population. Here, 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
2636444|NCT01791153|Secondary|Minimum Observed Serum Concentration (Ctrough) of Tocilizumab|Ctrough is minimum observed serum concentration of tocilizumab measured in mcg/mL.|Predose (Hour 0) at Baseline and Week 52|PK-evaluable population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.|||mcg/mL||Standard Deviation|Mean
2636445|NCT01791153|Secondary|Minimum Serum Concentration at Steady State (Cmin,ss) of Tocilizumab|Cmin,ss is minimum model-predicted serum steady state concentration of tocilizumab measured in mcg/mL.|Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])|PK-evaluable population|||mcg/mL||Standard Deviation|Mean
2636446|NCT01791153|Secondary|Maximum Serum Concentration at Steady State (Cmax,ss) of Tocilizumab|Cmax,ss is maximum model-predicted serum steady state concentration of tocilizumab measured in micrograms per milliliter (mcg/mL).|Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])|PK-evaluable population|||mcg/mL||Standard Deviation|Mean
2636447|NCT01791153|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Steady State of Tocilizumab|AUCtau is the model-predicted area under the tocilizumab serum concentration versus time curve from time zero to the end of dosing interval. AUCtau is measured in microgram*day per milliliter (mcg*day/mL).|Baseline and Week 16 (Predose [Hour 0], 24, 48, 72, 96, and 120 or 144 hours postdose); Weeks 1, 2, 17, and 18 (Predose [Hour 0])|Pharmacokinetics (PK)-evaluable population included all participants who received at least one tocilizumab injection and had at least one PK sample with detectable results taken at any time during the study.|||mcg*day/mL||Standard Deviation|Mean
2636448|NCT01791153|Secondary|Change From Baseline in Patient Global Assessment (PGA) of Disease Activity Assessed Using Visual Analogue Scale (VAS) at Week 52|Participants assessed their current disease activity on a 0-100 millimeter (mm) VAS, where 0 mm = no disease activity and 100 mm = maximum disease activity. A negative change from baseline indicates improvement.|Baseline, Week 52|ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.|||mm||Standard Deviation|Mean
2636449|NCT01791153|Secondary|Change From Baseline in Short Form (SF)-36 Questionnaire Score at Week 52|The SF-36 is a standardized questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical Component Score (PCS) and Mental Component Score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). A positive change from baseline indicates improvement. No imputation was used for missing data. Data was set to missing for participants who received escape therapy.|Baseline, Week 52|ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point for different arms, respectively.|||units on a scale||Standard Deviation|Mean
2636450|NCT01791153|Secondary|Total Cumulative Prednisone Dose|The median total cumulative prednisone dose over the 52 weeks for each treatment group and the corresponding 95% confidence intervals are presented.|Up to 52 weeks|ITT Population|||milligrams (mg)||95% Confidence Interval|Median
2636451|NCT01791153|Secondary|Time to First GCA Disease Flare|Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or ESR >/=30 mm/hr attributable to GCA. Participants who withdrew from the study prior to Week 52 were censored from the time of withdrawal.|Up to 52 weeks|ITT population|||days||99% Confidence Interval|Median
2636452|NCT01791153|Secondary|Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 52 Weeks Prednisone Taper)|Remission was defined as the absence of flare and normalization of the CRP (<1 mg/dL). Sustained remission was defined as the absence of flare following induction of remission within 12 weeks of randomization and maintained up to Week 52. Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or ESR >/=30 mm/hr attributable to GCA. A single CRP elevation (>/=1 mg/dL) was not considered as a sign of flare, unless the CRP remained elevated (>/=1 mg/dL) at the next study visit.|Week 52|ITT population|||percentage of participants|||Number
2636453|NCT01791153|Primary|Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper)|Remission was defined as the absence of flare and normalization of the C-reactive protein (CRP) (less than [<] 1 milligram per deciliter [mg/dL]). Sustained remission was defined as the absence of flare following induction of remission within 12 weeks of randomization and maintained up to Week 52. Flare was determined by the investigator and was defined as the recurrence of signs or symptoms of GCA and/or erythrocyte sedimentation rate (ESR) greater than or equal to (>/=) 30 millimeters per hour (mm/hr) attributable to GCA. A single CRP elevation (>/=1 mg/dL) was not considered as a sign of flare, unless the CRP remained elevated (>/=1 mg/dL) at the next study visit.|Week 52|Intent-to-treat (ITT) population included all participants randomized into the study who received at least one administration of study drug.|||percentage of participants|||Number
2636454|NCT01791127|Secondary|Impedance Measurements for Siello S Leads Through 5 Years|Impedance measurements for Siello S leads implanted in the atrium or ventricle through the 5 year follow-up visit.|5-years|All originally implanted ventricular or atrial Siello leads with implant and follow-up data entered into the EDC on or before April 17, 2019 are included in this analysis.|||Ohms||Standard Deviation|Mean
2636455|NCT01791127|Secondary|Sensing Measurements for Siello S Leads Through 5 Years|Sensing measurements for Siello S leads implanted in the atrium or ventricle through the 5 year follow-up visit.|5-years|All originally implanted ventricular or atrial Siello leads with implant and follow-up data entered into the EDC on or before April 17, 2019 are included in this analysis.|||mV||Standard Deviation|Mean
2636456|NCT01791127|Secondary|Pacing Threshold Measurements for Siello S Leads Through 5 Years|Pacing threshold measurements for Siello S leads implanted in the atrium or ventricle through 5 years of follow-up.|5-years|All originally implanted ventricular or atrial Siello leads with implant and follow-up data entered into the EDC on or before April 17, 2019 are included in this analysis.|||volts||Standard Deviation|Mean
2636457|NCT01791127|Secondary|Siello S Lead Effectiveness at 5 Years|Success rate of the implanted system to deliver long-term pacing at 5-years post-implant.|5-years|On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing SIELLO Post Approval Registry to a new EP PASSION real-world data methodology. Therefore, this outcome measure was not completed.||||||
2636458|NCT01791127|Secondary|Incidence of All Other Adverse Events|The overall incidence of all other adverse events that were excluded from primary and secondary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR).|5-years|On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing SIELLO Post Approval Registry to a new EP PASSION real-world data methodology. Therefore, this outcome measure was not completed.||||||
2636459|NCT01791127|Secondary|Impedance Measurements for Siello S Leads at 12 Months|Impedance measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.|12-months|All originally implanted ventricular or atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis.|||Ohms||Standard Deviation|Mean
2636460|NCT01791127|Secondary|Sensing Measurements for Siello S Leads at 12 Months|Sensing measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.|12-months|All originally implanted ventricular or atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis.|||mV||Standard Deviation|Mean
2636461|NCT01791127|Secondary|Pacing Threshold Measurements for Siello S Leads at 12 Months|Pacing threshold measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.|12-months|All originally implanted ventricular or atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis.|||volts||Standard Deviation|Mean
2636462|NCT01791127|Secondary|Atrial Siello S Lead Safety at 5 Years - Individual Adverse Event Rates|Evaluation of the individual adverse events contributing to the outcome measure 'Atrial Siello S Lead Safety at 5 Years'.|5-years|On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing SIELLO Post Approval Registry to a new EP PASSION real-world data methodology. Therefore, this outcome measure was not completed.||||||
2636463|NCT01791127|Secondary|Atrial Siello S Lead Safety at 5 Years|The overall incidence of adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the atrium with a BIOTRONIK Evia pacemaker device through 5 years follow-up. This was evaluated as an adverse event free-rate (AEFR).|5-years|On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing SIELLO Post Approval Registry to a new EP PASSION real-world data methodology. Therefore, this outcome measure was not completed.||||||
2636464|NCT01791127|Primary|Ventricular Siello S Lead Safety at 5 Years - Individual Adverse Event Rates|Evaluation of the individual adverse events contributing to the outcome measure 'Ventricular Siello S Lead Safety at 5 Years'.|5-years|On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing SIELLO Post Approval Registry to a new EP PASSION real-world data methodology. Therefore, this outcome measure was not completed.||||||
2636465|NCT01791127|Primary|Ventricular Siello S Lead Safety at 5 Years|The overall incidence of adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the ventricle with a BIOTRONIK Evia pacemaker device through 5 years follow-up. This was evaluated as an adverse event free-rate (AEFR).|5-Years|On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing SIELLO Post Approval Registry to a new EP PASSION real-world data methodology. Therefore, this outcome measure was not completed.||||||
2636466|NCT01791127|Primary|Siello S Lead Effectiveness at 12 Months|Success rate of the implanted system to sense and deliver pacing at 12-months post implant.|12-months|The Pre-Market cohort was defined as the population of subjects who were implanted (or had an implant attempt) of one or more Siello leads on or before the implant date of the last subject to reach the 12-month follow-up time point as of April 3, 2015 and/or experienced a qualifying event.|||percentage of participants||95% Confidence Interval|Number
2636467|NCT01791127|Primary|Ventricular Siello S Lead Safety at 12 Months|The overall incidence of adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the ventricle with a BIOTRONIK Evia pacemaker device through 12 months follow-up. This was evaluated as an adverse event free-rate (AEFR).|12-month|The Pre-Market cohort was defined as the population of subjects who were implanted (or had an implant attempt) of a ventricular Siello lead on or before the implant date of the last subject to reach the 12-month follow-up time point as of April 3, 2015 and/or experienced a qualifying event.|||percentage of participants||95% Confidence Interval|Number
2636468|NCT01791127|Primary|Atrial Siello S Lead Safety at 12 Months|The overall incidence of adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the atrium with a BIOTRONIK Evia pacemaker device through 12 months follow-up. This was evaluated as an adverse event free-rate (AEFR).|12 month|The Pre-Market cohort was defined as the population of subjects who were implanted (or had an implant attempt) of an atrial Siello lead on or before the implant date of the last subject to reach the 12-month follow-up time point as of April 3, 2015 and/or experienced a qualifying event.|||percentage of participants||95% Confidence Interval|Number
2636469|NCT01790932|Secondary|Overall Survival|Overall survival (OS) is defined as the duration of time from study entry to death or date last known alive and estimated using the KM method.|Participants were assessed every 3 months post-treatment up to 2 years. Average survival follow-up for the study cohort was 13.8 months.|The analysis dataset is comprised of all enrolled participants.|||months||95% Confidence Interval|Median
2636470|NCT01790932|Secondary|Progression Free Survival|Progression-free survival (PFS) based on the Kaplan-Meier (KM) method is defined as the duration of time from study entry to documented disease progression (PD) or death. Participants alive without PD are censored at the date of last disease assessment. Per RECIST 1.1 criteria: PD is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment then every 3 months up to 2 years. Participants in this study cohort were followed for PFS on average approximately 2 months.|The analysis dataset is comprised of all enrolled participants.|||months||95% Confidence Interval|Median
2636471|NCT01790932|Primary|Clinical Benefit Rate|Clinical benefit rate (CBR) was defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) for 4 months or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria.|Disease was evaluated radiologically at baseline and every 2 cycles on treatment then every 3 months up to 2 years. Participants in this study cohort were followed for response on average approximately 2 months.|The analysis dataset is comprised of all enrolled participants.|||proportion of participants||95% Confidence Interval|Number
2636472|NCT01790828|Secondary|Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants ≥18 Years of Age||4 years|All enrolled participants; only participants ≥18 years were included in the analysis; participants were excluded from the analysis if total number of infusions for prophylaxis was unknown.|||IU||Standard Deviation|Mean
2636473|NCT01790828|Secondary|Total Factor Consumption for On-Demand Therapy and During Prophylaxis in Participants <18 Years of Age||4 years|All enrolled participants; only participants <18 years were included in the analysis and participants were excluded from the analysis if total number of infusions for prophylaxis was unknown.|||IU||Full Range|Median
2636474|NCT01790828|Secondary|Total Factor Consumption for On-Demand Therapy and During Prophylaxis (All Participants)||4 years|All enrolled participants; participants were excluded from the analysis if total number of infusions for prophylaxis was unknown.|||IU||Standard Deviation|Mean
2636475|NCT01790828|Secondary|Average Infusion Dose During Prophylaxis in Participants ≥18 Years of Age||4 years|All enrolled participants; only participants ≥18 years with nonmissing data were included in the analysis.|||IU||Standard Deviation|Mean
2636476|NCT01790828|Secondary|Average Infusion Dose During Prophylaxis in Participants <18 Years of Age||4 years|All enrolled participants; only participants <18 years were included in the analysis.|||IU||Standard Deviation|Mean
2636477|NCT01790828|Secondary|Average Infusion Dose During Prophylaxis (All Participants)||4 years|All enrolled participants; only participants with nonmissing data were included in the analysis.|||IU||Standard Deviation|Mean
2636478|NCT01790828|Secondary|Number of Participants With LETE Bleeds Within 48 Hours of a Preventive/Prophylaxis Dose of Xyntha|Less than expected therapeutic effect for prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleed wtihin 48 hours of prophylaxis infusion.|4 years|Data were not analyzed as information on breakthrough bleeds within 48 hours was not collected.||||||
2636479|NCT01790828|Secondary|Annualized Bleeding Rates During Prophylaxis|Annualized bleeding rate defined as total number of breakthrough bleeds within 48 hours (for prophylaxis purpose) divided by (/) [(total period of date of bleeding)/365.25)]|4 years|Data were not analyzed as information on breakthrough bleeds within 48 hours was not collected.||||||
2636480|NCT01790828|Secondary|Percentage of Participants Experiencing Hemorrhages During Prophylaxis||4 years|All enrolled participants; n (number) equals (=) number of participants with nonmissing values|||percentage of participants|||Number
2636481|NCT01790828|Secondary|Average Infusion Dose Per Bleeding for On-Demand Therapy in Participants ≥18 Years of Age||4 years|All enrolled participants; only participants ≥18 years who received on-demand therapy were included in the analysis.|||IU||Standard Deviation|Mean
2636484|NCT01790828|Secondary|Number of Participants With Less-Than-Expected Therapeutic Effect (LETE) for On-Demand Therapy|Less than expected therapeutic effect was defined as a 'no response' rating after each of two successive infusions less than or equl to (≤) 24 hours of on-demand therapy.|4 years|Data were not analyzed as no participants experienced rating of 'no response'.||||||
2636485|NCT01790828|Secondary|Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants ≥18 Years of Age|Response categories were excellent, good, moderate, and no response.|4 years|All enrolled participants; only participants ≥18 years who receive don-demand therapy were included in the analysis.|||number of responses|Participants||Number
2636486|NCT01790828|Secondary|Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy in Participants <18 Years of Age|Response categories were excellent, good, moderate, or no response.|4 years|All enrolled participants; only participants <18 years who received on-demand therapy were included in the analysis.|||number of responses|Participants||Number
2636487|NCT01790828|Secondary|Number of Responses by Type of Response for All Xyntha Infusions for Treatment of a Bleed for On-Demand Therapy (All Participants)|Response categories were excellent, good, moderate, or no response.|4 years|All enrolled participants; only participants who received on-demand therapy were included in the analysis.|||Number of responses|Participants||Number
2636488|NCT01790828|Secondary|Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Greater Than or Equal to (≥) 18 Years of Age||4 years|All enrolled participants; participants aged ≥18 years who received on-demand therapy were included in the analysis.|||infusions||Standard Deviation|Mean
2636489|NCT01790828|Secondary|Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy in Participants Less Than (<)18 Years of Age||4 years|All enrolled participants; only participants aged <18 years who received on-demand therapy were included in the analysis.|||infusions||Standard Deviation|Mean
2636490|NCT01790828|Secondary|Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy (All Participants)||4 years|All enrolled participants; only participants who received on-demand therapy were included in the analysis.|||infusions||Standard Deviation|Mean
2636491|NCT01790828|Primary|Percentage of Participants by Family History of Factor VIII Inhibitor||4 years|All enrolled participants.|||percentage of participants|||Number
2636492|NCT01790750|Primary|False Negative Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES)|Evaluate the usefulness of the currently FDA approved Pocket Echocardiography System (PES) in PDA detection as compared to Full Featured Echo System (FFES) by looking at false negatives between the two systems.|at baseline||||percentage of false negative||Standard Deviation|Mean
2636493|NCT01790750|Primary|False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES)|Evaluate the usefulness of the currently FDA approved Pocket Echocardiography System (PES) in PDA detection as compared to Full Featured Echo System (FFES) by looking at false positives between the two systems.|at baseline||||percentage of false positives||Standard Deviation|Mean
2636494|NCT01790685|Primary|Number of Participants Who Had a >30% Decrease in the Aqueous Levels of Various Vasoactive Proteins 4 Weeks After an Injection of Ozurdex|Vasoactive protein arrays and Enzyme linked immunosorbent assays were done for patients at baseline and week 4 visit to measure the levels of various pro-permeability factors including VEGF, SDF-1 and Angiopoietin-2.|4 months|All enrolled (23 CRVO and 17 BRVO) patients completed the study. All patients were injected with Ozurdex, however microarrays were run on only 11 CRVO and 17 BRVO patient samples. Microarray data from 11 CRVO and 11 BRVO patients was analyzed.|||participants|||Number
2636495|NCT01790659|Secondary|Median Time to Initial Clinical Cure for Index Lesions|Median time to initial clinical cure for index lesions (100% re-epithelialization of the index lesion)|When 100% re-epithelialization of the index lesion is observed at any visit Study Days (20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days|MITT subjects|||Days||95% Confidence Interval|Median
2636496|NCT01790659|Secondary|Area of Ulceration (mm^2) All Treated Lesions at Each Measurement Time Point|Area of ulceration (mm^2) of all treated lesions from baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days for mITT subjects. Data presented is as presented in the Final Clinical Study Report; any inconsistencies can't be changed.|baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days|All lesions for mITT Subjects|||mm^2|Number of lesions|Standard Deviation|Mean
2636497|NCT01790659|Secondary|Area of Ulceration (mm^2) of the Index Lesion at Each Measurement Time Point|Area of ulceration (mm^2) of the index lesion at each measurement time point for mITT subjects|baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days|mITT subjects|||mm^2||Standard Deviation|Mean
2636498|NCT01790659|Secondary|Percentage of All Lesions Cured at Day 168 (Ignores Per Subject Cure Rate)|Percentage of all lesions meeting criteria for clinical cure during the study at 168 day mark for mITT subjects|Day 168|Cure rates of all lesions over time without regard to subject for mITT subjects|||percentage of lesions|||Number
2636499|NCT01790659|Secondary|Percentage of Subjects With All Lesions Cured|• Percentage of subjects with all lesions cured, defined as: Final clinical cure as defined in primary objective (which is based solely on the index lesion); AND, Cure of all other lesions by nominal Day 100 (100% re-epithelialization of all ulcerated lesions and resolution of all other types of lesions)|100 ± 14 days|MITT subjects|||percentage of participants|||Number
2636500|NCT01790659|Primary|Percent of Participants With Final Clinical Cure|"The primary efficacy endpoint is percent of subjects with final clinical cure. Final clinical cure is defined as follows:~Subject has initial clinical cure (100% re-epithelialization of index lesion by nominal Day 63); OR,~Subject has initial clinical improvement (> 50% re-epithelialization of index lesion by nominal Day 63) followed by 100% re-epithelialization of the index lesion on or before nominal Day 100; AND,~Subject has no relapse of index lesion."|baseline (before the start of treatment), and on Study Days 20, 35 ± 2 days, 49 ± 4 days, 63 ± 7 days, 100 ± 14 days, and 168 ± 14 days|MITT subjects|||percent of participants|||Number
2641459|NCT01745913|Secondary|Transplant-related Mortality (TRM), Relapse Rate, Survival and Progression Free Survival||estimation of 24 months to obtain survival info between subjects|Data were not collected||||||
2636501|NCT01790633|Other Pre-specified|Proportion of Rapid Test Failures|The number of rapid tests giving inconclusive results divided by the total number of rapid tests (only available in the rapid test arm).|At testing|Only patients randomized to the rapid testing arm.|||proportion of participants|||Number
2636502|NCT01790633|Other Pre-specified|Proportion Participating|The number of individuals accepting to participate in the study divided by the total number of individuals proposed.|At testing||||proportion of participants|||Number
2636503|NCT01790633|Secondary|Access to Care|The number of individuals seeking specialized care with a complete evaluation of disease severity divided by the total number of seropositive individuals.|Evaluated once, up to 4 months after testing|Analysis includes only participants with positive HIV, HBV, and/or HCV results.|||proportion of participants|||Number
2636504|NCT01790633|Primary|Accessibility of Testing Results|The number of individuals who obtained test results for HBV, HCV, and/or HIV divided by the total number of tested individuals.|Evaluated once, up to 4 months after testing||||proportion of participants|||Number
2636505|NCT01790594|Secondary|Count of Participants Diagnosed With Malignancy as an Adverse Event|An increased risk/incidence of malignancy is a recognized complication of immunosuppression in recipients of organ transplants. In Phase 3 clinical trials, overall malignancy rates were similar across all treatment groups, with the exception of posttransplant lymphoproliferative disease (PTLD).Displayed are counts of all participants who experienced malignancy reported as an adverse event.|Transplant through Week 52 Post-Transplant|Intent-to-treat population|||Participants|||Count of Participants
2636506|NCT01790594|Secondary|Count of Participants Diagnosed With Epstein-Barr Virus (EBV) Infection as an Adverse Event|Viral infections following renal transplantation is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during this study using participant blood samples. Displayed are counts of all participants diagnosed with EBV infection as an adverse event by EBV test(s), diagnosed by test results from the local clinical pathology laboratory.|Transplant through Week 52 Post-Transplant|Intent-to-treat population|||Participants|||Count of Participants
2636507|NCT01790594|Secondary|Count of Participant Diagnosed With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia As Adverse Events|"Viral infections following renal transplantation is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss.~Specific viruses were monitored during this study using participant blood samples. Displayed are counts of participants who experienced BKV and CMV viremia as adverse events, diagnosed by test results from the local clinical pathology laboratory."|Transplant through Week 52 Post-Transplant|Intent-to-treat population|||Count of Participants|||Number
2636508|NCT01790594|Secondary|Count of Participants With an Infectious Disease Serious Adverse Event(s) Requiring Hospitalization or Systemic Therapy|Infections were required to be reported as a serious adverse event if they required either inpatient hospitalization or prolongation of a current hospitalization. Displayed are counts of all participants who experienced infection(s) as an adverse event, by treatment group.|Transplant through Week 52 Post-Transplant|Intent-to-treat population|||Participants|||Count of Participants
2636509|NCT01790594|Secondary|Count of Participants With the Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs)|"Adverse events were collected systematically. Counts of all participants who experienced at least one adverse event (AEs, SAEs) by assigned treatment group.~Refer to the Serious Adverse Events and Other Adverse Events tables for more detail."|From Enrollment (Pre-Transplant) to Week 52 Post-Transplant|Intent-to-treat population|||Count of Participants|||Number
2636510|NCT01790594|Secondary|Count of Participants With Event of Death, Graft Loss, or Undetectable C-peptide|"This measure counts death, graft loss, or undetectable C-peptide value (e.g., C-peptide <0.3 ng/mL) occurring at any point post-transplant and independent of each other.~Kidney Graft Loss was defined as 90 consecutive days of dialysis dependency.~Pancreas graft loss was defined as returning to exogenous insulin therapy or initiation of oral hypoglycemic agents for greater than 30 days.~Factitious hypoglycemia due to surreptitious insulin administration results in elevated serum insulin levels and low or undetectable C-peptide levels."|Transplant through Week 52 Post-Transplant|Intent-to-treat population with available data.|||Participants|||Count of Participants
2636511|NCT01790594|Secondary|Type of Treatment(s) Participants Received for Biopsy-Proven Pancreatic Allograft Rejection During the First 52 Weeks Post-Transplant|"Participants are stratified by kidney biopsy results/treatment received.~Upon having a for-cause biopsy performed, persons often receive treatment for rejection based on the biopsy results, which may or may not reveal signs of rejection. Details of biopsy findings and corresponding treatment are provided for each instance of treatment for rejection.~Results summary format: biopsy results; treatment.~Acronyms and abbreviations:~ACR=Acute Cellular Rejection~IFTA=Interstitial Fibrosis and Tubular Atrophy~ATG=Anti-thymocyte globulin therapy~IVIG=Intravenous Immunoglobulin therapy~Gd =Grade~PO=Orally~QD=Daily"|Transplant through Week 52|Intent-to-treat population with available data. Only ‘for cause’ biopsies were performed post-transplant.|||Participants|||Count of Participants
2636512|NCT01790594|Secondary|Type of Treatment(s) Participants Received for Biopsy-Proven Renal Allograft Rejection During the First 52 Weeks Post-Transplant|"Participants are stratified by kidney biopsy results/treatment received.~In the event of a for cause renal (kidney) biopsy:~-The diagnosis of acute cellular rejection (ACR) using the Banff 2007 renal allograft pathology criteria. These criteria for renal allograft biopsies is an international histopathological classification standard. ACR is defined by a renal biopsy demonstrating a Banff 2007 classification of Grade IA or greater, with higher scores indicating more severe rejection. (Ref: Solez K, Colvin RB et al. Banff 07 classification of renal allograft pathology: updates and future directions. Am J Transplant 2008 8(4): 753-60).~Acronyms and abbreviations:~ACR=Acute Cellular Rejection*~Normal*~Borderline* (criteria for ACR not fulfilled)~Gd.=Grade*~IFTA=Interstitial Fibrosis and Tubular Atrophy*~ATG=Anti-thymocyte globulin therapy~IVIG=Intravenous Immunoglobulin therapy~PO=Orally~QD=Daily *Banff 2007 renal allograft pathology criteria"|Transplant through Week 52|Intent-to-treat population with available data. All participants were considered evaluable for rejection. Only ‘for cause’ biopsies were performed post-transplant.|||Participants|||Count of Participants
2636587|NCT01790295|Secondary|Number of Participants With Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|1-year post transplant||||Participants|||Count of Participants
2636513|NCT01790594|Secondary|Count of Participants With De Novo Anti-Donor Antibodies or Anti-Human Leukocyte Antigen (HLA) Antibodies During the First 52 Weeks Post-Transplant|"The de novo development of donor-specific antibody (DSA) is associated with an increased risk of graft rejection.~The presence of anti-Histocompatibility Antigen (HLA) antibodies (alloantibodies) is associated with increased risk of acute and chronic injury to the transplant allograft."|Transplant through Week 52|Intent-to-treat population with available data|||Count of Participants|||Number
2636514|NCT01790594|Secondary|Count of Participants With Biopsy-Proven Humoral Rejection During the First 52 Weeks Post-Transplant|"Humoral rejection (i.e., antibody mediated rejection) of:~the kidney as defined by diffusely positive staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury determined by local pathology and,~the pancreas as defined by the presence of circulating anti-donor antibodies, and histopathological data including morphologic evidence of microvascular tissue injury and C4d staining in interacinar capillaries determined by local pathology."|Transplant through Week 52|Intent-to-treat population with available data|||Count of Participants|||Number
2636515|NCT01790594|Secondary|Severity Grade of First Biopsy-Proven Acute Rejection (AR) During the First 52 Weeks Post-Transplant|"AR grading using standard Banff* criteria. For both kidney and pancreas, AR is defined as a grade ≥1.~AR for the kidney: Banff 2007 criteria. Severity of AR is graded by as IA, IB, IIA, IIB, or III, with IA defined as the mildest form of AR and III being the most severe.~AR for the pancreas: Banff 2011 Criteria. Severity of AR is graded is I, II, or III, with I defined as the mildest form of AR and III being the most severe."|Transplant through Week 52|Intent-to-treat population|||Participants|||Number
2636516|NCT01790594|Secondary|Count of Participants With Acute Rejection (AR) of Kidney or Pancreatic Transplant During the First 52 Wks Post-Transplant|"Biopsy-proven acute rejection (AR) of the kidney (renal) or pancreas during the first 52 weeks post-transplant. AR grading using standard Banff* criteria. For both kidney and pancreas, AR is defined as a grade ≥1.~AR for the kidney: Banff 2007 criteria. Severity of AR is graded by as IA, IB, IIA, IIB, or III, with IA defined as the mildest form of AR and III being the most severe.~AR for the pancreas: Banff 2011 Criteria. Severity of AR is graded as I, II, or III, with I defined as the mildest form of AR and III being the most severe."|Transplant through Week 52|Intent-to-treat population|||Count of Participants|||Number
2636517|NCT01790594|Secondary|Count of Participants With Use of Lipid Lowering Medications at Baseline, Wk 28 and Wk 52 Post-Transplant|Lipid lowering medications are used in the treatment of high levels of fats (lipids), such as cholesterol in blood|Baseline (Pre-Transplant), Week 28, and Week 52|Intent-to-treat population|||participants|||Number
2636518|NCT01790594|Secondary|Lipid Profile at Wk 52 Post-Transplant|"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:~Total cholesterol: 75-169 mg/dL if age ≤ 20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease."|Week 52 Post-Transplant|Intent-to-treat population with available data|||mg/dL||Standard Deviation|Mean
2636519|NCT01790594|Secondary|Fasting Lipid Profile at Wk 28 Post-Transplant|"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:~Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease."|Week 28 Post-Transplant|Intent-to-treat population with available data|||mg/dL||Standard Deviation|Mean
2636520|NCT01790594|Secondary|Fasting Lipid Profile at Baseline (Pre-Transplant)|"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are provided:~Total cholesterol: 75-169 mg/dL if age ≤20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease and~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease."|Baseline (Pre-Transplant)|Intent-to-treat population with available data|||mg/dL||Standard Deviation|Mean
2636521|NCT01790594|Secondary|Count of Participants With Use of Anti-hypertensive Medication From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant|Anti-hypertensive medications are a class of drugs that are used to treat hypertension. The medications seek to prevent the complications of high blood pressure, such as stoke and myocardial infarction.|Baseline (Pre-Transplant) and Days 28, 84, and Weeks 28, 36, and 52|Intent-to-treat population with available data|||Count of Participants|||Number
2636534|NCT01790594|Secondary|Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant|"eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):~A score of ≥90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate very severe or end stage kidney failure."|Week 52 Post-Transplant|Intent-to-treat population|||Participants|||Count of Participants
2636522|NCT01790594|Secondary|Standardized Blood Pressure Measurement From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant|"A blood pressure measurement consists of two numbers: the systolic and diastolic pressures. Systolic pressure measures the pressure in blood vessels when the heart beats. Diastolic pressure measures the pressure in blood vessels between beats of the heart.~Systolic measures of <120 and diastolic measures of <80 are considered normal.~Systolic measures of 120-139 and diastolic measures of 80-89 are considered at risk (or pre-hypertension).~Systolic measures of ≥140 and diastolic measures of ≥90 are considered high."|Baseline (Pre-Transplant) and Days 28, 84, and Weeks 28, 36, and 52|Intent-to-treat population with available data|||mmHg||Standard Deviation|Mean
2636523|NCT01790594|Secondary|Fasting Blood Sugar (FBS) From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant|"Fasting blood sugar (e.g., glucose) test is used to help diagnose diabetes, prediabetes, and gestational diabetes.~Reference fasting blood sugar (glucose) values:~70 to 99 mg/dL is normal~100 to 125 mg/dL is considered prediabetes~126 mg/dL or higher on two separate tests is considered diabetes."|Baseline (Pre-Transplant) and Days 28, 84, and Weeks 28, 36, and 52|Intent-to-treat population with available data|||mg/dL||Standard Deviation|Mean
2636524|NCT01790594|Secondary|HbA1c at Baseline (Pre-Transplant) Through Wk 52 Post-Transplant|"Hemoglobin A1c (HbA1c) measures the average blood glucose levels over 8-12 weeks, thus acting as a useful long-term gauge of blood glucose control:~A value below 6.0% reflects normal levels,~6.0% to 6.4% reflects prediabetes, and~a value of ≥ 6.5% reflects diabetes."|Baseline (Pre-Transplant) and Days 28, 84, and Weeks 28, 36, and 52|Intent-to-treat population with available data|||percent||Standard Deviation|Mean
2636525|NCT01790594|Secondary|Count of Participants With Evidence of Pancreatic Loss at Week 52 Post-Transplant|C-peptide is a measure of pancreatic function. The definition of pancreatic loss: a C-peptide value of <0.3 ng/mL.|Week 52 Post-Transplant|Intent-to-treat population with available data|||Participants|||Count of Participants
2636526|NCT01790594|Secondary|Count of Participants With Evidence of Partial Pancreatic Graft Function at Week 52 Post-Transplant|C-peptide is a measure of pancreatic function. The definition of partial pancreatic graft function: a fasting C-peptide levels >0.3ng.mL (0.1nmol.L) plus the participant's continued requirement for exogenous insulin or oral hypoglycemic agent(s).|Week 52 Post-Transplant|Intent-to-treat population with available data|||Participants|||Count of Participants
2636527|NCT01790594|Secondary|Count of Participants With Full Pancreatic Graft Function (Insulin Independent) at Wk 52 Post-Transplant|Participants with full pancreatic graft functions are defined as those that no longer require exogenous insulin therapy.|Week 52 Post-Transplant|Intent-to-treat population|||Participants|||Count of Participants
2636528|NCT01790594|Secondary|Count of Participants With Delayed Graft Function at Wk 52 Post-Transplant|Delayed grafted function is defined as dialysis in the first week on one or more occasions for any indication other than the treatment of acute hyperkalemia in the setting of otherwise acceptable renal function.|Transplant through Week 52 Post-Transplant|Intent-to-treat population|||Participants|||Count of Participants
2636529|NCT01790594|Secondary|Count of Participants With Successful Discontinuation of Tacrolimus in Recipients Randomized to the Investigational Arm|Participants achieved successful discontinuation if they were able to discontinue (e.g., off tacrolimus therapy completely) over a 4-8 weeks after tacrolimus withdrawal was initiated at week 40.|Week 40 through week 48 Post-Transplant|Intent-to-treat population with available data|||Participants|||Count of Participants
2636530|NCT01790594|Secondary|The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Post-Transplant|"The estimated Glomerular Filtration Rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):~A score of ≥ 90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate very severe or endstage kidney failure.~An estimate of the slope, or change over time, in eGFR was produced using standard statistical linear modeling procedures. The estimate was then re-scaled so that it could be interpreted as a change in eGFR per month. Positive numbers indicate increasing kidney function.~Larger numbers indicate greater change in kidney function."|Day 28 through Week 52 Post-Transplant|Intent-to-treat population|||eGFR change over time (by month)||Standard Deviation|Mean
2636531|NCT01790594|Secondary|Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant|"The estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease equation (MDRD):~A score of ≥ 90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate severe or endstage kidney failure."|Week 52 Post-Transplant|Intent-to-treat population|||mL/min/1.73m^2||Standard Deviation|Mean
2636532|NCT01790594|Secondary|Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant|"The stages of Chronic Kidney Disease (CKD) are defined using the participant's GFR value:~Stage 1 if GFR value is ≥ 90 (kidney function is normal)~Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease)~Stage 3A if 45 <= GFR < 60*~Stage 3B if 30 <= GFR < 45*~Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function)~Stage 5 if GFR < 15 (severe or end stage kidney failure).~Stages 3A abd 3B indicate moderately reduced kidney function.*"|Week 52 Post-Transplant|Intent-to-treat population|||Participants|||Count of Participants
2636533|NCT01790594|Secondary|Count of Participants by CKD Stage at Wk 52 Post-Transplant|"The stages of Chronic Kidney Disease are defined using the participant's GFR value:~Stage 1 if GFR value is ≥90 ( kidney function is normal)~Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease)~Stage 3A if 45 ≤ GFR < 60*~Stage 3B if 30 ≤ GFR < 45*~Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function)~Stage 5 if GFR < 15 (severe or end stage kidney failure).~Stages 3A and 3B indicate moderately reduced kidney function.*"|Week 52 Post-Transplant|Intent-to-treat population|||Participants|||Count of Participants
2636582|NCT01790295|Secondary|Association of Cytokines Levels With Acute and Chronic GvHD||30 days post transplant|This data was not collected because the study ended early.||||||
2636583|NCT01790295|Secondary|Expression Profiling and Measurements of Cytokines Prior to Start of Ruxolitinib, Prior to Start of Chemotherapy for Conditioning||100 days post transplant|This data was not collected because the study ended early.||||||
2636535|NCT01790594|Primary|Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant|"eGFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI):~A score of ≥90 means kidney function is normal.~A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease.~Scores between 30 and 59 indicates moderately reduced kidney function.~Scores between 15 and 29 indicate severely reduced kidney function.~Scores below 15 indicate very severe or end stage kidney failure."|Week 52 Post-Transplant|Intent-to-treat population with available data at week 52.|||mL/min/1.73m^2||Standard Deviation|Mean
2636536|NCT01790581|Secondary|Self-assessed Disability|3 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Ankle Instability Instrument, the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.|Change from baseline disability at 1-month post intervention|||||||
2636537|NCT01790581|Secondary|Self-assessed Disability|2 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport.|Change from baseline disability at 1-week post intervention|||||||
2636538|NCT01790581|Primary|Self-assessed Disability|2 questionnaires regarding self-assessed disability during activities of daily living and sport will be completed. The questionnaires will include the Foot and Ankle Ability Measure, and the Foot and Ankle Ability Measure-Sport. The FAAM contains 21 activity related items (max score of 84) while the FAAM-S contains 8 activity related items (max score of 32). Lower percentages (patient's score divided by max score) represent greater disability, and both FAAM and FAAM-S scores have been found to be reliable and precise (r=0.89, SEM= 2.1 and r=0.87, SEM= 4.5, respectively) in people with CAI.|Disability to 1-day post intervention||||% of total questionnaire points||Standard Deviation|Mean
2636539|NCT01790581|Secondary|Balance|Dynamic balance will be assessed with the Star Excursion Balance Test (SEBT). This test requires a person to maintain their balance on a single limb while reaching as far as they can (with their other leg) in 3 different directions (forward, back-left, and back-right).|Change from baseline balance at 1-week post intervention|||||||
2636540|NCT01790581|Primary|Balance|Dynamic balance will be assessed with the Star Excursion Balance Test (SEBT). This test requires a person to maintain their balance on a single limb while reaching as far as they can (with their other leg) in 3 different directions (forward, back-left, and back-right).|Balance at 1-day post intervention||||% of leg length||Standard Deviation|Mean
2636541|NCT01790568|Secondary|Non-Relapse Mortality Incidence||1 year||||percentage of patients||95% Confidence Interval|Number
2636542|NCT01790568|Secondary|Percentage of Patients Alive at 1 Year|Overall survival at 1 Year.|1 Year||||percentage of patients||95% Confidence Interval|Number
2636543|NCT01790568|Primary|Percentage of Patients That Experience Grade 2-4 GVHD Within 100 Days of Transplant|"GVHD Staging:~Grade 2: (Skin) Maculopapular rash 25-50% BSA, (Liver) bilirubin 3.1-6mg/dl, (Gut) 1000-1500 ml/day for adult and 20-30ml/kg/day for child.~Grade 3: (Skin) Maculopapular rash >50% BSA, (Liver) 6.1-15mg/dl, (Gut) >1500mg/day for adult and >30ml/kg/day for child.~Grade 4: (Skin) Generalized erythroderma plus bullous formation and desquamation >5% BSA, (Liver) >15mg/dl, (Gut) Severe abdominal pain with or without ileus, or grossly bloody stool."|100 Days||||percentage of patients||95% Confidence Interval|Number
2636544|NCT01790516|Primary|Feasibility of Returning Genetic Testing Results in a Timely Manner to the Treating Physician|"Feasibility is defined as follows:~- Patients' genetic test results are returned to the treating physician within 3 days"|20 months||||days||Full Range|Median
2636545|NCT01790503|Secondary|Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 2, the Combined RP2D Groups in Phase 1b, and in the Study Overall Modified Intent-To-Treat Population||Approximately 2 years|Abnormal chemistry and hematology values were assessed in the mITT population.|||Participants|||Count of Participants
2636546|NCT01790503|Secondary|Number of Patients With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events by Preferred Term in Phase 1b of the Modified Intent-To-Treat Population||Approximately 2 years|Abnormal chemistry and hematology values were assessed in the mITT population.|||Participants|||Count of Participants
2636547|NCT01790503|Secondary|Overview of Most Frequent System Organ Classes Reported in Phase 2 of the Modified Intent-To-Treat Population||Approximately 2 years|Safety was assessed in the mITT population.|||Participants|||Count of Participants
2636548|NCT01790503|Secondary|Overview of Most Frequent System Organ Classes Reported in Phase 1b of the Modified Intent-To-Treat Population||Approximately 2 years|Safety was assessed in the mITT population.|||Participants|||Count of Participants
2636549|NCT01790503|Secondary|Summary of Best Overall Response by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose|Best Overall Response (based on the RANO response) was defined as the highest overall response recorded from the start of study treatment until the end of treatment. Per the Response Assessment in Neuro-Oncology (RANO) criteria for measurable lesions and assessed by Cranial MRI scan, summarized as: Complete Response (CR), Disappearance of all enhancing disease (measurable and non-measurable); Partial Response (PR), >=50% decrease of all measurable enhancing lesions; Stable disease, does not qualify for complete response, partial response, or progression, and progression, >25% increase in enhancing lesions despite stable or increasing steroid use or any new lesions.|Approximately 2 years|Best Overall Response was assessed in the mITT RP2D population.|||Participants|||Count of Participants
2636550|NCT01790503|Secondary|Summary of the Overall Survival by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose|"Overall Survival was calculated using a non-parametric Kaplan-Meier analysis method. Median OS was analyzed by age group, extent of surgery, baseline Karnofsky Performance Status (KPS), and O6-methylguanine-DNA methyltransferase status (MGMT).~The scale range for the baseline Karnofsky Performance Status is from 0-100, with 0 indicating that the participant is dead and 100 indicating that the participant is Normal no complaints, no evidence of disease. The higher the number, the better the outcome."|Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.|OS was assessed in the mITT RP2D population.|||months||90% Confidence Interval|Median
2673269|NCT01462877|Secondary|Change in Serum Creatinine|Blood tests|Baseline up to 8 weeks after intervention|Safety set|||percentage of Creatinine change||Full Range|Median
2636551|NCT01790503|Secondary|Summary of the Overall Survival in the Study Group Compared With Historical Control From Medical Literature|Overall Survival was calculated using a parametric model. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control used for statistical analysis. Additionally, RTOG-0825 was also used to support this outcome measure|Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.|Median OS was based on model parameters estimated by maximum likelihood with a Newton-Raphson algorithm. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control.|||months||95% Confidence Interval|Median
2636552|NCT01790503|Secondary|Summary of the Overall Survival in The Study Population|Overall Survival (OS) was defined as the number of days from the first day of treatment (C1D1) to the date of death and analyzed using a non-parametric Kaplan Meier method.|Approximately 2 years|OS was assessed in the mITT RP2D and PP RP2D populations.|||months||90% Confidence Interval|Median
2636553|NCT01790503|Secondary|Summary of the Median Progression-free Survival (mPFS) by Subgroups in the Modified Intent-To-Treat Population on the Recommended Phase 2 Dose|"Progression was determined by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS) was analyzed based on the non-parametric Kaplan-Meier method. mPFS was analyzed by age group, extent of surgery, baseline Karnofsky Performance Status (KPS), and O6-methylguanine-DNA methyltransferase status (MGMT).~The scale range for the baseline Karnofsky Performance Status is from 0-100, with 0 indicating that the participant is dead and 100 indicating that the participant is Normal no complaints, no evidence of disease. The higher the number, the better the outcome."|Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.|mPFS was assessed in the mITT RP2D population.|||months||90% Confidence Interval|Median
2636554|NCT01790503|Primary|Summary of the Median Progression-free Survival (mPFS) in the Study Group Compared With Historical Control From Medical Literature|mPFS was based on model parameters estimated by maximum likelihood with a Newton-Raphson algorithm. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control used for statistical analysis. Additionally, RTOG-0825 was also used to support this outcome measure.|Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.|mPFS was based on model parameters estimated by maximum likelihood with a Newton-Raphson algorithm. The Radiation Therapy Oncology Group (RTOG) 0525 study was the main historical control.|||months||95% Confidence Interval|Median
2636555|NCT01790503|Primary|Summary of the Median Progression-free Survival (mPFS) in the Combined 800 mg, 5 Days/Week Dose Group|Progression was determined by Response Assessment in Neuro-Oncology (RANO) criteria and progression-free survival (PFS) was analyzed based on the non-parametric Kaplan-Meier method.|Assessed from date of first dose administered to date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.|mPFS was assessed in the modified intent-to-treat RP2D and the per protocol (PP) populations.|||months||90% Confidence Interval|Median
2636556|NCT01790490|Primary|Change in Motivation to Quit|Motivation score obtained from the University of Rhode Island Change Assessment (URICA). Scores are obtained at baseline and at 24 hours after each infusion. The scores are 0-13, with higher scores indicating greater motivation. The analysis is within-subject. Scores included below are means; higher scores represent higher motivation to quit than do lower scores.|Baseline and 24 hours post-infusion||||units on a scale||Full Range|Mean
2636557|NCT01790490|Primary|Change in Cue Reactivity|Serial visual analogue scale (VAS) scores for craving elicited by cocaine cue: units on a scale (0-200), high is worse. Scores are obtained at baseline and at 24 hours after the infusion.|Baseline and 24 hours after infusion||||units on a scale (0-200), high is worse||Standard Error|Median
2636558|NCT01790438|Secondary|Change From Baseline to 26 Weeks in European Quality of Life (EQ-5D-3L) - Visual Analog Scales (VAS) Scores|The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score was self-reported using a visual analogue scale (VAS) marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state.|Baseline, 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable EuroQol-5D-3L data.|||units on a scale||Standard Deviation|Mean
2636559|NCT01790438|Secondary|Percentage of Participants With Severe Hypoglycemic Events|Hypoglycemic event are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A severe hypoglycemic event was defined as a hypoglycemic episode requiring assistance of another person to actively administer carbohydrates, glucagon, or other resuscitative actions. The percentage of participants with at least one severe hypoglycemia is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable hypoglycemic data at baseline and with at least one post-baseline value.|||percentage of participants|||Number
2636560|NCT01790438|Secondary|Rate of Severe Hypoglycemic Events|Hypoglycemic event are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A severe hypoglycemic event was defined as a hypoglycemic episode requiring assistance of another person to actively administer carbohydrates, glucagon, or other resuscitative actions. The hypoglycemia rate per 100 years during a defined period was calculated by the number of hypoglycemia events within the period divided by the number of days participant at risk within the period*36525 days.|Baseline through 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable hypoglycemic data at baseline and with at least one post-baseline value.|||events per 100 participant years||Standard Deviation|Mean
2636561|NCT01790438|Secondary|Percentage of Participants With Injection Site Reactions|The percentage of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH.|||percentage of participants|||Number
2636562|NCT01790438|Secondary|Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia|Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking. Percentage of participants was calculated by the number of participants reaching target HbA1c without nocturnal hypoglycemia divided by the total number of participants analyzed, multiplied by 100.|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable HbA1c data and hypoglycemia data.|||percentage of participants|||Number
2636563|NCT01790438|Secondary|Percentage of Participants With Total and Nocturnal Hypoglycemic Events|Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking. Percentage of participants was calculated by the number of participants with at least one hypoglycemia divided by the total number of participants analyzed, multiplied by 100.|Baseline through 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable hypoglycemic data at baseline and with at least one post-baseline value.|||percentage of participants|||Number
2636564|NCT01790438|Secondary|Intra-Participant Variability in FBG by the Coefficient of Variation|Glucose variability was assessed by between-day variability as measured by the standard deviation or the coefficient of variation of the FBG of the last 7 days prior to the visit using SMBG.|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable FBG data.|||mg/dL||Geometric Coefficient of Variation|Geometric Mean
2636565|NCT01790438|Secondary|Intra-Participant Variability in FBG by Standard Deviation|Glucose variability was assessed by between-day variability as measured by the standard deviation or the coefficient of variation of the FBG of the last 7 days prior to the visit using SMBG. LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No], baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline FBG variability as the fixed effects.|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable FBG data.|||mg/dL||Standard Deviation|Least Squares Mean
2636566|NCT01790438|Secondary|Percentage of Participants With Insulin Antibodies|The percentage of participants with a positive treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR was defined as change from baseline to postbaseline in the anti-LY2605541 antibody level either (1) from undetectable to detectable or (2) from detectable to the value with at least 130% relative increase from baseline. Percentage of participants was calculated by dividing the number of participants with TEAR anytime during the treatment period by the total number of participants analyzed, multiplied by 100.|Baseline to 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable anti-drug (LY2605541) antibodies (ADA) data.|||percentage of participants|||Number
2636567|NCT01790438|Secondary|Change From Baseline to 26 Weeks in Lipid Profile|Lipid profile includes total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides. LS means for post-baseline measures were calculated using MMRM with the fixed effects of stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, sulfonylureas/meglitinide use, and LDL-C [<100 mg/dL and ≥100 mg/dL], except for the LDL-C outcome variable), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable. LS means for End Of Study measures were calculated using ANCOVA adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, sulfonylureas/meglitinide use, and LDL-C [<100 mg/dL and ≥100 mg/dL]except for the LDL-C outcome variable), treatment, and baseline value of corresponding lipid outcome variable.|Baseline, 26 Weeks; Baseline, End Of Study (EOS) (Up to 30 Weeks)|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable lipid data. Missing endpoints for End Of Study measures were imputed with the LOCF method.|||mg/dL||Standard Error|Least Squares Mean
2636568|NCT01790438|Secondary|Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores|Adult LBSS (also referenced as Hypoglycemia Fear Survey - II [HFS-II]) contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (always). Items are categorized in 2 domains: Behavior (or avoidance) with 15 items and Worry (or affect) with 18 items. Sum all the items to obtain a total score (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, stratification factor (country, baseline sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c (≤8.5% or >8.5%), and baseline value of LBSS.|Baseline, 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable LBSS data. Missing endpoints were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2636569|NCT01790438|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ) Score|ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, Insulin Delivery Device. Data presented are the transformed score on a scale of 0-100, higher scores indicate better treatment satisfaction. LS means were calculated using analysis of variance (ANOVA) adjusting for treatment and stratification factors (country, baseline sulfonylureas/meglitinide use [Yes/No], baseline HbA1c [≤8.5% or >8.5%]).|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable ITSQ data. Missing endpoints were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2636584|NCT01790295|Secondary|Expression Profiling and Measurements of Cytokines Prior to Start of Ruxolitinib, Prior to Start of Chemotherapy for Conditioning||30 days post transplant|This data was not collected because the study ended early.||||||
2636585|NCT01790295|Secondary|Mean Change in the Brief Fatigue Inventory Score|Mean change in the Brief Fatigue Inventory score (BFI) from baseline to 48 months to assess impact of allogeneic stem cell transplant on myelofibrosis associated symptoms and overall quality of life. The BFI is a 9 item scored from 0 (no fatigue) -10 (as bad as you can imagine), items are averaged with total score from 0-10, with higher score indicating more fatigue.|baseline and 48 months||||score on a scale||95% Confidence Interval|Mean
2636586|NCT01790295|Secondary|Number of Overall Survival||1-year post transplant||||Participants|||Count of Participants
2636570|NCT01790438|Secondary|Change From Baseline to 26 Weeks in European Quality of Life - 5 Dimension 3 Levels (EQ-5D-3L) Index|The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and extreme problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United States (US) population-based algorithm. The EQ-5D-3L US based index scores ranged from -0.11 to 1.0 where a score of 1.0 indicates perfect health. LS means were calculated from ANCOVA using treatment, stratification factor (country, baseline sulfonylurea sulfonylureas/meglitinide use [Yes/No], baseline HbA1c strata [≤8.5% or >8.5%]) and baseline value of EQ-5D-3Las covariates.|Baseline, 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable EQ-5D-3L data. Missing endpoints were imputed with the last observation carried forward (LOCF) method.|||units on a scale||Standard Error|Least Squares Mean
2636571|NCT01790438|Secondary|Time to Steady-State (Stable Maximum Dose)|Steady-state was defined as the first local maximum dose (peak dose value) of LY2605541 or human insulin NPH within the window of -2 to +2 weeks. The median time to steady-state of basal insulin dose estimated from Kaplan-Meier analysis was summarized by treatment.|Baseline through 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable steady state data.|||weeks||95% Confidence Interval|Median
2636572|NCT01790438|Secondary|Insulin Dose Per Kilogram (kg) of Body Weight|LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, and treatment-by-visit interaction as the fixed effects.|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable insulin dose and body weight data.|||units per kilogram||Standard Error|Least Squares Mean
2636573|NCT01790438|Secondary|HbA1c|HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable HbA1c data.|||percentage of HbA1c||Standard Error|Least Squares Mean
2636574|NCT01790438|Secondary|Change From Baseline to 26 Weeks in Body Weight|LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline weight as the fixed effects.|Baseline, 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable body weight data.|||kilograms (kg)||Standard Error|Least Squares Mean
2636575|NCT01790438|Secondary|6-Point Self-Monitored Blood Glucose (SMBG)|6-point SMBG profiles were obtained on 3 nonconsecutive days in the week prior to Weeks 0, 4, 8, 12, 16, and 26. The SMBG measurements were performed while fasting (prior to the morning meal [breakfast]), prior to the midday meal (lunch), prior to the evening meal (dinner), at bedtime, at approximately 0300 hours, and the next day fasting (prior to the morning meal). LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), ], baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline SMBG at the same time point of the response variable as the fixed effects.|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable blood glucose data.|||mg/dL||Standard Error|Least Squares Mean
2636576|NCT01790438|Secondary|Fasting Blood Glucose (FBG) (by Self Monitoring)|LS means were calculated from MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline value of the response variable as the fixed effects.|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable FBG data.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2636577|NCT01790438|Secondary|Fasting Serum Glucose (FSG) (by Laboratory)|LS means were calculated from MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), baseline HbA1c strata [≤8.5% or >8.5%]), visit, treatment-by-visit interaction, and baseline value of the response variable as the fixed effects.|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable FSG.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2636578|NCT01790438|Secondary|Percentage of Participants With HbA1c ≤6.5% and <7.0%|Percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.|26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable HbA1c data.|||Percentage of Participants|||Number
2636579|NCT01790438|Secondary|30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events|Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of <=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking. Group mean rates of total and nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models with treatment, baseline sulfonylurea/meglitinide use, baseline event rate of the corresponding hypoglycemia as covariates, log (exposure/30 days) as the offset in the model. Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.|Baseline through 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable hypoglycemic data at baseline and with at least one post-baseline value.|||episodes per participant per 30 days||Standard Error|Mean
2636580|NCT01790438|Primary|Change From Baseline to 26 Weeks in Hemoglobin A1c (HbA1c)|Glycosylated hemoglobin A1 (HbA1c) is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated by mixed model repeated measures (MMRM) using treatment, stratification factors (country, sulfonylureas/meglitinide use [Yes/No]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.|Baseline, 26 Weeks|Participants who received at least one dose of LY2605541 or human insulin NPH with evaluable HbA1c data.|||percentage of HbA1c||Standard Error|Least Squares Mean
2636581|NCT01790295|Secondary|Association of Cytokines Levels With Acute and Chronic GvHD||100 days post transplant|This data was not collected because the study ended early.||||||
2636588|NCT01790295|Secondary|Number of Participants With Relapse/Progression (Defined as Per IWG-MRT Criteria)|"Relapse/progression defined as:~Peripheral blood: Hemoglobin ≥100 g/L and <UNL; neutrophil count ≥1 × 109/L and <UNL; platelet count ≥100 × 109/L and <UNL; <2% immature myeloid cells‡ and Clinical: Resolution of disease symptoms; spleen and liver not palpable; no evidence of EMH or Bone marrow:* Age-adjusted normocellularity; <5% blasts; ≤grade 1 MF†, and peripheral blood: Hemoglobin ≥85 but <100 g/L and <UNL; neutrophil count ≥1 × 109/L and <UNL; platelet count ≥50, but <100 × 109/L and <UNL; <2% immature myeloid cells‡ and Clinical: Resolution of disease symptoms; spleen and liver not palpable; no evidence of EMH"|1-year post transplant||||Participants|||Count of Participants
2636589|NCT01790295|Secondary|Number of Participants With Remission Status at 12 Months Post Transplant|"Remission defined as:~Bone marrow:* Age-adjusted normocellularity; <5% blasts; ≤grade 1 MF† and Peripheral blood: Hemoglobin ≥100 g/L and <UNL; neutrophil count ≥ 1 × 109/L and <UNL; Platelet count ≥100 × 109/L and <UNL; <2% immature myeloid cells‡ and Clinical: Resolution of disease symptoms; spleen and liver not palpable; no evidence of EMH"|12 months post transplant||||Participants|||Count of Participants
2636590|NCT01790295|Secondary|Number of Participants With Remission Status at 6 Months Post Transplant|"Remission defined as:~Bone marrow:* Age-adjusted normocellularity; <5% blasts; ≤grade 1 MF† and Peripheral blood: Hemoglobin ≥100 g/L and <UNL; neutrophil count ≥ 1 × 109/L and <UNL; Platelet count ≥100 × 109/L and <UNL; <2% immature myeloid cells‡ and Clinical: Resolution of disease symptoms; spleen and liver not palpable; no evidence of EMH"|6 months post transplant||||Participants|||Count of Participants
2636591|NCT01790295|Secondary|Number of Participants With Remission Status According to IWG-MRT Criteria|"Remission status according to International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria~Remission defined as:~Bone marrow:* Age-adjusted normocellularity; <5% blasts; ≤grade 1 MF and Peripheral blood: Hemoglobin ≥100 g/L and <UNL; neutrophil count ≥ 1 × 109/L and <UNL; Platelet count ≥100 × 109/L and <UNL; <2% immature myeloid cells and Clinical: Resolution of disease symptoms; spleen and liver not palpable; no evidence of extramedullary hematopoiesis (EMH)"|Day 100 post transplant||||Participants|||Count of Participants
2636592|NCT01790295|Secondary|Chimerism Studies|Will check percentage of donor versus recipient blood cells to determine efficacy of donor engraftment|100 days post transplant|This data was not collected because the study ended early.||||||
2636593|NCT01790295|Secondary|Chimerism Studies|Will check percentage of donor versus recipient blood cells to determine efficacy of donor engraftment|60 days post transplant|This data was not collected because the study ended early.||||||
2636594|NCT01790295|Secondary|Chimerism Studies|Will check percentage of donor versus recipient blood cells to determine efficacy of donor engraftment|30 days post transplant|This data was not collected because the study ended early.||||||
2636595|NCT01790295|Secondary|Percent of Participants With Graft Versus Host Disease (GvHD)|"Acute and chronic GvHD. GvHD is a potentially serious complication of allogeneic stem cell transplantation.~Stage Skin Liver (bilirubin) Gut (stool output/day)~0 No GVHD rash < 2 mg/dl < 500 ml/day or persistent nausea.~Maculopapular rash< 25% body surface area (BSA) 2-3 mg/dl 500-999 ml/day~Maculopapular rash 25 - 50% BSA 3.1-6 mg/dl 1000-1500 ml/day~Maculopapular rash > 50% BSA 6.1-15 mg/dl Adult: >1500 ml/day~Generalized erythroderma plus bullous formation >15 mg/dl Severe abdominal pain with or without ileus Grade I Stage 1-2 None None II Stage 3 or Stage 1 or Stage 1 III - Stage 2-3 or Stage 2-4 IV Stage 4 or Stage 4 -"|1-year post transplant||||percentage of participants||95% Confidence Interval|Number
2636596|NCT01790295|Secondary|Percent of Participants With Non-relapse Mortality (NRM)|NRM will be defined as death in first 30 days due to any cause, and subsequently death due to any cause without the recurrence or progression of myelofibrosis. Cumulative incidence of NRM will be calculated taking relapse/progression as competing event.|1-year post transplant||||percentage of participants||95% Confidence Interval|Number
2636597|NCT01790295|Secondary|Percent of Participants With Non-relapse Mortality (NRM)|NRM will be defined as death in first 30 days due to any cause, and subsequently death due to any cause without the recurrence or progression of myelofibrosis. Cumulative incidence of NRM will be calculated taking relapse/progression as competing event.|100 days||||percentage of participants||95% Confidence Interval|Number
2636598|NCT01790295|Secondary|Platelet Recovery|Platelet recovery will be defined as first of the 7 days with platelet count ≥20 x 109/l, without platelet transfusion support and both maintained for 30 days without transfusion support or myeloid cytokine support.|up to 4 years||||days||95% Confidence Interval|Median
2636599|NCT01790295|Secondary|Time to Neutrophil Recovery|Neutrophil recovery will be defined as first of the three consecutive days with neutrophil count ≥0.5 x 109/l.|up to 4 years||||days||95% Confidence Interval|Median
2636600|NCT01790295|Primary|Percent of Participants With 100-day Survival Without Graft Failure|The feasibility of combining Ruxolitinib (INC424) with a Reduced intensity conditioning (RIC) regimen likely to produce success post transplantation, success being defined as patient being alive, and without graft failure at day 100-post allogeneic stem cell transplantation (in patients who receive (a) related donor transplant and in those who receive (b) an unrelated donor transplant.|Day 100-post allogeneic stem cell transplantation||||percentage of participants||95% Confidence Interval|Number
2636601|NCT01790178|Secondary|Number of Participants With Inadequate Biopsy Samples|The presence of an inadequate sample was determined by the blinded pathologist reading the muscle biopsies. This reflects the sample having enough preserved muscle tissue for histologic analysis. It is separate from the number of participants receiving a diagnosis. A sample may be adequate, but non-diagnostic. Only one biopsy was performed in each patients, so the number of biopsies is the same as the number of participants.|At time of pathology review||||Inadequate Biopsy Samples|||Number
2636602|NCT01790178|Secondary|Number of Times Biopsy Needle Was Inserted to Obtain Biopsy Tissue|"For core or needle biopsies, the physician passes the needle into the muscle until they feel that adequate tissue samples have been obtained. This outcome measure is the number of passes required in each study arm."|At time of biopsy||||needle passes||Standard Deviation|Mean
2636603|NCT01790178|Secondary|Number of Participants With Adverse Events Related to Muscle Biopsy|Data will be examined to determine if ultrasound guidance reduces the rate of adverse events in muscle biopsies.|Patient involvement limited to the time of biopsy; Records analyzed up to 10 months after biopsy||||participants|||Number
2636606|NCT01790126|Secondary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)|An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Treatment-emergent adverse events are those that occurred between the date of 1st dose of study drug and date of last dose of study drug plus 30 days.|From date of 1st dose of study drug to date of last dose of study drug plus 30 days (up to 6 years)|The safety population included all participants who received at least 1 dose of study drug as actually treated.|||Percentage of participants|||Number
2636607|NCT01790126|Secondary|Change From Baseline in Estradiol Levels|Change from baseline in estradiol levels was reported.|Baseline, Day 35 (Cycle 6 and Cycle 12)|The ITT population included all randomized participants and was classified according to their assigned treatment group, regardless of the actual treatment received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Picomoles per liter (pmol/L)||Standard Error|Least Squares Mean
2636608|NCT01790126|Secondary|Change From Baseline in Serum Dihydrotestosterone (DHT) Levels|Change from baseline in serum DHT levels was reported.|Baseline, Day 35 (Cycle 6 and Cycle 12)|The ITT population included all randomized participants and was classified according to their assigned treatment group, regardless of the actual treatment received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Nanomoles per liter (nmol/L)||Standard Error|Least Squares Mean
2636609|NCT01790126|Secondary|Median Time to Serum Testosterone Recovery to Greater Than (>) 50 ng/dL (Non-castrate) and > 150 ng/dL|The time to serum testosterone recovery to > 50 ng/dL and > 150 ng/dL from Month 13 to Month 24 of protocol therapy was reported.|Month 13 to Month 24|mITT included subset of ITT population for outcomes related to testosterone recovery, participants who withdrew from the study prior to 24 months after Day 1 were excluded from the analysis. This outcome measure was planned to be analyzed and reported for LHRHa-based treatment arms.|||Months||95% Confidence Interval|Median
2636610|NCT01790126|Secondary|Change From Baseline in Bone Mineral Density (BMD)|Change from baseline in BMD was assessed for femoral neck and lumber spine with DEXA scans.|Baseline, Cycle 12 Day 35|The ITT population included all randomized participants and was classified according to their assigned treatment group, regardless of the actual treatment received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Gram per centimeter square (g/cm^2)||Standard Error|Least Squares Mean
2636611|NCT01790126|Secondary|Change From Baseline in Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol and Triglycerides|Change from baseline in cholesterol, HDL cholesterol, LDL cholesterol and triglycerides were analyzed and reported using a mixed-model for repeated measures.|Baseline, Day 35 (Cycle 3, 6, 9 and 12)|The ITT population included all randomized participants and was classified according to their assigned treatment group, regardless of the actual treatment received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||mmol/L||Standard Error|Least Squares Mean
2636612|NCT01790126|Secondary|Change From Baseline in Glycated Hemoglobin (HbA1C)|The change from baseline in HbA1C was analyzed and reported using a mixed-model for repeated measures.|Baseline, Day 35 (Cycle 3, 6, 9 and 12)|The ITT population included all randomized participants and was classified according to their assigned treatment group, regardless of the actual treatment received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Percentage of HbA1C||Standard Error|Least Squares Mean
2636613|NCT01790126|Secondary|Change From Baseline in Fasting Plasma Glucose|The change from baseline in fasting plasma glucose levels was analyzed and reported using a mixed-model for repeated measures.|Baseline, Day 35 (Cycle 3, 6, 9 and 12)|The ITT population included all randomized participants and was classified according to their assigned treatment group, regardless of the actual treatment received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2636614|NCT01790126|Secondary|Change From Baseline in Body Mass Index (BMI)|Change from baseline in BMI was reported. BMI was calculated as 'body weight in kg/(height in meters)* (height in meters)'. Endpoint values are from the last measurement within the analysis period.|Baseline, Day 1 (Cycle 1), Day 28 (Cycle 1, 2, 4, 5, 7, 8, 10 and 11), Day 35 (Cycle 3, 6, 9 and 12) and endpoint (up to 24 months)|"The safety population included all participants who received at least 1 dose of study drug as actually treated. Here, 'n' (number of participants analyzed) signifies the number of participants analyzed at a specified time point. Number Analyzed=0 signifies that no participants were evaluated for the specified parameter at that time point."|||Kilogram per meter square (kg/m^2)||Standard Deviation|Mean
2636615|NCT01790126|Secondary|Percentage of Participants With a Serum PSA Less Than 0.2 ng/mL|Percentage of participants with PSA less than (<) 0.2 ng/mL after 7 months of protocol therapy were reported.|From 7 to 24 months|mITT included subset of ITT population for outcomes related to testosterone recovery, participants who withdrew from the study prior to 24 months after Day 1 were excluded from the analysis. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Percentage of participants|||Number
2636616|NCT01790126|Secondary|Percentage of Participants Without PSA or Radiographic Progression and With Recovery of Serum Testosterone|Percentage of participants without evidence of PSA or radiographic progression during the 24-month treatment period and with recovery of serum testosterone at 24 months were reported. Testosterone recovery was defined as a serum testosterone greater than (>) 150 nanogram per deciliter (ng/dL). PSA progression was defined as a rise to greater than 50 percent (%) of the baseline serum PSA or rise of 2 nanogram per milliliter (ng/mL) or more above the nadir, whichever is higher, confirmed by repeat measurement at least 2 weeks later. Radiographic progression was defined as the detection of new metastasis on either bone scan or cross-sectional imaging (computed tomography [CT] or magnetic resonance imaging [MRI]).|Up to 24 months|Modified Intent-to-treat Population (mITT) included subset of ITT population for outcomes related to testosterone recovery, participants who withdrew from the study prior to 24 months after Day 1 were excluded from the analysis. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.|||Percentage of participants|||Number
2636617|NCT01790126|Secondary|Time to Prostate Specific Antigen (PSA) Progression Based on Modified Prostate Cancer Clinical Trials Working Group (PCWG2) Criteria|PSA progression was defined as a rise to greater than 50 percent (%) of the baseline serum PSA or rise of 2 nanogram per milliliter (ng/mL) or more above the nadir, whichever is higher, confirmed by repeat measurement at least 2 weeks later.|Up to 24 months|The ITT population included all randomized participants and was classified according to their assigned treatment group, regardless of the actual treatment received.|||Months||95% Confidence Interval|Median
2636618|NCT01790126|Secondary|Change From Baseline in Sexual Health Inventory for Men (SHIM) Total Score at 3, 12, 24 Months|The SHIM is a well validated abridged 5-item of the 15-item International Index of Erectile Function, which has been extensively studied in men with erectile dysfunction due to various etiologies, including prostate cancer-related therapies. It consists of 5 items pertaining to sexual functioning, with scores ranging from 0-5 for most items. The total score is obtained by adding all five item scores, and can range from 5 to 25. Higher scores indicate higher level of sexual function and less erectile dysfunction.|Baseline, at 3, 12, 24 months|The ITT population included all randomized participants and was classified according to their assigned treatment group, regardless of the actual treatment received.|||Units on a scale||Standard Error|Least Squares Mean
2636619|NCT01790126|Secondary|Change From Baseline in EORTC Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Score at 3, 12 and 24 Months|EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It Consist of 25 questions distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions on a 4 point scale (1 'Not at all' to 4 'Very much'). All raw domain scores are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of activity or functioning (sexual).|Baseline, at 3, 12 and 24 months|The ITT population included all randomized participants and was classified according to their assigned treatment group, regardless of the actual treatment received.|||Units on a scale||Standard Error|Least Squares Mean
2636620|NCT01790126|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score at 3, 12 and 24 Months|"EORTC QLQ-C30 is a 30 items self-reporting questionnaire resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Questionnaire includes 28 items with 4-point Likert type responses from 1-not at all to 4-very much to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall health related quality of life. Scores are transformed to 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms."|Baseline, at 3, 12 and 24 months|The ITT population included all randomized participants and was classified according to their assigned treatment group, regardless of the actual treatment received.|||Units on a scale||Standard Error|Least Squares Mean
2636621|NCT01790126|Secondary|Change From Baseline in FACT-P Total Score at 3 and 24 Months|FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACT-General (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life.|Baseline, at 3 and 24 months|The ITT population included all randomized participants and was classified according to their assigned treatment group, regardless of the actual treatment received.|||Units on a scale||Standard Error|Least Squares Mean
2636622|NCT01790126|Primary|Change From Baseline in Functional Assessment of Cancer Therapy - Prostate (FACT-P) Total Score at 12 Months|FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS). The FACT-General (FACT-G) is a 27 item Quality of Life (QoL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional Well-being (0-24). The total score range is between 1-108, higher scores indicates better for total score and subscale scores. PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). The FACT-P total score is the sum of all 5 subscale scores of the FACT-P questionnaire and ranges from 0-156. Higher scores indicate higher degree of functioning and better quality of life.|Baseline, at 12 months|The intent-to-treat (ITT) population included all randomized participants and was classified according to their assigned treatment group, regardless of the actual treatment received.|||Units on a scale||Standard Error|Least Squares Mean
2636623|NCT01790048|Secondary|Adverse Events|Any adverse events from the supplementary foods reported in the 3 month time frame.|3 months||||Participants|||Count of Participants
2636624|NCT01790048|Secondary|Time to Graduation|The amount of time required for a patient to reach recovery|3 months||||days||Standard Deviation|Mean
2636625|NCT01790048|Secondary|Mid-Upper-Arm Circumference (MUAC) Gain|Gain in mid-upper arm circumference|3 months||||mm/d||Standard Deviation|Mean
2636626|NCT01790048|Secondary|Height|Amount of height gained over the intervention period.|3 months||||mm/d||Standard Deviation|Mean
2636627|NCT01790048|Secondary|Weight|Amount of weight gained over the course of treatment|3 months||||Gain (g/kg/day)||Standard Deviation|Mean
2636628|NCT01790048|Primary|Recovery From Moderate Acute Malnutrition (MAM)|The primary outcome measures will be recovery from MAM (achieving MUAC ≥ 12.5 cm by 12 weeks) or failure (death, development of severe acute malnutrition, transfer to hospital for inpatient care, failure to recover from MAM by 12 weeks, default).|3 months||||Participants|||Count of Participants
2636686|NCT01789203|Secondary|Number of Patients With Gram Negative Urinary Tract Infections at 6 Months|Number of patients with gram negative urinary tract infections as defined by a midstream urine sample containing 10^4 or more colony-forming units per mL|6 months||||Participants|||Count of Participants
2636629|NCT01789970|Secondary|Participants With Potentially Clinically Significant Abnormal Electrocardiogram Findings During the Double-Blind Treatment Period|Data represents the number of participants with potentially clinically significant (PCS) electrocardiogram findings on the final study visit.|Final study visit (week 12 or end of treatment visit)|Full analysis set|||Participants|||Count of Participants
2636630|NCT01789970|Secondary|Participants With Potentially Clinically Significant Abnormal Vital Sign Values During the Double-Blind Treatment Period|"Data represents participants with potentially clinically significant (PCS) vital sign values.~Significance criteria~Pulse - high: >=120 and increase of >= 15 beats/minute from baseline~Pulse - low: <=50 and decrease of >=15 beats/minute~Systolic blood pressure - high: >=180 and increase >=20 mmHg~Systolic blood pressure - low: <=90 and decrease >=20 mmHg~Diastolic blood pressure - high: >=105 and increase of >=15 mmHg~Diastolic blood pressure - low: <=50 and decrease of >=15 mmHg"|Day 1 to Week 12 of the Treatment Period|Full analysis set|||Participants|||Count of Participants
2636631|NCT01789970|Secondary|Participants With Potentially Clinically Significant Abnormal Laboratory Values During the Double-Blind Treatment Period|"Data represents participants with potentially clinically significant abnormal serum chemistry, hematology and urinalysis values.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Creatinine: >=177 μmol/L~Uric acid: M>=625, F>=506 μmol/L~Alanine aminotransferase (ALT): >=3* upper limit of normal (ULN)~Gamma-glutamyl transpeptidase (GGT): >=3* upper limit of normal (ULN)~Serum white blood cells: <=3.0 * 10^9/L~Hemoglobin: M<=115, F<=95 g/dL~Hematocrit: M<0.37, F<0.32 L/L~Eosinophils: >=10.0 %~Absolute neutrophils: <=1.0 * 10^9/L~Urinalysis: Glucose: >=2 unit increase from baseline"|Day 1 up to Week 12 of the Treatment Period|Full analysis set including participants with laboratory assessments. Participants with a postbaseline result for that test are counted in each laboratory tests' label.|||Participants|||Count of Participants
2636632|NCT01789970|Secondary|Clinical Opiate Withdrawal Scales (COWS) Total Scores During the Double-Blind Treatment Period|"COWS is a clinician-rated scale used to measure a participant's signs and symptoms of withdrawal from opiates, with ratings based only on apparent relationship to withdrawal. The COWS was performed at weeks 1, 2, 4, and 12 (double blind treatment period) or early termination. The scale contained 11 signs/symptoms whose intensity the clinician rated on a scale of 0 to 4 or 5.~A total score was calculated as the sum of the responses to the 11 signs/symptoms for a total range of 0-48. Withdrawal severity was classified, based on the total score, as follows:~0 to 4=normal~5 to 12=mild~13 to 24=moderate~25 to 36=moderately severe~36=severe"|Weeks 1, 2, 4 and Endpoint of the Treatment Period|Full analysis set. Participants contributing to each time point are listed in the time point label.|||units on a scale||Standard Deviation|Mean
2636633|NCT01789970|Secondary|Subjective Opiate Withdrawal Scales (SOWS) Total Scores During the Double-Blind Treatment Period|The results of the SOWS were collected in the e-diary daily during the first 4 weeks of the double blind treatment period and then during clinic visits at week 12 or early termination. The SOWS was a self-administered questionnaire used to measure a participant's signs and symptoms of withdrawal from opiates. The scale contained 16 symptoms (such as my nose is running; I feel restless), the participant rated the intensity on a scale of 0 (not at all) to 4 (extremely) for a total score of 0-64. The daily total score for the first 4 weeks was the largest score observed during the time period preceding that visit. For example, the week 1 score for each participant was the largest total score on any day between baseline and the night before the week 1 visit; the week 4 score for each participant was the largest score observed between the week 2 visit and the night before the week 4 visit.|Weeks 1, 2, 4 and Endpoint of the Treatment Period|Full analysis set. Participants contributing to each time point are listed in the time point label.|||units on a scale||Standard Deviation|Mean
2636634|NCT01789970|Secondary|Participants With Clinically Significant Hearing Changes From Baseline to Final Assessment in Pure Tone Audiometry Test Results|"Pure tone audiometry was performed by a qualified audiologist and was not done at the study center. During the test, the patient wore headphones and was seated in a quiet room; trained personnel manipulated the audiometry equipment to test the patient's hearing. For serial audiograms, the criteria for a clinically significant (CS) hearing change were based on the guidance from the American Speech-Language Hearing Association (ASHA) 1994 (Konrad-Martin et al 2005). These criteria included the following: greater than 20 decibels (dB) pure tone threshold shift at 1 frequency; greater than 10 dB shift at 2 consecutive test frequencies; or threshold response shifting to no response at 3 consecutive test frequencies."|Days 7-14 of Titration Period (baseline), Day 0 of Treatment Period (last day of Titration Period), Week 12 or end of study visit during the Treatment Period|Safety analysis set (entire study), Full analysis set (treatment period)|||Participants|||Count of Participants
2636635|NCT01789970|Secondary|Participants With Adverse Events During Open-Label Titration and Double-Blind Treatment Periods|An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 of Titration Period up to Week 12 of Treatment Period (maximum treatment duration was 127 days)|Safety analysis set (Titration Period) and Full analysis set (Treatment Period)|||Participants|||Count of Participants
2636636|NCT01789970|Secondary|Change From Baseline to Final On-Treatment Visit in Roland Morris Disability Questionnaire (RMDQ) Score|The RMDQ is a patient-rated, 24-question evaluation used to assess acute disability associated with low back pain. Each question is answered with a YES or NO response, and each YES response is given 1 point. Scores on the RMDQ range from 0 to 24, with higher scores indicating greater disability. Negative change from baseline scores indicate improvement in level of disability.|Days 7-14 of Titration Period (baseline), Week 12 or end of study visit during the Treatment Period|Full analysis set, including participants with RMDQ score for the final on-treatment visit.|||units on a scale||Standard Deviation|Mean
2636747|NCT01788163|Secondary|Time Since First Non-small-cell Lung Carcinoma (NSCLC) Diagnosis by Tumor EGFR Mutation|Number of months since the first diagnosis of NSCLC from informed consent date.|At Screening|Tumour Evaluable Population|||Months||Standard Deviation|Mean
2636637|NCT01789970|Secondary|Percentage of Participants With a 30% or Greater Increase in Weekly Average Pain Intensity (API) From Baseline to Week 12 Visit, and an Average API Score of 5 or Higher at Week 12|The API over the last 24 hours was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. Participants selected the number that best described the average pain intensity over the last 24 hours. Weekly API scores averaged daily scores collected over the previous 7 days for each analysis visit.|Days -6 to 0 of Treatment Period (baseline), Week 12|Full analysis set, including participants with observed weekly average API for week 12|||percentage of participants|||Number
2636638|NCT01789970|Secondary|Kaplan-Meier Estimates for Time to Loss of Efficacy|Time to loss of efficacy was defined as discontinuation of study drug for lack of efficacy or the start of excessive rescue medication while taking study drug. Excessive rescue medication usage was defined as 10 or more days of rescue medication usage in any 14 consecutive days at a total of 15 mg (hydrocodone-equivalent) or higher each day during the post 2-week tapering period of the double-blind treatment period.|Day 1 to Week 12 of Treatment Period|The full analysis set, which includes all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline efficacy observation.|||days||95% Confidence Interval|Median
2636639|NCT01789970|Secondary|Change From Baseline to Week 12 of the Treatment Period in Weekly Average Pain Intensity (API)|"The API over the last 24 hours was recorded daily by patients in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. Participants selected the number that best described the average pain intensity over the last 24 hours. Weekly API scores averaged daily scores collected over the previous 7 days for each analysis visit. Negative change from baseline scores indicate improvement in pain control.~The analysis included API data observed before discontinuation of study drug and was based on the MI method to handle missing scores at week 12. Consistent with the recommendations of the National Academy of Sciences (NAS) report (Panel on Handling Missing Data in Clinical Trials 2010), the MI method includes an assumption of missing at random (MAR) and takes into account a potential bias toward the active-drug treatment group for patients who discontinued study drug because of adverse events."|Days -6 to 0 of Treatment Period (baseline), Week 12|The full analysis set, which includes all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline efficacy observation.|||units on a scale||Standard Error|Mean
2636640|NCT01789970|Primary|Change From Baseline to Week 12 of the Treatment Period in Weekly Average of Daily Worst Pain Intensity (WPI)|"The WPI was recorded daily by participants in an electronic diary using an 11-point numerical rating scale (NRS-11), a Likert-type scale in which 0=no pain and 10=the worst pain imaginable. Participants selected the number that best described their worst pain intensity over the last 24 hours. Weekly WPI scores averaged daily scores collected over the previous 7 days for each analysis visit. Negative change from baseline scores indicate improvement in pain control.~The analysis included WPI data observed before discontinuation of study drug and was based on the multiple imputations (MI) method to handle missing scores at week 12. Consistent with the recommendations of the National Academy of Sciences (NAS) report (Panel on Handling Missing Data in Clinical Trials 2010), the MI method includes an assumption of missing at random (MAR) and takes into account a potential bias toward the active-drug treatment group for patients who discontinued study drug because of adverse events."|Days -6 to 0 of Treatment Period (baseline), Week 12 of Treatment Period|The full analysis set, which includes all randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline efficacy observation.|||units on a scale||Standard Error|Mean
2636641|NCT01789905|Secondary|Clinical Response Rate of Cure|"The cure rate, which was defined as the percentage of participants who were assessed as cure over the total number of assessable effectiveness analysis population (cure plus failure), was presented along with two-sided 95% CI. Clinical response of cure was assessed as cure, failure, or indeterminate by the physician within 28 days post-treatment."|Within 28 days post-treatment|The analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at the Test-of-Cure visit at least once. Participants evaluated as “indeterminate (n=38) ” were excluded from the calculation.|||Percentage of Participants||95% Confidence Interval|Number
2636642|NCT01789905|Secondary|Clinical Response Rate|"Clinical response rate, which was defined as the percentage of participants who achieved clinical response as effective over the total number of assessable effectiveness analysis population(effective plus ineffective,) was presented along with two-sided 95% CI. Clinical response of Tygacil was assessed as effective, ineffective, or indeterminate by the physician at the end of observation period. Overall response of Tygacil was determined by the physician based on laboratory and clinical findings without bacteriological findings."|Within 14 days from the start date|The analysis set comprised of participants in the safety analysis set who had effectiveness evaluation at the end date of the observation period at least once. Participants evaluated as “indeterminate (n=28)” were excluded from the calculation.|||Percentage of Participants||95% Confidence Interval|Number
2636643|NCT01789905|Primary|Number of Participants With Adverse Drug Reaction (ADR)|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Tygacil in a participant who received Tygacil. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Tygacil was assessed by the physician.|Up until 14 days from the start date and 28 days from the end of the observation period|The safety analysis set comprised of participants who had received Tygacil at least once.|||Participants|||Number
2636656|NCT01789606|Primary|Percentage of Participants With the Use of Study Medication For Less Than or Equal to (<=) 10 Days and Use More Than 20 Tablets With an Average Daily Dose of Greater Than (>) 1600 mg|Percentage of participants who used the study medication for <=10 days and used more than 20 tablets with an average daily dose of >1600 mg were reported in this outcome measure.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.|||percentage of participants||95% Confidence Interval|Number
2641621|NCT01744392|Secondary|Cholesterol & Creatinine Levels at 6 Months|Clinical Characteristics at 6 months for LDL, HDL,Total Cholesterol and Creatinine|6 months||||mg/dL||Standard Deviation|Mean
2636644|NCT01789814|Primary|Change From Baseline in ADP-mediated Platelet Aggregation, APP, SFFLRN, AYPGKF.|"To document the extent of inhibition of ADP mediated platelet aggregation following the discontinuation of bivalirudin therapy in patients treated with prasugrel as compared to patients treated with clopidogrel.~The percent inhibition of platelet aggregation was measured by light transmission aggregometry of platelet-rich plasma in response to P2Y12 and PAR1 and PAR4 thrombin receptor agonists at baseline and at 1, 2, 4 and 16 h following the cessation of bivalirudin infusion. Platelet response to agonists: 20 mM ADP(P2Y12), 5 mM SFLLRN (PAR1), and 160 mM AYPGKF (PAR4) was performed. The magnitude of inhibition of platelet aggregation for each agonist was calculated as the mean final change from baseline in light transmission aggregometry at each time point."|Baseline, 60, 120, 240, 960 mins following termination of bivalirudin infusion|24 patients referred for intervention with planned bivalirudin therapy, not previously treated with a P2Y12 inhibitor and not receiving heparins or GP IIb/IIIa inhibitors were randomized to treatment with either clopidogrel (600 mg) or prasugrel (60 mg).|||% inhibitn of platelet aggregation|||Number
2636645|NCT01789775|Primary|Composite Success Assessment (CEA) and Patient Self Assessment(PSA).|Composite Success is defined as 1-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).|Day 29||||participants|||Number
2636646|NCT01789775|Secondary|Composite Success Assessment (CEA) and Patient Self Assessment(PSA).|30 Minutes Effect is defined as 1 grade improvement on CEA and PSA at 30 minutes.|D1|||||||
2636647|NCT01789606|Secondary|Maximum Daily Dose of Study Medication||Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.|||milligram||Standard Deviation|Mean
2636648|NCT01789606|Secondary|Average Daily Dose of Study Medication||Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.|||milligram||Standard Deviation|Mean
2636649|NCT01789606|Secondary|Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram Excluding Treatment of Severe Symptoms|In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg, excluding the events when severe symptoms were treated, were reported.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.|||dosing occasions||Standard Deviation|Mean
2636650|NCT01789606|Secondary|Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram|In this outcome measure, number of dosing occasions exceeding the single dose of 600 mg were reported.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.|||dosing occasions||Standard Deviation|Mean
2636651|NCT01789606|Secondary|Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram Excluding Treatment of Severe Symptoms|In this outcome measure, number of treatment days exceeding the daily dose of 1200 mg, excluding the days when severe symptoms were treated, were reported.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.|||days||Standard Deviation|Mean
2636652|NCT01789606|Secondary|Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram|Number of treatment days when participants exceeded the daily dose of 1200 milligram were reported in this outcome measure.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.|||days||Standard Deviation|Mean
2636653|NCT01789606|Secondary|Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users|In this outcome measure, number of pain episodes treated with single dose or multiple dose per day among inappropriate users were reported. Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of <6 hours, based on the information provided at the follow up interview.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available. ‘N’ is participants evaluable for this outcome measure.|||pain episodes||Standard Deviation|Mean
2636654|NCT01789606|Secondary|Number of Dosing Days Among Inappropriate Users|Participants were considered as inappropriate users if they improperly used the study medication in their last pain episode duration of <6 hours, if left untreated, based on the information provided at the follow up interview.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available. ‘N’ is participants evaluable for this outcome measure.|||days||Standard Deviation|Mean
2636655|NCT01789606|Secondary|Average Daily Dose Among Excessive Users|Excessive users included all participants who used the study medication for more than 10 days (not necessarily consecutive) during study period with an average daily dose of >1600 mg or all participants who used the study medication for <=10 days during study period, used more than 20 tablets and had an average daily dose of >1600 mg.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available. ‘N’ is participants evaluable for this outcome measure.|||milligram||Standard Deviation|Mean
2641622|NCT01744392|Secondary|Cholesterol & Creatinine Levels at Baseline|Clinical Characteristics at Baseline for LDL, HDL,Total Cholesterol and Creatinine|baseline||||mg/dL||Standard Deviation|Mean
2636657|NCT01789606|Primary|Percentage of Participants With the Use of Study Medication For Greater Than (>) 10 Days With an Average Daily Dose of Greater Than (>) 1600 mg|Percentage of participants with the use of study medication for >10 days with an average daily dose of >1600 mg were reported in this outcome measure.|Day 1 up to Day 30|This outcome measure was not planned to be analysed in self-selection arm. Analysis population included all participants of compliance arm who received at least 1 dose of the study drug during the 30 days and returned the completed study diary, or any information on dosing which was available.|||percentage of participants||95% Confidence Interval|Number
2636658|NCT01789606|Primary|Percentage of Participants Who Select to Use Ibuprofen 200 mg IR Medication With a Typical Pain Duration of Greater Than or Equal to (>=) 6 Hours|Percentage of participants with selection of Ibuprofen 200 mg IR medication with a typical duration of pain >=6 hours were reported in this outcome measure. These participants were classified as ''missed opportunity'' cases.|Day 1|This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire. Here, 'N' signifies participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2636659|NCT01789606|Primary|Percentage of Participants Who Select to Use Ibuprofen 600 mg IR/ER Medication With a Typical Pain Duration of Less Than (<) 6 Hours|Percentage of participants with correct selection of Ibuprofen 600 mg IR/ER medication with a typical duration of pain <6 hours were reported in this outcome measure.|Day 1|This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire. Here, 'N' signifies participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2636660|NCT01789606|Primary|Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 mg IR/ER Study Medication Excluding Those Classified as Missed Opportunity|"Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of >=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of <6 hours, if left untreated. Participants were classified as missed opportunity cases when they selected the Ibuprofen 200 mg IR medication with their typical duration of pain >=6 hours."|Day 1|This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire. Here, 'Number of Participants Analyzed (N)' signifies participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2636661|NCT01789606|Primary|Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 Milligram (mg) Immediate Release (IR) or Extended Release (ER) Study Medication|Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of >=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of less than (<) 6 hours, if left untreated.|Day 1|This outcome measure was not planned to be analysed in compliance arm. Analysis population included all participants enrolled in the self-selection arm of the study and completed the self-selection questionnaire.|||percentage of participants||95% Confidence Interval|Number
2636662|NCT01789567|Other Pre-specified|Composite Clinical Efficacy Endpoint After 30 Days According to VARC2|"Percentage of Participants with any of the following Safety Events after 30-days post-procedure:~All-cause mortality All stroke Hospitalization for valve-related symptoms or worsening congestive heart failure"|30-days post-procedure|Analysis for this endpoint includes subjects at risk (or alive and in study) at 30 days.|||percentage of participants|||Number
2636663|NCT01789567|Other Pre-specified|Composite 30-day Safety Endpoint According to VARC2|"Percentage of Participants with any of the following Safety Events within 30-days post-procedure:~All-cause mortality All stroke Life-threatening bleeding Acute kidney injury (stage 2-3) Coronary artery obstruction requiring intervention Major vascular complication Valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVR)"|30-days post-procedure|Analysis for this endpoint includes subjects with an implant attempt.|||percentage of participants|||Number
2636664|NCT01789567|Other Pre-specified|Device Success According to VARC2|"Device success is a composite of:~Absence of 30-day in-hospital death Correct position of the device within the aortic annular region Intended performance of the bioprosthesis (no patient-prosthesis mismatch, mean aortic gradient <20 mmHg or peak velocity <3 m/s at discharge, and no moderate or severe prosthetic valve regurgitation)"|30 days post-procedure|Analysis for this endpoint includes subjects with an implant attempt.|||percentage of participants||95% Confidence Interval|Number
2636665|NCT01789567|Primary|Acute Delivery System Success|Acute delivery system success, defined as bioprosthesis deployed in anatomically correct position and freedom from delivery system related complications at the end of the procedure.|Within 30 days of implant procedure|Analysis for this endpoint includes subjects with an implant attempt.|||percentage of participants||95% Confidence Interval|Number
2636666|NCT01789476|Secondary|Summed Pain Intensity Differences Over 48 Hours (SPID 0-48) Following the Initial Administration of Study Drug|"Patients reported their pain intensity using a visual analogue scale (VAS) from 0 to 100 mm, where 0 mm represented No Pain and 100 mm represented the Worst Pain You Can Imagine. SPID 0-24 represents the cumulative time-weighted sum of the pain intensity difference (PID) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 0 to 15 min, 15 to 30 min, etc.) over 24 hours. Pain intensity assessments were measured at baseline (entry pain score) and at 15, 30, 45, 60, 90, 120 and 150 minutes; 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 hours after the first administration of study drug.~Negative SPID values represent a decrease in pain intensity (i.e. lower values indicate a greater reduction in pain)."|Up to 48 hours|The analysis included all patients in the Completer population who completed the trial, where time 0 was the start time of the first dose of study drug.|||units on a scale * hours||Standard Deviation|Mean
2636684|NCT01789203|Secondary|Number of Patients With Quinolone-resistant Infection at 6 Months|Number of patients with quinolone-resistant gram negative bacterial infections, among those with a gram-negative infection|6 months||||Participants|||Count of Participants
2636667|NCT01789476|Secondary|Summed Pain Intensity Differences Over 36 Hours (SPID 0-36) Following the Initial Administration of Study Drug|"Patients reported their pain intensity using a visual analogue scale (VAS) from 0 to 100 mm, where 0 mm represented No Pain and 100 mm represented the Worst Pain You Can Imagine. SPID 0-24 represents the cumulative time-weighted sum of the pain intensity difference (PID) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 0 to 15 min, 15 to 30 min, etc.) over 24 hours. Pain intensity assessments were measured at baseline (entry pain score) and at 15, 30, 45, 60, 90, 120 and 150 minutes; 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 hours after the first administration of study drug (only timepoints up to 36 hours used in calculating SPID 0-36).~Negative SPID values represent a decrease in pain intensity (i.e. lower values indicate a greater reduction in pain)."|Up to 36 hours|The analysis included all patients in the Completer population who completed the trial, where time 0 was the start time of the first dose of study drug.|||units on a scale * hours||Standard Deviation|Mean
2636668|NCT01789476|Primary|Summed Pain Intensity Differences Over 24 Hours (SPID 0-24) Following the Initial Administration of Study Drug|"Patients reported their pain intensity using a visual analogue scale (VAS) from 0 to 100 mm, where 0 mm represented No Pain and 100 mm represented the Worst Pain You Can Imagine. SPID 0-24 represents the cumulative time-weighted sum of the pain intensity difference (PID) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 0 to 15 min, 15 to 30 min, etc.) over 24 hours. Pain intensity assessments were measured at baseline (entry pain score) and at 15, 30, 45, 60, 90, 120 and 150 minutes; 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 hours after the first administration of study drug (only timepoints up to 24 hours used in calculating SPID 0-24).~Negative SPID values represent a decrease in pain intensity (i.e. lower values indicate a greater reduction in pain)."|0 to 24 hours|The analysis included all patients in the Completer population who completed the trial, where time 0 was the start time of the first dose of study drug.|||units on a scale * hours||Standard Deviation|Mean
2636669|NCT01789255|Secondary|Median Plasma Concentration of IL-6 in Patients Treated With Vorinostat and Patients Not Treated With Vorinostat|Median plasma concentration of IL-6 (Interleukin-6 cytokine) was compared in patients treated with Vorinostat to those not treated with Vorinostat.|Up to day 100|This trial consisted of an initial pilot phase, funded by the NCI, that enrolled 12 patients (NCT01789255). The trial was extended to enroll an additional 25 patients. The results presented here include information for all 37 patients. The analysis population description for all 37 patients can be found under NCT01790568.|||pg/mL||Full Range|Median
2636670|NCT01789255|Secondary|Median Ac-H3 Levels in Patients Treated With Vorinostat and Patients Not Treated With Vorinostat|Median Ac-H3 levels ( depicted as a ratio of ac-H2 optical density (OD) and beta actin OD) were compared in patients treated with Vorinostat to patients not treated with Vorinostat. Optical Density is a dimensionless unit.|Up to day 100|This trial consisted of an initial pilot phase, funded by the NCI, that enrolled 12 patients (NCT01789255). The trial was extended to enroll an additional 25 patients. The results presented here include information for all 37 patients. The analysis population description for all 37 patients can be found under NCT01790568.|||Ratio||Full Range|Median
2636671|NCT01789255|Secondary|The Percentage of Patients With Relapse at 1 Year||Up to 1 year||||percentage of patients|||Number
2636672|NCT01789255|Secondary|The Percentage of Patients Alive at 1 Year|The percentage of patients alive at 1 year|Up to 1 year|This trial consisted of an initial pilot phase, funded by the NCI, that enrolled 12 patients (NCT01789255). The trial was extended to enroll an additional 25 patients. The results presented here include information for all 37 patients. The analysis population description for all 37 patients can be found under NCT01790568.|||percentage of patients|||Number
2636673|NCT01789255|Secondary|The Percentage of Patients Alive Without GVHD or Use of Steroids|The percentage of patients alive without GVHD or use of steroids at 1 year.|Up to 1 year|This trial consisted of an initial pilot phase, funded by the NCI, that enrolled 12 patients (NCT01789255). The trial was extended to enroll an additional 25 patients. The results presented here include information for all 37 patients. The analysis population description for all 37 patients can be found under NCT01790568.|||percentage of patients|||Number
2636674|NCT01789255|Secondary|Mean Percent of Planned Dose Administered|The addition of vorinostat to tacrolimus and methotrexate for GVHD prophylaxis will be considered feasible if 60% or more of the planned doses are administered.|Up to day 30||||percent of dose administered||Full Range|Mean
2636675|NCT01789255|Primary|The Number of Participants That Experience Grade 2-4 Acute GVHD (Graft Versus Host Disease) by Day 100|"The incidence of grade 2-4 acute GVHD (Graft Versus Host Disease) by day 100~Grade 2 GVHD: Maculopapular rash covering 25-50% of BSA (Body Surface Area), bilirubin between 3.1-6 mg/dl, and/ or adult stool output between 1000-1500 ml/day (child between 20-30 ml/kg/day).~Grade 3 GVHD: Maculopapular rash covering >50% of BSA, bilirubin between 6.1-15 mg/dl, and/ or adult stool output >1500 ml/day (child >30 ml/kg/day).~Grade 4 GVHD: Generalized erythroderma plus bullous formation and desquamation >5% BSA, bilirubin >15 mg/dl, and/ or severe abdominal pain with or without ileus, or grossly bloody stool."|Day 100||||participants|||Number
2636676|NCT01789203|Other Pre-specified|Death at 1 Year|Patient death at 1 year|12 months||||Participants|||Count of Participants
2636677|NCT01789203|Other Pre-specified|Graft Loss at 1 Year|kidney failure within first 1 year of transplant|12 months||||Participants|||Count of Participants
2636678|NCT01789203|Secondary|Acute Rejection at 1 Year|Number of patients with biopsy-proven acute rejection of the allograft at 1 year, based on Banff classification|12 months||||Participants|||Count of Participants
2636679|NCT01789203|Secondary|First Plasma Viral Loads|First BK plasma viral loads|12 months|included 31 ciprofloxacin and 8 placebo patients who became BK viremic during the first year|||copies/mL||Inter-Quartile Range|Median
2636680|NCT01789203|Secondary|BK Viremia at 1 Year|Proportion of patients developing BK viremia at 1 year|12 months||||Participants|||Count of Participants
2636681|NCT01789203|Secondary|Time to BK Infection|Median time to initial BK viremia episode, days|12 months|Included 31 ciprofloxacin and 8 placebo patients who became BK viremic during the first 12 months|||days||Inter-Quartile Range|Median
2636682|NCT01789203|Secondary|Serious Adverse Events|Serious adverse events collected for up to 4 months (3 months on study drug plus 1 additional month)|4 months||||Participants|||Count of Participants
2636683|NCT01789203|Secondary|Clostridium Difficile at 6 Months|Clostridium difficile infection at 6 months|6 months||||Participants|||Count of Participants
2636687|NCT01789203|Primary|Number of Patients Developing BK Infection at 6 Months Post-transplant|Number of patients (followed by proportion) developing BK infection at 6 months post-transplant. BK infection is defined as the presence of a detectable BK viral load in plasma by polymerase chain reaction (PCR), or the presence of BK viral inclusions on kidney biopsy specimens.|6 months||||Participants|||Count of Participants
2636688|NCT01789138|Secondary|HIV-1 RNA Count / Viral Load (VL)|Undetectable viral load: HIV-1 RNA <40 copies/mL|12 months|Number of participants who completed the 12-month study|||participants|||Number
2636689|NCT01789138|Primary|Antiretroviral Therapy (ART) Adherence (Self-reported 3-day Recall Measure)||12 months|Number of participants who completed the study|||participants|||Number
2636690|NCT01789047|Other Pre-specified|Hoehn & Yahr Staging|Hoehn & Yahr staging of Parkinson's disease is completed by the blinded treating physician assessing the subject|Assessment completed at baseline, week 6, week 10 and week 14|||||||
2636691|NCT01789047|Other Pre-specified|Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)|This is a 4-part scale that rates both non-motor and motor (including dyskinesia) aspects of Parkinson's disease. Parts of the scales will be completed by the blinded treating physician while assessing the subject and other parts will be self-completed by the subject|Assessed at baseline, week 6, week 10 and week 14|||||||
2636692|NCT01789047|Other Pre-specified|Clinical Global Impression - Change Score|"The Clinical Global Impression - Change score is an ordinal measure of change with a range of 0 (not assessed) to 7 (very much worse). A score of 4 is associated with no change."|Assessed at Week 10 and 14 by blinded treating physician and subject|||||||
2636693|NCT01789047|Primary|The Unified Dyskinesia Rating Scale (UDysRS)|The Unified Dyskinesia Rating Scale (UDysRS) will be the primary outcome measure for this study. This choice is based on the outcome of the Validation of Dyskinesia Rating Scales study. In this study, the UDysRS was identified as the most sensitive scale to detect change in dyskinesia in an 8-week, double-blind, placebo-controlled trial of amatadine. The UDysRS utilizes rater information, patient self-report and objective measures of dyskinesia to provide assessments of impairment and disability due to dyskinesia. Score ranges are 0-108 with higher scores representing more severe impairment.|Change from baseline to week 14 (end of study) on the Unified Dyskinesia Rating Scale|Last Observation Carried Forward imputation|||units on a scale||Standard Deviation|Mean
2636694|NCT01788943|Secondary|Change in Cigarette Craving as Measured by the Questionnaire on Smoking Urges.|Measure is post-scan subtracted from pre-scan ratings. Rating is measured using the standardized, Questionnaire on Smoking Urges - Brief Version (QSU-Brief) is a standardized measure consisting of 10 statements, each rated on a Likert-like scale from 1 (Strongly Disagree) to 7 (Strongly Agree). Responses for each item are summed to produce an overall score with a range of 10-70.|Before and immediately following the PET scan.||||units on a scale||Standard Deviation|Mean
2636695|NCT01788943|Primary|Acetylcholinergic Nicotine Receptor Availability as Determined by 2FA -PET Brain Imaging.|Acetylcholinergic Nicotine Receptor availability in the thalamus is decreased in smokers with slower rates of nicotine metabolism.|following overnight nicotine abstinence||||Distribution Volume Ratio (Vt/fp)||Standard Deviation|Mean
2636696|NCT01788631|Secondary|Level of Inflammatory Markers (IFN-gamma)|To determine if regadenoson reduces levels of inflammatory markers among individuals with SCA and pain or ACS compared to placebo.|Baseline-End of study infusion over 48 hours|All patients who had baseline and end of treatment samples|||IFN-gamma levels as percent of baseline||Full Range|Median
2636697|NCT01788631|Secondary|Level of Inflammatory Markers (IL-4)|To determine if regadenoson reduces levels of inflammatory markers among individuals with SCA and pain or ACS compared to placebo.|Baseline-End of study infusion over 48 hours|All patients who had baseline and end of infusion blood samples.|||IL-4 levels as percent of baseline||Full Range|Median
2636698|NCT01788631|Secondary|Level of Inflammatory Markers (A2A)|To determine if regadenoson reduces levels of inflammatory markers among individuals with SCA and pain or ACS compared to placebo.|Baseline-End of study infusion over 48 hours|All patients who had baseline and end of infusion blood samples.|||A2A levels as percent of baseline||Full Range|Median
2636699|NCT01788631|Secondary|Opioid Use|To determine if regadenoson reduces opioid use among individuals with SCA and pain or ACS compared to placebo.|Baseline-End of study infusion over 48 hours|All patients who had baseline and end of infusion blood samples.|||mg/kg/hr||Full Range|Median
2636700|NCT01788631|Secondary|Number of Participants With an Improvement in Respiratory Symptoms|To determine if regadenoson improved respiratory symptoms among individuals with sickle cell anemia (SCA) and pain or acute chest syndrome (ACS) compared to placebo. Patients were classified as having an improvement in respiratory symptoms if they experienced any of the following outcomes:(1) respiratory rate decreased by 25% from baseline or normalized (≤20 bpm) or (2) degree of hypoxia (SpO2) on room air increased by 10% from baseline or normalized (≥92%) or (3) thoracic pain improved by 3 points from baseline on a 10-point visual analog scale.|Baseline-End of study infusion over 48 hours|All patients who had baseline and end of infusion blood samples.|||Participants|||Count of Participants
2636701|NCT01788631|Secondary|Length of Hospital Stay|To determine if regadenoson reduces length of hospital stay among individuals admitted with SCA and pain or ACS compared to placebo|Hospital Presentation- Hospital Discharge, assessed up to 1 month|All patients who had baseline and end of infusion blood samples.|||Days||Full Range|Median
2636702|NCT01788631|Primary|Number of Participants With a Reduction in Invariant Natural-Killer T-Cell (iNKT Cell) Activation by 70% or More|To determine if infusional Regadenoson reduced iNKT cell activation among individuals with sickle cell anemia (SCA) and pain or acute chest syndrome (ACS) compared to placebo by 70% or greater.|Baseline-End of study infusion over 48 hours|Treated patients with baseline and end of infusion blood samples.|||Participants|||Count of Participants
2636703|NCT01788566|Secondary|Number of Participants With Anti-Necitumumab Antibodies|A participant was considered to have an anti-necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point. Treatment emergent antibodies were defined as any anti-necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.|Baseline up to 30 Days Post Last Infusion (up to 17 Months)|All participants who received any amount of study treatment and had evaluable baseline and postbaseline data for antibodies.|||participants|||Number
2637470|NCT01781975|Secondary|Change in Insulin Dose (Units/kg) Over Time|Assess insulin use in units per kilogram body weight per day at weeks 52 and 104.|Visit 9 (Week 52) and Visit 13 (Week 104)||||Units per Kg||95% Confidence Interval|Mean
2636704|NCT01788566|Secondary|Pharmacokinetics (PK): Minimum (Cmin) Maximum Concentration (Cmax) of Necitumumab|Pre-infusion Minimum Concentration (Cmin) and post-infusion (Cmax) necitumumab serum concentration|Predose Cycle 1 Day 8; Cycle 2 through 6 Day 1; End of Infusion (EOI) Cycle 1, 3, 5 Day 1|All participants who received any amount of study treatment and had evaluable data for Cmax|||micrograms/milliliter (ug/ml)||Geometric Coefficient of Variation|Geometric Mean
2636705|NCT01788566|Secondary|Percent Change in Tumor Size (CTS)|CTS is defined as maximum percent improvement from baseline in the sum of target lesions.|Baseline until Measured Progressive Disease (up to 17 Months)|All participants who received any quantity of study treatment and had evaluable baseline and postbaseline data for CTS.|||percent change||Standard Deviation|Mean
2636706|NCT01788566|Secondary|Number of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Disease Control Rate (DCR)]|DCR is best overall response of SD, PR or CR. According to RECIST v1.1, PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. Percentage of participants who achieved disease control = (those participants counted in the denominator with a best tumor response of SD, PR, or CR)/(the same denominator as for ORR)*100.|Baseline to Measured Progressive Disease or Participants Stops Study (up to 17 Months)|All participants who received any quantity of study treatment and had evaluable baseline and postbaseline data for radiographic assessment.|||percentage of participants||95% Confidence Interval|Number
2636707|NCT01788566|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from the date of first dose of study drug until objective progressive disease (PD) or death for any cause. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions was also considered progression. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last complete radiographic assessment.|Baseline to Measured Progressive Disease or Death from Any Cause (up to 17 Months)|All participants who received any quantity of study treatment.|||months||95% Confidence Interval|Median
2636708|NCT01788566|Secondary|Overall Survival (OS)|Overall survival (OS) duration is defined from the date of first dose of study drug to the date of death from any cause. OS was estimated by the Kaplan-Meier method. For participants who were not known to have died as of the data cut-off date, OS was censored at the date of last contact prior to the data cutoff date.|Baseline to Death from Any Cause (up to 17 Months)|All participants who received any amount of study treatment. Participants censored=34.|||months||95% Confidence Interval|Median
2636709|NCT01788566|Primary|Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR)|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: total number of participants with a best tumor response of PR or CR among participants counted in the denominator/total number of participants treated with any amount of study drug, who has a complete radiographic assessment at baseline, and who has at least 1 complete radiographic assessment at postbaseline x 100%.|Baseline to Measured Progressive Disease (up to 17 Months)|All participants who received any amount of study treatment and had evaluable baseline and postbaseline data for radiographic assessment.|||Percentage of participants||95% Confidence Interval|Number
2636710|NCT01788475|Secondary|Time to Reimplantation of Ozurdex Implant|Time in months until new implant is needed|3 years|"I have entered, 0 into the results section due to the fact that this study was terminated early by the study Principal Investigator and no formal medical record extrapolation, database formation, or analysis was conducted."||||||
2636711|NCT01788475|Secondary|Visual Acuity Gain at Year 2 and 3|VA gain in ETDRS letters at years 2 and years 3|3 years|"I have entered, 0 into the results section due to the fact that this study was terminated early by the study Principal Investigator and no formal medical record extrapolation, database formation, or analysis was conducted."||||||
2636712|NCT01788475|Secondary|Comparison of Efficacy Between Group 1 and 2|Comparison of efficacy between group 1 and group 2|3 years|"I have entered, 0 into the results section due to the fact that this study was terminated early by the study Principal Investigator and no formal medical record extrapolation, database formation, or analysis was conducted."||||||
2636713|NCT01788475|Secondary|Central Retinal Thickness Reduction|Central Retinal Thickness Reduction as measured by Heidelberg OCT|1 year|"I have entered, 0 into the results section due to the fact that this study was terminated early by the study Principal Investigator and no formal medical record extrapolation, database formation, or analysis was conducted."||||||
2636714|NCT01788475|Primary|Visual Acuity Gain|Measured visual acuity gain in number of letters improved as a result of treatment|13 months|"I have entered, 0 into the results section due to the fact that this study was terminated early by the study Principal Investigator and no formal medical record extrapolation, database formation, or analysis was conducted."||||||
2636715|NCT01788423|Secondary|Connected Speech Test (CST) Benefit|A standardized speech-perception test, based on meaningful sentences and keyword scoring, the Connected Speech Test (CST) was administered unaided and aided. Each CST score represents the percentage of keywords (out of 50) repeated correctly following presentation via loudspeakers. Scores can range from 0 to 100% correct with higher scores indicating better speech perception. For the CST benefit scores reported below, unaided CST scores are subtracted from aided scores such that positive values represent better performance for aided than unaided listening. The possible range of CST benefit scores is -100 to +100 with 0 representing no difference between unaided and aided speech-perception performance.|two times: at hearing-aid fit and at 6-weeks post-fit||||Percentage of keywords correct||Standard Deviation|Mean
2637323|NCT01782859|Secondary|Pain at 3 Months Post-op|At 3 months postoperatively, patients were asked to rate their pain on a scale of 0-10, with 0 being no pain and 10 being worst pain.|3 months postoperatively||||units on a scale||Standard Deviation|Mean
2636716|NCT01788423|Primary|Profile of Hearing Aid Performance Benefit (PHAB)|"Change from unaided to aided performance on the Profile of Hearing Aid Performance with the difference in aided and unaided scores labeled Profile of Hearing Aid Benefit (PHAB), a self-report measure of benefit. The aided and unaided PHAP scores are proportions of time difficulties encountered in various listening situations. Low PHAP scores indicate less frequent difficulties. When subtracting aided from unaided PHAP scores, a positive PHAB score reflects less frequent problems when wearing a hearing aid compared to without. The range of possible PHAB scores are -1.0 to +1.0 with 0.0 indicating no difference between aided and unaided performance.~There are seven subscales of the PHAP/PHAB and the scores reported are based on the arithmetic means of the five subscales that deal with speech communication, PHABglobal. These include the following subscale scores: EC (Ease of Communication), FT (Familiar Talkers), BN (Background Noise), Reverberation (RV) and Reduced Cues (RC)."|two times: at hearing-aid fit and at 6-weeks post-fit||||Proportion of time had difficulties||Standard Deviation|Mean
2636717|NCT01788358|Secondary|Blood Pressure Response Rate at Weeks 28 and 52|Response rate was defined as the percentage of subjects who achieved a systolic blood pressure response (MSSBP of <140 mmHg or a reduction of MSSBP of more than (>) 20 mmHg from baseline value), or a diastolic blood pressure response (MSDBP of <90 mmHg or a reduction of MSDBP of >10 mmHg from baseline value).|Weeks 28 and 52|mITT|||percentage of subjects|||Number
2636718|NCT01788358|Secondary|Blood Pressure Control Rate at Weeks 28 and 52|Control rate was defined as the percentage of subjects that reached a predetermined blood pressure (BP) target of BP less than (<) 140/90 mmHg.|Weeks 28 and 52|mITT|||percentage of subjects|||Number
2636719|NCT01788358|Secondary|Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52||Baseline (Week 0), Weeks 28 and 52|mITT|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2636720|NCT01788358|Secondary|Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52||Baseline (Week 0), Weeks 28 and 52|Modified intention-to-treat analysis set (mITT): All the subjects enrolled into the open-label treatment period and took at least one unit of the study medication.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2636721|NCT01788358|Secondary|Number of Subjects With Clinically Relevant Changes in Laboratory Parameters|Laboratory evaluations of blood and urine samples were performed, including hematology (hematocrit, hemoglobin, red blood cells count, white blood cells count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets), blood chemistry (sodium, potassium, chloride, bicarbonate, uric acid, total protein, albumin, calcium, blood urea nitrogen, creatinine, aspartate transaminase, alanine transaminase, lactate dehydrogenase, gamma glutamyl transferase, alkaline phosphatase, creatine kinase, total bilirubin, direct bilirubin, total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglycerides, fasting glucose), urinalysis (pH, blood, specific gravity, glucose, protein, cells/sediment). A laboratory test abnormality considered clinically relevant, for example, causing withdrawal by subject, requiring treatment or causing apparent clinical manifestations, or judged relevant by the investigator, were reported as AEs.|Baseline (Week 0) up to Week 52/EOS|SAF|||Subjects|||Number
2636722|NCT01788358|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)|An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported.|From the time of study treatment up to Week 52/EOS|SAF|||Subjects|||Number
2636723|NCT01788358|Primary|Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS)|An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication.|From the time of first study drug administration up to Week 52/EOS|SAF|||Subjects|||Number
2636724|NCT01788358|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28|An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported.|From the time of first study drug administration up to Week 28|SAF|||Subjects|||Number
2636725|NCT01788358|Primary|Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28|An adverse event (AE) is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication.|From the time of first study drug administration up to Week 28|Safety Analysis Set (SAF): All the subjects enrolled into the open-label treatment period and took at least one unit of the study medication.|||Subjects|||Number
2636726|NCT01788228|Secondary|Assessment of Psychometric Validity and Internal Consistency of the Daily SF-36v2 Questionnaire||Day 0 to Day 7 for daily SF-36v2 questionnaires||2020-12-31|12/2020||||
2636727|NCT01788228|Secondary|Assessment of the Quality of Life Measures Overall and by Age Category (18-40; 41-64; 18-64; and >64 Years of Age) Via SF-36v2® Health Assessment Questionnaires||Day 0 and Day 7, Day 21 and Day 28 for weekly SF-36v2 questionnaires and Day 0 to Day 7 for daily SF-36v2 questionnaires||2020-12-31|12/2020||||
2637134|NCT01784848|Secondary|Efficacy of Roux-en-Y Gastroplasty to Decrease the Number of Antihypertensive Drugs.|Evaluate the efficacy of Roux-en-Y Gastric Bypass on the reduction of the number of antihypertensive drugs, maintaining a controlled blood pressure (<140x90 mmHg).|12, 24, 36, 48 and 60 months|||||||
2636728|NCT01788228|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 to Day 385)|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Subjects|||Number
2636729|NCT01788228|Secondary|Number of Subjects Reporting Any and Related Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events (AEs) that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any was defined as occurrence of any pIMD regardless of intensity grade or relation to vaccination. Related was defined as pIMD(s) considered by the investigator to have a causal relationship to vaccination.|During the entire study period (Day 0 to Day 385)|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Subjects|||Number
2636730|NCT01788228|Primary|Number of Subjects Reporting Any Unsolicited AEs, Overall and by Age Category (18-64 and >64 Years of Age)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20 post dose 1 and Days 21-41 post dose 2) post-vaccination period|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Subjects|||Number
2636731|NCT01788228|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age).|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain, muscle ache, shivering, sweating and fever [oral temperature above 38.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature ≥ 39.0°C.|During a 7-day follow-up period (Days 0-6) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Subjects|||Number
2636732|NCT01788228|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms Overall and by Age Category (18-64 and >64 Years of Age).|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During a 7-day follow-up period (Days 0-6) after each vaccination|Analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom safety data were available.|||Subjects|||Number
2636733|NCT01788215|Secondary|Total Number of Ovulations|The total number of ovulations per group. Ovulation was defined as elevation of serum progesterone and or urinary pregnanediol glucuronide followed by documented menstrual bleeding within 2 weeks of elevation.|week 24|In the sugar pill arm, one participant withdrew at week 12.|||ovulations|||Number
2636734|NCT01788215|Secondary|Serum Hormone Binding Globulin (SHBG)||week 24|in the sugar pill arm, one participant withdrew at week 12|||nmol /L||Standard Deviation|Mean
2636735|NCT01788215|Secondary|Serum Hormone Binding Globulin (SHBG)||week 12||||nmol/L||Standard Deviation|Mean
2636736|NCT01788215|Secondary|Free Testosterone in Serum||week 24|in the sugar till arm, one participant dropped out at week 12|||pg/mL||Standard Deviation|Mean
2636737|NCT01788215|Secondary|Free Testosterone in Serum||week 12||||pg/mL||Standard Deviation|Mean
2636738|NCT01788215|Primary|Total Serum Testosterone|We will determine total serum testosterone levels in all participating subjects at week 12.|week 12||||ng/dL||Standard Deviation|Mean
2636739|NCT01788215|Secondary|Serum Progesterone Levels in Blood|Serum progesterone levels will be obtained on a weekly basis to assess ovulation. We will then perform statistical analysis on this data to determine the effectiveness of doxycycline in this study population.|24 weeks|This measurement was not completed, because the number of ovulations was measured in its place and better indicates the effect of the treatment. See outcome measure number 8.||||||
2636740|NCT01788215|Primary|Total Serum Testosterone|We will determine total serum testosterone levels in all participating subjects at week 24.|24 weeks|in the sugar pill arm one participant dropped out at week 12|||ng/dL||Standard Deviation|Mean
2636741|NCT01788163|Secondary|First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status||At Screening|Tumour Evaluable Population|||Participants|||Number
2636742|NCT01788163|Secondary|First Line Treatment Choice by Asia Pacific Country||At Screening|Tumour Evaluable Population|||Participants|||Number
2636743|NCT01788163|Secondary|Number of Organs With Metastasis by Plasma EGFR Mutation Status|Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.|At Screening|Plasma Evaluable Population|||Number||Standard Deviation|Mean
2636744|NCT01788163|Secondary|Time Since First NSCLC Diagnosis by Plasma EGFR Mutation|Number of months since the first diagnosis of NSCLC from informed consent date.|At Screening|Plasma Evaluable Population|||Months||Standard Deviation|Mean
2636745|NCT01788163|Secondary|Demographics and Disease Characteristics by Plasma EGFR Mutation Status|Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry.|At Screening|Plasma Evaluable Population|||Participants|||Number
2636746|NCT01788163|Secondary|Number of Organs With Metastasis by Tumour EGFR Mutation Status|Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.|At Screening|Tumour Evaluable Population|||Number||Standard Deviation|Mean
2636748|NCT01788163|Secondary|Demographics and Disease Characteristics by Tumour EGFR Mutation Status|Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry.|At Screening|Tumour Evaluable Population|||Participants|||Number
2636749|NCT01788163|Secondary|Plasma EGFR Mutation Testing Turnaround Time|Plasma samples were only performed in China, Taiwan, South Korea and Russia. Plasma EGFR mutation testing turnaround time is the number of days from the test request to getting the test result.|At Screening|Enrolled Population|||Time (Days)||Standard Deviation|Mean
2636750|NCT01788163|Secondary|Plasma EGFR Mutation Testing Rates|Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation. Plasma samples were only performed in China, Taiwan, South Korea and Russia.|At Screening|Enrolled Population|||Percentage of Participants|||Number
2636751|NCT01788163|Secondary|Plasma EGFR Mutation Testing|Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequencies of plasma EGFR mutation testing practices parameters.|At Screening|Enrolled Population|||Participants|||Number
2636752|NCT01788163|Secondary|Tumour EGFR Mutation Testing Turnaround Time|Tumour EGFR mutation testing turnaround time is the number of days from the test request to getting the test result.|At Screening|Enrolled Population|||Time (Days)||Standard Deviation|Mean
2636753|NCT01788163|Secondary|Tumour EGFR Mutation Testing Rates|Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation.|At Screening|Enrolled Population|||Percentage of Participants|||Number
2636754|NCT01788163|Secondary|Tumour EGFR Mutation Testing|Frequencies of tumour EGFR mutation testing practices parameters.|At Screening|Enrolled Population|||Participants|||Number
2636755|NCT01788163|Secondary|Predictive Values of Comparison of Mutation Status Between Tumour and Plasma Samples|Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants include only those who had Positive and Negative Predictive tests performed.|At Screening|Tumour and Plasma Evaluable Population|||Percentage|||Number
2636756|NCT01788163|Secondary|Sensitivity and Specificity of Comparison of Mutation Status Between Tumour and Plasma Samples|Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants only include those who had sensitivity and specificity tests performed.|At Screening|Tumour and Plasma Evaluable Population|||Percentage|||Number
2636757|NCT01788163|Secondary|Concordance Rate of Comparison of Mutation Status Between Tumour and Plasma Samples|Plasma samples were only performed in China, Taiwan, South Korea and Russia.|At Screening|Tumour and Plasma Evaluable Population|||Percentage|||Number
2636758|NCT01788163|Primary|Plasma EGFR Mutation Status by Histology|Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country|At Screening|Plasma Evaluable Population|||Percentage of participants||95% Confidence Interval|Number
2636759|NCT01788163|Primary|Plasma EGFR Mutation by Subtype|Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.|At Screening|Plasma Evaluable Population|||Participants|||Number
2636760|NCT01788163|Primary|Overall Plasma EGFR Mutation Status|Plasma samples were only performed in China, Taiwan, South Korea and Russia. The Confidence intervals were calculated using Clopper Pearson method for each country.|At Screening|Plasma Evaluable Population|||Percentage of participants||95% Confidence Interval|Number
2636761|NCT01788163|Primary|Tumour EGFR Mutation Status by Histology|Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country.|At Screening|Tumour Evaluable Population|||Percentage of participants||95% Confidence Interval|Number
2636762|NCT01788163|Primary|Tumour EGFR Mutation by Subtype|Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.|At Screening|Tumour Evaluable Population|||Participants|||Number
2636763|NCT01788163|Primary|Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status|The 95% Confidence intervals were calculated using Clopper Pearson method for each country.|At Screening|Tumour Evaluable Population|||Percentage of participants||95% Confidence Interval|Number
2636764|NCT01788046|Secondary|Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set participants with observed data|||percent change||Standard Error|Mean
2636765|NCT01788046|Secondary|Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set participants with observed data|||percent change||Standard Error|Mean
2636766|NCT01788046|Secondary|Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set participants with observed data|||percent change||Standard Error|Mean
2636767|NCT01788046|Secondary|Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase||Baseline and the Efficacy Assessment Phase (Week 20 to Week 27)|Full analysis set participants with observed data|||percent change||Standard Error|Mean
2636768|NCT01788046|Secondary|Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase|Participants who had no scheduled assessments during the EAP were considered non-responders.|Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set|||percentage of participants|||Number
2636769|NCT01788046|Primary|Percentage of Participants With > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase|Participants who did not have any scheduled assessments during the EAP were considered non-responders.|Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).|The full analysis set, consisting of all randomized participants|||percentage of participants|||Number
2636770|NCT01787916|Secondary|Assessment of Changes on Adipose Tissue|To investigate the effect of 24 weeks of treatment with liraglutide combined with the basal/bolus insulin regimen insulin on adipose tissue|Measure changes in the composite at 24 and 52 weeks from baseline||2017-12-31|12/2017||||
2636771|NCT01787916|Primary|Assessment of Changes in Glycemic Control by HbA1c.|To investigate the effect of 24 weeks of treatment with liraglutide combined with a basal/bolus insulin regimen in overweight participants with type 1 diabetes on glycemic control as assessed by HbA1c.|Measure changes in HbA1c at 24 and 52 weeks from baseline||||percentage of HbA1c||Standard Deviation|Mean
2636772|NCT01787838|Primary|Improving Pneumococcal Vaccination Rates Following Focused Health Education of Staff and Patients|Pneumococcal vaccination rates, tracked biweekly, following 1) staff education, audit and feedback of rates and 2) patient education|12 Months||||participants|||Number
2636773|NCT01787825|Secondary|Preference Between CapsoCam SV-1 and PillCam SB2|Subject preference between CapsoCam SV-1 and PillCam SB2 based on pill preference questionnaire administered to subjects|Study Completion|For CapsoCam SV-1 and PillCam SB2 preference data was captured for 113 subjects.|||participants|||Number
2636774|NCT01787825|Secondary|Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2|Comparison of Diagnostic Yield of CapsoCam SV-1 as compared to PillCam SB: Proportion of primary diagnostic yields based upon the result of 2 out of 3 readers in agreement or the consensus group result.|Study Completion||||participants|||Number
2636775|NCT01787825|Secondary|Comparison of SB Transit Times With CapsoCam SV-1 and PillCam SB2|Total transit time, was determined the time the 1st Duodenal image to the 1st cecal or IC Valve image as determined by the readers.|Study Completion|For CapsoCam SV-1 data was captured for 112 subjects total transit time. For PillCam SB2, data was captured for 110 subjects for total transit time.|||hours||Standard Deviation|Mean
2636776|NCT01787825|Primary|Normal vs Abnormal, Overall Impression|The review of images of suspected diseased small bowel to determine agreement among readers between the two image capture systems: CapsoCam SV-1 and PillCam SB2. The proportion of Normal vs Abnormal, Overall Impression based upon the result of 2 out of 3 data readers in agreement.|Study Completion|Note: Each participant swallowed both Pill Cam and CapsoCam approximately 30-60 minutes apart. the order in which the cams were swalloed was randomized.|||participants|||Number
2636777|NCT01787799|Primary|In-stent Late Loss|In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA)|9 month|The primary endpoint would be considered to have been met if the SYNERGY in-stent late loss was less than the performance goal of 0.40 mm. The Intent To Treat (ITT) and per protocol populations were identical.|||mm||95% Confidence Interval|Mean
2636778|NCT01787760|Primary|Spherical Equivalent Refraction|Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate progression in Myopia.|Baseline and every 6 months post-baseline up to 3 years|Analysis was conducted on all randomized subjects who have at least one data point.|||diopter (D)|eyes|Standard Deviation|Mean
2636779|NCT01787760|Primary|Axial Length (Axial Elongation)|Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision.|Baseline and every 6 months post-baseline up to 3 years|Analysis was conducted on all randomized subjects who have at least one data point.|||millimeter (mm)|eyes|Standard Deviation|Mean
2636780|NCT01787604|Secondary|Survival (Percentage, Kaplan-Meier)|Estimated percentage of alive participants for 4 years after treatment.|up to 4 yeras||||percentage of participants|||Number
2636781|NCT01787604|Primary|Freedom From Aortic Insufficiency More Than 2+ (Percentage, Kaplan-Meier)|Estimated percentage of participants free from aortic insufficiency (AI) more than 2+ measured by echocardiography for a 4 years after treatment..|up to 4 yeras||||percentage of participants|||Number
2636782|NCT01787591|Primary|Estimated Absorption (% Dose)|Absorption of deuterium labelled alpha-tocopherol|0-72 h post-meal||||% dose||Standard Error|Mean
2636783|NCT01787591|Primary|Elimination Rate|Rate of plasma elimination of deuterium labelled alpha-tocopherol|0-72 h post-meal||||mmol/L/h||Standard Error|Mean
2636784|NCT01787591|Primary|Tmax|Time to maximal plasma concentration of deuterium labelled alpha-tocopherol|0-72 h post-meal||||h||Standard Error|Mean
2636785|NCT01787591|Primary|Cmax|Maximal plasma concentration of deuterium labelled alpha-tocopherol|0-72 h post-meal||||umol/L||Standard Error|Mean
2636786|NCT01787591|Primary|Area Under the Curve 0-72 h (Deuterium Labeled Alpha-tocopherol)||0, 3, 6, 9, 12, 24, 36, 48, and 72 h post test meal||||umol/L x h||Standard Error|Mean
2636787|NCT01787552|Secondary|Phase Ib and Phase II: INC424: PK Parameter: Vss/F|Vss/F: Apparent volume of distribution at steady state after oral administration [volume]|0, 0.5, 1. 1.5, 2, 4, 6, 8 hrs on Week 1 Day 1|The Pharmacokinetic Analysis set (PAS) consisted of all subjects in Phase Ib and Phase II who received at least one (full or partial) dose of LDE225 and/or INC424 and provided at least one evaluable PK blood sample for LDE225 and/or INC424.|||Litre (L)||Full Range|Median
2636788|NCT01787552|Secondary|Phase Ib and Phase II: INC424: PK Parameter: T1/2|T1/2: Elimination half-life associated with the terminal slope (lambda_z) of a semi logarithmic concentration-time curve [time]|0, 0.5, 1. 1.5, 2, 4, 6, 8 hrs on Week 1 Day 1|The Pharmacokinetic Analysis set (PAS) consisted of all subjects in Phase Ib and Phase II who received at least one (full or partial) dose of LDE225 and/or INC424 and provided at least one evaluable PK blood sample for LDE225 and/or INC424.|||hour (h)||Full Range|Median
2636789|NCT01787552|Secondary|Phase Ib and Phase II: LDE225: PK Parameter: Racc|Racc: Accumulation ratio calculated as AUC0-12h on Week 9 Day 1 divided by AUC0-12h on Week 1 Day 1 [fold]|0, 0.5, 1. 1.5, 2, 4, 6, 8 hrs on Week 9 Day 1|The Pharmacokinetic Analysis set (PAS) consisted of all subjects in Phase Ib and Phase II who received at least one (full or partial) dose of LDE225 and/or INC424 and provided at least one evaluable PK blood sample for LDE225 and/or INC424.|||ratio||Full Range|Median
2636800|NCT01787552|Secondary|Phase Ib and Phase II: LDE225: Plasma Pharmacokinetics (PK) Parameter: Area Under the Curve(AUC0-24h)|Plasma Concentration Time Curve: AUC0-24h: Area under the concentration-time curve from time zero to 24 hours extrapolate from AUClast[mass x time x volume-1]|0, 0.5, 1. 1.5, 2, 4, 6, 8 hrs on Week 1 Day 1 & Week 9 Day 1|The Pharmacokinetic Analysis set (PAS) consisted of all subjects in Phase Ib and Phase II who received at least one (full or partial) dose of LDE225 and/or INC424 and provided at least one evaluable PK blood sample for LDE225 and/or INC424.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2636790|NCT01787552|Secondary|Phase I and Phase II: Change in EORTC QLQ-C30 Scores From Baseline Compared to Week 24 & Week 48|EORTC QLQ-C30 is the European Organization for Research & Treatment of Cancer, Quality of Life (QoL) Questionnaire & is one of the most widely used & validated instruments to measure health-related QoL in subjects with cancer. The scale includes 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning & social functioning), global health status/QoL & 9 symptom scale/items (fatigue, nausea & vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, & financial difficulties). This instrument asks the subject to respond according to the past week, with the exception of the first 5 questions that represent physical functioning & capture the subject's current status. The range of scores for all of the scales is from 0 to 100. For functional & global health status/QoL scales, higher scores indicate better QoL & level of functioning; for symptom scales, higher scores indicate greater level of symptoms or difficulties.|Week 24, Week 48|The Full Analysis Set (FAS) comprised all subjects in Phase Ib and Phase II who received at least one dose of LDE225 and/or INC424.|||scores on a scale||Standard Deviation|Mean
2636791|NCT01787552|Secondary|Phase Ib and Phase II: Change in Total Symptom Score (TSS) From Baseline to Week 25 & Week 49 Using the MFSAF Total Symptom Scores|The 7-day modified Myelofibrosis Symptom Assessment Form (MFSAF) v2.0 is a 7-item PRO instrument based on the modified MFSAF v2.0 diary administered at specified visits. The first 6 items assess MF symptom severity at its worst as recalled in the 7 days prior to the clinic visit assessment. The symptoms measured include night sweats, itching, abdominal discomfort, pain under the ribs (left side), early satiety, & bone/muscle pain. The 7th item captures MF-related inactivity in the past 7 days prior to the clinic visit assessment. All 7 items ask subjects to record their answers on an 11-point numeric rating scale (NRS), (0 = Absent, 10 = Worst Imaginable). The first 6 items of the instrument focus on MF symptoms & are summed to create a Total Symptom score.|Baseline, Week 25, Week 49|The Full Analysis Set (FAS) comprised all subjects in Phase Ib and Phase II who received at least one dose of LDE225 and/or INC424.|||scores on a scale||Standard Deviation|Mean
2636792|NCT01787552|Secondary|Phase Ib and Phase II: Percentage of Participants With >= 50% Reduction From Baseline in MFSAF Total Symptom Scores|The 7-day modified Myelofibrosis Symptom Assessment Form (MFSAF) v2.0 is a 7-item PRO instrument based on the modified MFSAF v2.0 diary administered at specified visits. The first 6 items assess MF symptom severity at its worst as recalled in the 7 days prior to the clinic visit assessment. The symptoms measured include night sweats, itching, abdominal discomfort, pain under the ribs (left side), early satiety, & bone/muscle pain. The 7th item captures MF-related inactivity in the past 7 days prior to the clinic visit assessment. All 7 items ask subjects to record their answers on an 11-point numeric rating scale (NRS), (0 = Absent, 10 = Worst Imaginable). The first 6 items of the instrument focus on MF symptoms & are summed to create a Total Symptom score.|Week 24, Week 48|The Full Analysis Set (FAS) comprised all subjects in Phase Ib and Phase II who received at least one dose of LDE225 and/or INC424.|||Percentage of participants||95% Confidence Interval|Number
2636793|NCT01787552|Secondary|Phase Ib and Phase ll: Summary of Cytokine Levels in Pharmacodynamic for All Collected Biomarkers|Summary of cytokine levels in Pharmacodynamic Biomarkers for all 26 collected at Week 25 Day 1 and Week 49 Day 1|Baseline, Week 25 Day 1 (Week 24), Week 49 Day 1 (Week 48)|The Biomarker Analysis Set (BAS) consisted of all subjects in Phase Ib and Phase II who received at least one (full or partial) dose of LDE225 and/or INC424 and provided at least one evaluable biomarker sample.|||ng/mL||Full Range|Median
2636794|NCT01787552|Secondary|Phase Ib and Phase ll: Summary of JAK2V617F Allele Burden by Visit and Treatment in Phase Ib and Phase II Stage 1|Phase Ib and Phase ll: Change in Pharmacodynamic Biomarkers: JAK2V617F allele burden|Baseline, Week 25 Day 1 (Week 24), Week 49 Day 1 (Week 48)|The Biomarker Analysis Set (BAS) consisted of all subjects in Phase Ib and Phase II who received at least one (full or partial) dose of LDE225 and/or INC424 and provided at least one evaluable biomarker sample.|||Percentage of JAK allele burden mutation||Full Range|Median
2636795|NCT01787552|Secondary|Phase Ib and Phase II: Percentage of Participants With Fibrosis Grade Assessed by Bone Marrow Histomorphology, by Time and Treatment in Phase Ib and Phase II Stage 1|The number of patients experiencing improvement in their bone marrow fibrosis by at least one grade and assessment of cellularity.|Baseline, Week 25 Day 1 (Week 24), Week 49 Day 1 (Week 48)|The Full Analysis Set (FAS) comprised all subjects in Phase Ib and Phase II who received at least one dose of LDE225 and/or INC424.|||Percentage of Participants|||Number
2636796|NCT01787552|Secondary|Phase Ib and Phase II: LDE225 & INC424:: Plasma Pharmacokinetics (PK) Parameters: Area Under the Curve(CL/F)|CL/F: Apparent total plasma clearance of drug after oral administration [volume x time-1]|0, 0.5, 1. 1.5, 2, 4, 6, 8 hrs on Week 1 Day 1 & Week 9 Day 1|The Pharmacokinetic Analysis set (PAS) consisted of all subjects in Phase Ib and Phase II who received at least one (full or partial) dose of LDE225 and/or INC424 and provided at least one evaluable PK blood sample for LDE225 and/or INC424.|||L/hr||Full Range|Median
2636797|NCT01787552|Secondary|Phase Ib and Phase II: LDE225 & INC424: Plasma PK Parameter: Time to Maximum Plasma Concentration (Tmax)|Tmax: Time to reach Cmax [time]|0, 0.5, 1. 1.5, 2, 4, 6, 8 hrs on Week 1 Day 1 & Week 9 Day 1|The Pharmacokinetic Analysis set (PAS) consisted of all subjects in Phase Ib and Phase II who received at least one (full or partial) dose of LDE225 and/or INC424 and provided at least one evaluable PK blood sample for LDE225 and/or INC424.|||hour (hr)||Full Range|Median
2636798|NCT01787552|Secondary|Phase Ib and Phase II: LDE225 & INC424: PK Parameter: Maximum Plasma Concentration (Cmax)|"Cmax: Maximum observed plasma concentration after drug administration [mass x volume-~1]."|0, 0.5, 1. 1.5, 2, 4, 6, 8 hrs on Week 1 Day 1 & Week 9 Day 1|The pharmacokinetic analysis set (PAS) consisted of all subjects in Phase Ib and Phase II who received at least one (full or partial) dose of LDE225 and/or INC424 and provided at least one evaluable PK blood sample for LDE225 and/or INC424.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2636799|NCT01787552|Secondary|Phase Ib and Phase II: INC424: PK Parameters: Area Under the Curve for AUC0-12h, AUCinf & AUClast|AUC0-12h: Area under the concentration-time curve from time zero to 12 hours extrapolate from AUClast[mass x time x volume-1]. AUCinf: Area under the concentration-time curve from time zero to infinity with extrapolation of the terminal phase [mass x time x volume-1]. AUClast: Area under the concentration-time curve from time zero to the time of last measurable concentration [mass x time x volume-1].|0, 0.5, 1. 1.5, 2, 4, 6, 8 hrs on Week 1 Day 1 & Week 9 Day 1|The Pharmacokinetic Analysis set (PAS) consisted of all subjects in Phase Ib and Phase II who received at least one (full or partial) dose of LDE225 and/or INC424 and provided at least one evaluable PK blood sample for LDE225 and/or INC424.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2636801|NCT01787552|Primary|Percentage of Patients Achieving >= 35% Reduction in Spleen Volume in Phase Ib Expansion and Phase II Stage 1|Reduction in spleen volume as measured by magnetic resonance imaging/Cat Scan (MRI/CT) in Phase Ib expansion and Phase II Stage 1 patients|Week 24 and Week 48|The Full Analysis Set (FAS) comprised all subjects in Phase Ib and Phase II who received at least one dose of LDE225 and/or INC424. The data disclosed includes only participants from Phase Ib dose expansion phase and Ph II Stage 1. This data does not include dose escalation Phase Ib participants.|||Percentage of Participants|||Number
2636802|NCT01787552|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) (Phase 1b)|A dose-limiting toxicity (DLT) was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.|6 weeks (42 days)|Safety Analysis Set (SAS) included all participants in Phase Ib & Phase II who received at least 1 dose of LDE225 and/or INC424 & had at least 1 valid post-baseline safety assessment. DLT was measured in the Phase Ib dose escalation & expansion phase, as part of the primary outcome. All participants in the safety set were considered for toxicities.|||Participants|||Count of Participants
2636803|NCT01787461|Secondary|Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode)|Skin density was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system with 100 percent (%) calibration mode. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).|Baseline, Week 6, 12, 18, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."|||micrometer||Standard Deviation|Mean
2636804|NCT01787461|Secondary|Change From Baseline in Skin Thickness at Week 6, 12,18 and 24|Skin thickness was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).|Baseline, Week 6, 12, 18, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time ­points for each arm, respectively."|||micrometer||Standard Deviation|Mean
2636805|NCT01787461|Secondary|Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24|Trans-epidermal water loss (TEWL) measurements were done using DermaLab Combo SkinLab with a cylindrical diffusion chamber (10 mm [millimeter] diameter) containing 2 combined humidity/temperature sensors to determine the amount of water vapor that moves across the stratum corneum. TEWL measurements were taken on the left cheek and the left inner and outer arm (up to 3 measurement).|Baseline, Week 6, 12, 18, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."|||gram per square meter per hour||Standard Deviation|Mean
2636806|NCT01787461|Secondary|Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24|DermaLab Combo Skin Lab with an 8-pin probe was used to measure hydration (corneometry). Hydration measurements of the left cheek, left inner arm, and left outer arm were taken (up to 3 measurement).|Baseline, Week 6, 12, 18, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."|||microsecond||Standard Deviation|Mean
2636807|NCT01787461|Secondary|Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24|Participants performed the assessment of decolletage (decolletage overall, decolletage-wrinkling/crinkling (W/C), decolletage-discoloration (DD) and back of hands (back of hands overall, back of hands (BOH) - Fine lines/wrinkles (L/W), back of hands - discoloration) and Body - Dryness (BD) Overall at baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the Decolletage, Back of Hands and Body parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).|Baseline, Week 12, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."|||units on scale||Standard Deviation|Mean
2636808|NCT01787461|Secondary|Participants Improvement Assessment of Face at Week 12 and 24|Participants performed the assessment of face (overall facial (OA) appearance, fine lines and wrinkles (L/W) present in the eye area, upper lip, or cheek areas, under eye dark circles (dc) or bags, discoloration [uneven, patchy, blotchy areas of light and dark, age spots, liver spots], complexion/glow [bright radiant appearance] and smoothness) at Baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the facial parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).|Baseline, Week 12, 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."|||units on scale||Standard Deviation|Mean
2636809|NCT01787461|Secondary|Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24|Investigator performed the assessment of decolletage and back of hands (crepyness, mottled hyperpigmentation [MH]) using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.|Baseline, Week 12, 24|"Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time ­points for each arm, respectively."|||units on scale||Standard Deviation|Mean
2637471|NCT01781975|Secondary|Change in HbA1c Levels Over Time|Change in HbA1c levels from Week 52 to Week 104|Visit 9 (Week 52) and Visit 13 (Week 104)||||percentage of HbA1c level||95% Confidence Interval|Mean
2636810|NCT01787461|Secondary|Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24|"Investigator performed the assessment of face (Fine lines/wrinkles (L/W) of the periocular area (A), Fine lines/wrinkles of the perioral area, dark circles (dc) or bags under the eye, mottled hyperpigmentation (MH), sallowness/yellowing, roughness/texture) using a numerical severity rating scale of 0 to 9, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe."|Baseline, Week 12, 24|"Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."|||units on scale||Standard Deviation|Mean
2636811|NCT01787461|Secondary|Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12|IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.|Baseline, Week 12|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."|||units on scale||Standard Deviation|Mean
2636812|NCT01787461|Secondary|Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24|IPRC assessment was performed in accordance with the Canfield procedures and rated the improvement relative to Baseline. The investigators used an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).|Week 24|"m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||units on scale||Standard Deviation|Mean
2636813|NCT01787461|Primary|Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24|IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.|Baseline, Week 24|"Modified intent-to-treat (m-ITT) population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here n signifies those participants who were evaluable for this measure at specified time­ points for each arm, respectively."|||units on scale||Standard Deviation|Mean
2636814|NCT01787383|Secondary|Convenience TSQM|Convenience TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived convenience with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).|8 weeks||||units on a scale||Standard Deviation|Mean
2636815|NCT01787383|Secondary|Global Satisfaction TSQM|Global Satisfaction TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived overall satisfaction with medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).|8 weeks||||units on a scale||Standard Deviation|Mean
2636816|NCT01787383|Secondary|Side Effects TSQM|Side Effects TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived side effects of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).|8 weeks||||units on a scale||Standard Deviation|Mean
2636817|NCT01787383|Secondary|Effectiveness Satisfaction Questionnaire for Medication (TSQM)|Effectiveness TSQM After a Treatment Cycle of 8 Weeks. Measurement of the perceived effectiveness of medication, ranging from 0 (worst possible outcome) to 100 (best possible outcome).|8 weeks||||units on a scale||Standard Deviation|Mean
2636818|NCT01787383|Secondary|Percent Reduction in Number of AKs in Each Separate Treatment Area 8 Weeks After Treatment|"Percent reduction in number of Actinic Keratosis lesions (AKs) analysed for each separate treatment area and presented by treatment regimen. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together Per Arm (e.g. averaged)."|8 weeks after treatment||||percentage reduction in number of AKs||Standard Deviation|Mean
2636819|NCT01787383|Secondary|Partial Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment|"Partial clearance of Actinic Keratosis lesions (AKs) defined as 75% or greater reduction in Actinic Keratosis lesions (AKs) from start of treatment to 8 weeks after treatment, was analysed in each separate treatment area and presented by treatment regimen given as percentage of participatns with complete AK clearance. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together Per Arm (e.g. averaged)."|8 weeks after treatment||||percentage of participants|||Number
2636820|NCT01787383|Secondary|Complete Clearance of AKs in Each Separate Treatment Area 8 Weeks After Treatment|"Complete clearance of Actinic Keratosis lesions (AKs) analysed in each separate treatment area and presented by treatment regimen given as percentage of participants with complete AK clearance. Each subject could contribute with up to 2 values (1 for each treated area). Both affected areas were calculated together Per Arm (e.g. averaged)."|8 weeks after treatment||||percentage of participants|||Number
2636821|NCT01787383|Primary|Composite Local Skin Reaction (LSR) Score 3 Days After Treatment of Each Selected Treatment Area|"Composite Local Skin Reaction (LSR) score 3 days after treatment of each selected treatment area in both treatment groups (simultaneous or sequential). The composite LSR score (0 to 24), reflecting the sum of the individual LSR grades (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration, grade 0 to 4), was calculated for each selected treatment area at each visit.The composite LSR score ranges from 0 (best possible outcome) to 24 (worst possible outcome). Both affected areas were calculated together Per Arm. Each subject could contribute with up to 2 values (1 for each treated area)."|3 days after treatment of each selected treatment area||||units on a scale||Standard Deviation|Mean
2636822|NCT01787331|Secondary|Mean Steady-state Trough Level of Hydroxy-itraconazole|Descriptive statistics including the mean, standard deviation, and range of steady-state trough serum levels of itraconazole and its active metabolite hydroxy-itraconazole will be determined.|Up to 4 weeks|No data collected||||||
2636823|NCT01787331|Secondary|Mean Steady-state Trough Level of Serum Itraconazole|Descriptive statistics including the mean, standard deviation, and range of steady-state trough serum levels of itraconazole and its active metabolite hydroxy-itraconazole will be determined.|Up to 4 weeks|No data collected||||||
2636824|NCT01787331|Secondary|Percentage of Participants With Treatment-related, Clinical Laboratory Adverse Events|All patients who receive at least one dose of study drug will be analyzed for safety endpoints. All adverse events will be graded and classified according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 4.. Percentage of patients with grade 1 or higher, treatment-related adverse events based on the following labs will be reported: potassium, sodium, alkaline phosphatase, total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), Hematocrit, Hemoglobin, platelets, white blood cells, atypical lymphs, basophils, eosinophils, monocytes, neutrophils, blood urea nitrogen, and creatinine.|Up to 2 years||||percentage of participants|||Number
2636825|NCT01787331|Secondary|Percentage of Participants With Treatment-related, Adverse Changes in Vital Signs|All patients who receive at least one dose of study drug will be analyzed for safety endpoints. All adverse events will be graded and classified according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v. 4. Percentage of patients with grade 1 or higher, treatment-related adverse events based on the following vital sign assessments will be reported: blood pressure, pulse, respiration rate and temperature.|Up to 2 years||||percentage of participants|||Number
2636826|NCT01787331|Secondary|Median Metastasis-free Survival|The probability distribution of the time to first metastasis will be estimated using the Kaplan-Meier product limit method measured from the time of start of protocol therapy. The results will be summarized by the estimated median with 95% confidence intervals.|Up to 2 years|Data not collected||||||
2636827|NCT01787331|Secondary|Median Time to Clinical Progression|"Clinical progression will be defined as the first occurrence of either the development of metastases or initiation of non-protocol therapy, and will exclude PSA-only progression.~The probability distribution of the time to clinical progression will be estimated using the Kaplan-Meier product limit method measured from the time of start of protocol therapy. The results will be summarized by the estimated median with 95% confidence intervals."|Up to 2 years|Only 1 patient displayed clinical progression|||months||Full Range|Median
2636828|NCT01787331|Secondary|Median Time to PSA Progression|PSA progression defined as: 1. If no PSA decline is observed on therapy, PSA progression will be defined as an increase in serum PSA > 50% above the baseline PSA, and an absolute increase of > 2 ng/mL above baseline, confirmed by repeat measurement at least 2 weeks later. 2. If PSA declines on therapy, PSA progression will be defined as an increase in serum PSA > 50% above the nadir PSA on therapy, and an absolute increase > 2 ng/mL above the nadir, confirmed by repeat measurement at least 2 weeks later. The probability distribution of the time to PSA progression will be estimated using the Kaplan-Meier product limit method measured from the start of protocol therapy. The results will be summarized by the estimated median with 95% confidence intervals.|Up to 2 years||||months||Full Range|Median
2636829|NCT01787331|Secondary|Mean Percent Change in PSA Doubling Time|The mean percent change in PSA doubling time from pre-treatment to after 12 weeks of protocol therapy|Up to 12 weeks||||Percent change in PSA doubling time||Full Range|Mean
2636830|NCT01787331|Primary|Number of Patients Who Achieve a Greater Than or Equal to 50% Decline in Serum Prostate Specific Antigen (PSA)|The number of patients with biochemically relapsed disease after prior definitive local therapy who achieve a ≥ 50% decline from baseline in serum PSA after 12 weeks of therapy with itraconazole, confirmed by repeat measurement at least 2 weeks later.|At 12 weeks after start of treatment||||Participants|||Count of Participants
2636831|NCT01787292|Secondary|Heart Rate Workload After Home Based Intervention|"Measured heart rate after home based intervention~Technical implementation at the facility level prevented acquisition of these metrics until late in the project."|24 and 48 weeks|Participants completing home based interventions compared to facility based interventions - measured in time in aerobic zone.|||percentage of time||Standard Deviation|Mean
2636832|NCT01787292|Secondary|Target Heart Rate Zone After Aerobic Exercise First|Targeted Heart Rate Zone among participants compared among short term exercise groups|24 and 48 weeks||||percentage of time||Standard Deviation|Mean
2636833|NCT01787292|Secondary|Target Heart Rate Zone for Balance First Participants|Heart rate in aerobic target zone is measured in percentage of time in at least 50% of participants heart rate reserve.|24 and 48 weeks||||percentage of time||Standard Deviation|Mean
2636834|NCT01787292|Primary|Comparison of Silent Period Duration After Balance Exercise|Comparison of Home based training effects on TMS measures of silent period duration as compared to facility based exercise programs.|24 and 48 weeks|Participants completing balance training then crossing over into aerobic exercise were then tested for effects of facility based treatments against home exercise.|||milliseconds||Standard Deviation|Mean
2636835|NCT01787292|Primary|Comparison of Silent Period Duration After Aerobic Exercise|Comparison of silent period duration at 24 weeks compared to baseline|Baseline, 12 weeks, 24 weeks||||milliseconds||Standard Deviation|Mean
2636836|NCT01787292|Primary|Comparison of Cardiovascular Efficiency for Balance Exercise First Group After Home-based Intervention|VO2peak estimation completed using the YMCA protocol investigating overall volume of oxygen consumption as a function of heart rate during work loads.|24 and 48 weeks|Participants completed both exercise interventions but completed Balance training prior to engaging in aerobic exercise training.|||ml/kg(min)||Standard Deviation|Mean
2636837|NCT01787292|Primary|Comparison of Cardiovascular Efficiency for Aerobic Exercise First Group After Home-based Intervention|Comparison of home based aerobic exercise intervention to assessments made after completion of crossover intervention in Participants receiving aerobic condition first. VO2peak estimation completed using the YMCA protocol investigating overall volume of oxygen consumption as a function of heart rate during work loads. Estimated VO2 peak values are in ml/kg(min).|24 and 48 weeks||||ml/kg(min)||Standard Deviation|Mean
2636838|NCT01787292|Primary|fMRI Interhemispheric Inhibition Improvement After Balance Training|Area under the curve of fMRI measures of right motor cortex BOLD profile will remain similar to pre measurements. The BOLD profile is the z-normalized area under the curve value of the fMRI impulse response function. A higher number indicates less interhemispheric inhibition.|Baseline, 12 weeks, 24 weeks||||Z-transformed impulse response function||Standard Deviation|Mean
2636885|NCT01787006|Secondary|Rate of Participants Who Were Alive Without Progression of Disease at 2 Years|For progression-free survival (PFS), the event was defined as first occurrence of radiologically proven progression or clinical progression or death due to progressive disease. Time to event was referenced from the day of randomization.|2 years||||percentage of participants||95% Confidence Interval|Number
2636839|NCT01787292|Primary|fMRI Interhemispheric Inhibition Improvement After Aerobic Exercise|Participants who exercise will evidence larger increases in interhemispheric inhibition as assessed by functional magnetic resonance measured by a z-normalized area under curve of right primary motor cortex. The area under the curve is an estimate of the fMRI hemodynamic response impulse response function. A higher number of AUC indicates less interhemispheric inhibition. In contrast, a lower number in this analysis indicates higher interhemispheric inhibition.|Baseline to 24 Weeks with cross-over|Analysis of area under curve of right primary motor cortical area|||Z-transformed impulse response function||Standard Deviation|Mean
2636840|NCT01787292|Primary|Silent Period Duration for Balance Group|Ipsilateral silent period duration as assessed by TMS|Baseline, 12 weeks, 24 weeks|Sedentary older adults engaging in less than 45 minutes of total activity per week|||milliseconds||Standard Deviation|Mean
2636841|NCT01787292|Primary|Silent Period Duration After Exercise Cycling Program|Duration of ipsilateral silent period from Transcranial magnetic stimulation measured in milliseconds|Baseline, 12 weeks, 24 weeks||||milliseconds||Standard Deviation|Mean
2636842|NCT01787292|Primary|Estimate of Cardiovascular Efficiency After Balance Training|Estimated VO2peak using YMCA cycle test completed over nine to twelve minutes.|Baseline, 12 weeks, 24 weeks|Sedentary older adults who engaged in less than 45 minutes of regular exercise per week|||ml/kg(min)||Standard Deviation|Mean
2636843|NCT01787292|Primary|Estimate Cardiovascular Efficiency After Aerobic Exercise|Estimate of Volume of oxygen consumption (VO2peak) using YMCA protocol for cardiovascular assessment.|Baseline, 12 weeks, 24 weeks|Estimated VO2 peak values in ml/kg(min)|||ml/kg(min)||Standard Deviation|Mean
2636844|NCT01787279|Secondary|Percentage of Participants Achieving Combined Response Hepatitis B Virus DNA < 10,000 Copies/mL and Normal ALT at Week 72|Percentage of participants showing normal ALT values and HBV DNA levels <10,000 copies/ mL were reported.|At Week 72|ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment. Participants available at the time of assessment were included in the analysis.|||Percentage of participants|||Number
2636845|NCT01787279|Secondary|Percentage of Participants Achieving Hepatitis B Surface Antigen Seroconversion at Screening and Week 48|Seroconversion is defined as the absence of hepatitis B surface antigen (HBsAg) with a negative result for HBsAg and the presence of anti-Haemoglobin (HBs) antibodies (a positive result for anti-HBs) determined at Week 48. Blood samples were analyzed to check whether it is HBsAg-negative and anti-HBs antibodies positive.|At Screening and Week 48|ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment. ‘n’=number of evaluable participants available at specified time point.|||Percentage of participants|||Number
2636846|NCT01787279|Secondary|Percentage of Participants Achieving Hepatitis B Virus DNA < 400 Copies/mL at Week 72|Participants who had HBV-DNA levels below 400 Copies/mL at the end of follow-up (at Week 72) were reported.|At Week 72|ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment.|||Percentage of participants||95% Confidence Interval|Number
2636847|NCT01787279|Primary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above|Up to Week 72|Safety analysis population is defined to include only participants who receive at least one dose of study medication and have one subsequent post baseline safety assessment.|||Participants|||Number
2636848|NCT01787279|Primary|Percentage of Participants Achieving Normalization of Alanine Aminotransferase at Week 72|Percentage of participants with a normal serum alanine aminotransferase (ALT) level at the end of the study was analyzed. Normal ranges for ALT are 7 to 56 International Units/Litre. Participants with ALT less than the upper limit of normal at end of treatment were reported.|At Week 72|ITT population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment.|||Percentage of participants||95% Confidence Interval|Number
2636849|NCT01787279|Primary|Percentage of Participants Achieving Hepatitis C Virus Deoxyribonucleic Acid <10,000 Copies/Milliliter at Week 72|Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (at Week 72) were reported.|At Week 72|Intent-to-treat (ITT) population included all the participants who received at least one dose of study medication and had one subsequent post baseline assessment.|||Percentage of participants||95% Confidence Interval|Number
2636850|NCT01787240|Other Pre-specified|Effects of Acute Tryptophan Depletion on Serotonin Binding|"We will examine percentage changes in serotonin binding potential before and after acute tryptophan depletion within each region of interest. We will examine differences in serotonin binding potential between placebo responders and drug responders using a paired two-tailed t-test.~Data were not collected"|Visit 5 (after 4 weeks in study) or Visit 10 (after 9 weeks in study)|Data were not collected||||||
2636851|NCT01787240|Secondary|Effects of Acute Tryptophan Depletion on Mood|"We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests.~The HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression.~A negative change value refers to a decrease in HAM D score."|Baseline, Visit 5 (4 weeks into study)|Patients who were randomized to take placebo or active drug|||units on a scale||Standard Deviation|Mean
2636886|NCT01787006|Secondary|Rate of Participants Who Were Alive Without Progression of Disease at 1 Year|For progression-free survival (PFS), the event was defined as first occurrence of radiologically proven progression or clinical progression or death due to progressive disease. Time to event was referenced from the day of randomization.|1 year||||percentage of participants||95% Confidence Interval|Number
2636852|NCT01787240|Secondary|Effects of Acute Tryptophan Depletion on Mood|"We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests.~The HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression.~A negative change value refers to a decrease in HAM D score."|Baseline, Visit 10 (after 9 weeks in study)|Participants assigned to take either active drug or placebo who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2.|||units on a scale||Standard Deviation|Mean
2636853|NCT01787240|Primary|Feasibility|We will measure the percentage of screened eligible patients who agree to be randomized. Participants were assessed for this Outcome Measure before randomization.This would occur at the first study visit (screening).|This would occur at the first study visit (screening).||||percent of eligible patients|||Number
2636854|NCT01787188|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.|"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.~The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC stiffness subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2636855|NCT01787188|Secondary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.|"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.~The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 12/early termination minus the WOMAC stiffness subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2636856|NCT01787188|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.|"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.~The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 6 minus the WOMAC stiffness subscale score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2636857|NCT01787188|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score.|"The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness.~The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 2 minus the WOMAC stiffness subscale score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2636858|NCT01787188|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.|"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.~The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC function subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2636873|NCT01787032|Secondary|Terminal Half-life of BI 113608 in Plasma (t1/2)|This outcome measure presents terminal half-life of BI 113608 in plasma.|1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.|Pharmacokinetic Set (PKS): The ‘PK set’ included all subjects of the treated set who provided at least one evaluable observation for at least one primary PK endpoint in at least one treatment period without important protocol violations relevant to the evaluation of PK; PK analyses were based on the PK set.|||hours (h)||Geometric Coefficient of Variation|Geometric Mean
2636859|NCT01787188|Secondary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.|"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.~The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 12/early termination minus the WOMAC function subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2636860|NCT01787188|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.|"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.~The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 6 minus the WOMAC function subscale score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2636861|NCT01787188|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score.|"The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation.~The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 2 minus the WOMAC function subscale score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2636862|NCT01787188|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total (composite) WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total WOMAC score difference was calculated as the total WOMAC score assessed at Weeks 2, 6, and 12 minus the total WOMAC score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2636863|NCT01787188|Secondary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 12/early termination minus the total WOMAC score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2636864|NCT01787188|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 6 minus the total WOMAC score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2636883|NCT01787006|Secondary|Rate of Participants Who Were Alive Without Distant Metastases at 1 Year|For metastases-free survival (MFS), the event was defined as first occurrence of distant metastasis. Time to event was referenced from the day of randomization.|1 year||||percentage of participants||95% Confidence Interval|Number
2641623|NCT01744392|Secondary|Blood Pressure at 6 Months|Clinical Characteristics at 6 months for Systolic & Diastolic Blood Pressure,|6 months||||mmHg||Standard Deviation|Mean
2636865|NCT01787188|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 2 minus the total WOMAC score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2636866|NCT01787188|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2636867|NCT01787188|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 6 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2636868|NCT01787188|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 2 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2636869|NCT01787188|Primary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2636870|NCT01787175|Secondary|Identification of Planned Monitoring and Follow up Encounters in Assessment and Plan|Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan. . The secondary outcome evaluated participants' recommendation about future monitoring of patient conditions. Participants reviewed a total of 10 patient cases and received a score of 0 or 1 point for each issue within each case. The final score for each participant was a proportion between 0 and 1. The proportion represented the sum of all points assigned to the participant, divided by the total number of points possible. Higher values on the scale represent a greater proportion of appropriate monitoring recommendations made.|10 minutes||||proportion||95% Confidence Interval|Mean
2636871|NCT01787175|Primary|Accuracy of Written Assessment and Plan in Terms of Control and Status|Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan. The primary outcome evaluated participants' recommendations for treatment of patient conditions. Participants reviewed a total of 10 patient cases and received a score between 0 and 3 points for each issue within each patient case. The final score for each participant was a proportion between 0 and 1. The proportion represented the sum of all points assigned to the participant, divided by the total number of points possible. Higher values on the scale represent greater accuracy of the written assessment and plan.|10 minutes||||units on a scale||95% Confidence Interval|Mean
2636872|NCT01787175|Primary|Amount of Time to Complete Assessment and Plan|Each participant had 10 minutes maximum to review the patient case and write an Assessment and Plan.|10 minutes|58 providers were enrolled|||minutes||Standard Deviation|Mean
2636884|NCT01787006|Secondary|Number of Participants Experiencing at Least One Grade >=3 Toxicity|Toxicity was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) (version 4.03).|up to 2 years||||Participants|||Count of Participants
2636874|NCT01787032|Secondary|Time From Dosing to Maximum Measured Concentration of BI 113608 in Plasma (Tmax)|This outcome measure presents time from dosing to maximum measured concentration of BI 113608 in plasma.|1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.|Pharmacokinetic Set (PKS): The ‘PK set’ included all subjects of the treated set who provided at least one evaluable observation for at least one primary PK endpoint in at least one treatment period without important protocol violations relevant to the evaluation of PK; PK analyses were based on the PK set.|||hours (h)||Geometric Coefficient of Variation|Geometric Mean
2636875|NCT01787032|Secondary|Area Under the Concentration-time Curve of BI 113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)|"This outcome measure presents area under the concentration-time curve of BI 113608 in plasma over the time interval from 0 to infinity.~The parameter dispersion type (standard deviation) is actually intra individual geometric coefficient of variation (intraindividual gCV).~Statistical analysis 1: The ratio (Other) is calculated as BI + K (T1): BI (R) [%]. Statistical analysis 2: The ratio (Other) is calculated as BI + V (T2): BI (R) [%]."|1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.|Pharmacokinetic Set (PKS): The ‘PK set’ included all subjects of the treated set who provided at least one evaluable observation for at least one primary PK endpoint in at least one treatment period without important protocol violations relevant to the evaluation of PK; PK analyses were based on the PK set.|||nanomol*hours/litre (nmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2636876|NCT01787032|Primary|Maximum Measured Concentration of BI 113608 in Plasma (Cmax)|"This outcome measure presents the maximum measured concentration of BI 113608 in plasma.~The parameter dispersion type (standard deviation) is actually intra individual geometric coefficient of variation (intraindividual gCV).~Statistical analysis 1: The ratio (Other) is calculated as BI + K (T1): BI (R) [%]. Statistical analysis 2: The ratio (Other) is calculated as BI + V (T2): BI (R) [%]."|1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.|Pharmacokinetic Set (PKS): The ‘PK set’ included all subjects of the treated set who provided at least one evaluable observation for at least one primary PK endpoint in at least one treatment period without important protocol violations relevant to the evaluation of PK; PK analyses were based on the PK set.|||nanomol/litre (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2636877|NCT01787032|Primary|Area Under the Concentration-time Curve of BI 113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|"This outcome measure presents the area under the concentration-time curve of BI 113608 in plasma over the time interval from 0 to the last quantifiable data point.~The parameter dispersion type (standard deviation) is actually intra individual geometric coefficient of variation (intraindividual gCV).~Statistical analysis 1: The ratio (Other) is calculated as BI+K (T1): BI (R) [%]. Statistical analysis 2: The ratio (Other) is calculated as BI + V (T2): BI (R) [%]."|1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.|Pharmacokinetic Set (PKS): The ‘PK set’ included all subjects of the treated set who provided at least one evaluable observation for at least one primary PK endpoint in at least one treatment period without important protocol violations relevant to the evaluation of PK; PK analyses were based on the PK set.|||nanomol*hours/litre (nmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2636878|NCT01787006|Secondary|Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)|"Quality of Life was assessed with EORTC QLQ-C30 and QLQ-OES18 questionnaires. For QLQ-C30, global health status, functional scales (physical, role, emotional, cognitive and social functioning) and symptom scales (fatigue, nausea/vomiting, pain, dyspnea, loss of appetite, constipation, diarrhea, financial difficulties) were calculated. Scores ranged from 0 to 100; higher scores represented higher levels of quality of life, functioning, or symptoms/problems. Score were calculated using mean values.~For QLQ-OES18, symptom scales (problems with eating, reflux, pain, problems swallowing saliva, dry mouth, taste disorders, problems while coughing or speaking) and functional scale (dysphagia) were assessed the same way.~A change between two time points, i.e. baseline (prior to treatment) and end of treatment (after 5 to 13 weeks, depending on treatment arm (6.5 weeks without and 13 weeks with cetuximab) and achievement of resectability (end of treatment after 5 weeks), is reported."|end of treatment (after 5 to 13 weeks)|"All scales used for the rows below in the outcome measure data table ranged between 0 and 100.~For scales indicated [H], a higher score represents a better situation (quality of life, functioning).~For scales indicated [L], a lower value represents a better outcome (symptoms/problems)."|||score on a scale||Standard Deviation|Mean
2636879|NCT01787006|Secondary|Rate of Participants Who Were Alive Without Loco-regional Failure at 2 Years|Loco-regional failure was defined as progressive primary tumor and/or regional lymph nodes on endoscopy, endoscopic ultrasound or computed tomography. Time to event was referenced from the day of randomization.|2 years||||percentage of participants||95% Confidence Interval|Number
2636880|NCT01787006|Secondary|Rate of Participants Who Were Alive Without Loco-regional Failure at 1 Year|Loco-regional failure was defined as progressive primary tumor and/or regional lymph nodes on endoscopy, endoscopic ultrasound or computed tomography.Time to event was referenced from the day of randomization.|1 year||||percentage of participants||95% Confidence Interval|Number
2636881|NCT01787006|Secondary|Number of Participants Who Achieved at Least Partial Response (Responders)|"Response was defined according to the RECIST criteria (Version 1.1) based on the assessments (computed tomography, magnetic resonance imaging or other) for target lesions, non-target lesions as well as considering the occurrence of new lesions.~The best overall response (RECIST) was chosen for each patient out of all valid tumour assessments before start of next-line therapy (complete response=CR being the best and progressive disease=PD the worst). Frequencies with percentages were to be given for each category (CR, partial response (PR), stable disease (SD), PD) by treatment group. The data were to be presented as the dichotomous endpoint of objective response, for which patients with best overall response of CR or PR were considered as responders, and those with best overall response of SD or PD as non-responders. The difference between objective response rates in the two treatment arms was to be compared with a Chi-square test."|up to 2 years||||Participants|||Count of Participants
2636882|NCT01787006|Secondary|Rate of Participants Who Were Alive Without Distant Metastases at 2 Years|For metastases-free survival (MFS), the event was defined as first occurrence of distant metastasis. Time to event was referenced from the day of randomization.|2 years||||percentage of participants||95% Confidence Interval|Number
2636888|NCT01787006|Primary|Rate of Participants Who Were Alive at 2 Years|Overall Survival (OS) was defined as freedom from death of any cause. Time to death was calculated from the day of randomization, and the patients were followed for a maximum of 24 months (2 years).|2 years||||percentage of participants||95% Confidence Interval|Number
2636889|NCT01786993|Primary|Percentage of Non-responders With MPP Compared to Biventricular Pacing|"The hypothesis is that the non-response rate to CRT therapy in the MPP therapy arm is not inferior to the non-response rate in the BiV arm between 3 and 9 months post-implant. Responder status was assessed using the Clinical Composite Score (CCS). A patient's CCS was classified as worsened, improved or unchanged based on the definitions below:~Worsened - patient died due to cardiovascular reasons, experienced a HF event, demonstrated worsening in NYHA class, or had worsening of PGA score compared to the last observation~Improved - patient survived without a HF event, and demonstrated either improvement in NYHA class or improvement in PGA score, or both compared to the last observation.~Unchanged - patient was neither improved nor worsened~For patients who were responders at the 3-month visit, those who were Improved and Unchanged between 3 and 9 months were classified as responders, whereas those who were Worsened were grouped together as non-responders."|3 months to 9 months||||percentage of patients|||Number
2636890|NCT01786993|Primary|Freedom From System-related Complications Through 9 Months Compared to an Objective Performance Criterion|A system related complication is a complication related to the Quadripolar CRT-D device system which includes pulse generator and leads, as adjudicated by an independent Clinical Events Committee (CEC). All subjects who had an attempted implant or a successful Quadripolar system implant were included in the analysis of this safety endpoint.|Implant to 9 months|Of 469 subjects who underwent an attempted implant, 31 subjects experienced a system-related complication between implant and 9 months (13 were LV lead-related, 16 were RA/RV lead-related and 3 were Quadripolar CRT-D pulse generator related. One subject experienced more than one category of complication).|||Event-Free Probability||95% Confidence Interval|Number
2636891|NCT01786967|Secondary|Percentage With Moderate to Severe Anticipated Drug Associated Adverse Events|Outcome was defined as moderate to severe anticipated adverse events (AE) based on the NCI Common Terminology Criteria for Adverse Events (CTCAE). Each AE is graded 1-5 with Grade 1=mild AE, Grade 2=moderate AE, Grade 3=severe AE, Grade 4=life-threatening or disabling AE, grade 5=Death-related to AE. Any side effect grade >= 2 considered a moderate to severe AE. Anticipated AEs included dizziness, somnolence, insomnia, confusion, cognitive impairment, dry eyes, blurry vision, dry mouth, constipation, nausea, dyspepsia and urinary retention. Example: dry mouth grades per CTCAE: Grade 1=symptomatic without significant dietary alteration; unstimulated saliva flow > 0.2 mL/min; Grade 2=symptomatic and significant oral intake alteration; unstimulated saliva flow 0.1 to 0.2 mL/min; Grade 3=symptoms leading to inability to adequately aliment orally; IV fluids, tube feedings or total parenteral nutrition indicated; unstimulated saliva < 0.1 mL/min.|4 weeks|Extensive and poor metabolizers are the two cohorts being compared. These cohorts were determined based on their CYP2D6 sequence. Only 58 subjects have data as 3 participants' sequencing did not yield a definitive metabolizer status.|||percentage of participants|||Number
2636892|NCT01786967|Primary|Percentage With Treatment Success|"Treatment Success (Yes/No) was defined by the Treatment Benefit Scale (TBS). TBS is a 4-point scale which was dichotomized into Yes/No for the Treatment Success outcome. The scale asks participants to rate My condition has been improved: 1= greatly improved, 2=improved, 3=not changed, 4= worsened. If a participant responded 1 (greatly improved) or 2 (improved), they were considered as a Yes for Treatment Success. If a participant responded 3 (not changed) or 4 (worsened), then they were considered as a No for Treatment Success."|4 weeks|Extensive and poor metabolizers are the two cohorts being compared. These cohorts were determined based on their CYP2D6 sequence. Only 58 subjects have data as 3 participants' sequencing did not yield a definitive metabolizer status.|||percentage of participants|||Number
2636893|NCT01786954|Secondary|Adverse Events|The secondary outcome is the onset of any adverse events related to measurement of intraocular pressure.|postoperative day #1|Adverse events were analyzed for all enrolled patients, in contrast to IOP measurements, which were only analyzed for the 50 post-vitrectomy patients.|||adverse events|||Number
2636894|NCT01786954|Primary|Measurement of Intraocular Pressure|The primary outcome is the measurement of intraocular pressure on postoperative day #1 following vitreoretinal surgery.|postoperative day #1|Of the 68 patients enrolled, only 50 patients who received IOP measurement one day following vitrectomy surgery were analyzed. Those with IOP measurement following non-vitrectomy surgery were subsequently excluded from the analysis.|||mm Hg||Standard Deviation|Mean
2636895|NCT01786902|Other Pre-specified|Changes in Anti-growth Hormone Antibody||baseline and 26 weeks||||ng/mL||Standard Deviation|Mean
2636896|NCT01786902|Secondary|Changes in Height Standard Deviation Score After 26 Weeks|The Height Standard Deviation Score was calculated as height minus reference mean height divided by the standard deviation of the reference mean height, both given by a reference growth table for the corresponding chronological age at the height measurement. Greater Height Standard Deviation Score indicates greater height.|26 weeks||||ratio||Standard Deviation|Mean
2636897|NCT01786902|Primary|Annualized Height Velocity(cm/Year) After 26 Weeks|Height Velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.|26 weeks||||cm/year||Standard Deviation|Mean
2636898|NCT01786876|Primary|Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||percentage of radioactivity||Standard Deviation|Mean
2636899|NCT01786876|Primary|Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||percentage of radioactivity||Standard Deviation|Mean
2636965|NCT01786187|Primary|Determine Feasibility as Measured by Rates of Recruitment.|Rates of recruitment were measured by the percentage of those eligible who enrolled.|At the beginning of the study.|The overall number of participants analyzed, is the number of eligible participants after screening.|||percentage of participants|||Number
2636900|NCT01786876|Primary|Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||hours||Standard Deviation|Mean
2636901|NCT01786876|Primary|Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||hours||Full Range|Median
2636902|NCT01786876|Primary|Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||pg equivalents/ml||Standard Deviation|Mean
2636903|NCT01786876|Primary|AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||pg equivalents*h/ml||Standard Deviation|Mean
2636904|NCT01786876|Primary|Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||hours||Standard Deviation|Mean
2636905|NCT01786876|Primary|Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||hours||Full Range|Median
2636906|NCT01786876|Primary|Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||pg equivalents/ml||Standard Deviation|Mean
2636907|NCT01786876|Primary|AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||pg equivalents*h/ml||Standard Deviation|Mean
2636908|NCT01786876|Primary|Plasma Half-Life (T1/2) of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||hours||Standard Deviation|Mean
2636909|NCT01786876|Primary|Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-002358||Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||hours||Full Range|Median
2636910|NCT01786876|Primary|Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-002358|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.|Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||pg/ml||Standard Deviation|Mean
2636911|NCT01786876|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358|Area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 240 hours post-dose|Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results.|||pg*h/ml||Standard Deviation|Mean
2636912|NCT01786707|Secondary|The Number of Subjects With a Reduction of >1% in HbA1c||at 1 year||||Participants|||Count of Participants
2636913|NCT01786707|Primary|Number of Participants With a Reduction of HbA1c of >0.5%||1 year||||Participants|||Count of Participants
2636923|NCT01786668|Secondary|Percentage of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 Response at Weeks 2, 4, 8 and 12|BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. The final BASDAI score range from 0-10. A positive response was defined as a 50% improvement in the BASDAI from baseline.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit|||Percentage of participants|||Number
2636914|NCT01786668|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Weeks 2, 4, 8 and 12|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Units on a scale||Standard Error|Least Squares Mean
2636915|NCT01786668|Secondary|Change From Baseline in EuroQol EQ-5D Health State Profile (EQ-5D) Utility Score at Week 12|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state [no problems], 3=worst health state [confined to bed]).|Baseline, Week 12|FAS|||Units on a scale||Standard Error|Least Squares Mean
2636916|NCT01786668|Secondary|Change From Baseline to Week 12 in Short-Form-36 Health Survey (SF-36) Physical and Mental Health Scores at Week 12|SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (0=no functioning, 100=highest level of functioning). Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 12|FAS|||Units on a scale||Standard Error|Least Squares Mean
2636917|NCT01786668|Secondary|Change From Baseline of Mean Spinal Mobility (Chest Expansion) at Week 2, 4, 8 and 12|Chest expansion, measured in centimeters (cm), is defined as the difference in the thoracic circumference during full expiration versus full inspiration. This was measured at the 4th intercostal space. The difference between maximal inspiration and expiration of the two attempts was recorded. The better of the two attempts was used to calculate chest expansion. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||cm||Standard Error|Least Squares Mean
2636918|NCT01786668|Secondary|Change From Baseline of Total Swollen Joint Count at Weeks 2, 4 8 and 12|This assessment was performed by the blinded assessor using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints) for determination of the total number of swollen joints. Forty-four joints were assessed for swelling on left and right side and included the following: sternoclaviculars, acromioclaviculars, shoulders, elbows, wrists, metacarpophalangeals (I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (II, III, IV, V), knees, ankles, and metatarsophalangeals (I, II, III, IV, V). Artificial joints were not assessed. A negative change means improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Swollen Joints||Standard Error|Least Squares Mean
2636919|NCT01786668|Secondary|Extra-Articular Involvement From Specific Ankylosing Spondylitis Medical History|Participants were assessed at Baseline, Week 12 and Week 16 (Follow-up) to determine if they had specific Ankylosing Spondylitis medical history or changes in specific Ankylosing Spondylitis medical history which included: Inflammatory Bowel Disease (IBD), Peripheral Articular Involvement (PAI; as assessed by swollen joint count), psoriasis (PSO) and uveitis (UVE).|Baseline, Week 12 and Follow-up|FAS - n=number of participants completing the Specific Medical History Assessment at each visit.|||Percentage of Participants|||Number
2636920|NCT01786668|Secondary|Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Weeks 4, 8 and 12|Assessment of enthesitis of 13 sites was performed in the following, 1st costochondral joint left and right, 7th costochondral joint left and right, posterior superior iliac spine left and right, anterior superior iliac spine left and right, iliac crest left and right, 5th lumbar spinous process and proximal insertion of Achilles tendon left and right. Each site was graded for the presence (1) and absence (0) of tenderness yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness).|Baseline, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Units on a scale||Standard Error|Least Squares Mean
2636921|NCT01786668|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 2, 4, 8 and 12|BASMI is an objective measure of spinal mobility and was completed by a blinded assessor. The BASMI score is composed of 5 clinical measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. The derived score used the average of the 5 assessments on a scale of 0-10 scale with higher scores indicating more impairment of spinal mobility. BASMI was analyzed using the linear function method. The higher the negative value the better the improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Units on a scale||Standard Error|Least Squares Mean
2636922|NCT01786668|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 2, 4, 8 and 12|BASFI is a validated self-assessment tool that determines the degree of physical functional limitation in Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0=easy, 10=impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions with lower scores indicating better physical function. The higher the negative value the better the improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Units on a scale||Standard Error|Least Squares Mean
2637029|NCT01785615|Secondary|Mean Diastolic Blood Pressure|Measured with a blood pressure cuff|0 weeks||||mm Hg||Standard Deviation|Mean
2637030|NCT01785615|Secondary|Mean Systolic Blood Pressure|Measured with a blood pressure cuff|0 weeks||||mm Hg||Standard Deviation|Mean
2636924|NCT01786668|Secondary|Change From Baseline in BASDAI Total Score at Week 2, 4, 8 and 12|BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis. Utilizing a Numerical Rating Scale (NRS) of 0-10 (0 = none and 10 = very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q)1-4. This score is then divided by 5. BASDAI=Q1+Q2+Q3+Q4+[Q5+Q6/2]/5. The final BASDAI score averages the individual assessments for a final score range of 0-10. Negative values indicate improvement.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Units on a scale||Standard Error|Least Squares Mean
2636925|NCT01786668|Secondary|Percentage of Participants Achieving ASDAS Inactive Disease at Weeks 2, 4, 8 and 12|The ASDAS inactive disease was calculated from the ASDAS data. The ASDAS inactive disease was defined as ASDAS <1.3 units. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit|||Percentage of participants|||Number
2636926|NCT01786668|Secondary|Percentage of Participants With ASDAS Major Improvement at Weeks 2, 4, 8 and 12|The ASDAS major improvement was calculated from the ASDAS data. The ASDAS major improvement was defined as change (decrease) from baseline of ≥2.0 units. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit|||Percentage of participants|||Number
2636927|NCT01786668|Secondary|Percentage of Participants With ASDAS Clinically Important Improvement at Weeks 2, 4, 8 and 12|The ASDAS clinically important improvement was calculated from the ASDAS data. The ASDAS clinically important improvement is defined as change (decrease) from baseline of ≥1.1 units. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit|||Percentage of participants|||Number
2636928|NCT01786668|Secondary|Change From Baseline of Ankylosing Spondylitis Disease Activity Score Using C-Reactive Protein ASDAS(CRP) at Weeks 2, 4, 8 and 12|The ASDAS(CRP) is a derived score that uses back pain, duration of morning stiffness, Patient's Global Assessment of their disease and peripheral pain/swelling. The formula used for calculating the ASDAS (CRP)is: 0.12 x Back Pain + 0.06 x Duration of Morning Stiffness + 0.11 x Patient Global + 0.07 x Peripheral Pain/Swelling + 0.58 x Ln(CRP+1). The calculated score can be from 0 to no defined upper limit. A negative number indicates a reduction in the score which indicates decrease in disease activity.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Units on a scale||Standard Error|Least Squares Mean
2636929|NCT01786668|Secondary|Percentage of Participants Achieving ASAS5/6 Response at Weeks 2, 4, 8 and 12|ASAS5/6 consists of 6 domains: the 4 used in ASAS20 (Patient's Global Assessment of Disease Activity, spinal pain, function, inflammation plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). ASAS 5/6 is defined as ≥20% improvement in at least 5 domains and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit|||Percentage of participants|||Number
2636930|NCT01786668|Secondary|Percentage of Participants Achieving 40% Improvement in ASAS Score at Weeks 2, 4, 8 and 12|ASAS 40 is defined as ≥40% and absolute change of ≥2 units in at least 3 domains on a 0-10 scale (0=no disease activity, 10=high disease activity), and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.|Baseline, Week 2, Week 4, Week 8, Week 12|FAS - n=number of responders at each visit.|||Percentage of participants|||Number
2636931|NCT01786668|Secondary|Change From Baseline in Modified Berlin Ankylosing Spondylitis Spine Magnetic Resonance Imaging Activity Score (ASspiMRI) of the Spine at Week 12|Berlin modification of the ASspiMRI is a measure of acute lesion as determined by short-tau inversion recovery (STIR) sequences. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1), defined as the region between 2 virtual lines through the middle of each vertebra, were scored in a single dimension, which is represented the highest level of inflammation in that particular DVU. Total spine ASspiMRI scores can range from 0-69 with higher scores indicating more disease activity. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Units on a scale||Standard Error|Least Squares Mean
2636932|NCT01786668|Secondary|Change From Baseline in SPARCC MRI Index of Disease Activity Score of the Spine at Week 12|SPARCC scoring of the magnetic resonance imaging (MRI) of the spine consists of assessing six disco-vertebral units (DVU) with 3 consecutive sagittal slices at each DVU. The minimum and maximum SPARCC score for all 6 DVUs is 0 to 108, with higher scores indicating more damage. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Units on a scale||Standard Error|Least Squares Mean
2636933|NCT01786668|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score of the Sacroiliac (SI) Joints at Week 12|SPARCC scoring consists of assessing six SI joint MRI image coronal slices representing the largest proportion of the synovial compartment of the SI joints for edema. The maximum score per slice was 2 and 12 for all 6 slices. The total minimum and maximum score for all SI joints across 6 slices is 0 to 72 and higher scores indicate more inflammation. A negative change from baseline indicates improvement. Missing data at Week 12 were imputed by LOCF if data at an early visit (discontinuation visit) were available.|Baseline, Week 12|FAS - when change from baseline is analyzed, FAS requires that participants have a baseline and at least one post-baseline measurement|||Units on a scale||Standard Error|Least Squares Mean
2636947|NCT01786551|Primary|Vascular and Systemic Inflammation as Measured by Interleukin-6 (IL-6) Serum Levels|At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.|Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment|Data reported for evaluable participants only. All participants who completed the study and had glucose data available.|||ng/mL||Standard Deviation|Mean
2636934|NCT01786668|Secondary|Percentage of Participants Achieving 20% Improvement in ASAS Score at Weeks 2, 4 and 8|Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.|Baseline, Week 2, Week 4, Week 8|FAS - n=number of responders at each visit.|||Percentage of participants|||Number
2636935|NCT01786668|Primary|Percentage of Participants Achieving ASAS20 at Week 12|The supportive analysis of this outcome measure was performed using the normal approximation for two proportions. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.|Baseline, Week 12|FAS|||Percentage of participants|||Number
2636936|NCT01786668|Primary|Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12|The primary analysis of this outcome measure was performed using the Emax model. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.|Week 12|Full Analysis Set (FAS): included all participants who were randomized to the study and received at least one dose of the randomized study drug (Tofacitinib or placebo).|||Percentage of participants|||Number
2636937|NCT01786629|Primary|"Percentage of Subjects With a Successful Preparation (Cleaning Rated as Good or Excellent)"||Day of colonoscopy|The analysis population contains subjects that consumed any portion of their bowel preparation. Subject who discontinued from the study for reasons other safety of efficacy are not included (e.g. insurance issues).|||percentage of subjects|||Number
2636938|NCT01786603|Secondary|Effect of Study Drug on Oxidative Stress|Determine if oxygen radical antioxidant capacity is targeted by rasagiline in participants with ALS. Assessed at baseline, month 6, and month 12; change from baseline to month 12 reported. Extra time point was not a pre-specified Primary or Secondary Outcome Measure.|Oxidative Stress change from Baseline to Month 12||||pmole/ml||Standard Deviation|Mean
2636939|NCT01786603|Secondary|Effect of Study Drug on Apoptosis Markers|Effect of rasagiline on the apoptosis markers (Annexin V stain) in participants with ALS. Assessed at baseline, month 6, and month 12; change from baseline to month 12 reported. Extra time point was not a pre-specified Primary or Secondary Outcome Measure.|Apoptosis Marker change from Baseline to Month 12||||percentage of change||Standard Deviation|Mean
2636940|NCT01786603|Secondary|Difference in Survival Status Between Study Groups|Determine if there is a difference in survival between participants on rasagiline than patients not on rasagiline|Survival status at Month 12||||Participants|||Count of Participants
2636941|NCT01786603|Secondary|Number of Participants With Adverse Events|Determine if participants on rasagiline 2 mg had a different safety profile than patients not on rasagiline. Adverse event information to be collected from date of enrollment until end of study participation.|Adverse Events from Baseline to Month 12||||Participants|||Count of Participants
2636942|NCT01786603|Secondary|Change in Quality of Life|Participants completed the single-item ALSQOL (ALS Quality of Life) which asks participants to rank their global quality of life, considering all parts of their lives - physical, emotional, social, spiritual and financial - in the last 7 days and rate on a scale of 0 (very bad) to 10 (excellent).|Quality of Life Change from Baseline to Month 12||||Score on a scale||95% Confidence Interval|Mean
2636943|NCT01786603|Secondary|Change in Vital Capacity (VC)|Determine if decline in vital capacity is slower in participants taking 2 mg rasagiline than controls.|Vital Capacity Change from Baseline to Month 12||||Liters||95% Confidence Interval|Mean
2636944|NCT01786603|Primary|ALS Functional Rating Scale-Revised (ALSFRS-R)|Difference in ALS Functional Rating Scale - Revised (ALSFRS-R) score. The ALSFRS-R is an ordinal rating scale that assesses 12 functional activities. Each activity is scored between 0-4, with a total score ranging from 48 (normal function) to 0 (no function).|ALS Functional Rating Scale-Revised (ALSFRS-R) Difference from Baseline to Month 12||||score on a scale||95% Confidence Interval|Mean
2636945|NCT01786551|Secondary|Post-prandial Insulin Serum Levels|At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.|Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment|Data reported for evaluable participants only. All participants who completed the study and had glucose data available.|||uU/ml||Standard Deviation|Mean
2636946|NCT01786551|Secondary|Post-prandial Glucose Serum Levels|At Visit 1, blood was drawn before and then 2h and 4h after a high-fat/high-glucose meal (50 g fat, 75 g glucose). Participants then followed a low-dose eplerenone treatment (50 mg daily) for 14 days. At Visit 2, blood was drawn again before, 2h, and 4h after a high-fat/high-glucose meal after 14 days.|Baseline, 2 hours, and 4 hours, measured before and after 2 weeks of eplerenone treatment|Data reported for evaluable participants only. All participants who completed the study and had glucose data available.|||mg/dl||Standard Deviation|Mean
2641624|NCT01744392|Secondary|Blood Pressure at Baseline|Clinical Characteristics at Baseline for Systolic & Diastolic Blood Pressure,|baseline||||mmHg||Standard Deviation|Mean
2636948|NCT01786343|Secondary|Response Duration|The date of response to date of loss of response or last follow-up. Response is defined as Complete Response (CR) + Partial Remission (PR) + Complete Remission with incomplete recovery (CRi) + Clinical Benefit. CR is the normalization of the peripheral blood and bone marrow with </= 5% bone marrow blasts, a peripheral blood granulocyte count >/= (1.0 x 10^9/L, and a platelet count >/= 100 x 10^9/L). PR is the same as CR except for the presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment. CRi meets all criteria for CR except for platelet recovery to >100 x 10^9/L and/or granulocyte count > (1.0 x 10^9/L). Clinical benefit is platelets increase by 50% and to above 30 x 10^9/L untransfused (if lower than that pretherapy); or granulocytes increase by 100% and to above 10^9/L (if lower than that pre-therapy); or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by > 50%; or monocytosis reduction by > 50% if pretreatment|Up to 5 years||||Months||Full Range|Median
2636949|NCT01786343|Secondary|Overall Survival|Time from date of treatment start until date of death due to any cause or last Follow-up.|Up to 5 years||||Months||Full Range|Median
2636950|NCT01786343|Primary|Participants With a Response|Response is defined as Complete Response (CR) + Partial Remission (PR) + Complete Remission with incomplete recovery (CRi) + Clinical Benefit. CR is the normalization of the peripheral blood and bone marrow with </= 5% bone marrow blasts, a peripheral blood granulocyte count >/= (1.0 x 10^9/L, and a platelet count >/= 100 x 10^9/L). PR is the same as CR except for the presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment. CRi meets all criteria for CR except for platelet recovery to >100 x 10^9/L and/or granulocyte count > (1.0 x 10^9/L). Clinical benefit is platelets increase by 50% and to above 30 x 10^9/L untransfused (if lower than that pretherapy); or granulocytes increase by 100% and to above 10^9/L (if lower than that pre-therapy); or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by > 50%; or monocytosis reduction by > 50% if pretreatment > 5 x 109/L.|Up to 3 months||||Participants|||Count of Participants
2636951|NCT01786330|Primary|Worst Pain Level Postoperative|"SF-MPQ2 Pain assessment scale was used to measure worst pain level postoperative. The pain assessment was self-administered. Worst pain was reported using a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as you can imagine. Worst pain level is reported as means for each participant group."|24 hours postoperative||||units on a scale||Standard Deviation|Mean
2636952|NCT01786330|Primary|Average Pain Level Postoperative|"SF-MPQ2 Pain assessment scale was used to measure average pain level postoperative. The pain assessment was self-administered. Average pain was reported using a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as you can imagine. Reported average pain level is reported as means for each participant group."|24 hours postoperative||||units on a scale||Standard Deviation|Mean
2636953|NCT01786330|Primary|Lowest Pain Level Postoperative|"SF-MPQ2 Pain assessment scale was used to measure lowest pain level postoperative. The pain assessment was self-administered. Lowest pain was reported using a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as you can imagine. Lowest pain level is reported as means for each participant group."|24 hours postoperative||||units on a scale||Standard Deviation|Mean
2636954|NCT01786330|Secondary|Change in Hemoglobin Concentration|Hemoglobin concentration will be assessed 24 hours after surgery by assessing routine post-operative lab values. Outcome is reported as average difference between pre-operative hemoglobin concentration and post-operative hemoglobin concentration. The negative number indicates the drop in hemoglobin concentration postoperatively.|24 hours from baseline||||g/dL||Standard Deviation|Mean
2636955|NCT01786252|Primary|Expression of hCG Target C3 Protein by IHC in Endometrial Stroma|Staining intensity of each section was quantified by image analysis software ImageJ (NIH) resulting in a Digital Histology Score (D-HSCORE), ranging from 0 to 255. Higher scores are associated with stronger staining/expression, while lower scores are the opposite.|2 days following infusion of hCG or IVF media||||D-HSCORE||Standard Deviation|Mean
2636956|NCT01786252|Primary|Expression of hCG Target NOTCH1 Protein by IHC in Endometrial Stroma|Staining intensity of each section was quantified by image analysis software ImageJ (NIH) resulting in a Digital Histology Score (D-HSCORE), ranging from 0 to 255. Higher scores are associated with stronger staining/expression, while lower scores are the opposite.|2 days following infusion of hCG or IVF media||||D-HSCORE||Standard Deviation|Mean
2636957|NCT01786252|Primary|Expression of hCG Target NOTCH1 Protein by IHC in Endometrial Glands|Staining intensity of each section was quantified by image analysis software ImageJ (NIH) resulting in a Digital Histology Score (D-HSCORE), ranging from 0 to 255. Higher scores are associated with stronger staining/expression, while lower scores are the opposite.|2 days following infusion of hCG or IVF media||||D-HSCORE||Standard Deviation|Mean
2636958|NCT01786252|Primary|Endometrial Staging in hCG Versus Vehicle Treated Patients|All H&E-stained endometrial biopsies were analyzed in a blinded manner for endometrial dating and glandular and stromal development. Criteria for endometrial dating included the presence or absence of sub-nuclear vacuoles, which is one of the more reproducible features of the Noyes dating criteria. For the purposes of statistical analysis, the most advanced elements in each of the two endometrial compartments were considered. Data are specifically reported as days post-ovulation induction.|2 days following infusion of hCG or IVF media||||days||Standard Error|Mean
2636959|NCT01786239|Primary|Treatment Response|The primary outcome measure will be the total Brief Psychiatric Rating Scale Score. The range of the BPRS is 0 to 126 with higher scores indicated more psychological symptoms.|16 weeks||||units on a scale||Standard Error|Least Squares Mean
2636960|NCT01786187|Secondary|Cancer-Related Fatigue Severity|The range of the score was 0 to 10 with 10 meaning the worst cancer-related fatigue and zero meaning no cancer-related fatigue.|At six weeks after discharge from the hospital after surgery for lung cancer.||||units on a scale||Standard Deviation|Mean
2636961|NCT01786187|Primary|Feasibility as Measured by Adverse Events.|Adverse Events is the percentage of participant's who had an adverse event.|6-weeks.||||percentage of participants|||Number
2636962|NCT01786187|Primary|Feasibility as Measured by Adverse Events.|Adverse Events is the percentage of participant's who had an adverse event.|6-weeks.|||||||
2636963|NCT01786187|Primary|Feasibility as Measured by Retention.|Retention is the percentage of those enrolled and completed and finished the program.|6-weeks.|Only measured in the Light Physical Activity Group.|||percentage of participants|||Number
2636964|NCT01786187|Primary|Feasibility as Measured by Adherence.|Adherence is the percentage of those adhering to the recommended exercise.|6-weeks.|Only measured in the light physical activity group.|||percentage of participants|||Number
2636966|NCT01786174|Secondary|Forced Expiratory Volume in 1 Second (FEV1) / Slow Vital Capacity (SVC) Ratio|"Forced Expiratory Volume (FEV1): Forced Expiratory Volume (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.~Slow Vital Capacity (SVC): Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as a percent of predicted normal."|Screening, Week 0, Week 2, and Week 4|The reported results are model estimates from a model that estimates a single baseline value across all randomized participants, i.e., reflecting the true state of the population prior to randomization.|||Percentage of predicted max value||95% Confidence Interval|Mean
2636967|NCT01786174|Primary|Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume (FEV1): Forced Expiratory Volume (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Screening, Week 0, Week 2, and Week 4|The reported results are model estimates from a model that estimates a single baseline value across all randomized participants, i.e., reflecting the true state of the population prior to randomization.|||Percentage of predicted max value||95% Confidence Interval|Mean
2636968|NCT01786174|Primary|Change in Slow Vital Capacity Score (SVC)|The vital capacity (VC) (percent of predicted normal) was determined using the slow VC method. Vital Capacity is the maximum amount of air a person can expel from the lungs after a maximum inhalation. A subject's VC depends on their age, sex and height. The value is recorded as a percent of predicted normal.|Week 0, Week 2, Week 4 and Week 8||||Percentage of predicted max value||95% Confidence Interval|Mean
2636969|NCT01786174|Primary|ALSFRS-R Total Score at Weeks 0, 2, 4 and 8|The ALSFRS-R is a quickly administered (5 minutes) ordinal rating scale (ratings 0-4) used to determine subjects' assessment of their capability and independence in 12 functional activities. All 12 activities are relevant in ALS. Initial validity was established by documenting that in ALS patients, change in ALSFRS-R scores correlated with change in strength over time, was closely associated with quality of life measures, and predicted survival.|Week 0, Week 2, Week 4 and Week 8|The reported results are model estimates from a model that estimates a single baseline value across all randomized participants, i.e., reflecting the true state of the population prior to randomization.|||scores on a scale||95% Confidence Interval|Mean
2636970|NCT01786174|Secondary|Lymphocyte (T-Cell) Subset Trajectories|Gilenya (fingolimod) has been shown to successfully reduce circulating lymphocytes (a type of white blood cell) by blocking their egress (exit) from the lymph nodes. A secondary objective of the study is to quantify the effect of the treatment on circulating lymphocyte populations in patients with ALS.|Week 0, Week 2, and Week 4||||10^3/uL||95% Confidence Interval|Mean
2636971|NCT01786161|Secondary|Vancomycin Concentration at 24 Hours|The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV|24 hours||||mcg/mL||Standard Deviation|Mean
2636972|NCT01786161|Secondary|Time Required to Reach the Therapeutic Levels|The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV|as long as participants are receiving Vancomycin (mean (SD) 9 (3.8) days for continuous, 8.4 (4.1) days for intermittent)||||hours||Standard Deviation|Mean
2636973|NCT01786161|Primary|Number of Participants Who Achieved the Target Vancomycin Concentration|The therapeutic level was defined as 15-20 mcg/mL for IIV and 15-25 mcg/mL for CIV|24 hours||||Participants|||Count of Participants
2636974|NCT01786148|Secondary|Clinical Indicator: Number of Participants With Non-detectable Viral Load|"Change in number of participants with viral load presented as number of copies if <50 copies versus ≥ 50 copies. Subjects were coded as having non-detectable viral loads if the load was < 50 copies. The analyses performed reflects the number of subjects with non-detectable load (<50) at Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention."|Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention|Only number of participants with available lab tests are included in this analysis.|||Participants|||Count of Participants
2636975|NCT01786148|Secondary|Clinical Indicator: Change in Mean CD4 Percentage|CD4 count is a test that measures the number of CD4 cells in your blood. CD4 cells, also known as T cell lymphocytes, are white blood cells that fight infection and play an important role in your immune system. A CD4 count is used to check the health of the immune system in people infected with HIV (human immunodeficiency virus). The count measures the number of CD4 cells in a small sample of blood. The percent of CD4 cells measure the percentage of all lymphocytes that are CD4 cells. The study assesses the percentage of CD4 lymphocytes over time.|Baseline, 3 months post-intervention, 6 months post-intervention, 9 months post-intervention, 9 to 12 months post-intervention|Population includes participants with a valid CD4 sample analyzed.|||percentage of CD4||Standard Deviation|Mean
2636976|NCT01786148|Secondary|Change in Antiretroviral (ART) Drug Levels in Hair Sample Analyses.|No data available due to inability of the lab to accurately extract drug from hair.|3, 6, and 9 months post-baseline|Data were not collected.||||||
2636977|NCT01786148|Primary|Change in Antiretroviral Therapy (ART) Adherence Rates|Adherence rate was measured with the Antiretroviral General Adherence Scale (AGAS) which measures the general ease and ability to take one's medication as prescribed in the past 30 days. It includes 5 items scored 1 to 6, with the possible scores for this instrument ranging from 5 to 30, and higher scores reflect better adherence.|Baseline, 3 months post-baseline, 6 months post-baseline and 9 months post-baseline|Population included only subjects that were able to complete the Antiretroviral General Adherence Scale (AGAS) which measures the general ease and ability to take one's medication as prescribed in the past 30 days. The possible scores for this instrument range from 5 to 30, and higher scores reflect better adherence.|||score on a scale||Standard Deviation|Mean
2636978|NCT01786109|Secondary|Post-Treatment Sensory Threshold for First Perception of Gas|The sensory threshold for first perception of gas was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.|1 hour after drug was ingested|Intention-to-treat analysis|||mm Hg||Standard Deviation|Mean
2637061|NCT01785524|Primary|Change in Exercise Capacity - Time to Exhaustion (TTE)|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test for determination of Time to Exhaustion (TTE)|Baseline & 16 Weeks||||seconds||Standard Deviation|Mean
2636979|NCT01786109|Secondary|Post-treatment Sensory Threshold for First Sensation|The sensory threshold for first sensation was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.|1 hour after drug was ingested|Intention-to-treat analysis|||mm Hg||Standard Deviation|Mean
2636980|NCT01786109|Secondary|Postprandial Colonic Motility Index|Colonic phasic pressure activity is summarized as a motility index (MI)=log_e[number of contractions * sum of amplitudes) + 1]. A normal fasting average motility index (MI) would be about 12. An increase in MI means an increase in the phasic contractions (in contrast to tone) which is measured as a change in volume of the barostat balloon. (Therefore, an increase in MI means that the meal is moving more quickly through the colon.)|1 hour after ingestion of standard meal|Intention-to-treat analysis|||log mm Hg||Standard Deviation|Mean
2636981|NCT01786109|Secondary|Fasting Colonic Tone|Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon.)|After 12 hour fast, before drug administered|Intention-to-treat analysis|||mL||Standard Error|Mean
2636982|NCT01786109|Secondary|Post-Treatment Overall Sensory Rating in Response to 16, 24, 32, and 40 mm Hg Distensions|The sensory rating was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.|1 hour after drug was ingested|Intention-to-treat analysis|||mm||Standard Error|Mean
2636983|NCT01786109|Secondary|Post-treatment Sensory Threshold for First Perception of Pain|The sensory threshold for first perception of pain was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation.|1 hour after drug was ingested|Intention-to-treat analysis|||mm Hg||Standard Deviation|Mean
2636984|NCT01786109|Secondary|Postprandial Change in Colonic Tone|Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon.)|1 hour after ingestion of standard meal|Intention-to-treat analysis|||mL||Standard Error|Mean
2636985|NCT01786109|Primary|Colonic Compliance at Pressure at Half-Maximum Volume (Pr 1/2)|"Colonic compliance is a measure of the stiffness of the colon, that is, what pressure was needed to reach half the maximum volume of the colon.~After the barostat catheter was inserted in the colon, the catheter was connected to a barostat machine. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg up to 64 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance."|1 hour after drug was ingested|Intention-to-treat analysis|||mL/mm Hg||Standard Error|Mean
2636986|NCT01785875|Primary|Change From Baseline in Blood Pressure|Blood pressure (BP) values were taken post-hemodialysis assessments.|Baseline and Weeks 24 and 48|Participants who received at least 1 dose of etelcalcetide and with available data at each time point (indicated by n)|||mmHg||Standard Error|Mean
2636987|NCT01785875|Secondary|Percent Change From Baseline in Mean Phosphorus During the EAP12||Baseline and the efficacy assessment phase at month 12 (weeks 46-53)|Participants with available data|||percent change||Standard Error|Mean
2636988|NCT01785875|Secondary|Percent Change From Baseline in Mean Phosphorus During the EAP||Baseline and the efficacy assessment phase|Participants with available data|||percent change||Standard Error|Mean
2636989|NCT01785875|Secondary|Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12||Baseline and the efficacy assessment phase at month 12 (weeks 46-53)|Participants with available data|||percent change||Standard Error|Mean
2636990|NCT01785875|Secondary|Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP||Baseline and the efficacy assessment phase|Participants with available data|||percent change||Standard Error|Mean
2636991|NCT01785875|Secondary|Percent Change From Baseline in Mean Corrected Calcium During the EAP12||Baseline and the efficacy assessment phase at month 12 (weeks 46-53)|Participants with available data|||percent change||Standard Error|Mean
2636992|NCT01785875|Secondary|Percent Change From Baseline in Mean Corrected Calcium During the EAP||Baseline and the efficacy assessment phase|Participants with available data|||percent change||Standard Error|Mean
2636993|NCT01785875|Secondary|Percent Change From Baseline in Mean PTH During the EAP12||Baseline and the efficacy assessment phase at month 12 (weeks 46-53)|Participants with available data|||percent change||Standard Error|Mean
2636994|NCT01785875|Secondary|Percent Change From Baseline in Mean PTH During the EAP||Baseline and the efficacy assessment phase|Participants with available data|||percent change||Standard Error|Mean
2636995|NCT01785875|Secondary|Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12||Week 46 to 53|Participants with predialysis PTH assessment during the EAP12|||percentage of participants||95% Confidence Interval|Number
2636996|NCT01785875|Secondary|Percentage of Participants With PTH ≤ 300 pg/mL During the EAP||Baseline and the efficacy assessment phase|Participants with predialysis PTH assessment during the EAP who completed a minimum of 8 weeks of treatment with etelcalcetide|||percentage of participants||95% Confidence Interval|Number
2636997|NCT01785875|Secondary|Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12|The efficacy assessment phase at 12 months (EAP12) was defined as the period from week 46 to 53 (inclusive). If multiple assessments were available during the EAP12, values were averaged.|Baseline and the efficacy assessment phase at month 12 (weeks 46-53)|Participants with pre-dialysis PTH assessment at baseline and during EAP12|||percentage of participants||95% Confidence Interval|Number
2637062|NCT01785524|Primary|Change in Exercise Capacity - Maximal Oxygen Capacity (VO2peak)|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption|Baseline & 16 Weeks||||ml/kg/min||Standard Deviation|Mean
2636998|NCT01785875|Secondary|Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase|The efficacy assessment phase (EAP) is defined as the last 6 weeks before ending treatment, which was only for participants who completed a minimum of 8 weeks of treatment with etelcalcetide. If multiple assessments were available during the EAP, values were averaged.|Baseline and the efficacy assessment phase, defined as the last 6 weeks prior to ending treatment for participants who completed a minimum of 8 weeks of treatment (weeks 46-52 for participants who completed 52 weeks of treatment)|Participants with pre-dialysis PTH assessment at baseline and during the EAP who completed a minimum of 8 weeks of treatment with etelcalcetide.|||percentage of participants||95% Confidence Interval|Number
2636999|NCT01785875|Primary|Number of Participants Who Developed Anti-etelcalcetide Antibodies|A validated dual flow-cell biosensor immunoassay was used to detect antibodies capable of binding etelcalcetide. The number of participants with a negative or no result at baseline and positive binding antibodies at any time post-baseline is reported.|Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit|Participants who received at least 1 dose of etelcalcetide and with a post-baseline antibody result.|||participants|||Number
2637000|NCT01785875|Primary|Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4|Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 0 represents values in the normal range and grade 4 represents values with life-threatening consequences and urgent intervention indicated.|52 weeks|All participants who received at least 1 dose of etelcalcetide.|||participants|||Number
2637001|NCT01785875|Primary|Number of Participants With Adverse Events (AEs)|Treatment-related adverse events are those the investigator indicated as having a reasonable possibility of having been caused by etelcalcetide. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event.|From first dose until 30 days after last dose; the treatment period was 52 weeks.|All participants who received at least 1 dose of etelcalcetide.|||participants|||Number
2637002|NCT01785849|Secondary|Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set participants with observed data|||percent change||Standard Deviation|Mean
2637003|NCT01785849|Secondary|Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set participants with observed data|||percent change||Standard Error|Mean
2637004|NCT01785849|Secondary|Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase||Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set participants with observed data|||percent change||Standard Error|Mean
2637005|NCT01785849|Secondary|Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase||Baseline and the Efficacy Assessment Phase (Week 20 to Week 27)|Full analysis set participants with observed data|||percent change||Standard Error|Mean
2637006|NCT01785849|Secondary|Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase|Participants who had no scheduled assessments during the EAP were considered non-responders.|Baseline and the efficacy assessment phase (Week 20 to Week 27)|Full analysis set|||percentage of participants|||Number
2637007|NCT01785849|Primary|Percentage of Participants With a > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase|Participants who did not have any scheduled assessments during the EAP were considered non-responders.|Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).|The full analysis set, consisting of all randomized participants|||percentage of participants|||Number
2637008|NCT01785680|Secondary|Change in Recovery Status After 12 Weeks|Any changes in recovery will be measured 6 months at follow-up visit. Number of children still well nourished.|6 months||||Participants|||Count of Participants
2637009|NCT01785680|Secondary|Duration of Treatment|Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Time to achieve MUAC of 12.5 cm will be documented.|12 weeks||||Number of clinic visits||Standard Deviation|Mean
2637010|NCT01785680|Secondary|Change in Growth Rates|Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed. Measurement is taken at each visit but final recovery measurement will be used.|12 weeks||||cm||Standard Deviation|Mean
2637011|NCT01785680|Primary|Recovery Under the Integrated Program and the Standard Protocol|"Recovery by the end of treatment standard protocol will be compared to the integrated protocol. Recovery will be defined as mid upper arm circumference (MUAC) reaching ≥12.5 cm.~Subjects will return to clinic every 2 weeks until MUAC of 12.5 cm is reached or until 12 weeks has elapsed."|12 weeks|Recovery was defined as mid upper arm circumference ≥12.5 cm.|||Participants|||Count of Participants
2637012|NCT01785628|Other Pre-specified|Change in Brain Imaging by [99mTc]TRODAT-1 From Baseline to 8 Weeks.|[99mTc]TRODAT-1 : 7 patients for treatment and placebo groups, respectively.|baseline to 8 weeks|||||||
2637013|NCT01785628|Other Pre-specified|Change in Brain Imaging by 18F-FDG PET From Baseline to 8 Weeks.|18F-FDG PET scan : 8 patients for treatment and placebo groups,respectively.|baseline to 8 weeks|||||||
2637014|NCT01785628|Secondary|Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) From Baseline to 8 Weeks.|The PDQ-39 contains 39-items covering 8 discrete dimensions: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort. Each question is scored on a 5-point scale and recoded to 0 to 4 for the analysis. The total score can range from 0 to 132 and with a higher score indicating more severe symptoms.|baseline to 8 weeks|ITT Population|||Scores on a scale||Standard Deviation|Mean
2637015|NCT01785628|Secondary|Change in Beck Depression Inventory-II (BDI-II) From Baseline to 8 Weeks.|The BDI-II is a 21-item self-report questionnaire assessing the current severity of depression symptoms. Each item is scored on a scale of 0 to 3 and the total score ranges from 0 to 63. With a higher score indicating more severe symptoms.|baseline to 8 weeks|ITT Population|||Scores on a scale||Standard Deviation|Mean
2637094|NCT01785134|Secondary|Blood Pressure at 2 Years||2 years postoperative||||mm Hg systolic||Standard Deviation|Mean
2637016|NCT01785628|Secondary|Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 8 Weeks.|The HAM-D is a 21-item rating scaled which includes an emphasis on behavioral symptoms and somatic complaints that neglects self-reported feelings of distress; and an intermingling of frequency and intensity of symptoms. The total score ranges from 0 to 64: ten items are ranked on a scale from 0 to 4; 9 items are ranked 0 to 2; and 2 items are ranked 0 to 3. With a higher score indicating more severe symptoms.|baseline to 8 weeks||||Scores on a scale||Standard Deviation|Mean
2637017|NCT01785628|Secondary|Change in Behavioral Pathology in Alzheimer's Disease Rating Scale (Behave-AD) From Baseline to 8 Weeks.|The Behave-AD includes the assessment of symptoms and a global rating of caregiver distress. A total of 25 symptoms in 7 clusters are rated: paranoid and delusional ideation, hallucinations, aggressiveness, activity disturbances, diurnal rhythm disturbances, affective disturbances and anxieties, and phobias. Caregivers rate behavioral symptoms over the preceding 2 weeks on a 0 to 3 scale. The caregiver also determines a global assessment of caregiver distress on a scale of 0 to 3. The maximum score is 75 and with a higher score indicating more severe symptoms.|baseline to 8 weeks||||Scores on a scale||Standard Deviation|Mean
2637018|NCT01785628|Secondary|Change in Neuropsychiatry Inventory (NPI) From Baseline to 8 Weeks.|The NPI scale has 12 domains: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. The total score ranges from 0 to 144, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and with a higher score indicating more severe symptoms.|baseline to 8 weeks|ITT Population|||Scores on a scale||Standard Deviation|Mean
2637019|NCT01785628|Secondary|Change in Clinical Dementia Rating (CDR) From Baseline to 8 Weeks.|The CDR is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias: Memory, Orientation, Judgment & Problem Solving, Community Affairs, Home & Hobbies, and Personal Care. With a higher score indicating more severe symptoms.|baseline to 8 weeks|ITT Population|||Scores on a scale||Standard Deviation|Mean
2637020|NCT01785628|Secondary|Change in Cognitive Abilities Screening Instrument (CASI) From Baseline to 8 Weeks.|The Cognitive Abilities Screening Instrument (CASI) has a score range of 0 to 100 and provides quantitative assessment on attention, concentration, orientation, short-term memory, long-term memory, language abilities, visual construction, list-generating fluency, abstraction, and judgment. With a higher score indicating Symptom improvement.|baseline to 8 weeks|ITT Population|||Scores on a scale||Standard Deviation|Mean
2637021|NCT01785628|Primary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) From Baseline to 8 Weeks.|Outcome is defined as change in total Unified Parkinson's Disease Rating Scale (UPDRS) between the baseline to 8 weeks. The UPDRS score has three parts, part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Each consisting of questions answered on a 0-4 point scale. The minimum total score possible is 0 and the maximum total score possible is 176. Higher scores indicating more severe symptoms.|baseline to 8 weeks.|The Intent-to-Treat (ITT) Population comprised all randomised patients who took at least one dose of study medication or placebo and who had a valid baseline efficacy measure and at least one post-baseline efficacy measure.|||Scores on a scale||Standard Deviation|Mean
2637022|NCT01785615|Secondary|Mean Plasminogen Activator Inhibitor-1 in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||ng/ml||Standard Deviation|Mean
2637023|NCT01785615|Secondary|Mean Leptin in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||pg/ml||Standard Deviation|Mean
2637024|NCT01785615|Secondary|Mean Hs-C Reactive Protein in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||ng/ml||Standard Deviation|Mean
2637025|NCT01785615|Secondary|Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing. The ratio of Apo B to Apo A1 ratio was calculated.|0 weeks||||ratio||Standard Deviation|Mean
2637026|NCT01785615|Secondary|Mean Apolipoprotein B in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||mg/dl||Standard Deviation|Mean
2637027|NCT01785615|Secondary|Mean Apolipoprotein A-1 in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||mg/dl||Standard Deviation|Mean
2637028|NCT01785615|Secondary|Mean Vascular Adhesion Molecule in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||ng/ml||Standard Deviation|Mean
2637031|NCT01785615|Secondary|Mean Intercellular Adhesion Molecule in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||ng/ml||Standard Deviation|Mean
2637032|NCT01785615|Secondary|Mean High Density Lipoprotein Cholesterol in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||mg/dl||Standard Deviation|Mean
2637033|NCT01785615|Secondary|Mean Fasting Blood Glucose in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||mg/dl||Standard Deviation|Mean
2637034|NCT01785615|Secondary|Mean Myeloperoxidase in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||ng/ml||Standard Deviation|Mean
2637035|NCT01785615|Secondary|Mean Triglycerides in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||mg/dl||Standard Deviation|Mean
2637036|NCT01785615|Secondary|Mean Low Density Lipoprotein Cholesterol in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|0 weeks||||mg/dl||Standard Deviation|Mean
2637037|NCT01785615|Secondary|Mean Waist Circumference|Waist circumference was measured with a ruler tape.|week 0||||inches||Standard Deviation|Mean
2637038|NCT01785615|Primary|Mean Myeloperoxidase in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||ng/ml||Standard Deviation|Mean
2637039|NCT01785615|Primary|Mean Plasminogen Activator Inhibitor-1 in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||ng/ml||Standard Deviation|Mean
2637040|NCT01785615|Primary|Mean Soluble Vascular Adhesion Molecule in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||ng/ml||Standard Deviation|Mean
2637041|NCT01785615|Primary|Mean Soluble Intercellular Adhesion Molecule in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||ng/ml||Standard Deviation|Mean
2637042|NCT01785615|Primary|Mean Leptin in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||pg/ml||Standard Deviation|Mean
2637043|NCT01785615|Primary|Mean Alanine Aminotransferase in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||units/L||Standard Deviation|Mean
2637044|NCT01785615|Primary|Mean Aspartate Aminotransferase in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||units/L||Standard Deviation|Mean
2637045|NCT01785615|Primary|Mean Fasting Plasma Glucose in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||mg/dl||Standard Deviation|Mean
2637095|NCT01785134|Secondary|Body Composition at Two Years||2 years postoperative||||% body fat||Standard Deviation|Mean
2637046|NCT01785615|Primary|Mean High Density Lipoprotein Cholesterol in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||mg/dl||Standard Deviation|Mean
2637047|NCT01785615|Primary|Mean Diastolic Blood Pressure|Measured with a blood pressure cuff|6 weeks||||mm Hg||Standard Deviation|Mean
2637048|NCT01785615|Primary|Mean Systolic Blood Pressure|Measured with a blood pressure cuff|6 weeks||||mm Hg||Standard Deviation|Mean
2637049|NCT01785615|Primary|Mean Waist Circumference|Waist circumference was measured with a ruler tape.|6 weeks||||inches||Standard Deviation|Mean
2637050|NCT01785615|Primary|Mean High Sensitivity C-reactive Protein in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing. The ratio of Apo B to Apo A1 ratio was calculated|6 weeks||||ng/dl||Standard Deviation|Mean
2637051|NCT01785615|Primary|Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing. The ratio of Apo B to Apo A1 ratio was calculated.|6 weeks||||ratio||Standard Deviation|Mean
2637052|NCT01785615|Primary|Mean Apolipoprotein B in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||mg/dl||Standard Deviation|Mean
2637053|NCT01785615|Primary|Mean Triglycerides in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||mg/dl||Standard Deviation|Mean
2637054|NCT01785615|Primary|Mean Low Density Lipoprotein Cholesterol in Blood|Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.|6 weeks||||mg/dl||Standard Deviation|Mean
2637055|NCT01785602|Secondary|Change From Baseline in Eczema Area and Severity Index|Investigators assessed presence and severity of erythema, induration/papulation, excoriation, and lichenification in four body areas: head/neck (H), upper limbs (UL), trunk (T), and lower limbs (LL). Investigators assigned a severity score from 0 - 3 for each area (none=0, mild=1, moderate=2, and severe=3). Investigators could assign half-points. Investigators also assigned an area score from 0 (no atopic dermatitis lesion in the area) to 6 (entire area is affected) for each area. The weighting factor was 0.1 for head/neck, 0.2 for upper limbs, 0.3 for trunk, and 0.4 for lower limbs. The total body score for each body region was obtained by multiplying the sum of the severity scores of the four key signs by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gave the EASI total, ranging from 0 to 72. A higher score represented greater disease severity. A negative change from baseline indicates improvement.|Baseline, 4 weeks, 8 weeks|All randomized participants|||Score on a scale||Standard Error|Mean
2637056|NCT01785602|Primary|Change From Baseline in Eczema Area and Severity Index (EASI)|Investigators assessed presence and severity of erythema, induration/papulation, excoriation, and lichenification in four body areas: head/neck (H), upper limbs (UL), trunk (T), and lower limbs (LL). Investigators assigned a severity score from 0 - 3 for each area (none=0, mild=1, moderate=2, and severe=3). Investigators could assign half-points. Investigators also assigned an area score from 0 (no atopic dermatitis lesion in the area) to 6 (entire area is affected) for each area. The weighting factor was 0.1 for head/neck, 0.2 for upper limbs, 0.3 for trunk, and 0.4 for lower limbs. The total body score for each body region was obtained by multiplying the sum of the severity scores of the four key signs by the area score, then multiplying the result by the constant weighted value assigned to that body region. The sum of these scores gave the EASI total, ranging from 0 to 72. A higher score represented greater disease severity. A negative change from baseline indicates improvement.|Baseline, 12 weeks|All randomized participants|||Score on a scale||Standard Error|Mean
2637057|NCT01785524|Secondary|Change In Vascular Function|Vascular Function will be measured as the Brachial artery flow-mediated dilation (BAFMD)|Baseline and 16 weeks|participants who completed study|||change % dilation|||Number
2637058|NCT01785524|Secondary|Change in Angiogenesis|Gastrocnemious muscle biopsy will be performed to measure the number of capillaries per fibre as a marker of change in angiogenesis between groups.|Baseline and 16 weeks|participants who underwent the gastrocnemius muscle biopsies|||ratio of capillaries to muscle fibres||Standard Deviation|Mean
2637059|NCT01785524|Secondary|Change in Functional Ability|Six-Minute Walk test. This test simple and practical assessment of functional capacity. The test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes. The test is self-paced and assesses the submaximal level of functional capacity. The subjects choose their own intensity and are allowed to stop and rest if necessary during the test.|Baseline and 16 Weeks||||feet||Standard Deviation|Mean
2637060|NCT01785524|Primary|Change in Exercise Capacity - Claudication Onset Time (COT)|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test for determination of Claudication Onset Time (COT)|Baseline & 16 Weeks||||seconds||Standard Deviation|Mean
2673270|NCT01462877|Secondary|Change in Serum Creatine Kinase|Blood tests|Baseline up to 8 weeks after intervention|Safety set|||percentage of CK change||Full Range|Median
2637063|NCT01785472|Secondary|Number of Patients With Adverse Events, Serious Adverse Events, and Death as Assessment of Safety and Tolerability|Participants were monitored for adverse events, serious adverse events and deaths throughout the study.|baseline, 8 weeks|Safety Set (SAF): All patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment they received.|||Participants|||Number
2637064|NCT01785472|Secondary|Number of Responders|Responders are patients with msSBP response (<140 mmHg or ≥20 mmHg reduction from baseline) and msDBP response (<90 mmHg or ≥10 mmHg reduction from baseline)|baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and endpoint, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments|||Participants|||Number
2637065|NCT01785472|Secondary|Change From Baseline in Ambulatory Pulse Pressure|Ambulatory pulse pressure (PP) is calculated by hourly ambulatory SBP and hourly ambulatory DBP over a 24-hour period.|baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and endpoint, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.|||mmHg||Standard Error|Least Squares Mean
2637066|NCT01785472|Secondary|Number of Patients Achieving Successful Blood Pressure Control|Successful blood pressure control is defined as msSBP <140 mmHg and msDBP <90 mmHg.|8 weeks|Participants from the full analysis set (FAS), who had both baseline and endpoint, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.|||Number of participants|||Number
2637067|NCT01785472|Secondary|Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed|||mmHg||Standard Deviation|Mean
2637068|NCT01785472|Secondary|Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed|||mmHg||Standard Deviation|Mean
2637069|NCT01785472|Secondary|Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed|||mmHg||Standard Deviation|Mean
2637070|NCT01785472|Secondary|Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.|Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed|||mmHg||Standard Deviation|Mean
2637071|NCT01785472|Secondary|Change From Baseline in Mean 24-hour Ambulatory Blood Pressure|In this analysis, mean 24 hour ambulatory systolic blood pressure maSBP, mean 24 hour ambulatory diastolic blood pressure maDBP, daytime and nightime maSBP and maDBP will be reported. Ambulatory blood pressure monitoring over a 24 hour period will be conducted at two time points during the study.|baseline, 8 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed|||mmHg||Standard Error|Least Squares Mean
2637072|NCT01785472|Secondary|Change From Baseline in Office Pulse Pressure (msPP)|Four separate sitting BP measurements should be obtained with a full two minute interval between measurements.|baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and endpoint were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments|||mmHg||Standard Error|Least Squares Mean
2637073|NCT01785472|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg|Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement|baseline, 8 weeks|Participants from the full analysis set (FAS), who had both baseline and week 8 values, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments|||mmHg||Standard Error|Mean
2637074|NCT01785472|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg|Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements|baseline, 8 weeks|Only participants, who had both baseline and week 8 values, were included in the analysis. The FAS included all randomized participants who received study medication and had post baseline BP assessments|||mmHg||Standard Error|Least Squares Mean
2637075|NCT01785472|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg|Sitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements.|baseline, 8 weeks|Only participants, who had both baseline and week 8 values, were included in the analysis. The FAS included all randomized participants who received study medication and had post baseline BP assessments|||mmHg||Standard Error|Least Squares Mean
2637076|NCT01785459|Secondary|Symptomatic Relief of Headache|"Symptomatic relief of headache will be measured by:~Change from pre-intervention pain using a visual analog scale and ordinal scale:~Headache relief~Partial headache relief~No headache relief~Headache worsened~Treatment failure, defined as requirement for additional medication administered in the ED due to incomplete pain relief from the paraspinous bupivacaine injections or the initial dose of intravenous prochlorperazine.~Repeat visit for headache pain within 72 hour time period, excluding routine follow up care, determined by electronic medical record review and telephone follow up."|20 minutes||||Participants|||Count of Participants
2637077|NCT01785459|Primary|Incidence of Immediate and Post-discharge Complications.|Subjects will be monitored for both immediate and post discharge complications up to 72 hours after enrollment that include: persistent local pain, bleeding, infection, and inadvertent intravascular injection resulting in seizure or possible cardiovascular collapse.|72 hours|See AE results|||Participants|||Count of Participants
2637078|NCT01785459|Primary|Length of Stay|Length of stay will be calculated as total time of encounter as well as time from doctor encounter to disposition decision|enrollment day||||minutes||Standard Deviation|Mean
2637079|NCT01785186|Secondary|Changes in Baseline Laboratory Safety Parameters During Treatment and Follow-up|Frequency tables will be generated for visual acuity tests, 12 lead ECGs, clinical chemistry metrics, haematology, and urinalysis|0 - 12 weeks|||||||
2637080|NCT01785186|Secondary|Occurence of Treatment Failure (Relapse or Emergence of Drug-resistance)|Frequency of treatment failures (number of patients with relapse and/or development of drug resistance) will be recorded|0 - 12 weeks|||||||
2637081|NCT01785186|Secondary|Rate of Change in Quantitative PCR During Therapy|GeneXpert MTB/RIF (Xpert) quantitative PCR results (counts per week|0 - 12 weeks|||||||
2637082|NCT01785186|Secondary|Rate of Change in Time to Positivity|Rate of change in time to positivity in BD MGIT 960® liquid culture|0 - 12 weeks|||||||
2637083|NCT01785186|Secondary|Proportion of Negative Sputum Cultures|Proportion of patients converting to negative sputum culture (2 consecutive weekly cultures) in liquid and solid media|0 - 12 weeks|||||||
2637084|NCT01785186|Secondary|Time to First Negative Culture on Liquid and Solid Media|Time to a convert to a single negative culture on liquid and solid media|0 - 12 weeks|||||||
2637085|NCT01785186|Secondary|Pharmacodynamics Including AUC0‐24/MIC (h*ng/mL) and Cmax/MIC (ng/mL)|By combining pharmacokinetic parameters and MIC values (see below), the pharmacodynamic indices AUC0‐24/MIC (h*ng/mL) and Cmax/MIC (ng/mL) will be calculated for individual patients for experimental drugs administered. Pharmacokinetic parameters and pharmacodynamic indices will be related to efficacy and safety/tolerability endpoints.|0 - 12 weeks|||||||
2637086|NCT01785186|Secondary|Pharmacokinetics Including AUC, Cl, t1/2, Vd, and Protein Binding|"Pharmacokinetic parameters will be assessed for rifampicin, moxifloxacin and SQ109:~area under the plasma concentration curve from dosing to the end of the dosing interval (AUC 0‐24) (in h*ng/mL)~the observed maximum concentration (Cmax( (in ng/mL)~time to reach Cmax (Tmax)(in hours)~the minimum observed plasma concentration 24 hours following the last dose (Cmin) (in hours),~clearance (Cl) (in mL/minute),~volume of distribution (Vd) (in L),~elimination half‐life (T1/2,) (in hours)~free (protein‐unbound) fraction (for rifampicin only) (in percent)."|0 - 12 weeks|Pharmacokinetic population|||Rifampicin AUC(mg*h/l)||Full Range|Geometric Mean
2637087|NCT01785186|Secondary|Mycobacteriology Identification and Characterization by PCR and MIC|"Cultures grown from the screening period, and the last sputum sample with mycobacteriological growth will be assessed as follows:~Identification of M. tuberculosis complex and RIF resistance by PCR (GeneXpert MTB/RIF®),~First-line drug susceptibility testing of the M. tuberculosis isolates using the MGIT system for sensitivity to rifampicin; isoniazid, pyrazinamide, moxifloxacin or ethambutol.~Minimum inhibitory concentrations (MIC) of SQ109, rifampicin and moxifloxacin.~Typing of the infecting strain(s) by molecular methods."|0 - 12 weeks|||||||
2637088|NCT01785186|Secondary|Frequency of Adverse Events|All Adverse Events (AE), and AEs considered to be drug-related will coded using standard AE dictionaries.|0 - 12 weeks||||participants|||Number
2637089|NCT01785186|Primary|Sputum Culture Conversion (2 Negative Cultures) Using Liquid Media|From enrollment, the time to stable culture conversion (2 consecutive negative weekly cultures) in liquid media.|0 - 12 weeks|Modified intention to treat analysis|||days||Inter-Quartile Range|Median
2637090|NCT01785160|Primary|Cmax ,ss|"C max,ss (maximum measured concentration of the Raltegravir in plasma at steady state) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of Cmax,ss and their 2-sided 90% confidence intervals (CI) were calculated.~The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for 'subject' and 'treatment'.~RAL: Raltegravir , FDV: Faldaprevir"|0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132hours after RAL and FDV administration|Pharmacokinetic(PK) set:Subjects who received atleast 1 dose of study medication and who provided at least 1 observation for at least 1 PK endpoint without any important protocol violations relevant to the evaluation of relative bioavailability and did not experience emesis at or before 2 times median tmax on the pk study days of both trial periods|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2637091|NCT01785160|Primary|AUC( Tau,ss)|"AUC tau,ss (area under the concentration-time curve of the Raltegravir in plasma at steady state over the uniform dosing interval tau) Point estimates for the intrasubject ratio of the geometric means (for treatments Test and Reference) of AUC tau,ss and their 2-sided 90% confidence intervals (CI) were calculated.~The statistical model was an analysis of variance (ANOVA) on log-transformed parameters including effects for 'subject' and 'treatment'.~RAL: Raltegravir , FDV: Faldaprevir"|0.5 hours (h) before drug administration and 48 hours (h),60,72,72.5,73,73.5,74,75,76,77,78,80,82 and 84(hours) after administration of RAL alone; 96 h,108,120,120.5,121,121.5,122,123,124, 125,126,128,130 and 132 hours after RAL and FDV administration|Pharmacokinetic(PK) set:Subjects who received atleast 1 dose of study medication and who provided at least 1 observation for at least 1 PK endpoint without any important protocol violations relevant to the evaluation of relative bioavailability and did not experience emesis at or before 2 times median tmax on the pk study days of both trial periods|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2637092|NCT01785134|Secondary|Blood Lipids||2 years postoperative||||P-Cholesterol mmol/L||Standard Deviation|Mean
2637093|NCT01785134|Secondary|Body Mass Index at 2 Years||2 years postoperative||||Kg/meter squared||Standard Deviation|Mean
2637099|NCT01785095|Primary|Number of Patients Producing Anti-FSH Antibodies.|The immunogenicity potential of FSH in healthy volunteer will be assessed by analysing serum samples collected at different timepoints during two treatment cycle for oocytes donation: cycle 1, serum samples will be collected before treatment start (baseline), after 7-13 days and after 28 days of treatment; Cycle 2: serum samples will be collected before starting the second cycle (baseline 2), after 7-13 days and after 28 days of treatment. Cycle 1 and cycle 2 will be separated by a wash-out period of two months.|4 months.|presence of Antibodies against FSH|||participants|||Number
2637100|NCT01784991|Secondary|Serious Adverse Events|Defined as prolonged hypoxia, need for positive pressure ventilation or intubation, hospital admission secondary to study drug.|From administration of drug (time 0 minutes) to end of study (60 minute mark)|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2637101|NCT01784991|Secondary|Allergic Reaction to Study Drug||From administration of drug (time 0 minutes) to end of study (60 minute mark)|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2637102|NCT01784991|Secondary|Hypotension|Hypotension defined as systolic blood pressure less than 90 mmHg|Every 5 minutes from administration of drug (time 0 minutes) to end of study (60 minute mark)|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2637103|NCT01784991|Secondary|Hypoxia|Defined as SpO2 of 93% or less for 15 seconds|From administration of drug (time 0 minutes) to end of study (60 minute mark)|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2637104|NCT01784991|Secondary|Change in VAS Score|A 13 mm change or greater on a VAS score|15 min and 60 min after baseline|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2637105|NCT01784991|Secondary|Successful Treatment of Patient Pain|Defined as: Declining additional pain medication at 15 minutes or requesting additional pain medication at 15 min, but declining at 60 minutes|15 min and 60 min after baseline|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2637106|NCT01784991|Primary|Respiratory Depression|Incidence of respiratory depression (defined as a ETCO2 of 50 mmHg or greater, a 10% change from baseline, or loss of waveform for 15 seconds or greater)|From administration of drug (time 0 minutes) to end of study (60 minute mark)|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2637107|NCT01784965|Secondary|Insulin Resistance in the Liraglutide vs.Placebo Group After Calorie Restriction|Mean (+/- SD) change in insulin resistance associated with caloric restriction plus liraglutide vs. caloric restriction and placebo.|Baseline, 14 weeks||||mg/dL||Standard Deviation|Mean
2637108|NCT01784965|Secondary|Glucose-stimulated Insulin Secretion in Insulin AUC, Pmol/1x 4H|Absolute change in glucose-stimulated insulin secretion (GS-IS) associated with caloric restriction plus liraglutide vs. caloric restriction and placebo at 14 weeks|Baseline, 14 weeks||||pmol/l x4 h||95% Confidence Interval|Mean
2637109|NCT01784965|Primary|Change in Weight Reported at 14 Weeks|Change in weight with caloric restriction plus liraglutide vs. caloric restriction and placebo over 14 weeks.|Baseline and 14 weeks||||kg||95% Confidence Interval|Mean
2637110|NCT01784926|Secondary|IOL Location|Measure IOL's location with slit lamp and Pentacam.|2 years||2020-12-31|12/2020||||
2637111|NCT01784926|Secondary|Questionnaire Visual Function-14 (VF-14) Score|Questionnaire considering subjective visual function, scale 0-100 (higher scores mean better subjective visual outcome, lower scores means worse outcome).|6 months (only analyzed/reported for this time frame)|Some loss to follow-up|||score points||Standard Deviation|Mean
2637112|NCT01784926|Secondary|Keratometry|Keratometry of the cornea. Corneal astigmatism, measured in diopters.|6 months (only analyzed/reported for this time frame)|Some missing data due to poor image/measurement quality, overall number of participants therefore lower than the number of participants attending the 6-month visit|||Diopters||Standard Deviation|Mean
2637113|NCT01784926|Primary|Postoperative Complications|Cystoid macular edema considered the most important long-term complication and therefore reported here.|6 months and 2 years|Some loss to follow-up|||Participants|||Count of Participants
2637114|NCT01784926|Primary|Endothelial Density|Corneal endothelial cell density (ECD), measured by confocal microscopy. Reported in cells per square millimeter|6 months|Some missing data due to inadequate corneal images|||cells/mm^2||Standard Deviation|Mean
2637115|NCT01784926|Primary|Intraocular Pressure (IOP)|Measure for the pressure inside the eye, measured with Goldman applanation tonometer, in mmHg.|6 months and 2 years||||mmHg||Standard Deviation|Mean
2637116|NCT01784926|Primary|Best Corrected Visual Acuity (BCVA)|Measure for visual function. Measured in logMAR|6 months, 1 year and 2 years||||logMAR||Standard Deviation|Mean
2637117|NCT01784848|Secondary|Adverse Events|Describe the main adverse events|At any time during the study period|||||||
2637118|NCT01784848|Secondary|Change on Sleep Quality|Change on sleep quality as evaluated by polysomnography|12, 24, 36, 48 and 60 months|||||||
2637119|NCT01784848|Secondary|Change on Heart Anatomy|Change on heart anatomy as evaluated by echocardiogram|12, 24, 36, 48 and 60 months|||||||
2637120|NCT01784848|Secondary|Absolute Change From Baseline of Cardiovascular Risk|Absolute change from baseline of cardiovascular risk calculated by Framingham Score|12, 24, 36, 48 and 60 months|||||||
2637121|NCT01784848|Secondary|Absolute Change From Baseline on Ultra-sensitive CRP Levels|Absolute change from baseline on ultra-sensitive CRP levels|12, 24, 36, 48 and 60 months|||||||
2637122|NCT01784848|Secondary|Absolute Change From Baseline on Uric Acid Levels|Absolute change from baseline on uric acid levels|12, 24, 36, 48 and 60 months|||||||
2637123|NCT01784848|Secondary|Absolute Change From Baseline on Triglycerides Levels|Absolute change from baseline on triglycerides levels|12, 24, 36, 48 and 60 months|||||||
2637124|NCT01784848|Secondary|Absolute Change From Baseline on HDL-cholesterol Level|Absolute change from baseline on HDL-cholesterol level|12, 24, 36, 48 and 60 months|||||||
2637125|NCT01784848|Secondary|Absolute Change From Baseline on LDL-cholesterol Level|Absolute change from baseline on LDL-cholesterol level|12, 24, 36, 48 and 60 months|||||||
2637135|NCT01784848|Primary|Number of Participants With a Reduction in the Number of Anti-hypertensive Drugs Used and Maintaining Blood Pressure Below 140x90mmHg|Evaluate the efficacy of Roux-en-Y Gastric Bypass on the reduction of the number of antihypertensive drugs, maintaining a controlled blood pressure (<140x90 mmHg), in 12 months.|12 months||||Participants|||Count of Participants
2637136|NCT01784796|Secondary|Cardiovascular Risk|Cardiovascular risk as measured by Reynold's Risk Score. The Reynold's Cardiovascular Risk score predicts the percent risk of having a heart attack, stroke or other major heart disease in the next 10 years. Scores range from 0 to 100% with higher scores representing greater risk of developing cardiovascular disease in 10 years.|6 months|The number of participants who completed the Reynold's Risk Score is different than the number of participants reported in the participants flow because of missing data.|||score on a scale||Standard Deviation|Mean
2637137|NCT01784796|Primary|Quality of Life (QOL)|"Measured with Quality of Life Index-III Generic (QLI)~Total scores for the QLI range from 0 to 30 with higher scores indicating better quality of life."|8 week|Number of participants who have total scores for the QLI is different than reported in patient flow because of missing data.|||score on a scale||Standard Deviation|Mean
2637138|NCT01784796|Primary|Depressive Symptoms|"Depressive symptoms were measured with the CES-D~Total scores for the CES-D range from 0 to 60 with higher scores indicating greater depressive symptoms."|8 week|The number of participants reported for the CES-D is different than the number of participants reported in the participant flow because of missing data.|||score on a scale||Standard Deviation|Mean
2637139|NCT01784796|Primary|Perceived Stress|"Psychological stress measured with the Perceived Stress Scale (PSS).~Total scores on the PSS range from 0 to 40 with higher scores indicating higher levels of perceived stress. Scores between 0 to 13 suggest low stress, scores between 14 and 26 suggest moderate stress, and scores between 27 and 40 indicate high perceived stress."|8 week|The number of participants who completed the PSS is different than the number of participants reported in the participants flow because of missing data.|||score on a scale||Standard Deviation|Mean
2637140|NCT01784770|Secondary|Clinical Effectiveness Rate in Participants|Clinical effectiveness rate in participants, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.|29 days|"The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as unassessable were excluded from the calculation."|||Percentage of Participants||95% Confidence Interval|Number
2637141|NCT01784770|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to Zithromac Intravenous use (and Zithromac Tablets) in a participant who received Zithromac Intravenous use. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Zithromac Intravenous use (and Zithromac Tablets) was assessed by the physician.|29 days|The safety analysis set comprised of participants who satisfied the inclusion criteria and received Zithromac Intravenous use at least once.|||Participants|||Number
2637142|NCT01784666|Primary|Change in MADRS (4 Weeks)|"Change in Montgomery-Asberg Depression Rating Scale (MADRS) in isradipine-treated epochs versus placebo-treated epochs.~These scores represent total scores, and on the MADRS total scores range from 0-60. A higher score indicates increased depression severity."|Baseline vs week 4 (and, for placebo nonresponders in 1st 4 weeks, week 8 vs week 4)||||scores on a scale|||Number
2637143|NCT01784614|Secondary|PK: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of LY2624803 After Single Oral Dose in Period 4||Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4|All randomized participants who received a single oral dose of LY2624803 in Period 4 and had evaluable PK data.|||nanograms•hour/milliliter (ng•hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2637144|NCT01784614|Secondary|PK: Maximum Plasma Concentration (Cmax) of LY2624803 After Single Oral Dose in Period 4||Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4|All randomized participants who received a single oral dose of LY2624803 in Period 4 and had evaluable PK data.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2637145|NCT01784614|Secondary|Total Sleep Time (TST)|TST is defined as the total time in sleep epochs from sleep onset time to the end of the primary recording period (8 hours after lights -off). LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.|8 hours in Periods 1, 2 and 3|All randomized participants who received at least 1 dose of study drug and had PSG measurements in Periods 1, 2 and 3.|||min||90% Confidence Interval|Least Squares Mean
2637146|NCT01784614|Secondary|Latency to Persistent Sleep (LPS)|LPS is defined as the latency from the lights-off time to the first stage 2 sleep followed by at least 10 consecutive minutes of sleep epochs. Data presented are Geometric LS means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.|8 hours in Periods 1, 2 and 3|All randomized participants who received at least 1 dose of study drug and had PSG measurements in Periods 1, 2 and 3.|||min||90% Confidence Interval|Geometric Mean
2637147|NCT01784614|Primary|Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo|WASO was calculated as total time in awake epochs between sleep onset time (first stage 2 epoch) and the end of the primary recording period (8 hours after lights -off). Data presented are Geometric Least Squares (LS) means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.|8 hours in Periods 1, 2 and 3|All randomized participants who received at least 1 dose of study drug and had PSG measurements in Periods 1, 2 and 3.|||minutes (min)||90% Confidence Interval|Geometric Mean
2637577|NCT01780870|Primary|The Primary Outcome Will be HOMA-IR at Baseline and 8 Weeks|The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment|8 weeks||||HOMA score||Standard Deviation|Mean
2637148|NCT01784588|Primary|Number of Subjects Meeting Definition of Treatment Success at 36 Months, by a Composite of Objective and Subjective Measures|"An assessment of improvement in stress urinary incontinence at 36 months, by a composite of objective (negative cough stress test with protocol required bladder fill procedure) and subjective measures (subject self reported improvement in their condition, through the Patient Global Impression of Improvement (PGI-I)). The PGI-I scale rates the patient's improvement or worsening of SUI symptoms relative to baseline. The scale is as follows: 1 - Very much better; 2 - Much better; 3 - A little better; 4 - No change' 5 - A little worse; 6 - Much worse; 7 - Very much worse, with the unit of measure being scores on a scale (lower scores indicate a more positive impression of change). Subjects met the definition of treatment success at 36 months if they had an answer of No to the item Direct observation of urine loss with cough provocation and an Improvement per the PGI-I (a response of A little better, Much better, or Very much better)."|Data presented is for 36 months||||Participants|||Count of Participants
2637149|NCT01784211|Secondary|Part B: Pharmacokinetics: Cmax of LY2605541 and Insulin Glargine: Exercise Versus Non-Exercise|Venous blood samples for pharmacokinetic analysis were collected in Part B. Results were stratified by whether or not the participant was undergoing an exercise challenge (+ Exercise) at the time of sample collection.|Part B: Predose, 11 hours postdose, every 30 minutes from 16.5 to 20 hours postdose, and 24 hours postdose on Day 16 or 19|Participants in Part B who received at least 1 dose of study drug and had evaluable Cmax data.|||picomoles per liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
2637150|NCT01784211|Secondary|Part B: Pharmacokinetics: AUCτ of LY2605541 and Insulin Glargine: Exercise Versus Non-Exercise|Venous blood samples for pharmacokinetic analysis were collected in Part B. Results were stratified by whether or not the participant was undergoing an exercise challenge (+ Exercise) at the time of sample collection.|Part B: Predose, 11 hours postdose, every 30 minutes from 16.5 to 20 hours postdose, and 24 hours postdose on Day 16 or 19|Participants in Part B who received at least 1 dose of study drug and had evaluable AUCτ data.|||picomoles*hour per liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2637151|NCT01784211|Secondary|Part A: Pharmacodynamics: Total Amount of Glucose Infused Over the Duration of the Clamp (Gtot): Intra-Participant Variability|Glucodynamic measurements were collected during the euglycemic glucose clamps during Part A. The intra-participant percentage of coefficient of variation (%CV) is presented. %CV was calculated by dividing the standard deviation by the mean, multiplied by 100.|Part A: Predose up to 24 hours postdose on Days 8, 11, and 14|Participants in Part A who received at least 1 dose of study drug and had evaluable Gtot data.|||%CV||90% Confidence Interval|Number
2637152|NCT01784211|Primary|Part A: Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2605541 and Insulin Glargine: Intra-Participant Variability|Venous blood samples for pharmacokinetic analysis were collected during the euglycemic glucose clamps during Part A. The intra-participant percentage of coefficient of variation (%CV) is presented. %CV was calculated by dividing the standard deviation by the mean, multiplied by 100.|Part A: Predose and 4, 8, 12, and 24 hours postdose on Days 8, 11, and 14|Participants in Part A who received at least 1 dose of study drug and had evaluable Cmax data.|||%CV||90% Confidence Interval|Number
2637153|NCT01784211|Primary|Part A: Pharmacokinetics: Area Under the Concentration Versus Time Curve Over the Dosing Interval (AUCτ) of LY2605541 and Insulin Glargine: Intra-Participant Variability|Venous blood samples for pharmacokinetic analysis were collected during the euglycemic glucose clamps during Part A. The intra-participant percentage of coefficient of variation (%CV) is presented. %CV was calculated by dividing the standard deviation by the mean, multiplied by 100.|Part A: Predose and 4, 8, 12, and 24 hours postdose on Days 8, 11, and 14|Participants in Part A who received at least 1 dose of study drug and had evaluable AUCτ data.|||%CV||90% Confidence Interval|Number
2637154|NCT01784055|Primary|Procedure Success|To describe the rate of subjects with at least one neochord placed using the DS1000 System AND a reduction in mitral regurgitation ≤ 2+ at the time of the procedure|The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day.||||Participants|||Count of Participants
2637155|NCT01784029|Primary|Change in 25(OH)D Serum Level After Treatment for Vitamin D Deficiency (Deficiency Defined as 25(OH)D <20 ng/dL)||Baseline to 3 months||||ng/mL||Standard Deviation|Mean
2637156|NCT01783938|Secondary|Investigator-assessed Rate of Progression|The progression rate at a specific timepoint is defined as the number of participants who have Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at that specific timepoint divided by the total number of randomized participants. As specified by modified RECIST 1.1, the evaluation of PD at Week 13 and Week 25 used the baseline tumor assessment as reference. For purposes of the primary analysis of progression rates, if a treated participant were missing his/her tumor assessment at the specified study week, then the results of the previous tumor response evaluation were to be carried forward. Both clinical and radiological progressions were counted as a progression outcome. A participant who died without a reported prior progression was considered to have progressed on the date of his/her death. Deaths before or at Week 13 are counted as progression outcome. Confidence interval based on the Clopper and Pearson method.|Week 13; Week 25|All treated participants; All participants who received at least one dose of any study therapy.|||percentage of participants||95% Confidence Interval|Number
2637157|NCT01783938|Secondary|Investigator-assessed Duration of Response (DOR)|Duration of response (DOR) was performed to further characterize the response rate at Week 25. Duration of response is defined as the time between the Week 25 date of response and the date of objectively documented disease progression as defined by modified RECIST 1.1 criteria or death, whichever occurs first. DOR was assessed for participants with confirmed response at Week 25. Median computed using Kaplan-Meier product-limit method.|Week 25 up to date of disease progression or death, up to approximately 2 years|All treated participants with confirmed response at week 25; Participants were censored at their last assessment date if response was not changed.|||months||95% Confidence Interval|Median
2637169|NCT01783860|Other Pre-specified|Change of Total Severity Score Between Baseline and 31 Days Later|Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (31 days) minus earliest time point.|baseline and 31 days later||||units on a scale||Standard Deviation|Mean
2637158|NCT01783938|Secondary|Investigator-assessed Response Rate at Week 25|Response rate is defined as the number of participants who have a complete response (CR) or partial response (PR) at Week 25 per modified RECIST 1.1 criteria, with confirmation on the scheduled scan at Week 33 (or any subsequent scan performed at least 4 weeks after the Week 25 scan), divided by the total number of treated participants. Results of the tumor assessment at Week 13 or any unscheduled tumor assessment obtained prior to Week 25, except for baseline/screening tumor assessment, were not considered in the assessment of response rate at Week 25. Any treated participant without an evaluable Week 25 time point response (per modified RECIST 1.1) was considered a non-responder for primary analysis of response rate at Week 25. Evaluations occurring after the dates of subsequent anticancer therapy were not included when determining or confirming response at Week 25. Confidence interval based on the Clopper and Pearson method.|Week 25|All treated participants; All participants who received at least one dose of any study therapy.|||percentage of participants||95% Confidence Interval|Number
2637159|NCT01783938|Primary|Percentage of Participants With Treatment-related Grade 3-5 Adverse Events (AEs) During the Induction Periods|The rate or percentage of participants with treatment-related grade 3-5 AEs is defined as the number of participants who experienced at least 1 treatment related Grade 3 - 5 adverse event (AE) per NCI CTCAE version 4.0 criteria, any preferred term with an onset date after or on first day of Induction Period #1 and not later than discontinuation date from Induction Period #2, divided by the total number of treated participants. AEs with an onset date after start date of Continuation Period or start of subsequent anti-cancer therapy were not included. Adverse Event (AE)=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.|Day 1 up to Week 25|All treated participants; All participants who received at least one dose of any study therapy.|||percentage of participants||95% Confidence Interval|Number
2637160|NCT01783912|Primary|Acceptance of Wisconsin Tobacco Quit Line Services|The primary outcome is participant acceptance of evidence based treatment through the WTQL at the end of the last individual session.|4-6 weeks after study enrollment||||participants|||Number
2637161|NCT01783886|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.|Baseline up to week 52|FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2637162|NCT01783886|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.|Baseline up to week 52|FAS with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2637163|NCT01783886|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline up to week 52|FAS with assessment for this outcome measure.|||micrometer||Standard Deviation|Mean
2637164|NCT01783886|Secondary|Percentage of Participants With a Greater Than Equal (>=) Two-step Improvement From Baseline in the ETDRS Diabetic Retinopathy Severity Score (DRSS) as Assessed by Fundus Photography (FP) at Week 52 - LOCF|ETDRS DRSS: None (level 10); Mild to moderate nonproliferative diabetic retinopathy (DR) (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)|Baseline up to week 52|FAS.|||Percentage of participants|||Number
2637165|NCT01783886|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to week 52|FAS.|||Percentage of participants|||Number
2637166|NCT01783886|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to week 52|FAS.|||Percentage of participants|||Number
2637167|NCT01783886|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)|Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. LOCF censored measurements after additional treatment.|Baseline up to week 52|Full analysis set (FAS) included all randomized participants who received any study treatment, had a baseline measurement of BCVA, and had at least 1 post-baseline assessment of BCVA. FAS with assessment for this outcome measure.|||Letters correctly read||Standard Deviation|Mean
2637168|NCT01783860|Other Pre-specified|Change of Total Severity Score Between Baseline and 37 Days Later|Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (37 days) minus earliest time point.|baseline and 37 days later||||units on a scale||Standard Deviation|Mean
2637184|NCT01783743|Secondary|Specificity of TT Screening Methods|"Specificity of different TT screening methods compared to true assessment of cases and controls using the extrapolated values from the follow-up survey.~Formula used: True negatives/(true negatives +false positive)"|10 months||||percentage of true negatives||95% Confidence Interval|Number
2637170|NCT01783860|Other Pre-specified|Change of Total Severity Score Between Baseline and 7 Days Later|Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (7 days) minus earliest time point.|baseline and 7 days later||||units on a scale||Standard Deviation|Mean
2637171|NCT01783860|Primary|Change of Symptoms and Signs Scores (Difference Between Total Score of First Time and 61 Days Later), Total Severity Score|Total severity score was a combined score of symptoms and signs. For symptoms, there were five items and for signs there were seven items. Each items had three scales form Zero (no symptom) to three (severe symptom). Therefore, there was 12 items to calculate total severity score. Maximum score was 36 (worse outcome) and minimum score was zero (better outcome). A change in total severity score calculated as the latest time period (61 days) minus earliest time point.|zero time and 61 days later||||units on a scale||Standard Deviation|Mean
2637172|NCT01783860|Secondary|Main Ocular Signs|lid margin debris, lid margin redness, Meibomian gland (MG) secretion, occluded MG, conjunctival redness, tear brake up time and ocular surface staining at Baseline, and days 7, 31, 37 and 61 after treatment were measured. For each items there was a question with scale form zero to three (zero for no sign to three for maximum sign). Therefore, maximum score for signs was 21 (worse outcome) and minimum score was zero (better outcome). We calculated a total score for signs. Finally, we reported a change in total score calculated as the latest time point (61 days) minus earliest time point.|Change from baseline until 61 days after treatment||||units on a scale||Standard Deviation|Mean
2637173|NCT01783860|Primary|Change of Blepharitis Symptoms Score|Five main ocular symptoms of posterior blepharitis (itching, foreign body sensation, dryness, burning, and lid swelling) will be asked of each patient and graded at baseline, and days 7, 31, 37 and 61 after treatment. For each item there was a question with scale from zero to three (zero for no symptom three for maximum symptom). Therefore, maximum score for symptoms was 15 (worse outcome) and minimum score for symptoms was zero (better outcome). Finally, we reported a change in total score calculated as the latest time point (61 days) minus the earliest time point.|Change from the baseline until 61 days after treatment||||score||Standard Deviation|Mean
2637174|NCT01783847|Secondary|Number of Participants With Relative Afferent Papillary Defect (RAPD) Grade +4|A positive RAPD means there are differences between the two eyes in the afferent pathway due to retinal or optic nerve disease. Graded from +1 to +4. The higher one is a better grade|Change from baseline at least 3 months after treatment|Seventeen patients dropped out of the study due to incomplete follow-up (16 patients from EPO and one patient from Methylprednisolone group)|||Participants|||Count of Participants
2637175|NCT01783847|Primary|Number of Participants With Change/Improvement Visual Acuity From the Beseline|Best corrected visual acuity will measure at 1,2,3 days, 1 week, 2 weeks and 1 month and at least 3 months after treatment. Improvement is defined based on 1) mean logMAR[12], 2) 0.3 change in logMAR (improvement, deterioration, and no change) [12,16] , 3) mean improvement percentage which is calculated as: improvement%= (logMar ( of VA after treatment)-logMar ( of initial VA))/(logMar(20/13)˟-logMar ( of initial VA) 4) percentage of patients at different ordinal categorization of the BCVA as no light perception (NLP), light perception (LP)and hand motion (HM), count fingers (CF), and ≥ 20/200.|Change from baseline at least 3 months after treatment|Seventeen patients with incomplete follow up and not following the treatment protocol were also excluded during the study. There were 100 patients (100 eyes) who completed the study protocol|||Participants|||Count of Participants
2637176|NCT01783821|Secondary|Intensive Care Unit (ICU) Length of Stay||Baseline to Day 28||||days||Inter-Quartile Range|Median
2637177|NCT01783821|Secondary|Hospital Length of Stay||Baseline to Day 28||||days||Inter-Quartile Range|Median
2637178|NCT01783821|Secondary|Number of Subjects Who Developed Acute Respiratory Distress Syndrome (ARDS)|ARDS was defined per Berlin definition. Chest radiographs of all ventilated (non-invasive or invasive) patients were reviewed as consistent or not consistent with ARDS by the site investigator. A second adjudication was performed by an alternate principal investigator blinded to subject identification and clinical data. Final diagnosis of ARDS was determined centrally after chest radiograph adjudication was considered together with other relevant clinical data.|Hospital discharge, approximately day 28||||participants|||Number
2637179|NCT01783821|Secondary|Number of Subjects Who Needed Mechanical Ventilation||Hospital discharge, approximately day 28||||participants|||Number
2637180|NCT01783821|Primary|Number of Participants Experiencing Categorical Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio|The data in the table below represent the greatest change from baseline observed for any one participant over all individual post-baseline measurements.|Days 0 - 5|Intention to Treat Analysis|||participants|||Number
2637181|NCT01783821|Primary|Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio|Oxygen saturation (SpO2) was measured by pulse oximetry. FiO2 is the assumed proportion of oxygen concentration participating in gas exchange in the alveoli. All S/F measurements were performed per standard operating protocol using a Venturi mask titrated to obtain an oxygen saturation of 94 ± 2% unless the patient met this goal on room air or clinical status dictated an alternative delivery mode. This outcome measure was analyzed as a longitudinal continuous variable by a mixed effect model. The formula for the calculation of SpO2/FiO2 (or S/F ratio) is %saturation/proportion of FiO2 concentration.|baseline to day 5 after the first treatment|Intention to Treat analysis. The patient population for each day is indicated in the category by (treatment arm, placebo arm).|||SpO2/FiO2 Ratio||Inter-Quartile Range|Median
2637182|NCT01783743|Secondary|Negative Predictive Values of TT Screening Methods|"Negative Predictive Values (NPV) of the different screening methods compared to true assessment of cases and controls.~It was calculated by using extrapolated values. Formula used : True Negatives /total participants at initial screening,screened as negative by CTA's"|10 months||||percentage of true negatives||95% Confidence Interval|Number
2637183|NCT01783743|Secondary|Positive Predictive Values of TT Screening Methods|"Positive Predictive Values (PPV) of the different screening methods compared to true assessment of cases and controls.~It was calculated by using extrapolated values. The formula used: True positives /total participants at initial screening screened as positive by CTA's."|10 months||||percentage of true positives||95% Confidence Interval|Number
2637185|NCT01783743|Secondary|Sensitivity of TT Screening Methods|"Sensitivity of different TT screening methods compared to true assessment of cases and controls using the extrapolated values from the follow-up survey.~Formula used: True positives/(true positives +false negative)"|10 months||||percentage of true positives||95% Confidence Interval|Number
2637186|NCT01783743|Primary|TT Cases Screened Positive by CTA's and Confirmed by Graders|"All the TT cases detected in control versus intervention arms (adjusted for population size) through screening were verified by graders.~Grader re-graded all these cases except for the cases lost to follow-up."|10 months||||Participants|||Count of Participants
2637187|NCT01783730|Secondary|Percentage of Participants Achieving SDAI Remission|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission. The percentage of participants with an SDAI score ≤3.3 was documented.|From baseline to 24 weeks|Participants with available data|||percentage of participants|||Number
2637188|NCT01783730|Secondary|Mean Simplified Disease Activity Index (SDAI) Score at Week 24|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|at week 24|Participants with available data|||units on a scale||Standard Deviation|Mean
2637189|NCT01783730|Secondary|Mean Simplified Disease Activity Index (SDAI) Score at Week 12|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|at week 12|Participants with available data|||units on a scale||Standard Deviation|Mean
2637190|NCT01783730|Secondary|Mean Simplified Disease Activity Index (SDAI) Score at Week 4|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|at week 4|Participants with available data|||units on a scale||Standard Deviation|Mean
2637191|NCT01783730|Secondary|Mean Simplified Disease Activity Index (SDAI) Score at Baseline|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|at week 0|Participants with available data|||units on a scale||Standard Deviation|Mean
2637192|NCT01783730|Secondary|Percentage of Participants Achieving CDAI Remission|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm) , and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission. The percentage of participants with a CDAI score ≤2.8 was documented.|From baseline to 24 weeks|Participants with available data|||percentage of participants|||Number
2637193|NCT01783730|Secondary|Mean Clinical Disease Activity Index (CDAI) Score at Week 24|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.|at week 24|Participants with available data|||units on a scale||Standard Deviation|Mean
2637194|NCT01783730|Secondary|Mean Clinical Disease Activity Index (CDAI) Score at Week 12|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.|at week 12|Participants with available data|||units on a scale||Standard Deviation|Mean
2637195|NCT01783730|Secondary|Mean Clinical Disease Activity Index (CDAI) Score at Week 4|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.|at week 4|Participants with available data|||units on a scale||Standard Deviation|Mean
2637196|NCT01783730|Secondary|Mean Clinical Disease Activity Index (CDAI) Score at Baseline|The CDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.|at week 0|Participants with available data|||units on a scale||Standard Deviation|Mean
2637197|NCT01783730|Secondary|Percentage of Participants Achieving DAS28-4(ESR) Remission|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. The percentage of participants with a DAS28 score <2.6 was documented.|From baseline to 24 weeks|Participants with available data|||percentage of participants|||Number
2637198|NCT01783730|Secondary|Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 24|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|at week 24|Participants with available data|||units on a scale||Standard Deviation|Mean
2637199|NCT01783730|Secondary|Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 12|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission .|at week 12|Participants with available data|||units on a scale||Standard Deviation|Mean
2637200|NCT01783730|Secondary|Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 4|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission .|at week 4|Participants with available data|||units on a scale||Standard Deviation|Mean
2637201|NCT01783730|Secondary|Mean Disease Activity Score 28 (DAS28-4(ESR)) at Baseline|The DAS28-4(ESR) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health were included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|at week 0|Participants with available data|||units on a scale||Standard Deviation|Mean
2637202|NCT01783730|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. Adverse events were collected from the time of informed consent until the completion of the study, up to 26 weeks.|From baseline through week 26|Participants who received adalimumab treatment|||participants|||Number
2637203|NCT01783678|Secondary|Percentage of Participants Experiencing Virologic Failure|"On-treatment virologic failure was defined as either:~Virologic breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Nonresponse (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment).~Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period, having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline up to Posttreatment Week 24|Full Analysis Set. 1 participant with genotype 1 HCV infection did not have subtype information available.|||percentage of participants|||Number
2637204|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.|||log10 IU/mL||Standard Deviation|Mean
2637205|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.|||log10 IU/mL||Standard Deviation|Mean
2637206|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.|||log10 IU/mL||Standard Deviation|Mean
2637207|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.|||log10 IU/mL||Standard Deviation|Mean
2637208|NCT01783678|Secondary|HCV RNA Change From Baseline at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available.|||log10 IU/mL||Standard Deviation|Mean
2637209|NCT01783678|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set. 1 participant with genotype 1 HCV infection did not have subtype information available.|||percentage of participants|||Number
2637210|NCT01783678|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.|Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug|||percentage of participants|||Number
2637211|NCT01783678|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. 1 participant with genotype 1 HCV infection did not have subtype information available.|||percentage of participants|||Number
2637212|NCT01783639|Secondary|Procedural Success|Defined as both device and angiographic success|Participants will be followed for the duration of the procedure, an expected average of 35 minutes|||||||
2637213|NCT01783639|Secondary|Angiographic Success|Successful completion of the protected stent procedure without angiographic complications|Participants will be followed for the duration of the procedure, an expected average of 35 minutes|||||||
2637214|NCT01783639|Secondary|Neurological Events Occurring Within 30 Days Post Procedure,Including Strokes and Transient Ischemic Attacks||Within 30 Days of procedure|||||||
2637215|NCT01783639|Secondary|The Rate of Access Site Complications||Within 30 Days of procedure|||||||
2637216|NCT01783639|Secondary|The Rate of Clinical Success|Defined as freedom from procedure related serious adverse events|Participants will be followed for the duration of the procedure, an expected average of 35 minutes|||||||
2637217|NCT01783639|Secondary|The Rate of Device Success|Defined as a successful delivery, deployment and retrieval of WIRION™ without any complications|Participants will be followed for the duration of the procedure, an expected average of 35 minutes|||||||
2637218|NCT01783639|Primary|The Rate of Peri-procedural (Within 30 Days of Procedure) Death, Stroke, and Myocardial Infarction.|Each participant will be followed for 30 days of procedure during which the number of major cardiac and cerebral adverse events (Stroke, Death and Myocardial Infraction) will be counted to evaluate the device safety.|Within 30 Days of procedure||||participants||95% Confidence Interval|Number
2637219|NCT01783574|Secondary|Sexual Dysfunction|Derogatis Interview of Sexual Function (Total Score): This scale measures sexual function. Lower scores indicate worse sexual function. The score range for this questionnaire is 0-160.|Week 8||||units on a scale||Standard Error|Mean
2637220|NCT01783574|Secondary|Fatigue|Brief Fatigue Inventory: This inventory measures fatigue severity. Higher scores indicate more severe fatigue. The range is 0-10 units on a scale.|Week 8||||units on a scale||Standard Error|Mean
2637221|NCT01783574|Primary|Depressive Symptom Severity|Montgomery-Asberg Depression Rating Score (MADRS) Score: This scale measures depression symptom severity. Higher scores indicate more severe depression symptom severity. The score range is 0-60 units on a scale.|Week 8||||units on a scale||Standard Error|Mean
2637222|NCT01783561|Secondary|Systemic Blood Flow|To determine if a loading dose of intravenous caffeine administered to preterm infants (< 29 weeks) within the first 2 hours of life compared to 12 hours of life results in improved measures of systemic blood flow (measured by superior vena cava flow)|first 24 hours||||ml/kg/min||Standard Deviation|Mean
2637223|NCT01783561|Secondary|Subjects Requiring Inotropes in the First 24 Hours|To determine if a loading dose of intravenous caffeine administered to preterm infants (< 29 weeks) within the first 2 hours of life compared to 12 hours of life decreases the need for inotropes for hypotension within the first 24 hours of life.|first 24 hours of life||||Participants|||Count of Participants
2637224|NCT01783561|Primary|Intubation|The primary aim of our study is to compare the respiratory effects of caffeine administered in the first 2 hours versus at 12 hours of life in infants <29 weeks' gestation. Our primary hypothesis is that early caffeine administered (at < 2 hours of life) can prevent the need for endotracheal intubation in the first 12 hours of life.|First 12 hours of life||||participants|||Number
2637225|NCT01783548|Secondary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age|"Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline and the during study iTNSS values were defined as the average AM and PM subject-reported iTNSS during each time period."|Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6|Full analysis set (FAS) included all participants in the ITT population who received at least 1 dose of randomized study medication and had at least 1 post-baseline subject-reported rTNSS assessment.|||units on a scale||Standard Error|Least Squares Mean
2637235|NCT01783496|Primary|Improvement in Laxity|Improvement in facial and neck laxity 6 months following treatment as assessed by Study Investigator using a Quartile Improvement Scale score based upon a five point grading System: 4 - Very Significant Improvement (76-100%), 3 - Marked Improvement (51-75%), 2 - Moderate Improvement (26-50%), 1 - Minor/Mild Improvement (1-25%), or 0 - No Improvement.|6 months||||units on a scale||Standard Deviation|Mean
2637236|NCT01783483|Secondary|Narcotic Usage|Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .|From 3-month to 6 month post-op|Subjects with completed narcotic usage assessment from 3-month to 6-month post op: 100 Suture Wire / 102 SternaLock Blu|||milligrams of Morphine Equivalence Dose||Standard Deviation|Mean
2637226|NCT01783548|Secondary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age|"Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline and the during study rTNSS values were defined as the average AM and PM subject-reported rTNSS during each time period."|Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6|Full analysis set (FAS) included all participants in the ITT population who received at least 1 dose of randomized study medication and had at least 1 post-baseline subject-reported rTNSS assessment.|||units on a scale||Standard Error|Least Squares Mean
2637227|NCT01783548|Secondary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age|"Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline and the during study iTNSS values were defined as the average AM and PM subject-reported iTNSS during each time period."|Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6|Full analysis set (FAS). Subpopulation of study participants aged 6-11 years.|||units on a scale||Standard Error|Least Squares Mean
2637228|NCT01783548|Primary|Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age|"Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline and the during study rTNSS values were defined as the average AM and PM subject-reported rTNSS during each time period."|Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6|Full analysis set (FAS) included all participants in the ITT population who received at least 1 dose of randomized study medication and had at least 1 post-baseline subject-reported rTNSS assessment. Subpopulation of study participants aged 6-11 years.|||units on a scale||Standard Error|Least Squares Mean
2637229|NCT01783522|Secondary|Average Change in Quality of Life Scores From Baseline to End of Study|Quality of life will be measured on the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) including 26 summed items (responses 0 to 4 to equal a possible total score 0-108). Higher scores represent better quality of life. Average change in Quality of Life scores from baseline to end of study will be reported for each separate arm|from baseline to end of study at 4 months|All participants enrolled in study and given treatment.|||score on a scale||Standard Deviation|Mean
2637230|NCT01783522|Secondary|RR (Complete Remission [sCR+CR+Very Good Partial Remission [VGPR]+Partial Remission [PR])|RR (sCR+CR+VGPR+PR) according to uniform international response criteria and CBR (RR+MR according to modified EBMT criteria) will be assessed with SPEP, 24h UPEP, serum urine immunofixation, and serum free light chain assay at the start of each cycle and after completion of the 4th cycle.|up to 4 months from start of study|Subject data not collected due to low accrual. Research cancelled||||||
2637231|NCT01783522|Secondary|Adherence to Bortezomib Treatment|Adherence reported as a percentage based on number of doses of study drug taken divided by the expected number of doses of study drug expected to be taken for the study duration.|Up to 4 months|All patients enrolled in study and given treatment|||% of doses taken|||Number
2637232|NCT01783522|Primary|Degree of Peripheral Neuropathy (PNP)|The Neuropathy Impairment Score -Lower Limbs (NIS-LL) is the objective measurement of PNP symptoms. The degree of PNP will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03. The CTCAE is a 0-5 scale that assesses severity of neuropathy related to cancer therapy with higher scores meaning more symptoms A difference of 2 points between groups is considered significant. This measure will be performed at baseline and at 4 months.|up to 4 months from start of study|All participants enrolled in study and given treatment.|||units on a scale||Standard Deviation|Mean
2637233|NCT01783496|Secondary|Subject Satisfaction With Treatment Results|"subjects were asked to provide satisfaction with treatment results, using the Likert Satisfaction Scale. Scoring was based upon a five point grading System: 5 - Very Satisfied, 4 - Satisfied, 3 - Neither Satisfied nor Dissatisfied, 2 - Dissatisfied, or 1 - Very Dissatisfied.~Data are presented as the proportion of subjects showing improvement as defined as a score of 4 or greater ('satisfied' or 'very satisfied')."|6 months||||percentage of subjects satisfied|||Number
2637234|NCT01783496|Secondary|Improvement in Skin Laxity (Subject Self-assessed)|Improvement in facial and neck laxity 6 months following treatment as self-assessed by subjects using a Quartile Improvement Scale score based upon a five point grading System: 4 - Very Significant Improvement (76-100%), 3 - Marked Improvement (51-75%), 2 - Moderate Improvement (26-50%), 1 - Minor/Mild Improvement (1-25%), or 0 - No Improvement.|6 months||||units on a scale||Standard Deviation|Mean
2637578|NCT01780870|Primary|The Primary Outcome Will be Insulin Levels at Baseline and 8 Weeks|The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment|8 weeks||||μU/ml||Standard Deviation|Mean
2637237|NCT01783483|Secondary|Narcotic Usage|Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .|From 6-week to 3-month post-op|Subjects with completed narcotic usage assessment from 6-week to 3-month post op: 108 Suture Wire / 104 SternaLock Blu|||milligrams of Morphine Equivalence Dose||Standard Deviation|Mean
2637238|NCT01783483|Secondary|Narcotic Usage|Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .|From 3-week to 6-week post-op|Subjects with completed narcotic usage assessment from 3-week to 6-week post op: 115 Suture Wire / 111 SternaLock Blu|||milligrams of Morphine Equivalence Dose||Standard Deviation|Mean
2637239|NCT01783483|Secondary|Narcotic Usage|Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .|From Hospital Discharge to 3-week post-op|Subjects with completed narcotic usage assessment from hospital discharge to 3-week post op: 109 Suture Wire / 112 SternaLock Blu|||milligrams of Morphine Equivalence Dose||Standard Deviation|Mean
2637240|NCT01783483|Secondary|Narcotic Usage|Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED).|Index (Day 0 to Hospital Discharge)|Subjects with completed narcotic usage assessment from Day 0 to hospital discharge: 118 Suture Wire / 114 SternaLock Blu|||milligrams of Morphine Equivalence Dose||Standard Deviation|Mean
2637241|NCT01783483|Secondary|Pain Measured in a 10-point Scale at 6-month Post Operative|"Intensity of sternal pain assessed using 10 point scale in the following circumstances:~At rest~After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience"|6-month Post-op|"Pain assessed at resting and after forced coughing. Pain levels of 1 or more were deemed to have pain.~Subjects at 6-month post op with completed pain assessment: 96 Suture Wire / 102 SternaLock Blu"|||units on a scale 0-10||Standard Deviation|Mean
2637242|NCT01783483|Secondary|Pain Measured in a 10-point Scale at 3-month Post Operative|"Intensity of sternal pain assessed using 10 point scale in the following circumstances:~At rest~After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience"|3-month Post-op|"Pain assessed at resting and after forced coughing. Pain levels of 1 or more were deemed to have pain.~Subjects at 3-month post op with completed pain assessment 108 Suture Wire / 105 SternaLock Blu"|||units on a scale 0-10||Standard Deviation|Mean
2637243|NCT01783483|Secondary|Pain Measured in a 10-point Scale at 6-week Post Operative|"Intensity of sternal pain assessed using 10 point scale in the following circumstances:~At rest~After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience"|6-week Post-op|"Pain assessed at resting and after forced coughing. Only patients who reported pain levels of 1 or more were deemed to have pain.~Subjects at 6-week post op with completed pain assessment: 114 Suture Wire / 112 SternaLock Blu"|||units on a scale 0-10||Standard Deviation|Mean
2637244|NCT01783483|Secondary|Pain Measured in a 10-point Scale at 3-week Post Operative|"Intensity of sternal pain assessed using 10 point scale in the following circumstances:~At rest~After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience"|3-week Post-op|"Pain assessed at resting and after forced coughing. Only patients who reported pain levels of 1 or more were deemed to have pain.~Subjects at 3-week post op with completed pain assessment: 107 Suture Wire / 107 SternaLock Blu"|||units on a scale 0-10||Standard Deviation|Mean
2637245|NCT01783483|Secondary|Pain Measured in a 10-point Scale at Day 7 Post Operative|"Intensity of sternal pain assessed using 10 point scale:~At rest~After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience"|Day 7|"Pain assessed at resting and after forced coughing. Pain levels of 1 or more were deemed to have pain.~Subjects at 7-Day post op with completed pain assessment: 31 Suture Wire / 30 SternaLock Blu"|||units on a scale 0-10||Standard Deviation|Mean
2637246|NCT01783483|Primary|Sternal Healing Score at 6 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing|"Parameters for scoring:~0 - Nonunion: No contact between sternal halves, absence of gap mineralization, and sclerotic osteotomy margins similar to that of cortical bone. Worst outcome~- Indeterminate: No contact or mineralization between the sternal halves, but osteotomy margins were non-sclerotic, concave, or irregular~- Early healing: Faint mineralization between non-contacting sternal halves, or a thin (1 mm) bridge of bone connecting the sternal halves anteriorly or posteriorly, or near bone-on-bone contact between the sternal halves, with sclerotic osteotomy margins~- Mild synthesis: Bridging bone (i.e., no perceptible gap) along less than 50% of the anteroposterior dimension of the sternal halves, with the sternal halves either offset in the anteroposterior dimension, or aligned in the anteroposterior dimension~- Moderate synthesis: Bridging bone along 50% or more of the anteroposterior dimension of the sternal haves 5- Sternal halves well-aligned. Best outcome"|6-month post-op|Subjects with completed CT scan at 6 months post op: 100 Suture Wire / 101 SternaLock Blu)|||units on a scale 0-5||Standard Deviation|Mean
2637247|NCT01783483|Primary|Sternal Healing Score at 3 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing|"Parameters for scoring:~0 - Nonunion: No contact between sternal halves, absence of gap mineralization, and sclerotic osteotomy margins similar to that of cortical bone. Worst outcome~- Indeterminate: No contact or mineralization between the sternal halves, but osteotomy margins were nonsclerotic, concave, or irregular~- Early healing: Faint mineralization between noncontacting sternal halves, or a thin (1 mm) bridge of bone connecting the sternal halves anteriorly or posteriorly, or near bone-on-bone contact between the sternal halves, with sclerotic osteotomy margins~- Mild synthesis: Bridging bone (i.e., no perceptible gap) along less than 50% of the anteroposterior dimension of the sternal halves, with the sternal halves either offset in the anteroposterior dimension, or aligned in the anteroposterior dimension~- Moderate synthesis: Bridging bone along 50% or more of the antero-posterior dimension of the sternal haves 5- Sternal halves well-aligned. Best outcome"|3-month post-op|Subjects with completed CT scan at 3 month post op: 102 Suture Wire / 103 SternaLock Blu|||units on a scale||Standard Deviation|Mean
2637248|NCT01783470|Other Pre-specified|Whole-body Energy Expenditure|This is the energy expenditure as calculated using indirect calorimetry.|30 minutes before drug administration followed by 30 minutes after FDG administration|||||||
2637279|NCT01783015|Secondary|Change From Baseline in CRP|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637249|NCT01783470|Primary|BAT Activity as Measured by 18F-FDG PET/CT|difference in BAT metabolic activity measured in placebo and active drug arms. The BAT metabolic activity represents the amount of FDG tracer retained within the tissue. Retained FDG is a biomarker for tissue oxygen consumption and hence energy expenditure by the tissue.|60 min after FDG administration||||mL*SUVmean*g/mL||Inter-Quartile Range|Median
2637250|NCT01783418|Primary|Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention|"PANAS-C - Negative affect~Score range: 0 (minimum score) - 50 (maximum score) Higher scores represent worse outcomes"|Baseline, Post-intervention (8 weeks)||||units on a scale||Standard Deviation|Mean
2637251|NCT01783418|Primary|Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention|"PANAS-C - Positive affect~Score range: 0 (minimum score) - 50 (maximum score)~High scores represent better outcomes"|baseline, Post-intervention (8 weeks)||||units on a scale||Standard Deviation|Mean
2637252|NCT01783418|Primary|Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention|"Beck youth inventories - Depression scale~Subscale range: 0 (minimum score) - 60 (maximum score)~Higher scores a worse outcome"|baseline, Post-intervention (8 weeks)||||units on a scale||Standard Deviation|Mean
2637253|NCT01783418|Secondary|Changes in Mindfulness Propensity and Skills From Baseline to Post-intervention and 6 Months Post-intervention|"Children and Adolescent Mindfulness Measure Score range: 0 (minimum score) - 40 (maximum score)~Higher scores represent better outcomes"|Baseline, Post-intervention (8 weeks)||||units on a scale||Standard Deviation|Mean
2637254|NCT01783418|Primary|Changes Sleep From Baseline to Post-intervention and 6 Months Post-intervention|"Pittsburgh Sleep Quality Index~Score range: 0 (minimum score) - 21 (maximum score)~Higher scores indicate worse outcomes"|Baseline, Post-intervention (8 weeks)||||units on a scale||Standard Deviation|Mean
2637255|NCT01783418|Primary|Changes in Quality of Life From Baseline to Post-intervention and 6 Months Post-intervention|"Pediatric Cancer Quality of Life Inventory~Scale range: 0 (minimum score) to 108 (maximum score) Higher scores represent better outcomes"|Baseline, Post-intervention (8 weeks)||||units on a scale||Standard Deviation|Mean
2637256|NCT01783418|Primary|Changes in Mood From Baseline to Post-intervention and 6 Months Post-intervention|"Beck Youth Inventory - Anxiety scale Subscale range: 0 (minimum score) - 60 (maximum score)~Higher scores indicate higher anxiety and a worse outcome"|Baseline, Post-intervention (8 weeks)||||units on a scale||Standard Deviation|Mean
2637257|NCT01783236|Secondary|VAS Score 24 Hours Post-Operation|"24 Hours after the conclusion of the subject's operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled No Pain (score of 0) and Worst possible pain (score of 100)."|24 hours post-operation||||mm||Inter-Quartile Range|Median
2637258|NCT01783236|Secondary|VAS Pain Score 6 Hours Post-Operation|"6 hours after the conclusion of their operation, participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled No Pain (score of 0) and Worst possible pain (score of 100)."|6 Hours Post-Operation||||mm||Inter-Quartile Range|Median
2637259|NCT01783236|Secondary|VAS Pain Score 2 Hours Post Operation|"2 hours after the conclusion of their operation,participants were asked to draw a vertical line on the VAS to indicate their level of pain, which was then converted into millimeters for interpretations. Scores ranged from 0-100mm. VAS pain score identifies two extremes on a 10 centimeter horizontal line; the extremes are labeled No Pain (score of 0) and Worst possible pain (score of 100)."|2 Hours Post Operation||||mm||Inter-Quartile Range|Median
2637260|NCT01783236|Secondary|Total Number of PCA Requests in First 24 Hours Post-Operation|The total number of Patient Controlled Analgesic (PCA) requests in the first 24 hours after the conclusion of the subject's operation|24 hours post-operation||||PCA requests||Inter-Quartile Range|Median
2637261|NCT01783236|Primary|Total Morphine Consumption (mg)|How much morphine the subject consumes in the first 24 hours after surgery (mg).|24 hours||||mg||Inter-Quartile Range|Median
2637262|NCT01783080|Secondary|Social Functioning at Week 12 on the Social Adjustment Scale|Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning|Week 12||||unites on a scale||Standard Deviation|Mean
2637263|NCT01783080|Secondary|Social Functioning at Week Baseline on the Social Adjustment Scale|Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning|baseline||||unites on a scale||Standard Deviation|Mean
2637264|NCT01783080|Primary|Paid Work Hours at Week Baseline|Subject-reported paid work hours per week at week baseline|Baseline||||hours||Standard Deviation|Mean
2637265|NCT01783080|Primary|Paid Work Hours at Week 12|Subject-reported paid work hours per week at week 12|Week 12||||hours||Standard Deviation|Mean
2637278|NCT01783015|Secondary|Change From Baseline in Health Assessment Questionnaire Disability and Discomfort Scales (HAQ-DI)|Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637266|NCT01783054|Secondary|Number of Adverse Events Reported in Subjects Enrolled.|Assess the safety profile of this neoadjuvant regimen in patients with localized pancreatic adenocarcinoma. All toxicities will be reported by type and grade and tabulated. All adverse events will be reported via case report forms. The intensity of any adverse event should be reported according to the NCI Common Terminology Criteria for Adverse Events v4.0.|First study drug administration until end of study|All subjects who were administered study intervention and had documented adverse events were analyzed. The number below represents the number of adverse events, including serious adverse events, reported on by enrolled subjects. A complete list of the adverse events reported are in the adverse events tables of these results.|||adverse events|||Number
2637267|NCT01783054|Secondary|Estimate Median Overall Survival|Overall survival is defined as the time from enrollment to death from any cause. Patients still alive at the end of follow up will have their survival time censored at the last date of contact.|2 years|Only subjects who had surgical resection are included in the analysis for this endpoint. At the time of these results, one subject expired due to disease progression. The other subject was still alive at the time of termination, so is not included in the outcome measure data below.|||days|||Number
2637268|NCT01783054|Secondary|Estimate Median Time to Recurrence.|Time to recurrence is defined as the time from surgical resection to disease recurrence or death from any cause. Patients who have not recurred at the end of follow up will have their recurrence time censored at the last date of contact.|2 years|Only subjects who had surgical resection are included in the analysis for this endpoint. At the time of these results, one subject expired due to disease progression. The other subject was still alive at the time of termination, so is not included in the outcome measure data below.|||days|||Number
2637269|NCT01783054|Other Pre-specified|Circulating Tumor Cells (CTC)|To evaluate and describe CTC number, CTC phenotype characteristics and effectiveness/rate of CTC culturing techniquen from patients with pancreatic adenocarcinoma. To determine and evaluate the correlation between expression of biomarkers in CTCs and expression of biomarkers in resected tissue specimen with the same cancer patient.|From enrollment to surgery|This outcome measure was added as part of an amendment. No subjects were enrolled after this amendment was instituted, so no outcomes measures were collected.||||||
2637270|NCT01783054|Secondary|Number of Participants With R0 Resection Status.|R0 resection status is a macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor.|at time of surgery|Subjects who had surgical resection are included in the analysis for this endpoint.|||participants|||Number
2637271|NCT01783054|Primary|Tumor Response|Estimate the rate of good histopathologic tumor response to neoadjuvant chemotherapy assessed in resection specimen. A good response is defined as a grade III or IV histopathologic appearance, equivalent to <10% viable tumor.|at time of surgery|The study terminated early and the data for this outcome measure was not documented.||||||
2637272|NCT01783015|Secondary|Number of Participants With Positive Etanercept Neutralizing Anti-drug Antibody Status|Blood samples (6 mL) were collected at the baseline, Week 12, and Week 24 visits, or upon early withdrawal, to provide a minimum of 1 mL serum each for ETN ADA and ETN neutralizing antibody analyses. Samples which were positive for ETN anti-drug antibodies were then also tested for ETN neutralizing antibodies.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637273|NCT01783015|Secondary|Number of Participants With Positive Etanercept Anti-drug Antibody Status|Blood samples (6 mL) were collected at the baseline, Week 12, and Week 24 visits, or upon early withdrawal, to provide a minimum of 1 mL serum each for ETN ADA and ETN neutralizing antibody analyses. Samples which were positive for ETN anti-drug antibodies were then also tested for ETN neutralizing antibodies.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637274|NCT01783015|Secondary|Change From Baseline in Vectra Disease Activity Levels|The change from Baseline in Vectra disease activity levels was to be estimated. The assessment measures serum protein biomarkers associated with RA. It has a range from 1-100 with lower scores indicating the better outcome.|Baseline, 12 weeks, 24 weeks|Vectra disease activity analysis of laboratory samples was not conducted due to study termination.||||||
2637275|NCT01783015|Secondary|Change From Baseline in Patient Acceptable Symptom State (PASS)|"The Patient Acceptable Symptom State (PASS) was a participant-completed form in which participants were asked to Think about all the ways your rheumatoid arthritis (RA) has affected you during the last 48 hours. If you were to remain in the next few months as you were during the last 48 hours, would this be acceptable or unacceptable to you? The participant indicated a response of either acceptable or unacceptable."|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637276|NCT01783015|Secondary|Change From Baseline in Short Form-36 Health Survey (SF-36)|The 36-Item Short Form Health Survey (SF-36) is widely used 36-item questionnaire that measures general health-related quality of life in the following 8 domains: physical function, role limitations due to physical health, bodily pain, general health perception, vitality, social functioning, role limitation due to emotional problems, and mental health. Scores for the 8 domains range from 0 to 100 where higher scores are better.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637277|NCT01783015|Secondary|Change From Baseline in Euro Quality of Life (Qol) EQ-5 Dimensions Questionnaire (EQ-5D)|"The EuroQol-5 Dimensions (EQ-5D) is a participant-completed questionnaire designed to assess health related quality of life. There are 2 components to the EQ-5D: a Health State Profile and a VAS. For the Health State Profile, participants recorded their level of current health for 5 domains comprising a health profile: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scores from the 5 domains may be used to calculate a single index value, also known as a utility score. On the VAS participants were asked to rate their current health on a scale from 0 to 100 mm, where 0 represented the worst imaginable health state and 100 represented the best imaginable health state. In addition to a summary of mean changes, 1 categorical endpoint each based on EQ-5D utility score and 1 based on the VAS were derived and analyzed: EQ-5D utility score improvement ≥0.05 and EQ-5D VAS score >82."|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637280|NCT01783015|Secondary|Change From Baseline in Subject Pain|Subject Pain was to be measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no pain and 100 mm = most severe pain.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637281|NCT01783015|Secondary|Change From Baseline in Subject General Health VAS.|Subject General Health VAS assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637282|NCT01783015|Secondary|Change From Baseline in Subject Global Assessment of Disease Activity|Change from Baseline in Subject Global Assessment of Disease Activity was to be estimated. Participants were to assess their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity).|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637283|NCT01783015|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity|Change from Baseline in the PGA scores was to be estimated. The Study Physician estimated the participant's overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity).|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637284|NCT01783015|Secondary|Change From Baseline in Number of Swollen Joints|Change from Baseline in the number of swollen joints including shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees was to be calculated.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637285|NCT01783015|Secondary|Change From Baseline in Number of Tender/Painful Joints|Change from Baseline in the number of tender/painful joints using the 28 joint count including shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees was to be calculated.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637286|NCT01783015|Secondary|Change From Baseline in SDAI.|Change from Baseline in SDAI scores were to be calculated. The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity, and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637287|NCT01783015|Secondary|Change From Baseline in CDAI|Change from Baseline in CDAI scores was to be calculated. The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Baseline, 12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637288|NCT01783015|Secondary|Number of Participants Achieving Low Disease Activity or Remission Based on Simplified Disease Activity Index (SDAI).|The SDAI is the numerical sum of five outcome parameters: TJC) and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity, and CRP (mg/dL). SDAI total score= 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637289|NCT01783015|Secondary|Number of Participants Achieving Low Disease Activity or Remission Based on Clinical Disease Activity Index (CDAI)|The CDAI is the numerical sum of 4 outcome parameters: tender joint count (TJC) and SJC based on a 28-joint assessment, SGA and PGA assessed on 0-10 point scale; higher scores=greater affliction due to disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637290|NCT01783015|Secondary|Number of Participants Achieving European League Against Rheumatism (EULAR) Good and/or Moderate Response.|The Disease Activity Score Based on 28-joints Count based (DAS28-based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to =<5.1 or change from baseline >0.6 to =<1.2 with DAS28 =<5.1; non-responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637291|NCT01783015|Secondary|Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response|ACR90 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and ≥ 90% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637292|NCT01783015|Secondary|Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and ≥ 70% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637293|NCT01783015|Secondary|Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and ≥ 50% improvement in 3 of the 5 remaining ACR core measures: participant's assessment of pain; SGA of disease activity; PGA of disease activity; subject's assessment of functional disability via a HAQ; and CRP.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637294|NCT01783015|Secondary|Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant's assessment of pain; Subject Global Assessment (SGA) of disease activity; Physician Global Assessment (PGA) of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.|12 weeks, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637297|NCT01783015|Secondary|Change From Baseline in the DAS28 at Week 24|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the CRP and and Subject General Health VAS assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).|Baseline, 24 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637298|NCT01783015|Primary|Change From Baseline in the Disease Activity Score Based on a 28 Joint Count (DAS28-C-reactive Protein [CRP]) at Week 12.|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the c-reactive protein (CRP) and Subject General Health Visual Analogue Scale (VAS) assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).|Baseline, 12 weeks|Due to small sample size, Pfizer did not perform statistical analysis.||||||
2637299|NCT01782963|Secondary|Pharmacogenomic Markers of Neuropathy|To evaluate pharmacogenomic markers among patients with treatment related polyneuropathy.|2 years|No pharmacogenomic markers were evaluated for relation to neuropathy||||||
2637300|NCT01782963|Secondary|Mean Plasma Bortezomib Concentration Following Intravenous and and Subcutaneous Injection|The pharmacokinetic profile of intravenous and subcutaneous bortezomib administration in combination with lenalidomide and dexamethasone.|Day 1 (5 min, 30min, 5 hours post dose), Days 8, 15, Day 22 (pre dose and 5 min, 30 min, 5 hrs post dose), cycle 2 day 1 pre dose|A total of only 10 participants per arm were evaluated for drug plasma concentrations following Bortezomib administration.The number of participants vary by time-point due to missing measurements for the concentrations.|||ng/mL||Standard Deviation|Mean
2637301|NCT01782963|Secondary|Response Rate With Respect to Cytogenetic Characteristics|"Response rate was assessed using the International Myeloma Working Group uniform response criteria. Stringent complete response, Complete Response, Very Good Partial Response, and Partial Response are defined in outcome measure 1.~MR included participants in whom some, but not all, criteria for PR were fulfilled, providing the remaining criteria satisfied the requirements for MR. Required all of the following:~≥25% to ≤ 49% reduction in the level of serum monoclonal protein for at least two determinations six weeks apart.~If present, a 50 to 89% reduction in 24-hour light chain excretion, which still exceeds 200 mg/24 h, for at least two determinations six weeks apart.~25-49% reduction in the size of plasmacytomas (by clinical or radiographic examination) for at least six weeks.~No increase in size or number of lytic bone lesions (development of compression fracture does not exclude response).~Stable Disease: Not meeting the criteria for minimal response or"|2 years||||Participants|||Count of Participants
2637302|NCT01782963|Secondary|Median Time to Response|"Median amount of time from the start of treatment until first documented response as defined by the International Myeloma Working Group uniform response criteria~Stringent CR: Same as CR plus normal free light chain ratio and absence of clonal cells plasma cells in bone marrow (BM) CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in BM VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 hours. If the serum and urinary M-protein are not measurable, additional criteria are used to assess PR that will not fit in the space provided here. If present at baseline, a ≥50% reduction in the size of plasmacytomas is also required"|From the start of treatment until the time of first documented response, median duration of 1.1 months|Participants that achieved a response|||Months||95% Confidence Interval|Median
2637303|NCT01782963|Secondary|Median Overall Survival|The median overall survival as measured from the start of treatment until the time of death due to any cause.|From the start of treatment until death or until 5 years after the time of disease progression|Median overall survival was not met before the end of follow-up/ data cutoff point because more than half of the participants were still alive.|||years||95% Confidence Interval|Median
2637304|NCT01782963|Secondary|Median Progression Free Survival|"The median amount of time as measured from the start of treatment until either death or progression.~Progressive disease requires 1 or more of the following:~>=25% increase from lowest response level in serum M-protein (>=0.5 g/dL absolute increase) and/or urine M-component (>=200 mg/24hr absolute increase)~>=25% increase in the difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL). Only for use in patients without measurable serum and M-protein levels.~>=25% increase in bone marrow plasma cell percentage (absolute percentage >=10%)~New or increase in existing bone lesions or soft tissue plasmacytomas~Hypercalcemia (serum calcium >11.5 mg/dL) due solely to the plasma cell proliferative disorder."|From the start of treatment until death or progression or until 3 years after the last participant is enrolled||||Months||95% Confidence Interval|Median
2637305|NCT01782963|Secondary|Number of Participants With Grade 3 or Higher Treatment Related Adverse Events|A summary of the number of participants with grade 3 or higher treatment related adverse events for adverse events that had an overall incidence of greater than 15% (any grade) as assessed by Common Terminology Criteria for Adverse Events (CTCAE 4).|2 years||||Participants|||Count of Participants
2637306|NCT01782963|Primary|Objective Response Rate|"Participants are considered to have achieved an objective response if they meet the International Myeloma Working Group uniform response criteria for any of the following:~Stringent CR: Same as CR plus normal free light chain ratio and absence of clonal cells plasma cells in bone marrow (BM)~CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in BM~VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours~PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg per 24 hours. If the serum and urinary M-protein are not measurable, additional criteria are used to assess PR that will not fit in the space provided here. If present at baseline, a ≥50% reduction in the size of plasmacytomas is also required"|2 years||||Participants|||Count of Participants
2637321|NCT01782872|Secondary|Duration of Analgesia From Interscalene Nerve Block|Median time until a patient needed to take opioid pain medication|Postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM|Patients who were able to provide actual or estimates of time until they first needed to use pain medication were included in this analysis.|||hours||Standard Error|Mean
2637322|NCT01782872|Primary|Numeric Rating Scale (NRS) Pain Score With Movement|Pain with movement at 24 hours from the nerve block (scale of 0-10; 0 = no pain, 10 = worst possible pain)|24 hours after the interscalene block is given||||units on a scale||Standard Deviation|Mean
2637307|NCT01782898|Secondary|Post Operative Pain Reported by the Subject.|Post operative pain reported by the subject as determined as area under the numeric rating scale for pain versus time curve in the post anesthesia care unit ( score*min).Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve in the post anesthesia care unit ( score * min). A higher value indicates more pain over 24 hours.The range is 0 pain to x time in minutes x hour ( 60-1440 minutes) . The pain scores were collected at 15 minute intervals from the time of admission to the PACU to 24 hours after the surgical procedure. The area under the NRS pain scale versus time curve was calculated using the trapezoidal method as an indicator of pain burden during early recovery (Graph Pad Prism ver 5.03, Graph Pad Software INC.|24 hour||||(pain score * minutes ) in the PAC U||Inter-Quartile Range|Median
2637308|NCT01782898|Secondary|Postoperative Opioid Consumption|The total amount of opioid consumed by subject at 24 hours after surgery measured in IV morphine equivalents.|24 hours||||IV mg of morpine equivalents||Inter-Quartile Range|Median
2637309|NCT01782898|Primary|Qor-40 at 24 Hours Postoperative|"Quality of recovery questionnaire score at 24 hours after surgery. Quality of recovery score 24 hours after the surgical procedure.Score of 40 is poor recovery and a score of 200 is good recovery.~Time frame for this evaluation is 24 hours after the surgical procedure"|24 hours||||units on a scale 40 low-200 high||Inter-Quartile Range|Median
2637310|NCT01782885|Other Pre-specified|Change in SF-12v2 Health Survey|The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|24 weeks||||units on a scale||Standard Deviation|Mean
2637311|NCT01782885|Other Pre-specified|Change in SF-12v2 Health Survey|The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|12 weeks||||units on a scale||Standard Deviation|Mean
2637312|NCT01782885|Other Pre-specified|Change in SF-12v2 Health Survey|The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|6 weeks||||units on a scale||Standard Deviation|Mean
2637313|NCT01782885|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|24 weeks||||units on a scale||Standard Deviation|Mean
2637314|NCT01782885|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|12 weeks||||units on a scale||Standard Deviation|Mean
2637315|NCT01782885|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|6 weeks||||units on a scale||Standard Deviation|Mean
2637316|NCT01782885|Primary|Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC)|The WOMAC evaluation will be performed on patients who received the treatment at 0, 6, 12, 24 weeks after treatment is finished. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). A total WOMAC score is created by summing the items for all three subscales (score range 0-96). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|0 weeks||||units on a scale||Standard Deviation|Mean
2637317|NCT01782885|Other Pre-specified|Change in SF-12v2 Health Survey|The Spanish (Mexico) version of the SF-12v2 Health Survey uses 12 questions to measure functional health and well-being from the patient's point of view. All 12 items from the survey can be summarized in two main domains (physical and mental health). Physical and Mental Health Composite Scores (PCS and MCS) are computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|0 weeks||||units on a scale||Standard Deviation|Mean
2637318|NCT01782885|Secondary|Change in Visual Analog Scale (VAS)|The visual analog scale (VAS) is a psychometric response scale which measures subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their current level of pain by indicating a position along a continuous line of 10 cm. Subject is asked: on a scale of 0 to 10, with 0 being no pain and 10 being the worst pain imaginable, what you rate your current pain?|0-24 weeks||||Centimeters||Standard Deviation|Mean
2637319|NCT01782872|Secondary|Middle Deltoid|A physical assessment will be done to determine the strength of the middle deltoid muscle in the operative arm using a dynamometer|24 hours after surgery|Patients who agreed to the measurements were included in the analysis.|||kgf||Inter-Quartile Range|Median
2637320|NCT01782872|Secondary|Numeric Rating Scale (NRS) Pain Scores at Rest|Assessment of NRS pain scores (scale of 0-10; 0 = no pain, 10 = worst possible pain) at rest|Preop||||units on a scale||Inter-Quartile Range|Median
2637324|NCT01782859|Secondary|Desmosine Level (Marker of Lung Injury)|The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.|Participants will be followed from the time of surgery until discharge, expected average of 3-5 days|Desmosine levels were not analyzed.||||||
2637325|NCT01782859|Secondary|Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)|The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.|Participants will be followed from the time of surgery until discharge, expected average of 3-5 days||||picograms/milliliter||Standard Deviation|Mean
2637326|NCT01782859|Primary|Plasmin-a 2 Antiplasmin Complex (PAP)||First 24 hours after surgery||||mcg/L||Standard Deviation|Mean
2637327|NCT01782859|Primary|Serum Prothrombin Fragment 1 and 2 (PF 1.2)||First 24 hours after surgery||||pmol/mL||Standard Deviation|Mean
2637328|NCT01782833|Secondary|The Number and Percentage of Drop-out Patients According to Aes||Follow-up at least once from baseline to 16 weeks||||Participants|||Count of Participants
2637329|NCT01782833|Secondary|The Incidence Rate of Tarchycardia and Palpitation After Pletaal® SR Capsule Administration||Follow-up at least once from baseline to 16 weeks||||Participants|||Count of Participants
2637330|NCT01782833|Primary|The Incidence Rate and the Number of AE/ADRs|Incidence rates of overall AEs and ADRs that occurred during the study period|Follow-up at least once from baseline to 16 weeks||||Participants|||Count of Participants
2637331|NCT01782742|Secondary|Change in the Ratio of Beta Amyloid 42 to Beta Amyloid 40 in Non ApoE4 Carriers|This measures the change in the ratio of Beta Amyloid 42 to Beta Amyloid 40 from baseline to week 4 in non ApoE4 Carriers|Baseline to Week 4|Of the 7 total subjects who were non-ApoE carriers, only 6 subjects were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 1 subject were unsuccessful.|||ratio||95% Confidence Interval|Mean
2637332|NCT01782742|Secondary|Change in the Ratio of Beta Amyloid 42 to Beta Amyloid 40 in All Subjects|This measures the change in the ratio of Beta Amyloid 42 to Beta Amyloid 40 from baseline to week 4 in all subjects|Baseline to Week 4|There were only a total of 17 subjects who were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 3 subjects were unsuccessful.|||ratio||95% Confidence Interval|Mean
2637333|NCT01782742|Secondary|Serum Biomarker Outcome Level Changes From Baseline to Week 4 in Beta amyloid1-40 and Beta amyloid1-42 (Non ApoE4 Carriers)|Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels comprised in secondary biomarker outcomes (non ApoE4 carriers)|Baseline to Week 4|Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels in non ApoE4 carriers. Of the 7 total subjects who were non-ApoE carriers, only 6 subjects were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 1 subject were unsuccessful.|||pmol/L||95% Confidence Interval|Mean
2637334|NCT01782742|Secondary|Secondary Outcome Measuring Serum Biomarker Outcome Level Changes From Baseline to Week 4 in Beta amyloid1-40 and Beta amyloid1-42 (ALL SUBJECTS)|Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels comprised in secondary biomarker outcomes|Baseline to Week 4|Change from baseline to week 4 in beta amyloid1-40 and beta amyloid1-42 serum levels comprised in secondary biomarker outcomes in ALL SUBJECTS. There were only a total of 17 subjects who were able to provide adequate blood sample for this serum biomarker analysis. Attempts for blood sample procurement for the other 3 subjects were unsuccessful.|||pmol/L||95% Confidence Interval|Mean
2637335|NCT01782742|Primary|Primary Outcome by Genotype (HOMOZYGOTE ApoE4 CARRIERS)|"This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (HOMOZYGOTE ApoE4 CARRIERS)~There are no homozygote ApoE4 carriers on the placebo arm, therefore no data can be presented on this arm."|Baseline to Week 4|"Change in composite and regional Beta Amyloid burden on Homozygote ApoE4 carriers.~There are no homozygote ApoE4 carriers on the placebo arm, therefore no data can be presented on this arm."|||SUVr||95% Confidence Interval|Mean
2637336|NCT01782742|Primary|Primary Outcome by Genotype (HETEROZYGOTE ApoE4 CARRIERS)|This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (HETEROZYGOTE ApoE4 CARRIERS)|Baseline to Week 4|Change in composite and regional Beta Amyloid burden on Heterozygote ApoE4 carriers|||SUVr||95% Confidence Interval|Mean
2637337|NCT01782742|Primary|Primary Outcome by Genotype (ApoE4 CARRIERS)|This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (E-4 carriers)|Baseline to Week 4|Change in composite and regional Beta Amyloid burden on ApoE4 carriers|||SUVr||95% Confidence Interval|Mean
2637338|NCT01782742|Primary|Primary Outcome by Genotype (NON ApoE4 CARRIERS)|Measures changes from baseline on treatment compared to placebo at week 4 on composite and regional Beta Amyloid burden according to ApoE genotype (NON ApoE4 CARRIERS)|Baseline to Week 4|Change in composite and regional Beta Amyloid Burden on non-ApoE4 carriers|||SUVr||95% Confidence Interval|Mean
2637339|NCT01782742|Primary|Primary Outcome by Genotype (ALL SUBJECTS)|This measures the change from baseline on treatment compared to placebo at week 4 on composite and regional beta amyloid burden according to ApoE genotype (E-4 carriers compared to E-4 non-carriers)|Baseline to Week 4|Change om composite and regional Beta Amyloid burden according to ApoE genotype on ALL SUBJECTS|||SUVr||95% Confidence Interval|Mean
2637340|NCT01782742|Secondary|Change in the Activities of Daily Living (ADCS-ADL) Score in ALL Subjects From Baseline to Week 4|The ADCS-ADL is an activities-of-daily-living inventory developed by the ADCS to assess functional performance in participants with AD (Galasko et al., 1997). Using a structured interview format, study partners are queried as to whether participants attempted each item in the inventory during the prior 4 weeks and their level of performance. Overall score range from 0 meaning fully independent to 78 meaning fully dependent on assistance for activities of daily living|Baseline to Week 4||||points||95% Confidence Interval|Mean
2637391|NCT01782469|Secondary|Mean Percent Reduction in Ultrasonography Assessment Score|Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) is the ultrasonography assessment score, with a score range of 0-36.|Baseline (Visit 1) to 13 weeks|Participants with available data|||Percent reduction||Standard Deviation|Mean
2637341|NCT01782742|Secondary|Change in NPI Scores in ALL Subjects From Baseline to Week 4|The NPI is a well validated, reliable, multi-item instrument to assess psychopathology in AD based on interview with the study partner. The NPI evaluates both the frequency and severity of 10 neuropsychiatric disturbances. Frequency assessments range from 1 (occasionally, less than once per week) to 4 (very frequently, once or more per day or continuously) as well as severity (1=mild, 2=moderate, 3=severe). The overall score and the score for each subscale are the product of severity and frequency. Overall score range from 0 meaning no disturbance to 144 meaning severe disturbance|Baseline to Week 4||||points||95% Confidence Interval|Mean
2637342|NCT01782742|Secondary|Change in the Global Clinical Dementia Rating Score in ALL Subjects From Baseline to Week 4|The CDR is a clinical scale that rates the severity of dementia as absent, questionable, mild, moderate, or severe (CDR score of 0, 0.5, 1, 2, or 3, respectively). Higher score means more severe dementia rating. The score is based on interviews with the participant and study partner, using a structured interview that assesses six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.|Baseline to Week 4||||units on a scale||95% Confidence Interval|Mean
2637343|NCT01782742|Secondary|Change in ADAS-Cog Score in ALL Subjects From Baseline to Week 4|The ADAS-Cog is a psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis. A higher score indicates more impairment. Scores from the original portion of the test range from 0 (best) to 85 (worse). A positive change indicates cognitive worsening.|Baseline to Week 4||||points||95% Confidence Interval|Mean
2637344|NCT01782742|Secondary|Change in MMSE Score in ALL Subjects From Baseline to Week 4|The MMSE evaluates orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two overlapping pentagons. A lower score indicates more cognitive impairment. The lowest score that any particular person can get is 0 and the highest score is 30.|Baseline to Week 4||||points||95% Confidence Interval|Mean
2637345|NCT01782742|Primary|Drug-Placebo Difference in Change From Baseline to Week 4 in the Composite Amyloid Burden of the Brain|The primary study endpoint for all subjects is the change from baseline to Week 4 in amyloid burden as measured by standard uptake units regional (SUVr) on amyloid brain imaging obtained through 18F-AV-45 PET|Baseline to Week 4||||SUVr||95% Confidence Interval|Mean
2637346|NCT01782690|Secondary|Score in Participant Questionnaire: Quality of Life|Participant assessment of life quality under therapy. Assessment ranged from 1 (very good) to 6 (very bad). Questionnaire scores were assessed at several time points during the study.|At Weeks 4, 8, 9 and 16|Safety population included all participants who received at least one treatment with study medication.|||scores on a scale||Standard Deviation|Mean
2637347|NCT01782690|Secondary|Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation|Participant questionnaire regarding the actual side effects of therapy compared to what one expected before therapy. Assessment ranged from 1 (less than expected) to 6 (more than expected). Questionnaire scores were assessed at several time points during the study.|At Weeks 4, 8, 9 and 16|Safety population included all participants who received at least one treatment with study medication.|||scores on a scale||Standard Deviation|Mean
2637348|NCT01782690|Secondary|Score in Participant Questionnaire: What to Do in Case of Side Effect|Participant questionnaire regarding satisfaction with the information about what one should do in case of side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study.|At Weeks 4, 8, 9 and 16|Safety population included all participants who received at least one treatment with study medication.|||scores on a scale||Standard Deviation|Mean
2637349|NCT01782690|Secondary|Score in Patient Questionnaire: Possible Side Effects|Participant questionnaire regarding satisfaction with the information about possible side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study.|At Weeks 4, 8, 9 and 16|Safety population included all participants who received at least one treatment with study medication.|||scores on a scale||Standard Deviation|Mean
2637350|NCT01782690|Secondary|Time to Disease Progression|Disease progression was defined in accordance with daily routine practice.|Up to 12 months|FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.|||months||95% Confidence Interval|Median
2637351|NCT01782690|Secondary|Percentage of Participants With Best Overall Response|Best overall response was defined as complete response (CR) plus partial response (PR). Tumor evaluations were performed in accordance with daily routine practice.|Up to 12 months|FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.|||percentage of participants|||Number
2637352|NCT01782690|Secondary|Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS)|Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by ECOG-PS at baseline (0-1 versus 2). ECOG-PS 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG-PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. ECOPG-PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.|Up to 12 months|FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.|||months||95% Confidence Interval|Median
2637353|NCT01782690|Secondary|Time of Onset of Rash After Start Erlotinib Treatment|Reported is the number of days from first erlotinib treatment to first rash onset.|Up to 12 months|Safety population included all participants who received at least one treatment with study medication.|||days||Standard Deviation|Mean
2637354|NCT01782690|Secondary|Number of Dose Modifications and Dose Withdrawals of Gemcitabine|Reported is the number of dose modifications/withdrawals for gemcitabine.|Up to 12 months|Safety population included all participants who received at least one treatment with study medication|||dose modifications/withdrawals|||Number
2637355|NCT01782690|Secondary|Number of Dose Modifications and Dose Withdrawals of Erlotinib|Reported is the total number of dose modifications/withdrawals for erlotinib.|Up to 12 months|Safety population included all participants who received at least one treatment with study medication|||dose modifications/withdrawals|||Number
2637579|NCT01780870|Primary|The Primary Outcome Will be the Leptin Levels at Baseline and 8 Weeks|The secondary outcome was deleted, since it was finally not performed in the study due to problems in enrollment|8 weeks||||ng/ml||Standard Deviation|Mean
2637356|NCT01782690|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to 12 months|Safety population included all participants who received at least one treatment with study medication.|||participants|||Number
2637357|NCT01782690|Secondary|Number of Participants With Rash by Severity|Reported is the total number of participants with rash as well as the number of participants with specific forms of rash, including paronychia, dry skin and papulopustulous eczema. Severity was reported according to Common Terminology Criteria for Adverse Events version 4.0 (CTC AE 4.0): Grade 1 = mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 = moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.|Up to 12 months|Safety population included all participants who received at least one treatment with study medication.|||participants|||Number
2637358|NCT01782690|Primary|Overall Survival Stratified by Rash|Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by rash status. Participants with rash: rash = yes. Participants without rash: rash = no.|Up to 12 months|Full Analysis Set (FAS) included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.|||months||95% Confidence Interval|Median
2637359|NCT01782664|Secondary|Change From Baseline in Serum Neopterin Concentrations at Weeks 2, 4, 8 and 12|Serum Neopterin is a marker of psoriatic disease activity. Blood samples were collected for estimation of serum neoprotein concentration. Baseline was Day 1. The change from Baseline was the difference between post-Baseline and Baseline.|Baseline (pre-dose) and Weeks 2, 4, 8 and 12|ITT Population|||Nanomol per Liter (nmol/L)||Standard Deviation|Mean
2637360|NCT01782664|Secondary|Steady State Volume of Distribution (Vss) of GSK2586184|Blood samples were taken to measure plasma concentrations of GSK2586184. A two-compartment model with a three-compartment transit model was used to derive PK parameters.|Baseline (pre-dose), Day 14 (2 to 3 hour and 3 to 4 hour post-dose), Day 28 (4 to 6 hour and 6 to 8 hour post-dose), Day 56 (at anytime during clinical visit), Day 84 (1 sample to be taken at anytime during clinical visit)|PK Population|||L||Geometric Coefficient of Variation|Geometric Mean
2637361|NCT01782664|Secondary|Clearance of GSK2586184|Blood samples were taken to measure plasma concentrations of GSK2586184. A two-compartment model with a three-compartment transit model was used to derive PK parameters.|Baseline (pre-dose), Day 14 (2 to 3 hour and 3 to 4 hour post-dose), Day 28 (4 to 6 hour and 6 to 8 hour post-dose), Day 56 (at anytime during clinical visit), Day 84 (1 sample to be taken at anytime during clinical visit)|PK Population.|||Litre (L)/hr||Geometric Coefficient of Variation|Geometric Mean
2637362|NCT01782664|Secondary|Population Pharmacokinetic (PK) Derived Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Time of the Last Measureable Concentration (AUC(0-tau) of GSK2586184|Blood samples were taken to measure plasma concentrations of GSK2586184. A two-compartment model with a three-compartment transit model was used to derive PK parameters.|Baseline (pre-dose), Day 14 (2 to 3 hour and 3 to 4 hour post-dose), Day 28 (4 to 6 hour and 6 to 8 hour post-dose), Day 56 (at anytime during clinical visit), Day 84 (1 sample to be taken at anytime during clinical visit)|PK population. The PK Population comprised of all participants who were randomized and received at least one dose of study medication.|||Nanogram/milliLitre*hour (ng/mL*hr)||Geometric Coefficient of Variation|Geometric Mean
2637363|NCT01782664|Secondary|Change From Baseline of Dermatology Life Quality Index (DLQI) Score at Week 12|The DLQI was used to assess a participant's health-related quality of life. Participants completed the questionnaire to evaluate how their psoriasis affected their life over the week before the assessment took place. Each of the 10 questions was scored out of 0-3 as; 0 = Not at all, 1 = A little, 2 = A lot and 3 = Very much. The total score for the DLQI was calculated by adding up all the individual scores for each question resulting in a minimum of 0 and a maximum of 30. Higher score indicated worsening of participant's quality of life. The Baseline value was the value obtained on Day 1. The change from Baseline was the difference between post-Baseline and Baseline.|Baseline and Week 12|ITT Population. Only those participants who had a Week 12 evaluation were analyzed.|||Scores on a Scale||Standard Deviation|Mean
2637364|NCT01782664|Secondary|Itch VAS Scores at Week 2, 4, 8 and 12|The visual analogue scale (VAS) was used to assess itch. The participants rated the intensity of itch over the past week by marking a line on a 100 mm (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no noticeable itching sensation and extreme right that is 100 mm indicated maximum itching sensation. This scale has no subscales. The participant perception of their symptoms was measured using the VAS itch score. Itch VAS scores at Week 2, 4, 8 and 12 are reported.|Week 2, 4, 8 and 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Deviation|Mean
2637365|NCT01782664|Secondary|Change From Baseline in the Itch Visual Analogue Scale (VAS) Score at Week 2, 4, 8 and 12|The visual analogue scale (VAS) was used to assess itch. The participants rated the intensity of itch over the past week by marking a line on a 100 millimeter(mm) (0 to 100 mm) long scale. A line placed on the extreme left, that is 0 mm indicated no noticeable itching sensation and extreme right that is 100 mm indicated maximum itching sensation. This scale has no subscales. The participant perception of their symptoms was measured using the VAS itch score. The Baseline value was the value obtained on Day 1. The change from Baseline was the difference between post-Baseline and Baseline.|From Baseline (Day 1) until Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Deviation|Mean
2637392|NCT01782469|Primary|Mean Change in Synovitis Measured by B-modal Ultrasonography Assessment Score After 13 Weeks of Treatment With Adalimumab.|Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle) on both left and right sides is the ultrasonography assessment score, with a score range of 0-36.|Baseline (Visit 1) to 13 weeks|Participants with available data|||units on a scale||Standard Deviation|Mean
2637366|NCT01782664|Secondary|Time to PGA Score of 'Clear' (0) or 'Almost Clear' (1)|The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale)4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). The Baseline value was the value obtained on Day 1. The scores were reported with the last observation carried forward (LOCF) analysis.|From Baseline (Day 1) until Week 12|ITT Population. Only participants achieving a PGA score of 'Clear' or 'Almost Clear' were analyzed.|||Days||Full Range|Median
2637367|NCT01782664|Secondary|Time to PASI 75|PASI 75 was >= 75% improvement from Baseline in PASI score. Psoriatic lesions were assessed by the investigator using a PASI score. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline was Day 1.|From Baseline (Day 1) until Week 12|ITT Population. Only participants achieving PASI 75 were analyzed.|||Days||Full Range|Median
2637368|NCT01782664|Secondary|Percentage of Participants in Each PGA Score Category at Weeks 2, 4, 8 and 12|The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale), 4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). Higher scores indicated worse psoriasis. The Baseline value was the value obtained on Day 1. The scores were reported with the last observation carried forward (LOCF) analysis.|Weeks 2, 4, 8 and 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of Participants|||Number
2637369|NCT01782664|Secondary|Percentage of Participants Who Had a Physician Global Assessment (PGA) Score of 'Clear' (0) or 'Almost Clear' (1) at Weeks 2, 4, 8 and 12|The severity of psoriatic lesions over the whole body were assessed by the investigator using the PGA scoring system. A 0 to 6 point rating scale was used, as follows: 0 = Clear (no signs of psoriasis), 1 = Almost clear (slight elevation, scale and/or erythema), 2 = Mild (mild plaque elevation, scale and/or erythema), 3 = Mild to moderate (mild plaque elevation with moderate erythema and/or scale), 4 = Moderate (moderate plaque elevation, scale and/or erythema), 5 = Moderate to severe (marked plaque elevation, scale and/or erythema), 6 = Severe (very marked plaque elevation, scale and/or erythema). Higher scores indicated worse psoriasis. The Baseline value was the value obtained on Day 1. The scores were reported with the last observation carried forward (LOCF) analysis.|Weeks 2, 4, 8 and 12|ITT Population|||Percentage of Participants|||Number
2637370|NCT01782664|Secondary|Percentage of Participants Who Had a PASI Score With 50%, 75% and 90% Improvement From Baseline Until Week 12|Psoriatic lesions were assessed using the PASI. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline was Day 1.|From Baseline (Day 1) until Week 12|ITT Population.|||Percentage of Participants|||Number
2637371|NCT01782664|Secondary|PASI Score at Week 2, 4, 8 and 12|Psoriatic lesions were assessed using the PASI. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1.|Week 2, 4, 8 and 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Deviation|Mean
2637372|NCT01782664|Secondary|Change From Baseline (BL) in the PASI Score at Week 2, 4, 8 and 12|Psoriatic lesions were assessed using the PASI. PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1. The change from Baseline was the difference between post-Baseline and Baseline.|From Baseline (Day 1) until Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a Scale||Standard Deviation|Mean
2673271|NCT01462877|Secondary|Change in Serum Aspartate Aminotransferase|Blood tests|Baseline up to 8 weeks after intervention|Safety set|||percentage of AST change||Full Range|Median
2637373|NCT01782664|Secondary|Number of Participants With the Indicated Maximum Change From Baseline in the Electrocardiogram (ECG) Findings|ECG measurements were obtained using single 12-lead ECGs with the participant in a supine position after resting in this position for at least 10 minutes. The Baseline values were those values obtained Pre-dose on Day 1. The change from Baseline was the difference between post-Baseline and Baseline. The QT intervals (milliseconds [msec]) corrected for heart rate using Bazett's formula (QTcB) and Fridericia's formula (QTcF) are reported.|From Baseline (Day 1) until the Follow-up visit (Day 112)|ITT Population.|||Participants|||Count of Participants
2637374|NCT01782664|Secondary|Change From Baseline in Body Temperature|Vital sign monitoring included body temperature measurements. Body temperature measurements were taken in the supine position after 5 minutes of rest. Baseline is defined as the last result on or before the day of first dose. Change from Baseline was determined by subtracting the indicated time point value minus the Baseline value.|From Baseline (Day 1) until Week 16|ITT Population. Only those participants available at the specified time points were analyzed.|||Celsius||Standard Deviation|Mean
2637375|NCT01782664|Secondary|Number of Participants With the Heart Rate Falling Outside the Clinical Concern Range at Any Time Post-Baseline (BL) During the Study|"Vital sign monitoring included heart rate (HR) measurements. HR measurements were taken in supine position after 5 minutes of rest. The number of participants with HR outside the clinical concern range at any time post-BL are presented. HR low was any HR less than 40 beats per minute (bpm) and high was any HR greater than 110 bpm. The BL values were those values obtained at Day 1. Anytime post-BL assessments included any scheduled and unscheduled post-BL assessment."|From Baseline (Day 1) until the Follow-up visit (Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2637376|NCT01782664|Secondary|Number of Participants With the Systolic (S) and Diastolic (D) Blood Pressure (BP) Falling Outside the Clinical Concern Range at Any Time Post-baseline During the Study|"Vital sign monitoring included systolic and diastolic BP measurements. BP measurements were taken in the supine position after 5 minutes of rest. The number of participants with the SBP or DBP outside the clinical concern range at any time post-BL are presented. SBP low was measured as less than 85 millimeters of mercury (mmHg)and high was measured as greater than 160 mmHg. DBP low was measured as less than 45 mmHg and high was measured as greater than 100 mmHg. The BL values were those values obtained at Day 1. Anytime post-BL assessments included any scheduled and unscheduled post-BL assessment."|From Baseline (Day 1) until the follow-up visit (Day 112)|ITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2637377|NCT01782664|Secondary|Number of Participants With the Indicated Clinical Chemistry Parameters Falling Outside the Reference Range at Any Time Post-Baseline (BL) During the Study|Safety and tolerability were assessed by measuring the clinical chemistry parameters such as creatinine and cystatin C. BL values were obtained at Day 1. The number of participants with the indicated hematology parameter data outside of the reference range (> high or < low) at any time post-BL, including unscheduled or scheduled assessments, are presented.|From Baseline (Day 1) until the Follow-up visit (Day 112)|ITT population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2637378|NCT01782664|Secondary|Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline (BL) During Study|Hematology parameters included: basophils, eosinophils, erythrocyte mean corpuscular hemoglobin (EMCHb) EMCHb concentration (EMCHbC), erythrocyte mean corpuscular volume (EMCV), erythrocyte sedimentation rate (ESR), erythrocytes, hematocrit (fraction 1), hemoglobin, leukocytes, lymphocytes, monocytes, neutrophils, segmented neutrophils, platelets, reticulocytes. BL values were obtained at Day 1. The number of participants with the indicated hematology parameters data outside of the reference range (with high and low) any time post-BL are presented. Anytime post-BL assessments included any scheduled and unscheduled post-BL assessment.|From BL (Day 1) until the Follow-up visit (Day 112)|ITT Population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
2637379|NCT01782664|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect. Any SAEs assessed as related to study participation (e.g. study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK product was recorded from the time a participant consents to participate in the study up to and including any follow-up contact.|From Baseline (Day 1) until the Follow-up visit (Day 112)|ITT Population|||Participants|||Number
2637380|NCT01782664|Primary|Percentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)|PASI score was determined by evaluation of BSA covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1. Percentage of participants who achieved >= 75% improvement from Baseline was reported with LOCF analysis.|Baseline and Week 12|Per-Protocol Population: Participants in the ITT analysis set who had no major protocol deviations.|||Percentage of participants|||Number
2637393|NCT01782378|Secondary|Multidimensional Fatigue Inventory, Mental Fatigue|Mental Fatigue subscale measures mental fatigue levels; lower = better outcome; sum of items numbers 7, 11, 13 and 19 (max = 5, min =0 for each item) Max possible sum is 20.|1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data points|||units on a scale||Standard Deviation|Mean
2637381|NCT01782664|Primary|Percentage of Participants Who Had Achieved >=75% Improvement From Baseline in the Psoriasis Area Severity Index (PASI) Score at Week 12 (PASI 75)|PASI score was determined by evaluation of body surface area (BSA) covered by plaque psoriasis in 4 areas (head/neck, arms, trunk and legs with area score of 0.1, 0.2, 0.3 and 0.4 respectively). This test included combination of both degree of involvement (assessed as per the % of affected body area using a 7-point scale such that 0=0% involvement, 1=1-9%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89% and 6=90-100%) and severity (evaluated individually using a 5-point scale that ranged as 0=No evidence of sign, 1=slight evidence, 2=moderate evidence, 3=marked evidence and 4=very marked, most severe evidence of sign) of erythema, induration and desquamation in each of the same 4 areas. PASI score ranges from 0(no psoriasis) to 72(worse psoriasis). Final PASI=(sum of severity score for each area)x(% body affected score x area score). Baseline=Day 1. Percentage of participants who achieved >= 75% improvement from Baseline was reported with last observation carried forward (LOCF) analysis.|Baseline and Week 12|Intent-to-Treat (ITT) Population: participants who received at least one dose of study medication.|||Percentage of participants|||Number
2637382|NCT01782495|Secondary|Percentage of Participants With Post-treatment Relapse|Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.|From the end of treatment through 12 weeks after the last dose of study drug|All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit.|||percentage of participants||95% Confidence Interval|Number
2637383|NCT01782495|Secondary|Percentage of Participants With On-treatment Virologic Failure|On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or confirmed HCV RNA ≥ LLOQ at any point during treatment after HCV RNA < LLOQ, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment.|Up to 12 weeks (for 12-week treatment) or 24 weeks (for 24-week treatment)|All participants who received at least 1 dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
2637384|NCT01782495|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-treatment (SVR24)|SVR24 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 24 weeks after the last dose of study drug. Participants with missing data after backward imputation were imputed as nonresponders.|24 weeks after the last actual dose of study drug|All participants who received at least 1 dose of study drug (ITT population).|||percentage of participants||95% Confidence Interval|Number
2637385|NCT01782495|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)|SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. Participants with missing data after backward imputation were imputed as nonresponders.|12 weeks after the last actual dose of study drug|Intent-to-treat (ITT) population: All participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2637386|NCT01782482|Secondary|Positive Purchase Intent|"As reported on a questionnaire in response to, Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses? The binary 'positive' vs 'negative' response variable was derived from a 5-point Likert scale. Positive purchase intent is reported as the percentage of participants choosing Definitely would purchase or Probably would purchase."|Day 7|The analysis population includes all randomized participants who satisfied specific Inclusion/Exclusion Criteria, did not sleep overnight in study lenses, and used only the habitual lens care during the study. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.|||Percentage of participants|||Number
2637387|NCT01782482|Primary|Subjective Rating of Overall Satisfaction|Overall satisfaction, as rated by the participant on a 10-point scale, with 1 being very dissatisfied to 10 being very satisfied. The participant rated both eyes together by providing one single rating.|Day 7|The analysis population includes all randomized participants who satisfied specific Inclusion/Exclusion Criteria, did not sleep overnight in study lenses, and used only the habitual lens care during the study. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.|||Units on a scale||Standard Error|Mean
2637388|NCT01782469|Secondary|Mean Change in Health Assessment Questionnaire (HAQ) Score|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from Baseline in the overall score indicate improvement. Due to an error, HAQ data was not collected at 13 weeks.|Baseline (Visit 1) to 13 weeks|Due to an error, HAQ data was not collected at 13 weeks. Therefore, only baseline data are reported.|||units on a scale||Standard Deviation|Mean
2637389|NCT01782469|Secondary|Percentage of Participants Who Achieved ≥ 20% Improvement in Both Tender Joint Count (TJC) and Swollen Joint Count (SJC)|The American College of Rheumatology TJC and SJC was administered at each study visit. Participants were evaluated for tenderness and pain in 66 different joints when in motion (TJC), and 68 different joints were evaluated for swelling (SJC).|Baseline (Visit 1) to 13 weeks|All enrolled participants|||percentage of participants||95% Confidence Interval|Number
2637390|NCT01782469|Secondary|Mean Number of Joints With Detected Erosions|A total of 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) were assessed by ultrasonography at each study visit and the number of joints with erosion (wearing away) was documented.|Baseline (Visit 1) to 13 weeks|Participants with available data|||joints||Standard Deviation|Mean
2637792|NCT01777932|Secondary|Participants With Proteinuria at Study Entry (Baseline)|The number of participants with proteinurea status as positive, negative or missing is reported.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure|||participants|||Number
2637394|NCT01782378|Secondary|Multidimensional Fatigue Inventory, Reduced Motivation Activity|Reduced Motor Activity subscale measures if fatigue affects motivation levels; lower score = better outcome; sum of items numbers 4, 9, 15, and 18 (max = 5, min =0 for each item) Max possible sum is 20.|1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data points|||units on a scale||Standard Deviation|Mean
2637395|NCT01782378|Secondary|Multidimensional Fatigue Inventory, Reduced Activity Score|Reduced Activity Subscale measures fatigue levels during activity; lower = better outcome; sum of items numbers 3, 6, 10 and 17 (max = 5, min =0 for each item) Max possible sum is 20.|1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data points|||units on a scale||Standard Deviation|Mean
2637396|NCT01782378|Secondary|Multidimensional Fatigue Inventory, Physical Score|Physical Score Subscale Measures Physical Fatigue Levels; lower = better outcome; sum of items numbers 2, 8, 14 and 20 (max = 5, min =0 for each item)|1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data points|||units on a scale||Standard Deviation|Mean
2637397|NCT01782378|Secondary|Multidimensional Fatigue Inventory (MFI), General Score|Measures General Fatigue Levels; lower = better; General Fatigue Subscale = sum of items numbers 1, 5, 12 and 16 (max = 5, min =0 for each item) Max possible sum is 20.|1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data points|||units on a scale||Standard Deviation|Mean
2637398|NCT01782378|Secondary|Short Form-36V Plus (MCS)|36 Question General Health Survey/Questionnaire for Veterans; Mental Composite Score (MCS) measures endorsement of mental health symptoms which affect 7-areas (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health); Z-Score; lower score is better (based on scoring of the Veterans RAND 36 item Health Survey (SV-36) formerly Veterans SF-36.|within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment|missing data points|||Z-Score||Standard Deviation|Mean
2637399|NCT01782378|Secondary|Short Form-36V Plus (PCS)|36 Question General Health Survey/Questionnaire for Veterans; Physical Composite Score (PCS) measures endorsement of physical health symptoms related to physical problems which affect 7-areas (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health); Z-Score; lower = better outcome.|within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment|missing data points|||Z-Score||Standard Deviation|Mean
2637400|NCT01782378|Secondary|Karolinska Sleepiness Scale|Measure of Sleepiness; Participant indicates current level of sleepiness on a scale of 0 extremely alert to 10 extremely sleepy; lower score = better outcome|1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data points|||score on a scale||Standard Deviation|Mean
2637401|NCT01782378|Secondary|Pittsburgh Sleep Quality Index (PSQI)|Global Sleep Score with min score of 0 and max score of 27; lower score = better outcome 9 item questionnaire- make up 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction) with a min of 0 and max of 3 per component. Global score is total of the 7 component scores.|1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data points|||units on a scale||Standard Deviation|Mean
2637402|NCT01782378|Secondary|Short Form McGill Pain Questionnaire|Short Form McGill Pain Questionnaire; Pain Rating (for the last 30 days) with min 0 and max 45; lower = better outcome Participant rates 15 types of pain (None = 0, mild = 1, moderate = 2, severe = 3). Totaled for all types of pain.|within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data points|||units on a scale||Standard Deviation|Mean
2637403|NCT01782378|Secondary|Visual Analog Pain Rating|Visual Analog Pain Rating Scale (VAS); Current Pain Rating scale of 1-10; lower score = better outcome *must be lower than 7 at entry into study for study inclusion Participant rates current level of pain (includes body, muscular, headache etc) by marking a line on a continuous scale from 1-10.|within 1-2 weeks of LED treatment, within 1 Week and 1 Month after the last LED treatment|missing data points|||units on a scale||Standard Deviation|Mean
2637404|NCT01782378|Secondary|PCL-Civilian Survey|Post Traumatic Stress Disorder 17-item, symptom questionnaire; higher scores indicates greater endorsement of symptoms with min 17 and max 85; Reliable decrease 5-10; Clinically meaningful decrease 10-20 points (Monson et al., 2008); Lower scores = better outcome Score ranges from 1-5 for each item.|within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data points|||units on a scale||Standard Deviation|Mean
2637405|NCT01782378|Secondary|Beck Depression Inventory (BDI)|BDI; 21 item Questionnaire; Mood. With min 0 and max 63; 0-13 minimal; 14-19 mild, 20-29 moderate, 30-63 severe; lower scores = better outcome Score per item: 1-3|within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data points|||units on a scale||Standard Deviation|Mean
2637406|NCT01782378|Primary|ROCFT, Delayed Recall|"Rey Osterrieth Complex Figure Test (ROCFT); Delayed (20-min) Recall measures Visuospatial memory with min 0 and max 36; higher = better outcome Participant is asked to draw the figure from memory after a 20 minute delay (other tasks completed during this time).~Figure has 18 units; Scoring is based on accuracy and placement: 0 if unrecognizable or omitted, .5 recognizable, 1 either accurate or correctly placed or 2 both accurate and correctly placed, per unit."|within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data point|||units on a scale||Standard Deviation|Mean
2637407|NCT01782378|Primary|Rey Osterrieth Complex Figure Test (ROCFT); Immediate Recall|"ROCFT; Immediate Recall measures Visuospatial memory with min 0 and max 36; higher score better outcome Participant is presented with a figure. They are asked to copy the figure. Then they are immediately asked to recall and draw the figure.~Figure is scored on 18 units; up to 2 points per unit Scoring based on accuracy and placement of figure parts: A score of 0, 0.5 recognizable and incorrectly placed, 1 accurate or correctly placed or 2 both accurate and correctly placed; 0 is given if part is omitted or unrecognizable."|within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data points|||units on a scale||Standard Deviation|Mean
2637580|NCT01780662|Secondary|Number of Patients With FcyRIIIa-158 V/F (Valine/Phenylalanine) Polymorphism|Among patients who received 1.8mg/kg dose, the frequency of the FcγRIIIa-158 V/F polymorphism are described.|From the end of first dose to the end of last dose (Up to 13 Months)|4 eligible patients did not consent for genetic studies.|||Participants|||Count of Participants
2637408|NCT01782378|Primary|Conner's Continuous Performance Test II (CPT), D'|Conner's Continuous Performance Test II (CPT); D' (sensitivity index) (Administered on laptop computer) measures Selective and Sustained Attention; ability to detect the signal (x) within noise; values range -2 to 2; higher value better Value d' is a measure of the difference between the signal (X) and noise (non-target letters) distributions, assessing the participant's discriminative power.|within 1 week before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data points|||difference between distributions||Standard Deviation|Mean
2637409|NCT01782378|Primary|CPT Correct Detections, Reaction Time (RT)|Conner's Continuous Performance Test II; Mean Correct Detections, Reaction Time, (Administered on laptop computer) measures Selective and Sustained Attention; shorter = better outcome Participant must press the space bar when they see an X. Reaction Time for correct responses only.|within 1 week before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data points|||seconds||Standard Deviation|Mean
2637410|NCT01782378|Primary|Conner's Continuous Performance Test II (CPT) False Alarms|CPT; False Alarms (Administered on laptop computer) measures Selective and Sustained Attention percent errors; lower = better outcome Participant presses space bar when an X appears on screen. False alarms is number of errors made (responding to non-targets), reported as percentage.|within 1 week before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data points|||percent errors||Standard Deviation|Mean
2637411|NCT01782378|Primary|CVLT-II Long Delay Cued Recall|California Verbal Learning Test- II, Long Delay (20 min) Cued Recall measures Memory; with a min score of 0 and a max score of 16; higher score = better outcome After 20 minute delay participant is given cues (4 categories) and asked to recall the words within each category. Total number of items recalled across all categories.|within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment|missing data points|||units on a scale||Standard Deviation|Mean
2637412|NCT01782378|Primary|CVLT-II Long Delay Free Recall|California Verbal Learning Test- II, Long Delay (20 min) Free Recall, measures Memory with a min score of 0 and a max score of 16; higher score = better outcome After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled.|within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment|missing data points|||units on a scale||Standard Deviation|Mean
2637413|NCT01782378|Primary|CVLT-II, Short Delay Cued Recall|California Verbal Learning Test -II, Short Delay Cued Recall, measures Learning/Memory; with a min score of 0 and a max score of 16; higher score = better outcome Participants are now asked to recall items from list A again, but are given cues by category. (4 categories, 4 items each). Total is score across all 4 categories.|within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment|missing data points|||units on a scale||Standard Deviation|Mean
2637414|NCT01782378|Primary|CVLT-II, Short Delay Free Recall|California Verbal Learning Test -II, Short Delay Free Recall, measures Memory; with min score of 0 and a max score of 16; higher score = better outcome A second list B is presented for one trial of recall before asking participants to recall items from the first list A. Number of items recalled from list A is scored.|within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment|missing data points|||units on a scale||Standard Deviation|Mean
2637415|NCT01782378|Primary|California Verbal Learning Test -II (CVLT-II) Total Trials 1-5|CVLT-II Total Trials 1-5, measures Learning/Memory over 5 consecutive trials; with a min score of 0 and a max score of 80; higher score = better outcome Participant must immediately recall words from a 16 word list A read aloud by the examiner. The same list is presented for each of the 5 trials. Total across 5 trials is scored.|within 1-2 weeks before LED treatment series; within 1 Week and 1 Month after the last LED treatment|missing data points|||units on a scale||Standard Deviation|Mean
2637416|NCT01782378|Primary|Stroop Inhibition/Switching|Color-Word Interference Test Trial 4 (Inhibition/Switching); measures Attention/Executive Function Reaction Time lower = better outcome Participants must sometimes name the color ink in which the word (color) is printed or, if there is a box around the word, they must read the word.|Within 1-2 weeks before LED treatment series, within 1 week and 1 month after LED treatment series|missing data points|||seconds||Standard Deviation|Mean
2637417|NCT01782378|Primary|Stroop Inhibition (Trial 3)|Color-Word Interference Test Trial 3; measures Attention/Executive Function; inhibition Reaction Time lower = better outcome Name the color ink each word is printed in for a series of words, as quickly as possible.|Within 1-2 weeks before LED treatment series, within 1 week and 1 month after LED treatment series|missing data points|||seconds||Standard Deviation|Mean
2637418|NCT01782378|Primary|Trails Condition 4|Delis-Kaplan Executive Function (DEKFS) Trails 4; Number-Letter Switching; measures Attention/Executive Function Reaction Time lower is better Connect numbers and letters, alternating between numbers and letters. (1-A-2-B...) as quickly as possible. Ends at P.|within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data points|||seconds||Standard Deviation|Mean
2637419|NCT01782378|Primary|Trails Condition 2|Delis-Kaplan Executive Function (DKEFS) Trails 2; Number Sequencing; measures Attention/Executive Function Reaction Time with lower = better outcome Connect the numbers in consecutive order from 1 to 16, as quickly as possible.|within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data points|||seconds||Standard Deviation|Mean
2637420|NCT01782378|Primary|Digit Span Total Forward + Backwards|Total (Forwards+Backwards); measures Attention/Executive Function; working memory with a min score of 0 and a max score of 28; higher score = better outcome|within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data points|||units on a scale||Standard Deviation|Mean
2637421|NCT01782378|Primary|Digit Span Backwards|Repeat a series of numbers, in reverse order. Starts with 2 digits and continues to 7 digits in a row. Participant is given 2 attempts at each level. If 0/2 attempts are correct for a given level, the test is discontinued. Scoring: 2 points both trials correct for each set; 1point 1 trial correct; 0 points no trials Backwards; measures Attention/Executive Function with a min score of 0 and a max score of 14; higher score = better outcome|within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data points|||units on a scale||Standard Deviation|Mean
2641796|NCT01741688|Secondary|Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis|Systemic manifestation measured by C-reactive protein levels > 3|At baseline||||percentage of participants|||Number
2637422|NCT01782378|Primary|Digit Span Forwards|Repeat a series of numbers, exactly as spoken, in the same order. Starts with 2 digits and continues to 7 digits in a row. Participant is given 2 attempts at each level. If 0/2 attempts are correct for a given level, testing is discontinued. Scoring: 2 points both trials per set; 1 point 1 trial; 0 points failed both trials Forwards; measures Attention/Executive Function with a min score of 0 and a max score of 14; higher score = better outcome|within 1-2 weeks before LED treatment series, within 1 Week and 1 Month after the last LED treatment|missing data points|||units on a scale||Standard Deviation|Mean
2637423|NCT01782326|Secondary|Number of Patients With Adverse Events, Serious Adverse Events, and Death|The overall rate of adverse events reported from initiation through 30 days post last dose.|52 weeks of treatment + 30 days|The Safety set:all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no AEs also constituted a safety assessment. Only deaths occurring on treatment + 30 days after end of treatment were included|||Number of participants|||Number
2637424|NCT01782326|Secondary|Change From Baseline in Forced Vital Capacity|Change from baseline in trough value (average of values measured 45 and 15 minutes prior to the morning dose). Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at screening, screening inhaled corticosteroid (ICS) use, region, baseline FVC * visit interaction, and visit, treatment * visit interaction|4 Weeks, 12 Weeks, 26 Weeks, 38 Weeks, 52 Weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included|||Liters||Standard Error|Least Squares Mean
2637425|NCT01782326|Secondary|Change From Baseline in the Safety of QVA149 ((110/50 μg o.d.) vs Fluticasone/Salmeterol (500/50μg Bid) in Terms of HPA Axis Function, as Determined by Collection of 24-hour Urine Cortisol.|Urine cortisol/creatinine ratio|Baseline, 52 Weeks|Urine cortisol set is the subset of patients who were measured with 24-hour Urine cortisol, a subset of safety set. The safety set included all patients who received at least one dose of study drug. At the post-baseline timepoint only patients with a value at both baseline and the post-baseline timepoint are included.|||ng/mL||Full Range|Median
2637426|NCT01782326|Secondary|Change From Baseline in the Number of Puffs of Rescue Medication|A linear mixed model (LMM) was used for this analysis Change from baseline in mean number of puffs. LMM including: treatment, baseline value, smoking status at screening, ICS use at screening, airflow limitation severity, region and random effect of center nested within region.|Baseline, 52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Only FAS patients with non-missing values for all terms in LLM are included.|||Number of puffs per day||Standard Error|Least Squares Mean
2637427|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Score on a scale||Standard Error|Least Squares Mean
2637428|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 38 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Score on a scale||Standard Error|Least Squares Mean
2637429|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 26 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Score on a scale||Standard Error|Least Squares Mean
2637438|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, region, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, day 1 (30 min and one hour post dose)|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and did not have any major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Liters||Standard Error|Least Squares Mean
2637430|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 12 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Score on a scale||Standard Error|Least Squares Mean
2637431|NCT01782326|Secondary|Change From Baseline in Total St. George's Respiratory Questionnaire Score|The St. George Respiratory Questionnaire C (SGRQ-C) is a disease-specific measure of health status for use in COPD that was used to provide the health status measurements in this study. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline SGRQ-C total score, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, airflow limitation severity, visit, treatment*visit Interaction, baseline SGRQ-C total score*visit + region. lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. A negative change from baseline indicates improvement.|Baseline, 4 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Only FAS patients with non-missing values for all terms in MMRM are included.|||Score on a scale||Standard Error|Least Squares Mean
2637432|NCT01782326|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second AUC (0-12h)|"Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time"|Baseline, 52 weeks|Serial spirometry set - Serial spirometry set includes the patients who performed additional serial spirometry, a subset of FAS. Only patients with non-missing values for all terms in MMRM are included.|||Liters||Standard Error|Least Squares Mean
2637433|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Liters||Standard Error|Least Squares Mean
2637434|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 38 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Liters||Standard Error|Least Squares Mean
2637435|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 26 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Liters||Standard Error|Least Squares Mean
2637436|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 12 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Liters||Standard Error|Least Squares Mean
2637437|NCT01782326|Secondary|Forced Expiratory Volume in 1 Second|Change from baseline in trough value. Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, airflow limitation severity, visit, treatment-by-visit interaction, and baseline FEV1-by-visit interaction.|Baseline, 4 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and no major GCP violations. Only FAS patients with non-missing values for all terms in MMRM are included.|||Liters||Standard Error|Least Squares Mean
2637439|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days|Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.|||Days||95% Confidence Interval|Median
2637440|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbations Requiring Hospitalization|Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.|||Days||95% Confidence Interval|Median
2637441|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics|Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.|||Days||95% Confidence Interval|Median
2637442|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids|Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. COPD exacerbations starting between first dose and one day after date of last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.|||Days||95% Confidence Interval|Median
2637443|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations Requiring Re-hospitalization Within 30 Days|Re-hospitalizations are defined as hospitalizations starting within the first 30 days after a severe COPD exacerbation and between first dose and one day after date of last treatment. Generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included.|||COPD Exacerbation/year||Standard Deviation|Mean
2637444|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations Requiring Hospitalization. COPD Exacerbations Starting Between First Dose and One Day After Last Treatment Are Included.|All exacerbations requiring hospitalization are considered severe according to protocol definitions so this is the rate of severe COPD exacerbations only. Note - an ER visit of longer than 24 hours was considered a hospitalization.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included.|||COPD Exacerbation/year||95% Confidence Interval|Least Squares Mean
2637445|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Antibiotics|Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used. COPD exacerbations starting between first dose and one day after last treatment are included .|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Only FAS patients with non-missing values for all terms in negative binomial model are included.|||COPD Exacerbation/year||95% Confidence Interval|Least Squares Mean
2637446|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations Requiring Treatment With Systemic Corticosteroids|COPD exacerbations starting between date of first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event with the worst severity. Estimates are from a generalized linear model assuming a negative binomial distribution with fixed effects of treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included.|||COPD Exacerbation/year||95% Confidence Interval|Least Squares Mean
2637447|NCT01782326|Secondary|Time to First Moderate to Severe COPD Exacerbation.|First COPD exacerbations starting between first dose and one day after last treatment are included. Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region.|52 weeks.|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in the Cox regression model are included.|||Days||95% Confidence Interval|Median
2637448|NCT01782326|Secondary|Rate of Moderate to Severe COPD Exacerbations.|COPD exacerbations starting between date of first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event with the worst severity. A COPD exacerbation of moderate severity meets the symptoms definition in the protocol and requires treatment with systemic corticosteroids and/or antibiotics. A severe COPD exacerbation requires hospitalization. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. The offset variable log(exposure time in years) was used.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in negative binomial model are included.|||COPD Exacerbation/year||95% Confidence Interval|Least Squares Mean
2637449|NCT01782326|Secondary|Time to First COPD Exacerbation.|First COPD exacerbations starting between first dose and one day after last treatment are included. Cox regression model includes terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug and had no major GCP violations. Only FAS patients with non-missing values for all terms in Cox regression model are included.|||Days||95% Confidence Interval|Median
2637450|NCT01782326|Primary|Rate of COPD Exacerbations|COPD exacerbations starting between first dose and one day after last treatment are included. COPD exacerbations that occurred within 7 days of each other are collapsed as one event. Estimates are from a generalized linear model assuming a negative binomial distribution with terms for treatment, baseline total symptom score, baseline COPD exacerbation history (i.e. number of COPD exacerbations during the past 12 months prior to study), smoking status at screening, ICS use at screening, airflow limitation severity, and region. As the offset variable log(exposure time in years) was used.|52 weeks|The per-protocol set (PPS) included all patients in the FAS without any major protocol deviations. Only PPS patients with non-missing values for all terms in negative binomial model are included.|||COPD Exacerbations/year||95% Confidence Interval|Least Squares Mean
2637451|NCT01782313|Post-Hoc|Number of Patients With 0-3 PDGFR Alpha and PDGFR Beta Protein Expression and Time in Days on Treatment|"Tissue from biopsy will be collected during screening and proteins (PDGFR alpha and PDGFR beta) will be evaluated to see if there is a correlation with patient response to treatment.~PDGFR= Platelet derived growth factor receptor~To determine if there was a correlation between response to Tivozanib and PDGFR expression, immunohistochemical (IHC) analysis on archival tumor tissue was performed. We performed standard IHC and applied combined intensity score (from 0 to 3) for antigen expression and proportional score of 0-3 for the cells that were positive. For antigen expression, 0 was no staining, +1 being 1-25% staining, +2 being 26-50% staining and +3 being 50% or greater staining. Number of patients with PDGFR alpha and PDGFR beta expression was correlated with time patients were on treatment in days."|Tissue collected during screening process, prior to first treatment and response measured until 350 days.|3 patients were not evaluable due to withdrawal tivozanib within the first 14 days of treatment. Not all patients treated on study provided tissue or had sufficient tissue to be analyzed for PDGFR expression. No patients showed PDGFR alpha +1 or +3 expression.|||participants|||Number
2637452|NCT01782313|Post-Hoc|Number of Patients With 0-3 VEGFR3 Protein Expression and Time in Days on Treatment|"Tissue from biopsy will be collected during screening and proteins (VEGFR3) will be evaluated to see if there is a correlation with patient response to treatment.~VERGFR = vascular endothelial growth factor receptor~To determine if there was a correlation between response to Tivozanib and VEGFR expression, immunohistochemical (IHC) analysis on archival tumor tissue was performed. We performed standard IHC and applied combined intensity score (from 0 to 3) for antigen expression and proportional score of 0-3 for the cells that were positive. For antigen expression, 0 was no staining, +1 being 1-25% staining, +2 being 26-50% staining and +3 being 50% or greater staining. Number of patients with VEGFR1 expression was correlated with time patients were on treatment in days."|Tissue collected during screening process, prior to first treatment and response measured until 350 days.|3 patients were not evaluable due to withdrawal tivozanib within the first 14 days of treatment. Not all patients treated on study provided tissue or had sufficient tissue to be analyzed for VEGFR expression.|||participants|||Number
2637453|NCT01782313|Secondary|Treatment Toxicity as Measured by Adverse Events Experienced While on Treatment During Systematic Assessment.|"Toxicity will be assessed after 4 weeks (1 cycle) and every 4 weeks during treatment according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 4.0 (CTCAE v4.0). In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|After every 4 weeks (1 cycle) until treatment discontinuation and up to a maximum of 2 years and 10 months.|All patients were considered to be evaluable for adverse events. Frequency of treatment related adverse events equal to or more than 10% graded to be either 1 (mild), 2 (moderate),3 (severe), 4 (life-threatening).|||participants|||Number
2637454|NCT01782313|Secondary|Number of Patients With 0-3 VEGFR1 and VEGFR2 Protein Expression and Time in Days on Treatment|"Tissue from biopsy will be collected during screening and proteins (VEGFR1 and VEGFR2) will be evaluated to see if there is a correlation with patient response to treatment.~VERGFR = vascular endothelial growth factor receptor~To determine if there was a correlation between response to Tivozanib and VEGFR expression, immunohistochemical (IHC) analysis on archival tumor tissue was performed. We performed standard IHC and applied combined intensity score (from 0 to 3) for antigen expression and proportional score of 0-3 for the cells that were positive. For antigen expression, 0 was no staining, +1 being 1-25% staining, +2 being 26-50% staining and +3 being 50% or greater staining. Number of patients with VEGFR1 expression was correlated with time patients were on treatment in days."|Tissue collected during screening process, prior to first treatment and response measured until 350 days.|3 patients were not evaluable due to withdrawal tivozanib within the first 14 days of treatment. Not all patients treated on study provided tissue or had sufficient tissue to be analyzed for VEGFR expression.|||participants|||Number
2641797|NCT01741688|Primary|Number of Participants on Tocilizumab at 6 Months After Treatment Initiation||At 6 months||||participants|||Number
2637455|NCT01782313|Secondary|Overall Survival up to 2 Years Beyond Progression|Patients will be followed-up with from first dose of study drug up to 2 years following the date of disease progression.|Time from the first dose of study treatment up to 2 years beyond disease progression|3 patients were not evaluable due to withdrawal tivozanib within the first 14 days of treatment.|||Months||95% Confidence Interval|Median
2637456|NCT01782313|Secondary|Clinical Benefit Rate as Defined by Complete Response, Partial Response and Stable Disease.|"The clinical benefit of study treatment will be assessed after 8 weeks (2 cycles) of therapy using scanning images (CT or MRI). Clinical benefit rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI:~Complete Response (CR) = disappearance of all target lesions. Partial Response (PR), = at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.~Progressive Disease (PD) = At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.~Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started."|Every 2 cycles (8 weeks) up to 2 years|3 patients were not evaluable due to withdrawal tivozanib within the first 14 days of treatment.|||Participants|||Count of Participants
2637457|NCT01782313|Secondary|Overall Response Rate Defined as Complete Response and Partial Response.|"The response to study treatment will be assessed after every 8 weeks (2 cycles) of therapy using CT or MRI scan images.Overall response rate will be measured per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI:~Complete response (CR) = disappearance of all target lesions. Partial Response (PR), = at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD."|Every 2 cycles (8 weeks) up to 2 years|3 patients were not evaluable due to withdrawal tivozanib within the first 14 days of treatment.|||Participants|||Count of Participants
2637458|NCT01782313|Primary|Percentage of Patients With Progression-free Survival at 16 Weeks.|"Progression-free survival from study disease will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) Committee, version 1.1 assessed using imaging scans (CT or MRI) and clinical assessment following 16 weeks of treatment.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as accurate and appropriate."|At 16 weeks of treatment.|3 patients were not evaluable due to withdrawal tivozanib within the first 14 days of treatment.|||Percentage of patients||95% Confidence Interval|Number
2637459|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Score of the Clinical Global Impression Scale (CGI) Item I (Severity of Illness)|"The Clinical Global Impression (CGI) scales (Guy and Bonato, 1970) were initially developed for a risk-benefit estimation within the treatment of mentally ill patients. The 4 global scales (severity of illness, change in severity from Baseline, therapeutic efficacy, and tolerability of treatment) are used as different measures of treatment outcome in different kinds of pharmacological studies.~The CGI Item 1 (severity of illness) collected 1 answer out of 8 categories (0-'Not assessed', 1-'Normal, not at all ill', 2-'Borderline ill', 3-'Mildly ill', 4-'Moderately ill', 5-'Markedly ill', 6-'Severely ill', and 7-'Among the most extremely ill patients') at each assessment. The category 0-'Not assessed' was considered as missing and therefore used neither for calculation nor for display purposes."|Baseline (Visit 2) until End of the Maintenance Period/Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.|||participants|||Number
2637460|NCT01782222|Secondary|"Change From Baseline to the End of the Maintenance Period in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Subscale) in on State"|"Part III of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit.~The UPDRS Part III (motor subscale) had to be measured in the on state and consisted of 27 items and sub items scored between 0 and 4. The sum score ranged between 0 and 108 and was calculated as sum of the 27 individual scores. If 1 or more items were missing and could not be substituted with a previous post-Baseline value, the sum score was also missing.~A negative value indicates an improvement."|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.|||scores on a scale||Standard Deviation|Mean
2637461|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the Beck Depression Inventory Second Edition (BDI-II)|The Beck Depression Inventory (BDI) is a self-report instrument to measure depression symptoms and severity (Beck et al, 1961). The BDI-II is a revised version of the scale in order to be more consistent with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for depression (Beck et al, 1996). There are 21 items in the BDI-II, classified as cognitive-affective (Items 1-13) and somatic-performance (Items 14-21) subscales. The degree of severity is indicated on a 4-point scale; items are rated from 0 (not at all) to 3 (extreme form of each symptom). Scores of 0-13 indicate minimal depression, 14-19 indicate mild depression, 20-28 indicate moderate depression, and 29-63 indicate severe depression.|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.|||scores on a scale||Standard Deviation|Mean
2637468|NCT01781975|Secondary|Number of Adverse Events|Number of adverse events that were reported throughout the study.|Adverse Events will be assessed at Visit 0 (week 0), Visit 1 (Week 2), Visit 2 (Week 4), and every month thereafter.||||events|||Number
2637462|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the Snaith Hamilton Pleasure Scale (SHAPS)|The Snaith Hamilton Pleasure Scale (SHAPS) (Snaith et al, 1995) is a self-report instrument developed for the assessment of hedonic capacity. The sum of the 14 items scores range from 0 to 14. A higher score represents more anhedonic symptoms.|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.|||scores on a scale||Standard Deviation|Mean
2637463|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the Mood / Cognition Domain of the Nonmotor Symptom Assessment Scale (NMSS)|"Nonmotor performance was assessed via the Nonmotor Symptom Assessment Scale (NMSS), an accepted scale that has been validated in an international study (Naidu et al, 2006; Chaudhuri et al, 2007), at the Baseline Visit as well as at the end of the Maintenance Period. The severity and frequency of the subject's nonmotor symptoms were assessed by the investigator (or designee) in the following 9 domain categories: cardiovascular, including falls; sleep/fatigue; mood/cognition; perceptual problems/hallucinations; attention/memory; gastrointestinal tract; urinary; sexual function; and miscellaneous.~Items are scored for severity (from 0 (none) to 3 (severe)) and frequency (from 1 (rarely) to 4 (very frequent )). The score was calculated as severity x frequency. The theoretical minimum is 0 (best possible outcome) and maximum total score is 360 points (worst possible outcome)."|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.|||scores on a scale||Standard Deviation|Mean
2637464|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-item Parkinson's Disease Questionnaire (PDQ-8)|The 8-Item Parkinson's Disease Questionnaire (PDQ-8) (Peto et al, 1998) is a self-administered questionnaire that provides a reliable measure of overall health status. The PDQ-8 collects 8 items with 5 categories each (0=never, 1=occasionally, 2=sometimes, 3=often, 4=always or cannot do at all). The total score was calculated by summing the scores of all applicable questions and convert the resulting sum to a summary index score between 0 and 100 by multiplying with 100/32. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.|||scores on a scale||Standard Deviation|Mean
2637465|NCT01782222|Secondary|Change From Baseline to the End of the Maintenance Period in the Score of the Apathy Evaluation Scale (AS) Rated by the Caregiver (Where Available)|"The Apathy Scale (AS) is an abbreviated version of the Apathy Evaluation Scale. The AS (Starkstein et al, 1992) consists of 14 items phrased as questions by the examiner that are to be answered on a 4-point Likert scale. It was developed specifically for subjects with Parkinson's disease because the Apathy Evaluation Scale was considered too demanding.~The questions comprising the AS were answered by the caregiver. The questions were asked in a structured interview format. The caregiver was interviewed by appropriate medical staff and asked questions about the subject in the third person.The total scores for Apathy Evaluation Scale ranges from 0 (best possible outcome) to 42 (worst possible outcome)."|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.|||scores on a scale||Standard Deviation|Mean
2637466|NCT01782222|Primary|Change From Baseline to the End of the Maintenance Period in the Total Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living) + III (Motor Symptoms)|Part II of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses the subject's activities of daily living. Part III assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit. Part II is subject-rated and Part III is physician-rated. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score was calculated as the sum of these 13 individual scores. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score was calculated as sum of these 27 individual scores. The sum score of UPDRS Parts II and III is the sum of the corresponding single sum scores. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.|||scores on a scale||Standard Deviation|Mean
2637467|NCT01782222|Primary|Change From Baseline to the End of the Maintenance Period in the Score of the Apathy Evaluation Scale (AS) Rated by the Patient|"The Apathy Scale (AS) is an abbreviated version of the Apathy Evaluation Scale. The AS (Starkstein et al, 1992) consists of 14 items phrased as questions by the examiner that are to be answered on a 4-point Likert scale. It was developed specifically for subjects with Parkinson's disease because the Apathy Evaluation Scale was considered too demanding.~The questions comprising the AS were answered by the subject. The total scores for Apathy Evaluation Scale ranges from 0 (best possible outcome) to 42 (worst possible outcome)."|Baseline (Visit 2) until End of the Maintenance Period / Early Withdrawal (up to 19 weeks after Baseline)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS included all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement for both primary efficacy variables.|||scores on a scale||Standard Deviation|Mean
2637472|NCT01781975|Secondary|Area Under the Stimulated C-peptide Curve (AUC) Mean Over 4 Hours at 24 Months|Area under the MMTT-stimulated peak, 4 hour C-peptide AUC mean at week 104. The units are reported as nano-moles/Liter because this is AUC mean (the AUC is divided by the time internal so that the units return to the c-peptide units of measure).|Visit 13 (Week 104)||||nmol/L||95% Confidence Interval|Mean
2637473|NCT01781975|Primary|Area Under the Stimulated C-peptide Curve (AUC) Mean Over the First 2 Hours of a 4 Hour Mixed Meal Tolerance Test at the 1 Year Visit|"The primary outcome of each participant is the area under the stimulated c-peptide curve (AUC) mean based on data collected at time 0 to 2 hours of a 4-hour mixed meal tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30, 60, 90, and 120 minutes. The term AUC mean comes from the mean value theorem in calculus. It is the value on the scale of the y-axis that is equal to the AUC divided by the range on the x-axis (in this case 120 minutes)."|Visit 9 (Week 52) at 0, 15, 30, 60, 90, 120 minutes post-dose||||nmol/L||Standard Deviation|Mean
2637474|NCT01781962|Secondary|Number of Study Eyes in Each Step Grade Using Gonioscopic Lens|The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Large Step Grading ranging from 1.0 (smallest angle width) to 7.5 (largest angle width) with 0.5 unit intervals where each Large Step unit represented a fixed length of approximately 200 µm. The number of eyes in each Large Step Grade is reported.|Day 1|Participants from the mITT population, all enrolled patients with both gonioscopy and AS OCT measurements, with data available for this outcome measure.|||eye|Participants||Number
2637475|NCT01781962|Secondary|Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens|The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Shaffer grading where: grade 4=wide open, grade 3=moderately open, grade 2=moderately narrow, grade 1=very narrow or grade 0=closed. The number of eyes in each Shaffer Grade is reported.|Day 1|Participants from the mITT population, all enrolled patients with both gonioscopy and AS OCT measurements, with data available for this outcome measure.|||eye|Participants||Number
2637476|NCT01781962|Primary|Anterior Angle Width Using Anterior Segment Optical Coherence Tomography (AS OCT)|The angle width formed between the eye's cornea and iris in both eyes was measured in microns (µm) using AS OCT, a laser-based, noninvasive, diagnostic system providing high-resolution images of the eye.|Day 1|Participants from the Modified Intent-to-treat (mITT) population, all enrolled patients with both gonioscopy and AS OCT measurements, with evaluable data for this outcome measure.|||µm|Participants|Standard Deviation|Mean
2637477|NCT01781832|Primary|Shear Wave Velocity (VITQ)|Shear Wave Velocity, VITQ, or Virtual Touch Tissue Imaging quantification is a color 2D method for measuring a tissues's stiffness. A color image (elastogram) of stiffness is acquired using this method. Then, one or more regions of interest can be placed in the area of interest on the elastogram. VITQ regions of interest are smaller than those used by VTQ.|Visit 0|The subjects were pediatric patients already scheduled to have cystometrogram (CMG) testing for bladder abnormalities. CMG involves inserting a catheter into the bladder. The ultrasound scans may be an alternative way to determine bladder abnormalities. Ultrasound scanning is a non-invasive and painless procedure.|||meters per second||Standard Deviation|Mean
2637478|NCT01781832|Primary|Shear Wave Velocity, VTQ|"Shear wave velocity VTQ, or Virtual Touch Quantification is a point method for measuring a tissue's stiffness. A stiffness value is obtained from only the area in which a region of interest is placed."|Visit 0|"The subjects were pediatric patients already scheduled to have cystometrogram (CMG) testing for bladder abnormalities. CMG involves inserting a catheter into the urinary bladder.~The ultrasound scans were investigated as an alternative way to determine bladder abnormalities. Ultrasound scanning is a non-invasive and painless procedure."|||meters per second||Standard Deviation|Mean
2637479|NCT01781806|Other Pre-specified|Number of HIV Seroconversions by Cohort.||Baseline to 48 weeks||||Participants|||Count of Participants
2637480|NCT01781806|Other Pre-specified|Escalation in Transmission Risk Behavior Among Participants Reporting Low Risk Behaviors at Baseline|Changes in sexual risk behavior as assessed via CASI-based self-report questionnaire, measured longitudinally over time.|Baseline to 48 weeks||||Participants|||Count of Participants
2637481|NCT01781806|Secondary|Cohort H PrEP Engagement by Study Visit|Optimal adherence to daily oral emtricitabine/tenofovir disoproxil fumarate by study visit as measured by tenofovir diphosphate (TFV-DP) in dried blood spots (DBS). Optimal adherence is defined as TFV-DP levels great than or equal to 700 femtomoles per punch in DBS samples (approximately 4 or more doses a week over the past 60 days).|Baseline to 48 weeks||||Participants|||Count of Participants
2637482|NCT01781806|Primary|Number of Participants With a Grade 2 or Higher Adverse Event by Cohort|Number and frequency rate of clinical and laboratory AEs (Gr 2 and above), including SAEs by Cohort.|Baseline to 48 weeks||||Participants|||Count of Participants
2637483|NCT01781637|Secondary|Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo||12 weeks after last dose of omalizumab/placebo||||Participants|||Count of Participants
2637484|NCT01781637|Primary|Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo||6 weeks after last dose of omalizumab/placebo||||Participants|||Count of Participants
2637485|NCT01781481|Primary|Number of Inpatient Hospital Admissions|Total number of times that the patient was admitted to hospital during the 3-month period prior to the Pediatric INTERMED Interview.|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)||||Number of hospital admissions||Full Range|Median
2637486|NCT01781481|Primary|Number of Visits to the Hospital Emergency Department|Number of times that the patient visited the hospital Emergency Department in the 3-month period prior to the Pediatric INTERMED interview.|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)||||Emergency Department Visits||Full Range|Median
2637487|NCT01781481|Primary|Number of Extra Appointments With the IBD Team|Number of extra appointments (unscheduled, emergency) with the IBD Team during the 3 month period prior to the Pediatric INTERMED interview.|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)||||Number of appointments||Full Range|Median
2637596|NCT01780545|Secondary|Overall Survival (OS) According to Baseline Serum Hsp27 Level.|A subgroup analysis to determine the median overall survival time based on baseline Hsp27 levels.|36 months|Subjects with a baseline Hsp27 level were included in this subgroup analysis|||months||95% Confidence Interval|Median
2637488|NCT01781481|Primary|Number of Calls to IBD Nurse|Total number of calls made by patient or parent to the IBD clinic nurse during the 3-month period prior to the Pediatric Intermed Interview|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)||||Number of calls||Full Range|Median
2637489|NCT01781481|Primary|Total Number of Hospital Services Involved in Child's Care.|Measure of number of hospital services involved in each child's care during the three month period prior to the Pediatric INTERMED interview.|Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)||||R Square change statistic||Full Range|Median
2637490|NCT01781481|Primary|Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators|Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domain scores and items. Refer to Outcome Measure 6 for information pertaining to Disease/Treatment Indicators. Refer to Outcome Measure 23 for information about the Number of Services involved in Child's Care, and to Outcome Measure 15 for information about the Family Inventory of Resources for Management.|Pediatric INTERMED and FIRM scores obtained at Study Entry and Disease and Health Care Indicators since IBD Diagnosis||||Correlation Coefficients|||Number
2637491|NCT01781481|Primary|Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Externalizing Score is in the Clinical Range.|This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Externalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Externalizing Scale were categorized as falling into the clinical range.|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for the CBCL measure, due to fewer participants completing this questionnaire.|||participants|||Number
2637492|NCT01781481|Primary|Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Internalizing Score Falls in the Clinical Range.|This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Internalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Internalizing Scale were categorized as falling into the clinical range.|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for the CBCL measure, due to fewer participants completing this questionnaire.|||participants|||Number
2637493|NCT01781481|Primary|Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total Children's Depression Inventory (CDI) Score is in the Clinical Range.|This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Children's Depression Inventory. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 11 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Children's Depression Inventory were categorized as falling into the clinical range.|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for the CDI measure, due to fewer participants completing this questionnaire.|||participants|||Number
2637494|NCT01781481|Primary|Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total MASC Score Falls in the Clinical Range.|This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat item when they scored in the clinical range on the Multidimensional Anxiety Scale for Children. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 12 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Multidimensional Anxiety Scale for Children were categorized as falling into the clinical range.|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for the MASC measure, due to fewer participants completing this questionnaire.|||participants|||Number
2637495|NCT01781481|Primary|Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning.|Relations between Pediatric INTERMED Psychological, Social and Family Domain scores and other validated measures of subjects' psychosocial adjustment, including depression (Children's Depression Inventory- Outcome Measure 11), anxiety (Multidimensional Anxiety Scale for Children-Outcome Measure 12), Behavioural Adjustment (Internalizing and Externalizing Scores on the CBCL- Outcome Measure 10), Competence (Social, Activities and School Competence Scores from the CBCL- Outcome Measure 10), and family functioning (Parenting Inventory for Parents- Outcome Measure 13, Family Inventory of Life Events-Outcome Measure 14, Family Inventory of Resources for Management- Outcome Measure 15), and IBD health-related quality of life (IMPACT III: Emotional Functioning and Social Interactions scales- Outcome Measure 9).|Day 1 (Time of Study Participation)||||Pearson Correlation Coefficient|||Number
2637597|NCT01780545|Secondary|Overall Response Rate|To compare overall response rate (ORR) between the treatment arms.|Every 6 weeks|Data for this secondary outcome measure was not collected nor analyzed.||||||
2637496|NCT01781481|Primary|Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning|Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domains and items. Refer to Outcome Measure 4 for information pertaining to IBD Disease Severity. Refer to Outcome Measure 5 for information pertaining to Disease Treatments. Refer to Outcome Measure 8 for information pertaining to Functioning Disability Inventory. Refer to Outcome Measure 9 for information pertaining to the IMPACT III- Quality of Life Questionnaire.|Pediatric INTERMED and Functioning at study participation and Disease related indices since IBD Diagnosis||||Correlation Coefficients|||Number
2637497|NCT01781481|Primary|Family Inventory of Resources for Management|Family Inventory of Resources for Management (FIRM): (McCubbin & Comeau 1991). The FIRM was developed to assess the family's repertoire of resources. The scale is comprised of 69 items, which are responded to using a 4-point Likert scale format (0-3). The scale has been found to have good internal reliability (r=.89, Cronbach's alpha), content and concurrent validity when used in normative sample of families with chronically ill children. The possible range for the total score is from 0-207, with higher scores indicating greater family resources for management. The Financial Well-Being subscale consists of 16 items, with potential scores ranging from 0-48, with higher scores indicating greater family financial resources.|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.|||units on a scale||Inter-Quartile Range|Median
2637498|NCT01781481|Primary|Family Inventory of Life Events and Changes|Family Inventory of Life Events and Changes (FILE): (McCubbin & Patterson, 1991). The FILE is a 71-item, yes/no instrument that assesses chronic and recent life stress in nine areas: intra-family strains, marital strains, pregnancy and childbearing strains, finance and business strains, work-family transitions and strains, illness and family care strains, losses, transition in and out, and family and legal violations. Family members indicate whether particular stressful events have occurred. The FILE has been found to have high reliability (Cronbach's alpha=.72), good test-retest reliability, internal consistency and evidence of construct validity. Scores can range from 0-71, with higher scores indicating greater family stress.|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.|||units on a scale||Inter-Quartile Range|Median
2637499|NCT01781481|Primary|Pediatric Inventory for Parents- Difficulty Score|"Pediatric Inventory for parents: (PIP; Streisand et al., 2001). The PIP is a 42-item self-report measure of parenting stress associated with caring for a medically ill child. It is the only published measure of parenting stress the specifically taps the experiences and stresses that parents face when caring for a medically ill child. The Difficulty Score - indicates parents' perception of the perceived difficulty of each stressor/item. Each item is scored on a 5 point Likert scale, with total scores ranging from 42 to 210, with higher scores indicating greater perceived difficulty."|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this outcome measure, as a result of a few parents not having completed this questionnaire.|||units on a scale||Inter-Quartile Range|Median
2637500|NCT01781481|Primary|Multidimensional Anxiety Scale for Children|"Multidimensional Anxiety Scale for Children: (MASC; March et a., 1997). The MASC is a pediatric self-report scale that measures symptoms of anxiety. It consists of 39 items assessing physical symptoms of anxiety, harm avoidance, social anxiety and separation/panic. Each item is answered using a four point Likert scale ranging from (0) never true about me to (3) often true about me. Total scores can range from 0 to 117. The raw total score was scaled to T-Scores to control for age and sex differences."|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this outcome measure, as a result of a few participants not having completed this questionnaire.|||units on a scale- T scores||Inter-Quartile Range|Median
2637501|NCT01781481|Primary|Children's Depression Inventory|27 item self-report questionnaire used to measure depressive symptoms in children and youth (Kovacs 1992). Each item is rated on a 3-point Likert scale (0-2) with a minimum score of 0 and a maximum score of 54, with higher scores indicating more depressive symptoms. Raw scores were scaled to T-scores to control for age and gender differences.|Administered at study entry|The number of participants was lower due to some missing data for this outcome measure, as a result of a few participants not having completed this questionnaire.|||Units on a Scale - T Scores||Inter-Quartile Range|Median
2637502|NCT01781481|Primary|Child Behaviour Checklist|Child Behaviour Checklist: (CBCL: Achenbach 1991). The CBCL is used to evaluate behaviour problems and social competencies of children 6 to 18 years old. The measure is completed by parents or parent surrogates who base their ratings on the preceding 6 months. It is comprised of 120 problem items that factor into eight syndrome scales, which can be grouped into Internalizing, Externalizing and Total Problem Scales. Higher scores indicate greater level of emotional/behavioural difficulties. In the present study we utilized the following CBCL subscale scores: Internalizing, Externalizing, Social Competence, Activities Competence, Academic Competence. All scores reported are scaled to T Scores.|Day 1 (Date of patient's participation in the Pediatric Intermed interview).|The number of participants was lower due to some missing data for this indicator, as a result of a few parents not having completed this questionnaire.|||Units on a Scale - T Scores||Inter-Quartile Range|Median
2637503|NCT01781481|Primary|Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease.|35-item self report measure for assessing quality of life in children with IBD (Otley, Griffiths, Hale et al., 2006). Items are rated on a 5-point Likert scale, with lower scores indicating poorer health related quality of life. Scores can range from 35-175. Four factor scores can be calculated: General Well-Being, Emotional Functioning, Social Functioning, Body Image, as well as a Total Quality of Life Score (Perrin, Kuhlthau, Chughtai et al., 2008).|Day 1 (At time of Pediatric Intermed Interview)|The number of participants was lower due to some missing data for this indicator, due to a few participants not completing this questionnaire.|||units on a scale||Inter-Quartile Range|Median
2637581|NCT01780662|Secondary|Correlation Between Micro Ribonucleic Acid (miRNA) and Disease Response to Protocol Treatment|Limit to 41 evaluable patients who received dose 1.8 mg/kg|From the end of first dose to the end of last dose (Up to 13 Months)|These samples were banked but not analyzed, due to a change in research priorities.||||||
2637504|NCT01781481|Primary|Functional Disability Inventory|"Functional Disability Inventory: (FDI); Walker & Greene, 1991). The FDI assesses illness related activity limitations in children and adolescents. The measure consists of 15 items that are scored by the child and parent as (0) no trouble to (4) impossible. The minimum score is 0 and the maximum score is 60, with higher scores indicating greater functional disability. The FDI has demonstrated good psychometric properties with test-retest reliability of .92 and .85 at the 3-month follow-up. Concurrent validity was provided by correlation (r=.52, p<.001) between the FDI and an objective index of disability (Walker & Greene, 1991)."|Day 1 (Date of patient's participation in the Pediatric Intermed interview).||||units on a scale||Full Range|Median
2637505|NCT01781481|Primary|IBD Treatment With Immunomodulators or Anti-TNFa Medications|"Use of Immunomodulators (azathioprine or methotrexate). Coded for each participant as yes (Score of 1) or no (Score of 2). Use of anti-Tumor Necrosis Factor alpha (TNFa) medications (infliximab or adalimumab). Coded for each participant as yes (Score of 1) or no (Score of 2)."|Information from review of participants chart from time of diagnosis until study participation (date of Pediatric INTERMED interview).||||Percentage of participants treated|||Number
2637506|NCT01781481|Primary|Disease Course and Treatment|Number of hospitalizations since diagnosis (total number recorded in health record), number of surgeries since diagnosis (total number recorded in health record), number of courses of Prednisone (total number recorded in health record).|Data collected through chart review with respect to the period since diagnosis and Day 1 (date that patient's participation in Pediatric Intermed interview)||||number of times it occurred||Full Range|Median
2637507|NCT01781481|Primary|Time Since IBD Diagnosis|"Time since subject's initial IBD diagnosis. Data for each subject was obtained from chart review and was coded in months since date of diagnosis, with a range from 1 - 131 months."|Data collected through chart review at time of Pediatric INTERMED interview.||||Percentage of Participants|||Number
2637508|NCT01781481|Primary|IBD Disease Severity|IBD Disease Severity Index categorizes patient's level of disease severity based on patient scores on the Pediatric Crohn's Disease Activity Index (PCDAI): (Hymans, Markowitz, Otley et al., 2005) and the Pediatric Ulcerative Colitis Activity Index (PUCAI) (Turner, Otley, Mack et al., 2007). Children's scores on either of these indices are used to categorize the severity of their disease as: inactive, mild, moderate, or severe.|Day 1 (Date of patient's participation in the Pediatric Intermed interview).||||percentage of participants|||Number
2637509|NCT01781481|Primary|Pediatric INTERMED Items|Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items.|Day 1 (At time of Pediatric Intermed Interview)||||Percentage of participants|||Number
2637510|NCT01781481|Primary|Correlations Between Pediatric INTERMED Domain Scores|Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED domain scores.|Pediatric INTERMED scores at time of study participation||||Correlation Coefficient|||Number
2637511|NCT01781481|Primary|Pediatric INTERMED- Complexity Index|"34 item screening tool which identifies biological, psychological, social, caregiver/family and health service needs that contribute to case complexity. Each item is rated on a scale from 0-3 (0= no need to act; 1= watchful waiting or preventive intervention, 2=need for action, 3=need for immediate action).~Minimum total score is 0 and Maximum score would be 102 (high complexity). Items on the Pediatric INTERMED are organized into 5 domains:~Biological Domain (6 items). Minimum score is 0 and maximum score is 18 (high biological complexity).~Psychological Domain (9 items). Minimum score is 0 and maximum score is 27 (high psychological complexity).~Social Domain (7 items). Minimum score is 0 and maximum score is 21 (high social complexity).~Family/Caregiver Domain (7 items). Minimum score is 0 and maximum score is 21 (high family/caregiver complexity).~Health Services Domain (5 items). Minimum score is 0 and maximum score is 15 (high health service complexity)."|Time of Study Participation (Completion of Pediatric INTERMED tool)||||scores on a scale||Inter-Quartile Range|Median
2637512|NCT01781429|Other Pre-specified|Pharmacodynamic (PD) Response Measured as Percentage Enzyme Inhibition of RSK1 Ser 380 (pRSK)|RSK1, a member of the RSK serine/threonine kinase family, is a direct substrate of the MAP Kinases ERK1 & ERK2. RSK1 and ERK1/2 form an inactive complex in unstimulated cells. Upon activation of the mitogenic pathway, ERK1/2 phosphorylates Thr573, Thr359 and Ser363 on RSK1. Thr573 resides in the activation loop of the carboxy terminal kinase domain of RSK1 and once phosphorylated, enables RSK1 to autophosphorylate Ser380. Phosphorylation of Ser380 on RSK1 can therefore be used as a target biomarker for ERK1 and ERK2 activity. BVD-523 inhibits the activity of ERK. In this study, phosphorylation of RSK1 Ser 380 (pRSK) was used as a target biomarker for assessment of ERK inhibition by BVD-523 in human whole blood samples.|Patients will be evaluated at baseline and on ~day 15 of Cycle 1|The protocol was amended to stop collecting PD samples unless the patient consented to a tumor biopsy. Therefore, some patients did not have PD samples collected or did not consent to optional research tests involving collection of tumor tissue and blood/plasma samples.|||Enzyme inhibition (%)||Standard Deviation|Mean
2637513|NCT01781429|Secondary|Clinical Evidence of Tumor Response Assessed by Physical or Radiological Exam.|At enrollment, all study patients had metastatic or advanced-stage malignant tumor for which no curative therapy was known to exist. Patients entering Part 2 additionally had to have measurable disease by RECIST version 1.1. Data shown is best response.|Patients will be evaluated at baseline & at periodic follow-up visits through the time their participation in the study is completion. The best responses presented occurred at different time points for each patient.||||Participants|||Count of Participants
2637514|NCT01781429|Secondary|Characterization of the Time Versus Plasma Concentration Profiles of BVD-523 and Selected Metabolites.|Data provided is for BVD-523.|Samples will be collected on day 1 and day 15 of Cycle 1|Day 1 - Dose-escalation 10mg b.i.d. patient was not calculable. Cohort-expansion numbers do not include those patients that were dose reduced and/or were not at a steady state with 600mg b.i.d. for the Day 15 draw.|||ng/mL||Standard Deviation|Mean
2637527|NCT01781286|Secondary|Snack Palatability and Perception Questionnaires|"Computerized questionnaires, assessing snack palatability and perceptions of the snack will be completed during screening and after the first and last bite of each snack during the acclimation and testing days. The questionnaires contain visual analog scales incorporating a 100 mm horizontal line rating scale for each response. The questions are worded as how strong is your feeling of with anchors of not all (scores 0 out of 100) to extremely (scores 100 out of 100). The questions assess snack appearance, smell, flavor, texture (feel), liking.~The Adaptive Visual Analog Scale Software (Neurobehavioral Research Laboratory and Clinic; San Antonio, TX) was used for these assessments."|5 min||||millimeters||Standard Error|Mean
2637515|NCT01781429|Primary|Determination of Recommended Phase 2 Dose (RP2D) of BVD-523 by Dose-limiting Toxicities (DLT).|"DLT is defined as any BVD-523 related toxicity in the first 21 days of treatment that results in:~≥Grade 4 hematologic toxicity for >1 day;~Grade 3 hematologic toxicity with complications e.g., thrombocytopenia with bleeding;~≥Grade 3 non-hematologic toxicity, except untreated nausea, vomiting, constipation, pain and rash (these become DLTs if the adverse event (AE) persists despite adequate treatment), a doubling of aspartate transaminase (AST)/alanine transaminase (ALT) in patients with grade 2 ALT/AST at baseline;~A treatment interruption exceeding 5 days (or an interruption exceeding 7 days for rash, despite adequate treatment) in Cycle 1 (or inability to begin Cycle 2 for > 7 days) due to BVD-523-related toxicity."|As indicated by safety and tolerability during study conduct; ~42 months||||Participants|||Count of Participants
2637516|NCT01781403|Other Pre-specified|Disease-free Survival||3-year or 5-year after surgery|||||||
2637517|NCT01781403|Other Pre-specified|Efficacy|"Efficacy: Pathologic major responses = total regression + near total regression.~We will carefully inspect the circumferential resection margin, defining a positive margin as any residual tumor within ≤ 1 mm of the circumferential margin.~Pathologic responses and stages will be classified according to Dworak's classification1 and the AJCC (American Joint Committee on Cancer) staging system, respectively. In each case, the entire tumor including mesorectal fat will be serially sliced into 4-mm-thick sections and embedded in paraffin.~A pathologic complete response is defined as grade 4 tumor regression; with residual fibrotic mass or acellular mucin pools only, thus without detectable tumor cells~A near total response is defined as grade 3 tumor regression; with very few tumor cells in fibrotic tissue with or without mucous substance."|after surgery (6-8 weeks after study treatment)|||||||
2637518|NCT01781403|Other Pre-specified|Toxicity|"Toxicity will be monitored and recorded every week during study treatment (5 or 6 weeks) as following according to the NCI-CTCAE version 4.0~An interval history and physical examination with particular attention to drug-induced side effects along with documentation of the patient's weight and performance status will be performed on each visit.~CBC with differential count, blood chemistry including calcium, phosphorus, glucose, BUN, creatinine, total protein, albumin, AST, ALT, alkaline phosphatase, total bilirubin, and electrolyte will be performed before next planned treatment.~All relevant information regarding drug dosage, laboratory examinations, and treatment-related toxicities must be recorded before each treatment is given.~Summaries of the frequency and severity of adverse effects are based on the worst episodes recorded."|5-6 weeks during study treatment||||events|||Number
2637519|NCT01781403|Secondary|Pathological Complete Response|"Pathologic responses and stages were classified according to Dworak's classification and the 7th edition of the American Joint Committee on Cancer staging system, respectively.~The pathologic complete response (pCR) was defined as the total regression of the primary tumor regardless of regional lymph nodal status (ypT0), with residual fibrotic mass or acellular mucin pools only, thus without detectable tumor cells."|at the time of surgery (6-8 weeks after study treatment)||||participants|||Number
2637520|NCT01781403|Primary|Recommended Dose (RD)|RD will be defined as one level below the MTD.|5-6 weeks after CRT||||mg/m^2|||Number
2637521|NCT01781403|Primary|Maximum Tolerated Dose (MTD)|The MTD is defined as the maximum dose level in the doses of temozolomide tested with capecitabine and radiation in which the incidence proportion of DLT exceeds 30%.|5-6 weeks during study treatment||||mg/m^2|||Number
2637522|NCT01781299|Secondary|Aesthetic Evaluation|Initial aesthetic evaluation will occur at approximately 6 weeks after permanent implant placement. Re-evaluation will occur at 1 and 3 years following permanent implant placement. This will involve physical examination, 2D photographs, and patient Breast-Q self-examination. Breast-Q examination is on a scale of 25-100 with 25 questions on a scale of 1-4 where 1 is very dissatisfied and 4 is very satisfied.|3 years following permanent implant placement.|discrepancy is caused by funding ending and no data was collected from SurgiMend arm.|||units on a scale||Full Range|Mean
2637523|NCT01781299|Primary|Complication Rates|To determine the complication rate for tissue expander breast reconstruction patients using SurgiMend PRS and AlloDerm RTU ADM products. Time points include: After first procedure: 10-14 days, then 2, 4, 6, and 10 weeks after drain removal; After second procedure: 1-2 weeks, 6 weeks, 1 year, and 3 years.|3 years||||Participants|||Count of Participants
2637524|NCT01781286|Secondary|Energy Intake|"Post-snack energy intake will be assessed through ad libitum dinner and snacking assessments. The ad libitum dinner will contain approximately 2,000 kcal and will consist of a chicken, rice, and stir-fry meal, chips, chocolate mints, ice tea, and water. The dinner meal will be consumed in the testing facility. The participants will be instructed to eat as much as or as little as they choose over a 30 min period. All contents will be weighed before the dinner and any remains will be re-weighed afterwards to determine the type and quantity of foods consumed.~The ad libitum evening snacks will contain 3,000 kcal and will include common snack foods. After the testing day is complete, the participants will take the snack packout home and consume any of the foods he/she chooses until going to bed. All contents will be weighed before the packout and any remains will be re-weighed afterwards to determine the type and quantity of foods consumed."|+300 min, 24 h||||kilojoules||Standard Error|Mean
2637525|NCT01781286|Secondary|Mood-state Questionnaires|Indices of mood state will be assessed immediately before and 60 min post-snack using the on-line, Profile of Mood States, 2nd Edition (POMS2). This program consisted of a core battery of tests with the following sub-categories 1) Tension; 2) Depression; 3) Anger; 4) Vigor; 5) Fatigue; 6) Confusion; and 7) Friendliness. Outcomes are scored as a T-score which could be a minimum of zero with no upper limit. A lower score represents a more positive mood state and a higher score represents a more negative mood state.|-30 min, +60 min||||T-Score||Standard Error|Mean
2637526|NCT01781286|Secondary|Attention & Memory Questionnaires|Cognitive function will be assessed immediately before (-30 min) and 60 min post-snack using the lap-top based Cantab® computerized assessment system. This program consisted of a core battery of tests grouped into main categories including 1) Working Memory; 2) Reasoning; 3) Executive Function; 4) Reaction Time; 5) Sustained Attention; 6) Cognitive Flexibility; and 7) Processing Speed. This program has been used in our previous breakfast studies with success. A greater raw score for working memory, reasoning, executive function, sustained attention, and cognitive flexibility is considered to be greater performance. A lower score for reaction time and processing speed is considered to be greater performance. The raw scores are determined by Cantab® computerized assessment system. Therefore, maximum and minimum values for each test are unknown.|90 min||||Units on a Scale||Standard Error|Mean
2637528|NCT01781286|Secondary|Appetite Questionnaires|"Computerized questionnaires, assessing perceived sensations of appetite will be completed throughout the testing days. The questionnaires contain visual analog scales incorporating a 100 mm horizontal line rating scale for each response. The questions are worded as how strong is your feeling of with anchors of not all (scored as 0 out of 100) to extremely (scored as 100 out of 100). The following questions will be incorporated as 1 composite score ((Questions 1 + 3 + 4 - 2)/4) multiplied by the 300 minutes (a max of 30,000 mm*min and a minimum of -30,000 mm*min):~How strong is your feeling of hunger?~How strong is your feeling of being full?~How strong is your desire to eat?~How much food could you consume right now?~The Adaptive Visual Analog Scale Software (Neurobehavioral Research Laboratory and Clinic; San Antonio, TX) was used for these assessments."|0 min, + 30 min, +60 min, +90 min, +120 min, +150 min, +180 min, +210 min, +240 min, +270 min, +300 min||||mm*min||Standard Error|Mean
2637529|NCT01781286|Primary|Time to Dinner Request|"The participants will be asked whether they would like to request a dinner buffet throughout the 5 h post-snack period. When the response is Yes, I want to eat right now, the time from snack consumption will be recorded."|1 Day||||minutes||Standard Error|Mean
2637530|NCT01781234|Other Pre-specified|Nicotine Craving (Measured by Questionnaire of Smoking Urges)|Questionnaire of Smoking Urges; Total Range= 10-70; Higher values represent worse outcome|90 minutes||||units on a scale||Standard Error|Mean
2637531|NCT01781234|Primary|Salivary Cortisol||90 minutes||||mcg/dL||Standard Error|Mean
2637532|NCT01781234|Primary|Episodic Memory|California Verbal Learning Task Number of Words Learned Higher Values Mean Better Outcome|90 minutes||||number of words recalled||Standard Error|Mean
2637533|NCT01781208|Primary|ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score|"Tissue shear wave speed is positively correlated to a material's/tissue's stiffness and can be noninvasively measured by ultrasound. The relationship between liver shear wave speed and liver histologic fibrosis score were assessed using 2 different ultrasound methods. Liver shear wave speed as obtained using 2 different ultrasound methods served as our primary outcome measures.~Note, the histologic scoring system (Ishak) ranged from 0 to 6, where 0 = no fibrosis and 6 = cirrhosis."|10 minutes|"49 pediatric subjects underwent successful (diagnostic) liver ARFI/VTQ) assessment and liver histologic fibrosis scoring. 13 subjects had non-diagnostic ARFI/VTQ exams.~48 pediatric subjects underwent successful (diagnostic) liver ARFI/VTIQ) assessment and liver histologic fibrosis scoring. 14 subjects had non-diagnostic ARFI/VTIQ exams."|||m/s||Standard Deviation|Mean
2637534|NCT01781169|Primary|Plasma 25-hydroxy Vitamin D (25(OH)D) Level (Nmol/L)||Endpoint and baseline of the 8 weeks' trial||||nmol/L||Standard Deviation|Mean
2637535|NCT01781078|Secondary|Proportion of Participants Without ImageReady System-related Complications|Overall safety of the ImageReady System will be confirmed by evaluating system-related complications that occur from system implant through 3 months post implant for all subjects who underwent an implant procedure and and reached 91 days of follow-up.|3 months post implant||||Percentage of participants||95% Confidence Interval|Number
2637536|NCT01781078|Primary|Success Rate for Sensed Amplitude Measurement at 1 Month Post-MRI Scan or Control Group Visit|The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to Radiofrequency (RF) field-induced heating. Primary Effectiveness Endpoint 2 will evaluate any chronic effects from lead heating that will be seen through decreased sensed amplitude at the MRI Visit + 1 Month follow-up. Data were analyzed separately by chamber, Right Atrium (RA) and Right Ventricle (RV), for this endpoint.|MRI + 1 Month Visit|Right Atrium: a total of 78 Control Group subjects and 135 MRI Group subjects had paired sensed amplitude measurements and met the inclusion criteria. Right Ventricle: a total of 91 Control Group subjects and 152 MRI Group subjects had paired sensed amplitude measurements and met the inclusion criteria.|||% of participants with success|||Number
2637537|NCT01781078|Primary|Success Rate for Threshold Measurement at 1 Month Post-MRI Scan or Control Group Visit|"The MRI scan can result in damage to cardiac tissue surrounding lead electrodes due to RF field-induced heating, which in turn may cause elevated pacing thresholds. Primary Effectiveness Endpoint 1 will evaluate any chronic effects from lead heating that will be seen through increased pacing threshold at the MRI Visit + 1 Month follow-up.~Subjects with an increase in pacing thresholds s 0.5V (at 0.5 ms) from pre-MR Scan/Control Group visit to MRI/Control visit + 1 Month follow-up were considered a success. A success rate was calculated for both the MRI and the Control Groups."|MRI + 1 Month Visit|For the per-protocol analysis, a total of 96 Control Group subjects and 167 MRI Group subjects had paired threshold measurements and met the inclusion criteria.|||% of participants with success|||Number
2637538|NCT01781078|Primary|Proportion of Participants Without MR Scan-related Complications|The primary safety endpoint for SAMURAI will be assessed for all subjects randomized to the MRI Group who undergo any portion of the MRI scan sequences. Safety will be confirmed by evaluating the MRI scan-related Complication-free rate (CFR) between the MR Scan and the MRI Visit + 1 Month Visit.|MRI Visit + 1 Month|The primary safety endpoint for SAMURAI will be assessed for all subjects randomized to the MRI Group who underwent any portion of the MRI scan sequences and did not have a medically necessary scan performed prior to the MRI visit + 1 month follow-up.|||Percentage of participants||95% Confidence Interval|Number
2637539|NCT01781026|Primary|Activity of Vemurafenib in Untreated Brain Metastases|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year|Subjects withdrew prior primary outcome measurement therefore no data was obtained to report||||||
2637540|NCT01780987|Secondary|Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods|All bleeding events consisted of major bleeding (per Interactional Society on Thrombosis and Homeostasis ［ISTH］ Definition), clinically relevant non-major (CRNM) and minor bleeding. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRMN bleeding were classified as minor bleeding.|Baseline to Week 24|The safety analysis set (SAS) consisted of all treated participants.|||participants|||Number
2637565|NCT01780922|Primary|Interleukin-8 (IL-8) Concentrations in Plasma||0, 2, 4, 8, 24 h||||pg/mL||Standard Error|Mean
2637566|NCT01780922|Primary|Interleukin-6 (IL-6) Concentrations in Plasma||0, 2, 4, 8, 24 h||||pg/mL||Standard Error|Mean
2637567|NCT01780922|Primary|Interleukin-4 (IL-4) Concentrations in Plasma||0, 2, 4, 8, 24 h||||pg/mL||Standard Error|Mean
2637541|NCT01780987|Secondary|Number of Participants With Adjudicated Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］During the Treatment Period|Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event.|Baseline to Week 24|The safety analysis set (SAS) consisted of all treated participants.|||participants|||Number
2637542|NCT01780987|Secondary|Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE)|Computed tomography pulmonary angiography (CTPA) was used to assess thrombotic burden in the participants with PE and the results were classified as improved, no change, or worsened. The timings of CTPA examinations were Weeks 2, 12 and 24.|Baseline to Week 24|A subset of full analysis set (FAS) that consisted of participants with PE. n=number of participants evaluated.|||participants|||Number
2637543|NCT01780987|Secondary|Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT)|Computed tomography venography (CTV) and compression ultrasound (CUS) were used to assess thrombotic burden in the participants with DVT and the results were classified as improved, no change, or worsened. The timings of CTV and CUS examinations were at Week 12 and Weeks 2, 12 and 24.|Baseline to Week 24|A subset of full analysis set (FAS) that consisted of participants with DVT. n=number of participants evaluated.|||participants|||Number
2637544|NCT01780987|Secondary|Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) ［Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)］ or VTE-Related Death During the Intended Treatment Period|"VTE-related death was defined as a death caused by documented PE which was diagnosed with objective testing or autopsy, or an unexplained death for which DVT/PE could not be ruled out as the cause. Intended Treatment Period was the period starting on the day of randomization and ending at either 2 days after the last dose of the study drug or Day 168/Week 24, whichever came late."|Baseline to Week 24|Full analysis set (FAS) was defined as all randomized participants. Participants with missing endpoint information were excluded from the analysis.|||participants|||Number
2637545|NCT01780987|Primary|Number of Participants With Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period|Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. CRNM bleeding event was defined as an acute clinically overt bleeding that did not satisfy the definition of major bleeding and that led to either hospitalization, physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.|Baseline to Week 24|The safety analysis set (SAS) consisted of all treated participants.|||participants|||Number
2637546|NCT01780974|Secondary|White Matter Hyperintensity Volume (Brain MRI)||Baseline and 12 months|At baseline, 4 participants either could not complete the MRI or the MRI could not be analyzed due to quality; at 12 months, 13 participants either discontinued, could not complete the MRI, or did not complete the baseline and therefore were not scanned.|||cubic centimeters||Standard Deviation|Mean
2637547|NCT01780974|Primary|Trails Making Test Part B (Executive Function)|"The trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient should be instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Time the patient as he or she connects the trail. If the patient makes an error, point it out immediately and allow the patient to correct it. Results for part B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment."|Baseline, 6 months, and 12 months|Not all tests were completed by all randomized subjects due to missed visits and/or discontinuations.|||time to completion (seconds)||Standard Deviation|Mean
2637548|NCT01780935|Secondary|Frequency and Severity of Ocular and Non-ocular Adverse Events Over Time|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Screening to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
2637549|NCT01780935|Secondary|Change From Baseline in the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) Scores Over Time|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
2637550|NCT01780935|Secondary|Treatment Patterns Over Time in Both Treatment Arms|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
2637568|NCT01780922|Primary|Interleukin-2 (IL-2) Concentrations in Plasma||0, 2, 4, 8, 24 h||||pg/mL||Standard Error|Mean
2637569|NCT01780922|Primary|Interleukin-1beta (IL-1b) Concentrations in Plasma||0, 2, 4, 8, 24 h||||pg/mL||Standard Error|Mean
2637551|NCT01780935|Secondary|Change From Baseline in Lesion Size and Morphology Based on Fluorescein Angiography at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
2637552|NCT01780935|Secondary|Dry Retina in the Study Eye on OCT at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
2637553|NCT01780935|Secondary|Change From Baseline in Central Sub-Field Thickness (CSFT) and Central Sub-Field Volume (CSFV) of the Study Eye Over Time|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
2637554|NCT01780935|Secondary|Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and 24 in the Study Eye|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
2637555|NCT01780935|Secondary|Average Visual Acuity Change From Month 3 to Month 4 Through Month 24 in the Study Eye|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Month 3 to Month 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
2637556|NCT01780935|Secondary|Visual Acuity of 73 Letters or More in the Study Eye at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
2637557|NCT01780935|Secondary|Loss of Less Than 5, 10, and 15 Letters in Visual Acuity in the Study Eye From Baseline, at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
2637558|NCT01780935|Secondary|Gain of Equal or More Than 1, 5, 10, or 15 Letters in Visual Acuity of the Study Eye From Baseline, at Month 12 and 24|During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.|Baseline to Month 12 and 24|Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed||||||
2637559|NCT01780935|Secondary|Change From Baseline in Visual Acuity (Letters) of the Study Eye up to Month 12|Visual acuity (VA) was assessed using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged from Baseline to Month 12 Level of VA (Letters) of the Study Eye.|up to Month 12|Full Analysis Set (FAS) includes all randomized patients|||letters correctly read||Standard Deviation|Mean
2637560|NCT01780935|Primary|Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12|Visual acuity (VA) was assessed during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged up to Month 12 Level of VA (Letters) of the Study Eye.|up to Month 12|Full Analysis Set (FAS) includes all randomized patients|||Letters correctly read||Standard Deviation|Mean
2637561|NCT01780922|Primary|Urinary Anti-bacteria Adhesion Activity||0, 3, 6, 9, 12, 24 h||||mg PAC/mg creatinine||Standard Error|Mean
2637562|NCT01780922|Primary|Tumor Necrosis Factor-alpha (TNF-a) Concentrations in Plasma||0, 2, 4, 8, 24 h||||pg/mL||Standard Error|Mean
2637563|NCT01780922|Primary|Interferon-gamma (IFN-y) Concentrations in Plasma||0, 2, 4, 8, 24 h||||pg/mL||Standard Error|Mean
2637564|NCT01780922|Primary|Interleukin-10 (IL-10) Concentrations in Plasma||0, 2, 4, 8, 24 h||||pg/mL||Standard Error|Mean
2637582|NCT01780662|Secondary|Plasma Level of Thymus and Activation-Regulated Chemokine (TARC)|Limit to 41 evaluable patients who received dose 1.8 mg/kg|From baseline to time prior to cycle 2|4 eligible patients did not consent for genetic studies. 3 of the 41 did not have baseline TARC and 6 did not have TARC prior to cycle 2.|||pg/ml||Full Range|Median
2637583|NCT01780662|Secondary|The Number of Patients Who Had Successful Peripheral Blood Stem Cell (PBSC) Collection|Successful PBSC collection was defined as a collection of more than 2x10^6 CD34 positive cells.|From 1 to 5 cycles|For 21 of the eligible 45 subjects, PBSC collection was not attempted during protocol therapy, either because stem cells had been collected prior to study enrollment, or no autologous stem cell transplant was planned. 1 patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.|||Participants|||Count of Participants
2637584|NCT01780662|Secondary|Percentage of Patients Who Achieved Overall Response (OR) as Measured by Complete Response (CR) and Partial Response (PR)|The percentage of patients who experienced complete Response (CR) within the first four cycles.By modern response criteria, those with partial response (PR) or stable disease with all target lesions with Deauville scores <=3 after cycle 4 are also considered as CR. Patients were assessed after treatment with four cycles of gemcitabine with brentuximab vedotin. CR was only reported for Dose level 2 across both phases of study.|After 4 cycles (21 days per cycle) of protocol therapy|All eligible patients (N=42) at Dose Level 2 (brentuximab vedotin 1.8 mg/kg with gemcitabine).4 patients were excluded. 3 patients did not receive dose level 2 and 1 patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.|||percentage of participants||95% Confidence Interval|Number
2637585|NCT01780662|Secondary|The Number of Patients Who Had Disease Response Assessed by Deauville Scales Among Those in Phase I With Dose Level 2.|The Deauville five-point scale was used to assess the number of participants with complete response (CR) and partial response (PR). A lower score indicates a better outcome. Scores of 1-3 represent CR and 4-5 represent PR.|Up to 13 months from first dose|All eligible patients in phase 1, dose level 2 (N=13). 3 patients in phase 1 were not given dose level 2.|||Participants|||Count of Participants
2637586|NCT01780662|Primary|The Number of Patients With Relapsed or Refractory HL Who Achieved Complete Response (CR)|The number of patients who experienced complete Response (CR) within the first four cycles. By modern response criteria, those with partial response (PR) or stable disease with all target lesions with Deauville scores <=3 after cycle 4 are also considered as CR. Patients were assessed after treatment with four cycles of gemcitabine with brentuximab vedotin. CR was only reported for Dose level 2 across both phases of study.|After 4 cycles (21 days per cycle) of protocol therapy|All eligible patients (N=42) at Dose Level 2 (brentuximab vedotin 1.8 mg/kg with gemcitabine). 4 patients were excluded. 3 patients did not receive dose level 2 and 1 patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.|||Participants|||Count of Participants
2637587|NCT01780662|Primary|Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|The number of eligible patients assigned to receive brentuximab vedotin in combination with gemcitabine that experienced CTC Version 4, grade 3 or higher adverse events during Phase 1 and Phase 2.|13 months from first dose|All eligible patients (N=45). One patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.|||Participants|||Count of Participants
2637588|NCT01780662|Primary|Maximum Tolerated Dose (MTD) for Brentuximab Vedotin|MTD was determined as the maximum dose at which fewer than one-third of patients experience Dose Limiting Toxicities (DLT) as assessed by National Cancer Institute (NCI) CTCAE v 4.0 during Cycle 1 of therapy. Gemcitabine was administered on days 1 and 8 of a 21 day cycle at a fixed dose. Brentuximab vedotin was investigated at a starting dose of 1.4 mg/kg administered on day 1 and escalated if tolerated.|During cycle 1 of protocol therapy (21 days)|The first 9 out of 16 patients enrolled with relapsed/refractory HL in a phase 1 dose finding study of brentuximab vedotin in combination with gemcitabine, were used in determining MTD|||mg/kg|||Number
2637589|NCT01780584|Other Pre-specified|Postoperative Hospital Length of Stay||up to 3 month after surgery||||days||Full Range|Median
2637590|NCT01780584|Other Pre-specified|Postoperative Length of Stay in Intensive Care Unit||up to 3 months after surgery||||hours||Full Range|Median
2637591|NCT01780584|Other Pre-specified|Postoperative Time to Extubation|Postoperative time to extubation is length of time on ventilator.|up to 3 months after surgery||||hours||Full Range|Median
2637592|NCT01780584|Secondary|Number of Patients With Possible Side Effects of Thyroid Hormone Supplementation Particularly Suggesting Hyperthyroid Symptoms.|Specific symptoms of hyperthyroidism included cardiac dysrhythmia requiring medical or electrical treatment, hypertension (mean systolic or diastolic blood pressure more than 2 standard deviation above normal for age) and hyperthermia (>37.5 degree Celsius). One patient in low dose group had hypertension directly after surgery due to unrecognized coarctation of the aorta and this patient was withdrawal from the protocol.|Since the first dose of oral T3 until 7 days after surgery|Three patients were excluded from adverse effect analysis. Two patients, each in placebo and high dose group were on Extracorporeal Membrane Oxygenation. One patient in high dose group could not attained enteral feeds due to gastrointestinal bleeding and was withdrawal from the protocol.|||participants|||Number
2637593|NCT01780584|Primary|Free T3 (FT3) Levels|Free T3 levels were measured up to 36 hours after cross-clamp removal|during the first 36 hours after cross clamp removal|Two subjects (one in T3 low dose and one in T3 high dose) were withdrawn from the treatment protocol. The withdrawal in low dose group was because of severe hypertension caused by a previously unrecognized coarctation of the aorta, and the high dose group withdrawal was due to massive gastrointestinal bleeding.|||pg/ml||Standard Error|Mean
2637594|NCT01780545|Secondary|Effect of Therapy Regimen on Circulating Tumor Cells (CTCs)and Correlative Analysis of Telomerase Activity|To evaluate the effect of therapy with docetaxel and OGX-427 on peripheral blood circulating tumor cells (CTCs) enumeration and expression of Hsp27 and other relevant proteins via immunoflourescence, and levels of telomerase by quantitative polymerase chain reaction (PCR), and explore their relation with clinical outcomes.|Prior to screening, prior to first loading dose, and prior to cycles 1, 2, 3 and 5|Data for this secondary objective was not collected or analyzed.||||||
2637595|NCT01780545|Secondary|Hsp27 Expression in Archival Tissue|To evaluate the association of urothelial carcinoma expression of Hsp27 measured by immunohistochemistry (IHC) in archival tissue with clinical outcomes.|Cycle 1|Data for this secondary outcome was not collected or analyzed.||||||
2637598|NCT01780545|Secondary|Safety and Toxicity of Regimen|To compare the safety and toxicity of OGX-427 in combination with docetaxel to that of docetaxel alone. A summary of per-patient maxiumy grade adverse events of any type is included in the Outcome Measure. Full adverse event information will be submitted further in the record.|36 Months|190 participants who intiated protocol treatment were included in the safety population|||Participants|||Count of Participants
2637599|NCT01780545|Primary|Overall Survival|To determine whether docetaxel administered in combination with OGX-427 provides a survival benefit compared to docetaxel alone.|36 Months||||months||95% Confidence Interval|Median
2637600|NCT01780506|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 144|Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.|||percent change||Inter-Quartile Range|Median
2637601|NCT01780506|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96|Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||percent change||Inter-Quartile Range|Median
2637602|NCT01780506|Secondary|Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48|Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||percent change||Inter-Quartile Range|Median
2637603|NCT01780506|Secondary|Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 144|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 144|Participants in the Safety Analysis Set with available data were analyzed.|||percent change||Inter-Quartile Range|Median
2637604|NCT01780506|Secondary|Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 96|Participants in the Safety Analysis Set with available data were analyzed.|||percent change||Inter-Quartile Range|Median
2637605|NCT01780506|Secondary|Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48|Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.|Baseline; Week 48|Participants in the Safety Analysis Set with available data were analyzed.|||percent change||Inter-Quartile Range|Median
2637606|NCT01780506|Secondary|Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 144|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.|Up to 144 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.|||percentage of participants|||Number
2637607|NCT01780506|Secondary|Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 96|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.|Up to 96 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.|||percentage of participants|||Number
2637608|NCT01780506|Secondary|Percentage of Participants Experiencing Treatment-emergent Proteinuria Through Week 48|Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.|Up to 48 weeks|Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.|||percentage of participants|||Number
2637609|NCT01780506|Secondary|Change From Baseline in Serum Creatinine at Week 144||Baseline; Week 144|Safety Analysis Set. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.|||mg/dL||Standard Deviation|Mean
2637610|NCT01780506|Secondary|Change From Baseline in Serum Creatinine at Week 96||Baseline; Week 96|Safety Analysis Set. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.|||mg/dL||Standard Deviation|Mean
2637611|NCT01780506|Secondary|Change From Baseline in Serum Creatinine at Week 48||Baseline; Week 48|Safety Analysis Set. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.|||mg/dL||Standard Deviation|Mean
2637612|NCT01780506|Secondary|Percent Change From Baseline in Spine BMD at Week 144|Spine BMD was assessed by DXA scan.|Baseline; Week 144|Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.|||percent change||Standard Deviation|Mean
2637613|NCT01780506|Secondary|Percent Change From Baseline in Spine BMD at Week 96|Spine BMD was assessed by DXA scan.|Baseline; Week 96|Spine DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.|||percent change||Standard Deviation|Mean
2637614|NCT01780506|Secondary|Percent Change From Baseline in Spine BMD at Week 48|Spine BMD was assessed by DXA scan.|Baseline; Week 48|Spine DXA Analysis Set: participants who were randomized and received at least 1 dose of study drugs and had nonmissing baseline spine BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.|||percent change||Standard Deviation|Mean
2637615|NCT01780506|Secondary|Percent Change From Baseline in Hip BMD at Week 144|Hip BMD was assessed by DXA scan.|Baseline; Week 144|Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.|||percent change||Standard Deviation|Mean
2637616|NCT01780506|Secondary|Percent Change From Baseline in Hip BMD at Week 96|Hip BMD was assessed by DXA scan.|Baseline; Week 96|Hip DXA Analysis Set. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.|||percent change||Standard Deviation|Mean
2647022|NCT01699022|Primary|MPA Concentrations|Assessment of mean trough levels of MPA on Day 1, Day 29, Day 57 and Day 85|"Day 1, Day 29, Day 57' and 'Day 85"||||ng/mL||Standard Deviation|Mean
2637617|NCT01780506|Secondary|Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48|Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.|Baseline; Week 48|Hip DXA Analysis Set: participants who were randomized and received at least 1 dose of study drugs and had nonmissing baseline hip BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach was used, where participants with missing data were excluded from the analysis.|||percent change||Standard Deviation|Mean
2637618|NCT01780506|Secondary|Change From Baseline in CD4+ Cell Count at Week 144||Baseline; Week 144|Participants in the Full Analysis Set with on-treatment data were analyzed.|||cells/µL||Standard Deviation|Mean
2637619|NCT01780506|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with on-treatment data were analyzed.|||cells/µL||Standard Deviation|Mean
2637620|NCT01780506|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with on-treatment data were analyzed.|||cells/µL||Standard Deviation|Mean
2637621|NCT01780506|Secondary|Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48, 96, and 144|The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48, 96, and 144 were analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Weeks 48, 96. and 144|Full Analysis Set|||percentage of participants|||Number
2637622|NCT01780506|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 96 and 144|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Weeks 96 and 144 were analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Weeks 96 and 144|Full Analysis Set|||percentage of participants|||Number
2637623|NCT01780506|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set: participants who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2637624|NCT01780389|Secondary|Change in Total Score of Short Form-36 (SF-36), Measuring Perceived Quality of Life|"Subjective measure of perceived quality of life.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.~The eight sections are:~vitality,~physical functioning,~bodily pain,~general health perceptions,~physical role functioning,~emotional role functioning,~social role functioning,~mental health~Scale:~0= lowest quality of life 100= high quality of life Higher scores reflect higher quality of life. Total mean cumulative scores were reported."|baseline and endpoint (12 weeks or early termination)||||units on a scale||Standard Deviation|Mean
2637625|NCT01780389|Secondary|Change in Total Score of State Trait Anxiety Inventory (STAI)|"Assessment of subjective symptoms of current anxiety and chronic anxiety. There are 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: I am tense; I am worried and I feel calm; I feel secure. Trait anxiety items include: I worry too much over something that really doesn't matter and I am content; I am a steady person. All items are rated on a 4-point scale (e.g., from Almost Never to Almost Always). Higher scores indicate greater anxiety.~Lowest total score is 40 (absent anxiety) Highest total score is 160 (maximum anxiety) Total mean cumulative scores were reported."|baseline and endpoint (12 weeks or early termination)||||units on a scale||Standard Deviation|Mean
2637626|NCT01780389|Secondary|Change in the Montgomery Asberg Depression Rating Scale|"Staff-rated assessment of depressive symptoms. Scale is as follows:~0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression"|Between baseline and endpoint (12 weeks or early termination)||||units on a scale||Standard Deviation|Mean
2637627|NCT01780389|Secondary|Change in the Beck Depression Inventory (BDI-II)|"The secondary outcome measure is change in Beck Depression Inventory. The scale for this inventory is:~0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. The higher the score the degree of depression."|Baseline to endpoint (12 weeks or early termination)||||units on a scale||Standard Deviation|Mean
2637628|NCT01780389|Secondary|Change in Total Score of Multidimensional Fatigue Inventory (MFI-20)|"Measures subjective fatigue.20-item self-report instrument consisting of five scales: General Fatigue, Physical Fatigue, Reduced Activity, Reduced Motivation, and Mental Fatigue.~Each scale contains four items rated on a scale of one to 5 with the scale score of one having the anchor of entirely true and the scale score of 5 having the anchor of no, not true. The five scales were identified through factor analysis and are assumed to measure different aspects of fatigue. Lowest possible total score = 20 (absent fatigue) Highest possible total score = 100 (maximum fatigue) Total mean cumulative scores were reported"|Baseline to endpoint (12 weeks or early termination)||||units on a scale||Standard Deviation|Mean
2637629|NCT01780389|Secondary|Global Rating of Change||Endpoint (12 weeks or early termination)|Data not collected.||||||
2637630|NCT01780389|Secondary|Change in Knee Society Score (KSS).|"KSS measures subjective pain and objective function by joint physical exam. This secondary outcome was the change in Knee Society Score(KSS)from baseline through 12 weeks.~KSS scores measured on a scale of 0 to 100 mm:~0 = absence of pain or no pain noted 100= worst imaginable pain/as bad as can be The higher the score the greater the over all pain intensity."|between baseline and endpoint (12 weeks or early termination)||||units on a scale||Standard Deviation|Mean
2637631|NCT01780389|Primary|Change in Pain Visual Analogue Scale(VAS).|"The primary outcome is change in pain VAS from baseline to 12 weeks (baseline score minus 12 week or endpoint score; positive number reflects reduction in pain score). The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm:~0= absence of pain or no pain noted 100 = worst imaginable pain/as bad as can be The higher the score the greater the over all pain intensity."|baseline and endpoint 12 weeks||||units on a scale||Standard Deviation|Mean
2638562|NCT01772576|Other Pre-specified|Pacing Threshold|Pacing Threshold at 0.5 ms pulse width at 3 Months Post-Implant|3-months post-implant|Patients having undergone the 3 months follow-up visit.|||Volt||95% Confidence Interval|Mean
2637632|NCT01780350|Secondary|Tolerability|Determine patient tolerability of the device while breathing through it. This is subjectively measured by the paramedic administering the device based on verbal reporting from the patient and paramedic estimation of the patient response to the device.|Duration of device use, up to 1 hour||||participants|||Number
2637633|NCT01780350|Primary|Change in Systolic Blood Pressure From Baseline (Before ITD Use)|Determining whether the application of an ITD will provide improvement in systolic blood pressure in subjects with hypotension in patients being treated by San Antonio EMS when compared to baseline.|During device use, up to 1 hour||||mmHg||Standard Deviation|Mean
2637634|NCT01780337|Primary|Change in Electrophysiology Measure of Right Ventricular Refractory Period|First measured at time zero, then at 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, the investigators will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'pre- ablation' period normally takes 45 minutes to one hour.|Baseline and 30 min|Only 4 out of 6 were evaluable for the Oxytocin group.|||milliseconds||Standard Deviation|Mean
2637635|NCT01780337|Primary|Change in Electrophysiology Measure of HV Interval|First measured at time zero, then at 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, the investigators will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'pre- ablation' period normally takes 45 minutes to one hour.|Baseline and 30 min|Only 4 out of 6 were evaluable for the Oxytocin group. Only 5 out of 6 were evaluable for the Saline group.|||milliseconds||Standard Deviation|Mean
2637636|NCT01780337|Primary|Change in Electrophysiology Measure of AH Interval|First measured at time zero, then at 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, the investigators will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'pre- ablation' period normally takes 45 minutes to one hour.|Baseline and 30 min|Only 3 out of 6 were evaluable for the Oxytocin group. Only 2 out of 6 were evaluable for the Saline group.|||milliseconds||Standard Deviation|Mean
2637637|NCT01780324|Primary|Pain Score on the Face, Legs, Arms, Cry, Consolability (FLACC) Scale|Pain of urethral catheterization will be determined in the lidocaine and no lidocaine groups. Score range for the FLACC scale was between 0-10 where higher score is more pain.|At time of procedure (up to 30 seconds after catheter insertion)||||units on a scale||95% Confidence Interval|Median
2637638|NCT01779869|Primary|Diagnostic Accuracy of Cardiac PET/MRI Examination|"The accuracy of the cardiac PET and cardiac MR examination components of the PET/MRI, and the accuracy of the combined PET/MR examination, for ischemic heart disease will be compared to the accuracy of cardiac SPECT in patients who have had ICA as truth or the reference standard. To assess the accuracy of an abbreviated PET/MR examination, an additional accuracy analysis was made using only the stress PET perfusion imaging and the MR LGE data sets. The accuracy of this combined data set was also determined with ICA as truth or the reference standard. Accuracy is calculated as % difference = (experimental - true) x 100%."|PET/MRI imaging was performed within 10 days after SPECT-MPI examination|Patients who completed the full PET-MR myocardial perfusion examination|||percentage||95% Confidence Interval|Number
2637639|NCT01779700|Secondary|Plasma Cytokines Levels - IFNgamma|To assess IFNgamma plasma cytokines levels changes in participants taking fingolimod versus placebo|Baseline, 4 weeks, 8 weeks||||pg/ml||Standard Deviation|Mean
2637640|NCT01779700|Secondary|Plasma Cytokines Levels - TNFa|To assess TNFa plasma cytokines levels changes in participants taking fingolimod versus placebo|Baseline, 4 weeks, 8 weeks||||pg/ml||Standard Deviation|Mean
2637641|NCT01779700|Secondary|Plasma Cytokines Levels - IL-8|To assess IL-8 plasma cytokines levels changes in participants taking fingolimod versus placebo|Baseline, 4 weeks, 8 weeks||||pg/ml||Standard Deviation|Mean
2637642|NCT01779700|Secondary|Plasma Cytokines Levels - IL-6|To assess IL-6 plasma cytokines levels changes in participants taking fingolimod versus placebo|Baseline, 4 weeks, 8 weeks||||pg/ml||Standard Deviation|Mean
2637643|NCT01779700|Secondary|Plasma Cytokines Levels - IL-4|To assess IL-4 plasma cytokines levels changes in participants taking fingolimod versus placebo|Baseline, 4 weeks, 8 weeks||||pg/ml||Standard Deviation|Mean
2637644|NCT01779700|Secondary|Plasma Cytokines Levels - IL-2|To assess IL-2 plasma cytokines levels changes in participants taking fingolimod versus placebo|Baseline, 4 weeks, 8 weeks||||pg/ml||Standard Deviation|Mean
2637645|NCT01779700|Secondary|Plasma Cytokines Levels - IL-1BETA|To assess IL-1BETA plasma cytokines levels changes in participants taking fingolimod versus placebo|Baseline, 4 weeks, 8 weeks||||pg/ml||Standard Deviation|Mean
2637646|NCT01779700|Secondary|Plasma Cytokines Levels - IL-17A|To assess IL-17A plasma cytokines levels changes in participants taking fingolimod versus placebo|Baseline, 4 weeks, 8 weeks||||pg/ml||Standard Deviation|Mean
2637647|NCT01779700|Secondary|Plasma Cytokines Levels - IL-10|To assess IL-10 plasma cytokines levels changes in participants taking fingolimod versus placebo|Baseline, 4 weeks, 8 weeks||||pg/ml||Standard Deviation|Mean
2637648|NCT01779700|Secondary|Negative Symptom Change - PANSS|The Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview, containing 30 items that assess symptoms of psychotic disorders including positive, negative, and general psychopathology symptoms. Positive symptoms are rated on 7 items, negative symptoms are rated on 7 items, and general psychopathology on 16 items. Scores for each item range from 1=absent to 7=extreme. Positive, negative, and general psychopathology symptoms can each respectively render total scores. Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psychopathology scores ranging from 16-112. When all items are summed together a total score is generated. Total scores for all items range from 30-210, a lower score reflecting fewer symptoms.|Baseline, 4 weeks, 8 weeks||||score on a scale||Standard Deviation|Mean
2637684|NCT01779167|Secondary|Number of Adverse Events Experienced With Alternating Thalidomide and Lenalidomide Plus Rituximab for Subjects With Previously Treated Waldenstrom's Macroglobulinemia|Capture the number of adverse events experienced when combining thalidomide, lenalidomide, and rituximab in patients with previously treated WM|approximately 24 months per patient|Data was not collected due to early termination.||||||
2637649|NCT01779700|Secondary|Positive Symptom Change - PANSS|The Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview, containing 30 items that assess symptoms of psychotic disorders including positive, negative, and general psychopathology symptoms. Positive symptoms are rated on 7 items, negative symptoms are rated on 7 items, and general psychopathology on 16 items. Scores for each item range from 1=absent to 7=extreme. Positive, negative, and general psychopathology symptoms can each respectively render total scores. Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psychopathology scores ranging from 16-112. When all items are summed together a total score is generated. Total scores for all items range from 30-210, a lower score reflecting fewer symptoms.|Baseline, 4 weeks, 8 weeks||||score on a scale||Standard Deviation|Mean
2637650|NCT01779700|Secondary|Cognition Change - Trails B|The Trail Making Test-Part B (Trails B) is a measure of visual attention and task switching. The task requires a subject to 'connect-the-dots' of 25 consecutive targets on a sheet of paper. In Part B version the subject alternates between numbers and letters (1, A, 2, B, etc.) The goal of the test is for the subject is to finish part B as quickly as possible, the time taken to complete the test is used as the primary performance metric. The score is the number of seconds it took to complete the test.|Baseline, 4 weeks, 8 weeks||||seconds||Standard Deviation|Mean
2637651|NCT01779700|Secondary|Cognition Change - BACS|The Brief Assessment of Cognition in Schizophrenia (BACS) is a battery specifically designed to measure treatment-related changes in cognition by utilizing 6 tasks, and has alternate forms, thus minimizing practice effects. Each task generates a raw score (with a higher score indicating better performance): verbal memory 0-75; digit sequencing 0-28; token motor task 0-100; semantic&letter fluency 0-148; symbol coding 0-110; and tower of London 0-22. The raw scores are used to generate a composite score that is calculated by summing t-scores derived by comparisons with a normative sample of 404 healthy controls. The six brief assessments' t-scores, are summed, and averaged to provide a composite t-score. The composite score min and max are between -43 and 100. A higher score indicating better cognitive performance.|Baseline, 4 weeks, 8 weeks||||score on a scale||Standard Deviation|Mean
2637652|NCT01779700|Secondary|Verbal Memory - BACS|The Brief Assessment of Cognition in Schizophrenia (BACS) is a battery specifically designed to measure treatment-related changes in cognition. The BACS utilizes 6 tasks, and has alternate forms, thus minimizing practice effects. Each task generates a raw score (with a higher score indicating better performance): verbal memory 0-75; digit sequencing 0-28; token motor task 0-100; semantic&letter fluency 0-148; symbol coding 0-110; and tower of London 0-22. The raw scores are used to generate a composite score that is calculated by summing t-scores derived by comparisons with a normative sample of 404 healthy controls. The six brief assessments' t-scores, are summed, and averaged to provide a composite t-score. The composite score min and max are between -43 and 100. A higher score indicating better cognitive performance.|Baseline, 4 weeks, 8 weeks||||score on a scale||Standard Deviation|Mean
2637653|NCT01779700|Primary|Symptom Changes - PANSS Total Score|The Positive and Negative Syndrome Scale (PANSS) is a semi-structured interview, containing 30 items that assess symptoms of psychotic disorders including positive, negative, and general psychopathology symptoms. Positive symptoms are rated on 7 items, negative symptoms are rated on 7 items, and general psychopathology on 16 items. Scores for each item range from 1=absent to 7=extreme. Positive, negative, and general psychopathology symptoms can each respectively render total scores. Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psychopathology scores ranging from 16-112. When all items are summed together a total score is generated. Total scores for all items range from 30-210, a lower score reflecting fewer symptoms.|Baseline, 4 weeks, 8 weeks||||score on a scale||Standard Deviation|Mean
2637654|NCT01779700|Primary|Levels of Lymphocyte|To determine the safety of fingolimod, as measured by the absolute lymphocyte count|Baseline, 4 weeks, 8 weeks||||10^3 lymphocytes/uL||Standard Deviation|Mean
2637655|NCT01779700|Primary|QTcB Change|To determine the safety of fingolimod, as measured by the electrocardiogram (ECG) QT interval corrected by Bazett's (QTcB) value.|Screening, Day 0, Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56, Day 84, Day 112||||ms||Standard Deviation|Mean
2637656|NCT01779648|Secondary|Cycling Rate|Number of cuff inflation-deflation cycle during an hour. In group SF, the cycling rate is fixed as 90 cycles/hour, but in group AA, it is variable according to the individual venous refill time.|on 4th postoperative day after total knee replacement arthroplasty||||cycles/hour|Participants|Standard Deviation|Mean
2637657|NCT01779648|Secondary|Augmented TVF|Enhanced total volume flow by application of pneumatic compression|on 4th postoperative day after total knee replacement arthroplasty||||mL/min|Participants|Standard Deviation|Mean
2637658|NCT01779648|Secondary|Augmented PVF|Enhanced peak volume flow by application of pneumatic compression|On 4th postoperative days after total knee replacement arthroplasty||||mL/min|Participants|Standard Deviation|Mean
2637659|NCT01779648|Secondary|Augmented MV|Enhanced mean velocity by application of pneumatic compression|On 4th postoperative days after total knee replacement arthroplasty||||cm/sec|Participants|Standard Deviation|Mean
2637660|NCT01779648|Secondary|Augmented PV|Enhanced peak velocity by application of intermittent pneumatic compression|On 4th postoperative days after total knee replacement arthroplasty||||cm/sec|Participants|Standard Deviation|Mean
2637661|NCT01779648|Secondary|Expelled Peak Volume|Expelled volume was theoretically calculated value in order to figure out how much blood was squeezed by the compression for an hour; expelled peak volume (EPV) = single cycle augmented PVF x cycling rate (cycles/hour).|On 4th postoperative days after total knee replacement arthroplasty||||mL/hour|Participants|Standard Deviation|Mean
2637662|NCT01779648|Secondary|Expelled Total Volume|Expelled volume was theoretically calculated value in order to figure out how much blood was squeezed by the compression for an hour; expelled total volume (ETV) = single cycle augmented TVF x cycling rate (cycles/hour).|On 4th postoperative days after total knee replacement arthroplasty||||mL/hour|Participants|Standard Deviation|Mean
2637663|NCT01779648|Secondary|Total Volume Flow|Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Total volume flow (TVF) was automatically calculated by the software.|On 4th postoperative days after total knee replacement arthroplasty||||mL/min||Standard Deviation|Mean
2637664|NCT01779648|Secondary|Peak Volume Flow|Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Peak volume flow (PVF) was automatically calculated with 1-second interval around the PV.|On 4th postoperative days after total knee replacement arthroplasty||||mL/min||Standard Deviation|Mean
2637665|NCT01779648|Secondary|Mean Velocity|Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Alternate compression arm) or 12 seconds (Simultaneous compression arm) were recorded. This is an automatically measured mean value of venous flow.|On 4th postoperative days after total knee replacement arthroplasty||||cm/sec||Standard Deviation|Mean
2637666|NCT01779648|Secondary|Peak Velocity|Doppler ultrasonography were performed to measure one of the venous hemodynamic parameters to be compared. A longitudinal scans of bilateral superficial femoral veins, just distal to the confluence of the profunda femoral veins, were performed. Baseline velocity, flow pattern, and augmented flow of 11 seconds (Simultaneous compression arm) or 12 seconds (Alternate compression arm) were recorded. Under fixed state of other ultrasound scan parameters, peak velocity (PV) was measured by determination of maximum point of the augmented waveform.|On 4th postoperative days after total knee replacement arthroplasty||||cm/sec||Standard Deviation|Mean
2637667|NCT01779648|Primary|Rate of Deep Vein Thrombosis|Computed tomographic angiography were performed on 4th postoperative days to detect deep vein thrombosis and evaluate its extent and location.|On 4th postoperative days after total knee replacement arthroplasty|One participant of Group SF dropped out of the analysis due to the device error; air leakage in the closed circuit system.|||participants|||Number
2637668|NCT01779440|Secondary|Number of Participants With Biologically Confirmed Abstinence|Abstinence - self report for past 7 days confirmed with breath Carbon Monoxide <9 ppm|14 weeks|Participants who attended the follow-up assessment|||Participants|||Count of Participants
2637669|NCT01779440|Primary|Number of Participants Who Utilized Smoking Cessation Treatment|Assesses through clinician confirmation any engagement in behavioral smoking cessation treatment and/or smoking cessation medication treatment.|14 week follow-up||||Participants|||Count of Participants
2637670|NCT01779375|Other Pre-specified|OGTT Measures of ß-cell Function and Glucose Tolerance|Measures derived the OGTT at the end of the 12 month active intervention period, and following a 3-month and 9-month washout.|After 12 months of active treatment, and 3 and 9 months of washout||2020-06-30|06/2020||||
2637671|NCT01779375|Secondary|Clamp Measure of Insulin Sensitivity|Participants had 12-months of active therapy. Secondary results at the end of active intervention.|End of active intervention (Month 12)|Secondary analysis was on all participants with a Month 12 visit.|||x 10-5 mmol/kg/min per pmol/L||95% Confidence Interval|Mean
2637672|NCT01779375|Secondary|ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12|Participants had 12-months of active therapy. Secondary results at the end of active intervention.|End of active intervention (Month 12).|Secondary analysis was on all participants with a Month 12 visit.|||nmol/L||95% Confidence Interval|Mean
2637673|NCT01779375|Secondary|ACPRg|First phase response|3-months after a medication washout|Primary analysis was on all participants able to have a M15 visit.|||nmol/L||95% Confidence Interval|Mean
2637674|NCT01779375|Primary|M/I|Clamp measure of insulin sensitivity|3-months after a medication washout|All participants with a Month 15 visit|||x 10-5 mmol/kg/min per pmol/L||95% Confidence Interval|Mean
2637675|NCT01779375|Primary|ß-cell Response Measured by Hyperglycemic Clamp|Clamp measures of ß-cell response, co-primary outcomes|3-months after medication washout (Month 15)|Primary analysis was on all participants able to have a M15 visit. 2 participants in the metformin alone arm decompensated at M12 and were unable to remain off treatment until M15. A sensitivity analysis including these 2 participants using 1/2 of the worst value among all other participants did not alter the results.|||nmol/L||95% Confidence Interval|Mean
2637676|NCT01779219|Secondary|Time|the preparation (Tprep), operation (Top) and total operating room (TOR) time|From moment of the transfer to the OR until the moment of transfer out of it, assessed on the day of operation.||||minutes||Standard Deviation|Mean
2637677|NCT01779219|Secondary|Length of Hospital Stay|The preoperative (LOSpre), postoperative (LOSpost) and total length of hospital stay (LOS)|From date of hospitalization until the date of discharge, assessed up to 2 days.||||days||Full Range|Median
2637678|NCT01779219|Primary|Diagnostic Yield|The diagnostic yield is expressed as the number of patients in whom the histopathological diagnosis was made based of the biological material obtained during the operation.|For each patient 2 weeks after the operation||||participants|||Number
2637679|NCT01779219|Primary|Number of Participants Presenting With Complications|The presence of acute postoperative complication is noted if any of following findings is present: wound site infection up to two weeks after the operation, a new neurological deficit developed up to 24 hours following the operation and present in a follow up clinical examination 2 weeks postoperatively, intraparenchymal hematoma with radiological or clinical signs of the intracranial expansion.|Patients were followed for the duration of hospital stay (average 2 days) and again 2 weeks after the operation.|Complications assessed: Haematoma, Neurological deterioration, Infection|||participants|||Number
2637680|NCT01779167|Secondary|Response Duration of Subjects Treated With THRiL for WM|Measure response duration of patients enrolled on THRiL for WM|24 months|Data was not collected due to early termination.||||||
2637681|NCT01779167|Secondary|Time to Response|Measure the time from initiating therapy to demonstrating response in WM.|approximately 24 months|Data was not collected due to early termination.||||||
2637682|NCT01779167|Secondary|Rate of Rituximab Related IgM Flare|Estimate the rate of rituximab-related IgM flare|Approximately 24 months per patient|Data was not collected due to early termination.||||||
2637683|NCT01779167|Secondary|Survival of Subjects Treated With THRiL for WM.|Estimate overall survival of patients enrolled on THRiL for WM.|approximately 24 months per patient|Data was not collected due to early termination.||||||
2637786|NCT01777945|Secondary|Percentage of Capecitabine Dose Modifications||approximately 2 years||||percentage of doses|||Number
2637685|NCT01779167|Primary|Number of Patients Who Demonstrate a Response (Complete, Partial, Minor) to Treatment|"Response criteria for subjects with WM is based upon the Consensus Panel Recommendations from the Third International Workshop on Waldenstrom Macroglobulinemia.~Overall response rate (CR + PR + MR) measured at time of best response."|Approximately 24 months||||participants|||Number
2637686|NCT01779141|Secondary|Unhealthy Babies|The number of participants who delivered babies classified as large for gestational age, with congenital malfunction, or who required mechanical ventilation.|from birth to 6 weeks after delivery|Participants who delivered alive babies|||Participants|||Count of Participants
2637687|NCT01779141|Secondary|Large for Gestational Age (LGA)|Percentage of mothers who delivered LGA babies. The Babies whose weight were greater than 90th percentiles at the gestational age when they were born, were defined as LGA Babies. (reference: Fetal biometry between 20-42 weeks of gestation for Polish population).|after birth|Participants who delivered live babies|||Participants|||Count of Participants
2637688|NCT01779141|Primary|Percent of Sensor Glucose Values in 70-140 mg/dL|Percent of sensor glucose values between and including 70 mg/dL to 140 mg/dL|During pregnancy|Subjects with sensor information during pregnancy|||percentage of available sensor values||Standard Deviation|Mean
2637689|NCT01779141|Primary|HbA1c|Changes in HbA1C from baseline to after delivery.|from preconception phase to 6 weeks after delivery|Participants who have both baseline HbA1C and after delivery HbA1C available.|||HbA1C percentage||Standard Deviation|Mean
2637690|NCT01779024|Primary|Alcohol Infusions Self-administered|The total number of alcohol infusions self-administered.|120 minutes after the start of the infusion|The analyses included only those subjects who completed all types of infusions (Ghrelin and Placebo) and had alcohol self-administration|||Number of alcohol infusions||Standard Error|Mean
2637691|NCT01778985|Secondary|Estimated Blood Loss|Intraoperative estimated blood loss|Time of surgery, i.e. after 6-8 weeks of intervention|In both study arms, 13 participants did undergo surgery and, therefore, had an estimated blood loss value available for analysis. However, one patient each from both study arms did not have biopsies taken (technical considerations/ intraoperative decision or conversion from total to supracervical hysterectomy without ability to collect biopsy).|||mL||Standard Deviation|Mean
2637692|NCT01778985|Primary|Vaginal Wall Degradative Activity, Mucosa, MMP-9|Will assess zymograms for total matrix metalloprotease (MMP) 9 activity|Time of surgery, i.e. after 6-8 weeks of intervention|All specimens with sufficient amount of tissue available for zymography analysis were used.|||Relative Units/mg protein||Standard Error|Mean
2637693|NCT01778985|Primary|TGFB1 (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention||||ratio||Standard Error|Mean
2637694|NCT01778985|Primary|Tropoelastin (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention||||ratio||Standard Error|Mean
2637695|NCT01778985|Primary|LOXL1 (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention||||ratio||Standard Error|Mean
2637696|NCT01778985|Primary|Lysyl Oxidase (LOX) (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention||||ratio||Standard Error|Mean
2637697|NCT01778985|Primary|hCOL3, (Per-Protocol)|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention||||ratio||Inter-Quartile Range|Median
2637698|NCT01778985|Primary|Vaginal Wall Composition: Lamina Propria (Per-Protocol)|Will assess vaginal wall histology - thickness of lamina propria|Time of surgery, i.e. 6-8 weeks of intervention||||microns||Standard Error|Mean
2637699|NCT01778985|Primary|Vaginal Wall Composition: Lamina Propria (Intention to Treat)|Will assess vaginal wall histology - thickness of lamina propria.|Time of surgery, i.e. after 6-8 weeks of intervention||||microns||Standard Error|Mean
2637700|NCT01778985|Secondary|Serum Estradiol Levels, Surgery||Time of surgery||||pg/mL||Standard Error|Mean
2637701|NCT01778985|Secondary|Serum Estradiol Levels, Baseline||Baseline||||pg/mL||Standard Error|Mean
2637702|NCT01778985|Secondary|Serum Estrone Levels, Surgery||Time of surgery||||pg/mL||Standard Error|Mean
2637703|NCT01778985|Primary|Vaginal Wall Degradative Activity, Muscularis, MMP-9|Will assess zymograms for total matrix metalloprotease (MMP) 9 activity|Time of surgery, i.e. after 6-8 weeks of intervention|All specimens with sufficient amount of tissue available for zymography analysis were used.|||Relative Units/mg protein||Standard Error|Mean
2637704|NCT01778985|Primary|Total Collagen Content in Vaginal Muscularis, (Per-Protocol)|Will assess hydroxy-proline assays as index of amount of collagen|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication (per protocol)"|||mg collagen per mg muscularis wet weight||Standard Error|Mean
2637705|NCT01778985|Secondary|Serum Estrone Levels, Baseline||Baseline||||pg/mL||Standard Error|Mean
2637706|NCT01778985|Primary|hCOL1A1, Per-Protocol|Data represent ratio of total mRNA relative to postmenopausal external control.|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication (per protocol)"|||ratio||Inter-Quartile Range|Median
2637707|NCT01778985|Primary|Vaginal Wall Composition: Muscularis (Per-Protocol)|Will assess vaginal wall histology - thicknesses of muscularis|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication (per protocol)"|||microns||Standard Error|Mean
2637708|NCT01778985|Primary|Vaginal Wall Composition: Muscularis (Intention to Treat)|Will assess vaginal wall histology - thicknesses of muscularis|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis (intention to treat)"|||microns||Standard Error|Mean
2637709|NCT01778985|Primary|Vaginal Wall Composition: Epithelium (Per-Protocol)|Will assess vaginal wall histology - thicknesses of epithelium|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis and who were adherent to study medication (per protocol)"|||microns||Standard Error|Mean
2637787|NCT01777945|Secondary|Duration of Treatment With Xeloda||approximately 2 years||||treatment cycle||Standard Deviation|Mean
2637710|NCT01778985|Primary|Vaginal Wall Composition: Epithelium (Intention to Treat)|Will assess vaginal wall histology - thicknesses of epithelium|Time of surgery, i.e. after 6-8 weeks of intervention|"Patients completing surgery with biopsy specimens available for analysis (intention to treat)"|||microns||Standard Error|Mean
2637711|NCT01778855|Primary|Number of Participants With Recanalization|"To determine whether hypothermia alters recanalization with standard thrombolytic treatment with intravenous (IV) tissue plasminogen activator (tPA) for acute ischemic stroke in humans. The hypothesis is that hypothermia does not impair recanalization (opening of the artery). Recanalization will be measured with Thrombolysis in Myocardial Infarction (TIMI) score change from baseline angiography to 36 hour angiography. TIMI is cored per published definition.~Additional data for secondary analyses were not acquired to permit analyses."|36 hours|Recanalization at 36 hours|||Participants|||Count of Participants
2637712|NCT01778751|Secondary|Depressive Symptoms|Change in Patient Health Questionnaire as measured at Baseline, 3 months, 6 months|Baseline, 3m, 6m||||units on a scale||Standard Deviation|Mean
2637713|NCT01778751|Secondary|Self-reported Medication Adherence|Change in Self-Reported Medication- Taking Scale as measured at baseline, 3 months, 6 months|Baseline, 3m, 6m||||participants|||Number
2637714|NCT01778751|Secondary|Diabetes Self Care|Self-Care Inventory-revised as measured at baseline, 3 months, 6 months|Baseline, 3m, 6m||||units on a scale||Standard Deviation|Mean
2637715|NCT01778751|Primary|Diabetes Control|Hemoglobin A1c as measured at baseline, 3m, 6m|Baseline, 3months, 6months||||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2637716|NCT01778634|Other Pre-specified|Number of Participants With Cardiac Arrhythmia|EKG evidence of prolonged QT (QTc > 450 ms)|3 days||||Participants|||Count of Participants
2637717|NCT01778634|Other Pre-specified|Number of Participants With Patent Ductus Arteriosus (PDA)|Detection of PDA by cardiac echocardiogram with left to right shunting, or clinical evidence of murmur, bounding pulses, and widened pulse pressure.|14 days|Participants who did not have PDA at baseline (prior to randomization). Participants with PDA at baseline were excluded from analysis (5 placebo and 5 azithromycin.|||Participants|||Count of Participants
2637718|NCT01778634|Other Pre-specified|Number of Participants With Periventricular Leukomalacia (PVL)|The number of subjects with cranial ultrasound confirmed PVL|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks||||Participants|||Count of Participants
2637719|NCT01778634|Other Pre-specified|Number of Participants With Severe Intraventicular Hemorrhage (IVH)|Grade III or IV IVH confirmed by cranial ultrasound|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks|The participants who had a Grade III or IV IVH at baseline (prior to randomization) were excluded (2 placebo and 4 Azithromycin).|||Participants|||Count of Participants
2637720|NCT01778634|Other Pre-specified|Number of Participants With Infections During the NICU Hospitalization|Culture-confirmed bacterial or fungal infection based on culture from sterile site (blood, cerebral spinal fluid, or urine)|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks||||Participants|||Count of Participants
2637721|NCT01778634|Other Pre-specified|Number of Participants With Necrotizing Enterocolitis (NEC)|Necrotizing enterocolitis ≥ Bell Stage II by radiographic and clinical criteria.|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks||||Participants|||Count of Participants
2637722|NCT01778634|Other Pre-specified|Number of Participants With Threshold Retinopathy of Prematurity (ROP)|Threshold ROP requiring surgical intervention as diagnosed by ophthalmologic examination|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks|The number of participants who survived to receive at least 1 eye exam for retinopathy of prematurity|||Participants|||Count of Participants
2637723|NCT01778634|Secondary|Pharmacokinetics (PK)/Pharmacodynamics (PD) Modelling of Time Course of Azithromycin Plasma Concentrations|Number of serum azithromycin concentrations that fell outside the 90% prediction interval determined by 200 simulated replicates based on the population PK of azithromycin in preterm infants.|Study day 1-day 7|No plasma samples from placebo group were analyzed for azithromycin concentrations|||serum conc outside predicted interval|number of serum samples concentrations||Number
2637724|NCT01778634|Secondary|Number of Participants Who Received Non-Study Antibiotics|Received Non-study antibiotics following study drug intervention period.|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks||||Participants|||Count of Participants
2637725|NCT01778634|Secondary|Number of Participants Who Received Postnatal Steroids|Receipt of steroid medications (hydrocortisone, dexamethasone)|36 weeks||||Participants|||Count of Participants
2637726|NCT01778634|Secondary|Number of Participants Who Experienced Air Leaks|Any pulmonary air leak (pulmonary interstitial emphysema, pneumothorax, pneumomediastinum) confirmed by chest x-ray|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks|The participants who had air leak at baseline (prior to randomization) were excluded from analysis (3 placebo and 5 azithromycin).|||Participants|||Count of Participants
2637727|NCT01778634|Secondary|Duration of Oxygen Supplementation|Receipt of supplemental oxygen|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks||||days||Inter-Quartile Range|Median
2637728|NCT01778634|Secondary|Duration of Positive Pressure Support|Combined number of days receiving mechanical ventilation plus non-invasive modes of positive pressure support.|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks||||days||Inter-Quartile Range|Median
2637729|NCT01778634|Secondary|Number of Participants Who Died|Mortality from any cause|22-26 months||||Participants|||Count of Participants
2637730|NCT01778634|Secondary|Number of Participants With Pulmonary Impairment|Parent report of recurrent wheezing and/or chronic cough|6-26 months||2020-09-30|09/2020||||
2637731|NCT01778634|Secondary|Number of Participants With Death or Neurodevelopmental Impairment|Neurodevelopmental impairment will be assigned if any of the following are present at 22-26 months adjusted age: moderate to severe cerebral palsy, bilateral blindness, bilateral hearing impairment requiring amplification, Gross Motor Function Classification System score ≥ 2, or Bayley Scale of Infant and Toddler Development, 3rd edition (BSID-III) cognitive or motor score <70.|22-26 months||2020-01-31|01/2020||||
2637788|NCT01777945|Secondary|Clinical Benefit Rate|The percentage of participants with an overall response (complete or partial remission) or with stable disease.|approximately 2 years||||percentage of participants|||Number
2637732|NCT01778634|Secondary|Number of Participants Who Survived Until 36 Wks Postmenstrual Age That Were Diagnosed With Physiologic Defined Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post Menstrual Age|Physiologic definition of BPD based on oxygen-saturation monitoring|36 weeks post menstrual age (one month prior to due date)|Participants who survived until assessment timepoint 36 weeks post menstrual age (1 month before due date)|||Participants|||Count of Participants
2637733|NCT01778634|Primary|Number of Participants With Survival And Transfer From NICU With Microbiological Eradication of Ureaplasma|Bacterial clearance (eradication) will be defined as 3 negative cultures obtained 2 and 5 days post-third dose and 21 d of age. Survival is defined as survival at time of discharge or transfer from the neonatal intensive care unit (NICU).|Participants will be followed for the duration of hospital stay, an expected average of 10 weeks||||Participants|||Count of Participants
2637734|NCT01778556|Secondary|Endogenous Rate of Appearance of Palmitate|Endogenous Rate of Appearance of Palmitate is measured in plasma.|Intervention 1 (5 days), Intervention 2 (14 days), and Long-term follow-up (6 months)|Measurements were not available.|||μmol/kg fat-free mass/min||Standard Deviation|Mean
2637735|NCT01778556|Secondary|Insulin-mediated Suppression of Hepatic Glucose Production|Hepatic insulin sensitivity (measured as suppression of endogenous glucose production during a hyperinsulinemic, euglycemic clamp)|Intervention 1 (5 days), Intervention 2 (14 days), and Long-term follow-up (6 months)|Measurements were not available.|||percentage||Standard Deviation|Mean
2637736|NCT01778556|Primary|Total Body Insulin Sensitivity|Total body insulin sensitivity (measured as glucose disposal rate during a hyperinsulinemic, euglycemic clamp)|Intervention 1 (5 days), Intervention 2 (14 days), and Long-term follow-up (6 months)|One patient at Period 2 (14 days) in Leptin naive arm was withdrew due to protocol violation.|||mg/kg fat-free mass/min||Standard Deviation|Mean
2637737|NCT01778530|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For details, see the adverse event module.|5 months, 28 days||||participants|||Number
2637738|NCT01778530|Primary|Radiographic Response Rate for Patients With Recurrent Glioblastoma Multiforme (GBM) Treated With TRC105.|Response and progression will be evaluated by the Updated Response Assessment Criteria for High-Grade Gliomas developed by the Response Assessment in Neuro-Oncology Working Group (RANO). Complete response is complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks. Partial response is >/=50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks. Stable disease does not qualify for complete response, partial response, or progression. Progression is a >/=25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids,|14 months|This outcome measure was not met due to termination of the study for poor accrual.||||||
2637739|NCT01778426|Secondary|Return to Work|Percentage of subjects being invalid at inclusion and active at 1 and 2 years.|1 and 2 years|ITT – completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed.|||Percentage of subjects|||Number
2637740|NCT01778426|Secondary|Patient Satisfaction|"Percentage of primo-implanted subjects satisfied with the treatment 1 and 2 years after implantation (defined as indicating pain relief improvement, daily life improvement, rather satisfied with the treatment, or would agree to the treatment again)."|1 and 2 years|ITT – completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed.|||Percentage of subjects satisfied||95% Confidence Interval|Number
2637741|NCT01778426|Secondary|Dose of Analgesics Level 3 (Morphinics)|Dose of analgesics level 3 (morphinics) summarized as equivalent morphine dose at baseline, 1 and 2 years.|Baseline, 1 and 2 years|"ITT – completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed.~Here, patients taking analgesics level 3 medications were considered."|||Daily equivalent morphine dose in mg||Standard Deviation|Mean
2637742|NCT01778426|Secondary|Concomitant Pain Relief Medication|Percentage of primo-implanted subjects taking pain relief medication at baseline, 1 and 2 years.|Baseline, 1 and 2 years|ITT – completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed.|||Percentage of subject taking drug||95% Confidence Interval|Number
2637743|NCT01778426|Secondary|Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 1 Year|Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to one year follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible).|1 year|ITT – completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed.|||Percentage of responders||95% Confidence Interval|Number
2637744|NCT01778426|Secondary|Percentage of Subjects With at Least 50% Pain Relief in the Area of Non-predominant Pain|Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with non-predominant pain intensity at 1 and 2 years follow-up, compared to baseline. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible).|1 year and 2 years|ITT – completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed.|||Percentage of responders||95% Confidence Interval|Number
2637745|NCT01778426|Primary|Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years|Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to two years follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible).|2 years|ITT – completer (n=198) consists of all primo-implant subjects with baseline and follow-up pain intensity data at 2 years completed. Among 198 subjects, 179 patients had a visit at one year completed.|||Percentage of responders||95% Confidence Interval|Number
2637746|NCT01778296|Secondary|Cold Intolerance|We access the cold intolerance of the injured and donor fingers using the self-administered Cold Intolerance Severity Score questionnaire10 that is rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100).|18 months to 24 months|||||||
2637747|NCT01778296|Primary|Discriminatory Sensation of the Flap|Discriminatory sensation of the flap is evaluated with the Static 2-point Discrimination Test. The test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm. The test point is at the center of the flap. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stop at 4mm as a limit of 2PD and considered this normal. These assessments take place at a single time point at the final follow-up.|18 months to 24 months||||mm||Standard Deviation|Mean
2637748|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 60 Degrees/Second|The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength at 60 degrees per second (Newton meters) was compared between groups.|Baseline and 24 weeks||||Nm/kg||Standard Deviation|Mean
2637749|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Dorsiflexion at 30 Degrees/Second|The differences from baseline to 24-weeks in mean changes in ankle dorsiflexion strength 30 degrees per second (Newton meters) was compared between groups.|Baseline and 24 weeks||||Nm/kg||Standard Deviation|Mean
2637750|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 180 Degrees/Second|The difference from baseline to 24-weeks in mean changes in knee extension strength at 180 degrees per second (Newton meters) was compared between groups|Baseline and 24 weeks||||Nm/kg||Standard Deviation|Mean
2637751|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 120 Degrees/Second|The difference from baseline to 24-weeks in mean changes in knee extension strength 120 degrees per second (Newton meters) was compared between groups.|Baseline and 24 weeks||||Nm/kg||Standard Deviation|Mean
2637752|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Quadriceps at 60 Degrees/Second|The difference from baseline to 24-weeks in mean changes in knee extension strength 60 degrees per second (Newton meters) was compared between groups.|Baseline and 24 weeks||||Newton meters (Nm)/kg||Standard Deviation|Mean
2637753|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Pushup|The number of push-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.|Baseline and 24 weeks||||Pushups||Standard Deviation|Mean
2637754|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Sit-up|The number of sit-ups completed in 30 seconds was assessed, and the differences from baseline to 24-weeks in mean changes on the strength subtests of the Bruininks-Oseretsky Test of Motor Proficiency were compared between groups.|Baseline and 24 weeks||||Sit-ups||Standard Deviation|Mean
2637755|NCT01778127|Secondary|Differences in Change in Muscular Strength Between Groups Over 24 Weeks: Hand Grip|The difference from baseline to 24-weeks in mean changes in grip strength (kilograms) was compared between groups.|Baseline and 24 weeks||||kg||Standard Deviation|Mean
2637756|NCT01778127|Secondary|Differences in Change in Flexibility Between Groups Over 24 Weeks: Active Dorsiflexion|The difference between mean changes from baseline to 24-weeks in active dorsiflexion was compared between groups.|Baseline and 24 weeks||||degrees||Standard Deviation|Mean
2637757|NCT01778127|Secondary|Differences in Change in Flexibility Between Groups Over 24 Weeks: Sit and Reach|The difference in mean changes of sit and reach from baseline to 24-weeks was compared between groups|Baseline and 24 weeks||||cm||Standard Deviation|Mean
2637758|NCT01778127|Secondary|Differences in Change in Cardiovascular Function Between Groups Over 24 Weeks|The difference in mean change in peak oxygen uptake from baseline to 24-weeks was compared between groups.|Baseline and 24 weeks||||ml/kg/min||Standard Deviation|Mean
2637759|NCT01778127|Primary|Differences in Change in Daily Average of Moderate and Vigorous Physical Activity (MVPA) Levels Between Groups|The impact of the intervention was assessed at the end of 24 weeks by comparing the mean difference in physical activity levels from baseline to 24-weeks between groups.|Baseline, Week 24||||minutes||Standard Deviation|Mean
2637760|NCT01778062|Secondary|Incidence of COPD Exacerbation|Number of COPD exacerbation during 8-week treatment. COPD exacerbations are defined as a new onset or worsening of at least one respiratory symptom (i.e. dyspnea, cough, sputum purulence or volume, or wheeze) present for at least 3 consecutive days, documented change or increase in COPD-related treatment due to worsening symptoms or documented COPD-related hospitalizations or emergency room visits.|8 week|ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug|||Participants|||Number
2637761|NCT01778062|Secondary|Change From Baseline in Transition Dyspnea Index (TDI) After 8 Weeks of Treatment|TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to 1 hour post inhalation of ipratropium as covariates.|8 week|ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug.|||Score on a scale||Standard Deviation|Mean
2637789|NCT01777945|Secondary|Overall Response Rate|The percentage of participants with complete or partial remission, based on evaluation of tumor responses assessed at regular examinations per routine clinical practice.|approximately 2 years||||percentage of participants|||Number
2637790|NCT01777945|Secondary|Time to Treatment Failure|The time from enrollment to discontinuation of any drug of the treatment combination.|approximately 2 years||||months||Standard Deviation|Mean
2637762|NCT01778062|Secondary|St. George Respiratory Questionnaire for COPD (SGRQ-C) Change After 8 Weeks of Treatment|"The SGRQ-C contains 14 questions divided into two components. Part 1 produces Symptoms scores and Part 2 Activity and Impacts scores. 14 questions which are divided in three domains: symptom (question 1-7), activity (question 9, 12) and impact (question 8, 10, 11, 13 and 14). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Mixed model used baseline SGRQ, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates."|8 week|ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug.|||Score on a scale||Standard Deviation|Mean
2637763|NCT01778062|Primary|Trough Forced Expiratory Volume in One Second Change|Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariate|8 week|ITT (intent to treat) population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug.|||Liters||Standard Deviation|Mean
2637764|NCT01778049|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at 24 Weeks.|Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication, i.e. FPG change from baseline at Week 24.|Baseline and 24 weeks|FAS (OC)|||mmol/L||Standard Error|Least Squares Mean
2637765|NCT01778049|Primary|Change From Baseline of HbA1c After 24 Weeks of Treatment.|"Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication, i.e. HbA1c change from baseline at Week 24. The term baseline was not used to refer to measurements prior to the administration of open-label medication. Such measurements were referred to as pre-treatment. Analyses of change from pre-treatment used the last value before first administration of open-label medication as point of reference.~Observed Case (OC): This method analyse only available data that were observed while patients were on treatment, i.e., excluding the missing data. All values measured after rescue medication taken were set to missing. Full Analysis Set (FAS): Includes all patients in the Treated set who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial."|Baseline and 24 weeks|FAS (OC)|||Percentage of HbA1c||Standard Error|Least Squares Mean
2637766|NCT01778023|Secondary|Ht-V (Height Velocity)|Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Three sort of Ht-V was calculated from height data at Visit 2 (day 0), 4 (6 months ± 7 days) and 6 (12 months ± 7 days), as follows: Between Visits 2 and 4, between Visit 4 and 6 and between Visit 2 and 6. Ht-V was calculated by Novo Nordisk. It is the difference between Ht-V for the last 6 months and Ht-V for the first 6 months of treatment. This endpoint was only evaluated for Group A as per the trial protocol.|At the first 6 months and the last 6 months in group A|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B.|||cm/year||95% Confidence Interval|Least Squares Mean
2637767|NCT01778023|Secondary|Occurrence of Adverse Events|AEs were collected throughout the trial in both groups.|Throughout the trial (12 months)|Safety analysis set – includes all subjects in Group A receiving at least one dose of the trial product and all subjects in Group B who had any available data after Visit 2.|||events|||Number
2637768|NCT01778023|Secondary|Change in Bone Age|Change in bone age from the baseline to 6 months.|After 6 months of treatment.|Safety analysis set (SAS) :includes all subjects in Group A receiving at least one dose of the trial product and all subjects in Group B who had any available data after Visit 2.|||years||Standard Deviation|Mean
2637769|NCT01778023|Secondary|Change in IGF Related Factors: IGFBP-3 (Insulin-like Growth Factor Binding Protein-3)|IGFBP-3 was measured at Visit 1(screening), Visit 3 (3 months ± 7 days ), Visit 4 (6 months ± 7 days), 5 (9 months ± 7 days ) and 6 ( 12 months ± 7 days). Change of IGFBP-3 from baseline to 6 months treatment were calculated.|After 6 months of treatment.|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B.|||mcg/mL||Standard Error|Least Squares Mean
2637770|NCT01778023|Secondary|Change in IGF Related Factors: IGF-I (Insulin-like Growth Factor-I)|IGF-I (insulin-like growth factor-1) was measured at Visit 1 (screening),Visit 3 (3 months ± 7 days ),Visit 4 (6 months ± 7 days),Visit 5 (9 months ± 7 days ) and Visit 6 (12 months ± 7 days ). Change of IGF-I from baseline to 6 months treatment was calculated.|After 6 months of treatment.|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B.|||ng/ml||Standard Error|Least Squares Mean
2637771|NCT01778023|Secondary|Change in Ht-SDS (Height Standard Deviation Score)|Height standard deviation scores (HSDS) were calculated using Korean growth data (reported by the Korea Centre for Disease Control and Prevention). The mean normal range for HSDS is from -2 to +2. Negative scores below -2 indicate a height below normal range, whereas positive scores above +2 indicate a height above normal.|After 6 months of treatment.|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B. Four (4) subjects had missing height at baseline visit.|||Standard Deviation Score (SDS)||Standard Error|Least Squares Mean
2637772|NCT01778023|Primary|Height Velocity (Ht-V)|Height velocity (Ht-V) (cm/year) is the change in height per year (after 6 months of treatment). Ht-V was calculated by Novo Nordisk.|After 6 months of treatment|Full analysis set (FAS) – included all randomised subjects in Group A who received at least one dose of the trial product and all randomised subjects in Group B. Four (4) subjects had missing height at baseline visit.|||cm/year||Standard Error|Least Squares Mean
2637773|NCT01778010|Secondary|Heart Rate|Values for heart rate as a function of cocaine dose and modafinil maintenance condition.|48 days|Eight patients participated in each condition in a within-subjects fashion.|||BPM||Standard Error|Mean
2637791|NCT01777945|Primary|Progression-free Survival (PFS)|The time from enrollment until disease progression, assessed as the time to tumor progression, as evaluated by regular examinations per routine clinical practice, or death from any cause.|approximately 2 years||||months||Standard Deviation|Median
2637774|NCT01778010|Secondary|Drug Quality Cluster|"Visual analogue scale ratings on the 'Drug Quality' cluster as a function of cocaine dose and modafinil maintenance condition. A cluster score was derived by taking the arithmetic average of the items in the cluster. Scores range from 0-100, with higher scores indicating greater agreement with the term. The Drug Quality Cluster consisted of three items:~the choice was of high quality~the choice was potent~I liked the choice Higher scores indicate increasing agreement with the statement, which would indicate a poorer outcome."|48 days|Eight subjects participants in each condition in a within-subjects fashion.|||units on a scale||Standard Error|Mean
2637775|NCT01778010|Primary|Cocaine Self-administration|The number of purchased cocaine doses as a function of cocaine dose and modafinil maintenance condition.|48 days|Eight patients contributed to each condition, in a within-subjects manner.|||Number of doses purchased||Standard Error|Mean
2637776|NCT01777997|Secondary|Number of Subjects Who Experience Grade 3 or 4 Signs and Symptoms or Laboratory Abnormalities, Diagnoses (Any Grade), or Other Serious Adverse Events (SAEs)|Grading uses the Division of AIDS (DAIDS) 2004 (clarification 2009) Severity of Adverse Events Table, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life-threatening.|From initiation of treatment to study completion at week 60 or 108 or premature study discontinuation|All participants who initiated ART, regardless of ART status at time of event|||participants|||Number
2637777|NCT01777997|Secondary|Change in Quality of Life (QoL) Index|"QoL index was obtained by averaging the five responses on the Euro-Quality of Life questionnaire (EQ-5D), where a response of 0 indicates no problems/no discomfort, 1 indicates some problems/moderate discomfort and 2 indicates unable to perform activities/extreme discomfort. Change equals each specific week index, respectively, minus the baseline index (mean of the two averages obtained prior to the start of ART)"|From baseline (pre-ART and week 0 on ART) to weeks 4, 24 and 48 on ART|As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA <200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.|||units on a scale||Inter-Quartile Range|Median
2637778|NCT01777997|Secondary|Change in Levels of D-dimer|Change equals each specific week result, respectively, minus the baseline result (mean of the two log10-transformed measurements obtained prior to the start of ART)|From baseline (pre-ART and week 0 on ART) to weeks 4, 24 and 48 on ART|As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA <200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.|||log10(ng/mL)||Inter-Quartile Range|Median
2637779|NCT01777997|Secondary|Change in Levels of Interleukin (IL)-6|Change equals each specific week result, respectively, minus the baseline result (mean of the two log10-transformed measurements obtained prior to the start of ART)|From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART|As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA <200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.|||log10(pg/mL)||Inter-Quartile Range|Median
2637780|NCT01777997|Secondary|Change in Levels of CD4+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+)|Change equals each specific week percentage, respectively, minus the baseline percentage (mean of the two measurements obtained prior to the start of ART)|From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART|As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA <200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.|||% of CD4+ T-cells||Inter-Quartile Range|Median
2637781|NCT01777997|Secondary|Change in Levels of CD8+ T-cell Activation|Change equals each specific week percentage, respectively, minus the baseline percentage (mean of the two measurements obtained prior to the start of ART)|From baseline (pre-ART and week 0 on ART) to weeks 4, 12, 24 and 48 on ART|As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA <200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.|||% of CD8+ T-cells||Inter-Quartile Range|Median
2637782|NCT01777997|Secondary|Change in CD4+ T-cell Count|Change equals each specific week CD4+ T-cell count, respectively, minus the baseline CD4+ T-cell count (mean of the two measurements obtained prior to the start of ART)|From baseline (pre-ART and week 0 on ART) to weeks 12, 24, 36 and 48 on ART|As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA <200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.|||cells/mm^3||Inter-Quartile Range|Median
2637783|NCT01777997|Secondary|Plasma HIV-1 RNA Level Measured by Single Copy Assay Using Primer in Integrase (iSCA) as the Proportion of Participants Below the Limit of the Assay|At a specific week, the proportion of participants with HIV-1 RNA by iSCA less than assay limit of detection (0.6 copies/mL)|At pre-ART and weeks 0, 4, 12, 24, 36 and 48 on ART|As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA <200 copies/mL for at least 2 weeks (14 days) prior to measured weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.|||proportion of participants|||Number
2637784|NCT01777997|Primary|Change in Levels of CD8+ T-cell Activation (Defined as the Percentage HLA-DR+/CD38+) From Baseline to Weeks 24 and 48 on ART|Mean change from baseline (pre-ART [study entry] and week 0 on ART [study week 12]), estimated with a repeated measures analysis (jointly to weeks 24 and 48 on ART) using generalized estimating equations (GEE)|From baseline (pre-ART and week 0 on ART) to weeks 24 and 48 on ART|As-treated: Only participants with results while receiving intervention (ART) and suppressed HIV-1 RNA <200 copies/mL for at least 2 weeks (14 days) prior to week 24 or 48 weeks on ART (and without use of prohibited or precautionary medications based on team review of concomitant medications) were included.|||% of CD8+ T-cells||95% Confidence Interval|Mean
2637785|NCT01777945|Secondary|Number of Participants With Adverse Events||approximately 2 years|46 participants enrolled in the study were evaluable with regards to tolerability; however, 1 participant did not meet the eligibility criteria, was excluded from the efficacy analyses, but was included in the safety analyses.|||participants|||Number
2637793|NCT01777932|Secondary|Participants With Type of Metastases at Study Entry (Baseline)|The type of metastases (bone and visceral) are reported at study entry (baseline) is reported.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.|||participants|||Number
2637794|NCT01777932|Secondary|Participants With Disease History at Study Entry (Baseline)|Participant's history at the time of diagnosis of metastatic disease and sites of metastases is reported at study entry (baseline).|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.|||participants|||Number
2637795|NCT01777932|Secondary|Participants With Prior Therapy at Study Entry (Baseline)|The status of prior therapy (i.e. chemotherapy, endocrine therapy, and radiotherapy) at study entry (baseline) is reported.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure|||participants|||Number
2637796|NCT01777932|Secondary|Participants With Eastern Cooperative Oncology Group Status at Study Entry|The Eastern Cooperative Oncology Group (ECOG) status for participants was categorized as 0, 1, 2, or missing. ECOG has 4 grades as: 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care, totally confined to bed/chair.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.|||participants|||Number
2637797|NCT01777932|Secondary|Participants With Tumor Stage at Diagnosis|Number of participants at each Metastatic breast cancer stage 0, I, II, III or IV, at the point of diagnosis is reported.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.|||participants|||Number
2637798|NCT01777932|Secondary|Progression Free Survival in Participants With Triple Negative Receptor Status at Study Entry|PFS was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment for participants with triple negative status and not triple negative status.|Approximately 5 years|All enrolled participants were considered for this outcome measure. Out of the total 220 enrolled participants, 106 participants were triple negative, 110 were not triple negative and data for 4 participants were missing.|||months||95% Confidence Interval|Median
2637799|NCT01777932|Secondary|Participants With Hormone Receptor Status at Diagnosis|The hormone receptor status for Oestrogen (ER), Progesterone (PgR) and Human epidermal growth factor receptor (HER-2) is reported as positive, negative, unknown or missing.|Baseline (Day 1)|All enrolled participants were considered for this outcome measure.|||participants|||Number
2637800|NCT01777932|Secondary|Time to Discontinuation (TTD) of Bevacizumab Treatment|Time to treatment discontinuation is defined as the time to change of therapy due to any cause (tumour progression, toxicity, or other causes) from the start of bevacizumab treatment.|Approximately 5 years|All enrolled participants were considered for this outcome measure.|||months||95% Confidence Interval|Median
2637801|NCT01777932|Secondary|One Year Survival|The status of participants whether alive, dead, unknown or missing one year after the start of bevacizumab treatment is reported.|Approximately 5 years|All enrolled participants were considered for this outcome measure.|||participants|||Number
2637802|NCT01777932|Primary|Progression Free Survival|Progression free survival (PFS) was assessed based on time to tumour progression or death (whichever occurred first) from the start of bevacizumab treatment.|Approximately 5 years|All enrolled participants were considered for this outcome measure.|||months||95% Confidence Interval|Median
2637803|NCT01777854|Primary|Pain After Tonsillectomy|A questionnaire will be given to patients. Patients are asked to describe their pain and oral intake on post op days 0,1,3,5,7,10 and 14. This should take less than one minute per assessment day. At the end of the survey, they are asked to comment on any postoperative problems such as hemorrhage or dehydration. This should take less than 5 minutes. Parents will be asked to assist the child in completing the survey. They will be asked to turn in the form on the postoperative follow up visit (14-21 days after surgery) or mail it in to the principal investigator if the surgeon does not have a postoperative follow up visit. For these patients, an addressed and stamped envelope will be provided.|2 weeks|The patients did not receive the intervention||||||
2637804|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: Racc|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.||||||
2637805|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: Tmax|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.||||||
2637806|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: Cmax|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.||||||
2637807|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: Cmin|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.||||||
2637808|NCT01777776|Secondary|Phase Ib/II - Pharmacokinetic Parameters: AUCtau|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to pharmacokinetic parameters were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.||||||
2638217|NCT01775670|Secondary|Thumb MCP in Pinch Position (Degrees)|Measurements of thumb MCP in pinch position.|At Enrollment|The measurement of the thumb MCP joint in a pinch position was the same, 10 degrees, for the 2 subjects in the OT splint group, therefore the standard deviation is 0.|||degrees||Standard Deviation|Mean
2637809|NCT01777776|Secondary|Phase II - Overall Survival (OS)|"OS is defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last known date patient alive.~Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.||||||
2637810|NCT01777776|Secondary|Phase Ib/II - Duration Of Response (DOR)|"DOR is calculated as the time from the date of first documented response (complete response (CR) or partial response (PR)) to the first documented date of progression or death due to underlying cancer.~Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.||||||
2637811|NCT01777776|Secondary|Phase Ib/II - Progression Free Survival (PFS)|"PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause.~Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.||||||
2637812|NCT01777776|Secondary|Phase Ib/II - Overall Response Rate (ORR)|"ORR is defined as the proportion of patients with a best overall response of complete response or partial response.~Due to the halt of enrollment during the Phase Ib part of the study, this analysis was not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.||||||
2637813|NCT01777776|Secondary|Phase Ib/II - Plasma Concentration-time Profiles|Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to plasma concentration time profiles were not performed.|28-day cycles|This analysis group would have been the PK analysis set (PAS), which would have consisted of all patients who had at least one blood sample providing evaluable drug concentration data.||||||
2637814|NCT01777776|Secondary|Phase I - Number of Subjects Experiencing at Least One Serious Adverse Event (SAE).||Approximately 23 months after enrollment|Analysis group is comprised of the Safety Set (SS), which is all patients who received at least one dose of LEE011 or LGX818, and have at least one valid post-baseline safety assessment.|||participants|||Number
2637815|NCT01777776|Secondary|Phase I - Number of Subjects Experiencing at Least One Adverse Event (AE).||Approximately 23 months after enrollment|Analysis group is comprised of the Safety Set (SS), which includes all patients who received at least one dose of LEE011 or LGX818, and have at least one valid post-baseline safety assessment.|||participants|||Number
2637816|NCT01777776|Primary|Phase II - Objective Response Rate (ORR)|"As per RECIST v1.1, ORR is defined as the proportion of patients with a best overall response of complete response or partial response.~Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to efficacy were not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.||||||
2637817|NCT01777776|Primary|Phase II - Progression Free Survival (PFS)|"As per RECIST v1.1, PFS is the time from date of randomization/ start of treatment to the date of event defined as the first documented progression or death due to any cause.~Due to the halt of enrollment during the Phase Ib part of the study, all analyses related to efficacy were not performed."|Approximately 23 months after enrollment|This analysis set would have been the Full Analysis (FAS), which included all patients who received at least one dose of encorafenib or ribociclib.||||||
2637818|NCT01777776|Primary|Phase Ib - Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1|"Dose Limiting Toxicities (DLTs) during the first 28 days of the combination treatment of LEE011 and LGX818.~Due to the halt of enrollment, no Maximum Tolerated Dose (MTD) was formally declared during the study."|Cycle 1 (approximately 28 days)|Analysis group is comprised of the Safety Set (SS), which includes all patients who received at least one dose of LEE011 or LGX818, and have at least one valid post-baseline safety assessment.|||participants with DLTs|||Number
2637819|NCT01777763|Other Pre-specified|Number of Participants Discontinuing Study Treatment Due to an AE|AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. These AEs resulted in participants stopping study drug treatment. This measure includes participants who discontinued due to AEs and also includes treatment failures that were attributed to AEs.|Up to Day 28|The safety population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
2637820|NCT01777763|Other Pre-specified|Number of Participants With Treatment-Related AEs|AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. Treatment-related AEs were considered by the investigator to be related to the study drug.|Up to Day 65|The safety population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
2637821|NCT01777763|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs)|AEs are any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not considered related to this study drug. Treatment-emergent AEs are any events not present before starting study drug treatment or any events that were present before treatment that worsened in either intensity or frequency after exposure to study drug.|Up to Day 65|The safety population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
2637822|NCT01777763|Other Pre-specified|Number of Participants Surviving at Day 65|Number of Participants Alive at Day 65|Day 65|The safety population consisted of all participants who received at least one dose of study drug.|||Participants|||Number
2637844|NCT01777581|Primary|Visual Analogue Scale Score Referring to Radicular Pain (VAS-rad)|The primary outcome is change in pain VAS from baseline through 10 weeks. The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm with 0 being absence of pain or no pain noted and 100 being worst imaginable pain/as bad as can be. The higher the score the greater the over all pain intensity. Mean cumulative total scores were reported.|baseline and 10 weeks||||units on a scale||Standard Deviation|Mean
2637823|NCT01777763|Primary|Apparent Total Body Clearance (CL/F) for Posaconazole Tablet|Blood samples for the assessment of CL/F, the rate at which posaconazole was removed from the body, were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose.|Predose on Day 1 up to 24 hours postdose on Day 8|The CL/F PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through predose on the Day 8 steady-state visit.|||L/hr||Standard Deviation|Mean
2637824|NCT01777763|Primary|Time to Maximum Concentration (Tmax) of Posaconazole Tablet|Blood samples for the assessment of Tmax were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose.|Predose on Day 1 up to 24 hours postdose on Day 8|The Tmax PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.|||Hours||Full Range|Median
2637825|NCT01777763|Primary|Maximum Concentration (Cmax) of Posaconazole Tablet|Blood samples for the assessment of Cmax were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose.|Predose on Day 1 up to 24 hours postdose on Day 8|The Cmax PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.|||ng/mL||Standard Deviation|Mean
2637826|NCT01777763|Primary|Minimum Concentration (Cmin) of Posaconazole Tablet|Cmin was defined as posaconazole trough level immediately before a participant received the dose of posaconazole tablets on the specified day. Trough (Cmin) level blood samples for determination of posaconazole in plasma were collected for all participants on Day 1, Day 2, Day 3, and Day 8. On Day 1, the trough level sample was collected the before the first dose of study drug. On Day 2, trough samples were collected approximately 12 hours after the second dose of study drug was administered on Day 1. On all subsequent days, trough samples were collected approximately 24 hours following the previous day's dose of study drug.|Predose on Day 1 up to 24 hours postdose on Day 8|The Cmin PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.|||ng/mL||Standard Deviation|Mean
2637827|NCT01777763|Primary|Average Concentration (Cavg) of Posaconazole Tablet|"Posaconazole steady-state concentrations of posaconazole in the plasma reached after regular and repeated dosing were used to estimate pharmacokinetic (PK) parameters for each participant where Cavg was defined as area under the plasma concentration versus time curve divided by the dosing interval.~Blood samples for the assessment of Cavg were collected on Day 1 and Day 8 predose and then at specified time points up to 24 hours postdose."|Predose on Day 1 up to 24 hours postdose on Day 8|The Cavg PK population included participants who met the inclusion/exclusion criteria, complied with protocol procedures including collection of specified PK and dosing parameters, had no major protocol violations, and had documented adherence to dosing and PK regimens through the Day 8 steady-state visit.|||ng/mL||Standard Deviation|Mean
2637828|NCT01777620|Secondary|Percentage of Participants With at Least a 1-Grade Improvement in the Investigator's Assessment of the Severity of CFL at Maximum Smile Assessed Using the FWS|The Investigator assessed the severity of the patient's CFL at maximum smile using the 4-point FWS where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with at least a 1-Grade improvement from Baseline is reported.|Baseline, Day 30|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
2637829|NCT01777620|Secondary|Percentage of Participants With a Score of None or Mild in the Investigator's Assessment of the Severity of Glabellar Lines at Maximum Frown Assessed Using the FWS|The Investigator assessed the severity of the patient's glabellar lines at maximum frown using the 4-point Facial Wrinkle Scale (FWS) where: 0=none, 1=mild, 2=moderate, and 3=severe. The percentage of participants with a score of none or mild is reported.|Day 30|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
2637830|NCT01777620|Secondary|Percentage of Participants Who Were Likely to Continue Treatment of CFL and Glabellar Lines Assessed Using the FLSQ|Participants assessed how likely they were to continue treatment of CFL and glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported.|Day 90|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
2637831|NCT01777620|Secondary|Percentage of Participants Who Were Likely to Continue Treatment of Glabellar Lines Assessed Using the FLSQ|Participants assessed how likely they were to continue treatment of glabellar Lines using the FLSQ 5-point scale where: 1=Not at all, 2=A little bit, 3=Moderately, 4=Quite a bit and 5=Extremely. The percentage of participants with responses Moderately, Quite a bit and Extremely is reported.|Day 90|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
2637832|NCT01777620|Secondary|Percentage of Participants Where Treatment of CFL and Glabellar Lines Met Expectation Assessed Using the FLSQ|Participants assessed whether treatment of glabellar lines met expectations using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported.|Day 60|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
2637845|NCT01777568|Secondary|Number of Participants With Superficial SSI (Surgical Site Infection)|superficial SSI (Surgical Site Infection)|Postoperative 30 days||||Participants|||Count of Participants
2673272|NCT01462877|Secondary|Change in Serum Alanine Aminotransferase|Blood tests|Baseline up to 8 weeks after intervention|Safety set|||percentage of ALT change||Full Range|Median
2637833|NCT01777620|Secondary|Percentage of Participants Satisfied With Duration of Treatment of CFL and Glabellar Lines Assessed Using the FLSQ|Participants assessed their overall satisfaction with duration of treatment of both CFL and glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported.|Day 90|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
2637834|NCT01777620|Secondary|Percentage of Participants Where Treatment of Glabellar Lines Met Expectation Assessed Using the FLSQ|Participants assessed whether treatment of their glabellar lines met expectation using the FLSQ 3-point scale where: 1=Worse than expected, 2=Met expectations and 3=Better than expected. The percentage of participants with responses Met expectations and Better than expected is reported.|Day 60|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
2637835|NCT01777620|Secondary|Percentage of Participants Satisfied With Duration of Treatment of Glabellar Lines Assessed Using the FLSQ|Participants assessed their overall satisfaction with duration of treatment of glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported.|Day 90|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
2637836|NCT01777620|Secondary|Percentage of Participants Satisfied With Treatment of Crow's Feet Lines (CFL) and Glabellar Lines Assessed Using the FLSQ|Participants assessed their overall satisfaction with both their CFL and glabellar lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants mostly or very satisfied is reported.|Day 60|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
2637837|NCT01777620|Primary|Percentage of Participants Satisfied With Treatment of Glabellar Lines Assessed Using the Facial Line Satisfaction Questionnaire (FLSQ)|Participants assessed their overall satisfaction with their glabellar (frown) lines using the FLSQ 5-point scale where: -2=Very dissatisfied, -1=Mostly dissatisfied, 0=Neither dissatisfied nor satisfied, 1=Mostly satisfied and 2=Very satisfied. The percentage of participants with responses mostly or very satisfied is reported.|Day 60|Per-Protocol population included all randomized participants who received study treatment and had at least one post-baseline efficacy assessment and no major protocol deviations.|||Percentage of participants|||Number
2637838|NCT01777581|Secondary|State-trait Anxiety Inventory (STAI)|"Self-report evaluation of anxiety symptoms.Assessment of subjective symptoms of current anxiety and chronic anxiety.~There are 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: I am tense; I am worried and I feel calm; I feel secure. Trait anxiety items include: I worry too much over something that really doesn't matter and I am content; I am a steady person. All items are rated on a 4-point scale~Scale~1= almost never 4= almost always~Higher scores indicate greater anxiety. Mean cumulative scores were reported"|baseline and 10 weeks||||units on a scale||Standard Deviation|Mean
2637839|NCT01777581|Secondary|Beck Depression Inventory (BDI-II)|"Self-report evaluation of depressive symptoms.The secondary outcome measure is change in Beck Depression Inventory. The scale for this inventory is:~0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. The higher the score the degree of depression."|baseline and 10 weeks||||units on a scale||Standard Deviation|Mean
2637840|NCT01777581|Secondary|Neuropathic Pain Questionnaire|"Self-report evaluation of nerve pain symptoms. A low total cumulative score means less pain and higher cumulative score is greater pain.~Total cumulative scores range form 0 to 1000 where in 0 is absence of pain and 1000 highest pain."|baseline and 10 weeks||||units on a scale||Standard Deviation|Mean
2637841|NCT01777581|Secondary|Oswestry Low Back Pain Disability Questionnaire|"Self report evaluation of various back pain symptoms. For each of 10 sections participants rate pain on a scale of 0-5 in these categories:~Section 1 - Pain intensity~Section 2 - Personal care~Section 3 - Lifting~Section 4 - Walking~Section 5 - Sitting~Section 6 - Standing~Section 7 - Sleeping~Section 8 - Sex life (if applicable)~Section 9 - Social life~Section 10 - Travelling~The scores are combined form each category into overall score. Scores are converted to percentages as follows:~0% to 20%: minimal disability: The patient can cope with most living activities.~21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing.~41%-60%: severe disability: Pain remains the main problem-activities of daily living are affected.~61%-80%: crippled: Back pain impinges on all aspects of life.~81%-100%: Patients are either bed-bound or exaggerating their symptoms"|baseline and 10 weeks||||percent score||Standard Deviation|Mean
2637842|NCT01777581|Secondary|SF-36 (Short Form)|"Self-report of quality of life. Subjective measure of perceived quality of life.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.~Scoring: Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. Higher scores reflect higher quality of life with 100 high life quality. Total mean cumulative scores were reported~The eight sections are:~vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health"|baseline and 10 weeks||||units on a scale||Standard Deviation|Mean
2637843|NCT01777581|Secondary|VAS Related to Nociceptive Pain Component (VAS-Noc)|The secondary outcome is change in pain VAS from baseline through 1o weeks as related to nociceptive pain component. The effect size was calculated using the VAS scores measured on a scale of 0 to 100 mm with 0 being absence of pain or no pain noted and 100 being worst imaginable pain/as bad as can be. The higher the score the greater the over all pain intensity. Mean cumulative scores were reported|baseline and 10 weeks||||units on a scale||Standard Deviation|Mean
2637846|NCT01777568|Primary|Number of Participants With One or More Composite Complications|"A composite of complications:~surgical sites infection (organ space / deep)~Anastomotic leak~Intra-abdominal abscess~Sepsis~Wound dehiscence~Death"|Postoperative 30 days||||Participants|||Count of Participants
2637847|NCT01777542|Secondary|Quantitative Measures of Respiration: Apnea Index|"Respiratory data was collected using non-invasive respiratory inductance plethysmography from a BioCapture® recording device. BioCapture® is a child-friendly measurement device that can record from 1 to 12 physiological signal transducers in a time-locked manner. It can be configured with the pediatric chest and abdominal plethysmography bands and the 3 lead ECG signals we plan to use for monitoring cardiac safety throughout the study. Each transducer is placed on the patient independently to provide a customized fit that yields the highest signal quality for each patient irrespective of body shape and proportion. The transducer signals captured by the BioCapture® are transmitted wirelessly to a laptop computer where all signals are displayed in real-time.~The apnea index is given as apneas/hour. Data on apneas greater than or equal to 10 seconds are displayed below. The higher the frequency of apnea, the more severe the breathing abnormality."|Every 10 weeks during each of the two 20-week treatment periods|"In some cases, the number of participants analyzed is less than 15 for each group due to inability to complete testing session.~One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point."|||Apneas/Hour||Inter-Quartile Range|Median
2637848|NCT01777542|Secondary|Aberrant Behavior Checklist - Community Edition (ABC-C)|"The ABC-C is a global behavior checklist implemented for the measurement of drug and other treatment effects in populations with intellectual disability. Behavior based on 58 items that describe various behavioral problems.~Each item is rated on the parents perceived severity of the behavior. The answer options for each item are:~0 = Not a problem~= Problem but slight in degree~= Moderately serious problem~= Severe in degree~The measure is broken down into the following subscales with individual ranges as follows:~Subscale I (Irritability): 15 items, score range = 0-45 Subscale II (Lethargy): 16 items, score range = 0-48 Subscale III (Stereotypy): 7 items, score range = 0-21 Subscale IV (Hyperactivity): 16 items, score range = 0-48 Subscale V (Inappropriate Speech) was not included in the breakdown because it was not applicable (no participants in the study had verbal language)."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|"In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.~One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point."|||units on a scale||Inter-Quartile Range|Median
2637849|NCT01777542|Secondary|Communication and Symbolic Behavior Scales - Developmental Profile (CSBS-DP)|"The CSBS-DP was designed to measure early communication and symbolic skills in infants and young children (that is, functional communication skills of 6 month to 2 year olds). The CSBS-DP measures skills from three composites: (a) Social (emotion, eye gaze, and communication); (b) Speech (sounds and words); and (c) Symbolic (understanding and object use) and asks about developmental milestones. The data reported are the composite scores for these three categories.~The possible scores for the three composite categories are as follows:~Social Composite = 0-48; Speech Composite = 0-40; Symbolic Composite = 0-51.~A higher score indicates more advanced abilities in that area."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|"In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.~One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point."|||units on a scale||Inter-Quartile Range|Median
2637850|NCT01777542|Secondary|Vineland Adaptive Behavior Scales, Second Edition (VABS-II)|"The VABS-II is a survey designed to assess personal and social functioning. Within each domain (Communication, Daily Living Skills, Socialization, and Motor Skills), items can given a score of 2 if the participant successfully performs the activity usually; a 1 if the participant successfully performs the activity sometimes, or needs reminders; a 0 if the participant never performs the activity, and a DK if the parent/caregiver is unsure of the participant's ability for an item.~The raw scores in each sub-domain are reported and the ranges for these are as follows: [Communication Domain], Receptive Language=0-40, Expressive Language=0-108, Written Language=0-50; [Daily Living Skills Domain], Personal=0-82, Domestic=0-48, Community=0-88; [Socialization Domain], Interpersonal Relationships=0-76, Play and Leisure Time=0-62, Coping Skills=0-60; [Motor Skills Domain]: Gross Motor Skills=0-80, Fine Motor Skills=0-72.~A higher score indicates more advanced abilities."|At the start and end of each 20-week treatment period|"One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point."|||units on a scale||Inter-Quartile Range|Median
2637851|NCT01777542|Secondary|Mullen Scales of Early Learning (MSEL)|"The MSEL is a standardized developmental test for children ages 3 to 68 months consisting of five subscales: gross motor, fine motor, visual reception, expressive language, and receptive language.~The raw score is reported for each subscale domain. The potential score ranges are as follows:~Visual Reception: 33 items, score range=0-50, Fine Motor: 30 items, score range= 0-49, Receptive Language: 33 items, score range= 0-48, Expressive Language: 28 items, score range= 0-50. The gross motor subscale was not included in this population.~A higher raw score indicates more advanced abilities in that section."|At the start and end of each 20-week treatment period|"One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point.~In some cases, the number of participants analyzed is less than 15 for each group due to subject's inability or unwillingness to complete the testing."|||units on a scale||Inter-Quartile Range|Median
2637852|NCT01777542|Secondary|Anxiety, Depression, and Mood Scale (ADAMS)|"Remaining subscales of the ADAMS that are not primary outcome measures include: Manic/hyperactive, Depressed mood, General anxiety, Obsessive/compulsive behavior.~The range for each subscale is as follows:~Manic/Hyperactive Behavior: 0-15 Depressed Mood: 0-21 General Anxiety: 0-21 Obsessive/Compulsive Behavior: 0-9~The higher the score for each subscale, the more problematic the behavior."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|"In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.~One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point."|||units on a scale||Inter-Quartile Range|Median
2638218|NCT01775670|Secondary|Thumb Metacarpophalangeal (MCP) Joint in Resting Position (Degrees)|Measurements of thumb metacarpophalangeal (MCP) joint in resting position.|At Enrollment||||degrees||Standard Deviation|Mean
2637853|NCT01777542|Secondary|Rett Syndrome Behavior Questionnaire (RSBQ)|"The RSBQ is a parent-completed measure of abnormal behaviors typically observed in individuals with RTT. Each item, grouped into eight subscales, is scored on a Likert scale of 0-2, according to how well the item describes the individual's behavior. A score of 0 indicates the described item is not true, a score of 1 indicates the described item is somewhat or sometimes true, and a score of 2 indicates the described item is very true or often true.~The total sum of each subscale is reported. The higher the score, the more severe the symptoms of that subscale in the participant.~The range for each subscale is as follows:~General Mood: 0-16 Body rocking and expressionless face: 0-14 Hand behaviors: 0-12 Breathing Problems: 0-10 Repetitive Face Movements: 0-8 Night-time behaviors: 0-6 Walking Standing: 0-4~The fear/anxiety subscale was used as a primary outcome measure in this study and results can be found in that section."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|"In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.~One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point."|||units on a scale||Inter-Quartile Range|Median
2637854|NCT01777542|Primary|Kerr Clinical Severity Scale|"The Kerr clinical severity scale (Kerr scale) is a quantitative measure of global disease severity. The Kerr scale is a summation of individual items related to Rett syndrome phenotypic characteristics. The items are based on the severity or degree of abnormality of each characteristic on a discrete scale (0, 1, 2) with the highest level corresponding to the most severe or most abnormal presentations.~The possible range of scores is 0-48. The higher the score, the more severe the symptoms."|At the start and end of each 20-week treatment period|"In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.~One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point."|||units on a scale||Inter-Quartile Range|Median
2637855|NCT01777542|Primary|Parent Targeted Visual Analog Scale (PTSVAS) - Scale 3|"The parent or caretaker identifies the three most troublesome, RTT-specific, target symptoms, such as inattention or breath-holding. This allows the problems that are of concern to parents and the family to be targeted in the trial. In this study the caregiver will choose three target symptoms at baseline and then rate changes in severity of each target symptom on a visual analog scale (VAS).~The VAS is a 10 cm line, where a target symptom is anchored on one end with the description the best it has ever been and on the other with the description the worst it has ever been. The parent was asked to marked on the line where they felt their child's symptoms currently fit best. This mark was measured as recorded as a numeric value from 0.00-10.00 cm. The higher the value, the worse the symptom."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.|||units on a scale||Inter-Quartile Range|Median
2637856|NCT01777542|Primary|Parent Targeted Visual Analog Scale (PTSVAS) - Scale 2|"The parent or caretaker identifies the three most troublesome, RTT-specific, target symptoms, such as inattention or breath-holding. This allows the problems that are of concern to parents and the family to be targeted in the trial. In this study the caregiver will choose three target symptoms at baseline and then rate changes in severity of each target symptom on a visual analog scale (VAS).~The VAS is a 10 cm line, where a target symptom is anchored on one end with the description the best it has ever been and on the other with the description the worst it has ever been. The parent was asked to marked on the line where they felt their child's symptoms currently fit best. This mark was measured as recorded as a numeric value from 0.00-10.00 cm. The higher the value, the worse the symptom."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.|||units on a scale||Inter-Quartile Range|Median
2637857|NCT01777542|Primary|Parent Targeted Visual Analog Scale (PTSVAS) - Scale 1|"The parent or caretaker identifies the three most troublesome, RTT-specific, target symptoms, such as inattention or breath-holding. This allows the problems that are of concern to parents and the family to be targeted in the trial. In this study the caregiver will choose three target symptoms at baseline and then rate changes in severity of each target symptom on a visual analog scale (VAS).~The VAS is a 10 cm line, where a target symptom is anchored on one end with the description the best it has ever been and on the other with the description the worst it has ever been. The parent was asked to marked on the line where they felt their child's symptoms currently fit best. This mark was measured as recorded as a numeric value from 0.00-10.00 cm. The higher the value, the worse the symptom."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.|||units on a scale||Inter-Quartile Range|Median
2637858|NCT01777542|Primary|Parental Global Impression - Improvement (PGI-I)|"As part of each visit after the study intervention was initiated, the parent/caregiver was asked to compare the patient's overall clinical condition to the score obtained at the baseline (visit 1) visit. Based on information collected, the clinician determined if any improvement occurred on the following 7-point scale: 1=Very much improved since the initiation of treatment; 2=Much improved; 3=Minimally improved; 4=No change from baseline (the initiation of treatment); 5=Minimally worse; 6=Much worse; 7=Very much worse since the initiation of treatment.~The possible range for reported scores is 1-7."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|"Data was not collected at visit 1 because participants had not yet been exposed to either intervention.~In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms."|||units on a scale||Inter-Quartile Range|Median
2637867|NCT01777490|Primary|Patient Days in the Community (e.g. Days Not in Emergency Department, Inpatient, or Nursing Home Setting)|Days at home is defined as the total numbers of days of VA, inpatient and post-acute facility care subtracted from 365 (or number of days living in 12 month post randomization period if deceased). Mean was estimated using a generalized linear model.|12 months|All enrolled subjects were included in the analysis of the primary outcome, except for the one subject who withdrew permission to use data.|||days||95% Confidence Interval|Mean
2673273|NCT01462877|Secondary|Change in Serum Apolipoprotein B|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set|||percentage of apoB change||Standard Deviation|Mean
2637859|NCT01777542|Primary|Parental Global Impression - Severity (PGI-S)|"The PGI-S is the parent version of the CGI-S. Parents/caregivers/LAR are asked to rate the severity of their child's symptoms at baseline on a 7-point scale from not at all impaired to the most impaired. The parents/caregivers/LAR will complete the PGI-S at each study visit.~The scores that correspond to each possible grouping are as follows:~1=Normal, not at all impaired; 2=Borderline impaired; 3=Mildly impaired; 4=Moderately impaired; 5=Markedly impaired; 6=Severely impaired; 7=The most impaired.~The possible range for reported scores is 1-7."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.|||units on a scale||Inter-Quartile Range|Median
2637860|NCT01777542|Primary|Clinical Global Impression - Improvement (CGI-I)|"Each time the patient was seen after the study intervention was initiated, the clinician compared the patient's overall clinical condition to the CGI-S score obtained at the baseline (visit 1) visit. Based on information collected, the clinician determined if any improvement occurred on the following 7-point scale: 1=Very much improved since the initiation of treatment; 2=Much improved; 3=Minimally improved; 4=No change from baseline (the initiation of treatment); 5=Minimally worse; 6=Much worse; 7=Very much worse since the initiation of treatment.~The possible range for reported scores is 1-7."|Every 10 weeks during each of the two 20-week treatment periods|"Data was not collected at Visit 1 because participants had not yet been exposed to either intervention.~One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point."|||units on a scale||Inter-Quartile Range|Median
2637861|NCT01777542|Primary|Clinical Global Impression - Severity (CGI-S)|"This scale is used to judge the severity of the subject's disease prior to entry into the study. The clinician will rate the severity of behavioral symptoms at baseline on a 7-point scale from not impaired to the most impaired.~The scores that correspond to each possible grouping are as follows: 1=Normal, not at all impaired; 2=Borderline impaired; 3=Mildly impaired; 4=Moderately impaired; 5=Markedly impaired; 6=Severely impaired; 7=The most impaired.~The possible range for reported scores is 1-7."|Every 10 weeks during each of the two 20-week treatment periods|"One participant from the rhIGF-1 First, Then Placebo group was removed from the study prior to Visit 10, so there is only data for 14 participants included at that time point."|||units on a scale||Inter-Quartile Range|Median
2637862|NCT01777542|Primary|Anxiety, Depression, and Mood Scale (ADAMS) - Social Avoidance Subscale|"The ADAMS is completed by the parent/caregiver/LAR and consists of 29 items which are scored on a 4-point rating scale that combines frequency and severity ratings. The instructions ask the rater to describe the individual's behavior over the last six months on the following scale: 0 if the behavior has not occurred, 1 if the behavior occurs occasionally or is a mild problem, 2 if the behavior occurs quite often or is moderate problem, or 3 if the behavior occurs a lot or is a severe problem.~The Social Avoidance subscale of the ADAMS will be used as a primary outcome measure for this trial. The range for this subscale is 0-21. The higher the subscale score, the more problematic the behavior."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.|||units on a scale||Inter-Quartile Range|Median
2637863|NCT01777542|Primary|Rett Syndrome Behavior Questionnaire (RSBQ) - Fear/Anxiety Subscale|"The RSBQ is an informant/parent-completed measure of abnormal behaviors typically observed in individuals with RTT, which is completed by a parent/caregiver/LAR. Each item, grouped into eight domains/factors: General mood, Breathing problems, Body rocking and expressionless face, Hand behaviors, Repetitive face movements, Night-time behaviors, Fear/anxiety and Walking/standing), is scored on a Likert scale of 0-2, according to how well the item describes the individual's behavior. A score of 0 indicates the described item is not true, a score of 1 indicates the described item is somewhat or sometimes true, and a score of 2 indicates the described item is very true or often true.~The total sum of items in each subscale is reported.~For the fear/anxiety subscale, the sum total could be between 0-8. The higher the sum total score, the greater the frequency of fear/anxiety behaviors."|Every 5 weeks during each of the two 20-week treatment periods, and once 4 weeks after final treatment ends|In some cases, the number of participants analyzed is less than 15 for each group due to caregiver(s) not completing the forms.|||units on a scale||Inter-Quartile Range|Median
2637864|NCT01777490|Secondary|Caregiver Depressive Symptoms|The investigators selected the Center for Epidemiological Studies-Depression 10 scale (CESD-10) measure of depressive symptoms because the respondent burden is low and in order to maximize comparability with REACH I and REACH II. Range is 0-30 with a higher score indicates greater depressive symptoms. Mean was estimated using a linear mixed model.|3 months|All enrolled caregiver subjects were included in the analysis of this outcome, except for the one dayd who withdrew permission to use data.|||units on a scale||95% Confidence Interval|Mean
2637865|NCT01777490|Secondary|Satisfaction With Healthcare|"Consumer Assessment of Healthcare Providers and Systems (CAHPS). Used by the VA Office of Performance and Quality, this outcome is considered a key measure of patient satisfaction with inpatient and outpatient care. The investigators will focus on a global satisfaction measure about the health plan: Using any number from 0 to 10, where 0 is the worst health care possible and 10 is the best health care possible, what number would [PATIENT: you/the patient (if not competent to answer for themselves) use to rate all of your/his/her] [CAREGIVER: you use to rate all the patient's] health care in the VA in the last 3 months? This measure was asked of both the patient and their informal caregiver. If the patient was not competent to answer for themselves, the caregiver was asked to respond on the patient's behalf. Mean was estimated using a linear mixed model."|3 months|This measure was collected from both the patient (or their proxy if not competent) and their informal caregiver. We had one dyad who withdrew from Arm 2 (HI FIVES) and asked us not to use their data.|||units on a scale||95% Confidence Interval|Mean
2637866|NCT01777490|Secondary|Total Costs to the VA|VA utilization costs will be summarized across VA and non-VA contracted care and will capture all outpatient costs (laboratory, radiology, pharmacy, surgery, nursing, and treat and release ED visits) and inpatient costs (similar categories). Mean was estimated using a generalized linear model.|12 months|All enrolled patient subjects were included in the analysis of this outcome, except for the one subject who withdrew permission to use data.|||Dollars||95% Confidence Interval|Mean
2650720|NCT01666782|Secondary|Evaluate and Compare the Local Solicited Adverse Events to Both Vaccines.|Local solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine|7 days||||participants|||Number
2637868|NCT01777438|Secondary|Percentage of Patients That Met ARIA Criteria for Mild AR Symtoms at a Mean Interval of 3 Years After Diagnosis|"ARIA classification of AR is made by duration and severity of AR symptoms. Here are calculated the number of patients having mild acute rhinitis.~Clinical practice guidelines such as the Allergic Rhinitis and its Impact on Asthma (ARIA) document focus on the quality of life as a principal consideration in assessment and treatment of AR"|3 years after diagnosis||||percentage of participants|||Number
2637869|NCT01777438|Primary|Degree of Symptom Control 3 Years After IT or 3 Years After Medical Treatment With VAS of Total Nasal Symptom < 5/10 Defined as a Controlled Situation.|Visual analogue scale (VAS) scores for TNS experienced during the last 4 weeks. Visual analog scales (VAS) have been used to rate the presence of symptoms or impairment of the daily activities. Patients had to answer each question by indicating a position with a vertical line between two endpoints, 0 cm for not bothersome versus 10 cm for extremely bothersome. In this way each question is scored between 0 and 10 points.|3 years after diagnosis||||Score on a scale||Standard Deviation|Mean
2637870|NCT01777438|Secondary|Percentage of Patients Having Controlled Allergic Rhinosinusitis (AR) Symptoms 3 Years After Starting Treatment|Based on the proposed cut-off value of VAS < 5/10 for total nasal symptoms (TNS), rhinitis was considered as being controlled in 69 IT patients (84%) versus 223 (63%) non-IT patients|3 years after starting SCIT||||percentage of participants|||Number
2637871|NCT01777438|Primary|Current Medication Use Three Years After Diagnosis of AR|Percentage patients in both groups that still use medication for their allergic rhinitis symptoms, 3 years after starting their therapy (non IT-group vs IT-group)|3 years after starting SCIT||||percentage of participants|||Number
2637872|NCT01777425|Other Pre-specified|Visual Analogue Scale (VAS), Sinonasal Outcome Test (SNOT22) and Short Form (36) Health Survey (SF36) Score Three Years After ESS in Controlled, Partially Controlled and Uncontrolled Group|"VAS scores: a measurement of patient's subjective evaluation by indicating a position on a line between two endpoints. Patients will score eight individual symptoms on a scale from 0 until 10, being 0 no trouble and 10 maximum trouble. Finally a mean symptom score will be calculated per symptom.~The SNOT-22 questionnaire is a validated 22 item questionnaire. patients indicate how much they are affected in eight different areas and identify the 5 most important items. The SNOT-22 total score can range from 0 to 110, with higher scores representing worse quality of life.~Perceived health status can be evaluated by the 36-item short-form (SF-36). It consists of 36 items covering eight domains. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability"|three years after ESS||||units on a scale||Standard Deviation|Mean
2637873|NCT01777425|Secondary|Control Nasal Endoscopy|Evaluating of difference in control if nasal endoscopy is performed three years after ESS.|3 years after ESS|fully controlled status with endoscopic evaluation|||percentage of participants|||Number
2637874|NCT01777425|Primary|Control Status of Patients With Rhinosinusitis|1. Percentage of patients with rhinosinusitis that are fully controlled, partly controlled and uncontrolled according to the new european position paper on rhinosinusitis (EPOS) definitions at a mean interval of 3 years after endoscopic sinus surgery.|3 years after FESS||||percentage of participants|||Number
2637875|NCT01777412|Primary|Follow-Up Expanded Disability Status Score (EDSS)|"EDSS~The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability."|Follow-up visit 91 days after admission||||units on a scale||Inter-Quartile Range|Median
2637876|NCT01777412|Primary|Safety Assessment and Side Effects|Frequency and severity of adverse events and side effects. Serious adverse events are considered those which are life threatening, lead to hospitalization and related to the drug. Side effects are considered minor effects of the experimental drug that do not significantly impact the care of the patient with the experimental drug.|91 days||||participants|||Number
2637877|NCT01777412|Primary|Baseline Expanded Disability Status Score (EDSS)|"EDSS~The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability."|Admission to hospital||||units on a scale||Inter-Quartile Range|Median
2637878|NCT01777334|Secondary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 84, and 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from BL at a particular visit was calculated as the WM value at that visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by BL and day by treatment interactions.|Baseline and Day 168|ITT Population. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-Baseline measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2637891|NCT01777321|Primary|Number of Subjects With Solicited Local Symptoms|The solicited local symptoms assessed were: Arm movement/range of motion of the vaccinated arm, Injection site pruritus, Pain, Redness, and Swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest that prevented normal every day activities. Grade 3 Injection site pruritus = Significant pruritus that prevented normal every day activities. Grade 3 impairment of arm movement/range of motion = Significant impairment of arm movement/range of motion that prevented normal every day activities.|During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and who had their symptom sheet filled-in.|||Participants|||Count of Participants
2638563|NCT01772576|Other Pre-specified|Complication Free Rate|Lead-related Complication-Free Rate from 3 Months through 24 Months Post-Implant|3 Months through 24 Months Post-Implant|Patients remaining after the 3 months follow-up in the study until the 24 months follow-up.|||percentage of all participants||95% Confidence Interval|Number
2637879|NCT01777334|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 140, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes (min) pre-dose and 5 min pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours (hr) after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hr after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 value at that visit minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessmentsmade 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 169|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study drug during the Treatment Period. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-BL measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2637880|NCT01777321|Secondary|Number of Subjects With SAEs|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to Month 14 post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Participants|||Count of Participants
2637881|NCT01777321|Secondary|Number of Subjects With pIMDs|Potential immune-mediated diseases (pIMDs) were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Up to Month 14 post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Participants|||Count of Participants
2637882|NCT01777321|Secondary|Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations|Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.|Twelve Months after Dose 2 (M14)|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available.|||Participants|||Count of Participants
2637883|NCT01777321|Secondary|Anti-gE Antibody Concentrations|Anti-gE antibody concentrations were expressed as geometric mean concnetrations (GMCs) and measured in mIU/mL.|At Month 14|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2637884|NCT01777321|Secondary|Number of Subjects With Anti-gE Antibody Concentrations ≥ 97 mIU/mL|A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value of 97 mIU/mL.|At Month 14|The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available.|||Participants|||Count of Participants
2637885|NCT01777321|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 to Month 3|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Participants|||Count of Participants
2637886|NCT01777321|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within 30 days (Days 0-29) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Participants|||Count of Participants
2637887|NCT01777321|Primary|Number of Subjects With Potential Immune-Mediated Disorders (pIMDs)|Potential immune-mediated diseases (pIMDs) were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From Month 0 to Month 3|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Participants|||Count of Participants
2637888|NCT01777321|Primary|Mean Number of Days With General Symptoms|Days with solicited general symptoms were tabulated for the total vaccinated cohort.|During the 7 day (Days 0-6) post vaccination, after each dose (D)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Days||Inter-Quartile Range|Mean
2637889|NCT01777321|Primary|Mean Number of Days With Local Symptoms|Days with solicited local symptoms were tabulated for the total vaccinated cohort.|During the 7 day (Days 0-6) post vaccination, after each dose (D)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Days||Inter-Quartile Range|Mean
2637890|NCT01777321|Primary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were: Fatigue, Fever, Gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), Headache, Myalgia, and Shivering. Fever = axillary temperature ≥37.5°C. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Fever = axillary temperature higher than (>) 39.0°C. Related = general symptom assessed by the investigator as causally related to vaccination.|During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and who had their symptom sheet filled-in.|||Participants|||Count of Participants
2637892|NCT01777321|Primary|Descriptive Statistics of Anti-gE Antibody Concentrations|Anti-gE antibody concentrations were assessed by the Enzyme Lynked Immunosorbent Assay.|Before vaccination (PRE), at two months after dose 1 (M2) and one month after Dose 2 (M3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||Standard Deviation|Median
2637893|NCT01777321|Primary|Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations|Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x18 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.|At two months after Dose 1 (M2) and one month after Dose 2 (M3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2637894|NCT01777321|Primary|Anti-gE Antibody Concentrations|Anti-gE antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in mIU/mL.|Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2637895|NCT01777321|Primary|Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL)|A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value, of 18 mIU/mL.|Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2637896|NCT01777308|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 72 up to study end, at Month 96|The analysis was performed on the Total Vaccinated cohort (TVc) for safety at Month 73, which included all vaccinated subjects in the study Hib-MenC-TT-016 (NCT00326118) with a Nimenrix™ booster vaccine administration documented.|||Participants|||Count of Participants
2637897|NCT01777308|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the 31-day (Days 0-30) post-booster vaccination period at Month 72|The analysis was performed on the Total Vaccinated cohort (TVc) for safety at Month 73, which included all vaccinated subjects in the study Hib-MenC-TT-016 (NCT00326118) with a Nimenrix™ booster vaccine administration documented.|||Participants|||Count of Participants
2637898|NCT01777308|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-booster vaccination period at Month 72|The analysis was performed on the Total Vaccinated cohort (TVc) for safety at Month 73, which included all vaccinated subjects in the study Hib-MenC-TT-016 (NCT00326118) with a Nimenrix™ booster vaccine administration documented.|||Participants|||Count of Participants
2637899|NCT01777308|Secondary|Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|During the 31-day (Days 0-30) post-booster vaccination period at Month 72|The analysis was performed on the Total Vaccinated cohort (TVc) for safety at Month 73, which included all vaccinated subjects in the study Hib-MenC-TT-016 (NCT00326118) with a Nimenrix™ booster vaccine administration documented.|||Participants|||Count of Participants
2637900|NCT01777308|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, and fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-booster vaccination period at Month 72|The analysis was performed on the Total Vaccinated cohort (TVc) for safety at Month 73, which included all vaccinated subjects in the study Hib-MenC-TT-016 (NCT00326118) with a Nimenrix™ booster vaccine administration documented.|||Participants|||Count of Participants
2637901|NCT01777308|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms included pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-booster vaccination period at Month 72|The analysis was performed on the Total Vaccinated cohort (TVc) for safety at Month 73, which included all vaccinated subjects in the study Hib-MenC-TT-016 (NCT00326118) with a Nimenrix™ booster vaccine administration documented.|||Participants|||Count of Participants
2637902|NCT01777308|Secondary|Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY|Antibody titers were presented as geometric mean titers (GMTs).|At Month 96, 24 months post-booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Month 96, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen at 24 months post booster vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2637903|NCT01777308|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values|The cut-off values for the rSBA titers were greater than or equal to (≥) 1:8 and 1:128.|At Month 96, 24 months post-booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Month 96, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen at 24 months post booster vaccination.|||Participants|||Count of Participants
2637904|NCT01777308|Secondary|Antibody Concentrations Against Tetanus (Anti-T) Antigen|Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).|At Month 73, one month post-booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Month 73, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month post-vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2637905|NCT01777308|Secondary|Number of Subjects With Anti-tetanus (Anti-T) Concentrations ≥ the Predefined Cut-off Values|The cut-off values for anti-T concentrations were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.|At Month 73, one month post-booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Month 73, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month post-vaccination.|||Participants|||Count of Participants
2637906|NCT01777308|Secondary|Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY|Antibody titers were presented as geometric mean titers (GMTs).|At Month 73, one month post-booster vaccination|The analysis was performed on the Adapted ATP cohort at Month 73, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month post-vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2637907|NCT01777308|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values|The cut-off values for the rSBA titers were greater than or equal to (≥) 1:8 and 1:128.|At Month 73, one month post-booster vaccination|The analysis was performed on the Adapted ATP cohort at Month 73, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month post-vaccination.|||Participants|||Count of Participants
2637908|NCT01777308|Primary|Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroup A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY)|Vaccine response was defined as: For initially seronegative subjects (pre-vaccination rSBA titer below 1:8), antibody titer greater than or equal to (≥) 1:32 at post-vaccination; for initially seropositive subjects, antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer.|At Month 73, one month post-booster vaccination|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Month 73, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month post-vaccination.|||Participants|||Count of Participants
2637909|NCT01777295|Secondary|Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step|Assessed solicited symptoms were fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], pain, redness [spreading beyond 20 millimeters (mm) of injection site], induration [spreading beyond 20 millimeters (mm) of injection site], swelling [spreading beyond 20 millimeters (mm) of injection site] and muscle stiffness.|Up to 3 days post-Dose 2 vaccine administration in HBsAg/AS_1+2 Group|The analysis was performed on the Total Vaccinated cohort, of the HBsAg/AS_1+2 Group only, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2637910|NCT01777295|Secondary|Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2|Assessed solicited symptoms were fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], pain, redness [spreading beyond 20 millimeters (mm) of injection site], induration [spreading beyond 20 millimeters (mm) of injection site], swelling [spreading beyond 20 millimeters (mm) of injection site] and muscle stiffness.|Up to 3 days post-placebo/vaccine administration.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2637911|NCT01777295|Secondary|Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1|Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluster of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).|At Day 0 prior to vaccination (PRE), Day 44 and Day 180 post-vaccination|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence (step 1 only) included all evaluable subjects, who complied with the protocol, for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at Day 180.|||T ceclls/ million cells||Inter-Quartile Range|Median
2637912|NCT01777295|Secondary|Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1|Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluste of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).|At Day 0 prior to vaccination (PRE) and Day 44 post-vaccination|The analysis was performed on the ATP cohort for adaptive immunogenicity up to Day 60 (step 1 only) which included all evaluable subjects who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point (up to Day 60).|||T cells/ million cells||Inter-Quartile Range|Median
2637913|NCT01777295|Secondary|Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1|Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluster of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).|At Day 0 prior to vaccination (PRE), Day 44 and Day 180 post-vaccination|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence (step 1 only) included all evaluable subjects, who complied with the protocol, for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at Day 180.|||T cells/ million cells||Inter-Quartile Range|Median
2637914|NCT01777295|Secondary|-Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1|Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluster of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).|At Day 0 prior to vaccination (PRE) and Day 44 post-vaccination|The analysis was performed on the ATP cohort for adaptive immunogenicity up to Day 60 (step 1 only) which included all evaluable subjects who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point (up to Day 60).|||T cells/million cells||Inter-Quartile Range|Median
2637915|NCT01777295|Secondary|Levels of Systolic Pressure - Step 2|Systolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days 30 and 180, systolic pressure was assessed at multiple time points (plus 0 and 6 hours - H0, H6).|At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||mmHg||Inter-Quartile Range|Median
2637916|NCT01777295|Secondary|Levels of Respiratory Rate - Step 2|Respiratory Rate was part of the list of vital signs followed at specific protocol-defined time points during this study. It was expressed as breaths per minute (breaths/min). On Days 30 and 180, respiratory rate was assessed at multiple time points (plus 0 and 6 hours - H0, H6).|At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||breaths/min||Inter-Quartile Range|Median
2637917|NCT01777295|Secondary|Levels of Heart Rate - Step 2|Heart rate was part of the list of vital signs followed at specific protocol-defined time points during this study. It was expressed in beats per minute. On Days 30 and 180, heart rate was assessed at multiple time points (plus 0 and 6 hours - H0, H6).|At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||beats/minute||Inter-Quartile Range|Median
2637918|NCT01777295|Secondary|Levels of Diastolic Blood Pressure - Step 2|Diastolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days 30 and 180, diastolic blood pressure was assessed at multiple time points (plus 0 and 6 hours - H0, H6).|At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||mmHg||Inter-Quartile Range|Median
2637919|NCT01777295|Secondary|Levels of Total Bilirubin in Blood Samples - Step 2|Biochemical laboratory parameters assessed included total bilirubin levels. Bilirubin concentrations were expressed in milligrams per deciliter (mG/dL).|At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||mg/dL||Inter-Quartile Range|Median
2637920|NCT01777295|Secondary|Platelet Count in Blood Samples - Step 2|Haematological laboratory parameters assessed included platelet count levels. Platelet count levels were expressed in billion cells per liter (billion cells/L).|At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||billion cells/L||Inter-Quartile Range|Median
2637921|NCT01777295|Secondary|Levels of Neutrophils in Blood Samples - Step 2|Haematological laboratory parameters assessed included neutrophil levels. Neutrophil levels were expressed in billion cells per liter (billion cells/L).|At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||billion cells/L||Inter-Quartile Range|Median
2637922|NCT01777295|Secondary|Levels of Monocytes in Blood Samples - Step 2|Haematological laboratory parameters assessed included monocyte levels. Monocyte levels were expressed in billion cells per liter (billion cells/L).|At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||billion cells/L||Inter-Quartile Range|Median
2637923|NCT01777295|Secondary|Levels of Lymphocytes in Blood Samples - Step 2|Haematological laboratory parameters assessed included lymphocyte levels. Lymphocyte levels were expressed in billion cells per liter (billion cells/L).|At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||billion cells/L||Inter-Quartile Range|Median
2637924|NCT01777295|Secondary|Levels of White Blood Cell (WBC) in Blood Samples - Step 2|Haematological laboratory parameters assessed included white blood cells levels. WBC levels were expressed in billion cells per liter (billion cells/L).|At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||billion cells/L||Inter-Quartile Range|Median
2638100|NCT01776645|Secondary|Change in Brief Pain Inventory|Interference score - Interference as measured by a 0 to 10 numerical rating scale. 0 = does not interfere, 10 = completely interferes|Baseline to end of 9-week treatment protocol|2 participants excluded from analysis: 1 did not complete the final questionnaire battery, 1 reported no pain at baseline and thus could not be included as a patient with chronic pain|||units on a scale||Standard Deviation|Mean
2637925|NCT01777295|Secondary|Levels of Eosinophils in Blood Samples - Step 2|Haematological laboratory parameters assessed included eosinophil levels. Eosinophil levels were expressed in billion cells per liter (billion cells/L).|At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||billion cells/L||Inter-Quartile Range|Median
2637926|NCT01777295|Secondary|Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2|Biochemical laboratory parameters assessed included CRP levels. CRP concentrations were expressed in milligrams per liter (mg/L).|At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||mg/L||Inter-Quartile Range|Median
2637927|NCT01777295|Secondary|Levels of Basophils in Blood Samples - Step 2|Haematological laboratory parameters assessed included basophil levels. Basophil levels were expressed in billion cells per liter (billion cells/L).|At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||billion cells/L||Inter-Quartile Range|Median
2637928|NCT01777295|Secondary|Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2|Biochemical laboratory parameters assessed included AST levels. AST concentrations were expressed in units per liter (U/L).|At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||U/L||Inter-Quartile Range|Median
2637929|NCT01777295|Secondary|Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2|Biochemical laboratory parameters assessed included ALT levels. ALT concentrations were expressed in units per liter (U/L).|At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||U/L||Inter-Quartile Range|Median
2637930|NCT01777295|Secondary|Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Pooling Step|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2637931|NCT01777295|Secondary|Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 2|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.|Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2637932|NCT01777295|Secondary|Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Pooling Step|PIMD(s) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2637933|NCT01777295|Secondary|Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 2|PIMD(s) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented|||Participants|||Count of Participants
2637934|NCT01777295|Secondary|Number of Subjects With Serious Adverse Events (SAEs) - Pooling Step|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2637935|NCT01777295|Secondary|Number of Subjects With Serious Adverse Events (SAEs) - Step 2|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2637936|NCT01777295|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) - Pooling Step|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 28-day (Days 0-27) post-vaccination period.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2638101|NCT01776645|Other Pre-specified|Change in Compassion|As assessed by Pommier's Compassion for Other's Scale|Baseline and end of 9-week treatment protocol|||||||
2638102|NCT01776645|Other Pre-specified|Change in Compassion|As assessed by Compassionate Love Scale adapted for close other|Baseline and end of 9-week treatment protocol|||||||
2637937|NCT01777295|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 2|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 28-day (Days 0-27) and post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2637938|NCT01777295|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise, myalgia, shivering and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. There was no pooling for temperature symptom between Step 1 and Step 2 due to difference in recording approach for the 18 hour data (nurse or self-assessment).|During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2637939|NCT01777295|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache, malaise, myalgia, shivering and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. At Day 0 of dose 2, two temperatures were collected: one at Hour 0 (H0) and a second one at Hour 18 (H18). The highest temperature between H0 et H18 was taken.|During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2637940|NCT01777295|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2637941|NCT01777295|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2637942|NCT01777295|Secondary|Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Persistence|Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL).|At Day 0 (PRE) and post-vaccination (Day 44 for HBsAg/AS_2 Group and Day 194 for Engerix-B_2 Group)|The analysis was performed on the According-To-Protocol (ATP) cohort for persistence (step 2 only) included all evaluable subjects, who complied with the protocol, for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at Day 180 for the HBsAg/AS_2 Group and at Day 330 for the Engerix-B_2 Group.|||mIU/mL||95% Confidence Interval|Geometric Mean
2637943|NCT01777295|Secondary|Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Immuno|Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL).|At Day 0 (PRE) and post-vaccination (Day 44 for HBsAg/AS_2 Group and Day 194 for Engerix-B_2 Group)|Analyses were performed on the According-To-Protocol (ATP) cohort for adaptive immunogenicity up to 30 days (step 2 only) post last vaccination, which included all evaluable subjects, who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point.|||mIU/mL||95% Confidence Interval|Geometric Mean
2637944|NCT01777295|Secondary|Levels of Systolic Pressure - Step 1|Systolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days -30, 0 and 30, systolic pressure was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18).|At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||mmHg||Inter-Quartile Range|Median
2637945|NCT01777295|Secondary|Levels of Respiratory Rate - Step 1|Respiratory Rate was part of the list of vital signs followed at specific protocol-defined timepoints during this study. It was expressed as breaths per minute (breaths/min). On Days -30, 0 and 30, respiratory rate was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18).|At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||breaths/min||Inter-Quartile Range|Median
2638103|NCT01776645|Other Pre-specified|Change in Overall Health and Well-being|As assessed by PROMIS Global Health Scale|Baseline and end of 9-week treatment protocol|||||||
2638104|NCT01776645|Other Pre-specified|Change in Emotional Distress|As assessed by the PROMIS Social Isolation Scale|Baseline and end of 9-week treatment protocol|||||||
2637946|NCT01777295|Secondary|Levels of Heart Rate - Step 1|Heart rate was part of the list of vital signs followed at specific protocol-defined timepoints during this study. It was expressed in beats per minute. On Days -30, 0 and 30, heart rate was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18).|At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||beats/minute||Inter-Quartile Range|Median
2637947|NCT01777295|Secondary|Levels of Diastolic Blood Pressure - Step 1|Diastolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days -30, 0 and 30, diastolic blood pressure was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18).|At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||mmHg||Inter-Quartile Range|Median
2637948|NCT01777295|Secondary|Levels of White Blood Cells (WBC) - Step 1|Haematological laboratory parameters assessed included WBC levels. WBC levels were expressed in billion cells per liter (billion cells/L). WBC levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.|At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||billion cells/L||Inter-Quartile Range|Median
2637949|NCT01777295|Secondary|Levels of Urea in Blood Samples - Step 1|Biochemical laboratory parameters assessed included urea levels, expressed in miligrams per deciliter (mg/dL). Urea levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.|At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||mg/dL||Inter-Quartile Range|Median
2637950|NCT01777295|Secondary|Levels of Red Blood Cell (RBC) in Blood Samples - Step 1|Haematological laboratory parameters assessed included red blood cells levels, expressed in trillion cells per liter (trillion cells/L). RBC levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.|At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||trillion cells/L||Inter-Quartile Range|Median
2637951|NCT01777295|Secondary|Platelet Count in Blood Samples - Step 1|Haematological laboratory parameters assessed included platelet count levels. Platelet count levels were expressed in billion cells per liter (billion cells/L). Platelet count levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.|At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||billion cells/L||Inter-Quartile Range|Median
2637952|NCT01777295|Secondary|Levels of Neutrophils in Blood Samples - Step 1|Haematological laboratory parameters assessed included neutrophil levels. Neutrophil levels were expressed in billion cells per liter (billion cells/L). Neutrophil levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.|At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||billion cells/L||Inter-Quartile Range|Median
2637953|NCT01777295|Secondary|Levels of Monocytes in Blood Samples - Step 1|Haematological laboratory parameters assessed included monocyte levels. Monocyte levels were expressed in billion cells per liter (billion cells/L). Monocyte levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.|At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||billion cells/L||Inter-Quartile Range|Median
2637954|NCT01777295|Secondary|Levels of Lymphocytes in Blood Samples - Step 1|Haematological laboratory parameters assessed included lymphocyte levels. Lymphocyte levels were expressed in billion cells per liter (billion cells/L). Lymphocyte levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.|At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||billion cells/L||Inter-Quartile Range|Median
2637955|NCT01777295|Secondary|Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1|Biochemical laboratory parameters assessed included LDH levels, expressed in units per liter (U/L). LDH levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.|At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||U/L||Inter-Quartile Range|Median
2637956|NCT01777295|Secondary|Levels of Haemoglobin in Blood Samples - Step 1|Haematological laboratory parameters assessed included haemoglobin levels, expressed in grams per deciliter (g/dL). Haemoglobin levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.|At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||g/dL||Inter-Quartile Range|Median
2638034|NCT01777191|Secondary|Percentage of Device Operation Failures|Device operation failure (that is, incomplete dose administration) was defined as an event during the treatment period (week 0 to week 12) when the participant indicated that a complete dose of ixekizumab was not delivered and/or the drug delivery device did not perform as expected per the directions for use.|Baseline through Week 12|All randomized participants.|||percentage of incomplete injections|Injections||Number
2637957|NCT01777295|Secondary|Levels of Eosinophils in Blood Samples - Step 1|Haematological laboratory parameters assessed included eosinophil levels. Eosinophil levels were expressed in billion cells per liter (billion cells/L). Eosinophil levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.|At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||billion cells/L||Inter-Quartile Range|Median
2637958|NCT01777295|Secondary|Levels of C-reactive Protein (CRP) in Blood Samples - Step 1|Biochemical laboratory parameters assessed included CRP levels. CRP concentrations were expressed in milligrams per liter (mg/L). CRP levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.|At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||mg/L||Inter-Quartile Range|Median
2637959|NCT01777295|Secondary|Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1|Biochemical laboratory parameters assessed included CPK levels. CPK concentrations were expressed in milligrams per deciliter (mg/dL). CPK levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.|At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||mg/dL||Inter-Quartile Range|Median
2637960|NCT01777295|Secondary|Levels of Serum Creatinine in Blood Samples - Step 1|Biochemical laboratory parameters assessed included creatinine levels. Creatinine concentrations were expressed in milligrams per deciliter (mg/dL). Creatinine levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.|At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||mg/dL||Inter-Quartile Range|Median
2637961|NCT01777295|Secondary|Levels of Total Bilirubin in Blood Samples - Step 1|Biochemical laboratory parameters assessed included total bilirubin levels. Bilirubin concentrations were expressed in milligrams per deciliter (mG/dL). Bilirubin levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.|At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||mg/dL||Inter-Quartile Range|Median
2637962|NCT01777295|Secondary|Levels of Basophils in Blood Samples - Step 1|Haematological laboratory parameters assessed included basophil levels. Basophil levels were expressed in billion cells per liter (billion cells/L). Basophil levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.|At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||billion cells/L||Inter-Quartile Range|Median
2637963|NCT01777295|Secondary|Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1|Biochemical laboratory parameters assessed included AST levels. AST concentrations were expressed in units per liter (U/L). AST levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.|At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||U/L||Inter-Quartile Range|Median
2637964|NCT01777295|Secondary|Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1|Biochemical laboratory parameters assessed included ALT levels. ALT concentrations were expressed in units per liter (U/L). ALT levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.|At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||U/L||Inter-Quartile Range|Median
2637965|NCT01777295|Secondary|Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 1|MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.|From Day 0 up to Day 60 for the HBsAg/AS_1 Group and from Day 0 up to Day 210 for the Engerix-B_1 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2637966|NCT01777295|Secondary|Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 1|PIMD(s) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From Day 0 up to Day 60 for the HBsAg/AS_1 Group and from Day 0 up to Day 210 for the Engerix-B_1 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2637967|NCT01777295|Secondary|Number of Subjects With Serious Adverse Events (SAEs) - Step 1|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 up to Day 60 for the HBsAg/AS_1 Group and from Day 0 up to Day 210 for the Engerix-B_1 Group|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2638035|NCT01777191|Secondary|Percentage of Participants With a Static Physician Global Assessment (sPGA) (0)|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 12|All randomized participants. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.|||percentage of participants|||Number
2637968|NCT01777295|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 1|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 28-day (Days 0-27) post-placebo (PP) and post-product administration period.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2637969|NCT01777295|Secondary|Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1|Assessed solicited symptoms were fever [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], pain, redness [spreading beyond 20 millimeters (mm) of injection site], induration [spreading beyond 20 millimeters (mm) of injection site], swelling [spreading beyond 20 millimeters (mm) of injection site] and muscle stiffness.|Up to 4 days post-placebo/vaccine administration.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2637970|NCT01777295|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms [nausea, vomiting, diarrhoea and /or abdominal pain], headache, malaise, myalgia, shivering and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination|During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented, who have filled in their symptom sheets.|||Participants|||Count of Participants
2637971|NCT01777295|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented, who have filled in their symptom sheets.|||Participants|||Count of Participants
2637972|NCT01777295|Secondary|Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 1|Anti-HBs antibody concentrations in serum were measured by Chemi Luminiscence Immuno Assay (CLIA). Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL).|At Day 0 (PRE) and Day 60 (D60) post-vaccination|The analysis was performed on the ATP cohort for adaptive immunogenicity up to Day 60 (step 1 only) which included all evaluable subjects who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point (up to Day 60).|||mIU/mL||95% Confidence Interval|Geometric Mean
2637973|NCT01777295|Primary|Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the Engerix-B_2 Group.|Post-dose 3 at Day 187|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2637974|NCT01777295|Primary|Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the Engerix-B_2 Group.|Post-dose 3 at Day 181|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.|||pg/mL||Inter-Quartile Range|Median
2637975|NCT01777295|Primary|Plasma Concentrations of Cytokines and Chemokines - Study Step 2|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.The analysis was performed only on theEngerix-B_2 Group.|Post-dose 3 at Day 180 plus 6 Hours|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.|||pg/mL||Inter-Quartile Range|Median
2638105|NCT01776645|Other Pre-specified|Change in Emotional Distress|As Assessed by the PROMIS Anger Scale|Baseline and end of 9-week treatment protocol|||||||
2637976|NCT01777295|Primary|Concentrations of Cytokines/Chemokines During Step 2|"Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.~The analysis was performed only on the Engerix-B_2 Group."|Post-dose 2 at Day 180|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.|||pg/mL||Inter-Quartile Range|Median
2637977|NCT01777295|Primary|Concentrations of Cytokines/Chemokines in Step 2|"Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.~The analysis was performed only on the HBsAg/AS_2 Group."|Post-dose 2 at Day 37|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.|||pg/mL||Inter-Quartile Range|Median
2637978|NCT01777295|Primary|Concentrations of Cytokines/Chemokines - Step 2|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS_2 Group.|Post-dose 2 at Day 31|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.|||pg/mL||Inter-Quartile Range|Median
2637979|NCT01777295|Primary|Concentrations of Cytokines and Chemokines in Step 2|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS_2 Group.|Post-dose2 at Day 30 plus 6 Hours|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.|||pg/mL||Inter-Quartile Range|Median
2637980|NCT01777295|Primary|Concentrations of Cytokines and Chemokines During Step 2|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS_2 Group.|Post-dose 1 at Day 30|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.|||pg/mL||Inter-Quartile Range|Median
2637981|NCT01777295|Primary|Cytokines and Chemokines Concentrations - Step 2|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS_2 Group.|Post-dose 1 at Day 1|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.|||pg/mL||Inter-Quartile Range|Median
2638033|NCT01777191|Secondary|Percentage of Participants With Anti-Ixekizumab Antibodies|The percentage of participants with treatment-emergent positive anti-ixekizumab antibodies at anytime post-baseline were summarized by drug delivery device group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.|Baseline to Week 12|All randomized participants who received a least 1 dose of study drug during the Treatment Period and had evaluable data.|||percentage of participants|||Number
2638106|NCT01776645|Other Pre-specified|Qualitative Measures|Qualitative analysis of interviews|Baseline and end of 9-week treatment protocol|||||||
2637982|NCT01777295|Primary|Concentrations of Cytokines and Chemokines - Step 2|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Pre-dose 1 at Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.|||pg/mL||Inter-Quartile Range|Median
2637983|NCT01777295|Primary|Concentrations of Plasma Cytokines and Chemokines During Step 1|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-dose 2 at Day 37|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2637984|NCT01777295|Primary|Concentrations of Plasma Cytokines and Chemokines in Step 1|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-dose 2 at Day 33|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2637985|NCT01777295|Primary|Concentrations of Plasma Cytokines and Chemokines - Step 1|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-dose 2 at Day 32|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2637986|NCT01777295|Primary|Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-dose 2 at Day 31|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2637987|NCT01777295|Primary|Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-dose 2 at Day 30 plus 18 Hours|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2637988|NCT01777295|Primary|Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-dose 2 at Day 30 plus 12 Hours|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2638107|NCT01776645|Other Pre-specified|Change in Compassion|As assessed by Neff's Self-Compassion Scale|Baseline and end of 9-week treatment protocol|||||||
2637989|NCT01777295|Primary|Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-dose 2 at Day 30 plus 9 Hours|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2637990|NCT01777295|Primary|Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-dose 2 at Day 30 plus 6 hours|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2637991|NCT01777295|Primary|Plasma Concentrations of Cytokines and Chemokines - Study Step 1|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-dose 2 at Day 30 plus 3 Hours|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2637992|NCT01777295|Primary|Plasma Concentrations of Cytokines and Chemokines - Step 1|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-dose 2 at Day 30 plus 1.5 Hours|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2637993|NCT01777295|Primary|Cytokines/Chemokines Concentrations During Step 1 of Study|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-dose1 at Day 30|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2637994|NCT01777295|Primary|Cytokines/Chemokines Concentrations in Step 1 of Study|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-dose1 at Day 7|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2637995|NCT01777295|Primary|Cytokines/Chemokines Concentrations - Study Step 1|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-dose1 at Day 2|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2637996|NCT01777295|Primary|Cytokines and Chemokines Concentrations During Step 1 of Study|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-dose1 at Day 1|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2637997|NCT01777295|Primary|Cytokines and Chemokines Concentrations in Step 1 of Study|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-dose1 at Day 0 plus 18 Hours|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2637998|NCT01777295|Primary|Cytokines and Chemokines Concentrations - Study Step 1|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-dose1 at Day 0 plus 12 Hours|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2637999|NCT01777295|Primary|Concentrations of Cytokines and Chemokines During Step 1 of Study|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-dose1 at Day 0 plus 6 Hours|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2638000|NCT01777295|Primary|Concentrations of Cytokines and Chemokines in Step 1 of Study|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-dose1 at Day 0 plus 1.5 Hours|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2638001|NCT01777295|Primary|Concentrations of Cytokines and Chemokines - Study Step 1|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Pre-dose1 at Day 0|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2638002|NCT01777295|Primary|Cytokines and Chemokines Concentrations During Step 1|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-placebo at Day -23|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2638003|NCT01777295|Primary|Cytokines/Chemokines Concentrations in Step 1|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-placebo at Day -27|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2638004|NCT01777295|Primary|Cytokines and Chemokines Concetrations During Step 1|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-placebo at Day -28|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2638005|NCT01777295|Primary|Cytokines and Chemokines Concentrations in Step 1|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-placebo at Day -29|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2638006|NCT01777295|Primary|Concentrations of Cytokines/Chemokines During Step 1|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-placebo at Day -30 plus 18 Hours|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2638007|NCT01777295|Primary|Concentrations of Cytokines/Chemokines in Step 1|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-placebo at Day -30 plus 12 Hours|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2638008|NCT01777295|Primary|Concentrations of Cytokines/Chemokines - Step 1|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-placebo at Day -30 plus 9 Hours|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2638009|NCT01777295|Primary|Concentrations of Cytokines and Chemokines During Step 1|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-placebo at Day -30 plus 6 Hours|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2638108|NCT01776645|Other Pre-specified|Change in Overall Health and Well-being|As assessed by Ryff's psychological well-being scales|Baseline and end of 9-week treatment protocol|||||||
2638010|NCT01777295|Primary|Concentrations of Cytokines and Chemokines in Step 1|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-placebo at Day -30 plus 3 Hours|The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2638011|NCT01777295|Primary|Cytokines and Chemokines Concentrations - Step 1|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|Post-placebo at Day -30 plus 1.5 Hours|Analyses were performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2638012|NCT01777295|Primary|Concentrations of Cytokines and Chemokines - Step 1|Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.|At Day -30 prior to placebo administration|Analyses were performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).|||pg/mL||Inter-Quartile Range|Median
2638013|NCT01777282|Secondary|Time to Study Withdrawal Due to Hyperglycemia|Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose >=280 mg/dL (>=15.5 mmol/L) from >=Week 2 to <Week 12 or >=230 mg/dL (>=12.8 mmol/L) from >=Week 12 to <Week 52.|Week 52|Intent-to-Treat (Last Observation Carried Forward) Population. Only participants who were withdrawn due to hyperglycemia were analyzed.|||Weeks||Standard Deviation|Mean
2638014|NCT01777282|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline weight observation carried forward for the analysis.|Baseline and Week 52|Intent-to-Treat (Last Observation Carried Forward) Population|||Kilograms (kg)||Standard Deviation|Mean
2638015|NCT01777282|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline FPG observation carried forward for the analysis.|Baseline and Week 52|Intent-to-Treat (Last Observation Carried Forward) Population. Only those participants with valid post-Baseline results (within 14 days of last exposure to treatment) were analyzed.|||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2638016|NCT01777282|Secondary|Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0% at Week 52)|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%.|Week 52|Intent-to-Treat (Last Observation Carried Forward) Population|||Percentage of participants|||Number
2638017|NCT01777282|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline. Participants who discontinued from study treatment before Week 52 had their last on-treatment, post-Baseline HbA1c observation carried forward for the analysis.|Baseline and Week 52|Intent-to-Treat (Last Observation Carried Forward) Population: all enrolled participants who received at least 1 dose of study medication and who had at least one HbA1c post-Baseline assessment.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
2638018|NCT01777282|Primary|Number of Participants With Any Hypoglycemic Event|Hypoglycemia events are defined with respect to low plasma glucose level, mostly accompanied by typical symptoms and/or assistance needed from third party with glucose administration. These events were reported by the investigators upon verification of the plasma glucose levels, symptoms and assistance recorded by the participants, and/or plasma glucose values obtained from laboratory evaluations.|From Baseline through Week 52|Safety Population: all participants who received at least 1 dose of study treatment.|||Participants|||Number
2638109|NCT01776645|Other Pre-specified|Change in Emotional Distress|As assessed by the Hospital Anxiety and Depression Scale|Baseline and end of 9-week treatment protocol|||||||
2638110|NCT01776645|Primary|Change in Chronic Pain Acceptance Questionnaire||Baseline and end of 9-week treatment protocol|||||||
2638019|NCT01777282|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs. Non-serious hypoglycemia events are not included.|From Baseline through Week 52|Safety Population: all participants who received at least 1 dose of study treatment.|||Participants|||Number
2638020|NCT01777269|Secondary|Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=25 Percent|Participants with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed.Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 12|ITT Population; Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|||Scores on a scale||Standard Error|Least Squares Mean
2638021|NCT01777269|Secondary|Change From Baseline in Total MSHQ Scores From Baseline at 12 Months Among Participants With IPSS Improvement of >=2 Points and >=3 Points|Total MSHQ score is composed of 3 domain scores: ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Par. with change from baseline in total MSHQ scores with good BPH symptomatic response (measured by improvement in IPSS)were analysed. Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 12|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2638022|NCT01777269|Secondary|Change From Baseline in Perception of Treatment Benefit/Satisfaction With Treatment (Patient Perception of Study Medication - PPSM Questionnaire Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months|Patient Perception of Study Medication (PPSM) is a 12-item questionnaire designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms. The total PPSM score ranges from 7 to 49, with higher scores indicating lower satisfaction. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9, 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline, Week 2, Month 1, 3, 6, 9 and 12|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2638023|NCT01777269|Secondary|Change From Baseline in Quality of Life (BPH Impact Index -BII Scores) at 2 Weeks, 1, 3, 6, 9, and 12 Months|The BPH Impact Index (BII) is a 4-item, self-administered questionnaire evaluating the impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the subject took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 1, 3, 6, 9 and 12|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2638024|NCT01777269|Secondary|Change From Baseline in International Prostate Symptom Score (IPSS) Scores Using the Observed Cases Approach at 2 Weeks, 1, 3, 6, 9, and 12 Months|The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify urinary symptoms: Q1, incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. The score can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from BL were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Week 2, Months 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 1, 3, 6, 9 and 12|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2638405|NCT01774370|Secondary|Percentage of Participants With Systemic Embolism|Systemic embolism was defined as an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and was to be documented by angiography, surgery, scintigraphy or autopsy.|up to 26 weeks|Effectiveness Analysis set|||percentage of participants|||Number
2638025|NCT01777269|Secondary|Change From Baseline in Satisfaction Score at 1, 3, 6, 9 and 12 Months|Satisfaction scale is a domain of MSHQ to assess sexual relationship. SS is the sum of score for questions 13 to 18. The score ranges from 6 (extremely dissatisfied) to 30 (extremely satisfied). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 1, 3, 6, 9 and 12|ITT Population|||Scores on a scale||Standard Deviation|Mean
2638026|NCT01777269|Secondary|Change From Baseline in Ejaculatory Dysfunction (EjD) at 1, 3, 6, 9 and 12 Months|Ejaculation scale is a domain of MSHQ to assess ejaculatory dysfunction. EjS is the sum of score for questions 5 to 11. The score ranges from 1 (could not ejaculate) to 35 (strong ejaculation). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 1, 3, 6, 9 and 12|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2638027|NCT01777269|Secondary|Change From Baseline in Erectile Dysfunction (ED) at 1, 3, 6, 9 and 12 Months|Erection scale is a domain of MSHQ to assess erectile dysfunction. ES is the sum of score for questions 1 to 3. The score ranges from 0 (no erection) to 15 (strong erection). Change from BL at the scheduled post-baseline time points were analyzed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 and 12 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 1, 3, 6, 9 and 12|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2638028|NCT01777269|Secondary|Number of Participants Reaching Various Thresholds of Change in Total MSHQ From Baseline at 12 Months|"Participants reaching thresholds of change in total MSHQ were assessed. Threshold values are defined as multiplicative factor. Threshold included +10 points, +20 points, +25 points, -10 points, -20 points, -25 points; where + indicates improvement and -indicates worsening. Treatment comparisons were done based on categories defined by these thresholds using Mantel-Haenszel test"|Baseline and 12 months|ITT Population; Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles).|||Participants|||Number
2638029|NCT01777269|Secondary|Change From Baseline in Scores From the Full Men's Sexual Health Questionnaire (MSHQ) at 1, 3, 6 and 9 Months|Total MSHQ score is composed of 3 domain scores: ES=sum of score for Q 1 to 3(ranges from 0 to 15), EjS=sum of scores for Q5 to 11(ranges from 1 to 35), SS=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS and the score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analysed using MMRM analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest DB treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 1, 3, 6, 9 values minus BL value(s). Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles)|Baseline and Month 1, 3, 6, and 9|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2638030|NCT01777269|Primary|Changes From Baseline (BL) in Total Score From the Full Men's Sexual Health Questionnaire (MSHQ) at 12 Months|Total MSHQ score is composed of 3 domain scores: Erection score(ES)=sum of score for Questions (Q) 1 to 3(ranges from 0 to 15), Ejaculation score(EjS)=sum of scores for Q5 to 11(ranges from 1 to 35), Satisfaction score(SS)=sum of scores for Q13 to 18(ranges from 6 to 30). Total MSHQ score=ES+EjS+SS. The total MSHQ score ranges from 7-80, with higher scores indicating greater sexual function. Change from BL at scheduled post-BL time points were analyzed using a mixed model repeated measures (MMRM) analysis method with an Observed Cases approach. Values are expressed as adjusted mean along with standard error. The MMRM analysis included fixed categorical effects of treatment, visit and treatment by visit interaction and the continuous fixed covariates of BL total score and BL score by visit interaction. BL is defined as earliest double-blind (DB) treatment start date if the par. took at least one dose of DB study drug; change from BL was calculated as Month 12 value(s) minus BL value(s)|Baseline and 12 months|Intent-to-Treat (ITT): All randomized par. regardless of whether or not treatment was administered. Only those par with non-missing change from baseline data were analysed (presented as n=X,X in the category titles).|||Scores on a scale||Standard Error|Least Squares Mean
2638031|NCT01777217|Primary|Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS).|The AUASS score range is 1-7 (mild), 8-19 (moderate) and 20-35 (severe). The AUASS asks 7 questions scored 0-5, the scores are summed for the total score.|baseline and 16 weeks||||Scores on a scale||Standard Deviation|Median
2638032|NCT01777191|Secondary|SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)|"The SQAAQ is a self-administered questionnaire which provides an assessment of ease of use and confidence with using a device to administer a subcutaneous injection of drug. Participants and injection assistants responded to questionnaire items using a 7-point Likert scale (from Strongly Disagree to Strongly Agree). 1 represents Strongly Disagree while 7 represents Strongly Agree. The ease of use and confidence of ixekizumab subcutaneous administrations across drug delivery device groups were evaluated by SQAAQ item scores at each post baseline visit."|Baseline, Week 4 and Week 8|All randomized participants.|||units on a scale||Standard Deviation|Mean
2638036|NCT01777191|Secondary|Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment (sPGA)|"The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline."|Week 12|All randomized participants. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.|||percentage of participants|||Number
2638037|NCT01777191|Secondary|Percentage of Participants Achieving a ≥75%, ≥ 90% and 100% Improvement in Psoriasis Area and Severity Index (PASI): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index (PASI)|PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 or no Ps to 72 for the most severe disease. Participants achieving PASI 75, 90, or 100 are defined as having an improvement of at least 75%, 90%, or of 100%, respectively, in the PASI scores compared to baseline.|Week 12|All randomized participants. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
2638038|NCT01777191|Secondary|PK: AUC 0-tlast by Body Weight|AUC 0-tlast by body weight of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours. Body weight is defined by (Low: <80 kg, Medium: 80-100 kg, or High: >100 kg).|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.|||µg*day/mL||90% Confidence Interval|Geometric Mean
2638039|NCT01777191|Secondary|PK: Cmax by Body Weight|Cmax by body weight of Ixekizumab, after the 160 mg starting dose was administered on Day 0. Body weight is defined by (Low: <80 kilogram (kg), Medium: 80-100 kg, or High: >100 kg).|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.|||µg/mL||95% Confidence Interval|Geometric Mean
2638040|NCT01777191|Secondary|PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen)|AUC 0-tlast by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.|||µg*day/mL||90% Confidence Interval|Geometric Mean
2638041|NCT01777191|Secondary|PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen)|Cmax by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0.|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.|||µg/ml||90% Confidence Interval|Geometric Mean
2638042|NCT01777191|Primary|PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device|AUC 0-tlast by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.|||micrograms*day/milliliter (µg*day/mL)||90% Confidence Interval|Geometric Mean
2638043|NCT01777191|Primary|Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device|Cmax by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0.|Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)|All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.|||micrograms/milliliter (µg/mL)||90% Confidence Interval|Geometric Mean
2638044|NCT01777152|Secondary|Incidence of Laboratory Abnormalities|Number of patients who experienced a Grade 3 or higher laboratory toxicity|Up to 8.28 months|The Safety Analysis Set includes all patients who receive any amount of brentuximab vedotin or any component of CHOP. Treatment group will be determined using the actual treatment received, regardless of the randomization treatment assignment.|||Participants|||Count of Participants
2638045|NCT01777152|Secondary|Incidence of Adverse Events (AEs)||Up to 8.28 months|The Safety Analysis Set includes all patients who receive any amount of brentuximab vedotin or any component of CHOP. Treatment group will be determined using the actual treatment received, regardless of the randomization treatment assignment.|||Participants|||Count of Participants
2638046|NCT01777152|Secondary|Objective Response Rate Per IRF at End of Treatment|Number of patients who achieved CR or partial response (PR) at EOT|Up to 8.34 months|The ITT Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received.|||Participants|||Count of Participants
2638047|NCT01777152|Secondary|Overall Survival||Until death or study closure, up to 7 years post-treatment|||||||
2638048|NCT01777152|Secondary|Complete Remission Rate Per IRF at End of Treatment (EOT)|Number of patients who achieved complete remission (CR) at EOT|Up to 8.34 months|The ITT Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received.|||Participants|||Count of Participants
2638049|NCT01777152|Secondary|Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)||Up to 60 months|This analysis population includes only patients with systemic anaplastic large cell lymphoma (sALCL).|||months||Inter-Quartile Range|Median
2638050|NCT01777152|Primary|Progression-free Survival Per Independent Review Facility (IRF)||Up to 60 months|The Intent-to-Treat (ITT) Analysis Set includes all randomized patients. Patients are included in the treatment group assigned at randomization regardless of the actual treatment received.|||months||Inter-Quartile Range|Median
2638051|NCT01777139|Primary|Number of Participants With Resolution of Dermatologist-confirmed Abnormal Discoloration After Discontinuation of RTG|The skin examination included assessment of the skin around the eyes and the eye lids, lips, nails, and mucosa. Participants who enter the SFUCP who had on-treatment finding(s) of abnormal discoloration of skin, lips, nails or mucosa confirmed by a dermatologist, underwent assessments performed by a dermatologist at 6-monthly intervals.|Up to 1.4 years|All SFUCP Subjects|||Participants|||Count of Participants
2638052|NCT01777139|Primary|Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of RTG|The ophthalmologist/retina specialist determined the presence or absence of retinal and non-retinal ocular abnormalities. Retinal abnormalities included abnormalities in the macula and/or the peripheral retina. This analysis was performed on the All SFUCP Subjects population which comprised of all participants who enter the SFUCP.|Up to 1.4 years|All SFUCP Subjects|||Participants|||Count of Participants
2638053|NCT01777139|Primary|Percent Change From Baseline in 28-day Total POS Frequency|The 28-day total POS frequency was calculated as the number of total POS reported during the treatment phase, divided by the number of applicable days in the treatment phase, then multiplying this ratio by 28. In this formula, innumerable seizures were counted as 10 seizures and status epilepticus was counted as 1 seizure. As this was an OLE study, Baseline was defined by the parent study Baseline period. The percent change from Baseline was calculated as the 28-day total POS on-treatment frequency (during dosing in this study, not including the taper phase) minus the Baseline 28-day total POS frequency, with this difference being divided by the Baseline 28-day partial seizure rate, and the resulting quantity multiplied by 100. It was calculated as overall and by duration of exposure. Mean and SD were presented.|Baseline and up to 4 years|Safety Population|||Percent change||Standard Deviation|Mean
2638054|NCT01777139|Primary|Percentage of Responders to POS Frequency|A responder was defined as a participant experiencing a >=50 percent reduction in 28 day total POS frequency from Baseline. A responder rate was calculated overall and based on duration of exposure. As this was an OLE study, Baseline was defined by the parent study Baseline period. Percentage of responders were evaluated from study RTG114873 Day 1 through the last dosing day, excluding the Taper Phase.|Up to 4 years|Safety Population|||Percentage of responders|||Number
2638055|NCT01777139|Primary|Percentage of Participants With Decrease in Confrontational Visual Field From Initial Examination|Percentage of participants with decrease in confrontational visual field from initial examination were evaluated. Only abnormalities occurring on-treatment in study RTG114873 were presented.|Up to 4 years|Safety Population. Only those participants with data available at specific time point were analyzed.|||Percentage of participants|||Number
2638056|NCT01777139|Primary|Percentage of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination|Percentage of participants with a clinically significant decrease in visual acuity from initial examination were evaluated. Only abnormalities occurring on-treatment in study RTG114873 were presented.|Up to 4 years|Safety Population. Only those participants with data available at specific time point were analyzed.|||Percentage of participants|||Number
2638057|NCT01777139|Primary|Percentage of Participants With Dermatologist-confirmed Abnormal Discoloration|Percentage of participants with abnormal findings after skin examination (including the skin around the eyes and the eyelids, lips, nails, or mucosa) were evaluated.|Up to 4 years|Safety Population. Only those participants with data available at specific time point were analyzed.|||Percentage of participants|||Number
2638058|NCT01777139|Primary|Percentage of Participants With Pigmentation of Non-retinal Ocular Tissues|Percentage of participants with abnormal findings after eye examination were evaluated. Abnormalities detected on-treatment in study RTG114873 were presented. Pigmentation of non-retinal ocular tissues included pigmentation of the sclera and/or conjunctiva, cornea, iris and lens.|Up to 4 years|Safety Population. Only those participants with data available at specific time point were analyzed.|||Percentage of participants|||Number
2638059|NCT01777139|Primary|Percentage of Participants With Retinal Pigmentary Abnormalities|Percentage of participants with abnormal findings after eye examination were evaluated. Abnormalities detected on-treatment in study RTG114873 were presented. Retinal pigmentary abnormalities included abnormalities in the macula, peripheral retina and unspecified location.|Up to 4 years|Safety Population. Only those participants with data available at specific time point were analyzed.|||Percentage of participants|||Number
2638060|NCT01777139|Primary|Number of Participants Who Discontinued From RTG|The number of participants who discontinued from RTG treatment has been presented.|Up to 4 years|Safety Population|||Participants|||Count of Participants
2638061|NCT01777139|Primary|Number of Participants With Suicidal Ideation or Behavior During Treatment Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)|"Number of participants with suicidal ideation or behavior during treatment were assessed using the C-SSRS score scale. It is a brief questionnaire designed to assess severity and change in suicidality by integrating both behavior and ideation using a semi-structured interview to probe participant responses. It consists of an assessment of suicidal ideation (ranging from desire to be dead to active suicidal ideation with specific plan and intent) and an assessment of suicidal behavior (ranging from preparatory acts or behavior to completed suicide)."|Up to 4 years|Safety Population|||Participants|||Count of Participants
2638062|NCT01777139|Primary|Change From Baseline in Post-void Residual (PVR) Bladder Ultrasound Volumes|The PVR bladder ultrasound was used to assess the effects of RTG on bladder function. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.|Baseline and up to 4 years|Safety Population|||Milliliter (mL)||Standard Deviation|Mean
2638073|NCT01777139|Primary|Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD)|Blood samples collected from participants to evaluate change from Baseline in clinical chemistry parameters included ALT, Alk. phosph., AST,CK, GGT and LD. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.|Baseline and up to 4 years|Safety Population|||International unit per liter (IU/L)||Standard Deviation|Mean
2638063|NCT01777139|Primary|Change From Baseline in American Urological Association (AUA) Symptom Scale Scores|The effect of RTG on bladder function was assessed using AUA symptom index. It is a 7-item Likert-scored scale with seven questions, each with six potential responses. Responses to each of 7 questions were scored from 0 (no symptom at all) to 5 (almost always symptoms present) which were summmed to get total possible score ranging from 0 to 35 with higher scores indicating worse symptom severity. The total score for all questions was classified as mild (0-7), moderate (8-19) or severe (>19). Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 4 years|Safety Population|||Scores on a scale||Standard Deviation|Mean
2638064|NCT01777139|Primary|Change From Baseline in Urine Creatinine Concentration|Urine samples were collected from participants to evaluate change from Baseline in Urine creatinine concentration. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.|Baseline and up to 4 years|Safety Population|||µmol/L||Standard Deviation|Mean
2638065|NCT01777139|Primary|Potential of Hydrogen (pH) of Urine at Indicated Time Points|Urine Samples were collected to analyze pH. pH is a measure of hydrogen ion concentration and used to determine the acidity or alkalinity of urine. pH scale ranges from 0 to 14. A neutral pH is 7.0. The higher number indicates the more basic (alkaline) nature of urine and lower the number indicates the more acidic urine. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to 4 years|Safety Population|||Scores on a scale||Standard Deviation|Mean
2638066|NCT01777139|Primary|Specific Gravity of Urine at Indicated Time Points|Urine samples were collected to analyze specific gravity of urine. Specific gravity, is a measure of urine concentration and is measured using a chemical test. Specific gravity measurements provide a comparison of the amount of substances dissolved in urine as compared to pure water. If there were no solutes present, the specific gravity of urine would be 1.000 the same as pure water. Specific gravity between 1.002 and 1.035 could be considered as normal. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to 4 years|Safety Population|||Kilograms per meter^3 (Kg/m^3)||Standard Deviation|Mean
2638067|NCT01777139|Primary|Number of Participants With Abnormal Urinalysis Values (Categorical Data)|Urine samples were collected from participants to analyze presence of abnormal urinalysis parameters including glucose, ketones, RBC, WBC, occult blood and protein. Abnormal urinalysis values have been presented for all parameters. Only those participants with data available at specific time points were analyzed (represented by n= X in the category titles).|Up to 4 years|Safety Population|||Participants|||Count of Participants
2638068|NCT01777139|Primary|Change From Baseline in Urine Albumin/Creatinine Ratio|Urine samples were collected from participants to evaluate change from Baseline in urine albumin/creatinine ratio. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated. NA indicates data was not available as standard deviation could not be calculated for single participant.|Baseline and up to 4 years|Safety Population|||Ratio||Standard Deviation|Mean
2638069|NCT01777139|Primary|Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid|Blood samples were collected from participants to evaluate change from Baseline in creatinine, direct bilirubin, total bilirubin, and uric acid. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.|Baseline and up to 4 years|Safety Population|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2638070|NCT01777139|Primary|Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN|Blood samples were collected from participants to evaluate change from Baseline in calcium, CO2 content/Bicarb, chloride, glucose, magnesium, potassium, sodium, and urea/BUN. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.|Baseline and up to 4 years|Safety Population|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2638071|NCT01777139|Primary|Change From Baseline in Blood Urea Nitrogen (BUN)/Creatinine Ratio|Blood samples were collected from participants to evaluate change from Baseline in BUN/creatinine. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.|Baseline and up to 4 years|Safety Population|||Ratio||Standard Deviation|Mean
2638072|NCT01777139|Primary|Change From Baseline in Albumin and Total Protein|Blood samples were collected from participants to evaluate change from Baseline in albumin and total protein. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.|Baseline and up to 4 years|Safety Population|||G/L||Standard Deviation|Mean
2638111|NCT01776645|Primary|Change in Brief Pain Inventory|Intensity - pain severity as measured by a 0 to 10 visual analogue scale. 0 = no pain, 10 = worst pain imaginable|Baseline and end of 9-week treatment protocol|2 participants excluded from analysis: 1 did not complete the final questionnaire battery, 1 reported no pain at baseline and thus could not be included as a patient with chronic pain|||units on a scale||Standard Deviation|Mean
2638074|NCT01777139|Primary|Change From Baseline in Red Cell Distribution Width (RDW)|Blood samples were collected from participants to evaluate change from Baseline in RDW. RDW is a parameter that measures variation in red blood cell size or red blood cell volume. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.|Baseline and up to 4 years|Safety Population|||Percentage of width||Standard Deviation|Mean
2638075|NCT01777139|Primary|Change From Baseline in Red Blood Cell (RBC) Count|Blood samples were collected from participants to evaluate change from Baseline in RBC count. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.|Baseline and up to 4 years|Safety Population|||Tetra unit per liter (TI/L)||Standard Deviation|Mean
2638076|NCT01777139|Primary|Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV)|Blood samples were collected from participants to evaluate change from Baseline in MCV and MPV levels. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.|Baseline and up to 4 years|Safety Population|||Femtoliter (fL)||Standard Deviation|Mean
2638077|NCT01777139|Primary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Level|Blood samples were collected from participants to evaluate change from Baseline in MCH levels. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.|Baseline and up to 4 years|Safety Population|||Picogram (Pg)||Standard Deviation|Mean
2638078|NCT01777139|Primary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)|Blood samples were collected from participants to evaluate change from Baseline in hemoglobin and MCHC levels. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.|Baseline and up to 4 years|Safety Population|||Gram per Liter (G/L)||Standard Deviation|Mean
2638079|NCT01777139|Primary|Change From Baseline in Hematocrit|Blood samples were collected from participants for evaluation of hematocrit. Hematocrit is a ratio of red blood cells to the total volume of blood. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.|Baseline and up to 4 years|Safety Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
2638080|NCT01777139|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC)|Blood samples were collected from participants for evaluation of change from Baseline in hematology parameters including basophils, eosinophils, lymphocytes,monocytes, platelet count, total neutrophils, and WBC. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were calculated.|Baseline and up to 4 years|Safety Population|||Giga unit per liter (GI/L)||Standard Deviation|Mean
2638081|NCT01777139|Primary|Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters|Single measurements of 12-lead ECGs were obtained in a supine position after at least 10 minutes of rest using an ECG machine that automatically calculates the heart rate (HR) as beats per minute (bpm) and measures PR, QRS, Bazett's correction QT interval (QTcB) and Friedericia's correction QT interval (QTcF) in milliseconds (msec). A Baseline assessment in this OLE study was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Number of participants with PCC values of ECG parameters at any Post-Baseline visit were presented. For the 'Any Post Baseline' value, only the worst case finding was counted for each participant.|Baseline and up to 4 years|Safety Population|||Participants|||Count of Participants
2638082|NCT01777139|Primary|Number of Participants With PCC Values of Change From Baseline for Body Weight|Body weight of participants were measured as a measure of safety. PCC range for body weight was increase or decrease of >=7 percent. A Baseline assessment in this OLE study was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Number of participants with PCC values of body weight at any Post-Baseline visit were presented.|Baseline and up to 4 years|Safety Population|||Participants|||Count of Participants
2638083|NCT01777139|Primary|Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline for Vital Signs|The vital signs were evaluated as per PCC Criteria. The vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR). The vital signs were measured in a seated position after 5 minutes of rest. PCC range for DBP was increase or decrease of >=20, for SBP was increase or decrease of >=15 and for heart rate was increase or decrease of >=15. A Baseline assessment in this OLE study was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Number of participants with vital sign values of PCC at any Post-Baseline visit were presented.|Baseline and up to 4 years|Safety Population|||Participants|||Count of Participants
2638084|NCT01777139|Primary|Percentage of Participants With TEAEs Leading to Study Discontinuation|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE refers to an AE for which the onset was on or after the date of the first RTG dose in this study and on or before 30 days after the last RTG dose date. Percentage of participants with TEAEs leading to study discontinuation were presented.|Up to 4 years|Safety Population|||Percentage of Participants|||Number
2638085|NCT01777139|Primary|Number of Participants With Treatment Emergent (TE) Serious Adverse Events (SAEs) and Non-SAEs|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function is SAE. TEAE refers to an AE for which the onset was on or after the date of the first RTG dose in this study and on or before 30 days after the last RTG dose date. AEs that started in the parent study that worsened in this study were also considered as TEAEs. Safety population comprised of participants who take at least 1 dose of study medication after they have enrolled into this OLE study. Number of participants with TE-SAEs and non-SAEs (with incidence >= 5%) have been presented.|Up to 4 years|Safety Population|||Participants|||Count of Participants
2638086|NCT01777126|Secondary|Severity Grade of Postoperative Complications.|Severity grade of postoperative complications (POCs) was compared between the two groups. The severity grade of POCs were classified using the Clavien-Dindo Classification. Per patient, multiple complications are possible.|30 days postoperative||||number of POCs per severity grade|||Number
2638087|NCT01777126|Secondary|The Type of Postoperative Complications.|The type of postoperative complications (POCs) were compared between the two groups. The type of POCs were classified using the Clavien-Dindo Classification. Herein POCs were classified into 8 categories (1. Infection, 2. Fistula/leak, 3. Bleeding/hematoma, 4. Gastrointestinal, 5. Cardiopulmonary, 6. Neurologic, 7. pain and 8. Other) and stratified by their severity grade (Table 2). Per patient, multiple complications are possible.|30 days postoperative||||number per type of POC|||Number
2638088|NCT01777126|Secondary|Patients With a Catheter Related Bloodstream Infection|Patients with a catheter related bloodstream infection were compared between the two groups|30 days postoperative||||participants|||Number
2638089|NCT01777126|Secondary|The Number of Postoperative Complications Per Patient.|The number of postoperative complications per patient was compared between the two groups.|30 days postoperative||||number of postoperative complications||Inter-Quartile Range|Median
2638090|NCT01777126|Secondary|Patients With One or More Postoperative Complication.|Number of patients with one or more postoperative complication were compared betweent the two groups.|30 days postoperative||||participants|||Number
2638091|NCT01777126|Secondary|The Time to Resumption of Full Diet.|The time to resumption of full diet between the two groups was compared.|30 days postoperative||||day||Inter-Quartile Range|Median
2638092|NCT01777126|Secondary|Number of Administered PN|Number of administered PN per group|30 days postoperative||||number of PN|||Number
2638093|NCT01777126|Secondary|Successful Implementation Rate of the ONP in the Experimental Group|Successful implementation of the ONP was achieved if the patient followed the protocol and did not need PN.|30 days postoperative|The number of patients with successful implementation of the ONP in the experimental group.|||participants|||Number
2638094|NCT01777126|Primary|the Postoperative Length of Stay|The primary outcome measure was the interval from surgery to discharge. Discharge means that the patient returns to his home.|one month after surgery|Primary outcome measure was interval from surgery to discharge. Discharge means that the patient returns back to his home and not to a rehabilitation center.|||day||Inter-Quartile Range|Median
2638095|NCT01776723|Secondary|Duration of Response in Days|Phase II - To determine the duration of response achieved as in secondary endpoint one. The duration of response is measured from the time measurement criteria are met for major or complete platelet response (which ever is first recorded) until the first date that disease progression defined by the bone marrow response outlined above, progression/relapse following a CR, marrow CR or PR, or progressions/relapse following hematological improvement (HI) as outlined above.|3.5 years||||days||Full Range|Mean
2638096|NCT01776723|Secondary|Median Overall Survival (OS)|Phase II - To determine the median overall survival.|Up to 2 years|All participants who received ruxolitinib therapy|||months||95% Confidence Interval|Median
2638097|NCT01776723|Secondary|Percentage of Participants With Acute Myeloid Leukemia (AML) Transformation|Phase II - To determine the time to AML transformation of participants on Ruxolitinib. Acute myeloid leukemia (AML) transformation according to World Health Organization (WHO) criteria. CMML-1: peripheral blood <5% blasts, bone marrow <10% myeloblast. CMML-2: peripheral blood <19 percent blasts persistent monocytosis >1000/ul +/- cytopenias Leukocytosis frequent, bone marrow <19 percent blasts >10% dysplasia in affected lineage, Auer Rods.|Up to 2 years||||percentage of patients|||Number
2638098|NCT01776723|Primary|Occurrence of Clinical Response|Phase II - Proportion of participants achieving clinical benefit defined as hematologic improvement, complete remission (CR), partial remission (PR), marrow complete remission (Marrow CR) or stable disease (SD) by the International Working Group (IWG) 2006 criteria. Erythroid Response for pretreatment hemoglobin < 11 g/dl; Platelet response for subjects with a pre-treatment platelet count < 50 x 10^9/L; Neutrophil response with pretreatment absolute neutrophil count (ANC) < 1 x 10^9/L.|Up to 2 years|All participants who received ruxolitinib therapy|||participants|||Number
2638099|NCT01776723|Primary|The Maximum Tolerated Dose (MTD) of Ruxolitinib for the Treatment of Myelomonocytic Leukemia (CMML)|Phase I - The MTD is defined as the highest dose where less than 33% of participants experience a drug related predefined dose limited toxicity (DLT). Dose-limiting toxicity (DLT) is defined as any grade 4 hematologic toxicity and any grade 3 or greater non-hematologic toxicity except nausea that is controlled by antiemetic therapy based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 3 metabolic/electrolyte abnormalities that are not clinically significant, and are adequately controlled within 72 hours are not to be considered a DLT.|17 weeks||||mg|||Number
2651438|NCT01662102|Secondary|Time to Next Anti-Lymphoma Treatment (TTNLT)|TTNLT is defined as the time from randomization to the first introduction of any new anti lymphoma regimen.|Up to 7 years|||||||
2638112|NCT01776632|Secondary|Waist Circumference|Change from baseline in waist circumference|assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported|A total of 361 participants (178 physical activity condition, 183 cancer screening condition) had valid waist circumference data at 12-month follow-up measures. Those without valid data (incomplete anthropometrics, etc) were not included in the analysis.|||cm||Standard Error|Mean
2638113|NCT01776632|Secondary|Body Mass Index (BMI)|Change from baseline in body mass index (BMI)|assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported|A total of 361 participants (178 physical activity condition, 183 cancer screening condition) had valid BMI data at 12-month follow-up measures. Those without valid data (incomplete anthrometric measures, etc) were not included in the analysis.|||kg/m2||Standard Error|Mean
2638114|NCT01776632|Primary|Self-report Leisure-time MVPA|Change from baseline in self-reported leisure-time moderate-to-vigorous physical activity|assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported|A total of 375 participants (187 physical activity condition, 188 cancer screening condition) had valid self-report leisure-time data at 12-month follow-up measures. Those without valid data (incomplete data, etc) were not included in the analysis.|||minutes/week||Standard Deviation|Mean
2638115|NCT01776632|Primary|Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA)|Change from baseline in moderate-to-vigorous physical activity as assessed by accelerometer|assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported|A total of 369 participants (183 physical activity condition, 186 cancer screening condition) had valid accelerometer data at 12-month follow-up measures. Those without valid data (unmet wear time, lost device, etc) were not included in the analysis.|||minutes/week||Standard Deviation|Mean
2638116|NCT01776554|Secondary|The Percentages Of Subjects Aged 9 to <18 Years, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentages of subjects aged 9 to <18 years achieving seroconversion in HI titers, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.~Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.~The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion (at day 43) is >40%."|Day 22, day 43 and day 387|Analysis was done the FAS.|||Percentages of subjects||95% Confidence Interval|Number
2638117|NCT01776554|Secondary|The Percentages Of Subjects Aged 3 to <9 Years, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentages of subjects aged 3 to <9 years achieving seroconversion in HI titers, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.~Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.~The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion (at day 43) is >40%."|Day 22, day 43 and day 387|Analysis was done on FAS.|||Percentages of subjects||95% Confidence Interval|Number
2638118|NCT01776554|Secondary|The Percentages Of Subjects Aged 6 to <36 Months, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentages of subjects aged 6 to <36 months achieving seroconversion in HI titers, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.~Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.~The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion (at day 43) is >40%."|Day 22, day 43 and day 387|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
2638119|NCT01776554|Secondary|Percentages Of Subjects Aged 9 to <18 Years, With HI Titers ≥40 Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentage of subjects aged 9 to <18 years, achieving HI titers ≥40, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c according to the CHMP criterion.~European Licensure (CHMP) criterion is met if the percentage of subjects achieving (at day 43) HI titers ≥40 is >70%."|Day 1, day 22, day 43 and day 387.|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
2638120|NCT01776554|Secondary|Percentages Of Subjects Aged 3 to <9 Years, With HI Titers ≥40 Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentage of subjects aged 3 to <9 years, achieving HI titers ≥40, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c according to the CHMP criterion.~European Licensure (CHMP) criterion is met if the percentage of subjects achieving (at day 43) HI titers ≥40 is >70%."|Day 1, day 22, day 43 and day 387.|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
2638121|NCT01776554|Secondary|Percentages Of Subjects Aged 6 to <36 Months, With HI Titers ≥40 Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentage of subjects aged 6 to <36 months, achieving HI titers ≥40, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c according to the CHMP criterion.~European Licensure (CHMP) criterion is met if the percentage of subjects achieving (at day 43) HI titers ≥40 is >70%."|Day 1, day 22, day 43 and day 387.|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
2638131|NCT01776554|Primary|The Percentages Of Subjects Aged 9 to <18 Years, Achieving HI Titers ≥40 Against A/H5N1 Strain|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects aged 9 to <18 years, achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the CBER criterion.~As there is no CBER criteria defined for children, immunogenicity was evaluated using CBER criterion applicable for adults (18-64 years).~CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on FAS.|||Percentages of subjects||95% Confidence Interval|Number
2638122|NCT01776554|Secondary|Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 9 to <18 Years.|"Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination with either low dose or high dose of aH5N1c in subjects aged 9 to <18 years is reported.~As no CHMP criteria are established for the pediatric population, criteria given for subjects 18-60 years of age were applied.~The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criteria if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.5."|Day 1, day 22, day 43 and day 387|Analysis was done on the FAS.|||Ratio||95% Confidence Interval|Geometric Mean
2638123|NCT01776554|Secondary|Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 3 to <9 Years.|"Immunogenicity was measured as geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination with either low dose or high dose of aH5N1c in subjects aged 3 to <9 years is reported.~As no CHMP criteria are established for the pediatric population, criteria given for subjects 18-60 years of age were applied.~The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criteria if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.5."|Day 1, day 22, day 43 and day 387|Analysis was done on the FAS.|||Ratio||95% Confidence Interval|Geometric Mean
2638124|NCT01776554|Secondary|Geometric Mean Ratios Against A/H5N1 Strain Following 2-Dose Vaccination Schedule Of Either Low Dose Or High Dose AH5N1c Vaccine in Subjects Aged 6 to <36 Months.|"Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination with either low dose or high dose of aH5N1c in subjects aged 6 to <36 months is reported.~The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criteria if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.5.~As no CHMP criteria are established for the pediatric population, criteria given for subjects 18-60 years of age were applied."|Day 1, day 22, day 43 and day 387|Analysis was done on the FAS.|||Ratio||95% Confidence Interval|Geometric Mean
2638125|NCT01776554|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination|Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with either low or high dose of aH5N1c vaccine.|Any unsolicited AEs - day 1 through day 22 after any vaccination; SAEs, NOCDs. medically attended AEs, AESIs, AEs leading to study withdrawal- day 1 to day 387|Analysis was done on the safety dataset.|||Number of subjects|||Number
2638126|NCT01776554|Primary|Number of Subjects (≥6 Years - 17 Years) Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination|Safety was assessed using the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.|From day 1 through day 7 after any vaccination.|Analysis was done on the safety dataset.|||Number of subjects|||Number
2638127|NCT01776554|Primary|Number of Subjects (6 Month - <6 Years) Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination|Safety was assessed using the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.|From day 1 through day 7 after each vaccination.|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
2638128|NCT01776554|Primary|The Percentages Of Subjects Aged 9 to <18 Years, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was measured in terms of the percentages of subjects aged 9 to <18 years, achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criteria.~Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.~CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%."|Three weeks after 2nd vaccination (day 43)|This analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
2638129|NCT01776554|Primary|The Percentages Of Subjects Aged 3 to <9 Years, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was measured in terms of the percentages of subjects aged 3 to <9 years, achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criteria.~Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.~CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on FAS.|||Percentages of subjects||95% Confidence Interval|Number
2638130|NCT01776554|Primary|The Percentages Of Subjects Aged 6 to <36 Months, Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was measured in terms of the percentages of subjects aged 6 to <36 months, achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criteria.~Seroconversion is defined as the percentages of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, and a minimum four-fold rise in postvaccination HI antibody titer.~CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%."|Three weeks after 2nd vaccination (day 43)|Analysis was done was FAS.|||Percentages of subjects||95% Confidence Interval|Number
2638419|NCT01774253|Primary|Number of Days Participants Experienced Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions.|5 years||||Days||Full Range|Median
2638132|NCT01776554|Primary|The Percentages Of Subjects Aged 3 to <9 Years, Achieving HI Titers ≥40 Against A/H5N1 Strain|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects aged 3 to <9 years, achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the CBER criterion.~As there is no CBER criteria defined for children, immunogenicity was evaluated using CBER criterion applicable for adults (18-64 years).~CBER criterion is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on FAS.|||Percentages of subjects||95% Confidence Interval|Number
2638133|NCT01776554|Primary|The Percentages Of Subjects Aged 6 to <36 Months, Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects aged 6 to <36 months, achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion.~As there is no CBER criteria defined for children, immunogenicity was evaluated using CBER criterion applicable for adults (18-64 years).~CBER criterion is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on the Full Analysis Set (FAS) i.e., the subjects who actually received at least one dose of study vaccination and provided at least one evaluable serum sample both before (baseline) and after vaccination.|||Percentages of subjects||95% Confidence Interval|Number
2638134|NCT01776541|Secondary|Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.|"Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.~Seroconversion is defined as: a) for subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or b) for subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.~The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion (at day 43) is >40%."|Day 22, day 43 and day 387|Analysis was done on the FAS set.|||Percentages of subjects||95% Confidence Interval|Number
2638135|NCT01776541|Secondary|Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain.|"Immunogenicity was assessed in terms of percentage of subjects achieving HI titers ≥40, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c according to the CHMP criterion.~European Licensure (CHMP) criterion is met if the percentage of subjects achieving (at day 43) HI titers ≥40 is >70%."|Day 1, day 22, day 43 and day 387|Analysis was done on the FAS set.|||Percentages of subjects||95% Confidence Interval|Number
2638136|NCT01776541|Secondary|Geometric Mean Ratios Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.|"Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, 3 weeks after first vaccination, 3 weeks after second vaccination and 12 months after second vaccination of either low dose or high dose of aH5N1c is reported.~The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criterion if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.5 for subjects 18-60 years of age."|Day 1; day 22; day 43 and day 387|Analysis was done on the FAS set.|||Ratio||95% Confidence Interval|Geometric Mean
2638137|NCT01776541|Primary|Number of Subjects Reporting Unsolicited AEs After Any Vaccination.|Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with either low or high dose of aH5N1c vaccine.|Any unsolicited AEs - day 1 through day 22 after any vaccination. SAEs, NOCDs. medically attended AEs, AESIs, AEs leading to study withdrawal- day 1 to day 387|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
2638138|NCT01776541|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AE), After Any Vaccination.|Safety was assessed using the number of subjects who reported solicited local and systemic AEs following vaccination with either low or high dose of aH5N1c vaccine.|From day 1 through day 7 after any vaccination.|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
2638139|NCT01776541|Primary|Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.|"Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion.~Seroconversion is defined as either a) in subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or b) in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.~CBER criterion for the adult population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 40%."|Three weeks after 2nd vaccination (day 43)|This analysis was done on the FAS population.|||Percentages of subjects||95% Confidence Interval|Number
2638140|NCT01776541|Primary|Percentages Of Subjects Achieving Hemagglutinin Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion.~CBER criterion for the adult population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 70%."|Three weeks after 2nd vaccination (day 43)|Analysis was done on the Full Analysis Set (FAS) i.e., the subjects who actually receive at least one dose of study vaccination and provide at least one evaluable serum sample both before (baseline) and after vaccination.|||Percentages of subjects||95% Confidence Interval|Number
2638420|NCT01774149|Other Pre-specified|Empowerment|Diabetes Empowerment Scale-Short Form (DES-SF) will be used to assess empowerment at the start of the study (week 1 post-enrollment) and during week 12 of intervention.|Up to 12 weeks post-enrollment.|||||||
2638141|NCT01776424|Secondary|All-cause Mortality|Count of participants and time from randomization to death by all cause were evaluated. Hazard ratios were calculated and reported as statistical analysis.|For each participants, death by any cause after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.|ITT Analysis Set included all randomized subjects|||Participants|||Count of Participants
2638142|NCT01776424|Secondary|The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) Death|Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.|For each participant, the first occurrence of MI, ischemic stroke, ALI, or CV death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.|ITT Analysis Set included all randomized subjects|||Participants|||Count of Participants
2638143|NCT01776424|Secondary|The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death|Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CHD death were evaluated. Hazard ratios were calculated and reported as statistical analysis.|For each participant, the first occurrence of MI, ALI, or CHD death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.|ITT Analysis Set included all randomized subjects|||Participants|||Count of Participants
2638144|NCT01776424|Primary|The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria|"Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day).~Count of participants and time from randomization to the first occurrence of the primary safety outcome major bleeding were evaluated. Hazard ratios were calculated and reported as statistical analysis."|For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.|ITT Analysis Set included all randomized subjects|||Participants|||Count of Participants
2638145|NCT01776424|Primary|The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death|Count of participants and time from randomization to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.|For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.|ITT Analysis Set included all randomized subjects|||Participants|||Count of Participants
2638146|NCT01776268|Primary|Concentration of APPs After Oral Priming|Saliva will be sampled 24-48 hours after the 5-days of oral priming is completed. Investigators are assessing saliva for a change in the concentration of antimicrobial proteins.|days 7-9 of life||||femtomole (fmol)||Inter-Quartile Range|Mean
2638147|NCT01776268|Primary|Concentration of APPs Before Oral Priming|Saliva will be sampled on day 1-2 of life prior to oral priming. Investigators are assessing saliva for a change in the concentration of antimicrobial proteins.|days 1-2 of life||||femtomole (fmol)||Inter-Quartile Range|Mean
2638148|NCT01776008|Other Pre-specified|The Pharmacodynamic Effect of Akt Inhibitor MK2206 in Combination With Anastrozole on the PI3K Pathway Activities, Assessed by Phosphoroproteomics and Immunohistochemistry Analysis on Serial Tumor Biopsies||Up to 3 weeks following the last dose of Akt inhibitor MK-2206|Data was not collected.||||||
2638149|NCT01776008|Other Pre-specified|Serum Estradiol Levels||At baseline, following 4 weeks of anastrozole alone, day 1 of course 3, and at pre-surgery|Data was not collected.||||||
2638150|NCT01776008|Other Pre-specified|Proportion of Patients Whose Ki67 Values is at Most 10%|A 95% binomial confidence intervals will be constructed for the true proportion of patients whose pre Akt inhibitor MK2206 ki67 value is at most 10% as well as for the true proportion of patients with a C1D17 Ki67 value that is at most 10% among those patients whose pre Akt inhibitor MK2206 Ki67 was more than 10%.|From 2 weeks of combination therapy with Akt inhibitor MK2206 and anastrozole (day 17 of course 1) to after 4 weeks of treatment with anastrozole alone|Data was not collected.||||||
2638151|NCT01776008|Other Pre-specified|Percent Change in the Apoptotic Index||From 2 weeks of combination therapy with Akt inhibitor MK2206 and anastrozole (day 17 of course 1) to after 4 weeks of treatment with anastrozole alone|Data was not collected.||||||
2638152|NCT01776008|Other Pre-specified|Change in Ki67 Levels||From 2 weeks of combination therapy with Akt inhibitor MK2206 and anastrozole (day 17 of course 1) to after 4 weeks of treatment with anastrozole alone|Data was not collected||||||
2638153|NCT01776008|Secondary|Radiological Response Rate|The Clinical response rate is estimated by the number of patients whose disease meets the WHO criteria of complete or partial response based on radiographic evaluation (mammogram or ultrasound) divided by the total number of eligible patients. Complete Response (CR) is defined as the disappearance of all known disease based on measurements taken at the completion of neo-adjuvant therapy. Partial Response (PR) is defined as a 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size) between the pre-treatment measurements and the measurements taken at the completion of neo-adjuvant therapy. A ninety percent confidence interval for the true clinical response rate will be calculated using the Duffy-Santer approach.|Baseline and completion of cycle 4 (28 day cycles)|Due to missing pre-surgical scans, this endpoint could not be evaluated.||||||
2638219|NCT01775670|Secondary|PROMIS Pain - Interference|A computerized assessment of pain interference measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is worse than the average and a T score less than 50 is better than the average.|At Enrollment||||T score||Standard Deviation|Mean
2638154|NCT01776008|Secondary|Incidence of Adverse Events, Based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. For this endpoint, we are reporting the number of patients that reported a grade 3 or higher graded adverse event during neoadjuvent treatment. A complete list of all reported adverse events is in the Adverse Events section of the report.|Baseline to end of Cycle 4 (28 day cycles)|All patients that registered and began neoadjuvant treatment were included in this analysis.|||Participants|||Count of Participants
2638155|NCT01776008|Secondary|Clinical Response Rate|The Clinical response rate is estimated by the number of patients whose disease meets the WHO criteria of complete or partial response based on physical examination divided by the total number of eligible patients. Complete Response (CR) is defined as the disappearance of all known disease based on measurements taken at the completion of neo-adjuvant therapy. Partial Response (PR) is defined as a 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size) between the pre-treatment measurements and the measurements taken at the completion of neo-adjuvant therapy. A ninety percent confidence interval for the true clinical response rate will be calculated using the Duffy-Santer approach.|Baseline to end of Cycle 4 (28 day cycles)|Due to missing bi-dimensional measurements, clinical response could not be determined.||||||
2638156|NCT01776008|Primary|Pathological Complete Response Rate|Any woman whose Ki67 value ≤10% on cycle 1 day 17 of combination treatment who does not receive alternative treatment prior to surgery and has no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary lymph nodes is considered to have a pathological complete response (pCR). A ninety percent confidence interval for the true pathologic complete response rate will be calculated using the Duffy-Santer approach.|At time of surgery (up to 3 weeks after 4, 28-day cycles)|All patients beginning protocol therapy and evaluable for primary endpoint were included in this analysis.|||participants|||Number
2638157|NCT01775995|Other Pre-specified|Pain Sensitivity to Experimental Thermal Stimuli|Pain sensitivity to thermal stimuli was assessed using standard psychophysical procedures. Thermal stimuli, ranging from 43 to 49oC, were applied to the thenar eminence of the right hand. Each stimulus was rated on two separate, validated 0-20 category-ratio scales assessing pain intensity and unpleasantness.|0, 8, 26 weeks|||||||
2638158|NCT01775995|Other Pre-specified|Economic Outcomes|"Cost of medications, health care utilization, motor vehicle accidents (MVAs), and lost productivity were assessed.~Medications (past month - self-report, verified against medication bottles): opioids (Timeline Followback), other medications (average daily use); costs for the past 6 months were calculated. Health care utilization (past 6 months): self-reported number of outpatient (medical, mental health, urgent care) and emergency department visits; number of inpatient days. Lost productivity (past 6 months): self-report number of missed work and leisure days. MVAs (past 6 months): self-report number of MVAs.~Cost Sources: Medications - rxpricequotes.com (primary), drugs.com (secondary), walgreens.com (tertiary). Health care utilization - WI Price Point System, Medical Expenditure Panel Survey. MVAs - National Safety Council. Lost productivity - U.S. Dept of Labor (average daily wage for a WI worker for work days; 8-hours of the federal minimum wage for lost leisure day)."|From enrollment to 26 week follow-up (6 months)|One meditation-CBT participant did not provide data at 8-week follow-up; two participants (one meditation-CBT, one control) did not provide data at 26-week follow-up. All 35 participants were included in the analysis; missing participant data was imputed based on existing data for the given participant.|||dollars||Standard Deviation|Mean
2638159|NCT01775995|Other Pre-specified|Economic Outcomes|"Cost of medications, health care utilization, motor vehicle accidents (MVAs), and lost productivity were assessed.~Medications (past month - self-report, verified against medication bottles): opioids (Timeline Followback), other medications (average daily use); costs for the past 6 months were calculated. Health care utilization (past 6 months): self-reported number of outpatient (medical, mental health, urgent care) and emergency department visits; number of inpatient days. Lost productivity (past 6 months): self-report number of missed work and leisure days. MVAs (past 6 months): self-report number of MVAs.~Cost Sources: Medications - rxpricequotes.com (primary), drugs.com (secondary), walgreens.com (tertiary). Health care utilization - WI Price Point System, Medical Expenditure Panel Survey. MVAs - National Safety Council. Lost productivity - U.S. Dept of Labor (average daily wage for a WI worker for work days; 8-hours of the federal minimum wage for lost leisure day)."|6 months prior to baseline, to baseline (enrollment)||||dollars||Standard Deviation|Mean
2638160|NCT01775995|Other Pre-specified|C-Reactive Protein|"Serum levels of C-reactive protein were used to assess the potential biological effects of the intervention. Normal values for C-reactive protein fall between 0 and 1 mg/dL; higher levels may indicate inflammatory or infectious processes.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure)."|baseline to 26 weeks|Six Meditation-CBT participants and one Wait-list Control participant did not provide biological data at 26 week follow-up. Results for this measure are based on the number of participants analyzed.|||mg/dL||95% Confidence Interval|Mean
2638161|NCT01775995|Other Pre-specified|C-Reactive Protein|"Serum levels of C-reactive protein were used to assess the potential biological effects of the intervention. Normal values for C-reactive protein fall between 0 and 1 mg/dL; higher levels may indicate inflammatory or infectious processes.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure)."|baseline to 8 weeks|Three Meditation-CBT participants did not provide biological data at 8 week follow-up. Results for this measure are based on the number of participants analyzed.|||mg/dL||95% Confidence Interval|Mean
2638162|NCT01775995|Other Pre-specified|Emotion Regulation Difficulty|"Emotion regulation difficulty was assessed using the 36-item Difficulties in Emotion Regulation Scale (DERS). This measure's total score (36-180) reflects the severity of emotion regulation difficulty (no timeframe specified).~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased emotion regulation difficulty and negative values indicating decreased emotion regulation difficulty."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
2638881|NCT01769443|Secondary|Change in Calculated PRA (cPRA) From Wait Listing to Transplantation||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
2638163|NCT01775995|Other Pre-specified|Emotion Regulation Difficulty|"Emotion regulation difficulty was assessed using the 36-item Difficulties in Emotion Regulation Scale (DERS). This measure's total score (36-180) reflects the severity of emotion regulation difficulty (no timeframe specified).~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased emotion regulation difficulty and negative values indicating decreased emotion regulation difficulty."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
2638164|NCT01775995|Other Pre-specified|Anxiety Symptom Severity|"Anxiety symptom severity was assessed using the anxiety subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 10-item Anxiety subscale (0-40) reflects the degree of severity of distress from anxiety symptoms during the past 7 days.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of distress from anxiety symptoms and negative values indicating decreased levels of distress from anxiety symptoms."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
2638165|NCT01775995|Other Pre-specified|Anxiety Symptom Severity|"Anxiety symptom severity was assessed using the anxiety subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 10-item Anxiety subscale (0-40) reflects the degree of severity of distress from anxiety symptoms during the past 7 days.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of distress from anxiety symptoms and negative values indicating decreased levels of distress from anxiety symptoms."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
2638166|NCT01775995|Other Pre-specified|Depression Symptom Severity|"Depression symptom severity was assessed using the depression subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 13-item Depression subscale (0-52) reflects the degree of severity of distress from depression symptoms during the past 7 days.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of distress from depression symptoms and negative values indicating decreased levels of distress from depression symptoms."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
2638167|NCT01775995|Other Pre-specified|Depression Symptom Severity|"Depression symptom severity was assessed using the depression subscale of the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's 13-item Depression subscale (0-52) reflects the degree of severity of distress from depression symptoms during the past 7 days.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of distress from depression symptoms and negative values indicating decreased levels of distress from depression symptoms."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
2638168|NCT01775995|Other Pre-specified|Mental Health Symptom Severity|"Mental Health Symptom Severity was assessed using the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's Global Severity Index (i.e. total score, 0-360) reflects the degree of severity of mental health symptom distress during the past 7 days.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased levels of mental health symptom distress and negative values indicating decreased mental health symptom distress."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
2638169|NCT01775995|Other Pre-specified|Mental Health Symptom Severity|"Mental Health Symptom Severity was assessed using the 90-item Symptom Checklist - Revised (SCL-90-R). This measure's Global Severity Index (i.e. total score, 0-360) reflects the degree of severity of mental health symptom distress during the past 7 days.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased levels of mental health symptom distress and negative values indicating decreased mental health symptom distress."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
2638170|NCT01775995|Other Pre-specified|Perceived Stress|"Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). This measure's total score (0-40) reflects the degree to which one perceives their life experiences as stressful in the last month.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased perceived stress and negative values indicating decreased perceived stress."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
2638171|NCT01775995|Other Pre-specified|Perceived Stress|"Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10). This measure's total score (0-40) reflects the degree to which one perceives their life experiences as stressful in the last month.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased perceived stress and negative values indicating decreased perceived stress."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
2638882|NCT01769443|Secondary|Time From Wait Listing to Heart Transplantation||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
2638172|NCT01775995|Other Pre-specified|Chronic Pain Acceptance|"Pain acceptance was assessed using the 20-item Chronic Pain Acceptance Questionnaire (CPAQ). This measure's total score (0-120) reflects one's degree of acceptance of their chronic pain, not specifying a time frame.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased chronic pain acceptance and negative values indicating decreased chronic pain acceptance."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
2638173|NCT01775995|Other Pre-specified|Chronic Pain Acceptance|"Pain acceptance was assessed using the 20-item Chronic Pain Acceptance Questionnaire (CPAQ). This measure's total score (0-120) reflects one's degree of acceptance of their chronic pain, not specifying a time frame.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased chronic pain acceptance and negative values indicating decreased chronic pain acceptance."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
2638174|NCT01775995|Other Pre-specified|Drug Use|Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.|26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26 week follow-up. Results for this measure are based on the number of participants analyzed.|||percentage using drugs|||Number
2638175|NCT01775995|Other Pre-specified|Drug Use|Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.|8 weeks|One Meditation-CBT participant did not provide data for this measure at 8 week follow-up. Results for this measure are based on the number of participants analyzed.|||percentage using drugs|||Number
2638176|NCT01775995|Other Pre-specified|Drug Use|Percentage of participants endorsing drug use during the past 28 days was assessed using the Timeline Follow-Back Method.|Baseline||||percentage using drugs|||Number
2638177|NCT01775995|Other Pre-specified|Alcohol Use|Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.|26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26 week follow-up. Results for this measure are based on the number of participants analyzed.|||percentage using alcohol|||Number
2638178|NCT01775995|Other Pre-specified|Alcohol Use|Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.|8 weeks|One Meditation-CBT participant did not provide data for this measure at 8 week follow-up. Results for this measure are based on the number of participants analyzed.|||percentage using alcohol|||Number
2638179|NCT01775995|Other Pre-specified|Alcohol Use|Percentage of participants endorsing any alcohol use during the past 28 days was assessed using the Timeline Follow-Back Method.|Baseline||||percentage using alcohol|||Number
2638180|NCT01775995|Secondary|Opioid Dose|"Daily opioid dose was assessed using the Timeline Followback Method which looked at the past 28 days of opioid use. Medication use reports were verified against the medication bottles. Daily opioid dose was standardized [daily morphine-equivalent dose (MED)] across different opioids for each participant.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased daily opioid dose and negative values indicating decreased daily opioid dose."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.|||morphine-equivalent mg/day||95% Confidence Interval|Mean
2638181|NCT01775995|Secondary|Opioid Dose|"Daily opioid dose was assessed using the Timeline Followback Method which looked at the past 28 days of opioid use. Medication use reports were verified against the medication bottles. Daily opioid dose was standardized [daily morphine-equivalent dose (MED)] across different opioids for each participant.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased daily opioid dose and negative values indicating decreased daily opioid dose."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.|||morphine-equivalent mg/day||95% Confidence Interval|Mean
2638182|NCT01775995|Primary|Health-Related Quality of Life: Physical Function|"Physical function was assessed using the 10-item Oswestry Disability Index (ODI). This measure's total score (0-100) reflects the percent of chronic low back pain related disability today.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased disability and negative values indicating decreased disability."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.|||percentage disability||95% Confidence Interval|Mean
2638183|NCT01775995|Primary|Health-Related Quality of Life: Physical Function|"Physical function was assessed using the 10-item Oswestry Disability Index (ODI). This measure's total score (0-100) reflects the percent of chronic low back pain related disability today.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased disability and negative values indicating decreased disability."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.|||percentage disability||95% Confidence Interval|Mean
2638199|NCT01775852|Secondary|Mean Change on Short Form Health Survey (SF-36) From Baseline to 12 Week Follow-up.|"The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.~The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability."|Change at 12 week follow-up from baseline||||units on a scale||Standard Error|Mean
2638184|NCT01775995|Primary|Health-Related Quality of Life: Averaged Pain Severity|"Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now.~This outcome measure for 26 week follow up is expressed as a difference score (change from baseline to 26 week measure), with positive values indicating increased pain and negative values indicating decreased pain."|baseline to 26 weeks|One Meditation-CBT and one Wait-list Control participant did not provide data for this measure at 26-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
2638185|NCT01775995|Primary|Health-Related Quality of Life: Averaged Pain Severity|"Averaged pain is the average of 4 responses on a 0-10 numerical rating scale (0=no pain; 10=worst possible pain) from the Brief Pain Inventory (BPI): 1) describe your pain at its worst in the last week 2) describe your pain at its least in the last week 3) describe your pain on the average 4) describe your pain right now.~This outcome measure for 8 week follow up is expressed as a difference score (change from baseline to 8 week measure), with positive values indicating increased pain and negative values indicating decreased pain."|baseline to 8 weeks|One Meditation-CBT participant did not provide data for this measure at 8-week follow up. Results on this measure are based on the number of participants analyzed.|||units on a scale||95% Confidence Interval|Mean
2638186|NCT01775930|Secondary|PFS and ORR as a Function of VHL Mutation Subtype||No data collected|The futility stopping rule was meet due to the low response rate to the treatment. None of our patients had a better response than stable disease (SD). Consequently the correlative analyses were not performed for VHL mutation subtype only for PFS and ORR which is reported as Outcomes.||||||
2638187|NCT01775930|Secondary|Safety of Carfilzomib|Reason for stopping therapy|4 months||||Participants|||Count of Participants
2638188|NCT01775930|Secondary|Overall Survival (OS)|The number of months from the time of enrollment until death per participant|15 months||||Months||95% Confidence Interval|Median
2638189|NCT01775930|Secondary|Overall Response Rate (ORR)|The number of participants had a complete response (CR, complete reduction in tumor burden) or partial response (PR, a reduction in tumor burden of at least 30%) as determined for radiographic imaging such as a CT scan. Participants who do not have a reduction in tumor burden will either have stable disease (SD) or progressive disease (PD, which is an increase in tumor burden of at least 20%). The results are based on the best response that each participant achieved while on treatment.|Participants response was evaluated every 8 weeks from the first dose of carfilzomib until progression od disease (PD), up to 4 months||||Participants|||Count of Participants
2638190|NCT01775930|Primary|Progression Free Survival (PFS) of Carfilzomib Therapy in Participants With Refractory Or Intolerant to Prior Therapy|Progression free survival defined as time from enrollment to progression or death, whichever comes first. Progression defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Any patients who are alive and free of disease at time of analysis censored at date of most recent tumor assessment.|The number of months from enrollment to progression of cancer or death, whichever comes first up to 4 months||||Months||95% Confidence Interval|Median
2638191|NCT01775904|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞] of LY2886721||Baseline through 96 hours post-dose|Participants who received at least one dose of study drug with evaluable LY2886721 AUC (0-∞) data.|||nanograms * hour / milliliter||Geometric Coefficient of Variation|Geometric Mean
2638192|NCT01775904|Primary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Time Tlast (AUC[0-tlast]) of LY2886721||Baseline through 96 hours post-dose|Participants who received at least one dose of study drug with evaluable LY2886721 AUC (0-tlast) data.|||nanograms * hour / milliliter||Geometric Coefficient of Variation|Geometric Mean
2638193|NCT01775904|Primary|Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of LY2886721||Baseline through 96 hours post-dose|Participants who received at least one dose of study drug with evaluable LY2886721 tmax data.|||hours||Full Range|Median
2638194|NCT01775904|Primary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY2886721||Baseline through 96 hours post-dose|Participants who received at least one dose of study drug with evaluable LY2886721 Cmax data.|||nanograms / milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2638195|NCT01775865|Other Pre-specified|Tissue Doppler Left Ventricular Relaxation Velocity (E')|Left ventricular diastolic dysfunction|Change from baseline E' at 4 weeks|Data were not obtained because cardiac echos could not be performed in participants because of lack of equipment||||||
2638196|NCT01775865|Secondary|Brachial Artery Flow-mediated Dilation (FMD)|Endothelial function|Change from baseline brachial artery FMD at 4 weeks|After baseline measurements, there were 3 dropouts in salsalate group and 1 FMD that was not able to be anayzed (poor image quality) for a total of 10 in salsalate for FMD. There was 1 dropout in the placebo group and 2 FMDs not analyzed (poor image quality) for a total of 11 analyzed in placebo for FMD.|||Percent dilation||Standard Error|Mean
2638197|NCT01775865|Primary|Carotid-femoral Pulse Wave Velocity (CFPWV)|Aortic stiffness|Change in CFPWV from baseline at 4 weeks|After baseline measurements, there were 3 dropouts in salsalate group for a total of 11 completed in salsalate, and 1 dropout in the placebo group for a total of 13 completed in placebo.|||cm/sec||Standard Error|Mean
2638198|NCT01775852|Secondary|Mean Change of World Health Organization Disability Assessment (WHO-DAS) From Baseline to 12-week Follow up.|"The WHODAS contains 36 items on functioning and disability with a recall period of 30 days covering 7 domains: Understanding and Communicating (6 items), Getting around (5 items), Self-care (4 items), Getting along with others (5 items), Life activities: household (4 items), Life activities: work/school (4 items), and Participation in society (8 items). Response options go from 1 (no difficulty) to 5 (extreme difficulty or can not do).~WHODAS domain scores are computed for each domain by adding the item responses together. A global score is then computed by summing all domains together, and transforming them into a range from 0 to 100, with higher scores indicating higher levels of disability (0= no disability, 100= full disability)."|Change at 12 week follow-up from baseline||||units on a scale||Standard Error|Mean
2638216|NCT01775670|Secondary|Thumb Pinch Strength|Measurement of thumb pinch strength using a pinch meter. Subjects place the pinch meter between their thumb and index finger and pinch down to record the pinch strength.|At Enrollment||||pounds||Standard Deviation|Mean
2638200|NCT01775852|Secondary|Mean Change Score in HDI (Headache Disability Inventory) From Baseline to 12 Weeks.|"The HDI is useful in assessing the impact of headache, and its treatment, on daily living. 25 self-report items are rated with answers as Yes (4 points), Sometimes (2 Points), and No (0 points). All items are then added together to create an overall score which can range from 0 (no impact), to 100 (severe impact) of headache on daily life.~A 29 point change (95% confidence interval) or greater in the total score from test to retest must occur before the change can be attributed to treatment effects."|12 week change from baseline||||units on a scale||Standard Error|Mean
2638201|NCT01775852|Primary|Mean Change in Hamilton Depression Rating Scale (HAM-D) From Baseline to 12 Week Follow-up|"The HAM-D is a structured clinical interview for assessing depression severity. Outcome measure will be change from Baseline in Hamilton Depression Rating Scale at 12 week (3 month) follow-up from baseline.~Measure is scored by adding individual items and attaining an overall severity score. Scores range from 0 to 53, with higher values signifying a higher level of depression severity (and thus a worse outcome). A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial."|12 week change from baseline||||units on a scale||Standard Error|Mean
2638202|NCT01775800|Secondary|Symptom Burden|Number of symptoms in past week as measured by the Dialysis Symptom Index|Baseline and 6 weeks||||symptoms||Standard Deviation|Mean
2638203|NCT01775800|Primary|Number of Participants Recruited, Consented, Randomized and Completed||Each participant was assessed for 6 weeks; total recruitment period was 15 months|This number represents the entire dialysis population|||Participants|||Count of Participants
2638204|NCT01775787|Primary|Effects E-cig Use on Venous Nicotine Concentrations Before and 5 Minutes After Use|To determine the effects of acute E-cig use on venous nicotine concentrations 5 minutes before and 5 minutes after 7-10 days of e-cigarette use.|7-10 days|Nicotine Concentrations Before and 5 Minutes After Ecig Use were intended to be analyzed, regardless of flavor, as pre-specified in the study protocol,|||ng/ml||Standard Error|Mean
2638205|NCT01775774|Secondary|Mortality at Hospital Discharge|The number of patients expired at hospital discharge.|From study enrollment to Hospital discharge||||participants|||Number
2638206|NCT01775774|Secondary|Hospital Survival to Day 60|The number of subjects alive at study day 60. Those subjects discharged home prior to day 60 were counted as alive at day 60.|60 days after randomization||||participants|||Number
2638207|NCT01775774|Secondary|ICU Free Days to Day 28||28 days after study enrollment||||day||Full Range|Median
2638208|NCT01775774|Secondary|Duration of Vasopressor Use (Days)|Days on vasopressor to day 28 after study enrollment|28 days||||day||Full Range|Median
2638209|NCT01775774|Secondary|Ventilator Free Days at Study Day 28|Ventilator Free Days (VFDs) to day 28 were defined as the number of days from the time of initiating unassisted breathing to day 28 after randomization, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a subject received assisted breathing at day 27 or died prior to day 28, a value of zero VFDs was given.|time of initiating unassisted breathing to day 28||||day||Full Range|Median
2638210|NCT01775774|Secondary|Incidence of Severe Adverse Events (SAEs)|The number of participants with a severe adverse event during the study was assessed.|Investigators conducted daily assessments for the presence of adverse events (AE) from enrollment through study day 28 or hospital discharge, whichever occurred first.||||participants|||Number
2638211|NCT01775774|Primary|Incidence of Pre-specified Infusion Associated Adverse Events|"Any of the following occurring within 6 h of mesenchymal stem-cell infusion:~Addition of a third vasopressor or an increase in vasopressor dose greater than or equal to the following:~Norepinephrine: 10 μg per min~Phenylephrine: 100 μg per min~Dopamine: 10 μg/kg per min~Epinephrine: 0·1 μg/kg per min~Hypoxaemia requiring an increase in the fraction of inspired oxygen of ≥0·2 and increase in positive end-expiratory airway pressure level of 5 cm H2O or more to maintain transcutaneous oxygen saturations in the target range of 88-95%~New cardiac arrhythmia requiring cardioversion~New ventricular tachycardia, ventricular fi brillation, or asystole~A clinical scenario consistent with transfusion incompatibility or transfusion-related infection~Cardiac arrest or death within 24 h of mesenchymal stem-cell infusion"|24 hours||||participants|||Number
2638212|NCT01775735|Primary|Change in the Number of Moderate-to-severe Headache Days Per Month|"A moderate-to-severe headache day will be defined as any calendar day with:~headache pain that lasts ≥4 hours AND peak severity of moderate or severe intensity~OR~a subject taking a triptan or ergot, regardless of headache pain duration or severity~The Baseline number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the first 30 calendar days of eDiary entries if the eDiary contained ≥70% of data. The 6 months post-randomization number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the 30 calendar days of eDiary entries immediately preceding the subject's 6-Month Visit if the eDiary contained ≥70% of data."|from Baseline to 6 months post-randomization|All subjects who completed Baseline and 6 months post-randomization and had ≥70% of eDiary data. Data for 5 subjects was not calculated due to missing eDiary data. Statistical analysis was not performed as the sample size is too small to draw any statistically relevant conclusions.|||days||Standard Deviation|Median
2638213|NCT01775722|Primary|Percent Change in Blanching of Port Wine Stain|Port Wine Stain blood volume fractions in the skin before (fB1), and 8 weeks after (fB2) treatment will be determined using the corresponding visual reflectance spectra measured at the treatment sites. The primary outcome, degree of blanching, B, is computed as B = (fB1-fB2)/fB1.|8 weeks|Each subject received both treatments on their corresponding test sites. We compared response of test sites to different treatment.|||percentage|Test site|Standard Deviation|Mean
2638214|NCT01775670|Primary|Average Pain 2 Months After Enrollment|Average pain will be assessed 2 months after enrollment. 11-point ordinal pain scale to assess the amount of pain. The scale range for pain is from 0-10, where 0 is no pain and 10 is the worst pain.|At 2 months after enrollment|Subjects did not complete the pain scale questionnaire at the follow up visit.||||||
2638215|NCT01775670|Secondary|Thumb Grip Strength|Grip strength of the affected hand was measured at enrollment using a dynamometer. The subject squeezes the handle of the dynamometer to maximum capability to measure grip strength. Each subject completed the grip strength measurement 3 times on the affected hand to get an average grip strength of the affected hand.|At Enrollment||||pounds||Standard Deviation|Mean
2638220|NCT01775670|Secondary|Patient Reported Outcomes Measurement Information System (PROMIS) - Depression|A computerized assessment of depression measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is worse than the average and a T score less than 50 is better than the average.|At Enrollment|The data was not recorded for the 1 patient randomized to the off-the-shelf group.|||T score||Standard Deviation|Mean
2638221|NCT01775670|Primary|Average Satisfaction With the Splint 2 Months After Enrollment|Average satisfaction with splint treatment will be assessed 2 months after enrollment. 11-point ordinal pain scale to assess the amount of satisfaction. The scale range for satisfaction is from 0-10, where 0 is dissatisfaction and 10 is complete satisfaction with the splint.|At 2 months after enrollment||||units on a scale||Standard Deviation|Mean
2638222|NCT01775670|Primary|Thumb Pain at Enrollment|11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had.|At enrollment||||units on a scale||Standard Deviation|Mean
2638223|NCT01775670|Primary|Change From the Baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 2 Months After Enrollment|The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks. This was measured 2-month after treatment.|2 months after enrollment|The one subject in the off-the-shelf group was lost to follow up.|||units on a scale||Standard Deviation|Mean
2638224|NCT01775670|Primary|Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH)|The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.|At enrollment||||units on a scale||Standard Deviation|Mean
2638225|NCT01775553|Secondary|Markers of ER Stress|The markers of ER stress signaling (both apoptotic and prosurvival) in MM cells from patients in this study and to determine if the balance of apoptotic versus prosurvival signaling changes upon recapture of response with carfilzomib dose escalation relative to the time of study entry.|up to 4 years|data not collected||||||
2638226|NCT01775553|Secondary|Duration of Response to High Dose Carfilzomib||up to 4 years||||months||Full Range|Median
2638227|NCT01775553|Secondary|Overall Response Rate (ORR)|Overall Response Rate defined in categories|up to 4 years||||Participants|||Count of Participants
2638228|NCT01775553|Secondary|Progression Free Survival (PFS)||up to 4 years||||months||Full Range|Median
2638229|NCT01775553|Primary|Safety and Efficacy of High Dose Carfilzomib|The safety and efficacy of high dose carfilzomib who developed disease progression on the standard dosing and schedule of carfilzomib as measured by number of participants with adverse events|up to 4 years||||Participants|||Count of Participants
2638230|NCT01775501|Secondary|Duration of Response|The median amount of time from achieving a response (partial or complete) until disease progression, death, or loss to follow-up.|From the time of treatment response until death or disease progression (median duration 172 days)||||Days||95% Confidence Interval|Median
2638231|NCT01775501|Secondary|Median Overall Survival|The duration of time from study registration until death.|From registration until death, median duration of 15.1 months||||Months||95% Confidence Interval|Median
2638232|NCT01775501|Secondary|Median Progression Free Survival|The median duration of time from the start of treatment until disease progression or death|From the start of treatment until disease progression or death, median duration of 232 days||||Days||95% Confidence Interval|Median
2638233|NCT01775501|Secondary|Overall Response Rate|"Overall response rate is the number of participants that achieved either a complete or partial response according to RECIST 1.1 criteria.~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."|2 years||||Participants|||Count of Participants
2638234|NCT01775501|Secondary|Number of Patients Experiencing Adverse Events|To evaluate the tolerability and toxicities of FOLFOX-S regimen in this population of patients.|From the start of treatment until 30 days after the end of treatment, median duration of 10.7 months||||Participants|||Count of Participants
2638235|NCT01775501|Primary|Time to Progression|"The median amount of time from the time of registration until disease progression. Disease progression was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.~Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)."|The amount of time from registration until disease progression or death, median duration 7.7 months||||Months||95% Confidence Interval|Median
2638236|NCT01775189|Other Pre-specified|Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2)|Oxygen saturation of hemoglobin in blood (SpO2) was monitored using pulse oximetry continuously for 5 hours following dosing in the drug discrimination phase and continuously for 12 hours following dosing in the treatment phase, or longer at the discretion of the investigator. Individual measurement was collected in a sitting position. If SpO2 fall below 90 percent (%), the investigator administered oxygen via nasal cannula at a flow rate sufficient to maintain the SpO2 greater than or equal to 90%. Participants with fall in SpO2 below 90% were reported.|Drug discrimination phase: pre-dose up to 5 hours; intervention period: pre-dose up to 12 hours|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.|||participants|||Number
2638237|NCT01775189|Other Pre-specified|Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2)|End-tidal carbon dioxide concentration in the expired air (EtCO2) was monitored using capnography in a sitting position. Criteria for clinically significant change in EtCO2 was based on investigator's discretion.|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.|||participants|||Number
2638238|NCT01775189|Other Pre-specified|Number of Participants With Clinically Significant Change in Vital Sign Examinations|Vital signs assessment included measurement of heart rate, systolic and diastolic blood pressures, and respiratory rate. Criteria for clinically significant change in any vital sign examination was based on investigator's discretion.|Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.|||participants|||Number
2638239|NCT01775189|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 3 - 7 days following last study drug administration that were absent before treatment or that worsened relative to pre-treatment state. Symptoms of withdrawal following naloxone administration (naloxone challenge phase) were not collected as adverse events unless they met the criteria for an SAE. AEs included SAEs as well as non-serious AEs which occurred during the trial.|Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.|||participants|||Number
2638240|NCT01775189|Other Pre-specified|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone and 6-beta-naltrexol|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here ‘n’ signifies those participants who were evaluable for specified category.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
2638241|NCT01775189|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Naltrexone and 6-beta-naltrexol|Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast). Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
2638242|NCT01775189|Other Pre-specified|Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Naltrexone and 6-beta-naltrexol|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
2638243|NCT01775189|Other Pre-specified|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Oxycodone, Oxymorphone and Noroxycodone|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here ‘n’ signifies participants evaluable for specified category for each arm, respectively.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
2638244|NCT01775189|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone, Oxymorphone and Noroxycodone|Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast). Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
2638245|NCT01775189|Other Pre-specified|Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
2638246|NCT01775189|Other Pre-specified|Plasma Decay Half-Life (t1/2) of Naltrexone and 6-beta-naltrexol|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here ‘n’ signifies those participants who were evaluable for specified category.|||hours||Standard Deviation|Mean
2638268|NCT01775189|Secondary|Sleepy: Peak Effect (Emax)|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
2638247|NCT01775189|Other Pre-specified|Plasma Decay Half-Life (t1/2) of Oxycodone, Oxymorphone and Noroxycodone|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here ‘n’ signifies participants evaluable for specified category for each arm, respectively.|||hours||Standard Deviation|Mean
2638248|NCT01775189|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol|Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.|||hours||Full Range|Median
2638249|NCT01775189|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone|Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here ‘n’ signifies participants evaluable for specified category for each arm, respectively.|||hours||Full Range|Median
2638250|NCT01775189|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol|Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2638251|NCT01775189|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Oxycodone, Oxymorphone and Noroxycodone|Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the pharmacokinetic (PK) parameters of interest.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2638252|NCT01775189|Other Pre-specified|Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax)|"Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem as bad as can be). TEmax = Time to maximum observed score."|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.|||hours||Full Range|Median
2638253|NCT01775189|Other Pre-specified|Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour|"Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem as bad as can be). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x)."|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.|||units on a scale*hours||Standard Deviation|Mean
2638254|NCT01775189|Other Pre-specified|Subject Rating Scale for Nasal Effects: Peak Effect (Emax)|"Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem as bad as can be). Emax = Maximum observed score."|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.|||units on a scale||Standard Deviation|Mean
2638255|NCT01775189|Other Pre-specified|High: Time to Maximum (Peak) Effect (TEmax)|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours||Full Range|Median
2638256|NCT01775189|Other Pre-specified|High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x).|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
2638257|NCT01775189|Other Pre-specified|Drug Liking: Time to Maximum (Peak) Effect (TEmax)|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). TEmax = Time to maximum observed score."|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours||Full Range|Median
2639592|NCT01763905|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2638258|NCT01775189|Other Pre-specified|Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x)."|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
2638259|NCT01775189|Secondary|Pupillometry: Time to Maximum (Peak) Effect (TEmax)|Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||hours||Full Range|Median
2638260|NCT01775189|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||hours*mm||Standard Deviation|Mean
2638261|NCT01775189|Secondary|Pupillometry: Peak Effect (Emax)|Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. Emax = Maximum observed score.|Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose PD data from each period. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||mm||Standard Deviation|Mean
2638262|NCT01775189|Secondary|Percentage of Dose (Drug Powder) Insufflated|The percentage of dose insufflated, was based on a calculation of the weight of powder remaining (if any) following each dosing during the intervention period.|Intervention period: 0 Hour post-dose|Safety analysis set included all participants who received at least 1 dose of study drug, beginning with the naloxone challenge phase.|||percentage of dose||Standard Deviation|Mean
2638263|NCT01775189|Secondary|Dizzy: Time to Maximum (Peak) Effect (TEmax)|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours||Full Range|Median
2638264|NCT01775189|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
2638265|NCT01775189|Secondary|Dizzy: Peak Effect (Emax)|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
2638266|NCT01775189|Secondary|Sleepy: Time to Maximum (Peak) Effect (TEmax)|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours||Full Range|Median
2638267|NCT01775189|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
2639593|NCT01763905|Secondary|Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2638269|NCT01775189|Secondary|Nausea: Time to Maximum (Peak) Effect (TEmax)|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours||Full Range|Median
2638270|NCT01775189|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
2638271|NCT01775189|Secondary|Nausea: Peak Effect (Emax)|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
2638272|NCT01775189|Secondary|Feel Sick: Time to Maximum (Peak) Effect (TEmax)|Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours||Full Range|Median
2638273|NCT01775189|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
2638274|NCT01775189|Secondary|Feel Sick: Peak Effect (Emax)|Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention periods: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
2638275|NCT01775189|Secondary|Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)|Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours||Full Range|Median
2638276|NCT01775189|Secondary|Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
2638277|NCT01775189|Secondary|Bad Drug Effects: Peak Effect (Emax)|Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
2638278|NCT01775189|Secondary|Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)|Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours||Full Range|Median
2638279|NCT01775189|Secondary|Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
2638421|NCT01774149|Other Pre-specified|Usability|System Usability Scale (SUS) will be applied to assess usability of the approach and recorded during the last week of intervention (week 12 for the intervention group and week 20 for the active comparator group).|up to 20 weeks post-enrollment|||||||
2638280|NCT01775189|Secondary|Good Drug Effects: Peak Effect (Emax)|Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
2638281|NCT01775189|Secondary|Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)|Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours||Full Range|Median
2638282|NCT01775189|Secondary|Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour|Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
2638283|NCT01775189|Secondary|Any Drug Effects: Peak Effect (Emax)|Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
2638284|NCT01775189|Secondary|Overall Drug Liking Effect at Hours 12 and 24|"Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking)."|Intervention period: 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
2638285|NCT01775189|Secondary|Overall Drug Liking: Mean Effect (Emean)|"Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking). Emean = Average observed score."|Intervention period: 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
2638286|NCT01775189|Secondary|Overall Drug Liking: Peak Effect (Emax)|"Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking). Emax = Maximum observed score."|Intervention period: 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
2638287|NCT01775189|Secondary|Take Drug Again Effect at Hours 12 and 24|"Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would)."|Intervention period: 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
2638288|NCT01775189|Secondary|Take Drug Again: Mean Effect (Emean)|"Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would). Emean = Average observed score."|Intervention period: 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
2638289|NCT01775189|Secondary|Take Drug Again: Peak Effect (Emax)|"Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would). Emax = Maximum observed score."|Intervention period: 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
2638290|NCT01775189|Primary|High: Area Under Effect Curve (AUE) From 0-2 Hour|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
2638963|NCT01769209|Secondary|Overall Survival (OS)|Overall survival (OS) was assessed as participants remaining alive 2 years after induction therapy. The outcome is reported as the number of participants (without dispersion).|2 years||||Participants|||Count of Participants
2638291|NCT01775189|Primary|High: Peak Effect (Emax)|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
2638292|NCT01775189|Primary|Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the extreme left with strong disliking (score of 0 mm) and on the extreme right with strong liking (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours."|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||hours*mm||Standard Deviation|Mean
2638293|NCT01775189|Primary|Drug Liking: Peak Effect (Emax)|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the extreme left with strong disliking (score of 0 mm) and on the extreme right with strong liking (score of 100 mm). Peak Effect (Emax) = Maximum observed score."|Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose|Completer analysis set included all randomized participants who completed all 4 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
2638294|NCT01775137|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 6 Treatment Cycles in Extension Study|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalisation, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Death was a fatal event leading to permanent cessations of all vital functions of the body.|Baseline (start of study treatment in extension study) to Day 673 (end of the extension study)|The analysis was performed in extension safety population, defined as all the participants who entered the extension study and received at least one dose of study drug within the extension.|||Number of participants|||Number
2638295|NCT01775137|Secondary|Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study|The day of first hospitalization due to serious respiratory related adverse events was analysed using Kaplan Meier estimate.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.|||Days||95% Confidence Interval|Median
2638296|NCT01775137|Secondary|Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study|The total number of hospitalisation days due to serious respiratory-related adverse events was analysed using Kaplan-Meier estimate.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.|||Days||Full Range|Median
2638297|NCT01775137|Secondary|Percentage of Participants Hospitalized Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study|The percentage of the participants hospitalized due to serious respiratory-related AEs were determined during the extension study.|Baseline of extension study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.|||Percentage of participants|||Number
2638298|NCT01775137|Secondary|Time to Use of New Anti-pseudomonal Antibiotics in Extension Study|Time to first usage of anti-pseudomonal antibiotic was determined using Kaplan Meier estimate. Participants without an event were censored at the date of the last available post-baseline measurement.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.|||Days||95% Confidence Interval|Median
2638299|NCT01775137|Secondary|Total Number of Days of New Anti-pseudomonal Antibiotics Use in Extension Study|The total number of days with usage of new anti-pseudomonal antibiotic were determined.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively|||Days||Full Range|Median
2638300|NCT01775137|Secondary|Percentage of Participants Who Used New Anti-pseudomonal Antibiotics in Extension Study|The rate of anti-pseudomonal antibiotics use were determined from the collection of concomitant medication during the study.|Baseline of extension study, Day 673 (end of extension study)|The analysis was performed in extension safety population.|||Percentage of participants|||Number
2638301|NCT01775137|Secondary|Absolute Change From Baseline in Pseudomonas Aeruginosa Density Over 6 Treatment Cycles in Extension Study|Microbiological data was collected to understand the direct impact of the drug on the pathogens. Sputum samples were cultured for the presence of three Pseudomonas aeruginosa (P. aeruginosa) biotypes measured were mucoid, dry and small colony variant. If no P. aeruginosa was isolated for a visit, log10 colony forming units (CFU) was imputed with log10 (19) for all biotypes. Absolute change was calculated by using the formula = (Value at actual time point - start of extension value).|Baseline (start of study treatment in extension study), Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|The analysis was performed in extension safety population, who had microbiological data at specified time points. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||log10 CFU||Standard Deviation|Mean
2638343|NCT01774968|Secondary|Percentage of Participants Achieving HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24|The percentage of participants achieving an HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24 was calculated by the dividing the number of participants meeting the criteria by the total number of participants analyzed, multiplied by 100.|Week 24|Randomized participants who received at least 1 dose of U-500R, who were not at the HbA1c target at baseline, and had evaluable HbA1c data.|||percentage of participants|||Number
2638302|NCT01775137|Secondary|Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 6 Treatment Cycles in Extension Study|FEV1 was defined as the volume of air expired in 1 second. FEV1 was assessed as a pulmonary function by using spirometry tests in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria. FEV1% predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day*FEV1% predicted - baseline FEV1% predicted) / baseline FEV1 % predicted) x 100.|Baseline (start of study treatment in extension study), Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|Extension safety population, defined as all the participants who entered the extension study and received at least one dose of study drug within the extension and had FEV1% values at both baseline and the post baseline time points. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percent change in FEV1 % predicted||Standard Deviation|Mean
2638303|NCT01775137|Secondary|Acute Relative Change From Pre-dose to 30-minute Post-dose in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles|FEV1 was defined as the volume of air expired in 1 second. FEV1 was assessed as a pulmonary function by using spirometry tests in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria. Relative change in FEV1 % predicted was calculated by using the formula = 100 *(30-min post-dose value - pre-dose value) / pre-dose value.|Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|The analysis was performed in extension safety population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percent change in FEV1 % predicted||Standard Deviation|Mean
2638304|NCT01775137|Secondary|Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles|The day of first hospitalization due to serious respiratory-related adverse events was analysed using Kaplan Meier estimate.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.|||Days||95% Confidence Interval|Median
2638305|NCT01775137|Secondary|Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles|The total number of hospitalization days due to serious respiratory-related adverse events was analyzed using Kaplan-Meier estimate.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.|||Days||Full Range|Median
2638306|NCT01775137|Secondary|The Percentage of the Participants Hospitalized Due to Serious Respiratory-related AEs Were Determined During the Study.|The percentage of the participants hospitalized due to serious respiratory-related AEs were determined during the study.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.|||Percentage of participants|||Number
2638307|NCT01775137|Secondary|Time to Use of New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles|Time to first usage of anti-pseudomonal antibiotic was determined using Kaplan Meier estimate. Participants without an event were censored at the date of the last available post-baseline measurement.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.|||Days||95% Confidence Interval|Median
2638308|NCT01775137|Secondary|Total Number of Days of New Anti-pseudomonal Antibiotics Use Over 12 Treatment Cycles|The total number of days with usage of new anti-pseudomonal antibiotic were determined.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Days||Full Range|Median
2638309|NCT01775137|Secondary|Percentage of Participants Who Used New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles|The rate of anti-pseudomonal antibiotics use were determined from the collection of concomitant medication during the study.|Baseline of core study, Day 673 (end of the extension study)|The analysis was performed in extension safety population.|||Percentage of participants|||Number
2638310|NCT01775137|Secondary|Tobramycin Minimum Inhibitory Concentration (MIC) 50 and MIC 90 Values for Pseudomonas Aeruginosa Over 12 Treatment Cycles|MIC was defined as the lowest concentration of an antimicrobial agent required to inhibit the visible growth of a microorganism after overnight incubation. Tobramycin MIC 50 and MIC 90 values were defined as the lowest concentration of tobramycin required to inhibit 50% and 90%, respectively, of the P. aeruginosa strains tested (mucoid,dry and small colony variant biotypes).|Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|The analysis was performed in extension safety population, who had microbiological data at specified time points. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||micrograms/milliliters|||Number
2638311|NCT01775137|Secondary|Absolute Change From Baseline in Pseudomonas Aeruginosa Sputum Density Over 12 Treatment Cycles|Microbiological data was collected to understand the direct impact of the drug on the pathogens. Sputum samples were cultured for the presence of three Pseudomonas aeruginosa (P. aeruginosa) biotypes measured were mucoid, dry and small colony variant. Absolute change was determined using the formula = (Post-baseline value- baseline value). If no P. aeruginosa was isolated for a visit, log10 colony forming units (CFU) was imputed with log10 (19) for all biotypes.|Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day||||log 10 CFU/g||Standard Deviation|Mean
2638321|NCT01775124|Secondary|Number of Patients With a BCVA Improvement of ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 24|Visual acuity (VA) was at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient improved by equal or more than 5, 10, 15,or 30 letters of VA as compared to baseline.|Baseline to Month 24|Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Patients|||Number
2638312|NCT01775137|Secondary|Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles|FEV1 was defined as the volume of air expired in 1 second. FEV1 was assessed as a pulmonary function by using spirometry tests in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria. FEV1% predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day*FEV1% predicted - baseline FEV1% predicted) / baseline FEV1 % predicted) x 100.|Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)|Extension safety population, defined as all the participants who entered the extension study and received at least one dose of study drug within the extension and had FEV1% values at both baseline and the post baseline time points. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percent change in FEV1 % predicted||Standard Deviation|Mean
2638313|NCT01775137|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 12 Treatment Cycles|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Based on the severity, AEs were categorised into 3 types as mild, moderate and severe. Death was a fatal event leading to permanent cessations of all vital functions of the body.|Baseline (start of study treatment in core study) to Day 673 (end of the extension study)|The analysis was performed in extension safety population, defined as all the participants who entered the extension study and received at least one dose of study drug within the extension.|||Participants|||Number
2638314|NCT01775124|Secondary|Duration of Active Treatment Phase up to Month 24||up to month 24|Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment|||Months||Standard Deviation|Mean
2638315|NCT01775124|Secondary|Duration of Active Treatment Phase Prior to Month 12||Prior to month 12|Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment|||Months||Standard Deviation|Mean
2638316|NCT01775124|Secondary|Duration of Ranibizumab Treatment Free Interval in the Study Eye Prior to Month 12|This outcome measure describes duration of treatment-free intervals prior to month 12. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption Treatment-free interval is analyzed in the Ranibizumab 0.5 mg PRN group only. It is not analyzed in the Ranibizumab 0.5 mg monthly group because, by protocol design, these participants receive treatment monthly. Therefore, the analysis does not apply to this group.|prior to month 12|Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment|||Months||Standard Deviation|Mean
2638317|NCT01775124|Secondary|Duration of Ranibizumab Treatment Free Interval in the Study Eye up to Month 24|This outcome measure describes duration of treatment-free intervals. Treatment-free interval is defined as the number of visits (whether attended or not) where ranibizumab was not administered. n= the number of patients who had at least one ranibizumab treatment interruption|up to month 24|Safety set consisted of all patients who received at least one application of ranibizumab ( active study treatment) and had at least one post-baseline safety assessment. A patient who had no AEs also constituted a safety assessment|||Months||Standard Deviation|Mean
2638318|NCT01775124|Secondary|Change From Baseline in Central Sub-Field Thickness (CSFT) of the Study Eye Over Time to Month 12 and Month 24|Optical coherence tomography(OCT) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center. The Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit|Baseline to Month 24|Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (LOCF)= last observation carried forward|||microns||Standard Deviation|Mean
2638319|NCT01775124|Secondary|Number of Patients With a Best Corrected Visual Acuity (BCVA) of More of 73 Letters or More|Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for Month 12 and Month 24 whether a patient had a VA score of 73 or more letters|Month 12 and 24|Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Patients|||Number
2638320|NCT01775124|Secondary|Number of Patients With a BCVA Loss of 15 Letters in the Study Eye Over Time|Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.|Baseline to Month 24|Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Patients|||Number
2638977|NCT01769196|Secondary|Overall Survival (OS)|Overall survival was defined as the time from randomization date to death that occurred prior to the last dose date plus 30 days.|Up to 151 weeks|ITT Analysis Set|||months||95% Confidence Interval|Median
2638322|NCT01775124|Secondary|Change From Baseline in Visual Acuity (Letters) of the Study Eye Over Time|Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline|Baseline to 24 months|Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||letters||Standard Deviation|Mean
2638323|NCT01775124|Secondary|Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and Month 1 Through Month 24|Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the difference between VA averaged across all visits from Month 1 through Month 12 (24) and the baseline VA level|Baseline to Month 24|Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Letters||Standard Deviation|Mean
2638324|NCT01775124|Secondary|Average Visual Acuity Change (Letters) From Month 3 to Month 4 Through Month 24|Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the average level of VA over all monthly post-baseline assessments from Month 4 to Month 24 and the Month 3 Level of VA. The treatment regimen up to Month 3 is the same in both treatment groups.|Month 3 to month 4 through Month 24|Full Analysis Set: Consisted of all patients to whom study treatment were assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Letters||Standard Deviation|Mean
2638325|NCT01775124|Primary|Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12|Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the VA averaged across all visits from Month 4 through 12 and the Month 3 Level of Visual Acuity (Letters) of the Study Eye. The treatment regimen up to Month 3 is the same in both treatment groups.|Month 3 to month 4 through Month 12|Full Analysis Set: Consisted of all patients to whom study treatment was assigned. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at randomization. (MV-LOCF)=Mean value interpolation and last observation carried forward|||Letters||Standard Deviation|Mean
2638326|NCT01774981|Secondary|Part B: Change From Baseline in Albuminuria Over Time|Albuminuria is defined as the ratio of albumin to creatinine.|Baseline, 19 Weeks|All randomized participants who received at least one dose of study drug and were in Part B with a baseline measurement and at least one post-baseline measurement.|||mg/dl of albumin/ by mg/dl of creatinine||Standard Deviation|Mean
2638327|NCT01774981|Secondary|Part B: Change From Baseline in Proteinuria Over Time|Proteinuria is defined as the ratio of protein to creatinine.|Baseline, 19 Weeks|All randomized participants who received at least one dose of study drug and were in Part B with a baseline measurement and at least one post-baseline measurement.|||mg/dl of protein/ by mg/dl of creatinine||Standard Deviation|Mean
2638328|NCT01774981|Primary|Part A and Part B: Number of Participants With One or More Treatment Emergent Adverse Events (AEs) or Any Serious AEs|Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.|Baseline up to 32 Weeks|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2638329|NCT01774981|Primary|Part B:Change From Baseline in Proteinuria|Proteinuria is defined as the ratio of protein to creatinine.|Baseline, 16 Weeks|All randomized participants who received at least one dose of study drug in Part B with a baseline measurement and at least one post-baseline measurement.|||grams per 12 hour (g/12 hour)||Standard Deviation|Mean
2638330|NCT01774968|Secondary|Change From Baseline to Week 24 in Body Weight Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg|Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or >2.0 units/kg). LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline body weight as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable body weight data.|||kg||Standard Error|Least Squares Mean
2638331|NCT01774968|Secondary|Change From Baseline to Week 24 in Percentage of Participants With Hypoglycemic Events Based on Baseline TDD Insulin ≥2.0 Units/kg and <2.0 Units/kg|Participants were stratified by their baseline TDD insulin (≤2.0 units (U)/kg or >2.0 U/kg). The percentage of participants at risk of developing hypoglycemia (including documented symptomatic, asymptomatic, probable symptomatic, unspecified, or severe hypoglycemia) is presented at Baseline and at Week 24 and was calculated using MMRM fit with options of the binomial distribution and log link function including treatment, TDD (>300 units or ≤300 units), pioglitazone use (yes or no), visit, and treatment-by-visit interaction as fixed effects, and baseline HbA1c value as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R.|||percentage of participants|||Number
2638397|NCT01774604|Secondary|Number of Patients Who Developed Gastrointestinal Bleeding|Number of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure|From randomization to 30 days after ERCP||||participants|||Number
2638332|NCT01774968|Secondary|Change From Baseline to Week 24 in 30-Day Adjusted Rate of Hypoglycemic Events Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg|Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or >2.0 units/kg). Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person [accompanied by neurologic/cognitive impairment]), documented symptomatic (DS; an event which is associated with signs/symptoms of hypoglycemia and plasma glucose [PG] ≤70 milligrams per deciliter [mg/dL]), or nocturnal (Noc; any documented symptomatic HE that occurred between bedtime and waking). The 30-day adjusted rate of HE is summarized cumulatively at 24 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R.|||events per participant per 30 days||Standard Deviation|Mean
2638333|NCT01774968|Secondary|Change From Baseline to Week 24 in HbA1c Based on Baseline TDD Insulin ≤2.0 Units/kg and >2.0 Units/kg|Participants were stratified by their baseline TDD insulin (≤2.0 units/kg or >2.0 units/kg). LS means of change from baseline were calculated using MMRM with investigator, baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable HbA1c data.|||percentage of HbA1c||Standard Error|Least Squares Mean
2638334|NCT01774968|Secondary|Mean Change From Baseline to Week 24 in 7-Point Self-Monitored Blood Glucose (SMBG)|The 7-point SMBG is a participant self-administered blood glucose test which utilizes measurements at specific time points over a 24-hour period, including pre-morning meal (fasting), 2 hours after morning meal, pre-midday meal, 2 hours after midday meal, pre-evening meal, 2 hours after evening meal, and 3 AM. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline SMBG as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable SMBG data.|||mg/dL||Standard Error|Least Squares Mean
2638335|NCT01774968|Secondary|Change From Baseline to Week 24 in Number of Insulin Injections|The number of insulin injections per day at baseline (Week 0) and at Week 24 are presented.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R. Last observation carried forward (LOCF) was used to impute missing postbaseline values.|||injections per day||Standard Deviation|Mean
2638336|NCT01774968|Secondary|Percentage of Participants With Hypoglycemic Events|Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person [accompanied by neurologic/cognitive impairment]), documented symptomatic (an event which is associated with signs/symptoms of hypoglycemia and plasma glucose [PG] ≤70 milligrams per deciliter [mg/dL]), documented symptomatic nocturnal (any documented symptomatic HE that occurred between bedtime and waking), or asymptomatic (any measured PG ≤70 mg/dL not accompanied by hypoglycemic signs/symptoms). The percentage of participants with HE at 24 weeks was calculated by the dividing the number of participants meeting the criteria by the total number of participants analyzed, multiplied by 100. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Week 24|Randomized participants who received at least 1 dose of U-500R.|||percentage of participants|||Number
2638337|NCT01774968|Secondary|Time to Reach HbA1c Target Values|The cumulative number of participants achieving an HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% is summarized at Weeks 6, 12, 18, and 24. The number of participants at risk (n) is also provided for each target value and timepoint.|Baseline through 6, 12, 18, and 24 weeks.|Randomized participants who received at least 1 dose of U-500R, who were not at the HbA1c target at baseline, and had evaluable HbA1c data|||participants|||Number
2638338|NCT01774968|Secondary|Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) Levels|LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline FPG as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable FPG data.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2638339|NCT01774968|Secondary|Change From Baseline to Week 24 in Total Daily Dose (TDD; Units/kg) of Insulin|Baseline TDD was defined as the last U-100 insulin TDD prior to receiving the first dose of U-500R insulin. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline TDD as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable TDD data.|||units per kilogram (units/kg)||Standard Error|Least Squares Mean
2638340|NCT01774968|Secondary|Change From Baseline to Week 24 in Total Daily Dose (TDD; Units) of Insulin|Baseline TDD was defined as the last U-100 insulin TDD prior to receiving the first dose of U-500R insulin. LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline TDD as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable TDD data.|||units||Standard Error|Least Squares Mean
2638341|NCT01774968|Secondary|Change From Baseline to Week 24 in Body Weight|LS means of change from baseline were calculated using MMRM with investigator, baseline HbA1c (≤8% or >8%), baseline TDD (≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline body weight as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable body weight data.|||kilograms (kg)||Standard Error|Least Squares Mean
2638342|NCT01774968|Secondary|30-Day Adjusted Rate of Hypoglycemic Events|Hypoglycemic events (HE) were classified as severe (an event requiring assistance from another person [accompanied by neurologic/cognitive impairment]), documented symptomatic (an event which is associated with signs/symptoms of hypoglycemia and plasma glucose [PG] ≤70 milligrams per deciliter [mg/dL]), documented symptomatic nocturnal (any documented symptomatic HE that occurred between bedtime and waking), or asymptomatic (any measured PG ≤70 mg/dL not accompanied by hypoglycemic signs/symptoms). The 30-day adjusted rate of HE is summarized cumulatively at 24 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Week 24|Randomized participants who received at least 1 dose of U-500R.|||events per participant per 30 days||Standard Deviation|Mean
2638344|NCT01774968|Primary|Change From Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c)|Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with investigator, baseline total daily dose (TDD; ≤300 or >300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate.|Baseline, Week 24|Randomized participants who received at least 1 dose of U-500R with evaluable HbA1c data.|||percentage of HbA1c||Standard Error|Least Squares Mean
2638345|NCT01774929|Secondary|Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 15 and Day 30|The WOMAC is a self-administered; participant reported health status questionnaire designed to capture elements of pain, stiffness and physical impairment in participants with osteoarthritis. It consists of 24 questions (5 questions about pain, 2 about stiffness and 17 about physical function) scored on a VAS of 0 to 10 cm (0 cm=no pain to 10 cm=worse pain). Individual question responses are assigned a score of between 0=extreme and 4=none. Maximum scores for each element differ and therefore, scores were normalized. Total normalized score ranges from 0=worst to 100=best.|Baseline, Day 15 and Day 30|"ITT population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. N” signifies those participants who were evaluated for this outcome measure."|||Units on a scale||Standard Deviation|Mean
2638346|NCT01774929|Primary|Pain Intensity Score at Day 30|The pain intensity was assessed by using a 10 cm VAS ranging from 0 cm=no pain to 10 cm=worse pain.|Day 30|ITT population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. “N” signifies those participants who were evaluated for this outcome measure.|||cm||Standard Deviation|Mean
2638347|NCT01774929|Primary|Pain Intensity Score at Day 15|The pain intensity was assessed by using a 10 centimeter (cm) Visual Analog Scale (VAS) ranging from 0 cm=no pain to 10 cm=worse pain.|Day 15|Intent to treat (ITT) population included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy assessment. “N” signifies those participants who were evaluated for this outcome measure.|||cm||Standard Deviation|Mean
2638348|NCT01774903|Secondary|Number of Participants With Participant Global Assessment|Participants completed a global assessment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent worse, 0=unchanged and 4=100 percent improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=Mild, 3=Moderate, 4=Severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent).|Day 30|PP population included all participants who completed the 30-day study.|||participants|||Number
2638349|NCT01774903|Secondary|Number of Participants With Investigator Global Assessment|Investigator completed a global assessment of the participants treatment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent worse, 0=unchanged and 4=100 percent improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=mild, 3=moderate, 4=severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent).|Day 30|Per protocol (PP) population included all participants who completed the 30-day study.|||participants|||Number
2638350|NCT01774903|Primary|Pain Intensity at Day 30|Pain control was assessed by using a 10 cm VAS ranging from 0 to 10, where 0 cm=no pain and 10 cm=worse pain.|Day 30|ITT population included all participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.|||cm||Standard Deviation|Mean
2638351|NCT01774903|Primary|Pain Intensity at Day 15|Pain control was assessed by using a 10 centimeter (cm) visual analog scale (VAS) ranging from 0 to 10, where 0 cm=no pain and 10 cm=worse pain.|Day 15|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study medication and had at least one post baseline efficacy assessment.|||cm||Standard Deviation|Mean
2638352|NCT01774851|Primary|Progression Free Survival (PFS)|Target and non-target lesion antitumor response and disease progression during treatment with each dosing regimen will be evaluated using the international criteria proposed by the RECIST v1.1. Disease status will be assessed every 8 weeks from the date of the first dose of any drug in a regimen.|30 months||||weeks||95% Confidence Interval|Median
2638353|NCT01774799|Other Pre-specified|Burdensome Treatments|Burdensome treatments include: Hospitals transfers (hospitalizations or emergency room visits), tube feeding or parenteral therapy. The rate of burdensome treatments per 1000 resident days was compared between the intervention and control arms.|by 12 months||||Participants|||Count of Participants
2638354|NCT01774799|Other Pre-specified|Acquisition of Other Documented Advance Care Planning|The proportion of residents who acquired a documented advance directive to forego tube-feeding will be compared in the intervention versus control group.|by 6 months||||Participants|||Count of Participants
2638355|NCT01774799|Secondary|Acquisition of Preference for Level of Care|The proportion of proxies who have chosen comfort care (versus intermediate or intensive care) based on telephone interviews will be considered cumulatively at each assessment. At 6 months the outcome will include the proportion of proxies choosing comfort care up to and including the 6 month interview. Cumulative proportions will include data from the baseline interview for the control group, and baseline immediate post video interview for intervention group.The proportion of proxies choosing comfort care will be compared between the intervention and control groups using an extension of logistic regression based on general estimating equations (GEE) to account for clustering at the NH level at each time period.|6 months|Missing data are due to missing proxy interviews at certain follow-up time points|||Participants|||Count of Participants
2638356|NCT01774799|Secondary|Acquisition of Decisions Not to Hospitalize|This is a sub primary outcome. The modified ITT population will be the subgroup of residents who begin the study without a documented decision to forego hospitalization, and the outcome will be acquisition of a documented decision to forego hospitalization over the 12 month follow-up period. The analysis will utilize Cox proportional hazards regression. Results will be summarized using a hazard ratio and associated 95% confidence interval as well as plots of the cumulative incidence by group.|by 12 months||||Participants|||Count of Participants
2638398|NCT01774604|Secondary|Number of Patients Who Developed Mild Pancreatitis|Number of patient who developed mild acute pancreatitis based on the Atlanta Classification|From randomization to 30 days after ERCP||||participants|||Number
2638399|NCT01774604|Secondary|Number of Patients Who Developed Moderately Severe Pancreatitis|Number of patients with moderately severe pancreatitis based on Atlanta Classification|From randomization to 30 days after ERCP||||participants|||Number
2638357|NCT01774799|Primary|Documented Decisions to Forgo Hospitalization|"The proportion of residents with this outcome will be considered cumulatively at 6 months, including those who died; i.e., a composite of the percent of residents alive at six months who had a decision not to hospitalize and those who died before six months with this outcome prior to death. This cumulative outcome will only be based on time points following baseline as the baseline chart review data is conducted before the baseline proxy interview (i.e., before the proxy has seen the video in the intervention arm or heard options verbally in the control arm).~(Decisions to forehospitalizations will be examined in a similar fashion at 3, 9, and 12 months, however the six month time frame is the primary trial outcome)"|by six months||||Participants|||Count of Participants
2638358|NCT01774786|Secondary|Cmin of Trastuzumab||Pre-dose (0-6 hours before infusion) on D1 of Cycles 1, 2, 3, 4, 6, and 8; at 28 & 60-90 days (Post-Treatment [PT] Monitoring Visits 1 and 2, respectively) after D1 of last cycle (1 cycle = 21 days; up to approximately 3.5 years)|The pharmacokinetic analysis included all participants who were treated with study medication and who had at least one measurable concentration of pertuzumab or trastuzumab. Data are reported for evaluable participants.|||μg/mL||Standard Deviation|Mean
2638359|NCT01774786|Secondary|Minimum Serum Concentration (Cmin) of Pertuzumab||Pre-dose (0-6 hours before infusion) on D1 of Cycles 1, 2, 3, 4, 6, and 8; at 28 & 60-90 days (Post-Treatment [PT] Monitoring Visits 1 and 2, respectively) after D1 of last cycle (1 cycle = 21 days; up to approximately 3.5 years)|The pharmacokinetic analysis included all participants who were treated with study medication and who had at least one measurable concentration of pertuzumab or trastuzumab. Data are reported for evaluable participants.|||μg/mL||Standard Deviation|Mean
2638360|NCT01774786|Secondary|Cmax of Trastuzumab||Post-dose (0.5 hour after end of 30-60 minutes infusion) on D1 of Cycles 1, 2, 4, and 8 (1 cycle = 21 days; up to approximately 3.5 years)|The pharmacokinetic analysis included all participants who were treated with study medication and who had at least one measurable concentration of pertuzumab or trastuzumab. Data are reported for evaluable participants.|||μg/mL||Standard Deviation|Mean
2638361|NCT01774786|Secondary|Maximum Serum Concentration (Cmax) of Pertuzumab||Post-dose (0.5 hour after end of 30-60 minutes infusion) on Day (D1) of Cycles 1, 2, 4, and 8 (1 cycle = 21 days; up to approximately 3.5 years)|The pharmacokinetic analysis included all participants who were treated with study medication and who had at least one measurable concentration of pertuzumab or trastuzumab. Data are reported for evaluable participants.|||micrograms per milliliter (μg/mL)||Standard Deviation|Mean
2638362|NCT01774786|Secondary|Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score|The EORTC QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. A positive value means an increase, while a negative values means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).|Day 1 of each 21-day treatment cycle up to 28 and 60-90 days (post-treatment [PT] monitoring visits 1 and 2, respectively) after Day 1 of last treatment cycle (up to approximately 3.5 years)|Participants in the ITT population (includes all randomized participants, regardless of whether study medication was received) with both a baseline assessment and at least 1 post-treatment assessment are included in the analysis.|||score on a scale||Standard Deviation|Mean
2638363|NCT01774786|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score|The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).|Day 1 of each 21-day treatment cycle up to 28 and 60-90 days (post-treatment [PT] monitoring visits 1 and 2, respectively) after Day 1 of last treatment cycle (up to approximately 3.5 years)|Participants in the ITT population (includes all randomized participants, regardless of whether study medication was received) with both a baseline assessment and at least 1 post-treatment assessment are included in the analysis.|||score on a scale||Standard Deviation|Mean
2638364|NCT01774786|Secondary|Percentage of Participants With Left Ventricular Systolic Dysfunction (LVSD, Symptomatic or Asymptomatic)|Left ventricular systolic dysfunction may either be asymptomatic or have symptoms of heart failure. It is characterized by dilation of the left ventricle and vasoconstriction.|Baseline up to the 09 Dec 2016 data cutoff, approximately 3.5 years|The safety population included all participants who received any amount of any study medication.|||percentage of participants|||Number
2638365|NCT01774786|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.|Baseline up to the 09 Dec 2016 data cutoff, approximately 3.5 years|The safety population included all participants who received any amount of any study medication.|||percentage of participants|||Number
2638400|NCT01774604|Secondary|Number of Patients Who Developed Severe Pancreatitis|Number of patients with severe acute pancreatitis based on the Atlanta Classification|From randomization to 30 days after ERCP|Assess the number of patients who developed severe acute pancreatitis|||participants|||Number
2638401|NCT01774604|Primary|Number of Patients Who Developed Acute Pancreatitis|Number of patients who developed pancreatitis following ERCP based on Atlanta Classification|From randomization to 30 days after ERCP|Patient who randomized into the study and received either rectal indomethacin or placebo|||participants|||Number
2638402|NCT01774591|Primary|24-hour BP (Diastolic)|To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females.|26 weeks||||mmHg||Standard Deviation|Mean
2638366|NCT01774786|Secondary|Percentage of Participants With Clinical Benefit, as Determined by the Investigator According to RECIST v1.1 Criteria|Clinical benefit rate is defined as best response of CR or PR or stable disease for 6 weeks or longer, as determined by the investigator using RECIST v1.1. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Stable Disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum diameters while on study. Measurable disease is defined as tumor lesions measured in at least one dimension (longest diameter in plane of measurement) with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node to be considered pathologically enlarged and measurable, it must be >/=15 mm in short axis when assessed by CT scan.|Baseline up to death or disease progression, whichever occurs first (up to the 09 Dec 2016 data cutoff, approximately 3.5 years)|The subset of participants with measurable disease at baseline, according to RECIST v1.1 criteria.|||percentage of participants|||Number
2638367|NCT01774786|Secondary|Duration of Objective Response, as Determined by Investigator According to RECIST v1.1 Criteria|Duration of objective response is defined as the time from first occurrence of documented objective response to documented disease progression, as determined by the investigator using RECIST v1.1, or death from any cause. Objective response: PR or CR occurring on 2 consecutive occasions ≥4 weeks apart. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: disappearance of all target lesions. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions. Measurable disease defined as tumor lesions with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node, it must be ≥15 mm in short axis when assessed by CT scan.|Baseline up to death or disease progression, whichever occurs first (up to the 09 Dec 2016 data cutoff, approximately 3.5 years)|The participants with measurable disease at baseline who achieved a documented objective response, according to RECIST v1.1 criteria.|||months||95% Confidence Interval|Median
2638368|NCT01774786|Secondary|Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria|Overall objective response (partial response [PR] or complete response [CR]) occurring on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator using RECIST v1.1. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: disappearance of all target lesions. Measurable disease is defined as tumor lesions measured in at least one dimension (longest diameter in plane of measurement) with a minimum size of: 10 mm by computed tomography (CT) or magnetic resonance imaging (MRI) scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node to be considered pathologically enlarged and measurable, it must be greater than or equal to (≥) 15 mm in short axis when assessed by CT scan.|Baseline up to death or disease progression, whichever occurs first (up to the 09 Dec 2016 data cutoff, approximately 3.5 years)|The subset of participants with measurable disease at baseline, according to RECIST v1.1 criteria.|||Percentage of participants|||Number
2638369|NCT01774786|Secondary|Progression-Free Survival, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Criteria|Progression-free survival (PFS) is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using RECIST v1.1, or death from any cause. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 millimeters (mm) in the sum of diameters of target lesions; the appearance of one or more new lesions.|Baseline up to death or disease progression, whichever occurs first (up to the 09 Dec 2016 data cutoff, approximately 3.5 years)|The ITT population included all randomized participants, regardless of whether study medication was received.|||months||95% Confidence Interval|Median
2638370|NCT01774786|Primary|Overall Survival|Overall survival (OS) was defined as the time from randomization to death from any cause.|Baseline up to death (up to the 09 Dec 2016 data cutoff, approximately 3.5 years)|The intent-to-treat (ITT) population included all randomized participants, regardless of whether study medication was received.|||Months||95% Confidence Interval|Median
2638371|NCT01774760|Primary|Change From Baseline in 18F-EF5 Standardized Uptake Values (SUV)|Standardized Uptake Values (SUV) are determined in the acquisition images of the [18F]EF5 studies.The difference between the baseline and second SUV is calculated and Bland-Altman plots are generated to compare the group means|Baseline and 7 days (ie time between the two scans)|Head and neck squamous cell carcinoma|||SUVmax||Standard Deviation|Mean
2638372|NCT01774721|Secondary|Pre-dose Plasma Concentrations (Ctrough) of Dacomitinib and Its Metabolite PF-05199265|Trough plasma concentration was defined as the measured concentration at the end of a dosing interval at steady state (taken directly before next administration).|Pre-dose on Day 1 of Cycle 2, 3, 4, 5 and 6|PK analysis set included all participants who were treated with dacomitinib with at least one measured plasma concentration and were dose-compliant. Dose-compliant participants were those who received 45 mg dacomitinib daily without interruptions or dose reductions for at least 14 days prior to the day of data collection.|||ng/mL||Standard Deviation|Mean
2638373|NCT01774721|Secondary|Apparent Clearance (CL) of Dacomitinib|Drug clearance was a quantitative measure of the rate at which a drug substance was removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes).|Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)|PK analysis set included all participants who were treated with dacomitinib with at least 1 measured plasma concentration and were dose-compliant (who received 45 mg dacomitinib daily without interruptions/dose reductions for at least 14 days prior to day of data collection). This outcome measure was planned to be analyzed in Chinese subgroup only.|||Liter/hour (L/h)||Standard Deviation|Mean
2638403|NCT01774591|Secondary|Difference in 24-hour Urine Aldosterone Change From Baseline|To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on urinary aldosterone levels in postmenopausal females|26 weeks||||percentage of changes||Standard Deviation|Mean
2638404|NCT01774591|Primary|24-hour BP (Systolic)|To evaluate the effect of an angiotensin receptor blocker (azilsartan medoximil) on blood pressure in postmenopausal females.|26 weeks||||mmHg||Standard Deviation|Mean
2638374|NCT01774721|Secondary|Fluctuation Coefficient Between Trough and Peak Plasma Concentration (DF) of Dacomitinib and Its Metabolite PF-05199265|Fluctuation coefficient between trough and peak plasma concentration was determined as Cmax-Ctrough divided by Cavg, where Cmax was the maximum observed concentration within the dosing interval, Ctrough was the observed concentration prior to dose administration and Cavg was averaged plasma concentration at steady state.|Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)|PK analysis set included all participants who were treated with dacomitinib with at least 1 measured plasma concentration and were dose-compliant (who received 45 mg dacomitinib daily without interruptions/dose reductions for at least 14 days prior to day of data collection). This outcome measure was planned to be analyzed in Chinese subgroup only.|||Fluctuation coefficient||Standard Deviation|Mean
2638375|NCT01774721|Secondary|Minimum Observed Plasma Concentration (Cmin) of Dacomitinib and Its Metabolite PF-05199265||Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)|PK analysis set included all participants who were treated with dacomitinib with at least 1 measured plasma concentration and were dose-compliant (who received 45 mg dacomitinib daily without interruptions/dose reductions for at least 14 days prior to day of data collection). This outcome measure was planned to be analyzed in Chinese subgroup only.|||ng/mL||Standard Deviation|Mean
2638376|NCT01774721|Secondary|Averaged Plasma Concentration at Steady State (Cavg) of Dacomitinib and Its Metabolite PF-05199265||Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)|PK analysis set included all participants who were treated with dacomitinib with at least 1 measured plasma concentration and were dose-compliant (who received 45 mg dacomitinib daily without interruptions/dose reductions for at least 14 days prior to day of data collection). This outcome measure was planned to be analyzed in Chinese subgroup only.|||ng/mL||Standard Deviation|Mean
2638377|NCT01774721|Secondary|Area Under the Plasma Concentration-Time Curve From Time 0 to End of Dosing Interval (AUCtau) of Dacomitinib and Its Metabolite PF-05199265||Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)|PK analysis set included all participants who were treated with dacomitinib with at least 1 measured plasma concentration and were dose-compliant (who received 45 mg dacomitinib daily without interruptions/dose reductions for at least 14 days prior to day of data collection). This outcome measure was planned to be analyzed in Chinese subgroup only.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
2638378|NCT01774721|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Dacomitinib and Its Metabolite PF-05199265||Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)|PK analysis set included all participants who were treated with dacomitinib with at least 1 measured plasma concentration and were dose-compliant (who received 45 mg dacomitinib daily without interruptions/dose reductions for at least 14 days prior to day of data collection). This outcome measure was planned to be analyzed in Chinese subgroup only.|||hour||Full Range|Median
2638379|NCT01774721|Secondary|Maximum Observed Plasma Concentration (Cmax) of Dacomitinib and Its Metabolite PF-05199265||Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)|PK analysis set included all participants who were treated with dacomitinib with at least 1 measured plasma concentration and were dose-compliant (who received 45 mg dacomitinib daily without interruptions/dose reductions for at least 14 days prior to day of data collection). This outcome measure was planned to be analyzed in Chinese subgroup only.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2638380|NCT01774721|Secondary|Overall Mean Scores of Euro Quality of Life-5 Dimension Visual Analog Scale (EQ-5D VAS)|The Euro Quality of Life-5 dimension (EQ-5D) is a brief self-administered, validated reliable generic health status instrument. EQ-5D general health status can also be measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).|From Cycle 1 to 41 (up to 48 months)|PRO analysis set included all enrolled participants, who started treatment and completed a baseline PRO assessments and at least one post-baseline PRO assessment after the first dose.|||units on a scale||95% Confidence Interval|Mean
2638381|NCT01774721|Secondary|Health Related Quality of Life (HRQOL): Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough|HRQOL was measured by standardized questionnaires (European Organization for Research and Treatment of Cancer (EORTC)) quality of life questionnaires (OLQ-C30) and its lung cancer module (QLQ-LC13). TTD in pain (chest, arm/shoulder), dyspnea, fatigue or cough was defined as time between baseline and first occurrence of increase in score of 10 points or greater from baseline in any of these 4 symptoms for at least two consecutive cycles. For those who had not shown deterioration, the data was censored at the last date when the participants completed an assessment for pain, dyspnea, fatigue or cough.|Baseline until the end of treatment (up to 48 months)|PRO analysis set included all enrolled participants, who started treatment and completed a baseline PRO assessments and at least one post-baseline PRO assessment after the first dose.|||months||95% Confidence Interval|Median
2638382|NCT01774721|Secondary|Number of Participants With Maximum Relative Decrease From Baseline >20% in Left Ventricular Ejection Fraction (LVEF)|An ejection fraction (EF) was the volumetric fraction of blood ejected from a ventricle of the heart with each heartbeat; it was a measure of the pumping efficiency of the heart. The EF of the left heart, known as the left ventricular ejection fraction, was a measure of the efficiency of pumping into the body's systemic circulation.|From baseline up to 7 days of Cycle 4 (up to 91 days)|Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received. Here “N” signifies number of participants who were evaluable for this specified outcome measure.|||participants|||Number
2638383|NCT01774721|Secondary|Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)|ECG parameters included corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria for abnormality: absolute value 450 - <480 msec, 480 - <500 msec >=500. The number of participants with potentially clinically significant ECG findings at any visit were reported.|From baseline up to 28-35 days after last dose of study drug (up to 48 months)|"Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received. Here, N (number of participants analyzed) signifies participants who were evaluable for this specified outcome measure."|||participants|||Number
2638978|NCT01769196|Primary|PFS Among the Participants With sLOXL2 ≥ 75th Percentile||Up to 148 weeks|Participants in the ITT Analysis Set with sLOXL2 ≥ 75th percentile in peripheral blood were analyzed.|||months||95% Confidence Interval|Median
2638384|NCT01774721|Secondary|Number of Participants With Clinically Significant Abnormalities in Vital Signs|Criteria for vital signs abnormalities: systolic pulse rate less than (<) 50 beats per minute (bpm) or greater than (>)130 bpm and maximum increase or decrease from baseline in pulse rate of 30 bpm. Systolic blood pressure of maximum increase from baseline (MIB) >=40 millimeters of mercury (mmHg), maximum decrease from baseline (MDB) in systolic blood pressure =<60 mmHg. Diastolic blood pressure of MIB >=20 mmHg and MDB in diastolic blood pressure >40 and =<20 mm Hg. Only categories with at least 1 participant with abnormality are reported in this outcome measure.|From baseline up to 28-35 days after last dose of study drug (up to 48 months)|Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.|||Participants|||Count of Participants
2638385|NCT01774721|Secondary|Number of Participants With Laboratory Test Abnormalities: Urinalysis|Urinalysis parameter included urine protein, urine blood/haemoglobin, urine glucose and urine sediment. Test abnormalities was defined as deviation from normal range (higher or lower). Normal range of 24-hour urine protein test: less than 150 mg of protein per day, urine glucose: 0 to 0.8 mmol/L (millimole per liter), urine protein: 0 to 20 mg/dL (milligrams per deciliter). Urine blood/haemoglobin abnormality was defined as presence and absence of blood/haemoglobin in urine of participants. Urine sediment abnormality was defined as the presence of any bacteria, casts, crystals, and epithelial cells. Only categories with at least 1 participant with abnormality are reported in this outcome measure.|From baseline up to 28-35 days after last dose of study drug (up to 48 months)|Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.|||Participants|||Count of Participants
2638386|NCT01774721|Secondary|Number of Participants With Laboratory Test Abnormalities of Grade 3 or Higher Severity Based on NCI CTCAE Version 4.03: Biochemistry and Haematology|Laboratory parameters included haematological and biochemistry parameters. Haematology parameters included anaemia, activated partial thromboplastin time, haemoglobin, international normalized ratio, lymphocyte count, lymphopenia, neutrophils (absolute), platelets, prothrombin time and white blood cells. Biochemistry parameters included alanine aminotransferase (increased), alkaline phosphatase (increased), aspartate aminotransferase (increased), bilirubin (total), creatinine (increased), hypercalcaemia, hyperglycaemia, hyperkalaemia, hypermagnesaemia, hypernatraemia, hypoalbuminaemia, hypocalcaemia, hypoglycaemia, hypokalaemia, hypomagnesaemia, hyponatraemia. Test abnormalities were graded by AEs according to the Common Terminology Criteria for Adverse Events(NCI CTCAE) version 4.03 as Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Only categories with at least 1 participant with abnormality are reported in this outcome measure.|From baseline up to 28-35 days after last dose of study drug (up to 48 months)|Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.|||Participants|||Count of Participants
2638387|NCT01774721|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between first dose of study drug and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non- serious adverse events.|From baseline up to 28-35 days after last dose of study drug (up to 48 months)|Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.|||participants|||Number
2638388|NCT01774721|Secondary|Duration of Response (DoR)|DoR was defined as time from first documentation of objective response(CR or PR, whichever occurred first)to date of PD or death from any cause, whichever occurred first. CR for target lesion: disappearance of all target lesions with exception of nodal disease. All target nodes decreased to normal size(short axis <10 mm); for non-target lesions: disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be 'normal' in size(<short axis <10 mm); for new lesions:repeated assessments of new lesion if it was equivocal. PR: >=30% decrease under baseline of sum of all target measurable lesions, short diameter used in sum for target nodes, longest diameter used in sum for all other target lesions. PD: 20% increase in sum of diameters of target measurable lesions above the smallest sum observed(over baseline if no decrease in sum is observed),with a minimum absolute increase of 5 mm. DoR was recorded based on IRC review and investigator's assessment.|Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression or death due to any cause, whichever occurred first (up to 48 months)|ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.|||months||95% Confidence Interval|Median
2638389|NCT01774721|Secondary|Objective Response Rate (ORR) Based on Investigator Assessment|Percentage of participants with a BOR of either CR or PR based on investigator assessment recorded from the start of treatment until disease progression based on RECIST v1.1. CR for target lesion: disappearance of all target lesions with exception of nodal disease. All target nodes must decreased to normal size (short axis <10 mm); for non-target lesions: disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be 'normal' in size (<short axis <10 mm); for new lesions: repeated assessments of a new lesion if it was equivocal. PR: >=30% decrease under baseline of sum of all target measurable lesions, short diameter was used in sum for target nodes, longest diameter was used in sum for all other target lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.|Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression (up to 48 months)|ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
2651439|NCT01662102|Secondary|Time to Progression (TTP)|TTP is defined as the time from randomization to the first disease progression.|Up to 7 years|||||||
2638390|NCT01774721|Secondary|Objective Response Rate (ORR) Based on IRC Review|Percentage of participants with a BOR of either CR or PR based on IRC review recorded from the start of treatment until disease progression based on RECIST v1.1. CR for target lesion: disappearance of all target lesions with exception of nodal disease. All target nodes must decreased to normal size (short axis <10 mm); for non-target lesions: disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be 'normal' in size (<short axis <10 mm); for new lesions: repeated assessments of a new lesion if it was equivocal. PR: >=30% decrease under baseline of sum of all target measurable lesions, short diameter was used in sum for target nodes, longest diameter was used in sum for all other target lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.|Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression (up to 48 months)|ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.|||percentage of participants||95% Confidence Interval|Number
2638391|NCT01774721|Secondary|Number of Participants With Best Overall Response (BOR) Based on Investigator Assessment|Number of participants with BOR based on investigator assessment (CR or confirmed PR) was recorded from randomization until disease progression based on RECIST v1.1. CR for target lesion: disappearance of all target lesions with exception of nodal disease. All target nodes must decreased to normal size (short axis <10 mm); for non-target lesions: disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be 'normal' in size (<short axis <10 mm); for new lesions: repeated assessments of a new lesion if it was equivocal. PR: >=30% decrease under baseline of sum of all target measurable lesions, short diameter was used in sum for target nodes, longest diameter was used in sum for all other target lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.|Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression (up to 48 months)|ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.|||Participants|||Count of Participants
2638392|NCT01774721|Secondary|Number of Participants With Best Overall Response (BOR) Based on IRC Review|Number of participants with BOR based on IRC review(complete response[CR] or confirmed partial response[PR]) was recorded from randomization until disease progression based on RECISTv1.1. CR for target lesion: disappearance of all target lesions with exception of nodal disease. All target nodes must decreased to normal size(short axis <10 mm); for non-target lesions: disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be 'normal' in size(<short axis <10 mm); for new lesions: repeated assessments of a new lesion if it was equivocal. PR: >=30% decrease under baseline of sum of all target measurable lesions, short diameter was used in sum for target nodes, longest diameter was used in sum for all other target lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.|Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression (up to 48 months)|ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.|||Participants|||Count of Participants
2638393|NCT01774721|Secondary|Progression Free Survival (PFS) Based on Investigator Assessment|PFS: time from randomization to date of PD as determined by investigator assessment as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or death due to any cause, whichever occurred first. PD for target lesions: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm; for non-target lesions: unequivocal progression of pre-existing lesions. Overall tumor burden increased sufficiently to merit discontinuation of therapy. In presence of stable disease (did not achieve partial response, complete response or PD) or partial response (>=30% decrease under baseline of sum of diameters of all target measurable lesions, short diameter used in the sum for target nodes, longest diameter used in sum for all other target lesions) in target disease; for new lesions: appearance of any new unequivocal malignant lesion indicated PD.|Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression or death due to any cause, whichever occurred first (up to 48 months)|ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.|||months||95% Confidence Interval|Median
2638394|NCT01774721|Primary|Progression Free Survival (PFS) Based on Independent Radiologic Central (IRC) Review|PFS: time from randomization to date of progression of disease (PD) as determined by IRC review as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or death due to any cause, whichever occurred first. PD for target lesions: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm; for non-target lesions: unequivocal progression of pre-existing lesions. Overall tumor burden increased sufficiently to merit discontinuation of therapy. In presence of stable disease (did not achieve partial response, complete response or PD) or partial response (>=30% decrease under baseline of sum of diameters of all target measurable lesions, short diameter used in the sum for target nodes, longest diameter used in sum for all other target lesions) in target disease; for new lesions: appearance of any new unequivocal malignant lesion indicated PD.|Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression or death due to any cause, whichever occurred first (up to 48 months)|ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.|||months||95% Confidence Interval|Median
2638395|NCT01774604|Secondary|Number of Patients With 30 Days Hospital Re-admission|Number of patients admitted to the hospital for any cause following ERCP|From randomization until 30 days after ERCP||||participants|||Number
2638396|NCT01774604|Secondary|Number of Patient Deaths|Number of patients who died from any cause from the time of ERCP until 30 days post-procedure|From randomization to 30 days after ERCP||||participants|||Number
2638406|NCT01774370|Secondary|Percentage of Participants With Stroke|Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction.|up to 26 weeks|Effectiveness Analysis set: Effectiveness analysis will be performed to the patients who have been on Pradaxa more than 12 weeks (in case of long-term follow up, 24 weeks).|||percentage of participants|||Number
2638407|NCT01774370|Primary|Occurrence of Adverse Events(Including Unexpected Adverse Events, Serious Adverse Events, Drug-related Adverse Events, Adverse Events Leading to Discontinuation and Adverse Events by Intensity, Outcome of the Event, Causality)|"Occurrence of adverse events(Including unexpected adverse events, serious adverse events, drug-related adverse events, adverse events leading to discontinuation and adverse events by intensity, outcome of the event, causality).~Number analyzed presents the Number of participants with Adverse events"|up to 26 weeks|Safety analyses will be based on all patients treated, i.e. all patients who received at least one dose of Pradaxa.|||Adverse events|||Number
2638408|NCT01774344|Secondary|Disease Control Rate (DCR)|Disease control rate (DCR) was defined as the percentage of subjects whose best response was CR (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).), PR (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.), or stable disease (SD) (SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to RECIST and RECIST 1.1 criteria. SD had to be maintained for at least 6 weeks from the first demonstration of that rating.|From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months)||||percentage of subjects|||Number
2638409|NCT01774344|Secondary|Objective Tumor Response Rate (ORR)|Objective tumor response rate (ORR) was defined as the percentage of subjects whose best tumor response CR or Partial Response (PR) observed during trial period assessed according to the mRECIST criteria and RECIST 1.1. CR= Disappearance of all clinical and radiological evidence of tumor (both target and non-target). Any pathological lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non target lesions and no appearance of new lesions. Subjects prematurely discontinuing without an assessment were to be considered non-responders for the analysis.|From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months)||||percentage of subjects|||Number
2638410|NCT01774344|Secondary|Progression Free Survival (PFS)|Progression Free Survival (PFS) was defined as the time (days) from date of randomization to date of disease progression (radiological or clinical) or death due to any cause, if death occurs before progression was documented. Death in the absence of progression was a PFS event only if it occurred within the 12+1 weeks for subjects who discontinued treatment prior to cycle 8 and 24+2 weeks for subjects who discontinued treatment after to cycle 8 of the last evaluable tumor assessment; PFS were censored at the date of the last evaluable tumor assessment, if it occurred later. Median and 95% confidence interval 95% were reported for the mRECIST and RECIST 1.1 analysis sets. Subjects still alive at the time of analysis were censored at their last date of last contact.|From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks)||||days||95% Confidence Interval|Median
2638411|NCT01774344|Secondary|Time to Progression (TTP)|TTP was the time (days) from randomization to radiological or clinical disease progression assessed by independent radiological review. Median and 95% confidence interval were reported for the modified response evaluation criteria in solid tumors (mRECIST) and response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) analysis sets. Subjects still alive at the time of analysis were censored at their last date of last contact.|From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months)||||days||95% Confidence Interval|Median
2638412|NCT01774344|Primary|Overall Survival (OS)|Overall Survival (OS) was defined as the time from date of randomization (Day 1) to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|From randomization (Day 1) of the first subject until 419 days later||||days||95% Confidence Interval|Median
2638413|NCT01774305|Secondary|Emergence Time|The emergence time will be recorded as the time from sevoflurane discontinuation to eye opening on command.|from sevoflurane discontinuation, up to the time of eye opening (estimated time : from 5 min to 10 min)||||sec||Standard Deviation|Mean
2638414|NCT01774305|Primary|Coughing Grade|The coughing incidence and severity will be measured at extubation. Especially from the time of eye opening to 5 min after extubation. The coughing grade was assessed by the following cough grading system: Grade 0, no cough or single, mild cough at extubation; Grade 1, multiple, not sustained cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking).|from the time of eye opening to 5 min after extubation||||units on a scale||Standard Deviation|Mean
2638415|NCT01774253|Secondary|Determine the Response Rates of Participants Based on Activation (or no Activation) of Their Hedgehog Signaling Pathway|To determine the objective response rates (partial and complete response) for patients without and with evidence of activation of Hedgehog signaling pathway in their tumors|3 years|No samples collected for hedgehog pathway. No data exists.||||||
2638416|NCT01774253|Secondary|Evaluate the Impact of Quality of Life of Children Receiving Vismodegib Using PedsQL Questionnaires|Evaluate the impact of Quality of Life of children receiving Vismodegib using PedsQL questionnaires|2 years|QOL's not collected due to early closure of study. Data not collected or analyzed threfore no data exists.||||||
2638417|NCT01774253|Secondary|Determine the Median Overall Survival (OS) of Participants|Overall Survival (OS) and clinical benefit (ORR + stable disease, SD)|2 years|Not evaluated due to early closure. Study data does not exist.||||||
2638418|NCT01774253|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|To determine the safety and tolerability of Vismodegib as a single agent in pediatric and young adult patients with refractory or recurrent pontine glioma|2 years||||participants|||Number
2638422|NCT01774149|Secondary|Change in HbA1c|HbA1c will be measured at the start of the study (week 1 post-enrollment) and during the last week of intervention (week 12 for the intervention group and week 20 for the active comparator group).|up to 20 weeks post-enrollment|11 participants in each group met for measurement of HbA1c. Reasons for not meeting was not recorded.|||Percentage points||95% Confidence Interval|Mean
2638423|NCT01774149|Primary|Change in the Frequency of Hyper- and Hypo-glycemic Events From Baseline to Week 8-12.|The number of self-measured blood glucose values < 4 mmol/L (72 mg/dL) or > 15 mmol/L (270 mg/dL) will be recorded during baseline (first 4 weeks post-enrollment/start of study) and during weeks 8-12 post-enrollment for all participants.|Up to 12 weeks post-enrollment|14 participants in each group were active users and had sufficient data to be analyzed for the outcome.|||Events||95% Confidence Interval|Mean
2638424|NCT01774110|Other Pre-specified|Change in 6-Minute Walk Test Distance From Time of Discharge From Rehabilitation (Initial Assessment) to 6 Months Post Enrollment|The 6-Minute Walk Test is a test of walking endurance and walking velocity.|This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment||||feet||Standard Deviation|Mean
2638425|NCT01774110|Secondary|Change in Score on Stroke Rehabilitation Assessment of Movement (STREAM) Test From Initial Assessment to Discharge From Study.|The Stroke Rehabilitation Assessment of Movement (STREAM) is a test of motor recovery after stroke. There are 3 subsections of the test, an upper extremity section, a lower extremity section and a mobility section. Each section is scored independently and is normed to 100 points. Each of the 3 sections is then combined into a total overall function score which is also normed to 100. Therefore, a score of 100 represents full recovery whereas a score of 50 represents about 50% recovery from the stroke.|This test will be done at the initiation of the protocol (initial assessment) and at 6 months post enrollment||||scores on a scale||Standard Deviation|Mean
2638426|NCT01774110|Primary|Change in Walking Velocity From Initial Assessment to Completion of Study at 6 Months Post Enrollment|Computerized gait analysis is done by a mat system (GAITRite) that electronically calculates the velocity.|This will be done at the time of discharge from inpatient rehabilitation (the initial assessment point of the study) and at 6-months post enrollment.||||cm/sec||Standard Deviation|Mean
2638427|NCT01774097|Secondary|Walking Impairment Questionnaire (WIQ)-Ability to Climb Stairs Score|The Walking Impairment Questionnaire (WIQ) assesses the severity of the subjective walking impairment on distance, speed, and stair climbing scales. It is administered as a self report. Range: Minimum score is 0, maximum 100. The measure represents the placebo adjusted average change in WIQ ability to climb stairs score assessed over time. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)|Participants who had available analyzable baseline, 1 month, 3 month, and 6 month WIQs|||scores on a scale||Standard Deviation|Mean
2638428|NCT01774097|Secondary|Walking Impairment Questionnaire (WIQ)- Walking Speed Score|The Walking Impairment Questionnaire (WIQ) assesses the severity of the subjective walking impairment on distance, speed, and stair climbing scales. It is administered as a self report. Range: Minimum score is 0, maximum 87. The measure represents the placebo adjusted average change in WIQ walking speed score assessed over time. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)|Participants who had available analyzable baseline, 1 month, 3 month, and 6 month WIQs|||scores on a scale||Standard Deviation|Mean
2638429|NCT01774097|Secondary|Walking Impairment Questionnaire (WIQ)-Walking Distance Score|The Walking Impairment Questionnaire (WIQ) assesses the severity of the subjective walking impairment on distance, speed, and stair climbing scales. It is administered as a self report. Range: Minimum score is 0.2, maximum 100. The measure represents the placebo adjusted average change in WIQ walking distance score assessed over time. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)|Participants who had available analyzable baseline, 1 month, 3 month, and 6 month WIQs.|||scores on a scale||Standard Deviation|Mean
2638430|NCT01774097|Secondary|Peripheral Artery Questionnaire (PAQ)|The Peripheral Artery Questionnaire (PAQ) assesses subjective physical limitations, leg symptoms, social function, treatment satisfaction, and quality of life. It is administered as a self report. Higher scores are indicative of better outcome. The summary scores is compiled by taking the mean of five subscales generated from the original questions. Range: Minimum score is 11.1, maximum 85. The measure represents placebo adjusted average change in Peripheral Artery Questionnaire (PAQ) summary score assessed over time. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)|Participants who had available analyzable baseline, 1 month, 3 month, and 6 month PAQs.|||scores on a scale||Standard Deviation|Mean
2638431|NCT01774097|Secondary|Peak Walking Time (PWT)|The average change in maximum time (in minutes) walked by a patient on a treadmill under standardized conditions. The patient continues the test until walking can no longer be tolerated because of claudication symptoms.|Assessed at baseline and 3 months|Participants who had available analyzable baseline, 3 month, and 6 month treadmill test results.|||minutes||Standard Deviation|Mean
2638432|NCT01774097|Secondary|Claudication Onset Time (COT)|Claudication Onset Time (COT) is the walking time at which patients first experience leg pain during a treadmill test. The measure represents placebo adjusted average change over time (in minutes) in the time walked by a patient on a treadmill under standardized conditions before the onset of claudication symptoms, regardless of whether this is manifested or characterized as muscle pain, ache, cramp, numbness or fatigue. This does not include joint pain or other pain not associated with claudication. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 3mos, and 6 mos)|Participants who had available analyzable baseline, 3 month, and 6 month treadmill test results.|||minutes||Standard Deviation|Mean
2638555|NCT01772719|Secondary|Progression Free Survival (PFS)|Study will estimate PFS when there is one year of follow up data for all surviving participants|At start of year 2 follow up on all surviving participants|Study was terminated and PI has left the institution. Sincere efforts were made to gather and report the data, however, no data is available for the study||||||
2638433|NCT01774097|Secondary|Post-exercise Ankle-Brachial Index (ABI)|ABI is the ratio of the blood pressure at the ankle to the blood pressure of the upper arm. Post-exercise ABI is collected routinely with the patient supine immediately following a treadmill test. This measure represents the placebo adjusted average change over time in arm and pedal (ankle) blood pressure. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 3mos, and 6 mos)|Participants with available analyzable ABI at baseline, 3 months, and 6 months|||ratio||Standard Deviation|Mean
2638434|NCT01774097|Secondary|Pre-exercise Ankle-Brachial Index (ABI)|ABI is the ratio of the blood pressure at the ankle to the blood pressure of the upper arm. Pre-exercise ABI is collected routinely with the patient supine immediately prior to a treadmill test. This measure represents the placebo adjusted average change over time in arm and pedal (ankle) blood pressure. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.|Assessed as a trajectory (baseline, 3mos, and 6 mos)|Participants with available analyzable ABI data at baseline, 3 months, and 6 months|||ratio||Standard Deviation|Mean
2638435|NCT01774097|Primary|Capillary Perfusion|The placebo adjusted average change in capillary perfusion over time.|Assessed at baseline and 6 months|Participants with available analyzable MRI imaging at baseline and 6 months|||percent||Standard Deviation|Mean
2638436|NCT01774097|Primary|Peak Hyperemic Popliteal Flow (Phase Contrast MRA)|The placebo adjusted average change in peak hyperemic popliteal flow (mL/s) over time.|Assessed at baseline and 6 months|Participants who had available analyzable baseline and 6 month MRI imaging|||ml/sec||Standard Deviation|Mean
2638437|NCT01774097|Primary|Leg Collateral Count (Via Contrast Enhanced-MR)|The placebo adjusted average change in the number of collateral vessels over time.|Assessed at baseline and 6 months|Participants who had available analyzable baseline and 6 month MRI imaging|||vessel count||Standard Deviation|Mean
2638438|NCT01774097|Primary|Peak Walking Time (PWT)|The placebo adjusted average change over time in the maximum time (in minutes) walked by a patient on a treadmill under standardized conditions. The patient continues the test until walking can no longer be tolerated because of claudication symptoms.|Assessed at baseline and 6 months|Participants who had available analyzable baseline and 6 month treadmill test results.|||minutes||Standard Deviation|Mean
2638439|NCT01774084|Secondary|Change in Beta Cell Function|Beta cell function is measured with intravenous glucose tolerance test (IVGTT)|Morning before surgery and up to two days after surgery||||Insulin AUC nmol * min/L||Standard Deviation|Mean
2638440|NCT01774084|Primary|Change in Insulin Sensitivity|Insulin sensitivity is measured by euglycemic hyperinsulinemic clamp|Morning before surgery and up to two days after surgery|Per protocol|||mg/(kg min)||Standard Deviation|Mean
2638441|NCT01774045|Primary|Number of Dose Limiting Toxicity of Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is composed of suicidal ideation, intensity of ideation and suicidal behavior and measured at each visit.|baseline to 72 hours||||participants|||Number
2638442|NCT01774045|Primary|Number of Dose Limiting Toxicity of Laboratory Values|Laboratory tests are composed of hematology and blood chemistry and measured at each visit. Hematology are composed of RBC, WBC, platelets, hematocrit, hemoglobin, prothrombin time (PT) and partial thromboplastin time (aPTT). Blood chemistry are composed of AST, ALT, LDH, total bilirubin, BUN, serum creatinine, free thyroxine (FT4), TSH, sodium, calcium, potassium, glucose, LDL, HDL, cholesterol and HbA1c.|baseline to 72 hours||||participants|||Number
2638443|NCT01774045|Primary|Number of Dose Limiting Toxicity of Vital Sign|Vital sign, including heart rate, blood pressure and body temperature, are measured at each visit and at 1,2,3,4,8,12 and 24 hours after drug administration.|baseline to 72 hours||||participants|||Number
2638444|NCT01774045|Primary|Number of Dose Limiting Toxicity of Electrocardiograph|Electrocardiograph (ECG) is measured at each visit. At visit 2, subjects were measured at 1,2, 4, 8, 12 and 24 hours after drug administration.|baseline to 72 hours||||participants|||Number
2638445|NCT01774045|Primary|Number of Dose Limiting Toxicity of Physical Examination|Physical examination, including skin, head, neck, eyes, ears, nose, throat, heart, lungs, abdomen (liver and spleen), neurological examination, lymph node and extremities, is measured at each visit from screening to follow-up.|baseline to 72 hours||||participants|||Number
2638446|NCT01773993|Secondary|Change From Baseline in the Japanese Version of the Revised Fibromyalgia Impact Questionnaire (JFIQR) at 52 Weeks|"JFIQR is a Japanese version of the Revised Fibromyalgia Impact Questionnaire (FIQR), which was established for overall evaluation of the influence of fibromyalgia on patient's health. It consists of three linked sets of domains: function (9 questions), overall impact (2 questions), and symptoms (10 questions). Participants responded to the questions based on an 11-grade scale, ranging from 0 to 10, with 10 being the worst. For the analysis of JFIQR, the score for each domain was modified as follows: The summed score for function (ranged from 0 to 90) was divided by 3 and the summed score for symptoms (ranged from 0 to 100) was divided by 2. The summed score for overall impact (ranged from 0 to 20) was not modified. The total score, the sum of the three modified domain scores (ranged from 0 to 100, the lower score represents a better outcome), was used for the analysis. Mean change from baseline in the evaluation score was presented along with standard deviation."|At Week 52|The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of JFIQR was available among the baseline analysis population.|||Units on a scale||Standard Deviation|Mean
2638447|NCT01773993|Secondary|Change From Baseline in Fibromyalgia Activity Score (FAS-31) at 52 Weeks|FAS-31 (ranged from 0 to 31) is calculated as the combined score of the widespread pain index (WPI, ranged from 0 to 19) and the symptom severity (SS) scale (ranged from 0 to 12). The WPI is a measure of the number of painful body regions. The SS is the scale of the severity in the three symptoms (fatigue, waking unrefreshed, and cognitive symptoms; ranged from 0 to 3 each) and general physical symptoms (ranged from 0 to 3). WPI ranged from 0 to 19 the higher score indicates more severe of activity, SS ranged from 0-12 also higher score shows more severe symptoms observed. Mean change from baseline in the evaluation score was presented along with standard deviation.|At Week 52|The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of FAS-31 was available among the baseline analysis population.|||Units on a scale||Standard Deviation|Mean
2652089|NCT01656252|Secondary|Phase II- Depth of Platelet Nadir|To determine the impact of eltrombopag on the depth of platelet nadir following a cycle of consolidation chemotherapy.|62 months|||||||
2638448|NCT01773993|Secondary|Change From Baseline in Health Status of EuroQol 5 Dimension (EQ-5D) at 52 Weeks|"Health status (EQ-5D) was evaluated based on the following 5 dimensions: mobility, self-care, usual activity (e.g., work, study, housework, family, or leisure activities), pain/discomfort, and anxiety/depression. Each dimension was rated in the three levels of response alternatives no problems, some problems, or extreme problems. For the analysis of EQ-5D, the response outcome for the five dimensions was converted to a utility value using tariff value set based on the Japanese version of EQ-5D. The utility value was not assigned if there was no response in any one of the five dimensions. 1 for full health and 0 for being dead: a positive (negative) number implies that the health state is better (worse) than dead. Mean change from baseline in the evaluation score was presented along with standard deviation."|Baseline and at Week 52|The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of EQ-5D was available among the baseline analysis population.|||Units on a scale||Standard Deviation|Mean
2638449|NCT01773993|Secondary|Change From Baseline in Patient Health Questionnaire (PHQ-9) Score at Week 52|The problems associated with depression-related symptoms experienced during the last 2 weeks were rated by participants ranging from 0 (not at all) to 3 (nearly every day) in total 0 to 27(the higher the more severe) consisting the following 9 items: 1) little interest or pleasure in doing things; 2) depressed, or hopeless; 3) trouble falling or staying asleep, or sleeping too much; 4) feeling tired or having little energy; 5) poor appetite or overeating; 6) feeling bad about yourself - or that you are a failure or have let yourself or your family down; 7) trouble concentrating on things, such as reading the newspaper or watching television; 8) moving or speaking so slowly that other people could have noticed. Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual; and 9) thoughts that you would be better off dead, or of hurting yourself. Mean change from baseline in the evaluation score was presented along with standard deviation.|Baseline and at Week 52|The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of PHQ-9 was available among the baseline analysis population.|||Units on a scale||Standard Deviation|Mean
2638450|NCT01773993|Secondary|Physician's Impression (CGIC) at Week 52|The physician's impression (clinical global impression of change [CGIC]) at Week 52, as compared to the baseline condition (including the first day of treatment), was rated by the physician on a 7-grade scale.|At Week 52|The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of CGIC was available among the baseline analysis population.|||Participants|||Number
2638451|NCT01773993|Secondary|Patient's Impression (PGIC) at Week 52|The patient's impression (patient global impression of change [PGIC]) at Week 52, as compared to the baseline condition (including the first day of treatment), was rated by participants on a 7-grade scale.|At Week 52|The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of PGIC was available among the baseline analysis population.|||Participants|||Number
2638452|NCT01773993|Secondary|Change From Baseline in Quality of Sleep Score at Week 52|The quality of sleep experienced during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (the best sleep possible) to 10 (the worst sleep possible). Mean change from baseline in quality of sleep score at Week 52 was presented along with standard deviation.|Baseline and at Week 52|The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of quality of sleep score was available among the baseline analysis population.|||Units on a scale||Standard Deviation|Mean
2638453|NCT01773993|Secondary|Change From Baseline in Pain Score at Week 52|The pain from fibromyalgia experienced during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no pain) to 10 (the most severe pain possible). Mean change from baseline in the pain score at Week 52 was presented along with standard deviation.|Baseline and at Week 52|The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of pain score was available among the baseline analysis population.|||Units on a scale||Standard Deviation|Mean
2638454|NCT01773993|Secondary|Number of Participants With Adverse Drug Reactions Related to Vision-related Events|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to vision-related events was evaluated.|From Week 1 to 52 weeks|The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.|||Participants|||Number
2638455|NCT01773993|Secondary|Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to dizziness, somnolence, loss of consciousness, syncope, and potential for accidental injury was evaluated.|From Week 1 to 52 weeks|The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.|||Participants|||Number
2638456|NCT01773993|Secondary|Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to peripheral edema or other edema-related events was evaluated.|From Week 1 to 52 weeks|The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.|||Participants|||Number
2638457|NCT01773993|Secondary|Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to LYRICA Capsules was assessed by the physician.|From Week 1 to 52 weeks|The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.|||Percentage of Participants|||Number
2638458|NCT01773993|Secondary|Percentage of Participants With Serious Adverse Drug Reaction|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to LYRICA Capsules was assessed by the physician.|From Week 1 to52 weeks|The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.|||Percentage of Participants|||Number
2638459|NCT01773993|Primary|Percentage of Participants With Adverse Drug Reaction|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician.|From Week 1 to 52 weeks at maximum|The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.|||Percentage of Participants|||Number
2638460|NCT01773967|Secondary|Diarrhea Duration|diarrhea duration in hours after randomization|14 days||||hours||Inter-Quartile Range|Median
2638461|NCT01773967|Secondary|Number of Participants With LGG Bacteremia|bacteremia caused by LGG|1 month||||Participants|||Count of Participants
2638462|NCT01773967|Primary|Number of Participants With Modified Vesikari Scale Score >=9|This is a validated gastroenteritis severity score that includes duration and frequency of diarrhea, duration and frequency of vomiting, duration and frequency of fever and use of health care resources. Scores >=9 indicate moderate-severe gastroenteritis. Higher is worse.|14 days||||Participants|||Count of Participants
2638463|NCT01773954|Other Pre-specified|Change in Total Thickness at the Foveal Center Point on OCT||Baseline to Week 52||||micrometers||95% Confidence Interval|Mean
2638464|NCT01773954|Primary|Mean Change in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score||Baseline to Week 52||||letters||95% Confidence Interval|Mean
2638465|NCT01773889|Primary|Clinical Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Response = CR + PR.~Failure to respond criteria are not based on RECIST criteria, which have unclear application to immune-based clinical trials. Instead, novel lack-of-failure criteria, rather than failure-of-success criteria have been written to avoid stopping therapy prematurely without compromising patient safety, to accommodate the uncertainties of assessing failure in this setting. The criteria as written are based on sound medical, scientific and ethical principles. The trial is further designed to help establish the utility of these novel criteria."|every 3 months until the date of first documented progression or date of death from any cause, assessed up to 2 years when study terminated early||||participants|||Number
2638466|NCT01773473|Secondary|Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) at Week 26|LS means were calculated by MMRM analysis using change from baseline in 1.5-AG variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline SMBG variable value as a covariate and participants as a random effect.|Baseline, Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and Week 26 1,5-AG measurements.|||micrograms/milliliter (µg/mL)||95% Confidence Interval|Least Squares Mean
2638467|NCT01773473|Secondary|Insulin Dose at Week 26|Insulin dose is the total daily dose including basal and prandial doses.|Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had Week 26 insulin dose measurement.|||units of insulin per day (IU/day)||Standard Deviation|Mean
2638468|NCT01773473|Secondary|Number of Hypoglycemic Events Baseline Through Week 26 (Incidence)|A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a BG concentration of ≤ 70milligrams/deciliter [mg/dL (3.9 mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines [American Diabetes Association (ADA) 2005].|Baseline through Week 26|All randomized participants who received at least 1 dose of study drug.|||events|||Number
2638469|NCT01773473|Secondary|Change From Baseline in Body Weight at Week 26|LS means were calculated by MMRM analysis using change from baseline in weight variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline SMBG variable value as a covariate and participants as a random effect.|Baseline, Week 26|All randomized participants who received at least 1 dose of study drug and had baseline and Week 26 body weight measurements.|||kilogram (kg)||95% Confidence Interval|Least Squares Mean
2638470|NCT01773473|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at Week 26|LS means were calculated by MMRM analysis using change from baseline in FBG variables at all post baseline measurement as dependent variables, treatment, country, BG excursion, visit and treatment-by-visit interaction as fixed effects, baseline self-monitoring blood glucose (SMBG) variable value as a covariate and participants as a random effect.|Baseline, Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and Week 26 FBG measurement.|||millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2638471|NCT01773473|Secondary|Percentage of Participants Achieving HbA1c of <7.0% or ≤6.5% Baseline Through Week 26|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. The percentage of participants with HbA1c <7.0% or HbA1c ≤6.5% is calculated as the number of participants with an HbA1c level of the cut-off value (<7.0% or ≤6.5%) divided by the number of participants treated, then multiplied by 100.|Baseline through Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and at least 1 post-baseline HbA1c measurement.|||percentage of participants|||Number
2638472|NCT01773473|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by Mixed Models Repeated Measurements (MMRM) analysis using change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, blood glucose (BG) excursion, country, visit and treatment-by-visit interaction as fixed effects, baseline HbA1c value as a covariate and participants as a random effect.|Baseline, Week 26|All randomized participants who received at least 1 dose of study drug and analyzed according to the assigned treatment regardless of study drug dose the participant received and had baseline and Week 26 HbA1c measurements.|||percentage of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
2638473|NCT01773421|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|Safety assessments consisted of monitoring and recording all AEs and SAEs; regular monitoring of hematology, clinical chemistry, and urine values; physical examinations; and regular measurement of vital signs, ECG, and multiple-gated acquisition (MUGA) scans or echocardiograms.|From the first dose of study drug up to 30 days after the last dose of study drug (approximately up to 6.6 years)|The safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2638474|NCT01773421|Secondary|Extension Phase Part A, and Treatment and Extension Phase Part B: Number of Participants With Death and Progressive Disease (PD)|PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions. For PD: participants with best response of PD have been reported. For Death: participants with death known to have died at any point have been reported.|From first dose date to the date of the first documentation of confirmed PD or death (approximately up to 6.6 years)|The efficacy evaluable set. Due to lack of available summarized data, data has been presented only descriptively in terms of number of participants who were known to have died and number of who had PD.|||Participants|||Count of Participants
2638475|NCT01773421|Secondary|Extension Phase Part A, and Treatment and Extension Phase Part B: Duration of Response|Duration of response based on RECIST 1.1 for target and non-target lesions is the time from the date of first documented confirmed CR/PR until the first documentation of confirmed progressive disease (PD) or death, whichever came first. CR: disappearance of target and non-target lesions,normalization of tumor marker level,all lymph nodes must be non-pathological in size(<10 mm short axis). PR: at least 30% decrease in SOD of target lesions,taking as reference the baseline SOD persistence of one or more non- target lesions and/or maintenance of tumor marker level above the normal limits. PD:at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions,taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|From date of first documented confirmed CR/PR until date of first documentation of PD or death (approximately up to 6.6 years)|Duration of response was not analyzed since no participants had best overall response of CR or PR in the study.||||||
2638476|NCT01773421|Secondary|Extension Phase Part A, and Treatment and Extension Phase Part B: Number of Participants With Best Overall Response (BOR)|BOR based on RECIST 1.1 for target and non-target lesions is complete response (CR) or partial response (PR) for >4 weeks or stable disease (SD) for >5 weeks from first dose. CR: disappearance of target and non-target lesions, normalization of tumor marker level, all lymph nodes must be non- pathological in size (<10 millimeter [mm] short axis). PR: at least 30% decrease in sum of diameters (SOD) of target lesions, taking as reference the baseline SOD persistence of one or more non- target lesions and/or maintenance of tumor marker level above the normal limits. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SOD. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|From first dose of study drug (Baseline) up to approximately 6.6 years|The efficacy evaluable analysis set: all participants with a completed tumor assessment at Baseline (Chest, Abdomen and Pelvis scans) and at least 1 complete posttreatment tumor assessment (as per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1). Overall number of participants analyzed signifies participants evaluable for this measure.|||Participants|||Count of Participants
2638477|NCT01773421|Primary|Treatment Phase Part B: Maximum Tolerated Dose (MTD) of E7820 BID Dosing Schedule|MTD defined as the highest dose level at which no more than 1 of 6 participants experienced a dose-limiting toxicity(DLT), with the next higher dose having at least 2 of 3 or 2 of 6 participants experiencing DLTs. DLTs were defined using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events(CTCAE) Version 4.03 as: Neutropenia less than(<) 0.5*10^9/liter(L) for greater than(>) 5 days; neutropenia <1*10^9/L with fever; thrombocytopenia <25*10^9/L accompanied by bleeding or thrombocytopenia <10*10^9/L; any Grade 3 or 4 nonhematological toxicity for which the study drug could not be excluded as a cause (other than nausea, vomiting or diarrhea in the absence of appropriate prophylaxis) with the following clarification: Grade 3 or 4 nonhematological laboratory abnormalities for which there was no expected clinical correlation would not be considered DLTs; treatment delay of >14 days required to recover from E7820-related toxicities.|Up to Cycle 6 (Cycle length =28 days)|MTD was assessed in safety analysis set. The safety analysis set included all participants who received at least 1 dose of study drug.|||mg|||Number
2638478|NCT01773421|Primary|Treatment Phase Part A: Cmax: Maximum Observed Plasma Concentration for E7820||Day 1 or 8: 0.5-48 hours|The PK analysis set included all participants who had sufficient PK data to derive at least 1 PK parameter.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2638479|NCT01773421|Primary|Treatment Phase Part A: AUC(0-t): Area Under the Plasma Concentration- Time Curve From Time 0 to t for E7820||Day 1 or 8: 0.5-48 hours|The PK analysis set included all participants who had sufficient PK data to derive at least 1 PK parameter.|||ng*hr/mL||Standard Deviation|Mean
2638480|NCT01773421|Primary|Treatment Phase Part A: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for E7820||Day 1 or 8: 0.5-48 hours|The pharmacokinetic (PK) analysis set included all participants who had sufficient PK data to derive at least 1 PK parameter. Participants who were evaluable at a particular time point for this endpoint were included in the assessment.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
2638556|NCT01772719|Secondary|Duration of Response|Response will be accessed by one of the study investigators at each monthly follow up visit during year one.|Year 1 follow up visits occur monthly|Study Terminated, zero total participants analyzed||||||
2638481|NCT01773291|Secondary|Muscle Power (MP)|"Medical Research Council (MRC) muscle-grading scale Grade MRC grade of muscle strength 0 No movement~Flicker of movement only~Movement possible when assisted by gravity or gravity is eliminated~Movement possible against gravity but without imposed resistance~Weak movement possible against gravity~Normal movement against gravity and against imposed resistance~The 4 muscle groups were assessed on the 0 to 5 scale and scores were summed before and after treatment during hospitalization. The total score ranges from 0-20, with higher score indicating better outcome."|6 weeks|The subjects were treated 3 times a week (maximum 18 sessions in 6 weeks). The MP was measured before and after treatment during hospitalization.|||units on a scale||Standard Deviation|Mean
2638482|NCT01773291|Primary|Glasgow Coma Scale (GCS)|"Eye response (E)~There are four grades starting with the most severe:~No eye opening~Eye opening in response to pain stimulus.~Eye opening to speech.~Eyes opening spontaneously Verbal response (V)~There are five grades starting with the most severe:~No verbal response~Incomprehensible sounds.~Inappropriate words.~Confused.~Oriented. Motor response (M)~There are six grades:~No motor response~Decerebrate posturing accentuated by pain~Decorticate posturing accentuated by pain~Withdrawal from pain~Localizes to pain~Obeys commands~The sum of the score was measured (3 - 15) before and after treatment during hospitalization. The higher score, the better outcome."|6 weeks|The subjects were treated 3 times a week (maximum 18 sessions in 6 weeks). The GCS was measured before and after treatment during hospitalization.|||units on a scale||Standard Deviation|Mean
2638483|NCT01773226|Secondary|Physical Function Score|Changed Outcome Measure Description to: The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation.|Baseline, Week 1, Week 2, and at Months 1, 3, and 6.|Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint.|||Scores on a WOMAC functionality scale||Standard Deviation|Mean
2638484|NCT01773226|Secondary|Stiffness Score|Changed Outcome Measure Description to: The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation.|Baseline, Week 1, Week 2, and at Months 1, 3, and 6.|Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint.|||Scores on a WOMAC stiffness scale||Standard Deviation|Mean
2638485|NCT01773226|Secondary|Pain Score|The Western Ontario and McMaster Universities osteoarthritis index questionnaire using the Likert scale (WOMAC LK), Version 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item was to be answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). The scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. A higher score indicates worse pain, stiffness, or functional limitation.|Baseline, Week 1, Week 2, and at Months 1, 3, and 6.|Results of the WOMAC LK 3.1 questionnaire (pain, stiffness, and functionality subscores) were summarized by timepoint.|||Scores on a WOMAC pain scale||Standard Deviation|Mean
2638486|NCT01773226|Secondary|Number of Patients Using Rescue Medication|Explore the potential for an analgesic effect of a single dose of APS in patients with OA of the knee.|Up to 6 months post-injection|The incidence of patients using rescue medication for OA pain.|||Frequency of Patients using Rescue medic|||Number
2638487|NCT01773226|Primary|Number of Adverse Events|Safety and tolerability will be assessed from AEs and injection-site reactions, physical examinations, knee examinations, vital signs, ECGs, and clinical laboratory tests (hematology, coagulation, blood chemistry, and urinalysis) evaluated at baseline (pre-injection) and post-injection up to 6 months.|Up to 6 months post-injection|In cases where a patient reported multiple occurrences of an AE, the first occurrence of the worst reported case of the event was to be used for the purpose of analysis.|||Adverse Events (AEs)|||Number
2638488|NCT01773135|Primary|Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor|measurement of maternal serum ACTH in women daignosed as threatened preterm labor to evaluate if this hormone can be used as a predictive marker for preterm labor|9 weeks||||pg/ml||Inter-Quartile Range|Median
2638489|NCT01773122|Secondary|Maximum Plasma Level (Cmax) of Dapsone Metabolites|Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended. The dapsone metabolites are N-acetyl dapsone and dapsone hydroxylamine.|Day 28|All treated subjects with data for this time point|||Nanograms/Milliliter (ng/mL)||Standard Deviation|Mean
2638490|NCT01773122|Primary|Maximum Plasma Level (Cmax) of Dapsone|Cmax is the maximum plasma level following multiple doses of dapsone. Plasma is the liquid component of the blood in which the blood cells are suspended.|Day 28|All treated subjects with data for this time point|||Nanograms/Milliliter (ng/mL)||Standard Deviation|Mean
2638491|NCT01773109|Primary|Overall Objective Response Rate|The primary objective of this phase 2 trial is to estimate the objective response rate (Complete Response or Partial Response, as measured by RECIST version 1.1) for patients with metastatic or recurrent NSCLC being treated with etirinotecan pegol after failure of second-line therapy.|6 weeks||||Participants|||Count of Participants
2638492|NCT01773070|Secondary|Percentage of Participants Who Experienced Relapse˅Overall Without and With New HCV Infection|Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse˅overall was defined as a confirmed HCV RNA ≥ LLOQ between end of treatment and up to and including the last HCV RNA measurement collected in the post-treatment Period for a participant with HCV RNA < LLOQ at Final Treatment Visit who completed treatment.|Up to 3 years post-treatment|Participants with HCV RNA < LLOQ at Final Treatment Visit who completed treatment. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.|||percentage of participants|||Number
2638493|NCT01773070|Secondary|Percentage of Participants Who Experienced Relapse24 Without and With New HCV Infection|Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse24 is defined as a confirmed HCV RNA ≥ LLOQ within the sustained virologic response at Week 24 post-dosing (SVR24) window for a participant who achieved SVR12 and had HCV RNA data available in the SVR24 window.|From the end of treatment through 24 weeks post-treatment|Participants who achieved SVR12 and had HCV RNA data available in the SVR24 window. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.|||percentage of participants|||Number
2638494|NCT01773070|Secondary|Percentage of Participants Who Experienced Relapse12 Without and With New HCV Infection|Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse12 is defined as a confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA < LLOQ at Final Treatment Visit who completed treatment.|From the end of treatment through 12 weeks post-treatment|Participants with HCV RNA < LLOQ at Final Treatment Visit who completed treatment. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.|||percentage of participants|||Number
2638495|NCT01773070|Primary|Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B|The persistence of specific hepatitis C amino acid variants (treatment-emergent substitutions) associated with drug resistance in NS3, NS5A, or NS5B was evaluated in participants who had not achieved SVR12. Post-baseline time points were calculated relative to the last dose of study drug in the previous study.|from the last dose of study drug in the previous study up to 3 years post-treatment|GT1a-infected participants who experienced virologic failure after receiving ABT-450, ABT-333 or ABT-267, and had not achieved SVR12 and had post-baseline sequencing data for NS3, NS5A, or NS5B at given time point.|||Participants|||Count of Participants
2638496|NCT01773070|Primary|Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection|Relapse is defined as a confirmed HCV ribonucleic acid (RNA) ≥ the lower limit of quantitation (LLOQ) at any time during the post-treatment period for a participant who had HCV RNA < LLOQ at the end of treatment. Relapse12overall is defined as a confirmed HCV RNA ≥ LLOQ at any time after the sustained virologic response at Week 12 post-dosing (SVR12) assessment time point for a participant who achieved SVR12 and had post-SVR12 HCV RNA data available. SVR12 is defined as HCV RNA < LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. New HCV infection is defined as re-infection with a different HCV isolate.|Up to 3 years post-treatment|Participants who achieved SVR12 and had post-SVR12 HCV RNA data available. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.|||percentage of participants|||Number
2638497|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 13: No Risky Sex)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Didn't think you needed it because you weren't having risk sex?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
2638498|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 12: Ran Out of Pills)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Ran out of study pills?"|48 weeks||||Participants|||Count of Participants
2638499|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 11: Felt Depressed)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Felt depressed/overwhelmed?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
2638500|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 10: Felt Ill)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Felt sick or ill?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
2638501|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 9: Fell Asleep)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Fell asleep/slept through dose time?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
2638502|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 8: Study Pill Harmful)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Felt like the study pill was toxic/harmful?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
2638557|NCT01772719|Secondary|Overall Survival|OS(Overall survival) is measured from date of study enrollment until death.|At start of year 2 of follow-up on all surviving participants|Study was terminated and PI has left the institution. Sincere efforts were made to gather and report the data, however, no data is available for the study||||||
2638503|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 7: Routine Change)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Had a change in daily routine?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
2638504|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 6: Others Notice)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Did not want others to notice you taking meds?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
2638505|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 5: Side Effects)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Wanted to avoid side effects?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
2638506|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 4: Too Many Pills)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Had too many study pills to take?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
2638507|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 3: Simply Forgot)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Simply forgot?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
2638508|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 2: Busy With Other Things)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Were too busy with other things?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
2638509|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders as Measured by Subject Rating of the Reasons for Missing Medications on a 4-point Likert Scale. (Question 1: Away From Home)|"Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:~Were away from home?"|48 weeks|Participants enrolled at Week 48 providing a response to this question.|||Participants|||Count of Participants
2638510|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders: Number Discontinuing Text Messaging Reminders|Number of subjects who discontinued receiving text message reminders while they were still on the study agent|48 weeks|Total number of subjects signed up for text message reminders This objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®) and were eligible to receive text messages. As a result, this outcome was not assessed separately for each group.|||Participants|||Count of Participants
2638511|NCT01772823|Secondary|Acceptability and Feasibility of Text Message Reminders: Number Using Text Messaging Reminders|Total number of subjects who signed up for text message reminders|48 weeks|This objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®) and were eligible to receive text messages. As a result, this outcome was not assessed separately for each group.|||Participants|||Count of Participants
2638512|NCT01772823|Secondary|Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (High Risk Sex Acts)|"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns whether the subject reported any high risk sex acts with a male partner, defined as an answer of greater than 0 to the question Of these males (male partners), how many did you have unprotected oral or anal sex with since the last time you took this survey?"|48 weeks|Participants providing ACASI data for these questions|||Participants|||Count of Participants
2638513|NCT01772823|Secondary|Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Log 10 Viral Load)|"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns the subject's viral load, assessed here as Log 10 Viral Load (copies/ml)"|48 weeks|Enrolled subjects|||copies/ml||Standard Deviation|Mean
2638514|NCT01772823|Secondary|Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (BMI, Categorical)|"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns the subject's BMI (kg/m2), assessed categorically."|48 weeks|Enrolled subjects|||Participants|||Count of Participants
2639607|NCT01763866|Secondary|Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2638515|NCT01772823|Secondary|Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Ethnicity, Hispanic vs. Non-Hispanic or Latino)|"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns the subject's ethnicity, (Hispanic vs. Non-Hispanic or Latino)"|48 weeks|Enrolled subjects|||Participants|||Count of Participants
2638516|NCT01772823|Secondary|Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 2 Categories)|"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns the subject's race (2 categories)"|48 weeks|Enrolled subjects|||Participants|||Count of Participants
2638517|NCT01772823|Secondary|Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Race, 5 Categories)|"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns the subject's race (5 categories)"|48 weeks|Enrolled subjects|||Participants|||Count of Participants
2638518|NCT01772823|Secondary|Explore Potential Demographic and/or Behavioral Differences Between Youth Who Are Interested in Participating in a PrEP Study Versus Those Who Are Not. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared.||48 weeks|Data not collected||||||
2638519|NCT01772823|Secondary|Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared. (Age)|"Explores potential demographic and/or behavioral differences between youth who stay on PrEP compared to those who discontinue use.~PrEP status (On/Off PrEP) is determined by whether a subject prematurely discontinued from the study agent or not.~This item concerns the subject's age at enrollment."|48 weeks|Enrolled subjects|||years||Standard Deviation|Mean
2638520|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 10 of 10: I Felt Comfortable Participating in This Workshop/Session."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 10 of 10: I felt comfortable participating in this workshop/session."|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
2638521|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 9 of 10: I Would Recommend This Workshop/Session to Others."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 9 of 10: I would recommend this workshop/session to others."|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
2638522|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 8 of 10: The Workshop/Session Was Enjoyable."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 8 of 10: The workshop/session was enjoyable."|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
2638523|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 7 of 10: The Topic of This Workshop/Session Was Relevant to my Life."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 7 of 10: The topic of this workshop/session was relevant to my life"|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
2638524|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 6 of 10: The Presenter(s) Stimulated my Interest in the Material."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 6 of 10: The presenter(s) stimulated my interest in the material"|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
2638525|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 5 of 10: The Topic of This Workshop/Session Was Interesting."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 5 of 10: The topic of this workshop/session was interesting"|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
2638558|NCT01772719|Primary|Change in Paraprotein Level and Free Light Chain (FLC) Ratio From Baseline Measurement|The effect of simvastatin and zolendronic acid on M-Protein and FLC ratio will be measured 4 weeks after treatment begins, then every 4 weeks until progression of disease.|4 weeks after treatment begins|NA = Not available, Study was terminated and PI has left the institution. Sincere efforts were made to gather and report the data, however, no data is available for the study||||||
2638526|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 4 of 10: The Workshop/Session Was Well Organized."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 4 of 10: The workshop/session was well organized"|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
2638527|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 3 of 10: I Was Given an Opportunity to Participate and Discuss Information With Others."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 3 of 10: I was given an opportunity to participate and discuss information with others"|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
2638528|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 2 of 10: I Will be Able to Apply What I Learned From This Workshop/Session in my Life."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 2 of 10: I will be able to apply what I learned from this workshop/session in my life"|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
2638529|NCT01772823|Secondary|"Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation. Item 1 of 10: I Learned a Lot From This Workshop/Session."|"Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was the session interesting, was it relevant to their life, did they learn from the session).~Item 1 of 10: I learned a lot from this workshop/session"|48 weeks|Participants providing a response to this question on the Session Evaluation Form|||Participants|||Count of Participants
2638530|NCT01772823|Primary|Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)|"This outcome addresses the objective: Measured Levels of Drug Exposure (DBS RBC TFV-DP) When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP concentrations."|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Enrolled subjects (Individual row Ns vary due to the number of subjects per week enrolled at that time point and with DBS data) This primary objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.|||fmol/punch||Standard Deviation|Mean
2638531|NCT01772823|Primary|Measured Levels of Drug Exposure (DBS RBC FTC-TP) When YMSM Are Provided Open Label FTC/TDF (Truvada®)|PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular FTC-triphosphate concentrations.|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Enrolled subjects (Individual row Ns vary due to the number of subjects per week enrolled at that time point and with DBS data) This primary objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.|||pmol/punch||Standard Deviation|Mean
2638532|NCT01772823|Primary|Patterns of Use, Rates of Adherence and Measured Levels of Open Label FTC/TDF (Truvada®) Drug Exposure|"This outcome addresses the objective: Patterns of Use, Rates of Adherence and Measured Levels of Drug Exposure When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~PrEP medication levels were assessed via dried blood spot (DBS) collected at each visit to quantify intracellular TFV-DP and FTC-triphosphate concentrations. DBS results were translated into dosing categories previously used in PrEP trials with adult MSM. Dosing categories included below lower limit of quantitation (BLQ), lower limit of quantitation to 349 fmol per punch (fewer than 2 tablets per week), 350- 699 fmol per punch (2-3 tablets per week), 700-1250 fmol per punch (4 tablets per week), and >1250 fmol per punch (daily)."|Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Enrolled subjects (Individual row Ns vary due to the number of subjects per week enrolled at that time point and with DBS data) This primary objective did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group.|||Participants|||Count of Participants
2638533|NCT01772823|Primary|Acceptability of PrEP: Distribution of Participant Feelings About Physician Exam|"This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having a physician exam by a doctor"|Week 12|Participants enrolled at Week 12 who provided a response to this question.|||Participants|||Count of Participants
2638534|NCT01772823|Primary|Acceptability of PrEP: Distribution of Participant Feelings About Questions About Sexual Behavior|"This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about being asked questions about sexual behavior at every visit"|Week 12|Participants enrolled at Week 12 who provided a response to this question.|||Participants|||Count of Participants
2638535|NCT01772823|Primary|Acceptability of PrEP: Distribution of Participant Feelings About Risk Reduction Counseling at Every Visit|"This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having individual risk reduction counseling at every visit"|Week 12|Participants enrolled at Week 12 who provided a response to this question.|||Participants|||Count of Participants
2638536|NCT01772823|Primary|Acceptability of PrEP: Distribution of Participant Feelings About HIV Test at Every Visit|"This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about having an HIV test at every visit."|Week 12|Participants enrolled at Week 12 who provided a response to this question.|||Participants|||Count of Participants
2638537|NCT01772823|Primary|Acceptability of PrEP: Distribution of Participant Feelings About Taking Part in the Study|"This outcome addresses the objective Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies.~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.~This specific outcome focuses on the question of how participants felt about taking part in the study."|Week 12|Participants enrolled at Week 12 who provided a response to this question.|||Participants|||Count of Participants
2638538|NCT01772823|Primary|Acceptability of PrEP: Distribution of Participant Feelings About Taking the Pill Every Day|"This outcome addresses the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies.~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.~This specific outcome focuses on the question of how participants felt about taking the pill every day."|Week 12|Participants enrolled at Week 12 who provided a response to this question.|||Participants|||Count of Participants
2638539|NCT01772823|Primary|Acceptability of PrEP: Distribution of Participant Feelings About Color of the Pill|"This outcome addresses the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.~This specific outcome focuses on the question of how participants felt about the color of the pill."|Week 12|Participants enrolled at Week 12 who provided a response to this question.|||Participants|||Count of Participants
2638540|NCT01772823|Primary|Acceptability of PrEP: Distribution of Participant Feelings About Taste of the Pill|"This outcome addresses the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions.~This specific outcome focuses on the question of how participants felt about the taste of the pill."|Week 12|Participants enrolled at Week 12 who provided a response to this question.|||Participants|||Count of Participants
2638541|NCT01772823|Primary|Acceptability of PrEP: Distribution of Participant Feelings About Size of the Pill|"This outcome addresses the objective: Acceptability When YMSM Are Provided Open Label FTC/TDF (Truvada®) and Information Regarding the Safety and Efficacy of PrEP From Prior Studies.~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions. This question reports on how the participants felt about the size of the pill."|Week 12|Participants enrolled at Week 12 who provided a response to this question.|||Participants|||Count of Participants
2638542|NCT01772823|Primary|Number of Sex Partners|"This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM, specifically behavioral disinhibition/risk compensation endpoints.~Responses to the participant ACASI question referring to number of male partners in the past month/since the last survey:~During the past month, how many male partners have you had sexual contact with (oral or anal)? (Baseline), or Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)? (Week 48)~And responses to the participant ACASI question referring to number of HIV-positive male partners in the past month/since the last survey:~Of those you had unprotected sex with, how many did you know were HIV positive?"|Baseline and 48 weeks|"Participants at Baseline/Week 48 providing a response to this question. The primary objective Additional safety data regarding FTC/TDF (Truvada®) use did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group."|||sexual partners||Standard Deviation|Mean
2638559|NCT01772654|Primary|Intensity of the MRI Signal in the Left Temporal Precentral Zone|Subjects who were already scheduled to have a Magnetic Resonance Imaging (MRI) procedure as part of an evaluation for epilepsy had an additional sequence added during the MRI. The additional MRI sequence was called Arterial Spin Labeling (ASL), and consisted of 4 minutes additional time in the MRI scanner. The ASL sequence did not use any contrast or radiation. The ASL sequence is a blood flow measure, and compared the intensity of the MRI signal in patients with left temporal lobe epilepsy to the intensity of the MRI signal in patients with normal brains. Intensity of MRI signal is measured on the MRI image slices in different anatomic regions as an optical density (dark to bright). It is then referenced to a region of the brain that is considered stable standard as a ratio.|Approximately in the middle of the MRI procedure||||ratio||Standard Deviation|Mean
2638543|NCT01772823|Primary|Number of Participants With Unprotected Sex Acts|"This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM, specifically behavioral disinhibition/risk compensation endpoints.~Responses to the participant ACASI question referring to male partners in the past month/since the last survey:~Of these males (male partners), how many did you have unprotected oral or anal sex with in the last month? (Baseline), or Of these males (male partners), how many did you have unprotected oral or anal sex with since the last time you took this survey? (Week 48) An event is defined as an answer of greater than 0."|Baseline and 48 weeks|"Participants at Baseline/Week 48 providing a response to this question. The primary objective Additional safety data regarding FTC/TDF (Truvada®) use did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group."|||Participants|||Count of Participants
2638544|NCT01772823|Primary|Total Hip Bone Mineral Density at Baseline and at Week 48|"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for total hip."|Baseline, Week 48|"Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective Additional safety data regarding FTC/TDF (Truvada®) use does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group."|||g/cm2||Standard Deviation|Mean
2638545|NCT01772823|Primary|Total Body Bone Mineral Density at Baseline and at Week 48|"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for total body."|Baseline, Week 48|"Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective Additional safety data regarding FTC/TDF (Truvada®) use does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group."|||g/cm2||Standard Deviation|Mean
2638546|NCT01772823|Primary|Femoral Neck Bone Mineral Density at Baseline and at Week 48|"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for femoral neck."|Baseline, Week 48|"Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective Additional safety data regarding FTC/TDF (Truvada®) use does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group."|||g/cm2||Standard Deviation|Mean
2638547|NCT01772823|Primary|Lumbar Spine Bone Mineral Density at Baseline and at Week 48|"This outcome addresses the objective: Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~Bone mineral density at Baseline and Week 48: data reported below for lumbar spine."|Baseline, Week 48|"Participants with DXA results. (Baseline N=197, Week 48 N=135). The primary objective Additional safety data regarding FTC/TDF (Truvada®) use does not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group."|||g/cm2||Standard Deviation|Mean
2638548|NCT01772823|Primary|Number of Participants With Decrease in Absolute Bone Mineral Density (BMD) From Baseline to Week 48|"This outcome addresses the objective Additional Safety Data Regarding FTC/TDF (Truvada®) Use Among HIV-uninfected YMSM.~The total number of participants with dual-energy radiography absorptiometry scanning (DXA) data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body) between Baseline and Week 48."|48 weeks|"Enrolled subjects with DXA results for Baseline and Week 48 The primary objective Additional safety data regarding FTC/TDF (Truvada®) use did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group."|||Participants|||Count of Participants
2638549|NCT01772823|Primary|Number of Participants With Serum Creatinine Event of Grade 1 or Higher|"This measure addresses the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM~Serum creatinine was tested at every study visit (Baseline through Week 48). The number of participants with a serum creatinine laboratory toxicity of Grade 1 or higher was assessed. Grade 1 (Mild) toxicity was defined as: 1.1 - 1.3 x ULN, where ULN is the Upper limit of normal."|48 Weeks|"Participants with visit data through 48 weeks. The primary objective Additional safety data regarding FTC/TDF (Truvada®) use did not involve comparison of the behavioral intervention groups. All participants in both groups received FTC/TDF (Truvada®). As a result, this outcome was not assessed separately for each group."|||Participants|||Count of Participants
2638550|NCT01772758|Primary|Percentage Flow-Mediated Dilation (FMD)|Brachial artery FMD induced by reactive hyperemia assessed vascular endothelial function at baseline and several hours after treatment.|pre-treatment Baseline and 2-3 hours post-treatment|Participants included patients diagnosed with cystic fibrosis and healthy age-matched controls.|||percentage of change in FMD||Standard Deviation|Mean
2638551|NCT01772719|Secondary|Comparison of Quality of Life Scores|The QOL scores taken at the start of the study and every 4 months after treatment starts will be analyzed using Wilcoxon test for paired differences|Up to 2 months after last treatment has been completed|Study was terminated and PI has left the institution. Sincere efforts were made to gather and report the data, however, no data is available for the study||||||
2638552|NCT01772719|Secondary|Incidence Rate of Toxicity|Descriptive statistics will be provided regarding incidence rates of toxicity. Patients will be monitored for safety throughout the study.|Every 12 months up to one month after treatment completion|Study was terminated and PI has left the institution. Sincere efforts were made to gather and report the data, however, no data is available for the study||||||
2638553|NCT01772719|Secondary|Duration of Response|Response will be assessed by one of the study investigators at each six month follow up visit for Year 3-5|Year 3-5 follow up visit occurs every six months|Study was terminated and PI has left the institution. Sincere efforts were made to gather and report the data, however, no data is available for the study||||||
2638554|NCT01772719|Secondary|Duration of Response|Response will be assessed by one of the study investigators at each three month follow up visit for Year 2|Year 2 follow up visit occur every three months|Study was terminated and PI has left the institution. Sincere efforts were made to gather and report the data, however, no data is available for the study||||||
2638564|NCT01772576|Secondary|Complication Free Rate|Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.|3 months through 15 months post implant|156 patients remained after 3 months in the study without lead related complication. Those were used for the secondary endpoint.|||percentage of total participants||95% Confidence Interval|Number
2638565|NCT01772576|Primary|Complication Free Rate|Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.|3-months follow-up|Patients enrolled in the study and having received the RELIANCE 4FRONT active fixation lead|||percentage of all subjects||95% Confidence Interval|Number
2638566|NCT01772550|Secondary|Catheter Integrity Failure|"Catheter integrity failure generally refers to any portion of the device breaking or malfunctioning so that its proper function is no longer assured. In this study, the most relevant catheter integrity failures to be assessed were fluid leakage, tubing rupture, or tubing separation from the hub.~The number of subjects who experienced injections with a catheter integrity failure during injection is reported. The information about the IV catheter was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection."|immediately after power injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.|||participants|||Number
2638567|NCT01772550|Secondary|Catheter Transfixation|The number of subjects who experienced catheter transfixation (the IV penetrating the opposite wall of the vein) is reported. This information was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection.|immediately after power injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.|||participants|||Number
2638568|NCT01772550|Secondary|Catheter Dislodgement|The number of subjects who experienced partial or complete dislodgement of the catheter from the subject prior to power injection procedure completion is reported. The information about the IV catheter was collected by a clinically qualified study staff member (e.g., the Principal or sub-Investigator, or Study Coordinator) after the power injection.|Immediately following power injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.|||participants|||Number
2638569|NCT01772550|Secondary|High Pressure Alarm|The number of subjects who experienced injections with activation of the high pressure alarm is reported. Immediately following the power injection, the clinician performing the power injection recorded whether or not the high pressure alarm sounded.|immediately after contrast injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.|||participants|||Number
2638570|NCT01772550|Secondary|Automatic Injection Shutoff|The number of subjects who experienced injections with automatic injection shutoff is reported. Immediately after the power injection, the injection technician recorded whether or not an automatic injection shutoff occurred.|immediately after contrast injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.|||participants|||Number
2638571|NCT01772550|Secondary|Extravasation of Contrast Media|The number of subjects who experienced injections with extravasation of contrast media is reported.|upon contrast injection|One subject randomized to the 18 GA IV was excluded from the per-protocol analysis as minimum flow rate could not be achieved. Non-randomized group analysis includes 1 subject with media extravasation with first study IV (adverse event). Subject was discontinued and not included in primary outcomes analysis.|||participants|||Number
2638572|NCT01772550|Secondary|Catheter Insertion Success|"Insertion is successful when the catheter can be flushed or infused to demonstrate patency, and there is no inadvertent administration of a solution or medication into the tissue surrounding the IV catheter.~The number of participants with successfully inserted catheters after the first or second insertion attempt is reported. The clinician inserting the IV catheter made a clinical judgement as to whether the catheter was successfully placed; the protocol did not define more specific criteria. Catheter insertion success rates were determined from each IV insertion attempted in the Study."|immediately after catheter insertion|All subjects for whom an insertion was attempted are included in the analysis for insertion success. This includes some subjects that did not go on to complete the study.|||participants|||Number
2638573|NCT01772550|Secondary|Maximum Flow Rate|Maximum flow rate guidelines provided in the BD Nexiva Diffusics Instructions for Use were to be followed. The maximum flow rate (milliliters per second, or mL/sec) utilized was recorded by the Radiology Technician immediately following the power injection of iodinated intravenous contrast media. Results are descriptively summarized; no formal acceptance criteria were specified by the protocol.|immediately after power injection|One subject randomized to the 18 GA conventional IV was excluded from the analysis as the required minimum flow rate could not be achieved due to IV placement. Non-randomized flow rate analysis only includes subjects who completed successful contrast delivery; one subject with extravasation upon delivery was discontinued and is not included.|||mL/second||Standard Deviation|Mean
2638602|NCT01772316|Secondary|Percentage of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs)/Corticosteroid Dose Reductions and/or Discontinuation||Randomization of first participant to clinical cutoff date (19MAY2015) (approximately 29 months)|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.|||percentage of participants|||Number
2639608|NCT01763866|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2638574|NCT01772550|Secondary|Complete Chest and Abdomen CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Subjects Whose Veins Could Accommodate an 18 GA IV Catheter (Randomized Subjects)|Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified.|at the time of image assessment|54 subjects had HU measurements available from complete chest and abdomen CT imaging.|||Hounsfield Units||Standard Deviation|Mean
2638575|NCT01772550|Secondary|Chest CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Subjects Whose Veins Could Accommodate an 18 GA IV Catheter (Randomized Subjects)|Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified.|at the time of image assessment|20 subjects had HU measurements available from thoracic CT imaging.|||Hounsfield Units||Standard Deviation|Mean
2638576|NCT01772550|Secondary|Abdomen CT - Average Hounsfield Units as a Measure of Aortic Contrast Delivery and Enhancement in Randomized Subjects|Objective image quality assessment was performed by a board-certified Research Radiologist, by measuring the post-contrast aortic attenuation in Hounsfield Units (HU) at either the aortic arch if chest is imaged or the diaphragmatic crus and above the aortic bifurcation or on the most inferior image on the arterial phase. Hounsfield units within the proximal and distal aorta were recorded for each subject image reviewed. The average number of HU for each group in the Study are reported descriptively; formal acceptance criteria for this objective are not specified.|at the time of image assessment|126 subjects had HU measurements available from abdominal CT imaging.|||Hounsfield Units||Standard Deviation|Mean
2638577|NCT01772550|Primary|Acceptable Image Quality|"Study images were assessed by a US board-certified radiologist to determine whether the image is of acceptable quality. The radiologist was not informed of the study device used for the injection that produced the image under evaluation. Subjective image quality assessment for acceptability was determined by:~The report of the reading radiologist in the section of the report where the radiologist indicates if the image is acceptable or not. The absence of a comment in this section will be interpreted as acceptable, and,~the assessment of an independent single second reader (such as the subinvestigator or research radiologist) blinded to the reading radiologist's report and the infusion catheter type.~In the case of a non-concurrence, the Principal Investigator assessed the image and his or her assessment had final authority."|at the time of image assessment|One subject randomized to the 18 GA conventional catheter was excluded from the per-protocol analysis. Due to catheter placement, the required minimum flow rate of 5 mL/sec could not be achieved; contrast was administered at 4.5 mL/sec.|||percentage of participants|||Number
2638578|NCT01772537|Other Pre-specified|Serum Inflammatory Markers|Serum inflammatory markers will be compared per anesthetic group, Propofol versus Isoflurane. A sample of 10 individuals from each group will have biomarkers measured|From the start of the surgery to 24 hours post-op|No data is available for serum inflammatory markers. The study did not have adequate funding to appropriately measure these variables.||||||
2638579|NCT01772537|Secondary|Number of Participants With Delirium as Assessed by the Confusion Assessment Method (CAM)|Delirium was measured using the Confusion Assessment Method and the Confusion Assessment Method- Intensive Care Unit (CAM-ICU) based upon post-operative location of patient. The patients were divided into to two groups, patients that had an open thoracoabdominal aneurysm repair versus patients that had stenting of their aneurysms. Patients that had stenting of their aneurysms were also randomized to receive either Propofol or Isoflurane as for their anesthetic.|Immediately after surgery and at 3 and 12 months post-op|Of the 6 patients that received an open thoracoabdominal aneurysm repair 2 were found to have delirium. Of the 5 subjects that had stenting and received Propofol as their primary anesthetic, 0 were found to have delirium. Of the 3 stenting subjects that received Isoflurane as their primary anesthetic, 1 were found to have delirium.|||participants|||Number
2638580|NCT01772537|Primary|Changes in CSF Levels of Amyloid|Quantitative levels of amyloid will be measured using ELISA assay technique in pg/ml to compare the differences between the group receiving Propofol and the groups receiving Isoflurane.|From insertion of spinal drain until removal|The data for changes in CSF levels of amyloid are not available. The study did not have adequate funding to appropriately measure these variables.||||||
2638581|NCT01772537|Primary|Changes in Cerebrospinal Fluid (CSF) Levels of Tau|"Quantitative levels of tau will be measured using ELISA assay technique in pg/ml to compare the differences between the group receiving Propofol and the groups receiving Isoflurane.~."|From insertion of spinal drain until removal|The data for changes in CSF levels of tau are not available. The study did not have adequate funding to appropriately measure these variables.||||||
2638582|NCT01772472|Secondary|Serum Concentrations (AUC) of Trastuzumab|Serum blood samples were collected for trastuzumab measurement prior to dosing and 15-30 minutes post infusion for Cycle 1 and Cycle 4. Additional serum samples were collected at study treatment termination.|C1D1 and C4D1 of post-infusion and study treatment termination||2023-04-30|04/2023||||
2638583|NCT01772472|Secondary|Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine (Including Total Trastuzumab and DM1)|Blood and serum samples for measurement of trastuzumab emtansine, total trastuzumab, and DM1 will be obtained from patients randomized to the trastuzumab emtansine arm.|Cycle (C) 1, Day (D) 1 and C4D1 of pre-infusion, C1D1 and C4D1 post-infusion, C2D1 and C5D1 pre-infusion and study treatment termination||2023-04-30|04/2023||||
2638603|NCT01772316|Secondary|Percentage of Participants With Remission (DAS28 <2.6 or SDAI </=3.3) at Weeks 48 and 96||Week 48, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.|||percentage of participants|||Number
2639609|NCT01763866|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2638584|NCT01772472|Secondary|Change From Baseline of Four Functioning Scales and Four Symptom Scales in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Breast Cancer (QLQ-BR23)|EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated deterioration in quality of life (QOL) and negative change from baseline indicated an improvement in QOL. For symptom scales, positive change from baseline indicated an improvement in quality of life (QOL) and negative change from baseline indicated a deterioration in QOL.|Baseline, Cycle 5, 11, Follow-up Month 6, Follow-up Month 12|Randomized Patient Population of patients with both a baseline assessment and at least one post-baseline assessment are included in the analysis.|||Units on a Scale||Standard Deviation|Mean
2638585|NCT01772472|Secondary|Change From Baseline of Functional Scales, Symptom Scales and Single Items in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)|The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1).|Baseline, Cycle 5, 11, Follow-up (FU) Month 6, Follow-up Month 12|Randomized Patient Population of patients with both a baseline assessment and at least one post-baseline assessment are included in the analysis.|||Units on a Scale||Standard Deviation|Mean
2638586|NCT01772472|Secondary|Percentage of Participants With Cardiac Dysfunction|Cardiac events were reported based on the NCI-CTCAE, v4.0.|From baseline up to 10 years||2023-04-30|04/2023||||
2638587|NCT01772472|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs, including AEs of Special Interest and AEs of Particular Interest, were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).|From Day 1 to 30 days after last dose of study drug, up to the clinical cutoff date (approximately 64 months)|The safety population was defined as all participants who have received at least one dose of study medication.|||Percentage of Participants|||Number
2638588|NCT01772472|Secondary|Distant Recurrence-Free Interval (DRFI)|DRFI was defined as the time between randomization and the date of distant breast cancer recurrence. 3 years DRFI event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after treatment.|Baseline up to 10 years||2023-04-30|04/2023||||
2638589|NCT01772472|Secondary|Overall Survival (OS)|Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. 5 years OS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 5 years after treatment.|Baseline up to 10 years||2023-04-30|04/2023||||
2638590|NCT01772472|Secondary|Disease-free Survival|Disease-free survival was defined as the time between randomization and the date of the first occurrence of an invasive disease-free survival event including second primary non-breast cancer event or contralateral or ipsilateral DCIS. 3-year DFS event-free rates per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.|From baseline up to 10 years||2023-04-30|04/2023||||
2638591|NCT01772472|Secondary|Invasive Disease-free Survival Including Second Primary Non-breast Cancer|IDFS including second primary non-breast cancer was defined the same way as IDFS for the primary endpoint but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ (CIS) of any site). 3-year IDFS including second primary non-breast cancer event-free rates per treatment arm in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.|From baseline up to 10 years||2023-04-30|04/2023||||
2638592|NCT01772472|Primary|Invasive Disease-free Survival (IDFS)|IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. 3-year IDFS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization.|From randomization to data cut-off date of 25 July 2018 (approximately up to 64 months)|The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment.|||Percent Probability||95% Confidence Interval|Number
2638979|NCT01769196|Primary|PFS Among the Participants With sLOXL2 ≥ 50th Percentile||Up to 148 weeks|Participants in the ITT Analysis Set with serum LOXL2 (sLOXL2) ≥ 50th percentile in peripheral blood were analyzed.|||months||95% Confidence Interval|Median
2638593|NCT01772368|Secondary|Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period|"TEAEs were recorded during each double-blind treatment. In addition, at the end of each treatment, patients continued to use 2 inhalations of Fp MDPI 50 mcg (100 mcg total dose) twice daily, so adverse events during this treatment were assigned to Fp MDPI 50 mcg.~An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical in"|Day 1 up to Day 35|Safety population|||Participants|||Count of Participants
2638594|NCT01772368|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Salmeterol|Blood samples for measurement of plasma SAL concentrations were obtained during each treatment visit (subjects 18 years of age and older only) and pharmacokinetic parameters were derived.|Predose (0), and at 5, 10, 15 and 30 minutes, 1, 1.5, 2, 3, 4, 8, and 12 hours postdose|Pharmacokinetic Analysis set. PK parameters for Salmeterol were not run for Fp MDPI experience.|||hours||Full Range|Median
2638595|NCT01772368|Secondary|Maximum Observed Plasma Concentration (Cmax) of Salmeterol|Blood samples for measurement of plasma SAL concentrations were obtained during each treatment visit (subjects 18 years of age and older only) and pharmacokinetic parameters were derived. The primary pharmacokinetic parameters were AUC0-t and Cmax for Salmeterol.|Predose (0), and at 5, 10, 15 and 30 minutes, 1, 1.5, 2, 3, 4, 8, and 12 hours postdose|Pharmacokinetic Analysis set. PK parameters for Salmeterol were not run for Fp MDPI experience.|||pg/mL||Standard Deviation|Mean
2638596|NCT01772368|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t) of Salmeterol|Blood samples for measurement of plasma SAL concentrations were obtained during each treatment visit (subjects 18 years of age and older only) and pharmacokinetic parameters were derived. The primary pharmacokinetic parameters were AUC0-t and Cmax for Salmeterol.|Predose (0), and at 5, 10, 15 and 30 minutes, 1, 1.5, 2, 3, 4, 8, and 12 hours postdose|Pharmacokinetic Analysis set. PK parameters for Salmeterol were not run for Fp MDPI experience.|||pg*hr/mL||Standard Deviation|Mean
2638597|NCT01772368|Secondary|Change From Baseline at 12 Hours Post-Dose in Forced Expiratory Volume in One Second (FEV1) By Treatment|"The secondary efficacy variable was the change from period-specific baseline in FEV1 at 12 hours, calculated as FEV1 measured at 12 hours postdose after subtracting period-specific baseline FEV1 at each treatment period.~The period-specific baseline FEV1 was measured at predose within 5 minutes of AM dose administration at each treatment visit. If that value was missing, then FEV1 measured at 30 minutes predose was used as the period-specific baseline."|Pre-dose: 30 minutes prior, within 5 minutes of dose. Post-dose: 12 hours|The full analysis set (FAS) included all subjects in the ITT population who received at least 1 dose of study drug and had at least 1 evaluable standardized baseline-adjusted FEV1 AUC0-12.|||mL||Standard Error|Least Squares Mean
2638598|NCT01772368|Primary|Standardized Baseline-Adjusted Area Under the Curve For Forced Expiratory Volume In 1 Second Over 12 Hours Post-dose (FEV1 AUC0-12)|Standardized baseline-adjusted FEV1 AUC0-12 was defined as the area under the curve for baseline-adjusted FEV1 measurements from the predose to 12 hours postdose time points using the trapezoidal rule based on actual (not scheduled) time of measurement and was standardized by dividing the actual time of last non-missing FEV1 measurement. Baseline-adjusted FEV1 was calculated as postdose FEV1 after subtracting period-specific baseline FEV1. The period-specific baseline FEV1 was measured at predose within 5 minutes of AM dose administration at each treatment visit. If that value was missing, then FEV1 measured at 30 minutes predose was used as the period-specific baseline.|Pre-dose: 30 minutes prior, within 5 minutes of dose. Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours|The full analysis set (FAS) included all subjects in the ITT population who received at least 1 dose of study drug and had at least 1 evaluable standardized baseline-adjusted FEV1 AUC0-12.|||mL||Standard Error|Least Squares Mean
2638599|NCT01772316|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Specified Time Points|The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Minimum score was 0, maximum score was 3. A smaller score indicated improvement.|Baseline, Week 48, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Here, 'n' represents the number of participants with a measure at the specified time point.|||units on a scale||Standard Deviation|Mean
2638600|NCT01772316|Secondary|Patient Pain VAS Score at Specified Time Points|"This assessment represents the patient's assessment of his/her current level of pain on a 100 mm horizontal VAS. The extreme left end of the line should be described as no pain and the extreme right end as unbearable pain. Scores ranged from 0 to 100 with a higher score indicating more pain. A negative change score indicated less pain."|Baseline, Week 48, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Here, 'n' represents the number of participants with a measure at the specified time point.|||units on a scale||Standard Deviation|Mean
2638601|NCT01772316|Secondary|Patient Global Visual Analog Score (VAS) at Specified Time Points|"This assessment represents the patient's overall assessment of their current disease activity on a 100 millimeter (mm) horizontal VAS. The extreme left end of the line should be described as no disease activity (symptom free and no arthritis symptoms) and the extreme right end as maximum disease activity (maximum arthritis disease activity). Scores ranged from 0 to 100 with a higher score indicating more disease activity. A negative change score indicated less disease activity."|Baseline, Week 48, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Here, 'n' represents the number of participants with a measure at the specified time point.|||units on a scale||Standard Deviation|Mean
2638918|NCT01769352|Secondary|Mean Change in Best-Corrected Visual Acuity Between Week 12 and Week 48|Mean Change in Best-Corrected Visual Acuity (Letters Score) between Week 12 and Week 48. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision.|Week 12 and Week 48||||Letters||Standard Error|Mean
2638604|NCT01772316|Primary|Change From Baseline in SJC at Week 96|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. Change in SJC = SJC at Week 96 - SJC at Baseline. A negative number indicated improvement.|Baseline, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.|||units on a scale||Standard Deviation|Mean
2638605|NCT01772316|Primary|Change From Baseline in Swollen Joint Count (SJC) at Week 48|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. A negative number indicated improvement.|Baseline, Week 48|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.|||units on a scale||Standard Deviation|Mean
2638606|NCT01772316|Primary|Change From Baseline in Total TJC at Week 96|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. A smaller number indicated improvement.|Baseline, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
2638607|NCT01772316|Primary|Change From Baseline in Total Tender Joint Count (TJC) at Week 48|An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. A smaller number indicated improvement. Here, 'n' represents the number of participants with a measure at specified time point.|Baseline, Week 48|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
2638608|NCT01772316|Primary|Change From Baseline in SDAI at Week 96|The SDAI was the numerical sum of five outcome parameter: SJC and TJC, PGA and IGA, and level of hsCRP. The index was calculated using the following formula SDAI = TJC28 + SJC28 + PGA + IGA + CRP. Change in SDAI = SDAI at Week 96 - SDAI at Baseline. SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Baseline, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
2638609|NCT01772316|Primary|Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 48|The SDAI was the numerical sum of five outcome parameter: SJC and TJC, Patient Global Assessment of Disease Activity (PGA) and Investigator Global Assessment of Disease Activity (IGA), and level of hsCRP. The index was calculated using the following formula SDAI = TJC28 + SJC28 + PGA + IGA + CRP. Change in SDAI = SDAI at Week 48 - SDAI at Baseline. SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity. Here, n signifies the number of subjects evaluable at the specified time points.|Baseline, Week 48|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
2638610|NCT01772316|Primary|Change From Baseline in DAS28-ESR at Week 96|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis. The index included SJC, TJC, acute phase response (ESR or high sensitivity C-reactive protein [hsCRP]) and general health status. For this study, ESR was used to calculate DAS28 score. The index was calculated using the following formula: DAS28 = (0.56 × √[TJC28]) + (0.28 × √[SJC28]) + (0.7 × ln[ESR]) + (0.014 × GH). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Change in DAS28ESR=DAS28-ESR at Week 96 - DAS28-ESR at Baseline.|Baseline, Week 96|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
2638611|NCT01772316|Primary|Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) at Week 48|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis. The index included swollen joint count (SJC), tender joint count (TJC), acute phase response (ESR or high sensitivity C-reactive protein [hsCRP]) and general health status (GH). For this study, ESR was used to calculate DAS28 score. The index was calculated using the following formula: DAS28 = (0.56 × √[TJC 28]) + (0.28 × √[SJC 28]) + (0.7 × ln[ESR]) + (0.014 × GH). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Change in DAS28ESR=DAS28-ESR at Week 48 - DAS28-ESR at Baseline.|Baseline, Week 48|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
2638612|NCT01772316|Primary|Percentage of Participants Withdrawn From the Study Due to Lack of Therapeutic Response||Baseline up to follow-up (Week 104)|Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.|||percentage of participants|||Number
2638613|NCT01772316|Primary|Percentage of Participants With an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a clinical investigation participant that was administered study drug, regardless of causal attribution.|Baseline up to follow-up (Week 104)|All participants receiving study drug were included in the safety analysis set.|||percentage of participants|||Number
2638919|NCT01769352|Secondary|Mean Change in Intraocular Pressure at Week 12 From Baseline|Mean Change in Intraocular Pressure (IOP) at week 12 from Baseline|Baseline and Week 12||||mmHg||Standard Error|Mean
2638614|NCT01772147|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Albuterol/Salbutamol Over Weeks 1-12|The mean number of puffs per day of rescue albuterol/salbutamol at Baseline and on-treatment was recorded. The total puffs of rescue albuterol/salbutamol for each day was calculated as: (number of puffs + [2 * number of nebules]). Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, Baseline (mean during the 4 weeks prior to Day 1), and smoking status.|Baseline and Weeks1- 12|ITT Population. Only those participants available at the indicated time point were analyzed.|||puffs||Standard Error|Least Squares Mean
2638615|NCT01772147|Secondary|Change From Baseline in the Mean Percentage of Rescue-free Days Over Weeks 1-12|A rescue-free day is defined as a day on which no rescue medication was taken. Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value minus the Baseline value.|Baseline and Weeks 1- 12|ITT Population. Only those participants available at the indicated time point were analyzed.|||Percentage of days||Standard Deviation|Mean
2638616|NCT01772147|Secondary|Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. The weighted mean was calculated using the 6-hour serial FEV1 measurements at Day 84, which included pre-dose, and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 84 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline, and day by treatment interactions.|Baseline and Day 84|ITT Population. Only those participants available at the indicated time point were analyzed.|||Liters||Standard Error|Least Squares Mean
2638617|NCT01772147|Primary|Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Treatment Day 84 (i.e., at Week 12). Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 minutes (min) pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 85 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline, and day by treatment interactions.|Baseline and Day 85|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the Treatment Period. Only those participants available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2638618|NCT01772134|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Albuterol/Salbutamol Over Weeks 1-12|The mean number of puffs per day of rescue albuterol/salbutamol at Baseline and on-treatment was recorded. The total puffs of rescue albuterol/salbutamol for each day was calculated as: (number of puffs + [2 * number of nebules]). Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value value minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of treatment, Baseline (mean during the 4 weeks prior to Day 1), and smoking status.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time point were analyzed.|||puffs||Standard Error|Least Squares Mean
2638619|NCT01772134|Secondary|Change From Baseline in the Mean Percentage of Rescue-free Days Over Weeks 1-12|A rescue-free day is defined as a day on which no rescue medication was taken. Baseline calculations include a period of the later of 27 days before Visit 2 and the day after Visit 1, up to and including Day 1. The Weeks 1-12 calculations include a period from Study Day 2 up to the earlier of Study Day 85 and the day before Visit 7. Change from Baseline was calculated as the Weeks 1-12 value minus the Baseline value.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the indicated time point were analyzed.|||Percentage of days||Standard Deviation|Mean
2638620|NCT01772134|Secondary|Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 84|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. The weighted mean was calculated using the 24-hour serial FEV1 measurements at Day 84, which included pre-dose, and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 84 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline and day by treatment interactions.|Baseline and Day 84|ITT Population. Only those participants available at the indicated time point were analyzed.|||Liters||Standard Error|Least Squares Mean
2638631|NCT01771809|Secondary|Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA)|The anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (>=) 4.64. The number of participants with positive ADA was reported.|Baseline, Week 8, 16, 24, 40, 48, 64 and 156|"The SAS consisted of all enrolled participants who had received at least 1 dose of SHP647. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specific time points."|||Participants|||Count of Participants
2638920|NCT01769352|Secondary|Mean Change in Central Subfield Thickness at Week 12 From Baseline|Mean Change in Central Subfield Thickness (µm) at Week 12 from Baseline|Baseline and Week 12||||µm||Standard Error|Mean
2638621|NCT01772134|Primary|Change From Baseline in the Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Treatment Day 84 (i.e., at Week 12). Baseline trough FEV1 is the mean of the two assessments made at -30 and -5 minutes (min) pre-dose on Treatment Day 1. Change from Baseline was calculated as the Day 85 value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made at -30 and -5 min pre-dose on Treatment Day 1), smoking status, day, day by Baseline and day by treatment interactions.|Baseline and Day 85|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study medication in the Treatment Period. Only those participants available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2638622|NCT01771991|Secondary|Cervical Spine Range of Motion|"Determine the effect of the treatment on Range of Motion over time. Cervical spine rotation was measured by a physical therapist using a goniometer.~A goniometer is an instrument that either measures an angle or allows an object to be rotated to a precise angular position. Results are documented in degrees.~Baseline measurements were compared with post-treatment measurements. A larger post-treatment measure when compared to the baseline measurement would indicate an increase of the cervical spine range of motion."|3 months|Patients with pre-treatment and post-treatment measures.|||degrees||Standard Deviation|Mean
2638623|NCT01771991|Secondary|Determine the Pain From Radiation Related Fibrosis in Head and Neck Cancer Patients|"Subjects use the numeric verbal pain rating scale (0-10 scale specified for neck region with 0 being no pain and 10 extreme pain).~0 - Pain free~- Very minor annoyance-occasional minor twinges~- Minor annoyance-occasional, does not interfere with activities~- Annoying enough to be distracting~- Can be ignored if you are really involved in your work, but still distracting,~- Can't be ignored for more than 30 minutes. Interrupts some activities.~- Can't be ignored for any length of time, but you can still go to work and participate in social activities.~- Make it difficult to concentrate, interferes with sleep, you can still function with effort, prevents doing daily activities~- Physical activity severely limited. You can read and converse with effort. Hard to do anything~- Unable to do anything, Can't bear the pain~- Bad as it could be, nothing else matters~Differences between baseline scores and 3 month score"|From baseline to 3 months.|All patients who had a pre-treatment and post-treatment pain score.|||score on a scale||Standard Deviation|Mean
2638624|NCT01771991|Secondary|Determine the Quality of Life Impact From Radiation Related Fibrosis in Head and Neck Cancer Patients|"Metrics are measured via analysis of Health Related Quality of Life questionnaire.~Functional Assessment of Cancer Therapy for Head and Neck Cancer (FACT H&N) questionnaire was used to evaluate the quality of life in patient receiving treatment of head and neck cancer. Sub-categories of Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, and Head & Neck Additional Concerns are included. Each category used a 5-point Likert scale ranged from 0 to 4 with 0= Not at all (no affect on daily activities) to 4=Very much (significant affect on daily activities).~Sub-categories were not analyzed individually. All were summed together for total score. Analysis was done comparing baseline scores and end of treatment scores.~Maximum scale total = 156 (answer of 4 to all items) Minimum scale total = 0 (answer of 0 to all items)"|3 months|The analysis population are those who filled out the Quality of Life questionnaire at baseline and 3 months.|||score on a scale||Standard Deviation|Mean
2638625|NCT01771991|Primary|Improvement in Neck Fibrosis|Number of participants with improvement in fibrosis as defined as a one point improvement on the fibrosis scale using the grading scale outlined in CTCAE 4.03, page 46.|3 months|All subjects randomized between August 2012 and May 2013.|||participants|||Number
2638626|NCT01771965|Primary|Change in Treatment Engagement (Number of Participants Entering Treatment)|The investigators will be asking about service utilization since baseline interview. Zero = no mental health treatment and 1 = received mental health treatment.|30 days after baseline|Only 7 of the 10 control participants and 4 of the 9 intervention participants completed follow-up assessments.|||Participants|||Count of Participants
2638627|NCT01771913|Other Pre-specified|Number of Participants Experiencing Fat Necrosis in the Postoperative Period|Fat necrosis may occur whenever a fat graft is performed and it has clinical relevance. It can emerge as oil cysts or small nodules a little bit painful. In mammograms of normal breasts, fat necrosis present as cysts or micro calcifications that present a benign appearance. In breast reconstruction patients, fat necrosis, despite its benign characteristics, can suggest cancer recurrence.|up to 3 years||||participants|||Number
2638628|NCT01771913|Secondary|Immunophenotyping|Immunophenotyping of the fresh stromal vascular fraction of both groups. Immunophenotyping or flow cytometry measures how many cells, in a sample, express a specific surface marker. A surface marker or a group of markers may characterize a specific cell type. The software that accompanies the flow cytometer determines the number of cells (in percentage) that express the tested surface marker.|baseline|we had technical problems in processing 4 tissue samples in each arm.|||percentage of expression for CD90||Standard Deviation|Mean
2638629|NCT01771913|Primary|Volume Maintenance|Volumetry of the reconstructed breasts will be accomplished through MRI and OsiriX software. Osirix software allows breast volume calculation through the determination of regions of interest (ROIs) on an MRI sequence. Once the pre (V1) and postoperative (V2) volumes were determined the following formula was applied: (V2 - V1) X 100/graft volume. The result, expressed in percentage, expresses graft volume persistence.|up to 1 year||||percentage of graft volume persistency||Standard Deviation|Mean
2638630|NCT01771809|Secondary|Number of Participants With Positive Neutralizing Antibodies (NAb)|"The positive Neutralizing Antibodies (NAb) was defined as NAb titer greater than or equal to (>=) 0.903. The number of participants with NAb was reported. Here inconclusive refers to participants who were neither reported as positive nor negative for NAb and anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (>=) 4.64."|Baseline, Week 8, 16, 24, 40, 48, 64 and 156|"Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specific time points with non-missing ADA sample."|||Participants|||Count of Participants
2638670|NCT01770509|Secondary|Alleviation of Pain|Pain in week 4, assessed by the patient on a visual analogue pain score from 0 to 10. 0 represents no pain, 10 represents worst pain|4 weeks||||units on a scale||Standard Deviation|Mean
2638632|NCT01771809|Secondary|Serum Trough Concentrations of SHP647 Versus Time|Serum trough concentrations of SHP647 versus time was reported.|Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156|The pharmacokinetic (PK) set consisted of all participants who received at least 1 dose of SHP647 and for whom at least 1 postdose PK sample was collected. Here 'Number of Participants Analyzed' refers to the number of participants evaluable for specific timepoint.|||Micrograms/liter (ug/L)||Standard Deviation|Mean
2638633|NCT01771809|Secondary|Percentage of Participants With Mucosal Healing at Week 16|Mucosal healing was defined as an absolute Mayo subscore for endoscopy of 0 or 1 (based on centrally read score) as assessed by flexible sigmoidoscopy or colonoscopy. The Mayo score is a tool designed to measure disease activity for ulcerative colitis (UC). The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy, and physician's global assessment [PGA]) each graded 0 to 3 with the higher score indicating more severe disease activity. The percentage of participants with mucosal healing at week 16 was reported.|Week 16|SAS consisted of all enrolled participants who had received at least 1 dose of SHP647.|||Percentage of participants|||Number
2638634|NCT01771809|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product or medical device; the event did not need to necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect. Number of participants with TEAEs, STEAEs, and those withdrew from treatment due to TEAEs were reported.|From start of study drug administration up to 168 weeks|SAS consisted of all enrolled participants who had received at least 1 dose of SHP647.|||Participants|||Count of Participants
2638635|NCT01771666|Secondary|Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes|"The outcome is expressed as the number of participants whose resected sentinel lymph nodes (SLN) bound 99technetium-sulfur colloid (99tech), a tumor marker radiolabel; Indocyanine Green (IC-GREEN; GREEN), a fluorescent label; or isosulfan blue (IS-BLUE; BLUE), a visual dye. Results are expressed as:~Any HOT = Those whose samples bound 99tech.~Not HOT = Those whose samples did not bind 99tech.~Not HOT (also no BLUE, no GREEN) = Those whose samples did not bind 99tech; and also did not bind IC-GREEN nor IS-BLUE.~HOT, BLUE, GREEN = Those whose samples bound all of 99tech; IC-GREEN; and IS-BLUE.~HOT, no BLUE, no GREEN = Those whose samples bound 99tech, but did not bind either of IC-GREEN nor IS-BLUE.~HOT, GREEN only, no BLUE = Those whose samples bound 99tech and IC-GREEN, but did not bind IS-BLUE."|1 day||||participants|||Number
2638636|NCT01771666|Primary|Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN)|Number of women with agreement of the two dies [ie, isosulfan blue (IS-BLUE) and indocyanine green (IC-GREEN)] on all nodes examined in the lymphatics and arm-draining lymph nodes, during nodal staging procedures for surgery to treat breast cancer with curative intent.|1 day||||Participants|||Count of Participants
2638637|NCT01771250|Primary|VLDL-TG Clearance Rate|VLDL-TG clearance rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.|Day 22: 240 min to 420 min|All participants who were randomized and received at least one dose of study drug.|||milliliters per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
2638638|NCT01771250|Primary|VLDL-TG Oxidation Rate|VLDL-TG oxidation rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.|Day 22: 240 min to 420 min|All participants who were randomized and received at least one dose of study drug.|||μmol/min||Geometric Coefficient of Variation|Geometric Mean
2638639|NCT01771250|Primary|VLDL-TG Secretion Rate|VLDL-TG secretion rates are calculated at steady state during dosing with insulin peglispro and insulin glargine.|Day 22: 240 min to 420 min|All participants who were randomized and took at least one dose of study drug.|||μmol/min||Geometric Coefficient of Variation|Geometric Mean
2638640|NCT01771250|Primary|Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations|VLDL-TG average total concentration calculated at steady state from 240 to 420 minutes during dosing with insulin peglispro and insulin glargine.|Day 22: 240 minutes (min) to 420 min|All participants who were randomized and received at least one dose of study drug.|||micromole per Liter (μmol/L)||Geometric Coefficient of Variation|Geometric Mean
2638641|NCT01771172|Primary|Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System.||within the first day||||percentage of success|||Number
2638642|NCT01770860|Secondary|Subjective Assessment of Wound Healing|Until healed, subjects will be shown photographs of each wound they have not previously classified as healed at each daily visit, and asked to determine if the wound is healed. Yes or No responses will be recorded, along with text entries of the reasons for the response. This outcome measure reports the number of subjects who report that the wound has healed.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.|||Participants|||Number
2638643|NCT01770860|Secondary|Subjective Assessment of Itch|Until healed, itch assessments by the participant will be recorded daily for each wound site as either Present (P) or Absent (A). Percentage of itch was derived as the itch presence times over study period divided by visit number 13.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.|||percentage of itching||Standard Deviation|Mean
2638644|NCT01770860|Secondary|Subjective Assessment of Pain|Until healed, pain assessments by the participant will be recorded daily for each wound site as either Present (P) or Absent (A). Percentage of pain was derived as the pain presence times over study period divided by visit number 13.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.|||percentage of pain||Standard Deviation|Mean
2639031|NCT01768325|Primary|Diagnostic Accuracy.||36 months|One patient was lost to follow up. Final diagnosis was unconfirmed.|||Percentage of participants|||Number
2639032|NCT01768325|Secondary|Overall Specimen Length||36 months||||mm||Standard Deviation|Mean
2638645|NCT01770860|Secondary|Maceration|Until healed, maceration (a slight whitening of the skin around the wound compared to the surrounding unbandaged area) will be scored as P=Present or A=Absent. Percentage of maceration was derived as the maceration presence times over study period divided by visit number 13.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.|||percentage of maceration||Standard Deviation|Mean
2638646|NCT01770860|Secondary|Edema|Until healed, edema (swelling) of each wound bed and surrounding skin will be scored daily on a scale of 0-10, where 0=None and 10=Most severe. Mean Edema was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed using a mixed model.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.|||scores on a scale||Standard Deviation|Mean
2638647|NCT01770860|Secondary|Erythema|Until healed, erythema (redness) of each wound bed and surrounding skin will be scored daily on a scale of 0-10, where 0=None and 10=Most severe. Erythema was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed here using a mixed model.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.|||scores on a scale||Standard Deviation|Mean
2638648|NCT01770860|Secondary|Forced Rank Score|The wound evaluator will rank the overall appearance of all five wounds in relation to each other on a daily basis until all five are healed on a scale of 1 to 5, where 1= Worst and 5=Best. The forced Rank was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed using a mixed model.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.|||scores on a scale||Standard Deviation|Mean
2638649|NCT01770860|Primary|Time to Healing (Days)|Wound epithelialization will be recorded daily for each wound (until healed) by the doctor on a scale of 0-5, where 0= No presence of epithelialization (no sign of healing), a bandage is necessary and 5=Wound is 100% epithelialized (healed), no bandage necessary. The median time to healing will be estimated from the survival curves using the Kaplan-Meier method for each test product. Time to healing is defined as the time from wounding to 12:00 pm of the day the wound is 100% epithelialized (receives a score of 5). If the wound is not 100% epithelialized on Day 14 or on the last day of visit, Time to healing will be considered as censored.|within 14 days|The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. Forty six subjects were enrolled but one withdrew before randomization.|||days||95% Confidence Interval|Median
2638650|NCT01770743|Primary|Incidence of Immunologically Significant Adverse Events of Special Interest|Incidence of immunologically significant adverse events of special interest as defined by the Center for Biologics Evaluation and Research from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination|From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination|Safety Population (subjects who received at least one dose of IMP)|||participants|||Number
2638651|NCT01770743|Primary|Incidence of Clinical Laborabory Abnormalities|"Incidence of clinical laboratory abnormalities throughout the study (up to Day 84).~Clinical laboratory abnormalities are presented as the total of Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research: Guidance for Industry. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Within each laboratory parameter, subjects are counted once for their most severe occurrence of clinical laboratory abnormality."|From the time of first immunization on Day 0 to Day 84|Safety Population (subjects who received at least one dose of IMP)|||participants|||Number
2638652|NCT01770743|Primary|Incidence of Reactogenicity By Severity|"Incidence of solicited systemic reactions and solicited injection site reactions each day for 7 days following each vaccination using subject e-diaries by severity.~Reactions were graded using the following scale (note, for redness and swelling, the diameter [greater of two perpendicular measurements] was assessed by the subject using an injection site measurement tool):~Grade 0 (Absent): Symptom not present; Grade 1 (Mild): Symptom present but does not interfere with activities of daily living, or affected area (redness, swelling) measures <3 cm; Grade 2 (Moderate): Symptom causes some interference with activities of daily living, or affected area (redness, swelling) measures 3 - 10 cm; Grade 3 (Severe): Symptom prevents activities of daily living or requires treatment, or affected area (redness, swelling) measures > 10 cm.~For each reaction, subjects are counted once across all vaccinations at the highest reported level of severity."|For 7 days following each vaccination on Days 0, 14, 28|Safety Population (subjects who received at least one dose of IMP)|||participants|||Number
2638653|NCT01770743|Primary|Incidence of Serious Adverse Events|Incidence of serious adverse events, from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination|From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination|Safety Population (subjects who received at least one dose of IMP)|||participants|||Number
2638654|NCT01770743|Secondary|TNA Seroconversion Rate|Immunogenicity measured by the percentage of subjects who have seroconverted (defined as a 4-fold increase over Day 0 in TNA NF50 value) at Days 21, 28, 35, 42, 49, 63, and 84|Up to Day 84|Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).|||percentage of participants||95% Confidence Interval|Mean
2638655|NCT01770743|Secondary|TNA Level at Day 28|Immunogenicity measured by the percentage of subjects with Day 28 TNA NF50 values greater than or equal to threshold|Day 28|Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).|||percentage of participants||95% Confidence Interval|Mean
2638656|NCT01770743|Secondary|TNA Level at Day 42|Immunogenicity measured by the percentage of subjects in each study arm with Day 42 TNA NF50 values greater than or equal to threshold|Day 42|Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).|||percentage of participants||95% Confidence Interval|Mean
2638657|NCT01770743|Primary|Incidence of Adverse Events|Incidence of adverse events (including assessment of symptoms, physical exam findings, clinical laboratory tests, and vital signs) from the time of the first immunization on Day 0 through Day 84|From the time of the first immunization on Day 0 through Day 84|Safety Population (subjects who received at least one dose of IMP)|||participants|||Number
2638658|NCT01770743|Primary|Toxin Neutralizing Antibody (TNA) Level at Day 63|Immunogenicity measured by the lower bound (LB) of the 95% confidence intervals (CIs) for the proportion of subjects in each study arm with Day 63 TNA 50% neutralization factor (NF50) values greater than or equal to threshold|Day 63|Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data).|||percentage of participants||95% Confidence Interval|Mean
2638659|NCT01770691|Primary|Mean Percentage of Pad Weight Gain (PWG) Change|"All eligible subjects underwent a 3-day Pad period to establish baseline Average PWG. During this period, pre-weighed pads were worn for 8 hours a day and subjects were asked to perform predefined physical activities and drink a certain amount of liquid, daily. Pads were collected and weighed in the clinic to determine baseline urine leakage. Subjects then used SMDs or the cleared TIPI (G3) with pads for up to 8 hours. The average PWG tests results with the TIPI devices were compared to the average PWG 8 hrs test without the device and were presented as percentages.~The efficacy endpoint for the study was mean percent change of PWG using a certain device compared to the values obtained at the baseline period, as calculated by the following formula:~% Reduction = 1-(Device/Baseline )*100~Where, Device = the average pad weight gain (PWG) during device usage. Baseline = the average pad weight gain (PWG) during the days of baseline period."|up to 8 hours of use||||Mean percentage of PWG change||Standard Deviation|Mean
2638660|NCT01770652|Primary|Fe24 for Serum Deferiprone and Deferiprone 3-O-glucuronide|"Fe24 (fraction of dose excreted in urine from time zero to 24 hours) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Urine samples were collected at the intervals of -2 to 0 hours pre-dose and 0 to 2, 2 to 4, 4 to 8, 8 to 12, and 12 to 24 hours post-dose.~Some of the Fe24 values were over 100% which could be explained by variability in urine collection (e.g. incomplete collection of urine into the container) and volume measurement, as well as analytical imprecision."|24-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter|||% of dose excreted in urine from 0-24 hr||Standard Deviation|Mean
2638661|NCT01770652|Primary|Ae24 for Urine Deferiprone and Deferiprone 3-O-glucuronide|Ae24 (the amount excreted in urine from time zero to 24 hours) was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Urine samples were collected at the intervals of -2 to 0 hours pre-dose and 0 to 2, 2 to 4, 4 to 8, 8 to 12, and 12 to 24 hours post-dose.|24 hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||mg||Standard Deviation|Mean
2638662|NCT01770652|Primary|T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide|T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24 hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||hour||Standard Deviation|Mean
2638663|NCT01770652|Primary|AUC Zero to Infinity (AUC0-∞) for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUC0-∞ was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24 hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||μg*h/mL||Standard Deviation|Mean
2638664|NCT01770652|Primary|Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|"Tmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.~The results of the Tmax parameter are reported as the median and range (other parameters are reported as mean and standard deviation)."|24 hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||hour||Full Range|Median
2638665|NCT01770652|Secondary|Safety and Tolerability of Ferriprox® in Subjects With Renal Impairment.|The number of participants who experienced adverse events (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests) following a single dose of Ferriprox.|From time of dosing until 72 hours post-dose||||participants|||Number
2638666|NCT01770652|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal, mild, moderate and severe renal impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The pharmacokinetic population included all subjects who had sufficient data to derive the value of at least one pharmacokinetic parameter.|||μg/mL||Standard Deviation|Mean
2638667|NCT01770509|Secondary|Time to Complete Closure||4 weeks|Data was not collected as time to ulcer closure has been beyond the study period in the majority of patients||||||
2638668|NCT01770509|Secondary|Incidence of Adverse Events|Number of adverse effects at 4 weeks|4 weeks||||number of adverse effects|||Number
2638669|NCT01770509|Secondary|Incidence of Adverse Events at 4 Weeks|Number of patients with adverse effects at 4 weeks|4 weeks||||Number of patients with adverse events|||Number
2638671|NCT01770509|Primary|Logarithm of Percentage of Baseline Ulcer Size|Logarithm of percentage of baseline ulcer size. Log (ulcer area at 4 weeks/ulcer area at baseline *100) Ulcer area measured as longest ulcer length x longest ulcer width|From start of treatment to 4 weeks|Analysis is based on measures from each ulcer, when some participants had more than one ulcer|||Mean of log (percentage of baseline area|Ulcers|Standard Deviation|Mean
2638672|NCT01770483|Secondary|Normalization of Alanine Transferase Test|Liver function test,showing resolution of the inflammation of liver parenchyma|48week|"Sample size has been calculated using Epi-Info 3.5.1 with the following assumptions.~Reported ETR with Interferon + Ribavarin = 44 % Expected ETR with Interferon + Ribavarin + Nitazoxanide = 80 % Confidence Level = 95 % Power of Study = 80% Calculated Sample Size = 66 i.e. 33 in each group."|||participants|||Number
2638673|NCT01770483|Primary|Sustained Viral Response,|Sustained viral response ,is negative Hepatitis C Virus(PCR)RNA test six months after end of treatment.|48 WEEK|"Sample size has been calculated using Epi-Info 3.5.1 with the following assumptions.~Reported ETR with Interferon + Ribavarin = 44 % Expected ETR with Interferon + Ribavarin + Nitazoxanide = 80 % Confidence Level = 95 % Power of Study = 80% Calculated Sample Size = 66 i.e. 33 in each group."|||participants|||Number
2638674|NCT01770431|Secondary|Postoperative Survival Period|Assess Postoperative survival period|Week 94 after took medicine||||weeks||Standard Error|Median
2638675|NCT01770431|Primary|Incidence of Recurrence and Metastasis After Hepatectomy|At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy.|Week 94 after took medicine||||Participants|||Count of Participants
2638676|NCT01770392|Secondary|Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz)|"AUC0-tz represents the area under the plasma concentration-time curve of nintedanib from 0 to the last quantifiable analyte plasma concentration.~For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib|TS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2638677|NCT01770392|Primary|Maximum Measured Concentration (Cmax)|"Cmax represents the maximum concentration of nintedanib in plasma. For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib|TS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2638678|NCT01770392|Primary|Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞)|"AUC0-∞ represents the Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity.~For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hour (h) before the first drug administration and 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 36h, 48h and 72h after administration of nintedanib|TS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2638679|NCT01770379|Secondary|Percentage of Participants Achieving ACR50|"ACR50 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 50% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).~The ACR50 response results at week 24 used non-responder imputation."|Week 24|Full analysis set: the full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment|||Percentage of patients|||Number
2638680|NCT01770379|Secondary|Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)|"The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, are you able to... perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement."|Week 24|Full analysis set (FAS): The FAS was comprised of all patients from the randomized set to whom study treatment had been assigned.|||units on a scale||Standard Error|Least Squares Mean
2638681|NCT01770379|Secondary|Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP)|The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.|Week 24|Full analysis set (FAS): The FAS was comprised of all patients from the randomized set to whom study treatment had been assigned.|||Units on a scale||Standard Error|Least Squares Mean
2638682|NCT01770379|Primary|Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).|"ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).~The ACR20 response results at week 24 used non-responder imputation."|Week 24|Full analysis set (FAS): The FAS was comprised of all patients from the randomized set to whom study treatment had been assigned.|||percentage of participants|||Number
2638683|NCT01770366|Primary|BMI||3 months post surgery||||kg/m2||Standard Deviation|Mean
2639058|NCT01768013|Primary|Pharmacokinetic: Cmax of MC1080|The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined|Day 7||||pg/mL||Standard Deviation|Mean
2638684|NCT01770353|Secondary|Expansion Phase: SN-38 AUC(0-tlast)|For the Expansion phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m^2 MM-398 FBE (40 to 80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Expansion phase was 0.600 ng/mL. The mean AUC(0-tlast) is presented for dose levels in the Expansion phase for which data was collected. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.|Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.|The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables & sufficient number of plasma concentrations to estimate main PK parameters [Cmax, AUC]); analysis was within the sample stability period to estimate main PK parameters.|||ng*h/mL||Full Range|Mean
2638685|NCT01770353|Secondary|Expansion Phase: Irinotecan AUC(0-tlast)|For the Expansion phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m^2 MM-398 FBE (40 to 80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean AUC(0-tlast) is presented for the Expansion phase. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.|Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.|The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables & sufficient number of plasma concentrations to estimate main PK parameters [Cmax, AUC]); analysis was within the sample stability period to estimate main PK parameters.|||mcg*h/mL||Full Range|Mean
2638686|NCT01770353|Secondary|Pilot Phase: SN-38 AUC(0-tlast)|In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma following a dose of 70 mg/m^2 MM-398 FBE (80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Pilot phase was 0.441 ng/mL. The mean AUC(0-tlast) is presented for the Pilot phase.|Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.|The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables & sufficient number of plasma concentrations to estimate main PK parameters [Cmax, AUC]); analysis was within the sample stability period to estimate main PK parameters.|||ng*h/mL||Full Range|Mean
2638687|NCT01770353|Secondary|Pilot Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) for Irinotecan|In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma following a dose of 70 mg/m^2 MM-398 FBE (80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean AUC(0-tlast) is presented for the Pilot phase.|Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.|The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables & sufficient number of plasma concentrations to estimate main PK parameters [Cmax, AUC]); analysis was within the sample stability period to estimate main PK parameters.|||mcg*hours/mL (mcg*h/mL)||Full Range|Mean
2638688|NCT01770353|Secondary|Expansion Phase: SN-38 Cmax|For the Expansion phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m^2 MM-398 FBE (40 to 80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Expansion phase was 0.600 ng/mL. The mean Cmax is presented for dose levels in the Expansion phase for which data was collected. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.|Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.|The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables & sufficient number of plasma concentrations to estimate main PK parameters [Cmax, AUC]); analysis was within the sample stability period to estimate main PK parameters.|||ng/mL||Full Range|Mean
2638695|NCT01770353|Secondary|Expansion Phase: CBR for Cohort 3 (CNS Assessment)|CBR was defined as the percentage of subjects with a BOR characterised as a CR at any time, PR at any time, or SD ≥ 24 weeks relative to the total number of evaluable subjects. The CBR is presented for CNS assessment for Cohort 3.|Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.|The efficacy evaluable population included all subjects who received at least 1 dose of MM-398. Percentages are based on the number of subjects in the efficacy evaluable population in the corresponding phase/cohort. Data is presented for Cohort 3 which included subjects with brain metastasis, and who underwent CNS assessment using mRECIST criteria.|||percentage of participants||95% Confidence Interval|Number
2638921|NCT01769352|Primary|Mean Change in Best-Corrected Visual Acuity at Week 12 From Baseline|Mean change in best-corrected visual acuity (Letter Score) at Week 12 from Baseline. The Early Treatment of Diabetic Retinopathy Study (ETDRS) score is measured on a scale from 5 to 100. The higher the score on this scale, the better is the patients vision.|Baseline and Week 12||||letters||Standard Error|Mean
2638689|NCT01770353|Secondary|Expansion Phase: Irinotecan Cmax|For the Expansion phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m^2 MM-398 FBE (40 to 80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean Cmax is presented for the Expansion phase. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.|Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.|The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables & sufficient number of plasma concentrations to estimate main PK parameters [Cmax, AUC]); analysis was within the sample stability period to estimate main PK parameters.|||mcg/mL||Full Range|Mean
2638690|NCT01770353|Secondary|Pilot Phase: SN-38 Cmax|In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma following a dose of 70 mg/m^2 MM-398 FBE (80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Pilot phase was 0.441 ng/mL. The mean Cmax is presented for the Pilot phase.|Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.|The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables & sufficient number of plasma concentrations to estimate main PK parameters [Cmax, AUC]); analysis was within the sample stability period to estimate main PK parameters.|||ng/mL||Full Range|Mean
2638691|NCT01770353|Secondary|Pilot Phase: Maximum Observed Plasma Concentration of Irinotecan (Cmax)|In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma following a dose of 70 mg/m^2 MM-398 FBE (80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean Cmax is presented for the Pilot phase.|Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.|The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables & sufficient number of plasma concentrations to estimate main PK parameters [Cmax, AUC]); analysis was within the sample stability period to estimate main PK parameters.|||mcg/mL||Full Range|Mean
2638692|NCT01770353|Secondary|Expansion Phase: Irinotecan and SN-38 Tmax|For the Expansion phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) and SN-38 (metabolite) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m^2 MM-398 FBE (40 to 80 mg/m^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL and for SN-38 the LLOQ for the Expansion phase was 0.600 ng/mL. The median tmax is presented for dose levels in the Expansion phase for which data was collected. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.|Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.|The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables & sufficient number of plasma concentrations to estimate main PK parameters [Cmax, AUC]); analysis was within the sample stability period to estimate main PK parameters.|||hours||Full Range|Median
2638693|NCT01770353|Secondary|Pilot Phase: Time to Reach Maximum Plasma Concentration of Irinotecan and SN-38 (Tmax)|In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) and SN-38 (metabolite) in plasma following a dose of 70 mg/m^2 MM-398 FBE (80 mg/m^2 MM-398 salt-base equivalent [SBE]). The pharmacokinetic (PK) analysis was based on non-compartmental analysis. Any plasma concentrations below the lower limit of quantification (LLOQ) were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 micrograms per millilitre (mcg/mL), and for SN-38 the LLOQ for the Pilot phase was 0.441 nanograms per millilitre (ng/mL). The median tmax is presented for the Pilot phase.|Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.|The PK set included subjects who received at least 1 dose of MM-398, blood samples were collected at the predefined points (with no major protocol deviations affecting PK variables & sufficient number of plasma concentrations to estimate main PK parameters [Cmax, AUC]); analysis was within the sample stability period to estimate main PK parameters.|||hours||Full Range|Median
2638694|NCT01770353|Secondary|Pilot Phase + Expansion Phase: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs) Related to MM-398|The number of subjects who experienced a TEAE reported to be related to MM-398 by the Investigator are presented for the Pilot and Expansion phases. An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing.|From MM-398 treatment start up to 30 days after last dose.|The MM-398 safety population consisted of all subjects who received at least 1 dose of MM-398. Data was combined into 1 arm for the Expansion Phase as all subjects had BC.|||participants|||Number
2638749|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Total Body BMC, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48."|Baseline and wk 48||||% change*wks||Full Range|Median
2638696|NCT01770353|Secondary|Pilot Phase + Expansion Phase: Clinical Benefit Response (CBR) (Non-CNS Assessment)|CBR was defined as the percentage of subjects with a BOR characterised as a CR at any time, PR at any time, or SD ≥ 24 weeks relative to the total number of evaluable subjects. The CBR is presented for non-CNS assessments.|Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.|The efficacy evaluable population included all subjects who received at least 1 dose of MM-398. Percentages are based on the number of subjects in the efficacy evaluable population in the corresponding phase/cohort.|||percentage of participants||95% Confidence Interval|Number
2638697|NCT01770353|Secondary|Expansion Phase: Median DOR for Cohort 3 (CNS Assessment)|DOR was defined as the time from first documentation of response (CR or PR whichever occurred first, based on Investigator assessment using mRECIST criteria) to the date of disease progression or to death due to any cause, whichever occurred first. DOR was computed for subjects who had CR or PR as the BOR. For subjects who did not have a qualifying progressive disease or death, the date of censoring was the date when the last valid tumour assessment determined a lack of progression. The median DOR is presented for CNS assessments for Cohort 3.|Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.|The efficacy evaluable population included all subjects who received at least 1 dose of MM-398. Data is presented for the number of subjects who had a BOR classification of CR or PR. Data is presented for Cohort 3 only which included subjects with brain metastasis, and who underwent CNS assessment using mRECIST criteria.|||months||Full Range|Median
2638698|NCT01770353|Secondary|Pilot Phase + Expansion Phase: Median Duration of Objective Response (DOR) (Non-CNS Assessment)|DOR was defined as the time from first documentation of response (CR or PR whichever occurred first, based on Investigator assessment using RECIST criteria) to the date of disease progression or to death due to any cause, whichever occurred first. DOR was computed for subjects who had CR or PR as the BOR. For subjects who did not have a qualifying progressive disease or death, the date of censoring was the date when the last valid tumour assessment determined a lack of progression. The median DOR is presented for non-CNS assessments for the Pilot phase and Cohorts 1-3.|Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.|The efficacy evaluable population included all subjects who received at least 1 dose of MM-398. Data is presented for the number of subjects who had a BOR classification of CR or PR.|||months||Full Range|Median
2638699|NCT01770353|Secondary|Expansion Phase: ORR for Cohort 3 (CNS Assessment)|The ORR was defined as the percentage of subjects with a BOR of either a CR or PR relative to the total number of evaluable subjects. Subjects with insufficient data for response classification were classified as non-responders for objective response. The ORR is presented for CNS assessments for Cohort 3.|Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.|The efficacy evaluable population included all subjects who received at least 1 dose of MM-398. Percentages are based on the number of subjects in the efficacy evaluable population in the corresponding phase/cohort. Data is presented for Cohort 3 which included subjects with brain metastasis, and who underwent CNS assessment using mRECIST criteria.|||percentage of participants||95% Confidence Interval|Number
2638700|NCT01770353|Secondary|Pilot Phase + Expansion Phase: Objective Response Rate (ORR) (Non-CNS Assessment)|The ORR was defined as the percentage of subjects with a BOR of either a CR or PR relative to the total number of evaluable subjects. Subjects with insufficient data for response classification were classified as non-responders for objective response. The ORR is presented for non-CNS assessments for the Pilot phase and Cohorts 1 - 3.|Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.|The efficacy evaluable population included all subjects who received at least 1 dose of MM-398. Percentages are based on the number of subjects in the efficacy evaluable population in the corresponding phase/cohort.|||percentage of participants||95% Confidence Interval|Number
2638701|NCT01770353|Secondary|Expansion Phase: BOR for Cohort 3 (CNS Assessment)|"BOR was defined as the best response by mRECIST criteria (CNS disease; Cohort 3) criteria per Investigator assessment, recorded from the first dose of MM-398 until disease progression or the start of new anti-cancer therapy and/or surgery.~Tumour response was classified as CR, PR, SD or PD. Classification of SD required at least 1 assessment of SD at least 4 weeks after starting treatment. Subjects were categorised as not evaluable if there was insufficient data for response classification. The BOR is presented for CNS assessments for Cohort 3."|Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.|The efficacy evaluable population included all subjects who received at least 1 dose of MM-398. Data is presented for Cohort 3 only which included subjects with brain metastasis, and who underwent CNS assessment using mRECIST criteria.|||Participants|||Count of Participants
2638702|NCT01770353|Secondary|Pilot Phase + Expansion Phase: BOR (Non-CNS Assessment)|"BOR was defined as the best response by RECIST version 1.1 (Non-CNS assessments) criteria per Investigator assessment, recorded from the first dose of MM-398 until disease progression or the start of new anti-cancer therapy and/or surgery.~Tumour response was classified as CR, PR, SD or PD. Classification of SD required at least 1 assessment of SD at least 4 weeks after starting treatment. Subjects were categorised as not evaluable if there was insufficient data for response classification. The BOR is presented for non-CNS assessments for the Pilot phase and Cohorts 1 - 3."|Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.|The efficacy evaluable population included all subjects who received at least 1 dose of MM-398.|||Participants|||Count of Participants
2638703|NCT01770353|Secondary|Expansion Phase: Median PFS for Cohort 3 (CNS Assessment)|"PFS was defined as the time in months from first dose of MM-398 to the date of radiologic disease progression by modified RECIST (mRECIST) criteria (CNS disease; Cohort 3) per Investigator assessment or death due to any cause, whichever occurred first.~The date of progression is defined as the earliest date that an overall tumour response of PD or death was recorded. For subjects who did not have a qualifying progressive disease or death, the date of censoring for PFS was the date when the last valid tumour assessment determined a lack of progression. The PFS assessed by the Investigator was analysed using the Kaplan-Meier method, and the median PFS based on CNS mRECIST assessment is provided for Cohort 3."|Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.|The efficacy evaluable population consists of all subjects who received at least 1 dose of MM-398. Data is presented for Cohort 3 only which included subjects with brain metastasis, and who underwent CNS assessment using mRECIST criteria.|||months||95% Confidence Interval|Median
2638704|NCT01770353|Secondary|Pilot Phase + Expansion Phase: Median Progression-free Survival (PFS) (Non-CNS Assessment)|"PFS was defined as the time in months from first dose of MM-398 to the date of radiologic disease progression by RECIST per Investigator assessment or death due to any cause, whichever occurred first.~The date of progression is defined as the earliest date that an overall tumour response of PD or death was recorded. For subjects who did not have a qualifying progressive disease or death, the date of censoring for PFS was the date when the last valid tumour assessment determined a lack of progression. The PFS assessed by the Investigator was analysed using the Kaplan-Meier method, and the median PFS based on non-CNS assessment is presented."|Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.|The efficacy evaluable population consists of all subjects who received at least 1 dose of MM-398.|||months||95% Confidence Interval|Median
2638705|NCT01770353|Primary|Expansion Phase: Best Overall Tumour Response (BOR) by Tumour FMX Uptake Classification at 16 - 24 Hours Post-FMX Dose|FMX tumour uptake was classified as 'low tumour uptake' or 'high tumour uptake', and was determined for 16 to 24-hours post-FMX dosing. The FMX uptake in a subject's lesions was classified using the median of the baseline-corrected FMX values at that timepoint across all subjects. The best radiological overall tumour response to MM-398 from the beginning to the end of the study was assessed using both the Investigator and imaging results per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 (Non-central nervous system [CNS] assessments; Cohorts 1, 2 and 3). Tumour response was classified as a Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). BOR is presented by tumour uptake classification at 16-24 hours post-FMX dose by cohort for the non-CNS RECIST assessment.|Expansion phase: C1D2 FMX phase, and every 8 weeks for RECIST assessments from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.|The pharmacodynamic evaluable population included all subjects who received at least 1 dose of MM-398 and who had pre-treatment FMX-MRI scan(s) and radiological scans at 8 weeks.|||Participants|||Count of Participants
2638706|NCT01770353|Primary|Expansion Phase: Impact of the Quality of MRI Scan on Tumour Evaluation|Feasibility of FMX quantitation in tumour lesion was assessed through the acquisition of baseline (pre-FMX dose) and follow-up (post FMX dose) scans of sufficient quality to enable quantitative analysis to be performed. Quality was assessed by summarising scans as adequate for tumour evaluation or suboptimal but for which evaluation was completed for evaluation. Two FMX-MRI scans were taken on Day 1 (pre-FMX dosing) and on Day 2 (16-24 hours post dose) of the FMX phase. One MRI scan was also taken at 1-4 hours post FMX dose (Day 1 of FMX phase) and at 2 weeks post FMX dose (Day 15 of the MM-398 phase). It was possible for a subject to have 2 FMX-MRI scans for the same visit and timepoint corresponding to a scan target location. The number of MRI scan results that were assessed to be adequate or suboptimal at each timepoint are presented.|Expansion phase Cycle 1: Pre FMX dose, 1-4 hours post FMX dose, 16-24 hours post FMX dose, 2 weeks Post FMX dose.|The pharmacodynamic evaluable population included all subjects who received at least 1 dose of MM-398 and who had pre-treatment FMX-MRI scan(s) and radiological scans at 8 weeks.|||examined scans|Scans||Number
2638707|NCT01770353|Primary|Pilot Phase: Tumour Levels of Irinotecan and SN-38 at Cycle 1 Day 4|Two tumour biopsies were collected 72 hours after the first MM-398 IV infusion during Cycle 1 of the MM-398 Treatment phase of the Pilot phase for determination of tumour levels of irinotecan and SN-38 (an active metabolite). The lesions selected for biopsy were based on the results of the FMX-MRI obtained on Days 1, 2 and 4 of the FMX phase, and were collected from a previously non-biopsied lesion. The first core biopsy was taken in the region of the tumour that showed the greatest signal change on either the T2 or T1 sequences, based on FMX-MRI. The second core biopsy was taken from the region that showed the least signal change based on FMX-MRI, avoiding areas of necrosis.|At Cycle 1 Day 4 in the Pilot phase.|The efficacy evaluable population included all subjects who received at least 1 dose of MM-398.|||nanograms per gram (ng/g)||Standard Deviation|Mean
2638708|NCT01770314|Secondary|Satisfaction With the Program|"We tested and analyzed participants' satisfaction with the program by asking the question: Overall, how satisfied were you with the lessons. They answered on a 4 point Likert scale: 1=Not at all satisfied, 2=Somewhat Satisfied, 3=Satisfied, 4 = Very satisfied. Higher values indicate higher satisfaction."|One-month followup assessment|We only analyzed satisfaction data for experimental participants who had indicated that they disposed of their unused opioid medications (n=17)|||units on a scale||Standard Deviation|Mean
2638709|NCT01770314|Primary|Self-efficacy - 8 Item Measure Taps Into Key Concepts Associated With Confidence for Managing Opioid Medications|"Responses are measured on a 4-point Likert scale (1= Not at all confident and 4= Extremely confident). The total Score range:8=least confident, 32=most confident.~How confident do you feel in your ability to do each of the following activities, today?~I can recognize side effects that are related to my opioid medicine.~I can avoid giving my opioid medicine to someone else. Etc.. 1 - Not at all confident 2 - Somewhat confident 3 - Very confident 4 - Extremely confident Items have been generated from literature. Content validity: assessed by asking two experts if items are important and relevant.~Internal consistency of the items in the pilot measure will be assessed (Cronbach's alpha).~Test-retest reliability will be explored by asking 50 participants in the control group to retake the pilot measure within 3-5 days of having taken the measure as part of the pretest."|Baseline - Day 1, Posttest - Day 16 (intervention took 15 days), One month Followup - at 1 month post-intervention||||units on a scale||Standard Error|Least Squares Mean
2638710|NCT01770145|Secondary|Change From Baseline in Gastric Emptying Time|A sub-group of subjects from 1 study site that have symptoms of gastroparesis were admitted to the clinic on 2 occasions to undergo gastroparesis procedures and assessments (once at the conclusion of the baseline L-dopa period and once at the conclusion of the APOKYN treatment period). Note, to do the second gastroparesis assessment, this sub-group of subjects had an extension for one extra day beyond the designated 7 day APOKYN treatment period (i.e., it will be 8 days) in order to keep the 7 day diary recording outpatient scope of work the same as the rest of the subjects in the study. The second inpatient period was also considered the end-of-study visit for this sub group.|L-Dopa Baseline Days 1-7 and APOKYN Treatment Days 1-8|A sub-group of subjects from 1 study site that have symptoms of gastroparesis were admitted to the clinic to undergo gastroparesis procedures and assessments (once at the conclusion of the baseline L-dopa period and once at the conclusion of the APOKYN treatment period)||||||
2639059|NCT01768013|Primary|Pharmacokinetic: Cmax of MC1080|The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined|Day 1||||pg/mL||Standard Deviation|Mean
2638711|NCT01770145|Primary|"Change From Baseline in Average Daily Time to on (TTO) by Subject Diary."|"Patients will record daily time to on or TTO following their regularly scheduled first L-Dopa dose in the baseline period for 7 consecutive days. Following initiation on Apokyn therapy, patients will inject Apokyn at their regularly scheduled L-Dopa time (L-Dopa dosing will be delayed by 40 minutes following Apokyn injection) and record time to on or TTO from the injection. Time to on for both periods will be recorded in a standardized subject diary. Daily TTO for the baseline period will be averaged for each subject and compared to the daily TTO for the same subject during the treatment period to assess APOKYN's effect on TTO."|L-Dopa Baseline Days 1-7 and APOKYN Treatment Days 1-7||||minutes||Standard Deviation|Mean
2638712|NCT01769612|Primary|Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results|"Comparison of CL Detect Rapid Test positive results with Microscopy and Culture results.~Note: only data where results for all three methods were available were included in the analysis."|within 1 hour after taking samples||||Participants|||Count of Participants
2638713|NCT01769586|Primary|Number of Patients Who Achieve Adequate Sedation to Allow Colonoscopy (Defined as MOAA/S ≤3)|Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. This scale ranges from 0 to 5, where 0 denotes general anesthesia, in which the patient has no response to painful stimuli, and 5 denotes a level of minimal sedation in which the patient is fully awake.|Approximately 10 minutes or less||||participants|||Number
2638714|NCT01769573|Secondary|Infection Rate|Infection rate per RG-HRV16 dose as measured by the percentage of individuals in the dosing group with detectable viral shedding.|4 weeks|The trial completed and met its goal before needing to enroll into the 10,000 TCID50 group.|||Participants|||Count of Participants
2638715|NCT01769573|Secondary|Mean Cold Symptom Score|The Mean Cold Symptom Score induced by each RG-HRV16 dose and by the placebo inoculation. The scale is called the Jackson Criteria for Cold Symptom Assessment. There are 13 variables of cold symptoms that each participant scores 0 (not present), 1 (mild), 2 (moderate) to 3 (severe), twice per day, once at 8am and once at 8pm. The 13 variables are: cough, nasal discharge, sneezing, stuffy nose, sore throat, headache, malaise, chilliness, shaking chills, fever, laryngitis, aching joints or muscles, and watery/burning eyes. The scores are added up for each time point, with a minimum score of 0 and a max score of 39 per time point. The highest score per day is taken and the highest score over the 7 day period starting from the day of the inoculation and for 7 days is deemed the mean cold symptom score. The higher the score, the more cold symptoms the participant reports and the worse the participant feels.|4 weeks|"For the manuscript, the 500 TCID50 group was excluded from this analysis due to incomplete data that could not be analyzed appropriately.~The trial completed and met its goal before needing to enroll into the 10,000 TCID50 group."|||peak symptom score||Standard Deviation|Mean
2638716|NCT01769573|Primary|Frequency of Adverse Events|Safety as determined by the frequency of adverse event reporting examined by RG-HRV16 dose.|4 weeks|The trial completed and met its goal before needing to enroll into the 10,000 TCID50 group.|||Participants|||Count of Participants
2638717|NCT01769573|Primary|Number of Participants With Colds With at Least Moderate Intensity|The percentage of colds of at least moderate intensity examined by RG-HRV16 dose; this will be measured by the number of subjects per RG-HRV16 dose group who have maximum weekly cold symptom score of ≥7 out of 39 on the modified Jackson criteria during the first week after inoculation|1 week|The trial completed and met its goal before needing to enroll into the 10,000 TCID50 group.|||Participants|||Count of Participants
2638718|NCT01769508|Secondary|Overall Survival (OS)|The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death|18 months||||months||95% Confidence Interval|Median
2638719|NCT01769508|Secondary|Time to Progression (TTP)|Time to progression is defined as the time between day 1 cycle 1 and time to first documented disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|18 months||||months||95% Confidence Interval|Median
2638720|NCT01769508|Secondary|Toxicity Profile for Treated Patients|Defined as the frequency of adverse events for patients who received at least one dose of study treatment, and assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.|18 months|All treated patients|||participants|||Number
2638721|NCT01769508|Secondary|Progression Free Survival (PFS)|The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|18 months||||months||95% Confidence Interval|Median
2638722|NCT01769508|Primary|Safety and Optimal Dose of Regimen|An additional primary objective is to evaluate the safety and optimal dose of lapatinib when added to 5-FU, oxaliplatin and radiation therapy.|18 months||||mg QD Lapatinib|||Number
2638723|NCT01769508|Primary|Pathologic Complete Response Rate (pCR Rate)|Defined as the absence of invasive tumor in esophagogastric and lymph node tissue removed at time of surgery, as judged by the local pathologist. An improvement in pCR rate from 30 percent (historical) to 50 percent is the primary efficacy endpoint.|18 months|All patients who underwent surgery|||participants|||Number
2638724|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Week 48 (or Last Visit on Study)|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the second Extension Phase visit (Last- EPH2)"|Wk 48 (or last available measurement on study), Wk 96|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||g||Full Range|Median
2638790|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UGluc|"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]"|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||(mg/dL)/ weeks||Full Range|Median
2638725|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Week 48 (or Last Visit on Study)|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the first Extension Phase visit (Last- EPH1)"|Wk 48 (or last available measurement on study), Wk 72|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||g||Full Range|Median
2638726|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH2 From Baseline|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)"|Baseline and wk 96|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||g||Full Range|Median
2638727|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Total Body BMC Change at EPH1 From Baseline|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)"|Baseline and wk 72|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||g||Full Range|Median
2638728|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study)|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2).~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure."|Wk 48 (or last available measurement on study), Wk 96|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||z-score||Full Range|Median
2638729|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study)|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1)~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure."|Week 48 (or last available measurement on study), Week 72|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||z-score||Full Range|Median
2638730|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH2 From Baseline|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure."|Baseline, Week 96|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||z-score||Full Range|Median
2638731|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Z-score Change at EPH1 From Baseline|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure."|Baseline and wk 72|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||z-score||Full Range|Median
2639060|NCT01768013|Primary|Pharmacokinetic: AUClast of Calcipotriol|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined|Day 14||||h*pg/mL||Standard Deviation|Mean
2638732|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Week 48 (or Last Visit on Study)|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the second Extension Phase visit (Last- EPH2)"|W 48 (or last available measurement on study), Wk 96|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||g/cm^2||Full Range|Median
2638733|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Week 48 (or Last Visit on Study)|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the first Extension Phase visit (Last- EPH1)"|Wk 48 (or last available measurement on study), Wk 72|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||g/cm^2||Full Range|Median
2638734|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH2 From Baseline|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)"|Baseline and wk 96|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||g/cm^2||Full Range|Median
2638735|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Femoral Neck BMD Change at EPH1 From Baseline|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)"|Baseline and wk 72|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||g/cm^2||Full Range|Median
2638736|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Week 48 (or Last Visit on Study)|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2)~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure."|Wk 48 (or last available measurement on study), Wk 96|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||z-score||Full Range|Median
2638737|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Week 48 (or Last Visit on Study)|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1)~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure."|Wk 48 (or last available measurement on study), Wk 72|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||z-score||Full Range|Median
2638738|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH2 From Baseline|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure."|Baseline and wk 96|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||z-score||Full Range|Median
2638750|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Total Body BMC, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24."|Baseline and wk 24||||% change*wks||Full Range|Median
2638739|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Z-score Change at EPH1 From Baseline|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1).~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure."|Baseline and wk 72|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||z-score||Full Range|Median
2638740|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Week 48 (or Last Visit on Study)|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the second Extension Phase visit (Last - EPH2)"|Wk 48 (or last available measurement on study), Wk 96|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||g/cm^2||Full Range|Median
2638741|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Week 48 (or Last Visit on Study)|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the last measure on study and the first Extension Phase visit (Last - EPH1)"|Wk 48 (or last available measurement on study), Wk 72|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||g/cm^2||Full Range|Median
2638742|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH2 From Baseline|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the second Extension Phase visit (BL - EPH2)"|Baseline and wk 96|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||g/cm^2||Full Range|Median
2638743|NCT01769469|Secondary|Changes in BMD/BMC in the Extension Phase: Lumbar Spine BMD Change at EPH1 From Baseline|"For subjects in the extension phase of the study, the last measured values at the ATN 110 or ATN 113 study week 48 visit will be compared with those measured at the Extension Phase visit 1 (EPH 1, 24 weeks after the ATN 110 or ATN 113 study week 48 visit) and EPH 2 (48 weeks after the ATN 110 or ATN 113 study week 48 visit).~This measure shows the difference between the Baseline measure and the first Extension Phase visit (BL - EPH1)"|Baseline and wk 72|Subjects who meet specific bone or renal criteria at Week 48 of the ATN 110 or ATN 113 study will be followed for an additional 48 weeks in the Extension Phase.|||g/cm^2||Full Range|Median
2638744|NCT01769469|Secondary|Magnitude of Change in Total Body BMC at Week 48|The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).|Baseline and wk 48|Subjects with data for Baseline and Week 48|||fold change||Full Range|Median
2638745|NCT01769469|Secondary|Magnitude of Change in Femoral Neck BMD Z-score at Week 48|The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).|Baseline and wk 48|Subjects with data for Baseline and Week 48|||fold change||Full Range|Median
2638746|NCT01769469|Secondary|Magnitude of Change in Femoral Neck BMD at Week 48|The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).|Baseline and wk 48|Subjects with data for Baseline and Week 48|||fold change||Full Range|Median
2638747|NCT01769469|Secondary|Magnitude of Change in Lumbar Spine BMD Z-score at Week 48|"The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure."|Baseline and wk 48|Subjects with data for Baseline and Week 48|||fold change||Full Range|Median
2638748|NCT01769469|Secondary|Magnitude of Change in Lumbar Spine BMD at Week 48|The magnitude of change will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).|Baseline and wk 48|Subjects with data for Baseline and Week 48|||fold change||Full Range|Median
2638761|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UGluc, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48."|Baseline and wk 48||||mg*wks/dL||Full Range|Median
2638751|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Femoral Neck BMD Z-score, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48."|Baseline and wk 48||||z-score||Full Range|Median
2638752|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Femoral Neck BMD Z-score, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.~The time points at which data were collected were: weeks 4, 8, 12, and 24."|Baseline and wk 24||||z-score||Full Range|Median
2638753|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Femoral Neck BMD, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48."|Baseline and wk 48||||% change*wks||Full Range|Median
2638754|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Femoral Neck BMD, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24."|Baseline and wk 24||||% change*wks||Full Range|Median
2638755|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Lumbar Spine BMD Z-score, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48."|Baseline and wk 48||||z-score||Full Range|Median
2638756|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Lumbar Spine BMD Z-score, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The Z-score is the standard deviation around mean bone mineral density, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected in this group of healthy adolescents and young adults. An increase in Z-score would signify acceleration of accrual of bone mass, a positive outcome; a decrease in Z-score would signify either bone loss or failure to accrue the expected amount of bone mass, both of which are adverse outcomes. The Z-score is a normalized measure.~The time points at which data were collected were: weeks 4, 8, 12, and 24."|Baseline and wk 24||||z-score||Full Range|Median
2638757|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 48 in Lumbar Spine BMD, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48."|Baseline and wk 48||||% change*wks||Full Range|Median
2638758|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Percent Change From Baseline to Week 24 in Lumbar Spine BMD, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24."|Baseline and wk 24||||% change*wks||Full Range|Median
2638759|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in URBP/UCr Ratio, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48."|Baseline and wk 48||||mcg*wks/g||Full Range|Median
2638760|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in URBP/UCr Ratio, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24."|Baseline and wk 24||||mcg*wks/g||Full Range|Median
2638762|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UGluc, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24."|Baseline and wk 24||||mg*wks/dL||Full Range|Median
2638763|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UB2MG, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48."|Baseline and wk 48||||ng*wks/mL||Full Range|Median
2638764|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UB2MG, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24."|Baseline and wk 24||||ng*wks/mL||Full Range|Median
2638765|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in UCa/UCr Ratio, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48."|Baseline and wk 48||||ratio*weeks||Full Range|Median
2638766|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in UCa/UCr Ratio, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24."|Baseline and wk 24||||ratio*weeks||Full Range|Median
2638767|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in TRP, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48."|Baseline and wk 48||||% of phosphorus reabsorbed*wks||Full Range|Median
2638768|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in TRP, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24."|Baseline and wk 24||||% of phosphorus reabsorbed*wks||Full Range|Median
2638769|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in SCr, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48."|Baseline and wk 48||||mg*wks/dL||Full Range|Median
2638770|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in SCr, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24."|Baseline and wk 24||||mg*wks/dL||Full Range|Median
2638771|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in CTX, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48."|Baseline and wk 48||||pM*wks||Full Range|Median
2638772|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in CTX, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24."|Baseline and wk 24||||pM*wks||Full Range|Median
2638773|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in Osteocalcin (OC), by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48."|Baseline and wk 48||||mcg*wks/L||Full Range|Median
2638774|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in Osteocalcin (OC), by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24."|Baseline and wk 24||||mcg*wks/L||Full Range|Median
2639061|NCT01768013|Primary|Pharmacokinetic: AUClast of Calcipotriol|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined|Day 7||||h*pg/mL||Standard Deviation|Mean
2638775|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in 1,25 OHD, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48."|Baseline and wk 48||||pmol*wks/L||Full Range|Median
2638776|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in 1,25 OHD, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24."|Baseline and wk 24||||pmol*wks/L||Full Range|Median
2638777|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in FGF23, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48."|Baseline and wk 48||||pg*wks/mL||Full Range|Median
2638778|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in FGF23, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24."|Baseline and wk 24||||pg*wks/mL||Full Range|Median
2638779|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 24 in PTH, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, and 24."|Baseline and wk 24||||pg*wks/mL||Full Range|Median
2638780|NCT01769469|Secondary|Area Under the Drug Concentration by Time Curve (AUC): Change From Baseline to Week 48 in PTH, by Overall Drug Exposure|"Overall drug exposure categories were determined based on the overall tertiles of mean AUC dried blood spot (DBS) Red Blood Cell (RBC) Tenofovir Diphosphate (intracellular) (TFV-DP). Comparisons were performed between the high exposure group and the low exposure group.~The time points at which data were collected were: weeks 4, 8, 12, 24, 36, and 48."|Baseline and wk 48||||pg*wks/mL||Full Range|Median
2638781|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in CTX|"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]"|Baseline, Weeks (wks) 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||(pM)/ weeks||Full Range|Median
2638782|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Slope of the Curve of Baseline to Most Extreme Fold Change in OC|"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]"|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||(mcg/L)/ weeks||Full Range|Median
2638783|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Time to Most Extreme Fold Change in C-telopeptide (CTX)|The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||weeks||Full Range|Median
2638784|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: OC, Time to Most Extreme Fold Change|The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||weeks||Full Range|Median
2638785|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in C-telopeptide (CTX)|Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.|Baseline, Weeks 4, 8, 12, 24, 36 and 48|Subjects with at least two measurements available for comparison|||fold change||Full Range|Median
2638786|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Most Extreme Fold Change in Osteocalcin (OC)|Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.|Baseline, Weeks 4, 8, 12, 24, 36 and 48|Subjects with at least two measurements available for comparison|||fold change||Full Range|Median
2638787|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in C-Telopeptide (CTX)|CTX Week 48 difference from baseline|Baseline and wk 48|Subjects with data for baseline and Week 48|||pM||Full Range|Median
2638788|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Change From Baseline to Week 48 in Osteocalcin (OC)|OC Week 48 difference from baseline|Baseline and wk 48|Subjects with data for baseline and Week 48|||mcg/L||Full Range|Median
2638789|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in Scr|"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]"|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||(mg/dL)/ weeks||Full Range|Median
2638845|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Most Extreme Fold Change|Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.|Baseline, Weeks 4, 8, 12, 24, 36 and 48|Subjects with at least two measurements available for comparison|||fold change||Full Range|Median
2638791|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UProt/UCr|"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]"|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||Weeks^-1||Full Range|Median
2638792|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in UB2MG|"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]"|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||(ng/mL)/ weeks||Full Range|Median
2638793|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Slope of the Curve of Baseline to Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)|"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]"|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||(mcg/g)/ weeks||Full Range|Median
2638794|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UGluc|The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||weeks||Full Range|Median
2638795|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UProt/UCr|The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||weeks||Full Range|Median
2638796|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in UB2MG|The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||weeks||Full Range|Median
2638797|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Time to Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)|The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||weeks||Full Range|Median
2638798|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in SCr|Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.|Baseline, Weeks 4, 8, 12, 24, 36 and 48|Subjects with at least two measurements available for comparison|||fold change||Full Range|Median
2638799|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UGluc|Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.|Baseline, Weeks 4, 8, 12, 24, 36 and 48|Subjects with at least two measurements available for comparison|||fold change||Full Range|Median
2638800|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UProt/UCr|Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.|Baseline, Weeks 4, 8, 12, 24, 36 and 48|Subjects with at least two measurements available for comparison|||fold change||Full Range|Median
2638801|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in UB2MG|Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.|Baseline, Weeks 4, 8, 12, 24, 36 and 48|Subjects with at least two measurements available for comparison|||fold change||Full Range|Median
2638802|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Most Extreme Fold Change in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)|Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.|Baseline, Weeks 4, 8, 12, 24, 36 and 48|Subjects with at least two measurements available for comparison|||fold change||Full Range|Median
2638803|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Serum Creatinine (SCr)|The magnitude of change in SCr will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).|Baseline and wk 48|Subjects with data for baseline and Week 48|||fold change||Full Range|Median
2638804|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Glucose (UGluc)|The magnitude of change in UGluc will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).|Baseline and wk 48|Subjects with data for baseline and Week 48|||fold change||Full Range|Median
2638805|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Protein (UProt)/ Urine Creatinine (UCr)|The magnitude of change in UProt/UCr will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).|Baseline and wk 48|Subjects with data for baseline and Week 48|||fold change||Full Range|Median
2638806|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Beta-2 Microglobulin (UB2MG)|The magnitude of change in UB2MG will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).|Baseline and wk 48|Subjects with data for baseline and Week 48|||fold change||Full Range|Median
2638878|NCT01769443|Secondary|Incidence of Initiation of Any Mechanical Circulatory Support Device||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
2638807|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Magnitude of Fold Change at Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)|The magnitude of change in URBP/UCr will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).|Baseline and wk 48|Subjects with data for baseline and Week 48|||fold change||Full Range|Median
2638808|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Serum Creatinine (SCr)|SCr Week 48 difference from baseline|Baseline and wk 48|Subjects with data for baseline and Week 48|||mg/dL||Full Range|Median
2638809|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Glucose (UGluc)|UGluc Week 48 difference from baseline|Baseline and wk 48|Subjects with data for baseline and Week 48|||mg/dL||Full Range|Median
2638810|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Protein (UProt) / Urine Creatinine (UCr)|UProt/ UCr Week 48 difference from baseline|Baseline and wk 48|Subjects with data for baseline and Week 48|||ratio||Full Range|Median
2638811|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Beta-2 Microglobulin (UB2MG)|UB2MG Week 48 difference from baseline|Baseline and wk 48|Subjects with data for baseline and Week 48|||ng/mL||Full Range|Median
2638812|NCT01769469|Secondary|Change in Glomerular and Renal Tubular Function: Change From Baseline to Week 48 in Urine Retinol Binding Protein (URBP)/ Urine Creatinine (UCr)|URBP/UCr Week 48 difference from baseline|Baseline and wk 48|Subjects with data for baseline and Week 48|||mcg/g||Full Range|Median
2638813|NCT01769469|Secondary|Slope of the Curve of Baseline to Most Extreme Fold Change: SPO4|"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]"|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||(mmol/L)/ weeks||Full Range|Median
2638814|NCT01769469|Secondary|Time to Most Extreme Fold Change: SPO4|The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||weeks||Full Range|Median
2638815|NCT01769469|Secondary|Magnitude of Most Extreme Fold Change: SPO4|Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||fold change||Full Range|Median
2638816|NCT01769469|Secondary|Change From Baseline to Week 48 in Serum Phosphate (SPO4)|Serum Phosphate (SPO4) Week 48 difference from baseline|Baseline and wk 48|Subjects with data for baseline and Week 48|||mmol/L||Full Range|Median
2638817|NCT01769469|Secondary|Slope of the Curve of Baseline to Most Extreme Fold Change: UCa/UCr Ratio|"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]"|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||(mg/mg)/ weeks||Full Range|Median
2638818|NCT01769469|Secondary|Time to Most Extreme Fold Change: UCa/UCr Ratio|The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||weeks||Full Range|Median
2638819|NCT01769469|Secondary|Magnitude of Most Extreme Fold Change: UCa/UCr Ratio|Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||fold change||Full Range|Median
2638820|NCT01769469|Secondary|Change From Baseline to Week 48 in Urine Calcium (UCa) / Urine Creatinine (UCr)|Urine Calcium (UCa) / Urine Creatinine (UCr) ratio Week 48 difference from baseline|Baseline and wk 48|Subjects with data for baseline and Week 48|||ratio||Full Range|Median
2638821|NCT01769469|Secondary|Slope of the Curve of Baseline to Most Extreme Fold Change: Serum Calcium (SCa)|"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]"|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||(mg/dL)/ weeks||Full Range|Median
2638822|NCT01769469|Secondary|Time to Most Extreme Fold Change: Serum Calcium (SCa)|The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||weeks||Full Range|Median
2638823|NCT01769469|Secondary|Magnitude of Most Extreme Fold Change: Serum Calcium (SCa)|Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with data available for at least two time points|||fold change||Full Range|Median
2638824|NCT01769469|Secondary|Change From Baseline to Week 48 in Serum Calcium (SCa)|Serum calcium Week 48 difference from baseline|Baseline and wk 48|Subjects with data for baseline and Week 48|||mg/dL||Full Range|Median
2638825|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Slope of the Curve of Baseline to Most Extreme Fold Change|"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]"|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||(% phosphorus reabsorbed)/ weeks||Full Range|Median
2638826|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25-OHD, Slope of the Curve of Baseline to Most Extreme Fold Change|"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]"|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||(pmol/L)/ weeks||Full Range|Median
2638827|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: FGF23, Slope of the Curve of Baseline to Most Extreme Fold Change|"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]"|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||(pg/mL)/ weeks||Full Range|Median
2638828|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Slope of the Curve of Baseline to Most Extreme Fold Change|"The slope from baseline to most extreme fold change can be expressed as:~Slope = [(Most extreme fold change) * (baseline value) - (baseline value)] / [(Time to most extreme fold change) - (time of the baseline value)]"|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||(pg/mL)/ weeks||Full Range|Median
2638829|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Serum Creatinine (SCr), Time to Most Extreme Fold Change|The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||weeks||Full Range|Median
2638830|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Time to Most Extreme Fold Change|The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||weeks||Full Range|Median
2638831|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: PTH, Most Extreme Fold Change|Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.|Baseline, Weeks 4, 8, 12, 24, 36 and 48|Subjects with at least two measurements available for comparison|||fold change||Full Range|Median
2638832|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Time to Most Extreme Fold Change|The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||weeks||Full Range|Median
2638833|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Most Extreme Fold Change|Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.|Baseline, Weeks 4, 8, 12, 24, 36 and 48|Subjects with at least two measurements available for comparison|||fold change||Full Range|Median
2638834|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: GFR, Magnitude of Fold Change|The magnitude of change in GFR will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).|Baseline and wk 48|Subjects with data for baseline and Week 48|||fold change||Full Range|Median
2638835|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Glomerular Filtration Rate (GFR), Change From Baseline to Week 48||Baseline and wk 48|Subjects with data for baseline and Week 48|||ml/min/1.73m^2||Full Range|Median
2638836|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Time to Most Extreme Fold Change|The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||weeks||Full Range|Median
2638837|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Most Extreme Fold Change|Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.|Baseline, Weeks 4, 8, 12, 24, 36 and 48|Subjects with at least two measurements available for comparison|||fold change||Full Range|Median
2638838|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: TRP, Magnitude of Fold Change|The magnitude of change in TRP will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).|Baseline and wk 48|Subjects with data for baseline and Week 48|||fold change||Full Range|Median
2638839|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Tubular Reabsorption of Phosphate (TRP), Change From Baseline to Week 48||Baseline and wk 48|Subjects with data for baseline and Week 48|||percentage of phosphorus reabsorbed||Full Range|Median
2638840|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Time to Most Extreme Fold Change|The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||weeks||Full Range|Median
2638841|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Most Extreme Fold Change|Most extreme fold change: This is the highest or lowest value measured as fold change from the baseline value of that variable.|Baseline, Weeks 4, 8, 12, 24, 36 and 48|Subjects with at least two measurements available for comparison|||fold change||Full Range|Median
2638842|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 OHD, Magnitude of Fold Change|The magnitude of change in 1,25 OHD will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).|Baseline and wk 48|Subjects with data for baseline and Week 48|||fold change||Full Range|Median
2638843|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: 1,25 Dihydroxy Vitamin D (1,25 OHD), Change From Baseline to Week 48||Baseline and wk 48|Subjects with data for baseline and Week 48|||pmol/L||Full Range|Median
2638844|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Time to Most Extreme Fold Change|The time to most extreme fold change is the study week associated with the most extreme fold change or extreme percent change from baseline.|Baseline, Weeks 4, 8, 12, 24, 36, and 48|Subjects with at least two measurements available for comparison|||weeks||Full Range|Median
2638846|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Magnitude of Fold Change|The magnitude of change in FGF23 will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).|Baseline and wk 48|Subjects with data for baseline and Week 48|||fold change||Full Range|Median
2638847|NCT01769469|Secondary|Change in Renal-endocrine-bone Biochemistry and Pathophysiology: Fibroblast Growth Factor 23 (FGF23), Change From Baseline to Week 48||Baseline and wk 48|Subjects with data for baseline and Week 48|||pg/ML||Full Range|Median
2638848|NCT01769469|Primary|Magnitude of Change (Fold Change) in Parathyroid Hormone (PTH) From Baseline to Week 48|The magnitude of change in PTH will be measured between Baseline and Week 48. For any given variable, at a given time point, the magnitude of change is the fold change compared to the baseline value (if multiplied by 100 would be the percent change from baseline).|Baseline and Week (wk) 48|Subjects with PTH data at baseline and Week 48|||fold change||Full Range|Median
2638849|NCT01769456|Secondary|Demographic and/or Behavioral Differences Between Youth Who Are Interested in Participating in a PrEP Study Versus Those Who Are Not.|Behavioral disinhibition/risk compensation endpoints will be compared.|48 weeks|Data were not collected.||||||
2638850|NCT01769456|Secondary|Evaluation of the Process of Protocol Implementation|"Brief phone interviews and review of written institutional review board (IRB) correspondence will be conducted for all sites whether the study is approved at that site or not. If approved, the steps needed for approval and how barriers were addressed will be examined. If the study was rejected, the reasons for disapproval, the IRB's interpretation of the risk of PrEP, and other barriers will be examined. In addition, data from a survey specific to each site's IRB's responses of minor YMSM inclusion in PrEP studies will be evaluated.~NOTE: Data collected to address this outcome were primarily qualitative in nature, and as such are not presented here. For more information on this outcome, refer to:~Gilbert AL, Knopf AS, Fortenberry JD, Hosek SG, Kapogiannis BG, Zimet GD. Adolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research. J Adolesc Health. 2015 Jul;57(1):113-9."|48 weeks|Quantitative data were not collected for this outcome.||||||
2638851|NCT01769456|Secondary|Demographic and/or Behavioral Difference Between Study Groups. Behavioral Disinhibition/Risk Compensation Endpoints Will be Compared.||48 weeks|Data were not collected.||||||
2638852|NCT01769456|Secondary|Rating of the Reasons for Missing Medications on a 4-point Likert Scale.|"This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders, as measured by subject rating of the reasons for missing medications on a 4-point Likert scale.~Subjects were asked to rate various measures as Never, Rarely, Sometimes, or Often the reason for missing taking study pills. Data shown for Week 48.~Question: In the past month, how often have you missed taking your study pills because you:"|48 weeks|Enrolled subjects with a Week 48 visit; individual rows may have varying Ns due to the number of subjects providing data for each question.|||Participants|||Count of Participants
2638853|NCT01769456|Secondary|Number of Participants Using Text Messaging Reminders|This represents one of the indicators associated with the objective: Acceptability and feasibility of text message reminders.|Baseline through Week 48|The analysis population for those discontinued is the population (N=22) of those who initially signed up to receive reminders.|||Participants|||Count of Participants
2638854|NCT01769456|Secondary|Acceptability and Feasibility of Two Types of Efficacious Sexual Risk Reduction Interventions as Measured by Session Evaluation|Study subjects were given a brief Session Evaluation Form at the end of the behavioral intervention session consisting of ten items on a 4-point response scale aimed at eliciting information about the subject's experience with the session (i.e., was session interesting, was it relevant to their life, and did they learn from the session)|48 weeks|Data not collected; only one type of risk reduction intervention was ultimately implemented.||||||
2638855|NCT01769456|Primary|Estimation of Medication Adherence by Dried Blood Spot (DBS) Results|"This outcome addresses the objective: Rates of adherence and measured levels of drug exposure when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies.~Medication adherence is estimated by factors including levels of drug exposure as measured by DBS red blood cell (RBC) samples.~The TFV dosing level was translated into number of dosing days per week for week 8 onwards using lab estimates as follows: '<2 days' is defined as <350 (fmol/punch), '2 days' as 350 to 700 (fmol/punch), '4 days' as >700 to 1250 (fmol/punch), and 'Daily' as >1250 (fmol/punch).~The TFV dosing level was translated into number of dosing days for week 4 using lab estimates as follows: '<2 days' is defined as <275 (fmol/punch), '2 days' as 275 to 525 (fmol/punch), '4 days' as >525 to 950 (fmol/punch),and 'Daily' as >950 (fmol/punch)"|Week 4, Week 12, Week 24, Week 36, Week 48|Number analyzed in each row varies based on the number of enrolled subjects with DBS data available for each week.|||Participants|||Count of Participants
2638856|NCT01769456|Primary|Acceptability of PrEP Regimen and Study Visits|"This represents one of the indicators associated with the objective: Acceptability when YMSM are provided open label FTC/TDF (Truvada®) and information regarding the safety and efficacy of PrEP from prior studies.~Acceptability of PrEP as measured by the acceptability assessment that includes questions on usability of PrEP, user-friendliness of the medication regimen, including an assessment of side effects and delivery format, and acceptability of behavioral intervention sessions."|Week 12|Enrolled subjects with Week 12 data (individual row totals vary based on number of subjects providing responses for each question)|||Participants|||Count of Participants
2638857|NCT01769456|Primary|Behavioral Disinhibition/Risk Compensation: Number of Male Sexual Partners|"Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to related to number of male sexual partners from the participant ACASI:~Since the last time you took this survey, how many male partners have you had sexual contact with (oral or anal)?~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM."|Week 48|Participants providing data for this question at Week 48.|||male sexual partners||Standard Deviation|Mean
2638879|NCT01769443|Secondary|Incidence of Removal From Transplant Waiting List for Any Reason Except Improvement of Cardiac Function||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
2638858|NCT01769456|Primary|Behavioral Disinhibition/Risk Compensation: Number of Participants Reporting Unprotected Sex|"Behavioral disinhibition/risk compensation was assessed based on a number of questions, including the following related to unprotected sex from the participant ACASI:~Of these males [male partners], how many did you have unprotected oral or anal sex with since the last time you took this survey? An event is defined as an answer of greater than 0.~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM."|Week 48|Participants providing data for this question at Week 48.|||Participants|||Count of Participants
2638859|NCT01769456|Primary|Number of Participants With Decrease in Bone Mineral Density|"The proportion of subjects with DXA data through Week 48 who experienced varying degrees of decrease in absolute BMD in at least one region (spine, hip, or whole body).~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM."|48 weeks|Enrolled subjects with DXA results for baseline and Week 48|||Participants|||Count of Participants
2638860|NCT01769456|Primary|Total Hip Bone Mineral Density: Percent Change From Baseline to Week 48|"The percent change in total hip BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM."|Baseline, Week 48|Subjects with DXA data at both baseline and Week 48.|||percent change||Standard Deviation|Mean
2638861|NCT01769456|Primary|Total Body Bone Mineral Density: Percent Change From Baseline to Week 48|"The percent change in total body BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM."|Baseline, Week 48|Subjects with DXA data at both baseline and Week 48.|||percent change||Standard Deviation|Mean
2638862|NCT01769456|Primary|Femoral Neck Bone Mineral Density: Percent Change From Baseline to Week 48|"The percent change in femoral neck BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM."|Baseline, Week 48|Subjects with DXA data at both baseline and Week 48.|||percent change||Standard Deviation|Mean
2638863|NCT01769456|Primary|Lumbar Spine Bone Mineral Density: Percent Change From Baseline to Week 48|"The percent change in lumbar spine BMD from baseline measurement to Week 48 is calculated as:~Percent change= [(Value at Week 48 - Value at Baseline)/(Value at Baseline)] x 100~This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM."|Baseline, Week 48|Subjects with dual energy x-ray absorptiometry (DXA) data at both baseline and Week 48.|||percent change||Standard Deviation|Mean
2638864|NCT01769456|Primary|Number of Participants With Serum Creatinine Event of Grade 1 or Higher Over the Course of the Study|"This represents one of the indicators associated with the objective: Additional safety data regarding FTC/TDF (Truvada®) use among HIV-uninfected YMSM.~Participants were assessed for any serum creatinine event of Grade 1 or higher over the course of the study (Week 0 through Week 48)."|48 weeks||||Participants|||Count of Participants
2638865|NCT01769443|Secondary|Incidence of Rejection Episodes Per Subject and Freedom From Rejection|"Rejection is defined as follows:~Biopsy proven acute rejection (BPAR) of any grade (cellular rejection per 2004 ISHLT [International Society of Heart and Lung Transplantation] grading scale),~BPAR (individual grades),~BPAR (Biopsy Proven Acute Rejection) > 2R~antibody mediated rejection (AMR),~Any treated rejection,~Rejection associated with hemodynamic compromise (HDC)."|24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.||||||
2638866|NCT01769443|Secondary|Incidence of Hospitalizations||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.||||||
2638867|NCT01769443|Secondary|Re-transplantation or Re-listed for Transplantation||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.||||||
2638868|NCT01769443|Secondary|Death||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.||||||
2638869|NCT01769443|Secondary|Incidence of Post-Transplant Lymphoproliferative Disorder (PTLD)||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.||||||
2638870|NCT01769443|Secondary|Cardiac Dysfunction as Reflected in the Left Ventricular Ejection Fractions < 40% by Echocardiography, Angiogram or Nuclear Testing.||24 and 52 weeks:|No analyses were performed due to slow enrollment and early study closure.||||||
2638871|NCT01769443|Secondary|Number of Subjects on Left Ventricular Assist Devices (LVAD) Compared to Those Not on LVADs||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.||||||
2638872|NCT01769443|Secondary|Incidence of Serious Infections Requiring Intravenous Antimicrobial Therapy||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.||||||
2638873|NCT01769443|Secondary|Development of Angiographically Evident Cardiac Allograft Vasculopathy at 1 Year||24 and 52 weeks post-transplantation|No analyses were performed due to slow enrollment and early study closure.||||||
2638874|NCT01769443|Secondary|Incidence of Administering Desensitization Therapy Beyond 90 Days After Randomization||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
2638875|NCT01769443|Secondary|Incidence of Acute Renal Failure Requiring Hemodialysis||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
2638876|NCT01769443|Secondary|Incidence of Cerebral Vascular Accident||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
2638877|NCT01769443|Secondary|Incidence of Severe Infection Requiring Intravenous Antibiotics||At transplant, or 1 year post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
2639610|NCT01763866|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2638883|NCT01769443|Primary|Composite of Incidence of the Following Events in Subjects|"Death,~Removal from the transplant waiting list for any reason except improvement of cardiac function,~Initiation of any mechanical circulatory support device,~Severe infection requiring intravenous antibiotics,~Cerebral vascular accident,~Acute renal failure requiring dialysis."|At transplant, or 90 days post-randomization, whichever occurs first|No analyses were performed due to slow enrollment and early study closure.||||||
2638884|NCT01769404|Secondary|Concentration of Norepinephrine|Norepinephrine values are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value.|30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp|All participants in Cohort 2 who received at least 1 dose of study drug with evaluable norepinephrine data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.|||pmol/L||Standard Deviation|Mean
2638885|NCT01769404|Secondary|Concentration of Growth Hormone|Growth hormone levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.|30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp|All participants in Cohort 2 who received at least 1 dose of study drug with evaluable growth hormone data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.|||micrograms per liter (µg/L)||Standard Deviation|Mean
2638886|NCT01769404|Secondary|Concentration of Glucagon|Glucagon levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.|30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp|All participants in Cohort 2 who received at least 1 dose of study drug with evaluable glucagon data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.|||pmol/L||Standard Deviation|Mean
2638887|NCT01769404|Secondary|Concentration of Cortisol|Cortisol levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at BG level attainment and +30 minutes were averaged for the BG nadir value.|30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp|All participants in Cohort 2 who received at least 1 dose of study drug with evaluable cortisol data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.|||nanomole per liter (nmol/L)||Standard Deviation|Mean
2638888|NCT01769404|Secondary|Amount of Glucose Required to Maintain BG of 72 mg/dL|The amount of infused glucose required to maintain BG of 72 mg/dL for 1 hour is presented.|30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp|All participants in Cohort 2 who received at least 1 dose of study drug with evaluable BG data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.|||mg||Geometric Coefficient of Variation|Geometric Mean
2638889|NCT01769404|Secondary|Amount of Glucose Required to Reach Blood Glucose (BG) of 72 mg/dL|The amount of infused glucose required to reach BG of 72 milligrams per deciliter (mg/dL) is presented.|30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp|All participants in Cohort 2 who received at least 1 dose of study drug with evaluable BG data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.|||milligrams (mg)||Geometric Coefficient of Variation|Geometric Mean
2638890|NCT01769404|Primary|Concentration of Epinephrine|Epinephrine levels are presented. Each participant's measurements at 30, 15, and 0 minutes preclamp on the day of the clamp were averaged for the baseline value, and measurements at blood glucose (BG) level attainment and +10, 20, and 30 minutes were averaged for the BG nadir value.|30, 15, and 0 minutes Preclamp; 10, 20, and 30 minutes Post-Clamp|All participants in Cohort 2 who received at least 1 dose of study drug with evaluable epinephrine data. As per protocol amendment, no participants in cohort 1 were analyzed and only cohort 2 participants were analyzed for efficacy.|||picomole per liter (pmol/L)||Standard Deviation|Mean
2638891|NCT01769391|Secondary|Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab||Cycle 1, Day 8 ; Cycle 2, Day 1; Cycle 3, Day 1;Cycle 4, Day1;Cycle 5, Day 1; Cycle 6, Day 1 (within 2 hours prior to beginning of infusion)|All participants who received at least one dose of study drug and had evaluable PK data.|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2638892|NCT01769391|Secondary|Percent Change in Tumor Size (CTS)|CTS is defined as maximum percent change from baseline in the sum of target lesions.|Baseline to Progressive Disease or Death (Up to 24 Months)|All randomized participants who received at least 1 dose of study drug and who had a decrease from baseline in the sum of target lesions.|||percent change in tumor size||Standard Deviation|Mean
2638893|NCT01769391|Secondary|Percentage of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])|Defined using the same denominator as defined in ORR. Among participants counted in the denominator, the numerator counts those with a confirmed best tumor response of SD, PR, or CR per RECIST 1.1. (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PR at least 30% decrease in the sum of diameter of target lesions; CR: disappearance of all target lesions).|Baseline to Progressive Disease and/or Death (Estimated up to 24 Months)|All randomized participants who received at least 1 dose of study drug and who had a complete radiographic assessment.|||percentage of participants||95% Confidence Interval|Number
2638922|NCT01769339|Secondary|Pruritus Symptom Assessment by Visual Analog Scale (VAS) Score|Pruritus is assessed by using a 100 millimeter (mm) of VAS score ranges from 0 to 100 mm, where 0 mm=no pruritus and 100 mm=worse pruritus.|1-hour after initial application|Data was not collected as only few participants had pruritus after 1-hour of study drug application.||||||
2638923|NCT01769339|Secondary|Modified Itch Severity Scale (MISS) Score|The MISS is a specific instrument for assessing and quantifying the intensity of pruritus. The MISS score ranges from 0 to 21, where 0=no itching and 21=very severe itching.|Baseline and Day 28|Analysis Population included all the participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants who were evaluable at specified time-point.|||units on a scale||Standard Deviation|Mean
2638894|NCT01769391|Secondary|Progression-Free Survival|Progression-Free Survival (PFS) is defined as the time from randomization until the first radiographically documented progressive disease (PD) or death from any cause. PD defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST version 1.1) as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last complete radiographic assessment.|Randomization to Progressive Disease or Death (Up to 24 Months)|All randomized participants; with 15 and 7 censored participants in Paclitaxel +Carboplatin + Necitumumab and Paclitaxel +Carboplatin Arms, respectively.|||months||95% Confidence Interval|Median
2638895|NCT01769391|Secondary|Percentage of Participants With Anti Necitumumab Antibodies||Baseline to End of Cycle 6|All participants who received any amount of necitumumab and had post baseline antibody data.|||percentage of participants|||Number
2638896|NCT01769391|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab||Pre-infusion Cycle 1, Day 1; Cycle 3, Day 1; Cycle 5; Day 1 (within 2 hours prior to beginning of infusion)|All participants who received at least one dose of necitumumab and had evaluable PK data.|||microgram/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2638897|NCT01769391|Secondary|Overall Survival (OS)|OS defined as the time from the date of randomization to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS was censored at the last contact date (last contact for participants in post-discontinuation = last known alive date in mortality status).|Randomization to Date of Death (Up to 24 Months)|All randomized participants; (49 and 19 censored participants in Paclitaxel + Carboplatin + Necitumumab and Paclitaxel + Carboplatin Arms, respectively.|||months||95% Confidence Interval|Median
2638898|NCT01769391|Primary|Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])|The denominator of ORR (Objective Response Rate) includes each participant enrolled who received any amount of study drug (necitumumab, gemcitabine, and/or cisplatin), and who had a complete radiographic assessment at baseline and at least one complete radiographic assessment post-baseline. The numerator includes those participants counted in the denominator with a confirmed best overall tumor response of partial or complete response (Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.|Baseline to Disease Progression or Death (Up to 24 Months)|All randomized participants that received at least 1 dose of study drug, who had a complete radiographic assessment at baseline and at least 1 complete radiographic assessment post-baseline.|||percentage of participants||95% Confidence Interval|Number
2638899|NCT01769378|Secondary|Change From Baseline in Amylase|A summary of changes in amylase evaluation from baseline to endpoint.|Baseline, 24 Weeks|Participants who received at least one dose of study drug and had evaluable amylase data at both baseline and post-baseline. LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.|||Units/Liter||Inter-Quartile Range|Median
2638900|NCT01769378|Secondary|Change From Baseline in Lipase|A summary of changes in lipase evaluation from baseline to endpoint.|Baseline, 24 Weeks|All participants who received at least one dose of study drug and had evaluable lipase data at both baseline and post-baseline. LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.|||Units/Liter||Inter-Quartile Range|Median
2638901|NCT01769378|Secondary|Dulaglutide Anti-Drug Antibodies (ADA)|Number of participants with treatment emergent (TE) dulaglutide anti-drug antibodies from postbaseline to follow up were summarized. A participant is considered to have TE dulaglutide ADA if the participant has at least one titer that is treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline up to 4 Weeks Post-Last Dose of Study Drug|ITT population: all randomized participants who received at least one dose of study drug.|||participants|||Number
2638902|NCT01769378|Secondary|Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia|An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period.|Baseline through 24 Weeks|ITT population: All randomized participants who received at least one dose of study drug.|||weeks||Standard Error|Mean
2638903|NCT01769378|Secondary|Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia|Additional Intervention: any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.|Baseline through 24 Weeks|ITT population: all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
2638904|NCT01769378|Secondary|Rate of HE Adjusted Per 30 Days|The hypoglycemia rate per 30 days during defined period is calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days.|Baseline through 24 weeks|ITT population: all randomized participants who received at least one dose of study drug.|||number of events/participants/30 days||Standard Deviation|Mean
2638924|NCT01769339|Secondary|Percentage of Participants Who Achieved Clinical Cure|Participants were considered as clinically cured if the potassium hydroxide (KOH) mount / Gram stain (a method used to diagnose bacterial infection) test was negative for infection.|Baseline up to Day 28|Analysis population included all the participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
2652090|NCT01656252|Secondary|Phase II- Time to Platelet Count Recovery|To determine the impact of eltrombopag on time to platelet recovery following consolidation chemotherapy.|62 months|||||||
2638905|NCT01769378|Secondary|Percentage of Participants With Self-Reported Events of Hypoglycemia|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of =<3.9 mmol/L), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of =<3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). Percentage is calculated as the number of participants reporting HE each visit/ the total number of participants reporting HE during the entire study treatment period.|Baseline through 24 Weeks|ITT Population: all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
2638906|NCT01769378|Secondary|Change From Baseline in Calcitonin at 24 Weeks||Baseline, 24 Weeks|Participants who received at least one dose of study drug and evaluable calcitonin data at baseline and post-baseline.|||picogram per milliliter (pg/ml)||Inter-Quartile Range|Median
2638907|NCT01769378|Secondary|Number of Participants With Adjudicated Acute Pancreatitis Events|The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 24 Weeks, 30-day Follow Up|ITT population: all randomized participants who received at least one dose of study drug.|||participants|||Number
2638908|NCT01769378|Secondary|Number of Participants With Reported and Adjudicated Cardiovascular Events|Information on cardiovascular (CV) risk factors was collected at baseline. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 24 weeks plus 30-day follow up. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.|Baseline through 24 Weeks, 30-day Follow Up|ITT population: All randomized participants who received at least one dose of study drug.|||participants|||Number
2638909|NCT01769378|Secondary|Change From Baseline in Mean of All 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks|LS Means of the SMPG change from baseline to primary endpoint at week 24 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline SMPG value as covariate, via a MMRM analysis using REML.|Baseline, 24 Weeks|Participants who received at least one dose of study drug and had evaluable SMPG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2638910|NCT01769378|Secondary|Change From Baseline in Body Mass Index (BMI) at 24 Weeks|LS Means of the BMI change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline BMI as covariate, via a MMRM analysis using REML.|Baseline, 24 Weeks|Participants who received at least one dose of study drug and evaluable BMI data at both baseline and post-baseline.|||kilograms per/square meter kg/m^2||Standard Error|Least Squares Mean
2638911|NCT01769378|Secondary|Change From Baseline in Body Weight at 24 Weeks|LS Means of the body weight change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline body weight as covariate, via a MMRM analysis using REML.|Baseline, 24 Weeks|Participants who received at least one dose of study drug and had evaluable body weight data at both baseline and post-baseline.|||kilograms (kg)||Standard Error|Least Squares Mean
2638912|NCT01769378|Secondary|Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks|LS Means of the FSG from baseline to primary endpoint was adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline FSG as covariate, via Analysis of Covariance Model (ANCOVA) with Last Observation Carried Forward (LOCF).|Baseline, 24 Weeks|Participants who received at least one dose of study drug and had evaluable FSG data at both baseline and post-baseline. LOCF was used to impute missing post-baseline values. If no data after date of randomization, the endpoint was considered missing.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2638913|NCT01769378|Secondary|Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks|The percentage of participants who achieved the target HbA1c values at endpoint will be analyzed with a repeated logistic regression model (the generalized estimation equation [GEE] model). The model includes country, treatment, visit and treatment interaction and baseline HbA1c as a continuous covariate.|24 Weeks|Participants who were randomized and received at least one dose of study drug with evaluable HbA1c data.|||percentage of participants|||Number
2638914|NCT01769378|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks|Least Squares Means (LS Means) of the HbA1c change from baseline to primary endpoint was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect and baseline HbA1c as covariate, via a Mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML).|Baseline, 24 Weeks|Participants who were randomized and received at least one dose of study drug with evaluable HbA1c data at both baseline and post-baseline.|||percent change of HbA1c||Standard Error|Least Squares Mean
2638915|NCT01769365|Primary|Number of Participants With Complete Eradication of Helicobacter Pylori|Evaluate eradication outcome by endoscopy urease test and histology or urea breath test|at the 6th week after the end of anti- H. pylori therapy||||participants|||Number
2638916|NCT01769352|Secondary|Mean Change in Intraocular Pressure Between Week 12 and Week 24|Mean Change in Intraocular Pressure (IOP) between week 12 and week 24|Week 12 and Week 48||||mmHg||Standard Error|Mean
2638917|NCT01769352|Secondary|Mean Change in Central Subfield Thickness (CST) Between Week 12 and Week 48|Mean Change in Central Subfield Thickness (CST,µm) between week 12 and week 48|Week 12 and Week 48||||µm||Standard Error|Mean
2638925|NCT01769339|Primary|Mean Time to Itch Relief|Time to itch relief is defined as time needed to achieve pruritus (itchiness) relief.|1-hour after initial application|Analysis population included all the participants who received at least 1 dose of study medication.|||minutes||Standard Error|Mean
2638927|NCT01769326|Primary|Motor and Strength Outcome Measure Using Fugl-Meyer Score|The primary outcome measure was the change in Upper Extremity FM score on a scale of 0 to 66 at one month post therapy. The higher the scores, the better arm and hand function indicated.|From baseline to 1 month post therapy|Fugl-Meyer score at one month post therapy minus Fugl-Meyer score at baseline on a 66 point scale. Please note that Fugl-Meyer UE motor score is the primary outcome measure for RAE part of the study.|||units on a scale||Standard Deviation|Mean
2638928|NCT01769326|Primary|Motor and Strength Outcome Measure Using Box and Block Test|The primary end point was the change in Box and Blocks score, which measures how many blocks a subject can pick up and place in a box in 60 secons, from baseline to 1 month posttherapy. The higher the scores, the better arm and hand function indicated.|From baseline to 1 month post therapy|Number of blocks participants able to pick up and place in a box in 60 seconds at one month follow up minus the number of blocks participants able to pick up and place in a box in 60 seconds at baseline. Please note that box and block test was the primary outcome measure for the Music Glove part of the study.|||blocks||Standard Deviation|Mean
2638929|NCT01769274|Secondary|Number of Participants With Clinically Significant Changes From Baseline in Electrocardiogram (ECG)|Criteria for clinically significant abnormalities in ECG : PR interval >=300 millisecond (msec) and 25 percent (%) increase when baseline >200 msec, 50% increase when baseline less than or equal to (<=) 200 msec; QRS interval >=140 msec, >=50% increase from baseline; QT interval >=500 msec; QT interval corrected using the Fridericia formula (QTcF) 450 msec to <480 msec, >=480 msec, 30 to <60 msec increase from baseline, >=60 msec increase from baseline.|Baseline up to a maximum of Day 83|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2638930|NCT01769274|Secondary|Number of Participants With Clinically Significant Changes From Baseline in Blood Pressure|Criteria for clinically significant blood pressure abnormalities: systolic blood pressure >=30 millimetre of Mercury (mmHg) change from baseline in same posture, systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline in same posture, diastolic blood pressure <50 mmHg.|Baseline up to a maximum of Day 83|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2638931|NCT01769274|Secondary|Number of Participants With Clinically Significant Changes From Baseline in Core Body Temperature|The minimum starting temperature to measure core body temperature used was 33 degree Celsius. Clinically significant changes from baseline in core body temperature was judged by investigator.|Baseline up to a maximum of Day 83|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2638932|NCT01769274|Secondary|Number of Participants With Laboratory Abnormalities|Laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell count: less than(<)0.8*lower limit of normal(LLN), platelet: <0.5*LLN/greater than (>)1.75*upper limit of normal (ULN), white blood cell: <0.6*LLN/>1.5*ULN, lymphocyte, neutrophil (absolute, %):<0.8*LLN/>1.2*ULN, total neutrophil <0.8*LLN;basophil, eosinophil, monocyte (absolute, %):>1.2*ULN; mean corpuscular (MC) volume, mean cell hemoglobin, MC hemoglobin concentration, mean platelet volume: <0.9*LLN/>1.1*ULN; total bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:> 3.0*ULN, total protein, albumin: <0.8*LLN/>1.2*ULN; blood urea nitrogen, creatinine:>1.3*ULN, uric acid >1.2*ULN; sodium <0.95*LLN/>1.05*ULN, potassium, chloride, calcium, magnesium, bicarbonate: <0.9*LLN/>1.1*ULN; glucose <0.6*LLN/>1.5*ULN; urine (specific gravity <1.003/>1.030, pH <4.5/>8, glucose, ketone, protein, blood/Hgb, urobilinogen, bilirubin, nitrite, leukocyte esterase >=1).|Baseline up to a maximum of Day 73|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2638933|NCT01769274|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state.|Baseline up to a maximum of Day 83|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2638934|NCT01769274|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05089771||Predose and 0.5, 2, 4, 6, and 24 hours post dose|PK parameter analysis set included all participants who were randomized, received study medication, and had at least 1 of the PK parameters of interest in at least 1 treatment session.|||Hours||Full Range|Median
2638935|NCT01769274|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05089771||Predose and 0.5, 2, 4, 6, and 24 hours post dose|PK parameter analysis set included all participants who were randomized, received study medication, and had at least 1 of the PK parameters of interest in at least 1 treatment session.|||Nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2638936|NCT01769274|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05089771||Predose and 0.5, 2, 4, 6, and 24 hours post dose|PK parameter analysis set included all participants who were randomized, received study medication, and had at least 1 of the PK parameters of interest in at least 1 treatment session.|||Nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2638937|NCT01769274|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to the 24 Hour Post-dose (AUC24) of PF-05089771||Predose, 0.5, 2, 4, 6, and 24 hours post-dose|Pharmacokinetic (PK) parameter analysis set included all participants who were randomized, received study medication, and had at least 1 of the PK parameters of interest in at least 1 treatment session.|||Nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2638947|NCT01769274|Secondary|Maximum PI-NRS Scores - From 0 Hour to 4 Hours Post-dose|Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Maximum pain score in 4 hours period post-dosing is reported.|From 0 hour to 4 hours post-dose|Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication.|||Units on a scale||Standard Deviation|Mean
2638938|NCT01769274|Secondary|Time to First Use of Rescue Therapy or Medication|Time to rescue medication (hour) was calculated as: date/time of rescue medication minus date/time of first dose for each period. If participant who did not receive rescue medication, the time of censoring was cut off at 24 hours or the time of withdrawal, whichever was earlier. Kaplan-Meier method was used for estimation.|Up to maximum of 24 hours post-dose|Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Number of Participants Analyzed = number of participants evaluable for this outcome measure.|||Hours||90% Confidence Interval|Mean
2638939|NCT01769274|Secondary|Number of Participants With Participant's Global Satisfaction Score|"Participant was asked How would you rate the study medication you received for pain?. The participant was provided the following choices as an answer: excellent=4; good=3; fair=2; poor=1. Response to this question, was participant's overall impression (global evaluation) of the study medication at 4 hour post-dose or at time of first rescue treatment or medication, which ever occurred first."|At 4 hour post-dose or at time of first rescue therapy, whichever occurred first|Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication.|||Participants|||Count of Participants
2638940|NCT01769274|Secondary|Duration When PI-NRS Scores Were >5 - From Post EP4 to 28 Hours Post-dose|Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 4= third time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP4 is approximately a time point 24-25 hours post-dose. The duration of time that participants experienced PI-NRS score >5 from post EP4 to 28 hours post-dose.|After EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose|"Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure."|||Minutes||Standard Deviation|Mean
2638941|NCT01769274|Secondary|Duration When PI-NRS Scores Were >5 - From Post EP3 to 10 Hours Post-dose|Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 3= second time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP3 is approximately a time point 8-9 hours post-dose. The duration of time that participants experienced PI-NRS score >5 from the post EP3 to 10 hours post dose.|Post EP3, every 5 minutes for the first hour, then every 15 minutes up to 10 hours post-dose|"Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure."|||Minutes||Standard Deviation|Mean
2638942|NCT01769274|Secondary|Duration When PI-NRS Scores Were >5 - From Post EP2 to 8 Hours Post-dose|Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 2= first time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP2 is approximately a time point 4-5 hours post-dose. The duration of time that participants experienced PI-NRS score >5 from in period from post EP2 to 8 hours post-dose is reported.|Post EP2, every 5 minutes for the first hour, then every 15 minutes up to 8 hours post-dose|"Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure."|||Minutes||Standard Deviation|Mean
2638943|NCT01769274|Secondary|Duration When PI-NRS Scores Were Greater Than (>) 5 - From 0 Hour to 4 Hours Post-dose|Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. The duration of time that participants experienced PI-NRS score greater than 5 from the 0 hours to 4 hours post-dose.|From 0 hour to 4 hours post-dose|Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication.|||Minutes||Standard Deviation|Mean
2638944|NCT01769274|Secondary|Maximum PI-NRS Scores - From Post EP4 to 28 Hours Post-dose|Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 4= third time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP4 is approximately a time point 24-25 hours post-dose. Maximum pain score in period from post EP4 to 28 hours post-dose is reported.|Post EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose|"Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure."|||Units on a scale||Standard Deviation|Mean
2638945|NCT01769274|Secondary|Maximum PI-NRS Scores - From Post EP3 to 10 Hours Post-dose|Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 3= second time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP3 is approximately a time point 8-9 hours post-dose. Maximum pain score in period from post EP3 to 10 hours post-dose is reported.|From the end of EP3 to 10 hours post dose|"Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure."|||Units on a scale||Standard Deviation|Mean
2638946|NCT01769274|Secondary|Maximum PI-NRS Scores - From Post EP2 to 8 Hours Post-dose|Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 2= first time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP2 is approximately a time point 4-5 hours post-dose. Maximum pain score in period from post EP2 to 8 hours post-dose is reported.|From post EP2 to 8 hours post-dose|"Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure."|||Units on a scale||Standard Deviation|Mean
2638948|NCT01769274|Secondary|Average PI-NRS Scores - From Post Evoked Pain Time Point 4 (EP4) to 28 Hours Post-dose|Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 4= third time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP4 is approximately a time point 24-25 hours post-dose. The average pain score was calculated as the mean of the pain scores recorded from EP4 to 28 hours post-dose.|Post EP4, every 5 minutes for the first hour, then every 15 minutes up to 28 hours post-dose|"Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure."|||Units on a scale||Standard Deviation|Mean
2638949|NCT01769274|Secondary|Average PI-NRS Scores - From Post Evoked Pain Time Point 3 (EP3) to 10 Hours Post-dose|Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 3= second time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP3 is approximately a time point 8-9 hours post-dose. The average pain score was calculated as the mean of the pain scores recorded from EP3 to 10 hours post-dose.|Post EP3, every 5 minutes for the first hour, then every 15 minutes up to 10 hours post-dose|"Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure."|||Units on a scale||Standard Deviation|Mean
2638950|NCT01769274|Secondary|Average PI-NRS Score - From Post Evoked Pain Time Point 2 (EP2) to 8 Hours Post-dose|Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10. Where 0= no pain and 10= worst possible pain; higher scores signify more pain. Evoked pain time point 2= first time point post-dose when pain was evoked using the participant specific heat pain stimulus. EP2 is approximately a time point 4-5 hours post-dose. The average pain score was calculated as the mean of the pain scores recorded from EP2 to 8 hours post-dose.|Post EP2, every 5 minutes for the first hour, then every 15 minutes up to 8 hours post-dose|"Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication. Overall Number of Participants Analyzed = participants evaluable for this outcome measure."|||Units on a scale||Standard Deviation|Mean
2638951|NCT01769274|Primary|Average Pain Intensity Numerical Rating Scale (PI-NRS) Score - From 0 to 4 Hours Post-dose|Participants rated severity of their pain at 11 point PI-NRS, by choosing a number between 0 and 10, where 0= no pain and 10= worst possible pain; higher scores signify more pain. The average pain score was calculated as the mean of the pain scores recorded every 15 minutes from 0 to 4 hours post-dose.|Every 15 minutes from 0 to 4 hours post-dose|Full analysis set included all participants who successfully completed Part A, were randomized in Part B, and who received at least 1 dose of randomized study medication.|||Units on a scale||Standard Deviation|Mean
2638952|NCT01769248|Secondary|Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%)|As above. Crossover to FNA or FNB occurs after 3 passes without adequate material|1 yr|Participants receiving alternative tissue acquisition method when initial three passes with either EUS-FNA or EUS-FNB failed to provide an adequate specimen.|||percentage of participants|||Number
2638953|NCT01769248|Secondary|Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB|The investigators' secondary outcome will assess the ability to obtain an adequate specimen for in room cytologic evaluation as determined by our cytopathologist. This will be defined as a sample that is representative (not necessarily diagnostic) of the lesion in question. This will be expressed as a percentage and compared between FNA and FNB|1 year|Patients with pancreatic and non-pancreatic lesions receiving EUS-FNA and EUS-FNB.|||percentage of participants|||Number
2638954|NCT01769248|Primary|Diagnostic Yield of EUS-FNB and EUS-FNA|The investigators' primary outcome measure will assess the diagnostic yield (percentage of patients with a diagnosis) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled. This will be expressed as a percentage.|1 year||||percentage of patients|||Number
2638955|NCT01769222|Secondary|Duration of Response (Phase 2 Only)|Data will be summarized using Kaplan-Meier estimates for time to event data.|Up to 5 years|||||||
2638956|NCT01769222|Secondary|Overall Survival (Phase 2 Only)|Data will be summarized using Kaplan-Meier estimates for time to event data.|Up to 5 years|||||||
2638957|NCT01769222|Secondary|Response Rate (Phase 2 Only)|Response rates calculated based on the Response Evaluation Criteria in Solid Tumors (RECIST)/RECIST Immunotherapy and Cheson criteria (Phase 2 only). Response rate data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.|8 weeks||2017-01-31|01/2017||||
2638958|NCT01769222|Secondary|Immune Response (Phase 2 Only)|Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.|8 weeks|||||||
2638959|NCT01769222|Secondary|Immune Response (Phase 2 Only)|Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.|4 weeks|||||||
2638960|NCT01769222|Primary|Dose-limiting Toxicity|Safety as the percentage of patients experiencing dose-limiting toxicities (DLTs) or serious adverse events (SAEs) using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)|4 weeks||||percentage of participants|||Number
2638961|NCT01769209|Secondary|Induction of Reactive Oxygen Species (ROS)|Circulating acute lymphoblastic leukemia (ALL) blast cells were to be evaluated for the presence of reactive oxygen species (ROS).|2 years|Assay development was unsuccessful, and the assessment and analysis were not conducted for any samples.||||||
2638962|NCT01769209|Secondary|Related Adverse Events (Grade 3, 4, 5)|Toxicity was assessed as related grade 3, 4, or 5 adverse events (AEs) per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. The outcome is reported as the total numbers of events (without dispersion) by CTCAE Body System, and whether the event was a hematologic toxicity or non-hematologic toxicity.|45 days|"Events specifically defined per protocol as Hematologic Toxicity orNon-hematologic Toxicity are included under the specific Body System and as a Hematologic or Non-hematologic Toxicity."|||Treatment-related adverse events|||Number
2652091|NCT01656252|Secondary|Phase II- Bleeding Event Occurrence|To determine the impact of eltrombopag on occurrence of bleeding events.|62 months|||||||
2638964|NCT01769209|Secondary|Failure-free Survival (FFS)|"Failure-free survival (FFS) was assessed as survival without progression or the addition of another systemic therapy, at or within 2 years. The outcome is reported as the number (without dispersion) of the participants alive without progression. Progression is defined below.~Progression = More than 25% increase in circulating and/or bone marrow blasts, or the development of extramedullary disease."|1 year||||Participants|||Count of Participants
2638965|NCT01769209|Secondary|Progression-free Survival (PFS)|"Progression-free survival (PFS) was assessed as survival without progression at 2 years. The outcome is reported as the number (without dispersion) of the participants alive without progression.~Progression = More than 25% increase in circulating and/or bone marrow blasts, or the development of extramedullary disease."|2 years||||Participants|||Count of Participants
2638966|NCT01769209|Secondary|Complete Response Without Platelet Recovery (CRp)|"Complete response without platelet recovery (CR) was determined as the number of participants who achieved CRp by Day 29 after induction treatment. The outcome is reported as the total number without dispersion. The outcome reflects only those subjects that meet all complete response (CR) criteria except platelet count; participants that meet all criteria including platelet count are not included in this outcome. CR and CRp are defined below.~CR =.No circulating blasts or extramedullary disease; trilineage hematopoiesis; absolute neutrophil count (ANC) > 1,000/microliter; platelets > 100,000/microliter; < 5% blasts in bone marrow.~CRp = Meets all criteria for CR except platelet count."|Day 29||||Participants|||Count of Participants
2638967|NCT01769209|Secondary|Complete Response (CR)|"Complete response (CR) was determined the number of participants who achieved CR by Day 29 after induction treatment. The outcome is reported as the total number without dispersion. CR is defined as:~CR = No circulating blasts or extramedullary disease; trilineage hematopoiesis; absolute neutrophil count (ANC) > 1,000/microliter; platelets > 100,000/microliter; < 5% blasts in bone marrow.~Not CR = All statuses and conditions if less than or not as defined."|Day 29||||Participants|||Count of Participants
2638968|NCT01769209|Primary|Response Rate (RR)|"Response Rate (RR) was determined as the sum of complete response (CR) and partial response (PR). Due to overlap, complete response rate without platelet recovery (CRp) is not included in Response Rate (RR). The outcome is reported as the total number without dispersion.~CR = No circulating blasts or extramedullary disease; trilineage hematopoiesis; absolute neutrophil count (ANC) > 1,000/microliter; platelets > 100,000/microliter; < 5% blasts in bone marrow.~CRp = Meets all criteria for CR except platelet count.~PR = Meets all criteria for CR except bone marrow contains 5 to 25% leukemia cells."|Day 29||||Participants|||Count of Participants
2638969|NCT01769196|Secondary|Absolute Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Score|"The SGRQ is a disease-specific questionnaire designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Patients respond to questions about symptoms (frequency & severity) and impact components (social functioning and psychological disturbances resulting from airways disease). Scores range from 0 to 100, with higher scores indicating more limitations.~The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase."|Week 58, 106, and 130|Participants in the ITT Analysis Set with available data were analyzed. Any participant with available outcome data on baseline or post-baseline was included in the MMRM model, thus all 272 participants in each of the two treatment groups were included in this analysis.|||units on a scale||Standard Error|Least Squares Mean
2638970|NCT01769196|Secondary|Absolute Change From Baseline in 6 Minute Walk Distance (6MWD)|"Adjusted means were from MMRM model with baseline 6MWD, FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130.~The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase."|Weeks 58, 106, and 130|Participants in the ITT Analysis Set with available data were analyzed. Any participant with available outcome data on baseline or post-baseline was included in the MMRM model, thus all 272 participants in each of the two treatment groups were included in this analysis.|||Meters||Standard Error|Least Squares Mean
2638971|NCT01769196|Secondary|Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death||Up to 148 weeks|Participants in the ITT Analysis Set with adjudicated deaths were analyzed.|||Participants|||Count of Participants
2638972|NCT01769196|Secondary|Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations||Up to 148 weeks|Participants in ITT Analysis Set with total hospitalizations were analyzed.|||Participants|||Count of Participants
2638973|NCT01769196|Secondary|Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations||Up to 148 weeks|Participants in the ITT Analysis Set with adjudicated respiratory hospitalizations were analyzed.|||Participants|||Count of Participants
2638974|NCT01769196|Secondary|Relative Change From Baseline in FVC % Predicted|"FVC was defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted was defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition.~Adjusted means were from mixed model repeated measures (MMRM) model with baseline FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130~The relative change was calculated as 100% * ( value at later time point minus value at baseline ) / value at baseline, with lower values indicating a decrease and higher values indicating an increase."|Weeks 54, 106, and 130|Participants in the ITT Analysis Set with available data were analyzed. Any participant with available outcome data on baseline or post-baseline was included in the MMRM model, thus all 272 participants in each of the two treatment groups were included in this analysis.|||Percent change in FVC % predicted||Standard Error|Least Squares Mean
2638975|NCT01769196|Secondary|Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile||Up to 151 weeks|Participants in the ITT Analysis Set with sLOXL2 ≥ 75th percentile in peripheral blood were analyzed.|||months||95% Confidence Interval|Median
2638976|NCT01769196|Secondary|Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile||Up to 151 weeks|Participants in the ITT Analysis Set with sLOXL2 ≥ 50th percentile in peripheral blood were analyzed.|||months||95% Confidence Interval|Median
2639611|NCT01763866|Secondary|Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2638980|NCT01769196|Primary|Progression Free Survival|Progression free survival (PFS) was defined as the categorical decrease in forced vital capacity (FVC) % predicted (≥ 10% relative decrease in FVC and ≥ 5% absolute decrease in FVC from baseline) with confirmation at a consecutive visit at least 2 weeks later using the same criteria.|Up to 148 weeks|ITT Analysis Set|||months||95% Confidence Interval|Median
2638981|NCT01769105|Secondary|Change in Expressible Meibomian Glands|expressible Meibomian glands are measured with the Meibomian gland evaluator; A higher number of expressible Meibomian glands indicate a lower likelihood Meibomian Gland dysfunction.|after 3 month compared to baseline value||||number of expressible glands||Standard Deviation|Mean
2638982|NCT01769105|Secondary|Change in Lipid Layer Thickness|"lipid layer thickness (LLT) is measured with the Lipiview-interferometer;~High values of LLT indicate a better lubrication of the ocular surface, so an increase in LLT can be regarded in an improvement of ocular surface.~LLT is measured in Interferometric color units (ICUs) whereas 1 ICU reflects about 1 nm lipid layer thickness."|after 3 month compared to baseline value||||nm||Standard Deviation|Mean
2638983|NCT01769105|Secondary|Change in Tear Film Osmolarity|"osmolarity is measured with the tear-lab;~The osmolarity is measured in mOsm/l. A higher osmolarity can be regarded as an objective sign of dry eye disease.~A lower osmolarity after therapy can be regarded as an improvement of ocular surface disease."|after 3 month compared to baseline value||||mOsm/L||Standard Deviation|Mean
2638984|NCT01769105|Secondary|Change of Break-up-time|"break-up-time is measured non-invasive with the Oculus Keratograph 5 M;~The break-up-time is measured in seconds. A low break-up-time suggests a lower lipid layer thickness. A higher break-up-time can be regarded as an improvement of ocular surface lubrication."|after 3 month compared to baseline value||||seconds||Standard Deviation|Mean
2638985|NCT01769105|Primary|Change of Dry Eye Symptoms|"The symptoms of dry eyes are measured in our study with the OSDI and the SPEED questionaire. Primary outcome measure (OSDI)~Patients completed two symptom questionnaires: OSDI (Ocular Surface Disease Index) and SPEED (Standard Patient Evaluation of Eye dryness).~OSDI scores range from 0 (no symptoms) to 100 (severe symptoms). SPEED scores range from 0 (no symptoms) to 28 (severe symptoms). So a reduction of the OSDI or SPEED score indicates an improvement of subjective dry eye symptoms."|after 3 month compared to baseline value||||units on a scale||Standard Deviation|Mean
2638986|NCT01768858|Secondary|Change in Psoriasis Area and Severity Index (PASI) Score Over Time|The Psoriasis Area and Severity Index (PASI) is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline, Month 3, Month 6, Month 9, Month 12|Participants with psoriasis with available data|||units on a scale||Standard Deviation|Mean
2638987|NCT01768858|Secondary|Changes in Erythrocyte Sedimentation Rate (ESR) Over Time|Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body, and is based on the sedimentation and aggregation of erythrocytes (red blood cells). A higher ESR is indicative of increased inflammation. The normal range in healthy individuals is 0 - 10 mm/h for men and 0-15 mm/h for women.|Baseline, Month 3, Month 6, Month 9, Month 12|Participants with available data|||mm/hr||Standard Deviation|Mean
2638988|NCT01768858|Secondary|Change in C-reactive Protein (CRP) Concentration Over Time|C-reactive protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy individuals is usually lower than 1 mg/dL, slightly increasing with age, and increased in a variety of disorders such as rheumatic diseases.|Baseline, Month 3, Month 6, Month 9, Month 12|Participants with available data|||mg/dL||Standard Deviation|Mean
2638989|NCT01768858|Secondary|Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Over Time|The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity.|Baseline, Month 3, Month 6, Month 9, Month 12|Participants with ankylosing spondylitis with available data|||units on a scale||Standard Deviation|Mean
2638990|NCT01768858|Secondary|Change in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores Over Time|The RADAI is a questionnaire for participants used for measuring disease activity. The index consists of 6 questions. The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness, and (6) tender joints rated on a joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The first 4 items are rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity. The scores on the last 2 items range from 0 to 6 and 0 to 48, respectively, but are transformed on the same scale of 0 to 10. The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.|Baseline, Month 3, Month 6, Month 9, Month 12|Participants with rheumatoid arthritis with available data|||units on a scale||Standard Deviation|Mean
2638991|NCT01768858|Secondary|Change in the Treatment Satisfaction Questionnaire for Medication (TSQM) Scores From Month 3 to Month 12|The 11-item Treatment Satisfaction Questionnaire for Medication (TSQM) Version II is an instrument to assess participants' satisfaction with medication, providing scores on four scales (side effects, effectiveness, convenience, and global satisfaction). The 11 questions can be answered either with yes/no or by means of a five or seven stage scale (ranging from very unsatisfied to satisfied). TSQM Scale scores range from 0 to 100 and higher scores represent higher satisfaction.|At Month 3 and Month 12|Participants with available data|||units on a scale||Standard Deviation|Mean
2639062|NCT01768013|Primary|Pharmacokinetic: AUClast of Calcipotriol|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined|Day 1||||h*pg/mL||Standard Deviation|Mean
2638992|NCT01768858|Secondary|Change in Morisky Medication Adherence Scale (MMAS) Scores From Month 3 to Month 12|The MMAS is a 4-item self-reported measure of medication-taking behavior. It measures intentional and non-intentional non-adherence (based on forgetting, carelessness, stopping medication when feeling better, or stopping medication when feeling worse). The MMAS consists of 4 questions which can be answered with yes (0) and no (1). The MMAS score is the sum of all four questions and ranges from 0 (non-adherent) to 4 (adherent).|At Month 3 and Month 12|Participants with available data|||units on a scale||Standard Deviation|Mean
2638993|NCT01768858|Primary|Correlation Between Beliefs About Medicines Questionnaire (BMQ) Specific Score and Adherence to Treatment as Measured by the Morisky Medication Adherence Scale (MMAS) at 12 Months|The BMQ-Specific Scale comprises two 5-item factors assessing beliefs about the necessity of prescribed medication (Specific-Necessity) and concerns about prescribed medication based on beliefs about the danger of dependence, long-term toxicity, and the disruptive effects of medication (Specific-Concerns). Individual items are scored on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 (lowest score) to 50 (highest score). Higher scores indicate stronger beliefs. The MMAS is a 4-item self-reported measure of medication-taking behavior. It measures intentional and non-intentional non-adherence (based on forgetting, carelessness, stopping medication when feeling better, or stopping medication when feeling worse). The MMAS consists of 4 questions which can be answered with yes (0) and no (1). The MMAS score is the sum of all four questions and ranges from 0 (non-adherent) to 4 (adherent).|Baseline and 12 months|Participants with available data|||Spearman correlation coefficient|||Number
2638994|NCT01768858|Primary|Change From Baseline in the Beliefs About Medicines Questionnaire (BMQ) Specific Score at 12 Months|The BMQ-Specific Scale comprises two 5-item factors assessing beliefs about the necessity of prescribed medication (Specific-Necessity) and concerns about prescribed medication based on beliefs about the danger of dependence, long-term toxicity, and the disruptive effects of medication (Specific-Concerns). Individual items are scored on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 (lowest score) to 50 (highest score). Higher scores indicate stronger beliefs.|Baseline and 12 months|Participants with available data|||units on a scale||Standard Deviation|Mean
2638995|NCT01768832|Secondary|Walking Velocity at 3 Months and 6 Months|Walking velocity during forward and backward walking as determined by a computerized mat.|3 and 6 months|Analysis included only those participants who completed the 6 month visit.|||cm/sec||Inter-Quartile Range|Median
2638996|NCT01768832|Secondary|PDQ-39 Scores at 3 Months and 6 Months|The Parkinson Disease Quality of Life Questionnaire is a 39-item tool rating quality of life with higher scores indicating better quality of life. Scores range from 0 to 195.|3 and 6 months||||score on a scale||Standard Deviation|Mean
2638997|NCT01768832|Secondary|Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at 3 Months and 6 Months|The Movement Disorder Society Unified Parkinson Disease Rating Scale - Subscale III is a standardized rating of motor symptom severity in Parkinson disease. Scores range from 0 to 132 with higher scores being worse, i.e. higher scores indicate more severe disease.|3 and 6 months|Analysis included only participants who completed the study visit at the six month time point.|||score on a scale||Inter-Quartile Range|Median
2638998|NCT01768832|Secondary|Mini Balance Evaluation Systems Test (Mini-BESTest) at 3 and 6 Months|The Mini Balance Evaluation Systems Test (Mini-BESTest) is a clinical assessment of balance ability. Score range from 0 to 28 with higher scores indicating better balance.|3 and 6 months||||score on a scale||Inter-Quartile Range|Median
2638999|NCT01768832|Secondary|Movement Disorder Society Unified Parkinson Disease Rating Scale Subscale III at Baseline to 3 Months|The Movement Disorder Society Unified Parkinson Disease Rating Scale - Subscale III is a standardized rating of motor symptom severity in Parkinson disease. Scores range from 0 to 132 with higher scores being worse, i.e. higher scores indicate more severe disease.|0 and 3 months||||score on a scale||Inter-Quartile Range|Median
2639000|NCT01768832|Secondary|PDQ-39 Scores at Baseline and 3 Months|The Parkinson Disease Quality of Life Questionnaire is a 39-item tool rating quality of life with higher scores indicating better quality of life. Scores range from 0 to 195.|0 and 3 months||||score on a scale||Standard Deviation|Mean
2639001|NCT01768832|Secondary|Mini Balance Evaluation Systems Test (Mini-BESTest) at Baseline and 3 Months|The Mini Balance Evaluation Systems Test (Mini-BESTest) is a clinical assessment of balance ability. Score range from 0 to 28 with higher scores indicating better balance.|0 and 3 months||||score on a scale||Inter-Quartile Range|Median
2639002|NCT01768832|Secondary|Blood Oxygen Level Dependent Signal at Baseline to 3 Months|Measure of the ratio of oxygenated to deoxygenated blood in areas of the brain at a specific time. Used as an indirect assessment of brain activity and connections. Higher values indicate more brain activity in the brain areas of interest.|0 and 3 months|Due to issues with data quality related to head movement while in the MRI scanner, we had a limited numbers of participants in each group with usable MRI data.|||ratio||Standard Deviation|Mean
2639003|NCT01768832|Primary|Walking Velocity at Baseline and 3 Months|Walking velocity during forward and backward walking as determined by a computerized mat.|0 and 3 months||||cm/sec||Standard Deviation|Mean
2639004|NCT01768676|Secondary|Percentage of Subjects With Greater Than or Equal to 50% Reduction in Normal Sperm Morphology From Baseline to Week 26||baseline to week 26|completers population|||percentage of participants|||Number
2639005|NCT01768676|Secondary|Percentage of Subjects With Greater Than or Equal to 50% Reduction in Semen Volume From Baseline to Week 26||baseline to week 26|completers population|||percentage of participants|||Number
2639006|NCT01768676|Secondary|Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Motility From Baseline to Week 26|Sperm motility was based upon the WHO grading scale: grade A, B, or C.|baseline to week 26|completers population|||percentage of participants|||Number
2639007|NCT01768676|Secondary|Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Count From Baseline to Week 26||baseline to week 26|completers population|||percentage of participants|||Number
2639008|NCT01768676|Primary|Percentage of Subjects With a Greater Than or Equal to 50% Decrease in Sperm Concentration From Baseline to Week 26|Subjects provided 2 semen samples at each visit 2 to 12 days apart. The average value is used as the visit result.|Baseline to Week 26|Completer population is defined as those who completed the study through week 26 and had semen analysis at both baseline and week 26. This may differ from the definition of completers for the study flow.|||percentage of participants|||Number
2639009|NCT01768637|Secondary|Whole Blood Platelet Aggregation to 20 µg/mL Adenosine Diphosphate|Citrated whole blood was used to measure platelet aggregation induced by agonist (adenosine diphosphate at 20mM concentration) using impedance whole blood platelet aggregometry via a Chrono-log aggregometer. Values at baseline (visit 1) and on aspirin (visit 2) was compared between groups with post treatment values (visit 3) after 2 weeks of aspirin and clopidogrel treatment|4 weeks||||ohms||Inter-Quartile Range|Mean
2639010|NCT01768637|Secondary|Whole Blood Platelet Aggregation to 2 µg/mL Collagen|Citrated whole blood was used to measure platelet aggregation induced by agonist (collagen at 2mM concentration) using impedance whole blood platelet aggregometry via a Chrono-log aggregometer. Values at baseline (visit 1) was compared between groups with post treatment values (visit 2) after 2 weeks of aspirin treatment|2 weeks||||ohms||Inter-Quartile Range|Median
2639011|NCT01768637|Primary|Whole Blood Platelet Aggregation to 0.5 Millimoles Arachidonic Acid|Citrated whole blood was used to measure platelet aggregation induced by agonist (arachidonic acid at 5 mM concentration) using impedance whole blood platelet aggregometry via a Chrono-log aggregometer. Values at baseline (visit 1) was compared between groups with post treatment values (visit 2) after 2 weeks of aspirin treatment|2 weeks||||ohms||Inter-Quartile Range|Median
2639012|NCT01768572|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. All adverse events that occurred from the first dose of the study drug administration up to 60 days after the end of treatment visit were considered as TEAEs. Serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. A summary of SAEs, all other non-serious AEs, regardless of causality, are reported in AE section.|Up to 211 days|The safety population consisted of all randomized participants who received at least 1 dose or a partial dose of study drug analyzed according to the treatment actually received.|||participants|||Number
2639013|NCT01768559|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7%, Had no Weight Gain at Week 26, and Did Not Experience Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26-Week Treatment Period|The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug. Participants without post-baseline on-treatment values (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response, or if they experienced at least one documented symptomatic hypoglycemia during the on-treatment period. Otherwise, they were counted as missing data.|Week 26|mITT population.Participants without post-baseline on-treatment values(HbA1c;body weight),no more than 30 days apart counted as non-responders if at least one of components(HbA1c;body weight) was available,showed non-response or experienced at least one symptomatic hypoglycemia during on-treatment period.Otherwise,they were counted as missing data.|||percentage of participants|||Number
2639014|NCT01768559|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% and Had no Weight Gain at Week 26|The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for body weight assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug.|Week 26|mITT population. Participants without post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed non-response. Otherwise, they were counted as missing data.|||percentage of participants|||Number
2639015|NCT01768559|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% at Week 26 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26 Week Treatment Period|The on-treatment period for HbA1c assessment was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. The on-treatment period for symptomatic hypoglycemia assessment was defined as the time from the first dose of study drug up to 1 day after the last dose of study drug.|Week 26|mITT population. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.|||percentage of participants|||Number
2639016|NCT01768559|Secondary|Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <60 mg/dL (3.3 mmol/L). Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the participant required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.|First dose of study drug up to 3 days after the last dose administration (maximum of 185 days)|"All randomized participants who were exposed to at least one dose of study drug, regardless of the amount of treatment administered.~The 4 participants in the TID group who received Insulin Glulisine QD were analyzed according to the QD dose.The 1 participant in the QD group who received Insulin Glulisine TID was analyzed according to the TID dose"|||percentage of participants|||Number
2639017|NCT01768559|Secondary|Total Insulin Dose at Week 26|"The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.~The outcome is reporting results of total insulin (amounts of Insulin Glargine plus Insulin Glulisine ) only for the arms in which Insulin Glulisine was administered and is not applicable for the lixisenatide arm in which only Insulin Glargine is administered. Change in dose of the insulin used by patients in the Lixisenatide arm (i.e. Insulin Glargine) is reported in the secondary Outcome Measure 9."|Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline total insulin dose assessment during on-treatment period.|||U||Standard Deviation|Mean
2639018|NCT01768559|Secondary|Insulin Glulisine Dose at Week 26|The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug. Missing data was imputed using LOCF.|Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline insulin glulisine dose assessment during on-treatment period.|||U||Standard Deviation|Mean
2639019|NCT01768559|Secondary|Change in Insulin Glargine Dose From Baseline to Week 26|Change in Insulin glargine dose was calculated by subtracting the baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline insulin glargine dose assessment during on-treatment period.|||U||Standard Error|Least Squares Mean
2639020|NCT01768559|Secondary|Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast)|Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test, before study drug administration. Change in glucose excursions was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with IMP injection before breakfast and baseline and at least one post-baseline glucose excursion assessment during on-treatment period.|||mmol/L||Standard Deviation|Mean
2639021|NCT01768559|Secondary|Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast)|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with IMP injection before breakfast and baseline and at least one post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Deviation|Mean
2639022|NCT01768559|Secondary|Change in FPG From Baseline to Week 26|Change in FPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2639023|NCT01768559|Secondary|Change in Average 7-point SMPG Profiles From Baseline to Week 26|Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime three times in a week before baseline, before visit Week 12 and before visit week 26 and the average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug.|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2639024|NCT01768559|Secondary|Percentage of Participants With no Weight Gain at Week 26|The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 3 days after the last dose of study drug.|Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.|||percentage of participants|||Number
2639025|NCT01768559|Secondary|Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26|The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Missing data was imputed using LOCF.|Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2639026|NCT01768559|Primary|Change in Body Weight From Baseline to Week 26|"Primary outcome was the comparison between Lixisenatide versus Insulin Glulisine TID.~Change in body weight was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug."|Baseline, Week 26|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.|||kg||Standard Error|Least Squares Mean
2639027|NCT01768559|Primary|Change in HbA1c From Baseline to Week 26|Change in HbA1C was calculated by subtracting baseline value from Week 26 value. Missing data was imputed using last on-treatment observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.|Baseline, Week 26|modified intent-to-treat (mITT) population: all randomized participants who received at least one dose of study drug; and had both baseline and at least one post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2639028|NCT01768520|Secondary|the Change of Numeric Rating Scale|"Numeric Rating Scale is 10 point scale(0~10 score). 0 score: no pain, 10 score: worst possible pain~If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed."|baseline and 12 weeks||||score on a scale||Standard Deviation|Mean
2639029|NCT01768520|Primary|the Change of Total Sum of K-WOMAC(Korean The Western Ontario and McMaster Universities Arthritis Index)|"Range of total K-WOMAC score: 0-96 K-WOMAC consists of evaluations of pain, stiffness, physical function. The total K-WOMAC score is the sum of all subscale scores. Higher scores mean a worse outcome.~Range of Subscale K-WOMAC score: pain(0-20), stiffness(0-8), physical function(0~68) Higher scores mean a worse outcome.~If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed."|baseline and 12 weeks||||score on a scale||Standard Deviation|Mean
2639030|NCT01768325|Secondary|Number of Needle Passes||36 months||||Needle passes||Standard Deviation|Mean
2639033|NCT01768286|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as on-treatment virologic failure or virologic relapse.~On-Treatment Virologic Failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)~Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit."|Baseline to posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2639034|NCT01768286|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2639035|NCT01768286|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
2639036|NCT01768286|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
2639037|NCT01768286|Secondary|Change From Baseline in HCV RNA at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2639038|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 24||Week 24|Participants in the Full Analysis Set with available data were analyzed. Participants in the LDV/SOF 12 Weeks and LDV/SOF+RBV 12 Weeks groups did not continue treatment past Week 12 and are not included in the analysis.|||percentage of participants|||Number
2639039|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 12||Week 12|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2639040|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2639041|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Full Analysis Set|||percentage of participants|||Number
2639042|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Full Analysis Set|||percentage of participants|||Number
2639043|NCT01768286|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 1||Week 1|Full Analysis Set|||percentage of participants|||Number
2639044|NCT01768286|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
2639045|NCT01768286|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug|The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.|Up to 24 weeks|Safety Analysis Set|||percentage of participants|||Number
2639046|NCT01768286|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants who were randomized and received at least one dose of study drug.|||percentage of participants|||Number
2639047|NCT01768117|Secondary|Number of Participants With 4-fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level||1 month after vaccination 3||||participants|||Number
2639048|NCT01768117|Secondary|Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ For All 4 Primary Test Strains Combined||1 month after vaccination 3||||participants|||Number
2639049|NCT01768117|Secondary|Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= LLOQ||1 month after vaccination (Vac) 1, 2, Immediately prior to vaccination 3||||participants|||Number
2639050|NCT01768117|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Vaccination 1 up to 1 month after Vaccination 3||||percentage of participants|||Number
2639051|NCT01768117|Primary|Number of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)||1 month after vaccination 3||||participants|||Number
2639052|NCT01768013|Secondary|Efficacy: Subjects With 'Clear' or 'Almost Clear' Disease by Investigator's Global Assessment at Day 28.|"Subjects with 'clear' or 'almost clear' disease by investigator's globala ssessment at day 28.~Investigator global assessment (IGA) is based on the investigator's assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear,Almost clear, Mild,Moderate, Severe, and Very severe). The assessment represents the average lesion severity on the trunk and limbs. IGA can range between 1 (best) and 6 (worst). The assessment is based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit."|Day 28||||participants|||Number
2639053|NCT01768013|Secondary|Efficacy: Percentage Change in m-PASI From Baseline to Day 28|"Psoriasis Area and Severity Index (PASI) is based on the investigator's assessment of the disease.~The extent and severity of redness, thickness and scaliness of psoriasis are recorded for three regions (arms, trunk and legs) and these are used to calculate PASI. The PASI can range between 0 (best) to 64.8 (worst). m-PASI indicate that the scale is modified."|Baseline to Day 28||||percentage of change||Standard Deviation|Mean
2639054|NCT01768013|Primary|Pharmacokinetic: AUClast of MC1080.|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined|Day 14||||h*pg/mL||Standard Deviation|Mean
2639055|NCT01768013|Primary|Pharmacokinetic: AUClast of MC1080.|To assess the The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined|Day 7||||h*pg/mL||Standard Deviation|Mean
2639056|NCT01768013|Primary|Pharmacokinetic: AUClast of MC1080|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined|Day 1||||h*pg/mL||Standard Deviation|Mean
2639057|NCT01768013|Primary|Pharmacokinetic: Cmax of MC1080|The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined|Day 14||||pg/mL||Standard Deviation|Mean
2639066|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone 17-propionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined|Day 14||||h*pg/mL||Standard Deviation|Mean
2639067|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone 17-propionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined|Day 7||||h*pg/mL||Standard Deviation|Mean
2639068|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone 17-propionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined|Day 1||||h*pg/mL||Standard Deviation|Mean
2639069|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone 17-propionate|The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined|Day 14||||pg/mL||Standard Deviation|Mean
2639070|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone 17-propionate|The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined|Day 7||||pg/mL||Standard Deviation|Mean
2639071|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone 17-propionate|The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined|Day 1||||pg/mL||Standard Deviation|Mean
2639072|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone Dipropionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined|Day 14||||h*pg/mL||Standard Deviation|Mean
2639073|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone Dipropionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined|Day 7||||h*pg/mL||Standard Deviation|Mean
2639074|NCT01768013|Primary|Pharmacokinetic: AUClast of Betamethasone Dipropionate|The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined|Day 1||||h*pg/mL||Standard Deviation|Mean
2639075|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone Dipropionate|The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined|Day 14||||pg/mL||Standard Deviation|Mean
2639076|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone Dipropionate|The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined|Day 7||||pg/mL||Standard Deviation|Mean
2639077|NCT01768013|Primary|Pharmacokinetic: Cmax of Betamethasone Dipropionate|The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined.|Day 1||||pg/mL||Standard Deviation|Mean
2639078|NCT01768000|Secondary|Involvement Evaluation Questionnaire (IES)|The 31-item Involvement Evaluation Questionnaire (IEQ; Van Wijngaarden et al., 2000) measures caregiver burden. It has been validated for caregivers of individuals with schizophrenia, covers a broad domain of caregiving consequences and refers to burden experienced within the past 4 weeks. Mean scores are calculated for the total scale and sub-scales. Total scores can range from 29 to 145 with sub-scale domains ranging - tension, 9-45; supervision, 6-30; worrying, 6-30; and urging, 8-40. Lower total and subscale scores indicate less burden and higher scores greater level of caregiver burden.|4 months following baseline assessment||||units on a scale||Standard Deviation|Mean
2639079|NCT01768000|Secondary|Satisfaction With Life Scale|8 out of 18 items from the Satisfaction With Life Scale (Test et al., 2005) will measure the perceived quality of life of the individual with schizophrenia by tapping into global satisfaction in domains relevant to CAT (e.g., How satisfied are you with yourself on the whole? - 5 point scale, not at all - great deal). This scale is well-validated with a schizophrenia population and is being shortened as not all items are relevant to CAT nor expected to be sensitive to change in a 4 month period, and there is a need to abbreviate the battery to reduce the risk of fatigue in a lengthy phone interview. These 8 items comprise four domains of social relationships, employment/work, social and present life and living situation. A low score indicates less satisfaction in these domains and a higher score indicating greater satisfaction. Total scores can range from 8-40 and subscale scores range from 1-5.|4 months following baseline assessment||||units on a scale||Standard Deviation|Mean
2639080|NCT01768000|Secondary|Brief Adherence Rating Scale (BARS)|The Brief Adherence Rating Scale (BARS; Byerly et al., 2008) is a 4-item, valid, reliable, sensitive, measure with which to obtain specific estimates of antipsychotic medication adherence of outpatients with schizophrenia. A total percentage score on a scale ranging from 0 to 100, with 0 indicating less adherence and 100 total adherence.|4 months following baseline assessment||||units on a scale||Standard Deviation|Mean
2639081|NCT01768000|Primary|Multnomah Community Ability Scale (MCAS)|The Multnomah Community Ability Scale (MCAS; Barker et al., 1994) is a 17-item scale assessing functionality in four domains - health, adaptation, social skills and behaviour. Ratings are made on the basis of an interview with the patient and their family member. The MCAS generates a total score ranging from 17 to 85. Items on the MCAS are scored on a five-point scale. The four total domain scores ranges are - health, 5-25; adaptation, 3-15; social skills, 5-25; behaviour, 4-20. Lower ratings indicate less ability. Higher ratings usually mean an assessment of greater ability.|4 months following baseline assessment||||units on a scale||Standard Deviation|Mean
2639082|NCT01767987|Secondary|Successful PCI|For the purposes of this study, a successful PCI is considered one where no additional coronary interventions were required within 24 hours after the initial PCI.|At discharge or within 1 days, whichever comes first|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.|||participants|||Number
2639083|NCT01767987|Secondary|Death, MI, Revascularization, CHF||1-4 weeks post PCI||||participants|||Number
2639084|NCT01767987|Secondary|Death, Myocardial Infarction (Biomarker Greater Than 2x Normal), CHF, Cardiac Arrest||At discharge or within 1 days, whichever comes first|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.|||participants|||Number
2639251|NCT01766102|Primary|Comparison of Operative Time Savings|To compare the overall operative time savings using intra-operative digital mammography compared with standard specimen mammography.|At the time of the procedure (approximately 1 week after randomization)||||Minutes||Full Range|Median
2639085|NCT01767987|Secondary|Left Ventricular End Diastolic Pressure (LVEDP)||During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom this protocol required data point was collected.|||mmHG|||Number
2639086|NCT01767987|Secondary|Incidence of Non-sustained Ventricular Tachycardia or Atrial Fibrillation Post PCI||Following completion of PCI through hospital discharge|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.|||participants|||Number
2639087|NCT01767987|Secondary|Incidence of Atrial Fibrillation, Ventricular Tachycardia, or Ventricular Fibrillation in Coronary Cath Lab|Abnormal heart activity|During the PCI (Percutaneous Coronary Intervention) procedure - starting at timepoint of guidewire insertion into the access artery until removal of guidewire|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom these protocol required data points were collected.|||participants|||Number
2639088|NCT01767987|Secondary|TIMI Flow Rate (Grade)|"This TIMI classification was developed by the TIMI (Thrombolysis In Myocardial Infarction) study group to semiquantitatively assess coronary artery perfusion beyond point of occlusion on coronary angiography.* TIMI Grade [Description] TIMI 0 - no perfusion [no antegrade flow beyond the point of occlusion] TIMI 1 - penetration without perfusion [faint antegrade coronary flow beyond the occlusion with incomplete filling of the distal coronary bed] TIMI 2 - partial perfusion [delayed or sluggish antegrade flow with complete filling of the distal territory] TIMI 3 - complete perfusion [normal flow with complete filling of the distal territory]~*(see http://radclass.mudr.org/content/timi-grade-flow-grading-coronary-blood-flow-during-coronary-angiography) TIMI 0 is the least favorable grade. TIMI 3 is the most favorable grade."|TIMI Flow Rate (Grade) is assessed immediately after an interventional reperfusion attempt during a PCI (Percutaneous Coronary Intervention) procedure.|The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject for whom this protocol required data point was collected.|||units on a scale|||Number
2639089|NCT01767987|Primary|CK-MB|CK-MB labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first|8-10 hrs post PCI|For the single subject completing the PCI intervention, CK-MB was not done because the CK level was below the threshold running the CK-MB test.||||||
2639090|NCT01767987|Primary|Troponin|Troponin labs will be drawn 8-10 hrs after PCI or at discharge whichever comes first|8-10 hrs post PCI|Of the 4 Ranolazine Group subjects, 1 was withdrawn for pre-procedure study drug non-compliance; 3 had no PCI intervention. Of the 2 Placebo Group subject, 1 had no PCI intervention. The only subject undergoing PCI intervention was from the Placebo Group and was thus the only subject undergoing this protocol required test.|||NG/ML|||Number
2639091|NCT01767935|Secondary|Number of Participants Who Survived|Count of participants that survived.|Up to 24 weeks post-cryosurgery||||Participants|||Count of Participants
2639092|NCT01767935|Secondary|Pain After Cryosurgery, as Measured by the BPI|Questions #4 (least pain), #5 (average pain), and #6 (right now) from the BPI (reported on 0-10 scale) will be used as the secondary outcome measures. Higher scores denotes worse outcome|Up to 24 weeks||||score on a scale|||Number
2639093|NCT01767935|Secondary|Adverse Events, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0||Up to 24 weeks||||events|||Number
2639094|NCT01767935|Secondary|Pain Medication Level, Assessed by Changes in Narcotic Medication Usage|Pain medication assessments will be used to quantify any change in narcotic medication usage using the 24-hour morphine equivalent dose.|Baseline to 24 weeks||||mg|||Number
2639095|NCT01767935|Primary|Pain Level at 24 Hours Before Cryosurgery, as Measured by the BPI|Numerical scores (0-10) from the BPI will be used to measure pain levels. Higher scores denotes worse outcome.|24 hours||||score on a scale|||Number
2639096|NCT01767701|Other Pre-specified|Effect of Raltegravir Therapy on Specific Inflammatory Marker of MS Activity.|Measured by Human C-Reactive Protein (HCRP) which is a measure of general inflammation. The higher the value the more inflammatory response is present. The HCRP was measured monthly for six months. The mean value for the baseline three months was compared with the mean value taken for the second (treatment) three months.|Baseline to 6 months|ITT|||ng/mL||Full Range|Mean
2639097|NCT01767701|Other Pre-specified|Mean Number of Adverse Events Per Patient|"This outcome will be assessed by blood and urine sampling; collection of patient reported symptoms and neurological and physical exams.~This measure is the total number of adverse events recorded for each type of event during the study period. The number of participants is 31 which is the number screened and enrolled in the study. Eleven participants did not meet the criterion for baseline i.e. having a gadolinium enhancing lesion on MRI at the baseline visit and therefore did not continue to the baseline observation period. The adverse events for the 11 participants who did not begin the study observation period were recorded during the screening period and added to the 20 participants who were studied during the 6 months of the study. Adverse events are recorded as total number during the study period. Each patient may have had more than one adverse event."|Screening to six months|ITT|||Adverse events||Full Range|Mean
2639098|NCT01767701|Secondary|Percent of Subjects With Scans Free From Enhancing Lesions in Raltegravir Treated Subjects vs. Baseline|This measure is the cumulative percentage of subjects who had scans free from Gd enhancing lesions during the first three months (baseline) compared with the second three months (treatment). These percentages are expressed as a total percentage for the baseline and for the treatment periods.|Baseline to 6 months|ITT|||percentage of subjects|||Number
2639099|NCT01767701|Secondary|Cumulative Number of Gd-T1 Enhancing Lesions|This measure is the number of gadolinium-enhancing T1 lesions as determined by MRI taken on the monthly basis during the six months of the study.|At Baseline and monthly for 6 months|ITT|||Gadolinium enhancing T1 lesions||Full Range|Mean
2639127|NCT01767506|Primary|The Proportion of Communities With C. Trachomatis Infection Prevalence of 1% or Below|The proportion of communities with C. trachomatis infection prevalence at 1% or below in children ages 1 to 9 years at the 24-month survey, comparing the intervention arm to the usual practice arm|24 months|The trial was conducted at the community level|||community|community||Count of Units
2639594|NCT01763905|Secondary|Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639100|NCT01767701|Secondary|Changes in Kurtzke Extended Disability Status Scale (EDSS) Score|"The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis. The scale has been developed by John F. Kurtzke. The EDSS quantifies disability in eight Functional Systems (FS) and allows neurologists to assign a Functional System Score (FSS) in each of these. 0 = Normal 1-1.5 = No disability, but some abnormal neurological signs 2-2.5 = Minimal disability 3-4.5 = Moderate disability, affecting daily activities, but you can still walk. A lower score indicates less disability.~5-8 = More severe disability, impairing your daily activities and requiring assistance with walking 8.5-9.5 = Very severe disability, restricting you to bed 10 = Death EDSS scores were measured monthly over 6 months and the mean of the measurements for the first three months (baseline) was recorded to use calculate the change from baseline compared with the mean of measurements taken monthly during the second three months (treatment)."|Baseline and monthly to month 6|All patients enrolled in clinical trial|||units on a scale||Standard Deviation|Mean
2639101|NCT01767701|Secondary|Change in Score on Multiple Sclerosis Functional Composite (MSFC). This a Composite Score Based on the Measurement of Time in Seconds for the Three Separate Measurements.|Explore preliminary clinical responses in relapsing-remitting multiple sclerosis subjects treated with Raltegravir, compared with baseline as measured by Patient Reported Outcomes (Questionnaires). The MSFC is a composite score consisting of the standardly derived composite score from 9-hole peg test (9HPT), timed walk and PASAT scores. 9HPT is measured as timed speed to complete the task; higher scores indicate less disability. The 25-foot walk is measured as timed speed; higher scores indicate less disability. The Paced Auditory Serial Addition Test (PASAT) The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. It is a timed speed test measured in seconds. In the PASAT a lower score indicates less disability.|Baseline and monthly until month 6.|ITT|||seconds||Standard Deviation|Mean
2639102|NCT01767701|Secondary|The Cumulative Number of New or Enlarging T2 Weighted Lesions on Brain MRI.|"Demonstrate a reduction in the cumulative number of new or enlarging T2 weighted lesions on brain MRI over the period of treatment with Raltegravir compared with baseline.~Within-patient changes in lesion count calculated after-before."|Baseline and monthly for 6 months|ITT|||T2-weighted lesions||Full Range|Mean
2639103|NCT01767701|Primary|The Number of New or Recurrent Gd-enhancing Lesions That Appear on Brain T1-weighted MRI|"Demonstrate in subjects with relapsing remitting multiple sclerosis a reduction in the number of new or recurrent Gd-enhancing lesions that appear on brain T1-weighted MRI over the period of treatment with raltegravir, compared to baseline.~Within patient change in number of lesions was calculated by subtracting the after treatment period (3 months) minus before treatment period (3 months)."|Baseline and at 6 months|ITT|||lesions||Full Range|Mean
2639104|NCT01767688|Secondary|Number of Participants Discontinued From Study Due to AEs|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient/subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 days post-dose|All participants that received omarigliptin 25 mg.|||Participants|||Number
2639105|NCT01767688|Secondary|Number of Participants Experiencing Adverse Events (AEs)|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation patient/subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 14 days post-dose|All participants that received omarigliptin 25 mg.|||Participants|||Number
2639106|NCT01767688|Secondary|Apparent Terminal Phase Half-life (t½)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.|||hr||Geometric Coefficient of Variation|Geometric Mean
2639107|NCT01767688|Secondary|Time to Maximum Observed Plasma Drug Concentration (Tmax)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.|||hr||Full Range|Median
2639108|NCT01767688|Secondary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.|||nM||95% Confidence Interval|Geometric Mean
2639109|NCT01767688|Secondary|Plasma Concentration at 168 Hours After Dosing (C168h)||168 hours post-dose|All participants that received omarigliptin 25 mg.|||nM||95% Confidence Interval|Geometric Mean
2639110|NCT01767688|Secondary|Area Under the Concentration Versus Time Curve From Hour 0 to 168 Hours After Dosing (AUC0-168h)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.|||µM*hr||95% Confidence Interval|Geometric Mean
2639111|NCT01767688|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Hour 0 to Infinity (AUC0-∞)||Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96, and 168 hours post-dose|All participants that received omarigliptin 25 mg.|||µM*hr||95% Confidence Interval|Geometric Mean
2639112|NCT01767636|Secondary|Number of Participants With Best Response in the First 2 Cycles|The number of participants with Best tumor response in the first 2 cycles. Partial Response (PR): At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the BSD. Progression is defined as At least one of the following must be true:a. At least one new malignant lesion, which also includes any lymph node that was normal at baseline (< 1.0 cm short axis) and increased to ≥ 1.0 cm short axis during follow-up. b. At least a 20% increase in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the MSD. In addition, the PBSD must also demonstrate an absolute increase of at least 0.5 cm from the MSD.Stable Disease (SD): Neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD taking as reference the MSD.|Up to 56 days|Evaluable participants are included in this analysis.|||Participants|||Count of Participants
2639113|NCT01767636|Secondary|Overall Survival|Overall survival is defined as the time from study registration to death date.|Up to 2 years|Evaluable participants are included in this analysis.|||months||90% Confidence Interval|Median
2639148|NCT01767415|Secondary|Absence of Complications After Injection|Assessment of Post-operative Clinical Course & Complications|30 days||||Participants|||Count of Participants
2639149|NCT01767415|Primary|Extent of Resection|Evaluation of the extent of resection of the tumor following the indigo carmine infusion to the tumor.|48 hours|intraoperative stereotactic injection of indigo carmine at the tumor margins|||percentage of tumor resected||Full Range|Mean
2639114|NCT01767636|Secondary|Progression-free Survival|Kaplan-Meier curve will be used to estimate progression-free survival time. Progression is defined as At least one of the following must be true:a. At least one new malignant lesion, which also includes any lymph node that was normal at baseline (< 1.0 cm short axis) and increased to ≥ 1.0 cm short axis during follow-up. b. At least a 20% increase in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the MSD. In addition, the PBSD must also demonstrate an absolute increase of at least 0.5 cm from the MSD.|From registration to the earliest date documentation of disease progression or death, assessed up to 2 years|Evaluable participants are included in this analysis.|||months||90% Confidence Interval|Median
2639115|NCT01767636|Secondary|Number of Participants Experiencing at Least One Toxicity|Number of participants experiencing at least one toxicity defined as a grade 3 or higher adverse event deemed at least possible related to treatment.|Up to 2 years|Evaluable participants are included in this analysis.|||Participants|||Count of Participants
2639116|NCT01767636|Primary|Overall Survival Rate at 12 Months|Overall survival rate at 12 months is defined as the percentage of participants who are alive at 12 months.|12 months|Evaluable participants are included in this analysis.|||percentage of participants||90% Confidence Interval|Number
2639117|NCT01767597|Primary|Percentage of Patients Appropriately Seeking Care|"Subjects who are considered required to seek further care are as follows:~those who need HBV vaccination (non-immunized)~those who are infected with hepatitis B virus (infected)~Of these patients, subjects who have achieved appropriate care are considered as follows:~non immunized subjects who have initiated HBV vaccination sequence (vaccinated)~infected subjects who seek health care at a specialized center, allowing to quantify the severity of liver-related disease (infected with care)~The percentage of patients appropriately seeking care will be then calculated by the following formula:~((nb Vaccinated + nb infected with care) / (nb non-immunized + nb infected))*100"|6 months|Only participants needing further medical intervention were included in analysis: non-immunized (HBsAg negative, anti-HBc antibody negative, anti-HBs antibody negative) or infected (HBsAg positive).|||percentage of participants|||Number
2639118|NCT01767519|Secondary|Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1|The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the social limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized|||Scores on a Scale||Standard Deviation|Mean
2639119|NCT01767519|Secondary|Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1|The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the role limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized|||Scores on a Scale||Standard Deviation|Mean
2639120|NCT01767519|Secondary|Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1|Nocturia episodes are measured over a 3 day diary prior to each visit in Treatment Cycle 1. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized|||Nocturia Episodes||Standard Deviation|Mean
2639121|NCT01767519|Secondary|Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1|The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized|||Micturition Episodes||Standard Deviation|Mean
2639122|NCT01767519|Secondary|Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1|A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing 'greatly improved' or 'improved.'|Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized|||Percentage of Patients||95% Confidence Interval|Number
2639123|NCT01767519|Primary|Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period and compared to baseline to determine 100% reduction in episodes.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized|||Percentage of Patients|||Number
2639124|NCT01767519|Primary|Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1|Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Study Baseline, Week 12|Intent-to-Treat: includes all patients according to the group to which they are randomized|||Incontinence Episodes||Standard Deviation|Mean
2639125|NCT01767506|Secondary|The Mean of the Prevalence of Active Trachoma (TF) in Communities in Both Arms.|"Model the risk of active trachoma in intervention and control communities. We used the mean % and 95 % confidence interval as they present for a variable to describe the center of the population the sample represents and the precision of the estimate of that center.~If the variable is normally distributed in the population, the probability is 95% that the true mean falls in the 95% confidence interval."|Baseline only|The trial was conducted at the community level|||community|community|95% Confidence Interval|Mean
2639128|NCT01767467|Secondary|Mean Geometric Increase (MGI) of Anti-gE Antibody ELISA Concentrations|MGI was tabulated per study group and HZ confirmed/non-confirmed status. MGI was defined as the Geometric mean of the within subject ratios of the post-vaccination reciprocal anti-gE concentration to the Month 0 reciprocal anti-gE concentration.|At Month 2|This analysis was performed on the Cohort for correlate of protection, which included subjects from the Total vaccinated cohort receiving 2 vaccine doses and having no confirmed HZ-case before the Month 2 blood sampling, only on the subjects with available results at Month 2.|||Ratio||95% Confidence Interval|Geometric Mean
2639129|NCT01767467|Secondary|Geometric Mean Concentrations (GMCs) of Anti-gE Antibodies|GMCs of anti-gE antibodies were tabulated per study group and HZ confirmed/non-confirmed status and expressed in milli-international units per milliliter (mIU/mL).|At Months 0 and 2|This analysis was performed on the Cohort for correlate of protection, which included subjects from the Total vaccinated cohort receiving 2 vaccine doses and having no confirmed HZ-case before the Month 2 blood sampling.|||mIU/ml||95% Confidence Interval|Geometric Mean
2639130|NCT01767467|Secondary|Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology|From first vaccination at Month 0 up to study end at Month 13|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered.|||Participants|||Count of Participants
2639131|NCT01767467|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|A Serious adverse event (SAE) is any untoward medical occurrence that result in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Related = SAEs assessed by the investigator as causally related to the study vaccination|From first vaccination at Month 0 up to study end at Month 13|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered.|||Participants|||Count of Participants
2639132|NCT01767467|Secondary|Vaccine Response Rates (VRR) for gE-specific CD4 [2+] T-cells, Expressing at Least 2 Activation Markers|"Among markers expressed were IFN-γ, IL-2, TNF-α and CD40L, as determined by in vitro ICS. Vaccine response was defined as:~For initially subjects with pre-vaccination T-cell frequencies below the threshold, at least a 2-fold increase as compared to the threshold (2x<320> Events/106 CD4+ T cells).~For initially subjects with pre-vaccination T-cell frequencies above the threshold, at least a 2-fold increase as compared to pre-vaccination T-cell frequencies."|At Months 1, 2 and 13|The analysis was performed on the adapted ATP cohort for Cell Mediated Immunity (CMI), which included all evaluable subjects included in the ATP cohort for Humoral immunogenicity analyses and included in the CMI sub-cohort.|||Percentage||95% Confidence Interval|Number
2639133|NCT01767467|Secondary|Frequency of gE -Specific Cluster of Differentiation 4 (CD4) [2+] T-cells Expressing at Least 2 Activation Markers|Among markers expressed were interferon-gamma (IFN-γ), interleukin-2 (IL-2), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 ligand (CD40L), as determined by in vitro intracellular cytokine staining (ICS).|At Months 0, 1, 2 and 13|The analysis was performed on the adapted ATP cohort for Cell-Mediated Immunogenicity (CMI), which included all evaluable subjects included in the ATP cohort for Humoral immunogenicity analyses and included in the CMI sub-cohort.|||CD4 [2+] T-cells/million T-cells||Standard Deviation|Mean
2639134|NCT01767467|Secondary|Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations|Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by ELISA. Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 ≥ 4 fold the cut-off for anti-gE (4x97 mIU/mL). For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre -vaccination antibody concentration. Vaccine response was measured in all subjects.|At Months 1, 2 and 13|The analysis was performed on the adapted ATP cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 13 visit.|||Percentage||95% Confidence Interval|Number
2639135|NCT01767467|Secondary|Anti-gE Antibody Concentrations|Antibody concentrations were determined by ELISA, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). This parameter was assessed in all vaccinated subjects.|At Months 0, 1, 2 and 13|The analysis was performed on the adapted ATP cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 13 visit.|||mIU/mL||95% Confidence Interval|Geometric Mean
2639136|NCT01767467|Secondary|Time to Occurrence of Any Confirmed HZ Case|"Time to occurrence of any confirmed HZ case is expressed in terms of incidence rate of subjects with at least one event. Hence, person-year rate = number of episodes (n)/ sum of follow-up period (censored at the first occurrence of an event) expressed in years (T[year)]). Follow-up period starts Day 1 of vaccination.~Any clinically suspected case of HZ (defined as (1) a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations), or a vesicular rash suggestive of Varicella Zoster Virus (VZV) infection regardless of the distribution, and no alternative diagnosis; or (2) a clinical presentation (symptoms and/or signs) and specific laboratory findings suggestive of VZV infection in the absence of characteristic HZ or VZV rash.) The endpoint is confirmed in two ways: (1) By Polymerase Chain Reaction (PCR) or (2) By the HZ Ascertainment Committee. The PCR is used as primary classification method."|From Month 0 until study end (Month 13)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered.|||Person-year rate||95% Confidence Interval|Number
2639137|NCT01767467|Secondary|Anti-gE Antibody Concentrations|Antibody concentrations were determined by ELISA, presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).This parameter was assessed in subjects with haematologic malignancies, excluding subjects with Non-Hodgkin B-cell Lymphoma.|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.|||mIU/mL||95% Confidence Interval|Geometric Mean
2639138|NCT01767467|Secondary|Vaccine Response Rate (VRR) for Anti-gE Antibody Concentrations|Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by ELISA. Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL). For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre -vaccination antibody concentration. This analysis was performed on subjects with haematologic malignancies, excluding subjects with Non-Hodgkin B-cell Lymphoma.|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.|||Percentage||95% Confidence Interval|Number
2639139|NCT01767467|Primary|Number of Subjects Reporting Any and Related Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Related = pIMds assessed by the investigator as causally related to the study vaccination|From first vaccination up to 30 days post last vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered.|||Participants|||Count of Participants
2639140|NCT01767467|Primary|Number of Subjects With Serious Adverse Events (SAEs)|A Serious adverse event (SAE) is any untoward medical occurrence that result in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Related = SAEs assessed by the investigator as causally related to the study vaccination|From first vaccination up to 30 days post last vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered.|||Participants|||Count of Participants
2639141|NCT01767467|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study. It also included any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|Within the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all all subjects with at least one vaccine dose administered.|||Participants|||Count of Participants
2639142|NCT01767467|Primary|Number of Days With Solicited General Symptoms|Solicited general symptoms: fatigue, gastrointestinal symptoms, headache, myalgia, shivering, temperature and their number of days were recorded after each vaccination dose.|Withing the 7-day (Day 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered, who had their symptom sheets completed.|||Days||Inter-Quartile Range|Median
2639143|NCT01767467|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and fever [defined as oral, axillary or tympanic route measured temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered, who had their symptom sheets completed.|||Participants|||Count of Participants
2639144|NCT01767467|Primary|Number of Days With Solicited Local Symptoms|Solicited local symptoms: pain, redness, swelling and their number of days were recorded after each vaccination dose.|Within the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered, who had their symptom sheets completed.|||Days||Inter-Quartile Range|Median
2639145|NCT01767467|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administered, who had their symptom sheets completed.|||Participants|||Count of Participants
2639146|NCT01767467|Primary|Adjusted Geometric Mean Concentration of Anti-gE Antibodies|The Adjusted geometric mean concentration was measured in all subjects excluding those with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, who received the full vaccination course, complied with the protocol and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.|||mIU/mL||95% Confidence Interval|Geometric Mean
2639147|NCT01767467|Primary|Vaccine Response Rates (VRR) for Anti-glycoprotein E (Anti-gE) Antibody Concentrations|"Vaccine response rate refers to the percentage of subjects with a vaccine response, as determined by Enzyme-Linked Immunosorbent Assay (ELISA). Vaccine response was defined as: For initially seronegative subjects, antibody concentration at Month 2 greater than or equal to (≥) 4 fold the cut-off for Anti-gE [4x97 milli-international units per milliliter (mIU/mL)]. For initially seropositive subjects, antibody concentration at Month 2 ≥ 4 fold the pre-vaccination antibody concentration.~This analysis was performed on subjects with haematologic malignancies excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia."|At Month 2|The analysis was performed on the According-to-Protocol (ATP) cohort for Humoral immunogenicity, which included all subjects who met all eligibility criteria, who received the full vaccination course, complied with the protocol and and for whom data concerning immunogenicity outcome measures were available up to the Month 2 visit.|||Percentage||95% Confidence Interval|Number
2639150|NCT01767376|Secondary|Number of Subjects With Serious Adverse Events SAE(s)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the study (Month 0 up to Month 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2639151|NCT01767376|Secondary|Number of Subjects With Unsolicited Adverse Events AE(s)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2639152|NCT01767376|Secondary|Number of Subjects With New Onset of Chronic Diseases (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|Throughout the study (Month 0 up to Month 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2639153|NCT01767376|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Results are presented across doses.|During the 4-day (Days 0-3) period following each vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2639154|NCT01767376|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Results are presented across doses, after each vaccination (with Nimenrix, Boostrix, total).|During the 4-day (Days 0-3) following each vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2639155|NCT01767376|Secondary|Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Concentrations|"Booster response to the pertussis components is defined as:~For initially seronegative subjects, antibody concentration ≥ 4*cut_off (IU/mL) at one month post-vaccination;~For initially seropositive subjects with pre-vaccination antibody concentration < 4*cut_off (IU/mL) : antibody concentration at one month post-vaccination ≥ 4 fold the pre-vaccination antibody concentration;~For initially seropositive subjects with pre-vaccination antibody concentration ≥ 4*cut_off (IU/mL) : antibody concentration at one month post-vaccination ≥ 2 fold the pre-vaccination antibody concentration."|One month after Boostrix vaccination (i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.|||Participants|||Count of Participants
2639156|NCT01767376|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value|The reference cut-off value of the assay was an antibody concentration ≥ 5.0 ELISA units per milliliter (EL.U/mL)|Prior to (i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group) and one month after Boostrix vaccination (i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.|||Participants|||Count of Participants
2639157|NCT01767376|Secondary|Anti-T Antibody Concentrations|The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).|Prior to (i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group), one month after Nimenrix vaccination and one month after Boostrix vaccination|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.|||IU/mL||95% Confidence Interval|Geometric Mean
2639158|NCT01767376|Secondary|Anti-D Antibody Concentrations|The antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).|Prior to (PRE i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group) and one month after Boostrix vaccination (POST i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.|||IU/mL||95% Confidence Interval|Geometric Mean
2639159|NCT01767376|Secondary|Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies|"rSBA vaccine response for serogroups A, C, W-135 and Y was defined as:~For initially seronegative subjects (pre-vaccination titer below the cut-off of 1:8): number of subjects with rSBA antibody titers ≥ 1:32 one month after vaccination.~For initially seropositive subjects (pre-vaccination titer ≥ 1:8): number of subjects with rSBA antibody titers at least four times the pre-vaccination antibody titers, one month after vaccination."|One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.|||Participants|||Count of Participants
2639160|NCT01767376|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values|The reference cut-off values of the assay were rSBA-Men antibody concentrations ≥ 1:128 and ≥ 1:8.|Prior to (i.e. Month 0 for Nimenrix+Boostrix and Nimenrix Groups and Month 1 for Boostrix Group) and one month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.|||Participants|||Count of Participants
2639161|NCT01767376|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|The antibody concentrations were tabulated as adjusted geometric mean concentrations (GMCs) and expressed as international units per millilitre (IU/mL). The primary outcome results only refer to Nimenrix+Boostrix Group and Boostrix Group|One month after Boostrix vaccination (i.e. Month 1)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.|||IU/mL||95% Confidence Interval|Geometric Mean
2639162|NCT01767376|Primary|Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off Value|The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). The reference cut-off value was an antibody concentration ≥ 1 IU/mL. The primary outcome results only refer to Nimenrix+Boostrix Group and Boostrix Group.|One month after Boostrix vaccination (i.e. Month 1)|The analysis was performed on the ATP cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.|||Participants|||Count of Participants
2639163|NCT01767376|Primary|Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA)|The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The primary outcome results only refer to Nimenrix+Boostrix Group and Nimenrix Group.|One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity will included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccine dose.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2639164|NCT01767285|Other Pre-specified|Patient Satisfaction|To identify differences in satisfaction with birth control method between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.|12 months|Participants who completed the 12 month patient satisfaction assessment.|||participants|||Number
2639165|NCT01767285|Other Pre-specified|Pregnancy Rate|To identify differences pregnancy rates between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.|12 months|all participants who completed the 12 month follow up visit|||participants|||Number
2639166|NCT01767285|Other Pre-specified|Continuation of Breastfeeding|To identify differences in continuation of breast-feeding at 6 months between women who have immediate versus delayed (6 weeks) postpartum Implanon® placement.|6 months|Participants who completed the 6 month assessment.|||participants|||Number
2639167|NCT01767285|Secondary|Continuation Rate|To identify a difference in continuation rates of Implanon® at one year between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit.|6 months|Participants who completed the 6 month assessment.|||participants|||Number
2639168|NCT01767285|Secondary|Rate of Intercourse|To identify differences in the rates of intercourse prior to the 6-week postpartum visit.|6 weeks|Participants who completed the 6 week assessment.|||participants|||Number
2639169|NCT01767285|Primary|Continuation Rate|To identify a difference in continuation rates of Implanon® between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit.|1 year|Participants who completed the 1 year phone visit were included in analysis.|||participants|||Number
2639170|NCT01767194|Other Pre-specified|Overall Response|The proportion of patients achieving each type of overall response (complete response, partial response, stable disease, progressive disease) will be calculated according to the International Neuroblastoma Response Criteria (INRC).|Up to the first 6 cycles of treatment|||||||
2639171|NCT01767194|Other Pre-specified|Ability to Maintain Intended Treatment Without a Dose Reduction or Going Off Protocol Therapy for Toxicity|The proportion of patients who required a dose modification or went off protocol therapy for toxicity will be calculated for each treatment group.|Up to 1 year|||||||
2639172|NCT01767194|Other Pre-specified|Occurrence of Unacceptable Toxicities|The proportion of patients with at least one grade 3 or higher toxicity, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.|Up to 1 year|||||||
2639173|NCT01767194|Other Pre-specified|Overall Survival|Kaplan-Meier method will be used to estimate overall survival. Overall survival is defined as the time from enrollment on the study until death.|Up to 3 years|||||||
2639174|NCT01767194|Other Pre-specified|Progression-free Survival|Kaplan-Meier method will be used to estimate progression-free survival. Progression-free survival will be defined as the time from enrollment to relapse, progressive disease, or death attributable to tumor or treatment.|Up to 3 years|||||||
2639181|NCT01767116|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period.|Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-treatment)|All randomized participants who received at least 1 dose of study drug (ITT population) with HCV RNA < LLOQ at the final treatment visit and completed treatment.|||percentage of participants|||Number
2639595|NCT01763905|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639175|NCT01767194|Primary|Percentage of Patients in the Dinutuximab Arm Who Are Responders|Percentage of patients who are responders to therapy with dinutuximab will be tabulated, including a 95% confidence interval on the response rate. Responders are defined as patients who achieve a best overall response of complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Neuroblastoma Response Criteria (INRC). Per INRC: CR= Disappearance of all target lesions. No evidence of tumor at any site; VGPR= >90% decrease of disease measurement for CT/MRI target lesions. All pre-existing bone lesions with CR by MIBG; MIBG scan can be stable disease (SD) or CR in soft tissue lesions corresponding to lesions on CT/MRI. CR in bone marrow. No new sites of tumor; PR= ≥30% decrease in disease measurement for CT/MRI target lesions. Bone marrow with CR. MIBG with either PR/CR in bone lesions; MIBG may be SD or CR in soft tissue lesions corresponding to lesions on CT/MRI. Homovanillic acid (HVA)/ Vanillylmandelic acid (VMA) may still be elevated.|Up to the first 6 cycles of treatment|Includes all eligible patients either randomized or non-randomly assigned to Arm II. Of the 54 participants assigned to Arm II, 1 was ineligible and not included in the analysis. The remaining 53 eligible participants are included in the analysis, 17 randomized and 36 non-randomly assigned to Arm II.|||Percentage of patients||95% Confidence Interval|Number
2639176|NCT01767194|Primary|Percentage of Randomized Patients Who Are Responders|The percentage of patients who are responders will be tabulated, including a 95% confidence interval on the response rate. Responders are defined as patients who achieve a best overall response of complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Neuroblastoma Response Criteria (INRC). Per INRC: CR= Disappearance of all target lesions. No evidence of tumor at any site; VGPR= >90% decrease of the disease measurement for CT/MRI target lesions. All pre-existing bone lesions with CR by MIBG; MIBG scan can be stable disease (SD) or CR in soft tissue lesions corresponding to lesions on CT/MRI. CR in bone marrow. No new sites of tumor; PR= >=30% decrease in the disease measurement for CT/MRI target lesions. Bone marrow with CR. MIBG with either PR/CR in bone lesions; MIBG may be SD or CR in soft tissue lesions corresponding to lesions on CT/MRI. Homovanillic acid (HVA)/Vanillylmandelic acid (VMA) may still be elevated.|Up to the first 6 cycles of treatment|Includes all eligible patients randomly assigned to Arm I or Arm II. Of the 19 participants randomized to Arm I, one was ineligible and not included in the analysis. Of the 54 participants assigned to Arm II, 1 was ineligible and 36 were non-randomly assigned, and not included in the analysis.|||Percentage of patients||95% Confidence Interval|Number
2639177|NCT01767155|Secondary|Compare Efficacy Based on Clinical Benefit Rate (CBR).|"Clinical benefit was defined as having stable disease (SD) or better lasting for at least 9 weeks. The CBR was analyzed using the same methods for the ORR analyses. The analysis of CBR (CR+PR+SD) was performed in the ITT (intention-to-treat) population.~CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) was to have a reduction in the short axis to <10 mm.~PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~All responses were confirmed at least 4 weeks after the initial response was observed. Tumor assessments occurred every 3 cycles (± 7 days) during ongoing treatment then every 3 months (± 7 days) thereafter while the patient was on study. The last assessment occurred either when progression was confirmed or when approximately 384 randomized patients had died."|3 years||||Participants|||Count of Participants
2639178|NCT01767155|Secondary|Compare Efficacy Based on Progression-free Survival (PFS).|"Progression-free survival (PFS): days between randomization and the date of documented progression or death for any cause that occurred up to the end of the study. For patients whose progression status could not be determined, their PFS data was censored for the last adequate progression assessment date that the patient was confirmed to have no progression.~Response and progression were to be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (uni-dimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes were to be used.~During ongoing treatment, patients were to be re-evaluated for response every 3 cycles (i.e. every 9 weeks).~A subsequent scan was obtained no earlier than 4 weeks following the initial documentation of an objective status of either complete response (CR) or partial response (PR)."|During ongoing treatment: response evaluation every 3 cycles. For patients gone of treatment: re-assessment every 12 weeks.|The population analyzed is the mITT. PFS was analyzed in the subset of patients from mITT that have CR, PR or stable disease (SD) as best overall response.|||Participants|||Count of Participants
2639179|NCT01767155|Secondary|Compare Efficacy Based on Objective Response Rate (ORR).|"The ORR was defined as the sum of the Complete Response (CR) and Partial Response (PR).~CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) was to have a reduction in the short axis to <10 mm.~PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~All responses were confirmed at least 4 weeks after the initial response was observed. Tumor assessments occurred every 3 cycles (± 7 days) during ongoing treatment then every 3 months (± 7 days) thereafter while the patient was on study. The last assessment occurred either when progression was confirmed or when approximately 384 randomized patients had died."|3 years||||Participants|||Count of Participants
2639180|NCT01767155|Primary|Compare the Overall Survival (OS) of Patients Treated With AEZS-108 to the OS of Patients Treated With Doxorubicin.|"Overall survival was defined as the elapsed time from randomization to death from any cause. For surviving patients, follow-up was to be censored at the date of last contact.~The final analysis, which was event-based, was conducted after approximately 384 randomized patients had died.~A log-rank test with an overall two sided Type I Error rate of 0.05 after taking the interim analyses into account was used to compare OS between the two treatment arms via a SAS (Statistical Analysis System) LIFETEST procedure. Kaplan Meier estimates were used to calculate median OS and the 95% confidence interval (CI) of the median OS. The proportion of patients alive at 6 and 12 months (from randomization date) and the 95% CIs for these estimated proportions were calculated."|From randomization to death from any cause. During ongoing treatment: response evaluation every 3 cycles. For patients gone of treatment: re-assessment every 12 weeks.||||participants|||Number
2639252|NCT01766076|Primary|Percentage Change in Immune Activation Levels After 12 Weeks of Atorvastatin 80mg Daily|Immune activation was measured by co-expression of CD38 and HLADR on CD4 T-cells (CD4+CD38+HLADR+) Mean percentage change at 12 weeks was calculated|12 weeks|There was no cross-over or carry-over effect (the sequence did not matter), so we present data for 30 patients for their 12 weeks exposure to atorvastatin|||percentage change in activated T-cells||Inter-Quartile Range|Median
2639182|NCT01767116|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12|All randomized participants who received at least 1 dose of study drug (ITT population).|||percentage of participants|||Number
2639183|NCT01767116|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Superiority Analyses of Each Treatment Arm Compared to Historical Rate|"The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.~The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b treated with telaprevir and pegIFN/RBV."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (ITT population); participants with missing data were counted as non-responders.|||percentage of particpants|||Number
2639184|NCT01767116|Secondary|Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment|The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.|Baseline (Day 1) and Week 12 (End of Treatment)|All randomized participants who received at least 1 dose of study drug (ITT population) and had hemoglobin ≥ LLN reference range at baseline.|||percentage of participants|||Number
2639185|NCT01767116|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analysis of ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV Compared With ABT-450/r/ABT-267 and ABT-333, Plus RBV|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.~The secondary endpoint was the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (ITT population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
2639186|NCT01767116|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.~The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b infection treated with telaprevir and peginterferon/RBV (pegIFN)."|12 weeks after last dose of study drug|All randomized participants who received at least 1 dose of study drug (intent-to-treat [ITT] population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
2639187|NCT01767103|Primary|Fe% for Urine Deferiprone and Deferiprone 3-O-glucuronide|"Cumulative fraction of Ferriprox dose excreted in urine as deferiprone or deferiprone 3-O-glucuronide. Urine samples were collected at the intervals of -2 to 0 hours pre-dose, and 0-2, 2-4, 4-8, 8-12 ,and 12- 24 hours post-dose.~Note: For unknown reasons, the urine samples for one subject in the moderate hepatic failure group had low or zero volume and there were no measurable levels of deferiprone or its metabolite in any of the samples. Accordingly, the urine PK results were derived both with and without this subject's data, and are here presented without them (i.e., N=6 rather than 7)."|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter. The data of one subject in the moderate hepatic failure group were dropped due to low or zero volume of urine samples.|||percentage of dose excreted in urine||Standard Deviation|Mean
2639188|NCT01767103|Primary|CumAe for Urine Deferiprone and Deferiprone 3-O-glucuronide|"Cumulative amount of deferiprone and deferiprone 3-O-glucuronide excreted in the urine. Urine samples were collected at the intervals of -2 to 0 hours pre-dose, and 0-2, 2-4, 4-8, 8-12 ,and 12- 24 hours post-dose.~Note: For unknown reasons, the urine samples for one subject in the moderate hepatic failure group had low or zero volume and there were no measurable levels of deferiprone or its metabolite in any of the samples. Accordingly, the urine PK results were derived both with and without this subject's data, and are here presented without them (i.e., N=6 rather than 7)."|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter. The data of one subject in the moderate hepatic failure group were dropped due to low or zero volume of urine samples.|||mg||Standard Deviation|Mean
2639189|NCT01767103|Primary|T1/2 for Serum Deferiprone and Deferiprone 3-O-glucuronide|T1/2 was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal hepatic function, mild hepatic impairment, or moderate hepatic impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter|||hour||Standard Deviation|Mean
2639190|NCT01767103|Primary|AUC0-∞ for Serum Deferiprone and Deferiprone 3-O-glucuronide|AUC (area under the curve) from zero to infinity was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal hepatic function, mild hepatic impairment, or moderate hepatic impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter|||ug*hr/mL||Standard Deviation|Mean
2639612|NCT01763866|Secondary|Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12||Week 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2639191|NCT01767103|Primary|Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Tmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal hepatic function, mild hepatic impairment, or moderate hepatic impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter|||hour||Full Range|Median
2639192|NCT01767103|Secondary|Safety and Tolerability of Ferriprox in Subjects With or Without Hepatic Impairment.|The number of participants who experienced adverse events following a single dose of Ferriprox, between the time of dosing and the follow-up visit (including any changes of clinical significance in physical examinations, vital signs, 12-lead ECG, and clinical laboratory tests).|Time of dosing until 48 hours post-dose|The Safety Analysis Set consisted of all subjects who received study medication and had at least one safety assessment|||participants|||Number
2639193|NCT01767103|Primary|Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide|Cmax was assessed over a 24-hour interval for analyses of deferiprone and its 3-O-glucuronide metabolite in subjects with normal hepatic function, mild hepatic impairment, or moderate hepatic impairment. Blood samples were obtained prior to dosing and at 0.25, 0.50, 0.75, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 9, 12, 16, and 24 hours post-dose.|24-hour interval|The PK Analysis Set consisted of all subjects who had sufficient data to derive at least one PK parameter|||ug/mL||Standard Deviation|Mean
2639194|NCT01767064|Primary|Inappropriate Antibiotic Prescribing for Patients With Acute Respiratory Infections (ARI)|Using data from electronic health records, we will calculate clinician antibiotic prescribing rates for antibiotic-inappropriate ARI diagnoses: acute nasopharyngitis (ICD-9 460.x), acute laryngitis without obstruction (465.8), acute laryngopharyngitis (465.0), acute bronchitis (466.x), acute upper respiratory infections of other multiple sites (465.8), acute upper respiratory infections not otherwise specified (465.9), bronchitis not specified as acute or chronic (490.x), non-streptococcal pharyngitis (462.xx), and influenza with other respiratory manifestations (487.1). To control for temporal trends in antibiotic prescribing and provider-fixed effects, we will fit a logistic mixed effects model that predicts inappropriate antibiotic prescribing as a function of study arm and an indicator for baseline versus intervention period (a difference-in-differences regression).|up to 12 months post intervention|clinicians|||inappropriate prescribing events||95% Confidence Interval|Number
2639195|NCT01766921|Secondary|The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, three weeks after receiving two injections of either low dose or high dose aH5N1c vaccine according to the CHMP criterion.~Seroconversion is defined as a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.~The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion is >30%."|Day 22, day 43 and day 387|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
2639196|NCT01766921|Secondary|Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain|"Immunogenicity was assessed in terms of percentage of subjects achieving HI titers >40, three weeks after second vaccination with aH5N1c according to the CHMP criterion.~The European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >60%."|Day 1, day 22, day 43 and day 387.|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
2639197|NCT01766921|Secondary|Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine.|"Immunogenicity was measured as the GMR. The ratio of postvaccination to prevaccination HI geometric mean titers (GMTs) is reported.~The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criterion if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is >2.0 for subjects >60 years of age."|Day 1; day 22; day 43 and day 387|Analysis was done on the FAS.|||Ratio||95% Confidence Interval|Geometric Mean
2639198|NCT01766921|Primary|Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.|Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with aH5N1c vaccine|Day 1 through day 387 after any vaccination|Analysis was done unsolicited safety population, i.e. subjects in the exposed set with unsolicited AE data.|||Number of subjects|||Number
2639199|NCT01766921|Primary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination.|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.|From day 1 through day 7 after any vaccination.|Analysis was done on the solicited safety population, i.e. All subjects in the exposed set with solicited (local/systemic) AE data..|||Number of subjects|||Number
2639200|NCT01766921|Primary|The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.|"Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion.~Seroconversion is defined as, a postvaccination titer ≥40 in subjects with a prevaccination HI titer <10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer.~The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 30%."|Three weeks after 2nd vaccination (day 43)|This analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
2639236|NCT01766401|Primary|Change in Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score|The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.|Baseline to Week 8|The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of the HAM-A.|||Score on Scale||Standard Deviation|Mean
2639201|NCT01766921|Primary|The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain.|"The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion.~The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 60%."|Baseline (day 1) and Three weeks after 2nd vaccination (day 43)|Analysis was done on the Full Analysis Set (FAS) i.e., subjects who actually receive at least one dose of study vaccination and provide at least one evaluable serum sample both before (baseline) and after vaccination.|||Percentages of subjects||95% Confidence Interval|Number
2639202|NCT01766817|Secondary|Average Concentration of BMS -986020 at Steady State (Css[Avg])|Css (avg) is the average concentration at steady state.|Day 7|Evaluable PK population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable at this time point.|||ug/L||Geometric Coefficient of Variation|Geometric Mean
2639203|NCT01766817|Secondary|Apparent Oral Clearance (CLF/F) of BMS -986020|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 1 and Day 7|Evaluable PK population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable at each time point.|||Liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2639204|NCT01766817|Secondary|Area Under the Plasma Concentration-time Curve Over 12 Hours Post-dose AUC(0-12) of BMS -986020|AUC(0-12) is the area under the plasma concentration time curve over 12 hours post-dose.|Day 1 and Day 7|Evaluable PK population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable at each time point.|||ug*h/L||Geometric Coefficient of Variation|Geometric Mean
2639205|NCT01766817|Secondary|Area Under the Concentration Time Curve in One Dosing Interval of BMS -986020 in at Steady-state|AUC(TAU) is the area under the concentration time curve in one dosing interval in at steady-state.|Day 1 and Day 7|Evaluable PK population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable at each time point.|||ug*h/L||Geometric Coefficient of Variation|Geometric Mean
2639206|NCT01766817|Secondary|Accumulation Index (AI) of BMS-986020|AI is the ratio of area under the concentration time curve in one dosing interval in (AUC[TAU]) at steady-state to AUC(TAU) after the first dose.|Day 7|Evaluable PK population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable this outcome measure.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2639207|NCT01766817|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986020|Tmax is defined as the maximum observed plasma concentration.|Day 1 and Day 7|Evaluable PK population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable at each time point.|||hours (h)||Full Range|Median
2639208|NCT01766817|Secondary|Maximum Observed Plasma Concentration (Cmax) BMS-986020|Cmax is defined as the maximum observed plasma concentration.|Day 1 and Day 7|Evaluable pharamcokinetic (PK) population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable at each time point.|||microgram per liter (ug/L)||Geometric Coefficient of Variation|Geometric Mean
2639209|NCT01766817|Secondary|Number of Participants With Definite or Probable Acute Exacerbation (AEx) of Idiopathic Pulmonary Fibrosis (IPF)|Acute IPF exacerbations is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. Exacerbations of IPF were adjudicated as definite (>=1 AEx) and Probable. Investigators were asked to make the diagnosis of acute exacerbation of IPF on the basis of subjective worsening over 30 days or less, new bilateral radiographic opacities, and the absence of infection or another identifiable etiology. The final diagnosis, however, was confirmed by the study medical monitor.|Upto Day 210|ITT population included all randomized participants.|||Participants|||Count of Participants
2639210|NCT01766817|Secondary|Mean Change From Baseline in Carbon Monoxide Diffusing Capacity (DLCO) to Week 26|DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. Participant breathe in (inhale) air containing a very small, harmless amount of a tracer gas, such as carbon monoxide. Participant hold the breath for 10 seconds, then rapidly blow it out (exhale). The exhaled gas was tested to determine how much of the tracer gas was absorbed during the breath. DLCO, both uncorrected and corrected for hemoglobin in milliliter per minute per millimeter of mercury (mL/min/mmHg) was assessed.|Baseline, Week 26|ITT population included all randomized participants.Here 'n' 'number analyzed' signifies number of participants who were evaluable for each category.|||mL/min/mmHg||Standard Error|Least Squares Mean
2639211|NCT01766817|Secondary|Number of Participants With Death or Respiratory Hospitalization or 10 Percent (%) Decline in Absolute Volume of FVC or 25-Meter Loss in 6-Minute Walk Distance (6MWD)|Number of participants with death or respiratory hospitalization or 10% decline in absolute volume of FVC or 25 meter loss in 6MWD over time were reported.|Upto Day 210|Safety Population included all enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2639212|NCT01766817|Secondary|Number of Participants With Death or Non-Elective Hospitalization|Time to death or non-elective hospitalization was defined as the elapsed time (days) from randomization to the date of death or the first non-elective hospitalization.|Upto Day 210|Safety population included all enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2639237|NCT01766336|Primary|Number of Participants Experiencing Treatment Emergent Adverse Events|To evaluate the safety and tolerability of ELND005 treatment with up to 36 weeks exposure, in Moderate to Severe AD patients with agitation and aggression.|36 weeks||||participants|||Number
2639238|NCT01766310|Other Pre-specified|Prevalence of Hyperhomocysteinemia|prevalence of hyperhomocysteinemia in Thai obese children|8 weeks||||participants|||Number
2639239|NCT01766310|Secondary|Serum Vitamin B12 Level|correlation between serum vitamin B12 and plasma homocysteine level|8 weeks|||||||
2639240|NCT01766310|Secondary|Serum Folate Level|correlation between serum folate and plasma homocysteine level|8 weeks|||||||
2639213|NCT01766817|Secondary|Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Study (MOS) 36-Item Short-Form Health Survey (SF-36) to Week 26|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the Aggregate Physical score of the SF-36. Items 5-8 primarily contribute to the Aggregate mental score of the SF-36. Scores on each item are summed and averaged. Range for Aggregate Physical Score : 0=worst to 100=best; and for Aggregate Mental Score: 0=worst to 100=best. Increases from baseline indicate improvement. Baseline included all testing done on Day -1 as well as predose on Day 1|Baseline, Week 26|ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for each category.|||Units on a scale||Standard Error|Least Squares Mean
2639214|NCT01766817|Secondary|Mean Change From Baseline in Forced Vital Capacity (FVC) to Week 26|FVC is is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry; and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of lungs after taking an inhaled bronchodilator medicine which is used to dilate bronchial (breathing) tubes. Baseline included all testing done on Day -1 as well as predose on Day 1|Baseline, Week 26|ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure.|||liters||Standard Deviation|Mean
2639215|NCT01766817|Secondary|Mean Change From Baseline in the University of California at San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score as a Measure of Dyspnea to Week 26|The UCSD SOBQ is a 24-item questionnaire developed to measure breathlessness on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. Baseline included all testing done on Day -1 as well as predose on Day 1. The total score ranges from 0 to 120, with higher scores indicating worse dyspnea.|Baseline, Week 26|ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure.|||Unit on a scale||Standard Deviation|Mean
2639216|NCT01766817|Secondary|Mean Change From Baseline in Six-minute Walk Test (6MWT) Distance to Week 26|The 6MWT measures the distance (in meters), a participant is able to walk in 6 minutes. This test measures the distance a person can walk quickly on a flat, hard surface in 6 minutes and reflects an individual's ability to perform daily physical activities. Baseline included all testing done on Day -1 as well as predose on Day 1|Baseline, Week 26|ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure.|||meters (m)||Standard Deviation|Mean
2639217|NCT01766817|Secondary|Geometric Mean Ratio (GMR) of Quantitative Lung Fibrosis (QLF) Score at Week 26 to Baseline|The QLF score itself ranges from 0 to 100%, where greater values represent a greater amount of lung fibrosis and are considered a worse health status. Hence smaller geometric mean ratios to baseline were considered favorable. Baseline included all testing done on Day -1 as well as predose on Day 1.|Baseline, Week 26|ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure.|||Ratio|||Number
2639218|NCT01766817|Primary|Change From Baseline in Forced Vital Capacity (FVC) Rate to Week 26|FVC is the is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry; and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes.|Baseline, Week 26|Intent-to-treat (ITT) population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure.|||liters (L)||Standard Deviation|Mean
2639219|NCT01766778|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death as an Assessment of Overall Safety and Tolerability|This analysis reported percentage patients with adverse events and patient discontinued from the study due to adverse events. Aslo, percentage of patients with serious adverse events and death was reported.|Month 12|Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication.|||Patients|||Number
2639220|NCT01766778|Secondary|Percentage of Overall Drug Compliance in 12 Months|The overall drug compliance (%) = (Observed Consumption / Expected Consumption) x 100% Where (Observed Consumption / Expected Consumption) = [1- (Number of missing tablets from all visits/(sum of Allocated Daily Dosage (in tablets) from all visits × No. of Days between the Date Dispensed and the Date Returned))]|Month 12|Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication. Patients who had reported dosing compliance were included in this analysis.|||Percentage of overall drug compliance||Standard Deviation|Mean
2639221|NCT01766778|Secondary|Percentage of Patients Achieving Good Glycemic Control|Blood samples were collected to analyze HbA1c. Good glycemic control is defined as patient achieving Hb1Ac < 7.0%. Percentage of patients who achieved HbA1c less than 7.0% at month 3, 6, 9 and 12 were reported for this endpoint.|Month 3, 6, 9, 12|Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication. 'n' indicates patients with HbA1c data in that time point.|||Percentage of patients|||Number
2639222|NCT01766778|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)|Blood samples were collected to analyze fasting plasma glucose. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model included terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by pre-existing hypertension. The variable selected for baseline adjustment was based on the lowest AIC.|Baseline, Month 3, 6, 9 and 12|Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication.|||mmol/L||Standard Error|Least Squares Mean
2639241|NCT01766310|Primary|Changes of Homocysteine Level|Mean difference of changes of homocysteine level between 2 treatment groups|8 weeks||||µmol/L||Standard Deviation|Mean
2639223|NCT01766778|Secondary|Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 3, 6, 9 and 12 (Based on MMRM Analysis)|HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c. Mixed Model of Repeated Measures (MMRM) was used to analyze this outcome. For the MMRM analysis, the model includes terms for treatment, period, treatment-by-period interaction and baseline value, and further adjusted by age, pre-existing hypertension and microvascular and macrovascular complications for diabetes mellitus. The variables selected for baseline adjustment were based on the lowest AIC.|Baseline, Month 3, 6, 9 and 12|Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication. .|||percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2639224|NCT01766778|Primary|Change of Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Month 12|HbA1c is an integrated measure of average glucose concentration in plasma in the last 2-3 months. Blood samples were collected to analyze HbA1c|Baseline, Month 12 (weeK 52)|Intent to treat (ITT) analysis set included all randomized patients who received at least one dose of study medication. Patients with both baseline and 12 month data were included in this analysis|||percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2639225|NCT01766713|Primary|Change in Liver Fat as Measured by MRI-PDFF||24 weeks|compared to baseline, end of treatment MRI-PDFF|||percentage of total fat||Standard Deviation|Mean
2639226|NCT01766466|Primary|Extent of Aggregation Response During Ticagrelor Treatment|"Blood samples were taken for platelet function studies to conduct pharmacodynamic assessments including LTA.~A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor.~Residual platelet reactivity (PR) (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response)."|Day 1 at 2.25, 2.5, 2.75, 3 and 4 hrs following initiation of cangrelor infusion||||percentage of platelet reactivity (PR)||Standard Deviation|Mean
2639227|NCT01766466|Primary|Extent of Preservation of Inhibitory Effect Compared With Effect Observed During Cangrelor Treatment After Ticagrelor|"A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor.~Residual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry (LTA). Residual platelet reactivity (PR) was measured in response to 20 µmol ADP at 300 seconds (final/terminal aggregation response)."|Day 5 at 1.0 and 2.0 hours after the initiation of cangrelor infusion||||percentage of platelet reactivity (PR)||Standard Deviation|Mean
2639228|NCT01766466|Primary|Extent of Preservation of Inhibitory Effect Compared With Effect Observed With Cangrelor Alone (at Timepoint 1, Either at 0.5 Hours or 1.25 Hours) or Ticagrelor Alone (Measured 5.25 Hours After Initiation of Cangrelor on Day 1)|A reference point was chosen for comparison and designated the first draw during the cangrelor infusion (0.5 hours or 1.25 hours) as the reference for the effect of cangrelor and designated the final draw on study Day 1 (5.25 hours, or 3.25 hours after cangrelor had been discontinued) as the reference for the effect of ticagrelor. Residual platelet reactivity (the extent of aggregation in the presence or absence of the study drugs) was examined for each of the endpoints using light transmittance aggregometry. Residual platelet reactivity (PR) was measured in response to 20 µmol adenosine diphosphate (ADP) at 300 seconds (final/terminal aggregation response).|Day 1 measures taken at 2 timepoints after cangrelor infusion start: 0.5 or 1.5 hrs (Timepoint 1) and 5.25 hrs (TImepoint 2)||||percentage of platelet reactivity (PR)||Standard Deviation|Mean
2639229|NCT01766440|Primary|AUC (0-12h) of Calcitriol Plasma Level|AUC (0-12h) of calcitriol plasma level at Day 14 (For subjects with a body weight of < 15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post dose PK samples. For subjects with a body weight of ≥ 15 kg, AUC (0-12h) was extrapolated based on the pre-dose to 9 hours post-dose PK samples.)|Day 14|Safety population: All enrolled subjects having received the treatment at least once.|||pg*h/mL||Standard Deviation|Mean
2639230|NCT01766440|Primary|AUC (0-9h) of Calcitriol Plasma Level|AUC (0-9h) of calcitriol plasma level at Day 14 (Pre-dose to 9 hours post-dose. For subjects with a body weight of <15 kg, AUC (0-9h) was extrapolated based on the pre-dose to 6 hours post-dose PK samples.)|Day 14|Safety population: All enrolled subjects having received the treatment at least once.|||pg*h/mL||Standard Deviation|Mean
2639231|NCT01766440|Primary|AUC (0-6h) of Calcitriol Plasma Level|AUC (0-6h) of calcitriol plasma level at Day 14 (Pre-dose to 6 hours post-dose)|Day 14|Safety population: All enrolled subjects having received the treatment at least once.|||pg*h/mL||Standard Deviation|Mean
2639232|NCT01766440|Primary|Tmax of Calcitriol Plasma Level|Tmax of calcitriol plasma level at Day 14|Day 14|Safety population: All enrolled subjects having received the treatment at least once.|||hour||Standard Deviation|Mean
2639233|NCT01766440|Primary|Cmin of Calcitriol Plasma Level|Cmin of calcitriol plasma level at Day 14|Day 14|Safety population: All enrolled subjects having received the treatment at least once.|||pg/mL||Standard Deviation|Mean
2639234|NCT01766440|Primary|Cmax of Calcitriol Plasma Level|Cmax of calcitriol plasma level at Day 14 (Peak plasma concentration of calcitriol from Day 1 to Day 14)|Day 14|Safety population: All enrolled subjects having received the treatment at least once.|||pg/mL||Standard Deviation|Mean
2639235|NCT01766401|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe).|Baseline to Week 8|The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of the HAM-A.|||Score on Scale||Standard Deviation|Mean
2639242|NCT01766219|Secondary|Number of Participants With Adverse Events Using the National Cancer Institute Common Terminology Criteria|Adverse events will be captured using the National Cancer Institute Common Terminology Criteria (NCI CTCAE) version 3.0|Up to 1 month completion of study treatment, assessed up to 1 year||||Participants|||Count of Participants
2639243|NCT01766219|Secondary|Progression-free Survival|Estimated using Kaplan-Meier techniques as well as RECIST 1.1. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note:the appearance of one or more new lesions is also considered progression).|From the first dose of 6,8-bis(benzylthio)octanoic acid to disease progression (DP) or death due to any cause, assessed up to 4 years||||months||95% Confidence Interval|Median
2639244|NCT01766219|Secondary|Response Rate Defined as Proportion of Patients With Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)|Using the RECIST version 1.1 as defined by patient with 95% confidence interval will be included. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note:the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study|From the start of the treatment until disease progression, assessed up to 4 year||||participants|||Number
2639245|NCT01766219|Primary|Overall Survival|Estimated using Kaplan-Meier techniques.|From the first dose of 6,8-bis(benzylthio)octanoic acid to death, assessed up to 4 years||||months||95% Confidence Interval|Median
2639246|NCT01766206|Primary|Number of Subjects Reporting Serious AEs (SAEs)|An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening (i.e., the subject was, in the opinion of the investigator, at immediate risk of death from the event as it occurred); it does not refer to an event which hypothetically might have caused death if it were more severe, requires or prolongs subject's hospitalization, results in persistent or significant disability/incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions), results in a congenital anomaly/birth defect, is an important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.|From Day 1 of vaccination to study termination (Day 29/early termination)|This analysis was performed on the Safety per protocol set, which included all enrolled subjects who signed an informed consent, underwent screening, received a subject number, received a study vaccination and provided post vaccination data. Excluding 19 subjects from safety set with protocol violations.|||Participants|||Count of Participants
2639247|NCT01766206|Primary|Number of Subjects Reporting Medically Attended AEs (MAAEs)|MAAEs are defined as events that require a physician's visit or an emergency room visit. All reported MAAEs from day 1 to day 29 were assessed. Subjects from 2 months to 55 years of age were evaluated for the outcome measure.|From Day 1 of vaccination to study termination (Day 29/early termination)|This analysis was performed on the Safety per protocol set, which included all enrolled subjects who signed an informed consent, underwent screening, received a subject number, received a study vaccination and provided post vaccination data. Excluding 19 subjects from safety set with protocol violations.|||Participants|||Count of Participants
2639248|NCT01766206|Primary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|"An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. All unsolicited AEs reported from day 1 to day 7 post vaccination were assessed. Any is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure."|From Day 1 of vaccination to Day 7 post vaccination|This analysis was performed on the Safety per protocol set, which included all enrolled subjects who signed an informed consent,underwent screening, received a subject number, received a study vaccination and provided post vaccination data. Excluding 19 subjects from safety set with protocol violations.|||Participants|||Count of Participants
2639249|NCT01766206|Primary|Number of Subjects Reporting Any Local and Systemic Solicited Adverse Events (AEs)|"Assessed solicited local AEs include: injection site erythema, injection site induration, injection site tenderness, injection site pain. Assessed solicited systemic AEs include: change in eating habits, sleepiness, irritability, rash, vomiting, diarrhea, fever, chills, nausea, malaise, generalized myalgia, generalized arthralgia, headache. Any is defined as any report of the specified symptom irrespective of intensity grade. Subjects from 2 months to 55 years of age were evaluated for the outcome measure."|From Day 1 of vaccination to Day 7 post vaccination|This analysis was performed on the Safety per protocol set, which included enrolled subjects aged from 2 months to 55 years, who signed an informed consent, underwent screening, received a subject number and received a study vaccination and provided post vaccination data. Excluding 19 subjects from safety set with protocol violations.|||Participants|||Count of Participants
2639250|NCT01766102|Secondary|Assessment of Radiographic and Pathologic Findings|"Assessment of radiographic findings and pathologic findings to determine sensitivity, specificity, positive predictive value, and negative predictive values of intra-operative digital specimen mammography (ISM) and standard specimen mammography for determining margin status.~A true positive (TP) was defined as a positive margin by imaging (ISM or SSM) and pathology~A false positive (FP) was defined as a positive margin by imaging but negative by pathology~A true negative (TN) was defined as a negative margin by both imaging and pathology.~A false negative (FN) was defined as a negative margin by imaging but positive by pathology~The sensitivity [TP/(TP + FN)], specificity [TN/(TN + FP)], positive predictive value [TP/ (TP + FP)], and negative predictive value [TN/(TN + FN)] for identification of positive margins were calculated for ISM and SSM."|2 years|Interpretation of margin status by the surgeon was available for 22 of 36 ISM patients. Interpretation of margin status was also available for 22 of 36 SSM patients.|||Percent|||Number
2639596|NCT01763905|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full anlaysis set|||percent change||Standard Error|Least Squares Mean
2639253|NCT01766050|Secondary|Mean Change From Baseline in Heart Rate at Study Discharge (Day 46±2 Days)|Heart Rate was taken after the participant had been sitting quietly for at least 5 minutes and was measured in beats per minute (bpm). Hear rate was taken on Day 46 (day of discharge) during the follow up period. Baseline was defined as last non-missing result with a collection date-time less than the date-time of the first active dose of study drug.|Baseline and Day 46 ±2 days|All participants who received study drug during the treatment period and had measurements at baseline and discharge.|||bpm||Standard Deviation|Mean
2639254|NCT01766050|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure at Study Discharge (Day 46±2 Days)|Systolic and Diastolic blood pressures were taken after the participant had been sitting quietly for at least 5 minutes and the pressures were measured in millimeters of mercury (mm Hg). Systolic and Diastolic blood pressures were taken on Day 46 (day of discharge from the study). Baseline was defined as last non-missing result with a collection date-time less than the date-time of the first active dose of study drug.|Baseline and Day 46 ±2 days|All participants who had received study drug during the treatment period and had measurements at baseline and at discharge.|||mm Hg||Standard Deviation|Mean
2639255|NCT01766050|Secondary|Mean Change From Baseline in Sitting Heart Rate - All Treated Participants|Heart Rate was taken after the participant had been sitting quietly for at least 5 minutes and the heart rate was measured in beats per minute (bpm). Heart Rates were obtained at screening visit, Day -1, and at 0 hour (pre-dose), 0.5 hour (post dose), and 2 hours (post dose) on Days 1, 4, 7, 11. Baseline was defined as last non-missing result with a collection date-time less than the date-time of the first active dose of study drug.|Baseline and 0.5 and 2.0 hours Post Dose on Days 1, 4, 7, and 11|All participants who received study medication and had baseline and specific day measurement.|||bpm||Standard Deviation|Mean
2639256|NCT01766050|Secondary|Mean Change From Baseline in Sitting Systolic and Diastolic Blood Pressure - All Treated Participants|Systolic and Diastolic blood pressures were taken after the participant had been sitting quietly for at least 5 minutes and the pressures were measured in millimeters of mercury (mm Hg). Pressures were obtained at screening visit, Day -1, and at 0 hour (pre-dose), 0.5 hour (post dose), and 2 hours (post dose) on Days 1, 4, 7, 11. Baseline was defined as last non-missing result with a collection date-time less than the date-time of the first active dose of study drug.|Baseline and 0.5 and 2.0 hours Post Dose on Days 1, 4, 7, and 11|All participants who received any study medication and had a baseline and specific day blood pressure measurement available.|||mm Hg||Standard Deviation|Mean
2639257|NCT01766050|Secondary|Number of Participants With Out-of-Range Electrocardiogram Intervals - All Treated Participants|Participants had 12-Lead electrocardiograms (ECGs) performed at Screening Visit, Day 1 prior to dosing, Day 46 ±2, and at early termination. Definition of out-of-range: PR Interval >210 milliseconds (msec); QRS > 120 msec, QT > 500 msec or > 30 msec change from baseline (Day 1); QT with Fridericia correction (QTcF) > 450 msec or change from baseline of > 30 msec to <= 60 msec or change from baseline > 60 msec.|Day 1 to Day 46 ±2 days or at early termination|All participants who received any study medication and had an ECG performed on Day 1, Day 46 or early termination.|||participants|||Number
2639258|NCT01766050|Secondary|Number of Participants With Marked Hematology and Urinalysis Laboratory Abnormalities - All Treated Participants|Samples for laboratory tests were obtained at Screening visit, Day -1 or prior to dosing on Day 1, Days 3, 6, 10, 46 ±2, and at early termination, after 10 hours fasting. Leukocytes: *10^9 cells per liter (c/L) < 0.85*Pre-Rx if Pre-Rx < LLN or <0.9*LLN if LLN <= Pre-Rx or Pre-Rx is missing. Neutrophils (absolute): *10^12 c/L < 0.85* Pre-Rx if Pre-Rx < 1.5, <1.5 if Pre-Rx >= 1.5, < 1.5 if Pre-Rx missing. Urine blood from dipstick: >=2 if Pre-Rx <1 or was missing or if Pre-Rx >=1. Urinary microscopic white blood cells (WBC) and red blood cells (RBC) >= 2 if Pre-Rx <2 or if Pre-Rx was missing or >=4 if Pre-Rx >=2.|Day -1 to Day 46 ±2 days or at early termination|Participants who received any study medication and had laboratory test results.|||participants|||Number
2639259|NCT01766050|Secondary|Number of Participants With Marked Serum Chemistry Laboratory Abnormalities - All Treated Participants|Samples for laboratory tests were obtained at Screening visit, Day -1 or prior to dosing on Day 1, Days 3, 6, 10, 46, and at early termination, after 10 hours fasting. Upper limits of normal (ULN); Lower limits of normal (LLN); Pre-therapy (Rx); micromoles per liter (µmol/L); millimoles per liter (mmol/L); grams per liter (g/L); Units per liter (U/L); Aspartate Aminotransferase (AST); Blood Urea Nitrogen (BUN) Total Bilirubin: >1.1*ULN if Pre-Rx<= ULN or Pre-Rx is missing, or >1.2*Pre-Rx if Pre-Rx >ULN. AST: >1.25*Pre-Rx if Pre-Rx >ULN or 1.25*ULN if Pre-Rx <= ULN or Pre-Rx is missing. BUN: >1.1*ULN if Pre-Rx<= ULN or Pre-Rx is missing, or >1.2*Pre-Rx if Pre-Rx >ULN. Phosphorus: <0.85*LLN if Pre-RX >= LLN or is missing or if Pre-Rx < LLN. total Protein: <0.9*LLN if Pre-Rx>= LLN or is missing or Pre-Rx > LLN. Creatine Kinase: >1.5*Pre-Rx if Pre-Rx > ULN or is missing or Pre-Rx is <= ULN. Lactate Dehydrogenase: >1.25*ULN if Pre-Rx <= ULN or missing, >1.5*Pre-Rx if Pre-Rx > ULN.|Day -1 to Day 46 ±2 days or at early termination|Participants who received any study medication and had laboratory test results.|||participants|||Number
2639260|NCT01766050|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, and AEs Leading to Discontinuation - All Treated Participants|Adverse events were coded according to the Medical Dictionary for Regulatory Activities (MedDRA), version 15.1. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Events captured from Day 1 (pre-dose) to last day prior to discharge (Day 46 ±2). In the total group, a participant with an AE is only counted once (ie, data reflected in Days 1, 4, 7, and 11 below could be the same participant with an AE on multiple days of the study).|Day 1 to Day of discharge (Day 46±2)|All participants who received any study medication.|||participants|||Number
2639312|NCT01766024|Secondary|Кel of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.|Secondary outcome measure for pharmacokinetics analysis|0 to 48 hours post-dose|||||||
2639313|NCT01766024|Secondary|Т½ of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.|Secondary outcome measure for pharmacokinetics analysis|0 to 48 hours post-dose|||||||
2639261|NCT01766050|Secondary|Ratio of 1'-Hydroxy-Midazolam (Cmax) to Midazolam (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (1'-hydroxy-midazolam) to parent (midazolam) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
2639262|NCT01766050|Primary|Adjusted Geometric Mean AUC (0-T) and AUC (INF) of Caffeine With and Without the Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection. AUC (0-T) and AUC (INF) were measured as ng*h/mL.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng*h/mL||90% Confidence Interval|Geometric Mean
2639263|NCT01766050|Primary|Adjusted Geometric Mean Cmax of Caffeine With and Without the Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection. Cmax was measured in ng/mL.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng/mL||90% Confidence Interval|Geometric Mean
2639264|NCT01766050|Primary|Adjusted Geometric Mean AUC (0-T) and AUC (INF) of Dextromethorphan With and Without the Coadministration of Belatacept - PK Evaluable Population|AUC(0-T): area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration and AUC (INF): AUC extrapolated to infinity, were measured as ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for dextromethorphan with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. The poor metabolizer of CYP2D6 was excluded from the statistical analysis. Inje cocktail components (dextromethorphan) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng*h/mL||90% Confidence Interval|Geometric Mean
2639265|NCT01766050|Primary|Adjusted Geometric Mean Cmax of Dextromethorphan With and Without the Coadministration of Belatacept - PK Evaluable Population|Cmax was measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for dextromethorphan with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. The poor metabolizer of CYP2D6 was excluded from the statistical analysis. Inje cocktail components (dextromethorphan) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng/mL||90% Confidence Interval|Geometric Mean
2639266|NCT01766050|Primary|Adjusted Geometric Mean AUC (0-T) and AUC (INF) of Omeprazole With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|AUC(0-T): Area under the plasma concentration-time curve from time zero zero to the time of the last quantifiable concentration and AUC (INF): AUC extrapolated to infinity were measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for omeprazole with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Inje cocktail components (omeprazole) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng*h/mL||90% Confidence Interval|Geometric Mean
2639287|NCT01766050|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of the Inje Cocktail Components (Midazolam, Losartan, Omeprazole, Dextromethorphan, and Caffeine) With and Without Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of dextromethorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection. Tmax was measured in hours (h).|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11||||h||Full Range|Median
2639267|NCT01766050|Primary|Adjusted Geometric Mean Cmax of Omeprazole With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|Cmax: Maximum observed plasma concentration was measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for omeprazole with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Inje cocktail components (omeprazole) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng/mL||90% Confidence Interval|Geometric Mean
2639268|NCT01766050|Primary|Adjusted Geometric Mean AUC (0-T) and AUC (INF) of Losartan With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|AUC (0-T): area under the concentration curve from time 0 to the time of the last quantifiable concentration and AUC (INF) extrapolated to infinity were measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for losartan with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Inje cocktail components (losartan) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng*h/mL||90% Confidence Interval|Geometric Mean
2639269|NCT01766050|Primary|Adjusted Geometric Mean Cmax of Losartan With and Without the Coadministration of Belatacept - PK Evaluable Population|Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for losartan with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Inje cocktail components (losartan) measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng/mL||90% Confidence Interval|Geometric Mean
2639270|NCT01766050|Primary|Adjusted Geometric Mean Area Under the Concentration Time Curve (AUC) From Zero to Last Concentration (0-T) and AUC Extrapolated to Infinity (INF) of Midazolam With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|AUC(0-T): area under the plasma concentration-time curve from zero to the last time of the last quantifiable concentration and AUC (INF): AUC from time zero extrapolated to infinite time were measured in ng*h/mL. Samples for the assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for midazolam with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Midazolam measured using HPLC with MS/MS Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng*h/mL||90% Confidence Interval|Geometric Mean
2639271|NCT01766050|Secondary|Ratio of 1'-Hydroxy-Midazolam AUC(0-T) to Midazolam AUC(0-T) and 1'-Hydroxy-Midazolam AUC(INF) to Midazolam AUC(INF), Corrected for Molecular Weight [MR_AUC(0-T), MR_AUC (INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (1'-hydroxy-midazolam) to parent (midazolam) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
2639272|NCT01766050|Secondary|Ratio of 5-Dextrorphan (Cmax) to Dextromethorphan (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (5-dextrorphan) to parent (dextromethorphan) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
2639308|NCT01766024|Secondary|Adverse Event (AE) and Serious Adverse Event (SAE) Incidence|Secondary outcome measure for safety assessment|up to Day 43|||||||
2639309|NCT01766024|Secondary|Tmax of Neopterin and MxA Protein|Secondary outcome measure for pharmacodynamics analysis|0 to 168 hours post-dose|||||||
2639273|NCT01766050|Secondary|Ratio of 5-Dextrorphan AUC(0-T) to Dextromethorphan AUC(0-T) and 5-Dextrorphan AUC(INF) to Dextromethorphan AUC(INF), Corrected for Molecular Weight [MR_AUC(0-T), MR_AUC (INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (5-dextrorphan ) to parent (dextromethorphan) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
2639274|NCT01766050|Secondary|Ratio of 5-Hydroxyomeprazole (Cmax) to Omeprazole (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (5-hydroxyomeprazole) to parent (omeprazole) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
2639275|NCT01766050|Secondary|Ratio of 5-Hydroxyomeprazole AUC(0-T) to Omeprazole AUC(0-T) and 5-Hydroxyomeprazole AUC(INF) to Omeprazole AUC(INF) , Corrected for Molecular Weight [MR_AUC(0-T), MR_AUC(INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (5-Hydroxyomeprazole) to parent (omeprazole) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
2639276|NCT01766050|Secondary|Ratio of E-3174 (Cmax) to Losartan (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (E-3174) to parent (losartan) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
2639277|NCT01766050|Secondary|Ratio of E-3174 AUC(0-T) to Losartan AUC(0-T) and E3174 AUC (INF) to Losartan AUC (INF) Corrected for Molecular Weight [MR_AUC(0-T), MR_AUC(INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (E-3174) to parent (losartan) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
2639278|NCT01766050|Secondary|Ratio of Paraxanthine (Cmax) to Caffeine (Cmax), Corrected for Molecular Weight (MR_Cmax) With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (paraxanthine) to parent (caffeine) ratio was corrected for molecular weight. Cmax measured in ng/mL. Samples for assessment of plasma concentrations of Inje cocktail components and their metabolites were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
2639279|NCT01766050|Secondary|Ratio of Paraxanthine AUC(0-T) to Caffeine AUC(0-T) and Paraxanthine AUC (INF) to Caffeine AUC (INF), Corrected for Molecular Weight [MR_AUC(0-T) and MR_AUC (INF)] With and Without Coadministration of Belatacept - PK Evaluable Population|Metabolite (paraxanthine) to parent (caffeine) ratio was corrected for molecular weight. AUC (0-T) and AUC (INF) measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components and the metabolites of those components were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ratio||Geometric Coefficient of Variation|Geometric Mean
2639310|NCT01766024|Secondary|Cmax of Neopterin and MxA Protein Blood Samples Were Taken Before the Injection, Then After 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 Hours.|Secondary outcome measure for pharmacodynamics analysis|0 to 168 hours post-dose|||||||
2639280|NCT01766050|Secondary|T-HALF of Inje Cocktail Component Metabolites (1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without the Coadministration of Belatacept - PK Evaluable Population|Plasma half-life (T-HALF) was measured in hours (h). Samples for assessment of plasma concentrations of Inje cocktail components metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||h||Standard Deviation|Mean
2639281|NCT01766050|Secondary|Tmax of Inje Cocktail Component Metabolites (1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without the Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection. Time of maximum observed plasma concentration (Tmax) was measured in hours (h).|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||h||Full Range|Median
2639282|NCT01766050|Secondary|AUC(INF) of Inje Cocktail Component Metabolites (1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without Coadministration of Belatacept - PK Evaluable Population|Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] was measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2639283|NCT01766050|Secondary|AUC(0-T) of Inje Cocktail Component Metabolites (1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without Coadministration of Belatacept - PK Evaluable Population|Area under the plasma concentration-time curve from zero to the last time of the last quantifiable concentration [AUC(0-T)] was measured in ng*h/mL. Samples for assessment of plasma concentrations of Inje cocktail components metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2639284|NCT01766050|Secondary|Cmax of Inje Cocktail Metabolites (1'-Hydroxy-Midazolam, E-3174, 5-Hydroxyomeprazole, Dextrorphan, and Paraxanthine) With and Without Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail component metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of Dextrorphan parameters. Inje cocktail component metabolites were each measured using HPLC with MS/MS detection. Cmax was measured in ng/mL.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2639285|NCT01766050|Secondary|Apparent Total Body Clearance (CLT/F) of the Inje Cocktail Components (Midazolam, Losartan, Omeprazole, Dextromethorphan and Caffeine) With and Without Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of dextromethorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection. CLT/F was measured as liters/hour (L/h)|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11||||L/h||Geometric Coefficient of Variation|Geometric Mean
2639286|NCT01766050|Secondary|Plasma Half-Life (T-HALF) of the Inje Cocktail Components (Midazolam, Losartan, Omeprazole, Dextromethorphan, and Caffeine) With and Without Coadministration of Belatacept - PK Evaluable Population|Samples for assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. The poor metabolizer of CYP2D6 was excluded from summary of dextromethorphan parameters. Inje cocktail components were each measured using HPLC with MS/MS detection. T-HALF was measured in hours (h).|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Evaluable PK population: Participants who received any study drug and had at least 1 adequate PK profile for any Inje cocktail analytes (parent or metabolite).|||h||Standard Deviation|Mean
2639311|NCT01766024|Secondary|Cl of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.|Secondary outcome measure for pharmacokinetics analysis|0 to 48 hours post-dose|||||||
2639288|NCT01766050|Primary|Adjusted Geometric Mean Maximum Drug Concentration (Cmax) of Midazolam With and Without the Coadministration of Belatacept - Pharmacokinetic (PK) Evaluable Population|Samples for the assessment of plasma concentrations of Inje cocktail components (midazolam, losartan, omeprazole, dextromethorphan and caffeine) and their metabolites (1'-hydroxy-midazolam, E-3174, 5-hydroxyomeprazole, dextrorphan, and paraxanthine) were collected at time = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, and 24 hours relative to the dosing of belatacept on Day 4 and Inje cocktail dosing on Days 1, 4, 7, and 11, respectively. Adjusted geometric mean for midazolam with and without belatacept, along with adjusted geometric mean ratios for Days 4, 7, and 11 versus Day 1, respectively, are presented. Cmax measured in nanograms per milliliter (ng/mL). Inje cocktail components (Midazolam) measured using High Performance Liquid Chromatography (HPLC) with Tandem Mass Spectrometry (MS/MS) Detection.|Pre-dose to 24 hours after dose of the Inje Cocktail on Days 1, 4, 7 and 11|Participants who received any study drug and had at least 1 adequate Pharmacokinetic (PK) profile for any Inje cocktail analytes (parent or metabolite).|||ng/mL||90% Confidence Interval|Geometric Mean
2639289|NCT01766037|Other Pre-specified|Safety Outcomes|The incidence of procedure-related, device-related, and therapy-related serious adverse events. Also, the development of adverse eating behaviors will be assessed.|52 weeks|Modified Intent To Treat (mITT) population of all enrolled subjects|||Percent of Subjects|||Number
2639290|NCT01766037|Secondary|Change in Number of Subjects on Diabetes Medication|Percent change in the number of subjects on Diabetes medication|52 weeks|Subjects being treated for Type II Diabetes|||% Change in Subjects on Medication|||Number
2639291|NCT01766037|Secondary|Change in Number of Subjects on Dyslipidemia Medications|Percent change in the number of subjects on Dyslipidemia medications|52 weeks|Subjects being treated for high cholesterol|||% Change in Subjects on Medication|||Number
2639292|NCT01766037|Secondary|Change in Number of Subjects on Hypertension Medication|Percent change in the number of subjects on Hypertension medication|52 weeks|Subjects being treated for hypertension|||% Change in Subjects on Medication|||Number
2639293|NCT01766037|Secondary|Change in Medications for Type 2 Diabetes|Percent change in the number of medications taken by subjects for Type 2 Diabetes|52 weeks|Subjects being treated for Type 2 Diabetes|||Percent Change in Medications|||Number
2639294|NCT01766037|Secondary|Change in Medications for Dyslipidemia|Percent change in the number of medications taken by subjects for dyslipidemia|52 weeks|Subjects being treated for high cholesterol|||Percent Change in Medications|||Number
2639295|NCT01766037|Secondary|Change in Medication for Hypertension|Percent change in the number of medications taken by subjects for hypertension|52 weeks|Subjects being treated with medications for hypertension|||Percent Change in Medications|||Number
2639296|NCT01766037|Secondary|Procedural Success|vii) percent procedural success (defined as successful endoscopic placement of the A-Tube) in all subjects undergoing endoscopy|52 weeks|All A-Tube placement attempts|||Percent Procedural Success|||Number
2639297|NCT01766037|Secondary|Mean Change in Hemoglobin A1C|vi) change in mean hemoglobin A1C (only subjects with T2 diabetes at baseline). Hemoglobin A1C is measured as DCCT%. The change in mean DCCT% from Baseline to Week 52 is reported for this secondary endpoint.|52 weeks|Subjects with Type 2 Diabetes|||DCCT% change||95% Confidence Interval|Mean
2639298|NCT01766037|Secondary|Mean Change in Score for IWQOL Questionnaire|"v) Impact of Weight on Quality of Life (IWQOL) questionnaire total score~Total score ranges from a minimum of 0 to a maximum of 100. Based on the algorithm developed by Crosby, et.al., patients' IWQOLLite total scores are considered to have shown meaningful improvement from baseline to one year if they increased between 7 and 12 points, depending upon baseline severity in comparison to the normative mean. Normative means for the IWQOL-Lite have been derived from a sample of 534 non-obese individuals who were not enrolled in any weight loss treatment program [238 women and 296 men with BMI's between 18.5 and 29.9]. The data presented is the mean change in total score. The AT group demonstrated a mean improvement (increase) in score of 16.3 points, the Control group a mean improvement (increase) of 11.7 points."|52 weeks|Subjects who completed the Questionnaire at 52 weeks|||score on a scale||95% Confidence Interval|Mean
2639299|NCT01766037|Secondary|Mean Percent Change in Blood Pressure|iv) mean percent change in systolic and diastolic blood pressures in the AT group compared to the control group|52 weeks|Subjects who completed 52 weeks|||Percent Change||95% Confidence Interval|Mean
2639300|NCT01766037|Secondary|Mean Percent Change in Serum Lipids|iii) mean percent change serum lipids (triglyceride, HDL-cholesterol and LDL-cholesterol concentration) in the AT group compared to the control group|52 weeks|Subjects who completed 52 weeks|||Percent Change||95% Confidence Interval|Mean
2639301|NCT01766037|Secondary|Percent of Subjects With ≥10% Total Body Weight Loss|ii) proportion of subjects who achieve ≥10% absolute weight loss in AT compared to Control group|52 weeks|Modified Intent To Treat (mITT) population of all enrolled subjects|||Percent of Subjects||95% Confidence Interval|Number
2639302|NCT01766037|Secondary|Mean Percent Total Body Weight Loss|i) Mean percent absolute weight loss in AT compared to Control group|52 weeks|Modified Intent To Treat (mITT) population of all enrolled subjects|||Percent Total Weight Loss||Standard Deviation|Mean
2639303|NCT01766037|Primary|% of Subjects Who Achieve >25% EWL|The second co-primary effectiveness endpoint is that at least 50% of the AT group at 52-weeks achieve > 25% EWL.|52 weeks|Modified Intent To Treat (mITT) population of all enrolled subjects|||Percent of Subjects||95% Confidence Interval|Number
2639304|NCT01766037|Primary|Mean Percent Excess Weight Loss (%EWL)|The first effectiveness co-primary endpoint is the mean percent excess weight loss (%EWL) at 52-weeks. The hypothesis for the first primary effectiveness endpoint is that the difference in the mean percent excess weight loss (%EWL) at 52-weeks for the Aspiration Therapy (AT) group and Control group is at least 10%. Percent EWL is defined as absolute weight loss divided by baseline excess weight and multiplied by 100. Excess weight is determined from ideal body weights based on a BMI=25 kg/m2.|52 weeks|Modified Intent To Treat (mITT) population defined as all enrolled subjects|||Percent Excess Weight Loss||Standard Deviation|Mean
2639305|NCT01766024|Secondary|Study Withdrawal Rate Due to AE|Secondary outcome measure for safety assessment|up to Day 43|||||||
2639306|NCT01766024|Secondary|Local Reaction Incidence|Secondary outcome measure for tolerability assessment|up to Day 43|||||||
2639307|NCT01766024|Secondary|AE of Garde 3-4 Incidence|Secondary outcome measure for safety assessment|up to Day 43|||||||
2639314|NCT01766024|Secondary|Тmax of Interferon Beta-1a Blood Samples Were Taken Before the Injection, Then After 15 Min, 30 Min, 45 Min, 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours and 48 Hours.|Secondary outcome measure for pharmacokinetics analysis|0 to 48 hours post-dose|||||||
2639315|NCT01766024|Primary|AUC(0-168) and AUC(0-∞) of Neopterin and MxA Protein|Primary outcome measure for pharmacodynamics analysis. Blood samples were taken before the injection, then after 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours.|0 to 168 hours post-dose||||(ng/ml)*h||Inter-Quartile Range|Median
2639316|NCT01766024|Primary|Cmax of Interferon Beta-1a|Primary outcome measure for pharmacokinetics analysis Blood samples were taken before the injection, then after 15 min, 30 min, 45 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours and 48 hours.|0 to 48 hours post-dose||||pg/ml||Inter-Quartile Range|Median
2639317|NCT01766024|Primary|Area Under Concentration-time Curve (AUC) of Interferon (IFN) Beta-1a From the Moment of Drug Administration Until 48 Hours and to Infinity(AUC(0-48) and AUC(0-∞) Respectively)|Primary outcome measure for pharmacokinetics analysis. Blood samples were taken before the injection, then after 15 min, 30 min, 45 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours and 48 hours.|0 to 48 hours post-dose||||(pg/ml)•h||Inter-Quartile Range|Median
2639318|NCT01765972|Primary|Percentage Change From Baseline of Corneal Swelling 8 Hours Post Fit|Central corneal thickness was measured at baseline and 8-hour post fit with a modified optical pachometer on a Zeiss biomicroscope, interfaced to a PC. The pachometry measurement included seven readings; the computer is programmed to remove the high and low readings and to calculate the average of the remaining five readings. Only a single central corneal thickness measurement, the average of the 5 readings, was recorded by the investigator in the eCRF. The average percent change from baseline of corneal swelling was reported and was calculated as: ((Post fit - Baseline)/ Baseline) X 100.|8 hours post fit|Analysis population consists of subjects that completed all study visits without a major protocol deviation.|||percentage of change from baseline||Standard Deviation|Mean
2639319|NCT01765803|Secondary|Toxicity|"Toxicity will be evaluated according to the grading system (0-5) NCI CTCAE (Common Terminology Criteria for Adverse Events) version 4.~Any subject who receives treatment on this protocol will be evaluable for toxicity."|Up to 1 month after treatment||||participants|||Number
2639320|NCT01765803|Primary|CD34+ Progenitor Cell Mobilization|To measure CD34+ cells, a peripheral blood draw is taken from the enrolled subject at hour zero on day one of the study before treatment with oral thioridazine. Following treatment, blood draws are taken at 2, 4, 8 and 24 hours. These blood samples are analyzed using Clinical Laboratory Improvement Amendments (CLIA)-approved flow cytometry for CD34+ cell content. CD34+ cell levels will be reported as a percentage of total white blood cells (WBC) in the blood specimens and the difference between baseline and 8 hours will be reported|8 hours following treatment||||percentage of total WBC count||Standard Deviation|Mean
2639321|NCT01765764|Secondary|Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6|"ESS Item #6 measured the participant's satisfaction with eyebrow treatment: Overall, how satisfied are you with the way the eyebrow treatment makes your eyebrows look right now? using a 5-point scale where: 1=very satisfied, 2=mostly satisfied, 3=neither dissatisfied nor satisfied, 4=mostly dissatisfied and 5=very dissatisfied. The percentage of participants 'very satisfied' or 'mostly satisfied' is reported."|Month 7|Intent-to-treat population included all randomized participants.|||percentage of participants|||Number
2639322|NCT01765764|Secondary|Change From Baseline in Eyebrow Darkness as Measured Using DMSIA|Photographs were taken of the eyebrows. Eyebrow darkness (intensity) was measured by DMSIA for both eyes and averaged. Eyebrow darkness was reported in intensity units. A negative change from Baseline indicated darker eyebrows (improvement).|Baseline, Month 7|Participants from the Intent-to-treat population, all randomized participants, with data available for analysis.|||intensity units||Standard Deviation|Mean
2639323|NCT01765764|Secondary|Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA)|Photographs were taken of the eyebrows. Eyebrow fullness was measured by DMSIA for both eyes and averaged. Eyebrow fullness was reported in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyebrows (improvement).|Baseline, Month 7|Participants from the Intent-to-treat population, all randomized participants, with data available for analysis.|||mm^2||Standard Deviation|Mean
2639324|NCT01765764|Primary|Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale|The physician evaluated eyebrow fullness using the 4-point GEBA Scale where: 1=very sparse, 2=sparse, 3=full and 4=very full. The percentage of participants with at least a 1-grade increase from Baseline is reported.|Baseline, Month 7|Intent-to-treat population included all randomized participants.|||percentage of participants|||Number
2639325|NCT01765751|Other Pre-specified|Patient Satisfaction Questionnaire|Participants' satisfaction with study procedures and staff were assessed at Study Visit 5 using standard questions. Participants rated their satisfaction with various elements of the study (e.g., treatments received, clinicians) using a 5 category response from 1 (strongly satisfied) to 5 (strongly dissatisfied) with categories collapsed into satisfied (categories 1 and 2) or not satisfied (categories 3, 4 or 5) for interpretation.|Day 14 (Study Visit 5)||||Participants|||Count of Participants
2639326|NCT01765751|Other Pre-specified|Cervical Muscle Electromyographic (EMG) Activity|"We will describe electromyographic (EMG) activity of superficial neck muscles during delivery of the three manual interventions during visits 3 and 4. EMG measurements are an exploratory outcome variable in this study.~RMS EMG TREATMENT DESCRIPTIONS:~(A) Ratio of Root Mean square (RMS) EMG during Treatment at C5/RMS EMG during maximum voluntary contraction (MVC)~(B) RMS EMG during Treatment at C5/RMS EMG during Prone Resting~(C) RMS EMG during Treatment at Occiput (OCC)/RMS EMG during MVC~(D) RMS EMG during Treatment at OCC/ RMS EMG during Prone Resting~MUSCLES:~LES-Left erector Spinae Muscle~RES-Right Erector Spinae Muscle~LTRPS- Left Trapezius muscle~RTRPS- Right Trapezius Muscle~LSCM- Left Sternocleido Mastoid muscle~RSCM- Right Sternocleido Mastoid Muscle~ACRONYM KEY:~RMS-Root Mean Square Value~MVC-Maximum Voluntary Contraction~C5-Cervical vertebrae contact~OCC-Occipital contact~EMG-Electromyographic activity"|Day 8 (Study Visit 3), Day 11 (Study Visit 4)|The numbers analyzed in the row differ from the overall due to: (1) Data not collected due to technical problems, (2) Patient did not show up for the visit, (3) 3 participants lost to follow up.|||ratio||Standard Deviation|Mean
2639327|NCT01765751|Secondary|Credibility and Expectancy Questionnaire (CEQ)|The CEQ is a quick and easy-to-administer questionnaire for measuring treatment expectancy and rationale credibility of interventions for use in clinical outcome studies. Participants' perceptions of the study treatments were compared across groups using the CEQ. The CEQ credibility factor relates to how logical or believable a treatment is for the patient, whereas the expectancy factor refers to the patient's beliefs about improvements that might be achieved from the treatment [61]. CEQ scores for both the credibility and expectancy factors range from 3 to 27, with higher scores indicating greater belief in treatment credibility or expectancy for clinical improvement.|Baseline, Day 1 (Study Visit 1), Day 14 (Study Visit 5)||||units on a scale (range 3-27)||Standard Deviation|Mean
2639328|NCT01765751|Secondary|Procedure Believability Questionnaire|"We will ask all participants whether they feel the study procedure would relieve their neck pain using the Procedure Believability Questionnaire. The response choices will be: Strongly believe the procedure will relieve my neck pain; Somewhat believe the procedure will relieve my neck pain; Somewhat believe the procedure will NOT relieve my neck pain; Strongly believe the procedure will NOT relieve my neck pain; and Don't know if the procedure will relieve my neck pain. A baseline (BL) evaluation will be completed based upon treatment description, and compared to assessments following study visit 1 (T1) and study visit 5 (T5) over a 2-week time period."|Baseline (BL), Day 1 (Study Visit 1/T1), Day 14 (Study Visit 5/T5)||||Participants|||Count of Participants
2639329|NCT01765751|Secondary|Cervical Range of Motion (cROM).|"Cervical ranges of motion are a measure of functional status and can be used to assess dysfunction in the cervical spine. Baseline/visit 1 (BL) cROM is displayed for Flexion-Extension, Lateral Bending, and Rotation. The mean change in cROM from visit 1 to visit 5 (V5 change) is also displayed."|Change from Day 1 (Study Visit 1) to Day 14 (Study Visit 5)|"The number analyzed in row differs from overall due to:~Data collection issue due to equipment problems.~Participants did not show up for data collection.~3 Participants were lost to follow up"|||Degrees - Range of Motion||Standard Deviation|Mean
2639330|NCT01765751|Secondary|Patient Reported Outcomes Measurement Information System (PROMIS-43)|"The PROMIS-43 questionnaire will be used to measure general functional health status. PROMIS-43 questions measure physical function, anxiety, depression, fatigue, sleep disturbance, social role satisfaction, and pain interference and intensity.~The table below displays the mean score at baseline. On the T-score metric & interpretation:~A score of 40 is one SD lower than the mean of the reference population (REF POP).~A score of 60 is one SD higher than the mean of the REF POP.~For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one SD above the average REF POP. This could be a desirable or undesirable outcome, depending upon the concept being measured. For Physical Function and Satisfaction with Social Role, higher scores reflect a better outcome, while for the remaining concepts, higher scores reflect a worse outcome.~PROMIS - Pain Interference adjusted for baseline neck pain VAS."|Change from Baseline to Day 14 (Study Visit 5)||||T-score||Standard Deviation|Mean
2639331|NCT01765751|Secondary|Neck Pain Visual Analogue Scale (VAS)|The VAS has excellent metric properties, is easy to administer and score (0-100mm), and is commonly used in pain research. Our anchors will be no pain (score of 0) to worst pain imaginable (score of 100). We will ask participants to rate their current neck pain at baseline and pre-/post-treatment for all 5 study visits. This measure is adjusted mean neck pain VAS change. A single value was calculated by averaging.|Change from Baseline, Day 1, 4, 8, 11, 14 (Pre- and Post-Study Visits 1, 2, 3, 4, 5)||||mm||95% Confidence Interval|Mean
2639332|NCT01765751|Secondary|Neck Disability Index (NDI)|The NDI is a 10-item questionnaire modified from the Oswestry Low Back Pain Disability Index. The NDI has been shown to be a reliable and valid measure of disability due to neck pain, and responsive for measuring change. Study Visit 1 and Study Visit 5 Measures occur 2 weeks apart. The NDI scale is measured on a scale of 0-50, with 0 indicating no disability and 50 indicating complete disability. This measure is an adjusted mean NDI change.|Change from Baseline to Day 1 (Study Visit 1) and Day 14 (Study Visit 5)||||units on scale||95% Confidence Interval|Mean
2639333|NCT01765751|Primary|Range of Traction Forces|We will evaluate the clinician's ability to deliver three randomly assigned manual interventions to the cervical spine within specified traction force ranges (<20 Newtons [N], 20-50N, >50N). The primary outcome of this study is to determine the accuracy and consistency of traction force delivery ranges both between clinicians and within individual clinicians. Traction force ranges (C5 contact level and Occiput contact level) will be measured at each study visit (visits 1, 2, 3, 4, 5) for 2 weeks and averaged to calculate final outcome.|Day 1, 4, 8, 11, 14 (Each Study Visit)|*Cervical traction forces measured in Newtons (N) over four treatment visits for each participant. We recorded 23 missing values for traction forces due to 9 missing appointments (18 observations) and 5 instances of technical problems in data collection.|||Newtons (N)|Number of Observations*|Standard Deviation|Mean
2639334|NCT01765673|Secondary|Change in Swallow Initiation Time|Change in swallow initiation time (ms) from swallow reaction time during vibrotactile stimulation minus reaction time with sham (no) stimulation|During one session within 1 hour||||millisseconds||Standard Deviation|Mean
2639335|NCT01765673|Secondary|Percent Change in Swallow Frequency Pulse vs Continuous|Percent Change= [(Number of swallows per minute from continuous stimulation -number of swallows per minute during pulsed stimulation) / number of swallows per minute during pulsed stimulation] X 100|During one session within one hour||||percent change||Standard Deviation|Mean
2639336|NCT01765673|Secondary|Change in Swallow Frequency 6 kPa|The pressure between the neck band and the skin was set and the changes in swallowing frequency was compared between increased pressure and no pressure condition|During one session within 1 hour||||Change in swallows/min||Standard Deviation|Mean
2639337|NCT01765673|Secondary|Change in Swallow Frequency 4 kPa|The pressure between the neck band and the skin was set and the changes in swallowing frequency was compared between pressure between increased pressure and no pressure condition|During one session within 1 hour||||Change in swallows/min||Standard Deviation|Mean
2639338|NCT01765673|Secondary|Change in Swallowing Frequency 2 kPa|The pressure between the neck band and the skin was set and the changes in swallowing frequency was compared between pressure between increased pressure and no pressure condition|During one session within 1 hour||||Change in Swallow/min||Standard Deviation|Mean
2639597|NCT01763905|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639339|NCT01765673|Secondary|Change in Discomfort 70 & 110 Hz|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.|During one session within 1 hour||||Change in discomfort||Standard Deviation|Mean
2639340|NCT01765673|Secondary|Change in Discomfort 150 Hz|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.|During one session within 1 hour||||Change in discomfort||Standard Deviation|Mean
2639341|NCT01765673|Secondary|Change in Discomfort 110 Hz|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.|During one session within 1 hour||||Change in discomfort||Standard Deviation|Mean
2639342|NCT01765673|Secondary|Change in Discomfort 70 Hz|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.|During one session within 1 hour||||Change in discomfort||Standard Deviation|Mean
2639343|NCT01765673|Secondary|Change in Discomfort Level 30 Hz|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived discomfort between a minimum of 1 with no discomfort and a maximum of 100 which is the highest discomfort possible. The Change in perceived discomfort when stimulation was presented minus the perceived discomfort following no stimulation was computed.|During one session within 1 hour||||Change in discomfort||Standard Deviation|Mean
2639344|NCT01765673|Secondary|Change in VAS Urge to Swallow 70 & 110 Hz|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.|During one session within 1 hour||||Change in VAS Urge to Swallow||Standard Deviation|Mean
2639345|NCT01765673|Secondary|Change in VAS Urge to Swallow 150 Hz|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.|During one session within 1 hour||||Change in VAS Urge to Swallow||Standard Deviation|Mean
2639346|NCT01765673|Secondary|Change in VAS Urge to Swallow 110 Hz|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.|During one session within 1 hour||||Change in VAS Urge to Swallow||Standard Deviation|Mean
2639347|NCT01765673|Secondary|Change in Urge to Swallow 70 Hz|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.|During one session within 1 hour||||Change in VAS Urge to Swallow||Standard Deviation|Mean
2639348|NCT01765673|Secondary|Change in Urge to Swallow After 30 Hz Stimulation|At the end of each stimulation session participants marked on a visual analogue scale (VAS) their perceived urge to swallow between a minimum of 1 with no urge to swallow and a maximum of 100 which is the highest urge to swallow possible. The Change in perceived urge to swallow when stimulation was presented minus the perceived urge to swallow following no stimulation was computed.|During one session within 1 hour||||Change in VAS Urge to Swallow||Standard Deviation|Mean
2639349|NCT01765673|Primary|Change in Swallowing Frequency 70 & 110 Hz|Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)|During one session within 1 hour||||Change in swallows/min||Standard Deviation|Mean
2639350|NCT01765673|Primary|Change in Swallow Frequency 150 Hz|Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)|During one session within 1 hour||||Change in swallows/min||Standard Deviation|Mean
2639351|NCT01765673|Primary|Change in Swallow Frequency 110 Hz|Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)|During one session within 1 hour||||Change in swallows/min||Standard Deviation|Mean
2639352|NCT01765673|Primary|Change in Swallow Frequency 70 Hz|Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)|During one session within 1 hour||||Change in Swallows/min||Standard Deviation|Mean
2639353|NCT01765673|Primary|Change in Swallow Frequency 30 Hz|Change in number of swallows per minute during stimulation minus swallows per minute during sham (wearing the device but no stimulation)|During one session within 1 hour||||Change in swallows/min||Standard Deviation|Mean
2639354|NCT01765647|Secondary|ATG Antibody Level|The ATG antibody level will be measured at baseline, week 2, week 4 and week 6. Normal values are less than 7; elevated values mean a worse outcome. Assessed at baseline, week 2, week 4 and week 6; baseline and week 6 reported.|screening through final visit||||U/mL||Standard Deviation|Mean
2639367|NCT01765569|Primary|Time to Maximum Plasma Concentration (Tmax) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population.|||hours||Full Range|Median
2639355|NCT01765647|Secondary|Health Related Quality of Life|"health related quality of life will be measured at 4 time points using a validated tool; (short form 36; SF-36) baseline, week 2, week 4, and at the end of the study at week 6.~Scores can range from 20-80, with 50 being a population norm. Therefore, a score above 50 indicates better than the general population norm, and a score below 50 indicates worse than the population norm."|week 6|Scores were assessed at baseline, week 2, week 4 and week 6; baseline and week 6 reported.|||score on a scale||Full Range|Mean
2639356|NCT01765647|Secondary|Number Celiac Disease Related Symptoms in Participants|Symptoms of Celiac disease will be self-measured by participants daily for the entire 6 week study period using the Celiac Symptom Index tool.|daily for 6 weeks||||Number of Celiac Disease Related Symptom|||Number
2639357|NCT01765647|Primary|Number of Participants for Which Treatment Was Concluded to be Safe|Measures include: adverse events, serious adverse events, withdrawal due to adverse events, abnormal lab results|week 6||||participants|||Number
2639358|NCT01765582|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Randomization up to approximately 3 years|Safety population was defined as all randomized participants who received at least one partial or complete dose of study medication.|||Percentage of participants|||Number
2639359|NCT01765582|Secondary|Proportion of Participants Considered by the Investigator to be Unresectable on Study Enrollment Who Subsequently Underwent Attempted Curative Resections of Metastases|The proportion of participants considered by the investigator to be unresectable at study enrollment who subsequently underwent attempted curative resections of metastases was calculated as follows: number of participants considered by the investigator to be unresectable at study enrollment who subsequently underwent attempted curative resections of metastases divided by total number of participants in each arm. This outcome represents a measure of the rate of conversion from unresectable to resectable disease.|Randomization up to approximately 3 years|ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment.|||Proportion of participants||90% Confidence Interval|Number
2639360|NCT01765582|Secondary|Proportion of Participants Who Underwent Liver Metastases Resections|Reported here is the proportion of participants who underwent liver metastases resections calculated as follows: number of participants who underwent liver metastases resections divided by total number of participants in each arm.|Randomization up to approximately 3 years|ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment.|||Proportion of participants||90% Confidence Interval|Number
2639361|NCT01765582|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death from any cause.|Randomization until death due to any cause (up to approximately 3 years)|ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment.|||months||90% Confidence Interval|Median
2639362|NCT01765582|Secondary|Time to PFS2|Time to PFS2 was defined as time from randomization to the first occurrence of disease progression after reinduction of second-line therapy, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first. Disease progression was defined as sum of longest diameters increased by at least 20% from the smallest value on study. The sum of longest diameters must also demonstrate an absolute increase of at least 5mm.|Randomization up to disease progression during second-line therapy or death, whichever occurs first (up to approximately 3 years)|ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment.|||months||90% Confidence Interval|Median
2639363|NCT01765582|Primary|Progression-Free Survival During First-Line Therapy (PFS1)|PFS1 was defined as time from randomization to the first occurrence of disease progression during first-line therapy, as assessed by the Investigator using RECIST v1.1, or death from any cause, whichever occurs first. Disease progression was defined as sum of longest diameters increased by at least 20% from the smallest value on study. The sum of longest diameters must also demonstrate an absolute increase of at least 5 mm.|Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years)|ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment.|||months||90% Confidence Interval|Median
2639364|NCT01765582|Primary|Percentage of Participants With Overall Response During First-Line Therapy (ORR1)|ORR1 was the percentage of participants with complete response (CR) or partial response (PR) during first-line therapy as assessed by investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1). CR was defined as disappearance of all extranodal target lesions and all pathological lymph nodes had to have decreased to <10 millimeter (mm) in short axis. PR was defined as at least a 30% decrease in the sum of longest diameters of target lesions, taking as reference the baseline sum diameters. ORR1 = CR + PR|Randomization up to disease progression during first-line therapy or death, whichever occurs first (up to approximately 3 years)|ITT population was defined as all randomized participants regardless of whether they received any dose of study treatment.|||Percentage of participants|||Number
2639365|NCT01765569|Primary|Apparent Clearance (CL/F) of Digoxin|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population. Number of participants analysed = participants evaluable for the analysis.|||liters/hour||Standard Deviation|Mean
2639366|NCT01765569|Primary|Terminal Half-Life (t1/2) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population. Number of participants analysed = participants evaluable for the analysis.|||hours||Standard Deviation|Mean
2639368|NCT01765569|Primary|Maximum Plasma Concentration (Cmax) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population.|||ng/mL||Standard Deviation|Mean
2639369|NCT01765569|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC168) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population.|||hour*ng/mL||Standard Deviation|Mean
2639370|NCT01765569|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC24) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population.|||hour*ng/mL||Standard Deviation|Mean
2639371|NCT01765569|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Digoxin||Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population. Number of participants analysed = participants evaluable for the analysis.|||hour*ng/mL||Standard Deviation|Mean
2639372|NCT01765569|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of Digoxin|AUClast = Area under the plasma-concentration time curve from time zero to the last measurable plasma concentration which is presented in hour*nanogram per milliliter (hour*ng/mL). Hour 0 (H0) signified pre-dose sampling.|Hour [H] 0, 0.5, 1, 2, 3, 4, 6, 8, 10−12 (Day [D] 1), 24, 30-32 (D2), 48 (D3), 72 (D4), 96 (D5), 168 (D8) post-digoxin dose; H0, 0.5, 1, 2, 3, 4, 6, 8, and 10−12H (D29), 24, 30-32 (D30), 48 (D31), 72 (D32), 96 (D33), 168 (D36) post digoxin dose|PK Population included participants for whom PK data were collected.|||hour*ng/mL||Standard Deviation|Mean
2639373|NCT01765543|Other Pre-specified|Percent Extrapolated AUC(0-inf) (AUCpeo) of Vemurafenib|The AUCpeo, that is, percent area obtained after extrapolation from Tlast to infinity is calculated by using the formula AUCpeo = 100*(AUC[0-inf] minus AUC[0-last])/AUC(0-inf). This parameter provides information about what percentage of the theoretical curve AUC(0-inf) is possible to determine experimentally (AUC0-last).|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population|||percent AUC||Geometric Coefficient of Variation|Geometric Mean
2639374|NCT01765543|Other Pre-specified|Area Under the Plasma Concentration Time-curve From Zero to 168 Hours [AUC(0-168)] of Vemurafenib|AUC(0-168) is the AUC from time zero (pre-dose) to 168 hours (time point for last blood sample collection). AUC is a measure of the plasma concentration of a drug over time. AUC(0-168) is presented in mcg*h/mL.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2639375|NCT01765543|Other Pre-specified|Plasma Apparent Clearance (CL/F) of Vemurafenib|Clearance of a drug is a measure of the rate at which a drug is removed (metabolized or eliminated by normal biological processes) from the blood. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population|||liters/hour||Geometric Coefficient of Variation|Geometric Mean
2639376|NCT01765543|Other Pre-specified|Plasma Elimination Half Life (t1/2) of Vemurafenib|Plasma elimination half-life is the time measured during drug elimination phase for the plasma drug concentration to decrease by one half.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population|||hours||Standard Deviation|Mean
2639377|NCT01765543|Other Pre-specified|Time to Reach Cmax (Tmax) of Vemurafenib|Tmax is the time from vemurafenib administration to reach Cmax for vemurafenib.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population|||hours||Full Range|Median
2639378|NCT01765543|Primary|Maximum Observed Plasma Concentration (Cmax) of Vemurafenib|Cmax is the maximum observed plasma vemurafenib concentration, presented in microgram per milliliter (mcg/mL).|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2639379|NCT01765543|Primary|Area Under the Plasma Concentration Time-curve From Zero to Extrapolated Infinite Time (AUC[0-inf]) of Vemurafenib|AUC(0-inf) is the AUC from time zero (pre-dose) to extrapolated infinite time (0-inf). AUC is a measure of the plasma concentration of a drug over time. AUC(0-inf) is presented in mcg*h/mL.|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|PK parameter population|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2639380|NCT01765543|Primary|Area Under the Plasma Concentration Time-curve From Zero to the Last Measurable Concentration Time Point (AUClast) of Vemurafenib|AUClast is the area under the vemurafenib plasma concentration versus time curve from time zero to the time of last measured concentration of vemurafenib (Tlast). Area under the curve (AUC) is a measure of the plasma concentration of a drug over time. AUClast is presented in micrograms times (*) hour per milliliter (mcg*h/mL).|Predose (0 hour), 1, 2, 4, 6, 8, 12, 24, 30-32, 48, 72, 96, 120, 168 hours post vemurafenib-dose on Day 1 (Period A) and Day 17 (Period C)|The pharmacokinetics (PK) parameter population included all participants who received both scheduled doses of vemurafenib and who provided adequate PK assessments to calculate important PK parameters.|||mcg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2639381|NCT01765530|Secondary|ETT Microbiology|For each patient a quantitative culture will be obtained from the ETT after extubation. Secretions will be retrieved from the ETT after CT scan and quantitative standard cultures will be performed. Microbial molecular diversity analysis and antibacterial resistance patterns will also be studied.|At extubation (An expected average of 5 days)||||Log colony form unit (CFU)/ mL||Standard Error|Mean
2652092|NCT01656252|Secondary|Phase II- Red Blood Cell Transfusion Requirements|To determine the impact of eltrombopag on red blood cell transfusion requirements.|62 months|||||||
2639382|NCT01765530|Primary|Percentage of Occlusion Assessed Using a High Definition Computed Tomography Imaging of the Extubated ETTs|The investigators will measure percentage of occlusion determined by the accumulation of secretion within the lumen of each ETT using a high definition Computed Tomography (CT) imaging of the extubated ETTs. The whole ETT will be analyzed through high-definition CT slices. 100% of occlusion means total occlusion of the lumen of the ETT and 0% means absence of any occlusion.|At extubation (An expected average of 5 days)||||percentage of occlusion||Standard Deviation|Mean
2639383|NCT01765465|Secondary|Laboratory Test Results of Postoperative 3-month(WBC Count)|"laboratory test results(WBC count) measured at postoperative 3-month of Rowachol group and placebo group.~each result is mean values."|postoperative 3-month||||cells (10^6/µl)||Standard Deviation|Mean
2639384|NCT01765465|Secondary|Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase)|"laboratory test results(liver function test such as Alkaline phosphatase, Aspartate aminotransferase, Alanine aminotransferase) measured at postoperative 3-month of Rowachol group and placebo group.~each result is mean values."|postoperative 3-month||||IU/dL||Standard Deviation|Mean
2639385|NCT01765465|Secondary|Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin)|"laboratory test results(liver function test such as total bilirubin, direct bilirubin) measured at postoperative 3-month of Rowachol group and placebo group.~each result is mean values."|postoperative 3-month||||mg/dL||Standard Deviation|Mean
2639386|NCT01765465|Primary|the Number of the Participants Have Postoperative RUQ Pain|"Right upper quadrant(RUQ) pain by European Organization for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ) C-30 No. 9, 19 at baseline and postoperative 3-month.~The pain score of individuals at postoperative 3-month is calculated by EORTC QLQ C-30 manual.~The pain score range is 0 to 100. Higher score means participants feel more pain(worse). If a participant's pain score is over 30, we define he/she has post operative RUQ pain. we use the number of the participants have post operative RUQ pain(score over 30) as the results."|postoperative 3-month||||number of participants|||Number
2639387|NCT01765426|Primary|Percentage of Participants With Unsolicited Vaccine-Related SAEs|A serious adverse event (SAE) is any AE in the view of the investigator that results in any of the following outcomes: death, life threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that may require medical or surgical intervention to prevent one of the other serious outcomes.|Dose 1 until 28 days after Dose 2 (Up to Day 118)|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
2639388|NCT01765426|Secondary|Percentage of Participants With Serotype-Specific DENVax RNA Detected Due to Each of the Four Dengue Vaccine Components After Each Vaccination|A quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay was used for detection and serotype identification of dengue viral ribonucleic acid (RNA) that is present in serum. A test for viremia is considered positive if the assay value is >= 3.6, which is the limit of quantification (LOQ), negative if the assay value was zero, and undetermined if the assay value is >0 but <3.6. The percentage of participants with positive results is reported.|Day 0 to Day 104|Full analysis set included all randomized participants who received at least one dose of study vaccine and for whom valid pre-dosing and at least one valid sample for immunogenicity (eg, seroconversion) was received.|||percentage of participants|||Number
2639389|NCT01765426|Secondary|Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes at Days 90 and 270|Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.|Days 90 and 270|Per Protocol Set included all randomized participants who completed the study without any major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2639390|NCT01765426|Secondary|Geometric Mean Titers of Neutralizing Antibody Titers Against Each of the Four Dengue Serotypes||Days 0, 28, 90, 118 and 270|Per Protocol Set included all randomized participants who completed the study without any major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
2639391|NCT01765426|Primary|Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After Second Injection|Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.|Day 118|Per Protocol Set included all randomized participants who completed the study without any major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2639392|NCT01765426|Primary|Seroconversion Rates (SCR) for Each of the Four Dengue Serotypes After First Injection|Seroconversion rate is defined as the percentage of participants with PRNT50 titer ≥ 10 or, if the titer on Day 0 is greater than 10, a four-fold rise in antibody titer.|Day 28|Per Protocol Set included all randomized participants who completed the study without any major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2639393|NCT01765426|Primary|Percentage of Participants With Abnormal Laboratory Values Reported as Adverse Events (AEs)|"The percentage of participants with any clinically relevant abnormal safety laboratory values (chemistry, hematology and urinalysis) collected from vaccine dose 1 (Day 0) through 28 days after dose 2 (Day 90) that were reported as AEs.~Abnormal laboratory values were reported as AEs based on the following criteria: Grade 3 (Severe) or Grade 4 (Life threatening) laboratory abnormalities based on DMID toxicity tables or laboratory abnormalities which resulted in a medical intervention."|118 Days|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
2639394|NCT01765426|Primary|Percentage of Participants With Unsolicited Vaccine-Related AEs Within 28 Days After Either Vaccine Dose by Maximum Severity|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE causally related to the study treatment as assessed by the investigator, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.|28 Days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
2639395|NCT01765426|Primary|Percentage of Participants With Solicited Local AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site AEs solicited from the participant using a memory aid included: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade.|14 days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
2639396|NCT01765426|Primary|Percentage of Participants With Solicited Systemic AEs as Reported by the Participant Using a Memory Aid 14 Days After Either Vaccine Dose by Maximum Severity|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Systemic AEs solicited from the participant using a memory aid included: body temperature, headache, myalgia (muscle pain), arthralgia (joint pain), photophobia (sensitivity to light), fatigue (tiredness), body rash, nausea and vomiting. Systemic AEs were graded using the scale: Grade 0= none to Grade 4=Life threatening. Systemic reactions are presented as percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.|14 days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
2639397|NCT01765426|Primary|Percentage of Participants With Unsolicited Adverse Events (AE) by Maximum Severity|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. AEs are graded from Grade 0=None to Grade 4=Life threatening. AEs are presented as the percentage of participants experiencing an AE, overall and by severity, using the participant's worst reported severity grade.|28 Days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
2639398|NCT01765426|Primary|Percentage of Participants With Local (Injection Site) Adverse Events (AEs) After Either Vaccine Dose by Maximum Severity as Assessed by the Clinical Staff|An AE is defined as any untoward medical occurrence in a patient or clinical trial participant administered a pharmaceutical product regardless of its causal relationship to the study treatment. Local injection site reactions were evaluated by the blinded clinical staff and include: erythema (redness), edema/induration (swelling), pain and pruritus (itching). Severity grades for erythema and edema are derived based on the Division of Microbiology and Infectious Diseases (DMID) toxicity grading longest diameters using the scale 0=none, 1=<15 millimeters (mm), 2=15 to 30 mm and 3=>30 mm (severe). Pain and itching were graded using the scale: 0=none to 4=requires ER visit or hospitalization. Local injection site reactions are presented as the percentage of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported.|28 Days after each dose|Safety analysis set included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.|||percentage of participants|||Number
2639399|NCT01765270|Secondary|Need for Antiarrhythmic Therapy||CABG surg to hospital discharge Approximately 5 days||||participants|||Number
2639400|NCT01765270|Secondary|Number of Participants Who Required Intraaortic Balloon Pump (IABP) Support||CABG to hospital discharge (Approximately 5 days)||||participants|||Number
2639401|NCT01765270|Secondary|Number of Participants Who Had an Episode of Hypoglycemia||baseline to end of study (Approximately 35-37 days)||||participants|||Number
2639402|NCT01765270|Secondary|Duration of Inotropic Support||CABG surg until hosp discharge (Approximately 5 days)||||hours||Standard Deviation|Mean
2639403|NCT01765270|Secondary|Number of Major Adverse Cardiac Events (MACE)|Death, myocardial infarction (MI), or New congestive heart failure (CHF)|Baseline to end of study (Approximately 35-37 days)||||Cardiac Events|||Number
2639404|NCT01765270|Secondary|Creatine Kinase-Myocardial Bands (CK-MB) Area Under the Curve||pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)||||ng*hr/mL||Inter-Quartile Range|Median
2639405|NCT01765270|Secondary|High Sensitive Troponin-I (hsTnT) Area Under the Curve||pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)||||ng*hr/mL||Inter-Quartile Range|Median
2639406|NCT01765270|Primary|Troponin I (TnI) Area Under the Curve (AUC)||pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)||||ng*hr/mL||Inter-Quartile Range|Median
2639407|NCT01765192|Secondary|Change From Baseline in Nighttime Asthma Symptoms|Patients will assess their daily night-time asthma symptoms according to the following scale: 0: No symptoms, slept through the night. 1: Slept well but some complaints in the morning. 2: Woke up once because of asthma (inclusive early awakening). 3: Woke up several times because of asthma (inclusive early awakening). 4: Bad night, awake most of the night because of asthma. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Nighttime Asthma Symptoms measurement as the covariate was used for analysis. A negative change from Baseline indicates improvement.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with data available for analysis after 4 weeks of treatment.|||units on a scale||Standard Error|Least Squares Mean
2639418|NCT01765153|Secondary|Change in Electromyography During Treadmill Walking at the End of 2 Months of Rest Period I|Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|Data was analysed for the 13 participants who provided CMR data in Training phase 1 to determine if training effect was maintained. 1 out 13 withdrew and 1 did not produce adequate reflex activity to allow analysis|||µV||Standard Deviation|Mean
2639408|NCT01765192|Secondary|Change From Baseline in Daytime Asthma Symptoms|Patients will assess their daily day-time asthma symptoms according to the following scale: 0: Very well, no symptoms. 1: One episode of wheezing, cough or breathlessness. 2: More than one episode of wheezing, cough or breathlessness without interfering with normal activities. 3: Wheezing, cough or short of breath most of the day which interfered to some extent with normal activities. 4: Asthma very bad. Unable to carry out daily activities as usual. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline Daytime Asthma Symptoms measurement as the covariate was used for analysis. A negative change from Baseline indicates improvement.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with data available for analysis after 4 weeks of treatment.|||units on a scale||Standard Error|Least Squares Mean
2639409|NCT01765192|Secondary|Change From Baseline in Morning Peak Expiratory Flow (PEF)|PEF will be measured at home using portable electronic peak flow meter. The participant will record PEF daily in the morning immediately after getting up. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline PEF measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with PEF data available for analysis after 4 weeks of treatment.|||L/min||Standard Error|Least Squares Mean
2639410|NCT01765192|Secondary|Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Peak Expiratory Flow (PEF)|PEF is a person's maximum speed of expiration. It measures the airflow through the bronchi and thus the degree of obstruction in the airways. PEF will be measured using spirometry in accordance with ATS/ERS consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline PEF measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with PEF data available for analysis after 4 weeks of treatment.|||liters/minute (L/min)||Standard Error|Least Squares Mean
2639411|NCT01765192|Secondary|Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Forced Expiratory Flow (FEF) 25-75%|FEF is a measure of how much air can be exhaled from the lungs. It is an indicator of obstruction of the smaller airways. FEF25-75% is the mid-flow rate or forced expiratory flow occurring in the middle 50% of the patient's exhaled volume, and will be measured using spirometry in accordance with ATS/ERS consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline FEF measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with FEF data available for analysis after 4 weeks of treatment.|||liters/second||Standard Error|Least Squares Mean
2639412|NCT01765192|Secondary|Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Forced Vital Capacity (FVC)|FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be measured using spirometry in accordance with ATS/ERS consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline FVC measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with FVC data available for analysis after 4 weeks of treatment.|||liters||Standard Error|Least Squares Mean
2639413|NCT01765192|Primary|Change From Baseline in Pre-Dose (Trough) Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 will be measured using spirometry in accordance with the American Thoracic Society / European Respiratory Society (ATS/ERS) consensus guidelines. An ANCOVA model with treatment sequence, treatment period, and study treatment as fixed factors with Baseline FEV1 measurement as the covariate was used for analysis.|Baseline (Days 1 and 56) and after 4 weeks of treatment (Days 28 and 84)|Full analysis set: All randomized participants, analyzed according to the randomized treatment with FEV1 data available for analysis after 4 weeks of treatment.|||liters||Standard Error|Least Squares Mean
2639414|NCT01765179|Secondary|Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population|The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114|The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.|||Participants|||Count of Participants
2639415|NCT01765179|Primary|Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL|The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114|The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.|||Participants|||Count of Participants
2639416|NCT01765153|Secondary|Change in Electromyography During Treadmill Walking at the End of 2 Months of Rest Period II|Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II|Data was analysed for the 13 participants who provided CMR data in Training phase 1. 1 out 13 withdrew and 3 did not produce adequate reflex activity to allow analysis.|||µV||Standard Deviation|Mean
2639417|NCT01765153|Secondary|Change in Electromyography During Treadmill Walking at 2 Months of Training Phase II|Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.|Change from Baseline II to 2 months of Training Phase II|Data from 5 participants could not be analysed due to absence of reflex, or difficulty with EMG signals. Remaining 13 were analysed.|||µV||Standard Deviation|Mean
2639598|NCT01763905|Secondary|Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639599|NCT01763905|Secondary|Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12||Week 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2639419|NCT01765153|Secondary|Change in Electromyography During Treadmill Walking at 2 Months of Training Phase I|Participants walk on a treadmill at a variety of speeds while we record surface electromyography from leg muscles and motion data from electrogoniometers place on the knees.|Change from Baseline I to 2 months of Training Phase I|Data from 6 participants could not be analysed due to absence of reflex, or difficulty with EMG signals. Remaining 13 were analysed.|||µV||Standard Deviation|Mean
2639420|NCT01765153|Secondary|Change in Transcranial Magnetic Stimulation (TMS) at the End of 2 Months of Rest Period II|Maximum evoked potentials were measured and compared to baseline measures for major muscle groups.|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II||||percentage of baseline MEP||Standard Error|Mean
2639421|NCT01765153|Secondary|Change in Transcranial Magnetic Stimulation (TMS) at 2 Months of Training Phase II|Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.|Change from Baseline II to 2 months of Training Phase II||||percentage of baseline mep||Standard Error|Mean
2639422|NCT01765153|Secondary|Change in Transcranial Magnetic Stimulation (TMS) at the End of 2 Months of Rest Period I|Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I||||percentage of baseline mep||Standard Error|Mean
2639423|NCT01765153|Secondary|Change in Transcranial Magnetic Stimulation (TMS) at 2 Months of Training Phase I|Single-pulse TMS is applied over the motor cortex, and electromyographic responses are recorded in the tibialis anterior muscles on both legs.|Change from Baseline I to 2 months of Training Phase I||||Percentage of baseline mep||Standard Error|Mean
2639424|NCT01765153|Secondary|Change in Cutaneomuscular Reflexes at the End of 2 Months of Rest Period II|Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II|Data was analysed for the 13 participants who provided CMR data in Training phase 1 to determine whether training effect was maintained. 1 out 13 withdrew and 3 did not produce adequate reflex activity to allow analysis.|||µV||Standard Deviation|Mean
2639425|NCT01765153|Secondary|Change in Cutaneomuscular Reflexes at 2 Months of Training Phase II|Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.|Change from Baseline II to 2 months of Training Phase II|Data from 5 participants could not be analysed due to absence of reflex, or difficulty with EMG signals. Remaining 13 were analysed.|||µV||Standard Deviation|Mean
2639426|NCT01765153|Secondary|Change in Cutaneomuscular Reflexes at the End of 2 Months of Rest Period I|Reflexes are elicited with electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG). Responses are typically recorded in standing.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|Data was analysed for the 13 participants who provided CMR data in Training phase 1 in order to dtermine if training effect was maintained. 1 out 13 withdrew and 1 did not produce adequate reflex activity to allow analysis|||µV||Standard Deviation|Mean
2639427|NCT01765153|Secondary|Change in Cutaneomuscular Reflexes at 2 Months of Training Phase I|Reflexes are elicited in standing by electrical stimulation (3 pulses) of the tibial nerve at the ankle using surface electrodes. Responses are recorded with surface electromyography (EMG) in µV.|Change from Baseline I to 2 months of Training Phase I|Data from 6 participants could not be analysed due to absence of reflex, or difficulty with EMG signals. Remaining 13 were analysed.|||µV||Standard Deviation|Mean
2639428|NCT01765153|Secondary|Change in Manual Muscle Test (MMT) at the End of 2 Months of Rest Period II|"The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally).~Results are reported as Final score - Initial score. A positive result indicates an increase in strength."|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II||||units on a scale||Standard Deviation|Mean
2639429|NCT01765153|Secondary|Change in Manual Muscle Test (MMT) at 2 Months of Training Phase II|The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally). Results are reported as Final score - Initial score. A positive result indicates an increase in strength.|Change from Baseline II to 2 months of Training Phase II|This measure was accidentally omitted for 1 participant at beginning of this phase. Data analysed for all participants who performed this measure.|||units on a scale||Standard Deviation|Mean
2639430|NCT01765153|Secondary|Change in Manual Muscle Test (MMT) at the End of 2 Months of Rest Period I|"The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally).~Results are reported as Final score - Initial score. A positive result indicates an increase in strength."|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|This measure was accidentally omitted for 1 participant at the end of this phase. Data analysed for all participants who performed this measure.|||units on a scale||Standard Deviation|Mean
2639600|NCT01763905|Secondary|Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)||Weeks 10 and 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2639431|NCT01765153|Secondary|Change in Manual Muscle Test (MMT) at 2 Months of Training Phase I|"The strength of each of 8 major muscle groups (per side) in the lower extremities is graded using the standard manual muscle testing technique. Strength is graded from 0 (no muscle activity detected) to 5 (strength with normal range for the muscle group). Scores from all muscle groups are added to obtain the total score. The total score ranges from 0 (unable to produce any muscle activity in all 8 muscle groups bilaterally) to 80 (normal strength in all 8 muscle groups bilaterally).~Results are reported as Final score - Initial score. A positive result indicates an increase in strength."|Change from Baseline I to 2 months of Training Phase I||||units on a scale||Standard Deviation|Mean
2639432|NCT01765153|Secondary|Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the End of 2 Months of Rest Period II|"A 20 question survey to measure current level of depressive symptoms.The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.~Results are reported as Final score - Initial score. A negative result indicates a lower level of depression."|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II||||units on a scale||Standard Deviation|Mean
2639433|NCT01765153|Secondary|Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 Months of Training Phase II|"A 20 question survey to measure current level of depressive symptoms.The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.~Results are reported as Final score - Initial score. A negative result indicates a lower level of depression."|Change from Baseline II to 2 months of Training Phase II||||units on a scale||Standard Deviation|Mean
2639434|NCT01765153|Secondary|Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at the End of 2 Months of Rest Period I|"A 20 question survey to measure current level of depressive symptoms.The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.~Results are reported as Final score - Initial score. A negative result indicates a lower level of depression."|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I||||units on a scale||Standard Deviation|Mean
2639435|NCT01765153|Secondary|Change in Center for Epidemiologic Studies - Depression Scale (CES-D) at 2 Months of Training Phase I|"A 20 question survey to measure current level of depressive symptoms. The participant ranks their emotional state or actions for each question on an ordinal scale of 0 to 3, with 0 indicating rarely or never and 3 being most of the time. A minimum score of 0 indicates no depressive symptoms, and a score of 10 or greater is considered indicative of depression. The max score for the scale is 60.~Results are reported as Final score - Initial score. A negative result indicates a lower level of depression."|Change from Baseline I to 2 months of Training Phase I||||units on a scale||Standard Deviation|Mean
2639436|NCT01765153|Secondary|Change in Activities-specific Balance Confidence Scale (ABC) at the End of 2 Months of Rest Period II|"A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.~Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability."|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II||||percentage of confidence in balance||Standard Deviation|Mean
2639437|NCT01765153|Secondary|Change in Activities-specific Balance Confidence Scale (ABC) at 2 Months of Training Phase II|"A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.~Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability."|Change from Baseline II to 2 months of Training Phase II||||Percentage of confidence in balance||Standard Deviation|Mean
2639438|NCT01765153|Secondary|Change in Activities-specific Balance Confidence Scale (ABC) at the End of 2 Months of Rest Period I|"A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.~Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability."|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I||||percentage of confidence in balance||Standard Deviation|Mean
2639439|NCT01765153|Secondary|Change in Activities-specific Balance Confidence Scale (ABC) at 2 Months of Training Phase I|"A survey with 16 questions regarding the participants confidence in their ability to perform specific tasks requiring balance. Participants rate their confidence as a percentage from 0% (no confidence in their ability to perform the task) to 100% 9 completely confident in their ability to complete the task safely. Total score is calculated as: Sum of item scores/16 and is expressed as a percentage.~Results are reported as Final score - Initial score. A positive result indicates a higher level of confidence in ability."|Change from Baseline I to 2 months of Training Phase I||||percentage of confidence in balance||Standard Deviation|Mean
2639450|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at the End of 2 Months of Rest Period I|Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|Measure was added to study protocol midway through study. 4 out of 18 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.|||m/s||Standard Deviation|Mean
2639440|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at the End of 2 Months of Rest Period II|"Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.~Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II||||units on a scale||Standard Deviation|Mean
2639441|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at 2 Months of Training Phase II|"Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.~Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from Baseline II to 2 months of Training Phase II|Measure was added to study protocol midway through study. 1 out of 18 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.|||units on a scale||Standard Deviation|Mean
2639442|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at the End of 2 Months of Rest Period I|"Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.~Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I|Measure was added to study protocol midway through study. 2 out of 17 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.|||units on a scale||Standard Deviation|Mean
2639443|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Maximum [WISCI-II (Max)] at 2 Months of Training Phase I|"Participants are scored from 0 to 20 based on the least amount of assistance/aid they require to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.~Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from Baseline I to 2 months of Training Phase I|Measure was added to study protocol midway through study. 3 out of 19 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.|||units on a scale||Standard Deviation|Mean
2639444|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at the End of 2 Months of Rest Period II|"Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.~Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II||||units on a scale||Standard Deviation|Mean
2639445|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at 2 Months of Training Phase II|"Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.~Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from Baseline II to 2 months of Training Phase II||||units on a scale||Standard Deviation|Mean
2639446|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at the End of 2 Months of Rest Period I|"Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.~Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I||||units on a scale||Standard Deviation|Mean
2639447|NCT01765153|Secondary|Change in Walking Index for Spinal Cord Injury Version II Self-selected (WISCI-II ss) at 2 Months of Training Phase I|"Participants are scored from 0 to 20 based on the walking aid they select to walk a distance of 10 meters. Walking aids and physical assistance provided are ranked on an ordinal scale from 1 to 20. A score of 0 indicates the participant is unable to walk 10 m, 20 indicates no aids are required to complete the task.~Results are reported as Final score - Initial score. A positive result indicates that less assistance was required."|Change from Baseline I to 2 months of Training Phase I||||units on a scale||Standard Deviation|Mean
2639448|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at the End of 2 Months of Rest Period II|Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II|Measure was added to study protocol midway through study. 2 out of 16 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.|||m/s||Standard Deviation|Mean
2639449|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at 2 Months of Training Phase II|Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from Baseline II to 2 months of Training Phase II|Measure was added to study protocol midway through study. 3 out of 18 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.|||m/s||Standard Deviation|Mean
2639451|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Fast Speed [10MWT(f)] at 2 Months of Training Phase I|Participants walk as quickly as they are able to along a 14 meter path on a smooth floor. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from Baseline I to 2 months of Training Phase I|Measure was added to study protocol midway through study. 5 out of 19 participants did not complete this measure at this time point. Data analysed for all participants who performed this measure.|||m/s||Standard Deviation|Mean
2639452|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at the End of 2 Months of Rest Period II|Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II||||m/s||Standard Deviation|Mean
2639453|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at 2 Months of Training Phase II|Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from Baseline II to 2 months of Training Phase II||||m/s||Standard Deviation|Mean
2639454|NCT01765153|Secondary|Change in 10 Meter Walk Test at a Self-selected Speed [10MWT(ss)] at the End of 2 Months of Rest Period I|Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I||||m/s||Standard Deviation|Mean
2639455|NCT01765153|Secondary|Change in 10 Metre Walk Test at a Self-selected Speed [10MWT(ss)] at 2 Months of Training Phase I|Participants walk along a 14 meter path on a smooth floor at a comfortable pace. The middle 10 m is timed. Speed over 10 m is calculated as 10 m/Time. Results are calculated as: Final speed - initial speed.|Change from Baseline I to 2 months of Training Phase I||||m/s||Standard Deviation|Mean
2639456|NCT01765153|Secondary|Change in 6 Minute Walk Test (6MWT) at the End of 2 Months of Rest Period II|Participants walk for as far as possible in 6 min along a 25m hallway. Total distance walked in the time is measured. Results are calculated as : Distance walked at end of period - Distance walked at beginning of period.|Change from the end of Phase II training to 2 months of Rest Period II||||metres||Standard Deviation|Mean
2639457|NCT01765153|Secondary|Change in 6 Minute Walk Test (6MWT) at 2 Months of Training Phase II|Participants walk for as far as possible in 6 min along a 25m hallway. Total distance walked in the time is measured. Results are calculated as : Distance walked at end of period - Distance walked at beginning of period.|Change from Baseline II to 2 months of Training Phase II||||metres||Standard Deviation|Mean
2639458|NCT01765153|Secondary|Change in 6 Minute Walk Test (6MWT) at the End of 2 Months of Rest Period I|Participants walk for as far as possible in 6 min along a 25m hallway. Total distance walked in the time is measured. Results are calculated as : Distance walked at end of period - Distance walked at beginning of period.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I||||metres||Standard Deviation|Mean
2639459|NCT01765153|Secondary|Change in 6 Minute Walk Test (6MWT) at 2 Months of Training Phase I|Participants walk for as far as possible in 6 min along a 25m hallway.|Change from Baseline I to 2 months of Training Phase I||||metres||Standard Deviation|Mean
2639460|NCT01765153|Secondary|Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period II|This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.|Change from the end of Phase II training (measured at 2 months of Training Phase II) to 2 months of Rest Period II||||units on a scale||Standard Deviation|Mean
2639461|NCT01765153|Secondary|Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase II|This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.|Change from Baseline II to 2 months of Training Phase II||||units on a scale||Standard Deviation|Mean
2639462|NCT01765153|Secondary|Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at the End of 2 Months of Rest Period I|This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.|Change from the end of Phase I training (measured at 2 months of Training Phase I) to 2 months of Rest Period I||||units on a scale||Standard Deviation|Mean
2639601|NCT01763905|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
2639463|NCT01765153|Secondary|Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at 2 Months of Training Phase I|This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.|Change from Baseline I to 2 months of Training Phase I||||units on a scale||Standard Deviation|Mean
2639464|NCT01765153|Primary|Change in Spinal Cord Injury - Functional Ambulation Profile (SCI-FAP) at Completion of Study|This is a 7 item, timed walking test. Participants perform each of the walking tasks and the time to complete each task is recorded. Maximum times are set for each task. An assistance category is assigned based on the walking aids used, with 1 being no aid and 6 being unable to complete the task. A score for each item is calculated as: Time x Assistance factor/Mean able bodied time. A composite (single) score is obtained by summing the scores for all 7 items. The maximum score for the scale is 2100 indicating that the participant was unable to complete any of the 7 tasks within the allowed time. A minimum score of 7 indicates that all tasks were performed with no aids and at the mean able-bodied time. Results are reported as a measure of change: Final score - initial score. A negative result indicates improvement.|Change from Baseline I to the end of the study (i.e., end of Rest Period II, which was ~8 months after the beginning of the study)||||units on a scale||Standard Deviation|Mean
2639465|NCT01764997|Secondary|Change From Baseline in DAS28-CRP Score at Week 12||Baseline, Week 12|As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
2639466|NCT01764997|Secondary|Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 12 and Week 24||Week 12 and Week 24|As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
2639467|NCT01764997|Secondary|Number of Participants With at Least 20% Improvement in American College of Rheumatology (ACR20), at Least 50% Improvement in ACR (ACR50) and at Least 70% Improvement in ACR (ACR70) Efficacy Response Rates at Week 12 and Week 24||Week 12 and Week 24|As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
2639468|NCT01764997|Primary|Change From Baseline in Disease Activity Score for 28 Joints - C-Reactive Protein (DAS28-CRP) Score at Week 24||Baseline, Week 24|As the number of participants randomized fell well below target (43 vs. 699), the efficacy data were not systematically collected or cleaned and no datasets have been created to report.||||||
2639469|NCT01764945|Primary|AUC0-tz|"Area under the concentration-time curve of the analyte (faldaprevir) in plasma over the time interval from 0 to the time of the last quantifiable data point.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after administration of faldaprevir on Day 1.|PK set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2639470|NCT01764945|Primary|Cmax|Maximum measured concentration of the analyte (faldaprevir) in plasma. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.|-1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h after administration of faldaprevir on Day 1.|PK set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2639471|NCT01764945|Primary|AUC0-∞|"Area under the concentration-time curve of the analyte (faldaprevir) in plasma over the time interval from 0 extrapolated to infinity.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|-1:00, 1:00, 2:00, 3:00, 4:00, 5:00, 6:00, 7:00, 8:00, 9:00, 10:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00 h (hours) after administration of faldaprevir on Day 1.|Pharmacokinetic analysis set (PK set) includes all subjects who provided evaluable data for at least 1 evaluable observation for a PK endpoint in at least 1 treatment period.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2639472|NCT01764919|Other Pre-specified|Explore the Performance of [124I]FIAU PET-CT Compared to MRI in Detecting Osteomyelitis by Chronic Kidney Disease (CKD) Stage (Stage 1+2, Stage 3, and Stage 4+5).||-2 hours to 72 hours post dose [124I]FIAU|No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed.||||||
2639473|NCT01764919|Secondary|Assess Any Additional Information That [124I]FIAU PET-CT Scanning Provides Compared to MRI|Additional information on the extent and localization of infection will be compared to MRI.|-2 to 72 hours post dose [124I]FIAU|No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed.||||||
2639474|NCT01764919|Secondary|Compare the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning to Gadolinium-enhanced (GE) Magnetic Resonance Imaging (MRI) and Non-GE-MRI Scanning in Detecting Osteomyelitis in Patients With Diabetic Foot Infection|All PET-CT images will be evaluated centrally and independently by a single radiologist. Diagnosis of osteomyelitis based on PET-CT will be compared with MRI which is currently the test of choice to diagnose osteomyelitis in diabetic foot infection.|-2 to 72 hours post dose [124I]FIAU|No correlation was seen between FIAU uptake and bone biopsy results (the standard of truth). The secondary and exploratory efficacy endpoints were not assessed.||||||
2639475|NCT01764919|Secondary|Assess the Safety and Tolerability of [124I]FIAU|Safety will be monitored for all subjects for the duration of their study participation. Safety will be assessed by monitoring of adverse events,vital signs, physical exams, and clinical laboratory tests including CBC and serum chemistry.|30 +/- 2 days||||participants with adverse events|||Number
2639602|NCT01763905|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
2639476|NCT01764919|Primary|Assess the Sensitivity and Specificity of [124I]FIAU PET-CT Scanning in Detecting Osteomyelitis as Determined by Bone Biopsy in Patients With Diabetic Foot Infection.|A bone biopsy was obtained through a noninfected area and submitted for histology and microbiologic culture. Cultures were also to be obtained by biopsy after debridement of the ulcer from a clean base. Subjects were dosed with [124I]FIAU. PET-CT scanning were performed. All PET, PET-CT, and CT images, both attenuation corrected and uncorrected, were to be evaluated centrally and independently. Results from the bone biopsies were not available to the central reader of the PET-CT images. The sensitivity and specificity of [124I]FIAU PET-CT scanning in detecting osteomyelitis was determined based on its correlation with bone biopsy, the truth standard.|30 hours||||participants|||Number
2639477|NCT01764841|Secondary|Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at End of Treatment (Week 44/46)|FEV1 was defined as the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration, expressed in liters at body temperature and ambient pressure saturated with water vapor (BTPS).|Baseline and end of treatment (Week 44/46)|FAS with participants evaluable for this outcome measure.|||Liter||Standard Deviation|Mean
2639478|NCT01764841|Secondary|Mean Change From Baseline in Patient Reported Outcome Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score at End of Treatment (Week 44/46)|The QoL-B was a disease-specific questionnaire developed for non-Cystic fibrosis Bronchiectasis. It covers 8 dimensions: physical functioning, role functioning, emotional functioning, social functioning, vitality, treatment burden, health perceptions, and respiratory symptoms. Each dimension was scored separately on a scale of 0 to 100, and higher scores represent better outcomes. For this outcome measure, the respiratory symptoms domain score was reported.|Baseline and end of treatment (Week 44/46)|FAS with participants evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
2639479|NCT01764841|Secondary|Percentage of Participants With Occurrence of New Pathogens Present at End of Treatment (Week 44/46)|New pathogens were any of the pre-specified organisms not cultured before start of study medication. There was no imputation for participants who discontinued the study prematurely.|End of treatment (Week 44/46)|Full analysis set (FAS) included participants who were randomized.|||Percentage of Participants|||Number
2639480|NCT01764841|Secondary|Mean Change From Baseline in Patient Reported Outcome Saint George's Respiratory Questionnaire (SGRQ) Symptoms Component Score at End of Treatment (Week 44/46)|The SGRQ was a validated, disease-specific instrument that measures health-related quality of life (HRQoL) in adults with chronic obstructive pulmonary disease (COPD) and asthma and was later validated for use in bronchiectasis. The SGRQ covers 3 dimensions: symptoms, activity and impact on daily life. To determine the outcome, a score ranging from 1 to 100 was calculated for each individual domain and for the total score, and smaller scores indicate better health status. For this outcome measure, the symptoms component score was reported.|Baseline and end of treatment (Week 44/46)|FAS with participants evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
2639481|NCT01764841|Secondary|Percentage of Participants With Pathogen Eradication at End of Treatment (Week 44/46)|Pathogen eradication was defined as a negative culture result for all pre-specified pathogens at end of treatment (week 44 or 46 depending on treatment regimen) that were present in the participant at baseline. There was no imputation for participants who discontinued the study prematurely.|End of treatment (Week 44/46)|Full analysis set (FAS) included participants who were randomized.|||Percentage of Participants|||Number
2639482|NCT01764841|Secondary|Number of Participants With Exacerbation Events With Worsening of at Least One Sign/Symptom Over 48 Weeks|For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and worsening of at least one sign/symptom over 48 weeks.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.|||Participants|||Number
2639483|NCT01764841|Secondary|Number of Participants With Exacerbation Events With Worsening of at Least Three Signs/Symptoms Over 48 Weeks|For this outcome measure, exacerbation events were defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms over 48 weeks.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.|||Participants|||Number
2639484|NCT01764841|Primary|Time to First Exacerbation Event Within 48 Weeks|Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.|Up to Week 48|Full analysis set (FAS) included participants who were randomized.|||Days||97.5% Confidence Interval|Median
2639485|NCT01764685|Primary|Number of Heavy Drinking Days Per Week by Medication Group|Total number of heavy drinking days (>4 drinks for men; >3 drinks for women) for the placebo + medical management group during the study period. No data analysis will be done due to the small sample size and fact that all subjects received placebo study medication.|11-week study period|Data was only collected on 3 of the 4 subjects.|||Number of heavy drinking days/week|||Number
2639486|NCT01764659|Primary|Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation|Image quality (anatomic details, motion artifacts, beam hardening and enhancement of pancreatic tissue and tumor were scored from 1 to 5, with 1 being very poor and 5 being excellent), CT number of pancreas and tumor, tumor-to-pancreas contrast, image noise and contrast-to-noise ration (CNR) were compared among contrast-enhanced (CE) 4DCT, CE 3DCT and 4DCT without contrast enhancement.|1 year|Image data of 10 patients (of the 12 patients who completed the study) was good for analysis.|||contrast to noise ratio||Standard Deviation|Mean
2639487|NCT01764659|Primary|Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation|Image quality (anatomic details, motion artifacts, beam hardening and enhancement of pancreatic tissue and tumor were scored from 1 to 5, with 1 being very poor and 5 being excellent), CT number of pancreas and tumor, tumor-to-pancreas contrast, image noise and contrast-to-noise ration (CNR) were compared among contrast-enhanced (CE) 4DCT, CE 3DCT and 4DCT without contrast enhancement.|1 year|Image data of 10 patients (of the 12 patients who completed the study) was good for analysis.|||HU||Standard Deviation|Mean
2639603|NCT01763905|Primary|Percent Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set (all randomized participants who received at least 1 dose of investigational product (subcutaneously or orally)) with available data (no imputation was performed).|||percent change||Standard Error|Least Squares Mean
2639488|NCT01764659|Primary|Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation|Image quality (anatomic details, motion artifacts, beam hardening and enhancement of pancreatic tissue and tumor were scored from 1 to 5, with 1 being very poor and 5 being excellent), CT number of pancreas and tumor, tumor-to-pancreas contrast, image noise and contrast-to-noise ration (CNR) were compared among contrast-enhanced (CE) 4DCT, CE 3DCT and 4DCT without contrast enhancement.|1 year|Image data of 10 patients (of the 12 patients who completed the study) was good for analysis.|||units on a scale||Standard Deviation|Mean
2639489|NCT01764633|Secondary|Time to First Ischemic Fatal or Non-Fatal Stroke or Transient Ischemic Attack|"All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions.~Ischemic stroke was defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue. Transient ischemic attack (TIA) was defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction.~Time to first ischemic fatal or non-fatal stroke or TIA was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using KM analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date."|Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.|All randomized participants; the number of participants entered at each time point represents the number of participants at risk.|||percentage of participants||95% Confidence Interval|Number
2639490|NCT01764633|Secondary|Time to Cardiovascular Death or First Hospitalization for Worsening Heart Failure|"All events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions.~HF hospitalization was defined as an event that met all of the following criteria:~Admitted to hospital with a primary diagnosis of HF~In hospital for at least 24 hours~Documented new or worsening symptoms due to HF, including at least 1 of the following:~Dyspnea~Decreased exercise tolerance~Fatigue~Other symptoms of worsened end-organ perfusion or volume overload~Evidence of new or worsening HF consisting of at least 2 physical exam findings or 1 physical exam finding and at least 1 laboratory criterion~Received new or increased treatment for HF. Time to CV death or first hospitalization for worsening HF was defined as the time from randomization to the first occurrence of any component of the endpoint analyzed using KM survival analysis. Participants with no event were censored based on last non-fatal potential endpoint collection date."|Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.|All randomized participants; the number of participants entered at each time point represents the number of participants at risk.|||percentage of participants||95% Confidence Interval|Number
2639491|NCT01764633|Secondary|Time to First Coronary Revascularization|"All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction.~Time to first coronary revascularization was defined as the time from randomization to the date of the coronary revascularization and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date."|Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.|All randomized participants; the number of participants entered at each time point represents the number of participants at risk.|||percentage of participants||95% Confidence Interval|Number
2639492|NCT01764633|Secondary|Time to First Stroke|"All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction.~Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.~Time to first stroke was defined as the time from randomization to the date of the stroke and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date."|Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.|All randomized participants; The number of participants entered at each time point represents the number of participants at risk.|||percentage of participants||95% Confidence Interval|Number
2639493|NCT01764633|Secondary|Time to First Myocardial Infarction|"All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction.~The diagnosis of myocardial infarction required the combination of:~Evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and~Supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery Imaging.~Time to first myocardial infarction was defined as the time from randomization to the date of the first MI and was analyzed using Kaplan-Meier survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date."|Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.|All randomized participants; The number of participants entered at each time point represents the number of participants at risk.|||percentage of participants||95% Confidence Interval|Number
2639518|NCT01764386|Secondary|Change in Waist Circumference From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||cm||Standard Error|Least Squares Mean
2639494|NCT01764633|Secondary|Time to All Cause Death|Time to all-cause death was defined as the time from randomization to the date of death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date.|Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.|All randomized participants; The number of participants entered at each time point represents the number of participants at risk.|||percentage of participants||95% Confidence Interval|Number
2639495|NCT01764633|Secondary|Time to Cardiovascular Death|"All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction.~Cardiovascular death includes death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes.~Time to cardiovascular death was defined as the time from randomization to the date of cardiovascular death and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on the last confirmed survival status date."|Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.|All randomized participants; The number of participants entered at each time point represents the number of participants at risk.|||percentage of participants||95% Confidence Interval|Number
2639496|NCT01764633|Secondary|Time to Cardiovascular Death, Myocardial Infarction, or Stroke|"All deaths and potential endpoint events were adjudicated by an independent external CEC led by the TIMI Study Group, using standardized definitions based on the Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction. Time to cardiovascular death, myocardial infarction, or stroke was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date."|Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.|All randomized participants; The number of participants entered at each time point represents the number of participants at risk.|||percentage of participants||95% Confidence Interval|Number
2639497|NCT01764633|Primary|Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization|"All deaths and potential endpoint events were adjudicated by an independent external Clinical Events Committee (CEC) led by the Thrombolysis in Myocardial Infarction (TIMI) Study Group, using standardized definitions based on the Standardized Definitions for Cardiovascular and Stroke End Point Events in Clinical Trials and the Third Universal Definition of Myocardial Infarction.~Time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization was defined as the time from randomization to the first occurrence of any component of the composite endpoint and was analyzed using Kaplan-Meier (KM) survival analysis. KM estimates of the percentage of participants with an event are reported. Participants with no event were censored based on last non-fatal potential endpoint collection date."|Events that occurred from randomization to the last confirmed survival status date; the median duration of follow-up was 26 months. KM estimates at 6, 12, 18, 24, 30 and 36 months are reported.|All randomized participants; The number of participants entered at each time point represents the number of participants at risk.|||percentage of participants||95% Confidence Interval|Number
2639498|NCT01764607|Secondary|Evaluation of Skin Tumor for Squamous Cell Skin Carcinoma|Tumor will be analyzed at baseline and time of surgical removal by both laboratory and microscopic testing.|At baseline and time of surgical removal (5 weeks).||||percentage of baseline size|||Number
2639499|NCT01764607|Primary|Measure of Squamous Cell Skin Carcinoma in Patients|Baseline: Measuring of squamous cell skin carcinoma, Week 5: Measuring and surgical removal of squamous cell skin cancer with microscopic evaluation, and in 1 year.|Baseline, time of surgical removal (5 weeks) and 1 year.||||mm|||Number
2639500|NCT01764464|Secondary|Insomnia Severity Index (ISI)|The ISI has 7 questions with each question ranging from 0-4 for a total of 28 points with higher scores indicating more severe insomnia.|6 weeks||||units on a scale||Standard Deviation|Mean
2639501|NCT01764464|Secondary|Mean Change in Modified Brief Pain Inventory- Short Form (mBPI-sf)|The mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven 11-point pain interference scales (0 indicating no interference and 10 indicating complete interference). The scale ranges from 0 to 70. Higher scores indicate worse outcome.|baseline to 6 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2639502|NCT01764464|Secondary|Mean McGill Pain Questionnaire-2 (MPQ-2)|The McGill Pain questionnaire is 22 questions where patient rate their pain symptoms with each question scaled 0-10 for a total 220 points where a higher score indicates worse outcome.|6 weeks||||units on a scale||Standard Deviation|Mean
2639503|NCT01764464|Secondary|Mean Change in Patient Global Assessment (PGA)|Subjects will be asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA is measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor.|baseline to 6 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2639504|NCT01764464|Secondary|Mean Change in Visual Analog Scale (VAS)|The VAS asks subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain.|baseline to 6 weeks||||mm||95% Confidence Interval|Least Squares Mean
2639505|NCT01764464|Primary|Mean Change in Numeric Rating Scale (NRS)|Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable).|baseline to 6 weeks||||units on a scale||95% Confidence Interval|Least Squares Mean
2639586|NCT01763905|Secondary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639506|NCT01764386|Secondary|Change in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 26|Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) is a self-reported assessment of perceived effect of weight on quality of life. It consists of 31 items organized in 5 domains (physical function, self-esteem, sexual life, public distress and work). IWQOL-Lite total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment.|Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||units on a scale||Standard Error|Least Squares Mean
2639507|NCT01764386|Secondary|Change in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26|Arizona Sexual Experiences (ASEX) scale is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.|Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||units on a scale||Standard Error|Least Squares Mean
2639508|NCT01764386|Secondary|Change in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26|The BES is a 16-item questionnaire that identifies different levels of binge-eating severity, with total scores ranging between 0-46. BES scores were categorized as follows: None = Scores ≤17 indicated no significant binge eating, Moderate = scores from 18 to 26 (inclusive), Severe = scores ≥27 indicated severe levels of binge eating.|Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||units on a scale||Standard Error|Least Squares Mean
2639509|NCT01764386|Secondary|Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26|HOMA-IR is an insulin sensitivity index that is calculated as HOMA-IR = (Glucose * Insulin) / 405, where glucose is in mass units (mg/dL) and insulin is in µIU/mL. Higher values indicate lower insulin sensitivity.|Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||units on a scale||Standard Error|Least Squares Mean
2639510|NCT01764386|Secondary|Change Fasting Insulin From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||uIU/mL||Standard Error|Least Squares Mean
2639511|NCT01764386|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||mg/dL||Standard Error|Least Squares Mean
2639512|NCT01764386|Secondary|Change in Heart Rate From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||bpm||Standard Error|Least Squares Mean
2639513|NCT01764386|Secondary|Change in Diastolic Blood Pressure From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||mm Hg||Standard Error|Least Squares Mean
2639514|NCT01764386|Secondary|Change in Systolic Blood Pressure From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||mm Hg||Standard Error|Least Squares Mean
2639515|NCT01764386|Secondary|Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||mg/dL||Standard Error|Least Squares Mean
2639516|NCT01764386|Secondary|Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||mg/dL||Standard Error|Least Squares Mean
2639517|NCT01764386|Secondary|Change in Fasting Triglycerides From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||mg/dL||Standard Error|Least Squares Mean
2639519|NCT01764386|Secondary|Absolute Change in Body Weight From Baseline to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||kg||Standard Error|Least Squares Mean
2639520|NCT01764386|Secondary|Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||percentage of participants|||Number
2639521|NCT01764386|Secondary|Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||percentage of participants|||Number
2639522|NCT01764386|Secondary|Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||percentage of participants|||Number
2639523|NCT01764386|Primary|Percent Change in Body Weight From Baseline (Day 1) to Week 26||Baseline to Week 26|The Week 26 Per Protocol (PP) population comprised subjects from the mITT population (i.e., ITT subjects with their Week 2 study visit, with baseline [BL] and at least 1 post-BL body weight measured) who had completed the study through Week 26 in compliance with the protocol. Subjects in the NB + CLI group had to be on study medication at Week 26.|||percent change in body weight||Standard Error|Least Squares Mean
2639524|NCT01764256|Secondary|Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain|Seroresponse was defined as as a four-fold increase in antibody titers between baseline and 4-weeks post-third injection.|4 weeks post 3rd immunization (84 days)||||Participants|||Count of Participants
2639525|NCT01764256|Secondary|Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA)|Measured from sera taken on Days 0, 28, 56 and 84 (before the first injection and 4 weeks after each injection).|Days 0, 28, 56 and 84 (before the first injection and 4 weeks after each injection)|Included subjects that received vaccinations (see participant flow for reasons why some subjects did not receive all vaccinations).|||titer||95% Confidence Interval|Geometric Mean
2639526|NCT01764256|Secondary|Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG)|Measured from sera taken on Days 0, 28, 56 and 84 (before the first injection and 4 weeks after each injection).|Days 0, 28, 56 and 84 (before the first injection and 4 weeks after each injection)|Included subjects that received vaccinations (see participant flow for reasons why some subjects did not receive all vaccinations).|||titer||95% Confidence Interval|Geometric Mean
2639527|NCT01764256|Secondary|Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses|Seroresponse was defined as as a four-fold increase in antibody titers between baseline and 4-weeks post-third injection.|4 weeks post 3rd immunization (84 days)||||Participants|||Count of Participants
2639528|NCT01764256|Primary|Maximum Local or Systemic Reactogenicity After the Third Vaccination|"For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination.~Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy."|7 days post Vaccination #3 on Day 56|44 subjects received third vaccination (4 less than Analysis Population Description). 2 subjects lost in Placebo group, one due to pain, swelling (after vaccination #2) and 1 due to incarceration. 1 subject lost from 10 μg cohort due to illness, 1 subject lost in 30 μg cohort because did not continue to meet inclusion/exclusion criteria.|||Participants|||Count of Participants
2639529|NCT01764256|Primary|Maximum Local or Systemic Reactogenicity After the Second Vaccination|"For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination.~Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy."|7 days post Vaccination #2 on Day 35|47 subjects received the second vaccination (one less than Analysis Population Description). Subject in the placebo group withdrew Completed vaccination # 1 but withdrew due to moderate pain, tenderness and swelling, before Vaccination 2.|||Participants|||Count of Participants
2639530|NCT01764256|Primary|Maximum Local or Systemic Reactogenicity After the First Vaccination|"For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination.~Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy."|7 days post Vaccination #1 on Day 0||||Participants|||Count of Participants
2639531|NCT01764256|Primary|Maximum Local or Systemic Reactogenicity After Any Vaccination|"For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination.~Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy."|7 days after each vaccination (Day 7, 35, 63)||||Participants|||Count of Participants
2639587|NCT01763905|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639532|NCT01764256|Primary|Maximum Severity of Adverse Events After Any Vaccination|Adverse events were collected through 28 days following the final study injection and were graded for severity. Unsolicited adverse events were also assessed for relationship to vaccine. A final follow-up contact was attempted 6 months following the final study injection to inquire about new chronic health conditions, serious health events, and hospitalizations.|6 months after final vaccination (224 days)||||Participants|||Count of Participants
2639533|NCT01764022|Secondary|Tmax After the Sixth Test Drug Administration|Secondary outcome measure for PK substudy. Time to reach peak serum concentration of trastuzumab after the sixth administration of BCD-022 + paclitaxel or Herceptin® + paclitaxel|Up to Day 127|Patients who received six dose of study drug and had missed <= 1 blood sample collection to analyse pharmacokinetics.|||hour||Inter-Quartile Range|Median
2639534|NCT01764022|Secondary|Cmax After the Sixth Test Drug Administration|Secondary outcome measure for PK substudy. Peak serum concentration of trastuzumab after the sixth administration of BCD-022 + paclitaxel or Herceptin® + paclitaxel.|Up to Day 127|Patients who received six dose of study drug and had missed <= 1 blood sample collection to analyse pharmacokinetics.|||ng/ml||Inter-Quartile Range|Median
2639535|NCT01764022|Secondary|T1/2 After the First Test Drug Administration|Secondary outcome measure for PK substudy. Half-life period of trastuzumab after the first administration of BCD-022 + paclitaxel or Herceptin® + paclitaxel.|Up to Day 22|Patients who received one dose of study drug and after 504 hours after the injection had missed <= 1 blood sample collection to analyse pharmacokinetics.|||hours||Inter-Quartile Range|Median
2639536|NCT01764022|Secondary|Tmax After the First Test Drug Administration|Secondary outcome measure for PK substudy. Time to reach peak serum concentration of trastuzumab after the first administration of BCD-022 + paclitaxel or Herceptin® + paclitaxel|Up to Day 22|Patients who received one dose of study drug and after 504 hours after the injection had missed <= 1 blood sample collection to analyse pharmacokinetics.|||hours||Inter-Quartile Range|Median
2639537|NCT01764022|Secondary|Cmax After the First Test Drug Administration|Secondary outcome measure for PK substudy. Peak serum concentration of trastuzumab after single administration of BCD-022 + paclitaxel or Herceptin® + paclitaxel|Up to Day 22|Patients who received one dose of study drug and after 504 hours after the injection had missed <= 1 blood sample collection to analyse pharmacokinetics.|||ng/ml||Inter-Quartile Range|Median
2639538|NCT01764022|Secondary|Occurrence of Neutralizing Anti-trastuzumab Antibodies|Secondary outcome measure for immunogenicity assessment. Patient was suggested as NAB-positive if neutralizing anti-trastuzumab antibodies were detected at any of the specified timepoints. Total number of NAB-positive patients in each are presented.|Day 1 (before the drug administration), Day 14, 64, 127 and 154|Patients who received at least one injection of study drug|||participants|||Number
2639539|NCT01764022|Secondary|Treatment Discontinuation Due to AE/SAE|Secondary outcome measure for safety evaluation|Day 127|Patients who received at least one injection of study drug.|||participants|||Number
2639540|NCT01764022|Secondary|Treatment Postponed Due to AE/SAE|Secondary outcome measure for safety evaluation|Day 127|Patients who received at least one injection of study drug.|||participants|||Number
2639541|NCT01764022|Secondary|Progression Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.|||Participants|||Count of Participants
2639542|NCT01764022|Secondary|Stabilization Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.|||Participants|||Count of Participants
2639543|NCT01764022|Secondary|Partial Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.|||Participants|||Count of Participants
2639544|NCT01764022|Secondary|Complete Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.|||Participants|||Count of Participants
2639545|NCT01764022|Primary|Area Under the Curve After the First Test Drug Administration|Primary outcome measure for pharmacokinetics (PK) substudy. AUC(0-504) of trastuzumab in HER2(+) mBC patients after first administration of BCD-022 with paclitaxel or Herceptin® with paclitaxel.|up to Day 22, after the first trastuzumab administration (time points for blood samples: 0 h 1.5 h, 3 h, 4.5 h, 6 h, 24 h, 96 h, 168 h, 336 h and 504 h)|Patients who received one dose of study drug and after 504 hours after the injection had missed <= 1 blood sample collection to analyse pharmacokinetics.|||(ng/ml)*hour||Inter-Quartile Range|Median
2639546|NCT01764022|Primary|Overall Response Rate|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed."|Day 127|The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.|||Participants|||Count of Participants
2639547|NCT01763996|Secondary|Exercise Duration|Exercise duration is the exercise time in seconds during ETT. Data at the end of each period was combined for the febuxostat and the placebo arms.|At the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.|||seconds||95% Confidence Interval|Least Squares Mean
2639548|NCT01763996|Secondary|Time to Onset of Angina During Exercise Treadmill Test at the End of the Administration of Febuxostat and Placebo|Time in seconds to ischemic chest pain/ angina during ETT. Data at the end of each period was combined for the febuxostat and the placebo arms|At the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with ischemic chest pain.|||seconds||Standard Deviation|Mean
2639549|NCT01763996|Secondary|Percentage of Participants Stopping Exercise Treadmill Test Due to Angina at the End of the Administration of Febuxostat and Placebo|An exercise treadmill test (modified Bruce protocol) was performed. Data at the end of each treatment period was combined for the febuxostat and the placebo arms.|At the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.|||percentage of participants|||Number
2639550|NCT01763996|Secondary|Change in Maximum ST-segment Depression During Exercise Treadmill Test|Continuous ECG was performed during an exercise treadmill test (modified Bruce protocol) to assess the maximum ST-segment depression after 6 weeks of febuxostat or placebo treatment in participants with a normal ST segment at randomization. A negative change from Baseline indicates improvement. Data at the end of each treatment period was combined for the febuxostat and the placebo arms.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with ST segment change.|||mm||Standard Deviation|Mean
2639551|NCT01763996|Secondary|Change in Time to Onset of ≥1 mm ST-Segment Depression During Exercise Treadmill Test (ETT)|Time in seconds to ischemic ECG changes during ETT. Continuous electrocardiography (ECG) was performed during an exercise treadmill test (modified Bruce protocol) to assess the onset of ST-segment depression after administration of febuxostat or placebo for 6 weeks in participants with a normal ST segment at randomization. . Data at the end of each treatment period was combined for the febuxostat and the placebo arms.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with ischemic ECG changes.|||seconds||Standard Deviation|Mean
2639552|NCT01763996|Secondary|Change in Coronary Flow Velocity Following the Administration of Sublingual Nitroglycerin at the End of the Administration of Febuxostat and Placebo|Coronary flow velocity was measured by MRI before and following administration of nitroglycerin under the tongue. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, who used nitroglycerin.|||cm/second||95% Confidence Interval|Least Squares Mean
2639553|NCT01763996|Secondary|Change in Coronary Artery Cross Sectional Area Following the Administration of Sublingual Nitroglycerin at the End of the Administration of Febuxostat and Placebo|Coronary artery cross sectional area was measured by MRI before and following administration of nitroglycerin under the tongue. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, who used nitroglycerin.|||mm^2||95% Confidence Interval|Least Squares Mean
2639554|NCT01763996|Secondary|Change in Coronary Artery Flow Following the Administration of Sublingual Nitroglycerin at the End of the Administration of Febuxostat and Placebo|Coronary artery flow was measured by MRI before and following administration of nitroglycerin under the tongue. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, who used nitroglycerin.|||mL/min||95% Confidence Interval|Least Squares Mean
2639555|NCT01763996|Secondary|Change in Coronary Flow Velocity From Rest to IHG Exercise at the End of the Administration of Febuxostat and Placebo|Coronary flow velocity was measured by MRI at rest and during sustained isometric (static) handgrip exercise. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.|||cm/second||95% Confidence Interval|Least Squares Mean
2639556|NCT01763996|Secondary|Change in Coronary Artery Cross-Sectional Area From Rest to IHG Exercise at the End of the Administration of Febuxostat and Placebo|Coronary artery cross-sectional area was measured by MRI at rest and during sustained isometric (static) handgrip exercise. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.|||mm^2||95% Confidence Interval|Least Squares Mean
2639604|NCT01763866|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639557|NCT01763996|Primary|Change in Coronary Artery Flow From Rest to Isometric Handgrip (IHG) Exercise at the End of the Administration of Febuxostat and Placebo|Coronary artery flow was measured using magnetic resonance imaging (MRI) at rest and during sustained isometric (static) handgrip exercises. Data at the end of each treatment period was combined for the febuxostat and the placebo arms. A positive change from Baseline indicates improvement.|Baseline and at the end of each 6 week treatment period (Week 6 and Week 12)|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available.|||mL/min||95% Confidence Interval|Least Squares Mean
2639558|NCT01763931|Secondary|Number of Participants With Adverse Events With Digoxin Treatment|To assess safety and tolerability of two weeks of digoxin therapy in the pre-surgical setting graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 4.|2 weeks|"Adverse events with digoxin is not applicable to the group no drug administration prior to surgery"|||Participants|||Count of Participants
2639559|NCT01763931|Primary|Change in HIF-1α Protein Expression|To assess whether two weeks of daily oral digoxin therapy, as compared to no study drug, reduces the expression of Hypoxia-inducible factor (HIF)-1α protein, measured by immunohistochemistry (IHC), in surgically resected breast cancer tissue obtained from women undergoing lumpectomy or mastectomy for invasive breast cancer.|Baseline (biopsy prior to surgery) and at the end of 2 weeks digoxin treatment|Not enough tissue samples were collected to be analyzed and so no data was generated for this outcome measure.||||||
2639560|NCT01763918|Secondary|Percent Change From Baseline in VLDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639561|NCT01763918|Secondary|Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639562|NCT01763918|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639563|NCT01763918|Secondary|Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639564|NCT01763918|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639565|NCT01763918|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639566|NCT01763918|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639567|NCT01763918|Secondary|Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639568|NCT01763918|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639569|NCT01763918|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639570|NCT01763918|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639571|NCT01763918|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639572|NCT01763918|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639573|NCT01763918|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639574|NCT01763918|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639575|NCT01763918|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639576|NCT01763918|Secondary|Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12||Week 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2639577|NCT01763918|Secondary|Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)||Weeks 10 and 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2639578|NCT01763918|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
2639579|NCT01763918|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
2639580|NCT01763918|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639581|NCT01763918|Primary|Percent Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set. Least squares (LS) means are from a repeated measures linear effects model; missing values were not imputed.|||percent change||Standard Error|Least Squares Mean
2639582|NCT01763905|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set with available data (no imputation was performed).|||percent change||Standard Error|Least Squares Mean
2639583|NCT01763905|Secondary|Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639584|NCT01763905|Secondary|Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639585|NCT01763905|Secondary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639615|NCT01763866|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639616|NCT01763866|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639617|NCT01763866|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639618|NCT01763866|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639619|NCT01763866|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639620|NCT01763866|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639621|NCT01763866|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639622|NCT01763866|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
2639623|NCT01763866|Secondary|Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
2639624|NCT01763866|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639625|NCT01763866|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639626|NCT01763827|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Inter-Quartile Range|Median
2639627|NCT01763827|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Inter-Quartile Range|Median
2639628|NCT01763827|Secondary|Percent Change From Baseline in VLDL-C at Week 12||Baseline and Week 12|Ful analysis set|||percent change||Inter-Quartile Range|Median
2639629|NCT01763827|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Inter-Quartile Range|Median
2639630|NCT01763827|Secondary|Percent Change From Baseline in Triglycerides at Week 12||Baseline and Week 12|Full analysis set|||percent change||Inter-Quartile Range|Median
2639631|NCT01763827|Secondary|Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Inter-Quartile Range|Median
2639632|NCT01763827|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Inter-Quartile Range|Median
2639633|NCT01763827|Secondary|Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Inter-Quartile Range|Median
2639634|NCT01763827|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639635|NCT01763827|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639636|NCT01763827|Secondary|Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639637|NCT01763827|Secondary|Percent Change From Baseline in Total Cholesterol/High Density Lipoprotein-cholesterol Ratio at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639638|NCT01763827|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639639|NCT01763827|Secondary|Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639640|NCT01763827|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639641|NCT01763827|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639642|NCT01763827|Secondary|Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12||Week 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2639643|NCT01763827|Secondary|Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL||Weeks 10 and 12|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2639644|NCT01763827|Secondary|Change From Baseline in LDL-C at Week 12||Baseline and Week 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
2639645|NCT01763827|Secondary|Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
2639646|NCT01763827|Primary|Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12||Baseline and Weeks 10 and 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639647|NCT01763827|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline and Week 12|Full analysis set|||percent change||Standard Error|Least Squares Mean
2639890|NCT01760993|Secondary|Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639648|NCT01763788|Secondary|Phase 2: Number of Participants With Serum Anti-Necitumumab Antibody Assessment (Immunogenicity)|A participant was considered to have an anti-Necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point.|Baseline up to 30 Days Post Last Infusion (estimated up to 39 months)|All enrolled participants who received at least 1 dose of drug and had evaluable data for antibodies during study Phase 2.|||Participants|||Count of Participants
2639649|NCT01763788|Secondary|Phase 2: PK: Minimum Concentration (Ctrough) of Necitumumab|The minimum observed serum concentration (Ctrough) of Necitumumab was evaluated.|Predose Day 1 of Cycle 1, 2, 3, 4, and every 2 cycles after Cycle 5|All enrolled participants who had adequate data to calculate at least 1 PK parameter during study Phase 2.|||microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2639650|NCT01763788|Secondary|Phase 1b: PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Gemcitabine and Cisplatin|The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time.|Gemcitabine: C1D1: Predose, End-of-infusion and 0.5, 1, 2 h post-end-of-infusion; Cisplatin:C1D1: Predose, End-of-infusion and 3, 21, 93, 165 h post-end-of-infusion|All enrolled participants who had adequate data to calculate at least 1 PK parameter during study Phase 1b. In cohort 1 (cisplatin), zero participants were analyzed because no data was collected for the outcome measure.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2639651|NCT01763788|Secondary|Phase 1b: PK: Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Necitumumab|The AUC(0-infinity) is area under the serum concentration-time curve from time zero to infinite time.|Cycle 1 (C1) Day 1 (D1) and C3 D1: Predose, End-of-infusion and 1, 3, 6, 24, 96, 168 h post-end-of-infusion|All enrolled participants who had adequate data to calculate at least 1 PK parameter during study Phase 1b. In cohort 1 and 2 (cycle 3), zero participants were analyzed because no data was collected for the outcome measure.|||microgram*hour per milliliter (µg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2639652|NCT01763788|Secondary|Phase 1b: PK: Cmax of Gemcitabine and Cisplatin|The Cmax is observed maximum plasma concentration, taken directly from the plasma concentration-time profile.|Gemcitabine: Cycle 1(C1) Day1(D1): Predose, End-of-infusion and 0.5, 1, 2 h post-end-of-infusion; Cisplatin:C1 D1: Predose, End-of-infusion and 3, 21, 93, 165 h post-end-of-infusion|All enrolled participants who had adequate data to calculate at least 1 PK parameter during study Phase 1b.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2639653|NCT01763788|Secondary|Phase 1b: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab|The Cmax is observed maximum serum concentration, taken directly from the serum concentration-time profile.|Cycle 1 (C1) Day 1 (D1) and C3 D1: Predose, End-of-infusion and 1, 3, 6, 24, 96, 168 h post-end-of-infusion|All enrolled participants who had adequate data to calculate at least 1 PK parameter during study Phase 1b. In cohort 1 (cycle 3), zero participants were analyzed because no data was collected for the outcome measure.|||micrograms/milliliter (µg/ml)||Geometric Coefficient of Variation|Geometric Mean
2639654|NCT01763788|Secondary|Phase 2: Change From Baseline in Lung Cancer Symptom Scale (LCSS)|The LCSS is a validated and reliable instrument to assess lung cancer-specific symptoms and their impact on QOL.The LCSS total score was defined as the mean of the 9 items of the scale and the average symptom burden index (ASBI) is defined as the mean of 6 symptom-specific lung cancer questions. Each of the 9 symptom or summary items is assessed on a 100-mm visual analogue scale (VAS), with 0 representing no symptoms or better QOL.|Baseline, Cycle 4 (Cycle = 3 weeks)|All randomized participants who received at least one dose of study drug had evaluable baseline and post-baseline LCSS data. One Cycle = 3 weeks and it can be delayed up to 6 weeks.|||units on a scale||Standard Deviation|Mean
2639655|NCT01763788|Secondary|Phase 2: Change From Baseline in EuroQol 5-Dimensional 3 Level (EuroQol-5D-3L) Visual Analog Scale (VAS)|EQ-5D VAS allowed participants to rate their present health condition. Possible scores ranged from 0 (worst imaginable health state) to 100 (best imaginable health state). One Cycle = 3 weeks and it can be delayed up to 6 weeks.|Baseline, Cycle 4 (Cycle = 3 weeks)|All randomized participants who received at least one dose of study drug and had had evaluable baseline and post-baseline EQ-5D data during study Phase 2.|||units on a scale||Standard Deviation|Mean
2639656|NCT01763788|Secondary|Phase 2: Change From Baseline in EuroQol 5-Dimensional 3 Level (EuroQol-5D-3L) Index Score|EQ-5D measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. The index score was calculated from a set of item weights to derive a score on a theoretical scale of 0 to 1, with 1 representing the best health status and zero representing death based on item weights for the Japanese population. One Cycle = 3 weeks and it can be delayed up to 6 weeks.|Baseline, Cycle 4 (Cycle = 3 weeks)|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline EQ-5D data during study Phase 2.|||Score on a scale||Standard Deviation|Mean
2639657|NCT01763788|Secondary|Phase 2: Time to Treatment Failure (TTF)|TTF was time from the date of randomization until the date of the first observation of radiographically documented progressive disease (PD), death due to any cause, discontinuation of treatment for any reason, or initiation of new anticancer therapy. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Time to treatment failure was censored at the date of the last follow-up visit for participants who did not discontinue early, who were still alive, and who have not progressed.|From Date of Randomization to Measured Progressive Disease, Death Due to Any Cause, Discontinuation of Treatment or Initiation of New Anticancer Therapy (Up To 39 Months)|All randomized participants who received at least one dose of study drug during study Phase 2. Censored participants in the GC+N Arm = 1 and in the GC Arm = 0.|||Months||95% Confidence Interval|Median
2639670|NCT01763567|Other Pre-specified|Functionality of HGMS: Alerts and Alarms - % of Hyper False Alert|Definition of % of Hyper False Alert: within 30 minutes before or after the sensor alarmed at 250 mg/dL, there is no reference blood glucose value (i-STAT) that goes above 250mg/dL . The % of hyper false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hyper False Alert and % Hyper Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same.|Up to 72 hours||||percentage of all alerts|||Number
2673274|NCT01462877|Secondary|Change in Serum Apolipoprotein A1|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set|||percentage of apoA1 change||Standard Deviation|Mean
2639658|NCT01763788|Secondary|Phase 2: Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR])|ORR was the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of nontarget lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.|Baseline to Measured Progressive Disease (Up To 39 Months)|All randomized participants who received at least one dose of study drug during study Phase 2.|||percentage of participants||95% Confidence Interval|Number
2639659|NCT01763788|Secondary|Phase 1b: Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response or Partial Response (Objective Tumor Response Rate [ORR])|ORR was the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of nontarget lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.|Baseline to Measured Progressive Disease (Up To 39 Months)|All randomized participants who received at least one dose of study drug during study Phase 1b.|||percentage of participants||95% Confidence Interval|Number
2639660|NCT01763788|Secondary|Phase 2: Progression Free Survival (PFS)|PFS defined as time from date of randomization until first radiographic documentation of measured progressive disease(PD) defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. PD was at least 20% increase in sum of diameters of target lesions with reference being smallest sum on study and an absolute increase of at least 5 mm,or unequivocal progression of non-target lesions,or 1 or more new lesions.If participant does not have complete baseline disease assessment,PFS time censored at date of randomization,regardless of whether or not objectively determined disease progression or death observed for participant.If participant was not known to have died or have objective progression as of data inclusion cutoff date for analysis,the PFS time censored at last adequate tumor assessment date.The use of new anticancer therapy prior to occurrence of PD resulted in censoring at the date of last radiographic assessment prior to initiation of new therapy.|From Date of Randomization to Measured Progressive Disease or Death Due to Any Cause (Up To 39 Months)|All randomized participants who received at least one dose of study during study Phase 2. Censored participants in the GC+N Arm = 6 and in the GC Arm = 10.|||Months||95% Confidence Interval|Median
2639661|NCT01763788|Primary|Phase 2: Overall Survival (OS)|OS defined as the time from the date of randomization to the date of death due to any cause. Participants who are alive at the time of study completion or are lost to follow-up will be censored at the time they were last known to be alive.|From Date of Randomization until Death Due to Any Cause (Up To 39 Months)|All randomized participants who received at least one dose of study drug during study Phase 2. Censored participants in the GC+N Arm = 27 and in the GC Arm = 17.|||Months||95% Confidence Interval|Median
2639662|NCT01763788|Primary|Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was defined as any of the following events graded according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, when the event occurred within 21 days from Day 1 in Cycle 1 and was considered to be definitely or probably related to necitumumab and/or gemcitabine-cisplatin chemotherapy: Grade 4 neutropenia ≥ 7 days, Grade ≥ 3 febrile neutropenia except for transient febrile neutropenia (Grade 3 neutropenia with fever ≥ 38.5 degrees Celsius (°C) for ≤ 24 hours), Grade 3 thrombocytopenia requiring platelet substitution, Grade 4 thrombocytopenia, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, arthralgia, myalgia, asthenia, fatigue, diarrhea, constipation, anorexia), any toxicity leading to the omission of necitumumab on Day 8 or 15 (for participants for whom necitumumab was delayed from Days 8 to 15) during the Cycle 1.|Day 1 to Day 21 in Cycle 1 (Up To 21 days)|All enrolled participants who received at least one dose of study drug during study Phase 1b.|||Participants|||Count of Participants
2639663|NCT01763645|Secondary|Occurrence of Anti-bevacizumab Antibodies|Secondary outcome measure for immunogenicity assessment|Day 1 (before the drug administration), Day 15, 64 and 127||||percentage of patients|||Number
2639664|NCT01763645|Secondary|Progression Rate|secondary outcome measure for efficacy evaluation|Day 127||||percentage of patients||95% Confidence Interval|Number
2639665|NCT01763645|Secondary|Stabilization Rate|secondary outcome measure for efficacy evaluation|Day 127||||percentage of patients||95% Confidence Interval|Number
2639666|NCT01763645|Secondary|Partial Response Rate|secondary outcome measure for efficacy evaluation|Day 127||||percentage of patients||95% Confidence Interval|Number
2639667|NCT01763645|Secondary|Complete Response Rate|secondary outcome measure for efficacy evaluation|Day 127||||percentage of patients||95% Confidence Interval|Number
2639668|NCT01763645|Primary|Area Under the Curve After the First Test Drug Administration|primary outcome measure for pharmacokinetics (PK) substudy|up to Day 22, after the first bevacizumab administration (time points for blood samples: 0 h 1.5 h, 3 h, 4.5 h, 6 h, 24 h, 96 h, 168 h, 336 h and 504 h)|Patients who received one dose of study drug and after 504 hours after injection had missed <= 1 blood sample collection to analyze pharmacokinetics.|||(ng/ml)*hour||Inter-Quartile Range|Median
2639669|NCT01763645|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Day 127|The efficacy analysis included only those patients who received at least one dose of BCD-021 or Avastin®, and in whom it was possible to assess the response to therapy.|||percentage of participans||95% Confidence Interval|Number
2652093|NCT01656252|Secondary|Phase II- Platelet Transfusion Requirements|To determine the impact of eltrombopag on platelet transfusion requirements in the setting of consolidation chemotherapy.|62 months|||||||
2639671|NCT01763567|Other Pre-specified|Functionality of HGMS: Alerts and Alarms - % of Hypo False Alert|Definition of % of hypo false alert: within 30 minutes before or after the sensor alarmed at 70 mg/dL, there is no reference blood glucose value (i-STAT) that goes below 70 mg/dL. The % of hypo false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hypo False Alert and % Hypo Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same.|Up to 72 hours||||percentage of all alerts|||Number
2639672|NCT01763567|Other Pre-specified|Functionality of HGMS: Alerts and Alarms - % of Hyper Events Correctly Detected|The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes above 250 mg/dL setting levels. The % of hyper events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants.|72 hours||||percentage of total events|||Number
2639673|NCT01763567|Other Pre-specified|Functionality of HGMS: Alerts and Alarms - % of Hypo Events Correctly Detected|The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes below 70 mg/dL setting levels. The % of hypo events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants.|up to 72 hours||||percentage of total events|||Number
2639674|NCT01763567|Primary|Device Performance: Accuracy of HGMS|"Mean Absolute Relative Difference (MARD), calculated as the absolute difference of [(sensor glucose values - iSTAT glucose values) / iSTAT glucose values].~The portable i-STAT handheld makes patient-side testing easy:~Requires no special sample preparation or user calibration; maintenance is minimal~Weighs 18 ounces, making it portable~Patient-side testing is as easy as entering the operator and patient information into the handheld, inserting one of the several filled test cartridges, and then viewing test results:~The system prompts users step by step through the testing process~Operator and patient information can be entered via barcode scanner~Operator lockout prevents unauthorized users from performing or viewing test results~Test results are uploaded automatically when the i-STAT handheld is placed in a downloader"|up to 72 hours|To assess safety and device performance for the Hospital Glucose Managment system|||percent difference||Standard Deviation|Mean
2639675|NCT01763346|Other Pre-specified|Glycemia|HbA1C|24 months|participants completing 24 months of interventions|||percent of hemoglobin||Standard Error|Mean
2639676|NCT01763346|Other Pre-specified|Glycemia|fasting and 2-hour OGTT glucose levels|24 months|participants completing 24 months of interventions|||mmol/l||Standard Error|Mean
2639677|NCT01763346|Primary|Steady State Beta Cell Compensation|mean plasma C-peptide concentration during clamp steady state, adjusted for mean clamp insulin sensitivity|24 months|Participants completing 24-month hyperglycemic clamp|||(nmol/L) adjusted for M/I||95% Confidence Interval|Geometric Mean
2639678|NCT01763333|Secondary|f t1-t2 (SRD-Part)|Fraction of analyte eliminated in urine from the time point t1 (0h) to time point t2 (72h) (f t1-t2).|0-4, 4-8, 8-12, 12-24, 24-48, 48-72 hours|TS-SRD|||Percentage||Geometric Coefficient of Variation|Geometric Mean
2639679|NCT01763333|Secondary|t1/2 (Terminal Half-life of the Analyte in Plasma)|Terminal half-life of the analyte in plasma (t1/2).|−2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing|TS-SRD and TS-BA|||hours||Geometric Coefficient of Variation|Geometric Mean
2639680|NCT01763333|Secondary|AUC0− tz|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0− tz).|−2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing|TS-SRD, TS-BA, PPS-DP, PPS-BA-T1-R1, PPS-BA-T2-R2, PPS-BA-R2-R1 and PPS-BA-T2-T1|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2639681|NCT01763333|Secondary|AUC0-inf|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).|−2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing|TS-SRD, TS-BA, PPS-DP, PPS-BA-T1-R1, PPS-BA-T2-R2, PPS-BA-R2-R1 and PPS-BA-T2-T1|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2639682|NCT01763333|Secondary|Tmax (Time From Dosing to Maximum Measured Concentration)|Time from dosing to maximum measured concentration (tmax).|−2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing|The treated set-SRD Part (TS-SRD) included all 68 subjects from the TS who participated in the SRD Part. The treated set-BA Part (TS-BA) included all 12 subjects from the TS who participated in the BA Part.|||hours||Full Range|Median
2639683|NCT01763333|Secondary|Cmax|"Maximum measured concentration of the analyte in plasma (Cmax).~The treated set-SRD Part (TS-SRD) included all 68 subjects from the TS who participated in the SRD Part. The treated set-BA Part (TS-BA) included all 12 subjects from the TS who participated in the BA Part.~The per protocol set for the evaluation of relative bioavailability of T1 vs R1 (PPS-BA-T1-R1) included all subjects of the TS-BA who provided observations under the reference treatment (R1) or test treatment (T1) for at least one of the endpoints Cmax, AUC0-tz, or AUC0-inf,without experiencing emesis at or before two times median tmax and without important protocol violations (PVs) relevant to the statistical evaluation of pharmacokinetic (PK). The same definition applies for the analysis set PPS-BA-T2-R2, PPS-BA-R2-R1 and PPS-BA-T2-T1."|−2.0 hours (h) before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing|TS-SRD, TS-BA, PPS-DP, PPS-BA-T1-R1, PPS-BA-T2-R2, PPS-BA-R2-R1 and PPS-BA-T2-T1|||nanomoles Per Litre (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2639684|NCT01763333|Primary|Number of Subjects With Drug Related Adverse Events|Percentage of subjects with drug related adverse events.|From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.|The treated set (TS) included all subjects who were documented to have taken at least one dose of study medication.|||Percentage of participants|||Number
2639685|NCT01763203|Secondary|Medication Adherence - Antidepressant Medication|A continuous measure of adherence as percentage of doses taken over the prior 7-day time period will be collected at 12 months and calculated for antidepressant medication, using a previously published formula. This will also be collected at 3 Months, to track changes over the study period.|12 months|Only study participants taking antidepressant medication were included in this analysis|||percentage of doses||Standard Deviation|Mean
2639891|NCT01760993|Secondary|Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639686|NCT01763203|Secondary|Medication Adherence - Antithrombotic Medication|A continuous measure of adherence as percentage of doses taken over the prior 7-day time period will be collected at 12 months and calculated for antithrombotic medication, using a previously published formula. This will also be collected at 3 Months, to track changes over the study period.|12 months|This outcome was only assessed during follow-up, so participants with no follow-up data (ie only baseline data) were excluded from the analysis.|||percentage of doses||Standard Deviation|Mean
2639687|NCT01763203|Secondary|Medication Adherence - Cholesterol Medication|A continuous measure of adherence as percentage of doses taken over the prior 7-day time period will be collected at 12 months and calculated for cholesterol medication, using a previously published formula. This will also be collected at 3 Months, to track changes over the study period.|12 months|This outcome was only assessed during follow-up, so participants with no follow-up data (ie only baseline data) were excluded from the analysis.|||percentage of doses||Standard Deviation|Mean
2639688|NCT01763203|Secondary|Medication Adherence - Blood Pressure Medication|A continuous measure of adherence as percentage of doses taken over the prior 7-day time period will be collected at 12 months and calculated for blood pressure medication, using a previously published formula. This will also be collected at 3 months, to track changes over the study period.|12 Months|This outcome was only assessed during follow-up, so participants with no follow-up data (ie only baseline data) were excluded from the analysis.|||percentage of doses||Standard Deviation|Mean
2639689|NCT01763203|Secondary|Medication Adherence - Global|"A single item adapted from two questions published elsewhere will be administered at 12 months. The adapted item is In the past week, how much of the time were you able to take your medications exactly as your doctor or nurse told you to? Response choices are 'None of the time,' 'A little of the time,' A good bit of the time,' 'Most of the time,' or 'All of the time.' This item will also be collected at Baseline, 3 Months, and 8 Months, to track changes over the entire study period."|12 Months||||Participants|||Count of Participants
2639690|NCT01763203|Secondary|Vascular Events|The Questionnaire for Verifying Stroke Free Status (QVSFS) will be collected as part of the 12 month survey. It will also be collected at baseline and 3 months to track changes over the entire study period. This questionnaire will also be collected every 6 months for up to 24 months after the study is completed to check for vascular events. The scoring was dichotomous: at least one new event (stroke, transient ischemic attack, or heart attack) versus none over the 12-month follow-up period.|12 months|This outcome was only assessed during follow-up, so participants with no follow-up data (ie only baseline data) were excluded from the analysis.|||Participants|||Count of Participants
2639691|NCT01763203|Secondary|Patient Perception of Quality of Stroke Preventative Care|"An adaptation of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) will be collected as a part of the 12 month questionnaire. It will also be collected at baseline and 3 month to track changes over the entire study period. The CAHPS question was Did you receive from any of your medical care providers the help you needed to make changes in your habits or lifestyle that would improve your health or prevent illness? Response choices are: 'Yes definitely' Yes somewhat' or 'No definitely not'."|12 months||||Participants|||Count of Participants
2639692|NCT01763203|Secondary|Knowledge About Stroke Risk Factors|"An adaptation of an existing instrument will be collected as a part of the 12 month survey. An open-ended question about what the participant believes is a stroke risk factor (I would like to ask you about stroke risk factors, those are the things that make it more likely for somebody to have a stroke. From anything you might have heard or read, what do you believe are the risk factors associated with stroke? What else...what else?, will be asked, then converted to three dichotomous variables: correct about at least 3 stroke risk factors versus less than three; correct about at least one stroke risk factor versus none correct; and reports that blood pressure is a stroke risk factor versus does not. This question will also be collected at baseline, 3 months, and 8 months to track changes over the entire study period."|12 months||||Participants|||Count of Participants
2639693|NCT01763203|Secondary|Knowledge About Stroke Signs|"An open-ended question about what the participant believes is a sign of a stroke (What are the warning signs of a stroke? What else...what else?), will be asked as a part of the 12 month survey. This question will also be collected at 3 months to track changes over the follow-up study period. Correct responses are numbness, weakness, difficulty speaking/understanding, vision disturbance, dizziness, and headache. Responses are scored as 0 correct, 1 correct, 2 correct, and 3 or more correct."|12 months||||Participants|||Count of Participants
2639694|NCT01763203|Secondary|Smoking|"A single question from the California Health Interview Survey 2011-2012 Adult Questionnaire will be collected as part of the 12-month outcome survey. The question asks whether over the interval since the previous study interview, were you smoking cigarettes every day, some days, or not at all? The question will also be collected at baseline (with a time frame of over the prior year) and at 3 months, to track changes over the entire study period. The scoring for this outcome is dichotomous: Smoking = a response of 'every day' or 'some days', versus Not smoking = a response of 'not at all.'"|12 months||||Participants|||Count of Participants
2639695|NCT01763203|Secondary|Fruit and Vegetable Intake|"Two questions from the California Health Interview Survey (CHIS) 2011-2012 will be collected as part of the 12-month outcome survey. The questions are During the past month, how many times did you eat fruit? Do not count juices and During the past month, how many times did you eat any other vegetables like green salad, green beans or potatoes? Do not include fried potatoes. For each question, the participant gives a number, and the frequency (per day, per week, or per month) is also recorded. Responses are converted to a number for day for each question, then summed across the two questions. The question is scored as a dichotomous variable of five or more servings of fruit and vegetables per day versus less than five servings of fruit and vegetables per day. The questions will also be collected at baseline and at 3 months, to track changes over the entire study period"|12 months||||Participants|||Count of Participants
2639709|NCT01763047|Primary|Binocular Near Visual Acuity (logMAR)|Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast, at 40cm under 250 cd/m^2. The test was presented under the condition High Luminance (250cd/m^2) High Contrast (90%).|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on each lens and strata.|||LogMAR||Standard Deviation|Mean
2673757|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|5 weeks (or after treatment session 10)|||||||
2639696|NCT01763203|Secondary|Soda Intake|"A single question from the California Health Interview Survey (CHIS) 2011-2012 will be collected as part of the 12-month outcome survey. The question is During the past month, how often did you drink regular soda or pop that contains sugar? The participant gives a number, and the frequency (per day, per week, or per month) is also recorded. The average daily servings of soda over the prior month is calculated, and the question is scored as a dichotomous variable of greater than or equal to 1 serving of soda per /day versus less than one serving of soda per day. The question will also be collected at baseline and at 3 months, to track changes over the entire study period"|12 months||||Participants|||Count of Participants
2639697|NCT01763203|Secondary|Salt Intake|"A single question, Are you currently watching or reducing your sodium or salt intake? from the Behavioral Risk Factor Surveillance System 2013, which has a dichotomous 'yes/no' response, will be collected as part of the 12 month outcome survey. The question will also be collected at baseline, 3 months, and at 8 months, to track changes over the entire study period"|12 months||||Participants|||Count of Participants
2639698|NCT01763203|Secondary|Physical Activity|The International Physical Activity Questionnaire (IPAQ) Short 7-Day version will be collected as part of the 12 month outcome survey. The questionnaire will also be collected at baseline and 3 months to track changes over the entire study period. The IPAQ score reflects energy expenditure of physical activity, and is reported in units of 'met minutes' which means metabolic equivalent. The minimum value is zero and there is no maximum. Higher scores mean better levels of physical activity.|12 months||||IPAQ met minutes||Standard Deviation|Mean
2639699|NCT01763203|Secondary|Waist Circumference|Waist circumference will be measured at 12-months according to the National Institutes of Health (NIH) guidelines. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period.|12 months||||cm||Standard Deviation|Mean
2639700|NCT01763203|Secondary|Body Mass Index|Body mass index will be measured at 12-months with a height and weight ratio. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period.|12 months||||kg/meter^2||Standard Deviation|Mean
2639701|NCT01763203|Secondary|Inflammation: C-reactive Protein|C-reactive protein will be measured at 12-months. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period.|12 months||||mg/L||Standard Deviation|Geometric Mean
2639702|NCT01763203|Secondary|Percentage of Glycated Hemoglobin (Hemoglobin A1C)|Hemoglobin A1C will be measured at 12-months. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period.|12 months||||percentage of glycated hemoglobin||Standard Deviation|Mean
2639703|NCT01763203|Secondary|Dyslipidemia|non-HDL cholesterol will be measured at 12-months. The same measurements will be taken at baseline and at the 3 month mark in order to track measurements throughout the entire participation period.|12 months||||mg/dL||Standard Deviation|Mean
2639704|NCT01763203|Primary|Systolic Blood Pressure|Blood pressure at 12 months will be the primary outcome. Blood pressure will also be measured at baseline and at the 3-month mark to track blood pressure during the entire participation period.|12 months||||mm Hg||Standard Deviation|Mean
2639705|NCT01763047|Primary|CLUE Overall Quality of Vision Using the Contact Lens User Experience (CLUE)TM Questionnaire|CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).|8-12 days post wear|The analysis consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on each lens and strata.|||units on a scale||Standard Deviation|Mean
2639706|NCT01763047|Primary|Percentage of Eyes With Bulbar Conjunctival Redness Grade 3 or Higher|Bulbar Conjunctival Injection was assessed in 4 regions (Nasal, Temporal, Inferior and Superior) using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3 for the maximum grade of all 4 regions.|8-12 days post wear|The Analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes for each lens and strata.|||Percentage of Subject Eyes|Subject Eyes||Number
2639707|NCT01763047|Primary|Percentage of Eyes With Limbal Conjunctival Redness Grade 3 or Higher|The Limbus refers to the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjuctival Redness was graded in 4 regions (Nasal, Temporal, Inferior and Superior) using the Efron Grading Scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4: Severe. The data was dichotomized into two group subjects with grade 3 or higher Limbal Conjuctival Redness, and those subjects with less than Grade 3 for the maximum grade of all 4 regions.|8-12 days post wear|The Analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes for each lens and strata.|||Percentage of Subject Eyes|Subject Eyes||Number
2639708|NCT01763047|Primary|Percentage of Eyes With Corneal Staining Grade 3 or Higher|Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher and those subjects with less than Grade 3 for the maximum grade of corneal staining across all 5 regions.|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation.The analysis was conducted on subject eyes for each lens and strata.|||Percentage of Subject Eyes|Subject Eyes||Number
2673758|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|2.5 weeks (or after treatment session 5)|||||||
2639710|NCT01763047|Primary|Binocular Distance Visual Acuity (LogMAR)|Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast, at 4m under 250 cd/m^2. The test was presented under the condition High luminance (250 cd/m^2) High Contrast (90%)|8-12 days post wear|The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on each lens and strata.|||LogMAR||Standard Deviation|Mean
2639711|NCT01762982|Secondary|Skin Irritation Scores at 72 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 72 hours following first product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.|||Number of participants|||Number
2639712|NCT01762982|Secondary|Skin Irritation Scores at 48 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 48 hours following first product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.|||Number of participants|||Number
2639713|NCT01762982|Primary|Proportion of Participants With Skin Irritation Scores at 72 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 72 hours following first product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.|||Percentage of participants|||Number
2639714|NCT01762982|Primary|Proportion of Participants With Skin Irritation Scores at 48 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 48 hours following first product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.|||Percentage of participants|||Number
2639715|NCT01762982|Secondary|Skin Irritation Scores at 24 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 24 hours following product application|ITT population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment. Missing data was not imputed.|||Number of participants|||Number
2639716|NCT01762982|Primary|Proportion of Participants With Skin Irritation Scores at 24 Hours|Irritation potential of the treatments was assessed by proportion of the irritation scores by a trained dermatologist. Skin Irritation reaction was categorized as: 0=No visible reaction; 1= Weak Erythema (Redness); 2=Erythema, Infiltration, Papule; 3= Erythema, Edema, Papule, Blister; 4=Erythema, Edema, Extreme Blistering. For the product to be deemed as non-irritant to skin, requirements were proportion of score of 2 should not be more than 1 out of 15 participants and no cases of score of 3 or 4.|Baseline to 24 hours following product application|Intention to Treat (ITT) population: All randomized participants who received the study treatments at baseline and had at least one post baseline skin irritation scoring assessment.|||Percentage of participants|||Number
2639717|NCT01762943|Secondary|Change in Inventory of Depression and Anxiety Symptoms (IDAS) Dysphoria Score|"The IDAS Dysphoria Scale consists of 10 items and uses a 5-point Likert-type scale, ranging from 1 to 5 with 1 indicating not at all and 5 indicating extremely. As such, the range of possible scores is 10 to 50. The Dysphoria scale includes items assessing feelings of depression, inadequacy, psychomotor agitation, guilt, discouragement, anhedonia, poor concentration, difficulty with decision-making, psychomotor retardation, and worry. Higher scores indicate greater dysphoria."|Assessed at baseline and post-treatment|Of the 36 women who enrolled in the study, 6 (4 PPD, 2 controls) were withdrawn prior to the second fMRI session. For the purpose of this group x time analysis, their data have been excluded. All 30 subjects who completed the protocol were included in this analysis.|||units on a scale||Standard Deviation|Mean
2639728|NCT01762800|Secondary|Percentage of Participants Who Used Relief Medication (Salbutamol)|Each evening participants recorded the number of occasions in the last 24 hours when they used their salbutamol for symptomatic relief of COPD symptoms. The percentage of participants who used relief medication in the study are presented.|24 weeks|mITT population|||Percentage of participants|||Number
2639729|NCT01762800|Secondary|Change From Baseline in FEV1|FEV1 is defined as the volume of air forcefully expelled from the lungs in one second. Baseline was a value at Visit 2 (randomization). Change from Baseline was calculated as specific timepoint value minus Visit 2 value. FEV1 was assessed at Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).|Baseline (Visit 2) and up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.|||Liters||Standard Deviation|Mean
2639718|NCT01762943|Primary|Blood-oxygen-level-dependent (BOLD) Response During Functional Magnetic Resonance Imaging (fMRI) z Statistic|The primary outcome measure was functional magnetic resonance imaging (fMRI) data collected during a Monetary Incentive Delay (MID) Task. The BOLD response was examined within the nucleus accumbens, a brain region that responds to monetary rewards. The z statistic represents the maximum contrast between win versus non-win outcomes during the MID task in the nucleus accumbens, averaged across the participants in each group. The mean BOLD response ranged from z=1.7 to 2.3; higher z scores indicate greater activation of the nucleus accumbens during reward. Individual z scores were generated using the Oxford Centre for Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library (FSL), which is a library of brain imaging analysis tools for fMRI.|baseline and hormone withdrawal|Of the 36 women who enrolled in the study, 6 were withdrawn prior to the second fMRI session. For the purpose of this group x time analysis, their data have been excluded. In addition, one participant had significant motion artifact (>4mm) during one run of the MID, and as such, her data were excluded from the analyses.|||z score||Standard Deviation|Mean
2639719|NCT01762904|Secondary|Detect Presence of Allergy or Skin Reaction by the Antiseptic Application|"135 units of measurement to test two antiseptics and two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol, Deionized water redistilled and Scrub the skin without prior application of any substance was tested. We prepared four skin's areas of 25 cm2, two in each forearm. The solution remained on the skin for 60s, 3h and 24h.~Presence of allergy or any skin reaction at 24 hours after the antiseptic application."|24 hours||||participants||Inter-Quartile Range|Median
2639720|NCT01762904|Primary|Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab|"135 units of measurement to test two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. Deionized water redistilled (Control 2: Control with scrub) and Scrub the skin without prior application of any substance (Control1: Control without scrub) was tested. Were prepared two skin's areas of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."|24 hrs||||(CFU/cm2)||Inter-Quartile Range|Median
2639721|NCT01762904|Primary|Evaluate the Residual Effect of Triclosan 1% / Isopropyl Alcohol 70% Administered Topically.|"135 determinations to test 1% triclosan in 70% isopropyl alcohol.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 1% triclosan in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."|24 hours||||(CFU/cm2)||Inter-Quartile Range|Median
2639722|NCT01762904|Primary|Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically|"135 determinations to evaluate residual effect of 2% chlorhexidine in 70% isopropyl alcohol.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."|24 hours||||(CFU/cm2)||Inter-Quartile Range|Median
2639723|NCT01762800|Secondary|Number of Participants in Each Treatment Efficacy Grade Evaluated by Physician|Physician evaluated treatment efficacy by using the following grades: significantly improved (SII), moderately improved (MOI), mildly improved (MII), no change (NC), mildly worse (MIW), moderately worse (MOW), and significantly worse (SIW). Treatment efficacy was assessed at Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).|24 weeks|mITT population|||Participants|||Number
2639724|NCT01762800|Secondary|Number of Participants in Each Treatment Efficacy Grade Evaluated by Participants|Participants evaluated treatment efficacy by using the following grades: significantly improved (SII), moderately improved (MOI), mildly improved (MII), no change (NC), mildly worse (MIW), moderately worse (MOW), and significantly worse (SIW). Treatment efficacy was assessed at Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).|Up to 24 weeks|mITT population|||Participants|||Number
2639725|NCT01762800|Secondary|Percentage of Participants Who Dropped Out|The percentage of participants who were withdrawn from the study.|24 weeks|All Subjects population: all participants who were enrolled into the study and whose data obtained at screening (visit1) was not missing and demography data was available.|||Percentage of participants|||Number
2639726|NCT01762800|Secondary|Percentage of Participants Who Required Additional Treatment to TRIPLE Therapy|The percentage of participants who required additional treatment to TRIPLE therapy is defined as number of participants who took additional medicine or therapy in TRIPLE therapy divided by number of participants who switch to TRIPLE therapy multiplied by 100.|24 weeks|mITT population|||Percentage of participants||95% Confidence Interval|Number
2639727|NCT01762800|Secondary|Percentage of Participants Who Stepped Down From TRIPLE Therapy to Initial Randomized Treatment|The percentage of participants who stepped down from TRIPLE therapy to initial randomized treatment was calculated as number of participants who step-down from TRIPLE therapy divided by number of participants who switch to TRIPLE therapy and then multiplied by 100.|24 weeks|mITT population|||Percentage of participants||95% Confidence Interval|Number
2639893|NCT01760993|Primary|Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639730|NCT01762800|Secondary|Forced Expiratory Volume in One Second (FEV1)|FEV1 is defined as the volume of air forcefully expelled from the lungs in one second. At Screening (Visit 1) spirometric assessments were conducted before (Visit 1A) and 30 to 60 minutes after a bronchodilator challenge (400 µg of salbutamol) (Visit 1B). FEV1 during each visit are presented. FEV1 was assessed at Visit 1A (Screening), Visit 1B (Screening), Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24).|Up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.|||Liters||Standard Deviation|Mean
2639731|NCT01762800|Secondary|Change From Baseline in CAT Total Score|Participants were assessed for COPD symptoms by means of CAT at each Visit. This assessment was performed prior to the spirometry testing. A CAT total score of less than 10 represents best health status and greater than 15 represents worst health status. Baseline was the value at Visit 2 (randomization). Change from Baseline was calculated as specific timepoint value minus Visit 2 value. Scores were assessed at Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24). Scores range from 0 to 40, high value in score indicate worse outcome.|Baseline and up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.|||Scores on a scale||Standard Deviation|Mean
2639732|NCT01762800|Secondary|Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) Total Score|Participants were assessed for COPD symptoms by means of CAT at each Visit. This assessment was performed prior to the spirometry testing. A CAT total score of less than 10 represents best health status and greater than 15 represents worst health status. Scores were assessed at Visit 1 (Screening), Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 8), Visit 6 (Week 12), Visit 7 (Week 16), and Visit 8 (Week 24). Scores range from 0 to 40, high value in score indicate worse outcome.|24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.|||Scores on a scale||Standard Deviation|Mean
2639733|NCT01762800|Secondary|Comparison of Number of Exacerbations Between Two Detection Methods: EXACT and Physician Diagnosis|The comparison of number of exacerbation between two detection methods EXACT and physician diagnosis: number of exacerbations detected by EXACT and number of exacerbations judged by physician.|24 weeks|mITT population|||Number of exacerbations||Standard Deviation|Mean
2639734|NCT01762800|Secondary|E-RS Subscale Score|The E-RS total score is an 11-item patient questionnaire, which provides information specific to respiratory symptoms-severity of respiratory symptoms overall and severity of breathlessness, cough and sputum, and chest symptoms. The E-RS subscale scores for respiratory symptoms (RS)-breathlessness (RS-BRL), RS-cough and sputum (RS-CSP), and RS-chest symptoms (RS-CSY) are presented. Scores were assessed at Baseline, Week 1-4, Week 5-8, Week 9-12, Week 13-16, Week 17-20 and at Week 21-24. Daily EXACT total score is obtained as total score of 14 items from diary. Daily E-RS total score as 11 items and Daily E-RS subscale scores are subset of E-RS total score. Mean EXACT total score is mean value of daily EXACT total score within subject by every 4 weeks(Week1-4, Week5-8, Week9-12, Week13-16, Week17-20, Week21-24). Same calculation of mean values are applied to E-RS total and E-RS subscale scores. RS total scores range from 0 to 40, high value in score indicate worse outcome.|24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.|||Scores on a scale||Standard Deviation|Mean
2639735|NCT01762800|Secondary|EXACT Respiratory Symptoms (E-RS) Total Score|"The E-RS total score is an 11-item patient questionnaire, which provides information specific to respiratory symptoms-severity of respiratory symptoms overall and severity of breathlessness, cough and sputum, and chest symptoms. Scores were assessed at Baseline, Week 1-4, Week 5-8, Week 9-12, Week 13-16, Week 17-20 and at Week 21-24. Daily EXACT total score is obtained as total score of 14 items from diary. Daily E-RS total score as 11 items and Daily E-RS subscale scores are subset of E-RS total score.~Mean EXACT total score is mean value of daily EXACT total score within subject by every 4 weeks(Week1-4, Week5-8, Week9-12, Week13-16, Week17-20, Week21-24). Same calculation of mean values are applied to E-RS total and E-RS subscale scores. Scores range from 0-100, high value in score indicate worse outcome."|Baseline and up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.|||Scores on a scale||Standard Deviation|Mean
2639736|NCT01762800|Secondary|EXACT Total Score.|"EXACT is a 14-item patient questionnaire used as a measure of respiratory symptoms (reported as units on a 0 [best health status] to 100 [worst possible status] scale). Scores were assessed at Baseline, Week 1-4, Week 5-8, Week 9-12, Week 13-16, Week 17-20 and Week 21-24. Daily EXACT total score is obtained as total score of 14 items from diary. Daily E-RS total score as 11 items and Daily E-RS subscale scores are subset of E-RS total score.~Mean EXACT total score is mean value of daily EXACT total score within subject by every 4 weeks(Week1-4, Week5-8, Week9-12, Week13-16, Week17-20, Week21-24). Same calculation of mean values are applied to E-RS total and E-RS subscale scores."|Baseline and up to 24 weeks|mITT population. Only those participants available at the specified time points (represented by n=X, X, X, X in the category titles) were analyzed.|||Scores on a scale||Standard Deviation|Mean
2639737|NCT01762800|Secondary|Time to First Exacerbation by EXAcerbations of Chronic Pulmonary Disease Tool (EXACT)|The EXAcerbations of Chronic pulmonary disease Tool (EXACT) is a 14-item patient-reported outcome (PRO) daily diary used to quantify and measure exacerbations of chronic obstructive pulmonary disease (COPD). Reported as units on a 0 [best health status] to 100 [worst possible status] scale). The day of detection of first exacerbation in any participant in each arm by EXACT.|24 weeks||||Days|||Number
2639738|NCT01762800|Secondary|Time to First Exacerbation by Physician's Diagnosis|The day of detection of first exacerbation in any participant in each arm as diagnosed by physician. Exacerbation is defined primarily by physician's judgment. Date of randomisation will be start point and timing of exacerbation (first exacerbation if there are more than one) will be event. For subjects without exacerbation, last day of study or follow up period is regarded as censor.|24 weeks|mITT population|||Days|||Number
2639739|NCT01762800|Secondary|Time to First Switching to TRIPLE Therapy|The day of first switch to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) for the first switching participant in each arm.|24 weeks|mITT population|||Days|||Number
2652421|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in Non-HDL-C||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2639740|NCT01762800|Secondary|Continuation Percentage of Participants Managed by Randomized Treatment Plus TRIPLE Therapy|The randomized treatment could be switched to TRIPLE therapy in the case that chronic obstructive pulmonary disease (COPD) was not controlled by the randomized treatment. Participants on TRIPLE therapy received SAL/FLU 50/250 µg BID plus TIO 18 µg QD together. Continuation TRIPLE proportion is defined as [(number of subjects who switched to TRIPLE) - (number of subjects who stepped down)/ number of evaluable population]*100. Randomised treatment continuation proportion is calculated by a formula: (100 - switch proportion).|24 weeks|mITT population|||Percentage of participants||95% Confidence Interval|Number
2639741|NCT01762800|Secondary|Percentage of Participants Managed by TRIPLE Therapy|Percentage of participants managed by TRIPLE therapy was calculated as [(number of participants who switched to TRIPLE therapy) - (number of participants who stepped down)/ number of evaluable population]*100|24 weeks|mITT population|||Percentage of participants||95% Confidence Interval|Number
2639742|NCT01762800|Secondary|Percentage of Participants Who Switched to TRIPLE Therapy|Switched to TRIPLE therapy is defined as: 1. Date of switch: when SAL/FLU or TIO was administered additionally to randomised treatment. 2. Date of randomisation was a start point and timing of switching (first switch if there are more than once) to TRIPLE was event. For participants without switching, last day of study or follow up period was regarded as censored. Percentage of participants who switched to TRIPLE therapy was calculated as: number of participants who switched to TRIPLE therapy divided by number of evaluable population and then multiplied by 100.|24 weeks|mITT population|||Percentage of participants||95% Confidence Interval|Number
2639743|NCT01762800|Primary|Percentage of Participants Who Were Able to Remain on the Randomized Treatment|The randomized treatment could be switched to TRIPLE therapy in the case that chronic obstructive pulmonary disease (COPD) is not controlled by the randomized treatment. Participants on TRIPLE therapy received SAL/FLU 50/250 µg BID plus TIO 18 µg QD together. The percentage of participants who were able to remain on the randomized treatment was calculated by the following formula: 100 minus percentage of participants who switched over to TRIPLE therapy.|24 weeks|Modified Intent-to-Treat (mITT) population: randomized participants who received at least a single dose of the investigational product.|||Percentage of participants||95% Confidence Interval|Number
2639744|NCT01762761|Secondary|Pharmacodynamic Parameter-Maturation Rate of Platelet Precursors (KOUT)|The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment. The estimate of KOUT was fixed to 0.0253 /hr.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK/PD Population|||1/ hr|||Number
2639745|NCT01762761|Secondary|Pharmacodynamic Parameter- Production Rate of Platelet Precursors (KIN)|The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment. The estimate of KIN was fixed to 1.43x10^9/L.hr.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK/PD Population|||1 x 10^9/L.hr|||Number
2639746|NCT01762761|Secondary|Pharmacodynamic Parameter-Linear Proportionality Constant of Drug Effect (SLOP): the Proportional Increase of Platelet Production Rate With Each 1-μg/mL Increase in Eltrombopag Plasma Concentration|The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK/PD Population|||Milliliter/microgram||95% Confidence Interval|Geometric Mean
2639747|NCT01762761|Secondary|Percentage of Participants Estimated as Responders to Eltrombopag by the Pharmacokinetic/ Pharmacodynamic Model|Responders are participants whose SLOP estimates are larger than zero. The Pharmacokinetic/ Pharmacodynamic relationship between eltrombopag concentrations and the platelet response was described by a four-compartment life span model, representing one precursor production compartment, two transit/maturation compartments and one blood platelet compartment.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK/PD Population: all participants with evaluable dosing, actual sampling time, and platelet count data.|||Percentage of participants|||Number
2639748|NCT01762761|Secondary|Post-hoc Estimates of Maximum Observed Concentration (Cmax) for Eltrombopag After 50 mg Once Daily Dose of Eltrombopag|Cmax is defined as maximum observed concentration after 50 mg once daily dose of eltrombopag. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Post-hoc estimates of steady-state eltrombopag Cmax was determined based on the final PK model. Individual PK parameters were derived from the final PK model by an empirical Bayes estimation. Summary of steady-state Cmax of eltrombopag .is presented here.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population|||Nanogram/ Milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
2639749|NCT01762761|Secondary|Post-hoc Estimates of Plasma Eltrombopag Area Under the Concentration-time Curve Over a Dosing Interval (AUC[0-tau]) After 50 mg Once Daily Dose of Eltrombopag|AUC[0-tau] is defined as area under the concentration-time curve over a dosing interval (24 hr) of Eltrombopag atsteady-state after 50 mg once daily dose of eltrombopag. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Post-hoc estimates of steady-state eltrombopag was determined based on the final PK model. Individual PK parameters were derived from the final PK model by an empirical Bayes estimation. Summary of steady-state AUC(0-tau) of eltrombopag is presented here.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population|||Microgram* hour per milliliter(μg.hr/mL)||95% Confidence Interval|Geometric Mean
2639759|NCT01762761|Secondary|Change From Baseline in Systolic Blood Pressure|Systolic blood pressure was measured in the sitting position at Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6|Safety Population|||Millimeters of mercury (mm Hg)||Standard Deviation|Mean
2639892|NCT01760993|Primary|Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639750|NCT01762761|Secondary|Pharmacokinetic Assessments for Eltrombopag for Absorption Lag Time (ALAG)|Absorption lag time (ALAG) is defined as the time taken for a drug to appear in the systemic circulation following administration. PK assessments were made with one group of serial sampling [Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose] and one group of sparse assessment [Samples collected at pre-dose, between 2 to 4 hrs and 5 to 8 hrs post-dose]. Pre-dose samples were collected within 2 hrs prior to dosing, all other samples were collected within 10 min for samples collected between 1 and 6 hr and within 30 min for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameter is presented.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population|||Hour||95% Confidence Interval|Geometric Mean
2639751|NCT01762761|Secondary|Pharmacokinetic Assessments for Eltrombopag for Absorption Rate Constant (Ka)|Ka is defined as the absorption rate constant. PK assessments were made with one group of serial sampling [Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose] and one group of sparse assessment [Samples collected at pre-dose, between 2 to 4 hr and 5 to 8 hr post-dose]. Pre-dose samples were collected within 2 hrs prior to dosing, all other samples were collected within 10 min for samples collected between 1 and 6 hrs and within 30 mins for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameter is presented.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population|||Per hour (1/hr)||95% Confidence Interval|Geometric Mean
2639752|NCT01762761|Secondary|Pharmacokinetic Assessments for Eltrombopag for Apparent Clearance (CL/F), Apparent Inter-compartmental Clearance (Q/F)|CL/F is defined as the apparent oral clearance from plasma and Q/F is defined as apparent intercompartmental clearance. PK assessments were made with one group of serial sampling [Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose] and one group of sparse assessment [Samples collected at pre-dose, between 2 to 4 hr and 5 to 8 hr post-dose]. Pre-dose samples were collected within 2 hr prior to dosing, all other samples were collected within 10 min for samples collected between 1 and 6 hr and within 30 min for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameters are presented.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population|||Liters per hour(L/hr)||95% Confidence Interval|Geometric Mean
2639753|NCT01762761|Secondary|Pharmacokinetic (PK) Assessments for Eltrombopag for Apparent Volume of Distribution of Central Compartment (Vc/F), Apparent Volume of Distribution of Peripheral Compartment (Vp/F)|Vc/F is apparent volume of distribution of plasma (VDP) in central compartment and Vp/F is apparent VDP in peripheral compartment. PK assessments were made with one group of serial sampling [Samples collected at pre-dose and 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 24 hr post-dose] and one group of sparse assessment [Samples collected at pre-dose, between 2 to 4 hr and 5 to 8 hr post-dose]. Pre-dose samples were collected within 2 hr prior to dosing, all other samples were collected within 10 minutes(min) for samples collected between 1 and 6 hrs and within 30 mins for samples collected at 8 and 24 hr. PK analysis was conducted using a population approach with non-linear mixed effects modeling methods. Point estimates of population PK parameters are presented.|From the start of study until 24 hours post-dose of Week 2 Visit of Stage 2|PK Population: all participants with evaluable dosing, actual sampling time, and eltrombopag concentration data.|||Liters||95% Confidence Interval|Geometric Mean
2639754|NCT01762761|Secondary|Number of Participants With the Indicated Grading of Myelofibrosis Using Bone Marrow Biopsy at Screening|Bone marrow biopsy was performed at Screening and then obtained when clinically indicated. Whenever a peripheral blood smear confirmed the presence of immature or dysplastic cells, a bone marrow examination was performed. Myelofibrosis (MF) was graded from Grade MF-0 to MF-3 where MF-0=scattered linear reticulin with no intersections (cross-overs) corresponding to normal bone marrow; MF-1=loose network of reticulin with many intersections; especially in perivascular areas; MF-2=diffuse and dense increase in reticulin with extensive intersections, occasionally with only focal bundles of collagen and/or focal osteosclerosis; MF-3=diffuse and dense increase in reticulin with extensive intersections with coarse bundles of collagen, often associated with significant osteosclerosis.|Screening|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Number
2639755|NCT01762761|Secondary|Number of Participants With a Change From Baseline in Visual Acuity|Visual acuity is a measure of the spatial resolution of the visual processing system. Acuity is a measure of visual performance and is unrelated to the eyeglass prescription required to correct vision. Normal visual acuity is commonly referred to as 20/20 vision. Evaluation was done for oculus sinister (OS) for the left eye, oculus dexter (OD) for the right eye. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|Safety Population|||Participants|||Number
2639756|NCT01762761|Secondary|Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Finding at Baseline|Resting 12-lead ECG was obtained at Baseline. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. ECG was also obtained when there was clinical symptom that potentially related to cardiac dysfunction based on investigator's judgement.|Baseline|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Particpants|||Number
2639757|NCT01762761|Secondary|Change From Baseline in Pulse Rate|Pulse rate was measured at Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6|Safety Population|||Beats per minute||Standard Deviation|Mean
2639758|NCT01762761|Secondary|Change From Baseline in Diastolic Blood Pressure|Diastolic blood pressure was measured in sitting position at Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Day 1 assessment was considered as Baseline; if Day 1 was not available then the Screening assessment was considered as Baseline. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6|Safety Population|||mm Hg||Standard Deviation|Mean
2656162|NCT01618942|Primary|Pressure Pain Threshold (PPT)With 0.01 cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure||||kg/cm2||Standard Deviation|Mean
2639760|NCT01762761|Secondary|Number of Participants With the Maximum Toxicity Grade for the Indicated Hematology Parameters|Clinical hematology parameters hemoglobin, lymphocytes, platelet count, total neutrophils, white blood cell count evaluations were performed at Baseline, at all on-therapy visits, and at Week 1, Week 2, Week 3, and Week 4 visits during the follow-up period and were summarized according to the NCI CTCAE V4.0: Grade 0, none; Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant; Grade 4, life-threatening consequences; Grade 5, death related to AE. Day 1 assessment was considered as Baseline; if Day 1 was not available then Screening assessment is taken as Baseline. Maximum post-Baseline toxicity grade included any scheduled or unscheduled post-Baseline assessment.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Number
2639761|NCT01762761|Secondary|Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters|Clinical chemistry parameters aspartate amino transferase (AST), alanine amino transferase (ALT), gamma glutamyl transferase (GGT), total bilirubin, albumin, alkaline phosphatase, calcium, potassium, creatinine, glucose and sodium were evaluated at Baseline, at all on therapy visits, and at Week 1, Week 2, Week 3, and Week 4 visits during the follow-up period and were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (NCI CTCAE V4.0): Grade 0, none; Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant; Grade 4, life-threatening consequences; Grade 5, death related to AE. Day 1 assessment was considered as Baseline; if Day 1 was not available then Screening assessment is taken as Baseline. For creatinine, Baseline is defined as the average of Screening and Day 1 values if available and prior to first dose. Maximum post-Baseline toxicity grade included any scheduled or unscheduled post-Baseline assessment|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Number
2639762|NCT01762761|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product.A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, is a congenital anomaly/birth defect or is associated with protocol specified liver injury and impaired liver function or is any protocol specific AEs.|From the start of study treatment (Day 1) up to the end of Week 8 of Stage 1|Safety Population: all randomized participants who received at least one dose of the study treatment.|||Participants|||Number
2639763|NCT01762761|Secondary|Number of Participants That Reduced or Discontinued Baseline Concomitant ITP Medications During Stage 2 and Stage 3|The number of participants taking concomitant ITP medications on Day 1 of Stage 1 who had a decrease in the dose or frequency of ITP medication or stopped ITP medication at any point during Stage 2 or Stage 3 will be presented. The Baseline concomitant ITP medication for Stage 2 and Stage 3 is defined as ITP medications taken prior to the first dose of investigational product of Stage 1. This study is still ongoing and this endpoint can only be analyzed when the stage 2 and stage 3 complete.|From the start of Stage 2 to the end of Stage 3|ITT Population: was comprised of all rand. participants who received at least 1 dose of study medication & with at least 1 platelet count post-baseline (BL) in stages 2 & 3.|||Participants|||Number
2639764|NCT01762761|Secondary|Maximum Period of Time a Participant Had a Platelet Count Continuously >= 50 ×10^9/L|Maximum period of time a participant had a platelet count continously >=50 x 10^9/L was analyzed using the van Elteren stratified rank test with stratification factors including the use of ITP medication at Baseline (yes/no), splenectomy (yes/no) and Baseline platelet count <=15x10^9/L (yes/no). Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Stage 3|ITT Population: was comprised of all rand. participants who received at least 1 dose of study medication & with at least 1 platelet count post-baseline (BL) in stages 1, 2 & 3.|||Weeks||Inter-Quartile Range|Median
2639765|NCT01762761|Secondary|Total Duration of Time a Participant Had a Platelet Count >=50×10^9/L|Total duration of time a participant had platelet count >=50 x 10^9/L was analyzed using the van Elteren stratified rank test with stratification factors including the use of ITP medication at Baseline (yes/no), splenectomy (yes/no) and Baseline platelet count <=15x10^9/L (yes/no). Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Stage 3|ITT Population: was comprised of all rand. participants who received at least 1 dose of study medication & with at least 1 platelet count post-baseline (BL) in stages 1, 2 & 3.|||Weeks||Inter-Quartile Range|Median
2639766|NCT01762761|Secondary|Number of Participants With a Platelet Count >=50×10^9/L During at Least 75% of Their Platelet Count Assessments|The number of participants with a platelet count >=50×10^9/L during at least 75% of their platelet count assessments was analyzed up to the end of Week 6 of Stage 1. Logistic regression analysis was adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15x10^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Stage 3|ITT Population: was comprised of all rand. participants who received at least 1 dose of study medication & with at least 1 platelet count post-baseline (BL) in stages 1, 2 & 3.|||Participants|||Number
2639767|NCT01762761|Secondary|Number of Participants Who Required Protocol-defined Rescue Treatment During the First 6 Weeks of Stage 1, Whole Stages 2 & 3|Rescue treatment is defined as either a new ITP medication, an increase in dose of concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy. Logistic regression analysis was adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15x10^9/L (yes/no) and treatment.|From the start of study treatment (Day 1) up to the end of Stage 3|ITT Population: was comprised of all rand. participats who received at least 1 dose of study medication & with at least 1 platelet count post-baseline (BL) in stages 1, 2 & 3.|||Participants|||Number
2639787|NCT01762345|Other Pre-specified|Percentage of Responders for Pad Weight Gain||from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"|||percentage of subjects|||Number
2639768|NCT01762761|Secondary|Time to Response|Time to response is defined as time from the startin of treatment to the first time of achieving a platelet count >=50x10^9/L during the first 6 weeks of Stage 1. Time to response is summarized using Kaplan-Meier estimates and compared between treatment groups using a stratified log-rank test, stratifying for the use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15x10^9/L (yes/no). The pike estimator of the treatment hazard ratio is based on the stratified log-rank test. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population: was comprised of all randomized participants who received at least 1 dose of study medication & with at least 1 platelet count post-baseline in Stage 1. Only those participants with a response were analyzed.|||Weeks||95% Confidence Interval|Median
2639769|NCT01762761|Secondary|Number of Participants With Clinically Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss. The WHO Bleeding Scale grades were dichotomized into the following categories: no clinically significant bleeding = Grade 0 to 1; clinically significant bleeding = Grade 2 to 4. Generalized linear mixed model with a Logit canonical link function for repeated binary data, allowing for Baseline dichotomized WHO bleeding grade, use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment as fixed effects, and the participant was treated as a random effect.|From the start of study treatment (Day 1) up to the end of Stage 3|ITT Population: was comprised of all rand. participats who received at least 1 dose of study medication & with at least 1 platelet count post-baseline (BL) in stages 1, 2 & 3.|||Participants|||Number
2639770|NCT01762761|Secondary|Number of Participants With Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss. The WHO Bleeding Scale were dichotomized to indicate no bleeding vs bleeding, i.e. 0=grade 0 and 1=grades 1, 2, 3 or 4. Generalized linear mixed model was applied with a Logit canonical link function for repeated binary data, allowing for Baseline dichotomized WHO bleeding grade, use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment as fixed effects, and the participant was treated as a random effect. Bleeding incidences were recorded at Screening, Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6 for Stage 1, Baseline, Weeks 4, 8, 16, 20, 24 for Stage 2; Baseline, Weeks 25, 29, 73, 97, 121, 145, 169, 193, 217, 241, 265, 284 for Stage 3. Bleeding incidences at these time points are presented.|From the start of study treatment (Day 1) up to the end of Stage 3|ITT Population: was comprised of all rand. participats who received at least 1 dose of study medication & with at least 1 platelet count post-baseline (BL) in stages 1, 2 & 3.|||Participants|||Number
2639771|NCT01762761|Secondary|Number of Participants Achieving a Platelet Count >=30×10^9/L and at Least 2 Times the Baseline Platelet Count at Least Once During the 6 Weeks of Stage 1, the Whole Stage 2 and the Whole Stage 3|The number of participants achieving a platelet count >=30×10^9/L and at least 2 times the Baseline platelet count at least once during the first 6 weeks of Stage 1 were analyzed. The Baseline platelet count is defined as the platelet count taken on Day 1 of the study or within 48 hours prior to the first dose of investigational product. Logistic regression analysis was adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Stage 3|ITT Population: was comprised of all rand. participats who received at least 1 dose of study medication & with at least 1 platelet count post-baseline (BL) in stages 1, 2 & 3. 1 part. did not have a BL platelet count as platelet count not collected on Day 1 or within 48 hours prior to the 1st dose of investig. product; this part. was not evaluable|||Participants|||Number
2639772|NCT01762761|Secondary|Number of Participants Achieving a Platelet Count >=50×10^9/L at Least Once During the First 6 Weeks of Stage 1|The number of participants (responders) with platelet count >=50×10^9/L at least once during the first 6 weeks of Stage 1 were compared between treatments using a logistic regression model adjusted for use of ITP medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|ITT Population: all randomized participants who received at least one dose of study medication and with at least one platelet count post-Baseline in Stage 1.|||Participants|||Number
2639773|NCT01762761|Primary|Number of Participants (Responders) Achieving a Platelet Count >=50×10^9/L After the First 6 Weeks of Stage 1|The number of participants (responders) with platelet count >=50x10^9/L after 6 weeks of Stage 1 were compared between treatments using a logistic regression model adjusted for use of primary immune thrombocytopenia (ITP) medication at Baseline (yes/no), splenectomy (yes/no), Baseline platelet count <=15×10^9/L (yes/no) and treatment. Complete blood count including platelet count was done at Week 1, Week 2, Week 3, Week 4, Week 5 and Week 6. Primary Analysis Data Set: a participant who withdrawals from Stage 1 or is emergently unblinded was classified as a negative response from the time of withdrawal or unblinding date and for all subsequent visits. In the event of a participant dying, information for all subsequent assessments would be considered missing. All intermittent missing data (apart from withdrawals) will be treated as missing.|From the start of study treatment (Day 1) up to the end of Week 6 of Stage 1|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of study medication and with at least one platelet count post-Baseline in Stage 1.|||Participants|||Number
2639774|NCT01762722|Primary|Accuracy of Sensor|A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around this line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square or ARMS. The smaller the ARMS the closer the data points lie around the line of identity, representing a more accurate sensor.|Data collected from individual participants over 1 hour timeframe. Data from cohort of subjects collected over 6 month period.|Multiple data points from each individual were pooled and presented as group data.|||percentage saturation||Full Range|Mean
2639775|NCT01762631|Other Pre-specified|Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 8 oz Prepared Bottles Only|"A caregiver will be defined as an individual who is a parent, grandparent, sibling, aunt or uncle, or nanny or babysitter who has provided care to an infant within the last 12 months.~Gram weight by direct weighing comparing the caregivers and non-caregivers in infant formula provision (not simulated intake) in 8 oz prepared bottles only. Each participant prepared 3 sets of 8 oz bottles, and all bottles of the specified size were included in the analysis."|Measures will be performed twice about 5-10 days apart|Number of participants' data analyzed is broken down between those who identified as infant caregivers and those who identified as infant non-caregivers.|||grams||Standard Deviation|Mean
2639776|NCT01762631|Other Pre-specified|Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 6 oz Prepared Bottles Only|"A caregiver will be defined as an individual who is a parent, grandparent, sibling, aunt or uncle, or nanny or babysitter who has provided care to an infant within the last 12 months.~Gram weight by direct weighing comparing the caregivers and non-caregivers in infant formula provision (not simulated intake) in 6 oz prepared bottles only. Each participant prepared 3 sets of 6 oz bottles, and all bottles of the specified size were included in the analysis."|Measures will be performed twice about 5-10 days apart|Number of participants' data analyzed is broken down between those who identified as infant caregivers and those who identified as infant non-caregivers.|||grams||Standard Deviation|Mean
2639777|NCT01762631|Other Pre-specified|Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 4 oz Prepared Bottles Only|"A caregiver will be defined as an individual who is a parent, grandparent, sibling, aunt or uncle, or nanny or babysitter who has provided care to an infant within the last 12 months.~Gram weight by direct weighing comparing the caregivers and non-caregivers in infant formula provision (not simulated intake) in 4 oz prepared bottles only. Each participant prepared 3 sets of 4 oz bottles, and all bottles of the specified size were included in the analysis."|Measures will be performed twice about 5-10 days apart|Number of participants' data analyzed is broken down between those who identified as infant caregivers and those who identified as infant non-caregivers.|||grams||Standard Deviation|Mean
2639778|NCT01762631|Other Pre-specified|Gram Weight of Infant Formula Provision Between Participants Who Identified as Infant Caregivers and Infant Non-caregivers for 2 oz Prepared Bottles Only|"A caregiver will be defined as an individual who is a parent, grandparent, sibling, aunt or uncle, or nanny or babysitter who has provided care to an infant within the last 12 months.~Gram weight by direct weighing comparing the caregivers and non-caregivers in infant formula provision (not simulated intake) in 2 oz prepared bottles only. Each participant prepared 3 sets of 2 oz bottles, and all bottles of the specified size were included in the analysis."|Measures will be performed twice about 5-10 days apart|Number of participants' data analyzed is broken down between those who identified as infant caregivers and those who identified as infant non-caregivers.|||grams||Standard Deviation|Mean
2639779|NCT01762631|Secondary|Kilocalorie (Kcal) Difference Between Different Bottle Sizes|"Kilocalorie difference between the Remote Food Photography Method and direct weighing separately analyzed by the four different bottle sizes that were prepared (2 oz bottles only, 4 oz bottles only, 6 oz bottles only, and 8 oz bottles only). Each participant prepared 3 sets of 2 oz bottles, 3 sets of 4 oz bottles, 3 sets of 6 oz bottles, and 3 sets of 8 oz bottles and all bottles of the specified size were included in the analysis.~Kilocalorie difference is Remote Food Photography Method - Direct Weighing"|Measures will be performed twice about 5-10 days apart|Since Cohort 2 had a modified protocol where the step involving photographs and direct weights of bottles with powdered formula only was not completed, the kilocalories for all participants in Cohort 2 cannot be determined. Powder not water is the source of kilocalories in formula; we could not accurately determine kilocalories without this step.|||kilocalories||Standard Deviation|Mean
2639780|NCT01762631|Primary|Kilocalorie (Kcal) Difference Between Methods for All Prepared Bottles|"Kilocalorie (Kcal) Difference in prepared infant formula intake detected in a bottle between the Remote Food Photography Method (RFPM) and direct weighing~Kilocalorie difference between the Remote Food Photography Method and direct weighing with all bottles that were prepared included~Kilocalorie difference is Remote Food Photography Method - Direct Weighing"|Measures will be performed twice about 5-10 days apart|Since Cohort 2 had a modified protocol where the step involving photographs and direct weights of bottles with powdered formula only was not completed, the kilocalories for all participants in Cohort 2 cannot be determined. Powder not water is the source of kilocalories in formula; we could not accurately determine kilocalories without this step.|||kilocalories||Standard Deviation|Mean
2639781|NCT01762501|Secondary|Change in 24-hour Mean Diastolic Blood Pressure Level|Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)|Baseline and 8 weeks||||mmHg||Standard Deviation|Mean
2639782|NCT01762501|Secondary|Change in 24-hour Mean Systolic Blood Pressure Level|Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)|Baseline and 8 weeks||||mmHg||Standard Deviation|Mean
2639783|NCT01762501|Secondary|Change in Nocturnal Diastolic Blood Pressure Level|Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8)|Baseline and 8 weeks||||mmHg||Standard Deviation|Mean
2639784|NCT01762501|Secondary|Change in the Absolute Value in Difference With Targeted Value* (15 Percent) of Nocturnal Systolic Blood Pressure Fall**|"Change from the start of the run-in period (Week -1) at the end of the treatment period (Week 8) *The targeted value has been set as the median of the dipping rate, normal type of nocturnal blood pressure variation, rate of nocturnal blood pressure fall (10-20 percent)~** Rate of nocturnal blood pressure fall: calculated as (awake SBP-sleep SBP)/awake SBP"|Baseline and 8 weeks||||mmHg||95% Confidence Interval|Mean
2639785|NCT01762501|Primary|Change in Nocturnal Systolic Blood Pressure Level|"Change at the end of a treatment period (Week 8) from the beginning point of an observation period~*Nocturnal systolic blood pressure level: the mean value of systolic arterial pressure during night (during sleeping)"|Baseline and 8 weeks||||mmHg||Standard Deviation|Mean
2639786|NCT01762345|Other Pre-specified|Percentage of Responders for SUI Episodes||from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"|||percentage of subjects|||Number
2639788|NCT01762345|Secondary|Change in Quality of Life as Measured by Incontinence Impact Questionnaire (IIQ-7)|The IIQ-7 is based on 7 questions referring to areas which may have been influenced or changed by accidental urine loss and/or prolapse. These questions are assigned a value of, 0 = 'Not at all,' 1= 'Slightly,' 2 = 'Moderately,' or 3 'Greatly.' The IIQ-7 is scored by taking the average score of items and then multiplying the average by 33 1/3 to put scores on a scale from 0 to 100. A lower score is considered less impact to quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction in scores from baseline reflects improved quality of life.|baseline and end-of-treatment|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data at the end of treatment"|||units on a scale||Inter-Quartile Range|Median
2639789|NCT01762345|Secondary|Change in Stress Urinary Incontinence Episodes|Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the first 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"|||episodes/usage period||Inter-Quartile Range|Median
2639790|NCT01762345|Secondary|Change in Pad Weight Gain|Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the first 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 1"|||grams/usage period||Inter-Quartile Range|Median
2639791|NCT01762345|Primary|Change in Stress Urinary Incontinence Episodes|Change from baseline as measured as reduction (improvement) in stress urinary incontinence episodes. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"|||episodes/usage period||Inter-Quartile Range|Median
2639792|NCT01762345|Primary|Change in Pad Weight Gain|Change from baseline as measured as reduction (improvement) in pad weight gain. Positive values are indicative of efficacious outcome.|from the 14-day baseline period to the last 7 days of 14-day device usage period|"Intent-to-Treat (ITT) population. The Number of Participants Analyzed is the number subjects with available (non-missing) data in week 2"|||grams/usage period||Inter-Quartile Range|Median
2639793|NCT01762059|Other Pre-specified|Mean Blood Sugar as Measured by Continuous Glucose Monitor (CGM) Readings||Days 2-5||||mg/dL||Standard Deviation|Mean
2639794|NCT01762059|Other Pre-specified|Fraction of Time Spent Within Each of the Following Glucose Ranges: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl||Days 2-5||||percentage of time||Standard Deviation|Mean
2639795|NCT01762059|Other Pre-specified|Difference in the Percentage of Subjects With Mean CGMG <154mg/dl During the Closed-loop Period vs. the Usual Care Period||5 days||||percentage of subjects|||Number
2639796|NCT01762059|Other Pre-specified|Percentage of Subjects With Mean CGMG < 154mg/dl||5 days||||percentage of subjects|||Number
2639797|NCT01762059|Secondary|Difference of Outcome Measures on Day 1 vs. Remaining Days (Days 2-5) During the Closed-loop Period.||5 Days|Data were not collected||||||
2639798|NCT01762059|Secondary|Number of Hypoglycemic Episodes During Exercise.||5 days|Data were not collected||||||
2639799|NCT01762059|Secondary|Mean BG During Exercise.||5 days|Data were not collected||||||
2639800|NCT01762059|Secondary|Difference of Outcome Measures on Days 1-2 vs. on Remaining Days (Days 3-5) During the Closed-loop Period.||5 Days|Data were not collected||||||
2639801|NCT01762059|Secondary|Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All GlucoScout and HemoCue Measurements.|"Measurements adjusted for the frequency of measurement (i.e. modeled so that more frequent measurements at the time of hypoglycemia and exercise will not skew the mean):~< 70 mg/dl,70-120 mg/dl,70-180 mg/dl, >180 mg/dl, >250 mg/dl"|5 Days|Data were not collected||||||
2639802|NCT01762059|Secondary|Average BG During the Closed-loop Control Period as Determined From All GlucoScout Measurements Taken During the Nighttime Monitoring.|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.|5 days|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.|||mg/dl||Standard Deviation|Mean
2639803|NCT01762059|Secondary|Correlation Between Exercise Intensity and Likelihood of a Hypoglycemic Event||5 days|Data were not collected||||||
2639804|NCT01762059|Secondary|Nadir BG During Exercise.||5 days|Data were not collected||||||
2639805|NCT01762059|Secondary|Number of Hypoglycemic Events as Determined From GlucoScout and HemoCue Measurements.||5 days|Data were not collected||||||
2639806|NCT01762059|Secondary|Difference in the Percentage of Subjects With Mean BG < 154 mg/dl During the Closed-loop Period vs. the Usual Care Period.||5 days|Data were not collected||||||
2639807|NCT01762059|Secondary|Percentage of Subjects With Mean BG < 154 mg/dl.|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.|5 days|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.|||percentage of participants|||Number
2639808|NCT01762059|Secondary|Difference in the Percentage of the Above Subset of BG Values Between the Closed-loop Control and Usual Care Periods Less Than 70 mg/dl.||5 days|Data were not collected||||||
2639809|NCT01762059|Secondary|Difference in the Average BG Between the Closed-loop Control Period and the Usual Care Period.||5 days|Data were not collected||||||
2639810|NCT01762059|Secondary|Percentage of the Subset of BG Values Less Than 70 mg/dl as Determined From All All HemoCue Measurements Taken During the Daytime and Scheduled GlucoScout Measurements Taken During the Nighttime.||5 days|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.|||percentage of time||Standard Deviation|Mean
2639867|NCT01761084|Secondary|Number of Potentially Eligible Males||over recruitment period|Total people screened for inclusion|||Participants|||Count of Participants
2639868|NCT01761084|Secondary|Number of Individuals Screened and Eligible Per Collection Site.|Number of participants randomized out of all participants screened|over the course of the study (2.29 years)||||Participants|||Count of Participants
2639811|NCT01762059|Secondary|Average BG During the Closed-loop Control Period as Determined From All HemoCue Measurements Taken During the Daytime and All Scheduled GlucoScout Measurements During the Nighttime.|During usual care (open loop), blood sugars were not checked through GlucoScout or HemoCue (as per usual care fashion) and so were not compared to bionic pancreas (closed loop) arm|5 days|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.|||mg/dl||Standard Deviation|Mean
2639812|NCT01762059|Primary|Percentage of Time Blood Glucose Values Less Than 70 mg/dl (Co-primary Outcome)|"Percentage of time blood glucose values during the closed-loop control period less than 70 mg/dl determined from HemoCue capillary measurements (daytime) and GlucoScout venous measurements (nighttime) during day 1-5.~During usual care (open loop), blood sugars were not checked through GlucoScout or HemoCue (as per usual care fashion) and so were not compared to bionic pancreas (closed loop) arm"|5 days|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.|||percentage of time||Standard Deviation|Mean
2639813|NCT01762059|Primary|Average Blood Glucose (Co-primary Outcome)|Average blood glucose during the closed-loop control period as determined from HemoCue capillary measurements (daytime+nightime) and GlucoScout venous measurements (nighttime).|5 days of closed-loop control|This outcome measure was only assessed for the closed loop control period, and was not assessed during the usual care arm.|||mg/dL||Standard Deviation|Mean
2639814|NCT01761747|Secondary|Define the Response Rate to Ponatinib is Patients With FGFR Amplifications Versus Mutations|Identify the response rate to ponatinib for FGFR specific FGFR amplifications/mutations.|2 years|There were no observed responses on study so this outcome could not be determined.||||||
2639815|NCT01761747|Secondary|Determine the Correlation FGFR Amplifications/Mutations With Patient Age, Sex, Disease Stage, Prior Response to Treatment and Smoking History|For subjects with FGFR amplifications and for FGFR mutations we will ascertain the age, sex, disease stage, prior response to treatment and smoking history from past medical records and measure whether there are differences in these variables among subjects with amplification versus mutation.|2 years|Too few subjects were enrolled on study to permit this outcome measure analysis.||||||
2639816|NCT01761747|Secondary|Disease Control|Measure the disease control rate of patients treated with ponatinib|2 years||||percentage of subjects|||Number
2639817|NCT01761747|Secondary|Overall Survival|Measure the overall survival time of patients treated with ponatinib|2 years||||days||Full Range|Mean
2639818|NCT01761747|Secondary|Define Toxicities of Ponatinib|Number of Participants with Adverse Events as a Measure of Safety and Tolerability|2 years||||participants|||Number
2639819|NCT01761747|Secondary|Progression-free Survival|Establish the progression-free survival of patients with SCC treated with ponatinib as defined by time to development of progression by RECIST criteria.|2 years||||days||Full Range|Mean
2639820|NCT01761747|Secondary|Prevalence of Specific FGFR Amplifications/Mutations in the Study Population|Test tumor DNA using molecular assays to measure the frequency of FGFR amplifications and mutations in study patients|2 years|2 participants had FGFR amplification, one with FGFR mutation|||participants|||Number
2639821|NCT01761747|Primary|Response Rate of Patients With Lung or Head and Neck SCC Treated With Ponatinib|"Investigate the response rate of patients with previously treated lung or head and neck SCC to ponatinib as defined by the proportion of subjects with investigator-assessed confirmed complete response (CR) or partial response (PR).~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|2 years||||percentage of subjects with response|||Number
2639822|NCT01761565|Primary|CST½|the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration|24|2 of the 40 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)|||hours||Full Range|Median
2639823|NCT01761565|Primary|Time to Steady State|Steady state, for the cohort, was assessed using Helmert's method (ratio of the geometric mean concentration of each time point to the geometric mean concentrations pooled over all remaining time points, and achieved at the first not-statistically significant time point (i.e., p >0.05)|24 hours|2 of the 40 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)|||hours|||Number
2639824|NCT01761565|Primary|Cmax|"For Treatment A, serial blood samples were taken at 0 (predose), 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, 800, and 840 minutes, and 24 hours after the Sufentanil NanoTab dose on Day 1.~For Treatment B, serial blood samples were collected at 0, 20, 120, 240, 360, 480, 600, 720, 760, 780, 785, 790, 795, 800, 810, 820, 830, 840, 850, 860, 870, 900, 960, 1020, 1140, 1260, 1380, 1500, 1580, and 1620 minutes, and 37 hours after the first Sufentanil NanoTab dose on Day 3"|24 hours in Treatment A, 37 hours in Treatment B|2 of the 40 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)|||pg/mL||Standard Deviation|Mean
2639825|NCT01761279|Other Pre-specified|Accuracy of Prediction of Polyp Surveillence Intervals|Accuracy of prediction of post-polypectomy surveillence colonoscopy intervasl based on national guidelines. Intervals based on in-vivo assessment of all polyps ≤5mm in size combined with histopathology of polyps >5mm in size will be compared to intervals determined by histopathology of all polyps|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|84 study participants in total. One patient excluded from this analysis as a single polyp was not retrieved for histological analysis.|||Percentage correct surveillence interval|||Number
2639826|NCT01761279|Secondary|Negative Predictive Value for Adenomatous Histology of Rectosigmoid Polyps ≤5mm in Size|Negative predictive value for adenomatous histology of rectosigmoid polyps ≤5mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. NPV compared to the gold standard of histopathology. Negative predictive value = number of true negatives/(number of true negatives + number of false negatives)|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|Numbers indicate the number of rectosigmoid polyps <5mm in size assessed as being non-neoplastic|||Percentage Negative Predictive Value|Participants|95% Confidence Interval|Number
2639869|NCT01761084|Secondary|Number of Serious Adverse Events.|Defined as death or event that is life-threatening, requires hospitalization or results in disability.|Monthly up to one year.||||events|||Number
2639827|NCT01761279|Secondary|Specificity for Adenomatous Histology of Colonic Polyps <10mm in Size|Specificity for adenomatous histology of in-vivo assessment of colonic polyps <10mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. Specificity compared to the gold standard of histopathology. Specificity for adenomatous histology = number of correctly identified non-neoplastic polyps (true negatives)/total number of non-neoplastic polyps (true negatives + false positives)|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|75 is the number of non-neoplastic polyps included in the study.|||Percentage specificity|Participants|95% Confidence Interval|Number
2639828|NCT01761279|Secondary|Sensitivity for Adenomatous Histology of Colonic Polyps <10mm in Size|Sensitivity for adenomatous histology of in-vivo assessment of colonic polyps <10mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. Sensitivity compared to the gold standard of histopathology. Senstivity for adenomatous histology = number of correctly identified adenomas (true positives)/total number of adenomas (true positives + false negatives)|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|134 is the number of adenomatous polyps included in the study.|||Percentage sensitivity|Participants|95% Confidence Interval|Number
2639829|NCT01761279|Primary|Diagnostic Accuracy of In-vivo Polyp Assessment|Diagnostic accuracy of in-vivo assessment of colonic polyps <10mm in size using high definition white light endoscopy and high definition white light endoscopy plus i-Scan image enhancement. Accuracy compared to the gold standard of histopathology. Accuracy - number of polyps with histology correctly predicted by in-vivo method/total number of polyps assessed (Expressed as a percentage)|Once histopathology results are known, approximately 2 weeks after in-vivo assessment|There were 84 patients included in the study. 209 polyps <10mm included in the study.|||% diagnostic accuracy|Participants|95% Confidence Interval|Number
2639830|NCT01761266|Other Pre-specified|Percent Change From Baseline in Serum Biomarker|The serum biomarkers analysed were angiopoietin-2 (ANG2), fibroblast growth factor 19 (FGF19), fibroblast growth factor 21 (FGF21), fibroblast growth factor 23 (FGF23) and vascular endothelial growth factor (VEGF) as blood serum biomarkers, and protein induced by vitamin K absence or antagonist-II (PIVKA-II) as a blood tumor marker in serum.|Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, Cycle 7 Day 1, Cycle 8 Day 1, Cycle 9 Day 1 and at the Off-Treatment Visit (approximately up to 3.8 years)|The pharmacodynamics (PD) analysis set included all participants who received at least 1 dose of study drug and had evaluable PD data. Here “n” was participants who were evaluable for the outcome measure at given time points.|||percent change||Standard Deviation|Median
2639831|NCT01761266|Other Pre-specified|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants with a best overall response of CR or PR or durable SD (duration of SD >=23 weeks after randomization). For participants whose best overall response (BOR) was SD, the duration of SD was defined as the time from the date of randomization to the first documented PD or death, whichever occurred first. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference the baseline sum of the diameters of target lesions. SD was when a case does not qualify for either PR or PD. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.|From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (approximately up to 3.8 years)|The FAS included all participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
2639832|NCT01761266|Other Pre-specified|Disease Control Rate (DCR)|DCR was defined as the percentage of participants with a best overall response of CR or PR, or stable disease (SD). Best overall response of SD must have been >=7 weeks after randomization. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference the baseline sum of the diameters of target lesions. SD was when a case does not qualify for either PR or PD and was new non-target lesions. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.|From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (approximately up to 3.8 years)|The FAS included all participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
2639833|NCT01761266|Secondary|Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib|AUC was assessed on Cycle 1 Day 1, Cycle 2 Day 2 and Cycle 1 Day 15. Summarized data for all time points was reported.|Cycle 1 Day 1, Cycle 1 Day 2: pre-dose, 0.5-4 and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 2-12 hours post-dose (cycle length= 28 days)|The pharmacokinetic (PK) analysis set included all participants who had received at least 1 dose of lenvatinib and had at least 1 quantifiable lenvatinib concentration.|||nanogram*hour per milliliter (ng*h/mL)||Standard Deviation|Mean
2639834|NCT01761266|Secondary|Time to Clinically Meaningful Worsening of HRQoL Assessed Using EuroQol Five Dimension Health Questionnaire (EQ-5D-3L)|"The EuroQol five dimension health questionnaire (EQ-5D-3L) was a health profile questionnaire that assessed quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 3-15 with 3 corresponding to no problems and 15 corresponding to severe problems in the 5 dimensions. EQ-5D-3L also included an EQ visual analogue scale (VAS) that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Decrease from baseline in EQ-5D-3L signifies improvement. Total index EQ-5D-3L summary score was weighted with a range of -0.594 (worst) to 1.0 (best). EQ-5D-3L also included an EQ health utilities index (HUI) where 1.00 indicated perfect health while a score of 0.00 indicated death."|Baseline up to Off-Treatment Visit (approximately up to 3.8 years)|The FAS included all participants who were randomized.|||months||95% Confidence Interval|Median
2639870|NCT01761084|Secondary|Physical Activity|A modified version of the Short-Form International Physical Activity Questionnaire (IPAQ) will be completed. A subset of participants at the University of Waterloo (St. Mary's General Hospital) will wear an accelerometer for 7 days.|Baseline, 6 months, 12 months|Withdrawals at 6 months – intervention group (n=4) and control group (n=5) Withdrawals at 12 months – intervention group (n=5) and control group (n=6)|||Minutes per week||Standard Deviation|Mean
2639835|NCT01761266|Secondary|Time to Clinically Meaningful Worsening of HRQoL Assessed Using - EORTC QLQ- Hepatocellular Carcinoma Domain (HCC 18)|"The EORTC QLQ-HCC-18 was an 18-item questionnaire design used along with the 30-item EORTC QLQ-C30. EORTC QLQ-HCC 18 questionnaire included 8 symptom scales such as fatigue, jaundice, body image, nutrition, pain, fever, sex life and abdominal swelling. Each individual item ranges from 1 to 4, where 1 = not at all and 4 = very much. All domain scores were calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represented a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represented a high QoL, but a high score for a symptom scale/item represented a high level of symptomatology/problem."|Baseline up to Off-Treatment Visit (approximately up to 3.8 years)|The FAS included all participants who were randomized.|||months||95% Confidence Interval|Median
2639836|NCT01761266|Secondary|Time to Clinically Meaningful Worsening of Health Related Quality of Life (HRQoL) Assessed Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)|The EORTC QLQ-C30 included 30 questions comprising 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social) and 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnoea, appetite loss, insomnia, constipation, diarrhea and financial difficulties) and a single global health and QOL status score. Most questions used a 4-point scale (1=Not at all to 4=Very much); 2 questions used a 7-point scale (1= Very poor to 7=Excellent). All domain scores were calculated as an average of item scores and transformed to 0 to 100 score range. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/quality of life (QoL) represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problem.|Baseline up to Off-Treatment Visit (approximately up to 3.8 years)|The FAS included all participants who were randomized.|||months||95% Confidence Interval|Median
2639837|NCT01761266|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on mRECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference to the baseline sum of the diameters of target lesions.|From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (approximately up to 3.8 years)|The FAS included all participants who were randomized.|||percentage of participants||95% Confidence Interval|Number
2639838|NCT01761266|Secondary|Time to Progression (TTP)|TTP was defined as the time from the date of randomization to the date of first documentation of disease progression based on mRECIST. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.|The time from the date of randomization to the date of first documentation of disease progression (approximately up to 3.8 years)|The FAS included all participants who were randomized.|||months||95% Confidence Interval|Median
2639839|NCT01761266|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first. Disease progression was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.|From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (approximately up to 3.8 years)|The FAS included all participants who were randomized.|||months||95% Confidence Interval|Median
2639840|NCT01761266|Primary|Overall Survival (OS)|OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.|From date of randomization until date of death from any cause (approximately up to 3.8 years)|The full analysis set (FAS) included all participants who were randomized.|||months||95% Confidence Interval|Median
2639841|NCT01761175|Secondary|Duration of Tourniquet|The total time the tourniquet was left inflated|The end of surgery||||minutes||Inter-Quartile Range|Median
2639842|NCT01761175|Secondary|Tourniquet Use|Number of participants who had a tourniquet during the surgery|The end of surgery|One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes.|||participants|||Number
2639843|NCT01761175|Secondary|Duration of Surgery||The end of surgery|One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes.|||minutes||Inter-Quartile Range|Median
2639844|NCT01761175|Secondary|Number of Patients With Postoperative Adverse Events Related to Nerve Block|Adverse events were defined by residual numbness, loss of sensitivity or weakness in the operated arm related to block performance or signs of hematoma or infection at the puncture site.|1 month after surgery|Eight patients in the infraclavicular group and five in the axillary group could not be contacted in the pre-established time frame.|||participants|||Number
2639845|NCT01761175|Secondary|Number of Patients With Postoperative Adverse Events Related to Nerve Block|Adverse events were defined by residual numbness, loss of sensitivity or weakness in the operated arm related to block performance or signs of hematoma or infection at the puncture site.|24 hours after surgery|Four patients in the infraclavicular group and six in the axillary group could not be contacted in the pre-established time frame.|||participants|||Number
2639846|NCT01761175|Secondary|Procedure-related Pain on a Visual Analog Pain Scale|Pain was evaluated by the patient on a visual analog pain scale ranging from 0 (no pain) to 10 (worst pain of their life).|After the nerve block procedure ended, up to 5 minutes.|One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success. This patient was not included in the other secondary outcomes. 3 other participants had missing data for this outcome.|||units on a scale||Inter-Quartile Range|Median
2639847|NCT01761175|Secondary|Performance Time of the Nerve Block|Performance time is defined as the sum of imaging time (defined as the time elapsed from the moment the Doppler probe is in contact with the patient to the insertion of the Tuohy needle) and needling time (from the insertion of the needle to its complete removal).|During the performance of the block|One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes.|||seconds||95% Confidence Interval|Mean
2639848|NCT01761175|Secondary|Surgical Block Success Rate|Surgical block success is defined by a nerve block allowing surgery without a rescue block, an infiltration of local anesthetics by the surgeon, administration of analgesics for pain in the surgical field or a general anesthesia.|End of surgery||||percentage of participants||95% Confidence Interval|Number
2639849|NCT01761175|Secondary|Time to Complete Motor Block|Complete motor block is defined by paralysis in the median, ulnar, radial and musculocutaneous nerves territories.|5, 10, 15, 20, 25 and 30 minutes after block completion|One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes.|||percentage of participants||95% Confidence Interval|Number
2639850|NCT01761175|Secondary|Time to Complete Sensory Block.|Complete sensory block is defined by anesthesia to cold sensation in the median, ulnar, radial and musculocutaneous nerves territories.|5, 10, 15, 20, 25 and 30 minutes after block completion|One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes.|||percentage of participants||95% Confidence Interval|Number
2639851|NCT01761175|Secondary|Number of Patients With Complete Motor Blocks|Complete motor block is defined by paralysis in the ulnar, radial, median and musculocutaneous nerves territories.|30 minutes after block completion||||percentage of participants||95% Confidence Interval|Number
2639852|NCT01761175|Primary|Number of Patients With Complete Sensory Block|Complete sensory block is defined by anesthesia to cold sensation in the ulnar, radial, median and musculocutaneous nerves territories.|30 minutes after block completion|Statistical analyses were conducted according to the intention-to-treat principle|||percentage of participants||90% Confidence Interval|Number
2639853|NCT01761162|Primary|Percentage of Participants Free of R-wave Sensing Attenuation|Evaluate the percentage of subjects free of R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.|Pre-MRI, 1 Month Post-MRI|Number of participants with a ventricular lead and same ventricular sensing polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.|||percentage of participants||95% Confidence Interval|Number
2639854|NCT01761162|Primary|Percentage of Participants Free of P-wave Sensing Attenuation|Evaluate the percentage of subjects free of P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.|Pre-MRI, 1 Month Post-MRI|Number of participants with an atrial lead and same atrial sensing polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.|||percentage of participants||95% Confidence Interval|Number
2639855|NCT01761162|Primary|Percentage of Participants Free of Ventricular Pacing Threshold Rise|Evaluate the percentage of ventricular pacing leads free of pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.|Pre-MRI, 1 Month Post-MRI|Number of participants with a ventricular lead and same ventricular threshold polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.|||percentage of participants||95% Confidence Interval|Number
2639856|NCT01761162|Primary|Percentage of Participants Free of Atrial Pacing Threshold Rise|Evaluate the percentage of atrial pacing leads free of pacing threshold increase between the pre-MRI and one-month post-MRI follow-up.|Pre-MRI, 1 Month Post-MRI|Number of participants with an atrial lead and same atrial threshold polarity (either uni- or bipolar) at pre-MRI and one-month post-MRI.|||percentage of participants||95% Confidence Interval|Number
2639857|NCT01761162|Primary|MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate||1 Month Post-MRI||||percentage of participants||95% Confidence Interval|Number
2639858|NCT01761084|Secondary|Participant Weight||Baseline and Month 12|Withdrawals at 12 months – intervention group (n=5) and control group (n=6). The remainder (7 intervention, 2 control) either did not attend the follow-up visit or did not have access to a scale at the visit.|||kilograms||Standard Deviation|Mean
2639859|NCT01761084|Secondary|Location of Vertebral Fractures|Any vertebral fracture (Genant Grade 1 or higher) found on x-ray, divided into location groupings of T1-T3, T4-T8, T9-L1, and L2-L5.|Baseline and Month 12|Withdrawals at 12 months – intervention group (n=5) and control group (n=6). The remainder (9 intervention, 8 control) did not have a second x-ray.|||Fractures|||Number
2639860|NCT01761084|Secondary|Timed Loaded Standing Test|A physical performance measure of combined trunk and arm endurance.|Baseline and one year|Only participants from the University of Waterloo and the University of Toronto sites assessed.|||Seconds||Standard Deviation|Median
2639861|NCT01761084|Secondary|Activities of Daily Living|0-10 scale about ability to do activities of daily living. Higher scores indicate more difficulty.|Monthly up to one year|Subsequent number of participants drops after baseline due to withdrawals or monthly follow-up not being completed.|||units on a scale||Standard Deviation|Mean
2639862|NCT01761084|Secondary|Participant Height||Baseline and one year|Withdrawals at 12 months – intervention group (n=5) and control group (n=6). The remainder (5 intervention, 2 control) did not attend the follow-up visit.|||centimetres||Standard Deviation|Mean
2639863|NCT01761084|Secondary|Value of Non-direct Medical Resources Per Participant.||Accrued costs over 12 months|For each resource cost, only participants utilizing the resource are included.|||Dollars (Canadian)||Standard Deviation|Mean
2639864|NCT01761084|Secondary|Value of Direct Medical Resources Per Participant.||Accrued costs over 12 months|For each resource cost, only participants utilizing the resource are included.|||Dollars (Canadian)||Standard Deviation|Mean
2639865|NCT01761084|Secondary|Total Number of Falls||Monthly up to 12 months.||||Falls|||Number
2639866|NCT01761084|Secondary|Number of Participants With Multiple Falls||Monthly up to 12 months.||||Participants|||Count of Participants
2639871|NCT01761084|Secondary|Productivity|Questionnaire regarding much did the participant's spine fracture(s) or osteoporosis affect their productivity while working? The scale is 0-10, with higher numbers indicating more effect on their work.|Monthly up to one year.|Only participants who reported working and/or volunteering were asked this question.|||units on a scale||Standard Deviation|Mean
2639872|NCT01761084|Secondary|Score on Short-form Falls Efficacy Scale International (FES-I).|Questionnaire about how concerned the participant is about the possibility of falling during common daily activities. Scores range from 7 (no concern about falling) to 28 (severe concern about falling.|Baseline, 6 months and one year.|Withdrawals at 6 months – intervention group (n=4) and control group (n=5). Withdrawals at 12 months – intervention group (n=5) and control group (n=6).|||score on a scale||Standard Deviation|Mean
2639873|NCT01761084|Secondary|Scores on Exercise Self-efficacy Scales.|"To assess self-efficacy related to engaging in exercise, participants will be asked Over the next 3 months, how confident are you that you can perform exercise on most days of the week? and Over the next 3 months, how confident are you that you can perform exercise on 3 days of the week?. To assess implementation intentions, participants are asked Do you already have concrete plans regarding exercise?. Patients will rate their answers on a scale from 1-5. Higher scores indicate greater exercise self-efficacy."|Baseline, 6 months and one year.|Withdrawals at 6 months – intervention group (n=4) and control group (n=5). Withdrawals at 12 months – intervention group (n=5) and control group (n=6)|||units on a scale||Standard Deviation|Mean
2639874|NCT01761084|Secondary|Quality of Life (QoL) and Pain Scores Measured Through the EuroQOL Instrument (EQ5D5L) and the Osteoporosis Quality of Life Questionnaire (OQLQ) and a Visual Analog Scale (VAS).|OQLQ scores range 1-7, with higher scores indicate greater quality of life. EQ5D5L VAS scores range 0-100, with higher scores indicating better overall health. VAS pain scores range 0-10, with lower scores indicating less pain.|Baseline, 6 months and one year.|Withdrawals at 6 months – intervention group (n=4) and control group (n=5). Withdrawals at 12 months – intervention group (n=5) and control group (n=6).|||score on a scale||Standard Deviation|Mean
2639875|NCT01761084|Secondary|Scores on Balance Outcome Measure for Elder Rehabilitation (BOOMER).|Balance Outcome Measure for Elder Rehabilitation (BOOMER) includes the step test, the Timed Up and Go, the Functional Reach test and the timed static stance feet together eyes closed test. The sub-scores of which are added to create a composite score (0-16), with higher scores indicating better performance.|Baseline and one year.||||score on a scale||Standard Deviation|Mean
2639876|NCT01761084|Secondary|Scores on the Short Physical Performance Battery (SPPB)|The SPPB consists of balance tests (side-by-side, semi-tandem, and tandem standing), gait speed during 4-meter walk test, and the average time taken to rise from a chair with arms folded across chest and sit back down (Five-Times-Sit-to-Stand test), sub-scores of which are added to determine a composite score (0-12), with higher scores indicative of better performance.|Baseline and one year.||||score on a scale||Standard Deviation|Mean
2639877|NCT01761084|Secondary|Occiput to Wall Distance||Baseline and one year.||||centimetres||Standard Deviation|Mean
2639878|NCT01761084|Secondary|Number of Fallers|Diary for participants to self-report falls.|Monthly up to one year.||||Participants|||Count of Participants
2639879|NCT01761084|Secondary|Number of Fractures.|Incident fracture will be a composite outcome of a vertebral fracture or fragility fracture (excluding fractures due to trauma or cancer). A fracture questionnaire will be used to ascertain the occurrence of fractures, the approximate timing and the cause with fracture occurrence, location and severity verified through health record data. Lateral thoracic and lumbar spine x-rays will be performed on participants at baseline (to confirm prevalent vertebral fractures) and follow-up (to identify new fractures). Vertebral fractures will be defined as radiographic presence of ≥25% reduction in anterior, middle or posterior height of a vertebra using the Genant visual semi-quantitative method.|Baseline, one year and at report of fracture (monitored monthly for reports).||||Fractures|||Number
2639880|NCT01761084|Primary|Adherence|Number of exercise sessions completed relative to prescribed. We will use a diary for participants to self-report adherence.|Monthly records over 12 months|Only the Exercise Group received the exercise program.|||% of weeks meeting adherence threshold||Full Range|Mean
2639881|NCT01761084|Primary|Feasibility of Recruitment and Retention|Number of participants recruited and retained. Criteria for success = 20 recruited per site and at least 75% retained.|Monthly records up to 12 months.||||Participants|||Count of Participants
2639882|NCT01761019|Secondary|Desire to Change to Another Systemic Therapy|We will measure the difference in percent of subjects who wish to change to another systemic therapy at baseline vs at week 12.|12 weeks||||Percentage of participants|||Number
2639883|NCT01761019|Secondary|Patient Satisfaction|"• Subject satisfaction: We also ask subjects for their level of satisfaction with their current treatment at week 12. They will be given the following options: very satisfied, satisfied, somewhat disappointed or very disappointed. For measurement very satisfied=4, satisfied=3, somewhat disappointed=2 and very disappointed=1. We will determine the mean satisfaction of all patients at week 12."|12 weeks||||units on a scale||Standard Deviation|Mean
2639884|NCT01761019|Secondary|Safety|Throughout this study, adverse events and serious adverse events will be collected|12 weeks||||adverse event|||Number
2639885|NCT01761019|Secondary|Body Surface Area|This is a measure of the percentage of the body involved with psoriasis. We will measure the change in percentage of body area involved with psoriasis from baseline to week 12.|12 weeks||||percentage of body surface area||Standard Deviation|Mean
2639886|NCT01761019|Primary|Investigator Global Assessment|This is score from 0-5 that measures, in the opinion of the study doctor, the severity of psoriasis on a subject, with 5 being most severe and 0 least severe. The change in this score between baseline and week 12 will be measured.|12 weeks||||units on a scale||Standard Deviation|Mean
2639887|NCT01760993|Secondary|Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639888|NCT01760993|Secondary|Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale||Up to 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639889|NCT01760993|Secondary|Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale||Baseline and week 52|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639894|NCT01760993|Primary|Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639895|NCT01760993|Primary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639896|NCT01760993|Primary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639897|NCT01760993|Primary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639898|NCT01760993|Primary|Columbia-Suicide Severity Rating Scale (C-SSRS)||Up to 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639899|NCT01760993|Primary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks||Baseline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639900|NCT01760993|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks||Basline and 52 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639901|NCT01760954|Secondary|Number of Days in Hospital During the Treatment Period|The Health Resource Use Questionnaire (HRUQ) was used to collect information on non-study-related health visits that participants had during the study, including physician visits, hospitalizations and types of procedures received.|6 months|Participants who received at least 1 dose of double-blind study drug in this extension study and who underwent hospitalization|||days||Full Range|Median
2639902|NCT01760954|Secondary|Number of Participants With Non-study Health Visits During the Treatment Period|The Health Resource Use Questionnaire (HRUQ) was used to collect information on non-study-related health visits that participants had during the study.|6 months|Participants who received at least 1 dose of double-blind study drug in this extension study|||Participants|||Count of Participants
2639903|NCT01760954|Secondary|Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household|"The HRPQ consists of 9 questions measuring the impact of endometriosis-associated pain and its treatment on work productivity and daily activities in the home.~Absenteeism: Number of hours of intended work lost due to illness or treatment. Presenteeism: Number of hours of work where output was impacted by illness or treatments.~Total hours lost is the sum of hours missed due to absenteeism plus presenteeism."|Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and month 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point. Hours lost from workplace were only calculated for participants who were employed.|||hours||Standard Deviation|Mean
2639904|NCT01760954|Secondary|Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension|"The EHP-30 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-30 consists of two parts: a core questionnaire containing 5 scales that are applicable to all women with endometriosis and a modular part containing 6 scales which do not necessarily apply to all women with endometriosis; only 1 modular questionnaire (sexual intercourse [5 items]) was used in this study.~The Sexual Intercourse dimension consists of 5 questions, each answered on the following scale: 0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Always, or Not Applicable (not scored). The dimension score ranges from 0 to 100, where 0 = best possible health status as measured by the questionnaire; 100 = worst possible health status. A negative change from baseline score indicates improvement in quality of life."|Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 3, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.|||units on a scale||Standard Deviation|Mean
2639905|NCT01760954|Secondary|Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension|"The EHP-30 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-30 consists of two parts: a core questionnaire containing 5 scales that are applicable to all women with endometriosis and includes pain, control and powerlessness, emotional well-being, social support, and self-image, and a modular part containing 6 scales which do not necessarily apply to all women with endometriosis.~Each question in the core questionnaire is scored on the following scale: 0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Always.~The pain dimension consists of 11 questions. The dimension score ranges from 0 to 100, where 0 = best possible health status as measured by the questionnaire; 100 = worst possible health status. A negative change from baseline score indicates improvement in quality of life."|Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 3, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.|||units on a scale||Standard Deviation|Mean
2639906|NCT01760954|Secondary|Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved|"The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:~Very Much Improved~Much Improved~Minimally Improved~Not Changed~Minimally Worse~Much Worse~Very Much Worse"|Months 1, 2, 3, 4, 5, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point.|||percentage of participants|||Number
2639919|NCT01760941|Other Pre-specified|Quantify the Percentage of Patients Receiving the Treatment Who Believe That the Treatment Was Worthwhile|Quantify the percentage of patients receiving the treatment who believe that the treatment was worthwhile|6 months|||||||
2639920|NCT01760941|Secondary|Evaluate the Treatment Influence on Patient Quality of Life|Evaluate the treatment influence on patient quality of life as measured by the ESAS.|2 weeks|||||||
2639907|NCT01760954|Secondary|Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS)|The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Participants were asked to assess their endometriosis pain over the past 24 hours at it's worst at approximately the same time every day in the e-Diary. Pain scores were averaged over the 35 days prior to each visit.|Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study and with available baseline data and data at each time point.|||percent change||Standard Deviation|Mean
2639908|NCT01760954|Secondary|Change From Baseline in Opioid Rescue Analgesic Use|Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, and/or codeine 30 mg + acetaminophen 300 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. Opioid rescue analgesic use was calculated as the total number of opioid pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day.|Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.|||pills/day||Standard Deviation|Mean
2639909|NCT01760954|Secondary|Change From Baseline in NSAID Rescue Analgesic Use|Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, and/or codeine 30 mg + acetaminophen 300 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. NSAID rescue analgesic use was calculated as the total number of NSAID pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day.|Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.|||pills/day||Standard Deviation|Mean
2639910|NCT01760954|Secondary|Change From Baseline in Any Rescue Analgesic Use|Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, and/or codeine 30 mg + acetaminophen 300 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. Any rescue analgesic use (NSAID and/or opioid) was calculated as the total number of pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day.|Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.|||pills/day||Standard Deviation|Mean
2639911|NCT01760954|Secondary|Percent Change From Baseline in Dyspareunia Based on Daily Assessment|"Participants assessed dyspareunia each day in an e-Diary according to the following response options:~0: None; No discomfort during sexual intercourse~1: Mild; Able to tolerate the discomfort during sexual intercourse~2: Moderate; Intercourse was interrupted due to pain~3: Severe; Avoided intercourse because of pain~Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.~Pain scores were averaged over the 35 days prior to each visit. Responses of Not Applicable were excluded."|Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study and with available baseline data and data at each time point; participants with responses of 'Not Applicable' on all reported days during baseline or for the entire time point were excluded from the analysis.|||percent change||Standard Deviation|Mean
2639912|NCT01760954|Secondary|Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment|"Participants assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options:~0: No discomfort~1: Mild discomfort but I was easily able to do the things I usually do~2: Moderate discomfort or pain that made it difficult to do some of the things I usually do~3: Severe pain that made it difficult to do the things I usually do.~Pain scores were averaged over the 35 days prior to each visit."|Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.|||percent change||Standard Deviation|Mean
2639913|NCT01760954|Secondary|Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment|"Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary according to the following response options:~0: No discomfort~1: Mild discomfort but I was easily able to do the things I usually do~2: Moderate discomfort or pain that made it difficult to do some of the things I usually do~3: Severe pain that made it difficult to do the things I usually do.~Pain scores were averaged over the 35 days prior to each visit."|Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.|||percent change||Standard Deviation|Mean
2639914|NCT01760954|Secondary|Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment|"Response was defined as a reduction of −0.36 or more from baseline in dyspareunia (pain during sexual intercourse) as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average rescue analgesic pill count and no additional analgesics).~Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed dyspareunia each day in an e-Diary. Dyspareunia was assessed according to the following:~0: None; No discomfort during sexual intercourse~1: Mild; Able to tolerate the discomfort during sexual intercourse~2: Moderate; Intercourse was interrupted due to pain~3: Severe; Avoided intercourse because of pain~Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.~Pain scores and analgesic use were averaged over the 35 days prior to each visit. Responses of Not Applicable were excluded."|Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6|"Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point; if a participant's mean score was not defined because all reports in that month were Not Applicable, then that mean score was treated as missing."|||percentage of participants|||Number
2639915|NCT01760954|Secondary|Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment|"Response was defined as a reduction of −0.36 or greater from baseline for non-menstrual pelvic pain as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average pill count of rescue analgesics and no additional analgesics). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665.~Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options:~0: No discomfort~1: Mild discomfort but I was easily able to do the things I usually do~2: Moderate discomfort or pain that made it difficult to do some of the things I usually do~3: Severe pain that made it difficult to do the things I usually do.~Pain scores and analgesic use were averaged over the 35 days prior to each visit."|Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5|Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point|||percentage of participants|||Number
2639916|NCT01760954|Secondary|Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment|"Response was defined as a reduction of -0.81 or more from baseline in dysmenorrhea as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average pill count of rescue analgesics and no additional analgesic). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665.~Participants recorded rescue analgesic medication for endometriosis-associated pain daily and dysmenorrhea (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. Dysmenorrhea was assessed according to the following:~0: No discomfort~1: Mild discomfort but I was easily able to do the things I usually do~2: Moderate discomfort or pain that made it difficult to do some of the things I usually do~3: Severe pain that made it difficult to do the things I usually do.~Analgesic use and pain scores were averaged over the 35 days prior to each visit."|Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5|Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point|||percentage of participants|||Number
2639917|NCT01760954|Primary|Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment|"Response was defined as a reduction of −0.36 or greater from baseline for non-menstrual pelvic pain as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average pill count of rescue analgesics and no additional analgesics). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665.~Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options:~0: No discomfort~1: Mild discomfort but I was easily able to do the things I usually do~2: Moderate discomfort or pain that made it difficult to do some of the things I usually do~3: Severe pain that made it difficult to do the things I usually do.~Pain scores and analgesic use were averaged over the 35 days prior to each visit."|Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and Month 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline and month 6 data.|||percentage of participants|||Number
2639918|NCT01760954|Primary|Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment|"Response was defined as a reduction of -0.81 or more from baseline in dysmenorrhea (pain during menstruation) as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average rescue analgesic pill count and no additional analgesic). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665.~Participants recorded rescue analgesic use for endometriosis-associated pain daily and dysmenorrhea and its impact on daily activities each day of their period in an electronic diary (e-Diary). Dysmenorrhea was assessed according to the following:~0: No discomfort~1: Mild discomfort but I was easily able to do the things I usually do~2: Moderate discomfort or pain that made it difficult to do some of the things I usually do~3: Severe pain that made it difficult to do the things I usually do.~Analgesic use and pain scores were averaged over the 35 days prior to each visit."|Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and Month 6|Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline and month 6 data.|||percentage of participants|||Number
2640227|NCT01756560|Primary|Analgesia Duration||72 hours|study terminated early due to lack of resources to recruit subjects and no data was collected for Outcome measures||||||
2639921|NCT01760941|Secondary|Evaluate the Treatment Influence on the Rate of Pain Stabilization and/or Reduction|Evaluate the treatment influence on the rate of pain stabilization and/or reduction as measured by the validated BPI patient questionnaire.|2 weeks|||||||
2639922|NCT01760941|Primary|Feasibility of Treatment Delivery in the Same Day as Initial Evaluation|Patient evaluation will consist of surveys conducted at the time of treatment measured by the Radiation Oncologist Evaluation and Feasibility Assessments survey|Up to 6 months|||||||
2639923|NCT01760889|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639924|NCT01760889|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)||Up to 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639925|NCT01760889|Secondary|Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639926|NCT01760889|Secondary|Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639927|NCT01760889|Secondary|Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale||Up to 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639928|NCT01760889|Secondary|Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale||Baseline and week 26|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639929|NCT01760889|Secondary|Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639930|NCT01760889|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639931|NCT01760889|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639932|NCT01760889|Secondary|Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639933|NCT01760889|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639934|NCT01760889|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639935|NCT01760889|Secondary|Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639936|NCT01760889|Primary|Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks||Baseline and 26 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2639937|NCT01760876|Secondary|OCT Endpoints (Neointimal Metrics), QCA Endpoints (Late Lumen Loss at 9 Months), and Clinical Endpoints (MACE at 9 Months and 12 Months). A Subgroup Analysis Would be Performed for Diabetic Patients.|Secondary endpoints would consist of OCT endpoints (neointimal area, neointimal thickness, neointimal volume, and percentage neointimal volume ), QCA endpoints (late lumen loss at 9 months), and clinical endpoints (MACE, including stent thrombosis up to 12 months). A subgroup analysis will be performed for DM patients.|9 months and 12 months||2017-12-31|12/2017||||
2639938|NCT01760876|Primary|OCT Findings on Coverage (Degree of Endothelialisation/Coverage) From 1 to 9 Months.|"The percentage of strut coverage and category of coverage (A to F) from 1 month to 9 months by longitudinal sequential OCT assessments.~A. Definitely uncovered - strut not covered by tissue, and both sides appear square; B. Uncovered with abnormal in-stent tissue - strut covered by irregular tissue or fibrin, and both sides appear square; C. Partially uncovered - strut partially covered by tissue but only one side has a smooth continuous shoulder; D. Covered (protruding) - strut covered by thin continuous tissue on both sides but still extending into the lumen; E. Covered (embedded) - strut covered by continuous tissue or neointima and not interrupting the smooth lumen contour; F. Covered (proliferative) - strut covered with excessive growth of neointima with thickness >0.3 mm."|1 to 9 months|100 patients treated with BF stents and randomly assigned to 5 monthly groups (n = 20:20:20:20:20) at 1 to 5 months receiving OCT follow-up, and then 100 patients altogether at 9 months for another follow-up.|||percentage of strut coverage (D+E+F)||Inter-Quartile Range|Median
2639939|NCT01760785|Secondary|Frequency of Alcohol Use|Frequencies of alcohol use/misuse will be measured weekly utilizing the Timeline Followback assessment. Participants will also be given an alcohol breath test at every clinic visit.|Weeks 1-10||||standard drinks/day||Standard Deviation|Mean
2639940|NCT01760785|Primary|Severity of Affective Lability Based on Shortened Agitated Behavior Scale|Severity of affective lability was measured using a shortened version of the Agitated Behavior Scale (ABS). The ABS is used to assess the nature and extent of present agitation. Eight items from the 14-item scale were used, which measured the presence and severity of various affective lability symptoms including: short attention span, impulsivity, uncooperative behavior, violent tendencies, restlessness, rapid or excessive talking, sudden changes in mood, and easily initiated or excessive crying and/or laughter. Each of the eight items was scored using a 1-4 Likert scale, where 1 stands for absence of symptom and 4 stands for presence to an extreme degree. The minimum possible score for this measure was 8, and the maximum possible score was 32. Due to the nature of the measure, a lower score indicated less severe affective lability, while conversely higher scores indicated more severe affective lability. The mean of scores for weeks 2 through 8 for each group were reported.|Weeks 2 through 8||||units on a scale||Standard Error|Mean
2639941|NCT01760733|Secondary|Associations Between Pre-transplant HRQoL/Comorbidity and Post Transplant Survival|Any associations between pre-transplant HRQoL/comorbidity and post transplant survival will be investigated using multivariable cox regression models.|From transplantation and up to ten years post tx||2022-12-31|12/2022||||
2639942|NCT01760733|Secondary|Associations Between Pre-transplant Patient and Transplant Characteristics and Intermediate Term (Three Years) Change in HRQoL|Demographic, medical and transplant characteristics were included in multivariable regression models to analyze any associations between these variables and any change in HRQoL described as KDQOL-SF scores between last score before transplantation and three years post transplantation|From last score before transplantation to three years post transplant||2021-06-30|06/2021||||
2639943|NCT01760733|Primary|Changes in Long Term (5-10 Years) Health Related Quality of Life, Measured by the KDQOL-SF Questionnaire|Longitudinally monitoring of health related quality of life (HRQOL) by the Kidney Disease and Quality of Life Short Form (KDQOL-SF) questionnaire from listing for transplantation and up to three years post transplantation. The KDQOL-SF scores are organized in 18 dimensions and the Scores for each Dimension are reported within the range 0-100, higher scores indicate better Health related quality of life. Scores obtained at baseline and every six months while patients were on the waiting list. In addition, scores are obtained at two, six, twelve months and at three years after transplantation. For this outcome, comparisons between last score obtained on the waiting list and the score at five and ten years post transplant are performed. The results are reported as absolute values and changes from baseline/last score before transplantation and the score at five and ten years post transplant.|From last score before transplantation to ten years post transplant||2025-12-31|12/2025||||
2639944|NCT01760733|Primary|Changes in Intermediate Term (Three Years) Health Related Quality of Life, Measured by the KDQOL-SF Questionnaire|Longitudinally monitoring of health related quality of life (HRQOL) by the Kidney Disease and Quality of Life Short Form (KDQOL-SF) questionnaire from listing for transplantation and up to three years post transplantation. The KDQOL-SF scores are organized in 18 dimensions and the Scores for each Dimension are reported within the range 0-100, higher scores indicate better Health related quality of life. Scores obtained at baseline and every six months while patients were on the waiting list. In addition scores are obtained at two, six, twelve months and at three years after transplantation. For this outcome, comparison between last score obtained on the waiting list and the score at three years post transplant is performed. The results are reported as absolute values and changes from baseline/last score before transplantation and the score at three years post transplant.|From baseline to three years post transplant||2020-12-31|12/2020||||
2639945|NCT01760733|Primary|Survival|Patient survival on the waiting list and after transplantation will be calculated and compared using the Kaplan Meier method and a Cox regression analysis with a time dependent variable.|From baseline/last score before transplantation to transplantation/up to ten years post transplant||2022-12-31|12/2022||||
2639946|NCT01760733|Primary|Health Economic Analyses|Quality Adjusted Life Years (QALY) are calculated based on Short Form-6D extracted from the SF-36 part of the KDQOL survey while patients were on the waiting list and after transplantation. QALYs are compared between the waiting list and up to three years after transplantation. Costs will be calculated based on information from the patients records and cost/QALY will be compared for the two periods|From baseline to three years post transplant||2021-06-30|06/2021||||
2639947|NCT01760733|Primary|Changes in Short-term (One Year) Health Related Quality of Life, Measured by the KDQOL-SF Questionnaire|Longitudinally monitoring of health related quality of life (HRQOL) by the Kidney Disease and Quality of Life Short Form (KDQOL-SF) questionnaire from listing for transplantation and up to one year post transplantation. The KDQOL-SF scores are organized in 18 dimensions and the Scores for each Dimension are reported within the range 0-100, higher scores indicate better Health related quality of life. Scores are obtained at baseline and every six months while patients were on the waiting list are performed. In addition scores are obtained obtained at two, six and twelve months after transplantation. Comparisons between last score obtained on the waiting list and score at twelve months after transplantation are performed. The results are reported as absolute values and changes from baseline/last score before transplantation and the scores at one year post transplant.|Change in health related quality of life from baseline to one year after transplantation|"Changes in SF-36 score for the dimension general health (GH) of the KDQOL-SF between baseline and one year after transplantation"|||score on a scale||Standard Deviation|Mean
2639948|NCT01760473|Secondary|SOWS|Subjective opioid withdrawal scale (SOWS) measure (0-64). Greater score indicates more severe withdrawal.|Throughout the testing sessions (approximately 9 weeks).||||units on a scale||Standard Error|Mean
2639949|NCT01760473|Primary|Drug Self-administration|The maximum number of responses (clicks on a computer mouse) the participant was willing to perform in order to receive a dose of the intranasal challenge drug under investigation.|Throughout the testing sessions (approximately 9 weeks).||||Clicks on a computer mouse||Standard Error|Mean
2639950|NCT01760304|Secondary|Evaluation of O2 Pulse|Evaluation of O2 Pulse is the measurement of oxygen consumption pre and post intervention|Change from Baseline and 45 minutes after administration of study medication or placebo||||ml/beat||95% Confidence Interval|Mean
2639951|NCT01760304|Secondary|Lung Hyperinflation|Evaluation of lung hyperinflation as determined by Pulmonary function test where Inspiratory Capacity (IC) before and 45 minutes after the administration of the budesonide/formoterol or placebo.|Change from Baseline and after 45 minutes after administration of study medication or placebo||||Liters||95% Confidence Interval|Mean
2639952|NCT01760304|Primary|Cardiac Output|"Impedance cardiography (ICG) (BioZ Dx ICG machine, by CardioDynamics) was used to measure cardiac output without the need for invasive devices. Cardiac output measurement by impedance cardiography (CO-ICG) is a plethysmography technique using sensors to detect the properties of the blood flow in the thorax.~All subjects had on each visit a baseline measurement at rest and then 45 minutes after intervention (Budesonide/formoterol or Placebo). Measurement were performed at rest for 5 minutes to obtain a steady state and the last 2 minutes were taken for analysis as an averaged value labeled as pre and post intervention. For the analysis we calculated the difference from pre and post intervention at each visit. Paired t-test was used to compare the mean+/- SD of the pre and post difference when taking the study drug vs placebo."|Change from Baseline and at 45 minutes after administration of study medication or placebo||||ml/beat||95% Confidence Interval|Mean
2656163|NCT01618942|Primary|Pressure Pain Threshold (PPT)With 0.1 cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure||||kg/cm2||Standard Deviation|Mean
2639953|NCT01760239|Primary|Participants With Appropriate Lifestyle Referral|Appropriate lifestyle referral is defined as referral to dietitian, weight loss, or exercise program within 6 months of meeting criteria for incident hypertension.|6 months|The sample was restricted to patients with BPs at >=3 visits with BP >=95th percentile, who were then passively monitored for study endpoints. Patients with a previous HT diagnosis were excluded.|||Participants|||Count of Participants
2639954|NCT01760239|Primary|Participants With Appropriate Workup for Secondary Causes of Hypertension|Appropriate workup for those with incident hypertension included an initiated workup for secondary causes of hypertension or end organ damage, defined as referral to cardiology, nephrology, or endocrinology, and/or orders for echocardiogram, ECG, or renal ultrasound.|6 months|The sample was restricted to patients with BPs at >=3 visits with BP >=95th percentile, who were then passively monitored for study endpoints. Patients with a previous HT diagnosis were excluded.|||Participants|||Count of Participants
2639955|NCT01760239|Primary|Participants With Clinical Recognition of Hypertension|Clinical recognition of hypertension as determined by one or more of the following; 1) hypertension or elevated BP as discharge diagnosis, 2) hypertension or elevated BP in the clinical note, 3) hypertension or elevated BP in discharge instructions, 4) hypertension or elevated BP added to the problem list.|6 months|The sample was restricted to patients with blood pressures at >=3 visits with blood pressure >=95th percentile, who were then passively monitored for study endpoints. Patients with a previous hypertension diagnosis were excluded.|||Participants|||Count of Participants
2639956|NCT01760187|Secondary|t1/2 for M3|Apparent terminal elimination half-life for M3 metabolite of lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27|All subjects with evaluable concentrations|||hr||Standard Deviation|Mean
2639957|NCT01760187|Secondary|AUC0-t for M3|Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for M3 metabolite of lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27|All subjects with evaluable concentrations|||ng*hr/mL||Standard Deviation|Mean
2639958|NCT01760187|Secondary|Tmax for M3|Time to maximum observed concentration for M3 metabolite of lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27|All subjects with evaluable concentrations|||hr||Full Range|Median
2639959|NCT01760187|Secondary|Cmax for M3|Maximum observed plasma concentration for M3 metabolite of lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27|All subjects with evaluable concentrations|||ng/mL||Standard Deviation|Mean
2639960|NCT01760187|Secondary|t1/2 for M1|Apparent terminal elimination half-life for M1 metabolite of lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27|All subjects with evaluable concentrations|||hr||Standard Deviation|Mean
2639961|NCT01760187|Secondary|AUC0-t for M1|Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for M1 metabolite of lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27|All subjects with evaluable concentrations|||ng*hr/mL||Standard Deviation|Mean
2639962|NCT01760187|Secondary|Tmax for M1|Time to maximum observed concentration for M1 metabolite of lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27|All subjects with evaluable concentrations|||hr||Full Range|Median
2639963|NCT01760187|Secondary|Cmax for M1|Maximum observed plasma concentration for M1 metabolite of lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27|All subjects with evaluable concentrations|||ng/mL||Standard Deviation|Mean
2639964|NCT01760187|Secondary|t1/2 for M3|Apparent terminal elimination half-life for M3 metabolite of lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7|All subjects with evaluable concentrations|||hr||Standard Deviation|Mean
2639965|NCT01760187|Secondary|AUC0-∞ for M3|Area under the plasma concentration versus time curve from zero to infinity for M3 metabolite of lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7|All subjects with evaluable concentrations|||ng*hr/mL||Standard Deviation|Mean
2639966|NCT01760187|Secondary|AUC0-t for M3|Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for M3 metabolite of lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7|All subjects with evaluable concentrations|||ng*hr/mL||Standard Deviation|Mean
2639967|NCT01760187|Secondary|Tmax for M3|Time to maximum observed concentration for M3 metabolite of lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7|All subjects with evaluable concentrations|||hr||Full Range|Median
2639968|NCT01760187|Secondary|Cmax for M3|Maximum observed plasma concentration for M3 metabolite of lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7|All subjects with evaluable concentrations|||ng/mL||Standard Deviation|Mean
2639969|NCT01760187|Secondary|t1/2 for M1|Apparent terminal elimination half-life for M1 metabolite of lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7|All subjects with evaluable concentrations|||hr||Standard Deviation|Mean
2639970|NCT01760187|Secondary|AUC0-∞ for M1|Area under the plasma concentration versus time curve from zero to infinity for M1 metabolite of lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7|All subjects with evaluable concentrations|||ng*hr/mL||Standard Deviation|Mean
2639971|NCT01760187|Secondary|AUC0-t for M1|Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for M1 metabolite of lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7|All subjects with evaluable concentrations|||ng*hr/mL||Standard Deviation|Mean
2639972|NCT01760187|Secondary|Tmax for M1|Time to maximum observed concentration for M1 metabolite of lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7|All subjects with evaluable concentrations|||hr||Full Range|Median
2639973|NCT01760187|Secondary|Cmax for M1|Maximum observed plasma concentration for M1 metabolite of lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7|All subjects with evaluable concentrations|||ng/mL||Standard Deviation|Mean
2639974|NCT01760187|Primary|t1/2 for Lomitapide|Apparent terminal elimination half-life for lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27|All subjects with evaluable concentrations|||hr||Standard Deviation|Mean
2639975|NCT01760187|Primary|AUC0-t for Lomitapide|Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27|All subjects with evaluable concentrations|||ng*hr/mL||Standard Deviation|Mean
2639976|NCT01760187|Primary|Tmax for Lomitapide|Time to maximum observed concentration for lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27|All subjects with evaluable concentrations|||hr||Full Range|Median
2639977|NCT01760187|Primary|Cmax for Lomitapide|Maximum observed plasma concentration for lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 27|All subjects with evaluable concentrations|||ng/mL||Standard Deviation|Mean
2639978|NCT01760187|Primary|t1/2 for Lomitapide|Apparent terminal elimination half-life for lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7|AUC0-∞ and t1/2 were not calculated for 3 subjects in the Japanese 10mg arm because the estimated t1/2 was being much longer than half of the total sampling time.|||hr||Standard Deviation|Mean
2639979|NCT01760187|Primary|AUC0-∞ for Lomitapide|Area under the plasma concentration versus time curve from zero to infinity for lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7|AUC0-∞ and t1/2 were not calculated for 3 subjects in the Japanese 10mg arm because the estimated t1/2 was being much longer than half of the total sampling time.|||ng*hr/mL||Standard Deviation|Mean
2639980|NCT01760187|Primary|AUC0-t for Lomitapide|Area under the plasma concentration versus time curve from hour 0 to the last measurable concentration for lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7|All subjects with evaluable concentrations|||ng*hr/mL||Standard Deviation|Mean
2639981|NCT01760187|Primary|Tmax for Lomitapide|Time to maximum observed concentration for lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7|All subjects with evaluable concentrations|||hr||Full Range|Median
2639982|NCT01760187|Primary|Cmax for Lomitapide|Maximum observed plasma concentration for lomitapide|1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on Day 7|All subjects with evaluable concentrations|||ng/mL||Standard Deviation|Mean
2639983|NCT01759862|Other Pre-specified|Presence of Fibrosis Measured on Protocol Biopsy|The investigators will use the same cores that are obtained during routine 6 months protocol biopsies to quantify the amount of fibrosis|6 months|Participants with available data were included in the analysis.|||Participants|||Count of Participants
2639984|NCT01759862|Secondary|Urinary NGAL (Neutrophil Gelatinase-associated Lipocalin)/ Creatinine Ratio|urinary NGAL(Neutrophil gelatinase-associated lipocalin) is a biomarker for kidney injury. NGAL levels 12h post-transplant were found to be a marker for development of delayed graft function and need for dialysis post-transplant. NGAL levels are corrected for urine creatinine.|12 hours post transplant|Participants with available data were included in the analysis.|||ng/mg||Inter-Quartile Range|Median
2639985|NCT01759862|Primary|Calculated Estimated Glomerular Filtration Rate (eGFR)|The investigators will measure blood creatinine on post-operative day 5 and using the Schwartz equation will calculate estimated glomerular filtration rate (GFR) to determine kidney function.|5 days|Intention to treat analysis|||ml/min/1.73m2||Standard Deviation|Mean
2639986|NCT01759602|Secondary|Expanded Disability Status Score (EDSS)|"The Kurtzke Expanded Disability Status Scale (EDSS) was developed to measure the disability status of patients with multiple sclerosis. It allows an objective quantification of the level of functioning that could be widely and reproducibly used by researchers and health care providers.~The EDSS provides a total score on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. In addition, it also provides eight subscale measurements called Functional System (FS) scores."|participants were followed for the duration of hospital stay ranging from 5-21 days, an average of 13 days; EDSS assessment was administered at discharge||||EDSS scores||Full Range|Median
2639987|NCT01759602|Secondary|Change From Baseline in Hematology, Chemistry, and Urinalysis Parameters.|"ALT elevations were considered mild if they rose to less than 4-fold baseline levels."|5-21 days||||participants|||Number
2639988|NCT01759602|Secondary|Percentage of Subjects Withdrawing Due to Adverse Events.||5-21 days||||percentage of subjects withdrawing|||Number
2639989|NCT01759602|Secondary|Frequency of Serious Adverse Events.||5-21 days||||serious adverse events|||Number
2639990|NCT01759602|Primary|Number of Adverse Safety Events During Hospitalization|Over the course of hospitalization for the acute NMO exacerbations, subjects will be monitored daily for frequency of adverse events.|5-21 days||||adverse safety events|||Number
2639991|NCT01759511|Secondary|Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120||Weeks 72 and 120|Participants in the Safety Analysis set with available data were analyzed.|||percent change in sLOXL2||Standard Error|Least Squares Mean
2639992|NCT01759511|Secondary|All-cause Mortality|All-cause mortality was assessed as a number of participants who died from any cause.|Up to 165 weeks|Safety Analysis Set|||Participants|||Count of Participants
2639993|NCT01759511|Secondary|Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144|"DLCO was a measurement to determine the extent to which oxygen passes from the air sacs of the lungs into the blood.~Least square means were from MMRM model including baseline DLCO % predicted and visit including all data up to Week 144."|Weeks 72 and 144|Participants in Safety Analysis Set with available data were analyzed.|||percent change in DLCO % predicted||Standard Error|Least Squares Mean
2639994|NCT01759511|Secondary|Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144|"FVC was a pulmonary function test, and was defined as the volume of air that can forcibly be blown out after taking a full breath.~Least square means were from mixed model for repeated measures (MMRM) model including baseline FVC % predicted and visit including all data up to Week 144."|Weeks 72 and 144|Participants in Safety Analysis Set with available data were analyzed.|||percent change in FVC % predicted||Standard Error|Least Squares Mean
2640228|NCT01756456|Other Pre-specified|Percentage of Patients That Achieved a ≥15 Letter Gain in BCDVA|Percentage of patients that achieved a ≥15 letter gain in best corrected distance visual acuity (BCDVA) at 4, 6, and 8 weeks|at 4, 6 and 8 weeks|ITT population|||percentage of subjects|||Number
2639995|NCT01759511|Primary|Overall Safety Profile of Simtuzumab|The overall safety of simtuzumab was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade 3 or 4 AEs, AEs related to simtuzumab, and AEs leading to discontinuation of simtuzumab), treatment-emergent chemistry and hematology abnormality.|30 days post last study treatment (up to 165 weeks)|Safety Analysis Set|||percentage of participants|||Number
2639996|NCT01759446|Primary|Emax - Maximum Drug Liking|"Do you dislike or like the drug effect you are feeling now? The question is scored using a 100-point bipolar visual analog scale (VAS) anchored in the center with neither like nor dislike (score of 50), on the left with Strong Disliking (score of 0) and on the right with Strong Liking (score of 100). Maximum Score. Assessment were made at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing."|8 hours|Completers of all doses per protocol|||score on a scale||Standard Deviation|Mean
2639997|NCT01759420|Secondary|Number of Adverse Events|The secondary objective is to determine the number of severe adverse cardiac electrical events (non-sinus rhythm, severe bradycardia, sudden cardiac death) associated with routine use of intravenous ondansetron in the adult emergency department patient. All of these outcomes will be recorded for each patient during the emergency department stay which could range from 20 minutes to several hours.|20 minutes to 8 hours||||percentage of patients||95% Confidence Interval|Number
2639998|NCT01759420|Primary|Change in QTc Interval With Ondansetron Administration|The primary objective is to determine the mean maximal prolongation in QTc interval from baseline as measured by the Bazett formula. A baseline EKG will be obtained and then after drug administration an EKG will be performed every 2 minutes until 20 minutes has passed. The mean maximal QTc change will be calculated.|Baseline to 20 minutes||||mS||95% Confidence Interval|Mean
2639999|NCT01759407|Secondary|Time to First Opioid Dose|Median time between PACU discharge and first opioid dose on the ward.|From PACU discharge until first opioid dose on the ward, assessed up to 24 hours||||hours||Inter-Quartile Range|Median
2640000|NCT01759407|Secondary|Intraoperative End-tidal Isoflurane %|Median end-tidal isoflurane concentration per participant during the average 1 1/2 hr. surgery.|1 1/2 hr.||||percentage of isoflurane||Inter-Quartile Range|Median
2640001|NCT01759407|Primary|Post-anesthesia Care Unit (PACU) Pain Scores|Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain.|30 mins after surgery||||pain score||Inter-Quartile Range|Median
2640002|NCT01759381|Primary|Number of Participants With Post-operative Infection (NPWT)|The patient will be assessed for signs/symptoms of infection within the 3 month post-operative period.|3 months||||participants|||Number
2640003|NCT01759368|Secondary|Utilization of Health Care Resources|Number of visits to nurse's reception|From baseline until the end of the study at six months||||number of visits||Standard Deviation|Mean
2640004|NCT01759368|Secondary|Left Ventricular Ejection Fraction|Change in left ventricular ejection fraction from baseline until the end of the study|From baseline until the end of the study at six months||||percentage unit||95% Confidence Interval|Mean
2640005|NCT01759368|Other Pre-specified|Plasma Concentrations of Creatinine, Natrium, and Potassium From the Baseline to the End of the Study|Change in plasma concentrations of creatinine, natrium, and potassium|From baseline to the end of the study at six months|||||||
2640006|NCT01759368|Secondary|EHFSBS (European Heart Failure Self-Care Behaviour Scale ) Scores|Change in self-care behaviour measured by the European Heart Failure Self-Care Behaviour Scale (EHFSBS). EHFSBS is a 12-item self-administered questionnaire specifically designed and tested for heart failure patients including statements on self-care behaviour essential in the care of HF. The statements are scored from one to five. The lower the score, the better the performance in self-care. The summary score is analysed.|From baseline until the end of the study at six months||||Scores on a scale||95% Confidence Interval|Mean
2640007|NCT01759368|Secondary|P-proBNP|Change in plasma concentration of brain natriuretic peptide propeptide from baseline to the end of the study.|From baseline until the end of the study at six months||||ng/l||Inter-Quartile Range|Median
2640008|NCT01759368|Secondary|Heart Transplant|Heart transplant operation or listing for transplant operation|From baseline until the end of the study at six months||||participants|||Number
2640009|NCT01759368|Secondary|Death|Death from any cause|From baseline until the end of the study at six months||||participants|||Number
2640010|NCT01759368|Primary|Number of HF-related Hospital Days|Number of heart failure related hospital days|From baseline until the end of the study at six months||||number of days||Standard Deviation|Mean
2640011|NCT01759290|Secondary|All Revascularization|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640012|NCT01759290|Secondary|Target Vessel Revascularization : Ischemic-driven (ID-TVR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640013|NCT01759290|Secondary|Target Vessel Revascularization (TVR): All TVR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640256|NCT01756352|Secondary|Overall Survival|The secondary objective is to assess the utility of FET-PET imaging for prediction of overall survival in recurrent glioblastoma.|From date of baseline PET scan until the date of death from any cause, assessed up to 2 years.||||days||Standard Deviation|Mean
2640014|NCT01759290|Secondary|Target Lesion Revascularization : Ischemia-Driven (ID-TLR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640015|NCT01759290|Secondary|Target Lesion Revascularization (TLR): All TLR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640016|NCT01759290|Secondary|All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640017|NCT01759290|Secondary|Death (Cardiovascular, Non-Cardiovascular)|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640018|NCT01759290|Secondary|All Revascularization|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640019|NCT01759290|Secondary|Target Vessel Revascularization : Ischemic-driven (ID-TVR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640020|NCT01759290|Secondary|Target Vessel Revascularization (TVR): All TVR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640021|NCT01759290|Secondary|Target Lesion Revascularization : Ischemia-Driven (ID-TLR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640022|NCT01759290|Secondary|Target Lesion Revascularization (TLR): All TLR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640023|NCT01759290|Secondary|All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640024|NCT01759290|Secondary|Death (Cardiovascular, Non-Cardiovascular)|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640025|NCT01759290|Secondary|All Revascularization|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640026|NCT01759290|Secondary|Target Vessel Revascularization : Ischemic-driven (ID-TVR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2656164|NCT01618942|Primary|Pressure Pain Tolerance (PTO) With 1cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure||||kg/cm2||Standard Deviation|Mean
2640027|NCT01759290|Secondary|Target Vessel Revascularization (TVR): All TVR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640028|NCT01759290|Secondary|Target Lesion Revascularization : Ischemia-Driven (ID-TLR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640029|NCT01759290|Secondary|Target Lesion Revascularization (TLR): All TLR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640030|NCT01759290|Secondary|All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640031|NCT01759290|Secondary|Death (Cardiovascular, Non-Cardiovascular)|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640032|NCT01759290|Secondary|All Revascularization|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640033|NCT01759290|Secondary|Target Vessel Revascularization : Ischemic-driven (ID-TVR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640034|NCT01759290|Secondary|Target Vessel Revascularization (TVR): All TVR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640035|NCT01759290|Secondary|Target Lesion Revascularization : Ischemia-Driven (ID-TLR)|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640036|NCT01759290|Secondary|Target Lesion Revascularization (TLR): All TLR|This is one of the Efficacy Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640037|NCT01759290|Secondary|All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV).|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640038|NCT01759290|Secondary|Death (Cardiovascular, Non-Cardiovascular)|This is one of the Safety Component (non-hierarchical) endpoints.|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640039|NCT01759290|Secondary|All Death/All MI||0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2656165|NCT01618942|Secondary|Measuring Values of Skinfold Thickness||10 minutes after the procedure||||millimeters||Standard Deviation|Mean
2640040|NCT01759290|Secondary|Cardiac Death/All MI||0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640041|NCT01759290|Secondary|Major Adverse Cardiac Event (MACE)|MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 407 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640042|NCT01759290|Secondary|Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)|Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640043|NCT01759290|Secondary|All Death, All MI, All Revascularization (DMR)||0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640044|NCT01759290|Secondary|All Death/All MI||0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640045|NCT01759290|Secondary|Cardiac Death/All MI||0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640046|NCT01759290|Secondary|Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))|Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 180 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640047|NCT01759290|Secondary|Major Adverse Cardiac Event (MACE)|MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 180 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640048|NCT01759290|Secondary|Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)|Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640049|NCT01759290|Secondary|All Death, All MI, All Revascularization (DMR)||0 to 180 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640050|NCT01759290|Secondary|All Death/All MI||0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640051|NCT01759290|Secondary|Cardiac Death/All MI||0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640052|NCT01759290|Secondary|Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))|Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 37 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640053|NCT01759290|Secondary|Major Adverse Cardiac Event (MACE)|MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 - 37 Days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640054|NCT01759290|Secondary|Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)|Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640055|NCT01759290|Secondary|All Death, All MI, All Revascularization (DMR)||0 to 37 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640056|NCT01759290|Secondary|All Death/All MI||0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640057|NCT01759290|Secondary|Cardiac Death/All MI||0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640058|NCT01759290|Secondary|Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))|Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640059|NCT01759290|Secondary|Major Adverse Cardiac Event (MACE)|MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640060|NCT01759290|Secondary|Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)|Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640061|NCT01759290|Secondary|All Death, All MI, All Revascularization (DMR)||0 to 7 days (In-hospital)|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640062|NCT01759290|Secondary|Late Scaffold Thrombosis||31 to 365 Days|Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.|||percentage of participants|||Number
2640063|NCT01759290|Secondary|Subacute ScaffoldThrombosis||1 to 30 days|Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.|||percentage of participants|||Number
2640064|NCT01759290|Secondary|Acute Scaffold Thrombosis||<1 day|Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Scaffold Thrombosis event.|||percentage of participants|||Number
2640065|NCT01759290|Secondary|Acute Success: Clinical Procedure Success (Per Subject Analysis)|Procedure success was defined as the achievement of a final in-scaffold diameter stenosis of <50% by online quantitative coronary angiography (QCA) or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non-Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure.|During the hospital stay with a maximum of 3 days post index procedure||||percentage of participants||95% Confidence Interval|Number
2640066|NCT01759290|Secondary|Acute Success: Clinical Device Success (Lesion Level Analysis)|Device success was defined as the achievement of a final in-scaffold residual diameter stenosis of <50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. A device was considered to have failed if it did not meet the requirements of the definition for clinical device success.|< or = 1 day||||percentage of lesions|Participants|95% Confidence Interval|Number
2640067|NCT01759290|Primary|Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))|Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).|0 to 407 days|Subjects are only counted once for each type of event in each time period.The denominators used in the calculations determined according to the analysis population with excluding subjects who are lost to follow-up through given timepoint without any DMR event (all death, all MI per Protocol definition, all revascularization, respectively).|||percentage of participants||95% Confidence Interval|Number
2640068|NCT01759277|Primary|Hours Until Discharge Readiness|Discharge readiness is the number of hours until meeting the following 4 criteria: (1) adequate analgesia (defined as pain less than 4 on a NRS of 0-10); (2) independence from intravenous analgesics; (3) ability to ambulate 30 m and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance.|7 postoperative days||||hours||Inter-Quartile Range|Median
2640069|NCT01759264|Secondary|Percentage of Participants With Clinical Response (CR) Due to Adalimumab Treatment|CR70 and CR100 was a decrease from baseline (Week 0) in CDAI score of 70 and 100 or more points, respectively, a lower score indicating improvement in disease activity.|At Week 4, 8, and 12|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).|||Percentage of participants|||Number
2640070|NCT01759264|Secondary|Percentage of Participants With Remission of Crohn's Disease|Crohn's Disease Activity Index (CDAI) was a composite index consisting of a weighted scoring of eight disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600, a higher score indicates increased disease severity. Clinical remission was defined as CDAI score less than 150.|At Week 4, 8, and 12|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).|||Percentage of participants|||Number
2640071|NCT01759264|Secondary|Mean Percent Change of Fecal Calprotectin From Baseline|Fecal calprotectin was monitored as a non-invasive surrogate marker measured by enzyme-linked immunosorbent assays. A stool sample was collected at baseline (Week 0) and every follow up visit.|Week 4, 8, and 12|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).|||Percentage||Standard Deviation|Mean
2640072|NCT01759264|Primary|Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram|Fecal calprotectin was monitored as a non-invasive surrogate marker measured by enzyme-linked immunosorbent assays. A stool sample was collected at baseline (Week 0) and every follow up visit.|At Week 4|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).|||Percentage of participants|||Number
2640073|NCT01759264|Secondary|Percentage of Participants With Fecal Calprotectin Less Than 150 Microgram/Gram|Fecal calprotectin was monitored as a non-invasive surrogate marker measured by enzyme-linked immunosorbent assays. A stool sample was collected at baseline (Week 0) and every follow up visit.|At Week 8 and 12|Intention-to-treat (ITT) population (Participants who received at least one adalimumab induction treatment and were measured for at least one primary endpoint after baseline) and Per-Protocol (PP) population (ITT participants who met inclusion/exclusion criteria and completed the study without any major protocol deviation).|||Percentage of participants|||Number
2640074|NCT01759251|Secondary|Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Patient|vertigo associated symptoms: tinnitus, hearing loss, nausea, vomiting, faintness and headache; determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.|up to 2 months|||||||
2640075|NCT01759251|Secondary|Clinical Response as Improvement of Vertigo Associated Symptoms Evaluated by Physician|vertigo associated symptoms: tinnitus, hearing loss, nausea, vomiting, faintness and headache; determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.|up to 2 months|||||||
2640076|NCT01759251|Secondary|Overall Clinical Response Assessed by Patient|determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.|up to 2 months|||||||
2640077|NCT01759251|Secondary|Overall Clinical Response Assessed by Physician|determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.|up to 2 months|||||||
2640078|NCT01759251|Secondary|Change of Vestibular Vertigo Attacks Frequency From the End of Observational Treatment Period to the End of Follow-up Period||From 2 months to 4 months|||||||
2640079|NCT01759251|Secondary|Change of Vestibular Vertigo Attacks Frequency From Baseline to the End of Observational Treatment Period||From Day 0 to 2 months|||||||
2640080|NCT01759251|Secondary|Change of the Patient's Clinical Conditions of Vestibular Vertigo From Baseline to the End of Observational Treatment Period|determined with the Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)|From Day 0 to 2 months|||||||
2640081|NCT01759251|Primary|Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)|Number of patients with clinical response on treatment determined with SVVSLCRE|Up to 2 months|60 days treatment group|||participants|||Number
2640082|NCT01759160|Secondary|CVP (Central Venous Pressure)|CVP was continuously monitored to assess preload condition and served to calculate SVRI (systemic vascular resistance index) every minute during the first 25 minutes of infusion.|25 minutes after induction|||||||
2640083|NCT01759160|Secondary|NI (Narcotrend Index) Reduction|Narcotrend was utilized to continuously record patients' sedation level during induction, provided as a criteria for Cpt (Plasma Target Concentration) adjustment.|25 minutes after propofol infusion|||||||
2656166|NCT01618942|Secondary|Time of Each Test Procedure||10 minutes after the procedure||||seconds||Standard Deviation|Mean
2640084|NCT01759160|Primary|SVI (Stroke Volume Index) Value Change From Baseline Level at the End of the First 25 Minutes.|After propofol infusion started, according to sedation level, TCI targets were gradually titrated to reach a state of equilibrium at the end of the first 25 minutes. SVI were continuously monitored, at the end of the first 25 minutes, value change from baseline level were calculated.|The end of the first 25 minutes after propofol infusion||||ml/beat/m^2||Standard Deviation|Mean
2640085|NCT01758900|Secondary|Complication Rate||Within 1 week after all the examinations are finished||||participants|||Number
2640086|NCT01758900|Secondary|Abdominal Circumference|To measure abdominal circumference, a tape was placed horizontally around the abdomen at the level of the middle location between the level of anterior superior iliac spine and the lower edge of costal arch, and the measurement was made at the end of a normal expiration before and after the procedure.|10 minutes before/after the examination||||centimeter||Standard Deviation|Mean
2640087|NCT01758900|Secondary|Procedure Time||Within 5 minutes after the examination||||minutes||Standard Deviation|Mean
2640088|NCT01758900|Secondary|Patient's Acceptability|"Acceptability was recorded on a questionnaire given to patients after the examination. Patients assessed the degree of abdominal pain/distention along a 10-cm line of the VAS(visual analogue scale), with the 0-cm point labeled no pain/distention on left end and the 10-cm point labeled very severe pain/distention that cannot be tolerated on the right end. Patients were asked to score the severity of pain/distention experienced at 1, 2, 3 and 6 hours after the completion of the entire examination."|6 hours after the examination||||participants|||Number
2640089|NCT01758900|Secondary|Diagnostic Rate||Within 1 week after all the examinations are finished||||Percentage of Participants|||Number
2640090|NCT01758900|Secondary|Total Enteroscopy Rate||Within 1 week after all the examinations are finished||||participants|||Number
2640091|NCT01758900|Primary|Intubation Depth||Within 5 minutes after the examination||||cm||Standard Deviation|Mean
2640092|NCT01758731|Primary|Maximum Tolerated Dose (MTD) of Olaparib|Maximum tolerated dose (MTD) of Olaparib to be used for Phase II clinical testing.|10 weeks from the start of protocol therapy||||mg twice daily|||Number
2640093|NCT01758588|Secondary|Overall Survival|"Overall survival measures subject survival regardless of disease progression.~Overall survival will be assessed at 21 weeks from time of study entry."|Week 21|Due to early termination of the trial, there is not enough data to evaluate overall survival.|||Participants|||Count of Participants
2640094|NCT01758588|Secondary|Progression Free Survival|"Progression free survival is the measure of subject survival in the absence of disease progression. Disease progression is defined as progression to the next higher International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Dynamic International Prognostic Scoring System (DIPSS) stage from diagnosis. The IWG-MRT DIPSS stratifies primary myelofibrosis (PMF) into four risk categories (low, intermediate 1, intermediate 2, and high risk), based on 5 clinical factors; Age>65, Hemoglobin <10gm/dL, white blood cell (WBC)>25,000/uL, peripheral blasts>1%, and constitutional symptoms.~Progression free survival will be assessed at 21 weeks from time of study entry."|Week 21|Analysis population includes subjects who were evaluable at 21 weeks from time of study entry.|||Participants|||Count of Participants
2640095|NCT01758588|Primary|Clinical Improvement|"Clinical improvement (CI) Requires one of the following in the absence of both disease progression (as outlined below) and Complete Response (CR)/Partial Response (PR) assignment (CI response is validated only if it lasts for no fewer than 8 weeks) i. A minimum 20-g/L increase in hemoglobin level or becoming transfusion independent (applicable only for patients with baseline hemoglobin level of less than 100 g/L).~ii. Either a minimum 50% reduction in palpable splenomegaly of a spleen that is at least 10 cm at baseline or a spleen that is palpable at more than 5 cm at baseline becomes not palpable.~iii. A minimum 100% increase in platelet count and an absolute platelet count of at least 50 000 109/L (applicable only for patients with baseline platelet count below 50 109/L).~iv. A minimum 100% increase in Absolute Neutrophil Count (ANC) and an ANC of at least 0.5 109/L (applicable only for patients with baseline absolute neutrophil count below 1 109/L)."|One year||||Participants|||Count of Participants
2640096|NCT01758523|Secondary|Carbohydrate-deficient Transferrin|Carbohydrate-deficient transferrin (CDT) at end of treatment as percentage of baseline. Serum CDT is a biochemical measure of heavy alcohol use.|end of 12-week treatment vs. baseline|Per protocol 12-week completers (serum sample not available for 1 placebo subject).|||percentage of baseline CDT||Standard Error|Mean
2640097|NCT01758523|Secondary|HDD/ Week by Treatment Group and AKR1C3*2 Genotype|Change in Number of days / week with 5 or more drinks consumed contrasting AKR1C3*2 CC vs. G-carrier genotype and treatment group|12-week treatment period|Modified ITT (all subjects who attended one or more post-randomization visit)|||heavy drinking days/week||Standard Error|Mean
2640098|NCT01758523|Primary|Number of Participants With no Hazardous Drinking|Number of participants with no hazardous drinking (not more than 4 drinks on one day and not more than 14 drinks per week) during the last 4 weeks of treatment.|Last 4 weeks of treatment|Per protocol 12 week treatment completers|||Participants|||Count of Participants
2640099|NCT01758523|Primary|Number of Participants With no Heavy Drinking Days|Number of participants with no heavy drinking days (days with 5 or more drinks) during the last 4 weeks of treatment.|Last 4 weeks of treatment|Per protocol 12-week completer|||Participants|||Count of Participants
2640100|NCT01758523|Primary|Drinks Per Week|Total number of drinks aggregated by week|12-week treatment period|Modified ITT (all subjects who attended one or more post-randomization visit)|||drinks/week||Standard Error|Mean
2640101|NCT01758523|Primary|Heavy Drinking Days Per Week|Number of days / study week with 5 or more drinks consumed|12-week treatment period|Modified Intention to Treat (ITT) all subjects who attended one or more post-randomization visit.|||heavy drinking days/week||Standard Error|Mean
2640102|NCT01758432|Secondary|Andexanet Apparent Terminal Elimination Half-life (t1/2)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electro chemiluminescent assay. t1/2 was determined by linear regression of the log concentration on the terminal portion of the plasma concentration-time curve.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|36 subjects who received andexanet were included in the andexanet PK analysis|||hr||Standard Deviation|Mean
2674985|NCT01451398|Secondary|Mean 7-point Glucose Baseline Values|Mean 7-point self-monitored glucose at baseline|Baseline|Full analysis set|||mg/dL||Standard Deviation|Mean
2640103|NCT01758432|Secondary|Andexanet Total Systemic Clearance (CL)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. CL was calculated using a non-compartmental approach, calculated as Dose/AUC0-inf|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|36 subjects who received andexanet were included in the andexanet PK analysis|||L||Standard Deviation|Mean
2640104|NCT01758432|Secondary|Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf )|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. AUC0-inf was calculated using a non-compartmental approach|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|36 subjects who received andexanet were included in the andexanet PK analysis|||ng*hr/mL||Standard Deviation|Mean
2640105|NCT01758432|Secondary|Andexanet Total Volume of Distribution (Vss)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Vss was calculated using a non-compartmental approach.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|36 subjects who received andexanet were included in the andexanet PK analysis|||L||Standard Deviation|Mean
2640106|NCT01758432|Secondary|Andexanet Time of Maximum Observed Plasma Concentration (Tmax)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Tmax was taken directly from the raw data.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|36 subjects who received andexanet were included in the andexanet PK analysis|||hr||Full Range|Median
2640107|NCT01758432|Secondary|Andexanet Maximum Observed Plasma Concentration (Cmax)|Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Cmax was taken directly from the raw data.|Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.|36 subjects who received andexanet were included in the andexanet PK analysis|||ng/mL||Standard Deviation|Mean
2640108|NCT01758432|Secondary|Efficacy: Percent Change From Baseline in Unbound Apixaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration|Unbound apixaban concentrations was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Unbound plasma concentrations for apixaban were determined by a rapid equilibrium dialysis method followed by Liquid Chromatography-Mass Spectometry assay.|Baseline to 2 minutes following the end of andexanet/placebo administration|54 subjects who received apixaban were included in the apixaban pharmacokinetics (PK) analysis|||% change in unbound apixaban concentrat.||Standard Deviation|Mean
2640109|NCT01758432|Secondary|Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration|Thrombin generation was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Thrombin generation was measured using a TF-initiated thrombin generation assay.|Baseline to 2 minutes following the end of andexanet/placebo administration|45 subjects who received andexanet or placebo were included in the PD analysis|||Percent change in thrombin generation||Standard Deviation|Mean
2640110|NCT01758432|Primary|Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration|Anti-fXa activity was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Anti-fXa activity was measured using a commercial kit (Coamatic Heparin-82 33 9363, DiaPharma)|Baseline to 2 minutes following the end of andexanet/placebo administration|54 subjects who received andexanet or placebo were included in the pharmacodynamics (PD) analysis|||Percent change in anti-fXa activity||Standard Deviation|Mean
2640111|NCT01758289|Secondary|Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit|BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression. The range of scores is 0 to 63, with a higher value representing a worse outcome.|Baseline Week 1 (Study Visit 1), Week 24 (Final Study Visit)|Participants with a complete, valid assessment at given time point.|||units on a scale||Standard Deviation|Mean
2640112|NCT01758289|Secondary|European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24|The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a VAS. For the VAS portion, health status is assessed by participants on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'worst imaginable health state' (0) and 'best imaginable health state' (100).|Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)|Participants with valid assessments at given time point.|||units on a scale||Standard Deviation|Mean
2640113|NCT01758289|Secondary|European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24|The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a visual analogue scale (VAS). For each parameter other than the VAS, participants are asked to indicate which of 5 statements (from 'no problem' to 'extreme problem') best describes their health state.|Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)|Participants with valid assessments at given time point.|||participants|||Number
2640114|NCT01758289|Secondary|Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks|Number of participants achieving PTH level reductions to < 300 pg/mL or 30% below Baseline in 12 weeks (Baseline to Week 12 or Week 12 to Week 24) or in 24 weeks (Baseline to Week 24).|Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)|All participants; n=number of participants with valid PTH values at given time point.|||participants|||Number
2640115|NCT01758289|Secondary|Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL|Participants who achieved PTH Levels < 300 pg/mL between the first and third study visit (Baseline to Week 12) and the third and final study visit (Week 12 to Week 24).|Baseline to Week 12, Week 12 to Week 24|All participants; n=participants with valid PTH values at given time point.|||participants|||Number
2640116|NCT01758289|Secondary|Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24|"Hypercalcemia was defined as a value of serum calcium (Ca) greater than or equal to 10.3 mg/dL.~Hyperphosphatemia was defined as a value of serum phosphorus (P) greater than or equal to 5.5 mg/dL.~Elevated Ca×P was defined as as greater or equal to 56.65 mg^2/dL^2, calculated as the result of multiplying the maximum values of calcium (10.3 mg/dL) and phosphorus (5.5 mg/dL)."|Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit)|Participants with valid assessments at given time point.|||percentage of participants|||Number
2640117|NCT01758289|Primary|Percentage of Participants Achieving at Least a 30% Reduction From Baseline in the Levels of Parathyroid Hormone (PTH) at the Final Study Visit||Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit)|Participants with valid PTH values at Baseline and Final Study Visit.|||percentage of participants|||Number
2640118|NCT01757964|Primary|Number of Participants Who Responded to Stool Translplantation By 2 Weeks as Determined by Pediatric Ulcerative Colitis Activity Index (PUCAI)/Pediatric Crohn's Disease Activity Index (PCDAI) Scoring|The primary outcome measure is based on estimating the responder rate. This is defined as the proportion of patients with response to therapy by a drop of 10 or more points in PUCAI/PCDAI scoring. PUCAI/PCDAI are validated activity indexes for pediatric Ulcerative colitis and Crohn's disease, respectively. PUCAI scoring ranges from 0 to 85, with disease remission less than 10, mild disease activity between 10 - 35, moderate disease activity from 35 - 65, and severe disease activity above 65. PCDAI scoring ranges from 0 to 100; with remission being less than 10, mild disease from 10 to 30, and moderate to severe disease greater than 30.|2 weeks||||participants|||Number
2640119|NCT01757847|Secondary|Change From Baseline in The Obesity-related Well Being Scale (ORWELL-97) at 4 Weeks, 3 Months, and 6 Months|The ORWELL-97 is a self-report measure of obesity-related quality of life. It has been validated on obese patients. The total score ranges from 0-162 with higher scores indicating lower quality of life and decreasing scores indicating improvement in the outcome.|post treatment (4 weeks), 3 months, 6 months|Participants with measurement at baseline and at least one other time point.|||units on a scale||Standard Deviation|Mean
2640120|NCT01757847|Primary|Change From Baseline in Binge Eating Scale (BES) at 4 Weeks, 3 Months and 6 Months|This measure contains 16 questions that describe both behavioral and emotional manifestations of a binge episode. This scale was specifically developed to assess binge eating severity and associated emotional distress in overweight and obese individuals. The total score for the measure ranges from 0-46 points with higher scores indicating greater problems with binge eating and lower scores indicating better outcome.|post treatment (4 weeks), 3 months, 6 months|participants with measurement at baseline and at least one other time point.|||units on a scale||Standard Deviation|Mean
2640121|NCT01757821|Primary|Change in Cortical Excitability: Paired-Pulse|Cortical Excitability of the primary motor cortex on the stroke hemisphere will be assessed using paired-pulse transcranial magnetic stimulation.|Change from Baseline to 20 minutes||||milivolt||Standard Deviation|Mean
2640122|NCT01757717|Secondary|Number of Grade 3 of Higher Toxicities|For previously irradiated lesions of the spine and/or pelvis, defined as an acceptable level of severe toxicity (both acute and late effects) in the setting of HDR brachytherapy treatment. Severe toxicity will be defined as ≥ grade 3 NCI CTCAE v 4.0 toxicity that is at least possibly related to treatment|1 year||||brachytherapy related complications|||Number
2640123|NCT01757717|Primary|Maximum Radiation Dose|Verify feasibility of HDF treatment of spinal and/or pelvic lesions using catheters placed under image-guided navigational techniques, to provide improved dosimetric coverage of lesions such that Cord/Cauda Dmax of <8 Gy|1 year||||cord/cauda max dose in Gy||Full Range|Median
2640124|NCT01757704|Primary|Duration of the De-airing Procedure|The de-airing procedure is deemed completed when the Trans-esophageal Echocardiography (TEE) no longer visualizes air emboli in the heart Chambers. The duration is likely to vary between individuals and reflects the complexity of the de-airing procedure.|Time from release of aortic crossclamp to finished de-airing||||Minutes||Inter-Quartile Range|Median
2640125|NCT01757704|Primary|Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.|The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.|6-10 minutes after finished de-airing||||Participants|||Number
2640126|NCT01757704|Primary|Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.|The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.|3-6 minutes after finished de-airing||||Participants|||Number
2640127|NCT01757704|Primary|Participants With <=Grade I Air Emboli as Assessed by Trans-esophageal Echocardiography (TEE) After Finished De-airing.|The severity of residual air emboli in three anatomic areas; left atrium, left ventricle and aortic root, is assessed by Trans-esophageal Echocardiography (TEE) and classified in grade 0-3 as follows, Grade o: no residual air; grade I: gas emboli detected in one of three anatomic areas during one cardiac cycle; grade II: gas emboli detected simultaneously in two of three anatomic areas during one cardiac cycle; grade III: gas emboli detected simultaneously in all three anatomic areas during one cardiac cycle.|0-3 minutes after finished de-airing||||Participants|||Number
2640128|NCT01757704|Primary|Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery|Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and left middle cerebral artery will be reported.|Period of ten minutes after finished de-airing||||Air microemboli||Inter-Quartile Range|Median
2640129|NCT01757704|Primary|Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery|Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and left middle cerebral artery will be reported.|Time from cardiac ejection to finished de-airing, an average of 5-10 minutes||||Air microemboli||Inter-Quartile Range|Median
2640130|NCT01757704|Primary|Quantitative Assessment of Air Embolism to the Brain After Completion of Open Left Heart Surgery|Cerebral air emboli will be assessed quantitatively by On-line counting of gaseous microembolic signals (MES) by Trans-cranial Echo-Doppler (TCD) monitoring of the right and left middle cerebral artery. The sum of the gaseous microembolic signals registered from the right and left middle cerebral artery will be reported.|Time from the release of the aortic crossclamp to cardiac ejection, an average of 10-15 minutes||||Air microemboli||Inter-Quartile Range|Median
2640131|NCT01757691|Secondary|Number of Particpants With Adverse Events as a Measure of Safety and Tolerability|Number of particpants with Adverse events as a measure of safety and tolerability|Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60|Safety population consited of all patients who received at least one dose of study medication|||Participants|||Number
2640132|NCT01757691|Secondary|Proportion of Paatients Converting to Either 2005 or 2010 McDonald MS or to CDMS|Due to early termination and low patient enrollment this trial was not powered for efficacy|Baseline, Week 18, Week 48|||||||
2640133|NCT01757691|Secondary|Vision Based Quality of Life (QoL) Utility Score|Due to early termination and low patient enrollment this trial was not powered for efficacy|Baseline, Week 18, Week 48|||||||
2640134|NCT01757691|Secondary|Low Contrast Visual Acuity (LCVA)|Due to early termination and low patient enrollment this trial was not powered for efficacy|Baseline, Week 48|||||||
2640135|NCT01757691|Primary|Mean Retinal Nerve Fiber Layer (RNFL) Thinning in Patients Treated With Fingolimod 0.5mg/Day, Relative to Patients Treated With Placebo|Due to early termination and low patient enrollment the primary outcome measure was not analyzed|Baseline and Week 18|||||||
2640136|NCT01757678|Post-Hoc|Per-Patient Diagnostic Performance of FFRct in Patients With Intermediate Stenosis Severity (30%-70%) According to Coronary CTA||1 day; Outcome measures were comparing FFRct to FFR. Incident time for FFR was dependent on the length of time on the cath procedure. FFRct was done remotely at HeartFlow's processing center in Redwood City with a turnaround time of 24 hours from CT scan.|Patients with intermediate stenosis severity (30%-70%) according to coronary CTA.|||percentage of tests||95% Confidence Interval|Number
2640137|NCT01757678|Secondary|Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA||1 day; Outcome measures were comparing FFRct to FFR. Incident time for FFR was dependent on the length of time on the cath procedure. FFRct was done remotely at HeartFlow's processing center in Redwood City with a turnaround time of 24 hours from CT scan.|22 of the 276 enrolled subjects were excluded from the analysis by the FFR/QCA Core Lab.|||percentage of tests|Vessels|95% Confidence Interval|Number
2640138|NCT01757678|Secondary|Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA||1 day; Outcome measures were comparing FFRct to FFR. Incident time for FFR was dependent on the length of time on the cath procedure. FFRct was done remotely at HeartFlow's processing center in Redwood City with a turnaround time of 24 hours from CT scan.|22 of the 276 enrolled subjects were excluded from the analysis by the FFR/QCA Core Lab.|||percentage of tests||95% Confidence Interval|Number
2640139|NCT01757678|Primary|AUC of FFRct Versus Coronary CTA for Demonstration of Ischemia (≤0.80) on a Per-patient Basis|The primary statistical measure will be the area under the receiver operating characteristic curve (AUC of ROC) of a patient-based model to detect hemodynamically significant obstruction. ROC graphs the change in sensitivity as the cut-point for positive/negative diagnosis moves from its lower to upper limit. FFR is used as the reference standard to determine the presence or absence of hemodynamic obstruction. For FFR, hemodynamically-significant obstruction of a coronary artery is defined as an FFR≤0.80 in any major epicardial coronary artery segment with diameter ≥2.0 mm during adenosine-mediated hyperemia. For cCTA, hemodynamically-significant obstruction of a coronary artery is defined as a stenosis >50% . FFRCT will be calculated for each patient as the minimum FFRCT in any coronary artery segment . cCTA stenosis will be calculated for each patient as the highest cCTA stenosis category for any vessel all measurements will take place only in segments with diameter ≥2.0 mm.|1 day; Outcome measures were comparing FFRct to FFR. Incident time for FFR was dependent on the length of time on the cath procedure. FFRct was done remotely at HeartFlow's processing center in Redwood City with a turnaround time of 24 hours from CT scan.|22 of the 276 enrolled subjects were excluded by the FFR/QCA Core Lab, leaving an ITD population of 254 subjects. 3 additional subjects were excluded from the ITD analysis due to missing cCTA 30%-90% stenosis by coronary CTA.|||probablility||95% Confidence Interval|Number
2640140|NCT01757678|Secondary|AUC of FFRct Versus Coronary CTA for Demonstration of Ischemia (≤0.80) on a Per-vessel Basis||1 day|22 of the 276 enrolled subjects were excluded by the FFR/QCA Core Lab, leaving an ITD population of 254 subjects. 3 additional subjects were excluded from the ITD analysis due to missing cCTA 30%-90% stenosis by coronary CTA.|||probability|Vessels|95% Confidence Interval|Number
2640141|NCT01757665|Other Pre-specified|Subjects Average Serum Glycerol Levels|Laboratory analysis of serum glycerol in blood drawn from subjects. This blood test measures the amount of glycerol (a naturally occurring carbohydrate, that can be used as a fuel source by the body) in the serum (liquid portion of the blood).|Pre-Implant (post-heparinization) and Post-Implant (between 60 and 120 minutes after heart was restarted)|The outcome is reported for subjects who received the Model 11000A device where data is available.|||micromol/L||Standard Deviation|Mean
2640142|NCT01757665|Other Pre-specified|Subject's Average Prothrombin Time|Laboratory Analysis of Prothrombin Time (PT) on blood drawn from subjects. The PT is a blood test that measures the time it takes for the plasma (liquid portion of the blood) to clot.|Baseline, Discharge, 3 Months, 1 Year, and 2 Years|The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.|||Seconds||Standard Deviation|Mean
2640143|NCT01757665|Other Pre-specified|Subject's Average Partial Thromboplastin Time|Laboratory Analysis of partial thromboplastin time (PTT) on blood drawn from subjects. PTT is a blood test that looks at how long it takes for the blood to clot.|Baseline, Discharge, 3 Months, 1 Year and 2 Year|The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.|||Seconds||Standard Deviation|Mean
2640144|NCT01757665|Other Pre-specified|Subject's Average International Normalized Ratio|Laboratory Analysis of International Normalized Ratio (INR) on blood drawn from subjects. The INR is a calculation based on results of a prothrombin time (PT). The PT is a blood test that measures the time it takes for the plasma (liquid portion of the blood) to clot. INR results will vary according to a person's age, the medicines they take, and any health problems they may have. In general, the higher the INR number, the longer it takes for the blood to clot. In healthy people an INR of 1.1 or below is considered normal. An INR range of 2.0 to 3.0 is generally an effective therapeutic range for people taking blood thinner medication.|Baseline, Discharge, 3 Months, 1 Year and 2 Year|The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.|||Ratio||Standard Deviation|Mean
2640145|NCT01757665|Other Pre-specified|Subject's Average Plasma Free Hemoglobin|Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood).|Baseline, Discharge, 3 Months, 1 Year and 2 Year|The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.|||mg/dl||Standard Deviation|Mean
2640146|NCT01757665|Other Pre-specified|Subject's Average Platelet Count|Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.|Baseline, Discharge, 3 Months, 1 Year, and 2 Years|The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.|||10^3 platelets per microliter||Standard Deviation|Mean
2640147|NCT01757665|Other Pre-specified|Subject's Average Hemoglobin Count|Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.|Baseline, Discharge, 3 Months, 1 Year and 2 Year|The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.|||g/dl||Standard Deviation|Mean
2640148|NCT01757665|Other Pre-specified|Subject's Average Hematocrit Percentage|Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the plasma (liquid portion of the blood).|Baseline, Discharge, 3 Months, 1 Year and 2 Year|The outcome is reported for subjects who received the Model 11000A or 11000M device where data is available.|||percentage of red blood cells||Standard Deviation|Mean
2640149|NCT01757665|Other Pre-specified|Subject's Average Red Blood Cells Count|Laboratory Analysis of Red Blood Cell (RBC) Count on blood drawn from subjects; RBC carry oxygen.|Baseline, Discharge, 3 Months, 1 Year and 2 Year|The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.|||10^6 cells/microliters||Standard Deviation|Mean
2640150|NCT01757665|Other Pre-specified|Subject's Average White Blood Cell Count|Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection.|Baseline, Discharge, 3 Months, 1 Year and 2 Year|The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.|||10^3 cells /microliter||Standard Deviation|Mean
2640151|NCT01757665|Other Pre-specified|Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey|"The Medical Outcomes Study Short-Form 12 (SF-12) contains two components - the Physical Component Summary (PCS) and the Mental Component Summary (MCS).~The SF-12 Physical Component Summary questionnaire scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status.~The SF-12 Mental Component Summary scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status."|Baseline and one year post-implant|The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.|||units on a scale||Standard Deviation|Mean
2640152|NCT01757665|Other Pre-specified|Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).~Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).~Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.~Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases."|3 Months, 1 Year, and 2 Years Post Implant|The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.|||Participants|||Count of Participants
2640153|NCT01757665|Other Pre-specified|Subject's Amount of Paravalvular Leak Over Time - 11000M|"Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.~Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome."|3 Months, 1 Year, and 2 Years Post Implant|The outcome is reported for subjects who received the Model 11000M device where data is available.|||Participants|||Count of Participants
2640154|NCT01757665|Other Pre-specified|Subject's Amount of Paravalvular Leak Over Time - 11000A|"Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing.~Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome."|3 Months, 1 Year, and 2 Years Post Implant|The outcome is reported for subjects who received the Model 11000A device where data is available.|||Participants|||Count of Participants
2640155|NCT01757665|Other Pre-specified|Subject's Amount of Total Valvular Regurgitation Over Time - 11000M|Mitral valvular regurgitation occurs when the mitral valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Mitral valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.|3 Months, 1 Year, and 2 Years Post Implant|The outcome is reported for subjects who received the Model 11000M device where data is available.|||Participants|||Count of Participants
2641089|NCT01749956|Secondary|Overall Survival Probability at 6 and 12 Months|The probability of overall survival at 6 months and 12 months from date of first protocol treatment until date of death.|up to 1 year||||probability||95% Confidence Interval|Number
2640156|NCT01757665|Other Pre-specified|Subject's Amount of Total Valvular Regurgitation Over Time - 11000A|Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.|3 Months, 1 Year, and 2 Years Post Implant|The outcome is reported for subjects who received the Model 11000A device where data is available.|||Participants|||Count of Participants
2640157|NCT01757665|Other Pre-specified|Subject's Average Cardiac Index Over Time - 11000M|Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area(BSA), thus relating heart performance to the size of the individual.|3 Months, 1 Year, and 2 Years Post Implant|The outcome is reported for subjects who received the Model 11000M device where data is available.|||L/min/m^2||Standard Deviation|Mean
2640158|NCT01757665|Other Pre-specified|Subject's Average Cardiac Index Over Time- 11000A|Cardiac index is an assessment that divides the cardiac output from left ventricle in one minute by the person's body surface area (BSA), thus relating heart performance to the size of the individual.|3 Months, 1 Year, and 2 Years Post Implant|The outcome is reported for subjects who received the Model 11000A device where data is available.|||L/min/m^2||Standard Deviation|Mean
2640159|NCT01757665|Other Pre-specified|Subject's Average Cardiac Output Over Time - 11000M|The amount of blood the heart pumps through the circulatory system in a minute.|3 Months, 1 Year, and 2 Years Post Implant|The outcome is reported for subjects who received the Model 11000M device where data is available.|||Liters/Minute||Standard Deviation|Mean
2640160|NCT01757665|Other Pre-specified|Subject's Average Cardiac Output Over Time - 11000A|The amount of blood the heart pumps through the circulatory system in a minute.|3 Months, 1 Year, and 2 Years Post Implant|The outcome is reported for subjects who received the Model 11000A device where data is available.|||Liters/minute||Standard Deviation|Mean
2640161|NCT01757665|Other Pre-specified|Subject's Average Performance Index Measurements - 11000M|Performance index is defined as the subject's effective orifice area (the crosssectional area of the blood flow downstream of the mitral valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time.|3 Months, 1 Year, and 2 Years Post Implant|The outcome is reported for subjects who received the Model 11000M device where data is available.|||cm^2/m^2||Standard Deviation|Mean
2640162|NCT01757665|Other Pre-specified|Subject's Average Performance Index Measurements - 11000A|Performance index is defined as the subject's effective orifice area (the cross sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time.|3 Months, 1 Year, and 2 Years Post Implant|The outcome is reported for subjects who received the Model 11000A device where data is available.|||cm^2/m^2||Standard Deviation|Mean
2640163|NCT01757665|Other Pre-specified|Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000M|Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.|3 Months, 1 Year, and 2 Years Post Implant|The outcome is reported for subjects who received the Model 11000M device where data is available.|||cm^2/m^2||Standard Deviation|Mean
2640164|NCT01757665|Other Pre-specified|Subject's Average Effective Orifice Area Index (EOAI) Measurements - 11000A|Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.|3 Months, 1 Year, and 2 Years Post Implant|The outcome is reported for subjects who received the Model 11000A device where data is available.|||cm^2/m^2||Standard Deviation|Mean
2640165|NCT01757665|Other Pre-specified|Subject's Average Effective Orifice Area Measurements - 11000M|Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time.|3 Months, 1 Year, and 2 Years Post Implant|The outcome is reported for subjects who received the Model 11000M device where data is available.|||Centimeters Squared||Standard Deviation|Mean
2640166|NCT01757665|Other Pre-specified|Subject's Average Effective Orifice Area Measurements - 11000A|Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.|3 Months, 1 Year, and 2 Years Post Implant|The outcome is reported for subjects who received the Model 11000A device where data is available.|||Centimeters Squared||Standard Deviation|Mean
2640167|NCT01757665|Other Pre-specified|Subject's Average Peak Gradients Measurements Over Time - 11000M|Peak gradient is the maximum value measured of flow of blood through the mitral valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.|3 Months, 1 Year, and 2 Years Post Implant|The outcome is reported for subjects who received the Model 11000M device where data is available.|||mmHg||Standard Deviation|Mean
2640168|NCT01757665|Other Pre-specified|Subject's Average Peak Gradients Measurements Over Time - 11000A|Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.|3 Months, 1 Year, and 2 Years Post Implant|The outcome is reported for subjects who received the Model 11000A device where data is available.|||mmHg||Standard Deviation|Mean
2640169|NCT01757665|Other Pre-specified|Subject's Average Mean Gradient Measurements - 11000M|Mean gradient is the average flow of blood through the mitral valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.|3 Months, 1 Year, and 2 Years Post Implant|The outcome is reported for subjects who received the Model 11000M device where data is available.|||mmHg||Standard Deviation|Mean
2640170|NCT01757665|Other Pre-specified|Subject's Average Mean Gradient Measurements - 11000A|Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.|3 Months, 1 Year, and 2 Year Post Implant|The outcome is reported for subjects who received the Model 11000A device where data is available.|||mmHg||Standard Deviation|Mean
2640257|NCT01756352|Primary|Progression-free Survival|The primary objective is to assess the utility of FET-PET imaging for prediction of progression-free survival in recurrent glioblastoma.|From date of baseline PET scan until the date of death from any cause, assessed up to 2 years.||||days||Standard Deviation|Mean
2640171|NCT01757665|Secondary|Percentage of Late Adverse Events Divided by Late Patient Years|Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).|Events occurring >= 31 days and up through 3 years post-implant|The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.|||percentage of events/late patient years|||Number
2640172|NCT01757665|Secondary|Percentage of Subjects With Early Adverse Events|Number of subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100|Events occuring within 30 days of procedure|The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available.|||percentage of subjects|||Number
2640173|NCT01757665|Primary|Subjects With Structural Valve Deterioration|The rate of implanted subjects that experience structural valve deterioration (SVD) of the trial valve by the time of the post operative day (POD) 390 follow‐up visit. Structural valve deterioration includes dysfunction or deterioration intrinsic to the valve. Examples of SVD includes complications such as wear, fracture, calcification, leaflet tear.|1 Year Post Implant|The outcome is reported for subjects who received the Model 11000A or Model 11000M device where data is available. The SVD result combines the aortic and mitral implanted subjects. The study was powered for the combined cohort for this endpoint as there would be too few mitral subjects to report the arms separately.|||Participants|||Count of Participants
2640174|NCT01757561|Other Pre-specified|Blood Gas Analysis|including artery blood and blood from jugular vein bulb|baseline,every hour in the operation,after extubation|||||||
2640175|NCT01757561|Other Pre-specified|Vital Signs|heart rate, artery blood pressure,pulse oxygen saturation,temperature|baseline , evey hour in the operation,afte extubation|||||||
2640176|NCT01757561|Secondary|the Change in the Level of Serum s-100β Between Propofol and Sevoflurane Anesthesia||before anesthesia,after extubation,1 day after operation|||||||
2640177|NCT01757561|Secondary|the Change in the Level of Serum BDNF(Brain-derived Neurotrophic Factor ) Between Propofol and Sevoflurane Anesthesia||before anesthesia, after extubation ,1day after operation|||||||
2640178|NCT01757561|Secondary|the Incidence of Postoperative Cognitive Disfunction(POCD)Between Propofol and Sevoflurane General Anesthesia|The incidence of early POCD was recorded. The MMSE score and the Montreal cognitive assessment (MoCA) score were recorded 1day before surgery, 1-3 day after surgery and 5-7 day after surgery. The POCD was defined as MMSE score illiterate group ≤ 17, primary and secondary school group ≤ 20, junior high school and above group ≤ 24，or the MoCA score decreased 20% with the baseline.|1-3days、5-7days after operation||||participants|||Number
2640179|NCT01757561|Primary|the Incidence of Intraoperative Desaturation Between Propofol and Sevoflurane General Anesthesia|SjvO2 were measured before anesthesia, after intubation, every hour during operation, after extubation by jugular vein blood and atrial blood gas analysis.The incidence of intraoperative cerebral desaturation was recorded when SjvO2<50%.|baseline ,every hour in the operation period,after extubation||||participants|||Number
2640180|NCT01757405|Secondary|Percentage of Participants With Inhibitor Development to FVII|Development of rFVII inhibitors or FVIIa binding antibodies during the study.|6 months (throughout study period)|Safety Analysis Dataset|||percent of participants|||Number
2640181|NCT01757405|Secondary|Safety and Tolerability of Treatment Regimens by Clinical Assessment of Adverse Events (AEs)|"Safety was determined by the number of AEs (both serious AEs [SAEs] and non-serious AEs [nsAE]).~Tolerability was determined by the number of AEs related to rFVIIa BI (both SAEs and nsAEs) as determined by causality assessment of the AEs by the investigator. An AE was deemed Related if the investigator judges the AE to be possibly related or probably related to rFVIIa BI.~The percentage of AEs were presented by seriousness (SAE, nsAE), severity (Mild, Moderate or Severe) and causality (Related or Not Related [to rFVIIa BI])."|6 months (throughout study period)|Safety Analysis Dataset|||percent of AEs|adverse events||Number
2640182|NCT01757405|Secondary|Safety and Tolerability of Treatment Regimens by Clinical Assessment of Percentage of Participants With Adverse Events (AEs)|"Safety was determined by the number of AEs (both serious AEs [SAEs] and non-serious AEs [nsAE]).~Tolerability was determined by the number of AEs related to rFVIIa BI (both SAEs and nsAEs) as determined by causality assessment of the AEs by the investigator. An AE was deemed Related if the investigator judged the AE to be possibly related or probably related to rFVIIa BI.~The percentage of participants with AEs were presented by seriousness (SAE, nsAE), severity (Mild, Moderate or Severe) and causality (Related or Not Related to rFVIIa BI)."|6 months (throughout study period)|Safety Analysis Dataset|||percent of participants with AEs|||Number
2640183|NCT01757405|Secondary|Percentage of Clinical Responders (Sustained Bleeding Control) for All Acute Bleeding Episodes|Clinical responders defined as sustained bleeding control, (no additional hemostatic medication including rFVIIa BI required between 12 and 24 hours after first infusion of the successfully treated bleeding episode).|24 hours post infusion|Full Analysis Dataset|||percent of bleeding episodes|Bleeding Episodes|95% Confidence Interval|Number
2640184|NCT01757405|Secondary|Treatment Response for Each Bleeding Episode|"Participants rated the treatment of each bleeding episode. If treatment occurred under direct supervision of treating physician, the physician rated the response.~Ratings based on a 4 point scale; EXCELLENT - full relief of pain and cessation of objective signs of bleeding (swelling, tenderness, decrease in range of motion [for muscle bleeds]) within 9 hours of treatment initiation. No additional infusion required to control bleeding, other than prescribed dosing regimen.~GOOD - Substantial relief of pain and/or cessation of objective signs of bleeding within 9 hours of treatment initiation. No additional infusion required to control bleeding, other than prescribed dosing regimen.~MODERATE - slight relief of pain and slight improvement of signs of bleeding within 9 hours of treatment initiation. Requires additional infusion beyond treatment regimen.~NONE - No improvement or condition worsens. SUCCESSFUL = EXCELLENT or GOOD."|within 24 hours of infusion|Full Analysis Dataset|||percent of bleeding episodes|Bleeding Episodes|95% Confidence Interval|Number
2640185|NCT01757405|Primary|"Percentage of Bleeding Episode With Treatment Success"|No additional hemostatic product required within 12 hours of first dose other than the prescribed dosing regimen.|within 12 hours of first dose|Full Analysis Dataset|||percent of bleeding episodes|Bleeding Episodes|95% Confidence Interval|Number
2641172|NCT01748071|Secondary|Mean Respiratory Frequency|According to the measurement of respiratory frequency after intravenous injection of opioid analgesics|10 minutes after the procedure||||breaths per minute||Standard Deviation|Mean
2640186|NCT01757301|Secondary|Brief Pain Inventory (BPI)|The BPI rates the intensity of pain on 4 items (current, worst, least, and average pain in past week), and the interference in 7 areas (mood, physical activity, work, social activity, relations with others, sleep, enjoyment of life). Minimum value = 0; maximum value = 10. Higher scores indicate greater symptom severity/worse outcomes.|12 months|Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.|||units on a scale||Standard Deviation|Mean
2640187|NCT01757301|Secondary|Generalized Anxiety Disorder 7-Item Anxiety Scale (GAD-7)|The GAD-7 is an anxiety severity measure, validated in several thousand primary care patients and increasingly used in clinical research and practice. It is also a good first-line measure for estimating the probability of 4 common anxiety disorders in primary care - generalized anxiety disorder, panic disorder, post-traumatic stress disorder, and social anxiety disorder. Minimum value = 0; maximum value = 21. Higher scores indicate greater symptom severity/worse outcomes.|12 months|Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.|||units on a scale||Standard Deviation|Mean
2640188|NCT01757301|Secondary|Patient Health Questionnaire 9-item Depression Scale (PHQ-9)|The PHQ-9 has been used in hundreds of research studies as a depression severity and outcome measure and, now translated into more than 80 languages, is among the most widely used depression measures in clinical practice. Minimum value = 0; maximum value = 27. Higher scores indicate greater symptom severity/worse outcomes.|12 months|Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.|||units on a scale||Standard Deviation|Mean
2640189|NCT01757301|Secondary|Pain Average/Enjoyment of Life/General Activities Pain Scale (PEG)|The PEG is a 3-item validated version of the Brief Pain Inventory. Minimum value = 0; maximum value = 10. Higher scores indicate greater symptom severity/worse outcomes.|12 months|Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.|||units on a scale||Standard Deviation|Mean
2640190|NCT01757301|Primary|Composite Z-score of Pain-anxiety-depression Severity|The primary outcome measure is the composite z-score of the main pain, anxiety, and depression measures in this trial: the BPI, GAD-7, PHQ-9, respectively. A standard z-score is calculated for each scale as follows: subject's scale score minus the sample mean divided by the sample standard deviation. A composite pain-anxiety-depression score is the average of the standard z-scores for the 3 scales. This is a scale of effect size where 0 represents no change from baseline, and a negative number means improvement and a positive number means worsening. Each unit means one standard deviation change from the group at baseline. Practical minimum value= -2.0, maximum value= +2.0. Positive number indicates greater symptoms severity/worse outcomes.|12 months|Seven participants in the CSM group and seven participants in the ASM group had no follow-up assessments after baseline and were therefore not included in the primary MMRM analysis since at least one follow-up data point is required for MMRM.|||units on a scale||Standard Deviation|Mean
2640191|NCT01757275|Secondary|Number of Blood Units Transfused Within 30 Days||within 30 days|FAS|||blood units|||Number
2640192|NCT01757275|Secondary|Number of Blood Units Transfused Within 72 Hours||within 72 hours|FAS|||blood units|||Number
2640193|NCT01757275|Secondary|Number of Patients With Surgery Due to Rebleeding Within 30 Days||within 30 days|FAS|||participants|||Number
2640194|NCT01757275|Secondary|Number of Patients With Surgery Due to Rebleeding Within 72 Hours||within 72 hours|FAS|||participants|||Number
2640195|NCT01757275|Secondary|Number of Patients With Endoscopic Re-treatment Within 30 Days||30 days|FAS|||participants|||Number
2640196|NCT01757275|Secondary|Number of Patients With Endoscopic Re-treatment Within 72 Hours||72 hours|FAS|||participants|||Number
2640197|NCT01757275|Secondary|Rate of Clinically Significant Rebleeding During 30 Days|"Diagnostic criteria for clinically significant rebleeding based on either A, B or C:~A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2.~A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib).~B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation).~C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator."|30 days|FAS|||participants|||Number
2640198|NCT01757275|Secondary|Rate of Clinically Significant Rebleeding During 7 Days|"Diagnostic criteria for clinically significant rebleeding based on either A, B or C:~A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2.~A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib).~B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation).~C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator."|7 days|FAS|||participants|||Number
2640283|NCT01756235|Secondary|Mean Change From Baseline in SQUASH-A Scores|SQUASH subscores capture physical activity. SQUASH-A subscore captures commuting activities, with scores ranging from 0 to 4082.400. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
2640199|NCT01757275|Primary|Rate of Clinically Significant Rebleeding Within 72 Hours|"Diagnostic criteria for clinically significant rebleeding based on either A, B or C:~A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2.~A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib).~B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb >20g/L (or Hct >6%) during 24 hours or an increase in Hb <10g/L (or Hct <3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation).~C) Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator."|72 hours|Full analysis set (FAS). All randomised patients, who started the randomised iv treatment (bolus dose), were included in the FAS.|||participants|||Number
2640200|NCT01757197|Secondary|Effect of Toclizumab on Karnofsky Performance Status|We were unable to evaluate the effect of tocilizumab on Karnofsky Performance Status at 1 year. All subjects enrolled on this study died before this time point and the study closed to enrollment due to slow accrual.|1 year|||||||
2640201|NCT01757197|Secondary|Toclizumab Response in Each Organ|We were unable to assess the Tocilizumab response in each organ at 1 year. All subjects enrolled on this study died before this time point and the study closed to enrollment due to slow accrual.|1 year|||||||
2640202|NCT01757197|Secondary|Disease-free Overall Survival at 100 Days, 6 Months and One Year From the Time of the First Tocilizumab Infusion.|We were unable to evaluate disease-free survival at 100 days, 6 months and one year from the time of the first tocilizumab infusion. All subjects enrolled on this study died before this time point and the study closed to enrollment due to slow accrual.|Approximately 1 year|We were unable to evaluate disease-free survival at 100 days, 6 months and one year from the time of the first tocilizumab infusion. All subjects enrolled on this study died before this time point and the study closed to enrollment due to slow accrual.||||||
2640203|NCT01757197|Primary|Number of Subjects With GVHD Who Are Tolerable to Tocilizumab After Having Failed Response to Glucocorticosteroid Treatment|Both subjects enrolled on this study experienced failed response to glucocorticosteroid treatment but were able to tolerate tocilizumab. We were unable to collect extensive data on these 2 subjects because they both died early on in the study due to disease complications.|Day 28|Not evaluable.|||Participants|||Count of Participants
2640204|NCT01757184|Secondary|Percent Change From Baseline In Liver Volume|Relative reduction (percent change from baseline) in liver volume, as assessed by MRI, was evaluated in participants for whom imaging was performed. Baseline for the Open-label Period was defined relative to the first infusion of sebelipase alfa, which occurred at Week 0 for participants in the sebelipase alfa/sebelipase alfa group and Week 22 for participants in the placebo/sebelipase alfa group. The last open-label assessment varied by participant, depending on whether a participant completed treatment through Week 256 or discontinued prior to this timepoint to transition out of clinical study settings.|Double-blind Period: Baseline to the end of the Double-blind Period (Week 20). Open-label Period: Baseline to the last Open-label assessment (up to Week 256).|"Double-blind Period: All participants in the Full Analysis Set (defined as participants who received at least 1 dose [or any portion of a dose] of sebelipase alfa or placebo).~Open-Label Period: All participants in the Extension Set (defined as participants who received at least 1 dose [or any portion of a dose] of sebelipase alfa)."|||percent change||Standard Deviation|Mean
2640205|NCT01757184|Secondary|Participants With Improvement In Liver Histopathology (Decrease Of > 5% In Hepatic Steatosis Score)|The number of participants who had an improvement in hepatic histopathology (defined as a decrease of > 5% in hepatic steatosis score, assessed by morphometry), as determined by blinded central pathologist review, in the participants for whom liver biopsy was performed. Baseline for the Open-label Period was defined relative to the first infusion of sebelipase alfa, which occurred at Week 0 for participants in the sebelipase alfa/sebelipase alfa group and Week 22 for participants in the placebo/sebelipase alfa group.|Double-blind Period: Baseline to the end of the Double-blind Period (Week 20). Open-label Period: Baseline up to Week 52.|"Double-blind Period: All participants in the Full Analysis Set (defined as participants who received at least 1 dose [or any portion of a dose] of sebelipase alfa or placebo).~Open-Label Period: All participants in the Extension Set (defined as participants who received at least 1 dose [or any portion of a dose] of sebelipase alfa)."|||participants|||Number
2640206|NCT01757184|Secondary|Percent Change From Baseline In Liver Fat Content|Decrease in liver fat content, as assessed by magnetic resonance imaging (MRI), was evaluated in participants for whom imaging was performed. Baseline for the Open-label Period was defined relative to the first infusion of sebelipase alfa, which occurred at Week 0 for participants in the sebelipase alfa/sebelipase alfa group and Week 22 for participants in the placebo/sebelipase alfa group. The last open-label assessment varied by participant, depending on whether a participant completed treatment through Week 256 or discontinued prior to this timepoint to transition out of clinical study settings.|Double-blind Period: Baseline to the end of the Double-blind Period (Week 20). Open-label Period: Baseline to the last Open-label assessment (up to Week 256).|"Double-blind Period: All participants in the Full Analysis Set (defined as participants who received at least 1 dose [or any portion of a dose] of sebelipase alfa or placebo).~Open-Label Period: All participants in the Extension Set (defined as participants who received at least 1 dose [or any portion of a dose] of sebelipase alfa)."|||percent change||Standard Deviation|Mean
2640229|NCT01756456|Secondary|Percentage of Participants With Abnormal Eye Structures by Dilated Fundus Ophthalmoscopy|"Dilated fundus ophthalmoscopy was performed to assess the vitreous, retina, macula, choroid and optic nerve head after dilation of the pupil.~Percentage of patients is summarized for each eye structure by treatment and visit for the controlled treatment period for Phase I and Phase II separately.~The assessment time points were Baseline, weeks 2, 4 and 8 for Phase 1; Baseline and week 8 for Phase 2; and weeks 12 and 56 for follow up.~Only results for eye structure at week 8 are reported."|At week 8 (Phase 1 and Phase 2)|safety population|||percentage of participants|||Number
2640230|NCT01756456|Secondary|Change From Baseline in Intraocular Pressure (IOP)|IOP was measured using a Goldmann applanation tonometer, a handheld applanation tonometer [eg, Tonopen], or other tonometer, after the instillation of a topical anesthetic.|Baseline, period 1 (8 weeks) and 2 (Follow Up period of 12 weeks, until week 20).|safety population|||mmHg||Standard Deviation|Mean
2640207|NCT01757184|Secondary|Percent Change From Baseline In High-density Lipoprotein Cholesterol (HDL-C)|Relative increase (percent change from baseline) in HDL-C, assessed by laboratory measurements, was evaluated at the end of the Double-blind Period and the Open-label Period. Baseline for the Open-label Period was defined relative to the first infusion of sebelipase alfa, which occurred at Week 0 for participants in the sebelipase alfa/sebelipase alfa group and Week 22 for participants in the placebo/sebelipase alfa group. The last open-label assessment varied by participant, depending on whether a participant completed treatment through Week 256 or discontinued prior to this timepoint to transition out of clinical study settings.|Double-blind Period: Baseline to the end of the Double-blind Period (Week 20). Open-label Period: Baseline to the last Open-label assessment (up to Week 256).|"Double-blind Period: All participants in the Full Analysis Set (defined as participants who received at least 1 dose [or any portion of a dose] of sebelipase alfa or placebo).~Open-Label Period: All participants in the Extension Set (defined as participants who received at least 1 dose [or any portion of a dose] of sebelipase alfa)."|||percent change||Standard Deviation|Mean
2640208|NCT01757184|Secondary|Percent Change From Baseline In Triglycerides|Relative reduction (percent change from baseline) in triglycerides, as assessed by laboratory measurements, was evaluated at the end of the Double-blind Period and the Open-label Period. Baseline for the Open-label Period was defined relative to the first infusion of sebelipase alfa, which occurred at Week 0 for participants in the sebelipase alfa/sebelipase alfa group and Week 22 for participants in the placebo/sebelipase alfa group. The last open-label assessment varied by participant, depending on whether a participant completed treatment through Week 256 or discontinued prior to this timepoint to transition out of clinical study settings.|Double-blind Period: Baseline to the end of the Double-blind Period (Week 20). Open-label Period: Baseline to the last Open-label assessment (up to Week 256).|"Double-blind Period: All participants in the Full Analysis Set (defined as participants who received at least 1 dose [or any portion of a dose] of sebelipase alfa or placebo).~Open-Label Period: All participants in the Extension Set (defined as participants who received at least 1 dose [or any portion of a dose] of sebelipase alfa)."|||percent change||Standard Deviation|Mean
2640209|NCT01757184|Secondary|Percentage Of Participants Achieving Aspartate Aminotransferase Normalization|"Aspartate aminotransferase (AST) normalization was defined as an abnormal baseline value (AST > the age- and gender-specific ULN provided by the central laboratory performing the assay) that becomes normal (< ULN). AST normalization was evaluated at the end of the Double-blind Period (the last Double-blind assessment) and at the end of the Open-label Period (last open-label assessment).~Baseline for the Open-label Period was defined relative to the first infusion of sebelipase alfa, which occurred at Week 0 for participants in the sebelipase alfa/sebelipase alfa group and Week 22 for participants in the placebo/sebelipase alfa group. The last open-label assessment varied by participant, depending on whether a participant completed treatment through Week 256 or discontinued prior to this timepoint to transition out of clinical study settings."|Double-blind Period: Baseline to the end of the Double-blind Period (Week 20). Open-label Period: Baseline to the last Open-label assessment (up to Week 256).|"Double-blind Period: All participants in the Full Analysis Set (defined as participants who received at least 1 dose [or any portion of a dose] of sebelipase alfa or placebo).~Open-Label Period: All participants in the Extension Set (defined as participants who received at least 1 dose [or any portion of a dose] of sebelipase alfa)."|||percentage of participants|||Number
2640210|NCT01757184|Secondary|Percent Change From Baseline In Non-high Density Lipoprotein Cholesterol (Non-HDL-C)|Relative reduction (percent change from baseline) in non-HDL-C, as assessed by laboratory measurements, was evaluated at the end of the Double-blind Period and the Open-label Period. Baseline for the Open-label Period was defined relative to the first infusion of sebelipase alfa, which occurred at Week 0 for participants in the sebelipase alfa/sebelipase alfa group and Week 22 for participants in the placebo/sebelipase alfa group. The last open-label assessment varied by participant, depending on whether a participant completed treatment through Week 256 or discontinued prior to this timepoint to transition out of clinical study settings.|Double-blind Period: Baseline to the end of the Double-blind Period (Week 20). Open-label Period: Baseline to the last Open-label assessment (up to Week 256).|"Double-blind Period: All participants in the Full Analysis Set (defined as participants who received at least 1 dose [or any portion of a dose] of sebelipase alfa or placebo).~Open-Label Period: All participants in the Extension Set (defined as participants who received at least 1 dose [or any portion of a dose] of sebelipase alfa)."|||percent change||Standard Deviation|Mean
2640211|NCT01757184|Secondary|Percent Change From Baseline In Low-density Lipoprotein Cholesterol (LDL-C)|Relative reduction (percentage change from baseline) in LDL-C, as assessed by laboratory measurements was evaluated at the end of the Double-blind Period and at the end of the Open-label Period. Baseline for the Open-label Period was defined relative to the first infusion of sebelipase alfa, which occurred at Week 0 for participants in the sebelipase alfa/sebelipase alfa group and Week 22 for participants in the placebo/sebelipase alfa group. The last open-label assessment varied by participant, depending on whether a participant completed treatment through Week 256 or discontinued prior to this timepoint to transition out of clinical study settings.|Double-blind Period: Baseline to the end of the Double-blind Period (Week 20). Open-label Period: Baseline to the last Open-label assessment (up to Week 256).|"Double-blind Period: All participants in the Full Analysis Set (defined as participants who received at least 1 dose [or any portion of a dose] of sebelipase alfa or placebo).~Open-Label Period: All participants in the Extension Set (defined as participants who received at least 1 dose [or any portion of a dose] of sebelipase alfa)."|||percent change||Standard Deviation|Mean
2640231|NCT01756456|Secondary|Change From Baseline in Best Corrected Distance Visual Acuity (BCDVA)|Best-Corrected Distance Visual Acuity (BCDVA) by means of the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart at 4 meters (13 feet). Data reported refers to week n° 8 (treatment group) and n°12/20 (FU group).|at baseline and at period 1 (8 weeks) and 2 (Follow Up period of 12 weeks, until week 20)|Safety population|||Number of ETDRS letters||Standard Deviation|Mean
2640306|NCT01755702|Secondary|Patients Global Assessment in Response to Treatment|Patients Global Assessment in Response to Treatment was assessed by a score in a scale from 0-4: 0- Poor; 1- Fair; 2- Good; 3- Very Good and 4- Excellent.|Baseline to 8 weeks|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale|||Number
2641173|NCT01748071|Secondary|Mean Heart Rate|According to the measurement of heart rate before and after intravenous injection of opioid analgesics|10 minutes after the procedure||||beats per minute||Standard Deviation|Mean
2640212|NCT01757184|Primary|Percentage Of Participants Achieving Alanine Aminotransferase Normalization|Alanine aminotransferase (ALT) normalization was defined as an abnormal baseline value (ALT > the age- and gender-specific upper limit of normal [ULN] provided by the central laboratory performing the assay) that becomes normal (< ULN). Alanine aminotransferase normalization was evaluated at the end of the Double-blind Period (the last double-blind assessment) and at the end of the Open-label Period (last open-label assessment). Baseline for the Open-label Period was defined relative to the first infusion of sebelipase alfa, which occurred at Week 0 for participants in the sebelipase alfa/sebelipase alfa group and Week 22 for participants in the placebo/sebelipase alfa group. The last open-label assessment varied by participant, depending on whether a participant completed treatment through Week 256 or discontinued prior to this timepoint to transition out of clinical study settings.|Double-blind Period: Baseline to the end of the Double-blind Period (Week 20). Open-label Period: Baseline to the last Open-label assessment (up to Week 256)|"Double-blind Period: All participants in the Full Analysis Set (defined as participants who received at least 1 dose [or any portion of a dose] of sebelipase alfa or placebo).~Open-Label Period: All participants in the Extension Set (defined as participants who received at least 1 dose [or any portion of a dose] of sebelipase alfa)."|||percentage of participants|||Number
2640213|NCT01757171|Secondary|Percent of Participants Treated With Cabazitaxel With Event Free Survival|To examine other measures of efficacy such as overall survival in all evaluable patients|From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months||||percentage of participants||95% Confidence Interval|Number
2640214|NCT01757171|Secondary|Number of Participants With Response to Cabazitaxel Across Gastric Cancer Subtypes|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months||||participants|||Number
2640215|NCT01757171|Secondary|Duration of Event Free Survival of Subjects Treated With Cabazitaxel|To examine other measures of efficacy such as overall progression free in all evaluable patients|From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months||||months||95% Confidence Interval|Median
2640216|NCT01757171|Primary|Number of Participants With Progression at the 3 Month Follow up Visit|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Results below list the number of participants who progressed at the 3 month follow up visit|3 months||||participants|||Number
2640217|NCT01756976|Primary|Washed RBC Hematocrit|The Hematocrit of the RBC shall be > 50%.|< 4 hours||||percentage of HcT||Standard Deviation|Mean
2640218|NCT01756885|Other Pre-specified|Number of Participants With Continuous Abstinence|No smoking from baseline to time-point, after a 2-week grace period.|Weeks 12, 24, and 52||||participants|||Number
2640219|NCT01756885|Secondary|Quality of Life at Week 24 and 52|The Short-Form Health Survey (SF-12) assesses Quality of Life (QOL). Scale range from 12 - 47. Higher score indicates worse quality of life.|Weeks 24 & 52|Difference in number of participants at Weeks 24 and 52 are due to attrition.|||score on a scale||Standard Deviation|Mean
2640220|NCT01756885|Primary|7-day CO-verified Tobacco Abstinence|Number of Participants with Verified 7 Day Tobacco Abstinence.|Weeks 24 & 52||||participants|||Number
2640221|NCT01756846|Other Pre-specified|Pre-specified Subgroup Analyses|"To assess whether the effectiveness and/or safety of using the HEART (history, ecg, age, risk factors, troponin) score (scale 0-10, with higher scores meaning a higher risk on MACEs) is different between specific patient populations, the following pre-specified subgroup analyses will be performed: Age: below and above 62 years of age (median), Gender: Men vs Women, Diabetics vs non-diabetics, Ethnicity: Caucasian vs. other ethnicity.~RESULTS: None of the pre-specified subgroup analyses of women, elderly patients, and diabetic patients showed a statistically significantly different effect of HEART care with respect to incidence of MACEs. Ethnicity was unfortunately not possible to analyse due to too much missing data.~NB. I am currently not working in the organisation which has the data, and this will not be possible the coming period. Therefore, I cannot provide correct numbers currently on these subgroup analyses, only conclusions. I am sorry for this inconvenience."|6 weeks||2019-01-31|01/2019||||
2640222|NCT01756846|Other Pre-specified|Gender-related Differences in Risk for MACE|with a women-specific questionnaire, we hope to identify risk factors specific for women (pregnancy diabetes/hypertension, Poly Cystic Ovarial Syndrome (PCOS), etc)|3 months|||||||
2640223|NCT01756846|Secondary|Cost-effectiveness (Costs, QoL, QALYs)|Information on quality of life (QoL) and costs was collected in 5 of the 9 hospitals. Costs for health care resource use were calculated based on Dutch guidelines and cost tables for hospitals. Different costs were used for academic and general hospitals, and costs were adjusted for inflation by using the consumer price indices provided by Statistics Netherlands. For each patient the costs were calculated based on the observed number and type of health care resources used and the type of hospital (academic/general). Data on resource use were collected for each patient in the 5 hospitals; no data were missing. QoL was derived from the EQ-5D-3L questionnaire, consisting of 5 questions (dimensions) with 3 answers each, from which QoL scores (utility values, 0-1, the higher the better) can be directly derived. Quality-adjusted life-years (scale 0-100, higher the better) were calculated over a period of 3 months, based on the estimated QoL values at 0 weeks, 2 weeks, and 3 months.|3 months|Cost-effectiveness analysis was performed in 5 of 9 hospitals|||years||95% Confidence Interval|Mean
2640224|NCT01756846|Primary|MACE (Major Adverse Cardiac Events)|occurrence of major adverse cardiac events (MACE, i.e. acute myocardial infarction (AMI), Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG) or death) within 6 weeks after presentation|6 weeks||||Participants|||Count of Participants
2640225|NCT01756586|Primary|Increase in the Duration of Block||3 days|Did not have resources to follow up with the subjects after the surgery. The study was terminated early.||||||
2640226|NCT01756573|Primary|Analgesia Duration||72 hrs|study terminated prematurely due to lack of resources and participation- no data collected for Outcome measures and no analysis done||||||
2640232|NCT01756456|Secondary|Change From Baseline in Visual Analogue Scale (VAS) for Ocular Tolerability|"Ocular tolerability was recorded by the patient on a VAS scale from 0 to 100 mm, where a higher VAS score indicates worse ocular symptoms (0 means no symptoms and 100 means the worst possible discomfort). The overall VAS score for ocular tolerability was calculated as the mean of the individual VAS scores for the 7 different symptoms (foreign body sensation, burning/stinging, itching, ocular pain, sticky feeling, blurred vision and photophobia).~Results are below reported as per symptoms at week 8 (for treatment period) and week 20 (for Follow Up period)."|at baseline and at weeks 8 and 20|Safety population|||VAS score||Standard Deviation|Mean
2640233|NCT01756456|Secondary|Percentage of Patients Experiencing a Different Level of Efficacy at 4 and 8 Weeks|Global evaluation of efficacy as assessed by the Investigator at 4 and 8 weeks. The different level of efficacy were: very good; good; moderate; poor; non-evaluable.|at week 4 and 8|ITT population|||percentage of subjects|||Number
2640234|NCT01756456|Secondary|Percentage of Patients Achieving Complete Healing of the PED or Corneal Ulcer by Week 8/16 That Remain Healed at Weeks 20/28, 32/40, 44/52, 56/64|Percentage of patients achieving complete healing of the PED or corneal ulcer by Week 8/16 that remain healed (ie, no recurrence of the PED and/or corneal ulcer) at Weeks 20/28, 32/40, 44/52, 56/64|at week 20/28, 32/40, 44/52, and 56/64|ITT population|||percentage of subjects|||Number
2640235|NCT01756456|Secondary|Percentage of Patients Experiencing Deterioration in Stage 2 or 3 NK|Percentage of patients experiencing deterioration (increase in lesion size ≥ 1mm, decrease in BCDVA by >5 ETDRS letters, progression in lesion depth to corneal melting or perforation, onset of infection) in stage 2 or 3 NK from baseline to Week 4, 6, and 8.|from baseline to Week 4, 6, and 8.|ITT population|||percentage of subjects|||Number
2640236|NCT01756456|Secondary|Percentage of Patients That Achieve an Improvement in Corneal Sensitivity|Percentage of patients that achieve an improvement in corneal sensitivity as measured by the Cochet-Bonnet aesthesiometer|at 4, 6 and 8 weeks.|ITT population|||percentage of subjects|||Number
2640237|NCT01756456|Secondary|Mean Change in Best Corrected Distance Visual Acuity (BCDVA)|Mean changes in Best-Corrected Distance Visual Acuity (BCDVA) from baseline to Week 8 are calculated as Least Square means. BCDVA consists of letters read at 4 meters only. Patients are scored by how many letters could be correctly identified. Therefore the higher the number of letters, the higher the visual acuity.|At screening and at week 8|ITT population|||LogMAR||Standard Error|Least Squares Mean
2640238|NCT01756456|Secondary|Percentage of Patients Experiencing Complete Corneal Clearing|"Complete corneal clearing (grade 0 on the modified Oxford scale) at 4, 6 and 8 weeks.~A patient was considered to have achieved complete corneal clearing if he/she had a Modified Oxford Scale recorded as Grade 0.~The scale has the following grades: 0-1-2-3-4-5, where 5 represents the worst outcome value and 0 the best outcome value."|at 4, 6 and 8 weeks after start of the treatment|ITT population|||percentage of subjects|||Number
2640239|NCT01756456|Secondary|Percentage of Patients Experiencing Complete Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer|"Complete healing of the PED or corneal ulcer at 6 and 8 weeks measured by both the central reading center and Investigator.~Complete healing was defined as the greatest diameter of the corneal fluorescein staining in the area of the PED or corneal ulcer being less than 0.5 mm.~This outcome was analyzed after 6 and 8 weeks of treatment only for the Phase II segment of the study. That's why the Phase I groups/arms are not included in this analysis."|at 6 and 8 weeks after start of the treatment|Phase II patients who achieved complete healing at Week 4 (last observation carried forward - LOCF) as determined by the reading center (ITT population).|||percentage of subjects|||Number
2640240|NCT01756456|Secondary|Percentage of Patients Experiencing Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer|"Complete healing of the PED or corneal ulcer at 4 weeks as defined by the Investigator. The complete healing was defined as the greatest diameter of the corneal fluorescein staining in the area of the PED or corneal ulcer, being less than 0.5 mm at the Week 4 visit.~This secondary outcome was analyzed after 4 weeks of treatment only for the Phase II segment of the study. That's why the Phase I groups/arms are not included in this analysis."|at 4 weeks of study treatment.|Phase II patients who achieved complete healing at Week 4 (last observation carried forward - LOCF) as determined by the reading center (ITT population).|||percentage of subjects|||Number
2640241|NCT01756456|Primary|Percentage of Patients Achieving Healing of the Persistent Epithelial Defect (PED) or Corneal Ulcer|"Complete healing of the PED or corneal ulcer was determined by corneal fluorescein staining at 4 weeks as defined by the reading center evaluating the clinical pictures.~Complete healing was defined as the greatest diameter of the corneal fluorescein staining in the area of the PED or corneal ulcer being less than 0.5 mm at the Week 4 visit.~The primary efficacy variable was analyzed after 4 weeks of treatment only for the Phase II segment of the study. That's why the Phase I groups/arms are not included in this analysis."|at 4 weeks of treatment|Phase II patients who achieved complete healing at Week 4 (last observation carried forward - LOCF) as determined by the reading center (ITT population).|||percentage of subjects|||Number
2640242|NCT01756391|Primary|Maximum Symptom Days/14 Days|"Largest value among the following:~Number of days with wheezing, tightness in the chest, or cough Number of nights with disturbed sleep as a result of asthma Number of days on which the child had to slow down or discontinue play activities because of asthma"|14 days|Those with appropriate follow up and school/home allergen exposure data and allergy sensitization data|||days||Standard Deviation|Mean
2640243|NCT01756391|Secondary|Exhaled Nitric Oxide Levels||12 months|||||||
2640244|NCT01756391|Secondary|Percent Change in FEV1 After Short-acting Beta Agonist||12 months|||||||
2640245|NCT01756391|Secondary|FEV1 Percent Predicted||12 months|||||||
2640246|NCT01756391|Secondary|FEV1/FVC||12 months|||||||
2640247|NCT01756391|Secondary|Prednisone Bursts||12 months|||||||
2640248|NCT01756391|Secondary|Unscheduled Physician/Health Care Visits||12 months|||||||
2640249|NCT01756391|Secondary|Emergency Department Visits||12 months|||||||
2640250|NCT01756391|Secondary|Emergency Department Visits||12 months|||||||
2640251|NCT01756391|Secondary|Number of Hospitalizations||12 months|||||||
2640252|NCT01756391|Secondary|Nights of Wakening Due to Asthma Symptoms||12 months|||||||
2640253|NCT01756391|Secondary|Days of Cough Without an Upper Respiratory Infection||12 months|||||||
2640254|NCT01756391|Secondary|Days of Exercise-induced Symptoms||12 months|||||||
2640258|NCT01756300|Secondary|Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure|This endpoint is defined as Incidence of subjects achieving at least 10 mmHg systolic blood pressure reduction from Baseline at 1, 3, 6, and 12 month post-procedure|At 1, 3, 6, and 12 month post-procedure|The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. .|||percentage of participants|||Number
2640259|NCT01756300|Secondary|Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure|This endpoint is defined as incidence of subjects achieving target systolic blood pressure at 1, 3, 6, and 12 month post-procedure. Target systolic blood pressure is defined as less than 140 mmHg (and less than 130 mmHg for Type II Diabetics).|At 1, 3, 6, and 12 month post-procedure|The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. .|||percentage of participants|||Number
2640260|NCT01756300|Secondary|Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure|This secondary effectiveness endpoint is defined as change in 24-hour ABPM systolic blood pressure and diastolic blood pressure from baseline to 3, 6 and 12 months post procedure. The blood pressures were measured using the 24-hour Ambulatory Blood Pressure Monitoring system. Reported values are the arithmetic mean of collected blood pressure values over 24 hours. Negative values represent reduction from baseline.|From baseline to 3, 6 and 12 months post procedure|The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. .|||mmHg||Standard Deviation|Mean
2640261|NCT01756300|Secondary|Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure|This secondary effectiveness endpoint is defined as actual and change in office systolic blood pressure and diastolic blood pressure from baseline to 1 ,3, 6 and 12 months post procedure. Negative values represent reduction from baseline.|From baseline to 1 ,3, 6 and 12 months post procedure|The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and radiofrequency (RF) energy is successfully applied in at least one artery. .|||mmHg||Standard Deviation|Mean
2640262|NCT01756300|Secondary|Subjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure|These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); periprocedural renal artery dissection or perforation requiring intervention, serious arterial access site related complications requiring intervention or prolonging hospitalization; ≥25% reduction between baseline and 12 months in renal function measured by the estimated Glomerular Filtration Rate (eGFR), as well as composite of major adverse cardiovascular and/or renal events.|12 months post-procedure|The Safety Analysis population, which consists of all enrolled subjects who have undergone insertion of the study ablation catheter.|||percentage of participants|||Number
2640263|NCT01756300|Primary|The Incidence of Major Cardiovascular and/or Renal Adverse Events Related to the Renal Denervation Procedure That Occurred Within 30 Days Post-procedure.|The major adverse events include Acute myocardial infarction, Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death, New-onset heart failure, Stroke, Aortic or lower limb, revascularization procedure, Lower limb amputation, Beginning dialysis, Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit, Hospitalization for atrial fibrillation.|30 days post-procedure|The Safety Analysis population, which consists of all enrolled subjects who have undergone insertion of the study ablation catheter.|||percentage of participants|||Number
2640264|NCT01756274|Other Pre-specified|Number of Blood Samples From Babies in the Neonatal Intensive Care Unit (NICU) That Produced Meter Results Beyond What Random Chance Would Predict (i.e., Outside 95% Limits for Studentized Residuals)|To evaluate how the meter systems perform with blood samples drawn in the Neonatal Intensive Care Unit, the number of blood samples that produced unusual meter results out of the total number of blood samples that came from babies in Neonatal Intensive Care was reported. Studentized residuals were used to measure the degree to which meter BG results departed from what would be expected using a linear model. (This analysis is not related to BGM accuracy status, which has already been reported.)|30 minutes|Of 217 'left-over' blood samples, 211(217-6) were included in data analysis and, of these, thirty (30) blood samples were obtained from babies in the Neonatal Intensive Care Unit (NICU).|||BLOOD SAMPLES|BLOOD SAMPLES From Babies in the NICU||Number
2640265|NCT01756274|Other Pre-specified|Number of Blood Samples From Babies Less Than 24 Hours Old That Produced Meter Results Beyond What Random Chance Would Predict (i.e. Outside 95% Limits for Studentized Residuals)|To evaluate the effect of neonatal age on the meter systems' performances, the number of blood samples that produced unusual meter results out of the total number of blood samples that came from babies less than 24 hours old was reported. Studentized residuals were used to measure the degree to which meter BG results departed from what would be expected using a linear model. (This analysis is not related to BGM accuracy status, which has already been reported.)|30 minutes|Of 217 'left-over' blood samples, 211(217-6) were included in data analysis. Of these, twenty five (25) blood samples were obtained from babies that were less than 24 hours old.|||BLOOD SAMPLES|BLOOD SAMPLES From Babies <24 hours old||Number
2640307|NCT01755702|Secondary|Headache Severity|"Headache severity (scores) at 15, 30, 45, 60, 90, 120, and 240 minutes were calculated as change (difference) from baseline of pain intensity at each time point.~Pain intensity was measured by numerical rating scale which is a horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain."|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2640266|NCT01756274|Secondary|Percent of BG Results (Per Population) Within +/-15 mg/dL (<100 mg/dL)and Within +/-15% (>=100 mg/dL) of the Reference Instrument BG Value|Laboratory professionals tested the BG concentration of 'left-over samples' using plasma referenced Blood Glucose Monitoring Systems. BGMS results were compared with capillary plasma BG results obtained with a Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).|30 minutes|Each subject could contribute up to 2 blood samples. Of 217 blood samples 211(217-6) were included in data analysis. Two samples could not be used because they had been taken from sources that had not been specified in the protocol. Four samples had no reference method results due to laboratory errors.|||percentage of BLOOD GLUCOSE RESULTS|BLOOD SAMPLES||Number
2640267|NCT01756274|Primary|Percent of Blood Glucose Results Within +/-15 mg/dL(<75 mg/dL) and Within +/-20% (>=75 mg/dL) of the Reference Instrument BG Value|Laboratory professionals tested the BG concentration of 'left-over samples' using plasma referenced Blood Glucose Monitoring Systems. BGMS results were compared with capillary plasma BG results obtained with a Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).|30 minutes|Each subject could contribute up to 2 blood samples. Of 217 blood samples 211(217-6) were included in data analysis. Two samples could not be used because they had been taken from sources that had not been specified in the protocol. Four samples had no reference method results due to laboratory errors.|||percentage of Blood Glucose Results|Blood Samples||Number
2640268|NCT01756235|Secondary|Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Occupation|The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.|Month 0 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
2640269|NCT01756235|Secondary|Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Education|The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.|Month 0 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
2640270|NCT01756235|Secondary|Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Gender|The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.|Month 0 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
2640271|NCT01756235|Secondary|Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Age Categories|The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.|Month 0 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
2640272|NCT01756235|Secondary|Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores|The SQUASH and its subscores are instruments to measure the physical activity level, whereas the HAQ-DI measures physical functioning. In order to evaluate the relationship between physical function and physical activity (as measured by the both scales), Pearson correlation coefficients were calculated for the SQUASH scores and the HAQ-DI. A decrease in physical functioning is likely to prohibit physical activity.|Month 0 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||Correlation coeficient|||Number
2640273|NCT01756235|Secondary|Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores|The SQUASH and its subscores are instruments to measure the physical activity level, whereas the DAS28 measures disease activity. In order to evaluate the relationship between physical function and disease activity (as measured by the two scales), Pearson correlation coefficients were calculated for the SQUASH scores and the DAS28. A decrease in physical functioning is likely to be connected to stronger disease activity.|Month 0 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||Correlation coeficient|||Number
2640284|NCT01756235|Secondary|Mean Change From Baseline in Total Physical Activity SQUASH Score|The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.|Month 3, Month 6 and Month 9|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
2676188|NCT01440569|Secondary|Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48 (Snapshot Analysis)||Week 48|Full Analysis Set|||percentage of participants|||Number
2640274|NCT01756235|Secondary|Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores range from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from baseline in the overall score indicates improvement.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
2640275|NCT01756235|Secondary|Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS|This outcome analyses the quantitative SQUASH score and individual SQUASH scores by DAS28 categories. The quantitative SQUASH score (ranging from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), leisure time activities (SQUASH-B), household activities (SQUASH-C) and activity at work and school (SQUASH-D). The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. DAS28 categories being assessed are remission (defined as DAS28 of less than 2.6) and LDAS (defined as DAS28 of less than 3.2).The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
2640276|NCT01756235|Secondary|Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS|This outcome analyses the quantitative SQUASH score and individual SQUASH scores by DAS28 categories. The quantitative SQUASH score (ranging from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), leisure time activities (SQUASH-B), household activities (SQUASH-C) and activity at work and school (SQUASH-D). The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. DAS28 categories being assessed are remission (defined as DAS28 of less than 2.6) and LDAS (defined as DAS28 of less than 3.2).The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
2640277|NCT01756235|Secondary|Percentage of Participants With Low Disease Activity State (LDAS, DAS28<3.2)|LDAS is defined as DAS28 of less than 3.2. The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||percentage of participants|||Number
2640278|NCT01756235|Secondary|Percentage of Participants in Clinical Disease Remission (DAS28<2.6)|Remission is defined as DAS28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.|Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||percentage of participants|||Number
2640279|NCT01756235|Secondary|Mean Change From Baseline in Disease Activity Index - 28 Joints (DAS28) Score|The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein, and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
2640280|NCT01756235|Secondary|Mean Change From Baseline in SQUASH-D Scores|SQUASH subscores capture physical activity. SQUASH-D subscore captures activity at work and school, with scores ranging from 0 to 3402.000. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
2640281|NCT01756235|Secondary|Mean Change From Baseline in SQUASH-C Scores|SQUASH subscores capture physical activity. SQUASH-C subscore captures house-hold activities, with scores ranging from 0 to 3402.000. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
2640282|NCT01756235|Secondary|Mean Change From Baseline in SQUASH-B Scores|SQUASH subscores capture physical activity. SQUASH-B subscore captures leisure time activities, with scores ranging from 0 to 6123.600. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.|Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
2640285|NCT01756235|Primary|Mean Change From Baseline in Total Physical Activity Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) Score|The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.|Month 0 (baseline) and Month 12 (Last Observation Carried Forward (LOCF))|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
2640286|NCT01756209|Primary|Pain-relief|"The primary endpoint was when pain-relief took place and pain intensity differences from baseline (0 hour) to 3 hours after drug treatment. This measurement was defined as the AUC for the sum of the 2 measurements (pain relief and pain intensity difference) at each time point from 0 to 3 hours.~Pain was measured using the vas analogue scale (range 0-10, where 0 = no pain (score 0) and 100 mm = worst pain (score 10)"|3 and 18 months||||units on a scale*hr||Standard Deviation|Mean
2640287|NCT01756157|Secondary|Number of Angioedema Attacks Requiring Acute Treatment During the Treatment Period|Angioedema attack was defined as the participant-reported indication of symptoms or signs such as swelling or pain at any location following a report of no swelling or pain on the previous day. Manifestations of an attack that progress from one site to another, prior to complete resolution, was considered a single attack. Attacks that began to regress and then worsened before complete resolution was also considered one attack. Participants who were dosed but did not have any attacks in the period were assigned a value of zero. The number of attacks was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|ITT-E population|||angioedema attacks||Standard Deviation|Mean
2640288|NCT01756157|Secondary|Cumulative Symptomatic Days During the Treatment Period|Cumulative symptomatic days was defined as the sum of the symptomatic days of each angioedema attack reported during the treatment period. Participants who were dosed but did not have any attacks in the period were assigned a value of zero. Cumulative symptomatic days was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|ITT-E population|||days||Standard Deviation|Mean
2640289|NCT01756157|Secondary|Cumulative Daily-severity During the Treatment Period|"Cumulative Daily-severity score was the sum of the severity scores recorded for every day of reported symptoms during the treatment period.~Severity scores were recorded as None=0, Mild=1, Moderate=2, and Severe=3. None: no angioedema attack symptom; Mild: the angioedema attack symptom was noticeable to the participant but was easily tolerated and did not interfere with routine activities; Moderate: the angioedema attack symptom interfered with work/school or the ability to participate in family life and social activities; Severe: the angioedema attack symptom significantly limited the participant's ability to attend work/school or participate in family life and social activities.~Cumulative daily severity was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.~The scores ranged from 0 to 168 and higher scores represent worse symptoms."|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|ITT-E population|||Score on a scale||Standard Deviation|Mean
2640290|NCT01756157|Secondary|Cumulative Attack-severity During the Treatment Period|"Cumulative Attack-severity score was the sum of maximum symptom severity recorded for each angioedema attack, determined on the last day of symptoms and recorded as None=0, Mild=1, Moderate=2, and Severe=3 and summing over the unique attacks, yields a Cumulative Attack-severity score.~None: no angioedema attack symptom; Mild: the angioedema attack symptom was noticeable to the participant but was easily tolerated and did not interfere with routine activities; Moderate: the angioedema attack symptom interfered with work/school or the ability to participate in family life and social activities; Severe: the angioedema attack symptom significantly limited the participant's ability to attend work/school or participate in family life and social activities.~Cumulative attack-severity was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.~The scores ranged from 0 to 168 and higher scores represent worse symptoms."|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|ITT-E population|||Score on a scale||Standard Deviation|Mean
2640291|NCT01756157|Primary|Normalized Number of Angioedema Attacks During the Treatment Period|Angioedema attack was defined as the participant-reported indication of symptoms or signs such as swelling or pain at any location following a report of no swelling or pain on the previous day. Manifestations of an attack that progress from one site to another, prior to complete resolution, was considered a single attack. Attacks that began to regress and then worsened before complete resolution was also considered one attack. Participants who were dosed but did not have any attacks in the period were assigned a value of zero. The number of attacks was normalized for the number of days participants participated in a given period and expressed as the monthly frequency.|From Visit 1 (Week 1) up to Visit 16 (Week 8) during each treatment period|Intent-to-treat efficacy (ITT-E) population included all participants who completed both randomized treatment periods and fulfilled a priori defined evaluability criteria.|||angioedema attacks||95% Confidence Interval|Mean
2640292|NCT01756079|Primary|Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication|Adverse events were monitored during the Lead-in and Treatment Periods|Up to 48 weeks (Lead-in and Treatment Periods)|Safety Analysis Set 2 included all participants who received boceprevir during the Treatment Period|||Percentage of participants|||Number
2640293|NCT01756079|Primary|Percentage of Participants With One or More Adverse Events|Adverse events were monitored during the Lead-in and Treatment Periods|Up to 48 weeks (Lead-in and Treatment Periods)|Safety Analysis Set 2 included all participants who received boceprevir during the Treatment Period|||Percentage of participants|||Number
2640294|NCT01756079|Primary|Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)|Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using a polymerase chain reaction assay. SVR24 was defined as HCV RNA less than the Limit of Quantification (<25 International Units (IU)/mL) 24 weeks after the end of the Treatment Period.|Week 72 (24 weeks after end of treatment)|The Intent to Treat population included all participants who received at least 1 administration of boceprevir during the Treatment Period.|||Percentage of participants||95% Confidence Interval|Number
2640295|NCT01756053|Primary|Change in Abstinence-induced Cognitive Deficits (N-Back Correct Response Time)|"We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence.~To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 & 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo.~Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds).~All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic.~NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)"|Baseline (Day 0) and Test Day (Days 6 & 37)|Only participants completing both study periods (n=13) were included in the analyses.|||Milliseconds||Standard Deviation|Mean
2640296|NCT01756053|Secondary|Effects of ABT-089 on Days of Biochemically-confirmed Abstinence|Daily smoking rate will be assessed at each in-person visit using the Timeline Follow-Back assessment. Abstinence will be confirmed by exhaled carbon monoxide levels during a ~4-day monitored abstinence phase within each period.|Days 7, 8, 9, 10, 38, 39, 40, & 41|Only participants completing both study periods (n=13) were included in the analyses.|||Days of abstinence||Standard Deviation|Mean
2640297|NCT01756053|Secondary|Effects of ABT-089 on Cigarette Ratings|"Cigarette evaluation scale: The Cigarette Evaluation Scale (CES), developed to assess subjective effects of smoking, is an 11-item Likert-format measure. Questions include items for nausea and dizziness, craving relief, and enjoyment of airway sensations. Items are rated on a scale from 1 (Not at all) to 7 (Extremely); a summary score is calculated as the mean of all responses (range: 1-7). Higher scores indicate stronger subjective effects of smoking."|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.|||Scores on a scale||Standard Deviation|Mean
2640298|NCT01756053|Secondary|Effects of ABT-089 on Attention-deficit and Hyperactive Symptoms|ADHD symptoms: The 27-item BAARS-IV scale was used to assess current attention-deficit and hyperactive symptoms. Participant rated the intensity of their symptoms using the following scale: 1= never or rarely, 2 = sometimes, 3 = often, or 4 = very often. A total score was calculated as the sum of the individual items (range: 27-108). Higher scores indicate more frequent ADHD symptoms.|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.|||Scores on a scale||Standard Deviation|Mean
2640299|NCT01756053|Secondary|Effects of ABT-089 on Smoking Urges/Craving|QSU-B: The 10-item brief QSU (QSU-B) questionnaire was used to assess smoking urges. Each item is rated on a 7-point scale (1 = strongly disagree, 7 = strongly agree). A total score is calculated as the sum of the individual items (range: 10-70). Higher scores indicate more severe urges to smoke.|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.|||Scores on a scale||Standard Deviation|Mean
2640300|NCT01756053|Secondary|Effects of ABT-089 on Withdrawal Symptoms|"MNWS: The Minnesota Nicotine Withdrawal Scale - Revised version captures the current state of nicotine withdrawal. The scale assesses 15 items of nicotine withdrawal (including 7 DSM-IV items) such as: dysphoria or depressed mood, insomnia, irritability/frustration/anger, anxiety, difficulty concentrating, restlessness, and increased appetite/weight gain. Subjects will rate the intensity of their symptoms on the following scale: 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe. A withdrawal discomfort score was calculated as the sum of the first 9 items (possible range: 0-36) and is a well-validated measure of nicotine withdrawal; a higher score indicates more severe withdrawal."|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.|||Scores on a scale||Standard Deviation|Mean
2640301|NCT01756053|Secondary|Effects of ABT-089 on Mood|PANAS: The Positive and Negative Affect Schedule (PANAS), a 20-item Likert-format self-report measure, was used to assess Positive Affect (PA; 10 items, e.g., enthusiastic, strong) and Negative Affect (NA; 10 items, e.g., distressed, upset), two dominant and generally orthogonal dimensions of affect. Scores for the 10 items on each subscale were summed to create summary scores (range: 10-50); higher scores indicate greater intensity of mood (i.e., more positive or more negative affect). Higher ratings of positive affect and lower ratings of negative affect are considered better outcomes.|Days 6 and 37|Only participants completing both study periods (n=13) were included in the analyses.|||Scores on a scale||Standard Deviation|Mean
2640302|NCT01756053|Primary|Change in Abstinence-induced Cognitive Deficits (N-Back Accuracy)|"We will assess whether ABT-089 ameliorates the cognitive deficits due to smoking abstinence.~To assess, all subjects will complete a computerized N-Back task during the Testing Day Session (Days 6 & 37) in each study medication period. Each Testing Day session occurs after 24 hours of abstinence from smoking. During one study medication period, subjects will take active ABT-089; during the other period, subjects will take a matched placebo.~Each of the task conditions (0-, 1-, 2-, and 3-back) will be administered in a pseudorandomized counterbalanced order. Each difficulty level will consist of one block of 50 trials, preceded by a practice block of 20 trials. The primary dependent variables for this task are total number of correct responses (out of 60) and reaction time (milliseconds).~All computerized neurocognitive tasks are completed in a quiet, standardized environment in our clinic.~NOTE: Each PPT completes 1 Baseline (no tx.) and 2 Testing Days (ABT/Placebo)"|Baseline (Day 0) and Test Day (Days 6 & 37)|Only participants completing both study periods (n=13) were included in the analyses.|||Number of correct responses (out of 60)||Standard Deviation|Mean
2640303|NCT01755949|Secondary|Time Course of C-reactive Protein Levels|Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay.|baseline, day 3, day 7, day 14, day 28|Not all subjects had sample available at all timepoints to measure C-reactive protein levels. Sample was either not collected or insufficient volume to run assay.|||ng/ml||Standard Deviation|Mean
2640304|NCT01755949|Secondary|Number of Subjects With Atrial Fibrillation|All subjects will have 12 lead ECG on day 28 to measure the number of subjects with normal sinus rhythm and atrial fibrillation.|day 28||||Participants|||Count of Participants
2640305|NCT01755949|Primary|Change in C-reactive Protein|Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay.|baseline, day 28|Not all subjects had sample available at all timepoints to measure C-reactive protein levels. Sample was either not collected or insufficient volume to run assay.|||ng/mL||Standard Deviation|Mean
2640308|NCT01755702|Secondary|Number of Participants With Complete Headache Relief|Number of headaches resolved at 1 and 2 hours before any rescue medication was calculated as number of participants with complete pain relief and headache severity of 'no headache' over total number of participants. These calculations were based on one headache per treatment per subject.|Baseline to 2 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.|||Participants|||Number
2640309|NCT01755702|Secondary|Time to Rescue Medication|Time to rescue medication was evaluated.|Baseline to 6 hours post dose|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.|||minutes||Full Range|Median
2640310|NCT01755702|Secondary|Sum of TOTPAR and SPID (SPRID)|"Area under the time-response curve for change in headache intensity and headache relief (SPRID) at 60, 90, 120 and 240 minutes, was calculated as sum of TOTPAR and SPID:~SPRIDt = TOTPARt + SPIDt~TOTPAR was calculated as sum of the products of pain relief score. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.~SPID was calculated as the sum of headache intensity differences between baseline and at each time point. It was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain."|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2640311|NCT01755702|Secondary|Sum of Pain Intensity Difference (SPID)|"Sum of pain intensity difference (SPID) at 60, 90, 120 and 240 minutes - calculated as the sum of headache intensity differences between the baseline pain intensity score and pain intensity score at each timepoint.~Pain intensity was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.~It was calculated using the following formula; SPID t = ΣPID x (time t - time t-1), where PID = PI (baseline) - PI t and PI = pain intensity."|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2640312|NCT01755702|Secondary|Total Pain Relief (TOTPAR)|"TOTPAR was calculated as sum of the products of pain relief score at time interval at 0-60 minutes, 60-90 minutes, 90-120 minutes and 120-240 minutes. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.~It was calculated using the following formula.~TOTPAR t = Σ(Rt x (time t - time t-1)), where Rt = pain relief score at time t; time t = time t in hours; time t-1 = time at previous time-point."|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2640313|NCT01755702|Secondary|Headache Relief Scores|Pain relief scores were measured on a scale from 0-4: 0- No pain relief; 1- Perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief and 4- Complete relief.|Baseline to 4 hours|ITT population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2640314|NCT01755702|Primary|Time to First Perceptible Headache Relief|Time to first perceptible pain relief, calculated as time when partcipant selected 'a little' pain relief in the electronic pad minus the time of treatment. If this time was not available in the electronic pad then the earliest time corresponding to a pain relief score 1 or greater was recorded as time to 'a little' pain relief.|Baseline to 6 hours|Intention to treat (ITT) population: All randomized participants who received at least one study medication and who had at least one post-baseline efficacy assessment.|||minutes||Full Range|Median
2640315|NCT01755689|Secondary|Number of Subjects With New Onset Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|During the entire study period (from Month 0 to Month 8)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Participants|||Count of Participants
2640316|NCT01755689|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs)|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (from Month 0 to Month 8)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Participants|||Count of Participants
2640317|NCT01755689|Secondary|Number of Subjects With Serious Adverse Events SAE(s)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 to Month 8)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Participants|||Count of Participants
2640318|NCT01755689|Secondary|Number of Subjects With Unsolicited Adverse Events AE(s)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 31-day (Days 0-30) period following vaccination with Nimenrix, Boostrix or the first dose of Cervarix|The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Participants|||Count of Participants
2640339|NCT01755637|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Albendazole|Tmax was time at which Cmax of Albendazole was reached.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Participants were excluded where the baseline concentration was greater than 5% of Cmax.|||hr||Full Range|Median
2640319|NCT01755689|Secondary|Number of Subjects Reporting Solicited General Symptoms|"Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)] and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Some groups do not have results for Dose 2 because solicited local symptoms were not collected for these subjects at the Dose 2 timepoint."|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented, who filled in their symptom sheets.|||Participants|||Count of Participants
2640320|NCT01755689|Secondary|Number of Subjects Reporting Solicited Local Symptoms|"Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Symptoms were presented by vaccination site. Some groups do not have results for Dose 2 because solicited local symptoms were not collected for these subjects at the Dose 2 timepoint."|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented, who filled in their symptom sheets.|||Participants|||Count of Participants
2640321|NCT01755689|Secondary|Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value|The antibody concentrations were calculated as GMCs and expressed as IU/mL. Anti-PT assay cut-off=2.693 IU/mL, anti-FHA assay cut-off=2.046 IU/mL, anti-PRN assay cut-off=2.187 IU/mL.|Prior to and one month after Boostrix vaccination (Months 0 and 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.|||Participants|||Count of Participants
2640322|NCT01755689|Secondary|Anti-D and Anti-T Antibody Concentrations|The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).|Prior to and one month after Boostrix vaccination (Months 0 and 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.|||IU/mL||95% Confidence Interval|Geometric Mean
2640323|NCT01755689|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL|The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).|Prior to and one month after Boostrix vaccination (Month 0 and Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.|||Participants|||Count of Participants
2640324|NCT01755689|Secondary|Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Antibodies|"Booster responses to the PT, FHA and PRN antigens were defined as:~For initially seronegative subjects (antibody concentrations: < 2.046 IU/ml for anti-FHA, < 2.187 IU/ml for anti-PRN, < 2.693 IU/ml for anti-PT), antibody concentration ≥ 4*cut_off IU/ml at Month 1 post-vaccination;~For initially seropositive subjects (antibody concentrations: ≥ 2.046 IU/ml for anti-FHA, ≥ 2.187 IU/ml for anti-PRN, ≥ 2.693 IU/ml for anti-PT) with pre-vaccination antibody concentration < 4*cut_off IU/ml : antibody concentration at Month 1 ≥ 4 fold the pre-vaccination antibody concentration;~For initially seropositive subjects (antibody concentrations: ≥ 2.046 IU/ml for anti-FHA, ≥ 2.187 IU/ml for anti-PRN, ≥ 2.693 IU/ml for anti-PT) with pre-vaccination antibody concentration ≥ 4*cut_off IU/ml : antibody concentration at Month 1 ≥ 2 fold the pre-vaccination antibody concentration."|At one month after Boostrix vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.|||Participants|||Count of Participants
2640325|NCT01755689|Secondary|Anti-HPV-16 and Anti-HPV-18 Concentrations|The antibody concentrations were calculated as GMCs and expressed as EU/mL, only for the Nimenrix+Cervarix (1,2,7-Month) Group.|Prior to and one month after the third dose of Cervarix (Months 0 and 8)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination from the Nimenrix+Cervarix (1,2,7-Month) Group.|||EU/mL||95% Confidence Interval|Geometric Mean
2640326|NCT01755689|Secondary|Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies|Seroconversion rate is defined as the appearance of antibodies (i.e. titers greater than or equal to the cut-off value) in the serum of subjects who are seronegative before vaccination. The antibody concentrations were calculated as GMCs and expressed as EU/mL.|Prior to and one month after the third dose of Cervarix (Month 0 and Month 7/Month 8)|The analysis was performed on the ATP cohort for immunogenicity after Cervarix vaccination, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination.|||Participants|||Count of Participants
2640327|NCT01755689|Secondary|Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL|The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL).|Prior to the first dose and one month after the third dose of Cervarix [Month 0 and Month 7/Month 8 in Nimenrix+Cervarix (1,2,7-Month) Group]|The analysis was performed on the ATP cohort for immunogenicity after Cervarix vaccination, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination.|||Participants|||Count of Participants
2640328|NCT01755689|Secondary|Anti-T Antibody Concentrations|The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). This analysis was only performed for the Nimenrix+Cervarix (1,2,7-Month) Group.|Prior to and one month after vaccination with Nimenrix (Months 0 and 1)|The analysis was performed on the ATP cohort for immunogenicity,which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after Nimenrix vaccination,only for Nimenrix+Cervarix (1,2,7-Month) Group.|||IU/mL||95% Confidence Interval|Geometric Mean
2640329|NCT01755689|Secondary|Number of Subjects With Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥ 1.0 IU/mL|The antibody concentrations were tabulated as GMCs and expressed as IU/mL, only for the Nimenrix+Cervarix (1,2,7-Month) Group.|Prior to and one month after vaccination with Nimenrix (Months 0 and 1)|The analysis was performed on the ATP cohort for immunogenicity,which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after Nimenrix vaccination,only for Nimenrix+Cervarix (1,2,7-Month) Group.|||Participants|||Count of Participants
2640330|NCT01755689|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response|"rSBA vaccine response for serogroups A, C, W-135 and Y was defined as:~For initially seronegative subjects (pre-vaccination titre below the cut-off of 1:8): number of subjects with rSBA antibody titres ≥ 1:32 one month after vaccination.~For initially seropositive subjects (pre-vaccination titre ≥ 1:8): number of subjects with rSBA antibody titres at least four times the pre-vaccination antibody titres, one month after vaccination."|At one month after Nimenrix vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Nimenrix.|||Participants|||Count of Participants
2640331|NCT01755689|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128|The number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:8 and ≥ 1:128 prior to and one month after vaccination with Nimenrix vaccine.|Prior to and one month after vaccination with Nimenrix (Months 0 and 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Nimenrix.|||Participants|||Count of Participants
2640332|NCT01755689|Primary|Anti-Pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations|The antibody concentrations were tabulated as GMCs and expressed as IU/mL. GMCs were only analyzed in subjects receiving Boostrix vaccination.|At one month after Boostrix vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.|||IU/mL||95% Confidence Interval|Geometric Mean
2640333|NCT01755689|Primary|Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Concentrations Equal to or Above (≥) 1.0 IU/mL|The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL). This analysis was only performed on the groups receiving Boostrix vaccine.|At one month after Boostrix vaccination (Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.|||Participants|||Count of Participants
2640334|NCT01755689|Primary|Anti-HPV-16 and Anti-HPV-18 Concentrations|The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL).|At one month after vaccination with Cervarix (Month 7)|The analysis was performed on the ATP cohort for immunogenicity after Cervarix vaccination, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination.|||EU/mL||95% Confidence Interval|Geometric Mean
2640335|NCT01755689|Primary|Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA)|The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers, tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement. This analysis was only performed on groups receiving Nimenrix vaccine.|At one month after vaccination with Nimenrix (Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Nimenrix.|||Titers||95% Confidence Interval|Geometric Mean
2640336|NCT01755637|Secondary|Cmax of Active Metabolite - Albendazole Sulphoxide|Cmax was depicted from plasma concentration of Albendazole.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Missing data was not imputed for evaluation.|||ng/mL||Standard Deviation|Mean
2640337|NCT01755637|Secondary|AUC (0-inf) of Active Metabolite - Albendazole Sulphoxide|AUC (0-inf) of Albendazole sulphoxide was evaluated using the trapezoid rule.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Participants were excluded where the baseline concentration was greater than 5% of Cmax.|||ng.hr/mL||Standard Deviation|Mean
2640338|NCT01755637|Secondary|AUC (0-t) of Active Metabolite - Albendazole Sulphoxide|AUC (0-t) of Albendazole i.e. Albendazole sulphoxide was evaluated using the trapezoid rule.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Participants were excluded where the baseline concentration was greater than 5% of Cmax.|||ng.hr/mL||Standard Deviation|Mean
2640340|NCT01755637|Primary|Maximum Observed Plasma Concentration [Cmaximum (Max)] of Albendazole|Cmax was depicted from plasma concentration of Albendazole.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Missing data was not imputed for evaluation.|||ng/mL||Standard Deviation|Mean
2640341|NCT01755637|Primary|AUC [0-infinity (Inf)] of Albendazole|AUC (0-inf) was evaluated using the trapezoid rule.|Blood samples were collected pre-dose at 0 hr and post dose at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Missing data was not imputed for evaluation.|||ng.hr/mL||Standard Deviation|Mean
2640342|NCT01755637|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)] of Albendazole.|AUC (0-t) was evaluated using the trapezoid rule.|Blood samples were collected pre-dose 0 hour (hr) and post dose 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 7, 9, 12, 16, 24 and 36 hr|The analysis was carried out per protocol population. Missing data was not imputed for evaluation.|||nanogram (ng).hr per milliliter (mL)||Standard Deviation|Mean
2640343|NCT01755598|Secondary|Number of Seropositive Subjects for M72 Antibodies Measured by ELISA in the Safety and Immune Sub-cohort|A seronegative subject was a subject whose antibody concentration was below 2.8 EU/mL, while a seropositive subject was a subject whose antibody concentration was greater than or equal to 2.8 EU/mL.|Prior to dose 1 (Day 0) and post-dose 2 (Day 60, Year 1, Year 2 and Year 3)|Analysis was performed on the “safety and immunogenicity” sub-cohort (i.e. about 150 subjects enrolled in each group and from 2 of the 3 countries [the third country study start was delayed as awaiting regulatory approval]) which included subjects with at least 1 cell-mediated immune result documented.|||Participants|||Count of Participants
2640344|NCT01755598|Secondary|M72-specific Antibody Concentrations as Measured by Enzyme Linked Immuno Sorbent Assay (ELISA) in the Safety and Immune Sub-cohort|Mycobacterium tuberculosis M72-specific antibody geometric mean concentrations (GMCs) with exact 95% Confidence Interval (CI) were measured by Enzyme Linked Immuno Sorbent Assay (ELISA) and expressed in ELISA unit per milliliter (EU/mL). The cut-off of the assay was 2.8 EU/mL. The Geometric Mean Concentration (GMC) calculations were performed by taking the anti-log of the mean of the log10 concentration transformations. For descriptive statistics purposes only, antibody concentrations below the cut-off value of the assay was given an arbitrary value of half the cut-off value for the purpose of GMC calculation.|Prior to dose 1 (Day 0) and post-dose 2 (Day 60, Year 1, Year 2 and Year 3)|Analysis was performed on the “safety and immunogenicity” sub-cohort (i.e. about 150 subjects enrolled in each group and from 2 of the 3 countries [the third country study start was delayed as awaiting regulatory approval]) which included subjects with at least 1 cell-mediated immune result documented.|||EU/mL||95% Confidence Interval|Geometric Mean
2640345|NCT01755598|Secondary|Desciptive Statistics of the Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers in the Safety and Immune Sub-cohort|The frequency of M72-specific CD8 + T-cells per million cells were identified after in vitro stimulation expressing any combination of immune markers ( Interleukin-2 (IL-2), cluster of differentiation 40-ligand (CD40-L), tumor necrosis factor alpha (TNF-) and interferon-gamma (IFN-) after background subtraction for each treatment group.|Prior to dose 1 (Day 0) and post-dose 2 (Day 60, Year 1, Year 2 and Year 3)|Analysis was performed on the “safety and immunogenicity” sub-cohort (i.e. about 150 subjects enrolled in each group and from 2 of the 3 countries [the third country study start was delayed as awaiting regulatory approval]) which included subjects with at least 1 immune result documented.|||T cells per million cells||Inter-Quartile Range|Median
2640346|NCT01755598|Secondary|Desciptive Statistics of the Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers in the Safety and Immune Sub-cohort|The frequency of M72-specific CD4 + T-cells per million cells were identified after in vitro stimulation expressing any combination of immune markers ( Interleukin-2 (IL-2), cluster of differentiation 40-ligand (CD40-L), tumor necrosis factor alpha (TNF-) and interferon-gamma (IFN-) after background subtraction for each treatment group.|Prior to dose 1 (Day 0) and post-dose 2 (Day 60, Year 1, Year 2 and Year 3)|Analysis was performed on the “safety and immunogenicity” sub-cohort (i.e. about 150 subjects enrolled in each group and from 2 of the 3 countries [the third country study start was delayed as awaiting regulatory approval]) which included subjects with at least 1 immune result documented.|||T cells per million cells||Inter-Quartile Range|Median
2640347|NCT01755598|Secondary|Number of Subjects With Grade Equal or Greater Than 2 of Severity for Haematological and Biochemichal Abnormal Laboratory Values in the Safety and Immune Sub-cohort|Abnormal laboratory values include haematological abnormalities (haemoglobin level, white blood cells and platelets) and biochemical abnormalities (alanine aminotransferase, aspartate aminotransferase and creatinine). Grading was defined based on the Food and Drug Administration [FDA], 2007. Guidance for Industry, Toxicity Grading Scale for Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Alanine Aminotransferase = ALA; Aspartate Aminotransferase = ASP; Creatinine = CREA; Hemoglobin (Change from baseline) = HEM (baseline); Hemoglobin (decrease) = HEM (decrease); Leukocytes (White Blood Cells) (Decrease) = WBC (decrease); Leukocytes (White Blood Cells) (Increase) = WBC (increase); Platelets = PLA; Total Bilirubin = BIL.|Days 0, 7, 30 and 37|Analysis was performed on the “safety and immunogenicity” sub-cohort (i.e. about 150 subjects enrolled in each group and from 2 of the 3 countries [the third country study start was delayed as awaiting regulatory approval]) which included subjects with at least 1 laboratory value documented.|||Participants|||Count of Participants
2640348|NCT01755598|Secondary|Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From Day 0 to 6 months post-dose 2 (i.e. at Month 7)|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one dose administered.|||Participants|||Count of Participants
2640371|NCT01755156|Secondary|Kaplan-Meier Estimate of Cumulative Incidence of Participants Requiring Glycemic Rescue Therapy by 104 Weeks (Phase A+B)|Participants who did not meet progressively stricter glycemic criteria in Phase A had rescue initiated with open-label glimepiride. If during Phase B participants on open-label glimepiride or blinded glimepiride/glimepiride matching placebo needed rescue after maximum up-titration, then insulin glargine was initiated and the dose of open-label glimepiride or blinded glimepiride/glimepiride-matching placebo was discontinued.|Up to 104 weeks|All participants randomized population.|||Percentage of participants||95% Confidence Interval|Number
2640349|NCT01755598|Secondary|Number of Subjects With Any Solicited General AEs in the Safety and Immune Sub-cohort|Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], respiratory symptoms (including cough, blood in sputum, purulent sputum, shortness of breath or difficulties breathing, chest wall pain) headache, malaise and myalgia. Any = occurrence of the symptom regardless of intensity grade and relation to vaccination.|During the 7-day follow-up period (i.e.: day of vaccination and 6 subsequent days) after each vaccine dose|Analysis was performed on the “safety and immunogenicity” sub-cohort (i.e. about 150 subjects enrolled in each group and from 2 of the 3 countries [the third country study start was delayed as awaiting regulatory approval]) which included subjects with at least 1 vaccination dose documented.|||Participants|||Count of Participants
2640350|NCT01755598|Secondary|Number of Subjects With Any Solicited Local AEs in the Safety and Immune Sub-cohort|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Any redness/swelling symptom was scored as injection site redness/swelling with a diameter equal or larger than (≥) 20 millimeters (mm).|During the 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each vaccine dose|Analysis was performed on the “safety and immunogenicity” sub-cohort (i.e. about 150 subjects enrolled in each group and from 2 of the 3 countries [the third country study start was delayed as awaiting regulatory approval]) which included subjects with at least 1 vaccination dose documented.|||Participants|||Count of Participants
2640351|NCT01755598|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 30-day follow-up period following vaccination, across doses (i.e. day of vaccination and 29 subsequent days after each vaccine dose)|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one dose administered.|||Participants|||Count of Participants
2640352|NCT01755598|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 up to Year 3 (during the entire study period)|Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one dose administered.|||Participants|||Count of Participants
2640353|NCT01755598|Secondary|Incidence Rates of Clinical TB Disease, Meeting the Case Definition 5|The incidence rate of Clinical TB disease (or 100 Person-years rate) was calculated as the number of subjects reporting at least one case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Case definition 5 = a subject for whom a clinician has diagnosed TB disease and has decided to treat the patient with TB treatment.|From Day 60 (i.e one month after Dose 2) up to Year 3: follow-up period for cases ends at the first occurrence of an event. For the non-cases: follow-up period ends at the date of the Month 36 visit or last contact date whichever comes first|Analysis was performed on the According-to-Protocol cohort for efficacy which included all subjects who received all vaccinations according to protocol procedures within specified intervals that contributed time at risk in the follow-up period starting one month post dose 2 (Day 60).|||cases per 100 person-years||90% Confidence Interval|Number
2640354|NCT01755598|Secondary|Incident Rates of Microbiological Pulmonary TB Disease, Meeting the Case Definition 4|The incidence rate of Microbiological pulmonary TB disease (or 100 Person-years rate) was calculated as the number of subjects reporting at least one case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Case definition 4 = a subject with clinical suspicion* of pulmonary TB disease, with Mtb complex identified from a sputum specimen, taken up to four weeks after initiation of TB treatment, by Xpert MTB/RIF and/or microbiological culture.*Clinical suspicion of pulmonary TB was defined as a subject presenting with one or more of the following symptoms: unexplained cough > 2 weeks, unexplained fever > 1 week, night sweats, unintentional weight loss, pleuritic chest pains, haemoptysis, fatigue or shortness of breath on exertion.|From Day 60 (i.e one month after Dose 2) up to Year 3: follow-up period for cases ends at the first occurrence of an event. For the non-cases: follow-up period ends at the date of the Month 36 visit or last contact date whichever comes first|Analysis was performed on the According-to-Protocol cohort for efficacy which included all subjects who received all vaccinations according to protocol procedures within specified intervals that contributed time at risk in the follow-up period starting one month post dose 2 (Day 60).|||cases per 100 person-years||90% Confidence Interval|Number
2640355|NCT01755598|Secondary|Incident Rates of Definite Pulmonary TB Disease, Not Associated With HIV-infection Meeting the Case Definition 3|The incidence rate of definite pulmonary TB disease (or 100 Person-years rate) was calculated as the number of subjects reporting at least one case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Case definition 3 = a subject with clinical suspicion* of pulmonary TB disease, with Mtb complex identified from a sputum specimen, taken up to four weeks after initiation of TB treatment, by Xpert MTB/RIF and/or microbiological culture and confirmed HIV-negative at the time of TB diagnosis.*Clinical suspicion of pulmonary TB was defined as a subject presenting with one or more of the following symptoms: unexplained cough > 2 weeks, unexplained fever > 1 week, night sweats, unintentional weight loss, pleuritic chest pains, haemoptysis, fatigue or shortness of breath on exertion.|From Day 60 (i.e one month after Dose 2) up to Year 3: follow-up period for cases ends at the first occurrence of an event. For the non-cases: follow-up period ends at the date of the Month 36 visit or last contact date whichever comes first|Analysis was performed on the According-to-Protocol cohort for efficacy which included all subjects who received all vaccinations according to protocol procedures within specified intervals that contributed time at risk in the follow-up period starting one month post dose 2 (Day 60).|||cases per 100 person-years||90% Confidence Interval|Number
2640372|NCT01755156|Secondary|Kaplan-Meier Estimate of Cumulative Incidence of Participants Requiring Glycemic Rescue Therapy by 24 Weeks (Phase A)|Participants who did not meet progressively stricter glycemic criteria in Phase A had rescue initiated with open-label glimepiride.|Up to 24 weeks|All participants randomized population.|||Percentage of participants||95% Confidence Interval|Number
2640356|NCT01755598|Secondary|Incident Rates of Definite Xpert MTB/Rif Positive Pulmonary TB Disease, Not Associated With HIV-infection, Meeting the Case Definition 2|The incidence rate of definite Xpert MTB/Rif positive pulmonary TB disease, expressed in terms of 100 Person-years rate, was calculated as the number of subjects reporting at least one case (n) in a group over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Case definition 2 = a subject with clinical suspicion* of pulmonary TB disease, with Mtb complex identified from a sputum specimen, taken before initiation of TB treatment, by Xpert MTB/RIF and confirmed HIV-negative at the time of TB diagnosis. *Clinical suspicion of pulmonary TB was defined as a subject presenting with one or more of the following symptoms: unexplained cough > 2 weeks, unexplained fever > 1 week, night sweats, unintentional weight loss, pleuritic chest pains, haemoptysis, fatigue or shortness of breath on exertion.|From Day 60 (i.e one month after Dose 2) up to Year 3: follow-up period for cases ends at the first occurrence of an event. For the non-cases: follow-up period ends at the date of the Month 36 visit or last contact date whichever comes first|Analysis was performed on the According-to-Protocol cohort for efficacy which included all subjects who received all vaccinations according to protocol procedures within specified intervals that contributed time at risk in the follow-up period starting one month post dose 2 (Day 60).|||cases per 100 person-years||90% Confidence Interval|Number
2640357|NCT01755598|Primary|Incident Rates of Definite Pulmonary Tuberculosis (TB) Disease, Not Associated With HIV-infection, Meeting the Case Definition 1|The incidence rate of definite pulmonary TB disease (or 100 Person-years rate) was calculated as the number of subjects reporting at least one case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 100. Case definition 1 = subject with clinical suspicion of pulmonary TB disease*, with Mycobacterium tuberculosis (Mtb) complex identified from sputum specimen, taken before initiation of TB treatment, by Xpert MTB/RIF (Nucleic Acid Amplification Test to detect Mtb complex and resistance to rifampicin in sputum samples) and/or microbiological culture and confirmed Human Immunodeficiency Virus (HIV)-negative at the time of TB diagnosis. *Clinical suspicion of pulmonary TB defined as subject presenting with 1 or more of the following symptoms: unexplained cough > 2 weeks, unexplained fever > 1 week, night sweats, unintentional weight loss, pleuritic chest pains, haemoptysis, fatigue or shortness of breath on exertion.|From Day 60 (i.e one month after Dose 2) up to Year 3: follow-up period for cases ends at the first occurrence of an event. For the non-cases: follow-up period ends at the date of the Month 36 visit or last contact date whichever comes first|Analysis was performed on the According-to-Protocol cohort for efficacy which included all subjects who received all vaccinations according to protocol procedures within specified intervals that contributed time at risk in the follow-up period starting one month post dose 2 (Day 60).|||cases per 100 person-years||90% Confidence Interval|Number
2640358|NCT01755546|Primary|Change From Baseline to Week 48 in Daily Average NRS Pain Intensity Score|The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and the change from baseline at week 48 is presented.|48 weeks|Efficacy Population|||units on a scale||Standard Deviation|Mean
2640359|NCT01755455|Secondary|Change From Baseline in Sputum Iron (ng/mg)||Baseline and 6 weeks||||ng/mg||Standard Error|Mean
2640360|NCT01755455|Secondary|Change From Baseline in Transferrin Saturation (%)||Baseline and 6 weeks||||% saturation||Standard Error|Mean
2640361|NCT01755455|Secondary|Change From Baseline in Serum Iron (mcg/dl)||Baseline and 6 weeks||||mcg/dl||Standard Error|Mean
2640362|NCT01755455|Primary|Change From Baseline in Hemoglobin Concentration (gm/dl)||Baseline and 6 weeks||||gm/dl||Standard Error|Mean
2640363|NCT01755416|Primary|Blood Glucose Measures in Subjects on Closed Loop With Insulin and Liraglutide, Compared to the Closed Loop With Insulin Alone|Measure of targeted blood glucose levels in the Closed Loop setting in the treatment arm, with the addition of Liraglutide compared to insulin monotherapy (continuous subcutaneous insulin infusion)|0-1500 min||||mg/dl||Standard Deviation|Mean
2640364|NCT01755234|Secondary|Opioid Use Discharge From Post Anesthesia Care Unit to 24 Hours After PACU Discharge.|Opioid use in mg of morphine equivalents from discharge from the post anesthesia care unit to 24 hours after PACU discharge.|Discharge from PACU to 24 hours post operative after PACU discharge.||||mg morphine equivalents||Inter-Quartile Range|Median
2640365|NCT01755234|Secondary|Pain in Post Anesthesia Care Unit|"Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve in the post anesthesia care unit ( score * min). A higher value indicates more pain and time in the Post Anesthesia Care Unit.~The range is 0 pain to x time in minutes x 1 hour to 5 hour ( 60-300 minutes) . The pain scores were collected at 15 minute intervals from the time of admission to the PACU. The area under the NRS pain scale versus time curve was calculated using the trapezoidal method as an indicator of pain burden during early recovery (Graph Pad Prism ver 5.03, Graph Pad Software INC."|Time in the post anesthesia care unit||||Pain Score * minutes in PACU||Inter-Quartile Range|Median
2640366|NCT01755234|Secondary|Mg of Morphine Equivalents (IV)|Total opioid use in the post operative care unit (Mg of morphine equivalents)|PACU admission to discharge||||miligrams of morphine equivalents||Inter-Quartile Range|Median
2640367|NCT01755234|Primary|Quality of Recovery Score 24 Hours Post Operative|Quality of recovery score 24 hours after the surgical procedure.Score of 40 is poor recovery and a score of 200 is good recovery.|24 hours after the surgical procedure||||units on a scale||Inter-Quartile Range|Median
2640368|NCT01755169|Primary|Number of Participants With Dose Limiting Toxicity|A total of 7 patients enrolled on the trial. However, 2 participants withdrew from the trial before they were randomized and 1 participant withdrew from the trial before being treated. Hence, the total number of patients for assessment is 4.|2 weeks||||Participants|||Count of Participants
2640369|NCT01755156|Secondary|Percentage of Participants Requiring Glycemic Rescue Therapy at or Before Week 104 (Phase A+B)|Data presented are a cumulative incidence of participants with glycemic rescue by Week 104.|Up to 104 weeks|All participants randomized population.|||Percentage of participants|||Number
2640370|NCT01755156|Secondary|Percentage of Participants Requiring Glycemic Rescue Therapy at or Before Week 24 (Phase A)|Data presented are a cumulative incidence of participants with glycemic rescue by Week 24.|Up to 24 weeks|All participants randomized population.|||Percentage of participants|||Number
2640373|NCT01755156|Secondary|Change From Baseline in Fasting Insulin at Week 104 (Phase A+B)|Change from baseline in fasting insulin at Week 104 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 104|Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.|||μIU/mL||95% Confidence Interval|Least Squares Mean
2640374|NCT01755156|Secondary|Change From Baseline in Fasting Insulin at Week 24 (Phase A)|Change from baseline in fasting insulin at Week 24 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 24|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.|||micro International Unit (μIU)/mL||95% Confidence Interval|Least Squares Mean
2640375|NCT01755156|Secondary|Change From Baseline in PMG Total Area Under the Plasma Concentration Time Curve (AUC) at Week 24 (Phase A)|Change from baseline in PMG total AUC at Week 24 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment. Plasma glucose levels were measured before the meal (0 minutes), and at 60 and 120 minutes after the meal.|Baseline and Week 24|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.|||mg*h/dL||95% Confidence Interval|Least Squares Mean
2640376|NCT01755156|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <6.5% After 104 Weeks of Treatment (Phase A+B)|Percentage of participants attaining A1C glycemic goals of <6.5% (48 mmol/mol) after 104 weeks of treatment estimated using standard multiple imputation techniques.|104 weeks|Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.|||Percentage of participants||95% Confidence Interval|Least Squares Mean
2640377|NCT01755156|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7% After 104 Weeks of Treatment (Phase A+B)|Percentage of participants attaining A1C glycemic goals of <7.0% (53 mmol/mol) after 104 weeks of treatment estimated using standard multiple imputation techniques.|104 weeks|Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.|||Percentage of participants||95% Confidence Interval|Least Squares Mean
2640378|NCT01755156|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <6.5% After 24 Weeks of Treatment (Phase A)|Percentage of participants attaining A1C glycemic goals of <6.5% (48 mmol/mol) after 24 weeks of treatment estimated using standard multiple imputation techniques.|24 weeks|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.|||Percentage of participants||95% Confidence Interval|Number
2640379|NCT01755156|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7.0% After 24 Weeks of Treatment (Phase A)|Percentage of participants attaining A1C glycemic goals of <7.0% (53 mmol/mol) after 24 weeks of treatment estimated using standard multiple imputation techniques.|24 weeks|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.|||Percentage of participants||95% Confidence Interval|Number
2640380|NCT01755156|Secondary|Change From Baseline in FPG at Week 104 (Phase A+B)|Change from baseline in FPG at Week 104 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 104|Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2640381|NCT01755156|Secondary|Change From Baseline in A1C at Week 104 (Phase A+B)|A1C is measured as a percent. Change from baseline in A1C at Week 104 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 104|Full analysis set population included all randomized participants who received at least one dose of study medication and had a baseline measurement or a post-randomization measurement.|||Percent||95% Confidence Interval|Least Squares Mean
2640382|NCT01755156|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Phase A)|Change from baseline in FPG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 24|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2640383|NCT01755156|Secondary|Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 (Phase A)|Change from baseline in 2-hour PMG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 24|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2640384|NCT01755156|Primary|Percentage of Participants Who Experienced an Adverse Event Which Were Included Under the System Order Class of Investigations (Phase A+B)|The following laboratory parameters were included: blood chemistry, hematology, electrocardiograms, lipids, body weight, and vital signs.|Up to 104 weeks|All participants as treated population included all participants who received at least one dose of study medication.|||Percentage of participants|||Number
2640385|NCT01755156|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A+B)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.|Up to 104 weeks|All participants as treated population included all participants who received at least one dose of study medication.|||Percentage of participants|||Number
2656167|NCT01618942|Primary|Pressure Pain Threshold (PPT)With 1 cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure||||kg/cm2||Standard Deviation|Mean
2640386|NCT01755156|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (Phase A+B)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.|Up to 107 weeks|All participants as treated population included all participants who received at least one dose of study medication.|||Percentage of participants|||Number
2640387|NCT01755156|Primary|Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24 (Phase A)|A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment.|Baseline and Week 24|Full analysis set population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement.|||Percent||95% Confidence Interval|Least Squares Mean
2640388|NCT01755143|Secondary|Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Ventricular Sensing Amplitude|Subjects' ventricular sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in ventricular sensed amplitude between the two visits.|Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period||||participants|||Number
2640389|NCT01755143|Secondary|Occurrence of Sustained Ventricular Arrhythmias and Asystole During MRI Scans.|The endpoint was the occurrence of sustained ventricular arrhythmias and asystole during MRI scans and attributable to the MR scan. Sustained ventricular arrhythmias or asystole episodes that occurred during the MRI scan was considered attributable to the MR scan if so adjudicated by the Adverse Events Adjudication Committee|During MRI scans (9-12 weeks post-implant)||||participants|||Number
2640390|NCT01755143|Secondary|Proportion of Subjects Who Experience a Decrease Less Than or Equal to 50% in Atrial Sensing Amplitude|Subjects' atrial sensed amplitude was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was defined as a 50% or less decrease in atrial sensed amplitude between the two visits.|Pre-MRI /waiting period (9-12 weeks post-implant) to 1-month post-MRI/waiting period|Only subjects with measured sensed amplitude values at both pre-MRI/waiting period and the 4-month visit were used in the analysis.|||participants|||Number
2640391|NCT01755143|Primary|Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Ventricular Voltage Thresholds|Subjects' ventricular pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.|Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period||||participants|||Number
2640392|NCT01755143|Primary|Proportion of Subjects Who Experience an Increase Less Than or Equal to 0.5V in Atrial Voltage Thresholds|Subjects' atrial pacing capture threshold was measured at the 9-12 week visit (pre-MRI/waiting period) and the 4-month visit (i.e. one month post-MRI/waiting period). A success was when a subject experienced an increase less than or equal to 0.5V (volts) between the two visits.|Pre-MRI/waiting period (9-12 weeks post implant) to one month post-MRI/waiting period|To be included in the analysis, subjects in the MRI group must undergo an MRI scan and those in the Control group must complete the 9-12 week visit, and all the subjects must have valid pacing capture threshold measurements at pre-MRI/waiting period and the 4-month visit.|||participants|||Number
2640393|NCT01755143|Primary|MRI-related Complication Free Rate|Number of patients free of MRI-related complications|MRI scan to one month later|Patients who underwent an MRI|||participants|||Number
2640394|NCT01755091|Secondary|Change in Desaturation Time (DT)|Change in DT (total minutes with arterial oxygen saturation below 85% during 8-hour polysomnography) derived as: DT (end of treatment) minus DT (pre-treatment)|6 weeks||||minutes||Standard Deviation|Mean
2640395|NCT01755091|Secondary|Adverse Events (AEs)|AEs will be evaluated and tracked throughout subject participation (up to 8 weeks)|Up to 8 weeks||||Number of adverse events per participant||Standard Deviation|Mean
2640396|NCT01755091|Secondary|Tolerability by Treatment Satisfaction Questionnaire for Medications (TSQM) Overall Score.|"The TSQM measures a person's satisfaction with treatment based on a 7-point scale ranging from Extremely Dissatisfied to Extremely Satisfied in response to the question, Taking all things into account, how satisfied or dissatisfied are you with this medication?."|Week 6|Data are missing for one participant randomized to receive Placebo treatment due to technical error in not collecting the instrument.|||Participants|||Count of Participants
2640397|NCT01755091|Primary|Change in Sleep Latency: Maintenance of Wakefulness Test (MWT)|Change in MWT derived as: MWT (end of treatment) minus MWT (pre-treatment). The Maintenance of Wakefulness Test measures a person's ability to stay awake in a quiet, dark and nonstimulating room for a period of time.|Baseline and Week 6||||minutes||Standard Deviation|Mean
2640398|NCT01755091|Primary|Change in Epworth Sleepiness Scale (ESS)|Change in ESS derived as: ESS (end of treatment) minus ESS (pre-treatment). The ESS scale has a range of 0 to 24, with 0 representing the least degree of sleepiness and 24 the greatest degree of sleepiness. There are no subscales.|Baseline and Week 6|Data are missing for 2 participants randomized to receive Placebo treatment; due to technical error in not completing this instrument.|||units on a scale||Standard Deviation|Mean
2640399|NCT01755091|Primary|Change in Apnea/Hypopnea Index (AHI)|Change in AHI derived as: AHI (end of treatment) minus AHI (pre-treatment)|Baseline and Week 6|Analysis performed including all participants who completed the full 6-weeks of treatment.|||events/hour||Standard Deviation|Mean
2640400|NCT01755026|Primary|Cefazolin Levels|Cefazolin levels|2 hours||||mcg/mL||Standard Error|Mean
2640401|NCT01754987|Secondary|Number of Participants That Are Alive After 15 Weeks of Treatment.|To evaluate duration of tumor response and progression-free survival|15 weeks+|The trial was closed early due to lack of accrual. The data were not collected or analyzed.||||||
2640437|NCT01754714|Secondary|Methionine Volume of Distribution at Week 7 (L)|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*||||L||Standard Deviation|Mean
2676189|NCT01440569|Secondary|Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24 (Snapshot Analysis)||Week 24|Full Analysis Set|||percentage of participants|||Number
2640402|NCT01754987|Secondary|Mean Value Collected Using the Functional Assessment of Cancer Therapy-General (FACT-G) Quality Assessment Instrument|To evaluate quality of life using Functional Assessment of Cancer Therapy-General (FACT-G) quality assessment instrument. The FACT-G questionnaire will be used to assess quality-of-life longitudinally. Quality-of-life scores obtained from the FACT-G will be summarized at multiple time points. Five-point scale from 0 (not at all) to 4 (very much)|16 weeks +/- 2 weeks|The trial was closed early due to lack of accrual. The data were not collected or analyzed.||||||
2640403|NCT01754987|Secondary|Overall Tumor Response Rate|To utilize CT or PET/CT scans to assess overall tumor response rate (complete) in subjects with advanced metastatic hepatocellular cancer treated with the combination of ascorbic acid and sorafenib versus sorafenib alone.|16 weeks +/- 2 weeks|The trial was closed early due to lack of accrual. The data were not collected or analyzed.||||||
2640404|NCT01754987|Primary|Number of Participants That Experience Serious Adverse Events.|The primary aim is to assess whether or not (IV) Ascorbic Acid (AA) with sorafenib therapy is relatively safe and well-tolerated according to Common Terminology Criteria for Adverse Events (CTCAE)v4.0|16 weeks +/- 2 weeks|The trial was closed early due to lack of accrual. The data were not collected or analyzed.||||||
2640405|NCT01754922|Primary|Heart Rate Variability|Ratio of low-frequency to high-frequency power for heart rate variability|Resting baseline; cross-sectional|Signal quality of the the electrocardiogram was poor for 3 individuals; therefore, their data were removed from final analysis.|||Ratio||Standard Deviation|Mean
2640406|NCT01754922|Primary|VO2 Peak|Maximal oxygen consumption measured during exercise|At peak exercise; cross-sectional|4 participants were excluded due to failure to meet maximal exercise criteria (3 from exposed, 1 from control). Therefore, we removed these individuals from the final analysis.|||ml/min/kg||Standard Deviation|Mean
2640407|NCT01754922|Primary|FEV1|Forced expiratory volume in 1 second (FEV1) measured before and after an exercise challenge|Pre/post exercise; cross-sectional||||percentage of predicted normal values||Standard Deviation|Mean
2640408|NCT01754909|Secondary|Number of Participants With Radiation Fibrosis|The occurrence and grade of radiation fibrosis by radiographic criteria, using CT scanning|one year||||participants|||Number
2640409|NCT01754909|Secondary|Number of Participants With Radiation Pneumonitis by CT Scan|The occurrence and grade of radiation pneumonitis by radiographic criteria, using CT scanning|six months|analyzed by CT scan readings done in a masked fashion|||Participants|||Count of Participants
2640410|NCT01754909|Primary|Number of Participants With Radiation Pneumonitis|The clinical occurrence and grade of radiation pneumonitis, by National Cancer Institute Common Terminology Criteria Adverse Event grading ( NCI CTCAE)|two years||||participants|||Number
2640411|NCT01754766|Secondary|Conjunctival Hyperemia Score|Conjunctival hyperemia is the engorgement of the blood vessels (redness) of the clear membrane covering the white surface of the eye. Conjunctival hyperemia was evaluated 15 minutes post conjunctival allergen challenge (CAC) (8 hours post dose) on Day 1 for both eyes using a 9-point scale in half-unit increments where: 0=none to 4=Extremely severe. The score for each participant was the average of the score of both eyes.|Day 1|Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point|||Score on a scale||Standard Deviation|Mean
2640412|NCT01754766|Secondary|Ocular Itching Score at Day 15|The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (16 hours post-dose) at Day 15 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.|Day 15|Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point|||Score on a scale||Standard Deviation|Mean
2640413|NCT01754766|Primary|Ocular Itching Score at Day 1|The participant evaluated ocular itching in both eyes 5 minutes post conjunctival allergen challenge (CAC) (8 hours post-dose) at Day 1 using a 9-point scale in half-unit increments where: 0=none to 4=incapacitating itch with an irresistible urge to rub. The score for each participant was the average of the score of both eyes.|Day 1|Modified Intent-to-treat (MITT) population included all randomized participants with ocular itching score data available for this time point|||Score on a scale||Standard Deviation|Mean
2640414|NCT01754727|Secondary|Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score|The BASFI is a numeric rating scale that uses self-reported patient evaluations to measure physical function impairment caused by AS. It is a ten questions, each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment). The mean of the ten questions was the total BASFI score. A higher score indicates more severe impairment of functioning.|Month 3, Month 6, Month 9 and Month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
2640415|NCT01754727|Secondary|Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score|The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Higher scores indicate higher disease activity. Remission is defined as ASDAS score <1.3. Clinically important improvement is defined as a change >= 1.1 units, and major improvement is defined as a change >= 2.0 units.|Month 3, Month 6, Month 9 and Month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
2640416|NCT01754727|Secondary|Mean Change From Baseline in BASDAI Score|The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms).|Month 3, Month 6, Month 9, Month 12 and Month 12 Last Observation Carried Forward (LOCF)|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||units on a scale||Standard Deviation|Mean
2640417|NCT01754727|Secondary|Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider|Difference in the number of outpatient visits to each kind of health care provider which includes general practitioner, rheumatologist, other specialists (ophthalmologist, gastroenterologist, dermatologist, physiatrist), physiotherapist and rheumatology nurse, during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.|12 months prior to month 0 (baseline) and 12 months prior to month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||Number of visits||Standard Deviation|Mean
2640418|NCT01754727|Secondary|Mean Change in the Number of Sick Leaves|Difference in the number of sick leaves during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only).|12 months prior to month 0 (baseline) and 12 months prior to month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||Number of sick leaves||Standard Deviation|Mean
2640419|NCT01754727|Secondary|Mean Change in the Number of Sick Leave Days|Difference in the number of sick leave days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only)|12 months prior to month 0 (baseline) and 12 months prior to month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||Days||Standard Deviation|Mean
2640420|NCT01754727|Secondary|Mean Change in the Number of Hospitalizations|Difference in the number of hospitalizations during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.|12 months prior to month 0 (baseline) and 12 months prior to month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||Number of admissions to hospital||Standard Deviation|Mean
2640421|NCT01754727|Secondary|Mean Change in the Number of Hospital Inpatient Days|Difference in the number of hospital inpatient days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.|12 months prior to month 0 (baseline) and 12 months prior to month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||Days||Standard Deviation|Mean
2640422|NCT01754727|Secondary|Percentage of Participants Achieving At Least 2.0 Score Decrease in Ankylosing Spondylitis Disease Activity (ASDAS) Score From Baseline|The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Higher scores indicate higher disease activity. Clinically important improvement is defined as a change >= 1.1 units, and major improvement is defined as a change >= 2.0 units.|Month 3, Month 6, Month 9 and Month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||percentage of participants|||Number
2640423|NCT01754727|Secondary|Percentage of Participants Achieving BASDAI 50|The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline.|Month 3, Month 6 and Month 9|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||percentage of participants|||Number
2640424|NCT01754727|Primary|Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12|The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline as observed.|Month 0 (baseline) and Month 12|Analysis included all participants who received at least one dose of adalimumab with evaluable data.|||percentage of participants|||Number
2640425|NCT01754714|Secondary|Hepatic Panel (Liver Laboratory Parameters)|ALT/AST ratio|change from baseline at 6 weeks||||Ratio||Standard Deviation|Mean
2640426|NCT01754714|Secondary|Area Under Curve (AUC) of Average Methionine Concentration Versus Time Curve|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours *at Week 7*||||mcg/mL||Standard Deviation|Mean
2640427|NCT01754714|Secondary|Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)|Hyaluronic acid|change from baseline at 6 weeks||||ng/mL||Standard Deviation|Mean
2640428|NCT01754714|Secondary|Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)|Caspase-cleaved cytokeratin (CK 18)|change from baseline at 6 weeks||||U/L||Standard Deviation|Mean
2640429|NCT01754714|Secondary|Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)|oxidative stress marker (isoprostane level)|change from baseline at 6 weeks||||ng/mg Crea||Standard Deviation|Mean
2640430|NCT01754714|Secondary|Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)|glutathione in erythrocytes|change from baseline at 6 weeks||||mcmol/g||Standard Deviation|Mean
2640431|NCT01754714|Secondary|Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)|C-reactive Protein (CRP)|change from baseline at 6 weeks||||nmol/L||Standard Deviation|Mean
2640432|NCT01754714|Secondary|Metabolic Panel (Metabolic Laboratory Parameters)|Adiponectin|change from baseline at 6 weeks||||mcg/mL||Standard Deviation|Mean
2640433|NCT01754714|Secondary|Metabolic Panel (Metabolic Laboratory Parameters)|glycosylated hemoglobin (HbA1c)|change from baseline at 6 weeks||||Percentage||Standard Deviation|Mean
2640434|NCT01754714|Secondary|Metabolic Panel (Metabolic Laboratory Parameters)|Fasting plasma insulin|Change from baseline at 6 weeks||||pmol/L||Standard Deviation|Mean
2640435|NCT01754714|Secondary|13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test|Time to peak|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*||||minutes||Inter-Quartile Range|Median
2640436|NCT01754714|Secondary|13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test|Peak|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*||||Atom %C13||Standard Deviation|Mean
2640438|NCT01754714|Secondary|The Metabolic Clearance Rate Measured in the Blood.|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*||||L/h||Standard Deviation|Mean
2640439|NCT01754714|Other Pre-specified|Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)|"Non-invasive test for liver disease (ActiTest)/Fibrotest~FibroTest® : diagnoses hepatic fibrosis ActiTest® : assesses viral necro-inflammatory activity Scores between 0 and 1, the higher the score the worse~The FibroTest score is calculated from the results of a six-parameter blood test, combining six serum markers with the age and gender of the patient:Alpha-2-macroglobulin, Haptoglobin, Apolipoprotein A1, Gamma-glutamyl transpeptidase (GGT), Total bilirubin, and Alanine transaminase (ALT). ALT is used in a second assessment called ActiTest that is part of FibroTest."|change from baseline at 6 weeks||||scores on a scale||Standard Deviation|Mean
2640440|NCT01754714|Other Pre-specified|Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)|Cytokine profile ( Interleukin-6, IL-8, IL-10 (IL), Tumor Necrosis Factor (TNF -α), monocyte chemoattractant protein (MCP-1), and Granulocyte-colony stimulating factor (G-CSF ).|change from baseline at 6 weeks||||pg/mL||Standard Deviation|Mean
2640441|NCT01754714|Secondary|Metabolic Panel (Metabolic Laboratory Parameters)|Fasting lipid profile (cholesterol, HDL (High Density Lipoprotein), LDL (Low Density Lipoprotein)), amino acid profile, homeostasis model assessment (HOMA-R) and fasting glucose.|change from baseline at 6 weeks||||mmol/L||Standard Deviation|Mean
2640442|NCT01754714|Secondary|Hepatic Panel (Liver Laboratory Parameters)|Serum Total Bilirubin (STB), Serum Conjugated Bilirubin (SCB), liver-alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), Gamma Glutamyl Transpeptidase (GGT)|change from baseline at 6 weeks||||U/L||Standard Deviation|Mean
2640443|NCT01754714|Secondary|13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test|parameters cumulative percentage dose of 13 carbon recovered after 30, 60, 90 minutes (cPDR30, cPDR60, cPDR 90) will be evaluated|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*||||percentage of recovery||Standard Deviation|Mean
2640444|NCT01754714|Secondary|Fasting Methionine Concentration of Average Methionine Concentration Versus Time Curve.|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*||||mcg/mL||Standard Deviation|Mean
2640445|NCT01754714|Primary|Methionine Elimination Half-life Measured in Blood.|After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.|0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*||||hour||Standard Deviation|Mean
2640446|NCT01754688|Secondary|Community Bilirubin Induced Neurologic Dysfunction Score (C-BIND)|"We will translate the BIND II into lay language and have community workers administer it using pictures and/or short videos along with simple questions to the same infants that the doctors performed the BIND II, and compare the score of the community workers with those of the physicians to validate this score. The community workers will not examine the infants. They will do everything through questions and pictures and/or videos.~The bilirubin-induced neurologic dysfunction (BIND) scoring algorithm was developed, assigning 0, 1, 2 or 3 points to each of the four sections to indicate none, mild, moderate, or severe abnormalities in an infant's mental status, muscle tone, cry, and eye/facial findings. Each of the four sections has a maximum score of 3, giving a total BIND score range of 0 to 12. Higher scores indicate worsening signs of acute neurotoxicity associated with excessive hyperbilirubinemia."|Birth to 14 days||||units on a scale||Inter-Quartile Range|Median
2640447|NCT01754688|Primary|Bilirubin Induced Neurologic Dysfunction II Score (BIND II)|"The original BIND was developed in the USA to score infants with Acute Bilirubin Encephalopathy using a focused physical exam (primarily neurologic) and history to determine the degree of encephalopathy a infant with jaundice displayed. The BIND has been adapted for Low-Middle-Income Countries.~The bilirubin-induced neurologic dysfunction (BIND) scoring algorithm was developed, assigning 0, 1, 2 or 3 points to each of the four sections to indicate none, mild, moderate, or severe abnormalities in an infant's mental status, muscle tone, cry, and eye/facial findings. Each of the four sections has a maximum score of 3, giving a total BIND score range of 0 to 12. Higher scores indicate worsening signs of acute neurotoxicity associated with excessive hyperbilirubinemia."|Birth to 14 days|observational cross sectional study to validate a scoring tool, the BIND II, to diagnose ABE|||units on a scale||Inter-Quartile Range|Median
2640448|NCT01754623|Secondary|Overall Survival (OS) Rate|OS at time of analysis, calculated from date of enrollment to date of death from any cause.|12 months|All participants per group|||percentage of participants|||Number
2640449|NCT01754623|Secondary|Progression-Free Survival (PFS) at Three Years|PFS is defined as the duration of time from enrollment to time of death or progression of disease, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the longest diameter (LD) of the target lesion or appearance of new lesions at metastatic sites.|3 years|Evaluable participants at 3 years.||||||
2640450|NCT01754623|Primary|Margin-negative (R0) Resection Rate|R0 rate for all participants with resection. Margin negative surgery (R0 resection) is an absolute part of the curative treatment of pancreatic cancer.The primary endpoint is correlation of a radio sensitivity index score derived from the microarray analysis and pathologic response on surgical specimens. Tumor regression Rating: R0 (Complete Response). R0 resections are scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin are negative for tumor involvement.|Up to 3 years|All participants with resection|||percentage of participants|||Number
2640451|NCT01754519|Secondary|Disease Specific Survival|The disease specific survival will be analyzed using Kaplan-Meier method.|Up to 5 years|The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.||||||
2640452|NCT01754519|Secondary|Overall Survival|The overall survival will be analyzed using Kaplan-Meier method.|Up to 5 years|The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.||||||
2640453|NCT01754519|Secondary|Locoregional Control Rate|Locoregional control will be calculated with confidence interval estimates and will be compared to historical control rates.|At 5 years|The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.||||||
2640454|NCT01754519|Primary|Cosmetic Differences in the Treated Breast|Will measure differences in the cosmetic size, shape, or texture of the breast. Cosmesis will be graded according to the Baker Scale. Patient reported cosmesis will also be evaluated using the Ontario Clinical Oncology Breast Cancer Questionnaire.|Up to 2 years|The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.||||||
2640455|NCT01754519|Primary|Quality-of-life Assessments|Will be rated by patients using the POST-B, the Functional Assessment of Chronic Illness Therapy (FACIT), and the Skindex-16.|Up to 2 years|The study was terminated early by the IRB due to the fact that an IDE (Investigational Device Exemption) was never submitted. No outcome measure data was collected.||||||
2640456|NCT01754519|Primary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0.|Up to 2 years|All treated and eligible patients|||Participants|||Count of Participants
2640457|NCT01754493|Secondary|Somatization Module of the Patient's Health Questionnaire (PHQ-15)|Self-report 15-item scale measuring somatization symptoms (range 0-30); higher score indicates greater severity of somatization symptoms.|Measured at weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.|||units on a scale||Standard Deviation|Mean
2640458|NCT01754493|Secondary|Visual Analogue Scales (VAS)|Five self-report 11-point Likert scales measuring pain severity in the following domains (one item each): overall pain, pain interfering with daily activities, headaches, back pain, and shoulder pain. Range is 0-10; higher scores indicate higher pain severity.|Measured at weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.|||units on a scale||Standard Deviation|Mean
2640459|NCT01754493|Secondary|Clinician-Rated Global Impression Scales (CGI)|Two clinician-administered scales measuring level of change in (1) depressive symptoms and (2) IBS symptoms, assessed separately. Range is 1-7, ranging from very much improved (1) to very much worsened (7).|Measured at weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.|||units on a scale||Standard Deviation|Mean
2640460|NCT01754493|Primary|Gastrointestinal Symptoms Rating Scale (GSRS)|Clinician-administered 15-item scale measuring IBS symptoms (range 15-105); higher score indicates greater IBS severity.|Weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.|||units on a scale||Standard Deviation|Mean
2640461|NCT01754493|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|Clinician-administered 10-item scale measuring depressive symptoms (range 0-60); higher scores indicate greater severity of major depression.|Weeks 0, 8, 12|Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.|||units on a scale||Standard Deviation|Mean
2640462|NCT01754480|Secondary|Prevalence of Treatment Failures|Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments (with exception of reversal of heparin) or maneuvers at the target bleeding site after the start of treatment.|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study|||percent of subjects|||Number
2640463|NCT01754480|Secondary|Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points|"Cumulative proportion of subjects having achieved hemostasis by each of the following time points:~At 2 minutes following start of study treatment~At 5 minutes following start of study treatment~At 7 minutes following start of study treatment~At 10 minutes following start of study treatment"|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study|||Percent of subjects achieving hemostasis|||Number
2640464|NCT01754480|Secondary|Time to Hemostasis|Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start.|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study|||minutes||95% Confidence Interval|Median
2640465|NCT01754480|Secondary|Proportion of Subjects Achieving Hemostasis by Three Minutes After Treatment Start|Subjects achieving hemostasis at the target bleeding site by 3 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.|From start of treatment until 3 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study|||Percent of subjects achieving hemostasis|||Number
2640466|NCT01754480|Primary|Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start|Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.|From start of treatment until 4 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study|||Percent of subjects achieving hemostasis|||Number
2640467|NCT01754467|Secondary|Changes in Total Sedentary Time|Changes in total sedentary behavior will be assessed via accelerometry between baseline and 1 month|Baseline and 1 month|One individual outlier showed opposite changes as compared with the other participants and was 2.1 standard deviations above the mean for change in percent of day spent in sedentary behavior; thus this individual was excluded from this analysis.|||percentage of day spent sedentary||Standard Deviation|Mean
2640468|NCT01754467|Secondary|Breaks in Sedentary Behavior|Changes in the number of breaks in sedentary behavior will be assessed via accelerometry between baseline and 1 month|Baseline and 1 month||||breaks/day||Standard Deviation|Mean
2640469|NCT01754467|Secondary|Adherence to NEAT!|NEAT usage (days/month)|1 Month||||days||Standard Deviation|Mean
2640470|NCT01754467|Primary|Acceptability of NEAT!|How many participants would continue to use or use NEAT! in the future|1 month||||Participants|||Count of Participants
2640474|NCT01754402|Secondary|Overall Response Rate|"The number of patients achieving stable disease (SD), partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR)~sCR = CR as defined in Primary Outcome measure 2 plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence~VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or > 90% reduction in serum M-protein plus urine M-protein level < 100 mg/24 h~SD = Not meeting criteria for CR, VGPR, PR, or progressive disease"|up to 2 years|||||||
2640475|NCT01754402|Primary|Initial Response Rate|"The number of patients achieving a complete response (CR) or partial response (PR). Response is defined by the International Myeloma Working Group as:~CR- Negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and < 5% plasma cells in bone marrow~PR- > 50% reduction of serum M-protein and urine M-protein by >90% or to < 200 mg/24 h In addition, if present at baseline, a > 50% reduction in the size of soft tissue plasmacytomas is also required~VGPR - Serum and urine M-protein detectable by immunofixation but n"|2 cycles (approximately 2 months)|The overall number of participants analyzed reflects those who received at least 2 cycles of treatment. These participants were assessed for response at that time. The data reported indicates how many patients out of each cohort experienced at least a partial response or complete response.|||Participants|||Count of Participants
2640476|NCT01754402|Primary|Maximum Tolerated Dose of Pomalidomide and Bendamustine|"In the phase I dose escalation portion, patients will be sequentially enrolled in 4 cohorts at dose levels in a standard 3+3 design until the maximum tolerated dose (MTD) is reached.~Cohort 1 (bendamustine 120mg/m2 + pomalidomide 3mg); Cohort 2 (bendamustine 120mg/m2 + pomalidomide 4mg); Cohort 3 (bendamustine 150mg/m2 + pomalidomide 4mg); Cohort 4 (bendamustine 180mg/m2 + pomalidomide 4mg)~If dose limiting toxicity (DLT) is observed in 2 or more of the six patients at the same dosing level while DLT is observed in only 1 or none of the 6 patients at the dosing level immediately below it, then the lower dosing level will be defined as the maximum tolerated dose (MTD)."|2 cycles (approximately 2 months)|All patients enrolled in cohort 1 and 2 evaluable for DLT. Cohorts 3 and 4 were not evaluated due to both patients in Cohort 2 experiencing DLT.|||milligrams|||Number
2640477|NCT01754389|Secondary|Percentage of Participants With Chronic Graft Versus Host Disease|Rates of chronic GVHD 1 year after stem cell infusion|1 year||||Percentage of participants|||Number
2640478|NCT01754389|Secondary|Percentage of Participants With Progression-free and Overall Survival|Progression-free and overall survival 1 year post stem cell infusion|1 year||||Percentage of participants|||Number
2640479|NCT01754389|Secondary|Percentage of Participants With Relapse|Relapse relapse-cum-immunosuppression-free survival at 1 year after stem cell infusion|1 year||||Percentage of participants||95% Confidence Interval|Number
2640480|NCT01754389|Secondary|Percentage of Participants With Non-relapse Mortality|Non-relapse mortality by 1 year after stem cell infusion.|1 year||||Percentage of participants||95% Confidence Interval|Number
2640481|NCT01754389|Primary|Percentage of Participants With Incidence of Grade II-IV GVHD|The primary outcome of this study is the cumulative incidence of grade II-IV acute GVHD up to Day 180 after stem cell infusion. Acute GHVD is graded according to the modified Glucksberg criteria (adapted from Thomas et al., NEJM ,1975, pp. 895-90), which is based on criteria by which the provider classifies acute GVHD per its objective organ staging. Acute GVHD is assessed in weekly standard of care visits post stem cell infusion and is captured in the protocol EDC upon evaluation of clinical notes up to Day 100. Data for acute GVHD organ staging and etiologies are collected in an acute GVHD separate case report form and do not include system organ class, expectedness or attribution.|6 months||||Percentage of participants||95% Confidence Interval|Number
2640482|NCT01754376|Secondary|Ratio of CD8+ T Cells to Regulatory T Cells|Tumor samples were collected pre-treatment, after 1-2 weeks on vemurafenib alone and after administration of aldesleukin (high-dose interleukin 2, HD-IL2). Multi-parameter flow cytometry was performed to measure the frequency of regulatory T cells and of CD8+ T cells. The CD8/Treg ratio was calculated.|Up to 8 weeks from start of treatment|Tumor tissue was only analyzed from one participant|||ratio CD8/T reg cells|||Number
2640483|NCT01754376|Secondary|Mean Percentage of Aldesleukin Doses Received Per Participant|To assess whether the number of doses of aldesleukin that can be safely administered is affected by the co-administration of vemurafenib. The total number of planned doses of aldesleukin was 28 in each of course 1 and course 2. A participant receiving all 28 doses in course 1 would be considered as receiving 100 percent of doses.|Approximately 9 months from start of treatment|Six participants started course 1. Only 4 participants started course 2.|||percentage of doses||Full Range|Mean
2640484|NCT01754376|Secondary|Number of Participants Experiencing Grade 3 (Severe) Adverse Events|To determine the toxicity and safety of concurrent administration of aldesleukin and vemurafenib by assessing adverse events experienced by participants.|2 years||||Participants|||Count of Participants
2640485|NCT01754376|Secondary|Overall Survival|To determine the overall survival in patients treated with aldesleukin and vemurafenib. Overall survival is defined as the time between the first administration of study drug and death due to any cause.|2 years|Median overall survival was not reached|||months||Full Range|Median
2640486|NCT01754376|Secondary|Overall Response Rate|To determine the overall response rate (as defined as the rate of objective response (Complete Response (CR) or Partial Response (PR)) lasting continuously for 12 or more months, and beginning at any point within 12 months of initiating therapy) in patients treated with aldesleukin and vemurafenib. In this limited cohort, response rate was calculated as the proportion of patients with partial (PR) or complete response (CR) divided by the total number of patients treated. Per Response Evaluation Criteria in Solid Tumors (RECIST v.1.1), 'Complete Response' is the disappearance of all target lesions and 'Partial Response' is at least a 30% decrease in the sum of the diameters of target lesions, as measured via CT (computed tomography). Overally Response (OR) = CR + PR.|2 years||||percentage of participants||95% Confidence Interval|Number
2640487|NCT01754376|Primary|Progression Free Survival|To assess the efficacy (as measured by progression-free survival (PFS)) of patients with metastatic melanoma with V600E mutation treated with the combination of vemurafenib and aldesleukin. Progression free survival is defined as the time between the first dose of study drug and the first occurrence of progression of disease or death from any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v.1.1), as at least a 20% increase in the sum of the diameters of target lesions or the appearance of one or more new lesions.|3 years||||weeks||95% Confidence Interval|Median
2640488|NCT01754259|Secondary|Change in LV Diastolic Function|Change (from baseline) in LV diastolic function reflected primarily in mitral annular early diastolic relaxation velocity (E') at 4 weeks post randomization. LV end-diastolic and end-systolic volumes (used to calculate LVEF), left atrial volume, septal and lateral peak early diastolic tissue velocity (e'), septal and lateral peak systolic tissue velocity (s'), and mitral inflow velocity (E) were all measured in accordance with ASE guidelines.|4 weeks||||% change|||Number
2640489|NCT01754259|Primary|Change in Post-exercise Coronary Vasodilator Reserve|Change (from baseline) in post-exercise coronary vasodilator reserve, as measured by PET imaging at 4 weeks post randomization. Per-patient global coronary flow reserve (CFR) was calculated as the ratio of absolute MBF at stress over rest for the entire left ventricle. Quantitation of MBF was performed by two operators blinded to patient, treatment period and treatment order.|4 weeks||||% change|||Number
2640490|NCT01754194|Secondary|Surgical Complications|Incidence of procedural and post-procedural complications through 30 days post-op.|30 Days||||participants|||Number
2640491|NCT01754194|Secondary|Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization||12 Months||||percentage of patients|||Number
2640492|NCT01754194|Secondary|Health Resource Utilization - Recovery Time From Surgery||12 months||||Days||Standard Deviation|Mean
2640493|NCT01754194|Secondary|Health Resource Utilization - Durantion of Sugery||12 Months||||Minutes||Standard Deviation|Mean
2640494|NCT01754194|Secondary|Excess Weight Loss (EWL)|"EWL, calculated as a percentage, was used to compare weight loss between patients or types of bariatric procedures instead of actual weight loss.~The formula used was: EWL = 100 × actual weight loss (lbs)/(initial weight [lbs] - IBW [lbs]), where Actual weight loss was calculated as the difference between initial/pre-operative weight (lbs) and post-operative weight (lbs) and IBW was based on the 1983 Metropolitan Height (inches) and Weight (lbs). The Aurea Under the Curve (AUC) of EWL is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the more the patient lost weight."|12 Months||||Percentage EWL*month||Standard Deviation|Mean
2640495|NCT01754194|Primary|Quality of Life (QOL) in First Postoperative Year According to Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite)|The IWQoL-Lite consists of five domains: physical function (11 items), self-esteem (7 items), sexual life (4 items), public distress (5 items), and work (4 items). Each item has five response options: never true-1, rarely true-2, sometimes true-3, usually true-4, and always true-5. In computing raw and normalized scores, a pro-rated system is used for handling missing data. Normalized scores are used to obtain scores ranging from 0 (worst QoL) to 100 (best QoL). The Aurea Under the Curve (AUC) of QOL as assessed by IWQOL-Lite questionnaire is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the better the patient is.|12 months||||Score*months||Standard Deviation|Mean
2640496|NCT01754194|Primary|Quality of Life (QOL) in First Postoperative Year According to Bariatric Analysis and Reporting System (BAROS) With the Moorehead-Ardelt Quality of Life Questionnaire II (M-A QoLQ II)|The BAROS consists of a scoring table that includes three main areas of analysis: weight loss, improvement of medical conditions and M-A QoLQ II. Points are added or subtracted according to changes in these domains. A maximum of three points is given to each domain to evaluate changes after medical or surgical intervention. Points are deducted for complications or reoperations. The M-A QoLQ II assesses six important QoL items (self-esteem, physical activity, social life, work conditions, sexual activity and eating behaviour) on a scale ranging from -0.50 to 0.50 with 0.10 increments to assess each item. The total number of points (range -7 to 9) defines five outcome groups from failure to excellent. The Aurea Under the Curve (AUC) of QOL as assessed by BAROS with M-A QoLQ II is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the better the patient is.|12 months||||Score*months||Standard Deviation|Mean
2640497|NCT01754194|Primary|Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)|The EQ-5D-5L (minimum and maximum values are 0 and 1 respectively) consists of two sections,the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D descriptive system comprises the following five dimensions: mobility,self-care,usual activities (e.g.,work, study..), pain/discomfort and anxiety/depression with five response levels for each dimension:no problems,slight problems, moderate problems,severe problems and extreme problems.The EQ-5D VAS is a 20 cm vertical scale where patients can mark from 0 (worst health imaginable) to 100 (best health imaginable).The global score at each timepoint is calculated as a composite of the five dimention score and of the VAS health score according to a specific algorithm.The Aurea Under the Curve (AUC) of QOL as assessed by EQ-5D-5L is reported to combine repeated measurements at flexible time intervals between 0 and 12 months post-procedure into a single numeric value.The higher the AUC value is,the better the patient is.|12 Months||||Score*months||Standard Deviation|Mean
2640498|NCT01754129|Secondary|DUODOPA Total Daily Infusion Dosage|The total daily DUODOPA infusion dosage was documented at study visits starting at the baseline visit. One mL of DUODOPA contains 20 mg levodopa and 5 mg carbidopa monohydrate.|Baseline, Visit 1, Visit 2, (Year 1) and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit|||mL||Standard Deviation|Mean
2640499|NCT01754129|Secondary|Participant Self-assessment Scale of DUODOPA Therapy|Participants were asked to rate DUODOPA therapy on a scale from 0 to 10 (0-2 worse, 3-5, unsatisfactory, 6-8 satisfactory, 9-10, very good).|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit|||units on a scale||Standard Deviation|Mean
2640500|NCT01754129|Secondary|Change in Global Effectiveness on Motor Symptoms as Compared to Baseline|Motor symptoms were rated by neurologists using three categories: improvement, no change, or worsening as compared to symptoms present at baseline.|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit|||Participants|||Count of Participants
2640520|NCT01753856|Secondary|Percentage of Osteoid Volume (OV)/Bone Volume (BV) in the CC of the Iliac Crest|OV is the percentage of a given volume of bone tissue that consists of new unmineralized bone matrix (osteoid). Percentage = (OV/BV) *100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an assessment of OV/BV in the CC of the iliac crest.|||percentage of BV||Inter-Quartile Range|Median
2640501|NCT01754129|Secondary|Concomitant Diseases and Medications|Concomitant diseases were coded using the MedDRA dictionary (version 15.1). Concomitant diseases present in ≥ 5% of participants started before or at Visit 1 and stopped after Visit 1 or ongoing or started after Visit 1 are presented. Non-PD medications in ≥ 5% of participants maintained with a start date previous to the date of Visit 1 and a stop date after date of Visit 1 or ongoing are listed.|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|All enrolled participants from the screened population with all inclusion/exclusion criteria met|||Participants|||Count of Participants
2640502|NCT01754129|Secondary|Change in Relative Stress Scale (RSS) Scores|The Relative Stress Scale is a 15-item questionnaire completed by family caregivers to assess personal distress, life upset, and negative feelings regarding caring for a family member with PD. Scores on each item range from 1 (not at all) to 5 (to a high degree). The RSS total score ranges from 15 (low stress) to 75 (severe stress). Negative changes from baseline indicate improvement.|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.|||units on a scale||95% Confidence Interval|Mean
2640503|NCT01754129|Secondary|Economic and Social Impact of Family-provided Healthcare|Family caregivers were surveyed regarding the participant's need for home health care for Parkinson's Disease; the amount of time dedicated to care each week; the need of a family caregiver to reduce or change their normal work hours in order to provide care; the number of working days per month spent performing caregiver responsibilities; the number of hours of professional assistance per week needed; and the hourly costs of professional assistance incurred per week.|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit|||hours||Standard Deviation|Mean
2640504|NCT01754129|Secondary|Change in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) Scores|The Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale is a 28-item survey used to assess the frequency and severity of behaviors including gambling, sexual behavior, buying, eating, performing tasks or hobbies, repeating simple activities, and PD medication use. Scores on each item range from 0 (never) to 4 (very often). The QUIP-RS total score ranges from 0 (normal function) to 112 (severely impaired function). Negative changes from baseline indicate improvement.|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.|||units on a scale||95% Confidence Interval|Mean
2640505|NCT01754129|Secondary|Change in Gait and Falls Questionnaire (GFQ) Scores|The Gait and Falls questionnaire (GFQ) is a self-administered 16-item questionnaire addressing gait in daily living, the frequency and severity of freezing of gait, the frequency of festinating gait and its relation to falls, and the frequency and severity of falls. Scores on each item range from 0 (no symptoms) to 4 (severe symptoms). The GFQ total score ranges from 0 (normal function) to 64 (severely impaired function). Negative changes from baseline indicate improvement.|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.|||units on a scale||95% Confidence Interval|Mean
2640506|NCT01754129|Secondary|Change in Parkinson's Disease Sleep Scale Version 2 (PDSS-2) Scores|The Parkinson's Disease Sleep Scale version 2 (PDSS-2) is a self-administered 15-item questionnaire addressing sleep and nocturnal disturbances in PD, including sleep quality, difficulty falling and staying asleep, restlessness, pain, or muscle cramps in legs or arms, dreams or hallucinations, getting up at night to pass urine, immobility at night, painful posturing in the morning, tremor on waking, sleepiness upon waking, and snoring or breathing difficulties. Scores on each item range from 0 (never) to 4 (very frequent). The PDSS-2 total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance). Negative changes from baseline indicate improvement.|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.|||units on a scale||95% Confidence Interval|Mean
2640507|NCT01754129|Secondary|Change in Parkinson's Disease Quality of Life Questionnaire (PDQ-39) Scores|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in PD. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The total score is between 0 and 156, calculated as the total sum of the items, and higher scores are associated with more severe symptoms. Negative changes from baseline indicate improvement.|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.|||units on a scale||95% Confidence Interval|Mean
2640508|NCT01754129|Secondary|Change in Unified Parkinson's Disease Rating Scale on Mentation, Behavior and Mood (UPDRS I) and Activities of Daily Living (UPDRS II) During On and Off Phases|"The UPDRS is an Investigator-used rating tool to follow the course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0 to 16 and higher scores are associated with more disability. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. Scores for both On time (when PD symptoms are well-controlled by the drug) and Off time (when PD symptoms are not adequately controlled by the drug) are presented. Negative changes from baseline indicate improvement."|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.|||units on a scale||95% Confidence Interval|Mean
2640555|NCT01753557|Secondary|Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)||4 weeks||||percentage of subjects achieving RVR||95% Confidence Interval|Number
2640556|NCT01753557|Primary|Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||48 weeks||||percentage of subjects achieving SVR||95% Confidence Interval|Number
2641090|NCT01749956|Secondary|Overall Survival|Measured from date of first protocol treatment until date of death.|Every 3 months (±1 month) following documented progression, up to 5 years or death, whichever comes first.||||participants||95% Confidence Interval|Median
2640509|NCT01754129|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Part A+B Score: Mean Change From Baseline to Visits 2 and 3|"The UPDRS is an Investigator-used rating tool to follow the course of Parkinson's disease. Scores for dyskinesias, early-morning dystonia, and clinical fluctuations (off times when PD symptoms are not adequately controlled by the drug) were assessed by the sum of the Part A+B items, questions 32-39. Questions 32-34 and 39 are measured on a 5-point scale (0-4), with 0 being no disease and 4 representing severe disease. Higher scores indicate a greater duration of dyskinesia (Q32), disability (Q33), and pain (Q34), and proportion of the waking day spent in off (Q39). Questions 35-38 are scored on a binary scale where 0= no and 1=yes, with higher scores indicating a higher incidence of early morning dystonia, and a higher degree of clinical fluctuations. The total score ranges from 0 (normal) to 20 (severe disease). Negative changes from baseline indicate improvement."|Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.|||units on a scale||95% Confidence Interval|Mean
2640510|NCT01754129|Primary|"Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 39 (Proportion of Waking Day Spent in Off) Score: Mean Change From Baseline to the Last Available Follow up"|"Section B of the UPDRS IV questionnaire consists of 4 individual items that assess the degree of clinical fluctuations. Item 39 is the percentage of off times (when PD symptoms are not adequately controlled by the drug) during the waking day. The Item 39 score ranges from 0 (None), 1 (1- 25% of the waking day), 2 (26 - 50% of the waking day), 3 (51 - 75% of the waking day), and 4 (76 - 100% of the waking day). The mean change from baseline was calculated as the score at the last available follow up visit minus the score at baseline/Visit 1. Negative change from baseline for off time indicates improvement."|Baseline/Visit 1 and Visit 2 (Year 1) or Visit 3 (Year 2)|Evaluable population: participants with at least one post-baseline visit. Missing data at Visit 3 was replaced using Last Observation Carried Forward technique.|||units on a scale||95% Confidence Interval|Mean
2640511|NCT01753999|Secondary|CPAP Efficacy|Efficacy will be evaluated by measuring the residual apnea and hypopnea index (AHI) while on treatment. The efficacy of standard CPAP and CPAP-flex will be compared. Results are based on both treatment periods.|9 weeks after initiation of treatment|Subjects who received the allocated treatment (i.e., turned on the PAP device; N=239 for CPAP and N=249 for CPAP Flex). An additional 82 subjects on CPAP and 102 subjects on CPAP-Flex were not analyzed as an AHI could not be generated during the analysis period due to insufficient use.|||events/hour||Standard Deviation|Mean
2640512|NCT01753999|Secondary|CPAP Efficacy|Efficacy will be evaluated by measuring the residual apnea and hypopnea index (AHI) while on treatment. The efficacy of standard CPAP and CPAP-flex will be compared. Results are based on the first treatment period only (pre-crossover).|5 weeks after initiation of treatment|Subjects who received treatment (turned on the PAP device). An additional 48 subjects on CPAP and 53 on CPAP-FLex were not analyzed as an AHI could not be generated during the analysis period due to insufficient use.|||Events/hour||Standard Deviation|Mean
2640513|NCT01753999|Primary|Adherence to CPAP Overall Study|The use (number of hours per night) will be compared between standard CPAP and CPAP flex. Results are based on both periods.|9 weeks after initiation of treatment|Subjects who received the allocated treatment (i.e., turned on the PAP device) in either the first treatment period or the second treatment period.|||Hours/night||Inter-Quartile Range|Median
2640514|NCT01753999|Primary|Adherence to CPAP Pre-crossover|The use (number of hours per night) will be compared between standard CPAP and CPAP flex. Results are based on the first treatment period only (pre-crossover).|5 weeks after initiation of treatment|Subjects who received the allocated treatment (i.e., turned on the PAP device). The difference between the number allocated and the number of analyzed is the result of some subjects (n=11 in CPAP and n=16 in C-Flex) who did not turn on the device despite taking it home. These were assumed to have NOT received the allocated treatment.|||Hours/night||Inter-Quartile Range|Median
2640515|NCT01753856|Secondary|Percentage of Eroded Surface/Bone Surface (ES/BS) in the CC, EC and IC of the Iliac Crest|ES/BS is the fraction of the entire trabecular surface occupied by resorption bays, including both those with and without osteoclasts. It is an indicator of bone resorption. Percentage = (ES/BS) *100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with ES/BS assessed in the CC, EC and IC of the iliac crest.|||percentage of BS||Inter-Quartile Range|Median
2640516|NCT01753856|Secondary|Wall Thickness (W.Th) in the CC, EC and IC of the Iliac Crest|W.Th is the distance from the cement line to the marrow space of completed trabecular bone packets.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with a W. Th assessment in the CC, EC and IC of the iliac crest.|||µm||Inter-Quartile Range|Median
2640517|NCT01753856|Other Pre-specified|Average Length of DLs in the CC, EC, IC and PC of the Iliac Crest|The length of TET DLs is a measure of the extent of bone formation in each compartment within individual remodeling units and is measured in mm. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an assessment of DL length in the various compartments of the iliac crest.|||mm||Standard Deviation|Mean
2640518|NCT01753856|Secondary|Osteoid Thickness (O.Th) in the CC, EC and IC of the Iliac Crest|O.Th is a measure of the average thickness of osteoid seams.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an O.Th assessment in the CC, EC and IC of the iliac crest.|||micrometers (mcm)||Inter-Quartile Range|Median
2640519|NCT01753856|Secondary|Percentage of Osteoid Surface (OS)/Bone Surface (BS) in the CC, EC and IC of the Iliac Crest|OS is the percentage of the entire trabecular BS that is covered by osteoid. Percentage = (OS / BS) *100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with the assessment of OS/BS in the CC, EC and IC of the iliac crest.|||percentage of BS||Inter-Quartile Range|Median
2640521|NCT01753856|Secondary|Adjusted Apposition Rate (Aj.AR) in the CC, EC and IC of the Iliac Crest|Aj.AR is MAR averaged over the entire osteoid surface and in a steady state is an estimate of the mean rate of matrix apposition. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggested suppression of bone formation. BFR = MAR * (MS/BS). SL cases were imputed to a value of 0.3 µm/day or counted as missing. NL cases were counted as missing.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with Aj.AR assessments in the CC, EC and IC of the iliac crest.|||µm/day||Inter-Quartile Range|Median
2640522|NCT01753856|Secondary|Activation Frequency (Ac.f) in the CC, EC and IC of the Iliac Crest|Ac.f is the probability of new remodeling cycles initiated on the BS per year. Ac.f = (BFR/BS) / wall thickness. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggests suppression of bone formation. SL cases were imputed to a value of 0.3 µm/day or counted as missing. NL cases were assigned a value of zero.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with Ac.f assessments in the CC, EC and IC of the iliac crest.|||new cycles per year||Inter-Quartile Range|Median
2640523|NCT01753856|Secondary|Percentage Change From Baseline to 1, 3, and 6 Months in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX)|CTX is a marker of bone turnover and is a measure of bone resorption. Percentage = (CTX value at specified time points - CTX value at baseline) / (CTX value at baseline) * 100.|Baseline, 1, 3, and 6 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and serum CTX measured at baseline and the specified time points.|||percentage change in CTX||Inter-Quartile Range|Median
2640524|NCT01753856|Secondary|Percentage Change From Baseline to 1, 3, and 6 Months in Serum Osteocalcin|Osteocalcin is a marker of bone turnover and a measure of osteoblast function. Percentage = (osteocalcin value at specified time points - osteocalcin value at baseline) / (osteocalcin value at baseline) * 100.|Baseline, 1, 3, and 6 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had serum osteocalcin measured at baseline and the specified time points.|||percentage change in osteocalcin||Inter-Quartile Range|Median
2640525|NCT01753856|Secondary|Percentage Change From Baseline to 1, 3, and 6 Months in Serum Procollagen Type I N-terminal Propeptide (P1NP)|P1NP is a marker of bone turnover and is a measure of bone formation. Percentage = (P1NP value at specified time points - P1NP value at baseline) / P1NP value at baseline * 100.|Baseline, 1, 3, and 6 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had serum P1NP measurements at baseline and the specified time points.|||percentage change in P1NP||Inter-Quartile Range|Median
2640526|NCT01753856|Secondary|Percentage Change From Baseline to 1, 3, and 6 Months in Intact Parathyroid Hormone (PTH)|PTH regulates calcium and phosphate metabolism in bone and kidney, and is typically measured in serum using the intact PTH assay. Percentage = (PTH value at specified time points - PTH value at baseline) / PTH value at baseline * 100.|Baseline, 1, 3, and 6 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had serum PTH assessed at baseline and the specified time points.|||percentage change in PTH||Inter-Quartile Range|Median
2640527|NCT01753856|Secondary|Percentage of Single or Double Tetracycline Labels Per Bone Surface (sLS/BS or dLS/BS) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies|At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggested suppression of bone formation. Percentage = (Single or double TET labels / BS) *100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with label surface measured in the specified compartments of the iliac crest.|||percentage of TET label||Inter-Quartile Range|Median
2640528|NCT01753856|Secondary|Change From Baseline to 3 Months in Bone Formation Rate/Bone Surface (BFR/BS ) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies|BFR/BS is the volume of mineralized bone formed per unit surface of bone per unit of time [mm cubed per mm squared per year (mm³/mm²/year)]. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicates active bone formation, a SL or NL suggests suppression of bone formation. BFR = MAR * (MS/BS). SL cases were imputed to a value of 0.3 mcm/day or counted as missing. NL cases were assigned a value of zero.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with BFR/BS assessments in the specified compartments of the iliac crest.|||mm³/mm²/year||Inter-Quartile Range|Median
2640529|NCT01753856|Secondary|Change From Baseline to 3 Months in Mineral Apposition Rate (MAR) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies|MAR is a measure of the linear rate of production of mineralized bone matrix by osteoblasts and is measured by the mean distance between 2 consecutive labels divided by the time interval. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation, and a SL or NL suggested suppression of bone formation. SL cases were imputed to a value of 0.3 micrometers per day (µm/day) or counted as missing. NL cases were reported as missing.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an evaluation of MAR in the CC, EC, IC and PC of the iliac crest.|||mcm/day||Inter-Quartile Range|Median
2640530|NCT01753856|Secondary|Change From Baseline to 3 Months in Label Length Within Each Basic Multicellular Unit (BMU) in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies|BMUs are local groups of osteoblasts and osteoclasts that act in concert to complete a single remodeling cycle. The label length is a measure of the extent of the mineralization front within each BMU in the CC, EC, IC and PC. At baseline (18 days prior to randomization / study drug administration), DEM was administered. 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation, and a SL or NL suggested suppression of bone formation.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with label lengths measured in the specified compartments of the iliac crest.|||millimeters (mm)||Inter-Quartile Range|Median
2640531|NCT01753856|Secondary|Percentage of Overfilled Remodeling Sites in the CC, EC and PC of the Iliac Crest Bone Biopsies|The percentage of overfilled remodeling sites in the CC, EC, and PC were defined as the percentage of observed remodeling units in which the second DL (TET) extended beyond the limits of the scalloped reversal line and into the adjacent, previously unresorbed surface of the bone. Percentage = (overfilled remodeling bone formation unit / total bone formation unit) * 100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy evaluated for overfilled remodeling sites in the specified compartments of the iliac crest.|||percentage of overfilled remodeling site||Inter-Quartile Range|Median
2640532|NCT01753856|Secondary|Percentage of Mineralizing Surface With Remodeling-Based Formation and Modeling-Based Formation in the CC, EC and PC of the Iliac Crest Bone Biopsies|"The percentage of mineralizing surface where post-treatment DLs in the CC, EC, and PC were classified as remodeling-based or modeling based bone formation based on collagen fiber orientation and whether the underlying reversal line was scalloped or smooth.~Percentage = percentage remodeling- or modeling-based formation units * MS/BS"|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with the classification of TET DLs as remodeling- or modeling-based formation in the specified compartments of the iliac crest.|||percentage of the total formation unit||Full Range|Median
2640533|NCT01753856|Secondary|Percentage of Bone With Remodeling-Based and Modeling-Based Formations in the CC, EC and PC of the Iliac Crest Bone Biopsies|In this study, post-treatment DLs in the CC, EC, and PC were classified as remodeling-based or modeling-based bone formations which was determined by whether the underlying reversal line was scalloped or smooth and by the collagen fiber orientation. Percentage = (remodeling-based formation units or modeling-based formation units/ total bone formation units) * 100.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with the classification of TET DLs as remodeling-based or modeling-based formation in the specified compartments of the iliac crest.|||percentage of the total formation unit||Inter-Quartile Range|Median
2640534|NCT01753856|Secondary|MS/BS in the CC, EC, IC and PC of the Iliac Crest Bone Biopsies 3 Months Post First Dose of Study Drug|MS /BS is a measure of the proportion of BS on which new mineralized bone is deposited at the time of DEM or TET labeling and is calculated as the sum of the total extent of DL plus half the extent of SL divided by BS. At baseline (18 days prior to randomization / study drug administration), DEM was administered (3 days on, 12 days off, 3 days on). 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered (same dosing schedule as DEM). Both DEM and TET temporarily bind to new bone and fluoresce under UV light. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggested varying degrees of suppression of bone formation.|3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with MS/BS measurements in the specified compartments of the iliac crest.|||percentage of BS||Inter-Quartile Range|Median
2640535|NCT01753856|Secondary|Change From Baseline to 3 Months in MS/BS in the Endocortical Compartment (EC), Intracortical Compartment (IC), and Periosteal Compartment (PC) of the Iliac Crest Bone Biopsies|MS /BS is a measure of the proportion of BS on which new mineralized bone is deposited at the time of DEM or TET labeling and is calculated as the sum of the total extent of DL plus half the extent of SL divided by BS. At baseline (18 days prior to randomization / study drug administration), DEM was administered (3 days on, 12 days off, 3 days on). 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered (same dosing schedule as DEM). Both DEM and TET temporarily bind to new bone and fluoresce under UV light. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or NL suggested varying degrees of suppression of bone formation.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with MS/BS measurements in the specified compartments of the iliac crest.|||percentage of BS||Inter-Quartile Range|Median
2640536|NCT01753856|Secondary|Number of Samples With Single or Double Tetracycline Labels, SL and DL, or No Tetracycline Labels in the CC, Endocortical Compartment (EC), Intracortical Compartment (IC) and Periosteal Compartment (PC) of the Iliac Crest Bone Biopsies||3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with an assessment of the number of samples with specified labels in the various compartments of the iliac crest.|||Samples|||Number
2640569|NCT01753401|Secondary|Krupp Fatigue Severity Score (FSS) at Week 52|"The Krupp FSS is a scale to rate disability-related fatigue. Respondents use a scale ranging from 1 (completely disagree) to 7 (completely agree) to indicate their agreement with nine statements about fatigue. A visual analogue scale is also included with the scale; respondents are asked to denote the severity of their fatigue over the past 2 weeks by placing a mark on a line extending from no fatigue to fatigue as bad as could be. Higher scores on the scale are indicative of more severe fatigue.~This validated fatigue severity scale measures impact of fatigue with a 9-item questionnaire, with a 7-point Likert scale for each question. Total score ranges from 0 (best possible outcome) to 63 (worst possible fatigue)."|at Week 52|mITT with necessary data at Week 52|||score on a scale||Standard Deviation|Mean
2640537|NCT01753856|Primary|Change From Baseline to 3 Months in Mineralizing Surface (MS) /Bone Surface (BS) in the Cancellous Compartment (CC) of the Iliac Crest Bone Biopsies|MS /BS is a measure of the proportion of BS on which new mineralized bone is deposited at the time of DEM or TET labeling, and calculated as the sum of the total extent of double label (DL) plus half the extent of single label (SL) divided by BS. At baseline (18 days prior to randomization / study drug administration), DEM was administered (3 days on, 12 days off, 3 days on). 22 days prior to the biopsy procedure (biopsy obtained 3 months post first dose of study drug), TET was administered (same dosing schedule as DEM). Both DEM and TET temporarily bind to new bone and fluoresce under UV light. New bone in the biopsy was seen as the amount of bone between the 2 fluorescently DEM- or TET-labeled lines under a microscope. A DL indicated active bone formation and a SL or no label (NL) suggested varying degrees of suppression of bone formation.|Baseline, 3 months post first dose of study drug|Randomized participants who received at least 1 dose of study drug and had an evaluable 3-month bone biopsy with MS/BS measurements in the CC of the iliac crest.|||percentage of BS||Inter-Quartile Range|Median
2640538|NCT01753713|Other Pre-specified|Changes From Baseline in Circulating Growth Factors and Soluble Receptors.|To assess the pharmacodynamic effect of dovitinib on potential plasma biomarkers that may include measuring concentrations of circulating, microparticles, PlGF, PDGF-AA, PDGF-AB, PDGF-BB, SDF-la, thrombospondin-l, Angl, and 11-6, IL-8 and FGF.|Up to 30 days after treatment|||||||
2640539|NCT01753713|Secondary|Overall Survival|The Kaplan-Meier method will be used. Overall survival is defined as the time from randomization to death.|to death, approximately 2 years||||Months||95% Confidence Interval|Median
2640540|NCT01753713|Secondary|Median Progression Free Survival|The progression- free survival (PFS) at 6 months is defined as the time from randomization to objective tumor progression or death. So patients who have CR, PR or SD at 6 months will constitute PFS-6|6 months||||Months||95% Confidence Interval|Median
2640541|NCT01753713|Secondary|Objective Response Rate Using Modified Revised Assessment in Neuro-Oncology (RANO) Criteria|Number of patients (both populations) with a complete response (CR-no measurable disease), partial response (PR >50% reduction in measurable disease), minor response (MR >25% reduction of measurable disease), stable disease (SD <25% reduction) and progressive disease (PD >25% measurable disease and new lesions).|Up to 30 days after treatment||||Participants|||Count of Participants
2640542|NCT01753713|Secondary|Toxicity Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Number of adverse events in patients in both populations (grade 1-5). Grade 1 are defined as mild events characterized as asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention indicated. Grade 2 are moderate events with minimal, local or non invasive interventions indicated. Grade 3 are severe or medically significant events but not immediately life-threatening; hospitalization indicated. Grade 4 are life-threatening consequences with urgent intervention indicated. Grade 5 are deaths related to events|Assessed until 30 days after treatment up to 32 weeks||||Events|||Number
2640543|NCT01753713|Primary|Arm 2: Determine Median Time to Progression|Anti-angiogenic therapy (including anti-VEGF therapy or bevacizumab) patients with recurrent glioblastoma (GBM). Time to tumor progression (TTP), is defined as the time from randomization to time of progressive disease. So it is ongoing and will be assessed every 8 weeks …8, 16, 24, 32 …week. Progression is defined as >25% increase in size of lesions or evidence of new lesions|From randomization to time of progression every 8 weeks (2 cycles of treatment) up to 32 weeks||||Months||95% Confidence Interval|Median
2640544|NCT01753713|Primary|Arm 1: Progression Free Survival (PFS)|Number of anti-angiogenic therapy (including anti-VEGF therapy or bevacizumab) naive patients with recurrent glioblastoma (GBM). The progression- free survival (PFS) at 6 months is defined as the time from randomization to objective tumor progression or death. So patients who have CR, PR or SD at 6 months will constitute PFS-6. Progression is defined using the Response Assessment in Neuro-Oncology (RANO) Criteria where CR = Total disappearance of lesions, PR = >50% reduction in lesions and SD = <25% reduction in lesions|6 months||||Participants|||Count of Participants
2640545|NCT01753570|Secondary|Number of Participants With the Emergence of Resistance-associated Variants After MP-424 Administration at the Non-structural 3 Protease Region of HCV.|To examine the emergence of resistance-associated variants after MP-424 administration.|From baseline to 24 weeks after completion of drug administration|“Overall number of participants analyzed” indicates the number of participants who did not achieve SVR and detected HCV RNA as positive at the last visit in each group, MP-424+RBV+IFN Beta, Genotype1 and MP-424+RBV+IFN Beta, Genotype2.|||participants|||Number
2640546|NCT01753570|Secondary|Transition of Serum HCV RNA Levels||Baseline，Day2，Day3，1Week，2Weeks，3Weeks，4Weeks，12Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks|Participants were excluded from analysis because of dropouts or missing data.|||log IU/mL||Inter-Quartile Range|Median
2640547|NCT01753570|Secondary|Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration||60 weeks(RBV+IFN beta), 36 weeks(MP-424+RBV+IFN beta)||||percentage of subjects achieving SVR12||95% Confidence Interval|Number
2640548|NCT01753570|Secondary|Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)||48 weeks(RBV+IFN beta), 24 weeks(MP-424+RBV+IFN beta)||||percentage of subjects achieving ETR||95% Confidence Interval|Number
2640549|NCT01753570|Secondary|Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)||4 weeks||||percentage of subjects achieving RVR||95% Confidence Interval|Number
2640550|NCT01753570|Primary|Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||72 weeks(RBV+IFN beta), 48 weeks(MP-424+RBV+IFN beta)||||percentage of subjects achieving SVR||95% Confidence Interval|Number
2640551|NCT01753557|Secondary|Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis)||From baseline to 24 weeks after completion of drug administration||||participants|||Number
2640552|NCT01753557|Secondary|Transition of Serum HCV RNA Levels||baseline，Day2，Day3，1Weeks，2Weeks，3Weeks，4Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks||||log IU/mL||Inter-Quartile Range|Median
2640553|NCT01753557|Secondary|Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration||36 weeks||||percentage of subjects achieving SVR12||95% Confidence Interval|Number
2640554|NCT01753557|Secondary|Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)||24 weeks||||percentage of subjects achieving ETR||95% Confidence Interval|Number
2640557|NCT01753518|Secondary|Cosmetic Outcome|The cosmetic outcome will be assessed by patients and a blinded observer at the 6 week postpartum/postoperative exam using the Patient Observer Scar Assessment Scale (POSAS). The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically. Each item of both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is '1', and corresponds to the situation of normal skin (normal pigmentation, no itching etc), and goes up to the worst imaginable. Besides the six items the 'Overall Opinion' of the scar quality is scored separately of both patients and observers. Again, a 10-point scale is used in which 10 corresponds to the worst imaginable scar.|Measured at 6 week postoperative appointment|Not all patients or observers completed the scales. For the six items on the patient scale, N=44:52, but the overall opinion responding was N=43:51. For the observer scale the number responding was N=43:52 for vascularity, thickness, pliability, and surface area. N=42:52 for pigmentation and relief; N=42:50 for overall opinion.|||units on a scale||Inter-Quartile Range|Mean
2640558|NCT01753518|Primary|Skin Closure Time, All Resident Levels|Measured for all resident education levels (1 to 4 years postgraduate).|Measured at the time of the procedure (day 1), approximately 1 hour after incision start|Intention-to-Treat|||minutes||Inter-Quartile Range|Median
2640559|NCT01753518|Secondary|Surgeon Satisfaction (Per Procedure)|"Surgeon satisfaction was assessed by a 3-question questionnaire immediately after performing the procedure. The questions were: How satisfied are you with the appearance of the skin incision? How willing are you to recommend this skin closure (whether it was staples or suture) to a patient? How willing are you to use this skin closure (whether it was staples or suture) for your next cesarean section? There were 5 possible responses to each question (not at all, not very, no opinion, somewhat, extremely), with not at all,' not very, and no opinion being a negative response, and somewhat and extremely  being a positive response. Categories reported were negative, (including no opinion), and positive."|Immediately after the procedure (day 1)|A satisfaction survey wasn't completed for all of the procedures (103 per arm), so the reporting population is 91 for the suture arm, and 96 for the staple arm.|||Surgeons reporting per category|||Number
2640560|NCT01753518|Secondary|Patient Satisfaction|Patient satisfaction was measured by questionnaire at the time of dismissal from the hospital and at their 6 week postpartum/postoperative exam. There were 4 questions: How satisfied are you with the appearance of your skin incision? How willing are you to recommend this same skin closure to a friend? How willing are you to have this same skin closure for your next cesarean section? What is your overall satisfaction with your surgical procedure, including the skin incision? For reporting purposes, possible answers for each item were grouped into negative (not at all, not very, or no opinion), or positive (somewhat or extremely).|At the time of dismissal (typically day 3 or 4) and at 6 weeks postoperative appointment|The reduction in the number of participants analyzed is due to not all participants completing the questionnaire, and all the questions. For appearance of incision, N=58:69. For willingness to use treatment again, N=59:68.|||participants|||Number
2640561|NCT01753518|Secondary|Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic|Post-operative pain was assessed by pain medication use through chart review. These subjects required patient-controlled analgesia, or alternative oral analgesic, or a single dose of intravenous (IV) or intramuscular (IM) analgesic. Alternative oral analgesics included hydromorphone, hydrocodone/acetaminophen, or oxycodone/acetaminophen .|From day of procedure until end of hospital stay (typical dismissal on day 4)||||participants|||Number
2640562|NCT01753518|Secondary|Postoperative Pain|Post-operative pain was assessed by pain medication use through chart review.|From day of procedure until end of hospital stay (typical dismissal on day 4)||||mg||Inter-Quartile Range|Median
2640563|NCT01753518|Secondary|Participants With Postoperative Complications, by Type|Postoperative complications were assessed by chart review.|From the day of the procedure (Day 1) for 6 weeks|Participants could have experienced more than one type of postoperative complication. Note: wound dehiscence is a surgical complication in which a wound ruptures along surgical suture. A seroma is a pocket of clear serous fluid. A hematoma is a localized swelling that is filled with blood caused by a break in the wall of a blood vessel.|||participants|||Number
2640564|NCT01753518|Secondary|Total Number of Participants With Postoperative Complications|Postoperative complications were assessed by chart review.|From the day of the procedure (Day 1) for 6 weeks|The number of participants analyzed was reduced because some patients did not return for postpartum followup visits.|||participants|||Number
2640565|NCT01753518|Primary|Total Surgical Time, All Resident Levels|Total surgical time was defined as the time from incision start to incision completion. Measured for all resident education levels (1 to 4 years postgraduate).|Measured at the time of the procedure (day 1), approximately 1 hour after incision start|Intention-to-Treat|||minutes||Inter-Quartile Range|Median
2640566|NCT01753401|Secondary|Number of Participants With a Relapse Within 52 Weeks||within 52 weeks|mITT with necessary data at Week 52|||Participants|||Count of Participants
2640567|NCT01753401|Secondary|Mean Score on the Mental Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) at Week 52|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Higher scores indicate improvement.|at Week 52|mITT with necessary data at Week 52|||score on a scale||Standard Deviation|Mean
2640568|NCT01753401|Secondary|Mean Score on the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) at Week 52|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Higher scores indicate improvement.|at Week 52|mITT with necessary data at Week 52|||score on a scale||Standard Deviation|Mean
2640570|NCT01753401|Secondary|Cutaneous Lupus Activity as Measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) at Week 52|The CLASI consists of two scores the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI score ranges from 0 to 70, with higher scores indicating more severe skin disease.|at Week 52|mITT with necessary data at Week 52|||score on a scale||Standard Deviation|Mean
2640571|NCT01753401|Secondary|Number of Tender or Swollen Joints at Week 52|The doctor counted the number of tender or swollen joints at Week 52.|at Week 52|mITT with necessary data at Week 52|||Tender or Swollen Joints||Standard Deviation|Mean
2640572|NCT01753401|Secondary|Physician's Global Assessment (PGA) of Disease Severity at Week 52|PGA of disease severity on a 100 mm visual analogue scale are categorized to the following: 0 point (none) = 0 mm; 1 point (mild) = >0 - 33.33 mm; 2 points (moderate) = >33.33 - 66.67 mm; and 3 points (severe) = >66.67 - 100 mm. The count of participants in each category is reported.|at Week 52|mITT with necessary data at Week 52|||Participants|||Count of Participants
2640573|NCT01753401|Secondary|Score on the SELENA-SLEDAI at Week 52|"SLEDAI was modeled on the basis of clinician global judgment. A participant's SELENA-SLEDAI total score is the sum of all marked SLE-related descriptors on a checklist developed by the SELENA Group (also referred to as hybrid SLEDAI).~The scores of the descriptors range from 0 to 8. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity."|at Week 52|mITT with necessary data at Week 52|||score on a scale||Full Range|Median
2640574|NCT01753401|Secondary|Number of Participants Who Meet the Definition of a Responder at Week 52|"Participants are counted as responders based on:~decrease in SELENA-SLEDAI score from 4 to 0 for arthritis and no worsening in other organ systems based on BILAG~OR~decrease in SELENA-SLEDAI score from 2 to 0 for rash and no worsening in other organ systems based on BILAG"|at Week 52|mITT with necessary data at Week 52|||Participants|||Count of Participants
2640575|NCT01753401|Secondary|Mean Score on the Mental Component Scale (MCS) of the Short Form 36 Health Status Questionnaire (SF-36) Within 8 Weeks|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Higher scores indicate improvement.|at Baseline, Week 4 and Week 8 (within 8 weeks)|mITT|||score on a scale||Standard Deviation|Mean
2640576|NCT01753401|Secondary|Mean Score on the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) Within 8 Weeks|"The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Higher scores indicate improvement.~Rows: at Baseline, at Week 4, at Week 8"|at Baseline, Week 4 and Week 8 (within 8 weeks)|mITT|||score on a scale||Standard Deviation|Mean
2640577|NCT01753401|Secondary|Krupp Fatigue Severity Score (FSS) Within 8 Weeks|"The Krupp FSS is a scale to rate disability-related fatigue. Respondents use a scale ranging from 1 (completely disagree) to 7 (completely agree) to indicate their agreement with nine statements about fatigue. A visual analogue scale is also included with the scale; respondents are asked to denote the severity of their fatigue over the past 2 weeks by placing a mark on a line extending from no fatigue to fatigue as bad as could be. Higher scores on the scale are indicative of more severe fatigue.~This validated fatigue severity scale measures impact of fatigue with a 9-item questionnaire, with a 7-point Likert scale for each question. Total score ranges from 0 (best possible outcome) to 63 (worst possible fatigue).~Rows: at Baseline, at Week 4, at Week 8"|at Baseline, Week 4 and Week 8 (within 8 weeks)|mITT|||score on a scale||Standard Deviation|Mean
2640578|NCT01753401|Secondary|Cutaneous Lupus Activity as Measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Within 8 Weeks|"The CLASI consists of two scores the first summarizes the activity of the disease while the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and non-scarring alopecia. The CLASI score ranges from 0 to 70, with higher scores indicating more severe skin disease.~Rows: at Baseline, at Week 4, at Week 8"|at Baseline, Week 4 and Week 8 (within 8 weeks)|mITT|||score on a scale||Standard Deviation|Mean
2640579|NCT01753401|Secondary|Number of Tender or Swollen Joints Within 8 Weeks|The doctor counted the number of tender or swollen joints at Baseline, at Week 4, and at Week 8|at Baseline, Week 4, and Week 8 (within 8 weeks)|mITT|||Tender or Swollen Joints||Standard Deviation|Mean
2640580|NCT01753401|Secondary|Physician's Global Assessment (PGA) of Disease Severity at Week 8|PGA of disease severity on a 100 mm visual analogue scale are categorized to the following: 0 point (none) = 0 mm; 1 point (mild) = >0 - 33.33 mm; 2 points (moderate) = >33.33 - 66.67 mm; and 3 points (severe) = >66.67 - 100 mm. The count of participants in each category is reported.|at Week 8|mITT|||Participants|||Count of Participants
2640581|NCT01753401|Secondary|Physician's Global Assessment (PGA) of Disease Severity at Week 4|PGA of disease severity on a 100 mm visual analogue scale are categorized to the following: 0 point (none) = 0 mm; 1 point (mild) = >0 - 33.33 mm; 2 points (moderate) = >33.33 - 66.67 mm; and 3 points (severe) = >66.67 - 100 mm. The count of participants in each category is reported.|at Week 4|mITT|||Participants|||Count of Participants
2640582|NCT01753401|Secondary|Physician's Global Assessment (PGA) of Disease Severity at Baseline|PGA of disease severity on a 100 mm visual analogue scale are categorized to the following: 0 point (none) = 0 mm; 1 point (mild) = >0 - 33.33 mm; 2 points (moderate) = >33.33 - 66.67 mm; and 3 points (severe) = >66.67 - 100 mm. The count of participants in each category is reported.|at Baseline|mITT|||Participants|||Count of Participants
2640583|NCT01753401|Secondary|BILAG Total Score Within 8 Weeks|"The BILAG is a transitional index that captures changing severity of clinical manifestations that produces an overview of disease activity across eight systems.~The 8 systems are scored on a scale from 0=not present to 4=worse, for the 4 week period before the assessment. The lowest possible score is 0, and the highest possible score is 32. A higher score means the symptoms are worse.~Rows: Baseline, Week 4, Week 8"|within 8 weeks|mITT|||score on a scale||Standard Deviation|Mean
2640584|NCT01753401|Secondary|Score on the SELENA-SLEDAI Within 8 Weeks|"SLEDAI was modeled on the basis of clinician global judgment. A participant's SELENA-SLEDAI total score is the sum of all marked SLE-related descriptors on a checklist developed by the SELENA Group (also referred to as hybrid SLEDAI).~The scores of the descriptors range from 0 to 8. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.~Rows: Week 2, Week 4, Week 6, Week 8"|within 8 weeks|mITT|||score on a scale||Full Range|Median
2640585|NCT01753401|Secondary|Number of Participants Who Meet the Definition of a Responder Within 8 Weeks|"Participants are counted as responders based on:~decrease in SELENA-SLEDAI score from 4 to 0 for arthritis and no worsening in other organ systems based on BILAG~OR~decrease in SELENA-SLEDAI score from 2 to 0 for rash and no worsening in other organ systems based on BILAG"|within 8 weeks|mITT|||Participants|||Count of Participants
2640586|NCT01753401|Primary|Number of Participants Who Meet the Definition of a Responder Within 4 Weeks|"Participants are counted as responders based on two SLE indices: the Systemic Lupus Erythematosus Disease Activity Index amended by the SELENA group (SELENA-SLEDAI) and the British Isles Lupus Assessment Group (BILAG) Index.~decrease in SELENA-SLEDAI score from 4 to 0 for the arthritis descriptor (highest possible score is 4) and no worsening in other organ systems based on BILAG~OR~decrease in SELENA-SLEDAI score from 2 to 0 for rash (highest possible score is 2) and no worsening in other organ systems based on BILAG~The BILAG is a transitional index that captures changing severity of clinical manifestations. It has an ordinal scale scoring system by design that produces an overview of disease activity across eight systems. The individual system scores were not intended to be summated into a global score."|within 4 weeks|mITT|||Participants|||Count of Participants
2640587|NCT01753362|Secondary|Glucose Concentrations|Mean daily glucose concentrations at baseline and 26 weeks|26 weeks||||mg/dL||Standard Deviation|Mean
2640588|NCT01753362|Primary|HbA1c|The primary endpoint of the study is to detect a difference in HbA1c percent at baseline and after 26 weeks of treatment with Liraglutide or placebo.|26 weeks||||percent||Standard Deviation|Mean
2640589|NCT01753336|Secondary|TWSTRS Pain Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.|Mean TWSTRS pain subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS pain subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The pain subscale gives a score from 0 to 20, with higher values indicating greater pain experienced. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.|Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)|The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.|||units on a scale||Standard Deviation|Mean
2640590|NCT01753336|Secondary|TWSTRS Disability Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.|Mean TWSTRS disability subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean difference in the TWSTRS disability subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The disability subscale is a 6-item scale and each item is rated on a 6-point scale with higher values indicating the highest degree of disability. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.|Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)|The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.|||units on a scale||Standard Deviation|Mean
2640591|NCT01753336|Secondary|TWSTRS Severity Subscale Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.|Mean TWSTRS severity subscale scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS severity subscale scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for treatment cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The severity subscale gives a score from 0 to 35, with higher values indicating a worse outcome of physical findings of CD. The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.|Weeks 4 and 12 of treatment cycle 1, 2 and 3 (12 - 16 weeks duration each)|The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.|||units on a scale||Standard Deviation|Mean
2640602|NCT01753323|Secondary|AUC0-48h - Part 2|AUC0-48h was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.|||hr*ng/mL||Standard Error|Mean
2640936|NCT01751412|Secondary|Number of Participants With Acute Toxicities|Acute toxicities including pericarditis, pneumonitis, Lhermitte's, dermatitis, mucositis, esophagitis, leukopenia, xerostomia, and thrombocytopenia. Data is shown as the number of participants that experienced the given toxicities.|90 Days||||participants|||Number
2640592|NCT01753336|Secondary|Treatment Response in Treatment Cycle 3 Week 4.|Treatment response was defined as a reduction in the TWSTRS total score of at least 30% from pretreatment baseline to the Week 4 visit in Treatment Cycle 3. The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had previously received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had previously received placebo. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle. The proportion (percentage) of subjects who were treatment responders at Week 4 of Treatment Cycle 3 are presented.|Week 4 Treatment Cycle 3|The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit. For Treatment Cycle 3 there were 91 evaluable subjects.|||percentage of participants||95% Confidence Interval|Number
2640593|NCT01753336|Secondary|TWSTRS Total Scores at Pretreatment Baseline, Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.|The pretreatment baseline scores were defined as the TWSTRS measurement before Dysport® treatment in Study 169 for subjects who had received Dysport® in Study 169 and Day 1 of Study 170 for those subjects who had received placebo. Mean TWSTRS total scores for pretreatment baseline and for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from pretreatment baseline scores at Week 4 and Week 12 of each treatment cycle are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline for Studies 169 and 170 and at all post-treatment visits of each treatment cycle.|Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)|The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.|||units on a scale||Standard Deviation|Mean
2640594|NCT01753336|Primary|TWSTRS Total Score at Week 4 and Week 12 for Treatment Cycles 1, 2 and 3.|Mean TWSTRS total scores for Week 4 and Week 12 of treatment cycles 1, 2 and 3 are presented. The mean differences in the TWSTRS total scores from treatment cycle baseline (defined as Day 1 in each cycle) at the Week 4 and Week 12 visits for Treatment Cycles 1, 2 and 3 are also presented. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator at baseline and at all post-treatment visits of each treatment cycle.|Week 4 and 12 of treatment cycles 1, 2 and 3 (12 - 16 weeks duration each)|The safety population included all subjects who received at least 1 dose of study treatment, regardless of the amount of study treatment administered, and who had at least 1 safety record post-treatment or attended a post-treatment visit.|||units on a scale||Standard Deviation|Mean
2640595|NCT01753323|Secondary|Vz/F - Part 2|Vz/F was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.|||Liters||Standard Deviation|Mean
2640596|NCT01753323|Secondary|CL/F - Part 2|CL/F was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who who vomited before 3 hours.|||L/hr||Standard Deviation|Mean
2640597|NCT01753323|Secondary|T1/2 - Part 2|T1/2 was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.|||hours||Standard Deviation|Mean
2640598|NCT01753323|Secondary|Tmax - Part 2|Tmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.|||hours||Full Range|Median
2640599|NCT01753323|Secondary|Cmax - Part 2|Cmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.|||ng/mL||Standard Deviation|Mean
2640600|NCT01753323|Secondary|AUCinf - Part 2|AUCinf was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.|||hr*ng/mL||Standard Deviation|Mean
2640601|NCT01753323|Secondary|AUClast - Part 2|AUClast was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.|||hr*ng/mL||Standard Deviation|Mean
2640603|NCT01753323|Secondary|AUC0-24h - Part 2|AUC0-24h was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose.|Day 1|Pharmacokinetic (PK) analysis set analysis set for Cohort 3: The PK set for Cohort 3 included participants who received at least one dose of study medication except for 1 participant who was withdrawn on Day 1 and 3 participants who vomited before 3 hours.|||hr*ng/mL||Standard Error|Mean
2640604|NCT01753323|Secondary|Accumulation Ratio (Racc) (=AUC0-24h, day3/AUC0-24h, day1) - Part 1|Racc was analyzed using parent drug in plasma samples. On day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.|||ratio||Standard Deviation|Mean
2640605|NCT01753323|Secondary|Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) - Part 1|Vz/F was analyzed using parent drug in plasma samples. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.|||Liters||Standard Deviation|Mean
2640606|NCT01753323|Secondary|Clearance (CL/F ) - Part 1|CL/F was analyzed using parent drug in plasma samples. On day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.|||L/hr||Standard Deviation|Mean
2640607|NCT01753323|Secondary|Half-life (T1/2) - Part 1|T1/2 was analyzed using parent drug in plasma samples. On day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.|||hr||Standard Deviation|Mean
2640608|NCT01753323|Secondary|Area Under the Curve (AUC)Inf - Part 1|AUCinf was analyzed using parent drug in plasma samples. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.|||hr*ng/mL||Standard Deviation|Mean
2640609|NCT01753323|Secondary|Area Under the Curve (AUC)Last - Part 1|AUClast was analyzed using parent drug in plasma samples. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Day 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.|||hr*ng/mL||Standard Error|Mean
2640610|NCT01753323|Secondary|Time to Maximum Concentration (Tmax) - Part 1|Tmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. The 24h sampling of first post dose should be taken before the second dose. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Days 1 and 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.|||hour||Full Range|Median
2640611|NCT01753323|Secondary|Maximum Concentration (Cmax) - Part 1|Cmax was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. The 24h sampling of first post dose should be taken before the second dose. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Days 1 and 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.|||ng/mL||Standard Error|Mean
2640612|NCT01753323|Secondary|Area Under the Curve (AUC)0-24h - Part 1|AUC0-24h was analyzed using parent drug in plasma samples. On Day 1, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose. The 24h sampling of first post dose was taken before the second dose. On Day 3, samples were taken at pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96, 144, and 192 hours post dose.|Days 1 and 3|Pharmacokinetic (PK) analysis set for Cohorts 1 and 2: The PK set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation.|||(hr*ng/mL)||Standard Deviation|Mean
2640613|NCT01753323|Primary|28-day Cure Rate - Part 2|28-day cure rate was defined as the percentage of participants with blood parasite count of zero after 28 days of treatment.|Day 28|Intent-to-treat analysis set: the intent-to-treat analysis set included all randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
2640614|NCT01753323|Primary|Time to Parasite Clearance|Parasite clearance was determined by assessing the parasite count in blood, using thin film, thick film and blood density assessments.|Day 5|Pharmacodynamic (PD) analysis set for Cohorts 1, 2 and 3: The PD set included all participants who received at least one dose of study medication except for 1 participant from Cohort 1, who was excluded due to a protocol deviation, and 1 participant from Cohort 3, who was withdrawn on Day 1.|||Hours||95% Confidence Interval|Median
2640625|NCT01753193|Secondary|Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants|The SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms).|Baseline (Pre-dose on Day 1); and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 160, and 168|As-treated population included all participants who received any dose of study drug in the OLE study. Only participants who had ADA-positive assessments with reportable ADA titer results were analyzed for this outcome measure.|||Units on Score||Standard Deviation|Mean
2640615|NCT01753310|Secondary|Change From Baseline in CDIP-58 Total Score at Week 2.|The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening. The hierarchical testing procedure would only be conducted if the previous secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 4) reached a statistically significant treatment effect. This secondary efficacy endpoint (change from baseline in CDIP-58 total score at Week 2) was performed to characterise the full clinical effect.|2 weeks post-treatment|The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 8 subjects (6 from the Dysport® arm and 2 from the Placebo arm) had missing values for CDIP-58.|||units on a scale||Standard Deviation|Mean
2640616|NCT01753310|Secondary|Change From Baseline in Cervical Dystonia Impact Profile-58 (CDIP-58) Total Score at Week 4.|The CDIP-58 scale is a subject-based rating scale measuring the health impact of CD measured in 8 health dimensions including head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood and psychosocial functioning. Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas postive changes indicate worsening.|4 weeks post-treatment|The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 8 subjects (7 from the Dysport® arm and 1 from the Placebo arm) had missing values for CDIP-58.|||units on a scale||Standard Deviation|Mean
2640617|NCT01753310|Secondary|TWSTRS Responders at Week 4.|Treatment response was determined as the number of responders at Week 4 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 4 score - baseline score]/baseline score) * 100.|4 weeks post-treatment|The ITT population consisted of all randomised subjects.|||percentage of participants||95% Confidence Interval|Number
2640618|NCT01753310|Secondary|Change From Baseline in CGIC in CD at Week 4.|The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits.|4 weeks post-treatment|The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 3 subjects (all from the Dysport® arm) had missing values for CGIC.|||units on a scale||Standard Deviation|Mean
2640619|NCT01753310|Secondary|TWSTRS Responders at Week 2.|Treatment response was determined as the number of responders at Week 2 relative to the baseline TWSTRS total score. A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment. This was calculated as ([Week 2 score - baseline score]/baseline score) * 100.|2 weeks post-treatment|The ITT population consisted of all randomised subjects.|||percentage of participants||95% Confidence Interval|Number
2640620|NCT01753310|Secondary|Change From Baseline in Clinical Global Impression of Change (CGIC) in CD at Week 2.|The CGIC is an investigator-reported assessment of the global clinical change in CD since study treatment administration. The CGIC uses a seven-point Likert scale ranging from +3 (very much improved) to -3 (very much worse), and was assessed by the investigator at the Week 2 and Week 4 visits.|2 weeks post-treatment|The ITT population consisted of all randomised subjects. Only subjects with data available at the point of testing are reported. A total of 4 subjects (3 from the Dysport® arm and 1 from the Placebo arm) had missing values for CGIC.|||units on a scale||Standard Deviation|Mean
2640621|NCT01753310|Secondary|Change From Baseline in TWSTRS Total Score at Week 2.|The change from baseline in the TWSTRS total score at Week 2 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits.|2 weeks post-treatment|The ITT population consisted of all randomised subjects.|||units on a scale||Standard Deviation|Mean
2640622|NCT01753310|Primary|Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4.|The change from baseline in the TWSTRS total score at Week 4 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits.|4 weeks post-treatment|The modified ITT population consisted of all randomised subjects with both a baseline and a Week 4 post-treatment TWSTRS total score assessment.|||units on a scale||Standard Deviation|Mean
2640623|NCT01753193|Primary|Number of Participants With Adverse Events of Special Interest (AESIs)|An AESI is scientific and medical concern specific to understanding of the study drug. An AESI may be serious or non-serious. Number of participants with AESIs are reported.|From first dose of study drug (Day 1) through 168 weeks|As-treated population included all participants who received any dose of study drug in the OLE study.|||Participants|||Count of Participants
2640624|NCT01753193|Secondary|Number of ADA-positive Participants With TEAEs and TESAEs|The number of ADA-positive participants with TEAEs and TESAEs are reported.|Baseline (Pre-dose on Day 1) up to Week 168|As-treated population included all participants who received any dose of study drug in the OLE study. Only participants who had ADA-positive assessments with reportable ADA titer results were analyzed for this outcome measure.|||Participants|||Count of Participants
2641174|NCT01748071|Secondary|Mean Arterial Pressure|According to the measurement of mean arterial pressure before and after intravenous injection of opioid analgesics|10 minutes after the procedure||||mmHg||Standard Deviation|Mean
2640626|NCT01753193|Secondary|Number of ADA-positive Participants With Decreased Pharmacodynamics Response of Anifrolumab|Number of participants with decreased pharmacodynamic response of anifrolumab due to ADA-positive results are reported.|Baseline (Pre-dose on Day 1) up to Week 168|As-treated population included all participants who received any dose of study drug in the OLE study. Only participants who had ADA-positive assessments with reportable ADA titer results were analyzed for this outcome measure.|||Participants|||Count of Participants
2640627|NCT01753193|Secondary|Number of ADA-positive Participants With Decreased Serum Concentration of Anifrolumab|Number of participants with decreased serum concentration of anifrolumab due to ADA-positive results are reported.|Baseline (Pre-dose on Day 1) up to Week 168|As-treated population included all participants who received any dose of study drug in the OLE study. Only participants who had ADA-positive assessments with reportable ADA titer results were analyzed for this outcome measure.|||Participants|||Count of Participants
2640628|NCT01753193|Secondary|Anti-Drug Antibodies (ADA) Titer to Anifrolumab|Median ADA titer in participants with ADA-positive assessments and reportable ADA titer results are reported.|Baseline (Pre-dose on Day 1) up to Week 168|As-treated population included all participants who received any dose of study drug in the OLE study. Only participants who had ADA-positive assessments with reportable ADA titer results were analyzed for this outcome measure.|||Antibody titers||Full Range|Median
2640629|NCT01753193|Secondary|Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Anifrolumab|The number of participants with positive serum antibodies to anifrolumab at anytime (including baseline) are reported.|Baseline (Pre-dose on Day 1) up to Week 168|As-treated population included all participants who received any dose of study drug in the OLE study. Participants with reportable ADA titer results were analyzed for this outcome measure.|||Participants|||Count of Participants
2640630|NCT01753193|Primary|Number of Participants With Adverse Events Resulting in Discontinuation (DAEs) of Anifrolumab|Number of participants with DAEs are reported.|From first dose of study drug (Day 1) through 168 weeks|As-treated population included all participants who received any dose of study drug in the OLE study.|||Participants|||Count of Participants
2640631|NCT01753193|Primary|Number of Particpants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.|From first dose of study drug (Day 1) through 168 weeks|As-treated population included all participants who received any dose of study drug in the OLE study.|||Participants|||Count of Participants
2640632|NCT01753115|Secondary|Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) Levels|Blood was collected in arms 1 and 2 at day 48 ( 2 weeks following last vaccination) and in arm 3 at day 43 ( 2 weeks following last vaccination) for TNA assay to determine the NF50 antibody titer for calculating GMT.|Two weeks after last vaccination|BioThrax immunogenicity population: received 3 vaccinations and had samples taken within the study-specified windows; had a valid immunogenicity result within 2 wks of the last vaccination; had no evidence of previous anthrax vaccination and received the correct BioThrax dose at all 3 times; received vaccine maintained at the proper temperature.|||titer||95% Confidence Interval|Geometric Mean
2640633|NCT01753115|Primary|Ratios of Ciprofloxacin Area Under the Curve and Cmax (Day 5/Day 44)|Ratios of Area Under the Curve from zero to 12 hours (AUC0-12h) and maximum concentration (Cmax) achieved for ciprofloxacin (Day 5/Day 44).|Day 5 and Day 44 in Arm 1|Per protocol population: all subjects in arm 1 who received any dose of ciprofloxacin, had adequate PK data on Day 5 and Day 44, had received all three BioThrax doses, and who had no key protocol deviations (e.g., insufficient blood sample) that would be expected to affect the ciprofloxacin PK assessment.|||ratio||90% Confidence Interval|Mean
2640634|NCT01753076|Secondary|Change From Baseline in the Amyotrophic Lateral Sclerosis Assessment Questionnaire-40 (ALSAQ-40) Total Score at Week 48|The ALSAQ-40 is a disease specific health status assessment for individuals with ALS/motor neuron disease. The ALSAQ-40 is comprised of 40 questions measuring 5discrete dimensions of health status that are affected by the disease: physical mobility (10 items); activities of daily living and independence (10 items); eating and drinking (3 items); communication (7 items); emotional reactions (10 items). Participants were asked to indicate the frequency of each event by selecting one of five options (Likert scale: 0-4): never/rarely/sometimes/often/ always or cannot do at all. The total score (minimum possible score=0, maximum possible score=160) was calculated by adding the five domain scores. A low score indicates a better health state. Change from Baseline was calculated by subtracting the derived Baseline value from the post-Baseline value. A mixed-model repeated measures adjusted for treatment, Visit, Treatment by Visit, and Baseline ALSAQ-40 total score was used for the analysis.|Baseline and Week 48|ITT Population. Only participants with data available at the specified time points were analyzed|||Scores on a scale||Standard Error|Least Squares Mean
2640635|NCT01753076|Secondary|Change From Baseline in the EuroQol 5 Dimensions-5 Level Short Form (EQ-5D-5L) Utility Score at Week 48|A utility score for each participant was calculated based on the value set for England. The Week 0 (Visit 2) value was considered to be the Baseline value. Change from Baseline was calculated by subtracting the derived Baseline value from the post-Baseline value. EQ-5D-5L is a standardized, participant-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the EQ-Visual Analog Scale (EQ-VAS). The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). . For each of these dimensions, the participant self assigned a score: 1 (no problems); 2 (slight problems); 3 (moderate problems); 4 (severe problems); 5 (extreme problems).Minimum score on scale was 1 and maximum score was 5 for each dimension. A negative change from Baseline indicates improvement.|Baseline and Week 48|ITT Population. Only participants with data available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2641460|NCT01745913|Secondary|Transfusion Requirements After Haplo-identical Umbilical Cord Blood Transplant Versus Double Umbilical Cord Blood Transplant||estimation of 24 months to determine transfusion requirements of all subjects|||||||
2640636|NCT01753076|Secondary|Progression-free Survival at Week 48|Progression-free survival at Week 48 is defined as the time from randomization to progression (decline of at least six points on the ALSFRS-R from Baseline) or death or censored at Week 48, whichever comes first. Kaplan Meier estimates at Week 48 were evaluated at Day 344. A participant was considered to have completed if he/she was censored at Day 344. Confidence intervals were estimated using the Brookmeyer Crowley method. Results are shown as the estimated percentage of participants alive and without disease progression at Week 48.|Week 48|ITT Population. Only on-treatment data (data within 21 days of the last dose) were analyzed.|||Percentage of participants surviving||95% Confidence Interval|Number
2640637|NCT01753076|Secondary|Overall Survival at Week 48 and Week 60|Overall survival is defined as the time from randomization to death or censoring at the time point of analysis, whichever comes first. Kaplan Meier estimates at Week 48 were evaluated at Day 344. A participant was considered to have completed if he/she was censored at Day 344. Kaplan Meier estimates at Week 60 were evaluated at Day 428. A participant was considered to have completed if he/she was censored at Day 428. Confidence intervals were estimated using the Brookmeyer Crowley method. Results are shown as the estimated percentage of participants alive at Weeks 48 and 60. Week 48: Only on-treatment data (data within 21 days of the last dose) were analyzed. Week 60: Including off treatment data (data after 21 days after the last dose) were analyzed.|Week 48 and Week 60|ITT Population|||Percentage of participants||95% Confidence Interval|Number
2640638|NCT01753076|Secondary|Number of Clinical Global Impression-improvement Scale (CGI-I) Responders at Week 48|The CGI-I scale is a single observer-rated item measuring global improvement relative to Baseline. The CGI-I score is rated on a 7-point scale, from 1 (very much improved) to 7 (very much worse). Participant status at Baseline was assessed using the Clinical Global Impression Severity scale (CGI-S), which is a 7-point scale (1: normal, not at all ill; 7: most extremely ill) used to rate the severity of the participant's illness. Participants achieving a score of 1-4 in the CGI-I at Week 48 were considered to be responders. A a logistic regression adjusted for CGI-S at Baseline, riluzole use, and world region was used for the analysis.|Week 48|ITT Population. Only participants with data available at the specified time points were analyzed.|||Participants|||Number
2640639|NCT01753076|Secondary|Change From Baseline in Muscle Strength as Measured by Hand Held Dynamometry (HHD) Score at Week 48|The HHD is a device placed between the hand of the practitioner and the tested body part and provides a quantified measurement of muscle strength. Each muscle was tested twice, and both values were recorded. Additionally, a third trial could have been performed if the variability between the first two trials was greater than 15 % or if the rater thought that one of the first two trials was not valid. The Week 0 (Visit 2) value was considered to be the Baseline value. Percent change from Baseline for each muscle group was calculated as 100*(HHD score minus the Baseline score) divided by the Baseline score. The average percent change was the mean percent change across the muscle groups that were non-missing/non-zero at Baseline. MMRM adjusted for treatment, visit, treatment by visit, number of non-missing/non-zero muscle groups at Baseline, number of non-missing/non-zero muscle groups at Baseline by Visit, riluzole use, and country group was used for the analysis.|Baseline and Week 48|ITT Population. Only participants with data available at the specified time points were analyzed.|||Percent change||Standard Error|Least Squares Mean
2640640|NCT01753076|Secondary|Change From Baseline in Slow Vital Capacity (SVC) at Week 48|SVC was measured by using a validated spirometer. Three SVC measurements were performed for each participant at each assessment provided the difference from the second trial (if arranged by the numerical value) was not greater than 10%. If the difference between the best and the next best (based on the largest numerical value) SVC value from the first three trials was greater than 10%, additional trials (up to 5 in total) could have been performed. The Week 0 (visit 2) value was considered to be the Baseline value. Change from Baseline was calculated by subtracting the derived Baseline value from the post-Baseline value. A mixed-model repeated measures (MMRM) adjusted for treatment, visit, treatment by visit, Baseline SVC, Baseline SVC by visit, riluzole use. and country group was used for the analysis.|Baseline and Week 48|ITT population. Only those participants available at indicated time points were analyzed.|||Liters (L)||Standard Error|Least Squares Mean
2640641|NCT01753076|Secondary|Rate of Decline Over Week 48 in the ALSFRS-R Total Score|The rate of decline was estimated by the change from Baseline in ALSFRS-R. The monthly slope for the ALSFRS-R score (i.e., the monthly rate of decline) was calculated as change from Baseline in the ALSFRS-R score at the last visit for that treatment period divided by the study day at the last visit for that treatment period devided by 30.4. The Week 0 (Visit 2) value was considered to be the Baseline value. Change from Baseline was calculated by subtracting the derived Baseline value from the post-Baseline value. The ALSFRS-R was a quickly administered (5 min) ordinal rating scale used to determine a participant's assessment of their capability and independence in 12 functional activities. There were 12 questions, graded by the participant 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.|Baseline to Week 48|ITT Population. Only on-treatment data (data within 21 days of the last dose) were analyzed..|||change in scores on a scale per month||Standard Error|Least Squares Mean
2640642|NCT01753076|Secondary|Change From Baseline in the ALSFRS-R Total Score at Week 48|The rate of decline was estimated by the change from Baseline in ALSFRS-R. The monthly slope for the ALSFRS-R score (i.e., the monthly rate of decline) was calculated as change from Baseline in the ALSFRS-R score at the last visit for that treatment period divided by the study day at the last visit for that treatment period /30.4. The Week 0 (Visit 2) value was considered to be the Baseline value. Change from Baseline was calculated by subtracting the derived Baseline value from the post-Baseline value. The ALSFRS-R was a quickly administered (5 min) ordinal rating scale used to determine a participant's assessment of their capability and independence in 12 functional activities. There were 12 questions, graded by the participant 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.|Baseline and Week 48|ITT Population. Only on-treatment data (data within 21 days of the last dose) were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2640652|NCT01752933|Secondary|Progression-free Survival|Progression-free survival measured in days. Progression-free survival was defined as the time interval from the date of the first dose of study treatment to the earlier of 1) documented radiologic progression per RECIST v1.1 or clinical progression, or 2) death due to any cause.|Through completion of response assessments (i.e., until disease progression or treatment discontinuation), an average of 112 days.|Includes all patients who received any guadecitabine|||days||95% Confidence Interval|Median
2640643|NCT01753076|Primary|Joint Rank Scores for Combined Analysis of Function (Amyotrophic Lateral Sclerosis Functional Rating Scale Revised [ALSFRS-R] Score) and 48 Week Overall Survival|The joint rank score is a combined assessment of function and survival. Function is assessed using change from Baseline in the ALSFRS-R total score. To calculate joint rank scores, every participant was compared with all other participants in a pair wise manner and assigned a score of -1, 0 or 1 based on their relative outcomes. A subject's joint rank score is the sum of their scores across the pair wise comparisons. The . The ALSFRS-R was a quickly administered (5 min) ordinal rating scale used to determine a participant's assessment of their capability and independence in 12 functional activities. There were 12 questions, graded by the participant 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing. Lower scores of ALSFRS-R reflect greater impairment.|Week 48|ITT population. Only on-treatment data (data within 21 days of the last dose) were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2640644|NCT01752985|Secondary|Dose-Response Relationship Using Change in Baseline Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment|The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples. UACR was calculated as the geometric mean of two first-morning void urine UACR measurements with samples collected on two separate occasions within a 4-day period. The effect of BMS-813160 on urinary albumin excretion as measured by UACR values in participants with diabetic kidney disease after 12 weeks of treatment was assessed. The model included treatment group as a main effect, and the log of baseline UACR values, as well as baseline values of eGFR, blood pressure, blood glucose and lipid levels, as covariates.|Baseline, Weeks 2, 4, 8 and 12|Data was not collected for any participants due to termination of the study||||||
2640645|NCT01752985|Secondary|Renal Clearance (CLr) of BMS-813160|CLr was calculated by dividing the total amount excreted in the urine from 0 to 6 hours by the area under the plasma concentration-time curve from time zero extrapolated to infinite time. The renal function was classified based on estimated glomerular filtration rate as normal (>=90 mL/min/1.73 m^2), mildly impaired (60-89 mL/min/1.73 m^2), moderately impaired stage 3A (45-59 mL/min/1.73 m^2), and moderately impaired stage 3B (30-44 L/min/1.73 m^2).|Pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose at Week 12|The analysis was planned to be performed in the Pharmacokinetic (PK) analysis set which included all participants who receive a dose of study drug and have adequate PK concentration-time data.Data was not collected for any participants due to termination of the study||||||
2640646|NCT01752985|Secondary|Area Under The Plasma Concentration-Time Curve From Time Zero to 6 Hours Post-Dose [AUC(0-6 h)]|AUC(0-6 h) is the area under the plasma concentration-time curve from pre-dose (0 h) to 6 h post-dose.|Pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose at Week 12|The analysis was planned to be performed in the Pharmacokinetic (PK) analysis set which included all participants who receive a dose of study drug and have adequate PK concentration-time data. Data was not collected for any participants due to termination of the study||||||
2640647|NCT01752985|Secondary|Trough Observed Plasma Concentration (Ctrough) of BMS-813160|Ctrough is the minimum estimated plasma concentration at steady state.|Pre-dose at Week 2, 4, 8, 12 and 0.5, 1, 2, 4, and 6 hours post-dose at Week 12|The analysis was planned to be performed in the Pharmacokinetic (PK) analysis set which included all participants who receive a dose of study drug and have adequate PK concentration-time data. Data was not collected for any participants due to termination of the study||||||
2640648|NCT01752985|Secondary|Number of Participants With Out-of-Range Electrocardiogram (ECG) Interval|12-lead ECGs were performed before and 1 hour after dosing at Weeks 0, 2 and 4. ECGs were recorded after the participant has been supine for at least 5 minutes. The PR interval was defined as the beginning of the P wave to the beginning of the QRS complex, and represents the time taken by electrical impulse to travel from the sinus node through the atrioventricular (AV) node. The QRS complex represented the rapid depolarization of the right and left ventricles. The QT interval was defined as the time from the start of the Q wave to the end of the T wave, and represents the time taken for ventricular depolarization and repolarization. Participants were evaluated for abnormal ECG intervals. Criteria's for abnormality were PR >200, QRS >120, QT >500, QTcF >450, Change From Baseline >30 milliseconds (msec).|Baseline up to Week 16|The analysis was performed in all the participants who received any study drug.|||Participants|||Count of Participants
2640649|NCT01752985|Secondary|Number of Participants With Serious Adverse Events (SAEs), Who Died and With Other (Not Including Serious) Adverse Events|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event.|From the date of subject's written consent until 30 days post discontinuation of dosing, assessed up to 26 months|The analysis was performed in all the participants who received any study drug.|||Participants|||Count of Participants
2640650|NCT01752985|Primary|Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment With BMS-813160|The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples. UACR was calculated as the geometric mean of two first-morning void urine UACR measurements with samples collected on two separate occasions within a 4-day period.|Baseline, Weeks 2, 4, 8, 12, and 16 (Follow-up)|The analysis was performed in all the participants who received any study drug. Here, 'n' signifies evaluable participants for specified categories in respective treatment arms.|||Percent Change||Standard Deviation|Mean
2640651|NCT01752933|Secondary|Overall Survival|Overall survival measured in days.|Through completion of study survival follow-up, an average of 270 days.|Includes all patients who received any guadecitabine|||days||95% Confidence Interval|Median
2640653|NCT01752933|Secondary|Duration of Response|Duration of response as measured in days. Included subjects with a complete response or partial response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.|From time of first response until disease progression or date of death due to any cause, whichever occurred earlier; an average of 192 days.|Assessed for patients who had a clinical response|||days||95% Confidence Interval|Median
2640654|NCT01752933|Secondary|Alpha Fetoprotein Response as a Result of Guadecitabine Administration|Percentage of patients with best post baseline alpha fetoprotein reduction of 50% or more|Varied by patient (median number of treatment cycles was 2.0 (range 2-8) in 60 mg/m^2 group, and 4.0 (range 1-13) in 45 mg/m^2 group|Includes all patients who received any guadecitabine|||Participants|||Count of Participants
2640655|NCT01752933|Secondary|Safety and Tolerability of Guadecitabine|Number of patients with serious adverse events and adverse events|Varied by patient (median number of treatment cycles was 2.0 (range 2-8) in 60 mg/m^2 group, and 4.0 (range 1-13) in 45 mg/m^2 group|Includes all patients who received any guadecitabine|||Participants|||Count of Participants
2640656|NCT01752933|Primary|Disease Control Rate (DCR) at 16 Weeks for Patients Treated With Guadecitabine After Failure of Sorafenib|Percentage of patients achieving a best overall response of complete response (CR) or partial response (PR) plus subjects with stable disease at 16 weeks after the start of treatment. Response was assessed based on the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for target and non-target lesions using computed tomography (CT) or magnetic resonance imaging (MRI) as follows: Complete Response (CR), disappearance of all target lesions, disappearance of all non-target lesions, and normalization of tumor marker level; Partial Response (PR), at least a 30% decrease in the sum of diameters of target lesions from baseline; Progressive Disease (PD), at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions, and unequivocal progression of non-target lesions; Stable Disease, neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for PD (Eisenhauer et al. 2009, Eur. J. Cancer 45:228-247).|16 weeks|Patients who met major inclusion/exclusion criteria and followed the study protocol without a significant deviation (1 patient excluded because did not have confirmed HCC; 4 patients excluded because did not have a Week 16 assessment).|||percentage of patients||95% Confidence Interval|Number
2640657|NCT01752907|Secondary|Percentage of Participants Who Used Analgesics for the Treatment of Bone Pain by Cycle and Across Cycles|Analgesic use includes both analgesic and non-steroidal anti-inflammatory drugs.|From Day 1 of Cycle 2 until 30 days after the last dose of pegfilgrastim, up to approximately 16 weeks.|Full analysis set|||percentage of participants|||Number
2640658|NCT01752907|Secondary|Percentage of Participants With Grade 3 or 4 Bone Pain Captured in Standard Adverse Event Reporting|"Participants with grade 3 or 4 bone pain as captured during standard adverse event reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis. The severity of each AE was graded using the Common Terminology criteria for Adverse Events (CTCAE) version 3 and are based on the following:~Grade 1 = Mild AE; Grade 2 = Moderate AE; Grade 3 = Severe AE; Grade 4 = Life-threatening or disabling AE; Grade 5 = Death related to AE."|From randomization until 30 days after the last dose of pegfilgrastim, up to approximatley 20 weeks.|Full analysis set|||percentage of participants|||Number
2640659|NCT01752907|Secondary|Percentage of Participants With Any Grade Bone Pain as Captured in Standard Adverse Event Reporting|Participants with any grade of bone pain as captured during standard adverse event (AE) reporting. A pre-defined list of Medical Dictionary for Regulatory Activities (MedDRA) version 17.1 preferred terms was used to determine if a participant experienced bone pain: Arthralgia, Arthritis, Back pain, Bone pain, Chest discomfort, Groin discomfort, Limb discomfort, Musculoskeletal chest pain, Musculoskeletal discomfort, Musculoskeletal pain, Neck pain, Non-cardiac chest pain, Osteochondritis Pain, Pain in extremity, Pain in jaw, Pelvic pain, Pubic pain, Sacroiliitis, Spinal pain, Spondylitis.|From randomization until 30 days after the last dose of pegfilgrastim, up to approximately 20 weeks|Full analysis set|||percentage of participants|||Number
2640660|NCT01752907|Secondary|Patient-reported Bone Pain Area Under the Curve (AUC) by Cycle and Across All Cycles|Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from Day 1-5 for each cycle. AUC may range from 0 to 40 per cycle.|Days 1-5 for 4 treatment cycles|Full analysis set with imputation|||units on a scale * days||Standard Error|Mean
2640661|NCT01752907|Secondary|Mean Patient-reported Bone Pain by Cycle and Across All Cycles|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.|Days 1-5 for 4 treatment cycles|Full analysis set with imputation|||units on a scale||Standard Error|Mean
2640662|NCT01752907|Secondary|Maximum Patient-reported Bone Pain by Cycle and Across All Cycles|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.|Days 1-5 for each treatment cycle|Full analysis set with imputation|||units on a scale||Standard Deviation|Mean
2640663|NCT01752907|Primary|Maximum Patient-reported Bone Pain in Cycle 1|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 to 10 scale, where 0 = no pain and 10 indicates worst pain.|Days 1 to 5 during cycle 1.|Full analysis set with imputation|||units on a scale||Standard Error|Mean
2640664|NCT01752855|Secondary|Percentage of Participants Positive for Anti-adalimumab Antibody|Percentage of participants with anti-adalimumab antibody|Week 24 through Week 48|All participants who received at least one dose of study drug.|||percentage of participants|||Number
2640676|NCT01752712|Secondary|Defeatist Performance Attitudes Scale (DPAS) Total Score|"Determine if CBSST + oxytocin compared to CBSST + placebo is associated with defeatist performance beliefs. The total DPAS score is calculated by adding the scores for scales #1-#18. Each scale ranges from 1=Agree Totally to 7=Disagree Totally. Total scores range from a minimum score of 18 to a maximum score of 126. Reverse scoring was applied to make higher scores indicate a stronger defeatist attitude."|Treatment weeks 0, 12, and 24, plus follow-up week 36|Only participants who were enrolled in the study and had completed a DPAS assessment were analyzed at each study time point.|||units on a scale||Standard Deviation|Mean
2641461|NCT01745913|Secondary|Platelet Recovery After Transplant Regimens|No patients completed this study and are therefore inevaluable|estimation of 24 months to determine platelet recovery for all subjects|Data not collected. Patients died.||||||
2640665|NCT01752855|Primary|Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.|Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48|Data from participants receiving the new formulation of adalimumab in Study NCT01712178 were analyzed for 44 and 43 participants, respectively, at weeks 36 and 48. Data for the participants receiving the current formulation of adalimumab in Study NCT01712178 were analyzed for 43 participants at week 36 and 40 participants at week 48.|||units on a scale||Standard Deviation|Mean
2640666|NCT01752855|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48|"American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment~CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))"|Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48|All participants who received at least one dose of study drug.|||percentage of participants|||Number
2640667|NCT01752855|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48|"American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment~CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))"|Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48|All participants who received at least one dose of study drug.|||percentage of participants|||Number
2640668|NCT01752855|Primary|Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48|The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48|All available data were included. If a participant did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.|||units on a scale||Standard Deviation|Mean
2640669|NCT01752842|Secondary|Change in C24:0/C16:0 Ceramide Ratio|Mass spectrometry-based quantification of the ratio of C24:0 ceramide to C16:0 ceramide in plasma.|Baseline and 12 weeks|All participants for whom C24:0 and C16:0 ceramides were measured at baseline and 12 weeks.|||ratio||Standard Deviation|Mean
2640670|NCT01752842|Primary|Change in Cardiac Systolic Function as Measured by Fractional Shortening Percent|Change was measured by echocardiography and was calculated as the value at 12 weeks minus the value at baseline.|Baseline and 12 weeks|All participants for whom fractional shortening was measured at baseline and 12 weeks.|||percent||Standard Deviation|Mean
2640671|NCT01752842|Primary|Change in Cardiac Diastolic Function as Measured by E' (cm/s)|Change was measured by echocardiography and was calculated as the value at 12 weeks minus the value at baseline.|Baseline and 12 weeks|All participants for whom E' (diastolic function) was measured at baseline and 12 weeks.|||cm/s||Standard Deviation|Mean
2640672|NCT01752712|Secondary|Brief Psychiatric Rating Scale (BPRS) Psychosis Score|"The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating."|Every 4 weeks during the treatment phase, plus follow-up week 36|Only participants who were enrolled in the study and had completed a BPRS assessment were analyzed at each study time point.|||units on a scale||Standard Deviation|Mean
2640673|NCT01752712|Secondary|Brief Psychiatric Rating Scale (BPRS) Total Score|"The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from 1=Not Present to 7=Very Severe. Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating."|Every 4 weeks during the treatment phase, plus follow-up week 36|Only participants who were enrolled in the study and had completed a BPRS assessment were analyzed at each study time point.|||units on a scale||Standard Deviation|Mean
2640674|NCT01752712|Secondary|Schedule for Assessment of Negative Symptoms (SANS) Total Score|SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.|Every 4 weeks during the treatment phase, plus follow-up week 36|Only participants who were enrolled in the study and had completed a SANS assessment were analyzed at each study time point.|||units on a scale||Standard Deviation|Mean
2640675|NCT01752712|Secondary|Asocial Belief Scale (ABS) Total Score|Determine if CBSST + oxytocin compared to CBSST + placebo is associated with asocial beliefs. The total ABS score is calculated by adding the scores for items #1-#15. Each scale is provided a True/False response, with True responses equaling 1 point and False responses equaling 0 points. In calculating the ABS total score, four of the 15 items of the ABS were reverse scored. A lower total score indicates more severe asocial beliefs.|Treatment weeks 0, 12, and 24, plus follow-up week 36|Only participants who were enrolled in the study and had completed a ABS assessment were analyzed at each study time point.|||units on a scale||Standard Deviation|Mean
2640694|NCT01751971|Secondary|Subjective Sleepiness/Alertness (Stanford Sleepiness Scale)|Assessed in the morning after the single night of treatment. Minimum score: 1 (alert), maximum score: 7 (not alert).|1 night|Patients with AHI>20|||Scores on a scale||Standard Error|Mean
2640677|NCT01752712|Primary|Birchwood Social Function Scale (BSFS) Total Score|"Determine if CBSST + oxytocin compared to CBSST + placebo is associated with improved social function. There are 7 individual sections, with each section asking about different aspects of social functioning. Scores for Section 1: Social Engagement Withdrawal range from 0-15; Section 2: Interpersonal Communication/Relationships ranges from 0-30; Section 3: Prosocial Activities range is 0-66; Section 4: Recreation ranges from 0-48; Section 5: Independence (Performance) ranges from 0-39; Section 6: Independence (Competence) ranges from 0-39; and Section 7: Occupation/Employment ranges from 0-6 if the participant is unemployed or 7-10 if the participant is employed. The minimum value possible is 0 for participants who are unemployed and 7 for those with employment. The total BSFS score is calculated by adding the total scores from each of the 7 sections, with a maximum total score of 247. A lower total score indicates a lower social function rating."|Treatment weeks 0, 12, and 24, plus follow-up week 36|Only participants who were enrolled in the study and had completed a BSFS assessment were analyzed at each study time point.|||units on a scale||Standard Deviation|Mean
2640678|NCT01752426|Secondary|Percentage of Recently Born Leukemia Cells Mobilized Into the Blood by PCI-32765 Treatment|Measurement of the fraction of recently born versus older leukemia cells in the peripheral blood of participants before and during PCI-32765 therapy, to determine the effects of PCI-32765 (ibrutinib) therapy on the birth rates of the leukemia cells.|every three months, up to one year||||percentage of leukemia cells||Full Range|Median
2640679|NCT01752426|Primary|Change in Leukemia Cell Death|Stable isotopic labeling with deuterated water (2^H2O) to measure directly the effects of PCI-32765 (ibrutinib) on leukemia cell death in the peripheral blood of participants .|every three months, up to one year||||percentage of cell death||Full Range|Median
2640680|NCT01752400|Secondary|Median Overall Survival|The median duration of time from the start of treatment until the time of death or until the participant withdraws participation in the trial.|From the start of treatment until death or withdrawal from the study||||Months||95% Confidence Interval|Median
2640681|NCT01752400|Secondary|ALK Mutation Status|The number of secondary ALK mutations or ALK amplification as a mechanism of resistance in pre-treatment and post-treatment biopsies.|Baseline, end of treatment|Data not available for the other 5 participants|||Participants|||Count of Participants
2640682|NCT01752400|Secondary|ALK Translocation Variant Type||Baseline|Data unavailable for all six participants||||||
2640683|NCT01752400|Secondary|Number of Participants With Concurrent KRAS Mutations||Baseline||||Participants|||Count of Participants
2640684|NCT01752400|Secondary|Number of Participants Who Develop Adverse Events on AUY922|The number of participants that developed any grade adverse event as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)|From the start of treatment until 30 days after last dose was received||||Participants|||Count of Participants
2640685|NCT01752400|Secondary|Disease Control Rate|"The number of participants that achieved disease control, which includes complete responses, partial responses or stable disease as assessed by RECIST v1.1~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|Baseline and then every six weeks (± 7 days), until the time of disease progression||||Participants|||Count of Participants
2640686|NCT01752400|Secondary|Progression-free Survival|"Progression free survival is measured as the number of months from date of study entry to date of progression or death, whichever comes first. Progression is assessed using RECIST v1.1.~Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study with at least a 5 mm absolute increase in the sum of all lesions. The appearance of one or more new lesions denotes disease progression."|From the start of treatment until the time of death or progression||||Months||95% Confidence Interval|Median
2640687|NCT01752400|Primary|Objective Response Rate|"The number of participants that achieved either a complete response (CR) or a partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST v1.1).~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph node must have reduction in short axis to < 10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|Baseline and then every six weeks (± 7 days), until the time of disease progression||||Participants|||Count of Participants
2640688|NCT01752023|Secondary|Tumor Necrosis|To assess changes in tumor necrosis in response to cisplatin and gemcitabine with or without SUBATM-itraconazole.|2 years.|Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.||||||
2640689|NCT01752023|Secondary|Itraconazole Exposure Parameters|To correlate itraconazole exposure parameters with median time to progression and median survival in this patient population.|2 years.|Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.||||||
2640690|NCT01752023|Secondary|Adverse Effects|To characterize the adverse effects of cisplatin and gemcitabine with or without SUBATM-itraconazole in this patient population.|2 years.|Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.||||||
2640691|NCT01752023|Secondary|Median Time to Progression|To determine the median time to progression and median duration of survival of patients with metastatic squamous non-small cell lung cancer treated with cisplatin and gemcitabine with or without SUBATM-itraconazole.|2 years.|Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.||||||
2640692|NCT01752023|Primary|Tumor Blood Flow.|To assess the changes in tumor blood flow as measured by contrast enhanced MRI scanning in patients with metastatic squamous non-small cell lung cancer treated with cisplatin and gemcitabine with or without SUBATM-itraconazole.|6 weeks.|Study closed due to early stopping rule. There were only 3 patients enrolled which were therefore not analyzed.||||||
2640693|NCT01752023|Primary|Objective Response Rates|Per response evaluation criteria in solid tumors criteria|6 weeks|Trial closed due to early stopping rule, patients were not analyzed as there were only 3 patients enrolled.||||||
2641481|NCT01745380|Secondary|Number of Participants With a Heart Rate Higher Than 125 Bpm||at any time within 120 minutes following drug administration||||participants|||Number
2640695|NCT01751971|Secondary|Subjective Sleep Quality (Oxygen vs Sham)|"Better(+1)/Same(0)/Worse(-1) on oxygen vs sham, i.e. a relative comparison between arms. When subjects had completed the entire study, they were asked to compare subjectively their sleep quality on the first versus second study."|1 night|Patients with AHI>20. One patient, whose treatment and sham nights were separated by an extended duration (due to scheduling), did not provide data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2640696|NCT01751971|Secondary|Overnight Change in Diastolic Blood Pressure|The change in diastolic blood pressure overnight. Two supine oscillometric measurements of blood pressure are made: just prior to lights out (evening), and after lights on (morning).|1 night|Patients with AHI>20|||mmHg||Standard Error|Mean
2640697|NCT01751971|Secondary|Overnight Change in Systolic Blood Pressure|The change in systolic blood pressure overnight. Two supine oscillometric measurements of blood pressure are made: just prior to lights out (evening), and after lights on (morning).|1 night|Patients with AHI>20|||mmHg||Standard Error|Mean
2640698|NCT01751971|Secondary|Frequency of EEG Arousals (Events Per Hour)|Frequency of scored EEG arousals per hour of non-REM sleep. Note: Our objective was to describe changes in secondary outcomes within phenotypic subgroups. Overall effects (unselected patients / ignoring phenotypic subgroups) are first presented below, followed by effects in favorable vs. unfavorable subgroups.|1 night|Patients with AHI>20|||events/hr||Standard Error|Mean
2640699|NCT01751971|Primary|Apnea-hypopnea Index|"Apnea-hypopnea index (AHI) will be compared between oxygen and sham nights. Hypopneas are based on 30% reduction in airflow (no desaturation or arousal criteria). AHI data are exclusive to non-REM supine sleep.~The results presented here are for the AHI at each intervention (per intervention) regardless of the sequence (preferred clinicaltrials.gov format).~Please note, however, that the a priori outcome measure was the reduction in AHI with oxygen as a percent of sham values, i.e. (AHI on sham - AHI on oxygen)/(AHI on sham) % (a comparison with greater statistical power), compared between patient subgroups (see Statistical Analysis section).~Subgroups were defined a priori as higher (>=0.7) versus lower loop gain (<0.7), but tests were also performed in subgroups defined by favorable versus unfavorable pathophysiology."|1 night|Patients with AHI>20|||events/hour||Standard Error|Mean
2640700|NCT01751906|Other Pre-specified|Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)||3-10 years||2025-12-31|12/2025||||
2640701|NCT01751906|Other Pre-specified|Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)||3-9 years||2024-12-31|12/2024||||
2640702|NCT01751906|Other Pre-specified|Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)||3-8 years||2023-12-31|12/2023||||
2640703|NCT01751906|Other Pre-specified|Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)||3-7 years||2022-12-31|12/2022||||
2640704|NCT01751906|Other Pre-specified|Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)||3-6 years||2021-12-31|12/2021||||
2640705|NCT01751906|Other Pre-specified|Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)||3-5 years||2020-12-31|12/2020||||
2640706|NCT01751906|Other Pre-specified|Landmark Analysis on Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)||3-4 years||2019-12-31|12/2019||||
2640707|NCT01751906|Other Pre-specified|Landmark Analysis on TLF and Components||3-10 years||2025-12-31|12/2025||||
2640708|NCT01751906|Other Pre-specified|Landmark Analysis on TLF and Components||3-9 years||2024-12-31|12/2024||||
2640709|NCT01751906|Other Pre-specified|Landmark Analysis on TLF and Components||3-8 years||2023-12-31|12/2023||||
2640710|NCT01751906|Other Pre-specified|Landmark Analysis on TLF and Components||3-7 years||2022-12-31|12/2022||||
2640711|NCT01751906|Other Pre-specified|Landmark Analysis on TLF and Components||3-6 years||2021-12-31|12/2021||||
2640712|NCT01751906|Other Pre-specified|Landmark Analysis on TLF and Components||3-5 years||2020-12-31|12/2020||||
2640713|NCT01751906|Other Pre-specified|Landmark Analysis on TLF and Components||3-4 years||2019-12-31|12/2019||||
2640714|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Dyspnea Severity|"Dyspnea severity assessed using the Rose Dyspnea Scale (RDS).~Rose Dyspnea Scale:~Scale range: 0 to 4~Lower values represent better outcomes (higher scores indicate worse dyspnea)~No subscales"|12 months|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
2640715|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Dyspnea Severity|"Dyspnea severity assessed using the Rose Dyspnea Scale (RDS).~Rose Dyspnea Scale:~Scale range: 0 to 4~Lower values represent better outcomes (higher scores indicate worse dyspnea)~No subscales"|1 month|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
2640716|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Dyspnea Severity|"Dyspnea severity assessed using the Rose Dyspnea Scale (RDS).~Rose Dyspnea Scale:~Scale range: 0 to 4~Lower values represent better outcomes (higher scores indicate worse dyspnea)~No subscales"|Baseline|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
2640717|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Disease-Specific Quality of Life|"Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ).~Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life)."|12 months|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
2640753|NCT01751906|Secondary|Number of Participants Experienced Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|0 to 30 days|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2657973|NCT01601977|Secondary|Total Sleep Time|Full polysomnography performed at baseline (usual device) and 6 weeks (trial device) to examine TST|baseline, 6 weeks||||minutes||Standard Deviation|Mean
2640718|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Disease-Specific Quality of Life|"Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ).~Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life)."|1 month|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
2640719|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Disease-Specific Quality of Life|"Disease-Specific quality of life assessed using the Seattle Angina Questionnaire (SAQ)~Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life)."|Baseline|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
2640720|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Anxiety|"Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7).~GAD-7:~Scale range: 0 to 21~Lower values represent better outcomes~No subscales"|12 months|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
2640721|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Anxiety|"Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7).~GAD-7:~Scale range: 0 to 21~Lower values represent better outcomes~No subscales"|1 month|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
2640722|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Anxiety|"Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7).~GAD-7:~Scale range: 0 to 21~Lower values represent better outcomes~No subscales"|Baseline|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
2640723|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Overall Health Status|"Overall health status assessed using the EuroQoL 5D (EQ-5D™).~EQ-5D:~Scale range: 0 to 1~Higher values represent better outcomes~Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status.~A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1"|12 months|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
2640724|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Overall Health Status|"Overall health status assessed using the EuroQoL 5D (EQ-5D™).~EQ-5D:~Scale range: 0 to 1~Higher values represent better outcomes~Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status.~A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1"|1 month|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
2640725|NCT01751906|Other Pre-specified|Patient Reported Outcomes (PRO): Overall Health Status|"Overall health status assessed using the EuroQoL 5D (EQ-5D™).~EQ-5D:~Scale range: 0 to 1~Higher values represent better outcomes~Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status.~A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1"|Baseline|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||score on a scale||Standard Deviation|Mean
2640726|NCT01751906|Secondary|Optical Coherence Tomography (OCT) Endpoint|"All OCT endpoints will be collected for within the device and within the treated segment:~Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions"|3 years||2019-12-31|12/2019||||
2640727|NCT01751906|Secondary|Powered Imaging Cohort Secondary Endpoint: The In-stent/Scaffold Mean Lumen Area Change, From Post-procedure to 3 Years by Intravascular Ultrasound (IVUS)|"Mean lumen area measured after nitrate infusions, superiority test, ~300 pooled subjects.~Pooled IVUS subjects (~300 subjects): 150 subjects from the Imaging Cohort of ABSORB III RCT and 150 subjects from ABSORB Japan RCT."|3 years||2019-12-31|12/2019||||
2640728|NCT01751906|Secondary|Powered Imaging Cohort Secondary Endpoint: The In-stent/Scaffold Mean Lumen Diameter Change, Between Pre- and Post-nitrate Infusion at 3 Years by Angiography|Pooled angiographic subjects (~600 subjects): 200 subjects from the Imaging Cohort of ABSORB III and 400 subjects from the ABSORB Japan RCT.|3 years||2019-12-31|12/2019||||
2640729|NCT01751906|Secondary|Post-Procedure In-Device Percent Diameter Stenosis (%DS)|Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|≤ 7 days post index procedure|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||Percent Diameter stenosis|Target Lesions|Standard Deviation|Mean
2640730|NCT01751906|Secondary|Post-Procedure In-Segment Percent Diameter Stenosis (%DS)|"Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).~In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold."|≤ 7 days post index procedure|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||Percent Diameter stenosis|Target Lesions|Standard Deviation|Mean
2640731|NCT01751906|Secondary|Post-Procedure In-Device Minimum Lumen Diameter (MLD)|"Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.~In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold"|≤ 7 days post index procedure|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||Millimeter|Target Lesions|Standard Deviation|Mean
2640732|NCT01751906|Secondary|Post-Procedure In-Segment Minimum Lumen Diameter (MLD)|"Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.~In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold."|≤ 7 days post index procedure|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||Millimeter|Target Lesions|Standard Deviation|Mean
2640733|NCT01751906|Secondary|Pre-Procedure Percent Diameter Stenosis (%DS)|Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|< or = 1 day|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||Percent Diameter stenosis|Target Lesions|Standard Deviation|Mean
2640734|NCT01751906|Secondary|Pre-Procedure Minimum Lumen Diameter (MLD)|Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.|< or = 1 day|ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.|||Millimeter|Target Lesions|Standard Deviation|Mean
2640735|NCT01751906|Secondary|Number of Participants With Cumulative Stent/Scaffold Thrombosis|"Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing :~Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.~Evidence:~Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.~Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of~Any unexplained death within the first 30 days or~Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|0 to 1123 Days|Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640736|NCT01751906|Secondary|Number of Participants With Cumulative Stent/Scaffold Thrombosis|"Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing :~Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.~Evidence:~Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.~Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of~Any unexplained death within the first 30 days or~Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|0 to 758 Days|Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640737|NCT01751906|Secondary|Number of Participants With Cumulative Stent/Scaffold Thrombosis (Per ARC Definition)|"Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing :~Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.~Evidence:~Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.~Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of~Any unexplained death within the first 30 days or~Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|0 to 393 Days|Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640754|NCT01751906|Secondary|Number of Participants Experienced Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|≤ 7 days post index procedure (In-hospital )|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640738|NCT01751906|Secondary|Number of Participants With Very Late Stent /Scaffold Thrombosis (Per ARC Definition)|"Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing :~Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.~Evidence:~Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.~Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of~Any unexplained death within the first 30 days or~Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|366 to 393 Days|Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640739|NCT01751906|Secondary|Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition)|"Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing :~Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.~Evidence:~Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.~Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|5 years||2020-05-31|05/2020||||
2640740|NCT01751906|Secondary|Number of Participants With Late Scaffold/Stent Thrombosis (Per ARC Definition)|"Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing :~Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.~Evidence:~Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.~Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|4 years||2019-12-31|12/2019||||
2640741|NCT01751906|Secondary|Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)|"Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing :~Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.~Evidence:~Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.~Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of~Any unexplained death within the first 30 days or~Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|31 to 365 Days|Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640742|NCT01751906|Secondary|Number of Participants With Stent/Scaffold Thrombosis (Per ARC Definition)|"Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing :~Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.~Evidence:~Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.~Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|394 to 1123 days|Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640755|NCT01751906|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|5 years||2020-05-31|05/2020||||
2640756|NCT01751906|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|4 years||2019-12-31|12/2019||||
2640757|NCT01751906|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 3 years|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2641175|NCT01748071|Primary|Mean Value of Narco-trend Index|According to the measurement of Nacro-trend index after intravenous injection of opioid analgesics. Narco-trend index is from 0 to 100 which 0 represent deep sedation, and 100 represent waking state.|10 minutes after the procedure||||units on a scale||Standard Deviation|Mean
2640743|NCT01751906|Secondary|Number of Participants With Stent/Scaffold Thrombosis (Per ARC Definition)|"Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing :~Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.~Evidence:~Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.~Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|759 to 1123 days|Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640744|NCT01751906|Secondary|Number of Participants With Subacute Stent/Scaffold Thrombosis|"Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing :~Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.~Evidence:~Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.~Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of~Any unexplained death within the first 30 days or~Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|>1 to 30 Days|Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640745|NCT01751906|Secondary|Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis (Per ARC Definition)|"Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing :~Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.~Evidence:~Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.~Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of~Any unexplained death within the first 30 days or~Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|0 to 30 Days|Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640746|NCT01751906|Secondary|Number of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition)|"Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab.~Timing :~Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation.~Evidence:~Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation.~Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of~Any unexplained death within the first 30 days or~Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause."|≤ 1 Day|Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640747|NCT01751906|Secondary|Number of Participants Experienced Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|5 years||2020-05-31|05/2020||||
2640748|NCT01751906|Secondary|Number of Participants Experienced Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|4 years||2019-12-31|12/2019||||
2640749|NCT01751906|Secondary|Number of Participants Experienced Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|0 to 3 years|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640750|NCT01751906|Secondary|Number of Participants Experienced Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|0 to 2 years|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640751|NCT01751906|Secondary|Number of Participants Experienced Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|0 to 1 year|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640752|NCT01751906|Secondary|Number of Participants Experienced Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.|0 to 180 days|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640758|NCT01751906|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 2 years|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640759|NCT01751906|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 1 year|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
2640760|NCT01751906|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 180 days|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
2640761|NCT01751906|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|0 to 30 days|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
2640762|NCT01751906|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|≤ 7 days post index procedure (In-hospital )|ITT population. Analysis population excludes subjects who are truly lost-to-followup,defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization,respectively).|||Participants|||Count of Participants
2640763|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|5 years||2020-05-31|05/2020||||
2640764|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|4 years||2019-12-31|12/2019||||
2640765|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|0 to 3 years|Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640766|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|0 to 2 years|Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640767|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|0 to 1 year|ITT population. Analysis population excludes subjects who are truly lost-to-followup, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization,respectively).|||Participants|||Count of Participants
2640768|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|0 to 180 days|Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640769|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|0 to 30 days|Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640770|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|≤ 7 days post index procedure (In-hospital )|Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640771|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|5 years||2020-05-31|05/2020||||
2640772|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|4 years||2019-12-31|12/2019||||
2640773|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 3 years|Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2641176|NCT01748071|Primary|Mean Pressure Pain Threshold|According to the measurement of pressure pain threshold after intravenous injection of opioid analgesics|10 minutes after the procedure||||kg/cm2||Standard Deviation|Mean
2640774|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 2 years|Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640775|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 1 year|Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640776|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 180 days|Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640777|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|0 to 30 days|Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640778|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|≤ 7 days post index procedure (In-hospital )|Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640779|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|5 years||2020-05-31|05/2020||||
2640780|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|4 years||2019-12-31|12/2019||||
2640781|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 3 years|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640782|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 2 years|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640783|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 1 year|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
2640803|NCT01751906|Secondary|Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|5 years||2020-05-31|05/2020||||
2640784|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 180 days|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
2640785|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 30 days|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
2640786|NCT01751906|Secondary|Number of Participants Experienced Cardiac Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|≤ 7 days post index procedure (In-hospital )|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
2640787|NCT01751906|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|5 years||2020-05-31|05/2020||||
2640788|NCT01751906|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|4 years||2019-12-31|12/2019||||
2640789|NCT01751906|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 3 years|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640790|NCT01751906|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 2 years|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640804|NCT01751906|Secondary|Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|4 years||2019-12-31|12/2019||||
2640791|NCT01751906|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 1 year|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
2640792|NCT01751906|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 180 days|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
2640793|NCT01751906|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|0 to 30 days|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
2640794|NCT01751906|Secondary|Number of Participants Experienced Death/All MI|"All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Those MIs which are not Q-wave MI"|≤ 7 days post index procedure (In-hospital )|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
2640795|NCT01751906|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|5 years||2020-05-31|05/2020||||
2640796|NCT01751906|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|4 years||2019-12-31|12/2019||||
2640797|NCT01751906|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|0 to 3 years|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640798|NCT01751906|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|0 to 2 years|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640799|NCT01751906|Secondary|Number of Participants With Powered Secondary Endpoint: All Revascularization|This powered secondary endpoint is intended to assess all revascularization at 1 year and test for superiority of Absorb BVS to XIENCE. All revascularizations are comprised of TLR, TVR excluding TLR, and non-TVR.|0 to 1 year|ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through 1 year without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).|||Participants|||Count of Participants
2640800|NCT01751906|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|0 to 180 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640801|NCT01751906|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|0 to 30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640802|NCT01751906|Secondary|Number of Participants With All Revascularization|All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.|≤ 7 days post index procedure (In-hospital )|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2641177|NCT01748045|Secondary|Total Duration of Respiratory Support|participants were followed for the duration of hospital stay for respiratory support|From hospital admission through discharge||||days||Standard Deviation|Mean
2640805|NCT01751906|Secondary|Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|0 to 3 years|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640806|NCT01751906|Secondary|Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|0 to 2 years|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640807|NCT01751906|Secondary|Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~Target Vessel Revascularization (TVR,) excluding TLR includes:~ID-TVR excluding TLR.~Non-ID TVR excluding TLR."|0 to 1 year|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640808|NCT01751906|Secondary|Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~Target Vessel Revascularization (TVR,) excluding TLR includes:~ID-TVR excluding TLR.~Non-ID TVR excluding TLR."|0 to 180 days|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640809|NCT01751906|Secondary|Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~Target Vessel Revascularization (TVR,) excluding TLR includes:~ID-TVR excluding TLR.~Non-ID TVR excluding TLR."|0 to 30 days|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640810|NCT01751906|Secondary|Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)|"TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.~Target Vessel Revascularization (TVR,) excluding TLR includes:~ID-TVR excluding TLR.~Non-ID TVR excluding TLR."|≤ 7 days post index procedure (In-hospital )|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640811|NCT01751906|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent."|5 years||2020-05-31|05/2020||||
2640812|NCT01751906|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent."|4 years||2019-12-31|12/2019||||
2640813|NCT01751906|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent."|0 to 3 years|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640814|NCT01751906|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent."|0 to 2 years|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640815|NCT01751906|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent."|0 to 1 year|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2641293|NCT01747330|Primary|Height|change from baseline at day 84|3 months|Full Analysis subject sample|||m||Standard Deviation|Mean
2640816|NCT01751906|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent."|0 to 180 days|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640817|NCT01751906|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent."|0 to 30 days|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640818|NCT01751906|Secondary|Number of Participants With All Target Lesion Revascularization (TLR)|"TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent."|≤ 7 days post index procedure (In-hospital )|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640819|NCT01751906|Secondary|Number of Participants With All Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|5 years||2020-05-31|05/2020||||
2640820|NCT01751906|Secondary|Number of Participants With All Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|4 years||2019-12-31|12/2019||||
2640821|NCT01751906|Secondary|Number of Participants With All Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|0 to 3 years|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640822|NCT01751906|Secondary|Number of Participants With All Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|0 to 2 years|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640823|NCT01751906|Secondary|Number of Participants With All Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|0 to 1 year|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640824|NCT01751906|Secondary|Number of Participants With All Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|0 to 180 days|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640825|NCT01751906|Secondary|Number of Participants With All Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|0 to 30 days|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640826|NCT01751906|Secondary|Number of Participants With All Myocardial Infarction (MI)|"Attributable to target vessel (TV-MI)~Not attributable to target vessel (NTV-MI)"|≤ 7 days post index procedure (In-hospital )|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640827|NCT01751906|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|5 years||2020-05-31|05/2020||||
2640828|NCT01751906|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|4 years||2019-12-31|12/2019||||
2640836|NCT01751906|Secondary|Number of Participants With Powered Secondary Endpoint: Angina|Angina is defined as the first adverse event resulting in the site diagnosis of angina.|1 year|The analysis will exclude angina following the index procedure through discharge, not to exceed a period of 7 days. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640880|NCT01751646|Secondary|Change From Baseline to Week 48 in SPO4||Baseline and wk 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||mg/dL||Inter-Quartile Range|Median
2640829|NCT01751906|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 3 years|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640830|NCT01751906|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 2 years|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640831|NCT01751906|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 1 year|ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640832|NCT01751906|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 180 days|Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640833|NCT01751906|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|0 to 30 days|Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640834|NCT01751906|Secondary|Number of Participants Experienced Death (Cardiac, Vascular, Non-cardiovascular)|"DEATH (Per Academic Research Consortium (ARC)) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|≤ 7 days post index procedure (In-hospital )|Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640835|NCT01751906|Secondary|Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR)|This powered secondary endpoint is intended to assess all ID-TVR at 1 year and test for superiority of Absorb BVS to XIENCE.|1 year|For ID-TVR, Fisher’s exact test is used for superiority testing based on the ITT population. This analysis will include ~2000 subjects. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2640911|NCT01751646|Secondary|Change From Baseline to Week 24 in Serum Calcium (SCa)||24 weeks||||mg/dL||Inter-Quartile Range|Median
2640837|NCT01751906|Secondary|Acute Success: Procedural Success (Subject Level Analysis)|Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).|On day 0 (the day of procedure)|Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640838|NCT01751906|Secondary|Acute Success- Device Success (Lesion Level Analysis)|Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.|On day 0 (the day of procedure)|Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Percentage of lesions|Target Lesions||Number
2640839|NCT01751906|Primary|Number of Participants Experienced Cardiac Death/TV-MI/ID-TLR (TLF)|TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).|1 year|Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2640840|NCT01751867|Secondary|Mean Change From Baseline to End of Treatment in Scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ C-30) Physical Functioning Scale|"EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from 1 = not at all to 4 = very much. Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which will be rated on a 7-point scale ranging from 1 = very poor to 7 = excellent. Lower scores indicate worsening. Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning."|Baseline to end of treatment (approximately up to 2 years)|Intent-to-treat (ITT) population- Participants who received at least one dose of study drug. The missing data was imputed by the Last Observation Carried Forward (LOCF).|||Scores on a scale||Standard Deviation|Mean
2640841|NCT01751867|Secondary|Overall Survival Rate: Percentage of Participants Who Survived During 6 Months and 12 Months of Treatment.||From the date of dosing until death or lost to follow-up for up to 2.5 years after last patient was enrolled|Intent-to-treat (ITT) population- Participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2640842|NCT01751867|Secondary|Mean Percentage of Duration of Hospitalization (Relative to Days on Study Treatment)|Duration of hospitalization was calculated as, total number of days a participant stayed in hospital during study treatment divided by the study treatment duration|Up to 2 years|Intent-to-treat (ITT) population: Participants who received at least one dose of study drug.|||Percentage of total days||Standard Deviation|Mean
2640843|NCT01751867|Secondary|Transfusion Independence: Number of Participants Who Were Transfusion Independent|A participant was considered to be transfusion independent, if the participant had no transfusions of Red Blood Cells (RBCs) or platelets for 8 consecutive weeks or more.|Baseline; up to 2 years|Intent-to-treat (ITT) population: Participants who received at least one dose of study drug. Here, 'n' is the number of participants analyzed at specified time point.|||Participants|||Number
2640844|NCT01751867|Secondary|Cytogenetic Response Rate: Percentage of Participants Who Achieved Cytogenetic Response (Complete+Partial) by Status of Clinical Overall Response - International Working Group (IWG) 2006 Response Criteria|As per IWG 2006 response criteria - Complete cytogenetic response: disappearance of the chromosomal abnormality without appearance of new ones; Partial cytogenetic response: At least 50% reduction of the chromosomal abnormality. Status of Clinical response - complete remission (CR); marrow CR (mCR); partial remission (PR).|From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation|Participants who had baseline cytogenetic abnormality and had at least one post baseline cytogenetic assessments during study.|||Percentage of Participants|||Number
2640845|NCT01751867|Secondary|Hematological Improvement Rate: Number of Participants Who Achieved Complete Remission (CR), Partial Remission (PR) and Hematologic Improvement (HI) - International Working Group (IWG) 2006 Response Criteria|IWG 2006 response criteria - CR: bone marrow evaluation shows <= 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin >= 11 g/dL, neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by >= 50%, still greater than 5% in bone marrow; HI: hemoglobin increase of >= 1.5 g/dL, platelet increase of >= 30,000/mL (starting with > 20,000/mL), neutrophils increase of >= 100% and > 500/μL.|From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation|Intent-to-treat (ITT) population- Participants who received at least one dose of study drug.|||Participants|||Number
2640846|NCT01751867|Primary|Overall Response Rate (ORR): Number of Participants Who Achieved Either Complete Remission (CR), Partial Remission (PR), or Marrow Complete Remission (mCR) - International Working Group (IWG) 2006 Response Criteria|IWG 2006 response criteria - CR: bone marrow evaluation shows less than or equal to (<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin >= 11 gram per deciliter (g/dL), neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by >=50%, still greater than 5% in bone marrow.|From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation|Intent-to-treat (ITT) population: Participants who received at least one dose of study medication.|||Participants|||Number
2640879|NCT01751646|Secondary|Change From Baseline to Week 12 in UCa/Ucr||Baseline and wk 12|Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||ratio||Inter-Quartile Range|Median
2640847|NCT01751802|Secondary|Safety Summary of Ecopipam in Patients With Lesch-Nyhan Disease: Total Number of Serious and Non-Serious Adverse Events Experienced During 3 Double-blind Crossover Periods|An additional objective of the study is to assess the safety of ecopipam in subjects with LND for up to 52 weeks. Total number of serious and non-serious adverse events experienced by participants while receiving ecopipam or placebo. For additional detail, see Adverse Events|Total duration over which participants recieved double-blind ecopipam or placebo, up to 6 or 12 weeks|All participants who received at least one dose|||adverse events|||Number
2640848|NCT01751802|Secondary|Effect of Ecopipam Withdrawal and Maintenance|The secondary objectives of this study are to assess the effect of withdrawal and maintenance of ecopipam's effects in subjects with LND. Measured by the number of participants whose score changes significantly from baseline on ecopipam or placebo|Baseline, 6 weeks, 12 weeks, 18 weeks|0 participants analyzed because data are not reliable||||||
2640849|NCT01751802|Primary|Behavior Problems Inventory - Self-Injurious Behavior Subscale|The primary endpoint is the BPI (SIB subscales - total for frequency and severity) as assessed by the caregiver. BPI Self-Injurious Behavior Subscale ranges from 0 to 45, with higher scores indicating more self-injurious behavior.|Baseline, end of period 1 (6 weeks), end of period 2 (12 weeks), end of period 3 (18 weeks),|All participants who completed the BPI-Self Injurious Behavior survey for 3 or more time points|||scores on a scale||Standard Deviation|Mean
2640850|NCT01751724|Other Pre-specified|Number of Infants With Severe Retinopathy of Prematurity|Severe retinopathy of prematurity defined as stage 3 or higher|From enrollment until 36 weeks postmenstrual age, discharge or death||||Participants|||Count of Participants
2640851|NCT01751724|Other Pre-specified|Number of Infants With Severe Intraventricular Hemorrhage|Severe intraventricular hemorrhage defined as grade III or higher|From enrollment until 36 weeks postmenstrual age, discharge or death||||Participants|||Count of Participants
2640852|NCT01751724|Other Pre-specified|Number of Infants With Septicemia|Septicemia defined as positive blood culture|From enrollment until 36 weeks postmenstrual age, discharge or death||||Participants|||Count of Participants
2640853|NCT01751724|Other Pre-specified|Number of Infants With Necrotizing Enterocolitis||From enrollment until 36 weeks postmenstrual age, discharge or death||||Participants|||Count of Participants
2640854|NCT01751724|Other Pre-specified|Number of Infants With Pulmonary Hemorrhage||From enrollment until 36 weeks postmenstrual age, discharge or death||||Participants|||Count of Participants
2640855|NCT01751724|Secondary|Survival Without BPD|Discharge alive without BPD. BPD defined as need for oxygen for at least 28 days and at 36 weeks post-menstrual age.|From the time of randomization until 36 weeks corrected age, discharge or death||||Participants|||Count of Participants
2640856|NCT01751724|Secondary|Number of Infants With Bronchopulmonary Dysplasia (BPD)|BPD defined as need for oxygen for at least 28 days and at 36 weeks post-menstrual age.|Evaluated at 36 weeks corrected postmenstrual age|Infants alive at 36 weeks postmenstrual age|||Participants|||Count of Participants
2640857|NCT01751724|Secondary|Total Duration of Oxygen Supplementation||From the time of first initiation until the last day of oxygen supplementation, up to 36 weeks corrected age|Infants alive at 36 weeks postmenstrual age|||days||Inter-Quartile Range|Median
2640858|NCT01751724|Secondary|Total Duration of Mechanical Ventilation||From the time of first intubation until the last extubation, up to 36 weeks corrected age|Infants alive at 36 weeks postmenstrual age|||days||Inter-Quartile Range|Median
2640859|NCT01751724|Secondary|Survival||From the time of randomization up to 36 weeks corrected age, or until the time of discharge or death||||Participants|||Count of Participants
2640860|NCT01751724|Primary|Age at First Successful Extubation|Defined as age of extubation with infant remaining extubated for more than 24 hours.|From birth to until 36 weeks postmenstrual age||||days||Inter-Quartile Range|Median
2640861|NCT01751646|Secondary|Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Ritonavir Use|Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use|Baseline and wk 48|Authors were interested in comparing the change in mean 25-OHD from baseline to wk 48 by those who used ritonavir vs those who did not use ritonavir; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section.|||ng/mL||Standard Deviation|Mean
2640862|NCT01751646|Secondary|Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Week 48 by Ritonavir Use|Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use|Week 48|Authors were interested in comparing mean 25-OHD at wk 48 by those who used ritonavir vs those who did not use ritonavir; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section.|||ng/mL||Standard Deviation|Mean
2640863|NCT01751646|Secondary|Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Baseline by Ritonavir Use|Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use|Baseline|Authors were interested in comparing mean 25-OHD at baseline by those who used ritonavir vs those who did not use ritonavir; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section.|||ng/mL||Standard Deviation|Mean
2640864|NCT01751646|Secondary|Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Efavirenz Use|Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use|Baseline and wk 48|Authors were interested in comparing the change in mean 25-OHD from baseline to wk 48 by those who used efavirenz vs those who did not use efavirenz; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section.|||ng/mL||Standard Deviation|Mean
2640865|NCT01751646|Secondary|Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Week 48 by Efavirenz Use|Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use|Week 48|Authors were interested in comparing mean 25-OHD at wk 48 by those who used efavirenz vs those who did not use efavirenz; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section.|||ng/mL||Standard Deviation|Mean
2640866|NCT01751646|Secondary|Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Baseline by Efavirenz Use|Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use|Baseline|Authors were interested in comparing mean 25-OHD at baseline by those who used efavirenz vs those who did not use efavirenz; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section.|||ng/mL||Standard Deviation|Mean
2640867|NCT01751646|Secondary|25-OHD Serum Concentration by Randomized Study Group at Week 48||Week 48|Subjects who had wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||ng/mL||Inter-Quartile Range|Median
2640868|NCT01751646|Secondary|25-OHD Serum Concentration by Randomized Study Group at Week 24||Week 24|Subjects who had wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||ng/mL||Inter-Quartile Range|Median
2640869|NCT01751646|Secondary|25-OHD Serum Concentration by Randomized Study Group at Week 12||Week 12|Subjects who had wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||ng/mL||Inter-Quartile Range|Median
2640870|NCT01751646|Secondary|Change in UProt/ UCr Ratio From Baseline to Week 48|To assess renal tubular function by measuring change in urinary protein to creatinine ratio by randomized study group;|Baseline and wk 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||ratio||Inter-Quartile Range|Median
2640871|NCT01751646|Secondary|Change in UB2MG From Baseline to Week 48|To assess renal tubular function by measuring change in urine beta-2 microglobulin (UB2MG) by randomized study group;|Baseline and wk 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||mcg/L||Inter-Quartile Range|Median
2640872|NCT01751646|Secondary|Change in URBP/UCr Ratio From Baseline to Week 48|To assess renal tubular function by measuring change in urine retinol binding protein to urine creatinine (URBP/UCr) ratio by randomized study group;|Baseline and wk 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||mcg/g||Inter-Quartile Range|Median
2640873|NCT01751646|Secondary|Change in UGluc From Baseline to Week 48|To assess renal tubular function by measuring change in urine glucose (UGluc) by randomized study group;|Baseline and wk 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||mg/dL||Inter-Quartile Range|Median
2640874|NCT01751646|Secondary|Change in Estimated GFR From Baseline to Week 48.|To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 48 by randomized study group;|Baseline and wk 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||ml/min/1.73m^2||Inter-Quartile Range|Median
2640875|NCT01751646|Secondary|Change in Estimated GFR From Baseline to Week 24.|To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 24 by randomized study group;|Baseline and wk 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||ml/min/1.73m^2||Inter-Quartile Range|Median
2640876|NCT01751646|Secondary|Change in Estimated GFR From Baseline to Week 12.|"To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 12 by randomized study group.~eGFR calculated by the CKD-Epi equation for subjects >=18 years of age, and by bedside Schwartz formula for subjects <18 years of age"|Baseline and wk 12|Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||ml/min/1.73m^2||Inter-Quartile Range|Median
2640877|NCT01751646|Secondary|Change From Baseline to Week 48 in UCa/Ucr||Baseline and wk 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||ratio||Inter-Quartile Range|Median
2640878|NCT01751646|Secondary|Change From Baseline to Week 24 in UCa/Ucr||Baseline and wk 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||ratio||Inter-Quartile Range|Median
2640935|NCT01751412|Secondary|Late Toxicities|Late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, esophageal stricture, myelopathy, thyroid dysfunction and secondary cancers.|5 years|The trial was terminated before the study endpoint was met. The data is not available for analysis.||||||
2640881|NCT01751646|Secondary|Change From Baseline to Week 24 in SPO4||Baseline and wk 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||mg/dL||Inter-Quartile Range|Median
2640882|NCT01751646|Secondary|Change From Baseline to Week 12 in SPO4||Baseline and wk 12|Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||mg/dL||Inter-Quartile Range|Median
2640883|NCT01751646|Secondary|Change From Baseline to Week 48 in TRP %||Baseline and wk 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||percent||Inter-Quartile Range|Median
2640884|NCT01751646|Secondary|Change From Baseline to Week 24 in TRP %||Baseline and wk 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||percent||Inter-Quartile Range|Median
2640885|NCT01751646|Secondary|Change From Baseline to Week 12 in TRP %||Baseline and wk 12|Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||percent||Inter-Quartile Range|Median
2640886|NCT01751646|Secondary|Change From Baseline to Week 48 in 25-OHD||Baseline and wk 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||ng/ML||Inter-Quartile Range|Median
2640887|NCT01751646|Secondary|Change From Baseline to Week 24 in 25-OHD||Baseline and wk 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||ng/ML||Inter-Quartile Range|Median
2640888|NCT01751646|Secondary|Change From Baseline to Week 12 in 25-OHD||Baseline and wk 12|Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||ng/ML||Inter-Quartile Range|Median
2640889|NCT01751646|Secondary|Change From Baseline to Week 48 in 1,25-OHD||Baseline and wk 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||pg/ML||Inter-Quartile Range|Median
2640890|NCT01751646|Secondary|Change From Baseline to Week 24 in 1,25-OHD||Baseline and wk 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||pg/ML||Inter-Quartile Range|Median
2640891|NCT01751646|Secondary|Change From Baseline to Week 12 in 1,25-OHD||Baseline and wk 12|Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||pg/ML||Inter-Quartile Range|Median
2640892|NCT01751646|Secondary|Change From Baseline to Week 48 in Actual Free 1,25-OHD|Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd * [VDBP] + Ka *[albumin]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L|Baseline and wk 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||fmol/L||Inter-Quartile Range|Median
2640893|NCT01751646|Secondary|Change From Baseline to Week 24 in Actual Free 1,25-OHD|Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd * [VDBP] + Ka *[albumin]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L|Baseline and wk 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||fmol/L||Inter-Quartile Range|Median
2640894|NCT01751646|Secondary|Change From Baseline to Week 12 in Actual Free 1,25-OHD|Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd * [VDBP] + Ka *[albumin]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L|Baseline and wk 12|Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||fmol/L||Inter-Quartile Range|Median
2640895|NCT01751646|Secondary|Change From Baseline to Week 48 in PTH||Baseline and wk 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||pg/ML||Inter-Quartile Range|Median
2640896|NCT01751646|Secondary|Change From Baseline to Week 24 in PTH||Baseline and wk 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||pg/ML||Inter-Quartile Range|Median
2640897|NCT01751646|Secondary|Change From Baseline to Week 12 in PTH||Baseline and wk 12|Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||pg/ML||Inter-Quartile Range|Median
2640898|NCT01751646|Secondary|Change From Baseline to Week 48 in FGF23||Baseline and wk 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||pg/ML||Inter-Quartile Range|Median
2640899|NCT01751646|Secondary|Change From Baseline to Week 24 in FGF23||Baseline and wk 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||pg/ML||Inter-Quartile Range|Median
2640900|NCT01751646|Secondary|Change From Baseline to Week 12 in FGF23||Baseline and wk 12|Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||pg/ML||Inter-Quartile Range|Median
2640901|NCT01751646|Secondary|Change From Baseline to Week 48 in BAP||Baseline and wk 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||U/L||Inter-Quartile Range|Median
2640902|NCT01751646|Secondary|Change From Baseline to Week 24 in BAP||Baseline and wk 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||U/L||Inter-Quartile Range|Median
2640903|NCT01751646|Secondary|Change From Baseline to Week 12 in BAP||Baseline and wk 12|Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||U/L||Inter-Quartile Range|Median
2640904|NCT01751646|Secondary|Change From Baseline to Week 48 in OC||Baseline and wk 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||mcg/L||Inter-Quartile Range|Median
2640905|NCT01751646|Secondary|Change From Baseline to Week 24 in OC||Baseline and week 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.|||mcg/L||Inter-Quartile Range|Median
2640906|NCT01751646|Secondary|Change From Baseline to Week 12 in OC||Baseline and week 12|Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.|||mcg/L||Inter-Quartile Range|Median
2640907|NCT01751646|Secondary|Change From Baseline to Week 48 in CTX||Baseline and week 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||mcg/L||Inter-Quartile Range|Median
2640908|NCT01751646|Secondary|Change From Baseline to Week 24 in CTX||Baseline and week 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||mcg/L||Inter-Quartile Range|Median
2640909|NCT01751646|Secondary|Change From Baseline to Week 12 in CTX||Baseline and week 12|Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||mcg/L||Inter-Quartile Range|Median
2640910|NCT01751646|Secondary|Change From Baseline to Week 48 in Serum Calcium (SCa)||Baseline and wk 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||mg/dL||Inter-Quartile Range|Median
2640912|NCT01751646|Secondary|Change From Baseline to Week 12 in Serum Calcium (SCa)||Baseline and wk 12|Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||mg/dL||Inter-Quartile Range|Median
2640913|NCT01751646|Secondary|Change From Baseline to Week 48 in Glucose Homeostasis (Homeostasis Model Assessment of Insulin Resistance (HOMA-IR))|"HOMA-IR is calculated as fasting glucose (mg/dL) X fasting glucose (uIU/mL) / 405. An increase in HOMA-IR means that an individual has become more resistant (less sensitive) to the effects of insulin and thus would be a negative outcome. A reduction in HOMA-IR means that an individual has become more sensitive to the effects of insulin and would be considered a positive outcome.There are no set minimum or maximum scores for HOMA-IR, since it is based on measurements of insulin and glucose, the assays for which may vary. Several studies suggest a cut-off of >2 for any insulin resistance, but normal values appear to vary greatly by population (https://www.mdcalc.com/homa-ir-homeostatic-model-assessment-insulin-resistance)."|Baseline and week 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.|||units on a scale||Inter-Quartile Range|Median
2640914|NCT01751646|Secondary|Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Glucose)||Baseline and week 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.|||mg/dL||Inter-Quartile Range|Median
2640915|NCT01751646|Secondary|Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Insulin)||Baseline and 48 weeks|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.|||uIU/mL||Inter-Quartile Range|Median
2640916|NCT01751646|Secondary|Change in SCr From Baseline to Week 48.|To assess renal glomerular safety by measuring change in SCr from baseline to week 48 by randomized study group;|Baseline and week 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.|||mg/dL||Inter-Quartile Range|Median
2640917|NCT01751646|Secondary|Change in SCr From Baseline to Week 24.|To assess renal glomerular safety by measuring change in SCr from baseline to week 24 by randomized study group;|Baseline and week 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||mg/dL||Inter-Quartile Range|Median
2640918|NCT01751646|Secondary|Change in SCr From Baseline to Week 12.|To assess renal glomerular safety by measuring change in SCr from baseline to week 12 by randomized study group;|Baseline and week 12|Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.|||mg/dL||Inter-Quartile Range|Median
2640919|NCT01751646|Secondary|Change From Baseline to Week 48 of Total Hip BMD Z-score for the Randomized Study Groups|The Z-score is the standard deviation around mean bone mineral density in the total hip, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.|Baseline and week 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.|||z-score||Inter-Quartile Range|Median
2640920|NCT01751646|Secondary|Change From Baseline to Week 24 of Total Hip BMD Z-score for the Randomized Study Groups|The Z-score is the standard deviation around mean bone mineral density in the total hip, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.|Baseline and week 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.|||z-score||Inter-Quartile Range|Median
2640921|NCT01751646|Secondary|Percent Change From Baseline to Week 48 of Total Hip BMD for the Randomized Study Groups||Baseline and week 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.|||percent change||Inter-Quartile Range|Median
2640922|NCT01751646|Secondary|Percent Change From Baseline to Week 24 of Total Hip BMD for the Randomized Study Groups||Baseline and week 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.|||percent change||Inter-Quartile Range|Median
2641294|NCT01747330|Primary|Body Weight|change from baseline at day 84|3 months|Full Analysis subject sample|||kg||Standard Deviation|Mean
2640923|NCT01751646|Secondary|Change From Baseline to Week 48 of Femoral Neck BMD Z-score for the Randomized Study Groups|The Z-score is the standard deviation around mean bone mineral density in the femoral neck, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.|Baseline and week 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.|||z-score||Inter-Quartile Range|Median
2640924|NCT01751646|Secondary|Change From Baseline to Week 24 of Femoral Neck BMD Z-score for the Randomized Study Groups|The Z-score is the standard deviation around mean bone mineral density in the femoral neck, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.|Baseline and week 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.|||z-score||Inter-Quartile Range|Median
2640925|NCT01751646|Secondary|Percent Change From Baseline to Week 48 of Femoral Neck BMD for the Randomized Study Groups||Baseline and week 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.|||percent change||Inter-Quartile Range|Median
2640926|NCT01751646|Secondary|Percent Change From Baseline to Week 24 of Femoral Neck BMD for the Randomized Study Groups||Baseline and week 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.|||percent change||Inter-Quartile Range|Median
2640927|NCT01751646|Secondary|Change From Baseline to Week 48 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups|The Z-score is the standard deviation around mean bone mineral density in the lumbar spine, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.|Baseline and week 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.|||z-score||Inter-Quartile Range|Median
2640928|NCT01751646|Secondary|Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups|The Z-score is the standard deviation around mean bone mineral density in the lumbar spine, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.|Baseline and week 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.|||z-score||Inter-Quartile Range|Median
2640929|NCT01751646|Secondary|Percent Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD for the Randomized Study Groups||Baseline and week 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.|||percent change||Inter-Quartile Range|Median
2640930|NCT01751646|Secondary|Percent Change From Baseline to Week 48 of BMC of Whole Body for the Randomized Study Groups||Baseline and week 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.|||percent change||Inter-Quartile Range|Median
2640931|NCT01751646|Secondary|Percent Change From Baseline to Week 24 of BMC of Whole Body for the Randomized Study Groups||Baseline and week 24|Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be greater than the number completed in the Participant Flow section.|||percent change||Inter-Quartile Range|Median
2640932|NCT01751646|Primary|Percent Change From Baseline to Week 48 in Dual Energy X-ray Absorptiometry (DXA)-Measured BMD at the Spine for the Randomized Study Groups|"Percent change from baseline to week (wk) 48 in DXA-measured BMD at the spine for the randomized study groups.~Lumbar spine BMD (L1 - L4) (g/cm2) change from Baseline to wk 48 visit."|Baseline and wk 48|Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be greater than the number completed in the Participant Flow section.|||percent change||Inter-Quartile Range|Median
2640933|NCT01751412|Secondary|6-Month Progression-Free Survival|The number of participants surviving without disease progression six months after the start of treatment|6 Months||||Participants|||Count of Participants
2640934|NCT01751412|Secondary|6-Month Overall Survival|The number of participants surviving six months after starting treatment|6 Months||||Participants|||Count of Participants
2640937|NCT01751412|Secondary|Local Control|The number of participants who maintained local control for the duration of their followup. Local control is defined as the lack of disease progression. Progression is the increased growth of cancer cells or the spread of the cancer cells to another location within the body.|2 years||||Participants|||Count of Participants
2640938|NCT01751412|Primary|Radiation Dose to the Normal Tissue of the Lungs|The percentage of the lung volume which received radiation dose of 20 Gray (Gy) or more. The lung volume percentages for the 12 participants were averaged and presented separately for the left and right lungs.|6 Weeks||||Percentage of Lung Volume||Full Range|Mean
2640939|NCT01751412|Primary|Mean Radiation Dose to Normal Heart Tissue|The mean radiation dose to the heart in Gy RBE (Gray relative biological effectiveness).|6 weeks||||Gy(RBE)||Full Range|Mean
2640940|NCT01751399|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2605541||Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose|All participants who received 1 dose of LY2605541 and had evaluable Cmax data.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2640941|NCT01751399|Primary|Pharmacokinetics: Area Under the Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY2605541||Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose|All participants who received 1 dose of LY2605541 and had evaluable AUC(0-∞) data.|||picomole*hours/liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2640942|NCT01751386|Primary|Total Amount of Alcohol Consumed During the Alcohol Self Administration (ASA) Session|Amount of alcohol was measured as the number of mini-drinks each participant decided to drink (0-8 mini-drinks). The alcohol content of each mini-drink was calculated based on the participants' total body water, and was designed to raise the blood alcohol concentration by 0.015 g/dL.|2 hours|The analysis included all subjects who took the medication (either baclofen or placebo) and finished the alcohol laboratory session|||mini-drinks||Standard Error|Mean
2640943|NCT01751308|Secondary|Phase 2: Overall Survival (OS)|OS was defined as the time (in months) from the date of first dose administration until the date of death (from any cause). If death was not observed, the participant was censored at the earliest of the last date the participant was known to be alive and the study cut-off date. The analysis was performed by Kaplan-Meier method.|Baseline up to death or study cut-off (maximum duration: 12.1 weeks)|Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint.|||months||95% Confidence Interval|Median
2640944|NCT01751308|Secondary|Phase 2: Progression Free Survival (PFS)|The PFS was defined as the time (in months) from the date of first dose administration until the date of first documented PD or death (from any cause), whichever came first. If progression or death was not observed, the participant was censored at the date of the participant's last progression-free tumor assessment prior to the study cut-off date. PD as per RANO criteria was defined as ≥25% increase in the product of perpendicular diameters of any target lesion, taking as reference the smallest product observed since the start of treatment or the appearance of one or more new lesions, or worsening neurologic status not explained by causes unrelated to tumor progression (example, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, presumed post-therapy swelling etc) plus any increase in tumor cross-sectional area (or tumor volume). The analysis was performed by Kaplan-Meier method.|Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks)|Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint.|||months||95% Confidence Interval|Median
2640945|NCT01751308|Secondary|Phase 1 and 2: PK Parameter of Cabazitaxel: Maximum Plasma Concentration Observed (Cmax)|Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.|Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI|Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint.|||ng/mL||Standard Deviation|Mean
2640946|NCT01751308|Secondary|Phase 1 and 2: PK Parameter of Cabazitaxel: Volume of Distribution at Steady State (Vss)|Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.|Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI|Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint.|||L/m^2||Standard Deviation|Mean
2640947|NCT01751308|Secondary|Phase 1 and 2: PK Parameter of Cabazitaxel: Total Plasma Clearance (CL)|Blood samples for PK parameters were collected at 5 minutes before EOI, 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.|Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI|Analysis was performed on PK population (for both Phase 1 and Phase 2 parts of the study). Number of participants analyzed=participants with available data for this endpoint.|||L/h/m^2||Standard Deviation|Mean
2640948|NCT01751308|Secondary|Phase 1 and 2: Pharmacokinetics (PK) Parameter of Cabazitaxel: Area Under the Plasma Concentration (AUC) Versus Time Curve|Blood samples for PK parameters were collected at 5 minutes before end of infusion (EOI), 10 minutes, 30 minutes, 3 hours, 7 hours and 71 hours after the EOI on Day 1 of Cycle 1.|Day 1 of Cycle 1: 5 minutes before EOI up to 71 hours after the EOI|PK population (for both Phase 1 and Phase 2 parts of the study) included all participants who received treatment on Day 1 of Cycle 1 and had at least one post-dose PK sample. Number of participants analyzed=participants with available data for this endpoint.|||ng.h/mL||Standard Deviation|Mean
2640949|NCT01751308|Secondary|Phase 1: Number of Participants With Objective Response|OR in participants was defined as the participants with a CR or PR after 3 cycles of cabazitaxel treatment and maintained for at least 4 weeks as assessed by response evaluation criteria in solid tumors (RECIST) version 1.1 and RANO criteria for CNS tumors. For solid tumors, as per RECIST 1.1, CR defined as disappearance of all target and non-target lesions (any pathological lymph nodes, must had reduction in short axis to <10 mm); PR defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. For CNS tumors, as per RANO criteria, CR defined as disappearance of all target and non-target lesions; PR defined as a ≥50% decrease in the sum of the products of the two perpendicular diameters of target lesions, compared to baseline measurement.|Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 112.1 weeks)|Analysis was performed on efficacy evaluable population. Number of participants analyzed=participants with available data for this endpoint.|||participants|||Number
2640950|NCT01751308|Secondary|Phase 1 and 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)|AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had a causal relationship with the treatment. Treatment emergent adverse events (TEAEs) were defined as AEs that developed or worsened in grade or became serious during the on-treatment period which was defined as the period from the time of first dose of cabazitaxel until 30 days following the last administration of cabazitaxel.|Baseline up to DP or death due to any cause (maximum duration: 112.1 weeks for Phase 1 and 12.1 weeks for Phase 2)|Analysis was performed on safety population (AT population).|||participants|||Number
2640951|NCT01751308|Primary|Phase 2: Duration of Response (DOR)|DOR defined as time (in days) from date of first response until date of first documented progressive disease (PD) or death (from any cause), whichever came first. If progression or death was not observed, participant was censored at the date of participant's last progression-free tumor assessment prior to study cut-off date. PD as per RANO criteria was defined as ≥ 25% increase in the product of perpendicular diameters of any target lesion, taking as reference the smallest product observed since the start of treatment or the appearance of one or more new lesions, or worsening neurologic status not explained by causes unrelated to tumor progression (example, anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, presumed post-therapy swelling etc.) plus any increase in tumor cross-sectional area (or tumor volume).|Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks)|Due to no objective responses in Stage 1 of Phase 2, the analysis of duration of response was not performed.Hence, the data is not reported.||||||
2640952|NCT01751308|Primary|Phase 2: Percentage of Participants With Objective Response (OR)|OR in participants was defined as the participants with a Complete Response (CR) or Partial Response (PR) after 3 cycles of cabazitaxel treatment and maintained for at least 4 weeks. CR and PR were based on modified response assessment in neuro-oncology (RANO) criteria for participants with CNS tumors. CR was defined as disappearance of all target lesions. PR was defined as ≥50% decrease in the sum of the products of the two perpendicular diameters of target lesions, compared to the baseline measurement.|Baseline, every 9 weeks until DP or death due to any cause (maximum duration: 12.1 weeks)|Efficacy evaluable population was subset of AT population with measurable disease with a baseline and at least one post-baseline tumor evaluation.Number of participants analyzed=participants with available data for this endpoint.|||percentage of participants|||Number
2640953|NCT01751308|Primary|Phase 1: Maximum Tolerated Dose of Cabazitaxel|MTD was highest dose level of cabazitaxel at which no more than 1 of 6 evaluable participants experienced dose limiting toxicities (DLT). DLT defined as an AE or abnormal laboratory values related to study treatment: hematologic DLTs: any Grade(G)4 hematologic toxicity except neutropenia G4 lasting≤7 days,G3 or 4 febrile neutropenia except G3 or 4 febrile neutropenia in absence of granulocyte-colony stimulating factor prophylaxis, G4 thrombocytopenia; non-hematologic DLTs:any G≥3 non-hematologic toxicity except G3 nausea or G3 or4 vomiting, G3 or4 diarrhea,G3 or4 dehydration,G3 fatigue lasting≤7 days, inadequately treated hypersensitivity reactions, elevated transaminases<10* upper limit of normal of ≤7 days, re-treatment delay of>2 weeks due to delayed recovery from toxicity related to study treatment to baseline G or≤ G1(except for alopecia) and platelet transfusion during Cycle1. Grades based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.|Cycle 1 (21 days)|DLT evaluable population defined as a subset of participants in the Phase 1 part of the study from the AT population who received the first dose of cabazitaxel and had sufficient safety evaluations or experienced a DLT during Cycle 1.|||mg/m^2|||Number
2640954|NCT01751230|Post-Hoc|Changes in % Body Fat in WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers.|Changes in % body fat from baseline (week 0) stratified by adherence to the E-Moms intervention and usual care (WIC Moms).|Baseline and 16 weeks|All participants stratified by adherence to the E-Moms intervention and usual care (WIC Moms)|||% body fat||Standard Error|Mean
2640955|NCT01751230|Post-Hoc|Changes in Waist Circumference of WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers|Changes in waist circumference from baseline (week 0) stratified by adherence to the E-Moms intervention and usual care (WIC Moms)|Baseline and 16 weeks|All participants stratified by adherence to the E-Moms intervention and usual care (WIC Moms)|||cm||Standard Error|Mean
2640956|NCT01751230|Post-Hoc|Changes in Hip Circumference of WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers|Changes in hip circumference from baseline (Week 0) stratified by adherence to the E-Moms intervention and usual care (WIC Moms).|Baseline and 16 weeks|All participants stratified by adherence to the E-Moms intervention and usual care (WIC Moms)|||cm||Standard Error|Mean
2640957|NCT01751230|Primary|Body Weight Change|The primary outcome measure is weight change after the 16 week intervention.|Baseline and 16 weeks||||kg||Standard Error|Mean
2640958|NCT01751178|Secondary|Turesky Modification of Quigley & Hein Plaque Index for Interproximal Plaque Scores|Interproximal plaque scores were analyzed on the mesiofacial, distofacial, mesiolingual and distolingual surfaces, and calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth)|Change from baseline to 6 weeks|This analysis was conducted on ITT population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.|||Units on a scale||Standard Error|Mean
2640959|NCT01751178|Secondary|Turesky Modification of Quigley & Hein Plaque Index for Overall Plaque Scores|Overall plaque scores were calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth)|Change from baseline to 6 weeks|This analysis was conducted on the Intent-to-Treat (ITT) population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.|||Units on a scale||Standard Error|Mean
2640960|NCT01751178|Secondary|Gingival Index|The GI was assessed on the facial and lingual surfaces at six sites on each tooth (facial and lingual - distal papillae, margin and mesial papillae). These assessments were performed on all evaluable teeth using moderate pressure sweeping a blunt ended probe, which was engaged in approximately 1 millimetre (mm) into the gingival crevice. The scores could range from 0-3 (0=Absence of inflammation; 1=Mild Inflammation-Slight change in color slight change in texture, no bleeding on probing; 2=Moderate Inflammation -glazing, redness edema and hypertrophy, bleeding on probing; 3= Severe inflammation-marked redness and hypertrophy, tendency for spontaneous bleeding)|Change from baseline to 6 weeks|This analysis was conducted on the Intent-to-Treat (ITT) population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.|||Units on a scale||Standard Error|Mean
2640961|NCT01751178|Primary|Gingival Severity Index (GSI) Based on the Gingival Index (GI)|"Measure of gingival severity averaged across whole mouth site; each site scored 0, 1, 2, 3 based on GI and,~GSI = 0 if GI is 0 or 1 (no bleeding)~GSI = 1 if GI is 1 or 2 (bleeding)"|Change from baseline to 6 weeks|This analysis was conducted on the Intent-to-Treat (ITT) population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.|||Units on a scale||Standard Error|Mean
2640962|NCT01751165|Secondary|Number of Subjects With pIMDs.|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From one month (30 Days) following the last vaccine administration up to study end at Month 24|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
2640963|NCT01751165|Secondary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs).|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From Dose 1 up to one month (30 days) following the last vaccine dose administration (Dose 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
2640964|NCT01751165|Secondary|Number of Days With Solicited General Symptoms.|Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.|During the 7 Days (Day 0-6) following vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Days|||Number
2640965|NCT01751165|Secondary|Number of Days With Solicited Local Symptoms.|Each dose was abbreviated as follows: D1 = Dose 1, D2 = Dose 2.|During the 7 Days (Day 0-6) following vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Days|||Number
2640966|NCT01751165|Secondary|Number of Subjects With SAE(s).|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.|Starting from 30 Days post last vaccine administration up to study end at Month 24|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
2640967|NCT01751165|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity.|From first vaccination up to one month (30 Days) post last vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
2640968|NCT01751165|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|During the 30 Days (Day 0-29) following vaccination|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
2640969|NCT01751165|Secondary|Number of Subjects With Solicited General Symptoms.|"Assessed solicited general symptoms were Fatigue, Gastrointestinal (meaning nausea, vomiting, diarrhoea and/or abdominal pain), Headache, Myalgia, Shivering and Temperature (temperature higher than [≥] 37.5 degrees Celsius [°C]). Any = occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Fatigue = fatigue that prevented normal activity. Grade 3 Gastrointestinal = gastrointestinal that prevented normal every day activities. Grade 3 Headache = headache that prevented normal activity. Grade 3 Myalgia = myalgia that prevented normal activity. Grade 3 Shivering = shivering that prevented normal activity. Grade 3 Temperature = temperature higher than (>) 39.0°C."|During the 7 day period (Days 0-6) following each dose (D)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
2640970|NCT01751165|Secondary|Number of Subjects With Solicited Local Symptoms.|"Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 100 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity."|During the 7 day period (Days 0-6) following each dose (D)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered.|||Subjects|||Number
2640971|NCT01751165|Secondary|Concentrations of Antibodies Against Anti-gE as Determined by ELISA.||Prior (PRE) to vaccination and twelve (M12) post Dose 2|The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects for whom the pre vaccination and one month post dose 2 time point data were obtained from ATP cohort for immunogenicity.|||mIU/mL||95% Confidence Interval|Geometric Mean
2640972|NCT01751165|Primary|Concentrations of Antibodies Against Anti-gE as Determined by ELISA.||At one month (M1) after Dose 2|The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects for whom the pre vaccination and one month post dose 2 time point data were obtained from ATP cohort for immunogenicity.|||mIU/mL||95% Confidence Interval|Geometric Mean
2641965|NCT01740388|Secondary|Microbial Eradication|Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%|Visit 3 (Day 6, 7, or 8)||||participants|||Number
2640973|NCT01751165|Primary|Number of Subjects With Vaccine Response to Anti-glycoprotein E (Anti-gE) Antibodies as Determined by the Enzyme-linked Immunosorbent Assay (ELISA).|"Vaccine response was defined as: for initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.~The objective required a comparison of VRR between 0,6-months and 0,12-months schedules."|At one month (M1) after Dose 2|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2640974|NCT01751139|Secondary|Number of Subjects With Serious Adverse Events (SAEs) Related to a Study Procedure|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject)|Analysis was performed on the Total cohort that included all subjects enrolled in the study.|||Participants|||Count of Participants
2640975|NCT01751139|Secondary|Number of Suspected Dengue Cases With Severity Criteria|"To describe symptoms and spectrum of dengue disease in the study population for the suspected dengue cases, excluding those reported without fever. Suspected symptomatic dengue case= Febrile illness with body temperature ≥ 38°C measured (by any route) on at least two consecutive days and less than 14 days with or without the presence of other dengue symptoms or signs, without an obvious aetiology unrelated to dengue, based on investigator's judgement; Lab-confirmed = laboratory-confirmed symptomatic dengue cases; Probable = probable symptomatic dengue cases; Negative = negative symptomatic dengue cases; Indeterminate = indeterminate symptomatic dengue case( not classified as laboratory confirmed case, probable case or negative case); Severe dengue episode = at least one criteria met for severe dengue (in accordance to the dengue with warning signs and severe dengue definitions in the 2009 WHO guidelines for dengue)."|From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject)|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who were defined as suspected dengue cases, excluding those without fever or reported before the first visit.|||Participants|||Count of Participants
2640976|NCT01751139|Secondary|Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Gender and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit|Incidence rate (IR) of primary inapparent dengue infection with 95% Confidence Interval (CI) by gender and, for each year separately and overall years calculated as the incidence rate per 1000 person-years, among subjects with no seroprevalence at the first visit: the numerator is the number of all primary inapparent dengue infection cases reported during the follow-up period at risk. The denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. The primary inapparent dengue infection condition was defined as a documented seroconversion (anti-dengue IgG antibodies) between two sequential sera samples obtained during the scheduled visits without clinical suspicion of dengue (identified during the time period in which seroconversion occurred). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons.|At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had no seroprevalence at first visit of the first year.|||infections per 1000 person-year||95% Confidence Interval|Number
2640977|NCT01751139|Secondary|Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Age Category and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit|Incidence rate (IR) of primary inapparent dengue infection with 95% Confidence Interval (CI) by age category and, for each year separately and overall years calculated as the incidence rate per 1000 person-years, among subjects with no seroprevalence at the first visit: the numerator is the number of all primary inapparent dengue infection cases reported during the follow-up period at risk. The denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. The primary inapparent dengue infection condition was defined as a documented seroconversion (anti-dengue IgG antibodies) between two sequential sera samples obtained during the scheduled visits without clinical suspicion of dengue (identified during the time period in which seroconversion occurred). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons.|At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had no seroprevalence at first visit of the first year.|||infections per 1000 person-year||95% Confidence Interval|Number
2640978|NCT01751139|Secondary|Incidence Rate (Per 1000 Person-years) of Primary Inapparent Dengue Infection by Study Site and Calendar Year, and Overall, Among Subjects With no Seroprevalence at the First Visit|Incidence rate (IR) of primary inapparent dengue infection with 95% Confidence Interval (CI) by site and, for each year separately and overall years calculated as the incidence rate per 1000 person-years, among subjects with no seroprevalence at the first visit: the numerator is the number of all primary inapparent dengue infection cases reported during the follow-up period at risk. The denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. The primary inapparent dengue infection condition was defined as a documented seroconversion (anti-dengue IgG antibodies) between two sequential sera samples obtained during the scheduled visits without clinical suspicion of dengue (identified during the time period in which seroconversion occurred). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons.|At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had no seroprevalence at first visit of the first year.|||infections per 1000 person-year||95% Confidence Interval|Number
2641167|NCT01748227|Secondary|Multidimensional Perceived Social Support Scale (MPSS).|12 items, possible range 12-84 with higher scores indicating higher social support (i.e., better outcomes).|Baseline and 4 month for Statistical Package for Social Scientists (SPSS) and only 4 month final interview for Working Alliance||||units on a scale||Standard Deviation|Mean
2640979|NCT01751139|Secondary|Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Age Group at Enrolment|A subject was considered as having previous dengue infection at baseline, based on seroprevalence at first visit, namely if Dengue IgG positive (i.e. reactive) at first visit or if Laboratory-confirmed symptomatic dengue case detected at first visit (baseline).|At the first visit of the first year|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year.|||Participants|||Count of Participants
2640980|NCT01751139|Secondary|Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Gender|A subject was considered as having previous dengue infection at baseline, based on seroprevalence at first visit, namely if Dengue IgG positive (i.e. reactive) at first visit or if Laboratory-confirmed symptomatic dengue case detected at first visit (baseline).|At the first visit of the first year|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year.|||Participants|||Count of Participants
2640981|NCT01751139|Secondary|Number of Subjects With Previous Dengue Infection (Dengue Seroprevalence) at Baseline, by Study Site and Overall|A subject was considered as having previous dengue infection at baseline, based on seroprevalence at first visit, namely if Dengue IgG positive (i.e. reactive) at first visit or if Laboratory-confirmed symptomatic dengue case detected at first visit (baseline).|At the first visit of the first year|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year.|||Participants|||Count of Participants
2640982|NCT01751139|Secondary|Number of Secondary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases|A secondary symptomatic dengue case is a subject with laboratory confirmed or probable symptomatic dengue infection, and with evidence of previous dengue infection (presence of IgG antibodies at the previous scheduled visit(s) or laboratory-confirmed symptomatic case detected previously at study surveillance). Analysis was not performed by DENV-type as data would not be reliable due to the low number of cases reported.|From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject)|Analysis was performed on the laboratory confirmed or probable symptomatic dengue cases, excluding those reported without fever or reported before the first visit in the first year.|||Participants|||Count of Participants
2640983|NCT01751139|Secondary|Number of Primary Symptomatic Dengue Infection Cases Among Laboratory-confirmed or Probable Cases|A primary symptomatic dengue case is a subject with laboratory confirmed or probable symptomatic dengue infection, and without evidence of previous dengue infection (absence of Ig G antibodies at the previous scheduled visit and absence of laboratory confirmed symptomatic case detected previously at study surveillance). Analysis was not performed by DENV-type as data would not be reliable due to the low number of cases reported.|From Year 2014 to Year 2018 (a range of 1 to 4 years for an individual subject)|Analysis was performed on the laboratory confirmed or probable symptomatic dengue cases, excluding those reported without fever or reported before the first visit in the first year.|||Participants|||Count of Participants
2640984|NCT01751139|Secondary|Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Gender, and Calendar Year|Incidence rate (IR) of laboratory-confirmed or probable symptomatic dengue infection with 95% Confidence Interval (CI) by gender, and for each year separately and overall years calculated as the incidence rate per 1000 person-years : the numerator is the number of all laboratory-confirmed or probable symptomatic dengue infection cases reported during the follow-up period at risk; the denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. For early presenters, a probable case was that case without laboratory confirmation, presenting IgG positive in the convalescent sample; for late presenters, a probable case was the case without seroconversion of IgM, presenting at least one IgG positive in one sample (acute or convalescent). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons.|At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year.|||infections per 1000 person-year||95% Confidence Interval|Number
2640985|NCT01751139|Secondary|Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Age Category, and Calendar Year|Incidence rate (IR) of laboratory-confirmed or probable symptomatic dengue infection with 95% Confidence Interval (CI) by age category, and for each year separately and overall years calculated as the incidence rate per 1000 person-years : the numerator is the number of all laboratory-confirmed or probable symptomatic dengue infection cases reported during the follow-up period at risk; the denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. For early presenters, a probable case was that case without laboratory confirmation, presenting IgG positive in the convalescent sample; for late presenters, a probable case was the case without seroconversion of IgM, presenting at least one IgG positive in one sample (acute or convalescent). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons.|At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year.|||infections per 1000 person-year||95% Confidence Interval|Number
2640994|NCT01751113|Secondary|Trough FEV1/FVC Ratio, at Each Clinic Visit Prior to the Morning Dose and Before the Use of Rescue Medication at Day 28 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration. FEV1 and FVC data was obtained by spirometry measurements. Trough values were the values taken pre-dose.|Day 28 of each treatment period (up to 35 days)|mITT Population|||Ratio of FEV1/FVC||Standard Error|Least Squares Mean
2641168|NCT01748227|Secondary|Pain Catastrophizing Scale|Pain Catastrophizing Scale. 13-item scale. Possible score range 0-52, with lower scores representing improvement.|Baseline and 4 month assessment (final assessment)||||units on a scale||Standard Deviation|Mean
2640986|NCT01751139|Secondary|Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed or Probable Symptomatic Dengue Infection by Study Site, and Calendar Year|Incidence rate (IR) of laboratory-confirmed or probable symptomatic dengue infection with 95% Confidence Interval (CI) by study site, and for each year separately and overall years calculated as the incidence rate per 1000 person-years : the numerator is the number of all laboratory-confirmed or probable symptomatic dengue infection cases reported during the follow-up period at risk; the denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. For early presenters, a probable case was that case without laboratory confirmation, presenting IgG positive in the convalescent sample; for late presenters, a probable case was the case without seroconversion of IgM, presenting at least one IgG positive in one sample (acute or convalescent). Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons.|At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year.|||infections per 1000 person-year||95% Confidence Interval|Number
2640987|NCT01751139|Secondary|Incidence Rate (Per 1000 Person-years) of All Virologically-confirmed Symptomatic Dengue Infection by Calendar Year|Incidence rate (IR) of virologically-confirmed symptomatic dengue infection with 95% Confidence Interval (CI) for each year separately and overall years calculated as the incidence rate per 1000 person-years : the numerator is the number of all virologically-confirmed dengue infection cases reported during the follow-up period at risk; the denominator is the total Person-years at risk, i.e. sum of the follow-up periods at risk expressed in years. A virologically confirmed symptomatic dengue infection is defined as a dengue case confirmed by RT-qPCR. Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons. Analysis was not performed by DENV-type as data would not be reliable due to the low number of cases reported.|At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year.|||infections per 1000 person-year||95% Confidence Interval|Number
2640988|NCT01751139|Primary|Incidence Rate (Per 1000 Person-years) of All Laboratory-confirmed Symptomatic Dengue Infection by Calendar Year|Incidence rate (IR) of laboratory-confirmed symptomatic dengue infection (lab-conf.) with 95% Confidence Interval (CI) for each year and overall, calculated as the incidence rate per 1000 person-years : numerator = number of all lab-conf. cases reported during the follow-up (FU) period at risk; denominator = total Person-years at risk, i.e. sum of FU periods at risk expressed in years until first Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) confirmed symptomatic dengue infection or subject's withdrawal, whichever came first. Lab-conf. case defined as follows: Dengue virus identification through RT-qPCR on acute serum sample or Dengue virus NS1 positive on acute serum sample through Enzyme-linked Immunosorbent Assay (ELISA) or Anti-Dengue Immunoglobulin type M (IgM) seroconversion between acute and convalescent serum samples through ELISA. Data were not analyzed by Dengue season as planned in the protocol as most of the cases occurred outside the seasons.|At each calendar year i.e. Year 2014, 2015, 2016, 2017, 2018, and overall calendar years|Analysis was performed on the According-to-Protocol cohort that included all evaluable subjects who met all eligibility criteria, complying with the procedures defined in the protocol and who had seroprevalence status at first visit of the first year.|||infections per 1000 person-year||95% Confidence Interval|Number
2640989|NCT01751113|Secondary|Use of Rescue Medication (Number of Occasions Per 24-hour Period) as Recorded in the Daily Record Card at Day 28 of Each Treatment Period|Participants were given daily record cards for daily completion during the run-in, washout and treatment periods. Each morning, participants recorded the number of occasions in the last 24 hours when they had used their rescue medication (salbutamol) for symptomatic relief of COPD symptoms.|Day 28 of each treatment period (up to 35 days)|mITT Population. Only those participants available who used rescue medication at the specified periods were analyzed (represented by n=X, X, X in the category titles).|||Number of occasions||Standard Deviation|Mean
2640990|NCT01751113|Secondary|Post-dose FEV1/FVC Ratio (Measured at Trough) at Day 28 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration. FEV1 and FVC data was obtained by spirometry measurements.|Day 28 of each treatment period (up to 35 days)|mITT Population|||Ratio of FEV1/FVC||Standard Error|Least Squares Mean
2640991|NCT01751113|Secondary|Post-dose FEV1, FVC, IC, RV, TLC and TGV (Measured at Trough) at Day 28 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration. FEV1 and FVC data was obtained by spirometry measurements. IC is defined as the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Total lung capacity (TLC) is the maximum volume to which the lungs can be expanded with the greatest possible inspiratory effort; it is equal to the vital capacity (VC) plus the RV. RV is defined as the volume of air remaining in the lungs after a maximal exhalation. Thoracic gas volume at functional residual capacity (TGV) is defined as the volume of intrathoracic gas at the time the airway is occluded for the plethysmographic measurement at the end of a normal expiration.|Day 28 of each treatment period (up to 35 days)|mITT Population|||Liters (L)||Standard Error|Least Squares Mean
2640992|NCT01751113|Secondary|Trough sGaw Measured at Each Clinic Visit Prior to the Morning Dose and Before the Use of Rescue Medication at Day 28 of Each Treatment Period|sGaw is a measure of airways conductance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Trough values were the values taken pre-dose.|Day 28 of each treatment period (up to 35 days)|mITT Population|||1/kPa*s||Standard Error|Geometric Mean
2640993|NCT01751113|Secondary|Trough sRaw Measured at Each Clinic Visit Prior to the Morning Dose and Before the Use of Rescue Medication at Day 28 of Each Treatment Period|sRaw is a measure of airways resistance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Trough values were the values taken pre-dose.|Day 28 of each treatment period (up to 35 days)|mITT Population|||kPa*s||Standard Error|Geometric Mean
2640995|NCT01751113|Secondary|Trough Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Inspiratory Capacity (IC), RV, TLC, and TGV at Each Clinic Visit Prior to the Morning Dose and Before the Use of Rescue Medication at Day 28 of Each Treatment Period|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can forcibly be blown out after a full inspiration. FEV1 and FVC data was obtained by spirometry measurements. IC is defined as the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Total lung capacity (TLC) is the maximum volume to which the lungs can be expanded with the greatest possible inspiratory effort; it is equal to the vital capacity (VC) plus the residual volume (RV). RV is defined as the volume of air remaining in the lungs. after a maximal exhalation. Thoracic gas volume at functional residual capacity (TGV) is defined as the volume of intrathoracic gas at the time the airway is occluded for the plethysmographic measurement at the end of a normal expiration. Trough values were the values taken pre-dose.|Day 28 of each treatment period (up to 35 days)|mITT Population|||Liters (L)||Standard Error|Least Squares Mean
2640996|NCT01751113|Secondary|Post-dose sRaw at 30, 75, 120 and 240 Minutes Post Dose at Day 28 of Each Treatment Period|sRaw is a measure of airways resistance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Plethysmography was performed to assess sRaw. A natural logarithmic transformation was applied and the data was analysed by a mixed model including treatment, time, period, a treatment by time interaction and Baseline sRaw fitted as fixed effects and participant fitted as a random effect.|Day 28 of each treatment period (up to 35 days)|mITT Population|||kPa*s||Standard Error|Geometric Mean
2640997|NCT01751113|Secondary|Post-dose sGaw at 30, 75, 120 and 240 Minutes Post Dose at Day 28 of Each Treatment Period|sGaw is a measure of airways conductance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Plethysmography was performed to assess sGaws. A natural logarithmic transformation was applied and the data was analyzed by a mixed model including treatment, time, period, a treatment by time interaction and Baseline sGaw fitted as fixed effects and participant fitted as a random effect.|Day 28 of each treatment period (up to 35 days)|mITT Population|||1/kPa*s||Standard Error|Geometric Mean
2640998|NCT01751113|Secondary|AUC (0-4hr) Specific Airway Resistance (sRaw) After the Morning Dose of Each Study Medication at Day 28 of Each Treatment Period|sRaw is a measure of airways resistance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Plethysmography was performed to assess sRaw. The AUC was determined by using the trapezoidal rule and then dividing by the relevant time interval. A natural logarithmic transformation was applied and the data was analyzed by a mixed model including treatment, period and Baseline sRaw fitted as fixed effects and participants fitted as a random effect. Treatment ratios of all statistical comparisons were calculated by taking the anti-log of the difference between the LS means.|Day 28 of each treatment period (up to 35 days)|mITT Population|||kPa*s||Standard Error|Geometric Mean
2640999|NCT01751113|Primary|Area Under the Curve Calculated From 0 to 4 Hours (AUC[0-4hr]) Specific Conductance (sGaw) After the Morning Dose of Study Medication at Day 28 of Each Treatment Period|sGaw is a measure of airways conductance and is intimately related to the diameter of the airways and consequently the level of bronchodilation. Plethysmography was performed to assess sGaw. The AUC was determined by using the trapezoidal rule and then dividing by the relevant time interval. A natural logarithmic transformation was applied and the data was analyzed by a mixed model including treatment, period and Baseline sGaw fitted as fixed effects and participants fitted as a random effect. Treatment ratios of all statistical comparisons were calculated by taking the anti-log of the difference between the Least Square (LS) means.|Day 28 of each treatment period (up to 35 days)|Modified Intent-to-Treat (mITT) Population: all randomized participants who received at least one dose of study medication and completed at least two treatment periods and also had a Baseline and at least one on treatment sGaw assessment measure.|||1/kilopascal*second (1/kPa*s)||Standard Error|Geometric Mean
2641000|NCT01751087|Secondary|Physician Satisfaction With Cervical Preparation|Participants for whom the operating physician reported being satisfied or very satisfied with the cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure.|physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes|"Data on whether the physician was satisfied with the cervical preparation is available for all participants except:~Arm 1: 1 participant withdrawn with no intervention; Arm 2: 1 participant who didn't have a D&E (expelled), Arm 3: 1 participant withdrawn with no intervention and one with missing data."|||participants||95% Confidence Interval|Number
2641001|NCT01751087|Secondary|Patient Satisfaction With Cervical Prep|Patients who were very satisfied or satisfied with cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure and just prior to discharge home.|patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days||||participants|||Number
2641002|NCT01751087|Secondary|Chills (Any) After Day 2 Medication Administration|chills (any) after Day 2 medication administration|assessed immediately after administration of day 2 medication||||participants||95% Confidence Interval|Number
2641003|NCT01751087|Secondary|Complications From Procedure|Patient having any complication, including hospitalizations transfusions additional unplanned procedures|assessed immediately after completion of D&E and at 1 week and 1 month post-procedure||||participants|||Number
2641004|NCT01751087|Secondary|Ease of Mechanical Dilation|Number of participants for whom, if additional mechanical dilation was required, it was difficult or very difficult. Assessed on day of procedure. Assessed after completion of D&E|participants were assessed for the duration of the procedure, an average of 6 minutes|Number of participants in each arm who required additional mechanical dilation|||participants|||Number
2641005|NCT01751087|Secondary|Need for Mechanical Dilation|Assessed on Day of procedure. Assessed immediately after completion of D&E|participants were assessed for the duration of the procedure, an average of 6 minutes|Arm 1: one subject withdrawn/no intervention. Arm 2: one subject expelled, no D&E. Arm 3: one subject withdrawn/no intervention|||participants||95% Confidence Interval|Number
2641006|NCT01751087|Secondary|Ability to Complete the D&E on the First Attempt|Assessed on day of procedure and following day. If the procedure was unable to be completed as planned and the subject had to leave the procedure room and return for another attempt either at a time later the same day or the next day.|participants were assessed for the duration of the procedure, an average of 6 minutes||||participants|||Number
2641007|NCT01751087|Secondary|Initial Cervical Dilation|Measured at the time of procedure (immediately before the start of D&E)|participants were assessed during cervical dilation process, average time of 1 minute|Arm 1: 1 subject excluded [withdrawn/no intervention]. Arm 2: 2 excluded: [one expelled, no D&E, one D&E not completed on first attempt & data missing]. Arm 3: 2 excluded (1 withdrawn/no intervention, 1 D&E not completed on first attempt & data missing]. Additionally missing data for one more subject in Arm 2.|||centimeters||Standard Deviation|Mean
2641008|NCT01751087|Primary|Operative Time|The duration of the D&E procedure was measured with a stopwatch, starting with the first instrument that passes into the uterus and ending when the last instrument is removed from the uterus upon completion of the D&E|participants were assessed for the duration of the procedure, an average of 6 minutes|Arm 1 (dilators-alone): 1 subject excluded [withdrawn/no intervention]. Arm 2 (dilators + misoprostol): 2 excluded: [one expelled, no D&E, one D&E not completed on first attempt & data missing]. Arm 3 (dilators + mifepristone): 2 excluded (1 withdrawn/no intervention, 1 D&E not completed on first attempt & data missing].|||minutes||Standard Deviation|Mean
2641009|NCT01751061|Secondary|Change in Clinical-surrogate Concordance Scale Score (Nurse)|"Concordance is calculated as the absolute value of the difference in prognosis for 1 year patient survival between the primary surrogate decision maker and the IUC nurse, and, therefore, can range from 0 to 100.~We report pre-intervention to post-intervention difference in the CSCS.~The CSCS is calculated as the absolute value of the difference between the surrogate's response and that of the nurse to the question, What percent chance do you think [the patient/your loved one] has of being alive 1 year from now if the current treatment plan is continued? Scores can range from 0 to 100 percentage points, and higher values indicate greater discordance."|~2-7 days post-randomization|nurses and primary surrogate decision makers|||units on a scale||95% Confidence Interval|Mean
2641010|NCT01751061|Secondary|Quality of Communication Scale Score|"Here we report QOC score differences between Interview 1 (baseline) and Interview 2 (immediately post-intervention) for primary (not secondary) surrogate decision makers.~Scores range from 0-110, with higher scores=better quality of communication."|Study day 1 (pre-randomization), ~2-7|Note that the discrepancy between the number of surrogates in these analyses (122 and 127) differs from those enrolled (137 and 138). This is because the QOC requires complete data at both Interview 1 and Interview 2. Some patients died or regained decisional capacity before Interview 2, leading to loss of surrogates' data.|||units on a scale||95% Confidence Interval|Mean
2641011|NCT01751061|Secondary|Medical Comprehension Scale Score|"Here we report MCS score differences between Interview 1 (baseline) and Interview 2 (immediately post-intervention) for primary (not secondary) surrogate decision makers.~Scores can range from 0-8, with greater scores=better comprehension."|Study day 1 (pre-randomization), ~2-7|Note that the discrepancy between the number of surrogates in these analyses (122 and 127) differs from those enrolled (137 and 138). This is because the MCS requires complete data at both Interview 1 and Interview 2. Some patients died or regained decisional capacity before Interview 2, leading to loss of surrogates' data.|||units on a scale||95% Confidence Interval|Mean
2641012|NCT01751061|Secondary|Patient-centeredness of Care Scale|"Here we report change in patient-centeredness score between Study day 1 (Interview 1) and 180 days post-randomization (Interview 4) for primary (not secondary) surrogate decision makers.~Scores can range from 12-48 points, with higher scores=greater patient-centeredness."|Study day 1 and 180 days post-randomization|Primary surrogate decision makers only; there is some dropout at 6 months due to patient death.|||units on a scale||95% Confidence Interval|Mean
2641013|NCT01751061|Secondary|Post-traumatic Stress Syndrome Inventory|"Here we report PTSS score differences between Interview 1 (baseline) and Interview 4 (6 months post-randomization) for primary (not secondary) surrogate decision makers.~PTSS scores can range from 10-70, with greater scores=more distress."|Pre-randomization (study day 1) and 180 days post-randomization|Primary surrogate decision makers only; there is some dropout at 6 months due to patient death.|||units on a scale||95% Confidence Interval|Mean
2641014|NCT01751061|Secondary|Hospital Anxiety and Depression Scale (HADS) Total Score|"We report here the difference between Interview 1 (baseline) and Interview 4 (6 months post-randomization) for primary surrogate decision makers (not secondary).~HADS scores can range from 0 to 42 points; higher scores=more distress."|Pre-randomization (study day 1) and 180 days post-randomization|Primary surrogate decision makers only. There is some dropout at 6 months due to patient death.|||units on a scale||95% Confidence Interval|Mean
2641015|NCT01751061|Primary|Change in Clinician-surrogate Concordance Scale Score|"Concordance is calculated as the absolute value of the difference in prognosis for 1 year patient survival between the surrogate(s) and the clinician (ICU physician), and, therefore, can range from 0 to 100.~We report pre-intervention to post-intervention difference in the CSCS.~The CSCS is calculated as the absolute value of the difference between the surrogate's response and that of either the treating ICU physician (primary outcome) or the nurse (secondary outcome) to the question, What percent chance do you think [the patient/your loved one] has of being alive 1 year from now if the current treatment plan is continued? Scores can range from 0 to 100 percentage points, and higher values indicate greater discordance."|~2-7 days post-randomization|Note that the discrepancy between the number of surrogates in these analyses (122 and 127) differs from those enrolled (137 and 138). This is because the CSCS requires complete data at both Interview 1 and Interview 2. Some patients died or regained decisional capacity before Interview 2, leading to loss of surrogates' data.|||score on a scale||95% Confidence Interval|Mean
2641016|NCT01751022|Secondary|Complication Rate for Individual Attain Performa Lead Related Events||6 month post-Implant|Subjects with Attain Performa LV Lead Model successfully implanted. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.|||percentage of participants||95% Confidence Interval|Number
2641017|NCT01751022|Secondary|Pacing Impedance at the Final Programmed Pacing Polarity|"Pacing impedance for each LV pacing polarity. Noticed that pacing impedance values are not recorded for reversed LV pacing polarities, since impedance from LV1 to LV2 is the same as from LV2 to LV1.~Impedance is a measurement of current/resistance between the pacing lead and the cardiac tissue (measured in Ohms)."|6 month post-implant|Subjects with Attain Performa LV lead implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit. Results for model 4298 comes from its PMA-S Clinical Report V1, 27MAR14; for model 4398 comes from its PMA-S Clinical Report V3, 03SEP14; for model 4598 comes from its PMA-S Clinical Report V1, 29AUG14.|||Ohms||Standard Deviation|Mean
2641018|NCT01751022|Secondary|Implant Related Times Per Attain Performa Lead Model||Implant up to 1-month post implant|Subjects with Attain Performa LV Lead Model successfully implanted. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.|||minutes||Standard Deviation|Mean
2641019|NCT01751022|Secondary|Pacing Capture Thresholds at the Final Programmed Pacing Polarity||6 months post-implant|Subjects with Attain Performa LV Lead Model implanted and valid pacing thresholds measured at the 6 month follow-up visit. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report V. 1, 29AUG2014.|||Volts||Standard Deviation|Mean
2641020|NCT01751022|Secondary|Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model||Implant up to 1-month post implant|Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.|||percentage of participants|||Number
2641021|NCT01751022|Secondary|Percentage of Subjects With Successful Implant Per Attain Performa Lead Model||Implant up to 1-month post implant|Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.|||percentage of participants||95% Confidence Interval|Number
2641022|NCT01751022|Secondary|Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities|Percentage of patients with presence of PNS in all LV lead pacing polarities at 8.0 V at 0.5ms performed at 6-month visit.|6 months post-implant|Subjects with Attain Performa LV Lead implanted and at least 1 valid pacing threshold at any LV lead pacing polarity measured at the 6 month visit. Results for model 4298 comes from its PMA-S Clinical Report V1, 27MAR14; for model 4398 comes from its PMA-S Clinical Report V3, 03SEP14; for model 4598 comes from its PMA-S Clinical Report V1, 29AUG14.|||percentage of participants|||Number
2641023|NCT01751022|Primary|LV Pacing Capture Thresholds Per Attain Performa Lead Model||6 months post-implant|Subjects with Attain Performa LV Lead Model implanted and valid pacing thresholds measured at the 6 month follow-up visit. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report V. 1, 29AUG2014.|||percentage of participants||97.5% Confidence Interval|Mean
2641024|NCT01751022|Primary|Lead Complication-free Rate at 6 Months|"The three Attain Performa LV leads models are evaluated separately. The primary safety objective is listed as following:~- Model 4298/4398: The Attain Performa Model 4298/4398 lead will be considered safe if the probability of subjects freed of Attain Performa lead-related complications at 6 months post-implant is greater than 87% (i.e., the one-sided 97.5% lower confidence bound must be greater than 87%).~- Model 4598: The safety performance of the Attain Performa Model 4598 lead will be characterized by summarizing the probability of subjects who are free from Attain Performa LV lead related complications at 6 months.~The lower boundaries of the 97.5% confidence intervals for the all lead models are greater than the pacing threshold of 87%, thus concluding that the crtiera was met for all lead models."|Implant to 6 months post-implant|Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.|||Survival Probability (%)||97.5% Confidence Interval|Number
2641025|NCT01750931|Secondary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, is medically important event or reaction, is associated with liver injury Alanine amino transferase (more than equal to [>=] 3 fold upper normal of limit [ULN]) or total bilirubin (>=2 fold ULN) or international normalization ratio more than 1.5. Refer to the general AE/SAE module for a list of AEs and SAEs.|Up to 20 days|All subject population.|||Participants|||Number
2641026|NCT01750931|Primary|Elimination Half Life (T-half) After a Single Dose|The T-half was calculated using the following formula by dividing 0.693 (natural logarithm of 2) with lambda z, where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data after each single dose.|Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period|All subject population. All participants were present at the time of measurement.|||Per hour||Full Range|Median
2641027|NCT01750931|Primary|Elimination Rate Constant (Kel) After a Single Dose|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The apparent first-order elimination or terminal rate constant was calculated from a semilogarithmic plot of the plasma concentration versus time. The parameter was calculated by linear least-square regression analysis using the last three (or more) non-zero plasma concentrations.|Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period|All subject population. All participants were present at the time of measurement.|||Per hour||Geometric Coefficient of Variation|Geometric Mean
2641085|NCT01749956|Secondary|The Number of Participants Who Experienced Serious or Non-Serious Adverse Events as a Measure of Safety.|Adverse events and serious adverse events (AEs and SAEs) were graded according to National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v4.0. Specific AE and SAE terms are provided in the Adverse Event module.|weekly for 6 weeks pre-op then every 2 weeks post-op, approximately 36 weeks|All patients who received at least one dose of protocol treatment.|||participants|||Number
2641028|NCT01750931|Primary|The Percentage of Area Under Curve Extrapolated to Arrive at AUC0-infinity (AUCpercentage [%]_Extrap [Residual Area]) After a Single Dose|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The percentage of area under curve extrapolated to arrive at AUC0-infinity (AUC%_Extrap [residual area]) was determined by AUC0-infinity minus AUC0-t divided by AUC0-infinity multiplied by 100.|Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period|All subject population. All participants were present at the time of measurement.|||Percentage of AUC Extrapolated||Geometric Coefficient of Variation|Geometric Mean
2641029|NCT01750931|Primary|The Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. AUC(0-t) was area under the plasma concentration-time curve from time of administration until the time of last quantifiable concentration. The area under the plasma concentration-time curve (AUC0-infinity), was estimated by linear trapezoidal rule and was sum of the AUC0-t and extrapolated to infinity by dividing the estimated last measurable plasma concentration by elimination rate constant lambda z. Where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data after each single dose. The AUC0-infinity was the sum of the estimated and extrapolated parts.|Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period|All subject population. All participants were present at the time of measurement.|||Nanogram.hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2641030|NCT01750931|Primary|Time to Maximum Concentration (T-max)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The Tmax was taken directly from the plasma concentration-time profile of individual participants. Plasma samples for PK analysis were drawn at indicated time points.|Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period|All subject population|||Hour||Full Range|Median
2641031|NCT01750931|Primary|Maximum Drug Concentration During the Selected Dosing Interval (Cmax) After a Single Dose|Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. The Cmax was taken directly from the plasma concentration-time profile of individual participants|Pre-dose (two samples collected within a period of 1 hour) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 12.0, 16.0, 24.0, 48.0, 72.0 and 96.0 hours post-dose in each treatment period|All subject population: all participants who complete all periods of the study. All participants were present at the time of measurement.|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2641032|NCT01750840|Secondary|Quality of Life Assessment|Quality of life was intended to be measured by 5 scoring systems that ask a range of questions about the patient's pain and function. No quality of life data was captured for any of the patients and as such no quality of life analysis was performed.|The quality of life assessment was to be completed at the regular doctor's visit at which the physician determined the patient to be healed. No quality of life data was collected.|No quality of life data was collected for any of the patients enrolled in the study. As such, no analysis was performed on quality of life measures.||||||
2641033|NCT01750840|Primary|Radiographic Assessment of Healing|Bone healing was assessed on x-rays and/or CT scan.|The time frame for healing determination was not pre-specified. Patients were evaluated at regular doctors' visits for up to 12 months. The physician determined the time point at which healing occurred for each patient at their regular visits.|All patients, with one nonunion fracture each, were treated with the Biomet EBI Bone Healing System. Four patients had final healing outcomes reported (two patients with a 5th metatarsal nonunion, one patient with a tibial nonunion and one patient with a fibula nonunion) and all healed in an average time of 2.5 months.|||percentage of healed fractures|Fractures||Number
2641034|NCT01750697|Secondary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Rituximab|Cmax is the maximum observed plasma rituximab concentration. Cmax was assessed at each visit following 1st, 2nd, 3rd, and 4th IV dose of rituximab 375 mg/m^2 on Days 1, 8, 15, and 22. Cmax was calculated in micrograms per millilitre (mcg/mL).|From Day 1 to Day 180|The PK analysis population included all participants in the safety population who provided at least one evaluable PK sample.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2641035|NCT01750697|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve From Time 0 to 180 Days (AUC-180) of Rituximab|The AUC0-180 is a measure of the plasma concentration of rituximab over time. The AUC0-180 was calculated in micrograms per millilitres times day (mcg/mL*day).|From Day 1 to Day 180|The PK analysis population included all participants in the safety population who provided at least one evaluable PK sample.|||mcg/mL*day||Geometric Coefficient of Variation|Geometric Mean
2641036|NCT01750697|Primary|Pharmacokinetics: Volume of Distribution (Vd) of Rituximab|Vd is defined as the theoretical central volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vd was calculated in millilitres (mL).|From Day 1 to Day 180|The PK analysis population included all participants in the safety population who provided at least one evaluable PK sample.|||mL||Geometric Coefficient of Variation|Geometric Mean
2641037|NCT01750697|Primary|Pharmacokinetics: Rituximab Clearance (CL)|"CL is a quantitative measure of the rate at which a drug substance is removed from the body. The following allometric scaling equation was used for the estimation of CL in children:~CL= qCL X (BSA/1.9) 0.92 X 1.31*ADA~where qCL is a typical value of clearance in millilitres per day (mL/day) for a typical participant (i.e., Body Surface Area (BSA) of 1.9 m^2 and absence of anti-rituximab antibodies (ADA)) and is equal to 258 mL/day; BSA is in m^2 and ADA is 1 when anti-rituximab antibodies are present (0 otherwise). The allometric scaling factor was 0.92. CL was calculated in millilitres per day (mL/day)."|From Day 1 to Day 180|The PK analysis population included all participants in the safety population who provided at least one evaluable PK sample.|||mL/day||Geometric Coefficient of Variation|Geometric Mean
2641086|NCT01749956|Secondary|Disease Free Survival Probability at 6 and 12 Months|The probability of disease free survival at 6 and 12 months after initiating protocol treatment.|Up to 1 year||||probability||95% Confidence Interval|Number
2641038|NCT01750697|Primary|Percentage of Participants With Adverse Events (AEs), Including Serious AEs|An AE is any unfavourable and unintended sign (including abnormal laboratory finding), symptom, or disease temporarily associated with the use of a study drug, whether or not considered related to the study drug. A SAE is any experience that results in death, is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant.|Baseline (Day 1) up to last visit (1.5-5 years)|The safety population included all participants who received at least part of one infusion of rituximab.|||percentage of participants|||Number
2641039|NCT01750684|Secondary|Pharmacokinetic (PK) Parameters of AC105 Using Individual Patient Plasma Concentration-time Data|Measuring Maximum Measured Plasma Concentration (Cmax), Time to Maximum Measured Plasma Concentration (Tmax), Half-life calculated as In(2)/kel (T 1/2) and Area Under the Plasma Concentration versus time curve (AUC).|baseline, prior to and up to 5 hours following last infusion|No subjects were analyzed. No data was collected. There was a change in the planned analysis to not perform formal PK analysis for a terminated study and abbreviated Clinical Study Report.||||||
2641040|NCT01750684|Primary|Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0|Treatment-Emergent Adverse Events (TEAEs) are defined as AEs with date time of onset (or worsening) on or after the start date time of the first infusion and no more than 30 days after the end of the last infusion.|up to 6 months|Safety Population|||participants|||Number
2641041|NCT01750502|Other Pre-specified|Comparison of MIF-173G/C Alleles of CHD Patients and Controls.||Before surgery|All participants drawn from hospital inpatient cardiovascular medicine between June 2012-January 2013.This analysis was per protocol, but not intention to treat.Because the number of CHD group is less than the normal group during hospitalization.|||alleles|||Number
2641042|NCT01750502|Other Pre-specified|Comparison With MIF-173G/C Genotypes of CHD Patients and Controls.||Before surgery||||participants|||Number
2641043|NCT01750502|Secondary|Comparison the Change of MIF Before and After Percutaneous Coronary Intervention （PCI） at the Patients Who Are Acute Coronary Syndromes and Stable Ischemic Heart Disease|Percutaneous Coronary Intervention are extracted 3 times including before surgery 5 minutes , 5 minutes after the opening of the balloon and after surgery 5 minutes ,and detection MIF concentration .|3 times including before surgery 5 minutes, 5 minutes after the opening of the balloon and after surgery 5 minutes|Coronary-artery-disease Group does not include myocardial infarction, 21 patients were acute myocardial infarction participants.|||MIF Concentration , ug/L||Standard Deviation|Mean
2641044|NCT01750502|Primary|Comparison Between Coronary-artery-disease Group and Non-coronary-artery-disease Group on MIF Concentration|Participants will be extracted 3ml blood before surgery 5 minutes,detection MIF concentration on two groups.We hypothesis that the experimental group will be higher than control group.|Before surgery 5 minutes|All participants drawn from hospital inpatient cardiovascular medicine between June 2012-January 2013.This analysis was per protocol, but not intention to treat.Because the number of CHD group is less than the normal group during hospitalization.|||MIF Concentration,ug/L||Standard Deviation|Median
2641045|NCT01750398|Secondary|Change in Waist Circumference||Bseline, 6 months and 9 months.||||cm||Standard Deviation|Mean
2641046|NCT01750398|Secondary|Change in Weight|Change in weight is measured from baseline to 6 months (i.e. following ADT lead in) and from 6 months to 9 months (i.e. from post-ADT to the end of cycle 1 of BAT).|Baseline, 6 months and 9 months.||||kg||Standard Deviation|Mean
2641047|NCT01750398|Secondary|Quality of Life Survey|"To measure quality of life through the RAND-SF36 (short-form 36 questionnaire) Quality of Life Survey, the Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P), the International Index of Erectile Function (IIEF), the International Prostate Symptom Score (IPSS) and a visual pain scale. Note that for all scales, higher scores indicate better quality of life/function, with the exception being the visual pain scale, where a higher score indicates more pain.~RAND-SF36: SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. Range is from 0 to 100.~FACT-P: A tool used for assessing the health-related quality of life in men with prostate cancer. Range is from 0 to 156.~IIEF: Is a measure of erectile function. Range is from 5 to 25. IPSS: A tool used to measure symptoms related to prostatic disease. Range is from 0 to 35.~Visual pain scale: A tool used to track pain level. Range is from 0 to 10."|3 months||||units on a scale||Full Range|Median
2641048|NCT01750398|Secondary|Change in C-telopeptides|Change in c-telopeptides following Round 1 of BAT (9 months) compared to the timepoint immediately following the ADT Lead-In (6 months)|6 months and 9 months||||pg/ml||Standard Deviation|Mean
2641049|NCT01750398|Secondary|Complete PSA Response|To evaluate the number of patients who achieve a complete PSA response (i.e. serum PSA <0.2 ng/ml) at the end of the study|18 months||||participants|||Number
2641050|NCT01750398|Secondary|Radiographic or Clinical Progression|To evaluate the number of men treated per the bipolar androgen therapy phase of the trial who developed radiographic or clinical progression. Radiographic progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Clinical progression was defined as new symptoms that can be attributed to progressive prostate cancer (e.g. new/worsening pain, urinary obstruction, cord compression, bone fractures).|18 months||||participants|||Number
2641051|NCT01750398|Primary|Patients With PSA <4 ng/mL at the End of the Study|To determine the clinical effects of BAT in men with recurrent prostate cancer as first line therapy. This will be accomplished by assessing the number of patients achieving a PSA <4 ng/ml at the end of the trial.|18 months||||participants||90% Confidence Interval|Number
2641052|NCT01750346|Secondary|The Jankovic Blepharospasm Rating Scale at 7 Months|"The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 7 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|7 months||||units on a scale|||Number
2641053|NCT01750346|Secondary|The Jankovic Blepharospasm Rating Scale at 6 Months|"The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 6 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|6 months||||units on a scale|||Number
2641054|NCT01750346|Secondary|The Jankovic Blepharospasm Rating Scale at 3 Months|"The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 3 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|3 months||||units on a scale||Full Range|Mean
2641055|NCT01750346|Secondary|The Blepharospasm Disability Scale at 2 Months|The Blepharospasm Disability Scale (BDS) was measured at 2 months from the start of the study drug or placebo. The BDS is a scale which measures the impact of blepharospasm on the activities of daily living, i.e., need to wear sunglasses (1 or 2) and the impact on the following activities: driving (1 to 5), reading (1 to 3), watching tv (1 to 3), watching movies (1 to 3), shopping (1 to 3), walking about (1 to 4) and housework or job (1 to 3). Patients self-report disability in all areas for a total score between 0 to 26, where 0 indicates no symptoms and 26 indicates severe disability.|2 months||||units on a scale||Full Range|Mean
2641056|NCT01750346|Secondary|The Blepharospasm Disability Scale at 1 Month|The Blepharospasm Disability Scale (BDS) was measured at 1 month from the start of the study drug or placebo. The BDS is a scale which measures the impact of blepharospasm on the activities of daily living, i.e., need to wear sunglasses (1 or 2) and the impact on the following activities: driving (1 to 5), reading (1 to 3), watching tv (1 to 3), watching movies (1 to 3), shopping (1 to 3), walking about (1 to 4) and housework or job (1 to 3). Patients self-report disability in all areas for a total score between 0 to 26, where 0 indicates no symptoms and 26 indicates severe disability.|1 month||||units on a scale||Full Range|Mean
2641057|NCT01750346|Secondary|The Jankovic Blepharospasm Rating Scale at 1 Month|"The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 1 month from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|1 month||||units on a scale||Full Range|Mean
2641058|NCT01750346|Primary|The Jankovic Blepharospasm Rating Scale at 2 Month|"The Jankovic Blepharospasm Rating Scale (JBRS) at 2 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally blind due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8."|2 months|One participant in the 0.05% AH-8 arm was withdrawn due to development of blepharitis.|||units on a scale||Full Range|Mean
2641059|NCT01750294|Primary|Change of Systolic Ambulatory Blood Pressure From Baseline to 12 Weeks||Baseline and 12 weeks after intervention|Intention to treat analysis (includes completers and non-completers)|||mmHg||Standard Deviation|Mean
2641060|NCT01750281|Secondary|Overall Survival (OS)|The time from randomisation until death due to any cause. Any subject not known to have died at the time of analysis will be censored based on the last recorded date on which the subject was known to be alive|Following progression, survival status was collected every 8 weeks until death, withdrawal of consent, or end of study, whichever occurred first, up to 29 months (at the time of the analysis)|Full Analysis Set (All randomised patients)|||Months||Inter-Quartile Range|Median
2641061|NCT01750281|Primary|Progression Free Survival (PFS)|Median time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression). Progression is defined using Response Evaluation Criteria in Solid Tumours (RECIST v1.1): >= 20% increase in the sum of diameters of Target Lesions (TL) and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of Non TLs or a new lesion.|Baseline and then every 6 weeks after randomization until objective disease progression, up to 29 months (at the time of the analysis)|Full Analysis Set (All randomised patients). Progression events that do not occur within 14 weeks of the last evaluable assessement are censored and therefore excluded.|||Months||Inter-Quartile Range|Median
2641062|NCT01750255|Secondary|Preventable Causes of Problems of Effectiveness and Safety of Pharmacotherapy|Quantify the preventable causes of problems of effectiveness and safety of pharmacotherapy. Quantify the process problems like a drug availability problems, problems in prescribing, dispensing problems, administration and use, quality problem.[Time Frame: At 3, 6, 9 and 12 months]|1 year|||||||
2641063|NCT01750255|Secondary|Necessity, Effectiveness and Security Problems Associated With Pharmacotherapy|Necessity problems of pharmacotherapy are related to the following two questions: 1) The patient has a health problem associated with not receiving a medication you need? 2) The patient has a health problem associated with getting a medicine that does not need. The safety of the pharmacotherapy will be measured by the safety profile of drugs and serum concentrations of drugs. The effectiveness of the pharmacotherapy will be measured by Hamilton Rating Scale for Depression, Clinical Global Impressions (CGI), Young Mania Rating Scale.|1 year|||||||
2641064|NCT01750255|Secondary|Depression|To assess depressive symptoms, will be used the the Hamilton Depression Rating Scale. [Time Frame: At 3, 6, 9 and 12 months]using hamilton depression scale|1 year|||||||
2641065|NCT01750255|Secondary|Mania||1 year|||||||
2641066|NCT01750255|Secondary|Clinical Global Impression for Bipolar Modified, CGI-BP-M.|The modified version of the Clinical Global Impression for Bipolar Disorder (CGI-BP-M) a condensed version of the CGI-BP, which is also an adaptation of the CGI for bipolar patients. The CGI-BP-M, is a scale for the assessment of manic, hypomanic, depressive or mixed symptoms, and long-term outcome of bipolar disorder. Assesses the current gravity, the short and long term of the disease course. It consists of three subscales, composed of a single item, evaluating the severity of the acute symptoms of depression, mania and disease in general (refers to the longitudinal disease severity). It has a Likert intensity scale of 7 degrees of freedom ( 1 normal, 7 very severe).|1 year||||Clinical Global Impression||Standard Deviation|Mean
2641067|NCT01750255|Secondary|Adherence to Treatment|Total percentage of adherence by treatment group|1 year|Total percentage of adherence by treatment group|||Medication adherence percentage|||Number
2641068|NCT01750255|Secondary|Quality of Life|The Short Form-36 Health Survey (SF-36): It is a questionnaire to measure quality of life, exploring the physical and mental health. Contains 36 topics that explore 8 dimensions of health: physical function; social function; limitations of the role: physical problems; limitations of the role: emotional problems; mental health; vitality; pain and general health perception. Each of the 8 dimensions of the SF-36 scores range between 0 and 100 values. 100 being a result indicating optimal health and 0 would reflect in a very bad state of health. The questionnaire allows the calculation of 2 scores summary, physical component summary (PCS) and mental (MCS), by combining each dimension scores|1 year||||Mental health summary score||Standard Deviation|Mean
2641069|NCT01750255|Primary|To Reduce the Use of Health Care Services by Quantifying the Number of Unscheduled Outpatient Visits||1 year||||Outpatient-unscheduled visits|||Number
2641070|NCT01750255|Primary|To Reduce the Use of Health Care Services by Quantifying the Number of Emergency Service Consultations||1 year||||Emergency Service Consultations|||Number
2641071|NCT01750255|Primary|To Reduce the Use of Health Care Services by Quantifying the Number of Hospitalizations||1 year||||Hospitalizations|||Number
2641072|NCT01750242|Secondary|Additional Study Measure on Unified Parkinson's Disease Rating Scale (UPDRS) III Scores|The summary of UPDRS III medication off score at baseline and the UPDRS III stimulation on/medication off score at follow-up and the change from baseline to 18 months. The UPRS III has a range of 0 - 108.|Change from baseline to 18 months|Per protocol|||units on a scale||Standard Deviation|Mean
2641073|NCT01750242|Primary|To Characterize the Percentage of Leads in Which the Target Map and the Clinically-derived Activation Map Overlap|The one-sided 95% exact binomial lower confidence bound of the proportion was calculated from subjects with readable images enrolled in the study.|18 months|Per Protocol|||percentage of leads|Participants||Number
2641074|NCT01750229|Primary|Visual Analog Scale (VAS) on Back Pain|Visual Analog Scale (VAS) back pain scores were recorded once a day on a multi-day diary, where subjects rate the pain by making a vertical slash mark through the 0-10cm line that best describes their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS back pain score represented worse back pain. The average VAS back pain scores from the last three days of diary prior to the follow-up visits were used for analysis.|12 weeks|Per-protocol population, subjects who followed the protocol and provided data for all four randomized crossover period were included in the analysis.|||units on a scale||Standard Deviation|Mean
2641075|NCT01750086|Primary|Bone Turnover Marker (Blood Sample)|The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8.|8 weeks||||percentage of change in CTX||Standard Deviation|Mean
2641076|NCT01749995|Secondary|To Develop a Tumour Tissue Database (Bio Bank) of Elderly Cancer Patients, Solely for Scientific Purposes||Baseline|||||||
2641077|NCT01749995|Secondary|To Compare the Freund Scoring System With Other Scoring Systems (Such as Watson and Colleagues), When Using a Predrawn Circle||Baseline|||||||
2641078|NCT01749995|Secondary|To Determine the Time-saving|Determination of the time-saving when using the Freund Clock Drawing Test instead of the Folstein MMSE|Baseline|||||||
2641079|NCT01749995|Secondary|Evaluation of the Mini-Cog (Cognitive Screening Tool Consisting of a Clock Drawing With 3-word Recall Test) When Using the Freund CDT||Baseline|||||||
2641080|NCT01749995|Primary|Further Registration of Data in a Database Coupled to the Cancer Registry in the General Hospital Groeninge as Set up by the PROGERCAN Study|During the PROGERCAN study, a database was set up in which the results of the CGA were coupled to the data available in the Cancer Registry of the General Hospital Groeninge. In this project, we aim continue this registration.|Baseline|||||||
2641081|NCT01749995|Primary|Validation of the Freund Clock Drawing Test, and Its Predefined Cut-off of ≤ 4, as a Screening Tool to Identify Elderly Cancer Patients in Need of a More In-depth Cognitive Evaluation With the Folstein MMSE Within Comprehensive Geriatric Assessment|A Receiver Operating Characteristic (ROC) analysis was applied in order to validate the Freund Clock Drawing Test at its predefined cut-off of ≤ 4. This ROC analysis illustrates the capacity of the Freund Clock Drawing Test to identify elderly cancer patients in need of a more in-depth cognitive evaluation with the Folstein MMSE within comprehensive geriatric assessment. The ROC curve is a fundamental tool for diagnostic test evaluation. In a ROC curve the true positive rate (Sensitivity) is plotted in function of the false positive rate (100-Specificity) for different cut-off points of a parameter. The AUC (Area Under Curve) is the area enclosed by the ROC curve. The range of possible AUC values is [0, 1]. A perfect classifier has AUC = 1 and a completely random classifier has AUC = 0.5. Usually, themodel will score somewhere in between.|Baseline||||unitless||95% Confidence Interval|Number
2641082|NCT01749982|Primary|Change in Urinary % Dimethyl Arsenic||From baseline to 8 weeks after the start of the intervention (week 8 - baseline)||||percentage of total urinary arsenic||Full Range|Median
2641083|NCT01749982|Primary|Change in Urinary % Inorganic Arsenic||From baseline to 8 weeks after the start of the intervention (week 8 - baseline)||||percentage of total urinary arsenic||Full Range|Median
2641084|NCT01749982|Primary|Change in Urinary % Monomethyl Arsenic||From baseline to 8 weeks after the start of the intervention (week 8 - baseline)||||percentage of total urinary arsenic||Full Range|Median
2641087|NCT01749956|Secondary|Disease-Free Survival||Patients without evidence of progression will be followed every 3 months (±1 month) from date of last dose of study drug during Years 1-2, every 6 months during Years 3-4, and annually thereafter or until disease progression, estimated 5 years.|All evaluable patients.|||percentage of participants||95% Confidence Interval|Median
2641091|NCT01749956|Primary|Pathologic Complete Response Rate|The Pathologic Complete Response (pCR) Rate is defined as the number of pathologic complete responders among all patients evaluable for response, including evaluable patients who did not proceed to surgery. A pCR is defined as the absence of any residual abnormality detected in a pathological specimen.|Between days 57 and 98 after preoperative chemotherapy|All patients enrolled in the trial who were evaluable for pathologic response. Four patients were not evaluable for response.|||participants|||Number
2641092|NCT01749930|Other Pre-specified|Number of Participants With Ocular and Systemic Adverse Events|Following assessments through 3 months (Visit 6), all participants, irrespective of previous randomization, converted to a single open label safety arm receiving BOL-303259-X QD in the evening for an additional 3 months through Visit 7. Adverse events were recorded throughout the comparative efficacy phase and open label extension phase.|6 months|Safety population. Of the subjects randomized, 415 instilled at least one dose of study medication and were included in the safety population|||Participants|||Count of Participants
2641093|NCT01749930|Secondary|IOP Reduction ≥ 25%|Percentage of participants with IOP reduction ≥ 25% consistently at all 9 time points in the first 3 months|8 AM, 12 PM, and 4 PM at Visit 4 (Week 2), Visit 5 (Week 6), and Visit 6 (Month 3)|Intent-to-treat population with LOCF|||Participants|||Count of Participants
2641094|NCT01749930|Secondary|IOP ≤ 18 mm Hg|Percentage of participants with IOP ≤ 18 mm Hg consistently at all 9 time points in the first 3 months|8 AM, 12 PM, and 4 PM at Visit 4 (Week 2), Visit 5 (Week 6), and Visit 6 (Month 3)|Intent-to treat population with LOCF|||Participants|||Count of Participants
2641095|NCT01749930|Primary|Mean IOP|Mean intraocular pressure (IOP) in the study eye measured at the specified time points: 8 AM, 12 PM, and 4 PM at Visit 4 (Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).|8 AM, 12 PM, and 4 PM at Visit 4 (Week 2), Visit 5 (Week 6), and Visit 6 (Month 3)|Intent-to-treat population with LOCF|||mm Hg||Standard Deviation|Least Squares Mean
2641096|NCT01749904|Other Pre-specified|Number of Participants With Ocular and Systemic Adverse Events|Following assessments through Visit 6 (Month 3), all participants, irrespective of previous randomization, converted to a single open label safety arm receiving BOL-303259-X QD in the evening. Adverse events were recorded throughout the comparative efficacy phase and open label extension phase.|12 months|Safety population (analyzed as treated). Of the 420 subjects randomized, 418 instilled at least one dose of study medication and were included in the safety population; one subject randomized to BOL-303259-X received timolol in the efficacy phase and was therefore analyzed as part of the timolol treatment group.|||Participants|||Count of Participants
2641097|NCT01749904|Secondary|Response Rate - IOP Reduction ≥ 25%|Percentage of participants with IOP reduction ≥ 25% consistently at all 9 time points in the first 3 months|8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).|Intent-to-treat with LOCF|||Participants|||Count of Participants
2641098|NCT01749904|Secondary|Response Rate - IOP ≤ 18 mm Hg|Percentage of participants with IOP ≤ 18 mm Hg consistently at all 9 time points in the first 3 months|8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).|Intent-to-treat population with LOCF|||Participants|||Count of Participants
2641099|NCT01749904|Primary|Mean IOP|Mean intraocular pressure (IOP) in study eye measured at the specified time points: 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).|8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3)|Intent-to-treat population with LOCF|||mm Hg||Standard Deviation|Least Squares Mean
2641100|NCT01749826|Secondary|Mechanical Pain Stimuli|"Pain sensitivity will be tested with three different mechanical stimuli that can elicit mild pain:~Stroking stimulus: skin will be tested with a brush that is moved three times across the lesion~Punctuated stimulus: a metal rod (1/100 of an inch in diameter) mounted onto 10 different weights (0.03-2.9 ounces) will repetitively be placed onto the skin~Blunt stimulus: a flat probe (0.4 inch in diameter) will be placed five times onto the patient's skin"|Changes in mechanical pain stimuli will be assessed between measurements taken on Day 1 and Day 30|Data can not be summarized or included in this table as no data on this measure was collected. Mechanical pain stimuli data was not collected from any participants at any point in time during the study as the study was terminated due to a lack of resources prior to collection of any study measure data.||||||
2641101|NCT01749826|Secondary|Peltier Device-Heat Pain|A hand-held 0.6x0.6 inch metal probe will be brought into contact with the patient's skin. Starting at 95 F, the probe temperature will increase at a rate of 1.8 F per second. The patient will be asked to push a button of a hand-held device as soon as the patient feels pain.|Differences in heat pain are assessed between measurements taken on Day 1 and Day 30|Data can not be summarized or included in this table as no data on this measure was collected. Peltier device-heat pain data was not collected from any participants at any point in time during the study as the study was terminated due to a lack of resources prior to collection of any study measure data.||||||
2641102|NCT01749826|Secondary|Laser Doppler Images|The laser doppler is a noninvasive, painless measurement of superficial perfusion that reflects inflammation. Laser doppler images will be taken once per study visit.|Changes in laser doppler images are measured between images taken on Day 1 and Day 30|Data can not be summarized or included in this table as no data on this measure was collected. Laser doppler image data was not collected from any participants at any point in time during the study as the study was terminated due to a lack of resources prior to collection of any study measure data.||||||
2641103|NCT01749826|Primary|Changes in Cytokine Release|5 CCs of blood are drawn on day 1 and day 30.|Changes in cytokine release are compared between blood samples drawn on Day 1 and Day 30|Data can not be summarized or included in this table as no data on this measure was collected. 5 CCs of blood were not drawn from any participants at any point in time during the study as the study was terminated due to a lack of resources prior to collection of any study measure data.||||||
2641104|NCT01749800|Primary|Sustained Attention to Response Task|Subjects are presented with objects (one at the time) on a computer screen and are instructed to press a key on the keyboard according to the characteristics of the object shown on the computer screen. Error rates are measured as percentage of erroneous key selections.|Baseline and end-of-treatment data (up to 2 weeks)||||percentage errors||Full Range|Mean
2641169|NCT01748227|Primary|Pain/Enjoyment of Life/General Activity|3-item version of the Brief Pain Inventory. Possible range: 0-30. 0=no pain/interference, 30=maximum pain/interference. Thus lower values represent a better outcome.|Change from baseline to 4 month assessment||||units on a scale||Standard Deviation|Mean
2641105|NCT01749735|Primary|Change in Box and Block Test Score From Baseline|"The Box and Block Test is a functional test. Subjects are instructed to move small blocks from one box to a second box. The test measures the number of blocks that subjects can move during a period of 60 sec. The measurement unit for this task is the number of blocks. Subjects with no motor impairments would typically move about 60 to 80 blocks in a period of 60 sec."|Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post||||number of blocks||Standard Deviation|Mean
2641106|NCT01749735|Primary|Change in Jebsen-Taylor Hand Function Test Score From Baseline|The Jebsen-Taylor Hand Function Test is a functional test consisting of 7 subtests. Each subtest requires that the subject performs a motor task (e.g. using one hand to pick up a small object positioned on a table in front of the subject). The test score is derived by measuring (using a stopwatch) the time in sec that the subject needs to complete the task. Individuals with no motor impairments typically need between 30 and 60 sec to complete the 7 subtests of the Jebsen-Taylor Hand Function Test.|Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post||||seconds||Standard Deviation|Mean
2641107|NCT01749631|Secondary|Mean Number of Intubation Attempts||Start of intubation to completion of intubation (up to 15 minutes)|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.|||number of attempts||Standard Error|Mean
2641108|NCT01749631|Secondary|Percentage of Participants Who Experienced Difficulties Related to the Use of Sevoflurane|The percentage of participants who experienced difficulties related to the use of sevoflurane including, but not limited to, vocal cords adduction, coughing, movements, and apnea episodes.|From start of induction to completion of intubation (up to 30 minutes)|ITT population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery.|||percentage of participants|||Number
2641109|NCT01749631|Secondary|Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure|The percentage of participants who experienced complications resulting from the intubation procedure including, but not limited to, bleeding, salivating, and lung aspiration.|Start of intubation to completion of intubation (up to 15 minutes)|ITT population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery.|||percentage of participants|||Number
2641110|NCT01749631|Secondary|Mean Duration of Intubation Procedure (in Minutes)|The mean duration of intubation procedure (in minutes) was defined as the time from intubation start to the completion of the intubation process (from tube introduction to partial pressure of end-tidal carbon dioxide [PETCO2]).|Start of intubation to completion of intubation (up to 15 minutes)|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.|||minutes||Standard Error|Mean
2641111|NCT01749631|Secondary|Percentage of Participants With Mallampati Score III and IV|Mallampati classification correlates tongue size to pharyngeal size. The test is performed with the patient in the sitting position, head in a neutral position, the mouth wide open and the tongue protruding to its maximum, without phonation. Classification is assigned according to the extent the base of tongue is able to mask the visibility of pharyngeal structures: Class I = visualization of the soft palate, fauces; uvula, anterior and the posterior pillars; Class II = visualization of the soft palate, fauces and uvula; Class III = visualization of soft palate and base of uvula; and Class IV: only hard palate is visible, soft palate is not visible at all. A high score (Class III or IV) is associated with more difficult intubation.|Screening|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.|||percentage of participants|||Number
2641112|NCT01749631|Secondary|Mean Duration of Induction (in Seconds)|The mean duration of induction (in seconds) was defined as the time required to reach a Ramsay Sedation Score (RSS) of 5 from start of induction. The RSS levels are defined as 1 = anxious, agitated or restless; 2 = calm, co-operative and communicative; 3 = response is quick to a voice command; 4 = response is slow to a voice command; 5 = slow or sluggish response; and 6 = no response at all.|From start of induction up to 15 minutes|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.|||seconds||Standard Error|Mean
2641113|NCT01749631|Primary|Percentage of Participants With Successful Intubation (Clinical Success)|Participants were considered to have a successful intubation if intubation was achieved in less than 4 separate intubation attempts according to the guidelines of the American Society of Anesthesiologists (ASA). The number of intubation attempts was a maximum of 3 attempts, after which the intubation was considered a failure.|Start of intubation to completion of intubation (up to 15 minutes)|Per protocol population: all participants prescribed sevoflurane due to an anticipated difficulty in intubation during surgery and who met the study’s inclusion/exclusion criteria.|||percentage of participants|||Number
2641114|NCT01749605|Primary|Number of Participants With Clinical Cure at Day 7|Seven days after randomization, subjects received a telephone call to determine if their symptoms have completely resolved. Patients answers were limited to: Yes (clinical cure), No (treatment failure)|7 days||||participants|||Number
2641115|NCT01749501|Secondary|Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded.||24 hours after intubation procedure||||minutes||Standard Deviation|Mean
2641116|NCT01749501|Primary|Present the Percentage of Participants With an Excellent Ease of Intubation Rating|"percentage of participants with an excellent ease of intubation rating based on Scale of 1-4 (1 Being Excellent, 4 Being Poor),"|24 hours after intubation period||||% reported as excellent|||Number
2641117|NCT01749410|Primary|Change From Baseline in the Number of Headache Days|The mean number of headache days was counted as the number of headache days occurring during the 30 day period ending with treatment cycle 7. Each treatment cycle was administered approximately every 12 weeks.|Treatment Cycle 7 (approximately 1.5 years)|All subjects who satisfied the inclusion and exclusion criteria|||Days||Standard Deviation|Mean
2641118|NCT01749293|Secondary|Number of Participants That Had an Event Free Survival Rate|To estimate the number of participants who had an event free survival rate|Up to 1 year post-transplant||||Participants|||Count of Participants
2641119|NCT01749293|Secondary|Number of Participants That Had an Overall Survival Rate|To estimate the number of participants that had an overall survival (OS) rate|Up to one year post-transplant.||||Participants|||Count of Participants
2641120|NCT01749293|Primary|Number of Participants That Engrafted and the Number of Participants That Had Full Donor Chimerism at Day 60|To estimate the number of participants that had engraftment rates and the number of participants that had full donor chimerism at Day 60 in patients undergoing an HLA haploidentical stem cell transplant with post transplant high dose cyclophosphamide.|Up to Day 60 post-transplant.||||Participants|||Count of Participants
2641121|NCT01749033|Secondary|Blood on LMA After Removal|Presence of blood immediately after the removal of the LMA after surgery.|Immediately after LMA removal||||Participants|||Count of Participants
2641122|NCT01749033|Secondary|Severity of Sore Throat|"Severity of sore throat 24 hours after airway placement on a 11 point scale of 0-10 ( 0 equals no pain and 10 equals worst pain ever) per recovery hour.~Low pain = 0 high pain= 500 composite score (0 to 11 points per hour x 24 hours)"|24 hours||||units on a scale||Inter-Quartile Range|Mean
2641123|NCT01749033|Primary|The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia.|The primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphagia, sore throat and dysphonia 24 hours after airway placement.|24 hours||||Participants|||Count of Participants
2641124|NCT01749033|Primary|The Primary Outcomes for This Study Will be Postoperative Dysphagia.|The primary outcomes for this study will be postoperative pharyngolaryngeal complication of dysphagia 24 hours after airway placement. This is assessed by a study team member during the 24 hour follow up or reported by the participant.|24 hours||||Participants|||Count of Participants
2641125|NCT01749033|Primary|The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphonia|The primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphonia. Difficulty in speaking as assessed by the study team and reported by the participant 24 hours after LMA airway placement.|24 hours||||Participants|||Count of Participants
2641126|NCT01749033|Primary|Number of Subjects Who Present With Postoperative Sore Throat|The primary outcomes for this study will be postoperative pharyngolaryngeal complications of sore throat as reported by the participant.|24 hours||||Participants|||Count of Participants
2641127|NCT01748955|Secondary|Change in Suicidal Ideation (SSI Score)|Beck Scale of Suicidal Ideation Minimum Value = 0 Maximum Value = 38 Higher score is more severe suicidal thoughts|Measured at Baseline and Week 8||||units on a scale||Standard Deviation|Mean
2641128|NCT01748955|Primary|Percent Change in Contrast of Parameter Estimates (COPE)|"% change in COPE = (Post-treatment COPE - Pre-treatment COPE) / Pre-treatment COPE COPE is measured during Monetary Incentive Delay Task.~Task conditions are:~Reward= BOLD signal when subject wins 5 cents vs. wins 0 cents Punishment= BOLD signal when subject loses 5cents vs. loses 0 cents"|Measured at Baseline (pre-treatment) and Week 8 (post-treatment)|Major depressive disorder with suicidal thoughts or past suicide attempt.|||Percentage change||Full Range|Mean
2641129|NCT01748942|Secondary|Days With Feeding Tube||12 months||||days||Full Range|Median
2641130|NCT01748942|Secondary|UM-QOL Eating|"The University of Michigan Head and Neck Quality of Life Questionnaire (UM-QOL) is 20 item, 1-5 scale, questionnaire that measures how much the patient has been bothered during various activities as a result of head and neck condition or treatment in the past four weeks with 1= Not at all and 5=Extremely. The scores are calculated using a Likert Scale, which transforms the 1-5 choices into a 0-100 scale with 100 being normal and 0 being poor quality of life. This test contains separate domains (eating, etc.) that can be scored independently. Scores were analyzed between cohorts pre and post operatively."|21 days||||units on a scale||Standard Deviation|Mean
2641131|NCT01748942|Secondary|Opioid Use||3 days||||mg of oxycodone equivalent||Standard Deviation|Mean
2641132|NCT01748942|Secondary|PSS Normalcy of Diet|"Performance Status Score (PSS) - Normalcy of Diet score is a 0-100 scale that measures diet restrictions with 0= Non-oral feeding (tube fed) and 100 = Full diet (no restrictions)"|30 days||||units on a scale||Standard Deviation|Mean
2641133|NCT01748942|Secondary|Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge)|Kaplan-Meier functions will be fitted to compare the length of hospital stay between the experimental and control groups.|Up to 21 days||||days||Standard Deviation|Median
2641134|NCT01748942|Secondary|Eating Assessment Tool (EAT)-10 Scores|"Statistical Analysis between placebo and steroid cohorts to assess differences. The Eating Assessment Tool (EAT-10) is a 10 item questionnaire that evaluates swallowing and the extent of how problematic with certain eating activities. Questions are answered using a five point (0-4) plus Not Applicable scale with 0 = No problem and 4= Severe problem. A descriptive time plot will be produced for EAT-10 scores using baseline and postoperative measurements on days 3 and day 7-21. Descriptive statistical analyses will be conducted for a summary of EAT-10 scores at baseline, days 3 and day 7-21 after surgery. A linear mixed effects model will be used to compare the EAT-10 scores between the two groups."|Up to 12 months||||units on a scale||Standard Deviation|Mean
2641135|NCT01748942|Secondary|Complications Associated With Postoperative Corticosteroid Use After TORS|A descriptive statistical analysis will be conducted on complications.|Up to 30 days||||Participants|||Count of Participants
2641136|NCT01748942|Primary|Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale|"Visual Analog Scale (VAS) is a 0-10 scale for patients to indicate intensity level of pain with 0 indicating No pain and 10 indicating Worst possible, unbearable, excruciating pain. A descriptive time plot of VAS scores will be produced for all enrolled subjects, with loess curve fitted separately for the experimental and control groups. A linear mixed effects model will be used to compare the pain VAS scores between the experimental and control groups."|21 days||||units on a scale||Standard Deviation|Mean
2641137|NCT01748916|Primary|Pharmacokinetics of Carotenoid Absorption From Papaya, Carrot and Tomato|The primary goal of this research is to investigate whether papaya can deliver increased quantities of carotenoids when compared to carrot and tomato. An area under the curve for concentration of carotenoids (from triglyceride rich lipoprotein (TRL) fraction of plasma) over time will be determined to quantify absorption, after subjects consume a meal containing papaya, carrot or tomato.|8 post-prandial blood samples over 9.5 hours||||nmol*h/L||Inter-Quartile Range|Median
2641170|NCT01748162|Secondary|Severity of Croup Episodes|Severity of recurrent croup episodes based on Westley Croup scale (0 - 17, where 0 is mildest croup symptoms and 17 is most severe symptoms.)|1 year|No participants completed to 1 year because of early study termination.||||||
2641138|NCT01748890|Primary|The Number of Core Biopsies in These Targeted Regions|From elastography-prostatectomy pathology correlation, the following data will be obtained, 1) The number of planned core biopsies that would intersect foci of prostate carcinoma, 2) The Gleason Score that would be obtained, assuming that elastographically targeted biopsies sample the targeted region.|Participants will be followed until prostatectomy pathology is available (average 1 week)|insufficient recruitment for analysis||||||
2641139|NCT01748799|Secondary|Cannabis Withdrawal|Withdrawal symptoms were assessed using the Cannabis Withdrawal Scale (CWS) (Minimum-Maximum Scores 0-190, high scores represent more withdrawal) and Cannabis Withdrawal Checklist (CWC) (Minimum-Maximum Scores 0-48, high scores represent more withdrawal) by establishing comparisons between Sativex/Placebo and Smoke as usual conditions (4 interventions: Fixed Sativex, Fixed Placebo, Self-titrated Sativex, Self-titrated Placebo and 4 corresponding Smoke as usual conditions).|8 weeks|Only 9 of the 16 participants recruited completed the whole experimental sequence (participants were assigned to 1 of 8 different experimental sequences in a randomized order).|||units on a scale||Standard Deviation|Mean
2641140|NCT01748799|Secondary|Tolerability of Sativex in Persons That Are Cannabis Dependent|To assess what number of participants might withdrew due non-tolerability of Sativex|8 weeks|Data from 16 participants enrolled in the study was analyzed, none of the participants withdrew due non-tolerability of Sativex|||participants|||Number
2641141|NCT01748799|Primary|Feasibility|Feasibility will be assessed by analysing how many participants can be recruited/complete the whole (randomly assigned) experimental sequence with a period of one year.|12 months|16 participants were enrolled in the study, 9 participants completed the whole (randomly assigned) experimental sequence|||participants|||Number
2641142|NCT01748760|Primary|Number of Participants Who Repoorted a Suicide Event|A suicide event is either a suicide attempts (actual, aborted, interrupted), or emergency interventions to intercede an attempt.|6 months||||participants|||Number
2641143|NCT01748695|Primary|Safety and Tolerability of V158866 Compared to Placebo|Safety and tolerability were measured by occurrence of treatment-emergent adverse events; data represents the number of subjects who experienced treatment-emergent adverse events during each treatment period.|4 weeks||||Participants|||Count of Participants
2641144|NCT01748695|Primary|Mean Pain Intensity (NRS)|Numerical Rating Scale, measuring the intensity of pain from 0 to 10, with 0 being no pain and 10 being worst pain imaginable. The comparison of the overall pain intensity, calculated as the mean of the last 7 days on treatment, for each treatment period (V158866 compared to placebo).|4 Weeks||||units on a scale||Standard Error|Mean
2641145|NCT01748643|Secondary|Forced Vital Capacity|Forced vital capacity is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used.|Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))||||percent change from baseline||Standard Deviation|Mean
2641146|NCT01748643|Secondary|Forced Expiratory Volume in 1 Second|Forced expiratory volume in 1 second is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used.|Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))||||percent change from baseline||Standard Deviation|Mean
2641147|NCT01748643|Secondary|Peak Expiratory Flow|Peak expiratory flow is measured with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used.|Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone))||||percent change from baseline||Standard Deviation|Mean
2641148|NCT01748643|Primary|Duration of Surgery|Measured from the time of first skin incision to completion of skin closure.|Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h||||minutes||Standard Deviation|Mean
2641149|NCT01748643|Primary|Number of Intra-abdominal Pressure Rises > 18cmH2O|The number of intra-abdominal pressure rises > 18cmH2O detected by the intra-abdominal CO2 insufflator.|Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h||||number of intra-abdominal pressure rises||Standard Deviation|Mean
2641150|NCT01748643|Primary|Subjective Evaluation of the View on the Operating Field by the Surgeon|"At the end of surgery, the view on the operating field will be graded by the surgeon using a 5-point rating scale:~Extremely poor~Poor~Acceptable~Good~Optimal"|Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h||||units on a scale||Standard Deviation|Mean
2641151|NCT01748552|Secondary|Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time 0 to 6 h Postdose [AUEC(0-6)]|LS mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.|Baseline (predose for Part A and Day -1 time-matched for Part B), up to 6 h postdose (1.5, 2.5, 4, 4.5, 5, and 6 h postdose)|All participants who received at least 1 dose of the study drug or placebo and had sufficient pharmacodynamic data to calculate C-peptide AUEC(0-6).|||picomoles*hour per liter (pmol*h/L)||Standard Error|Least Squares Mean
2641152|NCT01748552|Secondary|Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time 0 to 24 h Postdose [AUEC(0-24)]|Least Squares (LS) mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.|Baseline (predose for Part A and Day -1 time-matched for Part B), up to 24 h postdose (1.5, 2.5, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18, and 24 h postdose)|All participants who received at least 1 dose of the study drug or placebo and had sufficient pharmacodynamic data to calculate glucose AUEC(0-24).|||millimoles*hour per liter (mmol*h/L)||Standard Error|Least Squares Mean
2641153|NCT01748552|Secondary|PK: Maximum Concentration (Cmax) of LY2922083||Predose up to 72 h after each dose of study drug (Part A: predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose. Part B: predose, 0.5, 1.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose.)|All participants who received at least 1 dose of the study drug and had sufficient PK data to calculate Cmax.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2641154|NCT01748552|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve From Time 0 to Infinite Time [AUC(0-∞)] of LY2922083||Predose up to 72 hours (h) after each dose of study drug (Part A: predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose. Part B: predose, 0.5, 1.5, 4, 6, 12, 18, 24, 36, 48 and 72 h postdose.)|All participants who received at least 1 dose of the study drug and had sufficient PK data to calculate AUC(0-∞).|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2641155|NCT01748552|Primary|Number of Participants With 1 or More Serious Adverse Event(s) (SAEs)|Events deemed by the Investigator to be SAEs related to study drug administration are reported. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through study completion (up to 70 days)|Safety population: all participants who received at least 1 dose of study drug or placebo, and had at least 1 postdose safety assessment.|||Participants|||Count of Participants
2641156|NCT01748292|Secondary|CNVM Lesion Size|CNVM lesion size at baseline, compared to baseline to weeks 24-28, baseline to weeks 48-56, baseline to weeks 72-82, baseline to week 104, baseline to weeks 128-132 and baseline to week 156, as determined by fluorescein angiography.|6, 12, 18, 24, 30, and 36 months|This analysis was never performed because we were logistically unable to collect the data.||||||
2641157|NCT01748292|Secondary|Percentage of Patients With Persistent Leakage on Fluorescein Angiography|Percentage of subjects with persistent leakage on fluorescein angiography from baseline through weeks 24-28, baseline to weeks 48-56, baseline to weeks 72-82, baseline to week 104, baseline to weeks 128- 132 and baseline to week 156.|6, 12, 18, 24, 30, and 36 months|This analysis was never performed because we were logistically unable to collect the data.||||||
2641158|NCT01748292|Secondary|Mean Change in Central Foveal Thickness|Mean change in central foveal thickness by SD-OCT from baseline to weeks 48-57, baseline to week 104 and baseline to week 156.|12, 24, and 36 months|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals in the Treat and Extend arm, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||microns||Standard Error|Mean
2641159|NCT01748292|Secondary|Percentage of Subjects With Persistent Active Exudation on SD-OCT|Percentage of subjects with persistent active exudation on SD-OCT from baseline through weeks 48-57 (week closest to week 52), baseline through week 104 and baseline through week 156.|12, 24, and 36 months|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals in the Treat and Extend arm, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||Participants|||Count of Participants
2641160|NCT01748292|Secondary|Total Number of Office Visits and Imaging Studies Performed During Study Period|Total number of office visits and imaging studies performed from baseline through weeks 24-28 (week closest to week 26), baseline through weeks 48-56 (week closest to week 52), baseline through weeks 72-82 (week closest to week 78), baseline through week 104, baseline through weeks 128-132 (week closest to week 132) and baseline through week 156|6, 12, 18, 24, 30, and 36 months|Per protocol, imaging was conducted at each study visit and is assumed to be perfectly correlated with the number of visits. Therefore, only visits were specifically analyzed. Additionally, given the high correlation between number of visits and injections administered (reported previously), this analysis was performed only at M12, M24, and M36.|||scheduled visits completed|||Number
2641161|NCT01748292|Secondary|Total Number of Intravitreal Injections Required|Total number of intravitreal injections required from baseline through weeks 48-57 (week closest to week 52), baseline through week 104 and baseline through week 156.|12, 24, and 36 months|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals in the Treat and Extend arm, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||injections||Full Range|Mean
2641162|NCT01748292|Secondary|Incidence and Severity of Adverse Events (Ocular and Non-ocular)|Incidence and severity of adverse events both ocular and non-ocular|36 months||||Participants|||Count of Participants
2641163|NCT01748292|Primary|Mean Change in BCVA by ETDRS Letter Score From Baseline|Mean change in Best-Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score from baseline through weeks 24-28, baseline through weeks 48-56, baseline through weeks 72-82, baseline to week 104, baseline through weeks 128-132 and baseline to week 156. The ETDRS protocol is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning. The scale ranges from 0 to 100 letters|6, 12, 18, 24, 30, and 36 months|All participants were included in analysis. Due to participant attrition, missed visits, and variable follow-up intervals in the Treat and Extend arm, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||ETDRS BCVA Letters||Standard Error|Mean
2641164|NCT01748240|Primary|Response Rate|"All eligible patients will be treated with Azacitidine and oral vorinostat for 6 cycles of 28 days.~The response rate (CR, PR, HI or marrow CR) will be evaluated after six cycles, according to IWG 2006.~In patients still responding after six cycles, the drugs will continue to be supplied, and follow up until death or unacceptable tolerance will be continued in all patients.~Complete Response (CR): Bone marrow: less than 5% myeloblasts with Peripheral blood: HI responses).~Partial remission (RP): Bone marrow blasts decreased by at least 50% but still more than 5% with Peripheral blood: HI responses).~Marrow CR:Bone marrow: maximum of 5% myeloblasts and decrease by at least 50% over pretreatment~HI (hematologic improvement)~Erythroid response: Hgb increase at least by 1.5 g/dL~Platelet response: Increase from less than 20x109/L to more than 20x109/L and by at least 100%~Neutrophil response: At least 100% increase and an absolute increase of at least 0.5x109/L"|6 month||||percentage of response||95% Confidence Interval|Number
2641165|NCT01748227|Secondary|Pain Centrality Scale|Possible range 10-50. Higher scores indicate higher pain centrality, i.e., worse outcomes.|4 month assessment||||units on a scale||Standard Deviation|Mean
2641166|NCT01748227|Secondary|Patient Reported Outcome Measurement System (PROMIS)|Possible scores range 0-100. Higher scores represent higher pain interference. Thus lower scores represent better outcomes.|Change from baseline to 4 month assessment||||units on a scale||Standard Deviation|Mean
2641171|NCT01748162|Primary|Quantity of Recurrent Episodes|Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject.|1 year|No participants completed to 1 year because of early study termination.||||||
2641178|NCT01748045|Secondary|Evidence of Chronic Respiratory Morbidity at 12 Months Corrected Gestational Age (CGA)|defined by a validated system of parental diaries and pulmonary questionnaires, as well as review of medical records (medical visits, respiratory medication use, emergency room visits, and hospital re-admissions)|12 months corrected gestational age|Analysis not performed at one year corrected age, since study closed.|||Participants|||Count of Participants
2641179|NCT01748045|Secondary|Diagnosis of Bronchopulmonary Dysplasia (BPD)|Diagnosis of BPD by oxygen challenge test at 36 weeks post menstrual age (PMA) for infants born between 30 and 32 weeks gestational age (GA). For those born 32 1/7 - 36 weeks, an oxygen challenge test was performed at 1-2 months of age.|At 36 weeks postmenstrual age or 1-2month of age||||Participants|||Count of Participants
2641180|NCT01748045|Secondary|Total Duration of Supplemental Oxygen|Participants were followed for the duration of hospital stay for use of supplemental oxygen|From Hospital Admission through discharge||||days||Standard Deviation|Mean
2641181|NCT01748045|Secondary|Total Length of Hospital Stay|participants who were followed for the duration of hospital stay|From hospital admission through discharge||||days||Standard Deviation|Mean
2641182|NCT01748045|Secondary|Number of Participants Who Had the Need for Exogenous Surfactant||7 days||||Participants|||Count of Participants
2641183|NCT01748045|Primary|Number of Participants Who Were Alive Without the Need for Intubation or Mechanical Ventilation Within the First Week of Life||7 days||||Participants|||Count of Participants
2641184|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17|OAT, Q17: Participant understood reason excess liquid was present after a partial-dose injection. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. All participants in the 10 mcg device-10 mcg dose and 20 mcg device-20 mcg dose (total 12 participants) are stated as not applicable as they tested the full dose."|||participants|||Number
2641185|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16|OAT, Q16: Evidence of mechanical malfunction/defect. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
2641186|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b|OAT, Q14b: Participant successfully expelled/injected the assigned dose (per Dose Card). Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
2641187|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13|"OAT, Q13: Was there any difficulty/obstruction encountered in expelling dose? Observer responses were reported as follows: Yes, No. A Yes response indicated failure according to the SAP. Q11 to Q17 made up Segment 5: Performing the Simulated Injection."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
2641188|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12|"OAT, Q12: Participant successfully expelled the dose into the target. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
2641189|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11|"OAT, Q11: Participant successfully set the correct dose (as assigned). Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
2641190|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10|OAT, Q10: Evidence of mechanical malfunction/defect for Segment 4. Observer responses were reported as follows: Yes, No. Q9 and Q10 made up Segment 4: Setting the Dose.|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
2641191|NCT01747928|Secondary|Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9|"OAT, Q9: Participant was able to set a dose (any dose) for delivery. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q9 and Q10 made up Segment 4: Setting the Dose."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
2641192|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8|OAT, Q8: Evidence of mechanical malfunction/defect for Segment 3. Observer responses were reported as follows: Yes, No. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
2641193|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7|"OAT, Q7: Participant depressed the plunger correctly to de-aerate the syringe. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the SAP. Q6 to Q8 made up Segment 3: De-aeration of the Syringe."|Day 1|FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
2641194|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6|"OAT, Q6: De-aeration step performed successfully. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q6 to Q8 made up Segment 3: De-aeration of the Syringe."|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category."|||participants|||Number
2642862|NCT01732835|Secondary|LV Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||g||Standard Deviation|Mean
2641195|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5|OAT, Q5: Evidence of mechanical malfunction/defect for Segment 2. Observer responses were reported as follows: Yes, No. Q3 to Q5 made up Segment 2: Mixing the Solution.|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category."|||participants|||Number
2641196|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4|"OAT, Q4: Participant positioned piston correctly. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the SAP. Q3 to Q5 made up Segment 2: Mixing the Solution."|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category."|||participants|||Number
2641197|NCT01747928|Secondary|Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3|"OAT, Q3: Participant performed mixing step correctly. Observer responses were reported as follows: Yes, No. A No response indicated failure according to the OAT. Q3 to Q5 made up Segment 2: Mixing the Solution."|Day 1|"FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the did not participate category."|||participants|||Number
2641198|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2|OAT, Q2: Evidence of mechanical malfunction or defect for Segment 1. Observer responses were reported as follows: Yes, No. Q1 and Q2 made up Segment 1: Assembly of Components.|Day 1|FAS: all protocol defined valid attempts to perform the study procedures as documented in the OAT. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant in the 10 mcg device-2.5 mcg dose was excluded as failure at Q1 did not involve mechanical failure or defect.|||participants|||Number
2641199|NCT01747928|Secondary|Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1|"OAT, Q1: Participant assembled the components correctly. Observer responses were reported as follows: Yes, No. A No answer indicated failure according to the OAT. Q1 and Q2 made up Segment 1: Assembly of Components."|Day 1|FAS: all protocol defined valid attempts to perform the study procedures as documented in the OAT. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.|||participants|||Number
2641200|NCT01747928|Secondary|Time Required to Perform Segments 1 to 5|Steps involved while using the Caverject Impulse Delivery System were categorized into segments: Segment 1 (Assembly While Using the Caverject Impulse Delivery System), Segment 2 (Mixing the Solution), Segment 3 (De-aerating the Syring While Using the Caverject Impulse Delivery System), Segment 4 (Setting the Dose) and Segment 5 (Performing the Injection While Using the Caverject Impulse Delivery System).|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT. n=number of participants analyzed for that segment.|||seconds||Standard Deviation|Mean
2641201|NCT01747928|Secondary|Number of Participants Providing Responses to Any Question on the PAT|Number of participants providing responses on questions in the PAT. Questions were as follows: What step did you stop? Why?; Instructions provided were useful?; Instructions provided were clear?; Most difficult step?; Syringe easy to use?|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.|||participants|||Number
2641202|NCT01747928|Secondary|Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use?|Participant responses were reported as follows: Very easy, Somewhat easy, Somewhat difficult, Very difficult.|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.|||participants|||Number
2641203|NCT01747928|Secondary|Number of Participants With Categorical Responses to the PAT: Most Difficult Step?|Participant responses were reported as follows: No steps really difficult, Attaching needle, Mixing the solution, Getting the air out of syringe, Setting the dose, Pushing plunger, Other.|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.|||participants|||Number
2641204|NCT01747928|Secondary|Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear?|Participant responses were reported as follows: Very clear, Somewhat clear, Not very clear, Not clear at all.|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.|||participants|||Number
2641205|NCT01747928|Secondary|Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful?|Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All.|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.|||participants|||Number
2641206|NCT01747928|Post-Hoc|DSSR Based on the Primary Objective|"This post-hoc DSSR was calculated in order to provide a DSSR that recognized as a failure only those participants who were unable to successfully complete the overall injection task, regardless of whether they met with difficulties at any step."|Day 1|The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.|||percentage of participants||95% Confidence Interval|Number
2641207|NCT01747928|Primary|Delivery System Success Rate (DSSR)|"DSSR was defined as percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Dual Chamber Delivery System when relying on the modified Instructions for Use (IFU). The process was considered successful if the attempt was observed and documented by study personnel AND the participant didn't receive any operational/hands on demonstration on how to operate the plunger from study personnel AND after performing all preparatory steps, the participant was able to expel the dose to the selected plunger stop-point without any unexpected interruption."|Day 1|The full analysis set (FAS) consisted of all protocol defined valid attempts to perform the study procedure as documented in the Observer Assessment Tool (OAT).|||percentage of participants||95% Confidence Interval|Number
2641208|NCT01747915|Secondary|Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Primary Generalized Tonic-clonic (PGTC) Seizure Rate During the 12-Week Double-blind Treatment Phase|Percentage of participants with 50% or greater reduction from baseline in 28-day seizure rate during the 12 week double blind treatment phase were reported. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase])*28.|Day 1 up to Week 12|ITT population included all randomized participants who took at least 1 dose of investigational product during the double-blind treatment phase, have a baseline value and at least 1 post-baseline efficacy assessment.|||percentage of participants|||Number
2641209|NCT01747915|Primary|Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase|"All PGTC seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible 0 seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1)."|Day 1 up to Week 12|ITT population included all randomized participants who took at least 1 dose of investigational product during the double-blind treatment phase, have a baseline value and at least 1 post-baseline efficacy assessment.|||Seizure per 28 days||Standard Error|Least Squares Mean
2641210|NCT01747876|Secondary|Pharmacokinetics (PK) Parameter: Tmax|Tmax is the time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration or at steady-state (time). PK parameters were estimated from individual plasma concentration-time profiles using noncompartmental methods in Phoenix WinNonlin.|C1D1, C1D15|The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable drug concentration data.|||hour||Full Range|Median
2641211|NCT01747876|Secondary|Pharmacokinetics (PK) Parameter: Cmax|Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration or at steady-state (mass x volume-1). PK parameters were estimated from individual plasma concentration-time profiles using noncompartmental methods in Phoenix WinNonlin|C1D1, C1D15|The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable drug concentration data.|||ng/ml||Full Range|Median
2641212|NCT01747876|Secondary|Pharmacokinetics (PK) Parameter: AUC0-24|The AUC calculated to the end of a dosing interval (tau) following single dose or at steady-state (amount x time x volume-1). PK parameters were estimated from individual plasma concentration-time profiles using noncompartmental methods in Phoenix WinNonlin.|0,1, 2, 4, 8 hours post dose Cycle 1 Day 1 (C1D1) and Cycle 1 Day 15 (C1D15)|The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable drug concentration data.|||h*ng/ml||Full Range|Median
2641213|NCT01747876|Secondary|Duration of Response (DOR)|Assess the anti-tumor activity of LEE011 by RECIST 1.1. DOR was not assessed.|Every 2 cycles (cycle = 28 days) up to end of treatment, the maximum time a patient was on study was 1311 days|Full analysis set included all patients who received at least 1 dose of LEE011. Due to halted enrollment and/or lack of complete responses (CR) & partial responses (PR), efficacy analysis was only performed in terms of DOR for the patients treated during the dose-escalation part at the MTD and RDE. Therefore, Duration of response was not assessed.||||||
2641214|NCT01747876|Secondary|Time to Disease Progression (TTP) Per RECIST 1.1|TTP was assessed per Investigator, for the malignant rhabdoid tumor (MRT) & neuroblastoma patients for the pooled maximum tolerated dose (MTD) & recommended dose for expansion (RDE) according to RECIST 1.1 criteria using Kaplan-Meier method. Time to progression (TTP) is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to underlying cancer. If a patient had not had an event, time to progression was censored at the date of last adequate tumor assessment. At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Every 2 cycles (cycle = 28 days) up to end of treatment, the maximum time a patient was on study was 1311 days|Full analysis set (FAS) included all patients who received at least one dose of LEE011.|||months||95% Confidence Interval|Median
2641215|NCT01747876|Secondary|Overall Response Rate|This analysis was not done as there were no responders.|Every 2 cycles (cycle = 28 days) up to end of treatment, the maximum time a patient was on study was 1311 days|Full analysis set (FAS) included all patients who received at least one dose of LEE011. This analysis was not done as there were no responders.|||months||95% Confidence Interval|Median
2641216|NCT01747876|Primary|Incidence Rate of Dose Limiting Toxicities (DLTs) by Primary System Organ Class, Preferred Term and Treatment|A DLT was defined as an AE or clinically significant abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first 28 days of treatment with LEE011 and met any of the predefined criteria. For the purpose of dose-escalation decisions, DLTs were considered and included in the Bayesian Logistic Regression Model (BLRM). Patients who did not experience DLT during the first cycle were considered to have had sufficient safety evaluations if they were observed for ≥ 28 days following the first dose and were considered to have had enough safety data to conclude that a DLT did not occur. Patients who did not meet these minimum safety evaluation requirements were regarded as ineligible for the DDS. A patient with multiple DLTs within a primary system organ class is counted only once in the total row.|cycle 1 = 28 days (from the time of first dose)|Dose-determining analysis set consisted of all pts from safety set who either met the following minimum exposure criterion & had scheduled safety evaluations, or experienced a DLT. A patient was considered to have met the minimum exposure criterion if he/she had received at least 16 of 21 planned daily doses of LEE011 in first 28 days of dosing.|||Participants|||Number
2641217|NCT01747850|Secondary|Cannabis Use (Grams)|Amount of cannabis used in grams over the study duration until 6 month follow-up will be assessed|six months||||grams of cannabis||Standard Error|Mean
2658560|NCT01597388|Primary|Oxygen Saturation||28 Days|The analysis population consisted of all participants who received at least one dose of AZD2014.|||% Arterial Oxygen Saturation||Standard Deviation|Mean
2641218|NCT01747850|Secondary|Cannabis Craving|"Effect of Sativex on cannabis craving will be assessed using the Marijuana Craving Questionnaire (MCQ). Average Total score for the trial (6 months) is reported.~Participants rate the 12 items using a 7-item Likert scale ranging from strongly disagree to strongly agree, and the total score ranges from 4 to 28 (subscales compulsivity (mean items 2, 7 and 10), emotionality (mean items 4, 6 and 9), expectancy (mean items 5, 11 and 12) and purposefulness (mean items 1, 3 and 8); total score is the sum for the 4 subscales). Higher scores indicate more severe craving for marijuana."|six months||||Total Craving Scores||Standard Deviation|Mean
2641219|NCT01747850|Secondary|Withdrawal|"Effect of Sativex on withdrawal symptom scores will be assessed using the Marijuana Withdrawal Checklist (MWC). Average Total score for the trial (6 months) is reported.~Range 0 - 46. Higher scores indicate more severe symptoms associated with marijuana withdrawal."|six months||||Total Withdrawal score||Standard Deviation|Mean
2641220|NCT01747850|Secondary|Cannabis Use (in Days)|The percentage of days that participants self-reported use of cannabis over the study duration until 6 month follow-up will be assessed (i.e. smoking diary self-report)|six months||||percentage of days||Standard Deviation|Mean
2641221|NCT01747850|Primary|Tolerability|Assessment of tolerability will be determined by the number of subjects that withdrawal from the study due to SAEs.|six months||||Participants|||Count of Participants
2641222|NCT01747837|Secondary|Number of Participants With Major Complication|Number of Participants with Major Complication defined as death, stroke, myocardial infarction (MI) or any other serious adverse events related to the treatment or procedure within the first 30 days or through hospital discharge (whichever is longer)|average 30 days||||Participants|||Count of Participants
2641223|NCT01747837|Secondary|Number of Participants With Orthostatic Hypotension|Number of participants who developed of orthostatic hypotension|24 months||||Participants|||Count of Participants
2641224|NCT01747837|Secondary|Procedure Related Adverse Events|Procedure related adverse events including, but not limited to hematomas, pseudoaneurysms and renal artery stenosis.|24 months||||Events|||Number
2641225|NCT01747837|Secondary|Creatinine Measurements|Creatinine measurements|baseline, 6 months, 12 months, 24 months|data only available for those participants who returned for respective study visits|||µmol/L||Standard Deviation|Mean
2641226|NCT01747837|Secondary|BUN Measurements|Blood Urea Nitrogen (BUN) measurements|baseline, 6 months, 12 months, 24 months|data only available for those participants who returned for respective study visits|||mmol/L||Standard Deviation|Mean
2641227|NCT01747837|Secondary|Number of Occurrence of ICD Storm|The cumulative number of occurrences of ICD storm, defined as ≥3 appropriate shock therapies within 24 hours|24 months||||occurences|||Number
2641228|NCT01747837|Secondary|All-Cause Mortality|All-Cause Mortality|24 months||||Participants|||Count of Participants
2641229|NCT01747837|Secondary|Number of Episodes of Total VT Burden|Cumulative Number of episodes of Total VT burden|24 months||||Episodes|||Number
2641230|NCT01747837|Secondary|Number of Hospitalizations for Cardiovascular Causes|Cumulative number of Hospitalizations for Cardiovascular Causes|24 months|cumulative number of hospitalizations|||hospitalizations|||Number
2641231|NCT01747837|Secondary|Number of Occurrences of Inappropriate ICD Therapy|Number of occurrences of inappropriate shocks. Inappropriate ICD therapy are shocks given by the ICD for atrial fibrillation, supraventricular tachycardia or an abnormal sensing.|24 months||||Occurrences||Standard Deviation|Mean
2641232|NCT01747837|Secondary|Number of Occurrences of Appropriate ICD Therapy|Number of Occurrences of Appropriate ICD therapy assessed in the full intention-to-treat patient cohort. An Appropriate ICD therapy is defined as anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.|24 months||||Occurences||Standard Deviation|Mean
2641233|NCT01747837|Primary|Time to First Event Requiring ICD Therapy or Incessant VT|The primary endpoint of this study is the time to first event requiring implantable cardioverter defibrillator (ICD) therapy or Incessant VT. (Ventricular tachycardia (VT) occurring below the ICD rate cut-off); this will be assessed in the on-treatment patient cohort. An event requiring ICD therapy is defined as an anti-tachycardia pacing (ATP) or shock therapy for ventricular tachycardia or fibrillation.|24 months||||days||Standard Deviation|Mean
2641234|NCT01747811|Other Pre-specified|Change From Baseline in Beck Depression Inventory (BDI-II) Scores at 6 Weeks|The Beck Depression Inventory (BDI-II) is a self report scale utilized for measuring the severity of depression. Scores can range from 0-63 (0 meaning minimal depressive symptoms, and 63 being severe depressive symptoms). Participants are given this on baseline and post treatment.|Change from baseline at 6 weeks (post-treatment)||||units on a scale||Standard Deviation|Mean
2641235|NCT01747811|Secondary|Performance on Neuropsychological Assessment|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a neuropsychological assessment that measures different facets of memory including the following: immediate memory, visuospatial/constructional, language, attention, and delayed memory. This is given to all participants on both pre and post treatment visits. The total range for this scale is 40-160. Lower values represent a worse outcome, and higher values represent an improved outcome.|Change from baseline at 6 weeks (post-treatment)||||units on a scale||Standard Deviation|Mean
2641236|NCT01747811|Secondary|Actigraphy-measured Sleep Quality|Actigraphy is an objective measure that determines sleep vs. wake. It is a watch with an accelerometer worn on the wrist. Sleep quality is determined by the amount of time in bed divided by the amount of time sleeping (in minutes).|Change from baseline at 6 weeks (post-treatment)|We collected usable actigraphy from 29 participants. The 7 remaining participants had unusable actigraphy data.|||minutes||Standard Deviation|Mean
2641237|NCT01747811|Secondary|Score on Pittsburgh Sleep Quality Index (PSQI)|The Pittsburgh Sleep Quality Index is a self report measure of sleep quality. The overall score takes into account many different facets of sleep, such as sleep quality, sleep latency, sleep duration, sleep disturbances, etc. The scores range from 0-21, and any score that is equal to or greater than 5 is indicative of poor sleep quality.|Change from baseline at 6 weeks (post-treatment)||||units on a scale||Standard Deviation|Mean
2641296|NCT01746979|Primary|Overall Survival|Overall survival is defined as time from randomization to death or last day known to be alive.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years||||months||95% Confidence Interval|Median
2641238|NCT01747811|Secondary|Neural Activation During Functional Magnetic Resonance Imaging (fMRI) Executive Function Task|Change from baseline in left prefrontal cortical response during a multi source interference task at six weeks. Methods utilized to assess activity in the left prefrontal cortex/inferior frontal operculum included a regions of interest analysis.|Change from baseline performance at 6 weeks (post-treatment)|A total of 22 participants had useable data, 4 participants were excluded due to movement in the images.|||Percent Signal Change||Standard Deviation|Mean
2641239|NCT01747811|Primary|Performance on Multiple Sleep Latency Test (MSLT)|The MSLT is a objective measure of sleepiness. Participants will take a brief nap 3 times during the 1st and second visit. The period of time between wake and sleep onset will be utilized as an objective measure of sleepiness (in minutes). A mean value will be calculated for the entirety of the pre-treatment napping periods and for the post treatment visits.|Change from baseline performance at 6 weeks (post-treatment)||||minutes||Standard Deviation|Mean
2641240|NCT01747772|Primary|Liver Elasticity Value Measured Using Sonoelastography (SE)|Liver elasticity/stiffness was assessed via SE and compared against results of liver biopsy as read by a single pathologist using the Meta-analysis of Histological Data in Viral Hepatitis (METAVIR) 5-point scale (F [Fibrosis]0=no fibrosis, F1=portal fibrosis without septa, F2=portal fibrosis with few septa, F3=numerous septa without cirrhosis, and F4=cirrhosis). Using SE, fibrosis is measured in kilopascals (kPa) with normal values equaling approximately 5.5 kPa (normal liver stiffness ranges between 3.3-7.8 kPa). Significant Fibrosis (F3): = or > 7.6 kPa, Cirrhosis (F4): = or > 9.0- 26 kPa. A higher number corresponds to an increase in stiffness and hepatic fibrosis.|Day 1|The analysis population included all participants who completed the study and had adequate shear-wave sonoelastography (SWE) and liver biopsy data. 16 participants were excluded: 9 discontinued and 7 had inadequate SWE or biopsy data.|||kilopascals (kPa)||95% Confidence Interval|Mean
2641241|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Falls: Percentage of Participants With Falls at 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months , including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||percentage of participants|||Number
2641242|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Received Assistance at Home: Percentage of Participants Who Received Assistance at Home at 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||percentage of participants|||Number
2641243|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Emergency Situations: Percentage of Participants With Emergency Situations at 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||percentage of participants|||Number
2641244|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Number of Visits at Home: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||visits at home||Standard Deviation|Mean
2641245|NCT01747655|Secondary|Healthcare Resource Utilization (HCRU) Number of Office Visits: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|Participants were asked about their utilization of healthcare resources within the previous 3 months, including total number of office visits, total number of visits at home for Parkinson's disease, total number of emergency situations (overnight hospital stay, visit at emergency room, calls for immediate assistance [family/friend)], and calls to 911/emergency), received assistance at home (family/friend or paid caregiver), and falls. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||office visits||Standard Deviation|Mean
2641246|NCT01747655|Secondary|Parkinson's Disease Quality of Life Questionnaire (PDQ-8) Summary Index Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|Participants were asked to state how often they had encountered certain problems over the past four weeks using the following rating scale: Never (0), occasionally (1), sometimes (2), often (3), always or cannot do at all (4). The PDQ-8 summary index was derived as the sum of the single items divided by 32. Scores range from 0 to 100. A higher summary index score indicates a higher impairment of quality of life. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point.|Baseline (Week 0), at discharge from hospital, and 3, 6, and 12 months after hospital discharge|MAS population|||units on a scale||Standard Deviation|Mean
2641306|NCT01746901|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol|Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here ‘n’ signifies those participants who were evaluable for specified category.|||hour||Full Range|Median
2641247|NCT01747655|Secondary|Non-Motor Symptoms Assessment Scale for Parkinson's Disease (NMSS Rating Scale) Total Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|Non-motor symptoms assessed over the previous month were scored with respect to severity (0 = none, 1 = mild, 2 = moderate, 3 = severe) and with respect to frequency (1 = rarely, 2 = often, 3 = frequent, 4 = very frequent). The total NMSS score ranges from 0 to 360 with higher values indicating greater impairment and was calculated as the sum of all individual score values. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||units on a scale||Standard Deviation|Mean
2641248|NCT01747655|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) III (Motor Examination) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|The UPDRS III questionnaire consists of 14 questions on motor examinations rated from 0 (absent/normal) to 4 (extreme impairment). Questions 20-26 are multi-part questions in that they are evaluated separately for multiple body parts (for example, for the left and right hand). Counting each of these assessments leads to a total of 27 answers. The UPDRS III score ranges from 0 to 108 with higher values indicating greater impairment and was calculated as the sum of the 27 answers provided to the 14 questions. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point.|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||units on a scale||Standard Deviation|Mean
2641249|NCT01747655|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 39 (Clinical Fluctuations) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of off times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||units on a scale||Standard Deviation|Mean
2641250|NCT01747655|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 34 (Pain) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of off times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||units on a scale||Standard Deviation|Mean
2641251|NCT01747655|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 33 (Disability) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of off times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||units on a scale||Standard Deviation|Mean
2641252|NCT01747655|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 32 (Duration) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS IV questionnaire consists of 4 individual items that assess the degree of dyskinesias (Item 32: duration; Item 33: disability; and Item 34: pain) and clinical fluctuations (Item 39: percentage of off times of the waking day). Individual UPDRS IV item scores range from 0 to 4. Higher scores indicate a higher complication of therapy. Observed values are presented for each visit as well as LOCF at 12 months after discharge. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||units on a scale||Standard Deviation|Mean
2641253|NCT01747655|Secondary|Primary Reasons for Discontinuing Duodopa Treatment or for Discontinuing the Study|The primary reasons for stopping treatment with Duodopa or for discontinuing the study.|12 months|Participants in the MAS who stopped treatment with Duodopa or discontinued from study.|||participants|||Number
2641254|NCT01747655|Secondary|Percentage of Participants Who Continued With Jejunal Extension Tube of the Percutaneous Endoscopic Gastrostomy (PEG-J) Treatment|The percentage of participants who continued with PEG-J treatment after treatment via temporary naso-jejunal tube.|14 days|MAS population|||percentage of participants|||Number
2641255|NCT01747655|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 3, 6, and 12 Months After Hospital Discharge|"The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to 13 questions, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. UPDRS scores during On time (when PD symptoms are well controlled by the drug) are presented. n=the number of participants with data at baseline and given time point."|Baseline (Week 0) and 3, 6, and 12 months after hospital discharge|MAS population|||units on a scale||Standard Deviation|Mean
2641256|NCT01747655|Primary|Unified Parkinson's Disease Rating Scale (UPDRS) II (Activities of Daily Living) Score: Mean Change From Baseline to 12 Months After Hospital Discharge|"The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to 13 questions, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. UPDRS scores during On time (when PD symptoms are well controlled by the drug) are presented. Last observation carried forward (LOCF) was used for missing data."|Baseline (Week 0) and 12 months after hospital discharge|MAS population|||units on a scale||Standard Deviation|Mean
2658561|NCT01597388|Primary|Body Temperature||28 Days|The analysis population consisted of all participants who received at least one dose of AZD2014.|||°C||Standard Deviation|Mean
2641257|NCT01747629|Secondary|Terminal Plasma Half-life (t1/2) for Albuterol on Days 1 and 8|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.|||hour||Standard Deviation|Mean
2641258|NCT01747629|Secondary|Area Under the Concentration-time Curve From Time 0 (Pre-dose) to 24 Hours Post-dose(AUC0-24) for Albuterol on Day 8|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Day 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.|||pg*hr/mL||Standard Deviation|Mean
2641259|NCT01747629|Secondary|Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Infinity Post-dose(AUC0-inf) for Albuterol on Day 1|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Day 1|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.|||pg*hr/mL||Standard Deviation|Mean
2641260|NCT01747629|Secondary|Area Under the Concentration-time Curve From Time 0 (Pre-dose) to Last Time of Quantifiable Concentration (AUC0-t) for Albuterol on Days 1 and 8|"Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).~AUC0-t on Day 8 is not from pre-dose but at steady state."|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.|||pg*hr/mL||Standard Deviation|Mean
2641261|NCT01747629|Secondary|Area Under the Concentration-time Curve From Time 0 (Pre-dose) up to 6 Hours Post-dose (AUC0-6) for Albuterol on Days 1 and 8|"Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).~AUC0-6 on Day 8 is not from pre-dose but at steady state."|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.|||pg*hr/mL||Standard Deviation|Mean
2641262|NCT01747629|Secondary|Time to Observed Peak Plasma Concentration (Tmax) for Albuterol on Days 1 and 8|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.|||hour||Full Range|Median
2641263|NCT01747629|Secondary|Maximum Observed Plasma Drug Concentration (Cmax) for Albuterol on Days 1 and 8|Pharmacokinetic parameters of albuterol were determined on Day 1 after the first dose administration and at steady-state on Day 8. Day 1 serial (10-hr) blood samples for pharmacokinetics pre-dose (within 30 minutes prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5, 6, 8 and 10 hours (±10 minutes). Day 8 serial (6-hr) blood samples for pharmacokinetics pre-dose (within 30 min prior to dosing), and post-dose at the following times: 15 (±5) min, 30 (±5) min, and 1, 2, 3, 4, 5 and 6 hr (±10 min).|Days 1 and 8|Pharmacokinetic analysis set representing a subset of participants from the Albuterol MDPI treatment arm.|||pg/mL||Standard Deviation|Mean
2641264|NCT01747629|Secondary|Participants With Clinically Significant Vital Sign Assessments|"For both standard and serial vital signs, participants were seated for at least 5 minutes before vital signs were assessed. Heart rate was obtained prior to the blood pressure measurement. Serial heart rate and blood pressure were conducted in the sitting position prior to the spirometry assessment; baseline measures were taken pre-dose at -30 ± 5 and -5 minutes on Day 1. Day 85 serial vital sign measures were taken in the sitting position prior to spirometry assessments pre-dose at -30 ± 5 and -5 minutes, then post-dose at 30 (±5) minutes, 1hr (± 10 min), 2hr (± 10 min), 3hr (± 10 min), 4hr (± 10 min), 5hr (± 10 min) and 6 hr (± 10 min).~Serial heart rate and blood pressure measurements that were elevated to the following criteria were considered clinically significant:~Systolic blood pressure: > 160 beats/minute Diastolic blood pressure: >100 beats/minute Heart rate: >120 beats/minute"|Days 8 and 85|Safety analysis set|||participants|||Number
2641265|NCT01747629|Secondary|Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group|Physical exam was recorded as normal or abnormal based on physician assessment. Format for results is: Test Baseline/Endpoint. HEENT = head, eyes, ears, nose, throat.|Day 1 (Baseline), Day 85|Safety population. Only participants with both baseline and endpoint physical examination findings are summarized.|||participants|||Number
2642863|NCT01732835|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||mm Hg||Standard Deviation|Mean
2641266|NCT01747629|Secondary|Participants With Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Day 93|Safety analysis set|||participants|||Number
2641267|NCT01747629|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 85|Full analysis set of participants with data at the time point|||L*hr||95% Confidence Interval|Mean
2641268|NCT01747629|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 8|Full analysis set of participants with data at the time point|||L*hr||95% Confidence Interval|Mean
2641269|NCT01747629|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 1|Full analysis set|||L*hr||95% Confidence Interval|Mean
2641270|NCT01747629|Primary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average (by the trapezoidal rule) over six hours of the FEV1 AUC 0-6 measures adjusted for the baseline measure (i.e., change from baseline at each timepoint) recorded on days 1, 8 and 85 of the treatment period. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 1, Day 8 and Day 85|Full analysis set included all participants in the intent-to-treat population who received at least 1 dose of study medication and had at least 1 post-baseline assessment.|||L*hr||Standard Error|Mean
2641271|NCT01747551|Secondary|Duration of Objective Response|Duration of response is the time from date of first documented confirmed objective response to date of first documented progressive disease. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.|Tumor assessments were performed every 8 weeks and evaluated by independent, blinded radiologists. Patient follow-up (months) median (range) was 14.5 (1.1-49.8) and 18.8 (0.6-49.8) for mFOLFOX6/ziv-aflibercept and mFOLFOX6/placebo, respectively.|The analysis dataset is comprised of patients who achieved objective response except one patient on the mFOLFOX6+Placebo is missing data.|||months||Full Range|Mean
2641272|NCT01747551|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of patients achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Tumor assessments were performed every 8 weeks and evaluated by independent, blinded radiologists. Patients received a median (range) treatment duration (m) of 6.9 (0-23.3) and 6.4 (0-43.9) for mFOLFOX6/ziv-aflibercept and mFOLFOX6/placebo, respectively.|The analysis dataset is comprised of all patients with measurable disease at baseline.|||percentage of patients||95% Confidence Interval|Number
2641273|NCT01747551|Secondary|Grade 4 Treatment-Related Toxicity Rate|The percentage of patients who experienced maximum grade 4 treatment-related adverse event based on CTCAEv4 as reported on case report forms.|Adverse events were collected each cycle on treatment. Patients received a median (range) treatment duration (months) of 6.9 (0-23.3) and 6.4 (0-43.9) for mFOLFOX6/ziv-aflibercept and mFOLFOX6/placebo, respectively.||||percentage of participants||95% Confidence Interval|Number
2641295|NCT01746979|Secondary|Progression Free Survival|Progression Free Survival is defined as the time from randomization to either first observation of progressive disease or occurrence of death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years||||months||95% Confidence Interval|Median
2658562|NCT01597388|Primary|Heart Rate||28 Days|The analysis population consisted of all participants who received at least one dose of AZD2014.|||beats/min||Standard Deviation|Mean
2641274|NCT01747551|Primary|6-month Progression-free Survival (PFS)|6-month PFS is the percent probability of patients remaining alive and progression-free at 6-months from randomization estimated using Kaplan-Meier methods. PFS was measured as the time from randomization to 1st documented disease progression (PD) or death. Patients alive without PD were censored at the earliest of the date of last progression-free disease assessment or start of non-protocol therapy. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Tumor assessments were performed every 8 weeks and evaluated by independent, blinded radiologists. Patient follow-up was 6 months.|The analysis dataset is comprised of all randomized patients.|||percent probability||95% Confidence Interval|Number
2641275|NCT01747499|Secondary|Rate of Chronic GvHD||One year after transplant|One patient in Phase II cohort was enrolled and treated with 1 cycle but was ultimately ineligible following a laboratory error and is not evaluable for this outcome measure.|||Participants|||Count of Participants
2641276|NCT01747499|Secondary|Number of Participants Who Relapsed Within the First Year of Transplant|Recurrence of the original malignant disease after transplantation. The time to relapse is the time to the first observation of hematologic, radiographic, or cytogenetic changes, which result in characterization as relapse.|Within the first year of transplant|One patient in Phase II cohort was enrolled and treated with 1 cycle but was ultimately ineligible following a laboratory error and is not evaluable for this outcome measure.|||Participants|||Count of Participants
2641277|NCT01747499|Secondary|Treatment-related Mortality|Death that results from a transplant procedure-related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause.|Day +140|One patient in Phase II cohort was enrolled and treated with 1 cycle but was ultimately ineligible following a laboratory error and is not evaluable for this outcome measure.|||Participants|||Count of Participants
2641278|NCT01747499|Secondary|Overall Survival as Measured by Number of Participants Alive at 1 Year After Transplant|Date of transplant to the date of death from any cause.|One year after transplant|One patient in Phase II cohort was enrolled and treated with 1 cycle but was ultimately ineligible following a laboratory error and is not evaluable for this outcome measure.|||Participants|||Count of Participants
2641279|NCT01747499|Secondary|Rate of Grades III-IV aGVHD at Day +180.|GVHD rate and severity will be assessed based on modified Glucksberg criteria.|Day +180|One patient in Phase II cohort was enrolled and treated with 1 cycle but was ultimately ineligible following a laboratory error and is not evaluable for this outcome measure.|||Participants|||Count of Participants
2641280|NCT01747499|Primary|Phase II: Number of Participants With Grades II-IV Acute GvHD|GVHD rate and severity will be assessed based on modified Glucksberg criteria. Grade II-IV and III-IV aGVHD in first 180 days after transplant will be assessed.|Day +180|One patient was enrolled and treated with 1 cycle but was ultimately ineligible following a laboratory error and is not evaluable for this outcome measure.|||Participants|||Count of Participants
2641281|NCT01747499|Primary|Phase I: to Determine the Maximum Tolerated Dose (MTD) of Azacitidine in Patients Undergoing Matched (8 Out of 8) Unrelated Donor Transplant for Any Hematological Malignancy in Remission or With Stable Disease.|The MTD is defined as the dose level immediately below the dose level at which patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity.|28 days||||mg/m^2|||Number
2641282|NCT01747486|Primary|Number of Patients Achieving Complete Response Within 3 Months|Complete response (including complete response with incomplete marrow recovery) within 3 months (in evaluable patients). The eveluable set comprise of patients who have received CART19 at intended dose level and completed at least 3-month follow-up after the infusion or discontinued due to disease progression, new cancer therapy or death.|3 months|The Evaluable Set comprised all patients who received high dose (1-5×10^8) or low dose (1-5×10^7) CTL019 transduced cells as randomized, and completed at least 3-month follow-up after the infusion or discontinued due to disease progression, new cancer therapy or death.|||Participants|||Count of Participants
2641283|NCT01747343|Other Pre-specified|Change in the Mean Number of Self-initiations to Sit on the Toilet Across Children||2 months minus baseline||||Self-initiations||Standard Deviation|Mean
2641284|NCT01747343|Secondary|Change in the Mean Percentage of Appropriate Eliminations Across Children||2 months minus baseline||||Percentage of opportunities||Standard Deviation|Mean
2641285|NCT01747343|Primary|Change in the Mean Number of Accidents Across Children||2 months minus baseline||||Accidents||Standard Deviation|Mean
2641286|NCT01747330|Secondary|Number of Participants With Clinical Relevant Safety Laboratory Values|(hematology: hemoglobin, hematocrit, RBC count, WBC count, platelet count; biochemistry: glucose (fasting), creatinine, alkaline phosphatase, total bilirubin, ALAT (alanine amino transferase), ASAT (aspartate amino transferase), gamma-glutamyl transferase, uric acid, calcium, phosphate, potassium, serum pancreatic lipase; urinalysis (dipstick): glucose, blood, albumin, pH)|3 months|Full Analysis subject sample|||participants|||Number
2641287|NCT01747330|Secondary|Number of Participants With Findings During Physical Examination|A physical examination was conducted by the physician. All abnormal findings were recorded as medical histories if present prior to start of study drug or as AEs otherwise. There was no separate documentation of physical examination findings in this study.|3 months|Full Analysis subject sample|||participants|||Number
2641288|NCT01747330|Secondary|Pulse|Change from Baseline at Day 84|3 months||||bpm||Standard Deviation|Mean
2641289|NCT01747330|Secondary|Number of Subjects With Adverse Events||4 months|Full Analysis subject sample|||participants|||Number
2641290|NCT01747330|Primary|Subject's Acceptance of Treatment|Acceptance to Creon Micro. The caregiver should give his/her opinion based on the following scale: very good, good, moderate, and unsatisfactory.|3 months|Full Analysis subject sample|||percentage of participants|||Number
2641291|NCT01747330|Primary|Stool Consistency|Assessment of stool consistency by the caregiver on a daily basis: hard, formed/normal, soft, watery|3 months|Full Analysis subject sample|||% of days with normal stool consistency||Standard Deviation|Mean
2641292|NCT01747330|Primary|Stool Frequency|Average daily stool frequency during treatment period: Number of bowel movements per day|3 months|Full Analysis subject sample|||Bowel movements per day||Standard Deviation|Mean
2641297|NCT01746940|Primary|Immediate and Sustained Analgesic Success|The primary endpoint for this trial is analgesic success immediately after application of study drug and sustained throughout the diagnostic procedure or surgery for each nostril that received the study drug application. A subject will be considered a treatment success if they meet the following: Prior to the procedure or surgery, a 0 pain score on the 10 point pain scale (0=no pain, 10=unbearable pain) based on the Von Frey filament challenge after application of the assigned treatment solution (placebo, 4% or 10% Cocaine HCl). During the procedure or surgery, no further analgesic treatment is required (only 4% and 10% Cocaine HCl subjects who receive a procedure or surgery). Otherwise, the subject will be considered a treatment failure. Subjects with missing primary outcome data are marked as treatment failures in all treatment groups.|Prior to and During a one-day Surgery or Diagnostic Procedure|The analysis of primary outcome data is based on an intent-to-treat population, which includes all randomized subjects who received study drug and who are enrolled in the safety and efficacy phase of the study.|||proportion of particpants analyzed||95% Confidence Interval|Number
2641298|NCT01746901|Other Pre-specified|Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2)|Oxygen saturation of hemoglobin in blood (SpO2) was monitored using pulse oximetry continuously for 5 hours following dosing in the drug discrimination phase and continuously for 12 hours following dosing in the treatment phase, or longer at the discretion of the investigator. Individual measurements was collected in a sitting position. If SpO2 fall below 90 percent (%), the investigator might had administered oxygen via nasal cannula at a flow rate sufficient to maintain the SpO2 greater than or equal to 90%. Participants with fall in SpO2 below 90% were reported.|pre-dose up to 5 hours in drug discrimination phase; pre-dose up to 12 hours in intervention period|Safety analysis set included all participants who received at least 1 dose of study drug. This outcome measure was not planned to be analyzed in “Naloxone Challenge Phase”, as pre-specified in protocol.|||participants|||Number
2641299|NCT01746901|Other Pre-specified|Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2)|End-tidal carbon dioxide concentration in the expired air (EtCO2) was monitored using capnography in a sitting position. Criteria for clinically significant change in EtCO2 was based on investigator's discretion.|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 5 hours post-dose in drug discrimination phase; pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in intervention period|Safety analysis set included all participants who received at least 1 dose of study drug. This outcome measure was not planned to be analyzed in “Naloxone Challenge Phase”, as pre-specified in protocol.|||participants|||Number
2641300|NCT01746901|Other Pre-specified|Number of Participants With Clinically Significant Change in Vital Sign Examinations|Vital signs assessment included measurement of heart rate, systolic and diastolic blood pressures, respiratory rate and oral temperature. Criteria for clinically significant change in any vital sign examination was based on investigator's discretion.|Screening up to 7 days following last study drug administration (Day 8)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2641301|NCT01746901|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 3 - 7 days following last study drug administration. Symptoms of withdrawal following naloxone administration (naloxone challenge phase) were not collected as adverse events unless they met the criteria for an SAE. AEs included SAEs as well as non-serious AEs which occurred during the trial.|Screening up to 28 days after last study drug administration (Day 29)|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2641302|NCT01746901|Other Pre-specified|Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)dn] of Oxycodone|[AUC (0 - ∞)dn]= Dose normalized area under the plasma concentration versus time curve [AUC(dn)] from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0- t) plus AUC (t - ∞). Participants who received oxycodone were reported. Participants who received oxycodone were reported.|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||ng*hr/mL/mg||Standard Deviation|Mean
2641303|NCT01746901|Other Pre-specified|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone|Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast). Participants who received oxycodone were reported.|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.|||ng*hr/mL||Standard Deviation|Mean
2641304|NCT01746901|Other Pre-specified|Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour, 0-8 Hour 0-12 Hour and 0-24 Hour of Oxycodone|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Participants who received oxycodone were reported.|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
2641305|NCT01746901|Other Pre-specified|Plasma Terminal Half-Life (t1/2) of Oxycodone|Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||hours||Full Range|Median
2641522|NCT01745055|Secondary|Renal Clearance (CL R) for CP-690,550||0 (pre-dose) through 24 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||litre/hour (L/hr)||Standard Deviation|Mean
2641307|NCT01746901|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone|Participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest. Here ‘n’ signifies those participants who were evaluable for specified category.|||hours||Full Range|Median
2641308|NCT01746901|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol|Participants who received ALO-02 were reported. 6-Beta-naltrexol is metabolites of naltrexone.|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the PK parameters of interest.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2641309|NCT01746901|Other Pre-specified|Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of Oxycodone, Oxymorphone and Noroxycodone|Cmax[dn]=Dose normalized maximum observed plasma concentration of participants who received oxycodone and ALO-02 were reported. Oxymorphone and noroxycodone are metabolites of oxycodone.|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Parameter analysis set included all enrolled participants who received at least 1 dose of study drug and who had at least 1 of the Pharmacokinetic (PK) parameters of interest. Here ‘n’ signifies those participants who were evaluable for specified category.|||nanogram/milliliter/milligram||Standard Deviation|Mean
2641310|NCT01746901|Other Pre-specified|High: Time to Maximum (Peak) Effect (TEmax)|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours||Full Range|Median
2641311|NCT01746901|Other Pre-specified|High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x).|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours*mm||Standard Deviation|Mean
2641312|NCT01746901|Other Pre-specified|Drug Liking: Time to Maximum (Peak) Effect (TEmax)|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). TEmax = Time to maximum observed score."|0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours||Full Range|Median
2641313|NCT01746901|Other Pre-specified|Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x)."|0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours*mm||Standard Deviation|Mean
2641314|NCT01746901|Secondary|Pupillometry: Time to Maximum (Peak) Effect (TEmax)|Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. TEmax = Time to maximum observed score.|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours||Full Range|Median
2641315|NCT01746901|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour|Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours*mm||Standard Deviation|Mean
2641316|NCT01746901|Secondary|Pupillometry: Peak Effect (Emax)|Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties. Participants have the size of pupil measured using a pupillometer. Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions. The same eye for each participant was used for all measurements during the study. Emax = Maximum observed score.|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||mm||Standard Deviation|Mean
2641381|NCT01746511|Secondary|Peak Total Serum Bilirubin Level|Bilirubin levels were checked every 12 hours while the infant was under phototherapy. A bilirubin level was then to be checked at least twice, 8-12 hours or longer apart, following discontinuation of phototherapy.|from time of enrollment to time of discharge every 12 hours while under phototherapy, for a maximum of 10 weeks||||mg/dL||Standard Deviation|Mean
2641317|NCT01746901|Secondary|Dizzy: Time to Maximum (Peak) Effect (TEmax)|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours||Full Range|Median
2641318|NCT01746901|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours*mm||Standard Deviation|Mean
2641319|NCT01746901|Secondary|Dizzy: Peak Effect (Emax)|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||mm||Standard Deviation|Mean
2641320|NCT01746901|Secondary|Sleepy: Time to Maximum (Peak) Effect (TEmax)|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm)to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours||Full Range|Median
2641321|NCT01746901|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours*mm||Standard Deviation|Mean
2641322|NCT01746901|Secondary|Sleepy: Peak Effect (Emax)|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||mm||Standard Deviation|Mean
2641323|NCT01746901|Secondary|Nausea: Time to Maximum (Peak) Effect (TEmax)|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours||Full Range|Median
2641324|NCT01746901|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours*mm||Standard Deviation|Mean
2641325|NCT01746901|Secondary|Nausea: Peak Effect (Emax)|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||mm||Standard Deviation|Mean
2641326|NCT01746901|Secondary|Feel Sick: Time to Maximum (Peak) Effect (TEmax)|Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours||Full Range|Median
2641327|NCT01746901|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour|Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours*mm||Standard Deviation|Mean
2641328|NCT01746901|Secondary|Feel Sick: Peak Effect (Emax)|Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||mm||Standard Deviation|Mean
2641329|NCT01746901|Secondary|Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)|Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours||Full Range|Median
2641330|NCT01746901|Secondary|Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour|Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours*mm||Standard Deviation|Mean
2641331|NCT01746901|Secondary|Bad Drug Effects: Peak Effect (Emax)|Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||mm||Standard Deviation|Mean
2641332|NCT01746901|Secondary|Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)|Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours||Full Range|Median
2641333|NCT01746901|Secondary|Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour|Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours*mm||Standard Deviation|Mean
2641334|NCT01746901|Secondary|Good Drug Effects: Peak Effect (Emax)|Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||mm||Standard Deviation|Mean
2641335|NCT01746901|Secondary|Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)|Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours||Full Range|Median
2641336|NCT01746901|Secondary|Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour|Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).|0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours*mm||Standard Deviation|Mean
2641337|NCT01746901|Secondary|Any Drug Effects: Peak Effect (Emax)|Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||mm||Standard Deviation|Mean
2641338|NCT01746901|Secondary|Overall Drug Liking Effect at Hours 12, 24 and 36|"Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking)."|12, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||mm||Standard Deviation|Mean
2641339|NCT01746901|Secondary|Overall Drug Liking: Minimum Effect (Emin)|"Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking). Emin= Average observed score."|12, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||mm||Standard Deviation|Mean
2641361|NCT01746745|Secondary|Relative Abundance of LY2940680, the Metabolites of LY2940680, and LSN3185556 in Feces|Relative abundance was expressed and calculated as the percentage of the administered dose excreted in feces=[(percentage of radioactivity in peak)/100]*(percentage of dose in sample). Metabolites with a relative abundance ≤1% are not reported.|Predose up to 8 days postdose. Samples collected at 24-h intervals.|Enrolled participants who received study drug and had evaluable PK data.|||percentage of administered dose excreted||Standard Deviation|Mean
2641340|NCT01746901|Secondary|Overall Drug Liking: Mean Effect (Emean)|"Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking). Emean = Average observed score."|12, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||mm||Standard Deviation|Mean
2641341|NCT01746901|Secondary|Overall Drug Liking: Peak Effect (Emax)|"Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm = neither like nor dislike, and 100 mm= strong liking). Emax = Maximum observed score."|12, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||mm||Standard Deviation|Mean
2641342|NCT01746901|Secondary|Take Drug Again Effect at Hours 12, 24 and 36|"Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would). Emax = Maximum observed score."|12, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||mm||Standard Deviation|Mean
2641343|NCT01746901|Secondary|Take Drug Again: Minimum Effect (Emin)|"Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would). Emax = Maximum observed score."|12, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||mm||Standard Deviation|Mean
2641344|NCT01746901|Secondary|Take Drug Again: Mean Effect (Emean)|"Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would). Emax = Maximum observed score."|12, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||mm||Standard Deviation|Mean
2641345|NCT01746901|Secondary|Take Drug Again: Peak Effect (Emax)|"Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would). Emax = Maximum observed score."|12, 24, 36 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||mm||Standard Deviation|Mean
2641346|NCT01746901|Primary|High: Area Under Effect Curve (AUE) From 0-2 Hour|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.|pre-dose, 0.25, 0.5, 1, 1.5, 2 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours*mm||Standard Deviation|Mean
2641347|NCT01746901|Primary|High: Peak Effect (Emax)|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in treatment phase|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||mm||Standard Deviation|Mean
2641348|NCT01746901|Primary|Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the extreme left with strong disliking (score of 0 mm) and on the extreme right with strong liking (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours."|0.25, 0.5, 1, 1.5, 2 hours post-dose|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.|||hours*mm||Standard Deviation|Mean
2641349|NCT01746901|Primary|Drug Liking: Peak Effect (Emax)|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the extreme left with strong disliking (score of 0 mm) and on the extreme right with strong liking (score of 100 mm). Peak Effect (Emax) = Maximum observed score."|0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in treatment phase|Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.|||mm||Standard Deviation|Mean
2641362|NCT01746745|Secondary|Relative Abundance of LY2940680 and the Metabolites of LY2940680 in Urine|Relative abundance was expressed and calculated as the percentage of administered dose excreted in urine=[(percentage of radioactivity in peak)/100]*(percentage of dose in sample). Metabolites with a relative abundance ≤1% are not reported.|Predose up to 4 days postdose. Samples collected at 6-h intervals on Day 1 (0-6, 6-12, and 12-24 h postdose) and at 24-h intervals thereafter.|Enrolled participants who received study drug and had evaluable PK data.|||percentage of administered dose excreted||Standard Deviation|Mean
2642864|NCT01732835|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||mm Hg||Standard Deviation|Mean
2641350|NCT01746862|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs|An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. For the Saizen Test Group, TEAEs were defined as events that occurred or worsened at or after the first administration of treatment and for the Saizen Control Group, TEAEs were defined as events that occurred or worsened at or after the randomization.|Baseline up to Month 13|Safety analysis set (SAS) included all randomized subjects who received at least 1 dose of planned trial treatment and had follow-up safety data. SAS also included the safety data for all subjects during non-treatment (the first 6 months after enrollment) period who belonged to control group.|||subjects|||Number
2641351|NCT01746862|Secondary|Percentage of Adherence to Study Treatment|Percentage of adherence to study treatment (adherence rate) was defined as the actual number of received treatments divided by the scheduled number of treatments multiplied by 100. The adherence rate for 6 months was calculated from Baseline to 6 months for the Saizen Test Group and from Month 6 to Month 12 for the Saizen Control Group.|6 months post-dose (Saizen Test Group and Saizen Control Group); 12 months post-dose (Saizen Test Group)|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||percentage of adherance||Standard Deviation|Mean
2641352|NCT01746862|Secondary|Change From Baseline in Serum Concentration of Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) at Month 6 and 12||Baseline, Month 6, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||mcg/L||Standard Deviation|Mean
2641353|NCT01746862|Secondary|Change From Baseline in Serum Concentration of Insulin-like Growth Factor-I (IGF-I) at Month 6 and 12||Baseline, Month 6, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||microgram/liter (mcg/L)||Standard Deviation|Mean
2641354|NCT01746862|Secondary|Change From Baseline in Height Standard Deviation Score (SDS) at Month 6 and 12|Height SDS was calculated as: Height SDS = (measured height - population mean) / population standard deviation, where mean and standard deviation were based on the Korean standard growth charts. SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) a subject's value was relative to the mean of the reference population. The scores were centred around zero. Negative score indicated a subject was smaller for their age/gender.|Baseline, Month 6, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||standard deviation score||Standard Deviation|Mean
2641355|NCT01746862|Secondary|Change From Baseline in Height at Month 6 and 12||Baseline, Month 6, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||centimeter (cm)||Standard Deviation|Mean
2641356|NCT01746862|Secondary|Change From Baseline in Height Velocity at Month 12|Baseline height is defined as the last available height measurement before randomization. Baseline height velocity = ([Baseline height minus height measurement obtained at least 12 months prior] / 12) * 12. Height velocity at Month 12 = ([Month 12 height minus height measurement obtained at least 12 months prior] / 12) * 12.|Baseline, Month 12|ITT analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here “Number of participants analyzed” signifies those subjects who were evaluable for this outcome measure.|||cm/year||Standard Deviation|Mean
2641357|NCT01746862|Primary|Change From Baseline in Height Velocity at Month 6 Using Last Observation Carried Forward (LOCF) Method|Baseline height is defined as the last available height measurement before randomization. Baseline height velocity = ([Baseline height minus height measurement obtained at least 6 months prior] / 6) * 12. Height velocity at Month 6 = ([Month 6 height minus height measurement obtained at least 6 months prior] / 6) * 12.|Baseline, Month 6|Intent-to-treat (ITT) analysis set included all randomized subjects, regardless of whether or not they received the treatment to which they were randomized, completed the study or had any protocol deviations. Here ”n” signifies those subjects who were evaluable for this outcome measure at the specified time points.|||centimeter/year (cm/yr)||Standard Deviation|Mean
2641358|NCT01746784|Secondary|Change in Biomarkers of CFTR Function|Sweat chloride millequivalents/Liter (mEq/L)|Change from baseline at Day 7|Change from baseline sweat chloride (mEq/L) to Study Day 14|||mEq/L||Standard Deviation|Mean
2641359|NCT01746784|Secondary|Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson standards were used to calculate percent predicted FEV1 (for age, sex, and height).|Change from baseline at Day 7|Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to Study Day 7|||percentage||Standard Deviation|Mean
2641360|NCT01746784|Primary|Safety and Tolerability|Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.|Over 7 treatment days and 7 days of follow-up|Treatment emergent adverse events by Grade 1 (mild) to 5 (fatal)|||participants|||Number
2641441|NCT01746095|Secondary|Change From Baseline in MRSA Sputum Density.||Day 15 of treatment period|Modified ITT (MITT) population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.|||Log10 CFU/mL||Standard Error|Least Squares Mean
2641363|NCT01746745|Secondary|Relative Abundance of LY2940680 and the Metabolites of LY2940680 in Plasma|Relative abundance was expressed and calculated as the percentage of plasma sample radioactivity=[(radioactivity in peak)/(radioactivity in sample)]*100. Metabolites with a relative abundance ≤6% are not reported.|Day 1 up to 3 days postdose. Samples collected at 2, 3, 4, 6, and 8 h postdose on Day 1 and every 24 h thereafter.|Enrolled participants who received study drug and had evaluable PK data.|||percentage of sample radioactivity||Standard Deviation|Mean
2641364|NCT01746745|Secondary|PK of Radioactivity: AUC(0 to Tlast)|AUC(0 to Tlast) of total radioactivity in plasma and whole blood are reported in nanograms*hour equivalents per gram (ng*h Eq/g).|Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter.|Enrolled participants who received study drug and had evaluable PK data.|||ng*h Eq/g||Geometric Coefficient of Variation|Geometric Mean
2641365|NCT01746745|Secondary|Plasma PK of LY2940680 and LSN3185556: Area Under the Concentration-Time Curve From Time 0 to the Last Time Point With a Measurable Concentration [AUC(0 to Tlast)]||Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter.|Enrolled participants who received study drug and had evaluable PK data.|||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2641366|NCT01746745|Secondary|PK of LY2940680, LSN3185556, and Radioactivity: Time of Maximum Observed Concentration (Tmax)|The Tmax of LY2940680, LSN3185556, and total radioactivity in plasma are reported, as well as the Tmax for total radioactivity in whole blood.|Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter.|Enrolled participants who received study drug and had evaluable PK data.|||h||Full Range|Median
2641367|NCT01746745|Secondary|PK of Radioactivity: Cmax||Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter.|Enrolled participants who received study drug and had evaluable PK data.|||nanogram equivalents per gram (ng Eq/g)||Geometric Coefficient of Variation|Geometric Mean
2641368|NCT01746745|Secondary|Plasma PK of LY2940680 and LSN3185556: Maximum Observed Concentration (Cmax)|The Cmax of LY2940680 and its equipotent active metabolite in the free base form, LSN3185556, is reported.|Predose up to 14 days postdose. Samples collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 h postdose on Day 1 and every 24 h thereafter|Enrolled participants who received study drug and had evaluable PK data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2641369|NCT01746745|Primary|Urinary Excretion of LY2940680 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered|The percentage of the total radioactive dose administered that was excreted in urine=[(amount of radioactivity recovered in urine)/(radioactive dose administered)]*100.|Predose up to 14 days postdose. Samples collected at 6-h intervals on Day 1 (0-6, 6-12, and 12-24 h postdose) and at 24-h intervals thereafter.|Enrolled participants who received study drug and had evaluable PK data.|||percentage of dose administered||Standard Deviation|Mean
2641370|NCT01746745|Primary|Fecal Excretion of LY2940680 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered|The percentage of the total radioactive dose administered that was excreted in feces = [(amount of radioactivity recovered in feces)/(radioactive dose administered)]*100.|Predose up to 14 days postdose. Samples collected at 24-h intervals.|Enrolled participants who received study drug and had evaluable pharmacokinetic (PK) data.|||percentage of dose administered||Standard Deviation|Mean
2641371|NCT01746732|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Norelgestromin||Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose|All participants who received at least one dose of study drug and had evaluable PK data.|||hour||Full Range|Median
2641372|NCT01746732|Primary|PK: Minimum Observed Drug Concentration (Cmin) of Norelgestromin||Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose|All participants who received at least one dose of study drug and had evaluable PK data.|||pg/ml||Geometric Coefficient of Variation|Geometric Mean
2641373|NCT01746732|Primary|PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Norelgestromin||Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose|All participants who received at least one dose of study drug and had evaluable PK data.|||pg*hour/ml||Geometric Coefficient of Variation|Geometric Mean
2641374|NCT01746732|Primary|PK: Maximum Concentration (Cmax) of Norelgestromin||Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose|All participants who received at least one dose of study drug and had evaluable PK data.|||pg/ml||Geometric Coefficient of Variation|Geometric Mean
2641375|NCT01746732|Primary|PK: Time of Maximum Observed Drug Concentration (Tmax) of Ethinyl Estradiol||Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose|All participants who received at least one dose of study drug and had evaluable PK data.|||hour||Full Range|Median
2641376|NCT01746732|Primary|PK: Minimum Observed Drug Concentration (Cmin) of Ethinyl Estradiol||Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose|All participants who received at least one dose of study drug and had evaluable PK data.|||pg/ml||Geometric Coefficient of Variation|Geometric Mean
2641377|NCT01746732|Primary|PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Ethinyl Estradiol||Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose|All participants who received at least one dose of study drug and had evaluable PK data.|||picogram x hour per ml (pg*hour/ml)||Geometric Coefficient of Variation|Geometric Mean
2641378|NCT01746732|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol||Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose|All participants who received at least one dose of study drug and had evaluable PK data.|||picogram per milliliter (pg/ml)||Geometric Coefficient of Variation|Geometric Mean
2641379|NCT01746511|Secondary|Length of Initial Round of Phototherapy|time start to time finally off phototherapy, including any breaks during which they were off|from time of enrollment to time of discharge, for a maximum of 10 weeks||||hours||Standard Deviation|Mean
2641380|NCT01746511|Secondary|Rate of Decline in Bilirubin Levels (mg/dL/hr)|Absolute change over time from peak to first discontinuation of phototherapy lights|from time of enrollment to time of discharge, for a maximum of 10 weeks||||mg/dL/hr||Standard Deviation|Mean
2642865|NCT01732835|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||mm Hg||Standard Deviation|Mean
2641382|NCT01746511|Secondary|Number of Episodes of Repeat Phototherapy|"Bilirubin levels are checked at regular intervals after phototherapy is discontinued to make sure levels are safe. Depending on rate of rise and predetermined unsafe bilirubin level, phototherapy may be restarted."|from time of enrollment to time of discharge, for a maximum of 10 weeks||||episodes of repeat phototherapy||Full Range|Median
2641383|NCT01746511|Primary|Total Number of Hours of Required Phototherapy||from time of enrollment to time of discharge, for a maximum of 10 weeks||||hours||Standard Deviation|Mean
2641384|NCT01746420|Primary|Maximum Grip Strength, Treated Subjects|A higher grip strength score indicates an improvement. A positive change from baseline indicates an improvement. Grip strength testing will be performed to evaluate changes in the strength and sincerity of effort as a result of treatment for lateral epicondylitis. Testing will be performed to assess the pain-free grip strength (performing the test until discomfort is felt) and maximum grip strength (performing the test to the maximum of their ability). The test will be performed while the patient is standing with the elbow in full extension, as this position has been used to assess grip strength in patients with lateral epicondylitis. A Jamar Plus+ Digital Hand Dynamometer with the grip in the second position will be used because the second position has been assumed to be the most reliable and consistent position. Patients will be asked to perform three repetitions of each test (pain-free and maximum) at each study interval and the mean score will be calculated and used for analysis.|Baseline, 4, 8, 12, and 24 weeks|Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points.|||lbs.||Standard Deviation|Mean
2641385|NCT01746420|Primary|Grip Strength Test, All Treated Subjects|Grip strength testing will be performed to evaluate changes in the strength and sincerity of effort as a result of treatment for lateral epicondylitis. Testing will be performed to assess the pain-free grip strength (performing the test until discomfort is felt) and maximum grip strength (performing the test to the maximum of their ability). The test will be performed while the patient is standing with the elbow in full extension, as this position has been used to assess grip strength in patients with lateral epicondylitis. A Jamar Plus+ Digital Hand Dynamometer with the grip in the second position will be used because the second position has been assumed to be the most reliable and consistent position. Patients will be asked to perform three repetitions of each test (pain-free and maximum) at each study interval and the mean score will be calculated and used for analysis.|Baseline, 4, 8, 12, and 24 weeks|Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points.|||lbs.||Standard Deviation|Mean
2641386|NCT01746420|Primary|Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects|"The Pain and disability measured by the Patient Rated Tennis Elbow Evaluation (PRTEE) is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as tennis elbow). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales:~PAIN subscale (0 = no pain, 10 = worst imaginable)~-Pain - 5 items~FUNCTION subscale (0 = no difficulty, 10 = unable to do)~Specific activities - 6 items~Usual activities - 4 items~In addition to the individual subscale scores, a total score can be computed on a scale of 100 (0 = no disability), where pain and functional problems are weighted equally"|Baseline, 4, 8, 12, and 24 weeks|Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points.|||score on a scale||Standard Deviation|Mean
2641387|NCT01746420|Primary|Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects|The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.|Baseline, 4, 8, 12, and 24 weeks|Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points.|||score on a scale||Standard Deviation|Mean
2641388|NCT01746420|Primary|Elbow Pain Assessments (VAS), Treated Subjects|Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).|Baseline, 2, 4, 8, 12, and 24 weeks|Analysis conducted on patients at Baseline, 2, 4, 8, 12, and 24 weeks time points.|||score on a scale||Standard Deviation|Mean
2641389|NCT01746368|Secondary|Satisfaction|"Score on the Client Satisfaction Questionnaire-8 (CSQ-8). The overall score is produced by summing all item responses. For the CSQ-8, scores range from 8 to 32, with higher values indicating higher satisfaction.~Response options differ from item to item, but all are based on a four-point scale.~All items are positively worded; however, the directionality of response options span the spectrum from very negative to very positive; and, the numerical anchors for items are reversed randomly (from high to low or low to high) from item to item to minimize stereotypic response sets. The CSQ-8 has no subscales and reports a single score measuring a single dimension of overall satisfaction."|For participants who received the allocated intervention, up to one month after intervention; for all others, up to 90 days after consenting to the study.||||Scores on a scale||Standard Deviation|Mean
2641390|NCT01746368|Primary|Number of Participants Who Completed an Advance Directive|An advance directive was considered completed upon confirmation of the scanned document in the medical record.|Up to 1 month after intervention|intention to treat (ITT)|||participants|||Number
2641391|NCT01746264|Secondary|Reactive Hyperemia Index (RHI)|The cuff of a sphygmomanometer was placed on the forearm and inflated to 50 mm Hg above the participant's systolic blood pressure for a period of 5 min. The increase in resting brachial blood flow was calculated as the maximum flow recorded in the first 15 seconds after cuff deflation and expressed as a percentage increase from baseline reactive. Higher values are considered normal or improved endothelial function.|baseline, 3 months|Data for one subject could not be included as the data on RHI was lost in the system and could not be retrieved.|||percentage increase in blood flow||Standard Deviation|Mean
2641392|NCT01746264|Secondary|Urine Calcium to Creatinine Ratio|Urine calcium/creatinine ratio (unit mg/g) on random urine sample was calculated by dividing calcium in mg by creatinine in g.|baseline, 3 months||||mg/g||Standard Deviation|Mean
2641393|NCT01746264|Secondary|High Density Lipoprotein (HDL) Cholesterol Levels|Total HDL cholesterol levels were measured by an enzymatic colorimetric assay. The test for high-density lipoprotein cholesterol (HDL-C) is used along with other lipid tests to screen for unhealthy levels of lipids and to determine the risk of developing heart disease. If a subject has a negative risk factor, a desirable HDL level would be >/= 1.55 mmol/L.|baseline, 3 months||||mmol/L||Standard Deviation|Mean
2658563|NCT01597388|Primary|Respiratory Rate||28 Days|The analysis population consisted of all participants who received at least one dose of AZD2014.|||breaths/min||Standard Deviation|Mean
2641394|NCT01746264|Secondary|Low-density Lipoprotein Cholesterol (LDL) Cholesterol Levels|The test for low-density lipoprotein cholesterol is used as part of a lipid profile to predict an individual's risk of developing heart disease. A desirable level is <3.36 mmol/L; borderline high is 3.36 - 4.11 mmol/L; high is >/= 4.14 mmol/L. LDL cholesterol was calculated as: LDL = Total cholesterol - HDL cholesterol - Triglycerides/5.|baseline, 3 months||||mmol/L||Standard Deviation|Mean
2641395|NCT01746264|Secondary|High Sensitivity C-reactive Protein (Hs-CRP)|A high-sensitivity C-reactive protein (hs-CRP) test may be used to help evaluate an individual for risk of cardiovascular disease (CVD). C-reactive protein (CRP) is a protein that increases in the blood with inflammation. Studies have suggested that a persistent low level of inflammation plays a major role in atherosclerosis, the narrowing of blood vessels due to build-up of cholesterol and other lipids, which is often associated with CVD. The hs-CRP test accurately measures low levels of C-reactive protein to identify low but persistent levels of inflammation and thus helps predict a person's risk of developing CVD. hs-CRP was measured using particle-enhanced immunonephelometry.|baseline, 3 months||||nmol/L||Standard Deviation|Mean
2641396|NCT01746264|Secondary|Homeostatic Model Assessment of Insulin Resistance Index (HOMA-IR)|This calculation measures insulin resistance, and requires U.S. standard units. The healthy range is 0.5 to 1.4. Less than 1.0 means the subject is insulin-sensitive, which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance. The HOMA-IR was calculated as: HOMA-IR = fasting serum glucose (mmol/L) x fasting insulin (mU/mL)/22.5.|baseline, 3 months||||index of beta cell function||Standard Deviation|Mean
2641397|NCT01746264|Secondary|Fasting Insulin|Serum insulin was measured using commercial electrochemiluminescence immunoassay kits.|baseline, 3 months||||pmol/L||Standard Deviation|Mean
2641398|NCT01746264|Secondary|Fasting Glucose|Plasma glucose was measured by hexokinase enzymatic assay.|baseline, 3 months||||mmol/L||Standard Deviation|Mean
2641399|NCT01746264|Secondary|Serum Parathyroid Hormone (PTH)|A parathyroid hormone (PTH) blood test measures the level of parathyroid hormone in the blood. This test is used to help identify hyperparathyroidism, to find the cause of abnormal calcium levels, or to check the status of chronic kidney disease. PTH controls calcium and phosphorus levels in the blood. PTH was measured by a two-site chemiluminescent immunometric assay.|baseline, 3 months||||pmol/L||Standard Deviation|Mean
2641400|NCT01746264|Secondary|Calcium Intake Per Day|Calcium intake was measured using the validated Short Calcium Questionnaire (SCQ). This questionnaire is in the form of an spreadsheet, and asks the participant to enter the number of servings per week of various food items and vitamin or mineral supplements. The spreadsheet calculates the daily calcium intake (mg/day) from the data entered.|baseline, 3 months||||mg/day||Standard Deviation|Mean
2641401|NCT01746264|Secondary|International Physical Activity Questionnaire (IPAQ) Short Form Score|The IPAQ short form used asked 7 questions about activities in the last 7 days, covering vigorous physical activities, moderate activities, walking, and sitting, asking for days per week, hours per day or minutes per day. The score is reported in metabolic equivalent (MET)-minutes per week. Possible scores could range from 0 (inactive) to greater than 3000 MET-minutes/week (highly active). The definition of high activity was vigorous intensity activity on at least 3 days achieving a minimum total activity of at least 1500 MET-minutes/week OR 7 days of any combination of walking, moderate-intensity or vigorous-intensity activities achieving a minimum total physical activity of at least 3000 MET-minutes/week. Therefore a score of > 3000 MET-minutes/week was possible.|baseline, 3 months||||MET-minutes per week||Standard Deviation|Mean
2641402|NCT01746264|Secondary|Body Mass Index|Body Mass Index (BMI) is a health index for comparing weight to height. BMI is a person's weight in kilograms (kg) divided by his or her height in meters squared. The body mass index is an indication if a person is at a suitable weight for his height on an approximation of body fat. A body mass index of under 20 is considered to be underweight, while a body mass index between 20 to 25 is considered healthy. A body mass index in the range of 25 to 30 is regarded as overweight. A body mass index over 30 is regarded as obese.|baseline, 3 months||||kg/m^2||Standard Deviation|Mean
2641403|NCT01746264|Secondary|Triglycerides|Total triglyceride levels were measured by an enzymatic colorimetric assay.|baseline, 3 months||||mmol/L||Standard Deviation|Mean
2641404|NCT01746264|Secondary|Total Cholesterol|Total cholesterol levels were measured by an enzymatic colorimetric assay.|baseline, 3 months||||mmol/L||Standard Deviation|Mean
2641405|NCT01746264|Secondary|25-hydroxy Vitamin D (25[OH]D) Levels|25(OH)D was measured using liquid chromatography-tandem mass spectrometry. Total 25(OH)D concentrations of each sample was calculated using internal standard, 25(OH)D_2 and 25(OH)D_3.|baseline, 3 months||||nmol/L||Standard Deviation|Mean
2641406|NCT01746264|Primary|Flow Mediated Dilatation (FMD)|Endothelial function was assessed by FMD, via a high-resolution Doppler ultrasonography examination of the right brachial artery. FMD was calculated as the maximal percentage increase in brachial artery diameter (BAD) from baseline after the release of cuff occlusion.|baseline, 3 months|Data for one subject could not be included as the data on FMD was lost in the system and could not be retrieved.|||percentage increase in BAD||Standard Deviation|Mean
2641407|NCT01746225|Secondary|Changes in Physical Well-being (Change From Day 1 of Cycle 4 to Day 1 of Cycle 6)|Primary quality of life=physical well being; endpoint based on the GLQ 8. The indicator was in Linear Analogue Self-Assessment (LASA) format ranging 0-100 (0=as bad as it can be, 100=as good as it can be).|Assessed from day 1 of cycle 4 through day 1 of cycle 12|Patients who started the maintenance phase of treatment (cycle 4)|||units on a scale||95% Confidence Interval|Mean
2641408|NCT01746225|Secondary|Overall Survival|Time from randomization until death from any cause, or censored at date last known alive|Reported after 18.2 months median follow-up since randomization|Intention to treat population|||months||90% Confidence Interval|Median
2641409|NCT01746225|Secondary|Best Overall Response|Best response according to RECIST 1.1 criteria [assessed by MRI] recorded from the start of treatment across all time points until end of study treatment. Confirmation of partial or complete response by an additional scan was not requested in this trial.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months|Intention to treat population|||Participants|||Count of Participants
2641442|NCT01746095|Secondary|Change From Baseline in MRSA Sputum Density.||Day 8 of treatment period|Modified ITT population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.|||Log10 CFU/mL||Standard Error|Least Squares Mean
2641410|NCT01746225|Secondary|Disease Control: Overall Response of Stable Disease for a Duration of ≥24 Weeks|Overall response of stable disease (or non-CR/non-PD for patients with non-measurable disease) for a duration of ≥24 weeks, or better (i.e., partial or complete response) according to RECIST criteria [Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.]|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months|Intention to treat population|||Participants|||Count of Participants
2641411|NCT01746225|Secondary|Feasibility of Treatment: Number of Participants Completed Treatment According to the Protocol for at Least 24 Weeks|Whether or not the patient completed treatment according to the protocol for at least 24 weeks. Patients who progressed within 24 weeks were considered as not completing.|Baseline to 24 weeks follow-up|Intention to treat population|||Participants|||Count of Participants
2641412|NCT01746225|Primary|Progression-free Survival|Time from randomization until objective disease progression [progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions] or death, whichever occurs first. For patients without progression, follow-up was censored at the date of last disease assessment without progression, unless death occurred within a short period of time (12 weeks) following the date last known progression-free, in which case the death was counted as a PFS event.|Reported after 18.2 months median follow-up since randomization|Intention-to-treat population|||months||90% Confidence Interval|Median
2641413|NCT01746173|Secondary|Induction Response|Induction response is the defined as the proportion of patients who achieve complete remission (CR) or partial remission (PR) during 6 cycles of induction therapy. Reponse was assessed was using a combination of CT scans and PET scans. Partial and complete response were categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007). Given the cycle length of 3 weeks, induction duration per protocol was 18 weeks.|Disease was re-staged at cycles 3 and 6 during induction. Median duration of induction therapy in this study cohort was 6 cycles/18 weeks (range 2-6 cycles).||||proportion of patients||90% Confidence Interval|Number
2641414|NCT01746173|Primary|24-month Progression-Free Survival Rate|24-month progression-free survival rate is defined as the proportion of patients remaining alive and progression-free at 24 months from start of induction therapy. Disease progression was assessed using a combination of CT scans and PET scans. Progression was categorized according to standard lymphoma response criteria, specifically the Revised Response Criteria (Cheson 2007).|Disease was re-staged at cycles 3 and 6 during induction, at day 100 post-ASCT, and in long-term follow-up at months 12, 18, 24 and 36. All patients were evaluable up to month 24.|The analysis dataset is comprised all enrolled patients.|||proportion of patients||90% Confidence Interval|Number
2641415|NCT01746108|Secondary|Concentrations of Antibodies Against Protein D (PD) in the Healthy Unprimed Group.|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations < 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2641416|NCT01746108|Secondary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the Healthy Un-primed Group.|"Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. When number of subjects analysed = 1, Lower limit and Upper Limit values were entered as equal to the Geometric mean value. 999999.9 was used as placeholder when Upper Limit value was greater than 1.0E8."|One month after Dose 1 (At Month 1) and/or one month after Dose 2 (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2641417|NCT01746108|Secondary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the Healthy Un-primed Group.|"Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.~Antibody concentrations < 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation."|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2641418|NCT01746108|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of study subjects|From Dose 1 at Month 0 up to study end at Month 1 for primed subjects and at Month 3 for unprimed subjects.|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2641443|NCT01746095|Primary|Change From Baseline in MRSA Sputum Density.|Change from Baseline at Day 29 of the dosing period (start of AeroVanc/Placebo administration is considered Day 1 of the dosing period) in the number of MRSA colony forming units (CFU) in sputum culture.|Day 29 of treatment period|Modified ITT population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.|||Log10 CFU/mL||Standard Error|Least Squares Mean
2641419|NCT01746108|Secondary|Number of Subjects With Unsolicited AEs.|An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 31-day (Days 0-30) post- vaccination period|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2641420|NCT01746108|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 2 for Subjects Aged Between 5 to 17 Years.|General AEs = headache, fatigue, gastrointestinal symptoms (gastro symp) (nausea, vomiting, diarrhoea and/or abdominal pain) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: headache, fatigue and gastrointestinal symptoms = symptoms that prevented normal activity; Fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 2|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2641421|NCT01746108|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 1 for Subjects Aged Between 5 to 17 Years.|General AEs = headache, fatigue, gastrointestinal symptoms (gastro symp) (nausea, vomiting, diarrhoea and/or abdominal pain) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: headache, fatigue and gastrointestinal symptoms = symptoms that prevented normal activity; Fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 1|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2641422|NCT01746108|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 2 for Subjects Aged Between 2 to 4 Years.|General AEs = drowsiness, irritability, loss of appetite (loss of appet) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity; irritability = crying that could not be comforted/ prevented normal activity; loss of appetite = not eating at all; fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 2|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2641423|NCT01746108|Secondary|Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs) After Dose 1 for Subjects Aged Between 2 to 4 Years.|General AEs = drowsiness, irritability, loss of appetite (loss of appet) and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity; irritability = crying that could not be comforted/ prevented normal activity; loss of appetite = not eating at all; fever > 39.5°C. Related = symptom assessed by the investigator as related to the vaccination. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 1|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2641424|NCT01746108|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 2 for Subjects Aged Between 5 to 17 Years.|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest. Prevented normal every day activities. Grade 3 redness/swelling = redness/swelling above 50 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 2|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2641425|NCT01746108|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 1 for Subjects Aged Between 5 to 17 Years.|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain =Significant pain at rest. Prevented normal every day activities. Grade 3 redness/swelling = redness/swelling above 50 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 1|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2641426|NCT01746108|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 2 for Subjects Aged Between 2 to 4 Years.|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 2|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2641427|NCT01746108|Secondary|Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs) After Dose 1 for Subjects Aged Between 2 to 4 Years.|Solicited local AEs assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre. Primed subjects received one dose and Unprimed subjects received two doses.|During the 4-day (Days 0-3) after dose 1|The Total Vaccinated cohort included all vaccinated subjects.|||Subjects|||Number
2641428|NCT01746108|Primary|Concentrations of Antibodies Against Protein D (PD) in the At Risk Unprimed Group.|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations < 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2641429|NCT01746108|Primary|Concentrations of Antibodies Against Protein D (PD) in the At Risk Primed Group.|Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations < 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.|One month after Dose 1 (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2641430|NCT01746108|Primary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the At Risk Un-primed Group.|"Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was~≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation."|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2641431|NCT01746108|Primary|Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes in the At Risk Primed Group.|"Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was~≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation."|One month after Dose 1 (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2641432|NCT01746108|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the At Risk Un-primed Group.|"Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A,~-19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.~Antibody concentrations < 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation."|One month after Dose 1 (At Month 1) and one month after Dose 2 (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2641433|NCT01746108|Primary|Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes in the At Risk Primed Group.|"Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.~Antibody concentrations < 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation."|One month after Dose 1 (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for at least one blood sample taken after vaccination.|||μg/mL||95% Confidence Interval|Geometric Mean
2641434|NCT01746095|Secondary|Change From Baseline in Blood Neutrophils||Day 29 of the dosing period|Modified ITT population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.|||10^9 cells/L||Standard Error|Least Squares Mean
2641435|NCT01746095|Secondary|Change From Baseline in High Sensitivity CRP||Day 29 of the dosing period|Modified ITT population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.|||mg/dL||Standard Error|Least Squares Mean
2641436|NCT01746095|Secondary|Time From Start of Dosing to Exacerbation of Signs/Symptoms (Fuchs Criteria).||Entire study: Day 1 of treatment period through 8 week post-treatment follow up visit|Modified ITT population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.|||days||95% Confidence Interval|Median
2641437|NCT01746095|Secondary|Time From Start of Dosing to First Administration of Other Antimicrobial Medications (Oral, Intravenous and/or Inhaled) Due to Respiratory Symptoms.||Entire study: Day 1 of treatment period through 8 week post-treatment follow up visit|Modified ITT population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.|||days||95% Confidence Interval|Median
2641438|NCT01746095|Secondary|Change From Baseline in Cystic Fibrosis Respiratory Symptom Diary (CFRSD-CRISS) Scores|Change from Baseline in Cystic Fibrosis Respiratory Symptom Diary (CFRSD) Chronic Respiratory Infection Symptom Scores (CRISS). The minimum score is 0 and the maximum is 100, where a higher score means a worse outcome.|Day 29 of treatment period|Modified ITT population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.|||score on a scale||Standard Error|Least Squares Mean
2641439|NCT01746095|Secondary|Change From Baseline in FVC|Absolute change from baseline in FVC percent predicted|Day 29 of treatment period|Modified ITT population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.|||percentage of predicted FVC||Standard Error|Least Squares Mean
2641440|NCT01746095|Secondary|Change From Baseline in FEV1|Absolute change from baseline in FEV1 percent predicted|Day 29 of treatment period|Modified ITT population, which included all randomized patients who received any amount of study drug and had at least one scheduled post baseline measurement.|||percentage of predicted FEV1||Standard Error|Least Squares Mean
2641444|NCT01746043|Primary|Proportion of Patients Under Each Treatment Arm Who Experienced a Mean Symptom Increase of 2 Units or More From Baseline to 6 Weeks.|Mean symptom score defined as the mean of MDASI fatigue, pain, disturbed sleep, lack of appetite, and drowsiness scores|Baseline, 6 weeks|Of the 21 randomized patients , 19 (90% were evaluable for the primary efficacy analysis).|||Participants|||Count of Participants
2641445|NCT01746017|Secondary|Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)]|LS mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.|Baseline (predose for Part A and Day -1 time-matched for Part B), 6 hours postdose|All participants who received at least 1 dose of study drug with both baseline and 6 hours postdose C-peptide AUEC(0-6) values. Participants were analyzed based on the treatment they received.|||picomoles*hour/Liter (pmol*h/L)||Standard Error|Least Squares Mean
2641446|NCT01746017|Secondary|Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)]|Least Squares (LS) mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.|Baseline (predose for Part A and Day -1 time-matched for Part B), 24 hours postdose|All participants who received at least 1 dose of study drug with both baseline and 24 hours postdose glucose AUEC(0-24) values. Participants were analyzed based on the treatment they received.|||millimoles*hour/Liter (mmol*h/L)||Standard Error|Least Squares Mean
2641447|NCT01746017|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470||Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 48, 96 and 192 hours postdose|All enrolled participants who received at least 1 dose of study drug and had sufficient pharmacokinetics data to calculate Cmax. Participants were analyzed based on the treatment they received.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2641448|NCT01746017|Secondary|Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)]||Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18, 24, 48, 96 and 192 hours postdose|All enrolled participants who received at least 1 dose of study drug and had sufficient pharmacokinetics data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.|||nanograms*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2641449|NCT01746017|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is located in the Reported Adverse Events module.|Baseline to study completion up to 33 days|All enrolled participants who received at least 1 dose of study drug. Participants were analyzed based on the treatment they received.|||Participants|||Count of Participants
2641450|NCT01745952|Other Pre-specified|Adverse Event Rate||during the 9 months of the study||||participants|||Number
2641451|NCT01745952|Other Pre-specified|Drop Out-rate|exclusion by investigator was due to necessity to change drug regimen due to toxicity|during the 9 months of the study|for this analysis, all patients randomised were included; this includes one patient in the second arm that was not included in any of the other outcome measures, due to lack of reliable outcome parameters|||participants|||Number
2641452|NCT01745952|Other Pre-specified|Questionnaires: Quality of Life in Epilepsy (QOLIE-31), Global Impression of Change-scales, Visual Analogue Scale, Columbia Suicide Severity Rating Scale|"Quality of life in epilepsy (QOLIE-31): self-report (if cognitive faculties allowed) questionnaire of emotional well-being, social functioning, energy/ fatigue, cognitive functioning, seizure worry, medication effects & overall quality of life. Range 0-100, with higher numbers indicating better quality of life.~Global impression of change-scales (score 1-7, with 4 no change and lower/higher numbers implying grade of improvement/worsening) and Visual analogue scale (0-10: no problem to horrible): self-report or parent report about effect of treatment~Columbia Suicide Severity Rating Scale (CSSR): structured interview about suicidal risk~change in QOLIE scores considered better/worse are based on cut-off reported in DOI 10.1016/j.yebeh.2011.12.023 For global impression of change, the scoring was <4, 4 or >4."|before the first treatment of each session and at the last evaluation visit|* Self-reporting questionnaires could only be filled in by 7 participants For global impression of change scales, the score reached by consensus between the patient and caregiver(s) was used if patient was unable to fill in questionaires: for the three arms, we thus have 7/8/6 scores for each arm respectively|||participants|||Number
2641453|NCT01745952|Other Pre-specified|Difference in Seizure Reduction Using Different Coil Types|any difference between the four conditions (baseline/ figure-of-eight treatment/ round coil treatment/ sham treatment) based in negative binomial model for count data|9 months|averaged weekly seizure count per condition is given for all patients combined|||number of seizures per week||95% Confidence Interval|Mean
2641454|NCT01745952|Other Pre-specified|Alteration of Brain Activation as Measured by 18-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) on Individual Patient Level|Alterations were assessed by visual inspection of PET scans generated by subtracting the baseline individual PET scan from each of the follow-up scans. The subtraction PET scans were overlayed on the anatomical MRI of the patient and the focus of stimulation determined and an sphere with a 1cm radius around this point was analysed.|within one week after the last treatment day of each session|"patients of whom seizure journals were incomplete also included (one participant who went through all 3 trials and one patient of whom journals were not available from the sham session, that was reported by the patient as ineffective)"|||participants|||Number
2641455|NCT01745952|Secondary|Percentage of Seizure Reduction After Active rTMS Treatment Compared With Placebo Treatment|Seizure frequency was recorded in patient diaries and reviewed with the neurologist/epileptologist (outcomes assessor) at visits 12 weeks (+/- 1 week) after each intervention. The average weekly seizure rate was calculated and compared to baseline frequency over all participants.|week 12 after each treatment|baseline weekly seizure frequency over all participants was 24.8 (95% confidence interval 8.2-76.1)|||seizures/week||95% Confidence Interval|Mean
2641456|NCT01745952|Primary|50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment|Number of participants achieving a 50% or greater reduction in seizure frequency from baseline|week 12 after each intervention||||participants|Participants||Number
2641457|NCT01745913|Secondary|Severity of Opportunistic Infections||estimation of 24 months to obtain infection data on all subjects|Data were not collected||||||
2641458|NCT01745913|Secondary|Incidence of Acute and Chronic GVHD||estimation of 24 months to obtain GVHD data on all subjects|Data were not collected||||||
2641462|NCT01745913|Primary|Rate of Neutrophil Engraftment After Combined Haplo-identical Cord With That of Umbilical Cord Blood Transplantation.|No patients completed this study and are therefore inevaluable. Subject data not evaluable for the outcome measure time frame. Subject data only evaluable up to month 3.|estimation of 24 months to determine engraftment rates for all subjects|Data not collected. Patients died.||||||
2641463|NCT01745848|Secondary|Absolute Change From Baseline of Measurements of Brachial Artery Flow Mediated Dilation|Participants had flow mediated dilation of the brachial artery measured at the baseline visit and at the follow-up visit after receiving 30 days of roflumilast 500 mcg daily. An ultrasound probe was placed over the brachial artery and the brachial artery diameter was measured in real time. A blood pressure cuff positioned below the elbow was then inflated to 50 mmHg above systolic pressure for five minutes. After five minutes of occlusion, the blood pressure cuff was released and the brachial artery diameter was again measured in real time. The amount of dilation expressed as the absolute change, in millimeters, from baseline diameter was quantified using the ultrasound images obtained 60 seconds after cuff release.|30 days - measured at baseline and 30 days|Data were analyzed for the 20 participants completing baseline and follow-up visits after one month on study drug.|||millimeters||Standard Deviation|Mean
2641464|NCT01745848|Primary|Change From Baseline of Systemic Markers of Bone Metabolism (C-terminal Peptide of Type 1 Collagen (CTx) and Amino-terminal Propeptide of Type-1 Procollagen (P1NP))|Serum samples were obtained at baseline and after participants took a once daily, 500 mcg roflumilast dose for 30 days. Samples were obtained in the semi-fasting state, processed, and stored for batch analysis at the end of the study. C-terminal peptide of type 1 collagen (CTx), a marker of bone resorption, was analyzed using a commercially available immunoassay (Roche Elecsys 2010 analyzer, Roche Diagnostics, Manheim, Germany). Serum amino-terminal propeptide of type-1 procollagen (P1NP) was measured by ELISA (MyBioSource, San Diego, CA). All assays were performed according to the manufacturers' instructions.|30 days - measurements at baseline and 30 days|Data were analyzed for the 20 participants completing baseline and follow-up visits after one month on study drug.|||ng/mL||Standard Deviation|Mean
2641465|NCT01745393|Secondary|Parent-reported Cotinine-verified 7-day Point Prevalence Abstinence|When a participant reports smoking abstinence, we will bioverify their smoking status.|up to 12 months||||Participants|||Count of Participants
2641466|NCT01745393|Primary|Parent-reported Second-hand Smoke Exposure in Cigarettes Per Day From All Sources|Parental report of cigarettes child is exposed to each day in the home and car by all sources during the 7 days prior to assessment. We anticipate the CQI+BC treatment group will report greater reductions in second-hand smoke exposure over time than the CQI+A control group.|up to 12 months||||cigarettes exposed per day||Standard Deviation|Mean
2641467|NCT01745393|Primary|Child Urine Cotinine|Child urine cotinine is a biomarker for assessing second-hand smoke exposure. We anticipate the CQI+BC treatment group will experience a greater reduction in child urine cotinine over time than the CQI+A control group.|up to 12 months|The fewer number of units analyzed compared to participants analyzed relates to completion of telephone assessments for all participants, but inability to collect 5 urine samples in the Behavioral Counseling group and 2 urine samples in the Attention Control group at the post-phone assessment urine pickup at participants' homes.|||log transformed ng/mL|urine cotinine samples|Standard Deviation|Mean
2641468|NCT01745380|Other Pre-specified|Number of Participants Who Received Three Sprays and Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.|A participant will receive two sprays and Study Dental Procedure will begin. If the participant does not have sufficient anesthesia a third sprays will be given. If after the third spray, the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic. This outcome analyzes just the participants who received the third spray and whether or not they completed the Study Dental Procedure without need for rescue by injection of local anesthesia.|at 25 minutes, +3 minute window|This analysis is only of the participants who received 3 sprays. It does not include participants who only received 2 sprays.|||participants|||Number
2641469|NCT01745380|Secondary|The Profile Over Time of Diastolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
2641470|NCT01745380|Secondary|The Profile Over Time of Systolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
2641471|NCT01745380|Secondary|Alcohol Sniff Test|The change from screening in the the distance from the nose (in centimeters) that a patient is able to detect the smell of alcohol on a cotton ball.|administered at approximately 24 hours after drug administration||||cm||Standard Deviation|Mean
2641472|NCT01745380|Secondary|The Profile Over Time of Heart Rate||from baseline to 120 minutes following drug administration||||beats per minute||Standard Deviation|Mean
2641473|NCT01745380|Secondary|Maximum Change From Baseline in Diastolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
2641474|NCT01745380|Secondary|Maximum Change From Baseline in Systolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
2641475|NCT01745380|Secondary|Maximum Change From Baseline in Heart Rate||from baseline to 120 minutes following drug administration||||bpm||Standard Deviation|Mean
2641476|NCT01745380|Secondary|Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and/or to a Value Lower Than 50 mm Hg||at any time within 120 minutes following study drug administration||||participants|||Number
2641477|NCT01745380|Secondary|Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Higher Than 105 mm Hg||at any time within 120 minutes following study drug administration||||participants|||Number
2641478|NCT01745380|Secondary|Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Lower Than 90 mm Hg||at any time within 120 minutes following study drug administration||||participants|||Number
2641479|NCT01745380|Secondary|Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and/or to a Value Higher Than 160 mm Hg||at any time within 120 minutes following drug administration||||participants|||Number
2641480|NCT01745380|Secondary|Number of Participants With a Heart Rate Lower Than 50 Bpm||at any time within 120 minutes following drug administration||||participants|||Number
2641482|NCT01745380|Secondary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic by Age Group (≤50 and >50 Years)|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome. This outcome is broken down by age group, 1) less than 50 years of age and 2) 50 years of age and older.|at 15 minutes (+3 minute window) or 25 minutes (+3 minute window) if third intranasal spray is used|Participants were only analyzed in their corresponding age group.|||percentage of participants|||Number
2641483|NCT01745380|Primary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.|at 15 minutes, +3 minute window||||participants|||Number
2641484|NCT01745146|Primary|Post-Treatment Response Rate From Baseline on Anger Measures - Participant Report|"Participant report only. The State-Trait Anger Expression Inventory-Revised Trait Anger Scale (STAXI-2 TA) measures how often angry feelings are experienced and the Anger Expression-Out (STAXI-2 AX-O) Scale addresses the expression of anger toward other persons or objects in the environment. The Brief Anger-Aggression Questionnaire (BAAQ) is a 6-item self-report scale that measures frequency of acting-out symptoms of anger. Overall treatment response is defined as ≥ 1 standard deviation change in the direction of improvement from pre- to 10 wk post-treatment on any 1 of the three anger scales used. Analysis first done by including participants who did not complete the assessment as non-responders (labeled as missing outcomes included or MOI). Analysis done a second time only using participants who completed the assessment (labeled as missing outcomes removed or MOR)."|Baseline, 10 weeks (post-treatment)|Missing outcomes originally treated as non-Responders (Protocol Specified) and then taken out of data set.|||percentage of participants||95% Confidence Interval|Number
2641485|NCT01745133|Primary|Physician Global Assessement|"Percentage of participants with clear or almost clear skin on the PGA scale. 0 = clear~= almost clear~= mild~= moderate~= severe"|10 weeks||||percentage of patients|||Number
2641486|NCT01745120|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was any AE, occurring at any dose and regardless of causality that: results in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect.|From signing of informed consent to 24 months after the drug product infusion|ITT population included all participants who initiated any study procedures, beginning with mobilization by G-CSF with or without plerixafor.|||Participants|||Count of Participants
2641487|NCT01745120|Secondary|Number of Participants With Integration Site Analysis (ISA) With >30% Clonal Contribution|Linear amplification-mediated polymerase chain reaction (LAM-PCR) coupled with next generation sequencing and subsequent (semi-) automated data mining allowed high-throughput analysis of vector integration site (IS) in blood cells from treated participants at multiple time points. ISs detected in peripheral blood cells at early time points generally were due to the expansion of transduced short-term progenitor stem cell clones, and gradually shift to include sites detected due to expansion of transduced long-term stem cell clones. An efficient transduction procedure was anticipated to give rise to a polyclonal population in the participant, reflected by the detection of multiple IS. Additionally, ISA allowed monitoring of the relative contribution of individual clones over time. Number of participants who had IS that contributed to >=30% of the total clones at any time was used as a first step to investigating whether clonal dominance was achieved.|From time of drug product infusion up to 24 months|TP included all participants in the ITT population (participants who initiated any study procedures, beginning with mobilization by G-CSF with or without plerixafor) who underwent LentiGlobin BB305 Drug Product infusion.|||Participants|||Count of Participants
2641488|NCT01745120|Secondary|Percentage of Participants Detected With Replication-competent Lentivirus (RCL)|Blood samples were analyzed for detection of RCL using RCL co-culture assay.|From time of drug product infusion up to 24 months|TP included all participants in the ITT population (participants who initiated any study procedures, beginning with mobilization by G-CSF with or without plerixafor) who underwent LentiGlobin BB305 Drug Product infusion.|||Percentage of participants|||Number
2641489|NCT01745120|Secondary|Overall Survival|Overall survival was defined as time from date of LentiGlobin BB305 Drug Product infusion (Day 1) to date of death. Overall survival was censored at the date of last visit if the participant was still alive. Percentage of participants who survived throughout the study were reported.|From time of drug product infusion up to 24 months|ITT population included all participants who initiated any study procedures, beginning with mobilization by G-CSF with or without plerixafor.|||Percentage of participants|||Number
2641490|NCT01745120|Secondary|Transplant-related Mortality|Transplant-related mortality was determined by the investigator (any deaths considered related to the transplant.)|Through 100 and 365 days post-LentiGlobin BB305 Drug Product infusion|ITT population included all participants who initiated any study procedures, beginning with mobilization by G-CSF with or without plerixafor.|||Participants|||Count of Participants
2641491|NCT01745120|Secondary|Time to Platelet Engraftment|Time to platelet engraftment was defined as achieving of first 3 consecutive platelet values >= 20 × 10^9/L obtained on different days after a post-transplant value of < 20 × 10^9/L, while no platelet transfusions administered for 7 days immediately preceding and during the evaluation period. The day of platelet engraftment is the first day of the 3 consecutive measurements, where Day 1 is the day of drug product infusion.|From time of drug product infusion up to 24 months|TP included all participants in the ITT population (participants who initiated any study procedures, beginning with mobilization by G-CSF with or without plerixafor) who underwent LentiGlobin BB305 Drug Product infusion.|||Days||Full Range|Median
2641523|NCT01745055|Secondary|Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to 12 Hours (Ae[0-12]) for CP-690,550||0 (pre-dose) through 12 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||milligram||Standard Deviation|Mean
2641492|NCT01745120|Secondary|Number of Participants With Successful Platelet Engraftment|Platelet engraftment was defined as achieving 3 consecutive platelet values >= 20 × 10^9/L on different days after a post-transplant value of < 20 × 10^9/L, while no platelet transfusions administered for 7 days immediately preceding and during the evaluation period.|From time of drug product infusion up to 24 months|TP included all participants in the ITT population (participants who initiated any study procedures, beginning with mobilization by G-CSF with or without plerixafor) who underwent LentiGlobin BB305 Drug Product infusion.|||Participants|||Count of Participants
2641493|NCT01745120|Secondary|Time to Neutrophil Engraftment|Time to neutrophil engraftment was defined as the time to the first of 3 consecutive absolute neutrophil count (ANC) >= 0.5 × 10^9/L obtained on different days after a post-transplant value of < 0.5 × 10^9/L. The Day of neutrophil engraftment is the first day of the 3 consecutive measurements, where Day 1 is the day of drug product infusion.|From time of drug product infusion up to 24 months|TP included all participants in the ITT population who underwent LentiGlobin BB305 Drug Product infusion.|||Days||Full Range|Median
2641494|NCT01745120|Secondary|Number of Participants With Successful Neutrophil Engraftment|Neutrophil engraftment was defined as achieving 3 consecutive absolute neutrophil count (ANC) >= 0.5 × 10^9/L on different days after a post-transplant value of < 0.5 × 10^9/L within 42 days after drug product infusion.|From time of drug product infusion up to 24 months|TP included all participants in the ITT population (participants who initiated any study procedures, beginning with mobilization by G-CSF with or without plerixafor) who underwent LentiGlobin BB305 Drug Product infusion.|||Participants|||Count of Participants
2641495|NCT01745120|Secondary|Weighted Average Nadir Hemoglobin (Hb)|Weighted average Hb nadir was defined as an average area under the curve where the Hb closest but within 3 days prior to a transfusion is used as the Hb nadir. If there is a period of more than 60 days without a pRBC transfusion, all Hb records between Day 61 and day of last visit or next transfusion (inclusive) were also considered as nadirs. The weighted average nadir Hb during the period of Month 6 to Month 24 was compared to the weighted average nadir Hb during the 2 years prior to enrollment.|Baseline, Month 6 to Month 24|TP included all participants in the ITT population (participants who initiated any study procedures, beginning with mobilization by G-CSF with or without plerixafor) who underwent LentiGlobin BB305 Drug Product infusion.|||Grams per deciliter (g/dL)||Standard Deviation|Mean
2641496|NCT01745120|Secondary|Percentage Change From Baseline in Average Annual Packed Red Blood Cells (pRBC) Transfusion Volume at Month 24|The annualized volume of pRBC transfusions over the 2 year period prior to drug product infusion was compared to the annualized volume of pRBC transfusions in the Month 6 to Month 24 period post drug product Infusion and the percentage change from baseline was reported.|Baseline, Month 24|TP included all participants in the ITT population (participants who initiated any study procedures, beginning with mobilization by G-CSF with or without plerixafor) who underwent LentiGlobin BB305 Drug Product infusion.|||Percentage of pRBC transfusion volume||Full Range|Median
2641497|NCT01745120|Secondary|Percentage Change From Baseline in Annualized Number of Packed Red Blood Cells (pRBC) Transfusions at Month 24|The annualized number of pRBC transfusions over the 2 year period prior to drug product infusion was compared to the annualized number of pRBC transfusions during the Month 6 to Month 24 period post drug product infusion and the percentage change was reported.|Baseline, Month 24|TP included all participants in the ITT population (participants who initiated any study procedures, beginning with mobilization by G-CSF with or without plerixafor) who underwent LentiGlobin BB305 Drug Product infusion.|||Percentage of annualized transfusions||Full Range|Median
2641498|NCT01745120|Secondary|Weighted Average Hemoglobin (Hb) During Period of Transfusion Independence (TI)|The weighted average Hb is an average area under the curve during the period of TI, from the start of TI when the Hb is first >= 9 g/dL with no transfusions in the preceding 60 days to the last available Hb at which the TI criteria are still met. TI was defined as a weighted average Hb >= 9 g/dL without any pRBC transfusions for a continuous period of >= 12 months at any time during the study after LentiGlobin BB305 Drug Product infusion. Weighted average Hb during the period of TI was reported.|From time of drug product infusion up to 24 months|"TP included all participants in the ITT population (participants who initiated any study procedures, beginning with mobilization by G-CSF with or without plerixafor) who underwent LentiGlobin BB305 Drug Product infusion. Here, number of participants analyzed refers to the number of participants who reported TI."|||Grams per deciliter (g/dL)||Standard Deviation|Mean
2641499|NCT01745120|Secondary|Time From LentiGlobin BB305 Drug Product Infusion to Achieving Transfusion Independence (TI)|TI was defined as a weighted average Hb >= 9 g/dL without any pRBC transfusions for a continuous period of >= 12 months at any time during the study after LentiGlobin BB305 Drug Product infusion. Time from drug product infusion to initial achievement of TI was calculated as the time from drug product infusion to the first Hb at which a participant can be declared as TI.|From time of drug product infusion up to 24 months|"TP included all participants in the ITT population (participants who initiated any study procedures, beginning with mobilization by G-CSF with or without plerixafor) who underwent LentiGlobin BB305 Drug Product infusion. Here, number of participants analyzed refers to the number of participants who reported TI."|||Months||Full Range|Median
2641500|NCT01745120|Secondary|Time From LentiGlobin BB305 Drug Product Infusion to Last pRBC Transfusion Prior to Achieving Transfusion Independence (TI)|TI was defined as a weighted average Hb >= 9 g/dL without any pRBC transfusions for a continuous period of >= 12 months at any time during the study after LentiGlobin BB305 Drug Product infusion. Time From LentiGlobin BB305 Drug Product Infusion to last pRBC transfusion prior to achieving TI was reported.|From time of drug product infusion up to 24 months|"TP included all participants in the ITT population (participants who initiated any study procedures, beginning with mobilization by G-CSF with or without plerixafor) who underwent LentiGlobin BB305 Drug Product infusion. Here, number of participants analyzed refers to the number of participants who reported TI."|||Months||Full Range|Median
2641519|NCT01745094|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|TEAEs were defined as AEs observed after the first administration of the study drugs for the treatment period. The investigator assessed the severity of AEs, including abnormal clinical laboratory values, Electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affected normal daily activities; Severe: Inability to perform daily activities. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator.|From first dose of study drug up to weeks 16|SAF|||Participants|||Count of Participants
2641501|NCT01745120|Secondary|Duration of Transfusion Independence (TI)|TI was defined as a weighted average Hb >= 9 g/dL without any pRBC transfusions for a continuous period of >= 12 months at any time during the study after LentiGlobin BB305 Drug Product infusion. Time period of TI will start when participants achieve a Hb >= 9 g/dL with no transfusions in the preceding 60 days. Duration of TI was calculated as the time from the start of TI (i.e. first Hb >= 9 g/dL with no transfusions in the preceding 60 days) up to the last available Hb at which the TI criteria are still met.|From time of drug product infusion up to 24 months|"TP included all participants in the ITT population (participants who initiated any study procedures, beginning with mobilization by G-CSF with or without plerixafor) who underwent LentiGlobin BB305 Drug Product infusion. Here, number of participants analyzed refers to the number of participants who reported TI."|||Months||Full Range|Median
2641502|NCT01745120|Secondary|Percentage of Participants Who Achieved Transfusion Independence (TI) at Month 18 and Month 24|TI was defined as a weighted average Hb >= 9 g/dL without any pRBC transfusions for a continuous period of >= 12 months at any time during the study after LentiGlobin BB305 Drug Product infusion.|Month 18, Month 24|TP included all participants in the ITT population (participants who initiated any study procedures, beginning with mobilization by G-CSF with or without plerixafor) who underwent LentiGlobin BB305 Drug Product infusion.|||Percentage of participants|||Number
2641503|NCT01745120|Primary|Percentage of Participants Who Achieved Transfusion Independence (TI)|TI was defined as a weighted average hemoglobin (Hb) >= 9 g/dL without any packed red blood cells (pRBC) transfusions for a continuous period of >=12 months at any time during the study after LentiGlobin BB305 Drug Product infusion. Percentage of participants who achieved TI from time of drug product infusion up to 24 months was reported.|From time of drug product infusion up to 24 months|TP included all participants in the ITT population (participants who initiated any study procedures, beginning with mobilization by G-CSF with or without plerixafor) who underwent LentiGlobin BB305 Drug Product infusion.|||Percentage of participants|||Number
2641504|NCT01745120|Primary|Percentage of Participants With Sustained Production of >=2.0 Grams Per Deciliter (g/dL) of Hemoglobin A (HbA) Containing βA-T87Q-globin (HbAT87Q) for the Six Months Between Month 18 and Month 24|Percentage of participants with sustained production of >=2.0 grams per deciliter (g/dL) of hemoglobin A (HbA) containing βA-T87Q-globin (HbAT87Q) for 6 months (Month 18 to Month 24) was reported.|Month 18 to Month 24|Transplant Population (TP) included all participants in the ITT population (participants who initiated any study procedures, beginning with mobilization by G-CSF with or without plerixafor) who underwent LentiGlobin BB305 Drug Product infusion.|||Percentage of participants|||Number
2641505|NCT01745094|Secondary|Change From Baseline in Postvoid Residual (PVR) Volume|Measurement of PVR volume was made using either ultrasonography or urethral catheterization, provided that the same method was used for the same participant throughout the study.|Baseline and week 4, 8, 12, 16|SAF|||mL||Standard Deviation|Mean
2641506|NCT01745094|Secondary|Change From Baseline in the Number of Nocturia Episodes Per Night|"Participants completed the patient diary (paper document) for 3 days immediately before each visit. A nocturia episode was defined as waking at night 1 or more times to void. Night time was defined as the period between bedtime and the wake-up time the following day (micturitions at the same time as the wake-up time were excluded). The mean number of nocturia episodes per night was calculated by taking the sum of nocturia episodes in the patient diary where the variable urinated was indicated during the night time, divided by the number of nights. Only participants who had a nocturia episode at baseline was included in the analysis."|Baseline and week 4, 8, 12, 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||nocturia episodes||Standard Deviation|Mean
2641507|NCT01745094|Secondary|Change From Baseline in the Volume Voided Per Micturition|"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean volume per micturition was calculated by taking the sum of the urinary volumes where the volume voided was > 0 and where urinary incontinence was not indicated in the patient diary, divided by the number of micturitions where the volume voided was > 0 and where urinary incontinence was not indicated. Only participants who had volume voided was > 0 at baseline was included in the analysis."|Baseline and week 8, 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||mL||Standard Deviation|Mean
2641508|NCT01745094|Secondary|Change From Baseline in the Number of Urge Incontinence Episodes Per 24 Hours|"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urge incontinence episode was defined as any episode when both urgency and incontinence occurred concurrently. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency and urinary incontinence' were indicated, divided by the number of days on which episodes were recorded. Only participants who had an urge incontinence episode at baseline was included in the analysis."|Baseline and week 4, 8, 12, 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||urge incontinence episodes||Standard Deviation|Mean
2641509|NCT01745094|Secondary|Number for Participants Who Achieved Normalization of the Number of Incontinence Episodes Per 24 Hours|Normalization for the mean number of incontinence episodes per 24 hours was defined as no incontinence episode per 24 hours.|Week 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||Participants|||Count of Participants
2641520|NCT01745055|Secondary|Renal Clearance (CL R) for Methotrexate (MTX)||0 (pre-dose) through 24 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||L/hr||Standard Deviation|Mean
2658564|NCT01597388|Primary|Sitting Systolic Blood Pressure||28 Days|The analysis population consisted of all participants who received at least one dose of AZD2014.|||mmHg||Standard Deviation|Mean
2641510|NCT01745094|Secondary|Change From Baseline in the Number of Incontinence Episodes Per 24 Hours|"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinary incontinence' was indicated, divided by the number of days on which episodes were recorded. Only participants who had an incontinence episode at baseline was included in the analysis."|Baseline and week 4, 8, 12, 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||incontinence episodes||Standard Deviation|Mean
2641511|NCT01745094|Secondary|Number for Participants Who Achieved Normalization of the Number of Urgency Episodes Per 24 Hours|Normalization for the mean number of urgency episodes per 24 hours was defined as no urgency episode per 24 hours.|Week 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||Participants|||Count of Participants
2641512|NCT01745094|Secondary|Change From Baseline in the Number of Urgency Episodes Per 24 Hours|"Participants completed the patient diary (paper document) for 3 days immediately before each visit. An urgency episode was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urgency was indicated, divided by the number of days on which episodes were recorded. Only participants who had an urgency episode at baseline was included in the analysis."|Baseline and week 4, 8, 12, 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||urgency episodes||Standard Deviation|Mean
2641513|NCT01745094|Secondary|Number for Participants Who Achieved Normalization of the Number of Micturitions Per 24 Hours|Normalization for the mean number of micturitions per 24 hours was defined as < 8 micturitions per 24 hours.|Week 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||Participants|||Count of Participants
2641514|NCT01745094|Secondary|Change From Baseline in the Number of Micturitions Per 24 Hours|"Participants completed the patient diary (paper document) for 3 days immediately before each visit. The mean number of micturitions per 24 hours was calculated by taking the sum of all marked episodes in the patient diary where the variable urinated was indicated, divided by the number of days on which episodes were recorded."|Baseline and week 4, 8, 12, 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||micturitions||Standard Deviation|Mean
2641515|NCT01745094|Secondary|Change From Baseline in OAB-q SF Total HRQL Score|The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the HRQL. The HRQL section included 13 questions. For each participant, the total HRQL score was derived as a sum of scores for Questions 7 to 19. The total score ranges from 13 to 78 with higher total HRQL score indicating greater HRQL. OAB-q SF data obtained at week 0 visit were used as baseline.|Baseline and week 8, 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||units on a scale||Standard Deviation|Mean
2641516|NCT01745094|Secondary|Change From Baseline in Overactive Bladder Questionnaire Short Form (OAB-q SF) Severity Score|The OAB-q SF questionnaire was a questionnaire completed by participants composed of 2 sections: Severity Symptom and the Health-related Quality of Life (HRQL). The Severity Symptom section included 6 questions. For each participant, the symptom severity score was derived as a sum of scores for Questions 1 to 6. The total score ranges from 6 to 36 with higher symptom severity score indicating greater symptom bother. OAB-q SF data obtained at week 0 visit were used as baseline.|Baseline and week 8, 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||units on a scale||Standard Deviation|Mean
2641517|NCT01745094|Secondary|Number of Participants Who Achieved Normalization for OABSS Total Score|Normalization for OABSS Total Score was defined as OABSS total score ≤ 2 or OABSS Question 3 score ≤ 1.|Week 8 and 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||Participants|||Count of Participants
2641518|NCT01745094|Secondary|Change From Baseline in OABSS Total Score|The OABSS questionnaire was a questionnaire completed by participants with 4 questions regarding their OAB symptoms. For each participant, the OABSS total score was calculated from the sum total of the score of each question. The total score ranges from 0 to 15 with higher score indicating more symptoms. The OABSS data obtained at week 0 were used as baseline.|Baseline and week 8, 16|FAS participants with available data at each time point are included in the analysis. A last visit analysis (at the end of study) was performed to ensure all patients with postbaseline data were included in the analyses. Last observation carried forward (LOCF) imputation was used for the end of study analysis.|||units on a scale||Standard Deviation|Mean
2641521|NCT01745055|Secondary|Total Amount of Unchanged Drug Excreted in the Urine From Time Zero to 24 Hours (Ae[0-24]) for Methotrexate (MTX)||0 (pre-dose) through 24 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||milligram||Standard Deviation|Mean
2641524|NCT01745055|Secondary|Apparent Oral Clearance (CL/F) for Methotrexate (MTX)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 , 12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||mL/hr||Standard Deviation|Mean
2641525|NCT01745055|Secondary|Plasma Decay Half-Life (t1/2) for Methotrexate (MTX)|Plasma decay half-life is the time measured for the plasma concentration of MTX to decrease by one half.|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 , 12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||hour||Standard Deviation|Mean
2641526|NCT01745055|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Methotrexate (MTX)||0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8 ,12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||hour||Full Range|Median
2641527|NCT01745055|Secondary|Apparent Oral Clearance (CL/F) for CP-690,550|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||mL/hr||Standard Deviation|Mean
2641528|NCT01745055|Secondary|Plasma Decay Half-Life (t1/2) for CP-690,550|Plasma decay half-life is the time measured for the plasma concentration of CP-690,550 to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||hour||Standard Deviation|Mean
2641529|NCT01745055|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for CP-690,550||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||hour||Full Range|Median
2641530|NCT01745055|Primary|Maximum Observed Plasma Concentration (Cmax) for Methotrexate (MTX)||0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8,12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||ng/mL||Standard Deviation|Mean
2641531|NCT01745055|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Methotrexate (MTX)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hours post-dose on Day 1 and Day 7|PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||ng*hr/mL||Standard Deviation|Mean
2641532|NCT01745055|Primary|Maximum Observed Plasma Concentration (Cmax) for CP-690,550||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|The PK analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||ng/mL||Standard Deviation|Mean
2641533|NCT01745055|Primary|Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)] for CP-690,550|AUC (0-12)= area under the plasma concentration time-curve from time zero (pre-dose) to 12 hours (0-12).|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8 and 12 hours post-dose on Day 6 and Day 7|The pharmacokinetic (PK) analysis population included all enrolled participants with PK parameters of interest for at least 1 period of fixed sequence.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
2641534|NCT01744977|Secondary|Change in LDL Cholesterol Level as Measured at Baseline, 6months, 12months|obtain non-fasting lipid panel at timepoints to review change in LDL cholesterol levels over the 12 month period (at baseline, 6 and 12 months)|Baseline, 6months, 12months|Cholesterol values could not be obtained for all patients at all time points.|||mg/dL||Standard Deviation|Mean
2641535|NCT01744977|Primary|Cholesterol Medication Adherence|Pill refill obtained at 12 months to review change in cholesterol medication adherence over the 12 month period between groups|12 months|Data on pill refill could not be obtained for 2 of the education only participants.|||adherence proportion||Inter-Quartile Range|Median
2641536|NCT01744860|Secondary|Management of Discordance-Final Result for BRAF V600 Mutation Detection|The final results obtained by discordance management of the 28 discordant samples were BRAF V600 mutation, No BRAF V600 mutation and Non-evaluable. These results were further assessed by the Investigator and interpreted as final result.|Up to 6 months|"The discordant sample population is defined as the samples whose result for BRAF V600 mutation by the in-house method did not show similar outcome with the cobas 4800 mutation test."|||number of samples|Participants||Number
2641537|NCT01744860|Secondary|Management of Discordance- Method Used to Manage Discordance|"Crossing DNA, DNA from In-House method analysed with cobas, SNaPshot, DNA from cobas analysed with In-House method, external site control test, Sanger sequencing, Kit CE-IVD Therascreen RGQ Qiagen, Kit Therascreen RGQ BRAF + Pyrosequencing by another platform (PF), Pyrosequencing, Mutation detection On Another Block, (primitive tumor [prm. tmr]), Sequencing And Therascreen kit (Qiagen) were used for management of discordance between in-house method and Cobas 4800 mutation test."|Up to 6 months|"The discordant sample population is defined as the samples whose result for BRAF V600 mutation by the in-house method did not show similar outcome with the cobas 4800 mutation test."|||number of samples|Participants||Number
2641538|NCT01744860|Secondary|Technician Work Time Between DNA Extraction and Result by Cobas 4800 BRAF V600 Mutation Test - Analytical Method|This cobas 4800 BRAF V600 Mutation Test analytical method measures the working time required by the technician from the time of DNA extraction to the time to obtain the results. The time duration was measured in hours.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||hours|Participants|Full Range|Median
2641539|NCT01744860|Secondary|Median Time Between Receipt of Sample and Determination of Result by Cobas 4800 BRAF V600 Mutation Test -Analytical Method|This analytical method for cobas 4800 BRAF V600 Mutation Test measured the time between receipt of samples to the result determination. It measured the time in days.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||days|Participants|Full Range|Median
2641540|NCT01744860|Secondary|Number of Slices Used When No Punch Was Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method|This describes the Cobas 4800 BRAF V600 Mutation Test, for the mean of number of slices when No punch method, was used. Of the 420 samples, punch was Yes, for 45 samples and punch was No, for 375 samples.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Data for the samples where the punch was No=375, was used for analysis.|||number of samples|Participants|Standard Deviation|Mean
2641541|NCT01744860|Secondary|Punch Used for Cobas 4800 BRAF V600 Mutation Test- Analytical Method|The punch done during Cobas 4800 BRAF V600 Mutation Test on the sample was described as Yes or No.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
2641542|NCT01744860|Secondary|Mean DNA Concentration as Measured by COBAS 4800 BRAF V600 Mutation Test-Analytical Method|The DNA concentration as assessed by COBAS 4800 BRAF V600 Mutation assay was reported. The unit used to measure the DNA concentration was nanogram/microlitre (ng/mcl)|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||ng/mcl|Participants|Standard Deviation|Mean
2641543|NCT01744860|Secondary|"Technician Work Time Between DNA Extraction and Result by In-house Analytical Method"|The working time required by the technician from the time of DNA extraction to the time to obtain the results was measured in hours.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||hours|Participants|Full Range|Median
2641544|NCT01744860|Secondary|"Median Time Between Receipt of Samples and Determination of Result by In-house Analytical Method"|This In-house analytical method measured the time between receipt of samples to the result determination. It measured the time in days.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||days|Participants|Full Range|Median
2641545|NCT01744860|Secondary|"Mean Number of Slices Per Sample Used for In-house- Analytical Method"|The mean of number of slices per sample when no punch was used are reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Data for the samples where the punch was not used were considered for analysis.|||number of samples|Participants|Standard Deviation|Mean
2641546|NCT01744860|Secondary|Number of Samples Punched in In-house Analytical Method|Total number of samples for whom punch was used in 'in-house analytical' method are reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
2641547|NCT01744860|Secondary|"Method of Mutation Detection by In-house Analytical Method"|Allele-specific PCR, High Resolution Melting (HRM) + Sanger sequencing, Pyrosequencing, Sanger sequencing, Real time PCR, SNaPshot were used for BRAF V600 mutation detection.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
2641548|NCT01744860|Secondary|"Size of Amplicons Used by In-house Analytical Method"|The method described the size of amplicon used. It was measured in base pairs (bp).|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||bp|Participants|Full Range|Median
2641549|NCT01744860|Secondary|Amount of DNA by Pre-analytical Method|The total DNA concentration extracted from the tissue was measured in nanogram (ng).|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||ng|Participants|Standard Deviation|Mean
2641550|NCT01744860|Secondary|Mean DNA Concentration by Pre-analytical Method|The DNA concentration in the tissue elute was measured in nanogram per microliter (ng/mcL).|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||ng/mcl|Participants|Standard Deviation|Mean
2641551|NCT01744860|Secondary|Median DNA Elution Volume by Pre-analytical Method|Median DNA elution volume microliters [mcl] was reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||mcl|Participants|Full Range|Median
2641552|NCT01744860|Secondary|DNA Extraction - Extraction Method by Pre-analytical Method|This method assessed DNA from the tumor samples was extracted by Automated method or Manual method.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
2641553|NCT01744860|Secondary|Tumor Samples With Presence of Melanin by Pre-analytical Method|The tumor samples with presence of melanin were categorized as Important, Few, Medium and Absent.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Only available samples were included for analysis.|||number of samples|Participants||Number
2641554|NCT01744860|Secondary|Percentage of Tumor Cells by Pre-analytical Method|The percentage of tumor cells in the given tumor sample were reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||percentage|Participants|Standard Deviation|Mean
2641555|NCT01744860|Secondary|Necrosis Percentage Determination by Pre-analytical Method|The percentage of necrosis defined as the death of one or more cells in the analysed zone was reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. Only 341 samples out of 420 were analysed as the information on presence of necrosis was missing for 79 samples in the assessed zones.|||percentage|Participants|Standard Deviation|Mean
2641556|NCT01744860|Secondary|Dewaxing by Pre-analytical Method|"Dewaxing is a method to recover the DNA from samples. Dewaxing information was collected as Yes, No or Missing"|Up to 6 Months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
2658565|NCT01597388|Primary|Sitting Diastolic Blood Pressure||28 Days|The analysis population consisted of all participants who received at least one dose of AZD2014.|||mmHg||Standard Deviation|Mean
2641557|NCT01744860|Secondary|Slice Thickness by Pre-analytical Method|Slice thickness of all the tumour samples was measured. The slice thickness was measured in micrometer.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||micrometer (µm)|Participants|Standard Deviation|Mean
2641558|NCT01744860|Secondary|Fixation Duration by Pre-analytical Method|Fixation duration is defined as the amount of time required in hours for the fixation of a samples. The fixation duration was categorized as <6 hours, 6-24 hours and >24 hours and unknown. Number of samples falling in each category were reported|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
2641559|NCT01744860|Secondary|Type of Fixative Used- Pre-analytical Method|The different types of fixative Excell, formol, alcohol formol acetic acid and other, used to fix the tumor samples were reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
2641560|NCT01744860|Secondary|Time From Sampling to Fixation- Pre-analytical Method|Time taken from the sampling to the fixation of the tumor sample was reported in range of 0-2 hours, 2-6 hours, >6 hours and unknown. Number of samples falling in each of the class were reported.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
2641561|NCT01744860|Secondary|Type of Pathology Laboratory Performing the Fixation or Embedding-Pre-analytical Method|The external or internal pathology laboratories involved in the process of fixation or embedding of the tumor sample was evaluated.|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
2641562|NCT01744860|Secondary|Tumor Sample Characteristics - Source of Tumor Sample|The source of tumor sample for BRAF V600 mutation detection whether taken from internal or external pathology laboratory were reported|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis.|||number of samples|Participants||Number
2641563|NCT01744860|Secondary|Tumor Sample Characteristics-Type of Tumor Sample|The type of tumor sample used for evaluation of BRAF V600 mutation whether it was a biopsy or surgical specimen were reported|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis|||number of samples|Participants||Number
2641564|NCT01744860|Primary|BRAF Mutation Status According to Cobas 4800 BRAF V600 Mutation Test vs. INCa Laboratories Molecular Genetics Laboratories|"BRAF V600 mutation status was determined by INCa molecular laboratories in-house methods and Cobas 4800 BRAF V600 mutation test. Samples were analysed as V600 mutation, No V600 mutation and Non evaluable. Additionally, the type of V600 mutation (E, K, R, D, E2, other V600 mutation, not specified) was also evaluated only by INCa molecular laboratory in-house method."|Up to 6 months|All samples meeting the inclusion criteria and not meeting the exclusion criteria were considered for analysis. n = number of samples with BRAF V600 mutation by “in-house method”.|||number of samples|Participants||Number
2641565|NCT01744821|Secondary|Review of the Differences in the Types and Incidence of Toxicities Associated With Vitamin D3 Replacement.|Differences in the types and incidence of toxicities associated with Vitamin D3 replacement, specifically hypercalcemia, with increasing levels of Vitamin D3 along with the effectiveness of Vitamin D3 supplementation on increasing serum levels of Vitamin D|Up to 24 months||||participants|||Number
2641566|NCT01744821|Secondary|Review of Standard Pathologic Evaluation With Specific Attention to Histologic Markers|"The outcomes that will be measured for the secondary objectives of this study will include the following:~Review of standard pathologic evaluation with specific attention to histologic markers including serous hyperplasia, tubal atypia, and p53 signature in the ovary and fallopian tube, and examine via immunohistochemistry the effects of vitamin D supplementation on expression of the TGF-beta isoforms and CYP24"|Up to 24 months|We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers.||||||
2641567|NCT01744821|Primary|Other Surrogate Endpoint Biomarkers Markers of Cancer Prevention|Decrease in cellular proliferation measured by immunohistochemistry staining with KI67|Up to 24 months|We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers.||||||
2641568|NCT01744821|Primary|The Outcomes That Will be Measured for the Primary Objectives of This Study Will be Surrogate Endpoint Biomarkers Markers of Cancer Prevention|Activation of apoptosis via immunohistochemical measurement of activation of caspase activity, as well as expression of BAX and BCL-2 The primary marker outcomes will be assessed for normality and compared between groups using a two-sample t-test or a Wilcoxon rank sum test. Other markers will be compared similarly if continuous, or by Fisher's exact test if categorical.|Up to 24 months|We failed to accrue enough patients in order to conduct this outcome measure. We collected the specimens but were unable to analyze them given the low accrual numbers.||||||
2641569|NCT01744782|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of Cysteamine|Blood samples were collected and plasma cysteamine concentration was determined using liquid chromatography. AUC values were estimated using non-compartmental analysis methods. AUClast was defined as the area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (720 minutes). AUCinf was defined as the area under the plasma concentration-versus-time curve from time 0 to infinity.|30 minutes after the morning RP103 dose at Month 6 (prior to Protocol Amendment 1) or 0 (pre-dose), 30 minutes, 2, 3, 4, 6, 8, 10, and 12 hours after the morning RP103 dose at Month 6 for those enrolled under Protocol Amendment 1 or later|Participants age <6 years who received at least 1 dose of RP103 and participated in frequent sampling at the Month 6 visit.|||min*mg/L||Standard Deviation|Mean
2641570|NCT01744782|Secondary|Time of the Maximum Observed Plasma Concentration (Tmax) of Cysteamine|Blood samples were collected and plasma cysteamine concentration was determined using liquid chromatography. The time of the maximum observed plasma concentration (Tmax) of cysteamine was determined directly from the data.|30 minutes after the morning RP103 dose at Month 6 (prior to Protocol Amendment 1) or 0 (pre-dose), 30 minutes, 2, 3, 4, 6, 8, 10, and 12 hours after the morning RP103 dose at Month 6 for those enrolled under Protocol Amendment 1 or later|Participants age <6 years who received at least 1 dose of RP103 and participated in frequent sampling at the Month 6 visit.|||minutes||Standard Deviation|Mean
2641571|NCT01744782|Secondary|Maximum Observed Plasma Concentration (Cmax) of Cysteamine|Blood samples were collected and plasma cysteamine concentration was determined using liquid chromatography. The maximum observed plasma concentration (Cmax) of cysteamine was determined directly from the data.|30 minutes after the morning RP103 dose at Month 6 (prior to Protocol Amendment 1) or 0 (pre-dose), 30 minutes, 2, 3, 4, 6, 8, 10, and 12 hours after the morning RP103 dose at Month 6 for those enrolled under Protocol Amendment 1 or later|Participants age <6 years who received at least 1 dose of RP103 and participated in frequent sampling at the Month 6 visit.|||mg/L||Standard Deviation|Mean
2641572|NCT01744782|Secondary|Number of Participants With Adverse Events|Safety was assessed by the incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs). An AE/adverse experience was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. For additional information regarding adverse events, please see the safety section of the record.|Day 1 through study exit|Safety population: All participants who received at least 1 dose of RP103.|||Participants|||Count of Participants
2641573|NCT01744782|Primary|Mean White Blood Cell (WBC) Cystine Concentration at Each Visit|Blood samples were taken 30 minutes after the morning RP103 dose at each study visit to determine White Blood Cell (WBC) cystine concentration. WBC cystine concentrations were determined using liquid chromatography.|Day 1, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Month 6, Month 9, Month 12, Month 15, Month 18, Study Exit|Participants <6 years of age who received at least 1 dose of RP103 and who had at least 1 WBC cystine level recorded.|||nmol 1/2 Cystine/mg protein||Standard Deviation|Mean
2641574|NCT01744730|Primary|PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese & non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for volume of distribution by age cohort normalized to 1kg of body weight are presented below.~Sampling schedule details for PTN_POPS & Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.|||L/kg||Full Range|Median
2641575|NCT01744730|Post-Hoc|Half-life|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of empirical Bayesian Estimates (EBE) for half-life by age cohort are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After participant transitioned from IV Clindamycin to oral Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.|||hours||Full Range|Median
2641576|NCT01744730|Primary|PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for volume of distribution by age cohort are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.|||L||Full Range|Median
2641584|NCT01744704|Primary|Change in Best Corrected Distance Visual Acuity (BCDVA)|"Best corrected distance visual acuity measured using the ETDRS (Early Treatment Diabetic Retinopathy Study) score. In this population, the scores range from -6 (worse visus) to 3 (best visus).~The study includes Part 0, Part A and Part B. In Part B BCDVA was evaluated on days -1, 1, 5, 15 (FU). Follow up (FU) refers to participants' last available assessment."|Day -1, Day 1, Day 5, Day 15 (FU)|Safety population consisted of all subjects randomised into the study and receiving a dose of study medication.|||units on a scale||Standard Deviation|Mean
2641625|NCT01744392|Primary|Medication Possession Ratio at 6 Months|"Medication Possession Ratio (MPR) is defined as the number of daily doses of medication dispensed by the pharmacy to each patient, divided by the patient's total follow-up time. The time period for the assessment for 6 months MPR 6 months after enrollment."|6 months||||percentage of medication possession||Standard Deviation|Mean
2641577|NCT01744730|Primary|Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for clearance by age cohort normalized to 70 kg of body weight are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.|||L/h/70 kg||Full Range|Median
2641578|NCT01744730|Primary|Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for clearance by age cohort normalized to 1 kg of body weight are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.|||L/h/kg||Full Range|Median
2641579|NCT01744730|Primary|Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.|"In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.~PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of empirical Bayesian Estimates (EBE) for clearance by age cohort are presented below.~Sampling schedule details for PTN_POPS and Staph Trio were comparable."|After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6).|In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status.|||L/h||Full Range|Median
2641580|NCT01744704|Primary|Percentage of Abnormal Findings in Dilated Fundus Ophthalmoscopy|"Dilated fundus ophthalmoscopy (DFO) is used to view the eye's interior, allowing assessment of the retina/macula/choroid, optic nerve head, blood vessels, and other features.~The outcome can be normal or abnormal. The study includes Part 0, Part A and Part B. In Part B this endpoint was evaluated on day 7."|Part B - Day 7|Safety population: consisted of all subjects randomised into the study and receiving a dose of study medication.|||percentage of abnormal findings||Standard Deviation|Mean
2641581|NCT01744704|Primary|Change in Intraocular Pressure (IOP)|"Intraocular pressure was determined using Goldmann applanation tonometry. The study includes Part 0, Part A and Part B. In Part B this endpoint was evaluated at screening and on days 7, 15 (FU).~Follow up (FU) refers to participants' last available assessment."|Screening, Day 7, Day 15 (FU)|Safety population: consisted of all subjects randomised into the study and receiving a dose of study medication.|||mmHg||Standard Deviation|Mean
2641582|NCT01744704|Primary|Change in Mean Corneal Fluorescein Staining|"Slit lamp examination was used to assess the eyelid margin, conjunctiva, cornea, anterior chamber, iris and lens with the instillation of fluorescein to evaluate corneal fluorescein staining (modified Oxford scale).~This is 7-point ordinal scale that scores 0, 0.5, and 1 to 5. On this scale the score 0 corresponds to no staining dots (complete corneal clearing) and the score 0.5 corresponds to three or less staining dots. The higher is the number of dots, the higher and worse is the score.~The study includes Part 0, Part A and Part B. In Part B the endpoint was evaluated on days -1, 1, 5, 15 (FU)."|Day -1, Day 1, Day 5, Day 15 (FU)|Safety population: consisted of all subjects randomised into the study and receiving a dose of study medication.|||Units on a scale||Standard Deviation|Mean
2641583|NCT01744704|Primary|Change in Mean Tear Film Break up Time (TFBUT)|"Tear film break-up time was assessed by slit lamp examination (SLE). The shorter is the tear film break-up time, the worse is the dry eye symptom severity.~The study includes Part 0, Part A and Part B. In Part B this endpoint was evaluated on days -1, 1, 5, 15 (FU). Follow up (FU) refers to participants' last available assessment."|Day -1, Day 1, Day 5, Day 15 (FU)|Safety population: consisted of all subjects randomised into the study and receiving a dose of study medication.|||seconds||Standard Deviation|Mean
2641616|NCT01744483|Primary|Percentage of Patients With Tracheal Bacterial Colonization|The percentage of patients with quantitative culture growth from tracheal aspirate specimens of >1,000,000 CFU between Day 2 and Day 4 of tracheal intubation/mechanical ventilation. Percentage of patients will be compared between the three study arms.|Tracheal colonization by Day 4 or extubation||||percentage of tracheal colonization|||Number
2641585|NCT01744704|Primary|Changes in VAS Ocular Tolerability|"A global ocular discomfort score was determined using a 100 mm visual analogue scale (VAS) on which 0 means no symptoms and 100 means the worst possible discomfort. This evaluation was performed before any ophthalmic assessment at a given study visit. Specific ocular symptoms to be assessed with the VAS included: foreign body sensation, burning/stinging, itching, pain, sticky feeling, blurred vision, photophobia.~Part 0: VAS evaluated on days -1, 1, 3, 10 (FU) Part A: VAS evaluated on days -1, 1, 3, 10 (FU) Part B: VAS evaluated on days -1, 1, 5, 15 (FU) Follow up (FU) refers to participants' last available assessment.~The Outcome Measure Time Points and Data Table refers to Part B."|Day -1, Day 1, Day 5, Day 15 (FU)|Safety population: consisted of all subjects randomised into the study and receiving a dose of study medication.|||units on a scale||Standard Deviation|Mean
2641586|NCT01744691|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|Number of participants who had experienced at least one treatment emergent AE|From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure|Participants who received at least 1 dose of PCI-32765 and constitute the all treated population.|||participants|||Number
2641587|NCT01744691|Primary|Overall Response Rate|The primary objective of this study is to evaluate the efficacy of ibrutinib in terms of ORR according to an Independent Review Committee (IRC). ORR based upon IRC assessment is the proportion of responders in the all treated population. Responders were subjects who achieved partial response (PR) or better, ie, complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR, per IWCLL 2008 criteria with the clarification for treatment-related lymphocytosis.|The median time on study for all treated participants is 33.3 (range 0.5 - 40.1) months|Efficacy analyses were performed on all 144 treated subjects. The primary analysis (PA) used IRC assessment of efficacy endpoints. In the PA, there were no differences between the IRC and investigator responses. IRC assessment was no longer performed after the PA and the final analysis result report investigator-assessed efficacy outcomes.|||% of participants with response by PI||95% Confidence Interval|Number
2641588|NCT01744665|Secondary|Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 12 in Treatment Free Remission Phase - Safety Set|The EuroQol Five Dimensional Three-level questionnaire (EQ-5D-3L) comprises 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 levels (no problems, some problems and extreme problems). The percentages of patients at each level of the five items of the EQ-5D-3L will be summarized at each time point|Month 12 in in Treatment Free Remission Phase|all completers did not complete all categories of questionaire|||Participants|||Count of Participants
2641589|NCT01744665|Secondary|Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 6 in Treatment Free Remission Phase - Safety Set|The EuroQol Five Dimensional Three-level questionnaire (EQ-5D-3L) comprises 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 levels (no problems, some problems and extreme problems). The percentages of patients at each level of the five items of the EQ-5D-3L will be summarized at each time point|Month 6 in in Treatment Free Remission Phase|all completers did not complete all categories of questionaire|||Participants|||Count of Participants
2641590|NCT01744665|Secondary|Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 24 in Consolidation Phase - Safety Set|The EuroQol Five Dimensional Three-level (EQ-5D-3L) questionnaire comprises 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 levels (no problems, some problems and extreme problems). The percentages of patients at each level of the five items of the EQ-5D-3L will be summarized at each time point|Month 24 in Consolidation Phase|all completers did not complete all categories of questionaire|||Participants|||Count of Participants
2641591|NCT01744665|Secondary|Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 12 in Consolidation Phase - Safety Set|The EuroQol Five Dimensional Three-level (EQ-5D-3L) questionnaire comprises 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 levels (no problems, some problems and extreme problems). The percentages of patients at each level of the five items of the EQ-5D-3L will be summarized at each time point|Month 12 in Consolidation Phase|all completers did not complete all categories of questionaire|||Participants|||Count of Participants
2641592|NCT01744665|Secondary|Percentage of Participants' Scores at Each Level Assessed by EQ-5D-3L for Month 3 in Consolidation Phase - Safety Set|The EuroQol Five Dimensional Three-level (EQ-5D-3L) questionnaire comprises 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item has 3 levels (no problems, some problems and extreme problems). The percentages of patients at each level of the five items of the EQ-5D-3L will be summarized at each time point|At month 3 in Consolidation Phase|all completers did not complete all categories of questionaire|||Participants|||Count of Participants
2641593|NCT01744665|Secondary|Change in Observed Scores for Patient Quality of Life Assessed by SF-8 - Safety Set|The SF-8 questionnaire consisted of 8 items (general health, physical functioning, role physical, bodily pain, vitality, social functioning, role-emotional and mental health) and was used to assess the impact of nilotinib treatment discontinuation on the quality of life. Each item had a 1 to 5 or 1 to 6 point response range and the higher number in the raw scores indicated poorer quality of life. The physical and mental component summary measures were calculated using a norm-based scoring method given in the instrument guidelines. These norm-based scores were summarized at baseline and mean change from baseline for post-baseline time points. The norm-based scores (based on the US population) had a mean of 50 and standard deviation of 10. Higher norm-based summary scores indicated better health|From baseline to time to when MR4.5 is confirmed and from end of Consolidation Phase to 6 and 12 months into the TFR Phase|Number of participants who completed questionnaire varied across visits|||scores on a scale||Standard Deviation|Mean
2641594|NCT01744665|Secondary|Change in Health Utility Assessed by EuroQol Group-5D-3L (EQ-5D-3L) Visual Analogue - Safety Set|The EQ-5D-3L questionnaire comprises 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and visual analog has a scale 0 to 100 (0=worst imaginable health state, 100=best imaginable health state).|From baseline to time to when MR4.5, up to 24 months, is confirmed and from end of Consolidation Phase to 6 and 12 months into the TFR Phase|Number of participants who completed questionnaire varied across visits|||scores on scale||Full Range|Median
2641617|NCT01744392|Secondary|Pulse at 6 Months|Clinical Characteristics at 6 month for Pulse|6 months||||beats per minute||Standard Deviation|Mean
2641595|NCT01744665|Secondary|Change in Symptom-burden Scores by the M.D. Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Assessment|The M.D. Anderson Symptom Inventory for CML patients (MDASI-CML) was used to assess the nature and impact of symptom burden on life. It consisted of 20 validated symptom items and 6 validated interference items. Each item was assessed on an 11 point scale with responses from 0-10, 0=not present and 10=as bad as you can imagine. Symptom score (SS) was calculated when a patient scored at least 8 items of the symptom items using the formula: (sum of scores for the items answered) / number of items answered. If a subject responded to < 8 symptom items, the score was considered missing. Interference score (IS) was calculated when a patient scored at least 4 items using the formula: (sum of scores for the items answered)/number of items answered. If a subject responded to < 4 interference items, the score was considered missing. The total symptom score was 0-200 and total interference score was 0-60. Mean change from baseline was summarized at all post-baseline time points|From baseline to time to when MR4.5 is confirmed, up to 24 months, and from end of Consolidation Phase to 6 and 12 months into the TFR Phase|Number of participants who completed questionnaire varied across visits|||scores on a scale||Standard Deviation|Mean
2641596|NCT01744665|Secondary|Overall Survival (OS)|OS was defined as the time from the date of cessation of nilotinib therapy to the date of death from any cause.|Baseline up to approximately 5 years||||participants|||Number
2641597|NCT01744665|Secondary|Number of Participants Who Progressed to Accelerated Phase/Blastic Crisis (AP/BC) or Died From From Any Cause.|"Progression to AP/BC and death where the failure event is the earliest occurrence of the following event: progression to AP/BC date."|Baseline up to approximately 5 years||||participants|||Number
2641598|NCT01744665|Secondary|Percentage of Participants Who Regained MR4.5 After Restarting Nilotinib Due to Molecular Relapse|The percentage of participants who regained MR4.5 after restarting nilotinib will be calculated as the number of patients who achieved MR4.5 after having lost MR4 divided by the number of patients who lost MR4.|Restart of nilotinib up to month 6, 12 and 24||||Participants|||Count of Participants
2641599|NCT01744665|Secondary|Percentage of Participants Without Molecular Relapse Within 12 and 24 Months After Starting the Treatment -Free Remission (TFR) Phase|The percentage of participants without confirmed loss of MRR at 12 and 24 months is calculated by dividing the number of patients with no documented confirmed loss of MR4 at 12 and 24 months after starting the nilotinib TFR phase by the number of patients who entered nilotinib TFR phase.|12 and 24 months after starting the TFR||||Participants|||Count of Participants
2641600|NCT01744665|Secondary|Relapse Free Survival is Defined as Time From the Date of Nilotinib Treatment Discontinuation to the First Documented Molecular Relapse (Confirmed Loss of MR4.5).|Relapse-free survival after the start of the TFR phase was summarized using the product-limit (Kaplan-Meier) estimates. The median for the relapse free survival and its 95% confidence intervals were provided. This analysis was performed on the FAS. Patients who dropped out without relapse were treated as censored observations.|7 years||||weeks||95% Confidence Interval|Median
2641601|NCT01744665|Primary|Percentage of Participants Without Molecular Relapse Within 6 Months After Starting the TFR Phase|Percentage of particpants without confirmed loss of MMR within 6 months following nilotinib TFR is calculated by dividing the number of patients with no documented confirmed loss of MR4, in the first 6 months after starting nilotinib TFR phase by the number of patients who entered nilotinib TFR phase. Molecular relapse is defined as having a confirmed BCR-ABL ratio above MMR (2 consecutive BCR-ABL levels >0.1% IS taken approximately 4 weeks apart).|6 months after stopping nilotinib therapy||||Participants|||Count of Participants
2641602|NCT01744574|Secondary|Average Number of Days to Relapse|Days to relapse defined as the number of days from quit date to the first day with a slip|Days 1 through 84||||days||Standard Deviation|Mean
2641603|NCT01744574|Secondary|Number of Participants With Breath Carbon Monoxide ≤5 Ppm at Weeks 4, 8 and 12|breath carbon monoxide ≤5 ppm at weeks 4, 8 and 12|Weeks 4, 8 and 12||||Participants|||Count of Participants
2641604|NCT01744574|Secondary|Number of Participants With Cotinine <50 ng/mL at Weeks 4, 8 and 12|urine cotinine <50 ng/mL at weeks 4, 8 and 12|Weeks 4, 8 and 12||||Participants|||Count of Participants
2641605|NCT01744574|Secondary|Number of Participants With Continuous Abstinence From Smoking at Week 12|continuous abstinence defined as having no slips at all prior to week 12|Week 12||||Participants|||Count of Participants
2641606|NCT01744574|Secondary|Number of Participants With Prolonged Abstinence From Smoking at Weeks 4, 8 and 12|Prolonged abstinence defined as having less than seven consecutive slips without a 24-hour period between any two slips prior to weeks 4, 8 and 12|Weeks 4, 8 and 12||||Participants|||Count of Participants
2641607|NCT01744574|Secondary|Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Weeks 8 and 12|7-day point prevalence abstinence from smoking defined as having no slips (i.e., a puff or more from a lit cigarette) in the seven days prior to weeks 8 and 12|Weeks 8 and 12||||Participants|||Count of Participants
2641608|NCT01744574|Primary|Number of Participants With 7-day Point Prevalence Abstinence From Smoking at Week 4|7-day point prevalence abstinence from smoking defined as having no slips (i.e., a puff or more from a lit cigarette) in the seven days prior to week 4|Week 4||||Participants|||Count of Participants
2641609|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the 7 Domain Scores of Classification of Pain in Parkinson's Disease|"The classification of pain in Parkinson's disease scale classifies pain in the following domains: musculoskeletal pain (item 1), chronic pain (items 2 and 3), fluctuation related pain (items 4, 5 and 6), nocturnal pain (items 7 and 8), oro-facial pain (items 9, 10 and 11), discoloration; edema/swelling (items 12 and 13), and radicular pain (item 14). Severity of the pain is measured on a scale from none (0) to severe (3) and frequency is measured on a scale from never (0) to very frequent (4).~A score of a single item was calculated by multiplying severity with frequency. A domain score was calculated as the sum of every individual score related to the respective domain. A negative value indicates an improvement."|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.|||scores on a scale||Standard Deviation|Mean
2641610|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the Combined Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living [ADL] Subscale) and III (Motor Subscale)|Part II of the Unified Parkinson's Disease Rating Scale (UPDRS) assesses the subject's activities of daily living. Part III assesses motor function. The UPDRS is completed by questioning the subject about his/her general state in conjunction with any observations made by the investigator (or designee) since the previous visit. Part II is subject-rated and Part III is physician-rated. The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score was calculated as the sum of these 13 individual scores. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score was calculated as sum of these 27 individual scores. The sum score of UPDRS Parts II and III is the sum of the corresponding single sum scores. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.|||scores on a scale||Standard Deviation|Mean
2641611|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the 7-Item Anxiety Subscore of the Hospital Anxiety and Depression Scale (HADS)|The Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983) is a 14-item self-assessment scale for detecting states of depression and anxiety in the setting of a hospital medical outpatient clinic. It comprises a 7-item anxiety subscale and a 7-item depressive subscale that are also measures of severity of the emotional disorder. The 14 items are scored between 0 and 3. The 7-item depression subscore and 7-item anxiety subscore were calculated as the sum of the 7 corresponding individual scores. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.|||scores on a scale||Standard Deviation|Mean
2641612|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the 7-Item Depression Subscore of the Hospital Anxiety and Depression Scale (HADS)|The Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith, 1983) is a 14-item self-assessment scale for detecting states of depression and anxiety in the setting of a hospital medical outpatient clinic. It comprises a 7-item anxiety subscale and a 7-item depressive subscale that are also measures of severity of the emotional disorder. The 14 items are scored between 0 and 3. The 7-item depression subscore and 7-item anxiety subscore were calculated as the sum of the 7 corresponding individual scores. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.|||scores on a scale||Standard Deviation|Mean
2641613|NCT01744496|Secondary|Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-Item Parkinson's Disease Questionnaire (PDQ-8)|The 8-Item Parkinson's Disease Questionnaire (PDQ-8) (Peto et al, 1998) is a self-administered questionnaire that provides a reliable measure of overall health status. The PDQ-8 contains 8 items of daily living, with 1 item selected from each of the following 8 scales: mobility, Activities of Daily Living (ADL), emotional well being, stigma, social support, cognitions, communication, and bodily discomfort. The total PDQ-8 score is the sum of all the individual items converted to a summary index score between 0 and 100, with lower scores indicating better health. A negative value indicates an improvement.|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.|||scores on a scale||Standard Deviation|Mean
2641614|NCT01744496|Secondary|Percentage of Responders at the End of the Maintenance Period|Responders are defined as patients experiencing a 2-Point or more Reduction on an 11-Point Likert Pain Scale from Baseline to the End of the Maintenance Period. An 11-Point Likert Scale was used to assess patients' average daily pain. The patient rated his/her average pain from 0 (no pain) to 10 (worst pain ever experienced).|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.|||percentage of responders|||Number
2641615|NCT01744496|Primary|Change From Baseline to the End of the Maintenance Period in Pain Severity Assessed Using an 11-point Likert Pain Scale|"An 11-Point Likert Scale was used to assess patients' average daily pain. The subject rated his/her average pain from 0 (no pain) to 10 (worst pain ever experienced).~The average pain experienced in the last 7 days was calculated by the mean of the daily Likert Pain Scores within the 7 days prior to the respective visit (ie, Likert Pain Scores with a date of assessment before the date of visit and on or after the date of visit - 7 days). A negative value indicates an improvement."|Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after an up to 7 weeks Titration Period)|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and includes all subjects who were randomized, received at least 1 dose of study medication, and had a valid primary efficacy Baseline measurement and at least 1 valid post-Baseline Maintenance or valid Withdrawal primary efficacy measurement.|||scores on a scale||Standard Deviation|Mean
2641618|NCT01744392|Secondary|Pulse at Baseline|Clinical Characteristics at Baseline for Pulse|baseline||||beats per minute||Standard Deviation|Mean
2641626|NCT01744392|Primary|Medication Possession Ratio at Baseline|"Medication Possession Ratio (MPR) is defined as the number of daily doses of medication dispensed by the pharmacy to each patient, divided by the patient's total follow-up time. The time period for the assessment for baseline MPR 12 months prior to enrollment."|baseline||||percentage of medication possession||Standard Deviation|Mean
2641627|NCT01744353|Secondary|Response Rate (if Patient's Tumor(s)Are Progressing or Being Controlled) Following Treatment With FOLFOX-A for Patients With Newly Diagnosed, Advanced Pancreatic Cancer.|Data below summarizes number of patients who experienced partial response. Partial response evaluated in this study using the international criteria proposed in the Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1 Response Criteria Partial Response (PR) At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters|pre-drug until disease progression, whichever comes first, for an expected average of 6 months||||participants|||Number
2641628|NCT01744353|Primary|Assessment of Toxicities to Define MTD of FOLFOX-Abraxane (A) for Newly Diagnosed, Advanced Pancreatic Cancer.|MTD (Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion) was defined by protocol documented and predefined DLT's in 3 dose levels.|For up to 30 days post completing drug, an expected average of 6 months||||participants|||Number
2641629|NCT01744340|Secondary|Response Rate (Whether Patient's Disease is Progressing or Being Controlled) of Patients With Head and Neck Cancer Treated With Eribulin Mesylate and Cetuximab.|"This shows patients able to achieve Stable disease or better as their best response during course of study participation. Response will be evaluated by Revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline v1.1 RECIST Guideline version 1.1 Response Criteria Complete Response:Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease:At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Stable Disease:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study"|From beginning of treatment to progression of disease, for an expected average of 1 year||||participants|||Number
2641630|NCT01744340|Primary|If Eribulin Mesylate, up to a Maximum Dose of 1.4 mg/m2 Day 1 and 8 of a 21 Day Cycle, Can be Safely Combined With Full Dose Cetuximab for Patients With Advanced Head and Neck Cancer and Colon Cancer.|"A DLT was defined as:~Grade 4 neutropenia (ANC < 500/mm3) for > 7 days~ANC <1000/mm3 with fever or infection~Platelets <25,000/mm3~Platelets <50,000/mm3 requiring transfusion~Grade 3 or grade 4 treatment related non-hematologic toxicities excluding alopecia. Grade 3 nausea, vomiting or diarrhea will only be considered a dose limiting toxicity if it occurs despite maximal medical support. Grade 3 or grade 4 hypomagnesemia will not be considered a dose limiting toxicity since it is an expected side effect of cetuximab and can be corrected. Other grade 3 or grade 4 electrolyte abnormalities will not be considered dose limiting toxicities if the electrolyte disorder can be corrected to grade 2 or less within 72 hours.~EGFR dermatologic toxicity should be graded according to the toxicity scale for EGFR associated reactions. The first episode of grade 3 or grade 4 rash will not be considered a DLT.~If any patient receives < 70% of the planned dose of eribulin mesylat"|From Day 1 of Drug through end of cycle 2 equals (approximately) 42 days|Outcome measure that address the dose of 1.4 mg/m2,6 patients were treated (1 head and neck 5 colon). 12 patients were enrolled in the course of the MTD dose finding,10 colon and 2 head and neck. All other results sections are inclusive of all patients(dose finding +expansion cohort).|||participants|||Number
2641631|NCT01744197|Secondary|Global Assessment of Satisfaction With Venipuncture|Rates of Satisfied and very satisfied are used to be compared between two groups.|30 minutes after the venipuncture.|Normal completion patients|||percentage of participants|||Number
2641632|NCT01744197|Primary|Percentage of Patients With No Pain (VAS=0)|The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS =0 is considered as patients with no pain and would also be compared between 2 groups.|30 minutes after the venipuncture.|Normal completion patients|||percentage of participants|||Number
2641633|NCT01744197|Primary|Percentage of Patients With No or Minor Pain (VAS<3)|The primary efficacy endpoint is the subject's report of pain intensity regarding the venipuncture using a 0-10 VAS. The VAS <3 is considered as patients with no or minor pain and would be compared between 2 groups.|30 minutes after the venipuncture.|Normal completion patients.|||percentage of participants|||Number
2641634|NCT01744093|Secondary|Physiologic Effects, as Measured by Levels of MMP Activity in Epithelial Lining Fluid Before and After Study Drug Administration.|Reduction of MMP activity in epithelial lining fluid and cells obtained by bronchoscopy and doxycycline levels in blood, ELF and bronchoalveolar lavage (BAL) cell pellets; change in FEV1.|12 weeks||2019-12-31|12/2019||||
2641635|NCT01744093|Secondary|Biologic Effects, as Measured by Levels of MMP Activity in Epithelial Lining Fluid Before and After Study Drug Administration|Reduction of MMP activity in epithelial lining fluid and cells obtained by bronchoscopy and doxycycline levels in blood, ELF and bronchoalveolar lavage (BAL) cell pellets; change in FEV1.|12 weeks||2019-12-31|12/2019||||
2641636|NCT01744093|Primary|Tolerability of Doxycycline, as Measured by the Number of Subjects With a Dose-limiting Toxicity|To determine the tolerability of twice daily doxycycline for 6 months in HIV-infected subjects with COPD and/or emphysema as measured by those subjects experiencing a dose-limiting toxicity|24 weeks||||Participants|||Count of Participants
2641637|NCT01744093|Primary|Safety of Doxycycline, as Measured by the Number of Subjects With Any Treatment-related Adverse Events.|To determine the safety of twice daily doxycycline for 6 months in HIV-infected subjects with COPD and/or emphysema as measured by the number of subjects with any treatment-related adverse events.|24 weeks||||Participants|||Count of Participants
2641638|NCT01743963|Secondary|Feasibility/Reach/Adoption|Measurements of intervention delivery include numbers of veterans excluded from the intervention. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).|12 months|||||||
2641639|NCT01743963|Secondary|Feasibility/Reach/Adoption|Measurements of intervention delivery include the rationale used by clinicians declining participation. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).|12 months|||||||
2641640|NCT01743963|Secondary|Feasibility/Reach/Adoption|"Measurements of intervention delivery include the representativeness of providers (differences between participants/non-participants). Results reported using descriptive statistics (proportions, means, standard deviations, and ranges)."|12 months|||||||
2641641|NCT01743963|Secondary|Feasibility/Reach/Adoption|Measurements of intervention delivery include recruitment numbers and provider Participation Rates for enrollment and retention. The definition of study feasibility consists of provider enrollment rates >= 50%. Results reported using descriptive statistics (proportions, means, standard deviations, and ranges).|12 months|||||||
2641642|NCT01743963|Primary|Delay Interval (Days From Randomization Until the Provider Signs the Order for a hgbA1C Level).|For follow-up laboratory data within the VA system, adherence will be monitored through prospective accrual of administrative data and review of the medical record. Results will be reported as the proportion receiving the preventive measure versus time, i.e. with Kaplan-Meier plots. We will then determine the variance of Delay Interval. For the preliminary measure of efficacy, the Delay Interval will be compared between patients whose providers were assigned to the intervention and patients whose providers did not receive the intervention.|6 MONTHS|21 patients cared for by 6 providers in intervention arm; 17 patients cared for by 6 providers in usual care arm.|||Days||95% Confidence Interval|Mean
2641643|NCT01743859|Secondary|Determine Biomarkers That Predict Response/Toxicity|Change in baseline to end of study. Planned assessments of methylation changes and other biomarkers. Computational biology modeling used to identify biomarkers and predict response.|Three years after initiating study|Relapsed and refractory AML patients who received azacitidine and lenalidomide.|||patients w/response predictor mutations|||Number
2641644|NCT01743859|Secondary|Progression-free Survival|Change in baseline to end of study. To be assessed by standard criteria based on bone marrow examination|Depending on outcomes, will initiate this assessment after 2 years and will continue until completion of study, estimated at 4 years|Relapsed and refractory AML patients who received azacitidine and lenalidomide|||days||95% Confidence Interval|Median
2641645|NCT01743859|Secondary|Overall Survival|Change in baseline to end of study|Depending on outcomes, will begin assessment at 2 years and will continue until completion of study, estimated to be at four years|Relapsed and refractory AML patients who received azacitidine and lenalidomide|||days||95% Confidence Interval|Median
2641646|NCT01743859|Secondary|Toxicity and SAEs Related to Treatment|Change in baseline to end of study. To be measured based on Common Terminology Criteria for Adverse Events (CTCAE) criteria|Will begin assessment with first patient and will continue until completion of study, estimated to be 4 years|Relapsed and refractory AML patients who received azacitidine and lenalidomide -See toxicity data reported for results|||percentage of SAEs related to treatment|||Number
2641647|NCT01743859|Secondary|Response or Remission Duration|Change in baseline to end of study. To be assessed by standard criteria based on bone marrow examination|Depending on outcomes, will initiate this assessment after 2 years and will continue until completion of study, estimated at 4 years|Relapsed and refractory AML patients who received azacitidine and lenalidomide|||days||95% Confidence Interval|Median
2641648|NCT01743859|Primary|Overall Response Rate|Change in baseline to end of study. To be assessed by standard criteria based on bone marrow examination|Planned assessment after enrollment of all 37 patients (estimated 3-4 years)|relapsed/refractory patients who received azacitidine and lenaldiomide|||percentage of participants|||Number
2641649|NCT01743859|Primary|Percentage of Participants With Complete Remission or Complete Remission With Incomplete Recovery Blood Counts|Change in baseline to end of study. To be assessed by standard criteria based on bone marrow examination. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Interim assessment after 18 patients (estimated 2 years) and full assessment after 37 patients (estimated 3-4 years)|Relapsed/refractory AML patients who received azacitidine and lenalidomide|||percentage of participants|||Number
2641650|NCT01743729|Primary|Change From Baseline in Eye Dryness Score (Visual Analogue Scale) to Day 84|Eye dryness score was assessed on a visual analogue scale (a 7-item [burning/stinging, itching, foreign body sensation, eye discomfort, eye dryness, photophobia, and pain], participant-reported, symptom index) with scores ranging from 0 to 100 (0=no discomfort; 100=maximal discomfort) and lower scores indicate a better outcome.|Baseline to Day 84|ITT population with last observation carried forward (LOCF).|||units on a scale||Standard Deviation|Mean
2641651|NCT01743729|Primary|Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 84|Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining; 1=few/rare punctate lesions; 2=discrete and countable lesions; 3=lesions too numerous to count, but not coalescent; 4=coalescent) with 0.5 point increments, and lower scores indicate improvement. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.|Baseline to Day 84|Intent-to-treat (ITT) set included all randomized participants who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2641652|NCT01743560|Secondary|Change From Baseline in EuroQoL 5-dimension Visual Analogue Scores - FAS|EuroQoL Quality of Life Scale (EQ-5D) is a standardized instrument to assess health state values. The EQ-5D essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (VAS). For the visual analogue scale, participants draw a line from a box to the point on the thermometer-like scale corresponding to their health state, 0-100 (100 = Best health state). Weights are used to score the responses to the 5 domains, with scores ranging from 0 to 1 (where a score of 1 represents a perfect state). Scores for the visual analogue scale reflect the position where participant's line crosses the thermometer-like scale. Results should be interpreted with caution as the numbers of patients with available data over time were limited, and because of high variances as evidenced by large standard deviations|Baseline 12,24,36,48 weeks||||units on a scale||Standard Deviation|Mean
2641936|NCT01740713|Primary|Ka|Absorption rate constant. The parameter was estimated through a population pharmacokinetic model, during which concentration data obtained after single oral dose ( at 3 dose levels) of DFP in patients aged from 1 month to less than 6 years of age.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)||||h^-1||Standard Error|Mean
2641653|NCT01743560|Secondary|Percentage of Patient Responses in EuroQoL 5-dimension Questionnaire - FAS|EuroQoL Quality of Life Scale (EQ-5D) is a standardized instrument to assess health state values is a standardized instrument to assess health state values. The EQ-5D essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (VAS). The EQ-5D descriptive system is comprised of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Percentage of participants' responses were presented by visits. Results should be interpreted with caution as the numbers of patients with available data over time were limited.|Baseline 12,24,36,48 weeks||||Percentage of participants|||Number
2641654|NCT01743560|Secondary|Change From Baseline EORTC Quality of Life Questionnaire of Cancer Patients QLQ-C30 at Each Time Point|The QLQ-C30 is composed of multi-item scales and single-item measures including 5 functional scales, 3 symptom scales, a global health status-QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items - no item occurs in more than 1 scale. High scale score=higher response level; a high score for a functional scale=a healthy level of function, high score for the global health status/QoL=high quality of life but a high score for a symptom scale / item=high level of symptomatology/problems. The principle for scoring these scales: 1.) Estimate the average of the items that contribute to the scale = raw score. 2.) Linear transformation to standardize the raw score, so that scores range from 0 to 100. Results should be interpreted with caution as the numbers of patients with available data over time were limited, and because of high variances as evidenced by large standard deviations|Baseline 12,24,36,48 weeks|number of participants varied across visits|||scores||Standard Deviation|Mean
2641655|NCT01743560|Secondary|Overall Survival (OS) - % Event-free Probability Estimate - FAS|Overall survival (OS) is defined as the time from date of start of treatment to date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last contact.|Start of treatment to the date of death up to approximately 48 weeks|Full analysis set|||Percentage of participants||95% Confidence Interval|Number
2641656|NCT01743560|Secondary|Overall Survival (OS) Events (Number of Deaths) - FAS|Overall survival (OS) is defined as the time from date of start of treatment to date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last contact. Time to median OS was not estimable.|Start of treatment to the date of death up to approximately 48 weeks|Full analysis set|||Number of events|||Number
2641657|NCT01743560|Secondary|Progression-free Survival (PFS) - % Event-free Probability Estimate - FAS|Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor assessment and response was evaluated according to RECIST v1.1Response was assessed by local radiology review. The PFS was analyzed using the Kaplan Meier method.|Start of treatment to the date of event defined as first documented progression due to any cause up to approximately 48 weeks|Full analysis set|||Percentage of participants||95% Confidence Interval|Number
2641658|NCT01743560|Secondary|Progression-free Survival (PFS) by Median Time in Weeks as Per Investigators - FAS|Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor assessment and response was evaluated according to RECIST v1.1Response was assessed by local radiology review.|Start of treatment to the date of event defined as first documented progression due to any cause up to approximately 48 weeks|Full analysis set|||weeks||95% Confidence Interval|Median
2641659|NCT01743560|Secondary|Progression-free Survival (PFS) Events as Per Investigators - FAS|Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor assessment and response was evaluated according to RECIST v1.1Response was assessed by local radiology review.|Start of treatment to the date of event defined as first documented progression due to any cause up to approximately 48 weeks|Full analysis set|||Number of events|||Number
2641660|NCT01743560|Primary|Overall Response Rate of Everolimus and Exemestane Treatment in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer|The Overall Response Rate (ORR) was defined as the proportion of patients with a best OR of confirmed CR or PR by week 48. Treatment success is defined as: The best Overall Response (OR) for each patient is determined from the sequence of investigator overall lesion responses according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.). To be assigned a best OR of Complete Responese (CR) at least two determinations of CR at least 4 weeks apart before progression are required. To be assigned a best OR of Partial Response (PR) at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required.|At 48 weeks|FAS|||Percentage of participants||95% Confidence Interval|Number
2641661|NCT01743560|Primary|Best Overall Response of Everolimus and Exemestane Treatment in Postmenopausal Women With Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer|The best Overall Response (OR) for each patient is determined from the sequence of investigator overall lesion responses according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.). To be assigned a best OR of Complete Responese (CR) at least two determinations of CR at least 4 weeks apart before progression are required. To be assigned a best OR of Partial Response (PR) at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR) are required.The Overall Response Rate (ORR) was defined as the proportion of patients with a best OR of confirmed CR or PR by week 48.|At 48 weeks|FAS|||participants|||Number
2641662|NCT01743521|Secondary|Gene IL28B Polymorphism|To examine treatment outcome by IL28B polymorphism|Baseline|IL28B polymorphisms have not yet been performed. These are planned to be performed at a later date.||||||
2641663|NCT01743521|Secondary|CD4 and HIV RNA|In HIV positive participants to evaluate changes in CD4 counts and HIV RNA during telaprevir based therapy|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|This data will not be analysed.||||||
2641664|NCT01743521|Secondary|Plasma Ribavirin Levels|To correlate plasma ribavirin levels with treatment outcome and changes in haemoglobin during therapy|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|Ribavirin concentration have not yet been performed. These are planned to be performed at a later date.||||||
2641665|NCT01743521|Secondary|Baseline Resistance-associated Variants|To correlate the presence and frequency of baseline resistance-associated variants (RAVs) with the response of Telaprevir based therapy for early chronic HCV infection.|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|Baseline resistance-associated variants analysis have not yet been performed. These are planned to be performed at a later date.||||||
2641666|NCT01743521|Secondary|Resistance-associated Variants|To examine the emergence of resistance-associated variants during telaprevir based therapy for early chronic infection|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)|Resistance-associated variants analysis have not yet been performed. These are planned to be performed at a later date.||||||
2641667|NCT01743521|Secondary|Change in Hemoglobin at End of Treatment|To evaluate indicators of toxicity during telaprevir based therapy|Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)||||g/L||Inter-Quartile Range|Median
2641668|NCT01743521|Secondary|Decrease in Platelets <50||Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)||||participants|||Number
2641669|NCT01743521|Secondary|Decrease in Absolute Neutrophil Count (ANC) ≤0.75||Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)||||participants|||Number
2641670|NCT01743521|Secondary|Undetectable HCV RNA (Week 4)|To evaluate the proportion of patients with undetectable HCV RNA at week 4 of therapy.|Week 4 of therapy|Missing data carried forward if previously <LLoQ|||percentage of participants|||Number
2641671|NCT01743521|Secondary|Undetectable HCV RNA (Week 3)|To evaluate the proportion of patients with undetectable HCV RNA at week 3 of therapy.|Week 3 of therapy|Missing data carried forward if previously <LLoQ (lower limit of quantification)|||percentage of participants|||Number
2641672|NCT01743521|Secondary|Undectectable HCV RNA (Week 2)|To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy.|Week 2 of therapy||||percentage of participants|||Number
2641673|NCT01743521|Secondary|Undetectable HCV RNA (Week 1)|To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy.|Week 1 of therapy||||percentage of participants|||Number
2641674|NCT01743521|Secondary|Undetectable HCV RNA (ETR)|To evaluate the proportion of patients with undetectable HCV RNA at end of treatment (ETR)|Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)||||percentage of participants|||Number
2641675|NCT01743521|Secondary|SVR24|To evaluate the proportion of patients with undetectable HCV RNA 24 weeks after therapy completion (SVR24)|24 weeks post-treatment||||percentage of participants|||Number
2641676|NCT01743521|Primary|SVR12 (Sustain Virological Response, HCV RNA Undetectable 12 Weeks Post-treatment)|Proportion of subjects achieving SVR 12 (negative qualitative HCV RNA 12 weeks after therapy completion)|12 weeks post-treatment||||percentage of participants|||Number
2641677|NCT01743469|Secondary|Further Cancer-related Treatment During Follow-up Period (All Cohorts).|"Further systemic treatment was coded using World Health Organization (WHO) Drug Dictionary (versions: June 2014 for the hepatocellular carcinoma cohort and June 2013 for the ovarian, renal cell and gastric carcinoma cohorts).~A frequency table of the number and percentage of patients was provided by Anatomical Therapeutic Chemical (ATC) decode and preferred name."|16 weeks, Last Patient First Treatment + 16 weeks.|ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.|||Participants|||Count of Participants
2641678|NCT01743469|Secondary|Overall Survival (OS), Defined as the Time From First Study Treatment to Death Due to Any Cause (All Cohorts).|"OS is the time (in weeks) from the first study medication date to death due to any cause. Patients were censored at the date of last contact (the latest between the time of EoST/WD assessment and follow-up visits).~OS was estimated using Kaplan-Meier analysis."|Time from first study treatment to death, up to 36 months.|ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.|||Weeks||95% Confidence Interval|Median
2641679|NCT01743469|Secondary|TTP by RECIST v1.1 (All Cohorts).|TTP was defined as the time from first study treatment to the first occurrence of disease progression defined according to centrally and locally assessed RECIST v1.1 criteria (i.e. increase in tumor size ≥20%) or death due to disease progression before initiation of a new systemic treatment.|Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).|ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.|||Weeks||95% Confidence Interval|Median
2641680|NCT01743469|Secondary|Time to Progression (TTP) by Choi Criteria (Hepatocellular Carcinoma Cohort).|TTP defined as the time from first study treatment to the first occurrence of disease progression defined according to centrally assessed Choi criteria (i.e. increase in tumor size ≥10%) or death due to disease progression before initiation of a new systemic treatment.|Every 8 weeks until disease progression, up to 36 months.|ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.|||Weeks||95% Confidence Interval|Median
2641681|NCT01743469|Secondary|PFS From First Study Treatment to Progression or Death Due to Any Cause Based on RECIST v1.1 Criteria (All Cohorts).|PFS defined as the time from first study treatment to the first occurrence of a disease progression according to centrally and locally assessed RECIST v1.1 (i.e. increase in tumor size ≥20%) or death due to any cause before initiation of new systemic treatment.|Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).|ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.|||Weeks||95% Confidence Interval|Median
2641682|NCT01743469|Secondary|PFS From First Study Treatment to Progression or Death Due to Any Cause Based on Choi Criteria (Hepatocellular Carcinoma Cohort).|PFS defined as the time from first study treatment to the first occurrence of a disease progression according to centrally assessed Choi criteria (i.e. increase in tumor size ≥10%) or death due to any cause before initiation of new systemic treatment.|Every 8 weeks until disease progression, up to 36 months.|ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.|||Weeks||95% Confidence Interval|Median
2641733|NCT01742078|Secondary|Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD)|A BMD test measures the amount of mineral (such as calcium) in a defined area of bone in grams per square centimeter (g/cm²) and is calculate by dexascan.|Baseline (predose), Day 29 anytime, Day 85 anytime|All participants who received study drug and had evaluable results at the analyzed time points.|||gram per square centimeter (g/cm^2)||90% Confidence Interval|Least Squares Mean
2641683|NCT01743469|Secondary|Clinical Benefit (All Cohorts).|Clinical benefit was defined as CR, PR or SD lasting at least 12 weeks using centrally or locally assessed RECIST v1.1.|Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).|ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.|||percentage of participants||95% Confidence Interval|Number
2641684|NCT01743469|Secondary|Best Overall Response and Response Rate Based on Choi Criteria (Hepatocellular Carcinoma Cohort).|Per Choi Criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=10% decrease in the sum of the longest diameter of target lesions; Progression, as a 10% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.|Every 8 weeks until disease progression, up to 36 months.|ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.|||percentage of participants||95% Confidence Interval|Number
2641685|NCT01743469|Secondary|Best Overall Response and Response Rates (All Cohorts) Using RECIST v1.1 (Centrally and Locally Analysed).|Best overall response was derived as the best overall response documented before the prespecified timepoint (gastric carcinoma cohort: 12 weeks; Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.|Every 6 weeks until Week 24, thereafter, every 8 weeks until disease progression, up to 36 months (gastric carcinoma cohort); every 8 weeks until disease progression, up to 36 months (all other cohorts).|ITT population: all treated patients i.e. all patients who had received at lease one dose of tasquinimod.|||percentage of participants||95% Confidence Interval|Number
2641686|NCT01743469|Secondary|PFS Rate Measured by Choi Criteria (Hepatocellular Carcinoma Cohort).|"PFS rate was defined as the percentage of patients who had neither progressed nor died. Tumour progression was assessed centrally using the Choi criteria.~Response was measured using the following criteria:~CR: Disappearance of all lesions, no new lesions; PR: A decrease in size ≥10% or a decrease in tumour attenuation (Hounsfield unit [HU]) ≥15% on CT, no new lesions, no obvious progression of non-measurable disease; SD: Does not meet criteria for CR, PR, or progressive disease (PD), no symptomatic deterioration attributed to tumour progression; PD: An increase in tumour size ≥10% and does not meet criteria of PR by tumour attenuation on CT, new lesions."|Week 16.|ITT population: all treated patients i.e. all patients who had received at least one dose of tasquinimod.|||percentage of participants||95% Confidence Interval|Number
2641687|NCT01743469|Primary|Progression Free Survival (PFS) Rate, Defined as the Percentage of Patients Who Had Neither Progressed Nor Died as Measured by Centrally Analysed RECIST v1.1 (All Cohorts).|"Progression (prog.) defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in sum of longest diameter of target lesions,or a measurable increase in a nontarget lesion,or appearance of new lesions.~'Progressed or Died' when time between start of study drug &first date of the following events was ≤ to analysis timepoint +3 days:1) Disease prog. according to central review using RECIST v1.1:date of disease prog. or if missing,first exam date of the visit showing a disease prog.2) Death due to any cause.~'Neither progressed, nor died' if central assessment by RECIST v1.1 confirmed no disease prog. was observed at the considered timepoint,i.e. time between start of study medication &last examination/visit date of complete response (CR),partial response (PR) or stable disease (SD) ≥ analysis timepoint 7days.In other cases, such as patient withdrawal due to AEs without tumor assessment proving prog.,the patient was considered as 'not assessable'."|Week 12 (Gastric Carcinoma Cohort); Week 16 (Hepatocellular and Renal Cell Carcinoma Cohorts); Week 24 (Ovarian Carcinoma Cohort).|ITT population: All treated patients i.e. all patients who had received at least one dose of tasquinimod. An additional patient was included in the hepatocellular carcinoma cohort, since the 52nd (last patient planned in the protocol) and 53rd were screened at the same time. This 53rd was not included in the primary analysis.|||percentage of participants||95% Confidence Interval|Number
2641688|NCT01743092|Secondary|DASS Depression|"The Depression, Anxiety and Stress Scale (DASS 21) is a 21 item self-report questionnaire developed by Lovibond, S.H. & Lovibond, P.F. (1995, Manual for the Depression Anxiety Stress Scales, 2nd. Ed., Sydney: Psychology Foundation).~The range of total scores for each subscale is from 0 to 21. Higher values represent a worse outcome. Depression Normal 0-4 Mild 5-6 Moderate 7-10 Severe 11-13 Extremely Severe 14+ Anxiety Normal 0-3 Mild 4-5 Moderate 6-7 Severe 8-9 Extremely Severe 10+ Stress Normal 0-7 Mild 8-9 Moderate 10-12 Severe 13-16 Extremely Severe 17+"|12 weeks|The number of data points in this analysis equals the number who completed the study.|||units on a scale||Standard Deviation|Mean
2641689|NCT01743092|Primary|Perceived Stress Scale|"The questionnaire asks the client about their perceived stress. The Perceived Stress Scale (Cohen, S., Kamarck, T., and Mermelstein, R. (1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24, 386-396. December 1983) is a scale developed to measure the degree to which situations in one's life are appraised as stressful. Psychological stress has been defined as the extent to which persons perceive (appraise) that their demands exceed their ability to cope. The PSS has become one of the most widely used psychological instruments for measuring nonspecific perceived stress.~The scale has ten questions asking respondents to circle a number between 0 and 4. (0 the feelings and thoughts during the last month: 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often. The range of possible score is from 0 to 40. Scores around 13 are considered average. Scores of 20 or higher are considered to be indicative of high stress levels."|12 weeks|The number of data points in this analysis equals the number who completed the study, minus 2. There were 2 missing data points in this analysis because two people did not complete the questionnaire.|||units on a scale||Standard Deviation|Mean
2641734|NCT01742078|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546||Day 1: Predose,30 minutes,45 mintues,1 hour (hr), 1.5 hr, 3 hr, 6 hr, 12 hr Postdose; Day (D) 3,D5 ,D8, D11, D15, D29, D43, D57, D71,D85: anytime|All participants who received study drug and had sufficient evaluable results for PK analysis.|||picomol*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2641690|NCT01743027|Secondary|Proportion of Itch Responders at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.|Day 1|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.Patients with missing data were considered as nonresponders in this analysis.|||percentage of participants|||Number
2641691|NCT01743027|Secondary|Proportion of Ocular Itching Responders at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.|Day 14|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. Patients with missing data were considered as nonresponders in this analysis.|||percentage of participants|||Number
2641692|NCT01743027|Secondary|Mean Total Redness at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.|Day 1 (7, 15, and 20 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.|||units on a scale||Standard Error|Least Squares Mean
2641693|NCT01743027|Secondary|Mean Total Redness at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.|Day 14 (7, 15, and 20 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.|||units on a scale||Standard Error|Least Squares Mean
2641694|NCT01743027|Secondary|Mean Conjunctival Redness at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|Day 1 (7, 15, and 20 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.|||units on a scale||Standard Error|Least Squares Mean
2641695|NCT01743027|Secondary|Mean Conjunctival Redness at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|Day 14 (7, 15, and 20 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.|||units on a scale||Standard Error|Least Squares Mean
2641696|NCT01743027|Primary|Mean Ocular Itching at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.|Day 1 (3, 5, and 7 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.|||units on a scale||Standard Error|Least Squares Mean
2641697|NCT01743027|Primary|Mean Ocular Itching at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.|Day 14 (3, 5, and 7 minutes post-CAC)|Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.|||units on a scale||Standard Error|Least Squares Mean
2641698|NCT01743001|Secondary|Change From Baseline to Week 16 in Quality of Life (QoL), Assessed by the Short Form-36 (SF-36) Questionnaire|"The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of the functional health and well-being scores (i.e., physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health), as well as psychometrically based physical and mental health summary measures and a preference-based health utility (health rated as much better now than one year ago to much worse now than one year ago). It is a generic measure, as opposed to one that targets a specific age, disease, or treatment group.~For each of the domains and scores that the SF36 measures an aggregate percentage score is produced. The percentage scores range from 0% (lowest or worst possible level of functioning) to 100% (highest or best possible level of functioning). A higher score for the individual domains and summary component scores indicates a better condition of the subject."|From baseline to Week 16|Full analysis set (excluding children <14 years of age and Down Syndrome subjects)|||Score on a scale||Standard Deviation|Mean
2641699|NCT01743001|Secondary|Change From Baseline to Week 16 in Dyspnea, Assessed by the Borg Dyspnea Index|This outcome measures the difference in the Borg dyspnea index collected at the end of the 6-minute walk test (6MWT) at Week 16 compared to baseline. The Borg dyspnea index rates the severity of dyspnea (difficult or labored breathing) on a scale from 0 ('Nothing at all') to 10 ('Very, very severe - maximal'). A decrease in the Borg dyspnea index indicates an improvement.|From baseline to Week 16|Full analysis set: The analysis was performed on the full analysis set (FAS), i.e., all randomized subjects in the treatment group to which they were randomized and by imputing missing values at Week 16 according to pre-defined rules.|||Score on a scale||Standard Deviation|Mean
2641790|NCT01741688|Secondary|Percentage of Participants Discontinued From Tocilizumab for Safety|Safety variable measuring number of patients that discontinued tocilizumab due to adverse reactions to tocilizumab.|Approximately 16 months||||percentage of participants|||Number
2641700|NCT01743001|Secondary|Change From Baseline to Week 16 in WHO Functional Class|A shift in WHO functional classes is considered an 'improvement' when shifting to a lower class (e.g. from class III to class II) or a 'worsening' when shifting to a higher class (e.g. from class III to class IV). Definition of functional classes as follows - Class I: no symptoms with exercise or at rest. Class II: No symptoms at rest but uncomfortable and short of breath with normal activity such as climbing a flight of stairs, grocery shopping, or making the bed. Class III: May not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting (e.g. doing normal chores around the house, have to take breaks while doing activities of daily living). Class IV: Symptoms at rest and severe symptoms with any activity. Most patients also have edema in the feet and ankles as result of right heart failure.|From baseline to Week 16|Full analysis set: The analysis was performed on the full analysis set (FAS), i.e., all randomized subjects in the treatment group to which they were randomized and by imputing missing values at Week 16 according to pre-defined rules.|||Participants|||Count of Participants
2641701|NCT01743001|Primary|Change From Baseline to Week 16 in Exercise Capacity, as Measured by 6-minute Walk Distance (6MWD)|The purpose of the six minute walk is to test exercise tolerance and capacity. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.|From baseline to Week 16|Full analysis set: The analysis was performed on the full analysis set (FAS), i.e., all randomized subjects in the treatment group to which they were randomized and by imputing missing values at Week 16 according to pre-defined rules.|||meter||Standard Deviation|Mean
2641702|NCT01742949|Secondary|Preference|Through a questionnaire, the participant is asked to picked rather they prefer treatment A (No ThermoSmart) or treatment B (ThermoSmart). If they did not pick neither, it is considered no preference.|8 weeks||||Participants|||Count of Participants
2641703|NCT01742949|Secondary|Subjective Sinusitis|"Measured through a visual analog scale. The patient has to mark a cross on the scale to indicate the severity of their symptoms. On the left side of the scale has not at all and on the right side of the scale has extremely, In order to analyze the data, a ruler from the start of the scale (Left side) to the middle of the cross is measured in cm. The total length of the scale is 14 cm. Therefore, the minimum score is 0 and the maximum score is 14. The higher the score means that the participant is experiencing more symptoms."|8 weeks||||units on a scale||Standard Deviation|Mean
2641704|NCT01742949|Secondary|Subjective Dry Mouth|"Measured through a visual analog scale. The patient has to mark a cross on the scale to indicate the severity of their symptoms. On the left side of the scale has not at all and on the right side of the scale has extremely, In order to analyze the data, a ruler from the start of the scale (Left side) to the middle of the cross is measured in cm. The total length of the scale is 14 cm. Therefore, the minimum score is 0 and the maximum score is 14. The higher the score means that the participant is experiencing more symptoms."|8 weeks||||units on a scale||Standard Deviation|Mean
2641705|NCT01742949|Secondary|Subjective Dry Nose|"Measured through a visual analog scale. The patient has to mark a cross on the scale to indicate the severity of their symptoms. On the left side of the scale has not at all and on the right side of the scale has extremely, In order to analyze the data, a ruler from the start of the scale (Left side) to the middle of the cross is measured in cm. The total length of the scale is 14 cm. Therefore, the minimum score is 0 and the maximum score is 14. The higher the score means that the participant is experiencing more symptoms."|8 weeks||||units on a scale||Standard Deviation|Mean
2641706|NCT01742949|Secondary|Short Functional Outcomes of Sleep Questionnaire (FOSQ-10)|Collected through the Short Functional Outcomes of Sleep Questionnaire (FOSQ-10). The questionnaire has 10 questions which ask how daytime sleepiness has impacted their quality of life. Each question has a scale of 1 = yes extreme to 4 = No. Lower total score (min 10) means that the disease is affecting your quality of life while a higher total score (maximum 40) means that the disease is not affecting your quality of life.|8 weeks||||units on a scale||Standard Deviation|Mean
2641707|NCT01742949|Secondary|Epworth Sleepiness Score|Subjective measure of daytime sleepiness. There are 8 questions where the patient picks a scale of 0 = would never doze to 3 = high level of dozing for each questions. There can be a total score of 24. A score of 0-10 indicates normal daytime sleepiness, 11-12 mild excessive daytime sleepiness, 13-15 moderate excessive daytime sleepiness and 16-24 is severe excessive daytime sleepiness.|8 weeks||||units on a scale||Standard Deviation|Mean
2641708|NCT01742949|Primary|Adherence|Adherence with treatment per night averaged over total time period measured via internal software on the CPAP device and reported using InfoSmart™ software. The report will include all the supporting information recorded within the CPAP device.|8 weeks||||hours per night||Standard Deviation|Mean
2641709|NCT01742936|Primary|International Normalized Ratio (INR) Performed by Hospital Laboratory|Measuring the bloods ability to clot by the hospital's reference laboratory.|At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion)|Three cases of device error with CoaguChek®, 1 insufficient blood for measurement in the laboratory, and 1 communication failure during sending the blood sample to the laboratory occurred leaving 87 patients for analysis.|||ratio||Standard Deviation|Mean
2641710|NCT01742936|Primary|International Normalized Ratio (INR) on CoaguChek|Measuring the blood's ability to clot on a handheld monitor.|At end of surgery (an average of 2-4 hrs for cardiac bypass and 4-6 hrs. for spinal fusion)||||ratio||Standard Deviation|Mean
2641711|NCT01742897|Primary|Change From Baseline in Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) Score at Day 30|The WOMAC is a self administered, participant health related questionnaire consisting of three subscales (pain, stiffness and physical function). Pain subscale score ranges from 0-100 mm (0 mm=no pain to 100 mm=extreme pain); stiffness subscale score ranges from 0-100 mm (0 mm=no stiffness to 100 mm=extreme stiffness) and physical function subscale ranges from 0-100 mm (0 mm=no difficulty to 100 mm=extreme difficulty). The overall WOMAC score is the sum of the 3 subscale scores which ranges from 0-300 mm (0 mm=none to 300 mm=extreme/worst).|Baseline, Day 30|Intent-to-treat (ITT) analysis population included all participants regardless of their compliance with the protocol.|||Millimeter (mm)||95% Confidence Interval|Median
2641791|NCT01741688|Secondary|Median Duration of Treatment||Approximately 16 months||||months||Full Range|Median
2641792|NCT01741688|Secondary|Number of Participants With Dose Modifications at 6 Months||At 6 months||||participants|||Number
2641712|NCT01742832|Primary|Montgomery-Åsberg Depression Rating Scale (MADRS)|"The entire study will last 18 weeks. For the first 6 weeks, subjects will come in once every 2 weeks. For the next 4 weeks, subjects will come in once per week. For the next 6 weeks, subjects will come in once every 2 weeks. The final visit will come 2 weeks later for a total of 11 visits where the MADRS will be administered. Only the baseline and final (last observation) assessments for the outcome measure was used in determining results, thus these are the only values included.~MADRS scores range from 0-60, with higher scores indicating a greater level of severity. No subscales were used."|Baseline and final MADRS scores during the double-blind phase.||||units on a scale||Standard Deviation|Mean
2641713|NCT01742364|Other Pre-specified|Fluid Leakage on Skin at Injection Site||Immediately post-vaccination|For adults, the skin fluid deposition was estimated and categorized by the vaccinator (e.g., no wetness, damp skin, flow on skin, spray in air); for infants, volume was measured objectively and categorized by the filter paper technique (units in µl).|||participants|||Number
2641714|NCT01742364|Other Pre-specified|Diameter of Skin Bleb||Immediately post-vaccination||||participants|||Number
2641715|NCT01742364|Primary|Short Term Whole Blood Intracellular Cytokine Staining Assay for BCG-specific CD4 T-cells|"BCG-specific immunogenicity was tested in infants only, since they are the target study population and BCG immunogenicity in adults is known to be different from that in infants.~Utilizing a whole-blood intracellular cytokine staining (ICS) assay, we analyzed cytokine co-expression patterns by BCG-specific CD4 and CD8 T-cells. Briefly, 0.5 ml heparinized whole blood was incubated for 12 hours with BCG, no antigen or phytohemagglutinin (PHA) in the presence of anti-CD28 and anti-CD49d, with the last 5 hours including Brefeldin A prior to treating with BD FACS™ Lysing Solution and cryopreservation. Cells were batch-thawed, permeabilized with BD Perm/Wash™ buffer, and stained with fluorescent antibodies. At least 120,000 CD3+CD4+ T-cells were acquired for the no-antigen and BCG samples on a BD™ LSR II flow cytometer."|14 weeks post-vaccination|"Due to failed phlebotomy on 5 infants, results were not available for 2 participants in the Bioject ID Pen arm and for 3 participants in the Needle and syringe arm.~Immunogenicity was not measured for adults in the study."|||percentage responding to cytokines||Inter-Quartile Range|Median
2641716|NCT01742364|Primary|Short Term Whole Blood Intracellular Cytokine Staining Assay for BCG-specific CD4 (Cluster of Differentiation 4) T-cells|"BCG-specific immunogenicity was tested in infants only, since they are the target study population and BCG immunogenicity in adults is known to be different from that in infants.~Utilizing a whole-blood intracellular cytokine staining (ICS) assay, we analyzed cytokine co-expression patterns by BCG-specific CD4 and CD8 T-cells. Briefly, 0.5 ml heparinized whole blood was incubated for 12 hours with BCG, no antigen or phytohemagglutinin (PHA) in the presence of anti-CD28 and anti-CD49d, with the last 5 hours including Brefeldin A prior to treating with BD FACS™ Lysing Solution and cryopreservation. Cells were batch-thawed, permeabilized with BD Perm/Wash™ buffer, and stained with fluorescent antibodies. At least 120,000 CD3+CD4+ T-cells were acquired for the no-antigen and BCG samples on a BD™ LSR II flow cytometer."|10 weeks post-vaccination|"Due to failed phlebotomy on 5 infants, results were not available for 2 participants in the Bioject ID Pen arm and for 3 participants in the Needle and syringe arm.~Immunogenicity was not measured for adults in the study."|||percentage responding to cytokines||Inter-Quartile Range|Median
2641717|NCT01742364|Primary|Systemic Adverse Events|Systemic adverse events, solicited and unsolicited, including symptoms of lethargy, disrupted feeding patterns, fever, lymphadenopathy, rash, or any other physical abnormalities will be monitored for up to fourteen weeks following vaccination.|14 weeks||||Adverse events|||Number
2641718|NCT01742364|Primary|Injection Site Adverse Events (Following Injection)|Injection site adverse events including redness, swelling, induration, tenderness, ulceration, fluctuation , drainage, laceration, bruising, and scarring will be monitored for up to fourteen weeks following vaccination.|14 weeks||||Adverse events|||Number
2641719|NCT01742208|Secondary|Change From Day 1 in 3-hour Urinary Glucose Excretion Following a Mixed Meal Tolerance Test (MMTT) to Day 29: Expansion Groups|"A MMTT with frequent blood sample collection and with urine collection was performed on Day 1 and Day 29. Participants fasted (with the exception of water or non-caffeinated, calorie-free beverages) for at least 8 hours before the start of the MMTT and until the final blood sample was collected. Study drug was to be given within 15 minutes before liquid Boost® Original breakfast. Participants were asked to void immediately before blood sample 15 minutes before start of mixed meal and immediately after the 180-minute (3 hour) blood sample was collected, and all urine between the -15 minute and post-180-minute time points was collected for urine glucose calculation. Change was calculated by subtracting Day 1 value from Day 29 value. LS Means were based on a linear mixed model."|From 15 minutes before start of mixed meal until 180 min post start of mixed meal, on Day 1 and Day 29|Analysis was performed on ITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure. Data for this outcome measure was not analyzed for Pioneer Group participants.|||gram per 3 hour||95% Confidence Interval|Least Squares Mean
2641720|NCT01742208|Secondary|Change From Baseline in Percent Time Per Day Spent in Euglycemic Range (>=70 and <=180 mg/dL) Over Days 3 to 27 (Treatment Outpatient Period) Based on Continuous Glucose Monitoring|Baseline was calculated as the mean value from Day -6 to -2 for Expansion groups and from Day -6 to Day -3 for Pioneer Group. Change in percent time per day spent in euglycemic range was calculated by subtracting baseline value from Day 29 value. LS Means and CI for the Expansion groups were based on a mixed model. LS mean and CI for the Pioneer Group were based on the arithmetic treatment mean.|Baseline, Day 3 to Day 27|Analysis was performed on ITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure.|||percent time per day||95% Confidence Interval|Least Squares Mean
2641732|NCT01742078|Secondary|Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)|N-terminal propeptide of procollagen type 1 (P1NP) is a main bone formation marker. An increase of P1NP in serum reflects elevated anabolic activities of the bone. Percentage change in P1NP from baseline to post baseline time points was analyzed using the repeated-measures model.|Baseline (predose), Day 29 anytime, Day 85 anytime|All participants who received study drug and had evaluable results at the analyzed timepoints.|||percentage of change from baseline||90% Confidence Interval|Least Squares Mean
2641793|NCT01741688|Secondary|Median Dose at 6 Months||At 6 months|Number of participants remaining in the study at 6 months|||mg/kg of body weight||Full Range|Median
2641721|NCT01742208|Secondary|Change From Day 1 in 3-hour Plasma Glucose AUC (AUC0-3 h) Following a Mixed Meal Tolerance Test (MMTT) at Day 29: Expansion Groups|"A MMTT with frequent blood sample collection and with urine collection was performed on Day 1 and Day 29. Participants fasted (with the exception of water or non-caffeinated, calorie-free beverages) for at least 8 hours before the start of the MMTT and until the final blood sample was collected. Study drug was to be given within 15 minutes before liquid Boost® Original breakfast. The area under the plasma concentration-time curve (AUC) from time-zero to 3h postdose on Day 1 and Day 29 was calculated using the linear-up/log-down trapezoidal rule. Change was calculated by subtracting Day 1 value from Day 29 value. LS Means and CI were based on a linear mixed model."|Prior to start of mixed meal and 30, 60, 90, 120 and 180 min post start of mixed meal, on Day 1 and Day 29|Analysis was performed on ITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure. Data for this outcome measure was not analyzed for Pioneer Group participants.|||mg*h/dL||95% Confidence Interval|Least Squares Mean
2641722|NCT01742208|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Day 29|Baseline was defined as the last non-missing assessment prior to first dose of study drug. Change in FPG was calculated by subtracting baseline value from Day 29 value. LS Means and CI for the Expansion groups were based on a linear mixed repeated measures model.|Baseline, Day 29|Analysis was performed on ITT population.|||milligram/deciliter (mg/dL)||95% Confidence Interval|Least Squares Mean
2641723|NCT01742208|Secondary|Percent Change From Baseline in Total Daily Amount of Exogenous Insulin (Total Daily Bolus + Total Daily Basal) Required Calculated Over Days 3 to 27 (Treatment Outpatient Period)|Baseline was calculated as the mean value from Day -6 to -2 for Expansion groups and from Day -6 to Day -3 for Pioneer Group. Percent mean change from baseline was calculated as 100*(sum [each daily value - baseline]/ number of assessments)/baseline over Days 3 to 27. LS Means and CI for the Expansion groups were based on an ANCOVA model. LS Means and CI for the Pioneer Group were based on the arithmetic treatment mean.|Baseline, Day 3 to Day 27|Analysis was performed on ITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure.|||percent change||95% Confidence Interval|Least Squares Mean
2641724|NCT01742208|Secondary|Percent Mean Change From Baseline in Daily Bolus Amount of Exogenous Insulin Required at Each Meal Calculated Over Days 3 to 27 (Treatment Outpatient Period)|Baseline was calculated as the mean value from Day -6 to -2 for Expansion groups and from Day -6 to Day -3 for Pioneer Group. Percent mean change from baseline was calculated as 100*(sum [each daily value - baseline] / number of assessments)/baseline over Days 3 to 27. Percent change was calculated and is presented separately for each meal: i.e., breakfast, lunch and dinner. LS Means and CI for the Expansion groups were based on an ANCOVA model . LS Means and CI for the Pioneer Group were based on the arithmetic treatment mean.|Baseline, Day 3 to Day 27|Analysis was performed using ITT population. Here, number analyzed=participants with available data for this outcome measure.|||percent change||95% Confidence Interval|Least Squares Mean
2641725|NCT01742208|Primary|Percent Change From Baseline in Total Daily Bolus Amount of Exogenous Insulin Required Calculated Over Days 3 to 27 (Treatment Outpatient Period)|Baseline was calculated as the mean value from Day -6 to -2 for Expansion groups and from Day -6 to Day -3 for Pioneer Group. Percent mean change from baseline was calculated as 100*(sum [each daily value - baseline]/number of assessments)/baseline over Days 3 to 27. Least squares (LS) Means and confidence interval (CI) for the Expansion groups were based on an analysis of covariance (ANCOVA) model with covariates of baseline mean total bolus insulin, treatment group, factor used to stratify the randomization (screening A1C <= 8%, > 8%), and random effect of participant*treatment group. LS Means and CI for the Pioneer Group were based on the arithmetic treatment mean.|Baseline, Day 3 to Day 27|Analysis was performed using ITT population. Here, overall number of participants analyzed=participants with available data for this outcome measure.|||percent change||95% Confidence Interval|Least Squares Mean
2641726|NCT01742091|Secondary|Pharmacodynamics (PD): Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)|N-terminal propeptide of procollagen type 1 (P1NP) is a main bone formation marker. An increase of P1NP in serum reflects elevated anabolic activities of the bone. Change in P1NP from baseline to post baseline time points was analyzed using the repeated-measures model. Least squares (LS) mean was adjusted for baseline P1NP, treatment group, time (i.e. study day), and interaction between treatment group and time.|Predose, through Day 141|All participants who received study drug and had evaluable P1NP results at the analyzed time points.|||microgram per liter (ug/L)||90% Confidence Interval|Least Squares Mean
2641727|NCT01742091|Secondary|Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies||Predose (Day 1) and Postdose (Day 29, 85 and 141)|All participants who received study drug and had evaluable antibody results at the analyzed time points.|||participants|||Number
2641728|NCT01742091|Secondary|Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Day 85|A BMD test measures the amount of mineral (such as calcium) in a defined area of bone in grams per square centimeter (g/cm²). The least squares (LS) mean was adjusted for baseline lumbar spine BMD and treatment group.|Predose and Day 85|All participants who received study drug and had evaluable BMD results at the analyzed time points.|||gram per square centimeter (g/cm^2)||90% Confidence Interval|Least Squares Mean
2641729|NCT01742091|Secondary|Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, 0-tau) of LY2541546|Weekly AUC (AUC[0-tau]) during the first and last dosing interval for each participant receiving LY2541546 is reported.|Day 1 through Day 141|All participants who received study drug and had sufficient evaluable results for PK analysis.|||nanomole x hour per mililiter (nmol*h/mL||Standard Deviation|Mean
2641730|NCT01742091|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|"An SAE is any AE from this study that results in one of the following outcomes:~death~initial or prolonged inpatient hospitalization~a life-threatening experience (that is, immediate risk of dying)~persistent or significant disability/incapacity~congenital anomaly/birth defect~is considered significant by the investigator for any other reason"|Day 1 through Day 141|All participants who received study drug.|||participants|||Number
2641731|NCT01742078|Secondary|Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies|A validated assay designed to perform in the presence of LY2541546 was used for to assess development of antibodies.|Day 1: Predose, Day 29 anytime, Day 85 anytime|All participants who received study drug and had evaluable results at the analyzed time points.|||Participants|||Count of Participants
2641735|NCT01742078|Primary|Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration|"An SAE is any AE from this study that results in one of the following outcomes:~death~initial or prolonged inpatient hospitalization~a life-threatening experience (that is, immediate risk of dying)~persistent or significant disability/incapacity~congenital anomaly/birth defect~or is considered significant by the investigator for any other reason."|Day 1 through Day 85|All participants who received study drug.|||participants|||Number
2641736|NCT01742065|Secondary|Any CRC Screening|Binary indication of any CRC screening (fecal test, sigmoidoscopy, or colonoscopy) during the evaluation interval.|Any CRC screening complete within 12 months|Adult, age 50 to 74 years, clinic visit within 12 months of accrual, and due for CRC screening; no EHR evidence of completed FIT in past 11 months, flexible sigmoidoscopy in past 4 years, colonoscopy in past 9 years, an order for FIT in past 6 months or referral for sigmoidoscopy or colonoscopy in past year.|||Percentage completed any CRC screening||95% Confidence Interval|Least Squares Mean
2641737|NCT01742065|Primary|FIT Completion|Binary indication of FIT completion within 12 months or through August 3, 2015 (when usual care clinics received access to study tools). Proportion of completed FIT is represented below with a confidence interval of the difference in completed FIT.|Completed FIT kits sent back within 12 months|Adult, age 50 to 74 years, clinic visit within 12 months of accrual, and due for CRC screening; no EHR evidence of completed FIT in past 11 months, flexible sigmoidoscopy in past 4 years, colonoscopy in past 9 years, an order for FIT in past 6 months or referral for sigmoidoscopy or colonoscopy in past year.|||Model based percentage of participants||95% Confidence Interval|Least Squares Mean
2641738|NCT01741792|Secondary|CD8+ TEMRA Cells as a Percentage of All CD8+ T-Cells|Terminally differentiated effector memory T cells are characterized by the cell-surface expression of CD45RA but not CD197 and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of CD8+ T-cells||Standard Deviation|Mean
2641739|NCT01741792|Secondary|CD8+ Terminally Differentiated Effector Memory T-cells (TEMRA) Count|Terminally differentiated effector memory T cells are characterized by the cell-surface expression of CD45RA but not CD197 and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
2641740|NCT01741792|Secondary|CD8+ TEM Cells as a Percentage of All CD8+ T-Cells|Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of CD8+ T-cells||Standard Deviation|Mean
2641741|NCT01741792|Secondary|CD8+ Effector Memory T-Cell (TEM) Count|Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
2641742|NCT01741792|Secondary|CD8+ TCM Cells as a Percentage of All CD8+ T-Cells|Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of CD8+ T-cells||Standard Deviation|Mean
2641743|NCT01741792|Secondary|CD8+ TCM Cell Counts|Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||100 cells/µL||Standard Deviation|Mean
2641744|NCT01741792|Secondary|CD8+ Naive T-Cells as a Percentage of All CD8+ T-Cells|CD8+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of CD8+ T-cells||Standard Deviation|Mean
2641745|NCT01741792|Secondary|CD8+ Naive T-Cell Count|CD8+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
2641746|NCT01741792|Secondary|CD4+ TEM Cells as a Percentage of All CD4+ T-Cells|Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of CD4+ T-cells||Standard Deviation|Mean
2641747|NCT01741792|Secondary|CD4+ Effector Memory T-Cell (TEM) Count|Effector memory T cells are characterized by the lack of expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
2641748|NCT01741792|Secondary|CD4+ TCM Cells as a Percentage of All CD4+ T-Cells|Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of CD4+ T-cells||Standard Deviation|Mean
2641749|NCT01741792|Secondary|CD4+ Central Memory T-Cell (TCM) Count|Central memory T cells are characterized by the cell-surface expression of CD197 but not CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
2641750|NCT01741792|Secondary|CD4+ Naive T Cells as a Percentage of All CD4+ T-Cells|CD4+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of CD4+ T-cells||Standard Deviation|Mean
2641751|NCT01741792|Secondary|CD4+ Naive T Cell Count|CD4+ naive T-cell counts are native T-cells characterized by the cell-surface expression of CD197 and CD45RA and were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
2641752|NCT01741792|Secondary|CD4+ T-Cell to CD8+ T-Cell Ratio|CD4+ T-cells and CD8+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||ratio||Standard Deviation|Mean
2641753|NCT01741792|Secondary|CD19+ B-Cell to CD3+ T-Cell Ratio|CD19+ B-cells and CD3+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||ratio||Standard Deviation|Mean
2641754|NCT01741792|Secondary|CD8+ T-Cells as a Percentage of All Lymphocytes|CD8+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of lymphocytes||Standard Deviation|Mean
2641755|NCT01741792|Secondary|CD8+ T-Cell Count|CD8+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
2641756|NCT01741792|Secondary|CD4+ T-Cells as a Percentage of All Lymphocytes|CD4+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of lymphocytes||Standard Deviation|Mean
2641757|NCT01741792|Secondary|CD4+ T-Cell Count|CD4+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
2641758|NCT01741792|Secondary|CD3+ T-Cells as a Percentage of All Lymphocytes|CD3+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of lymphocytes||Standard Deviation|Mean
2641759|NCT01741792|Secondary|CD3+ T-Cell Count|CD3+ T-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
2641760|NCT01741792|Secondary|CD19+ B-Cells as a Percentage of All Lymphocytes|CD19+ B-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||percentage of lymphocytes||Standard Deviation|Mean
2641761|NCT01741792|Secondary|CD19+ B-Cell Count|CD19+ B-cell counts were analyzed by flow cytometry.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
2641762|NCT01741792|Secondary|Granulocyte Count||Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
2641763|NCT01741792|Secondary|Monocyte Counts||Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
2641764|NCT01741792|Secondary|Lymphocyte Counts|Lymphocyte counts were analyzed by differential blood count analysis.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
2641765|NCT01741792|Secondary|Leukocyte Counts|Leukocyte (white blood cells) counts were analyzed by differential blood count analysis.|Screening (Day -20 to Day 0), Day 1 pre-infusion, Days 8, 15, 29, 43, end of infusion (day 53), end of core study (day 87), and follow-up at 3, 6, 9, 12, 15, 18, 21 and 24 months after the first response assessment|Enrolled participants with available data at each time point. All participants are included in pre-infusion and follow-up data points, only those participants in Cohorts 1 and 3 who had the same treatment schedule of 9/28/112 µg/day step dosing are included in the infusion time points (day 8 through end of infusion).|||1000 cells/µL||Standard Deviation|Mean
2641766|NCT01741792|Secondary|Blinatumomab Steady State Serum Concentration|Blinatumomab serum levels were analyzed using a validated cluster of differentiation (CD)69 activation bioassay with a lower limit of quantification (LLOQ) of 50 pg/mL. Steady-state concentration (Css) was based on actual dose received, rather than based on cohort or time or day.|Cycle 1: predose; Day 3 and Day 8 (Css for 9 ug/day); Day 15 (Css for 28 ug/day); and Day 29, Day 43 and Day 57 (Css for 112 ug/day)|Pharmacokinetic (PK) data set (all participants who received any infusion of blinatumomab and had at least one PK sample collected).|||pg/mL||Standard Deviation|Mean
2641767|NCT01741792|Secondary|Number of Participants With Adverse Events|"Adverse events were evaluated for severity according to the grading scale provided in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.~An adverse event or suspected adverse drug reaction was considered serious if it resulted in one of the following outcomes:~Resulted in death;~Was life-threatening;~Required inpatient hospitalization or prolongation of existing hospitalization;~Resulted in persistent or significant incapacity or substantial disruption to conduct normal life functions;~Was a congenital anomaly or birth defect;~Was a medically important condition.~The Investigator used medical judgment to determine whether there was a causal relationship (ie, related [reasonably possible] or unrelated [not reasonably possible]) between an adverse event and blinatumomab."|From the first dose of blinatumomab until up to 30 days after the last dose or until the data cut-off date of 10 July 2014, whichever occurred first; the overall median duration of treatment exposure was 46.8 days.|Safety analysis set|||participants|||Number
2641768|NCT01741792|Secondary|Overall Survival (OS)|The time from the date of first blinatumomab infusion until death as a result of any cause. Patients still alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. For patients who withdrew their informed consent, only information until the date of withdrawal was analyzed.|From the first infusion of blinatumomab until the end of study; median time on follow-up for overall survival was 26.6 months.|Efficacy set|||months||95% Confidence Interval|Median
2641769|NCT01741792|Secondary|Progression-free Survival (PFS)|The time from the date of first blinatumomab infusion until the date of diagnosis of progression of lymphoma, the start date of new anti-tumor treatment (excluding any stem cell transplantation) or date of death, whichever is the earliest. Patients alive who did not have progression or new anti-tumor treatment (excluding any stem cell transplantation) were censored at last date of tumor assessment.|From first infusion of blinatumomab until the end of study; median time on follow-up for PFS was 27.0 months.|Efficacy set|||months||95% Confidence Interval|Median
2641770|NCT01741792|Secondary|Duration of Partial Response|The time from documentation of the first assessment of partial response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.|From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.|Efficacy set with a best overall response of PR during the first treatment cycle|||months||95% Confidence Interval|Median
2641771|NCT01741792|Secondary|Duration of Complete Response|The time from documentation of the first assessment of complete response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.|From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.|Efficacy set with a best overall response of CR during the first treatment cycle|||months||95% Confidence Interval|Median
2641772|NCT01741792|Secondary|Duration of Objective Response|The time from documentation of the first assessment of either partial or complete response until the start of new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death, whichever is the earliest event. A patient who did not have new anti-tumor treatment (excluding any stem cell transplantation), progression of disease, or death was censored at last tumor assessment date. Disease progression is defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.|From first infusion of blinatumomab until the end of study; median follow-up time for duration of response was 23.7 months.|Efficacy set with an overall objective response of CR or PR during the first treatment cycle|||months||95% Confidence Interval|Median
2641773|NCT01741792|Secondary|Percentage of Participants With a Best Overall Response of Partial Response|Response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Partial response is defined as regression (<50% decrease in size of masses) of measureable disease and no new sites.|During the first 8 weeks|Efficacy set|||percentage of participants||95% Confidence Interval|Number
2641774|NCT01741792|Secondary|Percentage of Participants With a Best Overall Response of Complete Response|Response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Complete response is defined as the disappearance of all evidence of disease.|During the first 8 weeks|Efficacy set|||percentage of participants||95% Confidence Interval|Number
2641794|NCT01741688|Secondary|Number of Participants Starting Tocilizumab After Failing Other Biologic Agents|Other biologic agents include anti-Tumor Necrosis Factor (TNF) antibody.|At baseline||||participants|||Number
2641795|NCT01741688|Secondary|Percentage of Participants Starting Tocilizumab After Prior and Baseline Disease-Modifying Anti-rheumatic Drugs (DMARDs) Exposure|"DMARDs exposure was evaluated for all participants. Prior DMARDs treatment includes participants, who were treated with DMARDs 6 months before being included in the study. DMARDs treatment at baseline includes participants, who were receiving DMARDs when they were included in the study and continued with this concomitant medication to tocilizumab."|At baseline||||percentage of participants|||Number
2641775|NCT01741792|Primary|Overall Objective Response Rate During Treatment Cycle 1|"Overall response within the first treatment cycle was assessed according to Cheson criteria by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Overall objective response rate (ORR) is the percentage of participants with a best overall response of complete response (CR) or partial response (PR).~Complete response is defined as the disappearance of all evidence of disease and partial response is defined as regression of measureable disease and no new sites."|During the first 8 weeks|Efficacy Set includes all participants who completed at least 7 days of infusion on the highest intended dose level.|||percentage of participants||95% Confidence Interval|Number
2641776|NCT01741701|Secondary|NonMotor Symptom Questionnaire (NMSQuest)|"The NMSQuest is a 30 item questionnaire with 30 yes/no questions. There is a total of 30 points with each yes score representing 1 point and therefore the higher the score the greater number of nonmotor symptoms present. The score can range from 0 to 30."|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
2641777|NCT01741701|Secondary|Geriatric Depression Scale (GDS)|The GDS is a measure of depression. The scale has 30 yes/no questions. Each question has a maximum score of 1 and a total possible score ranging from 0 to 30. The higher the score the greater the depression.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
2641778|NCT01741701|Secondary|Montreal Cognitive Assessment (MoCA)|The MoCA is an assessment of cognitive function. The total possible score ranges from 0 to 30 points with a lower score representing greater cognitive impairment.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
2641779|NCT01741701|Secondary|Parkinson's Disease Questionnaire - 39 (PDQ-39)|The PDQ-39 is a measure of quality of life in Parkinson's disease patients. It has 39 questions each with a response from 0-4 for a total of 156 points. The total score is calculated as a percentage so the scores of the 39 items are added and divided by 156 and multiplied by 100. The higher the score the worse quality of life.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.|||percentage of total possible score||Standard Deviation|Mean
2641780|NCT01741701|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score|The UPDRS has 3 subscales including Mentation (4 questions based on patient report with answers on a scale of 0-4, with a total of 16 points), Activities of Daily Living (13 questions based on patient report with answers on a scale of 0-4, with a total of 52 points) and Motor (27 questions based on clinician assessment on a scale of 0-4, with a total of 108 points). This measure examined the ADL + Motor subscales which have a total of 160 points with a higher score representing greater dysfunction.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
2641781|NCT01741701|Primary|Unified Parkinson's Disease Rating Scale (UPDRS) Total Score|The UPDRS has 3 subscales including Mentation (4 questions based on patient report with answers on a scale of 0-4, with a total of 16 points), Activities of Daily Living (13 questions based on patient report with answers on a scale of 0-4, with a total of 52 points) and Motor (27 questions based on clinician assessment on a scale of 0-4, with a total of 108 points). The total scores represents the sum of each of these sections for a total of 176 points with a higher score representing greater dysfunction.|4 months|Only subjects that completed the study were included in the efficacy analyses, those that withdrew were not included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
2641782|NCT01741688|Secondary|Disease Activity Score Based on 28 Joints (DAS28)|"The DAS28 is a measure of disease activity in rheumatoid arthritis (RA) and the number 28 refers to the 28 joints that are examined in this assessment. To calculate the DAS28 the following assessments are done: 1) count the number of swollen joints (out of the 28 [sw28]), 2) count the number of tender joints (out of the 28 [t28]), 3) measure Erythrocyte Sedimentation Rate (ESR), and 4) ask the participant to make a 'global assessment of health' (GH) indicated by marking a 10 cm line between very good and very bad.~The Score is developed under the follow formula:~DAS28(4) = 0.56*sqrt(t28) + 0.28*sqrt(sw28) + 0.70*Ln(ESR) + 0.014*GH Where, t=tender joints; sw=swollen joints; ESR= Erythrocyte Sedimentation Rate; GH=Global assessment of health score.~This score may range from 0 to 9.3, where a DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission."|At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks||||DAS28 score||Full Range|Median
2641783|NCT01741688|Secondary|Total Swollen Joint Count (SJC)||At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks||||Number of swollen joints/participant||Full Range|Median
2641784|NCT01741688|Secondary|Total Tender Joint Count (TJC)||At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks||||Number of tender joints/participant||Full Range|Median
2641785|NCT01741688|Secondary|Percentage of Participants on Tocilizumab Monotherapy at Study Entry||At baseline||||percentage of participants|||Number
2641786|NCT01741688|Secondary|Non-adherence Rate of Physician to the Recommended Dosing Regimen||Approximately 16 months|||||||
2641787|NCT01741688|Secondary|Time to Restoration of Initial Dosing Regimen||Approximately 16 months|||||||
2641788|NCT01741688|Secondary|Number of Participants Discontinued From Tocilizumab for Other Reasons|This variable measures the number of events not related to safety or efficacy leading to discontinuation of tocilizumab treatment.|Approximately 16 months||||participants|||Number
2641789|NCT01741688|Secondary|Percentage of Participants Discontinued From Tocilizumab for Lack of Efficacy|Efficacy variable that measures the rate of participants discontinued from tocilizumab due to lack of efficacy according to criteria of treating physician.|Approximately 16 months||||percentage of participants|||Number
2641798|NCT01741545|Secondary|Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities|Laboratory abnormalities were determined and graded using the Division of acquired immunodeficiency syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0. International Normalized Ratio (INR): >2.0*Upper limit of normal (ULN); Alanine aminotransferase (ALT) : >5*ULN; Aspartate aminotransferase (AST): >5*ULN; Prothrombin Time (PT): >1.50*ULN; Bilirubin (Total): >2.5*ULN; Triglycerides (fasting): >750 mg/dL.|After day 1 to to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)|All treated participants.|||Participants|||Count of Participants
2641799|NCT01741545|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death|AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug.|From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)|All treated participants.|||Percentage of participants|||Number
2641800|NCT01741545|Secondary|Percentage of Participants With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment|Flu-like symptoms were defined as pyrexia or chills or pain. Musculoskeletal symptoms were defined as arthralgia or myalgia or back pain.|After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)|mITT population.|||Percentage of participants||95% Confidence Interval|Number
2641801|NCT01741545|Secondary|Percentage of Participants With Treatment-Emergent Cytopenic Abnormalities On-Treatment|Cytopenic abnormalities were defined as anemia: Hemoglobin (Hb) <10 g/dL, and/or neutropenia: absolute neutrophils and bands (ANC) <750 mm^3, and/or thrombocytopenia: platelets <50,000 mm^3.|After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)|mITT population.|||Percentage of participants||95% Confidence Interval|Number
2641802|NCT01741545|Secondary|Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24)|SVR24 was defined as HCV RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.|Follow-up Week 24|mITT population.|||Percentage of participants||95% Confidence Interval|Number
2641803|NCT01741545|Secondary|Percentage of Participants With End of the Treatment Response (EOTR)|EOTR was defined as HCV RNA less than the lower limit of quantitation, target not detected at end of treatment.|End of the treatment (Week 12 for Cohort A, Week 24 for Cohort B)|mITT population.|||Percentage of participants||95% Confidence Interval|Number
2641804|NCT01741545|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 12.|Treatment Week 12|mITT population.|||Percentage of participants||95% Confidence Interval|Number
2641805|NCT01741545|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|RVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 4.|Treatment Week 4|mITT population.|||Percentage of participants||95% Confidence Interval|Number
2641806|NCT01741545|Primary|Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12|SVR12 was defined as HCV ribonucleic acid (RNA) less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.|Follow-up Week 12|The analysis was performed in modified intent to treat (mITT) population defined as participants meeting the response criteria over all treated participants.|||Percentage of participants||95% Confidence Interval|Number
2641807|NCT01741532|Secondary|Change in Level of Brain Iron|Neurodegeneration in patients with PKAN is associated with localized brain iron accumulation, with the highest amount of accumulation seen in the globus pallidus, one of the main areas for motor control. MRI R2* scans of this region were performed at baseline and Month 18 in a subset of patients who did not have a deep brain stimulation (DBS) device implanted, and for whom the use of anesthesia, if required, was deemed acceptable by the investigator.|Baseline to 18 Months||||Hz||Standard Error|Least Squares Mean
2641808|NCT01741532|Secondary|Change in Score on Pittsburgh Sleep Quality Index|"The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire that assesses sleep quality and disturbances over a 1-month time interval. A total of 19 individual items are used to generate 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction, and a score is generated that ranges from 0 (best) to 21 (worst)."|Baseline to 18 Months||||score on a scale||Standard Error|Least Squares Mean
2641809|NCT01741532|Secondary|Change in Score on Pediatric Quality of Life|The Pediatric Quality of Life (PedsQL) questionnaire is used to measure functional health and well-being from the patient's point of view. Separate versions of the questionnaire are available for children, young adults aged 18-25 years, and adults older than 25 years. Patients are asked to indicate how they have felt over the past month, and the scores of the 23 questions are used to generate an overall score that ranges from 0 (worst) to 100 (best).|Baseline to 18 Months||||score on a scale||Standard Error|Least Squares Mean
2641810|NCT01741532|Secondary|Change in Score on WeeFIM|The WeeFIM is the pediatric version of the Functional Independence Measure scale, and is used to assess physical and cognitive disability in three areas of daily living: self-care, mobility, and cognition. Within each area, items are scored according to the level of assistance required to perform that activity of daily living. A score of 1-2 indicates that the patient is completely dependent on a helper to perform the task, a score of 3-5 indicates that the patient is moderately dependent, and a score of 6-7 indicates that no help is required. The individual scores are summed to provide a global score from 18 (worst) to 126 (best).|Baseline to 18 Months||||score on a scale||Standard Error|Least Squares Mean
2641821|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|12-month follow up||||units on a scale||Standard Error|Mean
2641811|NCT01741532|Secondary|Change in Score on Functional Independence Measure|The Functional Independence Measure (FIM) scale is used to assess physical and cognitive disability in three areas of daily living: self-care, mobility, and cognition. Within each area, items are scored according to the level of assistance required to perform that activity of daily living. A score of 1-2 indicates that the patient is completely dependent on a helper to perform the task, a score of 3-5 indicates that the patient is moderately dependent, and a score of 6-7 indicates that no help is required. The individual scores are summed to provide a global score from 18 (worst) to 126 (best).|Baseline to 18 Months||||score on a scale||Standard Error|Least Squares Mean
2641812|NCT01741532|Secondary|Change in Score on Unified Parkinson's Disease Rating Scale|The Unified Parkinson's Disease Rating Scale (UPDRS) is the major rating scale used to assess severity of symptoms of Parkinson's disease, some of which are similar to those of PKAN. The UPDRS subscales used in this study were Part I: Mentation, Behavior and Mood, scored from 0 (best) to 16 (worst); Part II: Activities of Daily Living, scored from 0 (best) to 52 (worst); Part III: Motor Examination, scored from 0 (best) to 108 (worst); and Part VI: Schwab and England Activities of Daily Living Scale, scored from 0% (worst) to 100% (best).|Baseline to 18 Months||||score on a scale||Standard Error|Least Squares Mean
2641813|NCT01741532|Primary|Score on Patient Global Impression of Improvement at End of Study|The Patient Global Impression of Improvement (PGI-I) is a global index that assesses the response of a condition to a therapy by asking patients to rate their current state relative to their state at baseline. It consists of a 7-point rating scale, where 1=very much improved, 2= much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Month 18||||score on a scale||Standard Error|Least Squares Mean
2641814|NCT01741532|Primary|Change in Score on Barry-Albright Dystonia Scale|The Barry-Albright Dystonia (BAD) scale rates severity of dystonia (sustained muscle contractions causing twisting and repetitive movements or abnormal postures) in 8 body regions. The individual scores are summed to provide a total score ranging from 0 to 32, with higher scores indicating greater severity. The co-primary endpoint in this study was the change from baseline to Month 18 in BAD total score.|Baseline to 18 Months||||score on a scale||Standard Error|Least Squares Mean
2641815|NCT01741480|Secondary|Mortality|Death during hospitalization will be used to determine the presence of this outcome.|Patients will be asessed for the secondary outcome measure during an average of 28 days..||2019-10-31|10/2019||||
2641816|NCT01741480|Primary|ICU Transfer|Patients transferred to the ICU from a general hospital ward will be assessed as having met the outcome.|Patients will be assessed for the primary outcome measure during their hospital with an average of 14 days.||||participants|||Number
2641817|NCT01741454|Primary|Ureteral Stent Symptom Questionnaire Score Up to 24 Hours After Stent Removal|The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized.|Up to 24 hours after stent removal. Removal will occur 5 to 7 days after insertion.|same|||score on a scale||Standard Deviation|Mean
2641818|NCT01741454|Primary|Ureteral Stent Symptom Questionnaire Score 5-7 Days Post-stent Insertion|The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized.|5-7 days post-stent insertion|same|||score on a scale||Standard Deviation|Mean
2641819|NCT01741454|Primary|Ureteral Stent Symptom Questionnaire Score|The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized.|42-48 hours post-stent insertion|Same|||score on a scale||Standard Deviation|Mean
2641820|NCT01741454|Primary|Ureteral Stent Symptom Questionnaire Score Up to 24 Hours Prior to Stent Insertion|The ureteral stent symptom questionnaire contains 36 items from the 5 subscales: urinary index (11-items, total range of scores 11-54, The range of the mean score is 1-4.9), pain (8-items, total range of scores 5-27. Two items are not included in the calculation. The range of the mean score is 0.83-4.5), general health (6-items, total range of scores 4-28. The range of the mean score is 0.67-4.67), work (if stent influence patients work; 7-items, total range of scores 3-15. Four items are not included in the calculation. The range of the mean score is 1-5), and sexual matters (4-items, total range of scores 2-10. Two items are not included in the calculation. The range of the mean score is 1-5). In all cases, higher scores indicate worse outcomes. The score for each subscale is summed and divided by the number of items on the subscale. The group mean for each subscale is reported, the score is not normalized.|Up to 24 hours prior to stent insertion|For all sub-scales, we reported the average score, the higher values suggest worse outcomes.|||score on a scale||Standard Deviation|Mean
2641822|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|6-month follow up||||units on a scale||Standard Error|Mean
2641823|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|3-month follow up||||units on a scale||Standard Error|Mean
2641824|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
2641825|NCT01741350|Primary|Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., If asked, I am confident I could demonstrate how to use male condom and female condoms correctly) and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior."|Baseline||||units on a scale||Standard Error|Mean
2641826|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|12-month follow up||||units on a scale||Standard Error|Mean
2641827|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|6-month follow up||||units on a scale||Standard Error|Mean
2641828|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|3-month follow up||||units on a scale||Standard Error|Mean
2641829|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
2641830|NCT01741350|Primary|Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., Most people who are important to me think I should always use condoms during sexual intercourse in the next three months) and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior."|Baseline||||units on a scale||Standard Error|Mean
2641831|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|12-month follow up||||units on a scale||Standard Error|Mean
2641832|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|6-month follow up||||units on a scale||Standard Error|Mean
2641833|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|3-month follow up||||units on a scale||Standard Error|Mean
2641834|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
2641835|NCT01741350|Primary|Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., Always using condoms during sexual intercourse during the next three months would be good) and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior."|Baseline||||units on a scale||Standard Error|Mean
2641836|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|12-month follow up||||units on a scale||Standard Error|Mean
2641837|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|6-month follow up||||units on a scale||Standard Error|Mean
2641838|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|3-month follow up||||units on a scale||Standard Error|Mean
2641839|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
2641840|NCT01741350|Primary|Sex-related HIV-risk Reduction Knowledge (0-1)|"Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge."|Baseline||||units on a scale||Standard Error|Mean
2641841|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|12-month follow up||||units on a scale||Standard Error|Mean
2641842|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|6-month follow up||||units on a scale||Standard Error|Mean
2641843|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|3-month follow up||||units on a scale||Standard Error|Mean
2641844|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
2641845|NCT01741350|Primary|Condom Use (0-4)|"Participants were asked: In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex? and rated on scale of 0 to 4, with indicating greater condom use."|Baseline||||units on a scale||Standard Error|Mean
2641846|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|12-month follow up||||percentage of correct steps||Standard Error|Mean
2641847|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|6-month follow up||||percentage of correct steps||Standard Error|Mean
2641848|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|3-month follow up||||percentage of correct steps||Standard Error|Mean
2641849|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|Immediately Post-Intervention, at 4 weeks||||percentage of correct steps||Standard Error|Mean
2641850|NCT01741350|Primary|Male Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.|Baseline||||percentage of correct steps||Standard Error|Mean
2641851|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|12-month follow up||||percentage of correct steps||Standard Error|Mean
2641852|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|6-month follow up||||percentage of correct steps||Standard Error|Mean
2641853|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|3-month follow up||||percentage of correct steps||Standard Error|Mean
2641854|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|Immediately Post-Intervention, at 4 weeks||||percentage of correct steps||Standard Error|Mean
2641855|NCT01741350|Primary|Female Condom Skills (0-100%)|Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.|Baseline||||percentage of correct steps||Standard Error|Mean
2641856|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|12-month follow up||||units on a scale||Standard Error|Mean
2642142|NCT01738919|Primary|Extension Deficit in the Affected Distal Interphalangeal Joint.|Extension deficit measured in degrees, using goniometer. (The lacking extension from at straight stretched finger = degrees of extension deficit)|6 month||||degrees extension deficit||95% Confidence Interval|Mean
2641857|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|6-month follow up||||units on a scale||Standard Error|Mean
2641858|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|3-month follow up||||units on a scale||Standard Error|Mean
2641859|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
2641860|NCT01741350|Primary|Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., How hard would it be for you to always use condoms) and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior."|Baseline||||units on a scale||Standard Error|Mean
2641861|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|12-month follow up||||units on a scale||Standard Error|Mean
2641862|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|6-month follow up||||units on a scale||Standard Error|Mean
2641863|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|3-month follow up||||units on a scale||Standard Error|Mean
2641864|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
2641865|NCT01741350|Primary|Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months) and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior."|Baseline||||units on a scale||Standard Error|Mean
2641866|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|12-month follow up||||units on a scale||Standard Error|Mean
2641867|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|6-month follow up||||units on a scale||Standard Error|Mean
2641868|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|3-month follow up||||units on a scale||Standard Error|Mean
2641869|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
2641870|NCT01741350|Primary|Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)|"Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., I plan to always use clean needles if I shoot up drugs during the next six months) and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior."|Baseline||||units on a scale||Standard Error|Mean
2641871|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles)."|12-month follow up||||units on a scale||Standard Error|Mean
2641872|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge)."|6-month follow up||||units on a scale||Standard Error|Mean
2641873|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge)."|3-month follow up||||units on a scale||Standard Error|Mean
2641874|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge)."|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
2641875|NCT01741350|Primary|Drug-related HIV-risk Reduction Knowledge (0-1)|"Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles) and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge)."|Baseline||||units on a scale||Standard Error|Mean
2641876|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use.|12-month follow up||||units on a scale||Standard Error|Mean
2641877|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use.|6-month follow up||||units on a scale||Standard Error|Mean
2641878|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use.|3-month follow up||||units on a scale||Standard Error|Mean
2641879|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use.|Immediately Post-Intervention, at 4 weeks||||units on a scale||Standard Error|Mean
2641880|NCT01741350|Primary|Safer Drug Use (0-4)|Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use.|Baseline||||units on a scale||Standard Error|Mean
2641881|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|12-month follow up||||Percentage of correct steps||Standard Error|Mean
2641882|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|6-month follow up||||Percentage of correct steps||Standard Error|Mean
2641883|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|3-month follow up||||Percentage of correct steps||Standard Error|Mean
2641884|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|Immediately Post-Intervention, at 4 weeks||||Percentage of correct steps||Standard Error|Mean
2641885|NCT01741350|Primary|Demonstrated Drug Risk Reduction Skills (0-100%)|Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.|Baseline||||Percentage of correct steps||Standard Error|Mean
2641886|NCT01741272|Secondary|Complications|Incidence of any surgical or medical complications will be prospectively documented.|2 & 6 weeks, 3, 6, 12, 24 months|37 subjects (17 Early Mobilization, 20 Standard Rehabilitation) had non-re-tear complications. 5 subjects reported more than one complication.|||participants|||Number
2641887|NCT01741272|Secondary|Abduction Strength Using the Power Component of the Constant Score|The Constant Score is the most widely used shoulder evaluation questionnaire in Europe and is a shoulder specific instrument. The score is a combination of an objective physical examination (65 points) and a subjective patient self evaluation (35 points). The physical examination component includes a range of motion assessment (forward elevation, lateral elevation, internal rotation, and external rotation) worth a total of 40 points (maximum of 10 points for each motion). The remaining 25 points are attributed to the strength assessment, where patients are awarded one point for each pound of pull that the patient can resist in abduction. Therefore the total possible score on the Constant score is 100 points (best possible score = 100. In this case only the power component was used therefore the best score is 25.|Baseline, 24 months||||units on a scale||Inter-Quartile Range|Mean
2641888|NCT01741272|Secondary|WORC Questionnaire|Health related quality of life was measured using the Western Ontario Rotator Cuff Index (WORC). It is a 21-item disease specific questionnaire representing five quality of life domains (physical symptoms, sports and recreation, work, lifestyle and emotions). Each response is marked on a 100mm line in a VAS format with a maximum raw score of 2100, where zero represents the best and 2100 the worst score. This score is transformed to a 0-100 format, with 100 representing full shoulder function.|Baseline, 6, 12, 24 months||||units on a scale||Inter-Quartile Range|Mean
2641889|NCT01741272|Secondary|Pain Questionnaire|Shoulder pain was assessed using a visual analogue scale (VAS) where zero equals no pain and 10 is the worst possible pain at rest and with activity. Two-way repeated-measures analysis of variance (ANOVA) compared pain between groups over time.|Baseline, 2 weeks, 6 weeks, 3, 6, 12, 24 months||||centimeters||Standard Deviation|Mean
2641890|NCT01741272|Primary|Change in Range of Motion (ROM)From Baseline to 24 Months|"Two-way repeated-measures analysis of variance (ANOVA) compared shoulder ROM between groups over time. Standing: Active flexion, scaption, abduction, extension, internal rotation (vertebral level).~Supine Lying: Active and passive flexion, abduction, external rotation (arm at side), external rotation (arm at 90 degrees abduction), internal rotation (arm at side), internal rotation (arm at 90 degrees abduction),and horizontal adduction."|Baseline, 6 weeks, 3, 6, 12, 24 months||||degrees||Standard Deviation|Mean
2642866|NCT01732835|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||mm Hg||Standard Deviation|Mean
2641891|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #9|On a 0-10 scale, how satisfied are you with the results of your pain treatment with 0 being extremely dissatisfied and 10 being extremely satisfied. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
2641892|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #8|On a 0-10 scale, were you allowed to participate in decisions about your pain treatment as much as you wanted to with 0 being not at all and 10 being entirely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
2641893|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #7|Select the percentage (from 0%-100%) of pain relief you received from all medical and non-medical treatments in the first 24 hours. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||percentage of pain relieved||Standard Error|Mean
2641894|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #6d|On a 0-10 scale, how severe was your dizziness where 0 is not at all and 10 is extremely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
2641895|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #6c|On a 0-10 scale, how severe was your itching where 0 is none and 10 is severe. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
2641896|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #6b|On a 0-10 scale, how severe was your drowsiness where 0 is none and 10 is severe. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
2641897|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #6a|On a scale of 0-10, what was the severity of your nausea where 0 is none and 10 is severe. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
2641898|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #5d|How much, on a scale of 0-10, did the pain cause you to feel helpless where 0 is not at all and 10 is extremely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
2641899|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #5c|How much, on a scale of 0-10, did the pain cause you to feel frightened where 0 is not at all and 10 is extremely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
2641900|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #5b|On a scale of 0-10, how much did pain cause you to feel depressed where 0 is not al all and 10 is extremely. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
2641901|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #5a|On a scale of 0-10, how much did the pain cause you to feel anxious where 0 is not at all anxious and 10 is extremely anxious. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
2641902|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #4d|How much, on a scale of 0-10, did pain interfere with staying asleep where 0 is does not interfere and 10 is completely interferes. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
2643392|NCT01729208|Primary|Change in Refractive Error Relative to Baseline|Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline.|12 months||||Diopters|Eyes|Standard Deviation|Mean
2641903|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #4c|How much, on a 0-10 scale, did pain interfere with falling asleep where 0 is does not interfere and 10 is completely interferes. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
2641904|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #4b|How much, on a 0-10 scale, did pain interfere with doing activities out of bed (walking, sitting in chair, standing at sink) where 0 is does not interfere and 10 is completely interferes. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
2641905|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #4a|How much, on 0-10 scale, did pain interfere with doing activities in bed (turning, sitting up, repositioning) where 0 is does not interfere and 10 is completely interferes. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
2641906|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #3|How often were you in severe pain in the first 24 hours (percentage 0-100%). 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||percentage of time||Standard Error|Mean
2641907|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #2|On 0-10 scale, indicate the worst pain you had in first 24 hours. 0 represents no pain and 10 represents the worst pain possible. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
2641908|NCT01741259|Secondary|American Pain Society Patient Outcome Questionnaire #1|Please indicate on 0-10 scale the least pain you had in first 24 hours. 0 represents no pain and 10 represents the worst pain possible. 122 patients in the Meperidine PCEA no basal group completed their questionnaires while 118 in the Meperidine PCEA with basal group completed a questionnaire. Some patients did not answer all the questions on the questionnaire, if a question was left blank, it was not analyzed for that patient but the rest of the questionnaire was included.|Survey day epidural stopped||||units on a scale||Standard Error|Mean
2641909|NCT01741259|Secondary|Total Drug Dose|Pharmacy will generate a report of the drug total from the pump on return to pharmacy.|48 hours post-op or when the epidural is stopped||||milligrams of drug per hour||Standard Deviation|Mean
2641910|NCT01741259|Secondary|Adverse Outcomes|Adverse outcomes such as seizures or respiratory depression will be reported to anesthesia personnel by nursing if they occur. Patients are monitored for respiratory rate and sedation every 1 hour for 24 hours, then every 2 hours for 24 hours. Pulse, blood pressure, and neurocirculatory checks are performed every 2 hours for 24 hours and then every 4 hours per our nursing protocol.|36-48 hours post-op (until the epidural is stopped)||||participants|||Number
2641911|NCT01741259|Secondary|Inadequate Analgesia|Patients routinely get scheduled ibuprofen as an adjunct to the epidural infusion. The record will be reviewed to see if ketorolac is substituted for ibuprofen or other pain medications such as acetaminophen either alone or in combination with oxycodone or other narcotic pain relievers are administered. The record will also be reviewed if an epidural is discontinued earlier than the morning of the second post-operative day to find out if inadequate analgesia was the cause.|36-48 hours post-op (until the epidural is stopped)||||participants|||Number
2641912|NCT01741259|Secondary|Dysphoria|The incidence of dysphoria will be captured when a nurse calls the anesthesia team to alert them. This information is tracked on the physician rounding sheet. The record will also be reviewed if an epidural is discontinued earlier than the morning of the second post-operative day to find out if dysphoria was the cause.|36-48 hours post-op (until epidural is stopped)||||participants|||Number
2641913|NCT01741259|Secondary|Pruritus|The incidence of pruritus will be estimated by the administration of diphenhydramine or nalbuphine during the study period as recorded in the patient record.|36-48 hours post-op (until the epidural is stopped)||||participants|||Number
2641914|NCT01741259|Secondary|Nausea and Vomiting|The incidence of nausea and vomiting will be estimated by the administration of ondansetron during the study period as recorded in the patient record.|36-48 hours post-op (until epidural is stopped)||||participants|||Number
2641915|NCT01741259|Primary|Verbal Pain Score With Movement|Verbal Pain Score on a 0-10 scale is recorded by the nurse at 0, 4, 8, 12, 16, 20, 24, 28, 32, 36,40, 44, and 48 hours after transfer to the post-partum floor. On this scale, 0 represents no pain at all and 10 represents the worst pain imaginable. Because we were relying on nurses to capture this data in the course of normal patient care, scores within 1 hour before or after the goal time were accepted. For each patient, the average of all pain scores was taken and this was considered to be the average pain score while the epidural meperidine was being given.|36-48 hours post-op (until epidural is stopped)||||units on a scale||Standard Deviation|Mean
2641935|NCT01740713|Primary|Cmax|Maximum concentration reached in plasma. Secondary pharmacokinetic parameter derived on the basis of the individual predicted concentration vs. time profiles, through the pop-PK model.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)||||microM||Inter-Quartile Range|Median
2642735|NCT01734434|Primary|Percentage of Subjects Delivering at a Non-study Site.|The percentage of subjects who delivered at a non-study site relative to the number of enrolled subjects was calculated.|Baseline until average of 24 weeks|Analysis was done on FAS.|||Percentages of subjects||95% Confidence Interval|Number
2641916|NCT01741012|Secondary|SLE Disease Activity Flares|SELENA-SLEDAI measurements > or = to 2 The SELENA/SLEDAI is a validated instrument which is used to score disease activity and define flares with the SELENA-SLEDAI score range being 0-105, with 0 indicating inactive disease.The SELENA/SLEDAI instrument consists of 24 items, each with a definition of activity; there are 16 clinical items and 8 laboratory items. Although there are no set standards, inactive or minimal disease is generally reflected by a SELENA/SLEDAI score of less than or equal to 2 while more than minimally active disease is reflected by a score of >2.|1,61,66,181,186,211,330 days|Number of patients who had a lupus flare defined by a SELENA -SLEDAI > or = to 2|||Participants|||Count of Participants
2641917|NCT01741012|Secondary|Seroconversion by HPV Serotypes (HPV 6, HPV 11, HPV 16, HPV 18)as Assessed by Geometric Mean Antibody Titer|1. The percentage of HPV naive women who seroconverted by HPV serotypes was measured using Geometric Mean Titers for HPV serotypes HPV 6, HPV 11, HPV 16, HPV 18|Baseline (prevaccine) neutralizing anti HPV antibody titers at visit 1 and anti HPV antibody titers at 1 month post 3rd vaccine shot which is at 7 months in the study.|The percentage of Human Papilloma Virus (HPV) naive women for HPV serotypes 6, 11, 16 and 18 that seroconverted|||percentage of particpants|||Number
2641918|NCT01741012|Primary|Number of Non Vaccine Adverse Events|the number of non vaccine adverse events|1,61,66,181,186,211,330 days|Number of non vaccine adverse events|||events|||Number
2641919|NCT01741012|Primary|Frequency of Participants With Adverse Events|Frequency of participants with Vaccine site reactions, Frequency of participants with Non Vaccine Adverse Events,|1,61,66,181,186,211,330 days||||Participants|||Count of Participants
2641920|NCT01740817|Secondary|Extracellular Signal-regulated Kinase (ERK) Phosphorylation in Muscle|Forty eight hrs after lipid or saline infusion, muscle ERK phosphorylation will be measured by western blot. The results are compared to determine whether lipid infusion increases muscle ERK phosphorylation compared to saline infusion. Saline mean was used to normalize the data for both arms.|48 hr following lipid or saline infusion, pre-clamp||||densitometry value||Standard Error|Mean
2641921|NCT01740817|Secondary|TLR4 Messenger Ribonucleic Acid (mRNA) in Muscle|"Forty eight hrs after lipid or saline infusion, muscle TLR4 mRNA levels will be measured by RT-PCR. The results are compared to determine whether lipid infusion increases muscle TLR4 mRNA expression compared to saline infusion.~Saline mean was used to normalize the data for both arms."|48 hr following lipid/saline infusion, pre-clamp||||ng TLR4 mRNA/ng Actin mRNA||Standard Error|Mean
2641922|NCT01740817|Primary|Muscle Insulin Sensitivity-M Value|"Forty eight hrs after lipid or saline infusion, muscle insulin sensitivity will be measured by insulin clamp. The results are compared to determine whether lipid infusion reduces muscle insulin sensitivity compared to saline infusion..~The M value is defined as the exogenous glucose infusion rate at steady state (i.e, when the exogenous glucose infusion rate is equal to the rate of whole body glucose disposal)."|48 hr after lipid/saline infusion||||mg/kg.min||Standard Error|Mean
2641923|NCT01740726|Other Pre-specified|Child's Behavior Checklist - Parent Version (CBCL-P)|Completed by parents to describe the child's behavioral and emotional difficulties. Scores reflect observed problems and level of adaptive functioning.|18 wks., 30 wks., 42 wks.|Data are not available for analysis.||||||
2641924|NCT01740726|Other Pre-specified|Adolescent Longitudinal Interval Follow-up Evaluation (A-LIFE)|Semi-structured interview that assesses psychiatric symptoms, treatments, and functional outcomes in the time period that has elapsed since the previous assessment and tracks change over time.|18 wks., 30 wks, 42 wks|Data are not available for analysis.||||||
2641925|NCT01740726|Secondary|Change in Hope Based on Children's Hope Scale (CHS)|Assesses self-perception of ability to set and work toward goals.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.|Data are not available for analysis.||||||
2641926|NCT01740726|Secondary|Change in Suicidal Ideation Based on Suicidal Ideation Questionnaire (SIQ)|Assesses seriousness of suicidal intent.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.|Data are not available for analysis.||||||
2641927|NCT01740726|Secondary|Change in Anxiety From Baseline Based on Multidimensional Anxiety Scale for Children (MASC)|Measures anxiety symptom severity.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.|Data are not available for analysis.||||||
2641928|NCT01740726|Secondary|Change in Behaviors From Baseline Based on Behavioral Activation for Depression Scale (BADS)|Assesses behavioral changes on 4 subscales: Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.|Data are not available for analysis.||||||
2641929|NCT01740726|Secondary|Overall Improvement and Change in Symptom Severity From Baseline Based on Clinical Global Impression - Improvement and Severity (CGI-I, CGI-S)|Clinician's rating of symptom severity and improvement since baseline.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.|Data are not available for analysis.||||||
2641930|NCT01740726|Primary|Change in Depressive Symptoms From Baseline Based on Children's Depression Rating Scale - Revised (CDRS-R)|Interview-based measure, completed with both the parent and child, that assesses depression severity.|Baseline, 9 wks., 18 wks., 30 wks., 42 wks.|Data are not available for analysis.||||||
2641931|NCT01740726|Primary|Change in Depressive Symptoms From Baseline Based on Beck Depression Inventory, 2nd Edition (BDI-II)|Self-report measure, completed by the child, that assesses depressive symptom severity. The BDI-II total score ranges from 0 to 63, with a higher score indicating a higher level of depression. Change is the difference between the 42 week score and the baseline score.|Baseline, 42 weeks||||units on a scale|||Number
2641932|NCT01740713|Secondary|Adverse Events|All the medical occurrences that started after the administration of the drug|from drug administration up to 8 days post treatment||||participants|||Number
2641933|NCT01740713|Primary|Cmin|Minimum plasma concentration. Secondary pharmacokinetic parameter derived on the basis of the individual predicted concentration vs. time profiles, through the pop-PK model.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)||||microM||Inter-Quartile Range|Median
2641934|NCT01740713|Primary|Css|Plasma concentration reached at steady state. Secondary pharmacokinetic parameter derived on the basis of the individual predicted concentration vs. time profiles, through the pop-PK model.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)||||microM||Inter-Quartile Range|Median
2642901|NCT01732796|Primary|Comparisons of SVR12 Rates Across Treatment Arms|Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.|12 Week (post-treatment)|FAS|||Percentage of participants|||Number
2641937|NCT01740713|Primary|Tmax|Time at which the maximum concentration (Cmax) is reached. Secondary pharmacokinetic parameters such as Cmax, Min, Tmax, Css and AUC (0-8h) were derived based on the individual predicted concentration vs. time profiles.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)||||hour||Inter-Quartile Range|Median
2641938|NCT01740713|Primary|V/F|volume of distribution after oral administration. The parameter was estimated through a population pharmacokinetic model, during which concentration data obtained after single oral dose ( at 3 dose levels) of DFP in patients aged from 1 month to less than 6 years of age|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)||||litres||Standard Error|Mean
2641939|NCT01740713|Primary|AUC (0-8h)|Area under concentration versus time curve from 0 to 8 h post dosing. Secondary pharmacokinetic parameter derived on the basis of the individual predicted concentration vs. time profiles, through the pop-PK model.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)||||micromol*h/L||Inter-Quartile Range|Median
2641940|NCT01740713|Primary|CL/F|Plasma clearance after oral administration. The parameter was estimated through a population pharmacokinetic model, during which concentration data obtained after single oral dose ( at 3 dose levels) of DFP in patients aged from 1 month to less than 6 years of age.|Day 1 of single dose treatment (6 sampling time range: from predose up to 8h post first administration)||||litre/h||Standard Error|Mean
2641941|NCT01740440|Secondary|To Evaluate the Subject's Satisfaction With BMR Face Treatment at 6 Weeks and 12 Weeks (Subject Self- Assessment).|The Subject Satisfaction Assessment Scale is a 5 point scale where a subject rates their satisfaction level as Very Satisfied, Satisfied, No Opinion, Unsatisfied or Very Unsatisfied.|6 weeks, 12 weeks|23 out of 30 subjects that were enrolled in the study were statistically analyzed. 3 subjects were lost to follow-up and 4 subjects had to be excluded from analysis due to protocol violations|||percentage of subjects|||Number
2641942|NCT01740440|Secondary|To Evaluate Overall Facial Improvement Assessed Live by the Investigator and Subjects Including the Global Aesthetic Improvement Scale (GAIS) at 6 Weeks Compared to Baseline|"Evaluate the efficacy of the Efficacy will be assessed by overall facial improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS).~The Global Aesthetic Improvement Scale is a five-grade subjective test. The physician and patient independently describe the degree of improvement in facial appearance. Possible responses were (1) Significantly marked improvement, (2) marked improvement, (3) moderate improvement, (4) slight improvement, (5) no improvement.~For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range 0-4)."|6 weeks|23 out of 30 subjects that were enrolled in the study were statistically analyzed. 3 subjects were lost to follow-up and 4 subjects had to be excluded from analysis due to protocol violations|||units on a scale||Full Range|Mean
2641943|NCT01740440|Primary|Evaluate Overall Facial Improvement Assessed Live by the Investigator and Subjects Using the Global Aesthetic Improvement Scale (GAIS) at 12 Weeks Compared to Baseline.|"Evaluate the efficacy of the Efficacy will be assessed by overall facial improvement assessed live by the Investigator and a subject assessment of facial appearance including the Global Aesthetic Improvement Scale (GAIS).~The Global Aesthetic Improvement Scale is a five-grade subjective test. The physician and patient independently describe the degree of improvement in facial appearance. Possible responses were (1) Significantly marked improvement, (2) marked improvement, (3) moderate improvement, (4) slight improvement, (5) no improvement.~For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range 0-4)."|12 weeks|23 out of 30 subjects that were enrolled in the study were statistically analyzed. 3 subjects were lost to follow-up and 4 subjects had to be excluded from analysis due to protocol violations.|||Scores on a Scale||Full Range|Mean
2641944|NCT01740427|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs; All Causalities)|An AE is any untoward medical occurrence in a clinical investigation patient administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening; requires hospitalization; results in persistent or significant disability or in congenital anomaly/birth defect. Severity will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0.|From the participant randomization up to 28 days after last dose of study drug, up to 2.5 years|AT population = ITT population because all the participants randomized were treated with study drugs per study design.|||Percentage of Participants|||Number
2641945|NCT01740427|Secondary|Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy -Breast (FACT-B)|FACT is a modular approach to assess participant health-related quality of life using a 'core' set of questions (FACT-G) as well as a cancer site-specific module. The FACT-G is a 27-item compilation of general questions divided into 4 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The FACT-B consisted of the FACT-G (27-item) and a breast-specific module: a 10-item instrument designed to assess participant concerns relating to breast cancer. For all questions, participants were asked to respond to a five-level scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. FACT-B total score = Physical Well-Being + Social/Family Well-Being + Emotional Well-Being + Functional Well-Being + Breast Cancer Subscale. As each of the items ranges from 0-4, the range of possible scores is 0-144, with 0 being the worst possible score and 144 the best.|From Baseline up to 2.5 years|Patient Reported Outcome (PRO) Analysis Set is a subset of ITT participants, who had both baseline and at least one follow-up PRO assessment.|||Units on a scale||95% Confidence Interval|Mean
2641946|NCT01740427|Secondary|Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index|The EuroQol EQ-5D is a 6-item instrument designed to assess health status in terms of a single index value or utility score. It contains 5 descriptors of current health state (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having 3 levels of function (1=no problem, 2=some problem, and 3=extreme problem). The scores on the 5 descriptors are summarized to create a single summary score. An overall utility score is calculated based on these domains, with a range score from 0 (worse health scenario) to a maximum of 1.0 (best health scenario).|From Baseline up to 2.5 years|Patient Reported Outcome (PRO) Analysis Set is a subset of ITT participants, who had both baseline and at least one follow-up PRO assessment.|||Units on a scale||95% Confidence Interval|Mean
2641947|NCT01740427|Secondary|Observed Plasma Trough Concentration (Ctrough) at Steady-State|Summary of Plasma Palbociclib Within-Patient Mean Steady-State Trough Concentrations.|0 hour (predose) on Day 14 of cycles 1 and 2|Pharmacokinetic analysis set was a subset of AT participants, who were treated with Palbociclib and had at least one measured plasma concentration.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2641948|NCT01740427|Secondary|Corrected QT Interval (QTc)|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Percentage of participants with post-baseline maximum absolute values and maximum increase from baseline were summarized for the safety analysis population.|For safety monitoring triplicate ECGs were obtained at 0 hour (pre-dose) on Day 1 of Cycle 1, Day 14 of Cycles 1 and Cycle 2, then on Day 1 of Cycles 4, 7, and 10. ECGs beyond Cycle 10 were performed as clinically indicated|The AT population or safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.|||Percentage of participants|||Number
2641949|NCT01740427|Secondary|Corrected QT Interval (QTc) Time-matched Change From Baseline on Cycle 1 Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and sent to a central laboratory for blinded manual adjudication. The average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR), by Bazette's formula (QTcB = QT divided by square root of RR) and corrected QT interval according to study-specific criteria (QTcS). Time-matched change from baseline values were reported for QTc analysis population.|Time-matched triplicate ECGs were collected at 0 (predose), 2, 4, 6 and 8 hours on Day 0 and on Cycle1 Day14|QTc analysis set is a subset of as treated (AT) population who were in Group 1; their QTc was used to study the effect of palbociclib on QT interval via serial triplicate ECGs with PK draws; and who had ≥ 1 pair of time-matched Day 0 and palbociclib postdose (Cycle1 Day14) measurements.|||msec||90% Confidence Interval|Least Squares Mean
2641950|NCT01740427|Secondary|Tumor Tissue Biomarkers, Including Genes (eg, Copy Numbers of CCND1, CDKN2A), Proteins (eg, Ki67, pRb), and RNA Expression (eg, cdk4, cdk6): Protein Biomarker Analyses by Using Immunohistochemistry Are Presented|"PFS survival by biomarker status by Investigator assessment. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.~Positive is defined as H-Score ≥1 and negative as H-Score <1. H-Score is calculated as the sum of the % of cells at each level of staining intensity (0, 1+, 2+, and 3+) multiplied by the staining intensity value: H-Score = (% at 0)*0 + (% at 1+)*1 + (% at 2+)*2 + (% at 3+)*3. H-Score values range from 0 to 300.~ER stands for estrogen receptor and Rb stands for retinoblastoma susceptibility gene product."|From randomization until end of treatment (up to approximately 24 Months)|ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
2641951|NCT01740427|Secondary|Disease Control (DC)/Clinical Benefit Response (CBR)|DC is defined as the overall CR, PR, or stable disease (SD) ≥24 weeks according to the RECIST version 1.1. Disease Control Rate (DCR) is defined as the patients with CR, PR, or SD ≥24 weeks relative to all randomized participants. Participants who do not have on-study radiographic tumor reevaluation, who received anti-tumor treatment, a best response of SD≥24 weeks, or who died, progressed,or dropped out for any reason prior to achieving reaching a CR or PR and a best response of SD≥24 weeks was counted as non-responders in DCR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. SD: neither sufficient shrinkage nor increase to qualify for disease progression|From randomization until end of treatment (up to approximately 2.5 years)|ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2641952|NCT01740427|Secondary|Duration of Response (DR)|DR is defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurs first. If tumor progression data included more than 1 date, the first date will be used. DR was calculated as [the date response ended (i.e. date of PD or death) - first CR or PR date + 1)]/30.4. DR would only be calculated for the subgroup of patients with an objective tumor response. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions.The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.|From randomization until end of treatment (up to approximately 2.5 years)|Patients who had tumor response with CR or PR during study. A total of 206 and 85 patients had objective response in the palbociclib plus letrozole and placebo plus letrozole arms, respectively.|||Months||95% Confidence Interval|Median
2641962|NCT01740401|Primary|The Anti-tumor Activity of the Combination of Low Dose Cyclophosphamide and CTLA-4 Blockade Using Objective Response Rate (ORR)|Objective response rate (ORR) using mWHO RC. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|12 weeks||||Participants|||Count of Participants
2641963|NCT01740388|Other Pre-specified|Bulbar Conjunctival Injection|Bulbar conjunctival injection measured on a scale of 0-3 where 0 = Normal, 1 = Mild, 2 = Moderate and 3 = Severe|At each follow-up visit (Visit 1, Visit 2 and Visit 3)||||participants|||Number
2641953|NCT01740427|Secondary|Objective Response: Patients With Measurable Disease at Baseline as Assessed by the Investigator|The OR is defined as the overall CR or PR according to the RECIST v1.1. ORR is defined as proportion of patients with CR or PR relative to all randomized patients with measurable disease at baseline. Patients who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.|From randomization until end of treatment (up to approximately 2.5 years)|Patients who had measurable disease at baseline. A total of 338 and 171 patients had measurable disease at baseline in the palbociclib plus letrozole and placebo plus letrozole arms, respectively.|||Percentage of participants||95% Confidence Interval|Number
2641954|NCT01740427|Secondary|Objective Response as Assessed by the Investigator|Objective Response (OR) is defined as the overall complete response (CR) or partial response (PR) according to the RECIST v1.1. Objective Response Rate (ORR) is defined as proportion of patients with CR or PR relative to all randomized patients with measurable disease at baseline. Patients who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment, or who died, progressed/ dropped out for any reason prior to reaching a CR or PR were counted as non-responders in the assessment of ORR. Per RECIST v1.1, CR: Complete disappearance of target lesions with exception of nodal disease. All target nodes must decrease to normal size (short axis <10mm). PR: ≥30% decrease under baseline of the sum of diameters of all target measurable lesions.The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions. Stable Disease: neither sufficient shrinkage nor increase to qualify for disease progression.|From randomization until end of treatment (up to approximately 2.5 years)|ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2641955|NCT01740427|Primary|Progression-Free Survival (PFS) as Assessed by the Investigator.|PFS is defined as the time from the date of randomization to the date of the first documentation of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death due to any cause in the absence of documented PD, whichever occurs first. If tumor progression data include more than 1 date, the first date will be used. PFS (in months) will be calculated as (first event date − randomization date +1)/30.4. Progression is defined using RECIST v1.1, as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions, or the appearance of new lesions.|From randomization date to date of first documentation of progression OR death (up to approximately 2.5 years)|ITT population or full analysis set included all participants who were randomized, with study medication, regardless of whether participants received study medication or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
2641956|NCT01740414|Other Pre-specified|Pain Intensity|"15-item shortened form of the McGill Pain Questionnaire (Melzack, 1987) that is used to assess the sensory and affective dimensions of the pain experienced Participants describe their experience of pain by choosing among a series of possible answers (None [score=1], Mild [score=2], Moderate [score=3], or Severe [score=4]). They were asked to describe the pain as Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot-Burning, Aching, Heavy, Tender, Splitting, Tired-Exhausting, Sickening, Fearful, and Punishing-Cruel. Scores were added across all 15 items to generate a sum score, which ranged between 15 and 60."|42 days||||units on a scale||Standard Error|Mean
2641957|NCT01740414|Secondary|Positive Subjective Effects to Oxycodone|"Participants are shown a 100-mm line and asked to indicate on that line the extent to which they agree with the descriptor of the drug effect such as Liking/Liked the Drug. On this visual analog scale participants were instructed that the Left/ 0 mm point on the line represents not at all, while the right/100 mm point represents Extremely."|42 days||||units on a scale||Standard Deviation|Mean
2641958|NCT01740414|Primary|Drug Self-administration Breakpoint|Participants are allowed to perform an operant task (click on a mouse) in order to receive a dose drug under investigation (oxycodone dose 0 mg, 15 mg, or 30 mg). The drug breakpoint is the maximum number of responses (mouse clicks) the participant was willing to make to receive the drug. Within the context of abuse liability studies, larger breakpoints represent greater abuse potential of a drug.|42 days||||Clicks on a computer mouse||Standard Error|Mean
2641959|NCT01740401|Secondary|T Regulatory Cell Profile in Peripheral Blood|Peripheral blood taken at baseline/various therapeutic time points/possibly maintenance cycles to evaluate T regulatory cells identified, serially monitored by polychromatic flow cytometry using FoxP3+/CD4+/CD127low/CD25hi markers.|Week 60|Primary Endpoint not met, study terminated, data not collected||||||
2641960|NCT01740401|Other Pre-specified|Tumor-specific T Cell Responses Will be Measured in a Subset of Patients Who Have Biopsy Accessible Tumor and Have Tumor Biopsies Taken.|One of the tumor punch biopsy will be put in formalin for paraffin-embedding. The other tumor punch biopsy will be processed to obtain lysates to be used as antigens for the T cell assays. Two tumor punch biopsies (4mm in diameter) will be obtained before and after therapy (baseline and week 12, and optional during weeks 24, 36, and 48) if patients have accessible tumors.|Week 48|Primary Endpoint not met, study terminated, data not collected||||||
2641961|NCT01740401|Secondary|Progression-free Survival|Progression-free survival is measured from date of entry to date of 1st documented evidence of recurrence, confirmation of PD, or death (whichever is 1st). T regulatory cells are measured on D1 (pre CTX) & D3 of each cycle.|Week 60|Primary Endpoint not met, study terminated, data not collected||||||
2641964|NCT01740388|Other Pre-specified|Ocular Conjunctival Discharge|Ocular conjunctival discharge measures on a scale of 0-3 where 0 = Absent, 1 = Mild, 2 = Moderate and 3 = Severe|At each follow-up visit (Visit 1, Visit 2 and Visit 3)|Analysis population is only Subjects with non-missing data, Ocular Discharge Evaluated on the Baseline-Designated Study Eye|||participants|||Number
2641966|NCT01740388|Secondary|Clinical Resolution|Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%|Visit 3 (Day 6, 7, or 8)|Analysis population is only Subjects with non-missing data, Clinical Resolution (LOCF [Last Observation Carried Forward])|||participants|||Number
2641967|NCT01740388|Primary|Microbial Eradication|Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%|Visit 2 (Day 4 or 5)|Analysis population is only Subjects with non-missing data, Microbial Eradication (LOCF [Last Observation Carried Forward])|||participants|||Number
2641968|NCT01740388|Primary|Clinical Resolution|Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%|Visit 2 (Day 4 or 5)|Analysis population is only Subjects with non-missing data, Clinical Resolution (LOCF [Last Observation Carried Forward])|||participants|||Number
2641969|NCT01740362|Primary|Renal Clearance (CL R)|Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time.|0 (Pre-dose) to 12 hours post-dose, 12 to 24 hours post-dose|Analysis set included all participants who received study medication.|||mL/min||Standard Deviation|Mean
2641970|NCT01740362|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose|Analysis set included all participants who received study medication.|||hours||Standard Deviation|Mean
2641971|NCT01740362|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose|Analysis set included all participants who received study medication.|||hours||Full Range|Median
2641972|NCT01740362|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose|Analysis set included all participants who received study medication.|||ng/mL||Standard Deviation|Mean
2641973|NCT01740362|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (Pre-dose), 0.5, 1, 1.5, 2, 4, 8, 10, 12, 16, 24, 48 hours post-dose|Analysis set included all participants who received study medication.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
2641974|NCT01740323|Secondary|Fatigue|The secondary outcome to be measured will be the change in fatigue (as measured by the Multidimensional Fatigue Inventory [MFI] total score) after six weeks of treatment with daily placebo or Meriva. The MFI is a 20-item scale designed to evaluate fatigue. Respondents use a scale ranging from 1 to 5 for each item to indicate how statements regarding fatigue represent their experiences. The range of scores is from a minimum of 20 and a maximum of 100. Higher total scores correspond with more acute levels of fatigue.|Baseline, 6 weeks following completion of XRT||||score on a scale||Standard Deviation|Mean
2641975|NCT01740323|Primary|Plasma C-reactive Protein (CRP) Measured in mg/L|The primary outcome to be measured will be the change in plasma CRP after six weeks of treatment with daily placebo or Meriva.|Baseline, 6 weeks following completion of XRT||||mg/L||Standard Deviation|Mean
2641976|NCT01740323|Primary|Plasma IL-6 Measured in pg/ml|The primary outcome to be measured will be the change in plasma IL-6 after six weeks of treatment with daily placebo or Meriva.|Baseline, 6 weeks following completion of XRT||||pg/mL||Standard Deviation|Mean
2641977|NCT01740323|Primary|Plasma IL-1ra Measured in pg/ml|The secondary outcome to be measured will be the change in plasma IL-1ra (in pg/ml) after six weeks of treatment with daily placebo or Meriva. Plasma IL-1ra is a downstream mediator of NF-kB DNA binding and has been associated with fatigue in breast cancer patients.|Baseline, 6 weeks following completion of XRT|Assays were not analyzed due to lack of funding.||||||
2641978|NCT01740323|Primary|Plasma sTNFR2 Measured in pg/ml|The secondary outcome to be measured will be the change in plasma sTNFR2 (in pg/ml) after six weeks of treatment with daily placebo or Meriva. Plasma sTNFR2 is a downstream mediator of NF-kB DNA binding and has been associated with fatigue in breast cancer patients.|Baseline, 6 weeks following completion of XRT|Assays were not analyzed due to lack of funding.||||||
2641979|NCT01740323|Primary|Plasma TNF-alpha|The secondary outcome to be measured will be the change in plasma TNF-alpha after six weeks of treatment with daily placebo or Meriva. Plasma TNF-alpha is a downstream mediator of NF-kB DNA binding and has been associated with fatigue in breast cancer patients.|Baseline, 6 weeks following completion of XRT||||ng/well||Standard Deviation|Mean
2641980|NCT01740323|Primary|PBMC NF-kB DNA Binding Measured in ng/Well|The primary outcome to be measured will be the change in NF-kB DNA binding (measured in peripheral blood mononuclear cells as ng/well) after six weeks of treatment with daily placebo or Meriva. NF-kB DNA binding and has been associated with fatigue in breast cancer patients.|Baseline, 6 weeks following completion of XRT||||ng/well||Standard Deviation|Mean
2641981|NCT01740297|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where grade 1 = mild AE, grade 2 = moderate AE, grade 3 = severe AE, grade 4 = life-threatening or disabling AE and grade 5 = death related to AE.~The investigator assessed whether each AE was possibly related to talimogene laherparepvec (T-VEC) and/or ipilimumab (Imab).~Note that one participant in the Phase 2 Ipilimumab Alone group was incorrectly noted as having an AE leading to discontinuation of T-VEC which was discovered and corrected after this analysis was conducted."|From first dose of study treatment until 30 days after the last dose; median duration of treatment was 14.7, 9.1, and 21.1 weeks in each treatment group respectively.|All participants who received ≥ 1 dose of investigational product (talimogene laherparepvec or ipilimumab).|||participants|||Number
2641982|NCT01740297|Secondary|Phase 2: Kaplan-Meier Estimate of Percentage of Participants Alive at Month 12 and 24|The overall survival estimates at month 24 data were not mature as most participants had not been followed for 24 months at the time of data cutoff.|Months 12 and 24; The median (Q1, Q3) follow-up time from randomization to the data cutoff date for the analysis was 80.6 (58.3, 106.3) weeks.|All participants randomized in phase 2|||percentage of participants||95% Confidence Interval|Number
2642957|NCT01732640|Secondary|Correlate Standard Imaging Pre and Post Treatment|To correlate the response with standard imaging CT/MRI and FDG PET pre and post treatment.|5 Years|Patients were taken off study before the full 5 years could be completed, therefore data was not collected for this outcome measure.||||||
2641983|NCT01740297|Secondary|Phase 2: Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death from any cause. Participants without an event were censored at the last date they were known to be alive. Participants with a vital status obtained after the data cut-off were censored at the date cut-off date.|From randomization until the data cut-off date of 23 August 2016; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2|||months||95% Confidence Interval|Median
2641984|NCT01740297|Secondary|Phase 2: Resection Rate|Resection rate was defined as the percentage of participants who had surgical procedures for melanoma that resulted in a partial reduction or complete eradication of all previously unresectable cutaneous or visceral metastatic disease. Surgical procedures for melanoma with palliative intent (eg, for pain control) in the presence of disease progression were not considered resection.|From randomization until the data cut-off date of 23 August 2016; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2|||percentage of participants||95% Confidence Interval|Number
2641985|NCT01740297|Secondary|Phase 2: Progression-free Survival|Progression-free survival was measured from the date of randomization to the date of disease progression (as measured by modified irRC) or death on or before the data cutoff date, whichever occurred first. Participants who had no disease progression and did not die while on study were censored at the last disease assessment date.|From randomization until the data cut-off date of 23 August 2016; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2|||months||95% Confidence Interval|Median
2641986|NCT01740297|Secondary|Phase 2: Duration of Response|Duration of response was calculated only for participants with an objective response per modified irRC and was defined as the time from first confirmed objective response (CR or PR) to confirmed disease progression per the modified irRC or death, whichever was earlier. Responders who did not have an event of death or disease progression were censored at their last evaluable tumor assessment date.|Tumor response was assessed every 12 weeks until disease progression; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|Participants randomized in phase 2 with a confirmed CR or PR.|||months||95% Confidence Interval|Median
2641987|NCT01740297|Secondary|Phase 2: Time to Response|Time to confirmed response (TTR) was defined as the time from randomization to the date of the first confirmed CR or PR per modified irRC criteria. Participants who did not have a confirmed CR or PR were censored at their last evaluable tumor assessment date.|Tumor response was assessed every 12 weeks until disease progression; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2|||months||95% Confidence Interval|Median
2641988|NCT01740297|Secondary|Phase 2: Durable Response Rate|Durable response rate (DRR) was defined as the percentage of participants with a duration of response (best response of CR or PR) per modified irRC of at least 6 months. Duration of response is the time from the first confirmed CR or PR to confirmed disease progression per the modified irRC or death, whichever occurs earlier.|Tumor response was assessed every 12 weeks until disease progression; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2|||percentage of participants||95% Confidence Interval|Number
2641989|NCT01740297|Secondary|Phase 2: Disease Control Rate|"Disease control rate (DCR) was defined as the percentage of participants with a best overall response of CR, PR or SD based on investigator assessment according to the modified irRC.~CR: Complete disappearance of all lesions and no new lesions; any pathological lymph nodes reduced in short axis to <10 mm.~PR: Decrease in tumor burden ≥ 50% relative to baseline. SD: Not meeting criteria for CR or PR, in absence of PD and no earlier than 77 days after the date of enrollment/randomization.~CR and PR must have been confirmed at 2 consecutive assessments ≥ 4 weeks apart."|Tumor response was assessed every 12 weeks until disease progression; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2|||percentage of participants||95% Confidence Interval|Number
2641990|NCT01740297|Secondary|Phase 2: Best Overall Response|"Best overall response was categorized in descending order as a complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) or unevaluable (UE) based on investigator assessment according to the modified irRC.~CR: Complete disappearance of all lesions and no new lesions; Any pathological lymph nodes reduced in short axis to <10 mm.~PR: Decrease in tumor burden ≥ 50% relative to baseline. PD: Increase in tumor burden ≥ 25% relative to nadir. SD: Not meeting criteria for CR or PR, in absence of PD and no earlier than 77 days after the date of enrollment/randomization.~CR, PR and PD must have been confirmed at 2 consecutive assessment ≥ 4 weeks apart.~Assessments occurring after the start of the first subsequent anticancer therapy or removal of a lesion were not included."|Tumor response was assessed every 12 weeks until disease progression; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2|||participants|||Number
2641991|NCT01740297|Secondary|Phase 1b: Objective Response Rate|"Objective response rate is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) according to the modified immune-related response criteria (irRC) assessed by the investigator. Tumors were examined clinically and by computed tomography (CT) or magnetic resonance imaging (MRI).~CR: Complete disappearance of all lesions and no new lesions; Any pathological lymph nodes reduced in short axis to <10 mm.~PR: Decrease in tumor burden ≥ 50% relative to baseline. Response must have been confirmed by a repeat, consecutive assessment ≥ 4 weeks from the date first documented. Participants who did not have any follow-up tumor assessments were regarded as non-responders."|Tumor response was assesed every 12 weeks until disease progression; median follow-up time was 148.4 weeks.|All phase 1b participants who received ≥ 1 dose of investigational product (talimogene laherparepvec or ipilimumab).|||percentage of participants||95% Confidence Interval|Number
2642006|NCT01740128|Secondary|Change in Subjective Pain as Determined by McGill Pain Questionnaire (Short Form).|Change between baseline and Evaluation #2 in McGill Pain Questionnaire (Subjective Domain). Total scale 0-45, lower is better.|Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Incomplete analysis due to dropouts before post-testing, and due to incomplete outcome assessment by Investigating team.|||units on a scale||Standard Deviation|Mean
2643393|NCT01729156|Secondary|VLDL-TG Oxidation|VLDL-TG oxidation assessed by 14C carbon dioxide (CO2) in exhaled breath|90 days||||percentage of 14C-VLDL||Standard Deviation|Mean
2641992|NCT01740297|Primary|Phase 2: Objective Response Rate|"Objective response rate is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) according to the modified immune-related response criteria (irRC) assessed by the investigator. Tumors were examined clinically and by computed tomography (CT) or magnetic resonance imaging (MRI).~CR: Complete disappearance of all lesions and no new lesions; Any pathological lymph nodes reduced in short axis to <10 mm.~PR: Decrease in tumor burden ≥ 50% relative to baseline. Response must have been confirmed by a repeat, consecutive assessment ≥ 4 weeks from the date first documented. Participants who did not have any follow-up tumor assessments were regarded as non-responders."|Tumor response was assessed every 12 weeks until disease progression; median follow-up time was 57.7 weeks and 68.1 weeks in each treatment group respectively.|All participants randomized in phase 2|||percentage of participants||95% Confidence Interval|Number
2641993|NCT01740297|Primary|Phase 1b: Number of Participants With Dose-limiting Toxicities|"A DLT was defined as any toxicity related to study drug which met any of the following criteria based on Common Terminology Criteria for Adverse Events version 3.0:~treatment-related non-laboratory adverse events (AE) ≥ grade 4~≥ grade 4 immune-mediated dermatitis~≥ grade 4 immune-mediated endocrinopathy (except autoimmune thyroiditis)~≥ grade 3 immune-mediated enterocolitis~≥ grade 3 immune-mediated hepatitis (except grade 3 that resolved to grade 1 or baseline within 28 days of onset)~≥ grade 3 immune-mediated neuropathy~≥ grade 3 other immune-mediated AEs including hemolytic anemia, angiopathy, myocarditis, pericarditis, temporal arteritis, or vasculitis, autoimmune thyroiditis (except grade 3 that resolved to grade 1 or baseline within 28 days of onset), blepharitis, conjunctivitis, episcleritis, iritis, scleritis, or uveitis, pancreatitis, meningitis, arthritis or polymyalgia rheumatic, nephritis, pneumonitis, psoriasis or leukocytoclastic vasculitis."|The DLT evaluation period was 6 weeks from the initial administration of ipilimumab (week 6 to 12).|All phase 1b participants who received ≥ 1 dose of investigational product (talimogene laherparepvec or ipilimumab).|||participants|||Number
2641994|NCT01740206|Secondary|mYPAS Measurement in Patients Not Receiving Midazolam|"modified Yale Preoperative Anxiety Scale (mYPAS), which is commonly used for assessing anxiety during the induction of anesthesia, administered to patients who did not receive midazolam prior to anesthesia induction.~Assessment items: Activity (A) 1-4 points (A = score/4), Vocalizations (V) 1-6 points (V = score/6), Emotional expressivity (E) 1-4 points (E = score/4), State of arousal (S) 1-4 points (S = score/4), Use of parent (U) 1-4 points (U = score/4). Final score = [(A + V + E + S +U)/5] x 100. Higher score = more anxiety."|Day 1|Of the 48 subjects analyzed, 38 subjects did not receive midazolam prior to their surgical procedure.|||scores on a scale||Inter-Quartile Range|Median
2641995|NCT01740206|Secondary|mYPAS Measurement in Patients Receiving Midazolam|"modified Yale Preoperative Anxiety Scale (mYPAS), which is commonly used for assessing anxiety during the induction of anesthesia, administered to patients who received midazolam prior to anesthesia induction.~Assessment items: Activity (A) 1-4 points (A = score/4), Vocalizations (V) 1-6 points (V = score/6), Emotional expressivity (E) 1-4 points (E = score/4), State of arousal (S) 1-4 points (S = score/4), Use of parent (U) 1-4 points (U = score/4). Final score = [(A + V + E + S +U)/5] x 100. Higher score = more anxiety."|Day 1|Of the 48 subjects analyzed, 10 subjects received midazolam prior to their surgical procedure.|||scores on a scale||Inter-Quartile Range|Median
2641996|NCT01740206|Secondary|Mean Blood Pressure|Mean blood pressure prior to anesthetic induction|Day 1||||mmHg||Standard Deviation|Mean
2641997|NCT01740206|Secondary|Diastolic Blood Pressure|Diastolic blood pressure prior to anesthetic induction|Day 1||||mmHg||Standard Deviation|Mean
2641998|NCT01740206|Secondary|Systolic Blood Pressure|Systolic blood pressure prior to anesthetic induction|Day 1||||mmHg||Standard Deviation|Mean
2641999|NCT01740206|Primary|Heart Rate|Heart rate prior to anesthetic induction|Day 1||||BPM||Standard Deviation|Mean
2642000|NCT01740154|Primary|Changes in Motor Evoked Potential (MEP) by TMS|TMS illustrates the changes in corticospinal excitability occurring in association with fatigue. Central muscle evoked response (MEP) will be elicited using transcranial magnetic stimulation (TMS) using single stimulus pulses applied to the scalp overlying the primary motor cortex.|Baseline and 28 days|Data not collected||||||
2642001|NCT01740154|Primary|Change in EMG Amplitude and Power Frequency|EMG amplitude will increase (for low-intensity SC) and mean power frequency (MPF) decrease with muscle fatigue. The EMG signals recorded during the SC, its amplitude and MPF will be analyzed to determine their changes at the end vs. beginning of the SC. If the sunitinib results in minimal muscular fatigue, the amount of EMG increase and MPF decrease will be reduced in the 2nd compared with those the 1st session.|Baseline and 28 days|Data not collected||||||
2642002|NCT01740154|Primary|Changes of Muscular (Peripheral) Fatigue Maximal Twitch Force (MTF)|The MTF will be elicited by supramaximal-intensity electrical stimulation of the muscle before and after the sustained contraction (SC). If the muscle is fatigued at the end of the SC, the MTF will be reduced because the ability of muscle to generate force declines with fatigue. If the sunitinib treatment results in minimal muscular fatigue, the MTF will not have as much reduction in the 2nd as that in the 1st session.|Baseline and 28 days|Data not collected||||||
2642003|NCT01740128|Secondary|Changes From Baseline in Survey: Spinal Cord Injury - Spasticity Evaluation Tool (SCI-SET)|Change between baseline and Evaluation #2 in SCI-SET score. Range of scores -105 to +105. Higher is better.|Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Incomplete analysis due to dropouts before post-testing, and due to incomplete outcome assessment by Investigating team.|||units on a scale||Standard Deviation|Mean
2642004|NCT01740128|Secondary|Change From Baseline in Soleus H-reflex Facilitation.|Change between baseline and Evaluation #2 in soleus H-reflex facilitation by transcranial magnetic stimulation (TMS). Short-interval 0-20ms.|Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Incomplete analysis due to dropouts before post-testing, and due to lack of soleus H-reflex in several subjects.|||percentage of control reflex size||Standard Error|Mean
2642005|NCT01740128|Secondary|Change From Baseline in Endpoint Excursion and Directional Control Parameters Achieved During Seated Limits of Stability Testing.|"Seated posturography performed using the Limits of Stability module of the Smart EquiTest apparatus (Neurocom) while seated. Directional Control measure."|Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Incomplete analysis due to dropouts before post-testing.|||Percentage of perfect path to target||Standard Error|Mean
2642007|NCT01740128|Secondary|Change From Baseline in Total Number of Steps Taken by Both Feet During Seated 10-second Step Test.|Change between baseline and Evaluation #2 in steps taken during 10-second step test.|Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Low number of participants able to perform seated steps at baseline.|||steps||Standard Error|Mean
2642008|NCT01740128|Secondary|Change From Baseline in Walking Index for Spinal Cord Injury II (WISCI II) Scale.|Change between baseline and Evaluation #2 in WISCI II score. Scores range 0-20, higher is better.|Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Insufficient number of participants able to walk at baseline. Measure not recorded by Investigating team.||||||
2642009|NCT01740128|Secondary|Change in Gait Speed on 10-meter Walk Test.|Change between baseline and Evaluation #2 in gait speed during 10-meter walk test.|Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Insufficient number of participants able to walk at baseline.|||meters per second||Standard Deviation|Mean
2642010|NCT01740128|Secondary|Change in Leg Spasticity on Modified Ashworth Scale|Change between baseline and Evaluation #2 in modified Ashworth Scale. 0-4 score, lower is better.|Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Incomplete analysis due to dropouts before post-testing, and due to incomplete outcome assessment by Investigating team.|||units on a scale||Standard Deviation|Mean
2642011|NCT01740128|Secondary|Change From Baseline in Berg Balance Scale Sitting With Back Unsupported Score.|Change between baseline and Evaluation #2 in Berg sitting unsupported subscore. Range 0-4, higher better.|Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Incomplete analysis due to dropouts before post-testing|||units on a scale||Standard Deviation|Mean
2642012|NCT01740128|Secondary|Change From Baseline in ISNCSCI Lower Extremity Motor Score.|Change between baseline and Evaluation #2 in lower extremity motor score derived from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). Range of scores 0-50, higher is better.|Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|One subject in multimodal group failed to appear for post-intervention testing for this outcome.|||units on a scale||Standard Deviation|Mean
2642013|NCT01740128|Primary|Change in Motor Evoked Potential (MEP) Amplitude in the Tibialis Anterior Muscle at the End of Training.|Change between baseline and Evaluation #2 in motor evoked potential area in the tibialis anterior muscle.|Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)|Only two participants in the study had consistent MEPs at baseline.|||Amplitude percentage of Mmax|||Number
2642014|NCT01740089|Other Pre-specified|Immunogenicity|Number of randomized patients with neutralizing antibodies to IFN alfa on weeks 0, 12, 24, 48 (for patients with genotype 1 or 4) and 24 weeks after last dose of study treatment.|Weeks 0, 12, 24, 48 (for patients with genotype 1 or 4) and 24 weeks after last dose of study treatment||||participants|||Number
2642015|NCT01740089|Secondary|Number of Patients Who Have Undetectable HCV RNA (< 15 IU/ml) at the End of Treatment.||After 24 weeks of treatment for patients with genotype 2 or 3 and after 48 weeks of treatment for patients with genotype 1 or 4.||||participants|||Number
2642016|NCT01740089|Secondary|Number of Randomized Patients Achieving Sustained Virologic Response (SVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) 24 Weeks After Last Dose of Study Treatment.||24 weeks after last dose of study treatment||||participants|||Number
2642017|NCT01740089|Secondary|Number of Randomized Patients Achieving Rapid Virologic Response (RVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) After 4 Weeks of Treatment.||4 weeks||||participants|||Number
2642018|NCT01740089|Primary|Number of Randomized Patients Achieving Early Virologic Response (EVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) or ≥ 2log10 Decrease of Viral Load After 12 Weeks of Study Treatment.||12 weeks||||participants|||Number
2642019|NCT01739803|Secondary|Days in Hospital|"We used a standardized patient reporting approach to collect direct healthcare utilizations data, including days in hospital. A brief healthcare screening questionnaire was administered to both the intervention and control groups on a monthly basis during the one-year study period. Monthly recall periods were chosen to minimize bias and forgetfulness. The questionnaire collected the number of times each month a participant utilized a direct medical service, specifically, days in hospital, emergency department (ED) visit, outpatient visit (clinic, physician office), and home healthcare visit.~Analysis compared proportion of each group who had at least one day in hospital during the 12-month study period."|12 months||||percentage of participants|||Number
2642020|NCT01739803|Secondary|Health-related Quality of Life (HQoL)|"The EQ-5D is a multi-attribute, preference-based HQoL instrument. Considered a global HQoL measure, the EQ-5D is a descriptive system that classifies respondents into one of 243 distinct health states based on five dimensions (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has three levels, reflecting no problems, some problems, and extreme problems. A scoring function assigns a value (EQ-5DIndex score) to self-reported health states from a set of preference weights that have been empirically derived. The EQ-5D's total scale (preference value) range is from 0 to 1.0. On this scale, the preference value of 1.0 represents perfect health and 0.0 represents death. Preference values less than 0 are possible, but not reflected on the scale, and reflect health states that the U.S. population consider worse than death."|12 months||||units on a scale||Standard Deviation|Mean
2642021|NCT01739803|Primary|Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period|"Immunosuppressant therapy adherence as measured by pharmacy refill records. Adherence was calculated quarterly for one year by using the number of days between prescription (IST) refills. If the total number of days between refills was less than or equal to the total days' supply of IST, the participant's adherence rate was 1.0, or 100%. If the number of days between refills was greater than the days' supply, the adherence rate was calculated as follows:~1 - [(Days Between Refills - Total Days Supply)/Days Between Refills] = Adherence Rate for Quarterly Time Period~At the end of the 12-month study period, the quarterly adherence rates were averaged to produce an overall adherence rate for the study period."|12 months|Intention to treat, as per protocol|||medication possession ratio (proportion)||Standard Deviation|Mean
2642022|NCT01739790|Primary|Changes in the Saint George's Respiratory Questionnaire|The St. George's Respiratory Questionnaire (SGRQ) is scored on a scale of 1 to 100 with 100 representing the worst respiratory health status. The instrument is self-administered at baseline and again after 8-weeks of treatment.|Baseline to 8 weeks||||units on a scale||Standard Deviation|Mean
2642023|NCT01739595|Primary|Change in Sperm Concentration|"Proportion of subjects with a 50% or greater decrease in sperm concentration from baseline after 12 weeks of treatment in Androxal treated subjects to placebo.~The difference between the proportions (placebo minus Androxal) and corresponding 95% confidence interval was determined and compared to the equivalence limit of -20%. If the lower limit of the 95% confidence interval was greater than -20%, then Androxal would be concluded to be non-inferior to placebo in causing a 50% reduction in sperm concentrations."|3 months|ITT|||percentage of subjects|||Number
2642024|NCT01739595|Primary|Subjects With Testosterone in Normal Range After Treatment|"Proportion (percent) of subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment. Cavg was calculated as the numerical average of 24-hour serial testosterone assessments at 0, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours after dosing.~If the lower limit of the 95% confidence interval for the Androxal treatment group at Week 12 is at least 67%, then the coprimary endpoint based on the Cavg for testosterone would have been achieved.~FDA specified primary endpoint did not include comparison to placebo, thus the proportion of placebo subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment was not calculated."|3 months|ITT population.|||Percentage of Subjects||95% Confidence Interval|Number
2642025|NCT01739400|Primary|Change in Peripheral Oxygen Saturation (SpO2) at Rest at Month 6 and 12|No imputation of missing data for SpO2 was applied. Oxygen saturation assessed by pulse oximetry: peripheral oxygen saturation (SpO2) at rest before the 6-minute walk test (6MWT)|From baseline in DB parent study (AC-055-305, NCT01743001) up to month 12 in this OL study.|No imputation of missing data for oxygen saturation as assessed by SpO2 was applied. Therefore out of 109 subjects 104 subjects were analyzed at month 6 and 92 subjects at month 12 in the DB-macitentan group. In the DB-placebo group out of 108 subjects 103 subjects were analyzed at month 6 and 84 subjects at month 12.|||% of oxygen saturation at rest||Standard Deviation|Mean
2642026|NCT01739400|Primary|Change in Borg Dyspnea Score at Month 6 and 12|The Borg dyspnea score rates the severity of dyspnea (difficult or labored breathing) on a scale from 0 ('Nothing at all') to 10 ('Very, very severe - maximal'). For missing Borg dyspnea index values in the OL study, the following imputation rules were applied: If the reason for missing data was death, a value of 10 was imputed for all Borg visits from the date of death. For any other reasons, the last available value was carried forward.|From baseline in DB parent study (AC-055-305, NCT01743001) up to month 12 in this OL study.||||score on a scale||Standard Deviation|Mean
2642027|NCT01739400|Primary|Change in WHO Functional Class (FC) at Month 6 and 12|Class I: no symptoms with exercise or at rest. No limitation of activity. Class II: No symptoms at rest but slight limitation with ordinary activities causing symptoms (e.g. short of breath with climbing stairs). Class III: may not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting. Class IV: symptoms at rest and inability to carry out any physical activity without symptoms. Patients in class IV manifest signs of right heart failure. For missing WHO FC values in the OL study, the following imputation rules were applied: If the reason for missing data was death, class IV was imputed for all WHO visits from the date of death. For any other reasons, the last available value was carried forward.|From baseline in DB parent study (AC-055-305, NCT01743001) up to month 12 in this OL study.||||Participants|||Count of Participants
2642028|NCT01739400|Primary|Change in Exercise Capacity as Measured by 6-minute Walking Distance (6MWD) Month 6 and 12|NOTE: The MAESTRO-OL study was exploratory in nature and no primary efficacy and safety endpoint were defined in the clinical protocol. This and the other exploratory efficacy outcome measures posted were selected to be reported as a primary endpoints. All efficacy analyses were considered exploratory. The analyses of the exploratory efficacy endpoints focused on the absolute values and on the change from DB baseline to Week 16 in the DB study and to Month 6 and Month 12 in the OL study. For missing 6MWD values in the OL study, the following imputation rules were applied: If the reason for missing data was death, a distance of zero (0) meters was imputed for all 6MWD visits from the date of death. For any other reasons, the last available value was carried forward.|From baseline in DB parent study (AC-055-305, NCT01743001) up to month 12 in this OL study.||||meter (m)||Standard Deviation|Mean
2642029|NCT01739361|Secondary|Serum Creatinine After 72 Hours of Treatment With Acetaminophen or Placebo|serum creatinine measurements at 72 hours|72 hours||||mg/dL||Inter-Quartile Range|Median
2642030|NCT01739361|Secondary|In-hospital Mortality|percent of patients who died in the hospital|Patients will be followed through the end of their hospital stay, an average of 5 weeks||||Participants|||Count of Participants
2642031|NCT01739361|Primary|F2-isoprostanes After 72 Hours of Acetaminophen or Placebo|F2-isoprostanes are a marker of oxidative stress, specifically lipid peroxidation.|72 hours after randomization||||pg/mL||Inter-Quartile Range|Median
2642032|NCT01739348|Secondary|[Part I (Base Study)] Change From Baseline in Mini-Mental State Examination (MMSE) Score|Least squares mean change from baseline at week 78 was assessed for MMSE score. The MMSE is a cognitive assessment of 5 domains including: orientation; attention; memory; language; and constructional praxis. These domains are assessed over the course of 11 total questions related to the participant. Participants are scored based on the number of correct responses; depending on the question, potential scores range from 0 (no correct response) to either 1 (4 questions), 2 (1 question), 3 (3 questions), or 5 (3 questions). Scores from each question are summed to the total MMSE score, with total scores ranging from 0-30. Higher scores indicate better cognitive performance. Further, deterioration in cognitive performance would be reflected by decreases in MMSE score.|Baseline and week 78|All randomized participants with a baseline and ≥1 within-analysis-window MMSE observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2642083|NCT01739231|Secondary|Part B: Mean Total Weight of Grade 3-5 Stools Passed Per Volunteer|"Grades were defined as follows:~Grade 1: firm, formed (normal) Grade 2: soft, formed (normal) Grade 3: viscous opaque liquid or semi-liquid which assumes the shape of the container Grade 4: watery, non-viscous, opaque liquid which assumes the shape of the container Grade 5: clear or translucent, watery or mucoid liquid which assumes the shape of the container"|5 days||||grams||Standard Deviation|Mean
2642143|NCT01738750|Secondary|Hospital/Operative Dollars|A comparison of the overall hospital admission and operative dollars for acute appendicitis and appendectomy between the two groups|Data will be collected within an expected average of 3 months post-discharge with data presented within 1 year||||Dollar||Inter-Quartile Range|Median
2642033|NCT01739348|Secondary|[Part I (Base Study)] Change From Baseline in Neuropsychiatric Inventory (NPI) Score|Least squares mean change from baseline at week 78 was assessed for NPI score. NPI is a clinical assessment of psychiatric status, covering 12 domains: delusion; hallucination; agitation/aggression; depression/dysphoria; anxiety; elation/euphoria; apathy/indifference; disinhibition; irritability/lability; aberrant motor behavior; sleep/nighttime behaviors; and appetite/eating disorders. Based on an interview of the participant's caregiver, each domain is assessed for symptom frequency [range: 1 (occasional) to 4 (very frequent)] and severity [range: 1 (mild) to 3 (severe)]. Domain scores [range: 0 to 12] are calculated as the product of the frequency and severity scores (i.e. frequency x severity); if no symptoms are present, domain score is 0. The 12 domain scores sum to a total NPI score [range: 0 (no symptoms in any domain) to 144]. Higher scores reflect more severe psychiatric impairment, with increases in impairment reflected by increases in NPI score.|Baseline and week 78|All randomized participants with a baseline and ≥1 within-analysis-window NPI observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2642034|NCT01739348|Secondary|[Part I (Base Study)] Percentage of Participants Achieving Responder Status|The percentage of participants achieving responder status at week 78 was assessed. To determine which participants were considered responders, a linear regression was conducted at the participant level, yielding an estimated 78-week rate of change (i.e., a slope) for each participant with respect to ADAS-Cog and ADCS-ADL. To be declared a responder, a participant must have: 1) ADAS-Cog and ADCS-ADL observations at baseline and 78 weeks of treatment; 2) an ADAS-Cog slope > 4.0 over 78 weeks, and 3) an ADCS-ADL slope > -6.3 over 78 weeks. A participant failing to meet any of these criteria was designated as a non-responder at Week 78.|Week 78|All randomized participants in Part I receiving ≥1 dose of trial treatment. Per protocol, the first 200 participants enrolled prior to IA (across all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded from analysis.|||Percentage of Participants|||Number
2642035|NCT01739348|Secondary|[Part I (Base Study)] Change From Baseline in Cortical Amyloid Load Assessed by [18F]Flutemetamol PET Standard Uptake Value Ratio (SUVR)|Least squares mean change from baseline at week 78 was calculated for SUVR, a measure of brain cortical amyloid load. Per protocol, SUVR was analyzed as part of a substudy in Part I, with testing occurring only at select trial sites. Participants receive the PET tracer [18F]Flutemetamol (IV). After 90 minutes, participants receive 4 PET scans (5 minutes each in duration). Using these PET scan images, specific brain ROIs (frontal, temporal, and parietal lobes; anterior and posterior cingulate and precuneus) are used to calculate regional SUVRs, defined as the relative ratio of pixel intensities at a specific ROI compared to a reference region (RR; subcortical white matter). These regional SUVRs are then averaged to compute a composite cortical SUVR for each participant. Higher composite cortical SUVR values indicate increased amyloid load, with negative changes in composite cortical SUVR over time indicating decreases in brain amyloid load.|Baseline and week 78|All randomized participants with a baseline and ≥1 within-analysis-window SUVR observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat did not receive SUVR testing and were excluded.|||SUVR||95% Confidence Interval|Least Squares Mean
2642036|NCT01739348|Secondary|[Part I (Base Study)] Fold Change From Baseline in Cerebrospinal Fluid (CSF) Total Tau|Least squares mean fold change from baseline at week 78 was calculated for Total Tau concentration in CSF, a measure of brain tau pathology. Per protocol, CSF Total Tau concentration was analyzed as part of a substudy in Part I, with testing occurring only at select trial sites. Least squares mean fold change from baseline >1 indicates increased Total Tau concentration in the CSF.|Baseline and week 78|All randomized participants with a baseline and ≥1 within-analysis-window CSF Total Tau observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.|||Fold Change||95% Confidence Interval|Least Squares Mean
2642037|NCT01739348|Secondary|[Part I (Base Study)] Percent Change From Baseline in Total Hippocampal Volume (THV)|Least squares mean percent change from baseline at week 78 was calculated for Total Hippocampal Volume (THV) as measured by volumetric magnetic resonance imaging (vMRI). Longitudinal analysis of within-participant THV is computed using a change analysis algorithm using tensor-based morphometry. This technique produces one measure of volume change calculated from the registration of serial vMRI scans at the follow-up time point relative to baseline. Negative percent changes from baseline indicate decreases in THV (i.e. increased hippocampal atrophy).|Baseline and week 78|All randomized participants with a baseline and ≥1 within-analysis-window THV observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled prior to IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.|||Percent Change||95% Confidence Interval|Least Squares Mean
2642038|NCT01739348|Secondary|[Part I (Base Study)] Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score|Least squares mean change from baseline at week 78 was assessed for CDR-SB score. The CDR-SB score is a clinical rating of global cognitive function, comprised of 6 domains including: memory; orientation; judgment and problem solving; community affairs; home and hobbies; and personal care. For each domain, the degree of impairment is assessed by a semi-structured interview of the participant as well as the participant's caregiver. For each domain, potential scores range from 0 (no impairment) to 3 (severe impairment). Scores from each individual domain are summed to the total CDR-SB score, with total scores ranging from 0-18. Higher scores indicate more severe cognitive impairment. Further, increases in cognitive impairment would be reflected by increases in CDR-SB score.|Baseline and week 78|All randomized participants with a baseline and ≥1 within-analysis-window CDR-SB observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2642102|NCT01739231|Primary|Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)||Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3|Subjects who received the vaccination and had valid test results.|||fold change||95% Confidence Interval|Geometric Mean
2643394|NCT01729156|Secondary|Fatty Acid Turnover|Fatty acid turnover assessed as whole body C11-palmitate turnover|90 days||||micromol/min||Standard Deviation|Mean
2642039|NCT01739348|Primary|[Part II (Extension Study)] Number of Participants Who Discontinued From Study Drug Due to an Adverse Event|The number of participants discontinuing from study drug due to an AE in Part II was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product is also an AE.|From week 78 (end of treatment in Part I) up to week 260 of Part II|Includes all randomized participants continuing to Part II, receiving ≥1 dose of trial treatment in Part II. For included participants, the data reflect treatment discontinuations occurring in Part II only.|||Participants|||Count of Participants
2642040|NCT01739348|Primary|[Part I (Base Study)] Number of Participants Who Discontinued From Study Drug Due to an Adverse Event|The number of participants discontinuing from study drug due to an AE in Part I was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product is also an AE.|Up to week 78|Includes all randomized participants in Part I receiving ≥1 dose of trial treatment.|||Participants|||Count of Participants
2642041|NCT01739348|Primary|[Part II (Extension Study)] Number of Participants Who Experienced an Adverse Event|The number of participants experiencing an adverse event (AE) in Part II was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product is also an AE.|From week 78 (end of treatment in Part I) up to week 262 of Part II|Includes all randomized participants continuing to Part II, receiving ≥1 dose of trial treatment in Part II. For included participants, the data reflect AEs occurring in Part II only.|||Participants|||Count of Participants
2642042|NCT01739348|Primary|[Part I (Base Study)] Number of Participants Who Experienced an Adverse Event|The number of participants experiencing an adverse event (AE) in Part I was assessed. An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product is also an AE.|Up to week 80 (up to 2 weeks following cessation of study treatment in Part I)|Includes all randomized participants in Part I receiving ≥1 dose of trial treatment.|||Participants|||Count of Participants
2642043|NCT01739348|Primary|[Part II (Extension Study)] Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score|Mean change from baseline at week 104 was assessed for the ADCS-ADL score. The ADCS-ADL score measures the performance of activities of daily living, calculated from a 24-question survey. For each of the 24 questions, scores range from 0 (no independence) to (depending on the question) either 2 (1 question), 3 (17 questions), 4 (5 questions), or 5 (1 question), with higher scores indicating greater independence in activity performance. Scores from individual questions are summed into a total ADCS-ADL score, with total scores ranging from 0 to 78. Lower scores indicate less independence in activity performance and, as a result, greater AD severity. Further, increases in AD severity over time would be reflected by decreases in ADCS-ADL score. Per study protocol, the baseline measurement to be used was the baseline measurement obtained in Part I.|Baseline and week 104|All randomized participants continuing to Part II, with a baseline and ≥1 within-analysis-window ADCS-ADL observation subsequent to ≥1 dose of study drug (FAS population), having an ADCS-ADL observation at week 104. Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat were excluded.|||Score on a Scale||Standard Deviation|Mean
2642044|NCT01739348|Primary|[Part II (Extension Study)] Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score|Mean change from baseline at week 104 was assessed for the ADAS-Cog score. ADAS-Cog measures cognition by assessing 11 metrics impaired in Alzheimer's Disease (AD): speech; speech comprehension; word finding; word recall; object/finger naming; orientation; obeying commands; ideational praxis; constructional praxis; word recognition; and remembering instruction. For each metric, scores range from 0 (no impairment) to (depending on the metric) either 5 (8 metrics), 8, 10, or 12 (1 metric each); higher scores indicate more severe impairment. Individual scores sum to a total ADAS-Cog score, ranging from 0-70. Higher total scores indicate greater cognitive impairment and AD severity. Further, increases in AD severity over time would be reflected by increases in ADAS-Cog score. Per study protocol, the baseline measurement to be used was the baseline measurement obtained in Part I.|Baseline and week 104|All randomized participants continuing to Part II, with a baseline and ≥1 within-analysis-window ADAS-Cog observation subsequent to ≥1 dose of study drug (FAS population), having an ADAS-Cog observation at week 104. Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat were excluded.|||Score on a Scale||Standard Deviation|Mean
2642071|NCT01739309|Secondary|Progression-Free Survival (PFS)|PFS is defined as the date of first dose until disease progression or death due to any cause based on the Response Criteria for Non-Hodgkin's Lymphomas. Disease progression is defined as the first date of documentation of a new lesion or enlargement of a previous lesion, or the date after radiologic assessment has been completed. PD is defined as an increase by 25% in longest diameter, new lesion, or assessable disease progression. Progression-free survival was analyzed using Kaplan-Meier methods. If the participant receives other anticancer therapy prior to progression, the participant was censored at the start date of this other therapy.|From Date of First Dose until Disease Progression or Death Due to Any Cause (Up to 28 Months)|All participants who received at least one dose of study drug. 9 participants were censored.|||Months||95% Confidence Interval|Median
2642045|NCT01739348|Primary|[Part I (Base Study)] Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score|Least squares mean change from baseline at week 78 was assessed for the ADCS-ADL score. The ADCS-ADL score measures the performance of activities of daily living, calculated from a 24-question survey. For each of the 24 questions, scores range from 0 (no independence) to (depending on the question) either 2 (1 question), 3 (17 questions), 4 (5 questions), or 5 (1 question), with higher scores indicating greater independence in activity performance. Scores from individual questions are summed into a total ADCS-ADL score, with total scores ranging from 0 to 78. Lower scores indicate less independence in activity performance and, as a result, greater AD severity. Further, increases in AD severity over time would be reflected by decreases in ADCS-ADL score.|Baseline and week 78|All randomized participants with a baseline and ≥1 within-analysis-window ADCS-ADL observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2642046|NCT01739348|Primary|[Part I (Base Study)] Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score|Least squares mean change from baseline at week 78 was assessed for the ADAS-Cog score. ADAS-Cog measures cognition by assessing 11 metrics impaired in Alzheimer's Disease (AD): speech; speech comprehension; word finding; word recall; object/finger naming; orientation; obeying commands; ideational praxis; constructional praxis; word recognition; and remembering instruction. For each metric, scores range from 0 (no impairment) to (depending on the metric) either 5 (8 metrics), 8, 10, or 12 (1 metric each); higher scores indicate more severe impairment. Individual scores sum to a total ADAS-Cog score, ranging from 0-70. Higher total scores indicate greater cognitive impairment and AD severity. Further, increases in AD severity over time would be reflected by increases in ADAS-Cog score.|Baseline and week 78|All randomized participants with a baseline and ≥1 within-analysis-window ADAS-Cog observation subsequent to ≥1 dose of study drug (FAS population). Per protocol, the 200 participants enrolled before IA (all arms) and all participants receiving 60mg Verubecestat (Arm C) were excluded.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2642047|NCT01739335|Other Pre-specified|Change in Adrenocorticotropic Hormone (ACTH) From Baseline to 4-week|Mifepristone will induce acute increase in Cortisol and ACTH levels. Higher ACTH value indicates higher magnitude of mifepristone's effects on negative feedback inhibition. ACTH value in placebo group at follow-up visits will remain at the similar level as its baseline magnitude. A positive change value indicates an increased ACTH level at 4-week (i.e., higher magnitude on negative feedback inhibition) compared to its baseline value, while a negative change value indicates an opposite direction.|Baseline to 4-week|Participants who were included in the modified intent-to-treat (mITT) population and also did not miss 4-week blood collection on ACTH were analyzed. The mITT population include participants who took at least a single dose of study medication and also met all study eligibility criteria.|||pg/ml||Inter-Quartile Range|Median
2642048|NCT01739335|Other Pre-specified|Change in Adrenocorticotropic Hormone (ACTH) From Baseline to 1-week|Mifepristone will induce acute increase in Cortisol and ACTH levels. Higher ACTH value indicates higher magnitude of mifepristone's effects on negative feedback inhibition. ACTH value in placebo group at follow-up visits will remain at the similar level as its baseline magnitude. A positive change value indicates an increased ACTH level at 1-week (i.e., higher magnitude on negative feedback inhibition) compared to its baseline value, while a negative change value indicates an opposite direction.|baseline to 1-week|Participants who were included in the modified intent-to-treat (mITT) population and also did not miss 1-week blood collection on ACTH were analyzed. The mITT population include participants who took at least a single dose of study medication and also met all study eligibility criteria.|||pg/ml||Inter-Quartile Range|Median
2642049|NCT01739335|Other Pre-specified|Change in Plasma Cortisol From Baseline to 4-Week|Mifepristone will induce acute increase in Cortisol and ACTH levels. Higher Cortisol value indicates higher magnitude of mifepristone's effects on negative feedback inhibition. Cortisol value in placebo group at follow-up visits will remain at the similar level as its baseline magnitude. A positive change value indicates an increased cortisol level at 4-week (i.e., higher magnitude on negative feedback inhibition) compared to its baseline value, while a negative change value indicates an opposite direction.|Baseline to 4-week|Participants who were included in the modified intent-to-treat (mITT) population and also did not miss 4-week blood collection on cortisol were analyzed. The mITT population include participants who took at least a single dose of study medication and also met all study eligibility criteria.|||ug/dl||Inter-Quartile Range|Median
2642050|NCT01739335|Other Pre-specified|Change in Plasma Cortisol From Baseline to 1-Week|Mifepristone will induce acute increase in Cortisol and ACTH levels. Higher Cortisol value indicates higher magnitude of mifepristone's effects on negative feedback inhibition. Cortisol value in placebo group at follow-up visits will remain at the similar level as its baseline magnitude. A positive change value indicates increased cortisol level at 1-week (i.e., higher magnitude on negative feedback inhibition) compared to its baseline value, while a negative change value indicates an opposite direction.|Baseline to 1-week|Participants who were included in the modified intent-to-treat (mITT) population and also did not miss 1-week blood collection on cortisol were analyzed. The mITT population include participants who took at least a single dose of study medication and also met all study eligibility criteria.|||ug/dl||Inter-Quartile Range|Median
2642051|NCT01739335|Other Pre-specified|Change in Anger Level (Measured by the STAXI Total Score) From Baseline to 4-Week and 12-Week|The State-Trait Anger Expression Inventory (STAXI) total score is the sum of 10 items assessing intensity of anger as an emotional state (State Anger) and the disposition to experience angry feelings as a personality trait (Trait Anger). Each item consists of a 4-point scale (1=not at all, 4=very much) that assess intensity of anger at a particular moment and the frequency of anger experience, expression and control. The STAXI total score ranges from 10 to 40, with a higher score indicating a higher intensity of anger.The sum of the 7 component scores yields the PSQI total score (range 0-21) with a higher score indicating a worse sleep quality. A positive change score indicates an increased STAXI total score (i.e., higher intensity of anger) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.|Baseline to 4-week and 12-week|Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2642052|NCT01739335|Other Pre-specified|Change in Sleep Quality (Measured by the PSQI Total Score) From Baseline to 4-Week and 12-Week|The Pittsburgh Sleep Quality Index (PSQI) assesses self-report sleep quality and disturbances. Nineteen individual items generate 7 component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction. Each component is scored from 0=better to 3=worse. The sum of the 7 component scores yields the PSQI total score (range 0-21) with a higher score indicating a worse sleep quality. A positive change score indicates an increased PSQI total score (i.e., worse sleep quality) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.|baseline to 4-Week and 12-Week|Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2642053|NCT01739335|Other Pre-specified|Changes in PTSD Symptom Severity (Measured by the Stressful Life Total Score From the PTSD Checklist) From Baseline to 4-Week and 12-Week|"Stressful life total score (ranges 17-85) is the sum of the severity ratings of the 17 PTSD-related symptoms (each symptom is rated on a 5-point scale of 1=not at all to 5=extremely) over the past week. It evaluates the extent to which responders have been bothered by the symptoms of PTSD. The higher stressful life score indicates more stressful life events. A positive change score indicates an increased stressful life total score (i.e., more stressful life events) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction."|baseline to 4-Week and 12-Week|Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2642054|NCT01739335|Other Pre-specified|Change in Depression (Measured by the BDI Total Score) From Baseline to 4-Week and 12-Week|The Beck Depression Inventory (BDI) total score (ranges 0-63) is the sum of 21 items (each item rated on a 4-point scale of 0 to 3) relating to symptoms of depression, cognitions, and physical symptoms. The BDI total score measures the overall severity of depression. The higher the BDI total score, the more severe the depression. A positive change score indicates an increased BDI total score (i.e., more severe depression) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.|baseline to 4-Week and 12-Week|Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2642055|NCT01739335|Other Pre-specified|Change in CAPS Hyperarousal Symptom Scores From Baseline to 4-Week and 12-Week|The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. Its hyperarousal symptom subscale (ranges 0 - 40) is the sum of 5 PTSD symptoms (each ranges 0 - 8) in the hyperarousal symptom subcategory. A higher hyperarousal symptom score indicates worse PTSD symptoms. A positive change score indicates an increased hyperarousal symptom score (i.e., worse PTSD symptoms) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.|baseline to 4-Week and 12-Week|Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2642056|NCT01739335|Other Pre-specified|Change in CAPS Avoidance Symptom Scores From Baseline to 4-Week and 12-Week|"The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. Its avoidance symptom subscale (ranges 0 - 56) is the sum of 7 PTSD symptoms (each ranges 0 - 8) in the avoidance/emotional numbing symptom subcategory. A higher avoidance symptom score indicates worse PTSD symptoms. A positive change score indicates an increased avoidance symptom score (i.e., worse PTSD symptoms) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.~The higher is the avoidance/emotional numbing PTSD subscale score, the worse is the PTSD symptom."|baseline to 4-Week and 12-Week|Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2642057|NCT01739335|Other Pre-specified|Change in CAPS Intrusive Symptom Scores From Baseline to 4-Week and 12-Week|The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. Its intrusive symptom subscale (ranges 0 - 40) is the sum of 5 PTSD symptoms (each ranges 0 - 8) in the intrusive/re-experiencing symptom subcategory. A higher intrusive symptom score indicates worse PTSD symptoms. A positive change score indicates an increased intrusive symptom score (i.e., worse PTSD symptoms) at 4-week (or 12-week) compared to its baseline value, while a negative change score indicates an opposite direction.|baseline to 4-Week and 12-Week|Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% CI reported is the least square estimates from the repeated-measures analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2642058|NCT01739335|Secondary|Change in CAPS Total Score From Baseline to 4-week and 12-week|The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. The CAPS total score ranges 0 to 136, which is the sum of 17 PTSD symptoms (each symptom is the sum of the frequency score (ranges 0-4) and the intensity score (ranges 0-4)) in the three different symptom subcategories (intrusive/re-experiencing (0-40), avoidance/numbing (0-56) and hyperarousal (0-40)). A higher CAPS total score indicates worse PTSD symptoms. A positive change score indicates an increased CAPS total score (i.e., worse PTSD symptoms) at 4-week (12-week) compared to its baseline value, while a negative change score indicates an opposite direction.|baseline to 4-week|Participants in the modified intent-to-treat (mITT) population were analyzed. This includes 80 randomized participants who took at least a single dose of study medication and met all study eligibility criteria. Mean and 95% Confidence Interval (CI) reported is the least square estimates from the repeated-measures analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2642059|NCT01739335|Secondary|Percentage of Clinical Responders at 12-week Follow-up (End of Study)|A clinical responder at 12-week is defined as a participant who achieves a 30% or greater reduction in CAPS total score (past week symptom status) from baseline to 12-week follow-up. The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. The CAPS total score (ranges 0 - 136) is the sum of 17 PTSD symptoms (each symptom is the sum of the frequency score (ranges 0-4) and the intensity score (ranges 0-4)) in the three different symptom subcategories (intrusive/re-experiencing (0-40), avoidance/numbing (0-56) and hyperarousal (0-40)). The higher is the CAPS total score, the worse is the PTSD symptom. Higher percentage of responders indicate a better drug effect in treating PTSD symptoms.|week 12|Participants who were included in the modified intent-to-treat (mITT) population and also did not miss 12-week CAPS assessment were analyzed. The mITT population include participants who took at least a single dose of study medication and also met all study eligibility criteria.|||Participants|||Count of Participants
2642060|NCT01739335|Primary|Percentage of Clinical Responders at 4-week Follow-up|A clinical responder at 4-week is defined as a participant who achieves a 30% or greater reduction in CAPS total score (past week symptom status) from baseline to 4-week follow-up. The Clinical Administered PTSD Scale (CAPS) was used to assess the diagnosis of PTSD symptoms. The CAPS total score (ranges 0 - 136) is the sum of 17 PTSD symptoms (each symptom is the sum of the frequency score (ranges 0-4) and the intensity score (ranges 0-4)) in the three different symptom subcategories (intrusive/re-experiencing (0-40), avoidance/numbing (0-56) and hyperarousal (0-40)). The higher is the CAPS total score, the worse is the PTSD symptom. Higher percentage of responders indicate a better drug effect in treating PTSD symptoms.|week 4|Participants who were included in the modified intent-to-treat (mITT) population and also did not miss 4-week CAPS assessment were analyzed. The mITT population include participants who took at least a single dose of study medication and also met all study eligibility criteria.|||Participants|||Count of Participants
2642061|NCT01739309|Secondary|PK: Clearance (CL) of Abemaciclib||Predose, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose|Zero participants were analyzed. CL was not calculated due to PK sampling schedule was not suitable for estimation of these PK parameters.||||||
2642062|NCT01739309|Secondary|PK: Volume of Distribution (Vd) of Abemaciclib||Predose, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose|Zero participants were analyzed. Vd was not calculated by non-compartmental analysis with the available data.||||||
2642063|NCT01739309|Secondary|PK - Terminal Half Life (T 1/2) of Abemaciclib||Predose, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose|Zero participants were analyzed due to the calculation of half-life (t1/2) by noncompartmental analysis was not possible due to cessation of sampling at 8 hours postdose.||||||
2642064|NCT01739309|Secondary|PK - Area Under the Concentration-Time Curve From Zero to Last Time Point (AUC[0-tlast]) of Abemaciclib||Predose, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose|All randomized who received at least one dose of study drug and had evaluable PK data.|||hour*nanogram/milliter (hr*ng/ml)||Geometric Coefficient of Variation|Geometric Mean
2642065|NCT01739309|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Abemaciclib||Predose, 1 hour (hr), 2 hr, 4 hr, 6 hr, 8 hr, 10 Hours Postdose|All participants who received at least one dose of study drug and had evaluable PK data.|||nanogram/milliliter (ng/ml)||Geometric Coefficient of Variation|Geometric Mean
2642066|NCT01739309|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) TOI and Subscale Scores|Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population). The FACT-Lym TOI Score for the follicular lymphoma population was derived from the following 3 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym TOI Score is the sum of the 3 individual subscales (range 0-116). Higher scores indicate better outcomes and lower scores indicate worse outcomes. A positive change from baseline indicates an improvement and a negative change is a detriment.|Baseline, Cycle 5 (Up To Day 140)|All participants who received at least one dose of study drug and had baseline and post baseline FACT-Lym data.|||units on a scale||Standard Deviation|Mean
2642067|NCT01739309|Secondary|Disease-Free Survival|Disease-free survival is measured from first dose until date of disease progression or the time of occurrence of disease-free state or attainment of a CR to disease recurrence or death as a result of lymphoma or acute toxicity of treatment. Progressive Disease (PD) is defined as an increase by 25%, new lesion, or accessible progressive disease. Disease-Free Survival was assessed based on the response criteria of Non-Hodgkins Lymphomas. Disease-free survival is only defined for participants with response.|First Dose Until Date of Disease Progression or Time of Occurrence Disease-Free State or CR to Disease Recurrence or Death (Up to 28 Months)|All participants who received at least one dose of study drug. 5 participants were censored.|||Months||95% Confidence Interval|Median
2642068|NCT01739309|Secondary|Time to Disease Progression|Time to Disease Progression is based on the response criteria of Non-Hodgkin's Lymphomas. Time to progression (TTP) is defined as the time from date of first dose until documented disease progression or death as a result of lymphoma. In TTP, deaths from other causes are censored either at the time of death or at an earlier time of assessment.|From Date of First Dose Until Disease Progression (Up to 28 Months)|All participants who received at least one dose of study drug. 17 participants were censored.|||Months||95% Confidence Interval|Median
2642069|NCT01739309|Secondary|Event-Free Survival|Event-free survival (time to treatment failure) is measured from date of first dose to disease progression, or discontinuation of treatment for any reason (eg, disease progression, toxicity, participant preference, initiation of new treatment without documented progression, or death due to any cause). 2 participants were censored. Event-free survival is defined only for responders (participants with a CR, CRu, or PR).|From Date of First Dose until Disease Progression, Discontinuation of Treatment, or Death Due to Any Cause (Up to 28 Months)|All participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2642070|NCT01739309|Secondary|Overall Survival (OS)|OS is defined as from the date of first dose until death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS were censored on the last date the participant is known to be alive. Overall survival was analyzed using Kaplan-Meier methods.|From Date of First Dose until Death Due to Any Cause (Up to 28 Months)|All participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2643395|NCT01729156|Primary|Whole Body Glucose Rd|Whole body basal glucose metabolism assessed by [3-3H]glucose tracer kinetics|90 days||||mg/kg/min||Standard Deviation|Mean
2642072|NCT01739309|Secondary|Duration of Objective Response (DOR)|"DOR is from the date when criteria for objective response (ie, CR, CRu or PR) are met, to the first documentation of relapse or disease progression or death due to any cause. DOR is based on the Response Criteria for Non-Hodgkin's Lymphomas of the Cancer and Leukemia Group B. CR is defined as disappearance of all disease, no symptoms and must last 4 weeks or unconfirmed CR, (CRu). PR is defined as >= 50% decrease in sum of product diameter (SPD), no increase or new lesion, or assessable disease stable or decreased, must last 4 weeks or CRu. Progressive Disease or PD is defined as an increase by 25% in longest diameter, new lesion, or assessable disease progression. DOR was analyzed using Kaplan-Meier methods. If the participant receives other anticancer therapy prior to progression, the participant was censored at the start date of this other therapy."|From Date of CR, CRu or PR until Disease Progression or Death Due to Any Cause (Up to 28 Months)|All participants who received at least one dose of study drug. 4 participants were censored.|||months||95% Confidence Interval|Median
2642073|NCT01739309|Secondary|Percentage of Participants Who Achieve Best Overall Disease Response (BOR) That Includes CR, CRu or PR|BOR was assessed based on the Response Criteria for Non-Hodgkin's Lymphomas and was measured from date of first dose until the earliest evidence of objective progression or start of new anticancer therapy. Any responses observed after objective progression or after the start of new anticancer therapy are excluded from the determination of best response. A second confirmatory radiological tumor assessment was performed at least 28 days after the first evidence of response (CR, CRu, or PR). Two objective status determinations of CR (or CRu) before progression were required for a best response of CR (or CRu). Two determinations of PR or better before progression, but not qualifying for CR or CRu, were required for a best response of PR.|From Date of First Dose until Disease Progression (Up to 28 Months)|All participants who received at least one dose of study drug and had evaluable BOR data.|||percentage of participants||95% Confidence Interval|Number
2642074|NCT01739309|Primary|Percentage of Participants Who Achieve Disease Control Rate (DCR) Which Includes Complete Response (CR), Complete Response Unconfirmed (CRu), Partial Response (PR) or Stable Disease (SD)|The DCR was estimated based on the Response Criteria for Non-Hodgkin's Lymphomas (Cheson et al. 1999). DCR was assessed from date of first dose until disease progression or death or start of new anticancer therapy. CR is defined as the disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms based on CT scan or bone marrow biopsy; CRu = the CR criteria is met and a residual lymph node mass greater than 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the product diameter (SPD). PR is >= 50% decrease in SPD of the six largest nodal masses/no new sites of disease. Progressive Disease (PD) is defined as an increase by 25% in longest diameter, new lesion or assessable disease progression. SD=small changes not meeting the above criteria; DCR and its exact 95% CI was estimated for treated participants using the Clopper-Pearson method.|From Date of First Dose until Disease Progression or Death or Start of New Anticancer Therapy (Up to 28 Months)|All participants who received at least one dose of study drug and had evaluable DCR data.|||percentage of participants||95% Confidence Interval|Number
2642075|NCT01739231|Secondary|Part B: Number of Subjects Requiring Early Antibiotic Treatment and Intravenous (IV) Fluids||5 days||||Participants|||Count of Participants
2642076|NCT01739231|Secondary|Part B: Quantity of H10407 Per Gram of Stool on Day 2 Post-challenge||2 days after vaccination||||colony forming units||Standard Deviation|Mean
2642077|NCT01739231|Secondary|Part B: Mean Time to Onset of Diarrhea Among Subjects Who Had Diarrhea|"Defined as mild, moderate, or severe diarrhea, specifically:~Mild diarrhea: 2 or 3grade 3-5 stools totaling 200 g - 400 g, or 1 grade 3-5 stool of >300 g~Moderate diarrhea: 4-5 grade 3-5 stools totaling >200 g or 401 - 800g~Severe diarrhea: > 800g grade 3-5 stool(s)~Grades were defined as follows:~Grade 1: firm, formed (normal) Grade 2: soft, formed (normal) Grade 3: viscous opaque liquid or semi-liquid which assumes the shape of the container Grade 4: watery, non-viscous, opaque liquid which assumes the shape of the container Grade 5: clear or translucent, watery or mucoid liquid which assumes the shape of the container"|5 days|Among subjects who met the protocol definition of diarrhea over the observation period|||hours||Standard Deviation|Mean
2642078|NCT01739231|Secondary|Part B: Number and Percentage of Subjects Who Would Have Reduced Daily Activity|When asking about adverse events, subjects were asked whether their illness resulting from ETEC would have reduced their daily activity because of their illness if they had been vacationing or traveling on business.|5 days||||Participants|||Count of Participants
2642079|NCT01739231|Secondary|Part B: Number of Subjects Experiencing Solicited Reactions Graded as Moderate or Severe|Solicited reactions were generally graded as mild if there was discomfort, but no disruption of normal daily activities; moderate if if discomfort was sufficient to affect normal daily activity and partially relieved with symptomatic treatment; severe if discomfort was sufficient to affect normal daily activity considerably, prevent regular activity, and not relieved with symptomatic treatment.|1 week|Participants in Part A of the study who received at least one dose of the study product.|||Participants|||Count of Participants
2642080|NCT01739231|Secondary|Part B: Median Number of Grade 3-5 Stools Passed Per Volunteer|"Grades were defined as follows:~Grade 1: firm, formed (normal) Grade 2: soft, formed (normal) Grade 3: viscous opaque liquid or semi-liquid which assumes the shape of the container Grade 4: watery, non-viscous, opaque liquid which assumes the shape of the container Grade 5: clear or translucent, watery or mucoid liquid which assumes the shape of the container"|5 days||||stools||Inter-Quartile Range|Median
2642081|NCT01739231|Secondary|Part B: Mean Number of Grade 3-5 Stools Passed Per Volunteer|"Grades were defined as follows:~Grade 1: firm, formed (normal) Grade 2: soft, formed (normal) Grade 3: viscous opaque liquid or semi-liquid which assumes the shape of the container Grade 4: watery, non-viscous, opaque liquid which assumes the shape of the container Grade 5: clear or translucent, watery or mucoid liquid which assumes the shape of the container"|5 days||||stools||Standard Deviation|Mean
2642082|NCT01739231|Secondary|Part B: Median Total Weight of Grade 3-5 Stools Passed Per Volunteer|"Grades were defined as follows:~Grade 1: firm, formed (normal) Grade 2: soft, formed (normal) Grade 3: viscous opaque liquid or semi-liquid which assumes the shape of the container Grade 4: watery, non-viscous, opaque liquid which assumes the shape of the container Grade 5: clear or translucent, watery or mucoid liquid which assumes the shape of the container"|5 days||||grams||Inter-Quartile Range|Mean
2643396|NCT01729156|Primary|VLDL-TG Secretion|Hepatic VLDL-TG secretion assessed by [1-14C] VLDL tracer|90 days||||micromol/min||Standard Deviation|Mean
2642084|NCT01739231|Secondary|Part B: Number and Percentage of Subjects Experiencing Diarrhea of Any Severity|"Defined as mild, moderate, or severe diarrhea, specifically:~Mild diarrhea: 2 or 3grade 3-5 stools totaling 200 g - 400 g, or 1 grade 3-5 stool of >300 g~Moderate diarrhea: 4-5 grade 3-5 stools totaling >200 g or 401 - 800g~Severe diarrhea: > 800g grade 3-5 stool(s)~Grades were defined as follows:~Grade 1: firm, formed (normal) Grade 2: soft, formed (normal) Grade 3: viscous opaque liquid or semi-liquid which assumes the shape of the container Grade 4: watery, non-viscous, opaque liquid which assumes the shape of the container Grade 5: clear or translucent, watery or mucoid liquid which assumes the shape of the container"|5 days||||Participants|||Count of Participants
2642085|NCT01739231|Secondary|Number of Participants Shedding Vaccine Strains Included in ACE527||3 days after the first and second vaccinations|Subjects who received the vaccination and had valid test results.|||Participants|||Count of Participants
2642086|NCT01739231|Secondary|Part A: Number of Participants With Positive Shedding Results for ACE527||Pre- and day 7 post-all vaccinations; and Day 3 post-vaccinations 1 and 2; and 4 weeks post vaccination 3|Subjects who received the vaccination and had valid test results.|||Participants|||Count of Participants
2642087|NCT01739231|Secondary|Part A: Number of Participants Shedding E. Coli on Qualification Plate||Pre- and day 7 post-all vaccinations; and Day 3 post-vaccinations 1 and 2; and 4 weeks post vaccination 3|Subjects who received the vaccination and had valid test results.|||Participants|||Count of Participants
2642088|NCT01739231|Primary|Part B: Number and Percentage of Subjects Experiencing Severe Diarrhea Following H10407 Challenge Strain|"Severe diarrhea was defined as >800 grams of grade 3-5 stools passed over the 120-hour observation period. For episodes starting at or before 120 hours post-challenge, volunteers were followed to resolution and the total stool output weight was considered in determining whether a specific volunteer met the primary definition of severe diarrhea. The end of a diarrheal episode occurred when a volunteer did not pass any grade 3-5 stool in a 24-hour period.~Grades were defined as follows:~Grade 1: firm, formed (normal) Grade 2: soft, formed (normal) Grade 3: viscous opaque liquid or semi-liquid which assumes the shape of the container Grade 4: watery, non-viscous, opaque liquid which assumes the shape of the container Grade 5: clear or translucent, watery or mucoid liquid which assumes the shape of the container"|5 days||||Participants|||Count of Participants
2642089|NCT01739231|Primary|Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)||Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3|Subjects who received the vaccination and had valid test results.|||titer||95% Confidence Interval|Geometric Mean
2642090|NCT01739231|Primary|Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)||Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3|Subjects who received the vaccination and had valid test results.|||fold change||95% Confidence Interval|Geometric Mean
2642091|NCT01739231|Primary|Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 6 (CS6)|Defined as a 2.5-fold rise or greater in geometric mean titer.|Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3|Subjects who received the vaccination and had valid test results.|||Participants|||Count of Participants
2642092|NCT01739231|Primary|Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)||Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3|Subjects who received the vaccination and had valid test results.|||titer||95% Confidence Interval|Geometric Mean
2642093|NCT01739231|Primary|Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)||Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3|Subjects who received the vaccination and had valid test results.|||fold change||95% Confidence Interval|Geometric Mean
2642094|NCT01739231|Primary|Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Surface Antigen 3 (CS3)|Defined as a 2.5-fold rise or greater in geometric mean titer.|Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3|Subjects who received the vaccination and had valid test results.|||Participants|||Count of Participants
2642095|NCT01739231|Primary|Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)||Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3|Subjects who received the vaccination and had valid test results.|||titer||95% Confidence Interval|Geometric Mean
2642096|NCT01739231|Primary|Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)||Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3|Subjects who received the vaccination and had valid test results.|||fold change||95% Confidence Interval|Geometric Mean
2642097|NCT01739231|Primary|Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)|Defined as a 2.5-fold rise or greater in geometric mean titer.|Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3|Subjects who received the vaccination and had valid test results.|||Participants|||Count of Participants
2642098|NCT01739231|Primary|Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)||Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3|Subjects who received the vaccination and had valid test results.|||titer||95% Confidence Interval|Geometric Mean
2642099|NCT01739231|Primary|Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)||Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3|Subjects who received the vaccination and had valid test results.|||fold change||95% Confidence Interval|Geometric Mean
2642100|NCT01739231|Primary|Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin G (IgG) Response to E. Coli Heat Labile Toxin B Subunit (LTB)|Defined as a 2.5-fold rise or greater in geometric mean titer.|Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3|Subjects who received the vaccination and had valid test results.|||Participants|||Count of Participants
2642101|NCT01739231|Primary|Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)||Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3|Subjects who received the vaccination and had valid test results.|||titer||95% Confidence Interval|Geometric Mean
2642103|NCT01739231|Primary|Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)|Defined as a 2.5-fold rise or greater in geometric mean titer.|Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3|Subjects who received the vaccination and had valid test results.|||Participants|||Count of Participants
2642104|NCT01739231|Primary|Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)||Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3|Subjects who received the vaccination and had valid test results.|||titer||95% Confidence Interval|Geometric Mean
2642105|NCT01739231|Primary|Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)||Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3|Subjects who received the vaccination and had valid test results.|||fold change||95% Confidence Interval|Geometric Mean
2642106|NCT01739231|Primary|Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)|Defined as a 2.5-fold rise or greater in geometric mean titer.|Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3|Subjects who received the vaccination and had valid test results.|||Participants|||Count of Participants
2642107|NCT01739231|Primary|Part A: Geometric Mean Titer of Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)||Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3|Subjects who received the vaccination and had valid test results.|||titer||95% Confidence Interval|Geometric Mean
2642108|NCT01739231|Primary|Part A: Geometric Mean Fold Change in Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)||Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3|Subjects who received the vaccination and had valid test results.|||fold change||95% Confidence Interval|Geometric Mean
2642109|NCT01739231|Primary|Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)|Defined as a 2.5-fold rise or greater in geometric mean titer.|Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3|Subjects who received the vaccination and had valid test results.|||Participants|||Count of Participants
2642110|NCT01739231|Primary|Part A: Geometric Mean Titer of Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)||Pre and day 7 post all vaccinations; and 4 weeks post vaccination 3|Subjects who received the vaccination and had valid test results.|||titer||95% Confidence Interval|Geometric Mean
2642111|NCT01739231|Primary|Part A: Geometric Mean Fold Change in Antibody in Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)||Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3|Subjects who received the vaccination and had valid test results.|||fold change||95% Confidence Interval|Geometric Mean
2642112|NCT01739231|Primary|Part A: Number and Percentage of Subjects With Positive Serum ELISA Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)|Defined as a 2.5-fold rise or greater in geometric mean titer.|Day 7 post-all vaccinations; pre-vaccination 2 and 3; week 4 post-vaccination 3|Subjects who received the vaccination and had valid test results.|||Participants|||Count of Participants
2642113|NCT01739231|Primary|Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)||Pre and day 7 post all vaccinations; day 3 post-vaccination 1 and 2; week 4 post vaccination 3|Subjects who received the vaccination and had valid test results.|||titer||95% Confidence Interval|Geometric Mean
2642114|NCT01739231|Primary|Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)||Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4|Subjects who received the vaccination and had valid test results.|||fold change||95% Confidence Interval|Geometric Mean
2642115|NCT01739231|Primary|Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 6 (CS6)|Defined as a four-fold rise or greater in geometric mean titer.|Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4|Subjects who received the vaccination and had valid test results.|||Participants|||Count of Participants
2642116|NCT01739231|Primary|Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)||Pre all vaccinations; day 3 post-vaccination 1 and 2; day 7 post all vaccinations; 4 weeks post-vaccination 3|Subjects who received the vaccination and had valid test results.|||titer||95% Confidence Interval|Geometric Mean
2642117|NCT01739231|Primary|Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)||Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4|Subjects who received the vaccination and had valid test results.|||fold change||95% Confidence Interval|Geometric Mean
2642118|NCT01739231|Primary|Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Surface Antigen 3 (CS3)|Defined as a four-fold rise or greater in geometric mean titer.|Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4|Subjects who received the vaccination and had valid test results.|||Participants|||Count of Participants
2642119|NCT01739231|Primary|Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)||Pre and day 7 post all vaccinations; day 3 post-vaccination 1 and 2; week 4 post vaccination 3|Subjects who received the vaccination and had valid test results.|||titer||95% Confidence Interval|Geometric Mean
2642120|NCT01739231|Primary|Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)||Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4|Subjects who received the vaccination and had valid test results.|||fold change||95% Confidence Interval|Geometric Mean
2643397|NCT01729156|Primary|Hepatic Fatty Acid Uptake|Hepatic fatty acid uptake assessed by C11-palmitate PET|90 days||||micromol/ml/min||Standard Deviation|Mean
2642121|NCT01739231|Primary|Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to Enterotoxigenic Escherichia Coli (ETEC) Colonization Factor 1 (CFA/I)|Defined as a four-fold rise or greater in geometric mean titer.|Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4|Subjects who received the vaccination and had valid test results.|||Participants|||Count of Participants
2642122|NCT01739231|Primary|Part A: Geometric Mean Titer of Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)||Pre and day 7 post all vaccinations; day 3 post-vaccination 1 and 2; week 4 post vaccination 3|Subjects who received the vaccination and had valid test results.|||titer||95% Confidence Interval|Geometric Mean
2642123|NCT01739231|Primary|Part A: Geometric Mean Fold Change in Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)||Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4|Subjects who received the vaccination and had valid test results.|||fold change||95% Confidence Interval|Geometric Mean
2642124|NCT01739231|Primary|Part A: Number and Percentage of Subjects With Positive Antibody in Lymphocyte Supernatant (ALS) Immunoglobulin A (IgA) Response to E. Coli Heat Labile Toxin B Subunit (LTB)|Defined as a four-fold rise or greater in geometric mean titer.|Vaccination 1 Day 3 and 7; Vaccination 2 pre-vaccination, Day 3, and Day 7; Vaccination 3 pre-vaccination, Day 7, and Week 4|Subjects who received the vaccination and had valid test results.|||Participants|||Count of Participants
2642125|NCT01739231|Primary|Part A: Number of Solicited Reactions|Solicited reactions were collected 1 week after each vaccination.|up to 1 week after each vaccination (at 0, 1, and 2 months)|Participants in Part A of the study who received at least one dose of the study product.|||Participants|||Count of Participants
2642126|NCT01739231|Primary|Part A: Number of Participants Experiencing Unsolicited Adverse Events, by Severity and Relationship to Vaccination|Unsolicited adverse events were collected throughout Part A of the study, were graded for severity, and assessed for relationship to vaccine. Generally, mild severity is discomfort with no disruption of normal daily activities and relieved with or without symptomatic treatment; moderate severity is discomfort sufficient to reduce or affect normal daily activity somewhat and only partially relieved with symptomatic treatment; and severe is discomfort sufficient to reduce or affect normal daily activity considerably; prevents regular activities, and not relieved with symptomatic treatment. Additional description of severity for diarrhea, body temperature, and vomiting is described in the protocol.|up to 1 month after last vaccination (3 months)|Participants in Part A of the study who received at least one dose of the study product.|||Participants|||Count of Participants
2642127|NCT01739231|Primary|Part A: Number of Serious Adverse Events and Adverse Events Leading to Withdrawal|Unsolicited adverse events were collected throughout Part A of the study, were graded for severity, and assessed for relationship to vaccine. Withdrawal from the study due to adverse event was determined at the discretion of the study staff.|up to 1 month after last vaccination (3 months)|Participants in Part A of the study who received at least one dose of the study product.|||adverse events|||Number
2642128|NCT01738984|Other Pre-specified|Return to Drinking Between Baseline and 12 Weeks|drinking status measured via online survey taken at baseline and 12 week|12 weeks|number of participants who never/rarely drank at baseline but reported drank 1 or more drink per week at 12 weeks.|||participants|||Number
2642129|NCT01738984|Secondary|Number Who Returned to Smoking From Baseline and 12 Weeks|change in smoking status between baseline and 12 week assessment will be collected via survey at baseline and at the 12 week survey|12 weeks|Number of participants who were not smoking at baseline but reported returned to smoking on 12 week survey.|||participants|||Number
2642130|NCT01738984|Primary|Minutes Per Week of Moderate-to-Vigorous Physical Activity (MPVA Min/wk) Assessed at 12 Weeks|physical activity will be obtained via online surveys at the 12 week assessment point|12 weeks||||MVPA minutes per week||95% Confidence Interval|Mean
2642131|NCT01738971|Other Pre-specified|Qualitative Outcomes : Pharmacist's Views on Interventions and Any Study Difficulties||12 months|||||||
2642132|NCT01738971|Other Pre-specified|Qualitative Outcomes : Women's Views on Different Measures to Determine Validity of Self-reported Data on Contraceptive Use , Determined by in Depth Interviews.||8 months|||||||
2642133|NCT01738971|Secondary|Proportion of Women Who Agree to Participate Who Can be Successfully Contacted||8 months||||participants|||Number
2642134|NCT01738971|Secondary|Completeness (Quality) of Data Recorded by Pharmacists (Numbers of Women Attending for EC,Demographics of All Attendees- Age, Ethnicity Etc)||8 months|||||||
2642135|NCT01738971|Secondary|Pharmacy Recruitment Rates|Proportion of participants that pharmacists were successful in recruiting during the specified 8 month recruitment time period. Initial target set to recruit 60 participants to each arm/group.|8 months||||participants|||Number
2642136|NCT01738971|Primary|Self-reported Uptake of Effective Ongoing Contraception (Not Condoms)|Outcome measure identified when participants conducted for agreed telephone interview 6-8 weeks following recruitment to study. Participants asked via telephone what method of contraception, if any, there were currently using.|6-8 weeks after EC|A small number of participants were identified who had been recruited to the study although were already using an effective method of contraception (i.e. using a contraceptive pill but had forgot to take), and continued to use the same method at follow-up. These participants were excluded from analysis.|||participants|||Number
2642137|NCT01738919|Secondary|Flexion of the Distal Interphalangeal Joint.|Flexion of the distal interphalangeal joint. Measured with goniometer.|6 months||||degrees||95% Confidence Interval|Mean
2642138|NCT01738919|Secondary|DASH|Questionary: Disabilities of the Arm, Shoulder and Hand Danish version (qDASH). Scale range 0-100, with 0 indicating no disability.|6 month||||units on a scale||Inter-Quartile Range|Median
2642139|NCT01738919|Secondary|Complications|Number of participants with nail deformities.|6 month||||participants|||Number
2642140|NCT01738919|Secondary|Bump|Number of participants with the presence of a bump on the fracture-site.|6 month||||participants|||Number
2642141|NCT01738919|Secondary|Pain|Pain in the affected join. Pain intensity were reported on a numeric rating scale (NRS), from 0-10, with 0 indicating no pain.|6 month||||units on a scale||Inter-Quartile Range|Median
2642144|NCT01738750|Primary|Choice Based on Cost|The group given information related to the cost of each surgical procedure will more often choose the less expensive procedure as compared to those not given cost information|Outcome assessed prior to surgical procedure with data presented within 1 year||||percentage of open appendectomy|||Number
2642145|NCT01738737|Secondary|Change From Baseline in Timed Get Up and Go Test|Higher values represent worse outcomes The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks||||seconds||Inter-Quartile Range|Median
2642146|NCT01738737|Secondary|Change From Baseline in Lequesne Functional Questionnaire|The scale varies from 0 to 24. Higher values represent worse outcomes The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks||||units on a scale||Inter-Quartile Range|Median
2642147|NCT01738737|Secondary|Change From Baseline in Range of Motion of Flexion of the Knee|Higher values represent better outcomes The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks||||degress||Inter-Quartile Range|Median
2642148|NCT01738737|Secondary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index|The scale varies from 0 to 96. Higher values represent worse outcomes. The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks||||units on a scale||Inter-Quartile Range|Median
2642149|NCT01738737|Primary|Change From Baseline in Visual Analogue Scale for Pain|The scale varies from 0 to 10. Higher values represent worse outcomes. The assessment will be done in the patient's first evaluation and after each intervention.|Baseline and post-intervention, up to 11 weeks||||units on a scale||Standard Deviation|Mean
2642150|NCT01738698|Secondary|Ambulatory Blood Pressure Monitoring (ABPM)||Baseline and Weeks 4 and 10|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2642151|NCT01738698|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2642152|NCT01738698|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)||Up to 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2642153|NCT01738698|Secondary|Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale||Up to 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2642154|NCT01738698|Secondary|Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale||Baseline and week 12|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2642155|NCT01738698|Secondary|Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2642156|NCT01738698|Secondary|Change From Baseline in Social Functioning Scale (SFS) at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2642157|NCT01738698|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2642158|NCT01738698|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2642159|NCT01738698|Secondary|Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2642160|NCT01738698|Secondary|Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2642161|NCT01738698|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2642162|NCT01738698|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2642163|NCT01738698|Secondary|Change From Baseline in the Personal and Social Performance Scale (PSP) Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2642164|NCT01738698|Primary|Change From Baseline in Negative Symptom Assessment - 16-item (NSA-16) Total Score at 12 Weeks||Baseline and 12 weeks|Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized||||||
2642165|NCT01738672|Other Pre-specified|Crossover To Epidural|Participants crossing over from nitrous oxide to epidural.|Initiation of nitrous oxide to completion of delivery.|Data are included for all participants from which they were collected.|||participants|||Number
2642166|NCT01738672|Other Pre-specified|Participant Satisfaction|Participant reported score of satisfaction with nitrous oxide for labor analgesia, using a numerical rating scale (NRS) ranging from completely dissatisfied (0) to completely satisfied (100).|24 hours after delivery|Data are included for all participants from which they were collected.|||units on a scale||Full Range|Median
2642167|NCT01738672|Other Pre-specified|Emesis|Participant reported emesis (yes or no).|During administration of nitrous oxide|Data are included for all participants from which they were collected.|||participants experiencing emesis|||Number
2642168|NCT01738672|Other Pre-specified|Nausea|Participant reported nausea score, using a numerical rating scale (NRS) ranging from no nausea (0) to severe nausea (10).|At baseline, and at 1 hour after initiation of nitrous oxide|Data are included for all participants from which they were collected.|||units on a scale||Standard Deviation|Mean
2643398|NCT01729156|Primary|Hepatic Fatty Acid Reesterification|Hepatic fatty acid reesterification assessed by C11-palmitate PET|90 days||||micromol/ml/min||Standard Deviation|Mean
2642169|NCT01738672|Other Pre-specified|Anxiety|Participant reported anxiety score, using a numerical rating scale (NRS) ranging from no anxiety (0) to severe anxiety (10).|At baseline, and at 1 hour after initiation of nitrous oxide|Data are included for all participants from which they were collected.|||units on a scale||Standard Deviation|Mean
2642170|NCT01738672|Primary|Labor Pain|Participant reported pain score, using a numerical rating scale (NRS) ranging from no pain (0) to severe pain (10).|At baseline, and at 1 hour after initiation of nitrous oxide|Data are included for all participants from which they were collected.|||units on a scale||Standard Deviation|Mean
2642171|NCT01738646|Secondary|Median Overall Survival (OS)|Overall survival is defined as the time in months from the start of protocol treatment until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.|3 Years|Intent-to-treat|||months||95% Confidence Interval|Median
2642172|NCT01738646|Secondary|Median Progression-free Survival (PFS)|Progression-free survival is defined as the time in months from the start of protocol treatment until the date of progression or death if death occurred before progression. If the participant is alive and progression-free, PFS will be censored at the date of last follow-up. Kaplan-Meier methods will be used to estimate progression-free survival.|3 Years|Intent-to-treat|||months||95% Confidence Interval|Median
2642173|NCT01738646|Secondary|Percentage of Participants Who Experience Grade 3 or Greater, Treatment Related, Non-hematologic Toxicities.|The percentage of participants who experience grade 3 or greater, treatment-related, non-hematologic toxicities will be calculated.|2.7 Years|Intent-to-treat|||percentage of participants|||Number
2642174|NCT01738646|Secondary|Radiographic Response|The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria will be determined. Complete Response (CR) is defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) is defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments are done at baseline and the end of every second cycle (every 8 weeks) thereafter.|3 Years|Intent-to-treat|||percentage of participants||95% Confidence Interval|Number
2642175|NCT01738646|Primary|Six-month Progression-free Survival (PFS6)|The percentage of participants alive and progression-free at 6 months after the start of study treatment will be determined. Based on Response Assessment in Neuro-Oncology (RANO) criteria, progression is defined as a ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; significant increase in T2/FLAIR; any new lesion; clear clinical deterioration not attributable to other causes apart from the tumor; failure to return for evaluation as a result of death or deteriorating condition; or clear progression of non-measurable disease. PFS6 will be calculated from the date study treatment started until the date of progression or death, or the date of last follow-up if participants are alive without progression. Kaplan-Meier methods will be used to estimate survival.|6 months|Intent-to-treat|||percentage of participants||95% Confidence Interval|Number
2642176|NCT01738594|Other Pre-specified|Proteasome Activity Will be Measured in Peripheral Blood and Tumor Tissue Samples to Observe Proteasome Inhibition While on Treatment|Proteasome inhibition will be measured by evaluating proteasome activity in blood and tumor tissue biopsy specimens while on treatment of carfilzomib alone as well as carfilzomib with romidepsin.|Blood is collected before & after carfilzomib dosing during cycle 1 (days 1, 2, & 8) & cycle 2 (day 1) & Tumor tissue samples obtained at baseline, 1-4 hours post-first dose of carfilzomib (cycle 1 day 1) & 1-4 hours post-carfilzomib on cycle 1 day 8|Data was not collected for this outcome measure due to the study terminating early due to slow accrual.||||||
2642177|NCT01738594|Secondary|Time to Progression (TTP) of the Disease When Treated With Carfilzomib Alone and When Taken With Romidepsin|The time to progression (TTP) will be measured as the time from the first dose of study therapy until the point at which disease is determined to have progressed or patients discontinue therapy for toxicity. To measure time to progression, the study treatment will be evaluated based on skin biopsy, CT scans, and blood tests at the beginning of the study as well as every 56 days (2 cycles).|Baseline and every 56 days (2 cycles) until disease progression or toxicity call for discontinuation of treatment|Data was not collected for this outcome measure due to the study terminating early due to slow accrual.||||||
2642178|NCT01738594|Secondary|Duration of Response of the Disease When Treated With Carfilzomib Alone and When Taken With Romidepsin|Duration of response will be defined as the time from the point at which response is achieved until the point of disease progression. The duration of response of the study treatment will be evaluated based on skin biopsy, CT scans, and blood tests at the beginning of the study as well as every 56 days (2 cycles).|Baseline and every 56 days (2 cylces) until disease progression|Data was not collected for this outcome measure due to the study terminating early due to slow accrual.||||||
2642179|NCT01738594|Secondary|Overall Response Rate (ORR) of the Disease When Treated With Carfilzomib Alone and When Taken With Romidepsin|Overall Response Rate (ORR) is defined as number of patients who's best response is complete response or partial response. Response will be categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The overall response rate of the study treatment will be evaluated based on skin biopsy, CT scans, and blood tests at the beginning of the study as well as every 56 days (2 cycles).|Baseline and every 56 days (2 cycles) while on treatment and up to 4 cycles|Data was not collected for this outcome measure due to study terminating early due to slow accrual.||||||
2642187|NCT01738581|Primary|Change From Baseline in Global Rating of Change at Posttest (Day 5)|Symptom severity was assessed using the global rating of change (GROC). For the GROC, participants were asked to identify between one to three functions most impacted by focal hand dystonia. At posttest 1 they were then asked to select a rating of perceived change that represented the level of function compared to baseline. Perceived change consisted of a ±7 point Likert scale (+7= a very great deal better, 0= no change, -7= a very great deal worse).|Baseline and Posttest|All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.|||units on a scale||Full Range|Mean
2643399|NCT01729156|Primary|Hepatic Fatty Acid Oxidation|Hepatic fatty acid oxidation assessed by dynamic C11-palmitate PET|90 days||||micromol/ml/min||Standard Deviation|Mean
2642180|NCT01738594|Primary|Number of Patients With Dose Limiting Toxicities (DLTs)|"To determine the maximum tolerated dose (MTD) by assessing the adverse events experienced by patients of both carfilzomib alone and when taken with romidepsin for dose limiting toxicities (DLT) on days 1 and 15 of the first 28 days of treatment. Toxicities will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0.~DLT is defined as any of the following:~Grade ≥ 2 neuropathy with pain Grade ≥ 3 non-hematologic toxicity Grade ≥ 3 nausea, vomiting, or diarrhea not controlled Grade ≥ 4 fatigue persisting for > 7 days Grade 4 neutropenia (ANC < 500/mm3) occurring for >7 days Febrile neutropenia [ANC < 1000/mm3 with fever Grade ≥ 3 thrombocytopenia persisting for > 7 days Grade ≥ 3 thrombocytopenia associated with bleeding Any toxicity requiring a dose reduction within Cycle 1 Inability to receive Cycle 2, Day 1 dose due to drug related toxicity persisting from Cycle 1 or drug-related toxicity newly encountered on Cycle 2, Day 1"|During the first 28 days (1 cycle=28 days) of treatment.|Study terminated early due to slow accrual and not all cohorts enrolled patients. Only number of patients that experienced DLTs are shown below for arms and cohorts that enrolled as data could not be collected regarding MTD|||Participants|||Count of Participants
2642181|NCT01738581|Secondary|Change From Baseline in Physical Function at Posttest (Day 5)|"Participants completed the full SF-36 assessment with subsection of interest: physical functioning."|Baseline and Posttest|All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.|||Participants|||Count of Participants
2642182|NCT01738581|Secondary|Change From Baseline for Physician Rated Impairment at Posttest (Day 5)|"Video recordings were made as participants wrote on a pad of paper with pen. Participants were asked to draw a series of 10 loops across the pad of paper followed by The dog is barking and their signature, each repeated four times. A physician blinded to participant allocation rated recordings. Scoring criteria were adapted from a standardized writer's cramp rating scale (WCRS) (Wissel et al., 1996), rating pathological flexion or extension at the wrist, fingers and elbow, presence of tremor, dystonic posture, writing speed and latency of dystonic symptoms. Final scores are expressed as a rating listed as a movement score."|Baseline and Posttest|All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.|||Participants|||Count of Participants
2642183|NCT01738581|Secondary|Change From Baseline for Pressure During Hand Writing at Posttest (Day 5)|"Digitized handwriting was assessed using a computerized tablet (WACOM Co., Ltd., japan) with MovAlyzeR® (Neuroscript LLC, Tempe, AZ) hardware and software. Participants used a custom modified digitized pen (Kiko Software, Netherlands) to write in a self-selected pace and style on the tablet with real-time visual feedback. Writing tasks included My country tis of thee at a self-selected pace, repeated eight times. Data were sampled at 215 Hz (resolution: 5080 lpi, accuracy: ±0.01 pressure range: 0-800 g). Writing samples were segmented by points of minimal velocity into single strokes for analysis. Pressure for each stroke was automatically calculated within the software."|Baseline and Posttest|One participant that did not display symptoms affecting handwriting and did not participate in the handwriting analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.|||Participants|||Count of Participants
2642184|NCT01738581|Secondary|Change From Baseline in Cortical Silent Period at Posttest (Day 5)|"Cortical silent period (CSP) testing was completed during an isometric contraction of the target muscle whereby the motor evoked potential is followed by a short duration of electromyographic quiescence. The maximal voluntary contraction for finger abduction was recorded using a custom strain gauge placed around the index finger. Real-time visual feedback was given on a laptop screen to project the force produced by the participant and 20% of the maximum of three trials was calculated and displayed on a target line. For the CSP, participants were asked to contract until the target line was met, then a single transcranial magnetic stimulation pulse was delivered to the motor cortex. Ten trials were collected with a short rest period to prevent fatigue.~CSP duration was calculated in milliseconds (ms). CSP EMG data were first rectified, and then a 10-ms moving average calculation was applied to the data. The onset of the CSP was set as the time point of the delivery of the TM"|Baseline and Posttest|All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.|||Participants|||Count of Participants
2642185|NCT01738581|Secondary|Change From Baseline in Sensation at Posttest (Day 5)|"Examinations included two point discrimination. Two-point discrimination threshold was completed using a Disk-Criminator™. Participants were asked to reply one or two after each presentation. Static and dynamic stimuli were presented to the index and ring fingers bilaterally, meaning it was presented as a static stimuli or it was slowly swept across the skin (dynamic)."|Baseline and Posttest|All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.|||Participants|||Count of Participants
2642186|NCT01738581|Secondary|Change From Baseline in Arm Dystonia Disability Scale at Posttest (Day 5)|The Arm Dystonia Disability Scale (ADDS) is a survey where participants rate task difficulty for activities such as writing, handling utensils, and buttoning on a scale of 1-4 (1 = no difficulty ,4 = not able or marked difficulty). This is a subjective assessment of impairment due to focal hand dystonia. Scores are determined using an equation: total points scored, divided by the maximum possible (23), multiplied by the quotient by 90 and subtract from 90%. Scores range from 0%-90% with higher scores indicating more function.|Baseline and Posttest|All participants who completed the first phase were included in the analysis. Data were only analyzed in the first intervention period of the study because there was a lack of a washout effect between periods. This lack of washout made data from the second intervention period unreliable.|||percentage of function||Standard Deviation|Mean
2642197|NCT01738503|Primary|Norbuprenorphine PK: Accumulation Index in Terms of Maximum Observed Plasma Drug Concentration (Rac(Cmax))|Accumulation index in terms of Cmax calculated as ratio of Cmax Injection 4/ Cmax Injection 1.|Days 1-28, 85-113|PK population of participants with data at both timepoints|||ratio||Standard Deviation|Mean
2642188|NCT01738503|Secondary|Percentage of Urine Drug Screen Samples Negative for Opioids|"Urine samples were screened for the following drugs:~opiates~cocaine~amphetamines~methadone~cannabinoids~barbiturates~buprenorphine. Buprenorphine was only included in the urine drug screen at screening and Day -14 to determine if the subject had used any buprenorphine-containing products prior to the start of SUBUTEX SL tablet dosing.~benzodiazepines~methamphetamine~phencyclidine~Urine drug screens were run every day when the participant was an inpatient; every 2-3 days when the participant was an outpatient. Drug screens were run less often for those participants in the PET substudy."|Day 1 to End of Study (up to day 365)|Safety population|||percentage of total urine drug samples||Standard Deviation|Mean
2642189|NCT01738503|Secondary|Columbia Suicide Severity Rating Scale (C-SSRS): Severity|The scale used in the C-SSRS is a continuous variable ranging from 0 (no suicidal ideation present) to 5 (active ideation with specific plan and intent). Only participants with suicidal ideation (scale of 1-5) are reported. 1=desire to be dead to 5=active ideation with specific plan and intent.|Screening (summary of lifetime), Screening (last 6 months), Day 65, Day 113, End of Study (up to day 365)|PD population|||units on a scale||Standard Deviation|Mean
2642190|NCT01738503|Secondary|Change From Baseline in the Clinical Global Impression Improvement (CGI-I) Scale on Days 7, 29, 57, 85 and 141|"The CGI-I is a 7-item scale completed by the clinician used to rate their impression of how much the participant has improved over a baseline state. The total range is 1 (very much improved) to 7 (very much worse).~Baseline was defined as value from Day 1. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing (not applicable for Day 7) and reported as change from baseline values.~Negative change from baseline values indicate an improvement."|Baseline (Day 1), Days 7, 29, 57, 85, 141|The pharmacodynamic (PD) population included subjects in Cohorts 1 – 6 who were dosed with RBP 6000 and had at least 1 post-dose value of the PD parameter. One participant from Group 6 did not have a baseline evaluation.|||units on a scale||Standard Deviation|Mean
2642191|NCT01738503|Secondary|Change From Baseline in the Clinical Global Impression Severity (CGI-S) Scale on Days 1, 7, 29, 57, 85 and 141|"The CGI-S is a 7-item scale completed by the clinician used to rate the severity of symptoms. The total range is 1 (normal, not at all ill) to 7 (most extremely ill).~Baseline was defined as value from screening (Day -13). The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing (not applicable for Day 7) and reported as change from baseline values.~Negative change from baseline values indicate a lessening of the severity of symptoms."|Baseline (screening Day -15), Days 1, 7, 29, 57, 85, 141|The pharmacodynamic (PD) population included subjects in Cohorts 1 – 6 who were dosed with RBP 6000 and had at least 1 post-dose value of the PD parameter. One participant from Group 2 did not have a baseline evaluation.|||units on a scale||Standard Deviation|Mean
2642192|NCT01738503|Secondary|Change From Baseline in the Clinical Opioid Craving Visual Analog Scale (VAS) Total Score Prior to Injections 1, 2, 3, 4 and 6|"The Total Score was the sum of 10 questions regarding cravings each ranging from 0 (no craving) - 10 (extreme craving) for a total range from 0 (no cravings) to 100 (most intense craving I have ever had).~Baseline was defined as the peak (maximum) value from screening to study Day -13 pre-SUBUTEX dose. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing and reported as change from baseline values.~Negative change from baseline values indicate a lessening of craving symptoms."|Baseline (screening to Day -13), Days -1, 1, 29, 57, 85 141|The pharmacodynamic (PD) population included subjects in Cohorts 1 – 6 who were dosed with RBP 6000 and had at least 1 post-dose value of the PD parameter.|||units on a scale||Standard Deviation|Mean
2642193|NCT01738503|Secondary|Change From Baseline in the Subjective Opiate Withdrawal Scale (SOWS) Prior to Injections 1, 2, 3, 4 and 6|"The Subjective Opiate Withdrawal Scale (SOWS) contains 16 symptoms whose intensity the participant rates on a scale of 0 (not at all) to 4 (extremely) for a full scale of 0 (no withdrawal symptoms) to 64 (extreme withdrawal symptoms).~Baseline was defined as the peak (maximum) value from screening to study Day -13 pre-SUBUTEX dose. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing and reported as change from baseline values.~Negative change from baseline values indicate a lessening of withdrawal symptoms."|Baseline (screening to Day -13), Days -1, 1, 29, 57, 85 141|The pharmacodynamic (PD) population included subjects in Cohorts 1 – 6 who were dosed with RBP 6000 and had at least 1 post-dose value of the PD parameter.|||units on a scale||Standard Deviation|Mean
2642194|NCT01738503|Secondary|Change From Baseline in the Clinical Opiate Withdrawal Scale (COWS) Prior to Injections 1, 2, 3, 4 and 6|"COWS is an 11-item instrument used to assess symptoms of opioid withdrawal (Wesson et al., 1999). The score is the sum of the responses for a total range of 0-48. The COWS is commonly used by clinicians treating patients with buprenorphine to monitor the severity of withdrawal. COWS scores below 5 are considered not indicative of withdrawal. Scores from 5 to 12 are considered mild withdrawal; from 13 to 24 moderate withdrawal; 25 to 36 moderate/severe withdrawal, and 37-48 severe withdrawal. Each participant was to be assessed by the same qualified and trained individuals throughout the course of the study as much as possible.~Baseline was defined as the peak (maximum) value from screening to study Day -13 pre-SUBUTEX dose. The baseline score is reported as the mean of observed values. Other measurements were taken prior to dosing and reported as change from baseline values.~Negative change from baseline values indicate a lessening of withdrawal symptoms."|Baseline (screening to Day -13), Days -1, 1, 29, 57, 85 141|The pharmacodynamic (PD) population included subjects in Cohorts 1 – 6 who were dosed with RBP 6000 and had at least 1 post-dose value of the PD parameter.|||units on a scale||Standard Deviation|Mean
2642195|NCT01738503|Primary|Norbuprenorphine PK: Terminal Phase Half Life (t1/2) Calculated For Injection 4|The terminal phase half life calculated for Injection 4 in subjects not participating in PET imaging sub-study. The t1/2 was reported only if the coefficient of determination R2 was at least 0.8.|Days 85-113, 141-197|PK population of participants whose data met requirements.|||hours||Standard Deviation|Mean
2642196|NCT01738503|Primary|Norbuprenorphine PK: Area Under Plasma Concentration Time Curve From Time Zero Of Injection 4 and 6 (AUC0-∞)|"Area under plasma concentration time curve from time zero of Injection 4 extrapolated to infinity; calculated for Injection 4 and 6 (last injection) in subjects not participating in PET imaging sub-study only as:~(AUC0-∞ was reported if the coefficient of determination R2 was at least 0.8 and the extrapolated area is less than 25%). A minimum of 5 data points was required. AUC up to the last measurable concentration (AUClast) was calculated by using the linear trapezoidal rule."|Days 85-113, 141-197|PK population of participants whose data met requirements.|||hr*ng/mL||Standard Deviation|Mean
2642198|NCT01738503|Primary|Norbuprenorphine PK: Accumulation Index in Terms of Area Under the Curve (Rac(AUC))|Accumulation index in terms of AUC calculated as ratio of AUCtau Injection 4/ AUCtau Injection 1. AUCtau = area under plasma concentration time curve over the dosing interval tau (for SC RBP-6000, tau=28 days).|Days 1-28, 85-113|PK population of participants with data at both timepoints|||ratio||Standard Deviation|Mean
2642199|NCT01738503|Primary|Norbuprenorphine PK: Time to Maximum Buprenorphine Plasma Concentration (Tmax)|"Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||hours||Full Range|Median
2642200|NCT01738503|Primary|Norbuprenorphine PK: Swing of Plasma Concentrations|"The swing of norbuprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cmin within the dosing interval.~Cmax=maximum plasma concentration Cmin=minimum plasma concentration~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||percentage of Cmin||Standard Deviation|Mean
2642201|NCT01738503|Primary|Norbuprenorphine PK: Minimum Observed Plasma Concentration (Cmin)|"Minimum observed plasma concentration, determined directly from individual concentration time data.~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||ng/mL||Standard Deviation|Mean
2642202|NCT01738503|Primary|Norbuprenorphine PK: Maximum Observed Plasma Concentration (Cmax)|"Maximum observed plasma concentration, determined directly from individual concentration time data.~Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||ng/mL||Standard Deviation|Mean
2642203|NCT01738503|Primary|Norbuprenorphine PK: Average Plasma Concentration (Cavg)|"Cavg was defined as the AUC (timeframe)/timeframe. For example, the sublingual steady-state Cavg reading on Day -1 = AUC0-24/ 24 hours~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||ng/mL||Standard Deviation|Mean
2642213|NCT01738503|Primary|Buprenorphine PK: Minimum Observed Plasma Concentration (Cmin)|"Minimum observed plasma concentration, determined directly from individual concentration time data.~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||ng/mL||Standard Deviation|Mean
2642204|NCT01738503|Primary|Norbuprenorphine PK: Area Under Plasma Concentration Time Curves (AUC)|"AUC calculated using the linear trapezoidal rule and requiring a minimum of 5 data points for each time range.~Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||hr*ng/mL||Standard Deviation|Mean
2642205|NCT01738503|Primary|Norbuprenorphine PK: % Fluctuation|"% Fluctuation was defined as the degree of fluctuation of norbuprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cavg*100, expressed as a percentage. Cmax=maximum plasma concentration Cmin=minimum plasma concentration Cavg = average plasma concentration~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||% of average concentration||Standard Deviation|Mean
2642206|NCT01738503|Primary|Buprenorphine PK: Terminal Phase Half Life (t1/2) Calculated For Injection 4|The terminal phase half life calculated for Injection 4 in subjects not participating in PET imaging sub-study. The t1/2 was reported only if the coefficient of determination R2 was at least 0.8.|Days 85-113|PK population of participants whose data met requirements.|||hours||Standard Deviation|Mean
2642207|NCT01738503|Primary|Buprenorphine PK: Area Under Plasma Concentration Time Curve From Time Zero Of Injection 4 (AUC0-∞)|"Area under plasma concentration time curve from time zero of Injection 4 extrapolated to infinity; calculated for Injection 4 (last injection) in subjects not participating in PET imaging sub-study only as:~(AUC0-∞ was reported if the coefficient of determination R2 was at least 0.8 and the extrapolated area is less than 25%). A minimum of 5 data points was required. AUC up to the last measurable concentration (AUClast) was calculated by using the linear trapezoidal rule."|Days 85-113|PK population of participants whose data met requirements.|||hr*ng/mL||Standard Deviation|Mean
2642208|NCT01738503|Primary|Buprenorphine PK: Apparent Clearance at Steady-State (CLss/F) Following Injections 4 and 6|Apparent clearance at steady-state (CLss/F) = Dose / AUCtau (tau was 28 days).|Days 85-113, 141-169|PK population|||L/hour||Standard Deviation|Mean
2642209|NCT01738503|Primary|Buprenorphine PK: Accumulation Index in Terms of Maximum Observed Plasma Drug Concentration (Rac(Cmax))|Accumulation index in terms of Cmax calculated as ratio of Cmax Injection 4/ Cmax Injection 1.|Days 1-28, 85-113|PK population of participants with data at both timepoints|||ratio||Standard Deviation|Mean
2642210|NCT01738503|Primary|Buprenorphine PK: Accumulation Index in Terms of Area Under the Curve (Rac(AUC))|Accumulation index in terms of AUC calculated as ratio of AUCtau Injection 4/ AUCtau Injection 1. AUCtau = area under plasma concentration time curve over the dosing interval tau (for SC RBP-6000, tau=28 days).|Days 1-28, 85-113|PK population of participants with data at both timepoints|||ratio||Standard Deviation|Mean
2642211|NCT01738503|Primary|Buprenorphine PK: Time to Maximum Buprenorphine Plasma Concentration (Tmax)|"Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||hours||Full Range|Median
2642212|NCT01738503|Primary|Buprenorphine PK: Swing of Plasma Concentrations|"The swing of buprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cmin within the dosing interval.~Cmax=maximum plasma concentration Cmin=minimum plasma concentration~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||percentage of Cmin||Standard Deviation|Mean
2642276|NCT01737879|Primary|Mean Hemoglobin Concentration During the Evaluation Period|"The hemoglobin concentrations during the evaluation period after the conversion to epoetin alfa were to be averaged for each participant and then summarized over all participants.~No participant reached the evaluation period, therefore, the primary efficacy endpoint could not be evaluated."|Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).|||||||
2642214|NCT01738503|Primary|Buprenorphine PK: Maximum Observed Plasma Concentration (Cmax)|"Maximum observed plasma concentration, determined directly from individual concentration time data.~Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||ng/mL||Standard Deviation|Mean
2642215|NCT01738503|Primary|Buprenorphine PK: Average Plasma Concentration (Cavg)|"Cavg was defined as the AUC (timeframe)/timeframe. For example, the sublingual steady-state Cavg reading on Day -1 = AUC0-24/ 24 hours~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||ng/mL||Standard Deviation|Mean
2642216|NCT01738503|Primary|Buprenorphine PK: Area Under Plasma Concentration Time Curves (AUC)|"AUC calculated using the linear trapezoidal rule and requiring a minimum of 5 data points for each time range.~Results are reported across four timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading at hours 0-24.~Initial Burst Parameters (Days 1-2 relative to RBP-6000 injections 1, 4 and 6) at hours 0-48~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6) at hours 48-672~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6) at hours 0-24, hours 0-672~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||hr*ng/mL||Standard Deviation|Mean
2642217|NCT01738503|Primary|Buprenorphine PK: % Fluctuation|"% Fluctuation was defined as the degree of fluctuation of buprenorphine plasma concentrations calculated as (Cmax-Cmin)/Cavg*100, expressed as a percentage. Cmax=maximum plasma concentration Cmin=minimum plasma concentration Cavg = average plasma concentration~Results are reported across three timeframes:~Sublingual Period (Day -1 dose of SUBUTEX): a steady-state reading.~Plateau Parameters (Days 3-29 relative to RBP-6000 injections 1, 4 and 6)~Overall Parameters (Days 1-29 relative to RBP-6000 injections 1, 4 and 6)~The PK sampling schedule was~hour 0 (predose) on days -7 to -1,~hours 0.5, 1,2,4,6, 8,12, 24 post-dose on Day -1~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672 post injections 1 and 4~hours 0 (pre-dose) 1, 2, 4, 6, 8, 12, 20, 24, 25, 26, 28, 30, 32, 36, 44, 48, 144, 192, 240, 312, 384, 456, 528, 600, 672, 846, 1008, 1200, 1344 post injection 6"|Day -1, Days 1-29, 85-113, 141-197|The PK analysis population was defined as any subject in Groups 1 – 6 who received a dose of RBP-6000 or at least 1 dose of SUBUTEX SL tablet and had an adequate number of PK samples collected to derive PK parameters.|||% of average concentration||Standard Deviation|Mean
2642218|NCT01738503|Primary|Participants With Treatment-Emergent Adverse Events (TEAEs)|TEAE=any untoward medical occurrence that develops or worsens in severity after dispensation of the study drug and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= a marked limitation in activity. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent one of the outcomes listed in this definition. A serious AE (SAE) is defined as any AE occurring at any dose that results in any of the following outcomes: death; lifethreatening AE; hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacit|Days -14 to -1 (Subutex treatment), Days 1-316 (RBP-6000 treatment)|Safety analysis group|||Participants|||Count of Participants
2642219|NCT01738477|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to 31 days post-vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented.|||Participants|||Count of Participants
2642220|NCT01738477|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.|During the 31 days (Day 0 - 30) after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented.|||Participants|||Count of Participants
2642221|NCT01738477|Secondary|Number of Subjects With Solicited General Symptoms.|The solicited local symptoms assessed were Fatigue, Gastrointestinal, Headache and Fever. Any = any solicited general symptom regardless of intensity.|During the 4 days (Day 0 - 3) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented and the symptom sheet filled-in.|||Participants|||Count of Participants
2642222|NCT01738477|Secondary|Number of Subjects With Solicited Local Symptoms.|The solicited local symptoms assessed were Pain, Redness and Swelling. Any = any solicited local symptom regardless of intensity.|During the 4 days (Day 0 - 3) follow-up period after vaccination.|The analysis was performed on the Total Vaccinated cohort, which included all subjects with a study vaccine administration dose documented and the symptom sheet filled-in.|||Participants|||Count of Participants
2642223|NCT01738477|Secondary|Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN.|"Booster response to pertussis antigens was defined as:~for initially seronegative subjects (pre-booster antibody concentration below the assay cut-off) with an increase of at least four times the assay cut-off one month after vaccination;~for initially seropositive subjects with anti-body concentration < four times the assay cut-off with an increase of at least four times the pre-booster antibody concentration one month after vaccination;~for initially seropositive subjects with anti-body concentration ≥ four times the assay cut-off with an increase of at least two times the pre-booster antibody concentration one month after vaccination."|At Month 1.|The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.|||Participants|||Count of Participants
2642224|NCT01738477|Secondary|Number of Subjects With a Booster Response to Anti-D and Anti-T.|"Booster response to anti-D and anti-T antigens was defined as:~for initially seronegative subjects with pre-booster antibody concentration below 0.1 IU/mL, an increase of at least four times 0.1 IU/mL one month after vaccination,~for initially seropositive subjects with pre-booster antibody concentration ≥ 0.1 IU/mL, an increase of at least four times the pre-booster antibody concentration one month after vaccination."|At Month 1|The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.|||Participants|||Count of Participants
2642225|NCT01738477|Secondary|Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN).|Concentrations were expressed in geometric mean concentrations (GMCs).|At Month 0|The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.|||IU/mL||95% Confidence Interval|Geometric Mean
2642226|NCT01738477|Secondary|Anti-D and Anti-T Antibody Concentrations.|Concentrations were expressed as GMCs.|At Month 0 and Month 1|The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.|||IU/mL||95% Confidence Interval|Geometric Mean
2642227|NCT01738477|Secondary|Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off.|The cut-off of the assay was ≥ 1.0 IU/mL.|At Month 0 and Month 1|The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.|||Participants|||Count of Participants
2642228|NCT01738477|Secondary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).|A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)|At Month 0|The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.|||Participants|||Count of Participants
2642229|NCT01738477|Primary|Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Against Filamentous Hemagglutinin (Anti-FHA) and Against Pertactin (Anti-PRN).|Concentrations were expressed in geometric mean concentrations (GMCs).|At Month 1|The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.|||IU/mL||95% Confidence Interval|Geometric Mean
2642230|NCT01738477|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).|A seroprotected subject was defined as a subject with anti-D/anti-T antibody concentrations above or equal (≥) to 0.1 IU/mL (international units per milliliter)|At Month 1|The analysis was done on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who had met the eligibility criteria, who complied with the procedures and intervals defined in the protocol and for whom assay results were available for antibodies against at least one study vaccine antigen.|||Participants|||Count of Participants
2642231|NCT01738438|Post-Hoc|15-Week Clinical Benefit Rate|The 15-week clinical benefit rate (CBR) was defined as absence of disease progression (PD) per RECIST1.1 criteria at the second disease assessment (week 15). Radiographic PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning therapy, the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Confirmatory scans for response were required 3 weeks following initial documentation.|Disease was evaluated radiologically at baseline, week 6 and week 15 on treatment.|The analysis dataset is comprised of all treated patients.|||proportion of participants||95% Confidence Interval|Number
2642232|NCT01738438|Secondary|Progression Free Survival|Progression-free survival (PFS) estimated using Kaplan-Meier methods was defined as the time from registration to documented disease progression (PD) or death. Based on RECIST1.1, radiographic PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning therapy, the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Patients who were event-free were censored at the date of their last disease evaluation.|Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
2642233|NCT01738438|Primary|Objective Response Rate|The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) on treatment based on RECIST1.1 criteria. For target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Confirmatory scans were required 3 weeks following initial documentation.|Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).|The analysis dataset is comprised of all treated patients.|||proportion of participants||95% Confidence Interval|Number
2642234|NCT01738321|Primary|Change in Intracuff Pressure||1 day||||cmH2O||Standard Deviation|Mean
2642235|NCT01738191|Secondary|Change in WAIS-IV: Digit Span|"Wechsler Adult Intelligence Scale, fourth edition Digit Span | Scaled | age| 1-16~Higher scores mean a better outcome."|change from baseline and 10 weeks|Intent-to-treat sample of all patients randomized.|||units on a scale||Standard Deviation|Mean
2642236|NCT01738191|Secondary|Change in D-KEFS: Number-Letter Switching Time|"Delis-Kaplan Executive Function System Trail Making Number/Letter Switching | Scaled | age normed| range 1-16 Higher scores mean a better outcome."|change from baseline and 10 weeks|Intent-to-treat sample of all patients randomized.|||units on a scale||Standard Deviation|Mean
2642237|NCT01738191|Secondary|Change in D-KEFS: Inhibition-Switching Time|"Delis-Kaplan Executive Function System Color-Word Inhibition/Switching | Scaled | age normed| range 1-16 Higher scores mean a better outcome."|change from baseline and 10 weeks|Intent-to-treat sample of all patients randomized.|||units on a scale||Standard Deviation|Mean
2642238|NCT01738191|Secondary|Change in D-KEFS: Inhibition Time|"Delis-Kaplan Executive Function System Color-Word Inhibition Time | Scaled | age normed| range 1-16 Higher scores mean a better outcome."|change from baseline and 10 weeks|Intent-to-treat sample of all patients randomized.|||units on a scale||Standard Deviation|Mean
2642239|NCT01738191|Secondary|Change in NAB: Part D|"Neuropsychological Assessment Battery Numbers & Letters D Efficiency | T-score| age & education normed| range 19-70~Higher scores mean a better outcome."|change from baseline and 10 weeks|Intent-to-treat sample of all patients randomized.|||units on a scale||Standard Deviation|Mean
2642240|NCT01738191|Secondary|Change in NAB: Part A|"Neuropsychological Assessment Battery Numbers & Letters A Efficiency | T-score| age & education normed| range 19-70~Higher scores mean a better outcome."|change from baseline and 10 weeks|Intent-to-treat sample of all patients randomized.|||units on a scale||Standard Deviation|Mean
2642241|NCT01738191|Secondary|Change in PASAT|"Paced Auditory Serial Addition Test 3-second interstimulus interval | Z-score| age & education normed| range -5 to +5 Higher scores mean a better outcome."|change from baseline and 10 weeks|Intent-to-treat sample of all patients randomized.|||units on a scale||Standard Deviation|Mean
2642242|NCT01738191|Primary|The Global Statistical Test Combined Information on Change From Baseline on a Battery of Standardized Executive Function Tests|Patients were ranked on each outcome and ranks were summed. The mean summed-ranks were compared by treatment group by a global statistical test (GST). Higher scores indicate better performance. The total summed-ranks range from 7 - 210 (7 outcomes x N=30).|change from baseline and 10 weeks|Intent-to-treat sample of all patients randomized.|||summed-ranks||95% Confidence Interval|Mean
2642243|NCT01737996|Primary|Cmax and Cmax,ss of Faldaprevir (Combined Treatment Part)|Maximum measured concentration of Faldaprevir on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12, 24 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2642244|NCT01737996|Primary|AUC(0-24h) and AUC(0-24h,ss) of Faldaprevir (Combined Treatment Part)|Area under the concentration-time curve of Faldaprevir over the uniform dosing interval 0 to 24 h on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2642245|NCT01737996|Primary|C(12h) and C(12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)|"Concentration of CD 6168 acylglucuronide at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.~CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2642246|NCT01737996|Primary|Cmax and Cmax,ss of CD 6168 Acylglucuronide (Combined Treatment Part)|"Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 16.~CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2642277|NCT01737840|Secondary|Need for Additional Drug|The investigators are measuring the need for additional drug at the end of 60 minutes.|60 th minute||||participants|||Number
2642247|NCT01737996|Primary|AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Combined Treatment Part)|"Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.~CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2642248|NCT01737996|Primary|C(12h) and C(12h,ss) of BI 208333 (Combined Treatment Part)|"Concentration of BI 208333 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.~BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2642249|NCT01737996|Primary|Cmax and Cmax,ss of BI 208333 (Combined Treatment Part)|"Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 16.~BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2642250|NCT01737996|Primary|AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Combined Treatment Part)|"Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.~BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2642251|NCT01737996|Primary|C(12h) and C(12h,ss) of CD 6168 (Combined Treatment Part)|"Concentration of CD 6168 at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.~CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2642252|NCT01737996|Primary|Cmax and Cmax,ss of CD 6168 (Combined Treatment Part)|"Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 16.~CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2642253|NCT01737996|Secondary|Cmax and Cmax,ss of CD 6168 Acylglucuronide (Multiple Rising Dose Part)|"Maximum measured concentration of CD 6168 acylglucuronide on Day 1 and at steady state on Day 9.~CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2642254|NCT01737996|Secondary|AUC(0-12h) and AUC(0-12h,ss) of CD 6168 Acylglucuronide (Multiple Rising Dose Part)|"Area under the concentration-time curve of CD 6168 acylglucuronide over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.~CD 6168 acylglucuronide is a metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2642255|NCT01737996|Secondary|Cmax and Cmax,ss of BI 208333 (Multiple Rising Dose Part)|"Maximum measured concentration of BI 208333 on Day 1 and at steady state on Day 9.~BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2642256|NCT01737996|Secondary|AUC(0-12h) and AUC(0-12h,ss) of BI 208333 (Multiple Rising Dose Part)|"Area under the concentration-time curve of BI 208333 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.~BI 208333 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2642257|NCT01737996|Secondary|Cmax and Cmax,ss of CD 6168 (Multiple Rising Dose Part)|"Maximum measured concentration of CD 6168 on Day 1 and at steady state on Day 9.~CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2642258|NCT01737996|Secondary|AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Multiple Rising Dose Part)|"Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.~CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2642259|NCT01737996|Secondary|Cmax and Cmax,ss of Deleobuvir (Multiple Rising Dose Part)|Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 9.|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2643467|NCT01728324|Secondary|Prognostic Value of SVR12 Predicting SVR24|The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed.|24 Week (post-treatment)|FAS|||Percentage of participants|||Number
2642260|NCT01737996|Primary|AUC(0-12h) and AUC(0-12h,ss) of CD 6168 (Combined Treatment Part)|"Area under the concentration-time curve of CD 6168 over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.~CD 6168 is a major metabolite of Deleobuvir."|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2642261|NCT01737996|Primary|C(12h) and C(12h,ss) of Deleobuvir (Combined Treatment Part)|Concentration of Deleobuvir at the end of the dosing interval 0 to 12 h on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2642262|NCT01737996|Primary|Cmax and Cmax,ss of Deleobuvir (Combined Treatment Part)|Maximum measured concentration of Deleobuvir on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2642263|NCT01737996|Primary|AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Combined Treatment Part)|Area under the concentration-time curve (AUC) of Deleobuvir over the uniform dosing interval 0 to 12 h (hours) on Day 1 and at steady state on Day 16.|After the first administration of Deleobuvir+Faldaprevir on Day 1 and after the last administration on Day 16 at 0 (5 min before administration on Day 16), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 hours (h) after drug administration in the morning.|PKS. The pharmacokinetic set (PKS) included all subjects of the treated set who provided at least 1 observation for at least 1 pharmacokinetic endpoint without important protocol violations relevant for the statistical evaluation of pharmacokinetic endpoints. Including patients with available data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2642264|NCT01737996|Primary|Number of Healthy Subjects With AEs (Multiple Rising Dose Part)|Number of healthy subjects with any adverse event (AE) during the on-treatment period.|From first drug administration (Day 1) until end of trial examination (15 to 21 days after first administration)|Treated Set. The treated set included all subjects who were documented to have taken at least 1 dose of study medication.|||participants|||Number
2642265|NCT01737996|Secondary|AUC(0-12h) and AUC(0-12h,ss) of Deleobuvir (Multiple Rising Dose Part)|Area under the concentration-time curve of Deleobuvir over the uniform dosing interval 0 to 12 h on Day 1 and at steady state on Day 9.|After the first administration of Deleobuvir on Day 1 and after the last administration on Day 9: at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8,12 h after drug administration in the morning.|PKS including patients with available data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2642266|NCT01737944|Primary|Bioequivalence Based Upon Dose-Normalized Cmax for MTX|Dose-normalized maximum observed concentration for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.|||ng/mL/mg||Standard Deviation|Mean
2642267|NCT01737944|Primary|Bioequivalence Based Upon Dose-Normalized AUC[0-24] for MTX|Dose-normalized area under the curve from time zero to 24 hours post-dose (AUC[0-24]/Dose) for each treatment|24 Hour period|Dose-normalized MTX PK parameter AUC(0-24)/Dose used for comparison|||ng*hr/mL/mg||Standard Deviation|Mean
2642268|NCT01737944|Primary|Bioequivalence Based Upon Dose-Normalized AUC[0-Inf] for MTX|Dose-normalized area under the curve from time zero to infinity (AUC[0-inf]/Dose) for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.|||ng*hr/mL/mg||Standard Deviation|Mean
2642269|NCT01737931|Secondary|Itching of Application Site Evaluated by VAS After Patch Removal|"Changes of itching of application site evaluated by VAS after patch removal (acceleration and dose-escalation periods).~The score ranges from 0 (no itching) to 100 (strongest imaginable itching)."|Up to 96 hours after patch removal|FAS|||Scores on a scale||Standard Deviation|Mean
2642270|NCT01737931|Secondary|Skin Irritation Score After Patch Removal|Numbers of subjects with each skin irritation score. The scale scoring criteria are 0(-): Negative, 0.5(±): Faint erythema, 1(+): Erythema, 2(++): Erythema + edema, 3(+++): Erythema + edema + papules, serous papule, vesicles, 4(++++): Coalescing vesicles.|Up to 72 hours after patch removal|FAS subjects with a score of ≥ 0.5 (±) at Day 3|||Percentage of participants|||Number
2642271|NCT01737931|Primary|Itching of Application Site Evaluated by the Visual Analogue Scale (VAS)|"Itching of application site evaluated by the visual analogue scale (VAS) 24 hours after 2 mg/24 hour patch removal (dose-escalation period) and difference between Steroid or Antihistamine and No-treatment.~The score ranges from 0 (no itching) to 100 (strongest imaginable itching)."|24 hours after 2 mg/24 hr patch removal|FAS|||Scores on a scale||95% Confidence Interval|Mean
2642272|NCT01737931|Primary|Skin Irritation Score of the Application Site|"Skin irritation score of the application site 24 hours after 2 mg/24 hour patch removal (dose-escalation period) and difference between Steroid or Antihistamine and No-treatment.~The scale scoring criteria are 0(-): Negative, 0.5(±): Faint erythema, 1(+): Erythema, 2(++): Erythema + edema, 3(+++): Erythema + edema + papules, serous papule, vesicles, 4(++++): Coalescing vesicles."|24 hours after 2 mg/24 hr patch removal|Full analysis set (FAS) subjects with a score of ≥ 0.5 (±) at Day 3|||Scores on a scale||95% Confidence Interval|Mean
2642273|NCT01737879|Secondary|Peginesatide Dose by Visit||Baseline and Weeks 5, 9, 13, and 17|Primary analysis set, with available data at each time point (indicated by n)|||mg||Standard Deviation|Mean
2642274|NCT01737879|Secondary|Hemoglobin Concentration by Visit||Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21|"Primary analysis set includes all enrolled participants who received at least 1 dose of investigational product. The number of participants with available data at each time point is indicated by n."|||g/dL||Standard Deviation|Mean
2642275|NCT01737879|Secondary|Mean Dose of Epoetin Alfa During the Evaluation Period|No participant reached the evaluation period, therefore, this endpoint could not be evaluated.|Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).|||||||
2642278|NCT01737840|Primary|Visual Analogue Scale Score|The investigators are measuring the change of pain from the baseline to the 30th and 60th minutes by visual anologue scale (VAS). Visual Analogue Scale measurement is between 0 (no pain) and 100 (worst pain). A decrease of 13 or 16 mm in VAS score is accepted as a minimum clinically significant change in pain.|30th and 60th minutes||||Visual Analogue Scale||Standard Deviation|Mean
2642279|NCT01737762|Secondary|Time in Days to Closure|Compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure, based on time in days to closure over the 16-week treatment period from baseline.|16 Weeks||||Days||Standard Deviation|Mean
2642280|NCT01737762|Primary|Wound Closure|Compare HP802-247 plus compression therapy against Vehicle plus compression therapy for proportion of subjects with complete wound closure over the 16-week treatment period from baseline.|16 Weeks||||participants|||Number
2642281|NCT01737710|Secondary|Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H3N2|The difference in the percentage of moderate to severe AD participants that achieved seroconversion at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone (Intramuscular) vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H3N2 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
2642282|NCT01737710|Secondary|Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H1N1|The difference in the percentage of moderate to severe AD participants that achieved seroconversion at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone (Intramuscular) vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H1N1 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
2642283|NCT01737710|Secondary|Seroconversion, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza B|The difference in the percentage of moderate to severe AD participants that achieved seroconversion at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone (Intramuscular) vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza B compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
2642284|NCT01737710|Secondary|Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2|The difference in the percentage of participants that achieved seroconversion at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H3N2 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
2642296|NCT01737697|Secondary|Mean Percent Change From Subacute Baseline in Serum Potassium at All Time Points.|Mean percent change from subacute baseline in serum potassium at all time points during subacute phase|Through 18 days of subacute phase (12 days treatment, 6 days follow-up)|ITT population. One subject (087-025) in the ZS 5 g TID/5 g QD group died on Study Day 4 and was excluded from the ITT Population|||percentage||Standard Deviation|Mean
2642297|NCT01737697|Secondary|Mean Change From Subacute Baseline in Serum Potassium at All Time Points.|Mean change from subacute baseline in serum potassium at all time points during subacute phase|Through 18 days of subacute phase (12 days treatment, 6 days follow-up)|ITT population. One subject (087-025) in the ZS 5 g TID/5 g QD group died on Study Day 4 and was excluded from the ITT Population|||mmol/L||Standard Deviation|Mean
2644558|NCT01717742|Secondary|Duration of Fever After Intervention|Duration of fever (defined as temperature >38 degrees celsius taken by any method) from insertion of the chest drain until resolution.|up to 4 months||||days||Standard Deviation|Mean
2642285|NCT01737710|Secondary|Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe AD, Intradermal - Influenza H1N1|The difference in the percentage of participants that achieved seroconversion at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza H1N1 compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
2642286|NCT01737710|Secondary|Seroconversion, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B|The difference in the percentage of participants that achieved seroconversion at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine. Seroconversion is defined as a 4-fold or greater increase in serum hemagglutination-inhibition [HAI] antibody titers against influenza B compared to baseline values, which represents the minimum intended effect of vaccination. Participants who achieved seroprotection, defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B, prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroconversion at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
2642287|NCT01737710|Secondary|Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H3N2|The difference in the percentage of moderate to severe AD participants that achieved seroprotection against influenza H3N2 at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone (Intramuscular) vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
2642288|NCT01737710|Secondary|Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza H1N1|The difference in the percentage of moderate to severe AD participants that achieved seroprotection against influenza H1N1 at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone (Intramuscular) vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
2642289|NCT01737710|Secondary|Seroprotection, Moderate to Severe Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intramuscular - Influenza B|The difference in the percentage of moderate to severe AD participants that achieved seroprotection against influenza B at Day 28 between those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine and those given a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone (Intramuscular) vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
2642298|NCT01737697|Secondary|Percentage of Subjects Within Each Treatment Group Who Retained Normal S-K Values at End of Subacute Phase|Percentage of subjects within each treatment group who retained normal S-K values (values between 3.5-5.0 mmol/L) at end of subacute phase|Through 18 days of subacute phase (12 days treatment, 6 days follow-up)|ITT population. One subject (087-025) in the ZS 5 g TID/5 g QD group died on Study Day 4 and was excluded from the ITT Population|||percentage of participants|||Number
2642299|NCT01737697|Secondary|Time Subjects Remain Normokalemic (Subacute Phase)|Time (number of days) subjects remain normokalemic (3.5 - 5.0 mmol/l) subacute phase|Through 18 days (12 days treatment, 6 days follow-up) of subacute phase|ITT population. One subject (087-025) in the ZS 5 g TID/5 g QD group died on Study Day 4 and was excluded from the ITT Population|||Days||Standard Deviation|Mean
2644559|NCT01717742|Secondary|Time to Drain Removal|Time from drain insertion to drain removal.|up to 4 months||||days||Standard Deviation|Mean
2642290|NCT01737710|Secondary|Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2|The fold-difference (defined as a ratio to describe the change from baseline to Day 28) in geometric mean serum HAI antibody titers against influenza H3N2 between non-AD and moderate to severe AD participants, following a single dose of the seasonal 2012-2013 Fluzone Intradermal vaccine. A fold-difference of greater than or equal to 1 indicated an increase in HAI antibody titers against influenza H3N2 as a result of vaccination; therefore, higher numbers indicate a greater probability of avoiding disease if infected with influenza H3N2 Participants who achieved seroprotection prior to vaccination were excluded from the analysis, which is defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||HAI antibody titers||95% Confidence Interval|Geometric Mean
2642291|NCT01737710|Secondary|Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H1N1|The fold-difference (defined as a ratio to describe the change from baseline to Day 28) in geometric mean serum HAI antibody titers against influenza H1N1 between non-AD and moderate to severe AD participants, following a single dose of the seasonal 2012-2013 Fluzone Intradermal vaccine. A fold-difference of greater than or equal to 1 indicated an increase in HAI antibody titers against influenza H1N1 as a result of vaccination; therefore, higher numbers indicate a greater probability of avoiding disease if infected with influenza H1N1. Participants who achieved seroprotection prior to vaccination were excluded from the analysis, which is defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations|||HAI antibody titers||95% Confidence Interval|Geometric Mean
2642292|NCT01737710|Secondary|Fold-difference in Geometric Mean Serum Hemagglutination-inhibition (HAI) Antibody Titers, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B|The fold-difference (defined as a ratio to describe the change from baseline to Day 28) in geometric mean serum HAI antibody titers against influenza B between non-AD and moderate to severe AD participants, following a single dose of the seasonal 2012-2013 Fluzone Intradermal vaccine. A fold-difference of greater than 1 indicated an increase in HAI antibody titers against influenza B as a result of vaccination; therefore, higher numbers indicate a greater probability of avoiding disease if infected with influenza B. Participants who achieved seroprotection (which is defined as having a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B) prior to vaccination were excluded from the analysis.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||HAI antibody titers||95% Confidence Interval|Geometric Mean
2642293|NCT01737710|Primary|Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H3N2|The difference in the percentage of participants that achieved seroprotection against influenza H3N2 at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H3N2. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H3N2 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
2642294|NCT01737710|Primary|Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza H1N1|The difference in the percentage of participants that achieved seroprotection against influenza H1N1 at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza H1N1. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percentage of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 Post Vaccination|Subset of the per protocol population that were not seroprotected against influenza H1N1 at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations.|||percentage of participants|||Number
2642295|NCT01737710|Primary|Seroprotection, Non-Atopic Dermatitis (AD), Intradermal vs. Moderate to Severe Atopic Dermatitis, Intradermal - Influenza B|The difference in the percent of participants that achieved seroprotection against influenza B at Day 28 between non-AD and moderate to severe AD participants, following a single dose (0.1mL) of the seasonal 2012 - 2013 Fluzone Intradermal vaccine. Seroprotection is defined as having a serum hemagglutination-inhibition (HAI) antibody titer of 1:40 or greater, which represents a sufficient antibody amount to avoid disease in half of the individuals infected with influenza B. Participants who achieved seroprotection prior to vaccination were excluded from the analysis. The goal was to examine whether there was a difference between the two groups in the percent of participants who achieved seroprotection at Day 28 who were not seroprotected prior to vaccination.|Day 28 post vaccination|Subset of the per protocol population that were not seroprotected against influenza B at baseline. These participants received a full dose of vaccine, provided blood samples on Day 0 and Day 28, and had no major protocol deviations|||percentage of participants|||Number
2644598|NCT01717521|Primary|Mean ANI Changes 3 Min After Ketamine Bolus|ANI was measured pre- and post- i.v. ketamine administration|Before vs 3 min after Ketamine adminstration||||index||Standard Deviation|Mean
2642300|NCT01737697|Secondary|Mean Percent Change From Baseline in S-K Change at All Time Points Acute Phase|Mean percent change from baseline in S-K at all time points over initial 48 hours|Through 48 hours acute phase. In particular, 1, 2, 4 hour Post 1st Dose on Study Day 1; 0 hour Pre-dose, 1, 4 hour Post 1st Dose on Study Day 2; and 0 hour Pre-dose on Study Day 3.|ITT population|||percentage||Standard Deviation|Mean
2642301|NCT01737697|Secondary|Mean Change From Baseline in S-K at All Time Points Acute Phase|Mean change from baseline in S-K at all time points over initial 48 hours|Through 48 hours acute phase. In particular, at Baseline; 1, 2, 4 hour Post 1st Dose on Study Day 1; 0 hour Pre-dose, 1, 4 hour Post 1st Dose on Study Day 2; and 0 hour Pre-dose on Study Day 3.|ITT population|||mmol/L||Standard Deviation|Mean
2642302|NCT01737697|Secondary|Percentage of Subjects Who Achieve Normalization in S-K Levels After 48 Hours of Treatment||Through 48 hours acute phase|Subjects from ITT population who have completed Acute phase|||percentage of participants|||Number
2642303|NCT01737697|Primary|Exponential Rate of Change in S-K Levels in the Subacute Phase.||Through 12 days subacute phase (Day 3 through Day 15)|ITT population. One subject in the ZS 5 g TID/5 g QD group died on Study Day 4 and was excluded from the ITT Population|||log(mmol/L)/hour||Standard Error|Mean
2642304|NCT01737697|Primary|Exponential Rate of Change in Serum Potassium (S-K) Levels During the Initial 48 Hours of Study Drug Treatment.||Through 48 hours acute phase|ITT Population|||log(mmol/L)/hour||Standard Error|Mean
2642305|NCT01737684|Secondary|Apparent Terminal Half-life (t½) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||hr||Geometric Coefficient of Variation|Geometric Mean
2642306|NCT01737684|Secondary|Time to Maximum Observed Plasma Drug Concentration (Tmax) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||hr||Full Range|Median
2642307|NCT01737684|Secondary|Maximum Observed Plasma Drug Concentration (Cmax) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||nM||95% Confidence Interval|Geometric Mean
2642308|NCT01737684|Secondary|Apparent Volume of Distribution During the Terminal Phase (Vd/F) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||L||Geometric Coefficient of Variation|Geometric Mean
2642309|NCT01737684|Secondary|Apparent Clearance (CL/F), Calculated as Dose/AUC0-∞, After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|Per Protocol (PP) population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2642310|NCT01737684|Primary|Area Under the Concentration Time Curve From 0 to Infinity (AUC0-∞) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected for determination of vibegron levels predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|Per Protocol (PP) population, which included the subset of participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||uM•hr||95% Confidence Interval|Geometric Mean
2642311|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|Prior to discharge, up to 3 hours after induction.||||units on a scale||Standard Deviation|Mean
2642312|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|45 minutes post-emergence|Participants not yet discharged at the 45 minute time point|||units on a scale||Standard Deviation|Mean
2642313|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|30 minutes post-emergence|Participants not yet discharged at the 30 minute time point|||units on a scale||Standard Deviation|Mean
2642569|NCT01736241|Secondary|Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102|AUC curve from time 0 to 168 hours postdose of LY3053102.|Time 0 to 168 hours after study drug administration on Day 1|Participants who received at least one dose of LY3053102 and with evaluable LY3053102 concentration data.|||microgram*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
2642314|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|15 minutes post-emergence|Participants not yet discharged at the 15 minute time point|||units on a scale||Standard Deviation|Mean
2642315|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|5 minutes post-emergence||||units on a scale||Standard Deviation|Mean
2642316|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|Emergence (spontaneous extremity movement)||||units on a scale||Standard Deviation|Mean
2642317|NCT01737593|Secondary|Postanesthesia Pain Score|Children's Hospital of Eastern Ontario pain scale (CHEOPS) is an observational scale for measuring postoperative pain in young children. The scale includes six categories of pain behavior: (Cry, facial, verbal, torso, touch, and legs). A score ranging from 0 to 2 or 1 to 3 is assigned to each activity and the summed score ranges between 4 and 13, with a higher score meaning more pain.|Induction||||units on a scale||Standard Deviation|Mean
2642318|NCT01737593|Primary|Postanesthesia Emergence Agitation (EA) Score|"EA was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale. This scale measures if the: 1. Child makes eye contact with the caregiver, 2. Child's actions are purposeful, 3. Child is aware of his/her surroundings, 4. Child is restless, 5. Child is inconsolable.~Items 1, 2, and 3 are reversed scored as follows: 4 _ not at all, 3 _ just a little, 2 _ quite a bit, 1 _ very much, 0 _ extremely. Items 4 and 5 are scored as follows: 0 _ not at all, 1 _ just a little, 2 _ quite a bit, 3 _ very much, 4_extremely. Scores of each item are summed to obtain a total PAED scale score, range 0-20, with higher PAED scores indicating a greater degree of emergence delirium.~The average PAED score of all the time points is use"|Induction,Emergence(spontaneous extremity movement),and every 5 min after emergence until the patient is discharged. This is an average of 3 hours till discharge.||||units on a scale||Standard Deviation|Mean
2642319|NCT01737398|Secondary|Inotersen Plasma Clearance At Steady State (CLss/F) At Week 65||Week 65|The PK Set was defined as all randomized participants who received at least 1 dose of active study drug (inotersen) and had at least 1 evaluable PK sample collected and analyzed with a reportable result.|||L/hr||Standard Deviation|Mean
2642320|NCT01737398|Secondary|Plasma Clearance From 0 To 24 Hours (CL[0-24hr]/F) Of Inotersen At Week 65||Week 65|The PK Set was defined as all randomized participants who received at least 1 dose of active study drug (inotersen) and had at least 1 evaluable PK sample collected and analyzed with a reportable result.|||L/hr||Standard Deviation|Mean
2642321|NCT01737398|Secondary|Area Under The Plasma Concentration-time Curve From 0 To 168 Hours (AUC[0-168hr]) Of Inotersen At Week 65||Week 65|The PK Set was defined as all randomized participants who received at least 1 dose of active study drug (inotersen) and had at least 1 evaluable PK sample collected and analyzed with a reportable result.|||ug*hr/mL||Standard Deviation|Mean
2642322|NCT01737398|Secondary|Area Under The Plasma Concentration-time Curve From 0 To 24 Hours (AUC[0-24hr]) Of Inotersen At Week 65||Week 65|The PK Set was defined as all randomized participants who received at least 1 dose of active study drug (inotersen) and had at least 1 evaluable PK sample collected and analyzed with a reportable result.|||ug*hr/mL||Standard Deviation|Mean
2642323|NCT01737398|Secondary|Time To The Maximum Plasma Concentration (Tmax) Of Inotersen At Week 65||Week 65|The PK Set was defined as all randomized participants who received at least 1 dose of active study drug (inotersen) and had at least 1 evaluable PK sample collected and analyzed with a reportable result.|||hours||Standard Deviation|Mean
2642324|NCT01737398|Secondary|Maximum Measured Plasma Concentration (Cmax) Of Inotersen At Week 65||Week 65|The PK Set was defined as all randomized participants who received at least 1 dose of active study drug (inotersen) and had at least 1 evaluable PK sample collected and analyzed with a reportable result.|||ug/mL||Standard Deviation|Mean
2642325|NCT01737398|Secondary|Change From Baseline in Retinol Binding Protein 4 (RBP4) Level at Week 65||Baseline and Week 65|The full analysis set included all randomized participants who received at least 1 injection of study drug (inotersen or placebo) and who had a Baseline and at least 1 post-Baseline efficacy assessment for the mNIS+7 score or Norfolk QoL-DN questionnaire total score. Participants analyzed = participants with evaluable data.|||ug/L||Standard Deviation|Mean
2642326|NCT01737398|Secondary|Change From Baseline in Transthyretin (TTR) Level at Week 65||Baseline and Week 65|The full analysis set included all randomized participants who received at least 1 injection of study drug (inotersen or placebo) and who had a Baseline and at least 1 post-Baseline efficacy assessment for the mNIS+7 score or Norfolk QoL-DN questionnaire total score. Participants analyzed = participants with evaluable data.|||g/L||Standard Deviation|Mean
2642327|NCT01737398|Secondary|Change From Baseline in Global Longitudinal Strain (GLS) by Echocardiogram ECHO at Week 65 in the ECHO Subgroup|GLS by ECHO is a measure of cardiac systolic function|Baseline and Week 65|The full analysis set included all randomized participants who received at least 1 injection of study drug (inotersen or placebo) and who had a Baseline and at least 1 post-Baseline efficacy assessment for the mNIS+7 score or Norfolk QoL-DN questionnaire total score. Participants analyzed = participants with evaluable data.|||Percent Change||Standard Deviation|Mean
2642328|NCT01737398|Secondary|Change From Baseline in Global Longitudinal Strain (GLS) by Echocardiogram (ECHO) at Week 65 in the CM-ECHO Set|GLS by ECHO is a measure of cardiac systolic function|Baseline and Week 65|The CM-ECHO Set includes the subset of the Randomized Set who had a diagnosis of TTR cardiomyopathy at study entry but are not in the ECHO subgroup, plus participants who qualified to participate in the ECHO subgroup (whether consented or not). Participants analyzed = participants with evaluable data.|||Percent Change||Standard Deviation|Mean
2642329|NCT01737398|Secondary|Change From Baseline in NIS+7 at Week 66|The NIS+7 score is a version of the NIS score that is a measure of neurologic impairment. The NIS+7 Score has a range of -26.04 to 270.04 and a higher NIS score indicates lower function.|Baseline and Week 66|The full analysis set included all randomized participants who received at least 1 injection of study drug (inotersen or placebo) and who had a Baseline and at least 1 post-Baseline efficacy assessment for the mNIS+7 score or Norfolk QoL-DN questionnaire total score. Participants analyzed = participants with evaluable data.|||Scores on a Scale||Standard Deviation|Mean
2642330|NCT01737398|Secondary|Change From Baseline in Modified +7 at Week 66|The Modified +7 score is a version of the NIS score that is a measure of neurologic impairment. The Modified +7 Score has a range of -22.32 to 102.32 and a higher NIS score indicates lower function.|Baseline and Week 66|The full analysis set included all randomized participants who received at least 1 injection of study drug (inotersen or placebo) and who had a Baseline and at least 1 post-Baseline efficacy assessment for the mNIS+7 score or Norfolk QoL-DN questionnaire total score. Participants analyzed = participants with evaluable data.|||Scores on a Scale||Standard Deviation|Mean
2642331|NCT01737398|Secondary|Change From Baseline in Neuropathy Impairment Score (NIS) at Week 66|The NIS score is a measure of neurologic impairment. The NIS Score has a range of 0 to 244 and a higher NIS score indicates lower function.|Baseline and Week 66|The full analysis set included all randomized participants who received at least 1 injection of study drug (inotersen or placebo) and who had a Baseline and at least 1 post-Baseline efficacy assessment for the mNIS+7 score or Norfolk QoL-DN questionnaire total score. Participants analyzed = participants with evaluable data.|||Scores on a Scale||Standard Deviation|Mean
2642332|NCT01737398|Secondary|Change From Baseline In Body Mass Index (BMI) at Week 65||Baseline and Week 65|The full analysis set included all randomized participants who received at least 1 injection of study drug (inotersen or placebo) and who had a Baseline and at least 1 post-Baseline efficacy assessment for the mNIS+7 score or Norfolk QoL-DN questionnaire total score. Participants analyzed = participants with evaluable data.|||kg/m^2||Standard Deviation|Mean
2642333|NCT01737398|Secondary|Change From Baseline In Modified Body Mass Index (mBMI) at Week 65|The mBMI is the BMI multiplied by the serum albumin g/L|Baseline and Week 65|The full analysis set included all randomized participants who received at least 1 injection of study drug (inotersen or placebo) and who had a Baseline and at least 1 post-Baseline efficacy assessment for the mNIS+7 score or Norfolk QoL-DN questionnaire total score. Participants analyzed = participants with evaluable data.|||kg/m^2*g/L||Standard Deviation|Mean
2642334|NCT01737398|Secondary|Change From Baseline In The Norfolk QoL-DN Questionnaire Physical Functioning/Large Fiber Neuropathy Domain Score at Week 66|The Norfolk QoL-DN physical functioning/large fiber neuropathy domain score is a sub-score of the total Norfolk QoL-DN Questionnaire. The Norfolk QoL-DN physical function/large fiber neuropathy domain score has a range of -4 to 56, and a higher Norfolk QoL-DN domain score indicates poorer QoL.|Baseline and Week 66|This endpoints only measured participants who had Stage 2 hATTR-PN in Full Analysis Set. Participants analyzed = participants with evaluable data.|||Scores on a Scale||Standard Deviation|Mean
2642335|NCT01737398|Secondary|Change From Baseline In The Norfolk QoL-DN Questionnaire Symptoms Domain Score at Week 66|The Norfolk QoL-DN symptoms score is a sub-score of the total Norfolk QoL-DN Questionnaire. The Norfolk QoL-DN symptoms domain score has a range of 0-32, and a higher Norfolk QoL-DN score indicates poorer QoL.|Baseline and Week 66|This endpoint only measured participants with Stage 1 hATTR-PN in Full Analysis Set. Participants analyzed = participants with evaluable data.|||Scores on a Scale||Standard Deviation|Mean
2642336|NCT01737398|Primary|Change From Baseline In The Norfolk Quality Of Life Diabetic Neuropathy (QoL-DN) Questionnaire at Week 66|The Norfolk QoL-DN score is a measure of physical function/large fiber neuropathy, symptoms, activities of daily living, small fiber neuropathy, and autonomic neuropathy. The Norfolk QoL-DN total score has a range of -4 to 136, and a higher Norfolk QoL-DN score indicates poorer QoL.|Baseline and Week 66|The full analysis set included all randomized participants who received at least 1 injection of study drug (inotersen or placebo) and who had a Baseline and at least 1 post-Baseline efficacy assessment for the mNIS+7 score or Norfolk QoL-DN questionnaire total score. Participants analyzed = participants with evaluable data.|||Scores on a Scale||Standard Deviation|Mean
2642337|NCT01737398|Primary|Change From Baseline In The Modified Neuropathy Impairment Score (mNIS) +7 Composite Score at Week 66|The mNIS+7 composite score is a measure of neurologic impairment that evaluates muscle weakness, sensation, reflexes, nerve conduction, and autonomic function. The mNIS+7 Composite Score has a range of -22.32 to 346.32 and a higher mNIS+7 composite score indicates lower function.|Baseline and Week 66|The full analysis set included all randomized participants who received at least 1 injection of study drug (inotersen or placebo) and who had a Baseline and at least 1 post-Baseline efficacy assessment for the mNIS+7 score or Norfolk QoL-DN questionnaire total score. Participants analyzed = participants with evaluable data.|||Scores on a Scale||Standard Deviation|Mean
2642338|NCT01737281|Secondary|Number of Participants Self-Reporting 7-Day Abstinence From Cigarettes|At 12 month follow-up, participants were asked if the had smoked any cigarettes in the last 7 days|12 months|"We used a complete case analysis, excluding participants for whom information was not available at 12 month follow-up"|||Participants|||Count of Participants
2642339|NCT01737281|Primary|Number of Participants With Cotinine-Validated Abstinence From Smoking|The primary outcome will be cotinine-validated abstinence from smoking at 12-month follow-up.|12 months|"Cotinine samples were obtained by mail from 53/76 people reporting abstinence in the intervention arm and 44/58 people reporting abstinence in the control arm. Note that this reflects a complete case analysis, only including people for whom outcome data are available."|||Participants|||Count of Participants
2642340|NCT01737268|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, re quire d or prolonged hospitalization or was considered medically important.|From first dose of study drug up to week 52 (52 weeks)|Safely Analysis Set (SAF), which included participants who received at least one dose of study drug.|||Participants|||Count of Participants
2658566|NCT01597388|Primary|Post-Baseline Glucose Elevation||28 Days|The analysis population consisted of all participants who received at least one dose of AZD2014.|||Participants|||Number
2642341|NCT01737268|Secondary|CGI-BP-C: Mania|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.|||units on a scale||Standard Deviation|Mean
2642342|NCT01737268|Secondary|CGI-BP-C: Depression|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.|||units on a scale||Standard Deviation|Mean
2642343|NCT01737268|Secondary|Clinical Global Impression-Bipolar-Change (CGI-BP-C): Overall Bipolar Illness|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.|||units on a scale||Standard Deviation|Mean
2642344|NCT01737268|Secondary|Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Mania|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill).|Baseline and and week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.|||units on a scale||Standard Deviation|Mean
2642345|NCT01737268|Secondary|Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Depression|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill).|Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.|||units on a scale||Standard Deviation|Mean
2642346|NCT01737268|Secondary|Change From Baseline to Last Assessment in Treatment Period in Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill).|Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.|||units on a scale||Standard Deviation|Mean
2642347|NCT01737268|Secondary|Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17)|The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52 with lower scores indicating less depressive symptoms.|Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.|||units on a scale||Standard Deviation|Mean
2642348|NCT01737268|Primary|Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.|Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)|FAS population; last assessment value is used for participants who discontinued before week 52.|||units on a scale||Standard Deviation|Mean
2642349|NCT01737021|Secondary|Hospital Anxiety and Depression Scale (HADS)|Validated measure of anxiety and depression in the parent.|3-6 months post discharge from PICU|||||||
2642350|NCT01737021|Secondary|Impact of Events Scale (IES)|Validated measure of post-traumatic stress symptoms in the parent.|3-6 months post discharge from PICU|||||||
2642351|NCT01737021|Primary|The Number of Feasibility Criteria Successfully Met|"Feasibility success criteria have been defined a priori for the intervention and study design. There are six feasibility criteria related to the intervention, covering aspects of the timing of the intervention, compliance, and evaluation. There are also six feasibility criteria related to the study design, covering recruitment rate; participation rate; acceptability of procedures; attrition rate; and the time-scale of data collection.~Dependent on the number of criteria successfully met, the following classification will be used:~0-2/6 criteria met - Stop; intervention and/or study design not feasible.~3-4/6 criteria met - Continue with modifications; feasible intervention and/or study design with modifications.~5/6 criteria met - Continue without modifications, but monitor closely; feasible intervention and/or study design with close monitoring.~6/6 criteria met - Continue without modifications; feasible intervention and/or study design as is."|3-6 months post discharge from PICU||||Number of criteria successfully met|||Number
2642352|NCT01736930|Primary|Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 3|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL.|21 days||||number of mornings|Participants||Number
2642461|NCT01736566|Secondary|Expectations|"Novel survey items asked participants about whether or not their genetic test results would be useful for specific reasons. Response options were no, probably not, probably yes, and yes. Responses of probably yes and yes were combined to simplify presentation of data."|Baseline|Randomized participants who completed the baseline survey.|||Participants|||Count of Participants
2642353|NCT01736930|Primary|Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 2|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL.|21 days||||number of mornings|Participants||Number
2642354|NCT01736930|Primary|Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 1|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL.|21 days||||number of mornings|Participants||Number
2642355|NCT01736930|Primary|Mornings With Blood Ketones >0.6 mmol/L - Algorithm 3|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L.|21 days||||number of mornings|Participants||Number
2642356|NCT01736930|Primary|Mornings With Blood Ketones >0.6 mmol/L - Algorithm 2|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L.|21 days||||number of mornings|Participants||Number
2642357|NCT01736930|Primary|Mornings With Blood Ketones >0.6 mmol/L - Algorithm 1|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L.|21 days||||number of mornings|Participants||Number
2642358|NCT01736930|Primary|Percent Morning Blood Glucose >250 mg/dL - Algorithm 3|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as overall percentage of mornings glucose measured with home glucose meter >250 mg/dL.|21 days||||percentage of mornings|Participants||Number
2642359|NCT01736930|Primary|Percent Morning Blood Glucose >250 mg/dL - Algorithm 2|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as overall percentage of mornings glucose measured with home glucose meter >250 mg/dL.|21 days||||percentage of mornings|Participants||Number
2642360|NCT01736930|Secondary|Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 3||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use||||percentage of sensor glucose values|Participants|Inter-Quartile Range|Median
2642361|NCT01736930|Secondary|Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 2||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use||||percentage of sensor glucose values|Participants|Inter-Quartile Range|Median
2642362|NCT01736930|Secondary|Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 1||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use||||percentage of sensor glucose values|Participants|Inter-Quartile Range|Median
2642363|NCT01736930|Secondary|Mean Sensor Glucose Overnight - Algorithm 3||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use||||mg/dl|Participants|Standard Deviation|Mean
2642364|NCT01736930|Secondary|Mean Sensor Glucose Overnight - Algorithm 2||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use||||mg/dl|Participants|Standard Deviation|Mean
2642365|NCT01736930|Secondary|Mean Sensor Glucose Overnight - Algorithm 1||Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use||||mg/dl|Participants|Standard Deviation|Mean
2642366|NCT01736930|Primary|Percent Morning Blood Glucose >250 mg/dL - Algorithm 1|The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as the overall percentage of mornings glucose measured with home glucose meter >250 mg/dL.|21 days||||percentage of mornings|Participants||Number
2642367|NCT01736930|Primary|Mean Morning Blood Glucose (mg/dL)- Algorithm 3|"The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL).~The hypoglycemia prediction horizon was reduced further in algorithm 3 to 30 minutes. A total of 114 study nights (37 Control nights and 77 Intervention nights) using algorithm 3."|21 study nights||||mg/dl|Participants|Standard Deviation|Mean
2642368|NCT01736930|Primary|Mean Morning Blood Glucose (mg/dL)- Algorithm 2|"The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL).~Algorithm 1 was modified to reduce the hypoglycemia prediction horizon from 70 minutes to 50 minutes, to suspend the pump only when the continuous glucose monitor sensor glucose value was ≤ 230 mg/dl, not suspend if there was a drop of >40 mg/dl in consecutive sensor glucose readings, and to resume insulin delivery at the first rise in sensor glucose following a suspension. There was 156 nights of study data collected (48 Control nights and 108 Intervention nights) using algorithm 2."|21 study nights||||mg/dl|Participants|Standard Deviation|Mean
2642369|NCT01736930|Primary|Mean Morning Blood Glucose (mg/dL)- Algorithm 1|"The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL).~An objective was to evaluate and refine the control algorithm. The data were reviewed periodically during the study with the pre-stated goal of determining whether any changes should be made in the control algorithm. Algorithm 1 was used for the first 105 nights of the study (38 Control nights and 67 Intervention nights). The horizon prediction time of algorithm 1 was set at 70 minutes."|21 study nights||||mg/dl|Participants|Standard Deviation|Mean
2645021|NCT01714323|Secondary|Continuous Tobacco Abstinence|Continuous tobacco abstinence after hospital discharge assessed by self-report at 1, 3, and 6 months.|1 month, 3 months, 6 months||||Participants|||Count of Participants
2642370|NCT01736917|Secondary|Self-Reported Assessment of Nausea|"the patient's self-reported assessment of nausea Days 1-8 using a 0-100mm visual analog scale (VAS) median.~The Visual Analouge (VAS) 100mm Scale Score for Chemotherapy Induced Nausea and Vomiting (CINV). Participants were asked to mark a linear scale 100mm in length representing their level of nausea with 0mm indicating no nausea and 100mm indicating severe nausea. Median VAS scores (in mm) are reported, per day."|Days 1-8 of chemotherapy regimen|54 patients completed the VAS on all 8 days and were eligible for analysis.|||millimeters||Full Range|Median
2642371|NCT01736917|Secondary|Use of Rescue Medications.|Total number of patients who received rescue medications.|Days 1-8 of chemotherapy regimen||||participants|||Number
2642372|NCT01736917|Secondary|Total Number of Emetic Episodes|total number of emetic episodes|Days 1-8 of chemotherapy regimen||||episodes|||Number
2642373|NCT01736917|Primary|Percentage of Participants With Complete Response of Acute and Delayed Chemotherapy Induced Nausea and Vomiting|complete response (CR) of both acute (days 1 through 5) and delayed (days 6 through 8) CINV, defined by no emetic episodes or use of rescue medications|Days 1-8 of chemotherapy regimen||||percentage of participants|||Number
2642374|NCT01736865|Other Pre-specified|Effect of Vitamin D Supplementation on Plasma Concentrations of Surrogate Biomarkers of Cholesterol Absorption (Campesterol and β-sitosterol) and Endogenous Synthesis (Lathosterol and Desmosterol)||6 months|||||||
2642375|NCT01736865|Other Pre-specified|Cardiovascular Risk Factors|Cardiovascular risk factors defined as blood pressure, lipid profile, C-reactive protein and urine albumin excretion|6 and 12 months|||||||
2642376|NCT01736865|Other Pre-specified|Effect of Vitamin D Supplementation on Blood 25-hydroxyvitaminD Concentration||12 months||||ng/mL||Standard Deviation|Mean
2642377|NCT01736865|Other Pre-specified|Variability of Response to Vitamin D Supplementation in Subgroups.|Variability of response to vitamin D supplementation in subgroups defined by baseline characteristics: (1) race; (3) 25OHD concentration; (3) diabetes treatment.|Baseline and 12 months|||||||
2642378|NCT01736865|Other Pre-specified|Change in Diabetes Medications||6 and 12 months|||||||
2642379|NCT01736865|Other Pre-specified|Hemoglobin A1c||12 months||||percentage||Standard Error|Mean
2642380|NCT01736865|Secondary|Number of Participants With Change in Glycemia|Change in glycemia (categorical variable, composite outcome) defined as [1] a decrease in diabetes medications or [2] a reduction of equal to or more than 0.4 HbA1c units from baseline without increasing medications.|12 months||||Participants|||Count of Participants
2642381|NCT01736865|Primary|Disposition Index|Disposition index by the insulin secretion sensitivity index-2 (ISSI-2). This is an calculated value which represents the ability of a person's pancreatic beta cells to lower blood glucose. A higher number means the pancreas is better able to secrete insulin and improve glucose levels.|6 months||||index||Standard Error|Mean
2642382|NCT01736696|Secondary|Gene Expression in Peripheral Blood|Punch biopsy and serum blood were assayed for messenger Ribonucleic acid (mRNA) gene expression by quantitative PCR using standard curve(SC) method generated by linear regression using log threshold cycle versus log(cell number). granzyme B, IFN-gamma, TNF-alpha (FasL and superfamily member 5 [SF5]), BCL2, BAX, iNOS, and CD 25 presented as control gene normalized expression(relative expression) within SC. The Relative mRNA Gene Expression Level is relative to baseline and normalized to the housekeeping gene 18 Svedberg unit ribosomal RNA (18S rRNA).|Day 14|Analysis population:all participants who met eligibility criteria. 'N'(number of participants analyzed)=participants evaluable for this measure. ‘n =participants evaluable for specified category for each arm group respectively. Gene expression results were planned to be analyzed for participants who received CP-690,550 5,30 mg and matching placebo.|||relative expression unit (REU)||Standard Deviation|Mean
2642383|NCT01736696|Secondary|Number of Participants With Intracellular Adhesion Molecule (ICAM-1) by Epidermal Keratinocytes Expression|Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against ICAM-1. Number of participants with ICAM-1 expression was to be assessed qualitatively using epidermal keratinocytes.|Baseline (within 7 days prior to Day 1) up to Day 14|Analysis of ICAM-1 in biopsy specimens was not performed as it often continues to be expressed on vessels in the skin even when psoriasis was resolved, thus would not provide a measure of response to therapy.||||||
2642384|NCT01736696|Secondary|Number of Participants With Keratin 16 (K16) Expression|Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against K16. Number of participants with K16 expression were assessed qualitatively using suprabasal keratinocytes.|Baseline (within 7 days prior to Day 1) up to Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2642385|NCT01736696|Secondary|Immunohistochemistry From Psoriatic Plaque Biopsies|Immunohistochemical staining of skin biopsies was performed with monoclonal antibodies directed against cluster of differentiation 3 (CD3) and cluster of differentiation 8 (CD8) T-lymphocytes, cluster of differentiation 16/56 (CD16/56) natural killer cells, and cluster of differentiation 83 (CD83) mature dendritic cells. Baseline was defined as mean of samples obtained at the screening visit within 7 days prior to Day 1, at the baseline biopsy, and Day 0. Immunohistochemistry results were planned to be analyzed for participants who received CP-690,550 5, 20, 30 mg and matching placebo.|Baseline (within 7 days prior to Day 1), Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’ = participants evaluable for this measure at specified time points for each arm group respectively.|||cells/microliter (cells/μL)||Standard Deviation|Mean
2642399|NCT01736696|Primary|Change From Baseline in Immune Cell Function at Day 14|The degree of immunosuppression induced by the study drug administration was evaluated using a bioluminescent assay in which the concentration of Adenosine-5-Triphosphate (ATP) released by CD4 cells was measured. ATP concentrations released from stimulated and unstimulated cells were evaluated. ATP Concentration less than or equal to (<=) 225: low immune cell response, 226 to 524: Moderate immune cell response, >= 525: strong immune cell response. Baseline was defined as the mean of the samples collected during the pre-dose biopsy.|Baseline (Within 7 days prior to Day 1), Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure. ‘n’ = participants evaluable for this measure at specified time points for each arm group respectively.|||ng/mL||Standard Deviation|Mean
2642386|NCT01736696|Secondary|Gene Expression in Psoriatic Plaque Biopsies|Gene expression by quantitative polymerized chain reaction (PCR) using standard curve (SC) method generated by linear regression using log threshold cycle versus log(cell number). Keratin (K)-16, inducible nitric oxide synthase (iNOS), Interleukin 8 (IL-8), CD25, Granzyme B, IL-2, IL-7, IL-15, Interferon-gamma (INF-gamma), C-X-C motif chemokine(CXCL10), perforin 1, B-cell Lymphoma 2 (BCL-2), BCL2 associated X Protein (BAX), Tumor Necrosis Factor Fas Ligand (TNF-FasL), and proliferating cell nuclear antigen (PCNA) presented as control gene normalized expression (relative expression) within SC.|Day 14|Analysis population:all participants who met eligibility criteria. 'N'(number of participants analyzed)=participants evaluable for this measure. ‘n =participants evaluable for specified category for each arm group respectively. Gene expression results were planned to be analyzed for participants who received CP-690,550 5,30 mg and matching placebo.|||relative expression unit (REU)||Standard Deviation|Mean
2642387|NCT01736696|Secondary|Number of Participants With Physician's Global Assessment (PGA) of Psoriasis|Physician global assessment (PGA) of Psoriasis is a 7-point scale used to assess severity of psoriatic plaques, scaling and/or erythema. Severity scale ranged from 1 to 7: 1=severe, 2=moderate to severe, 3=moderate, 4=mild to moderate, 5=mild, 6=almost clear, 7=clear (no sign of psoriasis).|Baseline (Within 7 days prior to Day 1) up to Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||participants|||Number
2642388|NCT01736696|Secondary|Number of Participants With Modified Psoriasis Severity Index (mPASI) at Day 14|Modified Psoriasis Area and Severity Index (mPASI) assessed lesion severity but not the body surface area affected. Severity was estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final mPASI = sum of the each component scores. Total score range 0-12 , higher score indicated more severity.|Baseline (Within 7 days prior to Day 1) up to Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||participants|||Number
2642389|NCT01736696|Primary|Half Maximal Effective Area Under the Concentration-Time Curve 50 (EAUC 50)|EAUC 50 was calculated from a regression analyses using area under the concentration-time curve (AUC) as the independent variable. A sigmoid maximum effect (Emax) model was used to explain the relationship between AUC and modified Psoriasis Severity Index (mPASI) score, where Emax was the maximum effect (100 percent reduction in the total mPASI score from baseline), and EAUC 50 was the AUC where 50 percent of the maximum effect was measured.|Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL|||Number
2642390|NCT01736696|Primary|Time to Reach Maximum Change From Baseline and Time to Return to Baseline Value for Fluorescence-Activated Cell Sorting (FACS), Reticulocyte Counts and Immune Cell Function||Day 0 (pre-dose), 1, 2, 4, 7, 10, 14, 15, 18, 21, 28, 42|Data was not analyzed as per planned analyses due to pattern of changes observed.||||||
2642391|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 42|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 42|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||1000 cells/mm^3||Standard Deviation|Mean
2642392|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 28|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 28|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||1000 cells/mm^3||Standard Deviation|Mean
2642393|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 21|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 21|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||1000 cells/mm^3||Standard Deviation|Mean
2642394|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 15|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 15|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||1000 cells/mm^3||Standard Deviation|Mean
2642395|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 10|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 10|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||1000 cells/mm^3||Standard Deviation|Mean
2642396|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 7|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 7|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||1000 cells/mm^3||Standard Deviation|Mean
2642397|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 4|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 4|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||1000 cells/mm^3||Standard Deviation|Mean
2642398|NCT01736696|Primary|Change From Baseline in Reticulocyte Count at Day 2|Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.|Baseline (Within 7 days prior to Day 1), Day 2|Analysis population included all participants who met the eligibility criteria. ‘n’ = participants evaluable for this measure at specified time points for each arm group respectively.|||1000 cells/cubic millimeter (cells/mm^3)||Standard Deviation|Mean
2644600|NCT01717482|Secondary|Number of Participants With Adverse Events as a Measure of Safety|To compare participant adverse events between metformin and observation arms using CTCAE version 4.|4 years|Study terminated due to poor accrual and funding ended||||||
2642400|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 42|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||percent change||Standard Deviation|Mean
2642401|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 28|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||percent change||Standard Deviation|Mean
2642402|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 21|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||percent change||Standard Deviation|Mean
2642403|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, Hour 0 on Day 18|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||percent change||Standard Deviation|Mean
2642404|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline; hr 0, 8 hr post-dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||percent change||Standard Deviation|Mean
2642405|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 10|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||percent change||Standard Deviation|Mean
2642406|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 7|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||percent change||Standard Deviation|Mean
2642407|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 4|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||percent change||Standard Deviation|Mean
2658567|NCT01597388|Primary|QTcF Over 24 Hours||24 hours|The analysis population consisted of all participants who received at least one dose of AZD2014.|||msec||Standard Deviation|Mean
2642408|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, hr 0 on Day 2|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed)=participants evaluable for this measure.|||percent change||Standard Deviation|Mean
2642409|NCT01736696|Primary|Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1|Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.|Baseline, 1 hr post-dose on Day 1|Analysis population included all participants who met the eligibility criteria.|||percent change||Standard Deviation|Mean
2642410|NCT01736696|Primary|Accumulation Ratio (R0)|Accumulation ratio was calculated as, R0 = area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1 and Day 14|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||Ratio||Standard Deviation|Mean
2642411|NCT01736696|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 14||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||hr||Full Range|Median
2642412|NCT01736696|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 1||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||hr||Full Range|Median
2642413|NCT01736696|Primary|Maximum Observed Plasma Concentration (Cmax) at Day 14||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Mean
2642414|NCT01736696|Primary|Maximum Observed Plasma Concentration (Cmax) at Day 1||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2642415|NCT01736696|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 14|AUCtau = area under the curve from time zero to end of dosing interval.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||Standard Deviation|Mean
2642416|NCT01736696|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 1|AUCtau = area under the curve from time zero to end of dosing interval.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1|Pharmacokinetic analysis population included all participants who met the eligibility criteria and had 1 post-baseline pharmacokinetic assessment. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
2642417|NCT01736696|Primary|Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum QTc >=500 msec were reported.|1, 2, 4, 8, 12 hrs post dose, additional 16 hrs post dose for 60 mg once daily group on Day 1; 1, 2 hrs post dose on Day 4, 7, 10;1,2,4,8,12 hrs post dose on Day 14; Day 21|Analysis population included all participants who met the eligibility criteria.|||participants|||Number
2642418|NCT01736696|Primary|Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of 30 to less than (<) 60 msec(borderline) and greater than or equal to (>=) 60 msec (prolonged) were summarized.|1, 2, 4, 8, 12 hrs post dose, additional 16 hrs post dose for 60 mg once daily group on Day 1; 1, 2 hrs post dose on Day 4, 7, 10;1,2,4,8,12 hrs post dose on Day 14; Day 21|Analysis population included all participants who met the eligibility criteria.|||participants|||Number
2642511|NCT01736540|Secondary|Mean Serum Ferritin According to the Presence or Absence of Retrospective Hepatic Events|Mean serum ferritin according to the presence or absence of hepatic events was assessed for all participant subgroups.|12 months - retrospective|Participants with serum ferritin values and previous hepatic events data were included in the analysis.|||ng/mL||Standard Deviation|Mean
2642419|NCT01736696|Primary|Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|12 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||msec||Standard Deviation|Mean
2642420|NCT01736696|Primary|Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||msec||Standard Deviation|Mean
2642421|NCT01736696|Primary|Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||msec||Standard Deviation|Mean
2642422|NCT01736696|Primary|Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria.'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||msec||Standard Deviation|Mean
2642423|NCT01736696|Primary|Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|23 hrs prior to morning dose on Day 1 (Baseline for HPD 1), 1 hr post morning dose on Day 14|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||msec||Standard Deviation|Mean
2642424|NCT01736696|Primary|Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. The mean of the triplicates at HPD=0 on Day 1 will be defined as the baseline for HPD=0.|Hour 0 (pre-dose) on Day 1 (Baseline for HPD 0), 0 hr on Day 14|Analysis population included all participants who met the eligibility criteria.|||msec||Standard Deviation|Mean
2642425|NCT01736696|Primary|Change From Baseline in QT Interval at 16 Hour Post Morning Dose (HPD 16) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.Change from baseline in QT interval at HPD 16 was planned to be analyzed for participants who received CP-690,550 60 mg and matching placebo.|8 hrs prior to morning dose on Day 1 (Baseline for HPD 16), 16 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||msec||Standard Deviation|Mean
2642426|NCT01736696|Primary|Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|12 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.|||msec||Standard Deviation|Mean
2642427|NCT01736696|Primary|Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.|||msec||Standard Deviation|Mean
2642512|NCT01736540|Secondary|Mean Serum Ferritin According to the Presence or Absence of Retrospective Cardiac Events|Mean serum ferritin according to the presence or absence of cardiac events was assessed for all participant subgroups.|12 months - retrospective|Participants with serum ferritin values and previous cardiac events data were included in the analysis.|||ng/mL||Standard Deviation|Mean
2642428|NCT01736696|Primary|Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria. Here, the ‘n’ is signifying those participants who were evaluable for this measure at the specified time point for each arm group.|||msec||Standard Deviation|Mean
2642429|NCT01736696|Primary|Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1|Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled hour post morning dose (HPD), except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria.|||msec||Standard Deviation|Mean
2642430|NCT01736696|Primary|Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled hour post morning dose (HPD), except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.|23 hours (hrs) prior to morning dose on Day 1 (Baseline for HPD 1), 1 hour (hr) post morning dose on Day 1|Analysis population included all participants who met the eligibility criteria.|||millisecond (msec)||Standard Deviation|Mean
2642431|NCT01736683|Secondary|Number of Participants Who Achieved Red Blood Cell (RBC)-Transfusion Independence During the Erythroid Hematological Improvement (HI-E) Interval|Number of participants who achieved RBC-independence was defined as participants who required no RBC-transfusions during a 56-day interval of erythroid hematological improvement (HI-E). NTDE = non-transfusion dependence efficacy participants who required < 4 units of RBCs in the 8 weeks prior to start of therapy TDE = transfusion dependence efficacy participants who required >=4 units of RBCs in the 8 weeks prior to start of therapy|Day 2 to Day 142|Efficacy Evaluable Population|||Participants|||Count of Participants
2642432|NCT01736683|Secondary|Dose Limiting Toxicities (DLTs)|The following were DLTs if the investigator suspected they were treatment related: 1. Increase to >= 140 mmHg systolic blood pressure 2. Increase to >=90 mmHg diastolic blood pressure 3. Increase to >=140 systolic and increase > 20 mmHg compared to baseline systolic 4. Increase to >=90 mmHg diastolic and increase > 20 mmHg compared to baseline diastolic 5. Introduction of new anti-hypertension medication during treatment 6. Increase in dose of baseline anti-hypertension medication during treatment 7. >= Grade 2 (moderate severity or worse) hypertension as an adverse event|Day 1 to 59.2 months|Safety population|||Participants|||Count of Participants
2642433|NCT01736683|Secondary|Participants With Treatment-Emergent Adverse Events (TEAE)|An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 42 days after the last dose. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0 and the scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death. Relation to study drug was determined by the investigator. A treatment-related TEAE is defined as TEAE which was considered to be related to the study drug and reported as 'Suspected' on the CRF. AEs with a missing relationship were treated as 'treatment-related' in data summaries.|Day 1 up to 59.2 months|Safety population: all participants who receive at least one dose of study medication.|||Participants|||Count of Participants
2642434|NCT01736683|Secondary|Pharmacokinetic Parameters of Sotatercept: Serum Concentration at Various Study Timepoints|Maximum observed serum concentration, obtained directly from the observed concentration versus time data.|Cycle 1 Day 8 and !5 up to Cycle 2 Day 1|Pharmacokinetic (PK) population includes participants with a sufficient amount of post-dose quantifiable PK sotatercept profile.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2642435|NCT01736683|Secondary|Kaplan-Meier Estimates for Overall Survival (OS)|OS was defined as the time between start of treatment and the death/censored date. Participants who died (regardless of the cause of death) were considered to have an event. Participants who were alive at the end of the study, and participants who were lost to follow-up, were censored at the last date when subjects were known to be alive.|Day 1 to 257.3 weeks|Efficacy Evaluable Population|||weeks||95% Confidence Interval|Median
2642436|NCT01736683|Secondary|Kaplan-Meier Estimates for Progression-free Survival|Participants who had disease progression were considered to have events. Participants who died without acute myeloid leukemia (AML) were also considered to have events with the event date as the date of death. Those who did not have disease progression and who were lost to follow-up were censored at the last known disease progression assessment date. Participants without disease progression at the last follow-up contact were censored at the date of the last follow-up contact date. Disease Progression to AML used criteria by the International Working Group (IWG) Response Criteria in Myelodysplasia (Cheson, 2006). Progression is considered if any of the following are met: - >=50% increase in blasts - >=50% decrement from maximum remission/response levels in granulocytes or platelets - Reduction in hemoglobin (Hgb) concentration by >=2 g/dL - Transfusion dependence|Day 1 to 257.3 weeks|Efficacy Evaluable Population|||weeks||95% Confidence Interval|Median
2642446|NCT01736579|Secondary|Volumetric MRI|Volumetric MRI measurements were obtained to assess rate of whole brain atrophy and ventricular enlargement. Additional volumetric measurements may be analyzed when specific hypotheses and methods are defined. Additional volumetric MRI analysis may include (but may not be limited to) one or more of the following: rate of hippocampal atrophy, entorhinal cortical thickness, and/or regional cortical thinning.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
2642437|NCT01736683|Secondary|Time to Progression to Events of Higher Risk Myelodysplastic Syndromes (MDS) Using the International Prognostic Scoring System (IPSS) For Participants Who Had Progression|Progression to events of higher risk MDS used criteria from the International Prognostic Scoring System for MDS (IPSS) which assigns a prognostic score (0=good and increasing in risk by half-grades with the top score outlined below) for three prognostic variables: - Marrow blasts (score 0-2.0) - Karyotype (score 0-1.0) - Cytopenias: neutrophil, platelets, and Hg counts (score 0-0.5) The three individual scores are summed resulting in a full range of 0- 3.5 and placed into risk categories 0 = low risk 0.5-1.0 = intermediate-1 risk 1.5-2.0 = intermediate-2 risk >=2.5 = high risk This outcome was defined as a Kaplan-Meier estimate however few participants progressed so a Kaplan-Meier analysis could not be performed. Data reported represent event times (weeks) for participants who did progress to higher risk MDS categories.|Day 1 to 257.3 weeks|Efficacy Evaluable Population of participants who progressed to high risk MDS categories|||weeks|||Number
2642438|NCT01736683|Secondary|Time to Progression to Acute Myeloid Leukemia (AML) for Participants Who Had Progression|Progression to AML used criteria by the International Working Group (IWG) Response Criteria in Myelodysplasia (Cheson, 2006). Progression is considered if any of the following are met: - >=50% increase in blasts - >=50% decrement from maximum remission/response levels in granulocytes or platelets - Reduction in Hgb concentration by >=2 g/dL - Transfusion dependence This outcome was defined as a Kaplan-Meier estimate however few participants progressed so a Kaplan-Meier analysis could not be performed. Disclosed are time to progression values only for participants who did progress to AML.|Day 1 to 183.7 weeks|Efficacy Evaluable Population of participants who progressed to AML|||weeks|||Number
2642439|NCT01736683|Secondary|Duration of Erythroid Hematological Improvement (HI-E)|The duration of HI-E response for participants who responded was (the last date of the consecutive hemoglobin [Hgb] measurements of the first >=56 day interval) - (the first date of the consecutive Hgb measurements of the first >=56 day interval) + 1 day.|Day 1 to 183.7 weeks|Efficacy Evaluable Population of participants who responded|||days||Full Range|Median
2642440|NCT01736683|Secondary|Time to Erythroid Hematological Improvement (HI-E) Response|Time to first response = start date of first response (HI-E) - first dose date + 1 day. For NTDE participants (who required < 4 units of RBCs in the 8 weeks prior to start of therapy), HI-E was defined as an increase of >=1.5 g/dL hemoglobin sustained for 56 days over a period of >=8 weeks. For TDE participants (who required >=4 units of RBCs in the 8 weeks prior to start of therapy), HI-E was defined as a decrease of >= 4 units of RBCs transfused sustained for 56 days over a period of 8 weeks.|Day 1 to Day 87|Efficacy Evaluable Population of participants who responded|||days||Full Range|Median
2642441|NCT01736683|Primary|Percentage of Participants With Erythroid Hematological Improvement (HI-E) Starting Before the Completion of Five Cycles of Treatment (Responder Rate)|The responder rate includes non-transfusion dependent efficacy (NTDE) participants and transfusion dependent efficacy (TDE) participants. For non-transfusion dependence efficacy (NTDE) participants who required < 4 units of RBCs in the 8 weeks prior to start of therapy, HI-E was defined as an increase of >=1.5 g/dL hemoglobin sustained for 56 days over a period of >=8 weeks. For transfusion dependence efficacy (TDE) participants who required >=4 units of RBCs in the 8 weeks prior to start of therapy, HI-E was defined as a decrease of >= 4 units of RBCs transfused sustained for 56 days over a period of 8 weeks.|Day 2 to Day 142|Efficacy Evaluable Population: all participants who take at least one dose of study medication and have baseline and at least one post-baseline assessment of efficacy without major deviation from protocol.|||percentage of participants|||Number
2642442|NCT01736657|Secondary|Device-related Serious Adverse Events (SAE) in the Full Analysis Set|Device-related serious adverse events (SAE) in the Full Analysis Set (72 patients).|upon signing consent to 24 hours post-procedure|Seventy-three enrolled: 12 were lead-in patients whereby Optia Operators completed their training and data from those procedures were not included in the efficacy analysis (60 patients), but these patients were included in safety analysis as Full Analysis Set; 1 patient was consented but withdrawn prior to procedure due to lack of vascular access.|||participants|||Number
2642443|NCT01736657|Secondary|Spectra Optia System's Ability to Achieve the Desired Final Hematocrit in the Evaluable Population|Measurement of the patient post-procedure hematocrit compared to the final target hematocrit calculated by the Spectra Optia Apheresis System. Final target hematocrit was calculated by tracking the number of red cells coming into the system versus the number of red cells removed.|Length of the procedure|60 patients analyzed, 73 enrolled:12 patients were lead-in patients whereby Optia Operators completed their training and data from those procedures were not included in the efficacy analysis (60 pts), but were included in the safety analysis (72 patients); 1 patient was consented but withdrawn prior to procedure due to lack of vascular access.|||ratio||95% Confidence Interval|Mean
2642444|NCT01736657|Secondary|Procedural Success of the Spectra Optia System in the Evaluable Population|The procedural success of the Spectra Optia System is defined as the ability of the device to complete a red blood cell exchange (RBCx) and to obtain a satisfactory exchange by lowering the patient's hemoglobin S, as determined by the investigator in the evaluable population (60 pts).|Length of the procedure|60 patients analyzed, 73 enrolled:12 patients were lead-in patients whereby Optia Operators completed their training and data from those procedures were not included in the efficacy analysis (60 pts), but were included in the safety analysis (72 patients); 1 patient was consented but withdrawn prior to procedure due to lack of vascular access.|||percentage of participants|||Number
2642445|NCT01736657|Primary|Mean Ratio Actual Fraction of Cells Remaining (FCRa; as Measured by Post-Procedure % HbS) to the Predicted Fraction of Cells Remaining (FCRp; as Predicted by the Spectra Optia System FCR Algorithm Multiplied by the Pre-Procedure % HbS)|The primary endpoint evaluated the mean ratio of the Actual Fraction of Cells Remaining (FCRa: as measured by Post-Procedure % HbS) to the Predicted Fraction of Cells Remaining (FCRp: as predicted by the Spectra Optia system FCR algorithm multiplied by the Pre-Procedure % HbS), in the evaluable population (60 pts). The pre-defined range for the mean ratio of the FCRa to the FCRp was 0.75 to 1.25.|Length of the procedure|60 patients analyzed, 73 enrolled:12 patients were lead-in patients whereby Optia Operators completed their training and data from those procedures were not included in the efficacy analysis (60 pts), but were included in the safety analysis (72 patients); 1 patient was consented but withdrawn prior to procedure due to lack of vascular access.|||ratio||95% Confidence Interval|Mean
2645022|NCT01714323|Primary|Tobacco Abstinence - 6 Month Follow-up|Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up|6 months||||Participants|||Count of Participants
2642447|NCT01736579|Secondary|Time to Skilled Nursing Facility Placement|Time to skilled nursing facility placement is defined as permanent admission to a skilled nursing facility. Time will be defined as the number of months between enrollment into this clinical study and placement in a skilled nursing facility placement.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
2642448|NCT01736579|Secondary|Caregiver Burden Questionnaire|The Caregiver burden questionnaires is a self-administered questionnaire that has been developed to measure the emotional, physical, and social impact of caregiving on Alzheimer's Disease caregivers. A Total score is calculated from this measure by summing the responses across the items. The Total score may range from 9-45, with higher scores indicating greater burden.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
2642449|NCT01736579|Secondary|Healthcare Resource Utilization Questionnaire (HRUQ)|The HRUQ determines if there is a difference in healthcare utilization and health-related expenditures, most notably nursing home (ie, skilled nursing facility) admissions, when subjects are treated with study product. This assessment is performed with the primary caregiver. This assessment is descriptive and does not contain specific scores.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
2642450|NCT01736579|Secondary|EQ-5D Questionnaire (Proxy Version)|"EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.~The EQ-5D also includes a standard vertical 20 cm visual analogue scale (VAS) ranging from best imaginable health state [100] to worst imaginable health state [0].~Caregivers are asked to describe how they believe a participant would rate his/her health state that day."|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
2642451|NCT01736579|Secondary|Logsdon Quality of Life in Alzheimer's Disease (QOL-AD)|The QOL-AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant's quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52. Lower scores on the QOL-AD are associated with a lower quality of life.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
2642452|NCT01736579|Secondary|Neuropsychiatric Inventory (NPI) Score|The NPI is a validated instrument used to assess behavioral psychopathology in Alzheimer's Disease; it evaluates the frequency and severity of 12 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
2642453|NCT01736579|Secondary|Mini Mental State Examination (MMSE)|The MMSE is a test for cognitive dysfunction. The test provides a 30-point composite rating for spatial and temporal orientation, verbal recall, simple attention, working memory, naming, repetition, comprehension, writing and constructional abilities. The total score can range from 0 to 30 with a higher score indicating better function.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
2642454|NCT01736579|Secondary|Alzheimer's Disease Cooperative Study (ADCS) - Activities of Daily Living (ADL) Inventory (ADCS-ADL/ ADCS-ADL-severe)|"The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner.~Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration."|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
2642455|NCT01736579|Secondary|Total Score of the Cognitive Subscale of the Severe Impairment Battery (SIB)|The SIB is a 40-item psychometric assessment that is composed of simple one-step commands combined with gestures. The scoring range is from 0 to 100 with a lower score indicating greater cognitive impairment.|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
2642456|NCT01736579|Secondary|Total Score of the Cognitive Subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog)|"The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at the site.~Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment."|6 months|This study was terminated early. Summary tables were not provided for this outcome measure due to the small number of participants (up to 2 participants per arm) because of concerns about patient confidentiality.||||||
2642457|NCT01736579|Primary|Number of Infusions Discontinued, Slowed or Interrupted Due to an Adverse Event (AE) or Serious Adverse Event (SAE)||6 months||||infusions|Infusions||Number
2642458|NCT01736579|Primary|Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)||6 months||||infusions|Infusions||Number
2642459|NCT01736579|Primary|Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)||6 months||||infusions|Infusions||Number
2642460|NCT01736579|Primary|Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)||6 months||||adverse events|||Number
2642462|NCT01736566|Secondary|Understanding|A novel item assessed participants' subjective understanding of their study results on a 1-5 scale, where higher scores indicate greater subjective understanding.|At post-disclosure visit (about 1 hour after results disclosure, avg. 11 mos. after baseline), at 6-weeks post-disclosure, and at 6-months post-disclosure (6 wks follow-up approx. 12.5 mos. and 6 mos. follow-up approx. 17 mos. after baseline)|Participants who answered the understanding item on the post-disclosure, 6-week follow-up, or 6-month follow-up surveys.|||units on a scale||Standard Deviation|Mean
2642463|NCT01736566|Secondary|Decisional Regret|Participants' satisfaction with their decision to participate in the MedSeq Project through a 5-item validated scale (Brehaut 2003). Average score computed after reversing scores of 2 negatively phrased items and converting score to range from 0-100 by subtracting 1 and multiplying by 25. Higher scores indicate greater regret.|At post-disclosure visit (about 1 hour after results disclosure, avg. 11 mos. after baseline), at 6-weeks post-disclosure, and at 6-months post-disclosure (6 wks follow-up approx. 12.5 mos. and 6 mos. follow-up approx. 17 mos. after baseline)|Participants who answered the decisional regret items on the post-disclosure, 6 week follow-up, or 6 month follow-up surveys|||units on a scale||Standard Deviation|Mean
2642464|NCT01736566|Secondary|Psychological Impact|Psychological impact was assessed by a modified version of the Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire. Higher scores indicated more distress related to study results.|6-weeks post-disclosure and 6-months post-disclosure (6wks. follow-up administered approx. 12.5 mos. and 6 mos. follow-up approx. 17 mos. after baseline)|Participants who answered the psychological impact items on the 6 week or 6 month follow-up questionnaires|||units on a scale||Standard Deviation|Mean
2642465|NCT01736566|Primary|Change in Perceived Utility|A novel survey item asked participants to rate the usefulness of whole genome sequencing results for managing health on a 1-10 scale. Scores at 6 months were compared to scores at baseline.|At baseline and 6-months post-disclosure (approx. 17 mos. after baseline)|Participants who received whole genome sequencing and completed the survey items at baseline and at 6 months|||units on a scale||Standard Deviation|Mean
2642466|NCT01736566|Primary|Changes in Health Care Utilization|Participants' health care utilization was assessed through a combination of medical record reviews and novel and adapted measures from the Behavioral Risk Factor Surveillance System (BRFSS). Changes are assessed by comparing the number of services and procedures received in 6 months following disclosure against the number of services and procedures received in the 6 months prior to disclosure.|6 months prior to disclosure and 6-months post-disclosure (approx. 17 mos. after baseline) and 5-years post-disclosure|All randomized participants who received disclosure|||units on a scale||Standard Deviation|Mean
2642467|NCT01736566|Primary|Changes in Genomic Literacy|Changes in participants' genomic literacy were measured with an 11-item measure adapted from the ClinSeq Study (Kaphingst K.A. et al. 2012) administered at baseline and 6 months post-disclosure. Items are marked as correct (1) or incorrect (0) and summed for a total scale range of 0 to 11, with higher scores indicating higher genomic literacy.|Assessing Genomic Literacy at baseline and 6-months post-disclosure (approx. 17 mos. after baseline)|Participants who completed the genetic literacy items in the baseline and 6-month follow-up surveys|||units on a scale||Standard Deviation|Mean
2642468|NCT01736566|Primary|Information Sharing|Sharing of information was assessed by asking patients if they intended to share results with others (at the end of the disclosure visit) and if they had shared their results with others (6 months after disclosure) adapted from the Health Information National Trends Survey (HINTS).|At the disclosure visit (about 1 hour after results disclosure, avg. 11 mos. after baseline) and 6-months post-disclosure (approx. 17 mos. after baseline)|Participants who answered information-sharing questions on the post-disclosure or 6-month follow-up questionnaire|||Participants|||Count of Participants
2642469|NCT01736566|Primary|Change in Health Behaviors|"Novel items that asked whether participants changed vitamin use, supplement use, medication use, diet, exercise, or other health behaviors. Counts and percentages represent participants who reported any health behavior changes."|6-weeks post-disclosure and 6-months post-disclosure (6 wks. follow-up administered approx. 12.5 mos. and 6 mos. follow-up approx. 17 mos. after baseline)|Participants who attended disclosure sessions and responded to post-disclosure surveys|||Participants|||Count of Participants
2642470|NCT01736566|Primary|Change in General Anxiety and Depression|The Hospital Anxiety and Depression Scale (HADS) scale was administered through a survey. This is a validated scale designed to assess the participants' level of depression and anxiety through Likert-type questions. Total ranges for each summed subscale, anxiety and depression, is 0-21. Any participant scoring >14 on the anxiety subscale or >16 on the depression subscale were contacted by study staff for evaluation. Higher scores indicate increased anxiety or depression from baseline to follow-up.|Baseline, at the disclosure visit (about 1 hour after results disclosure, avg. 11 mos. after baseline), 6-weeks post-disclosure and 6-months post-disclosure (6 wks. follow-up administered approx. 12.5 mos and 6 mos follow-up approx 17 mos. after baseline)|Participants who completed the baseline survey and follow-up surveys|||units on a scale||Standard Deviation|Mean
2642471|NCT01736566|Primary|Change in Intolerance of Uncertainty|Changes in participants' tolerance for uncertainty were assessed through a short 12-item version of the Intolerance of Uncertainty Scale (Carleton, 2007). Total summed scale range is 12-60, with higher scores indicating increased negative feelings about uncertainty from baseline to follow-up.|Baseline and 6-months post-disclosure (6 mos. follow-up administered approx. 17 mos. after baseline)|Participants who completed both the baseline and 6-month follow-up surveys|||units on a scale||Standard Deviation|Mean
2642472|NCT01736566|Primary|Change in Shared Decision Making|Changes in shared decision making were assessed through a single item adapted from the Control Preferences Scale, a measure designed to ascertain the degree of control an individual wants to assume when decisions are being made about medical treatment. Higher scores on a scale of 1-3 indicate preferences towards more equally shared decision making (Heisler et al 2003). Higher mean changes over time indicate a change in preference towards more equally shared decision making at follow-up.|Baseline and 6-weeks post-disclosure (6 wks follow-up administered approx. 12.5 mos. after baseline)|Participants who were completed the item on both the baseline and 6-week follow-up surveys|||units on a scale||Standard Deviation|Mean
2642570|NCT01736241|Primary|Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs|A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Day 31|Participants who received at least one dose of LY3053102 or placebo.|||participants|||Number
2642473|NCT01736566|Primary|Change in Perceived Health|A single-item measure assessed how participants perceived their own health on a 1-5 scale. Adapted from the SF-12 (DeSalvo KB, Qual Life Res, 2006). Higher scores indicate more positive perceptions of health at follow-up|Baseline, at the disclosure visit (about 1 hour after results disclosure, avg. 11 mos. after baseline) and 6-months post-disclosure (6 mos. follow-up follow-up administered approx. 17 months after baseline)|Participants who completed the item on patient surveys.|||units on a scale||Standard Deviation|Mean
2642474|NCT01736566|Primary|Change in Preferences for WGS Information|Through nine novel survey items, participants were asked about their preferences for the types of genetic testing results they would like to receive from their whole genome sequence. Scores on an 0-9 scale represent the change in the number of categories of types of genetic testing results out of 9 that participants wanted to learn about from Baseline to 6-weeks follow-up.|Baseline and 6-weeks post-disclosure (6 wks follow-up administered approx. 12.5 mos. after baseline)|Participants who completed both the baseline and 6-week follow-up surveys|||units on a scale||Standard Deviation|Mean
2642475|NCT01736566|Primary|Change in Self Efficacy|Assessed through a scale developed for the Multiplex Initiative (Kaphingst, K.A., et al. 2012). Higher scores on a 0-24 scale indicate greater confidence in participants' abilities to understand genetic information.|Baseline and 6-months post-results disclosure (6 mos. follow-up administered approx. 17 months after baseline)|Participants randomized to the experimental Family History + Whole Genome Sequencing arm who completed both the baseline and the 6-month follow-up surveys|||units on a scale||Standard Deviation|Mean
2642476|NCT01736566|Primary|Change in Attitudes and Trust|Adapted measures (Hall, MA, et al. 2006) assessed participants' attitudes toward genetic information, trust of their physicians and the medical system regarding interpretation and use of genetic information. Higher scores on a 12-60 scale represent more positive attitudes and greater trust.|Change at 6-weeks post-results disclosure relative to baseline, administered approx.12.5 months after baseline|Participants who completed the baseline survey and 6 week follow-up survey|||units on a scale||Standard Deviation|Mean
2642477|NCT01736553|Secondary|Correlation of Biomarkers (Weight) With Motor Function Tests for SMA Subjects SMN Copy Number =2 Cohort|Examine the correlation between each of the putative physiological and molecular biomarkers with the TIMPSI and CHOP-INTEND over the first two years of life in SMA (SMN = 2). All estimated correlations are the same at each study visit.|up to 24 months|The overall number of participants with SMA analyzed (14/14) differs from the total enrollment reported in the participant flow (26) because of the staggered enrollment, subset of subjects with SMA and significant mortality.|||kg/scores on a scale||95% Confidence Interval|Mean
2642478|NCT01736553|Secondary|Correlation of Protein Level Biomarkers With Motor Function Tests for SMA Subjects SMN Copy Number =2 Cohort|Examine the correlation between each of the putative physiological and molecular biomarkers with the TIMPSI and CHOP-INTEND over the first two years of life in SMA (SMN = 2). All estimated correlations are the same at each study visit.|up to 24 months|The overall number of participants with SMA analyzed (10/10) differs from the total enrollment reported in the participant flow (26) because of the staggered enrollment, insufficient sample, subset of subjects with SMA and significant mortality.|||(pg/10^7 PBMC0/scores on a scale||95% Confidence Interval|Mean
2642479|NCT01736553|Secondary|Correlation of mRNA Biomarkers With Motor Function Tests for SMA Subjects SMN Copy Number =2 Cohort|Examine the correlation between each of the putative physiological and molecular biomarkers with the TIMPSI and CHOP-INTEND over the first two years of life in SMA (SMN = 2). All estimated correlations are the same at each study visit.|up to 24 months|The overall number of participants with SMA analyzed (14 and 14) differs from the total enrollment reported in the participant flow (26) because of the staggered enrollment, subset of subjects with SMA and significant mortality.|||(SMN/HPRT)/scores on a scale||95% Confidence Interval|Mean
2642480|NCT01736553|Secondary|Correlation of CMAP Biomarker With Motor Function Tests for SMA Subjects SMN Copy Number =2 Cohort|Examine the correlation between each of the putative physiological and molecular biomarkers with the TIMPSI and CHOP-INTEND over the first two years of life in SMA (SMN = 2). All estimated correlations are the same at each study visit.|up to 24 months|The overall number of participants with SMA analyzed (14/14) differs from the total enrollment reported in the participant flow (26) because of the staggered enrollment, subset of subjects with SMA and significant mortality.|||mV/scores on a scale||95% Confidence Interval|Mean
2642481|NCT01736553|Secondary|Putative Physiological Biomarkers-Weight SMN Copy Number =2 Cohort|Describe and compare the distribution of motor function assessments over the first two years of life in SMA subjects with SMN copy number = 2 versus healthy control infants|Up to 24 months|The overall number of participants analyzed (14 and 26) differs from the total enrollment reported in the participant flow (26 and 27) because of the staggered enrollment, subset of SMA subjects, and significant mortality. Therefore not all infants enrolled were included in all longitudinal analyses.|||kg||95% Confidence Interval|Mean
2642482|NCT01736553|Secondary|Molecular Biomarkers- SMN Protein Levels SMA Copy Number = 2|Describe and compare the distribution of the putative physiological and molecular biomarkers over the first two years of life in SMA2 vs. healthy control infants.|Up to 24 months|Patients enrolled in the trial at birth. The overall number of participants analyzed (10 and 18) differs from the total enrollment reported in the participant flow (26 and 27) because of the staggered enrollment, significant mortality, subset of SMA subjects, and insufficient sample.|||pg/10^7 PBMC||95% Confidence Interval|Mean
2642483|NCT01736553|Secondary|Molecular Biomarkers- mRNA SMA Copy Number = 2 Cohort|Describe and compare the distribution of the putative physiological and molecular biomarkers over the first two years of life in SMA vs. healthy control infants.|Up to 24 months|The overall number of participants analyzed (14 and 22) differs from the total enrollment in the participant flow (26 and 27) because of the staggered enrollment, subset of patients with SMA, significant mortality, and insufficient sample.|||SMN/HPRT Ratio||95% Confidence Interval|Mean
2642513|NCT01736540|Secondary|Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups|Iron overload due to transfusion therapy was assessed based on chelation status of each participant (i.e. minimally exposed to chelator treatment and chelation-treated patient subgroups). The mean data presented are mean estimates of log transformed data.|2 months|Only participants with valid LIC by MRI were included in the analysis.|||mg Fe/g||95% Confidence Interval|Mean
2642484|NCT01736553|Secondary|Putative Physiological Biomarker- Compound Motor Action Potential Testing (CMAP) SMN Copy Number = 2 Cohort|"Describe and compare the distribution of the putative physiological and molecular biomarkers over the first two years of life in SMA2 vs. healthy control infants.~Maximum ulnar CMAP amplitude and area will be obtained by recording from the abductor digitiminimi muscle following ulnar nerve stimulation at the wrist. All electrophysiologic testing will be performed by certified electromyographers experienced in the assessment of pediatric patients. Maximum values for both negative peak (NP) amplitude and NP area will be obtained. No medications will be used.~This test is done routinely in this population. Pediatric electrodes and each site's standard electromyograph devices will be utilized. The test, while not considered to be painful, may cause some discomfort similar to a static electric shock. Infants may whimper or cry due to the surprise of the shock. Each shock lasts approximately 0.1 millisecond. The testing duration is expected to be approximately 30 seconds."|Up to 24 months|The overall number of participants analyzed (13 and 26) differs from the total enrollment in the participant flow (26 and 27) because of the staggered enrollment, subset of patients with SMA, significant mortality, and tolerance of procedure.|||mV||95% Confidence Interval|Mean
2642485|NCT01736553|Secondary|Motor Function Assessments- The Children's Hospital of Philadelphia Infant Test for Neuromuscular Disorders (CHOP-INTEND) SMN Copy Number =2 Cohort|"Describe and compare the distribution of motor function assessments over the first two years of life in SMA subjects with SMN copy number = 2 versus healthy control infants.~The CHOP-INTEND is a reliable and validated, comprehensive assessment of the postural and selective control of movement needed by infants. It is a clinician-rated questionnaire developed to assess motor skill in spinal muscular atrophy type I. The 16 items are scored from 0 to 4. The global score ranges from 0 to 64, a higher score indicating better motor skills.(Finkel, McDermott, 2014)."|Up to 24 months|The overall number of participants analyzed (14) differs from the total enrollment reported in the participant flow (26) because of the staggered enrollment, subset of infants with SMN2 , and significant mortality. Healthy controls did not complete this visit due to the protocol.|||Scores on a scale||95% Confidence Interval|Mean
2642486|NCT01736553|Secondary|Motor Function Assessments- Test for Infant Motor Performance Screening Items (TIMPSI) SMN Copy Number =2 Cohort|"Describe and compare the distribution of motor function assessments over the first two years of life in SMA subjects with SMN copy number = 2 versus healthy control infants.~The TIMPSI is used to assess the postural and selective control of movement typically used by infants younger than 5 months. The TIMPSI scores were related to an infant's ability to reach. The TIMPSI is a 29-item evaluation that contains 3 item sets: a Screening set, an Easy set, and a Hard set. The Screening set consists of 11 items from the TIMP, each with a 5- to 7-point rating scale; the Easy set has 6 items with 5- or 6-point rating scales and 4 dichotomously scored items; the Hard set has 8 items, 3 with 5-point rating scales and 5 items that are scored dichotomously. The Total score is derived from all subset scores and is the sum of those subset scores. The final score could range from 0 to 99 points. The higher the score the better the functional ability of the participant."|Up to 24 months|The overall number of participants analyzed (14 and 26) differs from the total enrollment reported in the participant flow (26 and 27 respectively) because of the staggered enrollment, subset of infants with SMN2 & significant mortality.|||Scores on a scale||95% Confidence Interval|Mean
2642487|NCT01736553|Secondary|Biomarker Prediction of Risk of Death|Examine whether any of the motor function assessments, putative physiological, or molecular biomarkers predict risk of death in the SMA cohort. Proportional hazards regression models used to determine if motor function scores, mRNA, and protein levels predict death in SMA subjects. Considered each predictor separately modeled as a time-varying covariate (predictor values were allowed to vary as time to death was assessed).|Up to 24 months||||Hazard Ratio||95% Confidence Interval|Mean
2642488|NCT01736553|Primary|Correlation of Biomarkers With Motor Function Tests for Healthy Control Subjects- Weight|In these analyses motor function score was the outcome measure. Correlation was defined as the estimated mean increase per a one unit increase in the biomarker under consideration. A linear mixed effects model was used to estimate the correlation between the biomarker and motor function score. Separate models were used for the TIMPSI and AIMS.|up to 24 months|The overall number of participants analyzed (26 and 26) differs from the total enrollment reported in the participant flow (27) because of the staggered enrollment and significant mortality.|||kg/scale unit||95% Confidence Interval|Mean
2642489|NCT01736553|Primary|Correlation of Biomarkers With Motor Function Tests for Healthy Control Subjects- mRNA|In these analyses motor function score was the outcome measure. Correlation was defined as the estimated mean increase per a one unit increase in the biomarker under consideration. A linear mixed effects model was used to estimate the correlation between the biomarker and motor function score. Separate models were used for the TIMPSI and AIMS.|up to 24 months|Labs were not obtainable for all subjects. The overall number of participants analyzed (26 and 26) differs from the total enrollment reported in the participant flow (27) because of the staggered enrollment, significant mortality and protocol design.|||(SMN/HPRT Ratio)/scale unit||95% Confidence Interval|Mean
2642490|NCT01736553|Primary|Correlation of Biomarkers With Motor Function Tests for Healthy Control Subjects- CMAP|In these analyses motor function score was the outcome measure. Correlation was defined as the estimated mean increase per a one unit increase in the biomarker under consideration. A linear mixed effects model was used to estimate the correlation between the biomarker and motor function score. Separate models were used for the TIMPSI and AIMS.|up to 24 months|The overall number of participants analyzed (26 and 26) differs from the total enrollment reported in the participant flow at each visit (27) because of the staggered enrollment, significant mortality and tolerance of testing.|||mV/scale unit||95% Confidence Interval|Mean
2642491|NCT01736553|Primary|Correlation of Biomarkers With Motor Function Tests for SMA Subjects- Weight|In these analyses motor function score was the outcome measure. Correlation was defined as the estimated mean increase per a one unit increase in the biomarker under consideration. A linear mixed effects model was used to estimate the correlation between the biomarker and motor function score. Separate models were used for the TIMPSI and CHOP-INTEND.|up to 24 months||||kg/scale unit||95% Confidence Interval|Mean
2642514|NCT01736540|Secondary|Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups|Iron overload due to transfusion therapy was assessed based on chelation status of each participant (i.e. minimally exposed to chelator treatment and chelation-treated patient subgroups).|2 months|Only participants with valid T2* by MRI were included in the analysis.|||ms||95% Confidence Interval|Least Squares Mean
2642492|NCT01736553|Primary|Correlation of Biomarkers With Motor Function Tests for SMA Subjects- SMN Protein|In these analyses motor function score was the outcome measure. Correlation was defined as the estimated mean increase per a one unit increase in the biomarker under consideration. A linear mixed effects model was used to estimate the correlation between the biomarker and motor function score. Separate models were used for the TIMPSI and CHOP-INTEND. In the CHOP-INTEND analyses, the correlation at the 24 month visit was not estimable.|up to 24 months|The overall number of participants analyzed (14 and 19) differs from the total enrollment reported in the participant flow (26) because of the staggered enrollment and significant mortality. Therefore not all infants enrolled were included in all longitudinal analyses.|||(pg/10^7 PBMC)/scale unit||95% Confidence Interval|Mean
2642493|NCT01736553|Primary|Correlation of Biomarkers With Motor Function Tests for SMA Subjects- mRNA|In these analyses motor function score was the outcome measure. Correlation was defined as the estimated mean increase per a one unit increase in the biomarker under consideration. A linear mixed effects model was used to estimate the correlation between the biomarker and motor function score. Separate models were used for the TIMPSI and CHOP-INTEND.|up to 24 months||||(SMN/HPRT ratio)/scale unit||95% Confidence Interval|Mean
2642494|NCT01736553|Primary|Correlation of Biomarkers With Motor Function Tests for SMA Subjects- CMAP|In these analyses motor function score was the outcome measure. Correlation was defined as the estimated mean increase per a one unit increase in the biomarker under consideration. A linear mixed effects model was used to estimate the correlation between the biomarker and motor function score. Separate models were used for the TIMPSI and CHOP-INTEND. In the CHOP-INTEND analyses, correlations were not estimable for the 18 and 24 month visits.|up to 24 months|The overall number of participants analyzed (19 and 14) differs from the total enrollment reported in the participant flow (26) because of the staggered enrollment and significant mortality. Therefore not all infants enrolled were included in all longitudinal analyses.|||mV/scale unit||95% Confidence Interval|Mean
2642495|NCT01736553|Primary|Putative Physiological Biomarkers-Weight|Describe and compare the distribution of the putative physiological and molecular biomarkers over the first two years of life in SMA vs. healthy control infants.|Up to 24 months|Subjects enrolled from birth to 6 months. The overall number of participants analyzed (19 and 26) differs from the total enrollment reported in the participant flow (26 and 27) because of the staggered enrollment & significant mortality. Therefore not all infants enrolled were included in all longitudinal analyses.|||kg||95% Confidence Interval|Mean
2642496|NCT01736553|Primary|Molecular Biomarkers- SMN Protein Levels|Describe and compare the distribution of the putative physiological and molecular biomarkers over the first two years of life in SMA vs. healthy control infants.|Up to 24 months|Patients enrolled in the trial from birth to 6 months. The overall number of participants analyzed (15 and 18) differs from the total enrollment reported in the participant flow (26 and 27) because of the staggered enrollment, significant mortality, insufficient sample. Therefore not all infants enrolled were included in all longitudinal analyses.|||pg/10^7 PBMC||95% Confidence Interval|Mean
2642497|NCT01736553|Primary|Molecular Biomarkers- mRNA|"Describe and compare the distribution of the putative physiological and molecular biomarkers over the first two years of life in SMA vs. healthy control infants.~Results were measured in survival motor neurons (SMN), hypoxanthine phosphoribosyltransferase (HPRT) Ratio."|Up to 24 months|Patients enrolled in the trial from birth to 6 months. The overall number of participants analyzed (19 and 22) differs from the total enrollment in the participant flow (26 and 27) because of the staggered enrollment, significant mortality, & insufficient sample. Therefore not all infants enrolled were included in all longitudinal analyses.|||SMN/HPRT Ratio||95% Confidence Interval|Mean
2642498|NCT01736553|Primary|Putative Physiological Biomarker- Compound Motor Action Potential Testing (CMAP)|"Describe and compare the distribution of the putative physiological and molecular biomarkers over the first two years of life in SMA vs. healthy control infants.~Maximum ulnar CMAP amplitude and area will be obtained by recording from the abductor digitiminimi muscle following ulnar nerve stimulation at the wrist. All electrophysiologic testing will be performed by certified electromyographers experienced in the assessment of pediatric patients. Maximum values for both negative peak (NP) amplitude and NP area will be obtained. No medications will be used.~This test is done routinely in this population. Pediatric electrodes and each site's standard electromyograph devices will be utilized. The test, while not considered to be painful, may cause some discomfort similar to a static electric shock. Infants may whimper or cry due to the surprise of the shock. Each shock lasts approximately 0.1 millisecond. The testing duration is expected to be approximately 30 seconds."|Up to 24 months|Patients enrolled in the trial from birth to 6 months. The overall number of participants analyzed (18/ and 26) differs from the total enrollment in the participant flow (26 and 27) because of the staggered enrollment, significant mortality and tolerance of procedure. Therefore not all infants enrolled were included in all longitudinal analyses.|||mV||95% Confidence Interval|Mean
2642499|NCT01736553|Primary|Motor Function Assessments-Alberta Infant Motor Scale (AIMS)|"Linear mixed effects models were used for analyses.~The reason that the number of infants differ from those in participant flow is based upon the protocol. The selection of which secondary test to perform depended upon the score of the TIMPSI that was performed. TIMPSI <41, do CHOP-NTEND. TIMPSI > 41, do AIMS.~The AIMS incorporates the neuromaturational concept and the dynamical systems theory and is used to measure gross motor maturation of infants from birth through the age of independent walking (Piper, Pinnell et al. 1992, Piper, Darrah et al 1994). In the AIMS, the impact of neurological components on motor development is reflected by a sequence of motor skills, which are used as the basis of assessment. The AIMS consists of 58 items, including 4 positions: prone (21 items), supine (9 items), sitting (12 items) & standing(16 items). The highest score available is 58. The higher the score the better the functional ability of the participant."|Up to 24 months|Patients enrolled in the trial from birth to 6 months of age. The overall number of participants analyzed (5 and 26) differs from the total enrollment in each cohort reported in the participant flow (26 and 27) because of the staggered enrollment, significant mortality and protocol design of who was eligible for this second motor measure.|||Scores on a scale||95% Confidence Interval|Mean
2642551|NCT01736475|Primary|Annualized Bleeding Rate (ABR)|Comparisons between prophylactic and on-demand treatment were based on ABR estimates from a negative binomial regression model, taking into account the treatment regimen, target joints and age at screening, and duration of the observation period for efficacy.|9 months|Full Analysis Set|||Bleeds per year||95% Confidence Interval|Least Squares Mean
2642500|NCT01736553|Primary|Motor Function Assessments- The Children's Hospital of Philadelphia Infant Test for Neuromuscular Disorders (CHOP-INTEND)|The TIMPSI motor function testing was done during all of the study visits knowing that the healthy controls would eventually ceiling out. The study design allowed for secondary motor function tests based on the score of the TIMPSI. If infants scored a 41 or above on the TIMPSI they would be tested with the AIMS. If they were below they were tested with the CHOP-INTEND. The CHOP-INTEND is a reliable and validated, comprehensive assessment of the postural and selective control of movement needed by infants. It is a clinician-rated questionnaire developed to assess motor skill in spinal muscular atrophy type I. The 16 items are scored from 0 to 4. The global score ranges from 0 to 64, a higher score indicating better motor skills.(Finkel, McDermott, 2014). All healthy controls based upon scores at 6 months moved on to the AIMS test, therefore no healthy controls completed the CHOP-INTEND. Linear mixed effects models were used for analyses of Motor function outcome data.|Up to 24 months|Patients enrolled in the trial from birth. The overall number of participants analyzed (14 and 0) differs from the total enrollment in each cohort reported in the participant flow (26 and 27, respectively) because of the staggered enrollment, significant mortality, and protocol design of who was eligible for this second motor measure.|||scores on a scale||95% Confidence Interval|Mean
2642501|NCT01736553|Primary|Motor Function Assessments- Test for Infant Motor Performance Screening Items (TIMPSI)|"Describe & compare the distribution of motor function assessments over the first two years of life in SMA vs. healthy control infants.~The TIMPSI is used to assess the postural and selective control of movement typically used by infants younger than 5 months. The TIMPSI scores were related to an infant's ability to reach. The TIMPSI is a 29-item evaluation that contains 3 item sets: a Screening set, an Easy set, and a Hard set. The Screening set consists of 11 items from the TIMP, each with a 5- to 7-point rating scale; the Easy set has 6 items with 5- or 6-point rating scales and 4 dichotomously scored items; the Hard set has 8 items, 3 with 5-point rating scales and 5 items that are scored dichotomously. The Total score is derived from all subset scores and is the sum of those subset scores. The final score could range from 0 to 99 points. The higher the score the better the functional ability of the participant. Linear mixed effects models were used for analyses."|Up to 24 months|The overall number of participants analyzed (19 and 26) differs from the total enrollment in each cohort reported in the participant flow (26 and 27, respectively) because of the staggered enrollment and significant mortality.|||scores on a scale||95% Confidence Interval|Mean
2642502|NCT01736540|Secondary|Investigator Treatment Decisions Based on MRI Results|"Treatment decisions were recorded after the investigator evaluated the MRI results, in order to assess the impact of such diagnostic test on the overall clinical management of participants with iron overload. Investigators answered the following question: Since the MRI scan, have you changed or are planning to change the management of iron in your subject?."|2 months|Participants, for whom treatment decision questionnaire results were provided and for whom MRI results were available, were included in the analysis.|||Percentage of participants|||Number
2642503|NCT01736540|Secondary|Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy|"Adherence of participants was assessed using an adherence questionnaire. Adherence questionnaires were completed only by participants who received chelating agents. Participants answered yes or no to 6 statements such as Forgot to take pills. Based on the responses to these questions, adherence was classified as low, medium or high."|1 month|Participants who were on iron chelator therapy at screening, and had answered at least one question on the questionnaire and had sufficient information to score the questionnaire, were included in the analysis.|||Percentage of participants|||Number
2642504|NCT01736540|Secondary|Mean Quality of Life (QOL) Scores|Quality of life was assessed using the Short Form 36 (SF-36) Health Survey. The SF-36 consists of 8 sub-scales: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The raw sores of the 8 scales are transformed to a 0 - 100 scale where 0 indicates maximum disability and 100 indicates no disability. There also are two physical and mental health summary measures. Each summary measure is the mean average of the 4 associated sub-scale scores. The range for each summary measure is 0 to 100 where 0 represents maximum disability and 100 represents no disability.|1 month|Only participants with data for each subscale were included in the analysis for that subscale.|||units on a scale||Standard Deviation|Mean
2642505|NCT01736540|Secondary|Mean Number of Erythrocyte Units Transfused in Last 12 Months|Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed.|12 months - retrospective|Participants with 'number of units transfused' data were included in the analysis.|||number of units transfused||Standard Deviation|Mean
2642506|NCT01736540|Secondary|Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days|Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed.|12 months - retrospective|Participants with data on time since their most recent transfusion were included in the analysis.|||percentage of participants|||Number
2642507|NCT01736540|Secondary|Percentage of Participants Transfused With Erythrocytes|Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed.|12 months - retrospective|Participants with a erythrocyte transfusion history were included in the analysis.|||Percentage of participants|||Number
2642508|NCT01736540|Secondary|Mean Blood Magnetic Susceptibility (BMS)|Blood samples were collected to assess BMS. The measurement represents absolute magnetic susceptibility at 1 month. Whole blood magnetic susceptibility was calculated by the addition of the dry weight susceptibility and the contribution of the water driven from the sample.|1 month|Participants with BMS values were analyzed.|||emu/g wet wt/Oe||Standard Deviation|Mean
2642509|NCT01736540|Secondary|Mean LIC According to the Presence or Absence of Retrospective Hepatic Events|Mean LIC according to the presence or absence of hepatic events was assessed for all participant subgroups.|12 months - retrospective|Participants with LIC by MRI were included in the analysis.|||mg Fe/g||Standard Deviation|Mean
2642510|NCT01736540|Secondary|Mean Cardiac T2* According to the Presence or Absence of Retrospective Cardiac Events|Mean cardiac T2* according to the presence or absence of cardiac events was assessed for all participant subgroups. The mean data presented are mean estimates of log transformed data.|12 months - retrospective|Participants with valid T2* by MRI results were included in the analysis.|||log10 (ms)||Standard Deviation|Mean
2642515|NCT01736540|Primary|Cardiac Siderosis Severity|Cardiac siderosis severity was measured by MRI (T2*). The severity grade of siderosis was tiered in 3 levels: mild (T2* >= 20ms), moderate (T2* from 10 to 20ms), and severe (T2* <10ms). Mild cardiac siderosis, by the definitions used in this study, were equivalent to not having cardiac siderosis. Values were compared to published thresholds of iron overload to determine severity of transfusion siderosis in the participant population studied.|2 months|Only participants with valid T2* by MRI were included in the analysis.|||Percentage of participants|||Number
2642516|NCT01736540|Primary|Percentage of Participants With Cardiac and Liver Iron Overload.|Hepatic iron overload (liver siderosis) and cardiac iron overload (cardiac siderosis) in patients with transfusional siderosis (Myelodysplastic syndrome (MDS), thalassaemia major, non-transfusion-dependent thalassaemia (NTDT) and other anaemias) were measured using MRI (R2 by FerriScan and T2*, respectively).|2 months|Only participants with valid T2* by MRI and valid liver iron concentration (LIC) by MRI were included for the cardiac siderosis and liver siderosis analyses, respectively.|||Percentage of participants|||Number
2642517|NCT01736527|Primary|Tear Fluid Levels|Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose|24 hours|The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.|||μg/g||Standard Deviation|Mean
2642518|NCT01736527|Primary|Tear Fluid Levels|Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose|12 hours|The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.|||μg/g||Standard Deviation|Mean
2642519|NCT01736527|Primary|Tear Fluid Levels|Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose|9 hours|The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.|||μg/g||Standard Deviation|Mean
2642520|NCT01736527|Primary|Tear Fluid Levels|Following a single dose of LE gel 0.5% administered into the study eye, tear samples will be collected via a Schirmer strip at 6, 9, 12 and 24 hours following the dose|6 hours|The primary analysis includes all subjects in the safety population with tear samples collected within the corresponding time window.|||μg/g||Standard Deviation|Mean
2642521|NCT01736475|Secondary|Changes in Lipid Panel Assessments From Screening - Cholesterol; High Density Lipoprotein (HDL); Low Density Lipoprotein (LDL); Triglycerides; and Very Low Density Lipoprotein (VLDL)||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.|||mmol/L||Inter-Quartile Range|Median
2642522|NCT01736475|Secondary|Changes in Hematology Laboratory Assessments From Screening - Erythrocytes||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.|||TI/L||Inter-Quartile Range|Median
2642523|NCT01736475|Secondary|Changes in Hematology Laboratory Assessments From Screening - Hemoglobin||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.|||g/L||Inter-Quartile Range|Median
2642524|NCT01736475|Secondary|Changes in Hematology Laboratory Assessments From Screening - Hematocrit||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.|||Percentage red blood cells||Inter-Quartile Range|Median
2642525|NCT01736475|Secondary|Changes in Hematology Laboratory Assessments From Screening - Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets, and Leukocytes||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.|||giga (10^9) cells per liter (Gi/L)||Inter-Quartile Range|Median
2642526|NCT01736475|Secondary|Changes in Clinical Chemistry Laboratory Assessments From Screening - Creatinine, and Bilirubin||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.|||µmol/L||Inter-Quartile Range|Median
2642527|NCT01736475|Secondary|Changes in Clinical Chemistry Laboratory Assessments From Screening - Bicarbonate, Chloride, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN)||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.|||mmol/L||Inter-Quartile Range|Median
2642528|NCT01736475|Secondary|Changes in Clinical Chemistry Laboratory Assessments From Screening - Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase|Alkaline Phosphatase (Alk Phos); Alanine Aminotransferase (Ala Amino); Aspartate Aminotransferase (Asp Amino)|Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.|||Units per Liter||Inter-Quartile Range|Median
2642529|NCT01736475|Secondary|Changes in Clinical Chemistry Laboratory Assessments From Screening - Albumin and Protein||Screening, week 2, week 4, month 3, study completion/termination|Safety Analysis Set - Subset of participants with both screening visit data and follow on time point data.|||g/L||Inter-Quartile Range|Median
2642530|NCT01736475|Secondary|Changes in Vital Signs From Screening - Blood Pressure|Systolic Blood Pressure (SBP) Diastolic Blood Pressure (DBP)|Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination|Safety Analysis Set|||mmHg||Inter-Quartile Range|Median
2642531|NCT01736475|Secondary|Change in Vital Signs From Screening - Respiratory Rate||Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination|Safety Analysis Set|||breaths per minute||Inter-Quartile Range|Median
2642532|NCT01736475|Secondary|Change in Vital Signs From Screening - Pulse Rate||Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination|Safety Analysis Set|||beats per minute||Inter-Quartile Range|Median
2642533|NCT01736475|Secondary|Change in Vital Signs From Screening - Temperature||Screening, week 2, week 4, exposure day 10-15, month 3, study completion/termination|Safety Analysis Set|||Celsius||Inter-Quartile Range|Median
2645023|NCT01714310|Other Pre-specified|Affective Reactivity Index Child Report|Dimensional self-report of irritability, with total score 1-12, and higher scores indicating greater severity.|Baseline through week 12.|||||||
2642534|NCT01736475|Secondary|Pharmacokinetics (Pk) -Time to Maximum Concentration in Plasma (Tmax) (One-stage Clotting Assay)|Tmax in hours will be defined as the time to reach Cmax. Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)|||hours||Standard Deviation|Mean
2642535|NCT01736475|Secondary|Pharmacokinetics (Pk) - Maximum Plasma Concentration (Cmax) (One-stage Clotting Assay)|Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3).|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)|||IU/dL||Standard Deviation|Mean
2642536|NCT01736475|Secondary|Pharmacokinetics (Pk) - Apparent Volume of Distribution at Steady State (Vss) (One-stage Clotting Assay)|"The apparent volume of distribution at steady state (Vss) will be calculated as: Vss = Clearance * Mean Residence Time.~Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)|||dL/kg||Standard Deviation|Mean
2642537|NCT01736475|Secondary|Pharmacokinetics (Pk) - Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC0-∞) (One-stage Clotting Assay)|"Calculated by WinNonlin NCA (Model 201, calculation method: Linear Trapezoidal Linear/Log Interpolation).~Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)|||(IU*hours)/dL||Standard Deviation|Mean
2642538|NCT01736475|Secondary|Pharmacokinetics (Pk) - Incremental Recovery Over Time (One-stage Clotting Assay)|"Incremental recovery (IR) in (IU/dL)/ (IU/kg) calculated as: IR = (Cmax- (C pre-infusion)) / (Dose/kg), where C =concentration.~Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)|||(IU/dL)/(IU/kg)||Standard Deviation|Mean
2642539|NCT01736475|Secondary|Pharmacokinetics (Pk) - Total Body Clearance (One-stage Clotting Assay)|"Clearance in dL/(kg.h) will be calculated as the dose in IU/kg divided by the total area under the curve starting from the begin of infusion (or the end of infusion if start time is not available).~Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)|||dL/(kg*hours)||Standard Deviation|Mean
2642540|NCT01736475|Secondary|Pharmacokinetics (Pk) - Mean Residence Time (One-stage Clotting Assay)|"The mean residence time (MRT) w as calculated as total area under the moment curve divided by the total area under the curve starting from the begin of infusion (or the end of infusion if start time is not available).~Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)|||hours||Standard Deviation|Mean
2642541|NCT01736475|Secondary|Pharmacokinetics (Pk) - Plasma Half-life (One-stage Clotting Assay)|"Terminal half-life calculated as log_e2/λz where λz is the terminal elimination rate constant.~Participants in the pharmacokinetic full analysis set (PKFAS) analysis set received an initial infusion of ADVATE for pharmacokinetic analysis (PK-1) followed by a washout period and an infusion of BAX 855 for a second pharmacokinetic analysis (PK-2). After at least 50 EDs of BAX 855, participants in the PK subgroup received another infusion of BAX 855 for pharmacokinetic analysis (PK-3)."|Within 30 minutes prior to start of infusion; and post-infusion at 10, 30 minutes, and 1, 3, 6, 9, 24, 32, 48, 56, 72 (PK2 and PK3 only), and 96 hours (PK2 and PK3 only).|Pharmacokinetic full analysis set (PKFAS)|||hours||Standard Deviation|Mean
2642552|NCT01736397|Secondary|Change in Hemoglobin Levels From Baseline to End of Treatment|The difference in hemoglobin levels between the value at the end of treatment (week 12) minus the baseline measurement.|12 Weeks|The efficacy analyses were based on the ITT population. The Intent-to-Treat (ITT) population consisted of all subjects who were randomized into the study, had a baseline laboratory value, had taken at least 1 dose of study drug, and had at least 1 post-baseline laboratory value. ANCOVA with LOCF methodology was used.|||g/dL||Standard Deviation|Mean
2642542|NCT01736475|Secondary|Patient Reported Outcomes - Short Form (SF)-36, Change From Baseline to End of Study|Change from Baseline to End of Study for SF-36 Questionnaire is provided. Scores for individual SF-36 categories range from 0 to 100 with higher scores representing better health. Given that higher scores indicate better health-related quality of life (HRQoL) and that the change scores were calculated as the value at study completion minus the value at baseline, a negative change score indicates a worsening of HRQoL.|Baseline; and end of study visit [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm and 6 months (± 2 weeks) for the on-demand arm]|Full Analysis Set - Subset of participants with both baseline and study completion SF-36 scores|||Score on a scale||Standard Deviation|Mean
2642543|NCT01736475|Secondary|Patient Reported Outcomes: Haemo-SYM Questionnaire, Change in Score From Baseline to End of Study|"The HAEMO-SYM has two subscales: pain and bleeds. HAEMO-SYM subscale scores are calculated by taking the mean of the items in each subscale and transforming them to a 0 (none or absent) to 100 (very severe) scale.~Given that higher scores indicate more severe symptoms on the Haemo-SYM and that the change scores were calculated as the value at study completion minus the value at baseline, a negative change score indicates an improvement (reduction in symptoms). Conversely, a positive change score indicates worsening symptoms."|Baseline; and end of study visit [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm and 6 months (± 2 weeks) for the on-demand arm].|Full Analysis Set - Subset of participants with both baseline and study completion HAEMO-SYM scores|||Score on a scale||Standard Deviation|Mean
2642544|NCT01736475|Secondary|Immunogenicity - Number of Participants With Positive Inhibitory Antibodies to FVIII, Binding Antibodies to FVIII, PEG-VIII, PEG and Anti-CHO Antibodies at Study Completion/Termination|"Number of participants who received BAX855, with immunogenicity data from study completion/termination visit.~FVIII = factor VIII; PEG-VIII = polyethylene glycol-factor VIII; Anti-CHO = Anti-Chinese hamster ovary"|From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].|Safety Analysis Set (SAS) - who received BAX855 during the study period. Note: one participant was assigned to the prophylactic arm but did not receive BAX855 (only received ADVATE, during the screening period).|||Participants|||Number
2642545|NCT01736475|Secondary|Percentage of Participants With Adverse Events|Adverse Events (AEs) and Serious Adverse Events (SAEs)|From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].|Safety Analysis Set (SAS) - All participants treated with BAX 855 were analyzed as a single group (ie on-demand and prophylaxis treatment regimens were analyzed as a single group).|||percent of participants|||Number
2642546|NCT01736475|Secondary|Weight-adjusted Consumption of BAX 855 - Per Treatment of Bleeding Episode (BE) and Per BE for Maintenance of Hemostasis|Infusions per bleeding episode for maintenance of hemostasis only includes infusions following the resolution of a bleed to maintain hemostasis.|Treatment of Bleeding Episode (BE): Minor/Moderate BE every 12 to 24 hours until bleeding is resolved; Major BE every 8 to 12 hours until bleeding is resolved. Per BE for Maintenance of Hemostasis: within 48 hours after bleeding episode resolution.|"Full Analysis Set (FAS) - Note: data analyzed by subsets of FAS (1) participants who received BAX855 for treatment of BEs (2) BAX855 for Maintenance of Hemostasis.~Subset of participants who received BAX855 for treatment of BEs: N= 92~Subset BAX855 for Maintenance of Hemostasis participants: N=16"|||IU/kg|Bleeds|Standard Deviation|Mean
2642547|NCT01736475|Secondary|Weight-adjusted Consumption of BAX 855 - Per Prophylactic Infusion and Pharmacokinetic (PK) Infusion||Prophylactic Infusion: ≥50 exposure days or 6 months (±2 weeks), whichever occurs last. PK Infusion: PK #1 Pre-infusion within 30 minutes; Post-infusion 10 min, and 0.5, 1, 3, 6, 24, 32, 48, 56 hours (h). PK #2 also at Post-infusion 96h|"Full Analysis Set (FAS) - Note: data analyzed by subsets of FAS (1) participants who received BAX855 prophylactic infusion or (2) BAX855 pharmacokinetic (PK) participants.~Subset of participants who received BAX855 prophylactic infusion: N= 120~Subset of BAX855 pharmacokinetic (PK) participants: N=26"|||IU/kg|Infusions|Standard Deviation|Mean
2642548|NCT01736475|Secondary|Number of Participants With ≤1, 2, 3, 4, 5, 6, or >6 Month Time Intervals Between Bleeding Episodes or no Bleeding Episodes|Interval between Bleeds in months was calculated as: Observation period for efficacy (in days)/(number of bleeds)*(12/365.2425)|From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].|Study participants from the Full Analysis Set (FAS) who received BAX855 during the study period. Note: one participant was assigned to the prophylactic arm (thus was included in the FAS) and received only ADVATE during the screening period.|||Participants|||Number
2642549|NCT01736475|Secondary|Average Number of BAX 855 Infusions Needed for the Treatment of Bleeding Episodes||From first exposure to BAX 855 until the end of the study, [at least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm; and 6 months (± 2 weeks) for the on-demand arm].|Participants from the Full Analysis Set who experienced at least one bleeding episode.|||Infusions||Standard Deviation|Mean
2642550|NCT01736475|Secondary|Rate of Success of BAX 855 for Treatment of Bleeding Episodes|Success in the control of bleeding was defined as a rating of excellent or good using the Efficacy Rating Scale for Treatment of Bleeding Episodes measured 24 hours after initiation of treatment for the bleeding episode. EXCELLENT: Full relief of pain and cessation of objective signs of bleeding (eg, swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion is required for the control of bleeding. Administration of further infusions to maintain hemostasis would not affect this scoring. GOOD: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution. FAIR: Probable and/or slight relief of pain and slight improvement in signs of bleeding after a single infusion. Required more than 1 infusion for complete resolution. NONE: No improvement or condition worsens.|At least 50 exposure days or 6 months (±2 weeks), whichever occurs last, for the prophylaxis arm and 6 months (± 2 weeks) for the on-demand arm.|Full Analysis Set - All bleeding episodes treated with BAX 855 in participants on on-demand and prophylaxis treatment regimens were analyzed as a single group.|||Bleeding episodes|Bleeding episodes|95% Confidence Interval|Number
2645024|NCT01714310|Other Pre-specified|Children's Depression Rating Scale|Clinician completed dimensional rating of depressive symptoms.|Baseline through week 12.|||||||
2642553|NCT01736397|Secondary|Change in Ferritin Levels From Baseline to End of Treatment|The difference in ferritin levels between the value at the end of treatment (week 12) minus the baseline measurement.|12 Weeks|The efficacy analyses were based on the ITT population. The Intent-to-Treat (ITT) population consisted of all subjects who were randomized into the study, had a baseline laboratory value, had taken at least 1 dose of study drug, and had at least 1 post-baseline laboratory value. ANCOVA with LOCF methodology was used.|||ng/mL||Standard Deviation|Mean
2642554|NCT01736397|Primary|Change in Serum Phosphorus Levels From Baseline to End of Treatment|The difference in serum phosphorus between the value at the end of treatment (week 12) minus the baseline measurement.|12 Weeks|The efficacy analyses were based on the ITT population. The Intent-to-Treat (ITT) population consisted of all subjects who were randomized into the study, had a baseline laboratory value, had taken at least 1 dose of study drug, and had at least 1 post-baseline laboratory value. ANCOVA with LOCF methodology was used.|||mg/dL||Standard Deviation|Mean
2642555|NCT01736397|Primary|Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment|The difference in TSAT between the value at the end of treatment (week 12) minus the baseline measurement.|12 Weeks|Efficacy analyses were based on Intent-to-Treat (ITT) population, which consisted of all randomized subjects who had a baseline laboratory value, had taken at least 1 dose of study drug, & had at least 1 post-baseline laboratory value. ANCOVA with Last observation carried forward (LOCF) methodology was used.|||% saturation||Standard Deviation|Mean
2642556|NCT01736358|Other Pre-specified|Incidence of Postoperative Side Effects|To find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population.|24 hours after procedure||||number of events|||Number
2642557|NCT01736358|Secondary|Post Operative Pain Scale|To evaluate the post operative pain score using the Visual Analog Scale (VAS) 2 hours after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain.|2 hours after surgery||||score on a scale||Inter-Quartile Range|Median
2642558|NCT01736358|Secondary|Post Operative Pain Score|To evaluate the post operative pain score using the Visual Analog Scale (VAS) 1 hour after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain.|1 hour after surgery||||score on a scale||Inter-Quartile Range|Median
2642559|NCT01736358|Secondary|Post Operative Pain Score|To evaluate the post operative pain score using the Visual Analog Scale (VAS) 30 minutes after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain.|30 minutes after surgery||||score on a scale||Inter-Quartile Range|Median
2642560|NCT01736358|Primary|Post-operative Opioid Requirements|this study will assess the effect of perioperative usage of single-dose of intranasal ketorolac on post operative opioid requirements within 3 hours after surgery.|3 hours after surgery||||mg||Inter-Quartile Range|Median
2642561|NCT01736254|Secondary|Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Gemfibrozil|Venous blood samples were taken on Day 1 for PK parameter estimates of gemfibrozil alone and on Day 13 for PK parameter estimates of gemfibrozil when coadministered with evacetrapib.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Day 1 and Day 13|All participants who received at least 1 dose of evacetrapib or gemfibrozil and had evaluable Tmax data.|||hours||Full Range|Median
2642562|NCT01736254|Secondary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Gemfibrozil|Venous blood samples were taken on Day 1 for PK parameter estimates of gemfibrozil alone and on Day 13 for PK parameter estimates of gemfibrozil when coadministered with evacetrapib.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Day 1 and Day 13|All participants who received at least 1 dose of evacetrapib or gemfibrozil and had evaluable Cmax data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2642563|NCT01736254|Secondary|Pharmacokinetics (PK): Area Under the Concentration Curve Over a 12 Hour Dosing Interval (AUCτ) of Gemfibrozil|Venous blood samples were taken on Day 1 for PK parameter estimates of gemfibrozil alone and on Day 13 for PK parameter estimates of gemfibrozil when coadministered with evacetrapib.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Day 1 and Day 13|All participants who received at least 1 dose of evacetrapib or gemfibrozil and had evaluable AUCτ data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2642564|NCT01736254|Primary|Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib|Venous blood samples were taken on Day 11 for PK parameter estimates of evacetrapib alone and on Day 22 for PK parameter estimates of evacetrapib when coadministered with gemfibrozil.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Day 11 and Day 22|All participants who received at least 1 dose of evacetrapib or gemfibrozil and had evaluable Tmax data.|||hours||Full Range|Median
2642565|NCT01736254|Primary|Pharmacokinetics (PK): Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Evacetrapib|Venous blood samples were taken on Day 11 for PK parameter estimates of evacetrapib alone and on Day 22 for PK parameter estimates of evacetrapib when coadministered with gemfibrozil.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Day 11 and Day 22|All participants who received at least 1 dose of evacetrapib or gemfibrozil and had evaluable AUCτ data.|||nanograms*hours/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2642566|NCT01736254|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib|Venous blood samples were taken on Day 11 for PK parameter estimates of evacetrapib alone and on Day 22 for PK parameter estimates of evacetrapib when coadministered with gemfibrozil.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Day 11 and Day 22|All participants who received at least 1 dose of evacetrapib or gemfibrozil and had evaluable Cmax data.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2642567|NCT01736241|Secondary|Number of Participants Who Developed Anti-LY3053102 Antibodies|LY3053102 anti-drug antibodies (ADA) were assessed at baseline, 15 and 29 days. The number of participants with an initial postbaseline positive titer (defined as a >=2-fold increase in the ADA titer from baseline) anti-drug (LY3053102) ADA at each time point were summarized.|Baseline, up to Day 31|Participants who received at least one dose of LY3053102 or placebo and with evaluable anti-drug (LY3053102) ADA data.|||participants|||Number
2642568|NCT01736241|Secondary|PK: Observed Maximum Drug Concentration (Cmax) of LY3053102|Cmax of LY3053102 from time 0 to 168 hours after study drug administration on Day 1.|Time 0 to 168 hours after study drug administration on Day 1|Participants who received at least one dose of LY3053102 and with evaluable LY3053102 concentration data.|||microgram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2642571|NCT01736215|Secondary|Transferring Iron Binding Capacity (TIBC)|TIBC is a medical laboratory test that measures the blood's capacity to bind iron with transferrin.|Baseline, Week 1 and Week 2|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.|||Mcg per dl||Standard Deviation|Mean
2642572|NCT01736215|Secondary|Serum Iron Level|Serum iron is a test that measures the amount of iron in the blood which is bound to transferrin.|Baseline, Week 1 and Week 2|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'N' signifies participants who were evaluated for this outcome measure.|||Microgram per deciliter (Mcg per dl)||Standard Deviation|Mean
2642573|NCT01736215|Secondary|Serum Ferritin Level|Serum ferritin is the amount of ferritin in a participant's blood. Ferritin is a protein that stores iron and allows the body to use iron.|Baseline, Week 1 and Week 2|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.|||Microgram per liter||Standard Deviation|Mean
2642574|NCT01736215|Secondary|Reticulocyte Count|Reticulocytes are immature red blood cells.|Baseline, Week 1, Week 2, Week 4 and Week 8|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'N' signifies participants who were evaluablated for this outcome measure and 'n' signifies participants who were evaluated for this outcome measure at given time point.|||Nanogram per liter||Standard Deviation|Mean
2642575|NCT01736215|Secondary|Serum Hematocrit Level|Hematocrit is the amount of red blood cells in the blood.|Baseline, Week 1, Week 2, Week 4 and Week 8|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.|||Percentage of red blood cells||Standard Deviation|Mean
2642576|NCT01736215|Secondary|Serum Hemoglobin Level|Hemoglobin is defined as a substance that carries oxygen and gives blood its red color.|Baseline, Week 1, Week 2, Week 4 and Week 8|Participants who received erythropoietin treatment and had the data available at least on Baseline and at all measurable time points of study evaluation period. Here, 'n' signifies participants who were evaluated for this outcome measure at given time point.|||Gram per deciliter (g per dl)||Standard Deviation|Mean
2642577|NCT01736215|Secondary|Number of Participants With C-Reactive Protein (CRP) Level Less Than or Equal to 10.3 or Greater Than 10.4|CRP is a acute serum protein released from liver. It is associated with low hemoglobin or erythropoeitin resistance. Number of participants with CRP level less than or equal to 10.3 or greater than 10.4 were observed.|Baseline|Participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation were analyzed.|||Participants|||Number
2642578|NCT01736215|Secondary|Number of Participants With Serum Erythropoietin (EPO) Level (EPO Less Than or Equal to 45.2 or EPO Greater Than 45.3)|EPO is a hormone secreted by kidney that helps in formation of red blood cells in bone marrow. Number of participants with EPO level less than or equal to 45.2 or greater than 45.3 were observed.|Baseline|Participants who received erythropoietin treatment and who had sufficient data to perform statistical evaluation were analyzed.|||Participants|||Number
2642579|NCT01736215|Primary|Percentage of Participants With Response to Erythropoietin Treatment|Responders of erythropoietin treatment were defined as participants who achieved at least 1 gram per deciliter (g per dl) rise from Baseline in hemoglobin level during within 4-8 weeks or participants who achieved 12 g per dl hemoglobin level at anytime during the study evaluation period (about 8 weeks of follow-up, hemoglobin level reached to 12 g per dl or participants who received blood transfusion at any time of study period) based on National Comprehensive Cancer Institute (NCCN) V3.2009 practice guideline criteria.|8 weeks|Participants who received erythropoietin treatment and had the data available at least on Baseline and at the end of study evaluation period.|||Percentage of participants|||Number
2642580|NCT01736189|Secondary|Percentage of Participants With a Change From Baseline of ≤ 1.0 in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 104|The van der Heijde modified Total Sharp Score (mTSS) is a measure of the level of joint damage. X-rays of hands and feet were taken at the visit. Joints were scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.|Baseline and Week 104|Efficacy analysis set: participants with evaluable data|||percentage of participants|||Number
2642581|NCT01736189|Secondary|Mean Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 104|"The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: no problems (1), some problems (2), extreme problems (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline."|Baseline and Week 104|Efficacy analysis set: participants with evaluable data|||units on a scale||Standard Deviation|Mean
2642591|NCT01736176|Secondary|Percentage of Participants With a Patient Global Impression of Change (PGIC) Response of Improved|"The PGIC is a 7-point response scale. Participants were asked to rate their change in status using the following 7-point scale:~1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse.~The responses of Very much improved, Much improved and Minimally improved on the PGIC were used to define responders."|Week 12 and Week 60|Efficacy dataset|||percentage of participants|||Number
2645025|NCT01714310|Other Pre-specified|Pediatric Anxiety Rating Scale|Clinician completed dimensional assessment of anxiety symptoms.|Baseline through week 12.|||||||
2642582|NCT01736189|Secondary|Percentage of Participants With a Health Assessment Questionnaire Disability Index (HAQ-DI) Score < 0.5 at Week 104|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a self-reported assessment specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. HAQ remission indicating normal physical function is defined as HAQ-DI < 0.5.|At Week 104|Efficacy analysis set: participants with evaluable data|||percentage of participants|||Number
2642583|NCT01736189|Secondary|Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score ≤ 3.3 at Week 104|The SDAI is a validated measure of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm), global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (CRP; mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|At Week 104|Efficacy analysis set: participants with evaluable data|||percentage of participants|||Number
2642584|NCT01736189|Secondary|Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score ≤ 2.8 at Week 104|The Clinical Disease Activity Index (CDAI) is a composite index for assessing rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the participant's global assessment of disease activity (on a visual analog scale [VAS] from 0 to 10 cm), and a physician's global assessment of disease activity (measured on a VAS from 0 to 10 cm) are summed to yield the total score. The total CDAI score ranges from 0 to 78 with higher scores indicating higher disease activity. Remission is defined as a CDAI score ≤ 2.8.|At Week 104|Efficacy analysis set: participants with evaluable data|||percentage of participants|||Number
2642585|NCT01736189|Primary|Percentage of Participants With a Disease Activity Score 28 (DAS28) Score of <2.6 at Week 52|The Disease Activity Score 28 (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR; mm/hr) or C-reactive protein (CRP; mg/dL) level, and the participant's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|At Week 52|Efficacy analysis set: participants with evaluable DAS-28 data|||percentage of participants|||Number
2642586|NCT01736176|Secondary|Change From Baseline in Controlled Oral Word Association Test (COWAT) Verbal Fluency Scores at Week 60|"Letter fluency was assessed using a paper and pen test, in which participants were asked to generate as many words as possible in 60 seconds, starting with the letters F, A, or S.~The COWAT All Letters score is the number of words recalled in all post-baseline assessments, regardless of letter used.~The COWAT Baseline Letter score is the number of words recalled in post-baseline assessments that used the same letter as at Baseline."|Baseline and Week 60|Efficacy dataset with available data|||words||Standard Deviation|Mean
2642587|NCT01736176|Secondary|Change From Baseline in CANTAB Spatial Working Memory Strategy Score at Week 12|CANTAB is a computer-based test of the participant's ability to retain spatial information and to manipulate remembered items in working memory. The Spatial Working Memory module requires that subjects find a blue token in a series of displayed boxes and use these to fill up an empty column, while not returning to boxes where a blue token has been previously found. The Strategy score represents the number of times a participant begins a search with the same box for 6- and 8-box problems. Minimum score is 8 and maximum score is 56. Higher numbers indicate poorer performance.|Baseline and Week 12|Efficacy dataset with available data|||units on a scale||Standard Deviation|Mean
2642588|NCT01736176|Secondary|Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory Between Errors Score at Week 12|CANTAB is a computer-based test of the participant's ability to retain spatial information and to manipulate remembered items in working memory. The Spatial Working Memory module requires that subjects find a blue token in a series of displayed boxes and use these to fill up an empty column, while not returning to boxes where a blue token has been previously found. The between errors score is the number of times the participant revisited a box in which a token was previously found; errors are calculated for 4-, 6-, and 8-box trials. Higher numbers indicate poorer performance.|Baseline and Week 12|Efficacy dataset with available data|||errors||Standard Deviation|Mean
2642589|NCT01736176|Secondary|Change From Baseline in Health-related Productivity|"The Health-Related Productivity Questionnaire (HRPQ) is a generic measure of the impact of disease on the ability of the participant to be productive at paid employment or at performance of household chores. Questions inquire about the amount of time they were scheduled/planned to work, the number of the scheduled/planned hours they were able to work and their ability to be productive for the hours of work they did perform.~Absenteeism: Number of hours not worked due to PD or it's treatments;~Presenteeism: Number of hours of lost productivity while at work due to PD or it's treatments;~Total hours lost: Number of hours lost due to absenteeism and presenteeism"|Baseline, Week 12 and Week 60|Efficacy dataset with available data. Workplace hours lost is calculated for participants who were employed.|||hours||Standard Deviation|Mean
2642590|NCT01736176|Secondary|Treatment Satisfaction Questionnaire Scores|The Treatment Satisfaction Questionnaire (TSQ) is a single item instrument developed by the Sponsor on which the participant indicated their level of satisfaction or dissatisfaction with their PD treatment. The responses are recorded on a Likert-type scale (Very Satisfied, Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied).|Week 12 and Week 60|Efficacy dataset|||Participants|||Count of Participants
2642812|NCT01733368|Primary|Safety Outcomes in CRT Responders and Non-Responders|"Mortality rate,~Rate of cardiovascular hospitalizations and for any cause or~Combined endpoint (death and all-cause hospitalization)"|6 months after implant|Patients experiencing clinical safety event prior to the 6-month follow-up visit.|||Participants|||Count of Participants
2642592|NCT01736176|Secondary|Change From Baseline in PDQ-39 Bodily Discomfort Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642593|NCT01736176|Secondary|Change From Baseline in PDQ-39 Communication Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642594|NCT01736176|Secondary|Change From Baseline in PDQ-39 Cognition Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642595|NCT01736176|Secondary|Change From Baseline in PDQ-39 Social Support Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642596|NCT01736176|Secondary|Change From Baseline in PDQ-39 Stigma Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642597|NCT01736176|Secondary|Change From Baseline in PDQ-39 Emotional Well-Being Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642598|NCT01736176|Secondary|Change From Baseline in PDQ-39 Activities of Daily Living Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642599|NCT01736176|Secondary|Change From Baseline in PDQ-39 Mobility Domain Score|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~Domain scores are calculated by summing the answers to the questions in the domain, dividing by the highest score possible and then multiplying by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642600|NCT01736176|Secondary|Change From Baseline in Parkinson's Disease Questionnaire-39 Item (PDQ-39) Summary Index|"The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing eight domains of health (mobility [10 items], activities of daily living [six items], emotional wellbeing [six items], stigma [four items], communication [three items] and bodily discomfort [three items]) which subjects consider to be adversely affected by the disease. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable).~The PDQ-39 Summary Index (PDQ-SI) is the sum of all answers divided by the highest score possible (i.e., number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0 - 100 scale where lower scores indicate a better perceived health status and higher scores are associated with the more severe symptoms of the disease such as tremors and stiffness."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642601|NCT01736176|Secondary|Change From Baseline in UPDRS Part V: Modified Hoehn and Yahr Staging Score|"The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I - Mentation, Behavior, and Mood~Part II - Activities of Daily Living~Part III - Motor Examination~Part IV - Complications of Therapy (including dyskinesias)~Part V - Modified Hoehn and Yahr Staging~The modified Hoehn and Yahr scale is as follows:~Stage 0: No signs of disease~Stage 1.0: Symptoms are very mild; unilateral involvement only~Stage 1.5: Unilateral and axial involvement~Stage 2: Bilateral involvement without impairment of balance~Stage 2.5: Mild bilateral disease with recovery on pull test~Stage 3: Mild to moderate bilateral disease; some postural instability; physically independent~Stage 4: Severe disability; still able to walk or stand unassisted~Stage 5: Wheelchair bound or bedridden unless aided"|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642602|NCT01736176|Secondary|Change From Baseline in UPDRS Dyskinesia Items Score|"The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I - Mentation, Behavior, and Mood~Part II - Activities of Daily Living~Part III - Motor Examination~Part IV - Complications of Therapy (including dyskinesias)~Part V - Modified Hoehn and Yahr Staging~The dyskinesia items score includes questions 32, 33 and 34 from the complications of therapy section of the UPDRS which address dyskinesia duration, disability, and pain. Each question was answered on a scale from 0 (Normal) to 4 (Severe); the UPDRS dyskinesia items score was computed as the sum of these items and ranged from 0 (not affected) to 12 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642603|NCT01736176|Secondary|Change From Baseline in UPDRS Part IV: Complications of Therapy Score|"The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I - Mentation, Behavior, and Mood~Part II - Activities of Daily Living~Part III - Motor Examination~Part IV - Complications of Therapy (including dyskinesias)~Part V - Modified Hoehn and Yahr Staging~The complications of therapy section includes 11 items addressing dyskinesia duration, disability, and pain, early morning dystonia, offs-predictable, offs-unpredictable, offs-sudden, offs-duration, anorexia-nausea-vomiting, sleep disturbance, and symptomatic orthostasis. Four questions are answered on a scale from 0 (Normal) to 4 (Severe) and seven on a binary scale where 0=No and 1=Yes. The UPDRS Part IV: complications of therapy score was computed as the sum of these items and ranged from 0 (not affected) to 23 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642604|NCT01736176|Secondary|Change From Baseline in UPDRS Part III: Motor Examination Score|"The UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I - Mentation, Behavior, and Mood~Part II - Activities of Daily Living~Part III - Motor Examination~Part IV - Complications of Therapy (including dyskinesias)~Part V - Modified Hoehn and Yahr Staging~The motor examination score includes 17 items addressing speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability, and body bradykinesia. Each question is answered on a scale from 0 (Normal) to 4 (Severe), some items include multiple grades for each extremity. The UPDRS Part III: motor examination score was computed as the sum of these items and ranged from 0 (not affected) to 108 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at baseline (37) and at each time point|||units on a scale||Standard Error|Least Squares Mean
2642629|NCT01735994|Primary|Eating Disorder Examination Questionnaire (EDE-Q)|The Eating Disorder Examination Questionnaire (EDE-Q) assesses eating disorder behaviors through a self-report questionnaire. There are four subscales of the EDE-Q--Restraint, Eating Concern, Shape Concern, and Weight Concern--with scores for each ranging from 0-6. Overall scores also range from 0-6. Higher scores reflect greater severity of eating disorder psychopathology. Subscales are averaged to compute a total score.|18 months||||units on a scale||Standard Error|Mean
2642630|NCT01735916|Secondary|Reverse Remodeling by Echocardiography|"The change in LVEF between study groups.~Note: No subjects completed 24 months of follow-up, so this objective could not be analyzed."|Assessed from baseline visit to 24-month follow-up visit|||||||
2642605|NCT01736176|Secondary|Change From Baseline in UPDRS Part II: Activities of Daily Living (ADL) Score|"The Unified Parkinson's Disease Rating Scale (UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I - Mentation, Behavior, and Mood~Part II - Activities of Daily Living~Part III - Motor Examination~Part IV - Complications of Therapy (including dyskinesias)~Part V - Modified Hoehn and Yahr Staging~The activities of daily living score includes 13 items addressing speech, salivation, swallowing, handwriting, cutting food, dressing, hygiene, turning in bed, falling, freezing, walking, tremor, and sensory complaints. Each question is answered on a scale from 0 (Normal) to 4 (Severe). The UPDRS Part II: activities of daily living score was computed as the sum of these items and ranged from 0 (not affected) to 52 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at baseline (37) and at each time point|||units on a scale||Standard Error|Least Squares Mean
2642606|NCT01736176|Secondary|Change From Baseline in UPDRS Part I: Mentation, Behavior, and Mood Score|"The Unified Parkinson's Disease Rating Scale (UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I - Mentation, Behavior, and Mood~Part II - Activities of Daily Living~Part III - Motor Examination~Part IV - Complications of Therapy (including dyskinesias)~Part V - Modified Hoehn and Yahr Staging~The mentation, behavior, and mood score includes 4 items addressing intellectual impairment, thought disorder, motivation/initiative, and depression. Each question is answered on a scale from 0 (None) to 4 (Severe). The UPDRS Part I: mentation, behavior, and mood score was computed as the sum of these items and ranged from 0 (not affected) to 16 (most severely affected)."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at baseline (37) and each time point|||units on a scale||Standard Error|Least Squares Mean
2642607|NCT01736176|Secondary|Change From Baseline for Unified Parkinson's Disease Rating Scale (UPDRS) Total Score|"The Unified Parkinson's Disease Rating Scale (UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The UPDRS assessment was performed by an approved, trained rater.~The UPDRS was made up of the following sections:~Part I - Mentation, Behavior, and Mood~Part II - Activities of Daily Living~Part III - Motor Examination~Part IV - Complications of Therapy (including dyskinesias)~Part V - Modified Hoehn and Yahr Staging~The Total UPDRS score includes 31 items contributing to three subscales: (I) Mentation, Behavior, and Mood; (II) Activities of Daily Living; and (III) Motor Examination. Each question is answered on a scale from 0 (None) to 4 (Severe); Some questions require multiple grades assigned to each extremity. The UPDRS Total score was computed as the sum of these 3 UPDRS subscales and ranged from 0 to 176, with 176 representing the worst (total) disability, and 0 no disability."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at baseline (37) and each time point|||units on a scale||Standard Error|Least Squares Mean
2642608|NCT01736176|Secondary|"Change From Baseline in Mean Daily Normalized On Time Without Troublesome Dyskinesia Based on PD Diary"|"The PD Diary was completed by the participant for 3 consecutive days prior to each visit. Participants recorded whether they had been On, Off, or Asleep and the severity of their dyskinesias (troublesome or not troublesome) for each 30-minute period during their normal waking time and upon awakening from sleep.~On was defined as time when medication was providing benefit with regard to mobility, slowness, and stiffness. On time without troublesome dyskinesia is a composite of On time without dyskinesia (involuntary twisting, turning movements which are an effect of medication) plus On time with non-troublesome dyskinesia (dyskinesia that does not interfere with function or cause meaningful discomfort).~PD Diary times were normalized to a 16-hour waking time to account for variation in participants' sleep time. Normalized PD Diary times at a given visit were calculated as the average normalized time from the PD Diary for the 3 days prior to the visit."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||hours||Standard Error|Least Squares Mean
2642609|NCT01736176|Secondary|"Change From Baseline in Mean Daily Normalized Off Time Based on Parkinson's Disease Diary"|"The Parkinson's Disease Diary was completed by the participant for 3 consecutive days prior to each visit for the full 24 hours of each day. Participants recorded whether they had been On, Off, or Asleep and the severity of their dyskinesias (troublesome or not troublesome) for each 30-minute period during their normal waking time and upon awakening from time asleep.~Off time was defined as time when medication has worn off and was no longer providing benefit with regard to mobility, slowness, and stiffness.~Parkinson's Disease Diary times were normalized to a 16-hour waking time to account for variation in participants' sleep time. Normalized PD Diary times at a given visit were calculated as the average normalized time from the PD Diary for the 3 days prior to the visit."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||hours||Standard Error|Least Squares Mean
2642610|NCT01736176|Secondary|Change From Baseline in NMSS Miscellaneous Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS miscellaneous domain score ranges from 0 to 48 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642611|NCT01736176|Secondary|Change From Baseline in NMSS Sexual Function Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS sexual function domain score ranges from 0 to 24 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642612|NCT01736176|Secondary|Change From Baseline in NMSS Urinary Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS urinary domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642613|NCT01736176|Secondary|Change From Baseline in NMSS Gastrointestinal Tract Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS gastrointestinal tract domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642614|NCT01736176|Secondary|Change From Baseline in NMSS Attention/Memory Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS attention/memory domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642615|NCT01736176|Secondary|Change From Baseline in NMSS Perceptual Problems/Hallucinations Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS perceptual problems/hallucinations domain score ranges from 0 to 36 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642616|NCT01736176|Secondary|Change From Baseline in NMSS Mood/Cognition Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS mood/cognition domain score ranges from 0 to 72 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642617|NCT01736176|Secondary|Change From Baseline in NMSS Sleep/Fatigue Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS sleep/fatigue domain score ranges from 0 to 48 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time point|||units on a scale||Standard Error|Least Squares Mean
2642618|NCT01736176|Secondary|Change From Baseline in NMSS Cardiovascular Domain Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; domain scores are obtained by summing the item scores. The NMSS cardiovascular including falls domain score ranges from 0 to 24 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12 and Week 60|Efficacy dataset with available data at each time points|||units on a scale||Standard Error|Least Squares Mean
2642642|NCT01735630|Secondary|Change From Baseline in ADCS-ADL Scores|The Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) (Galasko et al 1997) is a functional assessment that measures instrumental and basic activities of daily living. The total score for the 23-item ADCS-ADL ranges from 0 to 78 points, with lower scores indicating greater impairment in function.|Week 12|mITT population with available data for ADCS-ADL Scores|||units on a scale||Standard Error|Mean
2642619|NCT01736176|Secondary|Change From Baseline to Week 60 in the Non-Motor Symptom Scale (NMSS) Total Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; the total score is obtained by summing the item scores. The NMSS total score ranges from 0 to 360 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 60|Efficacy dataset with available data at baseline and week 60|||units on a scale||Standard Error|Least Squares Mean
2642620|NCT01736176|Secondary|Number of Participants Who Used Healthcare Resources Through Week 60|"Use of healthcare resources was assessed by the investigator using the Health Resource Utilization Questionnaire (HRUQ), a questionnaire developed by the Sponsor regarding the use of healthcare resources due to the participant's Parkinson's disease. The standard version of the questionnaire addressed the following questions over the last 3 months:~Has the subject had a visit to an emergency room?~Has the subject had an outpatient visit to any of the following healthcare providers?~Has the subject been visited in his or her place of residence by a health care professional?~Has the subject received assistance from either of the following for their Parkinson's disease in their home?~Has the subject needed to contact either of the following for immediate assistance related to their Parkinson's disease?~Have family members or friends had to miss any paid work due to the subject's Parkinson's disease?~Has the subject fallen during the past month?"|Week 60|Safety dataset with available data|||Participants|||Count of Participants
2642621|NCT01736176|Secondary|Number of Participants With Adverse Events|"Adverse events (AEs) related to treatment are those the investigator determined as having a reasonable possibility being related to study drug based on evidence to suggest a causal relationship between the study drug and the adverse event.~A severe AE was defined as an adverse event that caused considerable interference with the participant's usual activities and might be incapacitating or life-threatening.~Serious AEs were defined as those that were life-threatening or resulted in death, hospitalization or prolongation of hospitalization, a congenital anomaly, persistent or significant disability/incapacity, or important medical events requiring medical or surgical intervention to prevent a serious outcome."|Weeks 1-4 and Overall (from Week 1 through 30 days after the end of the LCIG Treatment Period; median duration of LCIG device exposure was 428 days)|The Safety dataset|||Participants|||Count of Participants
2642622|NCT01736176|Secondary|Number of Participants Who Used Healthcare Resources During the First 4 Weeks|"Use of healthcare resources was assessed by the investigator using the Health Resource Utilization Questionnaire (HRUQ), a questionnaire developed by the Sponsor regarding the use of healthcare resources due to the participant's Parkinson's disease. The Week 4 version of the questionnaire addressed the following questions during the first four weeks after the PEG-J procedure:~Has the subject had a visit to an emergency room?~Has the subject had a visit to an urgent care?~Has the subject had an outpatient visit to a neurologist?~Has the subject had an outpatient visit to a gastroenterologist, surgeon, or interventional radiologist?~Has the subject had an outpatient visit to a primary care physician?~Has the subject called the nursing support line?~Has the subject called a physician?"|Weeks 1-4|The Safety dataset included all participants who underwent the PEG-J placement procedure|||Participants|||Count of Participants
2642623|NCT01736176|Primary|Change From Baseline to Week 12 in the Non-Motor Symptom Scale (NMSS) Total Score|"The NMSS measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe) and frequency is rated on a scale from 1 (rarely) to 4 (very frequent).~Item scores are calculated as the product of severity and frequency; the total score is obtained by summing the item scores. The NMSS total score ranges from 0 to 360 with a lower score indicating fewer symptoms; a negative change from baseline indicates improvement in symptoms."|Baseline and Week 12|The Efficacy dataset included all participants who received at least 1 infusion of LCIG study drug and had a baseline and LCIG Treatment Period observation for at least one efficacy or health outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2642624|NCT01736085|Secondary|Percentage of Smokers Making a 24-hour Quit Attempt|At the follow up evaluation, subjects will be asked if they have made a quit attempt that lasted at least 24 hours.|Two months post enrollment|those evaluated at 2-months; we are looking at the marginal means|||Participants|||Count of Participants
2642625|NCT01736085|Primary|Number of Participants With Six Months Prolonged Abstinence|At seven months post enrollment we will conduct a brief telephone survey to assess smoking status. The information obtained will allow us to determine six month prolonged abstinence rates.|Seven months post enrollment|intent-to-treat; we are looking at the marginal means|||Participants|||Count of Participants
2642626|NCT01735994|Secondary|Secondary Outcomes - BMI|Body Mass Index (BMI) (self-reported) is a measure of kg/m^2.|18 months||||kg/m^2||Standard Error|Mean
2642627|NCT01735994|Primary|Number of Subjective and Objective Binge Episodes as Measured by the Eating Disorder Examination Questionnaire (EDE-Q)|Frequency of subjective and objective binge episodes is reported.|18 months||||episodes||Standard Error|Mean
2642628|NCT01735994|Secondary|Secondary Outcomes|"Internalization of the Sport-Specific Thin-Ideal (ISTI) measures thin-ideal internalization specific to athletes (average of items from 1-5; higher scores mean worse outcome).~Teammate Relationship Health (TRH) measures relational health with teammates (scores from 8-40; higher scores mean better outcome).~Ideal-Body Stereotype Scale - Revised (IBSS-R) assesses internalization of the traditional thin-ideal (scores from 1-10, higher scores mean worse outcome).~Positive and Negative Affect Scale - Revised (PANAS-X) assesses negative affect (average of items from 1-5; higher scores mean worse outcome).~Intervention Suitability Expectations (ISE) assesses perceived suitability and expectations of the intervention (average of total scores from 4-46; higher scores mean better outcome).~Knowledge of the Female Athlete Triad (KFAT) measures participant understanding of the Female Athlete Triad (each correct answer = 1, scores from 0-10; higher scores mean better outcome)."|18 months||||score on a scale||Standard Error|Mean
2642631|NCT01735916|Secondary|Quality of Life (QoL)|"The quality of life between study groups and the change in quality of life over time between study groups using clinically accepted quality of life measures.~Note: No subjects completed 24 months of follow-up, so this objective could not be analyzed.~Two QOL questionnaires were used in the study.~EQ-5D: scores typically range from 0-1, where higher scores reflect better quality of life KCCQ: scores range from 0-100, where higher scores reflect better quality of life"|Assessed from baseline visit to 24-month follow-up visit|||||||
2642632|NCT01735916|Secondary|Recurrent HF Events|"The frequency of HF events between the study groups~Note: No endpoints were reached, so this objective was not analyzed~- HF Event, defined as either:~Inpatient hospitalization for HF, or~Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay"|From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months|||||||
2642633|NCT01735916|Secondary|Mortality or Heart Failure Morbidity or Worsening Systolic Function|"Secondary Composite Efficacy Endpoint: The time to first event, with event defined as:~All-cause mortality~HF Event, defined as either:~Inpatient hospitalization for HF, or~Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay, or~Worsening systolic function meeting an ICD/CRT-D indication, defined as:~A drop in LVEF to 35% or below, with an absolute decrease of greater than or equal to 10%, after maximum tolerated doses of guideline HF medications have been established~Note: No endpoints were reached, so this objective was not analyzed"|From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months|||||||
2642634|NCT01735916|Secondary|Mortality|"Time to death between the study groups~Note: No endpoints were reached, so this objective was not analyzed"|From date of randomization to date of death, for a minimum of 24 months and up to 60 months|||||||
2642635|NCT01735916|Primary|System-related Complication|"Primary Safety Endpoint: Time to first system-related complication in subjects with a successful implant.~Note: Because of the small number of subjects, number of complications was noted between arms and a time to event analysis was not performed.~Complication is defined as: An adverse event that results in death, involves any termination of significant device function, or requires an invasive intervention"|From the date of implant to the date of 6 month follow-up visit||||Complications|||Number
2642636|NCT01735916|Primary|Mortality or Heart Failure Morbidity|"Primary Efficacy Endpoint: The time to first event, with event defined as:~All-cause mortality, or~HF Event, defined as either:~Inpatient hospitalization for HF, or~Outpatient event requiring invasive clinical intervention and management for HF (i.e. IV diuretics, ultrafiltration, or equivalent) and overnight stay~Note: No endpoints were reached, so this objective was not analyzed"|From date of randomization to date of event, assessed for a minimum of 24 months and up to 60 months|||||||
2642637|NCT01735877|Secondary|Modified Rankin Scale (mRS)|"0 - No symptoms at all / 1 - No significant disability despite symptoms / 2 - Slight disability / 3 -Moderate disability, but able to walk without assistance / 4 - Moderate disability and unable to walk without assistance / 5 - Severe disability / 6 - death~0-2: Good outcome 3-6: Poor outcome"|Baseline, 1,3 and 6 months||||participants|||Number
2642638|NCT01735877|Primary|Change From Baseline in Picture Identification Task at 1,3, and 6 Months|PIT consisted of 10 pictures on A4 size paper and patients were asked to identify pictures. More the number of pictures identified, lesser was the neglect.|Baseline, 1,3 and 6 months|The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)|||pictures||95% Confidence Interval|Mean
2642639|NCT01735877|Primary|Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months|"The Line Bisection Test (LBT) consisted of three horizontal black lines, 20 cm long, one to the right, one central and one to the left side of a sheet of white paper (21cms X 30 cms). The patients were asked to ﬁnd and mark the centre of each line in turn. Errors away from true midline were measured, with leftward errors being given a negative sign, rightward errors a positive sign.~We took an absolute value for the change in error. The values for baseline to 1 month were calculated by subtracting baseline values from 1 month values. Then, the mean change was calculated for baseline to 1 month. Similar method was followed for the calculation of mean change in baseline to 3 months and 6 months.~The patients responses were similar for the three lines that they marked hence we took the first line for the interpretation. None of the patients had extreme errors like missed marking at 3 and 6 months."|Baseline, 1,3 and 6 months|The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)|||cms||95% Confidence Interval|Mean
2642640|NCT01735877|Secondary|Functional Independence Measure|"The FIM consists of 13 motor and 5 social-cognitive items, assessing self-care, sphincter management, transfer, locomotion, communication, social interaction and cognition.14 It uses a 7-level scale anchored by extreme rating of total dependence as 1 and complete independence as 7; the intermediate levels are: 6 modiﬁed independence, 5 supervision or set-up, 4 minimal contact assistance, 3 moderate assistance and 2 maximal assistance.~For the purpose of analysis we divided FIM into two categories ≤5 dependent, ≥6 independent."|Baseline, 1, 3 and 6 months|The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)|||participants|||Number
2642641|NCT01735877|Primary|Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months|"The SCT consisted of a page containing 52 large stars, 10 short words and 13 letters, randomly positioned, with 56 small stars interspersed. Subjects were instructed to cross out (with a black pen) all the small stars across the page. The tester demonstrated by crossing out the two central stars. The cut off score to establish presence of unilateral visual neglect were: 51 or fewer stars cancelled for SCT.~Minimum score: 0 Maximum score: 54~Higher scores: better outcome"|Baseline, 1,3 and 6 months|The number of participants are different as mentioned in the flow algorithm since 1 patient from the control group died at 3 months follow up. This patient is included in secondary outcome measures i.e. modified Rankin Scale (mRS)|||units on a scale||95% Confidence Interval|Mean
2644694|NCT01717014|Secondary|Usability: Manueverability|Manueverability measured by surgeon usability questionnaire. Question: Maneuverability of Radial reload during the procedure was adequate|Operatively||||% of cases surgeon agree/strongly agree|||Number
2642643|NCT01735630|Secondary|Change From Baseline in MMSE Scores|The Mini-Mental State Exam (MMSE) (Folstein et al 1975) is a brief cognitive test assessing general cognitive function that has been employed in numerous clinical trials of products approved for the treatment of AD. The score can range from 0 to 30, with lower scores indicating greater impairment in function.|Week 12|mITT population with available data for MMSE Scores|||units on a scale||Standard Error|Mean
2642644|NCT01735630|Secondary|Change From Baseline in NPI Total Scores|The NPI (Cummings et al 1994) is a behavioral measure that assesses psychopathology in dementia subjects. It evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, nighttime behavior disturbances, and appetite and eating abnormalities. Higher scores on the NPI are associated with greater frequency and severity of symptoms. The scale range is 0-144.|Week 12|mITT population with available data for NPI Total Scores|||units on a scale||Standard Error|Mean
2642645|NCT01735630|Secondary|Change From Baseline in Modified-ADCS-CGIC Agitation Scores|The Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) is a widely used scale for the global assessment of change in AD trials.It is a 7-point Likert scale that ranges from marked improvement scored as 1 to marked worsening scored as 7, with no change scored as 4. The range is from 1 to 7. Higher scores indicate worsening agitation.|Week 12|mITT population with available data for Modified-ADCS-CGIC Agitation Scores|||units on a scale||Standard Error|Mean
2642646|NCT01735630|Primary|Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A).|The NPI-C (de Medeiros et al 2010) is a validated and reliable behavioral measure that assesses psychopathology in dementia subjects. It evaluates 14 neuropsychiatric disturbances common in dementia.Higher scores on the NPI-C are associated with a greater clinical severity of symptoms. The NPI-C Agitation and Aggression score ranges from 0-63. The analysis of the NPI-C A+A score was performed on the mITT population.|Week 12|mITT|||units on a scale||Standard Error|Mean
2642647|NCT01735617|Secondary|AUC Values (Pmol*h/L) for ACTH|AUC values (pmol*h/L) for ACTH for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h|Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)||||pmol*h/L||Standard Deviation|Mean
2642648|NCT01735617|Secondary|AUC Values (Nmol*h/L) for 17-OHP|AUC values (nmol*h/L) for 17-OHP for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h|Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)||||nmol*h/L||Standard Deviation|Mean
2642649|NCT01735617|Secondary|AUC Values (Nmol*h/L) for Androstenedione|AUC values (nmol*h/L) for Androstenedione for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h|Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)||||nmol*h/L||Standard Deviation|Mean
2642650|NCT01735617|Secondary|ACTH Levels at 0700h, 1700h and 2300h|ACTH levels at 0700h, 1700h and 2300h|Specified time points (0700h, 1700h and 2300h)||||pmol/L||Standard Deviation|Mean
2642651|NCT01735617|Secondary|Androstenedione Levels at 0700h, 1700h and 2300h|Androstenedione levels at 0700h, 1700h and 2300h|Specified time points (0700h, 1700h and 2300h)||||nmol/L||Standard Deviation|Mean
2642652|NCT01735617|Secondary|17-OHP Levels at 0700h, 1700h and 2300h|17-OHP levels at 0700h, 1700h and 2300h|Specified time points (0700h, 1700h and 2300h)||||nmol/L||Standard Deviation|Mean
2642653|NCT01735617|Secondary|The Percentage of Patients With 17-OHP and Androstenedione Levels at 0700h Within Proposed Optimal Ranges Whilst on Chronocort and Whilst on Standard Therapy (at Baseline)|Proposed optimal ranges of 17-OHP: 300-1200ng/dl Proposed optimal ranges of androstenedione: 40-150ng.dl for males and 30-200ng/dl for females|Specific time point (0700hrs)||||percentage of participants|||Number
2642654|NCT01735617|Primary|Pharmacokinetic Profile (Tmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia|Time to maximum plasma concentration (tmax)|24 hours|All treated subjects|||Hours||Standard Deviation|Mean
2642655|NCT01735617|Primary|Pharmacokinetic Profile (AUC0-24) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia|Area under the curve (AUC) from 0 to 24 hours (sampling occurs at the following timepoints: 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)|24 hours (at 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)|All treated subjects|||h*nmol/L||Standard Deviation|Mean
2642656|NCT01735617|Primary|Pharmacokinetic Profile (Cmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia|The maximum plasma concentration (Cmax) of chronocort|24 hours|All treated subjects|||nmol/L||Standard Deviation|Mean
2642657|NCT01735396|Secondary|Testosterone|Post-treatment changes in testosterone|up to 12 weeks|data not collected||||||
2642658|NCT01735396|Secondary|Safety of Abiraterone|To determine the safety of abiraterone Adverse events as defined by CTCAE v4. Number of participants with serious adverse events grade 4 or 5|up to 12 weeks||||Participants|||Count of Participants
2642659|NCT01735396|Secondary|Bone Scan|"post-treatment changes in bone scans (as per PCWG2 guidelines) (no new lesions versus new lesions.)"|up to 12 weeks|data not collected||||||
2642660|NCT01735396|Secondary|Time to Progression|post-treatment changes in measurable disease by time to disease progression (as per PCWG2 guidelines)|up to 12 weeks|data not collected||||||
2642661|NCT01735396|Secondary|Response Assessment|Post-treatment changes in measurable disease by RECIST - Response Evaluation Criteria in Solid Tumors Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|up to 12 weeks||||Participants|||Count of Participants
2642676|NCT01735175|Secondary|Frequency of Infections by Cycle and Across All Cycles|"The number of patients with infections was recorded for each cycle and across all cycles. Infections were identified by the AE documentation page selecting all events coded with System Organ Class Infections and Infestations."|across all cycles (18 weeks)|Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set|||Participants|||Count of Participants
2642662|NCT01735396|Primary|Number of Participants With ≥ 30% Change in PSA|The primary objective of this study is to determine a correlation between inherited genetic polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in AA patients with castration-resistant prostate cancer treated with Abiraterone. The primary endpoint is the percent change in PSA from baseline to 12 weeks. A decline of ≥ 30% will be correlated with germline SNPs.|baseline and 12 weeks||||Participants|||Count of Participants
2642663|NCT01735214|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Left Eye|IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.|Baseline, Week 12|All participant with IOP data at Baseline and Week 12 for analysis.|||mmHg||Standard Deviation|Mean
2642664|NCT01735214|Secondary|Percentage of Participants Reaching Individual IOP Target After 12 Weeks||12 Weeks|All participants|||percentage of participants|||Number
2642665|NCT01735214|Secondary|Physician Assessment of Efficacy Using a 5-Point Scale|The physician evaluated efficacy (IOP lowering) using a 5-Point Scale: IOP lower than target, Reached Target IOP, IOP decreased but target not reached, No change or IOP increased. The percentage of participants in each category is reported.|12 Weeks|All participants.|||percentage of participants|||Number
2642666|NCT01735214|Secondary|Physician Assessment of Adherence to New Treatment Using a 4-Point Scale|The physician assessed the participant's adherence to new treatment using the following scale: Not Applicable, Worse, Equal or Better. The percentage of participants in each category is reported.|12 Weeks|All Participants|||percentage of participants|||Number
2642667|NCT01735214|Secondary|Percentage of Participants Who Continue the New Treatment After 12 Weeks||12 Weeks|All participants|||percentage of participants|||Number
2642668|NCT01735214|Secondary|Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks||12 Weeks|All participants.|||percentage of participants|||Number
2642669|NCT01735214|Secondary|Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale|The physician evaluated the patient's tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.|12 Weeks|All participants with data available for analysis.|||percentage of participants|||Number
2642670|NCT01735214|Secondary|Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale|The patient evaluated the tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.|12 Weeks|All participants with available data.|||percentage of participants|||Number
2642671|NCT01735214|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Right Eye|IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.|Baseline, Week 12|All participant with IOP data at Baseline and Week 12 for analysis.|||mmHg||Standard Deviation|Mean
2642672|NCT01735201|Secondary|Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 1 Hour Post-Dose on Day 28|Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 1 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 28-hour 1|Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.|||Percentage of participants|||Number
2642673|NCT01735201|Secondary|Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both CEA and SSA at 0.5 Hour Post-Dose on Day 28|Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed at 0.5 hour post-dose on Day 28. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 28-hour 0.5|Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.|||Percentage of participants|||Number
2642674|NCT01735201|Primary|Percentage of Participants With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject Self-Assessment (SSA)|Percentage of participants with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score were assessed on Day 28 hours 2 to 12. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 28-hours 2 to 12|Modified intent-to-treat population included all randomized patients who applied study medication during the study, had both CEA and SSA measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.|||Percentage of participants|||Number
2642675|NCT01735175|Secondary|Mortality Due to Infection|Number of patients with death due to infections|Study course (41 weeks)|FAS set = full analysis set|||Participants|||Count of Participants
2644695|NCT01717014|Secondary|Usability: Access|Access measured by surgeon usability questionnaire|Operatively||||% of cases surgeon agree/strongly agree|||Number
2642677|NCT01735175|Secondary|Time to ANC Recovery in Days in Cycle 1|Time to absolute neutrophil count (ANC) recovery in Cycle 1 was defined as the time in days from ANC nadir until the patient's ANC had increased to ≥ 2 × 10^9 cells/L. Only the evaluable patients with a depth of ANC in Cycle 1 and a later increase of ANC ≥ 2 × 10^9 cells/L are given.|across Cycle 1 (3 weeks)|FAS set = full analysis set|||days||Standard Deviation|Mean
2642678|NCT01735175|Secondary|Number of Patients With ANC Nadir Per Day in Cycle 1|Numbers of patients with ANC nadir based per day during Cycle 1 are given.|Cycle 1 (3 weeks)|FAS set = full analysis set|||Participants|||Count of Participants
2642679|NCT01735175|Secondary|Depth of ANC Nadir in Cycle 1|The depth of ANC nadir was defined as the patient's lowest ANC (10^9 cells/L) in Cycle 1. Only the evaluable patients with a depth of ANC in Cycle 1 are given.|Cycle 1 (3 weeks)|FAS set = full analysis set|||10^9 cells/L||Standard Deviation|Mean
2642680|NCT01735175|Secondary|Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles|Fever was defined as an oral temperature ≥ 38.3°C. Fever episodes were characterized by maximum oral temperature and the number of patients who had fever at least once.|across al cycles (18 weeks)|Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set|||Participants|||Count of Participants
2642681|NCT01735175|Secondary|Incidence of Febrile Neutropenia (FN)|"FN was defined as an oral temperature ≥ 38.3°C while having an absolute neutrophil count (ANC) < 0.5 × 10^9 cells/L. Serious treatment-emergent adverse events (TEAEs) were reconciled with the fever and ANC results recorded in the patient diary and CRF and therefore only the serious TEAEs of FN (febrile neutropenia, neutropenic sepsis) were taken into account."|across all cycles (18 weeks)|Number of patients with at least one episode of febrile neutropenia by cycle and across all cycles (FAS set)|||Participants|||Count of Participants
2642682|NCT01735175|Primary|Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy|Mean duration of severe neutropenia, defined as number of consecutive days with ANC <0.5 × 10^9 cells/L (grade 4 neutropenia).|21 days (Cycle 1 of chemotherapy treatment)|FAS set = full analysis set; PP set = per protocol set|||days||Standard Deviation|Mean
2642683|NCT01734993|Secondary|Change From Baseline in CRP|Blood samples were collected for CRP, which is an acute phase reactant and a measure of inflammation. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.|||milligrams per liter (mg/L)||Standard Deviation|Mean
2642684|NCT01734993|Secondary|Change From Baseline in ESR|Blood samples were collected for ESR, which is an acute phase reactant and provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.|||mm/hr||Standard Deviation|Mean
2642685|NCT01734993|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity|"The Physician's Global Assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely."|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.|||mm||Standard Deviation|Mean
2642686|NCT01734993|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score|The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population, Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.|||Units on a scale||Standard Deviation|Mean
2642687|NCT01734993|Secondary|Change From Baseline in Patient's Assessment of Pain|Patient's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 mm=no pain to right end of the line 100 mm=unbearable pain. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety Population. Here, 'n' represents the number of participants available for assessment at a given time point.|||mm||Standard Deviation|Mean
2642688|NCT01734993|Secondary|Change From Baseline in PtGA of Disease Activity|PtGA of disease activity over the previous 24 hours using a 100 mm VAS where left end of the line 0 mm =no disease activity and right end of the line 100 mm =maximum disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.|||mm||Standard Deviation|Mean
2642689|NCT01734993|Secondary|Time to Concomitant Corticosteroid Dose Reduction|Time to corticosteroid dose reduction (days) = (Date of the first dose reduction of corticosteroid treatment - date of first drug intake of this extension study) + 1.|Baseline up to approximately 142 weeks|Safety population. Here, N (number of participants analyzed) represents the participants who had concomitant corticosteroid dose reduction.|||Days||Full Range|Median
2642690|NCT01734993|Secondary|Time to Concomitant Corticosteroid Discontinuation|Time to corticosteroid discontinuation = (End date of corticosteroid treatment - date of first drug intake of this extension study) + 1.|Baseline up to approximately 142 weeks|Safety population. Here N (number of participants analyzed) represents the participants who discontinued concomitant corticosteroids|||Days||Full Range|Median
2642691|NCT01734993|Secondary|Percentage of Participants With Concomitant Corticosteroid Dose Reduction||Baseline up to approximately 142 weeks|Safety population. Here, N (number of participants analyzed) represents the participants who received concomitant corticosteroids.|||Percentage of participants|||Number
2642692|NCT01734993|Secondary|Percentage of Participants With Concomitant Corticosteroid Discontinuation||Baseline up to approximately 142 weeks|Safety population. Here, N (number of participants analyzed) represents the participants who received concomitant corticosteroids.|||Percentage of participants|||Number
2642693|NCT01734993|Secondary|Percentage of Participants With Clinical Remission|Clinical remission defined as:DAS28-ESR score < 2.6 and/or SDAI score </= 3.3.DAS28 score is measure of subject's disease activity calculated using TJC [28 joints],SJC [28 joints],PtGA of disease activity [ VAS:0mm= no disease activity to 100 mm=maximum disease activity] and ESR (mm/hr). DAS28 was calculated as DAS28-ESR = 0.56*sqrt (TJC28) + 0.28*sqrt(SJC28) + 0.70* ln ESR + 0.014*PtGA of disease activity. DAS28-ESR score ranged from 0 to approximately 10, higher score indicating more severe disease activity. SDAI was calculated =[SJC (28 joints) + TJC (28 joints) + VAS PtGA + VAS physician global assessment of disease activity+CRP level(mg/dL)]. VAS assessments:0 mm=no disease activity to 100 mm=maximum disease activity. SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity.|Week 48, 108|Safety population. Here, N (number of participants analyzed) represents the number of participants evaluable for this outcome and ‘n’ represents the number of participants available for assessment at a given time point.|||Percentage of participants|||Number
2642694|NCT01734993|Secondary|Change From Baseline in SJC|For SJC, a total of 28 joints were assessed. The presence of a swollen joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 28 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.|||Swollen Joints||Standard Deviation|Mean
2642695|NCT01734993|Secondary|Change From Baseline in TJC|For TJC a total of 28 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 28 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.|||Tender Joints||Standard Deviation|Mean
2642696|NCT01734993|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score|The SDAI was calculated as (SJC [28 joints] + TJC [28 joints] + VAS ptGA + VAS physician global assessment of disease activity + C-reactive Protein (CRP) level in milligram/deciliter [mg/dL]). VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity. SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, N (number of participants analyzed) represents the number of participants evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.|||Units on a scale||Standard Deviation|Mean
2642706|NCT01734902|Secondary|Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞ )|AUC0-∞, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 extrapolated to infinity|Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.|Descriptive statistics is based on TS and statistical analysis is based on pharmacokinetic (PK) analysis set (PKS). (PKS includes all treated subjects with data for a primary endpoint and without any protocol violation relevant to the statistical evaluation of PK endpoints.)|||Picogram*hour/millilitre [pg*h/mL]||Geometric Coefficient of Variation|Geometric Mean
2642697|NCT01734993|Secondary|Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score|The DAS 28 ESR score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment (PtGA) of disease activity (visual analog scale [VAS]: 0 millimeter [mm] = no disease activity to 100 mm=maximum disease activity) and the erythrocyte sedimentation rate (ESR in millimeters per hour [mm/hr]). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt (SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity. A total possible score of 0 to approximately 10, with higher score indicating more severe disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.|Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)|Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.|||Units on a scale||Standard Deviation|Mean
2642698|NCT01734993|Primary|Percentage of Participants With Anti-TCZ Antibodies||Baseline up to approximately 142 weeks|Safety population|||Percentage of participants|||Number
2642699|NCT01734993|Primary|Percentage of Participants With Clinically Significant Laboratory Abnormalities|Criteria for laboratory tests clinically significant abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(< 0.8*lower limit of normal[LLN]); leucocytes (<0.6/greater than [>]1.5*upper limit of normal [ULN]); platelets (<0.5*LLN></0>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN></0>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN></0>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN></0>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN></0>1.1*ULN); urine RBCs, urine white blood cells (WBCs) (> or equal[=]20 high-powered field), urine bacteria >20 high-powered field. Overall percentage of participants with any clinically significant laboratory abnormality was reported.|Baseline up to approximately 142 weeks|Safety population|||Percentage of participants|||Number
2642700|NCT01734993|Primary|Percentage of Participants With Clinically Significant Physical Examinations and Vital Signs Abnormalities|Criteria for potentially clinically important (PCI) change in vital signs: heart rate value of less than (<) 40 beats per minute and value greater than (>) 150 beats per minute, systolic blood pressure (SBP) of < 80 or >210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of <40 or >130 mmHg, body temperature <32 or > 40 degrees Celsius, respiratory rate of <10 or > 50 breaths/minute and criteria for PCI change in physical examination: >/=10% increase or decrease of body weight in kilograms (kg).|Baseline up to approximately 142 weeks|Safety population|||Percentage of participants|||Number
2642701|NCT01734993|Primary|Percentage of Participants With AEs Leading to TCZ Discontinuation, Interruption, or Dose Modification|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Percentage of participants with AE causing drug discontinuation, interruption and increase or decrease in dose of drug was presented.|Baseline up to approximately 142 weeks|Safety Population|||Percentage of participants|||Number
2642702|NCT01734993|Primary|Percentage of Participants With AESIs Related to TCZ|AESI for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events. Percentage of participants with AESI related to the drug were presented. Causality of AESIs based on physician's discretion: certain (AE after drug intake, not explained by other drugs, reaction on DC, relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs). AESIs with causality of certain, probable/likely, and possible were considered TCZ related.|Baseline up to approximately 142 weeks|Safety population|||Percentage of participants|||Number
2642703|NCT01734993|Primary|Percentage of Participants With Adverse Events of Special Interest (AESIs)|Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events.|Baseline up to approximately 142 weeks|Safety population|||Percentage of participants|||Number
2642704|NCT01734993|Primary|Percentage of Participants With AEs and SAEs Related to TCZ|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs as well as non-serious AEs. Causality of AEs based on physician's discretion: certain (AE after drug intake, not explained by other drugs, reaction on drug cessation [DC], relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs). AEs with causality of certain, probable/likely, and possible were considered TCZ related.|Baseline up to approximately 142 weeks|Safety population|||Percentage of participants|||Number
2642705|NCT01734993|Primary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A SAE was any untoward medical occurrence that at any dose resulted in death, was life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, and congenital anomaly/birth defect. AEs included SAEs as well as non-serious AEs.|Baseline up to approximately 142 weeks|Safety population|||Percentage of participants|||Number
2642707|NCT01734902|Primary|Area Under the Concentration-time Curve of the Hyoscine Butylbromide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|AUC0-tz, area under the concentration-time curve of the hyoscine butylbromide in plasma over the time interval from 0 to the last quantifiable data point|Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.|Descriptive statistics is based on TS and statistical analysis is based on pharmacokinetic (PK) analysis set (PKS). (PKS includes all treated subjects with data for a primary endpoint and without any protocol violation relevant to the statistical evaluation of PK endpoints.)|||Picogram*hour/millilitre [pg*h/mL]||Geometric Coefficient of Variation|Geometric Mean
2642708|NCT01734902|Primary|Maximum Measured Concentration of the Hyoscine Butylbromide in Plasma (Cmax)|Cmax, maximum measured concentration of the hyoscine butylbromide in plasma.|Pharmacokinetic samples were collected pre dose at 2 hour (h) and at 0.5, 1, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8, 10, 14, 24 and 36 h after the drug administration.|Descriptive statistics is based on treated set (TS) and statistical analysis is based on pharmacokinetic (PK) analysis set (PKS). (PKS includes all treated subjects with data for a primary endpoint and without any protocol violation relevant to the statistical evaluation of PK endpoints.)|||Picogram/millilitre [pg/mL]||Geometric Coefficient of Variation|Geometric Mean
2642709|NCT01734889|Secondary|The Palatability Scores on Day 3 (Subjects 5 - < 18 Years)|Patients rated the palatability of the suspension. The following grading was applied: 5 (very good), 4 (good), 3 (neither good nor bad), 2 (bad) and 1 (very bad).|Day 3|Full analysis set: All subjects who received at least one dose of study drug and had at least taste or acceptability assessment.|||units on a scale||Full Range|Median
2642710|NCT01734889|Secondary|The Palatability Scores on Day 2 (Subjects 5 - < 18 Years)|Patients rated the palatability of the suspension. The following grading was applied: 5 (very good), 4 (good), 3 (neither good nor bad), 2 (bad) and 1 (very bad).|Day 2|Full analysis set: All subjects who received at least one dose of study drug and had at least taste or acceptability assessment.|||units on a scale||Full Range|Median
2642711|NCT01734889|Secondary|The Palatability Scores on Day 1 (Subjects 5 - < 18 Years)|Patients rated the palatability of the suspension. The following grading was applied: 5 (very good), 4 (good), 3 (neither good nor bad), 2 (bad) and 1 (very bad).|Day 1|Full analysis set: All subjects who received at least one dose of study drug and had at least taste or acceptability assessment.|||units on a scale||Full Range|Median
2642712|NCT01734889|Primary|The Acceptability Score for the Last Dose of the Suspension on Day 3 for Subjects < 5 Years|The parents of patients aged <5 years rated their child´s acceptability of the suspension. The following grading was applied: 5 (very well), 4 (well), 3 (neither well nor badly), 2 (badly) and 1 (very badly).|Day 3|Full analysis set: All subjects who received at least one dose of study drug and had at least one taste or acceptability assessments|||units on a scale||Full Range|Median
2642713|NCT01734889|Primary|The Taste Score for the Last Dose of the Suspension on Day 3 for Subjects 5 - <18 Years|Patients rated the taste of the suspension. The following grading was applied: 5 (very good taste), 4 (good taste), 3 (neither good nor bad taste), 2 (bad taste) and 1 (very bad taste).|Day 3|Full analysis set: All subjects who received at least one dose of study drug and had at least one taste or acceptability assessments|||units on a scale||Full Range|Median
2642714|NCT01734785|Secondary|Body Weight Change From Baseline After 24 Weeks of Double-blind Treatment|Change from baseline Body weight after 24 weeks of treatment with double-blind trial medication.|Baseline and 24 weeks|FAS (OC)|||kg||Standard Error|Least Squares Mean
2642715|NCT01734785|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline After 24 Weeks of Double-blind Treatment.|Change from baseline FPG (mmol/L) after 24 weeks of treatment with double-blind trial medication.|Baseline and 24 weeks|FAS (OC)|||mmol/L||Standard Error|Least Squares Mean
2642716|NCT01734785|Primary|HbA1c Change From Baseline After 24 Weeks Double-blind Randomized Treatment|Change from baseline in Glycated haemoglobin (HbA1c) [%] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term 'baseline' was not used to refer to measurements before the administration of open-label medication.|Baseline and 24 weeks|The full analysis set (FAS) consisted of all patients in the treated set (TS) who had a baseline HbA1c assessment and at least 1 on-treatment HbA1c assessment during the double-blind part of the trial. Observed Case (OC): In the OC analysis, values after the use of rescue medication were set to missing.|||Percentage of HbA1c||Standard Error|Least Squares Mean
2642717|NCT01734772|Primary|Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss)|Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).|47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours|Pharmacokinetic set: This subject set included all subjects in the TS who provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability and who had not vomiting at or before 2 times the median tmax,ss of the trial medications on PK study days of both trial parts.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2642718|NCT01734772|Primary|Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)|Area under the concentration-time curve of dabigatran etexilate in plasma at steady state over the uniform dosing interval τ (AUCτ,ss).|47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours|Pharmacokinetic set: This subject set included all subjects in the TS who provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability and who had not vomiting at or before 2 times the median tmax,ss of the trial medications on PK study days of both trial parts.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2642719|NCT01734746|Other Pre-specified|Number of Patients With False Negative Sentinel Nodes.||During surgery.||||participants|||Number
2642720|NCT01734746|Secondary|Anatomical Location(s) of the Sentinel Nodes.|The number of patients with only paraaortic/paracaval, only pelvic, and both paraaortic/paracaval and pelvic sentinel node locations.patients.|During surgery.||||participants|||Number
2642721|NCT01734746|Primary|Number of Patients (%) in Which Sentinel Node(s) Are Detected After Injection of Blue Dye and Tracer in the Ovarian Ligaments.||During surgery.|see Kleppe et al., J Nucl Med 2014; 55:1799–1804|||participants|||Number
2644696|NCT01717014|Secondary|Usability: Visibility|Visibility measured by surgeon usability questionnaire.|Operatively||||% of cases surgeon agree/strongly agree|||Number
2642722|NCT01734655|Primary|Correlation of the MEQ Subscales to the MAAS|The convergent validity of the MEQ was also assessed by calculating the pearson correlation between the MEQ subscales and the Mindful Attention Awareness Scale (MAAS). Correlations were run with and without the External Cues subscale since it was found not to be internally consistent. **Indicates correlation significant at the .01 level|V1||||correlation coefficients|||Number
2642723|NCT01734655|Primary|Convergent Validity of the MEQ Subscales Compared to the EI Hunger Subscale|The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory subscales of restraint, disinhibition and hunger by calculating the Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory Subscale of Hunger. Correlations were run with and without the External Cues subscale since it was found not to be internally consistent.|V1||||correlation coefficients|||Number
2642724|NCT01734655|Primary|Convergent Validity of the Mindful Eating Questionnaire Subscales to the Eating Inventory Disinhibition Subscale|The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory subscales by calculating the Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory Subscale of Disinhibition. Correlations were run with and without the External Cues subscale since it was found not to be internally consistent.|V1||||correlation coefficients|||Number
2642725|NCT01734655|Primary|Convergent Validity of the Mindful Eating Questionnaire Compared to the Eating Inventory (EI) Restraint Subscale|The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory (EI) subscales (restraint, disinhibition, hunger) by calculating Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory restraint subscale. Correlations were run with and without the External Cues subscale (ECS) since it was found not to be internally consistent.|V1|Pregnant women who were overweight or obese and 18-40 yrs of age.|||correlation coefficients|||Number
2642726|NCT01734655|Primary|To Determine the Internal Validity of Each of the MEQ's Subscales, we Calculated Cronbach's a|"Cronbach's alpha is a measure of internal consistency, that is, how closely related a set of items are as a group. It is considered to be a measure of scale reliability. Alpha coefficients generally range from 0 to 1, with a higher score indicating greater reliability of a scale. However, a high value for alpha does not imply that the measure is unidimensional. Technically speaking, Cronbach's alpha is not a statistical test - it is a coefficient of reliability (or consistency)."|V1|Pregnant women who were overweight or obese and 18-40 yrs of age.|||Ratio of Variance|||Number
2642727|NCT01734655|Primary|Test-Retest Reliability of the Mindful Eating Questionnaire (MEQ)|Participants were given the Mindful Eating Questionnaire (MEQ) at their screening visit and study visit in an effort to establish test-retest reliability.|SV and V1; minimum of 24 hours between visits, maximum of 5 months between visits||||test-retest coefficent|||Number
2642728|NCT01734551|Secondary|Bayley Scales of Infant and Toddler Development Third Edition|Scores obtained Bayley Scales of Infant and Toddler Development Third Edition in the developmental domains of motor, cognitive, and language. This tool for measures of motor, cognitive and language development is a series of standardized measurements and for each domain, the standardized scores have a mean of 100 and standard deviation of 15. Scores below 1 standard deviation (= or less than 84) is considered below normal. Scores above 1 standard deviation (over 115) represent higher than normal functioning in each domain The score for each domain (motor, cognitive, and language functioning) represents the full-scale score|1 year of life|The above number fo reach arm represents the number of subjects who came for follow-up evaluation.|||scores on a scale||Standard Deviation|Mean
2642729|NCT01734551|Secondary|Neurobehavioral Performance Summary Scores From the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)|The summary scores from the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) give a measure of infant neurobehavior in the following areas (score range): habituation (1-9), regulation (2.20-7.50), attention (1.29 -8.4), Handling (0 - 1), quality of movement (1.20 - 6.20), Non-optimal reflexes (0-12), Asymmetric reflexes (0-7), arousal (2.43 - 6.67), hypertonicity (0- 8), hypotonicity (0 - 5.0), excitability (0-11), lethargy (0 - 11.0). and stress/abstinence (0. - 0.57). A higher score for each item means a higher level of the construct. For example, a higher score for hypertonicity means the infant is more hypertonic and higher score on hypotonicity means the infant is more hypotonic. No cut-off score published for normal or abnormal behavioral performance. Reference: Lester BM et al. Summary Statistics of Neonatal Intensive Care Unit Network Neurobehavioral Scale Scores From the Maternal Lifestyle Study: A Quasinormative Sample, in Pediatrics 2004; 113,668.|5-10 days after treatment starts||||scores on a scale||Standard Error|Mean
2642730|NCT01734551|Primary|Duration of Treatment|Total number days of treatment|120 days||||days||Full Range|Median
2642731|NCT01734551|Primary|Finnegan Neonatal Abstinence Scoring System|Mean of total Finnegan Scores obtained every 3 hours on days 2, 7, and 14 following start of treatment; A score is a number representing the total score or sum from 21 items or symptoms or manifestations of opiate withdrawal in newborn infants. The total score ranges from 0 to 43. Reference: 1. Finnegan LP, Connaughton JF, Jr., Kron RE, et al. Neonatal abstinence syndrome: assessment and management. Addict Dis 1975;2(1-2):141-58. Although normal newborn may manifest mild symptoms that will give scores in the range of 0 to 7. A score of 8 consecutively obtained times 3 indicate that infant will benefit from treatment, in this study morphine or clonidine. A decrease in scores especially to less than 8 is suggestive of a good response to treatment.|14 days||||scores on a scale||Standard Deviation|Mean
2642732|NCT01734525|Primary|Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin|The main interest is to evaluate the ocurrence of candidemia in patients with negative 1,3 beta-D-glucan who discontinue anidulafungin|30 days||||Participants|||Count of Participants
2642733|NCT01734434|Secondary|Number of Infants Brought to Study Site During Infant Follow up (90 Days Post-delivery)|The number of infants who were brought by the maternal subjects to a study site for 90-day infant follow-up visit relative to the number of live birth deliveries.|Delivery to Day 90 post-delivery (Infant follow-up)|Analysis was performed on the FAS.|||participants|||Number
2642734|NCT01734434|Secondary|Number of Infants Born Live, Reported Sick and Brought to a Study or Non-study Health Care Facility Site.|The number of infants born live, reported sick and brought to a study or non-study health care facility site by the maternal subjects over the period of 90 days after delivery was calculated.|Delivery to Day 90 post-delivery (Infant follow-up)|Analysis was done on the FAS|||participants|||Number
2642736|NCT01734434|Primary|Percentage of Subjects Delivering at a Study Site.|The percentage of subjects who delivered at the study site relative to the number of enrolled subjects was calculated|Baseline until average of 24 weeks|Analysis was done on Full analysis set (FAS)-All subjects in the All Enrolled Set who provided data after enrollment related to delivery, logistics or medical outcomes.|||Percentages of subjects||95% Confidence Interval|Number
2642737|NCT01734395|Secondary|Change From Screening at Week 16 in Mini Mental State Exam Scores (MMSE)|MMSC is a brief 30-point questionnaire test that is used for the assessment of dementia patients' cognitive impairment. Evaluation of points are as: 24-30 = No cognitive impairment, 18-23 = Mild cognitive impairment, 0-17 = Severe cognitive impairment. Lower scores indicate worsening.|Baseline, Week 16|FAS was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria|||Units on a scale||Standard Deviation|Mean
2642738|NCT01734395|Primary|Change From Baseline at Week 16 in Burden Interview (BI) Scores|BI is designed to evaluate subjective stress dementia patients' caregivers experience in relation to caregiving. It has total 22 questions with 4 options each and the calculated scores are from 1 to 88 (0-20 = Little or no burden, 21-40 = Mild to moderate burden, 41-60 = Moderate to severe burden, 61-88 = Severe burden). Higher scores indicate worsening.|Baseline, Week 16|FAS was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria and received the study drug at least once and whose evaluation visit was performed at least once in addition to the visit at baseline.|||Units on a scale||Standard Deviation|Mean
2642739|NCT01734395|Primary|Change From Baseline at Week 16 in Attention Questionnaire Scores (AQS)|AQS evaluates the attention of participants with dementia and is designed for their caregivers to evaluate the participant's attention directly. It has 15 questions devised to be suitable for cultural characteristics of Korea through the standardization study considering education and gender/culture gap. Each question is scored from 0 to 2 (0=never, 1=occasionally, 2=usually). In questions 1 to 8, the lower participant attention ability rated the higher score (AQS1), In questions 9 to 15, the higher participant attention ability rated the higher score (AQS2). The total score is calculated by the formula: 16-AQS1+AQS2 and the range is from 0 to 30. Higher score means better attention ability of participant.|Baseline (Week 1 [Day 1]), Week 16|FAS (Full Analysis Set) was used for the analysis. The FAS population was defined as the participants who satisfied the inclusion/exclusion criteria and received the study drug at least once and whose evaluation visit was performed at least once in addition to the visit at baseline.|||Units on a scale||Standard Deviation|Mean
2642740|NCT01734382|Secondary|Change From Baseline in Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study|Participant's/Parent's global assessment of overall well-being was determined on a VAS (range = 0-100, left end of the line = very well, i.e., symptom-free and no arthritis disease activity; right end = very poor, i.e., maximum arthritis disease activity). Reported is the change from baseline in VAS score with a negative change from baseline indicating an improvement.|Baseline; Part 2: Q3W arm groups - Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 and 51; Q4W arm groups - Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40|All TCZ population, all participants who have received at least one dose of study drug. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||score on a scale||Standard Deviation|Mean
2642741|NCT01734382|Secondary|Baseline Participant's/Parent's Global Assessment of Overall Well-being Score in Part 2 of the Study|Participant's/parent's global assessment of overall well-being was determined on a VAS (range = 0-100, left end of the line = very well, i.e., symptom-free and no arthritis disease activity; right end = very poor, i.e., maximum arthritis disease activity).|Baseline of Part 2|All TCZ population, all participants who have received at least one dose of study drug.|||score on a scale||Standard Deviation|Mean
2642742|NCT01734382|Secondary|Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study|CHAQ- Disability Index consists of 30 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed, among a total of 30 items. Each question was rated on 4-point scale with range 0=no difficulty to 3=unable to do. To calculate overall score, participant must have a domain score in at least 6 of 8 domains. Scores were averaged to calculate CHAQ disability index, range is 0=no/minimal physical dysfunction)-3=very severe physical dysfunction, higher score indicates more disability. Negative change from baseline indicates an improvement.|Baseline; Part 2: Q3W arm groups - Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 and 51; Q4W arm groups - Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40|All TCZ population, all participants who have received at least one dose of study drug. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||score on a scale||Standard Deviation|Mean
2642743|NCT01734382|Secondary|Baseline Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2 of the Study|CHAQ- Disability Index consists of 30 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities-distributed, among a total of 30 items. Each question was rated on 4-point scale with range 0=no difficulty to 3=unable to do. To calculate overall score, participant must have a domain score in at least 6 of 8 domains. Scores were averaged to calculate CHAQ disability index, range is 0=no/minimal physical dysfunction)-3=very severe physical dysfunction, higher score indicates more disability.|Baseline of Part 2|All TCZ population, all participants who have received at least one dose of study drug.|||score on a scale||Standard Deviation|Mean
2642744|NCT01734382|Secondary|Serum TCZ Concentration in Part 2 of the Study||Part 2: Q3W arms: Pre-dose at Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms: Pre-dose at Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40|All TCZ population in Part 2, all participants who have received at least one dose of study drug in Part 2. Number analyzed is the number of participants with data available for analyses at the given timepoint.|||ug/mL||Standard Deviation|Mean
2642745|NCT01734382|Secondary|Number of Participants With Anti-TCZ Antibodies in Part 2 of the Study||Part 2: Up to Week 52|Safety population, all participants who have received at least one dose of study drug and who have at least one post-baseline assessment of safety.|||Participants|||Count of Participants
2642813|NCT01733368|Primary|Number of Responder Patients (Structural Remodelling)|Structural remodelling is defined as a reduction >15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant.|6 months after implant|Patients with the 6-month follow-up completed and echocardiographic measurements available|||Participants|||Count of Participants
2642814|NCT01733329|Secondary|Blood Loss||24 hours||||mL||Standard Deviation|Median
2642746|NCT01734382|Secondary|Erythrocyte Sedimentation Rate (ESR) in Part 2 of the Study||Part 2: Q3W arms: Pre-dose at Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms: Pre-dose at Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40|PD population, all participants who have received at least one dose of study drug and who have at least one post-baseline assessment of PD. Number analyzed is the number of participants with data available at the given timepoint.|||mm/h||Standard Deviation|Mean
2642747|NCT01734382|Secondary|C-reactive Protein (CRP) Concentration in Part 2 of the Study||Part 2: Q3W arms: Pre-dose at Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms: Pre-dose at Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40|Pharmacodynamic (PD) population, all participants who have received at least one dose of study drug and who have at least one post-baseline assessment of PD. Number analyzed is the number of participants with data available at the given timepoint.|||mg/L||Standard Deviation|Mean
2642748|NCT01734382|Secondary|Soluble IL-6 Receptor (sIL-6R) Protein Concentration in Part 2 of the Study||Part 2: Q3W arms: Pre-dose at Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms: Pre-dose at Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40|Pharmacodynamic (PD) population, all participants who have received at least one dose of study drug and who have at least one post-baseline assessment of PD. Number analyzed is the number of participants with data available at the given timepoint|||ngEq/mL||Standard Deviation|Mean
2642749|NCT01734382|Secondary|Serum Interleukin-6 (IL-6) Protein Concentration in Part 2 of the Study||Part 2: Q3W arms: Pre-dose at Baseline, Weeks 3, 6, 9, 12, 24, 36, 48 and 51; Q4W arms: Pre-dose at Baseline, Weeks 0, 4, 8, 12, 24, 36 and 40|Pharmacodynamic (PD) population, all participants who have received at least one dose of study drug and who have at least one post-baseline assessment of PD. Number analyzed is the number of participants with data available at the given timepoint.|||pg/mL||Standard Deviation|Mean
2642750|NCT01734382|Secondary|Number of Participants With at Least One Adverse Event|An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Part 1 - Baseline up to 24 weeks plus 12 weeks of safety follow up; Part 2 - Baseline up to 52 weeks plus 12 weeks of safety follow up|Safety population, all participants who have received at least one dose of study drug and who have at least one post-baseline assessment of safety.|||Participants|||Count of Participants
2642751|NCT01734382|Primary|Number of Participants With Fever Attributable to Systemic Juvenile Idiopathic Arthritis (sJIA) in Part 2 of the Study|Absence of fever at screening visit was defined as a temperature measurement < 38 degree centigrades (C). Presence of fever at each study visit was defined as a temperature measurement ≥ 38 C.|Part 2: Up to 52 weeks|All TCZ population, all participants who have received at least one dose of study drug.|||Participants|||Count of Participants
2642752|NCT01734382|Primary|Number of Participants With Juvenile Idiopathic Arthritis (JIA) Disease Flare as Determined by JIA Core Variables in Part 2 of the Study|JIA flare was defined as any 3 of the 6 core outcome variables worsening by at least 30% relative to baseline visit of Part 2, with no more than 1 of the remaining variables improving by more than 30%. For the number of joints with active arthritis or the number of joints with limitation of motion a minimum worsening of at least 2 joints had to be present. If the physician global assessment (PGA) or the parent/patient global assessment were used a minimum worsening of at least 2 units on a scale from 0 to 10 had be present. For erythrocyte sedimentation rate (ESR), a worsening of at least 30% was not considered if within normal ranges. The 6 core outcome variables: PGA of disease activity, parent/patient global assessment of overall well-being, number of joints with active arthritis, number of joints with limitation of movement, ESR (measure of acute phase reaction) and functional ability determined by Childhood Health Assessment Questionnaire (CHAQ) Disability Index.|Part 2: Up to 52 weeks|All TCZ population, all participants who have received at least one dose of study drug. Number of participants analyzed is the number of participants with data available for analyses.|||Participants|||Count of Participants
2642753|NCT01734382|Primary|Juvenile Arthritis Disease Activity Score (JADAS-71)|JADAS-71 has 4 components: Physician global assessment of disease activity on a visual analog scale (VAS) (range=0-10, left end of line=arthritis inactive, i.e., symptom-free and no arthritis symptoms; right end=arthritis very active), patient/parent global assessment of overall well-being on VAS (range=0-10, left end of line=very well, right end=very poor), normalized erythrocyte sedimentation rate (ESR) (range=0-10, If ESR is ≤20 mm/h, set to 0. If ≥120 mm/h, set to 10 mm/h. If > 20 mm/h and < 120 mm/h, apply formula: [ESR−20 mm/h]/10 mm/h), and a count of active arthritis (swelling present or pain present and limitation of motion) in 71 selected joints (range=0-71). JADAS-71 is sum of 4 component scores, range=0-101. A higher score=more arthritis disease activity. Data reported for up to Week 52 was collected in Part 2: Q3W arms: Baseline, Weeks 3,6,9,12,24,36,48 and 51; Q4W arms: Baseline, Weeks 0,4,8,12,24,36 and 40.|Part 2: Up to 52 weeks|All TCZ population, all participants who have received at least one dose of study drug. Number analyzed is the number of participants with data available at the given timepoint.|||score on a scale||Standard Deviation|Mean
2642754|NCT01734317|Secondary|Baseline (Visit 1) Pain Will be Measured Before Burn Assessment Visit 2-3, Pain Will be Measured (Pain BEFORE Dressing Removal, DURING Dressing Removal, AFTER Dressing Removal, 30 Min After Removal|"Pain will be measured by using the VAS scale, by placing a vertical mark across the 100 mm long horizontal line, from No pain to the left to Most intense pain imaginable to the right.~Baseline (Visit 1) Pain will be measured before burn assessment Visit 2-4, Pain will be measured (Pain BEFORE dressing removal, DURING dressing removal, AFTER dressing removal, 30 min after removal"|After 0/14/21 days treatment|No data collected||||||
2642755|NCT01734317|Primary|Number of Participants With Wound Healing|"Healing at day 14 pt 21. Healing was defined as ≥95% epithelialisation. The PictZar program will be used to analyze burn wound healing by tissue type. (The PictZar equipment for this analysis will be located at MHC HQ, however, the analysis will be performed by a clinician not affiliated with MHC.) Each subject was followed/assessed one time per week for a maximum of 3 weeks or until the burn was healed if that occured earlier."|14 days and 21 days||||participants|||Number
2642815|NCT01733329|Secondary|Postpartum Hemorrhage|"Defined as:~Estimated blood loss ≥1000 mL after cesarean delivery. A substantial fall in the haematocrit e.g. 10% The requirement for a blood transfusion"|24 HOURS||||percentage of patients|||Number
2642756|NCT01734239|Primary|Number of Participants Reporting Serious Adverse Experiences|A serious AE (SAE) is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention|Up to Day 28 postvaccination|The All Subjects as Treated population included all enrolled participants|||Number of participants|||Number
2642757|NCT01734239|Primary|Number of Participants Reporting an Injection-site or Systemic Adverse Experience That Was Reported by >=4 Participants|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an AE. Injection-site or systemic AEs that occurred in >=4 participants were reported for this endpoint.|Up to Day 14 postvaccination|The All Subjects as Treated population included all enrolled participants|||Number of participants|||Number
2642758|NCT01734239|Primary|Number of Participants With Elevated Body Temperature (>=37.6 °C Axillary / >=38.0 °C Oral or Equivalent)||Up to 5 days postvaccination|The All Subjects as Treated population included all enrolled participants|||Number of participants|||Number
2642759|NCT01734239|Primary|Percentage of Participants With >=2-fold Increase From Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine|Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A >=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults.|Day 28 postvaccination|The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range|||Percentage of participants||95% Confidence Interval|Number
2642760|NCT01734239|Primary|Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine|Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays|Prevaccination and Day 28 after vaccination|The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range|||ug/mL||95% Confidence Interval|Mean
2642761|NCT01734161|Primary|Incidence of Post-operative Nausea and/or Vomiting|The patient's self report of nausea and incidence of vomiting will be recorded intra-operatively, upon arrival to the PACU and at 1, 3, 6, 24, and 48 hours after surgery|48 hours||||Participants|||Count of Participants
2642762|NCT01733953|Secondary|Change From Baseline in Carotid Intima-Media Thickness at 6-Months||Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.|||mm||95% Confidence Interval|Mean
2642763|NCT01733953|Secondary|Change From Baseline in Augmentation Index at 6-Months||Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.|||P2/P1||95% Confidence Interval|Mean
2642764|NCT01733953|Secondary|Change From Baseline in Pulse Wave Velocity at 6-Months||Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.|||m/s||95% Confidence Interval|Mean
2642765|NCT01733953|Secondary|Change From Baseline in Carotid Artery Distensibility at 6-Months||Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.|||% distensibility||95% Confidence Interval|Mean
2642766|NCT01733953|Secondary|Change From Baseline in Carotid Artery Compliance at 6-Months|Carotid Artery Compliance is a measure of arterial stiffness. Higher arterial stiffness places persons at higher risk for CVD.|Baseline and 6-Months|Discrepant sample sizes are due to lack of reliability of measures. If measures were unreliable they were excluded.|||mm/mmHg x 10^-3||95% Confidence Interval|Mean
2642767|NCT01733953|Primary|Change From Baseline in Brachial Artery Flow-Mediated Dilation at 6-months||Baseline and 6-Months|Physician withdrawals, loss to follow-up, drug compliance <70%, unrelated injury, and self-withdrawal reduced number analyzed. Also, participant movement during FMD assessment and/or poor ultrasound image quality due to difficult brachial artery anatomy or poor circulation led to some unusable data and thus lowered the analyzable sample size.|||percentage change||95% Confidence Interval|Mean
2642768|NCT01733758|Secondary|Time to Study Withdrawal for Any Reason|Time to withdrawal was calculated as the number of days between the date of first dose and the date of withdrawal plus 1. Time to withdrawal was summarized by visit.|Baseline through Week 52|Intent-to-Treat Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline assessment and at least one post-Baseline assessment (scheduled or unscheduled) of the primary endpoint, HbA1c.|||Weeks||95% Confidence Interval|Median
2642769|NCT01733758|Secondary|Time to Study Withdrawal Due to Hyperglycemia|Participants who experienced persistent hyperglycemia after uptitration were to be withdrawn from the study. Hyperglycemia is defined as a fasting plasma glucose (FPG) ≥280 mg/dL (≥15.5 mmol/L) from ≥Week 2 to <Week 4, ≥250 mg/dL (≥13.9 mmol/L) from ≥Week 4 to <Week 12, or ≥230 mg/dL (≥12.8 mmol/L) from ≥Week 12 to <Week 52, confirmed a second evaluation within 7 days.|Baseline through Week 52|Intent-to-Treat Population: all randomized par. who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Par. who did not conform to the protocol-defined criteria of persistent hyperglycemia with respect to FPG values defined above were not included in this analysis.|||Weeks||95% Confidence Interval|Median
2642770|NCT01733758|Secondary|Change From Baseline in Body Weight at Week 52|The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 52 minus the value at Baseline.|Baseline and Week 52|Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued before Week 52 from study treatment were not included in the analysis. No missing data were imputed.|||Kilograms (kg)||Standard Deviation|Mean
2644697|NCT01717014|Primary|Distal Margins|The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum.|Operative||||participants|||Number
2642771|NCT01733758|Secondary|Change From Baseline in Body Weight at Week 24|The Baseline body weight value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the body weight value at Week 24 minus the value at Baseline. Participants who discontinued from the study treatment before Week 24 had their last non-missing weight carried forward for the summary, unless the value is past 14 days after the last dose of study drug.|Baseline and Week 24|Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.|||Kilograms (kg)||Standard Deviation|Mean
2642772|NCT01733758|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52|FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the FPG value at Week 52 minus the FPG value at Baseline.|Baseline and Week 52|Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in this analysis. No missing data were imputed.|||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2642773|NCT01733758|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|FPG is an indicator of efficacy. The Baseline FPG value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the FPG value at Week 24 minus the FPG value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline FPG observation carried forward for the summary unless the value was 14 days past the last dose of study drug.|Baseline and Week 24|Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.|||Milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2642774|NCT01733758|Secondary|Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%.|Week 52|Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in the analysis. No missing data were imputed.|||Percentage of participants|||Number
2642775|NCT01733758|Secondary|Percentage of Participants Achieving Clinically Meaningful Levels of HbA1c (i.e., the Percentage of Participants Achieving Treatment Goal of <6.5% and <7.0%) at Week 24|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. Clinically meaningful levels of response in HbA1c are defined as <6.5% and <7.0%. Participants who discontinued the study before Week 24 had their last post-Baseline HbA1c value carried forwrad for the summary unless the value was past 14 days after the last dose of study drug.|Week 24|Intent-to-Treat (Last Observation Carried Forward) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment.|||Percentage of participants|||Number
2642776|NCT01733758|Secondary|Change From Baseline in HbA1c at Week 52|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3- month period. The Baseline HbA1c value is defined as the last non-missing value on or before the start of treatment. Change from Baseline was calculated as the value at Week 52 minus the value at Baseline.|Baseline and Week 52|Intent-to-Treat (Observed Case) Population: all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment. Participants who discontinued from study treatment before Week 52 were not included in the analysis. No missing data were imputed.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
2642777|NCT01733758|Primary|Mean HbA1c at Baseline, Week 24, and Change From Baseline at Week 24|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c value carried forward for the summary, unless the value was past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group; descriptive statistics comparing albiglutide and liraglutide were exploratory endpoints.|Baseline and Week 24|Intent-to-Treat Population (Last Observation Carried Forward): all randomized participants who received at least 1 dose of study treatment and had a Baseline assessment and at least 1 post-Baseline assessment of HbA1c on or before Week 24 provided it was not past more than 14 days after the last dose of study drug intake.|||Percentage of HbA1c in the blood||Standard Deviation|Mean
2642778|NCT01733758|Primary|Model-adjusted Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3 month period. The Baseline HbA1c value is defined as the last nonmissing value before the start of treatment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. Based on analysis of covariance (ANCOVA): Change at Week 24 = treatment (placebo, albiglutide 30 mg, albiglutide 50 mg) + Baseline HbA1c + prior diabetes therapy + age category (<65 years versus ≥65 years). Participants who discontinued from study treatment before Week 24 had their last post-Baseline HbA1c carried forward for the analysis unless the value is past 14 days after the last dose of study drug. The open-label liraglutide group was a reference group and not included in the primary endpoint analysis model. Descriptive summary statistics are provided as a separate outcome measure.|Baseline and Week 24|Intent-to-Treat Population (Last Observation Carried Forward): all randomized participants who received at least 1 dose of study treatment and had a Baseline HbA1c assessment and at least one post-Baseline HbA1c assessment of HbA1c.|||Percentage of HbA1c in the blood||Standard Error|Least Squares Mean
2642972|NCT01732549|Secondary|Time to Further Anticancer Treatment for Prostate Cancer|Time from randomisation to further treatment for prostate cancer|Every 3 months after study treatment stop until further anticancer therapy for prostate cancer (approximately up to 2.5 years)|ITT population|||weeks||90% Confidence Interval|Median
2642779|NCT01733745|Secondary|Dry Eye Ocular Surface Disease Index (OSDI) Questionnaire Responses|The Dry Eye OSDI Questionnaire is a 12-question validated questionnaire [resultant overall 0-100 score, with 0 being none of the time (best) and 100 being all of the time (worst)] that measures ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.|Baseline, Month 1, Month 2, Month 3|This reporting group includes all subjects who were enrolled and received at least one of the study treatments.|||units on a scale|Eyes|Standard Deviation|Mean
2642780|NCT01733745|Secondary|Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Responses|The Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire is a 16-question validated questionnaire (resultant overall score 0-28, with 0 being best and 28 being worst) that measures the frequency and severity of dry eye symptoms. The SPEED questionnaire was completed by the patient with no assistance from the office staff, physician, or anyone else. Both eyes contributed to the mean.|Baseline, Month 1, Month 2, Month 3|This reporting group includes all subjects who were enrolled and received at least one of the study treatments.|||units on a scale|Eyes|Standard Deviation|Mean
2642781|NCT01733745|Primary|Number of Meibomian Glands Yielding Liquid Secretion (MGLYS)|Meibomian gland functionality was evaluated by the investigator using the Meibomian Gland Evaluator (MGE), a handheld instrument that provides a standardized method for applying consistent, gentle pressure to the outer skin of the lower eyelid. The total number of meibomian gland orificies evidencing liquid secretion during expression with the MGE, in both eyes, was recorded. A lower number of functioning meibomian glands may contribute to dry eye syndrome.|Baseline, Month 1, Month 2, Month 3|This reporting group includes all subjects who were enrolled and received at least one of the study treatments.|||functioning glands|Eyes|Standard Deviation|Mean
2642782|NCT01733732|Secondary|Mean Change From Baseline in Intraocular Pressure (IOP) by Visit|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline-adjusted values were tabulated. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."|||mmHg|eyes|Standard Deviation|Mean
2642783|NCT01733732|Secondary|Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit|Dry eye status was assessed using the Schirmer's test. The investigator placed a paper strip on the eye under the lower lid for a specified time period. The length of the strip wetted by the tears was measured in millimeters. Baseline-adjusted values were tabulated; a positive number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."|||millimeters|eyes|Standard Deviation|Mean
2642784|NCT01733732|Secondary|Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30|Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. Total RNA was isolated. The number of cells expressing the inflammatory marker (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as score at Day 30 minus score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean.|Baseline (Day 0), Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||percentage of cells||Standard Deviation|Mean
2642785|NCT01733732|Secondary|Mean Change From Baseline for % HLA-DR Inflammatory Biomarker Expression at Day 30|Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. The number of cells expressing the inflammatory marker HLA-DR (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as HLA-DR score at Day 30 minus HLA-DR score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean.|Baseline (Day 0), Day 30|This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit.|||percentage of cells|eyes|Standard Deviation|Mean
2642786|NCT01733732|Secondary|Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30|A tear sample was collected and cytokine (small proteins) levels were analyzed using a High Sensitive Human Cytokine MilliPlex kit and measured in picograms/milliliter (pg/mL). Baseline-adjusted scores were tabulated; a negative number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||pg/mL||Standard Deviation|Mean
2642787|NCT01733732|Secondary|Mean Change From Baseline in Ocular Surface Staining by Visit|Ocular surface staining (damage to the ocular surface) was assessed using non-toxic ophthalmic dye during slit-lamp review. Corneal and conjunctival staining were graded as per the National Eye Institute (NEI) pictorial scale. The ocular staining score ranges from 0 to 3. The lower the score, the less signs of dry eye disease a patient exhibits. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.|||units on a scale|eyes|Standard Deviation|Mean
2642816|NCT01733329|Secondary|Uterine Atony|"Uterine atony is defined as failure of the uterus to contract adequately following delivery. Recognition of a soft, boggy uterus in the setting of excessive postpartum bleeding can alert the attendant to atony and should trigger a series of interventions aimed at achieving tonic sustained uterine contraction."|24 hours||||percentage of participants|||Number
2644698|NCT01717014|Primary|Staple Line|The surgeons ability to achieve a staple line at the desired level of the rectum.|Operative||||participants|||Number
2642788|NCT01733732|Secondary|Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit|TMH (the distance between the line of reflection along the top of the tear prism to the edge of the eyelid) was measured in millimeters using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."|||millimeters|eyes|Standard Deviation|Mean
2642789|NCT01733732|Secondary|Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit|NIKBUT (time required for dry spots to appear on the surface of the eye after blinking) was measured in seconds using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."|||seconds|eyes|Standard Deviation|Mean
2642790|NCT01733732|Secondary|Meibomian Gland Expression|Meibomian gland expression (ie, pressing on the meibomian glands to excrete oil) was performed by the investigator during undilated slit lamp examination and graded on a 4-point scale where 0=normal, clear oil expressed and 3=congealed or no material expressed. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."|||units on a scale|eyes|Standard Deviation|Mean
2642791|NCT01733732|Secondary|Percentage of Eyes With Normal Slit-lamp Assessment|An undilated slit lamp exam was performed to examine the regions of the eye: orbit/lids, conjunctiva, cornea, anterior chamber, iris and lens. Each region was graded normal or abnormal. The percentage of eyes with normal assessments by region is reported. Each eye was assessed individually. Both eyes were included in the tabulation.|Baseline (Day 0), Day 14, Day 30|This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.|||percentage of eyes|eyes||Number
2642792|NCT01733732|Secondary|Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit|BCVA (with spectacles or other visual corrective devices) was determined using an ETDRS or modified EDTRS chart and measured in logMAR (logarithm of the minimum angle of resolution). Baseline-adjusted logMAR values were tabulated; a negative number change from baseline indicates better visual acuity. Each eye was assessed individually. Both eyes contributed to the mean.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively."|||LogMAR||Standard Deviation|Mean
2642793|NCT01733732|Primary|Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit|The Ocular Surface Disease Index (OSDI) is a 12-question validated questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates a perceived improvement in ocular comfort.|Baseline (Day 0), Day 14, Day 30|"This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
2642794|NCT01733680|Secondary|The Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)|"BRIEF-A is a 75 item self report questionnaire that measures behavior and executive function. For each item the subject is asked during the past month, how often has each of the following behaviors been a problem?: The choices are N (never), S (sometimes), O (Often). Total score for the Global Executive Composite used. Raw data were transformed into t-scores, which are standardized scores that indicate the number of standard deviations away from the mean. A T-score of 50 is equal to the mean. Values less than 65 indicate executive function is not a problem and values greater than 65 indicate executive function is often a problem."|8 weeks|Statistical analysis of the outcome data was not done due to the small N of each group|||Global Executive Composite T Score||90% Confidence Interval|Mean
2642795|NCT01733680|Secondary|AISRS, Adult ADHD Investigator Rating Scale|An 18 item clinician administered questionnaire to evaluate ADHD in adults. Responses to questions were 0-None, 1-Mild, 2-Moderate, 3-Severe. A decrease of 30% in the total score would be considered improvement. Total score range is 0-54. A lower score indicates improvement in symptoms. A score of 24 or more indicates symptomatic ADHD.|8 weeks|Statistical analysis of the outcome data was not done due to the small N.|||Total score||Full Range|Mean
2642796|NCT01733680|Primary|Improvement in CGI|CGI Improvement scale: 1=very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; 7=Very much worse|8 weeks|There was no statistical analysis done due to the small number of participants in the study|||Units on a scale||Full Range|Mean
2642797|NCT01733628|Secondary|"Number of Participants With White Coat AHT With 24 Hours Ambulatory BP Measure"|"The incidence of white coat arterial hypertension (AHT) was evaluated comparing each of the measurements with the measurement that was made in the hospital. Ambulatory Blood Pressure Monitoring (ABPM) is when the blood pressure is being measured as patient moves around, living her normal daily life.~White Coat Hypertension is a phenomenon in which people exhibit a blood pressure level above the normal range, in a clinical setting, though they do not exhibit it in other settings."|Baseline, cycle 1, cycle 2, and cycle 3, up to 9 weeks||||Participants|||Count of Participants
2642798|NCT01733628|Secondary|"Number of Participants With White Coat AHT While at Home"|"The incidence of white coat arterial hypertension (AHT) was evaluated comparing each of the measurements in medical attention (in a doctor office) with the measurement that was made at home (without a doctor).~White Coat Hypertension is a phenomenon in which people exhibit a blood pressure level above the normal range, in a clinical setting, though they do not exhibit it in other settings."|Cycle 1, cycle 2, and cycle 3, up to 9 weeks||||Participants|||Count of Participants
2642799|NCT01733628|Primary|Progression Free Survival (PFS)|The PFS is the time from the patient receiving the first dose of chemotherapy for advanced disease to the date of progression, the administration of a new antineoplastic treatment that does not contain bevacizumab or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 3 years|There were 30 patients who were not included in Population per Protocol because of the following: 6 patients didn’t fulfil inclusion and exclusion criteria, 8 patients didn’t received Bevacizumab, 16 patients didn’t have Holter assessment performed at baseline and/or at any other study visit|||Months||Standard Deviation|Mean
2642800|NCT01733628|Primary|Number of Participants With or Without Blood Pressure Increase as a Predictor of Progression Free Survival (PFS)|The incidence of hypertension was studied during treatment with bevacizumab combined with chemotherapy. A Cox regression analysis was performed, entering as a dependent variable the PFS and as independent variable the Arterial Hypertension (AHT) (yes/no). AHT is introduced in the model of Cox as a time-dependent variable since its situation can change as length of the study. The date on which the AHT changes (passes from normotensive to hypertensive).|Up to 3 years|There were 30 patients who were not included in Population per Protocol because of the following: 6 patients didn’t fulfil inclusion and exclusion criteria, 8 patients didn’t received Bevacizumab, 16 patients didn’t have Holter assessment performed at baseline and/or at any other study visit.|||Participants|||Count of Participants
2642801|NCT01733472|Other Pre-specified|Time Hrs Until the Patient Meets the Discharge Criteria From PACU|Hours until the patient meets the discharge criteria from PACU will be monitored every 15 min from teh time the patient arrives to PACU until he/she meets the discharge criteria|12 hrs|Two patients in the RA group were excluded because of the conversion to general anaesthesia.|||hours||Inter-Quartile Range|Median
2642802|NCT01733472|Secondary|Post Operative Pain|Pain will be monitored using a Visual Analogue Scale. Pain will be monitored with the patient in four different positions. VAS 100 mm used for assessment of pain (0 = no pain, 100 = worst imaginable pain). At each time and position the median VAS-pain score was reported (generally the distribution of pain scores are not normally distributed and hence median value was used)|from end of surgey until 48 hrs later|Two patients in the RA group were excluded because of the conversion to general anaesthesia.|||score on a scale||Inter-Quartile Range|Median
2642803|NCT01733472|Primary|Length of Hospital Stay|Time from the end of surgery until the patients meets the discharge criteria will be evaluated. Discharge criteria: able to get in and out of bed, Able to get dressed. Able to sit down in a chair and get up again. Able to walk 50 meters wit/without crutches. Able to flex knee 70 degrees. Able to walk stairs. Pain manageable with oral analgesics. Acceptance to be discharged|Up to 4 days after surgery|Two patients in the RA group were excluded because of the conversion to general anaesthesia.|||hours||Inter-Quartile Range|Median
2642804|NCT01733407|Secondary|1-deoxy-sphingosine|Plasma levels of the deoxysphingoid lipid 1-deoxy-sphingosine measured by liquid chromatography/mass spectrometry after hydrolyzing the N-acyl and O-linked headgroups|48 weeks||||micromole per liter||Standard Deviation|Mean
2642805|NCT01733407|Secondary|1-deoxy-sphinganine|Plasma levels of the deoxysphingoid lipid 1-deoxy-sphinganine measured by liquid chromatography/mass spectrometry after hydrolyzing the N-acyl and O-linked headgroups|48 Weeks||||micromole per liter||Standard Deviation|Mean
2642806|NCT01733407|Secondary|Nerve Conduction Testing|Evaluates the functioning of electrical conduction of the motor and sensory nerves of the human body.|48 Weeks||||microvolts||Standard Error|Mean
2642807|NCT01733407|Secondary|Autonomic Function Testing (AFT) Composite Autonomic Severity Score (CASS)|Autonomic Function Testing (AFT) tests the effectiveness of your autonomic nervous system which regulates important functions such as blood pressure, heart rate, and respiration. AFT results are quantified using the composite autonomic severity score scale (CASS) which is a scale from 0 to 10 that is the sum of three sub scores (cardiovagal, adrenergic, and sudomotor). Cardiovagal is scored from 0 to 3, sudomotor is scored from 0 to 3, and adrenergic is scored from 0 to 4. The tests include deep breathing, Valsalva maneuver, head-up tilt, and a sweat test. The three subscores are then summed. This total represents the CASS which classifies autonomic function as normal functioning (total score 0), mild (total score 1-3), moderate (total score 4-6), or severe (total score 7-10).|48 Weeks||||scores on a scale||Standard Deviation|Mean
2642808|NCT01733407|Secondary|Intraepidermal Nerve Fiber Density (IENFD)|Counts of nerve fibers per unit area in skin biopsies|48 Weeks||||nerve fibers per micrometer^2||Standard Deviation|Mean
2642809|NCT01733407|Primary|Charcot Marie Tooth Neuropathy Score|The Charcot Marie Tooth Neuropathy Score (CMTNS) is a 0 to 36 point composite scoring assessment that is used to measure disease severity in Charcot Marie Tooth Neuropathy and other sensory and motor neuropathies. The CMTNS is composed of 9 items that evaluate functions related to disease progression. These 9 parameters include reviewing sensory symptoms, motor symptoms (arms and legs), pinprick sensibility, vibration, leg strength, arm strength, and nerve conduction tests. Each item is scored from 0 to 4, with the lower scores representing less severe symptoms and higher scores representing more severe symptoms.The 9 individual item scores are then totaled to provide a global measure of disease severity. For example the lowest possible total score is 0 which represents an asymptomatic individual and the highest score possible is a 36 which represents an individual with severe disease progression. There are sub scores that can be assessed but sub scores were not utilized in this study|48 Weeks||||scores on a scale||Standard Deviation|Mean
2642810|NCT01733368|Secondary|Number of Responder Patients With Conventional Left Ventricular Pacing Vector|"Response is defined as a reduction >15% in LVESV, measured 6 months after implant.~Conventional pacing vectors are the pacing vectors available both in the Quartet LV quadripolar lead and in the conventional bipolar leads."|6 months after implant|Patients with the 6-month follow-up completed, echocardiographic measurements available and programmed with a conventional pacing vector|||Participants|||Count of Participants
2642811|NCT01733368|Secondary|Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector|"Response is defined as a reduction >15% in LVESV, measured 6 months after implant.~Non-conventional pacing vectors are the pacing vectors exclusive to the Quartet LV quadripolar lead, not available in the conventional bipolar leads."|6 months after implant|Patients with the 6-month follow-up completed, echocardiographic measurements available and programmed with non-conventional LV pacing vector|||Participants|||Count of Participants
2642817|NCT01733329|Primary|Need for Additional Uterotonic Medications|The surgeon requested additional uterotonic agents on the basis of the clinical findings during surgery (e.g. uterine atony or blood loss of at least 1000 mL) Additional oxytocin was considered additional oxytocic intervention for purposes of data analysis.|24 hours||||percentage of participants|||Number
2642818|NCT01733316|Secondary|Halitosis Substudy: Expired Air DMS Concentrations|"Participants who reported halitosis (bad breath) as a side effect while receiving Cystagon® were asked to participate in a substudy to investigate the concentration of DMS in expired air after the administration of study medication. To assess halitosis during study medication treatment, the steady state PK samples of cysteamine and DMS were collected over a 6 hour period when Cystagon® was administered and over a 12 hour period when RP103 was administered."|While taking Cystagon® (Month 1, 2 or 3): Within 15 minutes prior to morning dose 30 min post-dose, 2, 3, 4 and 6 hours post-dose. While taking RP103 (Month 4, 5, or 7): Within 15 min. prior to morning dose. 1, 2, 3, 4, 5, 6, 8, 10, 12 hours post dose|PK Analysis Set: All participants who received at least one dose of RP103 and had available PK data at given timepoint.|||nmol/L||Standard Deviation|Mean
2642819|NCT01733316|Secondary|Area Under the Plasma Concentration Time Curve From Time Point 0 Through the Last Measurable Point (AUC0-t) for Plasma Cysteamine|"Participants who reported halitosis (bad breath) as a side effect while receiving Cystagon® were asked to participate in a substudy to investigate the concentration of DMS in expired air after the administration of study medication. To assess halitosis during study medication treatment, the steady state PK samples of cysteamine and DMS were collected over a 6 hour period when Cystagon® was administered and over a 12 hour period when RP103 was administered."|While taking Cystagon® (Month 1, 2 or 3): Within 15 minutes prior to morning dose, 30 minutes post-dose, 1, 2, 4 and 6 hours post-dose. While taking RP103 (Month 5, 6, or 7): 30 minutes after morning dose and 1, 2, 3, 4, 6, 8, 10, 12 hours post-dose|PK Analysis Set: All participants who received at least one dose of RP103 and had available PK data at given timepoint.|||hr*mg/L||Standard Deviation|Mean
2642820|NCT01733316|Secondary|Halitosis Substudy: Time to Cmax (Tmax) for Plasma Cysteamine|"Participants who reported halitosis (bad breath) as a side effect while receiving Cystagon® were asked to participate in a substudy to investigate the concentration of DMS in expired air after the administration of study medication. To assess halitosis during study medication treatment, the steady state PK samples of cysteamine and DMS were collected over a 6 hour period when Cystagon® was administered and over a 12 hour period when RP103 was administered."|While taking Cystagon® (Month 1, 2 or 3): Within 15 minutes prior to morning dose, 30 minutes post-dose, 1, 2, 4 and 6 hours post-dose. While taking RP103 (Month 5, 6, or 7): 30 minutes after morning dose and 1, 2, 3, 4, 6, 8, 10, 12 hours post-dose|PK Analysis Set: All participants who received at least one dose of RP103 and had available PK data at given timepoint.|||hour||Standard Deviation|Mean
2642821|NCT01733316|Secondary|Halitosis Substudy: Maximum Plasma Concentration (Cmax) for Plasma Cysteamine|"Participants who reported halitosis (bad breath) as a side effect while receiving Cystagon® were asked to participate in a substudy to investigate the concentration of dimethylsulfide (DMS) in expired air after the administration of study medication. To assess halitosis during study medication treatment, the steady state pharmacokinetic (PK) samples of cysteamine and DMS were collected over a 6 hour period when Cystagon® was administered and over a 12 hour period when RP103 was administered."|While taking Cystagon® (Month 1, 2 or 3): Within 15 minutes prior to morning dose, 30 minutes post-dose, 1, 2, 4 and 6 hours post-dose. While taking RP103 (Month 5, 6, or 7): 30 minutes after morning dose and 1, 2, 3, 4, 6, 8, 10, 12 hours post-dose|PK Analysis Set: All participants who received at least one dose of RP103 and had available PK data at given timepoint.|||mg/L||Standard Deviation|Mean
2642822|NCT01733316|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs|AE: any untoward medical occurrence that does not necessarily have a causal relationship with study drug. SAE: any untoward medical occurrence that at any dose: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; or is medically significant, and though not included in the above list, is an important medical event, according to the Investigator. Treatment-emergent adverse events (TEAEs) occurred after first dose of study drug. Clinically significant abnormalities in laboratory values (hematology, blood chemistry, urinalysis), electrocardiograms (ECGs), vital signs, and physical examinations were to be reported as adverse events and so are included in this summary of TEAEs|From first dose of study drug to 7 days after last dose. Median duration of exposure was 91 days (range 82-108) for Cystagon® phase, 119 days (range 98-137) for the RP103 phase, and 861 days (range 30 - 1350) during the long-term RP-103 phase.|"Safety Analysis Set: all participants who received at least 1 dose of study drug (RP103). The row At least 1 TEAE includes both serious and non-serious AEs."|||Participants|||Count of Participants
2642823|NCT01733316|Primary|Average Difference Between Morning and Non-Morning Log White Blood Cell (WBC) Cystine Values|The primary analysis of WBC cystine was performed using the natural log transformed WBC cystine level; the log transformation is a normalizing transformation. For each participant, the difference between the morning and corresponding non-morning log WBC cystine value (non-morning minus morning) at each monthly visit during the Cystagon® phase (Months 1, 2, and 3) was computed and these differences were averaged. The average difference between morning and non-morning log WBC cystine value was similarly computed for each participant during the RP103 phase (Months 5, 6, and 7). The primary analysis compared within-subject pairs (Cystagon® phase paired with RP103 phase) of non-morning minus morning average differences of log WBC cystine level.|While taking Cystagon® (Months 1, 2, 3): within 15 minutes pre-morning (AM) and pre-non AM dose. During 3 months of RP103 (Months 5, 6, 7): 30 minutes post-AM and post-evening (PM) dose.|Pharmacodynamic (PD) Analysis Set: All participants who received at least one treatment of Cystagon® and RP103 and who had at least one WBC cystine level recorded after each of Cystagon® treatment and RP103 treatment. Only participants with an average difference during both the Cystagon® and RP103 phases were included.|||log [nmol ½ cystine/mg protein]||Standard Deviation|Mean
2642824|NCT01733277|Other Pre-specified|Correlation Between the Presence of Neuropathic Pain and Biological Marker of Inflammation (CRP)||Baseline||||mg/L||Standard Deviation|Mean
2642861|NCT01732835|Secondary|LV Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||g||Standard Deviation|Mean
2642825|NCT01733277|Secondary|Variation in the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Scores (Total, Pain, Function, Stiffness) and the Presence or Absence of Neuropathic Pain|The WOMAC measures pain (score range 0-20), stiffness (score range 0-8), and functional limitation (score range 0-68) for a Total (cumulative score range 0-96) where the higher the score the worst the pain.|Baseline||||units on a scale||Standard Deviation|Mean
2642826|NCT01733277|Primary|Osteoarthritis Structural Changes Assessed by Quantitative Magnetic Resonance Imaging With and Without Neuropathic Pain||Baseline|Number of participant analyzed Per-protocol|||participants|||Number
2642827|NCT01733238|Secondary|Progression-free Survival|The time from Cycle 1 Day 1 until the date of lymphoma progression or death from any cause, or to the last date at which progression status was adequately assessed for censored observation|39 months|All subjects who received at least 1 dose of PNT2258|||months||95% Confidence Interval|Median
2642828|NCT01733238|Primary|Overall Response Rate|Subjects who had a best response of complete response or partial response as assessed by the investigator|39 months|All subjects who received at least 1 dose of PNT2258|||percentage of participants||95% Confidence Interval|Number
2642829|NCT01733212|Primary|Occurrence of Intra-operative and Post-operative Vomiting|Participants who had intra-operative and post-operative vomiting were identified and compared between the two groups.|During surgery (1 hour) and thru 72 hours after surgery|Number of participants who had vomiting in each group is compared to the other group using Chi square test|||Participants|||Count of Participants
2642830|NCT01733121|Secondary|Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6|Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).|Week 6|Intent to Treat (ITT) analysis set (all subjects in the safety analysis set with an evaluable, blinded, central video raters’ AIMS dyskinesia total score change from baseline value at one or more scheduled assessment times during the double-blind treatment period)|||units on a scale||95% Confidence Interval|Least Squares Mean
2642831|NCT01733121|Secondary|AIMS Dyskinesia Total Score Change From Baseline at Week 6|The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.|Week 6|Intent to Treat (ITT) analysis set (all subjects in the safety analysis set with an evaluable, blinded, central video raters' AIMS dyskinesia total score change from baseline value at one or more scheduled assessment times during the double-blind treatment period)|||units on a scale||95% Confidence Interval|Least Squares Mean
2642832|NCT01733121|Secondary|Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6|Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).|Week 6|Per protocol analysis set (subjects in the ITT analysis set that had an evaluable, blinded, central video raters' AIMS dyskinesia total score change from baseline value at Week 6, had a quantifiable NBI-98782 plasma concentration at Week 6 [for subjects in the NBI-98854 group], and had no efficacy-related important protocol deviations)|||units on a scale||95% Confidence Interval|Least Squares Mean
2642833|NCT01733121|Primary|Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6|The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.|Baseline and Week 6|Per protocol analysis set (subjects in the ITT analysis set that had an evaluable, blinded, central video raters’ AIMS dyskinesia total score change from baseline value at Week 6, had a quantifiable NBI-98782 plasma concentration at Week 6 [for subjects in the NBI-98854 group], and had no efficacy-related important protocol deviations)|||units on a scale||Standard Error|Least Squares Mean
2642834|NCT01733069|Primary|APTIMA Combo 2 Assay Accuracy Compared to Infected Status by Sample Type|Count of participants having a positive or negative APTIMA Combo 2 assay result (sensitivity and specificity)|Baseline|Results for 4 gender-specific sample types were reported for 2 targets (CT, Chlamydia trachomatis; and GC, Neisseria gonorrhoeae infection). In this observational study, 1313 females (143 CT and/or GC-infected) and 549 males (121 CT and/or GC infected) contributed to one or more analyses.|||participants|||Number
2642835|NCT01733056|Primary|Influenza Hemagluttination Inhibition Titers Measured Against Pandemic H1N1 Strains Before and After Influenza Vaccination|Influenza hemagluttination inhibition titers were measured against pandemic H1N1 strains before and after influenza vaccination. Titers greater than or equal to 1:40 constitute a protective response to influenza strains.|28 days||||participants|||Number
2642836|NCT01733056|Primary|Influenza Hemagluttination Inhibition Titers Measured Against H3N2 Perth Before and After Influenza Vaccination|Influenza hemagluttination inhibition titers were measured against H3N2 Perth before and after influenza vaccination. Titers greater than or equal to 1:40 constitute a protective response to influenza strains.|28 days||||participants|||Number
2642837|NCT01732926|Secondary|Overall Survival (OS)|Overall survival is defined as the interval from randomization to death from any cause.||Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.||||||
2642838|NCT01732926|Secondary|Lymph Node Response Rate|Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
2642839|NCT01732926|Secondary|Overall Response Rate (ORR)|Overall response rate is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response (VGPR) or minor response (MR) for participants with Waldenstrom's). ORR was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
2642840|NCT01732926|Secondary|Complete Response Rate (CR)|Complete response rate is defined as the proportion of participants who achieve a complete response. CR rate was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
2642841|NCT01732926|Primary|Progression-free Survival (PFS)|PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
2642842|NCT01732913|Secondary|Overall Survival|Overall survival is defined as the interval from randomization to death from any cause.||Due to the early termination of the study, efficacy data were not mature for all participants, and therefore the prespecified analyses were not conducted.||||||
2642843|NCT01732913|Secondary|Complete Response Rate|Complete response rate is defined as the proportion of participants who achieve a complete response. Complete response rate was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
2642844|NCT01732913|Secondary|Lymph Node Response Rate|Lymph node response rate is defined as the proportion of participants who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions. Lymph node response rate was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
2642845|NCT01732913|Secondary|Overall Response Rate|Overall Response Rate (ORR) is defined as the proportion of participants who achieve a complete response or partial response (or very good partial response or minor response for participants with Waldenstrom's). ORR was to be assessed by an IRC.||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
2642846|NCT01732913|Primary|Progression Free Survival|Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. PFS was to be assessed by an independent review committee (IRC).||Due to the early termination of the study, efficacy data were not available for all participants, and therefore the prespecified analyses were not conducted.||||||
2642847|NCT01732835|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||l/min/m^2||Standard Deviation|Mean
2642848|NCT01732835|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||l/min/m^2||Standard Deviation|Mean
2642849|NCT01732835|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||l/min||Standard Deviation|Mean
2642850|NCT01732835|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||l/min||Standard Deviation|Mean
2642851|NCT01732835|Secondary|LVEF - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||percentage of blood volume||Standard Deviation|Mean
2642852|NCT01732835|Secondary|LVEF - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||percentage of blood volume||Standard Error|Mean
2642853|NCT01732835|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||ml||Standard Deviation|Mean
2642854|NCT01732835|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||ml||Standard Deviation|Mean
2642855|NCT01732835|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||ml||Standard Deviation|Mean
2642856|NCT01732835|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||ml||Standard Deviation|Mean
2642857|NCT01732835|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||cm||Standard Deviation|Mean
2642858|NCT01732835|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||cm||Standard Deviation|Mean
2642859|NCT01732835|Secondary|LVID Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 2 years|Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.|||cm||Standard Deviation|Mean
2642860|NCT01732835|Secondary|LVID Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline and 6 months|Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.|||cm||Standard Deviation|Mean
2645026|NCT01714310|Secondary|Diastolic Blood Pressure|Diastolic Blood pressure measured in mmHG.|Baseline through week 12.|Some participants discontinued as trial progressed.|||mm Hg.||Standard Error|Least Squares Mean
2642867|NCT01732835|Secondary|New York Heart Association (NYHA) Functional Capacity Classification at 2 Years|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|2 years|Participants with an evaluation of this measure.|||participants|||Number
2642868|NCT01732835|Secondary|New York Heart Association (NYHA) Functional Capacity Classification at 6 Months|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|6 months|Participants with an evaluation of this measure.|||participants|||Number
2642869|NCT01732835|Secondary|Aortic Insufficiency (AI) at 2 Years|Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)|2 years|Participants with an echocardiogram evaluable for this measure.|||participants|||Number
2642870|NCT01732835|Secondary|Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure||2 years||||percentage of participants||95% Confidence Interval|Number
2642871|NCT01732835|Secondary|Actuarial Freedom From Clinical Cardiovascular Events|Freedom from specified clinical cardiovascular events at 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months|6 months||||percentage of participants||95% Confidence Interval|Number
2642872|NCT01732835|Secondary|Implant Procedure Success|Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure: - Aortic annular dissection, rupture, or leaflet damage - Mitral valve impingement due to implant - implant dehiscence/migration into aorta - implant dehiscence/migration into left ventricle - Hemodynamics requiring intervention - Other adverse event resulting in reoperation, explantation, or permanent disability.|discharge or 14 days postprocedure, whichever comes first||||percentage of implant procedures||95% Confidence Interval|Number
2642873|NCT01732835|Primary|Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months|Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)|6 months|Participants with an echocardiogram evaluable for this measure.|||participants|||Number
2642874|NCT01732835|Primary|Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure||6 months||||percentage of participants||95% Confidence Interval|Number
2642875|NCT01732822|Other Pre-specified|Premature Permanent Discontinuation of Study Drug Due to Any Bleeding Event|Participants with a permanent discontinuation of study drug due to any bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)|From the date of first dose and up to and including 7 days following the date of last dose of study drug|The population was the saftey analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or clopidogrel and for whom post-dose data are available|||Participant|||Number
2642876|NCT01732822|Other Pre-specified|PLATO Major Bleeding Events|Participants with PLATO major bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)|From the date of first dose and up to and including 7 days following the date of last dose of study drug|The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or clopidogrel and for whom post-dose data are available|||Participant|||Number
2642877|NCT01732822|Other Pre-specified|TIMI Major or Minor Bleeding Events|Participants with TIMI major or minor bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)|From the date of first dose and up to and including 7 days following the date of last dose of study drug|The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or clopidogrel and for whom post-dose data are available|||Participant|||Number
2642878|NCT01732822|Other Pre-specified|TIMI Major Bleeding Events|Participants with TIMI major bleeding event. If no event, censoring occurs at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)|From the date of first dose and up to and including 7 days following the date of last dose of study drug|The population was the safety analysis set, which included all patients who received at least 1 dose of randomized ticagrelor or clopidogrel and for whom post-dose data are available|||Participant|||Number
2642879|NCT01732822|Other Pre-specified|CV-related Hospitalization|Participants with hospitalization associated with CV death, hospitalization due to MI, ischemic stroke, lower extremity revascularization, major amputation due to PAD, transient ischemic attack (TIA), coronary revascularization or unstable angina. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
2642880|NCT01732822|Other Pre-specified|Major Amputation Caused by PAD|Participants with major amputation caused by PAD. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
2642881|NCT01732822|Other Pre-specified|Any Amputation Caused by PAD|Participants with any amputation caused by peripheral arterial disease (PAD). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
2642898|NCT01732822|Primary|Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke|Participants with CV death, myocardial infarction (MI) or ischemic stroke. If no event, censoring occurs at the minimum of (primary analysis censoring date (PACD), last endpoint assessment date, non-CV death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients.|||Participants|||Number
2642899|NCT01732796|Secondary|SVR24|Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24).|24 Week (post-treatment)|FAS|||Percantage of participants|||Number
2642882|NCT01732822|Other Pre-specified|Change in ABI/TBI From Baseline|"Change in ankle brachial index (ABI) / toe brachial index (TBI).~Ankle brachial index (ABI) is the ratio of blood pressures from the ankle and arm and is used for diagnosing peripheral arterial occlusive disease (PAOD):~Normal: 1 to 1.29 Borderline: 0.91 to 0.99 Mild PAOD: 0.71 to 0.90 Medium severe PAOD: 0.41 to 0.7 Severe PAOD: <0.4~Toe brachial index (TBI) is the ratio between the toe pressure and the higher brachial pressure, used for diagnosing PAOD when the ABI cannot be used:~Normal: >0.7 Mild: 0.5-0.7 Moderate: 0.35-0.5 Moderate-Severe: <0.35 and toe pressure 40 mmHg Severe: <0.35 and toe pressure < 30 mmHg"|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Change in ABI/TBI||Standard Deviation|Mean
2642883|NCT01732822|Other Pre-specified|Changes in Rutherford Classification|"Progression of the clinical/symptomatic status of the limb by changes in Rutherford classification.~Category 0 - Asymptomatic Category 1 - Mild claudication Category 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Category 3 - Severe claudication Category 4 - Rest pain Category 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Category 6 - Severe ischemic ulcers or frank gangrene"|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
2642884|NCT01732822|Other Pre-specified|Changes in Fontaine Stage|"Progression of the clinical/symptomatic status of the limb by changes in Fontaine stage.~Stage I - Asymptomatic Stage IIa - Intermittent claudication after more than 200 meters of pain free walking Stage IIb - Intermittent claudication after less than 200 meters of walking Stage III - Rest pain Stage IV - Ischemic ulcers or gangrene"|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
2642885|NCT01732822|Other Pre-specified|Non-CV Death|Participants with non-CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, CV death)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
2642886|NCT01732822|Other Pre-specified|Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/TIMI Major Bleeding)|Participants with all-cause death, MI, ischemic stroke, ALI, major amputation or Thrombolysis in Myocardial Infarction (TIMI) major bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
2642887|NCT01732822|Other Pre-specified|Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/Fatal Bleeding/Intracranial Bleeding)|Participants with all-cause death, MI, ischemic stroke, ALI, major amputation, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
2642888|NCT01732822|Other Pre-specified|Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding)|Participants with all-cause death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
2642889|NCT01732822|Other Pre-specified|Net Clinical Benefit (Composite of CV Death/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding)|Participants with CV death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
2642890|NCT01732822|Secondary|Any Revascularisation (Coronary, Peripheral [Limb, Mesenteric, Renal, Carotid and Other])|Participants with any revascularization. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
2642891|NCT01732822|Secondary|Lower Extremity Revascularization|Participants with lower extremity revascularization (LER). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
2642892|NCT01732822|Secondary|ALI|Participants with ALI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
2642893|NCT01732822|Secondary|Composite of CV Death, MI, and All-cause Stroke (Ischemic or Hemorrhagic)|Participants with CV death, MI or all-cause stroke. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
2642894|NCT01732822|Secondary|All-cause Mortality|Participants with all-cause death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
2642895|NCT01732822|Secondary|MI|Participants with MI. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
2642896|NCT01732822|Secondary|CV Death|Participants with CV death. If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
2642897|NCT01732822|Secondary|Composite of CV Death, MI, Ischemic Stroke, and ALI|Participants with CV death, MI, ischemic stroke or acute limb ischemia (ALI). If no event, censoring occurs at the minimum of (PACD, last endpoint assessment date, non-CV death date)|From randomization to PACD, an average of 2.5 years|The population was the full analysis set, which included all randomized patients|||Participant|||Number
2642902|NCT01732796|Primary|SVR12 Rates With Historical Control|Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C Virus ribonucleic acid (HCV RNA) level <25 international units/millilitre (IU/mL) at 12 weeks after End of Treatment (EoT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint|12 Week (post-treatment)|The primary analyses of efficacy were carried out on an intent-to-treat basis including all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication (FAS).|||Percentage of participants|||Number
2642903|NCT01732783|Secondary|Type of Post-Panitumumab Anti-cancer Treatment|Participants may have received more than one type of anti-cancer treatment that was initiated after panitumumab discontinuation.|12 months|Participants who reported use of anti-cancer treatment after discontinuation of panitumumab|||participants|||Number
2642904|NCT01732783|Secondary|Number of Participants With Anti-cancer Treatment After Panitumumab Discontinuation||12 months||||participants|||Number
2642905|NCT01732783|Secondary|Number of Participants With Resectability|Resectability denotes whether a participant became resectable during the study.|12 months||||Participants|||Count of Participants
2642906|NCT01732783|Secondary|Percentage of Participants With an Overall Response|Tumor response was assessed by the investigator using standard radiological imaging. Overall response is defined as a best tumor response of complete response or partial response according to Response Evaluation Criteria In Solid Tumours (RECIST).|12 months|Participants with tumor response data post-baseline|||percentage of participants||95% Confidence Interval|Number
2642907|NCT01732783|Secondary|Reasons for Hospitalization|Participants may have had more than one hospital visit and/or reason for a hospital visit.|12 months|Participants with at least one hospitalization|||participants|||Number
2642908|NCT01732783|Secondary|Duration of Hospital Stay||12 months|Participants with at least one hospital visit|||days||Inter-Quartile Range|Median
2642909|NCT01732783|Secondary|Types of Hospital Visit|Participants may have had more than one type of hospital visit.|12 months|Participants with at least one hospital visit|||participants|||Number
2642910|NCT01732783|Secondary|Number of Participants With at Least One Hospitalization||12 months||||Participants|||Count of Participants
2642911|NCT01732783|Primary|Percentage of Participants With at Least One Concomitant Chemotherapy Dose Delay||12 months||||percentage of participants|||Number
2642912|NCT01732783|Primary|Percentage of Participants With at Least One Concomitant Chemotherapy Dose Reduction||12 months||||percentage of participants|||Number
2642913|NCT01732783|Primary|Duration of Exposure of All Concomitant Chemotherapy|Duration of exposure is the time from the first date to the last date of chemotherapy administration.|12 months||||months||Inter-Quartile Range|Median
2642914|NCT01732783|Primary|Reasons for Discontinuation of Panitumumab||12 months|Participants who discontinued panitumumab while on study|||Participants|||Count of Participants
2642915|NCT01732783|Primary|Percentage of Participants With at Least One Panitumumab Dose Delay||12 months||||percentage of participants||95% Confidence Interval|Number
2642916|NCT01732783|Primary|Percentage of Participants With at Least One Panitumumab Dose Reduction||12 months||||percentage of participants||95% Confidence Interval|Number
2642917|NCT01732783|Primary|Mean Interval Between Panitumumab Infusions||12 months||||Participants|||Count of Participants
2642918|NCT01732783|Primary|Duration of Panitumumab Exposure|Duration of exposure is the time from the first to the last panitumumab infusion|12 months||||months||Inter-Quartile Range|Median
2642919|NCT01732783|Primary|Maximum Dose of Panitumumab||12 months||||mg||Inter-Quartile Range|Median
2642920|NCT01732783|Primary|Cumulative Dose of Panitumumab||12 months||||mg||Inter-Quartile Range|Median
2642921|NCT01732783|Primary|Total Number of Panitumumab Infusions||12 months||||infusions||Inter-Quartile Range|Median
2642922|NCT01732770|Secondary|Percent Change From Baseline in Total Hip BMD at Month 12 - Superiority Analysis||Baseline and Month 12|The primary efficacy analysis set; any postbaseline BMD value obtained at the early termination visit was carried forward as the month 12 value (ie, LOCF).|||percent change||95% Confidence Interval|Least Squares Mean
2642923|NCT01732770|Secondary|Percent Change From Baseline in Lumbar Spine BMD at Month 12 - Superiority Analysis||Baseline and Month 12|The primary efficacy analysis set; any postbaseline BMD value obtained at the early termination visit was carried forward as the month 12 value (ie, LOCF).|||percent change||95% Confidence Interval|Least Squares Mean
2642924|NCT01732770|Secondary|Percent Change From Baseline in Total Hip BMD at Month 12 - Non-inferiority Analysis|BMD of the hip was measured by DXA. DXA scans were analyzed by a central imaging facility.|Baseline and Month 12|The primary efficacy analysis set; any postbaseline BMD value obtained at the early termination visit was carried forward as the month 12 value (ie, LOCF).|||percent change||95% Confidence Interval|Least Squares Mean
2642925|NCT01732770|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 - Non-inferiority Analysis|Bone mineral density (BMD) of the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging facility.|Baseline and Month 12|The primary efficacy analysis set includes all randomized participants who have a baseline BMD measurement and at least one postbaseline BMD measurement. Any postbaseline BMD value obtained at the early termination visit was carried forward as the month 12 value (ie, last observation carried forward [LOCF]).|||percent change||95% Confidence Interval|Least Squares Mean
2642926|NCT01732757|Secondary|Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0|Tearing is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less tearing.|Day 0|All randomized subjects with data at this time point|||Scores on a Scale||Standard Deviation|Mean
2645027|NCT01714310|Secondary|Systolic Blood Pressure|Systolic Blood Pressure measured in mmHG|Baseline through week 12.|Some participants discontinued as trial progressed.|||mm Hg.||Standard Error|Least Squares Mean
2642927|NCT01732757|Secondary|Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0|Eyelid swelling is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score eyelid swelling on a 4-point numeric analog scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less lid swelling.|Day 0|All randomized subjects with data at this time point|||Scores on a Scale||Standard Deviation|Mean
2642928|NCT01732757|Secondary|Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0|Chemosis is swelling of the tissue that lines the eyelids and surface of the eye. Chemosis is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score chemosis on a 9-point numeric analog scale ranging from 0=None to 4=Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less chemosis.|Day 0|All randomized subjects with data at this time point|||Scores on a Scale||Standard Deviation|Mean
2642929|NCT01732757|Secondary|Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0|The episclera is the tissue that lies over the white part of the eye. Episcleral redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score episcleral redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less episcleral redness.|Day 0|All randomized subjects with data at this time point|||Scores on a Scale||Standard Deviation|Mean
2642930|NCT01732757|Secondary|Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0|Ciliary redness is redness spreading out around the cornea of the eye. Ciliary redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score ciliary redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less ciliary redness.|Day 0|All randomized subjects with data at this time point|||Scores on a Scale||Standard Deviation|Mean
2642931|NCT01732757|Secondary|Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0|The conjunctiva is a thin membrane that covers the inner surface of the eyelid and the white part of the eye. Conjunctival redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score conjunctival redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less conjunctival redness.|Day 0|All randomized subjects with data at this time point|||Scores on a Scale||Standard Deviation|Mean
2642932|NCT01732757|Secondary|Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0|Ocular itching is evaluated by the subject at Hour 16 post challenge on Day 0. Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed).|Day 0|All randomized subjects with data at this time point|||Percentage of Subject Eyes|Participants||Number
2642933|NCT01732757|Secondary|Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0|Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Zero itch is considered a score = 0.|Day 0|All randomized subjects with data at this time point|||Percentage of Subjects|||Number
2642934|NCT01732757|Secondary|Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0|Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Minimal itching is considered a score <1.|Day 0|All randomized subjects with data at this time point|||Percentage of Subjects|||Number
2642935|NCT01732757|Secondary|Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0|Ocular itching is evaluated by the subject at 5 and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.|Day 0|All randomized subjects with data at this time point|||Scores on a Scale||Standard Deviation|Mean
2642936|NCT01732757|Primary|Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0|Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.|Day 0 at 3 Minutes Post Challenge|All randomized subjects with data at this time point|||Scores on a Scale||Standard Deviation|Mean
2642937|NCT01732718|Secondary|Change From Baseline to Week 6 in Tricuspid Regurgitant (TR) Jet.|Echocardiogram will be used to assess TR jet before and after treatment.|Baseline, Week 6||||m/sec||95% Confidence Interval|Mean
2642938|NCT01732718|Secondary|Change From Baseline to Week 6 in TF-mediated sFLT Release From Monocytes|Flow cytometry will be performed to assess TF-mediated sFLT release from monocytes at baseline and at 6 weeks of treatment.|Baseline, 6 weeks|The stored samples did not survive the freeze/thaw process and as such, this data was not attainable.||||||
2642939|NCT01732718|Secondary|Change From Baseline to Week 6 in Tissue Factor (TF) Expression|Flow cytometry will be performed to assess TF expression at baseline and at 6 weeks of treatment.|Baseline, 6 weeks|The stored samples did not survive the freeze/thaw process and as such, this data was not attainable.||||||
2643468|NCT01728324|Secondary|SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.|Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT.|4 weeks (after End Of Treatment)|FAS|||percentage of participants||95% Confidence Interval|Number
2642940|NCT01732718|Secondary|Mean Change From Baseline to Week 6 in Absolute Cell Counts|Flow cytometry will be performed to assess absolute cell counts at baseline and at 6 weeks of treatment.|Baseline, 6 weeks|Intent was to perform analysis using flow cytometry but cells did not survive thawing. Decision was made to use CBC laboratory values for absolute monocyte (AMC), lymphocyte (ALC) and neutrophil (ANC) counts to perform the analysis.|||10^9 cells/L||95% Confidence Interval|Mean
2642941|NCT01732718|Secondary|Change From Baseline to Week 6 in Plasma Levels of Vascular Endothelial Growth Factor (VEGF)|Investigators will measure plasma levels of vascular endothelial growth factor (VEGF) at baseline and at 6 weeks of treatment.|Baseline, 6 weeks||||pg/mL||Inter-Quartile Range|Mean
2642942|NCT01732718|Secondary|Change From Baseline to Week 6 in Rho/Rho Kinase Activity|The expression and activity of rho/rho kinase will be determined at baseline and at 6 weeks of treatment.|Baseline, 6 weeks|Due to loss of key study personnel these data were not collected||||||
2642943|NCT01732718|Secondary|Abnormal Physical Findings.|Subjects will be evaluated by physical examination and/or measurement of vital signs at each study visit.|Baseline, 2, 4, and 6 weeks during treatment, and at follow-up.||||participants|||Number
2642944|NCT01732718|Secondary|Occurrence of Adverse Events.|Subjects will be evaluated for safety by patient self-report of adverse events and results of laboratory tests.|Continuously from randomization through end of study||||events|||Number
2642945|NCT01732718|Secondary|Change From Baseline to Week 6 in Renal Function|Investigators will assess the effect of atorvastatin on albuminuria by spot urine microalbuminuria/creatinine ratio measured at baseline and at 6 weeks of treatment.|Baseline, 6 weeks||||ug per mg||Inter-Quartile Range|Median
2642946|NCT01732718|Secondary|Change From Baseline to Week 6 in Monocyte Activation|Flow cytometry performed to assess monocyte activation at baseline and at 6 weeks of treatment.|Baseline, 6 weeks|The stored samples did not survive the freeze/thaw process and as such, this data was not attainable.||||||
2642947|NCT01732718|Secondary|Change From Baseline to Week 6 in Plasma Levels of Soluble Fms-like Tyrosine Kinase-1 (sFLT-1)|Investigators will measure plasma levels of soluble fms-like tyrosine kinase-1 (sFLT-1) at baseline and at 6 weeks of treatment.|Baseline, 6 weeks||||pg/mL||Inter-Quartile Range|Median
2642948|NCT01732718|Secondary|Change From Baseline to Week 6 in Heme Oxygenase Activity|The expression and activity of heme oxygenase-1(HO-1)will be determined at baseline and at 6 weeks of treatment.|Baseline, 6 weeks|Data not collected||||||
2642949|NCT01732718|Secondary|Change From Baseline to Week 6 in Plasma Markers of Endothelial Activation|Investigators will measure plasma levels of soluble vascular cell adhesion molecules (sVCAM) and soluble intracellular adhesion molecule (sICAM) at baseline and at 6 weeks of treatment.|Baseline, 6 weeks|Investigators elected to look at only one marker of vascular endothelial injury, i.e. sVCAM, so there is no data for sICAM.|||ng/mL||Inter-Quartile Range|Mean
2642950|NCT01732718|Primary|Change From Baseline to Week 6 in Endothelial Function|Endothelial function will be assessed using ultrasound imaging of the brachial artery, with measurement of endothelium-dependent (flow-mediated) and endothelium-independent (nitroglycerin-mediated) dilation of the artery measured in millimeters (mm).|Baseline, 6 weeks||||% diameter change||Inter-Quartile Range|Median
2642951|NCT01732692|Secondary|Percentage of Patients Who Experienced Adverse Events (AEs)|An AE was a worsening in severity or frequency of a concomitant illness or any new illness diagnosed during the clinical trial period. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability / incapacity; is a congenital anomaly / birth defect; is medically important. Severity is a clinical observation and describes the intensity of the event: Mild: Transient symptoms, no interference with daily activities; Moderate: Marked symptoms, moderate interference with daily activities; Severe: Considerable interference with daily activities. Relatedness to study drug was assessed by the Investigator.|From first dose of study drug until the end of colonoscopy procedure, maximum of 24 hours.|Safety population|||percentage of participants|||Number
2642952|NCT01732692|Secondary|Patient Compliance - Amount of Additional Clear Liquid Consumed|To prevent any potential dehydration risk participants were recommended the intake of at least 500 ml of additional clear liquid (juices without pulp, tea, water) per liter of the Moviprep solution. The amount of additional clear liquid taken is reported for each liter of Moviprep taken.|1 day (the day of colonoscopy)|Intent-to-treat population with available data|||ml||Standard Deviation|Mean
2642953|NCT01732692|Secondary|Total Compliance Score|"Compliance score = 100 * (total amount MOVIPREP® intake) / (planned MOVIPREP intake).~Total compliance score of MOVIPREP is the average score of the compliance for the first and second litre."|1 day (the day of colonoscopy)|Intent-to-treat with available data|||units on a scale||Standard Deviation|Mean
2642954|NCT01732692|Secondary|Patient Satisfaction of Colonoscopy Preparation (VAS)|"Patient satisfaction was measured on a 100 mm visual analog scale (VAS) where 0 (left end of the line) is marked as totally unacceptable (lowest patient satisfaction of colonoscopy preparation) and 100 is fully acceptable (highest patient satisfaction with the procedure). Satisfaction was scored based on a mark placed on the line by the participant."|1 day (the day of colonoscopy)|Intent-to-treat population with available VAS data.|||units on a scale||Standard Deviation|Mean
2642955|NCT01732692|Primary|Percentage of Participants With Successful Colon Cleansing|Bowel cleansing was assessed by a blinded endoscopist through visual evaluation of 5 colon segments and scored using the Harefield Cleansing Scale (HCS): A = success, all segments clean/scored 4 or 3; B = success, ≥1 segment with liquid/semi-solid amounts of stool, fully removable, ≥1 segment scored 2; C = failure, ≥1 segment with semi-solid or solid amounts of stool, at least 1 segment scored 1; and D = failure, ≥ 1 segment with irremovable, heavy, hard stools, ≥ 1 segment scored 0. Segmental evaluation of colon cleansing scores is as follows: 4: Colon empty and clean, no remaining stool or liquid. 3: Presence of clear liquid in the gut which can be removed by suction. 2: Brown liquid or semisolid remaining amounts of stool, fully removable. 1: Semisolid amounts of stool, only partially removable, difficult to make colonoscopy; 0: Irremovable, heavy, hard stools, colonoscopy impossible. Success of cleansing was defined as Grades of bowel cleansing А and В.|1 day (the day of colonoscopy)|Intent-to-treat population|||percentage of participants|||Number
2642956|NCT01732640|Secondary|Overall Response After Chemoradiation|To estimate the overall response rate after completion of chemoradiation|5 years|Patients were taken off study before the full 5 years could be completed, therefore data was not collected for this outcome measure.||||||
2642958|NCT01732640|Secondary|Activity of Afatinib Based on Serial FLT-PET/CT and DW-MRI|To estimate the activity of afatinib by obtaining serial FLT-PET/CT and DW-MRI, And compare to standard of care CT images (which will be acquired at baseline and at the completion of treatment, and categorized per RECIST criteria) and correlated with response.|5 Years|Patients were taken off study before the full 5 years could be completed, therefore data was not collected for this outcome measure.||||||
2642959|NCT01732640|Secondary|Biological Marker Activity of Afatinib|To estimate the biological marker activity of afatinib by serial sampling of tumor and blood samples from patients, and correlate with clinical and pathological response and outcomes. On- and off-target effects of afatinib will be assessed for the biological marker activity.|5 Years|Patients were taken off study before the full 5 years could be completed, therefore data was not collected for this outcome measure.||||||
2642960|NCT01732640|Secondary|Median Overall Survival at 2 Years|To estimate the median overall survival.|2 Years|Patients were taken off study before the full 2 years could be completed, therefore data was not collected for this outcome measure.||||||
2642961|NCT01732640|Secondary|2 Year Progression Free Survival (PFS)|To estimate the 2 year progression free survival.|2 Years|Patients were taken off study before the full 2 years could be completed, therefore data was not collected for this outcome measure.||||||
2642962|NCT01732640|Secondary|Overall Response After Chemoradiation|To estimate the overall response rate after completion of chemoradiation.|5 Years|Patients were taken off study before the full 5 years could be completed, therefore data was not collected for this outcome measure.||||||
2642963|NCT01732640|Primary|Number of Participants With Dose Limiting Toxicities|Grade 3 or 4 neutropenia (ie. absolute neutrophil count <1000 cells/mm^3) that was associated with a fever>38.5 degrees C or lasting longer than 5 days, grade 3 thrombocytopenia with bleeding or grade 4 thrombocytopenia, and any grade 3 or 4 non-hematologic toxicity per CTCAE criteria which were probably or definitely related to study therapy. During the chemoradiation, an event of stomatitis, pharyngitis, mucositis, or dermatitis was not considered to be a dose limiting toxicity unless it was a grade 4 that did resolve to <grade 2 with a radiation treatment break (not to exceed 10 days) or with withholding chemotherapy (not to exceed 2 weekly doses).|1 year (average)||||Participants|||Count of Participants
2642964|NCT01732640|Primary|Objective Tumor Response|Patients were accessed for response by CT/MRI and clinical exam. Partial response was defined as a greater than 30 % reduction in tumor size.|After completion of 2 cycles of induction chemotherapy (at least 8 weeks)||||Participants|||Count of Participants
2642965|NCT01732640|Primary|Maximum Tolerated Dose (MTD) of Afatinib|The maximally tolerated dose (MTD) was defined as the dose of afatinib in which <2 of 6 patients experience a DLT with the next higher dose having at least 2 of up to 6 patients experiencing a DLT. No dose escalations or de-escalations are permitted within each subject's treatment.|1 Year (Average)||||mg|||Number
2642966|NCT01732588|Secondary|OZ439 Tmax|Time of maximum observed plasma drug concentrations (Tmax)|pre dose, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose|"PK population included all subjects who received at least 1 dose of IMP and who had sufficient plasma concentration data for PK parameter estimation.~In addition, for Regimen C only subjects in whom the activation was performed successfully at the target site were included for this regimen."|||hours||Full Range|Median
2642967|NCT01732588|Primary|OZ439 Cmax|The maximum observed plasma drug concentrations (Cmax)|pre dose, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose|"PK population included all subjects who received at least 1 dose of IMP and who had sufficient plasma concentration data for PK parameter estimation.~In addition, for Regimen C only subjects in whom the activation was performed successfully at the target site were included for this regimen."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2642968|NCT01732588|Primary|OZ439 AUC0-∞|Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)|pre dose, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post dose|"PK population included all subjects who received at least 1 dose of IMP and who had sufficient plasma concentration data for PK parameter estimation.~In addition, for Regimen C only subjects in whom the activation was performed successfully at the target site were included for this regimen."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2642969|NCT01732549|Secondary|Safety Profile of Tasquinimod|Number of subjects reporting adverse events|At regular intervals during the study treatment period and every 3 months during the follow-up until death (approximately up to 2.5 years)|Safety Population: All patients who received at least one dose of study treatment. Patients were allocated to the treatment they actually received|||participants|||Number
2642970|NCT01732549|Secondary|Change From Baseline of EuroQol-5 Dimension QoL Instrument (EQ-5D) VAS Score|"Baseline is defined as last measurement collected prior to the first dose of study drug. End of Study visit (within 14 days of last dose of study treatment)~The EQ-5D, a 5-item scale useful in health resource utilisation and cost comparisons between treatment groups designed for self-completion by patients consists of two pages [EQ-5 descriptive system and EQ Visual Analogue Scale(VAS)]. The EQ-5 descriptive system comprises five dimensions: mobility, self care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, severe problems. The EQ-VAS records the respondent's self-rated health on a vertical VAS. The respondents are asked to mark health status on the day of the interview on a 10cm vertical scale with end points of 0 to100. There are notes at the both ends of the scale that the bottom rate(0) corresponds to the worst health you can imagine, and the highest rate(100) corresponds to the best health you can imagine"|Baseline and End-of-study Visit (approximately up to 2.5 years)|ITT population|||Score on scale||Inter-Quartile Range|Median
2642971|NCT01732549|Secondary|Time to Deterioration in Functional Assessment of Cancer Therapy - Prostate (FACT-P)|"End of Study visit (within 14 days of last dose of study treatment)~Impact of tasquinimod on health related quality of life (QoL) - Analysis of time to deterioration in FACT-P~The FACT-P measurement system is a validated collection of health related quality of life (HRQOL) questionnaires used to assess HRQOL in men with prostate cancer. It is appropriate for use with patients with any form of cancer and extensions of it have been used and validated in other chronic illness condition. The FACT-P is a self-administered 39-item scale comprising five domains: physical well-being, social/family well-being, functional well-being, emotional well-being and additional concerns. The individual subscale scores range from 0 to a high between 24 and 48 and the total score ranges between 0 and 156, with higher scores representing better Quality of Life (QoL)"|Up to End of Study visit (approximately up to 2.5 years)|ITT population|||weeks||90% Confidence Interval|Median
2642973|NCT01732549|Secondary|Symptomatic PFS Based on Number of Subjects Who Had Symptomatic Progression or Death|"Symptomatic PFS is defined as the time from the date of randomisation to the date of symptomatic progression or death due to prostate cancer, whichever occurs first [symptomatic progression as assessed by Brief Pain Inventory (BPI) and analgesic use].~Symptomatic progression was defined by the occurrence of pain with documented disease, skeleton related adverse events.~The median symptomatic PFS for placebo and tasquinimod groups was not reached.~Tasquinimod: Patients censored = 48, Patients at risk (t=0) = 71 Placebo: Patients censored = 54, Patients at risk (t=0) = 73"|Every 8 weeks until symptomatic or radiological progression documentation (approximately up to 2.5 years)|ITT Population|||participants|||Number
2642974|NCT01732549|Secondary|Time to Progression Free Survival [PFS] on Next-line Therapy (PFS 2)|"The time from the date of randomisation to the date of radiological progression free survival [PFS] on next-line therapy (PFS 2) or death due to any cause.~Radiological progression was defined~- Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue lesions (Eisenhauer, EJC 2009), as at least a 20% relative and a 5 mm absolute increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters recorded on study (including Screening or the appearance of one or more new lesions) for target Lesions.~Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions~- Using Prostate Cancer Clinical Working Group in March 2008 (PCWG2) criteria for bone lesions (Scher, JCO 2008). Progression was defined as appearance of 2 or more bone lesions."|Every 3 months after study treatment stop (follow-up) until progression under the next line therapy (approximately up to 2.5 years)|ITT Population|||weeks||90% Confidence Interval|Median
2642975|NCT01732549|Secondary|Overall Survival Based on Number of Subjects Who Died|"Overall survival is defined as the time from randomisation to death due to any cause.~The number of participants who died is presented since the Median was not reached for this assessment.~Tasquinimod: Patients censored = 63, Patients at risk (t=0) = 71 Placebo: Patients censored = 67, Patients at risk (t=0) = 73"|Every 3 months after study treatment stop until death (approximately up to 2.5 years)|ITT Population|||participants|||Number
2642976|NCT01732549|Primary|Time to Radiological Progression Free Survival [PFS]|"The time from the date of randomisation to the date of radiological progression or death due to any cause.~Radiological progression was defined~- Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue lesions (Eisenhauer, EJC 2009), as at least a 20% relative and a 5 mm absolute increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters recorded on study (including Screening or the appearance of one or more new lesions) for target Lesions.~Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions~- Using Prostate Cancer Clinical Working Group in March 2008 (PCWG2) criteria for bone lesions (Scher, JCO 2008). Progression was defined as appearance of 2 or more bone lesions."|Every 8 weeks until disease progression documentation (approximately up to 2.5 years)|Intention to treat (ITT) Population|||weeks||90% Confidence Interval|Median
2642977|NCT01732536|Secondary|Percentage of Patients Indicated for Revision Endoscopic Sinus Surgery (RESS)|"To be indicated for RESS, the following criteria had to be met:~Continued to use topical intranasal steroids daily;~Continued to complain of at least 2 symptoms of chronic sinusitis despite ongoing topical intranasal steroid use~Needed or had received at least 1 course of aggressive steroid therapy or had refused such therapy due to intolerance/side effects; and~Had endoscopic evidence of persisting ethmoid sinus obstruction (bilateral polyp grade >=2 on at least one side)"|90 days, 6 months|Intent-to-treat population consisted of all patients in whom an implant or sham procedure was attempted. There were 2 (2.0%) participants (1 treatment, 1 control) who withdrew from the study prior to Day 90. No imputation of missing values was performed.|||Participants|||Count of Participants
2642978|NCT01732536|Secondary|Nasal Obstruction Symptom Evaluation (NOSE) Score|NOSE scale is a validated symptom scoring instrument consisting of 5 questions each scored by patients on a 5-point Likert scale from 0 (not a problem) to 4 (severe problem), then multiplied by 5 and resulting in a total score ranging from 0 to 100. Negative values for change from baseline represented reduction (improvement) in NOSE score.|6 months|Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 3 (3.0%) participants (1 treatment, 2 control) with missing values at Month 6. No imputation of missing values was performed.|||units on a scale||Standard Deviation|Mean
2642979|NCT01732536|Secondary|Bilateral Polyp Grade|Polyps were graded by clinical investigators on a scale from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline indicate reduction (improvement) in nasal polyps.|90 days, 6 months|Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 3 (3.0%) participants (1 treatment, 2 control) with missing values at 90 days and 4 (4.0%) participants (2 treatment, 2 control) with missing values at Month 6. No imputation of missing values was performed.|||units on a scale||Standard Error|Mean
2642980|NCT01732536|Secondary|Ethmoid Sinus Obstruction|Percentage of the ethmoid sinus volume obstructed by scarring, polyps, or edema on endoscopy, as determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review using a 100-mm visual analogue scale (VAS), ranging from 0 (absence of obstruction) to 100 (complete obstruction). Negative values for change from baseline represented reduction (improvement) in ethmoid sinus obstruction.|90 days|Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There was1 (1.0%) participant (treatment) with missing values at baseline and Day 90. No imputation of missing values was performed.|||units on a scale||Standard Deviation|Mean
2642981|NCT01732536|Primary|Bilateral Polyp Grade|Polyp grade was determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review. Each sinus was graded from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline represented reduction (improvement) in bilateral polyp grade.|90 days|Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 2 (2%) participants (2 treatment, 0 control) with missing values. No imputation of missing values was performed. Negative values for change from baseline represent improvement.|||units on a scale||Standard Deviation|Mean
2642982|NCT01732536|Primary|Nasal Obstruction/Congestion Score|Nasal Obstruction by patients using a paper questionnaire on a scale from 0 (no problem) to 5 (problem as bad as it can be). Negative values for change from baseline represented reduction (improvement) in|90 days|Intent-to-treat population. Values were adjusted for steroid and surgical interventions by LOCF approach. There were 3 (3%) participants (1 treatment, 2 control) with missing values at Day 90. No imputation of missing values was performed.|||units on a scale||Standard Deviation|Mean
2642983|NCT01732510|Secondary|Number of Participants Positive for Anti-Drug Antibody (ADA) Formation|Testing for ADA positivity and neutralizing response and antibody titre quantification are performed with blood (serum) samples collected at baseline (Day 1 predose) and Days 14, 28, 42, 56, 74, 112, and 224. Neutralizing response refers to ADA neutralizing interference with study drug assessed in vitro. Non-Treatment emergent ADA refers to presence of ADAs (as determined by assay) in the absence of treatment with study drug (i.e., at predose).|Days 1 (predose) and Days 14, 28, 42, 56, 74, 112, and 224|The ADA evaluable population defined as all participants with at least one ADA sample available after treatment with MK-8226 or placebo was used for analysis.|||Participants|||Number
2642984|NCT01732510|Secondary|Percentage of Participants With >=50% Improvement in EASI Score|The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).|Baseline, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
2642985|NCT01732510|Other Pre-specified|Change From Baseline in the Participant's Global Impression of Disease Status in Study Part 2|Participant subjective impression of improvement of his/her disease condition is scored on a six-point scale: 0 (Clear) to 5 (Very severe disease).|Baseline, Week 4, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
2642986|NCT01732510|Secondary|Number of Participants Requiring As-Needed Oral Antihistamines as Rescue Medication in Study Part 2|Oral antihistamines (i.e., diphenhydramine, acrivastine fenistil) were provided as as-needed rescue medication for severe pruritus.|Up to Week 12|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
2642987|NCT01732510|Secondary|Change From Baseline in Participant Sleep Disturbance in Study Part 2|Sleep disturbance (sleep loss, disruption, or interference) due to unremitting pruritus and other causes is a quality of life issue in moderate to severe atopic dermatitis. Participant subjective assessment of sleep disturbance (component of SCORAD) over the past 3 days is rated on a VAS ranging from 1 to 10 cm (increasing severity).|Baseline, Week 4, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
2642988|NCT01732510|Secondary|Change From Baseline in Participant Pruritus in Study Part 2|Skin pruritus (itching) is a typical characteristic of atopic dermatitis. Participant subjective assessment of pruritus (component of SCORAD) is rated on a VAS ranging from 1 to 10 cm (increasing severity).|Baseline, Week 4, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
2642989|NCT01732510|Secondary|Change From Baseline in the Scoring Atopic Dermatitis Scale (SCORAD) in Study Part 2|The SCORAD index scale combines 1) intensity of six lesion characteristics (erythema, edema/papulation, oozing/crusts, excoriations, lichenification, dryness) as assessed by the physician on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities) along with 2) subjective symptoms of pruritus and sleep disturbance as reported by the patient on a visual analog scale (VAS) from 1 to 10 cm (increasing severity). Physician assessment of affected areas in each region is made as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The final SCORAD index score, ranging from 0 (absent disease) to 103 (severe disease), is calculated according to the weighted formula: (0.2 x area) + (3.5 x [sum of intensity score for each of the 6 items]) + participant's subjective score.|Baseline, Week 4, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
2642990|NCT01732510|Secondary|Percentage of Participants With an Investigator Global Assessment (IGA) Score of Clear or Almost Clear in Study Part 2|"Percentage of participants achieving an IGA of atopic dermatitis of clear-0 or almost clear-1. The IGA is a six-point scale measuring the severity of disease at time of physical examination of the participant by the physician. The IGA is scored 0 (Clear) to 5 (Very severe disease)."|Baseline, Week 4, Week 8, Week 12, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
2642991|NCT01732510|Secondary|Change From Baseline in the Eczema Area and Severity Index (EASI) for Study Part 2|The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).|Baseline, Week 4, Week 8, Week 24|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
2642992|NCT01732510|Secondary|Terminal Half Life (t1/2) of MK-8226 Following Multiple Dose Intravenous Administration|t1/2, the time needed for the concentration of drug to reach half the initial concentration, was determined for the last period of dosing (starting Week 10 [Day 70]) up to the last measurement. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224|The PP population defined as all participants compliant with study procedure with data available (t1/2) from at least one treatment was used for analysis.|||days||Geometric Coefficient of Variation|Geometric Mean
2642993|NCT01732510|Secondary|Volume of Distribution (Vd) of MK-8226 Following Multiple Intravenous Administration|Vd, a theoretical approximation of degree to which the drug distributes in body tissue rather than plasma (higher Vd indicates greater tissue distribution), was determined for the last period of dosing (starting Week 10 [Day 70]) in the treatment period. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224|The PP population defined as all participants compliant with study procedure with data available (Vd) from at least one treatment was used for analysis.|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
2642994|NCT01732510|Secondary|Clearance (CL) of MK-8226 Following Multiple Dose Intravenous Administration|CL, the volume of plasma cleared of drug per unit time, was determined for the last period of dosing (starting Week 10 [Day 70]) in the treatment period. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 28 (incl. predose), 42 (incl. predose), 56 (incl. predose), 70 (incl. predose), 72, 74, and 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 1, 3, 5, 9, 14, 28, 42, 56, 70, 72, 74, 84|The PP population defined as all participants compliant with study procedure with data available (CL) from at least one treatment was used for analysis.|||mL/day/kg||Geometric Coefficient of Variation|Geometric Mean
2642995|NCT01732510|Secondary|Maximum Serum Concentration (Cmax) of MK-8226 Following Multiple Dose Intravenous Administration|Cmax was determined for the first and last periods of MK-8226 dosing. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 70 (incl. predose), 72, 74, and 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 1, 3, 5, 9, 14, 70, 72, 74, 84|The PP population defined as all participants compliant with study procedure with data available (Cmax) from at least one treatment was used for analysis.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2642996|NCT01732510|Secondary|AUC From Time 0 to Last Measurement (AUC0-last) of MK-8226 Following Multiple Intravenous Dose Administration|AUC0-last defined as AUC up to the last measured concentration was determined for the last period of dosing (starting Week 10 [Day 70]) up to the last measurement. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 70 (incl. predose), 72, 74, 84, 98, 112, 140, 168, 196, and 224. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 70, 72, 74, 84, 98, 112, 140, 168, 196, 224|The PP population defined as all participants compliant with study procedure with data available (AUC0-last) from at least one treatment was used for analysis.|||μg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2642997|NCT01732510|Secondary|Area Under the Concentration-time Curve of MK-8226 From Time 0 to Tau (AUC0-tau) Following Multiple Intravenous Dose Administration|AUC(0-tau) defined as AUC from time zero to tau where tau is the dosing interval (312 hours) was determined for the first and last periods of MK-8226 dosing. MK-8226 was administered on Days 1, 14, 28, 42, 56, and 70. Blood concentrations of MK-8226 were determined on Days 1 (incl. predose), 3, 5, 9, 14 (incl. predose), 70 (incl. predose), 72, 74, 84. The placebo group is not included; this endpoint evaluated only the MK-8226 groups. No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis.|Days 1, 3, 5, 9, 14, 70, 72, 74, 84|The Per-Protocol (PP) population defined as all participants compliant with study procedure with data available (AUC0-tau) from at least one treatment was used for analysis.|||μg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2642998|NCT01732510|Secondary|Plasma Chemokine (C-C Motif) Ligand 22 (CCL22) Level in Study Part 2|CCL22 is a pro-allergic chemokine that is assessed in human plasma. Levels of CCL22 are increased in allergic disease states.|Baseline, 48 Hours, Week 2, Week 4, Week 12, Week 16|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from BL in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
2642999|NCT01732510|Secondary|Plasma Chemokine (C-C Motif) Ligand 17 (CCL17) Level in Study Part 2|CCL17 is a pro-allergic chemokine that is assessed in human plasma. Levels of CCL17 are increased in allergic disease states.|Baseline, 48 Hours, Week 2, Week 4, Week 12, Week 16|No analysis was performed for Part 2 non-safety secondary endpoints after the Part 1 primary endpoint (Change from Baseline [BL] in EASI) did not demonstrate adequate effect in an interim futility analysis. The study was early terminated from a business perspective.||||||
2643379|NCT01729247|Primary|FeNO Values by ACT Score|Scores on an asthma control test (ACT) of <=19 indicates less well controlled asthma, scores >19 indicate well controlled asthma. Force exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. FeNO measures were compared against ACT scores.|Study Visit (single visit study). Approximately 1 hour.||||parts per billion (ppb)||Standard Deviation|Mean
2643000|NCT01732510|Primary|Change From Baseline in the Eczema Area and Severity Index (EASI) for Study Part 1|Reduction from baseline in EASI at Week 12 (interim analysis data). The EASI assesses intensity of four lesion characteristics (erythema, infiltration/population, excoriation, lichenification) each rated on a scale of 0 (absent) to 3 (severe) across four regions (head, trunk, upper and lower extremities). Affected areas in each region are assessed as percentage of body surface (head [10%], trunk [30%], upper extremities [20%], and lower extremities [40%]). The total score is a sum of each region score and can range from 0 (absent disease) to 72 (severe disease).|Baseline, Week 12|The Full Analysis Set (FAS) defined as all randomized subjects who received at least one dose of study treatment with baseline and at least one post-dose assessment (EASI) was used for analysis.|||Score on a scale||Standard Deviation|Mean
2643001|NCT01732510|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to 12 Weeks|The ASaT population defined as all participants who received at least one dose of investigational drug was used for analysis.|||participants|||Number
2643002|NCT01732510|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.|Up to 32 Weeks|The All Subjects as Treated (ASaT) population defined as all participants who received at least one dose of investigational drug was used for analysis.|||participants|||Number
2643003|NCT01732484|Secondary|Percentage of Eyes With Neodymium:Yttrium-aluminium-garnet (Nd:YAG) Capsulotomy|Treatment of PCO in neodymium:yttrium-aluminium-garnet (Nd:YAG) capsulotomy. The frequency of this treatment will be asseseed in percentage values|3 years||||percentage of eyes|Participants||Number
2643004|NCT01732484|Primary|Posterior Capsule Opacification (PCO)|PCO = migration of lens epithelial cells behind the IOL optic after cataract surgery; scale 0-10 (0: no PCO; 10: maximum PCO)|3 years||||units on a scale (0-10)||Standard Deviation|Mean
2643005|NCT01732471|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in Overall Safety Population|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Week 11|Overall safety population included all participants who received at least 1 dose of investigational medicinal product.|||participants|||Number
2643006|NCT01732471|Secondary|Percent Change From Baseline in Blood Phenylalanine Levels at Day 8 in Sub-population of Responders|Percent change in blood phenylalanine levels after 8-day Kuvan® therapy (response test period) was calculated as (blood phenylalanine level at Day 8 minus blood phenylalanine level at baseline)*100/ blood phenylalanine level at baseline.|Baseline, Day 8|Sub-population of responders included participants with reduction in blood phenylalanine levels of greater than or equal to 30% at Day 8 as compared to baseline.|||percent change||Standard Deviation|Mean
2643007|NCT01732471|Secondary|Percent Change From Baseline in Blood Phenylalanine Levels at Day 8 in Overall Population|Percent change in blood phenylalanine levels after 8-day Kuvan® therapy (response test period) was calculated as (blood phenylalanine level at Day 8 minus blood phenylalanine level at baseline)*100/ blood phenylalanine level at baseline.|Baseline, Day 8|Overall (ITT) population included all participants who had efficacy assessment result from at least 1 visit except for the inclusion visit.|||percent change||Standard Deviation|Mean
2643008|NCT01732471|Primary|Percentage of Participants With Response to Kuvan® (Sapropterin Dihydrochloride) Treatment|Response to Kuvan® (sapropterin dihydrochloride) treatment was defined as a reduction in blood phenylalanine levels of greater than or equal to 30% at Day 8 as compared to baseline.|Day 8|Overall (ITT) population included all participants who had efficacy assessment result from at least 1 visit except for the inclusion visit.|||percentage of participants||95% Confidence Interval|Number
2643009|NCT01732458|Primary|Percentage of Participants Discontinuing Study Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants discontinuing study due to an AE was reported by dose group.|From pre-operative phase up to Follow-up (Day 1 to Day 15)|All randomized participants who received at least one dose of study treatment were analyzed.|||percentage of participants|||Number
2643072|NCT01732211|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2,4,8,12,14, 16 and 20|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.|Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20|No subjects were analyzed due to early termination of the study and the small enrollment number.||||||
2643380|NCT01729208|Secondary|Incidence of Adverse Events|Cumulative incidence of adverse events.|36 months||||participants|||Number
2643010|NCT01732458|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the SPONSOR's product, was also an AE. Changes resulting from normal growth and development which did not vary significantly in frequency or severity from expected levels were not to be considered adverse events. Vomiting and retching were not defined as AEs during the period of data collection (24 hours following the end of surgery) unless they met the definition of an SAE. The percentage of participants experiencing ≥1 AE was reported by dose group.|From pre-operative phase up to Follow-up (Day 1 to Day 15)|All randomized participants who received at least one dose of study treatment were analyzed.|||percentage of participants|||Number
2643011|NCT01732458|Primary|Apparent Terminal Half-life (t ½) of Aprepitant Following Administration of Single Dose|Plasma for aprepitant t ½ assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. t ½ data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. t ½) was not possible.||||||
2643012|NCT01732458|Primary|Apparent Total Clearance (CL/F) of Aprepitant From Plasma Following Administration of Single Dose|Plasma for aprepitant CL/F assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. CL/F data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. CL/F) was not possible.||||||
2643013|NCT01732458|Primary|Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC0-inf) Following Administration of Single Dose|Plasma for aprepitant AUC0-inf assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. AUC0-inf data were to be log transformed and analyzed via a linear mixed-effects model containing fixed effects for age for each dose level tested.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Due to the lack of samples beyond 8 hours after dose, the assessment of the terminal elimination phase of the PK profiles was limited and derivation of parameters dependent on lambda (e.g. AUC0-inf) was not possible.||||||
2643014|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group|Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
2643015|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group|Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643053|NCT01732445|Primary|Best Overall Response Rate as Determined by International Working Group Criteria|Best overall response rate as determined by International Working Group criteria: An evaluable patient will be classified as a responder for the primary endpoint if the patient's best overall response is CR, PR or CI (Clinical Improvement) as determined by International Working Group Criteria over all cycles of study treatment. The percentage of successes will be estimated by the number of successes (defined as complete response, partial response, or clinical improvement) divided by the total number of evaluable patients times 100. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.|Up to 2 years||||percentage of patients with CR, PR or CI||95% Confidence Interval|Number
2643381|NCT01729208|Secondary|Incidence of Adverse Events|Cumulative incidence of adverse events.|24 months||||participants|||Number
2643016|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in Birth to <2 Year Age Group|AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged from birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643017|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group|Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
2643018|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group|Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643019|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 2 to <6 Year Age Group|AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643020|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group|Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
2643021|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group|Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643054|NCT01732419|Secondary|Patient Satisfaction|Patient satisfaction is measured directly after CR discharge (12 weeks) using the Consumer Quality Index, a standardized survey method combining the inventory of patient experiences with an assessment of their priority. Results are provided on a scale of 1 (very low satisfaction) to 10 (very high satisfaction).|Measured at CR discharge (12 weeks)|Patients finished the CR program (12 weeks)|||units on a scale||Standard Deviation|Mean
2643022|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 10 mg Dose Equivalent in 6 to <12 Year Age Group|AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643023|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group|Tmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
2643024|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group|Cmax was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643025|NCT01732458|Primary|AUC0-last Following Administration of 10 mg Dose Equivalent in 12 to 17 Year Age Group|AUC0-last was analyzed independently for participants in the 10 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 10 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643026|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group|Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
2643027|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group|Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due aprepitant concentration in the pre-dose sample.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643055|NCT01732419|Secondary|Health Related Quality of Life|Health-related quality of life will be assessed by the MacNew questionnaire. The items and scale are scored from 1 (low health-related Quality of Life) to 7 (High health-related Quality of Life).|measured at baseline, at discharge (12 weeks), and follow-up (one year)|Patients finished the study|||Units of a scale||Standard Deviation|Mean
2643028|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in Birth to <2 Year Age Group|AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due aprepitant concentration in the pre-dose sample.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643029|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group|Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
2643030|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group|Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643031|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 2 to <6 Year Age Group|AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643032|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group|Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
2643033|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group|Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643056|NCT01732419|Secondary|Training Adherence|Provides information on the average amount of training sessions were performed during the 12 week cardiac rehabilitation program. Both groups received the advice to train at least 2 times a week for 12 weeks (thus 24 sessions).|12 weeks|Patients finished the CR program|||Exercise sessions completed||Standard Deviation|Mean
2643034|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 40 mg Dose Equivalent in 6 to <12 Year Age Group|AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643035|NCT01732458|Primary|Tmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group|Tmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
2643036|NCT01732458|Primary|Cmax Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group|Cmax was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643037|NCT01732458|Primary|AUC0-last Following Administration of 40 mg Dose Equivalent in 12 to 17 Year Age Group|AUC0-last was analyzed independently for participants in the 40 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 40 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643038|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group|Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
2643039|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group|Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. One participant was excluded from the analysis due to aprepitant concentration in the pre-dose sample.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643131|NCT01731119|Secondary|Number of Participants Experiencing Side Effects|Assessment of the medication side effects associated with lurasidone (Latuda©) in children and adolescents.|Baseline to12 weeks||||Participants|||Count of Participants
2643382|NCT01729208|Secondary|Incidence of Adverse Events|Cumulative incidence of adverse events.|12 months||||participants|||Number
2643040|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in Birth to <2 Year Age Group|AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged birth to <2 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged birth to <2 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed. Two participants were excluded from the analysis, due to a missing 8-hour post-dose sample and aprepitant concentration in the pre-dose sample, respectively.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643041|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group|Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
2643042|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group|Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643043|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 2 to <6 Year Age Group|AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 2 to <6 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 2 to <6 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643044|NCT01732458|Primary|Tmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group|Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr||Geometric Coefficient of Variation|Geometric Mean
2643045|NCT01732458|Primary|Cmax of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group|Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643233|NCT01730040|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2643046|NCT01732458|Primary|AUC0-last of Aprepitant Following Administration of 125 mg Dose Equivalent in 6 to <12 Year Age Group|AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 6 to <12 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 6 to <12 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643047|NCT01732458|Primary|Time to Maximum Concentration (Tmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group|Tmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Tmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Tmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hour (hr)||Geometric Coefficient of Variation|Geometric Mean
2643048|NCT01732458|Primary|Maximum Concentration (Cmax) of Aprepitant Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group|Cmax was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant Cmax assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma Cmax was evaluated using an NCA. The LOQ value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643049|NCT01732458|Primary|Area Under the Concentration-time Curve of Aprepitant From Time 0 to the Last Measurable Concentration (AUC0-last) Following Administration of 125 mg Dose Equivalent in 12 to 17 Year Age Group|AUC0-last was analyzed independently for participants in the 125 mg dose equivalent arm aged 12 to 17 years old due to age- and dose-dependent differences in aprepitant absorption and clearance. Because the opportunity to collect specimens for PK analyses in children is limited, a flexible sparse sampling scheme using ranges of collection times was to be utilized which would limit the burden to participants. Plasma for aprepitant AUC0-last assessment was obtained at 30-60 minutes prior to aprepitant administration, 2-4 hours post aprepitant administration, 5-7 hours post aprepitant administration, and 8-10 hours post aprepitant administration. Post-operative aprepitant plasma AUC0-last was evaluated using a noncompartmental analysis (NCA). The limit of quantitation (LOQ) value for this analysis was 10 ng/mL.|30-60 minutes pre-administration, 2-4 hours post administration, 5-7 hours post administration, 8-10 hours post administration|Participants aged 12 to 17 years who received a single dose of 125 mg aprepitant prior to surgery with available plasma samples were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2643050|NCT01732445|Other Pre-specified|Patient-reported Symptoms Assessed Using the MPN-SAF, as Measured by the Percentage of Patients With a Decrease in MPN-SAF TSS Greater Than 50% From Baseline|Patient-reported symptoms will be described at each time point using the mean, confidence interval, median, and range. The Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) will be analyzed using published scoring algorithms. MPN-SAF includes 27 items scored on a scale of 0 to 10. The MPN-SAF Total Symptom Score (TSS) (range 0-100) was computed according to the published scoring algorithm. Higher scores represent worse symptom burden. The percentage of patients with a decrease in MPN-SAF TSS greater than 50% from baseline and 95% confidence interval are reported below.|Baseline to up to 2 years||||percentage of patients||95% Confidence Interval|Number
2643051|NCT01732445|Secondary|Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)|"The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below."|Up to 2 years||||percentage of patients|||Number
2643052|NCT01732445|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. The median and 95% confidence interval are reported below.|From registration to death due to any cause, assessed up to 2 years||||months||95% Confidence Interval|Median
2643071|NCT01732211|Secondary|Change From Baseline in % Predicted FEV1 at Weeks 2,4,8,12,14, 16 and 20|The percent predicted FEV1 was calculated by observed FEV1/predicted FEV1 * 100. The predicted FEV1 values was calculated according to age, height, race and gender. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.|Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20|No subjects were analyzed due to early termination of the study and the small enrollment number.||||||
2643057|NCT01732419|Primary|Physical Activity Level (PAL)|PAL is calculated by combining data from an accelerometer with data from a heart monitor, after wearing both for five days continuously. To determine PAL, physical activity energy expenditure is divided by resting metabolic rate, calculated by the Harris-Benedict equation. PAL expressed a person's daily energy expenditure. When PAL is used to classify the intensity of an activity, PAL<3, PAL<6 and PAL>6 are characterized as light, moderate and vigorous intensity activities respectively. An average daily PAL of 1.2 represents the activity level of a bed-bound subject, while the average PAL for the adult population is 1.7.|measured after 12 weeks and after one year|Patients finished the study|||PAL||Standard Deviation|Mean
2643058|NCT01732419|Primary|Physical Fitness|Changes in peak oxygen uptake (VO2max) in mL O2/kg/min|Measured after 12 weeks and after one year|patients finished the study|||ml O2/kg/min||Standard Deviation|Mean
2643059|NCT01732406|Secondary|36-Item Short Form Survey (SF-36) Mental Health Summary Score|The Mental Health Summary Score of the SF-36 measures quality of life with a focus on mental health. It ranges from 0 to 100 points on a scale. Higher scores indicate better quality of life. This survey is scored as demonstrated at https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. The Mental Health Summary Score (Mental Component Summary) is calculated as the mean average of the emotionally relevant questions.|Cross-sectional at baseline||||points on a scale||Standard Deviation|Mean
2643060|NCT01732406|Secondary|36-Item Short Form Survey Instrument (SF-36) Physical Health|The Physical Health Summary Score of the SF-36 is a quality of life measure of physical health. It ranges from 0 to 100 points on a scale. Higher scores indicate better quality of life. This survey is scored as demonstrated at https://www.rand.org/health/surveys_tools/mos/36-item-short-form/scoring.html. The Physical Health Summary Score (Physical Component Summary) is calculated as the mean average of the physically relevant questions.|Cross-sectional at baseline||||points on a scale||Standard Deviation|Mean
2643061|NCT01732406|Secondary|The Gastrointestinal Quality of Life Index (GIQLI) Total Score|The total score for the Gastrointestinal Quality of Life Index (GIQLI) measures quality of life with specific attention to gastrointestinal symptoms. The score ranges from 0-144 points on a scale. Higher scores indicating better quality of life.|Cross-sectional at baseline||||points on a scale||Standard Deviation|Mean
2643062|NCT01732406|Primary|Acromegaly Quality of Life (ACROQoL) Global Score|The Global Score of the Acromegaly Quality of Life (ACROQoL) Survey measures quality of life in patients with acromegaly. Higher scores indicate better QOL. The range is 22-110 units on a scale.|Cross-sectional at baseline|Patients receiving either no treatment (active acromegaly), pegvisomant monotherapy or somatostatin analog monotherapy from own doctor to treat acromegaly.|||points on a scale||Standard Deviation|Mean
2643063|NCT01732263|Primary|Volume of Distribution (Vz/F) of SSP-004184|The distribution of a medication between plasma and the rest of the body.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||L/kg||Standard Deviation|Mean
2643064|NCT01732263|Primary|Total Body Clearance (CL/F) of SSP-004184|The rate at which a drug is removed from the body.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||L/h/kg||Standard Deviation|Mean
2643065|NCT01732263|Primary|Plasma Half-Life (T 1/2) of SSP-004184|The time it takes for the blood plasma concentration of a substance to halve.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||hours||Standard Deviation|Mean
2643066|NCT01732263|Primary|Time of Maximum Plasma Concentration (Tmax) for SSP-004184|Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||hours||Full Range|Median
2643067|NCT01732263|Primary|Maximum Plasma Concentration (Cmax) of SSP-004184|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||ng/ml||Standard Deviation|Mean
2643068|NCT01732263|Primary|Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 96 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set consists of all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||ng*h/ml||Standard Deviation|Mean
2643069|NCT01732211|Secondary|Estimated Treatment Effect Over Placebo in FVC Averaged Over 16 Weeks|FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Through FVC was obtained from spirometry, performed before study treatment administration.|Baseline, Weeks 0, 2, 4, 8, 12, 14, 16|No subjects were analyzed due to early termination of the study and the small enrollment number.||||||
2643070|NCT01732211|Secondary|Change From Baseline in Ratio of FEV1/FVC at Weeks 2,4,8,12,14, 16 and 20|FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.|Baseline, Weeks 2, 4, 8, 12, 14, 16, and 20|No subjects were analyzed due to early termination of the study and the small enrollment number.||||||
2643073|NCT01732211|Secondary|Change From Baseline Absolute in FVC (% Predicted) Compared to Placebo at Weeks 2,4,8,12,14, and 20|The percent predicted FVC was calculated by observed FVC/predicted FVC * 100. The predicted FVC values was calculated according to age, height, race and gender. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Weeks 2, 4, 8, 12, 14, and 20|No subjects were analyzed due to early termination of the study and the small enrollment number.||||||
2643074|NCT01732211|Secondary|Change From Baseline in FVC (Absolute ) Compared to Placebo at Weeks 2,4,8,12, 14, and 20|FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.|Baseline, Weeks 2, 4, 8, 12, 14, and 20|No subjects were analyzed due to early termination of the study and the small enrollment number.||||||
2643075|NCT01732211|Secondary|Change From Baseline in Chest X-ray Global Assessment Score (5-point )|Digital copies of Chest x-rays performed during the study were graded according to a 5 point Likert scale: 1 = markedly worsened; 2 = worsened; 3 = unchanged; 4 = improved; and 5 = markedly improved. Baseline will be defined as the last available x-ray prior to first dose.|Baseline, Week 16|No subjects were analyzed due to early termination of the study and the small enrollment number.||||||
2643076|NCT01732211|Primary|Change From Baseline (Absolute) in % Predicted Forced Vital Capacity (FVC) Compared to Placebo at Week 16|The percent predicted FVC was calculated by observed FVC/predicted FVC * 100. The predicted FVC values was calculated according to age, height, race and gender. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.|Baseline, Week 16|No subjects were analyzed due to early termination of the study and the small enrollment number.||||||
2643077|NCT01732107|Other Pre-specified|Characterize Post-treatment Bladder Tissue Dovitinib Concentrations.|Post-treatment bladder tissue dovitinib concentrations will be assessed by TURBT fresh frozen tissue obtained at the 3-month cystoscopy|12 months|9 subjects had sufficient tissue available to measure dovitinib tissue concentration|||nmol/L|||Number
2643078|NCT01732107|Other Pre-specified|Characterize Concordance Rates Between UC Patient Detected Tumor, Urine, and Circulating Free Plasma FGFR3 Mutations.|Presence of FGFR3 mutations within patient free plasma will be assessed by polymerase chain reaction (PCR) amplification of the target regions and sequencing.|12 months|Data for this outcome measure was neither collected or analyzed due to the early termination of the study.||||||
2643079|NCT01732107|Other Pre-specified|Characterize Associations Between Post-treatment Hypertension, 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.|Hypertension will be defined as a systolic blood pressure (SBP) of > 140 mmHg or a diastolic blood pressure (DBP) of > 90 mm Hg recorded at any time after dovitinib therapy is initiated.|12 months|Data for this outcome measure was neither collected or analyzed due to the early termination of the study.||||||
2643080|NCT01732107|Other Pre-specified|Characterize Associations Between Pre-treatment Germline VEGFR SNPs and Post-treatment 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.|Pre-treatment germline VEGFR SNPs will be assessed by testing extracted DNA from patient PBMC's (collected prior to initiating dovitinib therapy) with validated commercial probes.|12 months|Data for this outcome measure was neither collected or analyzed due to the early termination of the study.||||||
2643081|NCT01732107|Other Pre-specified|Characterize Pre- and Post-treatment VEGFR Pathway Phosphorylation Changes as Assessed by Bladder Tumor Tissue Immunohistochemistry.|Pre- and post-treatment bladder tumor VEGFR pathway phosphorylation changes will be assessed by bladder tumor tissue immunohistochemistry utilizing commercially available antibodies including, but not limited to, the following: FGFR3, pFGFR3, VEGFR2, pVEGFR2, FRS2, pFRS2, ERK, pERK.|12 months|Data for this outcome measure was neither collected or analyzed due to the early termination of the study.||||||
2643082|NCT01732107|Other Pre-specified|Characterize Associations Between Pre-treatment Germline, FGFR Single-nucleotide Polymorphisms (SNPs) and Post-treatment 6-month Complete Response Rate and 1-year Relapse Free Survival Rate in Patients Treated With Dovitinib.|Pre-treatment germline FGFR SNPs will be assessed by testing extracted Deoxyribonucleic acid (DNA) from patient peripheral blood mononuclear cells (PBMC's) (collected prior to initiating dovitinib therapy) with validated commercial probes.|12 months|Data for this outcome measure was neither collected or analyzed due to the early termination of the study.||||||
2643083|NCT01732107|Other Pre-specified|Characterize Pre- and Post-treatment Bladder Tumor FGFR Pathway Phosphorylation Changes.|Pre- and post-treatment bladder tumor FGFR pathway phosphorylation changes will be assessed by bladder tumor tissue immunohistochemistry utilizing commercially available antibodies including, but not limited to, the following: fibroblast growth factor receptors (FGFR3, pFGFR3), vascular endothelial growth factor receptors (VEGFR2, pVEGFR2), fibroblast growth factor receptor substrates (2FRS2, pFRS2), extracellular signal-regulated kinases (ERK), phosphorylated extracellular signal-related kinase (pERK).|12 months|Data for this outcome measure was neither collected or analyzed due to the early termination of the study.||||||
2643084|NCT01732107|Secondary|Characterize Treatment-related Toxicity Rates|Treatment-related toxicity rates will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All grade 3-4 adverse events and other adverse events occurring in more than 20% of patients are reported.|12 months||||participants|||Number
2643085|NCT01732107|Secondary|Determine 3-Month and 6-Month Partial Response Rates|The 3- and 6-month partial response rates are defined as the proportion of patients treated with persistent but reduced T-stage tumors on post-therapy TURBT (i.e., T1 ≥ Ta; T1+Tis ≥ T1).|6 months|Data for this outcome measure was neither collected or analyzed due to the early termination of the study.||||||
2643086|NCT01732107|Secondary|Determine Rate of Progression to Muscle-Invasive Stage|The rate of progression to muscle-invasive stage for dovitinib is defined as the proportion of patients with clinical or pathologic progression to muscle-invasive stages (i.e., T2-T4) at any time point on study.|12 months|Data for this outcome measure was neither collected or analyzed due to the early termination of the study.||||||
2643087|NCT01732107|Secondary|Determine 1-Year Relapse-Free Survival Rate|The 1-year relapse free survival rate is defined as the proportion of patients treated with dovitinib with no evidence of any remaining urothelial carcinoma tumors at 12 months of follow-up.|12 months|Data for this outcome measure was neither collected or analyzed due to the early termination of the study.||||||
2643088|NCT01732107|Primary|Determine 6-Month Complete Response Rate|The 6-month complete response rate is defined as the proportion of patients treated with dovitinib with no evidence of any remaining urothelial carcinoma tumors of any T-stage (including Tis) present within the bladder as assessed by standard of care cystoscopic examination with transurethral resection of bladder tumor (TURBT) and urine cytology performed at 6 months after initiation of study therapy.|6 months||||percentage of participants|||Number
2643089|NCT01731990|Secondary|High Sensitivity C-reactive Protein (hsCRP) Ratio of 12 Months to Baseline|Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects.|Baseline, 12 months post-dose|The PD analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. Patients with baseline and 12 month data are included in this analysis.|||Ratio||Standard Error|Least Squares Mean
2643090|NCT01731990|Secondary|Serum Amyloid A (SAA) Level Ratio of 12 Months to Baseline|Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects.|Baseline, 12 months post-dose|The PD analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. Patients with baseline and 12 month data are included in this analysis.|||Ratio||Standard Error|Least Squares Mean
2643091|NCT01731990|Secondary|Number of Patients With Adverse Events in 12 Months|Summary statistics on adverse event is reported. It is categorized as number of patients in total adverse events (non serious and serious AEs), serious adverse event, death.|Baseline to 12 months post-dose|All patients that received any study drug were included in the safety analysis set.|||Participants|||Count of Participants
2643092|NCT01731990|Primary|Mean Vessel Wall Area Ratio of 12 Months to Baseline|Peripheral artery wall area (superficial femoral artery) measured using Magnetic Resonance Imaging (MRI) cross-section slices. Mean vessel wall area (mm^2) was derived by converting total plaque volume (TPV) (mL) of the vessel to mm^3 by multiplying by 1000, dividing by the number of slices used for the volume calculation, and dividing by the thickness of a slice (3 mm). Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, the treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects.|Baseline, 12 months post-dose|The pharmacodynamics (PD) analysis set included all patients with available PD data and no protocol deviations with relevant impact on PD data. Patients who underwent iliac/femoral stenting were removed from all data points that occurred after this procedure in the analysis.|||Ratio||Standard Error|Least Squares Mean
2643093|NCT01731938|Secondary|Treatments Failures|"The following were considered treatment failures:~Persistent bleeding at the TBS beyond T4, Breakthrough (brisk and forceful) bleeding from the TBS that jeopardized subject safety according to the investigator's judgment at any moment during the 10 minute observational period and until TClosure, Re-bleeding at the TBS after the assessment of the primary efficacy endpoint at T4 and until TClosure Use of alternative hemostatic treatments or maneuvers (other than the study treatment) at the TBS during the 10-minute observational period and until TClosure or use of study treatment at the TBS beyond T4 and until TClosure."|From start of treatment to time of completion of surgical closure.||||percentage of subjects|||Number
2643094|NCT01731938|Secondary|Cumulative Proportion of Subjects Achieving Hemostasis at the Target Bleeding Site by 2 (T2), 3 (T3), 5 (T5), 7 (T7), and 10 (T10) Minutes After TStart.||From start of treatment to 2, 3, 5, 7, and 10 minutes after start of treatment||||percentage of subjects|||Number
2643095|NCT01731938|Secondary|Time to Hemostasis (TTH)|TTH was measured from the start of treatment to the achievement of hemostasis at the target bleeding site, or to the end of the 10-minute observational period when hemostasis had not yet been achieved.|From start of treatment to the end of the 10-minute observational period||||minutes||Standard Error|Mean
2643096|NCT01731938|Primary|Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start|Subjects achieving hemostasis at the target bleeding site within 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.|From start of treatment until 4 minutes after treatment start||||percentage of participants|||Number
2643097|NCT01731912|Primary|Tissue Levels of Testosterone in Prostate Tissue as Measured by Mass Spectometry||At week 24|Tissue testosterone levels at 24 weeks|||pg/mg||Standard Deviation|Median
2643098|NCT01731912|Primary|Tissue Levels of DHT in Prostate Tissue as Measured by Mass Spectometry|Differences in tissue androgen levels between this group and historical comparisons will be evaluated by performing a one-way analysis of variance (ANOVA), followed by pair-wise two-sample t-tests to determine which groups are statistically different.|At week 24|Tissue DHT at 24 weeks|||pg/mg||Standard Deviation|Median
2643099|NCT01731886|Secondary|Progression Free Survival (PFS)|PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.|2 years|Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2643100|NCT01731886|Secondary|Progression Free Survival (PFS)|PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.|4 years|Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2643101|NCT01731886|Secondary|Overall Survival Rate (OS)|To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.|2 years|Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2643234|NCT01730040|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
2643102|NCT01731886|Secondary|Overall Survival Rate (OS)|To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.|4 years|Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2643103|NCT01731886|Primary|Complete Response Rate|The primary objective of this study is to determine the complete response rate of lenalidomide and low-dose dexamethasone versus that of lenalidomide and low-dose dexamethasone followed by autologous peripheral blood stem cell transplant in patients with newly diagnosed multiple myeloma (will include unconfirmed complete response (CR), CR and stringent complete response (sCR)).|3 years|1 participant in Arm B never started treatment.|||Participants|||Count of Participants
2643104|NCT01731678|Other Pre-specified|Interim Analysis - Ham-D|There will be an interim analysis to review response (Ham-D) after the first 10 rTMS patients. Should there be significant concerns, the team will terminate the study. Ten was selected as it is close to previous reports and should be informative.|After the first 10 patients are completed|||||||
2643105|NCT01731678|Other Pre-specified|Interim Analysis - rTMS Tolerability Scale|There will be an interim analysis to review safety, tolerability (as measured by our rTMS tolerability scale) after the first 10 rTMS patients. Should there be significant concerns, the team will terminate the study. Ten was selected as it is close to previous reports and should be informative.|After the first 10 patients are completed|||||||
2643106|NCT01731678|Primary|Hamilton Depression Rating Scale|Response defined as: a reduction of Hamilton Depression Rating Scale score of 50% or more Name: Hamilton Depression Rating Scale Construct: Depression Range: 0-52 Direction: Higher is worse depression symptoms/severity Sub-scales: Not applicable. Reference: Hamilton M. Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol. 1967 Dec;6(4):278-96.|Three weeks||||score on a scale||Standard Deviation|Mean
2643107|NCT01731600|Secondary|Clearance Evaluated for N8-GP|Total plasma clearance of drug after intravenous administration measured as actual dose/AUC. A chromogenic assay with PSS as calibrator was used.|From 1 hour prior to and up to 96 hours after initial administration of N8-GP.|Results were based on FAS.|||mL/h/kg||95% Confidence Interval|Least Squares Mean
2643108|NCT01731600|Secondary|Clearance Evaluated for Previous FVIII Product|Total plasma clearance of drug after intravenous administration measured as actual dose/AUC. A chromogenic assay with NHP as calibrator was used.|2-6 weeks prior to initial dosing with N8-GP and up to 30 hours after administration of previous FVIII product|Results were based on FAS.|||mL/h/kg||95% Confidence Interval|Least Squares Mean
2643109|NCT01731600|Secondary|Terminal Half-life Evaluated for N8-GP|t½ = ln(2) / λz, where λz is the terminal elimination rate. The terminal elimination rate was planned estimated using linear regression on the terminal part of the time versus log(concentration) curve. A population-based method simultaneously estimating individual t½ values for all patients was applied, including patients with few values above the LLOQ. This was estimated using time points from 6h to 96h. A chromogenic assay with PSS as calibrator was used.|From 1 hour prior to and up to 96 hours after initial administration of N8-GP|Results were based on FAS.|||hours||Geometric Coefficient of Variation|Geometric Mean
2643110|NCT01731600|Secondary|Terminal Half-life Evaluated for Previous FVIII Product|t½ = ln(2) / λz, where t½ is terminal half-life and λz is the terminal elimination rate. The terminal elimination rate was planned estimated using linear regression on the terminal part of the time versus log(concentration) curve. A population-based method simultaneously estimating individual t½ values for all patients was applied, including patients with few values above the lower limit of quantification (LLOQ). This was estimated using time points from 1h to 30h. A chromogenic assay with PSS as calibrator was used.|2-6 weeks prior to initial dosing with N8-GP and up to 30 hours after administration of previous FVIII product|Results were based on FAS.|||hours||Geometric Coefficient of Variation|Geometric Mean
2643111|NCT01731600|Secondary|Area Under the Curve Evaluated for N8-GP|Area under the curve versus time from zero to infinity. This is calculated as AUC = AUClast + (C(t) / λz), where C(t) is the last measurable concentration. A chromogenic assay with product specific standard (PSS) as calibrator was used.|From 1 hour prior to and up to 96 hours after initial administration of N8-GP|Results were based on FAS.|||IU*h/mL||95% Confidence Interval|Least Squares Mean
2643112|NCT01731600|Secondary|Area Under the Curve Evaluated for Previous FVIII Product|Area under the curve (AUC) versus time from zero to infinity. This is calculated as AUC = AUClast + (C(t) / λz), where C(t) is the last measurable concentration. A chromogenic assay with NHP as calibrator was used.|2-6 weeks prior to initial dosing with N8-GP and up to 30 hours after administration of previous FVIII product|Results were based on FAS|||IU×h/mL||95% Confidence Interval|Least Squares Mean
2643113|NCT01731600|Secondary|Incremental Recovery (Defined as the Peak Level Recorded 60 Min After End of Injection) Evaluated for N8-GP|The incremental recovery was defined as the peak level recorded 60 min after end of injection and dose-normalised. It was calculated as (FVIII:C activity measured in plasma 60 min after dosing - FVIII:C activity measured in plasma immediately before dosing) / (dose injected at time 0 min), where the dose was expressed as U FVIII product per kg body weight. A chromogenic assay with product specific calibrator (PSS) as calibrator was used.|From 1 hour prior to and up to 96 hours after initial administration of N8-GP|Results were based on FAS.|||(IU/mL)/(U/kg)||95% Confidence Interval|Least Squares Mean
2643114|NCT01731600|Secondary|Incremental Recovery (Defined as the Peak Level Recorded 60 Min After End of Injection) Evaluated for Previous FVIII Product|The incremental recovery was defined as the increase in plasma FVIII activity per IU/kg of factor administered recorded 60 minutes after end of injection. It was calculated as (Factor VIII procoagulant [FVIII:C] activity measured in plasma 60 min after dosing - FVIII:C activity measured in plasma immediately before dosing) / (dose injected at time 0 min), where the dose was expressed as U FVIII product per kg body weight. A chromogenic assay with normal human plasma (NHP) as calibrator was used.|2-6 weeks prior to initial dosing with N8-GP and up to 30 hours after administration of previous FVIII product|Results were based on FAS.|||(IU/mL)/(U/kg)||95% Confidence Interval|Least Squares Mean
2643383|NCT01729208|Secondary|Number of Participants With Biomicroscopic Findings Greater Than Grade 2.|Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).|36 months||||participants|||Number
2643115|NCT01731600|Secondary|Consumption of N8-GP During Prophylaxis (U/kg Per Year)|The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed during prophylaxis (per year per subject). Consumption used for treatment includes all doses given (prophylaxis, treatment of bleed, minor surgery and pharmacokinetics)|Main phase: (from 0-26 weeks of treatment) and full trial: (0 weeks to last patient's completion of the trial, an average of 4.5 years)|Results were based on FAS.|||U/kg/year||Standard Deviation|Mean
2643116|NCT01731600|Secondary|Consumption of N8-GP During Prophylaxis (U/kg Per Month)|The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed during prophylaxis (per month per subject). Consumption used for treatment includes all doses given (prophylaxis, treatment of bleed, minor surgery and pharmacokinetics [PK])|Main phase: (from 0-26 weeks of treatment) and full trial: (0 weeks to last patient's completion of the trial, an average of 4.5 years)|Results were based on FAS.|||U/kg/month||Standard Deviation|Mean
2643117|NCT01731600|Secondary|Consumption of N8-GP During Prophylaxis (Number of Injections)|The mean number of injections of N8-GP used for treatment of a bleed from start to stop of a bleed during prophylaxis.|Main phase: (from 0-26 weeks of treatment) and full trial: (0 weeks to last patient's completion of the trial, an average of 4.5 years)|Results were based on FAS.|||Number of injections|Injections|Standard Deviation|Mean
2643118|NCT01731600|Secondary|Consumption of N8-GP Per Bleeding Episode (U/kg)|The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed.|Main phase: (from 0-26 weeks of treatment) and full trial: (0 weeks to last patient's completion of the trial, an average of 4.5 years)|Results were based on FAS.|||IU/kg/bleed|Bleeding episodes|Standard Deviation|Mean
2643119|NCT01731600|Secondary|Consumption of N8-GP Per Bleeding Episode (Number of Injections)|The mean number of injections of N8-GP used for treatment of a bleed from start to stop of a bleed.|Main phase: (from 0-26 weeks of treatment) and full trial: (0 weeks to last patient's completion of the trial, an average of 4.5 years)|Results were based on FAS.|||Number of injections|Bleeding episodes|Standard Deviation|Mean
2643120|NCT01731600|Secondary|Number of Bleeding Episodes During Prophylactic Treatment With N8-GP (Annualised Bleeding Rate)|The number of bleeding episodes per year reported during the prophylactic treatment with N8-GP.|Main phase: (from 0-26 weeks of treatment) and full trial: (0 weeks to last patient's completion of the trial, an average of 4.5 years)|Results were based on FAS.|||bleeds/patient/year||Inter-Quartile Range|Median
2643121|NCT01731600|Secondary|Haemostatic Effect of N8-GP When Used for Treatment of Bleeding Episodes and Assessed as: Excellent, Good, Moderate, or None|Haemostatic effect of N8-GP for treatment of bleeding episodes was assessed by 4-point response scale: none, moderate, good or excellent. Evaluation during trial was done by patient and/or parent(s)/caregiver 8 hours after first injection as follows: Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within approximately 8 hours after a single injection; Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after a single injection, but possibly requiring more than one injection for complete resolution; Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection, but usually requiring more than one injection; None: No improvement, or worsening of symptoms.|Main phase: (from 0-26 weeks of treatment) and full trial: (0 weeks to last patient's completion of the trial, an average of 4.5 years)|Results were based on full analysis set (FAS). All trial patients allocated to treatment, for which at least one of the pharmacokinetic or efficacy endpoints was assessed, were included in the FAS.|||Bleeding episodes|Bleeding episodes||Count of Units
2643122|NCT01731600|Secondary|Frequency of Adverse Events Including Serious Adverse Events Reported During the Trial Period|The frequency of adverse events including serious adverse events reported during the main and extension phase of the trial. The data presented is the rate of AE i.e. number of AEs per patient years of exposue.|Main phase: (from 0-26 weeks of treatment) and full trial: (0 weeks to last patient's completion of the trial, an average of 4.5 years)|Results were based on SAS.|||Events per patient years of exposure|||Number
2643123|NCT01731600|Primary|Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) ≥0.6 Bethesda Units|The number of participants with inhibitory antibodies against coagulation factor VIII (FVIII) ≥0.6 Bethesda units was presented.|During the main phase of the trial (from 0-26 weeks of treatment)|Results were based on safety analysis set (SAS). The SAS consists of all patients exposed to at least one dose of turoctocog alfa pegol. Number analysed = participants with minimum of 50 exposure days and developed inhibitory antibodies|||Participants|||Number
2643124|NCT01731470|Secondary|Change in Pain Scores at 4 and 8 Weeks Post-Treatment as Measured by the Visual Analog Scale (VAS)|Patients utilized the Visual Analog Scale (VAS) to describe their pain. The scale ranges from 0:No pain to 10: Pain as bad as it could possibly be.|4 and 8 weeks post-treatment||||units on a scale||Inter-Quartile Range|Mean
2643125|NCT01731470|Primary|Change in Symptom Severity at 4 and 8 Weeks Post-Treatment as Measured by the Total O'Leary-Sant IC Symptom and Problem Index (ICSI/ICPI) Score|The O'Leary-Sant IC Symptom Index (ICS-I) total score ranges from 0 to 20 and the Problem Index (ICP-I) total score ranges from 0 to 16. Each index has 4 questions and lower scores represent a better outcome. A total ICSI/ICPI score is obtained by adding the total scores from both indices. The combined ICSI/ICPI total score ranges from 0 to 36.|4 and 8 weeks post-treatment||||units on a scale||Inter-Quartile Range|Median
2643126|NCT01731171|Secondary|Mean Days Rehospitalized|This is the mean number of days rehospitalized for participants in each group during the study period.|Weeks 0 - 24 of study participation||||Days||Standard Deviation|Mean
2643127|NCT01731171|Secondary|Total Number of Rehospitalizations|This is a count of the number of rehospitalizations in each group during the study period.|Weeks 0 - 24 of study participation||||rehospitalizations|||Number
2643128|NCT01731171|Secondary|Number of Participants Rehospitalized|This is a count of the participants who had at least one rehospitalization during the study period.|Weeks 0 - 24 of study participation||||Participants|||Count of Participants
2643129|NCT01731171|Primary|Time to First Rehospitalization|The primary outcome was the time to first psychiatric inpatient rehospitalization.|Weeks 0 - 24 of study participation||||Days to first readmission||Inter-Quartile Range|Median
2643130|NCT01731119|Secondary|Overall Clinical Improvement|Overall psychiatric functioning will be assessed with the improvement (CGI-I) subscales of the CGI. CGI-I items are rated from 1 (very much improved) to 7 (very much worse).|Baseline to 12 weeks||||units on a scale||Standard Deviation|Mean
2643132|NCT01731119|Secondary|Changes in Efficacy Measures|Efficacy measures included the Aberrant Behavior Checklist-Community (ABC-C) total score which focuses on problem behaviors in five subdomains, including irritability, attention, repetitive behaviors, unusual speech, and social withdrawal. Differences in subdomains were not assessed. The ABC-C total score is the sum of 58 items, each rated among 0 = Not at all; 1 = Slight in degree; 2 = Moderately serious; and 3 = Severe in degree. The ABC-C total score ranges from 0 to 174. Higher values of ABC-C total scores represent greater severity of illness.|Baseline to 12 weeks||||units on a scale||95% Confidence Interval|Mean
2643133|NCT01731119|Secondary|Proportion of Participants Completing Treatment|Data will be collected on why participants terminated the study. If terminated early, the specific reason will be collected such as efficacy or tolerability.|12 weeks||||Participants|||Count of Participants
2643134|NCT01731119|Primary|Change in Weight|Change in weight from Baseline to Week 12 will be assessed as the primary outcome measure. Subjects will be asked to step on a special scale called a tanita which will calculate weight, fat mass at each study visit.|Baseline to 12 weeks||||lbs||95% Confidence Interval|Mean
2643135|NCT01731041|Secondary|P2Y12 Reaction Units (PRU) Determined by VerifyNow P2Y12|Secondary analysis included the differences of platelet reactivity expressed as P2Y12 reaction units (PRU) in each group using the VerifyNow P2Y12 system.|4 hours||||PRU||Standard Error|Least Squares Mean
2643136|NCT01731041|Primary|Platelet Reactivity Index (PRI) by Vasodilator-stimulated Phosphoprotein (VASP)|The primary end-point of the study is the comparison in the platelet reactivity index (PRI%) determined by vasodilator-stimulated phosphoprotein (VASP) between baseline and 4-hour after dosing in each arm of treatment|4 hours||||PRI%||Standard Error|Least Squares Mean
2643137|NCT01731002|Secondary|Extent of Exposure|Exposure to study medication in days for all treatment groups.|28 Days||||days||Standard Deviation|Mean
2643138|NCT01731002|Primary|Intraocular Pressure (IOP)|The primary efficacy endpoint was the mean IOP across subjects within treatment group on each day at each post-treatment timepoint. IOP was measured at 0800, 1000, and 1600 hours on days 0, 14, and 28. IOP was also measured at 0800 hours on Day 7 and follow-up days 29 and 30.|Study treatment was administered for 28 days|Modified intent to treat (mITT) population (3 subjects were excluded, leaving 221)|||mmHg||Standard Deviation|Mean
2643139|NCT01730950|Secondary|Number of Participants With Grade 3+ CNS Toxicity More Than 90 Days of Start of Radiation Therapy Reported as Possibly/Probably/Definitely Related to Protocol Treatment|Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Estimated using an exact binomial distribution together with 95% confidence interval. The difference between the two groups will be tested using a chi square test.|From 91 days after the start of radiation therapy to end of follow-up. Maximum follow-up at the time of analysis is 58.2 months.|Eligible participants on the radiation therapy arm who started radiation therapy and were alive at least 91 days from the start of radiation therapy|||Participants|||Count of Participants
2643140|NCT01730950|Secondary|Percentage of Participants With Grade 3+ Central Nervous System (CNS) Toxicity Within 90 Days of Start of Radiation Therapy Reported as Possibly/Probably/Definitely Related to Protocol Treatment|Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE.|From randomization to last follow-up. Maximum follow-up at time of analysis was 52.8 months.|Eligible participants on the radiation therapy arm who started radiation therapy|||percentage of participants||95% Confidence Interval|Number
2643141|NCT01730950|Secondary|Progression-free Survival|Progression using using MacDonald Criteria is defined as ≥ 25% increase from baseline in sum of products of the two largest perpendicular cross-sectional diameters of enhancing lesions (patient has not had steroid dose decreased since the last evaluation period); or any new lesions. A concomitant decrease in steroid dose rules out progression designation during initial 12 weeks after radiotherapy. Progression-free survival time is defined as time from randomization to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times will be compared between the arms, which is reported in the statistical analysis results. Eighteen-month rates are provided. Analysis was planned to occur when 135 deaths were reported.|From randomization to last follow-up. Maximum follow-up at time of analysis was 52.8 months.|Eligible participants|||percentage of participants||95% Confidence Interval|Number
2643142|NCT01730950|Secondary|Percentage of Participants Progression-free at 6 Months|"Best observed objective response determined by serial measures of the product of the two largest perpendicular cross-sectional diameters using MacDonald Criteria:~Progression (P): ≥ 25% increase in sum of products of enhancing lesions (patient has not had steroid dose decreased since the last evaluation period); or any new lesions. A concomitant decrease in steroid dose rules out progression designation during initial 12 weeks after radiotherapy. Progression-free at 6 months means patient alive without progression at 6 months."|From randomization to six months|Eligible participants with data at six months|||percentage of participants||95% Confidence Interval|Number
2643143|NCT01730950|Secondary|Percentage of Participants With Complete or Partial Best Response|"Best observed objective response determined by serial measures of the product of the two largest perpendicular cross-sectional diameters using MacDonald Criteria:~Complete Response (CR): complete disappearance of measurable enhancing lesion sustained ≥ 4 weeks; and no new lesions; and no corticosteroids.~Partial Response (PR): ≥ 50% decrease from baseline in sum of products of the measurable enhancing lesion sustained ≥ 4 weeks; and no new lesions; and stable/reduced corticosteroid dose.~Progression (P): ≥ 25% increase in sum of products of enhancing lesions (patient has not had steroid dose decreased since the last evaluation period); or any new lesions. A concomitant decrease in steroid dose rules out progression designation during initial 12 weeks after radiotherapy.~Stable Disease (SD): all of following: does not qualify for CR, PR, or P; receiving stable/decreasing doses of steroids.~Estimated using an exact binomial distribution."|From randomization to last follow-up. Maximum follow-up at time of analysis was 52.8 months.|Eligible participants with response evaluations|||percentage of participants||95% Confidence Interval|Number
2643144|NCT01730950|Primary|Overall Survival|Survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times will be compared between the arms, which is reported in the statistical analysis results. Eighteen-month rates are provided. Analysis was planned to occur when 135 deaths were reported.|From randomization to last follow-up. Maximum follow-up at time of analysis was 52.8 months.|Eligible participants|||percentage of participants||95% Confidence Interval|Number
2643145|NCT01730872|Secondary|Ocular Redness Change From Baseline to Day 6|Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness).|7 minutes post-CAC|The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.|||score on a scale||Standard Deviation|Mean
2643146|NCT01730872|Secondary|Ocular Itching Change From Baseline to Day 6|Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC|7 minutes post-CAC|The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.|||score on a scale||Standard Deviation|Mean
2643147|NCT01730872|Primary|Inflammation Change From Baseline to Day 6|Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation).|90 minutes post CAC|The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.|||score on a scale||Standard Deviation|Mean
2643148|NCT01730846|Secondary|Number of Cigarettes Smoked During Ad-lib Session|"Number of cigarettes smoked during the stress and neutral ad-lib smoking period.~Once the subject decides to smoke (delay period), the 1 hour ad-lib smoking period begins. They can chose to smoke as little or as much as they wish."|60 minutes (ad-lib smoking period)||||number of cigarettes||Standard Error|Mean
2643149|NCT01730846|Primary|Latency (Min) to Initiate Ad-lib Smoking Session|Latency to start smoking in the stress and neutral ad-lib smoking lab sessions. Subjects had the opportunity to delay smoking for 50 minutes (delay period). Once the subject decides to smoke, the 1 hour ad-lib smoking session begins. They can chose to smoke as little or as much as they wish.|0 up to 50 minutes (Delay Period)||||minutes||Standard Error|Mean
2643150|NCT01730729|Post-Hoc|Change in Serum Prolactin Levels From Baseline and After 2 Cycles of Treatment|Serum prolactin measurements were taken at baseline and after completion of two cycles of treatment. The mean drop was calculated for all patients, and for patients with best response of Stable Disease and Progressive Disease.|At baseline and after 2 cycles of treatment where 1 cycle =4 weeks|Serum prolactin at baseline and after 2 cycles of treatment were only available for 12 patients.|||ng/ml||Full Range|Mean
2643151|NCT01730729|Post-Hoc|Best Overall Response|"Best Overall Response is defined as patients best response to treatment from treatment initiation until the end of treatment as assessed by RECIST guidelines of CT scans.~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD.~Progressive Disease (PD): At least a 20% increase in the sum o the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LD since the treatment started"|From the start of treatment until the end of treatment up to a maximum of 20 cycles (1 cycle = 4 weeks)|1 patient died on treatment 7 days after starting and was not included in this outcome measure.|||Participants|||Count of Participants
2643152|NCT01730729|Post-Hoc|Disease Control at 12 Months|Number of patients without progressive disease as assessed by CT scan and RECIST guidelines at 12 months of treatment.|At 12 months from start of treatment||||Participants|||Count of Participants
2643153|NCT01730729|Post-Hoc|Clinical Benefit Rate (CBR) After 2 Cycles of Treatment|"Clinical Benefit Rate (CBR) is defined as the number of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and is assessed by RECIST guidelines for measurements of CT scan at 8 weeks (2 cycles) of treatment.~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD.~Progressive Disease (PD): At least a 20% increase in the sum o the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LD since the treatment started"|After 8 weeks (2 cycles) of treatment|2 patients did not reach the 8 week response assessment time point.|||Participants|||Count of Participants
2643154|NCT01730729|Secondary|Overall Survival (OS)|Overall Survival (OS) is defined from the first day of treatment until death from any cause.|From the start of treatment until death from any cause. Median follow up time of 6.817 months (95%CI 0.22-26.18)||||Months||95% Confidence Interval|Median
2643155|NCT01730729|Secondary|Correlate Tissue Prolactin Biomarkers With Response to Therapy|Baseline tumor tissue was analyzed for prolactin receptor (PRLr) expression and was provided with an IHC-based Allred score of 0 to 300 based on percentage intensity where lower scores indicate less PRLr expression and high scores indicate more PRLr expression. Only the malignant epithelium was scored. The score was correlated with best response of patient.|At baseline|Only 9 patients had sufficient baseline tissue to be analyzed.|||score on a scale||Full Range|Median
2643156|NCT01730729|Secondary|Change in Prolactin Receptor Expression Measurements at Baseline and After 1 Cycle|Evaluate prolactin expression in biopsy tissue taken at baseline and after 4 weeks (1 cycle) of treatment.|At baseline and after 4 weeks (1 cycle)|No data collected as no patients completed repeat biopsy after 1 cycle of treatment.||||||
2643157|NCT01730729|Secondary|Change in Within-patient Imaging Measurements at Baseline and After 2 Cycles|At baseline and after 2 cycles changes CT and bone scan measurements will be evaluated.|At baseline and at 8 weeks|This data was not collected and analysed as it was decided that it was not meaningful on its own.||||||
2643384|NCT01729208|Secondary|Number of Participants With Biomicroscopic Findings|Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).|24 months||||participants|||Number
2643158|NCT01730729|Secondary|Treatment Toxicity|"Toxicity will be assessed at the beginning of each cycle (1 cycle equals 28 days) during treatment and 30 days post last treatment during treatment. Toxicity will be assessed according to the National Cancer Institute's Common Toxicity Criteria for adverse events version 3.0 (CTCAE v3.0). In general adverse events (AEs) will be graded according to the following:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE Grades 1 through 4 adverse events that were determined to be at least possibly related to treatment are combined and reported below."|After every 4 weeks (1 cycle) during treatment for up to 20 cycles and 30 days post last treatment||||participants|||Number
2643159|NCT01730729|Secondary|Progression Free Survival (PFS)|Progression Free Survival (PFS) will be measured from time of treatment initiation until first documentation of progression of disease or death from any cause.|From start of treatment until progression of disease or death||||Months||95% Confidence Interval|Median
2643160|NCT01730729|Primary|Overall Response Rate (ORR) at 2 Months|"Overall Response Rate (ORR) is defined as the number of patients that achieved Complete Response (CR) or Partial Response (PR) and will be assessed after 8 weeks (2 cycles) of therapy using CT scan images and RECIST guidelines.~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum of LD.~Progressive Disease (PD): At least a 20% increase in the sum o the LD of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LD since the treatment started"|After 8 weeks (2 cycles) of treament|2 patients did not reach 8 week response time point and were determined not to be evaluable for this objective.|||Participants|||Count of Participants
2643161|NCT01730586|Secondary|Progression-Free Survival (PFS)|"The length of time during and after the treatment a participant lives without disease progression. Time to progression functions estimated using the Kaplan-Meier method. Participants who drop out of the study included in the time to event data analysis as censored data."|Assessed at first cycle (21 days), up to 12 months|For progression-free survival, the intent-to-treat analysis performed using all available participants.|||Months||95% Confidence Interval|Median
2643162|NCT01730586|Primary|Response Rate in CIMP-High Colorectal Cancer and Small Bowel Adenocarcinoma (SBA)|Evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) criteria (version 1.1, 2009): Complete Response (CR): Disappearance all lesions including normalization of elevated tumor marker level; Pathological lymph nodes reduction in short axis to <10 mm. Partial Response (PR): >30% decrease sum longest diameters (LD) of lesions reference baseline sum LD. Progressive Disease (PD): >20% increase (absolute increase >5 mm) in sum LD measured lesions references smallest sum LD, and appearance new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD. After a tumor demonstrates a tumor response (partial or complete), confirmation of the response obtained by a second evaluation to be performed 2 cycles later (+/- 1week) [second tumor assessment not <4 weeks from response observed]. Assessed via computed tomography (CT) of the chest, abdomen, and pelvis.|Assessed at 21 day cycle; Restaging done every 3 cycles|In the CIMP-CRC arm 15 participants were considered efficacy evaluable [Of 21 treated, 6 participants were withdrawn due to toxicity (2) and due to clinical progression (4)], and three were not evaluable in SBA arm.|||Participants|||Count of Participants
2643163|NCT01730534|Secondary|Subjects Included in the Endpoint of All-cause Mortality.|Secondary|up to 5.2 years||||Participants|||Count of Participants
2643164|NCT01730534|Secondary|Subjects Included in the Renal Composite Endpoint: Confirmed Sustained ≥40% Decrease in eGFR to eGFR <60 ml/Min/1.73m2 and/or ESRD and/or Renal or CV Death.|Secondary|up to 5.2 years||||Participants|||Count of Participants
2643165|NCT01730534|Primary|Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.|Co-primary efficacy|up to 5.2 years||||Participants|||Count of Participants
2643166|NCT01730534|Primary|Subjects Included in the Composite Endpoint of CV Death, MI or Ischemic Stroke|Safety and co-primary efficacy|up to 5.2 years||||Participants|||Count of Participants
2643167|NCT01730378|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (From Day 0 to 182)|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
2643168|NCT01730378|Secondary|Number of Subjects Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 63-day (Days 21-83) post-dose 2 in Prepandrix Group|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2643169|NCT01730378|Secondary|Number of Subjects Reporting Unsolicted AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 84-day (Days 0-83) post vaccination period|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
2643235|NCT01730040|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2643170|NCT01730378|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21 days (Day 0-20) post-vaccination period|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
2643171|NCT01730378|Secondary|Number of Subjects Reporting Any Potential Immune Mediated Diseases (pIMDs).|Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (From Day 0 to Day 182)|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
2643172|NCT01730378|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increased sweating and fever [axillary temperature above 38.0 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity as assessed by inability to attend/do work or school, or requires intervention of a physician/healthcare provider. Grade 3 fever = axillary temperature above 39.0°C|During the 7-day (Days 0-6) post-vaccination period|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
2643173|NCT01730378|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 7-day (Day 0-6) period after each vaccination|Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.|||Subjects|||Number
2643174|NCT01730378|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).|At Day 0 and Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2643175|NCT01730378|Secondary|Mean Geometric Increase (MGI) for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
2643176|NCT01730378|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.|A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2)and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2643177|NCT01730378|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).|At Days 0 and 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2643178|NCT01730378|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
2643179|NCT01730378|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2645028|NCT01714310|Secondary|Pulse|Heart rate in beats per minute.|Baseline through week 12.|Some participants discontinued as trial progressed.|||beats per minute.||Standard Error|Least Squares Mean
2643180|NCT01730378|Secondary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.|At Day 0 and Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2643181|NCT01730378|Secondary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|Antibody titers were expressed as Geometric mean titers (GMTs).|At Day 21|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2643182|NCT01730378|Primary|Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|Antibody titers were expressed as Geometric mean titers (GMTs).|At Day 0 and Day 42|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2643183|NCT01730378|Primary|Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.|At Day 42|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2643184|NCT01730378|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).|At Day 42|Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
2643185|NCT01730378|Primary|Number of Seroconverted Subjects for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.|A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 42|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.|||Subjects|||Number
2643186|NCT01730339|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse event are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs related to laboratory abnormalities are reported.|Baseline up to Week 24|Safety population included all participants who received at least 1 dose of investigational product.|||participants|||Number
2643187|NCT01730339|Other Pre-specified|Number of Participants With Treatment Emergent Adverse Events (AEs) of Special Interest|Treatment Emergent Adverse Events (AEs) of special interest included injection site erythema, maculopapular rash, pruritus, bronchospasm, dyspnea, cough, fever and diarrhea.|Baseline up to Week 24|"Safety population included all participants who received at least 1 dose of investigational product. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."|||participants|||Number
2643188|NCT01730339|Other Pre-specified|Number of Participants With Electrocardiogram Findings|Following parameters were assessed: heart rate, PR Interval, QRS Interval, QT Interval, and Fridericia's Correction Formula (QTcF) interval. Electrocardiogram Results were reported as normal, abnormal, not clinically significant (NCS) and abnormal and clinically significant (CS) as determined by investigator.|Baseline, Week 11|"Safety population included all participants who received at least 1 dose of investigational product. Here, n= participants who were evaluable at given time point for each arm, respectively."|||participants|||Number
2643189|NCT01730339|Other Pre-specified|Number of Participants With Abnormal Physical Examinations|Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), respiratory, cardiovascular, abdomen - liver and kidney, musculoskeletal, gastrointestinal, genitourinary, and neurological systems.|Baseline up to Week 24|Safety population included all participants who received at least 1 dose of investigational product.|||participants|||Number
2643190|NCT01730339|Other Pre-specified|Number of Participants With Clinically Significant Vital Sign Abnormalities|Vital Sign included pulse rate, systolic blood pressure, diastolic blood pressure, and weight.|Baseline up to Week 24|Safety population included all participants who received at least 1 dose of investigational product.|||participants|||Number
2643191|NCT01730339|Secondary|Physician and Participant Photoguide Scar Assessment Scale Score|Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Within participant treatment difference was assessed between the treatment regimens each participant received.|Week 8, 11, 18, 24|"mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here, n= participants who were evaluable at given time point for each arm, respectively."|||units on scale||Standard Error|Least Squares Mean
2643192|NCT01730339|Secondary|Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score|PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Participants completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0-100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity. Within participant treatment difference was assessed between the treatment regimens each participant received.|Week 8, 24|"mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here,n= participants who were evaluable at given time point for each arm, respectively."|||units on scale||Standard Error|Least Squares Mean
2643193|NCT01730339|Secondary|Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS)|Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin). Within participant treatment difference was assessed between the treatment regimens each participant received|Week 8, 11, 18, 24|"mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here, n= participants who were evaluable at given time point for each arm, respectively."|||units on scale||Standard Error|Least Squares Mean
2643194|NCT01730339|Secondary|Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)|Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable). Within participant treatment difference was assessed between the treatment regimens each participant received. Data for overall opinion scale score at Week 24 was not presented in this outcome measure because the data was reported separately under primary outcome measure 1.|Week 8, 11, 18, 24|"mITT population included all participants who were randomized and received at least 1 dose of investigational product. Here,n= participants who were evaluable at given time point for each arm, respectively."|||units on scale||Standard Error|Least Squares Mean
2643195|NCT01730339|Primary|Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS)|Physician global assessment was performed using the overall opinion question of the POSAS scale. Physicians were asked to rate the severity of the participant's scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). Within participant treatment difference was assessed between the treatment regimens each participant received.|Week 24|Modified Intent To Treat (mITT) population included all participants who were randomized and received at least 1 dose of investigational product. Here, N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||units on scale||Standard Error|Least Squares Mean
2643196|NCT01730053|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 12|Apo A-1 ITT population.|||percent change||Standard Error|Least Squares Mean
2643197|NCT01730053|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 12|Fasting triglycerides ITT population.|||percent change||Standard Error|Mean
2643198|NCT01730053|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 12|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2643199|NCT01730053|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 12|Lipoprotein (a) ITT population.|||percent change||Standard Error|Mean
2643200|NCT01730053|Secondary|Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2643201|NCT01730053|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population.|||percent change||Standard Error|Mean
2643202|NCT01730053|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2643203|NCT01730053|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population.|||percent change||Standard Error|Mean
2643385|NCT01729208|Secondary|Number of Participants With Biomicroscopic Findings Greater Than Grade 2|Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).|12 months||||participants|||Number
2643204|NCT01730053|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).|Up to Week 24|mITT population.|||percentage of participants|||Number
2643205|NCT01730053|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.|||percentage of participants|||Number
2643206|NCT01730053|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).|Up to Week 24|mITT population.|||percentage of participants|||Number
2643207|NCT01730053|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.|||percentage of participants|||Number
2643208|NCT01730053|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 12|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
2643209|NCT01730053|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 12|Non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2643210|NCT01730053|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 12|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
2643211|NCT01730053|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2643212|NCT01730053|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2643213|NCT01730053|Secondary|Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2643214|NCT01730053|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment.|||percent change||Standard Error|Least Squares Mean
2643215|NCT01730053|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2643216|NCT01730053|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).|From Baseline to Week 12|mITT population.|||percent change||Standard Error|Least Squares Mean
2643217|NCT01730053|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment (ITT analysis).|From Baseline to Week 12|ITT population.|||percent change||Standard Error|Least Squares Mean
2643218|NCT01730053|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2643219|NCT01730053|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2643220|NCT01730040|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo A-1 ITT population.|||percent change||Standard Error|Least Squares Mean
2643221|NCT01730040|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2643222|NCT01730040|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2643223|NCT01730040|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Lipoprotein (a) ITT population.|||percent change||Standard Error|Mean
2643224|NCT01730040|Secondary|Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2643225|NCT01730040|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population: all randomized and treated participants with one baseline and at least one post-baseline fasting triglycerides value on- or off-treatment.|||percent change||Standard Error|Mean
2643226|NCT01730040|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2643227|NCT01730040|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population.|||percent change||Standard Error|Mean
2643228|NCT01730040|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).|Up to Week 24|mITT population.|||percentage of participants|||Number
2643229|NCT01730040|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.|||percentage of participants|||Number
2643230|NCT01730040|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first (on-treatment analysis).|Up to Week 24|mITT population.|||percentage of participants|||Number
2643231|NCT01730040|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.|||percentage of participants|||Number
2643232|NCT01730040|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
2643236|NCT01730040|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2643237|NCT01730040|Secondary|Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2643238|NCT01730040|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (ie. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment.|||percent change||Standard Error|Least Squares Mean
2643239|NCT01730040|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2643240|NCT01730040|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).|From Baseline to Week 24|mITT population.|||percent change||Standard Error|Least Squares Mean
2643241|NCT01730040|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment (ITT analysis).|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
2643242|NCT01730040|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule [whatever atorvastatin, rosuvastatin or ezetimibe], whichever came first) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2643243|NCT01730040|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2643244|NCT01729923|Secondary|Relapse Free Survival in Patients Achieving CR|Relapse-free survival estimated using the Kaplan-Meier method based on the ITT population starting from the time of induction chemotherapy initiation.|Up to 5 years|Measure Description: Inclusive of subject still alive at time of last reporting Time Frame: Until last reported survival Study terminated; data not further analyzed|||months|||Number
2643245|NCT01729923|Secondary|Quality of Life (QOL), Assessed Using the M.D. Anderson Symptom Inventory (MDASI)|Group differences in QOL will be estimated, with repeated measures used to improve precision of estimates.|Up to 5 years|We have been unable to confirmation that the original Principal Investigator secured the appropriate permission to use this instrument. Therefore, we are unable to use the data.||||||
2643246|NCT01729923|Secondary|Overall Survival|Estimated using the Kaplan-Meier method based on the ITT population starting from the time of induction chemotherapy initiation until death or last reported survival.|Until death or last reported survival, up to 5 years||||months||Full Range|Median
2643247|NCT01729923|Secondary|K-ras Mutation Status|The relationship between K-ras mutation, resection, and radiation and response to ADAPT therapy will be evaluated using Chi-squared analysis and Cox regression analysis.|Up to 5 years|K-ras mutation status was not collected.||||||
2643248|NCT01729923|Secondary|Best Overall Response Rate Among All Patients Who Had RECIST Measurements at Baseline and at Least One Subsequent Occasion and Did Not Have Surgery or Radiation Therapy|RECIST 1.1 criteria will be used to measure changes in the size of a selected sentinel lesion for each patient. Computed tomographic images will be measured at baseline and at subsequent 9 week intervals. Changes will be measured as percentage of the baseline measure. Results will be reported as the largest negative change. For patients with no negative changes, results will be reported as the smallest positive change.|Serial measures at 9 week intervals up to 5 years|Patients who had RECIST measurements at baseline and at least one subsequent occasion and did not have surgery or radiation therapy|||percentage of baseline lesion size||Full Range|Mean
2643386|NCT01729208|Secondary|Number of Participants With Biomicroscopic Findings Greater Than Grade 2|Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe).|Baseline||||participants|||Number
2643387|NCT01729208|Primary|Change in Axial Length Relative to Baseline|Mean change in axial length measurement, in millimeters at 36 months, relative to baseline.|36 months||||mm|Eyes|Standard Deviation|Mean
2643249|NCT01729923|Secondary|Best Overall Response Rate Among All Patients Who Had RECIST Measurements at Baseline and at Least One Subsequent Occasion|RECIST 1.1 criteria will be used to measure changes in the size of a selected sentinel lesion for each patient. Computed tomographic images will be measured at baseline and at subsequent 9 week intervals. Changes will be measured as percentage of the baseline measure. Results will be reported as the largest negative change. For patients with no negative changes, results will be reported as the smallest positive change.|Serial measures at 9 week intervals up to 5 years|All patients who had RECIST measures at baseline and at least one other time point.|||percentage of baseline lesion size||Full Range|Mean
2643250|NCT01729923|Primary|Rate of CR, Assessed According to CEA and CA 19-9 Measurements and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1|Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor marker level in response to ADAPT therapy.|3 years||||Participants|||Count of Participants
2643251|NCT01729871|Secondary|Number of Participants With Vascular Death|Any death that was not clearly non-vascular. Examples of vascular death included deaths due to bleeding, Myocardial Infarction (MI), stroke, heart failure and arrhythmias.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.|||Participants|||Number
2643252|NCT01729871|Secondary|Number of Participants With Non-Central Nervous System (Non-CNS) Systemic Embolism|The Non-CNS systemic embolism was defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (example; trauma, atherosclerosis, instrumentation).|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.|||Participants|||Number
2643253|NCT01729871|Secondary|Number of Participants With Ischemic Stroke|Stroke was defined as a new, sudden, focal neurological deficit resulting from a presumed cerebrovascular cause that was not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or seizure.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.|||Participants|||Number
2643254|NCT01729871|Secondary|Number of Participants With Myocardial Infarction (MI)|The MI was defined as clinical symptoms consistent with myocardial ischemia and cardiac biomarker elevation greater than the site's upper limit of normal (ULN) or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram (ECG) or autopsy confirmation, OR Creatine kinase-muscle and brain subunit [or creatine kinase (CK) in the absence of CK-MB] greater than (>) 3 or 5 or 10 x ULN for samples obtained within 24 hours of the procedure if the baseline values were normal or at least a 50 percent (%) increase over elevated baseline values that were stable or decreasing or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram. Symptoms of cardiac ischemia were not required.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.|||Participants|||Number
2643255|NCT01729871|Secondary|Number of Participants With Composite Endpoint of Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism and Vascular Death|The composite endpoint include Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (non-CNS) Systemic Embolism and Vascular Death.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.|||Participants|||Number
2643256|NCT01729871|Primary|Number of Participants With Incidence of Post-Procedure Major Bleeding Events|Post-procedure major bleeding events include Thrombolysis in Myocardial Infarction (TIMI), International Society on Thrombosis and Haemostasis (ISTH) and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/life threatening bleeding.|Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure|Per-protocol analysis set included all randomized participants who took at least 1 dose of study drug and had undergone the catheter ablation procedure.|||Participants|||Number
2643257|NCT01729845|Secondary|Overall Survival|Survival measured as of day of last contact. Categorized according to criteria recommended by International Working Groups.|Up to 5 years|Population includes all Dose Level 2 participants, from both periods 1 and 2.|||days||Full Range|Median
2643258|NCT01729845|Secondary|Duration of Relapse-free Survival (for Patients Achieving CR or CRp)|Categorized according to criteria recommended by International Working Groups.|Up to 5 years|Population includes all Dose Level 2 participants, from both periods 1 and 2, who achieved CR or CRp|||Days||Full Range|Median
2643259|NCT01729845|Secondary|Remission Rate Including CR and CRp|"Complete remission (CR) and Complete remission with incomplete platelet recovery (CRp) categorized according to criteria recommended by International Working Groups:~Complete resolution of disease-related symptoms and signs including palpable hepatosplenomegaly; hemoglobin level at least 110 g/L, platelet count at least 100x10^9/L, and absolute neutrophil count at least 1.0 x10^9/L. In addition, all 3 blood counts should be no higher than the upper normal limit; Normal leukocyte differential; Bone marrow histologic remission defined as the presence of age-adjusted normocellularity, no more than 5% myeloblasts, and an osteomyelofibrosis grade no higher than 1."|Up to 5 years|Population includes all Dose Level 2 participants from both periods 1 and 2.|||Participants|||Count of Participants
2643260|NCT01729845|Primary|Most Efficacious and Tolerated Dosage of Decitabine (Period 1)|MTD (most tolerated dose) of decitabine, measured in number of dose limiting toxicities. MTD defined as the highest dose in which the incidence of dose limiting toxicity is < 33%, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (Phase I)|through day 45||||Incidents|||Number
2643271|NCT01729754|Secondary|Mean Change From Baseline in PASI Score Over Time (Part 2)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.|Baseline and Week 16, Week 22 or Week 28|Analysis population includes randomized participants who received at least one dose of study medication in Part 2 and with valid PASI value at baseline and at the time point for endpoint (ie, Weeks 16, 22 and 28).|||Scores on a scale||Standard Deviation|Mean
2643261|NCT01729819|Secondary|Change in the Impact on Sleep as Measured by the Sleep Rating Scales From Baseline|An electronic diary was used in the trial to document the impact on sleep quality (sleep rating scales). The sleep rating scales included three questions that ranged from 0 (poor) to 10 (good). The average of each question for each visit was summarised and the change from baseline was analysed longitudinally during the three months of treatment.|Baseline to 3 months of treatment|The FAS comprised of all randomised and exposed subjects with at least one efficacy assessment after treatment initiation. The FAS comprised of 97 subjects (45 in the combination group and 52 in the tolterodine group).|||Score on scale||95% Confidence Interval|Least Squares Mean
2643262|NCT01729819|Secondary|Onset of Effect as Seen in Change in Mean Number of Nocturnal Voids From Baseline for Each Visit During Three Months of Treatment|A nocturnal void was defined as a void occurring at least 5 minutes after going to bed, but before getting up the next morning. The mean estimate was the average over 3 consecutive 24-hour periods prior to the respective visit as captured in the voiding and sleep diary.|Baseline to 3 months of treatment|The FAS comprised of all randomised and exposed subjects with at least one efficacy assessment after treatment initiation. The FAS comprised of 97 subjects (45 in the combination group and 52 in the tolterodine group).|||Voids||95% Confidence Interval|Least Squares Mean
2643263|NCT01729819|Secondary|Responder Status|Responder status was defined as ≥33% decrease in the mean number of nocturnal void and at least one night with no voids out of the 3-day diary period.|Baseline to 3 months of treatment|The FAS comprised of all randomised and exposed subjects with at least one efficacy assessment after treatment initiation. The FAS comprised of 97 subjects (45 in the combination group and 52 in the tolterodine group).|||Proportion of responders|||Number
2643264|NCT01729819|Secondary|Change in Mean Nocturnal Urine Volume From Baseline|The mean nocturnal urine volume was derived from the three-day urine volume diary. The nocturnal volume was defined as the sum of the volumes for all nocturnal voids including the volume of the first morning void within 30 min of waking up in the morning.|Baseline to 3 months of treatment|The FAS comprised of all randomised and exposed subjects with at least one efficacy assessment after treatment initiation. The FAS comprised of 97 subjects (45 in the combination group and 52 in the tolterodine group).|||mL||95% Confidence Interval|Least Squares Mean
2643265|NCT01729819|Secondary|Change in Mean Time to First Nocturnal Void From Baseline|The time to first nocturnal void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in the case there is no nocturnal void. The time to first void was calculated as the average over three consecutive 24-hour periods prior to the respective visits.|Baseline to 3 months of treatment|The FAS comprised of all randomised and exposed subjects with at least one efficacy assessment after treatment initiation. The FAS comprised of 97 subjects (45 in the combination group and 52 in the tolterodine group).|||Minutes||95% Confidence Interval|Least Squares Mean
2643266|NCT01729819|Primary|Change in Mean Number of Nocturnal Voids From Baseline|A nocturnal void was defined as a void occurring at least 5 minutes after going to bed, but before getting up the next morning. The mean estimate was the average over 3 consecutive 24-hour periods prior to the respective visit as captured in the voiding and sleep diary.|Baseline to 3 months of treatment|The FAS comprised of all randomised and exposed subjects with at least one efficacy assessment after treatment initiation. The FAS comprised of 97 subjects (45 in the combination group and 52 in the tolterodine group).|||Voids||95% Confidence Interval|Least Squares Mean
2643267|NCT01729754|Secondary|Mean Percent Change From Baseline in PASI Score Over Time (Part 3)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52|Analysis population includes randomized participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at the time point for endpoint (ie, Weeks 32, 36, 40, 46 and 52).|||Percent change||Standard Deviation|Mean
2643268|NCT01729754|Secondary|Mean Percent Change From Baseline in PASI Score Over Time (Part 2)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.|Baseline and Week 16, Week 22 or Week 28|Analysis population includes randomized participants who received at least one dose of study medication in Part 2 and with valid PASI value at baseline and at the time point for endpoint (ie, Weeks 16, 22 and 28).|||Percent change||Standard Deviation|Mean
2643269|NCT01729754|Secondary|Mean Percent Change From Baseline in PASI Score Over Time (Part 1)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.|Baseline and Week 4, Week 8 or Week 12|Analysis population includes randomized participants who received at least one dose of study medication in Part 1 and with valid PASI value at baseline and at the time point for endpoint (ie, Weeks 4, 8 and 12).|||Percent change||Standard Deviation|Mean
2643270|NCT01729754|Secondary|Mean Change From Baseline in PASI Score Over Time (Part 3)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Baseline and Week 32, Week 36, Week 40, Week 46 and Week 52|Analysis population includes randomized participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at the time point for endpoint (ie, Weeks 32, 36, 40, 46 and 52).|||Scores on a scale||Standard Deviation|Mean
2643388|NCT01729208|Primary|Change in Axial Length Relative to Baseline|Mean change in axial length measurement, in millimeters at 24 months, relative to baseline.|24 months||||mm|Eyes|Standard Deviation|Mean
2643389|NCT01729208|Primary|Change in Axial Length Relative to Baseline|Mean change in axial length measurement, in millimeters at 12 months, relative to baseline.|12 months||||mm|Eyes|Standard Deviation|Mean
2643272|NCT01729754|Secondary|Mean Change From Baseline in PASI Score Over Time (Part 1)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status.|Baseline and Week 4, Week 8 or Week 12|Analysis population includes randomized participants who received at least one dose of study medication in Part 1 and with valid PASI value at baseline and at the time point for endpoint (ie, Weeks 4, 8 and 12).|||Scores on a scale||Standard Deviation|Mean
2643273|NCT01729754|Secondary|Percentage of Participants With a DLQI Score of 0 or 1 at Week 52 (Part 3)|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 52|Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at Week 52.|||Percentage of participants|||Number
2643274|NCT01729754|Secondary|Percentage of Participants With a DLQI Score of 0 or 1 at Week 40 (Part 3)|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 40|Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at Week 40.|||Percentage of participants|||Number
2643275|NCT01729754|Secondary|Percentage of Participants With a DLQI Score of 0 or 1 at Week 28 (Part 2)|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.|Week 28|Analysis population includes randomized participants to tildrakizumab 200 mg, tildrakizumab 100 mg or etanercept in Part 1, who received at least one dose of study medication in Part 2 and with a valid DLQI value at Week 28.|||Percentage of participants|||Number
2643276|NCT01729754|Secondary|Percentage of Participants With a DLQI Score of 0 or 1 at Week 12 (Part 1)|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.|Week 12|Analysis population includes randomized participants who received at least one dose of study medication in Part 1 and with a valid DLQI value at Week 12.|||Percentage of participants|||Number
2643277|NCT01729754|Secondary|Change From Baseline in the DLQI at Week 52 (Part 3)|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Baseline and Week 52|Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at baseline and Week 52.|||Score on a scale||Standard Deviation|Mean
2643278|NCT01729754|Secondary|Change From Baseline in the DLQI at Week 40 (Part 3)|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Baseline and Week 40|Participants who received at least one dose of study medication in Part 3 and with valid DLQI value at baseline and Week 40.|||Score on a scale||Standard Deviation|Mean
2643279|NCT01729754|Secondary|Change From Baseline in the DLQI at Week 28 (Part 2)|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.|Baseline and Week 28|Analysis population includes randomized participants who received at least one dose of study medication and with baseline or post-baseline DLQI values in Part 1 or Part 2.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2643280|NCT01729754|Secondary|Change From Baseline in the DLQI at Week 12 (Part 1)|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.|Baseline and Week 12|Analysis population includes randomized participants who received at least one dose of study medication with baseline or post-baseline DLQI values in Part 1.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2643281|NCT01729754|Secondary|Baseline Dermatology Life Quality Index (DLQI)|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.|Baseline|Analysis population includes randomized participants who received at least one dose of study medication with baseline and post-baseline DLQI values in Part 1.|||Score on a scale||Standard Deviation|Mean
2643299|NCT01729754|Primary|Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.|Week 12|Analysis population includes all randomized participants who received at least 1 dose of Part 1 study treatment based on the treatment assigned.|||Percentage of participants|||Number
2643282|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-100 Response at Week 52 (Part 3)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 52|Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52.|||Percentage of participants|||Number
2643283|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-100 Response at Week 40 (Part 3)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 40|Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40.|||Percentage of participants|||Number
2643284|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-100 Response at Week 28 (Part 2)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.|Week 28|Analysis population includes participants randomized to tildrakizumab 100 mg, tildrakizumab 200 mg, or etanercept in Part 1 who received at least one dose of study medication in study Part 2.|||Percentage of participants|||Number
2643285|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-100 Response at Week 12 (Part 1)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.|Week 12|Analysis population includes randomized participants who received at least one dose of study medication in study Part 1 and with valid PASI value at baseline and Week 12.|||Perentage of participants|||Number
2643286|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-90 Response at Week 52 (Part 3)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 52|Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52.|||Percentage of participants|||Number
2643287|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-90 Response at Week 40 (Part 3)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 40|Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40.|||Percentage of participants|||Number
2643288|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-90 Response at Week 28 (Part 2)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.|Week 28|Analysis population includes participants randomized to tildrakizumab 100 mg, tildrakizumab 200 mg, or etanercept in Part 1 who received at least one dose of study medication in study Part 2.|||Percentage of participants|||Number
2643289|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-90 Response at Week 12 (Part 1)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.|Week 12|Analysis population includes randomized participants who received at least one dose of study medication in study Part 1.|||Percentage of participants|||Number
2643290|NCT01729754|Secondary|Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 52 (Part 3)|The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 52|Participants who received at least one dose of study medication in Part 3 and with valid PGA value at baseline and at Week 52.|||Percentage of participants|||Number
2643291|NCT01729754|Secondary|Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 40 (Part 3)|The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 40|Participants who received at least one dose of study medication in Part 3 and with valid PGA value at baseline and at Week 40.|||Percentage of participants|||Number
2643292|NCT01729754|Secondary|Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 28 (Part 2)|The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.|Week 28|Analysis population includes participants randomized to tildrakizumab 100 mg, tildrakizumab 200 mg, or etanercept in Part 1 who received at least one dose of study medication in Part 2.|||Percentage of participants|||Number
2643293|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-75 Response at Week 52 (Part 3)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 52|Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52.|||Percentage of participants|||Number
2643294|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-75 Response at Week 40 (Part 3)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and <75% improvement in PASI response from baseline at Week 28.|Week 40|Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40.|||Percentage of participants|||Number
2643295|NCT01729754|Secondary|Percentage of Participants Achieving a PASI-75 Response at Week 28 (Part 2)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of involvement. Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. Primary analysis for this endpoint is for participants randomized to tildrakizumab 200 mg, tildrakizumab 100 mg, or etanercept in Part 1.|Week 28|Analysis population includes all participants randomized to tildrakizumab or etanercept in Part 1 who received at least one dose of study medication in Part 2.|||Percentage of participants|||Number
2643296|NCT01729754|Primary|Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 12|Analysis population includes participants who took at least one dose of Part 1 study medication based on the treatment actually received.|||Percentage of participants|||Number
2643297|NCT01729754|Primary|Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to Week 12|Analysis population includes participants who took at least one dose of Part 1 study drug based on the treatment actually received.|||Percentage of participants|||Number
2643298|NCT01729754|Primary|Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Part 1)|The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study.|Week 12|Analysis population includes all randomized participants who received at least 1 dose of Part 1 study treatment based on the treatment assigned.|||Percentage of participants|||Number
2643342|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Very Young Children (Age 2 to Less Than 3 Years).|Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|up to 15 hours|Pharmacokinetic Set|||nanogram per milliliter||Standard Deviation|Mean
2643300|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Triacylglycerol Lipase (TL) Enzyme Activity|A triacylglycerol lipase test was done to check for pancreatic function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to investigational medicinal product administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older Children N=27 at Visit 1 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data at visit)."|||U/L||Standard Deviation|Mean
2643301|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Alkaline Phosphatase (ALP) Enzyme Activity|The Alkaline Phosphatase activity was used to detect bone or hepatobiliary disease. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 2 and 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 3: N=16 one participant with missing data at this visit)."|||U/L||Standard Deviation|Mean
2643302|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Creatine Kinase (CK) Enzyme Activity|The creatine kinase (CK) test was used to detect inflammation of muscles. The test was done in combination with other tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children at Visit 1: N=27 (1 participant missing); Young and Very Young Children Group at Visit 3: N=16 one participant with missing data at this visit)."|||U/L||Standard Deviation|Mean
2643303|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Protein Concentration|The test was done to verify kidney and liver function. It is done in combination with the albumin test. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older Children at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||g/L||Standard Deviation|Mean
2643304|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Liver Function Test - Lactate Dehydrogenase (LDH) Enzyme Activity|Lactate Dehydrogenase (LDH) was used to check for tissue damage. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older Children at Visits 1 and 3: N=26 and at Visit 2 N=24 participants; Young and Very Young Children Group at Visits 1 and 3: N=16 participant with missing data)."|||U/L||Standard Deviation|Mean
2643305|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Liver Function Test - Bilirubin Concentration|Old red blood cells are replaced by new blood cells every day. Bilirubin is made by the body when the old blood cells are removed. The concentration of bilirubin in the blood measures liver function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents-Visit 2 & 3: N=20 - 1 participant with data missing; Older Children-Visit 1 & 2: N=26 thus 2 participants with data missing; Young and Very Young Children-Visits 1 & 3: N=12 (5 with data missing) & at Visit 2 N=9 (8 with data missing)."|||µmol/L||Standard Deviation|Mean
2643306|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Liver Function Test - Gamma-Glutamyl Transferase (GGT) Enzyme Activity|The gamma-glutamyl transferase (GGT) test was used in combination with the alkaline phosphatase (ALP) test. Both ALP and GGT can be elevated in bile duct or liver complications. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 2 and 3: N=20 one participant with missing data; Older Children at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 2: N=16 one participant with missing data)."|||U/L||Standard Deviation|Mean
2643307|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Liver Function Test - Alanine Aminotransferase (ALT) Enzyme Activity|This test was done in combination with other tests (such as AST, ALP, and bilirubin) to diagnose and monitor the liver function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit, Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=19 two participants with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||U/L||Standard Deviation|Mean
2643308|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Urine pH (Acid, Alkalinity) Test|A urine sample was tested right away. A dipstick made with a color-sensitive pad was used. The color indicated the acidity of the urine. In the study there were 2 planned safety urine collections. At Visit 1 in the enrollment period, after consent and assent obtained. The second sample was obtained at Visit 3 prior to discharge from the hospital. The discharge visit was as per standard of care.|Enrollment Visit and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Young and Very Young Children Group at Visits 1: N=9 thus 8 participants with missing data; at Visit 3: N=7 thus 10 participants with missing data)."|||units on a scale||Standard Deviation|Mean
2643309|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Urine Specific Gravity|This test was used to test for the water balance and urine concentration. A urine sample was tested right away. A dipstick with a color-sensitive pad was used. The color the dipstick changes and the specific gravity of the urine was read off the color chart. In the study there were 2 planned safety urine collections. At Visit 1 in the enrollment period, after consent and assent obtained. The second sample was obtained at Visit 3 prior to discharge from the hospital. The discharge visit was as per standard of care.|Enrollment Visit and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Young and Very Young Children Group at Visits 1: N=9 thus 8 participants with missing data; at Visit 3: N=7 thus 10 participants with missing data)."|||units on a scale||Standard Deviation|Mean
2643310|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Calculated Glomerular Filtration Rate|Glomerular filtration rate (GFR) was done to check how well the kidneys are working. It estimates how much blood passes through the glomeruli in the kidney each minute. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||mL/min/1.73m^2||Standard Deviation|Mean
2643311|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Urate in the Blood|Uric acid (urate is the salt) is a chemical created when the body breaks down substances called purines. Most urate dissolves in blood and travels to the kidneys. From there, it passes out in the urine. The test is used to determine kidney function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||µmol/L||Standard Deviation|Mean
2643312|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Serum Albumin Concentration|Albumin is a protein made by the liver. Albumin prevents fluid leaking into the tissues. Albumin also transports many small molecules. Serum albumin was measured in the clear liquid portion of the blood called serum. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children N=27 at Visit 1; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||g/L||Standard Deviation|Mean
2643313|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Triglycerides Concentration|Triglycerides are a group of fat. Triglycerides were measured as part of metabolic and cardiac assessments. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant data missing; Older children Visits 2 and 3: N=27 and N=26 one and two participant data missing; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant data missing)."|||mmol/L||Standard Deviation|Mean
2643314|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Aspartate Aminotransferase (AST) Enzyme Activity|AST is considered to be one of the two most important tests to detect liver injury. During liver damage the enzyme is released into the blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children at Visits 2 and 3: N=26 two participants with missing data; Young and Very Young Children Group at Visits 1 and 3: N=16 one participant with missing data)."|||U/L||Standard Deviation|Mean
2643315|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Creatinine Concentration|Creatinine is removed from the body entirely by the kidneys. If kidney function is not normal, creatinine level increases in the blood. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||µmol/L||Standard Deviation|Mean
2643390|NCT01729208|Primary|Change in Refractive Error Relative to Baseline|Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline.|36 months||||Diopters|Eyes|Standard Deviation|Mean
2643316|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Urea Nitrogen (BUN) Concentration|This test is to measure the amount of urea nitrogen in the blood. It was used to test liver and kidney function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||mmol/L||Standard Deviation|Mean
2643317|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Phosphate Concentration|Phosphate is needed by the body. This test was done to see how much phosphate is in the blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||mmol/L||Standard Deviation|Mean
2643318|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Chloride Concentration|Chloride with other electrolytes help keep the proper balance of body fluids and maintain the body's acid-base balance. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children Group at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||mmol/L||Standard Deviation|Mean
2643319|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Calcium Concentration|All cells need calcium in order to function. In the study there were 3 planned safety blood draws for routine blood tests. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Older children Group at Visit 2: N=27 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||mmol/L||Standard Deviation|Mean
2643320|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Potassium Concentration|Potassium is a mineral that the body needs to work normally. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||mmol/L||Standard Deviation|Mean
2643321|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Sodium Concentration|Sodium is required by the body for the body to function properly. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||mmol/L||Standard Deviation|Mean
2643322|NCT01729728|Secondary|Biochemistry Safety Laboratory Parameters: Blood Glucose Concentration|A blood glucose test measures the amount of a sugar called glucose in blood. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visit 3: N=16 one participant with missing data)."|||mmol/L||Standard Deviation|Mean
2643323|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Leukocyte Concentration|Leukocytes are also called white blood cells (WBC). These were measured to assess immune function. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each visit)."|||GI/L||Standard Deviation|Mean
2643324|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Platelet Count|Platelets are cell fragments that are vital for normal blood clotting. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits)."|||GI/L||Standard Deviation|Mean
2643325|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Erythrocyte Mean Corpuscular Volume (Mean Corpuscular Volume)|Erythrocyte Mean Corpuscular volume is a measurement of the average size of Red Blood Cells (RBC). It is also referred to as Mean Corpuscular Volume. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits)."|||fL||Standard Deviation|Mean
2643326|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Hematocrit|Hematocrit is a blood test that measures the percentage of the volume of whole blood that is made up of red blood cells (RBC). This measurement depends on the number of red blood cells and the size of red blood cells. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits)."|||fraction of blood volume||Standard Deviation|Mean
2643327|NCT01729728|Secondary|Hematology Safety Laboratory Assessments: Hemoglobin Concentration|The hemoglobin test is a commonly ordered blood test and was done as part of a complete blood count (CBC). It is routinely done before and after surgery to check for anemia, the presence of chronic kidney disease or other chronic medical problems. In the study there were 3 planned safety blood draws for routine blood tests: at Visit 1 (during the enrollment period, including surgery), at Visit 2 (prior to study drug administration) and at Visit 3 (prior to discharge from the hospital). The discharge visit was as per standard of care.|Enrollment Visit; Visit 2 and Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at Visit 3: N=20 one participant with missing data; Young and Very Young Children Group at Visits 2 and 3: N=16 one participant with missing data at each of these visits)."|||g/L||Standard Deviation|Mean
2643328|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter: Time to Maximum Concentration (Tmax) of Tapentadol-O-glucuronide After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18).|"Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age. The time to maximum concentration is derived from the area under the curve from dose to 15 hours (AUC 0-15). The Tmax is the time after dosing at which the maximum concentration of the tapentadol-O-glucuronide (metabolite) occurs. Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.|||hours||Standard Deviation|Mean
2643329|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter: Cmax (Maximum Concentration) of Tapentadol-O-glucuronide After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).|"Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol-O-glucuronide (metabolite) is assessed to study absorption and distribution.~The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of metabolite observed in the blood sample."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.|||nanogramsg/millilitre||Standard Error|Mean
2643330|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter of Tapentadol-O-glucuronide Area Under the Concentration-Time Curve (AUC 0-15) After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).|"Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.~Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol (active drug) is assessed during absorption and distribution.~The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of active drug observed in the blood sample."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.|||ng*hr/mL||Full Range|Mean
2643331|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter: Time to Maximum Concentration (Tmax) of Tapentadol After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).|"Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.~The time to maximum concentration is derived from the area under the curve from dose to 15 hours (AUC 0-15). The Tmax is the time after dosing at which the maximum concentration of the tapentadol (active drug) occurs.~Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.|||hours||Standard Deviation|Mean
2643332|NCT01729728|Secondary|Intake of Additional Analgesic Medication During the Trial|Number of participants with intakes of supplemental analgesic medication between investigational medicinal product (IMP) intake and Site Discharge grouped according to preparation taken (non-opioid/opioid).|Baseline; 15 hours post dosing|The protocol pre-specified that the young and very young children will be reported as one group.|||participants|||Number
2643376|NCT01729247|Secondary|Number of Participants Correctly Categorized by True Level of Airway Inflammation|Assessment of airway inflamation was performed by an allergist or nurse practioner/physicians assistant prior to knowledge of forced exhaled nitric oxide (FeNO) results. Airway inflamation was categorized as low, intermediate or high. A summary of the number of participants with correctly identified airway inflammation assessments by the physician for each true level of inflammation are displayed below.|Study visit (single visit study) approximately 1 hour.||||participants correctly categorized|||Number
2643333|NCT01729728|Secondary|Treatment Emergent Adverse Events by Intensity|"The intensity of all treatment emergent adverse events (TEAEs) were scored by the investigator. Treatment emergent adverse events were those adverse events documented from the time of investigational medicinal product (IMP), study drug, up to 48 hours post dosing.~The clinical intensity of an adverse event was classified as:~Mild: Signs and symptoms that can be easily tolerated. Symptoms can be ignored and disappear when the subject is distracted.~Moderate: Symptoms cause discomfort but are tolerable; they cannot be ignored and affect concentration.~Severe: Symptoms which affect usual daily activity.~For adverse events where the intensity changes over time, the maximum intensity observed was documented."|Baseline; 48 hours post dosing|The protocol pre-specified that the young and very young children will be reported as one group.|||number of events|||Number
2643334|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter: Cmax (Maximum Concentration) of Tapentadol After a Single Dose of Tapentadol in Adolescents (Age 12 to Less Than 18 Years).|"Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.~Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours. The concentration of tapentadol (active drug) is assessed during absorption and distribution.~The maximum concentration is derived from the Area Under the Curve, from dose to 15 hours (AUC 0-15). It is the highest amount of active drug observed in the blood sample"|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.|||nanograms/millilitre||Standard Error|Mean
2643335|NCT01729728|Secondary|Change From Enrollment in 12-lead Electrocardiogram Heart Rate Parameter|"12-lead Electrocardiograms (ECG) were part of the planned safety assessments. 12-lead Electrocardiograms were performed prior at the enrollment visit after informed consent and at the discharge visit. The discharge visit was as per standard of care.~The changes in heart rate (beats per minute) parameters are reported per treatment group between the visits.~A positive value indicates that the heart rate was higher at discharge than at enrollment."|Enrollment; Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(For older children: N=27 at Visit 1)"|||beats per minute||Standard Deviation|Mean
2643336|NCT01729728|Secondary|Change From Enrollment in 12-lead Electrocardiogram Parameters|"12-lead electrocardiograms (ECG) were part of the planned safety assessments. 12-lead Electrocardiograms were performed prior at the enrollment visit after informed consent and at the discharge visit. The discharge visit was as per standard of care.~The changes in ECG parameters are reported. Negative mean values indicate that the millisecond intervals decreased from the enrollment to the discharge visit. Positive mean values indicate that the millisecond intervals increased from the enrollment to the discharge visit. The Letters P,Q,R,S and T refer to specific medically defined points on an ECG tracing and correspond to specific heart activities."|Enrollment (pre-surgery); Discharge Visit|"The protocol pre-specified that the young and very young children will be reported as one group.~(For older children N=27 at Visit 1)"|||milliseconds||Standard Deviation|Mean
2643337|NCT01729728|Secondary|Systolic and Diastolic Blood Pressure Assessments|"Systolic and Diastolic blood pressure assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.~Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1)."|Enrollment Visit; 15 hours post-dose|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at and after 2 hours: N=20; Older Children Group at 30 minutes and 1 hour N=27, at 2 hours N=24, at and after 4 hours N=22; Young and Very Young Children Group at and after 4 hours: N=16)."|||mmHg||Standard Deviation|Mean
2643338|NCT01729728|Secondary|Oxygen Saturation Assessments|"Oxygen saturation assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.~Oxygen saturation was assessed using pulse oximetry. The uppermost value is 100%.~Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1)."|Enrollment Visit; 15 hours post-dose|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at and after 2 hours: N=20; Older Children Group at 30 minutes and 1 hour N=27, at 2 hours N=24, at and after 4 hours N=22; Young and Very Young Children Group at and after 4 hours: N=16)."|||percentage of oxygen saturation||Standard Deviation|Mean
2643339|NCT01729728|Secondary|Respiratory Rate Assessments|"Respiratory rate assessments were performed at pre-defined times during the 15 hour period following investigational medicinal product intake.~Pre-surgery data for these participants is also given from the enrollment Visit (Visit 1)."|Enrollment Visit; 15 hours post-dose|"The protocol pre-specified that the young and very young children will be reported as one group.~(Adolescents Group at and after 2 hours: N=20; Older Children Group at 30 minutes and 1 hour N=27, at 2 hours N=24, and at and after 4 hours N=22; Young and Very Young Children Group at and after 4 hours: N=16)."|||breaths per minute||Standard Deviation|Mean
2643340|NCT01729728|Primary|Non-Compartmental Pharmacokinetic (PK) Parameter of Tapentadol Area Under the Concentration-Time Curve (AUC 0-15) After a Single Dose of Tapentadol in Adolescent Participants (Age 12 to Less Than 18 Years).|"Serum samples for pharmacokinetic analysis were obtained using frequent sampling techniques in participants 12 years to less than 18 years of age.~Serum samples (frequent sampling) were drawn at 0.25, 0.5, 1, 2, 4, 6, 11, and 15 hours.~The Area Under the Curve (AUC) from dose to 15 hours (AUC 0-15) is a summary measure of data from each pharmacokinetic blood sample taken over the 15 hour time period.~The area is that below the line fitted to the data points."|up to 15 hours|The protocol planned that this analysis would only be performed for the adolescent participants.|||ng*hr/mL||Full Range|Mean
2643341|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Very Young Children (Age 2 to Less Than 3 Years).|"Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL."|up to 15 hours|Pharmacokinetic Set|||nanogram per milliliter||Standard Deviation|Mean
2643391|NCT01729208|Primary|Change in Refractive Error Relative to Baseline|Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 24 months, relative to baseline.|24 months||||Diopters|Eyes|Standard Deviation|Mean
2643343|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Younger Children (Age 3 to Less Than 6 Years).|"Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL."|up to 15 hours|Pharmacokinetic Set|||nanogram per milliliter||Standard Deviation|Mean
2643344|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Younger Children (Age 3 to Less Than 6 Years).|Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|up to 15 hours||||nanogram per milliliter||Standard Deviation|Mean
2643345|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Older Children (Age 6 to Less Than 12 Years).|"Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL."|up to 15 hours|Pharmacokinetic Set|||nanogram per milliliter||Standard Deviation|Mean
2643346|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Older Children (Age 6 to Less Than 12 Years).|Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|up to 15 hours||||nanogram per milliliter||Standard Deviation|Mean
2643347|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years).|"Mean and Standard Deviation of Serum Concentrations of Tapentadol-O-glucuronide. Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that it can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 10 ng/mL."|up to 15 hours|Pharmacokinetic Set|||nanogram per milliliter||Standard Deviation|Mean
2643348|NCT01729728|Secondary|Sum of Pain Intensity Differences Over the 4 Hours After Dosing Derived From the Different Pain Scales and for All Age Groups|"Different pain intensity assessment tools were used in the different age groups. Therefore the sum of pain intensities were calculated and are reported for each age group based on the tool used.~Adolescents - Age 12 to Less Than 18 Years.~Older Children - Age 6 to Less Than 12 Years.~Young Children - Age 3 to Less Than 6 Years.~Very Young Children - Age 2 to Less Than 3 Years.~CAS (McGrath color analog scale) [Theoretical Range: -40 to + 40],~VAS (100 mm Visual Analog Scale) [Theoretical Range: -400 to + 400],~FPS-R (6-point Faces Pain Scale - Revised) [Theoretical Range: -40 to + 40],~FLACC (Face, Legs, Activity, Cry, and Consolability score) [Theoretical Range: -40 to + 40].~A mean score of zero indicates that there was no pain intensity change over the 4 hours.~The positive values indicate that in the group as a whole the sum of all pain intensity values over the first 4 hours lead to a reduction in pain in the time period."|Baseline; 4 hours post-dose|Protocol pre-specified reporting groups.|||units on a scale||Standard Deviation|Mean
2643349|NCT01729728|Secondary|Pain Intensity Assessment Using the Face, Legs, Activity, Cry, Consolability Scale in Young and Very Young Children (Age 2 to Less Than 6 Years).|The Face Legs Activity Cry Consolability (FLACC) Scale was developed by the Department of Anesthesiology, University of Michigan Medical School and Health Systems. The FLACC Scale is a behavioral scale for scoring postoperative pain in children between the ages of two months and seven years or in persons unable to communicate. In this trial the scale was used in the young and very young children, i.e. in participants aged 2 to less than 6 years. This tool includes five categories of pain behaviors, including facial expression, leg movement, activity, cry, and consolability. The clinician observes the participant for 5 minutes or more and scores each category with a 0, 1 or 2. The scores are added together for a total score ranging from 0 (no pain) to 10 (worst pain). The higher the total score the higher the pain.|Baseline; 15 hours post-dose|The protocol pre-specified that the young and very young children will be reported as one group.|||units on a scale||Standard Deviation|Mean
2643350|NCT01729728|Secondary|Pain Intensity Assessments Using the Faces Pain Scale (Revised) in Children Age 3 to Less Than 12 Years.|"This assessment tool was used in 3 to less than 12 year old participants, i.e. Older Children and Young Children.~The Faces Pain Scale (Revised) [FPS-R] score as allocated to a selected face by the participant. There are 6 faces and the participant is asked to indicate on a face to express how much it hurts.~The numeric value 0 (no pain) to 10 (very much pain) is read off the reverse side of the scale by the clinician."|Baseline; 15 hours post-dose|The protocol pre-specified that the Faces Pain Scale (Revised) would not be administered in the very young participants (aged 2 to less than 3 years).|||units on a scale||Standard Deviation|Mean
2643351|NCT01729728|Secondary|Pain Intensity Assessments Using the McGrath Color Analog Scale in Adolescent Participants and Older Children (Age 6 to Less Than 18 Years).|Pain intensity assessments were with a 0 (no pain) to 10 (worst pain) scored McGrath color analog scale (CAS) in participants aged 6 years to less than 18 years, i.e. in Adolescents and Older Children. Participants were presented with the CAS and instructed to place the sliding bar on the color that best represented their pain intensity level at the time of assessment. The CAS is a pocket size tool used to measure the self-reported pain intensity of the older participants. The CAS consists of a 145 mm long triangular shaped strip of plastic, varying in width and hue from 1 mm wide and light pink hue at the bottom (and text no pain), to 3 mm wide and deep red hue at the top (most pain). This instrument includes 2 sides. One side shows the color pain intensity scale as described and the other shows a graduated scale, which provides a specific numeric value for the participant-reported level of pain.|Baseline; 15 hours post-dose|Protocol pre-specified reporting groups.|||units on a scale||Standard Deviation|Mean
2643352|NCT01729728|Secondary|Pain Intensity Assessments Using the Visual Analog Scale (VAS) in Adolescents (Age 12 to Less Than 18 Years).|"At predefined times after investigational medicinal product administration, participants were asked to rate their pain on a 100 mm line (visual analog scale - VAS) by marking a point on the line in response to:~My pain at this time is. The mark was scored between no pain and  pain as bad as it could be. The distance was then measured by a clinician and reported.~A value of 0 indicates no pain. A value of 100 indicates pain as bad as it could be."|Baseline; 15 hours|Protocol pre-specified reporting groups.|||units on a scale||Standard Deviation|Mean
2643353|NCT01729728|Primary|Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years).|Mean and Standard Deviation of Serum Concentrations of Tapentadol. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|up to 15 hours|Pharmacokinetic Set|||nanogram per milliliter||Standard Deviation|Mean
2643354|NCT01729598|Secondary|Change in Cerebrospinal Fluid Clusterin Levels (pg/ml)|Change in cerebrospinal fluid clusterin levels (pg/ml) from baseline to end of treatment (Day 28)|Baseline and day 28||||pg/ml||Standard Deviation|Mean
2643355|NCT01729598|Secondary|Change in Free & Cued Selective Reminding Test- Free Recall (Number of Items Correct)|Change in Free & Cued Selective Reminding Test- delayed free recall from baseline to end of treatment (Day 28)|Baseline and day 28||||number of items recalled||Standard Deviation|Mean
2643356|NCT01729598|Secondary|Change in Cerebrospinal Fluid P-tau Levels (pg/ml)|Change in cerebrospinal fluid p181-tau levels (pg/ml) from baseline to end of treatment (Day 28)|Baseline and day 28||||pg/ml||Standard Deviation|Mean
2643357|NCT01729598|Primary|Change in Cerebrospinal Fluid Amyloid Levels (pg/ml) Over 28 Day Intervention Period by Study Arm|Change in cerebrospinal fluid amyloid-beta 1-42 levels in pg/ml from baseline to end of treatment (day 28)|Baseline and day 28||||pg/ml||Standard Deviation|Mean
2643358|NCT01729598|Primary|Frequency of Adverse Events Over the Duration of the Study by Study Arm|Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, physical examinations, and clinical laboratory tests throughout the study. The incidence of observed toxicities and adverse events will be tabulated, the frequencies compared in participants who receive active medication and those who receive placebo, and reviewed for potential significance and clinical importance.|Day 35||||Participants|||Count of Participants
2643359|NCT01729559|Secondary|Heparin Induced Thrombocytopenia|The possible occurrence of heparin induced thrombocytopenia (HIT) was investigated when any patient (in either low molecular weight heparin [LMWH] or low dose unfractionated heparin [LDUH] study arm) had a platelet count drop of ≥50% (from a baseline value at the time of initiation of VTE prophylaxis) between day 5 and 14 following initiation of chemoprophylaxis per American College of Chest Physicians (ACCP) guidelines.|Within 30 of admission to hospital||||participants|||Number
2643360|NCT01729559|Secondary|Bleeding Event|Bleeding events will be classified by the Graafsma et al. severity of bleeding criteria (Major, Minor or No Bleeding). A major bleeding event will be defined as any overt bleeding following initiation of chemoprophylaxis associated with one or more of the following; a decrease in hemoglobin of ≥2 g/dL, bleeding leading to a transfusion of ≥2 units of packed red blood cells, a new retroperitoneal or intracranial bleed, or bleeding that warranted cessation of chemoprophylaxis treatment. Minor bleeding is defined as clinically evident bleeding not meeting criteria for major bleeding.|Within 30 days of admission to hospital||||participants|||Number
2643361|NCT01729559|Primary|Pulmonary Embolus|Patients with any or all of the following signs and symptoms suggestive of pulmonary embolism will have a CT angiogram (CTA) performed for diagnosis: Sudden onset of dyspnea, deterioration of existing dyspnea, decreased oxygen saturation (<92%), onset of pleuritic chest pain without another apparent cause, onset of tachycardia (>100), evidence of hypoxemia, hypocapnia, or respiratory alkalosis on arterial blood gas, or electrocardiographic changes reflecting right ventricular strain.|Within 30 days from admission to hospital||||participants|||Number
2643362|NCT01729559|Primary|Lower Extremity Deep Vein Thrombosis|Patients will have a bilateral lower extremity duplex ultrasound performed by a registered vascular technologist twice per week if the patient is in the ICU, or once per week if the patient is on the trauma ward. All of the deep veins from the external iliac to and including the calf veins will be interrogated. Diagnosis of deep vein thrombosis (DVT) will be defined as absence of complete vein compressibility, presence of an echogenic thrombus within the vein, absence of color flow characteristics including lack of spontaneity, phasicity, pulsatility and augmentability as noted in the clinical practice guidelines of the American Thoracic Society. The vascular technologist and physician reading the ultrasound study will be blinded to the patient's enrollment status and randomization arm/medication group.|Within 30 days of hospital admission||||percentage of patients|||Number
2643363|NCT01729338|Secondary|Risk Score as Assessed Using the Cancer and Leukemia Group B (CALGB) Geriatric Assessment Tool|Calculation of the risk score requires that the patient be assessed with the CALGB Assessment Tool, which has both a patient self-reporting questionnaire and a clinician assessment. Both will be used in this trial, and thus patients will have risk scores based on their own self-assessments and risk scores based on the clinicians' assessment. The risk score ranges from 0-19, with 0-5 indicating low risk, 6-9 intermediate risk, and 10-19 high risk. The distribution of the risk score in this trial will be described by plotting the median of the risk score against time, with patient and clinician assessments overlaid on the same plot.|Day 1|Data for the risk score wasn’t recorded correctly, and therefore we were unable to analyze the data.||||||
2643377|NCT01729247|Secondary|Physician Assessment of Airway Inflammation|Assessment of airway inflammation was performed by an allergist or nurse practitioner/physicians assistant prior to knowledge of forced exhaled nitric oxide (FeNO) results. Airway inflammation was categorized as low, intermediate or high. Mean FeNO results were summarized by the physicians assessment of airway inflammation (low, intermediate, high, or unsure).|Study visit (single visit study) approximately 1 hour||||parts per billion (ppb)||Standard Deviation|Mean
2643378|NCT01729247|Primary|FeNO Categorical Levels by ICS Use|Fractional exhaled nitric oxide (FeNO) is measured using a NIOX MINO device. FeNO measurements were categorized into low (<25 ppb), intermediate (>=25 to <=50 ppb) and high (>50 ppb). Number of participants falling into FeNO categories were then categorized as those that used inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA) and those who did not use ICS or ICS/LABA.|Study visit (single visit study). Approximately1 hour.||||participants|||Number
2643364|NCT01729338|Secondary|Functionality as Assessed Using the Cancer and Leukemia Group B (CALGB) Geriatric Assessment Tool|"Mean functionality in study subjects, quantitatively scored using the standardized and validated Cancer and Leukemia Group B (CALGB) Geriatric Assessment Tool, which comprehensively assesses aspects of a patient's functionality such as symptoms (e.g., pain, anxiety), social support (e.g., someone to turn to for help), and ability to carry out routine activities (e.g., grocery shopping) or physical exertion (e.g., climbing stairs) was assessed at baseline.~The score is obtained by inserting patient-specific data into the online calculator found at http://www.mycarg.org/Chemo_Toxicity_Calculator, which is based on the risk score described in Hurria A, Togawa K, Mohile SG, et al. Predicting chemotherapy toxicity in older adults with cancer: a prospective multicenter study. J Clin Oncol. 2011;29(25):3457-3465.~The risk score ranges from 0-19, with 0-5 indicating low risk, 6-9 intermediate risk, and 10-19 high risk for severe (grade >2) toxicity."|baseline|Participants who completed functionality assessment at baseline. Data were incompletely and irregularly collected after baseline so unable to analyze additional time points.|||Scores on a scale||Standard Deviation|Mean
2643365|NCT01729338|Secondary|QLQ-C30 Question 30|"Measured as mean quality of life in study subjects, quantitatively scored using the standardized and validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Question 30: How would you rate your overall quality of life during the past week?~7 point scores are standardized to a scale of 0-100, where 100 means highest possible quality."|baseline, 3 months, 5 months|Participants who completed questionnaire.|||units on a scale||Standard Deviation|Mean
2643366|NCT01729338|Secondary|QLQ-C30 Question 29|Measured as mean quality of life in study subjects, quantitatively scored using the standardized and validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Question 29: how would you rate your overall health during the past week? 7 point scores are standardized to a scale of 0-100, where 100 means highest possible quality.|baseline, 3 months, 5 months|Participants who completed questionnaire.|||units on a scale||Standard Deviation|Mean
2643367|NCT01729338|Secondary|Median Overall Survival|Defined as median time elapsed in study subjects between initiation of study therapy and death, regardless of cause.|Up to 3 years||||months||Standard Deviation|Median
2643368|NCT01729338|Secondary|Median Progression-free Survival|Defined as median time elapsed in study subjects between initiation of study therapy and either disease progression or death, regardless of cause of death.|4 years||||months||Standard Deviation|Median
2643369|NCT01729338|Secondary|Median Duration of Response|Defined as median time elapsed in study subjects between achievement of response and disease progression.|From date of first confirmed response until date of disease progression or up to 3 years|9 out of all patients achieved response and hence could be analyzed for duration of response|||months||Standard Deviation|Median
2643370|NCT01729338|Secondary|Median Time to Response|Defined as median time to achievement of response (partial remission or better by International Myeloma Working Group standard criteria), in study subjects during 8 months of induction chemotherapy.|Up to 8 months||||months||Standard Deviation|Median
2643371|NCT01729338|Secondary|Maximum Depth of Response During Maintenance Therapy|"Defined as maximum depth of response (ranging from partial response to complete response by International Myeloma Working Group (IMWG) criteria at any point during post-induction maintenance therapy.~IMWG: Complete Response (CR): negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; stringent CR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; Very Good Partial Response: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; Partial Response (PR): ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour. Stable disease mean that the patient has not achieved CR, VGPR, PR or progressive disease."|Up to 3 years|8 of all subjects reached maintenance and could be analyzed|||percentage of participants|||Number
2643372|NCT01729338|Secondary|Maximum Depth of Response During Induction Therapy|Maximum depth of response is defined as: ranging from partial response to complete response by International Myeloma Working Group (IMWG). Described as number of patients achieving each level of response. IMWG: CR: negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; sCR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; PR: ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour. Stable disease mean that the patient has not achieved CR, VGPR, PR or progressive disease.|Up to 8 months||||percentage of participants|||Number
2643373|NCT01729338|Secondary|Severe Adverse Event Rate|Defined as number of patients experiencing any grade or severe (≥ grade 3 by common toxicity criteria for adverse events (CTCAE) v4.0 criteria) adverse events at any time during the study|Up to 3 years||||percentage of participants|||Number
2643374|NCT01729338|Primary|Overall Response Rate (ORR) During Induction Therapy|"Defined as percentage of patients achieving a partial response or better by International Myeloma Working Group (IMWG) standard criteria:~IMWG: Complete Response (CR): negative immunofixation on the serum and urine, no soft tissue plasmacytomas and <5% plasma cells in the bone marrow; stringent CR: CR+normal free light chain ratio, no clonal cells in bone marrow by immunohistochemistry or immunofluorescence; Very Good Partial Response: serum and urine M-protein detected by immunofixation but not electrophoresis, >90% in serum M-protein+urine, M-protein level <100 mg/24hour; Partial Response (PR): ≥50% decrease of serum and M-protein, 24 hour urinary M-protein decrease by ≥90% or <200 mg/24hour."|Up to 8 months||||percentage of participants|||Number
2643375|NCT01729247|Secondary|Asthma Management Changes After FeNO Results Were Considered|Assessment of airway inflammation was performed by an allergist or nurse practitioner/physicians assistant prior to knowledge of fractional exhaled nitric oxide (FeNO) results. Airway inflammation was categorized as low, intermediate or high. Based on these assessments asthma medications were prescribed (prior to knowledge of FeNO results). Following the initial prescriptions, the physicians were informed of FeNO results, and any changes to asthma medication prescriptions were recorded. Asthma medications included short-acting beta-agonist (SABA), inhaled corticosteroid (ICS), ICS/long-acting beta-agonist (LABA), leukotriene receptor antagonist (LTRA), and oral corticosteroid (OCS).|Study visit (single visit study). Approximately1 hour.||||participants|||Number
2643400|NCT01729039|Secondary|10 Meter Walk Test|This measure assesses walking speed over a short distance. Subjects were asked to walk at their preferred gait speed for a distance of 30 feet which allowed 5 feet for acceleration and deceleration at the beginning and end of the walk. The time it took to walk 20 feet was recorded using a calibrated stopwatch and gait speed (ft/s) was calculated.|6 weeks||||ft/s||Standard Deviation|Mean
2643401|NCT01729039|Secondary|Activities-specific Balance Confidence Scale|As a result of their disequilibrium, subjects report decreased confidence that they can maintain their balance in a variety of situations. The Activities-specific balance confidence scale (ABC) was developed to measure the subject's confidence with their balance across a range of 16 activities of increasing challenge. Items are rated on a rating scale that ranges from 0 - 100% with a score of zero representing no confidence and a score of 100 representing complete confidence. An overall score is calculated by averaging the items with higher scores indicating higher (better) balance confidence.|6 weeks||||percentage||Standard Deviation|Mean
2643402|NCT01729039|Secondary|Dynamic Gait Index|The dynamic gait index (DGI) assesses an individual's ability to modify balance while walking in the presence of external demands. The 8 items of the DGI include walking while changing speed and turning the head, walking over and around obstacles, and stair climbing. Scoring of the DGI is based on a 4-point scale from 0 to 3 with 0 indicating severe impairment and 3 indicating normal ability. A maximum total score of 24 is possible and scores of < 20 indicate high risk for falling.|6 weeks||||units on a scale||Standard Deviation|Mean
2643403|NCT01729039|Primary|Visual Analog Scale - Disequilibrium|This scale was used to measure perceived level of unsteadiness while walking. This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of unsteadiness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived unsteadiness.|6 weeks|Repeated Measure (RM) ANOVA|||units on a scale||Standard Deviation|Mean
2643404|NCT01729039|Primary|Visual Analog Scale - Head Movement|This scale was used to measure perceived level of dizziness after one minute of horizontal head movement at 1 hertz (Hz). This technique uses a 10-cm line with one end being no symptoms (score = 0) and the other representing the worse possible symptoms (score = 10) and is commonly used to assess perception of pain. The subject is asked to place a mark on the 10-cm line at a point which indicates the intensity of his/her perception of symptoms of dizziness and the distance along that line is measured. Scores range from 0 to 10 with higher scores indicating worse perceived dizziness.|6 weeks||||units on a scale||Standard Deviation|Mean
2643405|NCT01729026|Secondary|Numeric Rating Scale for Pain Intensity|Self-rating scale that assesses pain severity|Baseline and 3-month and 6-month follow-up|||||||
2643406|NCT01729026|Secondary|Veterans RAND 12-item Health Survey (VR-12)|Self-rating scale that assess physical and mental aspects of health-related quality of life|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up|||||||
2643407|NCT01729026|Secondary|UCLA Loneliness Scale, Version 3|Self-rating scale to assess symptoms of loneliness|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up|||||||
2643408|NCT01729026|Secondary|Semi-Structured Interview|Interview that asks open-ended questions to assess the subject's symptoms, quality of life, and experiences related to having a dog|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up visits, as well as 2-week, 2-month, and 4.5-month phone calls|||||||
2643409|NCT01729026|Secondary|Pittsburgh Sleep Quality Inventory With PTSD Addendum (PSQI-A)|Self-rating scale that assesses the frequency and severity of various sleep-related problems, including problems that frequently occur in persons with PTSD|Baseline and 3-month and 6-month follow-up|||||||
2643410|NCT01729026|Secondary|Physical Activity Questionnaire (PAQ)|Self-rating scale that assesses the frequency and intensity of various types of physical activity over the previous 3 months.|Baseline and 3-month and 6-month follow-up|||||||
2643411|NCT01729026|Secondary|Patient Health Questionnaire-9 (PHQ-9)|Self-rating scale that assesses the presence and severity of the symptoms of a DSM-IV major depressive episode|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up|||||||
2643412|NCT01729026|Secondary|MINI International Neuropsychiatric Inventory (MINI)|Semi-structured interview used to assess the presence of 15 common DSM-IV psychiatric diagnoses.|Baseline|||||||
2643413|NCT01729026|Secondary|Community Integration Questionnaire (CIQ)|Self-rating scale that assesses the extent of a subject's integration into her or his community|Baseline and 3-month and 6-month follow-up visits|||||||
2643414|NCT01729026|Secondary|Beck Depression Inventory - II (BDI-II)|Self-rating scale that assesses the frequency and severity of common symptoms of depression|Baseline and 1-month, 3-month, 4-month, and 6-month follow-up|||||||
2643415|NCT01729026|Secondary|Alcohol Use Disorders Identification Test (AUDIT-C)|Self-rating scale that assesses the frequency and extent of alcohol use|Baseline and 1-month, 3-month, 4-month, and 6-month follow-ups|||||||
2643416|NCT01729026|Secondary|Clinician-Administered PTSD Scale for DSM-5 (CAPS)|The administration of the CAPS will ensure that participants meet criteria for current PTSD|The CAPS will be administered at the baseline, 3-month, and 6-month follow-ups.|||||||
2643417|NCT01729026|Primary|Change in PTSD Checklist (PCL-5) Score Between Baseline and 3-month Follow-up|PCL-5 a self rating scale based on the DSM-5 diagnostic criteria. The range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).|Baseline and 3-month follow-up visit.||||units on a scale||Standard Error|Mean
2643418|NCT01728805|Secondary|Pruritis Evaluation|"The Itchy QoL is a validated pruritus specific quality of life instrument. It includes 22 pruritus-specific questions covering three major domains: symptoms, functioning, and emotions. The scale ranges from Never (1) to All The Time (5). The subscale scores consist of the average of the responses to the items in a given subscale. The overall score is the average of the responses to all items. Higher Itchy QoL scores indicate worse quality of life.~LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate."|Cycle 1, 3, and 5|The number of participants analyzed were subjects with values at baseline and post-baseline.|||score on a scale||95% Confidence Interval|Least Squares Mean
2643419|NCT01728805|Secondary|Quality of Life (QoL) Assessment - Skindex-29 Symptoms Scale Score|"Skindex-29 rates 29 items assessing 3 domains (emotions, symptoms, & functioning) on a linear scale from 0 (never) to all the time (100). Higher scores = higher impact of skin disease.~FACT-G rates 27 items in 4 domains (physical well-being, social/family well-being, emotional well-being, functional well-being) on a 5-point scale from 0 (not at all) to 4 (very much). Higher scores = better QoL.~EuroQoL lvl 3 (Eq-5D-3L) rates mobility, self-care, usual activities, pain/discomfort and anxiety/depression on 3 levels - no problems, some problems, extreme problems. Score is calculated using a set of item weights to derive a single score ranging from -0.109 to 1, with 1 representing full health.~LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate."|Cycle 1, 3, and 5|The number of subjects analyzed in each row is the number of subjects with values at baseline and the specified post-baseline timepoint.|||score on a scale||95% Confidence Interval|Least Squares Mean
2643420|NCT01728805|Secondary|Overall Response Rate|The ORR was defined as the count of subjects who had a confirmed CR or PR, defined as documented CR or PR per Global Composite Response Score that was confirmed by a subsequent observation at least 4 weeks later. Overall Response Rate was determined based on the response in all compartments (lymph nodes, skin, peripheral blood, and viscera), referencing Olsen, 2011 as follows: Complete Response (CR) = complete disappearance of all clinical evidence of disease; Partial Response (PR) = regression of measurable disease; Stable Disease (SD) = failure to attain CR, PR, or PD; Progressive Disease (PD) = PD in any compartment; Relapse = recurrence of disease in prior CR in any compartment.|at the end of cycle 1 (26-28 days), and then every other cycle in Year 1 (cycle 3, 5, 7, 9, 11, 13), and every 16 weeks (cycle 17, 21, etc.) in Year 2 and beyond until progression up to 36 months|The total number of patients analyzed are further broken out by disease type [mycosis fungoides (MF) and Sezary Syndrome (SS)]|||Participants|||Count of Participants
2643421|NCT01728805|Primary|Progression Free Survival|"Progression was defined as follows, based on Olsen (2011):~Lymph nodes: ≥ 50% increase in SPD from baseline of lymph nodes, any new node > 1.5 cm in the long axis or > 1 cm in the short axis if 1-1.5 cm in the long axis that is proven to be N3 histologically, or > 50% increase from nadir in SPD of lymph nodes in those with PR~Skin: ≥ 25% increase in skin disease from baseline, new tumors (T3) in patients with T1, T2 or T4 only skin disease, or in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score~Blood: B0 to B2, > 50% increase from baseline and at least 5,000 neoplastic cells/μL36, or > 50% increase from nadir and at least 5,000 neoplastic cells/μL~Viscera: > 50% increase in size (SPD) of any organs involved at baseline, new organ involvement, or > 50% increase from nadir in the size (SPD) of any previous organ involvement in those with PR"|From date of randomization at every visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months||||percentage of subjects||95% Confidence Interval|Number
2643422|NCT01728792|Secondary|Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes||Days 28, 90 and 120 after 1st vaccination|Protocol deviations results in testing not performed for outcome measure.||||||
2643423|NCT01728792|Secondary|Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations|"Viral RNA was assessed for the four dengue components: Dengue-1 (TDV-1), Dengue-2 (TDV-2), Dengue-3 (TDV-3) and Dengue-4 (TDV-4). Only those time-points where at least 1 participant had Viral RNA detected are reported. Baseline (Day 0) and Day 7 are added for reference. n in each of the categories is the number of participants with data available."|Days 0, 7, 9, 11, 14, 17, 21, 90, 97 and 104|Participants from the Safety Analysis Set, all enrolled participants who received at least 1 dose of study vaccine, with data available at the given time-point.|||participants|||Number
2643424|NCT01728792|Primary|Seroconversion Rate to Each of Four Dengue Serotypes|Seroconversion rate was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plaques (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.|Approximately 28 to 30 days after each vaccination (Up to Day 30 and/or Day 104)|Protocol deviations results in testing not performed for outcome measure.||||||
2643425|NCT01728792|Primary|Number of Participants With at Least 1 Serious Adverse Event During the Study|"An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.~A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant."|First Vaccination to End of Study (Up to Day 120)|Safety Analysis Set includes all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.|||participants|||Number
2643426|NCT01728792|Primary|Number of Participants With at Least 1 Unsolicited Related Adverse Event Following Either Vaccine Dose|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The investigator assessed whether the AE was related to the study vaccination.|For 30 days after each vaccination for non-serious AEs and through the end of the study for SAEs (Up to 120 Days)|Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.|||participants|||Number
2643464|NCT01728376|Primary|Number of Participants With One or More Adverse Events (AEs)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Administration of first dose through the last follow-up visit (up to 77 days)|Participants who received any dose of IV study medication|||Participants|||Number
2643465|NCT01728337|Secondary|Maximum Evoked Compound Muscle Action Potential|To evaluate the duration, magnitude and peak of effects of two BT-A preparations, by measuring of the maximum Evoked Compound Muscle Action Potentials after contraction.|5 months after the procedure.|All subjects have received both treatments.|||mV||Standard Deviation|Mean
2643427|NCT01728792|Primary|Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity|Solicited systemic AEs were recorded by the participant into a memory aid for 14 days following each vaccination. Solicited systemic AEs included: headache, muscle pain (myalgia), joint pain (arthralgia), eye pain, sensitivity to light (photophobia), tiredness (fatigue), body rash, nausea and vomiting. Systemic AEs were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial where: Grade 0=none to Grade 4=severe. A systemic AE of fever (defined as ≥ 100.4°F) was derived from a daily temperature reading recorded in the memory aid. Solicited systemic AEs are presented as the number of participants reporting the event, by, AE, overall and by severity, using the participant's worst reported severity grade. Group 3 participants received 2 doses 90 days apart; systemic AEs following either vaccination are combined.|For 14 days after each vaccination (Up to Day 14 and/or Day 104)|Participants from the Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.|||participants|||Number
2643428|NCT01728792|Primary|Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity|Injection site reactions were recorded by the participant in a memory aid for 14 days following each injection. Participants measured and recorded the longest diameter of redness (erythema) or swelling (edema) using the scale: 0=< 2.5 cm to 3= Severe: > 10 cm. For pain and itching they recorded intensity grade: 0=not present, 1=mild, 2=moderate or 3=severe. Participant-recorded local reactions are presented as number of participants reporting a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only those score categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.|For 14 days after each vaccination (Up to Day 14 and/or Day 104)|Participants from the Safety Analysis Set, all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.|||participants|||Number
2643429|NCT01728792|Primary|Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator|Injection site reactions were evaluated by the investigator within 14 days following each injection. Erythema (redness), edema (swelling/induration) and pain were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Pain was graded from 0=None to 4=Life-threatening. Erythema and Edema longest diameter were graded using the scale: 0=<2.5 centimeters (cm) to 3=Severe: >10 cm. Itching was graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where: Grade 0=no itching to Grade 3=severe. Injection site reactions are presented as the number of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.|For 14 days after each vaccination (Up to Day 14 and/or Day 104)|Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.|||participants|||Number
2643430|NCT01728584|Secondary|Number of Participants Using Pain/Analgesic Medication During Post Operative Period: By Treatment Arm|Post operative use of pain/analgesic medication by participant through Day 8 was recorded.|Up to Day 8|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.|||participants using pain medication|||Number
2643431|NCT01728584|Secondary|Participant's Daily Assessment of Shoulder Pain During Post Operative Period: By Treatment Arm|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of shoulder pain for the study days following the surgery.|Days 2 to 8|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.|||score on a scale||Standard Deviation|Mean
2643432|NCT01728584|Secondary|Participant's Daily Assessment of Provoked Pain During Post Operative Period: By Treatment Arm|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of provoked pain for the study days following the surgery.|Days 2 to 8|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.|||score on a scale||Standard Deviation|Mean
2643433|NCT01728584|Secondary|Participant's Daily Assessment of Overall Pain at Rest During Post Operative Period: By Treatment Arm|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily (in the morning) from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. This measure summarizes the assessment of overall pain at rest for the study days following the surgery.|Days 2 to 8|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.|||score on a scale||Standard Deviation|Mean
2643469|NCT01728324|Secondary|SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.|Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT.|4 weeks (after End Of Treatment)|FAS|||percentage of participants||95% Confidence Interval|Number
2643434|NCT01728584|Secondary|Number of Participants With Rescue Actions Performed During Surgery in Order to Improve Insufficient Surgical Conditions: By Treatment Arm|"During procedure, surgeon (who was blinded to random assignment) could request that unblinded anesthetist change the randomized treatment conditions (called a rescue intervention), if surgeon considered surgical conditions to be unacceptable. This was to be done systematically as follows: If the participant is on standard NMB, the preferred rescue intervention should be to increase the NMB to a depth of 1-2 PTCs; for such a participant the second option (if participant is also on low insufflation pressure) should be the increase of insufflation pressure by 4 mm Hg. If the participant is already on deep NMB, the preferred option should be (if participant is also on low insufflation pressure) the increase of insufflation pressure by 4 mm Hg. The unblinded anesthetist recorded any rescue actions performed. This measure presents the number of participants: with any rescue action performed, with rescue change in depth of NMB, with rescue change in insufflation pressure level."|During surgery, approximate duration of 1-2 hours (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.|||participants|||Number
2643435|NCT01728584|Secondary|Score on Surgeon's Assessment of the Effect Participant's Movements During Surgery Had on the Overall Surgical Procedure: By Depth of NMB (Standard, Deep)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (extremely disruptive) to 10 (not disruptive): How did the patient movements described above disrupt your surgical performance? This refers to participant movements during surgery."|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.|||score on a scale||95% Confidence Interval|Least Squares Mean
2643436|NCT01728584|Secondary|Number of Times Participant's Movements or Increased Muscle Tone Interfered With the Surgical Conditions During Laparoscopy: By Depth of NMB (Standard, Deep)|"At the end of the procedure the surgeon responds to the following question: How many times did patient's movements (coughing, bucking, hiccup) or increased muscle tone (resistance, difficulty to close fasciae or skin) interfere with your surgery?"|During surgery, approximate duration of 1-2 hours (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.|||instances of occurrence that interfered||95% Confidence Interval|Least Squares Mean
2643437|NCT01728584|Secondary|Score on Surgeon's Assessment of the Overall Adequacy of Insufflation Pressure During Surgery: By Depth of NMB (Standard, Deep)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable insufflation pressure, required intervention) to 10 (excellent): How do you rate the overall adequacy of insufflation pressure during the surgery you just performed?"|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.|||score on a scale||95% Confidence Interval|Least Squares Mean
2643438|NCT01728584|Secondary|Score on Surgeon's Assessment of the Overall Adequacy of Muscle Relaxation During Surgery: By Depth of NMB (Standard, Deep)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable muscle relaxation, required intervention) to 10 (excellent): How do you rate the overall adequacy of muscle relaxation during the surgery you just performed?"|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.|||score on a scale||95% Confidence Interval|Least Squares Mean
2643439|NCT01728584|Secondary|Score on Surgeon's Assessment of Overall Satisfaction With the Visibility of the Surgical Field: By Depth of NMB (Standard, Deep)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable visibility) to 10 (excellent): How satisfied were you overall with the visual field during the surgery you just performed? If at any time the surgeon requests a rescue intervention, the surgeon will rate his overall satisfaction with the visibility of the surgical field according to his opinion, but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis."|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.|||score on a scale||95% Confidence Interval|Least Squares Mean
2643440|NCT01728584|Secondary|Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Treatment Arm|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. The participant's overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.|Up to 24 hours after administration of sugammadex on Day 1|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex, and did not convert to open surgery before NMB and/or pressure. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.|||score on a scale||95% Confidence Interval|Least Squares Mean
2643470|NCT01728324|Primary|Comparisons of SVR12 Rates Across Treatment Arms|Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.|12 Week (post-treatment)|FAS|||Percentage of participants||95% Confidence Interval|Number
2643981|NCT01722331|Primary|Number of Participants Experiencing an Adverse Event (Extension Study)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 212 weeks (including 20-week follow-up)||2020-10-31|10/2020||||
2643441|NCT01728584|Secondary|Participant's Overall Average Pain Score in the First 24 Hours After Administration of Sugammadex: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)|Participants rated pain at 1, 2, 4, 24 and 48 hours after the administration of sugammadex on day of surgery (Day 1), and daily from Day 3 to Day 8. Pain rating was made using an 11-point scale from 0 (no pain) to 10 (severe pain). Separate ratings were made for overall pain at rest, pain when provoked (e.g., due to participant transition from lying to sitting position) and shoulder pain at rest. The participant's overall average pain score within 24 hours after sugammadex was the average of all pain assessments (including all 3 pain types assessed) at 1, 2, 4 and 24 hours after sugammadex dose.|Up to 24 hours after administration of sugammadex on Day 1|Randomized participants with available data who had NMB or pneumoperitoneum for laparoscopic surgery, or received sugammadex, and did not convert to open surgery before NMB and/or pressure. Participants were included in arm corresponding to treatment actually received, which in case of rescue intervention was the post-intervention condition.|||score on a scale||95% Confidence Interval|Least Squares Mean
2643442|NCT01728584|Primary|Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Treatment Arm|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed? If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention). The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis."|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.|||score on a acale||95% Confidence Interval|Least Squares Mean
2643443|NCT01728584|Primary|Score on Surgeon's Assessment of Overall Satisfaction With the Surgical Conditions: By Depth of NMB (Standard, Deep) and Insufflation Pressure (Standard, Low)|"At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed? If at any time the surgeon requests a rescue intervention, the overall assessment of surgical conditions should be rated as 0 (=poor, needed intervention). The surgeon will rate the surgical conditions according to his opinion but if a rescue intervention has been applied, that individual participant will be counted with a score of zero in the analysis."|End of surgery (Day 1)|Randomized participants with available data who had NMB and pneumoperitoneum for laparoscopic surgery, and did not convert to open surgery before NMB and/or pressure application. Participants were included in the treatment arm to which they were randomized.|||score on a scale||95% Confidence Interval|Least Squares Mean
2643444|NCT01728454|Secondary|Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS)|"NRS is a valid and reliable clinical measure to assess pain intensity. Sex Avoidance Pain (SAP) and Endometriosis Pain (EP) were assessed using NRS-11 to measure pain based on pain ratings given by participants on the scale of 0 to 10 where, 0 represents no pain and 10 represents the worst pain possible. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement."|Baseline (28-day Baseline Menstrual Cycle) to the last day dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and to the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)|ITT population included all participants who were randomized and received study drug.|||score on a scale per 28-day period||Standard Deviation|Mean
2643445|NCT01728454|Secondary|Change From Baseline in Participant-Reported Pain Using Visual Analog Scale (VAS) Pain Score|A 100‐millimeter (mm) VAS was used to grade the severity of dysmenorrhea, and non-menstrual pelvic pain. The lowest value indicated the absence of pain and the highest value indicated pain as bad as it could be; a score of 1-50 was considered mild pain, 51-80 moderate pain and 81-100 severe pain. A negative change from Baseline indicates improvement. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain.|Baseline (Day 1) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)|ITT population included all participants who were randomized and received study drug.|||score on a scale||Standard Deviation|Mean
2643446|NCT01728454|Secondary|Change From Baseline in BBSS Physician-Reported Scores|BBSS Physician-Reported Scores included two scores: Pelvic Tenderness Score (PTS) and Induration Score (IS). PTS was graded on a scale from 0 to 3 where, 0= None; 1= Mild (minimal tenderness on palpation); 2= Moderate (extensive tenderness on palpation); 3= Severe (unable to palpate because of tenderness). IS was graded on a scale from 0 to 3 where, 0= None; 1= Mild (uterus freely mobile, induration on the cul-de-sac); 2= Moderate (thickened and indurated adnexa and cul-de-sac, restricted uterine mobility); 3= Severe (nodular adnexa and cul-de-sac, uterus frequently frozen), with higher scores indicating more severe symptoms. A negative change from Baseline indicates improvement. Data from On-drug cycle and Off-drug interval (ODI) were reported.|Baseline (Day 1) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)|ITT population included all participants who were randomized and received study drug. Last observation carried forward (LOCF) approach was used to impute missing data in this outcome measure.|||score on a scale||Standard Deviation|Mean
2643466|NCT01728337|Primary|Percentage of Responders After 5 Months After the Procedure|"Percentage (%) of responders, after 5 months of injection, to the effects of two botulinum toxin type A (BT-A), Dysport® and Xeomin®. Responders were defined as individuals who presented at least 1 score less in the Wrinkles Scale Score (WSS) at maximum contraction compared to the WSS score at baseline.~WSS is a validated 4-point scale, at rest and at maximum voluntary contraction of the frontalis muscle, in which 0 means no wrinkles up to 3 which means sever wrinkles."|5 months after intervention|80 sujbects were included in this study, each patient have received both products in their faces. The randomization was performed to define the side for each product.|||percentage of participants|||Number
2643447|NCT01728454|Secondary|Percentage Change From Baseline in Total Analgesics Usage|An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. The total analgesics is comprised of prescription and non-prescription analgesics. Participants were provided with a daily diary to record the number of pills of OTC and prescription analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28-day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change indicates improvement.|Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)|ITT population included all participants who were randomized and received study drug.|||percent change||Standard Deviation|Mean
2643448|NCT01728454|Secondary|Change From Baseline in Total Analgesics Usage|An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. The total analgesics is comprised of prescription and non-prescription analgesics. Participants were provided with a daily diary to record the number of pills of OTC and prescription analgesics taken for endometriosis-related pain symptoms each day. The daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.|Baseline (28-day Baseline Menstrual Cycle) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)|ITT Population consisted of all participants who were randomized and received study drug.|||pills per 28-day period||Standard Deviation|Mean
2643449|NCT01728454|Secondary|Percentage Change From Baseline in Non-Prescription Analgesics Usage|An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Nonprescription analgesics are OTC analgesics. Participants were provided with a daily diary to record the number of pills of over the counter drugs taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28 day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change indicates improvement.|Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)|ITT population included all participants who were randomized and received study drug.|||percent change||Standard Deviation|Mean
2643450|NCT01728454|Secondary|Change From Baseline in Non-Prescription Analgesics Usage|An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Nonprescription analgesics are over-the-counter (OTC) analgesics. Participants were provided with a daily diary to record the number of pills of OTC drugs taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.|Baseline (28-day Baseline Menstrual Cycle) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)|ITT population included all participants who were randomized and received study drug.|||pills per 28-day period||Standard Deviation|Mean
2643451|NCT01728454|Secondary|Percentage Change From Baseline in Prescription Analgesics Usage|An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Prescription analgesics are analgesics prescribed by the physician. Participants were provided with a daily diary to record the number of pills of non-narcotic prescription and narcotic analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28.The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28 day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change from Baseline indicates improvement.|Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)|ITT population included all participants who were randomized and received study drug.|||percent change||Standard Deviation|Mean
2643452|NCT01728454|Secondary|Change From Baseline in Prescription Analgesics Usage|An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Prescription analgesics are analgesics prescribed by the physician. Participants were provided with a daily diary to record the number of pills of non-narcotic prescription and narcotic analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.|Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)|ITT population included all participants who were randomized and received study drug.|||pills per 28-day period||Standard Deviation|Mean
2643453|NCT01728454|Primary|Change From Baseline in Individual BBSS Score for Non-Menstrual Pelvic Pain|The BBSS scale defined non-menstrual pelvic pain according to various degrees of discomfort and use of analgesics. The non-menstrual pelvic pain was graded on a scale from 0 to 3 where, 0= None (absence of pain); 1= Mild (occasional pelvic discomfort); 2= Moderate (noticeable discomfort for most of the cycle); 3= Severe (pain persisting during the cycle or requiring strong analgesics), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.|Baseline (28-day Baseline Menstrual Cycle) to the last day dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and to the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)|ITT population included all participants who were randomized and received study drug.|||score on a scale per 28-day period||Standard Deviation|Mean
2643454|NCT01728454|Primary|Change From Baseline in Individual BBSS Score for Dyspareunia|The BBSS scale defined deep dyspareunia according to the limitation of sexual activity. The dyspareunia was graded on a scale from 0 to 3 where, 0= None (no discomfort); 1= Mild (tolerated discomfort); 2= Moderate (intercourse painful to the point of interruption); 3= Severe (intercourse avoided because of pain), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement..|Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)|ITT population included all participants who were randomized and received study drug.|||score on a scale per 28-day period||Standard Deviation|Mean
2643455|NCT01728454|Primary|Change From Baseline in Individual Biberoglu Behrman Symptom Severity Scale (BBSS) Score for Dysmenorrhea|The BBSS scale defined dysmenorrhea according to the loss of work efficiency and need for bed rest. The dysmenorrhea was graded on a scale from 0 to 3 where, 0 = None; 1 = Mild (some loss in work efficiency); 2 = Moderate (in bed part of the day, occasional loss of work efficiency); 3 = Severe (in bed one or more days, incapacitation), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.|Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)|Intent-to-Treat (ITT) population included all participants who were randomized and received study drug.|||score on a scale per 28-day period||Standard Deviation|Mean
2643456|NCT01728376|Secondary|Maximum Plasma Concentration (Cmax) of Daptomycin|Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Peak concentrations were collected up to 15 minutes following the end of infusion. Concentrations below the limit of quantification were excluded.|Days 3, 4, 5 or 6 of treatment at end of infusion|Participants treated with daptomycin with at least one peak sample. Participants in the comparator treatment groups were not analyzed as they were not treated with daptomycin.|||µg/mL||Standard Deviation|Mean
2643457|NCT01728376|Secondary|Trough Plasma Concentration of Daptomycin|Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Trough concentrations were collected 22 to 26 hours following the end of the previous day's end of infusion and before the next infusion. Concentrations below the limit of quantification were excluded.|Days 3, 4, 5 or 6 of treatment at pre-dose|Participants treated with daptomycin with at least one trough sample. Participants in the comparator treatment groups were not analyzed as they were not treated with daptomycin.|||µg/mL||Standard Deviation|Mean
2643458|NCT01728376|Secondary|Percentage of Participants With Overall Success at TOC Visit|Overall success is based on microbiologic responses after initiating study drug and clinical response at TOC/Safety Visit. Overall outcome is a success if both clinical and microbiologic outcomes are successes. An assessment of cure or improved is considered clinical success. Microbiological Success: a participant for whom all baseline infecting pathogens were eradicated (presumed or documented) within 7 days from the start of study drug for uncomplicated bacteremia with no source of infection present, and 10 days for complicated bacteremia or when the source of infection has not been removed.|7-14 days after the last dose of study medication (up to 56 days)|All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.|||Percentage of participants|||Number
2643459|NCT01728376|Secondary|Percentage of Participants With Clinical Success at TOC/Safety Visit|Clinical success was determined by assessing resolution/improvement of signs and symptoms. An assessment of cure or improved is considered clinical success. Cure: resolution of clinically significant signs and symptoms associated with admission infection; no further antibiotic therapy is required for the primary infection under study. Improvement: partial resolution of clinical signs/symptoms of infection such that no further antibiotic therapy is required for the primary infection under study.|7-14 days after the last dose of study medication (up to 56 days)|All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline.|||Percentage of participants|||Number
2643460|NCT01728376|Primary|Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC)|Focused neurological examinations were done at the TOC/Safety Visit. These examinations include assessments of sensation, pupillary reflex and tracking, peripheral reflexes (biceps, patellar tendon, ankle jerk and plantar response), muscle tone and strength (upper and lower limbs), coordination (finger to nose) and tremor of the hands/fingers.|TOC Safety Visit (up to 56 days)|Participants who received any dose of IV study medication.|||Participants|||Number
2643461|NCT01728376|Primary|Percentage of Participants With Sustained CPK Elevations|Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with sustained CPK elevations, defined as two consecutive post-baseline values above the upper limit of normal (ULN)|Baseline up to end of therapy visit (up to 44 days)|Participants who received any dose of IV study medication|||Percentage of Participants|||Number
2643462|NCT01728376|Primary|Percentage of Participants With Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal|Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with maximum post-baseline CPK elevations above the upper limit of 500 Units Per Liter (U/L) .|Baseline up to end of therapy visit (up to 49 days)|Participants who received any dose of IV study medication|||Percentage of Participants|||Number
2643463|NCT01728376|Primary|Number of Participants With One or More Serious Adverse Events (SAEs)|An SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death, life threatening experience, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is considered to be an important medical event.|Administration of first dose through the last follow-up visit (up to 77 days)|Participants who received any dose of IV study medication|||Participants|||Number
2643471|NCT01728324|Primary|SVR12 Rates With Historical Control|"Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level <25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint.~The number of participants analyzed are actually adjusted number of participant analyzed."|12 Week (post-treatment)|Modified full analysis set (mFAS): included patients in the full analysis set (FAS) who received at least one dose of active treatment;|||percentage of participants|||Number
2643472|NCT01728246|Primary|Time to Discontinuation Because of Rescue Medication|Rescue medications are medicines that may be administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation.|Baseline up to Week 4|Time to discontinuation because of rescue medication was not analyzed, because dates when the rescue medication was given were not properly filled out in the forms, hence the exact time to discontinuation because of rescue medication could not be determined or analyzed.||||||
2643473|NCT01728246|Primary|Percentage of Participants Who Discontinued Because of Rescue Medication|Rescue medications are medicines that may be administered to the participants when the efficacy of the study drug is not satisfactory, or the effect of the study drug is too great and is likely to cause a hazard to the participant, or to manage an emergency situation.|Baseline up to Week 4|ITT population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment.|||percentage of participants|||Number
2643474|NCT01728246|Primary|Change From Baseline in ODI Score at Week 4|The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes. The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). A higher score represents greater disability.|Baseline and Week 4 (LOCF)|ITT population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment. LOCF method was used.|||units on a scale||Standard Deviation|Mean
2643475|NCT01728246|Primary|Change From Baseline in Oswestry Disability Index (ODI) Score at Week 2|The ODI is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes. The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0=good to 5=worse). A higher score represents greater disability.|Baseline and Week 2|Data was not analyzed at Week 2 as time frame was too short to assess Quality of Life (QOL) by ODI score.||||||
2643476|NCT01728246|Primary|Change From Baseline in VAS-pain Score at Week 4|VAS is a 100 mm scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change=scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Week 4 Last Observation Carried Forward (LOCF)|ITT population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment. LOCF method was used.|||mm||Standard Deviation|Mean
2643477|NCT01728246|Primary|Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) Score at Week 2|VAS is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change=scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline and Week 2|Intent-to-treat (ITT) population included all the participants who received at least 1 dose of study medication and had at least 1 post-baseline efficacy assessment.|||mm||Standard Deviation|Mean
2643478|NCT01728116|Secondary|Percentage of Subjects Who Achieve % Total Body Weight Loss Greater Than or Equal to 5% at 12 Months||Baseline and 12 Months|mITT population without imputation|||percentage of participants|||Number
2643479|NCT01728116|Secondary|Diastolic BP Change From Baseline||Baseline and 12 Months|mITT population without imputation|||mmHg||Standard Deviation|Mean
2643480|NCT01728116|Secondary|Systolic BP Change From Baseline||Baseline and 12 Months|mITT population without imputation|||mmHg||Standard Deviation|Mean
2643481|NCT01728116|Secondary|Fasting Glucose Change From Baseline||Baseline and 12 Months|mITT population without imputation|||mg/dL||Standard Deviation|Mean
2643482|NCT01728116|Secondary|Triglycerides Change From Baseline||Baseline and 12 Months|mITT population without imputation|||mg/dL||Standard Deviation|Mean
2643483|NCT01728116|Secondary|LDL Change From Baseline||Baseline and 12 Months|mITT without imputation|||mg/dL||Standard Deviation|Mean
2643484|NCT01728116|Secondary|Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months||Baseline and 12 Months|mITT population without imputation|||percentage of participants|||Number
2643485|NCT01728116|Secondary|Assessment of Total Cholesterol Change at 12 Months Compared to Baseline||Baseline and 12 Months|mITT population without imputation|||mg/dL||Standard Deviation|Mean
2643486|NCT01728116|Primary|Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE|Of the 161 subjects for whom data were available at 12 Months, 19 (11.8%) subjects experienced device-related SAEs that required an early device removal.|Baseline and 12 Months|mITT without Imputation|||percentage of participants||95% Confidence Interval|Number
2643487|NCT01728116|Primary|Primary Efficacy Endpoint: Improvement in HbA1c|Mean Change in HbA1c from Baseline to 12 Months in the mITT population with Bayesian Imputation|Baseline and12 months|All randomized subjects who at their baseline endoscopy are judged to be potential recipients of the device (meaning no abnormal pathologies and/or conditions are present). Any subject who has a device enter their body, regardless of eligibility or randomization assignment, is also included in the treatment arm of the mITT population.|||Percentage of HbA1c||Standard Deviation|Mean
2645029|NCT01714310|Secondary|Weight|Weight in kg.|Baseline through week 12.|Some participants discontinued as trial progressed.|||kg.||Standard Error|Least Squares Mean
2643488|NCT01728077|Secondary|50 % Responder Rate in Partial-Onset-Seizure (POS) Type I Frequency From Baseline of the Previous Study to the Evaluation Period for Subjects With Focal-onset Epilepsy Entering N01372 From a Study Where Baseline Seizure Data Was Collected|The POS frequency is standardized to a 28-day duration. A responder is defined as a subject with a >=50% reduction in seizure frequency from the Baseline Period of the previous study. Results are presented as the percentage of subjects with 50 % responder rate in POS Type I frequency.|From Baseline of the previous study to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 49 months)|The analysis was performed on the Efficacy Analysis Set (EAS), which consisted of subjects who took at least one dose of study drug and had at least one seizure daily record card (DRC) day during the Evaluation Period.|||percentage of subjects|||Number
2643489|NCT01728077|Secondary|Percentage of Change in Partial-Onset-Seizure (POS) Type I Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period for Subjects With Focal-onset Epilepsy Entering N01372 From a Study Where Baseline Seizure Data Was Collected|The POS frequency is standardized to a 28-day duration. Results are presented as the median percentage of reduction per 28 days. Negative values indicate improvement from Baseline.|From Baseline of the previous study to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 49 months)|The analysis was performed on the Efficacy Analysis Set (EAS), which consisted of subjects who took at least one dose of study drug and had at least one seizure daily record card (DRC) day during the Evaluation Period.|||percentage of change||Full Range|Median
2643490|NCT01728077|Secondary|Frequency of Partial-Onset Seizure (POS) Type I Per 28 Days During the Evaluation Period for Subjects With Focal-onset Epilepsy|The POS frequency is standardized to a 28-day duration. Results are presented as the median number of seizures per 28 days.|From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)|The analysis was performed on the Efficacy Analysis Set (EAS), which consisted of subjects who took at least one dose of study drug and had at least one seizure daily record card (DRC) day during the Evaluation Period.|||Seizures per 28 days||Full Range|Median
2643491|NCT01728077|Primary|Occurrence of a Serious Adverse Event (SAE) During the Evaluation Period|SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/birth defects. Results are presented as the percentage of subjects with at least one SAE during this study.|From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)|The analysis was performed on the Safety Set (SS), which consisted of all subjects who took at least 1 dose of study drug.|||percentage of subjects|||Number
2643492|NCT01728077|Primary|Percentage of Subjects Withdrawn Due to an Adverse Event (AE) During the Evaluation Period|An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. Results are presented as the percentage of subjects withdrawn due to an AE.|From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)||||percentage of subjects|||Number
2643493|NCT01728077|Primary|Incidence of Treatment Emergent Adverse Events (TEAEs) During Evaluation Period|TEAEs were defined as AEs that had onset on or after the day of first study medication dose. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study.|From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)||||percentage of subjects|||Number
2643494|NCT01727895|Secondary|the Composition of Faecal Microbiota||Days 0, 6, 21|||||||
2643495|NCT01727895|Secondary|• the Leukocyte Capacity to Phagocytose and Kill the Fungal Pathogen Candida Albicans (Antifungal Activity).||Days 0, 6, 21|||||||
2643496|NCT01727895|Secondary|• Changes in Phenotype and Gene Expression Caused by Mechanisms Other Than Changes in the Underlying DNA Sequence (Epigenetic Modifications)||Days 0, 6, 21|||||||
2643497|NCT01727895|Secondary|• Transcriptional Pathways (by Use of Microarrays) With Focus on Inflammatory Pathways.||Days 0, 6, 21|||||||
2643498|NCT01727895|Secondary|• the Absorbance of Orally Administered Beta-glucan Into the Blood Compartment, Measured by ELISA||Days 0, 6, 21|||||||
2643499|NCT01727895|Secondary|• Production of Other Cytokines (TNF-α, Interleukin (IL)-6, IL-10, IL-1β, IL-17, IL-22, Interferon (IFN)-γ) by Leukocytes ex Vivo Stimulated With Various Stimuli (Including LPS, Pam3Cys, Mycobacterium Tuberculosis, Poly(I:C), Candida, Staph Aureus)||days 0, 6, 21|||||||
2643500|NCT01727895|Primary|Tumor Necrosis Factor (TNF)-α Secretion by ex Vivo Lipopolysaccharide (LPS)-Stimulated Peripheral Blood Mononuclear Cells (PBMCs)|The primary objective of the study is to evaluate the systemic effects of orally administered Beta-glucan on innate immune responses of leukocytes. The effects of Beta-glucan will be determined by measuring the ex vivo responsiveness of leukocytes to various inflammatory stimuli as a surrogate marker of the antimicrobial response|up to 21 days||||pg/ml||Inter-Quartile Range|Median
2643501|NCT01727791|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|The following parameters were analyzed for examination of vital signs: electrocardiogram (ECG), systolic and diastolic blood pressure, temperature, pulse rate, respiratory rate, radial pulse and body temperature.|Baseline up to 28 days after last dose of study drug|The safety analysis population included participants who received at least 1 dose of study medication.|||participants|||Number
2643502|NCT01727791|Other Pre-specified|Number of Participants With Laboratory Abnormalities|The following parameters were analyzed for laboratory abnormalities: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelets, white blood cell count, lymphocytes, total neutrophils, basophils, eosinophils, monocytes); liver function (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose); urinalysis (urine pH, glucose, ketones, protein, urine blood/hemoglobin, nitrite).|Baseline up to 28 days after last dose of study drug|The safety analysis population included participants who received at least 1 dose of study medication.|||participants|||Number
2643503|NCT01727791|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline up to 28 days after last dose of study drug|The safety analysis population included participants who received at least 1 dose of study medication.|||participants|||Number
2643504|NCT01727791|Primary|Infant Dose Expressed as Percentage of Body Weight Normalized Maternal Dose (BWNIDPCM)|Infant dose expressed as percentage of body weight normalized maternal dose (BWNIDPCM) was the relative infant dose (relative to maternal dose) calculated by the formula: 100 * BWNID (Body Weight Normalized Infant Dose) / Body Weight Normalized Maternal Dose (BWNMD), where tau was the dosing interval of 12 hours.|Pre-dose to 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||percentage of dose||Full Range|Mean
2643505|NCT01727791|Primary|Body Weight Normalized Maternal Dose (BWNMD)|Body weight normalized maternal dose (BWNMD) was calculated as the maternal dose in microgram per day (mcg/day) divided by maternal weight in kilogram (kg) at screening.|Pre-dose to 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg/kg/day||Full Range|Mean
2643506|NCT01727791|Primary|Body Weight Normalized Infant Dose (BWNID)|Body weight normalized infant dose (BWNID) of pregabalin was the dose that an infant received from breast-feeding and was calculated from the milk to plasma AUCtau ratio multiplied by the average maternal plasma pregabalin concentration (Cav) multiplied by the standardized milk consumption for an infant (150 milliliter/kilogram/day [mL/kg/day]), where tau was the dosing interval of 12 hours.|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg/kg/day||Full Range|Mean
2643507|NCT01727791|Primary|Milk to Plasma Ratio for Maximum Observed Concentration (MPCmax)|Milk to plasma ratio for maximum observed concentration (MPCmax) was calculated as the ratio of Cmax (breast milk) to Cmax (plasma).|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||ratio||Full Range|Mean
2643508|NCT01727791|Primary|Milk to Plasma Ratio for AUCtau (MPAUCtau)|MPAUCtau was the ratio of AUCtau (breast milk) to AUCtau (plasma), where tau was the dosing interval of 12 hours.|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||ratio||Full Range|Mean
2643509|NCT01727791|Primary|Daily Amount of Pregabalin Excreted in Breast Milk (Ae24bm)|Ae24bm was the daily amount of pregabalin excreted in breast milk. It was calculated by the formula: 2 * Aetaubm (sum of [breast milk concentration * sample volume] for each collection interval from 0 to 12 hours post-dose), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg||Full Range|Mean
2643510|NCT01727791|Primary|Renal Clearance (CLr)|Renal clearance (CLr) was the volume of plasma from which the drug was completely removed by the kidney in a given amount of time. It was calculated by dividing Aetauurine (sum of [urine concentration * sample volume] for each collection interval from 0 to 12 hours post-dose) with the plasma AUCtau, where tau was the dosing interval of 12 hours.|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Urine: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8 and 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2643511|NCT01727791|Primary|Percent of Dose Recovered in Urine During the Dosing Interval Tau (Aetauurine Percent)|Percent of dose recovered in urine during the dosing interval tau (Aetauurine percent) was calculated as 100* (Aetau [sum of {urine concentration * sample volume} for each collection interval from 0 to 12 hours post-dose] divided by the dose), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||percentage of dose||Geometric Coefficient of Variation|Geometric Mean
2643512|NCT01727791|Primary|Amount Recovered in Urine During the Dosing Interval Tau (Aetauurine)|Aetauurine was the amount excreted in urine over the dosing interval tau (12 hours). It was calculated as the sum of (urine concentration * sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Here, sample volume was based on the ratio of volume weight and density.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mg||Geometric Coefficient of Variation|Geometric Mean
2643513|NCT01727791|Primary|Breast Milk Clearance (CLbm)|Breast milk clearance (CLbm) was calculated by dividing Aetaubm (sum of [breast milk concentration * sample volume] for each collection interval from 0 to 12 hours post-dose) by plasma AUCtau, where tau was the dosing interval of 12 hours.|Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2643514|NCT01727791|Primary|Percentage of Dose Excreted in Breast Milk During the Dosing Interval Tau (Aetaubm Percent)|Percentage of dose excreted in breast milk during the dosing interval tau (Aetaubm percent) was calculated by using the formula: 100*(Aetaubm [sum of {breast milk concentration * sample volume} for each collection interval from 0 to 12 hours post-dose] divided by dose), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||percentage of dose||Geometric Coefficient of Variation|Geometric Mean
2643515|NCT01727791|Primary|Amount Excreted in Breast Milk Over the Dosing Interval Tau (Aetaubm)|Aetaubm was the amount excreted in breast milk over the dosing interval tau (12 hours). It was calculated as the sum of (breast milk concentration * sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Sample volume was based on ratio of volume weight and density.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg||Geometric Coefficient of Variation|Geometric Mean
2643516|NCT01727791|Primary|Average Breast Milk Concentration During the Dosing Interval (Cav)|Average breast milk concentration during the dosing interval (Cav) was calculated by dividing AUCtau (breast milk) with tau, where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg/mL||Full Range|Mean
2643517|NCT01727791|Primary|Terminal Half-Life for Breast Milk (t1/2 [Breast Milk])|The terminal half-life for breast milk (t1/2 [breast milk]) was the time measured for breast milk concentration to decrease by one-half. For the first 5 participants enrolled under protocol amendment dated: 18 Sep 2012, breast milk was collected up to 24 hours after Day 3 dosing over the following time intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 hours. Terminal half-life was determined over those points characterizing the elimination phase. For the remaining 5 participants, there were 3 additional collection intervals (24 to 32, 32 to 40, 40 to 48 hours) for characterizing the terminal elimination phase. The t1/2 (breast milk) is based on the terminal elimination phase time points from this timeframe.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||hr||Standard Deviation|Mean
2643518|NCT01727791|Primary|Time to Reach Maximum Observed Breast Milk Concentration (Tmax [Breast Milk])|Tmax (breast milk) was time of the maximum observed breast milk concentration Day 3 post-dose.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||hr||Full Range|Median
2643519|NCT01727791|Primary|Maximum Observed Concentration in Breast Milk (Cmax [Breast Milk])|Cmax (breast milk) was the maximum observed concentration in breast milk post Day 3 dose.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2643520|NCT01727791|Primary|Area Under the Curve From Time Zero to End of Dosing Interval for Breast Milk (AUCtau [Breast Milk])|AUCtau (breast milk) was the area under the curve for breast milk, from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2643521|NCT01727791|Primary|Apparent Oral Clearance (CL/F)|Apparent oral clearance (CL/F) was calculated by dividing dose by the AUCtau, where tau was the dosing interval of 12 hours. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mL/minute||Geometric Coefficient of Variation|Geometric Mean
2643522|NCT01727791|Primary|Minimum Observed Plasma Trough Concentration (Cmin)|Cmin was the minimum observed plasma concentration of a drug after post Day 3 dose.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2643523|NCT01727791|Primary|Average Plasma Concentration During the Dosing Interval (Cav)|Average plasma concentration during the dosing interval (Cav) was calculated by dividing AUCtau (plasma) with tau, where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2643524|NCT01727791|Primary|Plasma Half-Life (t1/2)|Plasma decay half-life (t1/2) was the time for the plasma concentration to decrease by one-half. The t1/2 is based on the terminal elimination phase time points from this timeframe.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||hr||Standard Deviation|Mean
2643525|NCT01727791|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)|Tmax was the time to peak concentration in plasma post Day 3 dose.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||hr||Full Range|Median
2645030|NCT01714310|Secondary|Height|A dimensional measure assessed in cms.|Baseline through week 12.|Participants discontinued as trial progressed.|||cm.||Standard Error|Least Squares Mean
2643526|NCT01727791|Primary|Maximum Observed Plasma Concentration (Cmax)|Cmax was the peak concentration in plasma post Day 3 dose.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3|The PK parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2643527|NCT01727791|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|Area under the plasma concentration-time profile from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours.|Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3|The pharmacokinetic (PK) parameter analysis population included participants who received study medication and who had at least 1 of the PK parameters of primary interest.|||microgram*hour/milliliter (mcg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2643528|NCT01727765|Primary|Maximal Inspiratory Mouth Pressure (MIP)|MIP is a surrogate measure of inspiratory muscle strength and was measured pre and post 6 weeks of either experimental or sham inspiratory muscle trianing (IMT).|pre (after the 4 week run-in) and post 6 weeks of IMT|As this was a feasibility study, statistical analysis was not required|||kPa||Standard Deviation|Mean
2643529|NCT01727726|Secondary|Sheehan Disability Scale (SDS) Individual Item Scores.|To evaluate mean change in SDS score from randomization (End of Phase A) to end of Phase B. The Sheehan Disability Scale (a self rated questionnaire) was used for measurement of functional disability and impairment due to psychiatric symptoms. The SDS is a visual analogue scale that uses spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the three domains (work/school work, social life/leisure activities and family life/home responsibilities). All domains were rated on a score scale ranged from 0 (no impairment) to 10 (most severe). Score of 5 and above indicated significant functional impairment. A total score was addition of the 3 individual scores and the total score ranged from 0 (no impairment) to 30 (most severe).|Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16).|All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B.|||units on a scale||Standard Error|Least Squares Mean
2643530|NCT01727726|Secondary|Number of Participants With Adverse Events|To evaluate the safety and tolerability of brexpiprazole (flexible dose) as adjunctive therapy to ADT in the proposed subject population with MDD as AE variables.|From screening (Day -28 to Day-1) upto post treatment follow-up.|Randomized subjects in Phase B who received at least one dose of double-blind trial medication as indicated on the dosing record.|||Participants|||Count of Participants
2643531|NCT01727726|Secondary|CGI-I Response Rate|CGI-I Response rate, where response was defined as a CGI-I score of 1 or 2 (very much improved or much improved), during double-blind randomized Phase B treatment.|Phase B week 6 (14/16 weeks after randomization).|All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B.|||Participants|||Count of Participants
2643532|NCT01727726|Secondary|Number of Participants With MADRS|MADRS Remission Rate, where remission was defined as MADRS Total Score ≤ 10 and 50% reduction in MADRS Total Score, for every trial week visit during double-blind randomized Phase B treatment.|Phase B week 6 (14/16 weeks after randomization).|Number of subjects in the Safety Sample who had an end of Phase A (ie, Week 8 or 10) value and at least one post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Participants|||Count of Participants
2643533|NCT01727726|Secondary|MADRS Response at Week 6|MADRS Response Rate, where response was defined as 50% reduction in MADRS Total Score, during double-blind randomized Phase B treatment.|Phase B week 6 (14/16 weeks after randomization).|All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B.|||Participants|||Count of Participants
2643534|NCT01727726|Secondary|Clinical Global Impression Score|Mean change from end of Phase A in Clinical Global Impression - Severity of Illness scale (CGI-S) score and Improvement scale (CGI-I) during double-blind randomized Phase B treatment. CGI-S score assessed how mentally ill the patient was at that time. CGI-S score is calculated from 0 to 7 (0 indicates not assessed 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and7 indicated among the most extremely ill patient). CGI-I score is compared to his/her condition at baseline, how much has the patient changed. CGI-I score is calculated from 0 to 7 (0 indicates not assessed and 7 indicates very much worse).|From randomization to Phase B week 6 (14/16 weeks after randomization).|All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for CGI-S score and CGI-I score in Phase B.|||Mean score||Standard Deviation|Mean
2643535|NCT01727726|Secondary|Change From End of Phase A in MADRS Total Score for Trial Week 2 and Week 4.|Change from end of Phase A in MADRS Total Score. The MADRS was used to assess the subject's level of depression by utilizing the structured interview guide for the MADRS (SIGMA). The MADRS depression rating scale was used to assess the subject's level of depression by utilizing the structured interview guide for the MADRS (SIGMA). The MADRS consisted of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated 0 to 6. The overall score ranged from 0 (symptoms absent) to 60 (severe depression). Lower score indicated decreased severity of depression.|Change from baseline to week 2 and week 4 in Phase B (week 10/12 and week 12/14)|All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B.|||units on a scale||Standard Error|Least Squares Mean
2643544|NCT01727713|Primary|Change From Baseline in Pediatric Anxiety Rating Scale (PARS).|The PARS is used to rate the severity of anxiety in children and adolescents, aged 6 to 17 years. The PARS has 2 sections: the symptom checklist and the severity items. The symptom checklist is used to determine the child's repertoire of symptoms during the past week. The 7-item severity list is used to determine severity of symptoms and the PARS total score. The time frame for the PARS is the past week. Only those symptoms endorsed for the past week are included in the symptom checklist and rated on the severity items. The PARS total severity score was the sum of items 2, 3, 5, 6, and 7. The total severity score ranged from 0 (no anxiety) to 25 (worst anxiety).|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.|||Units on a scale||Standard Deviation|Mean
2643536|NCT01727726|Secondary|Sheehan Disability Scale (SDS)|To evaluate mean change in SDS score from randomization (End of Phase A) to end of Phase B. The Sheehan Disability Scale is a measurement of functional disability and impairment due to psychiatric symptoms. The SDS is a visual analogue scale that uses spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the three domains ( work/social life/family life/home responsibilities). The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. Scores of 5 and above are associated with significant functional impairment. Additionally, SDS included 2 questions related to productivity losses due to the psychiatric symptoms and impairment.|Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16).|All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for SDS Score in Phase B.|||units on a scale||Standard Error|Least Squares Mean
2643537|NCT01727726|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|To determine the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy by assessment of MADRS total score. The MADRS depression rating scale was used to assess the subject's level of depression by utilizing the structured interview guide for the MADRS (SIGMA). The MADRS consisted of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated 0 to 6. The overall score ranged from 0 (symptoms absent) to 60 (severe depression). Lower score indicated decreased severity of depression.|Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16).|All subjects in the Safety Sample who have an end of Phase A (ie, Week 8 or 10) value and at least one post-randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
2643538|NCT01727713|Secondary|Percentage of Participants With Treatment Discontinuation (Treatment Discontinuation Rate).|The treatment discontinuation rate was calculated as the number of discontinued participants (ie, those withdrawn from the study without completing the Week 52 visit) divided by the number of all enrolled participants.|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.|||Percentage of discontinued participants|||Number
2643539|NCT01727713|Secondary|Percentage of Participants With Response (Response Rate).|Clinical response was defined as > 25% improvement from Baseline to endpoint in YGTSS TTS or a CGI-TS change score of 1 (very much improved) or 2 (much improved) at endpoint.|Weeks 4, 8, 12, 20, 28, 36, 44 and 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.|||Percentage of participants with response|||Number
2643540|NCT01727713|Secondary|Mean Change From Baseline to Endpoint in Total YGTSS Score.|The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) for motor and vocal tics, and an impairment ranking. The YGTSS TTS is the summation of the severity scores of motor and vocal tics (range of 0 [no impairment] to 50 [maximum impairment]). The total YGTSS score is the summation of the severity scores of motor and vocal tics and the ranking of impairment (total range of 0 [no impairment] to 100 [maximum impairment]).|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
2643541|NCT01727713|Secondary|Change From Baseline to Endpoint in CGI-TS Severity of Illness Score.|The final CGI-TS score was compared to the participant's baseline condition at the time of entry into the open-label study, rather than the CGI-TS baseline condition at the time participants enrolled into the preceding study. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
2643542|NCT01727713|Secondary|Mean Clinical Global Impressions for Tourette's Syndrome (CGI-TS) Change Score at Endpoint.|"The CGI is a 7-point Likert scale used in a multitude of clinical trials as a clinical global measure to assess the severity and change in disease symptomatology (ie, tics). The CGI was included as a secondary scale to provide a more complete assessment of clinical efficacy. To assess CGI-TS severity, the rater or investigator will answer the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? However, the evaluation of illness will be limited to manifestations of Tourette's Disorder only. Response choices include: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients."|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
2643543|NCT01727713|Secondary|Change From Baseline to Endpoint on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS).|The YGTSS is a semi-structured clinical interview which consists of a tic inventory, with 5 separate ratings to assess the number, intensity, frequency, complexity and interference of tics, plus an overall impairment/disability score. Ratings are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. Summation of these 10 scores (ie, 0-50) provides a TTS that was the secondary outcome measure in this trial. The YGTSS ranking of impairment, with a maximum of 50 points, is based on the impact of the tic disorder on areas of self-esteem, family life, social acceptance, and school scores. The total severity score ranged from 0 (no impairment) to 50 (worst impairment).|Baseline to Week 52|All participants who receive at least 1 dose of open-label study drug in this trial, and have baseline and at least 1 post-baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
2643553|NCT01727713|Primary|Mean Change From Baseline in Body Mass Index (BMI).|BMI was calculated at the Baseline visit (using the Baseline height from study 31-12-293) and at Weeks 28 and 52/ET where height measured at baseline in the current trial was used to calculate BMI.|Baseline to Weeks 28, 52 and Last visit.|Safety Sample: All participants who received at least 1 dose of open-label study drug and who had a least one post-baseline BMI measurement.|||Kg/M^2||Standard Deviation|Mean
2643545|NCT01727713|Primary|Change From Baseline in Children's Depression Rating Scale - Revised (CDRS-R).|The CDRS-R is a brief rating scale based on a semi-structured interview with the child and an adult informant who knows the child well. Designed for 6- to 12-year-old children, and successfully used with adolescents, it can be administered in 15 to 20 minutes. The interviewer rates 17 symptom areas (including those that serve as Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision criteria for a diagnosis of depression): impaired schoolwork, difficulty having fun, social withdrawal, appetite disturbance, sleep disturbance, excessive fatigue, physical complaints, irritability, excessive guilt, low self-esteem, depressed feelings, morbid ideas, suicidal ideas, excessive weeping, depressed facial affect, listless speech, and hypoactivity. The CDRS-R total score is the sum of scores for the 17 symptom areas and could range from 17 to 113 with higher values indicating worse outcome.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.|||Units on a scale||Standard Deviation|Mean
2643546|NCT01727713|Primary|Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS).|The CY-BOCS is a semi-structured interview used with children and adolescents aged 6 to 17 years to rate the severity and type of symptoms in participants with obsessive compulsive disorder. In general, the items depend on the participant's report; however, the final rating is based on the clinical judgment of the interviewer and should include additional information supplied by others. Nineteen items are rated in the CY-BOCS, but only items 1 through 10 (excluding items lb and 6b) are used to determine the total score. The total CY-BOCS score is the sum of items 1 through 10 (excluding lb and 6b), whereas the obsession and compulsion subtotals are the sums of items 1 through 5 (excluding lb) and 6 through 10 (excluding 6b), respectively. CY-BOCS total score could range from 0 to 40, and the obsession and compulsion subscale total scores could each range from 0 to 20. Higher scores indicate worse outcome.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.|||Units on a scale||Standard Deviation|Mean
2643547|NCT01727713|Primary|Change From Baseline in Average Score of Attention Deficit Disorder/Attention-deficit Hyperactivity Disorder (ADD/ADHD) of Swanson, Nolan, and Pelham-IV Rating Scale (SNAP-IV).|The SNAP-IV Rating Scale is a revision of the SNAP Questionnaire. The SNAP-IV assesses inattention and hyperactivity/impulsivity, as well as oppositional defiant disorder that are often present in children with ADD/ADHD. The SNAP-IV was administered as a semi-structured interview with the participant and caregiver. The SNAP-IV is based on a 0 to 3 rating scale: not at all = 0, just a little = 1, quite a bit = 2, and very much = 3. The ADD/ADHD subscale includes items 1 through 19 (items 1-9 measure inattention, items 11-19 measure hyperactivity/ impulsivity, and item 10 for inattention domain), items 4, 8, 11, 31, and 32 measure inattention/overactivity, and items 21, 23, 29, 34, and 35 measure aggression/defiance. Items 4, 8, 11, 21, 32, 33, 36, 37, 38, and 39 form the Conners Index. Subscale average scores on the SNAP IV were calculated by summing the scores on the items in the subset and dividing by the number of items in the subset.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.|||Units on a scale||Standard Deviation|Mean
2643548|NCT01727713|Primary|Change From Baseline in Suicidal Ideation Intensity Total Score Based on Columbia-Suicide Severity Rating Scale (C-SSRS).|"The C-SSRS consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post baseline/since last visit evaluation that focuses on suicidality since the last trial visit. The C-SSRS data at Baseline and post baseline were summarized for incidence of reporting: Suicidality, Suicidal behavior (and its 4 types), Suicidal ideation (and its 5 types). The intensity score of each item ranges from 1 (least severe) to 5 (most severe), which leads to the range of the total score from 0 to 25."|Baseline, Weeks 1, 2, 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.|||Units on a scale||Standard Deviation|Mean
2643549|NCT01727713|Primary|Change From Baseline in Barnes Akathisia Rating Scale (BARS) Total Score.|The BARS Global Score is derived from the global clinical evaluation of akathisia on a 6-point scale, with 0 representing absence of symptoms and a score of 5 representing severe akathisia.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.|||Units on a scale||Standard Deviation|Mean
2643550|NCT01727713|Primary|Change From Baseline in Simpson-Angus Scale (SAS) Total Score.|The SAS consists of a list of 10 symptoms of Parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item was rated on a 5-point scale, with a score of 1 representing absence of symptoms, and a score of 5 representing a severe condition. The SAS total score (range 10 to 50) was the sum of the rating scores for 10 items from the SAS panel.|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.|||Units on a scale||Standard Deviation|Mean
2643551|NCT01727713|Primary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score.|The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest, and the investigator also made global judgments on the participant's dyskinesias (items 8 through 10). Each item was rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness/severe distress). In addition, the AIMS included 2 yes/no questions that addressed the subject's dental status (since an edentulous state can cause lingual dyskinesias). The AIMS movement rating score (range 0 to 28) was the sum of the rating scores for facial and oral moments (ie, items 1 to 4), extremity movements (ie, items 5 and 6), and trunk movements (ie, item 7).|Baseline, Weeks 4, 8, 12, 20, 28, 36, 44, 52, and Last visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.|||Units on a scale||Standard Deviation|Mean
2643552|NCT01727713|Primary|Mean Change From Baseline in Waist Circumference.|Waist circumference was measured at Baseline, Weeks 12, 28, 36, 44, and the Week 52/last visit in centimeters.|Baseline to Weeks 12, 28, 36, 44, and 52/last visit.|Safety Sample: All participants who received at least 1 dose of open-label study drug and who had a least one post-baseline waist circumference measurement.|||Centimeter||Standard Deviation|Mean
2643554|NCT01727713|Primary|Mean Change From Baseline in Body Weight.|Criteria for identifying weight of potential clinical relevance was: ≥ 7% kilogram increase/decrease from Baseline (Final visit of Trial 31-12-293).|Baseline to Weeks 12, 28, 36, 44, 52/Last visit.|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who had at least one post-baseline weight measurement.|||Kilogram||Standard Deviation|Mean
2643555|NCT01727713|Primary|Percentage of Participants With Clinically Significant Abnormal Electrocardiogram (ECG).|Three 12-lead ECGs (scheduled 5 minutes apart) were recorded. Some of the pre-defined criteria for identifying ECG measurements of potential clinical relevance included: Tachycardia/sinus tachycardia: increase of ≥15 bpm from Baseline; increase in QTc of ≥10% from Baseline. The other abnormalities not present at Baseline and were present during the time of measurement were recorded. Percentage of participants noted with abnormal ECG findings are reported below.|Baseline to Week 52|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who who had at least one post-baseline ECG result were included.|||Percentage of participants|||Number
2643556|NCT01727713|Primary|Percentage of Participants With Clinically Significant Abnormal Vital Signs.|Vital sign measurements included systolic and diastolic blood pressure (BP) and heart rate, which were performed at all clinic visits. Criteria for identifying vital signs of potential clinical relevance included: Heart rate: ≥ 15 beats per minute (bpm) increase/decrease from Baseline (final visit of study 31-12-293); Systolic BP: ≥ 20 mmHg increase/decrease from Baseline; Diastolic BP: ≥ 15mmHg increase/decrease from Baseline; Orthostatic hypotension: ≥ 20 mmHg decrease in systolic BP and a ≥ 25 bpm increase in heart rate from supine to sitting/standing. Percentage of participants noted with abnormal vital sign measurements are reported below.|Baseline to Week 52|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who who had at least one post-baseline vital sign result were included.|||Percentage of participants|||Number
2643557|NCT01727713|Primary|Percentage of Participants With Clinically Significant Abnormal Laboratory Test Results.|Laboratory tests including hematology, serum chemistry, and urinalysis were performed for all the participants. The central laboratory was used for all laboratory testing whenever possible. Any value outside the normal range was flagged for the attention of the study physician who was to indicate whether the value was clinically significant based on the pre-defined criteria for identifying laboratory values of potential clinical relevance. Percentage of participants noted with abnormal laboratory values are reported below.|Baseline to Week 52|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial and who had at least one post-baseline laboratory value were included.|||Percentage of participants|||Number
2643558|NCT01727713|Primary|Percentage of Participants With Adverse Events.|An AE is defined as any untoward medical occurrence in a patient or participant enrolled in the clinical trial and which does not necessarily have to have a causal relationship with the study drug. A treatment emergent adverse event (TEAE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to have a causal relationship with the study drug. Serious adverse event (SAE) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires in-patient hospitalization or prolonged hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.|Baseline, throighout the 52-week treatmetn and 30±3 days after last trial visit|Safety Sample: All participants who received at least 1 dose of open-label study drug in this trial.|||Percentage of participants|||Number
2643559|NCT01727700|Secondary|Treatment Discontinuation Rate|Treatment discontinuation rate will be calculated as the number of discontinued participants (ie, those who were withdrawn from the trial without completing the Week 8 visit) over the number of all randomized participants.|Week 8|ITT Population: All participants randomly assigned to the double-blind treatment.|||Percentage of participants|||Number
2643560|NCT01727700|Secondary|Response Rate|Clinical response is defined as > 25% improvement from baseline to Week 8 in YGTSS TTS or a CGI-TS Change score of 1 [very much improved] or 2 [much improved] at Week 8. Response will be considered as missing only if both YGTSS TTS and CGI-TS change score are missing. As long as one of them is non-missing, response outcome will be determined based on the non-missing score.|Week 8|ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.|||Percentage of Responders|||Number
2643561|NCT01727700|Secondary|Mean Change From Baseline to Endpoint (Week 8) in CGI-TS Severity Score|The CGI-TS Severity scale (range 0-7) is a single-item rating score, with higher scores representing greater severity or less improvement. A response of 0 (not assessed) is considered and handled as missing data.|Baseline to Week 8|ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.|||Units on a scale||Standard Error|Least Squares Mean
2643562|NCT01727700|Secondary|Mean Change From Baseline to Endpoint (Week 8) in Total YGTSS Score|The YGTSS consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms (on a scale of 0 to 5 for 5 different dimensions, including number, frequency, intensity, complexity, and interference) of motor and vocal tics, and an impairment ranking. The Total YGTSS score is the summation of the severity scores of motor and vocal tics and also the ranking of impairment (range of 0 to 100). A missing value of a YGTSS item scale could result in a missing Total YGTSS score. A reduction in Total YGTSS score from baseline represents an improvement in symptoms.|Baseline to Week 8|ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.|||Units on a scale||Standard Error|Least Squares Mean
2643603|NCT01727024|Secondary|Number of Participants Correctly Using the Device After One Week of Handling|The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices.|day 7|The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with day 7 values were analyzed.|||Participants|||Number
2645031|NCT01714310|Secondary|Clinical Global Impression - Improvement|Percentage improved by treatment group|Percentage improved at week 4 for Open Lisdexamfetamine group and at week 12 for fluoxetine and placebo groups.|Some participants discontinued as trial progressed.|||Participants|||Count of Participants
2643563|NCT01727700|Secondary|Change in Clinical Global Impressions Scale-Tourette's Syndrome (CGI-TS) Score at Week 8.|"To assess CGI-TS severity, the rater or physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? However, the evaluation of illness was limited to manifestations of TD only. Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The change score was obtained from CGI-TS improvement scale assessment: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse."|Week 8|ITT Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.|||Units on a scale||Standard Error|Least Squares Mean
2643564|NCT01727700|Primary|Change From Baseline to Week 8 in Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS).|The YGTSS is a semi-structured clinical interview designed to measure current (time frame of the past 1 week) tic severity. This scale consists of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings are made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics each, including number, frequency, intensity, complexity, and interference. Summation of these 10 scores (ie, 0-50) provides a TTS that was the primary outcome measure in this trial. The YGTSS ranking of impairment score rated on a 50-point scale anchored from 0 (no impairment) to 50 (severe impairment) to assess impairment experienced in areas of self-esteem, family life, social acceptance, and school scores. This is a fully validated scale in adults and has become a standard instrument for the evaluation of the severity of TD in children.|Baseline to Week 8|Intent-to-Treat (ITT) Population: All participants randomly assigned to the double-blind treatment. At Week 8, data were available for 42 participants in the low dose, 35 in the high dose and 42 in the placebo group.|||Units on a scale||Standard Error|Least Squares Mean
2643565|NCT01727505|Other Pre-specified|Tidal Volume|The mean exhaled tidal volume of mechanical breaths.|24 hours||||ml/Kg||Standard Deviation|Mean
2643566|NCT01727505|Other Pre-specified|Fraction of Inspired Oxygen (FiO2)|"Calculated as the mean value of the recorded fraction of inspired oxygen for each subject during each of the two 24 hour periods.~Reported as median and inter-quartile range of all subjects."|24 hours||||fraction||Inter-Quartile Range|Median
2643567|NCT01727505|Secondary|Duration of Hypoxemia Episodes|Duration of hypoxemia episodes of arterial saturation < 85% for at least 20 seconds. Calculated as the mean episode duration per subject per period. Reported as median and inter-quartile range of all subjects.|24 hours||||seconds||Inter-Quartile Range|Median
2643568|NCT01727505|Secondary|Frequency of Hypoxemia Episodes|Frequency of hypoxemia episodes defined as episodes with arterial saturation < 85% for at least 20 seconds|24 hours||||hypoxemia episodes per hour||Inter-Quartile Range|Median
2643569|NCT01727505|Secondary|Frequency of Severe Hypoxemia Episodes|Frequency of severe hypoxemia episodes defined as periods with arterial oxygen saturation SpO2 < 75% lasting for at least 20 seconds.|24 hours||||severe hypoxemia episodes per hour||Inter-Quartile Range|Median
2643570|NCT01727505|Primary|Percentage of Time Spent With Arterial Oxygen Saturation < 75%|Percentage of time spent with arterial oxygen saturation < 75%|24 hours||||% of time||Inter-Quartile Range|Median
2643571|NCT01727414|Primary|ADHD Total Symptom Score|"Assessed via parent and teacher-completed Vanderbilt ADHD Rating Scales which were administered at the end of each the 4 weeks of the titration trial.~Range: 0-54 [sum of 18 symptom items, rated from 0 (none), 1 (occasionally), 2 (often), 3 (very often)], higher scores indicate more ADHD symptoms Note to address Review Comment: During the 4 week titration trial, the placebo condition and each of the three active dosages (low, medium, and high) were given for one week each. Because the placebo and active dosages were given in random order to preserve the triple blind, all participants did not receive the same order of dosages and it is not possible to connect the connect the dosages (placebo, low dose MPH, medium dose MPH, high dose MPH) to a specific week number (week 1, week 2, week 3, week 4) which would hold for ALL participants. That is why Timeframe was revised from week 1, week 2, week 3, week 4 to placebo, low dose, medium dose, and high dose week."|End of placebo dose week, End of low dose week, End of medium dose week , End of high dose week||||units on a scale||Standard Deviation|Mean
2643572|NCT01727297|Secondary|Actions Taken in Response to Awareness of AF|Clinical actions taken in response to clinician awareness of a patient's AF onset or progression will be summarized|Time from first identified episode of AF to study exit (maximum of 30 months)|"Each visit represents the number of subjects who had a 1st, 2nd, 3rd visit, etc. in which AF was identified by the physician. Subjects in the Sixth Visit with AF Detected column had 6 visits in which AF was detected by the physician, and the column reflects the actions taken at that sixth visit."|||Actions at Visits|Actions at Visits||Count of Units
2643573|NCT01727297|Secondary|Predictors of the Incidence of AF|AF will be defined as in the primary outcome. Baseline characteristics including demographics, medical history, and biomarkers at enrollment will be tested for their association with a patient's risk of developing AF.|Time from implant to date of last stored available device data (maximum of 30 months)|This analysis only included patients who received an implantable cardiac monitor, were not on antiarrhythmic medications at baseline, and had device data available. Of the 395 participants who underwent an implant attempt, 1 attempt was unsuccessful, 1 subject was on antiarrhythmic medication, and 2 subjects had no post-implant device data.|||Participants|||Count of Participants
2643574|NCT01727297|Primary|18 Month Incidence Rate of Atrial Fibrillation (AF) Lasting Six or More Minutes|Incidence of adjudicated AF lasting six or more minutes at 18 months. Each arrhythmic episode detected by the patient's Reveal device will be reviewed to determine if it is 1) an actual atrial fibrillation episode, and (2) is at least 6 minutes in duration. The first such episode per patient occurring within 18 months will be utilized to determine the 18 month incidence rate.|Implant to 18 months post device insertion|This analysis only included patients who received an implantable cardiac monitor, met all inclusion/exclusion criteria, and had device data available. Of the 395 participants who underwent an implant attempt, 1 attempt was unsuccessful, 7 subjects did not meet all inclusion/exclusion criteria, and 2 subjects had no post-implant device data.|||percent of participants|||Number
2645430|NCT01710839|Secondary|Foveal Avascular Zone|Assess change in foveal avascular zone area and largest diameter, measured during the early phase of the angiogram|12 months|Analysis of this outcome measure is still in progress. Data will be reported when the analysis is completed.||||||
2643575|NCT01727258|Secondary|Mean Cold Air Stimulus VAS Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2643576|NCT01727258|Secondary|Mean Cold Air Stimulus VAS Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2643577|NCT01727258|Secondary|Mean Tactile Sensitivity VAS Score at Week 4|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2643578|NCT01727258|Secondary|Mean Tactile Sensitivity VAS Score at Week 2|Tooth sensitivity was measured using a Visual Analogue Scale (VAS). At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2643579|NCT01727258|Primary|Mean Tactile Sensitivity Score at Week 2|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||grams of force||Standard Error|Least Squares Mean
2643580|NCT01727258|Primary|Mean Tactile Sensitivity Score at Week 4|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||grams of force||Standard Error|Least Squares Mean
2643581|NCT01727180|Primary|Visual Analog Scale (VAS)|A visual analog scale (VAS) measuring the general severity of pruritus was reported from 0 to 10 (0 = no pruritus, 10 = worst pruritus imaginable|Once at the entry of the study||||units on a scale||Standard Deviation|Mean
2643582|NCT01727167|Secondary|Compare Blood to Right Atrial Tissue Biochemical Markers of Mitochondrial Biogenesis|Biochemical markers in both right atrial tissue and blood will be measured and compared to see if the more easily obtained blood markers accurately describe changes expected in the heart.|on week|Molecular data was not collected for the single enrolled participant.||||||
2643583|NCT01727167|Primary|Biochemical Markers for Mitochondrial Biogenesis (Blood and Right Atrial Tissue)|Right atrial biochemical markers will be measured one time only, intra-operatively. Blood Biochemical markers will be measured before CO exposure and at intervals up to one week post-operatively|2 weeks|Molecular data was not collected for the single enrolled participant.||||||
2643584|NCT01727154|Primary|The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T).|The primary immune response analysis population will include all subjects who receive all 3 infusions of sipuleucel-T. The primary analysis will measure the percentage of subjects who exhibit any immune response at any post-treatment time point (6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T).|Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T.|This study was terminated early due to administrative reasons. A min of 200 patients were needed to obtain reliable data but only 139 were enrolled, 123 treated only 118 had analyzable immune response samples. Therefore this was a descriptive analysis of only 118pts with an immune response after dosing with Provenge. No comparative group available.|||Participants|||Count of Participants
2643993|NCT01722292|Secondary|Phase 2: Number of Participants With a Complete or Partial Tumor Response (Overall Response Rate)||Randomization to Study Completion (Estimated as 38 Months)|Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.||||||
2643585|NCT01727141|Secondary|Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score|The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.|BL, 12 Weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
2643586|NCT01727141|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication|Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours. A negative change from baseline indicates improvement.|BL, 12 Weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.|||Number of puffs||Standard Error|Least Squares Mean
2643587|NCT01727141|Secondary|Transitional Dyspnea Index (TDI) Focal Score|The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.|BL, 12 weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 scores, were included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
2643588|NCT01727141|Secondary|Change From Baseline in Standardized FEV1 AUC (0-4 h), FEV1 AUC (4-8h), FEV1 AUC (8-12h) and FEV1 AUC (0-12 h)|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.|BL, day 1, week 12|Full Analysis Set: The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.|||Liters||Standard Error|Least Squares Mean
2643589|NCT01727141|Secondary|Change From Baseline in FVC|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min;Day 2: 23h15min, 23h45min;Day 15: -45min, -15min, 1h;Day 29: -45 min, -15min, 1h;Day 57: -45min, -15min, 1h;Day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h 55min;Day 86: 23h15min; 23h45min|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.|||Liters||Standard Error|Least Squares Mean
2643590|NCT01727141|Secondary|Change From Baseline in FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|BL, Day 1:5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min;Day 2: 23h15min, 23h45min;Day 15: -45min, -15min, 1h;Day 29: -45 min, -15min, 1h;Day 57: -45min, -15min, 1h;Day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55min;Day 86: 23h15min; 23h45min|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.|||Liters||Standard Error|Least Squares Mean
2643591|NCT01727141|Secondary|Change From Baseline in Pre-dose Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Pre-dose trough FEV1 was analyzed using the same MMRM as specified for FEV1. Pre-dose trough FEV1 was defined as the mean of FEV1 at -45 min and -15 min before the morning dose. Since the time of evening dose of the previous day was not recorded at these visits, no time window was applied.|BL, day 85|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2643592|NCT01727141|Secondary|Change From Baseline in Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Trough FEV1 was analyzed using the same MMRM as specified for FEV1. Trough FEV1 was defined as the mean of FEV1 at 23 h 15 min and 23 h 45 min after the morning dose of the previous day. Before the mean was calculated, a time window of 10 - 13 hours post-evening dose was applied to these 2 measurements. Recordings outside the time window were set to missing.|BL, day 2, day 86|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.|||Liters||Standard Error|Least Squares Mean
2643593|NCT01727141|Secondary|Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score|"Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status."|12 weeks|Participants from the full analysis set, who had a SGRQ total score, were included in the analysis. The full analysis set included all randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2643594|NCT01727141|Secondary|Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score|"Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. Missing week 12 data were imputed with Last Observation Carried Forward (LOCF) method but only if measured at day >= 29. A negative change from baseline indicates improvement."|BL, 12 Weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants missing week 12 data were not included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
2643595|NCT01727141|Primary|Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. Missing values of FEV1 AUC0-12 at Day 1 and Week 12 will not imputed. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.|baseline (BL), 12 Weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants, who were missing day 1 and/or week 12 FEV1 AUC 0-12h measurements, were not included in the analysis.|||Liter||Standard Error|Least Squares Mean
2643596|NCT01727089|Secondary|Number of Participants With Overall Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|From time of treatment initiation until conclusion of treatment, assessed every 12 weeks.||||participants|||Number
2643597|NCT01727089|Secondary|Number of Participants With Grade 3 and Above Adverse Events (AE) Related to Treatment|"The descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 will be utilized for AE reporting.~Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.~Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL).~Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.~Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related adverse event."|From time of treatment initiation until 30 days post treatment, assessed every 4 weeks.||||participants|||Number
2643598|NCT01727089|Primary|Progression-free Survival at 12 Weeks|Progression-free survival 12 after starting treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|The duration of time from start of treatment to time of progression or death, assessed at 12 weeks||||percentage of participants||95% Confidence Interval|Number
2643599|NCT01727089|Primary|Progression-free Survival at 24 Weeks|Progression-free survival 24 after starting treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|The duration of time from start of treatment to time of progression or death, assessed at 24 weeks||||percentage of participants||95% Confidence Interval|Number
2643600|NCT01727024|Secondary|Number of Participnats With Difficulties Experienced When Handling the Devices|Participants used a patient diary to report difficulties with handling the device. Thirteen difficulty categories were assessed.|1 week|The safety analysis set, which included participants who received at least one dose of study medication, was considered for the analysis. However, only participants who had observed values, were analyzed.|||Participants|||Number
2643601|NCT01727024|Secondary|Number of Participants With Preference for Either Device|Participants answered a single question to determine their device preference.|day 7|The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with preference responses values were analyzed.|||Participants|||Number
2643602|NCT01727024|Secondary|Mean Score of the Feeling of Satisfaction With the Inhaler (FSI-10) Questionnaire|"Participants completed the FSI-10 questionnaire to assess their satisfaction with the devices.~The questionnaire contained 10 questions. each one with 5 possible answers in a Likert scale from 5 (a lot) to 1 (almost nothing). The total overall satisfaction score ranged from 0 - 50. Higher values indicated greater satisfaction"|day 7|The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with observed values were analyzed.|||score on a scale||Standard Deviation|Mean
2643604|NCT01727024|Primary|Number of Participants Who Correctly Used the Device at the Start of Handling the Device|The correct use of 2 drug delivery systems was measured. Participants were given written instructions prior to the first treatment at day one and a check list was used to report the proper handling of the devices.|day 1|The full analysis set, which included the eligible randomized participants, was considered for the analysis. However, only participants with day 1 values were analyzed.|||Participants|||Number
2643605|NCT01726803|Secondary|Lost Work Time|Missed work due to LBP|12 months||||participants|||Number
2643606|NCT01726803|Secondary|Pain Catastrophizing|13-item Pain Catastrophizing Scale assessing the extent of catastrophizing thinking is response to pain. Each item is scored 1-4 for a total score of 13-52. Higher numbers indicate greater levels of catastrophizing.|3 months||||units on a scale||95% Confidence Interval|Mean
2643607|NCT01726803|Secondary|Health Care Utilization (MRI)|Utilization of healthcare for low back pain (MRI utilization)|12 months||||participants|||Number
2643608|NCT01726803|Secondary|Patient Global Rating of Improvement (Percentage of Participants Reporting Successful Outcome)|"15-point patient global rating scale. Patient is asked to rate current condition relative to condition at the beginning of treatment on a scale ranging from A Very Great Deal Worse to A Very Great Deal Better. Higher numbers indicate greater self-rating. Those rating at least 12 are considered successful as a dichotomous outcome."|3 months||||percentage of participants|||Number
2643609|NCT01726803|Secondary|Fear-Avoidance Beliefs Questionnaire (Work Subscale)|Measures fear-avoidance beliefs related to work. Scores range from 0-42 with higher numbers representing greater levels of fear avoidance beliefs about work.|3 months||||units on a scale||95% Confidence Interval|Mean
2643610|NCT01726803|Secondary|EQ-5D|European Quality of Life Measure, assesses general quality of life. Scores are expressed on a scale from 0 - 1.0 with higher scores representing greater quality of life.|3 months||||units on a scale||95% Confidence Interval|Mean
2643611|NCT01726803|Secondary|Numeric Pain Rating|0-10 numeric rating of low back pain intensity, score range from 0-10 with higher numbers indicating greater pain intensity.|3 months||||units on a scale||95% Confidence Interval|Mean
2643612|NCT01726803|Primary|Oswestry Disability Index|10-item Oswestry Disability Index assessing low back pain-related disability. Scores range from 0-100 with higher numbers indicating greater disability.|3 months||||units on a scale||95% Confidence Interval|Mean
2643613|NCT01726673|Secondary|Median Change in Motor Power Manual Muscle Test Score for the Upper Extremity (MRC)|The median change in Motor Power Manual Muscle Test Score for the upper extremity was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Motor Power Manual Muscle Test Score is reported here, with a range 0-100 points, and with higher values indicating better functional status.|12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention)|45 patients completed 36 sessions (3x/week for 12 weeks) of robotic arm training + sham or active tDCS, and 6 month follow-up at 36 weeks. These 45 participants were consequently included in the efficacy analysis.|||scores on a scale||Inter-Quartile Range|Median
2643614|NCT01726673|Secondary|Median Change in WOLF Motor Function Test (WMFT)|The median change in performance time for the WOLF motor function test was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total WOLF motor function timed score is reported here in seconds, with a range 0-1800 seconds, and with lower values indicating faster completion of task and better functional status.|baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention)|45 patients completed 36 sessions (3x/week for 12 weeks) of robotic arm training + sham or active tDCS, and 6 month follow-up at 36 weeks. These 45 participants were consequently included in the efficacy analysis.|||seconds||Inter-Quartile Range|Median
2643615|NCT01726673|Primary|Median Change in Upper Extremity Fugl Meyer Assessment Score|The median change in Upper Extremity Fugl-Meyer Score was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Upper Extremity Fugl Meyer score is reported, with a range 0-66 points, and with higher values indicating better functional status.|baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention)|45 patients completed 36 sessions (3x/week for 12 weeks) of robotic arm training + sham or active tDCS, and 6 month follow-up at 36 weeks. These 45 participants were consequently included in the efficacy analysis.|||scores on a scale||Inter-Quartile Range|Median
2643616|NCT01726621|Primary|User Acceptance of the New MiniMed 620G and 640G Insulin Pumps and Guardian Link Transmitter|Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 620G, 640G, and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.|Four weeks of pump wear||||units on a scale||Standard Deviation|Mean
2643617|NCT01726517|Secondary|Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse|"Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.~Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement."|Baseline to Posttreatment Week 24||||percentage of participants|||Number
2643618|NCT01726517|Secondary|Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)|SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA < LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 2, 4, 8, and 24|Full Analysis Set|||percentage of participants|||Number
2643619|NCT01726517|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized.|Baseline to Week 12|Safety Analysis Set|||participants|||Number
2643620|NCT01726517|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants were randomized and received at least 1 dose of study drug|||percentage of participants|||Number
2643621|NCT01726504|Secondary|Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used|Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.|1-20 weeks||||percentage of participants|||Number
2643622|NCT01726504|Secondary|The Number of Participants Using Rescue Medicine for Constipation||1-20 weeks||||participants|||Number
2643623|NCT01726504|Secondary|Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used|Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.|1-20 weeks||||number of times per week||Standard Error|Mean
2643624|NCT01726504|Secondary|Number of Participants With Adverse Events Related to Acupuncture||1-8 weeks||||participants|||Number
2643625|NCT01726504|Secondary|Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL)|Patient-Assessment of Constipation Quality Of Life(PAC-QOL) ranges are 28-140,and higher values represent a worse outcome.Subscales are summed to compute the total score. The changed score of PAC-QOL at week 8, compared with baseline.|baseline and the end of 8th week||||score on a scale||Standard Error|Mean
2643626|NCT01726504|Secondary|Change of Average Weekly Degree of Difficulty in Defecation From Baseline|"The degree of straining during self-defecation: The severity of straining is graded using a 4-point ordinal scale.~0 = not at all~= more straining than not~= a great deal~= an extreme amount, need finger manipulation to defecate average weekly degree of difficulty in self-defecation during 1-8weeks,compared with baseline"|Baseline and weeks 1-8||||scores on a scale||Standard Error|Mean
2643627|NCT01726504|Secondary|Mean Scores for Stool Consistency and Straining During Weeks 1-8|average weekly stool consistency (Bristol Stool Scale) assessment of self-defecation during the 1-8weeks of treatment,compared with baseline. Bristol Stool Scale including 7-type, scored by 1 to 7 respectively.Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (passed easily); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces. Entirely liquid. Type 3, 4 are normal.|Baseline and weeks 1-8||||score on a scale||Standard Error|Mean
2643628|NCT01726504|Secondary|Mean Weekly SBMs During Weeks 1-8|The changed number in mean of weekly average SBMs (spontaneous bowel movement) during 8-week treatment, compared with baseline.|Baseline and weeks 1-8||||number of times||Standard Error|Mean
2643629|NCT01726504|Secondary|Changes in Mean Weekly CSBMs During Weeks 9-20|The changed number in mean weekly average CSBMs during 9-20th weeks, compared with baseline.|Baseline and weeks 9-20||||number of times||Standard Error|Mean
2643630|NCT01726504|Secondary|the Percentage of Participants With Three or More Weekly CSBMs|the percentage of participants with three or more weekly CSBMs during weeks 1-8 and weeks 9-20|1-20 weeks||||percentage of participants|||Number
2643631|NCT01726504|Primary|the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment|the change number in mean weekly CSBMs during weeks 1-8 since treatment compared with baseline.|Baseline and weeks 1-8||||number of times||Standard Error|Mean
2643632|NCT01726335|Secondary|Global Assessment of Functioning (GAF) Scale Score|The GAF scale is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.|Screening, and Week 8, 16, 24, 38 and 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
2643633|NCT01726335|Secondary|Personal and Social Performance (PSP) Scale Score|The PSP scale assesses the degree of a participant's dysfunction (ranging from i [absent] to vi [very severe) within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behavior. The overall score ranges from 1 to 100. Based on the 4-domains there was one total score. Participants with a score of 71 to 100 had a mild degree of difficulty; from 31 to 70, varying degrees of disability; participants with scores of 30 or less function so poorly as to require intensive supervision.|Screening, and Week 8, 16, 24, 38 and 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
2643634|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 50|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
2660061|NCT01584388|Secondary|Complete Remission IgG-RD RI (Exclusive of Serum IgG4) of 0 at 6 Months.|IgG-RD RI (exclusive of serum IgG4) of 0 at 6 months.|6 months||||Participants|||Count of Participants
2643635|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 38|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 38|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
2643636|NCT01726335|Secondary|Short Form-36 (SF-36) - Quality of Life|The SF-36 is a survey of participant health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.|Baseline and Week 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Deviation|Mean
2643637|NCT01726335|Secondary|Drug Attitude Inventory (DAI-10)|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Screening, and Week 8, 24 and 50|ITTs population included all the Participants who received at least one dose of study medication and were reassessed after the start of use. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Units on a scale||Standard Error|Mean
2643638|NCT01726335|Secondary|Extrapyramidal Symptoms Rating Scale (ESRS) Total Score|The ESRS is used to assess four types of drug-induced movement disorders administered as a questionnaire. Score range from 0 to 6 (0 is absent and 6 is extremely severe).|Baseline and Week 2, 4, 8, 16, 24 and 50|Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use. 'N' (number of participants analyzed) signifies the participants evaluable for this measure.|||Units on a scale||Standard Error|Mean
2643639|NCT01726335|Secondary|Clinical Global Impressions (CGI) - Disease Severity Score|"The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 indicates to normal, not at all ill and a rating of 7 indicates among the most extremely ill participants. Higher scores indicate worsening."|Baseline and Week 2, 4, 8, 16, 24, 38 and 50|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
2643640|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 24|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
2643641|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 16|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 16|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
2643642|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 8|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 8|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
2643643|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 4|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 4|The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
2643644|NCT01726335|Primary|Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Week 2|Intent-to-treat-efficacy evaluation (ITTe) population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.|||Units on a scale||Standard Error|Mean
2643994|NCT01722292|Secondary|Phase 2: Percent Change in Tumor Size (CTS)||Randomization to End of Cycle 2 (Estimated as 24 Months)|Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.||||||
2643645|NCT01726270|Secondary|Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population|"Percentage of participants who have a correct self-selection response as defined by the Uses, Allergy alert, and Do Not Use sections of the Drug Facts Label."|8 weeks|Evaluable Analysis Set for Self-Selection (EVAL-SS), all subjects who answered the self-selection question, probing question and followup questions.|||Percentage of participants||95% Confidence Interval|Number
2643646|NCT01726270|Secondary|Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population|Percentage of participants who are potentially at risk of harm by incorrectly selecting to use the study product out of the total study population|8 weeks|Evaluable Analysis Set for Self-Selection (EVAL-SS), all subjects who answered the self-selection question, probing question and followup questions.|||Percentage of participants||95% Confidence Interval|Number
2643647|NCT01726270|Secondary|Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase|"Includes participants who:~were less than 45 years of age at enrollment, and~spoke to a doctor during the actual use phase."|8 weeks|Full Analysis Set for Actual Use Study- Under 45 years (FAS-AUS45), all subjects less than 45 years of age who self-selected to use the product, purchased the product, took at least one dose of the product and participated in at least one phone interview|||Percentage of participants|||Number
2643648|NCT01726270|Secondary|"Percentage of Use-Days for All Participants Who Took no More Than One Capsule Per Day"|"Use-day was defind as a calendar day for which data were available regarding use or non-use."|8 weeks|Full Analysis Set for Actual Use Study (FAS-AUS), all subjects who self-selected to use the product, purchased the product, took at least one dose of the product and participated in at least one phone interview|||Percentage of participants||95% Confidence Interval|Number
2643649|NCT01726270|Secondary|Percentage of Participants Who Took no More Than One Capsule Per Day|Percentage of participants who took no more than one capsule per day|8 weeks|Subjects who completed all three telephone follow-up interviews out of the FAS population|||Percentage of participants||95% Confidence Interval|Number
2643650|NCT01726270|Primary|Percentage of Participants Who Appropriately Followed the Label Instructions|"Includes subjects who reported:~No improvement in urinary symptoms and stopped taking product,~Reported worsening of urinary symptoms and stopped taking the product,~Reported a new urinary symptom and stopped taking the product,~Reported no Stop Use condition and never took more than 1 capsule on any given day,~Reported a Stop Use condition and contacted a provider."|8 weeks|Full Analysis Set for Actual Use Study (FAS-AUS), all subjects who self-selected to use the product, purchased the product, took at least one dose of the product and participated in at least one phone interview.|||Percentage of participants|||Number
2643651|NCT01726049|Other Pre-specified|Echocardiographic Parameters of Diastolic LV Dysfunction||12 weeks|||||||
2643652|NCT01726049|Secondary|Wedge Pressure Measured Invasively by Right Heart Catheterization|Difference in change of wedge pressure between baseline and 12 weeks between Sildenafil group and Placebo group|baseline and 12 weeks|52 patients randomized. 26 Sildenafil arm: 26 placebo arm: change in wedge pressure could be evaluated in the ITT analyses in 21 and 22 subjects of the Sildenafil and placebo treatment group|||mmHg||95% Confidence Interval|Mean
2643653|NCT01726049|Secondary|Cardiac Output Measured Invasively by Right Heart Catheterization|difference in change of cardiac output between baseline and 12 weeks between Sildenafil and Placebo group|baseline and 12 weeks|52 patients randomized. 26 Sildenafil arm: 26 placebo arm: change in cardiac output could be evaluated in the ITT analyses in 20 and 22 subjects of the Sildenafil and placebo treatment group|||mililiter/min||95% Confidence Interval|Mean
2643654|NCT01726049|Secondary|VO2max|difference in change of VO2 max between baseline and 12 weeks between Sildenafil and placebo group|baseline and 12 weeks|52 patients randomized. 26 Sildenafil arm: 26 placebo arm: change in VO2max could be evaluated in the ITT analyses in 18 and 22 subjects of the Sildenafil and placebo treatment group|||ml/kg/min||95% Confidence Interval|Mean
2643655|NCT01726049|Primary|Mean Pulmonary Artery Pressure Measured by Right Heart Catheterization|change of mean pulmonary artery pressure between baseline and 12 weeks measured by heart catheterisation|baseline and 12 weeks|52 patients randomized. 26 Sildenafil arm: 26 placebo arm: change in mean pulmonary artery pressure could be evaluated in the intention to treat (ITT) analyses in 21 and 22 subjects of the Sildenafil and placebo treatment group|||mmHG||95% Confidence Interval|Mean
2643656|NCT01726036|Primary|Post-procedure Neonatal Pain Score Using the CRIES Neonatal Pain Measurement Tool|The CRIES score assigns points for crying characteristics, oxygen requirements, change in vital signs, facial expressions, and the infant's sleep state. The minimum and maximum scores of CRIES is 0 to 10, respectively with the lower score associated with lower pain and the higher score associated with high amount of pain.|CRIES assessment completed prior to the procedure and post procedure.||||units on a scale||Full Range|Median
2643657|NCT01726036|Primary|Neonatal Salivary Cortisol Level|Neonatal pain will be assessed by change in salivary cortisol, measured in mcg/dL., level pre and post procedure|Approximately 2 hours before and 15 minutes after the procedure||||mcg/dL||Standard Deviation|Mean
2643658|NCT01726023|Secondary|Plasma Concentrations for Ceftazidime and Avibactam|Blood samples were taken from all patients on Day 3 for the pharmacokinetic evaluation of ceftazidime and avibactam plasma concentrations|At Day 3: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug.|PK analysis set|||ng/mL||Full Range|Geometric Mean
2643659|NCT01726023|Secondary|Safety and Tolerability:ECG , QTcB and QTcF Intervals|Shifts in ECG interpretation and changes in QT, QTcB, and QTcF intervals , from baseline to post baseline.|EOT visit/any observation on treatment|Safety analysis set: all patients who received at least 1 dose of IP|||Number of patients|||Number
2643660|NCT01726023|Secondary|Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry.|Potentially clinically significant (PCS) post Baseline clinical chemistry values up to LFU (Safety analysis set)|study duration (from screening to Day 49 LFU visit)|Safety analysis set: all patients who received at least 1 dose of IP|||Number of patients|||Number
2643661|NCT01726023|Secondary|Safety and Tolerability: Clinical Laboratory Evaluation Hematology.|Potentially clinically significant (PCS) post Baseline hematology values up to LFU (Safety analysis set)|study duration (from screening to Day 49 LFU visit)|Safety analysis set: all patients who received at least 1 dose of IP|||Number of patients|||Number
2643662|NCT01726023|Secondary|Safety and Tolerability by Incidence: Extent of Exposure.|Duration of exposure is calculated as the difference between the last study therapy date and the first study therapy date converted to days plus 1 day. Actual calculated duration could be shorter or longer than a full day.|study duration (from screening to Day 49 LFU visit)|Safety analysis set: all patients who received at least 1 dose of IP|||Number of patients|||Number
2643663|NCT01726023|Secondary|Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality.|Adverse event data were collected from the screening/consent visit until the late follow-up visit (i.e. Day -1/0 to Day 42).|study duration (from screening to Day 49 LFU visit)|Safety analysis set: all patients who received at least 1 dose of IP|||Number of patients|||Number
2643664|NCT01726023|Secondary|The Time to First Defervescence in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set for Patients Who Have Fever at Study Entry.|Time to first defervescence was calculated for patients with a fever (>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.|while on study therapy (from Day 1 to Day 14)|microbiological modified intent-to-treat (mMITT) with fever, defined as >38ºC at study entry. No participants were censored at the time of last observation.|||Days||Full Range|Median
2643665|NCT01726023|Secondary|The Time to First Defervescence in the Clinically Evaluable (CE) Analysis Set for Patients Who Have Fever at Study Entry.|Time to first defervescence was calculated for patients with a fever (>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.|while on study therapy (from Day 1 to Day 14)|Clinically evaluable (CE) with fever, defined as >38ºC at study entry. No participants were censored at the time of last observation.|||Days||Full Range|Median
2643666|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set.|"The microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)."|At the test of cure (TOC) (Day 28 to 35)|Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Number of patients|||Number
2643667|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set.|"The microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)."|At the test of cure (TOC) (Day 28 to 35)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Number of patients|||Number
2643668|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|"The microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)."|At the test of cure (TOC) (Day 28 to 35)|The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Number of patients|||Number
2643669|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the late follow up (LFU) (Day 42 to 49)|Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Participants with favorable responses|||Number
2643995|NCT01722292|Secondary|Phase 2: Overall Survival||Randomization to Study Completion (Estimated as 38 Months)|Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.||||||
2643670|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the test of cure (TOC) (Day 28 to 35)|Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Participants with favorable responses|||Number
2643671|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the end of treatment (EOT) (within 24 hours after last IV dose)|Extended microbiologically evaluable(ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Participants with favorable responses|||Number
2643672|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the late follow up (LFU) (Day 42 to 49)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Participants with favorable responses|||Number
2643673|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the test of cure (TOC) (Day 28 to 35)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Participants with favorable responses|||Number
2643674|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the end of treatment (EOT) (within 24 hours after last IV dose)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Participants with favorable responses|||Number
2643675|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the late follow up (LFU) (Day 42 to 49)|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants with favorable responses|||Number
2643676|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the test of cure (TOC) (Day 28 to 35)|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants with favorable responses|||Number
2643677|NCT01726023|Secondary|The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|At the end of treatment (EOT) (within 24 hours after last IV dose)|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants with favorable responses|||Number
2643949|NCT01722994|Secondary|Presence of Infection|Any infected wounds were documented. A scale of 0-1 was used (0=absence; 1= present).|1 week|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.|||participants|||Number
2643678|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the late follow up (LFU) (Day 42 to 49)|The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Number of patients|||Number
2643679|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the test of cure (TOC) (Day 28 to 35)|The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Number of patients|||Number
2643680|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the end of treatment (EOT) (within 24 hours after last IV dose)|The microbiological modified intent-to-treat (mMITT) analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Number of patients|||Number
2643681|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the late follow up (LFU) (Day 42 to 49)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Number of patients|||Number
2643682|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the test of cure (TOC) (Day 28 to 35)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Number of patients|||Number
2643683|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the end of treatment (EOT) (within 24 hours after last IV dose)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Number of patients|||Number
2643684|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the late follow up (LFU) (Day 42 to 49)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Number of patients|||Number
2643685|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the test of cure (TOC) (Day 28 to 35)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Number of patients|||Number
2643686|NCT01726023|Secondary|The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.|"Per-patient favorable response indicates that all of the patient's baseline pathogens are eradicated or presumed eradicated."|At the end of treatment (EOT) (within 24 hours after last IV dose)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Number of patients|||Number
2643687|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At late follow up (LFU) visits (Day 42 to 49)|The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.|||Number of patients|||Number
2643725|NCT01725750|Primary|Multidimensional Assessment of Fatigue (MAF)|Multidimensional Assessment of Fatigue (MAF) yields a Global Fatigue Index (GFI), assessing 5 dimensions of fatigue: distress, degree, severity, impact on ADLs and frequency of fatigue in the past week, and it yields a composite score. GFI full score from 0-50, with a higher score indicating more severe fatigue, fatigue distress, or impact on activities of daily living.|baseline, 4 weeks, 8 weeks||||score on a scale||Standard Deviation|Mean
2643688|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the end of treatment (EOT) (within 24 hours after last IV dose)|The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.|||Number of patients|||Number
2643689|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the late follow up (LFU) (Day 42 to 49)|The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Number of patients|||Number
2643690|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the test of cure (TOC) (Day 28 to 35)|The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Number of patients|||Number
2643691|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the end of treatment (EOT) (within 24 hours after last IV dose)|The microbiological modified intent-to-treat mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Number of patients|||Number
2643692|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the late follow up (LFU) (Day 42 to 49)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Number of patients|||Number
2643693|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the test of cure (TOC) (Day 28 to 35)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Number of patients|||Number
2643694|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the end of treatment (EOT) (within 24 hours after last IV dose)|Extended microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture regardless of susceptibility.|||Number of patients|||Number
2643695|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the late follow up (LFU) (Day 42 to 49)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Number of patients|||Number
2643696|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the test of cure (TOC) (Day 28 to 35)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Number of patients|||Number
2643697|NCT01726023|Secondary|The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the end of treatment (EOT) (within 24 hours after last IV dose)|Microbiologically evaluable (ME) analysis set defined as all patients included in the clinically evaluable (CE) set with at least 1 Gram-negative aerobic pathogen in the initial/prestudy culture that was susceptible to both treatment groups.|||Number of patients|||Number
2643698|NCT01726023|Primary|The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set.|The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|At the test of cure visit (Day 28 to35)|The clinically evaluable (CE) analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.|||Number of patients|||Number
2643699|NCT01725984|Primary|Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use|"Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:~0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);"|Prospective follow-up to 36 Months Post Procedure||||percentage of subjects|||Number
2643700|NCT01725984|Primary|Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use|"Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:~0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);"|3 Months Post Procedure||||percentage of subjects|||Number
2643701|NCT01725984|Primary|Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use|Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit|Prospective follow-up to 36 Months Post Procedure||||percentage of subjects|||Number
2643702|NCT01725984|Primary|Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use|Evaluate the proportion of subjects with a ≥50% reduction in pads per day use|Prospective follow-up to 36 Months Post Procedure||||percentage of subjects|||Number
2643703|NCT01725984|Primary|Number of Adverse Events Reported Between Arms|Evaluate the occurrence of all AdVance /AdVance XP AEs, as well as those reported as serious, intra-operative, device or procedure related adverse events|Prospective follow-up to 36 Months Post Procedure||||Adverse Events|||Number
2643704|NCT01725984|Primary|Change in Quality of Life Scores as Compared to Baseline for I-QOL, ICIQ-SF, and Summary of Values for the PGI-I. Measured From Baseline to Prospective Follow.|"The Incontinence Quality of Life Questionnaire (I-QOL) is a 22 questionnaire that evaluates a subject's quality of life with respect to urinary problems/incontinence. A lower score correlates with more severe incontinence, and an increase from baseline indicates an improvement in quality of life. The score scale is 0 - 100.~The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is a 4 question tool that quantifies the impact on quality of life from incontinence. A decrease from baseline to follow-up indicates an improvement in quality of life. The score scale is 1-21.~The Patient Global Impression of Improvement (PGI-I) questionnaire is a single question instrument that assess a subject's perception of the disease impact on their quality of life. Completed at the last visit, a lower score indicates a better perception from the patient. Scale from 1 to 7."|Baseline to Prospective Follow Up (up to 36 months)||||Score on a scale||Standard Deviation|Mean
2643705|NCT01725984|Primary|Evaluate the 24-hour Pad Weight at the Final Prospective Follow-up Visit|Percentage of subjects at a given weight for their 24-hour pad weight test at the final prospective follow-up visit.|Prospective follow-up to 36 Months Post Procedure||||percentage of subjects|||Number
2643706|NCT01725984|Primary|Percentage of Subjects in Each Pre-defined Range of Pads Per Day Use|"Evaluate the proportion of subjects using the following categories of pads per day at the three month and final prospective follow-up visit:~0 pads per day or 1 dry prophylactic pad; 1 pad per day; 2 pads per day; 3 pads per day; 4 pads per day; 5 or more pads per day (5, 6, 7, 8 etc. pads per day);"|Baseline||||percentage of subjects|||Number
2643707|NCT01725984|Primary|Percentage of Subjects Cured, Improved, or Failed Based on Reported Pad Per Day Use|Evaluate the proportion of subjects cured (0 pads per day or 1 dry prophylactic pad), improved (not cured and ≥50% reduction in pad use), or failed (not cured and not improved) at the three month and final prospective follow-up visit|3 months Post Procedure||||percentage of subjects|||Number
2643708|NCT01725984|Primary|Percentage of Subjects With a ≥50% Reduction in Pads Per Day Use|Evaluate the proportion of subjects with a ≥50% reduction in pads per day use|3 Months Post Procedure||||percentage of participants|||Number
2643709|NCT01725815|Secondary|Medication Adherence|Medication Adherence was assessed using the Morisky scale, a 4-item questionnaire that has been shown to have strong content and predictive validity in hypertension,cardiovascular disease,and diabetes. Possible scores range from 0 to 4 with lower scores indicating greater medication adherence.|Baseline, 3 months post-intervention, 6 months post-intervention||||score on a scale||Standard Deviation|Mean
2643710|NCT01725815|Secondary|Dietary Intake|Dietary intake was assessed with the Block Fat-Sugar-Fruit-Vegetable Screener, which is a validated 55-item scale assessing both frequency and quantity of food intake based on typical eating habits. Possible scores range from 0 to 68, with higher scores indicating greater consumption of fat (worse outcome).|Baseline, 3 months post-intervention, 6 months post-intervention||||score on a scale||Standard Deviation|Mean
2643711|NCT01725815|Secondary|Behavioral Activation|Behavioral Activation was measured using the Patient Activation Measure (PAM), an instrument which has been found to be reliable and valid across a wide range of patient populations. The Patient Activation Measure (PAM) is a 22-item measure that assesses patient knowledge, skill, and confidence for self-management. Possible scores range from 0 to 100, with higher scores indicating greater patient activation (better outcome).|Baseline, 3 months post-intervention, 6 months post-intervention||||score on a scale||Standard Deviation|Mean
2643712|NCT01725815|Primary|Health Related Quality of Life (HRQOL)|The short form-36-item (SF-36) Physical component score (PCS) is a measure of HRQOL constructed for use in the Medical Outcomes Study that rely upon patient self-reporting and reflects the physical functioning. The scores ranges from 0-100 with higher scores indicating greater levels of physical functioning.|Baseline, 3 months post-intervention, 6 months post-intervention||||score on a scale||Standard Deviation|Mean
2645431|NCT01710839|Secondary|Retinal Ischemia|Quantify change in area of perfused and ischemic retina.|12 month period|Analysis of this outcome measure is still in progress. Data will be reported when the analysis is completed.||||||
2643713|NCT01725750|Secondary|Credibility/Expectancy Questionnaire|Assess treatment credibility (BWL vs. DRL) with the Credibility/Expectancy Questionnaire (CEQ), used in clinical outcome studies. The CEQ utilizes two scales during the administration (1-9, and 0-100%), and so a composite z score was derived for each factor (expectancy and credibility) by first standardizing the individual items and then summing those items for each factor. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. A higher score indicates more belief or feeling of reduction in anxiety.|at 4 weeks (end-of-treatment)|Compared to other outcome measures, fewer CEQ records were analyzed due to participant non-compliance.|||score on a scale||Standard Deviation|Mean
2643714|NCT01725750|Secondary|Treatment Satisfaction Questionnaire for Medication|An adapted version of the Treatment Satisfaction Questionnaire for Medication (TSQM). This is a validated, psychometrically sound measure of general treatment satisfaction. The TSQM scores range from 0 to 100 with higher scores representing higher satisfaction.|at 4 weeks (end-of-treatment)||||score on a scale||Standard Deviation|Median
2643715|NCT01725750|Secondary|Satisfaction With Life Scale|Satisfaction with Life Scale, a 5-item measure of global satisfaction with life, on likert scale from 1 strongly disagree to 7 strongly agree. Total scale from 5 to 35, with higher scores indicating more satisfaction with life, and 20 representing a neutral point on the scale.|baseline, 4 weeks, 8 weeks||||score on a scale||Standard Deviation|Mean
2643716|NCT01725750|Secondary|Actiwatch Spectrum - F Statistic|"Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep.~F statistic is an F value, so the range is 0 - infinity. It compares two different models of calculating the curve. Higher means a more rhythmic pattern."|4 weeks post treatment|After the Actigraph data were cleaned and analyzed, there was clean, usable data for 30 in the white arm and in the 23 red arm.|||score on a scale||Standard Deviation|Mean
2643717|NCT01725750|Secondary|Actiwatch Spectrum - Mesor|"Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep.~Mesor is an adjusted proportion of the difference between the minimum and half the peak, so range is 0-1. Higher means a more rhythmic pattern."|4 weeks post treatment|After the Actigraph data were cleaned and analyzed, there was clean, usable data for 30 in the white arm and 23 in the red arm.|||score on a scale||Standard Deviation|Mean
2643718|NCT01725750|Secondary|Actiwatch Spectrum - Acrophase|"Philips Actiwatch Spectrum to measure circadian rhythms; it is the size and shape of a digital wristwatch and weighs about one ounce. It is worn on an ordinary watchband and is waterproof. Data can be downloaded and analyzed using Actiware software. The Actiwatch Spectrum logs all physical movement using a piezoelectric accelerometer and detects the presence of ambient light (400-700nm), making it a useful measure of circadian cycles because it allows for accurate quantitative assessment of periods of activity, rest and sleep.~Acrophase is time of the peak activity, so it is expressed in hours. The higher the number, the later in the day the peak activity occurs."|4 weeks post treatment|After the Actigraph data were cleaned and analyzed, there was clean, usable data for 30 in the white arm and 23 in the red arm.|||hours||Standard Deviation|Mean
2643719|NCT01725750|Secondary|Neuro-QOL Anxiety|The Neuro-QOL Anxiety measure. Raw scores were converted to T-Scores; from 0-100, with a T = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating worse anxiety.|baseline, 4 weeks, 8 weeks||||T score||Standard Deviation|Mean
2643720|NCT01725750|Secondary|Cognitive Failures Questionnaire|The Cognitive Failures Questionnaire (CFQ)100 is a 25-item self-report inventory, with items measuring difficulties in several cognitive domains (e.g., memory, perception), each item scored from 0 (never) to 4 (very often), with total scale from 0 - 100, with higher score indicating worse outcome.|baseline, 4 weeks, 8 weeks||||score on a scale||Standard Deviation|Mean
2643721|NCT01725750|Secondary|CNS Vital Signs TBI Rehab Toolbox|The Centre for Neuro Skills Vital Signs TBI Rehab Toolbox is a brief, 25-minute computerized cognition battery; it emphasizes those cognitive functions that are the most likely to respond to alerting effects of light (vigilance, attention, speed) and has multiple forms for serial assessment. The scores are reported as Standard Scores, with mean = 100 and standard deviation = 15. Higher scores are correlated with better outcomes.|baseline, 4 weeks, 8 weeks||||score on a scale||Standard Deviation|Mean
2643722|NCT01725750|Secondary|Epworth Sleepiness Scale (ESS)|The Epworth Sleepiness Scale (ESS) will also be used, to assess daytime sleepiness; it is an 8-item measure that asks about the probability of dozing or sleeping during typical daytime activities and has been widely used in TBI research. Scores correlate well with objective measures of speed of daytime sleep onset. The test is a list of eight situations in which the participate rates tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing for each item. Total scale from 0 to 24, with higher score indicating severe excessive daytime sleepiness.|baseline, 4 weeks, 8 weeks||||score on a scale||Standard Deviation|Mean
2643723|NCT01725750|Secondary|Neuro-QOL Depression and Sleep|The Neuro-QOL Depression and Sleep measures the physical, mental, and social effects experienced by adults and children living with neurological conditions. Raw scores were converted to T-Scores; from 0-100, with a T = 50 indicating average function compared to the reference population and a standard deviation of 10, with a higher score indicating worse function.|baseline, 4 weeks, 8 weeks||||T-score||Standard Deviation|Mean
2643724|NCT01725750|Secondary|TBI-QOL Fatigue|The Traumatic Brain Injury-Quality Of Life Fatigue (TBI-QOL) measures form part of the Promis Neuro-QOL initiative and include well-validated self-report measures that assess the health-related QOL of individuals with neurological disorders. All TBI-QOL scores have been transformed to a T metric,from 0-100, with a mean of 50 (SD = 10), with a higher score indicating more fatigue.|baseline, 4 weeks, 8 weeks||||T score||Standard Deviation|Mean
2660062|NCT01584388|Secondary|Complete Remission|IgG4-RD RI (including serum IgG4) of 0 at six months|6 months||||Participants|||Count of Participants
2643726|NCT01725529|Secondary|Percentage of Participants With On-treatment Normalization of Alanine Aminotransferase Level|Percentage of participants with on-treatment normalization of alanine aminotransferase level were assessed.|72 weeks after the EOT (Week 24 or 48)|ITT population included all the randomized participants who took at least 1 dose of study drug. ‘N’ (number of participants analyzed) signifies those participants who were analyzed for this measure.|||percentage of participants|||Number
2643727|NCT01725529|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as undetectable HCV RNA at the actual end of treatment and last HCV RNA measurement during follow-up ≥25 IU/mL.|72 weeks after the EOT (Week 24 or 48)|ITT population included all the randomized participants who took at least 1 dose of study drug. ‘N’ (number of participants analyzed) signifies those participants who were analyzed for this measure.|||percentage of participants|||Number
2643728|NCT01725529|Secondary|Percentage of Participants With Viral Breakthrough|The number of patients who experience viral breakthrough will be determined by measuring Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in plasma. Viral breakthrough was defined as a confirmed increase of >1 log10 IU/mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of >100 IU/mL in subjects whose HCV RNA levels had previously been below the limit of quantification (<25 IU/mL detectable) or undetectable (<25 IU/mL undetectable) while on study treatment.|Week 24 or 48 (End of Treatment)|ITT population included all the randomized participants who took at least 1 dose of study drug. ‘N’ (number of participants analyzed) signifies those participants who were analyzed for this measure.|||percentage of participants|||Number
2643729|NCT01725529|Secondary|Percentage of Participants With On-treatment Failure|A participant with on-treatment failure refers to a participant with confirmed detectable HCV RNA at the end of treatment.|End of Treatment (EOT: Week 24 or 48)|ITT population included all the randomized participants who took at least 1 dose of study drug.|||percentage of participants|||Number
2643730|NCT01725529|Secondary|Percentage of Participants With Sustained Virologic Response at Week 72 (SVRW72)||Week 72|ITT population included all the randomized participants who took at least 1 dose of study drug. ‘N’ (number of participants analyzed) signifies those participants who were analyzed for this measure.|||percentage of participants|||Number
2643731|NCT01725529|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Study Drug Treatment (SVR24)|Participants considered to have achieved SVR24 if both conditions are met: 1). the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ;25 IU/mL) undetectable at end of treatment and, 2). the HCV RNA is < LLOQ detectable or undetectable at 24 weeks after the planned end of study drug treatment.|24 weeks after the end of treatment (EOT: Week 24 or 48)|ITT population included all the randomized participants who took at least 1 dose of study drug.|||percentage of participants|||Number
2643732|NCT01725529|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12)|Participants considered to have achieved SVR12 if both conditions are met: 1). the hepatitis C virus ribonucleic acid (HCV RNA) is less than (<) lower limit of quantification (LLOQ; 25 international unit per milliliter [IU/mL]) undetectable at end of treatment and, 2). the HCV RNA is < LLOQ detectable or undetectable at 12 weeks after the planned end of study drug treatment.|12 weeks after the end of treatment (EOT: Week 24 or 48)|Intent-to-treat (ITT) population included all the randomized participants who took at least 1 dose of study drug.|||Percentage of participants|||Number
2643733|NCT01725451|Primary|Pharmacokinetics: Maximum Drug Concentration (Cmax) of Testosterone|The Cmax from time 0 to 72 hours postdose, based on baseline-corrected concentrations. Baseline-corrected Cmax was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.|Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug|All randomized participants who received at least 1 dose of testosterone 2% solution for the specified treatment regimen.|||nanograms per deciliter (ng/dL)||Geometric Coefficient of Variation|Geometric Mean
2643734|NCT01725451|Primary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of Testosterone|The AUC from time 0 to 72 hours [AUC (0-72)] postdose, based on baseline-corrected concentrations. Baseline-corrected AUC (0-72) was calculated using the measured concentrations of total testosterone minus mean baseline testosterone concentration. Baseline testosterone concentration was the arithmetic mean of 3 predose concentrations.|Pre-dose [60 to 45 minutes (min), 30 to 15 min, 5 minutes prior to each dose], 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, and 72 hours after administration of study drug|All randomized participants who received at least 1 dose of testosterone 2% solution and had evaluable 72-hour testosterone concentrations.|||nanograms* hours per deciliter (ng*h/dL)||Geometric Coefficient of Variation|Geometric Mean
2643735|NCT01725386|Secondary|Percentage of Participants With Adverse Events||Up to approximately 4 years|Safety analysis population (participants who received at least one dose of study medication and had at least one post-baseline safety assessment).|||percentage of participants|||Number
2643736|NCT01725386|Secondary|Mean Survival Time||Up to approximately 4 years|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).|||Months||95% Confidence Interval|Mean
2643737|NCT01725386|Secondary|Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline|To document the metastatic breast cancer participant profile, the percentage of participants with histopathology grade diagnosis of moderately differentiated, well differentiated, poorly differentiated/undifferentiated as assessed at baseline was summarized.|Day 1|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).|||percentage of participants|||Number
2643738|NCT01725386|Secondary|Percentage of Participants With Relevant Medical History Assessed at Baseline|To document the metastatic breast cancer participant profile, the percentage of participants with relevant medical history as assessed at baseline was summarized.|Day 1|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).|||percentage of participants|||Number
2644057|NCT01721603|Secondary|Median Progression-free Survival|Determine the median progression-free survival of BRAFV600E melanoma brain metastasis patients treated with SRS, trametinib and dabrafenib.|From surgery up to 12 months|Study was terminated due to low accrual. Secondary outcome measure was not accessed.||||||
2643739|NCT01725386|Primary|Percentage of Participants Receiving Concomitant Medications During the Study|Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported.|Up to approximately 4 years|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).|||percentage of participants|||Number
2643740|NCT01725386|Primary|Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy|To document use of Capecitabine regimen in the management of participants with metastatic breast cancer, the choice of Capecitabine monotherapy versus combination therapy was summarized according to whether the selection was for the participant's first, second, or third line of treatment.|Up to approximately 4 years|Participants eligible for analysis (received at least one dose of study medication and for whom data for at least one follow-up variable were available).|||percentage of participants|||Number
2643741|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
2643742|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
2643743|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
2643744|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
2643745|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
2643746|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
2644216|NCT01721096|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).|8 months post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2643747|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
2643748|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide).|Weeks 4, 8|SAF participants with available data at each time point; LOCF imputation method was used for end of Treatment Period I.|||participants|||Number
2643749|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
2643750|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
2643751|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
2643752|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||particpants|||Number
2643761|NCT01725308|Secondary|Number of Participants With Adverse Events (Combined Treatment Period I and II)|An AE is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs reported are AEs that occurred after the start of the FK949E treatment for all groups.|Up to 54 weeks (Placebo / FK949E, from week 12 to week 52, for FK949E 150 mg / FK949E & FK949E 300 mg / FK949E groups, from week 0 to week 52)|SAF for combined Treatment Periods I and II, which included participants who were treated with FK949E at least one time.|||Participants|||Count of Participants
2643753|NCT01725308|Secondary|Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||Participants|||Count of Participants
2643754|NCT01725308|Secondary|Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I)|The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked.|Weeks 4, 8|SAF participants with available data at each time point; LOCF imputation method was used for end of Treatment Period I.|||participants|||Number
2643755|NCT01725308|Secondary|Change From Baseline in YMRS (Combined Treatment Period I and II)|"The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates Absent or Normal. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12."|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used for value at end of combined treatment period.|||units on a scale||Standard Deviation|Mean
2643756|NCT01725308|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I)|"The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates Absent or Normal."|Baseline and Weeks 1, 2, 3, 4, 6, 8|SAF participants with available data at each time point; LOCF imputation method for end of Treatment Period I was used.|||units on a scale||Standard Deviation|Mean
2643757|NCT01725308|Secondary|Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II)|"The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12."|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 52|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.|||umits on a scale||Standard Deviation|Mean
2643758|NCT01725308|Secondary|Change From Baseline in DIEPSS: Parkinsonism (Treatment Period I)|"The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe)."|Baseline and Weeks 4, 8|SAF participants with available data at each time point; LOCF imputation method for end of Treatment Period I was used.|||units on a scale||Standard Deviation|Mean
2643759|NCT01725308|Secondary|Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II)|"The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12."|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 52|SAF (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.|||units on a scale||Standard Deviation|Mean
2643760|NCT01725308|Secondary|Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score (Treatment Period I)|"The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity."|Baseline and Weeks 4, 8|SAF participants with available data at each time point; LOCF was used for end of Treatment Period I.|||units on a scale||Standard Deviation|Mean
2643762|NCT01725308|Secondary|Number of Participants With Adverse Events (Treatment Period I)|An adverse event (AE) is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important.|Up to 8 weeks|Safety Analysis Set (SAF), which included participants who received at least one dose of study drug for Treatment Period I.|||participants|||Number
2643763|NCT01725308|Secondary|CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II)|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1)|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.|||units on a scale||Standard Deviation|Mean
2643764|NCT01725308|Secondary|CGI-BP-C: Overall Bipolar Illness (Treatment Period I)|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||units on a scale||Standard Deviation|Mean
2643765|NCT01725308|Secondary|CGI-BP-C: Depression (Combined Treatment Period I and II)|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1)|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputtion was used at end of combined treatment period.|||units on a scale||Standard Deviation|Mean
2643766|NCT01725308|Secondary|CGI-BP-C: Depression (Treatment Period I)|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||units on a scale||Standard Deviation|Mean
2643767|NCT01725308|Secondary|CGI-BP-C: Mania (Combined Treatment Period I and II)|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1)|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.|||units on a scale||Standard Deviation|Mean
2643768|NCT01725308|Secondary|Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I)|The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score.|Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||units on a scale||Standard Deviation|Mean
2643769|NCT01725308|Secondary|Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II)|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.|||units on a scale||Standard Deviation|Mean
2643770|NCT01725308|Secondary|Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I)|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician with the scale from 1 (not ill) to 7 (very severely ill).|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||units on a scale||Standard Deviation|Mean
2643771|NCT01725308|Secondary|Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II)|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation was used at end of combined treatment period.|||units on a sale||Standard Deviation|Mean
2643772|NCT01725308|Secondary|Change From Baseline in CGI-BP-S: Depression (Treatment Period I)|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician with the scale from 1 (not ill) to 7 (very severely ill).|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||units on a scale||Standard Deviation|Mean
2643793|NCT01725217|Secondary|Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination|Safety was assessed as the percentages of subjects aged ≥6 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination, overall and by age group|Within days 1 through 7 postvaccination|Analysis was done on safety dataset|||Percentage of Subjects|||Number
2646697|NCT01702246|Secondary|Change in Plasma High Sensitivity C-reactive Protein|Mean difference in plasma high sensitivity C-reactive protein level, before and after treatment with simvastatin|Baseline and 3 months||||mg/mL||Standard Deviation|Mean
2643773|NCT01725308|Secondary|Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II)|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.|||units on a scale||Standard Deviation|Mean
2643774|NCT01725308|Secondary|Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I)|The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill).|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||units on a scale||Standard Deviation|Mean
2643775|NCT01725308|Secondary|Number of Participants With HAM-D17 Response (Combined Treatment Period I and II)|A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 44, 52|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.|||Participants|||Count of Participants
2643776|NCT01725308|Secondary|Number of Participants With HAM-D17 Response (Treatment Period I)|A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state.|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||Participants|||Count of Participants
2643777|NCT01725308|Secondary|Change From Baseline in HAM-D17 (Combined Treatment Period I and II)|The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 40, 44, 52|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.|||units on a scale||Standard Deviation|Mean
2643778|NCT01725308|Secondary|Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I)|The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state.|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||units on a scale||Standard Deviation|Mean
2643779|NCT01725308|Secondary|Number of Participants With MADRS Remission (Combined Treatment Period I and II)|MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10.|Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.|||Participants|||Count of Participants
2643780|NCT01725308|Secondary|Number of Participants With MADRS Remission (Treatment Period I)|MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.|Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||Participants|||Count of Participants
2643781|NCT01725308|Secondary|Number of Participants With MADRS Response (Combined Treatment Period I and II)|A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52|FAS (for combined Treatment Period I and II) participants with available data at each time point; LOCF imputation method was used at end of combined treatment period.|||Participants|||Count of Participants
2643782|NCT01725308|Secondary|Number of Participants With MADRS Response (Treatment Period I)|A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation method was used for all time points.|||Participants|||Count of Participants
2643980|NCT01722331|Primary|Number of Participants Discontinuing Study Drug Due to a Drug-Related AE (Extension Study)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 192 weeks||2020-05-31|05/2020||||
2643783|NCT01725308|Secondary|Change From Baseline in MADRS Total Score (Combined Treatment Period I and II)|The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12.|Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52|FAS for combined Treatment Period I and II, which included participants who received at least one dose of FK949E and had measurements taken for at least one efficacy endpoint after the start of FK949E treatment, and with available data at each time point. LOCF imputation method was used at end of combined treatment period.|||units on a scale||Standard Deviation|Mean
2643784|NCT01725308|Secondary|Change From Baseline in MADRS Total Score (Treatment Period I)|The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.|Baseline and Weeks 1, 2, 3, 4, 6, 8|FAS; LOCF imputation was used for all time points.|||units on a scale||Standard Deviation|Mean
2643785|NCT01725308|Primary|Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms.|Baseline and Week 8|FAS; Last observation carried forward (LOCF) imputation was used for end of Treatment Period I.|||units on a scale||Standard Deviation|Mean
2643786|NCT01725282|Secondary|Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests|An AE is defined as any untoward medical occurrence in a patient administered a study drug, and which does not necessarily have a causal relationship with this treatment. Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug.|Up to 8 weeks||||participants|||Number
2643787|NCT01725282|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index (PSQI)|"The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction, each on a scale from 0 (best) to 3 (worst). The sum of scores for these seven components yields one global score, ranging from 0 to 21, with higher scores indicative of poor sleep quality."|Baseline and Week 6|Full analysis set with available PSQI data; LOCF was used.|||units on a scale||Standard Deviation|Mean
2643788|NCT01725282|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)|"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are:~Limitation in physical activities because of health problems.~Limitations in usual role activities because of physical health problems.~Bodily pain.~Limitations in social activities because of physical or emotional problems.~General mental health (psychological distress and well-being).~Limitations in usual role activities because of emotional problems.~Vitality (energy and fatigue).~General health perception.~Each scale ranges from 0 to 100, with 0 indicating the least favorable status and 100 being the most favorable health status."|Baseline and Week 6|Full analysis set with available SF-36 data; LOCF was used.|||units on a scale||Standard Deviation|Mean
2643789|NCT01725282|Secondary|Percentage of Participants With Improvement in Clinical Global Impressions-Improvement (CGI-I)|"The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, markedly improved; 2, moderately improved; 3, minimally improved; 4, no change; 5, minimally worsened; 6, moderately worsened; or 7, markedly worsened.~Improvement is defined as a score of 1 or 2."|Baseline and Week 6|Full analysis set; Last observation carried forward (LOCF) imputation was used.|||percentage of participants|||Number
2643790|NCT01725282|Secondary|Change From Baseline in Hamilton Rating Score for Depression (HAM-D17)|The 17-item Hamilton Depression Scale (HAM-D17) is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 52 where a higher score indicates a greater depressive state.|Baseline and Week 6|Full analysis set; Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2643791|NCT01725282|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement.|Baseline and Week 6|Full Analysis Set: Participants who met the following requirements: major depressive disorder confirmed at registration; at least one dose of the study drug for the treatment period was administered; and at least one efficacy variable was assessed after the start of treatment. Last observation carried forward (LOCF) imputation was used.|||units on a scale||Standard Error|Least Squares Mean
2643792|NCT01725217|Secondary|Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination|Safety was assessed in terms of percentages of subjects who reported all the adverse events (AEs) occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29, after MenACWY-CRM vaccination, overall and by age group|AEs occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29|Analysis was done on safety dataset|||percentage of subjects|||Number
2646874|NCT01700439|Secondary|Average Amount of Time Subject Spent on Cardiopulmonary Bypass|Surgical and hospitalization factors - Cardiopulmonary bypass time|Day of procedure|Data is not available for two subjects.|||Minutes||Standard Deviation|Mean
2643794|NCT01725217|Secondary|Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination|Safety was assessed as the percentages of subjects aged 2 through 5 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination|Within days 1 through 7 postvaccination|Analysis was done on safety dataset, i.e. all subjects in the exposed population who provided any post-baseline safety data|||Percentage of subjects|||Number
2643795|NCT01725217|Secondary|Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination|Immunogenicity was measured as the percentages of subjects with hSBA titer ≥1:8, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group|Days 1 and 29|Analysis was done on FAS dataset|||Percentage of Subjects||95% Confidence Interval|Number
2643796|NCT01725217|Secondary|Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination|Immunogenicity was measured as hSBA GMTs, against N meningitidis serogroups A, C, W and Y, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group|Days 1 and 29|Analysis was done on FAS dataset|||human serum bactericidal assay titer||95% Confidence Interval|Geometric Mean
2643797|NCT01725217|Secondary|Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group|Immunogenicity was measured as the percentages of subjects stratified by age group with hSBA response, directed against N meningitidis serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM|Day 29|Analysis was done on FAS dataset|||Percentage of subjects||95% Confidence Interval|Number
2643798|NCT01725217|Primary|Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination|"Immunogenicity was measured as the percentages of overall subjects with hSBA (human serum bactericidal assay) seroresponse, directed against Neisseria meningitidis (N meningitidis) serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM (day 29).~The seroresponse is defined as the percentages of subjects achieving hSBA ≥1:8 postvaccination with a prevaccination hSBA <1:4 and the percentages of subjects achieving at least four-fold increases in postvaccination hSBA from day 1 in subjects with a baseline hSBA ≥1:4"|Day 29|Analysis was done on Full Analysis Set (FAS), i.e., all subjects in the exposed population who provided one evaluable serum sample whose assay result is available for at least one serogroup at baseline and at day 29|||Percentage of subjects||95% Confidence Interval|Number
2643799|NCT01725126|Secondary|Tmax of Metformin During the Double-blind Treatment Period of Part C|Blood samples were planned to be collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose. The time at which Cmax was observed was planned to be determined directly from the raw concentration-time data. The data for PK parameters of metformin during Part C was not collected due to variations in formulation and regimen.|Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose|Metformin PK Population in Part C. The data for PK parameters of metformin during Part C was not collected due to variations in formulation and regimen.||||||
2643800|NCT01725126|Secondary|Cmax of Metformin During the Double-blind Treatment Period of Part C|Blood samples were planned to be collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose. The first occurrence of the Cmax was planned to be determined directly from the raw concentration-time data. The data for PK parameters of metformin during Part C was not collected due to variations in formulation and regimen.|Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose|Metformin PK Population in Part C. The data for PK parameters of metformin during Part C was not collected due to variations in formulation and regimen.||||||
2643801|NCT01725126|Secondary|AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) of Metformin During the Double-blind Treatment Period of Part C|Blood samples were planned to be collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose. The AUC 0-t was planned to be determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. The data for PK parameters of metformin during Part C was not collected due to variations in formulation and regimen.|Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose|Metformin PK Population in Part C comprised of all participants in the All Subjects Population for whom a PK sample was obtained and analyzed for metformin. The data for PK parameters of metformin during Part C was not collected due to variations in formulation and regimen.||||||
2643802|NCT01725126|Secondary|Tmax of Metformin During the Double-blind Treatment Period of Part A|Blood samples were collected on Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8 and 10 (pre-dinner) hours post-dose. The time at which Cmax was observed was determined directly from the raw concentration-time data.|Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose|Metformin PK Population in Part A. Only those participants available at the specified time points were analyzed.|||Hours||Full Range|Median
2643803|NCT01725126|Secondary|Cmax of Metformin During the Double-blind Treatment Period of Part A|Blood samples were collected on Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8 and 10 (pre-dinner) hours post-dose. The first occurrence of the Cmax was determined directly from the raw concentration-time data.|Day 1 and Day 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose|Metformin PK Population in Part A. Only those participants available at specified time points were analyzed. The results from the descriptive summary used the PK Population. However, the results of the statistical analysis compared Day 42 to Day 1 PK only in the GSK2890457 group who were in the PK Population.|||Nanograms/mL||Geometric Coefficient of Variation|Geometric Mean
2643838|NCT01725126|Primary|Change From Baseline in Hematology Parameters of RBC Count and Reticulocytes During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||TI/L||Standard Deviation|Mean
2643804|NCT01725126|Secondary|AUC of Metformin From Time 0 to 10 Hours Post-dose (AUC [0-10 Hour]) During the Double-blind Treatment Period of Part A|Blood samples were collected on Day 1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8 and 10 (pre-dinner) hours post-dose. The AUC (0-10 hour) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. The analysis population included Metformin PK Population in Part A comprising of all participants in All Subjects Population for whom a PK sample was obtained and analyzed for metformin.|Day 1 and Day 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8 and 10 hours post-dose|Metformin PK Population in Part A. Only those participants available at specified time points were analyzed. The results from the descriptive summary used the PK Population. However, the results of the statistical analysis compared Day 42 to Day 1 PK only in the GSK2890457 group who were in the PK Population.|||Hour*nanograms/mL||Geometric Coefficient of Variation|Geometric Mean
2643805|NCT01725126|Secondary|Time of Occurrence of Cmax (Tmax) of Liraglutide During the Double-blind Treatment Period of Part B|Blood samples were collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose. The time at which Cmax was observed was determined directly from the raw concentration-time data.|Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose|Liraglutide PK Population in Part B. Only those participants available at the specified time points were analyzed.|||Hours||Full Range|Median
2643806|NCT01725126|Secondary|Maximum Observed Concentration (Cmax) of Liraglutide During the Double-blind Treatment Period of Part B|Blood samples were collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post-dose. The first occurrence of the Cmax was determined directly from the raw concentration-time data.|Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose|Liraglutide PK Population in Part B. Only those participants available at the specified time points were analyzed. Results from descriptive summary used Liraglutide PK Population. However, results of statistical analysis compared Day 42 to Day -1 PK in GSK2890457+Liraglutide group who were in the Liraglutide PK Population.|||Nanograms/mL||Geometric Coefficient of Variation|Geometric Mean
2643807|NCT01725126|Secondary|Area Under Plasma Concentration From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) of Liraglutide During the Double-blind Treatment Period of Part B|Blood samples were collected on Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4 (pre-lunch), 5.5, 6, 8, 10 (pre-dinner), 11.5, 12, 14 and 24 hours post dose. The AUC (0-t) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. The analysis population included Liraglutide Pharmacokinetic (PK) Population in Part B comprising of all participants in All Subjects Population for whom a PK sample was obtained and analyzed for Liraglutide.|Day -1 and 42 at pre-dose (0 hour), 15 minutes, 30 minutes, 1, 1.5, 2, 4, 5.5, 6, 8, 10, 11.5, 12, 14 and 24 hours post-dose|Liraglutide Pharmacokinetic (PK) Population in Part B. Only those participants available at specified time points were analyzed. Results from descriptive summary used Liraglutide PK Population. However, results of statistical analysis compared Day 42 to Day -1 PK in GSK2890457+Liraglutide group who were in the Liraglutide PK Population.|||Hour*nanograms/mL||Geometric Coefficient of Variation|Geometric Mean
2643808|NCT01725126|Primary|Change From Baseline in Fasting Plasma Glucose (Safety Laboratory) Values During the Double-blind Treatment Period of Part B and C|The assessments were done at Day -1, Day 7, Day 14, Day 28, Day 42 and Follow-up Visit. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline (Day 7, 14, 28, 42 and Follow-up visit) values.|Baseline (Day -1) up to Follow-up (Day 56)|PD Population. Only those participants available at the specified time points were analyzed.|||mmol/L||Standard Deviation|Mean
2643809|NCT01725126|Primary|Change From Baseline in Matsuda Index During the Double Blind-treatment Period of Part B and C|The matsuda index was calculated from the Day -1 and Day 42 glucose and insulin results as 10,000 divided by (fasting plasma glucose x fasting plasma insulin x mean glucose at 0-2 hour post-dose x mean insulin at 0-2 hour post dose)^1/2, where glucose was measured in mmol/L and insulin in pmol/L. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data for Part C of the study was not collected because fasting glucose and insulin were not available at the specified time points.|Baseline (Day -1) and Day 42|PD Population. Only those participants available at the specified time points were analyzed. Data for Part C of the study was not collected because fasting glucose and insulin were not available at the specified time points.|||Deciliter*mL/mg*mU||Standard Deviation|Mean
2643810|NCT01725126|Primary|Change From Baseline in Homeostasis Model of Assessment-Insulin Resistance (HOMA-IR]) During the Double-blind Treatment Period of Part B and C|HOMA-IR was calculated from the Day -1 and Day 42 fasting glucose and insulin values using dataset generated from the HOMA-2 model. It contained the estimates for HOMA-% insulin sensitivity (S) for pairs of fasting glucose and fasting insulin values. Study data was merged with the HOMA dataset by glucose and insulin. HOMA-IR was calculated as 100/HOMA-%S. HOMA-IR was not determined for any values outside the ranges of plasma glucose 3.5 to 25.0 mmol/L (63 - 450 mg/dL) and plasma insulin 20 to 400 pmol/L. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data for Part C of the study was not collected because fasting glucose and insulin were not available at the specified time points.|Baseline (Day -1) and Day 42|PD Population. Only those participants available at the specified time points were analyzed. Data for Part C of the study was not collected because fasting glucose and insulin were not available at the specified time points.|||mU*mmol/L^2||Standard Deviation|Mean
2643811|NCT01725126|Primary|Change From Baseline in Glycated Hemoglobin (HbA1c) During the Double-blind Treatment Period of Part B and C|Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Adjusted mean is reported as LS mean.|Baseline (Day -1) and Day 42|PD Population. Only those participants available at the specified time points were analyzed.|||Percent of TL hemoglobin||Standard Error|Least Squares Mean
2648081|NCT01688141|Secondary|Blood Pressure Control|Observation of blood pressure control over the study period via blood pressure targets|Baseline and 3.5 years|Denominator change due to loss to follow-up and death.|||Participants|||Count of Participants
2643812|NCT01725126|Primary|Change From Baseline in Fasting Insulin and Weighted Mean Insulin AUC (0-4 Hour) and AUC (0-24 Hour) During the Double-blind Treatment Period of Part B and C|Two fasting samples 5 minutes apart were taken for insulin. Baseline insulin level was the average of the 2 fasting samples. For insulin weighted mean AUC (0-4 hour) and weighted mean AUC (0-24 hour) was calculated for Baseline (Day -1) and end of treatment (Day 42). AUC was calculated using the linear trapezoid method that is the sum of the areas between each chronological pair of assessments at the time points (at Day -1 and Day 42). The weighted mean was then calculated by dividing the AUC by the length of the time interval over which it was calculated. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data is reported for weighted mean insulin AUC (0-4 hour) post-breakfast and AUC (0-24 hour) post-breakfast.|Baseline (Day -1) and Day 42|PD Population. Only those participants available at the specified time points were analyzed.|||pmol/L||Standard Deviation|Mean
2643813|NCT01725126|Primary|Change From Baseline in Fasting Glucose During the Double-blind Treatment Period of Part B and C|Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Adjusted mean is reported as LS mean.|Baseline (Day -1) and Day 42 of Part B and C|PD Population. Only those participants available at the specified time points were analyzed.|||mmol/L||Standard Error|Least Squares Mean
2643814|NCT01725126|Primary|Change From Baseline in Weighted Mean Glucose Area Under the Curves From Time 0 to 24 Hours (AUC [0-24 Hours]) During the Double-blind Treatment Period of Part B and C|AUC was calculated using the linear trapezoid method that is the sum of the areas between each chronological pair of assessments at the time points (at Day -1 and Day 42). The weighted mean was then calculated by dividing the AUC by the length of the time interval over which it was calculated. Baseline was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline (Day -1) values from the post-Baseline value (Day 42). Data is reported for weighted mean glucose AUC (0-4 hour) post-breakfast and AUC (0-24 hour) post-breakfast. Adjusted mean is reported as least square (LS) mean.|Baseline (Day -1) and Day 42|PD Population. Only those participants available at the specified time points were analyzed.|||mmol/L||Standard Error|Least Squares Mean
2643815|NCT01725126|Primary|Percent Change From Baseline in In-clinic Body Weight During the Double-blind Treatment Period of Part B and C|During the assessment of body weight in the unit, the participant wore lightweight indoor clothing and removed shoes. The assessments were done pre-dose at Day -1, Day 1, Day 7, Day 14, Day 28, Day 42 and Day 43. Baseline value was defined as the average of Day -1 and Day 1 values. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. Percent change was calculated by multiplying the change from Baseline value with 100. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. Day 42 value was the average of Day 42 and Day 43 values.|Baseline (Day -1 and Day 1) up to Day 42|PD Population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Deviation|Mean
2643816|NCT01725126|Primary|Change From Baseline in In-clinic Body Weight During the Double-blind Treatment Period of Part B and C|During the assessment of body weight in the unit, the participant wore lightweight indoor clothing and removed shoes. The assessments were done pre-dose at Day -1, Day 1, Day 7, Day 14, Day 28, Day 42 and Day 43. Baseline value was defined as the average of Day -1 and Day 1 values. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing. Day 42 value was the average of Day 42 and Day 43 values.|Baseline (Day -1 and Day 1) up to Day 42|Pharmacodynamic (PD) Population comprised of all participants in the All Subjects Population who had Baseline and at least one post-Baseline assessment of the endpoint. Only those participants available at the specified time points were analyzed.|||Kilograms (kg)||Standard Deviation|Mean
2643817|NCT01725126|Primary|Change From Baseline in the Overall GSRS Score During the Double-blind Treatment Period of Part B and C|The impact of GI symptoms on health-related quality of life was assessed using the GSRS. The GSRS is a 15-item related to abdominal pain, reflux, indigestion, diarrhea and constipation syndromes, self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Overall GSRS was the mean of items 1 to 15. Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to GI symptoms and higher scores indicating a lower quality of life with respect to GI symptoms. Baseline was defined as the assessment done on Day -2. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, 14, 28 and 41) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -2) up to Day 41|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Deviation|Mean
2643818|NCT01725126|Primary|Change From Baseline in the Overall Gastrointestinal (GI) Symptoms Rating Scale (GSRS) Score During the Double-blind Treatment Period of Part A|The impact of GI symptoms on health-related quality of life was assessed using the GSRS. The GSRS is a 15-item related to abdominal pain, reflux, indigestion, diarrhea and constipation syndromes, self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Overall GSRS was the mean of items 1 to 15. Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to GI symptoms and higher scores indicating a lower quality of life with respect to GI symptoms. Baseline was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, 14 and 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Deviation|Mean
2643915|NCT01723826|Primary|Percentage of Participants With Human Anti-Therapeutic Antibody (ATA) Formation|ATA is a measurement to explore the potential relationship of immunogenicity response with pharmacokinetics, safety and efficacy. Percentage of participants at post-baseline with positive results for ATA against crenezumab are reported.|Pre-dose (Day-14), predose at Week 25, 49, 97, Follow-up Week 8 (Week 153) and 12 (Week 157)|Safety Analysis population included all participants who received at least one dose of study drug.|||percentage of participants|||Number
2643819|NCT01725126|Primary|Change From Baseline in ECG Intervals During Part B and C|Single 12-lead ECGs was obtained after participants rested in a supine position for at least 10 minutes using an ECG machine that automatically calculated the HR and measured PR, QRS, QT, QTcB, QTcF and RR intervals. The assessments were done at Day -1 (pre-dose, triplicate), Day 42 (pre-dose) and Follow-up Visit. Baseline value was defined as the average of the triplicate pre-dose assessments done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42 and Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Follow-up (Day 56)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Milliseconds||Standard Deviation|Mean
2643820|NCT01725126|Primary|Change From Baseline in Electrocardiogram (ECG) Intervals During Part A|Single 12-lead ECGs was obtained after participants rested in a supine position for at least 10 minutes using an ECG machine that automatically calculated the HR and measured PR, QRS, QT, QT duration corrected for HR by Fridericia's formula (QTcF) and QT duration corrected for HR by Bazett's formula (QTcB intervals. The assessments were done at Day 1 (pre-dose, triplicate), Day 42 (pre-dose) and Follow-up Visit. Baseline value was defined as the average of the triplicate pre-dose assessments done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42 and Follow-up) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Follow-up (Day 56)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Milliseconds||Standard Deviation|Mean
2643821|NCT01725126|Primary|Change From Baseline in Vital Sign Parameter of HR During the Double-blind Treatment Period of Part B and C|Vital sign assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2643822|NCT01725126|Primary|Change From Baseline in Vital Sign Parameter of Heart Rate (HR) During the Double-blind Treatment Period of Part A|Vital sign assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2643823|NCT01725126|Primary|Change From Baseline in Vital Sign Parameter of SBP and DBP During the Double-blind Treatment Period of Part B and C|Vital sign assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||mmHg||Standard Deviation|Mean
2643824|NCT01725126|Primary|Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During the Double-blind Treatment Period of Part A|Vital sign assessments were performed after resting in a supine or semi-supine position for at least 10 minutes. The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2643825|NCT01725126|Primary|Mean pH Values of Urine During the Double-blind Treatment Period of Part B and C|Urinalysis parameter included urine pH. pH was calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. The assessments were done pre-dose on Day -1, Day 7, Day 14, Day 28 and Day 42.|Up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||pH||Standard Deviation|Mean
2643826|NCT01725126|Primary|Mean pH Values of Urine During the Double-blind Treatment Period of Part A|Urinalysis parameter included urine pH. pH was calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. The assessments were done pre-dose on Day 1, Day 7, Day 14, Day 28 and Day 42.|up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||pH||Standard Deviation|Mean
2643827|NCT01725126|Primary|Mean Specific Gravity Values of Urine During the Double-blind Treatment Period of Part B and C|Urinary specific gravity is a measure of the concentration of solutes in urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42.|Up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2643828|NCT01725126|Primary|Mean Specific Gravity Values of Urine During the Double-blind Treatment Period of Part A|Urinary specific gravity is a measure of the concentration of solutes in urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. The assessments were done pre-dose at Da y 1, Day 7, Day 14, Day 28 and Day 42.|Up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2643829|NCT01725126|Primary|Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. The participants were categorized as few, many, moderate, trace, +1, 2+, 3+, 0-3, 10-20, 0-5, 6-10, 20-40, 40-60. Protein and ketone ranged from trace to 1+, trace indicated lowest and 1+ indicated highest concentration. Bacteria and uric acid crystals ranged from few to moderate, few indicated lowest and moderate indicated highest concentration. Trace was the highest concentration of occult blood. Epithelial cells ranged from 0-5 to >10, 0-5 indicated lowest and >10 indicated highest concentration. Glucose ranged from trace to 3+, trace indicated lowest and 3+ indicated highest concentration. 0-1 was highest concentration for hyaline casts. RBC and WBC ranged from 0-3 to 40-60, 0-3 indicated lowest and 20-40 indicated highest concentration. Highest concentration indicated worse outcome.|Up to Day 42|All Subjects Population.|||Participants|||Count of Participants
2643830|NCT01725126|Primary|Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part B|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Only those parameters for which at least one value of abnormal urinalysis result was reported are summarized. The participants were categorized as few, trace, +1, 2+, 3+, 0-3, 10-20, 0-5, 6-10, and 20-40. Few was the highest concentration of bacteria. Occult blood ranged from trace to 1+, trace indicated lowest and 1+ indicated highest concentration. Epithelial cell ranged from 0-5 to 10-20, 0-5 indicated lowest and 10-20 indicated highest concentration. Glucose ranged from trace to 3+, trace indicated lowest and 3+ indicated highest concentration. 0-5 was highest concentration for hyaline casts. Ketone ranged from trace to 1+, trace indicated lowest and 1+ indicated highest concentration. RBC and WBC ranged from 0-3 to 20-40, 0-3 indicated lowest and 20-40 indicated highest concentration. Highest concentration indicated worse outcome.|Up to Day 42|All Subjects Population.|||Participants|||Count of Participants
2643831|NCT01725126|Primary|Number of Participants With Abnormal Urinalyisis Dipstick and Microscopic Results During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Only those parameters for which at least one value of abnormal urinalysis result was reported are summarized. The participants were categorized as rare, trace, +1, 2+, RBC's and WBC's as <1, 1, 2, 3 and 4. Protein concentration ranged from trace to 1+, where trace indicated lowest concentration and 1+ indicated highest concentration. Trace was the highest concentration for occult blood. Bacteria concentration ranged from rare to moderate, where rare indicated lowest concentration and moderate indicated highest concentration. Ketones ranged from trace to 1+, where trace indicated lowest concentration and 1+ indicated highest concentration. RBC and WBC ranged from <1 to 4, where <1 indicated lowest concentration and 4 indicated highest concentration. Highest concentration indicated worse outcome.|Up to Day 42|All Subjects Population.|||Participants|||Count of Participants
2643832|NCT01725126|Primary|Change From Baseline in Hematology Parameter of MCV During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Femtoliters||Standard Deviation|Mean
2643833|NCT01725126|Primary|Change From Baseline in Hematology Parameter of Mean Corpuscle Volume (MCV) During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Femtoliters||Standard Deviation|Mean
2643834|NCT01725126|Primary|Change From Baseline in Hematology Parameter of MCH During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Picograms||Standard Deviation|Mean
2643835|NCT01725126|Primary|Change From Baseline in Hematology Parameter of Mean Corpuscle Hemoglobin (MCH) During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Picograms||Standard Deviation|Mean
2643836|NCT01725126|Primary|Change From Baseline in Hematology Parameter of Hematocrit During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2643837|NCT01725126|Primary|Change From Baseline in Hematology Parameter of Hematocrit During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2643839|NCT01725126|Primary|Change From Baseline in Hematology Parameters of Red Blood Cell (RBC) Count and Reticulocytes During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Trillion cells (TI)/L||Standard Deviation|Mean
2643840|NCT01725126|Primary|Change From Baseline in Hematology Parameters of Hemoglobin and MCHC During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||g/L||Standard Deviation|Mean
2643841|NCT01725126|Primary|Change From Baseline in Hematology Parameters of Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||g/L||Standard Deviation|Mean
2643842|NCT01725126|Primary|Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||GI/L||Standard Deviation|Mean
2643843|NCT01725126|Primary|Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell (WBC) Count During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Giga cells (GI)/L||Standard Deviation|Mean
2643844|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Thyroid Stimulating Hormone During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7 and Day 42. Baseline value was defined as the assessment done Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Milliunits (mu/L)||Standard Deviation|Mean
2643845|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Total Thyroxine and Total T3 During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1 and Day 42. Baseline value was defined as the assessment done Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42) value. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) and Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Nanomoles (nmol)/L||Standard Deviation|Mean
2643846|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameter of Triiodothyronine (T3) Uptake During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1 and Day 42. Baseline value was defined as the assessment done Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42) value. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) and Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2643847|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Amylase and Lipase the Double-blind Treatment Period of Part B of Study|The assessments were done pre-dose at Day -1 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 42) value. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) and Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Units (U)/L||Standard Deviation|Mean
2643848|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Insulin During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||pmol/L||Standard Deviation|Mean
2644217|NCT01721096|Secondary|Number of Participants With All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|4 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2643849|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Insulin During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Picomoles (pmol)/L||Standard Deviation|Mean
2643850|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Albumin and Total Protein During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||g/L||Standard Deviation|Mean
2643851|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Albumin and Total Protein During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||g/L||Standard Deviation|Mean
2643852|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||umol/L||Standard Deviation|Mean
2643853|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid During the Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Micromoles (umol)/L||Standard Deviation|Mean
2643854|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Electrolytes, Glucose Phosphorus Inorganic, BUN and Cholesterol During the Double-blind Treatment Period of Part B and C|The electrolytes include calcium, chloride, carbon dioxide content/bicarbonate, potassium, magnesium and sodium. Assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||mmol/L||Standard Deviation|Mean
2643855|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Electrolytes, Glucose Phosphorus Inorganic and Urea/Blood Urea Nitrogen (BUN) During the Double-blind Treatment Period of Part A|The electrolytes include calcium, chloride, carbon dioxide content/bicarbonate, potassium, magnesium and sodium. Assessments were done pre-dose at on Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Millimoles (mmol)/L||Standard Deviation|Mean
2643856|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of ALP, ALT, AST and GGT During the Double-blind Treatment Period of Part B and C|The assessments were done pre-dose at Day -1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day -1) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||IU/L||Standard Deviation|Mean
2643857|NCT01725126|Primary|Change From Baseline in Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), ALT, Aspartate Aminotransferase (AST) and Gamma Glutamyltransferase (GGT) During Double-blind Treatment Period of Part A|The assessments were done pre-dose at Day 1, Day 7, Day 14, Day 28 and Day 42. Baseline value was defined as the assessment done on Day 1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline (Day 7, Day 14, Day 28 and Day 42) values. If either the Baseline or post-Baseline value was missing, the change from Baseline was set to be missing.|Baseline (Day 1, Randomization) up to Day 42|All Subjects Population. Only those participants available at the specified time points were analyzed.|||International unit per liter (IU/L)||Standard Deviation|Mean
2643905|NCT01724021|Primary|Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 6|Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing cycle 6.|Cycle 6 (Up to 24 weeks)|ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.|||percentage of participants||95% Confidence Interval|Number
2643858|NCT01725126|Primary|Number of Participants With Any Hypoglycemic Events During Part B and Part C|Hypoglycemia is defined as symptoms consistent with hypoglycemia (e.g. dizziness, light-headedness, shakiness) which are confirmed by glucometer measurement of CBG or plasma glucose value of <50 mg/dL for Part A or <70 mg/dL for Parts B and C (when possible, CBG values were confirmed with a laboratory measurement). In situations when no glucose sample could be measured at the time of the event, the investigator, at his or her discretion, characterized an event as 'hypoglycemia' based on reported signs and symptoms alone. Healthy participant also had asymptomatic blood glucose values <70 mg/dL as a physiological response to altered food intake (e.g., fasting).|Up to Follow-up (8 weeks)|All Subjects Population.|||Participants|||Count of Participants
2643859|NCT01725126|Primary|Number of Participants With Any Hypoglycemic Events During Part A|Hypoglycemia is defined as symptoms consistent with hypoglycemia (e.g. dizziness, light-headedness, shakiness) which are confirmed by glucometer measurement of complete blood count (CBG) or plasma glucose value of <50 milligram per deciliter (mg/dL) for Part A or <70 mg/dL for Parts B and C (when possible, CBG values were confirmed with a laboratory measurement). In situations when no glucose sample could be measured at the time of the event, the investigator, at his or her discretion, characterized an event as 'hypoglycemia' based on reported signs and symptoms alone. Healthy participant also had asymptomatic blood glucose values <70 mg/dL as a physiological response to altered food intake (e.g., fasting).|Up to Follow-up (8 weeks)|All Subjects Population.|||Participants|||Count of Participants
2643860|NCT01725126|Primary|Number of Participants With Any AE, SAE or Death During Part B and Part C|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as ALT >=3 x ULN, and total bilirubin >=2 x ULN or international normalized ratio >1.5.|Up to Follow-up (8 weeks)|All Subjects Population.|||Participants|||Count of Participants
2643861|NCT01725126|Primary|Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE) or Death During Part A|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase (ALT) >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5.|Up to Follow-up (8 weeks)|All Subjects Population comprised of all randomized participants who received at least one dose of study medication (placebo or GSK2890457).|||Participants|||Count of Participants
2643862|NCT01724528|Other Pre-specified|Treatment Emergent Signs or Symptoms (TESS)|Incidence, severity, seriousness and treatment-causality of TESS|14 ± 2 days|||||||
2643863|NCT01724528|Secondary|Assessment of Clinical Tumor Lysis Syndrome (CTLS)|Assessment of CTLS, from Day 3 to Day 8. According to Cairo-Bishop definition, CTLS is defined by the presence of LTLS in addition to 1 or more of the following significant clinical complications: renal insufficiency, cardiac arrhythmias, sudden death and seizures. The grade of CTLS is defined by the maximal grade of the clinical manifestation|6 days|ITT; no imputation applied|||% of patients with CTLS occurrence|||Number
2643864|NCT01724528|Secondary|Assessment of Laboratory Tumor Lysis Syndrome (LTLS)|Assessment of LTLS, from Day 3 to Day 8. According to Cairo-Bishop definition LTLS is defined by the presence of 2 or more laboratory abnormalities including: a 25% increase or levels above normal for serum uric acid, potassium, and phosphate or a 25% decrease or levels below normal for calcium.|6 days|ITT; no imputation applied|||% of patients with LTLS occurrence|||Number
2643865|NCT01724528|Secondary|Treatment Responder Rate|Assessment of treatment responder rate, where treatment response is defined as the maintenance of sUA ≤ 7.5 mg/dL from Day 3 to Day 8|6 days|Intention to Treat (ITT; no imputation applied|||% of patients who fail to respond|||Number
2643866|NCT01724528|Primary|Preservation of Renal Function|Change in serum creatinine level from baseline (Day 1) to the evaluation visit (Day 8)|8 days|ITT. Sample size calculation: no change in mean serum creatinine level from baseline to the end of treatment for febuxostat group while allopurinol has a increase of 13%; 340 patients were sufficient to achieve approximately 80% power. Imputation method: LOCF; missing baseline values were not replaced|||change %||Standard Deviation|Mean
2643867|NCT01724528|Primary|Serum Uric Acid (sUA) Level Control|Area under the curve of sUA from baseline (Day 1) to the evaluation visit (Day 8)|8 days|Intention to treat (ITT), defined as all randomized patients. Sample size calculation: at least an absolute reduction of 100 mg x h/dL for the AUCsUA1-8 in favour of febuxostat; 340 patients were sufficient to achieve approximately 80% power. Imputation method: last observation carried forward (LOCF); missing baseline values were not replaced.|||mg x hour/dL||Standard Deviation|Mean
2643868|NCT01724489|Primary|Bone Mineral Density|Change in BMD over 18 months in the GH vs placebo group|baseline and 18 months|"Two subjects from the growth hormone arm were not analyzed due to large amount of weight loss, which has a well-documented effect of decreasing BMD. AP spine bone density in one study subject in the placebo group was excluded because the scan was technically poor.~These data were excluded before the study was unblinded."|||grams/cm^2||Standard Deviation|Mean
2643869|NCT01724359|Secondary|Daytime Drowsiness Evaluation Scale|This self-administered scale rates the daytime drowsiness. Patients will indicate on an 11-point scale how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
2643870|NCT01724359|Secondary|Sleep Evaluation Scale|This self-administered scale rates the quality of sleep. Patients will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
2643871|NCT01724359|Secondary|Health Status as Measured by Self-rated Health Status Survey SF-36|The SF-36 is designed to examine a person's perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 - 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts.|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
2643872|NCT01724359|Secondary|Personal and Social Performance (PSP) Scale|This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
2643873|NCT01724359|Secondary|Clinical Global Impression-Severity (CGIS)|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill patients. Higher scores indicate worsening."|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.|||participants|||Number
2643874|NCT01724359|Secondary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score|The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
2643875|NCT01724359|Secondary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score|The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
2643876|NCT01724359|Secondary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score|The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
2643877|NCT01724359|Primary|Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline, Week 26|All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.|||scores on a scale||Standard Deviation|Mean
2643878|NCT01724216|Primary|Number of Head Images Successfully Collected|Collect head human images and associated technical and clinical information to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequence.|6-months||||Images|Participants||Number
2643879|NCT01724177|Secondary|Kaplan-Meier Estimate for Overall Survival|Overall Survival was defined as the time from the start of study treatment to the death due to any cause. For participants who were still alive at the time of the data cutoff, survival data were censored at the latest available date the participant was known to be alive.|From Day 1 of study treatment to disease progression or death; up to final data cut-off date of 19 May 2017; maximum surivival time was 197.9 weeks|The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide.|||weeks||95% Confidence Interval|Median
2643880|NCT01724177|Secondary|Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response (CRu), Partial Response or Stable Disease (SD) as Assessed by the ESEC|The tumor control rate was measured for those with a response of Complete Remission, + CRu, + PR + Stable Disease (SD) in the EE population based on the best response.|From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks|The EE population with a response (CR, CRu, PR or SD) and consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide|||percentage of participants||95% Confidence Interval|Number
2643881|NCT01724177|Other Pre-specified|Time to Response|Time to Response was defined as the time from the first dose of study treatment to the initial documented response (CR or CRu, or PR)|From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks|Participants with a response of PR or better.|||weeks||Full Range|Median
2643882|NCT01724177|Secondary|Kaplan-Meier Estimate of Duration of Response (DOR) for Responders as Assessed by the ESEC|The response duration in participants with an objective response was measured from the date of the first Complete Response or Complete Response unconfirmed or Partial Response to the first date of Relapsed Disease or Progressive Disease (PD). For participants who did not progress during the study, DOR was censored at the last adequate response assessment not showing evidence of PD.|From day 1 of study treatment to first documented response; up to data cut-off date of 19 May 2017; Maximum study duration was 134.1 Weeks|The EE population who had a documented response and consisted of participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide|||weeks||95% Confidence Interval|Number
2643883|NCT01724177|Secondary|Number of Participants With Treatment Emergent Adverse Events|Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the start of study treatment and within 28 days after the last dose. Severity was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): Grade 1= Mild Grade 2= Moderate Grade 3= Severe Grade 4= Life-threatening and Grade 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.|From the date of the first dose of study drug up to 28 days after the last dose of study drug; up to data cutoff date of 19 May 2017; maximum treatment duration was 130.1 weeks|Safety population was defined as all participants who received at least one dose of lenalidomide. All safety analyses were based on the safety population.|||participants|||Number
2643884|NCT01724177|Secondary|Kaplan-Meier Estimate of Time to Progression (TTP)|Time to progression was calculated as the time from the first dosing of study treatment to the first documented PD and assessed by the ESEC|From day 1 of study treatment to the date of disease progression; up to data cut date of 19 May 2017; maximum study duration was 134.1 weeks|The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide|||weeks||95% Confidence Interval|Median
2643885|NCT01724177|Secondary|Kaplan Meier Estimate of Progression Free Survival (PFS) as Assessed by the ESEC|PFS was defined as the time from the first dose of study treatment to progressive disease (PD) or death due to any cause on study or within 28 days after study discontinuation, whichever occurred earlier.|From day 1 of study treatment to the date of disease progression; up to data cut date of date of 19 May 2017; maximum study duration was 134.1 weeks|The EE population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide|||weeks||95% Confidence Interval|Median
2643886|NCT01724177|Primary|Percentage of Participants Who Achieved a Complete Response, Unconfirmed Complete Response, or Partial Response as Assessed by the Efficacy-Safety Evaluation Committee (ESEC)|"ORR is a Complete Response (CR) + Complete Response unconfirmed (CRu) + Partial Response (PR). A CR requires that target lesions have regressed to normal; nodal non-target lesions have regressed to normal; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are GR 0; peripheral blood is normal; Bone marrow (BM) infiltration is negative and no new lesions. A CRu requires the sum of the product diameters (SPD) of target lesions have decreased by at least 75% from baseline; nodal non-target lesions have regressed to normal size; extranodal non-target lesions have disappeared; hepatomegaly/splenomegaly has disappeared; skin findings are Grade 0; peripheral blood is normal; BM infiltration is negative and no new lesions. A PR requires the SPD of target lesions has decreased by at least 50% from baseline; all nodal non-target lesions have regressed to normal or show no increase in size; all extranodal non-target lesions have disappeared"|From day 1 of study treatment to date of first documented CR, CRU or PR; Up to data cut-off date of 19 May 2017; maximum study duration was 134.1 weeks|The Efficacy Evaluable (EE) population consisted of all participants who met basic protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of lenalidomide|||percentage of participants||95% Confidence Interval|Number
2643887|NCT01724060|Secondary|Change in Macronutrient Composition From Baseline|Macronutrients difference between baseline and follow up|Change at 12 months|||||||
2643888|NCT01724060|Secondary|Change in Hepatic Insulin Resistance From Baseline|Insulin clamps difference between baseline and follow up|Change at 1 week after intervention|||||||
2643889|NCT01724060|Secondary|Change in Metabolites From Baseline|Blood samples difference between baseline and follow up|Change at 12 months|||||||
2643890|NCT01724060|Secondary|Change in Appetite Ratings From Baseline|Visual Analogues difference between baseline and follow up|Change 12 months|||||||
2643891|NCT01724060|Primary|Change in Energy Intake From Baseline|The difference in total calories consumption between baseline and 12 months|Change at 12 months|Patients that had specific obesity interventions.|||kcal||Standard Deviation|Mean
2643892|NCT01724021|Secondary|Summary of Observed Serum Rituximab Concentration||Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)|"The safety population included all participants who received at least one dose of rituximab. Here, Number Analyzed represents the number of participants who were evaluable at specified time points."|||microgram per milliter||Standard Deviation|Mean
2643893|NCT01724021|Secondary|Percentage of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies Over Time||Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)|"The safety population included all participants who received at least one dose of rituximab. Here, Number Analyzed represents the number of participants who were evaluable at specified time points."|||percentage of participants|||Number
2643894|NCT01724021|Secondary|Percentage of Participants With Anti-Rituximab Antibodies Over Time||Pre-dose Cycle 1 to 8, interim staging, final staging, 6, 12 months follow-up, end of study (Up to 4 years)|"The safety population included all participants who received at least one dose of rituximab. Here, Number Analyzed represents the number of participants who were evaluable at specified time points."|||percentage of participants|||Number
2643895|NCT01724021|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death from any cause.|From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)|ITT population included all participants who were randomized in the study.|||months||95% Confidence Interval|Median
2643914|NCT01723826|Primary|Percentage of Participants With Amyloid-Related Imaging Abnormalities Edema/Effusions (ARIA-E)|Alzheimer's disease (AD) is associated with ARIA. The occurrence of imaging abnormalities believed to represent cerebral vasogenic edema, has been reported in association with the investigational use of compounds that are intended to treat Alzheimer's disease by reducing Abeta in the brain. Here, the percentage of participants with symptomatic and asymptomatic ARIA-E were reported.|Baseline, Weeks 23, 47, 71, 97, 121 and 153|Safety Analysis population included all participants who received at least one dose of study drug.|||percentage of participants|||Number
2643896|NCT01724021|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from randomization to the first occurrence of progression or relapse, according to the IWG response criteria. IWG criteria is defined criteria using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; PR: At least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses; SD: participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for PD; PD: Lymph nodes considered abnormal if the long axis is more than 1.5 cm regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes <= 1.0 × <= 1.0 cm would not be considered as abnormal for PD.|From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)|ITT population included all participants who were randomized in the study.|||months||95% Confidence Interval|Median
2643897|NCT01724021|Secondary|Disease-free Survival (DFS)|DFS was defined as the period from the data of the initial CR/CRu until the date of relapse or death from any cause, whichever occurred first.|From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)|ITT population included all participants who were randomized in the study.|||months||95% Confidence Interval|Median
2643898|NCT01724021|Secondary|Event-free Survival (EFS)|EFS was defined as the time from randomization to first occurrence of progression or relapse according to IWG response criteria. IWG criteria is defined using the following response categories: CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy; partial response (PR): At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses; stable disease (SD): participants fails to attain the criteria needed for a CR or PR, but does not fulfill those for progressive disease (PD); PD: Lymph nodes considered abnormal if the long axis is more than 1.5 centimeter (cm) regardless of the short axis. Lymph node has a long axis of 1.1 to 1.5 cm, it is considered abnormal if its short axis is more than 1.0. Lymph nodes less than or equal to (<=) 1.0 × <= 1.0 cm would not be considered as abnormal for PD.|From the time of randomization until disease progression or 24 months post treatment follow up or which ever occur first (Up to 4 years)|ITT population included all participants who were randomized in the study.|||months||95% Confidence Interval|Median
2643899|NCT01724021|Secondary|Complete Response (CR) Rate|CR rate was assessed according to the International Working Group (IWG) Response Criteria (CHESON ET AL. 1999) and included CR and CR unconfirmed (CRu). CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by > 75 % but still >1.5 cm in size, and indeterminate bone marrow assessment. Tumor assessments were based on computed tomography (CT) scans with contrast of the neck, chest, and abdomen (if detectable by these techniques) or other diagnostic means, if applicable. Other methods (e.g., MRI) were acceptable for participants in whom contrast CT scans were contraindicated. Due to the limited availability of FDG-PET scanners, an FDG-PET scan was not mandated in the study.|28 days (± 3 days) after Day 1 of the last dose of induction treatment|ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.|||percentage of participants||95% Confidence Interval|Number
2643900|NCT01724021|Secondary|Rituximab Administration Satisfaction Questionnaire (RASQ) Score|The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.|During Cycle 4, 8 of treatment (Up to 32 weeks)|"ITT population included all participants who were randomized in the study. Here, Number Analyzed represents the number of participants who were evaluable at specified time points."|||units on a scale||Standard Deviation|Mean
2643901|NCT01724021|Secondary|Cancer Therapy Satisfaction Questionnaire (CTSQ) Score|CTSQ is a validated 16-item questionnaire that measures three domains related to participants' satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.|During Cycle 4, 8 of treatment (Up to 32 weeks)|"ITT population included all participants who were randomized in the study. Here, Number Analyzed represents the number of participants who were evaluable at specified time points."|||units on a scale||Standard Deviation|Mean
2643902|NCT01724021|Secondary|Time Required for Rituximab Administration (Subcutaneous [SC] or Intravenous [IV])|Administration time was defined as the time from start to end of the SC injection or from start to end of the IV infusion|Cycle 1-4, Cycle 5-8 for both SC and IV (Up to 32 weeks)|ITT population included all participants who were randomized in the study.|||minutes||Full Range|Median
2643903|NCT01724021|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Randomization of first participant to clinical cutoff date (Up to 4 years)|The safety population included all participants who received at least one dose of rituximab. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.|||participants|||Number
2643904|NCT01724021|Primary|Percentage of Participants Indicating a Preference for Rituximab Subcutaneous (SC) Over Rituximab Intravenously (IV) at Cycle 8|Participants who preferred rituximab SC over rituximab IV, along with the corresponding 95% confidence interval (CI), were estimated using the patient preference questionnaire (PPQ) after completing Cycle 8.|Cycle 8 (Up to 32 weeks)|ITT population included all participants who were randomized in the study. Number of participants analyzed specifies number of participants who were evaluable for the outcome measure.|||percentage of participants||95% Confidence Interval|Number
2648082|NCT01688141|Primary|Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study||Baseline and 3.5 years||||mean average eGFR change/mL/min/1.73 m^2||95% Confidence Interval|Mean
2643906|NCT01723904|Secondary|Change From Baseline to the End of Treatment Period in the Pittsburgh Sleep Quality Index (PSQI) Global Score|"The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire with 18 questions to assess sleep quality. The 18 questions are distributed to 7 elements with each element ranging from 0-3. The global score is the sum score of all 7 elements and ranges from 0-21 with higher values indicating worse sleep quality.~A negative value in Change from Baseline to Week 8 indicates an improvement in sleep quality from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.|||units on a scale||Standard Deviation|Mean
2643907|NCT01723904|Secondary|Change From Baseline to the End of Treatment Period in Parkinson's Disease Sleep Scale 2 (PDSS-2) Total Score|"The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep disturbance and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sum score of all 15 questions.~A negative value in Change from Baseline to Week 8 indicates an improvement from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.|||units on a scale||Standard Deviation|Mean
2643908|NCT01723904|Secondary|"Change From Baseline to the End of the Treatment Period in Time Spent on Without Troublesome Dyskinesia"|"Absolute time spent on without troublesome dyskinesia is measured in hours per day. A positive value in Change from Baseline to Week 8 indicates that the time spent on without troublesome dyskinesia increased from Baseline and therefore indicates an improvement from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.|||hours/day||Standard Deviation|Mean
2643909|NCT01723904|Primary|"Change From Baseline to the End of the Treatment Period in Absolute Time Spent Off"|"Absolute time spent off is measured in hours per day. A negative value in Change from Baseline to Week 8 indicates that the time spent off decreased from Baseline and therefore indicates an improvement from Baseline.~Only subjects with time spent off at Baseline (subset of the Full Analysis Set (FAS)) are included in the analysis of this outcome measure."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|"Subjects with time spent off at Baseline in the FAS with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64."|||hours/day||Standard Deviation|Mean
2643910|NCT01723904|Primary|"Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Average of on and Off State) Total Score"|"UPDRS Part II measures 'Activities in Daily Living'. The total score ranges from 0 (Best score possible) to 52 (Worst score possible).~UPDRS Part II total score (average of on and off state) is the average of UPDRS Part II total score (on state) and Part II total score (off state).~A negative value in Change from Baseline to Week 8 indicates an improvement in activities in daily living from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.|||units on a scale||Standard Deviation|Mean
2643911|NCT01723904|Primary|"Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (on State) Total Score"|"The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 to 108.~A negative value in Change from Baseline to Week 8 indicates an improvement in motor functions from Baseline."|From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64.|||units on a scale||Standard Deviation|Mean
2643912|NCT01723904|Primary|Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period|"The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows: 0 = Side effects not assessable~= No side effects~= Side effects do not significantly interfere with subject's functioning~= Side effects significantly interfere with the subject's functioning~= Side effects outweigh therapeutic efficacy."|Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period)|From the 90 subjects in the Safatey Set, 89 are included in the analysis of this outcome measure. Last Observation Carried Forward (LOCF) was used as a method of imputation for missing observations.|||participants|||Number
2643913|NCT01723826|Primary|Percentage of Participants With Amyloid-Related Imaging Abnormalities-Hemorrhage (ARIA-H)|AD is associated with ARIA. Cerebral micro-hemorrhages (microbleeds [MBs]) are radiologically defined as small dot-like foci of signal loss observed on magnetic resonance imaging (MRI) sequences sensitive for paramagnetic tissue properties. The occurrence of MBs has also been identified as an adverse event in anti-amyloid vaccination trials, and together with superficial siderosis, they have been termed ARIA-H.|Baseline, Weeks 23, 47, 71, 97, 121 and 153|Safety Analysis population included all participants who received at least one dose of study drug.|||percentage of participants|||Number
2648472|NCT01685021|Secondary|Pharmacokinetics of MOR00208|Steady State Trough Plasma Concentration (Cpre-dose) at 9th dose (infusion)|weekly, up to 16 weeks, based on samples taken Pre-dose (ie before infusion start)||||mcg/mL||Standard Deviation|Mean
2643916|NCT01723826|Primary|Percentage of Participants by Severity of AEs|AE severity grading scale for the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 was used for assessing adverse event severity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on the following general guideline: Grade 1) mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2) moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL), Grade 3) severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4) life-threatening consequences; urgent intervention indicated, Grade 5) death related to AE.|Up to 50 months|Safety Analysis population included all participants who received at least one dose of study drug.|||percentage of participants|||Number
2643917|NCT01723826|Primary|Percentage of Participants by Nature of AEs|A serious adverse event (SAE) is any AE that meets any of the following criteria: fatal, life threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in a neonate/infant. Non-SAE of special interest for this study include the following: cerebral vascular edema, Superficial siderosis of central nervous system, cerebral micro-hemorrhages or macro-hemorrhages, pneumonia, liver injury.|Up to 50 months|Safety Analysis population included all participants who received at least one dose of study drug.|||percentage of participants|||Number
2643918|NCT01723826|Primary|Percentage of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. . An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to 50 months|Safety Analysis population included all participants who received at least one dose of study drug.|||percentage of participants|||Number
2643919|NCT01723722|Primary|Length of Treatment With Opioid Medication|Up to 12 months|Up to 12 months|Completion of treatment|||days||Standard Deviation|Mean
2643920|NCT01723696|Secondary|Incidence of Wheezing Through 12 Months of Age|The incidence of wheezing through 12 months of age will be compared in the infants delivered to smoking pregnant women who were randomized to vitamin C (500 mg) versus placebo during pregnancy.|12 months of age|Population is infants who have reached 12 months of age, and whose parent/caregiver has completed at least 1 respiratory questionnaire past 122 days after birth.|||Participants|||Count of Participants
2643921|NCT01723696|Secondary|Forced Expiratory Flow at 75% of Expired Volume (FEF75)|The measurement of forced expiratory flows and specifically FEF75 will be done at 12 months of age in infants born to pregnant smoking women randomized to vitamin C versus placebo during pregnancy. FEF75 will be measured with the raised volume rapid thoracic compression technique.|12 months of age|These measurements were performed at the 12 month visit.|||mL/s||Standard Deviation|Mean
2643922|NCT01723696|Primary|Forced Expiratory Flow at 75% of Expired Volume (FEF75)|The primary outcome was the comparison of infant FEFs at 3 months of age obtained using the raised volume rapid thoracic compression (RVRTC) technique in offspring of pregnant smokers randomized to vitamin C versus placebo. The specific primary outcome parameter was the measurement of FEF at 75% of the expired volume (FEF75)|3 months of age|Population included in analysis were infants who were able to complete technically acceptable PFT/FEF measurements at 3 months of age.|||ml/s||Standard Deviation|Mean
2643923|NCT01723514|Secondary|Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow|"Inhibition of capsaicin-induced dermal blood flow (DBF) by erenumab was used to measure calcitonin gene-related peptide (CGRP) receptor antagonism. Capsaicin was applied at 2 sites on the volar surface of the participants' left or right forearms and a control mixture was applied to 1 site on the volar surface of either the participants' left or right forearm. Dermal blood flow was assessed by laser Doppler perfusion imaging and was done immediately before ('baseline') and 0.5 hours post-capsaicin on the surface of these 3 sites.~Data reported are the least square geometric mean ratios for the post-capsaicin dermal blood flow to pre-capsaicin dermal blood flow.~According to the protocol, not all cohorts had dermal blood flow measurements at all time points."|Baseline, Days 8, 57, 85, 113, 169 and 197|All participants for whom at least 1 postdose capsaicin response measure was recorded. Measurement and analysis of dermal blood flow were not performed in the 280/210 cohort.|||ratio||Standard Error|Geometric Least Squares Mean
2643924|NCT01723514|Secondary|Area Under the Serum Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)|Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).|Day 57 (assessed from predose to day 225))|All participants who received erenumab and for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point.|||day*μg/mL||Standard Deviation|Mean
2643925|NCT01723514|Secondary|Area Under the Serum Concentration-Time Curve From 0 to 28 Days (AUC0-28day)|Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).|Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)|All participants for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point.|||day*μg/mL||Standard Deviation|Mean
2643926|NCT01723514|Secondary|Time to Maximum Observed Concentration (Tmax) of Erenumab|Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).|Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)|All participants for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point.|||days||Full Range|Median
2643927|NCT01723514|Secondary|Maximum Observed Serum Concentration (Cmax) of Erenumab|Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).|Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)|All participants for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point.|||μg/mL||Standard Deviation|Mean
2644218|NCT01721096|Secondary|Number of Participants With All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|3 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2643928|NCT01723514|Primary|Number of Participants Who Developed Anti-erenumab Antibodies|"Participants who had a negative or no result at baseline and were antibody positive postbaseline.~Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies."|From first dose of study drug until a maximum of 168 days after last dose (225 days)|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2643929|NCT01723514|Primary|Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)|The C-SSRS is a measure of suicidal ideation and behavior. Ideation includes a wish to be dead or nonspecific thoughts about wanting to end life. Suicidal behavior includes actual attempts, interrupted or aborted attempts, and any preparatory acts.|From first dose of study drug until a maximum of 168 days after last dose (225 days)|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2643930|NCT01723514|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events.~Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug.~A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:~fatal~life-threatening (places the subject at immediate risk of death)~requires in-patient hospitalization or prolongation of existing hospitalization~results in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event."|From first dose of study drug until a maximum of 168 days after last dose (225 days)|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2643931|NCT01723397|Primary|Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent|Change in total nasal symptom score after nasal challenges (the change is calculated as the total nasal symptom score after allergen challenge - total nasal symptom score after diluent challenge) on the second of two days of nasal challenges following one week of pretreatment with Nasaleze or placebo. The nasal symptoms included number of sneezes, symptoms of runny and stuffy nose (separately for each nostril), and itchy nose/throat symptoms. Individual symptoms were score on a scale from 0-3 (0=no symptoms, 1=mild, 2=moderate, 3=severe). The maximum total nasal symptom score possible was 15 with higher scores indicating worse symptoms.|Day 2 after one week pretreatment with Nasaleze or placebo.|The analysis population includes the 12 participants who completed the study.|||units on a scale||Full Range|Median
2643932|NCT01723384|Primary|Tolerability to Study Drug, as Measured by Adverse Events|Frequency of Adverse Events, by arm|2 months||||Count|||Number
2643933|NCT01723384|Primary|Acceptability to Taking Medication|Mean number of pills taken weekly, as determined by recorded openings from an electronic monitoring device for study medication pill dispensers|2 month follow-up||||number of wisepill openings by week||Standard Deviation|Mean
2643934|NCT01723384|Primary|Feasibility of Retaining Participants in Trial|Proportion of persons retained by study arm.|proportions eligible and enrolled assessed on ongoing basis throughout the study, proportion of visits completed assessed bi-weekly for each participant; overall retention assessed over 2 month follow-up for each participant||||percentage that completed study|||Number
2643935|NCT01723254|Secondary|Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336|Ability of vaccine induced serum anti-immunoglobulin E (IgE) antibodies to interfere with IgE binding to recombinant alpha chain of the high affinity IgE receptor was assessed in an ELISA based assay. GMTs were calculated both as crude means (unadjusted) and by an analysis of covariance (ANCOVA) model with natural log transformed antibody titer as outcome variable, and treatment group as factor and baseline (in log scale) as covariates at each of the post dose measurement.|Baseline (Day 1), Day 182 (2 weeks after last vaccination), and end of study (Day 336)|All randomized participants who received at least 1 dose of randomized treatment, n=number of evaluable participants at the specified time point.|||units/milliliter (u/mL)||80% Confidence Interval|Number
2643936|NCT01723254|Primary|Number of Participants With Laboratory Test Abnormalities|Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, hormones, clinical chemistry, immunology urinalysis, urinalysis (dipstick and microscopy), and other tests such as human immunodeficiency virus antibody and hepatitis C antibody.|Baseline up to 336 days post last study drug administration or Early Termination|All randomized participants who received at least one dose of study treatment.|||participants|||Number
2643937|NCT01723254|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severe TEAEs were those that interfered significantly with the participant's usual function. Causality assessment was made by the investigator.|Baseline up to 336 days post study administration or at Early Termination|All randomized participants who received at least one dose of study treatment.|||participants|||Number
2643947|NCT01722994|Secondary|Presence of Infection|Any infected wounds were documented. A scale of 0-1 was used (0=absence; 1= present).|3 weeks|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.|||participants|||Number
2643948|NCT01722994|Primary|Presence of Scarring|All subjects will be examined 1 week and 3 weeks after the wounds are closed with absorbable suture to assess the presence or absence of scarring. A scale of 0-1 was used (0=absent; 1=present).|3 weeks|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.|||participants|||Number
2643938|NCT01723254|Primary|Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination|Systemic reactions consisted of fever, vomiting, diarrhea, headache, fatigue, muscle pain (other than at the injection site) and joint pain (other than pain adjacent to injection site). Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any systemic reactions for 14 days following each vaccination. Grading details are as follows: Mild (Vomiting: 1-2 times in 24 hours; Diarrhea: 2-3 loose stools in 24 hours; Headache, Fatigue, Muscle Pain, Joint Pain: no interference with activity), Moderate (Vomiting: >2 times in 24 hours; Diarrhea: 4-5 loose stools in 24 hours; Headache, Fatigue, Muscle and Joint Pain: some interference with activity), Severe (Vomiting: required intravenous hydration; Diarrhea: more than or equal to [>=] 6 stool in 24 hours; Headache, Fatigue, Muscle and Joint Pain: Significant, prevented daily activity).|Within 14 days|All randomized participants who received at least one dose of study treatment.|||Percentage of participants||80% Confidence Interval|Number
2643939|NCT01723254|Primary|Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination|Local reactions consisted of any pain at the site of injection, any swelling, and any redness. Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any local reactions for 14 days following each vaccination. Grading details are as follows: Mild (Pain: did not interfere with activity; Redness and Swelling: 0.5-5.0 centimeters [cm] or 1-10 caliper units), Moderate (Pain: interfered with activity; Redness and Swelling: more than [>] 5.0 to 10.0 cm or 11-20 caliper units), Severe (Pain: prevented daily activity; Redness and Swelling: >10 cm or 21 caliper units and above).|Within 14 days|All randomized participants who received at least one dose of study treatment.|||Percentage of participants||80% Confidence Interval|Number
2643940|NCT01723228|Secondary|Change From Baseline to Week 24 in UPDRS, Activities of Daily Living (ADL) Subscale (Part 2), Version 3, Score|UPDRS Part 2 (ADL subscale) comprises 13 items evaluating the impact of PD on patients' ADL (in both the on and off states) in the week prior to the visit. The following 13 ADL are assessed: speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting bed clothes, falling (unrelated to freezing), freezing when walking, walking, tremor, and sensory complaints related to Parkinsonism. Each item is assessed on a scale from 0 (normal, absent, or none) to 4 (severe impairment), which are summed to get the sub-scale score. The total scale is 0-52 with a higher score indicating more severe symptoms; a decrease in the scores indicates improvement.|Baseline to week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline UPDRS ADL Subscale (Part 2) assessment.|||units on a scale||Standard Error|Least Squares Mean
2643941|NCT01723228|Secondary|Change From Baseline to Week 24 in the Unified Parkinson's Disease Rating Scale (UPDRS), Motor Subscale (Part 3), Version 3, Score|UPDRS Part 3 (motor examination subscale) comprises 14 items assessing the motor disabilities of the patient at the time of the visit. The participant's speech, facial expressions, ability to arise from a chair (with arms folded), posture, gait, postural stability (retropulsion test), and body bradykinesia and hypokinesia are assessed. In addition, the following evaluations require assessment of the face, neck or extremities: tremor at rest, action or postural tremor of hands, rigidity, finger taps, hand movements (open and close), rapid alternating movements of hands (pronation and supination), and leg agility (tap heel on ground). This evaluation is performed while the participant is in the 'on' phase. Each item is assessed on a scale from 0 (normal, absent, or none) to 4 (severe impairment), which are summed to get the sub-scale score. The total scale is 0-57 with a higher score indicating more severe symptoms; a decrease in the scores indicates improvement.|Baseline to Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline UPDRS Motor Subscale (Part 3) assessment.|||units on a scale||Standard Error|Least Squares Mean
2643942|NCT01723228|Secondary|Alzheimer's Disease Cooperative Study's Clinical Global Impression of Change Modified for Mild Cognitive Impairment (ADCS MCI-CGIC) Score at Week 24|The ADCS MCI-CGIC score is generated in the context of a semi-structured interview and is an indication of the change in the participant's global status, cognition, behavior, and functional abilities (FA) on a 7-point scale, with the best score being 'marked improvement' and the worst being 'marked worsening.'|Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline ADCS MCI-CGIC assessment. n=number of participants with the given assessment.|||participants|||Number
2643943|NCT01723228|Secondary|Change From Baseline to Week 24 in the Penn Daily Activities Questionnaire (PDAQ) Score|The PDAQ is a 15-item questionnaire that assesses the patient's difficulty with activities of daily living. The total score has a range of 0 (no impairment) to 60 (severe impairment).|Baseline to Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline PDAQ assessment.|||units on a scale||Standard Error|Least Squares Mean
2643944|NCT01723228|Secondary|Change From Baseline to Week 24 in the Montreal Cognitive Assessment (MoCA) Score|The MoCA assesses 8 cognitive areas: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. Scores range from 0 (worst) to 30 (best).|Baseline to Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline MoCA assessment.|||units on a scale||Standard Error|Least Squares Mean
2643945|NCT01723228|Primary|Mean Change From Baseline to Week 24 in the Scales for Outcomes in Parkinson's Disease-Cognition (SCOPA-COG) Summary Score|The SCOPA-COG consists of evaluations in 4 domains: memory, attention, executive functioning, and visuospatial functioning.Scores range from 0 to 43, with higher scores reflecting better performance.|Baseline to Week 24 (or early discontinuation)|Modified intent-to-treat population: all participants who were randomized, received at least 1 dose of study drug and had at least 1 postbaseline SCOPA-COG assessment.|||units on a scale||Standard Error|Least Squares Mean
2643946|NCT01723163|Primary|Number of Participants With Abstinence or Non-Abstinence at 6-month Follow-up|Non-abstinence is defined as smoking for 7 consecutive days or at least once a week for 2 consecutive weeks. Non-abstinence was evaluated for the 90 days previous to the 6 month follow-up.|6-month post-treatment||||Participants|||Count of Participants
2643950|NCT01722994|Secondary|Length of Time Till Absorbable Suture Fall Out|The time post placement when the suture fell out.|3 weeks|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.|||Days||Standard Deviation|Mean
2643951|NCT01722994|Primary|Presence of Scarring|All subjects will be examined 1 week and 3 weeks after the wounds are closed with absorbable suture to assess the presence or absence of scarring. A scale of 0-1 was used (0=absent; 1=present).|1 week|Of the 97 subjects who enrolled, 49 had punch biopsy site closure with chromic gut and 48 with polyglactin 910 sutures. 42 subjects were lost to follow-up or had missing data. Of the 55 subjects who completed the study - 24 received chromic gut and 31 received polyglactin 910.|||participants|||Number
2643952|NCT01722929|Primary|Measure Temperature at 3 Time Points||Baseline, 48 hours from baseline, and 2 weeks from baseline||||Degrees Celsius||Standard Deviation|Mean
2643953|NCT01722877|Other Pre-specified|Acute Device Success|Acute device success is defined as less than or equal to 50% residual stenosis at the index lesion using the JetStream device alone and with no adjunctive balloon angioplasty therapy (via Quantitative Vascular Analysis) and with no serious adverse events.|intraprocedural||||limbs|limbs||Count of Units
2643954|NCT01722877|Secondary|Target Lesion Revascularization|Reintervention on the same index lesion at 6 months|6 months||||lesions|lesions||Count of Units
2643955|NCT01722877|Secondary|Patency|Patency is defined as Peak Systolic Velocity Ratio (PSVR) of < 2.4 by duplex criteria. PSVR is obtained by dividing velocity (cm/sec) at the lesion site to the velocity immediately proximal to the lesion.|6 months|Only 25 limbs had duplex ultrasound at 6 months.|||Percentage of patent limbs|limbs||Number
2643956|NCT01722877|Primary|Acute Procedural Success|Acute procedural success is defined as less than or equal to 30 percent residual stenosis (via Quantitative Vascular Analysis) at the index lesion post JestStream atherectomy and final adjunctive treatment And with no serious adverse events.|intraprocedural||||limbs|limbs||Count of Units
2643957|NCT01722734|Primary|Self-reported Adherence to Artemisinin-combination Therapy (ACT) Treatment|Percentage of participants completing full ACT treatment regimen 70 hours after treatment initiation. Subjects were visited at home, and asked to report when each of the prescribed six doses were taken. Adherence was defined as the (self-reported) completion of all six doses.|70 hours|The number of subjects analyzed is smaller than the number of subjects enrolled due to missing data on adherence. A total of 30 observations were lost due to missing information on adherence - 16 in the control group, 9 in the short message group, and 5 in the long message group.|||percentage of participants||95% Confidence Interval|Number
2643958|NCT01722643|Secondary|Daily Frequency of Self Monitoring of Blood Glucose Checks 12 Months Following Enrollment|Participants will use a glucometer to self-monitor blood glucose daily. Readings from the glucometer will be uploaded at each session and at the follow up visits. The glucometer records the blood glucose level as well as a date/time stamp over a 90 day period. To assess the daily testing frequency, the total number of blood glucose tests a day during the 14 days prior to each assessment will be recorded from the study provided glucometer.|12 months following enrollment|1 participant in the MaxIM arm and 1 participant in the Usual Care arm did not provide meter data at 12 months so do not have data for this outcome.|||readings per day||Standard Error|Least Squares Mean
2643959|NCT01722643|Primary|HbA1c at 12 Months|Glycated hemoglobin test (HbA1c) measures the non-enzymatic glycation status of hemoglobin expressed in percentage points. Analyses control for pump status, diabetes duration and baseline HbA1c|12 months following enrollment||||percentage glycated hemoglobin||Standard Error|Least Squares Mean
2643960|NCT01722552|Secondary|Proportion of Subjects Who Achieve >/= 95% Cumulative Adherence Over Entire 6 Months of Intervention Period|Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers.|6 months||||Participants|||Count of Participants
2643961|NCT01722552|Primary|Difference in Proportion of Subjects Who Achieve >/= 95% Adherence|Subjects will participate in the 6-month real-time feedback intervention. Comparison patients will continue to be monitored by Wisepill, but they will remain blinded to the adherence information generated by the Wisepill devices, as will their care providers.|Measured at 6 months after start of intervention||||Participants|||Count of Participants
2643962|NCT01722487|Secondary|Proportion of Sustained Platelet Improvement in Subjects With Baseline Thrombocytopenia|In randomized subjects with baseline platelet ≤ 100 x 10^9/L, the proportion of subjects who achieved platelet >100 x 10^9/L or increase ≥50% over baseline persisted continuously for ≥56 days (8 wee without blood transfusion or growth factors.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with cutoff date of 4 May 2015. The median follow-up time is 18 month.|Subjects With Baseline Thrombocytopenia|||Percentage of Participants|||Number
2643963|NCT01722487|Secondary|Proportion of Sustained Platelet Improvement|The proportion of subjects who achieved platelet >100 x 10^9/L or increase ≥50% over baseline and persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat|||Percentage of Participants|||Number
2643964|NCT01722487|Secondary|Proportion of Sustained Hemoglobin Improvement in Subjects With Baseline Anemia|In randomized subjects with baseline hemoglobin ≤ 11 g/dL, the proportion of subjects who achieved Hemoglobin >11 g/dL or increase ≥ 2 g/dL over baseline persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Subjects with Baseline Anemia|||Percentage of Participants|||Number
2643965|NCT01722487|Secondary|Proportion of Sustained Hemoglobin Improvement|The proportion of subjects who achieved Hemoglobin >11 g/dL or increase ≥ 2 g/dL over baseline and persisted continuously for ≥56 days (8 weeks) without blood transfusion or growth factors.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat|||Percentage of Participants|||Number
2643966|NCT01722487|Secondary|ORR (Overall Response Rate)|ORR is defined as the proportion of subjects who achieved complete response (CR), complete response with incomplete marrow recovery (CRi), nodule partial response (nPR) or PR per IRC assessment. Response criteria are as outlined in the International Workshop on CLL (iwCLL) 2008 criteria with the 2012 iwCLL modification stating that treatment-related lymphocytosis in the setting of improvement in other parameters was not considered as PD and the 2013 iwCLL clarification of criteria for a partial response to therapy.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat|||percentage of participants|||Number
2643967|NCT01722487|Secondary|Overall Survival (OS)|OS is calculated for all randomized subjects as the duration of time from the date of randomization to the date of death due to any cause or the date last known alive for subjects who were not known to have died at study closure.|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat|||Months||95% Confidence Interval|Median
2643968|NCT01722487|Primary|PFS (Progression Free Survival)|"The primary objective of this study was to evaluate the efficacy of Ibrutinib compared with Chlorambucil based on the independent review committee (IRC) assessment of PFS~Progressive disease according to 2008 IWCLL guidelines was defined as:~Group A~Lymphadenopathy, increase ≥50%~Hepatomegaly, increase ≥50%~Splenomegaly, increase ≥50%~Blood lymphocytes, increase ≥ 50% over baseline~Group B~Platelets counts, decrease of ≥ 50% from baseline secondary to CLL~Hemoglobin, decrease of > 2 g/dL from baseline secondary to CLL"|Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.|Intention to treat|||Months||95% Confidence Interval|Median
2643969|NCT01722435|Secondary|Mean Time Staying in OST|Mean time of study participation (M, SD) of patients who stayed in OST Treatment until end of study (after 18 months).|18 months||||days||Standard Deviation|Mean
2643970|NCT01722435|Secondary|Mean Time to Drop-out of OST|Mean time of study participation (M, SD) until drop-out of treatment.|18 months||||days||Standard Deviation|Mean
2643971|NCT01722435|Secondary|Mean Time to Complete OST|Mean time of study participation (M, SD) until Treatment completion or end of study (after 18 months).|18 months||||days||Standard Deviation|Mean
2643972|NCT01722435|Primary|OST Drop-outs|Participants dropped out of OST Treatment during the study period.|18 months||||participants|||Number
2643973|NCT01722435|Primary|Completion of OST|Regularly completion of OST, i.e. not being on opioid medication any more, during the study period.|18 months||||participants|||Number
2643974|NCT01722331|Secondary|Percentage of Participants With DLQI Score of 0 or 1 at Week 12|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.|Week 12 (or end of trial if prior to Week 12)|Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have a DLQI measurement at Week 12 (or end of trial if prior to Week 12).|||Percentage of participants|||Number
2643975|NCT01722331|Secondary|Change From Baseline in the Participant DLQI Score at Week 12|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. For a change from baseline, a larger negative number correlates with a greater improvement in the DLQI score.|Baseline and Week 12 (or end of trial if prior to Week 12)|Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have at least one DLQI measurement (post-baseline or baseline).|||Score on a scale||95% Confidence Interval|Least Squares Mean
2643976|NCT01722331|Secondary|Baseline Dermatology Life Quality Index (DLQI) Score|The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.|Baseline|Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have baseline DLQI measurement|||Score on a scale||Standard Deviation|Mean
2643977|NCT01722331|Secondary|Percentage of Participants With PASI-100 Response at Week 12|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.|Week 12 (or end of trial if prior to Week 12)|Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.|||Percentage of participants|||Number
2643978|NCT01722331|Secondary|Percentage of Participants With PASI-90 Response At Week 12|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.|Week 12 (or end of trial if prior to Week 12)|Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.|||Percentage of participants|||Number
2643979|NCT01722331|Primary|Number of Participants Discontinuing Study Drug Due to an Adverse Event (Extension Study)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 192 weeks||2020-05-31|05/2020||||
2644219|NCT01721096|Secondary|Number of Participants With All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|2 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2643982|NCT01722331|Primary|Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study)|A drug-related adverse event is an adverse event that has been determined by the investigator to be related to the study drug.|Up to 12 weeks|Analysis population included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.|||Participants|||Count of Participants
2643983|NCT01722331|Primary|Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 12 weeks|Analysis population included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.|||Participants|||Count of Participants
2643984|NCT01722331|Primary|Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study)|An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 12 weeks|Analysis population included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.|||Participants|||Count of Participants
2643985|NCT01722331|Primary|Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Base Study)|The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.|Baseline and Week 12 (or end of trial if prior to Week 12)|Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.|||Percentage of Participants|||Number
2643986|NCT01722331|Primary|Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study)|The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.|Week 12 (or end of trial if prior to Week 12)|Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.|||Percentage of Participants|||Number
2643987|NCT01722318|Secondary|Change From Baseline in Straining Scores Over 12-Week Treatment Period (mITT Population)|The severity of straining (Straining Score) was rated by the patients using a 11-point scale (0-10) where 0 = none and 10 = very severe|12-Week Treatment Period|The Modified Intent-to-Treat (mITT) population included all randomized patients who received ≥ 1 dose of study drug and ≥ 1 post-baseline BM assessment was the primary analysis population analyzed for efficacy endpoints.|||score on a scale||Standard Error|Least Squares Mean
2643988|NCT01722318|Secondary|Change From Baseline in Stool Consistency (BSFS) Over 12-Week Treatment Period (mITT Population)|"The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale [BSFS] from 1 to 7.~= separate hard lumps like nuts (difficult to pass)~= sausage shaped but lumpy~= like a sausage but with cracks on its surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges (passed easily)~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces (entirely liquid)"|12-Week Treatment Period|The Modified Intent-to-Treat (mITT) population included all randomized patients who received ≥ 1 dose of study drug and ≥ 1 post-baseline BM assessment was the primary analysis population analyzed for efficacy endpoints.|||scores on a scale||Standard Error|Least Squares Mean
2643989|NCT01722318|Secondary|Change From Baseline in Abdominal Pain Intensity Scores Over 12-Week Treatment Period (mITT Population)|Abdominal Pain was assessed in the patient's daily response on a scale of 0 to 10 where 0 is did not experience the symptom at all and 10 is experienced the worst.|12-Week Treatment Period|The mITT population included all randomized patients who received at least 1 dose of study drug and who had at least 1 post-baseline Bowel Movement (BM) assessment was the primary analysis population for efficacy endpoints.|||scores on a scale||Standard Error|Least Squares Mean
2643990|NCT01722318|Primary|Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population)|The primary efficacy endpoint was the change from baseline in the weekly CSBM frequency (CSBMs per week minus CSBMs per week at baseline) over a 12-week Treatment Period. A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation.|12 weeks Treatment Period|The Modified Intent-to-Treat (mITT) population included all randomized patients who received ≥ 1 dose of study drug and ≥ 1 post-baseline BM assessment was the primary analysis population analyzed for efficacy endpoints.|||CSBMs per week||Standard Error|Least Squares Mean
2643991|NCT01722292|Secondary|Phase 1b and 2: Pharmacokinetics: Time to Maximal Concentration (Tmax) of Carboplatin and Etoposide at the Recommended Dose||Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours|All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped. C and E doses did not change for the 3 cohorts of LY (100,200 and 400 mg) so we only need to report one grouping.|||Hour (h)||Full Range|Median
2643992|NCT01722292|Secondary|Phase 1b and 2: Pharmacokinetics: Time to Maximal Concentration (Tmax) of LY2940680 andLSN3185556 at the Recommended Dose||Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours|All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.|||Hour (h)||Full Range|Median
2643996|NCT01722292|Secondary|Phase 1b: Percentage Inhibition of Expression Levels of Gli1 in Skin Cells|The gene expression data (Gli1) was normalized and the level of percentage of Gli1 inhibition post treatment was calculated.|Baseline, Cycle 2 Day 1, Cycle 7 Day 1|All participants who received at least one dose of drug and had samples available.|||Percentage of Gli 1 Inhibition||Inter-Quartile Range|Median
2643997|NCT01722292|Secondary|Phase 1b: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])|ORR was defined as the percentage of all randomized participants with the best overall response of PR or CR using Response Evaluation Criteria in Solid Tumors (RECIST v1.1). CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.|Baseline to Study Completion Up to 39 Months|All participants who received at least one dose of drug.|||percentage of participants||90% Confidence Interval|Mean
2643998|NCT01722292|Secondary|Phase 1b and 2: Pharmacokinetics: Area Under the Curve ( AUC₀-₂₄) for Etoposide and as AUC₀-₆ for Carboplatin at the Recommended Dose||Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours|"All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.~C and E doses did not change for the 3 cohorts of LY (100,200 and 400 mg) so we only need to report one grouping."|||Hour*microgram per milliliter (h.µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2643999|NCT01722292|Secondary|Phase 1b and 2: Pharmacokinetics: Area Under the Curve ( AUC₀-₂₄) for LY2940680 and LSN3185556 at the Recommended Dose||Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours|All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.|||Hour*microgram per milliliter (h.µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2644000|NCT01722292|Secondary|Phase 1b and 2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Carboplatin and Etoposide at the Recommended Dose||Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours|"All participants who received at least one dose of study drug and were enrolled in Phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.~C and E doses did not change for the 3 cohorts of LY (100,200 and 400 mg) so we only need to report one grouping."|||microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2644001|NCT01722292|Secondary|Phase 1b and 2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2940680, LSN3185556 at the Recommended Dose||Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours|All participants who received at least one dose of study drug and were enrolled in Phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.|||microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2644002|NCT01722292|Primary|Phase 2: Progression-Free Survival||Randomization to Measured Progressive Disease or Death of Any Cause (Estimated as 18 Months)|Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.||||||
2644003|NCT01722292|Primary|Phase 1b: Recommended Phase 2 Dose of LY2940680: Maximum Tolerated Dose (MTD)|MTD was defined as the highest tested dose that has <33% probability of causing a dose-limiting toxicity(DLT). DLT was defined as an AE during Cycle 1 that is possibly related to the study drug and fulfills any one of the following criterion using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE),version 4.0:Grade 3 non-hematological toxicity except nausea, vomiting, constipation, diarrhea, fatigue, or anorexia that is manageable with appropriate care,transient(i.e., ≤5 days) Grade 3 elevations of alanine aminotransferase(ALT) and/or aspartate aminotransferase(AST), without evidence of other hepatic injury, in the setting of preexisting hepatic metastasis, ≥Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia of any duration,CTCAE Grade 4 hematological toxicity of >5 days duration and any febrile neutropenia. any other significant toxicity deemed by the primary investigator and Lilly clinical research personnel to be dose-limiting.|Baseline to Completion of the Phase 1b (Up To 12 Months)|All participants who received at least one dose of study drug and were enrolled in Phase1b of the study.|||milligrams (mg)|||Number
2644004|NCT01722266|Secondary|Insulin, C-peptide, Glucagon, GLP-1(Glucagon Like Peptide-1) and GIP(Gastric Inhibitory Polypeptide) Concentrations Following Meal Challenge.||12 weeks|||||||
2644005|NCT01722266|Secondary|Carbohydrate Intake||12 weeks||||grams||Standard Error|Mean
2644006|NCT01722266|Secondary|Serum Acetaminophen Concentrations Following Meal Challenge||12 weeks|||||||
2644007|NCT01722266|Secondary|Reduction in the Area Under Curve(AUC) of Glucose Following the Meal||12 weeks|||||||
2644008|NCT01722266|Secondary|Percent Time Spent in Hyperglycemia and Hypoglycemia||12 weeks|||||||
2644009|NCT01722266|Secondary|Change in Total Insulin Dose From Baseline at 12 Weeks|Total insulin dose = Basal insulin dose plus bolus insulin dose.|Baseline and 12 weeks||||Units||Standard Error|Mean
2644010|NCT01722266|Secondary|Change in Body Weight From Baseline at Week 12||Baseline and 12 weeks||||Kg||Standard Error|Mean
2644011|NCT01722266|Secondary|Change in HbA1c From Baseline at 12 Weeks||Baseline and 12 Weeks||||Percent||Standard Error|Mean
2644012|NCT01722266|Primary|Change in Mean Weekly Glucose Concentrations From Baseline at 12 Weeks|The primary endpoint of the study is to detect a difference from baseline in mean weekly blood glucose concentrations before and after 12 weeks of treatment in each of the Liraglutide groups.|12 Weeks||||mg/dl||Standard Error|Mean
2644013|NCT01722162|Primary|Progression Free Survival (Arm B)|"Time from start of treatment to the time of progression or death, whichever occurs first~Progressive disease (target lesions): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Progressive disease (non-target lesions): appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase."|Until progressive disease (PD) (up to 60 days)||||proportion of patients with PFS||95% Confidence Interval|Number
2644014|NCT01722162|Secondary|Incidence and Severity of Adverse Events as Measured by Number of Participants Who Experience Grade 3 and Higher Adverse Events|NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|Up to 6 months|Arm A: 4 patients not evaluable for outcome measure (2 had unrelated adverse events after enrollment but prior to treatment, 1 withdrew consent after enrollment but prior to treatment, & 1 was found ineligible after enrollment but prior to treatment). Arm B: 1 patient not evaluable because of noncompliance after enrollment but before treatment|||participants|||Number
2644015|NCT01722162|Primary|Progression Free Survival (Arm A)|"Time from start of treatment to the time of progression or death, whichever occurs first~Progressive disease (target lesions): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Progressive disease (non-target lesions): appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase."|Until progressive disease (PD) (estimated to be 92 days)||||proportion of patients with PFS||95% Confidence Interval|Number
2644016|NCT01722097|Other Pre-specified|Patient-movements|Number of unintended and unwanted patient-movements registered by the surgeon|During surgery|||||||
2644017|NCT01722097|Secondary|Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)|"Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 4 days after operation.~Pain (shoulder-, incisional-, abdominal - and overall pain) estimated as area under the curve (AUC) from 0 till 14 days after operation.~Pain was assessed: preoperatively, at arrival to the postanesthesia care unit, 2 hours after surgery, 4 hours after surgery, 8 hours after surgery, at discharge from hospital, and once daily at day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14 after surgery."|within 14 days||||units on a scale*days||Inter-Quartile Range|Median
2644018|NCT01722097|Primary|Shoulder Pain|"Number of participants with shoulder pain or discomfort (VAS > 20) in the shoulder region within 14 days after operation.~VAS 0-100: Visual analouge scale for assessment of pain ranging from no pain (value 0) to worst kind of pain (value 100)."|within 14 days||||participants|||Number
2644019|NCT01722071|Primary|Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment.|"Drug effect will be assessed by ascertaining changes in brain activity between placebo and oxytocin sessions.~Imaging data will be analyzed from all subjects in a final analysis. Individual subject analyses will be done on a bimonthly basis.~Results represent neural responses to the anticipation of an uncertain reward within the Nucleus Accumbens (Bilateral). These are given as beta values (i.e. parameter estimates)."|Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).|Only 8 participants' BOLD data were included in the final group analysis in the Placebo then Oxytocin arm -- 1 participant was excluded from the study prior to scanning, 1 participant was scanned but due to technical issues the BOLD data was not used.|||BOLD signal change (beta values)||Standard Error|Mean
2644020|NCT01722045|Other Pre-specified|Percent Change From Baseline in Corneal Endothelial Cell Density (ECD) at Week 24 and Week 52 in the Study Eye and the Fellow Eye - Endothelial Cell Density Evaluable Set (EES)|EES included all eligible patients who were treated in the study eye, untreated in the fellow eye, had baseline specular microscopy image in both eyes, and completed week 52 evaluation in both eyes and treatment with systemic anti-VEGF therapeutics|At week 24 and At week 52|EES|||percent change from baseline||Standard Deviation|Mean
2644021|NCT01722045|Secondary|Percentage of Patients Who Lost >0, ≥5, ≥10, or ≥15 Letters From Baseline in BCVA Through Week 100 (LOCF)|Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.|Baseline to Week 100|FAS|||percentage of participants|||Number
2644022|NCT01722045|Secondary|Percentage of Participants Who Gained ≥0, ≥5, ≥10, or ≥30 Letters From Baseline in BCVA Through Week 100 (LOCF)|Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.|Baseline to Week 100|FAS|||percentage of participants|||Number
2644023|NCT01722045|Secondary|Change From Baseline in Best Corrected Visual Acuity Score Through Week 52 (LOCF)|Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision.|Baseline to Week 52|FAS|||Letters correctly read||Standard Deviation|Mean
2644024|NCT01722045|Secondary|Percentage of Participants Who Gained ≥15 ETDRS Letters Compared With Baseline at Week 52 and Week 100 (LOCF)|Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. LOCF approach was used if any ETDRS letter score was missed after start of treatment, but baseline data were not carried forward. No formal statistical analyses were performed.|At week 52 and At week 100|FAS|||percentage of participants|||Number
2644025|NCT01722045|Secondary|"Percentage of Participants Whose Optical Coherence Tomography (OCT) Status Was Dry at Week 52 and at Week 100 (LOCF)"|Retinal fluid status was evaluated using spectral domain OCT on the study eye at every study visit. Last observation carried forward (LOCF) method was used to impute missing data.|Baseline to Week 100|Full analysis set (FAS)|||percentage of participants|||Number
2644026|NCT01722045|Primary|Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score From Baseline to Week 100 - Last Observation Carried Forward (LOCF)|Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. LOCF approach was used if any ETDRS letter score was missed after start of treatment, but baseline data were not carried forward. No formal statistical analyses were performed.|Baseline to Week 100|Results are presented for the full analysis set (FAS). FAS included all patients who received at least one dose of study drug in the study eye, had baseline Best Corrected Visual Acuity (BCVA) assessment on the study eye, and had at least one post-baseline BCVA assessment on the study eye.|||letters correctly read||Standard Deviation|Mean
2644027|NCT01721967|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ)|Kansas City Cardiomyopathy Questionnaire (KCCQ) (scores range from 0 to 100 with higher scores representative of a higher quality of life; clinically important changes are considered > 10 points and >5 points, respectively, as previously established|60 days post treatement||||units on a scale||Standard Deviation|Mean
2644028|NCT01721967|Secondary|Seattle Angina Questionnaire (SAQ)|The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life.|60 Days post treatment||||units on a scale||Standard Deviation|Mean
2644029|NCT01721967|Secondary|Improvement in Number of Episodes of Angina Per Week|Efficacy of ranolazine in HCM patients with respect to improvements in angina frequency (number of episodes of angina per week).|Baseline and 60 Days post treatment|episodes of angina per week was not collected||||||
2644030|NCT01721967|Primary|Drug Tolerability|Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose|60 days||||participants|||Number
2644031|NCT01721967|Primary|Number of Adverse Events Considered Probably or Possibly Related to Study Drug|Number of events that are considered probably or possibly related to study drug.|60 Days||||adverse event|||Number
2644032|NCT01721967|Primary|QT Interval||60 Days||||msec||Standard Deviation|Mean
2644033|NCT01721954|Secondary|Progression-free Survival|PFS defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as an increase in the sum of the longest diameters of ≥ 20% and an absolute increase in the sum of the longest diameters of ≥ 5 mm, or the appearance of a new lesion.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years 8 months.|ITT population|||months||95% Confidence Interval|Median
2644034|NCT01721954|Primary|Overall Survival (OS)|OS defined as the time interval between the date of randomization and the date of death from any cause.|From date of randomization until the date of death from any cause assessed up 3 yrs 8 months|ITT population|||months||95% Confidence Interval|Median
2644035|NCT01721837|Primary|Creatinine Clearance (Recalculated Using Entries of Age, Gender, Body Weight and Serum Creatinine Made by the Physician)|The creatinine clearance was recalculated with the Cockcroft-Gault formula using age, gender, body weight, and serum creatinine.|One single observation time point: at the time of prescription before the first intake of dabigatran etexilate|All patients with documented mild or moderate renal impairment and non-valvular atrial fibrillation (PPS) having evaluable data for age, gender, body weight, and serum creatinine. In 145 patients age, gender, serum creatinine or weight was missing so that Creatinine Clearance according to the Cockcroft Gault formula could not be recalculated.|||ml/min||Inter-Quartile Range|Median
2644036|NCT01721772|Secondary|Change From Baseline in Health-related Quality of Life (HRQoL) Scores|HRQoL is evaluated by mean changes from baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life composite scale in all randomized patients. The QLQ-30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicate better quality of life (QoL), while higher scores on the symptom scales indicate declining QoL.|At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 17 months|All participants randomized to receive treatment; n=number of participants evaluable|||Units on a scale||Standard Deviation|Mean
2644037|NCT01721772|Primary|Overall Survival (OS) Rate|OS rate is calculated as the percentage of participants who have not died divided by the total number of participants in the arm, based on Kaplan-Meier estimates|Randomization to 6 months and 12 months|All participants randomized to receive treatment|||Percentage of participants||95% Confidence Interval|Number
2644038|NCT01721772|Other Pre-specified|Number of Participants Who Died and With Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Drug-related AEs Leading to Discontinuation, and Drug-related AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or unknown relationship to study drug.|Day of first dose to day of final dose + 30 days, assessed up go 17 months|All participants who received at least 1 dose of study drug|||Participants|||Number
2644039|NCT01721772|Secondary|Overall Survival by Programmed Cell Death Ligand 1 (PD-L1) Expression Level|Overall Survival by PD-L1 expression level, which was defined as the percent of tumor cells demonstrating plasma membrane PD-L1-staining in a minimum of 100 evaluable tumor cells per a Dako PD-L1 IHC assay (referred to as quantifiable PD-L1 expression). Assessment of OS by PD-L1 expression as measured by a validated assay and comparing OS in patients with tumor PD-L1 expression ≥5% versus patients with tumor PD-L1 expression <5%. Tumor tissue samples for PD-L1 testing were collected at screening from metastatic or unresectable sites prior to randomization.|From date of randomization to date of disease progression or death, as assessed to 17 months|All participants randomized to receive treatment|||Months||95% Confidence Interval|Median
2644058|NCT01721603|Secondary|Systemic Overall Response Rate|"Determine the systemic best overall response rate of BRAFV600E melanoma brain metastasis patients treated with SRS, trametinib and dabrafenib.~The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).~The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented."|From surgery up to 12 months||||Participants|||Count of Participants
2644096|NCT01721317|Secondary|Change From Baseline in Hematocrit|The change from Baseline in the indicated hematology test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
2644040|NCT01721772|Secondary|Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST)|ORR is defined as the percentage of participants with a best overall response of RECIST-defined complete response (CR) or partial response (PR) divided by the number of randomized participants in each treatment arm. RECIST, volume 1.1 for target lesions: CR=disappearance of all target lesions; PR=at least a 30% decrease in the sum of the longest dimension (LD) of target lesions, taking as reference the baseline sum LD; stable disease=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD=at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, and the sum LD must have an absolute increase of ≥5 mm.|Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 17 months|All participants randomized to receive treatment|||Percentage of participants||95% Confidence Interval|Number
2644041|NCT01721772|Secondary|Progression-free Survival (PFS) Rate|The PFS rate at a time point is the estimated percentage of patients who have not progressed and are alive at that time point following randomization and is estimated using the Kaplan-Meier methodology.|Tumor assessments beginning at 9 weeks following randomization and continuing every 6 weeks for the first year, then every 12 weeks thereafter until disease progression or death, assessed to 17 months|All participants randomized to receive treatment|||Percentage of participants||95% Confidence Interval|Number
2644042|NCT01721772|Secondary|Progression-free Survival (PFS)|Investigator-assessed PFS is defined as the time from randomization to the date of the first documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Patients who died without progressing were considered to have progressed on the date of their death. Those who did not progress or die were censored on the date of their last evaluable tumor assessment. Patients who did not have any on-study tumor assessments and did not die were censored on their date of randomization. Those who started any subsequent anticancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to initiation of subsequent anticancer therapy.|From date of randomization to date of disease progression or death, assessed to 17 months|All participants randomized to receive treatment|||Months||95% Confidence Interval|Median
2644043|NCT01721772|Primary|Overall Survival (OS)|OS is defined as the time between the date of randomization and the date of death. For those without documentation of death, OS will be censored on the last date the participant was known to be alive.|From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed to 17 months.|All participants randomized to receive treatment|||Months||95% Confidence Interval|Median
2644044|NCT01721759|Primary|Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC)|"ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment.~Participants were evaluated for tumor response per RECIST v1.1 for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method."|Day 1 of treatment to approximately 16 months|Participants who received at least 1 dose of study drug|||Percentage of participants||95% Confidence Interval|Number
2644045|NCT01721759|Secondary|Objective Response Rate (ORR) as Assessed by Investigator|"ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the total number of participants who received treatment.~Participants were evaluated for tumor response per RECIST v1.1 for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~Best overall response, ORR, duration of response, and time to response as assessed by investigator were summarized using RECIST v1.1, to confirm response."|Day 1 of treatment to approximately 16 months|Participants who received at least 1 dose of study drug|||Percentage of participants||95% Confidence Interval|Number
2644046|NCT01721759|Primary|Objective Response Rate (ORR) as Assessed by Independent Radiology Review Committee (IRC)|"ORR is defined as the number of participants with best overall response (OR) of confirmed complete response (CR) or partial response (PR) divided by the number of participants who received treatment.~Participants were evaluated for tumor response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.~The IRC-assessed ORR (using RECIST v1.1, to confirm response and based on the IRC global radiology review after incorporation of on-study clinical data) was estimated using a binomial response rate and its corresponding 2-sided 95% exact confidence intervals using the Clopper-Pearson method."|Day 1 of treatment to approximately 19 months|Participants who received at least 1 dose of study drug|||Percentage of participants||95% Confidence Interval|Number
2644047|NCT01721746|Secondary|Mean Change From Baseline in Health-related Quality of Life (HRQoL) Global Health Status Scores|Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument's 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric. Higher scores for all functional scales and Global Health Status=better HRQoL; an increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL; a decline from baseline for symptom scales =improvement in symptoms compared to baseline. A 10 point difference on a 100 point scale between treatments was considered clinically significant.|From Baseline (Day1) to second Follow-Up; up to 37 months|All randomized participants with a baseline measurement and at least one on-study assessment; n=number of participants evaluable|||units on a scale||Standard Deviation|Mean
2644048|NCT01721746|Secondary|Median Overall Survival (OS) Time in Months by Baseline PD-L1 Expression|"PD-L1 expression evaluated as a predictive biomarker for OS by analyzing the interaction between PD-L1 expression and treatment arms. Randomized participants with an Indeterminate PD-L1 result per the verified assay were categorized as Subjects without Tumor Tissue Samples. Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. OS was followed continuously while participants were on the study drug and every 3 months via in-person or phone contact after participants discontinued the study drug. The interim OS analysis was performed on all randomized subjects when at least 169 events had been observed. Analysis made at Primary Endpoint; Study On-going."|From the date of randomization to the date of death; up to 37 months|All PD-L1 Evaluable Participants; Randomized participants among the OS population who had a tumor biopsy specimen assessed for PD-L1 expression with the validated assay and for which quantifiable tumor PD-L1 levels were discernible.|||months||95% Confidence Interval|Median
2644049|NCT01721746|Secondary|Objective Response Rate (ORR) by Baseline PD-L1 Expression|"PD-L1 expression evaluated as a predictive biomarker for ORR by analyzing the interaction between PD-L1 expression and treatment arms. Randomized participants with an Indeterminate PD-L1 result per the verified assay were categorized as Subjects without Tumor Tissue Samples. ORR=number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants and reported as a percentage. Analysis made at Primary Endpoint; Study On-going."|From date of randomization to the date of objectively documented progression or the date of subsequent therapy; approx. 16 months|All PD-L1 Evaluable Participants; Randomized participants among the ORR population who had a tumor biopsy specimen assessed for PD-L1 expression with the validated assay and for which quantifiable tumor PD-L1 levels were discernible.|||percentage of participants||95% Confidence Interval|Number
2644050|NCT01721746|Secondary|Median Months of Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRC/IRRC)|PFS=time from randomization to the date of the first documented progression or death due to any cause, whichever first. Participants who (1) died without a reported progression were considered to have progressed on the date of their death, (2) did not progress or die were censored on the date of their last evaluable tumor assessment, (3) did not have any on study tumor assessments and did not die were censored on the date they were randomized, and (4) started any subsequent anti-cancer therapy (including tumor-directed radiotherapy or surgery) without a prior reported progression were censored at the last evaluable tumor assessment prior to or upon initiation of the subsequent anti-cancer therapy. Per RECIST 1.1, progression is >= 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (includes baseline sum if smallest on study). The sum must demonstrate an absolute increase of >= 5 mm. Analysis made at Primary Endpoint; Study On-going|From the date of randomization to the date of the first documented progression or death; up to 37 months|All Randomized Participants: All participants randomized to any treatment group|||months||95% Confidence Interval|Number
2644051|NCT01721746|Primary|Median Overall Survival (OS) at Primary Endpoint|Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. OS was followed continuously while participants were on the study drug and every 3 months via in-person or phone contact after participants discontinued the study drug. This interim OS analysis was performed on all randomized subjects when at least 169 events had been observed. Analysis made at Primary Endpoint; Study On-going.|From the date of randomization to the date of death; up to 37 months|All Randomized Participants: All participants randomized to any treatment group|||months||95% Confidence Interval|Number
2644052|NCT01721746|Primary|Objective Response Rate (ORR)|ORR=number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants and reported as a percentage. BOR was defined as the best response designation, as determined by the independent review committee (IRC), recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurred first. For participants without documented progression or subsequent therapy, all available response designations contributed to the BOR assessment. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Analysis made at Primary Endpoint; Study On-going|From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy; approx. 16 months|All Randomized Participants: All participants randomized to any treatment group|||percentage of participants||95% Confidence Interval|Number
2644053|NCT01721681|Secondary|Pharmacokinetics: FX:C Incremental Recovery|One of the secondary objectives was to assess the pharmacokinetics (FX:C incremental recovery 30 minute post-dose at the Visit 1 (Baseline) and the End of Study Visit after a single dose of 50 IU/kg). The overall mean IR calculated for both visits is presented in the outcome measure table.|Baseline Visit and End of Study Visit, 30 minutes post-dose|Plasma concentrations were obtained for FX:C for all 9 subjects at 30 minutes post dose at Visit 1 and Visit 5.|||IU/dL||95% Confidence Interval|Mean
2644054|NCT01721681|Secondary|Safety of FACTOR X: Number of Participants Experiencing Adverse Events|One of the secondary objectives was to assess the safety of FACTOR X when given as routine prophylaxis over 6 months (26 weeks). The general strategy of the safety evaluation was to examine the summaries for any trends. No formal hypothesis was carried out. The number of participants who experienced Adverse Events is provided.|6 months|The safety evaluation examined the summaries for any trends. No formal hypothesis was carried out.|||Participants|||Count of Participants
2644055|NCT01721681|Primary|The Number of Participants With Excellent Reduction in Bleeding When Given FACTOR X as Routine Prophylaxis Over 6 Months|"The Investigator's assessment of the efficacy of FACTOR X in reduction/prevention of bleeding when given as routine prophylaxis over 6 months.~The efficacy was assessed according to tabulated criteria; Excellent, good, poor, unassessable."|6 months||||Participants|||Count of Participants
2644056|NCT01721603|Secondary|Median Overall Survival|Determine the median overall survival of BRAFV600E melanoma brain metastasis patients treated with SRS, trametinib and dabrafenib.|From surgery up to 12 months|Study was terminated due to low accrual. Secondary outcome measure was not accessed.||||||
2644059|NCT01721603|Secondary|Median Time to Progression|Determine the median time to progression in the brain of BRAFV600E melanoma brain metastases patients treated with SRS, trametinib and dabrafenib. RECIST v1.1 will be used as the primary determinant of disease progression. Disease response will be assessed at scheduled visits by MRI of the brain and clinical exam every two months thereafter. The proportion of patients that progression free at 6 months will be calculated.|From surgery up to 12 months|Study was terminated due to low accrual. Secondary outcome measure was not accessed.||||||
2644060|NCT01721603|Secondary|Median Duration of Freedom From New Brain Metastases( by RECIST v1.1 )|Determine median duration of freedom from new brain metastases of BRAFV600E melanoma brain metastases patients treated with SRS, trametinib and dabrafenib. RECIST v1.1 will be used as the primary determinant of disease progression.|From surgery up to 12 months|Study was terminated due to low accrual. Secondary outcome measure was not accessed.||||||
2644061|NCT01721603|Secondary|Best Overall Response Rate (by RECIST v1.1 )|Determine the best overall response rate (by RECIST v1.1 ).|From surgery up to 12 months||||Participants|||Count of Participants
2644062|NCT01721603|Secondary|Patients Displaying 6-month Local Control Rate|Determine whether dabrafenib combined with SRS and trametinib improves the 6-month local control rate of BRAFV600E melanoma brain metastases compared with historical controls treated with SRS.|From surgery up to 6 months||||Participants|||Count of Participants
2644063|NCT01721603|Primary|Patients Reaching 6 Month Distant Brain Metastasis-free Survival (DBMFS)|Determine whether dabrafenib combined with stereotactic radiosurgery (SRS) and trametinib improves the 6 month DBMFS rate of BRAFV600E melanoma patients for whom the standard of care is stereotactic radiosurgery (≤4 brain lesions and no lesion > 3 cm) in comparison with similar historical controls treated with radiosurgery alone.|Up to 6 months after surgery||||Participants|||Count of Participants
2644064|NCT01721564|Secondary|Intravascular Ultrasound - Pulmonary Artery Wall Thickness|Change in intima-media thickness|baseline and 6 months||||percentage of baseline||Standard Deviation|Mean
2644065|NCT01721564|Primary|Acetylcholine Vascular Reactivity Response|Percent pulmonary flow change from baseline after acetylcholine|Baseline and 6 months||||percentage of baseline||Standard Deviation|Mean
2644066|NCT01721486|Secondary|Parental Satisfaction With Pain Control.|Parental satisfaction with pain control, as measured on a 10 point Likert scale where 1= Extremely dissatisfied and 10= Extremely satisfied. Data gathered through phone call to parents 24 hours post hospital discharge.|24 hours post hospital discharge.||||units on a scale||Inter-Quartile Range|Median
2644067|NCT01721486|Secondary|Incidence of Post-operative Vomiting|Percentage of subjects with at least one episode of post-operative vomiting|From admission into PACU until 24 hours post-hospital discharge. At the conclusion of enrollment, this measure will be assessed for all participants.||||Participants|||Count of Participants
2644068|NCT01721486|Secondary|FLACC: Face, Legs, Activity, Cry & Consolability (FLACC) Pain Assessment Scores|FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures each of 5 pain behaviors on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.|At time of admission into PACU.||||units on a scale||Full Range|Median
2644069|NCT01721486|Primary|Total Pain Medication|All pain medication documented during the first 24 hours postoperatively, in mg morphine equivalents.|From time of PACU admission until 24 hours post-operatively.|Only patients receiving rescue pain medication were analyzed.|||mg||Inter-Quartile Range|Median
2644070|NCT01721473|Primary|PET Scan, Rating Scales|Vt/fp values (indicating relative densities of alpha4beta2 nicotinic acetylcholine receptors in different brain regions) in various brain regions - can also be referred to as mL/cm3.|Primary outcome measures will be determined over approximately 3 weeks|Non-smokers and smokers (with the set of different conditions: menthol, non-menthol, w/ caffeine, w/ marijuana, w/o caffeine+marijuana) who underwent PET scanning to measure the total volume of distribution Vt in the prefrontal cortex.|||Vt/fp or mL/cm3||Standard Deviation|Mean
2644071|NCT01721460|Secondary|Portion of Participants With Timely Return of the Neuronal Activity to Baseline|The portion of patients in which neuronal activity returned to baseline within 30 after stopping sedation.|30 minutes after stopping drug administration|All participants that received sedation. As the activity did not return to baseline within the allocated time for the study (30 minutes), we report the portion of patients in which the activity returned to baseline within this time.|||Participants|||Count of Participants
2644072|NCT01721460|Secondary|Time to Recovery|The time it takes for the patient to become alert after drug administration is stopped.|20-60 minutes after stopping drug administration|All participants that received sedation.|||minutes||Standard Deviation|Mean
2644073|NCT01721460|Secondary|Change in Average Firing Pattern in the STN|We've used total power in the Beta range (13-30Hz) to evaluate change in firing pattern and oscillation frequency.|20-35 minutes following drug administration|All participants that received sedation|||percentage change||Standard Error|Mean
2644074|NCT01721460|Primary|Change in Average Population Spiking Activity|"We calculated the root mean square (RMS) of the high frequency electrical activity. This is a common measure for the spiking rate of the population of neurons in the vicinity of the electrode tip. This Measure has been previously described as a useful measure to determine the target location during deep brain stimulation (DBS) procedures. We calculated the change in RMS inside the STN between baseline and peak sedation.~For each subject we normalized the RMS to the RMS of the electrical activity outside the nucleus. This is done to eliminate the effects of noise and variability in electrode resistance. Thus, the normalized RMS is a pure number with no units."|20-35 minutes following drug administration|All participants had the normalized RMS of the electrical activity calculated during control period, and under maximal sedation, and the difference between the two was calculated and normalized.|||Percent change||Standard Deviation|Mean
2644075|NCT01721447|Secondary|Concordance Between Echo Readers in Determining Presence or Absence of Thrombus in the Left Atrial Appendage|Percent agreement between echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent|One transesophageal echocardiography, up to 1 hour||||Percentage of Agreement|||Number
2644076|NCT01721447|Primary|Percent Confidence in Assessment of Left Atrial Appendage Thrombus|Confidence among echo readers to determine presence or absence of left atrial appendage thrombus before and after injection of Optison contrast agent. Percent confidence was calculated from a subjective assessment made by each reader after viewing the echo images. A six-point scale was used by the readers to grade the subjective assessment of their confidence in detecting thrombus; a score of 0 representing 0% (no confidence) up to a score of 5 representing 100% (total confidence) that the interpretation was correct for presence or absence of left atrial appendage thrombus. The reported percent confidence is the average of both echo readers.|One Transesophageal Echocardiography, up to 1 hour||||Percentage of Confidence||Standard Deviation|Mean
2644077|NCT01721408|Primary|Clinical Response at the TOC Assessment Within the Modified Intent-to-Treat (mITT) Population|The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).|Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)|The MITT population was defined as all randomized participants who received at least 1 dose of investigational product.|||percentage of participants||95% Confidence Interval|Number
2644078|NCT01721408|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) by Relationship and Seriousness|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs.|From the first dose of study treatment through post therapy follow-up (28 days after the last dose of therapy)|Safety population included all participants who received at least 1 dose of investigational product. There was 1 participant (who was included in the safety population) had 7 AEs including 1 SAE which were identified after database release and were not reflected in the table.|||participants|||Number
2644079|NCT01721408|Secondary|Microbiological Response at the Subject Level in the ME Population at the TOC Assessment|The microbiological response at the subject level was described according to the following definitions of efficacy. Eradication (documented or presumed): none of the baseline pathogens were present in repeat intra-abdominal cultures from the original site of infection taken during the study or a clinical response of cure precluded the necessity of a repeat intra-abdominal culture. Persistence (documented or presumed): documented: any baseline intra-abdominal pathogen was present in the cultures obtained from the original site of the intra-abdominal abscess, peritonitis, or surgical wound infection during the study; Presumed: repeat microbiological data were not obtained for a participant with a clinical response of failure. Superinfection: Emergence of a new pathogen during therapy, at the site of infection with emergence or worsening of clinical signs and symptoms of infection.|Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)|The ME population was defined as all CE participants who satisfied the pre-specified ME evaluable criteria. n=number of participants with each microbiological response.|||percentage of participants||95% Confidence Interval|Number
2644080|NCT01721408|Secondary|Clinical Response at the TOC Assessment Within the Microbiologically Evaluable (ME) Population|The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).|Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)|The ME population was defined as all CE participants who satisfied the pre-specified ME evaluable criteria.|||percentage of participants||95% Confidence Interval|Number
2644081|NCT01721408|Primary|Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population|The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons).|Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy)|The CE population was defined as all clinical modified intent-to-treat (c-mITT) participants who satisfied clinical evaluability criteria and had no major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2660063|NCT01584388|Secondary|Sustained Disease Response|Decline of the IgG4-RD RI by at least two points and maintained for 12 months.|12 months||||Participants|||Count of Participants
2644082|NCT01721330|Primary|Change in Adult Investigator Symptom Rating Scale (AISRS) Score|The AISRS is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). We measured the change in AISRS score from baseline to week 6.|6 weeks|One subject withdrew from the study before receiving study medication, so data from only two subjects was analyzed (one subject in each group). Therefore, means and standard deviations were not calculated.|||units on a scale|||Number
2644083|NCT01721317|Secondary|Number of Participants With the Indicated Assessment Events of Suicidal Behavior, Suicidal Ideation or Non-suicidal Self Injurious Behavior Via the Columbia Suicide Severity Rating Scale (C-SSRS)|Prospective assessment of suicidality was conducted using the Columbia-Suicide Severity Rating Scale (C-SSRS), a brief questionnaire designed to assess severity and change in suicidality by integrating both behavior and ideation using a semi-structured interview to probe participant responses. C-SSRS data were only collected through Week 8 for the 6 randomized participants. Due to the study being prematurely terminated, there was not sufficient data to evaluate this endpoint.|Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 4, Week 6 and Week 8|Safety Population|||Participants|||Number
2644084|NCT01721317|Secondary|Change From Baseline in Post-void Residual (PVR) Urinary Bladder Ultrasound Volume|The change from Baseline in the PVR bladder ultrasound results was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase) and Week 18 (end of Maintenance Phase)|Safety Population||||||
2644085|NCT01721317|Secondary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick|The change from Baseline in the following urinalysis parameters (urine occult blood, urine glucose, urine ketones and urine protein) were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
2644086|NCT01721317|Secondary|Change From Baseline in Urine Potential of Hydrogen (pH)|The change from Baseline in the indicated urinalysis test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize ot evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
2644087|NCT01721317|Secondary|Change From Baseline in Urine Specific Gravity (USG)|The change from Baseline in the indicated urinalysis test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
2644088|NCT01721317|Secondary|Change From Baseline in Creatinine Clearance|The change from Baseline in the indicated chemistry test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
2644089|NCT01721317|Secondary|Change From Baseline in BUN/Creatinine Ratio|The change from Baseline in the indicated chemistry tests was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
2644090|NCT01721317|Secondary|Change From Baseline in Calcium, Chloride, Potassium, Sodium, Glucose, Magnesium, Phosphorus Inorganic, Bicarbonate and Urea/Blood Urea Nitrogen (BUN)|The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
2644091|NCT01721317|Secondary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Uric Acid and Creatinine|The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
2644092|NCT01721317|Secondary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Lactate Dehydrogenase and Gamma Glutamyltransferase (GGT)|The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
2644093|NCT01721317|Secondary|Change From Baseline in Albumin and Total Protein|The change from Baseline in the indicated chemistry tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
2644094|NCT01721317|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin|The change from Baseline in the indicated hematology test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
2644095|NCT01721317|Secondary|Change From Baseline in Red Blood Cell (RBC) Count|The change from Baseline in the indicated hematology test was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
2660064|NCT01584388|Secondary|Disease Response at 6 Months|Decline of IgG4-RD Responder Index by at least two points for at least 6 months|6 months||||Participants|||Count of Participants
2644097|NCT01721317|Secondary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration|The change from Baseline in the indicated hematology tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
2644098|NCT01721317|Secondary|Change From Baseline in the Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Segmented Neutrophils, White Blood Cell (WBC) Count and Platelet Count|The change from Baseline in the indicated hematology tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
2644099|NCT01721317|Secondary|Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Segmented Neutrophils and Red Blood Cell (RBC) Distribution Width|The change from Baseline in the indicated hematology tests were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
2644100|NCT01721317|Secondary|Change From Baseline in the QT Interval Using Bazett's Correction (QTcB) and QT Interval Using Fridericia's Correction (QTcF)|Change from Baseline in the QT interval using Bazett's correction (QTcB) and QT interval using Fridericia's correction were to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
2644101|NCT01721317|Secondary|Change From Baseline in Heart Rate|Change from Baseline in heart rate was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
2644102|NCT01721317|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Change from Baseline in blood pressure was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
2644103|NCT01721317|Secondary|Change From Baseline in Body Weight|Change from Baseline in body weight was to be assessed. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Screening, Week 0 (end of Baseline Phase), Week 2 (end of Titration Phase), Week 10 (end of Dose-Optimization Phase), Week 18 (end of Maintenance Phase) and Week 21 (end of Taper Phase)|Safety Population||||||
2644104|NCT01721317|Secondary|Number of Participants With Early Study Discontinuation|The safety and tolerability of ezogabine/retigabine IR was to be evaluated by recording the incidence of participants with early study discontinuation.|Week 0 (end of Baseline Phase) to Week 21 (end of Taper Phase)|Safety Population|||Participants|||Number
2644105|NCT01721317|Secondary|Number of Participants at Each Dose During the Maintenance Phase and Average Maintenance Dose Over All Participants|The safety and tolerability of ezogabine/retigabine IR was to be evaluated by recording the number of participants at each dose during the Maintenance Phase and the average maintenance dose over all participants. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 11 (start of Maintenance Phase) to Week 18 (end of Maintenance Phase)|Safety Population||||||
2644106|NCT01721317|Secondary|Incidence of New Seizure Types in Participants Without a History of These Seizure Types|The safety and tolerability of ezogabine/retigabine IR was to be evaluated by recording the incidence of new seizure types in participants without a history of these seizure types. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) to Week 21 (end of Taper Phase)|Safety Population: all randomized participants who receive >= 1 dose of study medication.||||||
2644107|NCT01721317|Secondary|Percent Change From Baseline in Functional Status (Epilepsy-related Worry and Activity Limitation) and Productivity (Missed Work or School) to the End of the Dose-Optimization Phase and the End of the Maintenance Phase|The effect of ezogabine/retigabine IR as an adjunctive treatment on health outcomes was to be evaluated on the basis of functional status and productivity. Participants were asked to complete the paper functional status diary to collect information to assess how the participant's functional status is affected by their epilepsy symptoms. Participants were asked to rate their epilepsy-related worry, activity limitations, and productivity (missed work or school). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 3 (start of Dose -Optimization Phase) to Week 18 (end of Maintenance Phase)|ITT Population||||||
2644108|NCT01721317|Secondary|Change From Baseline in the Number of Seizure Free Days for the Indicated Intervals: Double-blind Period (Titration Phase + Dose-Optimization Phase + Maintenance Phase), Maintenance Phase and the Dose-Optimization + Maintenance Phase|The change in number of seizure free days during the Double-Blind period, the Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase were to be reported. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) to Week 18 (end of Maintenance Phase)|ITT Population||||||
2644109|NCT01721317|Secondary|Number of Seizure Free Participants for the Indicated Intervals: Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase|Participants without seizures during the interval of Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase were to be reported. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 3 (start of Dose-Optimization Phase) to Week 18 (end of Maintenance Phase)|ITT Population||||||
2646317|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Symptom Free Days||Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)|Full Analysis set|||symptom free days||90% Confidence Interval|Least Squares Mean
2644110|NCT01721317|Secondary|Number of Par. Experiencing >=50% Reduction in 28-day Total Partial Seizure Frequency (POS) for the Intervals: Double-blind Period (Titration Phase + Dose-Optimization Phase + Maintenance Phase), Maintenance Phase and Dose-Optimization + Maintenance Phase|Participants (par.) experiencing >= 50% reduction from Baseline to the end of the Double-Blind Phase in 28-day total POS were to be reported. Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) through Week 18 (end of Maintenance Phase)|ITT Population||||||
2644111|NCT01721317|Secondary|Percent Change in 28-day Total Partial Seizure Frequency (POS) for the Indicated Intervals: Maintenance Phase and the Dose-Optimization Phase + Maintenance Phase|The efficacy of ezogabine/retigabine IR as an adjunctive treatment was to be evaluated by the percent change in total partial seizure frequency during the Dose-Optimization Phase and Maintenance Phase. The total 28-day POS value is defined as the total number of POS reported during the evaluation period divided by the total number of applicable days during the evaluation period with this quotient multiplied by 28 days. The applicable days are the days in which the participant had non-missing seizure data (i.e., either 0 or > 0 seizures recorded). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 3 (start of Dose -Optimization Phase) to Week 18 (end of Maintenance Phase)|ITT Population||||||
2644112|NCT01721317|Primary|Percent Change in the 28-day Total Partial Seizure Frequency (POS) Within Each Stratum From Week 0 (End of Baseline Phase) Through Week 18 (End of Maintenance Phase)|The percent change in 28-day total POS frequency within each stratum (sodium channel blocker or non-sodium channel blocker) background antiepileptic drug (AED) was to be summarized as the supportive analysis. The total 28-day POS value is defined as the total number of POS reported during the evaluation period divided by the total number of applicable days during the evaluation period with this quotient multiplied by 28 days. The applicable days are the days in which the participant had non-missing seizure data (i.e., either 0 or > 0 seizures recorded). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) through Week 18 (end of Maintenance Phase)|ITT Population||||||
2644113|NCT01721317|Primary|Percent Change in the 28-day Total Partial Seizure Frequency (POS) From Week 0 (End of Baseline Phase) Through Week 18 (End of Maintenance Phase)|The efficacy of ezogabine/retigabine IR as an adjunctive treatment was to be evaluated by the percent change in the total partial seizure frequency, which was recorded by participants in the daily seizure calendar. The total 28-day POS rate is defined as the total number of POS reported during the evaluation period divided by the total number of applicable days during the evaluation period with this quotient multiplied by 28 days. The applicable days are the days in which the participant had non-missing seizure data (i.e., either 0 or > 0 seizures recorded). Due to the study being prematurely terminated, there was not sufficient data to summarize or evaluate this endpoint.|Week 0 (end of Baseline Phase) through Week 18 (end of Maintenance Phase)|Intent-to-Treat (ITT) Population: all randomized participants who received >= 1 dose of study medication and who had >= 1 post-Baseline seizure diary day with >= 0 seizures recorded.||||||
2644114|NCT01721226|Secondary|Linkage to Community Care|At least 1 visit to health care provider in past 24 weeks/6 months|24 weeks||||Participants|||Count of Participants
2644115|NCT01721226|Primary|Plasma Viral Load Suppression|Plasma viral load at 24 weeks measured by viral load testing or medical chart abstraction|24 weeks|All study participants with available PVL data|||participants|||Number
2644116|NCT01721200|Secondary|Changes in Perceived Knowledge|Perceived knowledge and value clarity will be measured using two subscales from the well-validated Decisional Conflict Scale (66). Each subscale is composed of 3 items measured on 5-point agree scales. Scores are rescaled to range from 0 to 100. Higher scores reflect greater conflict (poorer outcomes).|8 weeks||||units on a scale||Inter-Quartile Range|Median
2644117|NCT01721200|Secondary|Changes in Willingness|"Willingness: Patients' propensity towards biologics will be measured using the choice predisposition scale (65): This item is coded on a 11-point scale anchored by Not willing at all and Extremely willing with Unsure at the midpoint (65). Higher scores reflect greater willingness."|8 weeks|Follow-up data not collected because of ceiling effect.||||||
2644118|NCT01721200|Secondary|Changes in Knowledge|Knowledge will be measured using the 20 True/False statements developed for the initial pre-post test study. The number of correct responses are summed to yield a knowledge score (possible range= 0-20). The item order was determined using a random-numbers generator.|8 weeks||||units on a scale||Inter-Quartile Range|Median
2644119|NCT01721200|Secondary|To Test Adherence to the Intervention|The session management system will record the time spent on each module visited within the tool to assess adherence.|8 weeks|These data were not collected.||||||
2644120|NCT01721200|Secondary|Acceptability to Physicians|"Acceptability to physicians will be assessed using four items coded on 5-point Frequency scales (1= None of the time and 5= All of the time) administered by the research assistant once all patient follow-up interviews have been completed:~Did the tool make it easier to talk about treatment with your patients?~Did the tool increase the amount of time you spent discussing therapy with your patients?~Did the tool decrease the amount of time you spent discussing therapy with your patients?~Did the tool improve the quality of informed consent for patients initiating biologics?"|8 weeks|Data not collected||||||
2644121|NCT01721200|Secondary|To Test Uptake|To test uptake and adherence to the intervention we will measure the proportion of patients randomized to the intervention who access the tool, complete the Best Worse Scaling exercise, print a handout, and use the handout during a follow-up visit with their rheumatologist (for subjects having a second visit within eight weeks). Note, subjects without access to a printer will have the opportunity to do so in the office.|8 weeks|Data not collected||||||
2644122|NCT01721200|Secondary|To Test Screening and Recruitment Procedures|To test screening and recruitment procedures we will measure the number of eligible patients, the number of patients excluded by each exclusion criterion, the number of patients referred by rheumatologists each week, and the proportion of patients who agree to participate.|8 weeks|Data not collected||||||
2644123|NCT01721200|Secondary|Use of Biologics|Use of biologics: The number of patients received a prescription for a new biologic by eight weeks.|8 weeks||||Number of subjects|||Number
2646318|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Symptom Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)|Full Analysis set|||symptom free days||90% Confidence Interval|Least Squares Mean
2644124|NCT01721200|Secondary|Patient-physician Communication|Patient-physician communication will be measured using the COMRADE (Combined Outcome Measure for Risk communication And treatment Decision making Effectiveness): a 20-item scale composed of two subscales which address the quality of risk communication (process measure) and the quality of the decision making process (outcome measure). Items are measured on a 5-point agree scales. The COMRADE is a includes two sub-scales (each composed of 10 items): one for risk communication (a process measure) and a second for confidence in decision (an outcome measure). Subscales are summed to generate a total score (Range 20-100). Higher scores reflect poorer outcomes.|8 weeks||||units on a scale||Standard Deviation|Mean
2644125|NCT01721200|Primary|The Proportion of Subjects Who Are Classified as Having Made an Informed Value Concordant Choice at 2 Weeks|We classified subjects as having made an informed choice to escalate care if they answered at least 75% of the knowledge questions correctly and had low decisional conflict as defined by a score of 25 or lower on the combined subjective knowledge and values clarity subscales.|2 weeks||||Percentage of subjects|||Number
2644126|NCT01721161|Secondary|Summary of BIIB033 Concentration|One pre-dose pharmacokinetic (PK) sample and 1 post-dose PK sample (approximately between 1 and 3 hours after the end of IV infusion) were collected for all participants on Day 1 and at Weeks 4 through 20 (every 4 weeks). Additionally, only 1 PK sample was collected at Week 24 and Week 32. (There was no dosing on Week 24 and Week 32, so only one blood sample for BIIB033 concentration was taken.) Samples collected at early termination visits were treated as predose samples for the next scheduled visit.|Up to 32 weeks|PK analysis population: all participants who received at least 1 dose of BIIB033 and had at least 1 serum concentration data on record. n=number of participants with a sample at given timepoint.|||µg/mL||Full Range|Median
2644127|NCT01721161|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the subject at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the subject or may have required intervention to prevent one of the other outcomes listed in the definition above.|32 weeks|Safety population: all participants who received at least 1 dose of study treatment.|||participants|||Number
2644128|NCT01721161|Primary|Change in FF-VEP Latency at Week 24: Per-protocol Population|Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.|Baseline, Week 24|Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive multiple sclerosis (MS)-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.|||msec||Standard Error|Mean
2644129|NCT01721161|Secondary|Change in LCLA at Week 24: Per-protocol Population|Adjusted mean change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value. The fellow eye is the reference eye for the inter-eye asymmetry. The range for LCLA assessment is 0-60.|Baseline, Week 24|Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.|||letters on a chart||Standard Error|Mean
2644130|NCT01721161|Secondary|Change in Low-contrast Letter Acuity (LCLA) at Week 24: ITT Population|Adjusted mean change in LCLA at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts, adjusted for the baseline LCLA value. The fellow eye is the reference eye for the inter-eye asymmetry. The range for LCLA assessment is 0-60.|Baseline, Week 24|ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) with an LCLA assessment at Baseline. LOCF imputation was used if Week 24 data were missing.|||letters on a chart||Standard Deviation|Mean
2644131|NCT01721161|Secondary|Change in SD-OCT Average RGCL/IPL at Week 24: Per-protocol Population|Adjusted mean change in thicknesses of the RGCL/IPL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. Adjusted for the baseline RGCL/IPL thickness.|Baseline, Week 24|Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.|||µm||Standard Deviation|Mean
2644132|NCT01721161|Secondary|Change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) at Week 24: ITT Population|Adjusted mean change in thicknesses of the RGCL/IPL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. Adjusted for the baseline RGCL/IPL thickness.|Baseline, Week 24|ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) with a valid RGCL/IPL assessment at Baseline. LOCF imputation was used if Week 24 data were missing.|||µm||Standard Deviation|Mean
2644133|NCT01721161|Secondary|Percentage Change in SD-OCT Average RNFL Thickness at Week 24: Per-protocol Population|Adjusted mean percentage change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by SD-OCT. Percentage change is calculated as (affected eye - baseline of fellow eye)/baseline of fellow eye*100. Adjusted for the baseline RNFL thickness.|Baseline, Week 24|Per-protocol Population: participants from the ITT population who completed the study, did not miss more than 1 dose of BIIB033 or placebo, and did not receive MS-modifying therapies during the study period, which were prohibited per protocol. LOCF imputation was used if Week 24 data were missing.|||percentage change||Standard Error|Mean
2644168|NCT01721096|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)|3 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644134|NCT01721161|Secondary|Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at Week 24: ITT Population|Adjusted mean percentage change in thickness of the RNFL at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by SD-OCT. Percentage change is calculated as (affected eye - baseline of fellow eye)/baseline of fellow eye*100. Adjusted for the baseline RNFL thickness.|Baseline, Week 24|ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo) and a valid RNFL assessment at Baseline. LOCF imputation was used if Week 24 data were missing.|||percentage change||Standard Error|Mean
2644135|NCT01721161|Primary|Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population|Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.|Baseline, Week 24|ITT population: all randomized subjects who received at least 1 dose of study treatment (BIIB033 or placebo). Last observation carried forward (LOCF) imputation was used if Week 24 data were missing.|||msec||Standard Error|Mean
2644136|NCT01721109|Secondary|Change From Baseline in CD4 Percentage at Weeks 24 and 48||Baseline; Weeks 24 and 48|Participants in the Full Analysis Set with available data were analyzed.|||percentage||Standard Deviation|Mean
2644137|NCT01721109|Secondary|Change From Baseline in CD4+ Cell Count at Weeks 24 and 48||Baseline; Weeks 24 and 48|Participants in the Full Analysis Set with available data were analyzed.|||cells/µL||Standard Deviation|Mean
2644138|NCT01721109|Secondary|Change From Baseline in Plasma log10 HIV-1 RNA at Weeks 24 and 48||Baseline; Weeks 24 and 48|Full Analysis Set: all participants who were enrolled in the study and received at least 1 dose of study drug.|||log10 copies/mL||Standard Deviation|Mean
2644139|NCT01721109|Secondary|Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Weeks 24 and 48 as Defined by the FDA Snapshot Analysis||Weeks 24 and 48|Full Analysis Set: all participants who were enrolled in the study and received at least 1 dose of study drug.|||percentage of participants|||Number
2644140|NCT01721109|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48 as Defined by the FDA Snapshot Analysis||Weeks 24 and 48|Full Analysis Set: all participants who were enrolled in the study and received at least 1 dose of study drug.|||percentage of participants|||Number
2644141|NCT01721109|Secondary|For Part A, PK Parameter: AUCtau of FTC, TFV, and COBI|AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).|Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10|PK Substudy Analysis Set: all enrolled and treated participants from Part A who had evaluable steady-state pharmacokinetic profiles of the respective analyte of interest at the Day 10 intensive PK visit.|||ng•h/mL||Standard Deviation|Mean
2644142|NCT01721109|Secondary|For Part A, PK Parameter: Cmax of EVG, FTC, TFV, and COBI|Cmax is defined as the maximum concentration of drug.|Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10|PK Substudy Analysis Set: all enrolled and treated participants from Part A who had evaluable steady-state pharmacokinetic profiles of the respective analyte of interest at the Day 10 intensive PK visit.|||ng/mL||Standard Deviation|Mean
2644143|NCT01721109|Secondary|For Part A, PK Parameter: Ctau of EVG, FTC, Tenofovir (TFV), and COBI|Ctau is defined as the observed drug concentration at the end of the dosing interval.|Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10|PK Substudy Analysis Set: all enrolled and treated participants from Part A who had evaluable steady-state pharmacokinetic profiles of the respective analyte of interest at the Day 10 intensive PK visit.|||ng/mL||Standard Deviation|Mean
2644144|NCT01721109|Primary|Incidence of Treatment-Emergent Serious Adverse Events (SAEs) and All Treatment-Emergent Adverse Events (AEs)||Up to Week 48 plus 30 days|Safety Analysis Set: all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2644145|NCT01721109|Primary|For Part A, Pharmacokinetic (PK) Parameter: AUCtau of EVG|AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).|Predose, 2, 4, 4.5, 5, 8, and 12 hours postdose on Day 10|PK Substudy Analysis Set: all enrolled and treated participants from Part A who had evaluable steady-state pharmacokinetic profiles of the respective analyte of interest at the Day 10 intensive PK visit.|||ng•h/mL||Standard Deviation|Mean
2644146|NCT01721096|Secondary|Late Loss(LL): In-stent, In-segment, Proximal, and Distal|Late loss is calculated as MLD post procedure - MLD at follow-up.|8 months post index procedure||||mm|Lesions|Standard Deviation|Mean
2644147|NCT01721096|Secondary|Net Gain: In-stent, In-segment|Late procedural outcome is influenced by both the acute gain provided by the intervention (pre to post) and the subsequent late loss that occurs after the intervention (post to follow-up).The net gain is thus the sum of the offsetting effects of acute gain and late loss (net gain = acute gain - late loss).|8 months post index procedure||||mm|Lesions|Standard Deviation|Mean
2644148|NCT01721096|Secondary|Acute Gain: In-stent, In-segment|The difference between post- and pre-procedural MLD.|8 months post index procedure||||mm|Lesions|Standard Deviation|Mean
2644149|NCT01721096|Secondary|Percent Diameter Stenosis (%DS)|The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|8 months post index procedure|The number of participants analyzed includes subjects who had available follow up data at that time frame|||percentage of DS|Number of lesion analyzed|Standard Deviation|Mean
2644150|NCT01721096|Secondary|Percent Diameter Stenosis (%DS)|The value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.|Post procedure||||percentage of DS|Number of lesion analyzed|Standard Deviation|Mean
2644151|NCT01721096|Secondary|Percent Diameter Stenosis (%DS)|The value calculated as 100 * (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).|Baseline||||percentage of DS|Number of lesion analyzed|Standard Deviation|Mean
2644169|NCT01721096|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)|2 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2660065|NCT01584388|Secondary|Retreatment With Rituximab for Disease Relapse|Number of subjects that relapsed during the course of the trial|12 months||||Participants|||Count of Participants
2644152|NCT01721096|Secondary|Number of Participants Experienced Bleeding|"Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.~Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding"|4 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644153|NCT01721096|Secondary|Number of Participants Experienced Bleeding|"Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.~Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding"|3 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up|||Participants|||Count of Participants
2644154|NCT01721096|Secondary|Number of Participants Experienced Bleeding|"Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.~Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding"|2 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644155|NCT01721096|Secondary|Number of Participants Experienced Bleeding|"Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.~Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding"|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644156|NCT01721096|Secondary|Number of Participants Experienced Bleeding|"Bleeding complications will be defined according to the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) classification of severe, moderate, and mild bleeding events.~Severe or life-threatening: Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate: Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild: Bleeding that does not meet criteria for either moderate or severe bleeding"|8 months post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644157|NCT01721096|Secondary|Number of Participants With All Revascularization|All revascularization includes ischemia driven and non-ischemia driven revascularization.|4 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644158|NCT01721096|Secondary|Number of Participants With All Revascularization|All revascularization includes ischemia driven and non-ischemia driven revascularization.|3 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644159|NCT01721096|Secondary|Number of Participants With All Revascularization|All revascularization includes ischemia driven and non-ischemia driven revascularization.|2 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644160|NCT01721096|Secondary|Number of Participants With All Revascularization|All revascularization includes ischemia driven and non-ischemia driven revascularization.|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644161|NCT01721096|Secondary|Number of Participants With All Revascularization|All revascularization includes ischemia driven and non-ischemia driven revascularization.|8 months post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644162|NCT01721096|Secondary|Number of Participants With Non-Target Vessel Revascularization (Non-TVR)|Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.|4 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644163|NCT01721096|Secondary|Number of Participants With Non-Target Vessel Revascularization (Non-TVR)|Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.|3 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644164|NCT01721096|Secondary|Number of Participants With Non-Target Vessel Revascularization (Non-TVR)|Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.|2 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644165|NCT01721096|Secondary|Number of Participants With Non-Target Vessel Revascularization (Non-TVR)|Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644166|NCT01721096|Secondary|Number of Participants With Non-Target Vessel Revascularization (Non-TVR)|Any revascularization in a vessel other than the target vessel is considered as non-target vessel revascularization.|8 months post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644167|NCT01721096|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)|4 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644170|NCT01721096|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR ( Non-TLR))|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644171|NCT01721096|Secondary|Number of Participants With Target Vessel Revascularization (TLR or TVR (Non-TLR))|Target vessel revascularization (TLR or TVR, non-TLR) includes ischemia driven TVR (TLR or TVR non-TLR) or non-ischemia driven TVR (TLR or TVR non-TLR)|8 months post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644172|NCT01721096|Secondary|Number of Participants With Non-Target Lesion Revascularization (Non-TLR)|Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.|4 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644173|NCT01721096|Secondary|Number of Participants With Non-Target Lesion Revascularization (Non-TLR)|Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.|3 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644174|NCT01721096|Secondary|Number of Participants With Non-Target Lesion Revascularization (Non-TLR)|Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.|2 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644175|NCT01721096|Secondary|Number of Participants With Non-Target Lesion Revascularization (Non-TLR)|Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644176|NCT01721096|Secondary|Number of Participants With Non-Target Lesion Revascularization (Non-TLR)|Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.|8 months post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644177|NCT01721096|Secondary|Number of Participants With Target Lesion Revascularization(TLR)|"Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR.~Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion."|4 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644178|NCT01721096|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR.~Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion."|3 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644179|NCT01721096|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR.~Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion."|2 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644180|NCT01721096|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR.~Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion."|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644181|NCT01721096|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Target lesion revascularization (TLR) includes ischemia driven TLR and non-ischemia driven TLR.~Target lesion revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion."|8 months post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644182|NCT01721096|Secondary|Number of Participants With Myocardial Infarction (MI)|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|4 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644183|NCT01721096|Secondary|Number of Participants With Myocardial Infarction (MI)|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|3 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644184|NCT01721096|Secondary|Number of Participants With Myocardial Infarction (MI)|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|2 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644185|NCT01721096|Secondary|Number of Participants With Myocardial Infarction (MI)|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644186|NCT01721096|Secondary|Number of Participants With Myocardial Infarction (MI)|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|8 months post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644187|NCT01721096|Secondary|Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma"|4 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644188|NCT01721096|Secondary|Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma"|3 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644189|NCT01721096|Secondary|Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma"|2 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644190|NCT01721096|Secondary|Number of of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma"|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644191|NCT01721096|Secondary|Number of Participants Experienced Death (Cardiac Death, Vascular Death and Non-cardiovascular Death)|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma"|8 months post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644192|NCT01721096|Secondary|Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction."|4 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644193|NCT01721096|Secondary|Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction."|3 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644194|NCT01721096|Secondary|Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction."|2 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644215|NCT01721096|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644195|NCT01721096|Secondary|Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction."|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644196|NCT01721096|Secondary|Number of Participants With Cardiac Death or Target Vessel MI (TV-MI)|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery).~TV-MI is defined as myocardial infarction attributed to target vessel myocardial infarction."|8 months post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644197|NCT01721096|Secondary|Number of Participants With Cardiac Death or Myocardial Infarction (MI)|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|4 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644198|NCT01721096|Secondary|Number of Participants With Cardiac Death or Myocardial Infarction (MI)|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|3 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644199|NCT01721096|Secondary|Number of Participants With Cardiac Death or Myocardial Infarction (MI)|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|2 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644200|NCT01721096|Secondary|Number of Participants With Cardiac Death or Myocardial Infarction (MI)|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644201|NCT01721096|Secondary|Number of Participants With Cardiac Death or Myocardial Infarction (MI)|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|8 months post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644202|NCT01721096|Secondary|Number of Participants With Death or Myocardial Infarction (MI)|"All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Those MIs which are not Q-wave MI"|4 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2661921|NCT01566461|Secondary|All-cause Death||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
2644203|NCT01721096|Secondary|Number of Participants With Death or Myocardial Infarction (MI)|"All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Those MIs which are not Q-wave MI"|3 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644204|NCT01721096|Secondary|Number of Participants With Death or Myocardial Infarction (MI)|"All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Those MIs which are not Q-wave MI"|2 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644205|NCT01721096|Secondary|Number of Participants With Death or Myocardial Infarction (MI)|"All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Those MIs which are not Q-wave MI"|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644206|NCT01721096|Secondary|Number of Participants With Death or Myocardial Infarction (MI)|"All deaths includes cardiac death, vascular death and non-cardiovascular death. Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Those MIs which are not Q-wave MI"|8 months post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644207|NCT01721096|Secondary|Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|4 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644208|NCT01721096|Secondary|Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|3 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644209|NCT01721096|Secondary|Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|2 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644210|NCT01721096|Secondary|Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644211|NCT01721096|Secondary|Number of Participants With Cardiac Death/All MI/CI-TLR (MACE)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|8 months post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644212|NCT01721096|Secondary|Number of Participants With Target Vessel Failure(TVF)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|4 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644213|NCT01721096|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).|3 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644214|NCT01721096|Secondary|Number of Participants With Target Vessel Failure (TVF)|Target vessel failure includes cardiac death, MI and ischemia driven TLR; ischemia driven TVR, non TLR; ischemia driven TVR (TLR or TVR, non-TLR).|2 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2662627|NCT01560871|Secondary|Mean Daily Step Counts From Week 1 to Week 6|Each subject was given a pedometer to record his/her step counts every day.|Baseline and 6 weeks||||steps/day||Full Range|Mean
2644220|NCT01721096|Secondary|Number of Participants With All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644221|NCT01721096|Secondary|Number of Participants With All Death/All MI/All Revascularization (DMR)|DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization|8 months post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644222|NCT01721096|Secondary|Number of Participants With Target Lesion Failure (TLF)|Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR|4 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644223|NCT01721096|Secondary|Number of Participants With Target Lesion Failure (TLF)|Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR|3 years post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644224|NCT01721096|Secondary|Number of Participants With Target Lesion Failure (TLF)|Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR|2 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644225|NCT01721096|Secondary|Number of Participants With Target Lesion Failure (TLF)|Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644226|NCT01721096|Secondary|Number of Participants With Target Lesion Failure (TLF)|Target lesion failure includes cardiac death, Target vessel MI and ischemia driven TLR|8 months post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644227|NCT01721096|Secondary|Success Rate: Percentage of Participants With Clinical Success by Patient (Per Patient Base)||Participants will be followed for the duration of hospital stay, an average of 5 days|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||percentage of participants||95% Confidence Interval|Number
2644228|NCT01721096|Secondary|Success Rate: Percentage of Participants With Procedural Success by Lesion|Achievement of final in-scaffold/stent residual stenosis of less than 50% by QCA with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (less than or equal to 7 days).|Participants will be followed for the duration of hospital stay, an average of 5 days|"The number of participants analyzed excludes subjects who were lost-to-follow-up.~Procedural Success rate is calculated per lesion base."|||Percentage of Lesions|Lesions|95% Confidence Interval|Number
2644229|NCT01721096|Secondary|Success Rate: Percentage of Participants With Implant Success Rate by Device|Successful delivery and deployment of the first study scaffold/stent the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 50% by quantitative coronary angiography (QCA).|Participants will be followed for the duration of hospital stay, an average of 5 days|"The number of participants analyzed excludes subjects who were lost-to-follow-up.~Implant Success rate is calculated per stent base."|||percentage of devices|Device used|95% Confidence Interval|Number
2644230|NCT01721096|Primary|Total Number of Participants With Overall Stent Thrombosis|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|1 year post index procedure|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644231|NCT01721096|Primary|Number of Participants With Late Stent Thrombosis (ST)|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|Late (>30 days to 1 year)|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644248|NCT01721057|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|"ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria:~Physician Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders."|Week 12, Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||percentage of participants|||Number
2644232|NCT01721096|Primary|Number of Participants With Subacute Stent Thrombosis (ST)|Stent thrombosis was defined by ARC criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation), or very late (>1 year post stent implantation).|Subacute (>24 hours to 30 days)|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644233|NCT01721096|Primary|Number of Participants With Acute Stent Thrombosis (ST)|Stent thrombosis was defined by Academic Research Consortium (ARC) criteria as definite (angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy), probable (any unexplained death within the first 30 days or, regardless of the time after the index procedure, any Myocardial infarction (MI) related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause), and possible (any unexplained death from 30 days after intracoronary stenting until end of trial follow-up). Stent thrombosis was categorized as acute (0-24 hours post stent implantation), Subacute (>24 hours to 30 days post stent implantation), late (>30 days to 1 year post stent implantation).|Time Frame: Acute (0-24 hours)|The number of participants analyzed excludes subjects who were lost-to-follow-up.|||Participants|||Count of Participants
2644234|NCT01721070|Primary|Cmax|Maximum plasma concentration; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points.|0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.|2 of the 19 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)|||pg/mL||Standard Deviation|Mean
2644235|NCT01721070|Primary|AUC (0-inf)|Total amount of sufentanil absorbed; After each dosing of Sufentanil NanoTab, serial blood samples will be taken at regular time points.|0 (pre-dose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes, and 24 hours after dosing.24 hours|2 of the 19 subjects had incomplete PK data and were excluded from PK analysis (1 due to early withdrawal and 1 due to AE)|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2644236|NCT01721057|Secondary|Population PK: Maximum Concentration at Steady State of Dosing (AUC,ss) of LY3009104||Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24; predose|All randomized participants who received at least 1 dose of study drug with evaluable PK data.|||nanograms per mL per hour (ng/mL*h)||Geometric Coefficient of Variation|Geometric Mean
2644237|NCT01721057|Secondary|Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104||Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24:predose|All randomized participants who received at least 1 dose of study drug with evaluable PK data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2644238|NCT01721057|Secondary|Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores|The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.|Baseline, Week 12; Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug. Change from baseline includes participants with a baseline value and an observed value at the time point being summarized.|||percentage of impairment||Standard Deviation|Mean
2644239|NCT01721057|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)|A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.|Baseline Week 12; Baseline Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||mm||Standard Deviation|Mean
2644240|NCT01721057|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores|European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.|Baseline Week 12; Baseline Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
2644300|NCT01720524|Secondary|Part B: Visual Status of Participants as Assessed by Eye Examinations of the Anterior and Posterior Segments|The results for this outcome measure shall be reported when all participants have completed or discontinued from the 2-year follow-up visit (at the end of 2020).|Months 12 and 24 after end of study treatment Part A||2020-12-31|12/2020||||
2644241|NCT01721057|Secondary|Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.|Baseline, Week 12; Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
2644242|NCT01721057|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores.|"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue."|Baseline, Week 12; Baseline Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
2644243|NCT01721057|Secondary|Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission|The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||percentage of participants|||Number
2644244|NCT01721057|Secondary|Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (DAS28-ESR)|DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), Erythrocyte Sedimentation Rate (ESR) (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
2644245|NCT01721057|Secondary|Change From Baseline in Measures of Simplified Disease Activity Index (SDAI) Score|The SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). A negative change from baseline indicates an improvement.|Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
2644246|NCT01721057|Secondary|Change From Baseline in Measures of Clinical Disease Activity Index (CDAI) Score|• The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.|Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified last observation carried forward (mLOCF) .|||units on a scale||Standard Deviation|Mean
2644247|NCT01721057|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|"ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. ACR70 Responder is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders."|Week 12, Week 24|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||percentage of participants|||Number
2644257|NCT01721044|Secondary|Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib||Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.|All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.|||nanomoles*hour/Liter (nmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2644249|NCT01721057|Secondary|Mean Worst Joint Pain Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries|"Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents no pain and 10 represents pain as bad as you can imagine. Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in joint pain severity rating indicated an improvement in the participant's condition."|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.|||units on a scale||Standard Deviation|Mean
2644250|NCT01721057|Secondary|Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries|"Participants rated their tiredness by selecting a number from 0 to 10 that best described their level of worst tiredness during the past 24 hours, where 0 represents no tiredness and 10 represents as bad as you can imagine. Participants reported their worst tiredness in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in tiredness severity rating indicated an improvement in the participant's condition."|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.|||units on a scale||Standard Deviation|Mean
2644251|NCT01721057|Secondary|Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries|"Participants rated the severity of their MJS by selecting a number from 0 to 10 that best described their overall level of MJS from the time they woke up, where 0 represents no joint stiffness and 10 represents joint stiffness as bad as you can imagine. Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in severity rating indicated an improvement in the participant's condition."|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.|||units on a scale||Standard Deviation|Mean
2644252|NCT01721057|Secondary|Mean Duration of Morning Joint Stiffness(MJS) in the Prior 7 Days as Collected in Electronic Daily Diaries|Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes into daily electronic diaries. If MJS duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit is calculated. A decrease in duration of MJS indicated an improvement in the participant's condition.|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.|||minutes||95% Confidence Interval|Median
2644253|NCT01721057|Secondary|Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) ≤3.3|SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Participant's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||percentage of participants|||Number
2644254|NCT01721057|Secondary|Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.|||units on a scale||Standard Deviation|Mean
2644255|NCT01721057|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty (0 [without any difficulty], 1 [with some difficulty], 2 [with much difficulty], and 3 [unable to do])when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified baseline observation carried forward (mBOCF).|||units on a scale||Standard Deviation|Mean
2644256|NCT01721057|Primary|Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)|"ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders."|Week 12|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using non-responder imputation (NRI).|||percentage of participants|||Number
2644301|NCT01720524|Secondary|Part B: Developmental Progress of Participants as Assessed by Bayley Scales of Infant Development and Behavior Questionnaire|The results for this outcome measure shall be reported when all participants have completed or discontinued from the 2-year follow-up visit (at the end of 2020).|Months 12 and 24 after end of study treatment Part A||2020-12-31|12/2020||||
2644258|NCT01721044|Secondary|Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib||Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose.|All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data. Participants who initially received 2 mg with renal impairment were randomized to 4mg (N=11). Participants starting on 4mg (N=177) and participants rescued to 4mg (N=33) are included in the PK baricitinib 4 mg arm.|||nanomoles/Liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2644259|NCT01721044|Secondary|Percentage Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores|The WPAI-RA participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. Using 6 questions, it yields four types of scores: absenteeism (work time missed), presenteeism (impairment at work), work productivity loss (overall work impairment), and activity impairment, with outcomes expressed as impairment percentages. Percentage work time missed absenteeism: Q2/(Q2+Q4)*100, Percentage impairment while working presenteeism: Q5/10*100; Percentage overall work impairment work productivity loss: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]*100; Percentage activity impairment activity impairment: Q6/10*100. Higher numbers indicate greater impairment and less productivity, that is, worse outcomes.|Baseline, Week 12, Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized.|||Percentage of Impairment||Standard Deviation|Mean
2644260|NCT01721044|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Level Scores|European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.|Baseline, Week 12, Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||Units on a Scale||Standard Deviation|Mean
2644261|NCT01721044|Secondary|Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status.|Baseline, Week 12, Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Units on a Scale||Standard Deviation|Mean
2644262|NCT01721044|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale Scores|The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.|Baseline, Week 12, Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||Units on a Scale||Standard Deviation|Mean
2644263|NCT01721044|Secondary|Change From Baseline in Worst Joint Pain NRS|Participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no joint pain) and 10 representing (pain as bad as you can imagine). Participants rate their joint pain by selecting the one number that describes their worst level of joint pain during the past 24 hours. Total scores ranged from 0-10.|Baseline, Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||Units on a Scale||Standard Deviation|Mean
2644264|NCT01721044|Secondary|Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)|A participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no tiredness) and 10 representing (as bad as you can imagine). Participants rate their tiredness by selecting the one number that describes their worst level of tiredness during the past 24 hours. Total scores ranged from 0-10.|Baseline, Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||Units on a Scale||Standard Deviation|Mean
2644296|NCT01720602|Primary|Rate of Clinical Benefit of Patients Receiving Vorinostat/AI Combination Therapy According to RECIST|"A 90% score (Wilson) confidence interval will be computed for the rate of clinical benefit.~Clinical benefit according to Recist score is defined as: Stable Disease, Partial Remission or Complete Remission. Lack of clinical benefit is defined as Progressive Disease (increase in target lesion size by 20% or more)."|8 weeks||||percentage of patients||90% Confidence Interval|Number
2644265|NCT01721044|Secondary|Change From Baseline in Duration of Participant Reported Outcome - Morning Joint Stiffness|Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on that day. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.|Baseline, Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||Minutes||95% Confidence Interval|Median
2644266|NCT01721044|Secondary|Percentage of Participants Achieving ACR/EULAR Remission - Boolean Remission|The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.|Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Percentage of Participants|||Number
2644267|NCT01721044|Secondary|Change From Baseline in Measures of SDAI Score|"The SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.~The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). A negative change from baseline indicates an improvement."|Baseline, Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||Units on a Scale||Standard Deviation|Mean
2644268|NCT01721044|Secondary|Change From Baseline in Clinical Disease Activity Index Score|The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.|Baseline, Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||Units on a Scale||Standard Deviation|Mean
2644269|NCT01721044|Secondary|Change From Baseline in DAS28 - Erythrocyte Sedimentation Rate (ESR)|DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified last observation carried forward (mLOCF).|||Units on a Scale||Standard Deviation|Mean
2644270|NCT01721044|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR70 Responder is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.|Week 12 and Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Percentage of Participants|||Number
2644271|NCT01721044|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.|Week 12 and Week 24|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Percentage of Participants|||Number
2644297|NCT01720524|Secondary|Part B: Neurological Progress of Participants as Assessed by the Neurology Optimality Score|The results for this outcome measure shall be reported when all participants have completed or discontinued from the 2-year follow-up visit (at the end of 2020).|Months 12 and 24 after end of study treatment Part A||2020-12-31|12/2020||||
2644298|NCT01720524|Secondary|Part B: Safety Assessed by Adverse Events and Survival|The results for this outcome measure shall be reported when all participants have completed or discontinued from the 2-year follow-up visit (at the end of 2020).|Months 12 and 24 after end of study treatment Part A||2020-12-31|12/2020||||
2644272|NCT01721044|Secondary|Percentage of Participants Achieving ACR20 Response|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.|Week 24|Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug. Participants will be analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Percentage of Participants|||Number
2644273|NCT01721044|Secondary|Percentage of Participants Achieving ACR/EULAR Remission - SDAI ≤3.3 - Placebo Versus Baricitinib 2 mg|The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.|Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized or assigned per protocol. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Percent of Participants|||Number
2644274|NCT01721044|Secondary|Change From Baseline in the DAS28 - hsCRP - Placebo Versus Baricitinib 2 mg|DAS28 consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.|||Units on a Scale||Standard Deviation|Mean
2644275|NCT01721044|Secondary|Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 2 mg|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score. Total scores ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.|||Units on a Scale||Standard Deviation|Mean
2644276|NCT01721044|Secondary|Percentage of Participants Achieving ACR20 Response - Placebo Versus Baricitinib 2 mg|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.|Week 12|Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug. Participants will be analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Percentage of Participants|||Number
2644277|NCT01721044|Secondary|Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission - Simplified Disease Activity Index (SDAI) ≤3.3 - Placebo Versus Baricitinib 4 mg|The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.|Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized or assigned per protocol. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Percent of Participants|||Number
2644278|NCT01721044|Secondary|Change From Baseline in the Disease Activity Score Based on a 28-Joint Count (DAS-28) High Sensitivity C-Reactive Protein (hsCRP) - Placebo Versus Baricitinib 4 mg|DAS-28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), high sensitivity C-reactive protein (hsCRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-hsCRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.|||Units on a Scale||Standard Deviation|Mean
2644299|NCT01720524|Secondary|Part B: Audiological Status of Participants as Assessed by Physiological and Behavioral Tests|The results for this outcome measure shall be reported when all participants have completed or discontinued from the 2-year follow-up visit (at the end of 2020).|Months 12 and 24 after end of study treatment Part A||2020-12-31|12/2020||||
2663473|NCT01552369|Secondary|All-cause Mortality|Survival probability at 1 year|Up to 365 days post-transplant|Intent to treat (ITT) population|||survivor probabillity||95% Confidence Interval|Number
2644279|NCT01721044|Secondary|Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 4 mg|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified baseline observation carried forward (mBOCF).|||Units on a Scale||Standard Deviation|Mean
2644280|NCT01721044|Primary|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response - Placebo Versus Baricitinib 4 mg|ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.|Week 12|Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug. Participants will be analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using non-responder imputation (NRI).|||Percentage of Participants|||Number
2644281|NCT01720797|Primary|Tooth Movement Between the Groups|"Accelerated tooth movement effectiveness as measured by dental impressions. These impressions at the 6 month follow-up will evaluate the rate of tooth movement by measuring casts.~Ortholnsight software was used to measure the millimeters of tooth movement from the dental impressions, and then was converted to a Mean and Standard Deviation measurement."|6 months||||percentage of movement||Standard Deviation|Mean
2644282|NCT01720667|Post-Hoc|Imputation Sensitivity Analysis|Analysis of missing data impact on the outcome measures|48 hours|||||||
2644283|NCT01720667|Other Pre-specified|Gather Safety Information on IV Levetiracetam|"Safety information to be collected includes daily recording of any adverse events during the 5 day treatment protocol.~Complete Blood Count and Comprehensive Chemistry panels after 48 hours of treatment collected."|5 days||2019-09-30|09/2019||||
2644284|NCT01720667|Other Pre-specified|Evaluation of the Accuracy of Neonatal Seizure Detection Algorithm|A novel neonatal seizure detection algorithm will be compared to the gold standard of two encephalographers reading 48 hours of neonatal video EEG in the measurement of seizure burden.|48 Hours|||||||
2644285|NCT01720667|Other Pre-specified|Feasibility of Continuous Internet EEG Monitoring|Feasibility of centralized remote access to continuous video EEG monitoring in the NICU via the internet|Subject study duration|||||||
2644286|NCT01720667|Other Pre-specified|Pharmacokinetic Data|"To obtain additional pharmacokinetic data Area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax) of intravenous levetiracetam to confirm findings from our previous pharmacokinetic study."|48 hours|||||||
2644287|NCT01720667|Secondary|Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital Within the Hypoxic Ischemic Encephalopathy (HIE) Population and Treated With Hypothermia||24 hours|HIE participants with hypothermia treatment|||Participants|||Count of Participants
2644288|NCT01720667|Secondary|LEV Dose Escalation Component|Number of babies with seizure control at levetiracetam (60 mg/Kg load) who had not responded to 40 mg/kg load and number of babies with seizure control at 40 mg/kg who had not responded to 20 mg/kg.|24 hours|Babies who received any treatment of either phenobarbital or levetiracetam within the modified intent to treat|||Participants|||Count of Participants
2644289|NCT01720667|Secondary|Number of Neonates With Seizure Termination at 1 Hour After Treatment|A head to head comparison of the efficacy of intravenous levetiracetam versus phenobarbital in the treatment of EEG proven neonatal seizures.|1 hour|Includes 1 participant in each arm who did not have data available for the primary end point at 24 hours|||Participants|||Count of Participants
2644290|NCT01720667|Secondary|Neonates With Seizure Cessation When Given Levetiracetam as First Line Therapy Compared to Phenobarbital at 48 Hours After Treatment|A head to head comparison of the efficacy of intravenous levetiracetam versus phenobarbital in the treatment of EEG proven neonatal seizures.|48 hours|Participants with evaluable data with 48 hours of seizure monitoring|||Participants|||Count of Participants
2644291|NCT01720667|Primary|Neonates With Seizure Cessation When Given Levetiracetam (40-60 mg/kg) as First Line Therapy Compared to Phenobarbital (20-40mg/kg)|"A head to head comparison of the efficacy of intravenous levetiracetam versus phenobarbital in the treatment of EEG proven neonatal seizures.~Seizure cessation from 15 minutes after completion of infusion for 24 hours as assessed by continuous EEG reviewed by neurophysiologists."|24 hours|Treated participants with available primary outcome measure- EEG to 24 hours confirming seizure cessation.|||Participants|||Count of Participants
2644292|NCT01720602|Secondary|Overall Survival|Overall survival is assessed relative to the start of the study therapy to the date of death, from any cause.|From the time of start of study therapy to date of documented death|OS includes one patient still alive 55 months after starting study therapy|||months||Full Range|Median
2644293|NCT01720602|Secondary|Progression-free Survival (PFS)|Progression-free survival is assessed relative to the start of the study therapy. Progression can be determined by RECIST 1.1, elevated tumor markers, worsening clinical symptoms or new lesions identified by FDG-PET or bone scan.|From the time of start of study therapy to documented progression - up to 5 years||||months||Full Range|Median
2644294|NCT01720602|Secondary|Duration of Response|Duration of response will be summarized for responders.|Up to 5 years||||weeks||Full Range|Median
2644295|NCT01720602|Primary|Response Rate According to RECIST|"A 90% score (Wilson) confidence interval will be computed for the response rate.~Clinical benefit according to Recist score is defined as: Stable Disease, Partial Remission or Complete Remission. Lack of clinical benefit is defined as Progressive Disease (increase in target lesion size by 20% or more)."|8 weeks||||percentage of patients||90% Confidence Interval|Number
2644302|NCT01720524|Secondary|Number of Participants With Laboratory Abnormalities|Criteria for laboratory values: Hematology: hemoglobin, hematocrit, red blood cell count <0.8*lower limit of normal (LLN), platelets<0.5*LLN, >1.75*upper limit of normal (ULN), white blood cells count <0.6*LLN, >1.5*ULN; Liver function: total and direct bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN, total protein <0.8*LLN, >1.2*ULN; Renal function: blood urea nitrogen, creatinine >1.3*ULN; Electrolytes: sodium <0.95*LLN, >1.05*ULN, potassium, chloride, calcium, bicarbonate (venous) <0.9*LLN, >1.1*ULN.|Up to 14 days from initiation of study drug infusion|The safety population included all participants treated with study treatment. Here “Overall number of participants analyzed” signifies participants who were evaluable for this outcome measure.|||Participants|||Count of Participants
2644303|NCT01720524|Secondary|Number of Treatment-Emergent Adverse Events (AEs) According to Severity|AE: untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent are events between first infusion of study drug and up to 31 days after end of study drug infusion (up to 45 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Severity criteria: mild=did not interfere with subject's usual function; moderate=interfered to some extent with participant's usual function and severe=interfered significantly with participant's usual function. Missing baseline severities were imputed as mild.|Baseline up to 31 days after end of study drug infusion (up to 45 days)|The safety population included all participants treated with study treatment.|||events|||Number
2644304|NCT01720524|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent are events between first infusion of study drug and up to 31 days after end of study drug infusion (up to 45 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.|Baseline up to 31 days after end of study drug infusion (up to 45 days)|The safety population included all participants treated with study treatment.|||Participants|||Count of Participants
2644305|NCT01720524|Secondary|Central Volume of Distribution (Vc) of Sildenafil and Its Metabolite|Vc is the hypothetical volume into which a drug or a metabolite initially distributes upon administration. It was determined by using a population-based analysis, non-linear mixed-effects modeling (NONMEM), version 7.4.0. Vc was calculated for Sildenafil and its major metabolite, UK-103,320.|Loading dose: prior to the start of infusion, 5, 30 minutes after end of loading infusion on Day 1; Maintenance dose: between 48 to 72, 96 to 120 hours during infusion and immediately prior to end of infusion on Day 1|PK analysis set included all participants randomized and treated who had at least 1 concentration during whole treatment period.|||Liters||Standard Deviation|Mean
2644306|NCT01720524|Secondary|Total Plasma Clearance (CL) of Sildenafil and Its Metabolite|CL is volume of the body fluid/ plasma from which the drug or the metabolite is completely removed per unit time. CL was obtained for Sildenafil and its major metabolite UK-103,320.|Loading dose: prior to the start of infusion, 5, 30 minutes after end of loading infusion on Day 1; Maintenance dose: between 48 to 72, 96 to 120 hours during infusion and immediately prior to end of infusion on Day 1|PK analysis set included all participants randomized and treated who had at least 1 concentration during whole treatment period.|||Liters/hour||Standard Deviation|Mean
2644307|NCT01720524|Secondary|Maximum Plasma Concentration (Cmax) of Sildenafil and Its Metabolite|Cmax was obtained for Sildenafil and its major metabolite UK-103,320.|Loading dose, Day 1: prior to the start of infusion, 5, 30 minutes after end of loading infusion; Maintenance dose: 48 to 72, 96 to 120 hours during infusion and immediately prior to end of maintenance infusion (up to maximum on Day 14)|Pharmacokinetic (PK) analysis set included all participants randomized and treated who had at least 1 concentration during whole treatment period.|||nanogram per milliliter||Standard Deviation|Mean
2644308|NCT01720524|Secondary|Change From Baseline in Ratio of Partial Pressure of Oxygen in Arterial Blood to Fraction of Inspired Oxygen (P/F) at Hours 6, 12 and 24|The ratio of partial pressure of arterial oxygen to fraction of inspired oxygen is a ratio between the oxygen level in the arterial blood and the oxygen concentration that is breathed. It helps to determine the degree of any problems with how the lungs transfer oxygen to the blood.|Baseline, Hours 6, 12 and 24 after start of infusion|The ITT population included all randomized participants treated with study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified rows.|||ratio||95% Confidence Interval|Least Squares Mean
2644309|NCT01720524|Secondary|Change From Baseline in Differential Saturation at Hours 6, 12 and 24 Post-Infusion|Differential oxygenation saturation is a simple way to detect the right-to left shunting at ductus arteriosus using 2 pulse oximeters. It is the difference between pre-ductal and post-ductal sites pulse oxygen saturation (SpO2). Where, pre-duct refers to right upper extremity and post-duct refers to lower limb. Oxygenation saturation is measured as percentage of hemoglobin binding sites occupied by oxygen in the blood.|Baseline, Hours 6, 12 and 24 after start of infusion|The ITT population included all randomized participants treated with study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified rows.|||percentage of hemoglobin||95% Confidence Interval|Least Squares Mean
2644310|NCT01720524|Secondary|Change From Baseline in Oxygenation Index (OI) at Hours 6, 12 and 24 Post-Infusion|Oxygenation index was calculated as the product of fraction of inspired oxygen (FiO2) and mean airway pressure divided by partial pressure of oxygen dissolved in arterial blood (PaO2) [(FiO2*mean airway pressure)/PaO2] measured in centimeter of water per millimeter of mercury (cmH2O/mmHg). FiO2 is the measure of oxygen concentration that is breathed. Mean airway pressure is defined as an average of the airway pressure throughout the respiratory cycle. PaO2 is the measure of oxygen level dissolved in the arterial blood.|Baseline, Hours 6, 12 and 24 after start of infusion|The ITT population included all randomized participants treated with study treatment. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified rows.|||cmH2O/mmHg||95% Confidence Interval|Least Squares Mean
2644311|NCT01720524|Secondary|Percentage of Participants With Individual Components of Treatment Failure|Percentage of participants with individual components of treatment failure (need to start additional treatment targeting PPHN, need to start ECMO, or death) were evaluated. Some participants could have had multiple qualifying events for treatment failure.|14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days)|The ITT population included all randomized participants treated with study treatment.|||percentage of participants||95% Confidence Interval|Number
2644312|NCT01720524|Secondary|Time From Initiation of Intravenous (IV) Study Drug to First Treatment Failure|Time in days, from initiation of IV study drug to first treatment failure (defined as need for additional treatment targeting PPHN, need for ECMO, or death) for participants with treatment failure was evaluated. Kaplan-Meier method was used for estimation. For participants without treatment failure by the endpoint assessment date, data was censored at the endpoint assessment date.|14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days)|The ITT population included all randomized participants treated with study treatment.|||days||95% Confidence Interval|Median
2644313|NCT01720524|Secondary|Time From Initiation of Intravenous (IV) Study Drug to Final Weaning of Mechanical Ventilation|Time in days, from initiation of IV study drug to final weaning of mechanical ventilation among participants achieving final weaning of mechanical ventilation for PPHN was evaluated. Kaplan-Meier method was used for estimation. For subjects with mechanical ventilation beyond 336 hours (14 days) from initiation of IV study drug, data was censored at 14 days.|14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days)|The ITT population included all randomized participants treated with study treatment.|||days||95% Confidence Interval|Median
2644314|NCT01720524|Primary|Treatment Failure Rate|Treatment failure rate was defined as percentage of participants who needed additional treatment targeting PPHN, needed ECMO, or died during the study.|14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days)|The ITT population included all randomized participants treated with study treatment.|||percentage of participants||95% Confidence Interval|Number
2644315|NCT01720524|Primary|Time on Inhaled Nitric Oxide (iNO) Treatment After Initiation of Intravenous (IV) Study Drug For Participants Without Treatment Failure|Time in days, on iNO treatment, for participants without iNO treatment failure, was calculated 14 days from the initiation of IV study drug or hospital discharge, whichever occurred first. iNO treatment failure was defined as need for additional treatment targeting PPHN, need for extra corporeal membrane oxygenation (ECMO), or death during the study.|14 days from the initiation of IV study drug or hospital discharge, whichever occurs first (maximum of 14 days)|The intent-to-treat population (ITT) included all randomized participants treated with study treatment. Here “Overall number of participants analyzed” signifies number of participants without iNO treatment failure.|||days||95% Confidence Interval|Least Squares Mean
2644316|NCT01720446|Secondary|Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate)|Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (pulse rate).|Week 0, up to week 104|Full analysis set included all the randomised subjects.|||beats/min||Standard Error|Least Squares Mean
2644317|NCT01720446|Secondary|Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids)|Estimated ratio to baseline at week 104 during the treatment period in lipid profile (free fatty acids).|Week 0, up to week 104|Full analysis set included all randomised subjects.|||mmol/L||Standard Error|Least Squares Mean
2644318|NCT01720446|Secondary|Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)|Estimated mean change from baseline to last assessment in the trial in patient reported outcomes (PRO). PRO questionnaire (SF-36v2TM) measured the individual overall health related quality of life namely bodily pain, general health, mental component summary, mental health, physical component summary, physical functioning, role-emotional, role-physical, social functioning and vitality. The PRO scores were transformed to a 0−100 scale with higher scores indicating greater health related quality of life.|Week 0, up to week 104|Full analysis set included all randomised subjects.|||Scores on a scale||Standard Error|Least Squares Mean
2644319|NCT01720446|Secondary|Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies|The percentage of subjects that tested positive for anti-semaglutide antibodies at any time point post-baseline during the trial, from week 0 to week 109.|Weeks 0-109|Full analysis set included all randomised subjects|||Percentage of subjects|||Number
2644320|NCT01720446|Secondary|Incidence During the Trial in Other Treatment Outcomes: Adverse Events|Rates (event rate per 100 years of exposure) of treatment emergent adverse events.|Weeks 0-109|Full analysis set included all randomised subjects.|||Event rate per 100 years of exposure|||Number
2644321|NCT01720446|Secondary|Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events|Rates (event rate per 100 exposure years) of severe or blood glucose confirmed symptomatic hypoglycaemia defned as an episode that was severe according to the American diabetic association (ADA) classification or blood glucose (BG) confirmed by a PG value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.|Week 0 - 109|Full analysis set included all randomised subjects.|||Event rate per 100 exposure years|||Number
2644322|NCT01720446|Secondary|Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs|Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (diastolic blood pressure and systolic blood pressure).|Week 0, up to week 104|Full analysis set included all the randomised subjects.|||mmHg||Standard Error|Least Squares Mean
2644323|NCT01720446|Secondary|Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio|Estimated ratio to baseline in urinary albumin to creatinine ratio at week 104 during the treatment period.|Week 0, up to week 104|Full analysis set included all the randomised subjects|||mg/g||Standard Error|Least Squares Mean
2644324|NCT01720446|Secondary|Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile|Estimated ratio to baseline at week 104 during the treatment period in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides).|Week 0, up to week 104|Full analysis set included all randomised subjects.|||mg/dL||Standard Error|Least Squares Mean
2663474|NCT01552369|Primary|Incidence of Cytomegalovirus (CMV) Disease.|CMV disease as verified by an independent end point committee|365 days post-transplant|All randomized subjects|||participants|||Number
2644325|NCT01720446|Secondary|Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight|Estimated mean change from baseline to last assessment in body weight in the trial during the treatment period.|Week 0, up to week 104|Full analysis set included all the randomised subjects. As specified in the protocol, the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.|||kg||Standard Error|Least Squares Mean
2644326|NCT01720446|Secondary|Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose|Estimated mean change from baseline to last assessment in fasting plasma glucose in the trial during the treatment period.|Week 0, up to week 104|Full analysis set included all the randomised subjects.|||mmol/L||Standard Error|Least Squares Mean
2644327|NCT01720446|Secondary|Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c)|Estimated mean change from baseline in glycosylated haemoglobin (HbA1c) to last assessment in the trial during the treatment period.|Week 0, up to week 104|Full analysis set included all the randomised subjects|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
2644328|NCT01720446|Secondary|Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke|Percentage of subjects experiencing a first occurrence of all-cause death, non-fatal MI, or non-fatal stroke.|Time from randomisation up to end of follow-up (scheduled at week 109)|Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.|||percentage of subjects|||Number
2644329|NCT01720446|Secondary|Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome|Percentage of subjects experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as either MACE, revascularisation [coronary and peripheral], unstable angina requiring hospitalisation or hospitalisation for heart failure).|Time from randomisation up to end of follow-up (scheduled at week 109)|Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.|||percentage of subjects|||Number
2644330|NCT01720446|Secondary|Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome|Percentage of subjects experiencing first occurrence of an expanded composite CV outcome (defined as either MACE, revascularisation [coronary and peripheral], unstable angina requiring hospitalisation or hospitalisation for heart failure)|Time from randomisation up to end of follow-up (scheduled at week 109)|Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.|||percentage of subjects|||Number
2644331|NCT01720446|Primary|Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke|Percentage of subjects experiencing a first event of a major adverse cardiovascular event (MACE), defined as cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.|Time from randomisation up to end of follow-up (scheduled at week 109)|Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.|||percentage of subjects|||Number
2644332|NCT01720316|Secondary|Auditory Evoked Potentials - P50 Ratio (P50 S2/P50 S1 Amplitude) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT|Auditory evoked potentials amplitude: P50 ratio (S2/S1). Participants were assessed at baseline and in week 6 of open-label glycine treatment.|Recordings at baseline and week 6 of glycine|Only one subject received these procedures because normal hearing is required.|||ratio|||Number
2644333|NCT01720316|Secondary|Auditory Evoked Potentials in Gammas Oscillations (the Power Spectrum is Measured in Microvolts Squared) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT|Auditory evoked potentials gamma: G40 hz phase locking at fz and cz; G20 hz phase locking response at fz and cz G30 hz phase locking response at fz and cz. Participants were assessed at baseline and in week 6 of open-label glycine treatment.|Recordings at baseline and week 6 of glycine|Only one subject received these procedures because normal hearing is required.|||microvolts squared|||Number
2644334|NCT01720316|Secondary|Auditory Evoked Potentials in Amplitude (Degrees Measured in Microvolts) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT|Auditory evoked potentials amplitude: P300 at fz, cz, and pz; N100 at fz and cz; P200 at fz and cz; P50 S1 and S2 amplitude; mismatch negativity (MMN) at fz and cz. Participants were assessed at baseline and in week 6 of open-label glycine treatment.|Recordings at baseline and week 6 of glycine|Only one subject received these procedures because normal hearing is required.|||microvolts|||Number
2644335|NCT01720316|Secondary|Change in Magnocellular Pathway Function on Glycine Compared With Baseline. No Data Were Collected.|functional magnetic resonance imaging|6 weeks per treatment arm|Data not collected.||||||
2644336|NCT01720316|Secondary|Auditory Evoked Potentials in Latency (Msec) at BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF TREATMENT WITH GLYCINE|Auditory evoked potentials latency: P300 at fz, cz, and pz); N100 at fz and cz); P200 at fz and cz. Participants were assessed at baseline and in week of open-label glycine treatment.|Recordings at baseline and week 6 of glycine|Only one subject received these procedures because normal hearing is required.|||msec|||Number
2644337|NCT01720316|Secondary|Brain GABA Metabolite Levels (GABA/Creatine Ratio: GABA/Cr) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT|Magnetic resonance spectroscopy GABA/Cr. Participants were assessed 1) pre-glycine treatment (baseline) and 2) in week 6 of open-label glycine treatment measured in posterior occipital cortex.|Baseline and week 6 of glycine||||ratio|||Number
2644338|NCT01720316|Secondary|Brain Glutamate Metabolite Levels (Glutamate/Creatine Ratio: Glu/Cr) at 1) BASELINE - Pre-glycine Treatment and 2) IN WEEK 6 OF GLYCINE TREATMENT|magnetic resonance spectroscopy - glutamate metabolite level. Participants were assessed 1) pre-glycine treatment and in week 6 of open-label glycine treatment. Measured in posterior occipital cortex.|baseline and week 6 of glycine||||ratio|||Number
2663483|NCT01552213|Secondary|Number of Participants With Intrauterine Fetal Demise||Duration of pregnancy and up to 28 days after delivery||||Participants|||Count of Participants
2644339|NCT01720316|Secondary|Brain Glycine/CR Ratio|magnetic resonance spectroscopy: glycine/creatine ratio. Participants were assessed at 1) BASELINE PRE-GLYCINE TREATMENT: pre-glycine challenge drink, 60 minutes post challenge drink, 80 minutes post challenge drink, 100 minutes post challenge drink, and 120 minutes post challenge drink (0.4 g/kg up to max of 30 g); and 2) IN WEEK 6 OF OPEN-LABEL GLYCINE TREATMENT: pre-glycine dose, and 60 minutes, 80 minutes, 100 minutes and 120 minutes post daily dose of glycine. Measured in posterior occipital cortex|baseline (pre-challenge, 60, 80, 100, 120 minutes post-challenge), and week 6 of glycine (pre-dose and 60, 80, 100, 120 minutes post-dose||||ratio|||Number
2644340|NCT01720316|Primary|Depression Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period|Hamilton Depression Scale measures severity of depression symptoms. The sum of ratings for 9 depression symptoms are measured on a scale from 0-2 with 0 meaning no symptoms and 2 meaning some level of severity of that specific symptom. The rating for 1 depression symptom is measured on a scale from 0-3 with 0 meaning no symptoms and 3 meaning a severe level of that specific symptom. The sum of ratings for 11 depression symptoms are measured on a scale from 0-4 with 0 meaning no symptoms and 4 meaning a severe level of that specific symptom. The three sums are added to produce an overall depression rating scale score ranging from 0-65.|baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period||||units on a scale|||Number
2644341|NCT01720316|Primary|Mania Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period|Young Mania Rating Scale (YMRS) measures severity of manic symptoms. The sum of ratings for 7 symptoms of mania is measured on a scale from 0-4 and the sum of 4 symptoms of mania is measured on a scale from 0-8 to yield a total score ranging from 0-60, with 0 meaning no manic symptoms and 60 meaning severe manic symptoms.|baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period||||units on a scale|||Number
2644342|NCT01720316|Primary|Clinical Global Impression (CGI) Therapeutic Effect Scores at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period|Clinical Global Impression (CGI) therapeutic effect scores measure degree of improvement as marked (1), moderate (5), minimal (9) or unchanged/worse (13).|at 2 weeks, 4 weeks, and 6 weeks within each treatment period||||score|||Number
2644343|NCT01720316|Primary|Clinical Global Impression (CGI) Severity Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Within Each Treatment Period|Clinical Global Impression (CGI) severity scores measure severity of mental illness on a scale of 1-7 where 1 means normal, not at all ill, 2 means borderline mentally ill, 3 means mildly ill, 4 means moderately ill, 5 means markedly ill, 6 means severely ill and 7 means among the most extremely ill patients.|CGI at baseline and at 2 weeks, 4 weeks, and 6 weeks per treatment period||||units on a scale|||Number
2644344|NCT01720316|Primary|Brief Psychiatric Rating Scale (BPRS) Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks Positive and Negative Symptom Scores at Baseline and at 2, 4, and 6 Weeks During Intervention 1, Intervention 2, and During Open-label Glycine|Total BPRS score measures severity of 18 psychiatric symptoms. Each symptom is scored 1-7 with the total score ranging from 18-126. 18 means no symptoms and 126 means very severe symptoms.|baseline and at 2 weeks, 4 weeks, and 6 weeks within and after each treatment period||||units on a scale|||Number
2644345|NCT01720316|Primary|Glycine Plasma Amino Acid Levels at Baseline, During Glycine Treatment, During Placebo Treatment and During Open-label Glycine|Plasma glycine levels; normal range is 122-467 nM/mL|At baseline, during glycine treatment, during placebo treatment and during open-label glycine||||nM/mL|||Number
2644346|NCT01720316|Primary|Neurocognitive Function at Baseline, During Glycine Treatment, During Placebo Treatment and During Open-label Glycine|Scores on each of 8 domains of cognitive function (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning/problem solving, social cognition, overall composite). Scores are T scores ranging from 0-100, with 50 representing the mean for a population based on a normal distribution; standard deviation of 10. Only overall composite score is entered.|At baseline, during glycine treatment, during placebo treatment and during open-label glycine|Data provided for each participant separately.|||units on a scale|||Number
2644347|NCT01720316|Primary|Positive and Negative Symptom Scores at Baseline and at 2 Weeks, 4 Weeks, and 6 Weeks During Intervention 1 (Glycine or Placebo), Intervention 2 (Glycine or Placebo), and During Open-label Glycine|Positive and Negative Symptom Scale (PANSS) measures positive and negative symptoms of schizophrenia. The sum of ratings for seven positive symptoms are measured on a scale from 7-49 with 7 meaning no symptoms and 49 meaning severe symptoms.|baseline and at 2 weeks, 4 weeks, and 6 weeks within each treatment period and after each treatment period||||units on a scale|||Number
2644348|NCT01720277|Other Pre-specified|Recruit, Enroll, and Randomize Nursing Homes Per Calculated Sample Size|This outcome evaluates our ability to recruit and enroll nursing facilities that meet our inclusion and exclusion criteria, and ensure nursing home residents receive either high-dose or standard-dose influenza vaccine|1 year|Nursing home facilities randomized to receive high dose or standard dose vaccine.|||Nursing Homes|Nursing Homes||Number
2644349|NCT01720277|Secondary|Change in Residents' Functional Status|The secondary outcome will establish our methodology for measuring change in functional status of nursing home residents using Activities of Daily Living (ADL) data in the Minimum Data Set (MDS). A change in functional status is defined as a decline in physical functioning by at least 4 points on the 28-point ADL scale.|1 year||||Participants|||Count of Participants
2644350|NCT01720277|Primary|Total All-cause Hospitalizations|The primary outcome will establish our methodology for measuring all-cause hospitalizations using the Minimum Data Set (MDS).|1 year|We identified long-stay nursing home residents and evaluated outcomes (e.g. hospitalizations, functional status).|||events|||Number
2644351|NCT01720264|Secondary|Number of Subjects With Treatment Related Adverse Events Grade 3 and 4 Non-hematological Toxicities|Number of unique patients who had a treatment related (possible, probable or definite) non-hematological adverse event that was graded 3 or greater.|Day 0 up to 3 years|All patients enrolled and received treatment.|||Participants|||Count of Participants
2644387|NCT01719861|Secondary|Desipramine Maximum Dose|Assessed as the median per patient maximum dose (MD) using intra-patient dose escalation, and reported as the highest dose of desipramine administered continuously for 1 week or greater.|Up to 6 weeks|All patients who were enrolled and started therapy.|||mg daily||Full Range|Median
2646319|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 29 to Day 56) for Astma Symptom Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)|Full Analysis set|||symptom free days||90% Confidence Interval|Least Squares Mean
2644352|NCT01720264|Secondary|Time to Platelet Engraftment|Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of three consecutive Complete Blood Counts (CBCs) obtained on different days after transplantation during which the platelet count is at least 20 x109/l. The CBCs obtained should be at least seven days after the most recent platelet transfusion. Only patients who achieved engraftment of platelets will be included in the analysis. The median and 95% confidence intervals will be provided.|Transplant (Day 0) up to 1 year|All patients who received treatment and who achieved platelet recovery/engraftment of platelets.|||days||95% Confidence Interval|Median
2644353|NCT01720264|Secondary|Time to Neutrophil Engraftment|Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients surviving at least 14 days after transplant will be evaluable for this endpoint. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals will be provided.|Transplant (Day 0) up to 1 year|All patients who received treatment and survived at least 14 days after transplant.|||days||95% Confidence Interval|Median
2644354|NCT01720264|Primary|The Percent of Subjects Engrafting by Day +30 After Transplantation|Percent of patients and the 95% Binomial Confidence interval who were able to achieve neutrophils engraftment (defined as the date of the first of three consecutive ANC values obtained on different days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l) by 30 days following transplant.|Day 0 to Day +30 post transplant|All patients who received treatment and were followed after transplant.|||percentage of participants||95% Confidence Interval|Number
2644355|NCT01720251|Other Pre-specified|Immunological Markers: Specific IgE and IgG4|blood samples will be drawn at the above time points to measure immunological markers: specific IgE and IgG4|before treatment, 4 weeks after the last injection and 2 weeks before, at the peak time and within 2 weeks after the end of the expected birch pollen season 2013|||||||
2644356|NCT01720251|Secondary|Safety and Tolerability|Adverse events will be collected throughout the trial period and will be reported as Treatment emergent adverse events occurring between start of treatment and 28 days after completion of treatment for each subject|from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks|||||||
2644357|NCT01720251|Secondary|Quality of Life|mini-RQLQ questionnaires|up to 6 weeks during the birch pollen season 2013|||||||
2644358|NCT01720251|Primary|Combined Rhinoconjunctivitis Symptom and Medication Score|"The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first.~The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2"|up to 6 weeks during the birch pollen season 2013||||score (maximum=3)||Standard Deviation|Mean
2644359|NCT01720173|Other Pre-specified|Pre-treatment Plasma Concentration Levels of VEGF, BMP9, BMP10, and ALK1|Associated with measures of clinical response to treatment, including PFS and OS.|Baseline|||||||
2644360|NCT01720173|Other Pre-specified|IHC Expression Levels of VEGF, FGF, TGFB, ALK1, CD105 and Other Markers|Associated with measures of clinical response to treatment, including PFS and OS.|Baseline|||||||
2644361|NCT01720173|Other Pre-specified|Gene Expression Levels of ALK1 and Other Markers|Associated with measures of clinical response to treatment, including PFS and OS.|Baseline|||||||
2644362|NCT01720173|Secondary|Progression-free Survival|Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.|Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease, up to 5 years.|Eligible and treated participants|||months||95% Confidence Interval|Median
2644363|NCT01720173|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.|Eligible and treated participants.|||months||95% Confidence Interval|Median
2644364|NCT01720173|Primary|Objective Tumor Response|Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.|Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease, up to 5 years.|Eligible and treated participants|||percentage of participants||90% Confidence Interval|Number
2644365|NCT01720173|Primary|Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0|Number of participants with a maximum grade of 3 or higher during the treatment period.|Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up|Eligible and treated patients|||Participants|||Count of Participants
2644366|NCT01720173|Primary|Progression-free for at Least 6 Months Without Non-protocol Therapy From Study Entry|Percentage of participants who survive progression-free for at least 6 months without non-protocol therapy after study entry. Progression is assessed by RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.|Every other cycle for first 6 months|Eligible and treated participants|||percentage of participants||90% Confidence Interval|Number
2644367|NCT01720069|Secondary|Assessment of Acceptability of the Device|Percentage of subjects that overall found it very easy or fairly easy to use the inhaler, based on inhaler acceptability questionnaire|16 weeks||||Participants|||Count of Participants
2644368|NCT01720069|Secondary|Number of Participants With Withdrawals Due to Worsening of Asthma||16 weeks||||Participants|||Count of Participants
2644369|NCT01720069|Secondary|Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Weekly Average Asthma Night-time Symptom Score|To measure the change from baseline to end of study for the weekly mean asthma night time symptom score, scored from 0 (not at all bothered) to 6 (severely bothered).|Baseline and 16 weeks||||score on a scale||Standard Deviation|Mean
2644370|NCT01720069|Secondary|Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Weekly Morning Pre-dose Peak Expiratory Flow (PEF)||Baseline and 16 weeks||||L/min||Standard Deviation|Mean
2644371|NCT01720069|Secondary|Mean Change From Start of Treatment Baseline to End of Study (Week 16) for Asthma Control Questionnaire (ACQ-5) Mean Total Score|Change from baseline to end of study (week 16) in 5 item asthma control questionnaire (ACQ-5) mean total score (range 0 (better) to 6 (worse)). The mean total score is calculated as the mean for each subject at each visit of 5 questions, each scored from 0 (better) to 6 (worse).|Baseline and 16 weeks|Full Analysis Set was analyzed, but number of patients represents subjects with both start of treatment baseline value and end of treatment value where a Last Observation Carried Forward (LOCF) approach was used to impute values of missing post-baseline visits; 1 subject had no post-dose ACQ-5 assessment, baseline value was not carried forward.|||score on a scale||Standard Deviation|Mean
2644372|NCT01720069|Secondary|Mean Change From Start of Treatment Baseline to End of Study (Week 16) for In-clinic Morning Pre-Dose Forced Expiratory Volume In 1 Second (FEV1)||Baseline and 16 weeks||||Liters||Standard Deviation|Mean
2644373|NCT01720069|Primary|Mean Prednisone/Prednisolone Dose for Analysis (PDA) at End of Study (Week 16)|The mean asthma control prednisone/prednisolone dose at end of study (week 16)|16 weeks|The Full Analysis Set (FAS) was analyzed, however 7 subjects are not included because they had no OCS dose adjustment assessment post-randomisation, and baseline values were not carried forward.|||mg||Standard Deviation|Mean
2644374|NCT01720043|Primary|Efficacy of Velcade|Effect of VELCADE at 1.0-1.3 mg/m2 dose on platelet aggregation at 24 and 48 hour post-infusion in patients with multiple myeloma. The following components of platelet aggregation were evaluated at varying levels: Collagen, Adenine di-Phosphate (ADP), Arachidonic acid, and Ristocetin.|48 hours|One patient withdrew before receiving the 24 hour dose, leaving 7 patients evaluable for response.|||percentage||Standard Deviation|Mean
2644375|NCT01719900|Other Pre-specified|Fecal Bile Acid Concentration|Fecal cholic acid concentration measured at 12 weeks|12 weeks||||µmol/g dry weight||Standard Error|Mean
2644376|NCT01719900|Other Pre-specified|Fecal Short-chain Fatty Acid Concentrations|Fecal acetate concentration measured at 12 weeks|12 weeks||||µmol/g dry weight||Standard Error|Mean
2644377|NCT01719900|Other Pre-specified|Serum Metabolomics at 12 Weeks|Serum metabolomics measured at 12 weeks using 1H-NMR analysis. Principal component analysis is used to see if two or more groups of samples separate into distinct clusters. The principal components generated in this analysis range from 0-100%. A higher value means that more variability among the samples is explained by this principal component.|12 weeks||||score on a scale of 1-100%|||Number
2644378|NCT01719900|Other Pre-specified|Alpha Diversity of Gut Microbiota at 12 Weeks|Gut microbiota alpha diversity measured at 12 weeks as Chao index. Chao index is an abundance-based estimator of species richness within a sample. There are no preset minimum and maximum values but scores typically range from 0 to 4000. A higher score is generally regarded as better.|12 weeks||||Score on a scale of 1-4000||Standard Error|Mean
2644379|NCT01719900|Other Pre-specified|Serum Cytokine at 12 Weeks|Serum cytokine IL-6 measured at 12 weeks|12 weeks||||pg/ml||Standard Error|Mean
2644380|NCT01719900|Other Pre-specified|Cholesterol Profile at 12 Weeks|Serum LDL (low density lipoprotein) cholesterol|12 weeks||||mmol/l||Standard Error|Mean
2644381|NCT01719900|Secondary|Change in Objective Appetite at 12 Weeks|Value at 12 weeks minus baseline energy intake during weighed lunch buffet.|12 weeks minus baseline||||% of baseline food intake||Standard Error|Mean
2644382|NCT01719900|Secondary|HbA1c at 12 Weeks|Assessed via HbA1c|12 weeks||||% in blood||Standard Error|Mean
2644383|NCT01719900|Primary|Change in Fat Mass at 12 Weeks|Value at 12 weeks minus value at baseline assessed with dual energy x-ray absorptiometry.|Value at 12 weeks minus value at baseline||||kg||Standard Error|Mean
2644384|NCT01719861|Secondary|Median Overall Survival (OS)|Median overall survival was defined as time from enrollment to death from any cause calculated using the Kaplan-Meier method.|From start of enrollment until death, no limit|All patients who were enrolled and started therapy.|||Months||Full Range|Median
2644385|NCT01719861|Secondary|Progression-free Survival (PFS), Median|Median PFS was defined as the time from randomization to disease progression (or death if the patient died before progression) calculated using the Kaplan-Meier method.|Up to 5 years from enrollment to radiographic progression or drug discontinuation|All patients who were enrolled and started therapy.|||Months||Full Range|Median
2644386|NCT01719861|Secondary|Median Serum Desipramine Levels During Treatment|"Median serum desipramine levels during treatment is reported as the median of the maximum steady state serum concentration observed in all patients.~Therapeutic concentration of desipramine is 100 to 300 ng/mL, and toxic concentration is > 300 ng/mL."|Up to 6 weeks|All patients who were enrolled and started therapy.|||ng/mL||Full Range|Median
2644448|NCT01718522|Secondary|Hemoglobin A1c (HbA1c) Values (%) at Baseline and 3 Months||Baseline and 3 months||||Percentage||Standard Deviation|Mean
2644388|NCT01719861|Primary|Overall Response Rate (ORR)|Overall response rate (ORR) was assessed as the number of patients who achieve either a partial (PR) or complete response (CR) measured by CT scans and Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria, divided by the total number of patients treated on the study. CR: Disappearance of all target lesions, all non-target lesions, and no new lesion. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesion.|6 weeks|All patients who were enrolled and started therapy.|||percentage of participants|||Number
2644389|NCT01719783|Other Pre-specified|Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Central Memory T Cell Responses|"Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.~An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response."|28 days (Dose 1) and 56 days (Dose 2)|Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured|||Participants|||Count of Participants
2644390|NCT01719783|Other Pre-specified|Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Effector Memory T Cell Responses|"Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.~An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response."|28 days (Dose 1) and 56 days (Dose 2)|Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured|||Participants|||Count of Participants
2644391|NCT01719783|Other Pre-specified|Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Central Memory T Cell Responses|"Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.~An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response."|28 days (Dose 1) and 56 days (Dose 2)|Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured|||Participants|||Count of Participants
2644392|NCT01719783|Other Pre-specified|Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Effector Memory T Cell Responses|"Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.~An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response."|28 days (Dose 1) and 56 days (Dose 2)|Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured|||Participants|||Count of Participants
2644393|NCT01719783|Other Pre-specified|Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Responses|"Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.~An increase in the number of antigenic-specific T cells greater than 3 standard deviations over the mean placebo values was regarded as a positive T cell response."|28 days (Dose 1) and 56 days (Dose 2)|Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured|||Participants|||Count of Participants
2644394|NCT01719783|Other Pre-specified|Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Responses|"Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old embryonated chicken eggs (ECE) followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.~An increase in the number of antigenic-specific T cells greater than 3 standard deviations over the mean placebo values was regarded as a positive T cell response."|28 days (Dose 1) and 56 days (Dose 2)|Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured|||Participants|||Count of Participants
2644395|NCT01719783|Secondary|Geometric Mean Titers (GMT) for Serum Neutralizing Antibodies|Geometric mean titers for serum neutralizing antibodies measured by microneutralization assay|0 days, 28 days (Dose 1) and 56 days (Dose 2)|Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured|||titer||95% Confidence Interval|Geometric Mean
2644396|NCT01719783|Secondary|Geometric Mean Titers for Serum HAI Antibodies|Geometric mean titers for serum hemagglutination inhibition antibodies|0 days, 28 days (Dose 1) and 56 days (Dose 2)|Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured|||titer||95% Confidence Interval|Geometric Mean
2644397|NCT01719783|Secondary|Number/Percentage of Vaccinated Participants Shedding Influenza Virus After Second Dose|Nasal swabs were collected and used for Reverse transcription polymerase chain reaction (rRTPCR) assays to detect shedding of influenza virus for days 29-34 of the study (6 days after the second vaccination).|6 days post-vaccination|Participants receiving second dose of study vaccine and with post-vaccination immunologic parameters measured|||Participants|||Count of Participants
2644398|NCT01719783|Secondary|Number/Percentage of Vaccinated Participants Shedding Influenza Virus After First Dose|Nasal swabs were collected and used for Reverse transcription polymerase chain reaction (rRTPCR) assays to detect shedding of influenza virus for days 1-6 of the study.|6 days post-vaccination|Participants receiving first dose of study vaccine and with post-vaccination immunologic parameters measured|||Participants|||Count of Participants
2644449|NCT01718522|Secondary|Number (n) of Excursions <40 mg/dl Per Sensor Day at Baseline and 3 Months||Baseline and 3 months||||excursions||Standard Deviation|Mean
2644399|NCT01719783|Secondary|Number/Percentage of Subjects With Seroconversion for IgA in Saliva|IgA = Immunoglobulin Class A antibodies. Determined using ELISA using whole purified H5N2.|28 days (Dose 1) and 56 days (Dose 2)|Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured|||Participants|||Count of Participants
2644400|NCT01719783|Secondary|Number/Percentage of Subjects With Seroconversion for Secretory IgA|IgA antibodies from the nasal mucosa detected in nasal wick specimens. Determined using ELISA using whole purified H5N2|28 days (Dose 1) and 56 days (Dose 2)|Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured|||Participants|||Count of Participants
2644401|NCT01719783|Secondary|Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin G (IgG)|Determined using ELISA using whole purified H5N2.|28 days (Dose 1) and 56 days (Dose 2)|Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured|||Participants|||Count of Participants
2644402|NCT01719783|Secondary|Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin A (IgA)|IgA = immunoglobulin class A antibodies Determined using ELISA using whole purified H5N2|28 days (Dose 1) and 56 days (Dose 2)|Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured|||Participants|||Count of Participants
2644403|NCT01719783|Secondary|Number/Percentage of Subjects With Serum Neutralizing Antibodies|"Defined as a four-fold or greater antibody rise in titer from pre-vaccination level.~Measured by microneutralization assay in Madin-Darby canine kidney cells (MDCK)."|28 days (Dose 1) and 56 days (Dose 2)|Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured|||Participants|||Count of Participants
2644404|NCT01719783|Secondary|Number/Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI)|"Defined as a four-fold or greater antibody rise in titer from pre-vaccination level.~HAI = hemagglutination-inhibition, conducted using World Health Organization (WHO)-recommended protocols."|28 days (Dose 1) and 56 days (Dose 2)|Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured|||Participants|||Count of Participants
2644405|NCT01719783|Primary|Adverse Events by Severity|Occurrence of participants with adverse events associated with intranasal administration, by worst grade of severity|6 days|All participants that received either a vaccine or placebo, by dose|||Participants|||Count of Participants
2644406|NCT01719757|Secondary|Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject|The overall satisfactions by investigators & subjects were assessed 5 steps such as Very good, Good, Satisfactory, Bad, Very bad.|4 weeks|Intent to treat analysis set(Last observational carried forward)|||participants|||Number
2644407|NCT01719757|Secondary|Change of Constipation Assessment From Baseline to Visit 2(End Visit)|Constipation assessment(5-point scale; 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe, for the patient's judgment of the intensity of symptoms)|4 weeks|Intent to treat analysis set(Last observational carried forward)|||score||Standard Deviation|Mean
2644408|NCT01719757|Secondary|Change of Eastern Cooperative Oncology Group(ECOG) Performance Status|"If ECOG P.S score is increased from baseline to visit2, the results mean that QOL was worse.~ECOG P.S grade: 0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work,2=Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours,3=Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours,4=Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair,5=Death."|4weeks|Intent to treat analysis set: 304|||Score||Standard Deviation|Mean
2644409|NCT01719757|Primary|Change in Numeric Rating Scales (NRS) Score|Primary objective: Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline (visit 1) to study end (visit 2). NRS score was measured from 0 (No pain) to 10(worst pain imaginable).|4 weeks|Intent to treat analysis set: 304|||units on a scale||Standard Deviation|Mean
2644410|NCT01719744|Secondary|Number of Certain Biomarkers in Participants Compared to Progression Free Survival.||2 years||2020-12-31|12/2020||||
2644411|NCT01719744|Secondary|Objective Response Rate|"Objective Response Rate (ORR) = CR+ PR. ORR is evaluated per RECIST v1.1 criteria.~Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions."|From start of study treatment until disease progression or death, whichever occurs first.||||percentage of participants||95% Confidence Interval|Number
2644412|NCT01719744|Secondary|Number of and Severity of Adverse Events Per Participant|Number of participants who experienced a grade 3 or higher adverse event. Reporting threshold 5%|2 years||||participants|||Number
2644413|NCT01719744|Primary|6-month Progression-free Survival Rate (PFS)|Number of patients with no progression of disease at 6 months|From start of study treatment until disease progression or death, whichever occurs first, up to 6 months.||||participants||95% Confidence Interval|Number
2644414|NCT01719653|Secondary|Adequate/Inadequate Scale|The cleanliness of the colon as rated by the gastroenterologist using an adequate/inadequate scale where an adequate preparation is defined as being able to see at least 95% of the mucosa of the colon after washing and suctioning; otherwise, the preparation is rated as inadequate.|At completion of colonoscopy - day 1||||Participants|||Count of Participants
2644415|NCT01719653|Secondary|Boston Bowel Preparation Scale|The quality of the colon preparation as graded using Boston Bowel Preparation total scores is range from 0 (very poor) to 9 (outstanding).|At completion of colonoscopy - day 1||||units on a scale||Standard Deviation|Mean
2644416|NCT01719653|Primary|Chicago Bowel Preparation Scale|The quality of the colon preparation as graded using our new Chicago Bowel Preparation Scale (BPS) (Adventist Midwest Region Institutional Review Board, AMH 2010-01-80; ClinicalTrials.gov NCT01063049). Chicago BPS total score is ranges from 0 (very poor) to 36 (outstanding). Modified Chicago BPS total score is ranges from 0 (very poor) to 33 (outstanding). Chicago BPS Fluid score is ranges from 0 (dry) to 3 (wet).|At completion of colonoscopy - day 1||||units on a scale||Standard Deviation|Mean
2644450|NCT01718522|Primary|Number (n) of Excursions <70 mg/dl Per Sensor Day at Baseline and 3 Months||baseline and 3 months||||excursions||Standard Deviation|Mean
2644417|NCT01719367|Primary|Change in Pre- and Post-atenolol Ventricular Rate Response After 10 and 15 Minutes of Exercise|After baseline vital signs and ECG are recorded, patients will be asked to perform a baseline standardized (modified Bruce) exercise protocol. Heart rate will be recorded during each stage of the exercise protocol. Patients will be asked to exercise to sub-maximal exertion. After the baseline exercise protocol, patients will be given a single dose of oral atenolol. After a two hour waiting period to allow for peak effect of atenolol, patients will repeat the exercise protocol. The primary study outcome measure will be the difference in pre- and post-atenolol ventricular rate response to exercise. The primary outcome measure will be compared in patients with various polymorphisms in genes that might play a role in the inter-individual response to atenolol.|after 10 amd 15 minutes of exercise||||beats per minute||95% Confidence Interval|Mean
2644418|NCT01719367|Primary|Change in Pre- and Post-atenolol Ventricular Rate Response After 5 Minutes of Exercise|After baseline vital signs and ECG are recorded, patients will be asked to perform a baseline standardized (modified Bruce) exercise protocol. Heart rate will be recorded during each stage of the exercise protocol. Patients will be asked to exercise to sub-maximal exertion. After the baseline exercise protocol, patients will be given a single dose of oral atenolol. After a two hour waiting period to allow for peak effect of atenolol, patients will repeat the exercise protocol. The primary study outcome measure will be the difference in pre- and post-atenolol ventricular rate response to exercise. The primary outcome measure will be compared in patients with various polymorphisms in genes that might play a role in the inter-individual response to atenolol.|after 5minutes of exercise||||beats per minute||95% Confidence Interval|Mean
2644419|NCT01719224|Secondary|Minimum Upper Airway Cross-sectional Area: to Elucidate the Anatomical and Physiological Risk Factors That Contribute to the Upper Airway Obstruction in Post-partum Patients|Each patient underwent measurements of upper airway CSA during daytime within 48 h after delivery. The minimum upper airway CSA was measured using acoustic pharyngometry (Eccovision Acoustic Pharyngometry; Sleep Group Solutions, Inc) in sitting, 45° elevated, and nonelevated upper body position.|48 hours after delivery||||cm^2||Standard Deviation|Mean
2644420|NCT01719224|Primary|Apnea-hypopnea Index (AHI), Defined as the Number of Apneas and Hypopneas Per Hour of Sleep|We conduct polysomnography in non-elevated and 45 degrees elevated body position, to show the effect of body position in context of sleep disordered breathing.We collect data of the apnea-hypopnea-index, central apneas, obstructive apneas and oxygen.|48 hours after delivery|55 women (older than 18 years) were recruited within 48 h after delivery. Polysomnography (PSG) was performed throughout the entire study night. Within a crossover design, patients were randomly assigned to receive first either nonelevated or 45° elevated upper body position. Position was changed after 3.5 h by a member of the team.|||Apneas and hypopneas per hour of sleep||Standard Error|Mean
2644421|NCT01719172|Secondary|Median Time to Achieve Hemostasis|Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (Day 0)||||Minutes||95% Confidence Interval|Median
2644422|NCT01719172|Secondary|Proportion of Subjects Who Achieve Hemostasis Within 1 Minute|Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (Day 0)||||participants|||Number
2644423|NCT01719172|Primary|Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment|Success will be defined as hemostasis obtained within 5 minutes. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.|Intra-operative (Day 0)||||participants|||Number
2644424|NCT01719003|Secondary|Body Weight Change From Baseline at Week 24|"Change from baseline in body weight (kg) after 24 weeks of treatment. Baseline refers to the last observation before the start of any randomised trial treatment. medication. Means presented are the adjusted means."|baseline and 24 weeks|FAS observed cases (OC) (Only patients with available data are analysed)|||kg||Standard Error|Mean
2644425|NCT01719003|Secondary|FPG (Fasting Plasma Glucose) Change From Baseline at Week 24|"Change from baseline in FPG (mg/dL) after 24 weeks of treatment. Baseline refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means."|baseline and 24 weeks|FAS observed cases (OC) (Only patients with available data are analysed)|||mg/dL||Standard Error|Mean
2644426|NCT01719003|Primary|HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 24|"Change from baseline in HbA1c (%) after 24 weeks of treatment. Baseline refers to the last observation before the start of any randomised trial treatment medication. Means presented are the adjusted means"|baseline and 24 weeks|FAS observed cases (OC) (Only patients with available data are analysed)|||percentage of HbA1c||Standard Error|Mean
2644427|NCT01718691|Secondary|Laboratory Test Abnormalities (Hematology Tests)|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE|up to 30 weeks||||participants|||Number
2644428|NCT01718691|Secondary|Laboratory Test Abnormalities (Biochemical Tests)|Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. Grade 1 : mild Grade 2 : moderate Grade 3 : severe or medically significant but not immediately life-threatening Grade 4 : life threatening or disabling Grade 5 : death related to AE|up to 30 weeks||||participants|||Number
2644429|NCT01718691|Secondary|Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Discontinuation Due to Adverse Event|Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA) Ver.16.1.|up to 30 weeks||||participants|||Number
2644430|NCT01718691|Secondary|Overall Survival (OS)|Death due to any given cause was defined as an event. OS was calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood's formula.|Up to 30 weeks||||days||95% Confidence Interval|Median
2646320|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 1 to Day 28) for Astma Symptom Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)|Full Analysis set|||Asthma symptom free days||90% Confidence Interval|Least Squares Mean
2644431|NCT01718691|Secondary|Duration of Response (DOR)|"DOR is the period from the date of achieving CR, CRu or PR in the responders to the earliest onset date of any progression events calculated using the Kaplan-Meier estimator. The median and the 95% CI were calculated using Greenwood's formula.~The date of achieving CR, CRu or PR was determined based on the overall response assessed using IWRC. The date of progression was determined based on overall response assessed using IWRC, Revised RC and WHO, and assessment by the primary physicians (excluding overall response).~Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause."|Up to 30 weeks||||days||95% Confidence Interval|Median
2644432|NCT01718691|Secondary|Progression-Free Survival (PFS)|"PFS is the period from registration date to the earliest onset date of any progression event calculated using the Kaplan-Meier estimator. The median and the 95% confidence interval (CI) were calculated using Greenwood's formula.~Progression event was defined as progression (includes recurrence/relapse), initiation of post-study treatment, confirmation of other malignant tumor, or death due to any given cause. The date of progression was determined based on overall response assessed using IWRC, Revised RC, and WHO, and assessment by the primary physicians (excluding overall response)."|Up to 30 weeks||||days||95% Confidence Interval|Median
2644433|NCT01718691|Secondary|"Overall Response Rate (PR or Better) Based on WHO Handbook for Reporting Results of Cancer Treatment (1979)"|"The criteria for Overall response rate (PR or better) based on WHO Handbook for Reporting Results of Cancer Treatment (1979) are shown below.~Definition of PR:~Measurable disease:~50% or more decrease in total tumor size of the lesions which have been measured to determine the effect of therapy by 2 observations not less than 4 weeks apart. In addition there can be no appearance of new lesions or progression of any lesion.~Unmeasurable disease:~Estimated decrease in tumor size of 50% or more for at least 4 weeks.~Bone metastases:~Partial decrease in size of lytic lesions, recalcification of lytic lesions, or decreased density of blastic lesions for at least 4 weeks."|Up to 30 weeks||||percentage of participants|||Number
2644434|NCT01718691|Secondary|Complete Response Rate Based on WHO Handbook for Reporting Results of Cancer Treatment (1979)|"The criteria for Complete response based on WHO Handbook for Reporting Results of Cancer Treatment (1979) are shown below.~Measurable disease:~The disappearance of all known disease, determined by 2 observations not less than 4 weeks apart.~Unmeasurable disease:~Complete disappearance of all known disease for at least 4 weeks.~Bone metastases:~Complete disappearance of all lesions on X-ray or scan for at least 4 weeks."|Up to 30 weeks||||percentage of participants|||Number
2644435|NCT01718691|Secondary|Overall Response Rate (PR or Better) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)|"The criteria for PR based on the Revised RC are shown below.~Definition: Regression of measurable disease and no new sites~Nodal Masses:~50% or more decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes~FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site~Variably FDG-avid or PET negative; regression on CT~Spleen, Liver:~50% or more decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen~Bone Marrow:~Irrelevant if positive prior to therapy; cell type should be specified."|Up to 30 weeks||||percentage of participants|||Number
2644436|NCT01718691|Secondary|Complete Response Rate (CR) Based on Revised Response Criteria for Malignant Lymphoma (2007)(Revised RC)|"The criteria for CR based on the Revised RC are shown below.~Definition: Disappearance of all evidence of disease~Nodal Masses:~[18F]fluorodeoxyglucose (FDG)-avid or PET positive prior to therapy; mass of any size permitted if PET negative.~Variably FDG-avid or PET negative; regression to normal size on CT.~Spleen, Liver:~Not palpable, nodules disappeared~Bone Marrow:~Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative."|Up to 30 weeks||||percentage of participants|||Number
2644437|NCT01718691|Secondary|Overall Response Rate (Antitumor Effect: PR or Better) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)|"The criteria for PR based on IWRC are shown below.~PR: SPD regressed > 50%"|Up to 30 weeks||||percentage of participants|||Number
2644438|NCT01718691|Primary|Complete Response Rate (CR + CRu) Based on International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas (1999)(IWRC)|"The criteria for CR and CRu based on IWRC are shown below.~CR: Fulfills all of the following~Disappearance of all detectable disease~LN* > 1.5 cm must decrease to ≤ 1.5 cm~CRu: Fulfills all of the following~LN >1.5 cm; SPD** decrease >75%~indeterminate bone marrow~LN: lymph nodes or nodal masses ** SPD: sum of the products of the greatest diameters"|Up to 30 weeks||||percentage of participants|||Number
2644439|NCT01718535|Primary|Percent Agreement|The study will pass if the percent agreement is ≥ 99.0% and the lower bound of a 1-sided 95% confidence interval is ≥ 95.0% using the score method.|After second pass result is complete (~3hours)||||Percent Agreement||95% Confidence Interval|Number
2644440|NCT01718522|Secondary|Interstitial Sensor Glucose Excursions After Meals (Amplitude of Excursions) at Baseline and 3 Months||Baseline and 3 months|Meals were not adequately documented, so that a meaningful analysis was not possible||||||
2644441|NCT01718522|Secondary|Number of Automatic Low Glucose Suspend (LGS) Activations in Nighttime (22:00 - 6:00 Hrs) at Baseline and 3 Months||Baseline and 3 months||||activations/patient/sensor day||Standard Deviation|Mean
2644442|NCT01718522|Secondary|Number of Automatic Low Glucose Suspend (LGS) Activations in Daytime (6:00 - 22:00 Hrs) at Baseline and 3 Months||Baseline and 3 months||||activations/patient/sensor day||Standard Deviation|Mean
2644443|NCT01718522|Secondary|Time in Hyperglycemic Region Per Sensor Day at Baseline and 3 Months||Baseline and 3 months||||min/sensor day||Standard Deviation|Mean
2644444|NCT01718522|Secondary|Area Under the Curve (AUC) in Hyperglycemic Region (>140mg/dl) at Baseline and 3 Months|Area under the curve (AUC) in hyperglycemic region (>140mg/dl) at baseline (1 month before the start of the study) and 3 months during the study.|Baseline and 3 months||||mg/dl*day||Standard Deviation|Mean
2644445|NCT01718522|Secondary|Area Under the Curve (AUC) in Hypoglycemic Region (< 70mg/dl) at Baseline and 3 Months|Area under the curve (AUC) in hypoglycemic region (< 70mg/dl) at baseline (1 month before the start of the study) and 3 months during the study.|Baseline and 3 months||||mg/dl*day||Standard Deviation|Mean
2644446|NCT01718522|Secondary|Sensor Wearing Time (Sensor Days/Calendar Week) at Baseline and 3 Months||Baseline and 3 months||||sensor days/calendar week||Standard Deviation|Mean
2644447|NCT01718522|Secondary|Interstitial Sensor Glucose Concentration (mg/dl) at Baseline and 3 Months||Baseline and 3 months||||mg/dl||Standard Deviation|Mean
2644451|NCT01718509|Secondary|Amphetamine Cessation Symptom Assessment (ACSA) Total Score|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Up to 12 weeks|Safety Analysis Set|||units on a scale||Standard Deviation|Mean
2644452|NCT01718509|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Up to 12 weeks|Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. All subjects from Site 015 were excluded from the Safety Analysis Set.|||participants|||Number
2644453|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression||Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||percentage of participants|||Number
2644454|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort||Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||percentage of participants|||Number
2644455|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities||Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||percentage of participants|||Number
2644456|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care||Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||percentage of participants|||Number
2644457|NCT01718509|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.|Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||percentage of participants|||Number
2644458|NCT01718509|Secondary|Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks|"The FrSBe is a 46-item self-rating scale designed to measure the neurobehavioral traits associated with the 3 primary regions of the prefrontal cortex. Subjects were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from 1 (almost never) to 5 (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement."|Baseline and up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||t-scores||Standard Error|Least Squares Mean
2644459|NCT01718509|Secondary|Change From Baseline in Binge Eating Scale (BES) Score at Week 12|The BES is a self-reported questionnaire containing 16 items designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. Each item is assessed based on 1 of 4 responses, with 1 denoting that a subject has greater control over eating behavior and 4 denoting that a subject had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.|Baseline and week 12|Full Analysis Set.|||units on a scale||Standard Error|Least Squares Mean
2644460|NCT01718509|Secondary|Change From Baseline in Eating Inventory Scores at Week 12|There are 36 true/false items, 14 items on a 4-point Likert scale (1=eat rarely to 4=always), and 1 item on a 6-point Likert scale (1=eat whatever you want to 6=constantly limiting food intake). Cognitive Restraint score ranges from 0-21. Hunger score ranges from 0-14. Disinhibition score ranges from 0-16. Higher scores denote higher levels of restrained eating, disinhibited eating and predisposition to hunger.|Baseline and week 12|Full Analysis Set.|||units on a scale||Standard Error|Least Squares Mean
2644461|NCT01718509|Secondary|Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12||Baseline and Visit 8 Which Spans Weeks 11/12|Full Analysis Set.|||Binge episodes per week||Standard Error|Least Squares Mean
2644462|NCT01718509|Secondary|Binge Eating Response|"Response is based on the reduction in the number of binge eating episodes. Responses were categorized as follows:~1-week Cessation = 100% reduction in binge episodes during the preceding 7 days~Marked Reduction = 99% to 75% reduction during the time since the previous visit~Moderate Reduction = 74% to 50% reduction during the time since the previous visit~Negative to Minimal Reduction = <50% reduction during the time since the previous visit"|Up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||percentage of participants|||Number
2644463|NCT01718509|Secondary|Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks||Baseline and up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||Percent||Standard Error|Least Squares Mean
2644464|NCT01718509|Secondary|Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks||Baseline and up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||mmol/L||Standard Error|Least Squares Mean
2644465|NCT01718509|Secondary|Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks||Baseline and up to 12 weeks|Full Analysis Set. Not all subjects had data for this outcome.|||mmol/L||Standard Error|Least Squares Mean
2644466|NCT01718509|Secondary|Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12|The Y-BOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. Reduction in total score indicates improvement.|Baseline and week 12|Full Analysis Set.|||units on a scale||Standard Error|Least Squares Mean
2644467|NCT01718509|Secondary|Percent Change From Baseline in Body Weight (kg) at Week 12||Baseline and week 12|Full Analysis Set.|||percentage change||Standard Error|Least Squares Mean
2644468|NCT01718509|Secondary|Percent of Participants With a 4-Week Cessation From Binge Eating|4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.|Up to 12 weeks|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2646339|NCT01704495|Secondary|Rate of Asthma-specific Hospital Admission/Intensive Care Unit Admissions During 6 Months||From start of treatment up to 6 months||||Exacerbations per 6 month||90% Confidence Interval|Least Squares Mean
2644469|NCT01718509|Secondary|Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 12 weeks|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2644470|NCT01718509|Primary|Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12|Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary.|Baseline and Visit 8 Which Spans Weeks 11/12|The Full Analysis Set was defined as all randomized subjects who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (i.e., number of binge days per week calculated for at least 1 week).|||Binge days per week||Standard Error|Least Squares Mean
2644471|NCT01718483|Secondary|Amphetamine Cessation Symptom Assessment (ACSA) Total Score|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Up to 12 weeks|The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Not all participants had data for this outcome.|||units on a scale||Standard Deviation|Mean
2644472|NCT01718483|Secondary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale. Number of participants with suicidal ideation and suicidal behavior were reported.|Up to 12 weeks|The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Not all participants had data for this outcome.|||participants|||Number
2644473|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various anxiety/depression conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||percentage of participants|||Number
2644474|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various pain/discomfort conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||percentage of participants|||Number
2644475|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various usual activities conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||percentage of participants|||Number
2644476|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various self-care conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||percentage of participants|||Number
2644477|NCT01718483|Secondary|EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Percentage of participants with various mobility conditions were reported.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||percentage of participants|||Number
2644478|NCT01718483|Secondary|Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Week 12|"The FrSBe is a 46-item self-rating scale designed to measure the neurobehavioral traits associated with the 3 primary regions of the prefrontal cortex. Participants were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from 1 (almost never) to 5 (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement."|Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||t-scores||Standard Error|Least Squares Mean
2644479|NCT01718483|Secondary|Change From Baseline in Binge Eating Scale (BES) Score at Week 12|The BES is a self-reported questionnaire containing 16 items designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. Each item is assessed based on 1 of 4 responses, with 1 denoting that a participant has greater control over eating behavior and 4 denoting that a participant had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.|Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||units on a scale||Standard Error|Least Squares Mean
2644480|NCT01718483|Secondary|Change From Baseline in Eating Inventory Scores at Week 12|"The Eating Inventory also known as the Three-Factor Eating Questionnaire is a 51-item self-reported questionnaire intended to assess 3 dimensions of eating behavior. There are 36 true/false items, 14 items on a 4-point Likert scale (1=eat rarely to 4=always), and 1 item on a 6-point Likert scale (1=eat whatever you want to 6=constantly limiting food intake).~Cognitive Restraint score ranges from 0-21. Hunger score ranges from 0-14. Disinhibition score ranges from 0-16. Higher scores denote higher levels of restrained eating, disinhibited eating and predisposition to hunger."|Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||units on a scale||Standard Error|Least Squares Mean
2644481|NCT01718483|Secondary|Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 (Weeks 11-12)||Baseline and Visit 8 (Weeks 11-12)|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).|||Binge episodes per week||Standard Error|Least Squares Mean
2644482|NCT01718483|Secondary|Binge Eating Response|"Response is based on the reduction in the number of binge eating episodes. Percentage of participants with response was reported. Responses were categorized as follows:~1-week Cessation = 100% reduction in binge episodes during the preceding 7 days.~Marked Reduction = 99% to 75% reduction during the time since the previous visit.~Moderate Reduction = 74% to 50% reduction during the time since the previous visit.~Negative to Minimal Reduction = <50% reduction during the time since the previous visit."|Week 12/ET|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||percentage of participants|||Number
2644483|NCT01718483|Secondary|Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks||Baseline and Week 12/ET|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||Percent hemoglobin||Standard Error|Least Squares Mean
2644484|NCT01718483|Secondary|Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks||Baseline and Week 12/ET|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||mmol/L||Standard Error|Least Squares Mean
2644485|NCT01718483|Secondary|Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks||Baseline and Week 12/Early termination (ET)|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
2644486|NCT01718483|Secondary|Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12|The Y-BOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. Reduction in total score indicates improvement.|Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.|||units on a scale||Standard Error|Least Squares Mean
2644487|NCT01718483|Secondary|Percent Change From Baseline in Body Weight at Week 12||Baseline and Week 12|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).|||percent change||Standard Error|Least Squares Mean
2644488|NCT01718483|Secondary|Percentage of Participants With a 4-Week Cessation From Binge Eating|4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).|||percentage of participants||95% Confidence Interval|Number
2644489|NCT01718483|Secondary|Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores|CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 12 weeks|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).|||percentage of participants||95% Confidence Interval|Number
2644511|NCT01717989|Secondary|Percentage of Participants Receiving a Vitamin D Sterol|The percentage of participants receiving a vitamin D sterol (ie, calcitriol, alfacalcidol, paricalcitol or doxercalciferol) over time. Note that participants could receive more than one type of vitamin D sterol.|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point|||percentage of participants|||Number
2644490|NCT01718483|Primary|Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12)|Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary.|Baseline and Visit 8 (Weeks 11-12)|The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).|||Binge days per week||Standard Error|Least Squares Mean
2644491|NCT01718353|Primary|Drug-target Engagement in CTCs: Change From Baseline at Cycle 1 Day 8 in MTB by Categories of PSA Decrease From Baseline (≥30%, Not ≥30%) After Cycle 4|Analysis of CTCs is a co-primary endpoint. Growth of prostate cancer cells is dependent on sustained AR nuclear signaling. Taxanes (e.g., docetaxel and cabazitaxel) may mediate some of their activity in prostate cancer by impairing AR trafficking along the microtubules from the tumor cell cytoplasm into the nucleus, as a result of taxane-induced MTB. Blood samples were collected at baseline and post-treatment to allow isolation of CTCs, which were evaluated for tumor cell biomarker measures %ARNL and MTB score. MTB in images of CTCs captured by GEDI was qualitatively assessed by three independent operators for increase compared with baseline on a scale of 0 to 3 from no to most MTB increase. Increase from baseline in MTB may indicate inhibition of AR signaling. Change from baseline in MTB at Cycle 1 Day 8 is summarized by categories of participants with PSA decrease from baseline (≥30%, Not ≥30%) after Cycle 4.|Baseline and Cycle 1 Day 8, Cycle 4|Participants with evaluable CTCs at both baseline and Cycle 1 Day 8, and evaluable PSA result at both baseline and Cycle 4|||units on a scale||Standard Deviation|Mean
2644492|NCT01718353|Secondary|Percentage of Participants With ≥30% and ≥50% Reduction in PSA Response|Participants with ≥30% and ≥50% reduction in PSA response from base line were evaluated in participants who were previously treated with a high potency androgen receptor (AR)-targeted agent (AR signaling inhibitor or cytochrome P450 17 alphahydroxylase/17,20lyase [CYP 17] inhibitor).|From baseline until DP or study cut-off, whichever was earlier (Maximum duration: 60 weeks)|Analysis was performed on as-treated population that included all participants who received initial taxane treatment and had a post treatment assessment. Number of participants analyzed=participants treated/non-treated with AR-target agent and with PSA response assessment at specified time-points.|||percentage of participants|||Number
2644493|NCT01718353|Secondary|Overall Survival|Overall survival before switch and overall survival during the study was defined as the time interval from the date of random allocation to the date of death due to any cause until study cut-off date.|From baseline until death due to any cause or study cut-off, whichever was earlier (Maximum duration: 60 weeks)|Analysis was performed on all randomized participants.|||Months||95% Confidence Interval|Median
2644494|NCT01718353|Secondary|Clinical Progression-free Survival (cPFS)|cPFS was assessed before switch and during the study including skeletal-related events (SRE), increasing pain requiring escalation of narcotic analgesics, urinary obstruction, etc. SRE included pathological fractures and/or spinal cord compression, need for bone irradiation (including radioisotopes or bone surgery), change of antineoplastic therapy (including introduction of bisphosphonates or denosumab in the face of increase in pain) to treat bone pain. Pain was assessed using present pain intensity (PPI) scale (0=no pain, up to 5=excruciating pain) and analgesics used for cancer pain (1 point for non-narcotic medications and 4 points for narcotic medications).|Baseline, Pre-dose every 3 weeks, EOT, every 3 months (for 1 year) until first SRE occurrence or death or study cut-off, whichever was earlier (Maximum duration: 60 weeks)|Analysis was performed on all randomized participants.|||months||95% Confidence Interval|Median
2644495|NCT01718353|Secondary|Radiographic Progression-free Survival (rPFS)||From baseline, every 12 weeks until radiological tumor progression or study cut-off, whichever was earlier (Maximum duration: 60 weeks)|Analysis was performed on all randomized participants.|||months||95% Confidence Interval|Median
2644496|NCT01718353|Secondary|Percentage of Participants With Objective Response||From baseline until DP or study cut off, whichever was earlier (Maximum duration: 60 weeks)|No data was collected to determine the Objective Response, hence this outcome measure was not evaluated.||||||
2644497|NCT01718353|Secondary|PSA Progression Free Survival|PSA progression-free survival before any switch and PSA progression free survival during the study was defined as the time interval between the date of Day 1 of Cycle 1 to the date of either first PSA progression or death due to any cause whichever came first. PSA progression was defined as decline of PSA from baseline (an increase of ≥25% [at least 2ng/mL] over the nadir value, confirmed by a second PSA value at least 3 weeks apart) and no decline of PSA from baseline (an increase of ≥25% [at least 2ng/mL] over the baseline value after 12 weeks of treatment, confirmed by a second PSA value at least 3 weeks apart).|From Baseline until DP or death due to any cause or study cut off date, whichever was earlier (Maximum duration: 60 weeks)|Analysis was performed on all randomized population.|||months||95% Confidence Interval|Median
2644498|NCT01718353|Secondary|Progression Free Survival (PFS)|PFS was defined as the time interval between the date of random allocation of the treatment and the date of first documentation of any of the following: radiographic tumor progression (using Modified Response Evaluation Criteria in Solid Tumors [RECIST1.1] before any switch and during the study), clinical progression (including skeletal-related events, increasing pain requiring escalation of narcotic analgesics, urinary obstruction), PSA progression or death from any cause. Analysis was performed by Kaplan Meier method.|From Baseline until DP or death due to any cause or study cut off, whichever was earlier (Maximum duration: 60 weeks)|Analysis was performed on all randomized participants.|||months||95% Confidence Interval|Median
2644509|NCT01717989|Secondary|Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time|Facilities were categorized over time based on the percentage of participants at the facility with hemoglobin < 10 g/dL: Faciities with 0 to <5% of participants with hemoglobin < 10 g/dL; Facilities with 5 to < 10% of participants with hemoglobin < 10 g/dL; Facilities with 10 to < 15% participants with hemoglobin < 10 g/dL; Facilities with 15 to < 20% of participants with hemoglobin < 10 g/dL; Facilities with ≥ 20% of participants with hemoglobin < 10 g/dL.|December 2010, March 2011, June 2011, September 2011, December 2011|Facilities with at least one non-missing hemoglobin record, for participants included in the primary analysis set who were on study and with available data at each time point.|||percentage of facilities|Participants||Number
2644510|NCT01717989|Secondary|Mean Hemoglobin Concentration by Quarter||Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point and with available data.|||g/dL||Standard Deviation|Mean
2644499|NCT01718353|Primary|Drug-target Engagement in Circulating Tumor Cells (CTCs): Change From Baseline at Cycle 1 Day 8 in Percent Androgen Receptor Nuclear Localization (%ARNL) by Categories of PSA Decrease From Baseline (≥50%, Not ≥50%) After Cycle 4|Analysis of CTCs is a co-primary endpoint. Growth of prostate cancer cells is dependent on sustained androgen receptor (AR) nuclear signaling. Taxanes (e.g., docetaxel and cabazitaxel) may mediate some of their activity in prostate cancer by impairing AR trafficking along the microtubules from the tumor cell cytoplasm into the nucleus, as a result of taxane-induced microtubule bundling (MTB). Blood samples were collected at baseline and post-treatment to allow isolation of CTCs, which were evaluated for tumor cell biomarker measures %ARNL and MTB score. %ARNL was assessed by quantitative analysis of images of CTCs captured by geometrically enhanced differential immunocapture (GEDI). Reduction from baseline in %ARNL (percentage of total cellular AR that is located in the nucleus) may indicate inhibition of AR signaling. Change from baseline in %ARNL at Cycle 1 Day 8 is summarized by categories of participants with PSA decrease from baseline (≥50%, Not ≥50%) after Cycle 4.|Baseline and Cycle 1 Day 8, Cycle 4|Participants with evaluable CTCs at both baseline and Cycle 1 Day 8, and evaluable PSA result at both baseline and Cycle 4|||percentage ARNL||Standard Deviation|Mean
2644500|NCT01718353|Primary|Percentage of Participants With PSA Response|PSA response was defined as ≥50% decrease in PSA levels in both treatment arms from baseline, during the whole treatment, before treatment switch and after treatment switch. PSA progression was defined as decline of PSA from baseline (an increase of ≥25% [at least 2ng/ml] over the nadir value, confirmed by a second PSA value at least 3 weeks apart) and no decline of PSA from baseline (an increase of ≥25% [at least 2ng/ml] over the baseline value after 12 weeks of treatment, confirmed by a second PSA value at least 3 weeks apart). Because the purpose of this study is to explore the benefit of a regimen in which participants are switched to a different taxane if PSA does not decrease ≥30% after 4 cycles, irrespective of which agent (docetaxel or cabazitaxel) is administered initially, the data for participants who began treatment with docetaxel and for those who began treatment with cabazitaxel were combined for the efficacy analyses.|Baseline, Pre-dose every 3 weeks, 30 days after last treatment administration (End of treatment [EOT]), every 3 months (for 1 year) then every 6 months until PSA progression or study cut-off, whichever was earlier (Maximum duration: 60 weeks)|Analysis was performed on all randomized participants.|||percentage of participants|||Number
2644501|NCT01718028|Secondary|Percent Change From Baseline in NITFBUT by Visit|NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. The percentage of participants with a lengthening in tear film break up time relative to baseline is reported. A positive value indicates an improvement in film stability, which may improve dry eye symptoms in dry eye sufferers.|Baseline (Day 0), Day 14, Day 30|Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit|||percent change||Standard Deviation|Mean
2644502|NCT01718028|Secondary|Mean NITFBUT by Visit|NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A longer tear film break-up time indicates a more stable tear film, which may improve dry eye symptoms in dry eye sufferers.|Baseline (Day 0), Day 14, Day 30|Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit|||seconds||Standard Deviation|Mean
2644503|NCT01718028|Secondary|Mean Change From Baseline in NITFBUT at Day 14|NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.|Baseline (Day 0), Day 14|Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit|||seconds||Standard Deviation|Mean
2644504|NCT01718028|Primary|Mean Change From Baseline in NITFBUT at Day 30|NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.|Baseline (Day 0), Day 30|Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit|||seconds||Standard Deviation|Mean
2644505|NCT01717989|Secondary|Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out||June to December 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point|||participants|||Number
2644506|NCT01717989|Secondary|Number of Participants Taking Epoetin Alfa by Month|The number of participants who took epoetin alfa only, by month, in participants on hemodialysis.|December 2010, March 2011, June 2011, September 2011, December 2011|Primary Analysis Set participants on study and on hemodialysis at each time point.|||participants|||Number
2644507|NCT01717989|Secondary|Cumulative Monthly Dose of Epoetin Alfa Administered|The cumulative monthly intravenous epoetin alfa dose in participants on hemodialysis.|December 2010, March 2011, June 2011, September 2011, December 2011|Primary Analysis Set participants on study and on hemodialysis and receiving epoetin alfa at each time point and with available data.|||units||Inter-Quartile Range|Median
2644508|NCT01717989|Secondary|Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL|The mean percentage of participants per facility with transferrin saturation < 20% and ferritin level < 100 ng/mL. Mean and CI are calculated across facilities and by using number of participants with non-missing transferrin saturation and ferritin in each facility as weight.|December 2010, March 2011, June 2011, September 2011, December 2011|Facilities / participants with at least one non-missing transferrin saturation or ferritin record at each time point.|||percentage of participants per facility|Participants|95% Confidence Interval|Mean
2644556|NCT01717742|Secondary|Number of Participants With Serious Bleeding|Number of Participants who had intrapleural bleeding resulting in a drop in hemoglobin of greater than 20 g/L or needing a transfusion.|up to 4 months||||Participants|||Count of Participants
2644512|NCT01717989|Secondary|Percentage of Participants Receiving Phosphate Binding Agents|The percentage of participants receiving phosphate binding agents over time|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point|||percentage of participants|||Number
2644513|NCT01717989|Secondary|Percentage of Participants Receiving Cinacalcet|The percentage of participants receiving cinacalcet (Sensipar) over time|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point|||percentage of participants|||Number
2644514|NCT01717989|Secondary|Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA)|The percentage of participants who received erythropoietin stimulation agents (ESA) in a facility over the course of the study. Mean and confidence interval (CI) are calculated across facilities and by using total number of participants actively receiving chronic dialysis in each facility per month as weight.|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set facilities / participants on study at each time point.|||percentage of participants per facility|Participants|95% Confidence Interval|Mean
2644515|NCT01717989|Secondary|Percentage of Participants in Each Vascular Access Type Category|The percentage of participants in each vascular access type category out of all enrolled participants on hemodialysis over the course of the study.|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study and on hemodialysis at each time point|||percentage of participants|||Number
2644516|NCT01717989|Primary|Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%|"The percentage of participants within each small dialysis organization (SDO) facility with a urea reduction ratio ≥ 65% over time. URR is calculated as:~Baseline urea level - post-baseline urea level/baseline urea level * 100. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility."|Data were collected monthly from June 2010 until September 2012|Facilities with at least one non-missing URR record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).|||percentage of participants per facility|Participants|95% Confidence Interval|Mean
2644517|NCT01717989|Primary|Percentage of Participants Per Facility With Hemoglobin > 12 g/dL|The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin > 12 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.|Data were collected monthly from June 2010 until September 2012|Facilities with at least one non-missing hemoglobin record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).|||percentage of participants per facility|Participants|95% Confidence Interval|Mean
2644518|NCT01717989|Secondary|Percentage of Participants Treated by Each Dialysis Modality|The percentage of participants treated with peritoneal, hemodialysis (in center) or home hemodialysis over the course of the study. For participants who switched modalities within a quarter, the last current modality is reported.|Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.|Primary Analysis Set participants on study at each time point|||percentage of participants|||Number
2644519|NCT01717989|Primary|Percentage of Participants Per Facility With Hemoglobin < 10 g/dL|The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin < 10 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.|Data were collected monthly from June 2010 until September 2012|Facilities with at least one non-missing hemoglobin record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).|||percentage of participants per facility|Participants|95% Confidence Interval|Mean
2644520|NCT01717976|Secondary|Total Costs to the VHA|Assessment of VA and VA purchased care costs in 2016 dollars within 180 days from emergency department visit|180 days|0 out of 257 participants in the DISPO intervention group and 1 of 256 in the usual care group were deceased at 30 days and not included in the cost analysis.|||US Dollars||Standard Deviation|Mean
2644521|NCT01717976|Secondary|Number of Participants Satisfied With Health Care|Satisfaction with health care determined by 9 or 10 on the CAHPS|180 days|26 out of 257 in intervention group and 33 out of 256 participants in the usual care group had missing data at the 180 day interview for satisfaction due to missing the 180-day interview or non-response to the satisfaction question at the 180 day interview.|||Participants|||Count of Participants
2644522|NCT01717976|Secondary|Number of Participants Satisfied With Health Care|Satisfaction with health care determined by 9 or 10 on the CAHPS|30 days|24 out of 257 in intervention group and 38 out of 256 participants in the usual care group had missing data at the 30 day interview for satisfaction due to missing the 30-day interview or non-response to the satisfaction question at the 30 day interview.|||Participants|||Count of Participants
2644523|NCT01717976|Secondary|Number of Participants Satisfied With Health Care|Satisfaction with health care determined by 9 or 10 on the CAHPS|Baseline|0 out of 257 in intervention group and 2 out of 256 participants in the usual care group had missing data at baseline for satisfaction due to non-response.|||Participants|||Count of Participants
2644524|NCT01717976|Primary|Number of Participants Experiencing Repeat ED Use|Number of Participants Experiencing Repeat ED Use|30 days|0 out of the 257 participants in the DISPO intervention group and 1 of the 256 participants in the Usual Care group were deceased at 30 days and not included in the primary outcome analysis.|||Participants|||Count of Participants
2644525|NCT01717898|Other Pre-specified|Determination of Whether Specific Pathway Changes Are Predictive of Clinical Benefit (Improved PFS) or Resistance Prior to Treatment or During Treatment Using Microarray Analysis.||post study|||||||
2644526|NCT01717898|Other Pre-specified|Determination of Whether the Pre-treatment Status of pS6, pAKT, p4EBP1 and PTEN, Determined by IHC in the Optional Biopsies of Metastatic Tumors, Are Associated With Response to BEZ235 Plus Abiraterone Acetate/Prednisone.||post study|||||||
2644527|NCT01717898|Secondary|Safety of BEZ235 and Abiraterone Acetate Plus Prednisone When Used in Combination|Number of reported Adverse Events in BEZ235 and Abiraterone Acetate plus Prednisone when used in combination (Phase II).|Beginning of Phase II up to 15 months|No Adverse Events were collected in Phase II. Study was terminated during Phase I, Dose level 1 due to toxicity.||||||
2644528|NCT01717898|Secondary|Objective Response Rate (ORR) in Phase II|Proportion of patients achieving an objective response to BEZ235 + Abiraterone Acetate/prednisone according to RECIST criteria.|From beginning of Phase II up to 15 months|ORR could not be determined. Study was terminated during Phase I, Dose level 1 due to toxicity.||||||
2644529|NCT01717898|Secondary|Determination of the Time to PSA Progression in Phase II|Determination of the time to PSA progression in Phase II based on PSAWG2 criteria.|Beginning of Phase II up to 15 months|Time to PSA progression could not be determined. Study was terminated during Phase I, Dose level 1 due to toxicity.||||||
2644530|NCT01717898|Secondary|Progression Free Survival (PFS) in Phase II|Progression Free Survival (PFS) of the combination of BEZ235 plus Abiraterone Acetate/prednisone as determined by Prostate-Specific Antigen Working Group 2 criteria (PSAWG2 ) during Phase II.|Beginning of Phase II up to 15 months|PFS in Phase II could not be determined. Study was terminated during Phase I, Dose level 1 due to toxicity.||||||
2644531|NCT01717898|Secondary|Trough Concentrations of BEZ235 and Abiraterone Acetate Plus Prednisone When Used in Combination|Trough concentrations of BEZ235 and Abiraterone Acetate plus Prednisone when used in combination during Phase I.|Beginning of study up to 15 months|Concentrations could not be determined. Study was terminated during Phase I, Dose level 1 due to toxicity.||||||
2644532|NCT01717898|Primary|Maximum Tolerated Dose for BEZ235 + Abiraterone Acetate (Phase I).|Maximum Tolerated Dose (MTD) for BEZ235 + Abiraterone Acetate (to be determined during Phase I). The MTD of BEZ235 will be the dose when given in combination results in less than 33% dose limiting toxicities (DLT).|Beginning of study up to 15 months|Dose could not be determined. Study was terminated during Phase I, Dose level 1 due to toxicity.|||Participants|||Count of Participants
2644533|NCT01717898|Primary|Response Proportion as Defined by a Decline in PSA of > 50%|"Response proportion as defined by a decline in PSA of > 50% following 12 weeks of therapy for patients treated with the combination of BEZ235 and Abiraterone Acetate plus Prednisone (Phase II outcome measure).~Study was terminated during Phase I, Dose level 1 due to toxicity, therefore no Phase II data is available."|From day 1 of therapy initiation up to 12 weeks|Study was terminated during Phase I, Dose level 1 due to toxicity.||||||
2644534|NCT01717898|Primary|Anti-tumor Responses as Defined by a Decline in PSA of > 50%|Anti-tumor responses as defined by a decline in PSA of > 50% following 12 weeks of therapy to the combination of Abiraterone Acetate plus BEZ-235 occur in a cohort of patients who have received prior therapy with Abiraterone Acetate therapy|From day 1 of therapy initiation up to 12 weeks|Study was terminated during Phase I, Dose level 1 due to toxicity.|||Participants|||Count of Participants
2644535|NCT01717898|Primary|Number of Reported Dose Limiting Toxicities When Combining BEZ235 With Abiraterone Acetate (Phase I).||Beginning of study up to 15 months|Study was terminated during Phase I, Dose level 1 due to toxicity.|||Participants|||Count of Participants
2644536|NCT01717872|Secondary|Percent of Glottic Opening With the MAC Blade Lifting the Tongue and the Epiglottis|The MAC blade was inserted under the tongue to view the percent glottic opening and compared with the view with the same blade lifting the epiglottis to view the percent glottic opening.|30 seconds||||percent of glottic opening||95% Confidence Interval|Mean
2644537|NCT01717872|Secondary|Percent of Glottic Opening With the Miller Blade Lifting the Epiglottis and Tongue|Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the same blade lifting the tongue|30 seconds||||percent of glottic opening||95% Confidence Interval|Mean
2644538|NCT01717872|Primary|The View of the Larynx (Glottis Opening) as Determined by POGO Score (Percentage of Glottic Opening).|Percent of glottic opening (POGO) with the Miller blade lifting the epiglottis compared with the score with the Macintosh blade lifting the tongue|30 seconds||||percentage of Glottic opening||95% Confidence Interval|Mean
2644539|NCT01717859|Secondary|Baseline to Month 6 Change in CDAI|"28 joints will be evaluated for TJC and SJC as well as patient and physician global values assessed at the time of each visit. Change scores are calculated by subtracting Baseline minus 6 Month CDAI scores.~The scale being used is called the Clinical Disease Activity Index (CDAI) and has a range of 0 to 76. Values of CDAI below 2.8 imply remission, below 10 imply low disease activity, below 22 imply moderate disease activity, and above 22 implies high disease activity."|Baseline, 6 Month||||units on a scale||Standard Deviation|Mean
2644540|NCT01717859|Secondary|Baseline to Month 3 Change in CDAI|"28 joints will be evaluated for TJC and SJC as well as patient and physician global values assessed at the time of each visit. Change scores are calculated by subtracting Baseline minus 3 Month CDAI scores.~The scale being used is called the Clinical Disease Activity Index (CDAI) and has a range of 0 to 76. Values of CDAI below 2.8 imply remission, below 10 imply low disease activity, below 22 imply moderate disease activity, and above 22 implies high disease activity."|Baseline, 3 month||||units on a scale||Standard Deviation|Mean
2644541|NCT01717859|Secondary|Baseline to Month 6 Change in DAS28/ESR|"28 joints will be evaluated for TJC and SJC as well as patient and physician global values assessed at the time of each visit, finally the ESR lab value will be included in the total calculation. Change scores are calculated by subtracting Baseline minus 6 Month DAS scores.~The scale being used is called the Disease Activity Score for 28 Joints (DAS28) using the Erythrocyte Sedimentation Rate (ESR) in the calculation rather than the C Reactive Protein (CRP). The scale ranges from 0 to 9.4. Values of DAS28 below 2.6 imply remission, below 3.2 imply low disease activity and greater than 5.1 implies active disease."|Baseline, 6 Month||||units on a scale||Standard Deviation|Mean
2644542|NCT01717859|Secondary|Baseline to Month 3 Change in DAS28/ESR|"28 joints will be evaluated for Tender Joint Count (TJC) and Swollen Joint Count (SJC) as well as patient and physician global values assessed at the time of each visit, finally the ESR lab value will be included in the total calculation. Change scores are calculated by subtracting Baseline minus 3 Month Disease Activity Score (DAS) scores.~The scale being used is called the Disease Activity Score for 28 Joints (DAS28) using the Erythrocyte Sedimentation Rate (ESR) in the calculation rather than the C Reactive Protein (CRP). The scale ranges from 0 to 9.4. Values of DAS28 below 2.6 imply remission, below 3.2 imply low disease activity and greater than 5.1 implies active disease."|Baseline, 3 month||||units on a scale||Standard Deviation|Mean
2644557|NCT01717742|Secondary|Number of Participants With Need for Ventilatory Support or Non-invasive Ventilation Following the Intervention|Number of Participants with need for any kind of ventilatory support or any kind of non-invasive ventilation right after the intervention.|up to 4 months||||Participants|||Count of Participants
2644543|NCT01717859|Secondary|Baseline to Month 6 Change in Total B-mode Synovial Hypertrophy Score of 34 Joints|"34 joints will be evaluated using a 0 to 3 point scale for each joint. Synovial hypertrophy score is the sum of all the joint scores. Change scores are calculated by subtracting Baseline minus 6 Month Synovial Hypertrophy Scores.~This scale is called the Grey Scale Synovial Hypertrophy Score (GSUS). Please note that B-mode is the same as GSUS. It ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. Therefore, a higher value of the total score for GSUS represents more severe disease level."|Baseline, 6 Month||||units on a scale||Standard Deviation|Mean
2644544|NCT01717859|Secondary|Baseline to Month 3 Change in Total B-mode Synovial Hypertrophy Score of 34 Joints|"34 joints will be evaluated using a 0 to 3 point scale for each joint. Synovial hypertrophy score is the sum of all the joint scores. Change scores are calculated by subtracting Baseline minus 3 Month Synovial Hypertrophy Scores.~This scale is called the Grey Scale Synovial Hypertrophy Score (GSUS). Please note that B-mode is the same as GSUS. It ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. Therefore, a higher value of the total score for GSUS represents more severe disease level."|Baseline, 3 Month||||units on a scale||Standard Deviation|Mean
2644545|NCT01717859|Secondary|Baseline to Month 6 Change in Total Power Doppler Synovitis Score of 34 Joints (Range 0 - 102)|"34 joints will be evaluated using a 0 to 3 point scale for each joint. Power Doppler synovitis score is the sum of all the joint scores. Change scores are calculated by subtracting Baseline minus 6 Month Power Doppler scores.~This scale is called the Power Doppler Synovitis Score (PDUS). It ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. Therefore, a higher value of the total score for PDUS represents more severe disease level."|Baseline, 6 Month||||units on a scale||Standard Deviation|Mean
2644546|NCT01717859|Primary|Baseline to Month 3 Change in Total Power Doppler Synovitis Score of 34 Joints (Range 0 - 102)|"34 joints will be evaluated using a 0 to 3 point scale for each joint. Power Doppler synovitis score is the sum of all the joint scores. Change scores are calculated by subtracting Baseline minus 3 Month Power Doppler scores.~This scale is called the Power Doppler Synovitis Score (PDUS). It ranges from 0 to 102. Scores of 0 indicate the least amount of inflammation of the joint while scores of 3 indicate the most amount of inflammation. Therefore, a higher value of the total score for PDUS represents more severe disease level."|Baseline, 3 Month||||units on a scale||Standard Deviation|Mean
2644547|NCT01717768|Other Pre-specified|AUC 0-24 Hrs After 120 mg Dose of TSX-002|AUC 0-24 hrs with PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3.|24 hrs|All subjects that received 120 mg TSX-002 under defined Treatment conditions (timing of high-calorie, high-fat meal).|||hr×ng/dL||Standard Deviation|Median
2644548|NCT01717768|Other Pre-specified|Cavg 0-24 Hrs (ng/dL) After 120 mg Dose|PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3. Mean of Cavg values from all time points for 14 subjects.|24 hrs|All subjects that received 120 mg TSX-002 under defined Treatment conditions (timing of high-calorie, high-fat meal).|||ng/dL||Standard Deviation|Least Squares Mean
2644549|NCT01717768|Secondary|Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax > 2500 ng/dL After 15 Days of BID Treatment|Cmax. PK samples taken at 0, 2, 4, 5, 6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 13, 14, 15, 16, 17,18, 20, 24 hours post-dose after 15 days of treatment for Part 4.|15 days|All efficacy analyses were conducted based on the modified intent-to-treat (MITT) analysis population, comprised of all randomized subjects who receive at least 1 dose of study drug and have at least 1 post-baseline measurement of total serum testosterone.|||percentage of subjects|||Number
2644550|NCT01717768|Primary|Percentage of Subjects Achieving a 24 Hour Average Total Serum Testosterone Concentration (Cavg,0-24h) in the Range of 300 to 1050 ng/dL After 15 Days of Treatment With TSX-002|Percentage of subjects achieving a 24-hour average total serum testosterone concentration (Cavg,0-24h) in the range of 300 to 1050 ng/dL after 15 days of treatment with TSX-002. PK samples taken at 0 ,2 ,4, 5 ,6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8 ,12, 13, 14, 15, 16, 17, 18, 20, 24 hours post-dose after 15 days of treatment for Part 4.|15 days|All efficacy analyses were conducted based on the modified intent-to-treat (MITT) analysis population, comprised of all randomized subjects who receive at least 1 dose of study drug and have at least 1 post-baseline measurement of total serum testosterone.|||percentage of participants|||Number
2644551|NCT01717742|Other Pre-specified|Chest Radiography|The radiograph closest to the time of drain removal will be reviewed by a blinded study radiologist to determine the percentage of hemithorax occupied using a 5 point ordinal scale utilized in previous studies ranging from no fluid present to fluid occupying >75% of the most affected hemithorax.|7 days after drain removal|Degree of opacification on chest radiography prior to chest tube removal|||Participants|||Count of Participants
2644552|NCT01717742|Secondary|Mortality|Mortality from any cause during the hospitalization for empyema.|up to 4 months||||Participants|||Count of Participants
2644553|NCT01717742|Secondary|Cost of the Hospitalization|An economic evaluation will compare the relative costs of DNase-tPA with tPA alone in previously well children who present with pleural empyema, using patient-level data from the trial.|up to 4 months||||2018 US $||Standard Deviation|Mean
2644554|NCT01717742|Secondary|Number of Participants With Hospital Readmission|Number of Participants who had any hospital readmission after discharge from hospital for initial treatment for pleural empyema within three months related to pleural empyema or its treatment.|3 months post-discharge||||Participants|||Count of Participants
2644555|NCT01717742|Secondary|Number of Participants With Further Interventions|Number of participants who needed further intervention such as placement of another chest drain (by any technique) or surgical intervention such as thoracotomy and decortication, video-assisted thorascopic surgery, or pneumonectomy.|up to 4 months||||Participants|||Count of Participants
2644560|NCT01717742|Secondary|Time to Meeting Discharge Criteria|"Time from insertion of the chest drain to meeting discharge criteria.~Discharge criteria:~Chest tube removed~No fever [temperature less than 38°C]~Normal respiratory rate forage~No hypoxia~Drinking fluids wel"|up to 4 months||||days||Standard Deviation|Mean
2644561|NCT01717742|Primary|Time to Hospital Discharge|Time from insertion of the chest drain to discharge from hospital.|up to 4 months||||days||Standard Deviation|Mean
2644562|NCT01717638|Secondary|Number of Subjects Reporting Unsolicited AEs After Any Vaccination.|The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.|From day 1 to study termination|Analysis was done on the safety population.|||Number of participants|||Number
2644563|NCT01717638|Secondary|Number of Subjects Reporting Unsolicited AEs After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)|The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with Unsolicited AEs, Serious Adverse Events (SAEs), AEs leading to premature withdrawal.|From day 1 to study termination|Analysis was done on the safety population.|||Number of subjects|||Number
2644564|NCT01717638|Secondary|Number of Subjects Reporting Unsolicited AEs After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)|The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with unsolicited AEs, Serious Adverse Events (SAE), AEs leading to premature withdrawal.|From day 1 to study termination|Analysis was done on the safety population.|||Number of subjects|||Number
2644565|NCT01717638|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age|The safety and tolerability of rMenB+OMV NZ vaccine in 4 year old children who received 2 catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months, is reported as number of subjects with solicited local* and systemic adverse events.|From day 1 to day 7 after any vaccination|Analysis was done on the safety population.|||Number of subjects|||Number
2644566|NCT01717638|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 3rd Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)|The safety and tolerability of the 3rd dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules is reported as number of subjects with solicited local and systemic adverse events.|From day 1 to day 7 after vaccination|Analysis was done on the safety population.|||Number of subjects|||Number
2644567|NCT01717638|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age)|The safety and tolerability of the 5th dose rMenB+OMV NZ vaccine in children (at 4 years of age) who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules in the earlier studies is reported as number of subjects with solicited local and systemic adverse events.|From day 1 to day 7 after vaccination|Analysis was done on the safety population, ie, all subjects in the Exposed population who provided post vaccination and post-baseline safety data.|||Number of subjects|||Number
2644568|NCT01717638|Secondary|Percentages of Subjects With 4-fold Increase in Serum Bactericidal Titers, Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age|The percentages of subjects with 4-fold increase in hSBA titers, one month following a two catch up dose of rMenB+OMV NZ at 4 years of age are reported.|Day 91 (1 month post second vaccination)|Analysis was done on FAS (Immunogenicity).|||Percentages of subjects||95% Confidence Interval|Number
2644569|NCT01717638|Secondary|GMRs of GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age|The GMR of GMTs(one month post dose 2/baseline) in children following a two catch up dose of rMenB+OMV NZ at 48 and 50 months of age are reported.|Day 91 (1 month post second vaccination)|Analysis was done on FAS (Immunogenicity).|||Ratio||95% Confidence Interval|Geometric Mean
2644570|NCT01717638|Secondary|GMTs Following 2 Catch up Doses of rMenB+OMV NZ Vaccine at 4 Years of Age|The GMTs in children who received two catch up doses of rMenB+OMV NZ vaccine at 48 and 50 months of age are reported.|Day 91 (1 month post second vaccination)|Analysis was done on FAS (Immunogenicity).|||Titers||95% Confidence Interval|Geometric Mean
2644571|NCT01717638|Secondary|Percentages of Subjects With hSBA ≥1:5 and ≥1:8 in Response of Two Catch up Doses of rMenB+OMV NZ Vaccine When Administered to Children at 4 Years of Age.|"The sufficiency of immune response is reported in terms of percentages of subjects with hSBA ≥1:5 and ≥1:8 in response of two catch up doses of rMenB+OMV NZ vaccine, administered two months apart, in children at 4 years of age.~Immune response was considered sufficient if the lower limit of the two-sided 95% CI for the percentage of subjects achieving hSBA ≥ 1:5 at one month after the two-dose series was ≥ 70% for all three indicator (H44/76; 5/99 and NZ 98/254) strains.~Immune sufficiency was not applicable for M10713 strain."|Day 91 (1 month post second vaccination)|Analysis was done on FAS (Immunogenicity).|||Percentages of subjects||95% Confidence Interval|Number
2644572|NCT01717638|Secondary|Percentages of Subjects With a 4-fold Increase in hSBA Titers Following a Third Dose of rMenB+OMV NZ Vaccine Given at 4 Years of Age to Children Who Previously Received 2 Catch up Doses of the Same Vaccine|"The percentage of subjects with a four-fold increase in hSBA titers following a third dose of rMenB+OMV NZ vaccine, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules,are reported.~Fourfold increase is defined as- for subjects with a pre-vaccination titer <1:2 to a post-vaccination titer ≥1:8 and for subjects with a pre-vaccination titer ≥1:2 to a post-vaccination titer ≥ 4 fold pre-vaccination titer."|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).|||Percentages of subjects||95% Confidence Interval|Number
2646162|NCT01705730|Secondary|Percentage of Participants Who Had DMARDs During Study||Month 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, number of participants analyzed signifies those participants who had addition of DMARDs during study.|||percentage of participants|||Number
2644573|NCT01717638|Secondary|GMRs of GMTs in Children Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules.|The GMRs of GMTs following a third dose of rMenB+OMV NZ vaccine (one month post 3rd dose/persistence at 48 months) in children, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of the same vaccine according to different schedules, are reported.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).|||Ratio||95% Confidence Interval|Geometric Mean
2644574|NCT01717638|Secondary|GMTs Following a Third Dose of rMenB+OMV NZ Vaccine in Children (at 4 Years of Age) Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules|The GMTs, one month following a third dose of rMenB+OMV NZ vaccine in 4 year old children who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).|||Titers||95% Confidence Interval|Geometric Mean
2644575|NCT01717638|Secondary|Percentages of Subjects With hSBA Titers ≥1:5 and ≥1:8 Following a Third Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 2 Catch up Doses of the Same Vaccine According to Different Schedules|The percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8 at one month after a third dose of rMenB+OMV NZ vaccine was given to children, who had previously received 2 catch up doses (at 12,14 or 18,20 or 24,26 months) of the same vaccine according to different schedules, are reported.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).|||Percentages of subjects||95% Confidence Interval|Number
2644576|NCT01717638|Secondary|Percentages of Subjects With Fourfold Increase in hSBA Titers After Receiving a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules|The fourfold increase in hSBA titers, one month after a 5th dose of rMenB+OMV NZ vaccine was given to children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in children who received the first dose of rMenB+OMV NZ vaccine at 4 years of age.|Day 31 (1 month post vaccination)|Analysis was done on FAS, Immunogenicity.|||Percentages of subjects||95% Confidence Interval|Number
2644577|NCT01717638|Secondary|Geometric Mean Ratios of GMTs in Subjects Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age), Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules|The GMRs of GMTs (one month post booster/48 months persistence), one month after a 5th dose of rMenB+OMV NZ vaccine was given children, who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the GMR (one month post 1 dose\baseline) of children who received first dose of rMenB+OMV NZ at 4 years of age.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).|||Ratio||95% Confidence Interval|Geometric Mean
2644578|NCT01717638|Secondary|GMTs in Children Following a Fifth Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules|The GMTs, at one month after a 5th dose of rMenB+OMV NZ vaccine in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules, are compared with the GMTs of children who received first dose of rMenB+OMV NZ at 4 years of age.|Day 31 (1 month post vaccination)|Analysis was done on FAS (Immunogenicity).|||Titers||95% Confidence Interval|Geometric Mean
2644579|NCT01717638|Secondary|Percentages of Subjects With Serum Bactericidal Titers ≥1:5 and ≥1:8 After a 5th Dose of rMenB+OMV NZ Vaccine (at 4 Years of Age) Who Had Previously Received 3 Primary Doses and a Booster Dose of the Same Vaccine According to Different Schedules|The Percentages of subjects with hSBA titers ≥1:5 and ≥1:8, one month after a 5th dose of rMenB+OMV NZ vaccine was given children who had previously received 3 primary doses (at 2, 3, 4,or 2, 4, 6 months) and a booster dose (at 12, 18 or 24 months) of the same vaccine according to different schedules is compared with the hSBA response of children who received first dose of rMenB+OMV NZ at 4 years of age.|Day 31 (1 month post vaccination)|Analysis was done on FAS, Immunogenicity, ie, all subjects in the enrolled population who actually received a study vaccination, and provided at least one evaluable serum sample at post baseline.|||Percentages of subjects||95% Confidence Interval|Number
2644580|NCT01717638|Secondary|GMRs of GMTs in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules|The GMRs of GMTs (48 months/one month post last vaccination) in children at 4 years of age who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules.|Day 1 (22-34 months post last MenB vaccine)|FAS, Persistency.|||Ratio||95% Confidence Interval|Geometric Mean
2644581|NCT01717638|Secondary|Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules|The persisting GMTs in children at 4 years of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) of rMenB+OMV NZ vaccine according to different schedules are reported.|Day 1 (22-36 months post last MenB vaccine; baseline for naive)|FAS, Persistency.|||Titers||95% Confidence Interval|Geometric Mean
2644582|NCT01717638|Secondary|Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Two Catch up Doses of rMenB+OMV NZ Vaccine According to Different Schedules|The antibody persistence in children at 4 year of age, who had previously received 2 catch up doses (at 12, 14 or 18, 20 or 24, 26 months) according to different schedules is reported as percentages of subjects with hSBA titers ≥1:5 and hSBA titers ≥1:8.|Day 1 (22-34 months post last MenB vaccine)|FAS, Persistency. Note: Reporting groups in this endpoint and in endpoints 5 and 6 received vaccination according to different schedules with respect to the groups reported in endpoints 1, 2 and 3.|||Percentages of subjects||95% Confidence Interval|Number
2644599|NCT01717521|Primary|Mean ANI Changes After Intubation|ANI stands for Analgesia Nociception Index. Its a dimension less number computed by a pain monitor ranging from 0-100. An index of 100 means absent pain, and the number decreases as pain increases. ANI was measured pre- and post- Intubation|Before vs after intubation|This pilot study included 20 women undergoing abdominal hysterectomies|||index||Standard Deviation|Mean
2644583|NCT01717638|Primary|Geometric Mean Ratios (GMRs) in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules|The GMRs of GMTs (48 months/one month post booster vaccination) at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is reported.|Day 1 (24-36 months post booster dose; baseline for naive)|FAS, Persistency.|||Ratio||95% Confidence Interval|Geometric Mean
2644584|NCT01717638|Primary|Persisting Antibody Titers in Children (at 4 Years of Age) Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules|The persisting antibody titers at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12, 18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the titers in naive children and reported as geometric mean titers (GMTs).|Day 1 (24-36 months post booster; baseline for naive)|FAS, Persistency.|||Titers||95% Confidence Interval|Geometric Mean
2644585|NCT01717638|Primary|Percentages of Subjects With Persisting Serum Bactericidal Titers ≥1:5 and ≥1:8 (at 4 Years of Age), Who Had Previously Received Three Primary Doses and One Booster Dose of rMenB+OMV NZ Vaccine According to Different Schedules|"The antibody persistence at 4 years of age in children who had previously received 3 primary doses (at 2, 3, 4, or 2, 4, 6 months) followed by a booster dose (at 12,18 or 24 months) of rMenB+OMV NZ vaccine according to different schedules is compared with the response in naïve children and reported as percentages of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and ≥1:8.~The functional bactericidal antibodies directed against serogroup B meningococci were assessed using the Serum Bactericidal Assay (SBA) using human serum as the source of exogenous complement (hSBA)."|Day 1 (24-36 months post booster; baseline for naive)|Full Analysis Set (Fas), Persistency: All subjects in the enrolled population who provided at least one evaluable serum sample at baseline (visit 1). Persistence data sets include nonvaccination and vaccination subsets of subjects from different groups with different primary vaccination schedules of MenB+Routine vaccines and routine vaccines.|||Percentages of subjects||95% Confidence Interval|Number
2644586|NCT01717521|Other Pre-specified|Average Ketamine Used|Amount of Ketamine used during surgery|Surgery||||mg||Standard Deviation|Mean
2644587|NCT01717521|Secondary|Mean MAP Changes After Skin Incision|MAP was measured pre- and post- skin incision.|Before vs after skin incision||||mmHg||Standard Deviation|Mean
2644588|NCT01717521|Secondary|Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus|MAP was measured pre- and post-ketamine administration|Before vs 3 min after Ketamine adminstration||||mmHg||Standard Deviation|Mean
2644589|NCT01717521|Secondary|Change in Mean Arterial Pressure After Intubation|MAP or mean arterial pressure is the average blood pressure of an individual and is measured non-invasively during surgery. MAP was measured pre- and post-intubation.|Before vs after intubation||||mmHg||Standard Deviation|Mean
2644590|NCT01717521|Secondary|Mean Heart Rate Change After Skin Incision|Heart rate was measured pre- and post-skin incision.|Before vs after skin incision||||bpm||Standard Deviation|Mean
2644591|NCT01717521|Secondary|Mean Heart Rate Change 3 Min After Ketamine Bolus|Heart rate was measured pre- and post- Ketamine administration|Before vs 3 min after Ketamine adminstration||||bpm||Standard Deviation|Mean
2644592|NCT01717521|Secondary|Mean Heart Rate Change After Intubation|Heart rate assessed by continuous pulse oximetry. Heart rate was measured pre- and post-intubation.|Before vs after intubation||||bpm||Standard Deviation|Mean
2644593|NCT01717521|Secondary|Mean BIS Changes After Skin Incision|"BIS was measured pre- and post-skin incision.~BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).~100-90: awake and responding appropriately to verbal stimulation~80-70: responsive to loud commands or mild shaking~60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall~<40: deep hypnotic state; possible protective responses still intact~<20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact~0: totally suppressed EEG (flat line)"|Before vs after skin incision||||score on a scale||Standard Deviation|Mean
2644594|NCT01717521|Secondary|Mean BIS Changes 3 Min After Ketamine Bolus|"BIS was measured pre- and post-Ketamine administration.~BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).~100-90: awake and responding appropriately to verbal stimulation~80-70: responsive to loud commands or mild shaking~60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall~<40: deep hypnotic state; possible protective responses still intact~<20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact~0: totally suppressed EEG (flat line)"|Before vs 3 min after Ketamine adminstration||||score on a scale||Standard Deviation|Mean
2644595|NCT01717521|Secondary|Mean BIS Changes After Intubation|"BIS was measured pre- and post-intubation.~BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).~100-90: awake and responding appropriately to verbal stimulation~80-70: responsive to loud commands or mild shaking~60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall~<40: deep hypnotic state; possible protective responses still intact~<20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact~0: totally suppressed EEG (flat line)"|Before vs after intubation||||score on a scale||Standard Deviation|Mean
2644596|NCT01717521|Primary|Mean ANI Changes After Skin Incision|ANI was measured pre- and post- skin incision|Before vs after skin incision||||index||Standard Deviation|Mean
2644597|NCT01717521|Primary|Mean ANI Changes 5 Min After Ketamine Bolus|ANI was measured pre- and post- i.v. ketamine administration|Before vs 5 min after Ketamine adminstration||||index||Standard Deviation|Mean
2644601|NCT01717482|Secondary|Measure Metformin Sensitivity in Induced Pluripotent Stem Cells (iPS)|To develop the metformin sensitivity index based on iPS cell line metformin sensitivity measurements from the first 20 patients randomized to the metformin arm. We will then To apply the metformin sensitivity index on the remaining 25 patients randomized to metformin and the 45 observation patients (70 patients total) to compare the 2-year RFS rate between metformin-sensitive and metformin-not-sensitive patients.|4 years|Study terminated due to poor accrual and funding ended||||||
2644602|NCT01717482|Primary|Number of Participants With 2-year Recurrence Free Survival|To compare the 2-year recurrence free survival (RFS) rate between metformin and observation.|4 years|Study terminated due to poor accrual and funding ended||||||
2644603|NCT01717482|Primary|Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction|To evaluate the feasibility of patient randomization, accrual, and tissue collection in a pilot study of metformin versus observation following resection of stage IA-IIIA lung squamous cell cancer for patients by assessing the reasons patients decline randomization, tracking accrual numbers, and tracking collected tissue and reasons why tissue was not collected.|2 years|Study terminated due to poor accrual and funding ended||||||
2644604|NCT01717456|Other Pre-specified|Caregiver's Ability and Willingness to Assist With ADLs at End of Treatment|"OASIS question M2100, item A: Types and sources of assistance for ADLs. Measure as moderator of treatment effectiveness. Responses range from No assistance needed in this area to Assistance needed, but no Caregivers available. Ordinal scale with 6 levels:~0= No assistance needed~Caregiver provides assistance~Caregiver needs training or support~Caregiver is unlikely to provide assistance~Unclear if caregiver will assist patient~Assistance is needed but is not available"|End of Treatment (Week 6)|Analysis population consists of all patients who provided data at end of treatment|||units on a scale||Full Range|Median
2644605|NCT01717456|Other Pre-specified|Patient's Living Situation at End of Treatment|OASIS question M1100: Patient living situation: This is a measure that combines who lives with the patient and the frequency that assistance is available to them throughout the day. Responses are coded on a 1-15 scale. Measure this as a moderator of treatment effectiveness.|End of Treatment (Week 6)|Analysis population consists of all patients who provided data at end of treatment|||participants|||Number
2644606|NCT01717456|Other Pre-specified|Depression Screening at End of Treatment|"OASIS question M1730: Depression Screening. Measure as a moderator of treatment effectiveness on categorical scale. Possible responses are:~0= No screening~Screened for depression with PHQ2 measure~Screened with PHQ2 and meets criteria for further evaluation of depression~Screened and does not meet criteria for further evaluation of depression"|End of Treatment (Week 6)|Analysis population consists of all patients providing data at end of treatment.|||participants|||Number
2644607|NCT01717456|Other Pre-specified|When is Patient Anxious at End of Treatment?|"OASIS question M1720: When anxious (reported or observed within the last 14 days). Measured as moderator of treatment effects on ordinal scale. Higher scores indicate a greater level of anxiousness. Responses are:~0 - None of the time~- Less often than daily~- Daily, but not constantly~- All of the time"|End of Treatment (Week 6)|Analysis population consists of all patients who provided end of treatment data.|||units on a scale||Full Range|Median
2644608|NCT01717456|Other Pre-specified|Ability to Reach Toilet at End of Treatment|"OASIS question M1840: Toilet transferring: Current ability to get to and from the toilet or bedside commode safely and transfer on and off toilet/commode. Measure as moderator of treatment outcomes.~A lower score is better.~Responses:~0. Able to get to and from the toilet and transfer independently with or without a device.~When reminded, assisted, or supervised by another person, able to get to and from the toilet.~Unable to get to and from the toilet but is able to use a bedside commode (with or without assistance).~Unable to get to and from the toilet or bedside commode but is able to use a bedpan/urinal independently.~Is totally dependent in toileting."|End of Treatment (Week 6)|All patients who provided data for this measure at the end of treatment.|||units on a scale||Full Range|Median
2644609|NCT01717456|Other Pre-specified|Change in Ambulation From Baseline to End of Treatment|"OASIS question M1860: Ambulation/locomotion: Current ability to walk safely, once in a standing position, or use a wheelchair, once in a seated position, on a variety of surfaces. Measure as a moderator of treatment effects. Responses:~0. Able to independently walk on even and uneven surfaces and negotiate stairs with or without railings (i.e., needs no human assistance or assistive device).~Requires use of a device (e.g., cane, walker) to walk alone or requires human supervision or assistance to negotiate stairs or steps or uneven surfaces.~Able to walk only with the supervision or assistance of another person at all times.~Chairfast, unable to ambulate but is able to wheel self independently.~Chairfast, unable to ambulate and is unable to wheel self.~Bedfast, unable to ambulate or be up in a chair.~Higher scores represent improvement in ability to ambulate."|Baseline, End of Treatment (Week 6)|Analysis sample consists of all patients who provided data for this questionnaire at the end of treatment. Two EMB subjects did not provide this data for unknown reasons, and 4 SC subjects did not provide this data for unknown reasons.|||units on a scale||Full Range|Median
2644610|NCT01717456|Other Pre-specified|Cognitive Status at End of Treatment|"OASIS question M1700: Cognitive functioning: Patient's current (day of assessment) level of alertness, orientation, comprehension, concentration, and immediate memory for simple commands. Measure as treatment moderator. Response categories are:~0 - Alert/oriented, able to focus and shift attention, comprehends and recalls task directions independently.~- Requires prompting (cuing, repetition, reminders) only under stressful or unfamiliar conditions.~- Requires assistance and some direction in specific situations (e.g., on all tasks involving shifting of attention), or consistently requires low stimulus environment due to distractibility.~- Requires considerable assistance in routine situations. Is not alert and oriented or is unable to shift attention and recall directions more than half the time.~- Totally dependent due to disturbances uch as constant disorientation, coma, persistent vegetative stte, or delirium."|End of Treatment (Week 6)|Analysis population is all patients who provided data on this measure at end of treatment. Data were missing for 2/11 in Group A and 6/8 in Group B.|||units on a scale||Full Range|Median
2644611|NCT01717456|Secondary|MHQ Sleep Energy at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
2644612|NCT01717456|Secondary|MHQ Sleep Energy at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
2644613|NCT01717456|Secondary|MHQ Emotions at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
2644614|NCT01717456|Secondary|MHQ Emotions at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
2644615|NCT01717456|Secondary|MHQ Personal Relationships at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
2644616|NCT01717456|Secondary|MHQ Personal Relationships at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
2644617|NCT01717456|Secondary|MHQ Social Limitations at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
2644618|NCT01717456|Secondary|MHQ Social Limitations at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
2644619|NCT01717456|Secondary|MHQ Physical Limitations at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
2644620|NCT01717456|Secondary|MHQ Physical Limitations at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
2644621|NCT01717456|Secondary|MHQ Role Limitations at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
2644622|NCT01717456|Secondary|MHQ Role Limitations at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
2644623|NCT01717456|Secondary|MHQ Incontinence Impact at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
2644624|NCT01717456|Secondary|MHQ Incontinence Impact at End of Treatment|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0-100, with higher scores signifying greater impairment in quality of life.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
2644625|NCT01717456|Secondary|Admission to Nursing Home at End of Treatment|Was patient admitted to a nursing home for one or more days at any time between enrollment and follow-up 7-8 months after treatment onset.|End of Treatment (Week 6)|Analysis sample was all patients who provided data at end of treatment.|||participants|||Number
2644626|NCT01717456|Secondary|Urinary Incontinence Status Change From Baseline to End of Treatment|"OASIS question M1610: Urinary incontinence or urinary catheter presence. Response options are:~0 - No incontinence or catheter (includes anuria or ostomy for urinary drainage)~- Patient is incontinent~- Patient requires a urinary catheter (i.e., external, indwelling, intermittent, suprapubic)"|Baseline, end of treatment (week 6)|Analysis population consists of all patients who provided end of treatment data. Data were missing for 2/11 in Group A and 6/8 in Group B.|||units on a scale||Full Range|Median
2644627|NCT01717456|Secondary|Fecal Incontinence Frequency at End of Treatment|"OASIS question M1620: Bowel incontinence frequency. Response options are:~0 - Very rarely or never has bowel incontinence~- Less than once weekly~- One to three times weekly~- Four to six times weekly~- On a daily basis~- More often than once daily"|End of Treatment (Week 6)|Analysis population consists of all patients who provided data at the end of treatment visit. Data is missing for 2/11 in Group A and 6/8 in Group B.|||units on a scale||Full Range|Median
2644628|NCT01717456|Secondary|Zarit Caregiver Burden Scale at Follow Up|Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The total score range is from 0 to 66. Higher scores indicate greater severity of burden on the family.|6 months after (6-Week) treatment ends|Family caregivers of patients completing the study. Some caregivers declined or no caregiver was available.|||units on a scale||Standard Deviation|Mean
2644629|NCT01717456|Secondary|Zarit Caregiver Burden Scale at End of Treatment|Validated questionnaire developed to assess the psychosocial and health burden experienced by a family caregiver of the identified patient. The 22-items ask about behaviors and feelings of caregivers on a 6-step ordinal scale (never to almost always). The scale is valid for caregivers of individuals with diverse chronic disabilities (dementia, advanced cancer, acquired brain injury). The scale has good internal consistency. Total scores range 0-66, and 21 or greater is interpreted as high burden (J Clin Epidemiol 2010;63:535-42). Subscales (role and personal strain) have been described but are unreliable so total scores were used.|End of Treatment (Week 6)|Family caregivers of patients completing the study. Some caregivers declined or no caregiver was available.|||units on a scale||Standard Deviation|Mean
2644630|NCT01717456|Secondary|MHQ Severity Scale at Follow Up|Quality of life scale specific to fecal incontinence. This is one of 8 subscales. This subscale has a range of 0 to 100. Higher scores indicate greater impact on quality of life.|6 months after (6-Week) treatment ends|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
2644631|NCT01717456|Secondary|MHQ Severity Scale at End of Treatment|Quality of life scale specific to fecal incontinence. Severity is one of 8 MHQ subscales. This subscale has a range of 0 to 100. Higher scores indicate greater severity of QOL impact.|End of Treatment (Week 6)|All subjects completing end of treatment home visit with research assistant.|||units on a scale||Standard Deviation|Mean
2644632|NCT01717456|Secondary|Adequate Relief of Fecal Incontinence at Follow Up|"At follow up 6 months after the end of treatment, the subject is asked, Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]. A responder to treatment is a subject who answers yes. When applied to group analysis, a treatment is regarded as effective if the responder rate is at least 10% greater in the active treatment arm compared to the control arm. This measure is not recorded at baseline because it is undefined until treatment has been provided."|6 months after (6-Week) treatment ends|Data not available for 3/7 Educational-Medical-Behavioral group subject and for 2/2 Standard Care subjects.|||participants|||Number
2644633|NCT01717456|Secondary|Adequate Relief of Fecal Incontinence at End of Treatment|"At the end of treatment, the subject is asked, Compared to before you started home health care, have you experienced adequate relief of your fecal incontinence symptoms? [Responses: yes or no]. A responder is anyone answering yes. A treatment would be judged successful if there was at least 10% more responders in the active compared to the control groups."|End of Treatment (Week 6)|Data not available for 1/11 Educational-Medical-Behavioral group subject and for 2/8 Standard Care subjects.|||participants|||Number
2644634|NCT01717456|Primary|Fecal Incontinence Severity Index (FISI) at Follow-Up (FU)|At follow up 6 months after the end of treatment, the subject reports the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range is 0-61. No data is available to interpret the scale as mild, moderate, or severe fecal incontinence.|6 months after (6-Week) treatment ends|The analysis sample consists of all patients who provided data at the 6 month FU visit.|||units on a scale||Standard Deviation|Mean
2644635|NCT01717456|Primary|Fecal Incontinence Severity Index (FISI) at End of Treatment|At the end of treatment, the FISI requires the patient to report the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range of scores is 0-61. Higher scores show more severe fecal incontinence.|End of Treatment (Week 6)|Analysis population includes all participants who provided end of treatment data to research assistants during a home visit. One subject from the EMB treatment did not provide data, and 1 subject from the SC group did not provide these data.|||units on a scale||Standard Deviation|Mean
2644636|NCT01717391|Secondary|Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.|Lymphocyte counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up|baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment|This group includes all tumor types treated in this clinical trial and provides an overall averages.|||Participants|||Count of Participants
2644637|NCT01717391|Secondary|Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)|Absolute neutrophil counts (ANCs) measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up|baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment|This group includes all tumor types treated in this clinical trial and provides an overall averages.|||Participants|||Count of Participants
2644638|NCT01717391|Secondary|Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.|Platelet cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up|baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment|This group includes all tumor types treated in this clinical trial and provides an overall averages.|||Participants|||Count of Participants
2644639|NCT01717391|Secondary|Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts|White blood cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured weekly during combined chemotherapy and radiation therapy treatment and then once at 30 day follow-up and at 1 year follow-up|baseline, weekly during radiation treatment for up to 5 weeks, 30 days and 1 year after treatment|This group includes all tumor types treated in this clinical trial and provides an overall averages.|||Participants|||Count of Participants
2644640|NCT01717391|Secondary|Chemotherapy Compliance|The number of participants who had chemotherapy withheld at least once for low blood counts.|At 24 months||||Participants|||Count of Participants
2646184|NCT01705587|Secondary|Increased Bone Density|Percent change in Bone Mineral Density (BMD) as assessed by dual x-ray absorptiometry (DXA) at the spine, contralateral hip, distal 1/3 radius, and femoral neck|at 6 and 12 months||||percentage change in BMD||Standard Error|Mean
2644641|NCT01717391|Primary|Percent Difference From Baseline IMRT Plan (%)|The difference in volume of bone marrow receiving radiation using a bone-marrow-sparing radiation plan compared to a standard radiation plan (IMRT), expressed as a percentage. Both plans are patient-specific. Bone-marrow is identified using the baseline FLT PET/CT obtained pre-imaging. Active bone marrow is considered to have an uptake value (SUV) of 2, 3, or 4. The standard IMRT plan was created using the criteria of the National Cancer Institute's Radiation Therapy Oncology Group study RTOG-0418. Radiation doses evaluated are 5 Gray, 10 Gray, 20 Gray, and 30 Gray. The change in dose to tumor is also provided. A negative value indicates that more bone marrow or tissue was spared using the bone-marrow sparing plan.|Baseline (pre-treatment)|All participants who received an FLT PET/CT during radiation simulation.|||Percent difference (%)||Standard Deviation|Mean
2644642|NCT01717326|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR24 was defined as HCV RNA <25 IU/ml at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|24 weeks after end of therapy (up to 42 weeks)|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.|||percentage of participants||95% Confidence Interval|Number
2644643|NCT01717326|Secondary|Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After the End of All Therapy (SVR4)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR4 was defined as HCV RNA <25 IU/ml at 4 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|4 weeks after end of therapy (up to 22 weeks)|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.|||percentage of participants||95% Confidence Interval|Number
2644644|NCT01717326|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 12|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.|Week 12|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point. The B1, C1, and C2 arms only received 8 weeks of treatment and were thus excluded from this analysis.|||percentage of participants||95% Confidence Interval|Number
2644645|NCT01717326|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 4|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 4|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.|||percentage of participants||95% Confidence Interval|Number
2644646|NCT01717326|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 2|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 2|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.|||percentage of participants||95% Confidence Interval|Number
2644647|NCT01717326|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at Week 12|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.|Week 12|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point. The B1, C1, and C2 arms only received 8 weeks of treatment and were thus excluded from this analysis.|||percentage of participants||95% Confidence Interval|Number
2644648|NCT01717326|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at Week 4|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 4|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.|||percentage of participants||95% Confidence Interval|Number
2644649|NCT01717326|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at Week 2|HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 2|The PP population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.|||percentage of participants||95% Confidence Interval|Number
2644650|NCT01717326|Secondary|Mean Time to First Achievement of Undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA)|Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Kaplan Meier summary statistics were used to characterize the time to first achievement of undetectable HCV RNA.|From first dose of study medication until first achievement of undetectable HCV RNA (up to 18 weeks of treatment)|FAS; all randomized participants who received ≥1 dose of study treatment.|||days||Standard Error|Mean
2644651|NCT01717326|Primary|Percentage of Participants Discontinuing Study Therapy Due to an AE During the Treatment Period and First 14 Follow-up Days|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.|From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)|APaT population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).|||percentage of participants||95% Confidence Interval|Number
2644652|NCT01717326|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.|From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)|All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).|||percentage of participants||95% Confidence Interval|Number
2644653|NCT01717326|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR12 was defined as HCV RNA <25 IU/ml at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|12 weeks after end of therapy (up to 30 weeks)|The Per-Protocol (PP) population; all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.|||percentage of participants||95% Confidence Interval|Number
2644654|NCT01717313|Post-Hoc|Change From Baseline in 2-hour PMG at Week 24 (Phase A, Per-Protocol Population)|"Blood glucose was measured 2 hours after a meal (2-hour PMG). 2-hour PMG is expressed as mg/dL. This change from baseline in 2-hour PMG reflects the Week 24 2-hour PMG minus the Week 0 2-hour PMG.~A post-hoc sensitivity analysis was performed that excluded participants in both treatment groups who were found to have used prohibited metformin (see results above for a description of the use of prohibited metformin)."|Baseline and Week 24|The Per Protocol population excluded participants from the FAS population who either had <75% drug compliance or used a prohibited medication (including metformin).|||mg/dL||95% Confidence Interval|Least Squares Mean
2644655|NCT01717313|Post-Hoc|Change From Baseline in FPG at Week 24 (Phase A, Per-Protocol Population)|"Blood glucose was measured on a fasting basis (collected after an 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.~A post-hoc sensitivity analysis was performed that excluded participants in both treatment groups who were found to have used prohibited metformin (see results above for a description of the use of prohibited metformin)."|Baseline and Week 24|The Per-Protocol population excluded participants from the FAS population who either had <75% drug compliance or used a prohibited medication (including metformin).|||mg/dL||95% Confidence Interval|Least Squares Mean
2644656|NCT01717313|Post-Hoc|Change From Baseline in A1C at Week 24 (Phase A, Per-Protocol Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.~A post-hoc sensitivity analysis was performed that excluded participants in both treatment groups who were found to have used prohibited metformin (see results above for a description of the use of prohibited metformin)."|Baseline and Week 24|The Per-Protocol population excluded participants from the FAS population who either had <75% drug compliance or used a prohibited medication (including metformin).|||Percent||95% Confidence Interval|Least Squares Mean
2644657|NCT01717313|Secondary|Change From Baseline in FPG at Week 54 (Phase A + Phase B, FAS Population)|"Blood glucose was measured on a fasting basis (collected after an 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 54 minus the FPG level at Week 0.~The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Baseline and Week 54|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
2644658|NCT01717313|Secondary|Percentage of Participants Who Achieve an A1C Goal of <6.5% at Week 54 (Phase A + Phase B, FAS Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS population at Week 54.~The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Week 54|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques.|||Percentage of participants||95% Confidence Interval|Number
2644659|NCT01717313|Secondary|Percentage of Participants Who Achieve an A1C Goal of <7% (53 mmol/Mol) at Week 54 (Phase A + Phase B, FAS Population)|"The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS population at Week 54.~The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Week 54|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques.|||Percentage of participants||95% Confidence Interval|Number
2644660|NCT01717313|Secondary|Change From Baseline in A1C at Week 54 (Phase A + Phase B, FAS Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.~The results of the study at Week 54 may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Baseline and Week 54|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.|||Percent||95% Confidence Interval|Least Squares Mean
2644661|NCT01717313|Secondary|Change From Baseline in 2-hour Post Meal Glucose (PMG) at Week 24 (Phase A, FAS Population)|"Blood glucose was measured 2 hours after a meal (2-hour PMG). 2-hour PMG is expressed as mg/dL. This change from baseline in 2-hour PMG reflects the Week 24 2-hour PMG minus the Week 0 2-hour PMG.~Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Baseline and Week 24|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
2644662|NCT01717313|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Phase A, FAS Population)|"Blood glucose was measured on a fasting basis (collected after an 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.~Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Baseline and Week 24|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.|||mg/dL||95% Confidence Interval|Least Squares Mean
2644663|NCT01717313|Secondary|Percentage of Participants Who Achieve an A1C Goal of <6.5% (48 mmol/Mol) at Week 24 (Phase A, FAS Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS population at Week 24.~Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Week 24|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques.|||Percentage of participants||95% Confidence Interval|Number
2644673|NCT01717287|Primary|Percentage of Participants Who Discontinued Study Treatment Due to a Laboratory Adverse Experience|A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.|Up to Week 24|All patients as treated population included all enrolled participants who received at least one dose of study drug|||Percentage of participants|||Number
2644693|NCT01717040|Primary|Change in Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score|Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) is designed to assess the severity of depressive symptoms. Total scores can range from 0 to 84 with higher scores indicating a higher severity of depressive symptoms|Baseline and Week 8||||units on a scale||Standard Error|Least Squares Mean
2644664|NCT01717313|Secondary|Percentage of Participants Who Achieve an A1C Goal of <7% (53 mmol/Mol) at Week 24 (Phase A, FAS Population)|"A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS population at Week 24.~Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Week 24|The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques.|||Percentage of participants||95% Confidence Interval|Number
2644665|NCT01717313|Primary|Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population)|"An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.~This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Up to 57 weeks|The APaT population included all participants who received at least one dose of study drug.|||Percentage of participants|||Number
2644666|NCT01717313|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population)|"An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.~This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Up to 57 weeks|The APaT population included all participants who received at least one dose of study drug.|||Percentage of participants|||Number
2644667|NCT01717313|Primary|Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population)|"An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.~This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Up to 24 weeks|The APaT population included all participants who received at least one dose of study drug.|||Percentage of participants|||Number
2644668|NCT01717313|Primary|Percentage of Participants Who Experienced at Least One Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population)|"An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.~This analysis may have been confounded by use of prohibited metformin (see results above for description of the use of prohibited metformin)."|Up to 27 weeks|The All-Participants-as-Treated (APaT) population included all participants who received at least one dose of study drug.|||Percentage of participants|||Number
2644669|NCT01717313|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (Phase A, FAS Population)|"A1C (%) is used to report average blood glucose levels over prolonged periods of time.~Because it was discovered that in another omarigliptin study (MK-3102-028, NCT01814748) subjects had taken metformin (prohibited per protocol, and taken without investigator knowledge), after unblinding of Phase A of this study, an analysis of metformin levels was performed on stored Week 18 blood samples. Of the subjects not rescued with metformin prior to Week 18, 10% in the omarigliptin group and 20% in the placebo group had levels showing that they were taking metformin (prohibited per protocol). The use of prohibited metformin disproportionately by the placebo group may have resulted in a smaller than expected treatment effect for efficacy outcome measures (see post-hoc analysis)."|Baseline and Week 24|The Full Analysis Set (FAS) population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment.|||Percent||95% Confidence Interval|Least Squares Mean
2644670|NCT01717287|Secondary|Percentage of Participants Achieving HIV RNA <200 Copies/mL|This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL|Week 24|Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation, and had at least one postbaseline evaluation|||Percentage of participants||95% Confidence Interval|Number
2644671|NCT01717287|Secondary|Percentage of Participants Achieving HIV RNA <40 Copies/mL|This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL|Week 24|Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation, and had at least one postbaseline evaluation|||Percentage of participants||95% Confidence Interval|Number
2644672|NCT01717287|Secondary|Percentage of Participants Achieving >=1 log10 Reduction From Baseline in Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) or Had an HIV RNA Assessment of <200 Copies/mL|This outcome is a measure of virological (anti-retroviral) response to treatment. Plasma HIV RNA was measured using the Abbott RealTime HIV-1 assay, which has a linear range of 40 HIV RNA copies/mL to 10 million HIV RNA copies/mL|Week 24|Full analysis set included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had at least one postbaseline evaluation|||Percentage of participants||95% Confidence Interval|Number
2644674|NCT01717287|Primary|Percentage of Participants With at Least One Laboratory Adverse Experience|A laboratory adverse experience is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.|Up to Week 26|All patients as treated population included all enrolled participants who received at least one dose of study drug|||Percentage of participants|||Number
2644675|NCT01717287|Secondary|Change From Baseline in CD4 Cell Percentage|This outcome is a measure of immunological response to treatment|Baseline and Week 24|The population analyzed included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had Week 24 evaluation|||Percentage change||95% Confidence Interval|Mean
2644676|NCT01717287|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count|This outcome is a measure of immunological response to treatment|Baseline and Week 24|The population analyzed included all participants who received at least one dose of study drug, had baseline evaluation (required for change from baseline endpoints only), and had Week 24 evaluation|||cells/mm^3||95% Confidence Interval|Mean
2644677|NCT01717287|Primary|Percentage of Participants Who Discontinued Study Treatment Due to a Clinical Adverse Experience|A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.|Up to Week 24|All patients as treated population included all enrolled participants who received at least one dose of study drug|||Percentage of participants|||Number
2644678|NCT01717287|Primary|Percentage of Participants With at Least One Clinical Adverse Experience|A clinical adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience.|Up to Week 26|All patients as treated population included all enrolled participants who received at least one dose of study drug|||Percentage of participants|||Number
2644679|NCT01717209|Secondary|Heart Rate|Heart Rate was measured as mean of Heart Rate for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for heart rate is generally 60 to 100 beats per minutes in adults, but this can vary.|8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))||||beats/minute||Full Range|Mean
2644680|NCT01717209|Secondary|Mean Arterial Pressure (MAP)|Mean Arterial Pressure (MAP) was measured as mean of MAP for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for MAP is 70-110 mmHg.|8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))||||mmHg||Full Range|Mean
2644681|NCT01717209|Secondary|Central Venous Pressure (CVP)|Central Venous Pressure (CVP) was measured as mean of CVP for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for CVP is 3-8 mmHg.|8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))||||mmHg||Full Range|Mean
2644682|NCT01717209|Secondary|Systemic Vascular Resistance (SVR)|Systemic Vascular Resistance (SVR) was measured as mean of Systemic Vascular Resistance (SVR) for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for SVR is 800-1200 dynes/sec/cm5.|8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))||||dynes/sec/cm^5||Full Range|Mean
2644683|NCT01717209|Secondary|Right Heart Dysfunction|Right Heart Dysfunction was measured as mean of Right Ventricular Stroke Work Index (RVSWI) for the initial 8 hours after admission to the Intensive Care Unit (ICU). RVSWI is measured as the difference in mean pulmonary artery pressure (MPAP) and central venous pressure (CVP), divided by the cardiac index (CI): [(MPAP-CVP) / CI]. Normal range for RVSWI is 5-10 g/m.|8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))||||g/m||Full Range|Mean
2644684|NCT01717209|Primary|Pulmonary Hypertension|Pulmonary hypertension was measured as mean of Mean Pulmonary Artery Pressure for initial 8 hours after admission to the Intensive Care Unit (ICU). MPAP value ≥25 mmHg (resting) indicates pulmonary hypertension state.|8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))||||mmHg||Full Range|Mean
2644685|NCT01717053|Secondary|Safety and Tolerability|The number of patients experiencing an adverse event of at least grade 3 that is possibly, probably, or definitely related to study therapy per CTCAE version 4.0.|6 months|This analysis includes all patients that completed protocol therapy.|||participants|||Number
2644686|NCT01717053|Secondary|PSA < 1.5ng/ml in Setting of Non-castrate Testosterone|Proportion of men with 1, 2, 3, 4 and 5 year PSA < 1.5ng/ml in setting of non-castrate testosterone|1 year, 2 years, 3 years, 4 years, 5 years|||||||
2644687|NCT01717053|Secondary|Testosterone Recovery|Time to testosterone recovery|up to 5 years|||||||
2644688|NCT01717053|Secondary|Metastasis or Systemic Therapy|Time to metastasis or systemic therapy|up to 5 years|||||||
2644689|NCT01717053|Secondary|Biochemical Progression-free Survival|Disease progression defined as Phoenix RTOG definition of nadir + 2ng/ml or initiation of salvage therapy|up to 5 years|||||||
2644690|NCT01717053|Secondary|PSA Nadir Value|The lowest PSA value from the start of study therapy.|1 year, 2 years|This analysis includes all patients that completed protocol therapy.|||ng/mL||Full Range|Median
2644691|NCT01717053|Secondary|Time to PSA Nadir|The median time in months to the lowest PSA value from the start of study therapy.|1 year|This analysis includes all patients that completed protocol therapy.|||months||Full Range|Median
2644692|NCT01717053|Primary|Percentage of Patients With Undetectable PSA at 1 Year|The percentage of patients with undetectable PSA after 1 year will be calculated. Undetectable PSA is defined as a measurement of <0.1 ng/mL.|1 year|This analysis includes all patients that completed protocol therapy.|||percentage of participants|||Number
2644699|NCT01716754|Secondary|Change From Baseline in Mean Number of Puffs of Morning, Evening and Total Daily Asthma Rescue Medication|Participants recorded their use of rescue medication into an electronic diary (eDiary). A negative change from baseline indicates improvement.|Baseline, Week 16|The full analysis set (FAS) for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Only participants who had both baseline and week 16 values were analyzed. The FAS included randomized participants who received at least one dose of study drug.|||Number of puffs||Standard Error|Least Squares Mean
2644700|NCT01716754|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Score|The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to participants with asthma. The 32 items in the AQLQ were divided into four domain-specific scores and a total score as follows: Activity limitations = Mean of Items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32 (11 items); Symptoms = Mean of Items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30 (12 items); Emotional function = Mean of Items 7, 13, 15, 21, 27 (5 items); Environmental stimuli = Mean of Items 9, 17, 23, 26 (4 items); and Overall Score = Mean of Items 1 to 32 (32 items). Each item of the AQLQ was equally weighted and scored along a 7-point scale, where 1 indicates maximal impairment and 7 indicates no impairment. Thus, higher scores indicate better asthma-related quality of life. The mean overall score ranged from 1 to 7. A positive change from baseline indicates improvement.|Baseline, Week 16, Week 28|The FAS for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Participants who had values at both baseline and the post baseline time point were analyzed for that post baseline time point. The FAS included randomized participants who received at least one dose of study drug.|||Score on a scale||Standard Deviation|Mean
2644701|NCT01716754|Secondary|Percentage of Participants With a Change From Baseline in ACQ-7 Score Less Than -1.1|The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.|Week 16|The full analysis set (FAS) for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Only participants who had week 16 values were analyzed. The FAS included randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
2644702|NCT01716754|Secondary|Change From Baseline in ACQ-7 Score|The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7. A negative change from baseline indicates improvement.|Baseline, Weeks 4, 8, 12, 16 and 28|The FAS for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Participants who had values at both baseline and the post baseline time point were analyzed for that post baseline time point. The FAS included randomized participants who received at least one dose of study drug.|||Score on a scale||Standard Deviation|Mean
2644703|NCT01716754|Primary|Percentage of QGE031 Participants With Clinically Important Improvement of <= -0.5 in the Asthma Control Questionnaire 7 (ACQ-7) Score Compared to Placebo|The ACQ-7 measures asthma symptom control and consisted of 7 items: 5 on symptom assessment, 1 on rescue bronchodilator use and 1 on airway caliber (FEV1 % predicted). All 7 questions of the ACQ were equally weighted. Items 1-6 scored along a 7-point response scale, where 0 = good controlled and 6 = poor controlled. The 7th item on % predicted FEV1 (pre-bronchodilator) was scored by clinic staff on a 7-point scale (0 - > 95%; 1 - 90-95%; 2 - 80-89%; 3 - 70-79%; 4 - 60-69%; 5 - 50-59%; 6 - < 50%). The average score of the 7 questions was calculated as the sum of scores divided by the number of questions that were answered by the participants, as long as there were at least 6 questions answered and the missing items were neither question 1 nor question 7.|Week 16|The full analysis set (FAS) for the QGE031 240 mg q2w, placebo to QGE031 240 mg q2w and Omalizumab groups (n=120,49,131) was considered for the analysis. Only participants who had week 16 values were analyzed. The FAS included randomized participants who received at least one dose of study drug.|||Percentage of participants|||Number
2644704|NCT01716715|Other Pre-specified|c-MET Copy Number||Baseline|||||||
2644705|NCT01716715|Other Pre-specified|c-Met Expression||Baseline|||||||
2644706|NCT01716715|Secondary|To Estimate the Response Duration Among Patients Who Respond.|"The time participant is in response.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.,"|From the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented or date of death from any cause, whichever came first, assessed up to 18 months.|Patients who respond.|||months||Full Range|Median
2644707|NCT01716715|Secondary|Overall Survival|The time from randomization until death or date of last contact. Endpoint is death. Patients who are not observed with an endpoint are censored.|The duration of time from study entry to time of death or the date of last contact, an average of 2.5 years.|All enrolled participants|||months||90% Confidence Interval|Median
2644722|NCT01716585|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug.|||percentage of participants|||Number
2644708|NCT01716715|Secondary|Percentage of Participants With CA125 Response.|"Complete and Partial Tumor Response by CA125. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.,"|Prior to each cycle of treatment. Then follow-up every 3 months for 2 years then then every 6 months, up to 2.5 years.|Participants evaluable by CA125|||percentage of participants||90% Confidence Interval|Number
2644709|NCT01716715|Secondary|Response, Assessed According to RECIST Version 1.1|Complete and Partial Tumor Response by RECIST. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|CT or MRI used to follow lesion every 8 weeks for the first 8 months, then every 12 weeks until disease progression, approximately 2.5 years|All enrolled participants|||percentage of participants||90% Confidence Interval|Number
2644710|NCT01716715|Secondary|Number of Participants With Grade 3 or Higher Adverse Events by Type|Toxicities will be characterized by their frequency and severity, grade 3 and above.|Up to 30 days after completion of study treatment|Eligible and Treated participants|||Participants|||Count of Participants
2644711|NCT01716715|Primary|Event Free Survival|"Time from patient entry until progression, death, or beginning a subsequent therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.,"|The duration of time from study entry to time to progression or death,or begining a subsequent therapy, whichever occurs first, assessed up to 32 weeks|Enrolled Patients|||months||95% Confidence Interval|Median
2644712|NCT01716663|Secondary|Total Radiofrequency (RF) Time|Total RF time is defined as the total time RF is delivered during the procedure.|Day 0|Patients with non-missing RF application time.|||minutes||Standard Deviation|Mean
2644713|NCT01716663|Secondary|Mean Number of Radiofrequency (RF) Applications|RF application is defined as the number of times RF energy is delivered during the procedure.|Day 0|Patients with non-missing RF application values|||number of applications||Standard Deviation|Mean
2644714|NCT01716663|Secondary|Acute Procedural Success|Acute success will be defined as confirmation of pulmonary vein isolation by entrance block, exit block, and/or periostial block of all targeted pulmonary veins.|Day 0|Acute effectiveness and efficiency cohort|||participants|||Number
2644715|NCT01716663|Secondary|Total Procedure Time|The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.|Day 0|The number of patients with non-missing procedure time data.|||minutes||Standard Deviation|Mean
2644716|NCT01716663|Primary|Total Fluoroscopy Time|The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.|Day 0|Those patients with non-missing fluoroscopy time.|||minutes||Standard Deviation|Mean
2644717|NCT01716585|Secondary|Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.|Within 12 weeks post-treatment|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.|||percentage of participants||95% Confidence Interval|Number
2644718|NCT01716585|Secondary|Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm|Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.|||percentage of participants||95% Confidence Interval|Number
2644719|NCT01716585|Secondary|Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1b who received at least 1 dose of blinded study drug.|||percentage of participants|||Number
2644720|NCT01716585|Secondary|Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1a who received at least 1 dose of blinded study drug.|||percentage of participants|||Number
2644721|NCT01716585|Secondary|Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period|Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.|At 12 weeks|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug and had ALT ≥ ULN of the reference range at baseline were included in the analysis.|||percentage of participants|||Number
2646340|NCT01704495|Primary|Rate of Severe Asthma Exacerbations During 6 Months||From start of treatment up to 6 months|Full analysis set|||Exacerbations per 6 month||90% Confidence Interval|Least Squares Mean
2644723|NCT01716559|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.|Up to Week 16|The analysis was performed on total population.|||participants|||Number
2644724|NCT01716559|Secondary|Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy|"Effect of individual iron supplementation on the efficacy of Epoetin beta treatment was described by percentage of participants with or with no response on efficacy of treatment due iron replacement therapy. Response was determined by calculating the difference in Hb level at H3 (Week 8) as compared to H1 (baseline). If H3-H1 is greater than (>) 1, there is a response (response value =1), otherwise there was no response (response value=0). If both were missing, then response was also missing. Response value as 1 denotes an effect on the response of treatment with or without iron replacement therapy. Response value as 0 denotes no effect on the response of treatment with or without iron replacement therapy."|Up to Week 16|The analysis was performed on total population. At the end of the study, data allowing the evaluation of effect of individual iron supplementation on the efficacy of Epoetin beta treatment were available for 103 participants out of total population of 160.|||participants|||Number
2644725|NCT01716559|Secondary|Percentage of Red Blood Cell Transfusion-free Participants|Percentage of participants who have not received red blood cell (RBC) transfusion (packed RBC or whole blood) during the study were reported.|Up to Week 16|The analysis was performed on Total population.|||percentage of participants||95% Confidence Interval|Number
2644726|NCT01716559|Secondary|Mean Change From Baseline in Hemoglobin Level up to Week 16|The mean change in Hb concentration was calculated by subtracting the baseline Hb concentration from the Weekly Hb concentration.|Baseline, Week 4, Week 8, Week 12, and Week 16|"The analysis was performed on Total population. The n signifies the number of participants assessed for mean change in hemoglobin level for specified time point."|||g/dL||Standard Error|Mean
2644727|NCT01716559|Primary|Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8|Therapeutic response was defined as an increase of greater than or equal to (>=) 1 gram per decilitre (g/dL) in hemoglobin (Hb) level as compared to baseline, following 8 weeks of Epoetin beta treatment. The Therapeutic response rate was summarized as percentage of participants with an increase of >= 1 g/dL in Hb level at Week 8 as compared to baseline.|Baseline to Week 8|The analysis was performed on total population. At the end of the Week 8, data allowing the evaluation of the therapeutic response was available for 103 participants out of total population of 160.|||percentage of participants||95% Confidence Interval|Number
2644728|NCT01716533|Secondary|Number of Subjects With Risk Factors Associated With the CDI Recurrence|Risk factors for CDI included factors in three main domains involving host factors (advanced age, impaired immune status, co-morbidities); increased exposure to C. difficile spores (longer length of stays, healthcare environment, infected roommates or hand carriage by personnel); and factors that disrupt the normally protective colonic microflora layer (antimicrobials, other medications or procedures).|At recurrence (within 10 days of start diarrhea) during a follow up period of up to 72 days per participant|The analysis was performed on the Total enrolled cohort, which included all subjects enrolled in the study who recurred.|||Participants|||Count of Participants
2644729|NCT01716533|Secondary|Number of Subjects With Risk Factors Associated With the Initial CDI Episode|"Risk factors for CDI included factors in three main domains involving host factors (advanced age, impaired immune status, co-morbidities); increased exposure to C. difficile spores (longer length of stays, healthcare environment, infected roommates or hand carriage by personnel); and factors that disrupt the normally protective colonic microflora layer (antimicrobials, other medications or procedures).~CDI episodes within 6 months: Protocol exclusion criteria for enrolment allowed up to maximum 25% of the planned subjects having a previous CDI episode within the previous 6 months.~Antibiotic taken within 3 months: Antibiotic not prescribed to treat C. difficile taken within 3 months before the current CDI episode."|At Day 0|The analysis was performed on the Total enrolled cohort, which included all subjects enrolled in the study.|||Participants|||Count of Participants
2644730|NCT01716533|Secondary|Number of Subjects With Failure of Antibiotic Treatment|"Failure of antibiotic treatment against C. difficile is defined as the persistence or the incomplete resolution of symptoms (more than one unformed stool per day) after a full course of antibiotic(s) therapy (minimum 7 days).~Aminopen+BetaLactam Inhib,1st Gen.Cephalosporin = Aminopenicillin+Beta-Lactamase Inhibitor and 1st Generation Cephalosporin.~Aminopen+BetaLactam Inhib, 3rd Gen.Cephalosporin = Aminopenicillin+Beta-Lactamase Inhibitor and 3rd Generation Cephalosporin excluding Ceftazidime and Fluoroquinolone.~Aminopen+BetaLactam Inhib and Fluoroquinolone = Aminopenicillin+Beta-Lactamase Inhibitor and Fluoroquinolone.~Antipseudom Pen+BetaLactam Inhib and Cephalosporin = Antipseudomonal Penicillin+Beta-Lactamase Inhibitor and 1st Generation Cephalosporin and 3rd Generation Cephalosporin excluding Ceftazidime and Fluoroquinolone and Glycopeptides (Iv).~Antipseudom Pen+BetaLactam Inhib and Glycopeptides = Antipseudomonal Penicillin+Beta-Lactamase Inhibitor and Glycopeptides (Iv)."|Within 3 months before the initial CDI episodes|The analysis was performed on the Total enrolled cohort, which included all evaluable subjects for whom results about failure of antibiotic treatment (not prescribed to treat Clostridium difficile) were available within 3 months before the initial CDI episodes.|||Participants|||Count of Participants
2644731|NCT01716533|Secondary|Number of Subjects With CDI Recurrence by Severity, in Those Subjects Who Recur|A CDI recurrence is defined as the development of a new episode of CDI following clinical response at the end of standard of care (SoC) for the initial CDI episode. An episode of diarrhea was not considered as a recurrence of CDI if the stool was negative for C. difficile or if the diarrhea was attributed to another cause than C. difficile. The severity criteria for CDI recurrent episodes were categorized into non-severe and severe.|At recurrence (within 10 days of start diarrhea) during a follow up period of up to 72 days per participant|The analysis was performed on the Total enrolled cohort, which included all subjects enrolled in the study who recurred.|||Participants|||Count of Participants
2644732|NCT01716533|Secondary|Number of Subjects With Initial CDI Episode by Severity, in All Subjects|Initial CDI episodes were recorded by severity criteria: medical attention given, admission to intensive care unit, colectomy, death, high white blood cells (WBC) count, high creatinine count, hypotension/shock, clinical response to Standard of Care (SoC).|At Day 0|The analysis was performed on the Total enrolled cohort, which included all subjects enrolled in the study.|||Participants|||Count of Participants
2644733|NCT01716533|Secondary|CDI Initial Episodes Severity Characteristics, in All Subjects|Severity characteristics were expressed in duration of days for hospitalization, intensive care unit, Standard of Care (SoC) and CDI episodes.|At Day 0|The analysis was performed on the Total enrolled cohort, which included all subjects enrolled in the study and who reported any of the characteristics assessed.|||Days||Inter-Quartile Range|Median
2644734|NCT01716533|Secondary|Number of Subjects With Clostridium Difficile Infection (CDI) Recurrence|A CDI recurrence is defined as the development of a new episode of CDI following clinical response at the end of standard of care (SoC) for the initial CDI episode.|From Day 0 to Day 72|The analysis was performed on the Total enrolled cohort, which included all subjects enrolled in the study.|||Participants|||Count of Participants
2644735|NCT01716533|Secondary|Serum Neutralizing Anti-toxin A and Anti-toxin B Antibody Titers at Day 0, Within 10 Days After Recurrence and at Day 72|Neutralizing antibody concentrations were expressed as Geometric Mean Titers (GMTs), as measured in an inhibition of cytotoxicity assay (toxin neutralization assays) for the cut-off of 2, expressed in 1/DIL unit, in which DIL is the sample dilution corresponding to 50% neutralization. This measure concerned only diarrhea recurrence. No CDI recurrence was considered as part of the Group Sustained Response.|At Day 0, within 10 days after start of recurrent episode if any, and at end of follow-up (Day 72)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom the result for the considered assay was available for the blood sample taken at the considered time point.|||Titer||95% Confidence Interval|Geometric Mean
2644736|NCT01716533|Secondary|Serum Neutralizing Anti-toxin A and Anti-toxin B Antibody Titers at Day 14|Neutralizing antibody concentrations were expressed as Geometric Mean Titers (GMTs), as measured in an inhibition of cytotoxicity assay (toxin neutralization assays) for the cut-off of 2, expressed in 1/DIL unit, in which DIL is the sample dilution corresponding to 50% neutralization.|At Day 14|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom the result of at least one assay was available for the blood sample taken at Day 14.|||Titer||95% Confidence Interval|Geometric Mean
2644737|NCT01716533|Secondary|Serum Anti-toxin A and Anti-toxin B Antibody Concentrations at Day 0 and Day 72|Serum anti-toxin B antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), as measured by ELISA for the cut-off equal to or above (≥) 100 EU/mL.|At Day 0 and at Day 72|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom the result of at least one assay was available for the blood sample taken at Day 72. The development of the serum anti-toxin A ELISA was cancelled, therefore this analysis was not performed.|||EU/mL||95% Confidence Interval|Geometric Mean
2644738|NCT01716533|Primary|Serum F2 C-terminal Anti-toxin B Antibody Concentrations|Serum F2 C-terminal anti-toxin B antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), as measured by ELISA for the cut-off of 13.16 EU/mL.|At Day 14|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom the result of the considered assay was available for the blood sample taken at Day 14.|||EU/mL||95% Confidence Interval|Geometric Mean
2644739|NCT01716533|Primary|Serum Anti-toxin A and Anti-toxin B Antibody Concentrations at Day 14|Serum anti-toxin B antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), as measured by the Enzyme Linked Immunosorbent Assay (ELISA) for the cut-off of equal to or above (≥) 100 EU/mL.|At Day 14|The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom the result of the considered assay was available for the blood sample taken at Day 14. The development of the serum anti-toxin A ELISA was cancelled, therefore this analysis was not performed.|||EU/mL||95% Confidence Interval|Geometric Mean
2644740|NCT01716520|Secondary|Change From Baseline in Trough FEV1 on Day 15 of Each Treatment Period|Trough FEV1 on Treatment Day 15 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 14. Analysis was performed using an ANCOVA model with covariates of treatment, period, mean Baseline (BL), period BL, response type, and treatment by response type interaction. A participant is a reponder to UMEC if they were a responder to UMEC monotherapy or a responder to both UMEC monotherapy and VI monotherapy. A participant is a responder to VI if they were a responder to VI monotherapy or a responder to both UMEC monotherapy or VI monotherapy. BL is the mean FEV1 recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean BL is the mean of the BLs for each participant, and period BL is the difference between BL and the mean BL in each treatment period for each participant. Change from BL for each treatment period is the Day 15 value minus the BL value for that treatment period.|Baseline and Day 15 of each treatment period (up to study day 84)|ITT Population. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed for different parameters; the overall number of participants analyzed reflects everyone in the ITT Population.|||Liters||Standard Error|Least Squares Mean
2644741|NCT01716520|Secondary|Number of Participants With a Larger Change From Baseline in 0-6 Hour Weighted Mean FEV1 at Day 14 of Each Treatment Period With UMEC/VI Compared With UMEC and VI Alone|The number of participants with a larger change from Baseline in weighted mean FEV1 with UMEC/VI compared with UMEC and VI alone was recorded. Participants who improved on UMEC/VI had a larger change from Baseline difference in 0-6 hour weighted mean FEV1 on Day 14 on UMEC/VI compared to UMEC or VI alone. Baseline is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the Day 14 value minus the Baseline value for that treatment period.|Baseline and Day 14 of each treatment period (up to study day 83)|ITT Population. Only those participants available at the specified time point were analyzed.|||participants|||Number
2646185|NCT01705587|Secondary|Radiologic Healing||at 2, 6, 24, and 48 weeks|Data not collected at 2 and 6 weeks. Twenty-Four week (6 months) data is presented in 6 month outcomes, and 48 week (12 months) data as 12 month outcomes (See primary outcomes section above).||||||
2644742|NCT01716520|Secondary|Number of Participants (Par.) Who Were Responsive to UMEC/VI, UMEC, or VI According to FEV1 at Day 1 of Each Treatment Period (TP)|A responder is a par. with an increase from BL of >=12% and 200 milliliters (mL) at >=1 time point over 0-6 hours post-dose (PD) in FEV1 on Day 1. A non-responder (NR) is a par. with >=1 FEV1 assessment over 0-6 hours PD on Day 1 but no increase from BL of >=12% and 200 mL at any assessment(s). Missing: no FEV1 data recorded over 0-6 hours PD on Day 1. Response type is defined based on a par.'s response to each individual monotherapy treatment. A responder to UMEC is a par. who is a responder in the UMEC treatment period (TP) and either a NR or has missing data in the VI TP. A responder to VI is a par. who is a responder in the VI TP and either a NR or has missing data in the UMEC TP. A responder to UMEC and VI is a par. who is a responder in both the UMEC and VI TPs. A responder to neither is a par. who is a NR in both the UMEC and VI TPs. Missing: a par. who has missing data in both the UMEC and VI TPs, or who has missing data in one monotherapy period and is a NR in the other.|Baseline (BL) and 0-6 hours post-dose (15 minutes, 30 minutes, and 1, 3, and 6 hours post-dose) on Day 1 of each treatment period (up to study day 71)|ITT Population|||participants|||Number
2644743|NCT01716520|Primary|Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour Forced Expiratory Volume in One Second (FEV1) Obtained Post-dose at Day 14 of Each Treatment Period (TP) by Response Type|FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM FEV1 was calculated using 0-6 hour post-dose measurements at Day 14 of each TP, which included pre-dose (trough value for Day 14 [mean of the 23 and 24 hour assessments post Day 13 dosing]) and post-dose 15 minutes (min), 30 min, and 1, 3, and 6 hours. BL is the mean FEV1 values recorded 30 min and 5 min pre-dose on Day 1 of each TP, mean BL is the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the Day 14 value minus the BL value for that TP. Participants could have been classified as responders to both UMEC and VI.|Baseline and Day 14 of each treatment period (up to study day 83)|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received >=1 dose of randomized study medication in a TP. Only par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number of par, analyzed reflects everyone in the ITT Population.|||Liters||Standard Error|Least Squares Mean
2644744|NCT01716468|Primary|To Determine the Safety and Tolerability of a Modified Low Carbohydrate Diet in People With Advanced Cancer Across Different Tumor Types.|Recent studies involving human patients with brain cancer showed tolerability of the Ketogenic diet over a period as long as 19 months with minimal side effects. It is hypothesized that the effect this diet will have on overall weight loss, hyperlipidemia, and blood glucose levels will be minimal and tolerable even by cancer patients over a prolonged period of time, up to 12 months or possibly longer. Serum fasting glucose, cholesterol, total, LDL, HDL and triglycerides, serum ketones in mg/dl units , weight in lbs. will be measured at designated time points. Number of patients actually tolerating the diet for at least 4 weeks or more will be recorded.|16 weeks|Solid cancers or blood cancers with measurable components in advanced or metastatic stages.|||participants|||Number
2644745|NCT01716455|Primary|Maximum Plasma Concentration (Cmax) of SSP-004184|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Over 96 hours post-dose|The Pharmacokinetic Analysis Set is defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data are considered sufficient and interpretable. The Safety Analysis Set consists of all enrolled subjects who take at least 1 dose of investigational product and have at least 1 post dose safety assessment.|||ng/ml||Standard Deviation|Mean
2644746|NCT01716455|Primary|Area Under the Plasma Concentration-time Curve (AUC) of SSP-004184|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 96 hours post-dose|The Pharmacokinetic Analysis Set is defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data are considered sufficient and interpretable. The Safety Analysis Set consists of all enrolled subjects who take at least 1 dose of investigational product and have at least 1 post dose safety assessment.|||ng*hr/ml||Standard Deviation|Mean
2644747|NCT01716234|Secondary|Number of Participants With an Adverse Event Leading to Study Drug Discontinuation|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.|Up to Day 28|The population analyzed was all treated participants.|||Participants|||Number
2644748|NCT01716234|Secondary|Number of Participants With an Adverse Event|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of preexisting conditions.|Up to Day 58|The population analyzed was all treated participants.|||Participants|||Number
2644749|NCT01716234|Primary|Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)|Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 7 (steady state). The 12-hour sample was not obtained for the TID dose groups. The target Cavg range was 500 to <2500 ng/mL.|Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose|The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.|||ng/mL||Standard Deviation|Mean
2644750|NCT01716234|Primary|Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)|Blood samples for determination of plasma posaconazole concentration were collected predose and approximately 3, 5, 8, and 12 hours after the first dose on Day 1. The 12-hour sample was not obtained for the TID dose groups. Day 1 pharmacokinetic samples were not collected for participants 3 months to <2 years of age weighing <6.5 kg.|Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups)|The pharmacokinetic evaluable population included all treated participants with evaluable samples applicable to the endpoint.|||ng/mL||Standard Deviation|Mean
2646230|NCT01705080|Secondary|Mean Change in Office Diastolic Blood Pressure at 12 Months||Baseline and 12 months||||mmHg||Standard Deviation|Mean
2644751|NCT01716221|Other Pre-specified|Hamilton Depression Rating Scale|The Hamilton Depression Rating Scale is a 21 item questionnaire scored each item on a scale of 0 to 3 or 5. The max score is 66. Higher scores indicate worsened depression. All items are summed together to give a total score. A total score of 0-7 is considered normal, while total scores greater than 20 are indicative of moderate or greater depression.|Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)||||units on a scale|||Number
2644752|NCT01716221|Secondary|Comparison of FARS and ICARS|Differences between FARS - ICARS at each treatment interval|Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)||||points|||Number
2644753|NCT01716221|Primary|Friedreich Ataxia Rating Scale (FARS)|A rating scale developed for Friedreich ataxia in evaluation of ataxia. Score range from 0-159 with a score of 0 meaning normal and greater scores indicating worsened disease.|Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)||||points|||Number
2644754|NCT01716221|Primary|International Cooperative Ataxia Rating Scale (ICARS)|The ICARS is a 19 item rating scale of ataxia with the total score ranging from 0 to 100. A score of 0 means normal and higher scores represent worsened disease.|Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 weeks (bupropion), and 20 weeks (citalopram + bupropion)||||units|||Number
2644755|NCT01716169|Primary|Percentage of Wound Surface Area Change From Baseline to Week 8|Change was assessed in terms of wound surface area, as measured using the ARANZ camera. Week 8 surface area measurement was compared to baseline surface area measurement and percentage in size change was calculated.|Baseline and Week 8||||percentage of wound surface area||95% Confidence Interval|Mean
2644756|NCT01716156|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR 24)|HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA <25 IU/mL 24 weeks after the end of all study therapy.|Up to Week 48|Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
2644757|NCT01716156|Secondary|Percentage of Participants With Sustained Virologic Response 4 Weeks After Ending Study Therapy (SVR4)|HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA <25 IU/mL 4 weeks after the end of all study therapy.|Up to Week 28|Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
2644758|NCT01716156|Secondary|Percentage of Participants With HCV RNA <25 IU/mL by Time Point|HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.|From Week 2 through end of treatment (up to 24 weeks)|Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
2644759|NCT01716156|Secondary|Percentage of Participants With Undetectable HCV RNA by Time Point|HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment (End of Treatment Response). The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.|From Week 2 through end of treatment (up to 24 weeks)|Per protocol population, per assigned treatment duration. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
2644760|NCT01716156|Secondary|Time to Achievement of First Undetectable HCV RNA|The mean time (in days) to first achievement of undetectable HCV RNA was assessed using Kaplan-Meier plot and summary statistics. HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as below the limit of detection of 9.3 IU/mL.|Up to Week 24|Full analysis set consists of all randomized participants receiving ≥1 dose of study therapy.|||Days||Standard Error|Mean
2644761|NCT01716156|Primary|Percentage of Participants Discontinuing Study Therapy Due to an AE|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment.|Up to 24 weeks|The APaT population included all randomized participants who received at least 1 dose of study therapy.|||Percentage of participants|||Number
2644777|NCT01716104|Secondary|Percent Change in Mean Values of Prostate Gland Volume at 3, 6 and 12 Months Compared to Baseline|Change in the volume of the prostate gland as a percentage of the baseline according to transrectal ultrasound|Baseline and 3, 6 and 12 months|ITT set|||percentage of prostate gland volume||Standard Deviation|Mean
2644762|NCT01716156|Primary|Percentage of Participants Experiencing at Least One Adverse Event (AE) on Study|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. Data are presented according to actual treatment duration (12 weeks or 24 weeks) regardless of participants' initial arm assignment.|Fourteen days following last dose of study drug (up to 26 weeks)|The All Participants as Treated (APaT) population included all randomized participants who received at least 1 dose of study therapy.|||Percentage of participants|||Number
2644763|NCT01716156|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)|SVR12 was defined as HCV RNA <25 IU/mL 12 weeks after the end of all study therapy. HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL.|Up to Week 36|Per protocol population, as randomized. Per protocol population consists of all randomized participants receiving ≥1 dose of study therapy and no important protocol deviations.|||Percentage of participants||95% Confidence Interval|Number
2644764|NCT01716117|Post-Hoc|Post-Hoc Primary Safety Endpoint of Disabling Stroke or Neurologic Death Through 12 Month Follow-Up|Subjects experiencing neurologic death or disabling stroke through 12 months.|12 Months|mITT Population|||Percent of participants||95% Confidence Interval|Number
2644765|NCT01716117|Other Pre-specified|Number of Surpass Streamline Flow Diverters Implanted Per Subject in SCENT Trial - mITT and Roll-In Populations|Number of devices implanted in subjects by study population|12 Months||||Participants|||Count of Participants
2644766|NCT01716117|Other Pre-specified|CEC Adjudicated Primary Effectiveness Endpoint Outcomes for Giant and Non-Giant (Large) Intracranial Aneurysms Through 12 Month Follow-Up - mITT Population|Primary effectiveness by intracranial aneurysm size|12 Months|mITT Population|||Participants|||Count of Participants
2644767|NCT01716117|Other Pre-specified|Subgroup Analysis of Primary Effectiveness Endpoint Based on Subject Age ≥ 65 Years Versus < 65 Years in mITT Population|Primary effectiveness by age group|12 Months|mITT population|||Participants|||Count of Participants
2644768|NCT01716117|Other Pre-specified|Clinical Events Committee (CEC) Adjudicated Rate of Minor Strokes Through 12 Month Follow-Up|Patients with minor strokes through 12 months|12 Months|Secondary endpoint analysis of the mITT population (n = 180) are presented herein for comparison to results of subjects in the Roll-in population (n = 33).|||Participants|||Count of Participants
2644769|NCT01716117|Secondary|Raymond-Roy Score Per Core Lab Assessment Based on Device Apposition at 12 Months Post-Procedure|The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete obliteration (best); Class II: residual neck; Class III: residual aneurysm (worse).|12 months|mITT population|||Participants|||Count of Participants
2644770|NCT01716117|Primary|mITT Primary Safety Endpoint. Based on Subjects Experiencing Neurologic Death or Major Ipsilateral Stroke Through 12 Month Follow-up.|Subjects experiencing neurologic death or major ipsilateral stroke through 12 months.|12 months|The mITT primary endpoint analysis population (n = 180) is based on subjects in the mITT arm and does not include the results of subjects treated in the Roll-in arm (n = 33).|||Participants|||Count of Participants
2644771|NCT01716117|Primary|mITT Primary Effectiveness Endpoint. Based on Subjects With 100% Occlusion of the Aneurysm Without Clinically Significant Stenosis of the Parent Artery, and Without Any Subsequent Treatment of the Target Aneurysm at the 12 Month Follow up Visit.|Percent of subjects with 100% occlusion of the aneurysm without clinically significant stenosis (defined as less than or equal to 50% stenosis) of the parent artery based on core lab evaluation of the 12 month follow up angiogram and without any subsequent treatment of the target aneurysm at the 12 month follow up visit.|12 months|The mITT primary endpoint analysis population (n = 180) is based on subjects in the mITT arm and does not include the results of subjects treated in the Roll-in population (n = 33).|||Percent of participants||95% Confidence Interval|Number
2644772|NCT01716104|Secondary|Number of Episodes of Acute Urinary Retention, Surgical Intervention During the Observation Period||12 months|ITT set|||episodes|||Number
2644773|NCT01716104|Secondary|Change in Total Value of Risk Factors for Progression (Total Score of IPSS, Prostate Volume, PSA Level, Maximum Urinary Flow Rate, Residual Urine Volume) Compared to Baseline|"To assess the risk of BPH progression, the following were used: 1) moderate to severe BPH symptoms (ie, IPSS total score> 7); 2) an increase in the volume of the prostate gland (> 30 cm^2); 3) increased PSA level in the blood (≥ 1.4 ng / ml); 4) a decrease in Qmax (<12 ml / s) and 5) a large volume of residual urine (> 200 ml).~The total value of risk factors for progression is assessed as the sum of the risk factors that the patient had at the time of inclusion in the study (presence of risk factors = 1 point, absence = 0 points). After 3, 6 and 12 months of treatment, the dynamics of risk factors for progression was assessed: an increase in the severity of the risk factor meant +1, no change = 0, a decrease in the severity of the risk factor of -1."|Baseline and 3, 6 and 12 months|ITT set|||Scores||Standard Deviation|Mean
2644774|NCT01716104|Secondary|Change in Quality of Life (QoL Index of IPSS) at 3, 6 and 12 Months Compared to Baseline|"Quality of life (QoL) Due to Urinary Symptoms is an eight point of the IPSS scale referred to the patient's quality of life. The answers to this question range from delighted to terrible or 0 to 5."|Baseline and 3, 6 and 12 months|ITT set|||Scores on a scale||Standard Deviation|Mean
2644775|NCT01716104|Secondary|Change in the Mean Values of Residual Urine Volume at 3, 6 and 12 Months Compared to Baseline|according to transabdominal ultrasound|Baseline and 3, 6 and 12 months|ITT set|||ml||Standard Deviation|Mean
2644776|NCT01716104|Secondary|Change in Mean Values of Micturition Volume at 3, 6 and 12 Months Compared to Baseline||Baseline and 3, 6 and 12 months|ITT set|||ml||Standard Deviation|Mean
2644778|NCT01716104|Secondary|Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline||Baseline and 1, 3, 6 and 12 months|ITT set|||ml/s||Standard Deviation|Mean
2644780|NCT01716104|Secondary|Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline|"The International Prostate Symptom Score (IPSS) is based on the answers to 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) was evaluated separately in this clinical study.~The sum of IPSS questions 2, 4, and 7 related to irritative symptoms. The total score of irritative symptoms can therefore range from 0 to 15 points (asymptomatic to very symptomatic)."|Baseline and 1, 3, 6, 12 months|ITT set|||Scores on a scale||Standard Deviation|Mean
2644781|NCT01716104|Primary|Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline.|The International Prostate Symptom Score (IPSS) is based on the answers to 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) was evaluated separately in this clinical study.|Baseline, 1, 3, 6 and 12 months|ITT set|||Scores on a scale||Standard Deviation|Mean
2644782|NCT01716052|Primary|Measure of Discomfort of Mammography|The primary outcome measure will be the response to questions on a questionnaire.|3 years|No data was collected or analyzed for the outcome measure because the study was terminated.||||||
2644783|NCT01716013|Other Pre-specified|Wound Dehiscence Requiring Treatment|Wound dehiscence requiring treatment; i.e., need for supplemental closure due to dehiscence at any time, from closure through follow-up|28 Days and 90 days|Intent-to-Treat (ITT) population|||percentage of participants|||Number
2644784|NCT01716013|Secondary|≥ 50% Wound Apposition at 10 Days|Incidence of wounds ≥50% apposed (10 ± 3 days)|10 days|Intent-to-treat (ITT) population|||percentage of participants|||Number
2644785|NCT01716013|Secondary|Optimal Cosmetic Outcome at 28 Days (Score of 6)|"Incidence of wounds with an optimal cosmetic outcome (score of 6) at 28 days.~One point was scored for the absence of, and no point was scored for the presence of, any of the following six items:~Stepoff of borders (edges not on the same plane)~Contour irregularities (wrinkled skin near wound)~Margin separation (gap between sides)~Edge inversion (wound not properly everted)~Excessive distortion (swelling or edema or infection)~Poor overall appearance.~The overall cosmesis score was determined by adding the scores of each individual item. An overall score of six was considered an optimal score outcome. Any score below six was considered suboptimal."|28 days|Intent-to-treat (ITT) population|||percentage of participants|||Number
2644786|NCT01716013|Primary|100% Wound Apposition at 10 Days|Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure.|10 days|Per protocol population (primary analysis dataset)|||percentage of participants|||Number
2644787|NCT01715948|Primary|Speech Spatial Qualities Questionnaire (SSQ)|"The Speech Spatial Qualities Questionnaire (SSQ) was given to assess the self-perceived benefits provided by the device that was worn the previous 2 weeks. The SSQ requires participants to rate their perceived hearing ability for 49 scenarios using a 10-point scale, ranging from 0 (Not at all) to 10 (Perfectly). A score higher than 0 for each listening scenario shows some benefit of the device, while a score of 10 indicates the device was extremely beneficial. Therefore, a lower score indicated poorer self-perceived benefit from the device (representing a worse outcome), while a higher score indicated greater self-perceived benefit from the device (representing a better outcome). To obtain individual scores for the SSQ questionnaire, the ratings for each listening scenario were summed. The mean, minimum and maximum scores for each subscale of the SSQ across all participants were also determined."|Administered at the end of a 2 week trial with the CROS and at the end of a 2 week use of the BAHD.||||units on a scale||95% Confidence Interval|Mean
2644788|NCT01715948|Primary|Percentage of Words Recognized|Word recognition was tested with the recorded version of the Central Institute for the Deaf (CID) W-22 (Auditec of St. Louis), with a different list of 25 monosyllabic words presented at 50 dB HL in three randomized listening conditions. In the first condition, one list was presented at 50 dB HL at 90 degrees to the poor ear in quiet. In the second condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was presented at 45 dB HL at 90 degrees to the poor ear. In the final condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was delivered at 45 dB HL at 90 degrees to the better ear.|Word recognition testing (unaided) occurred at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested)..|The researchers chose not to include a condition with words presented at 90 degrees to the better ear in quiet.|||Percentage of words perceived correctly||95% Confidence Interval|Mean
2644789|NCT01715948|Primary|Number of 5 Key Words Within 6 Sentence Lists Repeated Correctly in the Presence of Multitalker Noise|One speech-in-noise test (QuickSIN) presented four lists of six pre-recorded sentences at 50 dB hearing level (HL) in soundfield. Multitalker noise was presented together with the target sentence and increased at a fixed number of dB with the completion of each sentence. The multitalker noise was initially presented at 25 dB HL (signal-to-noise ratio - SNR of 25 dB), and increased by 5 dB after each sentence until the multitalker noise was of equal intensity with the final sentence (SNR of 0 dB). In one condition, two lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the poor ear. In the other condition, two different lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the better ear. The two scores derived from the two different lists of sentences presented within each condition were averaged. A low score indicates better performance.|The QuickSIN unaided was administered at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested).||||words||95% Confidence Interval|Mean
2644790|NCT01715896|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab|Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays.|Day 1 to Day 169|The immunogenicity population included all participants who received at least 1 dose of mavrilimumab and for whom at least one serum sample for immunogenicity testing was available.|||participants|||Number
2646231|NCT01705080|Secondary|Mean Change in Office Diastolic Blood Pressure at 6 Months||Baseline and 6 months||||mmHg||Standard Deviation|Mean
2644791|NCT01715896|Secondary|Serum Concentrations of Mavrilimumab|Serum concentrations after subcutaneous dose of mavrilimumab were calculated|Baseline, Day 8, 15, 29, 85, 141, and 169|"The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here n signifies participants who were evaluable for the specified time point for each this arm respectively."|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2644792|NCT01715896|Secondary|Erythrocyte Sedimentation Rate (ESR) at Day 169|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. The farther the red blood cells have descended, the greater the inflammatory response.|Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (Number of participants analyzed) signifies those participants who were evaluable for this measure. n'' signifies participants evaluable for specified category for each arm, respectively."|||millimeter per hour (mm/h)||Standard Deviation|Geometric Mean
2644793|NCT01715896|Secondary|Ratio of Change C-Reactive Protein (CRP) at Day 169 to Baseline|The ratio of change from baseline for CRP was analyzed and reported. The CRP is a substance produced by the liver that increases in the presence of inflammation in the body. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in underlying disease.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (Number of participants analyzed) signifies those participants who were evaluable for this measure."|||ratio||Geometric Coefficient of Variation|Geometric Mean
2644794|NCT01715896|Secondary|Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
2644795|NCT01715896|Secondary|Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169|Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||centimeter (cm)||Standard Error|Mean
2644796|NCT01715896|Secondary|Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169|"Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 mm VAS, where 0 = very well and 100 = very poorly."|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||mm||Standard Error|Mean
2644797|NCT01715896|Secondary|Mean Change From Baseline in Patient Assessment of Pain at Day 169|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||millimeter (mm)||Standard Error|Mean
2644798|NCT01715896|Secondary|Mean Change From Baseline in Swollen and Tender Joint Count at Day 169|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1. Mean here indicates adjusted mean.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||joint count||Standard Error|Mean
2644799|NCT01715896|Secondary|Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169|The ACR/EULAR remission was defined as swollen joint count (0-66), tender joint count (0-68), CRP (mg/dL) and participant global assessment (0-10) all less than or equal to one.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
2644800|NCT01715896|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169|The CDAI was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS. The CDAI total score ranges from 0 to 76 where higher scores indicates greater affection due to disease activity. CDAI remission was defined as a score less than or equal to 2.8.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
2644830|NCT01715857|Secondary|Time to Extubation|Time to extubation was measured from the time sevoflurane administration had stopped until tracheal extubation or laryngeal mask airway (LMA) removal occurred.|From cessation of sevoflurane administration until tracheal extubation occurred, up to 80 minutes|All participants who received study drug and with available data.|||minutes||Standard Deviation|Mean
2644801|NCT01715896|Secondary|Percentage of Participants Who Achieved Simplified Disease Activity Index (SDAI) Remission at Day 169|The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 centimetre (cm) VAS; and C-reactive protein (CRP) (milligram per deciliter [mg/dL]). The SDAI total score ranges from 0 to 86, where higher scores indicates greater affection due to disease activity. SDAI remission was defined as a score less than or equal to 3.3. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
2644802|NCT01715896|Secondary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) < 2.6 at Day 169|The DAS28 (ESR) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]). Total score range: 0-9.4, higher score = more disease activity. DAS28 (ESR) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
2644803|NCT01715896|Secondary|Duration of DAS28 (CRP) Remission at Day 169|The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Participants with score less than 2.6 were analysed. Duration of DAS28(CRP) remission for each subject was defined as number of days from onset of remission to when the subject was no longer in remission.|Day 169|"The mITT population analysis set included all participants who were at risk in the treatment group corresponding to their randomized treatment group. Here, N is number of participants analysed for this outcome measure."|||days||Standard Error|Mean
2644804|NCT01715896|Secondary|Time to Onset DAS28 (CRP) Remission at Day 169|The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the VAS of 0 (= best), 100 (= worst) plus levels of CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) <3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Participants with score less than 2.6 were analysed. Onset of DAS28(CRP) remission ≤ 2.6 defined as the first study day in which the DAS28 score met the criteria.|Day 169|"The mITT population analysis set included all participants who were at risk in the treatment group corresponding to their randomized treatment group. Here, N is number of participants analysed for this outcome measure."|||days||90% Confidence Interval|Median
2644805|NCT01715896|Secondary|Number of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169|DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. Remission was defined as less than 2.6 DAS28 (CRP) score. Low disease activity was defined as less than 3.2 DAS28 (CRP) score.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||participants|||Number
2644806|NCT01715896|Secondary|Number of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169|DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to less than or equal to (=<) 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||participants|||Number
2644807|NCT01715896|Secondary|American College of Rheumatology (ACR) Hybrid Score at Day 169|ACR Hybrid score was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||units on a scale||Full Range|Median
2644808|NCT01715896|Secondary|Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169|ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement. Mean indicates adjusted mean (Adj mean).|Baseline up to Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
2644831|NCT01715857|Secondary|Time to Eye Opening|After cessation of anesthesia, the investigators lightly tapped on the participant's forehead or shoulder and asked the participant to open their eyes. This process was repeated approximately every minute until eye opening occurred.|From cessation of sevoflurane administration until the participant opened their eyes, up to 80 minutes|All participants who received study drug and with available data.|||minutes||Standard Deviation|Mean
2667291|NCT01516879|Secondary|Change From Baseline in LDL-C at Week 52|Cholesterol was measured by means of ultracentrifugation.|Baseline and Week 52|Full Analysis Set|||mg/dL||Standard Error|Least Squares Mean
2644809|NCT01715896|Secondary|Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 169|DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, greater than or equal to (>=) 3.2 to 5.1 = moderate to high disease activity and <2.6= remission.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively"|||units on a scale||Standard Deviation|Mean
2644810|NCT01715896|Secondary|Dyspnea Score at Day 169|Borg dyspnea scale was a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing.|Day 169|"The safety population included all participants who received any amount of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||units on a scale||Standard Deviation|Mean
2644811|NCT01715896|Secondary|Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169|Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), forced vital capacity (FVC), and diffusing capacity for carbon monoxide (DLCO). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. DLCO is a pulmonary function test that measures the partial pressure difference between inspired and expired carbon monoxide. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as more than (>) 20% reduction (RD) and absolute value (AV) less than (<) 80% predicted (PR).|Day 85 and 169|"The safety population included all participants who received any amount of investigational product. Here n signifies participants who were evaluable for this measure for the specified threshold value mentioned parameter for each arm, respectively."|||participants|||Number
2644812|NCT01715896|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported.|Baseline up to Day 169|The safety population included all participants who received any amount of study medication.|||participants|||Number
2644813|NCT01715896|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)|Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (leukocytosis, neutropenia, anaemia of chronic disease); serum chemistry (alanine aminotransferase, blood parathyroid hormone, gamma glutamyl transferase, hepatic enzyme, dyslipidaemia, hypercholesterolaemia, hyperglycaemia, hyperlipidaemia, hypertriglyceridaemia); urinalysis.|Baseline up to Day 169|The safety population included all participants who received any amount of investigational product.|||participants|||Number
2644814|NCT01715896|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pre-treatment state. TEAE and TESAE were reported as per relatedness and severity.|Baseline up to Day 169|The safety population included all participants who received any amount of study medication.|||participants|||Number
2644815|NCT01715896|Primary|Percentage of Participants Who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement From Baseline and >= 0.25 at Day 169|The HAQ-DI: 20-item scale assessing participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arising, eating, hygiene, walking, reaching, grip, and errands/chores over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty. Participants with change from baseline more than or equal to (>=) 0.25 were reported. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
2644816|NCT01715896|Primary|Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169|The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the visual analogue scale (VAS) of 0 (= best), 100 (= worst) plus levels of CRP (milligram/Liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, >=3.2 to 5.1 = moderate to high disease activity and <2.6= remission. Participants with score less than 2.6 were analysed. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
2644832|NCT01715857|Primary|Participant Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)|Participant satisfaction with the anesthesia recorded approximately 24 hours after the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied).|24 hours after end of surgery|All participants who received study drug and with available data.|||scores on a scale||Standard Deviation|Mean
2644817|NCT01715896|Primary|Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169|The ACR70 was defined as >=70% improvement, in: SJC and TJC and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
2644818|NCT01715896|Primary|Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169|The ACR50 was defined as >=50% improvement, in: SJC and TJC and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
2644819|NCT01715896|Primary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169|The ACR20 was defined as greater than or equal to (>=) 20 percent (%) improvement, in: swollen joint count (SJC) and tender joint count (TJC) and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity (MDGA); self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-reactive protein (CRP). If CRP was missing and Erythrocyte sedimentation rate (ESR) was present then ESR was to be used.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
2644820|NCT01715883|Secondary|Number of ICU Free Days (IFD)|Defined as the number of days outside the ICU through Day 30 post transplantation.|Day 30 post transplantation.||||days||Standard Deviation|Mean
2644821|NCT01715883|Secondary|Number of Ventilator Free Days (VFD)|Defined as the number of days off mechanical ventilation at baseline through Day 30 post transplantation.|Baseline through Day 30 post transplantation.||||days||Standard Deviation|Mean
2644822|NCT01715883|Secondary|Number of Participants With Chronic Rejection|To evaluate the efficacy of Sodium Nitrite infusion into the procured lungs and the lung transplant recipient in the prevention of delayed allograft complications including the incidence of chronic rejection. Prevention of delayed allograft complications include clinically indicated spirometric and lung volume assessments of lung function performed as an indicator of Bronchiolitis Obliterans Syndrome (BOS), and evidence of pathological rejection by surveillance transbronchial lung biopsies.|Up to 12 months post lung transplant||||Participants|||Count of Participants
2644823|NCT01715883|Secondary|Number of Participants With Acute Rejection|To evaluate the efficacy of Sodium Nitrite infusion into the procured lungs and the lung transplant recipient in the prevention of delayed allograft complications including the incidence of acute rejection. Prevention of delayed allograft complications include clinically indicated spirometric and lung volume assessments of lung function performed as an indicator of Bronchiolitis Obliterans Syndrome (BOS), and evidence of pathological rejection by surveillance transbronchial lung biopsies.|Up to 12 months post lung transplant||||Participants|||Count of Participants
2644824|NCT01715883|Secondary|Number of Participants With Primary Graft Dysfunction Grades 2+3|The primary study endpoint is the incidence of grades 2+3 Primary Graft Dysfunction (PGD) based upon the worst PGD grade during the first 72 hours post organ reperfusion. The severity of PGD is graded 0-3 based on the presence or absence of diffuse opacities on chest radiograph and the ratio of arterial oxygen pressure to inspired oxygen concentration. The grading system predicts post-lung transplant outcomes with Grade 3 being the worst.|First 72 hours post organ reperfusion.||||Participants|||Count of Participants
2644825|NCT01715883|Primary|Safety of Sodium Nitrite Administration - Number of Participants With Fall in Patient's Mean Arterial Pressure Greater Than 20%|The safety of Sodium Nitrite administration will be assessed by the incidence of fall in patient's Mean Arterial Pressure greater than 20% from recorded baseline requiring discontinuation of drug infusion during and after the nitrite infusion in the transplant recipient. Mean Arterial Pressure will be monitored at 1 minute intervals during study drug infusion followed by 15 minute intervals for 1 hour.|Baseline and 1 hour post infusion||||Participants|||Count of Participants
2644826|NCT01715883|Primary|Safety of Sodium Nitrite Administration Measured by Methemoglobin Levels|The safety of Sodium Nitrite administration will be assessed by methemoglobin levels during and 150 minutes after the nitrite infusion in the transplant recipient.|150 minutes post infusion||||percentage of methemoglobin||Standard Deviation|Mean
2644827|NCT01715857|Secondary|Non-compliance of Sevoflurane Vaporizer Setting Following the Consensus|Non-compliance of sevoflurane vaporizer setting was defined as the percentage of time points for the maintenance period outside the range of 1.0 - 1.5 minimal alveolar concentration (MAC) during the maintenance period (excluding washout phase) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.|During maintenance (up to 5 hours)|All participants who received study drug and with available data.|||percentage of timepoints|Participants||Number
2644828|NCT01715857|Secondary|Non-compliance of Sevoflurane End Tidal Concentration Following the Consensus|Non-compliance of sevoflurane end tidal concentration was defined as the percentage of time points for the maintenance period (excluding washout phase) that were below the sevoflurane end tidal concentration boundary of 0.6 minimal alveolar concentration (MAC) based on the Consensus. A higher percentage indicates a higher degree of non-compliance.|During maintenance (up to 5 hours)|All participants who received study drug and with available data.|||percentage of timepoints|Participants||Number
2644829|NCT01715857|Secondary|Cost of Anesthetics Including Sevoflurane (Yuan Renminbi [RMB]/Hour)|Cost of anesthetics is the sum of the cost of sevoflurane and other anesthetics including narcotics and muscle relaxants. Cost of sevoflurane = unit price of sevoflurane multiplied by the used volume of sevoflurane. Cost of other anesthetics = unit price of anesthetics multiplied by the total volume of anesthetics in the ampoule.|Anesthetic duration between 1 to 5 hours|All participants who received study drug and with available data.|||Yuan renminbi [RMB]/hour||Standard Deviation|Mean
2644833|NCT01715857|Primary|Anesthesiologist Satisfaction With the Anesthesia Using a Numeric Analog Scale (NAS)|Anesthesiologist satisfaction with the anesthesia was recorded by the anesthesiologist at the end of the operation using a NAS from 0 (not satisfied at all) to 10 (completely satisfied). The satisfaction of induction, maintenance, and emergence accounts for 20%, 50%, and 30% of the score, respectively.|End of surgery||||scores on a scale||Standard Deviation|Mean
2644834|NCT01715831|Secondary|ESR Level|ESR is an acute phase reactant and is a measure of inflammation.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||mm/hr||Standard Deviation|Mean
2644835|NCT01715831|Secondary|C-Reactive Protein (CRP) Level|CRP is an acute phase reactant and is a measure of inflammation.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2644836|NCT01715831|Secondary|Health Assessment Questionnaire (HAQ) Pain VAS Score|The HAQ pain VAS is a measure of pain on a continuous 100 mm scale. Participants were asked to indicate how much pain they had in the past week as a result of their illness on a horizontal line from 0 (no pain) to 100 mm (severe pain).|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||mm||Standard Deviation|Mean
2644837|NCT01715831|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|The Stanford HAQ-DI is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/personal care, ability to stand-up, eating, walking, hygiene, reaching, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents 'no disability' and 3 represents 'very severe, high-dependency disability'.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
2644838|NCT01715831|Secondary|Participant's Pain Assessment Using VAS Score|"Participant's pain assessment was made on a horizontal 0-100 mm VAS, with 0 mm (left end of the line) described as no pain and 100 mm (right end of the line) as unbearable pain. The participant marked the line according to their assessment and the distance from the left edge was measured."|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||mm||Standard Deviation|Mean
2644839|NCT01715831|Secondary|Global Evaluation of Disease Activity by the Physician Using VAS Score|"Physician global assessment of disease activity was measured on a horizontal 0-100 mm VAS, with 0 mm (left end of the line) described as inactive disease (free of symptoms and without symptoms of arthritis) and 100 mm (right end of the line) as disease maximum activity (maximum activity of arthritis). The physician marked the line according to their assessment and the distance from the left edge was measured."|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||mm||Standard Deviation|Mean
2644840|NCT01715831|Secondary|Global Evaluation of Disease Activity by the Participant Using VAS Score|"Participant's global assessment of disease activity was measured on a horizontal 0-100 mm VAS, with 0 mm (left end of the line) described as inactive disease (free of symptoms and without symptoms of arthritis) and 100 mm (right end of the line) as disease maximum activity (maximum activity of arthritis). The participant marked the line according to their assessment and the distance from the left edge was measured."|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||mm||Standard Deviation|Mean
2644841|NCT01715831|Secondary|Swollen Joint Count (SJC)|An assessment of 28 joints was conducted for swelling. Joints were assessed and classified as swollen/not swollen by pressure and joint manipulation after a physical examination. Artificial joints, arthrodesis or fused joints were not taken into consideration for swelling.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||swollen joints||Standard Deviation|Mean
2644842|NCT01715831|Secondary|Tender Joint Count (TJC)|An assessment of 28 joints was conducted for tenderness. Joints were assessed and classified as tender/not tender by pressure and joint manipulation after a physical examination. Artificial joints, arthrodesis or fused joints were not taken into consideration for tenderness.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||tender joints||Standard Deviation|Mean
2644843|NCT01715831|Secondary|Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)|DAS28 score is a measure of participant's disease activity calculated using tender joint count in 28 joints (TJC28), swollen joint count in 28 joints (SJC28), participant's global assessment of disease activity (general health [GH]) using visual analog scale (VAS), 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (erythrocyte sedimentation rate [ESR] in millimeters per hour [mm/hr]) for a total possible score of 0 to 10. The score is calculated using the following formula: DAS28 = [0.56 multiplied by (*) square root (√) of TJC28] plus (+) [0.28*√SJC28]+[0.70*the natural logarithm (ln) ESR]+[0.014*GH]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and follow-up (FU) Visit 1 (Week 108), FU Visit 2 (Week 116)|ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
2644893|NCT01715129|Secondary|Time to Achieve Castration (Tcast)|Time to castration (Tcast) from first administration date until first observed serum testosterone level <50 ng/dL or <1.735 nmol/L evaluated using the immunoassay method only (i.e. defined as the number of days between the injection time at Day 1 and castration achievement)|Up to Day 36|ITT population|||Day||95% Confidence Interval|Median
2644844|NCT01715831|Primary|Number of Participants With AEs of Special Interest|Adverse events of special interest included following events: Infections (including opportunistic infections); myocardial infarction / acute coronary syndrome; gastrointestinal (GI) perforations and related events; malignancies; anaphylaxis/hypersensitivity reactions; demyelinating disorders; stroke; hemorrhagic events; and hepatic events. Overall number of participants who experienced any of these AEs of special interest was reported.|From Baseline up to approximately 2 years|ITT population|||participants|||Number
2644845|NCT01715831|Primary|Number of Participants With AEs Leading to Dose Modification or Study Discontinuation||From Baseline up to approximately 2 years|ITT population|||participants|||Number
2644846|NCT01715831|Primary|Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (NSAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; significant medical event, according to the investigator discretion (e.g., may represent a risk to the participant or may require medical/surgical intervention to prevent one of the outcomes mentioned above).|From Baseline up to approximately 2 years|ITT population|||participants|||Number
2644847|NCT01715805|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Score in the Double-Blind Period|The Sheehan Disability Scale (SDS) is a 3-item patient-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum from 0 (no impairment) to 10 (most severe). The 3 individual scores are summed for a total possible score of 0 (unimpaired) to 30 (highly impaired). A negative change from Baseline indicates improvement. MMRM with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.|Baseline (Week 8) to Week 16|Double-blind ITT Population included all participants in the double-blind safety population who had a randomization baseline assessment and at least 1 postbaseline assessment of the MADRS total score during the double-blind treatment period.|||score on a scale||Standard Error|Least Squares Mean
2644848|NCT01715805|Primary|Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in the Double-Blind Period|The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Participants are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60. A negative change from Baseline indicates improvement. Mixed-effects model for repeated measures (MMRM) with treatment group, study center, visit, and treatment group-by-visit interaction as fixed effects, and the baseline value and baseline by-visit interaction as the covariates was used for analyses.|Baseline (Week 8) to Week 16|Double-blind ITT Population included all participants in the double-blind safety population who had a randomization baseline assessment and at least 1 postbaseline assessment of the MADRS total score during the double-blind treatment period.|||score on a scale||Standard Error|Least Squares Mean
2644849|NCT01715805|Primary|Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline in the Double-Blind Period|The MADRS is a clinician-rated scale to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity for a total possible score of 0 to 60.|Baseline (Week 8)|Double-blind Intent-to-Treat (ITT) Population included all participants in the double-blind safety population who had a randomization baseline assessment and at least 1 postbaseline assessment of the MADRS total score during the double-blind treatment period.|||score on a scale||Standard Deviation|Mean
2644850|NCT01715415|Secondary|Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.|Within 12 weeks post-treatment|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.|||percentage of participants||95% Confidence Interval|Number
2644851|NCT01715415|Secondary|Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm|Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.|||percentage of participants||95% Confidence Interval|Number
2644852|NCT01715415|Secondary|Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1b who received at least 1 dose of blinded study drug. 1 participant, who had genotype 1 HCV with an indeterminate subgenotype, is not included in this analysis.|||percentage of participants|||Number
2644907|NCT01714947|Secondary|Percentage of Alisertib Metabolites in Urine Following a Single Dose of [^14C]-Alisertib Oral Solution|Total radioactive peak distributions of metabolites in 0 to 192 hours pooled urine samples from participants.|Predose and multiple timepoints post-dose (0 to 192 hours)|PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||percent of dose|||Number
2644853|NCT01715415|Secondary|Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1a who received at least 1 dose of blinded study drug. 1 participant, who had genotype 1 HCV with an indeterminate subgenotype, is not included in this analysis.|||percentage of participants|||Number
2644854|NCT01715415|Secondary|Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period|Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.|At 12 weeks|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug and had ALT ≥ ULN of the reference range at baseline were included in the analysis.|||percentage of participants|||Number
2644855|NCT01715415|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of active study drug|Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug.|||percentage of participants|||Number
2644856|NCT01715298|Secondary|Change From Baseline in Morning and Nighttime Symptom Scores|Patients are reporting morning and nighttime symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. Each question can be answered with one of four pre-defined answers, corresponding to a unit value of 0-3, where 0 stands for the lowest and 3 for the most severe symptom experience. Morning and nighttime symptoms scores for each patient over 12 weeks are reported and analyzed. Symptom scores are calculated as the mean of the symptom scores (morning symptom scores or nighttime symptom scores, respectively) for each patient over 12 weeks (Day 1 to week 12). The baseline is calculated from the run-in epoch prior to randomization. The outcome is calculated as the change from baseline in the morning and nighttime symptom scores, respectively. A negative number indicates a reduction in the symptom severity and is owed to the calculation of the change from baseline.|Day 1 to week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Score||Standard Error|Least Squares Mean
2644857|NCT01715298|Secondary|Change From Baseline in Mean Trough Forced Vital Capacity|Mean trough Forced Vital Capacity (FVC) is assessed as the arithmetic mean of two FVC measurements, conducted within the last hour of a 24 hours period from a morning dose, either that of day 1 or at week 12 of treatment (23:15 h and 23:45 h assessments). The endpoints are the change from baseline in trough FVC on Day 1 and at Week 12, with the mean of the -45 min and -15 min measurements on Day 1 as the baseline.|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Liters||Standard Error|Least Squares Mean
2644858|NCT01715298|Secondary|Change From Baseline in Forced Vital Capacity at All Individual Timepoints|The Forced Vital Capacity (FVC)assessments for all individual time points of the serial measurements on day 1 and at week 12 are analyzed. Serial lung function measurements are taken at the following time points following dosing on Day 1 and at week 12: 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose. For week 12 (day 85), the pre-dose measurements (-45 min and -15 min) and the trough measurements (23:15 h and 23:45 h post-dose) are included. The endpoints are the change from baseline in FVC following the morning dose on Day 1 and at Week 12. Where the FVC at any one timepoint is smaller than at baseline, a negative value can occur.|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Liters||Standard Error|Least Squares Mean
2644859|NCT01715298|Secondary|"Change From Baseline in Percentage of Days Able to Perform Usual Daily Activities"|"Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. One of the symptom questions of the evening questionnaire relates to the impact of COPD symptoms on the performance of usual daily activities (Did your respiratory symptoms stop you performing your usual daily activities today). The answer with the lowest symptom score is not at all. A day able to perform usual daily activities is defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms. The change from baseline in the percentage of days able to perform usual daily activities is calculated from the mean percentage of days with this answer over the 12 week treatment period, with the baseline beingThe baseline is calculated from the run-in epoch prior to randomization."|Day 1 to week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Percentage of days||Standard Error|Least Squares Mean
2644860|NCT01715298|Secondary|"Change From Baseline in the Percentage of Days With no Daytime Symptoms"|"Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. Each question can be answered with one of four pre-defined answers, corresponding to a unit value of 0-3, where 0 stands for the lowest and 3 for the most severe symptom experience. A day with no daytime symptoms is defined from diary data as any day where the patient has recorded in the evening no cough, no wheeze, no production of sputum, and no feeling of breathlessness (other than when running) during the past approximately 12 hours in the evening questionnaire. The change from baseline in the percentage of days with no daytime symptoms is calculated from the mean percentage of days with this answer over the 12 week treatment period, with the baseline being. The baseline is calculated from the run-in epoch prior to randomization."|Day 1 to week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Percentage of days||Standard Error|Least Squares Mean
2644861|NCT01715298|Secondary|"Change From Baseline in the Percentage of Nights With no Nighttime Awakenings"|"Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. One of the symptom questions of the morning questionnaire relates to the number of awakenings due to COPD symptoms during the previous night. The answer with the lowest symptom score is no waking due to symptoms. A night with no nighttime awakening is defined from diary data as any night where the patient did not wake up due to symptoms. The change from baseline in the percentage of nights with no nighttime awakening is calculated from the mean percentage of nights with this answer over the 12 week treatment period, with the baseline being The baseline is calculated from the run-in epoch prior to randomization."|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Percentage of nights||Standard Error|Least Squares Mean
2644862|NCT01715298|Secondary|Change From Baseline in Daily Symptom Scores|Patients are reporting symptoms by using an electronic diary. The electronic diary has 9 symptom questions each morning and each evening. Each question can be answered with one of four pre-defined answers, corresponding to a unit value of 0-3, where 0 stands for the lowest and 3 for the most severe symptom experience. Symptom scores are calculated as the mean of the combined daily symptom scores (combined from morning and evening scores) for each patient over 12 weeks (Day 1 to week 12). The baseline is calculated from the run-in epoch prior to randomization. The change from baseline in the least squares mean daily symptom scores over the 12 week treatment period is provided. Where the mean daily symptom score over the 12 week treatment period is lower than the baseline, the result is negative. A negative result indicates an improvement in COPD symptom severity.|day 1 to week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.|||Score||Standard Error|Least Squares Mean
2644863|NCT01715298|Secondary|Change From Baseline in the Percentage of Days Without Rescue Medication Use|Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. The use of rescue medication is analyzed as the change from baseline in the percentage of days without usage of rescue medication over the 12 weeks treatment period. The baseline is calculated as the percentage of days without usage of rescue medication from during the the run-in epoch prior to randomization.|Baseline and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12|||percentage of days||Standard Error|Least Squares Mean
2644864|NCT01715298|Secondary|Change From Baseline in Mean Number of Puffs of Rescue Medication Per Day|Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. The use of rescue medication is analyzed as the change from baseline in the mean daily number of puffs used per patient over the 12 weeks treatment period. The baseline is calculated from the run-in epoch prior to randomization (mean number of puffs per day). A negative number indicates a reduction in the mean daily number of puffs of rescue medication.|Baseline and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12|||Number of puffs||Standard Error|Least Squares Mean
2644865|NCT01715298|Secondary|Breathlessness Assessed by Transition Dyspnea Index|Breathlessness at week 12 is measured using the interviewer-administered Transition Dyspnea Index (TDI). On day 1, breathlessness is assessed by the interviewer-administered Baseline Dyspnea Index (BDI). The change from BDI to TDI is assessed, with the TDI total score ranging from -9 to +9 units of the scale. The lower the score, the more deterioration in severity of dyspnea. Patients are considered to have clinically significant improvement (MCID) with the TDI score change versus BDI being equal to or greater than 1.|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12|||Score||Standard Error|Least Squares Mean
2644866|NCT01715298|Secondary|Change From Baseline in the Health Status Assessed by St. George's Respiratory Questionnaire|The health status, as reported by the patients, is assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ is a 50 item scale assessing symptoms, patient activities and impact of the disease. Scores range from 0 to 100 units, with higher scores indicating more limitations. The assessment is based on total score as well as the percentage of patients with clinically significant improvement at week 12 versus day 1. A clinically meaningful improvement (MCID) in SGRQ is defined as a decrease of 4 or more units of the SGRQ scale in the total score, as compared to baseline (change from baseline).|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12|||Score||Standard Error|Least Squares Mean
2644867|NCT01715298|Secondary|Mean Trough Forced Expiratory Volume in One Second|Mean trough Forced Expiratory Volume in one second (FEV1) is assessed as the arithmetic mean of two FEV1 measurements, conducted within the last hour of a 24 hour period from a morning dose, either that of day 1 or at week 12 of treatment. The data is reported as the change from baseline (CFB), with the baseline being the arithmetic mean of the two pre-dose measurements (-45 min and -15 min) preceding the serial lung function measurements on Day 1|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1and Week 12|||Liters||Standard Error|Least Squares Mean
2644927|NCT01714947|Primary|Tmax: Time of First Occurrence of Cmax for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution||Predose and multiple timepoints post-dose (up to 240 hours)|Pharmacokinetic (PK) Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||hr||Full Range|Median
2644868|NCT01715298|Secondary|Change From Baseline in Forced Expiratory Volume in One Second at All Individual Timepoints|The Forced Expiratory Volume in one second (FEV1) assessments for all individual time points of the serial measurements on day 1 and at week 12 are analyzed. Time points of the serial lung function measurements are 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose. The table indicates the percent change from baseline (CFB) in FEV1 and standard deviation in brackets. Where the FEV1 is lower than at baseline, a negative percent value can occur.|Day 1 and week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1and Week 12|||Percent||Standard Deviation|Mean
2644869|NCT01715298|Secondary|Change From Baseline in Standardized Area Under The Curve for Forced Expiratory Volume in One Second for Different Time Spans Post Dosing|"The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1FEV1) is assessed for different time spans (0-4 h, 4-8 h, 8-12 h) within the overall serial measurement post dosing (FEV1 AUCs Time Spans), at day 1 and at week 12 of treatment. Serial lung function measurements are taken at various the following time points post dosing on day 1 and at week 12 to calculate the FEV1 AUC for these different time spans: .5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose.~The endpoint was the change from baseline (CFB) in FEV1 AUC0-12h following the morning dose at day 1 or week 12, respectively, (defined as the mean FEV1 change from baseline over 5 min to 11 h 55 mins divided by 11 h 50 mins). Where the FEV1 AUC is smaller than at baseline, a negative value can occur."|Day 1 and Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1and Week 12|||Liters||Standard Error|Least Squares Mean
2644870|NCT01715298|Secondary|Change From Baseline in Standardized Area Under the Curve (AUC(0-12h)) for Forced Expiratory Volume in One Second Post Dosing|"The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) is assessed at day 1 of treatment. Serial lung function measurements are taken at the following various time points post dosing at day 1 to calculate the FEV1 AUC: 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose.~.The endpoint was the change from baseline (CFB) in FEV1 AUC0-12h following the morning dose at day 1 (defined as the mean FEV1 change from baseline over 5 min to 11 h 55 mins divided by 11 h 50 mins). Where the FEV1 AUC is smaller than at baseline, a negative value can occur."|Day 1|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1|||Liters||Standard Error|Least Squares Mean
2644871|NCT01715298|Primary|Change From Baseline in Standardized Area Under the Curve for Forced Expiratory Volume in One Second Post Dosing|"The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) is measured at week 12 of treatment. Serial lung function measurements are taken at the following time points following dosing at week 12 to calculate the FEV1 AUC: 5 min, 15 min, 1:00 h, 2:00 h, 4:00 h, 6:00 h, 8:00 h, and 11:55 h after the morning dose.~The primary endpoint was the change from baseline in FEV1 AUC0-12h following the morning dose at Week 12 (defined as the mean FEV1 change from baseline (CFB) over 5 min to 11 h 55 mins divided by 11 h 50 mins). Where the FEV1 AUC is smaller than at baseline, a negative value can occur"|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12|||Liters||Standard Error|Least Squares Mean
2644872|NCT01715285|Secondary|Time to Prostate-Specific Antigen (PSA) Progression|Time to PSA progression was defined as the time interval from the date of randomization to the date of PSA progression, according to PCWG2 criteria. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.|Upto 60 months|ITT analysis set included all participants randomized into the study.|||Months||95% Confidence Interval|Median
2644873|NCT01715285|Secondary|Time to Skeletal-Related Event|Time to skeletal-related event was defined as the earliest of the following: clinical or pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone.|Upto 44 months|ITT analysis set included all participants randomized into the study.|||months||95% Confidence Interval|Median
2644874|NCT01715285|Secondary|Time to Pain Progression|"Time to pain progression was defined as the time interval from randomization to the first date a participant experienced a greater than or equal to (>=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (>=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing no pain and 10 representing pain as bad as you can imagine."|Upto 60 months|ITT analysis set included all participants randomized into the study.|||Months||95% Confidence Interval|Median
2644875|NCT01715285|Secondary|Time to Subsequent Therapy for Prostate Cancer|Time to subsequent therapy was defined as the time interval from the date of randomization to the date of initiation of subsequent therapy for prostate cancer.|Upto 60 months|ITT analysis set included all participants randomized into the study.|||Months||95% Confidence Interval|Median
2644876|NCT01715285|Secondary|Time to Initiation of Chemotherapy|Time to initiation of chemotherapy was defined as the time interval from the date of randomization to the date of initiation of chemotherapy for prostate cancer.|Upto 65 months|ITT analysis set included all participants randomized into the study.|||months||95% Confidence Interval|Median
2644877|NCT01715285|Primary|Overall Survival (OS)|Overall survival was defined as the time from randomization to date of death from any cause.|Upto 60 months|ITT analysis set included all participants randomized into the study.|||months||95% Confidence Interval|Median
2645015|NCT01714336|Primary|Number of Participants Who Received a Hospitalization Transfusion|Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission|5 days||||participants|||Number
2644878|NCT01715285|Primary|Radiographic Progression-Free Survival (PFS)|Radiographic PFS was defined as the time interval from randomization to the first date of radiographic progression or death. Radiographic progression included progression by bone scan (according to modified Prostate Cancer Working Group 2 [PCWG2] criteria), defined as at least 2 new lesions on bone scan and progression of soft tissue lesions by computed tomography (CT) or magnetic resonance imaging (MRI) (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria). As per the RECIST 1.1 guideline, progression requires a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum as compared to nadir sum of diameter.|Up to 44 months|Intent-to-Treat (ITT) analysis set included all participants randomized into the study.|||Months||95% Confidence Interval|Median
2644879|NCT01715233|Secondary|Overall Survival|Number of participants alive at 2 years.|2 Years||||Participants|||Count of Participants
2644880|NCT01715233|Secondary|CHFR Methylation Status|Number of participants with advanced esophagogastric cancer that are CHFR-methylated or unmethylated at baseline.|Baseline|Only 18/21 participants had evaluable data for this outcome measure.|||Participants|||Count of Participants
2644881|NCT01715233|Primary|Response|Number of participants treated with mDCF with progressive disease (PD), stable disease (SD), partial response (PR), non-complete response and non-progressive disease (non-CR/non-PD), and partial response with progressive disease clinically (PR/PD) as defined by RECIST criteria. Response is compared based on CHFR-methylation status.|4 months|Response could not be assessed in 2/21 participants since imaging was not evaluable, therefore RECIST reads could not be obtained.|||Participants|||Count of Participants
2644882|NCT01715207|Secondary|Central Aortic PWV(Pulsed Wave Velocity)|Aortic PWV was measured according to the well-validated method using MRI 19. From the velocity-encoded MRIs, aortic contours were automatically detected and manually adjusted in each slice area throughout the cardiac cycle. The transit time between the flow curves of each region of the aorta was determined from the midpoint of the systolic up-slope on the flow versus time curve 26-28. The up-slopes were identified by drawing a line between the points of 40% and 60% maximum velocity on the waveform. The distance between each aortic level was measured on black blood images using a curved line along the center of the aorta. Based on these data, the regional PWV was calculated as the ratio of the distance between levels and the time differences between the arrival of the pulse wave at each level. The PWV was measured at two regions: the proximal aorta (proximal PWV between level 1 and level 2) and the entire aorta (PWV-total between level 1 and level 4).|6 months|MFS patients were recruited at Samsung Medical Center from November 2009 to October 2014. All patients were receiving atenolol as standard β-blocker therapy.|||m/s||Standard Deviation|Mean
2644883|NCT01715207|Primary|Central Aortic Distensibility by MRI|Analyses of the MRIs were performed using commercial software (Argus version 4.02, Siemens Medical Systems, Germany) by experienced observers who were blinded to patient information. To measure central aortic distensibility, the systolic and diastolic cross-sectional areas were measured by manual contouring of the aorta through the cardiac cycle on the cine image. Distensibility at the four regions was calculated as the mean of values obtained from the following equation: Distensibility = (Amax - Amin)/[Amin × (Pmax - Pmin)](10-3mm/Hg), where Amax is the maximal (systolic) aortic area, Amin is the minimal (diastolic) aortic area, Pmax is the systolic blood pressure (SBP), and Pmin is the diastolic blood pressure (DBP). Central aortic blood pressure measured non-invasively by SphygmoCor was used for systolic and diastolic blood pressure.|6 months|MFS patients were recruited at Samsung Medical Center from November 2009 to October 2014. All patients were receiving atenolol as standard β-blocker therapy.|||(mmHg ^ -1) x 10 ^ -3||Standard Deviation|Mean
2644884|NCT01715129|Secondary|Cmin of Triptorelin in Subset of 18 Subjects||At Day 92 and 183|Day 92: Four subjects (presenting particularly high levels of triptorelin) were excluded from 18-subject subset.|||ng/mL||Standard Deviation|Mean
2644885|NCT01715129|Secondary|Area Under the Concentration Versus Time Curve Between 0 and 24 Hours (AUC0-24) of Triptorelin||At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1|PK profile was assessed in a subset of 18 subjects.|||h*ng/mL||Standard Deviation|Mean
2644886|NCT01715129|Secondary|Peak Plasma Concentration Value (Cmax) of Triptorelin||At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1|PK profile was assessed in a subset of 18 subjects.|||ng/mL||Standard Deviation|Mean
2644887|NCT01715129|Secondary|Time to Cmax (Tmax) of Triptorelin||At 1, 2, 3, 4, 5, 6, 7, 8 and 24 hours after first dose on Day 1|Pharmacokinetic (PK) profile was assessed in a subset of 18 subjects.|||Hours||Full Range|Median
2644888|NCT01715129|Secondary|Percentage of Subjects With Adverse Events||Up to Day 183|All subjects who received at least one dose of study treatment were included in safety population.|||Percentage of subjects|||Number
2644889|NCT01715129|Secondary|Clinically Apparent Tumor Progression|Tumour progression was recorded according to the Investigator's clinical judgement, considering the PSA levels and any other indications of disease; the clinical confirmation might be supplemented by radiological or other investigations or scans if required. The lack of clinically apparent tumour progression was assessed at Day 92 (prior to administration of the second dose) and Day 183 (end of study visit).|Day 92 and 183|ITT population|||participants|||Number
2644890|NCT01715129|Secondary|Percentage of Subjects With Normal and Abnormal PSA Levels at Day 183 (End of Study Visit)|"0-4 ng/mL (normal PSA value)~>4 ng/mL (abnormal PSA levels)"|At Day 183|Subjects completed Day 183 visit (End of Study)|||Percentage of subjects|||Number
2644891|NCT01715129|Secondary|Percentage Change in Prostate Specific Antigen (PSA) Levels From Baseline in All Subjects|Serum PSA level was presented throughout the study using descriptive statistics displaying raw values, change from Baseline and percentage change from Baseline at each visit in all subjects from the ITT population only. Additionally, the PSA level was described in subjects with elevated PSA levels (i.e. >4 ng/mL) at study entry, and the proportion of subjects with normal PSA levels (i.e. [0-4] ng/mL) at Day 183 compared to Baseline was presented.|From Day 1 (Baseline) to Day 183 (End of study)|ITT population at End of Study (Day 183). One subject had no data.|||Percentage Change||Standard Deviation|Mean
2644892|NCT01715129|Secondary|Plasma Triptorelin Levels (Cmin)|Minimal triptorelin plasma concentration at the end of each dosage interval just before the next dose injection (Cmin) for Days 92 and 183 were assessed.|At Day 92 and 183|ITT population. No samples were collected from 4 subjects at Day 92 and 9 subjects at Day 183|||ng/mL||Standard Deviation|Mean
2644894|NCT01715129|Secondary|Percentage of Subjects Demonstrating Castration With Testosterone Level <50 ng/dL at Day 95|Percentage of subjects demonstrating castration at Day 95 (3-4 days after administration of the second dose to assess the suppression of acute-on-chronic effect following the second administration) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.|Day 95|IC1 population.|||Percentage of subjects||95% Confidence Interval|Number
2644895|NCT01715129|Secondary|Probability of Testosterone <50 ng/dL|"Probability of testosterone <50 ng/dL from Day 29 to Day 183 was assessed as a secondary endpoint using the time to event from first administration date to first observed (and subsequently confirmed if assessment not performed at end of study or early withdrawal visits) serum testosterone level ≥50 ng/dL or ≥1.735 nmol/L at or after Day 29, assessed using the LC-MS/MS Method and Missing Data imputed by immunoassay method Kaplan-Meier Analysis.~LC-MS/MS: Liquid Chromatography-Tandem Mass Spectrometry"|Day 29 through Day 183|Intention-to-treat (ITT) population: All treated subjects|||Proportion of subjects||95% Confidence Interval|Number
2644896|NCT01715129|Secondary|Percentage of Subjects Demonstrating Castration Before Administration of the Second Dose|Percentage of subjects demonstrating castration at Day 92 (before administration of the second dose) were also assessed using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and summarised using descriptive statistics on the ITT and IC populations.|At Day 92|Initially Castrated (IC1) population: All treated subjects with testosterone levels <50 ng/dL at Day 29 or at Day 36, assessed with the LC-MS/MS method and missing data imputed by immunoassay method.|||Percentage of subjects||95% Confidence Interval|Number
2644897|NCT01715129|Primary|Percentage of Subjects Demonstrating Castration at Day 29 and Maintaining Castration at Day 183|Percentage of subjects castrated (i.e. with serum testosterone <50 ng/dL or 1.735 nmol/L, using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and the proportion with castration maintained at Day 183 (after receiving 2 S.C. administrations of triptorelin pamoate, three months apart); they were calculated along with their respective 95% confidence intervals (CI) using exact methods on the ITT population at Day 29 and on the initially castrated (IC) population at Day 183|At Day 29 and 183|N=Number of subjects attending the visit|||Percentage of subjects||95% Confidence Interval|Number
2644898|NCT01715064|Secondary|Exercise-Induced Feelings Inventory - Questionnaire (EIFI)|Correlations will be assessed between cortical silent period and exercise-induced feelings.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').|||||||
2644899|NCT01715064|Secondary|Hospital Anxiety and Depression Scale - Questionnaire(HADS)|Correlations will be assessed between cortical silent period and acute anxiety and depression.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').|||||||
2644900|NCT01715064|Secondary|State-Trait Anxiety Inventory - Questionnaire(STAI)|Correlations will be assessed between cortical silent period and acute anxiety.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').|||||||
2644901|NCT01715064|Secondary|Profile of Mood States Questionnaire(PoMS)|Correlations will be assessed between cortical silent period and acute mood state.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').|||||||
2644902|NCT01715064|Primary|Change From Baseline in Cortical Silent Period (CSP) Will be Determined Using Transcranial Magnetic Stimulation (TMS) of the Motor Cortex.|CSP is a measure of cortical inhibition that is negatively related to anxiety, stress, and depression.|10-15 minutes prior to the control/exercise condition ('pre-test') and 10-15 minutes after the control/exercise condition ('post-test').||||seconds||Standard Deviation|Mean
2644903|NCT01714947|Secondary|Number of Participants With Clinically Significant Changes or Abnormalities in Vital Sign Measurements|Vital signs included body temperature, heart rate, and sitting blood pressure. The investigator determined if the changes were clinically significant.|Part A: Day 1 and EOS (Day 31 if not continuing to Part B), Part B: Day 1 of each cycle and EOS (Up to 117 days)|Safety population included all participants who received at least 1 dose of study drug.|||Participants|||Number
2644904|NCT01714947|Secondary|Number of Participants With Clinically Significant Changes or Abnormalities in Clinical Laboratory Values Reported as AEs|An abnormal laboratory was assessed to be an AE if the value lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from Baseline.|Part A: Day 1 and End of Study (EOS) Day 31 if not continuing to Part B, Part B: Days 8 and 15 of each cycle and EOS (Up to 117 days)|Safety Population included all participants who received at least 1 dose of study drug.|||Participants|||Number
2644905|NCT01714947|Secondary|Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events|An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) was defined as any AE at any dose that: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant disability/incapacity or resulted in congenital anomaly/birth defect. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.|From first dose of study drug through 30 days after the last dose of study drug (Up to 117 days)|Safety Population included all participants who received at least 1 dose of study drug.|||Participants|||Number
2644906|NCT01714947|Secondary|Percentage of Alisertib Metabolites in Feces Following a Single Dose of [^14C]-Alisertib Oral Solution|Total radioactive peak distributions of metabolites in 0 to 192 hours pooled fecal samples from participants.|Predose and multiple timepoints post-dose (0 to 192 hours)|PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||percent of dose|||Number
2645016|NCT01714323|Other Pre-specified|All-cause Mortality|Death from any cause in the 6 months after hospital discharge|6 months||||Participants|||Count of Participants
2645017|NCT01714323|Other Pre-specified|All-cause Hospitalizations|Self-reported admission to a hospital in the 12 months after the index hospitalization.|12 months||||hospital admissions|||Number
2644908|NCT01714947|Secondary|Percentage of Alisertib Metabolites in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution|Total radioactive peak distributions of metabolites in 0 to 192 hours pooled plasma samples from participants.|Predose and multiple timepoints post-dose (0 to 192 hours)|PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||percent of plasma AUC0-192hr|||Number
2644909|NCT01714947|Primary|Renal Clearance (CLR) of Alisertib||Predose and multiple timepoints post-dose (up to 240 hours)|Participants from the PK Population, all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance, with data for CLR.|||L/hr||Standard Deviation|Mean
2644910|NCT01714947|Primary|Ae: Amount of Alisertib Excretion in Urine||Predose and multiple timepoints post-dose (up to 240 hours)|Participants from the PK Population, all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance, with data available for Ae.|||ng||Standard Deviation|Mean
2644911|NCT01714947|Primary|Fe: Fraction of Administered Dose of Alisertib Excreted in Urine||Predose and multiple timepoints post-dose (up to 240 hours)|Participant from the PK Population, all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance, with data available for Fe.|||percent of dose||Standard Deviation|Mean
2644912|NCT01714947|Primary|Percent of Total Radioactivity (TRA) in Urine and Feces||Predose and multiple timepoints post-dose (up to 240 hours)|PK population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||percent of TRA||Standard Deviation|Mean
2644913|NCT01714947|Primary|Ae: Amount of [^14C]-Alisertib Excreted in Feces||Predose and multiple timepoints post-dose (up to 240 hours)|PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||ng(eq)||Standard Deviation|Mean
2644914|NCT01714947|Primary|Ae: Amount of [^14C]-Alisertib Excreted in Urine||Predose and multiple timepoints post-dose (up to 240 hours)|PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||nanogram equivalent [ng(eq)]||Standard Deviation|Mean
2644915|NCT01714947|Primary|Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Feces||Predose and multiple timepoints post-dose (up to 240 hours)|PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||percent of dose||Standard Deviation|Mean
2644916|NCT01714947|Primary|Fe: Fraction of Administered Dose of [^14C]-Alisertib Excreted in Urine||Predose and multiple timepoints post-dose (up to 240 hours)|PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||percent of dose||Standard Deviation|Mean
2644917|NCT01714947|Primary|Ratio of Alisertib Plasma AUC∞ to Drug-Related Material TRA Plasma AUC∞||Predose and multiple timepoints post-dose (up to 240 hours)|PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||ratio||Standard Deviation|Mean
2644918|NCT01714947|Primary|Ratio of Whole Blood TRA AUC∞ to Plasma TRA AUC∞||Predose and multiple timepoints post-dose (up to 240 hours)|PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||ratio||Standard Deviation|Mean
2644919|NCT01714947|Primary|Ratio of Alisertib Plasma AUClast to Drug-Related Material TRA Plasma AUClast||Predose and multiple timepoints post-dose (up to 240 hours)|PK population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||ratio||Standard Deviation|Mean
2644920|NCT01714947|Primary|Ratio of Whole Blood TRA AUClast to Plasma TRA AUClast||Predose and multiple timepoints post-dose (up to 240 hours)|PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||ratio||Standard Deviation|Mean
2644921|NCT01714947|Primary|Ratio of Alisertib Plasma Cmax to Drug-Related Material TRA Plasma Cmax||Predose and multiple timepoints post-dose (up to 240 hours)|PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||ratio||Standard Deviation|Mean
2644922|NCT01714947|Primary|Ratio of Whole Blood Total Radioactivity (TRA) Cmax to Plasma TRA Cmax||Predose and multiple timepoints post-dose (up to 240 hours)|PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||ratio||Standard Deviation|Mean
2644923|NCT01714947|Primary|CL/F: Apparent Clearance After Extravascular Administration, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib Following a Single Dose of [^14C]-Alisertib Oral Solution||Predose and multiple timepoints post-dose (up to 240 hours)|PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2644924|NCT01714947|Primary|T1/2: Terminal Half Life for Alisertib and Drug-Related Material in Plasma Following a Single Dose of [^14C]-Alisertib Oral Solution||Predose and multiple timepoints post-dose (up to 240 hours)|PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||hour||Standard Deviation|Mean
2644925|NCT01714947|Primary|AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution||Predose and multiple timepoints post-dose (up to 240 hours)|PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||hr*nmol/L||Standard Deviation|Mean
2644926|NCT01714947|Primary|AUClast: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution||Predose and multiple timepoints post-dose (up to 240 hours)|PK Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||hour (hr)*nmol/L||Standard Deviation|Mean
2644928|NCT01714947|Primary|Cmax: Maximum Observed Plasma Concentration for Alisertib and Drug-Related Material Following a Single Dose of [^14C]-Alisertib Oral Solution||Predose and multiple timepoints post-dose (up to 240 hours)|Pharmacokinetic (PK) Population included all participants with sufficient dosing and PK concentration-time data to reliably estimate PK parameters and mass balance.|||nanomole (nmol)/liter (L)||Standard Deviation|Mean
2644929|NCT01714921|Secondary|Analysis of the Positive Predictive Value of the Investigated ICD Oversensing Algorithms|Endpoint: Episode classified by the device as T-wave Oversensing or 'Noise'.|through study completion|In total, 71 episodes were detected by the device and classified as T-wave Oversensing or Noise, but only 20 had electrogram (EGM) strips available. The analysis of the positive predictive value (PPV) was performed on these 20 episodes only. The number of true positives was 20. The number of false positives was 0.|||Positive Predictive Value in %|episodes with EGM strips||Number
2644930|NCT01714921|Secondary|Analysis of the Proportion of Patients in Which ICD Parameters Remain on Nominal Programming.|"Endpoint: Deviation of ICD parameter programming in comparison to nominal programming at the first Follow-Up ≥ 90 days post-implant.~Nominals for dual chamber ICD or cardiac resynchronization therapy (CRT) devices:~Lead Noise Discrimination = 'OnWithTimeout'~Lead Failure Predictor = 'On'~PR-Logic: AfibAflutter Rejection Rule = 'On'~PR-Logic: Sinus Tach Rejection Rule = 'On'~PR-Logic: Other 1:1 Rejection Rule = 'On'~High Rate Timeout = 'Off'~VF High Rate Timeout = 'Off'~Wavelet Rejection Rule = 'On'~VF Detection Interval = 320 and SVT Minimum Cycle Length = 260~T-Wave Oversensing Discrimination = 'On'~ATP During Charging = 'DuringCharging'~Nominals for single chamber ICDs:~Lead Noise Discrimination = 'OnWithTimeout'~Lead Failure Predictor = 'On'~High Rate Timeout = 'Off'~VF High Rate Timeout = '0.75 min'~Wavelet Rejection Rule = 'On'~VF Detection Interval = 320 and SVT Minimum Cycle Length = 260~T-Wave Oversensing D"|At the first Follow-Up ≥ 90 days post-implant||||Participants|||Count of Participants
2644931|NCT01714921|Secondary|Number of Patients That Developed AT/AF|Endpoint: patients with >5 min atrial tachycardia/atrial fibrillation (AT/AF) in 'Daily Log' (Cardiac Compass)|24 months|Out of all patients analyzed (N=504), the patients with Single-Chamber-ICDs were excluded as these devices had no feature to identify AT/AF. This lead to N=367. Out of these 367 patients only 337 had Follow-Up data available whereas 30 patients only had implant data.|||Participants|||Count of Participants
2644932|NCT01714921|Secondary|Analysis of the Number of Patients With Primary Preventive Indication for an ICD That Develop VF Episodes.|Endpoint: Number of primary prevention patients with at least one ventricular fibrillation (VF) episode detected and successfully treated by the ICD|24 months|Of all 272 patients with primary preventive indication, only 265 patients had device data available for the Follow-Up period.|||Participants|||Count of Participants
2644933|NCT01714921|Secondary|Percentage of Patients, Without Shock Delivery Due to Smart Shock Technology|Endpoint: Patients without shock delivery due to Smart Shock technology|24 months||||pat. w. at least 1 shock prevented in %|||Number
2644934|NCT01714921|Secondary|Number of Patients With All Smart Shock Algorithms Are Programmed on|"Endpoint: Patients, in which none of the Smart Shock algorithms is programmed OFF during the first Follow-Up after a maximum length of 90 days and 180 days."|90 days or 180 days|Patients with data available at 90 days|||Participants|||Count of Participants
2644935|NCT01714921|Primary|Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology.|"Smart Shock technology is a suite of algorithms that are designed to prevent inappropriate shocks in ICD&CRT patients.~Endpoints for the primary objective:~Episodes with shock therapy~Episodes without shock delivery due to Smart Shock™ technology~Episodes classified as supraventricular tachycardia (SVT) by PR Logic~Episodes classified as SVT by Wavelet~Shock therapy suppressed by T-wave Discrimination~Shock therapy suppressed by Lead Noise Discrimination~Shock therapy suppressed by Confirmation +~Episode with successful anti-tachycardia pacing (ATP) During Charging"|24 months|"The change of episodes of episodes inappropriately treated by shock due to Smart Shock™ was calculated as follow:~change of episodes= (Episodes without shock therapy due to Smart Shock™)/(total number of episodes)"|||% of episodes wo shock due to SmartShock|total number of episodes||Number
2644936|NCT01714817|Secondary|Number of Participants With Other Marked Chemistry Laboratory Abnormalities During the Double Blind Period|LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value CALCIUM, TOTAL mmol/L 5.2 CA <0.8X LLN OR >1.2X ULN, OR IF PRE RX<LLN THEN USE <0.75X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.25X PRE RX OR <LLN PHOSPHORUS, INORGANIC mmol/L 5.2 PHOS <0.75X LLN OR >1.25X ULN, OR IF PRE RX<LLN THEN USE <0.67X PRE RX OR >ULN GLUCOSE, SERUM mmol/L 4.1 GLUC <65 mg/dL, OR >220 mg/dL PROTEIN, TOTAL g/L 5.0 TPRO <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE 0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE 1.1X PRE RX OR <LLN ALBUMIN g/L 3.0 ALB <0.9X LLN, OR IF PRE RX<LLN THEN USE <0.75X PRE RX CHOLESTEROL, TOTAL (TC) mmol/L 5.2 CHOL >2X PRE R|Day 729||2019-05-31|05/2019||||
2644937|NCT01714817|Secondary|Number of Participants With Marked Urinalysis Laboratory Abnormalities During the Double Blind Period|LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value PROTEIN, URINE Unknown UPRO IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 GLUCOSE, URINE N/A UGLU IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 BLOOD, URINE N/A UBLD IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 RBC, URINE hpf 5.0 URBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4 WBC, URINE hpf 5.0 UWBC IF MISSING PRE THEN USE >=2, OR IF VALUE >=4, OR IF PRE RX =0 OR 0.5 THEN USE >=2, OR IF PRE RX =1 THEN USE >=3, OR IF PRE RX =2 OR 3 THEN USE >=4|Day 729||2019-05-31|05/2019||||
2644938|NCT01714817|Secondary|Number of Participants With Marked Electrolyte Laboratory Abnormalities During the Double Blind Period|LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value SODIUM, SERUM mmol/L 4.0 NA <0.95X LLN OR >1.05X ULN, OR IF PRE RX<LLN THEN USE <0.95X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.05X PRE RX OR <LLN POTASSIUM, SERUM mmol/L 4.1 K <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE <0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR <LLN CHLORIDE, SERUM mmol/L 5.0 CL <0.9X LLN OR >1.1X ULN, OR IF PRE RX<LLN THEN USE <0.9X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.1X PRE RX OR <LLN|Day 729||2019-05-31|05/2019||||
2646232|NCT01705080|Secondary|Mean Change in Ambulatory Systolic Blood Pressure at 48 Months||Baseline and 48 months|Data were not collected for participants in Group C and Unassigned Group at 48 months.|||mmHg||Standard Deviation|Mean
2644939|NCT01714817|Secondary|Number of Participants With Marked Liver and Kidney Function Laboratory Abnormalities During the Double Blind Period|LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value ALKALINE PHOSPHATASE (ALP) U/L 5.0 ALP >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX ASPARTATE AMINOTRANSFERASE (AST) U/L 5.0 AST >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX ALANINE AMINOTRANSFERASE (ALT) U/L 5.0 ALT >3X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX G-GLUTAMYL TRANSFERASE (GGT) U/L 5.0 GGT >2X ULN, OR IF PRE RX>ULN THEN USE >3X PRE RX BILIRUBIN, TOTAL umol/L 5.1 TBILI >2X ULN, OR IF PRE RX>ULN THEN USE >4X PRE RX BILIRUBIN, DIRECT umol/L 5.1 DBILI >1.5X ULN, OR IF PRE RX>ULN THEN USE >2X PRE RX BLOOD UREA NITROGEN mmol/L 5.1 BUN >2X PRE RX CREATININE umol/L 5.0 CREAT >1.5X PRE RX|Day 729||2019-05-31|05/2019||||
2644940|NCT01714817|Secondary|Number of Participants With Marked Hematology Laboratory Abnormalities During the Double Blind Period|LLN= Lower limit of normals ULN= Upper limit of normals Pre RX = Baseline value HEMOGLOBIN g/L 4.0 HB >3 G/DL DECREASE FROM PRE RX HEMATOCRIT vol 6.3 HCT <0.75X PRE RX ERYTHROCYTES x10*12 c/L 5.2 RBC <0.75X PRE RX PLATELET COUNT x10*9 c/L 5.0 PLAT <0.67X LLN OR >1.5X ULN, OR IF PRE RX<LLN THEN USE 0.5X PRE RX AND <100,000/MM3 LEUKOCYTES x10*9 c/L 6.2 WBC <0.75X LLN OR >1.25X ULN, OR IF PRE RX<LLN THEN USE <0.8X PRE RX OR >ULN, OR IF PRE RX>ULN THEN USE >1.2X PRE RX OR <LLN EOSINOPHILS (ABSOLUTE) x10*9 c/L 8.3 EOSA IF VALUE > .750 X10*3 c/uL BASOPHILS (ABSOLUTE) x10*9 c/L 8.3 BASOA IF VALUE > 400/MM3 MONOCYTES (ABSOLUTE) x10*9 c/L 8.3 MONOA IF VALUE > 2000/MM3 LYMPHOCYTES (ABSOLUTE) x10*9 c/L 8.3 LYMPA IF VALUE < .750 X10*3 c/uL OR IF VALUE > 7.50 X10*3 c/uL|Day 729||2019-05-31|05/2019||||
2644941|NCT01714817|Secondary|Mean Change From Baseline in Laboratory Analytes During the Double-blind Period|Laboratory assessments were analyzed centrally, with the exception of pregnancy testing. Blood draws and urine collections were performed at visits specified in the protocol.|Day 1 to Day 729||2019-05-31|05/2019||||
2644942|NCT01714817|Secondary|Summary Statistics for Heart Rate|Summary statistics for Heart Rate|Day 1 to Day 729||2019-05-31|05/2019||||
2644943|NCT01714817|Secondary|Summary Statistics for Diastolic Blood Pressure|Summary statistics for diastolic blood pressure|Day 1 to Day 729||2019-05-31|05/2019||||
2644944|NCT01714817|Secondary|Summary Statistics for Systolic Blood Pressure|Summary statistics for systolic blood pressure|Day 1 to Day 729||2019-05-31|05/2019||||
2644945|NCT01714817|Secondary|AUC (TAU): Area Under the Serum Concentration Time Curve Over a Dosing Interval|AUC (TAU): Area under the serum concentration time curve over a dosing interval between Days 337 to 365.|Days 337 to 365|As per the study protocol, this Outcome Measure was only planned to be analyzed upon the successful completion of the Primary Endpoint. Since the study failed to meet the primary endpoint, this Outcome was not analyzed.||||||
2644946|NCT01714817|Secondary|Cmax: Maximum Observed Serum Concentration Following Subjects Receiving Active Abatacept IV|Cmax: Maximum observed serum concentration following subjects receiving active abatacept IV|at 1 hour post Day 1 dose and 30 minutes post Day 337 dose|As per the study protocol, this Outcome Measure was only planned to be analyzed upon the successful completion of the Primary Endpoint. Since the study failed to meet the primary endpoint, this Outcome was not analyzed||||||
2644947|NCT01714817|Secondary|Cmin (ug/mL): Trough Level Serum Concentration of Abatacept Prior to the Administration of the IV Infusion|Trough level serum concentration of abatacept prior to the administration of the IV infusion on Days 1 to 365|Days 1 to 365|As per the study protocol, this Outcome Measure was only planned to be analyzed upon the successful completion of the Primary Endpoint. Since the study failed to meet the primary endpoint, this Outcome was not analyzed.||||||
2644948|NCT01714817|Secondary|Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During the Double-blind Period|"BILAG index measures and reports disease activity in different organs/systems separately. The BILAG score is calculated for each of nine systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. A BILAG A represents the presence of one or more serious features of lupus. A BILAG B represents more moderate features of the disease. A BILAG C includes only mild symptomatic features. A BILAG D represents only prior activity with no current symptoms due to active lupus. A BILAG E represents an organ that has never been involved."|Day 1 to Day 729||2019-05-31|05/2019||||
2644949|NCT01714817|Secondary|Number of Participants With Sustained Change From Higher Level of Response to no Response During the Double-blind Period|Sustained change to no response is defined as going from CR (or PR) to NR and remaining in NR for at least 2 consecutive visits; visits should be approximately 4 weeks apart. This analysis will be based on time from response CR (or PR) to the first visit in which the no response (NR) was achieved and sustained to the next visit.|Day 729||2019-05-31|05/2019||||
2644950|NCT01714817|Secondary|Time to First Sustained Change to No Response During the Double-blind Period|Sustained response defined as response present at 2 consecutive visits approximately 4 weeks apart. No renal response (NR): defined as not meeting criteria for CR or PR or withdrawn|Day 729||2019-05-31|05/2019||||
2644951|NCT01714817|Secondary|Adjusted Mean Change From Baseline in eGFR Over Time|Estimated glomerular filtration rate(eGFR), will be calculated by the CKD-EPI formula shown below.50 eGFR is expressed as mL/min per 1.73m2. For the purpose of this study lower limit of normal eGFR is defined as 90mL/min per 1.73m2 eGFR = 141 X min (Scr/k, 1)α X max (Scr/k, 1)-1.209 X 0.993Age X (1.018 [if female]) X (1.159 [if black]) Where Scr is serum creatinine (mg/dL), k is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and max indicates the maximum of Scr/k or 1, age in years.|Day 729||2019-05-31|05/2019||||
2644952|NCT01714817|Secondary|Median Percent Change From Baseline in UPCR Over Time|A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used.|Day 729||2019-05-31|05/2019||||
2644953|NCT01714817|Secondary|Adjusted Mean Change From Baseline in UPCR Over Time|A repeated measure mixed model that included the baseline UPCR value, randomization stratification factors, time, and time by treatment interaction as fixed effects and subject as a random effect was used.|Day 729||2019-05-31|05/2019||||
2645018|NCT01714323|Secondary|Use of Smoking Cessation Treatment After Hospital Discharge|Use of either FDA-approved pharmacotherapy for tobacco dependence (nicotine replacement therapy, bupropion, or varenicline), or psychosocial support (including telephone counseling, in person counseling, web-based counseling, physician counseling).|1 month, 3 months, 6 months||||Participants|||Count of Participants
2646233|NCT01705080|Secondary|Mean Change in Ambulatory Systolic Blood Pressure at 36 Months||Baseline and 36 months||||mmHg||Standard Deviation|Mean
2644954|NCT01714817|Secondary|Median Time to Partial Response (PR) During the Double-blind Period in Nephrotic Participants|The estimate of median time to Partial Response (PR) in nephrotic participants is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Subject does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR < 0.5 OR 50% reduced from baseline and < 1 if baseline value was < 3, OR 50% reduced from baseline and < 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment|Day 729||2019-05-31|05/2019||||
2644955|NCT01714817|Secondary|Median Time to Partial Response (PR) During the Double-blind Period in All Participants|The estimate of median time to Partial Response (PR) is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Subject does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR < 0.5 OR 50% reduced from baseline and < 1 if baseline value was < 3, OR 50% reduced from baseline and < 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment|Day 729||2019-05-31|05/2019||||
2644956|NCT01714817|Secondary|Median Time to Complete Response (CR) During the Double-blind Period in Nephrotic Participants|The estimate of median time to Complete Response (CR) in nephrotic participants is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) < 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment.|Day 729||2019-05-31|05/2019||||
2644957|NCT01714817|Secondary|Median Time to Complete Response (CR) During the Double-blind Period in All Participants|The estimate of median time to Complete Response (CR) is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) < 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment.|Day 729||2019-05-31|05/2019||||
2644958|NCT01714817|Secondary|Number of Participants With Ranked Outcome of CR, PR, and No Response Throughout the Double-blind Period|Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) < 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment. Partial renal response (PR): defined as meeting ALL of the following criteria: Subject does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR < 0.5 OR 50% reduced from baseline and < 1 if baseline value was < 3, OR 50% reduced from baseline and < 3 if baseline value was greater than or equal to 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment No renal response (NR): defined as not meeting criteria for CR or PR or withdrawn|Day 729||2019-05-31|05/2019||||
2644959|NCT01714817|Secondary|Number of Participants With Any Adverse Events (AEs)|All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 19.1). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug.|From Day 1 up to 56 days post last dose in Year 1 of the double-blind period|All treated participants|||Participants|||Number
2644960|NCT01714817|Secondary|Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During Year 1 of the Double-blind Period|"Adjusted mean change from baseline in British Isles Lupus Assessment Group (BILAG) score over time during Year 1 of the double-blind period based on a repeated measure mixed model and presented at each visit in the first 12-month of the double-blind period. BILAG index measures disease activity in different organs/systems separately. BILAG score is calculated for each of 9 systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. BILAG A represents the presence of serious features of lupus. BILAG B represents more moderate features of the disease. BILAG C includes only mild symptomatic features. BILAG D represents prior activity with no current symptoms due to active lupus. BILAG E represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome."|Day 1 to Day 365|All randomized and treated participants|||BILAG score||95% Confidence Interval|Mean
2644961|NCT01714817|Secondary|Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Overall Population|Adjusted Mean Change from Baseline in Urine protein/creatinine ratio (UPCR) at Day 365 of the double-blind period in the overall population|Day 1 and Day 365|All Randomized and Treated Participants with both post-baseline and baseline measurements|||UPCR (mg/mg)||Standard Error|Mean
2644962|NCT01714817|Secondary|Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Nephrotic Participants|Adjusted Mean Change from Baseline in Urine protein/creatinine ratio (UPCR) at Day 365 of the double-blind period in nephrotic participants|Baseline and Day 365|All Randomized and Treated Nephrotic participants with both post-baseline and baseline measurements|||UPCR (mg/mg)||Standard Error|Mean
2644963|NCT01714817|Secondary|Percentage of Nephrotic Participants in CR of Lupus Glomerulonephritis at Day 365 of the Double-blind Period|Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. Nephrotic is defined as screening UPCR >=3.0 mg/mg (>=339mg/mmol). CR is defined the following criteria: eGFR is normal or no <85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equivalent for at least 28 days prior. Subjects with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable.|365 days|All randomized and treated nephrotic participants. Nephrotic is defined as screening UPCR >= 3.0mg/mg (>=339mg/mmol)|||Percentage|||Number
2644964|NCT01714817|Primary|Percentage of Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 365 of the Double-blind Period|Number of participants achieving CR was divided by the total number of participants in that arm and expressed as a percentage. Complete Response (CR) defined as: eGFR is normal or no <85% of the baseline; eGFR based on mean creatinine value from day 358 and 365. Proteinuria: UPCR<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no >10 mg prednisone or equiv. for at least 28 days prior to assessment. Participants with >10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as having achieved CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use (Yes/No), race (Asian/ Black/Caucasian/Other) and baseline UPCR as a continuous variable.|365 days|All randomized and treated participants|||Percentage|||Number
2644965|NCT01714804|Secondary|Oswestry Disability Index (ODI), Visual Analog Scale (VAS) for Pain in the Back (VAS-back) and in the Leg (VAS-leg)||12 months|Data were not collected||||||
2644966|NCT01714804|Primary|Number of Levels With Posterolateral Fusion|Assessment of fusion in the posterolateral space was performed using by X-ray and/or CT. Assessment was performed by the operating surgeon blinded towards patient. Each spinal level was graded separately|12 months|One level is defined as a spinal segment in the lumbar spine.|||levels|levels||Count of Units
2644967|NCT01714726|Secondary|Number of Participants With ADA Positive to MEDI2070 in Open-label Period|The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point.|Up to 28 week post last dose (approximately 140 weeks)|Value of 0 represents the double-blind portion of the trial|||Participants|||Count of Participants
2644968|NCT01714726|Secondary|Number of Participants With Positive Anti-drug Antibody (ADA) to MEDI2070 in Double-blind Period|The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point.|Baseline (Week0/Day 1) up to 28 week post last dose (approximately 40 weeks)|Value of 0 represents the open-label portion of the trial|||Participants|||Count of Participants
2644969|NCT01714726|Secondary|Maximum Mean Serum Concentration of MEDI2070 in Open-label Period|The PK population included all subjects who received at least one dose of MEDI2070 (either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for pre-dose Week 12 time frame and is reported by an arbitrary value (NA).|Pre-dose on Weeks 12, 24, and 112|Serum MEDI2070 concentration data was summarized descriptively by visit. Value of 0 represents the double-blind portion of the trial.|||mcg/ML||Standard Deviation|Mean
2644970|NCT01714726|Secondary|Maximum Mean Serum Concentration of MEDI2070 in Doubleblind Period|Pharmacokinetic (PK) population included all subjects who received at least one dose of MEDI2070(either in double-blind period or in open-label period) and had at least one PK sample that was above the lower limit of quantification was considered for this end point. Serum concentration of MEDI2070 for subject in 'Placebo' arm is not applicable for this time frames and is reported by an arbitrary value (NA).|Post-dose on Week 0 (Day 1); pre and post-dose on Week 4; pre-dose on Week 8|Serum MEDI2070 concentration data was summarized descriptively by visit. Value of 0 represents the open-label portion of the trial.|||mcg/ML||Standard Deviation|Mean
2644971|NCT01714726|Secondary|Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Open-label Period|The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment(approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.|From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)|Value of 0 represents the double-blind portion of the trial|||Participants|||Count of Participants
2644972|NCT01714726|Secondary|Number of Participants With Vital Signs Abnormalities Reported as TEAEs in Double-blind Period|The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1)to 36 weeks post treatment(approximately 48 weeks). Subjects in the safety population were analysed for this end point.|From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)|Value of 0 represents the open-label portion of the trial|||Participants|||Count of Participants
2644973|NCT01714726|Secondary|Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs in Open-label Period|The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1)to 36 weeks post treatment (up toapproximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.|From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)|Value of 0 represents the double-blind portion of the trial|||Participants|||Count of Participants
2644974|NCT01714726|Secondary|Number of Participants With Clinical Laboratory Abnormalities as TEAEs in Double-blind Period|The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (up to approximately 48 weeks). Subjects in the safety population were analysed for this end point.|From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)|Value of 0 represents the open-label portion of the trial|||Participants|||Count of Participants
2645019|NCT01714323|Secondary|Duration of Tobacco Abstinence After Hospital Discharge|Self-reported number of days in which a participant was abstinent from tobacco after hospital discharge, by self-report, obtained from surveys done at 1 month, 3 months, and 6 months. Patient can only relapse once but it can occur at any point up to 6 months after discharge. Therefore, the data point can come from either the 1 or 3 or 6 month follow-up depending on when relapse occurred.|1 month, 3 months, 6 months||||days||Inter-Quartile Range|Median
2644975|NCT01714726|Secondary|Number of Participants With TESAEs in Open-label Period|An AE is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A SAE is any AE that resulted in death,inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.|From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)|Value of 0 represents the double-blind portion of the trial|||Participants|||Count of Participants
2644976|NCT01714726|Secondary|Number of Participants With TEAEs in Open-label Period|An AE is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A SAE is any AE that resulted in death,inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 148 weeks). Open-label population was analysed for this endpoint, which included all subjects who were enrolled in the 100-week, open-label treatment period and have at least one dose of open-label MEDI2070 210 mg SC treatment.|From first open-label dose administration (Week 12) to 36 weeks post last dose (up to 148 weeks)|Value of 0 represents the double-blind portion of the trial|||Participants|||Count of Participants
2644977|NCT01714726|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) in Double-blind Period|An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 48 weeks). The safety population was analysed for this end point, which included all subjects who received any amount of study drug.|From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)|Value of 0 represents the open-label portion of the trial|||Participants|||Count of Participants
2644978|NCT01714726|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) Double-blind Period|An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, lifethreatening, a congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug (Day 1) to 36 weeks post treatment (approximately 48 weeks). The safety population was analysed for this end point, which included all subjects who received any amount of study drug.|From study drug administration (Day 1) to 36 weeks post last blinded dose (up to 48 weeks)|Value of 0 represents the open-label portion of the trial|||Participants|||Count of Participants
2644979|NCT01714726|Secondary|Change From Baseline in CDAI Total Score at Week 8|The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. Subjects in the mITT population were analysed for this end point.|Week 8|Value of 0 represents the open-label portion of the trial|||Scores on a scale||Standard Error|Least Squares Mean
2644980|NCT01714726|Secondary|Percentage of Participants With CDAI Response at Week 12|The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI response is defined by either a CDAI score of < 150 or a CDAI reduction from baseline of at least 100 points, where baseline was the latest non-missing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.|Week 12|Value of 0 represents the open-label portion of the trial|||Percentage of Participants|||Number
2644981|NCT01714726|Secondary|Percentage of Participants With CDAI-70 Point Improvement at Week 8|The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI 70-point improvement is defined as a reduction from baseline in CDAI score of at least 70 points/scores, where baseline was the latest nonmissing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.|Week 8|Value of 0 represents the open-label portion of the trial|||Percentage of Participants|||Number
2644982|NCT01714726|Secondary|Percentage of Participants With CDAI-100 Point Improvement at Week 8|The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. CDAI 100-point improvement is defined as a reduction from baseline in CDAI score of at least 100 points/scores, where baseline was the latest nonmissing observation prior to first administration of the study drug. Subjects in the mITT population were analysed for this end point.|Week 8|Value of 0 represents the open-label portion of the trial|||Percentage of Participants|||Number
2644983|NCT01714726|Secondary|Percentage of Participants With CDAI Remission at Week 8|The CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days and includes subject reported symptoms, physician-assessed signs, and laboratory markers. The CDAI score is calculated by summing weighted scores for subjective items (number of liquid or very soft stools, the degree of abdominal pain over a week and general well-being; and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, and body weight). The CDAI scores range approximately from 0 to 600, with higher scores indicating greater disease activity. The CDAI score of < 150 represent CDAI remission. Subjects in the mITT population were analysed for this end point.|Week 8|Value of 0 represents the open-label portion of the trial|||Percentage of Participants|||Number
2644984|NCT01714726|Primary|Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response at Week 8|A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes subject reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = Sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (associated signs, use of anti-diarrhoeal medication, abdominal mass, haematocrit, daily morning temperature, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity. The CDAI response at Week 8 is defined as either CDAI score of less than (<)150 or CDAI reduction from baseline of at least 100 points, where baseline was last non-missing observation prior to first administration of the study drug. Modified Intent-to-treat (mITT)population was analysed for this end point, which included all subjects who were randomized and received at least 1 dose of study drug in double-blind period.|Week 8|Value of 0 represents the open-label portion of the trial|||Percentage of Participants|||Number
2644985|NCT01714687|Secondary|Return to Normal Activity|Days until return to normal activity (RTNA) assessed at 2 weeks post-procedure|2 week||||Days||Standard Deviation|Mean
2644986|NCT01714687|Secondary|Frequency of Second Procedure|Frequency of second procedure, ie the number of medical management subjects (sham arm) electing cross-over procedure.|Up to 24 weeks||||Participants|||Count of Participants
2644987|NCT01714687|Secondary|Sinus Infections and Sinus Severity - Part 2|Comparison of patient-reported sinus infection severity for subjects randomized to BSD versus medical management.|24 Weeks|All available data for each follow-up visit is presented.|||Participants|||Count of Participants
2644988|NCT01714687|Secondary|Sinus Infections and Sinus Severity - Part 1|Comparison of number of post-enrollment sinus infections for subjects randomized to BSD versus medical management.|24 Weeks and 48 Weeks|All available data for each follow-up visit is presented.|||Sinus Infections||Standard Deviation|Mean
2644989|NCT01714687|Secondary|Unscheduled Medical Care Visits Due to Sinusitis|Comparison of unscheduled medical care visits due to sinusitis at 24 and 48 weeks for subjects randomized to BSD versus medical management.|24 Weeks and 48 Weeks|All available data for each follow-up visit is presented.|||Medical care visits||Standard Deviation|Mean
2644990|NCT01714687|Secondary|Medication Usage at 24 and 48 Weeks|Comparison of medication usage at 24 and 48 weeks (days oral antibiotics, oral steroids, topical intranasal steroid sprays, and 'atypical' topical steroids (drops or respules)) for subjects randomized to BSD versus medical management.|24 Weeks and 48 Weeks|All available data for each follow-up visit is presented.|||Days||Standard Deviation|Mean
2644991|NCT01714687|Secondary|RSDI Total and Sub-score Changes From Baseline Over 48 Weeks|"The Rhinosinusitis Disability Index (RSDI) is a 30-question survey which includes 3 individual subscales to measure physical, functional, and emotional scores as well as a total score. There is no specified recall period. Scale values include Never (minimum), Almost Never, Sometimes, Almost Always, Always (maximum).~RSDI scores range from 0 to 120. Subscores are averaged to calculate a total score. Higher score indicates increased impact of sinus disease.~The Secondary Endpoint is comparison of change in patient-reported QOL as measured by RSDI total, physical, functional, and emotional sub-scores at 8, 24 and 48 weeks for subjects randomized to BSD versus medical management.~Lower score indicates greater improvement (decreased impact of sinus disease)."|8, 24, and 48 Weeks|All available data for each follow-up visit is presented.|||scores on a scale||Standard Deviation|Mean
2644992|NCT01714687|Secondary|CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks|"The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey (0 Weeks (minimum) to 7-8 Weeks (maximum)) used to evaluate surgical outcomes for CRS patients. The CSS asks 3 questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score. The symptom‐based section contains pain or pressure, nasal congestion or difficulty to breathe through the nose, and rhinorrhea or postnasal drip. The medication‐based section contains: antibiotics, prescription nasal sprays, and sinus medications in pill form. The severity of symptoms is scored 0 (none) to 4 (severe), and a total score is calculated from 0 (worst) to 100 (best). The Secondary Endpoint is the comparison of change as measured by average CSS medication and sinusitis symptom sub-scores over 24 and 48 weeks, and average total CSS score over 48 weeks for subjects randomized to BSD versus medical management. Higher score indicates greater improvement."|8, 16, 24, 32, 40, and 48 Weeks|All available date for each follow-up visit is presented.|||scores on a scale||Standard Deviation|Mean
2645020|NCT01714323|Secondary|Point Prevalence Tobacco Abstinence|7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report|1 month, 3 months, 6 months||||Participants|||Count of Participants
2646234|NCT01705080|Secondary|Mean Change in Ambulatory Systolic Blood Pressure at 24 Months||Baseline and 24 months||||mmHg||Standard Deviation|Mean
2644993|NCT01714687|Primary|CSS Total Score Change From Baseline to 24 Week Visit|"The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey to evaluate surgical outcomes for CRS patients. The CSS asks three questions about symptoms and three questions about medication usage and yields a symptom subscore, a medication subscore, and a total score. Scale values include 0 Weeks (minimum), 1-2 Weeks, 3-4 Weeks, 5-6 Weeks, and 7-8 Weeks (maximum).~The severity of symptoms is scored 0 (none) to 4 (severe), and a total score is calculated from 0 (worst) to 100 (best). Subscores are averaged to calculate a total score. Higher score indicates better outcomes.~The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects randomized to BSD versus medical management only.~Change is assessed by using the Mean Change for the CSS total score at 24 weeks compared to baseline. (24-week CSS total score minus Baseline CSS total score).~Higher score indicates greater improvement."|24 Week Visit||||scores on a scale||Standard Deviation|Mean
2644994|NCT01714635|Secondary|Spectacle Independence|Number of subjects never requiring spectacles at six months. This outcome measure was obtained via questionnaire. The questionnaire was administered by phone.|six months|Five subjects (3 from Group #1 [145-142], 1 from Group #2 [150-149], and 1 from the monofocal control group [146-145]) did not complete the questionnaire because they were unavailable, refused to complete it, implant status precluded completion (bilateral implants required), or failed to answer this particular question.|||participants|||Number
2644995|NCT01714635|Secondary|Mean Diopter Range With VA of 20/40 or Better|"Mean diopter range in which VA of 20/40 or better was achieved at six months. Note: diopter range outcome measure was obtained from a substudy group that included the first 10 study sites to reach enrollment goals. Among these 10 sites, the first 60 subjects in each lens group (approximately*) to reach the 6-month visit were included in the substudy.~* The intent was to enroll 60 subjects per group, but group #1, group #2, and the monofocal group had 59, 63, and 61 subjects, respectively."|six months|eyes|||diopters||Standard Deviation|Mean
2644996|NCT01714635|Primary|Mean Monocular Distance-corrected Near Visual Acuity (VA) at 40 cm|Mean (LogMAR) monocular distance-corrected near VA at 40 cm at six months postoperative|six months|eyes|||LogMAR VA||Standard Deviation|Mean
2644997|NCT01714609|Primary|Patients With Change in HVPG From Baseline|Number of participants with a decrease in HPVG that was > 10% of baseline|Three Months||||participants|||Number
2644998|NCT01714544|Primary|Investigator's Global Assessment (IGA)|The proportion of subjects who demonstrate an IGA score of clear (0) or almost clear (1).|28 days|Intent to treat population, with LOCF for missing data|||percentage of subjects||95% Confidence Interval|Number
2644999|NCT01714505|Primary|Safety, Frequency of Hypoglycemia|Hypoglycemic episodes are defined as BG < 3.9mmol/L|40 hours (x 2 admissions)||||hypoglycemic episodes/participant||Standard Deviation|Mean
2645000|NCT01714505|Secondary|Efficacy, Time Spent in Target Range|Percentage of time in the target range of 3.9-10 mmol/L (70-180 mg/dL).|40 hours (x2 admissions)||||percentage of time spent in range||Standard Deviation|Mean
2645001|NCT01714505|Primary|Safety, Low Blood Glucose Index (LBGI)|"The LBGI reflects the frequency and extent of hypoglycemic episodes and presents the results in risk space. Thus the LBGI is a weighted average of the number of hypoglycemic readings, with progressively increasing weights as BG levels go down. The increase of the weights follows a risk function; thus the LBGI has been associated with risk for hypoglycemia and prediction of severe hypoglycemic episodes.~LBGI < 2.5 is associated with low risk of hypoglycemia, 2.5 < LBGI < 5 is associated with a moderate risk of hypoglycemia and LBGI > 5 is associated with a high risk of hypoglycemia."|40 hours (x2 admissions)||||index score||Standard Deviation|Mean
2645002|NCT01714492|Secondary|Condyle Contact Stress at Maximum Flexion During Deep Knee Bend Activity||10 yrs post-operative||||MPa|Implants|Standard Deviation|Mean
2645003|NCT01714492|Secondary|Condyle Contact Area at Maximum Flexion During Deep Knee Bend Activity||10 yrs post-operative||||mm^2|Implants|Standard Deviation|Mean
2645004|NCT01714492|Primary|Range of Motion During Flexion of Deep Knee Bend Activity||10 yrs post-operative||||degrees|Implants|Standard Deviation|Mean
2645005|NCT01714492|Primary|Femoral Axial Rotation With Respect to the Tibia During Deep Knee Bend Activity||10 yrs post-operative||||degrees|Implants|Standard Deviation|Mean
2645006|NCT01714492|Secondary|In Vivo Knee Force Values From Fluoroscopy Evaluation During Deep Knee Bend Activity|"The intended unit of measure is times Body Weight (or xBW), relating to a ratio."|10 yrs post-operative|Subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation|||times body weight|Implants|Standard Deviation|Mean
2645007|NCT01714492|Primary|In Vivo Linear Knee Kinematics From Fluoroscopy Evaluation During Deep Knee Bend Activity|The values that were reported indicate the motion of the contact point from full extension to patient's maximum flexion. Throughout flexion, if the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative.|10 yrs post-operative|Subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.|||mm|Implants|Standard Deviation|Mean
2645008|NCT01714336|Secondary|Number of Participants Who Died|All-cause mortality at 6 months|6 months after surgery||||participants|||Number
2645009|NCT01714336|Secondary|Number of Participants With Cerebrovascular Accident (CVA) Diagnosis|CVA diagnosed within 6 months of surgery|Within 6 months of surgery||||participants|||Number
2645010|NCT01714336|Secondary|Number of Participants With Myocardial Infarction (MI) Diagnosis|MI diagnosed within 6 months of surgery|Within 6 months of surgery||||participants|||Number
2645011|NCT01714336|Secondary|Number of Participants With Wound Complications|Wound complications diagnosed within 6 months of surgery|Within 6 months of surgery||||participants|||Number
2645012|NCT01714336|Secondary|Number of Participants With Venous Thromboembolism (VTE) Diagnosis|Incidence of symptomatic VTE diagnosed within 6 months of surgery|Within 6 months of surgery||||participants|||Number
2645013|NCT01714336|Secondary|Calculated Blood Loss|Calculated blood loss|5 days||||cc||Standard Deviation|Mean
2645014|NCT01714336|Secondary|Mean Number of Units Transfused|Mean number of units transfused per patient|5 days||||units/participant transfused||Standard Deviation|Mean
2646235|NCT01705080|Secondary|Mean Change in Ambulatory Systolic Blood Pressure at 12 Months||Baseline and 12 months||||mmHg||Standard Deviation|Mean
2645032|NCT01714310|Secondary|Revised Modified Overt Aggression Scale - Total Score|A parent rated retrospective dimensional assessment of oppositional and aggressive behaviors, with scores ranging from 0-40, and higher scores indicating greater severity.|Baseline through week 12.|Some participants discontinued as trial progressed.|||units on a scale||Standard Error|Least Squares Mean
2645033|NCT01714310|Secondary|Affective Reactivity Index - Parent Report|A parent completed dimensional measure of emotional reactivity, with scores ranging from 0-12, and higher scores indicating greater severity.|Baseline through week 12.|Some participants discontinued as trial progressed.|||units on a scale||Standard Error|Least Squares Mean
2645034|NCT01714310|Secondary|Conners Teacher Global Index|Teacher completed dimensional measure of ADHD symptoms, with scores ranging from 0 - 30, and higher scores indicating more severe impairment.|Baseline through week 3.|Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinued as trial progressed.|||units on a scale||Standard Error|Least Squares Mean
2645035|NCT01714310|Secondary|Conners Global Index Restless-Impulsive Subscale Parent Report|A dimensional parent report measure of restless-impulsive symptoms, with scores ranging from 0 to 21, and higher scores indicating greater impairment.|Baseline through week 3.|Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinued as trial progressed.|||units on a scale||Standard Error|Least Squares Mean
2645036|NCT01714310|Secondary|Conners Global Index Emotional Lability Subscale - Parent Report|A sub scale of the Conners Global Index, with scores ranging from 0 - 12, with higher scores indicating more impairment.|Baseline to week 3.|Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participants discontinues as trial progressed.|||units on a scale||Standard Error|Least Squares Mean
2645037|NCT01714310|Secondary|Conners Parent Global Index|Parent completed dimensional measure of ADHD symptoms, with score range from 0 - 30 and higher scores indicating more severe symptoms.|Baseline through week 3.|Participants were assessed on this measure only during the Open Lisdexamfetamine phase. Some participant discontinued as trial progressed.|||units on a scale||Standard Error|Least Squares Mean
2645038|NCT01714310|Secondary|ADHD-IV Rating Scale|A dimensional rating of ADHD symptoms, with scores ranging from 0 - 54, and higher scores indicating greater symptom severity.|Baseline through week 12.|Participants discontinued as trial progressed.|||units on a scale||Standard Error|Least Squares Mean
2645039|NCT01714310|Primary|Clinical Global Impression-Severity-Severe Mood Dysregulation|A dimensional clinician rating of overall SMD related impairment, modified by the National Institute of Mental Health to assess specific domains pertinent to Severe Mood Dysregulation. Minimum score = 1. Maximum score = 7. Higher scores means greater impairment.|Baseline through week 12.|Compares groups lisdexamfetamine plus fluoxetine vs. lisdexamfetamine plus placebo over 12 week trial. Some participants discontinued as trial progressed.|||units on a scale||Standard Error|Least Squares Mean
2645040|NCT01714232|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)|"Using samples with Blood Glucose >180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value."|8 hours|Same number (113) of BG results was possible for each BGMS. Staff collected capillary samples from each subject as described in primary objective population description, of which 113 samples were greater than 180 mg/dL.|||Percent Difference|Participants|Standard Error|Mean
2645041|NCT01714232|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range(<=80 mg/dL)|"Using fresh and glycolyzed samples with Blood Glucose (BG) <=80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value."|8 hours|Same number (93) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 314), of which 93 samples were less than or equal to 80 mg/dL.|||Percent Difference|Participants|Standard Error|Mean
2645042|NCT01714232|Primary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range|"Using the overall Blood Glucose (BG) range (27 to 460 mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value."|8 hours|314 BG results possible for each BGMS (318-4=314). Staff collected 3 capillary samples from each subject-total 318 samples. One subject hematocrit(56%) was above the study evaluable limit 55%, so that subject's 3 samples were not analyzed. One sample from another subject was below meter operating limit (12.3mg/dL) so it was not analyzed.|||Percent Difference||Standard Error|Mean
2645043|NCT01714063|Other Pre-specified|Measurement Residual Amount of Drug (Fluticasone) Deposited Within the OptiChamber Diamond VHC|Collect the residual amount of drug (fluticasone) deposited within the OptiChamber Diamond VHC by washing the internal surfaces of the VHC and the Pressurized Metered Dose Inhaler (pMDI) boot|Day 1|This is a measure of an inhaler study, not a nebulizer study. Therefore this data was not collected or analyzed as it would not be applicable to this type of study.||||||
2646236|NCT01705080|Secondary|Mean Change in Ambulatory Systolic Blood Pressure at 6 Months||Baseline and 6 months||||mmHg||Standard Deviation|Mean
2645044|NCT01714063|Secondary|Inspiratory Tidal Volume|"Inspiratory tidal volume is a person's lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied. In a healthy, young human adult, tidal volume is approximately 500 mL per inspiration or 7 mL/kg of body mass.~This study compared the inspiratory tidal volume of all participants between the coordinated and uncoordinated maneuvers."|Day 1|"participant was excluded from both the coordinated because of their breathing profile~participants were excluded from the uncoordinated effort because of their breathing profile"|||mL||99% Confidence Interval|Mean
2645045|NCT01714063|Secondary|Inspiratory Peak Flow|"Inspiratory peak flow is a person's maximum speed of inspiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe in air.~This study compared the inspiratory peak flows of all participants between the coordinated and uncoordinated maneuvers."|Day 1|"participant was excluded from both the coordinated because of their breathing profile~participants were excluded from the uncoordinated effort because of their breathing profile"|||L/min||99% Confidence Interval|Mean
2645046|NCT01714063|Primary|Delivered Dose of Fluticasone (on the Filter) Comparing Coordinated and Uncoordinated Maneuvers|This is a measure of the the amount of fluticasone deposited onto a filter (delivered dose) during coordinated and uncoordinated actuation/inhalation maneuver. The coordinated maneuver occurs when the firing of the fluticasone is coordinated with the inhalation of the patient . An uncoordinated maneuver occurs when the firing of the fluticasone is coordinated with the exhalation of the patient.|Day 1|1 participant was excluded from the filter data because they were an outlier|||Percent filter dose of fluticasone||99% Confidence Interval|Mean
2645047|NCT01714063|Primary|Delivered Dose of Fluticasone (on the Filter)|This is a measure of the the amount of fluticasone deposited onto a filter (delivered dose) during coordinated and uncoordinated actuation/inhalation maneuver. The coordinated maneuver occurs when the firing of the fluticasone is coordinated with the inhalation of the patient . An uncoordinated maneuver occurs when the firing of the fluticasone is coordinated with the exhalation of the patient.|Day 1||||Percent filter dose of fluticasone||99% Confidence Interval|Mean
2645048|NCT01714024|Secondary|Group Based Differences (i.e. Healthy, Osteopenic and Diabetic) in Gene Expression Using Fold Changes Between Titanium and Trabecular at 4 Weeks.|Findings from expression arrays will be used to perform quantitative PCR analyses using SAB Superarrays (SuperArray GEArray), to enable a quantitativeassay of mRNA levels of specific inflammatory and growth factor molecules|4 weeks||||Fold Change||Standard Deviation|Mean
2645049|NCT01714024|Primary|Fold Change in Gene Expression Comparing Trabecular Metal to Standard Titanium.|Samples were analyzed comparing the osteogenic potential associated with titanium and porous tantalum dental implants (cylinders) at 2 and 4 weeks using transcriptome analyses. The primary outcome data are displayed showing the Average Delta ∆ (Ct) for osteogenic genes relative to the housekeeping markers. The numerical value of the CT is inversely related to the amount of amplicon in the reaction (i.e., the lower the CT, the greater the amount of amplicon).|2 weeks & 4 weeks post placement||||Average Delta ∆ (Ct)||Standard Deviation|Mean
2645050|NCT01713998|Secondary|Subject Assessment of Improvement at 180 Days Post-treatment|Subjects completed a Patient Assessment Questionnaire at 180 days post-treatment by referring to their image in a mirror, their 180-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.|180 days post-treatment||||percentage of participants|||Number
2645051|NCT01713998|Secondary|Subject Assessment of Improvement at 90 Days Post-treatment|Subjects completed a Patient Assessment Questionnaire at 90 days post-treatment by referring to their image in a mirror, their 90-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.|90 days post-treatment||||percentage of participants|||Number
2645052|NCT01713998|Secondary|Quantitative Assessment of Brow Lift at 90 Days Post-treatment|Quantitative assessment and analysis of brow lift from baseline to 90 days post-treatment was completed comparing brow lift achieved using standard energy settings compared to adjusted energy settings. The number of subjects with 1 mm or more brow lift is reported. Note: Because the submental region was treated using standard energy settings in all study groups, a quantitative analysis of lift in this region between the study groups would most likely not be informative, and therefore was not completed.|90 days post-treatment||||Participants|||Number
2645053|NCT01713998|Primary|Overall Improvement in Skin Laxity on the Face and Neck|A split-face comparison of improvement in overall lifting and tightening of skin was completed by three masked assessors. Pre-treatment and 90 days post-treatment photos from 45 subjects who returned for their 90-day follow-up visit were reviewed, assessing for improvement in skin laxity, i.e., lifted and tightened skin in the areas treated using treatment energy settings based on subjects' assigned study group.|90 days post-treatment||||Participants|||Number
2645054|NCT01713998|Primary|Subjects' Assessment of Pain During Treatment With Lower Energy Settings|"Subjects' sensory response to the Ulthera treatment exposures were recorded using a validated Numeric Rating Scale (NRS,0-10), for each anatomical region treated and energy settings used, with 0 representing no pain and 10 representing the worst pain possible.~Pain scores were collected in a consistent manner, following treatment of each section of the face and neck on both sides (submental, submandibular, cheek, periorbital, infraorbital, and forehead), and for each transducer used. Split-face comparisons of pain scores obtained during study treatment by research staff blinded to the energy settings used were completed."|Participants were assessed for the duration of study treatment, an average of 75 minutes||||units on a scale||Full Range|Mean
2645055|NCT01713946|Secondary|Long Term Evaluation: Incidence of Suicide Attempt, Suicidal Ideation or Behavior During Core Phase Per Columbia Suicide Severity Rating Scale (C-SSRS) Outcomes|The C-SSRS was completed at each visit. The table below presents the number of patients who reported at least one completed suicide, one suicide attempt, one preparatory action toward imminent suicidal behavior, one suicidal ideation and one self-injurious behavior without suicidal intent at any time point after starting everolimus.|During everolimus treatment from start of everolimus up to permanent discontinuation of everolimus, an average of 2.3 years|The LTE Efficacy Set included 361 patients who received at least one dose of everolimus in Core and Extension phase and had at least one valid post-baseline efficacy evaluation.|||Participants|||Number
2646237|NCT01705080|Secondary|Mean Change in Ambulatory Diastolic Blood Pressure at 48 Months||Baseline and 48 months|Data were not collected for participants in Group C and Unassigned Group at 48 months.|||mmHg||Standard Deviation|Mean
2645056|NCT01713946|Secondary|Core Phase: Incidence of Suicide Attempt, Suicidal Ideation or Behavior During Core Phase Per Columbia Suicide Severity Rating Scale (C-SSRS) Outcomes|"Comparison of suicidality using the C-SSRS in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm. The Columbia-Suicide Severity Rating Scale (C-SSRS) is a questionnaire used for suicide assessment developed by multiple institutions, including Columbia University, with NIMH support. The scale is evidence-supported and is part of a national and international public health initiative involving the assessment of suicidality. There are different scoring systems depending on the population. The important elements to note are that the higher the scores on the individual items and the more yes items, the higher the suicide risk."|Baseline, Week 18|The Safety Set comprised all patients who received at least one dose of study treatment and had at least one post-Baseline safety assessment in the Core phase (where the statement that a patient had no AE constitutes a safety assessment).|||Participants|||Number
2645057|NCT01713946|Secondary|Seizure Free Rates by Time Window|Percentage of seizure-free participants for each 12-week time window.|Weeks 18, 30, 42, 54, 66, 78, 90 & 102|The LTE Efficacy Set included 361 patients who received at least one dose of everolimus in Core and Extension phase and had at least one valid post baseline efficacy evaluation.|||Percentage of seizure-free participants||95% Confidence Interval|Number
2645058|NCT01713946|Secondary|Long Term Evaluation: Percentage Change From Start of Everolimus in Seizure Frequency by Time Window|"Percentage change from start of everolimus in average weekly seizure frequency (SFcfe) = 100 × (SFe - SFtw) ÷ SFe where:~SFe is the average weekly seizure frequency in the 8-week period before start of everolimus SFtw is the average weekly seizure frequency in a 12-week time window A positive percentage change from start of everolimus (SFcfe) means a reduction in seizure frequency whereas a negative percentage change from start of everolimus (SFcfe) means an increase in seizure frequency."|Baseline (8-week period before start of everolimus), Week 7 to 18, Week 19 to 30, and 12 weeks thereafter up to Week 102|The LTE Efficacy Set included 361 patients who received at least one dose of everolimus in Core and Extension phase and had at least one valid postbaseline efficacy evaluation.|||Percent change||95% Confidence Interval|Median
2645059|NCT01713946|Secondary|Core Phase: Impact of Everolimus on Anti-epileptic Drugs (AEDs) Concentrations|Impact of everolimus on AED concentrations at trough. Pre-dose plasma samples to measure AED concentrations were measured at at Visits 1 (Screening), 2 (Baseline), 3, and 5. Effects of everolimus on the exposure of antiepileptic drugs was assessed by comparing the anti-epileptic drug concentrations at Visits 1 and 2 (AEDs alone) and at Visits 3 and 5 (AEDs plus everolimus).|Baseline, Weeks 1 & 3|Confirmed PK Sample Set from all everolimus-treated patients in the Safety Set and Long-term Evaluation (LTE) Safety Set was defined as: Cmin collected prior to dose administration on the same treatment day and 20-28 hours after the previous dose, at steady state, and with no evidence of vomiting within 4 hours of the previous dose.|||ng/mL||90% Confidence Interval|Geometric Mean
2645060|NCT01713946|Secondary|Long Term Evaluation: Relationship Between Seizure Frequency and Time-normalized Everolimus Concentration at Trough (Cmin,TN) - Repeated Measures Analysis|A repeated measures analysis considering fixed 2-week intervals and including the level of exposure (time-normalized Cmin values), the time on-treatment and the seizure frequency at baseline quantified the estimated percentage change over 2 weeks in seizure frequency associated with a double exposure to everolimus, 15 days more on treatment and half the seizure frequency at baseline. A positive percentage change means a reduction in seizure frequency whereas a negative percentage change means an increase in seizure frequency.|During everolimus treatment from start of everolimus up to the end of the extension phase, an average of 1.7 year|Confirmed PK Sample Set from all everolimus-treated patients in the Longer-term Evaluation (LTE) Safety Set, was defined as follows: Cmin collected prior to dose administration on the same treatment day and 20-28 hours after the previous dose, at steady state, and with no evidence of vomiting within 4 hours of the previous dose|||% change over 2-wk in seizures freq.||95% Confidence Interval|Mean
2645061|NCT01713946|Secondary|Core Phase: Median Percentage Change From Baseline in Seizure Frequency by Time Normalized Minimum Concentration|Percentage change from baseline in average weekly seizure frequency during the maintenance period of the Core phase is calculated as follow: (SFcfb) = 100 × (SFB - SFM) ÷ SFB where SFB is the average weekly seizure frequency in the Baseline phase and SFM is the average weekly seizure frequency in the maintenance period of the Core phase. A positive percentage change from baseline (SFcfb) means a reduction in seizure frequency whereas a negative percentage change from baseline (SFcfb) means an increase in seizure frequency.|Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)|Confirmed PK Sample Set from all everolimus-treated patients in the Safety Set was defined as: Cmin collected prior to dose administration on the same treatment day and 20-28 hours after the previous dose, at steady state, and with no evidence of vomiting within 4 hours of the previous dose.|||Percentage change||95% Confidence Interval|Median
2645062|NCT01713946|Secondary|Core Phase: Response Rate in Seizure Frequency by Time Normalized Minimum Concentration|Comparison of response rate in seizure frequency for 5 categories of time-normalized minimum concentration (Cmin, TN) (< 3 ng/mL; 3-7 ng/mL; >7-<9 ng/mL; 9-15 ng/mL; >15 ng/mL). Response rate is the percentage of patients with ≥ 50% reduction from baseline in average weekly partial-onset seizure frequency during the maintenance period of the Core phase.|Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)|Confirmed PK Sample Set from all everolimus-treated patients in the Safety Set was defined as: Cmin collected prior to dose administration on the same treatment day and 20-28 hours after the previous dose, at steady state, and with no evidence of vomiting within 4 hours of the previous dose.|||Percentage of responders||95% Confidence Interval|Median
2645069|NCT01713946|Secondary|Core Phase: Change From Baseline in the QOLCE Overall Quality-of-life Score for Patients <11 Years|Comparison of quality of life in the everolimus (from 3 age specific questionnaires) low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm at the end of the core phase. The Quality of Life Childhood Epilepsy (QOLCE) questionnaire, used for patients < 11 years at baseline, was completed by the patient's parent or caregiver. It consists of 16 subscales (13 multi-item scales and 3 single item scales) and one overall quality-of-life score. Scores range from 0-100, with higher scores corresponding to improved QoL. The Overall Quality of Life Score is computed by adding each subscale score for each individual and then dividing by 16.|Baseline, Week 18|The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization|||scores on a scale||Full Range|Median
2645063|NCT01713946|Secondary|Long Term Evaluation: Effect of Everolimus Over Time in the Overall Wechsler Nonverbal Composite Score|The brief version of the WNV consists of a 2-subtest battery: only Matrices and Recognition subtests for patients under 8, and Matrices and Spatial Span subtests for patients aged 8 to 21. Based on the raw scores obtained from the subtests, standardized z-scores were calculated for each subtest using the following formula: Zscore = (X - b)/Sb where X is the raw score of the subtest, b and Sb represent the mean and standard deviation respectively of the subtest score recorded at baseline for the study population. The composite WNV score was computed by summing up the Z-scores of the 3 subtests of the WNV (i.e. matrices, recognition, and coding for patients aged <8 years and matrices, spatial span, and coding for patients aged 8 to 21 years). The composite WNV score has no range|Baseline, Weeks 18, 42, 66 and 90|The Long Term Evaluation (LTE) efficacy set consists of all patients who received at least one dose of everolimus and had at least one efficacy assessment while on everolimus.|||scores on a scale||Full Range|Median
2645064|NCT01713946|Secondary|Core Phase: Change From Baseline in Wechsler Nonverbal Composite Score|The brief version of the WNV consists of a 2-subtest battery: only Matrices and Recognition subtests for patients under 8, and Matrices and Spatial Span subtests for patients aged 8 to 21. Based on the raw scores obtained from the subtests, standardized z-scores were calculated for each subtest using the following formula: Zscore = (X - b)/Sb where X is the raw score of the subtest, b and Sb represent the mean and standard deviation respectively of the subtest score recorded at baseline for the study population. The composite WNV score was computed by summing up the Z-scores of the 3 subtests of the WNV (i.e. matrices, recognition, and coding for patients aged <8 years and matrices, spatial span, and coding for patients aged 8 to 21 years). The composite WNV score has no range.|Baseline, Week 18|The safety Set comprised all patients who received at least one dose of study treatment and had at least one post-baseline safety assessment in the Core phase (where the statement that a patient had no AE constitutes a safety assessment.|||scores on a scale||Full Range|Median
2645065|NCT01713946|Secondary|Long Term Evaluation: Effect of Everolimus Over Time in the Overall Vineland-II Adaptive Behavior Composite (ABC) Score|Comparison of adaptive functioning using the VABS-II composite score in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm. The Vineland II assesses an individual's development of personal independence & social responsibility. The questionnaire contains 433 items which assess 15 subdomains organized into the five domains of Communication, Daily Living Skills, Socialization, Motor Skills and Maladaptive Behavior. The overall Adaptive Behavior Composite (ABC) score is obtained by summing the standard scores of the first four domain scores for patients aged less than 7 years, or the first 3 domain scores for patients aged 7 or older (the Maladaptive Behavior domain is optional). The ABC standard score ranges from 20 to 160 with a mean of 100 and a standard deviation of 15. Higher scores correspond to improved adaptive level. Note that 2 questionnaires with ABC scores<20 (data issues) were included in this analysis.|Baseline, Weeks 18, 42, 66 and 90|The Long Term Evaluation (LTE) efficacy set consists of all patients who received at least one dose of everolimus and had at least one efficacy assessment while on everolimus.|||scores on a scale||Full Range|Median
2645066|NCT01713946|Secondary|Core Phase: Change From Baseline in the Overall Vineland-II Adaptive Behavior Composite (ABC) Score|Comparison of adaptive functioning using the VABS-II composite score in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm. The Vineland II assesses an individual's development of personal independence & social responsibility. The questionnaire contains 433 items which assess 15 subdomains organized into the five domains of Communication, Daily Living Skills, Socialization, Motor Skills and Maladaptive Behavior. The overall Adaptive Behavior Composite (ABC) score is obtained by summing the standard scores of the first four domain scores for patients aged less than 7 years, or the first 3 domain scores for patients aged 7 or older (the Maladaptive Behavior domain is optional). The ABC standard score ranges from 20 to 160 with a mean of 100 and a standard deviation of 15. Higher scores correspond to improved adaptive level. Note that 2 questionnaires with ABC scores<20 (data issues) were included in this analysis.|Baseline, 18 weeks|The safety Set comprised all patients who received at least one dose of study treatment and had at least one post-baseline safety assessment in the Core phase (where the statement that a patient had no AE constitutes a safety assessment).|||scores on a scale||Full Range|Median
2645067|NCT01713946|Secondary|Core Phase: Change From Baseline in the QOLIE-31-P Overall Quality-of-life Score for Patients Aged >=18 Years|Comparison of quality of life (from 3 age specific questionnaires) in the everolimus low-trough treatment arm (3-7 ng/mL), hightrough treatment arm (9-15 ng/mL) and placebo arm at the end of the core phase. The Quality of Life in Epilepsy Inventory-31-Problems (QOLIE-31-P) is a survey of health-related quality of life for adults with epilepsy. The QOLIE-31-P is completed by the patient. It contains 39 items, of which a total of 30 are used to make up 7 different subscales. Scores range from 0-100, with higher scores indicating a greater level of functioning and QoL. The overall quality of life score is obtained by summing a linear combination of the 7 subscale scores, where each subscale is multiplied by a relative weight that is obtained from the patient's answer to 7 items of this questionnaire.|Baseline, Week 18|The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization|||scores on a scale||Full Range|Median
2645068|NCT01713946|Secondary|Core Phase: Change From Baseline in the QOLIE-AD-48 Overall Quality-of-life Score for Patients >=11 to 18 Years|Comparison of quality of life (from 3 age specific questionnaires) in the everolimus low-trough treatment arm (3-7 ng/mL), hightrough treatment arm (9-15 ng/mL) and placebo arm at the end of the core phase. The Quality of Life in Epilepsy Inventory for Adolescents-48 (QOLIE-AD-48) is a survey of health-related quality of life for adolescents 11 to 18 years of age with epilepsy. The QOLIE-AD-48 is completed by the patient. It contains 48 items which assess 8 subscales. Scores range from 0-100, with higher scores corresponding to improved QoL. The overall quality of life score is obtained by summing a linear combination of the 8 subscale scores, where each subscale is multiplied by a relative weight that is provided in the original publication.|Baseline, Week 18|The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization|||scores on a scale||Full Range|Median
2645131|NCT01713283|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2646238|NCT01705080|Secondary|Mean Change in Ambulatory Diastolic Blood Pressure at 36 Months||Baseline and 36 months||||mmHg||Standard Deviation|Mean
2645070|NCT01713946|Secondary|Core Phase: Probability That a Patient Remains On-treatment up to a Specified Time Point|"Comparison of time to treatment discontinuation in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm during the core phase. Treatment duration is defined as the time from randomization until the date of permanent study treatment discontinuation (for any reason) at any time during the Core phase.~The percentage event-free probability estimate is the estimated probability that a patient will remain on-treatment up to a specified time point (Week 6, 12, 18)"|Week 6, Week 12, Week 18|The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization|||Percentage event-free prob. estimates||95% Confidence Interval|Number
2645071|NCT01713946|Secondary|Core Phase: Changes From Baseline in Number of Seizure-free Days|Comparison of seizure-free days relative to baseline in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm during maintenance period of the core phase|Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)|The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization|||Number of seizure-free days -per 28 days||Full Range|Median
2645072|NCT01713946|Secondary|Core Phase: Distribution of Reduction From Baseline in Seizure Frequency|Comparison of percentage of patients in six categories of seizure reduction from baseline (≤ -25% (exacerbation); > -25% to < 25% (no change); ≥ 25% to < 50%; ≥ 50% to < 75%; ≥ 75% to < 100%; 100% (seizure-freedom)) in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm during maintenance period of the core phase|Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)|The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization|||Percentage of participants|||Number
2645073|NCT01713946|Secondary|Core Phase: Percentage of Patients With at Least a 25% Reduction in Seizure Frequency|Comparison of percentage of patients with at least ≥ 25% reduction in seizure frequency in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm during maintenance period of the core phase. At least 25% reduction from baseline in partial-onset seizure frequency during maintenance period of the core phase.|Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)|The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization|||Percentage of participants||95% Confidence Interval|Number
2645074|NCT01713946|Secondary|Percentage of Seizure-free Patients During the Maintenance Period of the Core Phase|Comparison of seizure freedom (100% reduction in seizure frequency) in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm during maintenance period of the core phase. Seizure free means a 100% reduction from baseline in partial-onset seizure frequency during maintenance period of the core phase.|Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)|The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization|||Percentage of seizure-free participants||95% Confidence Interval|Number
2645075|NCT01713946|Primary|Core Phase: Food & Drug Administration (FDA): Percentage Change From Baseline in Partial Onset-seizure Frequency|"Comparison of median percent change from baseline in weekly seizure frequency in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm during maintenance period of the core phase. Percentage change from baseline in average weekly seizure frequency during the maintenance period of the Core phase (SFcfb) = 100 × (SFB - SFM) ÷ SFB where:~SFB is the average weekly seizure frequency in the Baseline phase SFM is the average weekly seizure frequency in the maintenance period of the Core phase A positive percentage change from baseline (SFcfb) means a reduction in seizure frequency whereas a negative percentage change from baseline (SFcfb) means an increase in seizure frequency."|Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)|The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization|||Percentage change from baseline||95% Confidence Interval|Median
2645076|NCT01713946|Primary|Core Phase: European Medicine Agency (EMA): Seizure Frequency Response Rate|Comparison of response rates in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm. Response means at least a 50% reduction from baseline in partial-onset seizure frequency during the maintenance period of the core phase.|Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)|The Full Analysis Set (FAS) comprised all patients to whom study treatment was assigned by randomization|||Percentage of responders||95% Confidence Interval|Number
2645077|NCT01713933|Secondary|Patient Satisfaction|Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.|Baseline to 180 days post-treatment|Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.|||Percentage of Participants|||Number
2645078|NCT01713933|Secondary|Patient Satisfaction|Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated how satisfied they were with study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment.|Baseline to 90 days post-treatment|wenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.|||Percentage of Participants|||Number
2645079|NCT01713933|Secondary|Overall Aesthetic Improvement|"Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse"|Baseline to180 days post-treatment|Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.|||Percentage of Participants|||Number
2645080|NCT01713933|Secondary|Overall Aesthetic Improvement|"Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse"|Baseline to 90 days post-treatment|Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.|||Percentage of Participants|||Number
2645081|NCT01713933|Secondary|Overall Aesthetic Improvement|"Based on Global Aesthetic Improvement Scale (GAIS) Scores; PGAIS completed by a physician assessor, SGAIS completed by the study subject. . The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse"|Baseline to 60 days post-treatment|Thirty-one (31) subjects returned for the 60 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.|||Percentage of Participants|||Number
2645082|NCT01713933|Secondary|Change in Dermal Thickness|Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 180 days post-treatment was calculated.|Baseline to180 days post-treatment|Thirty-one (31) subjects returned for the 180 day post-treatment visit. Two subjects were lost-to-follow-up. One subject was excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period.|||Millimeters||Full Range|Mean
2645083|NCT01713933|Secondary|Change in Dermal Thickness|Based on ultrasonic skin analysis, the change in dermal thickness from baseline to 90 days post-treatment was calculated.|Baseline to 90 days post-treatment|Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.|||Millimeters||Full Range|Mean
2645084|NCT01713933|Secondary|Quantitative Improvement in Skin Laxity|Assess change in brachial volume based on brachial tissue measurements.|Baseline to 90 days post-treatment|Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including one subject excluded from analyses as an outlier due to high BMI and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.|||percentage of participants improved|||Number
2645085|NCT01713933|Primary|Improvement in Obtaining Lift and Tightening of Brachial Skin Laxity|Improvement in overall lifting and tightening of brachial skin laxity as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.|Baseline to 90 days post-treatment|Twenty-seven (27) subjects returned for the 90 day post-treatment visit. Five (5) 90 day visits were missed, including the one subject excluded from analyses as an outlier due to high Body Mass Index (BMI) and substantial weight gain during the study period. Two (2) subjects were lost-to-follow-up.|||percentage of participants improved|||Number
2645086|NCT01713868|Secondary|Number of Participants Reporting Positive/Nonpositive Social Norms re: Roomsharing Without Bedsharing.|Social norms were assessed by asking if the people most important to the mother thought that the baby should sleep in each position or location. Positive social norms were defined as having positive norms toward the recommended behavior AND not having positive norms toward other behaviors|6 months|All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep.|||Participants|||Count of Participants
2645087|NCT01713868|Secondary|Number of Participants Reporting Positive/Nonpositive Social Norms re Supine Sleep|Social norms were assessed by asking if the people most important to the mother thought that the baby should sleep in each position or location. Positive social norms were defined as having positive norms toward the recommended behavior AND not having positive norms toward other behaviors.|6 months|All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep|||Participants|||Count of Participants
2645088|NCT01713868|Secondary|Number of Participants Reporting Positive/Nonpositive Attitudes Towards Roomsharing Without Bedsharing.|Questions assessing attitudes toward sleep location (bedsharing, roomsharing without bedsharing) assessed whether the location was pleasant for the baby and/or mother, safer for the baby, more comfortable for the baby and/or mother, and kept the baby from choking. Positive attitudes were defined as having positive attitudes toward the recommended behavior AND not having positive attitudes toward other behaviors (e.g., having positive attitudes towards both bedsharing and not bedsharing would lead to a categorization of not having positive attitudes towards bedsharing only).|6 months|All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep.|||Participants|||Count of Participants
2645089|NCT01713868|Secondary|Number of Participants Reporting Positive/Nonpositive Attitudes Towards Supine Sleep|Questions assessing attitudes toward sleep position included the mothers' ratings regarding if she believed that each infant sleep position (back, side, stomach) made the baby healthy, safer, more comfortable, and kept the baby from choking. Positive attitudes were defined as having positive attitudes toward the recommended behavior AND not having positive attitudes toward other behaviors (e.g., having positive attitudes towards both supine and side sleep would lead to a categorization of not having positive attitudes towards supine sleep only).|6 months|All 4 arms received a combination of education (breastfeeding or safe sleep) and mHealth (breastfeeding or safe sleep). Only the mHealth interventions were effective. Thus, for this analysis, we collapsed the arms to 2 arms: received mHealth breastfeeding and received mHealth safe sleep.|||Participants|||Count of Participants
2645205|NCT01712490|Secondary|Positron Emission Tomography (PET) Negativity Rate Per IRF at Cycle 2|PET negativity rate at Cycle 2 was defined as the percentage of participants with negative Cycle 2 PET results defined as Deauville score less than or equal to (<=) 3 at Cycle 2. The Deauville score according to IRF assessment of response was used to evaluate the results of PET scans.|Cycle 2 Day 25|The ITT population included all participants randomized to treatment.|||percentage of participants|||Number
2645090|NCT01713868|Primary|Adherence With Recommended Avoiding Use of Soft Bedding|Hypothesis: For each recommended avoidance of soft bedding use, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.|6 months||||Participants|||Count of Participants
2645091|NCT01713868|Primary|Adherence With Recommended Pacifier Use|Hypothesis: For pacifier use, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.|6 months||||Participants|||Count of Participants
2645092|NCT01713868|Primary|Adherence With Recommended Roomsharing Without Bed Sharing|Hypothesis: For roomsharing without bed sharing, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.|6 months||||Participants|||Count of Participants
2645093|NCT01713868|Primary|Adherence With Recommended Supine Sleep Position|Hypothesis:For supine sleep position, when controlling for other variables, there will be: a) an increased adherence for mothers who received Safe Sleep Nursery Education; b) an increased adherence for mothers who received Safe Sleep mHealth messaging; and c) compared to mothers who received either Safe Sleep Nursery Education or Safe Sleep mHealth messaging alone, an increased adherence for mothers who received both Safe Sleep Nursery Education and Safe Sleep mHealth messaging. Outcome measures will be assessed by survey conducted when the infant is 2-5 months of age.|6 months|Results analyzed at 2+ months infant age.|||Participants|||Count of Participants
2645094|NCT01713686|Secondary|Subject Satisfaction at 180 Days Post-treatment|"Subject satisfaction was measured at 180 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:~Very Satisfied~Satisfied~Neither Satisfied or Dissatisfied~Dissatisfied~Very Dissatisfied~Satisfied = Very Satisfied + Satisfied~Dissatisfied = Dissatisfied + Very Dissatisfied"|180 days post-treatment|This secondary outcome measure was based on the responses provided from 116 subjects completing a 180 day post-treatment visit.|||percentage of participants|||Number
2645095|NCT01713686|Secondary|Subject Satisfaction at 90 Days Post-treatment|"Subject satisfaction was measured at 90 days post-treatment using a Patient Satisfaction Questionnaire (PSQ). A 5-point PSQ scale was used with the following descriptors:~Very Satisfied~Satisfied~Neither Satisfied or Dissatisfied~Dissatisfied~Very Dissatisfied~Satisfied= Very Satisfied + Satisfied~Dissatisfied=Dissatisfied + Very Dissatisfied"|90 days post-treatment|This secondary outcome measure was based on the responses provided from 116 subjects completing a 90 day post-treatment visit.|||percentage of participants|||Number
2645096|NCT01713686|Primary|Percentage of Participants With a Reduction in Chest Wrinkles at 180 Days Post Treatment|"Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 180 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint, improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 180 days .post-treatment compared to baseline.~Improvement = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set and correctly chose the Post treatment photo.~Incorrect = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo."|180 days post treatment|The analysis population was based on the Last Value Carried Forward (LVCF) analysis method for determining overall efficacy, i.e., if a D90 but not D180 value was present, the LVCF is the D90 value. Following this method, the analysis popullation was based on 116 subjects.|||percentage of participants|||Number
2645097|NCT01713686|Secondary|Overall Aesthetic Improvement at 180 Days Post-treatment|"The overall level of aesthetic improvement at 180 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:~Very much improved~Much improved~Improved~No change~Worse~The scale was completed in two steps:~Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and~Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs.~Improved = Very Much Improved + Much Improved + Improved"|180 days post-treatment|Analysis population was based the number of subjects completing a 180 day follow-up visit.|||percentage of participants|||Number
2645098|NCT01713686|Secondary|Overall Aesthetic Improvement at 90 Days Post-treatment|"The overall level of aesthetic improvement at 90 Days post treatment compared to baseline was assessed using a Clinician Global Aesthetic Improvement Scale (CGAIS). The CGAIS is a 5-point scale with the following descriptors:~Very much improved~Much improved~Improved~No change~Worse~The scale was completed in two steps:~Based on a live assessment of the subject while referring to the subject's pre-treatment photographs; and~Based on a comparison of the subject's pre-treatment photographs to current post-treatment photographs.~Improved = Very Much Improved + Much Improved + Improved"|90 days post-treatment|This secondary outcome measure was based on 116 subjects completing a 90 day post-treatment visit.|||percentage of participants|||Number
2645153|NCT01713036|Secondary|Maximum Observed Plasma Concentration (Cmax) of Total [14C] Radioactivity|Unit of assessment was nanogram equivalent per milliliter (ng eq/mL).|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||ng eq/mL||95% Confidence Interval|Geometric Mean
2645099|NCT01713686|Primary|Percentage of Participants With a Reduction in Chest Wrinkles at 90 Days Post Treatment|"Assessment of improvement, in a blinded fashion, using a Chest Wrinkle Scale at 90 days post-treatment. However, during conduct of the trial, the Chest Wrinkle scale was deemed inadequate as a primary endpoint in this study. Therefore, conduct of a traditional blinded masked assessment, the gold-standard measure in aesthetics, was used as the primary endpoint,i.e., improvement in wrinkles and lines of the décolletage as determined by a blinded, masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline.~Improvement = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set and correctly chose the Post treatment photo.~Incorrect = a blinded evaluator assessed an Improvement when evaluating a masked, paired photo set but incorrectly chose the Post treatment photo."|90 Days post-treatment|The analysis population was based on data from subjects completing a 90 day follow-up visit. Of the 116 subjects who returned for the D90 follow-up, 113 subjects had evaluable photographs. These photos were treated as ‘missing’ by the statistician and were not included in the denominator for the masked assessment analyses.|||percentage of participants|||Number
2645100|NCT01713660|Secondary|Percent of Seidel Staining|Demonstration of no wound leakage as measured by Seidel test at slit lamp with fluorscein dye. A negative Seidel test result indicates no wound leakage.|Day 0 (performed immediately post-incision creation), Day 1||||percentage of eyes with negative Seidel|Participants||Number
2645101|NCT01713660|Secondary|Surgeon Assessment of Workflow|Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended?|Day 0, Operative||||percentage of yes answers|||Number
2645102|NCT01713660|Primary|Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.|Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured).|Day 0, Operative (Within 2 hours of incision creation)||||mm|Participants|Standard Deviation|Mean
2645103|NCT01713621|Primary|Minimum Inhibitory Concentration (MIC) and Minimum Parasiticidal Concentration (MPC)|The estimated MIC and MPC were derived from the fitted parasitaemia concentration and PK/PD relationship.|up to 28 days|Model predicted MIC and MPC|||ng/Ml||Standard Deviation|Mean
2645104|NCT01713608|Secondary|OZ439 t½|OZ439 estimated terminal phase half life|pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.|PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.|||hours||Standard Deviation|Mean
2645105|NCT01713608|Primary|OZ439 AUCτ|OZ439 Area under the plasma concentration vs time curve from time zero to the time of the last quantifiable concentration t calculated using a log-linear trapezoidal method|pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.|PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.|||ng*h/mL||Standard Deviation|Mean
2645106|NCT01713608|Secondary|OZ439 Tmax|Time to reach maximum measured OZ439 plasma concentration|pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.|PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.|||hours||Standard Deviation|Mean
2645107|NCT01713608|Primary|OZ439 Cmax|OZ439 maximum measured plasma concentration|Blood for analysis of OZ439 will be collected at the following times: pre-dose, 2, 4, 6, 8, 12, and 18 hours post-dose Day 1and Day 3, pre dose Day 2 and 4 hours post dose Day 2, and 24, 48, 72, 96 and 168 hours post 3rd dose and at follow up.|PK Population: All subjects who received at least one dose of study medication and who had available evaluable PK data.|||ng/mL||Standard Deviation|Mean
2645108|NCT01713582|Secondary|Volume of Distribution at Steady State (Vz/F) of MK-8628/OTX015|"Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.~Blood samples for Vz/F were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies."|Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position|All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.|||Liters||Standard Deviation|Mean
2645109|NCT01713582|Secondary|Apparent Total Body Clearance (CL/F) of MK-8628/OTX015|"Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.~Blood samples for CL/F were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies."|cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position|All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.|||L/hour||Standard Deviation|Mean
2645110|NCT01713582|Secondary|Area Under the Concentration Time Curve of MK-8628/OTX015 From Time 0 to Infinity (AUC 0-inf)|"Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.~Blood samples for AUC 0-first were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies."|Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position|All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.|||hr*ng/mL||Standard Deviation|Mean
2645111|NCT01713582|Secondary|Apparent Terminal Half-Life (t1/2) of MK-8628/OTX015|"Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.~Blood samples for t1/2 were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies."|Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position|All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.|||Hours||Standard Deviation|Mean
2645112|NCT01713582|Secondary|Time to Maximum Concentration (Tmax) of MK-8628/OTX015|"Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.~Blood samples for Tmax were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies."|Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position|All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.|||Hours||Standard Deviation|Mean
2645113|NCT01713582|Secondary|Maximum Concentration (Cmax) of MK-8628/OTX015|"Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24 hours (h) + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.~Blood samples for Cmax were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies."|Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position|All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.|||ug/L||Standard Deviation|Mean
2645114|NCT01713582|Secondary|Number of Participants Whose Best Response Was Partial Response (PR) or Complete Response (CR)|Best response was determined from the start of treatment until disease progression, recurrence, or completion of 26 months of treatment. Partial and complete response was assessed by bone marrow aspiration (AL participants); or computed tomography scan, magnetic resonance imaging, positron emission tomography, or X-ray (OHM participants) using standard criteria. Acute leukemia participants were assessed based on the recommendations from the European LeukemiaNet Döhner 2010); lymphoma participants according to Cheson 2007; and MM participants according to Durie 2006.|From time of first dose of study therapy until the end of treatment (up to 26 months)|All participants who received one dose of study therapy and had at least one available tumor assessment by the end of Cycle 2 or later or with earlier evidence of response or progression.|||Participants|||Number
2645115|NCT01713582|Secondary|Number of Participants Who Discontinued Study Therapy Due to AEs|All participants who discontinued study therapy due to an AE at any time during treatment.|From time of first dose of study therapy until the end of treatment (up to 26 months)|All participants who received at least one dose of study therapy.|||Participants|||Count of Participants
2646239|NCT01705080|Secondary|Mean Change in Ambulatory Diastolic Blood Pressure at 24 Months||Baseline and 24 months||||mmHg||Standard Deviation|Mean
2646240|NCT01705080|Secondary|Mean Change in Ambulatory Diastolic Blood Pressure at 12 Months||Baseline and 12 months||||mmHg||Standard Deviation|Mean
2645116|NCT01713582|Secondary|Number of Participants Who Experienced at Least One Adverse Event (AE)|AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. AEs were collected during the entire time frame of treatment plus up to 40 days of follow-up.|Up to 40 days after last dose of study therapy (Up to 28 months)|All participants who received at least one dose of study therapy.|||Participants|||Count of Participants
2645117|NCT01713582|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|A DLT was graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.02 and defined as any of the following: grade 3 or 4 non-hematologic adverse events unless they were not optimally treated with supportive care; grade 3 or 4 asymptomatic laboratory abnormal values lasting >7 days; prolonged grade 2 toxicity (lasting more than 2 weeks) leading to treatment interruption and/or dose reduction; pancytopenia with a hypocellular bone marrow and no marrow blasts lasting ≥6 weeks (AL participants); grade 3 neutropenia with fever or infection (OHM participants); grade 3 thrombocytopenia with bleeding (OHM participants); or grade 4 neutropenia or thrombocytopenia, regardless of symptoms and lasting ≥3 days (OHM participants).|Cycle 1 (Up to 21 days)|All participants who received at least 85% of the intended dose of study therapy during the first cycle (i.e. >12 days at full dose for AL and >18 days at full dose for other hematological malignancies) or discontinued from the study due to a DLT attributable to study therapy.|||Participants|||Count of Participants
2645118|NCT01713530|Secondary|Incidence of Treatment Emergent Adverse Events (TEAE)|A TEAE was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation “as treated”.|||number of events|||Number
2645119|NCT01713530|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes|Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.|Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation “as treated”.|||episodes|||Number
2645120|NCT01713530|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|"According to the American Diabetes Association (ADA) definition following are the categories of hypoglycaemic episodes:~Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Relative hypoglycaemia"|During Weeks 0-26|The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation “as treated”.|||episodes|||Number
2645121|NCT01713530|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|According to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured Plasma Glucose (PG) <3.1 mmol/L(56 mg/dL))|During Weeks 0-26|The safety Analysis Set (SAS): included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation “as treated”.|||episodes|||Number
2645122|NCT01713530|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects (2 subjects-baseline FPG not measured). The statistical evaluation of the FAS followed the ITT principle and subjects contributed to the evaluation “as randomised”.|||mmol/L||Standard Error|Least Squares Mean
2645123|NCT01713530|Primary|Change From Baseline in HbA1c (%)|Change from baseline in HbA1c (%) after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects. The statistical evaluation of the FAS followed the ITT principle and subjects contributed to the evaluation “as randomised”.|||percentage change in HbA1c||Standard Error|Least Squares Mean
2645124|NCT01713400|Secondary|Incidence of Acute Graft vs. Host Disease (AGVHD)|Cumulative incidence of Grade II - IV AGVHD to be characterized weekly from day of transplant to day 100 using the 1995 updated grading scheme for Graft vs. Host Disease (GVHD) developed by Glucksberg, et al.|100 days post transplant|All participating recipients|||percentage of participants|||Number
2645125|NCT01713400|Primary|T Regulatory Cell (Treg)/Total Cluster of Differentiation 4 (CD4)+ Ratio|"Median Blood Treg/Total CD4+ Ratio at day 30 following hematopoietic cell transplantation (HCT). Comparison between study arms: Ustekinumab vs. Placebo. From NCI Dictionary: T reg - A type of immune cell that blocks the actions of some other types of lymphocytes, to keep the immune system from becoming over-active. T regs are being studied in the treatment of cancer. A T reg is a type of white blood cell and a type of lymphocyte. Also called regulatory T cell, suppressor T cell, and T-regulatory cell."|30 days post transplant|All participating recipients|||ratio||Full Range|Median
2645126|NCT01713348|Secondary|HbA1c||Day 100 compared to day 1|Analysis performed according to the intention-to-treat principle.|||Percent||Standard Deviation|Mean
2645127|NCT01713348|Secondary|HbA1c (mmol/Mol)||Day 100 compared to day 1|Analysis performed according to the intention-to-treat principle. Analysis in the Type 1 population is after removal of 1 outlier.|||mmol/mol||Standard Deviation|Mean
2645128|NCT01713348|Secondary|Glucose Standard Deviation (SD)||Day 86 to 100 compared to day 1 to 15||||mmol/L||Standard Deviation|Mean
2645129|NCT01713348|Secondary|Time in Range|Difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) intervention arm compared to control arm.|Days 86 to 100 intervention arm compared to control arm|All analyses were performed according to the intention-to-treat principle.|||hours per day||Standard Deviation|Mean
2645130|NCT01713348|Primary|Time in Range|Intervention arm: within subject difference in time in range (70-180 mg/dL, 3.9 to 10.0 mmol/L) in final 15 days compared to baseline phase assessed separately for Type 1 and Type 2 Diabetes.|Day 86 to 100 compared to Day 1 to 15|All analyses were performed according to the intention-to-treat principle.|||hours per day||Standard Deviation|Mean
2646241|NCT01705080|Secondary|Mean Change in Ambulatory Diastolic Blood Pressure at 6 Months||Baseline and 6 months||||mmHg||Standard Deviation|Mean
2645132|NCT01713283|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as:~Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment"|Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
2645133|NCT01713283|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
2645134|NCT01713283|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants discontinuing any study drug due to an adverse event was summarized.|Up to 24 weeks|Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug|||percentage of participants|||Number
2645135|NCT01713283|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants with genotype 4 HCV infection who were randomized into the study and received at least 1 dose of study drug|||percentage of participants|||Number
2645136|NCT01713036|Secondary|Number of Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs Leading to Discontinuation|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug administration until 30+/-2 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pre treatment state.|Part A and B: From the first dose of study drug administration until 30+/-2 days after the last dose of study drug administration, assessed up to 18 months|The safety analysis set included all subjects who received at least one administration of trial medication and have at least one subsequent safety assessment.|||subjects|||Number
2645137|NCT01713036|Secondary|Part B: Number of Subjects Who Experienced Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD)|Anti tumor activity defined as CR, PR, or stable disease and PD based on the investigator tumor evaluations performed every 2 cycles in accordance with Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. CR =Disappearance of all target lesions except lymph nodes (LN); LN must have a decrease in the short axis to less than (<)10 millimeter (mm); PR = 30% decrease in sum of diameters of target lesions taking as reference the baseline sum diameters; Progressed Disease (PD) = 20% increase in sum of diameters of target lesions; the appearance of >=1 new lesions; SD= Neither shrinkage to qualify for PR nor increase to qualify for PD taking the smallest sum diameters on study as reference. For non-target lesions a CR = Disappearance of all non-target lesions and all LN must be non-pathological in size <10 mm; Non-CR/Non PD: persistence of one or more non-target lesions; PD = unequivocal progression of existing non-target lesions or appearance of new ones.|From the screening every 2 cycles until end of the treatment, assessed up to 18 months|Safety analysis set included all subjects who received at least one administration of trial medication and had at least one subsequent safety assessment.|||subjects|||Number
2645138|NCT01713036|Secondary|Blood/ Plasma Concentration Ratios of Total [14C] Radioactivity||1.5 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||Ratio||Standard Deviation|Mean
2645139|NCT01713036|Secondary|Fraction Unbound of [14C] Pimasertib|Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration multiplied by 100.|1.5 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||percentage of unbound drug||Standard Deviation|Mean
2645140|NCT01713036|Secondary|Apparent Terminal Half-life (t1/2) of M445 and M554||Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hour||Full Range|Median
2645141|NCT01713036|Secondary|Apparent Terminal Elimination Rate Constant (λz) of M445 and M554|The λz of M445 and M554 was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||per hour||95% Confidence Interval|Geometric Mean
2645142|NCT01713036|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of M445 and M554|AUC from time 0 to infinity (AUC0-inf), was calculated from AUC0-t + AUCextra, where AUCextra = Clast calc/lambda z (λz). Clast calc was the calculated plasma concentration at the last sampling time point at which plasma concentration was at or above the lower limit of quantification was measured and λz represents apparent terminal elimination rate constant.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hr*ng eq/mL||95% Confidence Interval|Geometric Mean
2645143|NCT01713036|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time (AUC0-t) of M445 and M554|Area under the plasma concentration-time curve from time zero to the last sampling time (AUC0-t) at which the concentration is at or above the lower limit of quantification.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hr*ng eq/mL||95% Confidence Interval|Geometric Mean
2645144|NCT01713036|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of M445 and M554|Time to reach maximum plasma concentration (Tmax) for the metabolites M445 and M554 was calculated.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hour||Full Range|Median
2645145|NCT01713036|Secondary|Maximum Observed Plasma Concentration (Cmax) of M445 and M554|Maximum observed plasma concentration (Cmax) for the metabolites M445 and M554 was calculated.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||Nanogram equivalent per milliliter||95% Confidence Interval|Geometric Mean
2645146|NCT01713036|Secondary|Apparent Volume of Distribution of Total [14C] Radioactivity During the Terminal Phase Following Oral Administration (Vz/f)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Vz/f of total radioactivity during the terminal phase was calculated by dividing the dose with the product of area under the plasma concentration time curve and apparent terminal rate constant (dose/AUC0inf*λz).|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||Liter||95% Confidence Interval|Geometric Mean
2645147|NCT01713036|Secondary|Total Body Clearance of Total [14C] Radioactivity From Plasma Following Oral Administration (CL/f)|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/f was influenced by the fraction absorbed. Apparent body clearance of total radioactivity from plasma was calculated by dividing the dose with area under the plasma concentration time curve from zero to infinity (Dose/AUC0inf).|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||liter per hour||95% Confidence Interval|Geometric Mean
2645148|NCT01713036|Secondary|Apparent Terminal Half-life (t1/2) of Total [14C] Radioactivity||Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hour||Full Range|Median
2645149|NCT01713036|Secondary|Apparent Terminal Elimination Rate Constant (λz) of Total [14C] Radioactivity|λz of total [14C] radioactivity was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||per hour||95% Confidence Interval|Geometric Mean
2645150|NCT01713036|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Total [14C] Radioactivity|Area under the concentration time curve (AUC) from time zero to infinity (AUC0-inf) was calculated from AUC0-t + AUCextra, where AUCextra = Clast calc/λz. Clast calc was the calculated plasma concentration at the last sampling time point at which plasma concentration was at or above the lower limit of quantification was measured and λz represents apparent terminal elimination rate constant.|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hr*ng eq/mL||95% Confidence Interval|Geometric Mean
2645151|NCT01713036|Secondary|Area Under the Plasma Concentration Time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Total [14C] Radioactivity|Area under the plasma concentration time curve from time zero to the last sampling time at which the concentration is at or above the lower limit of quantification was calculated by using mixed log linear trapezoidal rule. Unit of assessment was hour*nanogram equivalent per milliliter (hr*ng eq/mL).|Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hr*ng eq/mL||95% Confidence Interval|Geometric Mean
2645152|NCT01713036|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Total [14C] Radioactivity||Pre dose, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 4.0, 6.0, 8.0, 10.0, 12.0, 24.0, 48.0, 72.0, 96.0 and 168.0 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hour||Full Range|Median
2645154|NCT01713036|Secondary|Apparent Volume of Distribution During the Terminal Phase Following Oral Administration (Vz/f) and the Apparent Volume of Distribution During the Terminal Phase Following Intravenous Administration (Vz) of [14C] Pimasertib|The apparent volume of distribution during the terminal phase following oral administration (Vz/f) and the apparent volume of distribution during the terminal phase following intravenous administration was calculated by using the formula=Dose/( AUC0-inf* λz).|Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||Liter||95% Confidence Interval|Geometric Mean
2645155|NCT01713036|Secondary|The Volume of Distribution of the Central or Plasma Compartment (Vc) of Intravenous [14C] Pimasertib|The volume of distribution of the central or plasma compartment (Vc) was calculated using the formula=Dose/C0|Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post intravenous [14C] pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||Liter||95% Confidence Interval|Geometric Mean
2645156|NCT01713036|Secondary|Total Body Clearance of Unlabeled Pimasertib (CL/f) and Intravenous [14C] Pimasertib (CL)|The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the Dose with area under the plasma concentration time curve from time zero to infinity (AUC0 inf)=Dose/AUC0- inf.|Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post intravenous [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||liter per hour||95% Confidence Interval|Geometric Mean
2645157|NCT01713036|Secondary|Apparent Terminal Elimination Rate Constant (λz) of Unlabeled Pimasertib and Intravenous [14C] Pimasertib|Apparent terminal elimination rate constant (λz) was determined from the terminal slope of the log-transformed plasma concentration curve using linear regression on terminal data points of the curve.|Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post intravenous [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||per hour||95% Confidence Interval|Geometric Mean
2645158|NCT01713036|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Unlabeled Pimasertib and Intravenous [14C] Pimasertib||Pre-dose 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post intravenous [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hours||Full Range|Median
2645159|NCT01713036|Secondary|Maximum Observed Plasma Concentration (Cmax) of Intravenous [14C] Pimasertib||Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] intravenous pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||picogram equivalent per milliliter||95% Confidence Interval|Geometric Mean
2645160|NCT01713036|Secondary|Maximum Observed Plasma Concentration (Cmax) of Unlabeled Pimasertib||Pre-dose 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||ng/mL||95% Confidence Interval|Geometric Mean
2645161|NCT01713036|Primary|Number of Metabolites Identified Overall and as Major|Identification and profiling of the metabolites was done. The total number of metabolites and the number of metabolites identified as major were reported.|Pre-dose 1.0, 2.0, 4.0, 10 and 24 hours post [14C]-labeled Pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||metabolites|||Number
2645162|NCT01713036|Primary|Plasma Concentrations of Pimasertib Metabolites|Plasma concentration of the Pimasertib metabolite M445 and M554 were presented for the outcome measure.|Predose, 1.0, 2.0, 4.0, 10 and 24 hour post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A. Here 'n' is the number of subjects analysed at each time point.|||Nanogram equivalent per milliliter||Standard Deviation|Mean
2645163|NCT01713036|Primary|Plasma Concentrations of [14C] Pimasertib||Pre-dose 1.0, 2.0, 4.0, 10 and 24 hours post [14C]-labeled Pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||nanogram equivalent per milliliter||Standard Deviation|Mean
2645174|NCT01712984|Primary|Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.|Day 28 post-vaccination|Geometric mean titers against the influenza virus antigens were assessed in the Per-protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2646242|NCT01705080|Secondary|Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg at 6 Months||6 months post procedure||||Participants|||Count of Participants
2645164|NCT01713036|Primary|Mass Balance: Amount of Total Radioactivity Recovered Into the Urine and Feces From Time Zero to the Last Sampling Time Point (Ae0-t)|Recovery of total [14C]-radioactivity was determined in excreta, i.e., urine and feces at each sampling period subsequent to oral administration of [14C]-pimasertib on Day 8. Cumulative recovery of total [14C]-radioactivity in terms of percentage of dose recovered in urine and feces and total percentage of dose recovered was reported for the outcome measure.|Urine: 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, and 72-96 hours post [14C]-labeled pimasertib dose on Day 8; Feces: 0-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hours post [14C]-labeled pimasertib dose on Day 8|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||percentage of dose recovered||Full Range|Geometric Mean
2645165|NCT01713036|Primary|Oral Bioavailability of Pimasertib After Single Oral Dose of Unlabeled Pimasertib and Intravenous (IV) Single Tracer Dose of [14C] Pimasertib|Oral bioavailability (F) was calculated using the formula=AUC0-inf oral/dose oral) / (AUC0-inf iv/dose iv) * 100%, where AUC0-inf is the area under the concentration time curve (AUC) from time zero to infinity.|Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1; Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] labeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with investigational medicinal product (IMP) intake for the complete Part A.|||percentage bioavailability||90% Confidence Interval|Number
2645166|NCT01713036|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of Pimasertib Following Oral Administration on Day 1||Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hour*nanogram/milliliter||95% Confidence Interval|Geometric Mean
2645167|NCT01713036|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of [14C]‐Pimasertib Following IV Administration on Day 1||Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] intravenous pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hour*picogram equivalent/milliliter||95% Confidence Interval|Geometric Mean
2645168|NCT01713036|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to the Last Sampling Time Point (AUC0-t) of Pimasertib Following Oral Administration on Day 1||Pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 4, 6, 8, 10, 12, 16, 24, and 48 hours post unlabeled pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hour*nanogram/milliliter||95% Confidence Interval|Geometric Mean
2645169|NCT01713036|Primary|Area Under the Plasma Concentration Time Curve From Time Zero to the Last Sampling Time Point (AUC0-t) of [14C]‐Pimasertib Following Intravenous (IV) Administration on Day 1||Pre-dose, 0.5, 1, 1.5, 3, 5, 7, 9, 11, 15, 23, and 47 hours post [14C] intravenous pimasertib dose on Day 1|The Part A analysis set consists of all subjects who received the Part A medication, had absence of clinical trial protocol deviations affecting mass balance assessments, complied with trial medication with IMP intake for the complete Part A.|||hour*picogram equivalent/milliliter||95% Confidence Interval|Geometric Mean
2645170|NCT01712984|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Solicited injection site: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain and Pruritus Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis >100 mm. Grade 3 systemic reactions: Fever ≥39˚C; Headache, Malaise, Myalgia, and Shivering Significant preventing daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
2645171|NCT01712984|Secondary|Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroprotection was defined as titer ≥ 40 [1/dil] at baseline and 28 days after vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection against influenza virus antigens was assessed in the Per Protocol Analysis Set.|||Participants|||Number
2645172|NCT01712984|Secondary|Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers against the influenza virus antigens were assessed in the Per Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2645173|NCT01712984|Primary|Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route|Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroconversion was defined as titer< 10 (1/dil) on Day 0 and post injection titer ≥ 40 (1/dil) on Day 28, or titer ≥10 (1/dil) on Day 0 and a ≥4 fold increase in titer (1/dil) on Day 28).|Day 28 post-vaccination|Seroconversion to the influenza virus antigens were assessed in the Per Protocol Analysis Set.|||Participants|||Number
2645268|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - QTcF Interval at Week 10 (Visit 4)|The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.|Baseline and Week 10|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||msec||Full Range|Mean
2645175|NCT01712854|Secondary|Exercise Time in Steady State Exercise|Our secondary objective is to evaluate duration of steady state exercise and exercise capacity before and after treatment. Our secondary hypothesis is that decreases in dynamic hyperinflation during exercise will lead to improvements in dyspnea with exercise, and allow for increases in exercise capacity.|2 hours|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.||||||
2645176|NCT01712854|Primary|The Change in Dynamic Hyperinflation Measured by End Expiratory Volumes Recorded by Optoelectronic Plethysmography (OEP).|Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. We hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP.|2 hours|The principal investigator has left the institution. Attempts to contact the PI have been unsuccessful. Columbia will never have access to the data. Thus, data will not be analyzed. The only information available is the number of participants who started and completed the study, which was last reported to and approved by the IRB in February 2013.||||||
2645177|NCT01712776|Primary|Pain Scale on Numeric Rating Scale (NRS) ( 0 to 10)|NRS scale: 0-10 ; No pain (0) - (5) moderate pain - Worst pain (10)|Less than 10 minutes after stream application.|equal numbers in both groups by randomization to 50 in each group to look at NRS by change of 2 in NRS scale between the 2 groups|||units on a scale||Standard Deviation|Mean
2645178|NCT01712711|Primary|Liver Fat Content Change From Baseline to Six Weeks Post H.Pylori Treatment|Liver fat content was calculated by a valid formula. The formula is as the followings:Liver fat content (%) = 10 (-0.805 + 0.282 * metabolic syndrome (yes = 11 no = 0) + 0.078 * type 2 diabetes (yes =2 / no =0) + 0.525 * log fasting serum insulin (mU/L) + 0.521 * log fasting serum AST (U/L) - 0.454 * log (AST/ALT)|baseline and 6 weeks||||percentage of liver fat content||Standard Deviation|Mean
2645179|NCT01712685|Secondary|Kinetic (Ki) Rate Constant|Ki was assessed by the Patlak graphical analysis method which measures the uptake rate constant Ki.|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.||||1/Minutes||Standard Deviation|Mean
2645180|NCT01712685|Secondary|Time to Peak Activity Derived From Time Activity Curve (TAC)|The time to peak activity of radiotracer (tumor marker) uptake indicates the optimal time to image to obtain best tumor visibility.|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.||||Minutes||Standard Deviation|Mean
2645181|NCT01712685|Secondary|Distribution Volume Ratio (DVR) for the Primary Kidney Lesions|DVR of the lesions was measured by the Logan graphical analysis method.|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.||||Distribution volume ratio||Standard Deviation|Mean
2645182|NCT01712685|Secondary|Number of Participants With a Mutation of the Von Hippel-Lindau (VHL) Gene|Germline VHL mutation testing was performed using Clinical Laboratory Improvement Amendments (CLIA) certified laboratories.|21 days prior to enrollment until closure of the study, approximately 14 months.|5/11 participants had germline VHL testing with 4 having identifiable mutations of the VHL gene. 6/11 participants did not have germline VHL mutation testing due to low index of clinical suspicion although 2/6 had germline analysis for other gene mutations linked to familial renal cell carcinoma conditions.|||participants|||Number
2645183|NCT01712685|Secondary|Mean Standard Uptake Value (SUV) for Normal Kidney|Mean SUV for normal kidney was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour).|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.||||Standard uptake value (SUV||Full Range|Mean
2645184|NCT01712685|Secondary|Mean Standard Uptake Value (SUV) for Primary Clear Cell Renal Carcinoma (ccRCC)|Mean SUV for primary clear cell renal carcinoma was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour).|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.|Mean SUV for ccRCC after excluding Bosnial 3 Cyst (e.g. Bosnial 3 complex cyst) in one participant.|||Standard uptake value (SUV||Full Range|Mean
2645185|NCT01712685|Secondary|Mean Standard Uptake Value (SUV) for All Target Lesions|Mean SUV for all target lesions was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour).|Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging.||||Standard uptake value (SUV)||Full Range|Mean
2645186|NCT01712685|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|58 days||||participants|||Number
2645187|NCT01712685|Primary|Level of Uptake of 18F-VM4-037 in Tumor and Non Tumor Tissues, Calculated as Standardized Uptake Values (SUVs)|"The primary outcome measure will be assessed from quantitative measurements (e.g., correlate immunohistochemistry (IHC) results with standardized uptake values (SUVs) from positron emission tomography (PET) images) of the level of uptake of tumor and non tumor tissues into each target lesion, calculated as standardized uptake values. Normal renal parenchyma and muscle are both non-tumor tissue."|58 days||||Standardized uptake value||Standard Error|Mean
2645204|NCT01712490|Secondary|A+AVD: Cmax: Maximum Observed Serum Concentration for Brentuximab Vedotin Antibody-drug Conjugate (ADC) and Total Antibody (TAb)||Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The pharmacokinetic (PK) population included enrolled participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. The intensive PK (iPK) population was the subset of PK population. The iPK population where data at specified timepoints was available.|||microgram per milliliter (microgm/mL)||Standard Deviation|Geometric Mean
2645188|NCT01712516|Secondary|Secondary: Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score|The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.|BL, 12 weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
2645189|NCT01712516|Secondary|Secondary: Change From Baseline in Mean Daily Number of Puffs of Rescue Medication|Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours. A negative change from baseline indicates improvement.|BL, 12 weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.|||number of puffs||Standard Error|Least Squares Mean
2645190|NCT01712516|Secondary|Transitional Dyspnea Index (TDI) Focal Score|The Baseline Dyspnea Index (BDI) / TDI is an instrument used to assess a participant's level of dyspnea. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of ≥1 was defined as a clinically important improvement from baseline.|BL, 12 weeks|Full Analysis Set (FAS) The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 scores, were included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
2645191|NCT01712516|Secondary|Secondary: Change From Baseline in Standardized FEV1 AUC (0-4 h), FEV1 AUC (4-8h), FEV1 AUC (8-12h) and FEV1 AUC (0-12 h)|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.|BL, day 1, 12 weeks|Full Analysis Set: The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.|||Liters||Standard Error|Least Squares Mean
2645192|NCT01712516|Secondary|Change From Baseline in FVC|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FVC measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min; Day 2: 23h15min, 23h45min; Day 15: -45min, -15min, 1h; Day 29: -45 min, -15min, 1h; Day 57: -45min, -15min, 1h; day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h; day 86: 23h15min; 23h45min|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.|||Liters||Standard Error|Least Squares Mean
2645193|NCT01712516|Secondary|Change From Baseline in FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|BL, Day 1: 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h55 min; Day 2: 23h15min, 23h45min; Day 15: -45min, -15min, 1h; Day 29: -45 min, -15min, 1h; Day 57: -45min, -15min, 1h; day 85: -45min, -15min, 5min, 15min, 1h, 2h, 4h, 6h, 8h, 11h; day 86: 23h15min; 23h45min|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study medication. Participants, who has both baseline and post baseline values for a given time point, were included in the analysis for that time point.|||Liters||Standard Error|Least Squares Mean
2645194|NCT01712516|Secondary|Change From Baseline in Pre-dose Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Pre-dose trough FEV1 was analyzed using the same MMRM as specified for FEV1. Pre-dose trough FEV1 was defined as the mean of FEV1 at -45 min and -15 min before the morning dose. Since the time of evening dose of the previous day was not recorded at these visits, no time window was applied.|BL, day 85|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and week 12 values, were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2645195|NCT01712516|Secondary|Change From Baseline in Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Trough FEV1 was analyzed using the same MMRM as specified for FEV1. Trough FEV1 was defined as the mean of FEV1 at 23 h 15 min and 23 h 45 min after the morning dose of the previous day. Before the mean was calculated, a time window of 10 - 13 hours post-evening dose was applied to these 2 measurements. Recordings outside the time window were set to missing.|BL, day 2, day 86|Full Analysis Set (FAS): The FAS included all randomized participants who received at least one dose of study treatment. Participants, who had both baseline and post baseline values for a given time point, were included in the analysis for that time point.|||Liters||Standard Error|Least Squares Mean
2645196|NCT01712516|Secondary|Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score|"Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status."|12 weeks|Participants from the full analysis set, who had a SGRQ total score, were included in the analysis. The full analysis set included all randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2645197|NCT01712516|Secondary|Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score|"Participants reported change in health status by using the SGRQ. The SGRQ contains 50 items divided into 2 parts covering 3 aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts, which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score was calculated for each of these 3 subscales and a Total score was calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status. Missing week 12 data were imputed with Last Observation Carried Forward (LOCF) method but only if measured at day >= 29. A negative change from baseline indicates improvement."|BL, 12 Weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants missing week 12 data were not included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
2645198|NCT01712516|Primary|Primary: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h))|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction. Missing values of FEV1 AUC0-12 at Day 1 and Week 12 will not imputed. The trapezoidal rule was used to calculate FEV1 AUC and then normalized to the length of time.|baseline (BL), 12 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study treatment. Participants, who were missing day 1 and/or week 12 FEV1 AUC 0-12h measurements, were not included in the analysis.|||Liters||Standard Error|Least Squares Mean
2645199|NCT01712490|Secondary|Change From Baseline in Patient-Reported Outcome (PRO) Scores by mPFS Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) at EOT|EORTC QLQ-C30 included 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and global health status/QOL scale. It has 28 questions (4-point scale where 1=not at all [best] to 4=Very Much [worst]) and 2 questions (7-point scale where 1=very poor [worst] to 7= excellent [best]). Raw scores were converted into scale scores from 0 to 100. For functional scales and global health status/QOL scale, higher scores show better QOL; for symptom scales, lower scores show better QOL. mPFS was time from date of randomization to date of first of documentation of PD, death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for HL after completion of frontline therapy. PD is any new lesion or increase by >=50% of previously involved sites from nadir.|Baseline up to end of treatment (approximately 1 year)|The ITT population included all participants randomized to treatment.|||units on scale||Standard Deviation|Mean
2645200|NCT01712490|Secondary|A+AVD: Number of Participants With Antitherapeutic Antibody (ATA) and Neutralizing Antitherapeutic Antibody (nATA) Positive for Brentuximab Vedotin|The nATA positive was defined as positive ATA with neutralizing activity at any postbaseline visit.|Baseline up to end of treatment (approximately 1 year)|The safety population included all enrolled participants who received at least 1 dose of any study drug. The safety population-immunogenicity-evaluable participants where baseline and at least one postbaseline sample was available.|||participants|||Number
2645201|NCT01712490|Secondary|A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin MMAE||Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The PK population included enrolled participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. The iPK population was the subset of PK population. The iPK population where data at specified timepoints was available.|||day*nanogram per milliliter (day*ng/mL)||Standard Deviation|Mean
2645202|NCT01712490|Secondary|A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC and TAb||Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The PK population included enrolled participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. The iPK population was the subset of PK population. The iPK population where data at specified timepoints was available.|||day*microgram per milliliter (day*ug/mL)||Standard Deviation|Mean
2645203|NCT01712490|Secondary|A+AVD: Cmax: Maximum Observed Plasma Concentration for Brentuximab Vedotin Monomethyl Auristatin E (MMAE)||Cycle 1 Day 1 and Cycle 3 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose|The PK population included enrolled participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. The iPK population was the subset of PK population. The iPK population where data at specified timepoints was available.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2645269|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - QTcF Interval at Week 6 (Visit 3)|The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.|Baseline and Week 6|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||msec||Full Range|Mean
2645206|NCT01712490|Secondary|Complete Remission (CR) Per IRF Rate at the End of Frontline Therapy|CR rate at the end of frontline therapy per IRF was defined as the percentage of participants who achieved CR at the end of frontline therapy that is after completion of either randomized regimen or alternate frontline therapy as determined by an IRF. CR was defined as disappearance of all evidence of disease.|Baseline up to end of frontline therapy (approximately 4 years)|The ITT population included all participants randomized to treatment.|||percentage of participants|||Number
2645207|NCT01712490|Secondary|Percentage of Participants Not in CR Per IRF Who Received Subsequent Radiation After Completion of Frontline Therapy|CR was defined as disappearance of all evidence of disease as determined by an IRF.|Baseline up to end of frontline therapy (approximately 4 years)|The ITT population included all participants randomized to treatment.|||percentage of participants|||Number
2645208|NCT01712490|Secondary|Duration of Complete Remission (DOCR) Per IRF|DOCR per IRF in participants with CR was the time between first documentation of CR and PD as determined by an IRF. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease.|From first documentation of CR until PD (approximately 4 years)|The ITT population included all participants randomized to treatment. The ITT population where participants achieved CR.|||months||95% Confidence Interval|Median
2645209|NCT01712490|Secondary|Duration of Response (DOR) Per IRF|DOR per IRF in participants with response was the time between first documentation of response (PR or CR) and PD as determined by an IRF. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.|From first documented response until PD (approximately 4 years)|The ITT population included all participants randomized to treatment. The ITT population where participants achieved confirmed response of CR or PR.|||months||95% Confidence Interval|Median
2645210|NCT01712490|Secondary|Overall Response Rate (ORR) Per IRF|ORR per IRF was defined as the percentage of participants who achieved CR or partial remission (PR) at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by an IRF. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.|Baseline up to end of randomized regimen (approximately 1 year)|The ITT population included all participants randomized to treatment.|||percentage of participants|||Number
2645211|NCT01712490|Secondary|Disease-free Survival (DFS) Per IRF|DFS per IRF was defined as the time from CR to disease progression as determined by an IRF or to death from lymphoma or acute toxicity from treatment. CR was defined as disappearance of all evidence of disease.|From CR until PD or death (approximately up to 4 years)|The ITT included all participants randomized to treatment. The ITT population where participants achieved CR.|||months||95% Confidence Interval|Median
2645212|NCT01712490|Secondary|Event-free Survival (EFS) Per IRF|EFS was defined as the time from randomization until any cause of treatment failure: PD, premature discontinuation of randomized treatment for any reason, or death due to any cause, whichever occurs first. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir per IRF.|Baseline until PD or discontinuation of treatment or death, whichever occurs first (approximately up to 4 years)|The ITT population included all participants randomized to treatment.|||months||95% Confidence Interval|Median
2645213|NCT01712490|Secondary|Number of Participants With Abnormal Clinical Laboratory Values||Baseline up to 30 days after last dose of study drug (approximately 1 year)|The safety population included all enrolled participants who received at least 1 dose of any study drug.|||participants|||Number
2645214|NCT01712490|Secondary|Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)||Baseline up to 30 days after last dose of study drug (approximately 1 year)|The safety population included all enrolled participants who received at least 1 dose of any study drug.|||participants|||Number
2645215|NCT01712490|Secondary|Complete Remission (CR) Rate at the End of Randomized Regimen Per IRF|CR rate at the end of randomized regimen per investigator was defined as the percentage of participants who achieved CR at the end of treatment with randomized regimen (ABVD or A+AVD) as determined by IRF. CR was defined as disappearance of all evidence of disease.|Baseline up to end of randomized regimen (approximately 1 year)|The ITT population included all participants randomized to treatment.|||percentage of participants|||Number
2645216|NCT01712490|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death. Participants without documented death at the time of analysis were censored at the date last known to be alive.|Baseline until death (approximately up to 4 years)|The ITT population included all participants randomized to treatment.|||months||95% Confidence Interval|Median
2645217|NCT01712490|Primary|Modified Progression-free Survival (mPFS) Per Independent Review Facility (IRF)|mPFS was defined as the time from the date of randomization to the date of the first of documentation of progressive disease (PD), death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for Hodgkin lymphoma (HL) after completion of frontline therapy. PD was defined as any new lesion or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir. Frontline therapy is the part of standard set of treatments.|Baseline until PD or death or receipt of any subsequent anticancer therapy for HL after completion of frontline therapy (approximately up to 4 years)|The ITT population included all participants randomized to treatment.|||months||95% Confidence Interval|Median
2645218|NCT01712438|Other Pre-specified|The Occurrence of Any Adverse Event (AE)|The frequency of AEs, as monitored throughout the whole study by the number of patients with at least one adverse event occurrence.|5 years|Of the 110 patients enrolled in the study, 2 were excluded because they had no treatment with Human-cl rhFVIII leaving 108 patients in the safety (SAF) and intent-to-treat (ITT) population.|||Participants|||Count of Participants
2645219|NCT01712438|Secondary|Efficacy of Human-cl rhFVIII for Surgical Prophylaxis|An overall efficacy assessment to assess the efficacy of human-cl rhFVIII in surgical prophylaxis of minor and major surgeries. The efficacy assessment was analyzed using a four-point scale (excellent, good, moderate, none).|Maximum 5 years (100 exposure days)|The analysis population includes 24 patients that received Human-cl rhFVIII for surgical prophylaxis during a total of 26 surgeries (SURG population). Of these, 13 patients had minor surgeries and 11 patients had major surgeries. Of the total 26 surgeries, 21 had an overall efficacy assessment (an assessment was not performed for 5 surgeries).|||Number of surgeries|Number of surgeries||Count of Units
2645220|NCT01712438|Secondary|Efficacy of Human-cl rhFVIII for the Treatment of Bleeds|A personal efficacy assessment to assess the efficacy of Human-cl rhFVIII for the on-demand treatment of bleeding episodes. Efficacy was assessed using a four-point scale (excellent, good, moderate, none).|Maximum 5 years (100 exposure days)|The analysis population includes patients (n=94) who received Human-cl rhFVIII for on-demand treatment of BEs (BLEED population).|||Number of Bleeding Events|Number of Bleeding Events||Count of Units
2645221|NCT01712438|Secondary|Frequency of Spontaneous Break-through Bleeds|The annualized bleeding rate (ABR) was calculated during inhibitor-free periods for spontaneous bleeding events (BEs) during prophylactic treatment with Human cl rhFVIII|Maximum 5 years (100 exposure days)|The analysis population includes all patients who received at least one prophylactic treatment with Human-cl rhFVIII (PROPH population; n=103). Of all patients in the PROPH population, data was available on spontaneous break-through bleeds for 102 patients.|||No. BEs per duration (year) (ABR)||95% Confidence Interval|Mean
2645222|NCT01712438|Primary|Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors|"The number of patients developing FVIII inhibitors was observed during the observation period by assessing inhibitor development using the modified Bethesda assay (Nijmegen modification). The definitions for thresholds were ≥0.6 to <5 BU/mL for a low titre inhibitor and ≥5 BU/mL for a high-titre inhibitor."|maximum 5 years (100 exposure days)|The analysis was performed for the SAF/ITT population which includes all patients who had data collected post-treatment with Human-cl rhFVIII (n=108). Of the 108 patients, 105 patients had at least one inhibitor test after exposure day (ED) 1.|||Participants|||Count of Participants
2645223|NCT01712399|Primary|Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)|DLCO is a pulmonary function testing that measures partial pressure difference between inspired and expired carbon monoxide.|From Week 12 to Week 156 at specified time points|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.|||(mL/min/mmHg)||Standard Deviation|Mean
2645224|NCT01712399|Primary|Oxygen Saturation Levels by Pulse Oximetry|Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.|From Week 0 to Week 132 at specified time points|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.|||Percent saturation||Standard Error|Mean
2645225|NCT01712399|Primary|Number of Participants With Clinically Meaningful Change in Borg Dyspnea Score Considered as an AE|Borg dyspnea score was a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The score ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing.|From Week 0 to Week 132 at specified time points|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.|||Participants|||Number
2645226|NCT01712399|Primary|Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values|Pulmonary function testing was performed by spirometry to assess forced vital capacity (FVC). FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The percentage of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as =<15% reduction from baseline, >15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant.|From Week 24 to Week 156 at specified time points|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.|||Participants|||Number
2645227|NCT01712399|Primary|Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values|Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 6 seconds (FEV6). FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. The percentage of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as =<15% reduction from baseline, >15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant.|From Week 24 to Week 130 at specified time points|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.|||Participants|||Number
2645228|NCT01712399|Primary|Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values|Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.The percentage (%) of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as less than or equal to (=<)15% reduction from baseline, greater than (>)15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant.|From Week 24 to Week 130 at specified time points|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points.|||Participants|||Number
2645229|NCT01712399|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs|The 12-lead ECG data were summarized and evaluated. TEAEs related to abnormal ECG findings were recorded and reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.|From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.|||Participants|||Number
2645230|NCT01712399|Primary|Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital sign abnormalities recorded as TEAEs were reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.|From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.|||Participants|||Number
2645231|NCT01712399|Primary|Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)|Laboratory parameters included hematology, serum chemistry and urinalysis recorded as TEAEs. Clinical laboratory abnormalities recorded as TEAEs were reported.TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.|From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years)|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.|||Participants|||Number
2645232|NCT01712399|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg.|From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)|The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.|||Participants|||Number
2645233|NCT01712360|Secondary|Efficacy Variables|"Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).~Efficacy variables to be analyzed:~- Subject satisfaction"|Day 28|Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available.|||Percentage (%) of subjects|||Number
2645234|NCT01712360|Primary|Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose|"Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:~- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject after single dose.~Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:~- Maximum observed plasma concentration (Cmax): the highest plasma concentration in each subject at steady state (SS)."|Day 1 and Day 14|Pharmacokinetic analysis set (PKS), defined as the subset of subjects in safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2645235|NCT01712360|Secondary|Efficacy Variables|"Efficacy variables to be analyzed after 2 weeks of once daily application of both products (NAFT-500 or NAFT-600).~Efficacy variables to be analyzed:~Complete cure~Treatment effectiveness~Mycological cure~Clinical success~Clinical cure"|Day 28|Full analysis set, defined as subset of subjects in the safety evaluation set (SES) for whom any efficacy variable is available.|||Percentage (%) of subjects (90% CI)||90% Confidence Interval|Number
2645236|NCT01712360|Primary|Naftifine Hydrochloride Pharmacokinetics Variables, Single and Multiple Dose|"Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed:~- Partial area under the plasma concentration-time curve (0-24 hours postdose) (AUC), as calculated using the linear trapezoid rule.~Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed:~- Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state (SS). AUCτ,ss= Area under the concentration curve within a dosing interval (τ = 24 hours) at steady state"|Day 1 and Day 14|Pharmacokinetic analysis set (PKS), defined as the subset of subjects in the safety evaluation set (SES) with evaluable pharmacokinetic (PK) samples.|||h*pg/mL||Geometric Coefficient of Variation|Geometric Mean
2645237|NCT01712334|Primary|Safety: Number of Participants With Adverse Events During Each Treatment Period|An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.|4 Weeks|Safety population included all randomized participants who received treatment.|||participants|||Number
2645238|NCT01712334|Primary|Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)|Spirometry was performed according to American Thoracic Society standards. FEV1 is the amount of air that is forced out of the lungs in one second and was measured at the end of each 2-week treatment period. The percent predicted FEV1 was calculated as: Percent predicted FEV1 =FEV1 (L) / Predicted FEV1 (L) ×100.|At the end of each 2-week treatment period|Modified Intent-to-Treat (mITT) population included all randomized participants with baseline and endpoint FEV1 values for both treatment periods.|||percent predicted||Standard Deviation|Mean
2645239|NCT01712256|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|To evaluate the safety and tolerability of re-boosting with Vacc-4x by number of participants with Adverse Events|37 weeks||||participants|||Number
2645240|NCT01712256|Secondary|Delayed Type Hypersensitivity Test (DTH), Positive Responses for Erythema|The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.|4 Weeks|"The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).~Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study."|||participants|||Number
2645241|NCT01712256|Secondary|Delayed Type Hypersensitivity Test (DTH), Positive Responses for Induration|The proportion of subjects who show Delayed Type Hypersensitivity (DTH) during the treatment phase.|4 weeks|"The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).~Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study."|||participants|||Number
2645242|NCT01712256|Secondary|Vacc-4x Effect on Immune Response Measured as CD8 Count|Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1|36 weeks|"The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).~Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study."|||cells/micro liter||Standard Deviation|Mean
2646243|NCT01705080|Secondary|Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 24 Months||Baseline and 24 months||||mL/min per 1.73 m^2||Standard Deviation|Mean
2645243|NCT01712256|Secondary|Vacc-4x Effect on Immune Response Measured as CD4 Count|Effect of Re-boost with Vacc-4x on immune response obtained following immunization with Vacc-4x in Study CT-BI Vacc-4x 2007/1|36 weeks|"The ITT includes 30 subjects (3 did not receive ART from Scr. through Week 12) and the PP includes 27 (an additional 3 did not discontinue ART at Week 12).~Due to the influence of ART on efficacy endpoints, certain subjects or part of their data were excluded from the full ITT and PP, based on when they were on or off ART during the study."|||cells/micro liter||Standard Deviation|Mean
2645244|NCT01712256|Primary|Vacc-4x Effect on Viral Load Set-point|Viral load (VL) set point in the present re-boost study was compared with VL set point in the 2007/1 study.|37 weeks|In the ITT population there were 20 evaluable subjects out of 30 (3 subjects did not receive ART from Screening through Week 12) and in the PP population there were 18 evaluable subjects out of 27 (an additional 3 subjects did not discontinue ART at Week 12).|||Copies/mL||Standard Deviation|Mean
2645245|NCT01712230|Secondary|Total Fat Free Mass|Total Fat Free Mass as measured by DXA|Change over 6 months||||kg||Standard Error|Mean
2645246|NCT01712230|Secondary|Total Fat Mass|Total Fat mass as measured by DXA|Change over 6 months||||kg||Standard Error|Mean
2645247|NCT01712230|Primary|Change in Physical Activity Energy Expenditure (PAEE)|PAEE will be calculated as: TEE - REE - TEF, where TEE is total energy expenditure (measured by doubly-labeled water), REE is resting energy expenditure (measured by indirect calorimetry), and TEF is the thermic effect of feeding (estimated using a constant).|Change from baseline to 6 months|Placebo: One participant dropped because they got a new job. GnRH agonist+exercise: One participant dropped because of a health problem unrelated to the study. Results from five participants were not included in the analysis because they did not meet the exercise compliance threshold (completed <70% of exercise sessions).|||kcal/day||Standard Error|Mean
2645248|NCT01712204|Primary|Number of Gout Flares Per Subject||16 weeks||||flares||95% Confidence Interval|Least Squares Mean
2645249|NCT01712178|Secondary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|"The Visual Analogue Scale (VAS) consisted of a horizontal 100 mm line, with 0 representing no pain and 100 representing worst possible pain. Participants placed a mark on the line representing their current level of pain immediately after injections on Day 1 of the study."|Immediately after injections on Day 1||||Millimeters||Standard Deviation|Mean
2645250|NCT01712178|Secondary|Number of Participants With Adverse Events|An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. See the Reported Adverse Events Section for more details.|From time of informed consent to 70 days following the last dose of study drug||||participants|||Number
2645251|NCT01712178|Secondary|Percentage of Participants Positive for Anti-adalimumab Antibody|Percentage of participants with anti-adalimumab antibody|Measured through Week 24||||Percentage of participants|||Number
2645252|NCT01712178|Secondary|Mean Short Form-36 (SF-36) Physical Component Summary Scores and Mental Component Summary Scores at Weeks 12 and 24|The Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 (maximum disability) - 100 (no disability). The standard recall period is four weeks.|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.|||units on a scale||Standard Error|Least Squares Mean
2645253|NCT01712178|Secondary|Mean Health Assessment Questionnaire (HAQ-DI) Scores at Weeks 12 and 24|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5.|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.|||units on a scale||Standard Error|Least Squares Mean
2645254|NCT01712178|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 12 and 24|"American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:~≥ 50% improvement in tender joint count;~≥ 50% improvement in swollen joint count; and~≥ 50% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))"|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.|||percentage of participants|||Number
2645270|NCT01712074|Other Pre-specified|Proportion of Participants With QRS Complex Abnormalities of Potential Clinical Concern|Proportion (%) of participants with QRS Complex abnormalities meeting categorical criteria over the 12 week double blind treatment period. The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization). Participants with post-baseline QRS complex absolute value>=100 msec , a QRS complex increase of >=25% (for participants with a baseline value>=100 msec), or with an increase >=50% (for participants with a baseline value<100 msec) were counted.|Week 4 to Week 16|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||Percentage of participants|||Number
2645255|NCT01712178|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 12 and 24|"American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met:~≥ 20% improvement in tender joint count;~≥ 20% improvement in swollen joint count; and~≥ 20% improvement in at least 3 of the 5 following parameters:~Physician global assessment of disease activity~Patient global assessment of disease activity~Patient assessment of pain~Disability Index of the Health Assessment Questionnaire~CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))"|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.|||percentage of participants|||Number
2645256|NCT01712178|Primary|Mean Disease Activity Scores (DAS28) at Weeks 12 and 24|The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Measured at Weeks 12 and 24|All available data were included. If a subject did not have a value for a given time of evaluation, but did have a value at times previous to this after the study drug treatment began, the last available value was used to replace the missing value.|||units on a scale||Standard Error|Least Squares Mean
2645257|NCT01712178|Primary|Serum Concentrations of Adalimumab at Weeks 12 and 24|Blood samples for adalimumab analysis were collected by venipuncture and serum concentrations of adalimumab were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method.|Measured at Weeks 12 and 24|Data from participants receiving the new formulation of adalimumab were analyzed for 46 and 47 participants, respectively, at weeks 12 and 24. Data for the participants receiving the current formulation of adalimumab were analyzed for 43 participants at week 12 and 41 participants at week 24.|||µg/mL||Standard Deviation|Mean
2645258|NCT01712074|Other Pre-specified|Participants in Each Category of C-CASA Mapped From the C-SSRS Responses|"Participants in each category of the Columbia Classification Algorithm of Suicide Assessment (C-CASA) mapped from the Columbia-Suicide Severity Rating Scale (C-SSRS) responses were reported.~C-CASA Event Code: <1> Completed suicide; <2> Suicide attempt; <3> Preparatory acts towards imminent suicidal behavior; <4> Suicidal Ideation; <7> Self-injurious behavior, no suicidal intent.~The suicidality assessments were performed at Screening, Week 0 (Visit 1), Week 4 (Visit 2), Week 6, (Visit 3), Week 10 (Visit 4), Week 16 (Visit 5), and Week 18 (Visit 6).~Only participants falling any category of C-CASA events were listed below."|From Screening to Week 18/Early Termination|All participants screened and assigned|||Participants|||Number
2645259|NCT01712074|Other Pre-specified|Proportion of Participants With Post-Baseline Vital Signs Abnormalities of Potential Clinical Concern|Proportion (%) of participants with vital signs abnormalities (absolute and change from baseline) meeting categorical criteria over the 12-week double blind treatment period were counted. Vital signs data included blood pressure (BP) and pulse rate.|Week 4 to Week 16|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||Percentage of Participants|||Number
2645260|NCT01712074|Other Pre-specified|Pulse Rate Changes From Baseline - Week 16/Early Termination (Visit 5)|The pulse rate changes from baseline at Week 16/Early Termination (Visit 5) including supine pulse rate, and standing pulse rate.|Baseline and Week 16/Early Termination|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||bpm||Full Range|Mean
2645261|NCT01712074|Other Pre-specified|BP Changes From Baseline - Week 16/Early Termination (Visit 5)|The BP changes from baseline at Week 16/Early Termination (Visit 5) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.|Baseline and Week 16/Early Termination|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||mmHg||Full Range|Mean
2645262|NCT01712074|Other Pre-specified|Pulse Rate Changes From Baseline - Week 10 (Visit 4)|The pulse rate changes from baseline at Week 10 (Visit 4) including supine pulse rate, and standing pulse rate.|Baseline and Week 10|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||bpm||Full Range|Mean
2645263|NCT01712074|Other Pre-specified|BP Changes From Baseline - Week 10 (Visit 4)|The BP changes from baseline at Week 10 (Visit 4) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.|Baseline and Week 10|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||mmHg||Full Range|Mean
2645264|NCT01712074|Other Pre-specified|Pulse Rate Changes From Baseline - Week 6 (Visit 3)|The pulse rate changes from baseline at Week 6 (Visit 3) including supine pulse rate, and standing pulse rate.|Baseline and Week 6|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||beats per minute (bpm)||Full Range|Mean
2645265|NCT01712074|Other Pre-specified|Blood Pressure (BP) Changes From Baseline - Week 6 (Visit 3)|The BP changes from baseline at Week 6 (Visit 3) including supine systolic BP, standing systolic BP, standing systolic BP, supine diastolic BP, standing diastolic BP.|Baseline and Week 6|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||millimeters of mercury (mm Hg)||Full Range|Mean
2645266|NCT01712074|Other Pre-specified|Proportion of Participants With QTcF Interval Abnormalities of Potential Clinical Concern|"Proportion (%) of participants with QTcF Interval abnormalities meeting categorical criteria over the 12-week double blind treatment period. The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.~Participants with a post-baseline QTcF absolute value of 450 - <480, 480 - <500, or >=500 mec, or with a post-baseline QTcF increase of 30 - <60 or >=60 msec were counted."|Week 4 to Week 16|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||Percentage of Participants|||Number
2645267|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - QTcF Interval at Week 16/Early Termination (Visit 5)|The QTcF interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle, which is corrected for heart rate using Fridericia's formula.|Baseline and Week 16/Early Termination|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||msec||Full Range|Mean
2645271|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - QRS Complex at Week 16/Early Termination (Visit 5)|The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.|Baseline and Week 16/Early Termination|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||msec||Full Range|Mean
2645272|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - QRS Complex at Week 10 (Visit 4)|The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.|Baseline and Week 10|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||msec||Full Range|Mean
2645273|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - QRS Complex at Week 6 (Visit 3)|The QRS complex is the combination of the Q wave, R wave and S wave, representing ventricular depolarization.|Baseline and Week 6|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||msec||Full Range|Mean
2645274|NCT01712074|Other Pre-specified|Percentage of Participant With PR Interval Abnormalities of Potential Clinical Concern|Proportion (%) of participants with PR Interval abnormalities meeting categorical criteria over the 12 week double blind treatment period. The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization). Participants with post-baseline PR absolute value>=300 msec , a PR increase of >=25% (for participants with a baseline value>=200 msec), or with an increase >=50% (for participants with a baseline value<200 msec) were counted.|Week 4 to Week 16|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||Percentage of Participants|||Number
2645275|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - PR Interval at Week 16/Early Termination (Visit 5)|The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).|Baseline and Week 16/Early Termination|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||msec||Full Range|Mean
2645276|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - PR Interval at Week 10 (Visit 4)|The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).|Baseline and Week 10|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||msec||Full Range|Mean
2645277|NCT01712074|Other Pre-specified|Selected ECG Change From Baseline - PR Interval at Week 6 (Visit 3)|The PR interval is the time from the onset of the P wave to the start of the QRS complex (the combination of the Q wave, R wave and S wave, representing ventricular depolarization).|Baseline and Week 6|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||milliseconds (msec)||Full Range|Mean
2645278|NCT01712074|Other Pre-specified|Proportion of Participants With Laboratory Abnormalities of Potential Clinical Concern During Double Blind Period|"Proportion (%) of participants with laboratory abnormalities (without regard to baseline abnormalities) of potential clinical concern over the 12-week double blind treatment period.~The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein/albumin, hemoglobin/blood, ketones/acetone, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (only at screening or needed: urine drug screen, thyroid panel, Vitamin B12, methylmalonic acid, folate and Hemoglobin A1)."|Week 4 to Week 16|All participants who received any treatment during Week 4 (Visit 2) to Week 16 (Visit 5)|||Percentage of Participants|||Number
2645279|NCT01712074|Other Pre-specified|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation|Proportion of participants with TEAEs leading to discontinuation over the 12-week double blind treatment period and washout. Adverse events (AEs) occurring following start of treatment or increasing in severity were counted as treatment emergent|Week 4 to Week 18|All participants who received any treatment during double blind period|||Percentage of Participants|||Number
2645280|NCT01712074|Secondary|Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 16 (Visit 5)|The NPI evaluates both frequency and severity of 12 neuropsychiatric disturbances including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, as well as appetite/eating. The NPI total score (for 12 behavioral domains) is calculated as the product of frequency and severity for each domain, and ranges from 0 to 144. An increase in score indicates a worsening of symptoms.|Baseline and Week 16|The FAS is defined as all participants who are randomized. The FAS was the primary analysis set for efficacy data.|||scores on a scale||Standard Error|Least Squares Mean
2645281|NCT01712074|Primary|Change From Baseline in ADAS-cog13 Total Score at Week 16|ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening.|Baseline and Week 16|The Full Analysis Set (FAS) is defined as all participants who were randomized. The FAS was the primary analysis set for efficacy data.|||scores on a scale||Standard Error|Least Squares Mean
2645282|NCT01712061|Other Pre-specified|Number of Participants With Increased Fasting Blood Glucose||Baseline up to Week 16 (follow-up visit)|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; number of participants analyzed (N) is number of evaluable participants for this outcome measure.|||participants|||Number
2645305|NCT01711918|Secondary|Improvement of Premature Abdominal Fullness After Meals Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)||||Participants|||Count of Participants
2646244|NCT01705080|Secondary|Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 12 Months||Baseline and 12 months||||mL/min per 1.73m^2||Standard Deviation|Mean
2645283|NCT01712061|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious AEs.|Baseline up to 28 days after last study drug administration|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication.|||participants|||Number
2645284|NCT01712061|Other Pre-specified|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|Criteria for potentially clinically important ECG values were defined as: PR interval >=300 milliseconds (msec) or >=25%/50% increase when baseline is >200 msec and ≥50% increase when baseline is less than or equal to (<=)200 msec; QRS interval >=140 msec or >=50% increase from baseline (IFB); QTc >=450 msec or >=30 msec increase; corrected QT interval using Fridericia's formula (QTcF) >=450 msec or >=30 msec increase.|Baseline, Weeks 1, 4 and 12|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.|||participants|||Number
2645285|NCT01712061|Other Pre-specified|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed for abnormalities at any time point mentioned in the timeframe: clinical chemistry (sodium, potassium, chloride, bicarbonate, phosphate, glucose, blood urea nitrogen [BUN], creatinine, albumin, calcium, bilirubin [total, direct, and indirect], gamma-glutamyl transferase [GGT], alanine aminotransferase [ALT], aspartate aminotransferase [AST], lactic dehydrogenase [LDH], alkaline phosphatase, creatine phosphokinase [CPK], uric acid, amylase and lipase); hematology (hemoglobin, hematocrit, red blood cell [RBC] count, white blood cell [WBC] count with differential, and platelet count); FSH (for postmenopausal women who had been amenorrheic for less than 2 years prior to screening).|Baseline up to Week 16 (follow-up visit)|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; number of participants analyzed (N) is number of evaluable participants for this outcome measure.|||participants|||Number
2645286|NCT01712061|Other Pre-specified|Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16||Baseline, Weeks 1, 4, 8, 12 and 16|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.|||kilograms (kg)||Standard Deviation|Mean
2645287|NCT01712061|Other Pre-specified|Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16||Baseline, Weeks 1, 4, 8, 12 and 16|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.|||beats per minute (bpm)||Standard Deviation|Mean
2645288|NCT01712061|Other Pre-specified|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16||Baseline, Weeks 1, 4, 8, 12 and 16|The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.|||millimeters of mercury (mm Hg)||Standard Deviation|Mean
2645289|NCT01712061|Secondary|Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12||1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12|The PK Concentration Analysis Set is defined as all participants in the FAS for whom a PK sample was obtained and analyzed; n=number of participants analyzed in respective arms for category.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2645290|NCT01712061|Secondary|Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of HbA1c increases in a predictable way.|Baseline, Weeks 4, 8, 12 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.|||percent||Standard Deviation|Mean
2645291|NCT01712061|Secondary|Change From Baseline in Serum Cystatin C at Weeks 12 and 16|Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise.|Baseline, Week 12, and Week 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.|||mg/dL||Standard Deviation|Mean
2645292|NCT01712061|Secondary|Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week 1, 4, 8, 12 or 16 minus baseline level where higher scores represented decreased kidney function.|Baseline, Week 1, 4, 8, 12 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2645293|NCT01712061|Secondary|Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16|Serum cystatin C may be a more reliable endogenous marker of GFR than serum creatinine. eGFR was calculated using the Cystatin Formula and normalized to 1.73 m^2 body surface area.|Baseline, Week 12, and Week 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.|||mL/min/1.73m^2||Standard Deviation|Mean
2645306|NCT01711918|Secondary|Improvement of Abdominal Bloating or Distention Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)||||Participants|||Count of Participants
2645294|NCT01712061|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16|eGFR was calculated using the MDRD equation and normalized to 1.73 m^2 body surface area. Age and corresponding creatinine at each visit (Weeks 1, 4, 8, 12 and 16) were used to calculate GFR|Baseline, Week 1, 4, 8, 12 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.|||mL/min/1.73m^2||Standard Deviation|Mean
2645295|NCT01712061|Secondary|Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16|The presence of protein in the urine (proteinuria) often implies kidney disease. Protein and creatinine concentrations were obtained from spot urine samples.|Baseline, Weeks 4, 8, 12 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.|||mg/mmolCr||Geometric Coefficient of Variation|Geometric Mean
2645296|NCT01712061|Secondary|Change From Baseline in UACR at Weeks 4, 8 and 16|The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.|Baseline, Weeks 4, 8 and 16|The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.|||mg/millimolar creatinine (mmolCr)||Geometric Coefficient of Variation|Geometric Mean
2645297|NCT01712061|Primary|Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12|The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.|Baseline and Week 12|The Full Analysis Set (FAS) was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.|||percent (%)||95% Confidence Interval|Mean
2645298|NCT01712009|Secondary|Number of Participants With Adverse Events (AEs)|"Severity was graded using CTCAE version 3. A serious adverse event (SAE) is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal; • life threatening; • requires in-patient hospitalization or prolongation of existing hospitalization; • results in persistent or significant disability/incapacity; • congenital anomaly/birth defect; • other medically important serious event.~The investigator assessed each adverse event for relatedness to investigational product(s) or other protocol-required therapies."|From first dose of investigational product (IP, naproxen or loratidine) or first dose of pegfilgrastim (Peg), whichever occurred first, until 30 days after last dose, up to 24 weeks.|Safety analysis set included all participants who received primary prophylaxis with pegfilgrastim according to the prophylactic medication actually received. Participants in the Naproxen or Loratadine groups who did not receive naproxen or loratadine are analyzed in the No Prophylaxis group for safety analyses.|||participants|||Number
2645299|NCT01712009|Secondary|Area Under the Curve (AUC) for Patient-reported Bone Pain|Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from day 1 to 5 for each cycle. The AUC across cycles is the average of AUCs across the cycle.|Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)|"Full analysis set; all missing values of patient-reported bone pain within any cycle were imputed. n indicates the number of participants who entered each cycle."|||units on a scale * days||Standard Error|Least Squares Mean
2645300|NCT01712009|Secondary|Maximum Patient-reported Bone Pain by Cycle and Across Cycles|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Maximum patient-reported bone pain is the maximum of each participant's bone pain values across survey Days 1-5 within each cycle. Across all cycles the maximum is the maximum of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An ANOVA model with treatment as explanatory term was used.|Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)|"Full analysis set; all missing values of patient-reported bone pain within any cycle were imputed. n indicates the number of participants who entered each cycle."|||units on a scale||Standard Error|Least Squares Mean
2645301|NCT01712009|Secondary|Mean Patient-reported Bone Pain by Cycle and Across Cycles|Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Mean patient-reported bone pain values are the average of each participant's bone pain values across survey days 1-5 within each cycle. Across all cycles the mean is the average of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An analysis of variance (ANOVA) model with treatment as explanatory term was used.|Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)|"Full analysis set; all missing values of patient-reported bone pain within any cycle were imputed. n indicates the number of participants who entered each cycle."|||units on a scale||Standard Error|Least Squares Mean
2645302|NCT01712009|Secondary|Percentage of Participants With Severe Bone Pain by Cycle and Across Cycles|Bone pain data were captured as part of standard adverse event reporting. Severe bone pain is defined as grade 3 or 4 according to common terminology criteria for adverse events (CTCAE) version 3 grading criteria: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Life-threatening or disabling.|Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)|"Full analysis set; n indicates the number of participants who entered each cycle."|||percentage of participants||95% Confidence Interval|Number
2645303|NCT01712009|Secondary|Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles|Bone pain data were captured as part of standard adverse event (AE) reporting.|Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)|"Full analysis set; n indicates the number of participants who entered each cycle."|||percentage of participants||95% Confidence Interval|Number
2645304|NCT01712009|Primary|Percentage of Participants With Bone Pain (All Grades) in Cycle 1|Bone pain data were captured as part of standard adverse event (AE) reporting.|Cycle 1 (approximately 4 weeks, depending on the chemotherapy dosing interval)|Full anlysis set|||percentage of participants||95% Confidence Interval|Number
2645307|NCT01711918|Secondary|Improvement of Vomiting Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)||||Participants|||Count of Participants
2645308|NCT01711918|Secondary|Improvement of Nausea Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)||||Participants|||Count of Participants
2645309|NCT01711918|Primary|Improvement of Overall Symptoms Based on Likert Scale|A subject will be considered a responder, if they report on a 6 point Likert scale that when compared to baseline, their symptoms are either 'somewhat better or markedly better'.|Baseline and End of study (2 years or last visit if patient withdraws)||||Participants|||Count of Participants
2645310|NCT01711866|Secondary|Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit|"The PGIC is a 7-point categorical rating scale in which the subject rates the changes in functioning over time as follows:~1 = Very much improved~2 = Much improved~3 = Minimally improved~4 = No change~5 = Minimally worse~6 = Much worse~7 = Very much worse."|Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 35.|||participants|||Number
2645311|NCT01711866|Primary|Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit|"The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows:~0 = Side effects not assessable~1 = No side effects~2 = Side effects do not significantly interfere with subject's functioning~3 = Side effects significantly interfere with the subject's functioning~4 = Side effects outweigh therapeutic efficacy."|Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit|All 87 subjects of the Safety Set are included in the analysis of this outcome measure. Last Observation Carried Forward (LOCF) was used as a method of imputation for missing observations.|||participants|||Number
2645312|NCT01711853|Primary|AUCtau,ss|"Area under the plasma concentration-time curve of the total dabigatran at steady state over a uniform dosing interval tau was measured.~The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration."|-0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h|PKS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2645313|NCT01711853|Primary|Cmax,ss|"Maximum concentration of Dabigatran etexilate in plasma at steady state was measured.~The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration."|-0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h|Pharmacokinetic set (PKS) which included all treated subjects that provided at least 1 observation for at least 1 primary pharmacokinetic endpoint without important protocol violations with respect to the evaluation of the pharmacokinetic endpoints and with predose values not greater than 5% of Cmax.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2645314|NCT01711736|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 - Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
2645315|NCT01711736|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 28-day (Days 0-27) post-vaccination period.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
2645316|NCT01711736|Secondary|Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject.|During the entire study period (Day 0 to Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
2645317|NCT01711736|Secondary|Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)|MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).|During the entire study period (Day 0 to Day 180)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
2645318|NCT01711736|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Fever|Any fever was defined as any fever ≥38.0 °C irrespective of intensity and relationship to vaccination. Related was defined as symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
2645319|NCT01711736|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains.|MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)|28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2645320|NCT01711736|Secondary|Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.|A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)|At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||subjects|||Number
2645321|NCT01711736|Secondary|Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Fluarix Vaccine|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the Fluarix Group.|At Day 28 for primed subjects and at Day 56 for unprimed subjects|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||subjects|||Number
2645322|NCT01711736|Secondary|Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains|HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)|At Day 0 (for all subjects) and 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2645323|NCT01711736|Primary|Number of Subjects Reporting Any, Grade 3 and Related Fever|Any fever was defined as any fever ≥38.0 degrees Celsius (°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
2645324|NCT01711736|Primary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever).|Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
2645325|NCT01711736|Primary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 7-day (Days 0-6) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.|||subjects|||Number
2645326|NCT01711736|Primary|Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Quadrivalent Influenza GSK2282512A Vaccine.|A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the GSK2282512A Group.|At Day 28 for primed subjects and at Day 56 for unprimed subjects|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||subjects|||Number
2645327|NCT01711645|Secondary|Kinetics of the ELISA IgG Antibody Decline in Breast Milk Expressed in EU/ml.|Breast milk samples were collected from participants for evaluation of PT and FHA secretory IgA (sIgA) by ELISA. The protocol defined kinetics as assessment at each post-vaccination timepoint of the geometric mean fold rise, defined as the geometric mean of participants' fold rise in post vaccination sIgA relative to the pre-vaccination sIgA.|Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination|Only 4 participants were able to provide a breast milk (colostrum) sample at baseline and post vaccination samples had no detectable titer, resulting in a fold-rise analysis being uninterpretable; therefore, this analysis was not conducted.||||||
2645328|NCT01711645|Secondary|Geometric Mean Fold Rise in Antibody Concentrations Assessed by ELISA in Breast Milk by Study Day|Breast milk samples were collected from participants for evaluation of secretory IgA (sIgA) by ELISA. Geometric mean fold rise was defined as the geometric mean of participants' fold rise in post vaccination sIgA relative to the pre-vaccination sIgA.|Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination|Only 4 participants were able to provide a breast milk (colostrum) sample at baseline and post vaccination samples had no detectable titer, resulting in a fold-rise analysis being uninterpretable; therefore, this analysis was not conducted.||||||
2645329|NCT01711645|Secondary|Proportion of Participants With 4-fold Rise in Antibody in Breast Milk by Study Day.|Breast milk samples were collected from participants for evaluation of PT and FHA secretory IgA (sIgA) by ELISA. The lower limit of quantification (LLOQ) for the assay was 10 EU/mL. A 4-fold rise in concentration from prior to vaccination was defined as a post-vaccination sIgA concentration greater than or equal to 40 EU/mL for participants with baseline sIgA concentrations less than the LLOQ, or 4 times the baseline sIgA concentration for baseline sIgA concentrations greater than the LLOQ.|Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination|Only 4 participants were able to provide a breast milk (colostrum) sample at baseline and post vaccination samples had no detectable titer, resulting in a fold-rise analysis being uninterpretable; therefore, this analysis was not conducted.||||||
2645330|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to PRN and FIM by Study Day.|Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the PRN and FIM antigen by ELISA. Available data at the timepoint were to be summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. The lower limit of quantitation (LLOQ) of the assay was 10 EU/mL.|Baseline (prior to vaccination), Week 2, Week 6 and Month 6 post vaccination|The laboratory staff was not successful in attempts to conduct the ELISA assay against the pertactin and fimbrae antigens with the breast milk samples.||||||
2645331|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to FHA at Month 6.|Breast milk was collected from participants at 6 months post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.|6 months post vaccination|All participants providing a breast milk sample at the timepoint are included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
2645332|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to FHA at Week 6.|Breast milk was collected from participants at 6 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the FHA at this timepoint, all participants had a concentration of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.|6 weeks post vaccination|All participants providing a breast milk sample at the timepoint are included in the analysis population.|||EU/mL||Full Range|Geometric Mean
2645333|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to FHA at Week 2.|Breast milk was collected from participants at 2 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.|2 weeks post vaccination|All participants providing a breast milk sample at the timepoint are included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
2645334|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to FHA at Baseline.|Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.|Baseline (prior to vaccination)|All participants providing a breast milk (colostrum) sample at the timepoint are included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
2645335|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to PT at Month 6|Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.|6 months post vaccination|All participants providing a breast milk sample at the timepoint are included in the analysis population.|||EU/mL||Full Range|Geometric Mean
2645336|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to PT at Week 6|Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.|6 weeks post vaccination|All participants providing a breast milk sample at the timepoint are included in the analysis population.|||EU/mL||Full Range|Geometric Mean
2645337|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to PT at Week 2|Breast milk was collected from participants at 2 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.|2 weeks post vaccination|All participants providing a breast milk sample at the timepoint are included in the analysis population.|||EU/mL||Full Range|Geometric Mean
2645338|NCT01711645|Secondary|ELISA GMC of Breast Milk IgA to Pertussis Toxin (PT) at Baseline.|Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the PT antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. The lower limit of quantitation (LLOQ) of the assay was 10. Results of <10 were reported as half the LLOQ (5).|Baseline (prior to vaccination)|All participants providing a breast milk (colostrum) sample at the timepoint are included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
2645339|NCT01711645|Primary|Kinetics of the ELISA IgG Antibody Rise in Serum|The assessment of the kinetics of the ELISA IgG antibody rise in serum was defined by the protocol as the geometric mean fold rise at each timepoint (reported separately above). No additional analysis was pre-defined or performed for this outcome measure.|Prior to and following Tdap, through 24 months post-vaccination|No analysis was conducted for this outcome measure. See previous outcome measures for geometric mean fold rises at each timepoint.||||||
2645340|NCT01711645|Primary|Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 24|Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 24 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.|Prior to and 24 months after vaccination|All participants with blood collected and results reported at both timepoints are included in the analysis population.|||Participants|||Count of Participants
2645341|NCT01711645|Primary|Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 18|Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 18 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.|Prior to and 18 months after vaccination|All participants with blood collected and results reported at both timepoints are included in the analysis population.|||Participants|||Count of Participants
2645342|NCT01711645|Primary|Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 12|Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 12 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.|Prior to and 12 months after vaccination|All participants with blood collected and results reported at both timepoints are included in the analysis population.|||Participants|||Count of Participants
2645343|NCT01711645|Primary|Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 6|Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.|Prior to and 6 months after vaccination|All participants with blood collected and results reported at both timepoints are included in the analysis population.|||Participants|||Count of Participants
2645344|NCT01711645|Primary|Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 6|Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.|Prior to and 6 weeks after vaccination|All participants with blood collected and results reported at both timepoints are included in the analysis population.|||Participants|||Count of Participants
2645345|NCT01711645|Primary|Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 2|Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 2 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.|Prior to and 2 weeks after vaccination|All participants with blood collected and results reported at both timepoints are included in the analysis population.|||Participants|||Count of Participants
2645346|NCT01711645|Primary|ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 24|Blood was collected from participants at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.|24 months post vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
2645347|NCT01711645|Primary|ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 18|Blood was collected from participants at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.|18 months post vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
2645348|NCT01711645|Primary|ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 12|Blood was collected from participants at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.|12 months post vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
2645372|NCT01711424|Secondary|Tear Break Up Time (TBUT)|TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The longer it takes, the more stable the tear film.|Baseline, Week 4|All participants with complete data available for this outcome measure at Baseline and Week 4.|||Seconds||Full Range|Median
2645349|NCT01711645|Primary|ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 6|Blood was collected from participants at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.|6 months post vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
2645350|NCT01711645|Primary|ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 6|Blood was collected from participants at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.|6 weeks post vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
2645351|NCT01711645|Primary|ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 2|Blood was collected from participants at 2 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.|2 weeks post vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
2645352|NCT01711645|Primary|ELISA Geometric Mean Concentrations (GMC) of Serum IgG to PT, FHA, PRN and FIM at Baseline|Blood was collected from participants at baseline prior to vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). A value of 5 EU/mL was imputed for results reported as below the lower limit of quantitation (LLOQ) (<10 EU/mL). The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.|Baseline (prior to vaccination)|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||EU/mL||95% Confidence Interval|Geometric Mean
2645353|NCT01711645|Primary|Geometric Mean Fold Rise in Serum IgG by ELISA at Month 24|Blood was collected from participants at baseline prior to vaccination and at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.|Prior to and 24 months following vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||Fold Rise||95% Confidence Interval|Geometric Mean
2645354|NCT01711645|Primary|Geometric Mean Fold Rise in Serum IgG by ELISA at Month 18|Blood was collected from participants at baseline prior to vaccination and at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.|Prior to and 18 months following vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||Fold Rise||95% Confidence Interval|Geometric Mean
2645355|NCT01711645|Primary|Geometric Mean Fold Rise in Serum IgG by ELISA at Month 12|Blood was collected from participants at baseline prior to vaccination and at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.|Prior to and 12 months following vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||Fold Rise||95% Confidence Interval|Geometric Mean
2645356|NCT01711645|Primary|Geometric Mean Fold Rise in Serum IgG by ELISA at Month 6|Blood was collected from participants at baseline prior to vaccination and at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.|Prior to and 6 months following vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||Fold Rise||95% Confidence Interval|Geometric Mean
2645357|NCT01711645|Primary|Geometric Mean Fold Rise in Serum IgG by ELISA at Week 6|Blood was collected from participants at baseline prior to vaccination and at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.|Prior to and 6 weeks following vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||Fold Rise||95% Confidence Interval|Geometric Mean
2645358|NCT01711645|Primary|Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2|Blood was collected from participants at baseline prior to vaccination and at 2 weeks after vaccination for assessment of IgG by ELISA against the pertussis toxin (PT), filamentous hemaggluttinin (FHA), pertactin (PRN) and fimbrae (FIM) antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% confidence interval (CI).|Prior to and 2 weeks following vaccination|All participants with specimens collected and data reported for baseline and the post-vaccination timepoint were included in the analysis population.|||Fold Rise||95% Confidence Interval|Geometric Mean
2645359|NCT01711619|Secondary|Back Pain Responder Rate (≥30%) at 9 Months|Percentage of participants who responded to the treatment, where response was defined as ≥ 30% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 9-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable.|9 months|"The Intent-to-Treat patient set (ITT) consists of all subjects as they were randomized into the study.~The As Treated consists of all patients of the ITT patient set, but excludes those with major protocol deviations; they are analysed according to last treatment received before the actual assessment, without replacement of missing data"|||Percentage of responders||95% Confidence Interval|Number
2645360|NCT01711619|Secondary|Back Pain Responder Rate (≥50%) at 6 Months|Percentage of participants who responded to the treatment, where response was defined as ≥ 50% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 6-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable.|6 months|"The Intent-to-Treat patient set (ITT) consists of all subjects as they were randomized into the study.~The As Treated consists of all patients of the ITT patient set, but excludes those with major protocol deviations; they are analysed according to last treatment received before the actual assessment, without replacement of missing data."|||Percentage of responders||95% Confidence Interval|Number
2645361|NCT01711619|Secondary|Average Change in Back Pain Intensity|Average change in back pain intensity from baseline to the 6 and 9-month follow-up visits. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable. A reduction in average pain score is indicated by a negative number.|6 and 9 months|"The Intent-to-Treat patient set (ITT) consists of all subjects as they were randomized into the study.~The As Treated consists of all patients of the ITT patient set, but excludes those with major protocol deviations; they are analysed according to last treatment received before the actual assessment, without replacement of missing data."|||units on a scale||Standard Deviation|Mean
2645362|NCT01711619|Primary|Effectiveness of Treatment on Reduction of Back Pain Intensity|Percentage of participants who responded to the treatment, where response was defined as ≥ 50% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 9-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable.|9 months|"The Intent-to-Treat patient set (ITT) consists of all subjects as they were randomized into the study.~The As Treated consists of all patients of the ITT patient set, but excludes those with major protocol deviations; they are analysed according to last treatment received before the actual assessment, without replacement of missing data."|||Percentage of responders||95% Confidence Interval|Number
2645363|NCT01711541|Secondary|OS (Phase II)|Summarized using the method of Kaplan-Meier, and compared between groups using the log-rank test. Multivariate Cox proportional hazards regression models will be used to further explore group differences adjusting for other prognostic factors, as well as to estimate hazard ratios.|Up to 5 years|No patients were eligible for this Phase II endpoint. The Phase II portion of this study never opened.||||||
2645364|NCT01711541|Secondary|DSS (Phase II)|Summarized using cumulative incidence, and will be compared between groups using Gray's test. Multivariate Cox proportional hazards regression models will be used to further explore group differences adjusting for other prognostic factors, as well as to estimate hazard ratios.|Up to 5 years|No patients were eligible for this Phase II endpoint. The Phase II portion of this study never opened.||||||
2645365|NCT01711541|Secondary|Time to Local or Distant Progression (Phase II)|Summarized using the method of Kaplan-Meier, and compared between groups using the log-rank test. Multivariate Cox proportional hazards regression models will be used to further explore group differences adjusting for other prognostic factors, as well as to estimate hazard ratios.|Up to 5 years|No patients were eligible for this Phase II endpoint. The Phase II portion of this study never opened.||||||
2645366|NCT01711541|Secondary|Disease-free Survival (Phase II)|Summarized using the method of Kaplan-Meier, and compared between groups using the log-rank test. Multivariate Cox proportional hazards regression models will be used to further explore group differences adjusting for other prognostic factors, as well as to estimate hazard ratios.|Up to 5 years|No patients were eligible for this Phase II endpoint. The Phase II portion of this study never opened.||||||
2645367|NCT01711541|Secondary|PFS (Phase II)|Summarized using the method of Kaplan-Meier, and compared between groups using the log-rank test. Multivariate Cox proportional hazards regression models will be used to further explore group differences adjusting for other prognostic factors, as well as to estimate hazard ratios.|Up to 5 years|No patients were eligible for this Phase II endpoint. The Phase II portion of this study never opened.||||||
2645368|NCT01711541|Secondary|Toxicity (Phase I and Phase II)|Adverse Events were collected each cycle during treatment and follow-up according to the CTCAE v4.0 guidelines. The worst graded adverse event was determined for each patient. Below is a table of the number of patients that reported a Grade 3 or Grade 4 or Grade 5 as their worst reported event.|upt to 5 years|All patients that started protocol treatment and were evaluated for adverse events are included in this analysis. The Phase II portion of the study never opened, and therefore no data was collected.|||Participants|||Count of Participants
2645369|NCT01711541|Primary|Relative Change in Tumor Size as Measured by RECIST (Phase II)|Treatment arms will be compared using the nonparametric Wilcoxon rank-sum test.|From baseline to 6 weeks|The Phase II portion of this study never opened and no analysis was planned.||||||
2645370|NCT01711541|Primary|Dose Limiting Toxicity (Phase I)|"Dose Limiting Toxicity (DLTs) will be assessed during the first cycle of induction chemotherapy.~The following events are considered DLTs: Grade 4 neutropenia (ANC < 500) lasting more than 14 days, Febrile neutropenia, Grade 4 thrombocytopenia, dose delay of greater than 3 weeks due to failure to recover counts, treatment-related grade 3 or grade 4 non-hematological toxicity (excluding alopecia, fatigue, hypersensitivity reaction, nausea, vomiting, constipation, diarrhea, hypokalemia, hypomagnesemia, hypocalcemia, hypophosphatemia, and grade 3 hypertension), a dose delay of greater than 3 weeks for non-hematological toxicity despite replacement of electrolytes, maximum treatment for diarrhea, nausea, vomiting, and hypertension, any drug-related death.~The number of patients reporting a DLT are reported below. The maximum tolerated dose (MTD) will be determined as the highest dose where 1 or fewer out of 6 patients reports a DLT."|Up to 3 weeks|Dose Level 0 was not included in this outcome due to a change in treatment regimen. On Dose Level 0B, 1 patient was ineligible based on protocol criteria. On dose level 2, 1 patient cancelled prior to treatment, 1 had a dosing error and 1 pt did not complete cycle 1. On Dose Level 3, 1 patient cancelled prior to treatment.|||Participants|||Count of Participants
2645371|NCT01711424|Secondary|Schirmer Score|The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye.|Baseline, Week 4|All participants with complete data available for this outcome measure at Baseline and Week 4.|||mm/5 min||Full Range|Median
2645373|NCT01711424|Secondary|Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS®|The physician rated their satisfaction with OPTIVE PLUS® for the treatment of their patient's dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).|Week 4|All participants with data available for this outcome measure.|||Participants|||Number
2645374|NCT01711424|Primary|Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS®|Patients rated their satisfaction with OPTIVE PLUS® as treatment for dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).|Week 4|All participants with data available for this outcome measure.|||Participants|||Number
2645375|NCT01711372|Secondary|Area Under the Receiver Operating Characteristic (ROC) Curve- Continuous Performance Task (CPT)|"CPT measures sustained attention. Participants were asked to press the space bar whenever any letter except the letter X: appeared on the computer screen. Used the percent certainty that the CPT II results were in the clinical range in this analysis. ROC charts the false-positive rate (horizontal axis) and the sensitivity or true-positive rate (vertical axis) of discriminating child psychiatric patients with and without ADHD. Determines diagnostic accuracy of Conners scales for ADHD. ROC analysis summarizes diagnostic efficiency with the Area Under the Curve (AUC) statistic. The AUC ranges from 0.5 (for a diagnostically useless test) to 1.0 (for a diagnostic test that is a perfect predictor)."|30 minutes|Data from both participants with and without ADHD used in calculation of AUC of ROC. Diagnostic accuracy applies to both arm/groups of participants. Company no longer exists. Only information in published study results available.|||Proportion of accurate ADHD Diagnoses|||Number
2645376|NCT01711372|Secondary|Area Under the Receiver Operating Characteristic (ROC) Curve- Conners Brief Rating Scale Parent Version (Inattention Subscale)|Parent completed the Connors Brief rating Scale Parent Version, with the Inattention subscale extracted for analysis. Scores for this assessment are converted to percentile scores for each age group with higher scores indicating more likelihood of ADHD. ROC charts the false-positive rate (horizontal axis) and the sensitivity or true-positive rate (vertical axis) of discriminating child psychiatric patients with and without ADHD. Determines diagnostic accuracy of Conners Scale for ADHD. ROC analysis summarizes diagnostic efficiency with the area under the curve (AUC) statistic. The AUC ranges from 0.5 (for a diagnostically useless test) to 1.0 (for a diagnostic test that is a perfect predictor).|30 minutes|Data from both participants with and without ADHD used in calculation of AUC of ROC. Diagnostic accuracy applies to both arm/groups of participants. Company no longer exists. Only information in published study results available.|||Proportion of accurate ADHD Diagnoses|||Number
2645377|NCT01711372|Primary|Area Under the Receiver Operating Characteristic (ROC) Curve- Groundskeeper Game|ROC charts the false-positive (horizontal axis) and the sensitivity or true-positive rate (vertical axis) of the Groundskeeper game at discriminating child psychiatric patients with and without ADHD. Determines diagnostic accuracy of Groundskeeper game for ADHD. For each participant, predicted values were computed from the logistic regression models (correcting for age, sex and medication status). For each successive point on the logit scale sensitivity and specificity of the logit was computed as a predictor of ADHD diagnosis, by predicting those higher than the cut-point to have ADHD and the others not to have ADHD. These data were used to draw the ROC curve. ROC analysis summarized diagnostic efficiency with the area under the curve (AUC) statistic. The AUC ranges from 0.5 (for a diagnostically useless test) to 1.0 (for a diagnostic test that is a perfect predictor).|30 minutes|Data from both participants with and without ADHD used in calculation of AUC of ROC. Diagnostic accuracy applies to both arm/groups of participants. Company no longer exists. Only information in published study results available.|||Proportion of accurate ADHD Diagnoses|||Number
2645378|NCT01711359|Secondary|Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib||Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 24; Week 32; Pre-dose|All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.|||nanomole/Liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2645379|NCT01711359|Secondary|Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib||Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 24; Week 32; Pre-dose|All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.|||nanomole/Liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2645380|NCT01711359|Secondary|Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores|The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and an observed value at the time point being summarized.|||Percentage of Impairment||Standard Deviation|Mean
2645381|NCT01711359|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores|"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue."|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
2645429|NCT01710839|Secondary|Adverse Events|Incidence and severity of adverse events (ocular and non-ocular).|12 months||||Participants|||Count of Participants
2646245|NCT01705080|Secondary|Renal Function Change Based on eGFR (Estimated Glomerular Filtration Rate) at 6 Months||Baseline and 6 months||||mL/min per 1.73m^2||Standard Deviation|Mean
2645382|NCT01711359|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)|A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||millimeter||Standard Deviation|Mean
2645383|NCT01711359|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores|European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
2645384|NCT01711359|Secondary|Change From Baseline in Mental Component Score (MCS) and Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
2645385|NCT01711359|Secondary|Change From Baseline in Worst Joint Pain Numeric Rating Scale (NRS)|"Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents no pain and 10 represents pain as bad as you can imagine."|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
2645386|NCT01711359|Secondary|Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)|"Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents no tiredness and 10 represents as bad as you can imagine."|Baseline, Week 24; Baseline Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
2645387|NCT01711359|Secondary|Change From Baseline in Duration of Morning Joint Stiffness|Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on the day of the study visit. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.|Baseline, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||Minutes||95% Confidence Interval|Median
2645388|NCT01711359|Secondary|Change From Baseline in Joint Space Narrowing and Bone Erosion Scores|X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing. The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints, with 0 indicating no erosion and the highest score (5 for the hand and 10 for the foot) indicating extensive loss of bone from more than one half of the articulating bone. Erosion scores ranged from 0 (no erosion) to 280 (high erosion).|Baseline, Week 24; Baseline, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment. Missing values due to discontinuation of study, rescue, or missing data were imputed using LE.|||units on a scale||Standard Deviation|Mean
2645389|NCT01711359|Secondary|Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission|"The ACR/EULAR definitions of RA remission include a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1."|Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||percentage of participants|||Number
2646246|NCT01705080|Secondary|Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation||6 months, 2 years and 5 years post procedure||||Participants|||Count of Participants
2645390|NCT01711359|Secondary|Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)|DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 24; Baseline, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
2645391|NCT01711359|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score|The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.|Baseline, Week 24; Baseline, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified last observation carried forward (mLOCF).|||units on a scale||Standard Deviation|Mean
2645392|NCT01711359|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|"ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. ACR70 Responder is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinued study or drug or were rescued before analysis timepoint were deemed non-responders."|Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Percent of participants|||Number
2645393|NCT01711359|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|"ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders."|Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||Percent of participants|||Number
2645394|NCT01711359|Secondary|Percentage of Participants Who Achieved a Simplified Disease Activity Index (SDAI) Score ≤3.3|SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.|Week 24|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||percentage of participants|||Number
2645395|NCT01711359|Secondary|Change From Baseline in the Modified Total Sharp Score (mTSS)|"X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS (van der Heijde 2000). This methodology quantified the extent of bone erosions and joint space narrowing for 44 and 42 joints, with higher scores representing greater damage.~The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448."|Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessments. Missing values due to discontinuation of study, rescue, or missing data were imputed using linear extrapolation (LE).|||units on a scale||Standard Deviation|Mean
2645396|NCT01711359|Secondary|Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.|||units on a scale||Standard Deviation|Mean
2645397|NCT01711359|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area are averaged to calculate the HAQ-DI score, which ranges from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicates an improvement in the participant's condition.|Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified baseline observation carried forward (mBOCF).|||units on a scale||Standard Deviation|Mean
2645398|NCT01711359|Secondary|Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)|"ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders."|Week 52|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using nonresponder imputation (NRI).|||Percent of participants|||Number
2645399|NCT01711359|Primary|Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)|"ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders."|Week 24|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using nonresponder imputation (NRI).|||Percent of participants|||Number
2645400|NCT01711216|Secondary|Time to Relapse|The intention was to measure time to relapse, but since a regular cycle was maintained longer than the period of follow up observation, no resulting variable counted in time was received. Instead, what was measured was the percentage of participants who maintained a regular cycle. Measured only for patients who had achieved cycle regularization at the end of treatment period.|Up to 6 months or longer after ended treatment|"Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.~Among the patients who achieved cycle regularization (Follow-up Analysis Set), a majority (>85%) maintained regular cycles for the whole follow-up period"|||percentage of subjects|||Number
2645401|NCT01711216|Primary|Number of Patients With Regular Menstrual Cycles During Follow-up (by Number of Cycles)||up to 6 months|Follow-up analysis set 915 patients. Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. Therefore, 860 patients were analyzed.|||participants|||Number
2645402|NCT01711216|Primary|Number of Patients Received Dydrogesterone Therapy Cycles (by Cycle Number)||up to 6 months|Follow-up analysis set 915 patients. Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing. Therefore, 860 patients were analyzed.|||participants|||Number
2645403|NCT01711216|Secondary|Change of Intensity of Anxiety|Will be measured only for patients who had achieved cycle regularization at the end of treatment period. Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety|From 1 month to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.|||units on a scale||Standard Deviation|Mean
2645404|NCT01711216|Secondary|Change of Pain Intensity During Menstruation|Measured only for patients who had achieved cycle regularization at the end of treatment period. Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain|From 1 month to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.|||units on a scale||Standard Deviation|Mean
2645405|NCT01711216|Secondary|Change of Duration of Menstrual Bleeding in Days in Group of Patients With Oligomenorrhea|Measured only for patients who had achieved cycle regularization at the end of treatment period. Oligomenorrhea is defined as cycle duration > 35 days|From 1 month to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Patients with oligomenorrhea in subset of FAS.|||days||Standard Deviation|Mean
2645406|NCT01711216|Secondary|Change of Duration of Menstrual Bleeding in Days in Group of Patients With Polymenorrhea|Measured only for patients who had achieved cycle regularization at the end of treatment period. Polymenorrhea is defined as cycle duration < 21 days|From 1 month to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Patients with polymenorrhea in subset of FAS.|||days||Standard Deviation|Mean
2645407|NCT01711216|Secondary|Proportion of Patients With 6 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period|Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive|Up to 12 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.|||percentage of subjects|||Number
2645408|NCT01711216|Secondary|Proportion of Patients With 3 Consecutive Regular Cycles Out of Total Number of Patients Who Had Achieved Cycle Regularization at the End of Treatment Period|Measured only for patients who had achieved cycle regularization at the end of treatment period. Regular cycle is defined as cycle duration 21-35 days, inclusive|Up to 9 months|Follow-up Analysis Set (subset of FAS): Patients in the FAS for whom the last reported menstrual cycle during the treatment period was regular. Data for 55 patients was missing.|||percentage of subjects|||Number
2645409|NCT01711216|Secondary|Overall Clinical Response on Treatment Assessed by Physician|Overall clinical response assessed by physician will be determined based on a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor response.|Up to 6 months|Full Analysis Set (FAS): 955 patients. All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 36 patients were missing. Therefore, 919 patients were analyzed.|||participants|||Number
2645410|NCT01711216|Secondary|Patient Satisfaction With the Treatment|Patient satisfaction will be determined based on a 5-point Clinical Global Impression of Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, 5 = very satisfied.|Up to 6 months|Full Analysis Set (FAS): 955 patients. All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 36 patients were missing. Therefore, 919 patients were analyzed.|||participants|||Number
2645411|NCT01711216|Secondary|Change of Intensity of Anxiety From Baseline to the End of Treatment|Intensity of anxiety will be measured using 11-point scale where 0 means no anxiety and 10 means maximum anxiety|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data for 51 patients missing.|||units on a scale||Standard Deviation|Mean
2645412|NCT01711216|Secondary|Change of Pain Intensity During Menstruation From Baseline to End of Treatment|Pain intensity will be measured using 11-point Likert scale where 0 means no pain and 10 means worst pain|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Data from 39 patients missing|||units on a scale||Standard Deviation|Mean
2645413|NCT01711216|Secondary|Change of Duration of Menstrual Bleeding in Group of Patients With Oligomenorrhea|Oligomenorrhea is defined as cycle duration > 35 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with oligomenorrhoea in FAS|||days||Standard Deviation|Mean
2645414|NCT01711216|Secondary|Change of Duration of Menstrual Bleeding in Group of Patients With Polymenorrhea|Polymenorrhea is defined as cycle duration < 21 days and the duration of menstrual bleeding was evaluated from baseline to end of treatment in days|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with polymenorrhoea in FAS|||days||Standard Deviation|Mean
2645415|NCT01711216|Secondary|Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Oligomenorrhea|Oligomenorrhea is defined as cycle duration > 35 days and the change in duration of the menstrual cycle during treatment was evaluated|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with oligomenorrhoea in FAS|||days||Standard Deviation|Mean
2645416|NCT01711216|Secondary|Change of Cycle Duration From Baseline to End of Treatment in Days in Group of Patients With Polymenorrhea|Polymenorrhea was defined as cycle duration < 21 days and the change in duration of the menstrual cycle during treatment was evaluated|From 1 month to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles. Patients with polymenorrhoea in FAS|||days||Standard Deviation|Mean
2645417|NCT01711216|Secondary|Proportion of Patients Reporting at Least One Regular Cycle Over the Treatment Period|Regular cycle is defined as cycle duration between 21 to 35 days, inclusive. Treatment period in this observational program can be from 1 cycle to 6 consecutive cycles. This program does not include patients who required dydrogesterone therapy, according to physician's decision, more than 6 consecutive cycles|Up to 6 months|Full Analysis Set (FAS): All eligible patients who received at least 1 dose of program drug and at most 6 treatment cycles|||percentage of subjects|||Number
2645418|NCT01711177|Primary|Blood Oxygenation|For each subject, all the measurements will be done during an 1 hour appointment.|1 hour||||percentage of oxygenation||95% Confidence Interval|Mean
2645419|NCT01710891|Secondary|Failed Intubation|Defined as the operator switching to an alternate device or intubation technique after at least one unsuccessful intubation attempt.|from the start of the procedure until successful intubation up to one hour||||percentage of participants|||Number
2645420|NCT01710891|Secondary|Incidence of Hypoxia|Oxygen saturations will be recorded during the procedure, oxygen saturation less than 93% will be considered an occurrence of hypoxia|From the start of the procedure until successful intubation up to 1 hour||||Percentage of Hypoxemia||95% Confidence Interval|Number
2645421|NCT01710891|Secondary|Aspiration Pneumonia|The occurrence of aspiration pneumonia as defined by the clinical diagnosis in the patients chart and or radiographic determination of aspiration during the 28 days after the intubation procedure|from the time of hospital admission up to 28 days||||Percentage of Aspiration Pneumonia||95% Confidence Interval|Number
2645422|NCT01710891|Secondary|Length of Stay|The time in days from hospital admission until discharge.|From the time of hospital admission until discharge up to 28 days||||Days||95% Confidence Interval|Median
2645423|NCT01710891|Primary|Time to Intubation|The time in seconds from the time at which the intubating device is first placed in the patient's mouth until the time of successful intubation|From the time the first device entered the patients mouth until successful intubation up to 1 hour||||Seconds||95% Confidence Interval|Mean
2645424|NCT01710891|Primary|First Pass Success in Patients Undergoing Emergency Intubation, Intubated With Either Direct Larynogoscopy or Video Laryngoscopy Using a C-MAC Device.|An attempt is counted as the intubating device entering the patients mouth until it is removed. Intubation success is defined as the endotracheal tube being placed in the patients lungs as confirmed by auscultation and end tidal carbon dioxide|During intubation procedure up to 1 hour||||percentage of participants||95% Confidence Interval|Number
2645425|NCT01710839|Secondary|Visual Field|Goldman Visual Field changes at 6 and 12 months from baseline. Goldmann perimetry is a method used to map a patient's field of vision (central and peripheral). Changes will be assessed by manual digital quantification of GVF plots.|6 and 12 Months|Patients who completed GVF testing at baseline, M6, and M12 with adequate fixation and cooperation during testing were included in GVF analyses (n=14)|||square degrees||Standard Error|Mean
2645426|NCT01710839|Secondary|Aqueous VEGF Levels|VEGF, other cytokines and ranibizumab levels in aqueous and serum samples at randomization and at the exit or early termination visit.|12 Months|Analysis of this outcome measure is still in progress. Data will be reported when the analysis is completed.||||||
2645427|NCT01710839|Secondary|Central Foveal Outcome|Mean change in Central Foveal Volume on High Resolution OCT.|12 months|1 patient withdrew from the study before month 12|||cubic millimeters||Standard Deviation|Mean
2645428|NCT01710839|Secondary|Neovascularization of the Iris, Optic Nerve and Elsewhere|Percent of patients that develop neovascularization of the iris, optic nerve and/or elsewhere.|12 months||||percentage of patients|||Number
2645432|NCT01710839|Primary|Visual Acuity|Evaluate the mean change from baseline in ETDRS best-corrected visual acuity at 12 months. The ETDRS protocol is a widely accepted international standard for macular laser photocoagulation treatment. A higher score represents better functioning.|12 month period|1 patient withdrew from the study before month 12|||ETDRS BCVA Letters||Standard Error|Mean
2645433|NCT01710839|Primary|Total Number of Intravitreal Injections Over a 12 Month Period|Assess the number of intravitreal injections over 12 months.|12 months||||injections||Full Range|Mean
2645434|NCT01710800|Primary|Number of Impedance Episodes Following PPI and Placebo|Impedance is defined as a 50% decrease from baseline in retrograde movement of liquid from the stomach to the esophagus. In other words, it measures the number of retrograde reflux episodes.|1 week|We analyzed as per protocol. Only patients who completed both 24 hour pH studies with impedance were analyzed.|||number of episodes||Standard Deviation|Mean
2645435|NCT01710787|Secondary|Intraoral Soft-tissue Anesthesia (Onset and Duration)|Mean onset and duration of incisive papilla anesthesia based on number of patients who reported no pain when soft-tissue was tested with a probe at designated timepoints|up to 120 mins post-dose|The analysis population includes patients who received a rescue injection of local anesthetic. Local anesthetic may cause soft-tissue anesthesia, impacting this endpoint. In addition, only patients from one site (out of the two sites for the study) are used for this analysis. The other site administered this assessment incorrectly.|||minutes||Standard Deviation|Mean
2645436|NCT01710787|Secondary|Alcohol Sniff Test|The distance from the nose (in centimeters) that a patient is able to detect the smell of alcohol on an alcohol swab.|administered at baseline, 120 minutes and approximately 24 hours after drug administration||||cm||Standard Deviation|Mean
2645437|NCT01710787|Secondary|The Profile Over Time of Diastolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
2645438|NCT01710787|Secondary|The Profile Over Time of Systolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
2645439|NCT01710787|Secondary|The Profile Over Time of Heart Rate||from baseline to 120 minutes following drug administration||||beats per minute||Standard Deviation|Mean
2645440|NCT01710787|Secondary|Absolute Maximum Change From Baseline in Diastolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
2645441|NCT01710787|Secondary|Absolute Maximum Change From Baseline in Systolic Blood Pressure||from baseline to 120 minutes following drug administration||||mm Hg||Standard Deviation|Mean
2645442|NCT01710787|Secondary|Absolute Maximum Change From Baseline in Heart Rate||from baseline to 120 minutes following drug administration||||bpm||Standard Deviation|Mean
2645443|NCT01710787|Secondary|Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and to a Value Lower Than 50 mm Hg||at any time within 120 minutes following drug administration||||participants|||Number
2645444|NCT01710787|Secondary|Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 105 mm Hg||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
2645445|NCT01710787|Secondary|Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
2645446|NCT01710787|Secondary|Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
2645447|NCT01710787|Secondary|Number of Participants With a Heart Rate Lower Than 50 Bpm||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
2645448|NCT01710787|Secondary|Number of Participants With a Heart Rate Higher Than 125 Bpm||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
2645449|NCT01710787|Secondary|Intraoral Soft-tissue Anesthesia (Yes/no)|Number of patients who reported no pain when incisive papilla soft-tissue was tested with a probe at designated timepoints|at Baseline, 15, 30, 45, 60, 90, and 120 minutes with a 3 minute window|Only patients from one site (out of the two sites for the study) are used for this analysis. The other site administered this assessment incorrectly.|||Participants|||Count of Participants
2645450|NCT01710787|Primary|Number of Participants Who Completed the Study Dental Procedure After Without Need for Rescue by Injection of Local Anesthetic.|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.|at 15 minutes with a 3 minute window||||percentage of patients||95% Confidence Interval|Number
2645451|NCT01710709|Secondary|Percentage of Participants Who Remained Stable at End of Treatment in Phase C|The secondary objective was to evaluate the efficacy, as measured by the percentage of stable participants at baseline who remained stable at the end of treatment in the IM depot maintenance phase, of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to subjects with bipolar I disorder.|Up to Week 52|IM Depot Maintenance Phase Efficacy Sample: All participants who entered the IM Depot Maintenance Phase, received at least 1 dose of aripiprazole IM depot, and had at least 1 post-baseline efficacy evaluation in the IM Depot Maintenance Phase. Number analyzed is the number of participants evaluated at the specified trial week.|||Percentage of participants|||Number
2645460|NCT01710657|Secondary|Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Treatment Period (i.e., Titration + Maintenance Period)|"Partial-onset seizure (POS) frequency per 28 days was calculated as:~POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.~A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Treatment Period."|8-week Baseline Period (Visit 1 to 3) to the 16-week Treatment Period (Visit 3 to 8)|The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.|||Seizures per 28 days||Full Range|Median
2646247|NCT01705080|Secondary|Percentage of Participants With Peri-procedural Events 30 Days Post-procedure||30 days post procedure||||Participants|||Count of Participants
2645452|NCT01710709|Primary|Number of Participants With Injection Site Evaluations (Pain, Redness, Swelling, Induration) Measured by Investigator Rating|Injection-site reactions were assessed by the investigator (or qualified designee) and the participant. Investigators rated localized pain, redness, swelling, and induration at the most recent injection site using a 4-point categorical scale (absent, mild, moderate, severe) . The participant indicated the degree of pain at the most recent injection site using a VAS. Ratings ranged from 0 (no pain) to 100 (unbearably painful). Ratings included were: 0 = absent, 1 = mild, 2 = moderate, 3 = severe. These assessments occurred at trial visits where injections occurred (scheduled and unscheduled), beginning with the first dose of open-label aripiprazole IM depot administered at the final visit of the Oral Stabilization Phase and continued through the last injection prior to the end of the IM Depot Maintenance Phase/Early termination (ET) visit (ie, evaluations were not done at end of the IM Depot Maintenance Phase/ET visit).|Up to Week 52|IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase.|||Participants|||Count of Participants
2645453|NCT01710709|Primary|Number of Participants Experiencing Suicidal Events and Their Classification According to the Completion of Columbia Suicide Severity Rating Scale (C-SSRS)|"Suicidality was monitored throughout the trial using the C-SSRS at every visit. The C-SSRS scale consisted of a screening/baseline evaluation that assessed the participant's lifetime experience and experience over the last 90 days with suicide events and suicidal ideation and a post-baseline/ Since Last Visit evaluation that focused on suicidality since the last trial visit."|Up to Week 52|IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase.|||Participants|||Count of Participants
2645454|NCT01710709|Primary|Extrapyramidal Symptoms Will be Assessed by Mean Change From Baseline on Abnormal Involuntary Movement Scale(AIMS), Simpson-Angus Scale (SAS), Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS Only Used in Japan) and Barnes Akathisia Rating Scale (BARS)|AIMS: 10 items described dyskinesia signs; 0-absence/no awareness; 4-severe condition/severe distress. Total score for Items 1-10 ranges from 0 to 40; a higher score reflects severe condition. SAS:Consisted of 10 parkinsonism signs;1-no symptoms;5-severe.Total score for Items 1-10 ranges from 1 to 50;a higher score reflects severe condition.DIEPSS:A 9-item rating scale (8 assessed individual symptoms [4 categories of parkinsonism, akathisia, dystonia & dyskinesia]+1 assessed general severity) was used;0-no symptoms/normal, 4-severe.Total score (8 individual symptom items) was in range of 0 to 32 (a higher score reflects severe condition).BARS:Consisted of 4 items related to akathisia:objective observation, subjective feelings of restlessness, distress, global clinical evaluation.Only BARS global clinical assessment score has been presented and rated using scale:0-absence of symptoms;5-severe akathisia.Total BARS global score ranges from 0 to 5,a higher score reflects severe condition.|Baseline, Week 28, and Week 52|IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase.|||Units on a scale||Standard Deviation|Mean
2645455|NCT01710709|Primary|Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECGs)|Twelve-lead ECGs were recorded at specified visits. For each time point, three 12-lead ECG recordings were obtained approximately 5 minutes apart. Additional 12-lead ECGs were permitted to be obtained at the investigator's discretion and were to always be obtained in the event of an early termination. The ECGs were evaluated at the investigational site to determine the participant's eligibility and to monitor safety during the trial.|Up to Week 52|IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase.|||Participants|||Count of Participants
2645456|NCT01710709|Primary|Number of Participants With Clinically Significant Abnormal Vital Signs|TEAEs of potential clinical relevance included abnormal values in body weight, systolic and diastolic blood pressure, heart rate, and body temperature that were identified based on pre-defined criteria. Abnormal laboratory values in participants were reported as SAE/AEs and are reported in the SAE/other AE section of this report.|Up to Week 52|IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase.|||Participants|||Count of Participants
2645457|NCT01710709|Primary|Number of Participants With Clinically Significant Abnormal Laboratory Test Results|Standard safety variables to be analyzed included clinical laboratory tests. Incidence of treatment emergent adverse events (TEAEs) of potential clinical relevance included abnormal values in serum chemistry, hematology, urinalysis, and other laboratory test that were identified based on pre-defined criteria. Abnormal laboratory values in participants were reported as serious adverse event/adverse events (SAE/AEs) and are reported in the SAE/other AE section of this report.|Up to Week 52|IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase.|||Participants|||Count of Participants
2645458|NCT01710709|Primary|Injection Site Pain Measured by the Visual Analog Scale (VAS)|Injection-site pain was evaluated by mean visual analog scale (VAS) scores as reported by the participant after each injection at visits where an injection occurred. Ratings ranged from 0 (no pain) to 100 (unbearably painful).|Up to Week 52|"All participants who received at least one dose of aripiprazole IM depot in Phase C. It is equivalent to safety set (SAF) for Phase C.~Number analyzed = Total number of participants with at least one observation of the given parameter."|||Units on a scale||Standard Deviation|Mean
2645459|NCT01710709|Primary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or participant enrolled in the clinical trial and which does not necessarily have to have a causal relationship with the investigational medicinal product (IMP). AEs were assessed as a criteria for safety and tolerability.|Up to Week 52|IM Depot Maintenance Phase Safety Sample: All participants who received at least 1 dose of aripiprazole IM depot in the IM Depot Maintenance Phase. TEAEs = Treatment-emergent adverse events. discount. = discontinued (used in the table below)|||Participants|||Count of Participants
2645548|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 57|Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 57|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||mg/L||Standard Deviation|Mean
2646248|NCT01705080|Primary|Mean Change in Office Systolic Blood Pressure at 6 Months||Baseline and 6 months||||mmHg||Standard Deviation|Mean
2645461|NCT01710657|Secondary|Percent Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period|Calculates as 28-day seizure frequency during the Maintenance Period - 28-day seizure frequency during the Baseline Period, divided by the 28-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in Partial-Onset Seizure frequency from Baseline to the Maintenance Period.|8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)|The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.|||percentage change||Full Range|Median
2645462|NCT01710657|Secondary|The Proportion of Individual Patients Who Experience a 50 % or Greater Reduction in Seizure Frequency From Baseline to the Maintenance Period (50 % Responder Rate)||8-week Baseline Period (Visit 1 to 3) to the 12-week Maintenance Period (Visit 5 to 8)|The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.|||participants|||Number
2645463|NCT01710657|Primary|Change in Partial-Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period|"Partial-onset seizure (POS) frequency per 28 days was calculated as:~POS frequency = (Number of POS over the specified time interval) / (Number of days in the interval with available diary data) x 28.~A negative value in Change in Partial-onset seizure frequency indicates a reduction of Partial-onset seizure frequency from Baseline to the Maintenance Period."|8-week Baseline Period (Visit 1 to 3) and 12-week Maintenance Period (Visit 5 to 8)|The Full Analysis Set consists of all subjects who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline efficacy assessment.|||Seizures per 28 days||Full Range|Median
2645464|NCT01710527|Secondary|Assessment of Subject Well-being Questionnaire|Subject well-being questionnaire was planned to be conducted at 1.0 and 5.0 hour post-dose. During vital sign recording each participants was planned to be asked about his well-being recorded during post study safety assessments. The data for this outcome measure was not collected during the study. Thus the results summary for this outcome measure was not produced.|Up to 38 days|Safety population.||||||
2645465|NCT01710527|Secondary|Number of Participants With Abnormal Periodic Physical Examination Results|Brief physical examination was performed at each check-in, check-out and complete physical examination during screening and at the end of the clinical part of the study.|Up to 38 days|Safety population.|||Participants|||Number
2645466|NCT01710527|Secondary|Number of Participants With Abnormal Vital Sign Results|Vital signs measurements (blood pressure, respiratory rate, pulse rate and oral temperature) were conducted during screening and during post study safety assessments. Vital signs measurement were also performed at each check-in and at checkout and were also recorded before dosing of study drug, between 2-3, 9-10 and 36.0 hour post-dose. Measurements were recorded in sitting position after rest of at least 5 min.|Up to 38 days|Safety population.|||Participants|||Number
2645467|NCT01710527|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalized ratio >1.5.|Up to 38 days|Safety population was defined as participants who received at least one dose of the study drug.|||Participants|||Number
2645468|NCT01710527|Primary|Apparent First-order Elimination or Terminal Rate Constant|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The apparent first-order elimination or terminal rate constant was calculated from a semi logarithmic plot of the plasma concentration versus time. The parameter was calculated by linear least-square regression analysis using the last three (or more) non-zero plasma concentrations.|Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.|PK population. Data is presented for the participants available at the time of assessment.|||1/hour||Standard Deviation|Mean
2645469|NCT01710527|Primary|Percentage of Area Under Curve Extrapolated to Arrive at AUC0-infinity (AUC%_Extrapolated)|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. AUC%_Extrapolated was obtained by subtracting AUC0-t from AUC0-infinity divided by AUC0-infinity and multiplied by 100.|Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.|PK population. Data is presented for the participants available at the time of assessment.|||Percentage of area||Standard Deviation|Mean
2645470|NCT01710527|Primary|Terminal Half-life (T-half) Over Period|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. The elimination or terminal half-life was calculated by dividing 0.693 (natural logarithm of 2) with elimination rate constant obtained as semi logarithmic plot of the plasma concentration versus time.|Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.|PK population. Data is presented for the participants available at the time of assessment.|||hour||Standard Deviation|Mean
2645471|NCT01710527|Primary|Time of the Maximum Plasma Concentration (T-max) Over Period|Plasma samples for PK analysis were drawn at indicated time points of each treatment period. If the maximum value occurs at more than one point T-max was defined as the first time point with this value.|Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.|PK population. Data is presented for the participants available at the time of assessment.|||hour||Standard Deviation|Median
2645549|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 29|Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 29|Analysis population included all randomized participants who received at least 1 dose of study treatment.|||mg/L||Standard Deviation|Mean
2667331|NCT01516424|Secondary|Mean Change in PANSS Subscale Score at the End of Treatment|Mean Change in PANSS subscale score at the end of treatment at 8 weeks the frame of 8 weeks is from baseline|week 8|||||||
2645472|NCT01710527|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) and Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-infinity)|"Plasma samples for PK analysis were drawn at indicated time points of each treatment period.~AUC0-t was calculated by the linear trapezoidal rule from measured data points from time of administration until the time of last quantifiable concentration. AUC0- infinity was estimated by linear trapezoidal rule and was sum of the AUC0-t and extrapolated to infinity by dividing the estimated last measurable plasma concentration by elimination rate constant. The AUC0- infinity was the sum of the estimated and extrapolated parts."|Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.|PK population. Data is presented for the participants available at the time of assessment.|||ng*hour/mL||Standard Deviation|Mean
2645473|NCT01710527|Primary|Mean Maximal Measured Plasma Concentration (Cmax) After a Single Dose|Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified.|Pre- dose (0.0 hour), post-dose at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0 and 36.0 hour in each period.|PK population was defined as all participants who had a PK measurement available. Data is presented for the participants available at the time of assessment.|||Nanogram per milliltre (ng/mL)||Standard Deviation|Mean
2645474|NCT01710514|Secondary|Blood Progesterone Concentration||Weeks 2, 4, 5, 8, and end of study|FAS population|||ng/mL||Standard Deviation|Mean
2645475|NCT01710514|Secondary|Clinical Pregnancy Rate|Defined as presence of a gestational sac on transvaginal ultrasound|Week 4 of study|FAS with ET population|||percentage of participants||95% Confidence Interval|Number
2645476|NCT01710514|Secondary|Rate of Positive βeta Human Chorionic Gonadotrophin (βhCG)||Week 2 of study|FAS with ET population In the TID group 13 subjects had a positive beta-hCG assessment while 14 subjects had a positive clinical pregnancy at Week 4. This is because one subject had a negative beta-hCG at Week 2, but she had a positive local serum hCG on the same day and continued the trial. Then clinical and ongoing pregnancy were confirmed.|||percentage of participants||95% Confidence Interval|Number
2645477|NCT01710514|Primary|Ongoing Pregnancy Rate|Defined as identification of fetal survival and fetal heart movements on transvaginal ultrasound|Week 5 of study|FAS with ET population|||percentage of participants||95% Confidence Interval|Number
2645478|NCT01710514|Primary|The Proportion of Subjects With Blood Progesterone Concentration Not Less Than 10 ng/ml||Day 5 of treatment|FAS population|||percentage of subjects||95% Confidence Interval|Number
2645479|NCT01710501|Secondary|Number of Participants Developing Post-baseline Antiviral Resistance to Grazoprevir Among Participants Not Achieving SVR24 Response|Post-baseline resistance associated variants (RAV) analysis was conducted by comparing the amino acid sequences at virologic failure time points to those at baseline (BL): Day 1, pre-dose. A post-BL variant was defined as an amino acid substitution within HCV NS3/4A that was present after the first dose at virologic failure and follow-up visits but not at BL. Post-BL variant analysis was conducted for participants who did not achieve SVR24 who had sequence data available.|From Day 1 up to Follow-up Week 24 (up to 48 weeks total)|Treated non-SVR24 participants with BL and post-BL samples sequenced for RAVs.|||participants|||Number
2645480|NCT01710501|Secondary|Percentage of Subjects Achieving SVR24|HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR24 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 24 weeks after the end of all study therapy.|24 weeks after end of treatment (up to 48 weeks total)|Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.|||percentage of participants||95% Confidence Interval|Number
2645481|NCT01710501|Secondary|Percentage of Participants Achieving SVR4|HCV RNA was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR4 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 4 weeks after the end of all study therapy.|4 weeks after end of treatment (up to 28 weeks total)|Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.|||percentage of participants||95% Confidence Interval|Number
2645482|NCT01710501|Secondary|Percentage of Participants Achieving HCV RNA <25 IU/mL During Treatment by Time Point|HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL.|From TW 2 through end of treatment (up to 24 weeks)|Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.|||percentage of participants||95% Confidence Interval|Number
2645483|NCT01710501|Secondary|Percentage of Participants Achieving Undetectable HCV RNA During Treatment by Time Point|HCV RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay on blood samples drawn from each participant at Week 2, Week 4, Week 12, and at end of treatment. The assay has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. Undetectable HCV RNA was defined as HCV RNA < 9.3 IU/mL.|From Treatment Week (TW) 2 through end of treatment (up to 24 weeks)|Participants in the PP Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.|||percentage of participants||95% Confidence Interval|Number
2645500|NCT01710358|Secondary|Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Score ≤3.3|SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.|Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||percentage of participants|||Number
2645484|NCT01710501|Primary|Number of Participants Discontinued From Study Treatment Due to AEs During the Treatment Period and First 14 Follow-up Days|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.|Up to 24 weeks|APaT Population; all randomized participants who received at least one dose of study treatment.|||participants|||Number
2645485|NCT01710501|Primary|Number of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days|An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol -specified procedure, whether or not considered related to the medicinal product or protocol -specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.|14 days following last dose of study drug (up to 26 weeks)|All Participants as Treated (APaT) Population; all randomized participants who received at least one dose of study treatment.|||participants|||Number
2645486|NCT01710501|Primary|Percentage of Participants Achieving Sustained Virologic Response at 12 Weeks After the End of Treatment (SVR12)|Hepatitis C virus ribonucleic acid (HCV RNA) was measured using the Roche COBAS™ Taqman™ HCV Test, v2.0® assay, which has a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL. SVR12 was defined as HCV RNA <25 IU/mL (either target detected, unquantifiable or target not detected) 12 weeks after the end of all study therapy.|12 weeks after end of treatment (up to 36 weeks total)|Participants in the Per-Protocol (PP) Population (all randomized participants receiving ≥1 dose of study treatment and no important protocol deviation) with available data.|||percentage of participants||95% Confidence Interval|Number
2645487|NCT01710358|Secondary|Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib||Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 12; Week 24; Week 32: Pre-dose|All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.|||nanomole*hr/Liter (nmol*hr/L)||Geometric Coefficient of Variation|Geometric Mean
2645488|NCT01710358|Secondary|Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib||Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 12; Week 24; Week 32: Pre-dose|All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.|||nanomole/Liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2645489|NCT01710358|Secondary|Change From Baseline in Joint Space Narrowing (JSN) and Bone Erosion Scores|"X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.~The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints, with 0 indicating no erosion and the highest score (5 for the hand and 10 for the foot) indicating extensive loss of bone from more than one half of the articulating bone. Erosion scores ranged from 0 (no erosion) to 280 (high erosion)."|Baseline, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment. Missing values due to discontinuation of study, rescue, or missing data were imputed using LE.|||units on a scale||Standard Deviation|Mean
2645490|NCT01710358|Secondary|Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores|The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.|Baseline, Week 12, Week 24, Week 52|mITT population includes all randomized participants who received at least 1 dose of the study drug, with a baseline value and an observed value at the time point being summarized.|||percentage of impairment||Standard Deviation|Mean
2645491|NCT01710358|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)|A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.|Baseline, Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||millimeter||Standard Deviation|Mean
2645547|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Baseline|The baseline for CsA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|Screening, 0 hour (pre-dose) on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
2645492|NCT01710358|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores|European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.|Baseline, Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
2645493|NCT01710358|Secondary|Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)|The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.|Baseline, Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
2645494|NCT01710358|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores|"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue."|Baseline, Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.|||units on a scale||Standard Deviation|Mean
2645495|NCT01710358|Secondary|Mean Worst Joint Pain NRS in the Prior 7 Days as Collected in Electronic Diaries|"Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents no pain and 10 represents pain as bad as you can imagine. Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit was calculated."|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.|||units on a scale||Standard Deviation|Mean
2645496|NCT01710358|Secondary|Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries|"Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents no tiredness and 10 represents as bad as you can imagine. Participants reported their worst tiredness in electronic diaries. The average value across the 7 days preceding each visit is calculated."|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.|||units on a scale||Standard Deviation|Mean
2645497|NCT01710358|Secondary|Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries|"Participants rated the severity of their morning joint stiffness by selecting a number from 0 to 10 that best described their overall level of morning joint stiffness from the time they woke up, where 0 represents no joint stiffness and 10 represents joint stiffness as bad as you can imagine. Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit was calculated."|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.|||units on a scale||Standard Deviation|Mean
2645498|NCT01710358|Secondary|Median of Individual Participant Mean Duration of Morning Joint Stiffness in the Prior 7 Days as Collected in Electronic Diaries|Participants recorded the duration of their morning joint stiffness (MJS) in hours and minutes into electronic diaries daily. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit was calculated. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.|Week 12|mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.|||Minutes||95% Confidence Interval|Median
2645499|NCT01710358|Secondary|Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission|The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.|Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||percentage of participants|||Number
2645550|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 15|Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 15|Analysis population included all randomized participants who received at least 1 dose of study treatment.|||mg/L||Standard Deviation|Mean
2645501|NCT01710358|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score|The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.|Baseline, Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified last observation carried forward (mLOCF).|||units on a scale||Standard Deviation|Mean
2645502|NCT01710358|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response|"ACR50 and ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 and ACR70 Responder is a participant who has at least 50% or 70% improvement, respectively, in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP.~Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders."|Week 12, Week 24, Week 52|mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.|||percentage of participants|||Number
2645503|NCT01710358|Secondary|Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)|Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.|Baseline, Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.|||units on a scale||Standard Deviation|Mean
2645504|NCT01710358|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty (0 [without any difficulty], 1 [with some difficulty], 2 [with much difficulty], and 3 [unable to do]) when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.|Baseline, Week 12|mITT population includes all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified baseline observation carried forward (mBOCF).|||units on a scale||Standard Deviation|Mean
2645505|NCT01710358|Secondary|Change From Baseline in the Modified Total Sharp Score (mTSS)|"X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing for 44 and 42 joints, with higher scores representing greater damage.~The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448."|Baseline, Week 24|mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessments. Missing values due to discontinuation of study, rescue, or missing data were imputed using linear extrapolation (LE).|||units on a scale||Standard Deviation|Mean
2645506|NCT01710358|Primary|Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)|"ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis timepoint were deemed non-responders."|Week 12|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using nonresponder imputation (NRI).|||percentage of participants|||Number
2645507|NCT01710345|Primary|SPID-12|"The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point.~The SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-12 score is better."|12 hours||||units on a scale||Standard Error|Least Squares Mean
2645508|NCT01710332|Secondary|Change in Vision Based on Letter Score|• Mean change from baseline in best-corrected ETDRS (Early Treatment of Diabetic Retinopathy Study) letter score|6 months||||ETDRS letters||Standard Deviation|Mean
2645509|NCT01710332|Primary|Safety of Intravitreal Aflibercept Injection|Safety will be measured by the amount, significance and details of adverse events/reactions to the study drug.|6 months||||adverse events|||Number
2645551|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Day 8|Pro-drug MMF was metabolically converted to active form MPA in the liver. MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 8|Analysis population included all randomized participants who received at least 1 dose of study treatment.|||mg/L||Standard Deviation|Mean
2645510|NCT01710306|Secondary|Patient Activation Measure|The Patient Activation Measure (PAM) administered on line to RCT participants yields a patient activation score allowing comparison of patient activation with other populations/studies The PAM-13 item measures patient knowledge, skill, and confidence for medical self-management. It is scored on a scale from 0-100. These scores result in four levels of patient activation that range from 1 to 4 with 1 being the lowest level of patient activation for taking action and 4 the highest level of activation. Specifically: 1=believing the patient role is important. 2=having confidence/knowledge necessary to take action. 3=actually taking action to maintain/improve one's health. 4=maintaining health actions, even under stress. The percentage of participants in each arm who had a PAM score that indicated a level of activation/taking action (levels 3 and 4) will be identified.|Outcome measure was assessed at baseline data collection|Percentage of participants listed below are those in each arm who had a PAM score indicating a level of taking action (levels 3 and 4).|||Participants|||Count of Participants
2645511|NCT01710306|Primary|Number of Participants With VA Mental Health Care Engagement|VA mental health care engagement is defined as participation in any of the following: PTSD psychotherapy, cognitive processing therapy, or prolonged exposure therapy. To be identified in VA electronic medical record|Outcome measures are assessed at baseline interview and within 6 and 12 months following this semi-structured telephone interview .||||Participants|||Count of Participants
2645512|NCT01710254|Secondary|Accuracy of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD)|Determination of accuracy of Regadenoson stress-MRI in the detection of CAD, using x-ray angiography as the standard. Accuracy is the percentage of correctly classified subjects (true positive + true negative) among all subjects (true positive + true negative + false positive + false negative). Perfusion images interpreted by three blinded readers as normal or abnormal; majority results of the three blinded readers are reported.|one MRI, up to 1 hour|Results for 4 subjects are unevaluable due to delays in blinded reading of MRI scans and non-comparable due to personnel turnover in blinded MRI readers|||Percentage of correct total cases||95% Confidence Interval|Number
2645513|NCT01710254|Primary|Specificity of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD)|Determination of specificity of Regadenoson stress-MRI in the detection of CAD, using x-ray angiography as the standard. Perfusion images interpreted by three blinded readers as normal or abnormal; majority results of the three blinded readers are reported.|one MRI, up to 1 hour|Results for 4 subjects are unevaluable due to delays in blinded reading of MRI scans and non-comparable due to personnel turnover in blinded MRI readers|||Percentage of true negative cases||95% Confidence Interval|Number
2645514|NCT01710254|Primary|Sensitivity of Regadenoson Stress-MRI for Detection of Coronary Artery Disease (CAD)|Determination of sensitivity of Regadenoson stress-MRI in the detection of CAD, using x-ray angiography as the standard. Perfusion images interpreted by three blinded readers as normal or abnormal; majority results of the three blinded readers are reported.|one MRI, up to 1 hour|Results for 4 subjects are unevaluable due to delays in blinded reading of MRI scans and non-comparable due to personnel turnover in blinded MRI readers|||Percentage of true positive cases||95% Confidence Interval|Number
2645515|NCT01710137|Secondary|Point Prevalence Tobacco Abstinence|7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.|Week 18||||Participants|||Count of Participants
2645516|NCT01710137|Secondary|Time to 7-day Relapse|days to smoking regularly for 7 days|Week 24||||days||Standard Deviation|Mean
2645517|NCT01710137|Secondary|Continuous Abstinence to Week 24|No smoking between the quit day and the follow-up (Week 24).|Weeks 24||||Participants|||Count of Participants
2645518|NCT01710137|Secondary|Continuous Abstinence to Week 12|No smoking between the quit day and the follow-up (week 12).|Weeks 12||||Participants|||Count of Participants
2645519|NCT01710137|Secondary|Quality of Life at Week 12|The HIV/AIDS-Targeted Quality of Life scale measures overall functioning. Scale range from 7 - 35. Higher score indicates worse quality of life.|Week 12||||score on a scale||Standard Deviation|Mean
2645520|NCT01710137|Primary|Point Prevalence Tobacco Abstinence|7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.|Week 24||||Participants|||Count of Participants
2645521|NCT01710137|Primary|Point Prevalence Tobacco Abstinence|7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.|Week 12||||Participants|||Count of Participants
2645522|NCT01710046|Secondary|Percent Change From Baseline in TPSS by Visit|Target lesions were selected at baseline and followed for the duration of the study. Each target lesion was scored by the investigator on severity of erythema, induration, and scaling according to a 5-point (0 to 4) severity scale with a maximum sum score for a plaque of 12. The TPSS was calculated as the sum of the scores for erythema, induration, and scaling; the score can vary in increments of 1 unit from 0 to 12. A negative value indicated improvment.|Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.|||percent change from baseline||Standard Error|Mean
2645523|NCT01710046|Secondary|Target Plaque Severity Score (TPSS) by Visit|Target lesions were selected at baseline and followed for the duration of the study. Each target lesion was scored by the investigator on severity of erythema, induration, and scaling according to a 5-point (0 to 4) severity scale with a maximum sum score for a plaque of 12. The TPSS was calculated as the sum of the scores for erythema, induration, and scaling; the score can vary in increments of 1 unit from 0 to 12.|Baseline and Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.|||score on a scale||Standard Error|Mean
2645524|NCT01710046|Secondary|Change From Baseline in ISI by Visit|"ISI, a single-item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends. The baseline is defined as the average of all available diary entries before Baseline/Day 1 and the in-clinic measurement on Baseline/Day 1. Week 1 is the mean of daily values of study days 2 to 8 and Week 2 is the mean of daily values of study days 9 to 15. A negative value indicates an improvement."|Weeks 1, 2, 4 and 12|FAS; n=number of participants with nonmissing observations at the specified visit.|||units on a scale||Standard Error|Mean
2645613|NCT01709838|Secondary|Percentage of Participants With Baseline LIC>15 Achieving LIC<5 mg Fe/g dw|The percentage of participants with baseline LIC>15 mg Fe/g dw achieving an LIC <5 mg Fe/g dw during the study|5 years|The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug.|||percentage of participants|||Number
2645525|NCT01710046|Secondary|Itch Severity Item (ISI) Score by Visit|"The severity of itch (pruritus) due to psoriasis was assessed using the ISI, a single-item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends. the baseline is defined as the average of all available diary entries before Baseline/Day 1 and the in-clinic measurement on Baseline/day 1. Week 1 is the mean of daily values of study days 2 to 8 and Week 2 is the mean of daily values of study days 9 to 15."|Baseline and Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.|||units on a scale||Standard Error|Mean
2645526|NCT01710046|Secondary|Percent Change From Baseline in BSA|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.|Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.|||percent change from baseline||Standard Error|Mean
2645527|NCT01710046|Secondary|Change From Baseline in BSA|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.|Weeks 1, 2, 4, and 12|Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.||||||
2645528|NCT01710046|Secondary|Body Surface Area (BSA)|Assessment of BSA with psoriasis was performed separately for 4 body regions: head and neck, upper limbs, trunk (including axillae and groin), and lower limbs (including buttocks). The percent surface area with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (ie, the participant's fully extended palm, fingers and thumb together) represents approximately 1% of the total BSA. The number of handprints of psoriatic skin in a body region can be used to determine the extent (%) to which a body regions is involved with psoriasis. In each body region, the percent body region surface area with psoriasis is multiplied by the Body Region Weighting (head and neck=10%, upper limbs=5%, trunk [including axillae and groin]=3.33% and lower limbs [including buttocks]=2.5%). BSA (%)=0.1Sh + 0.2Sh+0.3St+0.4Sl, where S=body region suface area with psoriasis: h=head; u=upper limbs; t=trunk; l=lower limbs.|Baseline and Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.|||% BSA||Standard Error|Mean
2645529|NCT01710046|Secondary|Percentage of Participants by PGA Response Category and Timepoint|PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). Response category scores: 0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe. The severity scores of 3 components (erythema, induration, and scaling) are averaged and rounded to the nearest whole number to determine the PGA score.|Baseline and Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.|||percentage of participants|||Number
2645530|NCT01710046|Secondary|Percentage of Participants in Each PGA Category at Various Timepoints by Baseline Category||Baseline and Weeks 1, 2, 4, and 12|Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.||||||
2645531|NCT01710046|Secondary|Change From Baseline in PGA Score by Visit|PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). The severity scores of 3 components (erythema, induration, and scaling) are averaged and rounded to the nearest whole number to determine the PGA score.|Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.|||units on a scale||Standard Error|Mean
2645532|NCT01710046|Secondary|Percentage of Participants Achieving a PASI75 Response at Weeks 1, 2, and 4|Combined assessment of lesion severity and area affected into single score; range=0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.|Weeks 1, 2, and 4|FAS|||percentage of participants|||Number
2645533|NCT01710046|Secondary|Percent Change From Baseline in PASI by Visit|"Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90â€100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease."|Weeks 1, 2, 4, and 12|FAS; n=number of participants with nonmissing observations at the specified visit.|||percent change from baseline||Standard Error|Mean
2645534|NCT01710046|Secondary|Change From Baseline in PASI by Visit|"Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0=0% to 6=90â€100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease."|Weeks 1, 2, 4 and 12|Because Cohort 2 of the study was not conducted and Cohort 1 had a limited number of participants, the analyses were simplified and this analysis was not performed.||||||
2645535|NCT01710046|Secondary|Psoriasis Area and Severity Index (PASI) Score by Visit|"Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0=0% to 6=90â€100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4) summed over all sections; total possible score range: 0= no disease to 72= maximal disease."|Baseline and Weeks 1, 2, 4, and 12|FAS; n (number) =number of participants with nonmissing observations at the specified visit.|||units on a scale||Standard Error|Mean
2645536|NCT01710046|Primary|"Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 12"|PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). â€˜Clearâ€™ and â€œAlmost clearâ€™ includes all participants who were scored as a 0 or 1.|Week 12|FAS|||percentage of participants|||Number
2645537|NCT01710046|Primary|Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12|Combined assessment of lesion severity and area affected into single score; range equals (=) 0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.|Week 12|FAS|||percentage of participants|||Number
2645538|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Day 57|TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 57|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
2645539|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Day 29|TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
2645540|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Day 15|TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 15|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
2645541|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Day 8|TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 8|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
2645542|NCT01710033|Primary|Tacrolimus (TAC) Plasma Trough Concentration at Baseline|The baseline for TAC trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). TAC levels were assessed at different visits to assess change in TAC trough levels due to CP-690,550 exposure.|Screening, 0 hour (pre-dose) on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
2645543|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Day 57|CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 57|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
2645544|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Day 29|CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
2645545|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Day 15|CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 15|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
2645546|NCT01710033|Primary|Cyclosporine (CsA) Plasma Trough Concentration at Day 8|CsA levels were assessed at different visits to assess change in CsA trough levels due to CP-690,550 exposure.|0 hour (pre-dose) on Day 8|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
2646249|NCT01704976|Secondary|Isometric Rate of Force Development (IRFD) Left Knee-extensor|It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.|after 4 weeks||||Newton/seconds||Inter-Quartile Range|Median
2645552|NCT01710033|Primary|Mycophenolic Acid (MPA) Plasma Trough Concentration at Baseline|Pro-drug MMF was metabolically converted to active form MPA in the liver. The baseline for MPA trough concentrations was defined as the average of the values obtained at Screening and on Day 1 (pre-dose). MPA levels were assessed at different visits to assess change in MPA trough levels due to CP-690,550 exposure.|Screening, 0 hour (pre-dose) on Day 1|Analysis population included all randomized participants who received at least 1 dose of study treatment.|||Milligram per Liter (mg/L)||Standard Deviation|Mean
2645553|NCT01710033|Primary|Plasma Decay Half-Life (t1/2) at Steady State For CP-690,550|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half at steady state.|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||hours||Standard Deviation|Mean
2645554|NCT01710033|Primary|Plasma Decay Half-Life (t1/2) For CP-690,550|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||hours||Standard Deviation|Mean
2645555|NCT01710033|Primary|Accumulation Ratio (Rac) For CP-690,550|Rac obtained from AUC(0-12) (Day 29) divided by AUC(0-12) (Day 1).|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1 and 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ratio||Standard Deviation|Mean
2645556|NCT01710033|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State For CP-690,550||0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||hours||Full Range|Median
2645557|NCT01710033|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) For CP-690,550||0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||hours||Full Range|Median
2645558|NCT01710033|Primary|Maximum Observed Plasma Concentration (Cmax) at Steady State For CP-690,550||0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng/mL||Standard Deviation|Mean
2645559|NCT01710033|Primary|Maximum Observed Plasma Concentration (Cmax) For CP-690,550||0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2645560|NCT01710033|Primary|Area Under the Curve From Time Zero to 12 Hour Concentration [AUC(0-12)] at Steady State For CP-690,550|Area under the plasma concentration time-curve from zero to 12 hour concentration [AUC(0-12)] at steady state.|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng*hr/mL||Standard Deviation|Mean
2645561|NCT01710033|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) at Steady State For CP-690,550|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state.|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12, 24 hours post-dose on Day 29|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||ng*hr/mL||Standard Deviation|Mean
2645562|NCT01710033|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) For CP-690,550|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 2, 4, 8, 10, 12 hours post-dose on Day 1|"Analysis population included all randomized participants who received at least 1 dose of study treatment. Here N (Number of Participants Analyzed) signifies participants who were evaluable for this measure."|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
2645563|NCT01710020|Other Pre-specified|Dialyser Clearance (CL HD) From 3 to 3.5 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|3 to 3.5 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/min||Standard Deviation|Mean
2645564|NCT01710020|Other Pre-specified|Overall Dialyser Clearance (CL HD)|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|0 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/min||Standard Deviation|Mean
2645565|NCT01710020|Secondary|Fraction of Unbound Drug (fu)|Fraction of unbound drug (fu) is defined as the ratio of unbound drug concentration to the total drug concentration.|2 hours post-dose in Period 1|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ratio||Standard Deviation|Mean
2645614|NCT01709838|Primary|Absolute Change in Liver Iron Content (LIC) at 52 Weeks From Baseline|Absolute change in liver iron concentration measured by MRI from baseline after 52 weeks of treatment|Baseline, 52 weeks|The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug.|||mg Fe/g dw||Standard Deviation|Mean
2645566|NCT01710020|Primary|Dialyser Clearance (CL HD) From 3 to 4 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|3 to 4 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/min||Standard Deviation|Mean
2645567|NCT01710020|Primary|Dialyser Clearance (CL HD) From 2 to 3 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|2 to 3 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/min||Standard Deviation|Mean
2645568|NCT01710020|Primary|Dialyser Clearance (CL HD) From 1 to 2 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|1 to 2 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/min||Standard Deviation|Mean
2645569|NCT01710020|Primary|Dialyser Clearance (CL HD) From 0 to 1 Hour|Dialyser clearance was calculated as amount of drug in dialysate collected over a period of time (AHD) divided (/) by the product of fraction unbound of drug in plasma (fu), corresponding mid-time plasma concentration of drug (Cmid), and duration of dialysate collection period (tm). CL HD = AHD/(fu*Cmid*tm).|0 to 1 hrs during hemodialysis started 4 hrs post-dose in Period 2|Analysis set included all participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mL/min||Standard Deviation|Mean
2645570|NCT01710020|Primary|Oral Clearance (CLpo)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing given dose of drug with AUC.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.|||milliliter/minute (mL/min)||Standard Deviation|Mean
2645571|NCT01710020|Primary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.|||hr||Standard Deviation|Mean
2645572|NCT01710020|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.|||hr||Full Range|Median
2645573|NCT01710020|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2645574|NCT01710020|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hrs post-dose in Period 1|Analysis set included all participants who received study medication.|||ng*hr/mL||Standard Deviation|Mean
2645575|NCT01710020|Primary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]|AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24 hours (hrs) post-dose in Period 1|Analysis set included all participants who received study medication.|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Mean
2645576|NCT01709903|Secondary|Symptoms Reported Using E-diary Over 12 and 26 Weeks of Treatment|Percentage of nights with 'no nighttime awakenings', percentage of days with 'no daytime symptoms', and percentage of 'days able to perform usual daily activities' over 26 weeks (FAS)|26 weeks|Full Analysis Set|||% days in study||Standard Error|Least Squares Mean
2645577|NCT01709903|Secondary|Rescue Medication Use: Summary of the Mean Daily, Daytime and Nighttime Number of Puffs of Rescue Medication, by 4 Weekly Intervals|"The number of puffs of rescue medication taken in the previous 12 hours will be recorded in the Patient Diary in the morning and evening. Baseline 12 weeks and Baseline 26 weeks, were the baseline scores for available participants analyzed for each time point. Less puffs taken is better."|12 and 26 weeks|Full Analysis set|||# of puffs||Standard Deviation|Mean
2645578|NCT01709903|Secondary|Analysis of the TDI Focal Score Over the Whole Treatment Period|"The Transition Dyspnea Index (TDI) total score after 12 and 26 weeks of treatment will be analyzed using the same mixed model as specified for the primary analysis with the Baseline Dyspnea Index (BDI) total score as the baseline.Total score ranging - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea. One additional option in each category, which does not contribute to the score, allows for circumstances in which impairment is due to reasons other than dyspnea. .Baseline 12 weeks and Baseline 26 weeks, were the baseline scores for available participants analyzed for each time point."|12 and 26 weeks|Full Analysis Set|||Numbers on a scale||Standard Error|Least Squares Mean
2645591|NCT01709864|Secondary|"Percentage of Nights With no Nighttime Awakenings"|"Patients are reporting symptoms by using an electronic diary. A night with no nighttime awakening is defined from diary data as any night where the patient did not wake up due to symptoms. Percentage of no nighttime awakenings from Baseline up to 12 weeks."|from Baseline up to 12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||percentage of nights||Standard Error|Least Squares Mean
2645640|NCT01709695|Primary|Go/No-go Task Performance Correct Inhibitions|Measures of go/no-go task performance during functional magnetic resonance imaging. Performance on a go-nogo task inside the scanner.|Baseline and 8 weeks||||percentage correct inhibitions||Standard Deviation|Mean
2645579|NCT01709903|Secondary|Health Related Quality of Life Analysis of SGRQ Total Score After 26 Weeks of Treatment|A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.|26 weeks|Full Analysis set|||numbers on a scale||Standard Error|Mean
2645580|NCT01709903|Secondary|Analysis of Trough FVC (L) Over the Whole Treatment Period|Average of Trough Forced Vital Capacity (FVC) at 23 hours 15 min and the 23 hours 45 min post dose|12 and 26 weeks|Full Analysis Set|||liter||Standard Error|Least Squares Mean
2645581|NCT01709903|Secondary|Analysis of FEV1 (L) Trough Response (Pre-dose) Over the Whole Treatment Period|Average of Trough Forced Expiratory Volume in one second (FEV1)|6,12,18 and 26 weeks|Full analysis set|||liter||Standard Error|Least Squares Mean
2645582|NCT01709903|Secondary|Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-4 Hours|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4h at Day 1 was measured via spirometry conducted according to internationally accepted standards. Measurements were made at 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. Mixed model used: AUC FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.|Day 1, 12 and 26 weeks|Full Analysis set|||Liter||Standard Deviation|Mean
2645583|NCT01709903|Secondary|Trough Forced Expiratory Volume in One Second (FEV1) Following 26 Weeks of Treatment to Demonstrate the Superiority of QVA 110/50μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d||26 weeks|FAS|||liters||Standard Error|Least Squares Mean
2645584|NCT01709903|Primary|Trough Forced Expiratory Volume in One Second (FEV1) Following 26 Weeks of Treatment to Demonstrate the Non-inferiority of QVA149 110/50 μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d|Measurement of QVA149 110/50 μg o.d. to fluticasone/salmeterol 500/50 μg b.i.d. in terms of trough FEV1 (mean of 23 h 15 min and 23 h 45 min post QVA149 dose) following 26 weeks of treatment in patients with moderate to severe COPD.|26 weeks|FAS|||liters||Standard Error|Least Squares Mean
2645585|NCT01709864|Secondary|Change From Baseline of Forced Expiratory Volume in One Second (FEV1) at All Individual Timepoints at Day 1 and at Week 12 (Day 85)|The Forced Expiratory Volume in one second (FEV1) assessments for all individual time points of the serial measurements on day 1 and at week 12 are analyzed.|Baseline, Day 1 and Week 12 (Day 85)|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||liters||Standard Error|Least Squares Mean
2645586|NCT01709864|Secondary|Change From Baseline of Forced Vital Capacity (FVC) at All Individual Timepoints at Day 1 and at Week 12 (Day 85)|The Forced Vital Capacity (FVC) assessments for all individual time points of the serial measurements on day 1 and at week 12 are analyzed.|Baseline, Day 1 and Week 12 (Day 85)|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||liters||Standard Error|Least Squares Mean
2645587|NCT01709864|Secondary|Percentage of Days Without Rescue Medication Use|Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. The use of rescue medication is analyzed as the percentage of days without usage of rescue medication over the 12 weeks treatment period. The baseline is calculated from the run-in epoch prior to randomization.|12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12|||percentage of days||Standard Error|Least Squares Mean
2645588|NCT01709864|Secondary|The Average Number of Puffs of Rescue Medication Per Day|Patients report the number of puffs of rescue medication (salbutamol / albuterol) using an electronic diary. The use of rescue medication is analyzed as the mean daily number of puffs used per patient over the 12 weeks treatment period.|baseline and 12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12|||number of puffs||Standard Error|Least Squares Mean
2645589|NCT01709864|Secondary|"Percentage of Days Able to Perform Usual Daily Activities"|"Patients are reporting symptoms by using an electronic diary. A day able to perform usual daily activities is defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms."|from Baseline up to 12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||pecentage of days||Standard Error|Least Squares Mean
2645590|NCT01709864|Secondary|"Percentage of Days With no Daytime Symptoms"|"Patients are reporting symptoms by using an electronic diary. A day with no daytime symptoms is defined from diary data as any day where the patient has recorded in the evening no cough, no wheeze, no production of sputum, and no feeling of breathlessness (other than when running) during the past approximately 12 hours. The percentage of days is calculated by the number of days with no daytime symptoms/total number of days with evaluable data X 100."|from Baseline up to 12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug. Following the intent-to -treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||percentage of days||Standard Error|Least Squares Mean
2645592|NCT01709864|Secondary|Change From Baseline of Morning and Nighttime Symptom Scores at Week 12|Patients reported symptoms using an electronic diary.The diary has 9 symptom questions each am & each pm.Each question can be answered w/1 of 4 pre-defined answers,with a unit value of 0-3, 0 is least & 3 is most severe symptom.Symptom scores are calculated as the mean of the symptom scores(either the score assessed in am for the previous 12 hrs-referred to as nighttime scores,or the score assessed in pm for the previous 12 hrs-referred to as the daytime symptom score) for each patient over 12 weeks.The baseline is calculated from the run-in epoch prior to randomization.The change from baseline is in LS mean daily symptom scores over the 12 weeks. If the mean score over the 12 weeks is lower than the baseline, result is (-).A neg. result indicates an improvement in COPD symptom severity. the # of patients analyzed can vary between both day & night scores. Therefore, the # of patients analyzed for the combined daily symptom score can vary from the #s for individual day & night scores.|12 weeks|Participants from the full analysis set (FAS), who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed only and included all randomized patients who received at least one dose of study drug.|||score||Standard Error|Least Squares Mean
2645593|NCT01709864|Secondary|Change From Baseline of Daily Symptom Scores|Patients reported symptoms using an electronic diary.The diary has 9 symptom questions each am and each pm. Each question can be answered w/1 of 4 pre-defined answers, with a unit value of 0-3, 0 is least & 3 is most severe symptom.Symptom scores are calculated as the mean of combined daily symptom scores(combined from am & pm)for each patient over 12 weeks. The baseline is calculated from the run-in epoch prior to randomization.The change from baseline is in LS mean daily symptom scores over the 12 weeks. If the mean score over the 12 weeks is lower than the baseline, result is (-).A neg. result indicates an improvement in COPD symptom severity. Patients may have met the min. response requirements for the night scores(am questions),but not for the day scores(pm questions)or vice versa, the # of patients analyzed can vary between both day & night scores. Therefore, the # of patients analyzed for the combined daily symptom score can vary from the #s for individual day & night scores.|12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.|||Score||Standard Error|Least Squares Mean
2645594|NCT01709864|Secondary|Breathlessness Assessed by Transition Dyspnea Index (TDI) Focal Score at Week 12|Breathlessness at week 12 is measured using the Transition Dyspnea Index (TDI). On day 1, breathlessness is assessed by the Baseline Dyspnea Index (BDI). Patients are considered to have clinically significant improvement with the TDI score change versus BDI being equal to or greater than 1. TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score.|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12|||scores on a scale||Standard Error|Least Squares Mean
2645595|NCT01709864|Secondary|Percentage of Participants With a Clinically Important Improvement of >=4units in the SGRQ Total Score at Week 12|The health status, as reported by the patients, is assessed using the St. George's Respiratory Questionnaire (SGRQ). The assessment is based on total score as well as the percentage of patients with clinically significant improvement at week 12 versus day 1. A clinically significant improvement in SGRQ is defined as less than or equal to -4 change from baseline.|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.|||percentage of participants|||Number
2645596|NCT01709864|Secondary|Change From Baseline in the Health Status Assessed by St. George's Respiratory Questionnaire|The health status, as reported by the patients, is assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ is a 50 item scale assessing symptoms, patient activities and impact of the disease. Scores range from 0 to 100 units, with higher scores indicating more limitations. The assessment is based on total score as well as the percentage of patients with clinically significant improvement at week 12 versus day 1. A clinically meaningful improvement (MCID) in SGRQ is defined as a decrease of 4 or more units of the SGRQ scale in the total score, as compared to baseline (change from baseline).|Week 12|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Week 12|||score||Standard Error|Least Squares Mean
2645597|NCT01709864|Secondary|Change From Baseline in FEV1 AUC (0-12H) at Day 1 and FEV1 AUC (0-4h), AUC (4-8h), AUC (8-12h) at Day 1 and Week 12 (Day 85)|The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) is assessed for different time spans within the overall serial measurement post dosing (FEV1 AUCs Time Spans), at day 1 and at week 12 of treatment. Serial lung function measurements are taken at various time points post dosing on day 1 and at week 12 to calculate the AUC for these different time spans.|Day 1 and Week 12 (Day 85)|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. Day 1and Week 12|||liters*hr||Standard Error|Least Squares Mean
2645598|NCT01709864|Secondary|Change From Baseline in Trough FEV1 and Pre-dose Trough FEV1 by Visit|Trough Forced Expiratory Volume in one second (FEV1) is the mean of FEV1 at 23h 15min and 23h 45min after the morning dose of the previous day. Pre-dose trough FEV1 is the mean of FEV1 at -45min and -15min before morning dose|Day 2, 86 (trough) Day 15, 29, 57, 85 (pre-dose trough)|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.|||liters||Standard Error|Least Squares Mean
2646250|NCT01704976|Secondary|Isometric Rate of Force Development (IRFD) Right Knee-extensor|It will be evaluated by isometric RFD (Newton/seconds) at 90 degree angle in the knee joint.|after 4 weeks||||Newton/seconds||Inter-Quartile Range|Median
2645599|NCT01709864|Primary|Change From Baseline of Standardized Area Under the Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) Post Dosing|The standardized Area Under the Curve (AUC) for Forced Expiratory Volume in one second (FEV1) post dosing (FEV1 AUC) at week 12 of treatment. Serial lung function measurements are taken at various time points following dosing at week 12 to calculate the AUC.|12 weeks|The full analysis set (FAS): all randomized patients who received at least one dose of trial drug, patients were analyzed according to the treatment they were assigned to at randomization. analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12|||liters*hr||Standard Error|Least Squares Mean
2645600|NCT01709838|Secondary|Plasma Pharmacokinetics (PK) Deferasirox Concentrations|Blood samples for PK evaluation were collected for a sub-group of patients. The patient had to have been on treatment without dose adjustment or treatment interruption (for any reason) for at least 4 consecutive days prior to scheduled PK sampling visit. If there was a dosage change or interruption within 4 days of the visit, no PK blood samples was collected, and an appropriate comment had to be made on the PK CRF page.|Weeks 12 & 24: pre-dose (0hr), 2hr & 4hr post-dose|The PK analysis set consisted of all patients from FAS who had evaluable PK data.|||hr*umol/L||Geometric Coefficient of Variation|Geometric Mean
2645601|NCT01709838|Secondary|PK Parameters: Tmax|The pharmacokinetic parameter, Tmax, may be determined using non-compartmental method(s) for deferasirox and its iron complex. Tmax=time to reach maximum/peak concentration following drug administration.|pre-dose (0 hour), and at 2, and 4 hours at Week 4|The PK analysis set consisted of all patients from FAS who had evaluable PK data.|||hr||Geometric Coefficient of Variation|Geometric Mean
2645602|NCT01709838|Secondary|PK Parameters: Cmax|The pharmacokinetic parameter, Cmax, was determined using non-compartmental method(s) for deferasirox and its iron complex. Cmax (maximum/peak plasma drug concentration after drug administration)=amount × volume|pre-dose (0 hour), and at 2, and 4 hours at Week 4|The PK analysis set consisted of all patients from FAS who had evaluable PK data.|||umol/L||Geometric Coefficient of Variation|Geometric Mean
2645603|NCT01709838|Secondary|PK Parameters: AUCtau|The pharmacokinetic parameter, AUCtau was determined using non-compartmental method(s) for deferasirox and its iron complex. AUC=area under the concentration-time curve during a dosing interval at steady state (amount × time × volume).|pre-dose (0 hour), and at 2, and 4 hours at Week 4|The PK analysis set consisted of all patients from FAS who had evaluable PK data.|||hr*umol/L||Geometric Coefficient of Variation|Geometric Mean
2645604|NCT01709838|Secondary|Absolute Change in Serum Ferritin From Baseline After 52 Weeks|Absolute change in serum ferritin from baseline after 52 weeks of treatment|Baseline, 52 weeks|The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug.|||ng/mL||Standard Deviation|Mean
2645605|NCT01709838|Secondary|Absolute Change in LIC From Baseline After 52 Weeks of Treatment by Underlying Non-transfusion Dependent Thalassemia (NTDT) Syndrome|Absolute change in liver iron concentration measured by MRI from baseline after 52 weeks of treatment by underlying NTDT syndrome. The 4 underlying disease types: Beta-thalassemia intermedia (N =69), HbE beta-thalassemia (N = 24), Alpha-thalassemia intermedia (HbH disease) (N = 40), Other, specify (N = 1)|Baseline, 52 Weeks|The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug.|||mg Fe/g dw||Standard Deviation|Mean
2645606|NCT01709838|Secondary|Correlation Analysis for Absolute Change in LIC and Serum Ferritin at Week 24 and EOS (Week 260 + 30 Days Follow-up)|Correlation for absolute change between LIC and serum ferritin was assessed using scatter plots with pearson correlation coefficient and simple linear model.|Week 24, End of Study (EOS): Week 260 + 30 days follow up|The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug.|||correlation coefficient|||Number
2645607|NCT01709838|Secondary|Serum Ferritin (SF) vs LIC at Baseline and EOS (Week 260 + 30 Days Follow-up)|Correlation between serum ferritin and LIC is assessed using scatter plots with pearson correlation coefficient and simple linear model.|Baseline, End of Study (EOS): Week 260 + 30 days follow up|The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug.|||correlation coefficient|||Number
2645608|NCT01709838|Secondary|Absolute Change in LIC From Baseline Over Time|Absolute change in serum ferritin from baseline over time up to 260 weeks|24, 52, 76, 104, 128, 156, 180, 208, 232, 260 Weeks|The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug.|||mg Fe/g dw||Standard Deviation|Mean
2645609|NCT01709838|Secondary|Absolute Change in Health-related Outcomes Using the Pediatric Quality of Life Questionnaire (PedsQL™)|The PedsQL™ is a modular approach to measuring health-related quality of life (HRQOL) in children and adolescents. The 23-item PedsQL™ Generic Core Scales encompass the essential core domains for pediatric HRQOL measurement: 1) Physical Functioning (8 items), 2) Emotional Functioning (5 items), 3) Social Functioning (5 items), and 4) School Functioning (5 items). The Generic Core Scales are designed to enable comparisons across patient and healthy populations. The higher values indicate a better evaluation of health. Range: 0 to 100 [0 (worst possible health state measured by the questionnaire) to 100 (best possible health state)].|Baseline, 52, 104 & 156 Weeks|The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug.|||scores on a scale||Standard Deviation|Mean
2645610|NCT01709838|Secondary|Absolute Change in Health-related Outcomes Using Medical Outcomes Study Form 36 (SF-36v2)|The SF-36 is a self-administered questionnaire for adults (from 18 years of age) and contains 36 items which measure: Physical functioning, Role limitation due to physical health problems, Bodily pain, General health perceptions, Vitality, Social functioning, Role limitations due to emotional problems and General mental health . The higher values indicate a better evaluation of health. Range: 0 to 100 [0 (worst possible health state measured by the questionnaire) to 100 (best possible health state)].|Baseline, 52, 104 & 156 Weeks|The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug.|||scores on a scale||Standard Deviation|Mean
2645611|NCT01709838|Secondary|Time From Target LIC of 3 mg Fe/g dw to the First LIC ≥5 mg Fe/g dw in the Follow up Period|Time from the target LIC <3 mg Fe/g dw to the first LIC ≥5 mg Fe/g dw in the follow-up period|post-baseline, up to 260 weeks|The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug.|||days||95% Confidence Interval|Median
2645612|NCT01709838|Secondary|Time to Achieving LIC <5 mg Fe/g dw|Time to achieving LIC <5 mg Fe/g dw for participants with baseline LIC>15 mg Fe/g dw during the study|5 years|The Full Analysis Set (FAS) consisted of all patients who were assigned at least one dose of study drug.|||months||95% Confidence Interval|Median
2645615|NCT01709799|Secondary|Timed Instrumental Activities of Daily Living Task|"The TIADL consists of five timed instrumental activities of daily (TIADL) tasks. The score that is generated is the total time required to perform the tasks (e.g., finding a telephone number, making change, finding and reading the ingredients on a can of food, finding food items on a shelf, reading instructions on medicine container). Thus LOWER SCORES are indicative of IMPROVEMENT.~These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:~T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)||||T-score units||Standard Error|Mean
2645616|NCT01709799|Primary|Sweep Seeker Subtest of PositScience Insight|"Participants watch two patterns that sweep in or out and identify their direction. The test measures visual processing speed. As participants master the task it is made more difficult via: (a) the colors of the sweeps change, (b) the direction of the sweeps change, and (c) the thickness of the bars change. Participants' scores are in milliseconds. As participants improve, the visual sweeps speed up, giving participants a lower (better) score. Thus LOWER SCORES are indicative of IMPROVEMENT.~These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:~T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)||||T-score units||Standard Error|Mean
2645617|NCT01709799|Primary|Road Tour Subtest of PositScience Insight|"Participants choose which car they saw at the center of the screen, and also locate where a Route 66 sign appeared in the periphery. This is a measure of useful field of view and visual processing speed. As participants master the task, it is made more difficult via: (a) distractors are added, (b) distance from the center increases, (c) cars get more similar, and (d) backgrounds get more complex. Score is in milliseconds. As participants improve, the cars and road signs flash for fewer milliseconds, giving them a lower (better) score. Thus LOWER SCORES are indicative of IMPROVEMENT.~These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:~T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)||||T-score units||Standard Error|Mean
2645618|NCT01709799|Primary|Master Gardener Subtest of PositScience Insight|"Participants watch as three or five images briefly flash in different positions on screen. This task measures visual processing speed and visual working memory. As participants master the task, it is made more difficult via: (a) the images change, becoming more similar, (b) the images are shown over a larger area on screen, and (c) participants go from viewing 3 images to 5 images. Participant score is in milliseconds, so that as they improve, the images flash on screen for fewer milliseconds. Thus LOWER SCORES are indicative of IMPROVEMENT.~These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:~T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)||||T-score units||Standard Error|Mean
2645619|NCT01709799|Primary|Jewel Diver Subtest of PositScience Insight|"Participants track target objects as they move around the screen. This is a measure of divided attention. As participants master the task, it is made more difficult in that: (a) objects travel more quickly, (b) objects travel over larger area, (c) objects travel for longer, (d) visual contrast decreases. The score is the number of objects participants are able to track. Thus, HIGHER SCORES reflect IMPROVEMENT~These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:~T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)||||T-score units||Standard Error|Mean
2645620|NCT01709799|Primary|Bird Safari Subtest of PositScience Insight|"Participants identify the bird that is different from the others as it flashes briefly on screen. The test measures visual speed and precision. The test is adaptive, and becomes more difficult with practice in that bird pairs get more similar, backgrounds get more complex, and distance from the center increases. The raw score is in milliseconds. As participants improve, the birds flash for fewer milliseconds, giving them a lower (better) score. Thus, LOWER SCORES reflect IMPROVEMENT~These scores have been converted to T-scores (standardized scores with an average of 50 and standard deviation of 10). The formula used was:~T-score = ((((participant score minus sample mean at baseline) / (sample standard deviation at baseline) ) * 10) + 50)"|Baseline (Week 0), immediate posttest (Week 16), delayed posttest (Week 28)||||T-score units||Standard Error|Mean
2645621|NCT01709786|Primary|CBC Hemoglobin Measurement Compared to Non-invasive iSTAT Measurement|"When blood was drawn for laboratory measurement of serum hemoglobin, one drop of blood was used to make point of care measurements using the CBC and iSTAT methods.~For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table."|n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.||||grams per deciliter||95% Confidence Interval|Mean
2645622|NCT01709786|Primary|CBC Hemoglobin Measurement Compared to Non-invasive Radical-7 Measurement|"Whenever blood was drawn for laboratory measurement of serum hemoglobin, we used one drop of blood to make point-of-care measurements using the CDC and Radical-7 methods.~For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table."|n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.||||grams per deciliter||95% Confidence Interval|Mean
2645623|NCT01709708|Secondary|Overall Satisfaction|Satisfaction scores Visit 2 vs. following treatment (Treatment 12) and at 1-Month Post-Treatment (Group A vs. Group B). Satisfaction scores are a likert scale ranging from 1 to 5 with 1 being complete dissatisfaction and 5 being complete satisfaction.|10 Weeks||||units on a scale||Standard Deviation|Mean
2645708|NCT01709500|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.|||percent change||Standard Error|Least Squares Mean
2645624|NCT01709708|Secondary|Headache Impact Test (HIT-6)|"Total Headache Impact Test (HIT-6) scores Pre-Treatment at Visit 2 vs. Post-Treatment (following final treatment), and at 1-Month Post-Treatment (Group A vs. Group B). HIT-6 is a series of 6 likert scale questions ranging from 1 to 5 with 1 being never and 5 being always. The HIT-6 answer options are weighted as follows: Never (1) = 6 points each, Rarely (2) = 9 points each, Sometimes (3) = 10 points each, Very often (4) = 11 points each, Always (5) = 13 points each. The total score for the HIT-6 ranges from 36 (subject answers all 6 questions as Never) to 78 subject answers all 6 questions as Always), with higher total scores indicating more impact than lower scores, i.e., headaches cause greater impact on the subject's life."|10 Weeks||||units on a scale||Standard Deviation|Mean
2645625|NCT01709708|Secondary|Adverse Events|Number of adverse events over the entire length of study (Group A vs. Group B).|34 weeks||||Number of Adverse Events||Standard Deviation|Mean
2645626|NCT01709708|Secondary|Acute Medications Usage|Number of acute medications used during Treatment period (6 weeks) and Follow-Up (4 weeks) (Group A vs. Group B).|10 Weeks||||Number of medications used||Standard Deviation|Mean
2645627|NCT01709708|Secondary|Migraine Headache Days|Compare change in the number of migraine headache days per month reported in Baseline Period Diary vs. Treatment Period Diary vs. Post-Treatment Period Diary.|12 Weeks||||Migraine headache days per month||Standard Deviation|Mean
2645628|NCT01709708|Secondary|Modified Pain Characteristic Questionnaire|Compare Modified Pain Characteristic Questionnaire scores Before Procedure vs. 24-Hour After Procedure, Before Procedure vs. 1-Month Follow Up, and Before Procedure vs. 6-Month Follow Up (Mean of all 12 treatments for each timepoint, comparing Group A to Group B). The modified pain characteristic questionnaire is a series of 11 questions on a likert scale ranging from 0 to 10 with 0 being no pain or does not interfere and 10 being worst pain or completely interferes. Percentage questions range from 0 to 100.|Before Treatment, 24 Hours After Treatment, 1 Month Post Treatment, and 6 Months Post Treatment||||units on a scale||Standard Deviation|Mean
2645629|NCT01709708|Secondary|Patient's Global Impression of Change (PGIC)|Compare 24-Hour After Procedure Patient's Global Impression of Change (PGIC) score for 12 treatments (Mean of all 12 treatments for each timepoint, comparing Group A to Group B). PGIC is a likert scale ranging from 1 to 7 with 1 being very much improved and 7 being very much worse.|30 minutes Post Treatment and 24 hours Post Treatment, assessed up to 6 weeks||||units on a scale||Standard Deviation|Mean
2645630|NCT01709708|Secondary|Change in Numeric Rating Scale (NRS)|Compare percentage change in Numeric Rating Scale (NRS) score from Before Procedure to 15-Minutes, Before Procedure to 30-Minutes, Before Procedure to 24-Hours After Procedure for all 12 treatments (Mean of all 12 treatments for each timepoint, comparing Group A to Group B). NRS is a likert scale ranging from 0-10 with 0 being no pain and 10 being worst possible pain.|15 Minutes Post Treatment, 30 minutes Post Treatment and 24 hours Post Treatment, assessed up to 6 weeks||||percentage of change||Standard Deviation|Mean
2645631|NCT01709708|Primary|Numeric Rating Scale (NRS)|Compare Numeric Rating Scale (NRS) scores Before Procedure,15-Minute Post Treatment, 30-Minutes Post Treatment, 24-Hour Post Treatment for all 12 treatments (Marcaine vs. Saline). NRS is a likert scale ranging from 0-10 with 0 being no pain and 10 being worst possible pain. For each individual time point, all 12 treatments were averaged for that time point and a single value was used for comparison between the two groups.|6 Weeks||||units on a scale||Standard Deviation|Mean
2645632|NCT01709695|Primary|Go/No-go Task Performance Correct Responses|Measures of go/no-go task performance during functional magnetic resonance imaging. Performance on a go-nogo task inside the scanner.|Baseline and 8 weeks||||percentage correct responses||Standard Deviation|Mean
2645633|NCT01709695|Secondary|Continuous Performance Test - Commissions|Neuropsychological assessment - Continuous Performance Test - Commissions. CPT is a task-oriented computerized assessment of attention-related problems. Scores are compared with the normative scores for the age, group and gender of the person being tested. A t-score of 50 is equal to the mean, with higher values indicating more problematic behaviors and lower scores indicating less problematic behaviors.|Baseline||||t-scores||Standard Deviation|Mean
2645634|NCT01709695|Secondary|Attention Deficit Hyperactivity Disorder Rating Scale IV (ADHDRS IV)|Norm referenced parent interview to assess severity and frequency of ADHD symptoms. Scores are reported as sums 0 (no symptoms) to 54 (severe).|baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2645635|NCT01709695|Secondary|Digit Span|Neuropsychological assessment - Digit Span. The Digit Span test is either conducted verbally or using a computer program. A sequence of numbers is shown or read out to the participant. The participant is then told to repeat the numbers that were shown or read to them. This process continues until the participant can no longer remember either the full sequence of numbers or the correct order. This sequence is also continued until the participant makes an error. The Digit Span test is scored by the amount of numbers the participant was able to remember in each test. The scorer must add the total number of correct sequences, backwards and forwards. This test is also scored differently for a range of ages.|Baseline||||correct sequences||Standard Deviation|Mean
2645636|NCT01709695|Secondary|Finger Windows|Neuropsychological assessment: Finger Windows - a measure of spatial working memory. The participant shows memory of a demonstrated visual pattern. The examiner models a given sequence of windows and ask the participant to imitate the sequence by placing their finger through the same windows in the correct order. The total number of correct sequences achieved determines the level of performance.|Baseline||||correct sequences||Standard Deviation|Mean
2645637|NCT01709695|Secondary|Percentage Change in Atomoxetine Stimulant Side Effects Rating Scale (ASSERS)|Side effects rating scale. Assesses side effects known to occur in prior research using stimulant and non stimulant medications for treatment of ADHD. Scores range from 0 (not present) to 9 (severe side effects) and have been reported in aggregate as sum of severity responses on highest dose. This number is the sum of ASSERS, meaning it is the number and severity of side effects experienced. The percentage change in score from baseline.|up to 8 weeks||||percentage of mean effects improvement|||Number
2645638|NCT01709695|Secondary|Clinical Global Impressions (CGI-I)|Clinical response was the Clinical Global Impression-Improvement scale (CGI-I). Lower CGI-I scores indicate greater improvement (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6= much worse; 7=very much worse.)|up to 8 weeks||||units on a scale||Standard Deviation|Mean
2645639|NCT01709695|Primary|Go/No-go Task Reaction Time|Measures of go/no-go task performance during functional magnetic resonance imaging. Performance on a go-nogo task inside the scanner.|Baseline and 8 weeks||||ms||Standard Deviation|Mean
2645641|NCT01709578|Secondary|Change From Baseline in Individual ACR Component - HAQ-DI at Week 12 and Week 24|ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS,HAQ-DI & CRP. HAQ-DI consisted of at least 2 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3, where 0 = no disability and 3 = unable to do, high-dependency disability. LS mean and SE at Week 12 & 24 by MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline ACR components as a covariate.|Baseline, Week 12 and Week 24|ITT population. Number analyzed = number of participants with HAQ-DI assessment at both baseline and specified time points.|||units on a scale||Standard Error|Least Squares Mean
2645642|NCT01709578|Secondary|Change From Baseline in Individual ACR Component - CRP Level at Week 12 and Week 24|"ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & CRP. An elevated CRP level was considered a non-specific marker for RA. A reduction level indicates improvement. LS mean and SE at Week 12 & 24 by MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline ACR components as a covariate."|Baseline, Week 12 and Week 24|ITT population. Number analyzed = number of participants with CRP assessment at both baseline and specified time points.|||mg/L||Standard Error|Least Squares Mean
2645643|NCT01709578|Secondary|Change From Baseline in Individual ACR Component - Physician Global VAS, Participant Global VAS and Pain VAS at Week 12 and Week 24|"ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS, HAQ-DI & CRP. Physician global VAS & participant global VAS was done by 100 mm non-anchored VAS, from no arthritis (0) activity to maximal arthritis (100) activity. Pain VAS by 100 mm VAS ranging from 0 no pain to 100 worst pain. LS mean and SE at Week 12 & 24 by MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline ACR components as a covariate."|Baseline, Week 12 and Week 24|ITT population. Number analyzed = number of participants with individual ACR components assessment at both baseline and specified time points.|||mm||Standard Error|Least Squares Mean
2645644|NCT01709578|Secondary|Change From Baseline in Individual ACR Components - TJC and SJC at Week 12 and Week 24|ACR components were: TJC, SJC, physician global VAS, participant global VAS, pain VAS,HAQ-DI & CRP. 68 joints were assessed for tenderness (TJC scoring 0-68) and 66 joints for swelling (SJC scoring 0-66). The 66 SJC evaluated the following joints: temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal, interphalangeal of thumb, distal interphalangeal, proximal interphalangeal, knee, ankle mortise, ankle tarsus, metatarsophalangeal, interphalangeal of great toe, and proximal/distal interphalangeal of the toes. The TJC examined hip joints, in addition to the joints assessed for SJC. Increase in number of tender joints/swollen joints indicated severity. LS mean and SE at Week 12 & 24 by MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline ACR components as a covariate.|Baseline, Week 12 and Week 24|ITT population. Number analyzed = number of participants with TJC and SJC assessments at both baseline and specified time points.|||joints||Standard Error|Least Squares Mean
2645645|NCT01709578|Secondary|Change From Baseline in RAID Scores at Week 12|RAID score is a composite measure of the impact of RA on participants that takes into account 7 domains: pain, functional disability, fatigue, physical and emotional well being, quality of sleep, and coping. The RAID is calculated based on 7 NRS questions. Range of the final RAID value is 0-10 where 0= not affected, very good and 10 = most affected weighted and calculated with a total score range of 0 (not affected, very good) to 10 (most affected). A higher RAID value indicates worse status and lower indicates not affected. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline RAID scores as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = number of participants with RAID score assessment at both baseline and Week 12.|||units on a scale||Standard Error|Mean
2645646|NCT01709578|Secondary|Change From Baseline in EQ-5D-3L VAS Scores at Week 12|The EQ-5D-3L is a standardized, generic measure of health outcome. EQ-5D was designed for self-completion by participants. The EQ-5D was specifically included to address concerns regarding the health economic impact of RA. The EQ-5D-3L comprises 5 questions on mobility, self-care, pain, usual activities, and psychological status with 3 possible answers for each item (1=no problem, 2=moderate problems, 3=severe problems) and a vertical VAS that allows the participants to indicate their health state today that can range from 0 (worst imaginable) to 100 (best imaginable). LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline EQ-5D-3L scores as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = number of participants with EQ-5D-3L score assessment at both baseline and Week 12.|||units on a scale||Standard Error|Least Squares Mean
2645647|NCT01709578|Secondary|Change From Baseline in the FACIT-fatigue at Week 12|The FACIT-Fatigue is a 13-item questionnaire assessing fatigue where participants scored each item on a 5-point scale (0-4): 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. A total score ranging from 0 to 52. A higher score corresponded to a lower level of fatigue. A positive change from baseline score indicates an improvement. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline FACIT-fatigue as a covariate.|Baseline, Week 12|ITT population. Number of Participants analyzed = number of participants with FACIT-fatigue score assessment at both baseline and Week 12.|||units on a scale||Standard Error|Least Squares Mean
2645676|NCT01709578|Secondary|Percentage of Participants Achieving Clinical Remission Score (DAS28-CRP) <2.6 at Week 24|DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH by the participant assessed from the ACR rheumatoid arthritis core set questionnaire (participant global assessment) in 100 mm VAS; marker of inflammation assessed by hs-CRP in mg/L. The DAS28 provides a number indicating the current activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission.|Week 24|ITT population.|||Percentage of participants|||Number
2645648|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: RA Interference With Household Work Productivity|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). The RA interference in the last month with household work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.|||units on a scale||Standard Error|Least Squares Mean
2645649|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: Days With Outside Help Hired Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with outside help hired in the last month by the participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.|||Days||Standard Error|Least Squares Mean
2645650|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: Days With Family/Social/Leisure Activities Missed Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days missed of family/social/leisure activities in the last month by the participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.|||Days||Standard Error|Least Squares Mean
2645651|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: Days With Household Work Productivity Reduced by ≥ 50% Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with reduced household work productivity by ≥ 50% in the last month by the participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.|||Days||Standard Error|Least Squares Mean
2645652|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: House Work Days Missed Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with no household work in the last month by the participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.|||Days||Standard Error|Least Squares Mean
2645653|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: RA Interference With Work Productivity|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Interference in the last month with work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.|||units on a scale||Standard Error|Least Squares Mean
2645654|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: Days With Work Productivity Reduced by ≥ 50% Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days with reduced productivity by ≥ 50% in the last month by the participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 12.|||Days||Standard Error|Least Squares Mean
2645677|NCT01709578|Secondary|Percentage of Participants Achieving ACR70 Criteria at Week 24|ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR70 is defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments of the ACR.|Week 24|ITT population.|||Percentage of participants|||Number
2645655|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 12: Work Days Missed Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days missed in the last month by the participant was reported. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed=participants with WPS-RA individual items assessment at both baseline and Week 12.|||Days||Standard Error|Least Squares Mean
2645656|NCT01709578|Secondary|Change From Baseline in SF-36 at Week 12|SF-36 is a generic 36-item questionnaire measuring HRQL covering 2 summary measures: PCS and MCS. The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores indicate better health and well-being. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline SF-36 as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed=participants with SF-36 assessment at both baseline and Week 12.|||units on a scale||Standard Error|Least Squares Mean
2645657|NCT01709578|Secondary|Percentage of Participants Achieving Clinical Remission Score (DAS28--CRP <2.6) at Week 12|DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH by the participant assessed from the ACR RA core set questionnaire (participant global assessment) in 100 mm VAS; marker of inflammation assessed by hs-CRP in mg/L. The DAS28 provides a number indicating the current activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission.|Week 12|ITT population.|||Percentage of participants|||Number
2645658|NCT01709578|Secondary|Change From Baseline in DAS28-CRP at Week 12|DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); GH by the participant assessed from the ACR rheumatoid arthritis core set questionnaire (participant global assessment) in 100 mm VAS; marker of inflammation assessed by hs-CRP in mg/L. The DAS28 provides a number indicating the current activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission. LS mean and SE at Week 12 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline DAS score as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = number of participants with DAS28-CRP­ Score assessment at both baseline and Week 12.|||units on a scale||Standard Error|Least Squares Mean
2645659|NCT01709578|Secondary|Percentage of Participants Achieving ACR20, ACR50 and ACR70 Criteria at Week 12|ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR. ACR50 is defined as achieving at least 50% improvement in both TJC and SJC, and at least 50% improvement in at least 3 of the 5 other assessments of the ACR. ACR70 is defined as achieving at least 70% improvement in both TJC and SJC, and at least 70% improvement in at least 3 of the 5 other assessments of the ACR.|Week 12|ITT population.|||Percentage of participants|||Number
2645660|NCT01709578|Secondary|Change From Baseline in European Quality of Life-5 Dimension 3 Level (EQ-5D-3L) VAS Scores at Week 24|The EQ-5D-3L is a standardized, generic measure of health outcome. It was designed for self-completion by participants. It was specifically included to address concerns regarding the health economic impact of RA. The EQ-5D-3L comprises 5 questions on mobility, self-care, pain, usual activities, and psychological status with 3 possible answers for each item (1=no problem, 2=moderate problems, 3=severe problems) and a vertical VAS that allows the participants to indicate their health state today that can range from 0 (worst imaginable) to 100 (best imaginable). LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline EQ-5D-3L Scores as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = number of participants with EQ-5D-3L score assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2645661|NCT01709578|Secondary|Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Scores at Week 24|RAID is a composite measure of the impact of RA on participants that takes into account 7 domains: pain, functional disability, fatigue, physical and emotional well being, quality of sleep, and coping. The RAID is calculated based on 7 numerical rating scales (NRS) questions. Range of the final RAID value is 0-10 where 0= not affected, very good and 10 = most affected weighted and calculated with a total score range of 0 (not affected, very good) to 10 (most affected). A higher RAID value indicate worse status and lower indicate not affected. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline RAID as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = number of participants with RAID score assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2645693|NCT01709513|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.|||percentage of participants|||Number
2645662|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: RA Interference With Household Work Productivity|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). The RA interference in the last month with household work productivity was measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2645663|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Outside Help Hired Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with outside help hired in the last month by the participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.|||Days||Standard Error|Least Squares Mean
2645664|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Family/Social/Leisure Activities Missed Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days missed of family/social/leisure activities in the last month by the participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.|||Days||Standard Error|Least Squares Mean
2645665|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Household Work Productivity Reduced by ≥ 50% Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with reduced household work productivity by ≥ 50% in the last month by the participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.|||Days||Standard Error|Least Squares Mean
2645666|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: House Work Days Missed Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of days with no household work in the last month by the participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.|||Days||Standard Error|Least Squares Mean
2645667|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: RA Interference With Work Productivity|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2645668|NCT01709578|Secondary|Change From Baseline in WPS-RA at Week 24: Days With Work Productivity Reduced by ≥ 50% Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days with reduced productivity by ≥ 50% in the last month by the participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with WPS-RA individual items assessment at both baseline and Week 24.|||Days||Standard Error|Least Squares Mean
2645678|NCT01709578|Secondary|Percentage of Participants Achieving ACR50 Criteria at Week 24|ACR responses are assessed with a composite rating scale that includes 7 variables: TJC; SJC; levels of an acute phase reactant (CRP level); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by HAQ--DI. ACR50 is defined as achieving at least 50% improvement in both TJC and SJC, and at least 50% improvement in at least 3 of the 5 other assessments of the ACR.|Week 24|ITT population.|||Percentage of participants|||Number
2645669|NCT01709578|Secondary|Change From Baseline in Work Productivity Survey - Rheumatoid Arthritis (WPS-RA) at Week 24: Work Days Missed Due to RA|The WPS-RA is a validated questionnaire that evaluates productivity limitations within work and within home associated with RA over the previous month. The questionnaire was interviewer-administered and was based on participant self-report. It contains 9 questions addressing employment status (1 item), productivity at work (3 items), and within and outside the home (5 items). Number of work days missed in the last month by the participant was reported. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline WPS-RA as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed=participants with WPS-RA individual items assessment at both baseline and Week 24.|||Days||Standard Error|Least Squares Mean
2645670|NCT01709578|Secondary|Change From Baseline in Morning Stiffness VAS at Week 24|RA is associated with stiffness of joints, especially in the morning after prolonged stationery state. The degree of stiffness can be an indicator of disease severity. The severity of morning stiffness was assessed on a VAS scale from 0 mm (no problem) to 100 mm (major problem). LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline Morning Stiffness as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = number of participants with morning stiffness VAS assessment at both baseline and Week 24.|||mm||Standard Error|Least Squares Mean
2645671|NCT01709578|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-fatigue) Score at Week 24|The FACIT-Fatigue is a 13-item questionnaire assessing fatigue where participants scored each item on a 5-point scale (0-4): 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much. A total score ranging from 0 to 52. A higher score corresponded to a lower level of fatigue. A positive change from baseline score indicates an improvement. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline FACIT-fatigue as a covariate.|Baseline, Week 24|ITT population. Number of Participants analyzed = number of participants with FACIT-fatigue score assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2645672|NCT01709578|Secondary|Change From Baseline in SF-36 MCS at Week 24|SF-36 is a generic 36-item questionnaire measuring HRQL covering 2 summary measures: PCS and MCS. The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores indicate better health and well-being. LS mean and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline SF-36 MCS as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed=participants with SF-36 MCS assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2645673|NCT01709578|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Physical Component Summary Scores (PCS) at Week 24|SF-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: PCS and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS had 4 subscales: physical function, role limitations due to physical problems, pain, and general health perception. The MCS had 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have between 2-6 choices per item using Likert-type responses (e.g. none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores indicate better health and well-being. LS mean and SE at Week 24 by MMRM with treatment,region,number of previous anti TNFs,visit,and treatment-by-visit interaction as fixed effects and baseline SF-36 (PCS) as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = participants with SF-36 PCS assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2645674|NCT01709578|Secondary|Change From Baseline in HAQ-DI at Week 24|Physical function was assessed by HAQ-DI. It consisted of at least 2 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3, where 0 = no disability and 3 = unable to do, high-dependency disability. LS means and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline HAQ-DI as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = number of participants with HAQ-DI assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2645675|NCT01709578|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24|CDAI is a composite index constructed to measure clinical remission in RA that does not include a laboratory test, and is a numerical summation of 4 components: TJC (28 joints), SJC (28 joints), Participant's Global Assessment of Disease Activity VAS (in cm), and Physician's Global Assessment of Disease VAS (in cm). Total scores ranges from 0 to 76 with a negative change in CDAI score indicating an improvement in disease activity and a positive change in score indicating a worsening of disease activity. LS means and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline CDAI as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed=number of participants with CDAI assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2645692|NCT01709513|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first (on-treatment analysis).|Up to Week 24|mITT population.|||percentage of participants|||Number
2645679|NCT01709578|Secondary|Change From Baseline in Disease Activity Score for 28 Joints -C-Reactive Protein (DAS28--CRP) Score at Week 24|DAS28 is a composite score that includes 4 variables: TJC (based on 28 joints); SJC (based on 28 joints); General health (GH) assessment by the participant assessed from the ACR rheumatoid arthritis (RA) core set questionnaire (participant global assessment) in 100 mm visual analog scale (VAS). Marker of inflammation assessed by the high sensitivity C-reactive protein (hs-CRP) in mg/L. The DAS28 score provides a number indicating the current disease activity of the RA. DAS28 total score ranges from 2-10. A DAS28 score above 5.1 means high disease activity, whereas a DAS28 score below 3.2 indicates low disease activity and a DAS28 score below 2.6 means disease remission. LS means and SE at Week 24 were obtained from a MMRM with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline DAS28-CRP score as a covariate.|Baseline, Week 24|ITT population. Number of participants analyzed = number of participants with DAS28-­CRP Score assessment at both baseline and Week 24.|||units on a scale||Standard Error|Least Squares Mean
2645680|NCT01709578|Primary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12|Physical function was assessed by HAQ-DI. It consisted of at least 2 questions per category, participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week rated on a 4-point scale where 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of category scores and divided by the number of categories answered, ranging from 0 to 3, where 0 = no disability and 3 = unable to do, high-dependency disability. Least-squares (LS) means and standard errors (SE) at Week 12 were obtained from a mixed-effect model with repeated measures (MMRM) with treatment, region, number of previous anti-TNFs, visit, and treatment-by-visit interaction as fixed effects and baseline HAQ-DI as a covariate.|Baseline, Week 12|ITT population. Number of participants analyzed = number of participants with HAQ-DI assessment at both baseline and Week 12.|||units on a scale||Standard Error|Least Squares Mean
2645681|NCT01709578|Primary|Percentage of Participants Who Achieved at Least 20% Improvement in the American College of Rheumatology (ACR20) Criteria at Week 24|ACR responses are assessed with a composite rating scale of the American College of Rheumatology that includes 7 variables: tender joint count (TJC); swollen joint count (SJC); levels of an acute phase reactant (C-reactive Protein levels [CRP]); participant's assessment of pain; participant's global assessment of disease activity; physician's global assessment of disease activity; participant's assessment of physical function by (health assessment questionnaire disability index [HAQ-DI]). ACR20 is defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments of the ACR.|Week 24|Intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
2645682|NCT01709513|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 24 Versus Atorvastatin - Raw Data Description - Intent-To-Treat (ITT) Analysis||From Baseline up to Week 24|ITT population|||percent change||Standard Deviation|Mean
2645683|NCT01709513|Other Pre-specified|Percentage of Participants Who Experienced Skeletal Muscle-related Adverse Event (AE)|Skeletal muscle-related adverse events were a predefined category including myalgia, muscle spasms, muscular weakness, musculoskeletal stiffness and muscle fatigue. Events that developed during treatment emergent adverse events period (the time from the first double-blindstudy treatment [injection or capsules, whichever came first] up to the day of the last double-blind injection + 70 days ) are reported.|From Baseline up to Week 24|Safety population|||participants|||Number
2645684|NCT01709513|Secondary|Percent Change From Baseline in Apo A--1 at Week 12 -- ITT Analysis|Least squares (LS) means and standard errors (SE) taken from MMRM (mixed effect model with repeated measures) analysis.|From Baseline to Week 12|Apo A-1 ITT population.|||percent change||Standard Error|Least Squares Mean
2645685|NCT01709513|Secondary|Percent Change in Fasting Triglycerides From Baseline to Week 12 -- ITT Analysis|Combined Estimate for Adjusted Mean (Standard Error) at Week 24 from multiple imputation followed by robust regression including all available post-baseline data from Week 4 to Week 24 regardless of status on or off-treatment.|From Baseline to Week 12|Fasting Triglycerides ITT population.|||percent change||Standard Error|Mean
2645686|NCT01709513|Secondary|Percent Change in HDL-C From Baseline to Week 12 -- ITT Analysis|Least-squares (LS) means and standard errors (SE) taken from MMRM (mixed-effect model with repeated measures) analysis|From Baseline to Week 12|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2645687|NCT01709513|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12 -- ITT Analysis|Combined Estimate for Adjusted Mean (Standard Error) at Week 24 from multiple imputation followed by robust regression including all available post-baseline data from Week 4 to Week 24 regardless of status on or off-treatment.|From Baseline to Week 12|Lipoprotein(a) ITT population.|||percent change||Standard Error|Mean
2645688|NCT01709513|Secondary|Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2645689|NCT01709513|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Combined Estimate for Adjusted Mean (Standard Error) at Week 24 from multiple imputation followed by robust regression including all available post-baseline data from Week 4 to Week 24 regardless of status on or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population|||percent change||Standard Error|Mean
2645690|NCT01709513|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2645691|NCT01709513|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Combined Estimate for Adjusted Mean (Standard Error) at Week 24 from multiple imputation followed by robust regression including all available post-baseline data from Week 4 to Week 24 regardless of status on or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population.|||percent change||Standard Error|Mean
2645694|NCT01709513|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first (on-treatment analysis).|Up to Week 24|mITT population.|||percentage of participants|||Number
2645695|NCT01709513|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or Moderate or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 24|ITT population.|||percentage of participants|||Number
2645696|NCT01709513|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 12|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
2645697|NCT01709513|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 12|Non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2645698|NCT01709513|Secondary|Percent Change From Baseline in Apo B at Week 12 -- ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 12|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
2645699|NCT01709513|Secondary|Percent Change From Baseline in Total Cholesterol (Total--C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2645700|NCT01709513|Secondary|Percent Change From Baseline in Non--HDL-C at Week 24 -- On--Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2645701|NCT01709513|Secondary|Percent Change From Baseline in Non--High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 -- ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2645702|NCT01709513|Secondary|Percent Change From Baseline in Apo B at Week 24 -- On--Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 24|Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment.|||percent change||Standard Error|Least Squares Mean
2645703|NCT01709513|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 -- ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post--baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2645704|NCT01709513|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On--Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).|From Baseline to Week 12|mITT population.|||percent change||Standard Error|Least Squares Mean
2645705|NCT01709513|Secondary|Percent Change From Baseline in Calculated LDL--C at Week 12 -- ITT Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 12|ITT population.|||percent change||Standard Error|Least Squares Mean
2645706|NCT01709513|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On--Treatment Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).|From Baseline to Week 24|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2645707|NCT01709513|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent--To-Treat (ITT) Analysis|Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on­ or off-treatment.|||percent change||Standard Error|Least Squares Mean
2645709|NCT01709500|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Fasting triglycerides ITT population.|||percent change||Standard Error|Mean
2645710|NCT01709500|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2645711|NCT01709500|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Lipoprotein (a) ITT population.|||percent change||Standard Deviation|Mean
2645712|NCT01709500|Secondary|Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2645713|NCT01709500|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population.|||percent change||Standard Error|Mean
2645714|NCT01709500|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2645715|NCT01709500|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population.|||percent change||Standard Error|Mean
2645716|NCT01709500|Secondary|Percentage of Participants Reaching Calculated LDL--C <70 mg/dL (1.81 mmol/L) at Week 52 - On-Treatment Analysis|Adjusted percentages at Week 52 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis).|Up to Week 52|mITT population.|||percentage of participants|||Number
2645717|NCT01709500|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 52|ITT population.|||percentage of participants|||Number
2645718|NCT01709500|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL--C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL--C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis).|Up to week 52|mITT population.|||percentage of participants|||Number
2645719|NCT01709500|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).|Up to Week 52|ITT population.|||percentage of participants|||Number
2645720|NCT01709500|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off treatment (ITT analysis).|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
2645721|NCT01709500|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post baseline data from Week 4 to Week 52 regardless of status on- or off treatment.|From Baseline to Week 52|Total-­C ITT population.|||percent change||Standard Error|Least Squares Mean
2645722|NCT01709500|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2645723|NCT01709500|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
2645724|NCT01709500|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2645725|NCT01709500|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population|||percent change||Standard Error|Least Squares Mean
2645726|NCT01709500|Secondary|Percent Change From Baseline in Non-High -Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2645727|NCT01709500|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population|||percent change||Standard Error|Least Squares Mean
2645728|NCT01709500|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2645729|NCT01709500|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On- Treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|mITT population.|||percent change||Standard Error|Least Squares Mean
2645730|NCT01709500|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment (ITT analysis).|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
2645731|NCT01709500|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2645732|NCT01709500|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent--to--Treat (ITT) Analysis|Calculated LDL-C values were obtained using the Friedewald formula. Adjusted Least- squares (LS) means and standard errors at Week 24 were obtained from a mixed -effect model with repeated measures (MMRM) to account for missing data. All available post -baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model.|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2645733|NCT01709474|Primary|Percentage of Subjects by Treatment Arm Experiencing Any Adverse Event (AE) ≥ Grade 3|Adverse event grading based on National Cancer Institute— Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0|Baseline to 18 Weeks|Intent-to-treat|||Percentage of Participants|||Number
2645734|NCT01709474|Primary|Change in Average IFN Module Expression Level|No mechanistic analyses were performed due to recruitment feasibility issues.|Baseline to Week 18|Data were not collected and therefore no analyses could be performed.||||||
2645735|NCT01709422|Primary|Procedure Related Time|(1) induction time ( the time from sedation to scope intubation ), (2) procedure time ( the time from scope intubation to scope withdrawal ) and (3) recovery time ( the time from scope withdrawal to full recovery ).The induction time, procedural time and recovery time were recorded by the nurse in the endoscopy unit.|participants will be followed for the duration of procedure, an expected average of 2.0 hours ]|Intention to treat population include participants who received sedative agents and underwent endoscopic retrograde cholangiopancreatography(ERCP).|||minutes||Standard Deviation|Mean
2645736|NCT01709422|Secondary|Cardiovascular Adverse Events.|(1) desaturation(oxygen saturation < 90 % at least 10 second ) (2) hypotension ( systolic blood pressure < 90 mmHg or dropped more than 25 % of baseline ) (3)bradycardia (heart rate < 50 beats/min) and (4) apnea ( cessation of respiratory activity for over 10 seconds ). When patients developed oxygen saturation < 90 %, then nasal oxygen was administered, If patients not able to recover from oxygen therapy and tactile stimulations thus the procedure was terminated. The procedure was terminated if patients developed serious adverse event as heart rate below 5 beats/min and or apnea.|participants will be followed for the duration of procedure, an expected average of 2.0 hours|Intention to treat population include participants who received sedative agents and underwent ERCP.|||Participants|||Number
2645737|NCT01709409|Secondary|Curosurf-01|7. Mortality prior to discharge|36 weeks GA|||||||
2645738|NCT01709409|Secondary|Curosurf-01|6. Bronchopulmonary dysplasia, defined as oxygen or respiratory support requirement at 36 weeks corrected GA|36 Weeks GA|||||||
2645739|NCT01709409|Secondary|Curosurf-01|5. Adverse events during or after administration of surfactant|36 weeks GA|||||||
2645740|NCT01709409|Secondary|Curosurf-01|4. Number of doses of surfactant received|36 weeks GA|||||||
2645741|NCT01709409|Secondary|Curosurf-01|3. Total duration of respiratory support (ventilator and nCPAP) and total number of days of oxygen requirement|36 weeks GA|||||||
2645742|NCT01709409|Secondary|Curosurf-01|2. Duration of first intubation (in hours/days)|36 weeks GA|||||||
2645743|NCT01709409|Secondary|To Compare the Duration of Respiratory Support, Extubation Failure Rates, Need for Additional Surfactant Doses, Adverse Events (During and Following Administration), Survival and Pulmonary Morbidities During Hospital Admission Between the Two Groups.|1. Extubation failure|36 weeks GA|||||||
2645744|NCT01709409|Primary|The Primary Objective of the Study is to Compare Between the Two Groups, the Number of Subjects Alive and Extubated at 48 Hours Post Surfactant Administration. Extubation|"rate on ventilator ≤40 per minute and~mean airway pressure ≤ 10 cm H20 and~fi02 ≤ 30%"|48 hours||||Participants|||Count of Participants
2645780|NCT01709227|Secondary|Duration of Cardiac ICU Stay|Total days of initial postoperative stay in cardiac ICU|Average 2 weeks||||days||Inter-Quartile Range|Median
2645745|NCT01709383|Secondary|Motricity Index|An assessment of upper extremity motor impairment, including: pinch grip, elbow flexion, and shoulder abduction. For pinch grip, which consisted of holding a small plastic cube between the thumb and index finger, scoring was as follows: 0=No movement, 11=Beginnings of prehension, 19=Grips cube but unable to hold against gravity, 22=Grips cube, held against gravity but not against weak pull, 26=Grips cube against pull but weaker than left side, 33=Normal pinch grip. For elbow flexion and shoulder abduction, scoring was as follows: 0=No movement, 9=Palpable contraction in muscle but no movement, 14=Movement seen but not full range/not against gravity, 19=Full range against gravity, not against resistance, 25=Movement against resistance but weaker than left side, 33=Normal power. Both the right and the left side were tested.|Change from baseline to 1 day after treatment|People with aphasia due to left hemisphere stroke|||scores on a scale||Standard Deviation|Mean
2645746|NCT01709383|Secondary|Reading Assessments|A set of reading tasks designed to assess oral reading of real words and non-words at the single word level. The list of real words consisted of 142 words. A score of 0 indicates no words were read correctly and a score of 142 indicates all words were read correctly. The non-word test included 30 non-words. A score of 0 indicates no non-words were read correctly and a score of 30 indicates that all non-words were read correctly.|Change from baseline to 1 day after treatment|People with aphasia due to left hemisphere stroke|||scores on a scale||Standard Deviation|Mean
2645747|NCT01709383|Secondary|Cognitive-Linguistic Quick Test (CLQT)|The following subtests from the CLQT will be administered: Symbol Cancellation, Story Retelling, Generative Naming, Symbol Trails, Design Memory, Mazes,and Design Generation. These scores will be used to calculate composite scores for the cognitive domains of Attention, Executive Function (EF), and Visuospatial skills (VS). Some tests are weighted more than others in each composite score, by multiplying the score as follows and then adding the scores together: Attention = Symbol Cancellation (x9), Story Retelling (x2), Symbol Trails (x3), Mazes (x4), and Design Generation (x1); EF = sum of Symbol Trails, Generative Naming, Mazes, and Design Generation; VS = Symbol Cancellation (x2), Symbol Trails (x2), Design Memory (x4), Mazes (x3), Design Generation (x1). For all composite scores, a low number indicates greater deficit. For Attention, the highest score is 215 and lowest is 0. For EF, the highest score is 40 and lowest is 0. For VS, the highest score is 105 and lowest is 0|Change from baseline to 1 day after treatment|People with aphasia due to left hemisphere stroke|||scores on a scale||Standard Deviation|Mean
2645748|NCT01709383|Secondary|Subjective Assessments Including: Communicative Effectiveness Index (CETI), Stroke and Aphasia Quality of Life Scale (SAQOL), and Stroke Aphasic Depression Questionnaire (SADQ)|"Questionnaires were given at baseline, 3 weeks and 3 months after treatment. The SADQ consists of 21 questions graded on a 0-3 scale with 3 indicating the highest depression symptoms and 0 indicating none. Therefore, means reported below are an average score between 0 and 3. The SAQOL includes 17 questions about functional physical limitations and 7 questions about functional communication limitations in daily life. Questions are rated on a 1-5 scale with a score of 1 indicating greater disability and 5 indicating none. Therefore, means reported below are an average score between 1 and 5. The CETI measures change in functional communication by asking caregivers to make a mark on a straight line with as able as before the stroke written on the right side of the line and not at all as able on the left. The 16 responses are then converted by measuring the location of the mark on the line. A score of 10 indicates as able as before the stroke and 0 indicates not at all as able."|3 weeks post-treatment|People with aphasia due to left hemisphere stroke|||scores on a scale||Standard Deviation|Mean
2645749|NCT01709383|Secondary|Philadelphia Naming Test (PNT)|A test of picture naming using more common items than other picture naming tests, which reduces relationships between performance and premorbid education and socioeconomic status. There are 60 items on the test. A score of 0 means no pictures were named correctly. A score of 60 means all pictures were named correctly.|1 day after treatment|People with aphasia due to left hemisphere stroke|||scores on a scale||Standard Deviation|Mean
2645750|NCT01709383|Secondary|Western Aphasia Battery - Revised: Spontaneous Speech, Repetition, Auditory Verbal Comprehension and Overall Aphasia Quotient|The above subtests will reflect the following: a composite measure of information content in conversational speech and picture description (scored from 0 (no speech produced or only meaningless utterances) to 10 (no signs of aphasia)); a measure of word and sentence repetition (scored from 0 (unable to repeat any part of a single word) to 100 (perfect repetition of all words and up to a 10 word sentence)); a composite measure of yes/no questions, auditory word recognition, and following sequential commands (composite subscore is from 1 to 10, with 10 being the best outcome); and an overall aphasia severity score (composite score, or Aphasia Quotient, comprised of all the above measures plus the naming and word finding score used as the primary outcome measure. Quotient scores range from 0 to 100, with 100 indicating no aphasia is present).|Change from baseline to 1 day after treatment|People with aphasia due to left hemisphere stroke|||scores on a scale||Standard Deviation|Mean
2645751|NCT01709383|Primary|Western Aphasia Battery - Revised: Naming and Word Finding Score|This is a composite measure of verbal expression skills including tests of naming, verbal fluency, sentence completion, and responsive naming (one-word answers to basic questions). It is a subtest within the Western Aphasia Battery. The minimum score is 0 and maximum is 10, with 10 being the best outcome, and subscores are summed to determine the total score.|Change from baseline to one day after treatment|People with aphasia due to left hemisphere stroke|||scores on a scale||Standard Deviation|Mean
2645752|NCT01709331|Secondary|Percentage of Participants With Induced Spermatogenesis Resulting in a Sperm Count ≥1x10^6/mL at or Before Week 52|Semen samples were produced by masturbation after at least 48 hours of sexual abstinence and collected for evaluation in the pretreatment phase at Week -1, and during the combined treatment phase at Weeks 16, 28, 40, and 52.|Up to Week 52|FAS population, which consisted of all participants who received any dose of corifollitropin alfa and who had a baseline and at least one post-baseline measurement of testicular volume.|||Percentage of participants||95% Confidence Interval|Number
2645753|NCT01709331|Primary|Percentage of Participants With Anti-Corifollitropin Alfa Antibodies|Blood samples were collected for assessment of anti-corifollitropin alfa antibodies in the pretreatment phase at Week -16 and Week -1; during the combined treatment phase at Weeks 4, 16, 28, 50, 52; and at the post-treatment follow-up visit, which could occur from Week 53 up to Week 57.|Up to Week 57|All-Subjects-as-Treated (ASaT) population, which consisted of all participants who received any dose of corifollitropin alfa.|||Percentage of participants|||Number
2645754|NCT01709331|Primary|Change From Baseline in Log-Transformed Testicular Volume at Week 52|Participants underwent testicular ultrasound in the pretreatment phase at Weeks -16, -8, -1; and during the combined treatment phase at Baseline (predose, Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52. The testicular volume was measured as the sum of volumes of left and right testes. The mean change from Day 1 in log-transformed testicular volume was analyzed using a mixed model with a fixed effect for time point and a random effect for the participant. For each time point, the mean change from Day 1 to that time point and the associated 95% confidence interval (CI) was calculated. The geometric mean fold change in testicular volume and its 95% CI was obtained by exponentiation.|Baseline and Week 52|Full Analysis Set (FAS) population, which consisted of all participants who received any dose of corifollitropin alfa and who had a baseline and at least one post-baseline measurement of testicular volume.|||Fold change||95% Confidence Interval|Geometric Mean
2645755|NCT01709318|Secondary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Up to ~92 days|The analysis population included all randomized participants in whom a vaginal ring was inserted.|||Percentage of Participants|||Number
2645756|NCT01709318|Secondary|Percentage of Participants With Any Drug-Related Serious Adverse Event|A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment. A drug-related SAE was defined as any SAE for which there is reasonable possibility of drug relationship as assessed by the Investigator.|Up to ~92 days|The analysis population included all randomized participants in whom a vaginal ring was inserted.|||Percentage of Participants|||Number
2645757|NCT01709318|Secondary|Percentage of Participants Who Experienced At Least One Drug-Related Adverse Event|An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.|Up to ~92 days|The analysis population included all randomized participants in whom a vaginal ring was inserted.|||Percentage of Participants|||Number
2645758|NCT01709318|Secondary|Percentage of Participants Who Experienced At Least One Serious Adverse Event|A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment.|Up to ~92 days|The analysis population included all randomized participants in whom a vaginal ring was inserted.|||Percentage of Participants|||Number
2645759|NCT01709318|Secondary|Percentage of Participants Who Experienced At Least One Adverse Event|An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Up to ~92 days|The analysis population included all randomized participants in whom a vaginal ring was inserted.|||Percentage of Participants|||Number
2645760|NCT01709318|Other Pre-specified|Number of Participants With Venous or Arterial Thrombotic/Thromboembolic Events|Venous or arterial thrombotic/thrombo-embolic events, (VTEs or ATEs) (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident) were assessed.|From Cycle 1 Day 1 up to 8 days after Day 28 of Cycle 3 (Up to ~92 days)|The analysis population included all randomized participants in whom a vaginal ring was inserted.|||Participants|||Count of Participants
2645761|NCT01709318|Secondary|Intensity of Breakthrough Bleeding and/or Spotting During Cycle 3|Intensity of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3 was defined as the ratio of the number of breakthrough bleeding days divided by the number of breakthrough bleeding and/or spotting days. Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day.|Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~ 28 days)|The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, and with at least one breakthrough bleeding and/or spotting day, excluding protocol violators in terms of ring use, daily diary entry or prohibited medications.|||Ratio||Standard Deviation|Mean
2645762|NCT01709318|Secondary|Intensity of Withdrawal Bleeding During Cycle 2|Intensity of withdrawal bleeding during Cycle 2 was defined as the ratio of the number of withdrawal bleeding days divided by the number of withdrawal bleeding and/or spotting days. Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed.|Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)|The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, and with at least one withdrawal bleeding or spotting day, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.|||Ratio||Standard Deviation|Mean
2645763|NCT01709318|Secondary|Percentage of Participants With Absence of Withdrawal Bleeding and/or Spotting During Cycle 2|Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed.|Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)|The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.|||Percentage of Participants|||Number
2645764|NCT01709318|Primary|Percentage of Participants With Breakthrough Bleeding and/or Spotting During Cycle 3|Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day.|Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~28 days)|The analysis population included all participants in whom vaginal rings were inserted and had an evaluable cycle with non-missing bleeding data in the respective cycle, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.|||Percentage of Participants|||Number
2645765|NCT01709318|Primary|Percentage of Participants With Progesterone Concentrations >16 Nmol/L, by Cycle|Maximum progesterone (Max P) was defined as the maximum progesterone value. Ovulation was defined as 2 or more consecutive progesterone concentrations >16 nmol/L within 5 days during the 3 treatment cycles, supported by ultrasound evidence of ovulation. The Max P values greater than 16 nmol/L are presented by vaginal ring group and cycle.|Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)|The analysis population included all participants in whom vaginal rings were inserted and received hormonal assessment for progesterone concentration, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.|||Percentage of Participants|||Number
2645766|NCT01709318|Primary|Percentage of Participants With Ovulation Incidence, by Cycle|Ovulation was defined as having 2 or more consecutive progesterone concentrations >16 nmol/L within 5 days, confirmed by ultrasound evidence of ovulation (follicular rupture or preceding presence of a follicle-like structure >15 mm in size).|Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)|The analysis population included all participants in whom vaginal rings were inserted and received ultrasound and hormonal assessments, excluding participants who were protocol violators in terms of ring use, daily diary entry or prohibited medications.|||Percentage of Participants|||Number
2645767|NCT01709305|Secondary|Percentage of Participants With a GI AE of Abdominal Pain (Phase 2)|"The percentage of participants with a GI AE of abdominal pain was reported."|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.|||Percentage of Participants|||Number
2645768|NCT01709305|Secondary|Percentage of Participants With a GI AE of Diarrhea (Phase 2)|"The percentage of participants with a GI AE of diarrhea was reported."|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.|||Percentage of Participants|||Number
2645769|NCT01709305|Secondary|Percentage of Participants With a GI AE of Vomiting (Phase 2)|"The percentage of participants with a GI AE of vomiting was reported."|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.|||Percentage of Participants|||Number
2645770|NCT01709305|Secondary|Percentage of Participants With a Gastrointestinal (GI) AE of Nausea (Phase 2)|"The percentage of participants with a GI AE of nausea was reported."|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.|||Percentage of Participants|||Number
2645771|NCT01709305|Secondary|Percentage of Participants With Hypoglycemia Events (Phase 2)|Hypoglycemia events represent epidsodes symptomatic of hypoglycemia (e.g., weakness, dizziness, shakiness, increased sweating, palpitations, or confusion) and/or finger stick glucose values of ≤70 mg/dL (3.9 mmol/L). The percentage of participants with hypoglycemia events was reported.|From Week 20 through Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.|||Percentage of Participants|||Number
2645772|NCT01709305|Secondary|Change From Phase 2 Baseline to Week 44 in Participant Body Weight (Phase 2)|Change from baseline in body weight in Phase 2 was reported. Change from baseline reflects the Week 44 body weight minus baseline body weight. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used.|Phase 2 Baseline (Week 20), Week 44|All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.|||kg||Standard Deviation|Mean
2645773|NCT01709305|Primary|Change From Phase 2 Baseline to Week 44 in Hemoglobin A1c (HbA1c) Levels (Phase 2)|HbA1c is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change from baseline reflects the Week 44 A1C minus baseline A1C. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used. Change from baseline was based on the constrained longitudinal data analysis (cLDA) model including all available measurements from baseline through the last visit. The terms in the cLDA model include treatment, time in weeks (categorical), regions, and treatment-by-time interaction.|Phase 2 Baseline (Week 20) and Week 44|Per-Protocol (PP) population - excluded those participants who were identified as protocol violators and those who were non-compliant with Good Clinical Practice (GCP) requirements.|||Percent||95% Confidence Interval|Least Squares Mean
2645774|NCT01709227|Secondary|Modified Oxygenation Index|Product of Mean airway pressure delivered by mechanical ventilation and FiO2 of administered oxygen|at 24 and 48 hours postoperative||||Units||Inter-Quartile Range|Median
2645775|NCT01709227|Secondary|B-Natriuretic Peptide|BNP measured at 24 and 48 hours postoperatively|At 24hours and 48 hours postoperative||||pg/ml||Inter-Quartile Range|Mean
2645776|NCT01709227|Secondary|Doses of Potassium Chloride or Arginine Chloride Required|Total doses of potassium chloride or arginine chloride given during the first five postoperative days.|Postop day 0-5||||doses given||Inter-Quartile Range|Median
2645777|NCT01709227|Secondary|Renal/Electrolyte Abnormalities|Total sum of renal and electrolyte abnormalities over the first 5 postoperative days as defined in the protocol|Postop morning 1-5||||abnormalities||Inter-Quartile Range|Median
2645778|NCT01709227|Secondary|All Cause Mortality|In-hospital mortality|duration of hospitalization (an average of 2 weeks)||||Participants|||Count of Participants
2645779|NCT01709227|Secondary|Duration of Hospital Stay|Total days of initial postoperative stay in hospital|Average 4 weeks||||days||Inter-Quartile Range|Median
2645781|NCT01709227|Secondary|NGAL Concentration||Pre-op, and postop (2hr, 6hr, 12hr, 24hr, 48hr)|Data were collected but not analyzed. Due to a high incidence of volatile and un-reportable NGAL levels, concerns were raised about the storage or processing of samples affecting data validity. Given the overwhelming concern of erroneous data, analysis was not performed as planned.||||||
2645782|NCT01709227|Secondary|Respiratory Support Administered|Duration of initial course of postoperative mechanical ventilation|Duration of postoperative intubation (average time approximately- 1 week)||||days||Inter-Quartile Range|Median
2645783|NCT01709227|Primary|Number of Participants With Negative Fluid Balance on Postop Day 1|Difference of inputs and outputs, including urine output and PD drainage.|Postop day 1||||Participants|||Count of Participants
2645784|NCT01709162|Other Pre-specified|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Immune-related AEs (irAEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|From Day 1 of treatment to 90 days after last dose (or to death date for death information)|All participants who received at least 1 dose of study drug|||Participants|||Number
2645785|NCT01709162|Secondary|Best Overall Response Rate (BORR)|BORR is defined per arm as the total number of randomized patients with a best overall response of complete response or partial response, divided by the total number of randomized patients in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined timeframe. Because the study ended before best overall response for all patients was defined, no participant data was analyzed.|Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease|All participants who were randomized||||||
2645786|NCT01709162|Secondary|Disease Control Rate (DCR)|DCR is defined per arm as the total number of randomized participants with best overall response as complete response, partial response, or stable disease, divided by the total number of randomized participants in the arm. Bristol-Myers Squibb terminated this study early because the study would not meet its scientific objective in the predefined time frame. Thus, no participants were analyzed. Because the study ended before best overall response could be determined, no participants were analyzed.|Every 3 months for approximately 3.5 years after start of randomization and then every 6 months until confirmed and documented progressive disease|All participants who were randomized||||||
2645787|NCT01709162|Primary|Overall Survival|Overall survival is defined for each patient as the time between randomization and death. If a patient has not died, he or she will be censored at the time of last contact (last known alive date)|From randomization to death or last known alive date, assessed up to 15.6 months|All participants who were randomized|||Months||Full Range|Median
2645788|NCT01709149|Secondary|Change From Baseline in Muscle Strength Mega-Score Based on Percent Change in Muscle Strength Measurements to the Average at the End of Weeks 8 and 12 of Double-blind Treatment|A hand-held dynamometer (HHD), with a scale of 0 to 300 pounds, was used to measure muscle strength and handgrip strength (bilateral); the muscle groups tested were: elbow flexion (bilateral), wrist extension (bilateral), knee extension (bilateral), and ankle dorsiflexion (bilateral). For each assessment time point, the percent change from baseline was calculated for each muscle group and handgrip strength. The muscle strength mega-score was calculated as the average of the changes (ie, percent change from baseline) observed for each muscle groups as well as handgrip strength. For this endpoint, negative values indicate a decline in muscle strength.|Baseline, 8 weeks, 12 weeks||||percent change||Standard Error|Least Squares Mean
2645789|NCT01709149|Secondary|Change From Baseline in Handgrip Fatigability (at 60% of Target in the Weaker Hand) to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment|Handgrip fatigability was measured immediately following determination of maximum handgrip strength (via an electronic hand dynamometer). Once maximum handgrip strength was achieved, the force of the grip was timed for 2 minutes or until the grip strength had dropped to 60% of the maximum, whichever came first.|Baseline, 8 weeks, 12 weeks|Modified Full Analysis Set|||seconds||Standard Error|Least Squares Mean
2645790|NCT01709149|Secondary|Change From Baseline in Maximum Handgrip Strength in the Weaker Hand to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment|Maximum handgrip strength was measured using an electronic hand dynamometer; patients were asked to squeeze the device with the maximum possible force.|Baseline, 8 weeks, 12 weeks||||pounds||Standard Error|Least Squares Mean
2645791|NCT01709149|Secondary|Change From Baseline in Slow Vital Capacity (SVC) to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment|SVC was measured using a spirometer (in units of liters). Following 3 to 5 breaths at rest, the patients were instructed to take as deep an inspiration as possible followed by a maximum exhalation (blowing out all the air in their lungs). Values obtained were converted to % predicted values (ie, the test result as a percent of predicted values for the patients of similar demographic and baseline characteristics [eg, height, age, sex]).|Baseline, 8 weeks, 12 weeks|Modified Full Analysis Set|||% predicted||Standard Error|Least Squares Mean
2645792|NCT01709149|Secondary|Change From Baseline in Sniff Nasal Inspiratory Pressure (SNIP) to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment|SNIP was measured at functional residual capacity, the bottom of the tidal breathing cycle, through 1 plugged nostril while the other remained open. Inspiratory pressure is a negative number where a larger negative number represents . . . A forceful, maximal inspiratory sniff was performed and a peak pressure value reported. The best result (ie, the highest number) from 5 tests was recorded as the SNIP.|Baseline, 8 weeks, 12 weeks|Modified Full Analysis Set|||cm H2O||Standard Error|Least Squares Mean
2645793|NCT01709149|Secondary|Change From Baseline in Maximum Voluntary Ventilation (MVV) to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment|MVV was measured as the volume (in liters) of air that could be exhaled during 12 seconds of rapid deep breathing; for analysis purposes, the measured volume was extrapolated to 1 minute (to give units of L/min).|Baseline, 8 weeks, 12 weeks|Modified Full Analysis Set|||L/min||Standard Error|Least Squares Mean
2668471|NCT01505764|Secondary|1-repetition Max. Strength|leg extension - percentage of change day 84 to baseline|day 84|only two subjects in each group completed this outcome|||percentage change||Standard Deviation|Mean
2645794|NCT01709149|Primary|The Change From Baseline in ALS Functional Rating Scale-Revised (ALSFRS-R) Total Score to the Average of Values Obtained at the End of Weeks 8 and 12 of Double-blind Treatment|The ALSFRS-R is used to measure the progression and severity of disease; it consists of 12 questions, assessing a patient's capability and independence in functional activities relevant to ALS, categorized in 4 domains: gross motor tasks, fine motor tasks, bulbar functions, and respiratory function. Each question is scored from 0 (indicating incapable or dependent) to 4 (normal). The total score ranges from 0 to 48, with higher scores reflecting more normal function and lower scores reflecting more impaired function.|Baseline, 8 weeks, 12 weeks|Modified Full Analysis Set|||units on a scale||Standard Error|Least Squares Mean
2645795|NCT01709136|Secondary|SRL Prevent TAC-related Side Effects|Whether SRL can prevent or minimize progression of selected TAC-related side-effects such as renal dysfunction as measured by clearance of iothalamate (Glomerular filtration rate < 80 mL/min/1.73 m2) and hypertension (blood pressure > 140/90 mm Hg)|1 year|Due to FDA blackbox warnings from FDA (6/11/2009) about Sirolimus in liver transplant recipients (risk of thrombosis and death), the study was terminated early and data analysis was not able to be completed.||||||
2645796|NCT01709136|Primary|Early and Late Pharmacokinetics of Sirolimus (SRL)|To evaluate early and late pharmacokinetics of Sirolimus (SRL) , and safety and efficacy of conversion from tacrolimus (TAC) to sirolimus in liver transplant recipients who have been stable for at least 3 months, and who have early nephrotoxicity and/or hypertension due to use of tacrolimus.|1 year|Three pharmacokinetics (PK) profiles were performed, one in each of three patients who were enrolled. However, due to FDA blackbox warnings (6/11/2009) about Sirolimus in liver transplant recipients be circumspect (risk of thrombosis and death), the study was terminated early and data analysis was not able to be completed.||||||
2645797|NCT01709136|Secondary|SRL Can Substitute TAC|Whether Sirolimus can substitute Tacrolimus in the stable post-transplant state, without compromising allograft function|12 months|Due to FDA blackbox warnings (6/11/09) about Sirolimus in liver transplant recipients (risk of thrombosis and death), the study was terminated early. Due to the early termination of this study and small number of subjects enrolled (3), data analysis was not able to be completed.||||||
2645798|NCT01709136|Secondary|PK Parameters for Tacrolimus and Sirolimus|pharmacokinetics (PK) of SRL after a single dose and after steady state has been achieved; and the pharmacokinetics of tacrolimus once at steady state|12 months|We were able to preform 3 pharmacokinetics (PK) profiles, one in each of three patients enrolled. However, due to emerging data and blackbox warnings from FDA suggesting that use of Sirolimus in liver transplant recipients be circumspect (risk of thrombosis and death), the study was terminated early and data analysis was not able to be completed.||||||
2645799|NCT01709110|Secondary|Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (US)|The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United States (US) cross walk algorithm, with scores ranging from -0.11 to 1.0. A higher score indicates better health state.|Baseline, 24 Months|Full analysis set: all participants who received at least one dose of study drug and had evaluable data.|||units on a scale||Standard Deviation|Mean
2645800|NCT01709110|Secondary|Change From Baseline to 24 Months Endpoint in the European Quality of Life Questionnaire [EQ-5D-5L] (UK)|The EQ-5D-5L is a generic, multidimensional, health-related, quality-of-life instrument completed on five dimensions to measure health-related quality of life. The profile allowed participants to rate their health state in five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a five level scale (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems). The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.59 to 1.0. A higher score indicates better health state.|Baseline, 24 Months|Full analysis set: all participants who received at least one dose of study drug and had evaluable data.|||units on a scale||Standard Deviation|Mean
2645801|NCT01709110|Secondary|Change From Baseline to 24 Months Endpoint in Back Pain Using an 11-point Numerical Pain Rating Scale|Participants rated the worst back pain during the 24 hours preceding the visit at baseline and each post-baseline visit. An 11-point numerical back pain rating scale (rated from 0 = no back pain to 10 = worst possible back pain) was used.|Baseline, 24 Months|Full analysis set: all participants who received at least one dose of study drug and had evaluable data.|||units on a scale||Standard Deviation|Mean
2645802|NCT01709110|Secondary|Change From Baseline to 24 Months Endpoint in Height||Baseline, 24 Months|Full analysis set: all participants who received at least one dose of study drug and had evaluable data.|||Centimeter (cm)||Standard Deviation|Mean
2645803|NCT01709110|Secondary|Proportion of Participants With Pooled Fragility and Traumatic Non-Vertebral Fractures|Traumatic fractures were considered if resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object.|Baseline through 24 Months|Full analysis set: all participants who received at least one dose of study drug and had evaluable data.|||Participants (with at least one event)|||Number
2645804|NCT01709110|Secondary|Proportion of Participants With New Multiple (2 or More) Vertebral Fractures||Baseline through 24 Months|Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.|||Participants (with at least one event)|||Number
2645805|NCT01709110|Secondary|Proportion of Participants With New Moderate and/or Severe Vertebral Fractures|Vertebrae were graded as moderate (SQ2), or severe (SQ3) fractures, based on ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 through L4).|Baseline through 24 Months|Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.|||Participants (with at least one event)|||Number
2645875|NCT01708161|Secondary|Cmax of AMG - Phase Ib|"Serum concentration for AMG 479 (ganitumab)~1 cycle - 28 days of treatment"|Cycle 1 Day 15|Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received.|||ng/mL||Standard Deviation|Mean
2645806|NCT01709110|Secondary|Proportion of Participants With Major Non-Vertebral Fragility Fractures|A major non-vertebral fracture is a fracture at any of the following non-vertebral sites hip, radius, humerus, ribs, pelvis, tibia and femur. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving.|Baseline through 24 Months|Full analysis set: all participants who received at least one dose of study drug and had evaluable data.|||Participants (with at least one event)|||Number
2645807|NCT01709110|Secondary|Proportion of Participants With Non-Vertebral Fragility Fractures|A non-vertebral fracture is a fracture at any of the following non-vertebral sites: clavicle, scapula, ribs, sternum, sacrum, coccyx, humerus, radius, ulna, carpus, pelvis, hip, femur, patella, tibia, fibula, ankle, calcaneus, tarsus, and metatarsal. Non-vertebral fractures were determined by direct questioning at each visit, and confirmed by the site investigators by x-ray, radiology or surgical report. Fractures resulting from a severe trauma such as a traffic collision, a beating, or having been struck by a falling or moving object were not considered fragility fractures but traumatic fractures.|Baseline through 24 Months|Full analysis set: all participants who received at least one dose of study drug and had evaluable data.|||Participants (with at least one event)|||Number
2645808|NCT01709110|Secondary|Proportion of Participants With Pooled Clinical Vertebral and Non-Vertebral Fragility Fractures|"A clinical vertebral fracture was defined as a new or worsening vertebral fracture, confirmed by radiography, that was associated with signs and symptoms highly suggestive of a vertebral fracture.~All non-vertebral fractures that occurred and were diagnosed between visits required the confirmation by the site investigators after evaluating the original x-ray film(s), the radiology or surgical report. For clinical vertebral fractures, the final confirmation of the diagnosis required the centralized evaluation by a trained, independent reader."|Baseline through 24 Months|Full analysis set: all participants who received at least one dose of study drug and had evaluable data.|||Participants (with at least one event)|||Number
2645809|NCT01709110|Secondary|Proportion of Participants With Pooled New and Worsening Vertebral Fractures|Worsening of a pre-existing fracture was considered if the decrease in vertebral height was at least one severity grade in the semi-quantitative assessment, confirmed by a trained central reader, where vertebrae were graded as normal (SQ0) or as with mild (SQ1), moderate (SQ2), or severe (SQ3) fractures, defined as ~20 to 25% (mild), ~25 to 40% (moderate) or ~40% or more (severe) decrease in anterior, central, or posterior vertebral height (T4 to L4).|Baseline through 24 Months|Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.|||Participants (with at least one event)|||Number
2645810|NCT01709110|Primary|Proportion of Participants With New Vertebral Fractures|"The incidence of new vertebral fractures was assessed by quantitative vertebral morphometry measurements (QM) with qualitative visual semiquantitative grading (SQ) confirmation.~A new vertebral fracture was diagnosed in a vertebra that was non-fractured at the baseline radiological examination. It was defined as a loss of vertebral body height of at least 20% and 4 mm from the baseline radiograph by vertebral QM, based upon placement of six points by a trained, central reader. Any fractures identified by QM were confirmed using SQ: if the vertebral body also had an increase of one or more severity grade, it was considered an incident vertebral fracture."|Baseline through 24 Months|Full analysis set-modified: participants with baseline and at least one post-baseline spinal radiograph evaluable to assess the vertebral fracture status after 24 month of therapy.|||Participants (with at least one event)|||Number
2645811|NCT01709084|Secondary|Number of Participants With Treatment-Emergent Nucleoside Reverse Transcriptase Inhibitor (N[t]RTI) or Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (NNRTI) Mutations|To compare the loss of treatment options, the number of participants with treatment-emergent N[t]RTI or NNRTI mutations, as defined by IAS-USA (2014), after virologic failure were compared between the treatment groups.|Up to Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.|||Participants|||Number
2645812|NCT01709084|Secondary|Percentage of Participant With Treatment Adherence Based on Tablet Count|In both treatment groups adherence rates assessed by tablet count, the majority of participants had an adherence of >95% (97% and 98% in RPV and EFV treated treatment groups respectively).|Up to 48 Weeks|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2645813|NCT01709084|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels >= 50 Copies Per Milliliter (Copies/mL) at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.|Percentage of participants with plasma HIV-1 RNA levels analysed based on TLOVR imputation method which is defined as confirmed plasma HIV-1 RNA >=50 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression <50 copies/mL.|Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2645814|NCT01709084|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels More Than or Equal to (>=) 400 Copies/mL at Week 48 Based on Time to Loss of Virologic Response (TLOVR) [Non-virologic Failure Censored] Imputation Method.|Percentage of participants with plasma HIV-1 RNA levels analysed based on time to loss of virologic response (TLOVR) imputation method which is defined as confirmed plasma HIV-1 RNA >=400 copies/mL, excluding participants who discontinued the study with HIV-1 RNA suppression <400 copies/mL.|Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2645815|NCT01709084|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels < 50 Copies/mL at Week 48|Percentage of Participants with plasma HIV-1 RNA <50 copies/mL, obtained by the modified Food and Drug Administration (FDA) Snapshot method.|Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.|||Percentage of Participants|||Number
2668472|NCT01505764|Secondary|Stair Climbing Power|Percent change from baseline|day 84|only two subjects in each group completed this outcome|||percentage change||Standard Deviation|Mean
2645816|NCT01709084|Primary|Percentage of Participants With Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 400 Copies Per Milliliter (Copies/mL) at Week 48|Percentage of Participants with viral load (plasma HIV-1 RNA levels) less than 400 copies per mL at Week 48, obtained by the modified Food and Drug Administration (FDA) Snapshot method.|Week 48|The intent-to-treat (ITT) population included all participants who were randomized and who had taken at least 1 dose of study drug.|||Percentage of Participants|||Number
2645817|NCT01709032|Secondary|Number of Participants With Improvement in Cardiac T2* MRI|Improvement in Cardiac T2* MRI from baseline to determine if there is a reduction of cardiac iron burden.|12 months|Number of participants with improvement|||Participants|||Count of Participants
2645818|NCT01709032|Primary|Number of Participants With Improvement in Liver Iron Concentration|Determine the safety of the combination of Deferasirox and Deferiprone for the treatment of subjects with Thalassemia Major and Severe Iron Overload by assessing change in liver iron concentration from baseline to follow-up|12 months|Number with participants with improvement in liver iron concentration|||Participants|||Count of Participants
2645819|NCT01708967|Primary|Success Rate of Transnasal Endoscopy|"We difine the success of transnasal endoscopy as follows: the pateint underwent transnasal endoscopy without signicant complaint nor side effects.~We difine the failure of transnasal endoscopy as follows: the patient cannot tolerate insertion of the endoscope; the patient presents side effects such as epistaxis, pain, or a decrease in O2 saturation; and the endoscope cannot pass through the nasal or oral cavity."|During transnasal endoscopy, up to 1 hours||||percentage of Participants||95% Confidence Interval|Number
2645820|NCT01708967|Other Pre-specified|Satisfaction|Patients were asked to score how well they felt during endoscopy using a visual analog scale; they were also asked whether they would accept one-time spray method or spray+catheter method in the future if necessary.|after transnasal endoscopy|||||||
2645821|NCT01708967|Secondary|Vital Signs|Blood pressure, heart rate, and O2 saturation were assessed.|before, during, and after transnasal endoscopy|||||||
2645822|NCT01708954|Secondary|Proportion of Patients With Worst Grade Toxicities of Grade 3 or Higher||Assessed every 4 weeks while on treatment and for 30 days after the end of treatment|All patients who received protocol therapy|||Proportion of participants||90% Confidence Interval|Number
2645823|NCT01708954|Secondary|Proportion of Patients With MET Positivity|Submission of archival tissue for central MET IHC testing was required for this study, and total MET IHC testing was conducted at the Brigham and Women's Hospital using the c-Met clone CVD13 (arabbit polyclonal). Membranous and cytoplasmic staining were individually scored, and positivity was declared if MET was expressed in either the membrane or cytoplasm.|Assessed at baseline|Eligible and treated patients who had sufficient samples for MET expression analysis.|||proportion of participants||95% Confidence Interval|Number
2645824|NCT01708954|Secondary|Proportion of Patients With Objective Response|Objective response is defined as complete response (CR) or partial response (PR) evaluated using RECIST v 1.1. CR is defined as disappearance of all lesions and any pathological lymph nodes must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions and persistence of one or more non-target lesion(s).|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years|Eligible and treated patients|||proportion of participants||95% Confidence Interval|Number
2645825|NCT01708954|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to death from any cause or date of last known alive.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years|Eligible and treated patients|||months||95% Confidence Interval|Median
2645826|NCT01708954|Primary|Progression-free Survival (PFS)|PFS is defined as the time from randomization to documented disease progression or death from any cause, whichever occurred first. Patients who had not experienced an event of interest by the time of analysis were censored at the date of last disease assessment.|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry, up to 5 years|Eligible and treated patients|||months||95% Confidence Interval|Median
2645827|NCT01708941|Other Pre-specified|Immune-related Response Rate Per Immune-related Response Criteria|Defined as the number of complete and partial responses per immune-related response criteria (irRC) divided by the total number of evaluable patients|Assessed every 12 weeks for 3 years|||||||
2645828|NCT01708941|Other Pre-specified|Clinical Response Rate|Defined as the number of complete responses and partial responses per RECIST version 1.1 divided by the total number of evaluable cases|Assessed every 12 weeks for 3 years|||||||
2645829|NCT01708941|Secondary|Overall Survival|Time from randomization to death (event), or censored at last date known alive.|Assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 years|Eligible patients who started treatment; OS comparison of higher dose ipilimumab versus lower dose ipilimumab across HDI status (Arms A & B versus Arms C & D)|||months||95% Confidence Interval|Median
2645830|NCT01708941|Secondary|Overall Survival (OS)|Time from randomization to death (event), or censored at last date known alive|Assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 years|Eligible patients who started treatment; OS comparison of ipilimumab + HDI versus ipilimumab alone, across ipilimumab doses (Arms A & C versus Arms B & D)|||months||95% Confidence Interval|Median
2645831|NCT01708941|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as time from randomization to any documented disease progression or death from any cause, whichever occurred first (event), or censored at last date known alive.|Assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 years|Eligible patients who started treatment; PFS comparison of higher dose ipilimumab versus lower dose ipilimumab across HDI status (Arms A & B versus Arms C & D)|||months||95% Confidence Interval|Median
2645832|NCT01708941|Primary|Progression-free Survival (PFS)|Progression-free survival (PFS) was defined as time from randomization to any documented disease progression or death from any cause, whichever occurred first (event), or censored at last date known alive.|Assessed every 3 months for two years, then every 6 months for 3 years, then every 12 months for up to 10 years|Assessed among eligible patients who started treatment. The primary objective of the study is to compare PFS on the combination of ipilimumab + HDI (Arms A & C) versus ipilimumab alone (Arms B & D), across ipilimumab treatment status. Thus data across arms are combined.|||months||95% Confidence Interval|Median
2645833|NCT01708915|Secondary|Patient Assessment of Efficacy on the Last Individual Treatment Day|Patient assessment of efficacy was assessed on a 4-point verbal rating scale (VRS, 0 = 'poor', 1 = 'fair', 2 = 'good', 3 = 'very good' relief of the patients' low back pain) in the evening of days 1, 2, 3 and 4. The last individual treatment day is the last day with diary-recorded ointment application|1 to 4 days|Patients from FAS.|||participants|||Number
2645834|NCT01708915|Secondary|Difference Between Baseline Pain Intensity and Average Pain Intensity on the Last Individual Treatment Day|Average pain intensity was assessed in the evening of days 1, 2, 3 and 4 on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible). The last individual treatment day is the last day with diary-recorded ointment application. Means were adjusted for centre effect and baseline value.|Baseline and 1 to 4 days|Patients from FAS with evaluable data for the pain intensity at baseline and for the avarage pain intensity on the last individual treatment day.|||units on a scale||Standard Error|Least Squares Mean
2645835|NCT01708915|Secondary|Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application|Pain intensity was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3 and 4 hours after first ointment application. Means were adjusted for centre effect and baseline value.|Baseline and 4 hours after first ointment application|Patients from FAS.|||units on a scale||Standard Error|Least Squares Mean
2645836|NCT01708915|Primary|Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application|Pain intensity (PI) was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3, 4, 6 and 8 hours after first ointment application. Means were adjusted for centre effect and baseline value.|Baseline and 8 hours after first ointment application|Patients from the Full Analysis Set (FAS): all randomised patients who used at least 1 dose of study medication and provided any post-treatment data for the pain intensity difference within 8 hours after first application.|||units on a scale||Standard Error|Least Squares Mean
2645837|NCT01708902|Secondary|The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG|The Frequency of Patients With Use of Rescue Therapy During 12 Week Treatment Period in APG.|From baseline until week 12|FAS|||percentage of participants||95% Confidence Interval|Number
2645838|NCT01708902|Secondary|The Frequency of Patients With Use of Rescue Therapy During 24 Week Treatment Period in Main Group|"The frequency of patients with use of rescue therapy during 24 week treatment period in main group.~For this analysis the main group contrast 'Metformin 1000mg BID, Linagliptin 2.5mg / Metformin 1000mg BID' could not be analysed due to lack of events in the Metformin 1000mg BID group."|From baseline until week 24|FAS|||percentage of participants||95% Confidence Interval|Number
2645839|NCT01708902|Secondary|The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG|"The Change in Fasting Plasma Glucose (FPG) From Baseline After 12 Weeks of Treatment in APG.~Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group."|Baseline and week 12|FAS (LOCF)|||mg/dL||Standard Error|Mean
2645840|NCT01708902|Secondary|The Change in Fasting Plasma Glucose (FPG) From Baseline After 24 Weeks of Treatment in Main Group|"The change in fasting plasma glucose (FPG) from baseline after 24 weeks of treatment in main group.~Adjusted mean: The model includes continuous baseline HbA1c, continuous baseline FPG and treatment group."|Baseline and week 24|FAS (LOCF)|||mg/dL||Standard Error|Mean
2645841|NCT01708902|Secondary|The Occurrence of Relative Efficacy Response in APG|The Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 12 Weeks of Treatment) in APG|From baseline until week 12|FAS (NCF)|||percentage of participants||95% Confidence Interval|Number
2645842|NCT01708902|Secondary|The Occurrence of Relative Efficacy Response in Main Group|The occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment) in main group|From baseline until week 24|FAS (NCF)|||percentage of participants||95% Confidence Interval|Number
2645843|NCT01708902|Primary|The Change From Baseline in HbA1c After 12 Weeks of Treatment in APG|"The change from baseline in HbA1c after 12 weeks of treatment in additional parallel group (APG)~The mean was adjusted by baseline HbA1c and treatment group."|Baseline and week 12|FAS (LOCF)|||percentage||Standard Error|Mean
2645844|NCT01708902|Primary|The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group - FAS (OC)|"The change from baseline in HbA1c after 24 weeks of treatment in main group. Only subjects from the FAS with measured HbA1c values (observed cases [OC]) were considered.~The mean was adjusted by treatment, baseline HbA1c, week and treatment*week.~The sensitivity analysis was added as the primary analysis failed with borderline results."|Baseline and week 24|FAS (OC): subjects from the FAS with measured HbA1c values (observed cases [OC]) were considered|||percentage||Standard Error|Mean
2645845|NCT01708902|Secondary|The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 12 Weeks of Treatment in APG|The occurrence of treat to target efficacy response in terms of HbA1c < 6.5% after 12 weeks of treatment in APG.|Week 12 (after first drug administration)|FAS (NCF)|||percentage of participants||95% Confidence Interval|Number
2645846|NCT01708902|Secondary|The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 6.5% After 24 Weeks of Treatment in Main Group|The occurrence of treat to target efficacy response in terms of HbA1c < 6.5% after 24 weeks of treatment in main group.|Week 24 (after first drug administration)|FAS (NCF)|||percentage of participants||95% Confidence Interval|Number
2645847|NCT01708902|Secondary|The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 12 Weeks of Treatment in APG|The occurrence of treat to target efficacy response in terms of HbA1c < 7.0 % after 12 weeks of treatment in APG.|Week 12 (after first drug administration)|FAS (NCF)|||percentage of participants||95% Confidence Interval|Number
2645848|NCT01708902|Secondary|The Occurrence of Treat to Target Efficacy Response in Terms of HbA1c < 7.0 % After 24 Weeks of Treatment in Main Group|The occurrence of treat to target efficacy response in terms of HbA1c < 7.0 % after 24 weeks of treatment in main group.|Week 24 (after first drug administration)|FAS - non-completers were considered as nonresponders (NCF)|||percentage of participants||95% Confidence Interval|Number
2645874|NCT01708161|Secondary|Area Under Curve (AUC) 0-336 Hour of AMG - Phase Ib|"Area under curve for AMG 479 (ganitumab)~1 cycle - 28 days of treatment"|Cycle 1 Day 15 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose)|Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received.|||hr*ng/mL||Standard Deviation|Mean
2645849|NCT01708902|Primary|The Change From Baseline in HbA1c After 24 Weeks of Treatment in Main Group|"The change from baseline in HbA1c after 24 weeks of treatment in main group.~The mean was adjusted by baseline HbA1c and treatment group."|Baseline and week 24|Full analysis set (FAS): all randomised and treated patients who had a baseline and at least 1 on-treatment HbA1c value As the imputation rule for missing data the last observation carried forward (LOCF) was used.|||percentage||Standard Error|Mean
2645850|NCT01708629|Primary|Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo|Static Physician Global Assessment (sPGA) measures the physician's impression of the disease. Possible scores are (0 [clear] to 5 [severe]). Success was defined by a score of 0 or 1 (clear to almost clear).|12 weeks|sPGA was only assessed as a comparison of Brodalumab (210mg and 140mg) to Placebo.|||Participants|||Count of Participants
2645851|NCT01708629|Primary|Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12|The Psoriasis Area and Severity Index Score is used as a scale to show change from Baseline of study to a certain point. PASI Score ranges from (0) no disease to (72) maximal disease. The proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75, was assessed.|12 weeks||||Participants|||Count of Participants
2645852|NCT01708603|Primary|Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12|to evaluate the efficacy of Brodalumab (210mg Q2W) in clearing psoriasis as measured by the proportion of subjects achieving PASI 100 at week 12.|12 Weeks||||Participants|||Count of Participants
2645853|NCT01708603|Primary|Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12|to evaluate the efficacy of Brodalumab (210mg every 2 weeks, and 140mg every 2 weeks) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects achieving 75% improvement in Psoriasis Area and Severity Index, PASI75 at week 12.|12 weeks||||Participants|||Count of Participants
2645854|NCT01708603|Primary|Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12|Measures the physician's impression of the disease at a single point, and a dynamic form in which the physician assesses the global improvement from baseline. Success is defined by a score of 0 or 1 (clear to almost clear).|12 weeks||||Participants|||Count of Participants
2645855|NCT01708590|Secondary|Percentage of Participants With Static Physicians Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 52|to evaluate maintenance of effect with continued brodalumab treatment (210mg Q2W, 140mg Q2W) as measured by the proportion of subjects achieving success (clear[0] or almost clear [1]) at week 52.|Week 0 - Week 52|Only subjects with efficacy data available at Week 52 were included in the analysis.|||Participants|||Count of Participants
2645856|NCT01708590|Primary|Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12|To evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis , as measured by the proportion of subjects who achieved success (clear [0] or almost clear [1]) on the static physicians global assessment (sPGA) at week 12|0 - 12 Weeks|Data reported is based off of the data collected from the induction phase|||Participants|||Count of Participants
2645857|NCT01708590|Primary|Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12|to evaluate the efficacy of brodalumab (210mg Q2W, 140mg Q2W) in subjects with moderate to severe plaque psoriasis, as measured by the proportion of subjects who achieved 75% improvement in Psoriasis Area Severity Index (PASI75) at week 12.|0-12 weeks|Data collected is based off of the data from the induction phase.|||Participants|||Count of Participants
2645858|NCT01708525|Primary|Rate of Collagen Synthesis|Resected tissue will be analyzed to determine the rate of collagen synthesis in tissue treated with Ultherapy® compared to non-treated tissue.|4 weeks post-treatment||||percentage of new collagen synthesized|||Number
2645859|NCT01708317|Primary|Gonorrhea and Chlamydia Testing in the Pediatric ED|"The primary outcome was change in the proportion of adolescent patients receiving chlamydia and gonorrhea testing rates during their ED visit over 4 time periods.~Period 1) 2010 testing as a historical control Period 2) Jan 2011, began providing staff education about the risks of gonorrhea/chlamydia and need for increased testing Period 3) Education continues, but enrolled patients in the ACASI from April 18, 2011 - Dec 20, 2011.~Period 4) ACASI enrollment completed, education continued through March 2012~We specifically analyzed gonorrhea/chlamydia testing among ED patients that would have been eligible to take the ACASI, had it been continuously available throughout these time periods. We did this to isolate the effects on testing by the ACASI vs. education alone."|27 months|We analyzed every patient in this time period that met our ACASI inclusion/exclusion criteria|||percentage of participants|||Number
2645860|NCT01708291|Primary|Number of Participants Reporting Pediatric Symptoms as Assessed by the Pediatric Symptom Checklist-17 (PSC-17)|Self Administered questionnaire to assess level of stress at baseline and week 10. PSC-17 is a one page behavioral assessment tool that can be completed in <5 minutes and can assess the sub-domains of attention, externalizing problem and internalizing problems. Attention, externalizing and Internalizing domains are each scored on a scale from 0 (best) to 10 (worst), where a score >= 7 indicates stress.|Baseline and week 10||||participants|||Number
2645861|NCT01708278|Primary|Participants Who Experienced Safety Concerns, Where Safety Concerns of Quercetin Supplementation is Indicated by Significant Change From Baseline Measures of Tests Indicated Below in Outcome Measure Description|"Note: If values for any of the measures indicated here were found, the participant would be indicated as a participant with a safety concern, and values for that particular measure would be posted specifically, but since none of the participants experienced these outlying values, results of all tests are expressed here as a composite function.~PULMONARY FUNCTION TEST:~FEV1% of predicted: decline by >20% from baseline COMPLETE BLOOD COUNTS: WBC (cells)/mm3 : <2000, Platelets (cells)/mm3: <25,000, Hemoglobin (g/dL): <7.0 COMPREHENSIVE METABOLIC PROFILE (study drug related):Sodium (mmol/L): <125 or >148, Potassium (mmol/L): < 3.0 or > 6.0, Calcium (mmol/L): <7.4 or > 11.5, LIVER FUNCTION TESTS INCREASE BY FACTOR: Enzymes ALT, AST, and Alkaline phosphate, Total bilirubin: for any of these a value >3X upper limit of normal"|One week in Phase I safety study||||Participants|||Count of Participants
2645862|NCT01708213|Secondary|Percentage of Participants That Were Satisfied With the Treatment as Rated by GAIS|This was measured using the Global Aesthetic Improvement Scale (GAIS). With the Global Aesthetic Improvement Scale (GAIS Scale) results of 1, 2 and 3 at 6 months were considered satisfied in this study.|6 months||||percentage of participants|||Number
2645863|NCT01708213|Secondary|Number of Participants With a Decrease in the Wrinkle Severity Scale for Nasolabial Folds|"For this study, a decrease (at least one point) in the rating, relative to pre-treatment rating, when assessed by Investigators at the 1-Month, 3-Month, and 6-Month visits was considered clinically significant (P value less than 0.05).~WSS:~(0) - No wrinkle~- Just perceptible wrinkle~- Shallow wrinkle~- Moderately deep wrinkle~- Deep wrinkle, well-defined edges~- Very deep wrinkle, redundant fold"|6 months|Wrinkle Severity Score (WSS) assessment values of the Nasolabial Folds treatment area for the Per Protocol population (N=10) is a subgroup of the N=43 per protocol subjects treated. Reporting on the subjects with a 1 point improvement on the WSS at 6 months time.|||participants|||Number
2645864|NCT01708213|Primary|Assessment of Treatment Site Responses Post Procedure|The primary endpoint of this study is to assess treatment site responses and adverse events through 6 months post procedure.|6 months||||percentage of participants with any AE|||Number
2645865|NCT01708187|Primary|Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months|"Ankle pain measured via visual analog scale (VAS), function measured by American Orthopaedic Foot and Ankle Society (AOFAS) ankle hindfoot scale and Foot Function Index (FFI), activity limitation measured by AOFAS scale. Images taken via thermal camera to measure inflammation were not interpretable.~VAS pain scale: 0-100, with a lower number representing a better score FFI scale: 0-100, with a lower number representing a better score AOFAS scale: 0-100, with a higher number representing a better score"|Baseline,12 months||||units on a scale|||Number
2645866|NCT01708174|Secondary|Pharmacokinetics (PK): Summary of Plasma Trough Concentrations for Sonidegib (LDE225)|Blood samples were collected for assessment. The children's group was analyzed up until week 25 only.|Weeks 1, 3, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49 and 53|The full analysis set (FAS) was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.|||ng/mL||Standard Deviation|Mean
2645867|NCT01708174|Secondary|Overall Survival (OS) From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016|OS was defined as the time from date of randomization to date of death due to any cause. All deaths are considered, including deaths occurred after crossover for TMZ participants.|from date first participant randomized, 13-Sep-2013 to date of data cut-off, 15-Nov-2016|The full analysis set (FAS) was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.|||months||95% Confidence Interval|Median
2645868|NCT01708174|Secondary|Duration of Response (DoR) According to Local Investigator Assessment From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016|DoR was defined as the time from the first documented onset of confirmed PR or CR to the date of PD/relapse or death due to medulloblastoma. DoR was evaluated by local Investigator assessment per tumor response guidelines and criteria for Medulloblastoma. TMZ participants without an event prior to crossover were censored.|from date first participant randomized, 13-Sep-2013 to date of data cut-off, 15-Nov-2016|The full analysis set (FAS) was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.|||months||95% Confidence Interval|Median
2645869|NCT01708174|Secondary|Percentage of Participants With ORR According to Local Investigator Assessment From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016|ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR). ORR was evaluated by local Investigator assessment per tumor response guidelines and criteria for Medulloblastoma. Assessments after crossover were not included for TMZ patients.|from date first participant randomized, 13-Sep-2013 to date of data cut-off, 15-Nov-2016|The full analysis set (FAS) was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2645870|NCT01708174|Secondary|PFS According to Local Investigator Assessment From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016|PFS was defined as the time from date of randomization to the date of event defined as the first documented progression or death due to any cause. PFS was evaluated by local Investigator assessment per tumor response guidelines and criteria for Medulloblastoma.|from date first participant randomized, 13-Sep-2013 to date of data cut-off, 15-Nov-2016|The FAS was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.|||months||95% Confidence Interval|Median
2645871|NCT01708174|Secondary|Progression Free Survival (PFS) According to IRC From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016|PFS was defined as the time from date of randomization to the date of event defined as the first documented progression or death due to any cause (as per tumor response guidelines and criteria for Medulloblastoma). The IRC evaluated all radiological images and applicable clinical data (i.e., neurological examination, steroid use and cerebrospinal fluid (CSF) results as applicable). TMZ participants without event prior to crossover were censored.|from date first participant randomized, 13-Sep-2013 to date of data cut-off, 15-Nov-2016|The FAS was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.|||months||95% Confidence Interval|Median
2645872|NCT01708174|Primary|Percentage of Participants With Overall Response Rate (ORR) According to Independent Review Committee (IRC) From Date First Participant Randomized, 13-Sep-2013 to Date of Data Cut-off, 15-Nov-2016|ORR was defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) (as per tumor response guidelines and criteria for Medulloblastoma). The IRC evaluated all radiological images and applicable clinical data (i.e., neurological examination, steroid use and cerebrospinal fluid (CSF) results as applicable). Assessments after crossover were not included for TMZ participants.|from date first participant randomized, 13-Sep-2013 to date of data cut-off, 15-Nov-2016|The full analysis set (FAS) was analyzed. The FAS included all randomized and non-randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2645873|NCT01708161|Secondary|Tmax and T Half of AMG - Phase Ib|"Tmax and half life of AMG 479 (ganitumab)~1 cycle - 28 days of treatment"|Cycle 1 Day 15|Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received.|||hr||Full Range|Median
2646251|NCT01704976|Secondary|Ismometric Maximal Voluntary Contraction (IMVC) Left Knee-extension|It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.|after 4 weeks||||Newton||Inter-Quartile Range|Median
2645876|NCT01708161|Secondary|Tmax and T Half of BYL - Phase Ib|"Tmax and half life of BYL719 (Alpelisib)~1 cycle - 28 days of treatment"|Cycle 1 Day 1, Cycle 1 Day 15|Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received.|||hr||Full Range|Median
2645877|NCT01708161|Secondary|Area Under Curve (AUC) 0-24 Hour of BYL - Phase Ib|"Area under curve for BYL719 (alpelisib)~1 cycle - 28 days of treatment"|Cycle 1 Day 1 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose), Cycle 1 Day 15 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose)|Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received.|||hr*ng/mL||Standard Deviation|Mean
2645878|NCT01708161|Secondary|Cmax of BYL - Phase Ib|"Serum concentration for BYL719 (alpelisib)~1 cycle - 28 days of treatment"|Cycle 1 Day 1, Cycle 1 Day 15|Pharmacokinetic analysis set (PAS). The PAS included all patients who had at least one blood sample providing evaluable PK data. Patients were analyzed according to the dose level they actually received.|||ng/mL||Standard Deviation|Mean
2645879|NCT01708161|Secondary|Percentage of Patients With Disease Control Rate (RECIST) Based on Investigator Radiology Assessment for HR Positive Breast and Ovarian Cancer - Phase II|"the antitumor activity of alpelisib in combination with ganitumab in patients with PIK3CA mutated or amplified hormone receptor positive (HR+) breast (arm 1) or ovarian (arm 2) cancer.~Phase II only, Cycle 1 Day 1 through Cycle 6 Day 28; assessed at baseline and every 8 weeks thereafter"|Approximately 1 year (since initiation of Phase II, Dec 2013, till Primary CSR cut off 06Jan2015)|Full analysis set|||Percentages of participants||95% Confidence Interval|Number
2645880|NCT01708161|Secondary|Percentage of Patients With Disease Control Rate (RECIST) Based on Investigator Radiology Assessment - Phase Ib|The anti-tumor activity of alpelisib and ganitumab in combination as per RECIST 1.1|Approximately 1 year (since FPFV 27Nov2012, till MTD declaration 26Nov2013)|Full Analysis set|||Percentages of participants||95% Confidence Interval|Number
2645881|NCT01708161|Secondary|Number of Patients With Best Overall Response (RECIST) Based on Investigator Radiology Assessment - Phase Ib|The anti-tumor activity of alpelisib and ganitumab in combination as per RECIST 1.1|Approximately 1 year (since FPFV 27Nov2012, till MTD declaration 26Nov2013)|Full Analysis set|||Participants|||Number
2645882|NCT01708161|Primary|Percentage of Patients With Overall Response Rate (RECIST) Based on Investigator Radiology Assessment for HR Positive Breast and Ovarian Cancer - Phase II|"The antitumor activity of alpelisib in combination with ganitumab in patients with PIK3CA mutated or amplified hormone receptor positive (HR+) breast (arm 1) or ovarian (arm 2) cancer.~Overall response rate is defined as the proportion of patients who have a best overall response of complete response or partial response assessed per RECIST 1.1."|Approximately 1 year (since initiation of Phase II, Dec 2013, till Primary CSR cut off 06Jan2015)|Full analysis set (FAS). The full analysis set (FAS) includes all patients who received at least one full or partial dose of alpelisib or ganitumab. Patients were analyzed according to the planned treatment combination.|||Percentages of participants||95% Confidence Interval|Number
2645883|NCT01708161|Primary|Dose Limiting Toxicities (DLTs) - Phase Ib|Phase lb only|28 days|Dose determining set (DDS): DDS includes all patients from the safety set who either met the minimum treatment exposure and safety evaluation requirements without experiencing DLT within Cycle 1 or experienced a DLT at any time during Cycle 1.|||Participants|||Number
2645884|NCT01708122|Secondary|O2 Saturation Post Drug Administration|After administration of the study drug, the subject is monitored (oxygen saturation), for any signs of respiratory depression or the presence of complications or side-effects including apnea or oxygen desaturation.|Baseline, 5 minutes 10 minutes and 30 minutes post drug-administration.||||percentage of O2 Saturation||Full Range|Mean
2645885|NCT01708122|Primary|Pre Procedure 0 - 10 Pain Numerical Rating Scale|"The NRS pain assessment (0 = no pain to 10 = worst possible pain) is recorded as outlined below:~1. baseline pain score at admission, when the subject checks in, 2 Upon entry of the cystoscope into the urethral meatus, 3. and thirty minutes after the cystoscopic procedure has been completed."|Pre procedure, During procedure, Post procedure||||0 - 10 Pain Numerical Rating Scale||Full Range|Median
2645886|NCT01708057|Secondary|PK Parameters (AZD8683)|Cmax, tmax, AUC|Pre-dose, 24hr post-dose|As the study was terminated prematurely none of the randomised patients have bean analysed.||||||
2645887|NCT01708057|Secondary|Maximum Increase in QTcF|maximum (post-dose values - baseline value) for each treatment visit.|baseline, 24hr post dose|As the study was terminated prematurely none of the randomised patients have bean analysed.||||||
2645888|NCT01708057|Secondary|Maximum Increase Heart Rate [HR]|Maximum (post-dose values - baseline value) for each treatment visit.|baseline, 24hr post dose|As the study was terminated prematurely none of the randomised patients have bean analysed.||||||
2645889|NCT01708057|Secondary|Maximum Increase in Diastolic Blood Pressure [DBP]|Maximum (post-dose values - baseline value) for each treatment visit.|The first 24 hours following dose administration|As the study was terminated prematurely none of the randomised patients have bean analysed.||||||
2645890|NCT01708057|Secondary|Maximum Increase in Systolic Blood Pressure [SBP]|Maximum (post-dose values - baseline value) for each treatment visit.|baseline, 24hr post dose|As the study was terminated prematurely none of the randomised patients have bean analysed.||||||
2645891|NCT01708057|Secondary|Average FEV1 as a Change From Baseline|Average FEV1 (0-24h): The average over 0 to 24 hours|The first 24 hours following dose administration|As the study was terminated prematurely none of the randomized patients have been analysed.||||||
2645892|NCT01708057|Primary|Change From Baseline in Trough FEV1 (22-26h)|The average over 22 to 26 hours, as change from baseline|22 to 26 hours following dose administration|As the study was terminated prematurely none of the randomized patients have been analysed.||||||
2645893|NCT01708057|Primary|Change From Baseline in Peak FEV1 (0-24h)|The maximum value over 24 hours post-dose, as change from baseline|The first 24 hours following dose administration|As the study was terminated prematurely none of the randomised patients have been analysed.||||||
2645972|NCT01707004|Secondary|Percentage of Participants With Platelet Recovery by Day 30|Platelet recovery is defined as the first day of a platelet count greater than 20,000/mm^3 with no platelet transfusions. Will be summarized with mean and standard deviation or median and interquartile range, and the change will be tested using a one-sample paired t-test at a two-tailed significance level of 0.05.|Up to day 30||||percentage with plt engraftment, day 30||95% Confidence Interval|Number
2645894|NCT01707992|Other Pre-specified|Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values|Potentially clinically significant hematological abnormalities included: Hemoglobin <=11.5, >=20 gm/dL in males, and <=10, >=18.5 gm/dL in females; WBCs count <=2.5 and >=21*10^9 per L; ANC <=1.49*10^9 per L; Platelet count <=100 and >=600*10^9 per L.|Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase|Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase.|||Participants|||Count of Participants
2645895|NCT01707992|Other Pre-specified|Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values|Potentially clinically significant hematological abnormalities included: Hemoglobin <=11.5 grams per deciliter (gm/dL) in males and <=10 gm/dL in females; White blood cells (WBCs) count <=2.5 and >=21*10^9 per liter (L); Absolute neutrophil count (ANC) <=1.49*10^9 per L; Platelet count <=100 and >=600*10^9 per L.|Baseline up to Month 24|Safety analysis set included all participants who were randomized and received at least one dose of study drug. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure.|||Participants|||Count of Participants
2645896|NCT01707992|Other Pre-specified|Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry|Potentially clinically significant serum chemistry abnormalities included: Glucose <=3 and >=13.88 mmol/L; ALT (in U/L), AST (in U/L), alkaline phosphatase (in U/L), GGT (in U/L), CPK (in U/L), CRP (in mg/L), pancreatic amylase (in U/L)>=3 * ULN; Fibrinogen >=6 gm/L; Sodium <=130 and >=150 mmol/L; Potassium <=3.2 and >=5.5 mmol/L; Calcium <=1.87 and >=2.75 mmol/L; Phosphate <=0.65 and >=1.61 mmol/L; Blood urea nitrogen (in mmol/L); Total bilirubin >=28 micromols per liter (micromols/L); Creatinine >=117 micromols/L; Albumin <=25 gm/L.|Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase|Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase.|||Participants|||Count of Participants
2645897|NCT01707992|Other Pre-specified|Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry|Potentially clinically significant serum chemistry abnormalities included: Glucose <=3 and >=13.88 millimoles per liter (mmol/L); Alanine aminotransferase (ALT) (in units per liter [U/L]), aspartate aminotransferase (AST) (in U/L), alkaline phosphatase (in U/L), gamma-glutamyltransferase (GGT) (in U/L), creatine phosphokinase (CPK) (in U/L), C-reactive protein (CRP) (in milligrams per liter [mg/L]), pancreatic amylase (in U/L)>=3 * upper limit of normal (ULN); Fibrinogen >=6 grams per liter (gm/L); Sodium <=130 and >=150 mmol/L; Potassium <=3.2 and >=5.5 mmol/L; Calcium <=1.87 and >=2.75 mmol/L; Phosphate <=0.65 and >=1.61 mmol/L.|Baseline up to Month 24|Safety analysis set included all participants who were randomized and received at least one dose of study drug. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure.|||Participants|||Count of Participants
2645898|NCT01707992|Other Pre-specified|Active Treatment Phase: Number of Participants With Shift From Baseline to Endpoint in ECG Parameters|ECG parameters included: PR interval, QRS interval, QTcF and QTcB. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.|Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase), endpoint (Month 24 of active-treatment phase)|Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase and had ECG shift from baseline data available.|||Participants|||Count of Participants
2645899|NCT01707992|Other Pre-specified|Placebo-Controlled Phase: Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters|ECG parameters included: PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.|Baseline, Endpoint (Month 24)|Safety analysis set included all participants who were randomized and received at least one dose of study drug. Here, 'Overall number of participants analyzed=participants evaluable for this outcome measure.|||Participants|||Count of Participants
2645900|NCT01707992|Other Pre-specified|Active-Treatment Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities|Clinically significant vital signs abnormalities included: Pulse rate: >=120 bpm and increase from baseline of >=30 bpm, <=45 bpm and decrease from baseline of >=30 bpm; Systolic blood pressure: >=180 mmHg and increase from baseline of >=30 mmHg, <=90 and decrease from baseline of >=30 mmHg; Diastolic blood pressure: >=100 mmHg and increase from baseline of >=20 mmHg, <=50 mmHg and decrease from baseline of >=20 mmHg.|Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase|Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase.|||Participants|||Count of Participants
2645901|NCT01707992|Other Pre-specified|Placebo-Controlled Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities|Clinically significant vital signs abnormalities included: Pulse rate: greater than or equal to (>=) 120 beats per minute (bpm) and increase from baseline of >=30 bpm, <=45 bpm and decrease from baseline of >=30 bpm; Systolic blood pressure: >=180 millimeters of mercury (mmHg) and increase from baseline of >=30 mmHg, <=90 and decrease from baseline of >=30 mmHg; Diastolic blood pressure: >=100 mmHg and increase from baseline of >=20 mmHg, <=50 mmHg and decrease from baseline of >=20 mmHg.|Baseline up to Week 24|Safety analysis set included all participants who were randomized and received at least one dose of study drug.|||Participants|||Count of Participants
2645913|NCT01707667|Secondary|Motility Index|Motility index (mmHg) was summarized for the following 3 time points: pre-dose, 0-5 hours post-dose, and 5-12 hours post-dose. The motility index is defined as the natural logarithm of all peak amplitudes of every contraction +1.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.|||mmHg||Standard Error|Least Squares Mean
2645902|NCT01707992|Other Pre-specified|Active-Treatment Phase: Number of Participants With AEs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.|Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase|Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase.|||Participants|||Count of Participants
2645903|NCT01707992|Other Pre-specified|Placebo-Controlled Phase: Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.|Baseline up to Month 24|Safety analysis set included all participants who were randomized and received at least one dose of study drug.|||Participants|||Count of Participants
2645904|NCT01707992|Secondary|Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months)|Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 9 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 9 months.|Baseline to Month 24|ITT analysis set included all randomized participants.|||Participants|||Count of Participants
2645905|NCT01707992|Secondary|Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months)|Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 6 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 6 months.|Baseline to Month 24|ITT analysis set included all randomized participants.|||Participants|||Count of Participants
2645906|NCT01707992|Secondary|Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse)|Relapse was defined as appearance of one or more new neurological abnormalities or reappearance or worsening of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in EDSS; or one grade in score of 2 or more of 7 Functional Systems (FS) (excluding changes in bowel or bladder function or cognition); or 2 grades in score of one of the FS as compared to previous evaluation. EDSS assesses disability in 8 FS with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of relapsing participants (number of participants with confirmed relapse).|Baseline to Month 24|ITT analysis set included all randomized participants.|||Participants|||Count of Participants
2645907|NCT01707992|Secondary|Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15|Brain atrophy was defined by the percent change in brain volume from baseline to Month 15. For participants who prematurely discontinued treatment or completed the placebo-controlled phase before Month 15, the last available measurement was used, provided it was performed at least 9 months following the initiation of study drug.|Baseline, Month 15|The modified intent-to-treat 1 (mITT1) analysis set included data from all randomized participants at the Month 15 visit. Here, 'Overall number of participants analyzed' = Participants evaluable for this outcome measure.|||percent change||Standard Deviation|Mean
2645908|NCT01707992|Primary|Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months)|Time to CDP was defined as the time to a sustained increase in Kurtzke's Expanded Disability Status Scale (EDSS) score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least three months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]). Data is presented as distribution of CDP (number of participants with CDP) sustained for 3 months.|Baseline to Month 24|ITT analysis set included all randomized participants.|||Participants|||Count of Participants
2645909|NCT01707693|Other Pre-specified|Stage of Change (SOC)|Exercise Stage of Change information on how ready an individual is to make a change related to participating in physical activity. It consists of four questions (Yes or No response format) in which the individual is rated on current stage of change|Baseline, 3 and 6 months|8 participants withdrew from the control group and 13 withdrew from the PA intervention at 3 months. At 6 months 5 participants withdrew from the control group and no withdrawals from the PA intervention group|||Participants|||Count of Participants
2645910|NCT01707693|Other Pre-specified|Self-Efficacy|"Self-Efficacy for Exercise Scale used to estimate the strength of self-efficacy beliefs; The tool contains 9 items with an 0-10 answer format from Not Confident to Very Confident and summed numerical ratings; higher scores indicate greater self-efficacy."|Baseline, 3mths, 6mths|8 participants withdrew from the control group and 13 withdrew from the PA intervention at 3 months. At 6 months 5 participants withdrew from the control group and no withdrawals from the PA intervention group|||mean score on a (0-10) scale||Standard Deviation|Mean
2645911|NCT01707693|Secondary|Step of Counts (Per Day)|Number of steps that a person takes per day|3 and 6 months|Attrition of 5 participants|||Steps per day||Inter-Quartile Range|Median
2645912|NCT01707693|Primary|Accelerometer Vector Magnitude Counts|motion data counts calculated from three axes|3 and 6 months|Number of participants with completed data|||Vector Magnitude Counts||Inter-Quartile Range|Median
2645914|NCT01707667|Secondary|Duration of HAPC|The mean duration of all HAPCs was calculated as the sum of the duration of each HAPC divided by the number of HAPCs.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.|||sec||Standard Error|Least Squares Mean
2645915|NCT01707667|Secondary|Propagation Velocity of HAPC|Propagation velocity was calculated as the extension divided by the duration for each HAPC. Mean propagation velocity is the sum of the propagation velocities divided by the number of HAPCs.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.|||cm/sec||Standard Error|Least Squares Mean
2645916|NCT01707667|Secondary|Time to First HAPC|The median (95% CI) time to first HAPC after administration of investigational product with amplitude ≥100mmHg and extension ≥20cm.|over 12 hours post-dose|The Pharmacodynamic Analysis Set included all subjects in the Safety Analysis Set who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.|||hours||95% Confidence Interval|Median
2645917|NCT01707667|Secondary|The Mean Amplitude of HAPC|The mean amplitude of all HAPCs was calculated as the sum of the mean amplitude for each HAPC divided by the number of HAPCs.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.|||mmHg||Standard Error|Least Squares Mean
2645918|NCT01707667|Secondary|Area Under the Concentration Curve (AUC) of All HAPCs|The AUC of all HAPCs during the first 12 hours after treatment was calculated as the sum of the AUC at all sensors of each HAPC at the ≥100mmHg and ≥20cm threshold.|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.|||mmHg.sec||Standard Error|Least Squares Mean
2645919|NCT01707667|Primary|The Number of High-Amplitude Propagating Contractions (HAPC)|Manometry recordings were read by an experienced gastroenterologist who was blinded to the treatment each subject received. The tracings were analyzed using computer-based validated software. HAPC and manometry data were available for every sensor as well as average values for each HAPC and manometry time point. The primary outcome analysis of HAPC data used the following threshold: Mean amplitude ≥100mmHg and extension ≥20cm (9 sensors).|over 12 hours post-dose|The Pharmacodynamic Analysis Set consisted of all randomized subjects who had taken at least 1 dose of investigational product and who had 1 evaluable manometry assessment (minimum of 4 hours of manometry recordings from the intake of investigational product) for each treatment period.|||Number of HAPC with amplitude ≥100mmHg||Standard Error|Least Squares Mean
2645920|NCT01707654|Other Pre-specified|Pain|Pain was given subjectively by the patient using the visual analogue scale (VAS). The VAS consists of a 10 cm line that was grouped into mild (1-3 cm), moderate (4-6 cm) and severe (7-10 cm).|17-25 months|||||||
2645921|NCT01707654|Secondary|Semmes-Weinstein (SW) Monofilament Test|The test points were at the center of the radial or ulnar portion of the pulp. The donor site, i.e. radial- or ulnar-dorsal aspect of the middle phalanx of the donor digit, was also evaluated.|17-25 months|||||||
2645922|NCT01707654|Primary|2-point Discrimination Test|The 2-point Discrimination Test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm. The test points were at the center of the radial or ulnar portion of the pulp. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4 mm as a limit of 2PD and considered this normal. The assessments were performed at a single time point at the final follow up.|17-25 months||||mm||Standard Deviation|Mean
2645923|NCT01707472|Secondary|Change From Baseline in Liver Fibrosis as Estimated by MRE at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.|||kPa||Standard Deviation|Mean
2645924|NCT01707472|Secondary|Change From Baseline in Alpha SMA at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with liver biopsy area ≥ 4 mm^2 (adequate for morphometry measurements) were analyzed.|||percentage of alpha-SMA||Standard Deviation|Mean
2645925|NCT01707472|Secondary|Change From Baseline in MQC at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with liver biopsy area ≥ 4 mm^2 (adequate for morphometry measurements) were analyzed.|||percentage of MQC||Standard Deviation|Mean
2645926|NCT01707472|Secondary|Change From Baseline in HVPG at Week 24||Baseline; Week 24|Participants in the Full Analysis Set were analyzed.|||mm Hg||Standard Deviation|Mean
2645927|NCT01707472|Secondary|Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24|The Ishak fibrosis score measures the degree of liver fibrosis (scarring) and ranges from 0 (best) to 6 (worst). A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Baseline; Week 24|Participants in the Full Analysis Set (who were enrolled into the study and received at least 1 dose of study drug) with available data were analyzed.|||Participants|||Count of Participants
2645928|NCT01707472|Primary|Percentage of Participants Experiencing Treatment-Emergent Adverse Events||First dose date up to Week 24 plus 30 days|The Safety Analysis Set included participants who received at least one dose of study drug.|||percentage of participants|||Number
2645929|NCT01707381|Secondary|IOP Area Under the Curve Over 24 Hours|The Area Under the Curve(AUC) is the weighted average of IOP over all 24-hour IOP assessment times (2pm, 4pm, 6pm, 8pm, 10pm, 12am, 2am, 4am, 6am, 8am, 10am, 12pm). The AUC was calculated using the trapezoidal rule.|after 4 weeks of treatment|ITT population|||mm Hg||Standard Deviation|Least Squares Mean
2645956|NCT01707095|Secondary|Histologic Evidence of Burn at the Epigastric Port Site Skin.|Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The secondary outcome is histologic evidence of burn at this port site.|1 day||||participants|||Number
2645930|NCT01707381|Secondary|24-hour Ocular Perfusion Pressure|Sitting Ocular Perfusion Pressure = 95/140 x mean arterial blood pressure - IOP; Supine Ocular Perfusion Pressure = 115/130 x mean arterial blood pressure - IOP; the nocturnal time frame encompassed measures taken at 10pm, 12am, 2am and 4 am; whereas the diurnal time frame encompassed measures taken at 6am, 8am, 10am, 12pm, 2pm, 4pm, 6pm, and 8pm.|after 4 weeks of treatment|Intent to Treat (ITT): All randomized subjects who received at least one dose of study drug, had a baseline, and at least one post baseline intraocular assessment.|||mm Hg||Standard Deviation|Mean
2645931|NCT01707381|Primary|24 Hour IOP|Supine intraocular pressure (IOP) measured in the study eye following 4 weeks of treatment|after 4 weeks of treatment|Intent to Treat (ITT) Population:All randomized subjects who received at least one dose of study drug, had a baseline and at least one postbaseline intraocular assessment.|||mm Hg||Standard Deviation|Least Squares Mean
2645932|NCT01707368|Secondary|Side Effects|Number of participants with serious and non-serious adverse drug reactions.|1 year|All enrolled|||Number of events recorded|||Number
2645933|NCT01707368|Secondary|PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)|"Assessment on 6-step scale from no visible disease (O) to very severe disease (5)"|1 year|Participants with at least one observation after baseline (last observation carried forward)|||Participants|||Count of Participants
2645934|NCT01707368|Secondary|PGA (Physician's Global Assessment of Psoriasis Vulgaris Severity)|6--point verbal rating scale|Baseline|Participants with at least one severity assessment after baseline|||Participants|||Count of Participants
2645935|NCT01707368|Primary|The Course of Disease and Relapse Management During Treatment With Daivobet® Gel Under Consideration of Patient`s Individual Application Habits Under Daily Use Conditions.|Number of exacerbations and relapses during one year observation time|1 year|Participants with at least one observation after baseline|||Participants|||Count of Participants
2645936|NCT01707290|Secondary|Number of Participants With Serious Adverse Events (SAEs) in Observational Arm|SAE was defined as a medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.|up to 2 years (Study 112)|Analysis population included all participants who were included in the observational arm.|||participants|||Number
2645937|NCT01707290|Secondary|Number of Pulmonary Exacerbations Events|Pulmonary exacerbation events include those events which require treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms. The number of events were reported. Results were planned to be reported for Ivacaftor arm and were stratified by parent study 110, 111 and 113.|Through Week 104 (Study 112)|FAS included all participants who received at least 1 dose of study drug (Ivacaftor).|||pulmonary exacerbation events|||Number
2645938|NCT01707290|Secondary|Absolute Change From Baseline in Respiratory Domain of the Cystic Fibrosis Questionnaire Revised (CFQ-R) at Week 2, 12, 24, 36, 48, 60, 72, 84, 96 and 104|The CFQ-R is a validated participant reported outcome measuring health related quality of life for participants with CF. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health related quality of life. Baseline was defined as the most recent measurement before intake of the first dose of study drug (ivacaftor) in Study 112. Results were planned to be reported for Ivacaftor arm and were stratified by parent study 110, 111 and 113.|Baseline, Week 2, 12, 24, 36, 48, 60, 72, 84, 96 and 104 (Study 112)|"FAS included all participants who received at least 1 dose of study drug (ivacaftor). Here, Number Analyzed signifies those participants who were evaluable for this measure at the specified time point for each arm respectively."|||units on a scale||Standard Deviation|Mean
2645939|NCT01707290|Secondary|Absolute Change From Baseline in Sweat Chloride at Week 2, 24, 48 and 104|Sweat samples were collected using an approved collection device. Baseline was defined as the most recent measurement before intake of the first dose of study drug (Ivacaftor) in Study 112. Results were planned to be reported for Ivacaftor arm and were stratified by parent study 110, 111 and 113.|Baseline, Week 2, 24, 48 and 104 (Study 112)|"FAS included all participants who received at least 1 dose of study drug (Ivacaftor). Here, Number of participants analyzed signifies those participants who were evaluable for this outcome and Number Analyzed signifies those participants who were evaluable for this measure at the specified time point for each arm respectively."|||millimole per liter (mmol/L)||Standard Deviation|Mean
2645940|NCT01707290|Secondary|Absolute Change From Baseline in Body Mass Index (BMI) at Week 2,12, 24, 36, 48, 60, 72, 84, 96 and 104|BMI was defined as weight in kg divided by height in m^2. Baseline was defined as the most recent measurement before intake of the first dose of study drug (Ivacaftor) in Study 112. Results were planned to be reported for Ivacaftor arm and were stratified by parent study 110, 111 and 113.|Baseline, Week 2, 12, 24, 36, 48, 60, 72, 84, 96 and 104 (Study 112)|"FAS included all participants who received at least 1 dose of study drug (Ivacaftor). Here, Number analyzed signifies those participants who were evaluable for this measure at the specified time point for each arm, respectively."|||kilogram per square meter (kg/m^2)||Standard Deviation|Mean
2645941|NCT01707290|Secondary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 12, 24, 36, 48, 60, 72, 84, 96, and 104|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 6 to 17 years and for female participants aged 6 to 15 years. Baseline was defined as the most recent measurement before intake of the first dose of study drug (Ivacaftor) in Study 112. Results were planned to be reported for Ivacaftor arm and were stratified by parent study 110, 111 and 113.|Baseline, Week 2, 12, 24, 36, 48, 60, 72, 84, 96 and 104 (Study 112)|"Full Analysis Set (FAS) included all participants who received at least 1 dose of study drug (Ivacaftor). Here, Number Analyzed signifies those participants who were evaluable for this measure at the specified time point for each arm, respectively."|||Percent predicted of FEV1||Standard Deviation|Mean
2645957|NCT01707095|Primary|Histologic Thermal Injury to Umbilical Port Site Skin|Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at these port sites.|1 day||||participants|||Number
2645942|NCT01707290|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) in Ivacaftor Arm|AE: any untoward medical occurrence in a participants during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, In-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. TEAEs were defined as adverse events with start date or increased severity on and after the first dose of study drug through Week 108.|Day 1 up to Week 108 (Study 112)|Safety Set included all participants who received at least 1 dose of study drug (Ivacaftor).|||participants|||Number
2645943|NCT01707238|Secondary|Satisfaction With Comfort|Participant's subjective rating for overall satisfaction of lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).|two weeks and four weeks from baseline visit||||percentage of participants|||Number
2645944|NCT01707238|Secondary|Satisfaction With Dryness|Participant's subjective rating for overall satisfaction of lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).|two weeks and four weeks from baseline visit||||percentage of participants|||Number
2645945|NCT01707238|Primary|Satisfaction With Handling|Participant's subjective rating for overall satisfaction of lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).|two weeks and four weeks from baseline visit||||percentage of participants|||Number
2645946|NCT01707238|Secondary|Dryness|Participant's subjective rating for overall lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=no dryness).|two weeks and four weeks from baseline visit||||units on a scale||Standard Deviation|Mean
2645947|NCT01707238|Secondary|Comfort|Participant's subjective rating for overall lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=can't feel).|two weeks and four weeks from baseline visit||||units on a scale||Standard Deviation|Mean
2645948|NCT01707238|Primary|Handling|Participant's subjective rating for lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10= very easy).|two weeks and four weeks from baseline visit||||units on a scale||Standard Deviation|Mean
2645949|NCT01707225|Secondary|Need for Blood Transfusion and Hospital Admission for GI Bleed||24 weeks||||participants||95% Confidence Interval|Number
2645950|NCT01707225|Primary|Number of Participants With Side-Effects|"Cardiovascular:~Sinus bradycardia (19% to 25%) Hypertension (≤13%) conduction abnormalities (9% to 10%)~Central nervous system:~Fatigue (1% to 32%) headache (6% to 30%) malaise (16% to 20%) fever (16% to 20%) dizziness (5% to 20%) Pain (4% to 15%)~Dermatologic:~Pruritus (≤18%) Rash (15%; depot formulation) alopecia (≤13%)~Endocrine & metabolic:~Hyperglycemia (2% to 27%)~Gastrointestinal:~Abdominal pain (5% to 61%) loose stools (5% to 61%) nausea (5% to 61%) diarrhea (34% to 58%) flatulence (≤38%) cholelithiasis (13% to 38%; length of therapy dependent) constipation (9% to 21%) vomiting (4% to 21%)~Hematologic Anemia (5-15%)~Local:~Injection site pain (2% to 50%; dose and formulation related)~Neuromuscular & skeletal:~Back pain (1% to 27%) arthropathy (8% to 19%) myalgia (≤18%)~Renal Kidney Stones (5-15%)~Respiratory:~Upper respiratory infection (10% to 23%)~Miscellaneous:~flu symptoms (1% to 20%)"|24 weeks||||participants||95% Confidence Interval|Number
2645951|NCT01707147|Secondary|Change From Baseline After 24 Weeks in Fasting Plasma Glucose (FPG)|Change from baseline after 24 weeks in fasting plasma glucose (FPG).|Baseline and Week 24|Effectiveness analysis set: the patients with the data available for FPG|||Milligrams per Deciliter||Standard Deviation|Mean
2645952|NCT01707147|Secondary|Percentage of Patients With Occurrence of Relative Effectiveness Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)|Percentage of patients with occurrence of relative effectiveness response (HbA1c lowering by at least 0.5% after 24 weeks of treatment).|24 Weeks|Effectiveness analysis set|||Percentage of patients|||Number
2645953|NCT01707147|Secondary|Percentage of Patients With Occurrence of Treat to Target Effectiveness Response, That is HbA1c Under Treatment of < 6.5% After 24 Weeks of Treatment|Percentage of patients with occurrence of treat to target effectiveness response, that is HbA1c under treatment of < 6.5% after 24 weeks of treatment.|24 Weeks|Effectiveness analysis set|||Percentage of patients|||Number
2645954|NCT01707147|Secondary|Change From Baseline After 24 Weeks in Glycosylated Hemoglobin (HbA1c)|Change from baseline after 24 weeks in Glycosylated Hemoglobin (HbA1c).|Baseline and Week 24|Effectiveness analysis set: This set includes all patients of the safety analysis set for whom HbA1c values were measured at both baseline and after drug administration.|||Percentage of HbA1c||Standard Deviation|Mean
2645955|NCT01707147|Primary|Percentage of Patients With Incidence of Adverse Events Who Had Taken at Least One Dose of Trajenta|Percentage of patients with incidence of any adverse events who had taken at least one dose of Trajenta.|Up to 26 weeks (long-term surveillance)|Safety analysis set: This analysis set included all patients who were administrated Trajenta at least once, except patients violating inclusion/exclusion criteria, dosage administration or lost to follow up.|||Percentage of patients|||Number
2645958|NCT01707043|Primary|Subjective Subject Preference Survey for the Second Treatment Session|Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105.|3 days||||units on a scale||Standard Deviation|Mean
2645959|NCT01707043|Primary|Subjective Subject Preference Survey for the First Treatment Session|Subjective Subject Preference Survey The Subjective Subject Preference Survey consist of 15 questions relating to patients preference of study drug. The survey includes questions such as how the medication feels to touch, how greasy it is, and time it takes to apply. The final question asks patients to rate the overall appeal of the vehicle. Questions are scored on a 7-point scale, where a score of 1 is extremely unpleasant, 4 is neutral, and a score of 7 is extremely appealing. Total preference score based on the Subjective Subject Preference Survey could range from 15-105.|3 days||||units on a scale||Standard Deviation|Mean
2645960|NCT01707030|Other Pre-specified|Change in SF-12 Mental Health Composite|The Short Form-12 (SF-12) is a 12-item health survey based on the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) designed to assess two component health status summary scales (physical and mental component summaries) in the general U.S. population. The SF-12 has demonstrated good internal consistency reliability and construct validity. This reflects the mental health component of the SF-12. Scores range from 0-100 and higher scores are better.|Baseline, 3 months, and 6 months|Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.|||score on a scale||Standard Deviation|Mean
2645961|NCT01707030|Secondary|Change in Additional Care|We will measure the degree to which Veteran participants seek additional substance use disorder (SUD) care over the course of the three- and six- month follow up periods. We will assess whether Veterans seek out outpatient/inpatient care of a substance abuse problem within or outside the VA system. We will also assess whether Veterans access self-help care outside the VA such as attending a meeting at Alcoholics Anonymous.|Baseline, 3 months, and 6 months||2020-02-29|02/2020||||
2645962|NCT01707030|Secondary|Change in SF-12 Physical Health Composite|The Short Form-12 (SF-12) is a 12-item health survey based on the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) designed to assess two component health status summary scales (physical and mental component summaries) in the general U.S. population . The SF-12 has demonstrated good internal consistency reliability and construct validity. This reflects the physical health component of the SF-12. Scores range from 0-100 and higher scores are better.|Baseline, 3 months, and 6 months|Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.|||score on a scale||Standard Deviation|Mean
2645963|NCT01707030|Secondary|Change in Symptoms of Psychological Distress (PHQ-9)|Symptoms of psychological distress will be measured using the Patient Health Questionnaire (PHQ-9). The PHQ-9 provides an assessment of depression severity. The minimum value is 0 and the maximum value is 27. Lower scores are better. The reliability, validity, and clinical utility of the PHQ-9 instrument are well-established.|Baseline, 3 months, and 6 months|Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.|||score on a scale||Standard Deviation|Mean
2645964|NCT01707030|Secondary|Change in Drinks Per Drinking Day|The number of standard drinks (0.5 ounce ethanol equivalent) consumed on those days that an individual drank in the last 30 days.|Baseline, 3 months, and 6 months|Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.|||Drinks per Drinking Day||Standard Deviation|Mean
2645965|NCT01707030|Primary|Change in Drinking Days|The number of days on which alcohol was consumed at any level in the last 30 days.|Baseline, 3 months, and 6 months|Not all participants were able to complete all questions and/or follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.|||Number of drinking days in last 30||Standard Deviation|Mean
2645966|NCT01707030|Primary|Change in Days of Unhealthy Alcohol Consumption|The number of days on which alcohol was consumed beyond recommended levels in the last 30 days.|Baseline, 3 months, and 6 months|Not all participants were able to complete all follow-ups in their entirety. We used an analytical approach that used all available data for the participants for the regression analysis even if participants did not complete all the follow-ups.|||Unhealthy drinking days in last 30||Standard Deviation|Mean
2645967|NCT01707004|Secondary|Progression Free Survival||Up to 1 year||||days||95% Confidence Interval|Median
2645968|NCT01707004|Secondary|Number of Participants With Complete Remission After Transplantation||Up to 1 year||||Participants|||Count of Participants
2645969|NCT01707004|Secondary|Cumulative Incidence of Chronic GVHD According to BMTCTN|Will be summarized with a proportion and a 95% confidence interval.|Up to 1 year||||percentage||95% Confidence Interval|Number
2645970|NCT01707004|Secondary|Cumulative Incidence of Grade III-IV Acute GVHD|Determined by the standard bone marrow transplant (BMT) Clinical Trials Network criteria (BMTCTN). Will be analyzed using KM method, a Graft versus Host Disease (GVHD) grade III-IV will be obtained from the KM estimates along with 95% confidence intervals.|Day 100||||percentage of participants||95% Confidence Interval|Number
2645971|NCT01707004|Secondary|Number of Participants With Primary Graft Failure|Defined as less than 5% donor chimerism in the cluster of differentiation (CD)3 and CD33 selected cell populations at any time after transplantation. Will be analyzed using KM method.|Day 30||||Participants|||Count of Participants
2646252|NCT01704976|Secondary|Isometric Maximum Voluntary Contraction (IMCV) in Newton (N) Right Knee-extensor|It will be evaluated by isometric MCV (Newton) at 90 degree angle in the knee joint.|after 4 weeks||||Newton||Inter-Quartile Range|Median
2645973|NCT01707004|Secondary|Time to Neutrophil Recovery|Defined as achieving an absolute neutrophil count (ANC) greater than or equal to 500/ul for three consecutive measurements on different days. Will be summarized with mean and standard deviation or median and interquartile range, and the change will be tested using a one-sample paired t-test at a two-tailed significance level of 0.05.|Up to 1 year||||days||95% Confidence Interval|Mean
2645974|NCT01707004|Primary|Overall Survival (OS)|Will be analyzed using Kaplan-Meier (KM) method, and OS will be obtained from the KM estimates along with 95% confidence intervals.|Day 100|(2 patients did not receive a transplant due to infectious complications, 1 patient received transplant off protocol)|||percentage of participants||95% Confidence Interval|Number
2645975|NCT01706965|Primary|Final MATRICS Cognitive Battery|MATRICS assessing 7 domains (Speed of Processing, Attention/Vigilance, Working Memory, Verbal Learning, Visual Learning, Reasoning and Problem Solving, and Social Cognition. Raw scores are converted into a composite T-score (normative mean = 50; standard deviation = 10), where higher values indicated less impairment.|Baseline to week 6||||Total MATRICS score||Standard Deviation|Mean
2645976|NCT01706965|Primary|Final Positive and Negative Symptom Scale (PANSS)|This is a is a 30 item rating scale widely used in the assessment of schizophrenia ranging from 30-210. Higher scores are worse|Baseline (start of Kuvan) and at six weeks of treatment||||PANSS Total||Standard Deviation|Mean
2645977|NCT01706952|Secondary|End Tidal CO2|"The concentration of carbon dioxide (CO2) in the respiratory gases will be recorded every 15 minutes or until 300 minutes.~For the secondary objective of concentration of carbon dioxide, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference"|Every 15 minutes or until 300 minutes||||Percentage of carbon dioxide||Standard Deviation|Mean
2645978|NCT01706952|Secondary|Blood Pressure|"The mean blood pressure, defined as the average arterial pressure during a single cardiac cycle, will be recorded every 15 minutes, until the surgery is over or until 300 minutes.~For the secondary objective of blood pressure, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference"|Every 15 minutes or until 300 minutes||||mmHg||Standard Deviation|Mean
2645979|NCT01706952|Secondary|Heart Rate|"The heart rate (heart beats for minutes) will be recorded every 15 minutes, until the surgery is over or until 300 minutes.~The Co-investigator will record this data in a special data sheeet For the secondary objective of Heart rate, we calculated the average within sides treated with cocaine vs adrenaline and assessed its difference"|Every 15 minutes until 300 minutes||||Heart Beats per minute||Standard Deviation|Mean
2645980|NCT01706952|Primary|To Estimate the Change in Bleeding Category (Surgical Field Improvement) as Measured on a Six-point Scale, Measured From 0 (Best Case) to 5 (Worst Case).|"0 No bleeding.~Slight bleeding - no suctioning of blood required.~Slight bleeding - occasional suctioning required. Surgical field not threatened.~Slight bleeding - frequent suctioning required. Bleeding threatens surgical field a few seconds after suction is removed.~Moderate bleeding - frequent suctioning required. Bleeding threatens surgical field directly after suction is removed.~Severe bleeding - constant suctioning required. Bleeding appears faster than can be removed by suction. Surgical field severely threatened and surgery not possible.~For the primary objective of surgical field grade, we calculated the mean within sides treated with cocaine vs adrenaline and assessed its difference"|Every 15 minutes until 300 minutes|EACH SIDE WAS EVALUATED SEPARATELY|||units on a scale||Standard Deviation|Mean
2645981|NCT01706926|Secondary|Percentage of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit|Immunogenicity assessment included determination of anti-drug (mavrilimumab) antibodies in serum samples. ADA detection measured by using electrochemiluminescence assays.|Day 1 to Day 169|The immunogenicity population included all participants who received at least 1 dose of mavrilimumab and for whom at least one serum sample for immunogenicity testing was available.|||percentage of participants|||Number
2645982|NCT01706926|Secondary|Serum Concentrations of Mavrilimumab|Serum concentrations after multiple subcutaneous doses of mavrilimumab were calculated for each cohort (30mg, 100mg and 150mg). Geometric coefficient of variation at Baseline for cohorts 30mg and 150mg were calculated as the negligible mean value was observed.|Baseline, Day 8, 15, 29, 85, 141, and 169|"The pharmacokinetic (PK) population included all participants who received mavrilimumab and for whom serum concentrations of mavrilimumab were available for PK data analyses. Here n signifies participants who were evaluable for the specified time point for each arm, respectively."|||nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2645983|NCT01706926|Secondary|Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-fatigue) at Day 169|FACIT-F is a 13-item questionnaire questionnaire to measure the degree of fatigue experiences by participants in the previous 7 days. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score) where higher sore represent less fatigue.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
2645984|NCT01706926|Secondary|Percentage of Participants With American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission at Day 169|ACR/EULAR remission was defined as swollen joint count (0-66), tender joint count (0-68), CRP (mg/dL) and participant global assessment (0-10) all less than or equal to one.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
2645985|NCT01706926|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Day 169|The CDAI was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS. The CDAI total score ranges from 0 to 76 where higher scores indicates greater affection due to disease activity. CDAI remission was defined as a score less than or equal to 2.8.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
2645986|NCT01706926|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Day 169|The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient global assessment and physician global assessment assessed on 0 - 10 cm VAS; and C-reactive protein (CRP) (milligram per deciliter [mg/dL]). The SDAI total score ranges from 0 to 86, where higher scores indicates greater affection due to disease activity. SDAI remission was defined as a score less than or equal to 3.3.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
2645987|NCT01706926|Secondary|Ratio of Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Day 169|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. The farther the red blood cells have descended, the greater the inflammatory response.|Baseline, Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (Number of participants analyzed) signifies those participants who were evaluable for this measure."|||ratio||Geometric Coefficient of Variation|Geometric Mean
2645988|NCT01706926|Secondary|Ratio of Change From Baseline in C-Reactive Protein (CRP) at Day 169|CRP is a substance produced by the liver that increases in the presence of inflammation in the body. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in underlying disease.|Baseline, Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (Number of participants analyzed) signifies those participants who were evaluable for this measure."|||ratio||Geometric Coefficient of Variation|Geometric Mean
2645989|NCT01706926|Secondary|Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Day 169|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
2645990|NCT01706926|Secondary|Mean Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Day 169|Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 10 centimeter (cm) VAS, where 0 cm = very good and 10 cm = very bad.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||cm||Standard Error|Mean
2645991|NCT01706926|Secondary|Mean Change From Baseline in Patient Global Assessment (PGA) of Disease Activity at Day 169|"Participants responded to a question, Considering all the ways your arthritis affects you, how are you feeling today? by using a 0 - 100 millimeter (mm) VAS, where 0 = very well and 100 = very poorly."|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||mm||Standard Error|Mean
2645992|NCT01706926|Secondary|Mean Change From Baseline in Patient Assessment of Pain at Day 169|Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||mm||Standard Error|Mean
2645993|NCT01706926|Secondary|Mean Change From Baseline in Swollen and Tender Joint Count at Day 169|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1. Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1.|Baseline and Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||joint count||Standard Error|Mean
2645994|NCT01706926|Secondary|Percentage of Participants With DAS28 (CRP) Remission and Low Disease Activity at Day 169|DAS28 (CRP) calculated SJC and TJC using the 28 joints, GH using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (mg/L). Total score range: 0-9.4, higher score= more disease activity. Remission was defined as less than 2.6 DAS28 (CRP) score. Low disease activity was defined as less than 3.2 DAS28 (CRP) score.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
2645995|NCT01706926|Secondary|Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 169|DAS28 (CRP) response by EULAR category were used to measure individual response as none, moderate, and good, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline >1.2 with baseline DAS28 (CRP) <3.2; moderate response: change from baseline >1.2 with baseline DAS28 (CRP) >=3.2 to less than or equal to (=<) 5.1 or change from baseline >=0.6 to =< 1.2 with baseline DAS28 (CRP) >=3.2 to =<5.1; no response: change from baseline <0.6 or change from baseline >=0.6 and =<1.2 with baseline DAS28 (CRP) >5.1.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
2645996|NCT01706926|Secondary|Change From Baseline in Continuous American College of Rheumatology (ACRn) Score at Day 169|ACR score - continuous (ACRn) was defined as the minimum of the percentage improvement in TJC, SJC and the median of the percentage improvements in the other five components of the ACR criteria (participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; disability index of the HAQ; and CRP). Total score range was -100 to 100, where negative numbers indicated worsening and positive numbers indicated improvement.|Baseline up to Day 169|"The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||units on a scale||Standard Error|Mean
2645997|NCT01706926|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169|ACR70 was defined as >=70% improvement, in: SJC and TJC and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
2645998|NCT01706926|Secondary|Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169|ACR50 was defined as >=50% improvement, in: SJC and TJC and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
2645999|NCT01706926|Secondary|Oxygen Saturation Level at Day 169|Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.|Day 169|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||percent saturation||Standard Deviation|Mean
2646000|NCT01706926|Secondary|Dyspnea Score at Day 169|Borg dyspnea scale is a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicate greater difficulty in breathing.|Day 169|"The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||units on a scale||Standard Deviation|Mean
2646001|NCT01706926|Secondary|Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169|Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), and forced vital capacity (FVC). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as less than or equal to (=<) 15 percent (%), more than (>) 15 to =<20%, and >20%.|Day 169|"The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified threshold value mentioned parameter for each arm, respectively."|||percent of pulmonary test values|||Number
2646002|NCT01706926|Secondary|Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported.|Baseline up to Day 169|The safety population included all participants who received any dose of investigational product.|||participants|||Number
2646003|NCT01706926|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs)|Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (haemoglobin, absolute neutrophil count, leukocyte count, platelet count), serum chemistry (alanine transaminase, aspartate transaminase, bilirubin, gamma-glutamyl transferase), other serum chemistry (low-density lipoprotein cholesterol, triglycerides), and urinalysis.|Baseline up to Day 169|The safety population included all participants who received any dose of investigational product.|||participants|||Number
2646004|NCT01706926|Secondary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Day 169|The safety population included all participants who received any dose of investigational product.|||percentage of participants|||Number
2646005|NCT01706926|Primary|Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169|ACR20 was defined as >=20 percent (%) improvement, in: SJC and TJC and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.|Day 169|The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group.|||percentage of participants|||Number
2646029|NCT01706588|Primary|Area Under the Curve (AUC) of the Pain Scores.|Pain will be scored by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).|Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery||||mm*minutes||Standard Deviation|Mean
2646006|NCT01706926|Primary|Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85|DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per liter [mg/L]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (<) 3.2 = low disease activity, greater than or equal to (>=) 3.2 to 5.1 = moderate to high disease activity and <2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85.|Baseline and Day 85|"The modified intent-to-treat (mITT) population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
2646007|NCT01706822|Secondary|Maneuverability Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree|3. Maneuverability measured by surgeon usability questionnaire Question: Maneuverability of Radial reload during the procedure was adequate|Operatively||||% of cases surgeon agree/strongly agree|||Number
2646008|NCT01706822|Secondary|Visibility Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree|2. Visibility measured by surgeon usability questionnaire|Operatively||||% of cases surgeon agree/strongly agree|||Number
2646009|NCT01706822|Secondary|Access Measured by Surgeon Usability Questionnaire. The Reported Values Represent Percentage of Cases Surgeon Agree/Strongly Agree|1. Access measured by surgeon usability questionnaire.|Operatively||||% of cases surgeon agree/strongly agree|||Number
2646010|NCT01706822|Primary|The Ability to Achieve Adequate Distal Margins (Defined as >2cm [or >1cm With Clear Histologic Evaluation]) in the Low Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met|The ability to achieve adequate distal margins (defined as >2cm [or >1cm with clear histologic evaluation]) in the low rectum.|Operative||||participants|||Number
2646011|NCT01706822|Primary|The Surgeon's Ability to Achieve a Staple Line at the Desired Level of the Rectum. The Reported Value Represents the Number of Participants in Whom the Criteria Was Met|The surgeon's ability to achieve a staple line at the desired level of the rectum.|Operative||||participants|||Number
2646012|NCT01706770|Primary|Comparison of Objective Findings - Number of Adverse Events in Unique Eyes|"The primary safety endpoint are the objective findings of the number of adverse events in unique eyes associated with the enfilcon A contact lenses compared with those same findings as associated with the galyfilcon A contact lenses.~The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence from Baseline through end of month 1 visit."|Any occurrence from baseline to 1 month visit|Unique eyes are defined as each individual eye in the study.|||number of adverse events|Participants||Number
2646013|NCT01706770|Primary|Objective Assessment: Ocular Response - Biomicroscopy|"The primary safety endpoint are the objective slit lamp findings associated with the enfilcon A contact lenses compared with those same findings reported as associated with the galyfilcon A contact lenses.~The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline/Dispensing (baseline and dispensing visit combined), Post-Dispensing (after lenses were dispensed and allowed to settle) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit combined). The average grade for unique eyes with findings greater than 0 (none) is compared."|Change from baseline/dispensing visits, post-dispensing visit and all follow-ups visits|Unique eyes are defined as each individual eye in the study and are only counted once for each of the visit groupings.|||units on a scale|Participants|Full Range|Mean
2646014|NCT01706666|Secondary|Progression-free Survival|The distribution of progression-free survival will be estimated by arm using the method of Kaplan-Meier.|From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 3 years||||Months to Progression|||Number
2646015|NCT01706666|Secondary|Survival Time|The distribution of survival time will be estimated by arm using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 3 years|All patients are still alive|||Months to death|||Number
2646016|NCT01706666|Primary|Proportion of Patients Experiencing a Stringent Complete Response (sCR) After 12 Cycles, 24 Months|Estimated by the number of sCRs divided by the total number of evaluable patients in each arm. Exact binomial confidence intervals for the true sCR rate will be calculated by arm. Stringent complete response (sCR) is defined as a complete response plus normal serum free light chain ratio and the absence of clonal cells in bone marrow by flow cytometry.|24 months||||percentage of participants|||Number
2646017|NCT01706588|Secondary|Number of Patients With Adverse Events||from signature of the informed consent to 1 week postsurgery|||||||
2646018|NCT01706588|Secondary|Vital Signs||presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.|||||||
2646019|NCT01706588|Secondary|Recurrent Bleeding||every hour up to 6 hour postsurgery|||||||
2646020|NCT01706588|Secondary|Wound Healing||at 6 hour postsurgery, and on day 3 and 1 week postsurgery|||||||
2646021|NCT01706588|Secondary|Time to Onset of Pain||measured from end of surgery up to 12 hours postsurgery|||||||
2646022|NCT01706588|Secondary|Patient and Investigator Global Evaluation of the Effectiveness of Treatment||at 6 hour postsurgery and on Day 3|||||||
2646023|NCT01706588|Secondary|Rescue Medication Consumption||consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery|||||||
2646024|NCT01706588|Secondary|Amount of Rescue Medication||consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery|||||||
2646025|NCT01706588|Secondary|Time to First Use of Rescue Medication.||measured from end of surgery up to 1 week postsurgery|||||||
2646026|NCT01706588|Secondary|Peak Pain Intensity||measured from end of surgery up to 12 hours postsurgery|||||||
2646027|NCT01706588|Secondary|Trismus||measured at 6 hours postsurgery, at day 3 and 1 week postsurgery|||||||
2646028|NCT01706588|Secondary|Postsurgical Extra-oral Swelling||measured at 6 hours postsurgery, at day 3 and 1 week postsurgery|||||||
2646030|NCT01706575|Secondary|Safety: Percentage of Participants With Adverse Events (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline up to Week 48|Safety population included all participants who received least one dose of the study drug and had at least one post-dose safety assessment.|||percentage of participants|||Number
2646031|NCT01706575|Secondary|Efficacy: HBsAg Levels According to Interferon-Inducible Protein 10 (IP-10) Serum Levels||Baseline and Week 48|Data were not collected, and the outcome measure was not analyzed.||||||
2646032|NCT01706575|Secondary|Efficacy: HBsAg Levels According to Interleukin 28B (IL28B) Genotypes||Baseline and Week 48|Data were not collected, and the outcome measure was not analyzed.||||||
2646033|NCT01706575|Secondary|Efficacy: Number of Participants With Serum HBsAg Loss at Week 12 That Persisted up to Week 96|HBsAg loss is defined as HBsAg less than or equal to (</=) 0.05 IU/ml.|Week 12 up to Week 96|PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations.|||participants|||Number
2646034|NCT01706575|Secondary|Efficacy: Percentage of Participants With HBsAg Decrease >/=1 log10 IU/ml From Baseline to Week 48||Baseline, Week 48|PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations and who were undergoing the Week 48 visit.|||percentage of participants|||Number
2646035|NCT01706575|Secondary|Efficacy: Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at Week 24, 72 and 96|Change is calculated by HBsAg titer at baseline - HBsAg titer at week of assessments.|Baseline, Week 24, 72 and 96|PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations. Here, number of participants analyzed signifies those participants who were evaluable for the outcome measure and n signifies the number of participants who were evaluated at specified time points.|||international units per millilitre||Standard Deviation|Mean
2646036|NCT01706575|Primary|Efficacy: Percentage of Participants With Serum Hepatitis B Surface Antigen (HBsAg) Decrease >/= 50% From Baseline at End of the Combination Treatment (Week 48)|Participants who stopped pegylated interferon (PEG-IFN) treatment during the add-on phase due to serum HBsAg loss and HBsAg seroconversion were considered as responders.|Baseline and Week 48|PP included all participants without severe protocol violations, including major inclusion or exclusion criteria violations and who were undergoing the Week 48 visit.|||percentage of participants|||Number
2646037|NCT01706575|Primary|Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48)||Baseline up to Week 48|Per-Protocol Population (PP) included all participants without severe protocol violations, including major inclusion or exclusion criteria violations.|||percent change||Standard Deviation|Mean
2646038|NCT01706549|Secondary|Is the Pain Due to Hysterectomy?|Number of patients having posthysterectomy pain versus other pain|1-3 years||||participants|||Number
2646039|NCT01706549|Secondary|Quality of Life After Hysterectomy|Quality of life as measured by the SF-36, which consists of 8 scales.|1-3 years after hysterectomy|||||||
2646040|NCT01706549|Primary|Type of Chronic Pain After Hysterectomy|Number of participants with probable neuropathic, possible neuropathic, pain had subsided and other type of pain.|1-3 years after hysterectomy|Women undergone hysterectomy previously and reported having pain at the site of surgery six months after surgery|||participants|||Number
2646041|NCT01706536|Secondary|The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation|Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.|Baseline up to Day 28|The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.|||percentage of participants|||Number
2646042|NCT01706536|Secondary|The Percentage of Subjects With Treatment-emergent Serious Adverse Events|Treatment-emergent serious adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.|Baseline up to Day 28|The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.|||percentage of participants|||Number
2646043|NCT01706536|Secondary|The Percentage of Subjects With Treatment-emergent Adverse Events|Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.|Baseline up to Day 28|The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.|||percentage of participants|||Number
2646044|NCT01706536|Secondary|The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation|Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.|Baseline up to Day 28|The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.|||participants|||Number
2646045|NCT01706536|Secondary|The Number of Subjects With Treatment-emergent Serious Adverse Events|Treatment-emergent serious adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.|Baseline up to Day 28|The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.|||participants|||Number
2646046|NCT01706536|Secondary|The Number of Subjects With Treatment-emergent Adverse Events|Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.|Baseline up to Day 28|The safety population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication. Safety analyses were performed using the actual drug a subject received.|||participants|||Number
2646121|NCT01706146|Primary|Number of Days on Anticoagulation|Assess subject anticoagulant utilization and number of days on anticoagulation|up to 12 months||||days||Standard Deviation|Mean
2646047|NCT01706536|Secondary|The Peak FEV1 Change From Baseline|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Peak FEV1 is defined as the highest postdose FEV1 value within 4 hrs after the morning dose.|Day 28|The ITT population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication.|||liters||Standard Deviation|Mean
2646048|NCT01706536|Secondary|The Standardized Change From Baseline FEV1 AUC(12-24)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.|Day 28|A substudy of subjects in the ITT population consisted of subjects who were randomized to treatment and received at least 1 dose of double-blind study medication and who had extended spirometry measurements.|||liters||Standard Deviation|Mean
2646049|NCT01706536|Secondary|The Standardized Change From Baseline FEV1 AUC(0-12)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.|Day 28|The ITT population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication.|||liters||Standard Deviation|Mean
2646050|NCT01706536|Primary|Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the mean of the spirometry values collected at 23 hours 30 minutes and 24 hours after the in-clinic morning dose (i.e. approximately 12 hrs after the previous evening dose).|Baseline and Day 29|The ITT population consisted of all subjects who were randomized to treatment and received at least 1 dose of double-blind study medication.|||liters||Standard Deviation|Mean
2646051|NCT01706497|Secondary|Hospital Mortality|participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks|Hospital discharge||||Participants|||Count of Participants
2646052|NCT01706497|Secondary|Duration of Mechanical Ventilation|participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks|ICU discharge||||hours||Inter-Quartile Range|Median
2646053|NCT01706497|Secondary|Intensive Care Unit Length of Stay|participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks|Intensive care unit discharge||||days||Inter-Quartile Range|Median
2646054|NCT01706497|Secondary|Hospital Length of Stay|participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks|Hospital discharge||||days||Inter-Quartile Range|Median
2646055|NCT01706497|Primary|The Accuracy to Predict Acute Kidney Injury (AKI) Per Patient, 6 Hours Before This Clinical Event (AKI) Occurs|"Defined according to the Kidney Disease: Improving Global Outcome criteria (AKI stage 2 or 3)~serum creatinine (SCr) level ≥ 2 times the baseline level, or~urine output (UO) < 0.5 ml/kg/hour for ≥ 12 hours, or~provision of dialysis"|Predictive window of 6 hours before AKI occurence|"Of the 177 patients included, 21 patients were excluded:~4 had AKI within 6 hours after admission~16 were monitored with NIRS after AKI onset~NIRS monitoring was initiated later than 72 hours in 1 patient, which prevented the fit of prediction time for this patient"|||Participants|||Count of Participants
2646056|NCT01706458|Other Pre-specified|The Detection of Antigen Spread to Other Prostate Associated Antigens, and the Identification of Specific Antigens Recognized, Will be Analyzed Descriptively.|Not performed because no progression free survival at one year.|12 months|This outcome measure was not determined because there was no progression free survival at one-year.||||||
2646057|NCT01706458|Other Pre-specified|Logistic Regression Analysis Will be Conducted to Evaluate Whether Baseline Immune Responses Predict for Immune Responses Elicited/Augmented Following Treatment With Sipuleucel-T +/- DNA Vaccine.|Not performed because no progression free survival at one year.|12 months|This outcome measure was not determined because there was no progression-free survival at one-year.||||||
2646058|NCT01706458|Other Pre-specified|Logistic Regression Analysis Will be Conducted to Evaluate Whether PAP-specific Immune Response is Associated With Prolonged (1-year) Progression-free Survival.|Not performed because no progression free survival at one year.|12 months|This outcome measure was not determined because there was no progression free survival at one-year.||||||
2646059|NCT01706458|Other Pre-specified|PAP-specific Antibody and T-cell Immune Responses Following Treatment With Sipuleucel-T and DNA Vaccine|A response resulting from immunization was defined as a PAP-specific response detectable more than once post-treatment that was both significant (compared to media only control), at least 3-fold higher than the pre-treatment value, and with a frequency> 1:100,000 PBMC. An antibody response was defined as any increase in titer over baseline.|12 months||||Participants|||Count of Participants
2646060|NCT01706458|Other Pre-specified|Number of Circulating Tumor Cells||6 months|This outcome measure was not determined because there was no progression free survival at one-year.||||||
2646061|NCT01706458|Other Pre-specified|Overall Survival|Overall survival is defined as the time interval from randomization to death from any cause or to the last follow-up in censored patients.|5 years|||||||
2646062|NCT01706458|Secondary|Measure Prostate-specific Antigen (PSA) Doubling Time|"PSA doubling times were calculated from PSA values obtained up to 6 months from day 1 of study treatment. An increase in the PSA doubling time to at least double the baseline value will be defined as a PSA doubling time response."|12 months||||months||95% Confidence Interval|Median
2646063|NCT01706458|Secondary|Time to Radiographic Disease Progression|Time to radiographic progression using staging obtained at month 3 as baseline for evaluation.|12 months||||days||Full Range|Median
2646064|NCT01706458|Secondary|Progression-free Survival|Percentage of patients without radiographic progression at 12 months.|12 months||||Participants|||Count of Participants
2646065|NCT01706458|Primary|Number of Participants With Immune Response Following Treatment|The primary immunological goal of this study was to determine whether booster immunizations with a DNA vaccine encoding PAP could augment the number of PAP-specific effector and memory T cells following treatment with sipuleucel-T, or prolong the duration of detectable T-cell response. All subjects received a tetanus booster immunization prior to beginning the immunization series, providing a separate test of an individual's immune responsiveness. Responses to PSA, a non-target prostate specific protein, were concurrently evaluated, as were responses to GM-CSF, a component of the PA2024 fusion protein used in the preparation of sipuleucel-T.Samples were evaluated for antigen-specific IFNy or granzyme B secretion by ELISPOT, and the detection of statistically significant antigen-specific responses, that were at least 3-fold over the baseline value, and detectable more than once post-treatment, were used to define immune response to a particular antigen.|12 months||||Participants|||Count of Participants
2646066|NCT01706328|Secondary|Change From Baseline in Trough FEV1 on Treatment Day 85|FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the 24-hour FEV1 assessment, which was obtained on Day 85. Baseline trough was calculated as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 85 values minus the Baseline value. The analysis used an analysis of covariance (ANCOVA) model with covariates of Baseline FEV1, reversibility stratum, smoking status (at Screening), country, and treatment.|Baseline and Day 85|ITT Population. Only those participants available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
2646067|NCT01706328|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1 during the 0- to 4-hour serial measurements (5, 15, 30, 60, 120, and 240 minutes post-dose). Participants who never met or exceeded a 100 mL increase over the Baseline value during the 4-hour serial measurements were censored at the actual time of their last FEV1 measurement.|Baseline and Day 1|ITT Population. Only those participants available at the indicated time point were assessed.|||Minutes||Full Range|Median
2646068|NCT01706328|Primary|Change From Baseline Trough in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) on Treatment Day 84|FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 and the post-dose FEV1 measurements taken at 5, 15, 30, and 60 minutes and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was calculated as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. The weighted mean was derived by calculating the area under curve, and then dividing by the relevant time interval. The weighted mean change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measurements on Day 84 minus the Baseline trough FEV1 value. The analysis used an analysis of covariance (ANCOVA) model with covariates of Baseline FEV1, reversibility stratum, smoking status (at Screening), country, and treatment.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study drug. Only those participants available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
2646069|NCT01706263|Secondary|Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8|Redness, dryness, burning, itching and scaling were evaluated independently by the participant on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .|Baseline (Day 1) and Week 1, 2, 4, 8|Intent-to-treat analysis set.|||Score on scale||Standard Deviation|Mean
2646070|NCT01706263|Secondary|Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8.|Erythema , dryness, and peeling, were evaluated independently by the investigator on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .|Baseline (Day 1) and Week 1, 2, 4, 8|Intent-to-treat analysis set.|||Score on scale||Standard Deviation|Mean
2646071|NCT01706263|Secondary|Percentage of Participants Who Improved by at Least One Grade on the ISGA|Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Percent change from Baseline to specified time point was calculated as the value at specified time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .|Up to Week 8|Intent-to-treat analysis set.|||Percentage of participants|||Number
2646072|NCT01706263|Secondary|Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Weeks 1, 2, 4 and 8|Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value .|Baseline (Day 1) and Week 1, 2, 4, 8|Intent-to-treat analysis set.|||Score on a scale||Standard Deviation|Mean
2646073|NCT01706263|Secondary|Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4|Evaluator assessed the left side and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) and total lesions for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts was calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to specified time (Weeks 1, 2, and 4) point was calculated as the value at specified time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .|Baseline (Day 1) and Week 1, 2, 4|Intent-to-treat analysis set.|||Percent change||Standard Deviation|Mean
2646074|NCT01706263|Primary|Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Week 8|Evaluator assessed the left and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open [blackheads] and closed [whiteheads] comedones) and total lesions (sum of inflammatory and non-inflammatory lesion) for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 8 was calculated as the value at Week 8 minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value .|Baseline (Day 1) and Week 8|Intent-to-treat analysis set was used which included data from all randomized participants who received study product.|||Percent change||Standard Deviation|Mean
2646122|NCT01706081|Secondary|Number of Participants Evaluated for Adverse Events||1. 5 years||||Participants|||Count of Participants
2646075|NCT01706250|Secondary|Mean Change in Each of the Participant Assessments of Tolerability-Scaling|This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for scaling. The area on the face was assessed excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the scaling was graded on 0 to 5 scale based on severity by the participant; 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).|||units on scale||Standard Deviation|Mean
2646076|NCT01706250|Secondary|Mean Change in Each of the Participant Assessments of Tolerability-Itching|This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for itching. The area on the face was assessed excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the itching was graded on 0 to 5 scale based on severity by the participant; 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).|||units on scale||Standard Deviation|Mean
2646077|NCT01706250|Secondary|Mean Change in Each of the Participant Assessments of Tolerability-Burning|This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for burning. The area on the face was assessed excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the burning was graded on 0 to 5 scale based on severity by the participant; 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1, 2, 4 and 8) minus the value at BL respectively.|BL (Day 1) to Wks 1,2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).|||units on scale||Standard Deviation|Mean
2646078|NCT01706250|Secondary|Mean Change in Each of the Participant Assessments of Tolerability-Dryness|This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for dryness. The area on the face was assessed excluding the excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the dryness was graded on 0 to 5 scale based on severity by the participant. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated severity of the disease. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population . Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).|||units on scale||Standard Deviation|Mean
2646079|NCT01706250|Secondary|Mean Change in Each of the Participant Tolerability Assessments-Redness|This was a tolerability variable, where the participants were instructed to individually assess the right and the left side of the face to indicate the severity that they had experienced during the time period from their last visit for redness. The area on the face was assessed excluding the excluding nose, nasogenian, and superior and inferior eyelids. The assessment of the redness was graded on 0 to 5 scale based on severity by the participant. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wks 1,2,4 and 8) minus the value at BL respectively.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).|||units on scale||Standard Deviation|Mean
2646080|NCT01706250|Secondary|Mean Change in Each of the Evaluator Tolerability Assessments-Peeling|This was a tolerability variable. The expert grader (blinded evaluator) assessed each left and right side of the face individually at each study visit. The areas on the face excluding nose, nasogenian, and superior and inferior eyelids were evaluated. The evaluator conducting the assessment for the participant remained blinded for the treatment assigned. The assessment of the peeling was graded on 0 to 5 scale based on severity by the evaluator. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wk 1,2,4 and 8) minus the value at BL respectively. The change from BL was '0' for Wk (1, 4 and 8) and hence statistical analysis was not done.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points were analyze d (represented by n=x, x in the category titles).|||units on scale||Standard Deviation|Mean
2646081|NCT01706250|Secondary|Mean Change in Each of the Evaluator Tolerability Assessments-Dryness|This was a tolerability variable. The expert grader (blinded evaluator) assessed each left and right side of the face individually at each study visit. The areas on the face excluding nose, nasogenian, and superior and inferior eyelids were evaluated. The evaluator conducting the assessment for the participant remained blinded for the treatment assigned. The assessment of the dryness was graded on 0 to 5 scale based on severity by the evaluator. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated more severity. BL was defined as Day 1. The mean change was calculated as value at each individual visit (Wk 1,2,4 and 8) minus the value at baseline respectively. The change from BL was '0' for Wk 2, Wk 4, and Wk 8 and hence statistical analysis was not done.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).|||units on scale||Standard Deviation|Mean
2646123|NCT01706081|Secondary|Measurements for Bioimpedance for Treatment Arms at Baseline and 6 Weeks|Bioimpedance measured using Impedimed L-Dex U400, which measures the rate of electrical current transmission through tissues and estimate fluid content in a lymphedematous limb compared with the normal limb.|6 weeks||||ohms||Standard Deviation|Mean
2646082|NCT01706250|Secondary|Mean Change in Each of the Evaluator Tolerability Assessments-Erythema|This was a tolerability variable. The expert grader (blinded evaluator) assessed each left and right side of the face individually at each study visit. The areas on the face excluding nose, nasogenian, and superior and inferior eyelids were evaluated. The evaluator conducting the assessment for the participant remained blinded for the treatment assigned. Erythema is condition characterized by redness or rash on the skin. The assessment of the erythema was graded on 0 to 5 scale based on severity by the evaluator. 0=None, 1=Very minimal, 2=mild, 3= moderate, 4=severe, and 5= Very severe. Thus higher score indicated severity of the disease. BL was defined as Day 1. The mean change was calculated as value at each individual visit (wk 1,2,4 and 8) minus the value at BL respectively. The change from BL was '0' for Wk 4 and Wk 8, and hence statistical analysis was not done.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).|||units on scale||Standard Deviation|Mean
2646083|NCT01706250|Secondary|Mean Change in Investigator's Static Global Assessment (ISGA) From BL (Day 1) to Wks 1, 2, 4 and 8.|The evaluator (blinded) evaluated the acne severity of the participants' face using the ISGA scale ranging from 0 to 5. The grading was 0= Clear, skin with no IL or NILs; 1= Almost clear, rare NILs with no more than one small IL ; 2= Mild, some NILs with no more than few ILs (papules/pustules only, no nodular lesions); 3= Moderate Upto many NILs and may have some ILs but no more than one small nodular lesion ; 4= Severe, Upto many NILs and ILs but no more than a few nodular lesions; 5= Very severe, many NILS and ILs more than a few nodular lesions, may have cystic lesions. Thus higher score indicated severity of the disease. BL was defined as Day 1. The mean change was calculated as value at each visit (Wks 1,2,4 and 8) minus the value at BL respectively.|BL (Day 1) to Wks 1, 2, 4 and 8|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=x, x in the category titles).|||units on scale||Standard Deviation|Mean
2646084|NCT01706250|Secondary|Mean Percent Change in TL Count From BL (Day 1) to Wks 1, 2 and 4|This was an efficacy variable. An expert grader (blinded) evaluated the left and the right side of the face extending from the hairline to the mandible (included forehead, cheeks and chin). The evaluator assessed the total lesions by the sum of both inflammatory and non-inflammatory lesions on each side (left side and right side). The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. BL was defined as Day 1. The percent change was calculated as the percent value (count of total lesions) at each individual visit (percent value at Wks 1, 2 and 4) minus the value at baseline respectively.|BL (Day 1) to Wks 1, 2 and 4|ITT population. Only those participants available at the specified time points we re analyze d (represented by n=X, X in the category titles).|||percent change in lesion count||Standard Deviation|Mean
2646085|NCT01706250|Secondary|Mean Percent Change in NIL Count From BL (Day 1) to Wks 1, 2 and 4|This was an efficacy variable. An expert grader (blinded) evaluated the left and the right side of the face extending from the hairline to the mandible (included forehead, cheeks and chin). The evaluator assessed the NIL by the presence of open and closed comedones. The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. BL was defined as Day 1. The percent change was calculated as the percent value (count of NIL) at each individual visit (percent value at Wk 1, 2 and 4) minus the value at BL respectively.|BL (Day 1) to Wks 1, 2 and 4|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||percent change in lesion count||Standard Deviation|Mean
2646086|NCT01706250|Secondary|Mean Percent Change in IL Count From BL (Day 1) to Wks 1, 2 and 4|This was an efficacy variable. An expert grader (blinded) evaluated the left and the right side of the face extending from the hairline to the mandible (included forehead, cheeks and chin). The evaluator assessed the IL by counting the number of papules and pustules. The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. BL was defined as Day 1. The percent change was calculated as the percent value (count of IL) at each individual visit (percent value at wk 1, 2 and 4) minus the value at BL respectively.|BL (Day1) to Wks 1, 2 and 4|ITT used. Only those participants available at the specified time points were analyzed (re presented by n=x, x in the category titles).|||percent change in lesion count||Standard Deviation|Mean
2646087|NCT01706250|Primary|Mean Percent Change in Inflammatory Lesion (IL), Non-inflammatory Lesion (NIL), and Total Lesion (TL) Counts From Baseline (BL) (Day 1) to Week (Wk) 8.|This was an efficacy variable. An expert grader evaluated each side of the face (included forehead, cheeks and chin), the left and the right side, for IL (presence of papules and pustules), NIL (presence of open and closed comedones) and the TLs. The mouth, nose, periocular area, nasogenian, and superior and inferior eyelids were excluded. The evaluator was also blinded. BL was defined as Day 1. The percent change was calculated as the value at Wk 8 minus the value at BL.|BL (Day 1) and Wk 8|The Intent to treat (ITT) analysis set included data from all randomized participants who received the study drug. The number of participants available at that particular time point were used for analysis.|||percent change in lesion count||Standard Deviation|Mean
2646088|NCT01706198|Secondary|Number of Participants With Adverse Drug Reactions (ADRs)|An ADR is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, for which there is a reasonable possibility that the untoward occurrence is causally related to the medicinal product. ADRs are a subset of AEs for a given medicinal product.|Up to Week 52|ITT Population|||Participants|||Number
2646089|NCT01706198|Secondary|Number of Participants With SAEs|An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events which may require medical or surgical intervention for example, invasive or malignant cancers; all events of possible drug-induced liver injury with hyperbilirubinemia. The number of participants with on-treatment SAEs has been summarized.|Up to Week 52|ITT Population|||Participants|||Number
2646090|NCT01706198|Secondary|Number of Participants With Fatal SAEs of Pneumonia|"All SAEs included in the AESI group of pneumonia were considered as an SAE of pneumonia. Fatal SAEs of pneumonia are SAEs that led to death of participants. The number of participants with fatal SAEs of pneumonia has been presented."|Up to Week 52|ITT Population|||Participants|||Number
2646124|NCT01706081|Primary|Lymphedema as Measured at Baseline and at 6 Weeks|Changes in lymphedema between groups, as measured by mean arm circumference assessed at baseline and after 6 weeks from baseline.|6 weeks||||cm||Standard Deviation|Mean
2646091|NCT01706198|Secondary|Time to First SAE of Pneumonia|"An SAE of pneumonia was defined as any SAE in the AESI group of pneumonia. The date of an event for an SAE of pneumonia was the AE onset date. Participants who do not have an SAE of pneumonia during the first 364 days of the treatment period (start date of exposure to min [end date of exposure + 28 days, date of study discontinuation, start date of exposure + 363]) were censored. Time to first SAE of pneumonia was measured from the date of randomization (that is, study treatment start date) to the onset date of first SAE of pneumonia. The number of participants with first on-treatment SAE of pneumonia has been presented."|Up to Week 52|ITT Population|||Participants|||Number
2646092|NCT01706198|Secondary|Percentage of Participants With Serious Adverse Event (SAE) of Pneumonia|"A serious advent event (SAE) of pneumonia was defined as any SAE in the adverse event special interest (AESI) group of pneumonia. The incidence of the SAEs of pneumonia for each treatment group is defined as the percentage of participants in that group who have experienced at least one SAE of pneumonia from start date of study treatment to the stop date of exposure + 28 days or date of study discontinuation, whichever is earliest. The percentage of participants with SAE of pneumonia has been presented."|Up to Week 52|ITT Population|||Percentage of participants|||Number
2646093|NCT01706198|Secondary|Percentage of Participants Who Have an Increase From Baseline of >=0.5 in AQLQ(S) Environmental Stimuli Domain Score at Week 52.|"The AQLQ(S) contained 32 items under the following four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). The response format consisted of a seven-point scale where a value of 1 indicated total impairment and a value of 7 indicated no impairment. The total environmental stimuli domain score was calculated as the mean of the items within the environmental stimuli domain. Hence, the environmental stimuli domain scores were each defined on a range from 1 to 7 with higher scores indicating a higher quality of life. Baseline value is the value at Day 0 assessment. Change from Baseline is post dose visit value minus Baseline. The percentage of responders that is, participants with an increase from Baseline of >=0.5 in AQLQ(S) environmental stimuli domain score has been presented. Only those participants available at the specified time point was analyzed."|Baseline (Day 0) and Week 52|ITT Population|||Percentage of participants|||Number
2646094|NCT01706198|Secondary|Percentage of Participants Who Have an Increase From Baseline of >=0.5 in Standardized Asthma Quality of Life Questionnaire [AQLQ(S)] Total Score at Week 52.|"The AQLQ(S) contained 32 items under the following four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). The response format consisted of a seven-point scale where a value of 1 indicated total impairment and a value of 7 indicated no impairment. The total AQLQ(S) score is the mean of all 32 items in the questionnaire and each individual domain score was calculated as the mean of the items within that domain. Hence, the total and domain scores were each defined on a range from 1 to 7 with higher scores indicating a higher quality of life. Baseline value is the value at Day 0 assessment. Change from Baseline is post dose visit value minus Baseline. The percentage of responders that is, participants with an increase from Baseline of >=0.5 in AQLQ(S) total score has been presented. Only those participants available at the specified time point was analyzed."|Baseline (Day 0) and Week 52|ITT Population|||Percentage of participants|||Number
2646095|NCT01706198|Secondary|Time to Modification of Initial Therapy|Initial therapy is defined as the treatment that the participant was prescribed at randomization. Modification of initial therapy included any change in brand, dose or frequency of inhaler, that is, stepping up in class, dose or frequency, stepping down in class, dose or frequency, switching to another brand of inhaler, switching treatment arm or withdrawal from the study. Time to modification of initial therapy was measured from the date of randomization (that is, exposure start date) to the date of modification of initial therapy or date of treatment termination for participants who completed the study without modifiying initial therapy (censored). The number of participants with modification of initial therapy has been presented.|Up to Week 52|ITT Population|||Participants|||Number
2646096|NCT01706198|Secondary|Mean Number of Salbutamol Inhalers Prescribed for Each Participant Over the 12 Month Treatment Period.|Salbutamol was prescribed as a rescue medication to be used as and when necessary throughout the study. The number of salbutamol inhalers used by each participant during the study was calculated based on the total number of inhalers (adjusted to an equivalence of 200 metered actuations) prescribed. Number of salbutamol inhalers prescribed during the study was derived taking the participants time on study medication into account so it corresponds to 12 months on treatment. The least square mean number of salbutamol inhalers prescribed per participant during the study has been presented. Only participants exposed to study drug for at least 30 days were included in the analysis.|Up to 12 months|ITT Population|||Mean number of inhalers per participant||Standard Error|Least Squares Mean
2646097|NCT01706198|Secondary|Time to First Severe Asthma Exacerbation.|A severe asthma exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) or antibiotics, and inpatient hospitalization, or emergency department visit due to asthma that required systemic corticosteroids or antibiotics. The date of a severe asthma exacerbation was defined as the exacerbation onset date. Participants who completed the study without a severe asthma exacerbation were censored. Time to first severe asthma exacerbation was measured from the date of randomization (that is, study treatment start date) to the onset date of first severe asthma exacerbation, or study treatment stop date for participants who completed the study without any severe asthma exacerbations (censored). Analyses of time to first severe asthma exacerbation was censored at Day 364. The number of participants with severe asthma exacerbation has been presented.|Up to Week 52|ITT Population|||Participants|||Number
2646098|NCT01706198|Secondary|Mean Annual Rate of Severe Asthma Exacerbations|A severe asthma exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) or antibiotics, and inpatient hospitalization, or emergency department visit due to asthma that required systemic corticosteroids or antibiotics. Least square mean for annual rate of severe asthma exacerbation along with 95% confidence interval has been presented.|Up to Week 52|ITT Population|||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
2646125|NCT01706003|Primary|Assess the Utility of Telemedicine for Follow-up Care in a Headache Medicine Practice|Percentage of completed scheduled study visits for each group.|One Year||||percentage of scheduled appointments|||Number
2648473|NCT01685021|Secondary|Safety Will be Evaluated by Assessing Adverse Events, Clinical Lab Data and Vital Signs, ECG, Physical Exam|Number of patients with at least one treatment-emergent AE|weekly, up to 7 months||||patients|||Number
2646099|NCT01706198|Secondary|Number of Participants With Time to First Primary Care Contact|Time to first primary care contact is measured from the date of randomization (that is, study treatment start date) to the date of first primary care contact, or study treatment stop date for participants who completed the study without any primary care contacts (censored). Analyses of time to first primary care contact will be censored at Day 364. The number of participants at risk at Weeks 0, 13, 26, 39 and 52 has been presented. Kaplan Meier method of analysis was used. Study related primary care contacts (that is, contacts scheduled solely due to the participant taking part in clinical trial) were excluded from this analysis.|Up to Week 52|ITT Population|||Participants|||Number
2646100|NCT01706198|Secondary|Annual Rate of All On-treatment Primary Care Contacts|All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the NHS as identified in the EMR. Total primary care contacts is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional. The least square mean annual rate of all on-treatment primary care contacts along with 95% confidence interval has been presented.|Up to Week 52|ITT Population|||Contacts per participant per year||95% Confidence Interval|Least Squares Mean
2646101|NCT01706198|Secondary|Annual Rate of All On-treatment Secondary Care Contacts|A secondary care contact is defined as an inpatient admission or a specialist outpatient visit or an A&E contact. A participant with an A&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. The inpatient admissions recorded at two hospitals on the same day, were counted as a single (inpatient admission) secondary care contact. In the situation where inpatient admission periods overlapped (example, a new inpatient admission was recorded within the dates of an existing inpatient admission period), it was counted as a single (inpatient admission) healthcare contact with start date defined as the earliest inpatient admission date for either of the overlapping admissions and end date defined as the latest discharge date for either of the overlapping admissions. The least square mean annual rate of all on-treatment secondary care contacts along with 95% confidence interval has been summarized.|Up to Week 52|ITT Population|||Contacts per participant per year||95% Confidence Interval|Least Squares Mean
2646102|NCT01706198|Secondary|Number of Participants With Time to First Asthma-related Primary Care Contact|Asthma-related primary care contact is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional that can be considered as asthma-related as per Read codes. Time to first asthma-related primary care contact was measured from the date of randomization (that is, study treatment start date) to the date of first asthma-related primary care contact, or study treatment stop date for participants who completed the study without any asthma-related primary care contacts (censored). Analyses of time to first asthma-related primary care contact was censored at Day 364. The number of participants at risk at Weeks 0, 13, 26, 39 and 52 has been presented. Kaplan Meier method of analysis was used. Study related primary care contacts (that is, contacts scheduled solely due to the participant taking part in clinical trial) were excluded from this analysis.|Up to Week 52|ITT Population|||Participants|||Number
2646103|NCT01706198|Secondary|Annual Rate of Asthma-related Primary Care Contacts|All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the NHS as identified in the EMR. Contacts were defined to be asthma-related if the most prominent signs and symptoms that the participant presented were a direct result of the participant's asthma. Asthma-related primary care contacts is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional that can be considered as asthma-related as per Read codes. The least square mean annual rate of all asthma-related primary care contacts along with 95% confidence interval has been presented.|Up to Week 52|ITT Population|||Contacts per participant per year||95% Confidence Interval|Least Squares Mean
2646104|NCT01706198|Secondary|Annual Rate of Asthma-related Secondary Care Contacts|All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the National Health Service (NHS) as identified in the electronic medical records (EMR). Contacts were defined to be asthma-related if the most prominent signs and symptoms that the participant presented were a direct result of the participant's asthma. An asthma-related secondary care contact is defined as an inpatient admission or a specialist outpatient visit or an accident and emergency (A&E) contact. A participant with an A&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. The least square mean annual rate of all asthma-related secondary care contacts along with 95% confidence interval has been presented.|Up to Week 52|ITT Population|||Contacts per participant per year||95% Confidence Interval|Least Squares Mean
2646105|NCT01706198|Secondary|Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52.|The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants under each ACT total score category that is >=20, 16 to 19 and <=15 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Weeks 12, 24, 40 and 52|ITT Population|||Percentage of participants|||Number
2646106|NCT01706198|Secondary|Mean Change From Baseline in ACT Total Score at Weeks 12, 24, 40 and 52.|The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. Baseline value is the value at Visit 2 (Day 0) assessment. Change from Baseline is the value at post-dose visit minus Baseline. The least square mean change in ACT scores has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline (Day 0) and Weeks 12, 24, 40 and 52|ITT Population|||Scores on ACT scale||Standard Error|Least Squares Mean
2646107|NCT01706198|Secondary|Percentage of Participants Who Have an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 24, 40 and 52.|The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants with an increase in ACT total score >=3 from Baseline has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline (Day 0) and Weeks 12, 24, 40 and 52|ITT Population|||Percentage of participants|||Number
2646108|NCT01706198|Secondary|Percentage of Participants With Asthma Control (ACT Total Score >=20) at Weeks 12, 24, 40 and 52.|The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants with an ACT total score >=20 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Weeks 12, 24, 40 and 52|ITT Population|||Percentage of participants|||Number
2646109|NCT01706198|Secondary|Percentage of Participants Who Have Either an ACT Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 40 and 52.|The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. ITT Population comprised of all participants who were randomized and received at least one prescription of study medication. The percentage of responders that is participants with an ACT total score >=20 or an increase from Baseline of >=3 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).|Baseline (Day 0) and Weeks 12, 40 and 52|ITT Population|||Percentage of participants|||Number
2646110|NCT01706198|Primary|Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Week 24.|The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The primary efficacy analysis (PEA) Population is defined as all Intent-to-Treat (ITT) participants (that is, all participants who were randomized and received at least one prescription of study medication) who have an ACT total score of <20 at Baseline (Day 0). The percentage of responders that is participants with an ACT total score >=20 or an increase from Baseline of >=3 has been presented|Baseline (Day 0) and Week 24|PEA Population. Only participants with non-missing ACT score were analyzed.|||Percentage of participants|||Number
2646111|NCT01706159|Secondary|Maximum Concentration (Cmax) of rFXIII|The peak plasma concentration of the drug after dose administration.|Samples were collected before and up to 72 hours after the first dose of rFXIII.|It was not possible to obtain credible single dose PK for rFXIII in this trial due to a small number of subjects with required PK measurements and a spurious behaviour of individual PK profiles.||||||
2646112|NCT01706159|Secondary|Clearance (CL) of rFXIII|The volume of plasma cleared of the drug per unit time.|Samples were collected before and up to 72 hours after the first dose of rFXIII.|It was not possible to obtain credible single dose pharmakokinetics (PK) for rFXIII in this trial due to a small number of subjects with required PK measurements and a spurious behaviour of individual PK profiles.||||||
2646113|NCT01706159|Secondary|Number of Adverse Events (AEs)|Number of adverse events reported from the first trial-related activity, after the subject was exposed to the trial drug, until the end of the post-treatment follow-up period.|Week 0 to 10|Safety analysis set included all randomised and treated subjects.|||events|||Number
2646114|NCT01706159|Secondary|Remission (Clinical and Endoscopic)|Analysis of responders defined by a clinical component of: ulcerative colitis disease activity index (UC-DAI) score of less than or equal to 1 with 0 for rectal bleeding and 0 for stool frequency and an endoscopic component of: no mucosal friability (modified Baron score less than or equal to 1).|At Week 8|Full analysis set (FAS) included all randomised and treated subjects. Two subjects in the rFXIII group had no UC-DAI score at any visit, including baseline and they were excluded from the analysis.|||Subjects|||Number
2646115|NCT01706159|Primary|Endoscopic Remission Defined as a Modified Baron Score of 0|"The primary endpoint was the binary variable (responder vs. non-responder) where responders were the subjects with endoscopic remission (endoscopic mucosal healing) at Week 8, defined as a modified Baron score of 0. Subjects with a modified Baron score ≥1 were designated as non-responders."|At week 8|Full analysis set (FAS) included all randomised and treated subjects.|||Subjects|||Number
2646116|NCT01706146|Other Pre-specified|Stroke-free Survival Rate|To assess the stroke-free survival rate with implantable monitor-guided intermittent anticoagulation.|12 months|||||||
2646117|NCT01706146|Other Pre-specified|Major Bleeding-free Survival Rate|To assess the major bleeding-free survival rate with implantable monitor-guided intermittent anticoagulation.|12 months|||||||
2646118|NCT01706146|Other Pre-specified|Overall Survival|To assess the overall survival rate with implantable monitor-guided intermittent anticoagulation.|12 months|||||||
2646119|NCT01706146|Other Pre-specified|Stroke Rate|To assess the stroke rate with implantable monitor-guided intermittent anticoagulation.|12 months|||||||
2646120|NCT01706146|Secondary|Bleeding Incidence|To assess the bleeding incidence with implantable monitor-guided intermittent anticoagulation.|up to 12 months||||participants|||Number
2646126|NCT01705977|Secondary|Percentage of Participants Whose Average Prednisone (or Equivalent) Dose to Treat SLE Has Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52|The average daily prednisone dose during Weeks 40 to 52 is the sum of all prednisone doses to treat SLE from the day following the Week 40 visit date up to but not including the Week 52 study completion date divided by the number of days between Week 40 visit date and study completion date (study completion date - Week 40 visit date). Percentage of participants whose average prednisone dose has been reduced by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52 in participants with average prednisone use greater than 7.5 mg/day at Baseline was compared between belimumab and placebo using a logistic regression model including treatment group, Baseline prednisone dose, screening safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score (<=9 versus >=10) and region. Baseline is defined as the last available value measured prior to dosing on or before the date of first dose (Day 1).|Week 40 to Week 52|ITT Population. Only those participants with Baseline prednisone>7.5 mg/day were analyzed. The ITT population is defined as all participants who are randomized and received at least one dose of study agent and the analysis was performed per the treatment that a participant was randomized to receive, regardless of the actual treatment received.|||Percentage of Participants|||Number
2646127|NCT01705977|Secondary|Number of Participants With SAEs Reported During On-study Period|A SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-study period (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death) and was a supportive analysis period for safety analyses.|Up to Week 52 (On-study period)|As-Treated Population. One participant in placebo group who received belimumab >50% of the time was reported in the belimumab group.|||Participants|||Count of Participants
2646128|NCT01705977|Secondary|Number of Participants Who Reported Protocol Defined AESI: On-study Period|A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), NMSC, malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using C-SSRS) and SIHR is reported. The on-study period (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.|Up to Week 52 (On-study period)|As-Treated Population. One participant in placebo group who received belimumab >50% of the time was reported in the belimumab group.|||Participants|||Count of Participants
2646129|NCT01705977|Secondary|Number of Deaths Reported - On-study Period|Number of participants who died during on-study period is reported. The on-study period (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.|Up to Week 52 (On-study period)|As-Treated Population. One participant in placebo group who received belimumab >50% of the time was reported in the belimumab group.|||Participants|||Count of Participants
2646130|NCT01705977|Primary|Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period|An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-treatment period was defined as first dose to last dose + 28 days (or death) and was the primary analysis period for safety analyses.|Up to Week 52 (On-treatment period)|As-Treated Population. One participant in placebo group who received belimumab >50% of the time was reported in the belimumab group.|||Participants|||Count of Participants
2646131|NCT01705977|Primary|Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period|A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), non-melanoma skin cancer (NMSC), malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using Columbia-Suicide Severity Rating Scale [C-SSRS]) and serious infusion and hypersensitivity reactions (SIHR) is reported. The on-treatment period was defined as first dose to last dose + 28 days (or death). The on-treatment period was the primary analysis period for safety analyses.|Up to Week 52 (On-treatment period)|As-Treated Population. One participant in placebo group who received belimumab >50% of the time was reported in the belimumab group.|||Participants|||Count of Participants
2646132|NCT01705977|Primary|Number of Deaths - On Treatment Period|Number of participants who died during on-treatment period is reported. The on-treatment period was defined as first dose to last dose + 28 days (or death). The As-Treated Population was defined as all participants who were randomized and received at least one dose of study agent,grouped according to the actual treatment administered for the majority (>50%) of the time. The on-treatment period was the primary analysis period for safety analyses.|Up to Week 52 (On-treatment period)|As-Treated Population. One participant in placebo group who received belimumab >50% of the time was reported in the belimumab group.|||Participants|||Count of Participants
2646133|NCT01705730|Secondary|Erythrocyte Sedimentation Rate (ESR) Level|ESR is an acute phase reactant and is a measure of inflammation.|Baseline, Month 3, 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.|||millimeter per hour (mm/hr)||Standard Deviation|Mean
2646134|NCT01705730|Secondary|C-reactive Protein (CRP]) Level|CRP is an acute phase reactant and is a measure of inflammation.|Baseline, Month 3, 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.|||milligram per liter (mg/L)||Standard Deviation|Mean
2646135|NCT01705730|Secondary|Percentage of Participants With AEs Leading to Dose Modifications||Month 6|Safety population included all participants that received a dose of study drug.|||percentage of participants|||Number
2646160|NCT01705730|Secondary|Number of Participants With Starting Tocilizumab After Failing DMARDs||Baseline|Full analysis set included all participants that received at least one dose of tocilizumab during the study|||participants|||Number
2646136|NCT01705730|Secondary|Percentage of Participants With an Adverse Event (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. AESI included- serious/medically significant infections; myocardial Infarction/acute coronary syndrome; gastrointestinal perforations; malignancies; anaphylaxis/hypersensitivity reactions; demyelinating disorders; stroke; serious/medically significant bleeding events; serious/medically significant hepatic events.|Month 6|Safety population included all participants that received a dose of study drug.|||percentage of participants|||Number
2646137|NCT01705730|Secondary|Change From Baseline in VAS-Morning Stiffness at Month 3 and Month 6|Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.|Baseline, Month 3, 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.|||units on a scale||Standard Deviation|Mean
2646138|NCT01705730|Secondary|Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6|The Patient Global Assessment of pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.|Baseline, Month 3, 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.|||units on a scale||Standard Deviation|Mean
2646139|NCT01705730|Secondary|Change From Baseline in VAS-Fatigue at Month 3 and Month 6|The VAS-fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue and 100 indicates extreme fatigue. A decrease in the score indicates improvement.|Baseline, Month 3, 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.|||units on a scale||Standard Deviation|Mean
2646140|NCT01705730|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) at Month 3 and Month 6|The HAQ was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.|Baseline, Month 3, 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.|||units on a scale||Standard Deviation|Mean
2646141|NCT01705730|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6|"The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Month 3, 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.|||units on a scale||Standard Deviation|Mean
2646142|NCT01705730|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6|The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.|Baseline, Month 3, 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.|||units on a scale||Standard Deviation|Mean
2646143|NCT01705730|Secondary|Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response|The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP). SDAI total score = 0-86. A SDAI score </= 3.3 represented clinical remission, a score of between 3.4 and 11.0 represented low disease activity, a score between 11 and 26.0 represented moderate disease activity and a score > 26.0 represented high (or severe) disease.|Baseline, Month 3, 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.|||percentage of participants|||Number
2646144|NCT01705730|Secondary|Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response|CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician global assessment of disease activity (PhGH) assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Baseline, Month 3, 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.|||percentage of participants|||Number
2646161|NCT01705730|Secondary|Number of Participants With Dose Reductions||6 months|Full analysis set included all participants that received at least one dose of tocilizumab during the study.|||participants|||Number
2646310|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 57 to Day 84) for Use of Rescue Medication Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)||||rescue medication free days||90% Confidence Interval|Least Squares Mean
2646145|NCT01705730|Secondary|Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement. ACR50, ACR70, ACR90 require a 50%, 70%, 90% improvement from baseline respectively.|Month 3, 6|The ACR analysis was not performed because the Health Assessment Questionnaire (HAQ) disability index score is needed; only HAQ total score expressed in % was available.||||||
2646146|NCT01705730|Secondary|Percentage of Participants With Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6|Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (>=) -0.6, DAS28 >3.2 to <=5.1 or CFB>=-0.6 and DAS28 >5.1 or CFB >=-0.6. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH, and ESR. DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement.|Month 3, 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.|||percentage of participants|||Number
2646147|NCT01705730|Secondary|Percentage of Participants With Disease Activity Score-28 (DAS28)|DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and patient global assessment of disease activity (PGH) (measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 is a measurement of RA activity on a 0 to 10 scale: a score greater than (>) 5.1 indicates high disease activity; a score between 3.2 and 5.1 indicates moderate disease activity; a score of less than 3.2 indicates low disease activity; a score of less than (<) 2.6 is considered remission.|Baseline, Month 3, 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.|||percentage of participants|||Number
2646148|NCT01705730|Secondary|Swollen Joint Count (SJC)|SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.|Baseline, Month 3, 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.|||swollen joints||Standard Deviation|Mean
2646149|NCT01705730|Secondary|Tender Joint Count (TJC)|TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1.|Baseline, Month 3, 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.|||tender joints||Standard Deviation|Mean
2646150|NCT01705730|Secondary|Percentage of Participants With Reason for Choice of Monotherapy at Baseline||Baseline|Full analysis set included all participants that received at least one dose of tocilizumab during the study.|||percentage of participants|||Number
2646151|NCT01705730|Secondary|Percentage of Participants Still on Tocilizumab Monotherapy at Month 6||Month 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study.|||percentage of participants||95% Confidence Interval|Number
2646152|NCT01705730|Secondary|Number of Participants Who Were Not Adhering to Recommended Management of AEs||Month 6|Only participants experiencing 'adverse events and/or abnormal laboratory tests requiring modification of drug dosage' are taken into account for this analysis.|||participants|||Number
2646153|NCT01705730|Secondary|Percentage of Participants Who Were Not Adhering to Recommended Dosing Regimen||Month 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study.|||percentage of participants||95% Confidence Interval|Number
2646154|NCT01705730|Secondary|Time for Restoration of Initial Dosing Regimen||Month 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, number of participants analyzed signifies number of participants evaluated for this outcome measure.|||days||Full Range|Median
2646155|NCT01705730|Secondary|Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy||Month 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, number of participants analyzed signifies the participants who were evaluable for the outcome measure.|||percentage of participants|||Number
2646156|NCT01705730|Secondary|Mean Dosing Interval Per Participant at Month 6||Month 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study. Analysis was performed only participants reaching 6 month visit.|||days||Standard Deviation|Mean
2646157|NCT01705730|Secondary|Number of Dose Modifications Per Participant at Month 6|Number of dose modification per participant at Month 6 was reported.|Month 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study.|||number of dose modifications||Standard Deviation|Mean
2646158|NCT01705730|Secondary|Time to Reduction/Withdrawal of Corticosteroids||Month 6|Data was not collected for this outcome measure.||||||
2646159|NCT01705730|Secondary|Number of Participants With Starting Tocilizumab After Stopping Other Biologic Agents||Baseline|Full analysis set included all participants that received at least one dose of tocilizumab during the study|||participants|||Number
2646163|NCT01705730|Secondary|Time to Addition of Disease-Modifying Anti-rheumatic Drugs (DMARDs)|The time to DMARD addition equals to the time (days) between tocilizumab start and first start date of DMARDs.|Month 6|Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, number of participants analyzed are the participants who had addition of DMARDs during study.|||days||Full Range|Median
2646164|NCT01705730|Secondary|Number of Participants With Inadequate Response to Other Biologics||Baseline|Full analysis set included all participants that received at least one dose of tocilizumab during the study.|||participants|||Number
2646165|NCT01705730|Secondary|Number of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs) Intolerance and Inadequate Response||Baseline|Full analysis set included all participants that received at least one dose of tocilizumab during the study.|||participants|||Number
2646166|NCT01705730|Secondary|Percentage of Participants With Systemic Manifestations of RA at Baseline|Systemic manifestations of RA included anemia, fatigue, conventional risk factors for cardiovascular disease, C-Reactive Protein (CRP) above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis and interstitial lung disease. Participants were included if they experienced at least any one of the conditions.|Baseline|Data for this outcome measure was not collected.||||||
2646167|NCT01705730|Primary|Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation||Month 6 after treatment initiation|Full analysis set included all participants that received at least one dose of tocilizumab during the study.|||percentage of participants||95% Confidence Interval|Number
2646168|NCT01705717|Secondary|Percentage of Participants Who Died|Any cause of death (including non-liver disease related) was reported.|Diagnosis and End of Study, up to 36 months after diagnosis|All enrolled participants|||percentage of participants|||Number
2646169|NCT01705717|Secondary|Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC)||Diagnosis and End of Study, up to 36 months after diagnosis.|All enrolled participants|||percentage of participants|||Number
2646170|NCT01705717|Secondary|Percentage of Participants Who Progressed From CHC to Cirrhosis||Diagnosis and End of Study, up to 36 months after diagnosis.|All enrolled participants|||percentage of participants|||Number
2646171|NCT01705717|Secondary|Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion|HCV relapse was determined by PCR RNA diagnostic testing. Virological relapse was defined as subsequent reappearance of serum HCV RNA after completion of therapy in participants who achieved end of treatment virological response (undetectable HCV RNA). Biochemical relapse was defined as subsequent rise in serum alanine aminotransferase (ALT) level after end of treatment with normal ALT.|End of Study, up to 36 months after diagnosis.|All enrolled participants;|||percentage of participants|||Number
2646172|NCT01705717|Secondary|Percentage of Participants Who Were HCV Seronegative at the End of Treatment|End-of-treatment response (ETR) was defined as a negative result upon PCR RNA diagnostic testing at the end of treatment.|End of Study, up to 36 months after diagnosis.|All enrolled participants|||percentage of participants|||Number
2646173|NCT01705717|Primary|Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy|SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment.|6 months|All enrolled participants.|||percentage of participants|||Number
2646174|NCT01705691|Secondary|Adverse Events Experienced by Participants as a Measure of Toxicity.|Total patients with at least 1 AE.|Assessed through 24 months from randomization|Please refer to the AE section for more detail.|||participants|||Number
2646175|NCT01705691|Secondary|2-year Overall Survival (OS): Death From Any Cause From Time of Randomization Through 2 Years After Randomization.|Percentage of patients alive at 24 months.|Assessed through 24 months from randomization||||percentage of patients||95% Confidence Interval|Number
2646176|NCT01705691|Secondary|Recurrence Free Interval (RFI): The Time to Occurrence of Inoperable Progressive Disease and Local, Regional, and Distant Recurrence.|The percentage of patients free from recurrence at 24 months.|Assessed through 24 months from randomization||||percentage of patients||95% Confidence Interval|Number
2646177|NCT01705691|Secondary|Clinical Complete Response (ycCR) Following Neoadjuvant Therapy Assessed by Physical Exam at the Completion of Neoadjuvant Chemotherapy|The number of patients with clinical complete response.|At approximately 24 to 28 weeks from initiation of study therapy|1 patient in Arm 1 and 3 patients in Arm 2 are missing data. The N=18 for the paclitaxel group is because analysis was done on only patients with a palpable lesion at baseline.|||participants|||Number
2646178|NCT01705691|Secondary|Clinical Overall Response (cOR)(Complete and Partial) Assessed by MRI at the Completion of WP or Eribulin (Before AC)|Percentage of patients with clinical complete response (no significant enhancement on MR images) or clinical partial response (at least 30% decrease in the maximal diameter of the tumor)|12 weeks after initiation of study therapy||||percentage of participants|||Number
2646179|NCT01705691|Secondary|ypCR Nodes|Percentage of patients with no histologic evidence of cancer in axillary lymph nodes.|At the time of surgery approximately 24 to 28 weeks.|1 patient in Arm 1 was not analyzed due to inoperable, progressive disease. 2 patients in Arm 2 are missing data.|||percentage of participants|||Number
2646180|NCT01705691|Primary|Pathologic Complete Response Rate (ypCR) Following Neoadjuvant Therapy in Breast and Axillary Lymph Nodes|Percentage of patients with no histologic evidence of cancer in breast and axillary lymph nodes.|At the time of surgery approximately 24 to 28 weeks.|1 patient in Arm 1 was not analyzed due to inoperable, progressive disease. 2 patients in Arm 2 are missing data.|||percentage of participants|||Number
2646181|NCT01705652|Primary|PSA (Prostate Specific Antigen)|PSA decline to < 1.0 ng/ml at 3 months post end of radiation or surgery|3 months post end of radiation treatment or surgery|Radiation Group: One subject who did not complete the study was included as he did stay in the study through the 3 month post radiation treatment time period, and dropped out after that time.|||participants|||Number
2646182|NCT01705587|Secondary|Difference in Biochemical Markers of Bone Turnover|upfront therapy group compared to delayed therapy group and no therapy group|intervals over 12-18 months depending on treatment group|Funding unavailable for sample analysis.||||||
2646183|NCT01705587|Secondary|Quality of Life Improvements|Assessed by quality of life questionnaire (SF-36). There are 8 subscales each ranging from 0-100 with higher scores indicating better quality of life.|at 12 months||||units on a scale||Standard Error|Mean
2646186|NCT01705587|Primary|Radiologic Evidence of Healing|Number of participants with persistence of alignment as determined by a radiologist.|at 10 weeks for immediate teriparatide group|Based on orthopedic surgeons' assessment, x-rays were not deemed necessary in over 30% of patients at week 10. Results presented are for those who had x-rays at 10 weeks to assess persistence of alignment for safety purposes.|||Participants|||Count of Participants
2646187|NCT01705587|Primary|Radiologic Evidence of Bone Healing|The radiologic indices of fracture healing included (1) cortical continuity on two of four cortices, (2) persistence of alignment, (3) decreased conspicuity of fracture line, and (4) increased callus formation. For each of these indices, healing was graded on a scale of 1 to 4 with 1 = no change (less than 25%), 2 = minimum healing (25-50%), 3 = moderate healing (50-75%), and 4 = complete healing (greater than 75%). A composite score was calculated by summing the subscale scores for the 4 indices. Composite score scale ranged from 4 to 16 with higher scores indicating more complete healing. The primary grading was performed by a radiologist with expertise in musculoskeletal radiology, then independently repeated by a second radiologist, both of whom were blinded to the study allocation.|6, 12 months of treatment||||units on a scale||Standard Error|Mean
2646188|NCT01705574|Secondary|Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase||Baseline; Open-Label Extension Week 48|Participants in the OLE ITT Analysis Set with available on-treatment data were analyzed.|||cells/uL||Standard Deviation|Mean
2646189|NCT01705574|Secondary|Percentage of Participants Receiving STB or ATV+RTV+TVD With HIV-1 RNA < 50 Copies/mL at Week 48 of the Open-Label Extension Phase|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 of the open-label phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Open-Label Extension Week 48|Participants in the OLE ITT Analysis Set were analyzed.|||Percentage of participants|||Number
2646190|NCT01705574|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 for the STB Group as Determined by the US FDA-Defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 96|Participants in the ITT Analysis Set who received STB through 96 weeks were analyzed.|||Percentage of participants||95% Confidence Interval|Number
2646191|NCT01705574|Secondary|Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase||Baseline; Week 48|Participants in the ITT Analysis Set with available data were analyzed.|||cells/μL||Standard Deviation|Mean
2646192|NCT01705574|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 of the Double-Blind Phase as Determined by the US FDA-Defined Snapshot Algorithm|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 of the double-blind phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Participants in the Intent-to-Treat (ITT) Analysis Set (randomized and received at least one dose of study drug) were analyzed.|||percentage of participants|||Number
2646193|NCT01705509|Primary|Cardiopulmonary Exercise Test Parameters (CPET).|CPET parameters assessed will include the peak VO2: measures the peak transport of O2 to the tissues when O2 extraction from the blood is maximal; 2) the anaerobic threshold (AT): measures the sustainable work capacity in units of VO2; 3) the O2-pulse measurements at the AT and peak VO2: estimate stroke volume at those levels of exercise; and 4) the relationship of O2 uptake to work rate (ΔVO2/ΔWR): provides information on the ability of the cardiac output to increase.|30 days|Number of Participants who Reached CPET Milestones|||Participants|||Count of Participants
2646194|NCT01705496|Other Pre-specified|Determine the Sensitivity and Specificity of [124I]FIAU vs. Plain X-ray in Detecting Prosthetic Joint Infection|"The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which [124I]FIAU and X-ray are compared.~The trial failed primary outcome, and this secondary outcome was not analyzed."|30 hours|||||||
2646195|NCT01705496|Other Pre-specified|Estimate the Sensitivity and Specificity of Plain X-ray in Detecting Prosthetic Joint Infection|"The adjudication committee evaluation of a subject's infection status will be used as the standard of truth to which X-ray is compared.~The trial failed primary outcome, and this secondary outcome was not analyzed."|15 mins|||||||
2646196|NCT01705496|Other Pre-specified|Explore Whether the Adjudication Committee Evaluation of a Subject's Infection Status Correlates With Either of the Two Proposed Published Standards|"An independent adjudication committee will assess the totality of clinical information from each subject and assign them a status of infected or uninfected. The subject's infection status will be compared with either of the two proposed published standards to determine whether it corelates with any of the current consensus definitions or diagnostic algorithms.~The trial failed primary outcome, and this secondary outcome was not analyzed."|30 +/- 2 days|||||||
2646197|NCT01705496|Secondary|Understand the Prevalence of Prosthetic Joint Infection|The trial failed primary outcome, and this secondary outcome was not analyzed|30 +/- 2 days|||||||
2646198|NCT01705496|Secondary|Define PET-CT Interpretation Criteria That Best Differentiate Infected vs Non-infected Prosthetic Joints|The efficacy of [124I]FIAU could not be established due to the non-specific nature of the PET-CT signals caused by the metal artifacts from the prosthesis and pronounced muscle uptake of FIAU. It was impossible to define image review parameters for diagnosis of prosthetic joint infection.|30 +/- 2 days|||||||
2646199|NCT01705496|Secondary|Evaluate the Safety and Tolerability of [124I]FIAU|Safety will be monitored throughout the study for all subjects. safety will be assessed by monitoring of adverse events,vital signs,physical exams, and clinical laboratory tests including CBC, serum chemistry.|30 +/- 2 days|22 received the investigational drug. A single IV injection of 5 mCi [124I]FIAU was well tolerated in patients presenting with pain in a prosthetic joint.|||participants with adverse events|||Number
2646311|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 29 to Day 56) for Use of Rescue Medication Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)|Full Analysis set|||rescue medication free days||90% Confidence Interval|Least Squares Mean
2670360|NCT01487499|Secondary|Overall Survival|Subjects will be followed for 5 years or the remainder of the subject's life in order to determine long-term 5 year survival rates.|5 years|||||||
2646200|NCT01705496|Primary|Estimate the Sensitivity and Specificity of [124I]FIAU|"The sensitivity and specificity of [124I]FIAU in the detection of prosthetic joint infection was determined based on the correlation of the patient's infection status determined by an independent image reviewer and the infection status assessed by an adjudication committee.~Presence or absence of infection: Images were to be assessed and optimized on an ongoing basis. The single blinded reader was to assess independently the PET-CT images (attenuation corrected [AC] and non-AC PET plus the AC CT) and provide a diagnosis (infected or uninfected) using the chosen parameter(s) without knowing the results of the surgery. The radiology reviewer was not given any additional clinical information on the patient for reassessments relative to the initial reads. A separate central radiologist was to read the comparator X-rays independently for the presence or absence of infection. All pathology slides were to be read by a single pathologist. Local microbiology results were to be used."|30 hours|Out of 23 enrolled, only 22 received the investigational drug. One subject withdrew.|||percentage of participants||80% Confidence Interval|Number
2646201|NCT01705288|Secondary|Pain Assessment|Secondary outcome is to determine if rapid recovery can improve Visual Analogue Scale (VAS) for pain assessment. VAS scales are a horizontal line 100 mm in length with the left end labeled 'No pain' and the right end labeled 'Very severe pain'. The subject marks a point on the line that represents their perception of their current state. VAS score is determined by measuring the distance (mm) from the left end of the line to the point on the line marked by the subject. The range of possible values for this pain score is 0 to 100 mm.|Day 0|Measured in early patients only|||Score on a scale||95% Confidence Interval|Median
2646202|NCT01705288|Secondary|Pain Medications Used|Total daily narcotic pain medication used by patients. Narcotic use was standardized by conversion to morphine equivalents using the methods of Korff et al.|Post operative - day 2||||Morphine equivalents||95% Confidence Interval|Median
2646203|NCT01705288|Primary|Hospital Stay|Length of hospital stay for patients undergoing laparotomy on the gynecologic oncology service measured as whole days from the day of surgery until discharge|1 Month|Individuals randomized who underwent eligible surgery|||Days||95% Confidence Interval|Median
2646204|NCT01705236|Secondary|Number of Participants With Adverse Events|Number of participants with adverse events and specifically macular edema.|36 months|Safety Population (SAF). The SAF consisted of all subjects treated with fingolimod for whom safety information had been collected.|||Participants|||Count of Participants
2646205|NCT01705236|Secondary|Change From Baseline to Month 12, 24 and 36 in Ganglion Cell Inner Plexiform (GCIP)|"Change from baseline in GCIP to months 12, 24 and 36 (or last values in case of missing data) in the Full Analysis Set (FAS).~The change in Ganglion cell layer thickness (GCLT) had been defined as secondary endpoint in the protocol, but OCT measured the GCIP instead. This was done because both layers were not clearly separable by OCT. GCIP was calculated as mean of the inner sectors (nasal, superior, temporal, and inferior) and declared as usual parameter instead. This change was introduced prior to data base lock, but the derivation of GCIP was corrected after data base lock."|Baseline, month 12, month 24, month 36|Full Analysis Set (FAS). The FAS consisted of all subjects treated with fingolimod who had at least one post-baseline efficacy assessment.|||micrometer||Standard Deviation|Mean
2646206|NCT01705236|Secondary|Change From Baseline to Month 12, 24 and 36 in Total Macular Volume (TMV)|Change from baseline in TMV to months 12, 24 and 36 (or last values in case of missing data) in the Full Analysis Set (FAS).|12, 24 and 36 months|Full Analysis Set (FAS). The FAS consisted of all subjects treated with fingolimod who had at least one post-baseline efficacy assessment.|||Cubic millimeter||Standard Deviation|Mean
2646207|NCT01705236|Secondary|Change From Baseline to Month 12, 24 and 36 in Average Quadrant Retinal Nerve Fiber Layer Thickness (RNFLT)|Change from baseline in average quadrant RNFL thickness to months 12, 24 and 36 (or last values in case of missing data) in the Full Analysis Set (FAS). Average quadrant RNFL thickness was the average of valid measurements of the right and left eye and assessed by optical coherence tomography (OCT). Quadrant RNFL thickness were: Nasal-inferior; nasal-superior; temporal-inferior; temporal-superior.|Baseline, month 12, month 24, month 36|Full Analysis Set (FAS). The FAS consisted of all subjects treated with fingolimod who had at least one post-baseline efficacy assessment.|||micrometer||Standard Deviation|Mean
2646208|NCT01705236|Secondary|Change From Baseline to Month 12 and 24 in Average Retinal Nerve Fiber Layer Thickness (RNFLT)|Change from baseline in average RNFL thickness to months 12 and 24 (or last values in case of missing data) in the Full Analysis Set (FAS). Average RNFL thickness was the average of valid measurements of the right and left eye and assessed by optical coherence tomography (OCT).|Baseline, month 12, month 24|Full Analysis Set (FAS). The FAS consisted of all subjects treated with fingolimod who had at least one post-baseline efficacy assessment.|||micrometer||Standard Deviation|Mean
2646209|NCT01705236|Primary|Change From Baseline to Month 36 in Average Retinal Nerve Fiber Layer Thickness (RNFLT)|The primary endpoint was the change, i.e. the absolute difference, in average RNFL thickness from baseline to month 36 (or last values in case of missing data) in the Full Analysis Set (FAS). Average RNFL thickness was the average of valid measurements of the right and left eye and assessed by optical coherence tomography (OCT).|Baseline, month 36|Full Analysis Set (FAS). The FAS consisted of all subjects treated with fingolimod who had at least one post-baseline efficacy assessment.|||micrometer||Standard Deviation|Mean
2646210|NCT01705145|Secondary|Part B: Absolute Change From Baseline in Body Mass Index (BMI) at Week 24|BMI = (Weight [in kg]) divided by (Stature [in meters])^2. Data was reported as per the dose received and for overall participants.|Baseline, Week 24|Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.|||kilogram per square meter (kg/m^2)||Standard Deviation|Mean
2646211|NCT01705145|Primary|Part A: Plasma Concentration of Ivacaftor and Its Metabolites|Plasma concentration was reported for ivacaftor and its metabolites (hydroxymethyl ivacaftor [M1] and ivacaftor carboxylate [M6]) up to 24 hours post-dose on Day 4 (Hour 0 [pre-dose] on Day 1 and Day 4; 2, 3, 6, 24 hours post-dose on Day 4). Data was planned to be reported for overall participants in the period.|Part A: up to 24 hours post-dose on Day 4|Part A Safety set included all participants who received at least 1 dose of study drug in part A.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2646312|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 1 to Day 28) for Use of Rescue Medication Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)|Full analysis set|||rescue medication free days||90% Confidence Interval|Least Squares Mean
2646212|NCT01705145|Secondary|Part B: Absolute Change From Baseline in Stature at Week 24|Stature was measured as height if children could stand unassisted and follow directions; otherwise, stature was measured as length. Data was reported as per the dose received and for overall participants.|Part B: Baseline, Week 24|Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.|||centimeters (cm)||Standard Deviation|Mean
2646213|NCT01705145|Secondary|Part B: Absolute Change From Baseline in Weight at Week 24|Data was reported as per the dose received and for overall participants.|Part B: Baseline, Week 24|Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.|||kilograms (kg)||Standard Deviation|Mean
2646214|NCT01705145|Secondary|Part B: Absolute Change From Baseline in Sweat Chloride at Week 24|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Data was reported as per the dose received and for overall participants.|Part B: Baseline, Week 24|Part B Safety set included all participants who received at least 1 dose of study drug in part B. Number of participants analyzed is for participants who were evaluable for this outcome measure.|||millimole per liter (mmol/L)||Standard Deviation|Mean
2646215|NCT01705145|Secondary|Part B: Plasma Concentration of Ivacaftor and Its Metabolites|Plasma concentration was reported for ivacaftor and its metabolites (M1 and M6) up to 24 hours post-dose on Day 168 (Hour 0 [predose] on Day 1, 14, 56, 112, and 168; 2, 3, 6 hours post-dose on Day 14; 1 hour post-dose on Day 56; 4, 6 hours post-dose on Day 112; 24 hours post-dose on Day 168). Data was planned to be reported for overall participants in the period.|Part B: up to 24 hours post-dose on Day 168|Part B Safety set included all participants who received at least 1 dose of study drug in part B.|||ng/mL||Standard Deviation|Mean
2646216|NCT01705145|Primary|Part B: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs|"AE: any adverse change from participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. AE includes both serious and non-serious AE. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.~Related AEs includes all AEs for which the causality was either related to study drug or possibly related to study drug. Data was reported as per the dose received."|Part B: Up to 28 Weeks|Part B Safety set included all participants who received at least 1 dose of study drug in part B.|||participants|||Number
2646217|NCT01705145|Primary|Part A: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Related AEs|"AE: any adverse change from participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.~Related AEs includes all AEs for which the causality was either related to study drug or possibly related to study drug. Data was reported as per the dose received and for overall participants."|Part A: Up to 93 Days|Part A Safety set included all participants who received at least 1 dose of study drug in part A.|||participants|||Number
2646218|NCT01705106|Secondary|PK Drug Interaction Model|NONMEM software will be used to develop a model describing the drug interaction between capecitabine and celecoxib using PK data collected during the first four weeks of the study.|4 weeks|The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.||||||
2646219|NCT01705106|Secondary|Drug-related Toxicities|Ordinal logistic regression modeling will be used to explore the relationship between celecoxib AUC and toxicity.|Up to six months|The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.||||||
2646220|NCT01705106|Secondary|Response Rate|Logistic regression analysis will be performed to describe the relationship (if any) between celecoxib AUC and response rate.|Up to 2 years|The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.||||||
2646221|NCT01705106|Secondary|CYP2C9 Genotype|Polymorphisms *2 and *3 will be genotyped and analyzed for their impact on celecoxib AUC using analysis of variance (ANOVA), controlling for gender, age, and other covariates.|one week|The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.||||||
2646222|NCT01705106|Primary|AUC of Celecoxib on Combination Therapy (Day 14) and AUC of Celecoxib on Celecoxib Monotherapy(Day 7)|These parameters will be estimated for each subject under each treatment condition. The mean ratios (combination therapy/celecoxib monotherapy) will then be estimated together with 90% confidence intervals (CI).|Day 7 and 14 post treatment|The study was terminated early due to slow accrual, thus none of participants was analyzed. Data were not collected.||||||
2646223|NCT01705080|Secondary|Mean Change in Office Systolic Blood Pressure at 48 Months||Baseline and 48 months|Data were not collected for participants in Unassigned Group at 48 months.|||mmHg||Standard Deviation|Mean
2646224|NCT01705080|Secondary|Mean Change in Office Systolic Blood Pressure at 36 Months||Baseline and 36 months||||mmHg||Standard Deviation|Mean
2646225|NCT01705080|Secondary|Mean Change in Office Systolic Blood Pressure at 24 Months||Baseline and 24 months||||mmHg||Standard Deviation|Mean
2646226|NCT01705080|Secondary|Mean Change in Office Systolic Blood Pressure at 12 Months||Baseline and 12 months||||mmHg||Standard Deviation|Mean
2646227|NCT01705080|Secondary|Mean Change in Office Diastolic Blood Pressure at 48 Months||Baseline and 48 months|Data were not collected for participants in Unassigned group at 48 months.|||mmHg||Standard Deviation|Mean
2646228|NCT01705080|Secondary|Mean Change in Office Diastolic Blood Pressure at 36 Months||Baseline and 36 months||||mmHg||Standard Deviation|Mean
2646229|NCT01705080|Secondary|Mean Change in Office Diastolic Blood Pressure at 24 Months||Baseline and 24 months||||mmHg||Standard Deviation|Mean
2646253|NCT01704976|Primary|Physical Functional Performance|"Short physical performance battery (SPBB): The SPBB examines 3 areas of lower extremity function: standing balance (semi-tandem stand, side-by-side stand, full tandem stand), usual walking speed and ability to stand from a chair. These areas represent essential tasks important for independent living.~The scores range from 0 (worst performance) to 12 (best performance). SPPB 0-6 is Poor performance; SPPB 7-9 is Intermediate performance; SPPB 10-12 is High Performance."|after 4 weeks||||units on a scale||Inter-Quartile Range|Median
2646254|NCT01704846|Secondary|Mean Residence Time (MRTpo)|Mean residence time of the analyte in the body after oral administration. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.|||hour|Participants|Geometric Coefficient of Variation|Geometric Mean
2646255|NCT01704846|Secondary|Terminal Half-life (t1/2)|Terminal half-life of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.|||hours|Participants|Geometric Coefficient of Variation|Geometric Mean
2646256|NCT01704846|Secondary|Terminal Rate Constant (λz)|Terminal rate constant of the analyte in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.|||1/h|Participants|Geometric Coefficient of Variation|Geometric Mean
2646257|NCT01704846|Secondary|Time From Dosing to the Maximum Measured Concentration (Tmax)|"Time from dosing to the maximum measured concentration of the analyte in plasma.~Means presented are adjusted means and the standard deviation is actually the intra-individual coefficient of variation."|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.|||hours|Participants|Standard Deviation|Mean
2646258|NCT01704846|Secondary|Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)|"Area under the concentration-time curve of faldaprevir in plasma over the time interval from 0 extrapolated to infinity.~Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation."|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.|||ng*h/mL|Participants|Geometric Coefficient of Variation|Geometric Mean
2646259|NCT01704846|Primary|Maximum Measured Concentration (Cmax)|Maximum measured concentration of faldaprevir in plasma. Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation.|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.|||ng/mL|Participants|Geometric Coefficient of Variation|Geometric Mean
2646260|NCT01704846|Primary|Area Under the Curve of the Analyte From Time 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the time of the last quantifiable data point.~Geometric means presented are adjusted means and the coefficient of variation is the intra-individual geometric coefficient of variation."|3 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic (PK) set included all healthy subjects in the treated set who have evaluable pharmacokinetic variable in the treatment periods.|||ng·h/mL|Participants|Geometric Coefficient of Variation|Geometric Mean
2646261|NCT01704781|Secondary|Part A and B: Safety and Tolerability||Part A: 31 days and Part B: 26 weeks||||participants|||Number
2646262|NCT01704781|Secondary|Part B: Incidents of Delayed-type Hypersensitivity|Delayed-type hypersensitivity measured by induration and erythema.|26 weeks|The IIT population was used for this outcome measure. Data for one patient was not reported at week 26.|||Participants|||Count of Participants
2646263|NCT01704781|Secondary|Part B: Evaluate the Effect on HIV Viral Load|Results BLQ (<20 HIV copies/mL) have been replaced with BLQ/2 = 10 HIV copies/mL while 'not detected' results have been replaced with 0 HIV copies/mL.|26 weeks|ITT analysis set|||Copies/mL||Standard Deviation|Mean
2646264|NCT01704781|Secondary|Part B: Change in CD8 Count|Change in CD8 count from baseline to week 26.|26 weeks|Not all patients had quantifiable blood samples/counts at all time points|||10^6 cells/L||Standard Deviation|Mean
2646265|NCT01704781|Primary|Part B: Change in CD4 Count|Change in CD4 count from baseline to Week 26.|Week 26|Analysis was performed for both the Intent To Treat (ITT) and Per Protocol (PP) analysis set.|||10^6 cells/L||Standard Deviation|Mean
2646266|NCT01704781|Primary|Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time||31 days|ITT analysis set was used.|||10^6 cells/mL||Standard Deviation|Mean
2646267|NCT01704781|Primary|Part A: To Establish Highest Tolerated Dose of Lenalidomide, Dose-Limiting Toxicity|Number of participants in each of the three groups that experienced any dose-limiting toxicity.|31 days|ITT analysis set was used.|||Participants|||Count of Participants
2646268|NCT01704755|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.|within 12 weeks after the last dose of study drug|All randomized participants who received at least 1 dose of study drug with HCV RNA < LLOQ at the final treatment visit who completed treatment.|||Percentage of participants||95% Confidence Interval|Number
2646269|NCT01704755|Secondary|Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24|All randomized participants who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2646270|NCT01704755|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm|A sustained virologic response is defined as plasma Hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2646271|NCT01704755|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2646272|NCT01704651|Secondary|Postoperative Ileus Incidence|Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus.|Patients will be followed for 30 days postop|Intent to treat analysis|||participants|||Number
2646273|NCT01704651|Primary|Postoperative Length of Hospital Stay|Length of stay = date/time of hospital dismissal - date/time of end of surgery|Patients will be followed for the duration of their hospital stay, an expected average of 5 days|Intent to Treat analysis|||days||Standard Deviation|Mean
2646274|NCT01704599|Post-Hoc|EKG Categoryy Changes Related to Homocysteine Changes|Change in EKG ( normalize, unchanged, became abnormal) when homocysteine (Hcy) increased or decreased from week 16 on adalimumab to week 28 on adalimumab plus folic acid, vitamins B6 and B12 in adault psoriasis patients ages 18-65 with moderate to severe plaque psoriasis.|Week 16 to Week 28|8 adults with moderate to severe plaque psoriasis ages 18-65. 4 were studied. Four were not because homocysteine levels at both Week16 nd 28 were not drawn(1 of the 4 had SAE prior to Week 16).|||participants|||Number
2646275|NCT01704599|Post-Hoc|Psoriasis Change in Participants With High H. Pylori Titers and With Normal Titers.|Change in PASI from Week 16 after 16 weeks of adalimumab to Week 28 after another 12 weeks of adalimumab plus folic acid, vitamins B6 and B12 and Change reported by telephone 70 days after week 28|Week 16 to Week 28 and Week 28 to post study day 70|8 Adults ages 18-65 with moderate tosevere plaque psoriasis. 7 subjects studied. The 8th had SAE prior to Week 16.|||participants|||Number
2646276|NCT01704599|Post-Hoc|PASI Change in Participants With Baseline VEGF Above 140 pg/ml and in Participants With Normal Baseline VEGF|Baseline VEGF level at week zero related to PASI change Week 16 on adalimumab compared to Week 28 after additonal 12 weeks of adalimumab plus folic acid, vitamin B6 and B12 in adult psoriasis patients ages 18-65 with moderate to severe plaque psoriasis.High levels were greater than or equal to 140 pg/ml. Normal VEGF was below this level.|Week 16 and Week 28|8 adult participants with moderate to severe plaque psoriasis ages 18 to 65. Seven were analyzed. The one not analyzed had SAE prior to week16.|||participants|||Number
2646277|NCT01704599|Post-Hoc|PASI Change Related to Baseline Body Mass Index Above, Below and Equal to 27.3|Change in PASI from Week 16 on adalimumab to Week 28 on adalimumab, folic acid, vitamin B6 and B12 in adults ages 18-65 with moderate to severe plaque psoriasis.|Week 16 and Week 28|8 Adult subjects ages 18-65 with moderate to severe plaque psoriasis. 7 had PASI data both Week 16 and Week 28. The 1 who did not had SAE prior to Week 16.|||participants|||Number
2646278|NCT01704599|Primary|Number of Particpants With a Categorical PASI (Psoriasis Area and Severity Index) Change|PASI: formula based on body surface areas on head/neck, trunk, both arms & legs with disease quality grading induration, scale and erythema on participants ages 18-65 with moderate to severe plaque psoriasis measured at weeks 16 and 28.|Weeks 16 and 28|8 adults ages 18-65 with moderate to severe plaque psoriasis. Seven of 8 had PASI measured at weeks 16 and 28. One had SAE prior to week 16.|||participants|||Number
2646279|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Increasign and Decreasing Body Weight|Weight is how heavy a participant is. Weight in pounds of each study adult participant age 18-65 years with moderate to severe plaque psoriasis measured at weeks 16 and compared to week 28 of study.|Week 16 and Week 28|8 adults ages 18-65 with moderate to severe plaque psoriasis. Seven of 8 had weights taken weeks 0,4,16 and 28 allowing week16 and 28 analysis. One had weight taken only at weeks 0 and 4.|||participants|||Number
2646280|NCT01704599|Other Pre-specified|Number of Participants Who Fulfilled the Category of Having Height Measured|Height is the distance from the bottom (soles of feet ) to the top (top of head) of a person when that person is standing in this study using ruler in inches.Participants measured were adults age 18 or older with moderate to severe plaque psoriasis.|Week 0 at Start of Adalimumab|8 Adults with mild to moderate plaque psoriasis had their height measured at week 0 in inches.|||participants|||Number
2646281|NCT01704599|Other Pre-specified|Number of Participants Within Categories of Body Temperature Change|Using a thermometer for body temperature on degrees Fahrenheit. Participants to be measured were adults 18 years or older with moderate to severe plaque psoriasis with temperature to be measured at week 16 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.|Weeks 16 and 28|8 Subjects. Five had temperatures measured weeks 16 and 28. Three did not (one of the 3 had SAE prior to week16)|||participants|||Number
2646313|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Asthma Control Days||Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months|Full Analysis set|||asthma control days||90% Confidence Interval|Least Squares Mean
2646314|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 57 to Day 84) for Asthma Control Days||Baseline (last 14 days before randomization) and Treatment Period (Days 57 to 84)|Full Analysis set|||asthma control days||90% Confidence Interval|Least Squares Mean
2646282|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures:|Blood pressure is the force the heart exerts against the walls of arteries as it pumps the blood out to the body. The unit of measurement is millimeters of mercury (mm Hg). Pulse is the number of times your heart beats per minute. The unit of measurement is beats per minute (BPM). These test measurements compared in adults with moderate to severe plaque psoriasis week 16 after 16 weeks adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg vitamin B12.|Week 16 and Week 28|of 8 adults with moderate to severe plaque psoriasis, Seven participants were measured at week 16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12. One who had SAE prior to Week 16 did not..|||participants|||Number
2646283|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Positive Urine Pregnancy Test (Urine Hcg)|Women of childbearing years over age 18 with moderate to severe plaque psoriasis on no systemic therapy at week 0 of study.|At screening|Only 1 of the 8 subjects was a woman of childbearing years during the study.|||participant|||Number
2646284|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Elevated and Normal Helicobacter Pylori Antibody|Adult participants age 18 years or older with moderate to severe plaque psoriasis with serum IgG antibodies against Helicobacter pylori bacteria using commercial ELISA assay during the 28 week study.|Week 28 after 16 weeks of Adalimumab then 12 of Adalimumab-Vitamins|8 adult participants with moderate to severe plaque psoriasis with H. pylori titers measured during the 28 week study.|||participants|||Number
2646285|NCT01704599|Secondary|Number of Participants With Category Change in Serum Folic Acid Level.|Serum folic acid level in adults ages 18 and older with mild to moderate plaque psoriasis measured at week 16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab plus 12 weeks of adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.|Weeks 16 and 28|8 particpantts with psoriasis. Five had folic acid levels drawn weeks 16 and 28. Three did not (one of the 3 had a SAE prior to week 16).|||participants|||Number
2646286|NCT01704599|Secondary|Number of Participants Within the Categories of Increasing and Decreasing Serum Vitamin B6 Level|Serum vitamin B6 levels were to be measured weeks16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab and 12 weeks on adalimuamb, folic acid 5 mg, b6 100 mg and B12 1000 mcg in adult participants with moderate to sever plque psoriasis.|At Week 16 and Week 28|8 adults 18-65 with moderate to severe plaque psoriasis measured at weeks 16 and 28. .Four of 8 had levels drawn at weeks 16 and 28. Four did not. Of the four whoi did not one had a SAE prior to Week 16.|||participants|||Number
2646287|NCT01704599|Secondary|Number of Participants With Category Change in Vitamin B12 Blood Level|Adult participants 18 years or older with moderate to severe plaque psoriasis were to have serum B12 levels measures Weeks 0 (on no systemic psoriasis medication), 16 (on adalimumab) and week 28 (on adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.|At Week 16 and Week 28|8 adult participants ages 18-65 with moderate to severe plaque psoriasis. Five of 8 had B12 measured at weeks 16 and 28. Three did not. One of the 3 had SAE prior to week 16.|||participants|||Number
2646288|NCT01704599|Secondary|Number of Participants Within the Categories of Increasing and Decreasing Serum Homocysteine|Serum homocysteine measured at week 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumaband then 12 weeks of adalimumab plus 5 mg folic acid, 100mg B6 and 1000 mcg of B12 in adults ages 18-65 with moderate to sever plaque psoriasis..|Week 16 and Week 28|8 adults 18-65 with moderate to severe plaque psoriasis. 4 had levels measured at Week 16 and again at Week 28. Of the 4 not meausres 1 had a SAE prior to Week16.|||participants|||Number
2646289|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Increasing and Decreasing Serum Phosphorus|Serum phosphorus (P) levels were to be measured weeks16 and 28 in adult participants age 18 and older with moderate to severe plaque psoriasis at week 0 on no systemic psoriasis medication; week 16 after 16 weeks of adalimumab and at week 28 after 16 weeks of adalimumab plus 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.|Week 16 then Week 28|8 adults 18-65 years having moderate to severe plaque psoriasis. Five had levels measured at week 16 and and again at week 28 . Three did not . Of the 3 1 had SAE prior to week 16.|||participants|||Number
2646290|NCT01704599|Other Pre-specified|Number of Participants Within the Categories of Increasing and Decreasing Serum Magnesium|Serum magnesium (Mg) was to be measured at baseline, Week 16 (on adalimumab) and at week 28 (on adalimumab plus folic acid, vitamins B6 and B12) in adult participants age 18 or older with moderate to severe plaque psoriasis.|Weeks 16 and 28|8 Adults age 18-65 with moderate to severe plaque psoriasis.Five had results both weeks 16 and 28. Three did npot (of these 1 had SAE prior to week 16)|||participants|||Number
2646291|NCT01704599|Other Pre-specified|Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count)|Change in CBC parameter: white blood count or hemoglobin or hematocrit ( as measured week 16 on adalimumab and at week 28 after 12 more weeks on adalimuamb , folic acid, B6 and B12) in adults ages 18-65 with moderate to severe plaque psoriasis.|Week 16 and Week 28|8 adult participants with moderate to severe plaque psoriasis. Five had CBCs at both week 16 and week 28. three did not ( one of the 3 had a SAE pripor to week 16)|||participants|||Number
2646292|NCT01704599|Secondary|Number of Participants With Category Change in Serum VEGF (Vascular Endothelial Growth Factorl)|Adult particpants ages 18 or older with moderate to severe plaque psoriasis were to have serum VEGF measured at week 0 on no systemic psoriasis medication then at both weeks 16 on adalimumab and at week 28 on adalimumab plus folic acid, B6 and Vitamin B12. Subjects raniked by BMI week 0 low to high|At Screening visit, Week 16 on Humira, after another 12 weeks on Humira plus vitamins and if early termination|8 adult subjects age 18-65 with moderate to sefver plaque psoriasis. Five subjects had VEGF levels taken weeks 16 and 28. Three ( one wiht SAE prior to week 16) did not.|||participants|||Number
2646315|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 29 to Day 56) for Asthma Control Days||Baseline (last 14 days before randomization) and Treatment Period (Days 29 to 56)|Full Analysis set|||asthma control days||90% Confidence Interval|Least Squares Mean
2646316|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 1 to Day 28) for Asthma Control Days||Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)|Full Analysis set|||asthma control days||90% Confidence Interval|Least Squares Mean
2670361|NCT01487499|Secondary|Progression-free Survival||18 months|||||||
2646293|NCT01704599|Other Pre-specified|Number of Participants in the Categories of Normalizing, Unchanging and Newly Abnormal Electrocardiograms (EKGs)|An electrocardiogram (EKG) is used to evaluate the electrical activity of the heart by converting this activity into line tracings on paper.. Electrodes (small, plastic patches) are placed at certain locations on the chest, arms, and legs. When the electrodes are connected to an EKG machine by lead wires, the electrical activity of the heart is measured, interpreted, and printed out for the doctor's information and further interpretation. This test was to be administered to adults age 18 or older with moderate to severe plaque psoriasis patients at week 0, 16 and week 28 of this study.|Week 16 and then Week 28 after another 12 weeks on Humira plus vitamins and if early termination|8 adults with moderate to severe plaque psoriasis. Seven evaluated at weeks 0,16 and 28 for no change in electrocardiogram (EKG) , worsening arrhymia or improvement of arrhythmia at weeks 16 and 28. Five of 8 studied weeks 0,16 and 28; 1 at week 16 and 28. Two (one with the SAE prior to Week 16) did not have EKGs both at weeks 16 and 28.|||participants|||Number
2646294|NCT01704599|Other Pre-specified|Number of Participants in the Categories of Having and of Not Having a Serious Adverse Event (SAE)|A serious adverse event is hosptalization or death or pathology leading to early termination of a participant from the study. This was to be reported at anytime during the 28 week study of adult patients ages 18-65 with moderate to severe plaque psoriasis though categorized by Week 16 (on adalimumab alone, by Week 28 (on adalimuamb plus 3 B vitaminsand by day 70 post Week 28.|By Week 16, by Week 28 and by Day 70 post Week 28.|Adults ages 18-65 with moderate to severe plaque psoriasis.|||participants|||Number
2646295|NCT01704599|Other Pre-specified|Number of Participants in the Categories of Having and Not Having an Adverse Event|"Worsening psoriasis or development or worsening of measured condition or new pathology not seen by week 16 but developed at weeks 28 or first discoved by telephone call day 70 post study:~AE Humira only"|After Week 16 of study|8 adult participants ages 18-65 with moderate to severe plaque psoriasis. Seven assessed after week 16 and at Week 28 of study and assessed at day 70 post week 28 visit ( the latter by telephone). One subject had SAE prior to vitamin addition.|||participants|||Number
2646296|NCT01704599|Secondary|Number of Participants With a Categorical DLQI (Dermatology Life Quality Index) Change|DLQI is 10 questions examining impact of skin disease on quality of life: (1) symptoms & feelings (2) daily activities (3) leisure (4) work & school (5) personal relationship (6) treatment. To be administered to adults over 18 years with moderate to severe plaque psoriasis at week 0 (no systemic psoriasis medication);. weeks 16 ( after 16 weeks of adalimumab) and week 28 (after 16 weeks adalimumab then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12).|Week 16 and Week 28|8 adults with moderate to severe plaque psoriasis measured at weeks 16 and 28. Seven were measured weeks 16 and 28. One had SAE prior to week 16.|||participants|||Number
2646297|NCT01704599|Secondary|Number of Participants With a Categorical Change in Static Physician Global Assessment (sPGA):|Number of participants with a category change in Physician static Global Assessment (sPGA): 7 point score from 0 (clear) to 6 measuring amount of surface covered and plaque qualities: thickness & erythema plus scaling. Dynamic score compares baseline with either improvement/ worsening of the same factors measured in the sPGA using the 0-6 scoring range but focused on change. sPGA at weeks 16 AND 28. dynamic PGA to be categoically measured at.weeks16 and 28.|Week 16 and Week 28|8 adult participants with moderate to severe plaque psoriasis. 7 had static PGA scores weeks 16 and 28 and one had sPGA but SAE prior to week 16.|||participants|||Number
2646298|NCT01704521|Primary|Number of Participants With Sustained Virological Response at Week 12 (SVR12)|"Viral kinetic assessment using SVR 12 to either lead-in 4 weeks with PegInterferon + Ribavirin or no lead-in, followed by response guided therapy of 24 or 48 weeks based on viral response to treatment. Standard of care treatment stopping rules will be followed with assessment of viral response at week 12 of treatment."|Post-treatment at week 12|See baseline characteristics|||participants|||Number
2646299|NCT01704495|Secondary|Mean Plasma Concentration of AZD5069 at 1 Month||at 1 month|PK analysis set|||(nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2646300|NCT01704495|Secondary|Mean Plasma Concentration of AZD5069 at Day 7||Day 7|PK analysis set|||(nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2646301|NCT01704495|Secondary|Number of Uncontrolled Persistent Asthma Weeks During Treatment||Day 1 to end of the 6 months treatment period|Full analysis set|||uncontrolled persistent asthma weeks||Standard Deviation|Mean
2646302|NCT01704495|Secondary|Number of Participants With Uncontrolled Persistent Asthma Weeks at Baseline||Last 2 weeks before randomization|Full analysis set|||participants|||Number
2646303|NCT01704495|Secondary|Number of Well Controlled Asthma Weeks During Treatment||Day 1to end of the 6 months treatment period|Full Analysis set|||well controlled asthma weeks||Standard Deviation|Mean
2646304|NCT01704495|Secondary|Number of Participants With Well Controlled Asthma Weeks at Baseline||Last 2 weeks before randomization||||participants|||Number
2646305|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Night Time Awakenings Due to Asthma Symptoms||Baseline (last 14 days before randomization) and Treatment Period (Day 85 to 6 months)|Full analysis set|||night time awakenings||90% Confidence Interval|Least Squares Mean
2646306|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 57 to Day 84) for Night Time Awakenings Due to Asthma Symptoms||Baseline (last 14 days before randomization) and Treatment Period (Day 57 to Day 84)|full analysis set|||night time awakenings||90% Confidence Interval|Least Squares Mean
2646307|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 29 to Day 56) for Night Time Awakenings Due to Asthma Symptoms||Baseline (last 14 days before randomization) and Treatment Period (Day 29 to Day 56)|Full Analysis set|||night time awakenings||90% Confidence Interval|Least Squares Mean
2646308|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 1 to Day 28) for Night Time Awakenings Due to Asthma Symptoms||Baseline (last 14 days before randomization) and Treatment Period (Days 1 to 28)|Full analysis set|||night time awakenings||90% Confidence Interval|Least Squares Mean
2646309|NCT01704495|Secondary|Change From Baseline to Treatment Period (Day 85 to End of Treatment [6 Months]) for Use of Rescue Medication Free Days||Baseline (last 14 days before randomization) and Treatment Period (Days 85 to 6 months)|Full Analysis set|||rescue medication free days||90% Confidence Interval|Least Squares Mean
2670838|NCT01482091|Secondary|Hypotension|Participants who had hypotension within 30 min of study drug administration|Every 5 minutes until 30 minutes after study drug administration||||participants|||Number
2646321|NCT01704495|Secondary|Number of Patients Presenting Improvement From Baseline to End of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score|The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.|Baseline (Day 0) and 6 months after Day 0|Full Analysis set|||Participants with improvement|||Number
2646322|NCT01704495|Secondary|Change From Baseline to Overall Mean of Treatment Period in AQLQ(S) (Asthma Quality of Life Questionnaire Standardised Version) Overall Score|The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.|Baseline (Day 0), Treatment Period (1,3, and 6 months)||||Overall Score||90% Confidence Interval|Least Squares Mean
2646323|NCT01704495|Secondary|Number of Patients Presenting Improvement From Baseline to End of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version)|The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).|Baseline (Day 0) and 6 months after Day 0|Full Analysis set|||Participants with improvement|||Number
2646324|NCT01704495|Secondary|Change From Baseline to Overall Mean of Treatment Period in ACQ-5 (Asthma Control Questionnaire, 5-item Version) Total Score|The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).|Baseline (Day 0), Treatment Period (1,2,3,4, and 6 months)|Full Analysis set|||Units on a scale]||90% Confidence Interval|Least Squares Mean
2646325|NCT01704495|Secondary|Change From Baseline to 6 Months Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at six months are included in the analysis|Baseline (Day 0) and 6 months after Day 0|Full Analysis set|||L||90% Confidence Interval|Least Squares Mean
2646326|NCT01704495|Secondary|Change From Baseline to 4 Months Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at four months are included in the analysis|Baseline (Day 0) and 4 months after Day 0|Full Analysis set|||L||90% Confidence Interval|Least Squares Mean
2646327|NCT01704495|Secondary|Change From Baseline to 3 Months Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at three months are included in the analysis|Baseline (Day 0) and 3 months after Day 0|Full Analysis set|||L||90% Confidence Interval|Least Squares Mean
2646328|NCT01704495|Secondary|Change From Baseline to 2 Months Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at two months are included in the analysis|Baseline (Day 0) and 2 months after Day 0|Full Analysis set|||L||90% Confidence Interval|Least Squares Mean
2646329|NCT01704495|Secondary|Change From Baseline to 1 Month Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at one month are included in the analysis|Baseline (Day 0) and 1 month after Day 0|Full Analysis set|||L||90% Confidence Interval|Least Squares Mean
2646330|NCT01704495|Secondary|Change From Baseline to 2 Weeks Measurement of Post-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis|Baseline (Day 0) and 2 weeks after Day 0||||L||90% Confidence Interval|Least Squares Mean
2646331|NCT01704495|Secondary|Change From Baseline to 6 Months Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at six months are included in the analysis|Baseline (Day 0) and 6 months after Day 0|Full Analysis set|||L||90% Confidence Interval|Least Squares Mean
2646332|NCT01704495|Secondary|Change From Baseline to 4 Months Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at four months are included in the analysis|Baseline (Day 0) and 4 months after Day 0|Full analysis set|||L||90% Confidence Interval|Least Squares Mean
2646333|NCT01704495|Secondary|Change From Baseline to 3 Months Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at three months are included in the analysis|Baseline (Day 0) and 3 months after Day 0|Full analysis set|||L||90% Confidence Interval|Least Squares Mean
2646334|NCT01704495|Secondary|Change From Baseline to 2 Months Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at two months are included in the analysis|Baseline (Day 0) and 2 months after Day 0|Full analysis set|||L||90% Confidence Interval|Least Squares Mean
2646335|NCT01704495|Secondary|Change From Baseline to 1 Month Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at one month are included in the analysis|Baseline (Day 0) and 1 month after Day 0||||L||95% Confidence Interval|Least Squares Mean
2646336|NCT01704495|Secondary|Change From Baseline to 2 Weeks Measurement of Pre-bronchodilator FEV1|Only patients with both a non-missing value at baseline and visit at two weeks are included in the analysis|Baseline (Day 0) and 2 weeks after Day 0|Full analysis set|||L||90% Confidence Interval|Least Squares Mean
2646337|NCT01704495|Secondary|Total Number of Days on Oral Cortecosteroids, Due to a Worsening of Asthma Symptoms||From start of treatment up to 6 months|Full analysis set|||Days||90% Confidence Interval|Least Squares Mean
2646338|NCT01704495|Secondary|Total Number of Days of Asthma-specific Hospital Admission/Intensive Care Unit Admissions||From start of treatment up to 6 months|Full analysis set|||Days||90% Confidence Interval|Least Squares Mean
2646341|NCT01704456|Secondary|Chronic Pain Acceptance, CPAQ Pain Willingness|"The investigators will examine women's self-reported pain acceptance, activities engagement, by administering the CPAQ chronic pain acceptance questionnaire. The Chronic Pain Acceptance Questionnaire (CPAQ) measures the degree of acceptance of pain by chronic pain patients. It consists of 20 items measuring two domains: Activities Engagement and Pain Willingness. Total score range is from 0 - 120, with higher scores indicating higher levels of pain acceptance.~Subscales:~Activities engagement (11 items)- Q 1, 2, 3, 5, 6, 8, 9, 10, 12, 15, 19 [Scores Range: 0 - 66] Pain willingness (9 items)- Q 4, 7, 11, 13, 14, 16, 17, 18, 20 [Scores Range: 0 - 54]"|Pre-treatment, one month post-treatment, and 6 months post treatment.||||score on a scale||Standard Deviation|Mean
2646342|NCT01704456|Secondary|Chronic Pain Acceptance, Activities Engagement|"The investigators will examine women's self-reported pain acceptance, activities engagement, by administering the CPAQ chronic pain acceptance questionnaire. The Chronic Pain Acceptance Questionnaire (CPAQ) measures the degree of acceptance of pain by chronic pain patients. It consists of 20 items measuring two domains, Activities Engagement and Pain Willingness. Total score range is from 0 - 120, with higher scores indicating higher levels of pain acceptance.~Subscales:~Activities engagement (11 items)- Q 1, 2, 3, 5, 6, 8, 9, 10, 12, 15, 19 [Scores Range: 0 - 66] Pain willingness (9 items)- Q 4, 7, 11, 13, 14, 16, 17, 18, 20 [Scores Range: 0 - 54]"|Pre-treatment, one month post-treatment, and 6 months post-treatment.||||score on a scale||Standard Deviation|Mean
2646343|NCT01704456|Secondary|Pain Hypervigilance|The investigators will examine women's self-reported hypervigilance about pain by administering the Pain Vigilance and Awareness Questionnaire. The Pain Vigilance and Awareness Questionnaire (PVAQ) is a 16 item self-report measure to assess the awareness, vigilance, preoccupation and observation of pain. Sum total score [Scores Range: 0 - 80].|Pre-treatment, one month post-treatment, and 6 months post treatment.||||score on a scale||Standard Deviation|Mean
2646344|NCT01704456|Secondary|Pain Catastrophizing|"The investigators will examine women's self-reported pain catastrophizing by administering the Pain Catastrophizing Scale. The Pain Catastrophizing Scale (PCS) is a self-report questionnaire that asks participants to think about past painful experiences, or a specific experience of pain, and to indicate the degree to which they have any of the presented thoughts or feelings when they are experiencing pain. Each one of the 13-items is rated on a Likert scale from 0 (not at all) to 4 (all the time), where a higher total score indicates higher pain catastrophizing.~Subscales: Rumination- (4 items) 8, 9, 10, and 11 [Scores Range: 0 - 16] Magnification- (3 items) 6, 7, and 13 [Scores Range: 0 - 12] Helplessness- (6 items) 1, 2, 3, 4, 5, and 12 [Scores Range: 0 - 24] Sum of all items [Overall Range: 0 - 52]"|Pre-treatment, one month post-treatment, and 6 months post-treatment..||||score on a scale||Standard Deviation|Mean
2646345|NCT01704456|Secondary|Sexual Distress|The investigators will examine women's self-reported sexual distress by administering the Female Sexual Distress Scale-Revised. This is a 12-item self-report questionnaire assessing for sexuality related personal distress. Scores on the scale range from 0 - 48, where higher scores represent higher levels of distress.|Pre-treatment, one month post-treatment, and 6 months post-treatment.||||score on a scale||Standard Deviation|Mean
2646346|NCT01704456|Secondary|Sexual Function|"The investigators will examine women's self-reported sexual function by administering the Female Sexual Function Index (FSFI). The Female Sexual Function Index (FSFI) is a 19-item self-report questionnaire which assesses sexual function in women. It covers six sexual domains: lubrication, arousal, desire, pain, orgasm and satisfaction. Scores range from 7.2 - 36 where increase in sexual dysfunction is represented by lower scores.~Subscales:~Desire- 2, 3 [Subscale scores Range: 1.2 - 6] Arousal- 5,6,7,8 [Subscale Scores Range: 1.2 - 6] Lubrication- 9,10,11,12 [Subscale Scores Range: 1.2 - 6] Orgasm- 13, 14, 15 [Subscale Scores Range: 1.2 - 6] Satisfaction- 1, 16, 17 [Subscale Scores Range: 1.2 - 6] Pain- 18, 19, 20 [Subscale Scores Range: 1.2 - 6] Extra item: (4) have you been sexually active in past 4 weeks? (yes/no) [Scores Range 0 (no) - 1 (yes)]~Note: Ranges applicable only if question 4 was answered yes."|Pre-treatment, one month post-treatment, and 6 months post-treatment.||||score on a scale||Standard Deviation|Mean
2646347|NCT01704456|Secondary|Self-reported Pain During Penetration|"The investigators will measure self-report of pain during attempted or completed intercourse (or dildo entry for non-heterosexual women). Numeric Rating Scale that asked participants to rate the intensity of pain during vaginal penetration attempts with sexual intercourse or penetration over the past 4 weeks This question was rated on a 0 to 10 scale from no pain (0) to worst possible pain (10)."|Pre-treatment,one month post-treatment, and 6 months follow-up.||||score on a scale||Standard Deviation|Mean
2646348|NCT01704456|Primary|Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment|The investigators have selected pain intensity during a controlled examination as the primary endpoint in this study. Specifically, pain intensity at the vulvar vestibule will be assessed using a vulvalgesiometer. The vulvalgesiometer is an instrument that provides a measure of pain/sensitivity that can be standardized across time points. The vulvalgesiometer is calibrated to exert a fixed amount of pressure. In this study, 30 grams of pressure at the 1, 3, 4, 6, 8, 9, and 11 o'clock positions (randomly) around the vestibule will be applied using the vulvalgestiometer. Women will also report their pain at each site using a numeric rating scale from 0 (no pain) to 10 (worst pain ever).|Pre-treatment, one month post-treatment and 6 months post-treatment.||||score on a scale||Standard Deviation|Mean
2646349|NCT01704404|Other Pre-specified|Plasma Half-life|"Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.~Day 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours."|From baseline to day 7|The number of subjects reported for plasma half lives are based on the actual evaluable PK data.|||hours||Standard Deviation|Mean
2646350|NCT01704404|Other Pre-specified|Tmax|"Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.~Day 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours."|From baseline to day 7||||hours||Standard Deviation|Mean
2646351|NCT01704404|Other Pre-specified|Cmax|"Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.~Day 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours."|From baseline to day 7||||ng/mL||Standard Deviation|Mean
2646352|NCT01704404|Primary|Change From Baseline to Day 7 in Trough FEV1 (Forced Expiratory Volume in 1 Second)||From baseline to day 7||||FEV1 (mL)||Standard Error|Mean
2648978|NCT01681121|Secondary|Evaluate the Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual Maintenance of Wakefulness Test Trials for ADX-N05 vs. Placebo at Week 4||4 weeks|||||||
2646353|NCT01704287|Secondary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) - Overall Study|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, was also an AE. The number of participants who discontinued study drug due to an AE is presented.|Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)|The analysis population consisted of all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2646354|NCT01704287|Secondary|Number of Participants Who Experienced an Adverse Event (AE) - Overall Study|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study drug, was also an AE. Participants were included in the treatment group in which an AE was experienced. The number of participants who experienced at least one AE is presented.|Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)|The analysis population consisted of all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2646355|NCT01704287|Secondary|Duration of Response (DOR) - Initial Treatment Period|For participants who demonstrated a confirmed response (Complete Response [CR]: disappearance of all target lesions or Partial Response [PR]: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. DOR analysis was based on IRO assessment. Analysis of DOR was not planned or analyzed for the switch-to-pembrolizumab treatment groups. Median DOR for participants who demonstrated a confirmed response is presented.|Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)|The analysis population consisted of all randomized participants who demonstrated a confirmed response (CR or PR) per RECIST 1.1. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.|||Months||Full Range|Median
2646356|NCT01704287|Secondary|Best Overall Response (BOR) - Switch-to-Pembrolizumab Treatment Period|The BOR was assessed using RECIST 1.1 and was recorded from the start of the second line of study drug (pembrolizumab) until the last imaging assessment in this period. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For the switch-to-pembrolizumab treatment groups, BOR was based on independent review committee (IRC) assessment. The BOR for switched-to pembrolizumab treatment groups is presented.|Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)|The analysis population consisted of all randomized participants in ICC who switched to receiving pembrolizumab. Participants were included in the treatment group to which they were re-randomized (switched) for this efficacy analysis.|||Percentage of Participants|||Number
2646357|NCT01704287|Secondary|Best Overall Response (BOR) - Initial Treatment Period|BOR was assessed by independent radiology review using RECIST 1.1 and was recorded from randomization until the last imaging assessment in this period. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. BOR for the Initial Treatment Period was based on IRO. BOR for participants during the Initial Treatment Period is presented.|Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)|The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.|||Percentage of Participants|||Number
2646358|NCT01704287|Secondary|Overall Response Rate (ORR) - Initial Treatment Period|ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. Analysis of ORR was not planned or conducted for the switch-to-pembrolizumab treatment groups. The percentage of participants who experienced a CR or PR is presented. This was the final analysis for ORR.|Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)|The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.|||Percentage of Participants||95% Confidence Interval|Number
2646359|NCT01704287|Secondary|Final Overall Survival (OS) By Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status - Initial Treatment Period|OS was defined as the time from randomization to death due to any cause. Participants with an Allred Proportion Score (APS) ≥2 (membranous staining in ≥1% of cells for PD-L1) were considered to be PD-L1 Positive and participants with an APS of 0 or 1 were considered to be PD-L1 Negative. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS duration based on the product-limit (Kaplan-Meier) method for censored data by PD-L1 tumor expression status is presented.|Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)|The analysis population consisted of all randomized participants who had a PD-L1 tumor expression status assessment. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.|||Months||95% Confidence Interval|Median
2646360|NCT01704287|Primary|Final Overall Survival (OS) - Initial Treatment Period|OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS duration based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the final analysis for OS.|Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)|The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.|||Months||95% Confidence Interval|Median
2646361|NCT01704287|Primary|Interim Overall Survival (OS) - Initial Treatment Period|OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the interim analysis for OS.|Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)|The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.|||Months||95% Confidence Interval|Median
2646362|NCT01704287|Primary|Progression-free Survival (PFS) - Initial Treatment Period|PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. Analysis of PFS was based on an integrated radiology and oncology (IRO) assessment and was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median PFS based on the product limit (Kaplan-Meier) method for censored data is presented. This was the final analysis for PFS.|Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)|The analysis population consisted of all randomized participants. Participants were included in the initial treatment group to which they were randomized for the efficacy analysis.|||Months||95% Confidence Interval|Median
2646363|NCT01704261|Secondary|Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% at Week 24|The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) or <7.0% (53 mmol/mol) in the FAS population at Week 24.|24 weeks|The FAS Population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.|||Percentage of participants||95% Confidence Interval|Number
2646364|NCT01704261|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).|Baseline and Week 24|The FAS population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.|||mg/dL||95% Confidence Interval|Least Squares Mean
2646365|NCT01704261|Primary|Percentage of Participants Who Discontinued From the Study Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to Week 24|The ASaT Population was defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.|||Percentage of participants|||Number
2646366|NCT01704261|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to Week 27|All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.|||Percentage of participants|||Number
2646367|NCT01704261|Primary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.|Baseline and Week 24|The Full Analysis Set (FAS) population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.|||%A1C||95% Confidence Interval|Least Squares Mean
2646368|NCT01704196|Secondary|Reduction in Use (Weeks 1 - 11)|Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11|Baseline through week 11||||participants|||Number
2646369|NCT01704196|Primary|Abstinence (Weeks 10 - 11)|Number of subjects that abstained from cocaine from weeks 10 through 11|Weeks 10 - 11||||Participants|||Count of Participants
2646370|NCT01704079|Secondary|Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D|Subjects in the per protocol population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/mL)|Approximately 6 months|Per protocol|||participants|||Number
2646371|NCT01704079|Secondary|Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D|Subjects in the intent to treat population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/dL)|Approximately 6 months|Intent to treat|||participants|||Number
2646372|NCT01704079|Secondary|Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline|Number of subjects in the per protocol population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders|Approximately 6 months|Per protocol|||participants|||Number
2646373|NCT01704079|Primary|Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline|Number of subjects in the intent to treat population attaining mean decrease in plasma intact Parathyroid Hormone (iPTH) of ≥30% from P\pre-treatment baseline in the efficacy assessment phase (EAP) referred to as responders|Approximately 6 months|Intent to treat|||participants|||Number
2670839|NCT01482091|Secondary|Respiratory Distress|Participants who had respiratory distress within 30 min of study drug administration|Every 5 minutes until 30 minutes after study drug administration||||participants|||Number
2646374|NCT01703988|Secondary|Urine Pharmacokinetics: Renal Clearance, Cohort 4|Renal clearance of nusinersen for participants was assessed in the 12 mg reporting group only, per protocol.|Day 1 and Day 85|Pharmacokinetic (PK) Population, defined as all enrolled participants who have evaluable PK data|||mL/hr||Standard Deviation|Mean
2646375|NCT01703988|Secondary|Cerebrospinal Fluid (CSF) Pharmacokinetics: Predose CSF Drug Concentrations||Day 1, Day 29, and Day 85|PK Population, defined as all enrolled participants who have evaluable PK data; number analyzed=participants with an assessment at given time point. (This study includes participants previously enrolled in Study ISIS 396443 - CS1 (NCT01494701).|||ng/mL||Standard Deviation|Mean
2646376|NCT01703988|Secondary|Plasma Pharmacokinetics: Plasma Pharmacokinetics: Area Under the Plasma Concentration Time Curve From the Time of the IT Dose to 6 Hours After Dosing (AUC0-6hr)||Day 1 and Day 85|PK Population, defined as all enrolled participants who have evaluable PK data; number analyzed=participants with an assessment at given time point.|||ng*hr/mL||Standard Deviation|Mean
2646377|NCT01703988|Secondary|Plasma Pharmacokinetics: Time to Reach Cmax in Plasma||Day 1 and Day 85|PK Population, defined as all enrolled participants who have evaluable PK data; number analyzed=participants with an assessment at given time point.|||hours||Full Range|Median
2646378|NCT01703988|Secondary|Plasma Pharmacokinetics: Maximal Observed Plasma Drug Concentration (Cmax)||Day 1 and Day 85|Pharmacokinetic (PK) Population, defined as all enrolled participants who have evaluable PK data; number analyzed=participants with an assessment at given time point.|||ng/mL||Standard Deviation|Mean
2646379|NCT01703988|Primary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Discontinuations Due to AEs, and Highest Severity of AEs|An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the study or use of the investigational drug product, whether or not the AE is considered related to the investigational drug product. An SAE is any AE that, in the view of either the Investigator or Sponsor, meets any of the following criteria: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; and is an important medical event in the judgment of the investigator. Drug-related is an event related or possibly related to study drug. Severity of AEs was assessed as mild, moderate, or severe.|Participants were followed for the duration of the study; mean (SD) duration of treatment was 82.9 (15.4) days|Safety Population, defined as all enrolled participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2646380|NCT01703858|Secondary|Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)|Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity).|PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.|Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2646381|NCT01703858|Primary|Maximum Measured Concentration of the Analyte BI-113608 in Plasma (Cmax)|Maximum measured concentration of the analyte BI-113608 in plasma (Cmax).|PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.|Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2646382|NCT01703858|Primary|Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).|PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.|Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nanomol (nmol)* hours (h) / Litre (L)||Geometric Coefficient of Variation|Geometric Mean
2646383|NCT01703845|Secondary|Number of Participants With Clinically Relevant Abnormalities in Vital Signs, Clinical Laboratory Tests and ECG|"Outcome data show are the number of participants with clinically relevant abnormalities reported as an adverse event (AE) related to the vital signs (pulse rate and blood pressure in supine position), clinical laboratory (routine blood chemistry, haematology, and urinalysis) tests and ECG (12-lead holter monitoring Electrocardiography). Relevant findings or worsening of baseline conditions were reported as adverse events.~There were no clinically relevant abnormalities reported as an AE related to the vital signs and ECG."|up to 6 weeks (3 weeks treatment and 3 weeks follow-up) post dose|The treated Set (TS).|||participants|||Number
2646384|NCT01703845|Primary|CLR,t1-t2,ss (Tiotropium)|"Renal clearance from the time point t1 (0 h) until the time point t2 (4 h) at steady state (CLR,t1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type.~Plasma concentration of tiotropium could not be quantified up to 4 hours for Tiotropium + Olodaterol (2.5μg/5μg)."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2646385|NCT01703845|Primary|fe t1-t2,ss (Tiotropium)|"Fraction eliminated in urine from the time point t1 (0 h) to time point t2 (4 h) at steady state (fet1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.|||percentage of dose||Geometric Coefficient of Variation|Geometric Mean
2646386|NCT01703845|Primary|Aet1-t2,ss (Tiotropium)|"Amount of tiotropium that is eliminated in urine after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 4 hours at steady state (Aet1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.|||nanogram (ng)||Geometric Coefficient of Variation|Geometric Mean
2646387|NCT01703845|Primary|Tmax,ss (Tiotropium)|"Time from dosing to the maximum concentration of tiotropium after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (tmax,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.|||h||Full Range|Median
2646388|NCT01703845|Primary|AUC0-tz,ss (Tiotropium)|"Area under the concentration-time curve of tiotropium after multiple inhaled administration of tiotropium+olodaterol in plasma over the time interval from 0 to the time of the last quantifiable data point at steady state (AUC0-tz,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 h following drug administration on day 21|The Pharmacokinetic (PK) set.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2646389|NCT01703845|Primary|AUCt1-t2,ss (Tiotropium)|"Area under the concentration-time curve of tiotropium in plasma after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 2 hours at steady state (AUCt1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1 and 2 h following drug administration on day 21|The Pharmacokinetic (PK) set.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2646390|NCT01703845|Primary|Cmax,ss (Tiotropium)|"Maximum measured concentration of tiotropium after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (Cmax,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 minutes (min) pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 hours (h) following drug administration on day 21|The Pharmacokinetic (PK) set.|||picogram/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2646391|NCT01703845|Secondary|Number of Participants With Adverse Events (Including Assessment Based on Physical Examination)|Outcome data show are the number of patients with an adverse event including the assessment based on physical examination.|up to 6 weeks (3 weeks treatment and 3 weeks follow-up) post dose|Treated Set (TS) includes all randomised patients who received at least one dose of trial medication.|||participants|||Number
2646392|NCT01703845|Primary|CLR,t1-t2,ss (Olodaterol)|"Renal clearance from the time point t1 (0 h) until the time point t2 (4 h) at steady state (CLR,t1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2646393|NCT01703845|Primary|fe t1-t2,ss (Olodaterol)|"Fraction eliminated in urine from the time point t1 (0 h) to time point t2 (4 h) at steady state (fet1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.|||percentage of dose||Geometric Coefficient of Variation|Geometric Mean
2646394|NCT01703845|Primary|Aet1-t2,ss (Olodaterol)|"Amount of olodaterol that is eliminated in urine after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 4 hours at steady state (Aet1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|from 0 to 4 hours following drug administration on day 21|The Pharmacokinetic (PK) set.|||nanogram (ng)||Geometric Coefficient of Variation|Geometric Mean
2646395|NCT01703845|Primary|Tmax,ss (Olodaterol)|"Time from dosing to the maximum concentration of Olodaterol after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (tmax,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3 and 4 hours (h) following drug administration on day 21|The Pharmacokinetic (PK) set.|||h||Full Range|Median
2646396|NCT01703845|Primary|AUC0-tz,ss (Olodaterol)|"Area under the concentration-time curve of olodaterol after multiple inhaled administration of tiotropium+olodaterol in plasma over the time interval from 0 to the time of the last quantifiable data point at steady state (AUC0-tz,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 h following drug administration on day 21|The Pharmacokinetic (PK) set.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2646397|NCT01703845|Primary|AUCt1-t2,ss (Olodaterol)|"Area under the concentration-time curve of olodaterol in plasma after multiple inhaled administration of tiotropium+olodaterol over the time interval 0 to 4 hours at steady state (AUCt1-t2,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 min pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 h following drug administration on day 21|The Pharmacokinetic (PK) set.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2646398|NCT01703845|Primary|Cmax,ss (Olodaterol)|"Maximum measured concentration of olodaterol after multiple inhaled administration of tiotropium+olodaterol in plasma at steady state (Cmax,ss).~Per Protocol there are no primary endpoints defined. Therefore this pharmacokinetic endpoint was selected for primary outcome measure type."|15 minutes (min) pre-dose and 5, 10, 20, 40 min, 1, 2, 3, and 4 hours (h) following drug administration on day 21|The Pharmacokinetic (PK) set was defined as all treated patients who have at least 1 PK parameter in the treatment period without PK related important protocol violations. Two patients prematurely stopped the trial medication and had no PK measurement at Visit 3 (day 21) and were excluded from the PK set. Thus, the PK set included 30 patients.|||picogram/milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2646408|NCT01703832|Secondary|Changes in Saliva Cortisol|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||nmol/mL||Full Range|Median
2646399|NCT01703832|Secondary|Psychological Questionnaire (Modified Somatic SCL90)|"The SCL90 has 90 items with dimensions like depression, somatization, obsessive-compulsive disorder, social insecurity, anxiety, phobic anxiety, aggression/hostility, paranoid ideation, psychoticism and each item in a subscale ranged from 0 to 4. The lower range values are favorable outcomes and higher are worse outcomes. The modified somatic SCL90 uses the SCL90 somatization items, but instead of a 7 day timeframe asks for now. The corresponding items from SCL90 were: 1, 4, 12, 27, 40, 42, 48, 49, 52, 53, 56, 58 and the introductory question: How much do you currently suffer from (Wie sehr leiden Sie momentan unter:). The median of the average Modified Somatic SCL90 score is reported. The average score was calculated at each time point as the sum score divided by the number of non-missing individual question results for subjects with no more than 2 missing responses. The lower values in the range represent favorable outcomes while the higher values represent worse outcomes."|-210 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||units on a scale||Full Range|Median
2646400|NCT01703832|Secondary|State Anxiety and Stress Perception Measured by STAI-X1|"State anxiety and stress perception were measured by State-Trait Anxiety Inventory X1 before and after a stress test. The measurements took place 90 minutes before stress test and were repeated 15 and 100 minutes after the end of the stress test. The German version of the State-Trait-Anxiety Inventory was used and differentiates between temporary/emotional state anxiety versus personality trait anxiety. The two scales with 20 items each assess (1) anxiety as a trait (STAI-X2) and (2) anxiety as a state (STAI-XI). Answers are given in a 4-point rating scale ranging from 1 =not at all to 4 =very true. For analysis of each, STAI-scale single scores were summed up to one total score, representing the state and trait anxiety. Score range is 20-80 and higher scores indicate a higher anxiety."|-90 minutes, +15 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||units on a scale||Full Range|Median
2646401|NCT01703832|Secondary|Changes in Heart Rate|"Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording.~The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test."|-15 minutes, 0 minutes, +15 minutes, +45 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||beats per minute||Full Range|Median
2646402|NCT01703832|Secondary|Changes in Blood Pressure|"Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording.~The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test."|-15 minutes, 0 minutes, +15 minutes, +45 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||mmHg||Full Range|Median
2646403|NCT01703832|Secondary|Changes in Natural Killer (NK) Cells (Subgroup)|The Natural Killer Cells as immune cells and stress biomarkers were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|The test was only conducted in the Essen site where 15 participants randomized to Neurexan and 12 participants randomized to Natural Course could be evaluated for NK cells|||percentage of lymphocytes||Full Range|Median
2646404|NCT01703832|Secondary|Changes in Plasma Catecholamines (Norepinephrine)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. For plasma Norepinephrine evaluation 30 Neurexan and 23 Natural Course participants were evaluated due to insufficient sample.|||ng/L||Full Range|Median
2646405|NCT01703832|Secondary|Changes in Plasma Catecholamines (Epinephrine)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. For plasma Epinephrine evaluation 30 Neurexan and 23 Natural Course participants were evaluated due to insufficient sample.|||ng/L||Full Range|Median
2646406|NCT01703832|Secondary|Changes in Plasma Cortisol|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. For the plasma Cortisol evaluation 31 Neurexan and 24 Natural Course participants were evaluated due to insufficient sample.|||nmol/L||Full Range|Median
2646407|NCT01703832|Secondary|Changes in Plasma Adrenocorticotropic Hormone (ACTH)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|33 participants were randomized to Neurexan and 32 to Natural Course and all randomized participants were included in the Safety Set. For plasma ACTH evaluation 31 Neurexan and 24 Natural Course participants were evaluated due to insufficient samples and the -60 min time-point had 30 evaluable Neurexan participants.|||ng/L||Full Range|Median
2646409|NCT01703832|Secondary|Changes in Saliva Alpha Amylase|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minute, +15 minute , + 45 minute, +100 minute|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for efficacy. Note: -60 minute time-point had 31 evaluable Neurexan participants.|||IU/mL||Full Range|Median
2646410|NCT01703832|Primary|Acute Stress Measured by Nervousness|"Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0 = not at all to 100 = highly. The measurements started with first intake of Neurexan or Natural Course and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method."|-210 minutes to +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||mm*min||Full Range|Median
2646411|NCT01703832|Primary|Acute Stress Measured by Tension|"Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0 = not at all to 100 = highly. The measurements started with first intake of Neurexan or Natural Course and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method."|-210 minutes to +100 minutes|33 participants were randomized to Neurexan and 32 participants to Natural Course and all randomized participants were included in the Safety Set. 32 Neurexan and 32 Natural Course participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||mm*min||Full Range|Median
2646412|NCT01703819|Secondary|Psychological Questionnaire (Modified Somatic SCL90)|"The SCL90 has 90 items with dimensions like depression, somatization, obsessive-compulsive disorder, social insecurity, anxiety, phobic anxiety, aggression/hostility, paranoid ideation, psychoticism and each item in a subscale ranged from 0 to 4. The lower range values are favorable outcomes and higher are worse outcomes. The modified somatic SCL90 uses the SCL90 somatization items, but instead of a 7 day timeframe asks for now. The corresponding items from SCL90 were: 1, 4, 12, 27, 40, 42, 48, 49, 52, 53, 56, 58 and the introductory question: How much do you currently suffer from (Wie sehr leiden Sie momentan unter:). The median of the average Modified Somatic SCL90 score is reported. The average score was calculated at each time point as the sum score divided by the number of non-missing individual question results for subjects with no more than 2 missing responses. The lower values in the range represent favorable outcomes while the higher values represent worse outcomes."|-210 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||units on a scale||Full Range|Median
2646413|NCT01703819|Secondary|State Anxiety and Stress Perception Measured by STAI-X1|"State anxiety and stress perception were measured by State-Trait Anxiety Inventory X1 before and after a stress test. The measurements took place 90 minutes before the stress test and were repeated at 15 and 100 minutes after the end of the stress test. The German version of the State-Trait-Anxiety Inventory was used and differentiates between temporary/emotional state anxiety versus personality trait anxiety. The two scales with 20 items each assess (1) anxiety as a trait (STAI-X2) and (2) anxiety as a state (STAI-XI). Answers are given in a 4-point rating scale ranging from 1 =not at all to 4 =very true. For analysis of each, STAI-scale single scores were summed up to one total score, representing the state and trait anxiety. Score range is 20-80 and higher scores indicate a higher anxiety."|-90 minutes, +15 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||units on a scale||Full Range|Median
2646414|NCT01703819|Secondary|Changes in Heart Rate|"Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording.~The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test."|-15 minutes, 0 minutes, +15 minutes, +45 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||beats per minute||Full Range|Median
2646415|NCT01703819|Secondary|Changes in Blood Pressure|"Blood pressure and heart rate were measured before and after a stress test by continuous cardiovascular recording.~The measurements started 30 minutes before stress test and were repeated until 45 minutes after the end of the stress test."|-15 minutes, 0 minutes, +15 minutes, +45 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||mmHg||Full Range|Median
2646416|NCT01703819|Secondary|Changes in Natural Killer (NK) Cells (Subgroup)|The Natural Killer Cells as immune cells and stress biomarkers were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|The test was only conducted in the Essen site where 15 participants randomized to Neurexan and 16 participants randomized to Placebo could be evaluated for NK cells.|||percentage of lymphocytes||Full Range|Median
2646445|NCT01703663|Primary|Apnea-hypopnea Index|Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of sleep based on actigraphy. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The prespecified primary (absolute) treatment effect is based on the linear repeated measures model.|night 1 and night 2||||apneas plus hypopneas per hour||Inter-Quartile Range|Median
2646417|NCT01703819|Secondary|Changes in Plasma Catecholamines (Norepinephrine)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma Norepinephrine, 30 Neurexan and 26 Placebo participants were evaluated due to insufficient sample.|||ng/L||Full Range|Median
2646418|NCT01703819|Secondary|Changes in Plasma Catecholamines (Epinephrine)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma Epinephrine, 30 Neurexan and 26 Placebo participants were evaluated due to insufficient sample.|||ng/L||Full Range|Median
2646419|NCT01703819|Secondary|Changes in Plasma Cortisol|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma Cortisol, 31 Neurexan and 29 Placebo participants were evaluated due to insufficient sample.|||nmol/L||Full Range|Median
2646420|NCT01703819|Secondary|Changes in Plasma Adrenocorticotropic Hormone (ACTH)|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. For evaluation of plasma ACTH, 31 Neurexan and 29 Placebo participants were evaluated due to insufficient sample.|||ng/L||Full Range|Median
2646421|NCT01703819|Secondary|Changes in Saliva Cortisol|The stress biomarkers plasma and saliva cortisol and alpha amylase and Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||nmol/mL||Full Range|Median
2646422|NCT01703819|Secondary|Changes in Saliva Alpha Amylase|The stress biomarkers plasma and saliva cortisol, alpha amylase, Adrenocorticotropic Hormone and catecholamines (norepinephrine and epinephrine) were measured before and after a stress test. The measurements started 60 minutes before stress test and were repeated until 100 minutes after the end of the stress test.|-60 minutes, +15 minutes, +45 minutes, +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||IU/mL||Full Range|Median
2646423|NCT01703819|Primary|Acute Stress Measured by Nervousness|"Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0~= not at all to 100 = highly. The measurements started with first intake of Neurexan or Placebo and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the Area under the curve (AUC) method."|-210 minutes to +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||mm*min||Full Range|Median
2646424|NCT01703819|Primary|Acute Stress Measured by Tension|"Tension and nervousness were self-assessed by the participants on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) before and after a stress test. The VAS is used to determine the subjective impression of tension and nervousness on a 10 cm bipolar visual scale ranging from 0~= not at all to 100 = highly. The measurements started with first intake of Neurexan or Placebo and were repeated until 100 minutes after the end of the stress test. The total stress was then summarized with the area under the curve (AUC) method."|-210 minutes to +100 minutes|34 participants were randomized to Neurexan and 32 participants to Placebo and all randomized participants were included in the Safety Set. 34 Neurexan and 30 Placebo participants that could be evaluated for primary efficacy formed the Full Analysis Set for analysis of efficacy.|||mm*min||Full Range|Median
2646425|NCT01703741|Secondary|Average Concentration (Cave) for Total Testosterone and Dihydrotestosterone|"Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.~The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.|||ng/dL||Standard Deviation|Mean
2646446|NCT01703598|Primary|Change in Motor OFF Ldopa UPDRS|"Change in motor UPDRS in OFF Levodopa state. The range of this outcome is from 0 to 108, a higher number indicated a worse clinical state.~The number represents units on this scale."|Baseline and 6 months||||motor UPDRS||Standard Deviation|Mean
2646447|NCT01703507|Secondary|Number of Participants With Adverse Events and Serious Adverse Events||4 weeks following the last dose of ipilimumab||||Participants|||Count of Participants
2646426|NCT01703741|Secondary|Minimum Concentration Observed (Cmin) for Total Testosterone and Dihydrotestosterone|"Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.~The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.|||ng/dL||Standard Deviation|Mean
2646427|NCT01703741|Secondary|Maximum Concentration Observed (Cmax) for Total Testosterone and Dihydrotestosterone|"Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.~The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.|||ng/dL||Standard Deviation|Mean
2646428|NCT01703741|Secondary|Time at Which the Maximum Concentration (Tmax) Occurs for Total Testosterone and Dihydrotestosterone|"Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.~The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.|||hour||Full Range|Median
2646429|NCT01703741|Secondary|Area Under the Concentration-time Curve (AUCτ) for Total Testosterone and Dihydrotestosterone|"Measurement of total testosterone and DHT levels occur after subjects have been on a stabilized dose of Testosterone Gel for at least one month in the period between Month 3 and Month 6.~The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.|||ng*hr/dL||Standard Deviation|Mean
2646430|NCT01703741|Secondary|Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL|The data were presented using descriptive statistics.|At Month 6|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.|||percentage of subjects|||Number
2646431|NCT01703741|Secondary|Percentage of Subjects With a Serum Total Testosterone Level of 1500-1799, 1800-2499, or Above 2500 ng/dL|The data were presented using descriptive statistics.|At Month 3|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.|||percentage of subjects|||Number
2646432|NCT01703741|Secondary|Domain Scores for the Short Form-12 (SF-12) Questionnaire|"Data collected from the SF-12 questionnaire was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four sub-domains:~PCS: General Health (1 item), Physical Functioning (2 items), Role-Physical (2 items), Bodily Pain (1 item)~MCS: Role-Emotional (2 items), Mental Health (2 items), Vitality (1 item), Social Functioning (1 item)~The scale scores are calculated by summing responses across scale items and then transforming these raw scores to a 0-100 scale. Computerized scoring algorithms are used to produce norm-based scores for each scale (mean of 50 and SD of 10) as well as the PCS and MCS summary scores. A zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.~The data were presented using descriptive statistics."|At Month 6|ITT population was used which consists of all the subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available SF-12 questionnaire results.|||units on a scale||Standard Deviation|Mean
2646433|NCT01703741|Secondary|Domain Scores for the Multidimensional Assessments of Fatigue (MAF) Questionnaire|"The MAF contains four sub-domains:~Severity (2 items, questions 1-2) (Score range: 2-20)~Distress (1 item, question 3) (Score range: 1-10)~Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110)~Timing (2 items, questions 15-16) (Score range: 5-20)~A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain is categorical and was converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.~To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum scores of questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. Range of GFI: 1 (no fatigue) to 50 (severe fatigue).~The data were presented using descriptive statistics."|At Month 6|ITT population was used which consists of all subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available MAF questionnaire results.|||units on a scale||Standard Deviation|Mean
2646434|NCT01703741|Secondary|Percentage of Subjects With a Negative Androgen Deficiency in the Aging Male (ADAM) Questionnaire|"In ADAM questionnaire, subjects had to respond in yes or no to 10 questions. A positive result (with severity and symptoms of low testosterone) on the questionnaire was defined as an affirmative answer (yes) to questions 1 or 7, or to any 3 other questions.~The data were presented using descriptive statistics."|At Month 6|ITT population was used which consists of all the subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available ADAM questionnaire results.|||percentage of subjects|||Number
2646448|NCT01703507|Secondary|Progression Free Survival (PFS) Rate|PFS rate based on Response Evaluation Criteria in Solid Tumors (RECIST) and immune-related response criteria (irRC) criteria based on the brain MRI and systematic assessment by the treating physician|Up to 5 years||||Participants|||Count of Participants
2646449|NCT01703507|Secondary|Overall Survival (OS) Rate||Up to 5 years||||months||Full Range|Median
2670840|NCT01482091|Secondary|Change in Pain Score|Due to confounding factors we were unable to obtain reliable data for this outcome|Baseline and immediately prior to IV insertion|||||||
2646435|NCT01703741|Secondary|Domain Scores for the International Index of Erectile Function (IIEF) Questionnaire|"Data collected from the five domains of sexual functions were summarized by descriptive statistics.~The domains are:~Erectile function (6 items, questions 1-5 and 15) (Score range: 1-30)~Orgasmic function (2 items, questions 9-10) (Score range: 0-10)~Sexual desire (2 items, questions 11-12) (Score range: 2-10)~Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)~Overall satisfaction (2 items, questions 13-14) (Score range: 2-10)~A score of 0-5 is awarded to questions 1-10 and a score of 1-5 is awarded to questions 11-15. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function, in each domain."|At Month 6|ITT population was used which consists of all subjects who received at least one dose of the IMP. Of 145 treated subjects, 127 had available IIEF questionnaire results.|||units on a scale||Standard Deviation|Mean
2646436|NCT01703741|Secondary|Percentage of Subjects With a Serum Total Testosterone Level (Average Steady State Concentration [Cave]) Between 300 and 1050 ng/dL.|"Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.~The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.|||percentage of subjects|||Number
2646437|NCT01703741|Primary|Percentage of Subjects With a Serum Total Testosterone Level - Maximum Observed Concentration (Cmax) of 1500-1799, 1800-2499, or Above 2500 ng/dL|"Measurement of total testosterone level occur after subjects have been on a stabilized dose of testosterone gel for at least one month in the period between Month 3 and Month 6.~The data were presented using descriptive statistics."|Samples were collected at pre-dose; 2, 4, 6, 8, 10, 12 (±15 min for all), 18 (±2 hr), and 24 (±1 hr) hours post-dose (between Month 3 and Month 6, after subjects had been on a stabilized dose of Testosterone gel for at least 1 month)|PP analysis population was used which comprises data from subjects who had 24 hr PK data for testosterone, with no major protocol violations.|||percentage of subjects|||Number
2646438|NCT01703702|Secondary|Change in Patient Management: Individual Categories|Compare the percentage of patients with a change from baseline in the individual patient management categories at 3 months in the interventional and control arms.The individual categories are: Major diagnostic tests, Alzheimer's/cognition medication, neuropsychological tests, physician follow-up for re-evaluation or specialist referral.|Baseline and 3 months|Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.|||percentage of patients|||Number
2646439|NCT01703702|Secondary|Change in Caregiver Self-efficacy|Comparison of the change in self-efficacy between intervention and control arms. Change in self-efficacy is defined as the difference between total score on the Fortinsky: Family caregivers' self-efficacy for managing dementia scale at Follow-up (3 months) and baseline. Self-efficacy for managing dementia is defined in terms of specific behaviors or tasks that can be learned, and that are highly relevant to daily management of the disease process. The scale consists of 10 questions, each with responses ranging from 1 (not at all certain) to 10 (very certain). The total score is calculated by summing the response for each item. The total score ranges from 10 to 100, with increasing scores representing increasing caregiver self-efficacy.|Baseline and 3 months|Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.|||units on a scale||Standard Error|Least Squares Mean
2646440|NCT01703702|Secondary|Change in Patient Management: Advice/Counseling|Comparison of the percentage of patients in the intervention and control arms who have a change in management relating to advice and counseling from baseline to 3 months.|Baseline and 3 months|Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.|||percentage of patients|||Number
2646441|NCT01703702|Secondary|Change in Diagnostic Confidence|Comparison of the percentage point change in the physician's diagnostic confidence from baseline to month 3 in the intervention and control arms for patients whose scan result was predicted by their baseline clinical diagnosis. Diagnostic confidence was recorded by the physician as a whole number percent from 0-100% and the change in confidence was calculated by subtracting the baseline confidence from the confidence recorded at the specified timepoint. Values greater than zero reflect increased diagnostic confidence; values less than zero reflect decreased diagnostic confidence.|Baseline and 3 months|Analysis population for this endpoint only includes those patients whose scan result was predicted by their baseline clinical diagnosis and recorded both a baseline and follow-up value.|||Percentage Point||Standard Error|Least Squares Mean
2646442|NCT01703702|Secondary|Change in Patient's Clinical Diagnosis|Comparison of the percentage of patients who have a change in diagnosis from baseline to 3 months for patients in the intervention and control arms for whom the scan result was not predicted by the initial diagnosis.|Baseline and 3 months|Analysis population for this endpoint only includes those patients whose scan result was not predicted by their baseline clinical diagnosis and recorded both a baseline and follow-up value.|||percentage of patients|||Number
2646443|NCT01703702|Primary|Change in ADAS-Cog 11 Total Score|Change from baseline in the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) 11 Score in patients with mild impairment by positive or negative florbetapir (18F) PET scan result (Aß+/Aß-). ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 12 month score. A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.|Baseline and 12 months|Analysis population for this endpoint only includes those patients with mild cognitive impairment, and who reported both a baseline and follow-up value.|||units on a scale||Standard Error|Least Squares Mean
2646444|NCT01703702|Primary|Clinical and Diagnostic Change in Patient Management|Comparison of the percentage of patients who have a change in management from baseline to 3 months for patients who receive scan results immediately (intervention arm) and those who receive scan results 12 months later (control arm).|Baseline and 3 months|Analysis population for this endpoint only includes those patients with both a baseline and follow-up value.|||percentage of patients|||Number
2646450|NCT01703507|Secondary|Response of Extracranial Disease|Extracranial disease is assessed through repeated computed tomography of the chest, abdomen, and pelvis. The purpose of this scan is to determine if there is any evidence of disease outside of the brain.|Up to 5 years|Of the enrolled participants, only 4 out of 5 participants on Arm A and 9 out of 11 participants on Arm B had Extracranial Disease. Only these participants were included in this analysis|||Participants|||Count of Participants
2646451|NCT01703507|Secondary|Rate of Developing New Brain Metastases in Each Arm||Up to 5 years|Of the enrolled participants, only 7 developed new Brain Metastases (BMs) and were included in this analysis.|||months||Full Range|Median
2646452|NCT01703507|Primary|Maximum Tolerated Dose (MTD) of Ipilimumab|(MTD) when combined with WBRT or SRS, defined as the last dose studied or the previous dose, based on clinical judgment of the degree of toxicity seen at the last dose|30 days following the completion of radiation therapy||||mg/kg|||Number
2646453|NCT01703286|Secondary|Number of Patients With Adverse Events|Number of patients with any adverse events|up to 20 weeks|Treated set (TS)|||participants|||Number
2646454|NCT01703286|Secondary|Change From Baseline in 2 Hours Post Meal Endothelial Independent Vasodilation (EIDV) on Day 28|Endothelial function 2h post-meal was measured by endothelial independent vasodilation (EIDV). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.|baseline and day 28 for each treatment arm|Efficacy set (ES)- included all patients of the TS who provided at least 1 observation for at least 1 primary, secondary, or other efficacy endpoint without important protocol violations relevant for the statistical evaluation of these endpoints.|||percentage||90% Confidence Interval|Mean
2646455|NCT01703286|Secondary|Change From Baseline in Flow Mediated Vasodilation (FMD) 2 h Post Meal on Day 28|Endothelial function 2 hours post meal was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.|baseline and day 28 for each treatment arm||||Percentage||90% Confidence Interval|Geometric Mean
2646456|NCT01703286|Primary|Change From Baseline in Flow Mediated Vasodilation (FMD) Under Fasted Condition on Day 28|Endothelial function under fasted condition was measured with flow mediated vasodilation (FMD). The change from baseline was calculated as the value on Day 28 divided by the respective value at baseline.|baseline and day 28 for each treatment arm|Efficacy set (ES)- included all patients of the TS who provided at least 1 observation for at least 1 primary, secondary, or other efficacy endpoint without important protocol violations relevant for the statistical evaluation of these endpoints.|||percentage||90% Confidence Interval|Geometric Mean
2646457|NCT01703260|Secondary|Change From Baseline in Liver Fat Content at Month 4|Liver fat content was quantitatively measured by evaluating the percentage of PDFF from an abdominal MRI. On the basis of Couinaud classification (a classification used to describe functional liver anatomy), the liver was divided into 8 segments: caudate, left superolateral, left inferolateral, left superomedial (4a), left inferomedial (4b), right anteroinferior, right posteroinferior, right posterosuperior and right anterosuperior.|Baseline and Month 4|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline and at least 1 post-baseline assessment available.|||percent change in PDFF||Standard Deviation|Mean
2646458|NCT01703260|Secondary|Liver Fat Content at Baseline|Liver fat content was quantitatively measured by evaluating the percentage of proton density fat fraction (PDFF) from an abdominal magnetic resonance imaging (MRI). On the basis of Couinaud classification (a classification used to describe functional liver anatomy), the liver was divided into 8 segments: caudate, left superolateral, left inferolateral, left superomedial (4a), left inferomedial (4b), right anteroinferior, right posteroinferior, right posterosuperior and right anterosuperior.|Baseline|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline assessment available.|||percentage of PDFF||Standard Deviation|Mean
2646459|NCT01703260|Secondary|Percent Change From Baseline in Serum AST at Month 4|The percent change between the serum AST value collected at Month 4 or final visit relative to baseline.|Month 4|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline and at least 1 post-baseline assessment available.|||percent change||Standard Deviation|Mean
2646460|NCT01703260|Secondary|Amount of Serum Aspartate Transaminase (AST) at Baseline||Baseline|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline assessment available.|||IU/L||Standard Deviation|Mean
2646461|NCT01703260|Primary|Percent Change From Baseline in Serum ALT at Month 4|The percent change between the serum ALT value collected at Month 4 or final visit relative to baseline.|Month 4|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline and at least 1 post-baseline assessment available.|||percent change||Standard Deviation|Mean
2646462|NCT01703260|Primary|Amount of Serum Alanine Transaminase (ALT) at Baseline||Baseline|Safety analysis set included all participants who were randomized, received at least 1 dose of double-blind study medication and had baseline assessment available.|||international units per liter (IU/L)||Standard Deviation|Mean
2646463|NCT01703221|Secondary|Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24|Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).|Baseline and Week 24|The FAS Population consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.|||mg/dL||95% Confidence Interval|Least Squares Mean
2646464|NCT01703221|Secondary|Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24|Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.|Baseline and Week 24|The FAS Population consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.|||mg/dL||95% Confidence Interval|Least Squares Mean
2646478|NCT01703208|Secondary|Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/Mol) at 4 Months|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%).|4 months|Data for this efficacy endpoint was not collected, analyzed or summarized.||||||
2646465|NCT01703221|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.|Up to 52 weeks|The ASaT Population consisted of all randomized participants who received at least one study drug. Data was unavailable for 7 participants who discontinued the study in sitagliptin and placebo arms in Phase A.|||Percentage of participants|||Number
2646466|NCT01703221|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 24 weeks|The ASaT Population consisted of all randomized participants who received at least one study drug.|||Percentage of participants|||Number
2646467|NCT01703221|Primary|Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.|Up to 52 weeks|The ASaT Population included all randomized participants who received at least one study drug. Data was unavailable for 7 participants who discontinued the study in sitagliptin and placebo arms in Phase A.|||Percentage of Participants|||Number
2646468|NCT01703221|Primary|Percentage of Participants Who Experienced at Least One Adverse Event During Phase A|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 24 weeks|All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one study drug.|||Percentage of participants|||Number
2646469|NCT01703221|Primary|Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24|HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline).|Baseline and Week 24|The Full Analysis Set (FAS) consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.|||Percent HbA1c||95% Confidence Interval|Least Squares Mean
2646470|NCT01703208|Other Pre-specified|Number of Participants With an Event Per 100 Person-years of the Event of the First Hospitalization for Heart Failure (Exploratory)|Participants with adjudicated and confirmed events of first hospitalization for heart failure. Person-years were calculated as the sum of all participants' follow-up time to event.|Up to 179 weeks|The analysis population consisted of all participants who took at least one dose of blinded study medication.|||Participants/100 Person-years|||Number
2646471|NCT01703208|Other Pre-specified|Number of Participants With an Event of First Hospitalization for Heart Failure (Exploratory)|Participants with adjudicated and confirmed events of first hospitalization for heart failure.|Up to 179 weeks|The analysis population consisted of all participants who took at least one dose of blinded study medication.|||Participants|||Number
2646472|NCT01703208|Secondary|Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/Mol) at Week 18 in a Sub-Study of Participants Taking Insulin|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Analysis was performed with multiple data imputation.|18 weeks|The analysis population consisted of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.|||Percentage of participants||95% Confidence Interval|Number
2646473|NCT01703208|Secondary|Change From Baseline in FPG at Week 18 in a Sub-Study of Participants Taking Insulin|This change from baseline reflects the Week 18 FPG minus the Week 0 FPG.|Baseline and Week 18|The analysis population consisted of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2646474|NCT01703208|Secondary|Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 212 weeks|The analysis population included all randomized participants who took at least one dose of blinded study medication.|||Percentage of participants|||Number
2646475|NCT01703208|Secondary|Percentage of Participants Who Experienced at Least One Adverse Event|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 234 weeks|The analysis population included all randomized participants who took at least one dose of blinded study medication.|||Percentage of participants|||Number
2646476|NCT01703208|Secondary|Time to Initiation of Long-Term Insulin Therapy in Participants Not Receiving Insulin at Baseline|Long-term insulin therapy was defined as a continuous period of insulin use of more than 3 months.|Up to 179 weeks|Data for this efficacy endpoint was not collected, analyzed or summarized.||||||
2646477|NCT01703208|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 4 Months|This change from baseline reflects the Month 4 FPG minus the Week 0 FPG.|Baseline and 4 months|Data for this efficacy endpoint was not collected, analyzed or summarized.||||||
2646479|NCT01703208|Secondary|Change From Baseline in A1C at Week 142|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 142 A1C minus the Week 0 A1C.|Baseline and Week 142|The analysis population consisted of all randomized participants who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.|||Percent||95% Confidence Interval|Least Squares Mean
2646480|NCT01703208|Secondary|Number of Participants With an Event Per 100 Person-Years of the Event of All-Cause Death|All-cause death was death for any cause. Person-years were calculated as the sum of all participants' follow-up time to event.|Up to 179 weeks|The analysis population included all randomized participants who took at least one dose of blinded study medication.|||Participants/100 Person-years|||Number
2646481|NCT01703208|Secondary|Number of Participants With an Event of All-Cause Death|All-cause death was death from any cause.|Up to 179 weeks|The analysis population included all randomized participants who took at least one dose of blinded trial medication.|||Participants|||Number
2646482|NCT01703208|Secondary|Number of Participants With an Event Per 100 Person-Years of First Stroke (Fatal and Non-fatal)|Participants with adjudicated and confirmed AEs fatal and non-fatal stroke. Person-years were calculated as the sum of all participants' follow-up time to event.|Up to 179 weeks|The analysis population consisted of all participants who took at least one dose of blinded study medication.|||Participants/100 person-years|||Number
2646483|NCT01703208|Secondary|Number of Participants With an Event of Stroke (Fatal and Non-fatal)|Participants with adjudicated and confirmed AEs fatal and non-fatal stroke.|Up to 179 weeks|The analysis population consisted of all participants who took at least one dose of blinded study medication.|||Participants|||Number
2646484|NCT01703208|Secondary|Number of Participants With an Event Per 100 Person-Years of First MI (Fatal and Non-fatal)|Participants with adjudicated and confirmed AEs of fatal and non-fatal MI. Person-years were calculated as the sum of all participants' follow-up time to first event.|Up to 179 weeks|The analysis population consisted of all participants who took at least one dose of blinded study medication.|||Participants/100 person-years|||Number
2646485|NCT01703208|Secondary|Number of Participants With an Event of First MI (Fatal and Non-fatal)|Participants with adjudicated and confirmed AEs of fatal and non-fatal MI.|Up to 179 weeks|The analysis population consisted of all participants who took at least one dose of blinded study medication.|||Participants|||Number
2646486|NCT01703208|Secondary|Number of Participants With an Event Per 100 Person-Years of CV-Related Death|Participants with adjudicated and confirmed AEs of cardiovascular-related death. Person-years were calculated as the sum of all participants' follow-up time to event.|Up to 179 weeks|The analysis population consisted of all participants who took at least one dose of blinded study medication.|||Participants/100 person-years|||Number
2646487|NCT01703208|Secondary|Number of Participants With an Event of CV-Related Death|Participants with adjudicated and confirmed AEs of cardiovascular-related death.|Up to 179 weeks|The analysis population consisted of all randomized participants who received at least one dose of blinded study medication.|||Participants|||Number
2646488|NCT01703208|Primary|Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event in a Sub-Study of Participants Taking Insulin Excluding Data After Background AHA Change|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 18|The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.|||Percentage of participants|||Number
2646489|NCT01703208|Primary|Percentage of Participants Who Experienced at Least One Adverse Event in a Sub-study of Participants Taking Insulin Excluding Data After Background Antihyperglycemic Agent (AHA) Change|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 18|The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.|||Percentage of participants|||Number
2646490|NCT01703208|Primary|Change From Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin)|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C.|Baseline and Week 18|The analysis population consists of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.|||Percentage||95% Confidence Interval|Least Squares Mean
2646491|NCT01703208|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 18|A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C.|Baseline and Week 18|The analysis population consisted of all randomized participants who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.|||Percent||95% Confidence Interval|Least Squares Mean
2646492|NCT01703208|Primary|Number of Participants With an Event Per 100 Person-Years for First Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)|Participants with an event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke). Person-years were calculated as the sum of all participants' follow-up time to first event.|Up to 179 weeks|The analysis population included all randomized participants who took at least one dose of blinded trial medication.|||Participants/100 Person-years|||Number
2646493|NCT01703208|Primary|Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)|Participants with an Event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke).|Up to 179 weeks|The analysis population included all randomized participants who took at least one dose of blinded trial medication.|||Participants|||Number
2671367|NCT01476748|Primary|Trocar Slippages With LaproStop|Number of participants with slippages with LaproStop|During the hysterectomy procedure, up to 2 hours and 32 minutes|Pilot study|||Participants|||Number
2646494|NCT01703208|Primary|Number of Participants With MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina)|Participants with confirmed MACE-plus events (confirmed cardiovascular, CV-related death, nonfatal myocardial infarction [MI], nonfatal stroke, or hospitalization due to unstable angina). In the MK-3102-018 study, MACE plus events had a data cut-off date of April 15, 2015.|Up to 156 weeks|The analysis population included all randomized participants who took at least one dose of blinded study medication and were evaluated for MACE-plus events.|||Participants|||Number
2646495|NCT01703169|Secondary|Characterization of the PK Profile of Eltrombopag in Patients With Moderate to Very Severe Aplastic Anemia. Evaluated With AUC, Cmax, Cmin, Tmax.|Samples will for PK analysis will collected as a trough level weeks 2, 6 and 12, prior to dose of eltrombopag. Additional PK level drawn at 2, 4 and 6 hours post-dose at the scheduled week 2 visit.|Weeks 2, 6 and 12|Data was not collected for this outcome variable.||||||
2646496|NCT01703169|Secondary|Number of Patients With AE to Measure Toxicity, Using NCI CTCAE|Evaluated weekly, up to 12 weeks. Association between eltrombopag use, dose, and tolerability in patients with moderate to very severe aplastic anemia|12 weeks|Data was not collected for this outcome variable.||||||
2646497|NCT01703169|Secondary|Hematology Labs|Association between eltrombopag use and response in hemoglobin, hematocrit, total white blood cell count, and absolute neutrophil count to be evaluate by maximal hemoglobin, hematocrit, total white blood cell count, and absolute neutrophil counts achieved in patients with moderate to very severe aplastic anemia|12 weeks|Data was not collected for this outcome variable.||||||
2646498|NCT01703169|Secondary|Platelet Count Twice Baseline.|Proportion of subjects who achieve platelet counts at least twice their baseline value at any point while on study medication, in patients with moderate to very severe aplastic anemia.|Between weeks 1-12.|Data was not collected for this outcome variable.||||||
2646499|NCT01703169|Primary|Proportion of Participants With Platelet Response|Defined as a stable platelet count of 50,000/μl or more during any 4 week period within the possible 12 weeks while on study,and including maximal platelet counts achieved in patients with moderate to very severe aplastic anemia.|up to 12 weeks||||proportion of participants||95% Confidence Interval|Number
2646500|NCT01703091|Secondary|Change From Baseline in Lung Cancer Symptom Scale (LCSS)|The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using a visual analog scale (VAS) from 0 (best outcome) to 100 (worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom-specific items in the LCSS. The Total LCSS was the mean of all 9 LCSS items. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable.|Baseline to Measured Progressive Disease or Participant Stopped Study (up to 97 weeks)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.|||Millimeter||Standard Deviation|Mean
2646501|NCT01703091|Secondary|Change From Baseline in European Quality of Life Questionnaire - 5 Dimension (EQ-5D) Index Score|The EQ-5D is a quality-of-life instrument which allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).|Baseline, Day 21 Each Cycle (Cycle = 21 Days) and 30-Day Follow Up (Up to 97 Weeks)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.|||Units on a Scale||Standard Deviation|Mean
2646502|NCT01703091|Secondary|Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]|Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control equals (number of participants with CR, PR, or SD)/(number of participants assessed)*100.|Baseline to Measured Progressive Disease or Participant Stopped Study (Up to 97 Weeks)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.|||Percentage of Participants||95% Confidence Interval|Number
2646503|NCT01703091|Secondary|Percentage of Participants Who Achieved Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) [Objective Tumor Response Rate (ORR)]|Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. The percentage of participants who achieved an objective response equals (number of participants with CR or PR)/(number of participants assessed)*100.|Baseline to Measured Progressive Disease or Participant Stops Study (Up to 97 Weeks)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.|||Percentage of Participants||95% Confidence Interval|Number
2648979|NCT01681121|Secondary|Evaluate the Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (Average of the First Four Trials) Following Four Weeks of Treatment With ADX-N05 150 mg vs. Placebo||4 weeks|||||||
2646504|NCT01703091|Secondary|Overall Survival (OS)|OS was defined as time from baseline to the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow‑up) were censored on the last date the participant was known to be alive.|Baseline to Death from Any Cause (Up to 28 Months)|FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy. The number of censored participant data for ramucirumab and placebo is 36 and 35, respectively.|||Months||95% Confidence Interval|Median
2646505|NCT01703091|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from baseline until measured progressive disease (PD) or death from any cause, whichever is first. According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD, who were alive at the end of the follow-up period (or lost to follow‑up), were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.|Baseline to Measured Progressive Disease or Death from Any Cause (Up to 21 Months)|Full Analysis Set (FAS) population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy. The number of censored participant data for ramucirumab and placebo is 13 and 9, respectively.|||Months||95% Confidence Interval|Median
2646506|NCT01703065|Secondary|Changes in Biomarker Expression in Bone Biopsy Samples|To include MET, AKT, FASN and VEGFR2 expression and phosphorylation status (activation) in osteoblasts/osteoclasts and prostate cancer cells. Will also include changes in markers of apoptosis, proliferation, and angiogenesis.|Baseline and at 6 weeks|No nmCRCP patients enrolled, so no bone samples analyzed for this cohort. The purpose of biopsies in mCRPC cohort was to compare with those in nmCRPC cohort. Since no data to compare to, bone biopsy samples obtained were not analyzed. Only 1 patient with day 43 biopsy had specimen collected in both formalin and ethanol at baseline.||||||
2646507|NCT01703065|Secondary|Change in Lactic Acid Dehydrogenase (LDH) as a Marker of Bone Metabolism|Median percent change in Lactic Acid Dehydrogenase (LDH) from baseline compared to after 6 weeks of treatment with Cabozantinib.|Baseline and at 6 weeks|Lactic Acid Dehydrogenase (LDH) was analyzed in blood samples from 8 patients with metastatic CRPC at baseline and following 6 weeks of treatment. 1 participant did not provide a 6 week sample and was therefore excluded from this analysis. 0 participants were enrolled in the non-metastatic CRPC arm.|||percent change||Full Range|Median
2646508|NCT01703065|Secondary|Change in Alkaline Phosphatase as a Marker of Bone Metabolism|Median percent change in Alkaline Phosphatase from baseline compared to after 6 weeks of treatment with Cabozantinib.|Baseline, 6 weeks|Alkaline Phosphatase was analyzed in blood samples from 7 patients with metastatic CRPC at baseline and following 6 weeks of treatment. 2 participants did not provide a 6 week sample and were therefore excluded from this analysis. 0 participants were enrolled in the non-metastatic CRPC arm.|||percent change||Full Range|Median
2646509|NCT01703065|Secondary|Change in Bone Specific Alkaline Phosphatase as a Marker of Bone Metabolism|Median percent change in Bone Specific Alkaline Phosphatase from baseline compared to after 6 weeks of treatment with Cabozantinib.|Baseline and at 6 weeks|Bone Specific Alkaline Phosphate was analyzed in blood samples from 8 patients with metastatic CRPC at baseline and following 6 weeks of treatment. 1 participant did not provide a 6 week sample, and was therefore excluded from this analysis. 0 participants were enrolled in the non-metastatic CRPC arm.|||percent change||Full Range|Median
2646510|NCT01703065|Primary|Change in Urinary N-telopeptide (uNTX) as a Marker of Bone Metabolism in Non-metastatic Patients|Median percent change in Urinary N-Telopeptide from baseline compared to after 6 weeks of treatment with Cabozantinib in patients with non-metastatic prostate cancer.|Baseline and 6 weeks|Of 9 total patients enrolled, 0 had non-metastatic CRPC, therefore this outcome was not analyzed.||||||
2646511|NCT01703039|Secondary|Mean Change in Clinical Global Impression (CGI) Scale From Baseline (0 Weeks) to Endpoint at 8 Weeks|The Clinical Global Impression Scale (CGI) is a brief clinician-rated instrument. The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Treatment response ratings should take account of both therapeutic efficacy and treatment-related adverse events and range from 0 (marked improvement and no side-effects) and 4 (unchanged or worse and side-effects outweigh the therapeutic effects). Each component of the CGI is rated separately; the instrument does not yield a global score.|0 weeks-8 weeks||||score on a scale||Standard Deviation|Mean
2646512|NCT01703039|Secondary|Mean Change in Hamilton Anxiety Rating Scale (HARS) Score From Baseline (0 Weeks) to Endpoint at 8 Weeks|The HARS scale is a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It has 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicate less anxiety.|0 weeks-8 weeks||||score on a scale||Standard Deviation|Mean
2646513|NCT01703039|Primary|Number of Patients Experiencing Remission From Depression (HDRS<7) at Endpoint of 8 Weeks|The Hamilton Depression Rating Scale (HDRS) is a clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Higher HDRS scores indicate a worse outcome. The scale has a minimum value of 0 and a maximum value of 52.|0 weeks-8 weeks||||Participants|||Count of Participants
2646514|NCT01703039|Primary|Number of Patients Experiencing an Antidepressant Response (>50% Reduction in HDRS) at Endpoint of 8 Weeks|The Hamilton Depression Rating Scale (HDRS) is a clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Higher HDRS scores indicate a worse outcome. The scale has a minimum value of 0 and a maximum value of 52.|0 weeks-8 weeks||||Participants|||Count of Participants
2647013|NCT01699022|Primary|Serum Progesterone Concentration|"Return of ovulation measured by changes in serum progesterone concentration by~analysis on Day 18, Day 21 (Control cycle), Day 103, Day 106, Day 131 and Day 134 indicating the number of subjects who achieved ovulation"|Day 134||||participants|||Number
2646515|NCT01703039|Primary|Mean Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline (0 Weeks) to Endpoint at 8 Weeks|The Hamilton Depression Rating Scale (HDRS) is a clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Higher HDRS scores indicate a worse outcome. The scale has a minimum value of 0 and a maximum value of 52.|0 weeks-8 weeks||||score on a scale||Standard Deviation|Mean
2646516|NCT01703000|Secondary|Longitudinal Stent Deformation|Longitudinal stent deformation, evidenced by longitudinal compression or elongation, as the result of crossing a newly deployed stent with a second device, (such as a balloon catheter, stent system or IVUS catheter), causing the second device to become caught on the stent when the second device is advanced or retracted.|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||percentage of stents|||Number
2646517|NCT01703000|Secondary|Percent Net Volume Obstruction|The percentage of volume obstruction, as measured by the IVUS core lab.|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||% of volume|Participants|Standard Deviation|Mean
2646518|NCT01703000|Secondary|Incomplete Apposition|"Incomplete apposition rate, as measured by the IVUS core lab.~Binary assessment of presence of one or more stent struts separated from the vessel wall as detected through intravascular ultrasound (IVUS)."|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||percentage of lesions|Participants||Number
2646519|NCT01703000|Secondary|Lumen Volume|As measured by IVUS, the volume of the lumen.|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||mm^3|Participants|Standard Deviation|Mean
2646520|NCT01703000|Secondary|Stent Volume|As measured by IVUS, the volume of the stent.|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||mm^3|Participants|Standard Deviation|Mean
2646521|NCT01703000|Secondary|Vessel Volume|As measured by IVUS, the volume of the vessel.|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||mm^3|Participants|Standard Deviation|Mean
2646522|NCT01703000|Secondary|Lumen Area|As measured by IVUS, the area of the lumen.|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||mm^2|Participants|Standard Deviation|Mean
2646523|NCT01703000|Secondary|Stent Area|As measured by IVUS, the area of the stent.|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||mm^2|Participants|Standard Deviation|Mean
2646524|NCT01703000|Secondary|Vessel Area|As measured by IVUS, the mean vessel area (mm2).|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||mm^2|Participants|Standard Deviation|Mean
2646525|NCT01703000|Secondary|Acute Gain|Acute gain, as measured by angiographic core lab|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||mm||Standard Deviation|Mean
2646526|NCT01703000|Secondary|In-segment Minimum Lumen Diameter (MLD)|"As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-segment region (in-segment includes the stented region and 5 mm edge regions).~The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views."|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||mm|Participants|Standard Deviation|Mean
2646527|NCT01703000|Secondary|In-stent Minimum Lumen Diameter (MLD)|"As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-stent region.~The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views."|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||mm|Participants|Standard Deviation|Mean
2646528|NCT01703000|Secondary|In-segment Percent Diameter Stenosis (%DS)|"As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-segment region (in-segment includes the stented region and 5 mm edge regions).~Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100."|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||Diameter Stenosis, In-Segment (%)|Participants|Standard Deviation|Mean
2646529|NCT01703000|Secondary|In-stent Percent Diameter Stenosis (%DS)|"As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-stent region.~Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100."|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||In-Stent % Diameter Stenosis|Participants|Standard Deviation|Mean
2646530|NCT01703000|Secondary|Clinical Procedural Success Rate|"Clinical procedural success is post-procedure diameter stenosis <30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death.~MI definition used was the PLATINUM definition for MI."|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||percentage of participants||95% Confidence Interval|Number
2646531|NCT01703000|Secondary|Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)|"Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guide catheter has been removed and the patient left the catheterization lab.~Timing:~Acute stent thrombosis*: 0 24 hours after stent implantation~Subacute stent thrombosis*: >24 hours to 30 days after stent implantation~Late stent thrombosis: >30 days to 1 year after stent implantation~Very late stent thrombosis: >1 year after stent implantation * Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis is 0 30 days.~Stent thrombosis may be defined as:~Confirmed/definite~Probable~Possible~Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed)"|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
2646532|NCT01703000|Secondary|All Death/MI/TVR Rate|"Any event meeting the pre-specified criteria for any death, MI, or TVR.~MI definition used was the PLATINUM definition for MI."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
2646533|NCT01703000|Secondary|All Death or MI Rate|"Any all-cause mortality event or MI meeting the criteria defined for any death or MI.~MI definition used was the PLATINUM definition for MI."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
2646534|NCT01703000|Secondary|Cardiac Death or MI Rate|"Any cardiac death or MI event meeting the criteria defined for a cardiac death or MI.~MI definition used was the PLATINUM definition for MI."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
2646535|NCT01703000|Secondary|All Death Rate|Death is categorized as cardiac or non-cardiac deaths.|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
2646536|NCT01703000|Secondary|Non-cardiac Death Rate|"Non-cardiac death is defined as a death not due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~CVA through hospital discharge or CVA suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
2646537|NCT01703000|Secondary|Cardiac Death Rate|"Cardiac death is defined as death due to any of the following.~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~CVA through hospital discharge or CVA suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
2646538|NCT01703000|Secondary|Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate|MI will be defined according to the PLATINUM Definition of MI with evidence pre-specified for i) Spontaneous, ii) PCI-related, iii) CABG related, and iv) autopsy evidence criteria.|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
2646539|NCT01703000|Secondary|Target Vessel Failure (TVF) Rate|"Target vessel failure is any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.~The MI definition used was the PLATINUM MI definition."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
2646540|NCT01703000|Secondary|Target Vessel Revascularization (TVR) Rate|"Target vessel revascularization is defined as a TLR or a TVR remote. Target vessel revascularization remote is any ischemia-driven repeat percutaneous intervention, to improve blood flow, or bypass surgery of not previously existing lesions diameter stenosis >/= 50% by QCA in the target vessel, excluding the target lesion. A TVR will be considered ischemia-driven if the target vessel diameter stenosis is >/= 50% by QCA and any of the following are present:~The subject has a positive functional study corresponding to the area served by the target vessel.~The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.~The subject has ischemic symptoms referable to the target vessel. A TVR will also be considered as ischemia-driven if the lesion diameter stenosis is >/=70% even in the absence of clinical or functional ischemia."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
2646541|NCT01703000|Secondary|Target Lesion Failure (TLF) Rate|"Target lesion failure is any ischemia-driven revascularization of the target lesion, MI (Q-wave and non-Q-wave) related to the target vessel, or (cardiac) death. For the purposes of this protocol, if it cannot be determined with certainty whether the MI was related to the target vessel, it will be considered a TLF.~The MI definition used for Target Lesion Failure was the PLATINUM MI definition."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
2646542|NCT01703000|Secondary|Target Lesion Revascularization (TLR) Rate|"Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. A TLR will be considered as ischemia-driven if the target lesion diameter stenosis is >/= 50% by QCA and there is presence of clinical or functional ischemia which cannot be explained by other coronary or graft lesions. Clinical or functional ischemia is any of the following:~The subject has a positive functional study corresponding to the area served by the target lesion.~The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.~The subject has ischemic symptoms referable to the target lesion. A TLR will be considered as ischemia-driven if the lesion diameter stenosis is >/= 70% by QCA even in the absence of clinical or functional ischemia."|Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days||||percentage of participants|||Number
2646543|NCT01703000|Primary|Technical Success Rate|Technical success is defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||percentage of lesions|Participants|95% Confidence Interval|Number
2646544|NCT01702987|Primary|Phosphocreatine Recovery|Percentage change in phosphocreatine recovery from baseline to month as measured by 31PMRS is the primary outcome measure is a representative of mitochondrial oxidative capacity|1 month||||percentage change from baseline||Standard Error|Mean
2646558|NCT01702558|Secondary|Phase 1 (LA/mGC): AUC(0-inf) of Capecitabine|AUC(0-inf) is the measure of total drug exposure and is dependent on the total amount of drug absorbed. AUC(0-inf) for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.|Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1|Analysis was performed on Phase 1 PK analysis population for LA/mGC cohort.|||h*ng/mL||Standard Deviation|Mean
2647014|NCT01699022|Primary|T1/2|Mean no of days for MPA and E2|"Day 85"|Tmax|||day||Standard Deviation|Mean
2646545|NCT01702961|Secondary|Number of Participants With Overall Best Response Achieved After Transplantation|Response was summarized as complete remission (CR): disappearance of all evidence of disease; partial remission (PR): regression of measurable disease (>=50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses) and no new sites; stable disease (SD): failure to attain CR/PR/PD; relapsed disease or progressive disease (PD): any new lesion or increase by >= 50% of previously involved sites from nadir.|3 months post-transplant|Analysis comprised of all participants who received standard BEAM chemotherapy and adjuvant rituximab while undergoing autologous blood stem cell transplantation for high-risk lymphoma or Hodgkin’s disease.|||participants|||Number
2646546|NCT01702961|Secondary|Median Days to Neutrophil Engraftment|Neutrophil engraftment was recorded as the first day that absolute neutrophil counts (ANC) exceeds 0.5 X 10^9/L for three consecutive readings.|30 days post-transplant|All of the participants enrolled in the study engrafted.|||days||Full Range|Median
2646547|NCT01702961|Primary|Disease-free Survival|Disease-free survival at 12 months post-transplant in patients with Hodgkin's disease or non-Hodgkin's lymphomas|12 months post-transplant||||percentage of participant||95% Confidence Interval|Number
2646548|NCT01702909|Secondary|Median Survival|from time of study entry until death|measured from date of first dose until date of death|There are no data recordings for this study. The study was terminated and the investigator is no longer related to the site. There is no additional information to provide.||||||
2646549|NCT01702909|Secondary|Median Duration of Response|Duration of response is calculated as the time (months) from the date at which response is first observed (per standard Response Evaluation Criteria In Solid Tumors [RECIST] to the date of first observed disease progression or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.|Measured from first response until Disease Progression or death from any cause up to 2 years|There are no data recordings for this study. The study was terminated and the investigator is no longer related to the site. There is no additional information to provide.||||||
2646550|NCT01702909|Primary|Number of Participants With Response Using RECIST Criteria|Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2).|Measured until Disease Progression or death from any cause up to 2 year|No data was collected||||||
2646551|NCT01702896|Secondary|Median Survival|Measured from date of entry on study until date of death|From time of study entry until death, up to 10 years|Data was not collected||||||
2646552|NCT01702896|Secondary|Median Duration of Response|Duration of response is calculated as the time (months) from the date at which response is first observed (per standard Response Evaluation Criteria In Solid Tumors [RECIST] to the date of first observed disease progression or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.|Measured until Disease Progression or death from any cause up to 2 years|Data not collected||||||
2646553|NCT01702896|Primary|Response Rate|Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2).|Measured until Disease Progression or death from any cause up to 2 years|Data not collected||||||
2646554|NCT01702558|Secondary|Phase 1 (LA/mGC): t1/2 of 5-Fluorouracil (Metabolite of Capecitabine)|5-fluorouracil is a metabolite of capecitabine. Plasma terminal half-life is the time measured for the plasma drug concentration to decrease by one half during the elimination phase of the drug. t1/2 for 5-fluorouracil was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.|Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1|Analysis was performed on Phase 1 PK analysis population for LA/mGC cohort.|||hours||Standard Deviation|Mean
2646555|NCT01702558|Secondary|Phase 1 (LA/mGC): AUC(0-inf) of 5-Fluorouracil (Metabolite of Capecitabine)|5-fluorouracil is a metabolite of capecitabine. AUC(0-inf) is the measure of total drug exposure and is dependent on the total amount of drug absorbed. AUC(0-inf) for 5-fluorouracil was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.|Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1|Analysis was performed on Phase 1 PK analysis population for LA/mGC cohort.|||h*ng/mL||Standard Deviation|Mean
2646556|NCT01702558|Secondary|Phase 1 (LA/mGC): Cmax of 5-Fluorouracil (Metabolite of Capecitabine)|5-fluorouracil is a metabolite of capecitabine. Cmax for 5-fluorouracil was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.|Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1|Analysis was performed on Phase 1 PK analysis population for LA/mGC cohort.|||ng/mL||Standard Deviation|Mean
2646557|NCT01702558|Secondary|Phase 1 (LA/mGC): t1/2 of Capecitabine|Plasma terminal half-life is the time measured for the plasma drug concentration to decrease by one half during the elimination phase of the drug. t1/2 for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.|Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1|Analysis was performed on Phase 1 PK analysis population for LA/mGC cohort.|||hours||Standard Deviation|Mean
2646559|NCT01702558|Secondary|Phase 1 (LA/mGC): Cmax of Capecitabine|Cmax for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.|Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1|Analysis was performed on Phase 1 PK analysis population for LA/mGC cohort.|||ng/mL||Standard Deviation|Mean
2646560|NCT01702558|Secondary|Phase 1 (LA/mGC): Serum Concentration of Trastuzumab|Trastuzumab was derived from trastuzumab emtansine.|Pre-trastuzumab emtansine dose (0 h) on Day 1 Cycle 2; 15-30 min after end of trastuzumab emtansine infusion (maximum infusion duration = 90 min) on Day 2 Cycle 1 and Day 1 Cycle 2 (cycle length=21 days)|Analysis was performed on Phase 1 PK analysis population for LA/mGC cohort.|||mcg/mL||Standard Deviation|Mean
2646561|NCT01702558|Secondary|Phase 1 (LA/mGC): Serum Concentration of Trastuzumab Emtansine||Pre-trastuzumab emtansine dose (0 h) on Day 1 Cycle 2; 15-30 min after end of trastuzumab emtansine infusion (maximum infusion duration = 90 min) on Day 2 Cycle 1 and Day 1 Cycle 2 (cycle length=21 days)|Analysis was performed on Phase 1 PK analysis population for LA/mGC cohort.|||mcg/mL||Standard Deviation|Mean
2646562|NCT01702558|Secondary|Phase 1 (LA/mGC): Percentage of Participants With BOR as Assessed by the Investigator According to RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. BOR in Phase 1 was defined as percentage of participants with a CR or PR. CR was defined as the disappearance of all TLs and non-TLs; SA reduction to <10 mm for nodal TLs/non-TLs; and no new lesions. PR was defined as >/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions.|Baseline until CR/PR, consent withdrawal, or study end whichever occurred first (up to approximately 1.5 years overall)|Analysis was performed on Phase 1 DLT-evaluable population for LA/mGC cohort.|||percentage of participants|||Number
2646563|NCT01702558|Secondary|Phase 2 (mBC): Overall Survival (OS)|OS was defined as the time (in months) from randomization until death from any cause. Participants who were alive at the time of data cut-off were censored on the date of the last follow-up assessment. Participants who were lost to follow-up were censored as having no event (alive) on the date of last contact. The median OS and 90% CI was estimated using Kaplan-Meier method, which use the patients at risk as denominator rather than the whole number of patients.|Baseline until death or study end whichever occurred first (up to approximately 2.5 years overall)|Analysis was performed on ITT Population.|||months||90% Confidence Interval|Median
2646564|NCT01702558|Secondary|Phase 2 (mBC): Percentage of Participants Who Died of Any Cause||Baseline until death or study end whichever occurred first (up to approximately 2.5 years overall)|Analysis was performed on ITT Population.|||percentage of participants|||Number
2646565|NCT01702558|Secondary|Phase 2 (mBC): Percentage of Participants With Clinical Benefit as Assessed by the Investigator According to RECIST v1.1|The clinical benefit was defined as a confirmed response of CR, PR, or stable disease (SD) that lasted for at least 6 months. Tumor response was assessed by the investigator according to RECIST v1.1. CR: the disappearance of all TLs and non-TLs; SA reduction to <10 mm for nodal TLs/non-TLs; and no new lesions. PR: >/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions. PD: >/=20% relative increase with >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SoD on study. The 90% CI was computed using Clopper-Pearson approach.|Baseline until clinical benefit response, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)|Analysis was performed on ITT Population.|||percentage of participants||90% Confidence Interval|Number
2646566|NCT01702558|Secondary|Phase 2 (mBC): Progression-Free Survival (PFS) as Assessed by the Investigator According to RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. PFS was defined as the time (in months) from randomization until the first documented PD or death from any cause, whichever occurred first. PD was defined as >/=20% relative increase with >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. Participants with no PFS events were censored on the date of the last tumor assessment. Participants without post-baseline tumor assessment were censored at randomization plus 1 day. The median PFS and 90% CI was estimated using Kaplan-Meier method.|Baseline until PD, death from any cause, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)|Analysis was performed on ITT Population.|||months||90% Confidence Interval|Median
2646567|NCT01702558|Secondary|Phase 2 (mBC): Percentage of Participants With PD as Assessed by the Investigator According to RECIST v1.1 or Death From Any Cause|Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as >/=20% relative increase with >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs.|Baseline until PD, death from any cause, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)|Analysis was performed on ITT Population.|||percentage of participants|||Number
2646568|NCT01702558|Secondary|Phase 2 (mBC): Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST v1.1|TTF was defined as the time (in months) from randomization until treatment failure (PD, death, withdrawal due to AE or laboratory abnormality, or refusal of treatment). PD as assessed by the investigator according to RECIST v1.1 was defined as >/=20% relative increase with >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. Participants who did not experience any of the above events while on study were censored on the date of their last tumor assessment. The median TTF and 90% CI was estimated using Kaplan-Meier method.|Baseline until treatment failure, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)|Analysis was performed on ITT Population.|||months||90% Confidence Interval|Median
2646641|NCT01702428|Secondary|Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups|Antibody concentrations were expressed as GMCs in microgram/Milliliter (µg/mL).|At Day 42|ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||µg/mL||95% Confidence Interval|Geometric Mean
2646569|NCT01702558|Secondary|Phase 2 (mBC): Percentage of Participants With Treatment Failure as Assessed by the Investigator According to RECIST v1.1|Treatment failure was defined as occurrence of any of the following event while on treatment: PD, death, withdrawal due to adverse event (AE) or laboratory abnormality, or refusal of treatment. PD as assessed by the investigator according to RECIST v1.1 was defined as >/=20% relative increase with >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs.|Baseline until treatment failure, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)|Analysis was performed on ITT Population.|||percentage of participants|||Number
2646570|NCT01702558|Secondary|Phase 2 (mBC): Time to Progression (TTP) as Assessed by the Investigator According to RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. TTP was defined as the time (in months) from randomization to the first occurrence of PD. PD was defined as >/=20% relative increase with >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. Participants with no documented PD at the time of study end (including participants who died before PD) or who were lost to follow-up were censored on the date of the last tumor assessment. The median TTP and 90% CI was estimated using Kaplan-Meier method.|Baseline until PD, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)|Analysis was performed on ITT Population.|||months||90% Confidence Interval|Median
2646571|NCT01702558|Secondary|Phase 2 (mBC): Percentage of Participants With PD as Assessed by the Investigator According to RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. PD was defined as >/=20% relative increase with >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs.|Baseline until PD, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)|Analysis was performed on ITT Population.|||percentage of participants|||Number
2646572|NCT01702558|Secondary|Phase 2 (mBC): Duration of Response (DoR) as Assessed by the Investigator According to RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. DoR was defined as the time (in months) from the date of first recorded PR/CR until the date of PD or death from any cause. CR: the disappearance of all TLs and non-TLs; SA reduction to <10 mm for nodal TLs/non-TLs; and no new lesions. PR: >/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions. PD: >/=20% relative increase with >/=5 mm of absolute increase in the SoD, taking as reference the smallest SoD recorded since treatment started; 1 or more new lesion(s); and/or unequivocal progression of non-TLs. Participants with no documented PD after CR/PR were censored at the time of last tumor assessment. Participants without post-baseline tumor assessment were censored at randomization plus 1 day. The median DOR and 90% CI were estimated using Kaplan-Meier method.|From the documentation of response until PD, death, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)|Analysis was performed on ITT Population. Only participants with a BOR of CR or PR were included in the analysis.|||months||90% Confidence Interval|Median
2646573|NCT01702558|Secondary|Phase 2 (mBC): Time to Response (TTR) as Assessed by the Investigator According to RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. TTR was defined as the time (in months) from randomization to first documentation of confirmed PR or CR (whichever occurred first). CR was defined as the disappearance of all TLs and non-TLs; SA reduction to <10 mm for nodal TLs/non-TLs; and no new lesions. PR was defined as >/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions.|Baseline until first documentation of confirmed PR or CR, whichever occurred first (up to approximately 2.5 years overall)|Analysis was performed on ITT Population. Only participants with a BOR of CR or PR were included in the analysis.|||months||Full Range|Median
2646574|NCT01702558|Secondary|Phase 1 (mBC): t1/2 of 5-Fluorouracil (Metabolite of Capecitabine)|5-fluorouracil is a metabolite of capecitabine. Plasma terminal half-life is the time measured for the plasma drug concentration to decrease by one half during the elimination phase of the drug. t1/2 for 5-fluorouracil was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.|Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1|Analysis was performed on Phase 1 PK analysis population for mBC cohort. The PK analysis in the mBC cohort included 1 patient who was excluded from the main safety and efficacy analyses due to ICF issues.|||hours||Standard Deviation|Mean
2646575|NCT01702558|Secondary|Phase 1 (mBC): AUC(0-inf) of 5-Fluorouracil (Metabolite of Capecitabine)|5-fluorouracil is a metabolite of capecitabine. AUC(0-inf) is the measure of total drug exposure and is dependent on the total amount of drug absorbed. AUC(0-inf) for 5-fluorouracil was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.|Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1|Analysis was performed on Phase 1 PK analysis population for mBC cohort. The PK analysis in the mBC cohort included 1 patient who was excluded from the main safety and efficacy analyses due to ICF issues.|||h*ng/mL||Standard Deviation|Mean
2646576|NCT01702558|Secondary|Phase 1 (mBC): Cmax of 5-Fluorouracil (Metabolite of Capecitabine)|5-fluorouracil is a metabolite of capecitabine. Cmax for 5-fluorouracil was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.|Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1|Analysis was performed on Phase 1 PK analysis population for mBC cohort. The PK analysis in the mBC cohort included 1 patient who was excluded from the main safety and efficacy analyses due to ICF issues.|||ng/mL||Standard Deviation|Mean
2646577|NCT01702558|Secondary|Phase 1 (mBC): Plasma Terminal Half-Life (t1/2) of Capecitabine|Plasma terminal half-life is the time measured for the plasma drug concentration to decrease by one half during the elimination phase of the drug. t1/2 for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.|Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1|Analysis was performed on Phase 1 PK analysis population for mBC cohort. The PK analysis in the mBC cohort included 1 patient who was excluded from the main safety and efficacy analyses due to ICF issues.|||hours||Standard Deviation|Mean
2646578|NCT01702558|Secondary|Phase 1 (mBC): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC[0-inf]) of Capecitabine|AUC(0-inf) is the measure of total drug exposure and is dependent on the total amount of drug absorbed. AUC(0-inf) for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.|Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1|Analysis was performed on Phase 1 PK analysis population for mBC cohort. The PK analysis in the mBC cohort included 1 patient who was excluded from the main safety and efficacy analyses due to ICF issues.|||hours*nanograms per milliliter (h*ng/mL)||Standard Deviation|Mean
2646579|NCT01702558|Secondary|Phase 1 (mBC): Maximum Observed Plasma Concentration (Cmax) of Capecitabine|Cmax for Capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for percent coefficient of variation (CV%) and not for standard deviation.|Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1|Analysis was performed on Phase 1 PK analysis population for mBC cohort. The PK analysis in the mBC cohort included 1 patient who was excluded from the main safety and efficacy analyses due to ICF issues.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2646580|NCT01702558|Secondary|Phase 1 (mBC): Serum Concentration of Trastuzumab|Trastuzumab was derived from trastuzumab emtansine.|Pre-trastuzumab emtansine dose (0 h) on Day 1 Cycle 2; 15-30 min after end of trastuzumab emtansine infusion (maximum infusion duration = 90 min) on Day 2 Cycle 1 and Day 1 Cycle 2 (cycle length=21 days)|Analysis was performed on Phase 1 PK analysis population for mBC cohort. The PK analysis in the mBC cohort included 1 patient who was excluded from the main safety and efficacy analyses due to ICF issues.|||mcg/mL||Standard Deviation|Mean
2646581|NCT01702558|Secondary|Phase 1 (mBC): Serum Concentration of Trastuzumab Emtansine||Pre-trastuzumab emtansine dose (0 hour [h]) on Day 1 Cycle 2; 15-30 minutes (min) after end of trastuzumab emtansine infusion (maximum infusion duration = 90 min) on Day 2 Cycle 1 and Day 1 Cycle 2 (cycle length=21 days)|Phase 1 pharmacokinetic (PK) analysis population for mBC cohort; included all mBC participants receiving at least one dose of study medication during Phase 1 and had at least one reported serum/plasma result for PK. The PK analysis in mBC cohort included 1 patient who was excluded from the main safety and efficacy analyses due to ICF issues.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
2646582|NCT01702558|Secondary|Phase 1 (mBC): Percentage of Participants With BOR as Assessed by the Investigator According to RECIST v1.1|Tumor response was assessed by the investigator according to RECIST v1.1. BOR in Phase 1 was defined as percentage of participants with a CR or PR. CR was defined as the disappearance of all TLs and non-TLs; SA reduction to <10 mm for nodal TLs/non-TLs; and no new lesions. PR was defined as >/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions.|Baseline until CR/PR, consent withdrawal, or study end whichever occurred first (up to approximately 3.5 years overall)|Analysis was performed on Phase 1 DLT-evaluable population for mBC cohort.|||percentage of participants|||Number
2646583|NCT01702558|Primary|Phase 1 (LA/mGC): MTD of Capecitabine When Combined With Trastuzumab Emtansine (2.4 mg/kg QW)|MTD was defined as the dose level for which the probability of DLT is equal to a protocol-specified target probability. A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting >7 consecutive days; febrile neutropenia with ANC <1000 cells/mm^3; Grade >/=3 diarrhea or Grade 3 hand-foot syndrome; any other Grade >/=3 toxicity prohibiting start of Cycle 2; Grade 2 toxicity requiring treatment interruption for >14 days; <14 full doses of capecitabine; Cycle 2 dose level <100%.|Continuously during 3 weeks|Analysis was performed on Phase 1 DLT-evaluable population for LA/mGC cohort.|||mg/m^2|||Number
2646584|NCT01702558|Primary|Phase 1 (LA/mGC): Percentage of Participants With DLTs|A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting >7 consecutive days; febrile neutropenia with ANC <1000 cells/mm^3; Grade >/=3 diarrhea or Grade 3 hand-foot syndrome; any other Grade >/=3 toxicity prohibiting start of Cycle 2; Grade 2 toxicity requiring treatment interruption for >14 days; <14 full doses of capecitabine; Cycle 2 dose level <100%.|Continuously during 3 weeks|Analysis was performed on Phase 1 DLT-evaluable population for LA/mGC cohort, which included all enrolled and treated LA/mGC participants who did not experience any major protocol deviation and completed Cycle 1.|||percentage of participants|||Number
2646585|NCT01702558|Primary|Phase 2 (mBC): Percentage of Participants With Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|Tumor response was assessed by the investigator according to RECIST v1.1. BOR was defined as percentage of participants with a complete response (CR) or partial response (PR) that was confirmed by repeat assessments >/=4 weeks after initial documentation. CR was defined as the disappearance of all target lesions (TLs) and non-TLs; short axis (SA) reduction to <10 millimeters (mm) for nodal TLs/non-TLs; and no new lesions. PR was defined as >/=30% decrease in sum of diameters (SoD) of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions. The 90% confidence Interval (CI) was computed using Clopper-Pearson approach.|Baseline until CR/PR, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)|Analysis was performed on Intent-to-Treat (ITT) Population, which included all participants in the randomized Phase 2 part of the study. Participants were analyzed as per the initial randomization. Participants without tumor assessment after start of study treatment were considered as non-responders.|||percentage of participants||90% Confidence Interval|Number
2646602|NCT01702454|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Solicited local AEs assessed were pain, redness and swelling. Any = any solicited local AE reported irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).|During a 7-day (Day 0 to 6) follow-up period after first vaccination|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Subjects|||Number
2647015|NCT01699022|Primary|Tmax|Mean serum concentrations of E2 peaked by 3.3 days (range 1 - 7 days) following the third monthly injection|"Day 85"|Tmax|||day||Standard Deviation|Mean
2646586|NCT01702558|Primary|Phase 1 (mBC): Maximum Tolerated Dose (MTD) of Capecitabine When Combined With Trastuzumab Emtansine (3.6 mg/kg Every 3 Weeks)|MTD was defined as the dose level for which the probability of DLT is equal to a protocol-specified target probability. A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting >7 consecutive days; febrile neutropenia with ANC <1000 cells/mm^3; Grade >/=3 diarrhea or Grade 3 hand-foot syndrome (in absence of DPD deficiency only for DL 1); any other Grade >/=3 toxicity prohibiting start of Cycle 2; Grade 2 toxicity requiring treatment interruption for >14 days (>7 days for DL 1); for DL -1 only: <14 full doses of capecitabine; Cycle 2 dose level <100%.|Continuously during Cycle 1 (up to 3 weeks)|Analysis was performed on Phase 1 DLT-evaluable population for mBC cohort.|||mg/m^2|||Number
2646587|NCT01702558|Primary|Phase 1 (mBC): Percentage of Participants With Dose-Limiting Toxicities (DLTs)|A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting more than (>) 7 consecutive days; febrile neutropenia with absolute neutrophil count (ANC) less than (<) 1000 cells/millimeter cube (mm^3); Grade greater than or equal to (>/=) 3 diarrhea or Grade 3 hand-foot syndrome (in absence of dihydropyrimidine dehydrogenase [DPD] deficiency only for DL 1); any other Grade >/=3 toxicity prohibiting start of Cycle 2; Grade 2 toxicity requiring treatment interruption for >14 days (>7 days for DL 1); for DL -1 only: <14 full doses of capecitabine; Cycle 2 dose level <100 percent (%).|Continuously during Cycle 1 (up to 3 weeks)|Analysis was performed on Phase 1 DLT-evaluable population for mBC cohort, which included all enrolled and treated mBC participants who did not experience any major protocol deviation and completed Cycle 1.|||percentage of participants|||Number
2646588|NCT01702532|Secondary|The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes|"Participants completed a cigarette craving assessment consisting of the following five items: I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 mm VAS ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as the craving score for each time ."|Pre-dosing post-provocation to 3, 5, 7, 10, 15, 20, 25, and 30 minutes||||mm||95% Confidence Interval|Least Squares Mean
2646589|NCT01702532|Primary|The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds|"Participants completed a cigarette craving assessment consisting of the following five items: I have a desire for a cigarette right now; If it were possible I would smoke right now; All I want right now is a cigarette; I have an urge for a cigarette; I crave a cigarette right now. All participants indicated craving intensity on a pre-drawn 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as craving score for each time point."|Pre-dosing post-provocation to 50 seconds|All randomized participants who took at least one dose of medication and provided at least one valid craving assessment measurement on-treatment. Any participant with a missing response to any of the five craving assessment items was considered as a missing value and was imputed.|||mm||Inter-Quartile Range|Least Squares Mean
2646590|NCT01702519|Secondary|Rate of Elimination (Kel)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Elimination rate constant for nicotine was determined from plasma concentration time profiles. Blood samples were drawn at several time points: immediately pre-dose, and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours the application of the patch. Patch was then removed after the collection of 24 hour blood sample. Elimination rate constant for nicotine was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per protocol population, which included all randomized participants who took at least one dose of the study medications, had no protocol violations, and whose data was considered evaluable by the pharmacokineticist.|||1/hr||Full Range|Median
2646591|NCT01702519|Secondary|Plasma Half-life (t1/2)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. The elimination half-life of nicotine was determined by from plasma concentration time profiles. Blood samples were drawn at several time points: immediately pre-dose, and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after the application of the patch. Patch was then removed after the collection of 24 hour blood sample. Plasma half-life (t1/2) was based on the baseline adjusted nicotine plasma concentration data|Baseline to 32 hours|Per-prorocol population, which included all randomized participants who received at least one dose of the study treatment, had no protocol violation, and whose data was considered evaluable by the pharmacokineticist.|||Hrs||Full Range|Median
2646592|NCT01702519|Secondary|Time to Maximum Plasma Concentration (Tmax)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Time to Maximum Plasma Concentration was determined from plasma concentration time profiles. Blood samples were drawn at various time points; immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after application of the patch. Patch was then removed after the collection of 24 hour blood sample. Tmax was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per protocol population, which included all randomized participants who took at least one dose of the drug, did not have any protocol deviations and whose data was considered evaluable by the pharmacokineticist.|||hrs||Full Range|Median
2646610|NCT01702454|Secondary|Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.|VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Subjects|||Number
2646593|NCT01702519|Secondary|Area Under the Concentration Time Curve Between Zero and Infinity, AUC (0-inf)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Area under the plasma nicotine concentration time curve from zero extrapolated to infinity was determined by plasma concentration time profile of nicotine. Blood samples drawn at various time points including: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after wearing the patch. Patch was then removed after the collection of 24 hour blood sample. AUC(0 -inf) was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per Protocol Population, which consisted of all randomized participants who took at least one dose of the study treatment, did not have any protocol deviation, and provided enough pharmacokinetic data as determined by the pharmacokineticist.|||ng*h/mL||Standard Deviation|Mean
2646594|NCT01702519|Primary|Maximum Measured Plasma Concentration (Cmax)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Maximum plasma nicotine concentration was determined from plasma concentration time profiles. Blood samples were drawn at various time points: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after application the patch. Patch was then removed after the collection of 24 hour blood sample. Cmax was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per Protocol Population, which consisted of all randomized participants who took at least one dose of the study treatment, did not have any protocol deviation, and provided enough pharmacokinetic data as determined by the pharmacokineticist.|||ng/mL||Standard Deviation|Mean
2646595|NCT01702519|Primary|Area Under the Curve From Time 0 to the Last Quantifiable Sample, AUC(0-t)|Following randomization, the nicotine patches; reference nicotine patch or test nicotine patch (as per the assigned sequence), were applied on participant's upper back or arm. Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined by plasma concentration time profile of nicotine. Blood samples were drawn at the following time intervals: immediately pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 25, 26, 28, and 32 hours after the application of the patch. Patch was then removed after the collection of 24 hour blood sample. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.|Baseline to 32 hours|Per Protocol Population, which consisted of all randomized participants who took at least one dose of the study treatment, did not have any protocol deviation, and provided enough pharmacokinetic data as determined by the pharmacokineticist.|||nanogram (ng)*hour (hr)/milliliter (mL)||Standard Deviation|Mean
2646596|NCT01702454|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 - Day 179)|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
2646597|NCT01702454|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|Within 28 days (Days 0-27) after first vaccination|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
2646598|NCT01702454|Secondary|Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)|pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. Any pIMDs= Any AEs that occured regardless of the relation with vaccination. Related pIMDs= Any pIMD assessed by the investigator as casually related to the study vaccination.|During the entire study period (Days 0 - 179)|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
2646599|NCT01702454|Secondary|Number of Subjects Reporting AEs With Medically Attended Visits (MAV)|MAVs were defined as an AEs with a medically-attended visits i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was a MAV that prevented normal activities and related was defined as a MAV assessed by the investigator to be causally related to the study vaccination.|During the entire study period (Day 0 - Day 179)|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Subjects|||Number
2646600|NCT01702454|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were drowsiness, Irritability/Fussiness, loss of appetite and Temperature. Any Temperature = axillary temperature ≥37.5 degrees Celsius (°C). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = did not eat at all. Grade 3 temperature = axillary temperature > 39.0°C.|During the 7 days (Days 0 - 6) post dose 1 vaccination|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed.|||Subjects|||Number
2646601|NCT01702454|Secondary|Duration of Solicted Symptoms|Duration was defined as number of days with any grade of solicted local and/or general symptoms|During the 7-day (Days 0-6) post-vaccination Dose 1 period|Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.|||Days||Full Range|Median
2647016|NCT01699022|Primary|E2 Pharmacokinetics|AUC 0-28, AUC(0-inf)|Day 28||||pg.day/mL||Standard Deviation|Mean
2646603|NCT01702454|Secondary|MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.|MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.|At Day 7 post dose 1|Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available|||Fold Increase||95% Confidence Interval|Geometric Mean
2646604|NCT01702454|Secondary|Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.|VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria /361/2011(H3N2), B/Brisbane /60/2008(Victoria ) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.|At Day 7 post dose 1|Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2646605|NCT01702454|Secondary|MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata|MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0.The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.|At Day 7 post dose 1|Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available.|||Fold Increase||95% Confidence Interval|Geometric Mean
2646606|NCT01702454|Secondary|Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata|VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008(Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.|At Day 7 post dose 1|Analyses were perfomed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available|||Subjects|||Number
2646607|NCT01702454|Secondary|Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata|Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010(H1N1), A/Victoria/361/2011(H3N2),B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009(Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.|At Day 0 and Day 7|Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2646608|NCT01702454|Secondary|Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.|Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010 (H1N1),A/Victoria/361/2011 (H3N2), A/Victoria/361/2011 and B/Hubei-Wujiagang/158/2009)(Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available|||Titers||95% Confidence Interval|Geometric Mean
2646609|NCT01702454|Secondary|MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Fold increase||95% Confidence Interval|Geometric Mean
2646681|NCT01702311|Secondary|Mean Daily BG|Secondary outcomes include differences between treatment groups in any of the following measures: mean daily BG|participants will be followed for the duration of hospital stay, an expected average of 6 days||||mmol/L||Standard Deviation|Mean
2646611|NCT01702454|Secondary|MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Fold Increase||95% Confidence Interval|Geometric Mean
2646612|NCT01702454|Secondary|Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains|VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Subjects|||Number
2646613|NCT01702454|Secondary|Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|NI (Neuraminidase inhibitor) antibody titers were expressed as geometric mean titers(GMTs).The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Titer||95% Confidence Interval|Geometric Mean
2646614|NCT01702454|Secondary|Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|MN antibody titers were expressed as geometric mean titers(GMTs). The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Titer||95% Confidence Interval|Geometric Mean
2646615|NCT01702454|Secondary|Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|The cut-off values assessed were less than (<) 1:10, 1:10 to < 1:40,≥ 1:40, ≥1:60 and ≥1:80 . The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Subjects|||Number
2646616|NCT01702454|Secondary|MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2646617|NCT01702454|Secondary|Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.|VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2646618|NCT01702454|Secondary|MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2646619|NCT01702454|Secondary|Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.|VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2646620|NCT01702454|Secondary|Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|Antibody titers were expressed as GMTs. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Titer||95% Confidence Interval|Geometric Mean
2646621|NCT01702454|Secondary|Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Titer||95% Confidence Interval|Geometric Mean
2646622|NCT01702454|Secondary|Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|The cut-off values assessed were less than (<) 1:10, 1:10 to < 1:40 and ≥ 1:40. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2646623|NCT01702454|Primary|Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|Seroprotection rate was defined as the number of vaccinees with a serum HI titer greater than or equal to(≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Subjects|||Number
2646624|NCT01702454|Primary|Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|Mean geometric increase was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Fold Increase||95% Confidence Interval|Geometric Mean
2646625|NCT01702454|Primary|Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata )antigens.|At Day 7 post dose 1|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Subjects|||Number
2646626|NCT01702454|Primary|Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine|Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Subjects|||Number
2646627|NCT01702454|Primary|Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.|||Titers||95% Confidence Interval|Geometric Mean
2646628|NCT01702454|Primary|Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2648980|NCT01681121|Secondary|Evaluate the Change From Baseline in Epworth Sleepiness Scale Scores for ADX-N05 vs. Placebo at Last Assessment||12 weeks|||||||
2646629|NCT01702454|Primary|Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2646630|NCT01702454|Primary|Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 7 post dose 1|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2646631|NCT01702454|Primary|Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2646632|NCT01702454|Primary|Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine|Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.|At Day 0 and Day 7|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.|||Titer||95% Confidence Interval|Geometric Mean
2646633|NCT01702428|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity. Any SAE = Occurrence of SAE regardless of intensity grade or relation to vaccination.|From Day 0 through the end of study (Day 180)|TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented|||Participants|||Count of Participants
2646634|NCT01702428|Secondary|Number of Subjects Reporting AEs of Specific Interest|AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.|From Day 0 through the end of study (Day 180)|TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented|||Participants|||Count of Participants
2646635|NCT01702428|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited adverse event (AE) was defined as any adverse event reported in addition to those solicited during the clinical study and also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 43-days (Days 0-42) post-vaccination period|TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented|||Participants|||Count of Participants
2646636|NCT01702428|Secondary|Number of Subjects Reporting Any MMR Specific Solicited AEs|Assessed MMR specific solicited AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 43-days (Days 0-42) post-vaccination period|TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented|||Participants|||Count of Participants
2646637|NCT01702428|Secondary|Number of Subjects Reporting Any Rash|Assessed were any localized or generalized rash, rash with fever, varicella-like rash, measles/rubella-like rash. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 43-days (Days 0-42) post-vaccination period|TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented|||Participants|||Count of Participants
2646638|NCT01702428|Secondary|Number of Subjects Reporting Any Fever|Any fever = Fever ≥ 38°C.|During the 43-days (Days 0-42) post-vaccination period|TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented|||Participants|||Count of Participants
2646639|NCT01702428|Secondary|Number of Subjects With Any Solicited General AEs|Assessed solicited general AEs were drowsiness, irritability and loss of appetite. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 15-days (Days 0-14) post-vaccination period|TVC included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented|||Participants|||Count of Participants
2646640|NCT01702428|Secondary|Number of Subjects With Any Solicited Local Adverse Events (AEs)|Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.|During the 4-days (Days 0-3) post-vaccination period|Total Vaccinated cohort (TVC) included all subjects with at least one vaccine administration of either INV_MMR or COM_MMR lots documented|||Participants|||Count of Participants
2647017|NCT01699022|Primary|E2 Concentrations|Mean serum E2 concentrations on Day 1, Day 29, Day 57 and Day 85|"Day 1, Day 29, Day 57' and ''Day 85"||||pg/mL||Standard Deviation|Mean
2646642|NCT01702428|Secondary|Anti-HAV Antibody Concentrations in US Sub-cohort of Pooled MMR Groups|Antibody concentrations were expressed as GMCs in mIU/mL.|At Day 42|ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||mIU/mL||95% Confidence Interval|Geometric Mean
2646643|NCT01702428|Secondary|Percentage of Subjects With an Anti-HAV Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups|Percentage of subjects with an Anti-HAV antibody concentration equal to or above 15 mIU/mL were reported.|At Day 42|ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||Percentage of subjects||95% Confidence Interval|Number
2646644|NCT01702428|Secondary|Anti-VZV Virus Antibody Concentration in US Sub-cohort of Pooled MMR Groups|Antibody concentrations were expressed as GMCs in mIU/mL.|At Day 42|ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||mIU/mL||95% Confidence Interval|Geometric Mean
2646645|NCT01702428|Secondary|Percentage of Subjects With an Anti-Varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups|Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥75 mIU/mL among subjects who were seronegative (antibody concentration <25 mIU/mL) before vaccination.|At Day 42|ATP cohort for immunogenicity included subjects from US sub-cohort who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||Percentage of subjects||95% Confidence Interval|Number
2646646|NCT01702428|Primary|Anti-rubella Virus Antibody Concentration in Pooled MMR Groups|Antibody concentrations were expressed as GMCs in IU/mL.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||IU/mL||95% Confidence Interval|Geometric Mean
2646647|NCT01702428|Primary|Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups|Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 IU/mL among subjects who were seronegative (antibody concentrations <4 IU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to rubella virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to rubella virus.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||Percentage of subjects||95% Confidence Interval|Number
2646648|NCT01702428|Primary|Anti-mumps Virus Antibody Concentration in Pooled MMR Groups|Antibody concentrations were expressed as GMCs in EU/mL.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||EU/mL||95% Confidence Interval|Geometric Mean
2646649|NCT01702428|Primary|Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups|Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 EU/mL among subjects who were seronegative (antibody concentrations <5 EU/mL) before vaccination.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||Percentage of subjects||95% Confidence Interval|Number
2646650|NCT01702428|Primary|Anti-measles Virus Antibody Concentrations in Pooled MMR Groups|Antibody concentrations were expressed as GMCs in mIU/mL.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||mIU/mL||95% Confidence Interval|Geometric Mean
2646651|NCT01702428|Primary|Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups|Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 mIU/mL among subjects who were seronegative (antibody concentration <150 mIU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to measles virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to measles virus.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||Percentage of subjects||95% Confidence Interval|Number
2646652|NCT01702428|Primary|Anti-rubella Virus Antibody Concentration|Antibody concentrations were expressed as GMCs in IU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||IU/mL||95% Confidence Interval|Geometric Mean
2646653|NCT01702428|Primary|Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 International Unit/Milliliter (IU/mL) among subjects who were seronegative (antibody concentrations <4 IU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||Percentage of subjects||95% Confidence Interval|Number
2646654|NCT01702428|Primary|Anti-mumps Virus Antibody Concentration|Antibody concentrations were expressed as GMCs in EU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||EU/mL||95% Confidence Interval|Geometric Mean
2646655|NCT01702428|Primary|Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 ELISA Unit/Milliliter (EU/mL) among subjects who were seronegative (antibody concentrations <5 EU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||Percentage of subjects||95% Confidence Interval|Number
2646656|NCT01702428|Primary|Anti-measles Virus Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.|At Day 42|ATP cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||mIU/mL||95% Confidence Interval|Geometric Mean
2646657|NCT01702428|Primary|Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 milli International Unit/Milliliter (mIU/mL) among subjects who were seronegative (antibody concentration <150 mIU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.|At Day 42|According to protocol (ATP) cohort for immunogenicity included subjects who received at least 1 MMR vaccine, were below the assay cut-off at pre-vaccination & with pre & post dose serology results available for at least 1 antigen of MMR, did not meet any elimination criteria up to Visit 2 blood sample & complied with post dose blood sample schedule|||Percentage of subjects||95% Confidence Interval|Number
2646658|NCT01702363|Secondary|Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points|A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. An abnormal and significant ECG finding includes the presence of a QT interval corrected for heart rate (QTc interval) >500 milliseconds (msec) or an uncorrected QT interval >600 msec, for participants with Bundle Branch Block QTc >530 msec based on an average QTc value of triplicate ECGs. The study investigator determined if the abnormal ECG finding was CS or NCS. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD and Week 52/WD Visits were conducted for participants who completed the Week 24 Visit or withdrew before Week 24 and completed the Week 52 Visit or withdrew before Week 52, respectively. The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24,Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
2646659|NCT01702363|Secondary|Change From BL in Heart Rate Throughout the Treatment Period|Heart rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.|BL (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters or at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||beats per minute||Standard Deviation|Mean
2646682|NCT01702311|Primary|Mean Fasting Blood Glucose|The primary outcome of the study is to compare differences in mean fasting blood glucose levels between patients receiving insulin supplements at bedtime compared to those without insulin supplementation.|up to 10 days||||mg/dL||Standard Deviation|Mean
2646723|NCT01701973|Primary|Aim 1: Percent Change From Baseline in Forearm Vascular Resistance|Forearm blood flow was determined by strain gauge plethysmography. Forearm vascular resistance was then calculated by dividing this into mean arterial pressure. The percent change from baseline was determined at each timepoint.|Percent change from baseline in forearm vascular resistance at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes||||percentage change from baseline||Standard Deviation|Mean
2646660|NCT01702363|Secondary|Change From BL in Blood Pressure Throughout the Treatment Period|Blood pressure measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.|BL(Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2646661|NCT01702363|Secondary|Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Millimoles per Liter (MMOL/L)||Standard Deviation|Mean
2646662|NCT01702363|Secondary|Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Micromoles per Liter (µM/L)||Standard Deviation|Mean
2646663|NCT01702363|Secondary|Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||International Units per Liter (IU/L)||Standard Deviation|Mean
2646664|NCT01702363|Secondary|Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2646665|NCT01702363|Secondary|Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Grams per Liter (G/L)||Standard Deviation|Mean
2646696|NCT01702246|Secondary|Change From Baseline in Total Cholesterol Level After Treatment With Simvastatin||Baseline and 3 months|change in baseline cholesterol level from baseline, after treatment with simvastatin|||mmol/L||Standard Deviation|Mean
2646666|NCT01702363|Secondary|Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||10^9 cells per Liter (GI/L)||Standard Deviation|Mean
2646667|NCT01702363|Secondary|Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD Visit (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD Visit (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).|BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percentage of cells in blood||Standard Deviation|Mean
2646668|NCT01702363|Primary|Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities).|From the first dose of study medication up to 52 weeks|ITT Population|||Participants|||Number
2646669|NCT01702363|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect, or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations.|From the first dose of study medication up to 52 weeks|Intent-to Treat (ITT) Population: All participants who received at least one dose of the study medication. For participants who withdrew from the study, all available data collected until the time of study discontinuation were included in the ITT analysis.|||Participants|||Number
2646670|NCT01702311|Secondary|Number of Subjects With BG > 300 mg/dL||Subjects will be followed over the hospital stay: expected 6 days||||participants|||Number
2646671|NCT01702311|Secondary|Number of BG Within Target|Number of glucose levels within target of 70-140 mg/dl|Participants will be followed over the hospital stay- expected 6 days.||||participants|||Number
2646672|NCT01702311|Secondary|Acute Renal Failure [Rise >50% of Baseline or Creatinine >2.5 mg/dl]|Acute renal failure [rise >50% of baseline or creatinine >2.5 mg/dl]|participants will be followed for the duration of hospital stay, an expected average of 6 days||||number of events|||Number
2646673|NCT01702311|Secondary|Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days|Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg|daily while in hospital for up to 10 days||||number of events|||Number
2646674|NCT01702311|Secondary|Bacteremia|Bacteremia with SIRS/Sepsis|participants will be followed for the duration of hospital stay, an expected average of 6 days||||number of events|||Number
2646675|NCT01702311|Secondary|Pneumonia|Pneumonia (CDC criteria)|participants will be followed for the duration of hospital stay, an expected average of 6 days||||number of events|||Number
2646676|NCT01702311|Secondary|Nosocomial Infections (CDC)|Nosocomial infections during hospital stay as per the CDC criteria|participants will be followed for the duration of hospital stay, an expected average of 6 days||||number of events|||Number
2646677|NCT01702311|Secondary|Hospital Mortality|Mortality is defined as death occurring during admission or during the hospital stay|participants will be followed for the duration of hospital stay, an expected average of 6 days||||number of events|||Number
2646678|NCT01702311|Secondary|Length of Hospital Stay|Length of hospitalization|participants will be followed for the duration of hospital stay, an expected average of 6 days||||days||Inter-Quartile Range|Median
2646679|NCT01702311|Secondary|Daily Dose of Insulin|Compare the daily dose of insulin used among both groups|participants will be followed for the duration of hospital stay, an expected average of 6 days||||units/day||Standard Deviation|Mean
2646680|NCT01702311|Secondary|Number of Hypoglycemia (BG < 70 mg/dl)|Secondary outcomes include the number of hypoglycemia (BG < 70 mg/dl) among both the groups.|participants will be followed for the duration of hospital stay, an expected average of 6 days||||number of events|||Number
2646683|NCT01702298|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)|Change from baseline in HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.|Baseline and Week 6|FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of HDL-C.|||Percent change||95% Confidence Interval|Least Squares Mean
2646684|NCT01702298|Secondary|Change From Baseline in Triglycerides (TG)|Change from baseline in TG was measured as a percent change from baseline at Week 6 (median and distribution free 95% confidence interval).|Baseline and Week 6|FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS.|||Percent change||95% Confidence Interval|Median
2646685|NCT01702298|Secondary|Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C)|Change from baseline in non-HDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.|Baseline and Week 6|FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of non-HDL-C.|||Percent change||95% Confidence Interval|Least Squares Mean
2646686|NCT01702298|Secondary|Change From Baseline in Total Cholesterol (TC)|Change from baseline in TC was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.|Baseline and Week 6|"FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements.~One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of TC."|||Percent change||95% Confidence Interval|Least Squares Mean
2646687|NCT01702298|Secondary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)|Change from baseline in LDL-C was measured as a percent change from baseline at Week 6 based on LDA model including percent change from baseline as response variable and term time.|Baseline and Week 6|FAS defined as all participants who took at least one dose of study medication and had both baseline and post-baseline measurements. One participant, who had no on-treatment data, was excluded from the FAS for the LDA analysis of LDL-C.|||Percent change||95% Confidence Interval|Least Squares Mean
2646688|NCT01702298|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|Participants who were discontinued from study drug due to an adverse event during the 6 weeks of treatment.|Up to 6 weeks|All participants treated population defined as all enrolled participants who received at least one dose of study treatment.|||Participants|||Number
2646689|NCT01702298|Primary|Percentage of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 8 weeks (including 14 days after final dose of study drug)|All participants treated population defined as all enrolled participants who received at least one dose of study treatment.|||Percentage of participants||95% Confidence Interval|Number
2646690|NCT01702298|Primary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG at Week 6 based on longitudinal data analysis (LDA) model including both baseline and post-baseline measurements as response variable and term time.|Baseline and Week 6|Full analysis set (FAS) defined as all participants who took at least one dose of study medication and had at least one baseline or post-baseline measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2646691|NCT01702259|Secondary|Patient Satisfaction With Study Outcome|"At completion of the treatment administration phase, the subject was asked to indicate how satisfied he or she was with any overall perceived change in the appearance of cellulite in his or her thighs and buttocks using the following five-point scale:~Very Satisfied Somewhat Satisfied Neither Satisfied nor Dissatisfied Not Very Satisfied Not at All Satisfied~Results are reported as the number of subjects who reported being 'Very Satisfied' or 'Somewhat Satisfied' with the study outcome."|2 Weeks||||participants|||Number
2646692|NCT01702259|Secondary|Change in Percent (%) Body Surface Area (BSA) Covered by Cellulite.|The % Total Body Surface Area (% TBSA) covered by cellulite was marked and quantified according to the Lund and Browder Chart and methodology. The Lund and Browder chart is widely considered the most accurate method of determining Body Surface Area (BSA). It consists of an anterior and posterior diagram of a patient that is divided into sections. The % TBSA is the sum of the marked areas. The % TBSA of the buttocks and bilateral thighs area, front and back combined, affected by cellulite was calculated according to the Lund and Browder Chart.|Baseline and 2 weeks|The number of subjects analyzed for % TBSA covered by cellulite is less than the total number enrolled as this measure was not recorded for all subjects.|||percentage of TBSA||Standard Deviation|Mean
2646693|NCT01702259|Secondary|Change in Body Weight|Body weight is measured in pounds (lbs) using a digital scale.|Baseline and 2 weeks||||pounds||Standard Deviation|Mean
2646694|NCT01702259|Secondary|Bilateral Upper Thigh Circumference Measurement|Circumference of the upper right and left thighs was recorded in inches (ins) using a flexible tape measure and the two measurements were summed, at baseline and 2 weeks. A decrease in bilateral upper thigh circumference measurements is positive in support of study success and an increase in bilateral circumference measurements is negative in support of study success.|Baseline and 2 weeks||||inches||Standard Deviation|Mean
2646695|NCT01702259|Primary|Number of Subjects That Met the Individual Success Criteria|The individual subject success was defined as a decrease of one or more stages on the Nurnberger-Muller Scale (NMS) from baseline to 2 weeks post-assessment for both of the right and left thighs. The NMS is a four-stage scale used as an industry standard to classify stage or degree of cellulite and to determine change in stage or degree of cellulite following treatment intervention. The NMS ranges from Stage 0 (no cellulite) to Stage III (worse cellulite). A decrease in NMS Stage indicates reduced appearance of cellulite and is positive for study success. An increase in NMS Stage indicates worsened appearance of cellulite and is negative for study success. Overall study success was defined as 35% more subjects in the test group than in the control group attaining individual subject success. Results are reported below as the number of subjects in each group that met the individual subject success criteria.|Baseline and 2 weeks||||participants|||Number
2647018|NCT01699022|Primary|MPA Pharmacokinetics T1/2||"Day 85"||||day||Standard Deviation|Mean
2646698|NCT01702246|Primary|Change in Frequency of Vaso-occlusive Pain Events, Before and After Treatment With Simvastatin|The effect of simvastatin treatment will be assessed by measuring the difference from baseline in the mean frequency (and intensity) of vaso-occlusive pain events, after treatment with simvastatin. Pain rate (proportion of pain days) was defined as the number of days reported with sickle cell disease-related pain divided by the number of daily pain diaries completed.|Baseline and 3 months||||proportion of pain days||Standard Deviation|Mean
2646699|NCT01702233|Secondary|Change From Baseline in DASH at Visit 7 (Day 105)|"The score from the questions answered on the DASH (Disaability of the Arm, Shoulder and Hand) questionnaire were evaluated on both shoulders at screening and on the The score consists of a basic questionnaire of 30 questions regarding the daily activities with the answer options from no difficulty (value 1) to unable (value 5).~The calculation is: ((sum of values of responses/number of responses)-1) X 25. Best possible result is 0, worst possible result is 100. The score may not be calculated if there are more than 3 missing answers.target shoulder at the later visits. Any changes between the score from baseline was used to evaluate efficacy"|Baseline vs. Day 105||||DASH score||Standard Deviation|Mean
2646700|NCT01702233|Secondary|Change From Baseline in DASH at Visit 5 (Day 22)|"The score from the questions answered on the DASH (Disaability of the Arm, Shoulder and Hand) questionnaire were evaluated on both shoulders at screening and on the target shoulder at the later visits. Any changes between the score from baseline was used to evaluate efficacy.~The score consists of a basic questionnaire of 30 questions regarding the daily activities with the answer options from no difficulty (value 1) to unable (value 5).~The calculation is: ((sum of values of responses/number of responses)-1) X 25. Best possible result is 0, worst possible result is 100. The score may not be calculated if there are more than 3 missing answers."|Baseline vs. Day 22||||DASH score||Standard Deviation|Mean
2646701|NCT01702233|Secondary|Painful Arc Test at Visit 5 (Day 22)|The amount of pain that disappeared by further abduction in the range between 60° and 120° was to be measured, with measurement of pain being positive/negative. The idea behind the test is the subacromial space in abduction becomes smaller, whereby compression of the rotator cuff and the subacromial bursa occurs (impingement test).|Baseline vs. day 22||||participants|||Number
2646702|NCT01702233|Secondary|Jobe Test at Visit 5 (Day 22) With Measurement of Weakness|This test looked for pain and weakness and was to be examined as active movement. Patients have to stand with shoulders in 90 degrees of abduction, 30 degrees of forward flexion and then internally rotating arm completely i.e., thumb pointing down. This was done to see if the patient was able to resist the clinician's attempts to depress the upper arm to look for muscle weakness.|Baseline vs. day 22||||participants|||Number
2646703|NCT01702233|Secondary|Jobe Test at Visit 5 (Day 15) With Measurement of Pain|This test looked for pain and weakness and was to be examined as active movement. Patients have to stand with shoulders in 90 degrees of abduction, 30 degrees of forward flexion and then internally rotating arm completely i.e., thumb pointing down. This was done to see if the patient was able to resist the clinician's attempts to depress the upper arm to look for muscle weakness.|Baseline vs. Day 22||||participants|||Number
2646704|NCT01702233|Secondary|Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Fortecortin|Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.|Baseline vs. Day 105||||degrees||Standard Deviation|Mean
2646705|NCT01702233|Secondary|Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22) Traumeel vs Fortecortin|Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.|Baseline vs. Day 22||||degrees||Standard Deviation|Mean
2646706|NCT01702233|Secondary|Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Placebo|Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.|Baseline vs. day 105||||degrees||Standard Deviation|Mean
2646707|NCT01702233|Secondary|Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22), Traumeel vs Placebo|Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.|Baseline vs. Day 22||||degrees||Standard Deviation|Mean
2646708|NCT01702233|Secondary|Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Fortecortin at Visit 7 (Day 105)|VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain).|Baseline vs. day 105||||units on a scale, mm||Standard Deviation|Mean
2646709|NCT01702233|Secondary|Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 7 (Day 105)|VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain).|Baseline vs. Day 105||||units on a scale, mm||Standard Deviation|Mean
2646710|NCT01702233|Secondary|Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 5 (Day 22)|VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain).|Baseline vs. Day 22||||Change in mm baseline vs. day 22||Standard Deviation|Mean
2646711|NCT01702233|Primary|Change From Baseline in Abduction Rotation Pain VAS at Visit 5 (Day 22) (Traumeel® S Injections Versus Fortecortin) for Active External Rotation|VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain). Change = (Day 22 score -- baseline score).|Baseline to Day 22|Per protocol population|||units on a scale (mm)||Standard Deviation|Mean
2646744|NCT01701401|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 8||Week 8|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2646745|NCT01701401|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 4||Week 4|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2646746|NCT01701401|Secondary|Percentage of Participants With HCV RNA < LLOQ at Week 2||Week 2|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2646712|NCT01702025|Primary|Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen).|After exercising on a stationary cycle ergometer for 30 minutes at a resistance of 100 watts, research participants will complete an exercise time trial. The time taken to cycle a distance equivalent to 7.75 miles will be recorded. On a separate day the experiment will be repeated in hypoxia. It is expected that the time taken to cycle a distance equivalent to 7.75 miles will be longer in hypoxia compared to normoxia. One of the goals of this research is to determine if the hypoxia-mediated performance decrement can be decreased with one of our pharmacological interventions.|The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia||||minutes||Standard Error|Mean
2646713|NCT01701999|Other Pre-specified|Collected Plasma Volume|Measurement of the volume of source plasma containing neutralizing antibodies against botulinum toxin type A and type B collected by plasmapheresis in Part 2.|Week 1 to Week 12|Participants in Part 1 were only analyzed for safety data, and one participant in Part 2 was excluded from plasma collection due to not meeting the plasma donor minimum weight requirement.|||mL||Standard Deviation|Mean
2646714|NCT01701999|Secondary|Two-Fold Increase in the Area Under the Neutralizing Antibody Concentration (NAC) Curve|Proportion of participants achieving a two-fold increase in the area under the plasma NAC-time curve between Week 0 and Week 12 in comparison with a straight-line extension of the Week 0 NAC to Week 12 for both botulinum toxin A and toxin B. A proportion ≥ 0.50 was considered a success.|Week 0 to Week 12||||proportion of participants|||Number
2646715|NCT01701999|Secondary|Three-Fold Increase in Neutralizing Antibody Concentration (NAC)|Proportion of participants achieving a three-fold or greater increase in NAC up to Week 4 compared with Week 0 for both botulinum toxin A and toxin B (a proportion ≥ 0.50 was considered a success)|Week 0 to Week 4||||proportion of participants|||Number
2646716|NCT01701999|Primary|Four-Fold Increase in Neutralizing Antibody Concentration (NAC)|Proportion of participants achieving a four-fold or greater increase in NAC up to Week 4 compared with Week 0 for both botulinum toxin A and toxin B (a proportion ≥ 0.50 was considered a success).|Week 0 to Week 4||||proportion of participants|||Number
2646717|NCT01701973|Secondary|Aim 2: Measurement of Growth Hormone (GH) Levels|Subjects undergo two study days separated by a washout period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized double-blind fashion. Growth hormone secretion following arginine stimulation was assessed at each visit. Growth hormone levels were determined using an assay that is not subject to interference by pegvisomant.|baseline and every 30 minutes until 180 minutes|Five of the original 29 women returned for an additional two study days separated by a wash-out period. As pre-specified in the protocol, men did not complete this portion of the study. We did not measure GH levels in participants who received LNMMA or Exendin 9-39 as these drugs are not known to influence GH secretion.|||ng/mL||Standard Error|Mean
2646718|NCT01701973|Secondary|Aim 2: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels|Subjects undergo two study days separated by a washout period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized double-blind fashion. Tissue plasminogen activator activity (tPA) was assessed at each visit.|baseline and every 30 minutes until 180 minutes|Five of the original 29 women returned for two more study days separated by a wash-out. As pre-specified in the protocol, men did not complete this portion of the study. We do not report tPA results from participants who received LNMMA and Exendin 9-39 in this table as the manufacturer changed the tPA assay standard and results were not comparable.|||IU/ml||Standard Error|Mean
2646719|NCT01701973|Secondary|Aim 1: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels|In Aim 1 subjects underwent two study days separated by a washout period. On one study day they received study drug and on another placebo, in a randomized double-blind fashion. Venous blood samples were obtained at each visit.|baseline and every 30 minutes for 180 minutes|Data from the first 14 subjects (7 men and 7 women) who completed both study days in Aim 1 were analyzed. We do not report tPA results from the remaining participants as the manufacturer changed the tPA assay standard and results were not comparable.|||IU/ml||Standard Error|Mean
2646720|NCT01701973|Primary|Aim 2: Percent Change From Baseline in Forearm Vascular Resistance|Subjects undergo two study days separated by a washout period. On one study day they will receive sitagliptin plus another study drug and on another sitagliptin plus placebo, in a randomized double-blind fashion. Forearm blood flow was assessed at each visit every 30 minutes for 3 hours. This was divided into mean arterial pressure to determine forearm vascular resistance.|Percent change from baseline in forearm vascular resistance at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes|19 of the original 29 females who participated in Aim 1 returned to complete an additional two study days (Aim 2) in which they received sitagliptin + double-blinded study drug vs. sitagliptin plus placebo in a cross-over study. Three men from Aim 1 also returned to complete two more study days (Aim 2).|||percent change from baseline||Standard Error|Mean
2646721|NCT01701973|Primary|Aim 2: Percent Change From Baseline in Forearm Blood Flow|Subjects undergo two study days separated by a washout period. On one study day they received sitagliptin plus another study drug and on another sitagliptin plus placebo, in a randomized double-blind fashion. Forearm blood flow was assessed at each visit.|Percent change from baseline in forearm blood flow at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes.|19 of the original 29 females in Aim 1 returned to complete two more study days (Aim 2) in which they received sitagliptin + double-blinded study drug vs. sitagliptin plus placebo in a cross-over study. Three men from Aim 1 also returned to complete two more study days (Aim 2).|||percent change from baseline||Standard Error|Mean
2646722|NCT01701973|Primary|Aim 1: Percent Change From Baseline in Forearm Blood Flow|Forearm blood flow was determined by strain gauge plethysmography. The percent change from baseline was determined at each timepoint.|Percent change from baseline in forearm blood flow at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes.|Data from all subjects who completed both study days in Aim 1 were analyzed. Subjects represented young, healthy adults without any chronic medical conditions and who did not take any medications. Oral birth control use was not permitted.|||percent change from baseline||Standard Deviation|Mean
2646747|NCT01701401|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug|SVR4 and SVR24 were defined as HCV RNA level < LLOQ at 4 and 24 weeks after discontinuation of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
2646724|NCT01701973|Primary|Aim 1: Stimulated Peak Growth Hormone Level|Subjects underwent two study days separated by a washout period. On one study day they will receive sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine (30 grams i.v. over 30 minutes) on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.|Growth Hormone Level at 30 minutes (i.e. at completion of arginine infusion), 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes|Data from all subjects who completed both study days in Aim 1 were analyzed. Subjects represented young, healthy adults without any chronic medical conditions and who did not take any medications. Oral birth control use was not permitted.|||ng/ml||Standard Deviation|Mean
2646725|NCT01701674|Secondary|Progression Free Survival (PFS)|Progression-free survival (PFS) per RECIST V1.1, defined as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve. Progressive Disease (PD): At least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum recorded since the treatment started or the appearance of one or more new lesions.|42 months|All participants.|||months||Full Range|Median
2646726|NCT01701674|Secondary|Overall Response Rate (ORR)|Overall Response: Complete Response (CR) + Partial Response (PR), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by computed tomography (CT) scan. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions..|12 weeks|All participants.|||percentage of participants|||Number
2646727|NCT01701674|Primary|Rate of Meeting Feasibility Requirements|Number of participants who were successfully treated with at least 2 doses of ipilimumab and received TIL. Feasibility is defined as the ability to deliver at least 50% (i.e., two out of four) of the planned doses of ipilimumab and successfully treat at least 60% (i.e., ≥ 6/10) of the patients with TIL.|3 months|All participants|||Participants|||Count of Participants
2646728|NCT01701674|Primary|Occurrence of Dose Limiting Toxicity (DLT) Events|Occurrence of adverse events with dose limiting toxicity, per adverse event category.|3 months|All participants|||DLT events|||Number
2646729|NCT01701622|Secondary|If Patients With Hypertension Receive a Greater Reduction in Blood Pressure (BP) While on Febuxostat (Versus Allopurinol)|measured by mean 24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and mean nighttime SBP/SBP while on allopurionol and febuxostat.|Participants will be followed for an expected average of 4 to 5 weeks.|||||||
2646730|NCT01701622|Primary|BP Differences While on Allopurinol and Febuxostat by Clinic Blood Pressure Readings and 24-hour Ambulatory Blood Pressure Readings|The data collected will be analyzed and categorized according to age, race, gender, weight, height, 24-hour ABPM (24-hour systolic blood pressure (SBP)/diastolic blood pressure (DBP), trough SBP/DBP, and the mean nighttime SBP/SBP). Clinic systolic and diastolic BP and 24-hour AMBPs will be compared between the two treatments.|4 to 5 weeks|no analysis, as only one participant||||||
2646731|NCT01701505|Secondary|Incidence of Adverse Events by Dose Level Regardless of Age||from baseline to 24 hours following drug administration||||Participants|||Count of Participants
2646732|NCT01701505|Secondary|Number of Participants With Adverse Events by Dose Level and Age||from baseline to 24 hours following drug administration|Patients grouped by age|||Participants|||Count of Participants
2646733|NCT01701505|Secondary|Oxygen Saturation||At Baseline, 12 minutes, and 120 minutes||||percent||Standard Deviation|Mean
2646734|NCT01701505|Secondary|Heart Rate||At Baseline, 12 minutes, and 120 minutes||||bpm||Standard Deviation|Mean
2646735|NCT01701505|Secondary|Diastolic Blood Pressure||At Baseline, 12 minutes, and 120 minutes||||mmHg||Standard Deviation|Mean
2646736|NCT01701505|Secondary|Systolic Blood Pressure||At Baseline, 12 minutes, and 120 minutes||||mmHg||Standard Deviation|Mean
2646737|NCT01701505|Secondary|Naris Examination (NE) to Assess Reactions to the Study Drug.|The principal investigator will perform a visual inspection to note number of participants at post-dose that have a ulceration, inflammation or minor bleeding.|At Baseline and 120 Minutes||||Participants|||Count of Participants
2646738|NCT01701505|Primary|Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.|If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.|at 14 minutes with a 3 minute window||||Participants|||Count of Participants
2646739|NCT01701414|Primary|Number of Participants Reporting at Least One NRS Rating|Participants report their discomfort using a Numerical Rating Scale (NRS). Pain level is reported as 0 (lowest-no pain) to 10 (highest level of pain). Each patient enrolled in the study reported their level of pain at least once during their participation in the study.|30 minutes after the block is administered then every 60 minutes until discharge. Desired outcome was a low NRS rating.||||Participants|||Number
2646740|NCT01701401|Secondary|Percentage of Participants With Virologic Failure|"On-treatment virologic failure was defined as:~Breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow- up values, OR~Rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value could have been posttreatment), or last available on-treatment measurement with no subsequent follow-up values, OR~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment~Virologic relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement"|Baseline to posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2646741|NCT01701401|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2646742|NCT01701401|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2646743|NCT01701401|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2646748|NCT01701401|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug|The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.|Up to 24 weeks|Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2646749|NCT01701401|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12)|SVR12 was defined as HCV RNA level < the lower limit of quantification (LLOQ, ie, < 25 copies/mL) 12 weeks after last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2646750|NCT01701375|Secondary|To Determine the Maximal Tolerated Dose (MTD) of PD 0332991 in Timed Sequential Combination With Ara-C and Mitoxantrone|Dose escalation decisions will be based on nonhematologic toxicities in Cycle 1 (28 days) and hematologic toxicities, in the case of an aplastic marrow through Day 56, For cytopenias including ANC < 500/mm3 or platelets < 50, 000/mm3 a bone marrow will be performed between days 42 and 49.. Dose limiting toxicity (DLT) will be measured according to NCI-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|42 days|||||||
2646751|NCT01701375|Primary|The Toxicities of Administration of PD 0332991 in Combination With Cytarabine and Mitoxantrone.|The number of participants experiencing toxicities of administration of PD 0332991 in combination with cytarabine and mitoxantrone will be measured according to NCI-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|42 days||||participants|||Number
2646752|NCT01701362|Secondary|Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50%|Participants with at least 50% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.|Week 15|ITT population: all randomized participants who took at least one dose of study drug|||Percentage of participants|||Number
2646753|NCT01701362|Secondary|Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%.|Participants with at least 30% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.|Week 15|ITT population: all randomized participants who took at least one dose of study drug|||Percentage of participants|||Number
2646754|NCT01701362|Secondary|Percentage of Participants in MOS-SS With Optimal Sleep Status.|MOS-SS optimal sleep status analyzed on a scale of four parameters: any improvements, no change, any worsening and not applicable.|Week 15|ITT population: all randomized subjects who took at least one dose of study drug|||Percentage of participants|||Number
2646755|NCT01701362|Secondary|Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.|"MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.~Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.~Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.~Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.~Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours."|Week 15|ITT population: all randomized participants who took at least one dose of study drug.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2646756|NCT01701362|Secondary|Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.|"MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.~Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.~Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.~Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.~Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours."|Baseline|ITT population: all randomized participants who took at least one dose of study drug.|||Units on a scale||Full Range|Median
2646757|NCT01701362|Secondary|Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores|A self-administered questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression. Each dimension is rated on a 3 point response scale and the scores are combined to form a single index value between 0 and 1 with higher scores being more positive (better health status). The EQ-5D was completed by the subject at week-0 and week-15/ET where 30% responder and 50% responder status would be defined for each participants based on the percent change from baseline (week 0/Randomization) to each visit week in mean pain score and participant global impression of change (PGIC). PGIC is a self-administered instrument that measures change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). It is based on the Clinical Global Impression of Change CGIC), which is a validated scale.|Week 15|ITT population: all randomized participants who took at least one dose of study drug|||Units on a scale||Standard Error|Least Squares Mean
2647019|NCT01699022|Primary|MPA Pharmacokinetics Tmax|Mean serum MPA concentrations peaked at 4.1 days (range 1 - 21 days) after the third monthly administration of Cyclofem.|"Day 85"||||day||Standard Deviation|Mean
2646758|NCT01701362|Secondary|Change From Baseline in Pain Interference Index (BPI-sf)|"BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation.~It consists of 7 sub-questions that evaluates the level of pain interference with daily functioning on 11-point response scales from 0 (does not interfere) to 10 (completely interferes).~The BPI-sf pain interference index was calculated as average of the seven individual pain interference scores."|Week 15|ITT population: all randomized participants who took at least one dose of study drug|||units on a scale||Standard Error|Least Squares Mean
2646759|NCT01701362|Secondary|Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])|A self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation. The BPI-sf consists of 5 questions. Four items measure pain on 11-point response scales from 0 (No Pain) to 10 (Pain as bad as you can imagine). In the above scale, score 0 indicates the better outcome whereas score 10 indicates the worse outcome.|Week 15|ITT population: all randomized participants who took at least one dose of study drug|||units on a scale||Standard Error|Least Squares Mean
2646760|NCT01701362|Secondary|Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)|"This is an 11-point NRS ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep [unable to sleep due to pain]). Participants describe how pain has interfered with their sleep during the past 24 hours. Please note that the data for Baseline (raw scores) have been included in the below table to read the change from Baseline data in context.~Note: Weekly mean SIRS scores were derived from the daily sleep diary and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean SIRS scores were defined as the mean of the 7 daily diary SIRS scores from Day 2+7 (n-1) to Day 1+7*n. For participants with multiple diary scores collected on the same day, the average of all non-missing scores for that day was used in any analyses or data listings.~Overall is the pooled average sleep interference score for each subject across all post-baseline/randomization weeks."|up to Week 15|ITT population: all randomized participants who took at least one dose of study drug|||units on a scale||Standard Deviation|Mean
2646761|NCT01701362|Secondary|Patient Global Impression of Change (PGIC) at Week 15|A self administered instrument that measures changes in participants' overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). The PGIC is based on the Clinical Global Impression of Change, which is a validated scale.|Week 15|ITT population: all randomized participants who took at least one dose of study drug|||Participants|||Number
2646762|NCT01701362|Primary|Change From Baseline to Week 15 in Weekly Mean Pain Score|"This is based on the daily pain diary and is defined as the change from baseline to week 15 in mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10."|up to Week 15|ITT population: all randomized participants who took at least one dose of study drug|||units on a scale||Standard Error|Least Squares Mean
2646763|NCT01701362|Primary|Baseline Mean Pain Score|"This is based on the daily pain dairy and is defined as the baseline mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10."|Baseline|Intent to Treat (ITT) population: all randomized participants who took at least one dose of study drug|||units on a scale||Standard Deviation|Mean
2646764|NCT01701271|Primary|Change of the Density of the Hair on a Polarized Light Video-camera as a Measure of Efficacy.|Number of hair was assessed for each participant with a polarized light video-camera every 15 days for a total of 6 assessments|baseline and 90 days|Good state of general health Suffering from hair loss No pharmacological treatment in progress Promise not to change the usual daily routine No atopy in the anamnesis|||hairs/square inch||Full Range|Mean
2646765|NCT01701271|Secondary|Change of Sebum on a Sebum-meter|Measurements checked and reported every 15 days of the decrease of existing sebum on the scalp of the volunteers with a sebum-meter.|baseline and 90 days|Good state of general health Suffering from hair loss|||mg sebum/c^2||Full Range|Mean
2646766|NCT01701271|Primary|Change of the Amount of Hair Loss in a Pull Test|"Measurement of the decrease of hair loss by pull test and pulling some hair with the fingers.~Measurements estimated and reported every 15 days. The Measure reports decrease in fallen hair"|baseline and 90 days|Good state of general health Suffering from hair loss No pharmacological treatment in progress Promise not to change the usual daily routine No atopy in the anamnesis|||Fallen hair||Full Range|Mean
2646767|NCT01701258|Primary|The Effect of Diagnosis on Cortisol Reactivity|"This is a measure of area under the curve in relation to ground, a measure of total cortisol output, in response to acute stress. The acute stressor was the Maastricht Acute Stress Test (MAST). The area under the curve includes all 5 cortisol measures, with one measure before the stressor and the other four measures collected after the stressor. Given that the cortisol data were positively skewed, the cortisol measures were normalized via a log transformation prior to calculating the area under the curve.~Area under the curve with respect to ground (AUCG) is calculated AUC_g=(((cort2_log + cort1_log) * cort_t1_time) / 2)+(((cort3_log+cort2_log)*cort_t2_time)/2)+(((cort4_log+cort3_log)*cort_t3_time)/2)+(((cort5_log+cort4_log)*cort_t4_time)/2). Cort_logs are the log transformed cortisol output data (ng/ml) and the cort_times are the time spans in between each cortisol assessment."|3 hour EEG Session (Session 4)||||[log (ng/ml)]*min||Standard Error|Mean
2646768|NCT01701258|Primary|Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Feedback|"This statistic shows the influence of major depressive disorder and childhood sexual abuse history on the strength of striatal activation (caudate, putamen, accumbens) in response to neutral and reward feedback during the monetary incentive delay task (MID).~Striatal activation is measured using a statistic called a beta weight. A beta weight is a standardized regression coefficient. Higher beta weights mean greater striatal activation and lower beta weights mean less striatal activation. A negative beta weight would indicate a deactivation."|3 hour Session 2 (fMRI session)||||beta weight (slope)||Standard Error|Mean
2646925|NCT01700140|Secondary|Time to First Emesis|Time from the start of radiotherapy to the onset of first emesis. The median (50% point) of time to first emesis was estimated.|24-72 hours|"Per protocol set:~Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."|||Hours||95% Confidence Interval|Median
2646769|NCT01701258|Primary|Effects on Major Depressive Disorder and Childhood Sexual Abuse History on Striatal Activity in Response to Neutral and Reward Cues|"This statistic shows the influence of major depressive disorder and childhood sexual abuse history on the strength of striatal activation (caudate, putamen, accumbens) in response to neutral and reward cues during the monetary incentive delay task (MID).~Striatal activation is measured using a statistic called a beta weight. A beta weight is a standardized regression coefficient. Higher beta weights mean greater striatal activation and lower beta weights mean less striatal activation. A negative beta weight would indicate a deactivation."|3 hour Drug & fMRI Session (Session 2)||||beta weight (slope)||Standard Error|Mean
2646770|NCT01701258|Primary|Cortisol Output in Response to a Stress Manipulation|This statistic shows the impact of the stress manipulation on the participant's salivary cortisol output. Saliva samples were collected at 5 distinct time points throughout the study session. The first saliva sample (Cort 1) was collected when the participant began the eeg session. The second (Cort 2)was taken at the end of the acute stressor. The third (Cort 3) was taken approximately fifteen minutes after the second. The fourth (Cort 4) was taken approximately ten minutes after the third. The fifth (Cort 5) was taken approximately 40 minutes after the fourth.|3 hour EEG Session (Session 4)||||ng/ml||Standard Error|Mean
2646771|NCT01701258|Primary|The Effect of Major Depressive Disorder and Childhood Abuse History on a Reward-related EEG Component (Reward Positivity Component) While Under Stress|"EEG was recorded during the probabilistic reward task (the PRT task). Participants completed the Probabilistic Reward Task (PRT) twice throughout the experiment, once before stress and once after stress. The stressor was the Maastricht Acute Stress Test (MAST). This statistic shows the effect that childhood sexual abuse (CSA) and diagnosis had on a reward-related positivity EEG component recorded during the PRT, before and after stress.~Higher reward positivity amplitudes indicate a stronger neural response to reward and lower amplitudes indicate a lower neural response to rewards."|3 hour EEG Session (Session 4)||||amplitude (microvolts)||Standard Error|Mean
2646772|NCT01701258|Primary|The Effects of CSA and Diagnosis on PRT Performance Under Acute Stress|The participant's performance on the Probabilistic Reward Task (PRT) was assessed both before and after an acute stressor. The PRT is a behavioral task that measures an individual's ability to learn from rewarding stimuli and incorporate this learning into their response style (response bias). The acute stressor was the Maastricht Acute Stress Test (MAST). The score obtained is a ratio of the number of times participants correctly choose the high reward stimuli versus the low rewarding stimuli. Response bias scores range between -1 and +1. Higher response bias scores indicate a stronger response bias toward high reward stimuli. A negative response bias indicates a stronger bias toward low reward stimuli.|3 hour EEG Session (Session 4)||||Ratio (Response Bias Score)||Standard Deviation|Mean
2646773|NCT01701258|Primary|Dopamine Active Transporter Binding Potential|"Utilizing 11C-altropane during positron emission tomography (PET) scanning allows us to measure dopamine active transporter (DAT) binding potential.~Our outcome measure is Nondisplacable Binding Potential (BPND). BPND refers to the ratio at equilibrium of specifically bound radioligand to that of nondisplaceable radioligand in tissue.~*Higher BPND scores indicate greater binding potential"|1 hour PET scan (Session 3)||||Ratio||Standard Error|Mean
2646774|NCT01701245|Secondary|EQ-5D-3L (EuroQoL 5 Questions and 3 Answering Levels) and a VAS (Visual Analogue Scale)|"The EQ-5D-3L (EuroQoL 5 questions and 3 answering levels) during the run-in period will be compared with the EQ-5D-3L during the treatment period. And treatment period will be compared to open label.~Rating of questions Level 1 no problems Level 2 some problems Level 3 Significant problems Worst case is 15 points and best case is 5 points using index~Visual analogue scale VAS 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state"|10 weeks (baseline 2 weeks, random 4 weeks and open label 4 weeks)|Changes between baseline and randomized period.Randomized period and open label. FAS Unmatched data.|||units on a scale||Full Range|Mean
2646775|NCT01701245|Secondary|Adverse Events|The frequency of device effects will be compared between the two treatment groups. Only effects which are new after baseline or have increased severity after baseline will be used in the comparison.|10 weeks|Safety population The Adverse Device effects are reported as Adverse Event, the device effects are AEs that are considered related to the treatment. Graded mild, moderate and severe|||participants|||Number
2646776|NCT01701245|Secondary|Pain Relief of Headache Attacks|"The median pain during baseline (2 weeks) will be compared with the last 14 days of the treatment period Scale 0-4 0= no pain~mild pain~moderate pain~severe pain~very severe pain"|baseline (2 weeks) and random period(last 2 weeks)|"Median severity per subject in run in period (14 days) and the last 14 Days in the treatment period.~FAS matched data set"|||participants|||Number
2646777|NCT01701245|Primary|A Change in the Frequency of Cluster Headache Attacks Per Week|The primary endpoint is the reduction in mean number of CH attacks per week. The number of CH attacks will be calculated as the sum of all attacks over the days in the run-in period and divided by the number of weeks, respectively for the last 14 days of treatment during the randomised phase. The reduction will then be the number of CH attacks during treatment period (last 14 days of the randomized treatment period) - number of CH attacks during run-in.|4 weeks|Full analysis set (FAS), matched group.|||CH attacks per week||Standard Deviation|Mean
2646778|NCT01701115|Secondary|Side Effects|Incidence of nausea|Postoperative Day 2||||Participants|||Count of Participants
2646779|NCT01701115|Secondary|Duration of Analgesia|Time to pain|Postoperative Day 2||||minutes||95% Confidence Interval|Median
2646780|NCT01701115|Secondary|Patient Readiness to Discharge||Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes)||||minutes||Standard Deviation|Mean
2646781|NCT01701115|Primary|Handgrip Strength|The primary outcome will be handgrip strength as measured by a dynamometer. A reading will be obtained at baseline (before the interscalene block) and 60 minutes post-operative.|Difference between between baseline and postoperative.||||kg||Standard Deviation|Mean
2646782|NCT01701102|Primary|Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)|The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery|Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours.||||minutes||Inter-Quartile Range|Median
2648981|NCT01681121|Secondary|Evaluate the Change From Baseline in Epworth Sleepiness Scale Scores for ADX-N05 vs. Placebo at Week 4||4 weeks|||||||
2646783|NCT01701063|Secondary|Elimination Half-Life (T1/2) of Telaprevir|T1/2 was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half.|Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7|Half life was not calculated because the calculation required the slope of terminal elimination phase and the PK sampling was relatively sparse and did not yield a terminal elimination phase from which half-life can be accurately estimated.||||||
2646784|NCT01701063|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of Telaprevir|AUC was measured for telaprevir only. AUC 0-t last was defined as the area under the concentration-time curve from the time of dosing to the last measurable concentration. AUC 0-12 hour (AUC 0-12h) was calculated by respecifying predose concentrations as 12 hour concentrations. AUC 0-24h was calculated as AUC 0-12h multiplied by 2. Dose adjusted AUC (AUC 0-24h_Adj) was calculated by multiplying AUC 0-24h by the dose adjustment factor to obtain projected exposures in participants who were misdosed. Data were presented for AUC 0-t last, AUC 0-12h, AUC 0-24h, AUC 0-24h_Adj.|Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7|PK population. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.|||hours*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
2646785|NCT01701063|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Telaprevir|Tmax was measured for telaprevir only.|Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7|PK population. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.|||hours (h)||Full Range|Median
2646786|NCT01701063|Secondary|Maximum Plasma Concentration (Cmax) of Telaprevir|Cmax was measured for telaprevir only.|Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7|Pharmacokinetic (PK) population included all participants who received at least a single dose of telaprevir, whether the participant completed all treatments or not. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2646787|NCT01701063|Secondary|Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region|Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by age.|Baseline, On treatment (up to Week 48)|FAS. Here ‘Number of Participants Analyzed’ signifies those participants who were evaluable for this outcome and ‘n’ signifies those who were evaluable at the specified time point.|||participants|||Number
2646788|NCT01701063|Secondary|Percentage of Participants With Virologic Relapse|The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay Version 2.0. The lower limit of quantification was 25 IU/mL. Viral relapse was defined as having detectable HCV at follow-up in participants who had HCV RNA less than (<) lower limit of quantification (LLOQ) at planned EOT.|12 weeks after planned EOT (up to Week 60)|FAS included all enrolled participants who received at least 1 dose of study drug. Here 'Number of Participants Analyzed' signifies those participants who completed the assigned treatment period and had undetectable HCV RNA at EOT.|||percentage of participants|||Number
2646789|NCT01701063|Secondary|Percentage of Participants With On-treatment Virologic Failure|On treatment virologic failure was defined as meeting any futility rule or completing assigned treatment duration and having detectable HCV RNA at EOT. The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay Version 2.0. The lower limit of quantification was 25 IU/mL. Futility rules: 1) HCV RNA >1000 IU/mL at Week 4; 2) HCV RNA >1000 IU/mL at Week 12; 3) Detectable HCV RNA after Week 12 to end of treatment.|Baseline up to Week 48|FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2646790|NCT01701063|Secondary|Percentage of Participants With Undetectable HCV RNA at Week 12|The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL.|Week 12|FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2646791|NCT01701063|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL. eRVR was defined as an undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.|Week 4 and Week 12|FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2646792|NCT01701063|Secondary|Percentage of Participants With Rapid Virologic Response (RVR)|The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL. RVR was defined as an undetectable HCV RNA (<lower limit of quantification) 4 weeks after the start of study treatment.|Week 4|FAS included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2646793|NCT01701063|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)|SVR24 was defined as an undetectable HCV RNA Levels (< lower limit of quantification) at 24 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL.|24 weeks after last planned dose of study drug (up to Week 72)|SVR24 was not analyzed because study was terminated early and follow-up was conducted only up to 12 weeks after planned end of treatment (EOT).||||||
2646942|NCT01699789|Secondary|Park or Community Center Visits With Depression Service if Went to Park or Community Center||6 months follow-up||||percentage of participants||95% Confidence Interval|Mean
2647020|NCT01699022|Primary|MPA Pharmacokinetics Cmax|The mean serum concentration-time profile for MPA after three consecutive monthly intramuscular administration of Cyclofem|85 days||||ng/mL||Standard Error|Mean
2646794|NCT01701063|Secondary|Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)|SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (less than [<] lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/High Pure System (HPS) RNA assay version 2.0. The lower limit of quantification was 25 international units per milliliter (IU/mL).|12 weeks after last planned dose of study drug (up to Week 60)|Full analysis set (FAS) included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2646795|NCT01701063|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents administered during the course of the study."|Baseline up to Week 52|Safety set included all participants who received at least 1 dose of study drug.|||participants|||Number
2646796|NCT01701037|Secondary|Percentage of Biopsies With Adequate Tissue for Biomarker Analysis|Measured by the percent of tumor necrosis on hematoxylin and eosin stains; RNA gel electrophoresis, percent of adequate tissue for immunohistochemical stains in tissue microarray and cyTOF analysis.|Up to 3 months||||percentage of biopsies w/adequate tissue|||Number
2646797|NCT01701037|Secondary|Percent of Patients Completing Second and Third (Surgical) Biopsies|Biopsies will be assessed whether or not tissue is acquired at specified time points. Tissue is obtained through core, punch, incisional or excisional biopsy or surgical resection, based upon the clinical situation. Standard operating procedures for biopsies, sample preparation and analysis have been defined.|Up to 3 months||||percentage of participants|||Number
2646798|NCT01701037|Secondary|Investigational Agent Taken|Median number of pills taken|Up to 3 months||||Number of pills taken||Standard Deviation|Median
2646799|NCT01701037|Secondary|Number of Patients With Worst Grade Toxicities by Grade According to National Cancer Institute (NCI) CTCAE Version 4.0|"The intensity of the adverse event will be graded according to Version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events (June 14, 2010):~Grade 1 - Mild Grade 2 - Moderate Grade 3 - Severe or medically significant Grade 4 - Life-threatening Grade 5 - Death related to adverse event"|Up to 3 months||||participants|||Number
2646800|NCT01701037|Secondary|Change in Tumor Volume Reduction in Participants With Intrinsic Resistance to B-RAF Targeted Therapy From Day 14 to Day 28.|Tumor volume reduction is calculated as the tumor volume change relative to the baseline measurement (percent). Change in tumor volume reduction from day 14 to day 28 is calculated as the difference of tumor volume reduction at day 28 and day 14. The median and Inter-Quartile Range are reported.|Day 14 and day 28||||percentage of reduction||Inter-Quartile Range|Median
2646801|NCT01701037|Primary|Clinical Tumor Response Rate (Response is Based on Greater Than 30% Reduction From Baseline in Tumor Volume by RECIST Criteria) at Day 14.|Tumor response is defined as greater than 30% reduction from baseline in tumor volume by RECIST criteria. To determine whether a patient is responded at day 14, the patient must have the tumor volume evaluated at both baseline and day 14. The tumor response rate is calculated as the proportion of patients responded among all evaluated patients.|day 14||||proportion of responders||95% Confidence Interval|Number
2646802|NCT01701024|Primary|Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear||Baseline and 12 Weeks||||percentage of clear or almost clear|||Number
2646803|NCT01701024|Primary|Percent of Subjects Who Have a Least a 2 Grade Reduction||Baseline and 12 Weeks||||Percent with >2% reduction|||Number
2646804|NCT01701024|Primary|Absolute Change in Non-inflammatory Lesion Count||Baseline and 12 Weeks||||lesion count||Standard Deviation|Mean
2646805|NCT01701024|Primary|Absolute Change in Inflammatory Lesion Count||Baseline and 12 Weeks||||Lesion count||Standard Deviation|Mean
2646806|NCT01701011|Secondary|Depression|The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.|T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer|Only in women with embryo transfer|||units on a scale||Standard Error|Mean
2646807|NCT01701011|Primary|Anxiety|The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.|T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer|Only in women with embryo transfer|||units on a scale||Standard Error|Mean
2646808|NCT01700985|Secondary|Change in % Body Surface Area (BSA) With Psoriasis|Changes in % BSA with active psoriasis in the Treatment Area at Days 8 and 15.|baseline, Day 8 and Day 15|Analysis shown is the Intent-to-treat (ITT) population. The mean percent BSA at baseline was 4.8 for the active group (122-0551) and 4.6 for the vehicle group.|||Change in percent BSA||Standard Deviation|Mean
2646809|NCT01700985|Secondary|"Improved for Clinical Signs and Symptoms of Psoriasis"|"The percentage of subjects rated improved for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation, pruritus) at Days 8 and 15. Improved is defined as at least a 2 grade decrease in score based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe."|baseline, Day 8 and Day 15|Analysis shown is the Intent-to-treat (ITT) population.|||percentage of participants|||Number
2646810|NCT01700985|Secondary|"Treatment Success for Clinical Signs and Symptoms of Psoriasis"|"The percentage of subjects rated treatment success for each of the clinical signs and symptoms of psoriasis (scaling, erythema, plaque elevation) at Days 8 and 15. Treatment success is defined as a score of 0 or 1 based on a 5-point ordinal scale where 0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe."|baseline, Day 8 and Day 15|Analysis shown is the Intent-to-treat (ITT) population.|||percentage of participants|||Number
2646811|NCT01700985|Secondary|"ODS Improved at Day 8 and Day 15"|"The percentage of subjects rated improved with respect to ODS at Days 8 and 15. Improved is defined as at least a 2 grade decrease in ODS score relative to baseline. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe."|baseline, Day 8, and Day 15|Analysis shown is the Intent-to-treat (ITT) population.|||percentage of participants|||Number
2646812|NCT01700985|Secondary|"ODS Treatment Success at Day 8 and Day 15"|"The percentage of subjects with ODS treatment success at Day 8 and Day 15. Treatment success is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe."|baseline, Day 8, and Day 15|Analysis shown is the Intent-to-treat (ITT) population.|||percentage of participants|||Number
2646813|NCT01700985|Primary|Change in Overall Disease Severity (ODS) Score|"The percentage of subjects with ODS treatment success at EOS where EOS is the subject's last completed visit. Treatment success is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe."|baseline and Day 15 (End of Study - EOS)|Analysis shown is the Intent-to-treat (ITT) population, defined as all participants who were randomized, applied at least one dose, and had at least one follow-up visit after the Baseline visit. One study participant (VEH group) did not return to the clinic (incarcerated) following Visit 1 (baseline visit) and was excluded from the ITT population.|||percentage of participants|||Number
2646814|NCT01700959|Secondary|Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report.|Investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors (Cohort 2). The change in neurocognitive performance from baseline to 6 months will be examined in relation to change in sleep onset latency. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. The unit of measurement is a correlation coefficient (Pearson's R2). The range is from -1.0 to 1.0. A zero indicates no correlation while values closer to -1.0 or 1.0 reflect a stronger association. A negative correlation suggests that as sleep latency decreased, neurocognitive functioning improved.|Baseline and six months after start of therapy|Analysis based on intent to treat includes Cohort 2 participants randomized to melatonin who completed the 6-month assessment. Cohorts 1 and 3 were not assessed. 2 assessments of the primary outcome collected in Cohort 2 included self-report and actigraphy. 50 is the total number with actigraphy data. Data were missing for 12 participants.|||Z-score|||Number
2646815|NCT01700959|Secondary|Sleep Onset Latency as Measured by Actigraphy and Self-report.|Efficacy of melatonin on delayed sleep onset latency in long-term childhood cancer survivors (Cohorts 2 and 3 only). The measures were analyzed to compare change in sleep onset latency from baseline to 6 months between active treatment and placebo groups.|Baseline and six months after start of therapy|Analysis based on intent to treat. Includes participants who were randomized and completed the 6-month assessment.|||minutes||Standard Deviation|Mean
2646816|NCT01700959|Primary|Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.|Efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer (Cohorts 1 and 2 only). The measures were analyzed to compare change in neurocognitive performance from baseline to 6 months between active treatment and placebo groups. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. A higher z-score represents a better outcome.|Baseline and 6 months after start of therapy|Analysis based on intent to treat. Include participants who were randomized and completed the 6-month assessment.|||Z-score||Standard Deviation|Mean
2646817|NCT01700907|Secondary|The Incidence of Postoperative Delirium|The incidence of post operative delirium will be measured by Confusion Assessment Method (CAM) at baseline, 15mins, 3hrs, 6hrs, 12hrs, 24hrs, 48hrs postoperatively.|from 15 minutes to 48 hrs postoperatively|This is a pilot study.|||participants|||Number
2646818|NCT01700907|Secondary|Cognitive Function|Cognitive function will be measured by MMSE (Mini-Mental State Examination) at 24hrs pre and postoperatively. Total MMSE score is recorded by interview ranging from 0 (minimum) to 30 (maximum). MMSE score is consisted on 11 subscales, and total MMSE score is simply summation of all the subscale scores. Maximum MMSE score indicates that the patient is excellent for cognitive function. MMSE score under 26 indicated the cognitive dysfunction.|24 hrs pre and postoperatively|This is a pilot study|||Scores on a scale||Inter-Quartile Range|Median
2646819|NCT01700907|Secondary|The Time From the End of Anesthesia to Following Commands|When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.|Within 60 minutes after the end of anesthesia|This is a pilot study.|||second||Inter-Quartile Range|Median
2646820|NCT01700907|Secondary|The Time From the End of Anesthesia to Eye Opening|When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.|Within 60 minutes after the end of anesthesia|This is a pilot study.|||second||Inter-Quartile Range|Median
2646821|NCT01700907|Primary|The Time From the End of Anesthesia to Extubation|When surgery ends, the fresh gas flow rate will be increased to 6L/min (100% oxygen). Patients will be asked to open eyes by touching the shoulder, calling the name every 15 seconds. Patients will be applied stimulus every 15 seconds until following commands. Extubation will be performed when the patient is judged to be awake and spontaneous breathing recovery substantially.|Within 60 minutes after the end of anesthesia|This is a pilot study.|||second||Inter-Quartile Range|Median
2648982|NCT01681121|Primary|Evaluate the Clinical Global Impression-Change Scores for ADX-N05 vs. Placebo at Last Assessment||12 weeks|||||||
2646822|NCT01700829|Secondary|Neuropsychological Effects|The average Z-scores reported below are the average of the Z-scores for all tests administered. The Z-scores for each test were based on published normative data and normative data available in our laboratory. The population mean for a Z-score is zero, with a SD of 1, thus scores below zero would indicate performance below the population norm; a score close to zero indicates performance close to the population norm (or a normalizing of performance).|Baseline and Day 1||||score on a scale||Standard Error|Mean
2646823|NCT01700829|Secondary|Saliva Cortisol Awakening Response (CAR).|"On the mornings of an infusion day and on post-treatment day1, participants used salivettes (Sarstedt AG & Co.) to provide saliva samples upon awakening (Cort1) and 30 minutes later (Cort2) to measure cortisol awakening response (CAR) = (Cort2 - Cort1).~Differences between the midazolam and ketamine groups were tested using an analysis of covariance (ANCOVA) model of the change in CAR from baseline to day1, with treatment group and baseline measurement of the outcome variable as predictors.~Range from 0.1 to 12.5 ng/ml and lower means less stress response, higher means greater stress response."|Cort2 - Cort1 = (Day 1 30-mins post-awakening cortisol) - (Day 1 awakening cortisol)||||log(ng/mL)||Standard Deviation|Mean
2646824|NCT01700829|Primary|Change in Scale for Suicidal Ideation|Change in suicidal ideation in depressed patients with moderate to severe suicidal thoughts from the pre-infusion baseline to 24 hours after the infusion with ketamine or midazolam, a sedative not known to reduce suicidal ideation, measured with Beck Scale for Suicidal Ideation - clinician rated version. This scale has 19 items scaled 0 (least severe) to 2 (most severe) and a potential score ranging from 0 to 38, with higher score indicating greater severity.|Day 1 (24 hours) post-treatment||||units on a scale||Standard Error|Mean
2646825|NCT01700816|Secondary|Platelet Count|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group|||thousand cells/uL||Inter-Quartile Range|Median
2646826|NCT01700816|Secondary|Hematocrit (HCT)|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group|||volume percentage (vol%) of red blood ce||Inter-Quartile Range|Median
2646827|NCT01700816|Secondary|Hemoglobin (HGB)|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group|||g/dl||Inter-Quartile Range|Median
2646828|NCT01700816|Secondary|White Blood Cells (WBC)|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group|||K/uL||Inter-Quartile Range|Median
2646829|NCT01700816|Secondary|Red Blood Cells (RBC)|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group|||M/uL||Inter-Quartile Range|Median
2646830|NCT01700816|Secondary|Serum Creatinine and Blood Urea Nitrogen (BUN)|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT.|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group|||mg/dl||Inter-Quartile Range|Median
2646831|NCT01700816|Secondary|Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)|Lab values at latest available follow-up date per participant. These tests are performed as part of routine clinical care on patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).|From admission to hospital to discharge, an expected average of 28 days post-transplant|8 participants were missing lab data in the bright light group, and 7 participants were missing lab data in the sham light group|||mmol/L||Inter-Quartile Range|Median
2646832|NCT01700816|Secondary|Hospital Length of Stay||From admission to hospital to discharge, an expected average of 28 days post-transplant|One participant in the sham light arm was missing date of discharge, so only 18 hospital lengths of stay were able to be calculated in that arm.|||days||Inter-Quartile Range|Median
2646833|NCT01700816|Secondary|Average Dose of Antipsychotic Medications Required to Manage Delirium||From admission to hospital to discharge, an expected average of 28 days post-transplant|Only one case of delirium developed, and we did not collect data on antipsychotic medication use for this one participant.||||||
2646834|NCT01700816|Secondary|Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)|"Monday, Wednesday, and Friday assessments of the Memorial Delirium Assessment Scale (MDAS); Patients will receive assessments after beginning light therapy until day 28 post-transplant or discharge, whichever comes first.~10 item scale Items are rated on a four-point scale from 0 (none) to 3 (severe) depending on the level of impairment, rendering a maximum possible score of 30.~A score of 13 has been recommended as a cut-off for establishing the diagnosis of delirium"|From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant|Only one case of delirium developed, and only an MDAS score was collected for this participant.|||units on a scale|||Number
2646845|NCT01700621|Secondary|Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin G (IgG)|Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.|8 weeks post vaccination||||Participants|||Count of Participants
2646835|NCT01700816|Primary|Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale|Monday, Wednesday, and Friday assessments will begin after beginning light therapy and include the Delirium Rating Scale-Revised-98 (DRS-98)and Memorial Delirium Assessment Scale (MDAS)|From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant|Only 20 bright light therapy and 18 sham light participants were analyzed because 2 participants (one from each arm) only had one assessment. Consequently, no change could be documented to analyze change of delirium scales. They did not drop out; they just completed their transplant before more data could be gathered.|||Participants|||Count of Participants
2646836|NCT01700725|Secondary|Change in Medical Outcomes Survey Short Form-36 (SF-36) Over Baseline|SF-36 is a validated questionnaire designed to assess health status, function and overall health related quality of life. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. Gulf War Illness and chronic rhinosinusitis both affect sleep and breathing parameters. Prior studies suggest that both may be improved with SNI in some subjects. Eighteen relevant sleep and breathing related questions to the SF-36. The total range is 0-100. The lower the score, the more disability.|Baseline and weeks 8 & 26|Data from one participant at 26 weeks in the control group was unable to be collected.|||score on a scale||Standard Deviation|Mean
2646837|NCT01700725|Secondary|Change in Multidimensional Fatigue Inventory (MFI) Over Baseline|The Multidimensional Fatigue Inventory is a validated disease specific outcome measure for fatigue. The instrument has good internal consistency (average Cronbach's alpha 0.84). Construct validity was established after comparisons between and within groups, assuming differences in fatigue based on differences in circumstances and/or activity level. Convergent validity was investigated by correlating the MFI-scales with a Visual Analogue Scale measuring fatigue. Fatigue is expected to improve in the NI-treated patients compared to controls. The total range of possible scores is 0-100. The higher the score, the more fatigue.|Baseline to weeks 8 & 26|Data from several participants was unable to be collected at various timepoints.|||score on a scale||Standard Deviation|Mean
2646838|NCT01700725|Primary|Change in Sino-Nasal Outcome Test (SNOT-20) Score From Baseline|Sino-Nasal Outcome Test (SNOT-20) is a recommended tool for clinical trial research involving CRS. Sinus disease specific quality of life will be measured using the total score of this validated 20 item questionnaire. It is a reliable and valid outcome measure for patients with CRS (Cronbach's α 0.9, test-retest r = 0.9) that describes the health burden and is sensitive to clinical change. Patients who are more affected by CRS tend to have greater SNOT-20 scores (P < 0.01). The SNOT-20 score is expected to improve in NI-treated subjects compared to controls. Findings of the PI's prior RCT of adults with CRS are consistent with the above evidence. The total range of possible scores is 0-100. The higher the score, the worse the symptoms.|Change from baseline week 8, change from baseline week 26|Data from one participant in the control group and two participants in the Saline group at 26 weeks was unable to be collected.|||score on a scale||Standard Deviation|Mean
2646839|NCT01700621|Other Pre-specified|Number of Participants With Rotavirus Vaccine Shedding|Based on 5 grams of stool sample. Vaccine shedding defined as presence of vaccine-type rotavirus in stool at 4 (+/-1) and/or 7 (+/-1) days post rotavirus vaccination detected by enzyme-linked immunosorbent assay (ELISA) and typed by reverse-transcriptase polymerase chain reaction (RT-PCR).|Day 0, Day 4 and Day 7||||Participants|||Count of Participants
2646840|NCT01700621|Other Pre-specified|Geometric Mean Concentration (GMC) for Measles Virus Serum Neutralization Antibodies|Sera were analyzed for the presence of measles virus serum neutralizing antibodies (SNAs), using a standardized plaque reduction neutralization (PRN) assay, in which PRN titers, defined as the serum dilutions that reduced the number of plaques by 50%, were calculated using the Kärber method [12]. A 1:100 dilution of World Health Organization (WHO) Second International Standard Anti-Measles Serum (IS, coded 66/202, supplied by the National Institute for Biological Standards and Control, South Mimms, United Kingdom) was tested in parallel with each serum specimen to calculate the reciprocal of the 50% end point titer determined by the PRN test.|8 weeks post vaccination||||mIU/mL||95% Confidence Interval|Geometric Mean
2646841|NCT01700621|Secondary|Number/Percentage of Subjects Experiencing Serious Adverse Events|"An adverse event (AE) or suspected AE was considered serious if it resulted in any of the following outcomes:~Death~A life-threatening AE (the term life-threatening in the definition of serious refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe)~Inpatient hospitalization or prolongation of existing hospitalization~A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions~Important medical events that may not result in death, be life threatening, or require hospitalization would have been considered severe adverse events when, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition."|2 months after vaccination||||Participants|||Count of Participants
2646842|NCT01700621|Secondary|Number/Percentage of Subjects Experiencing Unsolicited Non-serious Adverse Events|Solicited non-serious adverse events were collected based on recall at study visits 2 (Day 4) through 5 (Day 14) following administration of Rotarix® vaccine. Adverse events were graded for severity and relationship to vaccine.|14 days post-vaccination||||Participants|||Count of Participants
2646843|NCT01700621|Secondary|Number/Percentage of Subjects Experiencing Solicited Adverse Events|Solicited non-serious adverse events were collected based on recall at study visits 2 (Day 4) through 5 (Day 14) following administration of Rotarix® vaccine. They included diarrhea, fever, vomiting, loss of appetite, irritability, and intussusception. Adverse events were graded for severity and relationship to vaccine.|14 days post-vaccination||||Participants|||Count of Participants
2646844|NCT01700621|Secondary|Number/Percentage of Subjects Experiencing Immediate Post-vaccination Reactions Following Administration of Vaccine|Immediate reactogenicity was defined as local or systemic reactions occurring directly and up to 30 minutes after vaccine receipt, with an emphasis on allergic reactions.|30 minutes post-vaccination||||Participants|||Count of Participants
2646846|NCT01700621|Secondary|Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin A (IgA)|Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.|8 weeks post vaccination|All subjects that met inclusion and exclusion criteria with valid samples and were not seropositive prior to the intervention|||Participants|||Count of Participants
2646847|NCT01700621|Secondary|Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin G (IgG)|Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. Rotavirus IgA and IgG values of <20 U/mL are converted to 10 U/mL for calculation purposes.|Visit 1 (pre-vaccination) and 8 weeks post vaccination|All participants meeting inclusion/exclusion criteria and with valid samples.|||U/mL||95% Confidence Interval|Geometric Mean
2646848|NCT01700621|Secondary|Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin G (IgG)|Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.|Visit 1 (pre-vaccination) and 8 weeks post vaccination|All participants meeting inclusion/exclusion criteria and with valid samples.|||Participants|||Count of Participants
2646849|NCT01700621|Secondary|Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin A (IgA)|Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. Rotavirus IgA and IgG values of <20 U/mL are converted to 10 U/mL for calculation purposes.|Visit 1 (pre-vaccination) and 8 weeks post vaccination|All participants meeting inclusion/exclusion criteria and with valid samples.|||U/mL||95% Confidence Interval|Geometric Mean
2646850|NCT01700621|Secondary|Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin A (IgA)|Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.|Visit 1 (pre-vaccination) and 8 weeks post vaccination|All participants meeting inclusion/exclusion criteria and with valid samples.|||Participants|||Count of Participants
2646851|NCT01700621|Secondary|Geometric Mean Concentration (GMC) for Anti-rubella Virus Immunoglobulin G (IgG)|Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for rubella virus. An ISR of at least 1.10 represents 10 IU/mL of rubella virus antibody, consistent with a protective level.All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).|8 weeks post vaccination||||IU/mL||95% Confidence Interval|Geometric Mean
2646852|NCT01700621|Secondary|Percentage/Number of Subjects With Seroconversion for Anti-rubella Virus Immunoglobulin G (IgG)|Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for rubella virus. An ISR of at least 1.10 represents 10 IU/mL of rubella virus antibody, consistent with a protective level.All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).|8 weeks post vaccination|All children meeting inclusion and exclusion criteria with valid samples.|||Participants|||Count of Participants
2646853|NCT01700621|Primary|Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG)|Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for measles virus. All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).|8 weeks post vaccination|All children meeting inclusion/exclusion criteria with a valid sample.|||Participants|||Count of Participants
2646854|NCT01700621|Primary|Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies|"Detected by plaque reduction neutralization test (PRNT).~Seroprotection defined as measles serum antibody concentration >=1:120 8 weeks post vaccination. Assays were standardized using WHO Second International Standard for measles antibody containing 5000 mIU/ml, which enables the 50% neutralizing antibody end-point dose (titer, ND50) of test samples to be transformed to antibody concentrations in terms of mIU/ml. The analytical cut-off value in this assay was ND50 < 1/8; this was the lowest dilution at which sera were tested."|8 weeks post vaccination||||Participants|||Count of Participants
2646855|NCT01700530|Secondary|Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity)|% change in skeletal muscle mitochondrial content (measured by citrate synthase enzyme activity) from pre to post intervention|12 weeks||||percent change||Standard Error|Mean
2646856|NCT01700530|Primary|% Change in VO2max (Fitness)|% change in fitness between baseline and after 12 weeks of treatment will be assessed by VO2max|Change from Baseline to 12 weeks|Statins blocked exercise induced change in fitness|||percentage change of VO2max||Standard Deviation|Mean
2646873|NCT01700439|Secondary|Average Subject Time on Cardiopulmonary Cross Clamp|Surgical and hospitalization factors - Cardiopulmonary cross clamp time|Day of procedure|Data is not available for 3 subjects.|||Minutes||Standard Deviation|Mean
2646857|NCT01700517|Primary|Postoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block|"The objective of this article is to evaluate the effect of femoral and sciatic-femoral block using ultrasonography by the analog visual scale (AVS) of pain in postoperatory of patients submitted to TKA, opioid consumption and complications associated to anesthesics procedures.~To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed."|48 HOURS|This sample size was calculated for a fixed effects one-way analysis of variance design. It was assumed that the standard effect size (d) = 0.5, the level of alpha (two-tailed) = 0.05, and power = 0.8, resulting in twenty six patient. The sample was stratified, having 40 patients in each of three groups to compensate for expected dropouts|||units on a scale||95% Confidence Interval|Mean
2646858|NCT01700439|Other Pre-specified|Subject's Average Plasma Free Hemoglobin at 1 Year|Laboratory Analysis of Plasma Free Hemoglobin of blood drawn from subject.|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||mg/dL||Standard Deviation|Mean
2646859|NCT01700439|Other Pre-specified|Subject's Average Hemoglobin Percentage at 1 Year|Laboratory analysis of Hemoglobin of blood drawn from subject.|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||g/dL||Standard Deviation|Mean
2646860|NCT01700439|Other Pre-specified|Subject's Average Hematocrit Percentage at 1 Year|Laboratory analysis of Hematocrit of blood drawn from subject.|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||Percentage of RBC||Standard Deviation|Mean
2646861|NCT01700439|Other Pre-specified|Subject's Average Red Blood Cell Count at 1 Year|Laboratory analysis of Red Blood Cell Count of blood drawn from subject.|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||10^6 cells/microliters||Standard Deviation|Mean
2646862|NCT01700439|Other Pre-specified|Subject's Average White Blood Cell Count at 1 Year|Laboratory analysis of White Blood Cell Count on blood drawn from subject.|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||10^3 cells/microliters||Standard Deviation|Mean
2646863|NCT01700439|Other Pre-specified|Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey|The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worst health status.|Baseline and one year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||Units on a scale||Standard Deviation|Mean
2646864|NCT01700439|Secondary|Amount of Aortic Valvular Regurgitation in Subjects at 1 Year by Valve Size|Hemodynamic performance - Aortic valvular regurgitation evaluated by echocardiography|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available. Each subject can only receive one valve and results are presented by valve size. The number of participants in each of the valve sizes totals up to the overall number analyzed.|||Participants|||Count of Participants
2646865|NCT01700439|Secondary|Subject's Cardiac Index Measurement at 1 Year|Hemodynamic performance - Cardiac index evaluated by echocardiography|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||Liters/minutes/meters squared||Standard Deviation|Mean
2646866|NCT01700439|Secondary|Subject's Cardiac Output Measurement at 1 Year|Hemodynamic performance - Cardiac Output evaluated by echocardiography|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||Liters/minutes||Standard Deviation|Mean
2646867|NCT01700439|Secondary|Subject's Performance Index Measurement at 1 Year|Hemodynamic performance - Performance Index evaluated by echocardiography|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||Centimeters squared/meters squared||Standard Deviation|Mean
2646868|NCT01700439|Secondary|Subject's Effective Orifice Area Index (EOAI) Measurement at 1 Year|Hemodynamic performance - Effective Orifice Area Index evaluated by echocardiography|1 year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||centimeters squared/meters squared||Standard Deviation|Mean
2646869|NCT01700439|Secondary|Subject's Effective Orifice Area (EOA) Measurement at 1 Year|Hemodynamic performance - Effective Orifice Area (EOA) evaluated by echocardiography|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||Centimeters squared||Standard Deviation|Mean
2646870|NCT01700439|Secondary|Subject's Average Gradient Measurements at 1 Year|Hemodynamic performance - Mean and peak gradients evaluated by echocardiography|1 Year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||mmHg||Standard Deviation|Mean
2646871|NCT01700439|Secondary|Subject's Percentage of Change at 1 Year From Baseline in New York Heart Association (NYHA) Class|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity.~Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.~Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.~Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.~Symptoms of heart failure or the anginal syndrome may be present even at rest."|Baseline and one year follow-up|This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.|||Participants|||Count of Participants
2646872|NCT01700439|Secondary|Average Number of Days Subjects Were in the Intensive Care Unit (ICU)|Length of time surgical subjects were in the intensive care unit (ICU) after their heart valve replacement procedure.|Day of procedure through discharge from the hospital|Data is not available for 5 subjects.|||Days||Standard Deviation|Mean
2646875|NCT01700439|Secondary|Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success|Procedural success is defined as device technical success followed by the absence of adverse events resulting in device reoperation implant of permanent pacemaker (with baseline sinus rhythm and no other pre-existing conduction issues), or valve-related death within discharge or 10 days post index procedure, whichever comes first.|Day of procedure through discharge or 10 days post index procedure, whichever comes first.|This outcome is reported for enrolled subjects where data is available.|||Percentage of subjects|||Number
2646876|NCT01700439|Secondary|Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success|Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with maximum of two attempts and subject leaving the operating room (OR) with valve in place.|Day of procedure|This outcome is reported for enrolled subjects where data is available.|||Percentage of subjects|||Number
2646877|NCT01700439|Primary|Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)|Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]|Events occurring ≥ 31 days and up through 2 years post-implant||||Percentage of events/late patient years|||Number
2646878|NCT01700387|Secondary|Subject's Migraine Specific Quality of Life Questionnaire (MSQ) Scores at Baseline, 3, 6, 9 and 12 Months to Measure Subject's Quality of Life||12 Months|||||||
2646879|NCT01700387|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||13 Months|||||||
2646880|NCT01700387|Secondary|Pharmacoeconomic Estimates on Number of Patients Needed to Treat (Randomize) to Have One Successful Patient at 3, 6, 9, and 12 Months.||12 Months|||||||
2646881|NCT01700387|Secondary|Subject Estimation of Compliance With Daily Topiramate||12 Months|||||||
2646882|NCT01700387|Secondary|MEWT Scores for Mathematical Processing Sub-test at Visits 2-6 to Measure Mental Efficiency||12 Months|||||||
2646883|NCT01700387|Secondary|MEWT Scores for Matching to Sample Sub-test at Visit 2-6 to Measure Mental Efficiency||12 Months|||||||
2646884|NCT01700387|Secondary|MEWT Score for Running Memory Continuous Performance Task Sub-test at Visits 2-6 to Measure Mental Efficiency||12 Months|||||||
2646885|NCT01700387|Secondary|MEWT Score for Simple Reaction Time Sub-test at Visits 2-6 to Measure Mental Efficiency||12 Months|||||||
2646886|NCT01700387|Secondary|Subject's Headache Impact Test (HIT-6) Scores at Visits 2-6 to Measure Effect of Headache in Subject's Life||12 Months|||||||
2646887|NCT01700387|Secondary|Change in Number of Headache Days Reported in 30-day Baseline Period vs. Treatment Period Months 1-12||13 Months|||||||
2646888|NCT01700387|Primary|Subject's Controlled Oral Word Association Test (COWAT) Scores at Visits 2-6 to Measure Cognitive Efficiency||12 Months|||||||
2646889|NCT01700387|Primary|Subject's Mental Efficiency Workload Test (MEWT) Overall Performance Index (PI) Score at Visits 2-6 to Measure Cognitive Efficiency||12 Months|||||||
2646890|NCT01700387|Primary|Physician Global Impression of Change (PGIC)|Score on Physician Global Impression of Change at Visits 3-6 (Day 113 and 365). Likert scale ranging from 1-7, where 1 = extremely worse and 7 = extremely better.|Collected on Visit 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365)|Number of participants vary at each visit based on the number of those still enrolled in the study at the time of the visit.|||units on a scale||Standard Deviation|Mean
2646891|NCT01700387|Primary|Subject Global Impression of Change (SGIC)|Score on Subject Global Impression of Change at Visits 3-6 (Day 113 and 365). Likert scale ranging from 1-7, where 1 = extremely worse and 7 = extremely better.|Collected on Visit 3 (Day 113), Visit 4 (Day 197), Visit 5 (281), and Visit 6 (Day 365)|Number of participants vary at each visit based on the number of those still enrolled in the study at the time of the visit.|||units on a scale||Standard Deviation|Mean
2646892|NCT01700387|Primary|Subject Attrition Post Randomization|Count of subject attrition following randomization and reason for attrition (Consent withdrawn, Withdrawn due to adverse event, Lost to follow up)|Collected on Visit 2 (Day 29) through Visit 6 (Day 365)||||participants|||Number
2646893|NCT01700348|Secondary|Percentage of Bleeding Sites|Compare the percentage of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.|2 Weeks|The study was terminated early, data were not analyzed and the plaque samples were destroyed.||||||
2646894|NCT01700348|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Assess the safety of the Sonicare AirFloss + MTB treatment.|4 Months|The study was terminated early, data were not analyzed and the plaque samples were destroyed.||||||
2646895|NCT01700348|Secondary|Plaque|Compare plaque as measured by the reduction and percent reduction in Residual Protein Concentration (RPC) following 2 and 4 weeks of use of the Sonicare AirFloss + MTB and Control Group.|4 Weeks|The study was terminated early, data were not analyzed and the plaque samples were destroyed.||||||
2646896|NCT01700348|Secondary|Number of Bleeding Sites|Compare the number of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.|2 Weeks|The study was terminated early, data were not analyzed and the plaque samples were destroyed.||||||
2646897|NCT01700348|Secondary|Gingival Inflammation|Evaluate the effect of the Sonicare AirFloss + MTB treatment on gingival inflammation as measured after 2 and 4 weeks versus baseline.|4 weeks|The study was terminated early, data were not analyzed and the plaque samples were destroyed.||||||
2646898|NCT01700348|Primary|The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group|The primary objective of the study is to compare the effect of Sonicare AirFloss + MTB treatment versus the Control Group on gingival inflammation (as measure by number of bleeding sites, and reduction in MGI) after four weeks of use.|Four Months|Terminated by financier due to low accrual & high number of protocol deviations.||||||
2646899|NCT01700335|Other Pre-specified|Maximum Tolerated Dose (MTD)|MTD was investigated with an index of DLT|Up to 16 weeks|||||||Number
2646943|NCT01699789|Secondary|Faith-based Visits With Depression Service if Faith Participation|For this sector, depression/mental health service is defined by client report of having assessment, counseling, education, medication discussion or referral for depression or emotional or mental health problems.|6 months follow-up||||percentage of patients||95% Confidence Interval|Mean
2646900|NCT01700335|Secondary|Hematologic Improvement Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 8 Weeks)|"Definition~Hematologic Improvement Erythrocyte (HI-E):~Hgb increase by >= 1.5 g/dL Relevant reduction of units of red blood cell (RBC) transfusions by an absolute number of at least 4 RBC transfusions/8 week compared with the pretreatment transfusion number in the previous 8 week. Only RBC transfusions given for a Hgb of <= 9.0 g/dL pretreatment will count in the RBC transfusion response evaluation~Hematologic Improvement Platelet (HI-P):~Absolute increase of >= 30×10^9/L for patients starting with > 20×10^9/L platelets Increase from < 20×10^9/L to > 20×10^9/L and by at least 100%~Hematologic Improvement Neutrophil (HI-N):~At least 100% increase and an absolute increase > 0.5×10^9/L~Progressive disease / Relapse:~At least 1 of the following:~At least 50% decrement from maximum response levels in granulocytes or platelets Reduction in Hgb by >= 1.5 g/dL Transfusion dependence"|Up to 60 weeks||||participants|||Number
2646901|NCT01700335|Secondary|Hematologic Remission Effect (IWG 2006 Criteria, Responses Must be Sustained at Least 4 Weeks)|"Definition~Complete remission (CR) Bone marrow: <= 5% myeloblasts; normal maturation of all cell lines Peripheral blood: Hemoglobin (Hgb) >= 11 g/dL, Platelets >= 100×10^9/L, Neutrophils >= 1.0×10^9/L, Blasts 0%~Partial remission (PR) Same as CR criteria except bone marrow blasts decreased by >= 50% over pretreatment but still > 5%~Marrow CR Bone marrow: <= 5% myeloblasts and decrease by >= 50% over pretreatment Peripheral blood: will be noted in addition to marrow CR~Stable disease Failure to achieve at least PR, but no evidence of progression for > 8 wks~Disease progression~Patients with:~Less than 5% blasts: >= 50% increase in blasts to > 5% blasts 5%-10% blasts: >= 50% increase to > 10% blasts 10%-20% blasts: >= 50% increase to > 20% blasts 20%-30% blasts: >= 50% increase to > 30% blasts~Any of the following:~At least 50% decrement from maximum remission/response in granulocytes or platelets Reduction in Hgb by >= 2 g/dL Transfusion dependence"|Up to 60 weeks||||participants|||Number
2646902|NCT01700335|Primary|Number of Participants Who Experienced Dose-limiting Toxicities (DLTs)|"A DLT was defined as adverse events for which a causal relationship with the investigational drug could not be ruled out and which met the following criteria that occurred by the final observation in Cycle 2. DLTs were also to be assessed in the Efficacy and Safety Assessment Committee.~Criteria:~Grade 3 or higher non-hematologic toxicity. However, nausea, vomiting, diarrhea, pyrexia, stomatitis, and esophagitis/dysphagia are excluded (Grade 3 nausea, vomiting, diarrhea, and pyrexia that cannot be controlled with antiemetic, antidiarrheal, or antifebrile agents are regarded as DLTs)~Grade 3 or higher stomatitis, esophagitis, and dysphagia that persist for >= 4 days"|Up to 60 weeks||||participants|||Number
2646903|NCT01700205|Secondary|Feeding Behaviors, Maternal Perceptions|Maternal perception of infant feeding behavior, using standardized questionnaires (Infant feeding style questionnaire; IFSQ); values ranged from 1 to 5; higher scores reflect more of that feeding style. Only baseline data reported herein.|0.5 months|Some mothers responded N/A on questions related to restrictive feeding styles and thus score for this subscale could not be computed.|||Units on a scale||Standard Error|Mean
2646904|NCT01700205|Primary|Energy Balance: Energy Loss in Stools|Stool EL (kcal/day) was determined from 3-day stool collection by bomb calorimetry at each timepoint|0.75, 3.5, 12.5 mos|Intent-to-treat analysis (N=113).|||kcal per day||Standard Error|Mean
2646905|NCT01700205|Primary|Energy Balance: Total Energy Expenditure (TEE)|TEE (kcal/day) was measured over 7 days at each of the three time points (0.75, 3.5 and12.5 mos) using the doubly labeled water method|0.75, 3.5, 12.5 mos|Intent-to-treat analysis (N=113).|||kcal per day||Standard Error|Mean
2646906|NCT01700205|Primary|Energy Balance: Sleeping Energy Expenditure (SEE)|Postprandial SEE (kcal/day), a proxy for resting energy expenditure in infant, was measured for a minimum of 30 min by open-circuit, indirect calorimetry using a metabolic cart with canopy hood, in a quiet, thermal-neutral room.|0.75, 3.5, 12.5 mos|Intent-to-treat analysis (N=113).|||kcal per day||Standard Error|Mean
2646907|NCT01700205|Primary|Energy Balance: Energy Intake From Infant Formula and Other Sources|Energy intake (kcal/day) of infant formula and other sources was determined by three-day weighed bottle intake and records of the infants' intake of any liquid or food other than formula during the three days|0.75, 3.5, 12.5 mos|Intent-to-treat analysis (N=113).|||kcal per day||Standard Error|Mean
2646908|NCT01700205|Primary|Growth: Length for Age (LAZ) Z Scores|At each visit, infants were measured to monitor normal growth. These anthropometric data were converted to Length for age Z (LAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).|0.5 to 12.5 months with followup visit at 18.5 mos|We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.|||Z score||Standard Error|Mean
2646909|NCT01700205|Primary|Growth, Weight for Age (WAZ) Z Score|At each visit, infants were weighed to monitor normal growth. These anthropometric data were converted to Weight for age Z (WAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).|0.5 to 12.5 months with followup visit at 18.5 mos|We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.|||Z score||Standard Error|Mean
2646910|NCT01700205|Primary|Growth, Weight for Length (WLZ) Z Scores|At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length (WLZ) Zscores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).|0.5 to 12.5 months with followup visit at 18.5 mos|We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.|||Z score||Standard Error|Mean
2646911|NCT01700192|Secondary|Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment|"Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 (no symptoms) to 100 (severe symptoms). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores)."|Last 8 weeks of treatment (Weeks 44 to 52)|The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.|||Score on a Scale||Standard Deviation|Mean
2646944|NCT01699789|Secondary|Medication Visits Among MHS Users||6 months follow-up||||percentage of participants||95% Confidence Interval|Mean
2646912|NCT01700192|Secondary|Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment|The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.|Last 8 weeks of treatment (Weeks 44 to 52)|The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.|||Score on a Scale||Standard Deviation|Mean
2646913|NCT01700192|Secondary|Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment|The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.|Last 8 weeks of treatment (Weeks 44 to 52)|The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.|||Score on a Scale||Standard Deviation|Mean
2646914|NCT01700192|Secondary|Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment|The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.|Last 8 weeks of treatment (Weeks 44 to 52)|The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.|||Score on a Scale||Standard Deviation|Mean
2646915|NCT01700192|Primary|Number of Participants Who Discontinue Study Drug Due to an AE|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 52 weeks|The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).|||Participants|||Number
2646916|NCT01700192|Primary|Number of Participants Who Experience At Least One Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 54 weeks|The All Participants as Treated (APaT) population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).|||Participants|||Number
2646917|NCT01700192|Primary|Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment|The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.|Last 8 weeks of treatment (Weeks 44 to 52)|The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.|||Score on a Scale||Standard Deviation|Mean
2646918|NCT01700179|Primary|SVR12|To determine the incidence of a sustained virologic response at 12 weeks after the completion of dosing (SVR12) with ACH-0143102 plus ribavirin, reported as HCV RNA less than the limit of quantification (<LOQ) at that time point|12 weeks following last dose||||percentage of subjects|||Number
2646919|NCT01700140|Secondary|Skin Manifestations at Study Drug Application Site|"The investigator or sub-investigator recorded skin manifestations observed after removal of the study drug.~Skin manifestations were counted for each type of patches (placebo patch, SyB D-0701 15 cm2 patch, SyB D-0701 25 cm2 patch)."|Up to 192 hours|"Skin manifestations were counted for each type of patch applied to the subjects in the safety population.~Placebo patch : 60-1+63+60=182 (One subject in placebo group did not applied 15 cm2 patch.)~SyB D-0701 15 cm2 patch : 62~SyB D-0701 25 cm2 patch : 62+63=125"|||Number of events|||Number
2646920|NCT01700140|Secondary|Severe (Grade 3 or More) Adverse Events|"The severity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.~Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE"|Up to 192 hours|"Safety population:~The safety population consisted of all subjects enrolled, except for subjects with GCP non-compliance and those who failed to receive the study treatment."|||Number of events|||Number
2646921|NCT01700140|Secondary|Adverse Events|Adverse event is any untoward medical occurrence experienced by a subject irrespective of causal relationship with the study drug, and includes the unexpected signs, clinically significant fluctuations of laboratory data, and aggravation of disease, symptoms or complications. Adverse events are coded using the preferred terms (PT) of Medical Dictionary for Regulatory Activities (MedDRA) version 15.0.|Up to 192 hours|"Safety population:~The safety population consisted of all subjects enrolled, except for subjects with Good Clinical Practice (GCP) non-compliance and those who failed to receive the study treatment."|||Participants|||Number
2646922|NCT01700140|Secondary|Complete Response Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3|"Complete response rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.~The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs."|24-72 hours|"Per protocol set:~Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."|||Percentage of participants|||Number
2646923|NCT01700140|Secondary|Complete Control Rate Within 24 Hours After Each Irradiation From Sessions 1 to 3|"Complete control rate within 24 hours after each irradiation, from the first to the third fraction of radiotherapy.~The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs."|24-72 hours|"Per protocol set:~Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."|||Percentage of participants|||Number
2646924|NCT01700140|Secondary|Time to First Nausea|Time from the start of radiotherapy to the onset of first nausea. The median (50% point) of time to first nausea was estimated.|24-72 hours|"Per protocol set:~Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."|||Hours||95% Confidence Interval|Median
2646945|NCT01699789|Secondary|>= 2 PCP Visits With Depression Services, if Any||6 months follow-up||||percentage of participants||95% Confidence Interval|Number
2646926|NCT01700140|Secondary|Complete Response (no Signs of Emesis and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation|The complete response rate was defined as the percentage of subjects who had no emesis and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.|72 hours|"Per protocol set:~Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."|||Percentage of participants|||Number
2646927|NCT01700140|Primary|Complete Control (no Signs of Emesis or Moderate to Severe Nausea and no Use of Rescue Medication) Rate From the Start of Radiotherapy Until 24 Hours After the Third Irradiation|The complete control rate was defined as the percentage of subjects who had no emesis and no moderate or more severe nausea and who used no rescue drugs during the period from the time of the first irradiation to 24 hours after the third irradiation.|72 hours|"Per protocol set:~Of all the randomized subjects, those who were compliant with the protocol were included in the per protocol set."|||Percentage of participants|||Number
2646928|NCT01700049|Secondary|Onset of Efficacy of Vismodegib|Onset of efficacy was measured by tumor surface area reduction or increase. Subjects had one target lesion and up to 3 additional non-target lesions. Surface area of a cumulative total of 65 tumors (27 target lesions and 38 non-target lesions) was measured after 24 weeks of treatment. A complete response was defined as 100% reduction in tumor surface area. Partial response was defined as greater than 50% reduction in tumor surface area. Stable disease was defined as less than 50% reduction in tumor surface area and Progressive disease was defined as greater than 20% increase in tumor surface area.|Up to week 24||||tumors|tumors||Count of Units
2646929|NCT01700049|Secondary|Safety of Vismodegib|The safety of Vismodegib was evaluated by monitoring adverse effects. All adverse events, expected and unexpected, were recorded and categorized using the Common Terminology Criteria for Adverse Events (CTCAE) guide. This is a set of criteria from the National Cancer Institute (NCI) used to standardize classification of adverse effects of drugs. Grade 1 events are defined as mild, grade 2 as moderate, grade 3 as severe; grade 4 as life-threatening and grade 5 as death.|Up to 18 months||||adverse events|||Number
2646930|NCT01700049|Primary|Efficacy of Vismodegib|The efficacy of vismodegib was defined as the number of tumor biopsies with positive pathology after 24 weeks. Subjects had one target lesion and up to 3 additional non-target lesions. A cumulative total of 65 tumors was measured after 24 weeks of treatment. Histopathological subtypes were categorized primarily as infiltrative, nodular and superficial.|Week 24|A total of 65 tumors were categorized into histopathologic subtype where 24 of 65 were infiltrative, 29 of 65 were nodular, 10 of 65 were superficial and 2 out of 65 were keratotic.|||tumors|tumors||Count of Units
2646931|NCT01700036|Secondary|Mean Plasma Levels for Alpha-1-Antitrypsin (AAT)|Plasma levels of Alpha-1-Antitrypsin(AAT)will be measured.|4 weeks||||mg/dl||Standard Error|Mean
2646932|NCT01700036|Secondary|Mean Fold Change in Plasma Biomarkers|The fold change in levels of plasma biomarkers IL-6, TNF-alpha and ST2 will be measured pre-treatment and after the administration of AAT treatment for steroid refractory GvHD.|Baseline, 2 weeks, and 4 weeks||||fold change from baseline||Standard Error|Mean
2646933|NCT01700036|Secondary|The Percentage of Patients Alive at 6 Months for Patients in CR or PR|"Survival at 6 months in patients receiving AAT treatment for steroid refractory acute GVHD for patients that achieved a CR or PR.~Partial Response (PR) is defined as a decrease of at least one grade in the severity of GVHD without deterioration of any organ systems by d28 of therapy.~Complete Response (CR) is defined as the resolution of all manifestations of GVHD by d28 of treatment. All organs must have a Stage 0."|6 months|40 patients were enrolled and 26 patients achieved a CR or PR.|||percentage of patients||95% Confidence Interval|Number
2646934|NCT01700036|Secondary|Percentage of Patients With Documented Infection|To estimate the incidence of infection during and following treatment of steroid refractory acute GVHD with AAT|30 days||||percentage of patients|||Number
2646935|NCT01700036|Secondary|Percentage of Patients Who Achieve a Complete Response to Treatment|"To estimate the proportion of patients in complete remission without additional therapy at four weeks after the last dose of AAT~Complete remission is defined as the resolution of all manifestations of GVHD by d28 of treatment. All organs must have a Stage 0."|4 weeks||||percentage of patients||95% Confidence Interval|Number
2646936|NCT01700036|Primary|Percentage of Patients That Respond to Treatment|"To estimate the proportion of patients with steroid refractory acute Graft vs Host Disease) GvHD who respond (achieve either PR or CR) to Alpha-1 Antitrypsin (AAT) at a dose of 60mg/kg twice weekly for 8 doses~Partial Response (PR) is defined as a decrease of at least one grade in the severity of GVHD without deterioration of any organ systems by d28 of therapy.~Complete Response (CR) is defined as the resolution of all manifestations of GVHD by d28 of treatment. All organs must have a Stage 0."|4 weeks||||percentage of patients||95% Confidence Interval|Number
2646937|NCT01699867|Primary|Number of Margins With False Positive Device Readings||one week after surgery|Patients with all negative margins (≥ 2 mm). On average, 5 out of 6 possible margins were analyzed per patient.|||False positive margins per patient||Standard Deviation|Mean
2646938|NCT01699867|Primary|Patients With All Positive Margins Correctly Identified With the Device|"In this study, a patient had positive margins if tumor was identified at the true margin (i.e., the final margin or new margin) surface of at least one specimen by histology (0 mm, tumor on ink)."|one week after surgery|"Patients with positive margins (0 mm, tumor on ink)."|||Patients w/ all positives identified|||Number
2646939|NCT01699815|Other Pre-specified|Average Length of Stay (LOS)|To compare patient length of stay (LOS) between groups as measured by day of discharge minus day of admission.|Baseline to discharge (1-4 days)||||days||Standard Deviation|Mean
2646940|NCT01699815|Secondary|Pain Medication Consumption Rates|Number of participants who required rescue pain medication. Rescue pain medications is defined as administration of pain medication in excess of standard postoperative pain medication orders.|Arrival to post-anesthesia care unit (PACU or recovery room) (2-3 hours post baseline) to 24 hours post administration of study drug||||participants|||Number
2646941|NCT01699815|Primary|Changes in Postoperative Pain Scores|To compare analgesic efficacy as measured by changes in postoperative pain scores assessed preoperatively, at 6, 12, 18, and 24 hours following the initial administration of the study drug. Pain scores are assessed on a scale of 0 - 10. 0 = No Pain; 10 = Worst Possible Pain|preoperatively (baseline), post-anesthesia care unit (PACU or recovery room) arrival (2-3 hour), and 6,12, 18, and 24 hours following the initial administration of the study drug||||units on a scale||Standard Deviation|Mean
2646951|NCT01699789|Secondary|Total Outpatient Contacts for Depression|Total outpatient contacts for depression, mental health or substance abuse from emergency rooms, primary care or public health, mental health, substance abuse, or social-community services sectors|12 months follow-up||||mean number of visits||95% Confidence Interval|Number
2646952|NCT01699789|Secondary|Total Outpatient Contacts for Depression|Total outpatient contacts for depression, mental health or substance abuse from emergency rooms, primary care or public health, mental health, substance abuse, or social-community services sectors|6 months follow-up||||mean number of visits||95% Confidence Interval|Mean
2646953|NCT01699789|Secondary|Took Antidepressant 2 Months or More in Past 6 Months|Took antidepressant two months or more past 6 months, %|12 months follow-up||||percentage of participants||95% Confidence Interval|Number
2646954|NCT01699789|Secondary|Took Antidepressant 2 Months or More in Past 6 Months|Took antidepressant two months or more past 6 months, %|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
2646955|NCT01699789|Secondary|Use of Park or Community Centers|Any use of parks or community centers, %|12 months follow-up||||percentage of participants||95% Confidence Interval|Number
2646956|NCT01699789|Primary|PHQ-9 Score ≥ 10|Mild/moderate depression defined as PHQ-9 score ≥ 10.|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
2646957|NCT01699789|Secondary|Use of Park or Community Centers|Any use of parks or community centers, %|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
2646958|NCT01699789|Secondary|Faith-based Program Participation|Any faith-based program participation, %|12 months follow-up||||percentage of participants||95% Confidence Interval|Number
2646959|NCT01699789|Secondary|Faith-based Program Participation|Any faith-based program participation, %|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
2646960|NCT01699789|Secondary|PCP Visit With Depression Service|Any primary care visit with depression service, %|12 months follow-up||||percentage of participants||95% Confidence Interval|Number
2646961|NCT01699789|Secondary|PCP Visit With Depression Service|Any primary care visit with depression service, %|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
2646962|NCT01699789|Secondary|MHS Outpatient Visit|Any mental health outpatient visit, %|12 months follow-up||||percentage of participants||95% Confidence Interval|Number
2646963|NCT01699789|Secondary|MHS Outpatient Visit|Any mental health outpatient visit, %|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
2646964|NCT01699789|Secondary|Hospitalization for Behavioral Health|Any hospitalization for alcohol, drug, mental health, %|12 months follow-up||||percentage of participants||95% Confidence Interval|Number
2646965|NCT01699789|Secondary|Hospitalization for Behavioral Health|Any hospitalization for alcohol, drug, mental health, %|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
2646966|NCT01699789|Primary|Poor Mental Health Quality of Life, MCS12≤ 40|From the Short Form, 12-item quality of life measure, mental health-related quality of life is the primary client outcome. Poor mental health related quality of life is defined as MCS12≤ 40 (one standard deviation below population mean).|12 months follow-up||||percentage of participants||95% Confidence Interval|Number
2646967|NCT01699789|Secondary|Homeless or ≥ 2 Risk Factors for Homelessness|Being homeless or having no place to stay for 2 nights or more; food insecurity; eviction from primary place of residence; or major financial crisis from items in client surveys. Homeless/shelter (pure, demo306=7) or >=2 risk factor for homelessness out of 4 items diff1 diff2 diff11 diff6)|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
2646968|NCT01699789|Secondary|Physically Active|Items on physical activity that are self-reported in the client survey, drawn from the SF-12 and measures of exercise and physical activity. how physically active you are (cond606>=3), 1=Quite/very/extreme active, %|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
2646969|NCT01699789|Secondary|Mental Wellness|Mental Wellness, % (at least good bit of time on 3 items on feeling peaceful or, calm, been a happy person, having energy), at least 1 item out of 3.|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
2646970|NCT01699789|Primary|Poor Mental Health Quality of Life, MCS12≤ 40|From the Short Form, 12-item quality of life measure, mental health-related quality of life is the primary client outcome. Poor mental health related quality of life is defined as MCS12≤ 40 (one standard deviation below population mean).|6 months follow-up||||percentage of participants||95% Confidence Interval|Number
2646971|NCT01699763|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)|"Using samples with YSI plasma Blood Glucose (BG) >180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value."|8 hours|Same number (106) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 333), of which 106 samples were greater than 180 mg/dL.|||Percent Difference|Participants|Standard Error|Mean
2646972|NCT01699763|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range (<=80 mg/dL)|"Using fresh and glycolyzed samples with YSI plasma Blood Glucose (BG) ≤80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value."|8 hours|Same number (107) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 333), of which 107 samples were less than or equal to 80 mg/dL.|||Percent Difference|Participants|Standard Error|Mean
2646973|NCT01699763|Primary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range|"Using the overall Blood Glucose (BG) range (34 to 561 mg/dL according to YSI subject plasma results), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI plasma results (BG reference) were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 3 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value. Higher MARD value indicates larger difference between meter value and the reference value."|8 hours|Same number 333 (336-3) BG results possible for each BGMS. Staff collected 3 capillary samples from each subject - total 336 samples. Three samples from one subject were not analyzed. Subject hematocrit (58.5) was above the study evaluable limit of 55.|||Percent Difference|Participants|Standard Error|Mean
2646974|NCT01699750|Secondary|Minimum Protected Area|Minimum protected area (i.e., minimum area of the lens (%) covered by the tear film during the interblink period) was measured using a diffuse illumination source (Tearscope) and videotography. A higher value indicates a larger area of the tearfilm spread evenly over the lens (i.e., less area of tear film breakage). One eye (study eye) contributed to the mean.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.|||percentage of lens surface covered||Standard Deviation|Mean
2646975|NCT01699750|Secondary|Average Exposure Speed|Exposure speed (rate of increase in exposed lens surface % (areas not protected by tear film) after the first tear film break and before the second blink) was measured with a diffuse illumination source (Tearscope) and videotography. Higher speeds indicate worse tear film dynamics. One eye (study eye) contributed to the mean.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.|||percent of area exposed/second||Standard Deviation|Geometric Mean
2646976|NCT01699750|Secondary|Overall Dryness Measured With Visual Analog Scale (VAS)|The participant rated overall dryness on a 100-millimeter analog scale by marking a line that best describes how dry their eyes feel (0=not at all dry, 100=very dry). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2646977|NCT01699750|Secondary|Overall Comfort Measured With Visual Analog Scale (VAS)|The participant rated overall comfort on a 100-millimeter analog scale by marking a line that best corresponds to their eye comfort (0=very poor, 100=excellent). Both eyes were rated together as a single, retrospective evaluation of the previous 3 days of wear.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint.|||units on a scale||Standard Deviation|Mean
2646978|NCT01699750|Secondary|LogMAR Time-Controlled Visual Acuity (TCVA)|Visual performance was measured binocularly (both eyes together) at two contrast levels using a validated Time Controlled Visual Acuity test (TCVA). TCVA was recorded in VA units (1 VA unit=1 VA line=0.1 logMAR), with positive (+) values corresponding with VA better than 20/20 and negative (-) values worse than 20/20.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy. Two Day 30 measurements per participant contributed to analysis.|||VA unit||Standard Deviation|Mean
2646979|NCT01699750|Secondary|Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT)|The pre-lens tear film is the layer of tears located on top of the contact lens between the eyelid and the contact lens. NIBUT (i.e., the time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film) was measured using a diffuse illumination source (Tearscope) and videotography. A longer NIBUT indicates a more stable tear film and greater on-eye lens wettability. One eye (study eye) contributed to the mean.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.|||seconds||Standard Deviation|Geometric Mean
2646980|NCT01699750|Primary|Mean Ex-Vivo Total Lipid Uptake Per Lens|The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.|Day 30|This analysis group includes all participants who had a baseline and at least one post-baseline measurement of the primary efficacy endpoint. Two Day 30 measurements per participant (one eye per Day 30) contributed to analysis.|||micrograms||Standard Deviation|Geometric Mean
2646981|NCT01699698|Secondary|The Sensitivity and Specificity to Detect UICC Stage II Pancreatic Ductal Adenocarcinoma Among All Participants.|Based on each analyzing result of pancreatic cancer markers and corresponding final diagnosis, a receiver operating characteristic (ROC) is evaluated. A cut-off is then chosen from this ROC curve to maximize both sensitivity and specificity.<Method>1. create an ROC curve using the measured concentrations, 2. set a threshold, 3. report how many patients in each group would are exceeded the threshold. (The rate of exceeded threshold in Test subject group is sensitivity, The rate of 1-(the rate of exceeded threshold in Control group) is specificity.)|1 year||||participants|||Number
2646982|NCT01699698|Primary|The Concentration of the Pancreatic Cancer Markers of the Normal Cohort and UICC Stage II Pancreatic Ductal Adenocarcinoma Cohort|"We hypothesized that there is a statistically-significant difference between two cohorts.~The cancer marker is S100P."|1year||||pg/ml||Full Range|Median
2646983|NCT01699685|Secondary|Airway Resistance (Raw)|Raw was measured with spirometry conducted according to internationally accepted standards. Raw was the mean of the measurements which were measured each at 30, 60, 120, 180 and 240 minutes|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis|||cmH2O/l/s||Standard Deviation|Mean
2647021|NCT01699022|Primary|MPA Pharmacokinetics|The mean serum concentration-time profile for MPA after three consecutive monthly intramuscular administration of Cyclofem (AUC)|"Day 85"||||ng.day/mL||Standard Error|Mean
2646984|NCT01699685|Secondary|Total Lung Capacity (TLC)|TLC was measured with spirometry conducted according to internationally accepted standards. Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30, 60, 120, 180 and 240 minutes post dose|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis|||Liters||Standard Deviation|Mean
2646985|NCT01699685|Secondary|Forced Volume Capacity (FVC)|FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis|||Liters||Standard Deviation|Mean
2646986|NCT01699685|Secondary|Inspiratory Capacity (IC)|During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured at 30, 60, 120, 180, and 240 minutes post-dose|within 4h after dosing|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis|||Liters||Standard Deviation|Mean
2646987|NCT01699685|Secondary|Forced Expiratory Volume in One Second (FEV1)|FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was at 30, 60, 120, 180, and 240 minutes post-dose. Spirometry equipment and performance of spirometric testing had to be in accordance with standards as outlined in the American Thoracic Society for the Standardization of Spirometry recommendations. The spirometry equipment used during the study had to meet or exceed these minimal ATS recommendations|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis|||Liters||Standard Deviation|Mean
2646988|NCT01699685|Primary|Inspiratory Capacity (IC) Peak Value|IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean at one of the post-dose measurements (30min, 60min, 120min, 180min and 240min).|Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours|Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 4 hours were included in the analysis.|||Liters||Standard Deviation|Mean
2646989|NCT01699607|Primary|Change in Dopamine Levels at Baseline and After Amphetamine Administration as Measured by Percent Change in PET Tracer Binding Potential.|PET images will be obtained in subjects at baseline and after amphetamine administration. Dopamine release will be measured as a percent change in binding potential. Increased dopamine release will result in decreased radiotracer binding because dopamine will displace the radiotracer.|first 90 minute scan at baseline, second 90 minute scan start 150 minutes post amphetamine administration||||percent change in binding potential||Standard Deviation|Mean
2646990|NCT01699503|Secondary|Number of Participants With an Advance Directive at 12 Months|The study team will measure the subjects' advanced care planning including having power attorney for health care and/or financial affairs, having a living will, and having life and additional insurance policies at 12 months.|12 months|The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.|||Participants|||Count of Participants
2646991|NCT01699503|Secondary|Number of Participants With Health Care Utilization|The study team will obtain consent at enrollment from all subjects for permission to review their medical records. The Indiana Network for Patient Care (a fully operational Health Information Exchange) will also be used to identify any episode of ambulatory or acute care that occurred within the following 12 months of enrollment date.|12 months||||Participants|||Count of Participants
2646992|NCT01699503|Primary|Generalized Anxiety Disorder Scale (GAD-7)|The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of general anxiety disorder. A higher score is associated with more severe anxiety.|1 month, 6 months, 12 months|The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.|||units on a scale||Standard Deviation|Mean
2646993|NCT01699503|Primary|Patient Health Questionnaire (PHQ-9)|The PHQ-9 is a nine-item depression scale with a total score from 0 to 27. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of major depression. A higher score is associated with more severe depression.|1 month, 6 months, 12 months|The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.|||units on a scale||Standard Deviation|Mean
2646994|NCT01699503|Primary|Health Related Quality of Life (HRQOL)|The primary outcome measure will be the HRQOL measured at baseline, 1, 6 and 12 months among the entire 4,000 enrollees. The study will use the 15-item Health Utility Index (HUI) to determine the subject's HRQOL. The HUI is a generic, utility-based HRQOL instrument applied in patients with a wide range of medical conditions. It has eight attributes: Vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. The individual health domain scores range from 0.00 (maximum impairment) to 1.00 (no impairment) and the multi-attribute (HUI index) scores, a multiplicative function of individual attribute levels, range from 0.36 to 1.00 with anchors 0.00 = dead and 1.00 = perfect health.|1 month, 6 months, 12 months|The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.|||units on a scale||Standard Deviation|Mean
2646995|NCT01699373|Secondary|Time Taken to Perform Spinal Anaesthesia||During procedure|||||||
2646996|NCT01699373|Primary|Success Rate of First-attempt of Spinal Anaesthesia||During procedure||||participants|||Number
2646997|NCT01699178|Primary|Absolute Change From Baseline in Prostate Volume|Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.|Approximately 365 days|The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.|||cc||95% Confidence Interval|Mean
2646998|NCT01699178|Primary|Absolute Change From Baseline in Hct|Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.|Approximately 365 days|The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.|||percent||95% Confidence Interval|Mean
2646999|NCT01699178|Primary|Absolute Change From Baseline in Hgb|Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.|Approximately 365 days|The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.|||g/dL||95% Confidence Interval|Mean
2647000|NCT01699178|Primary|Absolute Change From Baseline in LDL|Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.|Approximately 365 days|The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.|||mg/dL||95% Confidence Interval|Mean
2647001|NCT01699178|Primary|Absolute Change From Baseline in HDL|Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.|Approximately 365 days|The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.|||mg/dL||95% Confidence Interval|Mean
2647002|NCT01699178|Primary|Absolute Change From Baseline in T Cholesterol|Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.|Approximately 365 days|The number analyzed is less than the number of participants who began the study due to early withdrawals from study, and no available data for comparison to baseline values.|||mg/dL||95% Confidence Interval|Mean
2647003|NCT01699087|Primary|Percentage of Eyes With > 2.0 D of Induced Manifest Refractive Cylinder Magnitude, as Compared to Baseline, at Refractive Stability|Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter. The cylinder value is from the manifest refraction assessment. The induced manifest refractive cylinder is the change in magnitude of cylinder compared to baseline.|Month 6 (post second eye surgery)|ITT|||percentage of eyes|eyes||Number
2647004|NCT01699087|Primary|Percentage of Eyes With a BSCVA Worse Than 20/40 (for Eyes With BSCVA of 20/20 or Better Preoperatively) at Refractive Stability|Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions .|Month 6 (post second eye surgery)|ITT|||percentage of eyes|eyes||Number
2647005|NCT01699087|Primary|Percentage of Eyes With BSCVA Decrease of ≥ 2 Lines From Baseline at Refractive Stability|Visual acuity with correction was assessed monocularly using the ETDRS chart at 4 meters under photopic conditions . A decrease in 2 lines or more is considered clinically relevant (i.e. worse).|Month 6 (post second eye surgery)|ITT|||percentage of eyes|eyes||Number
2647006|NCT01699087|Primary|Cumulative Incidence of Ocular Serious Adverse Events by Eye|Participants were followed for the duration of the study, an expected average of 24 months.|Up to Month 24 (post second eye surgery)|ITT|||eyes|eyes||Number
2647007|NCT01699087|Primary|Percentage of Eyes That Have a Change of ≤ 1.0 D in MRSE and Manifest Refractive Cylinder Between Consecutive Scheduled Visits|MRSE is calculated as sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.|Up to Month 24 (post second eye surgery)|ITT|||percentage of eyes|eyes||Number
2647008|NCT01699087|Primary|Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 0.5 D of Zero at Refractive Stability|Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.|Month 6 (post second eye surgery)|ITT|||percentage of eyes|eyes||Number
2647009|NCT01699087|Primary|Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 1.0 D of Zero at Refractive Stability|Manifest refraction was performed monocularly under photopic lighting conditions using an ETDRS chart at 4 meters. The subject was manually refracted to his/her best correction using a phoropter.|Month 6 (post second eye surgery)|ITT|||percentage of eyes|eyes||Number
2647010|NCT01699087|Primary|Percentage of Eyes Achieving MRSE Within ± 0.5 D of Zero at Refractive Stability|Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.|Month 6 (post second eye surgery)|ITT|||percentage of eyes|eyes||Number
2647011|NCT01699087|Primary|Percentage of Eyes Achieving Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.0 D of Zero at Refractive Stability|Manifest refraction spherical equivalent (MRSE) is calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values are from the manifest refraction assessment. The manifest refraction assessment was conducted monocularly with the ETDRS chart at 4 meters under photopic conditions using a phoropter.|Month 6 (post second eye surgery)|ITT|||percentage of eyes|eyes||Number
2647012|NCT01699087|Primary|Percentage of Eyes Achieving Uncorrected Visual Acuity (UCVA) of 20/40 or Better at Refractive Stability in Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) of 20/20 or Better Preoperatively|Visual acuity, with and without correction, was assessed monocularly using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 4 meters under photopic conditions . The with-correction assessment was made with the manifest refraction at 4 meters.|Month 6 (post second eye surgery)|Intent to treat (ITT)|||percentage of eyes|eyes||Number
2647023|NCT01698814|Primary|Adverse Events|An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.|An average of 6 weeks|This reporting group includes all randomized subjects who received study medication.|||participants|||Number
2647024|NCT01698801|Secondary|Number of Participants With Adverse Events|An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.|From first dose of study drug treatment through to 28 days after the last dose, until the data cut-off date of 15 July 2014; median treatment duration was 60 weeks|Safety population includes all participants who received at least one dose of study drug.|||participants|||Number
2647025|NCT01698801|Secondary|Overall Survival (OS)|The time from the start of study treatment to death due to any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.|From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow up is 14.2 months|Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.|||months||95% Confidence Interval|Median
2647026|NCT01698801|Secondary|Progression Free Survival (PFS)|PFS was calculated as the time from the first dose date to the first documented progression based on IWG criteria or death due to any cause, whichever occurred first. If progression or death was not documented at the time of data cutoff date, these observations were censored at the last adequate assessment date showing evidence of no progression or death.|From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up for PFS assessments was 61.6 weeks.|Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.|||months||95% Confidence Interval|Median
2647027|NCT01698801|Secondary|Duration of Response|Duration of response was calculated for the responders as the time from the initial documented response (CR or VGPR or PR) to the first documented progression or death due to any cause, whichever occurred first. Duration of response for participants last known to be alive with no progression after a CR, VGPR, or PR were censored at the date of last adequate response assessment.|From the first dose of study drug treatment until the data cut-off date of 15 July2014. Median follow up time was 61.6 weeks.|Efficacy Evaluable (EE) Population consists of all participants who meet protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug|||months||95% Confidence Interval|Median
2647028|NCT01698801|Secondary|Time to Response|"Time to response was calculated for the responders as the time from the first dose date to the initial documented response (CR, VGPR or PR).~CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required."|From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up time was 61.6 weeks.|Efficacy Evaluable (EE) Population consists of all participants who meet protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug|||months||Full Range|Median
2647029|NCT01698801|Primary|Overall Response Rate|"Number of Complete Responses (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria (IMWG). Any participant who achieved a CR, VGPR, or PR while on study treatment was defined as a responder.~CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required."|From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks.|Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.|||percentage of participants|||Number
2647030|NCT01698775|Secondary|Change From Baseline in eGFR at Week 54|Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with ESRD on dialysis.|Baseline and Week 54|APaT population consists of all randomized participants who took at least 1 dose of trial treatment. Excludes all participants on dialysis and data after initiation of dialysis. Phase B includes 1 omarigliptin participant in the severe renal impairment stratum (not on dialysis) who was misclassified in the ESRD stratum on dialysis during Phase A.|||mL/min/1.73 m^2||95% Confidence Interval|Least Squares Mean
2647069|NCT01698320|Other Pre-specified|Daily AM Peak Expiratory Flow (PEF) to Week 52|Daily AM PEF will be recorded throughout the duration of the study to provide information on the subject's asthma status in order to assist in distinguishing between the use of back-up rescue medication related to an increased need for asthma symptom relief from that related to an issue with the Albuterol Spiromax® rescue inhaler.|Baseline to Week 52|||||||
2647031|NCT01698775|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24|Based on an cLDA model including terms for treatment, renal status stratum, treatment on insulin at screening stratum, time, the interaction of time by treatment, the interaction of time by renal status stratum, and the interaction of time by treatment on insulin at screening stratum, with the constraint that the mean baseline is the same for all treatment groups. Excluding data after glycemic rescue or initiation of dialysis as well as participants classified with end stage renal disease (ESRD) on dialysis.|Baseline and Week 24|APaT population consists of all randomized participants who took at least 1 dose of trial treatment. Excludes participants on dialysis and data after initiation of dialysis. One omarigliptin participant with severe renal impairment was misclassified as ESRD on dialysis in Phase A and was excluded from the Phase A analysis (corrected in Phase B).|||mL/min/1.73 m^2||95% Confidence Interval|Least Squares Mean
2647032|NCT01698775|Secondary|Change From Baseline in FPG at Week 54|Change from baseline in FPG at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.|Baseline and Week 54|FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least 1 dose of study medication.|||mg/dL||95% Confidence Interval|Least Squares Mean
2647033|NCT01698775|Secondary|Change From Baseline in A1C at Week 54|A1C is measured as a percent. Change from baseline in A1C at Week 54 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.|Baseline and Week 54|FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least 1 dose of study medication.|||Percent||95% Confidence Interval|Least Squares Mean
2647034|NCT01698775|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change from baseline in FPG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.|Baseline and Week 24|FAS population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement in Phase A for the analysis endpoint subsequent to at least 1 dose of study medication.|||mg/dL||95% Confidence Interval|Least Squares Mean
2647035|NCT01698775|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.|Up to 54 weeks|APaT population consists of all randomized participants who took at least 1 dose of trial treatment.|||Percentage of participants|||Number
2647036|NCT01698775|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period + Phase B: 30-week Active Controlled Period)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.|Up to 58 weeks (including 28 days following the last dose of study therapy)|APaT population consists of all randomized participants who took at least 1 dose of trial treatment.|||Percentage of participants|||Number
2647037|NCT01698775|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A: 24-week Placebo Controlled Period)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.|Up to 24 weeks|APaT population consists of all randomized participants who took at least 1 dose of trial treatment.|||Percentage of participants|||Number
2647038|NCT01698775|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (Phase A: 24-week Placebo Controlled Period)|An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue.|Up to 28 weeks (including 28 days following the last dose of study therapy for participants who discontinued study drug)|All-Participants-as-Treated (APaT) population consists of all randomized participants who took at least 1 dose of trial treatment.|||Percentage of participants|||Number
2647039|NCT01698775|Primary|Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24|A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, renal insufficiency stratum, baseline treatment with insulin stratum, time, the interaction of time by treatment, the interaction of time by renal insufficiency stratum, and the interaction of time by baseline treatment with insulin stratum.|Baseline and Week 24|Full analysis set (FAS) population included all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a post-randomization measurement in Phase A for the analysis endpoint subsequent to at least 1 dose of study medication.|||Percent||95% Confidence Interval|Least Squares Mean
2647040|NCT01698710|Secondary|Size of Cystic Lesion|Determine the size of the cystic lesion using CT scanning. Number of participants with reduction in size, persistent size, or increase in size of cyst are reported.|3-10 months (median 6 months) after injection therapy||||Participants|||Count of Participants
2647094|NCT01697709|Primary|Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study|The median daily dollar value of marijuana used averaged over a one-week period for each of the 12 weeks as recorded by the Timeline Followback method|12 weeks or length of participants involvement||||dollars||Inter-Quartile Range|Median
2647041|NCT01698710|Secondary|Feasibility of Endoscopic Ultrasonography (EUS) Guided Injection of Albumin-bound Paclitaxel Into Pancreatic Cysts|The feasibility of the procedure will be measured by the ease of injection of albumin-bound paclitaxel into the cyst cavity across the gastro-duodenal wall. On a subjective scale, the endoscopist will note the ease of the procedure on a scale of 0-5, with 5 being very easy and 0 is not possible. Any score less than 2 will be considered unacceptable and failure of the study.|immediately after procedure||||units on a scale||Full Range|Median
2647042|NCT01698710|Primary|Frequency of Pancreatitis|Safety of injection of albumin-bound paclitaxel will be measured by the frequency of pancreatitis.|3-10 months (median 6 months) after injection therapy||||Participants|||Count of Participants
2647043|NCT01698684|Primary|Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing||Week 0 (Baseline) up to Week 8 (End of Study)|The intent-to-treat (ITT) population consists of all subjects who are randomized, take at least 1 dose of study medication, and have at least 1 post-dose efficacy assessment.|||percentage of successes||Standard Deviation|Mean
2647044|NCT01698554|Secondary|Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9)|"Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: Overall, how satisfied are you with your eyelashes? using a 5-point scale: 1= very unsatisfied (worst), 2= unsatisfied, 3= neutral, 4= satisfied or 5= very satisfied (best). The percentage of participants who rated their satisfaction as satisfied or very satisfied at Month 4 is reported."|Month 4|ITT Population included all randomized participants.|||percentage of participants|||Number
2647045|NCT01698554|Secondary|Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).|Baseline, Month 4|Participants from the ITT Population, all randomized participants, with data available for analysis.|||intensity units||Standard Deviation|Mean
2647046|NCT01698554|Secondary|Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was measured in millimeters squared (mm^2). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated fuller eyelashes (improvement).|Baseline Month 4|Participants from the ITT Population, all randomized participants, with data available for analysis.|||mm^2||Standard Deviation|Mean
2647047|NCT01698554|Secondary|Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA)|Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement)|Baseline, Month 4|Participants from the ITT Population, all randomized participants, with data available for analysis.|||mm||Standard Deviation|Mean
2647048|NCT01698554|Primary|Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA)|The investigator evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.|Baseline, Month 4|Intent-to-treat (ITT) Population included all randomized participants.|||percentage of participants|||Number
2647049|NCT01698528|Secondary|Time Health Care Providers and Subjects Spend on Managing the Insulin Titration|time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes|3 months||||min||Standard Deviation|Mean
2647050|NCT01698528|Secondary|Number of Participants With Hypoglycemia|Number of participants had hypoglycemia during the trial period|3 months||||Participants|||Count of Participants
2647051|NCT01698528|Secondary|Change in Average Participation Satisfaction|The volunteer's satisfaction with their diabetes care will be measured at the beginning and at the end of the study. Diabetes Treatment Satisfaction Questionnaire (DTSQ) was used for assessing the satisfactory level. DTSQ consisted of 8 questions, each question with a score scale of 0-6 (very dissatisfied to very satisfied), leading to a final score range of 0-48, with higher scores indicating greater satisfaction. The change in the DTSQ comparing before (time 0) and end of the study (t=3months) was measured. The average change in the intervention group and control group were listed in the outcome measure data table.|3 months||||Scores on a scale||Standard Deviation|Mean
2647052|NCT01698528|Secondary|Number of Participants Reaching Target of HbA1c ≤ 7%|Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.|3 months||||Participants|||Count of Participants
2647053|NCT01698528|Primary|Glycemic Control as Determined by the Change in Absolute HbA1c Level|The primary outcome of interest is absolute decrease in A1c by end of 3 months.|3 months||||Percent A1C||Standard Deviation|Mean
2647054|NCT01698502|Secondary|The Total Glucose-dependent Insulinotropic Peptide (GIP) Response Measured as Area Under the GIP Curve (AUC GIP).|Comparison of the total release of GIP during the 3 hour OGTT and IIGI.|Test day 1 and 2 within 7 days.||||pmol/L * 210 min||Standard Error|Mean
2647055|NCT01698502|Primary|Incretin Effect (the % of Insulin Secreted Due to the Release of the Intestinal Hormones Glucagon Like Peptide-1 (GLP-1 and Glucose-dependent Insulinotropic Peptide (GIP))|The Incretin effect (the % of insulin secreted due to the release of the intestinal hormones GLP-1 and GIP) is calculated as the difference between the insulin concentration during a 3 hour oral glucose tolerance test (OGTT) (day 1) compared to a 3 hour isoglycemic intravenous glucose infusion (IIGI) (day 2) that has similar glucose excursions.|Test day 1 and 2 within 7 days.||||percentage||Standard Error|Mean
2647056|NCT01698463|Secondary|Health Related Quality of Life (HRQOL)|The EQ-5D-5L questionnaire will be used to assess health related quality of life at baseline and at six weeks follow-up. The EQ-5D-5L questionnaire is very short and easy to complete making it ideal for a busy clinical setting. It consists of five questions which ask about pain, depression, activities, self-care and mobility. 0 (represents best performance) to 25 (represents worst performance).|Baseline, 6 week follow-up||||units on a scale||Standard Deviation|Mean
2649529|NCT01676701|Secondary|Percent Change From Baseline to 12-Week Endpoint in American College of Rheumatology (ACR-N) Index||Baseline, Week 12|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
2647057|NCT01698463|Secondary|Behavior Change Outcome: Intentions|"A psychometric questionnaire will assess intentions using a likert scale at baseline and 6 weeks follow-up.~Intentions: assesses an individuals intention to engage in recommended exercises. Psychometric questionnaire assessing Intentions was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 15 (best performance)."|Baseline, 6 week follow-up||||units on a scale||Standard Deviation|Mean
2647058|NCT01698463|Secondary|Behavior Change Outcome: Coping Self-Efficacy|"A psychometric questionnaire will assess coping self-efficacy using a likert scale at baseline and 6 weeks follow-up.~Coping Self-Efficacy: assesses an individuals belief in their ability to overcome barriers. Psychometric questionnaire assessing Coping Self-Efficacy was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 45 (best performance)."|Baseline, 6 week follow-up||||units on a scale||Standard Deviation|Mean
2647059|NCT01698463|Secondary|Behavior Change Outcome: Coping Planning|"A psychometric questionnaire will assess coping planning using a likert scale at baseline and 6 weeks follow-up.~Coping Planning: assesses an individuals ability to overcome perceived barriers e.g. lack of time, poor weather. Psychometric questionnaire assessing coping planning was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 20 (best performance)."|Baseline, 6 week follow-up||||units on a scale||Standard Deviation|Mean
2647060|NCT01698463|Secondary|Behavior Change Outcome: Action Planning|"A psychometric questionnaire will assess action planning using a likert scale at baseline and 6 weeks follow-up.~Action Planning: when, where and how an individual will engage in the recommended exercise. Psychometric questionnaire assessing Action Planning was administered at baseline and follow-up. The psychometric questionnaire used a 5 point likert scale. (0 represents worst performance) to 25 (best performance)."|Baseline, 6 week follow-up||||units on a scale||Standard Deviation|Mean
2647061|NCT01698463|Primary|Physical Activity (Self-report) (Reporting Change in Physical Activity From Baseline to Six-week Follow-up)|Participants complete a physical activity log book daily in order to document their completion of the prescribed exercises and list any additional activities that they may have been engaged in. The percentage of prescribed exercises completed are reported (for e.g. if participants completed 2 of 3 prescribed exercise then the reported percentage would be 67%). Mean (SD) are reported.|Baseline, 6 week follow-up||||percentage of completed exercise||Standard Deviation|Mean
2647062|NCT01698463|Primary|Physical Activity (Reporting Change in Physical Activity From Baseline to Six-week Follow-up)|The X2-Mini accelerometer (Gulf Coast Data Concepts.,USA) is a three-dimensional sensor that is used to capture the activity levels of an individual. The accelerometer is worn on the hip of the participant for four days. The number of minutes that the individual spends in each exercise intensity category is acquired. Accelerometer thresholds make up four categories of activity: (1) sedentary; (2) low-light; (3) high-light; (4) moderate-vigorous. Activity monitors have been indicated as the most accurate means of measuring physical activity levels.|Baseline, 6 week follow-up||||minutes/day||Standard Deviation|Mean
2647063|NCT01698333|Primary|Hypothalamic-Pituitary-Adrenal (HPA) Axis Response|"HPA axis response to stimulation by cosyntropin, dichotomized to normal and abnormal. Laboratory evidence of abnormal HPA axis response is defined as a 30-minute post-stimulation serum cortisol level that is ≤ 18 μg/dL at the end of study."|Day 15|Analysis shown is based on the ITT population, defined as all enrolled participants who applied at least one dose of the test article and returned for at least one post-Baseline visit.|||Participants|||Count of Participants
2647064|NCT01698320|Primary|Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52|"The physical exam was performed by a qualified healthcare professional, and when possible, the same qualified healthcare professional that performed the physical examination at study screening performed all the scheduled physical examinations. Abnormalities and clinical relevance were determined by the qualified healthcare professional.~HEENT = head, eyes, ears, nose, throat"|Weeks 0, 12 and 52|Safety population. Participants with assessments at each time point are reported.|||participants|||Number
2647065|NCT01698320|Primary|Change From Baseline in Pulse Measurements to Week 12 and Week 52|"Participants were seated at least 2 minutes before pulse measurements were obtained by radial pulse.~Week 12 values represent change from Week 0. Week 52 values represent change from Week 12."|Week 0, Week 12 and Week 52|Safety population. Participants with assessments at each time point are reported.|||beats/minute||Standard Deviation|Mean
2647066|NCT01698320|Primary|Change From Baseline in Blood Pressure Measurements to Week 12 and Week 52|"Participants were seated at least 2 minutes before blood pressure measurements were obtained by either an electronic or manual sphygmomanometer.~Week 12 values represent change from Week 0. Week 52 values represent change from Week 12."|Week 0, Week 12 and Week 52|Safety population. Participants with assessments at each time point are reported.|||mmHg||Standard Deviation|Mean
2647067|NCT01698320|Primary|Electrocardiogram (ECG) Results At Weeks 0, 12, and 52|A standard 12-lead ECG was performed at screening, week 12, and week 52 or early termination/discontinuation. The ECG recording methods were centralized and standardized across all study participants. A centralized cardiologist was responsible for providing all ECG interpretations.|Weeks 0 (screening visit), 12, and 52|Safety population. Participants with assessments at each time point are reported.|||participants|||Number
2647068|NCT01698320|Primary|Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period)|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Weeks 13-52|Safety population|||participants|||Number
2647436|NCT01694420|Primary|Virologic Efficacy of the Fixed Dose Combination (FDC) ELV/COBI/FTC/TDF Given Once Daily to Participants With Acute HIV Infection as Determined by the Proportion of Treated Participants With HIV-1 RNA to <50 Copies/mL at Week 48||48 weeks||||participants|||Number
2647070|NCT01698320|Other Pre-specified|Device Invitro Evaluations to Week 52|"Device In Vitro Evaluations - All used study inhalers will be collected and a random selection of inhalers will be tested as follows:~Fifty (50) Albuterol Spiromax® inhalers used during weeks 0-12 will be randomly selected for in vitro testing~Fifty (50) Albuterol Spiromax® inhalers used during weeks 12-52 will be randomly selected for in vitro performance testing"|Baseline to Week 52|||||||
2647071|NCT01698320|Other Pre-specified|Composite Measurement of Device Ruggedness From Baseline to Week 52|Device Ruggedness: Reports of any problems/malfunction of the device (e.g., lack of efficacy, problems/malfunction after the device is dropped or sustains physical impact).|Baseline to Week 52|||||||
2647072|NCT01698320|Primary|Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period)|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 12|Safety population|||participants|||Number
2647073|NCT01698268|Primary|FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC)|FLACC: Face, Legs, Activity, Cry, and Consolability Pain Assessment Scale (FLACC), a five-item, three point scale that measures pain behavior on a scale of 0 - 2 which are summed to result in a total score of 0 - 10. Clinical judgment is used to interpret pain. The higher the score on the FLACC correlates with a higher pain score (0= no behaviors indicative of pain and 10= five behaviors indicative of significant pain). This scale was evaluated by blinded post-operative anesthesia care unit (PACU) Registered Nurses (RNs) at admission to PACU.|Admission into PACU||||units on a scale||Inter-Quartile Range|Median
2647074|NCT01698008|Primary|Evidence for Improved Diabetic Care With Mobile Phone Application Use|Satisfaction and usability was evaluated with a survey for those subjects who used the mobile phone application at the 3 and 6 months period.|Six months||||Participants|||Count of Participants
2647075|NCT01697969|Primary|Patient-Assessed Ocular Itching|The patient rated the severity of ocular itching using a predetermined 0-4 scale, where 0=none and 4=severe itching with irresistible urge to rub. Each eye was rated separately. A 2-week washout period from prior allergy medication (if applicable) preceded the baseline assessment.|Baseline (Day 1), Day 14|The analysis population includes all participants exposed to the test product. Here, “n” is the number of participants with non-missing values at the specific time point.|||units on a scale||Standard Deviation|Mean
2647076|NCT01697956|Secondary|Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study|"Shifting to 'High' refers to starting the study within normal range and being outside the high-end of normal by end of study. Conversely, shifting to 'Low' refers to starting the study within normal range and being outside the low-end of normal by end of study.~BUN = blood urea nitrogen AST = aspartate transaminase ALT = alanine transaminase GGT = gamma-glutamyl transpeptidase"|Screening (Day -21 to -7), End of Study (Day 42)|Safety population|||participants|||Number
2647077|NCT01697956|Secondary|Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study|"Shifting to 'High' refers to starting the study within normal range and being outside the high-end of normal by end of study. Conversely, shifting to 'Low' refers to starting the study within normal range and being outside the low-end of normal by end of study.~MCHC = mean corpuscular hemoglobin concentration MCV = mean corpuscular volume, or mean cell volume MCH = mean corpuscular hemoglobin or mean cell hemoglobin"|Screening (Day -21 to -7), End of Study (Day 42)|Safety population|||participants|||Number
2647078|NCT01697956|Secondary|Participants With Treatment-Emergent Adverse Events (AEs)|"The intensity or severity of the AE was characterized as mild (AE which is easily tolerated), moderate (AE sufficiently discomforting to interfere with daily activity) or severe (AE which prevents normal daily activities).~The causal relationship was characterized as not related (no reasonable possibility that the AE was caused by or attributed to the investigational product) or related reasonable possibility that the AE was caused by or attributed to the investigational product / a causal relationship cannot be ruled out).~An SAE was defined as an AE that resulted in any of the following:~Death~Life-threatening~Required hospitalization or prolonged existing hospitalization~Persistent or significant disability or incapacity~A congenital abnormality or birth defect~An important medical event which required medical intervention to prevent any of the above outcomes."|Day 1- week 10|Safety population which included all randomized participants who received at least one dose of randomized study medication.|||participants|||Number
2647079|NCT01697956|Secondary|Terminal Elimination Half-life (t1/2) for Beclomethasone-17-monopropionate (17-BMP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Due to the short duration of measurable BDP concentrations in plasma, t1/2 for BDP could not be estimated for any participants.|||hours||Standard Deviation|Mean
2647080|NCT01697956|Secondary|Terminal Elimination Rate Constant (λz ) for Beclomethasone-17-monopropionate (17-BMP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Due to the short duration of measurable BDP concentrations in plasma, λz for BDP could not be estimated for any participants.|||1/hour||Standard Deviation|Mean
2647437|NCT01694420|Primary|Number of Participants With a Viral Load Measurement of <200 Copies/mL at Week 24||24 weeks||||participants|||Number
2647081|NCT01697956|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Plasma BDP concentrations were generally low and were only measurable over a short period of time.|||hours||Standard Deviation|Mean
2647082|NCT01697956|Secondary|Maximum Plasma Concentration (Cmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day.|||pg/mL||Standard Deviation|Mean
2647083|NCT01697956|Secondary|Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day. Plasma BDP concentrations were generally low and were only measurable over a short period of time.|||h*pg/mL||Standard Deviation|Mean
2647084|NCT01697956|Secondary|Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-t ) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)|Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics.|Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)|Per protocol population of participants administered BDP nasal aerosol 80 mcg/day|||h*pg/mL||Standard Deviation|Mean
2647085|NCT01697956|Primary|Change From Baseline (Expressed As A Ratio) In 24-Hr Serum Cortisol Weighted Mean Following 6 Weeks Of Treatment|The serum cortisol weighted mean (0-t), calculated by dividing the area under the concentration-time curve (AUC) from time zero to the time of the last measurable value over the 24-hour period by the sample collection time interval, was determined for each participant at baseline and Week 6, and the ratio of Week 6 over baseline was derived.|Baseline (Day 1, -24, -22, -20, -16, -12, -8, and 0 hours prior to study medication), End of Treatment (Day 43, (Immediately prior to study medication administration (Hour 0) and at 2, 4, 8, 12, 16, and 24 hours after study medication administration)|Per protocol (PP) population|||ratio||Standard Error|Geometric Mean
2647086|NCT01697800|Primary|Change in Immune Response After Tadalafil Administration||Baseline and 120-150 Days|Blood samples were collected. However, the samples were not analyzed and hence no data were generated.||||||
2647087|NCT01697748|Other Pre-specified|The Number of Participants Noting Pain at the Six Weeks Post Cesarean Visit|Pain response to notable pain at wound site during 6 week post operative visit Subjective self reporting of pain as yes or no.|6 weeks post operative||||Participants|||Count of Participants
2647088|NCT01697748|Other Pre-specified|The Number of Participants Noting Pain at the One Week Post Cesarean Visit|Pain response to notable pain at wound site during 7 day post operative visit Subjective self reporting pain as yes or no.|Post operative day 7|This was the number of participants that completed the form at their 7 day post- operative visit.|||Participants|||Count of Participants
2647089|NCT01697748|Other Pre-specified|Reduction of Pain After Cesarean Delivery|The amount of narcotics measured in Morphine equivalent milligrams and non opioids administered during the cesarean delivery hospitalization were recorded|Immediately post operatively to hospital discharge||||Morphine milligram equivalent||Inter-Quartile Range|Median
2647090|NCT01697748|Secondary|Cosmetic Outcome of the Cesarean Section Incision|"The following instruments will be used to determine the cosmetic outcome~• The Modified Observer Scar Assessment Scale Range of scale values is from 5 - 50 ( the lower the score the better the outcome)"|Six weeks post-operative||||score on a scale||Standard Deviation|Mean
2647091|NCT01697748|Secondary|Cosmetic Outcome of the Cesarean Section Incision|"The following instruments will be used to determine the cosmetic outcome:~• The Modified Vancouver scar scale Range of scale values are from 0-12 (0 indicating a better outcome)"|Post operative day 7||||score on a scale||Standard Deviation|Mean
2647092|NCT01697748|Primary|Percentage of Patients Who Develop a Surgical Site Infection|"A surgical site infection involving the skin and subcutaneous tissue is defined as either~The presence of a purulent discharge from the wound on inspection, or~Purulent discharge obtained from the wound after exploration based on the suspicion of the provider (erythema, swelling, heat or pain), or~The presence of a seroma or hematoma discharge from the wound on inspection or after exploration that also involves isolation of an organism from an aseptically obtained culture based on suspicion of the provider (erythema, swelling, heat or pain). Seromas or hematomas with negative cultures will not be considered a surgical site infection."|from post operative day #1 through post operative day 30||||Participants|||Count of Participants
2647093|NCT01697709|Primary|Number of Participants Stratified by Marijuana Abstinence Days Per Week|The number of abstinent days per week over the 12 weeks of study as recorded by the Timeline Followback method. High Use group defined as 0-2 abstinent days per week, Medium Use Group as 3-5 abstinent days per week and Low Use Group as 6-7 abstinent days per week.|12 weeks or length of participation|participants were included in the weekly analysis who were still active in the trial at each given week.|||Participants|||Count of Participants
2649530|NCT01676701|Secondary|Percentage of Participants Achieving ACR Response||Week 12|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
2647095|NCT01697696|Secondary|Time to First COPD Exacerbation (Moderate or Severe).|COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if hospitalizations were required. Rates are calculated using the Kaplan Meier method.|52 weeks|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Patients were analyzed according to the treatment to which they were randomized|||Days||95% Confidence Interval|Median
2647096|NCT01697696|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication|The number of puffs of rescue medication taken in the previous 12 hours was recorded by the patients in the eDiary in the morning and evening. The total number of puffs of rescue medication per day over the 52 week treatment period was calculated and divided by the total number of days with non-missing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient. If the number of puffs was missing for part of the day (either morning or evening), then a half day was used in the denominator. Change from baseline in number of puffs were analyzed using a linear mixed model which contained treatment, baseline number of puffs, baseline smoking status, baseline ICS use and COPD disease severity as fixed effects with center as a random effect|52 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Number of puffs||Standard Error|Least Squares Mean
2647097|NCT01697696|Secondary|Change From Baseline in COPD Symptoms|Percentage of days with 'no daytime symptoms' A day with 'no daytime symptoms' was defined from the diary data as any day where the patient had recorded in the evening no cough, no wheeze, no production of sputum and no feeling of breathlessness (other than when running) and no puffs of rescue medication during the past 12 hours (approximately 8 am to 8pm). However, a patient was not considered symptom free if they had used rescue medication that day even if his/her total daytime symptoms score was zero. Percentage of nights with 'no nighttime awakenings' A night with 'no nighttime awakenings' was defined from diary data as any night where the patient did not wake up due to symptoms. The total number of nights with 'no nighttime awakenings' over the treatment period was divided by the total number of nights where diary recordings had been made in order to derive the percentage nights with 'no nighttime awakenings'.|52 weeks|Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Percentage of days / nights||Standard Error|Least Squares Mean
2647098|NCT01697696|Secondary|Change From Baseline in COPD Symptoms|The total symptom score was defined as the sum of individual cores for respiratory symptoms, cough, wheeze, amount of sputum, color of sputum, and reathlessness. Where a patient had a morning score and an evening score for an individual symptom on one particular day then the worst score was to be taken as the daily score for that symptom. Each symptom scale ranged from 0-3 where 0 was no symptoms and 3 was the worst. The total daily/daytime/nighttime symptom score consists of looking at the score for 6 symptoms and can therefore have a minimum score of 0 or a maximum of 18.|52 weeks|Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.”|||scores on a scale||Standard Error|Least Squares Mean
2647099|NCT01697696|Secondary|Change From Baseline in Pre-dose Forced Vital Capacity (FVC) at All Post-baseline Timepoints|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FVC was defined as the average of the pre-dose FVC measured at -45 minutes (min) and -15 min at day 1.|-45 min and -15 minutes baseline and at Week 52|Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Only participants with baseline and specific post baseline time points were included in the analysis for that time point.|||Liters||Standard Deviation|Mean
2647100|NCT01697696|Secondary|Change From Baseline in Pre-dose Forced Expiratory Volume (FEV1) in One Second at All Post Baseline Timepoints|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1.|-45 min and -15 minutes baseline and at Week 52|The Full Analysis set (FAS). At each day/time point, only subjects with a value at both baseline and the respective day/time point are included. Only participants with baseline and specific post baseline time points were included in the analysis for that time point.|||Liters||Standard Deviation|Mean
2647101|NCT01697696|Secondary|Change From Baseline in Mean Forced Expiratory Volume (Average of the Two FEV1 Measurements 45 and 15 Minutes Pre-dose) in One Second at Week 52|Change from baseline in pre-dose trough FEV1 was analyzed using a repeated measures analysis of covariance model which contained treatment, baseline FEV1, visit, baseline smoking status, baseline ICS use, COPD severity and treatment by visit, visit by baseline FEV1 interactions. An unstructured variance-covariance error matrix was used .Pulmonary function assessments were performed using centralized spirometry according to international standards. Pre-dose trough FEV1 was defined as the mean of FEV1 at -45 min and -15 min before the morning dose at Week 52. Baseline FEV1 was defined as the mean of the pre-dose FEV1 at -45 min and -15 min on Day 1.|-45 min and -15 minutes baseline and at Week 52|The Full Analysis set (FAS) included patients who received at least one dose of study medication. Patients were analyzed according to the treatment to which they were randomized. Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Liters||Standard Error|Least Squares Mean
2647102|NCT01697696|Secondary|Time to Treatment Discontinuation|Discontinuation rates are calculated using the Kaplan Meier method. The protocol allowed patients to discontinue outside the treatment window, hence we have a patient who discontinued at Day 388. Reasons for discontinuing treatment are Subject/guardian decision, Adverse event, Protocol deviation Lack of efficacy, Physician decision, Dosing error, Disease improvement under study, Pregnancy, Technical problems|52 Weeks|The Safety set consisted of all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received.|||Days||95% Confidence Interval|Median
2647408|NCT01694771|Primary|Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12|Trough FEV1 (Forced expiratory volume in 1 second) response at 12 weeks; defined as change from baseline to Week 12|baseline and 12 weeks|Full Analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.|||L||Standard Error|Least Squares Mean
2647103|NCT01697696|Primary|Percentage of Participants Reporting Safety and Tolerability in Terms of Adverse Event (AE) Reporting Rate|Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.|52 weeks|Safety population - all patients who received at least one dose of study drug whether or not they were randomized. Only patients with safety assessments were included in this analysis|||Percentage of participants|||Number
2647104|NCT01697592|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24|HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 HbA1c minus the Week 0 HbA1c.|Baseline and Week 24|Full Analysis Set (FAS), comprised of all participants who received at least one study drug and have a baseline or post-randomization measurement.|||Percent HbA1C||95% Confidence Interval|Least Squares Mean
2647105|NCT01697592|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.|Up to 52 weeks|The ASaT population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. Data was unavailable for 5 participants who discontinued from the study in the placebo arm in Phase A.|||Percentage of participants|||Number
2647106|NCT01697592|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 24 weeks|The ASaT population was defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.|||Percentage of Participants|||Number
2647107|NCT01697592|Primary|Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During the Overall Study|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue). These results represent the accrual of events over different treatment intervals: 52 weeks, Omarigliptin (Phase A+B) group, defined as the double-blind period and open-label extension period versus 28 weeks for the placebo switching to Omarigliptin group defined as the open-label extension period only.|Up to 52 weeks|The ASaT population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data. Data was unavailable for 5 participants who discontinued from the study in the placebo arm in Phase A.|||Percentage of participants|||Number
2647108|NCT01697592|Primary|Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue During Phase A|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. Glycemic rescue criteria were: fasting plasma glucose (FPG) of >240 mg/dL, 2 times, (Week 4 to Week 24) and after Week 24, FPG >200 mg/dL, 2 times. Glycemic rescue was achieved through up-titration of basal medication (1st rescue) and through the use of metformin or glimepiride (2nd rescue).|Up to 24 weeks|All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data using the ASaT population.|||Percentage of participants|||Number
2647109|NCT01697579|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycles 2-6|AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.|Up to 14 days postdose for each cycle (Cycles 2-6)|All randomized participants who received at least one dose of study treatment in Cycles 2-6.|||Percentage of participants|||Number
2647110|NCT01697579|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycle 1|AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.|Up to 14 days postdose in Cycle 1|All randomized participants who received at least one dose of study treatment in Cycle 1.|||Percentage of participants|||Number
2647111|NCT01697579|Primary|CL/F of Aprepitant in Participants 12 to 17 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||mL/min||Standard Deviation|Mean
2647112|NCT01697579|Primary|C48hr of Aprepitant in Participants 12 to 17 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.|Approximately 48 hours (from 46 to 50 hours) post-infusion|All participants 12 to 17 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.||||||
2647113|NCT01697579|Primary|C24hr of Aprepitant in Participants 12 to 17 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.|Approximately 24 hours (from 23 to 25 hours) post-infusion|All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
2647114|NCT01697579|Primary|t1/2 of Aprepitant in Participants 12 to 17 Years of Age Hours|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hours||Standard Deviation|Mean
2647115|NCT01697579|Primary|AUC 0-24hr of Aprepitant in Participants 12 to 17 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hr•ng/mL||Standard Deviation|Mean
2647116|NCT01697579|Primary|AUC 0-∞ of Aprepitant in Participants 12 to 17 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hr•ng/mL||Standard Deviation|Mean
2647117|NCT01697579|Primary|Tmax of Aprepitant in Participants 12 to 17 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hours||Standard Deviation|Mean
2647118|NCT01697579|Primary|Cmax of Aprepitant in Participants 12 to 17 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
2647119|NCT01697579|Primary|CL/F of Aprepitant in Participants 6 to <12 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||mL/min||Standard Deviation|Mean
2647120|NCT01697579|Primary|C48hr of Aprepitant in Participants 6 to <12 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.|Approximately 48 hours (from 46 to 50 hours) post-infusion|All participants 6 to <12 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
2647121|NCT01697579|Primary|C24hr of Aprepitant in Participants 6 to <12 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.|Approximately 24 hours (from 23 to 25 hours) post-infusion|All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
2647122|NCT01697579|Primary|t1/2 of Aprepitant in Participants 6 to <12 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hours||Standard Deviation|Mean
2647123|NCT01697579|Primary|AUC 0-24hr of Aprepitant in Participants 6 to <12 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hr•ng/mL||Standard Deviation|Mean
2647124|NCT01697579|Primary|AUC 0-∞ of Aprepitant in Participants 6 to <12 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hr•ng/mL||Standard Deviation|Mean
2647125|NCT01697579|Primary|Tmax of Aprepitant in Participants 6 to <12 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hours||Standard Deviation|Mean
2647126|NCT01697579|Primary|Cmax of Aprepitant in Participants 6 to <12 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 6 to <12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
2647127|NCT01697579|Primary|CL/F of Aprepitant in Participants 2 to <6 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||mL/min||Standard Deviation|Mean
2647128|NCT01697579|Primary|C48hr of Aprepitant in Participants 2 to <6 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.|Approximately 48 hours (from 46 to 50 hours) post-infusion|All participants 2 to <6 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
2647129|NCT01697579|Primary|C24hr of Aprepitant in Participants 2 to <6 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.|Approximately 24 hours (from 23 to 25 hours) post-infusion|All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
2647130|NCT01697579|Primary|t1/2 of Aprepitant in Participants 2 to <6 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hours||Standard Deviation|Mean
2647131|NCT01697579|Primary|AUC 0-24hr of Aprepitant in Participants 2 to <6 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hr•ng/mL||Standard Deviation|Mean
2647132|NCT01697579|Primary|AUC 0-∞ of Aprepitant in Participants 2 to <6 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hr•ng/mL||Standard Deviation|Mean
2647133|NCT01697579|Primary|Tmax of Aprepitant in Participants 2 to <6 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hours||Standard Deviation|Mean
2647134|NCT01697579|Primary|Cmax of Aprepitant in Participants 2 to <6 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 2 to <6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
2647135|NCT01697579|Primary|Apparent Total Body Clearance (CL/F) of Aprepitant in Participants 0 to <2 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||mL/min||Standard Deviation|Mean
2647136|NCT01697579|Primary|Concentration of Aprepitant After 48 Hours (C48hr) in Participants 0 to <2 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.|Approximately 48 hours (from 46 to 50 hours) post-infusion|All participants 0 to <2 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
2647137|NCT01697579|Primary|Concentration of Aprepitant After 24 Hours (C24hr) in Participants 0 to <2 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.|Approximately 24 hours (from 23 to 25 hours) post-infusion|All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
2647138|NCT01697579|Primary|Apparent Terminal Half-life (t1/2) of Aprepitant in Participants 0 to <2 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hours||Standard Deviation|Mean
2647139|NCT01697579|Primary|Area Under the Concentration-time Curve of Aprepitant From Time 0 to 24 Hours (AUC 0-24hr) in Participants 0 to <2 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hr•ng/mL||Standard Deviation|Mean
2647140|NCT01697579|Primary|Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC 0-∞) in Participants 0 to <2 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hr•ng/mL||Standard Deviation|Mean
2647141|NCT01697579|Primary|Time to Maximum Concentration (Tmax) of Aprepitant in Participants 0 to <2 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||hours||Standard Deviation|Mean
2647142|NCT01697579|Primary|Maximum Concentration (Cmax) of Aprepitant in Participants 0 to <2 Years of Age|Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.|Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion|All participants 0 to <2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.|||ng/mL||Standard Deviation|Mean
2647143|NCT01697501|Secondary|Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF||EoT and EoF|FAS|||percentage of participants|||Number
2647144|NCT01697501|Secondary|Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF||EoT and EoF|Full analysis set (FAS), defined as all subjects who completed|||percentage of participants|||Number
2647145|NCT01697501|Secondary|Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF||EoT and EoF|FAS|||percentage of participants|||Number
2647146|NCT01697501|Secondary|Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF||EoT and EoF|Full analysis set (FAS), defined as all subjects who completed|||percentage of participants|||Number
2647147|NCT01697501|Secondary|Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT||EoT|FAS|||percentage of participants|||Number
2647148|NCT01697501|Secondary|Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)||EoT, as defined in the predecessor study, was at Week 48 or Week 96|Full analysis set (FAS), defined as all subjects who completed|||percentage of participants|||Number
2647149|NCT01697501|Primary|Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF||EoF|FAS|||percentage of participants|||Number
2647150|NCT01697501|Primary|Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF)||EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.|Full analysis set (FAS), defined as all subjects who completed|||percentage of participants|||Number
2647151|NCT01697462|Secondary|Number of Participants With Hand-Foot Syndrome (HFS)|HFS, also called palmar-plantar erythrodysesthesia, is a side effect or toxicity associated with specific chemotherapy treatments. The National Cancer Institute (2010) describes it as a condition marked by pain, swelling, numbness, tingling, or redness of the hands or feet.|Baseline up to end of study (up to 42 months)|ITT population.|||Participants|||Number
2647152|NCT01697462|Secondary|Progression-Free Survival (PFS)|PFS was defined as the period from study entry until disease progression or death from any cause. Disease progression was defined as greater than 20% increase in sum of longest diameter of target lesions compared to baseline.|Baseline to progressive disease or death (up to 42 months)|ITT population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.|||Months||95% Confidence Interval|Median
2671368|NCT01476748|Secondary|Trocar Slippages Without LaproStop|Number of participants with slippages with LaproStop|During the hysterectomy procedure, up to 2 hours and 32 minutes||||Participants|||Number
2647153|NCT01697462|Secondary|Percentage of Participants With Disease Progression|Disease progression was defined as greater than 20 percent (%) increase in sum of longest diameter of target lesions compared to baseline.|Baseline to progressive disease or death (up to 42 months)|ITT population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.|||Percentage of participants|||Number
2647154|NCT01697462|Primary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs.|Baseline up to end of study (up to 42 months)|Intent-to-treat (ITT) population included all participants who received at least one dose of the study drug and had a subsequent post baseline assessment.|||Participants|||Number
2647155|NCT01697449|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of informed consent until the date when the participant had progression of disease or died due to any cause. Participants who left the study for reasons other than progression of the disease were censored at the time of their last tumor assessment. Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.|Up to 65 months|Included participants who received at least 1 dose of study drug and had postbaseline tumor assessment.|||months||95% Confidence Interval|Median
2647156|NCT01697449|Secondary|Percentage of Participants With Disease Progression or Death|Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.|Up to 65 months|Included participants who received at least 1 dose of study drug and had postbaseline tumor assessment.|||percentage of participants|||Number
2647157|NCT01697449|Secondary|Percentage of Participants Who Were Resectable Postbaseline Among the Participants Who Were Unresectable at Baseline||Up to 65 months|Included participants whose CRC was identified as unresectable at baseline.|||percentage of participants|||Number
2647158|NCT01697449|Secondary|Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST)|Per RECIST, CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR was defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.|Up to 65 months|All participants who received at least 1 dose of study drug were included in this analysis.|||percentage of participants|||Number
2647159|NCT01697449|Primary|Percentage of Participants With At Least One Adverse Event (AE)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|Up to 65 months|All participants who received at least 1 dose of study drug and underwent subsequent safety assessment were considered for the safety analysis.|||percentage of participants|||Number
2647160|NCT01697358|Other Pre-specified|Compare Proportion of Subjects With ≥30% Reduction in Low Back Pain Intensity Between the Treatment Groups|This additional analysis was pre-specified to support the analysis of primary objective. The 30% responder which is defined in the following paragraph was considered as clinical relevant to the SCS therapy in back pain. Compare the proportion of subjects with a ≥30% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥30% reduction in average low back pain were considered as 30% responders.|6 months post randomization|As-treated - included all randomized subjects who provided data at 6-month visit, and analyzed based on the actual treatment the subjects received at 6-month visit.|||Participants|||Count of Participants
2647161|NCT01697358|Secondary|Compare Change in Quality of Life (QoL), as Measured by the SF-36 Physical Component Summary (PCS), Between the Treatment Groups|The QoL scores were collected using the SF-36 questionnaire, which included the scores in the following 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health. The raw score of 0 represents poor health and 100 represents best health. The Physical Component Summary (PCS) score is a norm based score calculated from the raw scores of these 8 domains with a focus on physical health using 1998 US population. Change in PCS is calculated as PCS at 6-month visit - PCS at baseline, with a positive change indicated as an improvement.|6 months post randomization|Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.|||units on a scale||Standard Deviation|Mean
2647192|NCT01696994|Secondary|Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test|Number of positive screens with complications|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 3 positive screens with documented follow-up after each one, she would be counted 3 times in the number of units analyzed.|||Positive screens w/ complications|Positive Screens with Follow-up||Number
2647162|NCT01697358|Secondary|Compare Change in Functional Disability, as Measured by the Oswestry Disability Index (ODI), Between the Treatment Groups|ODI is a validated questionnaire of 10 subject-reported sections on the ability to perform activities of daily living. These 10 sections are pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life (if applicable), social life, and traveling. Each section was scored on a 0 to 5 scale with 0 indicating no limitation of function due to pain and 5 indicating major functional disability due to back pain. A raw ODI score was calculated from the total score of 10 sections (minimum is 0 and maximum is 50). This ODI raw score was then normalized to a scale of 0 to 100, with 0-20 categorized as minimal disability, 20-40 as moderate disability, 40-60 as severe disability, 60-80 as severely disabled, and 80-100 as bed-bound patients. The ODI was assessed at baseline and subsequent scheduled study visits. Change in functional disability is calculated as ODI at baseline - ODI at 6-month visit, with a positive change indicated as an improvement.|6 months post randomization|Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.|||units on a scale||Standard Deviation|Mean
2647163|NCT01697358|Secondary|Compare Change in Leg Pain Intensity, as Measured by the NPRS, Between the Treatment Groups|Compare change in leg pain intensity, as measured by the NPRS, from baseline to the end of Period I for subjects in the SCS group with that in the OMM group. Subjects reported average leg pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Change in leg pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.|6 months post randomization|Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.|||units on a scale||Standard Deviation|Mean
2647164|NCT01697358|Secondary|Compare Change in Low Back Pain Intensity, as Measured by the Numeric Pain Rating Scale (NPRS), Between the Treatment Groups|Compare change in low back pain intensity, as measured by the Numeric Pain Rating Scale (NPRS), from baseline to the end of Period I for subjects in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Change in low back pain intensity is calculated as NPRS at baseline - NPRS at 6-month visit, with a positive change indicated as an improvement.|6 months post randomization|Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as having no change.|||units on a scale||Standard Deviation|Mean
2647165|NCT01697358|Primary|Compare Proportion of Subjects With ≥50% Reduction in Low Back Pain Intensity Between the Treatment Groups|Compare the proportion of subjects with a ≥50% reduction in low back pain intensity, as measured by the NPRS, from baseline to the end of Period I in the SCS group with that in the OMM group. Subjects reported average low back pain using a 11-point NPRS pain diary (0 = no back pain, 10 = worst low back pain imaginable) two times per day for a 7-day period at baseline and prior to 6-month visit. Percent reduction in low back pain intensity was calculated as average NPRS at (6-month visit - baseline) / baseline. Subjects with ≥50% reduction in average low back pain were considered as responders.|6 months post randomization|Intent-to-treat (ITT) - included all randomized subjects and analyzed as randomized, regardless the subjects' status at 6 months. Subjects in the SCS+OMM group received screening tests after the randomization, and might not have proceeded to implant of the neurostimulator. Subjects with missing data at 6 months were imputed as non-responders.|||Participants|||Count of Participants
2647166|NCT01697345|Secondary|Number of Participants Who Continued Vaginal Testosterone Upon Completion of the Study||After 4 weeks||||participants|||Number
2647167|NCT01697345|Primary|FSFI Pain Domain|The score for pain is calculated by adding the individual scores from the pain domain (question #17, #18, #19) and multiplying the sum by the domain factor of 0.4. The domain score for pain ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
2647168|NCT01697345|Primary|FSFI Satisfaction Domain|The satisfaction score is calculated by adding the individual scores from the satisfaction domain (question #14, #15, #16) and multiplying the sum by the domain factor of 0.4. The satisfaction domain score ranges from 0.8 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
2647169|NCT01697345|Primary|FSFI Orgasm Domain|The orgasm score is calculated by adding the individual scores from the orgasm domain (question #11, #12, #13) and multiplying the sum by the domain factor of 0.4. The domain score for orgasm ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
2647170|NCT01697345|Primary|FSFI Lubrication Domain|The lubrication score is calculated by adding the individual scores from the lubrication domain (question #7, #8, #9, #10) and multiplying the sum by the domain factor of 0.3. The domain score for lubrication ranges from 0 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
2647171|NCT01697345|Primary|FSFI Arousal Domain|The arousal score is calculated by adding the individual scores from the arousal domain (question #3, #4, #5, #6) and multiplying the sum by the domain factor of 0.3. The arousal domain score ranges from 0 (minimum) to 6 (maximum)and a higher value represents a better outcome.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
2647172|NCT01697345|Primary|FSFI Desire Domain|The desire score is calculated by adding the individual scores from the desire domain (question #1 and #2) and multiplying the sum by the domain factor of 0.6. The domain score for desire ranges from 1.2 (minimum) to 6 (maximum) and a higher value represents a better outcome.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
2647422|NCT01694641|Secondary|Live Birth|live birth after 24 weeks gestation|delivery after 24 weeks|All patients randomzed regardless whether completed the study or not according to their assignment (intention to treat population).|||Participants|||Count of Participants
2647173|NCT01697345|Primary|Total Female Sexual Function Index (FSFI) Score|The Female Sexual Function Index (FSFI) questionnaire was administered to participants prior to starting vaginal testosterone therapy and the survey was repeated after using the study drug for 4 weeks. The participants served as their own controls. The FSFI assesses six domains of sexual functioning (desire, arousal, lubrication, orgasm, satisfaction, and pain) over the past 4 weeks. The sum of all domain scores equals the total FSFI score. The total FSFI score ranges from 2-36 and a total FSFI score < 26.5 suggests female sexual dysfunction.|Baseline, 4 weeks||||units on a scale||Standard Deviation|Mean
2647174|NCT01697332|Primary|Spatial Heterogeneity|Determine the degree to which the spatial heterogeneity of regional 129Xe measurements of pulmonary function in a single individual correlates with physical manifestations of disease severity. We hypothesize that measures of spatial heterogeneity will correlate highly with physical disability.|4 years|No data analyzed or collected for this outcome measure.||||||
2647175|NCT01697332|Primary|Differences Between Healthy and Diseased COPD Subjects.|Hyperpolarized 129Xe MRI measures of disease severity in GOLD Stage 1-3 subjects are more highly correlated with physical disabilities associated with their pulmonary disease than traditional tests of pulmonary function.|4 years|No data analyzed or collected for this outcome measure.||||||
2647176|NCT01697332|Primary|Baseline Statistics of Healthy Subjects|Hyperpolarized 129Xe MRI scans will be performed on healthy subjects and the uptake of 129Xe in the pulmonary septal tissue will be measured as a function of time. From this data, the mean and distribution of three pulmonary functional parameters will be determined. The three measures are alveolar surface area per unit volume, septal thickness and capillary transit time through the gas exchange region.|4 years|No data collected or analyzed for this outcome measure.||||||
2647177|NCT01697319|Primary|Percent Change From Baseline in Speed as Measured in Timed 25-Foot Walk Test (25FWT)|The timed 25-Foot Walk Test (25FWT) is an assessment of mobility and performance of leg function. The patient was instructed to walk a marked 25-foot course as quickly as possible in a time limit of 3 minutes and immediately walk back the same distance when reaching one end.The patient is allowed to use any ambulation method to move. The outcome measures the speed (feet / min) of moving.|Up to 96 weeks|Modified ITT Population|||% of change||Standard Deviation|Mean
2647178|NCT01697319|Primary|Change From Baseline in Strength as Assessed by Grip and Pinch Test (GPT)|A grip-strength dynamometer and a pinch meter were used to measure grip strength and pinch strength. The results report change from baseline in strength for dominant and non-dominant hand in a forearm and wrist supported position.|Up to 96 weeks|Modified ITT Population|||kg||Standard Deviation|Mean
2647179|NCT01697319|Secondary|Percent Change From Baseline in Normalized Urine Keratan Sulfate (uKS)|Urinary keratan sulfate and urinary creatinine were measured through quantitative analysis. uKS is normalized to creatinine.|Up to 96 weeks|Modified ITT Population|||% of change||Standard Deviation|Mean
2647180|NCT01697319|Primary|Percent Change From Baseline in Speed as Measured in Functional Dexterity Test (FDT)|FDT assesses the ability to use the hand in daily tasks. The test involves turning 16 wooden pegs over as quickly as possible on a hardwood pegboard with one hand requiring a three-jaw chuck prehension pattern between the fingers and thumb within a two-minute time limit. Hand function is evaluated by how fast a patient can turn over pegs in the given time limit, i.e. speed (number of pegs/minute).|Up to 96 weeks|Modified ITT Population|||% of change||Standard Deviation|Mean
2647181|NCT01696994|Secondary|T5 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T5 (five years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T5 were analyzed.|||Participants|||Number
2647182|NCT01696994|Secondary|T4 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T4 (four years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T4 were analyzed.|||Participants|||Number
2647183|NCT01696994|Primary|Ovarian Cancer Death Rates (Including Primary Peritoneal and Fallopian Tube Cancers)|Ovarian cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.|||Deaths per 10,000 PY|||Number
2647184|NCT01696994|Secondary|T3 TVU Screening Results|Transvaginal Ultrasound (TVU) result.|T3 (three years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T3 were analyzed.|||Participants|||Number
2647185|NCT01696994|Secondary|T3 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T3 (three years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T3 were analyzed.|||Participants|||Number
2647186|NCT01696994|Secondary|T2 TVU Screening Results|Transvaginal Ultrasound (TVU) result.|T2 (one year after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T2 were analyzed.|||Participants|||Number
2647187|NCT01696994|Secondary|T2 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T2 (two years after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T2 were analyzed.|||Participants|||Number
2647188|NCT01696994|Secondary|T1 TVU Screening Results|Transvaginal Ultrasound (TVU) result.|T1 (one year after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T1 were analyzed.|||Participants|||Number
2647189|NCT01696994|Secondary|T1 CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T1 (one year after entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T1 were analyzed.|||Participants|||Number
2647190|NCT01696994|Secondary|T0 (Baseline) TVU Screening Results|Transvaginal Ultrasound (TVU) result.|T0 (at study entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a TVU screen at T0 were analyzed.|||Participants|||Number
2647191|NCT01696994|Secondary|T0 (Baseline) CA-125 Screening Results|Cancer Antigen 125 (CA-125) result.|T0 (at study entry)|Females in the Ovarian Screening arm (excluding females with no ovaries at baseline) who had a CA-125 screen at T0 were analyzed.|||Participants|||Number
2671403|NCT01476267|Secondary|Correlation of Metabolic Profile With Enzyme/Transporter Genotypes||approximately 3 months|Data was not collected||||||
2647193|NCT01696994|Secondary|Ovarian Cancer Incidence Rates (Including Primary Peritoneal and Fallopian Tube Cancers).|Ovarian cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as ovarian cancer diagnoses divided by person years at risk for ovarian cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.|||Diagnoses per 10,000 PY|||Number
2647194|NCT01696994|Secondary|Ovarian Cancer Incidence (Including Primary Peritoneal and Fallopian Tube Cancers)|Ovarian cancer diagnoses confirmed by medical record abstraction.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
2647195|NCT01696994|Secondary|Death Rates From All Causes|Deaths from all causes were compared between the ovarian cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|Female participants, excluding females without ovaries at baseline, were analyzed. An intention-to-treat analysis was performed.|||Deaths per 10,000 PY|||Number
2647196|NCT01696994|Secondary|Deaths From All Causes|Deaths from all causes were compared between the ovarian cancer screening arm and the usual care arm.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.||||Participants|||Number
2647197|NCT01696994|Primary|Ovarian Cancer Deaths (Including Primary Peritoneal and Fallopian Tube Cancers)|Ovarian cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.||||Participants|||Number
2647198|NCT01696981|Secondary|T3/T5 FSG Screening Result|Flexible sigmoidoscopy (FSG) result|T3 (three years after entry) or T5 (five years after entry)|All participants in the Colorectal Screening arm who had an FSG at T0 or T3 were analyzed.|||Participants|||Number
2647199|NCT01696981|Secondary|T0 (Baseline) FSG Screening Results|Flexible sigmoidoscopy (FSG) result|T0 (at study entry)|All participants in the Colorectal Screening arm who had an FSG at T0 were analyzed.|||Participants|||Number
2647200|NCT01696981|Primary|Colorectal Cancer Death Rates|Colorectal cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.||||Deaths per 10,000 PY|||Number
2647201|NCT01696981|Secondary|Complications of Diagnostic Evaluation Following a Positive Screening Test|Number of participants who experienced complications during diagnostic work-up of a positive colorectal examination.|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 2 positive screens with documented follow-up after each one, he would be counted 2 times in the number of units analyzed.|||Positive screens w/ complications|Positive Screens with Follow-up||Number
2647202|NCT01696981|Secondary|Colorectal Cancer Incidence Rates|Colorectal cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as colorectal cancer diagnoses divided by person years at risk for colorectal cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|All participants. An intention-to-treat analysis was performed.|||Diagnoses per 10,000 PY|||Number
2647203|NCT01696981|Secondary|Colorectal Cancer Incidence|Colorectal cancer diagnoses confirmed by medical record abstraction.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|All participants. An intention-to-treat analysis was performed.|||Participants|||Number
2647204|NCT01696981|Secondary|Death Rates From All Causes|Deaths from all causes were compared between the colorectal cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|All participants. An intention-to-treat analysis was performed.|||Deaths per 10,000 PY|||Number
2647205|NCT01696981|Secondary|Deaths From All Causes|Deaths from all causes were compared between the colorectal cancer screening arm and the usual care arm.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.|All participants. An intention-to-treat analysis was performed.|||Participants|||Number
2647206|NCT01696981|Primary|Colorectal Cancer Deaths|Colorectal cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.1 years.||||Participants|||Number
2647207|NCT01696968|Secondary|T3 CXR Screening Results|Postero-anterior view chest radiograph (CXR) result|T3 (three years after entry)|All participants in the Lung Screening arm who had a CXR screen at T3 were analyzed.|||Participants|||Number
2647208|NCT01696968|Secondary|T2 CXR Screening Results|Postero-anterior view chest radiograph (CXR) result|T2 (two years after entry)|All participants in the Lung Screening arm who had a CXR screen at T2 were analyzed.|||Participants|||Number
2647209|NCT01696968|Primary|Lung Cancer Death Rates|Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.||||Deaths per 10,000 PY|||Number
2647210|NCT01696968|Secondary|T1 CXR Screening Results|Postero-anterior view chest radiograph (CXR) result|T1 (one year after entry)|All participants in the Lung Screening arm who had a CXR screen at T1 were analyzed.|||Participants|||Number
2647211|NCT01696968|Secondary|T0 (Baseline) CXR Screening Results|Postero-anterior view chest radiograph (CXR) result|T0 (at study entry)|All participants in the Lung Screening arm who had a CXR screen at T0 were analyzed.|||Participants|||Number
2647212|NCT01696968|Secondary|Complications of Diagnostic Evaluation Following a Positive Screening Test|Number of positive screens with complications.|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 3 positive screens with documented follow-up after each one, he would be counted 3 times in the number of units analyzed.|||Positive screens w/ complications|Positive Screens with Follow-up||Number
2647213|NCT01696968|Secondary|Lung Cancer Incidence Rates|Lung cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as lung cancer diagnoses divided by person years at risk for lung cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.|||Diagnoses per 10,000 PY|||Number
2647214|NCT01696968|Secondary|Lung Cancer Incidence|Lung cancer diagnoses confirmed by medical record abstraction.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
2647215|NCT01696968|Secondary|Death Rates From All Causes|Deaths from all causes were compared between the lung screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.|||Deaths per 10,000 PY|||Number
2647216|NCT01696968|Secondary|Deaths From All Causes|Deaths from all causes were compared between the lung screening arm and the usual care arm.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
2647217|NCT01696968|Primary|Lung Cancer Deaths|Lung cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 11.9 years.|All participants were analyzed. An intention-to-treat analysis was performed.|||Participants|||Number
2647218|NCT01696955|Other Pre-specified|Number of Patients With Serious Adverse Events While on Single-agent Tivantinib After Failure of Cetuximab|CTCAE (4.0)|3 years|This outcome pertains only to Tivantinib after Cetuximab Failure and therefore Arm 1 contains 0 analyzed.|||Participants|||Count of Participants
2647219|NCT01696955|Other Pre-specified|Number of Participants With Adverse Events While on Single-agent Tivantinib After Failure of Cetuximab|Non-serious adverse events, CTCAE (4.0)|Up to 3 years|This outcome pertains only to Tivantinib after Cetuximab Failure and therefore Arm 1 contains 0 analyzed.|||Participants|||Count of Participants
2647220|NCT01696955|Secondary|Overall Response Rate of Single-agent Tivantinib After Failure of Cetuximab|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 1 year|This outcome pertains only to Tivantinib after Cetuximab failure and therefore Arm 1 contains 0 analyzed.|||Participants|||Count of Participants
2647221|NCT01696955|Secondary|Progression-free Survival|Time from randomization until disease progression/death from any cause or date last know progression-free|Up to 3 years||||months||95% Confidence Interval|Median
2647222|NCT01696955|Secondary|Overall Survival|Time from randomization until death or date last known alive|Up to 5 years||||months||95% Confidence Interval|Median
2647223|NCT01696955|Secondary|Change in Tumor Burden|Early change in tumor burden measured using the sum of longest diameters of target lesions, expressed as percent change from baseline.|Baseline to 8 weeks|Patients with baseline and 8 week measurements available|||percent change||Standard Deviation|Mean
2647224|NCT01696955|Secondary|c-MET Expression|Change in c-MET expression from baseline to 8 weeks|Baseline to 8 weeks|Assay not performed.||||||
2647225|NCT01696955|Secondary|c-MET Copy Number|Change in copy number from baseline to 8 weeks|Baseline to 8 weeks|Assay not performed.||||||
2647226|NCT01696955|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 1 year||||Participants|||Count of Participants
2647227|NCT01696942|Secondary|Number of Participants With Endoscopic Recurrence of Crohn's Disease|To compare the endoscopic recurrence rates at one year following surgery between patients treated with certolizumab and mesalamine.|One year following enrollment|Subjects available for colonoscopy at 12 month visit. This visit was sometimes separated from the overall 12-month visit so only 1 (cimzia) and 2 (mesalamine) patients respectively had the colonoscopy performed.|||Participants|||Count of Participants
2647228|NCT01696942|Primary|Clinical Recurrence Rates of Crohn's Disease|To evaluate the difference in clinical recurrence rates between certolizumab and mesalamine after 4 weeks, 3 months, 6 months, 9 months, and 12 months of use following ileocolectomy for Crohn's disease using the Crohn's Disease Activity Index (CDAI). CDAI scores of 150 or greater are considered a recurrence.|4 weeks, 3 months, 6 months, 9 months, and 12 months|Subjects who received CDAI questionnaire. Number of participants fluctuates due to withdrawals and missed appointments.|||Participants|||Count of Participants
2647229|NCT01696929|Secondary|Change in Total Psychotic Symptoms|The Positive and Negative Symptoms Scale (PANSS) is the metric used to characterize psychotic symptoms in this study. The PANSS consists of 30 items, each scored 1-7. The range for the PANSS total score is 30-210. There are 3 subscales - PANSS positive score (range 7-49), PANSS negative score (range 7-49), and PANSS general score (range 16-112). PANSS total score is the summation of these 3 subscales. Higher values for the total and subscale scores reflect more severe psychopathology. A positive change in PANSS total score reflects an increase in psychopathology. A negative change in PANSS total score reflects a decrease in psychopathology.|Change in PANSS total score from baseline to 8 weeks||||Change in PANSS Total Score||Standard Deviation|Mean
2647271|NCT01696279|Secondary|Change From Baseline in Biochemical Bone Markers for Fetuin-A|Change from baseline in bone turnover markers for fetuin-A was reported for combined Part 2 and 3. End of the study is the completion if the participants has benefited from and desires to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.|Baseline, Week 8, Week 16 and EOS (up to 42 weeks)|PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.|||gram per liter (g/L)||Standard Error|Mean
2647230|NCT01696929|Primary|Change in Cognition|The Brief Assessment of Cognition in Schizophrenia (BACS) is the metric used to characterize cognition in this study. The BACS consists of 6 subscales: Verbal Memory (range 0-75), Working Memory (range 0-28), Motor Speed (range 0-100), Verbal Fluency (measure is total number of words generated in two 60 second trials), Attention and Processing speed (range 0-110), and Executive Function (range 0-22). For each subscale, higher scores reflect better cognition. For each subscale, a Standard Deviation Score was calculated based on normative data (Keefe et al. Norms and standardization of the Brief Assessment of Cognition in Schizophrenia (BACS). Schizophrenia Research 102 (2008) 108-115). The BACS composite score is calculated as the average Standard Deviation Score of the 6 subscale scores. The change in BACS composite score was calculated as the BACS composite score at 8 weeks minus the BACS composite score at baseline.|Change in BACS composite score from baseline to 8 weeks||||Change in BACS Composite Score||Standard Deviation|Mean
2647231|NCT01696877|Secondary|Percentage of Participants Without Prostate Specific Antigen Recurrence at 24 Months After Surgery|Percentage of participants in each arm who were free of prostate specific antigen recurrence (i.e. prostate specific antigen remained undetectable after prostatectomy) at 24 months after undergoing surgery.|2 years||||percentage of participants||95% Confidence Interval|Number
2647232|NCT01696877|Secondary|Prostate-specific Antigen Response Rate|Number of participants with Prostate-specific antigen response|2 years||||Participants|||Count of Participants
2647233|NCT01696877|Secondary|Serum Antibodies to Prostate-associated Antigens|Number of participants with generation of novel antibodies to prostate-associated antigens in the serum of patients, after the initiation of protocol therapy|2 years|Data was not collected for this outcome measure||||||
2647234|NCT01696877|Secondary|Pathological Complete Responses|Number of participants with pathological complete response (pCR)|2 years||||Participants|||Count of Participants
2647235|NCT01696877|Secondary|Quantification of Markers of Apoptosis|Amount of apoptosis (activated caspase 3) and proliferation (Ki-67) in prostate tumor specimens|2 years|Data was not collected for this outcome measure||||||
2647236|NCT01696877|Secondary|Quantification of Tissue Androgen Concentrations|Tissue androgen concentrations (testosterone, dihydrotestosterone), and androgen receptor (AR) protein expression in prostate specimens|2 years|Data was not collected for this outcome measure||||||
2647237|NCT01696877|Secondary|Intraprostatic CD4+ T Cell and Treg Infiltration|Number of participants with CD4+ T cell and Treg infiltration into the prostate.|2 years|Data was not collected for this outcome measure||||||
2647238|NCT01696877|Primary|Intraprostatic CD8+ T Cell Infiltration|CD8+ T cell infiltration (quantified as log[CD8 density]) into the prostate from harvested prostate glands in men with localized prostate cancer receiving neoadjuvant Androgen deprivation therapy alone (2 weeks prior to surgery), or cyclophosphamide and GVAX followed by Androgen deprivation therapy, (with cyclophosphamide/GVAX administered 4 weeks prior to prostatectomy, and Androgen deprivation therapy administered 2 weeks prior to prostatectomy).|2 years||||log10 (cells/mm^2)||95% Confidence Interval|Mean
2647239|NCT01696773|Primary|Pharmacokinetics of Carotenoid Absorption|The primary goal of this research is to determine if a processed tangerine tomato product has enhanced bioavailability of carotenoids and flavonoids compared to a commercially available processed red tomato product in humans. An area under the curve for concentration of carotenoids (from triglyceride rich lipoprotein (TRL) fraction of plasma) by using carotenoid concentrations from hours 0, 2, 3, 4, 5, 6, 8, 10 and 12 over time to quantify absorption, after subjects consume a meal containing tangerine or red tomato juice.|11 post-prandial blood samples will be taken over 12 hours||||nmol*h/L||Standard Error|Mean
2647240|NCT01696760|Secondary|Death Rate||Up to 3 months||||Participants|||Count of Participants
2647241|NCT01696760|Secondary|Excessive Wound Drainage||Up to 3 months||||Participants|||Count of Participants
2647242|NCT01696760|Secondary|Hematoma Formation||Up to 3 months||||Participants|||Count of Participants
2647243|NCT01696760|Secondary|Readmission Rate to Hopsital||Up to 3 months||||Participants|||Count of Participants
2647244|NCT01696760|Secondary|Development of Other Complications (Including Bleeding Complications)||Up to 3 months||||Participants|||Count of Participants
2647245|NCT01696760|Secondary|Pulmonary Embolism Rate||Up to 3 months||||Participants|||Count of Participants
2647246|NCT01696760|Primary|DVT Incident Rate|This study will test if the ASA+PCD treatment group has a DVT rate (P1) not more than the DVT rate of the LMWH+PCD treatment group (P0) using a one sided test for these two proportions. Statistical significance will be defined as p < 0.05.|Up to 3 months||||Participants|||Count of Participants
2647247|NCT01696695|Secondary|Percentage of Participants With Dose Modification of Capecitabine||Baseline up to 1254 days|ITT Population.|||Percentage of participants|||Number
2647248|NCT01696695|Secondary|Mean Duration of Capecitabine Therapy||Baseline up to 1254 days|ITT Population. Here, N (number of participants analyzed) indicates the total number of participants who provided evaluable data for this outcome measure.|||Days||Standard Deviation|Mean
2647249|NCT01696695|Secondary|Percentage of Participants Who Underwent Metastasectomy|Metastasectomy is the surgical removal of metastases, which are secondary cancerous growths that have spread from cancer originating in another organ in the body.|Baseline up to 1254 days|ITT Population. Here, N (number of participants analyzed) indicates the total number of participants who provided evaluable data for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2647272|NCT01696279|Secondary|Change From Baseline in Biochemical Bone Markers for Parathyroid Hormone (PTH)|Change from baseline in bone turnover markers for parathyroid hormone was reported for combined Part 2 and 3. End of the study is the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.|Baseline, Week 8, Week 16 and EOS (up to 42 weeks)|PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.|||picomole per litre (pmol/L)||Standard Error|Mean
2647250|NCT01696695|Secondary|Percentage of Participants With Clinical Benefit as Assessed Using RECIST v1.1|Clinical benefit was defined as having a confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST v1.1.CR: complete disappearance of all target lesions and non-target disease,with the exception of nodal disease.All nodes,both target and non-target, must decrease to normal (short axis <10 mm).No new lesions.PR: >=30% decrease under baseline of the sum of diameters of all target lesions.The short axis was used in the sum for target nodes,while the longest diameter was used in the sum for all other target lesions.No unequivocal progression of non-target disease.No new lesions.SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum diameters while on study.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions,or presence of new lesions.|Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254|ITT Population.|||Percentage of participants||95% Confidence Interval|Number
2647251|NCT01696695|Secondary|Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1|Overall response is defined as a complete response (CR) or a partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. Participants were evaluated for tumor response per RECIST v1.1 and assessed by computed tomography (CT) or magnetic resonance imaging (MRI):CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 mm). No new lesions.PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254|ITT population.|||Percentage of participants||95% Confidence Interval|Number
2647252|NCT01696695|Primary|PFS by Therapeutic Regimens|PFS was assessed using RECIST v1.1 and is defined as the time from the first dose of indicated treatment to PD or death, whichever occurred first. Participants who did not progress or died while being followed were censored on the date of the last visit. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm; progression of existing non-target lesions; or presence of new lesions. Median PFS was estimated using Kaplan-Meier method.|Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254|ITT Population. Here, number (n)= number of participants evaluable for the specified therapeutic regimen.|||Days||95% Confidence Interval|Median
2647253|NCT01696695|Primary|Median Progression-free Survival (PFS)|PFS was assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and is defined as the time from the first dose of indicated treatment to disease progression (PD) or death, whichever occurred first. Participants who did not progress or died while being followed were censored on the date of the last visit. Participants without post-baseline tumor assessments were conservatively censored on the date of first study medication, which is PFS was assigned a value of 1 day. PD: at least 20 percent (%) increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm); progression of existing non-target lesions; or presence of new lesions. Median PFS was estimated using Kaplan-Meier method.|Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254|ITT Population|||Days||95% Confidence Interval|Median
2647254|NCT01696643|Other Pre-specified|Number of Participants With Adjudicated Cardiovascular, Gastrointestinal, or Central Opioid Withdrawal Events|"Cardiovascular (CV) events of interested included mycardial infarction, unstable angina, CV accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death.~Gastrointestinal (GI) events of interest included emergency department visits for the serious adverse events of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping.~Central opioid withdrawal (OW) events of interest included opioid withdrawal syndrome. The adverse events that indicated central OW included, but were not limited to, hyperhidrosis, tremor, dysphoria, and myalgia.~The number of participants with at least 1 confirmed CV, GI, or Central OW event is presented."|Baseline through Week 56|All randomized participants who received at least 1 dose of study drug. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.|||participants|||Number
2647255|NCT01696643|Secondary|Plasma Trough Concentrations of CB-5945|Blood samples for trough concentrations of CB-5945 were collected before the participant's morning dose of study drug at Weeks 4, 12, 24, 36, and 52. Overall concentration was based on the mean trough level for each participant across all weeks.|Weeks 4, 12, 24, 36, and 52|All participants randomized to CB-5945 who received at least 1 dose of study drug and had evaluable CB-5945 concentration data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.|||picograms per milliliter (pg/mL)||Standard Deviation|Mean
2647256|NCT01696643|Secondary|Change From Baseline in Patient-Reported Constipation Severity Assessment (PCSA) at Week 52|The PCSA asked participants to rate the severity of their overall constipation during the 24 hours prior to the assessment, using a scale of 0 to 10, where 0 is no constipation and 10 is the worst constipation imaginable.|Baseline, Week 52|All randomized participants who received at least 1 dose of study drug and had evaluable PCSA data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.|||units on a scale||Standard Deviation|Mean
2647297|NCT01696084|Secondary|Event-free Survival|All randomized subjects were assessed for event-free survival (EFS). EFS was defined as the time from study randomization to the date of induction treatment failure (persistent disease), relapse from CR or CRi or death from any cause, whichever came first. Subjects alive and not known to have any of these events were censored on thee date they were last examined on study.|From the date of randomization to the date that persistent disease was documented or the date of relapse after CR or death, whichever came first|Intent-to-Treat (ITT) Population: All participants randomized in the study.|||months||95% Confidence Interval|Median
2647257|NCT01696643|Secondary|Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire at Week 52|The PAC-QOL questionnaire contains a total of 28 items, each rated within 4 subscales: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. Each item was rated on a 5-point Likert scale with the following score definitions, depending on the question: 0 = not at all (or none of the time), 1 = a little bit (or a little of the time), 2 = moderately (or some of the time), 3 = quite a bit (or most of the time), and 4 = extremely (or all of the time). The total score is the mean of all non-missing items. The range of the total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). Negative change from baseline values indicate improvement in constipation quality of life. Each participant completed the PAC-QOL at Baseline and Week 52 using a 2-week recall period.|Baseline, Week 52|All randomized participants who received at least 1 dose of study drug and had evaluable PAC-QOL data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.|||units on a scale||Standard Deviation|Mean
2647258|NCT01696643|Secondary|Change From Baseline in Mean Daily Opioid Dose at Weeks 49-52|Throughout the study, participants were asked to record changes in maintenance opioid consumption and use of opioid analgesics for breakthrough or exacerbation of pain in a paper diary. Opioid consumption (including rescue opioids) of each participant was converted to an oral morphine-equivalent total daily dose (METDD). Opioid consumption (in milligrams of METDD) was summarized in 4-week intervals. The change from baseline to Weeks 49-52 is summarized.|Baseline, Weeks 49-52|All randomized participants who received at least 1 dose of study drug and had evaluable METDD data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.|||milligrams of METDD||Standard Deviation|Mean
2647259|NCT01696643|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|"A TEAE was defined as any adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing AEs that were aggravated in severity or frequency during the dosing period. The percentages of participants with at least 1 TEAE, with at least 1 drug-related TEAE (drug-related included possibly related or related as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE are presented. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module."|Baseline through Week 56|All randomized participants who received at least 1 dose of study drug. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis.|||percentage of participants|||Number
2647260|NCT01696396|Secondary|Change From Baseline in CDAI Score at Week 8|The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.|Baseline and week 8|The full analysis set includes all randomized participants who received at least 1 dose of study drug. Missing data were handled using the inverse probability weighting (IPW) method.|||units on a scale||Standard Error|Least Squares Mean
2647261|NCT01696396|Secondary|Change From Baseline in CDAI Score at Week 12|The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.|Baseline and week 12|The full analysis set includes all randomized participants who received at least 1 dose of study drug. Missing data were handled using the inverse probability weighting (IPW) method.|||units on a scale||Standard Error|Least Squares Mean
2647262|NCT01696396|Secondary|Percentage of Participants With Sustained Remission at Both Week 8 and Week 24|"Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150. Sustained remission was defined as achieving the criteria for remission at both week 8 and week 24.~The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.~The remission rate (percentage of participants with sustained remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate)."|Week 8 and week 24|The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted sustained remission rates were calculated using non-responder imputation, where participants with missing CDAI scores at week 8 or week 24 were counted as non-responders.|||percentage of participants|||Number
2647263|NCT01696396|Secondary|Percentage of Participants With Sustained Remission at Both Week 12 and Week 24|"Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150. Sustained remission was defined as achieving the criteria for remission at both week 12 and week 24.~The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.~The remission rate (percentage of participants with sustained remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate)."|Week 12 and week 24|The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted sustained remission rates were calculated using non-responder imputation, where participants with missing CDAI scores at week 12 or week 24 were counted as non-responders.|||percentage of participants|||Number
2647264|NCT01696396|Secondary|Percentage of Participants With Response at Week 8|"Response was defined as either remission (a CDAI score < 150) or a decrease from baseline in the CDAI score of ≥ 100 points.~The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.~The response rate (percentage of participants with response) was calculated based on observed data (unadjusted response rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI score (adjusted response rate)."|Baseline and week 8|The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted response rates were calculated using non-responder imputation, where participants with a missing CDAI Score at week 8 were counted as non-responders.|||percentage of participants|||Number
2647265|NCT01696396|Secondary|Percentage of Participants With Response at Week 12|"Response was defined as either remission (a CDAI score < 150) or a decrease from baseline in the CDAI score of ≥ 100 points.~The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.~The response rate (percentage of participants with response) was calculated based on observed data (unadjusted response rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI score (adjusted response rate)."|Baseline and week 12|The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted response rates were calculated using non-responder imputation, where participants with a missing CDAI Score at week 12 were counted as non-responders.|||percentage of participants|||Number
2647266|NCT01696396|Secondary|Percentage of Participants With Remission at Week 12|"Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.~The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate)."|Week 12|The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted remission rates were calculated using non-responder imputation, where participants with a missing CDAI Score at week 12 were counted as non-responders.|||percentage of participants|||Number
2647267|NCT01696396|Primary|Percentage of Participants With Remission at Week 8|"Remission was defined as a Crohn's Disease Activity Index (CDAI) score < 150 at week 8.~The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.~The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline CDAI Score (adjusted remission rate)."|Week 8|The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted remission rates were calculated using non-responder imputation, where participants with a missing CDAI Score at week 8 were counted as non-responders.|||percentage of participants|||Number
2647268|NCT01696357|Primary|Average Number of Coughs Per Hour|The device is supposed to detect and count the number of coughs per 24 hours and register the numbers into the device.|7 days|One subject in the non-asthma group failed to return the device after the 7-trial. Data from 22 participants (3 from the asthma group, 19 from non-asthma group) were not included in the analysis as no data were recorded (due to a mechanical issue) or data were too extreme (due to cough algorithm failure).|||average number of coughs per hour||Standard Deviation|Mean
2647269|NCT01696279|Secondary|Change From Baseline in Weight|Change from baseline in weight for combined Part 2 and Part 3 for each drug at Week 8, 16 and end of study was reported. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.|Baseline, Week 8, Week 16, and EOS (up to 42 weeks)|PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.|||kilogram (Kg)||Standard Error|Mean
2647270|NCT01696279|Secondary|Change From Baseline in Height|Change from baseline in height for combined Part 2 and Part 3 for each drug at Week 8, 16 and end of study was reported. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.|Baseline, Week 8, Week 16, and EOS (up to 42 weeks)|PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.|||centimeter (cm)||Standard Error|Mean
2647273|NCT01696279|Secondary|Change From Baseline in Biochemical Bone Markers for Fibroblast Growth Factor 23 (FGF-23)|Change from baseline in bone turnover markers including fibroblast growth factor 23 (FGF-23) was reported for combined Part 2 and 3. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.|Baseline, Week 8, Week 16 and EOS (up to 42 weeks)|PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.|||relative unit per milliliter (RU/ml)||Standard Error|Mean
2647274|NCT01696279|Secondary|Change From Baseline in Biochemical Bone Markers for Tartrate-Resistant Acid Phosphatase (TRAP)|Change from baseline in bone turnover markers for, tartrate-resistant acid phosphatase (TRAP) was reported for combined Part 2 and 3. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.|Baseline, Week 8, Week 16 and EOS (up to 42 weeks)|PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.|||unit per liter (U/L)||Standard Error|Mean
2647275|NCT01696279|Secondary|Change From Baseline in Biochemical Bone Markers|Change from baseline in bone turnover markers including bone alkaline phosphatase (ALP), osteocalcin, and sclerostin was reported for combined Part 2 and 3. End of the study (EOS) was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.|Baseline, Week 8, Week 16 and EOS (up to 42 weeks)|PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.|||microgram per liter (ug/L)||Standard Error|Mean
2647276|NCT01696279|Secondary|Change From Baseline in Calcium-Phosphorus Product Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3|Change from baseline in calcium-phosphorus product levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6-month extension phase (Part 3) were reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. The unit of measure of this outcome was millimole square per square liter. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.|Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32|PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.|||mmol^2/L^2||Standard Error|Mean
2647277|NCT01696279|Secondary|Change From Baseline in Calcium Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3|Change from baseline in calcium levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6- month extension phase (Part 3) were reported.Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.|Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32|PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.|||millimole per liter (mmol/L)||Standard Error|Mean
2647278|NCT01696279|Secondary|Change From Baseline in Serum Phosphorus Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3|Change from baseline in serum phosphorus levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6-month extension phase (Part 3) were reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.|Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32|PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.|||millimole per liter (mmol/L)||Standard Deviation|Mean
2647298|NCT01696084|Secondary|Proportion of Subjects With a Response|Complete Remission (CR)|Post Induction|Intent-to-Treat (ITT) Population: All participants randomized in the study.|||Participants|||Count of Participants
2647299|NCT01696084|Primary|Overall Survival|Overall survival was measured from the date of randomization to death from any cause, subjects not known to have died by the last follow-up were censored on the date they were last known to be alive.|From the date of randomization to death from any cause|Intent-to-Treat (ITT) Population: All participants randomized in the study.|||months||95% Confidence Interval|Median
2647423|NCT01694641|Primary|Pregnancy Rate|rise in beta HCG 12-14 days after transfer|12-14 days after transfer|All patients randomized are analyszs (intention to treat analysis).|||Participants|||Count of Participants
2647279|NCT01696279|Secondary|Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2|Changes from baseline in calcium-phosphorus product levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. The unit of measure for this outcome was millimole square per square liter. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.|Baseline, Week 8|PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.|||mmol^2/L^2||Standard Error|Mean
2647280|NCT01696279|Secondary|Change From Baseline in Calcium Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2|Changes from baseline in calcium levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.|Baseline, Week 8|PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.|||millimole per liter (mmol/L)||Standard Error|Mean
2647281|NCT01696279|Secondary|Change From Baseline in Serum Phosphorus Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2|Changes from baseline in serum phosphorus levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.|Baseline, Week 8|PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.|||millimole per liter (mmol/L)||Standard Error|Mean
2647282|NCT01696279|Secondary|Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Lanthanum Carbonate After Week 8|Changes from baseline in calcium-phosphorus product levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. The unit of measure for this outcome measure was millimole square per square liter (mmol^2/L^2). Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.|Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3|PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.|||mmol^2/L^2||Standard Error|Mean
2647283|NCT01696279|Secondary|Change From Baseline in Calcium Levels Following Treatment With Lanthanum Carbonate After Week 8|Changes from baseline in calcium levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.|Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3|PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.|||millimole per liter (mmol/L)||Standard Error|Mean
2647284|NCT01696279|Secondary|Change From Baseline in Serum Phosphorus Levels Following Treatment With Lanthanum Carbonate After 8 Weeks|Changes from baseline in serum phosphorus levels in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.|Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3|PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.|||millimoles per liter (mmol/L)||Standard Error|Mean
2647308|NCT01696071|Secondary|FEV1 AUC12-24h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC12 -24h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|Baseline FEV1 taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres||Standard Error|Least Squares Mean
2647285|NCT01696279|Secondary|Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level During Part 2|KDOQI serum phosphorus targets was defined for: Adolescents aged >= 12 < 18 years to be <= 5.5 mg/dL (1.78 [mmol/L]); Children aged >=10 years to <12 years to be <= 6.0 mg/dL (1.94 mmol/L). Percentage of participants achieving age-specific KDOQI targets for serum phosphate level were reported only for the participants who had received calcium carbonate followed by 8 weeks of treatment with lanthanum carbonate in Part 2. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.|Up to 19 weeks|Per Protocol Set 1 (PP1) included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.|||Percentage of participants|||Number
2647286|NCT01696279|Primary|Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level Following 8 Weeks of Lanthanum Carbonate Administration (Part 2 + Part 3)|KDOQI serum phosphorus targets were defined for: Adolescents aged greater than or equal to (>=) 12 to less than (<) 18 years to be less than or equal to (<=) 5.5 milligrams per deciliter (mg/dL) (1.78 millimoles per liter [mmol/L]); Children aged >=10 years to <12 years to be <= 6.0 mg/dL (1.94 mmol/L). Percentage of participants achieving age-specific KDOQI targets for serum phosphate level was reported only for the participants who had received lanthanum carbonate during part 2 or part 3. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.|After 8 weeks of lanthanum carbonate administration in Part 2 and/or in Part 3|Per-protocol set 2 (PP2) included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.|||Percentage of participants|||Number
2647287|NCT01696214|Secondary|Percent (%) Perdicted FEV1 Changes|Physiologic measures of % predicted FEV1|Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks. Median scores over the 24 weeks of treatment were compared||||percent predicted FEV1||Standard Deviation|Median
2647288|NCT01696214|Secondary|The Asthma Symptom Utility Index (ASUI)|The Asthma Symptom Utility Index (ASUI), an important secondary outcome in the proposed full-scale TOM Trial, has also been shown to be useful in tracking the frequency and severity of asthma-related symptoms in non-smoking asthmatics. ASUI is a brief, interviewer-administered, patient preference-based scale assessing frequency and severity of selected asthma-related symptoms and treatment side effects. 11 items are reviewed, with 2-week recall to assess four symptoms (cough, wheeze, shortness of breath, and awakening at night) and medication side-effects each on two dimensions (frequency and severity). 4-point Likert scale is used to assess frequency (not at all, 1 to 3 days, 4 to 7 days, and 8 to 14 days) and severity (not applicable, mild, moderate and severe). Scores range from 0 (worst possible symptoms) to 1 (no symptoms). The change between two time points, initial visit and after 24 weeks of treatment, is reported. The median value is reported with the standard deviation.|Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and a follow-up visit 1 month off study drug. Median scores, change from initial visit and end of treatment, were compared||||units on a scale||Standard Deviation|Median
2647289|NCT01696214|Primary|Asthma Control Test|The primary symptomatic measure, the Asthma Control Test (ACT), has been shown to be valid for measuring poor asthma control in asthmatic children and non-smoking adults. The ACT is a tool developed by Nathan and collaborators a decade ago for evaluating asthma control. It consists of five questions with five possible answers each. A maximum score of 25 points indicates complete asthma control. A score between 20 and 24 represents partially controlled asthma, while a score 19 or below indicates poorly controlled asthma and a score <16 indicates uncontrolled asthma. The minimally important clinical difference has been determined to be 3.|Outcome measure was assessed at the initial visit, at randomization following a wash-in period of 1 month, monthly for 24 weeks and at follow-up visit 1 month off study drug. Median scores over the 24 weeks of treatment were compared.||||units on a scale||Full Range|Median
2647290|NCT01696188|Secondary|Time for Block Placement|Calculate the time to perform the nerve block procedure.|immediately post-procedure||||seconds||95% Confidence Interval|Mean
2647291|NCT01696188|Secondary|Opioid Consumption|Calculate the total amount of opioid consumed in the first 48 hours after surgery using a standard opioid conversion scale. 1 mg hydrocodone = 0.33 mg IV morphine, 1 mg oxycodone = 0.50 mg morphine IV, 1 mg hydromorphone PO = 1.33 mg morphine IV, 1 mcg fentanyl = 0.1 mg morphine IV, 1 mg hydromorphone IV = 6.67 mg morphine IV|48 hours||||mg IV morphine equivalents||Inter-Quartile Range|Median
2647292|NCT01696188|Secondary|Catheter Dislodgements|Inspect the peripheral nerve catheters at 24 hours postoperatively and assess for being in-place or not.|24 hours||||participants|||Number
2647293|NCT01696188|Primary|Visual Analog Scale Pain Scores|Pain was rated from 0 (no pain) to 10 (worst pain imaginable)|24 hours||||units on a scale||Inter-Quartile Range|Median
2647294|NCT01696084|Secondary|Proportion of Subjects Receiving a Stem Cell Transplant|The number and percentage of subjects transferred for HSCT after induction treatment was recorded.|Post Induction|Intent-to-Treat (ITT) Population: All participants randomized in the study.|||Participants|||Count of Participants
2647295|NCT01696084|Secondary|Rate of Achieving Morphologic Leukemia-free State|All randomized subjects with at least 1 evaluable postrandomization bone marrow assessment performed on or after Day 14 after the last induction were assessed for MLFS.|Day 14|Intent-to-Treat (ITT) Population: All participants randomized in the study.|||Participants|||Count of Participants
2647296|NCT01696084|Secondary|Remission Duration|Only subjects achieving CR or CRi were assessed for remission duration.|From the date of achievement of a remission until the date of relapse or death from any cause|Intent-to-Treat (ITT) Population: All participants randomized in the study.|||months||95% Confidence Interval|Median
2647354|NCT01695304|Primary|Longitudinal Diarrhea Prevalence|The primary outcome measure is the longitudinal prevalence of diarrheal disease.|6 months|Incidence rate per 100 person-weeks of observation|||Incidence rate per 100 person-weeks|||Number
2647433|NCT01694420|Other Pre-specified|Number of Participants With Grade 3 or Grade 4 Adverse Events||48 weeks||||participants|||Number
2647300|NCT01696071|Secondary|Peak Expiratory Flow (PEF) AUC0-24h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres per minute.|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres/min||Standard Error|Least Squares Mean
2647301|NCT01696071|Secondary|Trough FVC Responses|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. Trough FVC was defined as the FVC value just prior to the last evening dose of study medication.|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres||Standard Error|Least Squares Mean
2647302|NCT01696071|Secondary|Peak FVC Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. Peak FVC was defined as the highest FVC reading observed within the 24 hour period following inhalation of the last evening dose of study medication (FVC Peak0-24h).|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres||Standard Error|Least Squares Mean
2647303|NCT01696071|Secondary|FVC AUC12-24h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC12 -24h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres||Standard Error|Least Squares Mean
2647304|NCT01696071|Secondary|FVC AUC0-12h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-12h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres||Standard Error|Least Squares Mean
2647305|NCT01696071|Secondary|Forced Vital Capacity (FVC) AUC0-24h Response|"MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.~The values recorded at 11 hours 50 minutes and at 23 hours 50 minutes post dosing were assigned to 12 and 24 hours, respectively."|Baseline taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres||Standard Error|Least Squares Mean
2647306|NCT01696071|Secondary|Trough FEV1 (L) Response.|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. Trough FEV1 was defined as the FEV1 value just prior to the last evening dose of study medication.|10 minutes (min) prior to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres||Standard Error|Least Squares Mean
2647307|NCT01696071|Secondary|Peak FEV1 Response.|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. Peak FEV1 was defined as the highest FEV1 reading observed within the 24 hour period following inhalation of the last evening dose of study medication (FEV1 Peak0-24h). The values recorded at 11 hours 50 minutes and at 23 hours 50 minutes post dosing were assigned to 12 and 24 hours, respectively.|10 minutes (min) prior to dose to 30 min,1 hour (h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks.|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres||Standard Error|Least Squares Mean
2647355|NCT01695291|Secondary|Striatal Glutamate Level Measured by Magnetic Resonance Spectroscopy (MRS).|The change in striatal glutamate level will be assessed.|Change from Baseline at 12 weeks|Due to the early-termination of some participants, not all completed MRS at Week 12|||Arbitrary Units||Standard Deviation|Mean
2647434|NCT01694420|Secondary|Rate of Virologic Decline in the First 48 Weeks of Treatment Comparing FDC ELV/COBI/FTC/TDF to FDC EFV/FTC/TDF||48 weeks||||days||Full Range|Median
2647309|NCT01696071|Secondary|FEV1 AUC0-12h Response|MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-12h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.|Baseline FEV1 taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes(min) prior to dose to 30min,1hour(h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Litres||Standard Error|Least Squares Mean
2647310|NCT01696071|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 - 24h (AUC 0-24) Response.|"Mixed Model Repeated Measure (MMRM) results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline.Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.~The values recorded at 11 hours 50 minutes and at 23 hours 50 minutes post dosing were assigned to 12 and 24 hours, respectively."|Baseline FEV1 taken at visit 2 prior to the first evening dose of randomised study medication. Then, 10 minutes (min) prior to dose to 30 min,1 hour (h),2h,3h,4h,11h50min,12h30min,13h,14h,15h,16h,18h,20h,22h and 23h,23h50min relative to dose after 4 weeks|Full Analysis Set (FAS): The full analysis set (FAS) includes all patients in the treated set who had baseline data and at least one on-treatment efficacy value after 4 weeks on treatment within a period.|||Liters||Standard Error|Least Squares Mean
2647311|NCT01696058|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)|"Rescue medication usage - Mean weekly rescue usage during nighttime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.~Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)"|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||number of puffs||Standard Error|Least Squares Mean
2647312|NCT01696058|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)|"Rescue medication usage - Mean weekly rescue usage during daytime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.~Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)"|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||number of puffs||Standard Error|Least Squares Mean
2647313|NCT01696058|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)|"Rescue medication usage - mean weekly rescue usage (total daily). The baseline for the rescue use was the mean of the observations during the last week of the baseline period. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol metered dose inhaler (MDI) (100 μg per puff) was provided as rescue medication . Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.~Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (555)"|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||usage (total daily) number of puffs||Standard Error|Least Squares Mean
2647314|NCT01696058|Secondary|Rescue Medication Usage - Percentage of Rescue Free Days|"Rescue medication usage - the percentage of rescue free days. The percentage of rescue free days is defined as: number of rescue free days divided by total exposure, multiplied by 100%. The baseline for the number of rescue-free days was defined as the number of rescue-free days observed during the last week of the baseline period (i.e., the 7 days prior to administration of the first dose of randomized treatment).~Results are from non−MMRM ANCOVA models by week with LOCF up to each week. Fixed effects include treatment and baseline.~Number of patients contributing to models: Tio+Placebo (559), Tio+Olo 5ug (552)"|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||percentage of days||Standard Error|Least Squares Mean
2647315|NCT01696058|Secondary|Trough FVC Response at 12 Weeks; Defined as Change From Baseline|Trough Forced Vital Capacity (FVC) response at 12 weeks- defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||L||Standard Error|Least Squares Mean
2647316|NCT01696058|Secondary|Peak FVC Response at 12 Weeks; Defined as Change From Baseline|Peak FVC response at 12 weeks - defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.|||L||Standard Error|Least Squares Mean
2647317|NCT01696058|Secondary|FVC AUC0-3h Response at 12 Weeks; Defined as Change From Baseline|Forced Vital Capacity (FVC) AUC0-3h response at 12 weeks - defined as change from baseline. AUC was standardized by dividing by time unit.|baseline and 12 Weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.|||L||Standard Error|Least Squares Mean
2647318|NCT01696058|Secondary|Peak FEV1 Response at 12 Weeks - Defined as Change From Baseline|Peak FEV1 (Forced Expiratory Volume in 1 second) response at 12 Weeks - defined as change from baseline. All p-values for these measures are only descriptive.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.|||L||Standard Error|Least Squares Mean
2647394|NCT01695135|Secondary|DB Phase: Overall Survival|Overall survival was defined as the time interval from the date of randomization to the date of death from any cause.|From randomization to the date of death due to any cause (up to approximately 3.8 years)|ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.|||Days||95% Confidence Interval|Median
2647319|NCT01696058|Secondary|Saint George Respiratory Questionnaire - (Total Score) Based on Combined 1222.51 and 1222.52 Data|The Saint George Respiratory Questionnaire (SGRQ) is designed to measure health impairment in patients with asthma and chronic obstructive pulmonary disease (COPD). It is divided into two parts. Part I produces the Symptoms score (several scales), and Part II the Activity and Impacts scores [dichotomous (true/false) except last question (4-point Likert scale)]. A Total score is also produced with scores ranging from 0 to 100, with higher scores indicating more limitations. Since the SGRQ analysis is based on the combined data from both this study and protocol 1222.51 (NCT01694771), only combined SGRQ results will be included in the latest clinical trial report. Hence there will only be one SGRQ analysis from both studies, which will not appear in the first clinical trial report. For this same reason, another covariate - study - will also be included in the MMRM for SGRQ analysis. The combined data for this outcome measure was pre-specified in both protocols.|12 weeks|FAS with last observation carried forward (LOCF) imputation (combined data from twin studies 1222.51 and 1222.52). Number of patients contributing to models: Tio+Placebo (1055), Tio+Olo 5ug (1039).|||units on a scale (total score)||Standard Error|Least Squares Mean
2647320|NCT01696058|Primary|Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12|Trough FEV1 (Forced expiratory volume in 1 second) response at 12 weeks; defined as change from baseline to Week 12|baseline and 12 weeks|Full Analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.|||L||Standard Error|Least Squares Mean
2647321|NCT01696058|Primary|FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12|FEV1 (Forced expiratory volume in 1 second) AUC0-3h (area under the curve) response at 12 weeks; defined as change from baseline to Week 12. AUC was standardized by dividing by time unit.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks. FAS included all patients in the treated set who had both baseline and at least one post-baseline measurement at or before 12 weeks for any of the co-primary efficacy variables|||Area Under the Curve (L) (standardized)||Standard Error|Least Squares Mean
2647322|NCT01696045|Secondary|Overall Survival Time|Overall Survival time was defined as the time from the start of ipilimumab treatment date to date of death due to any cause. Participants who had not died were censored at the time of last contact (last known alive date).|From date of first treatment to date of death (Assessed up to June 2016, approximately 38 months)|All treated participants|||months||95% Confidence Interval|Median
2647323|NCT01696045|Secondary|Best Overall Response Rate (BORR)|"Best Overall Response Rate (BORR) was defined as the total number of participants with the best overall response of Complete Response (CR) or Partial Response (PR) divided by the total number of treated participants and expressed as a percentage.~CR= Complete disappearance of all non-index lesions. PR= Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions. SD= Does not meet criteria for complete or partial response, in the absence of progressive disease. PD= At least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s)."|From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)|All treated participants|||percentage of participants||95% Confidence Interval|Number
2647324|NCT01696045|Secondary|Progression Free Survival|Progression-Free Survival was defined as the time from the start of ipilimumab treatment to disease progression or death, whichever occurs first. A participant who died without reported progression was considered to have progressed on their date of death. For participants who remained alive and had not progressed, PFS was censored on the date of the last tumor assessment.|From date of first treatment until disease progression or death (Assessed up to June 2016, approximately 38 months)|All treated participants|||months||95% Confidence Interval|Median
2647325|NCT01696045|Secondary|Disease Control Rate (DCR)|"Disease control rate was defined as the percentage of all treated participants with a best overall response of Complete Response (CR), Partial Response (PR), or Stable disease (SD), based on the investigator's assessment per mWHO Criteria.~CR= Complete disappearance of all non-index lesions. PR= Decrease, relative to baseline, of 50% or greater in the sum of the products of the two largest perpendicular diameters of all index lesions. SD= Does not meet criteria for complete or partial response, in the absence of progressive disease. PD= At least 25% increase in the sum of the products of all index lesions (taking as reference the smallest sum recorded at or following baseline) and/or the appearance of any new lesion(s)."|From Day 1 of first subject, first treatment to Day 365 of last subject, first treatment (approximately 36 months)|All treated participants|||Percentage of participants||95% Confidence Interval|Number
2647326|NCT01696045|Primary|Percentage of Participants With Severe Immune-Mediated Adverse Reactions (imARs)|The percentage of participants with severe Immune-mediated Adverse Reactions (imARs) was determined by dividing the number of participants with grade 3 or worse imARs by the total number of treated participants and expressing this number as a percentage. imARs were AEs determined by the investigator to have an immune-mediated etiology, including inflammatory events associated with ipilimumab treatment.|From first dose to 90 days after last dose (Assessed up to June 2016, approximately 38 months)|All treated participants|||percentage of participants||95% Confidence Interval|Number
2647327|NCT01696045|Primary|Overall Survival (OS) Rate at 1 Year|Overall Survival (OS) was defined as the time from the start of ipilimumab treatment date to death due to any cause. If a participant had not died, the participant was censored at the time of last contact (last known alive date). OS rates at 1 year were calculated from both Kaplan-Meier estimates and the proportion of participants alive at 1 year following start of treatment.|1 year following start of treatment (Assessed up to June 2016, approximately 38 months)|All treated participants|||percentage of participants||95% Confidence Interval|Number
2647328|NCT01695993|Primary|Patient Report Nausea Diary|"Nausea and will be measured by a patient report diary completed by patients over a five-day period. Each day is divided into four segments (morning, afternoon, evening, night) in which patients report the severity of nausea and number of vomiting episodes for each period of the day. Severity of nausea is assessed on a 7-point rating scale, anchored at one end by 1 = Not at all nauseated and at the other end by 7 = Extremely nauseated. The outcome variable for the primary analysis was greatest reported nausea from the five day period."|five days||||units on a scale||Standard Deviation|Mean
2647329|NCT01695772|Secondary|Percent Probability Of Being Alive and Disease Free at Months 3, 6, 9, and 12||Months 3, 6, 9, and 12|ITT population|||PP of being alive and disease free||95% Confidence Interval|Median
2647330|NCT01695772|Secondary|Disease Free Survival (DFS)|Disease Free Survival (DFS) was defined as the time from complete resection of liver metastases to disease relapse or death, for participants who achieve complete resection after pre-operative treatment with standard 5-FU based doublet regimen plus bevacizumab.|Complete resection date up to disease relapse or death until data cutoff on 12 May 2016 (up to approximately 3.5 years)|ITT population; Here, number of participants analyzed = participants who underwent study specified surgery. Participants who underwent surgery but did not achieve complete resection were censored.|||months||95% Confidence Interval|Median
2647331|NCT01695772|Secondary|Number of Participants With Disease Relapse or Death||Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall)|ITT population|||participants|||Number
2647332|NCT01695772|Secondary|Percent Probability (PP) of Being Alive and Progression Free at Months 3, 6, 9, 12, 15, and 18|Progressive Disease is defined as a 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions) taking as reference the smallest lesion diameter recorded since the treatment started or appearance of one or more new non-target lesions. PFS was defined as the time from initiation of study treatment to disease progression, as determined by the investigator using RECIST v1.1 criterion, or relapse after resection of liver metastases or death from any cause. The probability was estimated by Kaplan Meier curve analysis.|Months 3, 6, 9, 12, 15, and 18|ITT population; Number of participants analyzed equals (=) number of participants who had surgery.|||PP of being alive and progression free||95% Confidence Interval|Number
2647333|NCT01695772|Secondary|Progression Free Survival (PFS)|Progressive Disease is defined as a 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions) taking as reference the smallest lesion diameter recorded since the treatment started or appearance of one or more new non-target lesions. PFS was defined as the time from initiation of study treatment to disease progression, as determined by the investigator using RECIST v1.1 criterion, or relapse after resection of liver metastases or death from any cause. Kaplan-Meier curves were used to display PFS.|Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall)|ITT population|||months||95% Confidence Interval|Median
2647334|NCT01695772|Secondary|Number of Participants With Disease Progression or Relapse or Death|According to RECIST v1.1 Progressive Disease is defined as a 20 % or greater increase in the sum of the longest diameter of measured lesions (target lesions) taking as reference the smallest lesion diameter recorded since the treatment started or appearance of one or more new non-target lesions.|Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall)|ITT population|||participants|||Number
2647335|NCT01695772|Secondary|Percentage of Participants Achieving Objective Response|Objective response rate was defined as the percentage of participants who achieved either Partial Response (PR) or Complete Response (CR) per Response Evaluation Criteria In Solid Tumors (RECIST) version (v) 1.1. This is defined as the best response recorded from the start of trial treatment until disease progression (or death). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. PR was defined as greater than or equal to [≥] 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Screening until disease progression or death until data cutoff on 12 May 2016 (up to approximately 3.5 years overall)|ITT population|||percentage of participants||95% Confidence Interval|Number
2647336|NCT01695772|Secondary|Percentage of Participants Achieving Incomplete Tumor Resection (R1 Resection)|R1 resection was defined as achievement of incomplete tumor resection with microscopic involvement of a margin after pre-operative chemotherapy plus bevacizumab, as confirmed by pathology. Participants with R1 resections based on assessments performed at time of surgery, 48 hours post-surgery and 4 and 12 weeks after surgery were reported.|At time of surgery (up to 28 weeks), 48 hours post-surgery and 4 and 12 weeks after surgery (up to 40 weeks)|ITT population|||percentage of participants||95% Confidence Interval|Number
2647337|NCT01695772|Primary|Percentage of Participants Achieving Complete Resection (R0 Resection)|R0 resection was defined as complete resection confirmed by pathology after pre-operative chemotherapy plus bevacizumab. Participants with R0 resections based on assessments performed at time of surgery, 48 hours post-surgery and 4 and 12 weeks after surgery were reported.|At time of surgery (up to 28 weeks), 48 hours post-surgery and 4 and 12 weeks after surgery (up to 40 weeks)|ITT population|||percentage of participants||95% Confidence Interval|Number
2647338|NCT01695746|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during this study were reported as AEs. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 24|The safety population was defined as all participants entered into the study.|||Participants|||Number
2647339|NCT01695746|Secondary|Number of Participants Who Received Concomitant Treatment for Anemia|Medications that were used during the study treatment period (from the date of first dose of study medication to the end of the study) were included as concomitant medications. The number of participants taking concomitant medications prescribed for the treatment of anemia (for example iron) is presented.|Up to Week 24|The safety population included all participants entered into the study.|||Participants|||Number
2647340|NCT01695746|Primary|Percentage of Participants Maintaining Hemoglobin Level Within 1 Gram/Deciliter of Baseline Value|Maintenance of Hb levels was to be evaluated for participants on Erythropoiesis stimulating agent (ESA) with Hb levels 10-12 g/dL. None of the participants in the enrolled population had received treatment with other ESAs and had pre-therapy Hb level as 10 g/dL or above. Therefore, the percentage of participants who had received treatment with other ESAs and were maintaining Hb level within 1 g/dL of baseline value during the study could not be evaluated. Baseline is defined as Week 0.|Up to Week 24|The ITT population was the anticipated population for analysis.||||||
2647341|NCT01695746|Primary|Mean Time to Achieve Target Hemoglobin Range (10-12 Gram/Deciliter)|Correction of anemia was evaluated in participants with Hb < 10 gram/deciliter (g/dL). Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The mean time required to achieve target Hb range (10-12 g/dL) was calculated using the following formula: Time to achieve target range = (Date of Hb evaluation when participant achieves target range at first time - visit date of first dosing) + 1.|Up to Week 24|The intent-to-treat (ITT) population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation. The participants who achieved target Hb range (10-12 g/dL) were included in the analysis.|||Weeks||Standard Deviation|Mean
2647342|NCT01695746|Primary|Number of Participants With Co-morbidities at Baseline (Week 0)|Co-morbidities were those medical disorders present in the medical history but unresolved at Baseline. The number of participants with different co-morbidities is presented. Baseline is defined as Week 0.|At Baseline (Week 0)|The safety population included all participants entered into the study.|||Participants|||Number
2647343|NCT01695746|Secondary|Number of Doses of C.E.R.A. Administered by Different Routes|The number of doses of C.E.R.A. administered by the intravenous or subcutaneous route is presented. The number of doses for total population is calculated by summation and presented in table below as per routes of administration.|Up to Week 24|The safety population included all participants entered into the study.|||Doses|||Number
2647344|NCT01695746|Secondary|Mean Dose of C.E.R.A. Administered|The mean dose of C.E.R.A. administered during the study is reported. This accounts for the study drug injected through subcutaneous route at a frequency of every 4 weeks or once a month and every 2 weeks or fortnightly.|Up to Week 24|The safety population included all participants entered into the study.|||mcg per month||Standard Deviation|Mean
2647345|NCT01695746|Secondary|Mean Time Spent in the Hemoglobin Target Range (10 - 12 Gram/Deciliter)|The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 24. The mean time spent (in weeks) by the participants in the target range (10 - 12 g/dL) is presented.|Up to Week 24|The ITT population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation. The participants who achieved target Hb range (10-12 g/dL) were included in the analysis.|||Weeks||Standard Deviation|Mean
2647346|NCT01695746|Secondary|Percentage of Participants Achieving Hemoglobin Target Range (10-12 Gram/Deciliter) at Least Once During the Study|Correction of anemia was evaluated in participants with Hb < 10 g/dL at enrollment. Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The percentage of participants achieving the target Hb range (10-12 g/dL) at least once during the study is presented.|Up to Week 24|The ITT population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation.|||Percentage of participants|||Number
2647347|NCT01695746|Primary|Mean Weight of Participants at Baseline (Week 0)|The mean body weight of the participants was measured and summarized in kg. Baseline is defined as Week 0.|At Baseline (Week 0)|The safety population included all participants entered into the study.|||kg||Standard Deviation|Mean
2647348|NCT01695746|Primary|Mean Height of Participants at Baseline (Week 0)|The mean body height of the participants was measured and summarized in centimeters (cm). Baseline is defined as Week 0.|At Baseline (Week 0)|The safety population included all participants entered into the study.|||cm||Standard Deviation|Mean
2647349|NCT01695668|Primary|Progression of Dry Eye Severity|Dry eye is one of the major symptoms of ocular GVHD in bone-marrow transplant recipients, worsening of dry eye symptoms may be indicative of worsening ocular GVHD conditions.|1 year||||patients with increased dry eye severity|||Number
2647350|NCT01695369|Primary|Subjective Responses for Comfort Rated on a 0-100 Visual Scale.|Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)|Baseline Insertion, 10 Minutes, 5 hours and 10 hours||||units on a scale||Standard Deviation|Mean
2647351|NCT01695330|Secondary|Compare Overall Response Rate (CR + VGPR + PR + MR), Compare Disease Parameters, & Determine Incidence and Severity of Injection-site Reactions.|Compare overall response rate [combined CR + very good partial response (VGPR) + PR + MR] and disease parameters [time to progression, -progression free survival, -time to first response, -duration of response, -overall survival] following treatment with a SC bortezomib-containing combination regimen for MM patients who have demonstrated progressive disease form a prior or different IV bortezomib-containing combination regimen. Determine incidence and severity of injection-site reactions with CS administration of bortezomib by number of patients with injection site reaction specific adverse events.|Subjects eligible for this study will receive treatment with study drug for a maximum of eight 28 day treatment cycles.||2017-10-31|10/2017||||
2647352|NCT01695330|Primary|The Primary Objective of This Study Will be to Investigate the Incidence and Severity of Peripheral Neuropathy Caused by a Prior Intravenous VELCADE-containing Regimen in Comparison to That Caused by a Subcutaneous VELCADE-containing Regimen.|"Definition of incidence: the number of participants enrolled in the study experiencing treatment-emergent peripheral neuropathy. Emergence of peripheral neuropathy is determined via neurological assessment conducted on Day 1 and Day 11 of each treatment cycle as well as during the End of Study visit.~Definition of severity: the severity of any treatment-emergent peripheral neuropathy experienced by a patient on-study. Peripheral neuropathy severity is determined via neurological assessment conducted on Day 1 and Day 11 of each treatment cycle as well as the End of Study visit and is graded on a 0-4 scale based on CTCAE criteria.~Incidence of Peripheral Neuropathy Definition: the number of participants enrolled in the study experiencing treatment-emergent peripheral neuropathy. Emergence of peripheral neuropathy is determined via neurological assessment conducted on Day 1 and Day 11 of each treatment cycle as well as during the End of Study visit."|Subjects eligible for this study will receive treatment with study drug for a maximum of eight 28 day treatment cycles.||||Participants|||Count of Participants
2647353|NCT01695304|Primary|Health Facility Visits for Diarrheal Disease|incidence rate of health facility visits for diarrheal disease per 100 person-week of observation|6 months|incidence rate of health facility visits for diarrheal disease per 100 person-week of observation|||incidence rate per 100 person-weeks|||Number
2647356|NCT01695291|Primary|Yale-Brown Obsessive Compulsive Scale, Child Version (CYBOCS)|The Yale-Brown Obsessive Compulsive Scale, Child Version (CYBOCS) is a semi-structured measure of Obsessive-Compulsive Disorder (OCD) severity with excellent inter-rater reliability, internal consistency, and test-retest reliability. It is validated in those starting at age 7 and used in studies up to age 20. The CYBOCS differs from the adult YBOCS only in its use of simpler language. The total CYBOCS score ranges from 0 to 40, with higher scores indicating more severe symptomatology.|Change from Baseline at 4, 8, and 12 weeks|Due to the early-termination of some participants, not all completed the CYBOCS at Week 12|||units on a scale||Standard Deviation|Mean
2647357|NCT01695239|Secondary|Change From Baseline in Itching Severity Using the Itch NRS|"The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participant's itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction."|Baseline, Week 24|All randomized participants who had baseline psoriatic lesion(s) involving >=3% BSA, baseline itch NRS score and post baseline itch NRS score.|||units on a scale||Standard Error|Least Squares Mean
2647358|NCT01695239|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)|The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Participants achieving PASI 90 were defined as having an improvement of ≥90% in the PASI score compared to baseline. Participants achieving PASI 100 were defined as having an improvement of 100% in the PASI score compared to baseline.|Week 24|All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||percentage of participants|||Number
2647359|NCT01695239|Secondary|Change From Baseline in Leeds Enthesitis Index (LEI)|The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, treatment by visit interaction.|Baseline, Week 24|All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score.|||units on a scale||Standard Error|Least Squares Mean
2647360|NCT01695239|Secondary|Change From Baseline in C-Reactive Protein (CRP)|CRP milligram/liter (mg/L) was measured with a high sensitivity assay at a central laboratory to assess acute phase reactant. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post-baseline CRP data.|||milligram/liter (mg/L)||Standard Error|Least Squares Mean
2647361|NCT01695239|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity VAS|The investigator was asked to give an overall assessment of the severity of the participant's current PsA activity using a 0 to 100 mm horizontal VAS. The scale ranged from 0 no disease activity to 100 extremely active disease activity. The scores were measured to the nearest millimeter from the left. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.|Baseline, 24 Weeks|All randomized participants with baseline and post-baseline physician's global assessment of disease activity data.|||units on a scale||Standard Error|Least Squares Mean
2647362|NCT01695239|Secondary|Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA) VAS|Participants scored their overall assessment of their PsA activity on a 0 to 100 mm horizontal VAS. The scale ranged from 0 (no disease activity) to 100 (extremely active disease activity). The scores were measured to the nearest millimeter from the left. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post-baseline patient's global assessment of disease activity data.|||units on a scale||Standard Error|Least Squares Mean
2647363|NCT01695239|Secondary|Change From Baseline in Patient's Assessment of Pain VAS|The VAS is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, participants scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post-baseline patient's assessment of pain data.|||units on a scale||Standard Error|Least Squares Mean
2647364|NCT01695239|Secondary|Change From Baseline in Swollen Joint Counts (SJC)|SJC is calculated based on swelling response of 66 joints. SJC possible values range from 0 to 66. A lower SJC indicated less joint swelling. A higher SJC indicated more joint swelling. SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post-baseline SJC data.|||joint counts||Standard Error|Least Squares Mean
2647435|NCT01694420|Secondary|Immune Activation as Measured by the Proportion of CD4+ and CD8+ Cells Expressing HLA-DR and CD38+||48 weeks|Data not collected||||||
2647365|NCT01695239|Secondary|Change From Baseline in Tender Joint Counts (TJC)|TJC is calculated based on tenderness response of 68 joints. TJC possible values range from 0 to 68. A lower TJC indicated less joint tenderness. A higher TJC indicated more joint tenderness. TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post-baseline TJC data.|||joint counts||Standard Error|Least Squares Mean
2647366|NCT01695239|Secondary|Percent Change in American College of Rheumatology-N (ACR-N) Score|The ACR-N score is a continuous measure of clinical, laboratory, and functional outcomes that characterizes the percentage of improvement from baseline in disease activity and the lowest of either a) the percent change in tender joint count (TJC) b) the percent change in swollen joint count (SJC), or c) the median percent change of the remaining 5 ACR core criteria. An ACR-N score of X has improvement of at least X% in both TJC and SJC and a median improvement of at least X% in 5 criteria: patient's assessment of arthritis pain, PatGA, PGA, HAQ-DI and hs-CRP. ACR-N is calculated by allowing for negative results which indicate worsening. LS mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment.|Baseline, 24 Weeks|All randomized participants with post-baseline ACR data.|||percent change||Standard Error|Least Squares Mean
2647367|NCT01695239|Secondary|Number of Participants With Treatment Emergent Anti-Ixekizumab Antibodies (TE-ADA) and Neutralizing Antibodies (NAb)|Number of participants with positive treatment emergent anti-ixekizumab antibodies and NAb was summarized by treatment group.|Baseline to Week 24|All randomized participants who received at least 1 dose of ixe and had evaluable anti-ixekizumab antibody measurement at baseline and post baseline or had no evaluable baseline anti-ixekizumab antibody measurements. Immunogenicity data was not collected during the double-blind treatment period for participants in the adalimumab treatment group.|||participants|||Number
2647368|NCT01695239|Secondary|Change From Baseline in in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline axial involvement defined as baseline BASDAI score >4, baseline BASDAI score and post baseline BASDAI score.|||units on a scale||Standard Error|Least Squares Mean
2647369|NCT01695239|Secondary|Change From Baseline in Leeds Dactylitis Index-Basic (LDI-B)|The LDI-B measures the severity of dactylitis. In each digit, the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot measured in mm. Each dactylitic digit was defined by a minimum increase of 10% in circumference over the contra-lateral digit. If the same digits on each hand or foot were thought to be involved, the clinician referred to a table of normative values for a value which was used to provide the comparison. The calculated ratio was multiplied by a tenderness score of 0 (not tender) or 1 (tender). Tenderness was assessed in the area between the joints. The results of each digit were then added to produce a total score. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline dactylitis, baseline LDI-B score and post baseline LDI-B score.|||units on a scale||Standard Error|Least Squares Mean
2647370|NCT01695239|Secondary|Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score Fingernail Involvement at Baseline|The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline fingernail involvement, baseline NAPSI score and post baseline NAPSI score.|||units on a scale||Standard Error|Least Squares Mean
2647371|NCT01695239|Secondary|Percent Change From Baseline in Body Surface Area (BSA)|The investigator evaluated the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who have plaque psoriasis at baseline and who had baseline and post baseline BSA data.|||percent change in BSA||Standard Error|Least Squares Mean
2647372|NCT01695239|Secondary|Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of 0 or 1 and With at Least a 2-point Improvement From Baseline|The sPGA is the physician's determination of the severity of the participant's psoriasis lesions overall at a given time point. Overall lesions were categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis was assessed at a given time point on in which 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.|Week 24|All randomized participants who have plaque psoriasis and sPGA ≥3 at baseline. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||percentage of participants|||Number
2671404|NCT01476267|Primary|Metabolic Profile: Percentage of Free Thiophenol M1 in the Blood Plasma||up to Day 5||||Percentage of Free Thiophenol M1||Standard Deviation|Mean
2647373|NCT01695239|Secondary|Percentage of Participants Meeting the Psoriatic Arthritis Response Criteria (PsARC Modified)|The PsARC is a composite criteria reported in terms of the percentage of participants achieving response according to the following criterion: TJC, SJC, PGA, and PatGA. Overall response is defined by improvement from baseline assessment in 2 of 4 criteria, 1 of which must be a joint count; there must not be worsening in any of the 4 criteria: at least 30% reduction in TJC, at least 30% reduction in SJC, at least a 20 millimeter (mm) reduction in PGA and at least a 20 mm reduction in PatGA which is equivalent to 20 mm reduction. The results from the 2 VAS measures were assessed as a difference from baseline in mm.|Week 24|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||percentage of participants|||Number
2647374|NCT01695239|Secondary|Change From Baseline in Disease Activity Score (28 Diarthrodial Joint Count) Based on C-ReactiveProtein (DAS28-CRP) Measure: Non-Arthritic Disease|The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP measured in milligram/liter (mg/L), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit.|Baseline, Week 24|All randomized participants who had baseline and post baseline DAS28-CRP data.|||units on a scale||Standard Error|Least Squares Mean
2647375|NCT01695239|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) (Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes [PRO])|The QIDS-SR16 is a self-administered 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. Each item scaled from 0 (no symptoms) to 3 (all symptoms). The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline and post baseline QIDS-SR16 data.|||units on a scale||Standard Error|Least Squares Mean
2647376|NCT01695239|Secondary|Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])|SF-36 is a standardized participant-administered measure designed to evaluate 8 domains of functional health and well being: physical and social functioning, physical and emotional role (role-physical, role-emotional) limitations, bodily pain, general health, vitality, mental health with 2 components (physical component score [PCS] and mental component score [MCS]). The PCS and MCS scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants who had baseline and post baseline PCS data. All randomized participants who had baseline and post baseline MCS data.|||units on a scale||Standard Error|Least Squares Mean
2647377|NCT01695239|Secondary|Change From Baseline in Joint Space Narrowing Score (JSN) And Bone Erosion Score (BES)|JSN score (a component of the modified Total Sharp Score [mTSS]) measures the extent of joint space narrowing in peripheral joints. JSN (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. JSN score range is 0 (no narrowing) to 208 (high narrowing). Increase from baseline represents disease progression and / or joint worsening. BES (a component of the [mTSS]) measures the extent of bone erosion in peripheral joints. BES measures the extent of joint erosions (20 joints per hand and 12 joints per foot), with higher scores representing greater damage. Erosion score range is from 0 (no erosion) to 320 (high erosion). LS mean was calculated using linear extrapolation for ANCOVA analysis with treatment, baseline score, geographic region, and baseline cDMARD experience.|Baseline, Week 24|All randomized participants who had baseline and post baseline JSN data. All randomized participants who had baseline and post baseline BES data. Linear extrapolation was used to impute missing data.|||units on a scale||Standard Error|Least Squares Mean
2647378|NCT01695239|Secondary|Change From Baseline in Fatigue Severity NRS Score (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])|"The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing no fatigue and 10 representing as bad as you can imagine. Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction."|Baseline, Week 24|All randomized participants who had baseline and post baseline fatigue NRS data.|||units on a scale||Standard Error|Least Squares Mean
2647379|NCT01695239|Secondary|Change From Baseline in Itching Severity Using the Itch Numeric Rating Scale (NRS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])|"The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participant's itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, and treatment-by-visit interaction."|Baseline, Week 12|All randomized participants who had baseline psoriatic lesion(s) involving >=3% BSA, baseline itch NRS score and post baseline itch NRS score.|||units on a scale||Standard Error|Least Squares Mean
2647406|NCT01694771|Secondary|FVC AUC0-3h Response at 12 Weeks - Defined as Change From Baseline|Forced Vital Capacity (FVC) AUC0-3h response at 12 weeks - defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.|||L||Standard Error|Least Squares Mean
2647380|NCT01695239|Secondary|Change From Baseline in Leeds Enthesitis Index (LEI)|The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, baseline cDMARD experience, visit, treatment by visit interaction.|Baseline, Week 12|All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score.|||units on a scale||Standard Error|Least Squares Mean
2647381|NCT01695239|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100)|The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. Participants achieving PASI 90 were defined as having an improvement of ≥90% in the PASI score compared to baseline. Participants achieving PASI 100 were defined as having an improvement of 100% in the PASI score compared to baseline.|Week 12|All randomized participants with baseline psoriatic lesion(s) involving ≥3% BSA. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||percentage of participants|||Number
2647382|NCT01695239|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: Modified Total Sharp Score [mTSS])|The mTSS measures the extent of bone erosions (20 joints per hand and 12 joints per foot) and joint space narrowing (20 joints per hand and 6 joints per foot), with higher scores representing greater damage. An increase from baseline represents disease progression and / or joint worsening. Scores range from 0-528. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, and baseline cDMARD experience, visit, treatment by visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline mTSS data.|||units on a scale||Standard Error|Least Squares Mean
2647383|NCT01695239|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO])|HAQ-DI is a participant reported questionnaire that measures disease-associated disability (physical function). It consists of 24 questions with 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities. The disability section scores the participant's self-perception on the degree of difficulty (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), covering the 8 domains. The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability. The reported use of special aids or devices and/or the need for assistance of another person to perform these activities is assessed. Least Square (LS) mean was calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment, baseline score, geographic region, baseline conventional disease modifying anti-rheumatic drugs (cDMARD) experience, visit, and treatment-by-visit interaction.|Baseline, Week 24|All randomized participants with baseline and post baseline HAQ-DI data.|||units on a scale||Standard Error|Least Squares Mean
2647384|NCT01695239|Secondary|Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Score|ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.|Week 24|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||percentage of participants|||Number
2647385|NCT01695239|Secondary|Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response|ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.|Week 24|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||percentage of participants|||Number
2647386|NCT01695239|Secondary|Percentage of Participants Achieving ACR20 Response|ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.|Week 12|All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||percentage of participants|||Number
2647387|NCT01695239|Primary|Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20])|ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).|Week 24|All randomized participants. Nonresponder Imputation (NRI) is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.|||percentage of participants|||Number
2647407|NCT01694771|Secondary|Peak FEV1 Response at 12 Weeks - Defined as Change From Baseline|Peak FEV1 (Forced Expiratory Volume in 1 second) response at 12 Weeks - defined as changes from baseline|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.|||L||Standard Error|Least Squares Mean
2647388|NCT01695135|Secondary|DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment|"The Brief Fatigue Inventory (BFI) is a brief participant-reported questionnaire that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. BFI has nine items. Three items ask patients to rate the severity of their fatigue at its worst, usual, and now during normal waking hours, with 0 being no fatigue and 10 being fatigue as bad as you can imagine. Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being does not interfere and 10 being completely interferes. BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue)."|Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])|ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2647389|NCT01695135|Secondary|DB Phase: Percentage of Participants Experiencing Pain Palliation|Percentage of participants experiencing pain palliation were reported. A participant is responder if experienced >=30% reduction in Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity score over 24 hours observed at 2 consecutive evaluations 4 weeks apart without any increase in analgesic usage score (best response). Analgesic usage was scored on a scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain. BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions. It includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.|Approximately up to 3.8 years|ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Population included only participants whose pain score was >= 4 at baseline.|||Percentage of Participants|||Number
2647390|NCT01695135|Secondary|DB Phase: Time to Pain Progression|Time to Pain progression calculated as number of days from date of randomization to date of pain progression. Pain progression- worsening of pain due to metastatic bone disease defined as increase of >=30% in worst pain over past 24 hours on BPI-SF numeric rating scale at 2 consecutive evaluations 4 weeks apart without decrease in analgesic usage score (in 2 corresponding consecutive evaluation in analgesic usage score, if there is missing visit, use existing visit only) or increase in analgesic usage score >=30% at 2 consecutive evaluations 4 weeks apart. BPI-SF is 11-item questionnaire which includes 4 questions that assess pain intensity and 7 questions that assess impact of pain on daily functions. Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores= greater pain. Analgesic usage was scored on scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain.|Approximately up to 3.8 years|ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.|||Days||95% Confidence Interval|Median
2647391|NCT01695135|Secondary|DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment|FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS) (Range 1-156, higher scores better). The FACT-General (FACT-G) is a 28 item Quality of Life (QOL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional (0-24) Well-being. The total range was between 1-108, higher scores better. Functional Assessment of Cancer Therapy-Treatment Outcome Index (FACT-TOI) is derived from the sum of the Physical Well-Being, Functional Well-Being, and Prostate Cancer subscale scores; a sensitive measure of patient-reported health (Range 1-104, higher scores better). PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better).|Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])|ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2647392|NCT01695135|Secondary|DB Phase: Objective Response Rate (ORR)|ORR was defined as the percentage of participants with measurable disease at baseline achieving a complete response (CR) or partial response (PR) according to modified response evaluation criteria in solid tumors (RECIST) criteria. RECIST criteria for CR: disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Approximately up to 3.8 years|ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received. Population included only participants with measurable disease at baseline.|||Percentage of Participants|||Number
2647393|NCT01695135|Secondary|DB Phase: Percentage of Participants Who Achieved PSA Response|Percentage of participants who achieved PSA response (defined as >= 50% PSA decline from baseline) according to PSAWG criteria were reported. PSAWG criteria- Decline from baseline and reach response criteria: >= 50% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: >=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: >=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.|Approximately up to 3.8 years|ITT analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.|||Percentage of Participants|||Number
2647395|NCT01695135|Primary|DB Phase: Time to Prostate-Specific Antigen Progression (PSA)|Time to PSA progression was defined as time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the Prostate Specific Antigen Working Group (PSAWG) criteria. PSAWG criteria- Decline from baseline and reach response criteria: greater than or equal to (>=) 50 percent (%) increase over the nadir and the increase in the absolute-value by at least 5 nanogram per milliliter (ng/mL) (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: >=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: >=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later.|Up to 1.8 years|Intent-to-Treat (ITT) analysis set included all participants randomized into the study and classified according to their assigned treatment group, regardless of the actual treatment received.|||Days||95% Confidence Interval|Median
2647396|NCT01695044|Primary|Overall Radiologic Response|Overall radiologic response was measured prior to the first dose of study drug, at predose of cycle 5, and at the end of study. Imaging techniques used at screening were used throughout the study. The preferred imaging techniques include: bone scan, contrast enhanced CT of chest, contrast enhanced CT of pelvis, and contrast enhanced CT of upper & lower abdomen. Best overall radiologic response (confirmed), target and non-target lesions, was defined as responses in bone, visceral or nodal metastases according to the Modified Response Evaluation Criteria (RECIST 1.1). The best overall radiologic response is the best response recorded from the start of the treatment until disease progression/recurrence (taking, as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject's best response assignment depended on the achievement of both measurement and confirmation criteria.|24 weeks|Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The full modified Intention-to-Treat (mITT) population (n = 119) was examined.|||% of subjects|||Number
2647397|NCT01695044|Primary|CTC Response|Circulating tumor cells (CTC) response was examined at two levels: at least 30% decrease or at least 50% decrease in CTC levels. Response was defined as any decrease from baseline of at least 30% or 50%.|24 Weeks|Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a CTC baseline value and at least one post-baseline value.|||% of responders|||Number
2647398|NCT01695044|Primary|Percentage of Participants With Total Serum PSA Response|Total serum prostate-specific antigen (PSA) response was defined as any decrease from baseline of at least 30% or 50%.|24 Weeks|Both groups must also have received and progressed on abiraterone acetate and/or enzalutamide prior to the study (once these agents were commercially available for use). The population examined was those subjects with a PSA baseline value and at least one post-baseline value.|||% of responders|||Number
2647399|NCT01694966|Primary|To Assess the Detection Efficacy of Chromoendoscopy Performed With 200mg Methylene Blue MMX® 25 mg Tablets Versus Placebo Tablets (White Light Endoscopy) in Terms of the Proportion of Subjects With at Least One Histologically Proven Adenoma or Carcinoma.|Adenoma Detection Rate|+7 days|FAS|||percentage of participants|||Number
2647400|NCT01694771|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Nighttime)|Rescue medication usage - Mean weekly rescue usage during nighttime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||percentage of days||Standard Error|Least Squares Mean
2647401|NCT01694771|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Daytime)|Rescue medication usage - Mean weekly rescue usage during daytime hours. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication by BI, and only the albuterol MDI provided by BI was allowed for rescue medication use. Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||percentage of days||Standard Error|Least Squares Mean
2647402|NCT01694771|Secondary|Rescue Medication Usage - Mean Weekly Rescue Usage (Total Daily)|Rescue medication usage - mean weekly rescue usage (total daily). The baseline for the rescue use was the mean of the observations during the last week of the baseline period. Administration of rescue medication could occur at any point during the trial as deemed necessary by the patient or the investigator. Open label albuterol MDI (100 μg per puff) was provided as rescue medication . Daily, between clinic visits, patients recorded the number of puffs of albuterol in a paper diary.|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||usage (total daily) number of puffs||Standard Error|Least Squares Mean
2647403|NCT01694771|Secondary|Rescue Medication Usage - Percentage of Rescue Free Days|Rescue medication usage - the percentage of rescue free days. The percentage of rescue free days is defined as: number of rescue free days divided by total exposure, multiplied by 100%. The baseline for the number of rescue-free days was defined as the number of rescue-free days observed during the last week of the baseline period (i.e., the 7 days prior to administration of the first dose of randomized treatment).|over 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||percentage of days||Standard Error|Least Squares Mean
2647404|NCT01694771|Secondary|Peak FVC Response at 12 Weeks - Defined as Change From Baseline|Peak FVC response at 12 weeks - defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks.|||L||Standard Error|Least Squares Mean
2647405|NCT01694771|Secondary|Trough FVC Response at 12 Weeks- Defined as Change From Baseline|Trough Forced Vital Capacity (FVC) response at 12 weeks- defined as change from baseline.|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation|||L||Standard Error|Least Squares Mean
2651325|NCT01662778|Secondary|The Concentration of Fluticasone Propionate|The concentration of Fluticasone Propionate in blood following inhalation of the dose will be measured. Cmax will be measured.|4 hours||||pg/ml||Standard Deviation|Mean
2647409|NCT01694771|Primary|FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12|FEV1 (Forced expiratory volume in 1 second) AUC0-3h (area under the curve) response at 12 weeks; defined as change from baseline to Week 12|baseline and 12 weeks|Full analysis set (FAS) with last observation carried forward (LOCF) imputation at 12 weeks. FAS included all patients in the treated set who had both baseline and at least one post-baseline measurement at or before 12 weeks for any of the co-primary efficacy variables|||Area Under the Curve (L)||Standard Error|Least Squares Mean
2647410|NCT01694706|Secondary|Faldaprevir: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 to the last quantifiable drug plasma concentration~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2647411|NCT01694706|Primary|Faldaprevir: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the faldaprevir in plasma~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2647412|NCT01694706|Primary|Faldaprevir: Area Under the Curve Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)|"Area under the concentration-time curve of the faldaprevir in plasma over the time interval from 0 extrapolated to infinity~In this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1.5 hours (h) before drug administration and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 96h and 120h after drug administration|Pharmacokinetic (PK) set: Included all treated subjects that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints.|||[ng*h/mL]||Geometric Coefficient of Variation|Geometric Mean
2647413|NCT01694667|Secondary|Change in Clinical Global Impression - Improvement (CGI-I) Score|"Measures the clinical impression of improvement on a 7-point Likert scale (ranging from 1 - very much improved - to 7 - very much worse) is a commonly used measure of overall improvement in intervention studies of children with ASD. This tool will be completed by the parent and caregiver, and is therefore considered a modified version of the instrument, which is normally completed by a clinician. This is considered an exploratory analysis of this outcome tool since it is being used in a non-standard fashion. The number of participants who responded in each group is the number where the parents reported that their child was improved, much improved, or very much improved."|Baseline, Week 6||||# parents reporting improvement|||Number
2647414|NCT01694667|Secondary|Change in Social Responsiveness Scale (SRS) Score|Social interaction will be assessed with the SRS. This scale examines the presence and extent of autistic social impairment and is administered by parents or teachers of children with ASD. Higher scores are indicative of greater severity. Normative data have been derived from a sample of over 1,600 children.|Baseline, Week 6|||||||
2647415|NCT01694667|Secondary|Aberrant Behavior Checklist - Inappropriate Speech Subscale Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The inappropriate speech subscale is comprised of 4 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 12."|Baseline, Week 6||||units on a scale||Standard Deviation|Mean
2647416|NCT01694667|Secondary|Aberrant Behavior Checklist - Irritability Subscale Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The irritability subscale is comprised of 15 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 45."|Baseline, Week 6||||units on a scale||Standard Deviation|Mean
2647417|NCT01694667|Secondary|Change in Aberrant Behavior Checklist - Stereotypy Subscale Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The stereotypy subscale is comprised of 7 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 21."|Baseline, Week 6||||units on a scale||Standard Deviation|Mean
2647418|NCT01694667|Secondary|Change in Aberrant Behavior Checklist - Lethargy Subscale Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The lethargy subscale is comprised of 16 items. The outcome measure is the change from baseline to six weeks in the scale. Total score ranges from 0 to 48."|Baseline, Week 6||||units on a scale||Standard Deviation|Mean
2647419|NCT01694667|Primary|Change in Aberrant Behavior Checklist - Hyperactivity Subscale (ABC-H) Score|"The Aberrant Behavior Checklist (ABC) is a 58-item survey. Items are rated on a 4-point scale from 0=no problem to 3=major problem. Higher scores indicate greater severity. Scores can be computed for five subscales: hyperactivity, lethargy, stereotypical behavior, irritability, and inappropriate speech. The hyperactivity subscale is comprised of 16 items. The outcome measure is the change from baseline to 6 weeks. The total score ranges from 0 to 48."|Baseline, 6 weeks (3 week value to be collected)||||units on a scale||Standard Deviation|Mean
2647420|NCT01694641|Other Pre-specified|Perinatal Outcome|gestational age at delivery, birth weight,|perinatal outcome assessed after delivery|||||||
2647421|NCT01694641|Other Pre-specified|Time Lapse Score|a score based on 8 observations by time lapse monitoring|the time lapse score is assessed on the day of embryo transfer (day 5 after the egg retrieval)|||||||
2673275|NCT01462877|Secondary|Change in Serum Non-high-density Lipoprotein Cholesterol|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set|||percentage of Non-HDL-C change||Standard Deviation|Mean
2647424|NCT01694563|Secondary|Secondary Efficacy Outcome|The proportion of patients free from AF, regardless of AAD usage (i.e. no episodes lasting > 30 continuous seconds duration of either Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia), as determined by an independent core lab assessment of 48-hour Holter, Zio™ Patch or PPM interrogation recording performed at a minimum of 12,24, and 36 months post-operatively.|12, 24, and 36 months post-operatively|Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage. The participants that met the endpoint are reflected in the Outcome Measure Data Table.|||Participants|||Count of Participants
2647425|NCT01694563|Primary|The Number of Participants Free From Atrial Fibrillation (AF), Atrial Flutter or Atrial Tachycardia While Off Class I and Class III Antiarrhythmic Drugs for at Least 4 Weeks.|The number of participants free from atrial fibrillation (AF), i.e., episodes lasting >30 continuous seconds duration of either AF, atrial flutter or atrial tachycardia while off Class I and III antiarrythmic drugs for at least 4 weeks as determined by core last assessment of a 48 hour Holter, Zio Patch or Pacemaker Implantation (PPM) interrogation recording performed at a minimum of 36 months postoperatively.|36 months post-operatively|Freedom from AF and off antiarrhythmic drugs (AADs) at specific time points. The participants that met the endpoint are reflected in the Outcome Measure Data Table.|||Participants|||Count of Participants
2647426|NCT01694485|Secondary|Percentage of Participants With Sustained Remission at Week 8 and Week 24|"Remission was defined as a total Mayo Score ≤ 2 points, with no individual subscore > 1 point. Sustained remission was defined as achieving the criteria for remission at both week 8 and week 24.~The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment), each graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher scores represent more severe disease status. The total Mayo Score is the sum of the four item scores, with a and ranges from 0 to 12 points. Higher scores represent more severe disease.~The remission rate (percentage of participants with sustained remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline total Mayo Score (adjusted remission rate)."|Week 8 and week 24|The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both non-adjusted and adjusted remission rates were calculated using non-responder imputation, where participants with missing Mayo Score at week 8 or week 16 were counted as non-responders.|||percentage of participants|||Number
2647427|NCT01694485|Secondary|Percentage of Participants With Mucosal Healing at Week 8|"Mucosal healing was defined using the rectosigmoidoscopy subscore of Mayo assessment as absolute subscore for rectosigmoidoscopy of 0 or 1.~Flexible rectosigmoidoscopy was performed as part of the Mayo assessment, graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status.~The healing rate (percentage of participants with mucosal healing) was calculated based on observed data (unadjusted healing rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline rectosigmoidoscopy score (adjusted healing rate)."|Week 8|The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted healing rates were calculated using non-responder imputation, where participants with missing rectosigmoidoscopy scores at week 8 were counted as non-responders.|||percentage of participants|||Number
2647428|NCT01694485|Secondary|Percentage of Participants With Response at Week 8|"Response was defined by a decrease from baseline in the total Mayo Score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore ≥ 1 point or an absolute rectal bleeding subscore = 0 or 1.~The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment), each graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, ranging from 0 to 12 points. Higher scores represent more severe disease.~The response rate (percentage of participants with response) was calculated based on observed data (unadjusted response rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline total Mayo Score (adjusted response rate)."|Baseline and week 8|The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted response rates were calculated using non-responder imputation, where participants with a missing Mayo Score at week 8 were counted as non-responders.|||percentage of participants|||Number
2647429|NCT01694485|Primary|Percentage of Participants With Remission at Week 8|"Remission was defined as a total Mayo Score ≤ 2 points, with no individual subscore > 1 point.~The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease.~The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline total Mayo Score (adjusted remission rate)."|Week 8|The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted remission rates were calculated using non-responder imputation, where participants with a missing Mayo Score at week 8 were counted as non-responders.|||percentage of participants|||Number
2647430|NCT01694433|Secondary|Acne Severity as Assessed With the Investigator's Global Assessment (IGA)|Investigator's Global Assessment (IGA) is a 5-point scale of acne severity, ranging from 0 (Clear) to 4 (Severe)|Weeks 2, 4, 8 & 12|The number of participants analyzed differ from overall number analyzed due to participant withdrawal or missed study visit.|||score on a scale||Full Range|Mean
2647431|NCT01694433|Primary|Lesion Counts (Total, Inflammatory and Non-inflammatory)|Lesion counts will be assessed by one of the investigator physicians or nurse practitioner.|Weeks 2, 4, 8 & 12|The number of participants analyzed differ from overall number analyzed due to participant withdrawal or missed study visit.|||Lesions||Full Range|Mean
2647432|NCT01694420|Other Pre-specified|Number of Participants With Adverse Events Related to Study Drug||48 weeks||||participants|||Number
2647438|NCT01694199|Secondary|Time to First Use of Supplemental Analgesic Medication|The time to first supplemental analgesic use was recorded. This was defined as the time from the initiation of the first study device treatment session (T0) to the time of administration of the first dose of post-T0 supplemental medication.|Treatment with the test device twice per day, over 3 days (7 total treatments)||||Minutes||95% Confidence Interval|Median
2647439|NCT01694199|Secondary|Number of Participants Who Assessed Pain Control at 72 Hours as Good, Very Good, or Excellent|Number of participants who assessed pain control at 72 hours as good, very good, or excellent.|After 3 days of treatment (T0-72 hours)||||Participants|||Count of Participants
2647440|NCT01694199|Secondary|Opioid Consumption Measured in Morphine Equivalents T0-72 Hours|The total quantity of Supplemental Opioid analgesic administered throughout the study was recorded for each Subject. Opioid consumption prior to (T0) was not considered when calculating opioid consumption endpoints.|Treatment with the test device twice per day, over 3 days (7 total treatments)||||Morphine Equivalents||95% Confidence Interval|Median
2647441|NCT01694199|Secondary|TOTPAR-Pain Relief Experienced by Patients T0-72 Hours|"Pain relief was assessed at completion of first study device treatment, 45 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, 6 hours following T0 (±5 mins). Thereafter, pain relief was assessed every 2 hours (±5 mins) between 6AM to 10PM throughout the in-patient treatment period. After 10 PM and before 6AM, pain relief assessments were done every 4 hours. Subjects rated pain relief relative to baseline pain intensity using a categorical scale: 0=none; 1=a little; 2=some; 3= a lot; 4 = complete. Based on these scores, a time weighted pain relief score was calculated, Total Pain Relief (TOTPAR). TOTPAR-Pain Relief = ∑PID x (time(t) - time(t-1)) x PID(i)."|Treatment with the test device twice per day, over 3 days (7 total treatments)||||units on a scale||95% Confidence Interval|Geometric Mean
2647442|NCT01694199|Primary|Overall Analgesic Efficacy (Via SPID 0-72 Hrs)|Sum of time-weighted Pain Intensity Differences (SPID). Pain relief was assessed at completion of first treatment, 45min,60min,90min,2hrs,3hrs,4hrs,6hrs following T0 and every 2hrs between 6AM to 10PM. After 10 PM and before 6AM, pain relief assessments were done every 4hrs. Subjects rated pain relief relative to baseline using a categorical scale: 0=none; 1=a little; 2=some; 3= a lot; 4 = complete. SPIDt = ∑PID x (time(t) - time(t-1)) x PID(i). A more negative SPID value means less pain. Total score of SPID ranged from a min value of -1091550.00 in the active arm and -2120130.00 in the sham arm and a max value of 603060.00 in the active arm and 1077630.00 in the sham arm. No absolute min and max scores were calculated.|Treatment with the test device twice per day, over 3 days (7 total treatments)|P=0.3529|||units on a scale||95% Confidence Interval|Median
2647443|NCT01694186|Primary|To Evaluate the Safety and Efficacy of a FAI Insert|The primary objectives of this study are to evaluate the safety and efficacy of a FAI insert in the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye.|3 years|"Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months (ITT Population)~Overall Summary of Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit (Safety Population)"|||Participants|||Count of Participants
2647444|NCT01694121|Primary|Condom Use/Unprotected Sex - Redefined as Sexual Risk - 6 Month Follow-up|Behavioral assessment of the ratio of protected to total number of sex episodes -- changed to sexual risk inclusive of inconsistent condom use in past 90 days + multiple sex partners + sex trade involvement. Very low sexual risk was defined as having one partner and consistent condom use. Low sexual risk was defined as having multiple partners and consistent condom use OR one partner and no/inconsistent condom use. Medium sexual risk was defined as having multiple partners, no/inconsistent condom use and not participating in transactional sex. High risk was defined as having multiple partners, no/inconsistent condom use, and participating in transactional sex. Participants reporting sex with men in the prior 90 days or who reported that they themselves or (one of) their partner(s) was HIV-positive were excluded from the sexual risk outcome given the known differential HIV risk profile for these subpopulations and small numbers of participants in each.|6 month follow-up|Those retained at 6 mo follow up|||Participants|||Count of Participants
2647445|NCT01694121|Secondary|Non-viral STI - 6 Month Follow-up|HIV and STI testing via blood and urine tests was conducted; outcome based on non-viral STI to allow for incidence assessment and change over time|6 month follow-up|Participants retained at 6mo follow-up|||Participants|||Count of Participants
2647446|NCT01694121|Secondary|Non-viral STI - 12 Month Follow-up|HIV and STI testing via blood and urine tests was conducted; outcome based on non-viral STI to allow for incidence assessment and change over time|12 month follow-up|Participants retained at 12mo follow-up|||Participants|||Count of Participants
2647447|NCT01694121|Primary|Condom Use/Unprotected Sex - Redefined as Sexual Risk - 12 Month Follow-up|Behavioral assessment of the ratio of protected to total number of sex episodes -- changed to sexual risk inclusive of inconsistent condom use in past 90 days + multiple sex partners + sex trade involvement. Very low sexual risk was defined as having one partner and consistent condom use. Low sexual risk was defined as having multiple partners and consistent condom use OR one partner and no/inconsistent condom use. Medium sexual risk was defined as having multiple partners, no/inconsistent condom use and not participating in transactional sex. High risk was defined as having multiple partners, no/inconsistent condom use, and participating in transactional sex. Participants reporting sex with men in the prior 90 days or who reported that they themselves or (one of) their partner(s) was HIV-positive were excluded from the sexual risk outcome given the known differential HIV risk profile for these subpopulations and small numbers of participants in each.|12 month follow-up|Those retained at 12 mo follow up|||Participants|||Count of Participants
2647461|NCT01694108|Secondary|Standardized Head Circumference at 13 Months of Age|To test if infants who get the BCG vaccine at birth respond in head circumference. The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|13 months|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.|||Head circumference z-score||Standard Deviation|Mean
2647558|NCT01692691|Primary|Progression Free Survival|Progression free survival of patients with Stage IV melanoma who have had disease progression on at least one prior systemic therapy|8 weeks|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
2647448|NCT01694108|Other Pre-specified|Quality of Communication and Information|"To test that the use of telephone and internet was acceptable in the study population using the Quality of Informed Consent (QuIC) questionnaire. The questionnaire was divided into six categories; five on study comprehension and one on satisfaction with the information process. The items in the first five categories could be answered with yes, no or do not know. The last category was rated on a 7-point Likert scale, with 1 being very dissatisfied and 7 being very satisfied. The primary outcome was the sum of the score for comprehension items and satisfaction items. Comprehension items were scored 1 point for each correct answer and 0 points for each incorrect answer. Satisfaction items were scored as rated on the 7-point Likert scale. Total score ranged from 7 to 69 points, comprehension score from 0 to 20 points and satisfaction score from 7 to 49 points. The higher score, the better comprehension and satisfaction."|2 days after the information was given|This is a small, separate sub-study. 59 + 59 participants had sufficient follow-up data to participate in the analysis.|||Score on QuIC scale||Inter-Quartile Range|Mean
2647449|NCT01694108|Other Pre-specified|Decisional Conflict Scale Score|After parents having made the decision about whether to accept vaccination of their newborn through participation in The Danish Calmette Study, O'Connor's Decisional Conflict Scale was used to identify decisional conflicts. The score ranges from 0 (no decisional conflict) til 100 (maximum decisional conflict). Scores lower than 25 are associated with implementing decisions; scores exceeding 37.5 are associated with decision delay or feeling unsure about implementation; so a low score reflects a low level of doubt about the decision about participation/decline participation in the trial, and a high score reflects a high level of doubt.|The decisional conflict score was measured before randomisation|This outcome was a sub-study to The Danish Calmette Study with 667 participating mothers and 320 declining mothers.|||decisional conflict score||Inter-Quartile Range|Mean
2647450|NCT01694108|Secondary|Number of Events of Febrile Convulsions|To test that Danish infants who get the BCG vaccine at birth develop less febrile convulsions at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.|||Events|||Number
2647451|NCT01694108|Secondary|Number of Events of Acute Otitis Media|To test that Danish infants who get the BCG vaccine at birth develop less acute otitis media at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.|||Events|||Number
2647452|NCT01694108|Secondary|Number of Events With Diarrhoea and Vomiting|To test that Danish infants who get the BCG vaccine at birth develop less episodes with diarrhoea and vomiting at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.|||Events|||Number
2647453|NCT01694108|Secondary|Number of Events of Febrile Episodes|To test that Danish infants who get the BCG vaccine at birth get less febrile episodes at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.|||Events|||Number
2647454|NCT01694108|Secondary|Number of Events of Pneumonia|To test that Danish infants who get the BCG vaccine at birth get less pneumonia at 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.|||Events|||Number
2647455|NCT01694108|Secondary|Number of Events of Common Cold|To test that Danish infants who get the BCG vaccine at birth experience less events of common cold until 13 months of age than non-BCG-immunised infants.|13 months of age|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.|||Events|||Number
2647456|NCT01694108|Secondary|Number of Participants With Antibody Concentration (AC) Against Tetanus of > 0.1 IU/mL|To test the tetenus antibody response in BCG-vaccinated vs. non-BCG vaccinated children following routine immunisation against tetanus at 3, 5 and 12 months of age in blood samples obtained 13 months of age.|13 months of age|This outcome was a sub-study with 158 participants. Antibody concentration (AC) of > 0.1 IU/mL was considered protective|||participants|||Number
2647457|NCT01694108|Secondary|Interferon Gamma Response|To test that infants who receive the BCG at birth respond in interferon-gamma response upon stimulation with BCG. The interferon gamma response was defined as a value above the cut-off value of 107 pg/ml.|13 months of age|This is a sub study using bloodsamples. Only a small sub population from the overall trial participated.|||participants|||Number
2647458|NCT01694108|Secondary|Monocyte Count 4 Days After Randomisation/Vaccination|To test if infants who receive the BCG at birth respond in monocyte count measured as geometric mean (GM) cell concentrations (GM*10^9 cells/L).|4 days after randomisation/vaccination within 7 days after birth|This was a sub study among 153 children with blood-samples at 4 days after randomisation/vaccination.|||Cell concentrations (GM*10^9 cells/L)||95% Confidence Interval|Geometric Mean
2647459|NCT01694108|Secondary|Leucocyte Count 4 Days After Randomisation/Vaccination|To test if infants who receive the BCG at birth respond in leucocyte count (white blood cell count) measured as geometric mean (GM) cell concentrations (GM*10^9 cells/L).|4 days after randomisation/vaccination within 7 days after birth|This was a sub study among 153 children with blood-samples at 4 days after randomisation/vaccination.|||cell concentrations (GM*10^9 cells/L)||95% Confidence Interval|Geometric Mean
2647460|NCT01694108|Secondary|Thymic Gland Size at 3 Months of Age|To test that infants who receive the BCG at birth respond in thymic gland size defined by ultra sound examination. First, the thymus gland was identified in a horizontal scanning plane and the largest transverse diameter of the thymus was obtained. Second, in a sagittal scanning plane, the area of the largest lobe was assessed. Both measurements were obtained twice, and in case of more than 15% difference, both measurements were repeated. The mean of the two measurements were multiplied and defined as the thymic index.|3 months of age|This outcome was a sub-study to The Danish Calmette Study with 301 (BCG 153, Control 148) participating children.|||Thymic index||95% Confidence Interval|Mean
2647508|NCT01693185|Secondary|Participants Assumed to Feel Frequent Pain|"patients sound Ah at feeling pain during colonosocpy: if a patients sounds Ah > 6 times, the patient was assumed to feel frequent pain."|during and after colonoscopy||||participants|||Number
2647462|NCT01694108|Secondary|Length at 13 Months of Age|To test if infants who get the BCG vaccine at birth respond in length. The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|13months|This analysis only includes children with available follow-up data. As opposed to the primary outcome, follow-up for this outcome was lower than 100%.|||Length z-score||Standard Deviation|Mean
2647463|NCT01694108|Secondary|Food Allergy|Number of participants with food allergy diagnosed by a physician and mentioned in the telephone interview at 13 months of age|13 months|This analysis only includes children with available follow-up telephone interview data. As opposed to the primary outcome, follow-up was lower than 100%.|||participants|||Number
2647464|NCT01694108|Secondary|Episodic Viral Wheeze|Number of participants diagnosed with episodic viral wheeze by a physician and treated with anti-asthmatic medicine according to the telephone interview.|13 months|This analysis only includes children with available follow-up telephone interview data. As opposed to the primary outcome, follow-up was lower than 100%.|||participants|||Number
2647465|NCT01694108|Secondary|Standardized Weight, Length and Head Circumference of Premature Children at 13 Months|The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|13 months of age|Premature children born with gestational age 32-36 weeks. This analysis only includes children from a particular subgroup (premature children, N = 144), who had with available follow-up data. As opposed to the primary outcome, follow-up was lower than 100%.|||z-score||Standard Deviation|Mean
2647466|NCT01694108|Secondary|DTaP-IPV-Hib Vaccination Coverage at 12 Months of Age|To test that infants who get the BCG vaccine at birth has unaffected coverage with the subsequent 3rd diphtheria, tetanus, acellular pertussis, polio, Haemophilus influenzae type b (DTaP-IPV-Hib) vaccination scheduled to 12 months of age according to the Danish child vaccination programme. Since we did not expect all children to get their immunizations exactly at 12 months of age, the children were followed up until 13-months of age.|13 months of age|Per-protocol analysis excluding 11 children randomised to BCG who did not receive the vaccine, and 36 children randomised to control who received the BCG vaccine.|||participants|||Number
2647467|NCT01694108|Secondary|Psychomotor Development in Premature Infants|To test that premature infants with gestational age less than 37 weeks who get the BCG vaccine at birth have unaffected psychomotor development measures: ASQ: Ages and stages questionnaire - a parent reported questionnaire that measures child psychomotor development. Total range of ASQ score: 0 to 300 points. Higher scores indicate higher level of psychomotor development.|13 months of age|This analysis only includes children from a particular subgroup (premature children, N = 144), who had with available follow-up data. As opposed to the primary outcome, follow-up was lower than 100%.|||Score on ASQ scale||Standard Deviation|Mean
2647468|NCT01694108|Secondary|Standardized Weight at 13 Months|To test that infants who get the BCG vaccine at birth respond in weight.The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|13 months of age|This analysis only includes children with available follow-up data from telephone interviews or clinical examinations. As opposed to the primary outcome, follow-up was lower than 100%.|||Weight z-score at 13 months||Standard Deviation|Mean
2647469|NCT01694108|Secondary|Specific IgE|Number of participants with specific IgE (Phadiatop Infant) above the clinical cut-of level of 0.35.|13 months of age|This analysis includes children who participated with blood samples for this sub-study regarding specific IgE.|||participants|||Number
2647470|NCT01694108|Secondary|Atopic Dermatitis|"To test if BCG vaccination within 7 days after birth influence the risk of atopic dermatitis defined by clinical examination at 13 months of age using scoring atopic dermatitis (SCORAD) or by parental report of physician diagnosed atopic dermatitis in the telephone interview at 13 months of age."|13 months of age|This analysis includes children with follow-up data from clinical examination or telephone interview. As opposed to the register-based primary outcome, adherence to telephone-interview and clinical examination was slightly lower than 100%.|||participants|||Number
2647471|NCT01694108|Secondary|Antibiotics|To test that infants who get the BCG vaccine at birth are prescribed less antibiotics during early childhood than non-BCG-immunised infants. Use of antibiotics was defined as one or more precriptions of systemic antibiotics (ATC groups J01, J02, J05, all subgroups inclusive).|0-15 months of age|Intention-to-treat|||participants|||Number
2647472|NCT01694108|Primary|All-cause Hospitalisations|To test that infants who get the BCG vaccine at birth experience 20% fewer hospitalisations in early childhood than non-BCG-immunised infants.|0-15 months of age|Intention-to-treat|||Events|||Number
2647473|NCT01693900|Secondary|Patient Satisfaction With Postoperative Pain Control|Patient satisfaction with postoperative pain control, using a 10 point Likert scale where 1=extremely dissatisfied and 10= extremely satisfied. Patients were called 3 weeks post-op to determine pain control satisfaction.|At the 3 week post-op visit|Data was obtained for the 25 patients in the pre-operative group and 22 patients in the intra-operative group who responded to 3-week followup phone calls.|||units on a scale||Standard Deviation|Mean
2647474|NCT01693900|Secondary|Incidence of Adverse Events|Measure is count of participants experiencing any adverse event. Adverse events will be reported by the patient (or when appropriate, staff personnel) during hospitalization.|From the signature on the informed consent document for the duration of the hospital stay, an expected average of 2 - 3 days.|Data lost for one participant in Intra-operative FICB group leaving 24 analyzed.|||Participants|||Count of Participants
2647475|NCT01693900|Primary|Postoperative Pain During Recovery|Pain assessments were made by the subject using a 10.0 cm VAS (scale 1-100 where 1=minimal pain and 100= worst pain imaginable) prior to any request for pain medication. Up to 40 values per patient were averaged.|From discharge from PACU until discharge from hospital, an average of 2-3 days|Data not available for 1 patient in Pre-operative ultrasound FICB group and 3 patients Intra-operative FICB group|||units on a scale||Inter-Quartile Range|Median
2647476|NCT01693900|Primary|Postoperative Pain During PACU Admission|"Pain assessments will be made by the subject using a 10.0 cm Visual-Analog scale (VAS) (scale 1-100 where 1=minimal pain and 100= worst pain imaginable) as follows at each time point:~Baseline assessment in Preoperative area~Upon arrival to the post-anesthesia care unit (PACU)~Every 15 min (+/- 2 minutes) thereafter and prior to any request for pain medication until PACU discharge All pain scores per subject from the time of PACU admission until discharge from PACU will be averaged to obtain one data point per subject."|From time of PACU admission until discharge from PACU, an average of 2 hours|Data lost for one participant in Intra-operative FICB group leaving 24 analyzed.|||units on a scale||Inter-Quartile Range|Median
2647477|NCT01693653|Secondary|Safety|The study was terminated. No data were collected for this outcome measure.|9 moths|Terminated due to low enrollments. Data for 1 subject not analyzed.||||||
2647478|NCT01693653|Secondary|BDCAF|The study was terminated. No data were collected for this outcome measure.|9 months|Terminated due to low enrollments. Data for 1 subject not analyzed.||||||
2647479|NCT01693653|Secondary|MDHAQ|The study was terminated. No data were collected for this outcome measure.|9 months|Terminated due to low enrollments. Data for 1 subject not analyzed.||||||
2647480|NCT01693653|Secondary|BSAS|The study was terminated. No data were collected for this outcome measure.|9 months|Terminated due to low enrollments. Data for 1 subject not analyzed.||||||
2647481|NCT01693653|Secondary|Gential Ulcer Pain|The study was terminated. No data were collected for this outcome measure.|9 months|Terminated due to low enrollments. Data for 1 subject not analyzed.||||||
2647482|NCT01693653|Secondary|Oral Ulcer Pain|The study was terminated. No data were collected for this outcome measure.|9 months|Terminated due to low enrollments. Data for 1 subject not analyzed.||||||
2647483|NCT01693653|Secondary|Treatment Failures|The study was terminated. No data were collected for this outcome measure.|9 months|Terminated due to low enrollments. Data for 1 subject not analyzed.||||||
2647484|NCT01693653|Secondary|Oral Ulcers|The study was terminated. No data were collected for this outcome measure.|9 months|Terminated due to low enrollments. Data for 1 subject not analyzed.||||||
2647485|NCT01693653|Secondary|Genital Ulcers|The study was terminated. No data were collected for this outcome measure.|9 months|Terminated due to low enrollments. Data for 1 subject not analyzed.||||||
2647486|NCT01693653|Primary|Primary Outcome|The study was terminated. No data were collected for this Outcome Measure.|9 months|The study was terminated. No data were collected for this Outcome Measure.||||||
2647487|NCT01693614|Secondary|Overall Survival - Median (FAS)|Overall survival (OS) is the time from treatment start to the date of death due to any cause. Estimates done by cohort using Kaplan-Meier method with 95% confidence intervals|Baseline up approximately 44 months||||months||95% Confidence Interval|Median
2647488|NCT01693614|Secondary|Percentage of Participants - Overall Survival- Kaplan Meier Estimates (FAS)|Overall survival (OS) is the time from treatment start to the date of death due to any cause. Estimates done by cohort using Kaplan-Meier method with 95% confidence intervals|Baseline up to approximately 18 months||||percentage of participants||95% Confidence Interval|Number
2647489|NCT01693614|Secondary|Overall Survival (OS) - Percentage of Participants With OS Events (FAS)|Overall survival (OS) is the time from treatment start to the date of death due to any cause. Participants not known to have died were censored at the date of their last visit|Baseline up to approximately 44 months||||percentage of participants|||Number
2647490|NCT01693614|Secondary|Duration of Response for Diffuse Large B-cell Lymphoma (DLBCL), and Follicular Lymphoma (FL) Cohorts (FAS)|Duration of response is the time from the date of first occurrence of complete response (CR) or partial response (PR) to the date of the first documented progressive disease (PD) or death due to any cause|Baseline up to approximately 18 months|Number analyzed represents participants satisfying criteria for duration of response|||months||95% Confidence Interval|Median
2647491|NCT01693614|Secondary|Progression- Free Survival (PFS) Based on Investigator Assessment (FAS)|Progression-free survival (PFS) is the time from the date of treatment start to the date of the first documented progressive disease (PD) or death due to any cause using Kaplan-Meier method by cohort.|Baseline up to approximately 44 months||||months||95% Confidence Interval|Median
2647492|NCT01693614|Primary|Overall Response Rate (ORR) and Disease Control Rate (DCR) Per Investigator at 6 Months (FAS)|Overall Response rate is the percentage of patients in a cohort who experienced either complete response (CR) or partial response (PR) during their follow-up after treatment start divided by the total percentage of patients included in the corresponding cohort according to Cheson criteria The analysis for each cohort was based on an exact binomial test comparing the ORR to the reference level of 10% (null hypothesis) in the FAS. The test for each cohort used a significance level of 5%. The ORR was presented together with an exact 95% Clopper- Pearson confidence interval. Disease Control Rate (DCR progressive. Disease Control Rate (DCR) was the percentage of patients with CR, PR or SD (stable disease). Patients for whom the best response after treatment start was missing, unknown (UNK) or progressive disease (PD) were considered non-responders and were counted in the denominator for the estimation of the ORR|Baseline up to 6 months|different numbers represents satisfying particular criteria|||percentage of participants||95% Confidence Interval|Number
2647493|NCT01693523|Secondary|Relationship Between Dynamic Changes in Inflammation Biomarkers and Symptom Outcomes, Controlling for the Grouping Variables (Tumor Markers, Weight Loss), Evidence of Infection, ECOG PS, Age and Gender Examined||3 weeks|The blood sample collection was an optional procedure for the participants data were not collected.||||||
2647509|NCT01693185|Primary|The Recovery Time|"Time from completing the colonoscopy to achieving Aldrete score 10 in the recovery unit~Aldrete score~Respiration: Able to take deep breath and cough = 2, Dyspnea/shallow breathing = 1, Apnea = 0~O2 saturation: Maintains > 92% on room air =2, Needs O2 inhalation to maintain O2 saturation > 90% =1 , O2 saturation < 90% even with supplemental oxygen =0~Consciousness: Fully awake= 2, Arousable on calling = 1, Not responding = 0~Circulation: BP +/- 20 mm Hg preop =2, BP +/- 20-50 mm Hg preop =1, BP +/- 50 mm Hg preop =0~Activity: Able to move 4 extremities = 2, Able to move 2 extremities = 1, Able to move 0 extremities = 0~To estimate the required sample size, we conducted a pilot study to measure the recovery of 10 patients in each of groups-MM and -R before the present study. The means and standard deviations were 22.5 ± 9.5 and 7.5 ± 9.2 min respectively. We wished to be able to distinguish a difference of 7.5 min, thus half of the observed difference."|every 5 minutes after completing colonoscopy up to 30 min||||minute||Inter-Quartile Range|Median
2647494|NCT01693523|Primary|Average Area Under the Curve (AUC) of Apriori Selected MDASI Symptoms|Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference using the MD Anderson Symptom Inventory (MDASI). It is a measure of symptom burden, which includes symptom severity and how they interfere with daily functioning. For this study, the sub scale is the average of the 5 pre-selected items namely fatigue, pain, disturbed sleep, lack of appetite and drowsiness. This subscale ranges from 0 to 10. The primary outcome is the average of the 70-day area (10 week study) under the curve for the sub scale. AUC ranges from 0 (0*70) to 700 (10*70). To put this into perspective, the average AUC for the placebo group of 200.8 can also be thought of as 2.87 (200.8/70) on a 0 to 10 scale over the 70 day study period. Lower values represent better outcome. Higher values represent worse outcome.|AUC from baseline to 2 weeks|Of the 44 randomized patients, 30 (68% were evaluable for the primary efficacy analysis).|||Units on a scale *days||Standard Deviation|Mean
2647495|NCT01693484|Primary|Perfusion Data Infection Wound Healing Complication|correlation of multiple absolute and relative data points acquired from near infra red spectroscopy compared to clinical postoperative infection or wound healing complication following lateral approach calcaneus fracture|3 months postoperative|unable to complete analysis as correlation between clinical and ICG near infra red data acquisition could not be completed do to unexpected lack funding required to pair and analyze extremely large data sets with clinical information as well as too few numbers of patients||||||
2647496|NCT01693367|Secondary|WOMAC|To assess pain, stiffness, and physical function|Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.||||||
2647497|NCT01693367|Secondary|Full Weight-bearing Status|"Assessment of the timepoint when the patient :~can bear the whole body weight on the affected leg at single-leg-stance for 3 seconds~can walk without walking aid~has no intake of analgesics~has a pain level experienced at the fracture site during weight bearing over two consecutive measurements with a value of ≤ 3 as measured on a 0-10 numeric rating scale (NRS), where 0 = no pain and 10 = worst pain imaginable"|weekly measurement at home|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.||||||
2647498|NCT01693367|Secondary|Range of Motion (ROM)|Assessment of passive ROM of the knee (flexion - extension)|6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.||||||
2647499|NCT01693367|Secondary|Quality of Life (EuroQol-5D)||Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.||||||
2647500|NCT01693367|Secondary|Timed Up-and-go Test (TUG)|"The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command ready - go and stopped when the seated position is reached again."|12 weeks ± 7 days, 6 months ± 30 days|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.||||||
2647501|NCT01693367|Primary|Western Ontario and McMaster Universities Index (WOMAC)|To assess pain, stiffness, and physical function|12 months after surgery|Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available.||||||
2647502|NCT01693250|Other Pre-specified|Diastolic Blood Pressure|Systolic blood pressure and diastolic blood pressure were measured by using a mercury sphygmomanometer with specific cuff size appropriate for adolescents (Baumanometer, W. A. Baum Co., Copiague, New York). After participants sat for 10 minutes, blood pressure was measured twice in the adolescent's right arm; blood pressures were measured to the nearest 2 mmHg. Average score of two measures was used.|baseline and 6 months|Adolescents who are overweight or obese were invited to participate in this study,|||mmhg||Standard Deviation|Mean
2647503|NCT01693250|Primary|Body Mass Index (BMI)|Participants' BMI was determined by dividing body mass (weight) by height squared (kg/m2). Adolescents' weight and height were measured while the adolescents wore light-weight clothes and no shoes. For BMI, adequate sensitivity and specificity has been reported in children and adolescents, with sensitivity ranging from 29% to 88% and specificity ranging from 94% to 100%.|baseline and 6 months||||kg/m^2||Standard Deviation|Mean
2647504|NCT01693185|Secondary|Indigence of Patient's Recall|The numbers of patients who recalled instructions and explanations given during colonoscopy|after colonoscopy||||participants|||Number
2647505|NCT01693185|Secondary|Endoscopist Satisfaction|endoscopist's satisfaction after colonoscopy in visual analogue scale 100 mm|5 min after the colonoscopy||||units on a scale||Inter-Quartile Range|Median
2647506|NCT01693185|Secondary|Patient's Distress Score|patients' distress in visual analogue scale 100 mm minimal distress=0, maximal distress=100|5 min after the end of colonoscopy||||units on a scale||Inter-Quartile Range|Median
2647507|NCT01693185|Secondary|Bispectra Lindex Score|Bispectral index (BIS) score 0-100 maximal sedation=0, maximal sedation=100|every 5 min during and after colonoscopy||||units on a scale||Full Range|Median
2647510|NCT01693120|Secondary|Number of Participants With Pulmonary Vein Stenosis|Greater than 70 percent reduction in the luminal diameter in any one or more of the pulmonary veins following a Phased RF ablation procedure|3 months|Number of subjects selected for participation in the pulmonary vein assessment cohort with baseline and 3-month evaluable magnetic resonance imaging scans of the pulmonary veins|||Participants|||Count of Participants
2647511|NCT01693120|Secondary|Number of Participants With Acute Procedural Success|Acute procedural success defined as: (1) Only Phased RF ablation catheters used in the left atrium, (2) all targeted pulmonary veins isolated, (3) all complex fractionated atrial electrograms and high frequency intracardiac electrogram amplitudes were mapped and ablated, and (4) sinus rhythm was restored at the end of the ablation procedure (with or without cardioversion)|30 minutes|All subjects who underwent a Phased RF study procedure|||Participants|||Count of Participants
2647512|NCT01693120|Secondary|6-month Post-procedure Effectiveness|For a participant, the 6-month effectiveness defined as meeting all of the following criteria: (1) acute procedural success, (2) greater than 90% reduction in atrial fibrillation/atrial flutter episodes lasting longer than 10 minutes as measured by 48-hour ambulatory ECG, (3) No amiodarone use for 90 days and no class I or class III antiarrhythmic drugs for at least 60 days prior to 6-month ambulatory ECG, and (4) free from direct current cardioversion for at least 60 days prior to the 6-month ambulatory ECG|6 months|Of the 129 subjects with an index Phased RF ablation procedure, 114 were evaluable for the 6-month efficacy objective. There were 15 subjects that were not included in the 6-month efficacy objective; 13 due to study exit prior to the 6-month visit and 2 due to no 6-month ambulatory ECG|||Participants|||Count of Participants
2647513|NCT01693120|Primary|Number of Participants With Procedure and/or Device Related Stroke|A stroke with with a symptom onset date within 30 days of an ablation procedure where at least one Phased RF ablation catheter was deployed into the left atrium considered related to the procedure and/or the investigational device by the independent clinical events committee|30 days|All subjects with a Phased RF ablation procedure who did not have a non-investigational catheter placed in the left atrium|||Participants|||Count of Participants
2647514|NCT01693068|Secondary|Number of Subjects With Clinically Significant Change From Baseline in Laboratory Parameter, Vital Signs, Electrocardiogram (ECG) and Ophthalmologic Findings|Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.|Baseline up to cut-off date (04-Jul-2015)|Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment.|||subjects|||Number
2647515|NCT01693068|Secondary|Number of Subjects With Adverse Events (AEs) of Special Interest|Adverse events of special interest included ocular retinal vein occlusion, serious retinal detachment or similar retinal abnormality characterized by accumulation of serous fluid in the retina, creatine phosphokinase (CPK) elevation and isoenzyme TEAE of Special Interest (Grade >=2) and acute renal failure (Grade >=2). Subjects were presented under 3 reporting groups: Dacarbazine group: for subjects who received at least 1 dose of dacarbazine; Pimasertib group: for subjects who received at least 1 dose of pimasertib; Pimasertib (Crossover) group: for subjects who were initially randomized and received dacarbazine, but crossed over to pimasertib treatment on progression of their disease.|Baseline up to cut-off date (04-Jul-2015)|Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment.|||subjects|||Number
2647516|NCT01693068|Secondary|Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Discontinuation or TEAEs Leading to Death|AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 33 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs. TEAEs were to be reported separately for dacarbazine, pimasertib and pimasertib (crossover) reporting arms.|Baseline up to cut-off date (04-Jul-2015)|Safety analysis set (SAF) consisted of all subjects who received at least 1 dose of any trial treatment.|||subjects|||Number
2647517|NCT01693068|Secondary|Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Trial Outcome Index (FACT-M TOI) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)|QoL assessed using FACT-M assessment tool. This includes 27-item FACT-G questionnaire which consists of 24 questions; 7 relating to PWB, 7 relating to SWB, 6 relating to EWB and 7 relating to FWB. Also, it includes melanoma-specific subscale consists of 16 questions for MS and 8 questions for the MSS. Each of these questions could have a response of Not at all, a little bit, somewhat, quite a bit and very much. The responses were given a value between 0 and 4 with 4 being best response. The FACT-M Trial Outcome Index (FACT-M TOI) ranges from 0 to a high of 120 and is derived as: FACT-M TOI = PWB Score + FWB Score +MS Score. Higher scores represent a better quality of life.|Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32, 33, 35, 36, 37 and EOT (up to cut-off date [04-Jul-2015])|ITT analysis set. Here “Number of Subjects Analyzed” = subjects evaluable for this outcome and “Number Analyzed” = subjects evaluable at specified time points for each arm, respectively. There were no subjects analyzed at certain time points (that is, Number Analyzed = 0) because there was no data collected for respective arms at those time points.|||units on a scale||Standard Deviation|Mean
2647526|NCT01693029|Secondary|Mean Weekly Dose During Evaluation Period (Week 21-28)|Mean weekly study drug dose during evaluation period (Week 21-28)|Week 21-28|The intent-to-treat (ITT) population consists of all randomized patients who were exposed to treatment with study drug for at least four weeks and have at least one Hb value available at week 4 or later. Following the intent-to-treat principle, patients are analyzed according to the treatment they were assigned to at randomization.|||international units||Standard Deviation|Mean
2673276|NCT01462877|Secondary|Change in Serum High-density Lipoprotein Cholesterol|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set|||percentage of HDL-C change||Standard Deviation|Mean
2647518|NCT01693068|Secondary|Change From Baseline in Subject-reported Quality of Life Assessed by Functional Assessment Cancer Therapy - Melanoma Total Score (FACT-M TS) at Day 1 of Pre-Specified Cycles and End of Treatment (EOT)|QoL assessed using Function Assessment Cancer Therapy-melanoma (FACT-M) assessment tool. This includes 27-item FACT-General (FACT-G) questionnaire which consists of 24 questions;7 relating to physical well-being (PWB),7 relating to social/family well-being (SWB),6 relating to emotional well-being (EWB) and 7 relating to functional well-being (FWB). Also, it includes melanoma-specific subscale consists of 16 questions for Melanoma Subscale (MS) and 8 questions for Melanoma Surgery Scale (MSS).Each of these questions could have a response of Not at all, a little bit, somewhat, quite a bit and very much. The responses were given a value between 0 and 4 with 4 being best response. The FACT-M Total Score (FACT-M TS) ranges from 0 to 172 and is derived as follows: FACT-M TS= PWB Score + SWB Score + EWB Score + FWB Score + MS Score. Higher scores represent a better quality of life.|Baseline, Day 1 of Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32, 33, 35, 36, 37 and EOT (up to cut-off date [04-Jul-2015])|ITT analysis set. Here “Number of Subjects Analyzed” = subjects evaluable for this outcome and “Number Analyzed” = subjects evaluable at specified time points for each arm, respectively. There were no subjects analyzed at certain time points (that is, Number Analyzed = 0) because there was no data collected for respective arms at those time points.|||units on a scale||Standard Deviation|Mean
2647519|NCT01693068|Secondary|Percentage of Subjects With Overall Survival (OS) at 12 Months|OS was defined as the time (in months) from randomization to death due to any cause. Subjects without a death date were to be censored at the minimum of last known date alive, defined as the latest date available on the electronic case report form, and cut-off date. Percentage of Subjects with OS at 12 months were reported.|12 months|ITT analysis set included all subjects who were randomized to trial treatment.|||percentage of subjects||95% Confidence Interval|Number
2647520|NCT01693068|Secondary|Overall Survival (OS)|OS was defined as the time (in months) from randomization to death due to any cause. Subjects without a death date were to be censored at the minimum of last known date alive, defined as the latest date available on the electronic case report form, and cut-off date.|From date of randomization until date of death from any cause, assessed up to cut-off date (04-Jul-2015)|ITT analysis set included all subjects who were randomized to trial treatment.|||months||95% Confidence Interval|Median
2647521|NCT01693068|Secondary|Percentage of Subjects With Progression-free Survival (PFS) at 6 Months|PFS was defined as the duration (in weeks) from randomization until the first progressive disease (PD) observation as assessed by the Investigator according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1, or death due to any cause when death occurred within 12 weeks after the last tumor assessment, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions. Percentage of Subjects with PFS at 6 Months were reported.|6 months|ITT analysis set included all subjects who were randomized to trial treatment.|||percentage of subjects||95% Confidence Interval|Number
2647522|NCT01693068|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of subjects with CR, PR, or stable disease (SD) for greater than (>) 3 months assessed by investigator according to RECIST version 1.1. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than <10 mm. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters along with absence of new lesions and disease progression in non-target lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015)|ITT analysis set included all subjects who were randomized to trial treatment.|||percentage of subjects||95% Confidence Interval|Number
2647523|NCT01693068|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of subjects with complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria. CR: defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters along with absence of new lesions and disease progression in non-target lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015)|ITT analysis set included all subjects who were randomized to trial treatment.|||percentage of subjects||95% Confidence Interval|Number
2647524|NCT01693068|Primary|Progression Free Survival (PFS)|PFS was defined as the duration (in weeks) from randomization until the first progressive disease (PD) observation as assessed by the Investigator according to Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1, or death due to any cause when death occurred within 12 weeks after the last tumor assessment (otherwise censored), whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum since the treatment started (including baseline), or appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to cut-off date (04-Jul-2015)|ITT analysis set included all subjects who were randomized to trial treatment.|||weeks||95% Confidence Interval|Median
2647525|NCT01693029|Secondary|Incidence of Antibody Formation Against Epoetin|Number of patients with positive antidrug antibody (ADA) finding at any time during their treatment period. Count includes 2 patients (1 in each arm) that already had a positive ADA Baseline finding. ADA testing performed by by Radio-Immuno-Precipitation assay. No patient developed neutralizing antibodies.|52 weeks|All patients treated with study drug with a post-baseline antibody assessment|||Participants|||Count of Participants
2647556|NCT01692691|Secondary|Median Duration of Response|To determine the median duration of response for patients who received Dacarbazine and Carmustine|8 weeks|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
2647527|NCT01693029|Primary|Change in Mean Hb Level Between Baseline (Week -4 to Day1) and Evaluation Period (Week 21-28)|Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .|Week -4 to Day1 and Week 21-28|The intent-to-treat (ITT) population consists of all randomized patients who were exposed to treatment with study drug for at least four weeks and have at least one Hb value available at week 4 or later. Following the intent-to-treat principle, patients are analyzed according to the treatment they were assigned to at randomization.|||g/dL||Standard Deviation|Mean
2647528|NCT01693029|Primary|Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28)|Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .|Week -4 to Day1 and Week 21-28|The intent-to-treat (ITT) population consists of all randomized patients who were exposed to treatment with study drug for at least four weeks and have at least one Hb value available at week 4 or later. Following the intent-to-treat principle, patients are analyzed according to the treatment they were assigned to at randomization.|||g/dL||Standard Error|Least Squares Mean
2647529|NCT01692951|Primary|Compare Concentration of Fatty Acids and Their Metabolites|Biochemical analysis of serum sample was conducted by an investigator who was strictly blinded to cancer status and patient characteristics.|At the time of diagnosis, prior to the initiation of lung cancer treatment||||mg/mL||Inter-Quartile Range|Median
2647530|NCT01692938|Primary|Repeatability of Microperimetry Tests in Normal and With Pathology Participants Based on 3 Microperimetry Tests Taken for Each Participant for a Given Operator-device Combination.|A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. Test results were given in decibels as that is the standard measurement in microperimetry testing. For each subject, one eye was evaluated using 3 microperimetry tests with repositioning at the start of each test. Overall Repeatability SD and Repeatability SD Limit were calculated for the two groups: normal and with pathology.|1 Month||||decibels||Standard Deviation|Mean
2647531|NCT01692938|Primary|Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations|A precision study was conducted that used 3 devices (each with a different operator). Each device was used to measure 4 normal subjects and 4 subjects with relevant eye pathology, with a total of 24 subject eyes (12 normal, 12 with pathology) measured across all three devices. For each subject, one eye was evaluated using 3 tests with repositioning at the start of each test. Test results were given in decibels which is the unit used in microperimetry testing. Overall mean and standard deviation in decibels were calculated for the two groups: normal and with pathology.|1 Month||||decibels||Standard Deviation|Mean
2647532|NCT01692782|Secondary|Change From Baseline in the Wender-Reimher Adult Attention Deficit Disorder Scale (WRAADDS) as Measured at Weeks 1, 2, 3, 4.|The WRAADDS measured the severity of the target symptoms of adults with ADHD. It measured symptoms in 7 categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional overreactivity, disorganization, and impulsivity. The scale rated individual items from 0 to 2 (0 = not present, 1 = mild, 2 = clearly present) and summarized each of the 7 categories on a 0 to 4 scale (0 = none, 1 = mild, 2 = moderate, 3 = quite a bit, 4 = very much). The WRAADDS total score is defined as sum of all 28 item subscores (range 0 - 56).|Weeks 1, 2, 3, 4|Intent to treat|||units on a scale||Standard Error|Least Squares Mean
2647533|NCT01692782|Secondary|The Number of Responders at Weeks 1, 2, 3, 4. A Responder is Defined as a Subject With a ≥ 30% Improvement in ADHD Symptoms Compared With Baseline as Measured by the ADHD RS IV.||Weeks 1, 2, 3, 4|Intent to treat|||participants|||Number
2647534|NCT01692782|Secondary|Change From Baseline in the Inattentiveness and Hyperactivity Subscales of the ADHD RS IV at Weeks 1, 2, 3, 4|The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The even number items (2, 4, 6, 8, 10, 12, 14, 16, 18) assess hyperactive impulsive symptoms and the odd number items (1, 3, 5, 7, 9, 11, 13, 15, 17) assess inattentive symptoms. The ADHD inattentiveness subscale score is defined as sum of items (1, 3, 5, 7, 9, 11, 13, 15, 17) scores (range 0 - 27). The ADHD hyperactive impulsive subscale score is defined as sum of items (2, 4, 6, 8, 10, 12, 14, 16, 18) scores (range 0 - 27).|Weeks 1, 2, 3, 4|Intent to treat|||units on a scale||Standard Error|Least Squares Mean
2647535|NCT01692782|Secondary|Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI S) at Weeks 1, 2, 3, 4.|"The CGI-S modified asked the clinician one question: Considering your total clinical experience with adult ADHD, how mentally ill is the subject at this time?.The clinician's answer was rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = ng the most extremely ill subjects."|Weeks 1, 2, 3, 4|Intent to treat|||units on a scale||Standard Error|Least Squares Mean
2647536|NCT01692782|Secondary|Change From Baseline in ADHD Symptoms Measured With the ADHD RS IV at Weeks 1, 2, 3.|The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The ADHD rating scale total score is defined as sum of all 18 item scale scores (range 0 - 54).|Weeks 1, 2, 3|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
2647537|NCT01692782|Primary|Change From Baseline at Week 4 in ADHD Symptoms Measured With the ADHD Rating Scale Version IV With Adult Prompts (ADHD RS IV)|The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The ADHD rating scale total score is defined as sum of all 18 item scale scores.|4 Weeks|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
2647538|NCT01692756|Secondary|Synovial Matrix Metalloproteinase 9 (MMP-9) Concentration|Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-9 concentration using an immunoassay. Data will be presented as the change in MMP-9 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.|Up to seven days|Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.|||ng/mL||Standard Deviation|Mean
2647539|NCT01692756|Secondary|Synovial Matrix Metalloproteinase 3 (MMP-3) Concentration|Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-3 concentration using an immunoassay. Data will be presented as the change in MMP-3 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.|Up to seven days|Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.|||ng/mL||Standard Deviation|Mean
2647540|NCT01692756|Secondary|Synovial Matrix Metalloproteinase 1 (MMP-1) Concentration|Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure MMP-1 concentration using an immunoassay. Data will be presented as the change in MMP-1 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.|Up to seven days|Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.|||ng/mL||Standard Deviation|Mean
2647541|NCT01692756|Secondary|Synovial TNF-stimulated Gene 6 Protein (TSG-6) Concentration|Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure TSG-6 concentration using an immunoassay. Data will be presented as the change in TSG-6 concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.|Up to seven days|Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.|||ng/ml||Standard Deviation|Mean
2647542|NCT01692756|Secondary|Synovial Type I Collagen Cross-Linked N-Telopeptide (NTX-I) Concentration|Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure NTX-I concentration using an immunoassay. Data will be presented as the change in NTX-I concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.|Up to seven days|Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.|||µg/mL||Standard Deviation|Mean
2647543|NCT01692756|Secondary|Synovial Glycosaminoglycans (GAG) Concentration|Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure GAG concentration using an immunoassay. Data will be presented as the change in GAG concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.|Up to seven days|Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.|||μg/mL||Standard Deviation|Mean
2647544|NCT01692756|Secondary|Synovial Cartilage Oligomeric Matrix Protein (COMP) Concentration|Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure COMP concentration using an immunoassay. Data will be presented as the change in COMP concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.|Up to seven days|Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Group 1 n:1, Group 2 n:1) and 1 patient declined the pre-op assessment aspiration (Group 3 n:1) preventing analysis on these patients.|||μg/mL||Standard Deviation|Mean
2647545|NCT01692756|Secondary|Synovial C-terminal Peptide II (CTXII) Concentration|Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure CTXII concentration using an immunoassay. Data will be presented as the change in CTXII concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.|Up to seven days|Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Group 1 n:1, Group 2 n:1) and 1 patient declined the pre-op assessment aspiration (Group 3 n:1) preventing analysis on these patients.|||ng/mL||Standard Deviation|Mean
2647586|NCT01692197|Secondary|Disease-free Survival|Time from date of treatment start until the date of first objective documentation of disease-relapse.|Up to 5 years|Thirty seven patients are evaluable.|||months||Full Range|Median
2647546|NCT01692756|Secondary|Synovial Interleukin-1 Receptor Antagonist (IL-1ra) Concentration|Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1ra concentration using an immunoassay. Data will be presented as the change in IL-1ra concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.|Up to seven days|Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined the pre-op assessment aspiration (Gp 3 n:1) preventing analysis on these patients.|||pg/mL||Standard Deviation|Mean
2647547|NCT01692756|Secondary|Synovial Interleukin-1β (IL-1β) Concentration|Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1β concentration using an immunoassay. Data will be presented as the change in IL-1β concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.|Up to seven days|The values for two patients (Gp1 n:1, Gp 2 n:1) were below the limits of detection and were not included in the analysis. Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined 1 aspiration (Gp 3 n:1) preventing analysis on these patients.|||pg/mL||Standard Deviation|Mean
2647548|NCT01692756|Secondary|Synovial Interleukin-1α (IL-1α) Concentration|Participants will have a knee joint aspiration during their initial orthopedic consult and during pre-op assessment. Synovial fluid will be aspirated and spun at 3500RPM for 10 minutes then the supernatant will be pipetted and frozen. The supernatant will be used to measure IL-1α concentration using an immunoassay. Data will be presented as the change in IL-1α concentration from knee aspirate collected during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.|Up to seven days|The values for 3 patients (Gp1 n:1, Gp 2 n:1, Gp 3 n:1) were below the limits of detection and were not included in the analysis.Two other patients had dry knee aspirations, where the aspiration was performed but no fluid was collected, (Gp 1 n:1, Gp 2 n:1) and 1 patient declined 1 aspiration (Gp 3 n:1) preventing analysis on these patients.|||pg/mL||Standard Deviation|Mean
2647549|NCT01692756|Secondary|Efficacy of Kenalog to Alleviate Knee Pain|The efficacy of Kenalog with be determined using the Knee Injury and Osteoarthritis Outcome Score (KOOS) instrument. Participants will self-report knee pain and function through the KOOS questionnaire during the initial orthopedic consult and during the pre-op assessment prior to surgery, between 1 and 7 days later. The scale scores range from 100 (no symptoms) to zero (extreme symptoms).|Up to seven days||||units on a scale||Standard Deviation|Mean
2647550|NCT01692756|Primary|Participant Pain Assessment|Participants with be given a Visual Analog Scale (VAS) pain assessment questionnaire which scores the participant's perceived pain on a scale of 0-10 were zero is no pain and 10 is the worst pain imaginable. The scale will be administered during the initial orthopedic consult after injury and during the participant's pre-operative assessment, usually 1-7 days after the initial consult.|Up to seven days|A total of 4 patients (Group 1 n:1, Group 2 n:1, Group 4 n:2) overlooked completing the VAS. This was not realized until the patients had left the study visit preventing the investigator from collecting the information.|||units on a scale||Standard Deviation|Mean
2647551|NCT01692743|Secondary|Health Care Utilization|Total healthcare encounters 1 year post randomization (a specific scale was not used, simple counts of all encounters after randomization were carried out)|One year||||Encounters|||Number
2647552|NCT01692743|Primary|Inflammatory Bowel Disease Questionnaire|"Description: A quality of life (QoL) questionnaire for patients with inflammatory bowel diseases [1].~Format: 32 questions grouped into four dimensions: bowel, systemic, social, and emotional.~Scoring: Scores for each question range from 1 (poorest QoL) to 7 (best QoL). The overall range for the 32 item questionnaire is 32-224 with higher scores indicate better QoL. Scores >168 have been shown to correlate with clinical remission in patients with Crohn's disease and a change in score of 16-32 points is considered significant."|12 months|IBDQ Scores|||units on a scale||Standard Deviation|Mean
2647553|NCT01692743|Primary|Harvey Bradshaw Index|Disease activity measure for patients with Crohn's disease. The activity index is comprised of 5 items. General well being (0-4), abdominal pain (0-3), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam (0-3), and complications (1 point per item). The total score is the sum of the individual parameters with scores less than 5 consistent with clinical remission. The minimum score is 0 and there is no pre-specified maximum score as it depends on the number of liquids stools.|12 months|Crohn's disease population|||units on a scale||Standard Deviation|Mean
2647554|NCT01692730|Secondary|Number of Participants With Biochemically Verified Abstinence From Tobacco|Our primary outcome is biochemically-verified point-prevalence abstinence at 6 months. If participant self-reports no cigarettes (or other tobacco use) in the past 7 days, the past 30 days, or since a specific self-reported cessation date, biochemical verification will be conducted to measure salivary cotinine (a cut off of <10ng/ml confirms self-reported abstinence for at least the previous 7 days). Using Intent-to-Treat analysis, subjects who drop out or refuse biochemical verification will be considered smokers.|6 month follow-up|Not all participants provided saliva. Analysis was performed on a total of 109 participants.|||Participants|||Count of Participants
2647555|NCT01692730|Primary|Number of Participants Who Self-report Abstinence From Tobacco|Our primary outcome is self-reported abstinence at the six month evaluation point. Abstinence outcomes at this time point are defined in three ways: 1) as self-reported abstinence (no cigarettes or other tobacco use) in the past 7 days prior to this six month time point, 2) or as no use in the past 30 days prior to this six-month time point (the 30 day period is the more conservative measure), or 3) self-reported prolonged abstinence from the time of a specific self-reported cessation date.|6 month follow-up|The primary outcome time point was six months. These 1,000 participants completed the six month time point evaluation.|||Participants|||Count of Participants
2647557|NCT01692691|Secondary|Response Rate|To determine the response rate after being treated with Dacarbazine Carmustine|8 weeks|"Data not collected. The study has been terminated due to the PI no longer being employed at CTCA and not having rights to the trial information.After much effort, results were not able to be retained."||||||
2647559|NCT01692626|Primary|Percentage of Participants That do Not Experience Rash From Cetuximab Treatment on the Pimecrolimus Side of the Face.|To determine if 1% pimecrolimus prevents the rash associated with treatment with cetuximab, as assessed by lesion counts on clinical photographs after two weeks of treatment.|2 weeks||||Participants|||Count of Participants
2647560|NCT01692340|Primary|Time of Maximal Carotenoid Concentration|We will determine when the maximal carotenoid concentration is achieved in the plasma|0 to 48 hours||||hours||Standard Error|Mean
2647561|NCT01692340|Primary|Maximal Plasma Carotenoid Concentration|We will determine the average maximal plasma carotenoid concentration in healthy volunteers|0 to 48 hours||||micromol||Standard Error|Mean
2647562|NCT01692340|Secondary|Carotenoid Metabolites|Study the metabolites produced from the labeled carotenoid in healthy subjects|Up to 28 days|Due to funding issues, at present we have not analyzed these samples for carotenoid metabolites. We have frozen plasma and if funds become available we would consider anlayzing the samples for carotenoid metabolites.||||||
2647563|NCT01692340|Primary|Plasma Half Life of Labeled Carotenoid|We will study the half life of isotopically labeled carotenoids.|labelled lycopene: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose. Labelled phytoene: hourly for hours 0 - 15, then hours 17, 19 and 21 hours after dosing. Then, 1, 2, 3 4, 7, 10, 14, 17, 21 and 28 days post dose.||||days||Standard Error|Mean
2647564|NCT01692301|Secondary|Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (maPP)|Mean 24 hour ambulatory pulse pressure was calculated as the difference between the mean 24 hour systolic and diastolic ambulatory blood pressure in corresponding visits i.e. baseline, week 12 and week 52.|Baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).|||mmHg||Standard Error|Least Squares Mean
2647565|NCT01692301|Secondary|Change From Baseline in Mean 24-hour Diastolic Blood Pressure (maDBP)|An Ambulatory Blood Pressure Monitor (ABPM) measured a participant's blood pressure over a 24 hour period using an automated validated monitoring device at baseline, week 12 and at week 52 starting one day before each visit. The 24 hour maDBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24 hour period.|Baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).|||mmHg||Standard Error|Least Squares Mean
2647566|NCT01692301|Secondary|Change From Baseline in Mean 24-hour Systolic Blood Pressure (maSBP)|An Ambulatory Blood Pressure Monitor (ABPM) measured a participant's blood pressure over a 24 hour period using an automated validated monitoring device at baseline, week 12 and at week 52 starting one day before each visit. The 24 hour maSBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24 hour period.|Baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).|||mmHg||Standard Error|Least Squares Mean
2647567|NCT01692301|Secondary|Change From Baseline in Mean Arterial Pressure (MAP)|Mean arterial pressure (MAP) was calculated from mean sitting systolic BP (msSBP) and mean sitting diastolic BP (msDBP) as (2 * msDBP + msSBP)/3.|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).|||mmHg||Standard Error|Least Squares Mean
2647568|NCT01692301|Secondary|Change From Baseline in Mean Sitting Pulse Pressure (msPP)|Mean sitting pulse pressure for each patient and visit was calculated as the difference between the calculated values of mean sitting systolic blood pressure and mean sitting diastolic blood pressure.|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).|||mmHg||Standard Error|Least Squares Mean
2647569|NCT01692301|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|At the first study visit, the patient had his/her blood pressure (BP) measured in both arms; the arm in which the highest sitting SBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, DBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).|||mmHg||Standard Error|Least Squares Mean
2647570|NCT01692301|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|At the first study visit, the patient had his/her blood pressure (BP) measured in both arms; the arm in which the highest sitting SBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoints (week 12, week 52).|||mmHg||Standard Error|Least Squares Mean
2647571|NCT01692301|Secondary|Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 52 Weeks|"Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software.~At the first study visit, the arm with the highest systolic blood pressure (SBP) was used for all subsequent PWA. Brachial PWA measurements were performed on the same arm that the office blood pressures were taken. Two pulse waveform measurements, meeting all quality control criteria were captured at baseline and at week 12 visits."|baseline, 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoint (week 52). Four patients did not have a successful CASP assessment at Week 12 but passed quality check at Week 52, thus 4 more patients were included in the Week 52 Endpoint analysis.|||mmHg||Standard Error|Least Squares Mean
2647572|NCT01692301|Secondary|Change From Baseline in Mean Pulse Wave Velocity (PWV)|"Pulse wave velocity recordings were performed on patient while in a supine, face-up position.~Tonometry was performed on the carotid simultaneously with the cuff inflation over the femoral artery. Two pulse wave velocity measures, meeting all quality control criteria were captured at baseline, week 12 and week 52."|baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoint (week 12 , week 52).|||meter/second||Standard Error|Least Squares Mean
2647573|NCT01692301|Secondary|Change From Baseline in Mean Central Pulse (CPP) Pressure||Baseline, 12 weeks, and 52 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoint (week 12, week 52). Four patients did not have a successful CASP assessment at Week 12 but passed quality check at Week 52, thus 4 more patients were included in the Week 52 Endpoint analysis|||mmHg||Standard Error|Least Squares Mean
2647574|NCT01692301|Primary|Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 12 Weeks|"Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software.~At the first study visit, the arm with the highest systolic blood pressure (SBP) was used for all subsequent PWA. Brachial PWA measurements were performed on the same arm that the office blood pressures were taken. Two pulse waveform measurements, meeting all quality control criteria were captured at baseline and at week 12 visits."|baseline, 12 weeks|Full analysis set (FAS): All patients who were randomized. This endpoint included number of patients who had values at both baseline and endpoint (week 12).|||mmHg||Standard Error|Least Squares Mean
2647575|NCT01692275|Secondary|Back Pain Functional Scale (BPFS)|The BPFS is a 12-question functional status survey designed for use as an individual patient decision-making tool. Each of the 12 questions is answered using a 5-point Likert-type scale and therefore scores for this scale will range from 0-60 (higher scores indicate better function). In recent studies, the BPFS is improved sensitivity to change than the RMDQ. This scale will be administered at baseline and all endpoint visits.|Baseline and all endpoint visits (week 2, week 4, week 6, week 12)||||units on a scale||95% Confidence Interval|Mean
2647576|NCT01692275|Secondary|Patient Expectation|"Previous work has shown that patient expectation regarding benefit of care can be a significant non-specific effect.~The score indicates participant's expectation of helpfulness of treatment for LBP, measured on a scale of 0 (not helpful at all) to 10 (extremely helpful)."|Baseline only||||units on a scale||Standard Deviation|Mean
2647577|NCT01692275|Secondary|Patient Satisfaction|A one item patient satisfaction questionnaire. Satisfaction is measured as means on a numerical rating scale, 0 [not at all satisfied] to 10 [extremely satisfied].|Week 6||||units on a scale||95% Confidence Interval|Mean
2647578|NCT01692275|Secondary|Global Improvement Scale|This is a modification of the visual analog scale (VAS) developed to assess degree of improvement over a specified period of time. Global low back pain (LBP) improvement was assessed by asking participants to rate their perceived LBP improvement since baseline on a 7-point scale: 0 = completely gone, 1 = much better, 2 = moderately better, 3 = a little better, 4 = about the same, 5 = a little worse, 6 = much worse.|Week 6||||Participants|||Count of Participants
2647579|NCT01692275|Secondary|Healthcare Utilization & Medication Use|Based on the pilot study, volunteers will most likely have been seen by other healthcare providers and prescribed pain medication by a primary care provider prior to being enrolled in the study, this questionnaire will ensure that we collect all healthcare and medication use.|week 6, week 12||||Participants|||Count of Participants
2647580|NCT01692275|Secondary|Numerical Pain Rating Scale (NRS) for Past 24 Hours|Volunteers will be asked to rate their level of pain on that day on an ordinal 11-box scale (0=no LBP; 10=worst LBP possible) at baseline and at all of the follow-up assessments. The NRS has excellent metric properties, is easy to administer and score, and has received much use in LBP research. Pain data will be collected at baseline and at all endpoint visits. The question will capture information pertaining to pain over the last 24 hours.|Baseline, week 6, week 12||||units on a scale||95% Confidence Interval|Mean
2647581|NCT01692275|Secondary|Bothersomeness of Symptoms|"The bothersomeness of symptoms commonly associated with LBP will be measured using an existing measure from the LBP literature. Bothersomeness questions are practical and have demonstrated good internal consistency, construct validity, and responsiveness to change with time in patients with LBP and sciatica.~Possible score ranges from 1 (not at all bothersome) to 5 (extremely bothersome)."|Baseline, week 6, week 12||||units on a scale||95% Confidence Interval|Mean
2647582|NCT01692275|Primary|Roland Morris Disability Questionnaire (RMDQ)|We will use a volunteer self-report modified 24-item version of the RMDQ to assess LBP-related disability. The RMDQ may be the most common and respected LBP assessment instrument in LBP outcomes research. It is a one page questionnaire related to LBP disability with documented reliability and validity. It can discriminate between different forms of treatment for back pain, and it is sensitive to clinical change. The RMDQ has been chosen for a number of clinical trials of LBP treatments for its excellent metric properties, ease of use, patient acceptance, and high face validity. This questionnaire will be administered at baseline and at all endpoints. Higher score indicates higher disability. Scale: 0 (no disability) to 24 (maximum disability).|Baseline, week 6, week 12||||units on a scale||95% Confidence Interval|Mean
2647583|NCT01692275|Primary|Numerical Rating Scale (NRS) for Prior Week|Volunteers will be asked to rate their average level of low back pain (LBP) during the prior week on an ordinal 11-box scale (0=no LBP; 10=worst LBP possible) at baseline and at all of the follow-up assessments. The NRS has excellent metric properties, is easy to administer and score, and has received much use in LBP research. Pain data will be collected at baseline and at all endpoint visits.|Baseline, week 6, week 12||||units on a scale||95% Confidence Interval|Mean
2647584|NCT01692197|Secondary|Overall Survival|Time from date of treatment start until date of death due to any cause or last follow-up.|Up to 5 years|Thirty seven patients are evaluable.|||months||Full Range|Median
2647585|NCT01692197|Secondary|Duration of Response|Response date to loss of response or last follow up.|Up to 5 years|Thirty seven patients are evaluable.|||months||Full Range|Median
2647587|NCT01692197|Primary|Overall Response|Efficacy measured by overall response - complete response plus complete response with incomplete platelet recovery, plus partial response (Complete remission (CR) + Complete remission without platelet recovery (CRp) + Partial Remission (PR)+ marrow clearance of blast) during cycle 1.|2 cycles (60 days)|Thirty seven patients are evaluable.|||Participants|||Count of Participants
2647588|NCT01691950|Secondary|Participant Length of Hospital Stay|These measurements refer to the participants healthcare journey (which are not affected by the research project). Hospital stay refers to the time around their lower limb trauma and any further admissions.|Up to length of study (1-2 years)|||||||
2647589|NCT01691950|Primary|Functional Outcome (Consisting of Questionnaire Score, Hamlyn Mobility Score (HMS) Gait/Activities of Daily Living Parameters)|The Hamlyn Mobility Score is a measure of functional mobility as measured by a wearable sensors during simple physical activities. The score range is from 0 - 60, with 60 being the best score possible and represents normal physical function of a healthy adult.|3 months post-reconstruction||||units on a scale||Standard Deviation|Mean
2647590|NCT01691898|Secondary|Percentage of Participants With PD as Determined by Modified Response and Progression Criteria for NHL or Death Due to Any Cause: Obinutuzumab Containing Cohorts (Cohorts E + H and E + G)|Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.|Baseline up to PD or death due to any cause, whichever occurs first (up to approximately 5.5 years)|Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population.|||percentage of participants|||Number
2647591|NCT01691898|Secondary|Progression-free Survival (PFS) as Determined by Modified Response and Progression Criteria for NHL: Obinutuzumab Containing Cohorts (Cohorts E + H and E + G)|Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node. PFS was defined as the time from the date of randomization to the date of PD or death from any cause, whichever occurred first. In absence of PD or death, PFS was censored at the date of the last tumor assessment. Participants with no post-baseline tumor assessment were censored on the date of randomization or date of enrollment. The median PFS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years)|Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population.|||months||95% Confidence Interval|Median
2647592|NCT01691898|Secondary|Percentage of Participants Who Died Due to Any Cause: Obinutuzumab Containing Cohorts (Cohorts E + H and E + G)|Percentage of participants who died due to any cause was reported.|Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)|Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population.|||percentage of participants|||Number
2647593|NCT01691898|Secondary|Overall Survival (OS): Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)|OS was defined as the time from the date of randomization or enrollment to the date of death from any cause. The median OS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)|Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||Months||95% Confidence Interval|Median
2647594|NCT01691898|Secondary|Cmax of Obinutuzumab: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)|Cmax of obinutuzumab was estimated from serum concentration data using non-compartmental analysis.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2647595|NCT01691898|Secondary|Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab|Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations.|||ng/mL||Standard Deviation|Mean
2647596|NCT01691898|Secondary|Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab|Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2647652|NCT01691859|Secondary|Number of Participants With Hematology Data of Potential Clinical Concern|Hematology parameters with laboratory ranges defining values of potential clinical concern included hemoglobin, hematocrit, platelet count, white blood cell count. Number of participants with clinical hematology abnormalities of potential clinical concern anytime post baseline are presented, which only included participants with low hemoglobin values. Only those participants who provided lab data post-baseline were analyzed.|Baseline (Week 0) to Week 240|AT Population.|||Participants|||Number
2673277|NCT01462877|Secondary|Change in Serum Low-density Lipoprotein Cholesterol|Blood tests|Baseline up to 8 weeks after intervention|Full analysis set|||percentage of LDL-C change||Standard Deviation|Mean
2647597|NCT01691898|Secondary|Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab|Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2647598|NCT01691898|Secondary|AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab|AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations.|||day*ng/mL||Standard Deviation|Mean
2647599|NCT01691898|Secondary|AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab|AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||day*ng/mL||Standard Deviation|Mean
2647600|NCT01691898|Secondary|AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Obinutuzumab|AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with obinutuzumab (Cohort E+H and E+G) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||day*mcg/mL||Standard Deviation|Mean
2647601|NCT01691898|Secondary|Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab|Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations.|||ng/mL||Standard Deviation|Mean
2647602|NCT01691898|Secondary|Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab|Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2647603|NCT01691898|Secondary|Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab|Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2647604|NCT01691898|Secondary|AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab|AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations.|||day*ng/mL||Standard Deviation|Mean
2647605|NCT01691898|Secondary|AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab|AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||day*ng/mL||Standard Deviation|Mean
2673278|NCT01462877|Secondary|Change in Serum Total Cholesterol|Blood tests|Baseline and up to 8 weeks after intervention|Full analysis set|||percentage of TC change||Standard Deviation|Mean
2647606|NCT01691898|Secondary|AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 1.8 mg/kg Given in Combination With Rituximab|AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 1.8 mg/kg in combination with rituximab (Cohort C) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||day*mcg/mL||Standard Deviation|Mean
2647607|NCT01691898|Secondary|Cmax of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|Cmax of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations.|||ng/mL||Standard Deviation|Mean
2647608|NCT01691898|Secondary|Cmax of acMMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|Cmax of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2647609|NCT01691898|Secondary|Cmax of Total Antibody for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|Cmax of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2647610|NCT01691898|Secondary|AUClast of Unconjugated MMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|AUClast of Unconjugated MMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations.|||day*ng/mL||Standard Deviation|Mean
2647611|NCT01691898|Secondary|AUCinf of acMMAE for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|AUCinf of acMMAE for polatuzumab vedotin was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||day*ng/mL||Standard Deviation|Mean
2647612|NCT01691898|Secondary|AUCinf of Total Antibody for Polatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|AUCinf of total antibody for polatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received polatuzumab vedotin at dose level 2.4 mg/kg in combination with rituximab (Arm B) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||day*mcg/mL||Standard Deviation|Mean
2647613|NCT01691898|Secondary|Cmax of Unconjugated MMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|Cmax of unconjugated MMAE was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations.|||ng/mL||Standard Deviation|Mean
2647614|NCT01691898|Secondary|Cmax of acMMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|Cmax of acMMAE for pinatuzumab was estimated from plasma concentration data using non-compartmental analysis. acMMAE is the total concentration of MMAE that was conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2647846|NCT01690130|Secondary|the Change From Baseline in Resting Motor Threshold|Resting Motor Threshold (RMT) on a scale from 0-100, with 100 being most power given to enact a motor response|20 minutes before (baseline) and 20 minutes after rTMS experiment||||units on a scale||Standard Error|Mean
2647615|NCT01691898|Secondary|Cmax of Total Antibody for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|Cmax of total antibody for pinatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with MMAE-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2647616|NCT01691898|Secondary|Area Under the Concentration-Time Curve From Time Zero To Last Measurable Concentration (AUClast) of Unconjugated MMAE for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|AUClast of unconjugated MMAE was estimated from plasma concentration data using non-compartmental analysis. Unconjugated MMAE is the total concentration of MMAE that was not conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations.|||day*ng/mL||Standard Deviation|Mean
2647617|NCT01691898|Secondary|AUCinf of Antibody Conjugated Monomethyl Auristatin E (acMMAE) for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|AUCinf of acMMAE for pinatuzumab was estimated from plasma concentration data using non-compartmental analysis. Antibody conjugated MMAE is the total concentration of MMAE that was conjugated to the antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||day*nanogram (ng)/mL||Standard Deviation|Mean
2647618|NCT01691898|Secondary|AUCinf of Total Antibody for Pinatuzumab Vedotin at Dose Level 2.4 mg/kg Given in Combination With Rituximab|AUCinf of total antibody for pinatuzumab vedotin was estimated from serum concentration data using non-compartmental analysis. Total antibody is defined as antibody with Monomethyl Auristatin E (MMAE)-to-antibody ratio equal or greater than zero, including fully conjugated, partially unconjugated, and fully unconjugated antibody.|Pre-infusion (Hour 0) & 30 minutes Post-infusion (infusion length=30-90 minutes) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 Days)|Analysis was performed on all participants who received pinatuzumab vedotin (Arm A) with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||day*mcg/mL||Standard Deviation|Mean
2647619|NCT01691898|Secondary|Volume of Distribution at Steady State (Vss) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)|"Vss for rituximab was estimated from serum concentration data using non-compartmental analysis.~Time Frame: Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months after treatment completion visit (approximately up to 1.5 years, Cycle length= 21 days)"|Day 1 up to 1.5 years (detailed timeframe is provided in the Outcome Measure Description)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||mL/m^2||Standard Deviation|Mean
2647620|NCT01691898|Secondary|Half-Life (t1/2) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)|"t1/2 for rituximab was estimated from serum concentration data using non-compartmental analysis.~Time Frame: Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1-4 and every 4th Cycle thereafter (approximately up to 1.5 years); Day 8, Day 15 of Cycle 1 and 3; 30 Days after last infusion; 2, 4, & 6 months after treatment completion visit (approximately up to 1.5 years, Cycle length= 21 days)."|Day 1 up to 1.5 years (detailed timeframe is provided in the Outcome Measure Description)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||days||Standard Deviation|Mean
2647621|NCT01691898|Secondary|Systemic Clearance (CL) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)|CL for rituximab was estimated from serum concentration data using non-compartmental analysis.|Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||mL/day/meter-square (m^2)||Standard Deviation|Mean
2647622|NCT01691898|Secondary|Maximum Observed Concentration (Cmax) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)|Cmax for rituximab was estimated from serum concentration data using non-compartmental analysis.|Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable PK concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||mcg/mL||Standard Deviation|Mean
2647623|NCT01691898|Secondary|Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Rituximab: Rituximab Containing Regimens (Arms A and B, Cohort C)|AUCinf for rituximab was estimated from serum concentration data using non-compartmental analysis.|Pre-infusion (Hour 0) & 30 minutes post-infusion (infusion length= 2-6 hours) on Day 1 of Cycle 1; Day 8, Day 15 of Cycle 1 (Cycle length= 21 days)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on all participants with measurable pharmacokinetic (PK) concentrations. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||day*micrograms (mcg)/milliliter (mL)||Standard Deviation|Mean
2648259|NCT01686750|Secondary|Proportion of HIV-infected Participants Aware of Status|Proportion of HIV-positive participants that were aware of their status at the time of the visit|2 years|Participants who tested HIV-positive at the survey visit|||percentage of participants|clusters|Full Range|Mean
2647624|NCT01691898|Secondary|Percentage of Participants With Best OR Based on PET/CT or CT Assessment as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)|Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT or CT scan. Best OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.|Baseline up to disease progression or death, whichever occurred first (up to approximately 5.5 years)|Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
2647625|NCT01691898|Secondary|Percentage of Participants With OR at EOT Based on CT Assessment Alone as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)|Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. OR was defined as a response of CR or PR. CR was defined as reduction of LDi of target nodes/nodal masses to </=1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. PR was defined as >/=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen by at least >50% beyond normal; and no new lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)|Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
2647626|NCT01691898|Secondary|Percentage of Participants With OR at EOT Based on CT Assessment Alone as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)|Tumor response assessment was performed by an IRC according to modified Lugano classification using CT scan. OR was defined as a response of CR or PR. CR was defined as reduction of LDi of target nodes/nodal masses to </=1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. PR was defined as >/=50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absence/reduction/no increase in size of non-measured lesions; reduction in length of spleen by at least >50% beyond normal; and no new lesions. 90% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)|Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
2647627|NCT01691898|Secondary|Percentage of Participants With CR at EOT Based on CT Assessment Alone as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)|Tumor response assessment was performed by investigator according to modified Lugano classification using CT scan. CR was defined as reduction of LDi of target nodes/nodal masses to </=1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. 90% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)|Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
2647628|NCT01691898|Secondary|Percentage of Participants With CR at EOT Based on CT Assessment Alone as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G)|Tumor response assessment was performed by an IRC according to modified Lugano classification using CT scan. CR was defined as reduction of longest transverse diameter (LDi) of target nodes/nodal masses to less than or equal to (</=) 1.5 cm, no extralymphatic sites of disease, absence of non-measured lesions and new lesions, reduction of enlarged organs to normal, and normal/IHC-negative bone marrow morphology. 90% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)|Obinutuzumab-Containing Cohorts (Cohorts E + H and E + G): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
2647636|NCT01691898|Secondary|Number of Participants With ADA to Obinutuzumab|"Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against obinutuzumab at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have Treatment-induced ADAs or Treatment-enhanced ADA during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result."|Baseline, post-baseline (up to approximately 5.5 years)|Analysis was performed on safety-evaluable population (only participants who received obinutuzumab). Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time points.|||participants|||Number
2647629|NCT01691898|Secondary|Percentage of Participants With OR at EOT Based on PET/CT Assessment as Determined by the Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)|Tumor response assessment was performed by investigator according to modified Lugano classification using PET/CT scan. OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately >liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)|Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
2647630|NCT01691898|Secondary|Percentage of Participants With OR at EOT Based on PET/CT Assessment as Determined by IRC Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)|Tumor response assessment was performed by an IRC according to modified Lugano classification using PET/CT scan. OR was defined as a response of CR or PR. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. PR was defined as a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites; no new lesions; and reduced residual uptake in bone marrow compared with baseline. 90% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)|Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
2647631|NCT01691898|Secondary|Percentage of Participants With CR at EOT Based on PET/CT Assessment as Determined by Investigator Per Lugano 2014 Response Criteria: Obinutuzumab-Containing Cohorts (Cohorts E, G, and H)|Tumor response assessment was performed by the investigator according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake </=mediastinum), or 3 (uptake <mediastinum but </=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites; no new lesions; no evidence of FDG-avid disease in bone marrow; and normal/IHC-negative bone marrow morphology. 90% CI for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)|Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
2647632|NCT01691898|Secondary|Overall Survival (OS): Rituximab Containing Regimens (Arms A and B, Cohort C)|OS was defined as the time from the date of randomization or enrollment to the date of death from any cause. The median OS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.|||months||95% Confidence Interval|Median
2647633|NCT01691898|Secondary|Percentage of Participants Who Died Due to Any Cause: Rituximab Containing Regimens (Arms A and B, Cohort C)|Percentage of participants who died due to any cause was reported.|Baseline up to death due to any cause (from baseline up to study completion date, up to approximately 5.5 years)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.|||percentage of participants|||Number
2647634|NCT01691898|Secondary|Progression-free Survival (PFS) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C)|Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node. PFS was defined as the time from the date of randomization to the date of PD or death from any cause, whichever occurred first. In absence of PD or death, PFS was censored at the date of the last tumor assessment. Participants with no post-baseline tumor assessment were censored on the date of randomization or date of enrollment. The median PFS was estimated using Kaplan-Meier estimates and the 95% CI for median was computed using the method of Brookmeyer and Crowley.|Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.|||months||95% Confidence Interval|Median
2647635|NCT01691898|Secondary|Percentage of Participants With PD as Determined by Modified Response and Progression Criteria for NHL or Death Due to Any Cause: Rituximab Containing Regimens (Arms A and B, Cohort C)|Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments >/=4 weeks after initial documentation. PD was defined as appearance of any new lesion more than 1.5 cm in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.|Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 5.5 years)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population.|||percentage of participants|||Number
2648260|NCT01686750|Primary|Proportion Reporting HIV Testing in the Prior 12 Months|Self-reported HIV testing in the prior 12 months among all survey participants, excluding those who reported being diagnosed with HIV more than 12 months previously.|2 years||||percentage of participants|clusters|Full Range|Mean
2647637|NCT01691898|Secondary|Number of Participants With ADA to Polatuzumab Vedotin|"Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against polatuzumab vedotin at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have Treatment-induced ADAs or Treatment-enhanced ADA during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result."|Baseline, post-baseline (up to approximately 5.5 years)|Analysis was performed on safety-evaluable population (only participants who received polatuzumab vedotin). Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time points.|||participants|||Number
2647638|NCT01691898|Secondary|Number of Participants With Anti-Drug Antibodies (ADA) to Pinatuzumab Vedotin|"Participants provided blood samples for evaluation of ADA. The number of participants with positive results for ADA against pinatuzumab vedotin at Baseline and at any of the post-baseline assessment time-points (overall 1.5 years) was reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have Treatment-induced ADAs or Treatment-enhanced ADA during the study period. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result."|Baseline, post-baseline (up to approximately 5.5 years)|Analysis was performed on safety-evaluable population (only participants who received pinatuzumab vedotin). Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable at specified time points.|||participants|||Number
2647639|NCT01691898|Primary|Percentage of Participants With CR at End of Treatment (EOT) Based on Positron Emission Tomographic/Computed Tomography (PET/CT) Assessment Determined by Independent Review Committee (IRC) Per Lugano 2014 Response Criteria: Cohorts E, G, and H|Tumor response assessment was performed by an IRC according to modified Lugano classification using PET/CT scan. CR was defined as a score of 1 (no uptake above background), 2 (uptake less than or equal to [</=] mediastinum), or 3 (uptake less than [<] mediastinum but </=liver) with or without a residual mass on PET 5-point scale (5-PS), for lymph nodes and extralymphatic sites; no new lesions; no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow; and normal/immunohistochemistry (IHC)-negative bone marrow morphology. 90% confidence interval (CI) for percentage of responders was calculated using Clopper-Pearson method.|6-8 weeks after Cycle 8 Day 1 (cycle length = 21 Days) or last study treatment (maximum up to 27-29 weeks)|Obinutuzumab-Containing Cohorts (Cohorts E, G, and H): Analysis was performed on efficacy-evaluable population. Here, 'Overall Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure.|||percentage of participants||90% Confidence Interval|Number
2647640|NCT01691898|Primary|Duration of Objective Response (DOR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C)|Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014). DOR was defined as the time from the initial documentation of a CR or PR to the time of PD or death. CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as >/=50% decrease in SPD of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >/=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis, at least a 50% increase from nadir in the SPD or longest diameter of any previous lesion or node.|First occurrence of objective response up to PD/relapse or death due to any cause, whichever occurred first (up to approximately 3.5 years)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population participants who achieved objective response.|||months||Full Range|Median
2647641|NCT01691898|Primary|Percentage of Participants With a Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) as Determined by Modified Response and Progression Criteria for NHL: Rituximab Containing Regimens (Arms A and B, Cohort C)|Tumor response was evaluated according to modified response and progression criteria for NHL published by Cheson et al (2007 and 2014) and confirmed by repeat assessments greater than or equal to (>/=) 4 weeks after initial documentation. CR was defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. PR was defined as >/=50 percent (%) decrease in sum of the products of greatest diameters (SPD) of up to six of the largest dominant lymph nodes, no increase in size of other nodes, liver, or spleen volume, a >/=50% decrease in SPD of hepatic and splenic nodules, absence of other organ involvement, and no new sites of disease. Participants with insufficient data to determine response were classified as non-responders.|Baseline up to 12 months after the last dose of study treatment (up to approximately 3.5 years)|Rituximab Containing Regimens (Arms A and B, Cohort C): Analysis was performed on efficacy-evaluable population, which included all participants with baseline measurable disease and at least one post-baseline tumor assessment after study treatment.|||percentage of participants||90% Confidence Interval|Number
2647651|NCT01691859|Secondary|Mean Change From Baseline in Vital Signs-Sitting Diastolic Blood Pressure and Sitting Systolic Blood Pressure|Vital signs included sitting pulse rate and sitting blood pressure (diastolic and systolic). Measurements were done pre injection with the participant sitting, having rested in this position for at least 5 minutes before each reading. Baseline was Week 0. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|Baseline (Week 0) to Week 240|AT Population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2648362|NCT01685684|Secondary|Percent Reduction in Pain Intensity for Responders|Includes the cumulative distribution of subjects with an improvement in pain intensity, as measured on an 11-point PI-NRS scale, and the proportion of responders with at least 30% and at least 50% reduction in pain intensity.|Screening Baseline through Week 12||||participants|||Number
2647642|NCT01691885|Primary|Mean Change From Baseline in Right Ventricular End Diastolic Volume Index (RVEDVI) at the End of the Overall Treatment Period|RVEDVI is a measure of the volume of blood in the right ventricle at the end of diastole, normalized over body surface area and was measured using Cardiac Magnetic Resonance (CMR) imaging. RVEDVI is calculated as the right ventricular end diastolic volume (RDEDV) divided by the body surface area (BSA). The change from Baseline in RVEDVI was analyzed using a mixed model analysis with period, treatment group, and Baseline RVEDVI fitted as fixed effects and participants fitted as a random effect. The Baseline is defined as the assessment performed pre-dose at Day 1 of Treatment Period 1. The change from Baseline is calculated as the RVEDVI value at the end of each treatment period minus the Baseline value. The Per Protocol (PP) Population was comprised of all participants in the modified intent-to-treat (mITT) Population not identified as having deviations considered to impact the primary efficacy analysis.|Baseline and end of Treatment Period (7 days)|PP Population. Only those participants available at the specified time points were analyzed|||Milliliter per meter square (mL/m^2)||Standard Error|Least Squares Mean
2647643|NCT01691859|Secondary|Number of Participants Who Withdrew Due to AE|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Number of participants who withdrew due to AE are presented.|Baseline (Week 0) to Week 240|AT Population.|||Participants|||Number
2647644|NCT01691859|Secondary|Number of Participants Requiring Hospitalizations Due to Adverse Events Including Asthma Exacerbations|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Number of participants requiring hospitalization due to an on-treatment serious adverse event including asthma exacerbations are presented. On-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose of mepolizumab + 28 days.|Baseline (Week 0) to Week 240|AT Population.|||Participants|||Number
2647645|NCT01691859|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy|Lack of efficacy referred to failure of expected pharmacological action of Mepolizumab. Number of participants who withdrew due to lack of efficacy are presented.|Baseline (Week 0) to Week 240|AT Population.|||Participants|||Number
2647646|NCT01691859|Secondary|Number of Participants With Positive Anti-mepolizumab Binding Antibodies (ADA) and Neutralizing Antibodies (NAb)|Immunogenicity testing included two types of assays: a binding antibody assay (anti-drug antibody; ADA) and a neutralizing antibody (NAb) assay for participants who were tested positive in the ADA assay. Blood samples were collected for the determination of anti-mepolizumab antibodies, just prior to administration of mepolizumab. Samples that test positive for anti-mepolizumab antibodies were further tested for the presence of neutralizing antibody. Number of participants with positive highest value post-Baseline have been presented. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|Baseline (Week 0) to Week 240|AT Population.|||Participants|||Number
2647647|NCT01691859|Secondary|Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is forced expiratory volume in the first second. The volume of air that can be forced out in one second after taking a deep breath, an important measure of pulmonary function. Forced expiratory volume (FEV) measures how much air a person can exhale during a forced breath. FEV1 was measured by clinic spirometry. Baseline was Week 0. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|Baseline (Week 0) to Week 240|AT Population.|||Milliliters (mL)||Standard Deviation|Mean
2647648|NCT01691859|Secondary|Mean Change From Baseline in Asthma Control Questionnaire (ACQ) Score|The ACQ-5 is a five-item questionnaire, which was developed as a measure of participant' asthma control that was completed by the participant. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze). The ACQ consists of 5 questions that are scored on a 7 point scale from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ score was derived as mean of five questions: ACQ score = Question 1 (Q1)+Q2+Q3+Q4+Q5 divided by 5 where Q1, Q2,... Q5 are the scores of Q1, Q2, ..., Q5, respectively. The total score ranged from zero (no impairment/limitation) which indicated best condition to six (total impairment/ limitation) which indicated worst asthma. Baseline was Week 0. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|Baseline (Week 0) to Week 240|AT Population.|||Scores on a Scale||Standard Deviation|Mean
2647649|NCT01691859|Secondary|Annualized Rate of On-treatment Exacerbations|Exacerbations were defined as worsening of asthma which required use of systemic corticosteroids and/or hospitalization and/or Emergency Department visits. Data is presented as mean which is exacerbation rate/year. Exacerbation data are performed using a negative binomial model with covariates of region, annualized rate of exacerbations in the interval between MEA112997 and MEA115666 (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.|Baseline (Week 0) to Week 240|AT Population.|||Exacerbations per year||95% Confidence Interval|Mean
2647650|NCT01691859|Secondary|Mean Change From Baseline in Vital Signs-Sitting Pulse Rate|Vital signs included sitting pulse rate and blood pressure (diastolic and systolic). Measurements were done pre injection with the participant sitting, having rested in this position for at least 5 minutes before each reading. Baseline was Week 0. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|Baseline (Week 0) to Week 240|AT Population.|||Beats per minute||Standard Deviation|Mean
2647653|NCT01691859|Secondary|Number of Participants With Clinical Chemistry Data of Potential Clinical Concern|Clinical chemistry analytes with laboratory ranges defining values of potential clinical concern included sodium, potassium, calcium, phosphate, serum glucose and alanine aminotransferase. Number of participants with clinical chemistry abnormalities of potential clinical concern anytime post baseline are presented. Only those participants who provided lab data post-baseline were analyzed represented by n=X in the category titles.|Baseline (Week 0) to Week 240|AT Population.|||Participants|||Number
2647654|NCT01691859|Secondary|Number of Participants With a Maximum Change From Baseline for QTc(F) and QTc(B)|Twelve-lead ECGs were performed at Screening and every 24 weeks during the treatment period. ECG measurements were made after the participant had rested in the supine position for 5 minutes. Collection shortly after a meal or during sleep was avoided as QT prolongation can occur at these times. Baseline was the last available ECG prior to mepolizumab dosing. Change from Baseline was post-Baseline values minus Baseline values. Number of participants with a maximum change from Baseline for QTc(F) and QTc(B) at any time post Baseline are presented. Only those participants who provided ECG data at baseline and post-baseline were analyzed.|Baseline (Week 0) to Week 240|AT Population.|||Participants|||Number
2647655|NCT01691859|Secondary|Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTc[F])|Twelve-lead ECGs were performed at Screening and every 24 weeks during the treatment period. ECG measurements were made after the participant had rested in the supine position for 5 minutes. Collection shortly after a meal or during sleep was avoided as QT prolongation can occur at these times. Baseline was the last available ECG prior to mepolizumab dosing. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|Baseline (Week 0) to Week 240|AT Population.|||Milliseconds||Standard Deviation|Mean
2647656|NCT01691859|Secondary|Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTc[B])|Twelve-lead ECGs were performed at Screening and every 24 weeks during the treatment period. ECG measurements were made after the participant had rested in the supine position for 5 minutes. Collection shortly after a meal or during sleep was avoided as QT prolongation can occur at these times. Baseline was the last available ECG prior to mepolizumab dosing. Change from Baseline was post-Baseline values minus Baseline values. Only those participants available at the specified time points were analyzed represented by n=X in the category titles.|Baseline (Week 0) to Week 240|AT Population.|||Milliseconds||Standard Deviation|Mean
2647657|NCT01691859|Secondary|Number of Participants Who Experienced On-treatment Systemic (i.e., Allergic/Immunoglobulin E [IgE]-Mediated and Non-allergic) and On-treatment Local Site Reactions|Systemic and local site reactions following mepolizumab dosing as identified by the investigator and the number of participants who experienced systemic and/or local site reactions are presented. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose of mepolizumab + 28 days.|Baseline (Week 0) to Week 240|AT Population.|||Participants|||Number
2647658|NCT01691859|Primary|Number of Participants Who Experienced On-treatment Adverse Events (AE) and On-treatment Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with use of a medicinal product (MP), whether or not considered related to MP. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with use of MP. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. As Treated (AT) Population consisted of participants who received at least one dose of open label mepolizumab. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose of mepolizumab + 28 days.|Baseline (Week 0) to Week 240|AT Population.|||Participants|||Number
2647659|NCT01691833|Secondary|Lost to Follow-up|Lost to follow-up if they did not meet the criteria for an outcome by 15 months after injury or surgery; were without another scheduled follow-up appointment, could not be contacted or refused to return for evaluation or send alternate records when contacted.|15 months||||Participants|||Count of Participants
2647660|NCT01691833|Secondary|Deep Infection|A deep infection was defined as an unexpected return to theatre for irrigation and debridement with positive cultures from below the fascia.|15 months||||Participants|||Count of Participants
2647661|NCT01691833|Secondary|Fixation Failure|Early failure of fixation was defined as the need to revise the fixation within three months.|three months||||Participants|||Count of Participants
2647662|NCT01691833|Primary|Fracture Non-union|If a patient did not meet the criteria for union and had at least nine months of follow-up or underwent re-operation for a diagnosis of a nonunion, they were deemed to have a nonunion.|9 months||||Participants|||Count of Participants
2647663|NCT01691833|Primary|Fracture Union|Fracture Union is define as either clinical or radiological union. Clinical union defined as the absence of pain at the fracture site with the ability to bear full weight on the extremity without pain for activities of daily living (ambulation, lifting, carrying). Radiological union was determined by two blinded, independent review-ers and defined as the presence of bridging callus across at least three of four cortices or two of four cortices with a stable implant. When discrepancies between clinical and radiological union arose, the clinical assessment of union was preferred. Discrepancies in radiological outcomes were re-examined and a consensus view was obtained between reviewers if needed, to determine the outcome.If a patient did not meet the criteria for union and had at least nine months of follow•up or underwent re-operation for a diagnosis of a nonunion, they were deemed to have a nonunion.|up to 9 months post-surgery||||Participants|||Count of Participants
2647672|NCT01691820|Primary|Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine|This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR), for a cut-off value > 0 copies/mL.|At Month 12|This analysis was performed on the seropositive subjects with GMC > the specified threshold, at Month 12, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||DNA copies/mL||95% Confidence Interval|Geometric Mean
2647664|NCT01691820|Secondary|Anti-CMV Tegument Protein IgG Antibody Concentration in Serum|This outcome is part of the assessment of occurrence of CMV primary infections determined in all seronegative subjects, on samples collected during the 4-month site visits until study conclusion. A seronegatve subject is a subject for whom anti-CMV IgG antibodies were not detected in serum sample collected at Month 0. CMV primary infection is defined as the first infection with CMV in subjects who were seronegative at enrollment. Antibody concentrations were assessed by ELISA, tabulated as geometric mean concentrations (GMC) and expressed as EL.U/mL. The cut-off of the assay = 0.668 EL.U/mL.|From study Month 0 to Month 36|This analysis was performed on the seronegative subjects with available results at the specified timepoints, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2647665|NCT01691820|Secondary|Number of CMV Seronegative Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.|This outcome was part of the assessment of occurrence of CMV primary infections determined in all seronegative subjects, on samples collected during the 4-month site visits until study conclusion. A seronegative subject is a subject for whom anti-CMV IgG antibodies were not detected in serum sample collected at Month 0. CMV primary infection is defined as the first infection with CMV in subjects who were seronegative at enrollment.|From study Month 0 to Month 36|This analysis was performed on the seronegative subjects with available results at the specified timepoints, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||Participants|||Count of Participants
2647666|NCT01691820|Primary|Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine|This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR), for a cut-off value > 0 copies/mL.|At Month 36|This analysis was performed on the seropositive subjects with GMC above the specified threshold, at Month 36, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures|||DNA copies/mL||95% Confidence Interval|Geometric Mean
2647667|NCT01691820|Primary|Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine|This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR), for a cut-off value > 0 copies/mL.|At Month 32|This analysis was performed on the seropositive subjects with GMC above the specified threshold, at Month 32, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures|||DNA copies/mL||95% Confidence Interval|Geometric Mean
2647668|NCT01691820|Primary|Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine|This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR), for 2 cut-off values: > 0 copies/mL and ≥ 6720 copies/mL.|At Month 28|This analysis was performed on the seropositive subjects with GMC > the specified threshold, at Month 28, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||DNA copies/mL||95% Confidence Interval|Geometric Mean
2647669|NCT01691820|Primary|Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine|This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR), for a cut-off value > 0 copies/mL.|At Month 24|This analysis was performed on the seropositive subjects with GMC above the specified threshold, at Month 24, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures|||DNA copies/mL||95% Confidence Interval|Geometric Mean
2647670|NCT01691820|Primary|Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine|This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR), for a cut-off value > 0 copies/mL.|At Month 20|This analysis was performed on the seropositive subjects with GMC above the specified threshold, at Month 20, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures|||DNA copies/mL||95% Confidence Interval|Geometric Mean
2647671|NCT01691820|Primary|Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine|This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR), for a cut-off value > 0 copies/mL.|At Month 16|This analysis was performed on the seropositive subjects with GMC > the specified threshold, at Month 16, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||DNA copies/mL||95% Confidence Interval|Geometric Mean
2647717|NCT01691560|Primary|Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4|Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain).|Baseline to 4 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2647673|NCT01691820|Primary|Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV DNA Copies (pp65 Gene) in Urine|This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR), for 2 cut-off values: > 0 copies/mL and ≥ 6720 copies/mL.|At Month 8|This analysis was performed on the seropositive subjects with GMC above the specified threshold, at Month 8, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||DNA copies/mL||95% Confidence Interval|Geometric Mean
2647674|NCT01691820|Primary|Geometric Mean CMVpp65 Antibody Concentration in Subjects Based on Number of CMV Deoxyribonucleic Acid (DNA) Copies (pp65 Gene) in Urine|This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. The concentration of DNA copies was assessed by quantitative Polymerase Chain Reaction (qPCR), for 2 cut-off values: greater than (>) 0 copies/mL and greater than or equal to (≥) 6720 copies/mL.|At Month 4|This analysis was performed on the seropositive subjects with GMC above the specified thresholds, at Month 4, from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures|||DNA copies/mL||95% Confidence Interval|Geometric Mean
2647675|NCT01691820|Primary|Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).|This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were assessed by ELISA, tabulated as geometric mean concentrations (GMC) and expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay = 0.668 EL.U/mL.|At Month 36|This analysis was performed on CMV seropositive subjects with available results at Month 36 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2647676|NCT01691820|Primary|Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).|This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were assessed by ELISA, tabulated as geometric mean concentrations (GMC) and expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay = 0.668 EL.U/mL.|At Month 32|This analysis was performed on CMV seropositive subjects with available results at Month 32 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2647677|NCT01691820|Primary|Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).|This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were assessed by ELISA, tabulated as geometric mean concentrations (GMC) and expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay = 0.668 EL.U/mL.|At Month 28|This analysis was performed on CMV seropositive subjects with available results at Month 28 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2647678|NCT01691820|Primary|Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).|This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were assessed by ELISA, tabulated as geometric mean concentrations (GMC) and expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay = 0.668 EL.U/mL.|At Month 24|This analysis was performed on CMV seropositive subjects with available results at Month 24 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2647679|NCT01691820|Primary|Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).|This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were assessed by ELISA, tabulated as geometric mean concentrations (GMC) and expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay = 0.668 EL.U/mL.|At Month 20|This analysis was performed on CMV seropositive subjects with available results at Month 20 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2647718|NCT01691560|Primary|Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8|Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.|Baseline to 8 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.|||grams||Standard Deviation|Mean
2647680|NCT01691820|Primary|Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).|This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were assessed by ELISA, tabulated as geometric mean concentrations (GMC) and expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay = 0.668 EL.U/mL.|At Month 16|This analysis was performed on CMV seropositive subjects with available results at Month 16 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2647681|NCT01691820|Primary|Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).|This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were assessed by ELISA, tabulated as geometric mean concentrations (GMC) and expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay = 0.668 EL.U/mL.|At Month 12|This analysis was performed on CMV seropositive subjects with available results at Month 12 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2647682|NCT01691820|Primary|Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).|This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were assessed by ELISA, tabulated as geometric mean concentrations (GMC) and expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay = 0.668 EL.U/mL.|At Month 8|This analysis was performed on CMV seropositive subjects with available results at Month 8 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2647683|NCT01691820|Primary|Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).|This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were assessed by ELISA, tabulated as geometric mean concentrations (GMC) and expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay = 0.668 EL.U/mL.|At Month 4|This analysis was performed on CMV seropositive subjects with available results at Month 4 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2647684|NCT01691820|Primary|Anti-CMV Tegument Protein IgG Antibody Concentration in Serum (ELISA).|This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV. Antibody concentrations were assessed by ELISA, tabulated as geometric mean concentrations (GMC) and expressed as ELISA units per milliliter (EL.U/mL). The cut-off of the assay = 0.668 EL.U/mL.|At Month 0|This analysis was performed on CMV seropositive subjects with available results at Month 0 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2647685|NCT01691820|Primary|Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.|"This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases category = subjects that had two-fold and above increases of anti-CMV IgG concentration. Four-fold and above increases = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 0.668 ELISA (Enzyme-linked immunosorbant assay) Unit per milliLiter (EL.U/mL). A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV."|At Month 36|This analysis was performed on CMV seropositive subjects with available results at Month 36 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||Participants|||Count of Participants
2647686|NCT01691820|Primary|Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.|"This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases category = subjects that had two-fold and above increases of anti-CMV IgG concentration. Four-fold and above increases = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 0.668 ELISA (Enzyme-linked immunosorbant assay) Unit per milliLiter (EL.U/mL). A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV."|At Month 32|This analysis was performed on CMV seropositive subjects with available results at Month 32 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||Participants|||Count of Participants
2647687|NCT01691820|Primary|Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.|"This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases category = subjects that had two-fold and above increases of anti-CMV IgG concentration. Four-fold and above increases = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 0.668 ELISA (Enzyme-linked immunosorbant assay) Unit per milliLiter (EL.U/mL). A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV."|At Month 28|This analysis was performed on CMV seropositive subjects with available results at Month 28 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||Participants|||Count of Participants
2647688|NCT01691820|Primary|Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.|"This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases category = subjects that had two-fold and above increases of anti-CMV IgG concentration. Four-fold and above increases = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 0.668 ELISA (Enzyme-linked immunosorbant assay) Unit per milliLiter (EL.U/mL). A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV."|At Month 24|This analysis was performed on CMV seropositive subjects with available results at Month 24 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||Participants|||Count of Participants
2647689|NCT01691820|Primary|Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.|"This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases category = subjects that had two-fold and above increases of anti-CMV IgG concentration. Four-fold and above increases = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 0.668 ELISA (Enzyme-linked immunosorbant assay) Unit per milliLiter (EL.U/mL). A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV."|At Month 20|This analysis was performed on CMV seropositive subjects with available results at Month 20 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||Participants|||Count of Participants
2647690|NCT01691820|Primary|Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.|"This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases category = subjects that had two-fold and above increases of anti-CMV IgG concentration. Four-fold and above increases = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 0.668 ELISA (Enzyme-linked immunosorbant assay) Unit per milliLiter (EL.U/mL). A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV."|At Month 16|This analysis was performed on CMV seropositive subjects with available results at Month 16 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||Participants|||Count of Participants
2647691|NCT01691820|Primary|Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.|"This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases category = subjects that had two-fold and above increases of anti-CMV IgG concentration. Four-fold and above increases = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 0.668 ELISA (Enzyme-linked immunosorbant assay) Unit per milliLiter (EL.U/mL). A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV."|At Month 12|This analysis was performed on CMV seropositive subjects with available results at Month 12 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||Participants|||Count of Participants
2647692|NCT01691820|Primary|Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.|"This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases category = subjects that had two-fold and above increases of anti-CMV IgG concentration. Four-fold and above increases = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 0.668 ELISA (Enzyme-linked immunosorbant assay) Unit per milliLiter (EL.U/mL). A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV."|At Month 8|This analysis was performed on CMV seropositive subjects with available results at Month 8 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||Participants|||Count of Participants
2648083|NCT01688102|Other Pre-specified|Gene Expression Changes in Skin|Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets.|baseline vs. 2 months||||GSEA Normalized Enrichment Score|||Number
2647693|NCT01691820|Primary|Number of CMV Seropositive Subjects With Appearance or Increase of Anti-CMV Tegument Protein IgG Antibodies in Serum.|"This outcome was part of the assessment of occurrence of CMV secondary infections determined in all seropositive subjects. Two-fold and above increases category = subjects that had two-fold and above increases of anti-CMV Immunoglobulin G (IgG) concentration. Four-fold and above increases = subjects that had four-fold and above increases of anti-CMV IgG concentration. The cut-off of the assay = 0.668 ELISA (Enzyme-linked immunosorbant assay) Unit per milliLiter (EL.U/mL). A seropositive subject is a subject for whom anti-CMV IgG antibodies were detected in serum sample collected at Month 0. CMV secondary infections are defined as either a viral reactivation or a re-infection with a new strain of CMV."|At Month 4|This analysis was performed on CMV seropositive subjects with available results at Month 4 from the According-to-Protocol cohort, which included all subjects who met all inclusion criteria and no exclusion criteria for the study, who did not have any elimination criteria during the study and who complied with the study procedures.|||Participants|||Count of Participants
2647694|NCT01691794|Primary|Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4 (Continued)|Blood urea nitrogen (*upper limit of normal [ULN]): Grade (Gr) 1=1.25-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10; Gr 4= >10. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12; Gr 3=12.1-15.0; Gr 4= >15.0. Bicarbonate (mEqL): Gr 1= 19.0-21.0; Gr 2=15.0-18.0; Gr 3=41-45; Gr 4= >45. Calcium, low (mg/dL): Gr 1=7.8-8.4; Gr 2=7.0-7.7; Gr 3=6.1-6.9; Gr 4= <6.1.Potassium (mEq/L), high: Gr 1=5.6-6.0; Gr 2=6.1-6.5; Gr 3=6.6-7.0; Gr 4= >7.0. Potassium (mEq/L), low: Gr 1=3.1-3.4; Gr 2=2.5-2.9; Gr 3=2.0-2.4; Gr 4= <2.0. Sodium (mEq/L), low: Gr 1=130-135; Gr 2=125-129; Gr 3=121-124; Gr 4= <1. Total cholesterol, fasting (mg/dL): Gr 1=200-239; Gr 2=240-300; Gr 3= >300; Gr 4=Not applicable (NA). Low-density lipoprotein (LDL) cholesterol, fasting (mg/dL): Gr 1=130-159; Gr 2=160-190; Gr 3= >190; Gr 4= NA. Glucose, low (mg/dL): Gr 1= 55-64; Gr 2=40-54; Gr 3=30-39; Gr 4= <30. Glucose, fasting (mg/dL): Gr 1=110-125; Gr 2=126-250; Gr 3=251-500; Gr 4 >500.|After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)|All participants who received at least 1 dose of study drug|||Participants|||Number
2647695|NCT01691794|Primary|Number of Participants With Laboratory Test Results Meeting the Criteria for Abnormal, Grades 1-4|Hematocrit (%): Grade (Gr) 1= ≥28.5- <31.5; Gr 2= ≥24- <28.5; Gr 3= ≥19.5- <24; Gr 4= <19.5. Hemoglobin (g/dL): Grade (Gr)1=8.5-10.0; Gr 2=7.5-8.4; Gr 3=6.50-7.4; Gr 4= <6.5. Platelets (/mm^3): Gr 1=100,000-124,999; Gr 2=50,000-99,999; Gr 3=25,000-49,999; Gr 4= <25,000. White blood cells (/mm^3): Gr 1=2000-2500; Gr 2=1500-1999; Gr 3=1000-1499; Gr 4= <1000. Neutrophils (/mm^3): Gr 1=1000-1500; Gr 2= ≥750-1000; Gr 3= ≥500-750; Gr 4= <500. Alanine transaminase (ALT), alkaline phosphatase (ALP), aspartate transaminase (AST) (*upper limit of normal [ULN]): Gr 1=1.5-2.5; Gr 2=2.6-5.0; Gr 3=5.1-10.0; Gr 4= >10.0. Total bilirubin (adult and pediatric >14 days) (*ULN): Gr 1=1.1-1.5; Gr 2=1.6-2.5; Gr 3=2.6-5.0; Gr 4= >5.0. Albumin (g/dL): Gr 1= 3.1- <LLN; Gr 2=2.0-2.9; Gr 3= <2.0; Gr 4=NA. Amylase (*ULN): Gr 1=1.10-1.39; Gr 2=1.40-2.09; Gr 3=2.10-5.0; Gr 4= >5. Lipase (*ULN): Gr 1=1.1-1.5; Gr 2=1.6-3.0; Gr 3=3.1-5.0; Gr 4= >5.0.|After first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)|All participants who received at least 1 dose of study drug|||Participants|||Number
2647696|NCT01691794|Primary|Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, Grade 2-4 Related AEs, Grade 3-4 AEs, and Centers for Disease Control (CDC) Class C AIDS Events|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|From first dose to last dose plus 30 days (assessed up to February 2017, approximately 42 months)|All participants who received at least 1 dose of study drug|||Participants|||Number
2647697|NCT01691781|Secondary|Serum Calcium Following 1 Week of ACE Inhibitor Administration||1 week||||mg/dL||Standard Deviation|Mean
2647698|NCT01691781|Secondary|Urinary Aldosterone Excretion Measurements Following 1 Week of ACE Inhibitor Therapy||1 week||||mcg/24 hours||Standard Deviation|Mean
2647699|NCT01691781|Primary|Parathyroid Hormone Following 1 Week of ACE Inhibitor Administration|PTH values 1 week following ACE inhibitor therapy|1 week||||pg/mL||Standard Deviation|Mean
2647700|NCT01691768|Secondary|Product Acceptability|This is the number of participants who reported that they liked the study product. The questionnaire was administered at study exit, therefore participants who were loss to follow-up and those who died could not complete the questionnaire.|At study completion, up to 28 months|Participants who completed product acceptability questionnaire at study exit|||Participants|||Count of Participants
2647701|NCT01691768|Secondary|Percentage of Participants With Detectable Tenofovir Levels From Vaginal Samples at 12 Months of Follow-up|Percentage of participants with detectable tenofovir levels from vaginal samples at 12 months of follow-up. All drug levels below limit of quantification were considered to be undetectable.|All participants with drug levels at 12 months of follow-up|All participants with drug levels measured at 12 months of follow-up|||percentage of participants||95% Confidence Interval|Number
2647702|NCT01691768|Secondary|Human Papillomavirus Incidence Rates|For the calculation of the incidence rate, seroconversion was assumed to have occurred at the midpoint between the first positive HPV test and the previous HPV negative test.|Between 2012 and 2015, up to 28 months|This is the subset of intent to treat population. It includes all participants who had HPV negative results at randomisation.|||Incidence rate/100 women years||95% Confidence Interval|Number
2647703|NCT01691768|Secondary|Tenofovir Resistance Among HIV Seroconverters||Between 2012 and 2015, up to 28 months|Due to lack of funding, tenofovir resistance testing was not done in this study. However, we do have stored samples to fall back onto, should we secure funding.||||||
2647704|NCT01691768|Secondary|HIV Viral Load Among HIV Seroconverters|This is mean log transformed HIV viral load measured at the first visit post HIV infection.|Between 2012 and 2015, up to 28 months|All participants who became HIV infected|||log10 copies/ml||Standard Deviation|Mean
2648299|NCT01686451|Other Pre-specified|Comparison of XueZhiKang With Simvastatin of Physical Activity Level|At baseline and week 4, we estimated physical activity level by short version of international physical activity questionnaire (IPAQ) with categorical score ranged from low to high. The higher score was meaning of lower physical activity level.|Measured at baseline and week 4||||participants|||Number
2647705|NCT01691768|Secondary|Percentage of Participants Achieving Adherence >80%.|Self-reported adherence to the tenofovir gel dosing strategy.Gel adherence was defined as the estimated proportion of reported sex acts covered by two gel doses and calculated for each woman by dividing half the number of returned used applicators each month by the number of reported sex acts that month.For participants attending 2-3 monthly clinic visits, their number of gels used in the last 30 days will be estimated as the total number of returned used gels, divided by the number of days between the current and the previous visit, times 30.|Between 2012 and 2015, up to 28 months|This is a subset of intent to treat population. It includes all participants who returned used gel applicators and also reported sex during follow-up.|||percentage of participants||95% Confidence Interval|Number
2647706|NCT01691768|Secondary|Pregnancy Incidence Rates|Time to pregnancy, was as the difference between the estimated date of conception and the enrolment date, plus one. The date of conception was defined as 14 days after the last normal menstrual period or the estimated date of delivery minus 40 weeks if the first date of last normal menstrual period is not available or the midpoint between the date of the first positive pregnancy test and the date of the previous negative pregnancy test. The censoring time for a woman who did not become pregnant during the study equals the difference between the calculated censoring date and the enrolment date, plus one.|Between 2012 and 2015, up to 28 months|Intent to treat population(all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data).|||Incidence rate/100 women years||95% Confidence Interval|Number
2647707|NCT01691768|Secondary|HIV Incidence Rates|Time to HIV infection was calculated as the difference between estimated date of infection (midpoint between the last negative HIV test date and the first confirmed positive HIV test date) and enrolment date, plus one. Where a participant has a positive PCR and a negative rapid test on the same date, the date of infection is calculated as 14 days prior to this date. Women who do not become HIV positive before their last study visit will be censored on the day of their last negative HIV test. Their follow-up time will be calculated as the difference between date of censoring and enrolment date, plus one.|Between 2012 and 2015, up to 28 months|Intent to treat population(all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data).|||Incidence rate/100 women years||95% Confidence Interval|Number
2647708|NCT01691768|Primary|Mean Number of Returned Used Applicators Per Month (i.e in 30 Days)|The primary endpoint is the mean number of returned used applicators per month. Since participants in the intervention arm followed two and three monthly schedule (as opposed to monthly in the intervention arm), the number of returned used applicators per month for each participant will be estimated as the total number of returned applicators at that visit divided by the number of days since the previous visit, multiplied by 30. Thus a uniform distribution of gel use will be assumed in participants whom we did not see monthly. Intent to treat and per protocol analyses were carried out of this outcome. Intent to treat population includes all participants who were randomized, met pre-randomization eligibility criteria and who have post-enrollment follow-up data. The per protocol population is a subset of the intent to treat population.The per-protocol analysis excluded visits where no gel had been dispensed for >120 days.|Between 2012 to 2015, up to 28 months|Intent to treat population and the per protocol population (excluding all subsequent data collected from participants who were not dispensed product for more than 120 days).|||Used gel applicators per month||95% Confidence Interval|Least Squares Mean
2647709|NCT01691690|Secondary|Time of First Opioid Analgesia in PACU|Mean time to first drug administration among patients requiring opioid analgesia in the PACU.|0-90 minutes post-operatively||||minutes||Standard Deviation|Mean
2647710|NCT01691690|Secondary|Analgesics Administered After Arrival to Inpatient Ward and Number of Participants Requiring Each|Analgesics administered after arrival to the inpatient ward included hydrocodone/acetaminophen, oxycodone, NSAIDS, acetaminophen, and morphine.|8-12 hours post-operatively|Comparing both groups for the time study subjects required breakthrough pain medication on the ward.|||Participants|||Count of Participants
2647711|NCT01691690|Primary|FLACC Pain Score Greater Than or Equal to 4|The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. 5 pain measurements were performed at 0, 5, 15, 30, and 60 minutes after PACU arrival. This is the number of participants who reached a FLACC score >/= 4 at one or more time points.|0-60 mins post-operatively||||Participants|||Count of Participants
2647712|NCT01691612|Secondary|Change From Baseline in the Percentage of Total White Blood Cell That Were Neutrophils at 48 Hours|Neutrophils have some zero values pre-challenge, so absolute change is reported instead of percent change: post-pre from baseline to 48 hours|from baseline to 48 hours||||percent of white blood cells||Full Range|Mean
2647713|NCT01691612|Secondary|Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Macrophages at 48 Hours|Percent change in percentage of total white blood cell that were macrophages is measured from pre-challenge to post-challenge as: [100% * ((Post-Pre)/Pre)]|from baseline to 48 hours||||percent change||Full Range|Mean
2647714|NCT01691612|Secondary|Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Lymphocytes at 48 Hours|Percent change in percentage of total white blood cell that were lymphocytes is measured from pre-challenge to post-challenge as: [100% * ((Post-Pre)/Pre)]|from baseline to 48 hours||||percent change||Full Range|Median
2647715|NCT01691612|Primary|Change From Baseline in the Percentage of Total White Blood Cell That Were Eosinophils at 48 Hours|"Measure Pin1 activity in BAL-derived eosinophils after House Dust Mite (HDM) allergen challenge:~Eosinophils post-challenge change from pre-challenge is reported: absolute change = [eosinophils post (%) - eosinophils pre (%)]"|from baseline to 48 hours||||percent of white blood cells||Full Range|Median
2647716|NCT01691560|Primary|Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8|Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain).|Baseline to 8 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2648330|NCT01685840|Secondary|Resource Utilization Cost|Observed Hospital-Based Cost.|24 months|US Patients with billing data|||2016 US dollars||Standard Deviation|Mean
2647719|NCT01691560|Primary|Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.|Baseline to 8 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2647720|NCT01691560|Primary|Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4|Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.|Baseline to 4 weeks post administration of study treatment|ITT population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.|||grams||Standard Deviation|Mean
2647721|NCT01691560|Primary|Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.|Baseline to 4 weeks post administration of study treatment|Intent to Treat (ITT) population: All randomized participants administered with at least one study treatment during the study and provided at least one post baseline assessment of efficacy.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2647722|NCT01691534|Secondary|EBA Expressed as the Daily Percentage Change in TTP Signal in Liquid Culture for M. Tuberculosis (Days 7-14)||Days 7-14|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data|||percentage of change in time/day||95% Confidence Interval|Mean
2647723|NCT01691534|Secondary|EBA Expressed as the Daily Percentage Change in TTP Signal in Liquid Culture for M. Tuberculosis (Day 0-2)||Day 0-2|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data|||percentage of change in time/day||95% Confidence Interval|Mean
2647724|NCT01691534|Secondary|EBA Expressed as the Daily Percentage Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-14)||Days 0-14|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data|||percentage of change in time/day||95% Confidence Interval|Mean
2647725|NCT01691534|Secondary|EBA Measured as the Daily Rate of Change in log10 CFUs of M. Tuberculosis in Sputum on Solid Media (Days 7-14)||Day 7-14|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data|||log10CFU/ml/day||95% Confidence Interval|Mean
2647726|NCT01691534|Secondary|EBA Measured as the Daily Rate of Change in log10 CFUs of M. Tuberculosis in Sputum on Solid Media (Days 0-2)||Days 0-2|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data|||log10CFU/ml/day||95% Confidence Interval|Mean
2647727|NCT01691534|Primary|Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-14).||14 consecutive days of treatment|Efficacy population: all patients included in the safety population for whom corresponding efficacy data were available and had no major protocol violations/deviations defined as protocol violations/deviations affecting the integrity of the efficacy data|||log10CFU/ml/day||95% Confidence Interval|Mean
2647728|NCT01691521|Secondary|Mean Change From Baseline in the St. George's Respiratory Questionnaire Total Score at Week 32|The St. George's Respiratory Questionnaire is an established instrument, comprising 50 questions, evaluating symptoms, activity, and impacts; to measure Quality of Life in participants with diseases of airway obstruction and to elicit the participant's opinion of his/her health. The lowest possible value is zero and the highest possible value is 100. The higher values correspond to greater impairment in quality of life. The questionnaire was administered at Baseline (Visit 2) and at the Exit Visit (approximately 4 weeks after the last dose of study treatment). The change from baseline is defined as the difference between the value of the endpoint at the time point of interest and the baseline value. Analysis performed using analysis of covariance with covariates of baseline, region, baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), baseline % predicted FEV1, and treatment.|Baseline, Week 32|ITT Population. Note that only participants with a Baseline and Week 32 assessment were included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2647729|NCT01691521|Secondary|Mean Change From Baseline in Clinic Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 32|FEV1 is defined as the volume of air expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and the baseline value. Analysis performed using mixed model repeated measures with covariates of baseline, region, baseline maintenance OCS therapy (OCS vs. no OCS), exacerbations in the year prior to the study (as an ordinal variable), treatment and visit, plus interaction terms for visit by baseline and visit by treatment group.|Baseline, Week 32|ITT Population. Only participants with a Baseline FEV1 available and at least one post-Baseline FEV1 measurement were analyzed.|||Milliliters (mL)||Standard Error|Least Squares Mean
2647730|NCT01691521|Secondary|Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an ICU) Per Year|Clinically significant exacerbations of asthma is defined as worsening of asthma which required use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose|ITT Population|||Number of exacerbations per year|||Number
2647731|NCT01691521|Secondary|Number of Clinically Significant Exacerbations Requiring Hospitalization (Including Intubation and Admittance to an Intensive Care Unit [ICU]) or ED Visits Per Year|Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose|ITT Population|||Number of exacerbations per year|||Number
2647732|NCT01691521|Primary|Number of Clinically Significant Exacerbations of Asthma Per Year|Clinically significant exacerbations of asthma are defined as worsening of asthma which required use of systemic corticosteroids (IV or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance of systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visits. The frequency of clinically significant exacerbations of asthma over the 32-week treatment period is expressed as the number of exacerbations per year. Analysis of the number of exacerbations performed using a negative binomial model with covariates of treatment group, baseline maintenance OCS therapy (OCS vs. no OCS), region, exacerbations in the year prior to the study (as an ordinal variable) and baseline % predicted FEV1, and with logarithm of time on treatment as an offset variable.|From randomization (Week 0) to Week 32 or if Early Withdrawal (EW) 4 weeks post last dose|Modified Intent-to-Treat (ITT) Population: all participants who were randomized and who received at least one dose of trial medication. ‘Modified’ implies that, in cases where there is is a discrepancy between randomized and actual treatment the analysis used the actual treatment received by the participant rather than the randomized treatment.|||Number of exacerbations per year|||Number
2647733|NCT01691508|Secondary|Median Percentage Change From Baseline in Daily OCS Dose During Weeks 20 to 24 While Maintaining Asthma Control|BL dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. MN dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent change of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (MN dose minus BL dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. For participants who withdrew from the study prior to the Maintenance Phase, and for participants with a lack of asthma control during the Maintenance Phase, a value equal to the minimum percent reduction in OCS use across all subjects was imputed for the analysis.|Baseline; Weeks 20 to 24|ITT Population|||Percentage reduction in OCS dose||95% Confidence Interval|Median
2647734|NCT01691508|Secondary|Number of Participants Who Achieved a Total Reduction of OCS Dose During Weeks 20 to 24 While Maintaining Asthma Control|MN dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. The number of participants who achieved a total reduction of OCS dose was based on the value of the MN dose. Total reduction implied no OCS use during the entire MN phase. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.|Weeks 20 to 24|ITT Population|||Participants|||Number
2647735|NCT01691508|Secondary|Number of Participants Who Achieved a Reduction of Their Daily OCS Dose to <=5.0 mg During Weeks 20 to 24 While Maintaining Asthma Control|Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. Number of participants who achieved a reduction of their daily OCS dose to <=5.0 mg was based on the value of the MN dose. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.|Weeks 20 to 24|ITT Population|||Participants|||Number
2647781|NCT01691092|Primary|Change in Glutamate Levels at Baseline and After Ketamine Administration as Confirmed by Positron Emission Tomography (PET) Imaging|PET imaging obtained in healthy and Major Depressive Disorder (MDD) subjects. Glutamate levels determined by radiotracer uptake in PET images.|1st scan: 90 minute baseline scan; 2nd scan: 90 minutes, ketamine administration at start of scan; scan 3: 90 minute scan 24 hours post ketamine|13 healthy (6 males, 7 females) and 14 MDD non-smokers (4 males, 10 females) Mean age: 33.5 ± 13.2 yrs reasons for discrepancy (participant flow module): some data was not able to be analyzed due to elevated metabolites; some subject did not tolerate ketamine and had to be pulled out of scanner so we could not obtain data.|||percentage reduction||Standard Deviation|Mean
2648331|NCT01685840|Secondary|Resource Utilization|Observed Resource Use|24 months|US Patients in Economics Substudy|||events||Standard Deviation|Mean
2647736|NCT01691508|Secondary|Number of Participants Who Achieved a Reduction of >=50% in Their Daily Oral Corticosteroid (OCS) Dose Compared With Baseline Dose, During Weeks 20 to 24 While Maintaining Asthma Control|Baseline (BL) dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent reduction of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (BL dose minus MN dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. Analysis was performed using a binary logistic regression model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.|Baseline; Weeks 20 to 24|ITT Population|||Participants|||Number
2647737|NCT01691508|Primary|Number of Participants With the Indicated Percent Reduction From Baseline in Oral Corticosteroid (OCS) Dose During Weeks 20 to 24 While Maintaining Asthma Control|Baseline (BL) dose was the prescribed optimized prednisone/prednisolone dose following the OCS Optimization Phase. Maintenance (MN) dose was the mean of all daily prednisone/prednisolone doses during the MN Phase (weeks 20 to 24). The percent reduction of OCS dose during weeks 20 to 24 compared to BL dose was calculated as: 100 x (BL dose minus MN dose)/BL dose. Asthma control between weeks 20 and 24 was defined as no clinically significant exacerbation (worsening of asthma that required use of systemic corticosteroids or hospitalization and/or emergency department visits) during this period. The percent reduction of OCS was categorized as: 90 to 100%; 75 to <90%; 50 to <75%; >0 to <50%; no decrease in prednisone dose, or lack of asthma control, or withdrawal (WD) from treatment. Analysis was performed using a proportional odds model with terms for treatment group, region, duration of OCS use at BL (<5 years vs. >=5 years) and BL OCS dose.|Baseline; Weeks 20 to 24|Intent-to-Treat (ITT) Population: all participants who were randomized and who received at least one dose of study medication.|||Participants|||Number
2647738|NCT01691482|Secondary|Variability in Daily IC, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum)|IC is the the total amount of air that can be drawn into the lungs after normal expiration. During each study period, pre- and post-bronchodilator spirometry for evaluation of IC was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily IC was measured as the fluctuation around the mean IC data collected from Day 1 to Day 10. Variability was measured by the coefficent of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is half the difference between the maximum and minimum IC values.|up to 10 days|Efficacy Population|||Liters||Standard Deviation|Mean
2647739|NCT01691482|Secondary|Variability in Daily Inspiratory Capacity (IC), Estimated by Coefficient of Variation|IC is the the total amount of air that can be drawn into the lungs after normal expiration. During each study period, pre- and post-bronchodilator spirometry for evaluation of IC was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily IC was measured as the fluctuation around the mean IC data collected from Day 1 to Day 10. Variability was measured by the coefficent of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is the difference between the maximum and minimum IC values.|up to 10 days|Efficacy Population|||Liters||Standard Deviation|Mean
2647740|NCT01691482|Primary|Variability in Daily FEV1, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum Values)|FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily FEV1 was measured as the fluctuation around the mean FEV1 data collected from Day 1 to Day 10. Variability was measured by the coefficient of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is half the difference between the maximum and minimum FEV1 values.|up to 10 days|Efficacy Population|||Liters||Standard Error|Mean
2647741|NCT01691482|Secondary|Percentage of Days for Which Participants Achieved a Threshold Increase From Baseline in FEV1 of 100 mL, 200 mL, and 250 mL|FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours).|up to 35 days|Efficacy Population|||percentage of days||Standard Deviation|Mean
2647742|NCT01691482|Secondary|Percentage of Days for Which Participants Achieved a >=12% and 200 Milliliter (mL) Increase From Baseline in FEV1|FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours).|up to 35 days|Efficacy Population|||percentage of days||Standard Deviation|Mean
2647743|NCT01691482|Secondary|The Maximal Bronchodilator Response for the First Administered Agent|The maximal bronchodilator response for the first administered agent is defined as the FEV1 (the maximal amount of air that can be forcefully exhaled in one second) 1 hour post-dose of the first bronchodilator minus the pre-dose. The maximal bronchodilator response for the second agent is defined as the FEV1 1 hour post-dose of the second bronchodilator minus the FEV1 at 1 hour post-dose of the first bronchodilator. The maximal bronchodilator response for the combination is defined as the FEV1 (the maximal amount of air that can be forcefully exhaled in one second) at 1 hour post-administration of the second bronchodilator minus the corresponding pre-dose FEV1. Derived FEV1 response is FEV1 change from 0 hours (0H) for the first agent assessment (at 1 hour [1H]); change from 1H for the second agent assessment (at 2 hours [2H]); and change from 0H for the combination assessment (at 2H). Data were adjusted for FEV1, smoking status, and center.|up to 10 days|Efficacy Population|||Liters||Standard Error|Least Squares Mean
2647744|NCT01691482|Primary|Variability in Daily FEV1, Estimated by Coefficient of Variation|FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily FEV1 was measured as the fluctuation around the mean FEV1 data collected from Day 1 to Day 10. Variability was measured by the coefficient of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is the difference between the maximum and minimum FEV1 values.|up to 10 days|Efficacy Population: participants in the Intent-to-Treat Population (all participants who were randomized and received at least one bronchodilator in the treatment period) who completed pre- and post- bronchodilator assessments for at least 17 visits, with no more than 3 consecutive missing days|||Liters||Standard Error|Mean
2647745|NCT01691430|Secondary|Subjects With 1, 2, or 3 Episodes of UTIs|Suspected UTI episodes that are recorded in the medical record by the primary provider will be reviewed by chart review, symptoms will be recorded, and two adjudicators will determine if the definition of symptomatic UTI is met.|One year|There were 10 symptomatic UTIs in the treatment group (8 participants with 1 episode and 1 participant with 2 episodes) and 12 symptomatic UTIs in the control group (7 participants with 1 episode, 1 participant with 2 episodes, and 1 participant with 3 episodes).|||participants|||Number
2647746|NCT01691430|Other Pre-specified|Adherence to Capsule Intake by All Participants|measured by capsules removed from blister packs|One year||||percentage of capsules|||Number
2647747|NCT01691430|Other Pre-specified|Number of Adverse Events in Participants||One year||||adverse events|||Number
2647748|NCT01691430|Secondary|Number of Antibiotic Prescriptions for Suspected UTI|Chart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant's suspected UTI.|One Year||||prescriptions|||Number
2647749|NCT01691430|Secondary|Bacteriuria With Multidrug-resistant Gram-negative Bacilli|All urine culture data will be reviewed to determine presence of multidrug-resistant gram-negative bacilli (resistance to ≥3 of the following antibiotics: ampicillinsulbactam,cefazolin, ceftriaxone, ceftazidime, fluoroquinolones, piperacillin-tazobactam, meropenem, imipenem, and trimethoprim-sulfamethoxazole).|One year||||episodes|||Number
2647750|NCT01691430|Secondary|Number of Antibiotic Prescriptions|Chart review will be performed to determine the names and duration of antibiotic prescriptions prescribed by the primary provider on each participant.|One year||||prescriptions|||Number
2647751|NCT01691430|Secondary|Number of Deaths||One year||||participants|||Number
2647752|NCT01691430|Secondary|Number of Hospitalizations||One year||||hospitilizations|||Number
2647753|NCT01691430|Secondary|Number of Episodes of Symptomatic UTI|Suspected UTI episodes that are recorded in the medical record by the primary provider will be reviewed by chart review, symptoms will be recorded, and two adjudicators will determine if the definition of symptomatic UTI is met.|One year||||symptomatic urinary tract infections|||Number
2647754|NCT01691430|Primary|Participants With Urine Cultures With Bacteriuria (>100,000 Cfu/ml or >=100,000 Cfu/ml) Plus Pyuria (Any WBC)|Clean catch urine cultures and urinalyses will be obtained every two months for each participant for study purposes.|One year|147 subjects completed 1 year, 33 died. 20 subjects, 9 in the treatment group v 11 in the control group, became incontinent prior to the first time point, thus unable to provide any urine. 45 subjects stopped taking the capsules, 24 in treatment and 21 in control; 21 refused, 19 transitioned to hospice, 4 started warfarin, and 1 refused via family.|||participants|||Number
2647755|NCT01691378|Secondary|Beck Depression Inventory (BDI -II)|The Beck Depression Inventory-Second Edition (BDI-II) is a self-report instrument measuring the severity of common depressive symptoms. Each of its 21 items is rated on a 4-point Likert scale ranging from 0 to 3; total scores range from 0 to 63, with higher scores indicating greater degrees of depressive symptomatology. High levels of internal consistency (Cronbach α = 0.93) have been reported as well as concurrent validity with the BDI (r = 0.64 to r = 0.75), and the BHS among those with TBI (r = 0.60) (Beck and Steer, 1998) and general population samples (r = 0.52 to r = 0.63). (Beck and Steer, 1993). BDI-II outcome administered at the following study timepoints: Time 1 (Baseline for both arms), Time 2 (Post-Intervention for WtoH Intervention arm and Baseline 2 for Waitlist Control arm), and Time 3 Assessment (3 month follow up for WtoH Intervention arm and Post-Intervention for Waitlist Control arm|Time 2 BDI-II was assessed 3-months after Time 1 baseline assessment for both arms of the trial. Time 3 BDI-II was assessed 6 months after Time 1 baseline for both arms of the trial.|n=14 WtoH and n=16 Waitlist BDI-II analyzed at Time 3 due to loss to follow-up|||score on a scale||Standard Deviation|Mean
2647756|NCT01691378|Secondary|Beck Scale for Suicidal Ideation (BSS)|The BSS is a 19-item scale that assesses severity of suicide ideation within the previous week with total scores ranging from 0 (no suicide ideation) to 38. High levels of internal consistency (Cronbach's α = .93) and concurrent validity have been reported with the Beck Depression Inventory (r =.64 to r =.75, Beck & Steer, 1993) as well as the BHS in Traumatic Brain Injury (TBI) (r =.60, Simpson & Tate, 2002) and non-brain-damaged populations (r =.52 to r = .63, Beck & Steer, 1993). BSS outcome administered at the following study timepoints: Time 1 (Baseline for both arms), Time 2 (Post-Intervention for WtoH Intervention arm and Baseline 2 for Waitlist Control arm), and Time 3 Assessment (3 month follow up for WtoH Intervention arm and Post-Intervention for Waitlist Control arm|Time 2 BSS was assessed 3-months after Time 1 baseline assessment for both arms of the trial. Time 3 BSS was assessed 6 months after Time 1 baseline for both arms of the trial.|n=14 WtoH and n=19 Waitlist analyzed at Time 2 assessment due to incomplete BSS data for n=2 participants; n=13 WtoH and n=15 Waitlist BSS analyzed at Time 3 due to loss to follow-up|||score on a scale||Standard Deviation|Mean
2647782|NCT01691027|Secondary|Stylus to Eclipse Area||Base line, Pre and Post training (approximately 3 months)|Out of Ten selected subjects, 3 were rejected after completing Baseline SLO retinal function map because of residual foveal vision. Two subjects failed to follow the instructions for SLO testing. One subject completed initial phase but failed to complete testing because of medical problems. Four subjects were able to complete all testing.|||Degree|||Number
2651526|NCT01661686|Secondary|Number of Participants With Technical Success of SEMS Placement|Technical succes was defined as succesful deployment of the stent which bridges the stricture|At stent placement (t=0)||||Participants|||Count of Participants
2647757|NCT01691378|Primary|Beck Hopelessness Scale (BHS)|The BHS is a 20-item true-false self-report scale that measures the level of negative expectations about the future held by respondents over the previous week. Scores range from 0 to 20 representing nil (0-3), mild (4-8), moderate (9-14), and severe (>14) levels of hopelessness. Beck et al. found that BHS scores equal to or greater than 9 were associated with significantly elevated levels of suicide risk (Beck et al., 1985). As such, to be eligible to participate in this treatment trial individuals must have a score of 9 on the BHS at the time of screening and at the Time 1 baseline assessment. BHS outcome administered at the following study timepoints: Time 1 (Baseline for both arms), Time 2 (Post-Intervention for WtoH Intervention arm and Baseline 2 for Waitlist Control arm), and Time 3 Assessment (3 month follow up for WtoH Intervention arm and Post-Intervention for Waitlist Control arm.|Time 2 BHS was assessed 3-months after Time 1 baseline assessment for both arms of the trial. Time 3 BHS was assessed 6 months after Time 1 baseline for both arms of the trial.|Participants were included in the outcome analysis if they completed the Time 2 assessment. N=14 participants from the WtoH Intervention first arm and n=16 participants from the Waitlist Control arm were analyzed at Time 3 due to loss to follow-up.|||score on a scale||Standard Deviation|Mean
2647758|NCT01691339|Other Pre-specified|Number of Participants With Influenza Antibody Titers of <1:10 Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay to determine pre-vaccination and post-vaccination titers of <1:10.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Antibody responses to the influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2647759|NCT01691339|Other Pre-specified|Number of Adult Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroconversion was defined as either a pre-vaccination titer < 10 (1/dil) and a post-vaccination titer ≥ 40 (1/dil), or a pre-vaccination titer ≥ 10 (1/dil) and a ≥ 4-fold increase in post-vaccination titer.|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroconversion to the influenza virus vaccine antigens was assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2647760|NCT01691339|Other Pre-specified|Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before and Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay. Seroprotection was defined as a pre-vaccination or a post-vaccination titer ≥ 40 (l/dil).|Day 0 (pre-vaccination) and Day 21 post-vaccination|Seroprotection against influenza vaccine antigens were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2647761|NCT01691339|Other Pre-specified|Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) up to Day 21 post-vaccination|Geometric mean titers against the influenza virus antigens were assessed in the Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2647762|NCT01691339|Primary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Fluzone® or Fluzone® Intradermal or Fluzone® High-Dose Vaccine|"Solicited injection site: Pain, Erythema, Swelling, Induration, and Ecchymosis; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.~Grade 3 injection site: Pain - Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - >100 mm. Grade 3 systemic reactions: Fever ≥39.0°C; Headache, Malaise, Myalgia, and Shivering - significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
2647763|NCT01691326|Other Pre-specified|Geometric Mean Titer Ratios (GMTRs) of Antibodies to Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).|Influenza virus antibodies were measured using a HAI assay. Geometric mean titer ratio is the geometric mean of the individual post-vaccination / pre-vaccination titer of antibodies to the influenza virus antigens|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titer ratios against the influenza virus antigens were assessed in the Per-protocol Analysis Set.|||Ratio||95% Confidence Interval|Geometric Mean
2647764|NCT01691326|Other Pre-specified|Number of Participants With Seroconversion Against Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)|Influenza virus antibodies were measured using a HAI assay. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and a post-vaccination titer ≥40 (1/dilution), or a pre-vaccination titer ≥10 (1/dilution) and ≥4-fold increase in titer 28 days after final vaccination.|Day 28 after final vaccination|Seroconversion against the influenza virus antigens were assessed in the Per-protocol Analysis Set.|||Participants|||Number
2647765|NCT01691326|Other Pre-specified|Number of Participants With Seroprotection Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)|Influenza virus antibodies were measured using a HAI assay. Seroprotection was defined as a titer ≥40 (1/dilution).|Day 0 (pre-vaccination) and Day 28 after final vaccination|Seroprotection against the influenza virus antigens were assessed in the Per-protocol Analysis Set.|||Participants|||Number
2647766|NCT01691326|Other Pre-specified|Geometric Mean Titers of Antibodies to Influenza Antigens Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).|The influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 0 (pre-vaccination) and Day 28 after final vaccination|Geometric mean titers of antibodies against the influenza virus antigens were assessed in the Per-protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2647783|NCT01691027|Primary|Improvement in Eye-hand Coordination|Maze tracing represents the fine eye-hand coordination needed for a wide variety of manual tasks and an improvement in maze tracing indicates an improvement in eye-hand coordination|base line, pre-test, post tracing and videogames training|Out of Ten selected subjects, 3 were rejected after completing Baseline SLO retinal function map because of residual foveal vision. Two subjects failed to follow the instructions for SLO testing. One subject completed initial phase but failed to complete testing because of medical problems. Four subjects were able to complete all testing.|||Percentage|||Number
2673279|NCT01462877|Primary|Percentage of Triglyceride (TG) Change|Blood tests|Baseline and up to 8 weeks after intervention|Full Analysis Set|||percentage of TG change||Standard Deviation|Mean
2647767|NCT01691326|Primary|Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)|"Solicited injection site reactions (Age 6 to < 24 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability.~Grade 3: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Fever, >103.1°F; Vomiting, ≥6 episodes/24 hours; Abnormal crying, >3 hours; Drowsiness, Sleeping most of the time; Loss of appetite, Refuses ≥3 feeds/meals or most feeds/meals; Irritability, Inconsolable.~Solicited injection site reactions (Age 24 Months to < 9 Years): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.~Grade 3: Pain, Incapacitating, unable to perform usual activities; Redness and Swelling, ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise, and Myalgia, Significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.|||Participants|||Number
2647768|NCT01691313|Primary|Conversion to Sinus Rhythm|proportion of subjects who convert to sinus rhythm through 24 hours after start of study drug|baseline through 24 hours||||participants|||Number
2647769|NCT01691313|Primary|Conversion to Sinus Rhythm|proportion of subjects who convert to sinus rhythm through 4 hours after start of study drug|baseline through 4 hours||||participants|||Number
2647770|NCT01691248|Secondary|Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to Day 70 of Study.|CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.|Up to Day 70 of study|mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2647771|NCT01691248|Secondary|Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 60 Days Post-treatment.|CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.|Up to 60 days post-treatment|mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2647772|NCT01691248|Primary|Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 30 Days Post-treatment Follow-up.|CDAD is defined as follows: Diarrhea: (change in bowel habits with >3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.|Up to 30 days post-treatment|mITT consisting of all randomized participants undergoing HSCT who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2647773|NCT01691105|Secondary|Number of Participants Self-Reporting Treatment Engagement - 1 Month|Treatment engagement will be assessed by subject self-report during the 1 month follow-up interview. Subjects will be considered engaged in treatment if at 30 days after randomization the subject reports currently receiving care for the Quitline or another treatment program that addresses the subject's nicotine dependence.|1 month post enrollment||||Participants|||Count of Participants
2647774|NCT01691105|Secondary|Number of Participants Self-Reporting Use of Cessation Medications - 12 Months|NRT use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 1, 6, and 12 months post enrollment.|12 months post enrollment||||Participants|||Count of Participants
2647775|NCT01691105|Secondary|Number of Participants Self-Reporting Use of Cessation Medications - 6 Months|NRT use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 1, 6, and 12 months post enrollment.|6 months post enrollment||||Participants|||Count of Participants
2647776|NCT01691105|Secondary|Number of Participants Self-Reporting Use of Cessation Medications - 1 Month|Nicotine replacement therapy (NRT) use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 1, 6, and 12 months post enrollment.|1 month post enrollment||||Participants|||Count of Participants
2647777|NCT01691105|Secondary|Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 1 Month|Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.|1 month post enrollment|Includes only participants who completed 1 month follow-up appointment.|||participants|||Number
2647778|NCT01691105|Secondary|Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 6 Months|Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.|6 months post enrollment|Includes only participants who completed the 6 month follow-up appointment.|||participants|||Number
2647779|NCT01691105|Secondary|Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 12 Months|Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.|12 months post enrollment|Only includes participants who completed the 12 month follow-up appointment.|||participants|||Number
2647780|NCT01691105|Primary|Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence|Tobacco abstinence will be assessed by obtaining an exhaled carbon monoxide reading for all subjects self-reporting tobacco abstinence at 12 month follow-up. Consistent with manufacturer's recommendations, a cutoff of 10 ppm will indicate current smoking.|12 months post enrollment|Only participants self-reporting abstinence during the 12 month follow-up call were asked to provide biochemical verification.|||participants|||Number
2647841|NCT01690143|Primary|Frequency of Grades 3 and 4 Non-hematologic Adverse Events During the Transplant Component ( 135 Days)|Grading of AE's is performed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.|Up to 4 1/2 months||||Participants|||Count of Participants
2647784|NCT01691014|Secondary|Health Assessment Questionnaire (HAQ) Score After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Baseline, Month 3, 6 and 12|HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.|Baseline, Month 3, 6, 12|"EAS included all participants that provided at least 1 post-baseline assessment. Here, n signifies number of participants evaluable for this outcome measure at the specified time points."|||units on a scale||Standard Deviation|Mean
2647785|NCT01691014|Secondary|Disease Activity Score Based on 28-Joints Count (DAS28) After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Month 3, 6 and 12|DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS28-4 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity.|Month 3, 6, 12|EAS included all participants that provided at least 1 post-baseline assessment. Here,”n” signifies number of participants evaluable at the specified time points for this outcome measure.|||units on a scale||Standard Deviation|Mean
2647786|NCT01691014|Secondary|Correlation Between the Formation of Anti-drug Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab and Concomitant Methotrexate Treatment|Association between formation of anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and concomitant Methotrexate treatment (weekly dose of 7.5 milligram) was to be analyzed.|Month 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.||||||
2647787|NCT01691014|Secondary|Number of Participants With Anti-drug Antibodies Levels 3 and 12 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab|Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.|Month 3, 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.||||||
2647788|NCT01691014|Secondary|Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Cessation of Therapy Between Month 6 and 12 Visits|Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and cessation of therapy was to be analyzed. Cessation of therapy between month 6 and month 12 was the time to withdrawal from study due to either adverse events or lack of effect between the 6 month visit and the 12 month visit.|Month 6, 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.||||||
2647789|NCT01691014|Secondary|Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Health Assessment Questionnaire (HAQ) 12 Months After Initiation of Treatment|Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and HAQ scores was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.|Month 6, 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.||||||
2647790|NCT01691014|Secondary|Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Disease Activity Score 28 (DAS28) 12 Months After Initiation of Treatment|Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and DAS28 was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 [good condition] to 10 [worst condition]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity.|Month 6, 12|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.||||||
2647791|NCT01691014|Primary|Number of Participants With Presence of Active Drugs in Serum 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab|Presence of active drugs in serum 6 months after treatment with Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.|Month 6|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.||||||
2647792|NCT01691014|Primary|Number of Participants With Anti-drug Antibodies Formation Levels 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab|Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.|Month 6|Data was not collected since this outcome measure was not analyzed due to premature termination of the study.||||||
2647793|NCT01690988|Secondary|Adverse Outcomes (Number of Patients With Nightmares)|Assessed via Confusion Assessment Method or Confusion Assessment Method for Intensive care Unit|Postoperative days 1-3||||Participants|||Count of Participants
2647794|NCT01690988|Secondary|Adverse Outcomes (Number of Patients With Hallucinations)|Assessed via Confusion Assessment Method or Confusion Assessment Method for Intensive Care Unit|Postoperative days 1-3||||Participants|||Count of Participants
2647795|NCT01690988|Secondary|ICU and/or Hospital Length of Stay|Assessed from patients' medical charts|Postoperative period|Outcome measure data were not collected.||||||
2647842|NCT01690143|Primary|Median Time for Neutrophil and Platelet Engraftment.|Neutrophil engraftment is defined as the first of three consecutive days with absolute neutrophil count >500/mm3. Platelet engraftment is defined as the first of 3 consecutive days of platelets > 20,000/mm3 without platelet transfusion in the prior 7 days.|Up to 1 month.|All patients|||days||Full Range|Median
2647796|NCT01690988|Secondary|Number of Patients With Postoperative Nausea and Vomiting|"Assessed from patient-reported postoperative nausea and vomiting section of Behavioral Pain Scale or Behavioral Pain Scale (Non-Intubated) Patients where asked whether they currently have nausea/vomiting AM & PM the response choices: None, Mild, Moderate, Severe Incidence of nausea\vomiting accounted for any positive reporting(Mild, moderate, or sever) Daily incidence accounted for any positive incidence AM/PM in each POD Any POD nausea/vomiting reports the incidence across day 1-3~The incidence of nausea and or vomiting was compared across the three study groups Placebo vs. Lo-K (0.5 mg/kg) vs. Hi-K (1 mg/kg) for POD 1-3 and overall."|Postoperative days 1-3||||Participants|||Count of Participants
2647797|NCT01690988|Secondary|Median Opioid Consumption|"Assessed from patients' medical charts. All morphine equivalent drugs consumed by patients perioperatively~Opioid Drugs included:~* Postoperatively while still in hospital, the list of pain medication used included Morphine, Hydromorphone, Meperidine, Nalbuphine, Oxycodone,Oxymorphone, Tramadol, bupivacaine, (Codeine, Fentanyl, Naloxone) Total Opiates (Morphine Equivalent) in milligrams The median(IQR) opioid consumption was compared across the three study groups Placebo vs. Lo-K (0.5 mg/kg) vs. Hi-K (1 mg/kg)"|Postoperative days 0-3||||mg||Full Range|Median
2647798|NCT01690988|Secondary|Daily Maximum Pain Recorded|Assessed by observer-based Behavioral Pain Scale or Behavioral Pain Scale (Non-Intubated) with subsequent administration of patient-reported Visual Analog Scale The behavioral pain scale has three domains and ranges from 3 to 15. The visual analog scale is a continuous scale from 0 to 100 mm. Daily Maximum Pain accounted for pain level in the AM or PM for both the VAS and the BPS/BPS-NI a higher value means a worse outcome.|Postoperative days 1-3, two assessment daily (morning and afternoon), with at least six hours between assessments||||participants||Inter-Quartile Range|Median
2647799|NCT01690988|Primary|Number of Patients With Incidence of Delirium Across All Patients at Baseline and Over Post-operative Days 1-3|"According to Confusion Assessment Method or Confusion Assessment Method for Intensive Care Unit criteria the number of patients that had any positive CAM on any day for all patients. The main effect evaluated will be to determine whether ketamine decreases delirium, table 3 of the protocol provides a useful guide for the potential findings of the current study with their implications.~To further clarify, delirium will be assessed on the day of surgery, when possible and on the subsequent three days POD 1-3, as long as as patients remain in the hospital and are assessable (i.e., not sedated to a RASS <-3). The assessments on POD 1-3 will be done twice daily, once in the morning and once in the afternoon. The primary outcome of the study includes only the delirium incidence on POD 1-3.~The primary comparison will be between the combined ketamine groups and the placebo group."|Delirium incidence on postoperative days 1-3, calculated by any positive CAM on any day for all patients|Of all 672 participants, data were analyzed AM and PM and post operative day 1 through day 3 for screened participants with a CAM. The overall incidence of delirium were compared, Ketamine 0.5 mg/kg and 1 mg/kg groups were combined as per-specified in the study protocol.|||Participants|||Count of Participants
2647800|NCT01690923|Primary|AHI on Nasal Mask and Pillows Mask|AHI (measure of sleep-disordered breathing severity) on nasal mask and nasal pillows measured as average events/hour|7 days||||events/hour||Standard Deviation|Mean
2647801|NCT01690923|Secondary|Usability|Participant's feedback of performance of the study devices. Likert Scale 0-10 (0=very bad, 10=very good)|After 7 days of use||||Units on a scale||Inter-Quartile Range|Median
2647802|NCT01690663|Secondary|The Secondary Outcome Variable is Post Operative Motor Block Duration|This is defined as time from the completion of the block to the time when patient is able to move his or her forearm and/or hands. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.|days 1, 2, and day 7||||hours||Inter-Quartile Range|Mean
2647803|NCT01690663|Primary|Primary Outcome Variable is Post Operative Sensory Block Duration|This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after hospital discharge. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.|days 1, 2, and day 7||||hours||Inter-Quartile Range|Mean
2647804|NCT01690546|Secondary|Number of Participants That Self Reported Illicit Drug Use|Participants reported on any illicit drug use to include Cocaine marijuana opiates|4 weeks||||participants|||Number
2647805|NCT01690546|Secondary|Use of Ancillary Medications.|Number of participants that took ancillary medication|baseline to week 1||||participants|||Number
2647806|NCT01690546|Secondary|Percentage of Participants With Adherence to Medication (Naltrexone)|Participant who took Naltrexone as prescribed.|Day 1 to Day 8 (+/- 2 days)||||percentage of participants|||Number
2647807|NCT01690546|Secondary|Percentage of Participants Who Adhered to Study Visits.||baseline to end of study (approximately 40 days)||||percentage of participants|||Number
2647808|NCT01690546|Secondary|Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire|"Questionnaire consisted of 3 questions.~Were you satisfied with the treatment (range 1-5): Completely satisfied (1) to completely dissatisfied (5).~Were you satisfied with withdrawal treatment (range 1-5): Minimal withdrawal (1) to worse than ever (5).~Did the medication help (range 1-5): Helped a lot (1) to No it did not help (5).~Lower scores represent greater satisfaction."|Day 9||||units on a scale||Standard Deviation|Mean
2647809|NCT01690546|Secondary|Illicit Drug Use, Measured by Urine Drug Testing|number of participants that tested positive for marijuana, cocaine, and opiates.|4 weeks||||participants|||Number
2647810|NCT01690546|Secondary|Craving|Craving, assessed with a 100-point Visual Analog Scale (VAS), ranging from 'not at all' (0) to 'more than ever' (100). The higher the score the higher the craving.|4 weeks||||units on a scale||Standard Deviation|Mean
2647811|NCT01690546|Secondary|Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS)|"After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment.~SOWS contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). Total score range is 0 - 64; the higher the score the more withdrawal symptoms."|4 weeks||||units on a scale||Standard Deviation|Mean
2647812|NCT01690546|Secondary|Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS)|"After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment.~COWS rates eleven common opiate withdrawal signs or symptoms. The summed scores ranged from 0-48, with 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal."|4 weeks|All participants who received the Extended Release Injectable NTX|||units on a scale||Standard Deviation|Mean
2647813|NCT01690546|Primary|Retention in Treatment|After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks.|4 weeks|All participants who received the Extended Release Injectable NTX|||participants|||Number
2647814|NCT01690299|Secondary|Psoriasis Flare/Rebound|Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy. PASI ≥125% of baseline score at any visit after the last dose date for those who discontinued within the phase.|From the first dose of apremilast (either Week 0 or Week 16 for participants originally randomized to placebo or etanercept who were switched at Week 16) until 28 days after the last dose of apremilast.|Safety population includes all participants who were randomized and received at least one dose of study drug.|||participants|||Number
2647815|NCT01690299|Secondary|Psoriasis Flare/Rebound|Psoriasis flare is an AE and represents an atypical or unusual worsening of disease during treatment. It is defined as a sudden intensification of psoriasis requiring medical intervention or a diagnosis of new generalized erythrodermic, inflammatory, or pustular psoriasis. Rebound is an AE and is defined as a severe and sudden worsening of disease that occurs after treatment has been discontinued. This exacerbation is characterized by a PASI ≥125% of baseline or a new generalized pustular, erythrodermic, or more inflammatory psoriasis after stopping therapy.|Week 0 to Week 16; Placebo controlled phase|Safety population includes all participants who were randomized and received at least one dose of study drug.|||participants|||Number
2647816|NCT01690299|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Apremilast-exposure Period|A TEAE in the apremilast-exposure phase is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes listed above.|From the first dose of apremilast (either Week 0 for participants originally randomized to apremilast or Week 16 for those originally randomized to placebo or etanercept who were switched to apremilast at week 16) until 28 days after last apremilast dose|All participants who received apremilast at any time during the study.|||participants|||Number
2647817|NCT01690299|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Phase|A TEAE is an AE with a start date on or after the date of the first dose of study drug and no later than 28 days after the last dose of study drug for participants who discontinued early. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology. Any worsening (ie, clinically significant adverse change in frequency or intensity of a preexisting condition) should be considered an AE. A serious AE (SAE) is any untoward AE that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly/birth defect, or is a condition that may jeopardize or may require intervention to prevent one of the outcomes above.|Week 0 to Week 16; mean duration of exposure was 14.90 weeks for placebo group, 15.13 weeks for apremilast group and 15.87 weeks for Etanercept group|Safety population includes all participants who were randomized and received at least one dose of study drug.|||participants|||Number
2647818|NCT01690299|Secondary|Percentage of Participants Who Achieved a Lattice System Physician's Global Assessment (LS-PGA) Score of Clear (0) or Almost Clear at Week 16 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|The Lattice System Physician's Global Assessment is a global assessment performed by the investigator of psoriasis severity. Integrating ranges of BSA involvement with assessments of overall plaque severity (using a 4 point scale from none to marked for the signs of plaque elevation, erythema and scale), the LS-PGA produces an overall assessment of psoriasis severity on an 8-point scale, ranging from clear to very severe. To determine the final score, the lattice portion is governed by the BSA and among the plaque qualities, weights plaque elevation as most important, erythema next, and scale least.|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.|||percentage of participants|||Number
2647843|NCT01690143|Primary|Complete Response (CR) Rate.|CR defined as the following: Negative immunofixation of the serum and urine. If only the measurable non-bone marrow parameter was free light chain, normalization of free light chain ratio. < 5% plasma cells in bone marrow. And, disappearance of any soft tissue plasmacytomas.|Up to 17 months||||Participants|||Count of Participants
2648004|NCT01688895|Primary|The Hospital Anxiety and Depression Scale (HADS)|Questionnaire with 7 items for anxiety and 7 items for depression, each item is scored on a 4 point response 0 - 3, subscales 0-21, with full range from 0 to 42, with higher score indicating more severe anxiety or depression.|1 weeks|Data only for those who completed instrument included. A protocol modification to add the HADS tool was done after study initiation, therefore not all subjects received all tools.|||score on a scale||Standard Deviation|Mean
2647819|NCT01690299|Secondary|Change From Baseline in the Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 in Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|The SF-36 is a 36-item general health status instrument and consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better health. Scores from the 8 scales were transformed to the norm-based scores using weights from U.S. general population to have a mean of 50 and variance = 10, with higher scores indicating better health. From these 8 scale, two overall summary scores were obtained − a Physical Component Summary score (PCS) and a Mental Component Summary score (MCS), both having the same mean of 50 and variance = 10 as noted for the individual scales for the U.S. general population, and with higher scores indicating better health. For MCS, change from baseline was calculated, where change = visit value − baseline value.|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.|||units on a scale||95% Confidence Interval|Least Squares Mean
2647820|NCT01690299|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score In Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|"DLQI is a simple, compact, and practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from Very Much (score 3) to Not at All or Not relevant (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if No, then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being A lot, A little, or Not at all (scores 2, 1, or 0 respectively). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best."|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.|||units on a scale||95% Confidence Interval|Least Squares Mean
2647821|NCT01690299|Secondary|Percentage of Participants Who Achieved a 50% Improvement (Response) in the Psoriasis Area Severity Index (PASI-50) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The PASI score was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).|||percentage of participants|||Number
2647822|NCT01690299|Secondary|Percent Change From Baseline in the Affected Body Surface Area (BSA) for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|"BSA is a measurement of involved skin. The overall BSA affected by psoriasis was estimated based on the palm area of the participant's hand (entire palmar surface or handprint including the fingers), which equates to approximately 1% of total body surface area. BSA percent change from baseline was determined at each visit of the study, and is calculated as 100*(post-baseline BSA - baseline BSA) / baseline BSA."|Baseline to Week 16|mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: LOCF.|||percent change||95% Confidence Interval|Least Squares Mean
2647823|NCT01690299|Secondary|Percentage of Participants Who Achieved a Static Physician Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Points Reduction for Comparison Between Apremilast and Placebo and Etanercept and Placebo at Week 16|The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. The sPGA is a 5-point scale ranging from 0 (clear) to 4 (severe), incorporating an assessment of the severity of the three primary signs of the disease: erythema, scaling and plaque elevation. When making the assessment of overall severity, the Investigator should factor in areas that have already been cleared (ie, have scores of 0) and not just evaluate remaining lesions for severity, ie, the severity of each sign is averaged across all areas of involvement, including cleared lesions. In the event of different severities across disease signs, the sign that is the predominant feature of the disease should be used to help determine the sPGA score.|Baseline and Week 16|mITT population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).|||percentage of participants|||Number
2647844|NCT01690143|Primary|Very Good Partial Response (VGPR) Rate.|"VGPR defined as any one of the following:~≥ 90% reduction of serum M-protein; ≥ 90% reduction in 24-hour urinary M-protein or decrease to < 100 mg per 24 hour; ≥ 50% decrease in the difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio; ≥ 50% reduction in bone marrow plasma cells; ≥ 50% reduction in the size of soft tissue plasmacytomas."|Up to 17 months|All patients who underwent transplantation|||Participants|||Count of Participants
2647845|NCT01690143|Primary|Maximum Tolerated Dose (MTD) of Carfilzomib Plus Melphalan as Conditioning for Autologous Hematopoietic Cell Transplantation in Patients With Relapsed Multiple Myeloma(MM) [Phase I Portion of Study]|The maximum tolerated dose of carfilzomib that can be safely combined with high dose melphalan as conditioning regimen prior to autologous hematopoietic cell transplantation in patients with relapsed multiple myeloma meeting eligibility criteria.|Up to 4 1/2 months|Patients who underwent transplantation during phase 1|||mg/m2|||Number
2647824|NCT01690299|Secondary|Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area and Severity Index (PASI) for the Comparison Between Etanercept 50mg SC QW and Placebo at Week 16|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.|Baseline and Week 16|mITT population consisted of all participants who were re-randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).|||percentage of participants|||Number
2647825|NCT01690299|Primary|Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline|PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.|Baseline to Week 16|The modified intent-to-treat (mITT) population consisted of all participants who were randomized and received at least one dose of study drug and had both a baseline PASI and at least one post-treatment PASI evaluation. Missing data imputation: Last observation carried forward (LOCF).|||Percentage of participants|||Number
2647826|NCT01690273|Secondary|Chest Expansion|Chest expansion was measured with a tape in centimeters between inspiration and breathing exhaling. Highest score means better chest expansion. Data are expressed by means and standard deviation.|Baseline and 16 Weeks||||Centimeters||Standard Deviation|Mean
2647827|NCT01690273|Secondary|Finger Floor Distance|Distance between third finger of the hand and the floor while in lumbar flexion. It was measured with a tape in centimeters. Highest score means better torso flexion mobility. Data are expressed by means and standard deviation|Baseline and 16 Weeks||||Centimeters||Standard Deviation|Mean
2647828|NCT01690273|Secondary|Tragus-coronoid Distance|lateral flexion of the head (tragus-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral flexion mobility of the head.Data are expressed by means and standard deviation|Baseline and 16 Weeks||||Centimeters||Standard Deviation|Mean
2647829|NCT01690273|Secondary|Chin-coronoid Distance|lateral rotation of the head (chin-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral rotation mobility. Data are expressed by means and standard deviation|Baseline and 16 Weeks||||Centimeters||Standard Deviation|Mean
2647830|NCT01690273|Secondary|MASES|Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) score varying from 0 to 13. Where 0 is no painful point reported and 13 is all tender points reported as painful. Data are expressed by means and standard deviation|Baseline and 16 Weeks||||Number of painful tender points||Standard Deviation|Mean
2647831|NCT01690273|Secondary|Short Form-12 (MCS)|Quality of life was analyzed in a mental component score varying from 0 (lowest level of health) to 100 (highest level of health). Data are expressed by mean and SD.|Baseline and 16 Weeks||||units on a scale||Standard Deviation|Mean
2647832|NCT01690273|Secondary|Short Form-12 (PCS)|Quality of life was analyzed in a physical component score varying from 0 (lowest level of health) to 100 (highest level of health) scale. Data are expressed by mean and SD.|Baseline and 16 Weeks||||units on a scale||Standard Deviation|Mean
2647833|NCT01690273|Secondary|Stiffness Scale|Stiffness was measured by an VAS varying from 0 to 10. Higher scores means worst stiffness. Data are expressed by mean and SD.|Baseline and 16 Weeks||||units on a scale||Standard Deviation|Mean
2647834|NCT01690273|Secondary|Pain Scale|Pain was evaluated in a visual analogue scale (VAS) from 0 to 10. higher scores means much pain. Data was expressed by means and standard deviation.|Baseline and 16 Weeks||||units on a scale||Standard Deviation|Mean
2647835|NCT01690273|Secondary|Thoracolumbar Mobility|Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation|Baseline and 16 Weeks||||Centimeters||Standard Deviation|Mean
2647836|NCT01690273|Primary|Global Evaluation Self Reported|Bath Ankylosing Spondylitis Global is a self reported global score varying from 0 to 10. Higher scores means worst health evaluation. Expressed by means and standard deviation.|Baseline and 16 Weeks||||units on a scale||Standard Deviation|Median
2647837|NCT01690273|Primary|Ankylosing Spondylitis Disease Activity Scale -Disease Activity|Scores vary from 0 to 10, and higher than 4 scores are indicative of disease activity. Data are expressed by means and SD|Baseline and 16 Weeks||||units on a scale||Standard Deviation|Mean
2647838|NCT01690273|Primary|Disease Activity Index|BASDAI - Bath ankylosing spondylitis disease activity index. Scale from 0 to 6. Higher scores means worst disease activity. Numbers are expressed in average (SD)|Baseline and 16 Weeks||||units on a scale||Standard Deviation|Mean
2647839|NCT01690273|Primary|Mobility Index|Bath ankylosing spondylitis motion index. A mean of five mobility measures committed by Ankylosing Spondylitis disease. Higher results means higher limitations in mobility (units of measure from 0 to 10)|Baseline and 16 weeks||||units on a scale from 0 to 10||Standard Deviation|Mean
2647840|NCT01690273|Primary|FUNCTIONAL INDEX|BASFI - Bath ankylosing spondylitis functional index. A scale from 0 to 10 (lower scores means better functional capacity), results are measured by mean and standard deviation.|Baseline and 16 Weeks||||units on a scale||Standard Deviation|Mean
2647847|NCT01690130|Primary|the Change From Baseline in Cue Nicotine Craving Rating Score|Seventy highly palatable scenic images, forty neutral control images) and forty cigarette smoking cue images were presented in four blocks. Immediately after viewing each block of cue images, participants completed a 10 question computerized visual analog scale (CVAS) designed to assess craving. Each question is followed by a CVAS (range 0 - 100) 0 means least amount of craving and 100 means the maximum amount of craving. After 15 minutes of real or sham rTMS, participants viewed the images again and rated their cravings. At each visit, participants were blind to the rTMS condition (real or sham) and the order was randomized.|Before rMTS (baseline) and after rTMS experiment (on average 15 minutes)||||score on a scale||Standard Deviation|Mean
2647848|NCT01690117|Secondary|Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9|RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (no reaction) and 96 (extremely strong reaction). Change = (Month 9 Score - Baseline score)|baseline and month 9|The RMBPC reaction subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
2647849|NCT01690117|Secondary|Change From Baseline in Strength of Reaction of Caregivers to Problem Behavior on a German Version of the Reaction Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6|RMBPC reaction subscale is a validated self-reported instrument assessing the strength of reaction of caregivers to problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (no reaction) and 96 (extremely strong reaction). Change = (Month 6 Score - Baseline score)|baseline and month 6|The RMBPC reaction subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
2647850|NCT01690117|Secondary|Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 9|The frequency subscale of the RMBPC is a validated proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (never occured) and 96 (extremely often). Change = (Month 9 Score - Baseline score)|baseline and month 9|The RMBPC - frequency subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
2647851|NCT01690117|Secondary|Change From Baseline in Frequency of Problem Behavior on a German Version of the Frequency Subscale of the Revised Memory and Behavior Problem Checklist (RMBPC) - (5-point Scale) at Month 6|RMBPC frequency subscale is a validated, proxy-reported instrument assessing the frequency of problem behavior of cognitively impaired persons over the last week time period. Possible scores range from 0 (never occured) and 96 (extremely often). Change = (Month 6 Score - Baseline score)|baseline and month 6|The RMBPC - frequency subscale was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
2647852|NCT01690117|Secondary|Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9|SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 9 Score - Baseline score)|baseline and month 9|The SF-12 - physical component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
2647853|NCT01690117|Secondary|Change From Baseline in Physical Quality of Life on the German Version of the Physical Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6|SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 6 Score - Baseline score)|baseline and month 6|The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
2647854|NCT01690117|Secondary|Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 9|SF-12 is a validated, self-reported instrument assessing psychological and physical quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 9 Score - Baseline score)|baseline and month 9|The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
2647881|NCT01689779|Secondary|Percent (%) Change in Pre-surgical LL-37 Within 24 Hours of Surgery|The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of short-term changes in vitamin D status following surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37.|Patients will be followed between the day of surgery and 1 day after surgery|Data are presented as percent change in levels between baseline assessment and day after surgery|||Percent change in LL-37||Standard Deviation|Mean
2647855|NCT01690117|Secondary|Change From Baseline in Psychological Quality of Life on the German Version of the Mental Component Summary of the General Health Questionaire Short Form 12 (SF-12) at Month 6|SF-12 - mental component is a validated, self-reported instrument assessing psychological quality of live of the caregivers over the last four weeks time period. Possible scores range from 0 (lowest level of health) and 100 (highest level of health). Change = (Month 6 Score - Baseline score)|baseline and month 6|The SF-12 -mental component was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
2647856|NCT01690117|Secondary|Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 9|ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time. Possible scores range from 1 (no social support) to 25 (most possible social support). Change = (month 9 score - Baseline score)|baseline and month 9|The ESSI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
2647857|NCT01690117|Secondary|Change From Baseline in Social Support on the ENRICHED-Social-Support-Instrument (ESSI) (5-point Scale) at Month 6|ESSI is a validated, self-reported instrument assessing perceived social support of the caregivers over a undefined period of time. Possible scores range from 1 (no social support) to 25 (most possible social support). Change = (month 6 score - Baseline score)|baseline and month 6|The ESSI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
2647858|NCT01690117|Secondary|Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 9|PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period. Possible scores range from 0 (not mental ill) to 18 (worst possible mental illness). Change = (Month 9 Score - Baseline score)|baseline and month 9|The PHQ-4 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
2647859|NCT01690117|Secondary|Change From Baseline in Mental Health on the Patient Health Questionnaire - 4 Items (PHQ-4) (4-point Scale) at Month 6|PHQ-4 is a validated, self-reported Instrument assessing mental health over a 2 - week period. Possible scores range from 0 (not ill) to 18 (worst possible mental illness). Change = (Month 6 Score - Baseline score)|baseline and month 6|The PHQ-4 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
2647860|NCT01690117|Secondary|Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 9|PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period. Possible scores range from 0 (no somatization) to 30 (most possible somatization). Change = (Month 9 Score - Baseline score)|baseline and month 9|The PHQ - 15 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
2647861|NCT01690117|Secondary|Change From Baseline in Somatization on the Patient Health Questionaire - 15 Items (PHQ-15) - Module Somatization at Month 6|PHQ-15 is a validated, self-reported instrument assessing somatization over the last 4-weeks time period. Possible scores range from 0 (no somatization) to 30 (most possible somatization). Change = (Month 6 Score - Baseline score)|baseline and 6 month|The PHQ - 15 was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
2647862|NCT01690117|Primary|Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 9|The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time. Possible scores range from 0 (no burden) to 88 (highest possible burden). Change = (month 9 - baseline score).|baseline and month 9|The ZBI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
2647863|NCT01690117|Primary|Change From Baseline in Burden on the German Version of Zarit Caregiver Burden Interview (ZBI) (5-point Scale) at Month 6|The ZBI is a validated , self-reported instrument assessing burden of caregivers of people with dementia over a undefined period of time. Possible scores range from 0 (no burden) to 88 (highest possible burden). Change = (month 6 - baseline score).|baseline and month 6|The ZBI was compared between treatment groups using t-tests for independent samples on all randomised informal caregivers (intention-to-treat population). Several SPSS (Statistical Package for the Social Sciences ) - methods with missing value imputation were used, including expectation maximisation (EM) and multiple imputations.|||units on a scale||Standard Deviation|Mean
2647864|NCT01690052|Other Pre-specified|Adverse Events|Adverse events related to the combination and order of study medication will be measured|four weeks|||||||
2647941|NCT01689363|Secondary|Allergic Erythema Size in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The allergic erythema size is the greatest erythema diameter with accompanying localized itching measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized|||mm||Standard Deviation|Mean
2647865|NCT01690052|Primary|Change From Baseline in Saliva Production in ml.|"The primary outcome measure was the change of stimulated and non-stimulated saliva in ml from the baseline record.~At each appointment (weekly), participants will provide 2 saliva samples to measure their current salivary output. The first measurement will be obtained by having the patient spit as much as he or she could into a cup for five minutes. The amount of saliva in ml will be recorded.~The second measurement will be obtained in a similar manner with the addition of having the patient chew on a block of unflavored wax. Patients will complete weekly questionnaires to help determine which side-effects they experience as they take the medications."|4 weeks||||ml||Standard Deviation|Mean
2647866|NCT01690000|Secondary|Changes in Calcium Homeostasis|Calcium homeostasis will be analyzed through blood and urines samples|baseline, after 3, 6, 9 months, and end of study (after 12 months)|||||||
2647867|NCT01690000|Primary|Changes in Bone Mineral Density (BMD)|Effects of melatonin on BMD will be assessed through DXA-scans|baseline and end of study (after 12 months)||||percentage of change in BMD||Standard Error|Mean
2647868|NCT01689974|Primary|Response Rates of Ipilimumab Alone and of Ipilimumab With Radiation Therapy and to Estimate the Difference Between Response Rates With Ipilimumab Alone and Ipilimumab With Radiation Therapy|Eligible patients have metastatic melanoma with at least 2 measurable sites of disease. All patients with metastatic melanoma are eligible to be randomly assigned to Ipilimumab 3mg/kg IV over 90 minutes versus Ipilimumab 3 mg/kg IV over 90 minutes and radiotherapy to one of their measurable lesions, 6 Gy X5 (conformally or by IMRT/IGRT, to maximally spare normal tissue). For patients assigned to the Ipi/RT arm, Ipilimumab treatment starts after radiotherapy, with a dose given on day 4 from the first radiotherapy fraction and repeated on Days 25, 46 and 67. Patients will be re-imaged on Week 12 and evaluated for response (defined as an objective response of another metastatic site outside the radiation field). This response will be evaluated assessing clinical and CT responses in the non-irradiated measurable metastatic sites.|2 years|Study terminated because PI left institution. Data cannot be reported because 2 year data were not collected and were not analyzed.||||||
2647869|NCT01689909|Other Pre-specified|Actigraphy|This device measures arm motion over time.|8 weeks of treatment||2019-12-31|12/2019||||
2647870|NCT01689909|Other Pre-specified|Basis-32 - the Daily Living and Role Functioning (DLRF) Subscale|This is one of the subscales of the Basis 32. It is self-administered. This subscale has 7 items, each scored 0-4. The totals score is an average of the scores of these 7 items. Higher scores indicate more difficulty with daily living and role functioning.|8 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
2647871|NCT01689909|Secondary|Insomnia Severity Index (ISI)|The Insomnia Severity Index is self rated. It has 7 items, each scored 0-4. Therefore the range of scores is 0-28, with higher scores indicating worse insomnia|8 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
2647872|NCT01689909|Secondary|Hamilton Rating Scale for Depression (HAM-D)|This version of the Hamilton Rating Scale for Depression uses 24 items, with a possible total score ranging from 0-74, with higher scores indicating worse depression|8 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
2647873|NCT01689909|Secondary|Beck Hopelessness Scale (BHS)|The Beck Hopelessness Scale is self administered and has 20 'true/false' choices. Some items are reversed scored. The range of scores for the total is 0-20, with higher scores indicating greater hopelessness|8 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
2647874|NCT01689909|Secondary|Disturbing Dreams and Nightmares Severity Index (DDNSI)|This self-rated scale has 5 items, with asymmetric weighting of each item. The range of the total score is 0-37, with higher scores indicating worse nightmares|8 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
2647875|NCT01689909|Secondary|Dysfunctional Beliefs and Attitudes About Sleep|The Dysfunctional Beliefs and Attitudes About Sleep scale has 16 items and is self administered. Each item is scored 0-10. The total score is an average of the scores of the 16 items. Hence the range of the total score is also 0-10, with higher scores indicating greater dysfunctional beliefs about sleep|8 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
2647876|NCT01689909|Primary|Columbia Suicide Severity Rating Scale (C-SSRS): the Suicidal Ideation Scale|"The suicide ideation scale of the C-SSRS is rated 0-5, with 0 meaning no suicidal ideation, 1 meaning a wish t be dead, 2 meaning non-specific active suicidal thoughts, 3 meaning active suicidal ideation with any methods but no plan or intent, 4 meaning active suicidal ideation with some intent but no specific plan, and 5 meaning active suicidal ideation with intent and a specific plan"|8 weeks of treatment|all evaluable randomized participants|||units on a scale||Standard Error|Least Squares Mean
2647877|NCT01689909|Primary|Scale for Suicide Ideation Index (SSI)|This is the total score for the Scale for Suicide Ideation. It has 19 items, each scored 0-2, for a maximum of 38 points. Higher scores indicate worse suicidal ideation|Over 8 weeks of treatment||||units on a scale||Standard Error|Least Squares Mean
2647878|NCT01689857|Secondary|Satisfaction for Serviceability|Satisfaction for serviceability will be performed at the end of the 3 month when the treatment was completed by using Questionaire|the end of the 3 month of the treatment|||||||
2647879|NCT01689857|Primary|Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months|"Scar assessment will be performed at the beginning of the treatment, and at the end of the 3 month when the treatment is completed by using the Vancouver scar scale.VSS assesses 6 variables.~vascularity(range from normal(0 point) to purple(3point)~pigmentation(range from normal(0 point) to hyper-pigmentation(3point)~pliability(range from normal(0 point) to contracture(5point)~height (range from flat(0 point) to above 5mm(3point)~pain(range from none(0 point) to Require medication(2point)~itchiness(range from none(0 point) to Require medication(2point)~We assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition."|Baseline and 3 months|All participants for whom Vancouver Scar Scale measurements were recorded at Baseline and 3 months.|||units on a scale||Standard Deviation|Mean
2647880|NCT01689779|Other Pre-specified|Percent (%) Change in Pre-surgical LL-37 2 Weeks After Surgery|The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of changes in vitamin D status within 10-18 days after surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL-37.|Patients will be followed between the day of surgery and an average duration of 14 days after surgery|Data are presented as percent change in levels between baseline assessment and 2 weeks after surgery|||Percent change in LL-37||Standard Deviation|Mean
2647882|NCT01689779|Primary|Percent (%) Change in LL-37 5 Days Following Supplementation With 100,000 IU Cholecalciferol|3-7 days before surgery, patients will receive 100,000 IU of cholecalciferol (vs. placebo) during their pre-op assessment. They will also have their baseline vitamin D status measured during this initial visit. The main study outcome is to determine if 100,000 IU cholecalciferol can be given preoperatively to safely boost vitamin D status. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37|Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days|Data are presented as percent change in levels between baseline assessment and day of surgery|||percent change in LL-37||Standard Deviation|Mean
2647883|NCT01689779|Other Pre-specified|Percent (%) Change in Pre-surgical 25(OH)D 2 Weeks After Surgery|The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of changes in vitamin D status within 10-18 days after surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL-37.|Patients will be followed between the day of surgery and an average duration of 14 days after surgery|Data are presented as percent change in levels between baseline assessment and 2 weeks after surgery|||Percent change in 25(OH)D||Standard Deviation|Mean
2647884|NCT01689779|Secondary|Percent (%) Change in Pre-surgical 25(OH)D Within 24 Hours of Surgery|The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs. placebo) alters the natural course of short-term changes in vitamin D status following surgery. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37.|Patients will be followed between the day of surgery and 1 day after surgery|Data are presented as percent change in levels between baseline assessment and day after surgery|||Percent change in 25(OH)D||Standard Deviation|Mean
2647885|NCT01689779|Primary|Percent (%) Change in 25(OH)D 5 Days Following Supplementation With 100,000 IU Cholecalciferol|3-7 days before surgery, patients will receive 100,000 IU of cholecalciferol (vs. placebo) during their pre-op assessment. They will also have their baseline vitamin D status measured during this initial visit. The main study outcome is to determine if 100,000 IU cholecalciferol can be given preoperatively to safely boost vitamin D status. To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37|Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days|Data are presented as percent change in levels between baseline assessment and day of surgery|||percent change in 25(OH)D||Standard Deviation|Mean
2647886|NCT01689701|Secondary|Changes in Hs-CRP(High Sensitivity C-reactive Protein)|Hs-CRP(High Sensitivity C-reactive Protein) was measured in study visit 1(0 week) and visit 3(4 week).|4 weeks||||mg/L||Standard Deviation|Mean
2647887|NCT01689701|Secondary|Changes in Pepsinogen Ⅰ/Ⅱ Ratio|Pepsinogen Ⅰ/Ⅱ ratio was measured in study visit 1(0 week) and visit 3(4 week).|4 weeks||||ratio||Standard Deviation|Mean
2647888|NCT01689701|Secondary|Changes in PepsinogenⅡ|PepsinogenⅡ was measured in study visit 1(0 week) and visit 3(4 week).|4 weeks||||ng/ml||Standard Deviation|Mean
2647889|NCT01689701|Secondary|Changes in PepsinogenⅠ|PepsinogenⅠ was measured in study visit 1(0 week) and visit 3(4 week).|4 weeks||||ng/mL||Standard Deviation|Mean
2647890|NCT01689701|Secondary|Changes in Gastrin|Gastrin was measured in study visit 1(0 week) and visit 3(4 week).|4 weeks||||pg/ml||Standard Deviation|Mean
2647891|NCT01689701|Secondary|Changes in Subjects' Symptoms Total Score|"Subjects' symptoms total score(score 0-24) was measured in study visit 1(0 week) and visit 3(4 week).~The original index consists of 8 Questions. Individual question response is assigned a score of between 0 (none) to 3 (moderate) and summed to form a score ranging from 0 (best) to 24 (worst)."|4 weeks||||Units on a scale||Standard Deviation|Mean
2647892|NCT01689701|Primary|Changes in Score of Erosions|"Score of erosions(score 1-4) was measured in study visit 1(0 week) and visit 3(4 week).~Score of erosions is assigned a score of between 1 (Erosion = 0) to 4 (Erosion ≥ 6) and summed to form a score ranging from 1 (best) to 4 (worst)."|4 weeks||||Scores on a scale||Standard Deviation|Mean
2647893|NCT01689701|Primary|Changes in Erosions|Erosions was measured in study visit 1(0 week) and visit 3(4 week). Gastric erosion occurs when the mucous membrane lining the stomach becomes inflamed.|4 weeks||||erosions||Standard Deviation|Mean
2647894|NCT01689649|Secondary|Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures With or Without Previous Treatment||Month 4||||percentage of participants|||Number
2647895|NCT01689649|Secondary|General Clinical Assessment Before and After Treatment|The general clinical assessment is measured by clinical global impression scale. The scale is used to grade the participants as very good, good, fairly good, medium and Poor before (Visit 1) and after treatment (Visit 6).|Baseline (Day 0) and Month 4||||percentage of participants|||Number
2647896|NCT01689649|Secondary|Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Frequency (Less Than 4, 4 to 10 and Greater Than 10) After 16 Weeks||Month 4||||percentage of participants|||Number
2647897|NCT01689649|Secondary|Percentage of Participants With Greater Than or Equal to 50%, 75% and 100% Reduction in Seizures as Per the Seizure Types (Partial, Secondarily Generalized and Generalized Tonic and Clonic Siezures) After 16 Weeks||Month 1, Month 3 and Month 4||||percentage of participants|||Number
2647898|NCT01689649|Primary|Percentage of Seizure Free Participants During the Last 4 Months of Treatment||Month 1, Month 3 and Month 4||||percentage of participants|||Number
2647899|NCT01689649|Primary|Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 75%, During the Last 4 Months of Treatment||Month 1, Month 3 and Month 4||||percentage of participants|||Number
2647900|NCT01689649|Primary|Percentage of Participants Wiith Reduction in Number of Seizures Greater Than or Equal to 50%, During the Last 4 Months of Treatment||Month 1, Month 3 and Month 4||||percentage of participants|||Number
2647942|NCT01689363|Secondary|Observed Erythema Size in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The observed erythema size is the greatest erythema diameter measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized|||mm||Standard Deviation|Mean
2654701|NCT01633853|Primary|The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.|The blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected.|24 months||||pg/ml||Standard Deviation|Mean
2647901|NCT01689532|Secondary|Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Index Score at Weeks 16, 24 and 52|"Change from Baseline to end point in Euro Quality of life (Qol)-5 Dimension Questionnaire (EQ-5D). A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead."|Baseline, Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||units on a scale||Standard Deviation|Mean
2647902|NCT01689532|Secondary|Change From Baseline in EuroQol 5-Dimensional Questionnaire (EQ-5D) Visual Analog Scale (VAS) Score at Weeks 16, 24 and 52|The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant.|Baseline, Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||units on a scale||Standard Deviation|Mean
2647903|NCT01689532|Secondary|Change From Baseline in Physical Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52|The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary physical component score (PCS) is derived. Scales contributing most to the scoring of the SF-36 PCS include the PF, RP, BP and GH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary PCS score is also scaled from 0 to 100 with higher scores indicating better health.|Baseline, Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||units on a scale||Standard Deviation|Mean
2647904|NCT01689532|Secondary|Change From Baseline in Mental Component Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 16, 24 and 52|The SF-36 is a survey of participant health. It consists of 8 individual domains, which are weighted sums of the questions in their section. The 8 domains are: vitality (VT), physical functioning (PF), bodily pain (BP), general health (GH), Role-Physical (RP), Role-Emotional (RE), social functioning (SF) and mental health (MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary mental component score (MCS) is derived. Scales contributing most to the scoring of the SF-36 MCS include the VT, SF, RE and MH. Other domains not noted contribute to the scoring but to a lesser degree. The scoring is derived based on an algorithm that has been developed in a software provided by the developer. The summary MCS score is also scaled from 0 to 100 with higher scores indicating better health.|Baseline, Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||units on a scale||Standard Deviation|Mean
2647905|NCT01689532|Secondary|Change From Baseline in Duration of Morning Stiffness at Weeks 16 and 24|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). Negative values for this outcome measure represent improvement, i.e. shortening of duration of morning stiffness.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||minute||Standard Deviation|Mean
2647906|NCT01689532|Secondary|Area Under Curve (AUC) of Change From Baseline in HAQ-DI Score From Week 0 Through Week 24 and From Week 0 Through Week 52|HAQ-DI consisted of 20-question in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. AUC of change from baseline in HAQ-DI score is the AUC of change from baseline in HAQ-DI score versus the time. AUC was calculated based on the measurement (i.e., observed HAQ-DI score change from baseline) at scheduled visits using the trapezoidal rule. Functional status was determined as a cumulative measure of HAQ-DI over 1 year by using the AUC of the change from baseline in HAQ-DI score through week 52. Decreases in AUC of change from baseline in HAQ-DI indicate a greater average improvement in physical function over time.|Baseline, Weeks 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||units on a scale*week||Standard Deviation|Mean
2647907|NCT01689532|Secondary|Percentage of Participants Maintaining HAQ-DI Response|The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). HAQ-DI responders who maintain a change from baseline of > -0.22 in HAQ-DI score.|Baseline upto Week 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
2647908|NCT01689532|Secondary|Percentage of Participants Achieving HAQ-DI Response at Weeks 16 and 24|The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). HAQ-DI response was defined as change of > -0.22 from baseline in HAQ-DI score.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
2647909|NCT01689532|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 16 and 24|The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a participant has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living), each scored from 0 (no difficulty) to 3 (inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, at Week 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||units on a scale||Standard Deviation|Mean
2647910|NCT01689532|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Weeks 16 and 24|The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, physician's global assessments of disease activity, and CRP. The total score range is 0-86. Score interpretation: Remission SDAI <=3.3; Low Disease Activity SDAI >3.3 and <=11; Moderate Disease Activity SDAI >11 and <=26; High Disease Activity SDAI >26.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||units on a scale||Standard Deviation|Mean
2647911|NCT01689532|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Weeks 16 and 24|The CDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, and physician's global assessments of disease activity. The total score range is 0-76. Score interpretation: Remission <=2.8; Low Disease Activity CDAI > 2.8 and <=10; Moderate Disease Activity CDAI >10 and <=22; High Disease Activity CDAI > 22.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||units on a scale||Standard Deviation|Mean
2647912|NCT01689532|Secondary|Percentage of Participants With Boolean Based ACR/EULAR Remission at Weeks 16, 24 and 52|The Boolean based ACR/EULAR remission is achieved if all of the following 4 criteria at that visit are met: tender joint count (68 joints) <=1; swollen joint count (66 joints) <=1; CRP <=1 milligram per deciliter (mg/dL); and patient's global assessment of disease activity on visual analog scale (VAS) <=1 on a 0 to 10 scale.|At Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
2647913|NCT01689532|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Based ACR/European League Against Rheumatism (EULAR) Remission at Weeks 16, 24 and 52|The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity on VAS, physician's global assessments of disease activity on VAS, and CRP. SDAI-based ACR/EULAR remission is defined as a SDAI value of <=3.3 at the visit.|At Weeks 16, 24 and 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
2647914|NCT01689532|Secondary|Change From Baseline in DAS28 (CRP) Score at Weeks 16 and 24|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||units on a scale||Standard Deviation|Mean
2647915|NCT01689532|Secondary|Percentage of Participants Achieving DAS28 (CRP) Remission at Week 24|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (<) 2.6 at any study visit.|At Week 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
2647916|NCT01689532|Secondary|Percentage of Participants With Disease Activity Index Score 28 (CRP) Response at Weeks 16 and 24|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Good responders: improvement from baseline greater than (>) 1.2 with DAS28 less than or equal to (<=) 3.2; moderate responders: improvement from baseline >1.2 with DAS28 >3.2 to <=5.1 or improvement from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: improvement from baseline <=0.6 or improvement from baseline >0.6 and <=1.2 with DAS28 >5.1.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
2647927|NCT01689532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response|The ACR 50 Response is defined as >=50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and serum CRP.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
2647917|NCT01689532|Secondary|Percentage of Participants Who Achieved Major Clinical Response at Week 52|Major clinical response is achieving ACR 70 for 6 continuous months. The ACR 70 Response is defined as >=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS, (The scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP. Achievement of major clinical response reflects an enhanced level of therapeutic efficacy and sustained reduction of signs and symptoms of rheumatoid arthritis (RA).|Week 52|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
2647918|NCT01689532|Secondary|Percent Change From Baseline in C-Reactive Protein (CRP) at Weeks 16 and 24|Serum CRP is a marker of systemic inflammation. A negative percent change from baseline in CRP represents improvement.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percent change||Standard Deviation|Mean
2647919|NCT01689532|Secondary|Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Weeks 16 and 24|The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Here, 'n' signifies those participants who were evaluable for the specific timepoint.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percent change||Standard Deviation|Mean
2647920|NCT01689532|Secondary|Percent Change From Baseline in Physician's Global Assessment of Disease Activity at Weeks 16 and 24|Physician's Global Assessment of Disease Activity was assessed using the VAS on a scale of 0 (no arthritis activity) to 10 (extremely active arthritis).|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percent change||Standard Deviation|Mean
2647921|NCT01689532|Secondary|Percent Change From Baseline in Patient's Global Assessment of Disease Activity at Weeks 16 and 24|Participants rated their disease activity using the Visual Analog Scale (VAS) on a scale of 0 (very well) to 10 (very poor).|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percent change||Standard Deviation|Mean
2647922|NCT01689532|Secondary|Percent Change From Baseline in Patient's Assessment of Pain at Weeks 16 and 24|Participants assessed their average pain during the past week on a visual analogue scale (VAS). The scale ranged from 0 (no pain) to 10 (the worst possible pain).|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percent change||Standard Deviation|Mean
2647923|NCT01689532|Secondary|Percent Change From Baseline in Number of Tender Joints at Weeks 16 and 24|Sixty eight (68) joints were assessed for tenderness to determine the number of joints that were considered tender. A negative change from baseline in the tender joint count indicates improvement.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percent change||Standard Deviation|Mean
2647924|NCT01689532|Secondary|Percent Change From Baseline in Number of Swollen Joints at Weeks 16 and 24|Sixty six (66) joints were assessed for swelling by investigator to determine the number of joints that were considered swollen. A negative change from baseline in swollen joint count indicates improvement.|Baseline, Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percent change||Standard Deviation|Mean
2647925|NCT01689532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Response|The ACR 90 Response is defined as >=90 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=90 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
2647926|NCT01689532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response|The ACR 70 Response is defined as >=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
2647940|NCT01689363|Secondary|Local Itchiness Rate in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The local itchiness rate is the percentage of subjects that reported localized itching at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized|||percentage of participants|||Number
2647928|NCT01689532|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response|The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).|At Weeks 16 and 24|All participants randomly assigned to a treatment group were included in the efficacy analysis regardless of whether they received the assigned treatment.|||percentage of participants|||Number
2647929|NCT01689532|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|A TEAE was defined as an event that occurred in the treatment period during which it emerged (that is [i.e.] started or worsened in severity, relation, or other attribute), and even if the event continued to be present.|Baseline upto Week 68|Safety analyses set included all participants who received at least 1 (partial or complete) dose of the study drug.|||participants|||Number
2647930|NCT01689519|Secondary|Overall Survival (Final Analysis)|Overall survival was defined as the time from randomization until the date of death from any cause.|Baseline to the 28 August 2015 Overall Survival data cut-off (up to 2 years, 8 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received.|||Months||95% Confidence Interval|Median
2647931|NCT01689519|Secondary|Duration of Response|Duration of response was defined as the time from first occurrence of a documented confirmed objective response until the time of disease progression, as determined by investigator review of tumor assessments using Response Evaluation Criteria in Solid Tumors v1.1 or death from any cause during the study. Disease progression was defined as: (1) at least a 20% increase in the sum (the increase in the sum must be at least 5 mm) of diameters of target lesions, taking as reference the smallest sum during the study; (2) unequivocal progression of existing non-target lesions; or (3) the appearance of 1 or more new lesions.|Baseline to the 09 May 2014 data cut-off (up to 1 year, 4 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received. Only participants with an objective response were included in the analysis.|||Months||95% Confidence Interval|Median
2647932|NCT01689519|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors v1.1. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.|Baseline to the 09 May 2014 data cut-off (up to 1 year, 4 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received.|||Percentage of participants||95% Confidence Interval|Number
2647933|NCT01689519|Secondary|Overall Survival|Overall survival was defined as the time from randomization until the date of death from any cause.|Baseline to the 09 May 2014 data cut-off (up to 1 year, 4 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received.|||Months||95% Confidence Interval|Median
2647934|NCT01689519|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using Response Evaluation Criteria in Solid Tumors v1.1, or death from any cause, whichever came first. Disease progression was defined as: (1) at least a 20% increase in the sum (the increase in the sum must be at least 5 mm) of diameters of target lesions, taking as reference the smallest sum during the study; (2) unequivocal progression of existing non-target lesions; or (3) the appearance of 1 or more new lesions.|Baseline to the 09 May 2014 data cut-off (up to 1 year, 4 months)|Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received.|||Months||95% Confidence Interval|Median
2647935|NCT01689441|Secondary|Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) / Creatinine Ratio at 48 Hours|NGAL is a urinary marker of renal tubular injury. NGAL levels were normalized to the urinary creatinine concentration to account for the influence of dilution on biomarker concentrations.|48 hours|"The discrepancy in number of participants analyzed for this outcome vs. other outcomes is due to urine samples not being available in all participants"|||mg/mg||Inter-Quartile Range|Median
2647936|NCT01689441|Secondary|Plasma Interleukin-6 (IL-6) Levels at 48 Hours||48 hours||||pg/ml||Inter-Quartile Range|Median
2647937|NCT01689441|Primary|Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours||48 hours||||ng/ml||Inter-Quartile Range|Median
2647938|NCT01689363|Secondary|Allergic Wheal Size in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The allergic wheal size is the greatest wheal diameter with accompanying erythema and localized itching measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized|||mm||Standard Deviation|Mean
2647939|NCT01689363|Secondary|Erythema Responder Rate in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The erythema responder rate is the percentage of subjects that showed an erythema reaction at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized|||percentage of participants|||Number
2647988|NCT01688973|Secondary|Progression-free Survival (PFS)|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive without report of progression are censored at date of last contact.|30 months||||months||95% Confidence Interval|Median
2647943|NCT01689363|Secondary|Observed Wheal Size in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The observed wheal size is the greatest wheal diameter measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized|||mm||Standard Deviation|Mean
2647944|NCT01689363|Secondary|Erythema Responder Rate in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The erythema responder rate is the percentage of subjects that showed an erythema reaction at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments|||percentage of participants|||Number
2647945|NCT01689363|Secondary|Local Itchiness Rate in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The local itchiness rate is the percentage of subjects that reported localized itching at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments|||percentage of participants|||Number
2647946|NCT01689363|Secondary|Allergic Erythema Size in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The allergic erythema size is the greatest erythema diameter with accompanying localized itching measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments|||mm||Standard Deviation|Mean
2647947|NCT01689363|Secondary|Allergic Wheal Size in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The allergic wheal size is the greatest wheal diameter with accompanying erythema and localized itching measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments|||mm||Standard Deviation|Mean
2647948|NCT01689363|Secondary|Observed Erythema Size in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The observed erythema size is the greatest erythema diameter measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments|||mm||Standard Deviation|Mean
2647949|NCT01689363|Secondary|Observed Wheal Size in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. The observed wheal size is the greatest wheal diameter measured at the injection site(s) for a specific study drug injection.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments|||mm||Standard Deviation|Mean
2647950|NCT01689363|Primary|Positive Allergic Reaction to Amphadase® in the Intent-to-Treat Population (ITT)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. A positive reaction consisted of: a) reaction appearing within 30 minutes of drug placement; b) wheal (>8 mm) with or without pseudopods; c) reaction accompanying erythema; and d) reaction accompanying localized itching.|Up to 30 minutes after the final study drug injection|Subjects who have been randomized|||participants|||Number
2647951|NCT01689363|Primary|Positive Allergic Reaction to Amphadase® in the Per-Protocol Population (PPP)|Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. A positive reaction consisted of: a) reaction appearing within 30 minutes of drug placement; b) wheal (>8 mm) with or without pseudopods; c) reaction accompanying erythema; and d) reaction accompanying localized itching.|Up to 30 minutes after the final study drug injection|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments|||participants|||Number
2647952|NCT01689350|Secondary|Adverse Reaction ( Infection )|Flu-like symptoms, Upper respiratory tract infection，and the etc.|one month||||participants|||Number
2647953|NCT01689350|Primary|Adverse Reaction (Leucopenia)|The count of white cells < 4.0 × 10ˆ9/L in SLE patient who received CPA medication was considered as CPA-induced leucopenia.|one month||||participants|||Number
2648005|NCT01688882|Secondary|Number of Patients Investigator Global Assessment Score Over 12 Weeks|Investigator's Global Assessment (IGA) - (scale of 0 to 4, where 0=clear, 1=almost clear, 2=mild, 3=moderate and 4=severe)|Baseline (week 0), week 6 and week 12|Pharmacodynamics (PD) analysis set included all randomized patients.|||Number of participants|||Number
2647954|NCT01689337|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE is an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to Month 60|The safety analysis set included all participants who received at least 1 dose of trial drug.|||participants|||Number
2647955|NCT01689337|Secondary|Six-minute Walk Test|Six (6)-minute walk test is used to measure gait function and for pre- and post-operative evaluation in cartilage injury repair. Maximum comfortable distance (in meters) that a participant can walk in 6 minutes was to be reported.|Every 3 months up to 5 years beyond Month 6 post-MFx surgery|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
2647956|NCT01689337|Secondary|Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Score|The MOCART score is used to describe the constitution of the cartilage repair tissue and the surrounding structures.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
2647957|NCT01689337|Secondary|Volume of the Refilled Cartilage|Volume of the refilled cartilage was to be measured by MRI.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
2647958|NCT01689337|Secondary|Composition of the Refilled Cartilage Using T2 Mapping|The transverse relaxation time T2 mapping is an MRI technique that is able to evaluate collagen organization and orientation within cartilage. Composition of the refilled cartilage was to be reported.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
2647959|NCT01689337|Secondary|Change From Baseline in the Physician-reported Outcome Measure: Lysholm Knee Scale Score|The Lysholm knee scale is a physician-reported outcome measure to assess knee function after ligament injury. It is scaled from 0 to 100 with higher scores representing better function. Change from baseline in Lysholm knee scale score was to be calculated by the score at the specific time point minus the score at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
2647960|NCT01689337|Secondary|Change From Baseline in Participant-reported Outcome Measure: Lower Extremity Activity Scale (LEAS) Score|The LEAS is an 18-level single-question self-administered scale that has been validated as a clinical outcome measure for the assessment of participants' actual activity levels. The LEAS is scaled from 1 to 18, with 18 indicating levels of highest activity. Change from baseline in LEAS score was to be calculated by the score at the specific time point minus the score at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
2647961|NCT01689337|Secondary|Change From Baseline in Participant-reported Outcome Measure: Numeric Rating Scale (NRS) Score|Knee pain was to be rated by the participant using an 11-point NRS of pain intensity. The NRS is scaled from 0 (no pain) to 10 (worst possible pain). Change from baseline in NRS score was to be calculated by the score at the specific time point minus the score at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
2647962|NCT01689337|Secondary|Change From Baseline in Participant-reported Outcome Measure: Total KOOS Score, Three KOOS Sub-scores and Total KOOS Minus FSR Sub-score|The KOOS Version LK1.0 is a knee-specific self-administered questionnaire used to assess pain, function, quality of life, and ADL. It consists of 42 items grouped into 5 subscales: pain, other symptoms (including swelling, restricted range of motion, and mechanical symptoms), function in ADL, FSR, and impact on QOL (knee-related QOL, including awareness of the knee condition and changes in lifestyle). The subscales are scored separately; each yields a score between 0 and 100, with 0 representing extreme knee problems and 100 representing absence of problems. Total KOOS score is the average of all 5 subscale scores; ranging from 0 to 100; where 0 represents extreme knee problems and 100 represents absence of knee problems. Change from baseline in total KOOS score; other symptoms, knee-related QOL, and FSR sub-scores; and total KOOS minus FSR sub-score was to be calculated by the respective scores at the specific time point minus the scores at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
2647963|NCT01689337|Secondary|Change From Baseline in Participant-reported Outcome Measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-scores for Pain and Activities of Daily Living (ADL)|The KOOS Version LK1.0 is a knee-specific self-administered questionnaire used to assess pain, function, quality of life, and ADL. It consists of 42 items grouped into 5 subscales: pain, other symptoms (including swelling, restricted range of motion, and mechanical symptoms), function in ADL, function in sport and recreation (FSR), and impact on quality of life (QOL) (knee-related QOL, including awareness of the knee condition and changes in lifestyle). The subscales are scored separately; each yields a score between 0 and 100, with 0 representing extreme knee problems and 100 representing absence of problems. Total KOOS score is the average of all 5 subscale scores; ranging from 0 to 100; where 0 represents extreme knee problems and 100 represents absence of knee problems. Change from baseline in pain and ADL sub-scores was to be calculated by the respective scores at the specific time point minus the scores at baseline.|Every 6 months up to 5 years|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
2647964|NCT01689337|Secondary|Composition of the Refilled Cartilage Measured by dGEMRIC Using T1 Relaxation Time Beyond Month 6 Post-MFx Surgery|The dGEMRIC is an imaging technique that estimates the proteoglycan (and glycosaminoglycan) content of joint cartilage using spin-lattice relaxation time T1 after penetration of gadolinium contrast agent. Composition of the refilled cartilage was to be reported.|Every 6 months up to 5 years beyond 6 months post-MFx surgery|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
2648359|NCT01685684|Secondary|Rescue Medication Use by Dosage|Evaluation of the total amount of rescue medication used (by milligrams of dosage per day, dosage per week, and total dosage while on-study)|Randomization Baseline through Week 12||||milligrams||Standard Deviation|Mean
2647965|NCT01689337|Primary|Composition of the Refilled Cartilage Measured by Delayed Gadolinium-Enhanced Magnetic Resonance Imaging of Cartilage (dGEMRIC) Using T1 Relaxation Time at Month 6 Post-MFx Surgery|The dGEMRIC is an imaging technique that estimates the proteoglycan (and glycosaminoglycan) content of joint cartilage using spin-lattice relaxation time T1 after penetration of gadolinium contrast agent. Composition of the refilled cartilage was to be reported.|6 months post-MFx surgery|Efficacy analysis was not performed as only one participant was enrolled in the study. The study was terminated due to low recruitment.||||||
2647966|NCT01689324|Other Pre-specified|Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL®|"Solicited injection-site reactions: Pain, Redness, and Swelling. Grade 3: Pain, Significant, prevents daily activity; Redness and Swelling, >100 mm.~Solicited systemic reactions: Fever (Temperature); Headache, Malaise, and Myalgia. Grade 3: Fever, ≥ 39°C; Headache, Malaise and Myalgia, Significant, prevents daily activity."|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in the Safety Analysis Set|||Participants|||Number
2647967|NCT01689324|Other Pre-specified|Percentage of Participants With Booster Response to Pertussis Antigens, Pertactin and Fimbriae Following Vaccination With ADACEL®|Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)|Day 28 post-vaccination|Booster response to pertussis antigens were determined in the Immunology Analysis Set|||Percentage of Participants|||Number
2647968|NCT01689324|Other Pre-specified|Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL®||Day 0 (pre-vaccination) and Day 28 post-vaccination|Pre and post vaccination geometric mean concentrations to pertussis antibodies were determined in the Immunology Analysis Set|||Titers||95% Confidence Interval|Geometric Mean
2647969|NCT01689324|Other Pre-specified|Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL®||Day 0 (pre-vaccination) and Day 28 post-vaccination|Pre and post vaccination geometric mean concentrations to Diphtheria and Tetanus antigens were determined in the Immunology Analysis Set|||Titers||95% Confidence Interval|Geometric Mean
2647970|NCT01689324|Other Pre-specified|Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL®|Seroprotection was defined as the percentage of participants with antibody concentration of ≥1.0 IU/mL.|Day 0 (pre-vaccination) and day 28 post-vaccination|Pre- and post-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set|||Percentage of Participants|||Number
2647971|NCT01689324|Other Pre-specified|Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL®|Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.01 IU/mL.|Day 0 (pre-vaccination) and day 28 post-vaccination|Pre- and post-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set.|||Percentage of Participants|||Number
2647972|NCT01689324|Other Pre-specified|Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination With ADACEL®|Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL.|Day 0 pre-vaccination|Pre-vaccination seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set|||Percentage of Participants|||Number
2647973|NCT01689324|Primary|Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL®|Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)|Day 28 post-vaccination|Booster response to pertussis antigens were determined in the Immunology Analysis Set|||Percentage of Participants|||Number
2647974|NCT01689324|Primary|Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®|"Diphtheria booster response was defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.56 IU/mL.~Tetanus booster response was defined as a ≥ 4-fold rise in pre- to post- vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.7 IU/mL."|Day 28 post-vaccination|Booster response to diphtheria and tetanus antigens were determined in the Immunology Analysis Set|||Percentage of Participants|||Number
2647975|NCT01689324|Primary|Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®|Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination.|Day 28 post-vaccination|Seroprotection to diphtheria and tetanus antigens were determined in the Immunology Analysis Set|||Percentage of Participants|||Number
2647976|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter Vss for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Volume of distribution at steady state (Vss).|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)|||L||Geometric Coefficient of Variation|Geometric Mean
2647989|NCT01688973|Secondary|Frequency and Severity of Toxicities, Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|This study utilized the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting. Patients were evaluated every two weeks for the first eight weeks and then once every four weeks. If all protocol treatment is delayed more than three weeks, patients were removed from protocol treatment|Up to 3 years|All eligible patients who reported adverse events|||Participants|||Number
2647977|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameters CL and CLr for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Systemic clearence (CL) and renal clearance (CLr) on Day 1 after single infusion and at steady state after multiple infusion.|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)|||L/h||Geometric Coefficient of Variation|Geometric Mean
2647978|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter Cmax for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Maximum plasma concentration (Cmax µg/mL) on Day 1 after single infusion , maximum plasma concentration at steady state (Css,max µg/mL) after multiple infusion.|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2647979|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter Tmax for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) on Day 1 in Parts A, B and C|Time to Cmax (tmax)|Day 1|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)|||(h)||Full Range|Median
2647980|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter t1/2(h) for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Terminal half-life (t1/2), on Day 1 after single infusion and at steady state after multiple infusion.|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness. Placebo arms are not evaluated. Values shown where analysed (eg. not applicable for ATM alone in combination cohorts)|||h||Geometric Coefficient of Variation|Geometric Mean
2647981|NCT01689207|Secondary|PK- Plasma Pharmacokinetic Parameter AUC (ug*h/mL) for Aztreonam (ATM) and Avibactam (AVI) Alone and in Combination (ATM-AVI) in Parts A, B and C|Area under the plasma concentration-time curve from zero extrapolated to infinity (AUC µg*h/mL) or AUC(0-last) in Part A on Day 1 after single infusion, area under the plasma concentration-time curve at steady state after multiple infusion (AUCss µg*h/mL).|0 to 24 hours post-dose on Day 1 in Part A. 0 to 24 hours post-dose on Days 1, 2, 4 and 11 in Part B (varied intervals per cohort). 0 to 6 hours post-dose on Days 1, 4, 7 and 10 in Part C. Steady state measure on Day 11 in Part B or Day 10 in Part C|Pharmacokinetic analysis set. Please note, PK parameters have not been calculated where data is available in <3 subjects as this is considered to lack robustness.|||ug*h/mL||Geometric Coefficient of Variation|Geometric Mean
2647982|NCT01689207|Primary|Safety Profile - Number of Subjects With at Least 1 AE|from screening visit (Day -28) to 3 to 7 days post treatment period 3 (up to Day 22) in Part A, 3 to 7 days after receiving the final dose on Day 11 (days 14 to 18) in Part B, and 3 to 7 days after receiving the final dose on Day 10 (days 13 to 17) in Part C.|Informed consent (up to 28 days before first dose) to follow up period (max of 22 days after first dose for Part A, a max of 28 days after first dose in Part B, max 17 days in Part C)|Safety population|||Participants|||Number
2647983|NCT01689155|Other Pre-specified|Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Clinic Database.|Incidence rates for pre-specified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Pre-specified neurological conditions, hypersensitivity reactions, and new-onset autoimmune disease were selected for monitoring in the clinical database. Note: None of these events were identified in the clinic database.|Day 0 up to Day 75 post-vaccination|All participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.|||Events per 1,000 person-months|||Number
2647984|NCT01689155|Other Pre-specified|Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Hospital Database.|Incidence rates for identified events were to be calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination. Note: No events were identified in the hospital database.|Day 0 up to Day 75 post-vaccination|All participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.|||Events per 1,000 person-months|||Number
2647985|NCT01689155|Primary|Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database.|Incidence rates for each event were calculated as the number of events divided by person-time and expressed as events per 1,000 person-months in each comparison widow. The risk window was Days 0-30 following vaccination; the control window was Days 31-75 post-vaccination.|Day 0 up to Day 75 post-vaccination|Eligible participants who received Menactra vaccine during the study period and captured in the KPNC databases were included in the analysis.|||Events per 1,000 person-months|||Number
2647986|NCT01688973|Other Pre-specified|Number of Participants With EGFR Amplification, Deletion and No Alteration||Baseline|Tissue was only obtained from 35 patients. Exome of 16 patients were successfully sequenced using Agilent SureSelect probes.|||Participants|||Count of Participants
2647987|NCT01688973|Other Pre-specified|Number of Participants With c-MET Amplification, Deletion and No Alteration||Baseline|"Tissue was only obtained from 35 patients. Exome of 16 patients were successfully sequenced using Agilent SureSelect probes.~Arms were pooled due to no difference in response rate between the two arms"|||Participants|||Count of Participants
2647990|NCT01688973|Primary|Response Rate (Confirmed Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors|"Best Response is calculated from the sequence of objective statuses. CR: Two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration.~PR: Two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration, but not qualifying as CR.~Stable/no response: At least one objective status of stable/no response documented at least 6 weeks after registration and before progression or symptomatic deterioration, but not qualifying as anything else above.~Increasing disease: Objective status of progression within 12 weeks of registration, not qualifying as anything else above.~Symptomatic deterioration: Objective status of symptomatic deterioration within 12 weeks of registration, not qualifying as anything else above."|Up to 3 years||||Participants|||Count of Participants
2647991|NCT01688921|Secondary|Percentage of Subjects Who Received a PJ Stratis Injection Would Choose to Receive This Type of Injection Again||28 Days|Safety population|||Percent of Participants|||Number
2647992|NCT01688921|Secondary|Number of Subjects With Spontaneously Reported Adverse Events|"Subjects will be asked to report any other symptoms experienced in addition to the solicited immediate and vaccine reactogenicity events. Any other events reported will be tabulated as spontaneously reported adverse events."|28 days|The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS).|||participants with spontaneous AEs|||Number
2647993|NCT01688921|Secondary|Number of Subjects With Vaccine Reactogenicity Events|Vaccine reactogenicity will be collected on a patient-completed diary card during checkout from Day 0 and on the next six evenings post-vaccination. The following adverse events will be solicited on the diary card: pain at injection site, tenderness at injection site, redness where the injection is given; induration/swelling (lump) where the injection is given; bruising where the injection is given; itching where the injection is given; headache; tiredness/fatigue (asthenia, lethargy, malaise); general muscle ache (myalgia); chills; nausea; vomiting. Subjects will also record their oral temperature on the diary card each evening.|Day 0, 1, 2, 3, 4, 5, and 6|The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS). Eight subjects (624-616) in the PJ Stratis group and 16 (623-607) in the NS group did not return the 7-Day Diary Card.|||participants|||Number
2647994|NCT01688921|Secondary|Number of Subjects With Complaints Within 30 Minutes Following Vaccination||Within 30 minutes post-vaccination|The safety population included 1247 subjects (N=624 PJ Stratis, N=623 NS).|||participants|||Number
2647995|NCT01688921|Primary|Anti Influenza Type B Seroconversion|Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.|||Percent of Participants|||Number
2647996|NCT01688921|Primary|Anti Influenza Type A/H3N2 Seroconversion|Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.|28 days||||Percent of Participants|||Number
2647997|NCT01688921|Primary|Anti Influenza Type A/H1N1 Seroconversion|Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.|||Percent of Participants|||Number
2647998|NCT01688921|Primary|Anti Influenza Type B Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)|The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.|||Titers||Standard Deviation|Geometric Mean
2647999|NCT01688921|Primary|Anti Influenza Type A/H2N3 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)|The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for each antigen to not exceed 1.5 fold.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.|||Titers||Standard Deviation|Geometric Mean
2648000|NCT01688921|Primary|Anti Influenza Type A/H1N1 Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titer (GMT)|The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio(GMT with NS / GMT with PJ Stratis) for A/H1N1 antigen will not exceed 1.5 fold.|28 days|The immunogenicity analyses were conducted using data from subjects in the Immunogenicity Population.|||Titers||Standard Deviation|Geometric Mean
2648001|NCT01688895|Secondary|Sleep Disturbance PROMIS Scores|Sleep Subscales: Pain Interference, Depression, Physical Function, Fatigue, Anxiety, Sleep Disturbance, Satisfaction with Social Roles, each subscale scored from 0-100 with higher score indicating more symptoms affecting sleep.|baseline|*Only those subjects who completed the PROMIS was included|||score on a scale||Standard Deviation|Mean
2648002|NCT01688895|Primary|EPP-Specific Tool|Each item was scored from 0-3 on a Likert scale. There are 2 domains: S=disease severity and Q=QoL. Total scale for each domain transferred to 0-100 scale. Higher scores for the S domain reflect lower severity, and higher satisfaction/QoL for the Q domain. Total Score from 0-100, with higher score indicating higher quality of life.|1 week|Data only for those who completed instrument included. A protocol modification to add the EPP-Specific tool was done after study initiation, therefore not all subjects received all tools.|||units on a scale||Standard Deviation|Mean
2648003|NCT01688895|Primary|Illness Perception Questionnaire Revised (IPQR)|"Each item is scored on a likert scale from 1 (strongly disagree) to 5 (strongly agree). Items within each domain were totaled for final domain scores.~Seven domains - Timeline (score 5-25), Consequences (score 6-30), Personal Control (score 6-30), Treatment Control (score 3-15), Illness Coherence (score 5-25), Timeline-Cyclical (score 4-20), and Emotional Representations (score 6-30). A modified version without the identity component was used as it was not applicable in EPP.~Higher scores domains indicate overall strong beliefs that the disease is chronic and has a negative impact."|1 week|Data only for those who completed instrument included. A protocol modification to add the IPQR tool was done after study initiation, therefore not all subjects received all tools.|||score on a scale||Standard Deviation|Mean
2648006|NCT01688882|Secondary|Response Based on Clinical Global Assessment of Change CGA-C Score at 6 Weeks|"Clinical Global Assessment of Change (CGA-C) responder rate was the responder rate at 6 weeks based on the CGA-C score in bullous pemphigoid (BP).~A patient with a CGA-C score of 3 or 4 indicating marked improvement from baseline at 6 weeks was considered a responder. The CGA-C is an investigator assessment of change from baseline and is scored as follows: -4 = Very marked worsening (100% worsening); -3 = Marked worsening (67-99% worsening); -2 = Moderate worsening (34-66% worsening); -1 = Slight worsening (1-33% worsening); 1= Slight improvement (1-33% improvement); 2 = Moderate improvement (34-66% improvement); 3 = Marked improvement (67-99% improvement); 4 = Complete clearance (100% improvement)"|6 weeks|Pharmacodynamics (PD) analysis set included all randomized patients.|||number of participants|||Number
2648007|NCT01688882|Primary|Number of Patients That Had a Clinical Global Assessment of Change (CGA-C) Responder Rate by Week 12|"Clinical Global Assessment of Change (CGA-C) responder rate was the responder rate at 12 weeks based on the CGA-C in bullous pemphigoid (BP).~A patient with a CGA-C score of 3 or 4 indicating 'at least marked improvement from baseline' at 12 weeks was considered a responder. The CGA-C is an investigator assessment of change from baseline and is scored as follows: -4 = Very marked worsening (100% worsening); -3 = Marked worsening (67-99% worsening); -2 = Moderate worsening (34-66% worsening); -1 = Slight worsening (1-33% worsening); 1= Slight improvement (1-33% improvement); 2 = Moderate improvement (34-66% improvement); 3 = Marked improvement (67-99% improvement); 4 = Complete clearance (100% improvement)"|12 weeks|Pharmacodynamics (PD) analysis set included all randomized patients.|||number of participants|||Number
2648008|NCT01688856|Secondary|Change in Arm Motor Abilities Test (AMAT) at 6 Months Post-Treatment|"The Arm Motor Abilities Test (AMAT) is an assessment of the participant's ability to do 9 standardized upper limb tasks. Each task is composed of 1 to 3 component tasks, each of which is rated on an ordinal scale of 0 to 5. The final score is the average of all component task scores across all 9 compound tasks.~Min=0; Max=5. Higher scores mean a better outcome."|2 timepoints: prior to treatment, 6 months post-treatment||||units on a scale||95% Confidence Interval|Least Squares Mean
2648009|NCT01688856|Secondary|Change in Stroke Upper Limb Capacity Scale (SULCS) at 6 Months Post-Treatment|"Stroke Upper Limb Capacity Scale (SULCS) is a 10-item test in which participants are given a score of 0 or 1 on their performance of tasks requiring varying degrees of upper limb capacity.~Min=0; Max=10. Higher scores mean a better outcome."|2 timepoints: prior to treatment, 6 months post-treatment||||units on a scale||95% Confidence Interval|Least Squares Mean
2648010|NCT01688856|Secondary|Change in Upper Extremity Fugl-Meyer (UEFM) Score at 6 Months Post-Treatment|"The Upper Extremity Fugl-Meyer (UEFM) is an assessment of motor impairment of the upper limb in which the participant is asked to make specific movements of the arm, forearm, wrist, and hand. Each movement is scored 0, 1, or 2 and the subscores are summed.~Min=0; Max=66. Higher scores mean a better outcome."|2 timepoints: prior to treatment, 6 months post-treatment||||units on a scale||95% Confidence Interval|Least Squares Mean
2648011|NCT01688856|Secondary|Change in Reachable Workspace (RW) at 6 Months Post-Treatment|Reachable Workspace (RW) is the area (cm^2) traced out when reaching for a target moving in a circular path just outside the reach of the participant.|2 timepoints: prior to treatment, 6 months post-treatment||||squared centimeters||95% Confidence Interval|Least Squares Mean
2648012|NCT01688856|Primary|Change in Box and Block Test (BBT) Score at 6 Months Post-Treatment|The BBT counts how many blocks a participant can pick up, move over a barrier, and release in 60 seconds. Higher scores mean a better outcome.|2 timepoints: prior to treatment, 6 months post-treatment||||blocks||95% Confidence Interval|Least Squares Mean
2648013|NCT01688843|Other Pre-specified|Ancillary Safety|Lead-related complication-free rate|From 3 to 60 months post-implant|Leads eligible for endpoint analyses|||percentage of leads complication-free|Leads|95% Confidence Interval|Number
2648014|NCT01688843|Primary|Effectiveness 3|Clinically acceptable pacing impedance between 300 Ω and 1300 Ω|Lead implant through 3 month follow up||||Ω|Implant/Attempted Leads|95% Confidence Interval|Mean
2648015|NCT01688843|Primary|Effectiveness 2(Right Ventricle)|R-wave sensed amplitude at three months post-implant > 5 mV|Lead implant through 3 month follow up||||mV|Implant/Attempted Leads|95% Confidence Interval|Mean
2648016|NCT01688843|Primary|Effectiveness 2(Right Atrium)|P-wave sensed amplitude at three months post-implant > 1.5 mV|Lead implant through 3 month follow up||||mV|Implant/Attempted Leads|95% Confidence Interval|Mean
2648017|NCT01688843|Primary|Effectiveness 1|The bipolar pacing threshold at 0.5 ms at three months post-implant < 1.5 V|Lead implant through 3 month follow up||||volts|Implant/Attempted Leads|95% Confidence Interval|Mean
2648018|NCT01688843|Primary|Safety 3 - Hazard Rate of Lead-Related Complications|Hazard rate of lead-related complications over time. This endpoint will use the Weibull distribution to estimate the hazard over time by evaluating the Weibull shape parameter. A Weibull shape greater than one (>1), equal to one (=1) and less than one (<1) indicates accelerating, constant, and decelerating hazard of lead-related complications over time, respectively. This endpoint requires the Weibull shape estimate to be less than 1.|Implant through 12 months (including available data beyond 12 months)|Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who met inclusion/exclusion criteria and were implanted or attempted with INGEVITY lead(s). Of the 1060 enrolled participants, 24 did not meet these criteria and were excluded from the analysis.|||hazard rate of lead-related complication|Leads Implanted/Attempted|95% Confidence Interval|Number
2648019|NCT01688843|Primary|Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months)|Lead-related complication-free rate from three months post-implant through twelve months post implant, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 94%.|3 months through 12 months post implant|Leads still in service and implanted in actively followed participants at 92 days were included in analysis.|||percentage of leads complication-free|Implant/Attempted Leads|95% Confidence Interval|Number
2648043|NCT01688635|Primary|Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2963016 and US-Approved Lantus||30 minutes predose up to 24 hours postdose in all treatment periods|Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate Cmax. Participants were analyzed based on the treatment they received|||picomoles/liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
2648020|NCT01688843|Primary|Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)|Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 91.4%|Lead implant through 3 month follow up|Final lead implanted or attempted during initial procedure per chamber was used for analysis. Analysis leads were from participants who met inclusion/exclusion criteria and were implanted or attempted with INGEVITY lead(s). Of the 1060 enrolled participants, 24 did not meet these criteria and were excluded from the analysis.|||percentage of leads complication-free|Implant/Attempted Leads|95% Confidence Interval|Number
2648021|NCT01688830|Secondary|AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 3 of the Study|"AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).~Ratio of above baseline AUEC(2−12) on Day 4 to above baseline AUEC(2−12) on Day 3 is presented.~This endpoint was determined for Activated Partial Thromboplastin time (aPTT) and Dithiothreitol (dTT)"|2hours-12 hours|"Pharmacodynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and~1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD."|||ratio||Standard Deviation|Mean
2648022|NCT01688830|Secondary|AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 2 of the Study|"AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).~Ratio of above baseline AUEC(2−12) on Day 4 to above baseline AUEC(2−12) on Day 3 is presented.~This endpoint was determined for Activated Partial Thromboplastin time (aPTT), Dithiothreitol (dTT), Thrombin time (TT) and Ecarin clotting time (ECT)"|2hours-12 hours|"Pharmacodynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and~1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD."|||ratio||Standard Deviation|Mean
2648023|NCT01688830|Secondary|AUCt1-t2,ss (Area Under the Concentration-time Curve for the Unbound Sum Dabigatran in Plasma From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4|AUC(2-12),ss ((area under the concentration-time curve for the idarucizumab in plasma from time point 2 to 12 h )) on Day 3 and Day 4|2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2648024|NCT01688830|Secondary|C1.92,ss, C2,ss, C2.5,ss, C6,ss, and C12,ss (Concentration of the Unbound Sum Dabigatran in Plasma at Steady State)|"Concentrations of unbound sum dabigatran in plasma after 1.92 to 12 h, at steady state of dabigatran, on Day 4 are presented.~The endpoint refers to unbound sum dabigatran at several time points. The intended pharmacodynamic effect of idarucizumab is to reduce the concentration of this measure to levels below the lower limit of quantification (BLQ). BLQ values are not considered in the calculation of descriptive statistics; and therefore bias the result. This is the reason for applying the 2/3 rule to obtain reliable results. 2/3 rule states that, Statistics of PK parameters are only estimated when at least 2/3 of the data are evaluable."|1.92 hours (h), 2 h, 2.5 h, 6 h and 12 h on Day 4|"Pharmadynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and~1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2648025|NCT01688830|Secondary|Aet1-t2,ss (Amount of Dabigatran Etexilate Eliminated in Urine From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4 for Sum Dabigatran|"Aet1-t2,ss (amount of dabigatran etexilate eliminated in urine from time point t1 to time point t2, at steady state) on Day 3 and Day 4~Ae(0-12h,ss) of sum dabigatran"|Intervals 0-2, 2-6, 6-10, 10-12 hours on Day 3 post dabigatran treatment and -2 to -0:05, -0:05 to 4, 4-8, 8-10, 10-12, 12-24, 24-48, 48-72 on Day 4 post Idarucizumab treatment|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)|||μg||Geometric Coefficient of Variation|Geometric Mean
2648026|NCT01688830|Primary|Number of Subjects With Drug Related Adverse Events (AE)|Frequency of subjects with related adverse events (AE) by treatment|AEs occurring until end of follow-up (Up to 3 months after last drug administration)|Treated set|||participants|||Number
2648027|NCT01688830|Secondary|Aet1-t2 (Amount of Idarucizumab Eliminated in Urine From Time Point t1 to Time Point t2)|"Aet1-t2 (amount of idarucizumab eliminated in urine from time point t1 to time point t2)~Ae(0-7h) is presented for dose groups with 1 h infusion and Ae(0-4h) is presented for dose groups with 5 min infusion."|Up to 7 hours|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)|||μmol||Geometric Coefficient of Variation|Geometric Mean
2648028|NCT01688830|Secondary|AUC0-inf (Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity) for Idarucizumab|AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity) for idarucizumab|-2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2648029|NCT01688830|Secondary|Tmax (Time From Dosing to Maximum Measured Concentration) for Idarucizumab|tmax (time from dosing to maximum measured concentration) for idarucizumab|-2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h|PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)|||hours||Full Range|Median
2648030|NCT01688830|Secondary|Cmax (Maximum Measured Concentration) for Idarucizumab|Cmax (maximum measured concentration) for idarucizumab|-2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h|Pharmacokinetic set (PKS) comprises of all subjects (with evaluable observations) in the TS who provided at least 1 PK endpoint and had no important protocol violations relevant to the evaluation of PK and additionally for Part 2 and 3 had no emesis with onset at or before twice the median tmax of dabigatran.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2654702|NCT01633853|Primary|The Blood Levels of Phosphorus at the 24th Month of Following up.|The blood levels of phosphorus at the 24th month of following up will be detected.|24 months||||mmol/L||Standard Deviation|Mean
2648031|NCT01688739|Secondary|Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow|"Inhibition of capsaicin-induced dermal blood flow (DBF) by erenumab was used to measure calcitonin gene-related peptide (CGRP) receptor antagonism. Capsaicin was applied at 2 sites on the volar surface of the participants' left or right forearms and a control mixture was applied to 1 site on the volar surface of either the participants' left or right forearm. Dermal blood flow was assessed by laser Doppler perfusion imaging and was done immediately before ('baseline') and 0.5 hours post-capsaicin on the surface of these 3 sites.~Data reported are the least square geometric mean ratios for the post-capsaicin dermal blood flow to pre-capsaicin dermal blood flow.~According to the protocol, not all cohorts had dermal blood flow measurements at all time points."|Days 4, 15, 29, 43, 64, 85, 99, 127, and end of study (defined as day 43 for the 1 mg, 7 mg and 21 mg erenumab cohorts, day 99 for the 70 mg erenumab cohort, day 127 for the 140 mg erenumab cohorts and day 155 for the 210 mg erenumab cohort).|All participants for whom at least one post-dose capsaicin response measure was recorded.|||ratio||Standard Error|Geometric Least Squares Mean
2648032|NCT01688739|Secondary|Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of Erenumab||Predose to 155 days postdose|All participants who received erenumab|||days*µg/mL||Standard Deviation|Mean
2648033|NCT01688739|Secondary|Area Under the Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Erenumab||Predose to 155 days postdose|All participants who received erenumab|||days*µg/mL||Standard Deviation|Mean
2648034|NCT01688739|Secondary|Time to Maximum Observed Concentration (Tmax) of Erenumab||Predose to 155 days postdose|All participants who received erenumab|||days||Full Range|Median
2648035|NCT01688739|Secondary|Maximum Observed Concentration (Cmax) of Erenumab||Predose to 155 days postdose|All participants who received erenumab|||µg/mL||Standard Deviation|Mean
2648036|NCT01688739|Primary|Number of Participants Who Developed Anti-erenumab Antibodies|Participants who had a negative or no result at baseline and were antibody positive postbaseline. Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies.|Baseline and up to 155 days postdose|All participants who received study drug|||Participants|||Count of Participants
2648037|NCT01688739|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events.~Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug.~A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:~fatal~life-threatening (places the subject at immediate risk of death)~requires in-patient hospitalization or prolongation of existing hospitalization~results in persistent or significant disability/incapacity~congenital anomaly/birth defect~other medically important serious event."|From the initial dose of study drug up to 155 days.|All participants who received study drug.|||Participants|||Count of Participants
2648038|NCT01688726|Secondary|Non Invasive Tear Film Break-up-time (NIBUT)|NIBUT was measured prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation. The time elapsed between eye opening after a blink and the appearance of the first dark spot within the tear film as observed with a specialized illumination source was recorded. A higher number represents a lengthening in the tear film break up time and greater perceived ocular comfort.|Month 1|This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment. Here, n represents the number of participants with non-missing values at the specific time point for each arm group, respectively.|||seconds||Standard Deviation|Mean
2648039|NCT01688726|Secondary|High Contrast logMAR Time Controlled Visual Acuity (TCVA)|TCVA (functional visual performance) was measured with both eyes together under controlled lighting, contrast and temporal conditions using the OTG computerized vision testing system prior to eyedrop instillation (baseline) and at 60, 90, and 120 minutes post eyedrop instillation with the subject's up-to-date vision correction in place. TCVA is measured in logarithm of the minimum angle of resolution (logMAR), with logMAR acuity of 0.0 considered normal distance eyesight. A negative logMAR value denotes better visual acuity.|Month 1|This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment.|||logMAR||Standard Deviation|Mean
2648040|NCT01688726|Primary|Mean Bulbar Conjunctival Staining|The conjunctival staining present in the bulbar area was evaluated 120 minutes post eyedrop instillation using a slit lamp with digital image capture and lissamine green strips. Staining coverage as a percentage of the exposed bulbar conjunctiva is reported. A lower percentage in staining area represents a better outcome.|Month 1|This analysis population includes all randomized participants with at least 1 evaluable post-treatment efficacy assessment.|||percentage of staining||Standard Deviation|Mean
2648041|NCT01688635|Secondary|Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure|Gtot was the total glucose infusion over the clamp duration and was used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations were held constant after the administration of LY2963016 or US-approved Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.|30 minutes predose up to 24 hours postdose in all treatment periods|Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data to calculate Gtot. Participants were analyzed based on the treatment they received.|||milligrams/kilogram (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
2648042|NCT01688635|Secondary|Maximum Glucose Infusion Rate (Rmax)|Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain target blood glucose level and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or US-approved Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.|30 minutes predose up to 24 hours postdose in all treatment periods|Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable pharmacodynamic data to calculate Rmax. Participants were analyzed based on the treatment they received.|||milligrams/kilograms/minute (mg/kg/min)||Geometric Coefficient of Variation|Geometric Mean
2648044|NCT01688635|Primary|Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2963016 and US-Approved Lantus|The AUC from time 0 to 24 hours (AUC0-24) of LY2963016 and US-Approved Lantus was measured.|30 minutes predose up to 24 hours postdose in all treatment periods|Full analysis set (FAS): All randomized participants who received at least 1 dose of study drug and had evaluable PK data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.|||picomoles*hour/liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2648045|NCT01688609|Secondary|Number of Participants With Treatment-Related Toxicities||Up to 12 weeks after completion of study treatment||||participants|||Number
2648046|NCT01688609|Secondary|EGFR-mutation Status of Tumors and Changes in the Ratio of Phosphorylated to Nonphosphorylated HER2, EGFR, ERK, Akt, and the Ki67 and TUNEL Indices Before and After Treatment|"The EGFR mutation status will be a binary variable (yes vs. no), and the phosphorylation status of HER2 and EGFR will be a ratio variable (0-100%). The CART method to identify cut-off points for the phosphorylation ratio of molecules of interest will be used, such that ratios above the cut-off point will be considered high phosphorylation and ratios below the cut-off point will be considered low phosphorylation."|From baseline to 24 weeks|The study was not able to determine the cut off value of total and phorylated RTK ratio. Assays were not reliable. Data of EGFR mutations were not collected.||||||
2648047|NCT01688609|Secondary|Cellular Response Rate, Defined as Patients With an Epithelial Phenotype Having Eradication of CTCs; Patients With a Mesenchymal Phenotype Having Eradication of Tumor Cells; Patients With a Mesenchymal Phenotype Converting to an Epithelial Phenotype|Cellular response will be documented and calculated for rate in all patients.|Up to 18 weeks||||participants|||Number
2648048|NCT01688609|Primary|Number of Participants With Pathological Complete Response (pCR)|The point estimate of the pCR rate will be calculated for all patients. pCR is defined as the abscence of invasive cancer in the breast and regional lymph nodes following neoadjuvant chemotherapy.|Up to 12 weeks||||Participants|||Count of Participants
2648049|NCT01688609|Primary|Expression of ALDH1 and CD44v Change in the Binary Biomarkers From Baseline to 6 Weeks and 18 Weeks|For biomarkers ALDH1 and CD44v, the change in the proportions of CD44v-positive (CD44v+) tumor cells and ALDH1-positive (ALDH1+) tumor cells in tumor tissue from baseline to 6 weeks and 18 weeks time points were determined for each patient. For biomarker change, changes in the binary biomarkers between time points were assessed using McNemar's test in all patients and separately in patients with and without pCR.|From baseline to 18 weeks||||Participants|||Count of Participants
2648050|NCT01688596|Other Pre-specified|Primary Surgical Finding|The primary intra-operative finding found during surgery, defined as one of the following: endometriosis, pelvic adhesive disease, leiomyoma, or other.|Surgical findings will be measured on the day of surgery after completing the procedure.||||Participants|||Count of Participants
2648051|NCT01688596|Secondary|Histopathologic Diagnosis|Histopathologic diagnosis describes the findings seen on tissue pathology and microscopy and is defined as one of the following: endometriosis, leiomyoma, adenomyosis, or other.|Histopathologic diagnosis will be measured on the day of surgery after completing the procedure.||||Participants|||Count of Participants
2648052|NCT01688596|Secondary|Length of Hospital Stay >= 24 Hours|Length of hospital stay will be measured on the day of surgery after completing the procedure to when the patient is discharged from the hospital. Length of stay will be categorized as less than 24 hours vs. greater than or equal to 24 hours.|from time surgery completed to time patient discharged||||Participants|||Count of Participants
2648053|NCT01688596|Secondary|Operating Time|Operating time measured in minutes|start to end of patient's surgery||||minutes||Standard Deviation|Mean
2648054|NCT01688596|Secondary|Surgical Complications|Intraoperative complications include injury to bowel, bladder, blood vessels, nerves and hemorrhage. Perioperative complications include urinary tract infections, urinary retention, ileus, myocardial infarction, atrial fibrillation, pulmonary edema, atelectasis, pneumonia, renal and cerebrovascular morbidity, thromboembolic complications (DVT and PE). Postoperative complications include pulmonary, renal, and cerebrovascular morbidity, wound and vaginal vault complications (infection, separation, and dehiscence), septicemia, thromboembolic events, and re-operation.|From date of randomization up to 12 months||||Participants|||Count of Participants
2648055|NCT01688596|Secondary|Estimated Blood Loss > 200 mL|Estimated blood loss will be measured in (mL) on the day of surgery after completing the procedure. Blood loss will be categorized as >200 mL vs. <= 200 mL.|day of surgery after procedure completion||||Participants|||Count of Participants
2648056|NCT01688596|Primary|Postoperative Pain Score|"Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 24 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to no pain and 10 equates to unable to move."|24 hours||||units on a scale||Standard Deviation|Mean
2648057|NCT01688596|Primary|Postoperative Pain Score|"Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 6 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to no pain and 10 equates to unable to move."|6 hours||||units on a scale||Standard Deviation|Mean
2648058|NCT01688596|Primary|Postoperative Pain Score Evaluated by Numerical Rating Scale (NRS)|"Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 4 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to no pain and 10 equates to unable to move."|4 hours||||units on a scale||Standard Deviation|Mean
2648059|NCT01688466|Secondary|Toxicity|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|50 months and 20 days||||Participants|||Count of Participants
2648060|NCT01688466|Primary|Overall Response at 6 Months|Overall response was assessed by the National Institutes of Health (NIH) Chronic Graft-Versus Host Disease (cGVHD) Response criteria. Complete response (CR) is complete resolution in all signs and symptoms at all affected organs or tissues. Partial response (PR) is improvement in ≥ 1 organ or tissue with no progression in any other affected organ or tissue. Response < PR is a change towards improvement from the pre-treatment baseline but not meeting the criteria for CR or PR. Stable disease (SD) is no change in cGVHD. Flare is exacerbation of cGVHD manifestations during withdrawal of immunosuppressive therapy which do not exceed those at the beginning of the trial and improves after reinstatement of previous treatment. Progressive disease (PD) is failure of therapy to control cGVHD . Mixed response (improvement in some organs but worsening in others) will be categorized as progressive disease.|6 months||||Participants|||Count of Participants
2648061|NCT01688336|Other Pre-specified|Correlation of Tumor Markers (Ca19-9, CEA) With Outcomes (RR, DCR, PFS, and OS).|Tumor markers (Ca19-9, CEA) will be measured at baseline, every eight weeks and at end of treatment, and will be correlated with outcomes resectability response (RR),disease control rate (DCR), progression free survival (PFS) and overall survival (OS).|Up to 3 years|Data were not collected||||||
2648062|NCT01688336|Secondary|Rate of Resectability (RR)|Rate of resectability will be evaluated by determining the percentage of patients who were initially deemed to have ULA or borderline resectable (BR) disease and, following any period of treatment, were subsequently deemed to have resectable disease and undergo surgical resection. The denominator will reflect all patients with ULA or BR disease.|Up to 3 years||||percentage of patients||95% Confidence Interval|Number
2648063|NCT01688336|Secondary|Disease Control Rate (DCR)|Disease control rate will be measured by the percentage of patients with responses (CR) and partial responses (PR) and stable disease (SD), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); Complete Response (CR), Disappearance of all target lesions.|Up to 3 years||||percentage of patients||95% Confidence Interval|Number
2648064|NCT01688336|Secondary|Objective Response Rate|"All patients who have received at least one cycle of treatment will be evaluated. Disease will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) for target lesions and assessed by CT and/or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.~Patients who drop out of the study prior to disease evaluation will not be evaluable for response unless the patient undergoes radiologic evaluation or their disease progresses clinically."|Up to 3 years||||percentage of patients||95% Confidence Interval|Number
2648065|NCT01688336|Secondary|Progression Free Survival (PFS)|Progression free survival will be measured from D1 of treatment until evidence of tumor progression (including clinical deterioration related to the underlying pancreatic cancer, as assessed by the investigator) or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are lost to follow-up will be censored|the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years||||Months||95% Confidence Interval|Median
2648066|NCT01688336|Secondary|Overall Survival for Borderline Resectable Patients|All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the outcome of overall survival (OS)|Up to 3 years||||Months||95% Confidence Interval|Median
2648067|NCT01688336|Primary|Median Overall Survival (OS) of FOLFIRINOX in Patients With Unresectable Locally Advanced (ULA) Pancreatic Cancer|All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the primary outcome of overall survival (OS).|Up to 3 years|Patients with unresectable locally advanced pancreatic cancer.|||months||95% Confidence Interval|Median
2648068|NCT01688310|Other Pre-specified|Adverse Events|Intraoperative and post-operative adverse events, such as bleeding, hematoma, and infection|1 yr||||participants|||Number
2648069|NCT01688310|Secondary|Cosmetic Result|Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance).|Within 6 weeks after surgery||||participants|||Number
2648070|NCT01688310|Secondary|Overall Patient Satisfaction|Patient satisfaction evaluated with patient satisfaction questionnaire using five point Likert scale.|Within 6 weeks after surgery||||participants|||Number
2648071|NCT01688310|Secondary|Pain Experienced|Pain experienced during and after the procedure using Pain Questionnaire with 10 point pain scale (0 signifies no pain and 10 signifies maximal pain)|2 days after surgery||||units on 10 point pain scale||Standard Deviation|Mean
2648072|NCT01688310|Secondary|Direct Costs|the cost of labor, supplies and equipment|Within 6 weeks after surgery|||||||
2648073|NCT01688310|Secondary|Time Required for Healing|Time required for healing|Within 6 weeks after surgery||||percentage of participants|||Number
2648074|NCT01688310|Secondary|Difficulty in Learning and Performing Technique|"Evaluated by doctor survey, 5 point Likert scale:~Gomco technique is much easier~Gomco technique is easier~Neutral~Open surgical technique is easier~Open surgical technique is much easier"|1 year||||units on Likert scale||Full Range|Median
2648075|NCT01688310|Primary|Intraoperative Duration|Time it takes for procedure from first manipulation of tissue under local anesthesia to dressing.|1 year|All participants|||Min||Standard Deviation|Mean
2648076|NCT01688141|Secondary|Mortality|data collected from secondary care|3.5 years|Data not available for analysis.||||||
2648077|NCT01688141|Secondary|Referrals to Secondary Care and Hospitalisations|Data coillected from secondary care|3.5 years|Data not available for analysis.||||||
2648078|NCT01688141|Secondary|Other Biochemical Parameters|Nature and incidence over the study period|3.5 years|Data not available for analysis.||||||
2648079|NCT01688141|Secondary|Incidence of Cardiovascular Events|Observation of incidence of cardiovascular events over the study period|3.5 years|Data not available for analysis.||||||
2648080|NCT01688141|Secondary|Proteinuria|Proteinuria coding in practices|3.5 years|Loss to follow-up and death|||participants|||Number
2648084|NCT01688102|Other Pre-specified|Gene Expression Changes in Peripheral Blood|Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets.|baseline vs. 2 months||||GSEA Normalized Enrichment Score|||Number
2648085|NCT01688102|Other Pre-specified|Correlation Between Change in LDL Cholesterol and Change in PTH||2 months||||Pearson correlation coefficient|||Number
2648086|NCT01688102|Other Pre-specified|Correlation Between Change in LDL Cholesterol and Change in Calcium|The Correlation between change in LDL cholesterol and change in serum calcium|2 months||||Pearson correlation coefficient|||Number
2648087|NCT01688102|Secondary|Change in Parathyroid Hormone (PTH)||baseline vs.6 months||||pg/mL||Standard Deviation|Mean
2648088|NCT01688102|Secondary|Change in Serum Calcium||baseline vs. 6 months||||mg/dL||Standard Deviation|Mean
2648089|NCT01688102|Secondary|Change in 25(OH)D||baseline vs. 6 months|Data only for those who completed 6 months of therapy|||ng/ml||Standard Deviation|Mean
2648090|NCT01688102|Secondary|Change in C Reactive Protein||baseline and 6 months|Data analyzed are only for those who completed 6 months of therapy|||mg/L||Standard Deviation|Mean
2648091|NCT01688102|Secondary|Change in Triglycerides||baseline 6 months or last observation carried forward (minimum 2 months)||||mg/dL||Standard Deviation|Mean
2648092|NCT01688102|Secondary|Change in HDL Cholesterol||baseline and 6 months or last observation carried forward (minimum 2 months)||||mg/dL||Standard Deviation|Mean
2648093|NCT01688102|Secondary|Change in Total Cholesterol|Change in Total Cholesterol|baseline and 6 months or last observation carried forward (minimum 2 months)||||mg/dL||Standard Deviation|Mean
2648094|NCT01688102|Primary|Change in LDL Cholesterol Level||baseline and 6 months or last observation carried forward (minimum 2 months)||||mg/dl||Standard Deviation|Mean
2648095|NCT01688050|Primary|Device Success|Technical success (successful access, deployment, and patency of the Zenith® TX2® Low Profile Endovascular Graft), and freedom from the following: device collapse, type I or type III endoleaks requiring reintervention, and conversion to open surgical repair.|30 days|One patient had device compression (counted as a failure conservatively although the compression was not consistent with collapse of the proximal end of the device) and one patient had a site-reported Type I endoleak requiring secondary intervention.|||participants|||Number
2648096|NCT01688050|Primary|Aortic Injury-related Mortality|Any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the transected aorta.|30 days||||participants|||Number
2648097|NCT01688050|Primary|All-cause Mortality||30 days|One death was adjudicated as unrelated by the Clinical Events Committee (CEC).|||participants|||Number
2648098|NCT01688037|Secondary|Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 2|Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).|Week 2|ITT analysis set (all subjects in the safety analysis set with an evaluable AIMS dyskinesia total score value at Week 2).|||units on a scale||Standard Error|Least Squares Mean
2648099|NCT01688037|Secondary|Clinical Global Impression - Global Improvement of TD (CGI-TD)|Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse). The ANOVA analysis of CGI-TD was conducted for the pooled NBI-98854 50+100 mg group and placebo group.|Week 6|ITT analysis set (all subjects in the safety analysis set with an evaluable AIMS dyskinesia total score value at either Week 2 or Week 6).|||units on a scale||Standard Error|Least Squares Mean
2648100|NCT01688037|Primary|Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6|The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity. The primary efficacy endpoint was the change from baseline in the AIMS dyskinesia total score at Week 6 between the pooled NBI-98854 50+100 mg group and placebo group analyzed using the ANCOVA model (LOCF, ITT analysis set).|Baseline and Week 6|Intent to Treat (ITT) analysis set (all subjects in the safety analysis set with an evaluable AIMS dyskinesia total score value at either Week 2 or Week 6). Last observation carried forward (LOCF) imputation method.|||units on a scale||Standard Error|Least Squares Mean
2648101|NCT01687998|Secondary|Number of Participants With Triple Composite Endpoint of CV Death, MI, or Stroke|For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.|Baseline through End of Study (Up to 4 years)|All randomized participants.|||Participants|||Count of Participants
2648102|NCT01687998|Secondary|Number of Participants With Composite Endpoint of CV Death, MI, Stroke, or Hospitalization for UA|For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.|Baseline through End of Study (Up to 4 years)|All randomized participants.|||Participants|||Count of Participants
2648103|NCT01687998|Secondary|Number of Participants With Composite Endpoint of CV Death, MI, or Coronary Revascularization|For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.|Baseline through End of Study (Up to 4 years)|All randomized participants.|||Participants|||Count of Participants
2648104|NCT01687998|Secondary|Number of Participants With Composite Endpoint of All-Cause Mortality, MI, Stroke, Coronary Revascularization, or Hospitalization for UA|For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.|Baseline through End of Study (Up to 4 years)|All randomized participants.|||Participants|||Count of Participants
2648105|NCT01687998|Secondary|Mean Percent Change From Baseline to 3 Months in Low-Density (LDL-C) and High-Density Lipoprotein Cholesterol (HDL-C) Levels||Baseline, 3 Months|All randomized participants with evaluable LDL-C and HDL-C levels.|||percent||Standard Deviation|Mean
2648106|NCT01687998|Primary|Number of Participants With Composite Primary Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Coronary Revascularization, or Hospitalization for Unstable Angina (UA)|For component endpoints, the number of participants includes those experiencing fatal events and account for all occurrences regardless of whether or not another component event occurred previously.|Baseline to Study Completion (Up to 4 years)|All randomized participants.|||Participants|||Count of Participants
2648107|NCT01687972|Primary|Closure Time|Number of minutes taken to close post cesarean section|up to 20 minutes post intervention|Data was not collected for all participants enrolled|||minutes||Full Range|Mean
2648108|NCT01687972|Primary|Patient Scar Assessment Scale (PSAS)|assessed using the Objective scar scale score, score range 6-60 with 6 being the best score, representing normal skin and 60 being the worst score representing scar very different from the normal skin.|6 weeks|Data was unable to be collected from all participants randomized due to lack of follow-up post intervention.|||units on a scale||Full Range|Mean
2648109|NCT01687972|Primary|Patient Pain Scale|Visual Analog Score 0-10, with 0 being painless and 10 being the most severe|3 months|Data was not collected for all participants enrolled due to failure to follow-up post intervention.|||units on a scale||Full Range|Mean
2648110|NCT01687790|Secondary|Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results.|Reported are the number of indeterminate lesions with marked, moderate, or mild uptake and positive pathology results (true positives).|1 year|Analysis population included the number of indeterminate lesions that had positive pathology results.|||lesions|||Number
2648111|NCT01687790|Primary|Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results.|The number of indeterminate lesions with negative MBI uptake and negative/benign pathology results.Reported are number of indeterminate lesions with negative MBI uptake and negative/benign pathology results (true negatives).|1 year|Analysis population included the number of indeterminate lesions that had negative/benign pathology results.|||lesions|||Number
2648112|NCT01687712|Secondary|Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 3|Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 3.|Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. Percentages are based on the number of subjects in the safety population with data at the respective visit.|||Participants|||Count of Participants
2648113|NCT01687712|Secondary|Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 2|Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 2.|Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. Percentages are based on the number of subjects in the safety population with data at the respective visit.|||Participants|||Count of Participants
2648114|NCT01687712|Secondary|Number of Subjects With Detectable Specific Serum Binding to FSH by Surface Plasmon Resonance - Cycle 1|Measurement of the number of subjects with detectable specific serum binding to FSH by surface Plasmon resonance during Cycle 1.|Immunogenicity samples were taken at baseline, Visit 5 (8 days after start of treatment), Visit 9 (5 days after the end of FSH treatment), Visit 10 (18 +/- 1 days after oocyte retrieval), and Visit 11 (42 +/- 1 days after embryo transfer).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. Percentages are based on the number of subjects in the safety population with data at the respective visit.|||Participants|||Count of Participants
2648115|NCT01687712|Secondary|Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 3|Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.|Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||Participants|||Count of Participants
2648116|NCT01687712|Secondary|Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 2|Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.|Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||Participants|||Count of Participants
2648117|NCT01687712|Secondary|Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 1|Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included.|Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||Participants|||Count of Participants
2648118|NCT01687712|Secondary|Overall Summary of Adverse Events (AEs) - Cycle 1|"Summary of AEs, including the number of subjects experiencing to following during Cycle 1:~At least one AE At least one treatment related AE At least one serious AE At least one AE leading to discontinuation of study drug At least one AE due to pregnancy complication"|Measured from the start of FSH treatment through to either the end FSH treatment + 30 days (up to 46 days) or to the last Telephone Follow-up / Live Birth Questionnaire on pregnancy outcome (if applicable) (up to 10 months).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||Participants|||Count of Participants
2648119|NCT01687712|Secondary|Local and Systemic Adverse Events: Dermal Response to Injection by Severity - Cycle 1|Dermal response to r-hFSH injection as assessed by the investigator and categorized according to severity of reaction|Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH through to Day 16 after start of FSH (16 days).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||Participants|||Count of Participants
2648120|NCT01687712|Secondary|Local and Systemic Adverse Events: Dermal Response to Injection - Cycle 1|Number of subjects reporting at least one dermal response to r-hFSH injection and number of subjects reporting no dermal responses.|Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH Start through to Day 16 after start of FSH (16 days).|Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||Participants|||Count of Participants
2648121|NCT01687712|Secondary|Number of Oocytes Retrieved - Cycle 1|The number of oocytes retrieved per subject, following hCG administration in Cycle 1.|Visit 8, 34-36 hours after hCG administration|Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||Oocytes retrieved||Standard Deviation|Mean
2648122|NCT01687712|Secondary|Exposure to r-hFSH Injections: Daily Dose of r-hFSH (IU) - Cycle 1|The mean dose of r-hFSH that subjects received in a day during Cycle 1.|Measured at discretionary visits between Days 9 and 15 after FSH starts.|Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||international unit (IU)||Standard Deviation|Mean
2648123|NCT01687712|Secondary|Exposure to r-hFSH Injections: Total Dose of r-hFSH (IU) - Cycle 1|The total dose of r-hFSH that subjects received during Cycle 1.|Measured at discretionary visits between Days 9 and 15 after FSH starts.|Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||international unit (IU)||Standard Deviation|Mean
2648124|NCT01687712|Secondary|Exposure to r-hFSH Injections: Days of r-hFSH Stimulation - Cycle 1|The number of days of r-hFSH stimulation a subject received during Cycle 1.|Measured at discretionary visits between Days 9 and 15 after FSH starts|Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||days||Standard Deviation|Mean
2648125|NCT01687712|Primary|Clinical Pregnancy Rate After One Cycle of Treatment - PP Population|Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the PP population of the respective treatment arm.|Six weeks post embryo transfer|Per-protocol population, defined as a subset of the ITT population composed of all patients without any major protocol deviation (i.e. one which would affect the primary efficacy endpoint assessment).|||Participants|||Count of Participants
2648126|NCT01687712|Primary|Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population|Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the ITT population of the respective treatment arm.|Six weeks post embryo transfer|Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization.|||Participants|||Count of Participants
2648127|NCT01687478|Secondary|Mean Change From Baseline to 8 Week Endpoint in the Abnormal Involuntary Movement Scale (AIMS)|AIMS is a 12-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant's incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 and 12 are yes/no questions regarding the dental status of the participant. The total score is the sum of the scores for the 12 items and the possible total score ranges from 0 to 42. A higher total score is indicative of more severe dyskinetic movements.|Baseline, 8 Weeks|All randomized participants who received at least one dose of study drug.|||units on a scale||Standard Deviation|Mean
2648128|NCT01687478|Secondary|Mean Change From Baseline to 8 Week Endpoint in the Barnes Akathisia Scale (BAS)|BAS is used to rate observable, restless movements of drug induced akathisia and the subjective awareness of restlessness and any distress associated with the akathisia. The BAS consists of the following 3 items: an objective assessment of akathisia symptoms; a subjective assessment of the patient's awareness of inner restlessness; and a global clinical assessment of akathisia. The first two items are rated on a 4-point scale ranging from 0 (no abnormal movements or the absence of inner restlessness) to 3 (severe akathisia or the awareness of intense compulsion to move most of the time). The last item, the global clinical assessment of akathisia, is rated on a 5-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Total BAS score ranges from 0 to 14 with a higher score representing worse results.|Baseline, 8 Weeks|All randomized participants who received at least one dose of study drug.|||units on a scale||Standard Deviation|Mean
2648129|NCT01687478|Secondary|Percentage of Participants Who Achieve Remission Based on MADRS Total Score ≤10 at 8 Weeks|The MADRS consists of 10 items with each item rated on a scale ranging from 0 to 6. Fixed descriptors appear along the scale for each item at points 0, 2, 4, and 6, to standardize the gradation of response along the scale. The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.|Baseline, 8 Weeks|All randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.|||Percent of participants|||Number
2648130|NCT01687478|Secondary|Percentage of Participants Who Achieve a Response Based on a ≥50% Reduction From Baseline in MADRS Total Score|The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms.|Baseline,8 Weeks|All randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.|||Percent of participants|||Number
2648131|NCT01687478|Secondary|Mean Change From Baseline to 8 Week Endpoint in the Sheehan Disability Scale (SDS)|SDS consists of 3 items (work/school, social life/leisure activities, and family life/home responsibilities). Total scores range from 0 to 30 with higher values indicating greater disruption. Individual Item scores range from 0 to 10 with higher values indicating greater disruption.|Baseline, 8 Weeks|All randomized participants.|||Units on a scale||Standard Error|Mean
2673492|NCT01461655|Secondary|Percentage Change in Total Lesions Count|Percentage change in total leasions count from baseline to day 8|Baseline to Day 8||||percentage of change||Standard Deviation|Mean
2648132|NCT01687478|Secondary|Mean Change From Baseline to 8 Week Endpoint in the Short-Form 36 Health Survey (SF-36)|SF-36, version 2 is a generic participant-rated questionnaire and consists of 36 questions covering the following 8 health domains (subscales): general health, role limitations because of physical problems, role limitations due to emotional problems, physical functioning, bodily pain, mental health, social functioning, and vitality. Each subscale is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores, the physical component summary (PCS) and the mental component summary (MCS) were constructed based on the eight SF-36 subscales. Both PCS and MCS range from 0-100 with higher scores indicating better health or functioning.|Baseline, 8 Weeks|All randomized participants.|||units on a scale||Standard Deviation|Mean
2648133|NCT01687478|Secondary|Mean Change From Baseline to 8 Week Endpoint in the Simpson-Angus Scale (SAS)|SAS scale consists of 10 items including 7 items that address bradykinesia-rigidity and additional single items for tremor, glabellar tap,and salivation. Each item represents a specific physical condition and is rated on a 5-point category rating scale ranging from 0 (complete absence of the condition) to 4 (the condition is present to an extreme degree).The total score is obtained by adding the scores for the 10 individual items making the maximum possible score is 40. Higher scores are indicative of more severe Parkinsonian-type symptoms.|Baseline, 8 Weeks|All randomized participants who received at least one dose of study drug.|||units on a scale||Standard Deviation|Mean
2648134|NCT01687478|Secondary|Mean Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-Severity of Depression (CGI-S) Scale|CGI-S scale measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The LS mean (LSM) change from baseline, standard error was derived using MMRM methodology with factors for treatment , Pooled Investigator , Visit , (Baseline + Treatment)*Visit.|Baseline, 8 Weeks|Participants in the FAS population: all randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.|||Units on a scale||Standard Error|Least Squares Mean
2648135|NCT01687478|Primary|Mean Change From Baseline to 8 Week Endpoint in Montgomery-Äsberg Depression Rating Scale (MADRS)|The MADRS total score is the sum of the 10 items; therefore the possible MADRS total score ranges from 0 to 60. A higher MADRS total score indicates a greater severity of depressive symptoms. Least square means (LSM) change from baseline, standard error was derived using mixed model repeated measures (MMRM) methodology with factors for treatment, Pooled Investigator, Visit, (Baseline + Treatment)*Visit.|Baseline, 8 Weeks|Participants in the full analysis set (FAS) population: all randomized participants who had a baseline and at least one post-baseline MADRS total score measurement.|||Units on a scale||Standard Error|Least Squares Mean
2648136|NCT01687400|Secondary|Change in Bone Marrow Methylcytosine|-Change of total bone marrow deoxyribonucleic acid (DNA) methylcytosine from baseline to Day 10|Baseline and Day 10||||proportion of methylcytosine||Standard Deviation|Mean
2648137|NCT01687400|Secondary|Peripheral Blood Decitabine Plasma Levels|"To determine whether steady state serum concentrations of decitabine correlated with responses~Complete remission (CR), Complete remission with incomplete hematologic recovery (CRi), Partial remission (PR), Stable disease (SD), Progressive disease (PD), Not applicable (NA) - assessed according to International Working Group (IWG) criteria"|Day 4|The first 45 participants enrolled with adequate samples were analyzed using GC-MS quantification of serum decitabine levels. Sufficient funds were lacking to complete the analysis of additional participants and all participants with data analyzed are reported.|||ng/ml||Standard Deviation|Mean
2648138|NCT01687400|Secondary|Rate of Mutation Clearance During Treatment|Samples collected at baseline and after 10, 28 and 56 days of therapy; the rate of mutation clearance was measured as mean VAF change per day of treatment and was estimated using linear mixed model for repeated measurement data .|Up to Day 56|-The first 39 cases with adequate samples were serially evaluated with enhanced exome sequencing. The investigators evaluated 15 additional cases using gene panel sequencing.|||proportion of variant alleles per day||Standard Deviation|Mean
2648139|NCT01687400|Secondary|Compare Outcomes of a 10-day Decitabine Per Cycle Regimen to a 5-day Regimen (Historical Controls)|The overall response rate (CR/CRi/mCR/PR) and complete response rate (CR/CRi/mCR) will be compared with historical controls. Response assessed according to IWG criteria.|4 months (4 treatment cycles)|-Participants were evaluable for this outcome measure if they completed at least one cycle of treatment and the cycle 1 day 28 bone marrow biopsy to assess response|||percentage of participants||95% Confidence Interval|Number
2648140|NCT01687400|Primary|Correlation of Patient Specific Mutations With Overall Response Rate|"-Best response after 4 treatment cycles as assessed according to International Working Group (IWG) criteria; bone marrow for gene sequencing will be collected at baseline; mutations will be correlated with overall response rate~--Complete remission (CR), Complete remission with incomplete hematologic recovery (CRi), Marrow complete remission (mCR), Partial remission (PR), Stable disease (SD), Progressive disease (PD)"|4 months (4 treatment cycles)|-Some participants were not evaluable for this outcome measure due to sample collection quality issues and if they had repeat bone marrow biopsies and could be evaluated for responses.|||Participants|||Count of Participants
2648141|NCT01687387|Secondary|Number of Participants With Adverse Events|Number of Participants with Adverse Events based on full physical examination each treatment visit and collection of AEs|from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit, up to 24 months||||Participants|||Count of Participants
2648142|NCT01687387|Primary|Leukemia-Free Survival||from date of randomization until the date of first documented relapse, assessed up to 48 months||||MONTHS||95% Confidence Interval|Median
2648143|NCT01687296|Secondary|Mean Global Evaluation for Efficacy by Participant/Parent and Investigator|At Visit 3 (Day 8), participant/parent and investigator were asked to evaluate efficacy globally as very beneficial=1, beneficial=2, no effect=3 or worse=4. The global evaluation collected at the early withdrawal visit was included in the Visit 3. If participants were discontinued at Visit 2, then the global evaluation collected at the Visit 2 is also included in the Visit 3 for summary and analysis.|Day 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2648360|NCT01685684|Secondary|Rescue Medication Usage by Dose|Evaluation of the total amount of rescue medication used (number of doses per day, number of doses per week, and total number of doses while on-study)|Randomization Baseline through Week 12||||doses||Standard Deviation|Mean
2648144|NCT01687296|Secondary|Mean Change From Baseline in Clinical Scoring Index at Day 5 and Day 8|The clinical scoring index was assessed at Baseline (Visit 1), Day 5 and Day 8. The score assigned represented the sum of the score for each of four signs: respiratory rate, wheezing, inspiration/expiration ratio, and accessory muscle use. Each of these parameters were scored on a 4-point scale of 0 to 3 where 0=none, 1=mild, 2=moderate and 3=severe. The total score ranged from 0 to 12, where 0 indicated absence of symptoms and 12 indicated most severe symptoms. The Baseline value was the last non-missing value prior to randomization. Change from Baseline was calculated/defined as value at the indicated visit minus value at the Baseline. A negative value of change in score from Baseline indicated improvement in severity of symptoms. If participants discontinued before or on Day 5, then the clinical scoring index collected at the early withdrawal visit was included in the Visit 2. Otherwise, the clinical scoring index collected at the early withdrawal visit was included in the Visit 3|Baseline, Day 5 and Day 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2648145|NCT01687296|Secondary|Clinical Assessment of Lung Function of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) During the Treatment Period|Spirometric assessments of FEV1 and FVC were assessed at clinic visit 1 (Screening), 2 (Day 5) and 3 (Day 8). Lung function tests were performed at the approximately same time at each visit in the morning. Participants were instructed to withhold salbutamol therapy for at least 4 hour, and the highest of three FEV1 and FVC measurements were recorded. If participants discontinued before or on Day 5, then the FEV1 and FVC collected at the early withdrawal visit is included in the Visit 2. Otherwise, the FEV1, FVC collected at the early withdrawal visit was included in the Visit 3. Analysis was performed using ANCOVA with covariates of gender, centre, age and treatment.|During the treatment period at Day 5, Day 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Litres||Standard Error|Least Squares Mean
2648146|NCT01687296|Secondary|Median Number of Use of Rescue Medications During Day and Night Over the Treatment Assessment Period|The use of nebulized salbutamol (doses/puffs and frequency) were recorded on diary card in the morning and evening. The median numbers of times of use of rescue medication during day and night was calculated for each participant over the treatment assessment period. In each case, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. The outcome measure was considered missing if less than 2 days (that is., 24-hour periods) were recorded in the given treatment assessment period. The analysis only includes participants who have at least 2 days of non-missing numbers of times rescue medication (including zero) in the given treatment assessment period.|Days 2 to 8|ITT Population. Data is presented for the participants available at the time of assessment.|||Number of use of rescue medication||Full Range|Median
2648147|NCT01687296|Secondary|Median Day-time and Night-time Symptom Scores Over the Treatment Assessment Period|The symptoms of cough, sputum production, wheeze and dyspnoea were assessed in morning and evening, and recorded on participant diary cards. Day-time symptoms were scored while retiring to bed on a scale of 0 (no symptoms) to 5 (severe). Night-time symptoms were scored while waking in the morning on a scale of 0 (no symptoms) to 4 (severe). For day-time score, only data that was from Days 2 to 8 after randomization and before or on the end date of study drug was used. For night-time score, only data that are from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. The analysis only includes participants with at least 2 days of non-missing symptom scores in the given treatment assessment period.|Days 2 to 8|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Full Range|Median
2648148|NCT01687296|Secondary|Mean Evening PEF on Diary Card Over the Treatment Assessment Period|PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the evening (6:00-9:00 post meridiem [PM]) before taking any study drug. Only data that was drawn from Days 1/2 to 8 after randomization and before or on the end date of study drug was used for analysis. If participants started to take the study drug in the morning (early or on 12:00 PM), only then the evening PEF on the date of randomization was used. The outcome measure was considered missing if less than 2 days was recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using an ANCOVA model with effects due to gender, age, centre and treatment group.|Days 1/2 to 8|ITT Population. Data is presented for the participants available at the time of assessment.|||L/min||Standard Error|Least Squares Mean
2648149|NCT01687296|Primary|Mean Morning PEF on Diary Card Over the Treatment Assessment Period in Per Protocol (PP) Population|PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before talking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 5 participants from prednisone group had the missing outcome measure. Analysis was performed using ANCOVA model with effects due to gender, age ,centre and treatment group.|Days 2 to 8|PP Population comprised of all participants in the ITT Population who did not have any full protocol violations which could impact treatment effect. Data is presented for the participants available at the time of assessment.|||L/min||Standard Error|Least Squares Mean
2648159|NCT01687283|Secondary|Mean Change of Evening PEF From Baseline Over 12 Weeks|The peak expiratory flow (PEF) is a person's maximum speed of expiration, A peak flow meter was issued to participants at Visit 1 to measure the evening PEF prior to study drug and rescue medication. The best of three attempts was recorded by the participants in the diary cards. Baseline value was the assessment at Visit 2. The raw and change from baseline in daily PM PEF averaged over the 12-weeks treatment period.|Baseline (Visit 2) and up to Week 12|Intent-to-treat population. Only those participants available at the indicated time points were analyzed.|||Litres/Minute||Standard Error|Least Squares Mean
2648503|NCT01684839|Other Pre-specified|Tinel's Sign|Tinel's sign was graded as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma|20-26 months postoperatively|||||||
2648150|NCT01687296|Primary|Mean Morning Peak Expiratory Flow (AM PEF) on Diary Card Over the Treatment Assessment Period in Intent-to-Treat (ITT) Population|PEF is the maximum flow generated during a forceful exhalation, starting from full lung inflation. Participants (if needed with the help of parents or guardian) recorded on diary card the best of three PEF measurements, using a mini-Wright peak flow meter in the morning before taking any study drug. Only data that was drawn from Days 2 to 8 after randomization and on or before one day after the end date of study drug was used for analysis. The outcome measure was considered missing if less than 2 days were recorded in the given treatment assessment period. Two participants from fluticasone propionate group and 4 participants from prednisone group had the missing outcome measure. Analysis was performed using an analysis of covariance (ANCOVA) model with effects due to gender, age, centre and treatment group.|Days 2 to 8|ITT Population comprised of all participants randomized to treatment and who received at least one dose of study drug. Data is presented for the participants available at the time of assessment.|||Litres per minute (L/min)||Standard Error|Least Squares Mean
2648151|NCT01687283|Secondary|Steady-state Plasma Pharmacokinetics of Fluticasone Propionate Inhalation Solution-area Under the Plasma Concentration-time Curve for the Dose Interval [AUC (0-τ)]|AUC (0-τ) was defined as the area under the plasma concentration-time curve for the dose interval. Blood PK samples were taken on Visit 3 (Day 14±2) pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose from participants. Blood sample for PK analysis, obtained within 72 hours of last dose.|Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose at Week 2|Pharmacokinetic population. Only those participants available at the indicated time points were analyzed.|||Picogram hours per milliliter (pg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2648152|NCT01687283|Secondary|Steady-state Plasma Pharmacokinetics of Fluticasone Propionate Inhalation Solution-maximum Observed Plasma Concentration (Cmax)|Cmax was defined as maximum observed plasma concentration. Blood PK samples were taken on Visit 3 (Day 14±2) pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose from participants. Blood sample for PK analysis, obtained within 72 hours of last dose.|Pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose at Week 2|Pharmacokinetic population. Only those participants available at the indicated time points were analyzed.|||picogram per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2648153|NCT01687283|Secondary|Steady-state Plasma Pharmacokinetics of Fluticasone Propionate Inhalation Solution- Time to Maximum Observed Plasma Concentration (Tmax)|Tmax is defined as the time to maximum observed plasma concentration. Blood Pharmacokinetic (PK) samples were taken on Visit 3 (Day 14±2) pre-dose, 0.5h, 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose from participants. Blood sample for PK analysis, obtained within 72 hours of the last dose.|Pre-dose, 0.5 hour (h), 1h, 2h, 3h, 4h, 6h, 8h and 12h post dose at Week 2|Pharmacokinetics population included all participants whose PK samples were obtained and analyzed. Only those participants available at the indicated time points were analyzed.|||Hour||Geometric Coefficient of Variation|Geometric Mean
2648154|NCT01687283|Secondary|Change of Clinical Lung Function Measurement Forced Expiratory Volume in One Second (FEV1) From Baseline Over 12 Weeks|FEV1 as a measure of lung function assessment was measured at Week 2, 4, 8 and 12. FEV1 measures were performed electronically by spirometry. The highest of three technically acceptable measurements was recorded. FEV1 was measured prior to study drug administration and any rescue salbutamol use. Baseline value was the assessment at Visit 2.Change from baseline was calculated as the value at the specific time point minus baseline value.|Baseline and at Week 2, 4, 8 and 12|Intent-to-treat population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Litres||Standard Error|Least Squares Mean
2648155|NCT01687283|Secondary|Median Number of Times Rescue Medication Use Over 12 Weeks|Participants recorded the number of inhalations of rescue salbutamol inhalation aerosol used during the day and night. The baseline value was Visit 2 assessment and was derived from the last 7 days of the daily diary prior to the randomization. The analysis only included participants who had at least 2 days of non-missing numbers of times rescue medication (including zero) after randomization.|Up to week 12|Intent-to-treat population. Only those participants available at the indicated time points were analyzed.|||Number of Inhalations||Full Range|Median
2648156|NCT01687283|Secondary|Mean Change in Percentage of Rescue-free 24-hour Periods From Baseline Over 12 Weeks|"While calculating rescue-free 24-hour periods, the 24-hour period was only set to be rescue free if responses to both the morning and evening, assessments indicated no use of rescue medication. If there were symptoms in either the morning or the evening then that 24-hour period was set to as not symptom free. Similarly, if there was rescue medication use in either the morning or the evening, then that 24-hour period was set to as not rescue free. The Baseline value was Visit 2 assessment and was derived from the last 7 days of the daily diary prior to the randomization. The value provided in outcome measure data is a consolidated value over Weeks 1 to 12."|Baseline and over 12 weeks|Intent-to-treat population. Only those participants available at the indicated time points were analyzed.|||Percentage of rescue -free 24-hours||Standard Error|Least Squares Mean
2648157|NCT01687283|Secondary|Median Day-time and Night-time Symptom Scores Per Participant Over 12 Weeks|Participants recorded day-time symptom score every day in the morning and evening at bedtime before taking any rescue or study medication and before PEF measurement, using 6 point scale on Diary Card indicating 0 = No symptoms during the day and 5 =Symptoms so severe that participant could not go to work or perform normal daily activities. Night time symptoms were scored while waking in the morning on a scale of 0 (no symptoms) to 4 (severe). The value provided in outcome measure data is a consolidated value over Weeks 1 to 12.|Over 12 Weeks|Intent-to-treat population. Only those participants available at the indicated time points were analyzed.|||Score on Scale||Full Range|Median
2648158|NCT01687283|Secondary|Mean Change in Percentage of Symptom-free 24-hour Periods From Baseline Over 12 Weeks|"While calculating symptom-free 24-hour periods, a given 24-hour period was set to be symptom free only if the participant's responses to both the morning and evening assessments indicated no symptoms. The Baseline value was Visit 2 assessment and was derived from the last 7 days of the daily diary prior to the randomization. Change from Baseline was calculated as the difference between the value of the endpoint at the time point of interest and the baseline value. The value provided in outcome measure data is a consolidated value over Weeks 1 to 12."|Baseline (Visit 2) and over 12 Weeks|Intent-to-treat population. Only those participants available at the indicated time points were analyzed.|||Percentage of symptom-free 24-hour||Standard Error|Least Squares Mean
2648160|NCT01687283|Primary|Change From Baseline (Day 1 of Trt Period/Visit 2) in AM PEF Over 12 Weeks in Per Protocol Population|The peak expiratory flow (PEF) is a person's maximum speed of expiration, A peak flow meter was issued to participants at Visit 1 to measure the morning PEF prior to study drug and rescue medication. The best of three attempts was recorded by the participants in the diary cards. Baseline value was the assessment at Visit 2. The raw and change from baseline in daily AM PEF averaged over the 12-week treatment period The mean value was considered missing if less than 4 days were recorded in the baseline week prior to randomization or if less than 4 days are recorded after randomization. Analysis was performed using analysis of covariance (ANCOVA) model.|Baseline (Visit 2) and up to Week 12|Per protocol population. This population comprised of all participants in the intent-to-treat Population who did not have any protocol violations which could impact treatment effect.Only those participants available at the specified time points were analyzed.|||Litres/Minute||Standard Error|Least Squares Mean
2648161|NCT01687283|Primary|Change From Baseline (Day 1 of Treatment Period/Visit 2) in Morning Peak Expiratory Flow (AM PEF) Over 12 Weeks in Intent-to-treat Population|The peak expiratory flow (PEF) is a person's maximum speed of expiration, A peak flow meter was issued to participants at Visit 1 to measure the morning PEF prior to study drug and rescue medication. The best of three attempts was recorded by the participants in the diary cards. Baseline value was the assessment at Visit 2. The raw and change from baseline in daily AM PEF averaged over the 12-week treatment period The mean value was considered missing if less than 4 days were recorded in the baseline week prior to randomization or if less than 4 days are recorded after randomization. Analysis was performed using analysis of covariance (ANCOVA) model. Abbreviations used in statistical analysis section: standard deviation (SD) and significance (sig)|Baseline (Visit 2) and up to Week 12|Intent-to-treat population. Only those participants available at the specified time points were analyzed.|||Litres/Minute||Standard Error|Least Squares Mean
2648162|NCT01687270|Secondary|Percentage of Participants With Virologic Failure|"Virologic failure was defined as on-treatment virologic failure or virologic relapse.~On-treatment virologic failure: HCV RNA < LLOQ during treatment with subsequent detectable HCV RNA while continuing treatment~Virologic relapse: HCV RNA < LLOQ at last observed on-treatment HCV RNA measurement and HCV RNA ≥ LLOQ after stopping treatment (2 consecutive HCV RNA measurements or last available HCV RNA measurement)"|Up to Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2648163|NCT01687270|Secondary|HCV RNA and Change From Baseline at Weeks 2, 4, and 8||Baseline; Weeks 2, 4, and 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2648164|NCT01687270|Secondary|Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24||Weeks 12 and 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2648165|NCT01687270|Secondary|Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)|SVR4, SVR 24, and SVR 48 were defined as HCV RNA < LLOQ 4, 24, and 48 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4, 24, and 48|Full Analysis Set|||percentage of participants|||Number
2648166|NCT01687270|Primary|Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event||Baseline to Week 24|Safety Analysis Set|||percentage of participants|||Number
2648167|NCT01687270|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 25 IU/mL) 12 weeks following the last dose of study drug.|Posttreatment Week 12|Full Analysis Set: participants were enrolled and received at least one dose of study medication.|||percentage of participants|||Number
2648168|NCT01687257|Secondary|Change From Baseline in Model for End Stage Liver Disease (MELD) Scores|"MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity. Data are presented as improvement, no change, or worsening in MELD scores at Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV groups).~Improvement in MELD score was defined as having a baseline MELD score of 11-15 or 16-20 that changed to 0-10, or a baseline MELD score of 16-20 that changed to 11-15; no change in MELD score was defined as having no change in score group (0-10, 11-15, or 16-20) from baseline; and worsening in MELD score was defined as having a baseline MELD score of 0-10 that changed to 11-15 or 16-20, or a baseline MELD score of 11-15 that changed to 16-20.~Baseline values were the last available values on or prior to first dose date of any study drug."|Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)|Participants who were randomized to the study with available data were analyzed.|||percentage of participants|||Number
2648169|NCT01687257|Secondary|Change From Baseline in Child-Pugh-Turcotte (CPT) Score|"CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. Data are presented as improvement, no change, or worsening in CPT scores at Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV groups).~Improvement in CPT score was defined as having a decrease in CPT score from baseline, no change in CPT score was defined as having no change in CPT score from baseline, and worsening in CPT score was defined as having an increase in CPT score from baseline.~Baseline values were the last available values on or prior to first dose date of any study drug."|Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV)|Participants who were randomized to the study with available data were analyzed.|||percentage of participants|||Number
2648170|NCT01687257|Secondary|Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at End of Treatment|HVPG closely reflects the degree of portal hypertension in patients with cirrhosis. The end of treatment for the Observation group was defined as the end of the observation period. The treatment period for Group 2 was defined as the end of the observation period to the end of the treatment. Baseline values were the last available values on or prior to first dose date of any study drug.|Baseline; Week 24 (Observation) and Week 48 (SOF+RBV)|Participants who were randomized to the study with available data at baseline and end of observation or end of treatment were analyzed.|||mmHg||Standard Deviation|Mean
2648258|NCT01686750|Secondary|Proportion of HIV-infected Participants Visiting an HIV Treatment Provider in Prior 6 Months||2 years|HIV-positive survey participants|||percentage of participants|clusters|Full Range|Mean
2648171|NCT01687257|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.|Up to Posttreatment Week 24|Participants who were randomized and received at least 1 dose of study drug with available data were analyzed.|||percentage of participants|||Number
2648172|NCT01687257|Secondary|Percentage of Participants Experiencing On-Treatment Virologic Failure|"On-treatment virologic failure was defined as:~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 48 weeks|Participants who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2648173|NCT01687257|Secondary|Percentage of Participants With SVR at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)|SVR4, SVR24, and SVR48 were defined as HCV RNA < LLOQ at 4, 24, and 48 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4, 24, and 48|Participants who were randomized and received at least 1 dose of study drug with available data were analyzed.|||percentage of participants|||Number
2648174|NCT01687257|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. For the Observation/SOF+RBV group, SVR12 during the observational period was defined as HCV RNA < LLOQ for 12 consecutive weeks, any time during the observational period.|Posttreatment Week 12 (SOF+RBV) and up to 24 weeks (Observation)|Participants who were randomized to the study.|||percentage of participants|||Number
2648175|NCT01687244|Secondary|Number of Patients With Elevated Levels of Anti-Adenovirus Type 5 Antibodies in Serum.|The levels of serum anti-adenovirus type 5 antibodies as measured by ELISA were determined in all patients on the initial day of dosing (Pre-Dose Day 1), at Day 12, and for patients that were free of High-Grade disease recurrence and received subsequent subsequent doses at Day 180 (pre-dose), Day 270 (pre-dose), and Day 360 or Withdrawal.|360 Days|Data are reported at Number of Patients with a Positive Titer.|||Participants|||Count of Participants
2648176|NCT01687244|Secondary|Number of Patients With Elevated Levels of Anti-IFN alpha2b Antibodies in Serum|The levels of serum anti-IFN alpha2b antibodies as measured by ELISA were determined in all patients on the initial day of dosing (Pre-Dose Day 1), at Day 12, and for patients that were free of High-Grade disease recurrence and received subsequent doses at Day 180 (pre-dose), Day 270 (pre-dose), and Day 360 or Withdrawal.|360 Days|Data are reported at Number of Patients with a Positive Titre.|||Participants|||Count of Participants
2648177|NCT01687244|Secondary|Number of Patients With Elevated IFN alpha2b Protein Levels in Urine|The levels of urine IFN alpha2b protein as measured by ELISA were measured in all patients on the initial day of dosing Day 1 (pre-dose) and at Day 2, Day 4, Day 12, and for patients that did not have recurrence of HGD and received a second dose at Day 91 (pre-dose), Day 92, Day 94, and Day 103.|103 Days|Data are reported as the number of patients with elevated levels of IFN alpha2b levels in urine.|||Participants|||Count of Participants
2648178|NCT01687244|Secondary|Number of Patients With Elevated IFN alpha2b Protein Levels in Serum|The levels of serum IFN alpha2b protein as measured by ELISA were determined in all patients on the initial day of dosing (Pre-Dose Day 1), at Day 2, Day 4, Day 12, and for patients that were free of High-Grade disease recurrence and received subsequent doses at Day 91 (pre-dose), Day 92, Day 94, Day 103, Day 180 (pre-dose), Day 270 (pre-dose), and Day 360 or Withdrawal.|360 Days|Data are reported as the number of patients with increased levels of IFN alpha2b protein in serum.|||Participants|||Count of Participants
2648179|NCT01687244|Secondary|Number of Patients With Elevated Levels of Viral Vector in Urine|The level of viral vector as measured by qPCR in urine was determined in all patients on the initial day of dosing Day 1 (pre-dose) and at Day 2, Day 4, Day 12, and for patients that were free of High-Grade disease recurrence and received a second dose at Day 91 (pre-dose), Day 92, Day 94, and Day 103.|103 Days|Data are reported as number of patients demonstrating increased levels of viral vector by qPCR in urine.|||Participants|||Count of Participants
2648180|NCT01687244|Secondary|Number of Patients With Elevated Levels of Viral Vector in Blood|The level of viral vector as measured by qPCR in blood was determined in all patients on the initial day of dosing Day 1 (pre-dose) and at Day 2, Day 4, Day 12, and for patients that were free of High-Grade disease recurrence and received a second dose at Day 91 (pre-dose), Day 92, Day 94, and Day 103.|103 Days|Data are reported as number of patients demonstrating viral vector by qPCR in blood.|||Participants|||Count of Participants
2648181|NCT01687244|Secondary|Overall Survival in All Patients.|Overall survival was defined as the number who survived from the first dose of rAd-IFN/Syn3 to the end of the primary assessment (360 Days) or Withdrawal.|360 Days|The data are presented as the number of patients who survived the study (360 Days). All patients were monitored for this endpoint.|||Participants|||Count of Participants
2648182|NCT01687244|Secondary|Incidence of Cystectomy in All Patients|This secondary objective measures the incidence of cystectomy at 360 Days for the Efficacy Analysis Set.|360 Days|The data are presented as the number of patients per dose group having a cystectomy during the 360 days of the study.|||Participants|||Count of Participants
2648183|NCT01687244|Secondary|Incidence of High Grade-Recurrence-Free Survival at 9 Months (270 Days).|All patients were evaluated 9 Months (270 Days) after the start of treatment for recurrence of high grade disease by cytology, cystoscopy, and biopsy if clinically indicated. Patients that we free of High-Grade disease recurrence received a final dose. Data are presented as the number and percent of patients with High-Grade disease recurrence.|270 Days|All patients that received a dose at Day 180 were assessed for High-Grade disease by cytology, cystoscopy, and biopsy if clinically indicated.|||Participants|||Count of Participants
2648184|NCT01687244|Secondary|Incidence of High Grade-Recurrence-Free Survival at 6 Months (180 Days).|All patients were evaluated 6 Months (180 Days) after the start of treatment for recurrence of high grade disease by cytology, cystoscopy, and biopsy if clinically indicated. Patients that we free of High-Grade disease recurrence received another dose. Data are presented as the number and percent of patients with High-Grade disease recurrence.|180 Days|All patients receiving a dose at 90 Days were assessed at 180 Days for High-Grade disease by cytology, cystoscopy, and biopsy if clinically indicated.|||Participants|||Count of Participants
2648185|NCT01687244|Secondary|Incidence of High Grade Recurrence-Free Survival at 3 Months (90 Days).|All patients were evaluated 3 Months (90 Days) after the start of treatment for recurrence of high grade disease by cytology, cystoscopy, and biopsy if clinically indicated. Patients that we free of High-Grade disease recurrence received another dose. Data are presented as the number and percent of patients with High-Grade disease recurrence.|90 Days|All patients at 90 Days were assessed for High-Grade disease by cytology, cystoscopy, and biopsy if clinically indicated.|||Participants|||Count of Participants
2648186|NCT01687244|Secondary|Safety of rAd-IFN/Syn3|Treatment Emergent Adverse Events (AEs) for patients receiving study drug were described by NCI-CTCAE V4.03 terminology according to System Organ Class.|360 Days||||Participants|||Count of Participants
2648187|NCT01687244|Primary|Incidence of High Grade-Recurrence Free Survival at 360 Days|Following the initial treatment, patients were clinically evaluated and re-treated at the Days 90, 180, and 270 time points, as outlined below. The decision to repeat treatment was determined by the clinical response observed following the previous treatment(s). Patients were assessed for High-Grade disease recurrence by cytology, cystoscopy and, if clinically indicated, biopsies were performed to obtain accurate staging. If no evidence of recurrence of High-Grade disease was detected, then a further dose of rAd-IFN/Syn3 was administered as maintenance therapy. Patients who had recurrence of High-Grade disease were withdrawn from treatment but were followed for survival and time to cystectomy. At 360 Days, a final efficacy evaluation was performed for patients receiving 4 doses of drug. This included cystoscopy, cytology, and biopsy.|360 Days||||Participants|||Count of Participants
2648188|NCT01687218|Other Pre-specified|Problem Practices|To determine the prevalence of behavioral practices associated with anal intercourse that may affect microbicide use|27 weeks (three 8-week product use periods with 1-week washout periods between them)|||||||
2648189|NCT01687218|Other Pre-specified|Product Sharing|To determine the level of sharing of study products with non-participants and to assess with whom products are shared|27 weeks (three 8-week product use periods with 1-week washout periods between them)|||||||
2648190|NCT01687218|Other Pre-specified|Sexual Activity and Condom Use|To examine whether sexual activity or condom use varies by product used|27 weeks (three 8-week product use periods with 1-week washout periods between them)|||||||
2648191|NCT01687218|Other Pre-specified|Factors Associated With Adherence|To identify factors associated with product adherence and whether they differ by product used (FTC/TDF or TFV RG 1% gel) or regimen (daily use or RAI-associated use)|27 weeks (three 8-week product use periods with 1-week washout periods between them)|||||||
2648192|NCT01687218|Other Pre-specified|Correlation Between PK and Adherence|To assess correlation of PK with adherence measures|27 weeks (three 8-week product use periods with 1-week washout periods between them)|||||||
2648193|NCT01687218|Other Pre-specified|Mucosal Immunity|To characterize changes in mucosal immunity between baseline and the end of the daily FTC/TDF and TFV RG 1% gel product use|27 weeks (three 8-week product use periods with 1-week washout periods between them)|||||||
2648194|NCT01687218|Other Pre-specified|Pharmacodynamics|To characterize pharmacodynamic responses following oral and rectal exposure to antiretroviral drugs|27 weeks (three 8-week product use periods with 1-week washout periods between them)|||||||
2648195|NCT01687218|Secondary|Adherence: Percentage of Prescribed Doses Taken Orally or Administered Rectally in an 8-week Period|Compare percentage of prescribed doses taken orally or administered rectally in an 8-week period based on the Final Converged Rates. Final Converged Rates were measured first via self-report through Short Message Service (SMS). The clinic staff also reported the most likely number of doses taken. Finally, the MTN Behavioral Research Working Group (BRWG) provided the final estimate of the number of doses taken for each participant for each period based on self-report, staff estimates and PK testing results. Note that these final judgement data are missing if PK results are missing.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|Evaluable participants with Final Converged Rates of prescribed doses.|||Participants|||Count of Participants
2648196|NCT01687218|Secondary|Pharmacokinetics: End Period Tenofovir-Diphosphate (TFV-DP) Concentrations (log10 ng/mg) in Rectal Tissue|Compare end period tenofovir-diphosphate (TFV-DP) concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|Participant end periods with tenofovir-diphosphate (TFV-DP) concentrations (log10 ng/mg) in rectal tissue among evaluable participants.|||log10 ng/mg||Standard Deviation|Mean
2648197|NCT01687218|Secondary|Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Sponge|Compare emtricitabine concentrations in rectal sponge among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|Participant periods with emtricitabine (FTC) concentrations (log10 ng/mg) in rectal sponge specimens among evaluable participants.|||log10 ng/mg||Standard Deviation|Mean
2648198|NCT01687218|Secondary|Pharmacokinetics: End Period Emtricitabine (FTC) Concentrations (log10 ng/mg) in Rectal Tissue|Compare end period emtricitabine concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|Participant end periods with emtricitabine (FTC) concentrations (log10 ng/mg) in rectal tissue among evaluable participants.|||log10 ng/mg||Standard Deviation|Mean
2648199|NCT01687218|Secondary|Pharmacokinetics: Emtricitabine (FTC) Concentrations (log10 ng/mL) in Blood Plasma|Compare emtricitabine concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|Participant periods with emtricitabine (FTC) concentrations (log10 ng/mL) in blood plasma among evaluable participants.|||log10 ng/mL||Standard Deviation|Mean
2648200|NCT01687218|Secondary|Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Sponge|Compare tenofovir concentrations in rectal sponge specimens among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|Participant periods with tenofovir concentrations (log10 ng/mg) in rectal sponge specimens among evaluable participants.|||log10 ng/mg||Standard Deviation|Mean
2648504|NCT01684839|Secondary|Cold Intolerance Severity Score (CISS) Questionnaire|The maximum score was 100 and was grouped into 4 ranges (0-25; 26-50; 51-75; and 76-100), corresponding to mild, moderate, severe, and extreme severity, respectively.|20-26 months postoperatively|||||||
2648201|NCT01687218|Secondary|Pharmacokinetics: End Period Tenofovir (TFV) Concentrations (log10 ng/mg) in Rectal Tissue|Compare end period tenofovir concentrations in rectal tissue among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|Participant end periods with tenofovir concentrations (log10 ng/mg) in rectal tissue among evaluable participants.|||log10 ng/mg||Standard Deviation|Mean
2648202|NCT01687218|Secondary|Pharmacokinetics: Tenofovir (TFV) Concentrations (log10 ng/mL) in Blood Plasma|Compare tenofovir concentrations in blood plasma among daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel groups.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|Participant periods with tenofovir concentrations (log10 ng/mL) in blood plasma among evaluable participants.|||log10 ng/mL||Standard Deviation|Mean
2648203|NCT01687218|Primary|Acceptability: Participant Self-report of Likelihood of Product Use if Shown to be Effective. N1-If This Product Provides Some Protection How Likely Would You be to Take it?|To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of likelihood to use product in the future, a variable was created by combining Section N. Likelihood to Use Product in the Future of the MTN-017 Follow-up Behavioral Questionnaire questions 1A, 1B, and 1C. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.|||participants|||Number
2648204|NCT01687218|Primary|Acceptability: Participant Self-report of Ease of Use. I1-Overall How Easy or Difficult Was it to Use the Product?|To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of ease of use, a variable was created to compare regimens. This variable combines questions 1A and 1BC from Section I. Ease of Use of the MTN-017 Follow-up Behavioral Questionnaire. Categories 1 and 2 were combined and categories 3 and 4 were combined to create dichotomous variables.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.|||participants|||Number
2648205|NCT01687218|Primary|Acceptability: Participant Self-report of Liking the Product. H1-Overall How do You Feel About the Product You Used Recently?|To evaluate and compare acceptability of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Consistent with the acceptability endpoint of liking the product, a variable was created by combining from Section H. Liking the Product of the MTN-017 Follow-up Behavioral Questionnaire question 1A and question 1BC. Categories 1 and 2 were combined and categories 3 and 4 were combined to create a dichotomous variable.|27 weeks (three 8-week product use periods with 1-week washout periods between them)|All primary analyses are based on the data from evaluable participants. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.|||participants|||Number
2648206|NCT01687218|Primary|Safety: Grade 2 or Higher Adverse Events|Compare the safety profiles of daily FTC/TDF tablet, daily TFV RG 1% gel, and RAI-associated TFV RG 1% gel. Analysis of the primary endpoint of grade 2 or higher AEs was performed on only the evaluable participants based on the principle of intent-to-treat (ITT) whereby participants who were randomized were included in the analysis regardless of whether or not they received product in a given period (i.e, were lost to follow-up, or terminated early and/or were on a product hold).|27 weeks (three 8-week product use periods with 1-week washout periods between them)|Among the 187 evaluable participants. One participant was terminated before the Initiate Period visit of his/her Period 3 (Oral Tablet regimen period). Thus, this participant is removed from the analysis of the oral period regimen.|||participants|||Number
2648207|NCT01687179|Primary|Safety of Combination Therapy With Sirolimus and Hydroxychloroquine in LAM Patients|"The Primary endpoint of this study was safety. Safety was assessed based on the adverse events and serious adverse events that occurred in these patients when they were on this combination therapy. Percentage of adverse events in each system at a dose was calculated from the total adverse events at that dose. Subjects were closely monitored and adverse events were classified and graded according to the Common Terminology Criteria for Adverse Events, (CTCAE) Version 4.0."|48 weeks||||Percentage of adverse events|||Number
2648208|NCT01687166|Secondary|Acute Success|Demonstration that the investigational group acute procedural success rate is non-inferior to that of the control group. Acute procedural success is defined as a subject that successfully had all clinically relevant veins electrically isolated, by demonstration of entrance block at a minimum and no evidence of exit conduction with the randomized investigational or control catheter only.|Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation|Outcome Measures were not assessed for the non-randomized participants.|||Participants|||Count of Participants
2648209|NCT01687166|Primary|Chronic Success Rate|"The primary effectiveness of the Blazer OI catheter will be evaluated by demonstrating that the proportion of subjects free from failure* in the investigational group is non-inferior to those in the control group.~*failure is defined as a randomized subject being an acute procedural failure, having more than one repeat procedure during the 90 day blanking period or having a documented symptomatic atrial fibrillation, atrial tachycardia, atrial fibrillation between 91 days and 12 months post-procedure."|Within 12 months of the index procedure|Outcome Measures were not assessed for the non-randomized participants.|||Participants|||Count of Participants
2648210|NCT01687166|Primary|Procedure-related Complication Free Rate|"The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group serious adverse event rate is non-inferior to that of the control group.~The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group rate of significant pulmonary vein stenosis (≥70% reduction in diameter from baseline) and atrio-esophageal fistulas is non-inferior to that of the control group."|12 Months|Outcome Measures were not assessed for the non-randomized participants.|||Participants|||Count of Participants
2648211|NCT01687114|Primary|Proanthocyanidin A2|proanthocyanidin A2 concentration in urine is determined using a LC-MS/MS method.|24-hour urine and morning spot urine|The subjects included 5 generally healthy premenopausal women, age 20-40 y, with a body mass index (BMI) ranging from 18.5 to 25 kg/m2. The specific operational criteria used to assess eligibility included: age, BMI, premenopausal status, not pregnant or planning to become pregnant.|||ng/mg creatinine||Standard Deviation|Mean
2648212|NCT01687101|Primary|Efficacy of STOPAIN in the Acute Treatment of Migraine|"To evaluate the efficacy of STOPAIN in the acute treatment of migraine as measured by Pain Freedom (headache pain intensity level equal to no pain) at 2 hours post dose using a four point numeric rating scale (0=no pain, 1= mild pain, 2=moderate pain, 3=severe pain)."|2 hours after the time of gel application||||units on a scale||Full Range|Mean
2648213|NCT01687088|Primary|Comparison of UPSIT Scores Between Subjects and Controls at Two Time Points|"Migraineurs and controls will take the University of Pennsylvania Smell Identification Test (UPSIT) in the office. The UPSIT test is a series of 40 questions and the score is the number of questions answered correctly. Each question is multiple choice and must be answered. The number of correct answers regarding the smells being experienced is the subjects score. The higher the score the better the sense of smell. This allows groups to be compared. In this study after the first visit, migraineurs will be given the UPSIT test without a headache and then they will self-administer the UPSIT during a migraine attack day at home.~Age and sex matched controls will also take the first UPSIT in the office. They will take second UPSIT 2 weeks later at home."|Chronic migraineurs up to 12 months. Controls up to 2 weeks.||||UPSIT Score||Standard Error|Mean
2648214|NCT01687036|Secondary|AE|18 AEs were recorded in 7 out of 10 patients. 3 AEs were definitely related to treatment and one AE was definitely device related. All patients recovered completely.|First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013||||participants|||Number
2648215|NCT01687036|Secondary|Cumulative Cryoablation Time|"Cryoablation time was defined as the cumulative duration of all cryoapplications in each single study patient.~Average cryoablation time was 114 min. 33 sec. (range 80 - 130 min.)."|First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013||||minutes||Standard Deviation|Mean
2648216|NCT01687036|Secondary|Fluoroscopy Time|"Fluoroscopy time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo - application. Accumulated time using fluoroscopy during procedure time.~Average fluoroscopy time was 44 min. 01 sec. (range 17 min. 03 sec. - 59 min.)."|Treatment Duration||||minutes||Standard Deviation|Mean
2648217|NCT01687036|Secondary|Procedure Time|Procedure time was defined from introduction of the CoolLoop® catheter into the left atrium until removal of the CoolLoop® catheter from the left atrium after termination of the last cryo-application.|Average procedure time: 251 min. 06 sec. (range 126 - 320 min.)||||minutes||Standard Deviation|Mean
2648218|NCT01687036|Secondary|Clinical Efficacy of Catheter Ablation|During follow-up recurrence of AF was reported by the patient and documented by ECG in 8 patients (80%). 2 patients remained free of recurrences of AF.|First patient - first visit: September 11, 2012; Last patient - last visit: March 26, 2013||||participants|||Number
2648219|NCT01687036|Secondary|Acute Efficacy of Catheter Ablation|Absolute percentage of PVs isolated with the CoolLoop® catheter.|Treatment Duration||||percentage of isolated PVs|||Number
2648220|NCT01687036|Secondary|Feasibility of Catheter Ablation Measured by Number of Participants Treated With the AFreeze Cryoablation System.|Feasibility, defined by the ability to position the catheter in the proximal part in each of the pulmonary veins (PVs) using an over-the-wire technique, forming the cryo-applicator of the catheter to a loop by operating the catheter handle, positioning the loop at the wall of the PV antrum and delivering cryothermia.|Treatment Duration||||participants|||Number
2648221|NCT01687036|Primary|Tolerability of Ablation Using the AFreeze Cryoablation System|"The primary study objective is assessed by recording all Adverse Events (AEs).~Primary endpoint: measurement of the following parameters:~- deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment)."|Treatment duration, up to 6 hours||||AE (device related)|||Number
2648222|NCT01687036|Primary|Safety of Ablation Using the AFreeze Cryoablation System Consisting of the CoolLoop® Ablation Catheter, Its Steerable Sheath and the Cryoconsole Cryo-Caddy Assessed by Recording All Serious Adverse Events (SAEs)|"The primary study objective is assessed by recording all Serious Adverse Events (SAEs).~Primary endpoint: measurement of the following parameters:~deformation of the catheter loop resulting in entrapment of the catheter in the heart and difficulties removing the catheter during visit 3 (treatment).~phrenic nerve palsy during visit 3 (treatment).~onset and time course between visit 3 (treatment) and visit 5 (discharge) of death, pericardial tamponade, valve damage requiring surgery and hemorrhage requiring transfusion.~onset and time course between visit 3 (treatment) and visit 9 (final visit) of atrioesophageal fistula, sepsis, abscesses, endocarditis, stroke, transient ischemic attack, and PV stenosis requiring intervention."|3 months||||participants|||Number
2648223|NCT01686958|Primary|Safety - Evaluate the Severity of Treatment Related Adverse Events|"Severity of treatment/device related adverse events were evaluated in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) standard (version 4), published by the National Cancer Institute (NCI).~There was no intraoperative complication, no rectal injury or fistula and no severe urinary incontinence. No Grade 4 (G4) or higher adverse events and only one attributable Grade 3 (G3) event; reported below. The common and significant Grade 1 (G1) and Grade 2 (G2) genitourinary events have also been reported."|12 months from the Treatment Date|The safety population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device.|||% of subjects||95% Confidence Interval|Number
2648224|NCT01686958|Other Pre-specified|Treatment Efficacy - Quality of Life - Bowel Habits|"Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, Bowel Habits domain of the UCLA Prostate Cancer Index Short Form (UCLA-PCl-SF-BH), which focuses on bowel symptoms.~Minimum score value - 0 Maximum score value - 100 A higher score corresponds to better outcome"|Baseline and 12-months post Treatment|One patient did not complete the 12-month visit questionnaire in its entirety, hence overall number of patients analyzed is 29 versus 30 at baseline.|||units on a scale||Inter-Quartile Range|Median
2648225|NCT01686958|Other Pre-specified|Treatment Efficacy - Quality of Life - Erectile Function|"Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, Erectile Function EF domain of the International Index of Erectile Function (IIEF-15), which focuses on erectile symptoms.~Minimum score value - 0 Maximum score value - 30 A higher score corresponds to a better outcome; lower score indicative of erectile dysfunction"|Baseline and 12-months post Treatment|One patient did not complete the 12-month visit questionnaire in its entirety, hence overall number of patients analyzed is 29 versus 30 at baseline.|||units on a scale||Inter-Quartile Range|Median
2648226|NCT01686958|Other Pre-specified|Treatment Efficacy - Quality of Life - Urinary Symptoms|"Evaluate quality of life in the first 12 months following Treatment compared to Baseline, using a standardized questionnaire, International Prostate Symptom Score (IPSS), which focuses on urinary symptoms.~Total Score: 0 - 35 0-7 - mildly symptomatic 8-19 - moderately symptomatic 20-35 - severely symptomatic"|Baseline and 12-months post Treatment|One patient did not complete the 12-month visit questionnaire in its entirety, hence overall number of patients analyzed is 29 versus 30 at baseline.|||units on a scale||Inter-Quartile Range|Median
2648227|NCT01686958|Other Pre-specified|Treatment Efficacy - PSA|Based on measurements obtained at each study visit, characterize the pattern of PSA response within the first 12 months following treatment in comparison to baseline.|As per the Study Schedule, measured at 1-month, 3-months, 6-months and 12-months from the Treatment Date compared to Baseline||||ng/ml||Inter-Quartile Range|Median
2648228|NCT01686958|Other Pre-specified|Treatment Efficacy - Biopsy|Evaluate the effectiveness of the treatment to achieve disease control at 12 months based on biopsy results.|12 months from the Treatment Date|One patient did not complete the 12-month visit, therefore 29 patients were included in this analysis.|||Participants|||Count of Participants
2648229|NCT01686958|Secondary|Feasibility - Evaluate the Effectiveness of the Investigational System to Thermally Coagulate Prostate Tissue Conforming to the Target Volume With a High Degree of Accuracy and Precision|Conformal thermal coagulation of prostate tissue will be determined quantitatively using measures of targeting accuracy which compare the spatial difference between the target volume and target temperature isotherm determined from MR thermometry images acquired during treatment.|On Treatment Date|The analysis population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device.|||mm||Standard Deviation|Mean
2648230|NCT01686958|Primary|Safety - Evaluate the Frequency of Treatment Related Adverse Events|All reported adverse events were recorded. The frequency was measured as the number of study participants who experienced a treatment/device related adverse event after receiving treatment delivery with PAD-105, the investigational device.|12 months from the Treatment Date|The safety population consists of all subjects who underwent treatment delivery with PAD-105, the investigational medical device.|||Participants|||Count of Participants
2648231|NCT01686932|Secondary|Number of Occurrence of Pre-defined ECG Findings During 4 Days of Continuous ECG Monitoring at Baseline and in the 8th Week of Periods 1 and 2|Number of Occurrence of pre-defined ECG findings during 4 days of continuous ECG monitoring at baseline and in the 8th week of Periods 1 and 2. ECG data were continuously recorded and analyzed over a period of 4 days simultaneously with continuous glucose monitoring. It assessed number of any Vertical Electric(al) Sounding (VES), number of 2 consecutive VES [couplets], and number of >3 consecutive VES [salves]|after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||number of occurrence||Standard Deviation|Mean
2648232|NCT01686932|Secondary|Percentage Change From Baseline of Pro-insulin/C-peptide Ratios After 8 Weeks of Treatment Period 1 & Period 2|Percentage Change from baseline of pro-insulin/C-peptide ratios after 8 weeks of treatment Period 1 & Period 2 Higher pro-insulin / C-peptide ratios (expressing disproportional hyperproinsulinemia) may be associated with increasing beta cell dysfunction and more inefficient pro-insulin processing|Baseline, after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||Percentage Change||Standard Deviation|Mean
2648233|NCT01686932|Secondary|Change From Baseline of Inflammatory Biomarkers Interleukin 6 (IL-6) After 8 Weeks of Treatment in Period 1 & Period 2|The inflammatory biomarkers IL-6 was assessed at baseline and after 8 weeks of treatment Period 1 & Period 2|Baseline, after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||pg/L||Standard Deviation|Mean
2648234|NCT01686932|Secondary|Change From Baseline of Inflammatory Biomarkers High Sensitivity C-reactive Protein (hsCRP) After 8 Weeks of Treatment in Period 1 & Period 2|The inflammatory biomarkers hsCRP was assessed at baseline and after 8 weeks of treatment Period 1 & Period 2|Baseline, after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||mg/L||Standard Deviation|Mean
2648235|NCT01686932|Secondary|Number of Participants With ECG Abnormalities Depending on Hypoglycemic Events After 8 Weeks of Treatment Period 1 & Period 2|ECG abnormalities are defined as either: • Occurrence of >30 ventricular extrasystoles (VES) per hour or • Occurrence of ≥2 consecutive VES (Couplets) or • Occurrence of ≥3 consecutive VES (Triplets) or • QT-time corrected for heart rate (QTc) >440 ms. after 8 weeks of treatment Period 1 & Period 2|after 8 weeks of treatment Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||participants|||Number
2648236|NCT01686932|Secondary|Glucose Fluctuations During the Day Under Vildagliptin Treatment Compared to Sitagliptin Treatment on Day 2 After 8 Weeks of Treatment Period 1 & Period 2|Glucose fluctuations are assessed by the mean amplitude of glycemic excursions (MAGE) and standard deviations (SD) (Service et al., 1970). on day 2 after 8 weeks of treatment Period 1 & Period 2|Day 2 after 8 weeks of treatment Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||mmol/L||Standard Deviation|Mean
2648237|NCT01686932|Secondary|Number of Severe Hypoglycemic Events During Vildagliptin Treatment Compared to Sitagliptin Treatment After 8 Weeks of Treatment in Period 1 and Period 2|Severe hypoglycemic events are defined as any episode requiring the assistance of another party or measured plasma glucose levels of <40 mg /dL. Assessed by self-monitored blood glucose (SMBG)After 8 weeks of treatment in Period 1 and Period 2|after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||severe hypoglycemic events|||Number
2655722|NCT01623466|Primary|Levonorgestrel Pharmacokinetic Profile|The percentage of subjects with a minimal LNG level below pre-specified threshold of 175 pg/mL during the study.|8 weeks|Primary PK population|||% of subjects below 175 pg/mL|||Number
2648238|NCT01686932|Secondary|Mean Amplitudes of Hypoglycemic Events (mmol/L) Measured With Continuous Glucose Monitoring (CGM) Over 4 Days After 8 Weeks of Treatment for Period 1 & Period 2|To evaluate by CGM measurement the grade of severity of hypoglycemia measured as the mean amplitude over 4 days after 8 weeks of treatment in Period 1 & Period 2|after 8 weeks Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||mmol/L||Standard Deviation|Mean
2648239|NCT01686932|Secondary|Mean Duration of Hypoglycemic Events (Min.) Measured With Continuous Glucose Monitoring (CGM) Over 4 Days After 8 Weeks of Treatment for Period 1 & Period 2|the mean duration of hypoglycemic events is detected by continuous glucose monitoring (CGM)measurement.|after 8 weeks for Period 1 & Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||minutes||Standard Deviation|Mean
2648240|NCT01686932|Secondary|Number of Hypoglycemic Events During Vildagliptin Treatment Compared to Sitagliptin Treatment.|Hypoglycemic events are defined as blood glucose values <70 mg/dL measured by a self-monitored blood glucose (SMBG) or continuous glucose monitoring (CGM) measurement regardless of any symptoms suggestive of low blood glucose.|after 8 weeks period 1 and Period 2|Full Analysis Set (FAS) included all patients that was treated with study medication.|||number of hypoglycemic events|||Number
2648241|NCT01686932|Primary|Hypoglycemic Profile of Vildagliptin Compared to Sitagliptin Over 4 Days After 8 Weeks of Treatment in Period 1 & 2|The hypoglycemic profile is defined as the area under the curve glucose-time profile obtained by continuous glucose monitoring Interstitial glucose values below 3.9 mmol/L (averaged over 5 minutes) were considered relevant for the estimation of the interstitial glucose AUC in the hypoglycemic range These AUC<3.9mmol/L/5min. values were summed up over 4 days (unit: mmol/L/4d) or over 24 hours at measurement Days 2, 3, 4, and 5 (unit: mmol/L/24h). Lower values for AUC reflect less intense hypoglycemia.|baseline and 0-24 hours post-dose on Days 2 to 5|Full Analysis Set (FAS) included all patients that was treated with study medication.|||mmol/L/4d||Standard Deviation|Mean
2648242|NCT01686828|Secondary|Changes in Adipose Tissue Gene Expression|We examined whether differences in lipoprotein lipase expression would be evident across study treatment groups. RNA was isolated from whole adipose tissue gene expression, and complementary DNA (cDNA) was synthesized from 1.5 ug of RNA per sample. Gene expression was measured by polymerase chain reaction (PCR) using predesigned TaqMan® Gene Expression Assays. Standard curves were included on each plate, so Ct values were converted to copy numbers of the target gene. Expression values were normalized to the geometric mean of the housekeeping genes phosphoglycerate kinase and 18s.|4 weeks|Subjects were included who had adipose tissue samples available from both baseline and week 4 (end-of-treatment) visits.|||gene copy number per ng RNA||Standard Deviation|Mean
2648243|NCT01686828|Secondary|Changes in Body Composition|Fat mass and lean mass were measured by dual energy X-ray absorptiometry (DEXA) at baseline and at the end of the 4 week treatment period|4 weeks||||kg||Standard Deviation|Mean
2648244|NCT01686828|Primary|Insulin Sensitivity Quantified by Matsuda Index|Whole body insulin sensitivity as quantified by Matsuda Index at the end of the treatment period, calculated by the following equation: 10,000/square root of(FPG*FI)*(FPG+PG30*2+PG60*2+PG90*2+PG120)/8*(FPI+PI30*2+PI60*2+PI90*2+PI)/8). FPG=fasting plasma glucose level; FPI=fasting plasma insulin level; PG30,60,90, and 120=plasma glucose levels sampled at 30,60,90, and 120 minutes after oral glucose load; PI30,60,90, and 120=plasma insulin levels sampled at 30,60,90, and 120 minutes after the oral glucose load|4 weeks|Of the 53 subjects who attended the baseline study visit, 2 withdrew from the study and 1 was discontinued due to a protocol violation. 50 subjects completed the week 10 study visit. Of these, 5 subjects were excluded from the final analyses; 1 was found to have undiagnosed diabetes, and 4 subjects were excluded due to study drug non-adherence.|||units on a scale||Inter-Quartile Range|Median
2648245|NCT01686750|Secondary|Proportion Reporting Spouse Ever Tested for HIV||2 years|Participants with a spouse (opposite sex)|||percentage of participants|clusters|Full Range|Mean
2648246|NCT01686750|Secondary|Vicarious Stigma as Assessed by 6-item Stigma Scale|Summed score from a 6-item stigma scale (range 0-18), with higher values indicating more perceived stigma|2 years||||score on a scale|clusters|Full Range|Mean
2648247|NCT01686750|Secondary|Number of Unprotected Sexual Acts Reported by MSM||2 years|Samples were not collected therefore there is no data to report.||||||
2648248|NCT01686750|Secondary|Proportion With Depressive Symptoms|Participants with Score >=10 on Patient Health Questionnaire-9|2 years||||percentage of participants|clusters|Full Range|Mean
2648249|NCT01686750|Secondary|Proportion Reporting Substance Abuse Among MSM||2 years|Samples were not collected therefore there is no data to report.||||||
2648250|NCT01686750|Secondary|Number of Non-main Male Partners in Prior 6 Months in MSM||2 years|Participants at MSM sites|||partners|clusters|Full Range|Mean
2648251|NCT01686750|Secondary|Proportion of MSM Reporting Unprotected Anal Intercourse With Non-main Partner in Prior 6 Months||2 years|Participants at MSM sites|||percentage of participants|clusters|Full Range|Mean
2648252|NCT01686750|Secondary|Proportion of IDU Reporting Drug Abstinence in Prior 6 Months||2 years|Participants at PWID sites|||percentage of participants|clusters|Full Range|Mean
2648253|NCT01686750|Secondary|Proportion of IDU Reporting Needle or Syringe Sharing in Prior 6 Months||2 years|Participants from the PWID sites|||percentage of participants|clusters|Full Range|Mean
2648254|NCT01686750|Secondary|Prevalence of Recent HIV Infection||2 years|Samples were not collected therefore there is no data to report.||||||
2648255|NCT01686750|Secondary|Proportion of HIV-infected Participants With Suppressed HIV RNA|Proportion of HIV-positive participants meeting criteria for antiretroviral therapy [cluster of differentiation 4 (CD4) count <350 cells/mm3 or current or past use of antiretroviral therapy)] who have a suppressed viral load (HIV RNA <150 copies/mL)|2 years|HIV-positive participants who meet criteria for antiretroviral therapy|||percentage of participants|clusters|Full Range|Mean
2648256|NCT01686750|Secondary|Community Viral Load|Average log(10) HIV RNA concentration among HIV-infected participants|2 years|Samples were not collected therefore there is no data to report.||||||
2648257|NCT01686750|Secondary|Proportion of Antiretroviral Therapy-eligible HIV-infected Participants Using Antiretroviral Therapy||2 years|HIV-positive participants that meet criteria for antiretroviral therapy in India at the time of the study|||percentage of participants|clusters|Full Range|Mean
2648261|NCT01686646|Secondary|Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test|For the Divided Attention task, participants were required to respond on hearing the no. '8' in a continuous stream of numbers through headphones or seeing a letter 's' on screen. This was identified in the output file by a value of '8' in 'NUMBER' column or 's' in 'LETTER' column. If a subject responded incorrectly (pressed the response button at the wrong time), this was identified by a value of '-1' in 'CORRECT=1' column. The number of incorrect responses was calculated as the total no. of records where 'CORRECT=1' had a value of '-1'. If the subject missed a target (failed to press the response button on hearing the no. '8' or seeing the letter 's'), this was considered a missed response. The number of missed responses was calculated as the no. of records where there was a value of '8' in 'NUMBER' column or 's' in 'LETTER' column and a value of '0' in the 'CORRECT=1' column.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||incorrect and missed responses||Standard Error|Mean
2648262|NCT01686646|Secondary|Change From Baseline in Mean Time of Accurate Responses to DAT Cognitive Test|The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs).|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||msec||Standard Error|Least Squares Mean
2648263|NCT01686646|Secondary|Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Divided Attention task. Participants were required to respond whenever they heard the number '8' in a continuous stream of numbers presented through headphones or saw a letter 's' on the screen . This was identified in the output file by a value of '8' in the 'NUMBER' column or by a value of 's' in the 'LETTER' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||Correct responses||Full Range|Median
2648264|NCT01686646|Secondary|Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test|For sustained auditory attention task, participants were required to respond on hearing the no. '8' in a continuous stream of numbers through headphones. It was identified in output file by a value of '8' in 'NUMBER' column. For sustained visual attention task, participants responded to letter 's' every time it appeared in a continuous stream of letters presented on screen. This was identified in output file by a value of 's' in 'LETTER' column. If a subject responded incorrectly (pressed the response button at the wrong time), it was identified by a value of '-1' in 'CORRECT=1' column. The no. of incorrect responses was calculated as total no. of records where 'CORRECT=1' had a value of '-1'. The no. of missed responses (when subject failed to press the response button on hearing the number '8' or seeing the letter 's'), was calculated as the no. of records where there was a value of '8' in 'NUMBER' column or 's' in the 'LETTER' column and a value of '0' in the 'CORRECT=1' column.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||incorrect and missed responses||Standard Error|Mean
2648265|NCT01686646|Secondary|Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task|The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs).|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||msec||Standard Error|Least Squares Mean
2648266|NCT01686646|Secondary|Change From Baseline in Number of Accurate Responses to Sustained Attention Tasks (SAT) Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained auditory attention task, participants were required to respond whenever they heard the number '8' in a continuous stream of numbers presented through headphones. This was identified in the output file by a value of '8' in the 'NUMBER' column. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appeared in a continuous stream of letters presented on a screen. This was identified in the output file by a value of 's' in the 'LETTER' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||Correct responses||Full Range|Median
2648267|NCT01686646|Secondary|Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task|The no. of inaccurate responses to RVIP was determined from cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of screen. They responded to consecutive sequences of 3 odd or even numbers by pressing the corresponding response button. This was identified in the output file by a value of '1' in the 'TARGET=1' column. If a subject responded incorrectly to stimuli (pressed the response button at the wrong time), this was identified by a value of '-1' in the 'CORRECT=1' column. The no. of incorrect responses was calculated as the total no. of records where 'CORRECT=1' had a value of '-1'. If the subject missed a target (failed to press the response button within 600 msecs of being presented with a string of 3 consecutive even or odd numbers), this was considered a missed response and was calculated as the no. of records where there was a value of '1' in the 'TARGET=1' column and a value of '0' in the 'CORRECT=1' column.|Baseline, 60 minutes and up to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||inaccurate and missed responses||Standard Error|Mean
2648268|NCT01686646|Secondary|Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task|The mean time of accurate responses was defined as the mean reaction time for the correct responses. For records with '1' in the 'CORRECT=1' column, the mean time of accurate response was calculated as the summation of the response time values divided by number of records with '1' in the 'CORRECT=1' column. The result was multiplied by 1000 to convert into milliseconds (msecs).|Baseline, 60 minutes and upto 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||milliseconds (msec)||Full Range|Median
2648269|NCT01686646|Secondary|Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.|Baseline to 120 minutes post treatment administration|ITT population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||Correct responses||Standard Error|Least Squares Mean
2648270|NCT01686646|Primary|Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.|Baseline to 60 minutes post treatment administration|Intent to Treat (ITT) population: all randomized participants who received study treatment and had at least one post-baseline efficacy evaluation.|||Correct responses||Standard Error|Least Squares Mean
2648271|NCT01686633|Secondary|Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use and each morning. The best of three measurements was recorded. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily PM PEF over the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
2648272|NCT01686633|Secondary|Change From Baseline in Daily Morning (AM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use and each morning. The best of three measurements was recorded. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters per minute||Standard Error|Least Squares Mean
2648273|NCT01686633|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
2648274|NCT01686633|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. The Baseline value was derived from the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week treatment period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
2649531|NCT01676701|Secondary|Change From Baseline to 12-Week Endpoint in Achieving American College of Rheumatology (ACR) Core Set||Baseline, Week 12|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
2648275|NCT01686633|Secondary|Change From Baseline in Clinic Visit Trough FEV1 at the End of the 12-week Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on-treatment. Change from Baseline in trough FEV1 at the end of the 12-week treatment period was defined using the 24-hour post-dose serial FEV1 measurement taken at the Week 12 clinic visit. Change from Baseline was calculated as the Week 12 trough FEV1 value minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline and Week 12|ITT Population. Only those participants with non-missing covariates and post-Baseline FEV1 data were analyzed.|||Liters||Standard Error|Least Squares Mean
2648276|NCT01686633|Primary|Change From Baseline in Weighted Mean Forced Expiratory Volume in One Second (FEV1) Over 0 to 24 Hours Post-dose at the End of the 12-week Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean was calculated from the pre-dose FEV1 (within 30 minutes prior to dosing) and post-dose FEV1 measurements at 5, 15, and 30 minutes and at 1, 2, 3, 4, 5, 12, 16, 20, 23, and 24 hours on Day 84/Week 12. At each time point, the highest of three technically acceptable measurements was recorded. Change from Baseline was calculated as the weighted mean of the 24-hour serial FEV1 measures on Day 84/Week 12 minus the Baseline value. Baseline was the pre-dose FEV1 measurement value obtained at Visit 3. The analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of Baseline FEV1, region, sex, age, and treatment.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants randomized to treatment, who received at least one dose of the study medication. Only those participants with non-missing covariates and Week 12 weighted mean data were analyzed.|||Liters||Standard Error|Least Squares Mean
2648277|NCT01686581|Secondary|Percentage of Participants With Good or Very Good Responses on the 4-Point Treatment Satisfaction Scale|"At each visit, participants and physicians were asked to indicate the level of satisfaction that he/she had with the treatment. Physicians indicated the level of satisfaction with the patient's treatment. The 4- point scale consisted of the following responses: insufficient, moderate, good and very good. The combined percentage of good and very good responses by participants and physicians are reported."|ADM last [median 20.30 months]|Participants from the Safety Analysis Set, all participants who received at least one dose of BOTOX®, with data available.|||percentage of participants|||Number
2648278|NCT01686581|Secondary|Change From Baseline in the Number of Headache Days|At each visit, participants were asked to provide the number of headache days he/she experienced in the last month. A headache day was defined as 4 or more hours of continuous headache. A negative change from Baseline (less headache days) indicates improvement.|Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months]|Participants from the Safety Analysis Set, all participants who received at least one dose of BOTOX®, with data available at the given time-point.|||days||Full Range|Median
2648279|NCT01686581|Secondary|Change From Baseline in the Health State Score of the EQ-5D Questionnaire|The EQ-5D health state scale is a visual analog scale that ranges from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating a better state of health. Participants were asked to rate their health state on a drawn line that started at 0 and ended at 100. A positive change from baseline in the health state score indicates that the participant's health state has improved.|Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months]|Participants from the Safety Analysis Set, all participants who received at least one dose of BOTOX®, with data available at the given time-point.|||score on a scale||Full Range|Median
2648280|NCT01686581|Secondary|Change From Baseline in the EQ-5D Questionnaire Total Score|The EQ-5D consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) assessed by the participant using a 3-point scale: 1=no problems, 2=some problems and 3=extreme problems. The combination of levels from the 5 dimensions results in a health state code. The total score is calculated by converting the health state code into a score: start with score 1.000=[11111] (perfect health state), subtract 0.081 (constant) for any other state, subtract nothing for level 1 on any dimension, subtract appropriate level 2 or level 3 value for each dimension from a table of constants [Level 2: Mobility 0.069, Self-care 0.104, Usual activity 0.036, Pain/discomfort 0.123, Anxiety/depression 0.071] [Level 3: Mobility 0.314, Self-care 0.214, Usual activity 0.094, Pain/discomfort 0.386, Anxiety/depression 0.236], subtract 0.269 if any dimension has a level 3 problem. Higher numbers indicate better health. A positive change from Baseline indicates improvement.|Baseline (prior to first dose of BOTOX®) to ADM last [median 20.30 months]|Participant from the Safety Analysis Set, all participants who received at least one dose of BOTOX®, with data available at the given time-point.|||score on a scale||Full Range|Median
2648281|NCT01686581|Secondary|Change From Baseline in Migraine-Specific Quality of Life Questionnaire (MSQ) Score|The MSQ is a 14-item questionnaire to measure health-related quality-of-life attributed to migraine in the past 4 weeks. Each item is scored on a 6-point scale where: 1=none of the time to 6=all of the time. There are 3 dimensions: Role-function Restrictive (questions 1 to 7; score range 7 to 42), Role-function Preventive (questions 8 to 11; score range 4 to 24) and Emotional-function (questions 12 to 14; score range 3 to 18). The individual dimension scores were converted to a score of 0 to 100; the total score ranged from 0 to 300 with higher numbers representing a better quality of life. A positive change from baseline in the dimension scores and the total score indicates that quality of life has improved.|Baseline to Last Administration of BOTOX® (ADM last) [median 20.30 months]|Safety Analysis Set, all participants who received at least one dose of BOTOX®, with data available for analysis at the given time-point.|||score on a scale||Full Range|Median
2648282|NCT01686581|Primary|Percentage of Participants Who Visited Any Healthcare Professional (HCP)|The Baseline value included participants who had visited an HCP in the last 3 months prior to the baseline visit (first administration of Botox); the value for FU last included participants who visited an HCP since the second-to-last visit.|Baseline (previous 3 months prior to first dose of BOTOX®) to FU last [median 21.20 months]|Participants from the Safety Analysis Set, all participants who received at least one dose of BOTOX®, with data available for analysis at the given time-point.|||percentage of participants|||Number
2648283|NCT01686581|Primary|Mean Number of Days of Headache-related Hospital Admissions|The number of admission days is presented as the mean, normalized to a period of 90 days. The Baseline value included admissions during the last 3 months prior to the baseline visit (first administration of BOTOX®); the Last Follow-up value included admissions since the second-to-last visit.|Baseline (previous 3 months prior to first dose of BOTOX@) to FU last [median 21.20 months]|Participants from the Safety Analysis Set, all participants who received at least one dose of BOTOX®, who were hospitalized.|||days||Standard Deviation|Mean
2648284|NCT01686581|Primary|Percentage of Participants Admitted to the Hospital for Headache|The Baseline value included participants who had been admitted to the hospital for headache in the last 3 months prior to the baseline visit (first administration of BOTOX®); the Last Follow-up value included participants who been admitted to the hospital for headache since the previous visit.|Baseline (previous 3 months prior to first dose of BOTOX®) and Last Follow-up Visit (FU last) [median 21.20 months]|Participants from the Safety Analysis Set, all participants who received at least one dose of BOTOX®, with data available for analysis at the given time-point.|||percentage of participants|||Number
2648285|NCT01686568|Post-Hoc|EPA and DHA Concentrations in Adipose Tissue|Post hoc analyses were conducted to test whether EPA and DHA concentrations in subcutaneous abdominal adipose tissue in response to intervention explained variation in outcome measures of adipose tissue lipolysis insulin sensitivity and inflammatory markers post-intervention.|approximately after 6 months of treatment||||percentage of total free fatty acid||Standard Error|Mean
2648286|NCT01686568|Post-Hoc|EPA and DHA Concentrations in Plasma|Post hoc analyses were conducted to test whether EPA and DHA concentrations in plasma in response to intervention explained variation in outcome measures of adipose tissue lipolysis insulin sensitivity and inflammatory markers post-intervention.|approximately after 6 months of treatment||||percentage of total free fatty acid||Standard Error|Mean
2648287|NCT01686568|Secondary|Macrophage Crown-like Structures|Macrophages surrounding dying or dead adipocytes form crown-like structures (CLSs). One week after the pancreatic clamp study, participants were provided a standardized meal before an overnight fast. The next morning an abdominal adipose tissue biopsy was collected, and the samples were analyzed for adipocyte size. Immunohistochemistry was used to assess the number of crown-like structures per 10 images.|approximately after 6 months of treatment||||crown-like structures per 10 images||Inter-Quartile Range|Median
2648288|NCT01686568|Secondary|Immunohistochemistry Assessments of Macrophage Burden|One week after the pancreatic clamp study, participants were provided a standardized meal before an overnight fast. The next morning an abdominal adipose tissue biopsy was collected, and the samples were analyzed for adipocyte size. Immunohistochemistry was used to assess macrophage burden (total (CD68), M1 (CD14) and M2 (CD206) macrophages per 100 adipocytes).|approximately after 6 months of treatment||||macrophages per 100 adipocytes||Standard Deviation|Mean
2648289|NCT01686568|Secondary|Senescent Cells|Tissue burden of senescent cells, which was measured by staining for senescence-associated B-galactosidase activity and expressed as the number per 100 nucleated positive cells.|approximately after 6 months of treatment||||number positive cells/100 total cells||Standard Deviation|Mean
2648290|NCT01686568|Secondary|Insulin Concentration Needed to Suppress Palmitate Appearance Rates (IC50(Palmitate)f)|Sensitivity of adipose tissue lipolysis to insulin suppression, was calculated as the insulin concentration needed to suppress palmitate appearance rates (ie, flux) by 50% (IC50(palmitate)f).|approximately after 6 months of treatment|The number of subjects analyzed for this outcome measure for the placebo arm was 8 instead of 9. One subject did not have blood drawn for this outcome measure.|||µU/mL||Inter-Quartile Range|Median
2648291|NCT01686568|Secondary|Mitochondrial Function Determined by Muscle Biopsy at Baseline and 6 Month Follow up|Measurements of oxygen consumption in isolated mitochondria will be performed using a polarographic oxygen electrode.|Baseline, after 6 months of treatment||||pmol/s/mg tissue||Standard Error|Mean
2648292|NCT01686568|Secondary|Beta Cell Function From Insulin Secretion Following Ingestion of a Mixed Meal at Baseline and 6 Month Follow up|Following consumption of a mixed meal, beta cell function will be evaluated from serial measurements of C-peptide. C-peptide was measured using a two-side immunometric assay using electrochemiluminescence detection.|baseline, after 6 months of treatment||||nmol/L||Standard Error|Mean
2648293|NCT01686568|Primary|Insulin Sensitivity by Hyperinsulinemic-euglycemic Clamp at Baseline and 6 Month Follow up|A 2-stage insulin clamp will be performed with titration of dextrose to maintain euglycemia. D2 glucose will be infused to evaluate hepatic glucose production at baseline and in response to insulin. Hyperinsulinemic-euglycemic clamp technique: The plasma insulin concentration is acutely raised and maintained by a continuous infusion of insulin. Meanwhile, the plasma glucose concentration is held constant at basal levels by a variable glucose infusion. When the steady-state is achieved, the glucose infusion rate (GIR) equals glucose uptake by all the tissues in the body and is therefore a measure of tissue insulin sensitivity.|Baseline, after 6 months of treatment||||mg/kg FFM/min||Standard Error|Mean
2648294|NCT01686503|Secondary|Baseline Polio Neutralizing Antibody Titers|serum polio neutralizing antibody titers prior to the vaccine booster|first visit||||antibody titers||95% Confidence Interval|Geometric Mean
2648295|NCT01686503|Primary|Post Booster Polio Neutralizing Antibody Titers|Blood will be drawn at baseline and 4-6 weeks after receiving the vaccine booster dose. It will be spun down, and the serum frozen and stored at -80 degrees celsius. After all the participants have completed the study, all of the serum will be tested for polio neutralizing antibody titers.|4-6 weeks after receiving the vaccine||||antibody titers||95% Confidence Interval|Geometric Mean
2648296|NCT01686451|Other Pre-specified|Treatment Adherence at Week 4 in Simvastatin- and Xuezhikang-group|We counted the total number of pills that were dispensed to the participants at baseline and the total number of pills that were taken by participants at week 4.|Measured at baseline and week 4||||number of pills|||Number
2648297|NCT01686451|Other Pre-specified|Comparison of Safety Laboratory Testing (Cr) Between Simvastatin- and Xuezhikang-group|Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.|Measured at baseline and week 4||||mmol/L||Standard Deviation|Mean
2648298|NCT01686451|Other Pre-specified|Comparison of Safety Laboratory Testings (ALT,AST,CPK) Between Simvastatin- and Xuezhikang-groups|Fasting blood samples were collected at weeks 0 (randomization) and 4 (end of study) for clinical chemistry.|Measured at baseline and week 4||||U/L||Standard Deviation|Mean
2648300|NCT01686451|Primary|Comparison Between XueZhiKang and Simvastatin on Fatigue Scores|At baseline and week 4, the fatigue score was assessed by a fatigue questionnaire named as Fatigue Assessment Scale (FAS) which used 10-item fatigue measure with the fatigue score ranged from 10-50. The higher score was meaning of higher level of fatigue.|Measured at baseline and week 4||||units on a scale||Standard Deviation|Mean
2648301|NCT01686451|Secondary|Treatment Efficacy|Treatment efficacy was estimated on the basis of triglyceride (TG), total cholesterol (TC), high-density lipoprotein-cholesterol (HDL-C), as well as LDL-C levels obtained at baseline and week 4.|Measured at baseline and week 4||||mmol/L||Standard Deviation|Mean
2648302|NCT01686438|Secondary|Working Alliance Inventory - Short Revised (WAI-SR) - Goal Formation at 8 Weeks|The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.|2-8 weeks|patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)|||score on a scale||Standard Deviation|Mean
2648303|NCT01686438|Secondary|Working Alliance Inventory - Short Revised (WAI-SR) - Bond Formation at 8 Weeks|The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.|2-8 weeks|patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)|||score on a scale||Standard Deviation|Mean
2648304|NCT01686438|Secondary|Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 2 Scores|Self-administered measure of nightmare frequency in actual number of nightmares experienced over a 3 month period, and converted to yearly|baseline to 3 months (converted to yearly)|Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations), converted scores to yearly.|||number of nightmares||Standard Error|Least Squares Mean
2648305|NCT01686438|Secondary|Change From Baseline in Nightmare Frequency Questionnaire (NFQ) Part 1 Scores|Measure of nightmare frequency in number of nights with nightmares per year, scores converted to yearly.|baseline to 3 months, scores converted to yearly|Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations), converted scores to yearly.|||nights per year||Standard Error|Least Squares Mean
2648306|NCT01686438|Secondary|Charleston Psychiatric Outpatient Satisfaction Scale-VA Scores at 8 Weeks|Self administered questionnaire of person's satisfaction with care. Total scores range from 13 to 65, with higher scores indicating higher patient satisfaction. Scores reported from session 5.|2-8 weeks|patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)|||score on a scale||Standard Deviation|Mean
2648307|NCT01686438|Secondary|Working Alliance Inventory - Short Revised (WAI-SR) - Task Formation Scores at 8 Weeks|The WAI-SR is a 12 item self report of patient's perceived quality of interaction with practitioner. The scale focuses on task alliance, goal alliance, and bond formation. Items range from 1- never to 7- always. Scores range from 7-84. Higher scores indicate better alliance. Scores are reported from session 4.|2-8 weeks|patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)|||score on a scale||Standard Deviation|Mean
2648308|NCT01686438|Secondary|Change From Baseline in Work and Social Adjustment Scale Scores|A self-report scale of functional impairment attributable to an identified problem. Scores range from 0 - 40. Higher scores indicate increasing functional impairment.|baseline to 3 months|Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)|||units on a scale||Standard Error|Least Squares Mean
2648309|NCT01686438|Secondary|Change From Baseline in Medical Outcomes Study Short Form-12 (SF-12) Physical Component Score|self-administered validated health related quality of life questionnaire to assess functional outcomes. Scores range from 0 to 100. Higher scores indicate higher health function.|baseline to 3 months|patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)|||units on a scale||Standard Error|Least Squares Mean
2648310|NCT01686438|Secondary|Change From Baseline Medical Outcomes Study Short Form-12 (SF-12) Mental Component Score|Self-administered validated general health-related quality of life questionnaire to assess functional outcome. Scores range from 0 to 100. Higher scores indicate higher health function.|baseline to 3 months|Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)|||units on a scale||Standard Error|Least Squares Mean
2648311|NCT01686438|Secondary|Change From Baseline in Nightmare Distress Questionnaire Scores|Measure of intensity of the distress associated with a nightmare. Scores range from 0-52. Higher score indicates increased nightmare distress.|baseline to 3 month|Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)|||units on a scale||Standard Error|Least Squares Mean
2648312|NCT01686438|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index Addendum for PTSD (PSQI-A)|Measure of the sleep and dream disturbances often associated with PTSD. Scores range from 0-21. A higher score indicates higher frequency of disruptive nocturnal behaviors. Total score ≥ 4 can be used to indicate PTSD.|baseline to 3 months|Patients who attended over 3 sessions and had a non-missing 3 month visit (all available observations)|||units on a scale||Standard Error|Least Squares Mean
2648313|NCT01686438|Secondary|Change From Baseline Pittsburgh Sleep Quality Index (PSQI) Scores|Self-administered validated questionnaire measuring subjective sleep quality. Scores range from 0-21. Higher score indicates worse sleep quality. Total score < 5 is associated with good sleep quality.|baseline to 3 months|Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations)|||units on a scale||Standard Error|Least Squares Mean
2648314|NCT01686438|Secondary|Change From Baseline PTSD Checklist-Military (PCL-M) Scores|Self-administered validated questionnaire measuring PTSD severity. Scores range from 17-85. Higher scores indicate higher severity of symptoms.|baseline to 3 months|Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations|||units on a scale||Standard Error|Least Squares Mean
2648361|NCT01685684|Secondary|Weekly Changes in Pain Intensity|Weekly pain intensity scores were calculated based on averaged daily pain intensity scores (PI-NRS). Increases to the weekly change in pain intensity, correspond to increases in the PI-NRS scores (i.e. more pain).|Randomization Baseline and weekly through Week 12||||units on a scale||Standard Deviation|Mean
2648315|NCT01686438|Primary|Change From Baseline in Insomnia Severity Index Score|Self-report questionnaire used widely to assess presence of insomnia and its severity. Scores range from 0-28. Higher scores indicate increasing severity of insomnia.|Baseline to 3 months|Participants who attended over 3 sessions and had a non-missing 3 month visit (all available observations). This analysis was intended to only compare the two CBT-I groups for non-inferiority analysis.|||units on a scale||Standard Deviation|Least Squares Mean
2648316|NCT01686373|Primary|The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items).|The PNT includes 175 items and has a minimum score of 0 (zero items named correctly) and a maximum score of 175 (all items named correctly). The Naming 80 includes a portion of the trained treatment items (N=80) with a minimum score of 0 (zero items named correctly) and a maximum score of 80 (all items named correctly). For both scales, higher values represent better outcome. The average of two administrations of the PNT were added to the the average of two administrations of the Naming 80 for both time points. The outcome measure is the change in that value (averaged PNT + averaged Naming 80) from baseline to immediately post-treatment. Only two timepoints are used for this calculation: baseline and immediately post-treatment.|Immediately post-treatment||||PNT and Naming 80 score||95% Confidence Interval|Mean
2648317|NCT01686165|Secondary|Occurrence of Adverse Events and Serious Adverse Events|The proportion of patients with a given adverse event will be tabulated and the 95% confidence interval computed.|Up to 30 days after patient receives last dose of study drug||||Participants|||Count of Participants
2648318|NCT01686165|Secondary|Progression-free Survival|Will be estimated using a Kaplan-Meier estimate. The observed 2-year progression-free survival rate will be estimated (with a 95% confidence interval) from the Kaplan-Meier curve.|2 years||||Participants|||Count of Participants
2648319|NCT01686165|Primary|Overall Response|To document the overall response for patients with relapsed aggressive high-risk non-Hodgkin's lymphoma (NHL) treated with two cycles PXD-101 followed by one cycle of the Zevalin regimen.|Up to 5 years||||Participants|||Count of Participants
2648320|NCT01686165|Primary|Complete Response Rate|To document the complete response rate for patients with relapsed aggressive high-risk non-Hodgkin's lymphoma (NHL) treated with two cycles PXD-101 followed by one cycle of the Zevalin regimen.|Up to 5 years||||Participants|||Count of Participants
2648321|NCT01685996|Secondary|Nicotine Withdrawal Symptom Severity|Total Score from the Minnesota Nicotine Withdrawal Questionnaire (MNWQ), assessed at weekly visits. The MNWQ is a commonly-used 12-item Likert scale self-report measure of nicotine symptoms. Individual symptoms were rated from 0 (none) to 4 (severe) for each item and the Total score range was 0 - 48. Ratings were collected once weekly during study visits.|Past 24 hours||||units on a scale||Standard Deviation|Mean
2648322|NCT01685996|Primary|Percent Participants Abstinent From Smoking During Study Weeks 7-10|Biochemically-verified continuous smoking abstinence during weeks 7-10 of the study.|weeks 7-10||||Participants|||Count of Participants
2648323|NCT01685983|Primary|Percentage of Participants With Prostate-specific Antigen (PSA) Response|The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.|Baseline, Month 4|Analysis population included all participants who received at least 1 dose of abiraterone acetate.|||Percentage of participants|||Number
2648324|NCT01685983|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to 3 Years|Analysis population included all participants who received at least 1 dose of abiraterone acetate.|||Participants|||Number
2648325|NCT01685983|Secondary|Dehydroepiandrosterone Sulfate (DHEA-S)|Median DHEA-S concentration was reported at baseline and End-of-Treatment visit.|Baseline and End-of-Treatment Visit (up to approximately 3 years)|"Analysis population included all participants who received at least 1 dose of abiraterone acetate. n signifies those participants who were evaluated for this measure at the specified time point."|||micromole per liter||Full Range|Median
2648326|NCT01685983|Secondary|Serum Testosterone|Median serum testosterone concentration was reported at baseline and End-of-Treatment visit.|Baseline and End-of-Treatment Visit (up to approximately 3 years)|"Analysis population included all participants who received at least 1 dose of abiraterone acetate. n signifies those participants who were evaluated for this measure at the specified time point."|||nanomole per liter||Full Range|Median
2648327|NCT01685983|Secondary|Percentage of Participants With Objective Radiographic Response|Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|Up to 3 Years|Radiographic response-evaluable population included all participants who received at least 1 dose of abiraterone acetate, and had baseline and at least 1 on treatment tumor assessment.|||Percentage of participants|||Number
2648328|NCT01685983|Secondary|Time to PSA Progression|Time to PSA progression was measured as the time interval from the date of the first dose to the date of PSA progression as defined in the protocol-specific PSAWG criteria. For participants who have achieved a greater than or equal to (>=) 50% decrease from the baseline PSA, assessment of time to disease progression is when the PSA has increased 50% above the nadir and at a minimum of 5 nanogram/mililiter (ng/mL). For participants without a PSA decrease of this magnitude or without a decrease, the time for progression is calculated at the time a 25% increase from baseline PSA has been achieved.|Up to 28 Months|Analysis population included all participants who received at least 1 dose of abiraterone acetate.|||Days||95% Confidence Interval|Median
2648329|NCT01685983|Secondary|Overall Survival|Overall survival is defined as the time interval from the date of the first dose to the date of death due to any reason.|Up to 3 Years|Analysis population included all participants who received at least 1 dose of abiraterone acetate.|||Days||95% Confidence Interval|Median
2648332|NCT01685840|Secondary|Short Form-36 (SF-36) Vitality Subscale|SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.|Baseline, 3, 6, 12 and 24 months|"Number of participants analyzed is the number of participants who completed the questionnaire"|||units on a scale||Standard Deviation|Mean
2648333|NCT01685840|Secondary|Short Form-36 (SF-36) Physiological Functioning Subscale|SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.|Baseline, 3, 6, 12 and 24 months|"Number of participants analyzed is the number of participants who completed the questionnaire"|||units on a scale||Standard Deviation|Mean
2648334|NCT01685840|Secondary|Short Form-36 (SF-36) Social Functioning Subscale|SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.|Baseline, 3, 6, 12 and 24 months|"Number of participants analyzed is the number of participants who completed the questionnaire"|||units on a scale||Standard Deviation|Mean
2648335|NCT01685840|Secondary|Short Form-36 (SF-36) Mental Health Subscale|SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.|Baseline, 3, 6, 12 and 24 months|"Number of participants analyzed is the number of participants who completed the questionnaire"|||units on a scale||Standard Deviation|Mean
2648336|NCT01685840|Secondary|Short Form-36 (SF-36) General Health Subscale|SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.|Baseline, 3, 6, 12 and 24 months|"Number of participants analyzed is the number of participants who completed the questionnaire"|||units on a scale||Standard Deviation|Mean
2648337|NCT01685840|Secondary|Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score|This KCCQ overall score represents the mean of the following 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.|Baseline, 3, 6,12 and 24 months|"Number of participants analyzed is the number of participants who completed the questionnaire"|||units on a scale||Standard Deviation|Mean
2648338|NCT01685840|Secondary|EQ-5D Visual Analog Scale|The EQ-5D VAS records participants self-rated health status on a vertical (0-100) scale with higher scores indicating higher Health-Related Quality of Life, where 0 = worst imaginable health state and 100 = best imaginable health state.|Baseline, 3, 6, 12 and 24 months||||units on a scale||Standard Deviation|Mean
2648339|NCT01685840|Secondary|EQ-5D Health Index|The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score, from -0.59 (worst) to 1 (best).|Baseline, 3, 6, 12 and 24 months|"Number of participants analyzed is the number of participants who completed the questionnaire"|||units on a scale||Standard Deviation|Mean
2648340|NCT01685840|Secondary|Duke Activity Status Index (DASI)|The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).|Baseline, 3, 6, 12 and 24 months|"Number of participants analyzed is the number of participants who completed the questionnaire"|||units on a scale||Standard Deviation|Mean
2648341|NCT01685840|Secondary|Percentage of Patients With Moderate to Severe Depression|"Percentage of patients with moderate to severe depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D).~CES-D is a 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression. Moderate to severe depression is indicated by a score of 11 or higher."|Baseline, 3,6, 12 and 24 months|"Number of participants analyzed is the number of participants who completed the questionnaire"|||percentage of participants|||Number
2648342|NCT01685840|Secondary|Number of Hospitalizations for Recurrent Heart Failure|Recurrent Heart Failure Hospitalization|24 months||||hospitalizations|||Number
2648343|NCT01685840|Secondary|Number of Hospitalizations for First Heart Failure|First Heart Failure Hospitalization|24 months||||hospitalizations|||Number
2648344|NCT01685840|Secondary|CV Death|CV death by treatment arm|24 months||||deaths|||Number
2648345|NCT01685840|Secondary|Cumulative Morbidity|Days alive and not hospitalized for CV reasons|24 months||||days||95% Confidence Interval|Mean
2648346|NCT01685840|Secondary|All-cause Mortality|All-cause mortality by treatment arm|24 months||||deaths|||Number
2648347|NCT01685840|Primary|CV Death or Heart Failure Hospitalization|Composite of First Heart Failure Hospitalization or Cardiovascular Mortality|24 Months||||events|||Number
2648348|NCT01685801|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|"Adverse events (AEs) that started (or increased in severity) from first dose of study drug through completion of Follow-up were considered TEAEs, with exception that if an AE started during a Washout Period and was beyond 14 days from last dose date of preceding cycle, AE was considered as a Washout Period AE, and hence not TEAE. A TEAE was attributed to treatment in which it started or to the treatment in second cycling period of previous Crossover Period if it started during a Washout Period. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Data was to be reported by drug treatment for double-blind crossover period (Cycle 1 up to Washout Period 2) and open-label period."|From first dose of study drug through completion of follow-up visit (up to 26 weeks)|Safety set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies participant evaluable for this outcome measure.|||participants|||Number
2648611|NCT01683630|Primary|Age Adjusted Percentage of Participants With a Physician Visit Due to Any Diagnosis Within 30 Days of the Index Date of the Confirmed Influenza A and B Cases in the Province of Manitoba||up to 15 years||||Percentage of participants||95% Confidence Interval|Number
2648349|NCT01685801|Secondary|Open-label Period: Absolute Change From Open-label Baseline In Weight at Day 57|Data was to be reported for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Open-label Baseline, Open-label Day 57|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category."|||kilograms (kg)||Standard Deviation|Mean
2648350|NCT01685801|Secondary|Open-label Period: Absolute Change From Study Baseline In Sweat Chloride at Day 57|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Data was to be reported for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Study Baseline, Open-label Day 57|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category."|||millimole per liter (mmol/L)||Standard Deviation|Mean
2648351|NCT01685801|Secondary|Open-label Period: Absolute Change From Open-label Baseline In Lung Clearance Index (LCI) at Day 57|LCI is a measure of ventilation inhomogeneity that is derived from a multiple-breath washout test. The LCI was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity [FRC]) required to reduce end-tidal concentration of an inert gas to 1/40th of the starting value. Data was to be reported for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Open-label Baseline, Open-label Day 57|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category."|||ratio||Standard Deviation|Mean
2648352|NCT01685801|Secondary|Open-label Period: Absolute Change From Open-label Baseline In Percent Predicted Forced Expiratory Volume In 1 Second (FEV1) at Day 57|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Data was to be reported for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Open-label Baseline, Open-label Day 57|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category."|||Percent predicted of FEV1||Standard Deviation|Mean
2648353|NCT01685801|Secondary|Cycle 1 and Cycle 2: Absolute Change From Cycle Baseline In Lung Clearance Index (LCI) After 2 Weeks of Treatment|LCI is a measure of ventilation inhomogeneity that is derived from a multiple-breath washout test. The LCI was calculated as the number of lung volume turnovers (cumulative expired volume divided by the functional residual capacity [FRC]) required to reduce end-tidal concentration of an inert gas to 1/40th of the starting value. Data was to be reported for each cycle (Cycle 1 and Cycle 2) and as per drug treatment. Data was to be reported for each cycle (Cycle 1 and Cycle 2) and as per drug treatment, for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Cycle 1 baseline, Cycle 1 Day 15 (for Cycle 1 reporting arms); Cycle 2 baseline, Cycle 2 Day 15 (for Cycle 2 reporting arms)|"FAS population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category in each arm, respectively."|||ratio||Standard Deviation|Mean
2648354|NCT01685801|Primary|Cycle 1 and Cycle 2: Absolute Change From Cycle Baseline In Percent Predicted Forced Expiratory Volume In 1 Second (FEV1) After 2 Weeks of Treatment|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male participants 18 years and older and female participants 16 years and older. The Wang standard was used for male participants aged 12 to 17 years and for female participants aged 12 to 15 years. Data was to be reported for each cycle (Cycle 1 and Cycle 2) and as per drug treatment, for overall participants and as per genotype (residual function mutation and mRNA splice site mutation).|Cycle 1 baseline, Cycle 1 Day 15 (for Cycle 1 reporting arms); Cycle 2 baseline, Cycle 2 Day 15 (for Cycle 2 reporting arms)|"Full analysis set (FAS) population. Here, number of participants analyzed signifies participant evaluable for this outcome measure and n signifies participants who were evaluable for the specified category in each arm, respectively."|||Percent predicted of FEV1||Standard Deviation|Mean
2648355|NCT01685697|Primary|Difference in Percentage of Leak|Primary outcome: Difference in percentage of Leak|during mask ventilation in the first 5 minutes after birth||||% (percentage of mass leak)||Inter-Quartile Range|Median
2648356|NCT01685684|Secondary|Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ)|The Roland Morris Disability Questionnaire (RMDQ) is a self-administered questionnaire designed to assess physical disability caused by lower back pain. The RMDQ contains 24 sentences that subjects used to describe themselves when they have back pain. The RMDQ score is the total number of items checked which is from a minimum of 0 to a maximum of 24; the greater the score the grater the physical disability due to lower back pain.|Randomization Baseline and Week 12|The RMDQ was analyzed and presented as a change from Randomization Baseline to Week 12. Subjects' scores from Early Discontinuation visits were not included in this analysis.|||units on a scale||Standard Deviation|Mean
2648357|NCT01685684|Secondary|Changes in Quality of Life|Short Form 12 Question Health Survey version 2 (SF-12v2) is a self-report survey designed to measure general quality of life from the subject's point of view. The survey includes eight domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Physical (PCS) and mental component scores (MCS) are also calculated. Positive values indicate improvement from randomization baseline to Week 12.|Randomization Baseline through Week 12||||units on a scale||Standard Error|Mean
2648358|NCT01685684|Secondary|Patient Global Impression of Change (PGIC)|"The PGIC scale is a self-reported assessment that assesses a subject's impression of his/her change in activity limitations, symptoms, emotions, and the overall quality of life as they relate to his/her painful condition. The 7-point PGIC assessment includes very much improved, improved, a little improved, no change, a little worse, worse, and very much worse."|Screening Baseline through Week 12||||participants|||Number
2648363|NCT01685684|Secondary|Time-to-exit From the Study for All Causes|Survival analysis. Measure type indicated as 'Number' below represents 25% quartile, given that the median was not reached. These data are consistent with subject completion in the Participant Flow module.|Randomization Baseline through Week 12||||Days||95% Confidence Interval|Number
2648364|NCT01685684|Primary|Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase|The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).|Randomized Baseline through Week 12|One subject is missing all Average Weekly Pain Scores after Screening in the Oxycodone DETERx treatment group. This subject has been excluded from the analysis.|||units on a scale||Standard Error|Mean
2648365|NCT01685606|Secondary|To Evaluate the Rate of Dose Limiting Toxicities of HLA Haploidentical Peripheral Blood Pheresed Cellular Infusions.||30 days and 16 weeks after infusion||||participants|||Number
2648366|NCT01685606|Primary|Overall Response Rate of Cellular Immune Therapy With HLA Haploidentical Peripheral Blood Pheresed Cells in Patients With Relapsed/Refractory Hematological Malignancies.|"Criteria for AML and ALL (adapted from Cheson et al.20)~Complete remission (CR) is defined as the presence of all of the following~Peripheral blood~o No leukemic blasts present.~No extramedullary findings of leukemia or disappearance of such (i.e. CNS or soft tissue involvement)~Bone marrow~Cellularity >20% with baseline maturation.~No Auer rods~Less than 5% blast cells.~Complete blood counts and bone marrow normalization criteria must be met within one week of each other. Hematopoeitic recovery is an ANC > 1.0 x 109/L and platelet count > 100x109/L. No specific hemoglobin or hematocrit level is specified but the patient must be transfusion free.~Complete remission with incomplete recovery (CRi) is defined as the following:~Meets criteria for CR except~ANC < 1.0 x 109/L or platelet count < 100x109/L~Partial remission (PR).~• Must meet all criteria of a CR except that the bone marrow may contain 5-20% blasts."|8 weeks after infusion then 6 months after and every 4 months for approximately 2 years||||participants|||Number
2648367|NCT01685567|Secondary|Ipsilateral Stroke (Non-hierarchical)|Data on ipsilateral stroke 31-365 days post procedure will be collected to provide additional supportive evidence of the safety of the device.|31-365 days||||Participants|||Count of Participants
2648368|NCT01685567|Secondary|All Stroke (Non-hierarchical)|The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.|0 to 30 days||||Participants|||Count of Participants
2648369|NCT01685567|Secondary|All Myocardial Infarctions (Non-hierarchical)|The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.|0 to 30 days||||Participants|||Count of Participants
2648370|NCT01685567|Secondary|All Death (Non-hierarchical)|The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.|0 to 30 days||||Participants|||Count of Participants
2648371|NCT01685567|Primary|Hierarchical Composite of Stroke, Myocardial Infarction, and Death|The primary endpoint was a hierarchical composite of any stroke, myocardial infarction and death during a 30-day post-procedural period in the ITT (pivotal and extended enrollment) population comprised of subjects deemed to be high risk for complications from CEA.|30-day post-procedure||||Participants|||Count of Participants
2648372|NCT01685463|Secondary|Change Recruitment Curve (RC) Slope|Recruitment Curve (RC) Slope, measured at angle of slope|Baseline and 10 minutes after TMS||||ratio||Standard Deviation|Mean
2648373|NCT01685463|Secondary|Change in Cortical Silent Period|Cortical Silent Period is measured in seconds|Baseline and 10 minutes after TMS||||seconds||Standard Deviation|Mean
2648374|NCT01685463|Secondary|Change in Baseline of Resting Motor Threshold|Resting motor threshold (RMT); on a scale of 0-100 with 100 being most power given to enact a motor response|Baseline to 10 minutes after TMS||||units on a scale||Standard Deviation|Mean
2648375|NCT01685463|Primary|Cue Craving Rating|"The subject is asked to rate craving with 0 mm being  no craving at all and 100 mm representing the most craving I have ever had."|Change from Baseline in Craving rating 10 minutes after TMS||||scores on a scale||Standard Error|Mean
2648376|NCT01685437|Secondary|Change From Baseline in Penile Length|A negative value represents a reduction in measurement from baseline.|Baseline and Week 36|Efficacy is based on the mITT population.|||centimeters||Standard Deviation|Mean
2648377|NCT01685437|Secondary|A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score|"A composite responder is indicated by~a percent reduction from baseline in penile curvature greater than or equal to the threshold, and~a reduction from baseline in Peyronie's disease bother score greater than or equal to the threshold, or change in the overall sexual activity within the last 3 months to having vaginal intercourse from no vaginal intercourse at screening."|Week 36|Composite responder analysis is based on the intent-to-treat (ITT) population.|||participants|||Number
2648378|NCT01685437|Secondary|Change From Baseline in Penile Plaque Consistency|Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline in penile plaque consistency is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
2648379|NCT01685437|Secondary|Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)|Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.|Baseline and Week 36|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
2648380|NCT01685437|Secondary|A Responder Analysis Based on Subject Overall Global Assessment|Subject overall global assessment of Peyronie's disease score range -3 (much worse) to 3 (much improved). A score of 1 (improved in a small but important way), 2 (moderately improved), or 3 indicate a responder.|Week 36|Efficacy is based on the mITT population.|||participants|||Number
2648381|NCT01685437|Secondary|Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4|Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.|Baseline and Week 36|Efficacy is based on the mITT population; this population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater.|||units on a scale||Standard Deviation|Mean
2648382|NCT01685437|Secondary|Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ|Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
2648383|NCT01685437|Primary|Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)|Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.|Baseline and Week 36|Efficacy is based on the mITT population.|||units on a scale||Standard Deviation|Mean
2648384|NCT01685437|Primary|Percentage Change From Baseline in Penile Curvature|A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.|Baseline and Week 36|Efficacy is based on modified intent-to-treat (mITT) population.|||percentage of curvature change||Standard Deviation|Mean
2648385|NCT01685372|Other Pre-specified|Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination|Seroprotection (HAI>=1:40) and seroconversion (4-fold increase) together have been found to be a better predictor of vaccine effectiveness. Patients had to have both a 4-fold rise in HAI and have HAI>=40 to be counted|(1) T2 measured 14-45 days post-vaccination; (2) T3 measured June 1-Sept 30 post-vaccination (end-of season), following vaccination|For T3, only 4 participants in the high-dose group and 5 participants in the standard-dose group were analyzed due to loss-to-follow-up.|||Participants|||Count of Participants
2648386|NCT01685372|Other Pre-specified|Additional Measures of Immunogenicity in High Dose and Standard Dose Vaccinations|This secondary objective was included as exploratory and we plan to add additional analyses when funding is secured. There is no anticipated date when we will have this completed. (No immunogenicity studies have been done besides HAI.) For other immunogenicity: would compare results of blood draw #1 and #2 between the high-dose and standard-dose recipients for each patient group for any of the following: antibody avidity, microneutralization, T-cell interferon, T-cell IL-2, B-cell Immunoglobulin G (IgG) and B-cell Immunoglobulin A (IgA).|10-45 days post-vaccination|||||||
2648387|NCT01685372|Secondary|Number of Adverse Events Considered Definitely or Possibly Related to Vaccination Through Sept 30 of the Year Following Vaccination.|"Data gathered from the following~Safety data in 1st 14 days (safety surveys and safety diary)~Safety survey at day 30-45 regarding any unplanned health care visit or other AE during the 30 days after vaccine~On-going passive surveillance of adverse events (AEs)/serious adverse events (SAEs) throughout course of influenza season of enrollment~Chart review of each participant by PI through Sept 30 of the year following vaccine Data collection stopped in September following enrollment."|(1) Date of vaccine through day 30 post-vaccine; (2) Day 31 post-vaccine through September 30 of the year following vaccine|Data used included: active reporting through day 30, survey at end of season, and chart review for data through Sept 30 of the year following vaccination.|||number of AEs reported|||Number
2648388|NCT01685372|Secondary|Change in Disease Status From Vaccination Through June of the Following Year|"Evaluate disease status changes reported by subject on Questionnaire #2 as well as changes reported in clinic notes over the course of the influenza season. Subjects considered worse had worsening function of transplanted organ or complications related to underlying condition (e.g. dialysis) or new diagnosis of disease considered serious by PI."|up to 9 months post-vaccination|One subject in the high-dose group was originally on dialysis, but received a kidney transplant during the follow-up period. This subject was excluded from the analysis on change in baseline medical condition.|||Participants|||Count of Participants
2648389|NCT01685372|Secondary|Number of Participants Seroprotected at Timepoint 3 in High Dose and Standard Dose Vaccination Groups|Measure HAI on blood sample #3, drawn May-September following vaccination. Report number who still have HAI ≥ 1:40 in the high-dose and standard-dose groups.|at least 5 months post vaccination|Number of subjects seroprotected at T3 for each of the vaccine subtypes. 3 subjects in the HD group and 4 subjects in the SD group were lost-to-follow-up by T3 and not included in this analysis.|||Participants|||Count of Participants
2648390|NCT01685372|Secondary|Number of Subjects With Seroconversion From T1 to T2 in the High Dose and Standard Dose Vaccine Groups|HAI was measured on blood samples #1 and #2 for all subjects. Seroconversion is defined as a four-fold increase in antibody level between the high-dose and standard-dose recipients within each patient group was performed.|10-45 days post-vaccination|All participants had blood drawn at baseline (T1) and 10-45 days after vaccination (T2). Analysis was done for the 3 influenza subtypes in the trivalent influenza vaccine. The influenza vaccine was the same in 2013-2014 and 2014-2015.|||Participants|||Count of Participants
2648391|NCT01685372|Secondary|Number of Adverse Events Definitely or Possibly Related to Vaccination Reported Within 14 Days of Vaccination|Number of adverse events reported within the 14 days after vaccination by each subject within each patient group. Data collected from that reported in safety questionnaires and in Safety Diary that spanned the 14 days post-vaccination.|0-14 days after vaccination|All adverse events that may have been related are included in this analysis. Events considered not-related were excluded. More information on these AEs is included in the Adverse Events section. All AEs were reviewed by the study DSMB.|||number of AEs reported|||Number
2648392|NCT01685372|Primary|Number of Subjects Seroprotected at Timepoint 2 in High Dose and Standard Dose Vaccination Groups|"Measure hemagglutinin inhibition (HAI) on blood samples #2 for all subjects, which is the sample drawn at the peak of the immune response. Compare number of subjects who are seroprotected (reaching HAI ≥ 1:40) between the high-dose and standard-dose recipients.."|blood draw at 10-45 days post-vaccination|All participants had blood drawn before vaccination and at timepoint 2. The influenza vaccine had the same subtypes during the two season. Data were analyzed for the 3 subtypes contained in the trivalent vaccine, H1N1, H3N2, B (Yamagata).|||Participants|||Count of Participants
2648406|NCT01685242|Secondary|Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648393|NCT01685372|Primary|Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups|"Gathered data on influenza and influenza-like-illness during the influenza season for which the subject was vaccinated. Reported numbers of episodes of PCR-diagnosed influenza and rates of reported Influenza-Like-Illness (ILI) from Questionnaire #2 and also that were obtained from medical records. Data were categorized by the following:~Polymerase chain reaction (PCR)-proven diagnosis of influenza performed at Children's Hospital Colorado (CHC)~Diagnosis of influenza by non-PCR rapid-influenza test~Diagnosis of ILI (from questionnaire #2). [Centers for Disease Control (CDC) definition of ILI: Fever ≥ 100°F AND cough or sore throat in the absence of another known cause other than influenza for the illness.]"|up to 10 months after vaccination|Row 1: Number of influenza episodes diagnosed by PCR Row 2: Number of influenza episodes diagnosed by non-PCR rapid test Row 3: Number of influenza-like-illness (ILI) episodes reported by participants from the time of vaccination through June of the following year (end of flu season).|||episodes of illness|||Number
2648394|NCT01685320|Secondary|Time Required to Visualize the Glottis and Complete Oro-tracheal Intubation|Since the time needed for laryngoscopy and intubation could represent one of the major contributors to the stress response during these procedures, times to achieve the glottis visualization and to perform the entire intubation were recorded.|On average 20 seconds|We have utilized our previous in vitro study on manikin (Carassiti et al. Br J Anaesth 2012; 108: 146-151) as basis for the calculus of sample size in this research, considering 95% confidence interval (2-sided), power of 80%, ratio of sample size (Group B/Group A) = 1.|||seconds||Standard Deviation|Mean
2648395|NCT01685320|Primary|Force Applied and Pressure Distribution Upon the Blade of Laryngoscopes During Tracheal Intubation.|The pressure distribution exerted upon the tissues by the blade was measured (in Newton)through pressure film transducers put on the blade of both direct and indirect laryngoscopes, in order to compare the two devices.|Force measurement is referred to an average of 45 seconds in patients scheduled to undergo elective surgery under general anaesthesia|We have utilized our previous in vitro study on manikin (Carassiti et al. Br J Anaesth 2012; 108: 146-151) as basis for the calculus of sample size in this research, considering 95% confidence interval (2-sided), power of 80%, ratio of sample size (Group B/Group A) = 1.|||Newton||Standard Deviation|Mean
2648396|NCT01685242|Secondary|Tolerability of Study Medication at Visit 3A|Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|upon instillation, 1 minute and 2 minutes post instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648397|NCT01685242|Secondary|Nasal Composite Score at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||%participants with at least 1 nasal symp|||Number
2648398|NCT01685242|Secondary|Nasal Composite Score at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||%participants with at least 1 nasal symp|||Number
2648399|NCT01685242|Secondary|Nasal Congestion at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648400|NCT01685242|Secondary|Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648401|NCT01685242|Secondary|Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648402|NCT01685242|Secondary|Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648403|NCT01685242|Secondary|Nasal Pruritus at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648404|NCT01685242|Secondary|Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648405|NCT01685242|Secondary|Rhinorrhea at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648471|NCT01685021|Secondary|Number of Patients Who Develop Ant-MOR00208 Antibodies as a Measure of Immunogenicity||monthly, up to 7 months|Anti-MOR208 antibodies were not observed in any patients treated during this study.|||patients|||Number
2648407|NCT01685242|Secondary|Tearing at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648408|NCT01685242|Secondary|Tearing at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648409|NCT01685242|Secondary|Eyelid Swelling at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648410|NCT01685242|Secondary|Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648411|NCT01685242|Secondary|Chemosis at Onset of Action (15 Minutes)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648412|NCT01685242|Secondary|Chemosis at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648413|NCT01685242|Secondary|Episcleral Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648414|NCT01685242|Secondary|Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648415|NCT01685242|Secondary|Ciliary Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648416|NCT01685242|Secondary|Ciliary Redness at Duration of Action (8 Hours + 30 Minutes)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648417|NCT01685242|Primary|Conjunctival Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648418|NCT01685242|Primary|Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648419|NCT01685242|Primary|Ocular Itching at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648420|NCT01685242|Primary|Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-dose)|A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2648421|NCT01685229|Secondary|Post-operative Return to Normal Activity (RTNA)||2 weeks post treatment||||Days||Standard Deviation|Mean
2648422|NCT01685229|Secondary|Number of Medical Management Subjects Electing to Cross-over to Balloon Sinus Dilation Procedure||52 weeks||||Participants|||Number
2648423|NCT01685229|Secondary|Number of Subjects Requiring Revision for Subjects Electing BSD|A revision is defined as an endoscopic sinus surgery procedure on sinuses successfully dilated during index (BSD) procedure due to documented worsening of condition related to those sinuses after the index (BSD) procedure.|52 weeks||||Participants|||Number
2648424|NCT01685229|Secondary|Number of Sinus Infections||24 and 52 weeks||||Sinus infections||Standard Deviation|Mean
2648425|NCT01685229|Secondary|Number of Sinus-related Medical Care Visits||12 weeks, 24 weeks, 52 weeks post treatment||||Visits||Standard Deviation|Mean
2648426|NCT01685229|Secondary|Missed Days Work/School||12, 24 and 52 weeks post treatment||||Days||Standard Deviation|Mean
2648427|NCT01685229|Secondary|Change in Disease-specific Medication Usage||12, 24 and 52 weeks post treatment||||Medications||Standard Deviation|Mean
2648428|NCT01685229|Secondary|Change in SNOT-20|"The Sino-Nasal Outcome Test (SNOT-20) is a validated questionnaire consisting of 20 symptom-directed questions and quality of life and health utility assessments.~Scale values range from 0 (No Problem) to 5 (Problem as bad as it can be).~Lower score indicates greater improvement."|12 weeks, 24 weeks, 52 weeks post treatment||||Scores on a scale||Standard Deviation|Mean
2648429|NCT01685229|Secondary|Change in RSDI|"The Rhinosinusitis Disability Index (RSDI) is a 30-question survey which includes 3 individual subscales to measure physical, functional, and emotional scores as well as a total score. There is no specified recall period. Scale values are scored 0 (Never) to 4 (Always) and total score ranges from 0 (best) to 120 (worst). Subscores are summed to calculate a total score. Higher score indicates increased impact of sinus disease.~The Secondary Endpoint is comparison of change in patient-reported QOL as measured by RSDI total, physical, functional, and emotional sub-scores at 12, 24, and 52 weeks compared to baseline for subjects electing BSD versus medical management. Lower score indicates greater improvement (decreased impact of sinus disease)."|12, 24 and 52 weeks post treatment||||Scores on a scale||Standard Deviation|Mean
2648430|NCT01685229|Secondary|Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline|"The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey (during the past 8 weeks) used to evaluate surgical outcomes for CRS patients. The CSS asks 3 questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score. The symptom‐based section contains pain or pressure, nasal congestion or difficulty to breathe through the nose, and rhinorrhea or postnasal drip. The medication‐based section contains: antibiotics, prescription nasal sprays, and sinus medications in pill form. The duration of symptoms is scored 0 (7-8 Weeks) to 4 (0 Weeks), and a total score is normalized from 0 (worst) to 100 (best). The Secondary Endpoint is the comparison of change as measured by average CSS medication and sinusitis symptom sub-scores at 12, 24, and 52 weeks , and average total CSS score at 12 and 52 weeks for subjects electing BSD versus medical management. Higher score indicates greater improvement."|12, 24, and 52 weeks post treatment||||Scores on a scale||Standard Deviation|Mean
2648431|NCT01685229|Primary|Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline|"The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey (during the past 8 weeks) to evaluate surgical outcomes for CRS patients. The CSS asks three questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score.~The duration of symptoms is scored 0 (7-8 Weeks) to 4 (0 Weeks) and a total score is normalized from 0 (worst) to 100 (best).~The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects electing BSD versus medical management.~Change is assessed by using the Mean Change for the CSS total score at 24 weeks compared to baseline. (24-week CSS total score minus Baseline CSS total score).~Higher score indicates greater improvement."|24 weeks post treatment|Chronic Sinusitis Survey (CSS) Score Change from Baseline to 24 Weeks for BSD compared to MM|||Scores on a scale||Standard Deviation|Mean
2648432|NCT01685216|Secondary|Number of Participants Who Developed Anti-Velaglucerase Alfa Antibodies During The Study|Participants provided blood samples for measurement of anti-velaglucerase alfa antibodies in serum at baseline and approximately every 12 weeks during the treatment phase. Blood samples collected during the treatment phase were to be drawn prior to infusions. Analysis of anti-velaglucerase antibodies used a validated 3-tier immunoassay method (screening, confirmatory, and titer).|Baseline, Weeks 13, 25, 37 and 53|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).|||participants|||Number
2648433|NCT01685216|Secondary|Number of Participants Who Experienced a Treatment-Emergent Adverse Event|Adverse events (AEs) were monitored continuously throughout the study from the time the participant or participants parent/legal guardian signed the informed consent/assent (if applicable) until 30 days after the participant's last dose of study drug or at the end of study visit and/or until the event resolved or stabilized, or an outcome had been reached, whichever came first. Treatment-emergent adverse events (TEAEs) were defined as AEs which occurred on or after the time of the first infusion until 30 days after the participant's last study infusion. An infusion-related reaction is defined as an AE that 1) began either during or within 12 hours after the start of the infusion, and 2) was judged as possibly or probably related to study medication.|57 weeks|The Safety Analysis population, defined as all participants who received at least 1 study drug infusion (full or partial).|||participants|||Number
2648434|NCT01685216|Secondary|Number of Participants With Abnormal Neurological Status During The Study|Neurological symptoms were evaluated at regular intervals during the study and assessed on an individualized basis by a limited, age- and developmental stage-appropriate neurological examination adapted to suit the status of each participant. It was preferred that each neurological examination be performed by a neurologist with experience in assessment of neurological symptoms in patients with Gaucher disease and, if possible, the same neurologist (or designee) who evaluated a given participant at baseline performed the neurological examinations scheduled for that participant during the treatment phase and at the end of study visit.|Baseline, Weeks 13, 25, 37, and 53 or end of study|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).|||participants|||Number
2648435|NCT01685216|Secondary|Percent Change From Baseline to 12 Months (Week 51) in Normalized Spleen Volume Measured Using Magnetic Resonance Imaging (MRI)|Quantitative abdominal MRI was used to measure spleen volume. If sedation was necessary to perform an MRI and the investigator deemed that this would be an unwarranted risk to the participant, spleen volume could have been measured by ultrasound. Organ volume was measured by a single independent reviewer who was blinded to the participant identification and time point. The spleen size relative to body weight was determined using the corresponding body weight measured at the same visit. Change in spleen volume is presented as the normalized percentage of body weight. A negative change from baseline indicates that spleen volume decreased.|Baseline, Week 51|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).|||percent change||Standard Deviation|Mean
2648436|NCT01685216|Secondary|Percent Change From Baseline to 12 Months (Week 51) in Normalized Liver Volume Measured Using Magnetic Resonance Imaging (MRI)|Quantitative abdominal MRI was used to measure liver volume. If sedation was necessary to perform an MRI and the investigator deemed that this would be an unwarranted risk to the participant, liver volume could have been measured by ultrasound. Organ volume was measured by a single independent reviewer who was blinded to the participant identification and time point. The liver size relative to body weight was determined using the corresponding body weight measured at the same visit. Change in liver volume is presented as the normalized percentage of body weight. A negative change from baseline indicates that liver volume decreased.|Baseline, Week 51 or end of study|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).|||percent change||Standard Deviation|Mean
2648437|NCT01685216|Secondary|Change From Baseline to 12 Months (Week 53) in Platelet Count|Platelet count was measured at a central laboratory as part of the hematology panel. Baseline is the modified baseline platelet count, the average of the values from screening, baseline and Week 1/Day 1. A positive change from baseline indicates that platelet count increased.|Baseline, Week 53|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).|||platelets (x10^9)/L||Standard Deviation|Mean
2648438|NCT01685216|Primary|Change From Baseline to 12 Months (Week 53) in Hemoglobin Concentration|Hemoglobin concentration was measured as part of the hematology panel or measured separately when the hematology panel was not scheduled. Samples were measured by a central laboratory. Baseline is the modified baseline hemoglobin concentration, the average of the values from screening, baseline, and Week 1/Day 1. A positive change from baseline indicates that hemoglobin concentration increased.|Baseline, Week 53 or end of study|The Intent-to-Treat population, defined as all participants who received at least 1 study drug infusion (full or partial).|||g/dL||Standard Deviation|Mean
2648439|NCT01685203|Secondary|Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events|Treatment-emergent adverse events were defined as any event that began or worsened in severity after initiation of study drug through 30 days after the last dose of study drug.|From the start of study drug administration until 30 days after the last dose,16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.|All randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2648440|NCT01685203|Secondary|Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse.|Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.|Within 12 weeks after the last dose of study drug|All randomized participants who received at least 1 dose of study drug and completed treatment with HCV RNA < LLOQ at the final treatment visit.|||Percentage of participants||95% Confidence Interval|Number
2648441|NCT01685203|Secondary|Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure.|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), Day 3, and Treatment Weeks 1, 2 ,3 ,4, 6, 8, 10, and 12 for all participants and Treatment Weeks 16, 20 and 24 for Groups 7 and 8|All randomized participants who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2648442|NCT01685203|Primary|Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [<LLOQ]) 12 weeks after the last dose of study drug.|12 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2648443|NCT01685203|Secondary|Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [<LLOQ]) 24 weeks after the last dose of study drug.|24 weeks after the last actual dose of study drug|All randomized participants who received at least 1 dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2648444|NCT01685138|Secondary|Overall Survival (OS)|OS, defined as time from first dose of LDK378 to death due to any cause|Time from the date of first dose of LDK378 to the date of death due to any cause up to 5 years|The Full Analysis Set (FAS) consisted of all patients who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2648445|NCT01685138|Secondary|Progression-free Survival (PFS) Per Investigator and BIRC|PFS, defined as time from first dose of LDK378 to progression or death due to any cause, as assessed by investigator and BIRC assessments.|every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug up to 5 years|The Full Analysis Set (FAS) consisted of all patients who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2648446|NCT01685138|Secondary|Overall Intracranial Response Rate (OIRR) as Per BIRC|OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who have measureable disease in the brain at baseline by BIRC.|every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug up to 5 years|The set consisted of patients in the Full Analysis Set (FAS) who had measurable target lesions in brain at baseline by BIRC.|||Percentage of participants||95% Confidence Interval|Number
2648447|NCT01685138|Secondary|Overall Intracranial Response Rate (OIRR) as Per Investigator|OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who have measureable disease in the brain at baseline by investigator.|every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug up to 5 years|The set consisted of patients in the Full Analysis Set (FAS) who had measurable target lesions in brain at baseline by investigator.|||Percentage of participants||95% Confidence Interval|Number
2648448|NCT01685138|Secondary|Time to Response (TTR) as Per BIRC|TTR, calculated as the time from first dose of LDK378 to first documented response (CR+PR), by BIRC assessment. This was only on participants with confirmed CR or PR. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug up to 5 years|The set consisted of patients in the Full Analysis Set (FAS) who had confirmed complete response (CR) or partial response (PR) as assessed by BIRC.|||Months||Standard Deviation|Mean
2648449|NCT01685138|Secondary|Time to Response (TTR) as Per Investigator|TTR, calculated as the time from first dose of LDK378 to first documented response (CR+PR), by investigator. This was only on participants with confirmed CR or PR. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug|The set consisted of patients in the Full Analysis Set (FAS) who had confirmed complete response (CR) or partial response (PR) by investigator.|||Months||Standard Deviation|Mean
2648450|NCT01685138|Secondary|Disease Control Rate (DCR) as Per Investigator and BIRC|DCR per RECIST 1.1 is the percentage of participants with best overall response of CR, PR, stable disease (SD) or Non-CR/Non-PD. CR: Disappearance of all non-nodal target lesions. Also, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions that would qualify for PD. PD: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.|every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug up to 5 years|The Full Analysis Set (FAS) consisted of all patients who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2648451|NCT01685138|Secondary|Duration of Response (DOR) as Per BIRC|DOR, calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to any cause, by BIRC assessment per RECIST 1.1. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug up to 5 years|The set consisted of patients in the Full Analysis Set (FAS) who had confirmed complete response (CR) or partial response (PR) as assessed by BIRC.|||Months||95% Confidence Interval|Median
2648452|NCT01685138|Secondary|Duration of Response (DOR) as Per Investigator|DOR, calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to any cause, by investigator assessment per RECIST 1.1. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug up to 5 years|The set consisted of patients in the Full Analysis Set (FAS) who had confirmed complete response (CR) or partial response (PR) by investigator.|||Months||95% Confidence Interval|Median
2648453|NCT01685138|Secondary|ORR by Blinded Independent Review Committee (BIRC)|ORR per RECIST 1.1 calculated as the percentage of participants with a best overall response (OR) defined as complete response (CR) or partial response (PR) as assessed by BIRC. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug up to 5 years|The Full Analysis Set (FAS) consisted of all patients who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2648454|NCT01685138|Primary|Overall Response Rate (ORR) by Investigator Assessment|ORR per RECIST 1.1 calculated as the percentage of participants with a best overall response (OR) defined as complete response (CR) or partial response (PR) as assessed by the investigator. CR:Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|every 8 weeks (i.e. every 2 cycles; cycle = 28 days), starting from the first day of treatment with LDK378 until permanent discontinuation of study drug up to 5 years|The Full Analysis Set (FAS) consisted of all patients who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2648455|NCT01685073|Primary|Number of Participants With Cannabis Abstinence as Assessed by Urine Cannabis Testing|Qualitative urine cannabis testing outcomes of study participants; missing drop-outs presumed positive; Negative = THCCOOH <50ng/mL via EIA.|Week 12||||Participants|||Count of Participants
2648456|NCT01685073|Primary|Sleep Efficiency as Assessed by Percentage of Time Asleep While in Bed|Percentage of time asleep while in bed is measured using ambulatory polysomnography (PSG) equipment.|Week 1 of treatment|Sleep data was not obtained for 12 people in the zolpidem group and 14 people in the placebo group at Week 1, and could not be included in this analysis. These individuals dropped out of the study or were lost to follow-up by the time of data collection.|||percentage of time asleep while in bed||Standard Deviation|Mean
2648457|NCT01685060|Secondary|Overall Survival (OS)|OS, defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive.|6 cycles of 28 days up to 24 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib.|||Months||95% Confidence Interval|Median
2648458|NCT01685060|Secondary|Overall Intracranial Response Rate (OIRR) Per BIRC|OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who had measureable disease in the brain at baseline.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with measurable disease in brain at baseline selected by BIRC were included in this analysis.|||Percentage of participants||95% Confidence Interval|Number
2648634|NCT01683604|Secondary|Median Dose at Month 6||Month 6|FAS population. Here Number of participants analyzed = participants evaluable for the outcome measure.|||milligram per kilogram (mg/kg)||Full Range|Median
2648459|NCT01685060|Secondary|Overall Intracranial Response Rate (OIRR) Per Investigator|OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who had measureable disease in the brain at baseline.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with measurable disease in brain at baseline selected by Investigator were included in this analysis.|||Percentage of participants||95% Confidence Interval|Number
2648460|NCT01685060|Secondary|Progression-free Survival (PFS) Per BIRC|PFS, defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had no event or when the patient received any further anticancer therapy in the absence of disease progression, progression-free survival was censored at the date of last adequate tumor assessment.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib.|||months||95% Confidence Interval|Median
2648461|NCT01685060|Secondary|Progression-free Survival (PFS) Per Investigator|PFS, defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had no event or when the patient received any further anticancer therapy in the absence of disease progression, progression-free survival was censored at the date of last adequate tumor assessment.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib.|||months||95% Confidence Interval|Median
2648462|NCT01685060|Secondary|Time to Response (TTR) Per BIRC|TTR is the time from date of start of treatment to the first CR or PR observed which are confirmed afterwards.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) were included in this analysis.|||Months||Standard Deviation|Mean
2648463|NCT01685060|Secondary|Time to Response (TTR) Per Investigator|TTR is the time from date of start of treatment to the first CR or PR observed which were confirmed afterwards.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) were included in this analysis.|||Months||Standard Deviation|Mean
2648464|NCT01685060|Secondary|Disease Control Rate (DCR)|DCR was calculated as the percentage of patients with best overall response of CR, PR, SD, or non-CR non-PD (NCRNPD), per RECIST 1.1 by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. Non-CR/Non-PD (NCRNPD): refers to best overall responses that are neither CR nor PD per RECIST 1.1 criteria for patients with non-measurable disease only at baseline.|6 cycles of 28 days up to 24 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
2648465|NCT01685060|Secondary|Duration of Response (DOR) by BIRC|DOR, calculated as the time from the date of the first documented CR or PR to the first documented progression or death due to underlying cancer, by BIRC (Blinded Imaging Review Committee). CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|6 cycles of 28 days up to 24 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) per BIRC were included in this analysis.|||Months||95% Confidence Interval|Median
2648466|NCT01685060|Secondary|Duration of Response (DOR) by Investigator|DOR, calculated as the time from the date of the first confirmed CR or PR to the first documented progression or death due to any cause, by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|6 cycles of 28 days up to 24 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib. Only patients with confirmed complete response/partial response (CR/PR) per Investigator were included in this analysis.|||Months||95% Confidence Interval|Median
2648467|NCT01685060|Secondary|ORR Per Blinded Independent Review Committee (BIRC) Assessment|ORR (CR+PR) by BIRC is calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by BIRC. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|6 cycles of 28 days up to 24 weeks|The Full Analysis Set (FAS) consists of all patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
2648468|NCT01685060|Primary|Overall Response Rate (ORR) to LDK378 Per Investigator Assessment|ORR per RECIST 1.1 calculated as the percentage of patients with a best overall confirmed response defined as complete response or partial response (CR+PR) as assessed by investigator. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.|6 cycles of 28 days up to 24 weeks|Full Analysis Set (FAS) consisted of all patients who received at least one dose of ceritinib.|||Percentage of participants||95% Confidence Interval|Number
2648469|NCT01685047|Primary|Among Patients With an Appropriate ICD Therapy (Shock or ATP) for Ventricular Tachycardia or Fibrillation, the Number of Patients Who Have Characterized ST Segment Changes From Baseline Prior to the Therapy Was Calculated.||Until the end of follow up period|The other subjects enrolled in this study had no treated VT/VF events.|||participants|VT/VF events||Number
2648470|NCT01685021|Secondary|Safety Will be Evaluated by Assessing Adverse Events, Clinical Lab Data and Vital Signs, ECG, Physical Exam|Number of patients with treatment-emergent AEs|weekly, up to 7 months||||number of patients with 1 or more AE|||Number
2648474|NCT01685021|Secondary|Patients Response Duration Evaluation by Hematology, Bone Marrow Aspirates or Biopsy, CT|Two patients had a response to treatment. For one of the two patients a progression was recorded, the other patient was censored due to an AE. Conse quently, the planned Kaplan-Meier analyses of response duration and time to hematological relapse could not be calculated.|Throughout during study until progression, after each treatment cycle||||days|||Number
2648475|NCT01685021|Primary|Overall Response Rate (ORR)|"ORR= CR (Complete Remission) + PR (Partial Remission)~Antitumor activity of MOR00208"|Throughout during study until progression, after each treatment cycle||||participants|||Number
2648476|NCT01684943|Secondary|Multiplex PK: Average Number of Hypoglycemia Events Over the Last Month at Baseline Categorized According to Baseline Use of Insulin Analog Found to Have the Most Favorable PK Profile for Each Individual|Subjects with a difference in tmax between analogs will be categorized as follows: using insulin with best PK for them, using insulin with worst PK for them, or using insulin with intermediate PK for them. The average number of hypoglycemic events per month per group is reported.|1 month prior to study entry||||events in the month prior to study entry||Standard Deviation|Mean
2648477|NCT01684943|Secondary|Multiplex PK: Average Baseline HbA1c Categorized According to Baseline Use of Insulin Analog With Tmax < 60 Minutes vs. Use of an Insulin Analog With Tmax > 60 Minutes for Each Individual|Subjects with a difference in tmax between analogs will be categorized as follows: using insulin with tmax less than or equal to 60 minutes or using insulin with tmax > 60 minutes. The average A1c per group is reported.|Baseline||||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2648478|NCT01684943|Secondary|Multiplex PK: Count of Subjects With Difference in Tmax Between the Analog With Greatest and the Analog With the Least Value of Tmax That is > 25%||10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose||||Participants|||Count of Participants
2648479|NCT01684943|Secondary|Multiplex PK: Average Baseline HbA1c Categorized According to Baseline Use of Insulin Analog Found to Have the Most Favorable PK Profile for Each Individual|Subjects with a difference in tmax between analogs will be categorized as follows: using insulin with best PK for them, using insulin with worst PK for them, or using insulin with intermediate PK for them. The average A1c for each of the three categories is reported.|Baseline||||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2648480|NCT01684943|Primary|For Continuous Insulin Monitoring: Time to Maximum Plasma Insulin and Time to Maximum Continuous Insulin Monitoring Insulin||10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose|Only 2 of the 4 experiments conducted under the Continuous Insulin Monitoring sub-study protocol produced usable data for analysis. Those two experiments are both reported here|||minutes|||Number
2648481|NCT01684943|Primary|For Multiplex PK Profiling: Aggregate Mean Difference in Tmax Between the Analog With Greatest and the Analog With the Least Value of Tmax for Individuals|The average difference in tmax between lispro and aspart in all participants|10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300 minutes after dose||||minutes||Standard Deviation|Mean
2648482|NCT01684930|Secondary|Change in Angiogenesis|Gastrocnemious muscle biopsy will be performed to measure the number of capillaries per fibre as a marker of change in angiogenesis between groups|Baseline and 16 weeks|Participants who had a gastrocnemius muscle biopsy with enough tissue to analyze.|||capillaries per fibrer||Standard Deviation|Mean
2648483|NCT01684930|Secondary|Change In Vascular Function (BAFMD)|Vascular Function is measured as Brachial artery flow-mediated dilation (BAFMD). BAFMD is a measure of change in artery diameter after a stimulus .|Baseline and 16 weeks|participants with analyzable data|||% dilation||Standard Deviation|Mean
2648484|NCT01684930|Secondary|Change In Claudication Onset Time|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of claudication onset time.|Baseline and 16 weeks||||seconds||Standard Deviation|Mean
2648485|NCT01684930|Secondary|Change in Functional Ability|Six-Minute Walk test. This test simple and practical assessment of functional capacity. The test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes. The test is self-paced and assesses the submaximal level of functional capacity. The subjects choose their own intensity and are allowed to stop and rest if necessary during the test.|Baseline and 16 Weeks||||feet||Standard Deviation|Mean
2648486|NCT01684930|Primary|Change In Time To Exhaustion|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of total time to exhaustion.|Baseline and 16 weeks||||seconds||Standard Deviation|Mean
2648487|NCT01684930|Primary|Change in Exercise Capacity: VO2peak (Maximal Oxygen Consumption)|Exercise capacity will be assessed using a maximal cardiopulmonary exercise (CPX) test with expired gas analysis, for determination of peak oxygen consumption, claudication onset time and peak walking time.|Baseline and 16 Weeks|All participants who completed study.|||ml/kg/min||Standard Deviation|Mean
2648488|NCT01684917|Secondary|Body Weight||Baseline, 12 weeks||||kg||Standard Error|Mean
2648489|NCT01684917|Secondary|Genome Integrity (DNA Methylation and Telomere Length)||12 weeks|Data not collected||||||
2648490|NCT01684917|Secondary|Changes in Adipocyte Morphology|Percentage Change in total adipose tissue assessed by MRI|12 weeks|1 missing data in diet group|||percentage change||Standard Error|Mean
2648491|NCT01684917|Secondary|Body Composition|Body Composition assessed by BMI|Baseline, 12 weeks||||kg/m^2||Standard Error|Mean
2648492|NCT01684917|Primary|Metabolomic Biomarker Discovery - Changes in Blood Plasma Cholesterol|"Changes in blood plasma cholesterol in mg/dL- baseline to 12 weeks, after treatment. Statistical Analysis was performed only for the Diet Arm/Group."|Baseline, 12 weeks||||mg/dL||Standard Error|Mean
2648493|NCT01684917|Primary|Insulin Sensitivity|"Glucose Infusion rate assessed by the euglycemic hyperinsulinemic clamp. Insulin Sensitivity assessment was only performed in the Exercise and Exercise, Control groups. No data were collected for this Outcome from the remaining groups."|Baseline, 12 weeks|No data available for diet and diet-control group|||mg/kg/min||Standard Error|Mean
2648635|NCT01683604|Secondary|Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs||Baseline|FAS population.|||percentage of participants|||Number
2648494|NCT01684878|Secondary|Part 2: Overall Survival|Overall survival was defined as the time from randomization into Part 2 of the trial until death from any cause|Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)|ITT Population included all randomized participants in the group to which they were randomly assigned (‘as randomized’ analysis)|||months||95% Confidence Interval|Median
2648495|NCT01684878|Secondary|Part 2: Percentage of Participants With Adverse Events (AEs)|An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment)|Safety population included all participants who had received at least 1 dose of pertuzumab, pertuzumab-placebo, or chemotherapy.|||percentage of participants|||Number
2648496|NCT01684878|Secondary|Part 2: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (QLQ) of Core 30 (C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale [1 'very poor' to 7 'Excellent']). Scores averaged, transformed to 0-100 scale; for functional scores, a higher score represents a better level of functioning. For symptom scores, a higher score represents a more severe level of symptoms. For the global health status scores, a higher score represents a better quality of life.|Baseline (assessed at baseline and every 9 weeks from randomization until disease progression)|ITT population included all randomized participants in the group to which they were randomly assigned (‘as randomized’ analysis).|||units on a scale||Standard Deviation|Mean
2648497|NCT01684878|Secondary|Part 2: Progression-free Survival (PFS) Assessed by the Investigator|PFS (Investigator-assessed) is defined as the time from randomization, until disease progression according to RECIST v1.1 including death or MBO, whichever occurs first. Censoring is based on the last tumor assessment. If no tumor assessment post baseline, then censoring is at day 1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)|ITT Population included all randomized participants in the group to which they were randomly assigned (‘as randomized’ analysis)|||months||95% Confidence Interval|Median
2648498|NCT01684878|Secondary|Part 1: PFS Assessed by the Investigator|PFS as assessed by Investigator was defined as the time from first dose of pertuzumab or chemotherapy in Part 1 of the trial, until disease progression according to RECIST version 1.1, symptomatic deterioration or death from any cause, whichever occurs first. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Participants were censored at the last tumor assessment. Participants who have no tumor assessments after baseline and who were still alive will be censored at 1 day.|Approximately 28 months (assessed at screening and every 9 weeks from randomization until disease progression)|All Treated population included all participants enrolled and treated in Part 1 of the study (‘as treated’ analysis) and who had received at least 1 dose of pertuzumab or chemotherapy.|||months||95% Confidence Interval|Median
2648499|NCT01684878|Secondary|Part 2- Objective Response Rate (ORR)|ORR was defined as the number of participants with BOR of CR or PR recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)|ITT population with measurable disease at baseline.|||percentage of participants||95% Confidence Interval|Number
2648500|NCT01684878|Secondary|Part 1- Objective Response Rate (ORR)|ORR was defined as the number of participants with best overall response (BOR) of complete response (CR) or partial response (PR) recorded from the start of treatment, until the end of treatment. BOR documented as confirmed CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeter (mm). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Approximately 28 months (assessed at baseline and every 9 weeks from randomization until disease progression)|All Treated participants with measurable disease at baseline.|||percentage of participants|||Number
2648501|NCT01684878|Primary|Part 2: Progression Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Including Malignant Bowel Obstruction (MBO)|PFS (IRC-Assessed) was defined as the time from randomization into Part 2 of the trial until progressive disease (PD), MBO or death from any cause, whichever occurred first per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. PD could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions.|Approximately 44 months (assessed at screening and every 9 weeks from randomization until disease progression)|ITT Population was defined as all randomized participants in the group to which they were randomly assigned (‘as randomized’ analysis).|||months||95% Confidence Interval|Median
2648502|NCT01684878|Primary|Part 1: Percentage of Participants With Adverse Events (AEs)|An AE can be any unfavorable and unintended sign (including an abnormality laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Approximately 28 months (assessed at screening, baseline until 28 days after the last dose of study treatment)|All Treated population included all participants enrolled and treated in Part 1 of the study (‘as treated’ analysis) and who had received at least 1 dose of pertuzumab or chemotherapy.|||percentage of participants|||Number
2648505|NCT01684839|Primary|Static 2-point Discrimination Test|The Static 2-point Discrimination Test determined the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines was used to stratify the 2PD measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm). The test points were at the center of the radial or ulnar portion of the finger pulp (i.e., injury side). Each area was tested 3 times with a discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4mm as a limit of 2PD and consider this normal. The measurements were performed at a single time point at the final follow up.|20-26 months postoperatively||||mm||Standard Deviation|Mean
2648506|NCT01684826|Other Pre-specified|Radiation Dose Measurements: Air Kerma (AK)|Percentage of change of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper.|Participants were followed for the duration of the procedure|all patients with recorded dose information and images for both angiograms were included (n=39)|||percentage of dose change||Standard Deviation|Mean
2648507|NCT01684826|Secondary|Radiation Dose Measurements: Dose Area Product (DAP)|Percentage of change of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper.|Participants were followed for the duration of the procedure|all patients with recorded dose information and images for both angiograms were included (n=39)|||percentage of dose change||Standard Deviation|Mean
2648508|NCT01684826|Primary|Image Quality|"Overall proportion where diagnostic image quality of ClarityIQ is scored equal or better compared to AlluraXper by the blinded readers. Reading is performed by simultaneous visual comparison of the image quality of AlluraXper and ClarityIQ by multiple blinded reviewers.The images are presented in a randomized order.~The hypothesis is that the overall proportion where diagnostic image quality of ClarityIQ is scored equal or better is ≥ than 0.80. Combined for all raters, the lower bound of the one-sided 95% CI (lower bound of the two-sided 90% CI)is used."|1 day|All patient with recorded dose information and images for both angiograms were used.|||proportion of readers||90% Confidence Interval|Mean
2648509|NCT01684748|Other Pre-specified|Collagen Gene Expression in Skeletal Muscle (Change Over Time)|RNA extraction and quantification were determined using an RNeasy Mini Fibrous Kit and DNase I treatment (Qiagen, Valencia, CA, USA) in accordance to the manufacturer's directions for mRNA extraction. Quantitative real-time polymerase chain reaction (qRT-PCR) measured the expression of collagen III using an ABI PRISM 7900 Sequence Detection System instrument and TaqMan Universal PCR Master Mix according to the manufacturer's instructions (Applied Biosystems, Foster City, CA, USA). Relative gene expression levels were determined using the number of cycles necessary to reach threshold and results were normalized to cyclophilin B RNA levels.|Baseline testing to post-testing after 8-week intervention|Results are reported for the Olmesartan Medoxomil intervention only; there was insufficient RNA yield for the majority of participants during the no drug treatment. Only 7 of the 16 study participants who participated in the study measurements had sufficient data to analyze the pre- and post-intervention skeletal muscle biopsy tissues.|||Arbitrary unit (AU)||Standard Error|Mean
2648510|NCT01684748|Primary|Insulin Sensitivity by Intravenous Glucose Tolerance Testing (Change Over Time)|Data collected from the intravenous glucose tolerance tests included blood concentrations of glucose and insulin. Glucose was measured immediately on a YSI glucose analyzer and insulin was measured via ELISA colormetric kits once all study samples were collected. To analyze changes in insulin sensitivity, the MINMOD software was used. The MINMOD software uses Bergman's minimal model to determine insulin sensitivity during an intravenous glucose tolerance test. Both glucose and insulin values were inserted at each timepoint collected (33 in total over the 3-hour protocol) and the software was run to generate the insulin sensitivity value at baseline and post-test. This information was then used to calculate the change of insulin sensitivity from baseline to post-testing after each 8-week intervention.|Baseline testing to post-testing after 8-week intervention|Results of insulin sensitivity by intravenous glucose tolerance (IVGTT) testing are reported per intervention (Olmesartan Medoxomil and No drug). Only 10 of the 16 study participants who participated in all or some of the study measurements opted to complete or had sufficient data to analyze for each pre- and post-intervention (4 total) IVGTT.|||mu/L/min||Standard Deviation|Mean
2648511|NCT01684592|Secondary|NicCheck Test Results for Cotinine Level From Infant Urine|"Infant urine was collected at 6 months postpartum using the cotton roll method of urine collection. Cotinine was measured with NicCheck I Test Strips that determine the urinary concentration of nicotine and its metabolites based on a colorimetric reaction. The test strip is dipped into participant's urine and changes color (varying shades of pink) in the presence of cotinine. Cotinine level is determined by matching the test strip with a color chart provided by the manufacturer. The intensity of color on the strip at the end of 15 minutes may be compared to those on the color chart, to differentiate between low (score 1-6) versus high (score 7-14) nicotine consumption. Absence of a color is considered a negative result (score 0). Based on comparison with gas chromatography urine cotinine values, individuals with cotinine values of 200 ng/mL and above are classified as smokers."|6 months postpartum||||units on a scale||Standard Deviation|Mean
2648512|NCT01684592|Secondary|Times Mother Smoked in the Room With Infant|Based on the number of days of smoking in the same room with infant in the past 90.|Baby's birth to 6 months postpartum|Only current smokers responded to this question|||number of days smoked||Standard Deviation|Mean
2648513|NCT01684592|Secondary|Times Mother Smoked While Breastfeeding|Based on the days of smoking while breastfeeding (or within 30 minutes of breastfeeding) times the frequency of use on day.|Baby's birth to 6 months postpartum|Only 7 women reported having breastfed at 6 month postpartum|||times smoked in past 90 days||Standard Deviation|Mean
2648514|NCT01684592|Secondary|Past 90-day Tobacco Use|Self-reported number of days smoked tobacco in past 90 days.|6 months postpartum||||days||95% Confidence Interval|Mean
2648515|NCT01684592|Secondary|Past 90-day Tobacco Use|Self-reported number of days smoked in past 90 days|3 months postpartum||||days||95% Confidence Interval|Mean
2648516|NCT01684592|Secondary|Number of Tobacco Products Per Day|Self-reported number of tobacco products smoked per day|3 months postpartum||||tobacco products||95% Confidence Interval|Mean
2648517|NCT01684592|Primary|Number of Tobacco Products Per Day|Self-reported number of tobacco products smoked per day|6 months postpartum||||tobacco products||95% Confidence Interval|Mean
2648518|NCT01684566|Secondary|Duration of Oral Mucositis, Per Protocol Population|Duration of oral mucositis during the treatment period of 28 Days. Oral mucositis is graded according to the 5-point oral mucositis WHO scale Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible|28 days|Per Protocol (PP). There were 9 patients in the episil +SOC group and 12 patients in the SOC group who had no data for duration of oral mucositis|||Days||Standard Deviation|Mean
2648519|NCT01684566|Secondary|Occurence of Oral Mucositis, Per Protocol Population|"Occurrence of oral mucositis (ie, oral mucositis defined as WHO (World Health Organisation) oral toxicity scale grade 0-4~A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|Per Protocol (PP)|||participants|||Number
2648520|NCT01684566|Primary|WHO (World Health Organisation) Oral Mucositis Severity Score During 28 Days of Treatment, Per Protocol Population|"Summary of WHO (World Health Organisation) Oral Toxicity Scores AUC Over the 28-Day Period Per protocol population.~A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|Per Protocol (PP) without Last observation carried over(LOCF)|||score||Standard Deviation|Mean
2648521|NCT01684566|Secondary|Hospital Stay, Days|Duration of hospital stay (time from admission to discharge)|28 days|Intention to treat (ITT) Hospital stay, days|||Days||Standard Deviation|Mean
2648522|NCT01684566|Secondary|Oral Mucositis Assessment Scale (OMAS)|"Summary of Oral Mucositis Assessment Scale (OMAS) Ulceration and Erythema Scores Extent of ulceration (grade 0-3) and severity of erythema (grade 0-2) according to the OMAS (Oral Mucositis Assessment Scale) assessed by a dental practitioner twice-weekly over the 28-day study period.~The extent of ulceration was rated as follows:~0 no lesion~1 cm2~1-3 cm2~>3 cm2~The severity of erythema was assessed as follows:~0 none~not severe~severe"|28 days|Intention to treat (ITT) Ulceration and Erythema.OMAS was only performed in sites were a dentist was available therefore lower numbers in the analysis.|||score||Standard Deviation|Mean
2648523|NCT01684566|Secondary|Oral Mucositis Daily Questionnaire (OMDQ)|OMDQ (Oral Mucositis Daily Questionnaire) scale was used to measure Overall Mouth and Throat Soreness This was scored from 0=no soreness to 10=worst possible soreness.|28 days|Intention to treat(ITT) OMDQ AUC over time. Not all patients reported data from OMDQ therefore there is lower number of patients in this analysis.|||units on a scale||Standard Deviation|Mean
2648524|NCT01684566|Secondary|Duration of Oral Mucositis, Intention to Treat Population|"Duration of oral mucositis during the treatment period of 28 Days. Oral mucositis was graded according to WHO 5 Point grading scale on a daily basis.~Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|ITT (Intention to treat). There were13 patients in the episil +SOC group and 12 patients in the SOC group who had no data for duration of oral mucositis|||Days||Standard Deviation|Mean
2648525|NCT01684566|Secondary|Occurrence of Oral Mucositis|"Occurrence of oral mucositis (ie, oral mucositis defined as WHO (World Health Organization) oral toxicity scale grade 0-4.~A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|Intention to treat (ITT)|||participants|||Number
2648526|NCT01684566|Primary|WHO (World Health Organisation) Oral Mucositis Severity Score During 28 Days of Treatment, Intention to Treat Population|"Summary of WHO (World Health Organisation) Oral Toxicity Scores Area under the curve (AUC) over the 28-Day Period ITT Populations.~A higher score represents a more severe oral mucositis Grade 0 No mucositis Grade 1 Soreness ± erythema, no ulceration Grade 2 Erythema, ulcers. Patients can swallow solid diet Grade 3 Ulcers, extensive erythema. Patients cannot swallow solid diet Grade 4 Oral mucositis to the extent that alimentation is not possible"|28 days|Intention to treat (ITT) and Last observation carried forward (LOCF)|||score||Standard Deviation|Mean
2648527|NCT01684436|Primary|Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye|A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye.|Week 3|All patients who completed the study|||picogram/milliliter/millimeter(pg/ml/mm)||Standard Deviation|Mean
2648528|NCT01684436|Secondary|Dry Eye Questionnaire Irritation Score|Severity of dry eye irritation is rated by the patient using a visual analogue scale (VAS). Patients put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms. The higher the score, the more severe the symptoms.|Week 0 (Baseline), Week 3|All patients who completed the study|||Millimeters (mm)||Standard Deviation|Mean
2648529|NCT01684436|Secondary|Schirmer's Test Score|The Schirmer's Test measures the rate of tear secretion by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye.|Week 0 (Baseline), Week 3|All patients who completed the study|||Millimeters (mm)||Standard Deviation|Mean
2648530|NCT01684436|Secondary|Tear Film Break-up Time (TBUT)|TBUT is defined as the time to initial breakup of the tear film following a blink. The longer it takes, the more stable the tear film.|Week 0 (Baseline), Week 3|All patients who completed the study|||Seconds||Standard Deviation|Mean
2648636|NCT01683604|Primary|C-Reactive Protein (CRP) at Baseline|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline|FAS population.|||milligrams per liter (mg/L)||Standard Deviation|Mean
2648531|NCT01684436|Secondary|Corneal Fluorescein Staining Score in the Study Eye|The cornea is evaluated following ocular administration of fluorescein stain in the study eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The cornea is divided into 5 regions. Each region is scored according to the extent of staining, with scores ranging from 0 to 4 points: 0=non-staining to 4=regional whole staining of the cornea with 0.5 unit intervals. The higher the staining score, the worse the dry eye condition.|Week 0 (Baseline), Week 3|All patients who completed the study|||Scores on a Scale||Standard Deviation|Mean
2648532|NCT01684436|Primary|Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye|A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye.|Week 0 (Baseline)|All patients who completed the study|||picogram/milliliter/millimeter(pg/ml/mm)||Standard Deviation|Mean
2648533|NCT01684423|Secondary|Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points|Geometric and percentage geometric coefficient of variation (%CV) were reported.|0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31|Pharmacokinetic analysis set (N= 42) included all subjects with at least one pharmacokinetic sample in accordance with the pharmacokinetic sampling strategy.|||microgram per liter (mcg/L)||Geometric Coefficient of Variation|Geometric Mean
2648534|NCT01684423|Secondary|Anti-factor Xa Values at Specified Time Points|The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.|0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31|Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.|||microgram per liter (mcg/L)||Standard Deviation|Mean
2648535|NCT01684423|Secondary|Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points|The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway.|0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31|Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.|||seconds||Standard Deviation|Mean
2648536|NCT01684423|Secondary|Change From Baseline in Prothrombin Time at Specified Time Points|Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.|0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31|Pharmacodynamic analysis set (N=42) included all subjects with at least one blood sample for clotting parameters in accordance with the pharmacodynamic sampling strategy.|||seconds||Standard Deviation|Mean
2648537|NCT01684423|Secondary|Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden|The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. Asymptomatic deterioration in thrombotic burden was documented by the appropriate imaging test and the results were classified as normalized, improved, no relevant change, deteriorated, not evaluable or not available.|Repeat imaging at the end of the 30 day treatment period|Full analysis set|||Participants|||Number
2648538|NCT01684423|Secondary|Number of Subjects With Symptomatic Recurrent Venous Thromboembolism|The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence of venous thrombosis was documented by the appropriate imaging test.|From start of study drug administration until end of the 30-day treatment period|Full analysis set|||Participants|||Number
2648539|NCT01684423|Primary|Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events|"Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and:~associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or~leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or~occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or~contributing to death.~Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with:~medical intervention, or~unscheduled contact (visit or telephone call) with a physician, or~cessation (temporary) of study treatment, or~discomfort for the child such as pain or~impairment of activities of daily life (such as loss of school days or hospitalization)."|From start of study drug administration until end of the 30-day treatment period|Full analysis set. Data was evaluated only for subjects who received active study medication.|||Participants|||Number
2648540|NCT01684410|Other Pre-specified|Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 3|FVC conducted before and after inhalation of the investigational product|3 weeks|Safety Population: included all subjects who received any dose of Investigational Product (included those withdrawn from treatment for any reason)|||percent||Standard Deviation|Mean
2648541|NCT01684410|Other Pre-specified|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3|FEV1 conducted before and after inhalation of the investigational product at study visits.|3 weeks|Safety Population: included all subjects who received any dose of Investigational Product (included those withdrawn from treatment for any reason)|||percent||Standard Deviation|Mean
2648542|NCT01684410|Primary|Adverse Events|adverse event frequency|3 weeks|Safety Population: included all subjects who received any dose of IP (included those withdrawn from treatment for any reason)|||percentage of participants|||Number
2648543|NCT01684215|Secondary|Presence of Tumor Tissue Biomarkers- Estrogen Receptor (ER) H-Score, Retinoblastoma (Rb) H-Score, B-cell Lymphoma-1 (BCL-1) H-Score, P16 H-Score: Phase 2|Tumor tissue biomarkers ER, Rb, BCL-1 and P16 were analyzed to investigate possible associations with resistance or sensitivity to treatment with study drugs and were selected based on their known relevance to mechanisms involved in cell cycle regulation. Number of participants with positive ER (H-Score), Rb (H-Score), BCL-1 (H-Score) and P16 (H-Score) tumor tissue biomarkers were reported. The H-score is a method of assessing the extent of nuclear immunoreactivity, applicable to steroid receptors.|Baseline (Day 1)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||participants|||Number
2648652|NCT01683526|Primary|First Pass Success Rate||From begining of intubation to verification. Less then 5 minutes approximatly||||percentage of first pass success|||Number
2648544|NCT01684215|Secondary|Presence of Tumor Tissue Biomarker- Ki67: Phase 2|Tumor tissue biomarker, Ki67 was analyzed to investigate possible associations with resistance or sensitivity to treatment with study drugs and was selected based on its known relevance to mechanisms involved in cell cycle regulation. Number of participants with less than or equal to and greater than 20 percent of Ki67 tumor tissue biomarker were reported.|Baseline (Day 1)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||participants|||Number
2648545|NCT01684215|Secondary|Change From Baseline in Trial Outcome Index (TOI): Phase 2 at Day 1 of Cycle 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49 and End of Treatment|FACT is a modular approach to assess participant's health-related quality of life. TOI total score was derived from the sum of the 3 sub-scale scores: physical well-being, functional well-being (both sub-scales consisting of 7 items ranging from 0 to 28, where higher scores indicating better quality of life) and breast cancer subscale (consists of 9 items and ranging from 0 to 36, where higher scores indicating better quality of life). Each individual item was rated on a 5-point Likert scale, ranging from 0 (not at all good) to 4 (very well), where higher scores indicating better quality of life. TOI total score range was of 0 (not at all good) to 92 (very well), where higher scores indicating better quality of life.|Baseline (Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, End of treatment (up to 1526 days)|"Patient reported outcome (PRO) analysis set included all enrolled participants who receive at least 1 dose of study drug with both baseline and at least 1 complete post-baseline PRO assessment. Number analyzed signifies number of participants evaluable for specified time points."|||units on a scale||95% Confidence Interval|Mean
2648546|NCT01684215|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G): Phase 2 at Day 1 of Cycle 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49 and End of Treatment|FACT is a modular approach to assess participant's health-related quality of life. FACT-G total score was derived from the sum of these 4 sub-scale scores: physical well-being, social/family well-being and functional well-being (all 3 sub-scales consisting of 7 items ranging from 0 to 28, where higher scores indicating better quality of life), emotional well-being (consists of 6 items and ranging from 0 to 24, where higher scores indicating better quality of life). Each individual item was rated on a 5-point Likert scale, ranging from 0 (not at all good) to 4 (very well), where higher scores indicating better quality of life. FACT-G total score range was of 0 (not at all good) to 108 (very well), where higher scores indicating better quality of life.|Baseline (Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, End of treatment (up to 1526 days)|"Patient reported outcome (PRO) analysis set included all enrolled participants who receive at least 1 dose of study drug with both baseline and at least 1 complete post-baseline PRO assessment. Number analyzed signifies number of participants evaluable for specified time points."|||units on a scale||95% Confidence Interval|Mean
2648547|NCT01684215|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B): Phase 2 at Day 1 of Cycle 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49 and End of Treatment|The functional assessment of cancer therapy (FACT) is a modular approach to assess participant's health-related quality of life. FACT-B total score was derived from the sum of these 5 sub-scale scores: physical well-being, social/family well-being and functional well-being (all 3 sub-scales consisting of 7 items ranging from 0 to 28, where higher scores indicating better quality of life), emotional well-being (consists of 6 items and ranging from 0 to 24, where higher scores indicating better quality of life, and a breast cancer subscale (consists of 9 items and ranging from 0 to 36, where higher scores indicating better quality of life). Each individual item was rated on a 5-point Likert scale, ranging from 0 (not at all good) to 4 (very well), where higher scores indicating better quality of life. FACT-B total score range was of 0 (not at all good) to 144 (very well), where higher scores indicating better quality of life.|Baseline (Day 1 of Cycle 1), Day 1 of Cycle 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, End of treatment (up to 1526 days)|"Patient reported outcome (PRO) analysis set included all enrolled participants who receive at least 1 dose of study drug with both baseline and at least 1 complete post-baseline PRO assessment. Number analyzed signifies number of participants evaluable for specified time points."|||units on a scale||95% Confidence Interval|Mean
2648548|NCT01684215|Secondary|Overall Survival (OS): Phase 2|Overall survival was defined as the time from first dose of study treatment to date of death due to any cause. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. OS was estimated with Kaplan-Meier method.|From initiation of treatment up to follow-up period (up to 1526 days)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||months||95% Confidence Interval|Median
2648549|NCT01684215|Secondary|Percentage of Participants With Disease Control (DC): Phase 2|DC: CR, PR or stable disease (SD) for >=24 weeks according to RECIST version (v)1.1 recorded in time period between first dose of study treatment and disease progression or death to any cause. CR: disappearance of all target lesions with exception of nodal disease. All target nodes reduced to normal size (short axis <10 mm). PR: >=30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions. SD was defined as not achieving an OR with confirmed CR or PR according to RECIST v1.1, as determined by investigators, relative to response evaluable population, but remained stable for at least 24 weeks after first dose, then best overall response for such a participant was considered as stable disease. PD was defined using RECIST v1.1 as a 20% increase in sum of longest diameter of target lesions, or a measurable increase in a non-target lesion, or appearance of new lesions.|From initiation of treatment up to disease progression (up to 1526 days)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||percentage of participants|||Number
2648570|NCT01684215|Secondary|Area Under the Plasma Concentration-Time Curve From 0 to Time of Last Measurable Concentration (AUClast) of PD-0332991 Following Single Dose: Part 1 Phase 1|AUClast is area under the plasma concentration-time curve from 0 to time of last measurable concentration which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2648550|NCT01684215|Secondary|Progression Free Survival (PFS): Part 2 Phase 1|PFS was defined as the time from first dose of study treatment to the date of the first documentation of objective progression of disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|baseline up to 1673 days|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991). Data for this outcome measure was not summarized and individual participant's data was reported.|||days|||Number
2648551|NCT01684215|Secondary|Duration of Response (DOR): Phase 2|Duration of response was defined as the interval from the first documentation of objective tumor response in participants with CR (disappearance of all target lesions with the exception of nodal disease, all target nodes reduced to normal size (short axis <10 mm) or PR (a >=30 % decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to RECIST version 1.1 to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. PD was defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From initiation of treatment up to disease progression (up to 1526 days)|"Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991). Here, Overall Number of Participants Analyzed (N) signifies the participants evaluable for this outcome measure."|||months||95% Confidence Interval|Median
2648552|NCT01684215|Secondary|Duration of Response (DOR): Part 2 Phase 1|Duration of response was defined as the interval from the first documentation of objective tumor response in participants with CR (disappearance of all target lesions with the exception of nodal disease. All target nodes reduced to normal size (short axis <10 millimeter [mm]) or PR (a >=30 percent decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to RECIST version 1.1 to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first.|baseline up to 1673 days|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991). Data for this outcome measure was not summarized and individual participant's data was reported. Here, number of participants analyzed (N) signifies the participants evaluable for this outcome measure.|||days|||Number
2648553|NCT01684215|Secondary|Percentage of Participants With Objective Response: Phase 2|Objective response was defined as a complete response (CR) or partial response (PR) according to the RECIST version 1.1 recorded from first dose of study treatment until disease progression or death due to any cause. PD was defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. CR was defined as disappearance of all target lesions with the exception of nodal disease. All target nodes reduced to normal size (short axis <10 mm). PR was defined as a >=30% decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Percentage of participants with objective response (who achieved CR or PR) were reported.|From initiation of treatment up to disease progression (up to 1526 days)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||percentage of participants|||Number
2648554|NCT01684215|Secondary|Percentage of Participants With Objective Response: Phase 1|Objective response (OR) was defined as a complete response (CR) or partial response (PR) according to the RECIST version 1.1 recorded from first dose of study treatment until disease progression or death due to any cause. CR was defined as disappearance of all target lesions with the exception of nodal disease. All target nodes reduced to normal size (short axis <10 millimeter [mm]). PR was defined as a >=30 percent decrease in sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Percentage of participants with objective response (who achieved CR or PR) were reported.|From initiation of treatment up to disease progression (up to 30 months)|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||percentage of participants|||Number
2648555|NCT01684215|Secondary|Pre-dose Plasma Concentration (Ctrough) of PD-0332991: Phase 2|Ctrough is pre-dose concentration during multiple dosing which is observed directly from the actual time-concentration data.|0 (pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post dose on Cycle 1 Day 15|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2648556|NCT01684215|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PD-0332991: Phase 2|Tmax is time at which maximum plasma concentration (Cmax) was observed. It was observed directly from data as time of first occurrence.|0 (pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post dose on Cycle 1 Day 15|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||hour||Full Range|Median
2648557|NCT01684215|Secondary|Maximum Observed Plasma Concentration (Cmax) Of PD-0332991: Phase 2|Cmax is maximum plasma concentration which is observed directly from the actual time-concentration data.|0 (pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post dose on Cycle 1 Day 15|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2648558|NCT01684215|Secondary|Apparent Oral Clearance of PD-0332991: Phase 2|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing the given oral dose by AUCtau. AUCtau is the area under the plasma concentration-time curve over dosing interval which is calculated by log-linear trapezoidal method.|0 (pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post dose on Cycle 1 Day 15|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2648559|NCT01684215|Secondary|Area Under the Plasma Concentration Time Curve Over Dosing Interval (AUCtau) of PD-0332991: Phase 2|AUCtau is area under the plasma concentration-time curve over dosing interval which is calculated by log-linear trapezoidal method.|0 (pre-dose), 1, 2, 4, 6, 8, 10, 24 hours post dose on Cycle 1 Day 15|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2648560|NCT01684215|Secondary|Volume of Distribution (Vz/F) of PD-0332991 Following Single Dose: Part 1 Phase 1|Vz/F is apparent volume of distribution estimated from terminal phase, which is calculated as CL/F/kel. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing the given oral dose by area under the plasma concentration-time curve from 0 to infinity which is calculated by log-linear trapezoidal method (AUCinf). kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||liter||Geometric Coefficient of Variation|Geometric Mean
2648561|NCT01684215|Secondary|Terminal Half-Life (t1/2) of PD-0332991: Part 1 Phase 1|t1/2 is terminal elimination half-life which is calculated by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.|Single dose: 0 hour (pre-dose),1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||hour||Standard Deviation|Mean
2648562|NCT01684215|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PD-0332991: Part 1 Phase 1|Tmax is time at which maximum plasma concentration (Cmax) was observed. It was observed directly from data as time of first occurrence.|Single dose: 0 hour (pre-dose),1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||hour||Full Range|Median
2648563|NCT01684215|Secondary|Linearity (Rss) of PD-0332991 Following Multiple Dose: Part 1 Phase 1|Rss is the ratio of AUCtau (after multiple doses) to AUCinf (after single dose). AUCtau is area under the plasma concentration-time curve over dosing interval which is calculated by log-linear trapezoidal method. AUCinf is area under the plasma concentration-time curve from 0 to infinity which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ratio||Full Range|Median
2648564|NCT01684215|Secondary|Accumulation Ratio (Rac) of PD-0332991 Following Multiple Dose: Part 1 Phase 1|Rac is the ratio of AUCtau (after multiple doses) to AUCtau (after single dose). AUCtau is area under the plasma concentration-time curve over dosing interval which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ratio||Full Range|Median
2648565|NCT01684215|Secondary|Pre-dose Plasma Concentration (Ctrough) of PD-0332991 Following Multiple Dose: Part 1 Phase 1|Ctrough is pre-dose concentration during multiple dosing which is observed directly from the actual time-concentration data.|Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2648566|NCT01684215|Secondary|Cmax Dose Normalized to 125 mg of PD-0332991: Part 1 Phase 1|Cmax Dose Normalized to 125 mg is maximum plasma concentration dose normalized to 125 mg which is observed directly from the actual time-concentration data.|Single dose: 0 hour (pre-dose),1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2648567|NCT01684215|Secondary|Maximum Observed Plasma Concentration (Cmax) Of PD-0332991: Part 1 Phase 1|Cmax is maximum plasma concentration which is observed directly from the actual time-concentration data.|Single dose: 0 hour (pre-dose),1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2648568|NCT01684215|Secondary|Apparent Oral Clearance of PD-0332991: Part 1 Phase 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was calculated by dividing the given oral dose by AUCinf. AUCinf is area under the plasma concentration-time curve from 0 to infinity which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose),1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7), Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2648569|NCT01684215|Secondary|AUClast Dose Normalized to 125 mg of PD-0332991 Following Single Dose: Part 1 Phase 1|AUClast Dose Normalized to 125 mg is area under the plasma concentration-time curve from 0 to time of last measurable concentration dose normalized to 125 mg which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2648589|NCT01683994|Other Pre-specified|Number of Participants Achieving Prostatic-Specific Antigen (PSA) Decline of 30% or 50% From Baseline|PSA normal range is 4 ng/ml or lower. Participants with PSA decline of 30% or 50% is the measures for prostate cancer based on conventional reporting metrics.|up to 38 months|One participant randomized to Arm A declined to participate before treatment started.|||Participants|||Count of Participants
2648571|NCT01684215|Secondary|AUCinf Dose Normalized to 125 mg of PD-0332991 Following Single Dose: Part 1 Phase 1|AUCinf Dose Normalized to 125 mg is area under the plasma concentration-time curve from 0 to infinity dose normalized to 125 mg which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2648572|NCT01684215|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of PD-0332991 Following Single Dose: Part 1 Phase 1|AUCinf is area under the plasma concentration-time curve from 0 to infinity which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2648573|NCT01684215|Secondary|AUC24 Dose Normalized to 125 mg of PD-0332991 Following Single Dose: Part 1 Phase 1|AUC24 Dose Normalized to 125 mg is area under the plasma concentration-time curve from 0 to time 24 hours dose normalized to 125 mg which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12 and 24 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2648574|NCT01684215|Secondary|Area Under the Plasma Concentration-Time Curve From 0 to Time 24 Hours (AUC24) of PD-0332991 Following Single Dose: Part 1 Phase 1|AUC24 is area under the plasma concentration-time curve from 0 to time 24 hours which is calculated by log-linear trapezoidal method.|Single dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12 and 24 hours post-dose in Lead-in period (Day -7)|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2648575|NCT01684215|Secondary|AUCtau Dose Normalized to 125 Milligram (mg) of PD-0332991 Following Multiple Dose: Part 1 Phase 1|AUCtau Dose Normalized to 125 mg is area under the plasma concentration-time curve over dosing interval dose normalized to 125 mg which is calculated by log-linear trapezoidal method.|Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|PK parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2648576|NCT01684215|Secondary|Area Under the Plasma Concentration Time Curve Over Dosing Interval (AUCtau) of PD-0332991 Following Multiple Dose: Part 1 Phase 1|AUCtau is area under the plasma concentration-time curve over dosing interval which is calculated by log-linear trapezoidal method.|Multiple dose: 0 hour (pre-dose), 1, 2, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 8|Pharmacokinetic (PK) parameter analysis set included treated participants who had at least 1 of the PK parameters of primary interest in at least 1 PK sampling period.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2648577|NCT01684215|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities|Abnormality criteria: hemoglobin: <0.8*lower limit of normal [LLN], platelets: <0.5*LLN or >1.75*upper limit of normal [ULN], leukocytes: <0.6*LLN or >1.5*ULN, lymphocytes, total neutrophils: <0.8*LLN or >1.2*ULN, basophils, eosinophil,monocytes: >1.2*ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase (GT): >0.3*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN, total bilirubin, direct bilirubin: >1.5*ULN; blood urea nitrogen, creatinine: >1.3*ULN, uric acid: >1.2*ULN; sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, magnesium: <0.9*LLN or >1.1*ULN, phosphate: <0.8*LLN or >1.2*ULN; creatine kinase: >2.0*ULN, glucose fasting: <0.6*LLN or >1.5*ULN, glycosylated haemoglobin: >1.3*ULN;urinalysis dipstick (urine protein, urine blood >=1); urine protein 24 hour: >1.1*ULN; coagulation Activated partial thromboplastin time [APTT], Prothrombin, prothrombin international ratio: >1.1*ULN.|Part 1 Phase 1: Lead-in period (Day -7) up to 308 days; Part 2 Phase 1: Baseline (Day 1) up to 1673 days; Phase 2: Baseline (Day 1) up to 1526 days|Safety analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||Participants|||Count of Participants
2648578|NCT01684215|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) By Severity: Phase 1 (Part 1) and Phase 2|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was considered treatment emergent if occurred for the first time after the start of study treatment or occurred prior to the start of treatment but increased in NCI CTCAE version 4.0 grade during study treatment period. AE severity was defined to be the maximum toxicity grade of the TEAEs experienced by the participants during the study. AE was assessed according to severity as: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).|Part 1 Phase 1: Lead-in period (Day -7) up to 28 days after last dose of study drug (up to 308 days), Phase 2: Baseline (Day 1) up to 28 days after last dose of study drug (up to 1526 days)|Safety analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||Participants|||Count of Participants
2648579|NCT01684215|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs): Phase 1 (Part 1) and Phase 2|"A treatment related AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event had a causal relationship with the treatment or usage. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.~Relatedness was judged by investigator. AEs included both serious and non-serious adverse events."|Part 1 Phase 1: Lead-in period (Day -7) up to 28 days after last dose of study drug (up to 308 days), Phase 2: Baseline (Day 1) up to 28 days after last dose of study drug (up to 1526 days)|Safety analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||Participants|||Count of Participants
2648609|NCT01683630|Primary|Risk of Death Due to Any Cause During 30 Days Following the Index Date of Laboratory Confirmed Cases of Influenza A and B in the Province of Manitoba||Upto 15 years||||percentage of participants|||Number
2648580|NCT01684215|Primary|Percentage of Participants With 1 Year Progression Free Survival (PFS): Phase 2|PFS was defined as the time from first dose of study treatment to the date of the first documentation of objective progression of disease (PD) or death due to any cause in the absence of documented PD, whichever occurred first. PD was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.1-year PFS was defined as the percentage of participants without PFS events (PD or death due to any cause) at 12 months based on the Kaplan-Meier estimate. Percentage of participants with 1-year PFS with 90% confidence interval (CI) were reported.|From initiation of treatment up to 12 months|Full analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||percentage of participants||90% Confidence Interval|Number
2648581|NCT01684215|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) By Severity: Part 2 Phase 1|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was considered treatment emergent if occurred for the first time after the start of study treatment or occurred prior to the start of treatment but increased in National Cancer Institute (NCI) CTCAE grade during study treatment period. AE severity was defined to be the maximum toxicity grade of the TEAEs experienced by the participants during the study. AE was assessed according to severity as: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).|Baseline (Day 1) up to 28 days after last dose of study drug (up to 1673 days)|Safety analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||Participants|||Count of Participants
2648582|NCT01684215|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 2 Phase 1|"A treatment related AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event had a causal relationship with the treatment or usage. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.~Relatedness was judged by investigator. AEs included both serious and non-serious adverse events."|Baseline (Day 1) up to 28 days after last dose of study drug (up to 1673 days)|Safety analysis set included all enrolled participants who received at least 1 dose of study drug (PD-0332991).|||Participants|||Count of Participants
2648583|NCT01684215|Primary|Number of Participants With Dose Limiting Toxicities (DLT): Part 1 Phase 1|DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 as any of the events occurring during 28 days of Cycle 1,attributed to study drug:grade 4 neutropenia(for a duration of greater than [>]7 days); febrile neutropenia (grade greater than or equal to [>=]3 neutropenia,body temperature >=38.5 degree Celsius);grade >=3 thrombocytopenia with bleeding episode;grade 4 thrombocytopenia;grade >=3 non-hematologic toxicity except grade 3 or more nausea, vomiting,electrolyte abnormality(if controllable by therapy);grade 3 QTc prolongation(>500 millisecond [msec])persist after correction of reversible cause such as electrolyte abnormalities or hypoxia. Lack of hematologic recovery (platelets less than [<]50,000/microliter [mcL],absolute neutrophil count <1,000/mcL,hemoglobin <8.0 gram/deciliter [g/dL]) or prolonged non hematologic toxicities that delays initiation of next dose by >7 days;receipt of <75 percent of planned dose in first cycle due to toxicity.|Lead-in period (Day -7) up to Day 28 (Cycle 1)|DLT analysis set included all participants whom DLTs were evaluable in Part 1 Phase 1.|||Participants|||Count of Participants
2648584|NCT01684046|Primary|Subjective Lens Wear Comfort|"Lens wear comfort was assessed by the participant on a 5-point Likert scale. The participant was instructed to select a single response to the statement, When I use this solution, I can comfortably wear my lenses, with 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree."|Day 30|This analysis population includes all participants who were exposed to study regimen (test and control) and completed both study periods, excluding major protocol deviations.|||units on a scale||Standard Deviation|Mean
2648585|NCT01684033|Primary|Change From Baseline in Corneal Staining at Day 30|Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.|Baseline (Day 0), Day 30||||units on a scale||Standard Deviation|Mean
2648586|NCT01684033|Primary|Corneal Staining|Corneal staining in both eyes was assessed during slit lamp examination using flourescein dye. Each of five corneal regions (central, nasal, temporal, inferior, and superior) was graded on a scale from 0 (none) to 4 (patch). The corneal fluorescein staining score was calculated as the total of the five regions. The score ranged from 0 (no staining in any region) to 20 (patch staining in all five regions). The corneal staining of the worse eye was analyzed.|Day 30|This analysis population group includes all participants who were exposed to both treatment regimens.|||Units on a scale||Standard Deviation|Mean
2648587|NCT01684007|Secondary|Binocular Distance Corrected Visual Acuity (logMAR) - Near (40 cm)|VA was tested binocularly using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.|Day 90 from second eye implantation|This analysis population includes all subjects with both eyes implanted.|||logMAR||Standard Deviation|Mean
2648588|NCT01684007|Primary|Binocular Distance Corrected Visual Acuity (logMAR) - Intermediate (60 cm)|Visual acuity (VA) was tested binocularly (both eyes together) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 60 centimeters (cm) on the nearpoint rod. VA was measured in logarithm minimum angle of resolution (logMAR) increments, with 0.1 logMAR corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value denotes better visual acuity.|Day 90 from second eye implantation|This analysis population includes all subjects with both eyes implanted.|||logMAR||Standard Deviation|Mean
2648610|NCT01683630|Primary|Percentage of Participants With a Risk of Hospitalization Due to Any Diagnosis Within 30 Days Following the Index Date of Confirmed Cases of Influenza A and B in the Province of Manitoba||upto 15 years||||Percentage of participants|||Number
2648590|NCT01683994|Other Pre-specified|Number of Participants With a Dose Limiting Toxicities (DLTs)|A DLT are defined as adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) occurring during the first two cycles of therapy and related to the study medications (attributions: possible, probable, and definite) while fulfilling one of the following criteria: Any Grade 3 or greater non-hematologic toxicity except asymptomatic grade 3 hypertension, hypomagnesemia, hyponatremia, hypophosphatemia, hypocalcemia, and asymptomatic grade 4 uric acid. A treatment delay of > 2 weeks due to an adverse event (delays due to dental procedures are not included). Grade 4 neutropenia (absolute neutrophil count <500/µL lasting > 5 days. Febrile neutropenia. Grade 3 thrombocytopenia lasting for 7 days or more or thrombocytopenia < 50K/µL requiring platelet transfusion for bleeding.|First two cycles of treatment (each cycle is 21 days), approximately 42 days.|DLT only pertains to DL1, 2 and 3. Arms A and B did not evaluate for DLT.|||Participants|||Count of Participants
2648591|NCT01683994|Secondary|Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Adverse events were assessed from the date treatment consent signed to date off study, approximately 45 months and 14 days for Arm A; 43 months and 14 days for Arm B; 9 months and 11 days for DL1; 27 months and 1 day for DL2; & 11 months & 25 days for DL3|One participant in Arm A declined to participate before treatment started.|||Participants|||Count of Participants
2648592|NCT01683994|Primary|Maximum Tolerated Dose (MTD)|MTD is defined as the dose level at which no more than 1 of 6 patients experiences a dose limiting toxicity (DLT) at the level below that which had two instances of DLT. A DLT are defined as adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) occurring during the first two cycles of therapy and related to the study medications (attributions: possible, probable, and definite) while fulfilling one of the following criteria: Any Grade 3 or greater non-hematologic toxicity except asymptomatic grade 3 hypertension, hypomagnesemia, hyponatremia, hypophosphatemia, hypocalcemia, and asymptomatic grade 4 uric acid. A treatment delay of > 2 weeks due to an adverse event (delays due to dental procedures are not included). Grade 4 neutropenia (absolute neutrophil count <500/µL lasting > 5 days. Febrile neutropenia. Grade 3 thrombocytopenia lasting for 7 days or more or thrombocytopenia < 50K/µL requiring platelet transfusion for bleeding.|First two cycles of treatment (each cycle is 21 days), approximately 42 days.|Maximum tolerated dose was assessed only on phase 1 cohort participants. All 19 patients (e.g. 4 participants on dose level 1, 8 participants on dose level 2, and 7 participants on dose level 3) were included in the safety assessment to determine maximum tolerated dose.|||mg|||Number
2648593|NCT01683994|Primary|Progression Free Survival (PFS) of Cabozantinib + Docetaxel + Prednisone Compared to Docetaxel + Prednisone Alone|PFS is the time interval from start of treatment to documented evidence of disease progression or death. Disease progression was assessed by the Response Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions as referenced by the smallest sum on study. Appearance of one or more new lesions on bone scan and/or two consecutive rising prostatic-specific antigen values above the baseline at a minimum of one week intervals. A normal PSA value is 4.0 ng/ml and lower.|From start date of treatment until the date of first documented progression, date of death from any cause and up to 40 months, whichever occurred first.|Four participants came off study before restaging. One participant did not start treatment. Forty participants are evaluable for PFS. No participants received carbozantinib after progression from Docetaxel and Prednisone alone.|||months||Full Range|Median
2648594|NCT01683864|Other Pre-specified|Kinetics of Mitomycin and Cisplatin||24 hours after application|||||||
2648595|NCT01683864|Other Pre-specified|Procedure Related Complication|No study results because no patient has received study drug.|60 days|||||||
2648596|NCT01683864|Primary|Disease Free Survival|No study results because no patient has received study drug.|5 years|||||||
2648597|NCT01683864|Primary|Peritoneal Carcinosis Free Survival|Three patients were enrolled in the study. No study results because no patient has received study drug.|5 Years|No study results because no patient has received study drug. Patient in the intervention group withdrawal of consent before intervention.||||||
2648598|NCT01683838|Secondary|Adjusted Mean Change in Subject Bowel Function Diary Scores|"Bowel questions pertaining to the average number of minutes per day spent on bowel routine were asked of all patients daily.~A negative change in patient bowel function diary score signifies improvement."|Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.|||minutes||Standard Error|Mean
2648599|NCT01683838|Secondary|Adjusted Mean Change in Subject Bladder/Bowel Function Diary Scores|"Bowel/bladder questions pertaining to the average number of times per day the patient experienced accidental urination/leakage and the average number of bowel movements per day were asked of all patients daily.~A negative change in patient bladder/bowel function diary score signifies improvement."|Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.|||episodes||Standard Error|Mean
2648600|NCT01683838|Secondary|Change From Baseline in Mean Female Sexual Function Index (FSFI) Scores|"The FSFI is a brief, reliable, and valid self-administered questionnaire of 19 questions (items). It contains six domains: Desire (2 items score range: 1 Very low or none at all to 5 Very high), Arousal (4 items score range: 0 No sexual activity to 5 Almost always or always), Lubrication (4 items score range: 0 No sexual activity to 5 Almost always or always), Orgasm (3 items score range: 0 No sexual activity to 5 Almost always or always), Satisfaction (3 items score range: 0 No sexual activity to 5 Very satisfied) and Pain (3 items score range: 0 Did not attempt intercourse to 5 Almost never or never).~A positive change signifies improvement."|Baseline (visit 1) average score obtained at day 1 and stable treatment period (visits 4-7) average score days 28-98||||units on a scale||Standard Error|Mean
2648601|NCT01683838|Secondary|Change From Baseline in Mean International Index of Erectile Function (IIEF) Score|"Male patients were asked to complete the IIEF questionnaire on sexual function. The IIEF is a brief, reliable, and valid self-administered questionnaire of 15 questions (items) that were categorized into five domains: Erectile Function (EF) scores: 0-6 Severe dysfunction, 7-12 Moderate dysfunction, 13-18 Mild to moderate dysfunction, 19-24 Mild dysfunction, 25-30 No dysfunction. Orgasmic Function (OF) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Sexual Desire (SD) score range: 0-2 Severe dysfunction to 9-10 No dysfunction, Intercourse Satisfaction (IS) score range: 0-3 Severe dysfunction to 13-15 No dysfunction, and Overall Satisfaction (OS) score range: 0-2 Severe dysfunction to 9-10 No dysfunction.~Domain scores were derived by summing the individual items within a given domain. Final scale ranges from 0 (negative) to 5 (positive). A positive change in IIEF domain scores signifies improvement."|Baseline (visit 1) average score obtained at day 1 and stable treatment period (visit 7) average score day 98|ITT Population. N = number of participants analyzed with available data at both baseline and stable treatment period.|||units on a scale||Standard Error|Mean
2648602|NCT01683838|Secondary|Stable-dose Change From Baseline in Mean American Spinal Injury Association(ASIA) Total Motor Score|Ten key muscle groups for the right and left sides were rated on a 0 (absent) to 5 (normal) scale, with a possible total score of 100. Higher positive change scores indicate improved motor function.|Baseline (visits 2,3) average score days 7,14 and stable-dose treatment period (visits 5-7) average score days 56-98|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and stable-blind treatment period.|||units on a scale||Standard Error|Mean
2648603|NCT01683838|Secondary|Double-blind Change From Baseline in Mean Clinician's Global Impression (CGI) Scores|The supervising clinician rated the patient's neurological condition following treatment as compared to the screening visit on a seven-point scale (from 1=very much improved to 7=very much worse). The assessment was based on the clinician's overall impression of the patient's neurological status (specifically bowel, bladder, and sexual function; spasticity; and other neurological functions) and general state of health related to his or her participation in the study. Negative change scores indicated a change for the better.|Baseline (visits 2,3) average of days 7-14 and double-blind treatment period (visits 4-7) average of days 28-98)|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.|||units on a scale||Standard Error|Mean
2648604|NCT01683838|Secondary|Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores|"The Spasm Frequency score is the average rating by the clinician of the left and right arm(s) and leg(s), each evaluated on a 4-point scale (from 0=no spasms to 4=spontaneous spasms occurring more than ten times per hour), with higher scores denoting a greater degree of muscle spasms.~The Spasm Severity score is the average rating of the left and right arm(s) and leg(s), each evaluated on a three-point scale (mild, moderate, or severe) as rated by the clinician on the basis of patient self-report.~On both, a negative change in score signifies improvement in muscle spasms. The average Spasm Frequency/Spasm Severity Score was calculated as the average of the left and right non-missing scores."|Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98|ITT Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.|||units on a scale||Standard Error|Mean
2648605|NCT01683838|Primary|Double-blind Change From Baseline in Mean Subject's Global Impression (SGI) Scores|"The SGI is a 7-unit ordinal scale used by the subject to evaluate the effects of study medication on his/her quality of life during the preceding week, with higher scores denoting greater satisfaction. A positive change score in SGI signifies improved outcome.~The questionnaire consisted of one question (How do you feel about the effects of the investigational drug over the past 7 days?). The answer was based on a numerical rating scale where 1=terrible; 2=unhappy; 3=mostly dissatisfied; 4=neutral/mixed; 5=mostly satisfied; 6=pleased; 7=delighted."|Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98|ITT population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.|||units on a scale||Standard Error|Mean
2648606|NCT01683838|Primary|Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity|"The Ashworth evaluates the functioning of two lower extremity muscle groups, the hamstring and quadriceps muscles, while in the supine position. The test measures extension of the right and left hamstring muscle and flexion of the right and left quadriceps muscle using the following 5-point grading scale:~1=no increased tone; 2=slight increase in tone, giving a catch when the affected part is moved in flexion or extension; 3=more marked increase in tone, but affected part is easily flexed; 4=considerable increase in tone, passive movement is difficult; 5=affected part is rigid in flexion and extension.~The Ashworth Score was determined by adding all individual scores for each muscle group and dividing by four. Higher Ashworth Scores indicated greater spasticity."|Baseline (visits 2,3) average score days 7,14 and double-blind treatment period (visits 4-7) average score days 28-98|Intent to Treat (ITT) Population. Number of participants analyzed is number of patients with available data at both baseline and double-blind treatment period.|||units on a scale||Standard Error|Mean
2648607|NCT01683812|Secondary|Cranial Measurement Description|To describe infant head shape, the study will use cranial measurements and laser head scans in a sample of prematurely born Neonatal Intensive Care (NICU) or Special Care Nursery (SCN) patients with dolichocephaly. Cranial measurement used is cranial index, an objective measure that quantifies head shape by dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Measurements and scans will be taken directly following study enrollment and discharge to document head shape pre and post intervention. The discharge measure will be obtained at approximately 2 weeks-4 months of age at hospital discharge.|Using head measurements obtained at timepoint 1 enrollment (baseline, day 1) and at timepoint 2 discharge (14-120 days)||||cranial index %||Full Range|Median
2648608|NCT01683812|Primary|Feasibility and Safety|Nurses will complete daily logs indicating the number of desaturation events (oxygen saturation of < 90 percent for infant corrected to full term or < 87 percent for a premature infant for > 10 seconds) and emesis events (regurgitation of breast milk or formula) during cranial cup device use. The cup's designated use is for at least 12 hours per day. Study duration is at least 14 days and can continue until the infant is discharged. Comparisons will be made for the number of desaturation events and emesis during data analysis.|Logs of cranial cup use and desaturation and emesis events will be recorded for 14 -120 days||||count||Full Range|Median
2648612|NCT01683604|Secondary|Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6|The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 = no stiffness and 100 = maximum stiffness.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.|||mm||Standard Deviation|Mean
2648613|NCT01683604|Secondary|Change From Baseline in Patient's Assessment of Pain at Months 3 and 6|Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n = participants with available data for the specified visit.|||mm||Standard Deviation|Mean
2648614|NCT01683604|Secondary|Change From Baseline in VAS-Fatigue at Months 3 and 6|Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no fatigue to 100 = extreme fatigue.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.|||mm||Standard Deviation|Mean
2648615|NCT01683604|Secondary|Change From Baseline in HAQ-DI Score at Months 3 and 6|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the sum of each question, which ranges from 0 to 60, where higher scores represent higher disease activity. The change from baseline in HAQ-DI score at Month 3 and Month 6 was calculated as the difference between HAQ-D1 score reported at baseline and the HAQ-D1 score reported at Month 3 and Month 6.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n = participants with available HAQ-DI score at specified visit.|||units on a scale||Standard Deviation|Mean
2648616|NCT01683604|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6|The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0= managing very well and 100 = managing very poorly.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.|||mm||Standard Deviation|Mean
2648617|NCT01683604|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6|The physician global assessment of disease activity was evaluated using a 100 mm VAS where 0 = no arthritis activity and 100 = extremely active arthritis. Higher scores indicated increased level of disease.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.|||mm||Standard Deviation|Mean
2648618|NCT01683604|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment|ACR 20,50 or 70 response=an improvement of ≥ 20%, ≥ 50% or ≥ 70% respectively, as compared to baseline in TJC28 and SJC28, and 20%, 50% or 70% improvement in at least 3 of the 5 following measures: Patient's Assessment of Pain over the previous 24 hours, PGA, PhGA, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on the joint assessment form at baseline, no tenderness = 0 and tenderness = 1, no swelling = 0 and swelling =1, respectively. HAQ measures functional status (disability) and health-related quality of life with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0=without difficulty to 3=unable to do. Patient's assessment of pain assessed using a VAS; 0=no pain, 100=unbearable pain; PGA and PhGA, assessed using VAS ; 0= no disease activity, 100=maximum disease activity.|Month 3 and Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data for the specified visit.|||percentage of participants||95% Confidence Interval|Number
2648619|NCT01683604|Secondary|Simplified Disease Activity Index (SDAI) Score by Visit|The SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of c-reactive protein; with a total SDAI score ranged from 0-86. Higher scores indicate greater disease activity. SDAI scores of less than or equal to 3.3 represents clinical remission, less than or equal to 11.0 represents low disease activity, less than or equal to 26.0 represents moderate disease activity, and greater than 26.0 represents high (or severe) disease.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with SDAI score available at the specified visit.|||units on a scale||Standard Deviation|Mean
2648620|NCT01683604|Secondary|Change From Baseline in TJC and SJC at Month 3 and Month 6|TJC was determined by examining 28 and 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examination of 28 and 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.|||joint counts||Standard Deviation|Mean
2648870|NCT01681836|Primary|Peak Plasma Nitrite Concentration Over 24 Hour Study Period|"Post-doses refers to that subjects will receive a single dose of each study drug, oral 15Nitrogen(15N)-labeled sodium nitrate and nitrite, in random order, separated by a 3-7 day washout period"|measured at 0 (baseline), 0.5, 1, 2, 3, 6 and 24 hours post-doses||||microM||Standard Error|Mean
2648621|NCT01683604|Secondary|Clinical Disease Activity Index (CDAI) Score by Visit|The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis; with a total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of less than or equal to 2.8 represents clinical remission, score of less than or equal to 10.0 represents low disease activity, score of less than or equal to 22.0 represents moderate disease activity, and score of greater than 22.0 represents high (or severe) disease.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with CDAI score available at specified visit.|||units on a scale||Standard Deviation|Mean
2648622|NCT01683604|Secondary|Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6|Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores represent higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. Good responders experienced a change from baseline of greater than 1.2 with a DAS28 score less than or equal to 3.2.|Month 3 and Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with EULAR response available at specified visit.|||percentage of participants|||Number
2648623|NCT01683604|Secondary|Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit|The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.70 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. A score of less than 2.6 represents clinical remission, a score of greater than or equal to 2.6 and less than or equal to 3.2 represents low disease activity, a score of greater than 3.2 and less than or equal to 5.1 represents moderate disease activity, and a score of greater than 5.1 represents high (or severe) disease.|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = Participants evaluable for the outcome measure and n= participants with DAS28 score available at the specified visit.|||units on a scale||Standard Deviation|Mean
2648624|NCT01683604|Secondary|Percentage of Participants Adhering to Local Label for Adverse Events|Percentage of participants who adhered to local label/protocol for the management of adverse events is reported.|Baseline up to Month 6|FAS population. Number of participants analyzed = participants with available data for this outcome measure.|||percentage of participants|||Number
2648625|NCT01683604|Secondary|Percentage of Participants With and Without Morning Stiffness|"Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria:~Presence of participant's joints stiff when woke up that day, measured as yes or no~Duration of morning stiffness, measured using a ruler on a 100 mm VAS by 1 of the six categories: < 30 minutes, between 30 and 240 minutes, > 240 minutes, and the whole day.~Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 = no stiffness to 100 = maximum stiffness."|Baseline, Month 3, Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.|||percentage of participants|||Number
2648626|NCT01683604|Secondary|Percentage of Participants by Duration of Morning Stiffness|Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS by 1 of the six categories: less than (<) 30 minutes, between 30 and 240 minutes, greater than (>) 240 minutes and whole day.|Baseline, Month 3, Month 6|FAS population. Here, n= participants with available data at specified visit.|||percentage of participants|||Number
2648627|NCT01683604|Secondary|Duration of Tocilizumab Treatment||Baseline up to Month 6|FAS population.|||days||Standard Deviation|Mean
2648628|NCT01683604|Secondary|Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6||Baseline, Month 6|FAS population. n= participants with available data at the specified visit.|||percentage of participants|||Number
2648629|NCT01683604|Secondary|Percentage of Participants by Reason for Choice of Monotherapy at Baseline||Baseline up to Month 6|Analysis was not performed as the data was not collected on case report form.||||||
2648630|NCT01683604|Secondary|Time to Restoration of Initial Dosing Regimen||Baseline up to Month 6|Analysis was not performed due to inadequate data available for this outcome measure.||||||
2648631|NCT01683604|Secondary|Percentage of Participants With Reasons Who Discontinued Tocilizumab||Baseline up to Month 6|FAS population. Here, Number of Participants Analyzed (N) signifies participants who discontinued tocilizumab treatment.|||percentage of participants|||Number
2648632|NCT01683604|Secondary|Mean Dosing Interval at Month 6|The time interval between two successive doses in days was reported.|Month 6|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.|||days||Standard Deviation|Mean
2648633|NCT01683604|Secondary|Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change|Percentage of participants with increase or decrease in tocilizumab administration according to the reason for dose modification was reported.|Baseline up to Month 6|FAS population.|||percentage of participants|||Number
2648637|NCT01683604|Primary|Erythrocyte Sedimentation Rate (ESR) at Baseline|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.|||mm/hr||Standard Deviation|Mean
2648638|NCT01683604|Primary|Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline|TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data for the specified category.|||joint counts||Standard Deviation|Mean
2648639|NCT01683604|Primary|Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI is the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.|||units on a scale||Standard Deviation|Mean
2648640|NCT01683604|Primary|Physician Global Assessment of Disease Activity Using VAS at Baseline|Physician global assessment of disease activity was assessed on a 100 mm VAS, where 0 = no arthritis activity to 100 = extremely active arthritis.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.|||mm||Standard Deviation|Mean
2648641|NCT01683604|Primary|Patient Global Assessment of Disease Activity Using VAS at Baseline|The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0 = managing very well to 100 = managing very poorly.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.|||mm||Standard Deviation|Mean
2648642|NCT01683604|Primary|Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline|Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.|Baseline|FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.|||millimeters (mm)||Standard Deviation|Mean
2648643|NCT01683604|Primary|Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation|Percentage of participants on tocilizumab treatment at Month 6 was calculated as: [(participants on tocilizumab treatment at Month 6) divided by (participants evaluable for primary objective)] multiplied by 100.|Month 6|FAS population|||percentage of participants|||Number
2648644|NCT01683565|Other Pre-specified|Feasibility: Future Full-scale Multi-site Study|Feasibility of a future full-scale multi-site study is assessed by examining the number of children screened, the proportion of these children who screen positive for ASD, the number of children who agree to participate in the trial, the number of children who return for the second and third study visits, baseline differences in individual fatty acids between the intervention and comparison groups, and adherence to the assigned treatment.|Pre-baseline to 90 days post randomization||||Participants|||Count of Participants
2648645|NCT01683565|Secondary|Fatty Acid|The secondary outcome measures in this trial involve an examination of change in fatty acids from the first study visit to the final study visit.|Baseline to 90 days post randomization|"Rows titles are fatty acids with different C:D ratio where, C stands for Carbohydrate; D stands for Double bond; C:D is the ratio of the total amount of Carbon atoms of the fatty acid in relation to the number of double (unsaturated) bonds in it."|||nmol/mL||Standard Deviation|Mean
2648646|NCT01683565|Primary|Child Behavior-Brief Infant-Toddler Social and Emotional Assessment (BITSEA)|Brief Infant-Toddler Social and Emotional Assessment (BITSEA) is a 42 item tool that is useful for identifying social-emotional problems and/or deficits in children. BITSEA includes the following subscales: Competence (11 Items, min score:0, max score:22), problem behaviors--dysregulation (8 items, min score:0, max score:16) , externalizing (6 items, min score:0, max score:12), internalizing (8 items, min score:0, max score:16), Autism Spectrum Disorder (17 Items, min score:0, max score:34), and Red Flags (14 items, min score:0, max score:28).The questions overlap and the problem subscale is a combination of dysregulation, externalizing, and internalizing. Higher problem scores indicate greater levels of social-emotional/behavioral problems. Lower Competence scores indicate possible delay/deficit. Scores were measured at baseline and then again at study completion (90 days post randomization). The change in BITSEA scores were calculated as the value at 90 days - the value at baseline.|Baseline to 90 days post randomization||||score on a scale||Standard Deviation|Mean
2648647|NCT01683565|Primary|Child Behavior - Pervasive Developmental Disorders Screening Test-II Stage 2|The Pervasive Developmental Disorders Screening Test-II stage 2 (PDDST-II) is a 14-item measure designed to discriminate Autism Spectrum Disorders from a related non-autistic developmental disorder in children ages 12 to 48 months old. The min score is 0 and the max score is 14. Scores equal to or greater than five yield a positive screen for autism. PDDST-II scores were measured at baseline and then again at study completion (90 days post randomization). The scores were calculated as the PDDST-II value at 90 days minus the PDDST-II value at baseline.|Baseline to 90 days post randomization||||score on a scale||Standard Deviation|Mean
2648648|NCT01683526|Secondary|Complications of Intubation|Complications of intubation including aspiration, vomiting, esophageal intubation,and dental injury.|For 10 minutes post intubation||||percentage of other complications|||Number
2648649|NCT01683526|Secondary|Cardiac Arrest||For 1 hour post intubation||||percentage of cardiac arrest|||Number
2648650|NCT01683526|Secondary|Hypotension|SBP<70|For 10 minutes post intubation||||percentage of hypotension|||Number
2648651|NCT01683526|Secondary|Severe Desaturation|sat <80%|For 10 minutes post intubation||||percentage of patients with desaturation|||Number
2648653|NCT01683409|Secondary|Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady State (AUC,ss)|Evaluable pharmacokinetic concentrations from the 2-week, 4-week, 8-week, 12-week, 16-week, 20-week and 24-week time points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.|Weeks 2 and 4 (1-2 hours postdose), 8 (3-6 hours postdose), 12 (in fasted state), 16 and 20 (6-9 hours postdose), 24 (in fasted state)|All randomized participants who received at least one dose of study drug and had evaluable PK data.|||nanomole*hour (nM*hr)||Standard Deviation|Mean
2648654|NCT01683409|Secondary|Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) at Week 24|EQ-5D-5L is a 2-part measurement. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second part is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. The LS means are analyzed using an analysis of covariance (ANCOVA) model with treatment, baseline eGFR group, and baseline VAS score or baseline health state index score as covariates.|Baseline, Week 24|All randomized participants who received at least one dose of study drug. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Error|Least Squares Mean
2648655|NCT01683409|Secondary|Change From Baseline in Creatinine Clearance at Week 24|Creatinine clearance is the amount of creatinine cleared from kidney within 24 hours. The LS mean was from MMRM analyses which included treatment, baseline eGRF group, visit, treatment-by-visit interaction, baseline Creatinine Clearance, and baseline Creatinine Clearance-by-visit interaction.|Baseline, Week 24|All randomized participants who received at least one dose of study drug.|||milliliter/minute (mL/min)||Standard Error|Least Squares Mean
2648656|NCT01683409|Secondary|Change From Baseline in Urinary Monocyte Chemotactic Protein 1 (MCP-1)/Creatinine Ratio||Baseline, Week 24|Zero participants analyzed. No data analyzed due to urinary MCP-1 and creatinine being measured on different urine samples from different time points and thus not able to correlate.||||||
2648657|NCT01683409|Primary|Change From Baseline in Urinary Albumin/Creatinine Ratio (UACR) at Week 24|UACR is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine. The least squares mean (LS mean) are from mixed model repeated measures (MMRM) analyses which include treatment, baseline estimated Glomerular Filtration Rate (eGFR) group (higher: 50 to 70 mL/min/1.73m² and lower: 25 to <50 mL/min/1.73m²), visit, treatment-by-visit interaction, baseline UACR, and baseline UACR-by-visit interaction.|Baseline, Week 24|All randomized participants who received at least one dose of study drug.|||milligram/gram (mg/g)||Standard Error|Least Squares Mean
2648658|NCT01683383|Other Pre-specified|Safety Outcomes|The incidence, intervention and outcome of cardiac arrhythmia, major bleeding, altered skin integrity, pulmonary hypertension, device-related events, death, and other serious adverse events from the time of initiation of transport cooling to the time of completion will be monitored.|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total participants in each study arm|||Participants|||Number
2648659|NCT01683383|Secondary|Participants in Target Temperature Range Anytime During Transport|Participants in target temperature range (33-34 C) anytime during transport|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total participants in each study arm|||Participants|||Number
2648660|NCT01683383|Secondary|Percentage of Participants in the Target Range at 1 Hour|Percentage of participants in target range (33°-34°C) one hour after cooling initiation by the transport team|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total participants in each study arm, excluding 8 participants in the control arm and 12 participants in the device arm who completed transport in < 1 hour.|||Percentage of participants|||Number
2648661|NCT01683383|Secondary|Time to Target Temperature|Time to the target temperature range (33°-34°C) from initiation of cooling by the transport team|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total patients in each study arm|||Minutes||Standard Deviation|Mean
2648662|NCT01683383|Primary|Percentage of Temperatures in Target Range During Transport|The percentage of temperatures in the target range (33°-34°C) during transport after cooling initiation by the transport team.|Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours|Total patients in each study arm|||Percentage of temperatures||Inter-Quartile Range|Median
2648663|NCT01683331|Other Pre-specified|Incidence of Impaired Fasting Glycemia and Impaired Glucose Tolerance 6, 12 and 24 Months After Transplantation.|"Following American Diabetes Association's definition:~Impaired fasting glycemia: fasting glucose levels between 100 and 125 mg/dl;~Impaired glucose tolerance: 2 hours' OGTT values between 140 and 199 mg/dl;"|6, 12 and 24 months|||||||
2648664|NCT01683331|Secondary|The Incidence of New Onset of Diabetes After Transplant (NODAT) 24 Months After Kidney Transplantation|"NODAT will be defined according to American Diabetes Association definition:~Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or~2 hours OGTT values equal or greater than 200 mg/dl; and/or~Glycosylated hemoglobin A1c equal or greater than 6.5; and/or~On oral hypoglycemic agents and/or insulin therapy;"|24 months||||Participants|||Count of Participants
2648665|NCT01683331|Primary|The Incidence of New Onset of Diabetes After Transplant (NODAT) 12 Months After Kidney Transplantation|"NODAT will be defined according to American Diabetes Association definition:~Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or~2 hours Oral Glucose Tolerance Test (OGTT) values equal or greater than 200 mg/dl; and/or~Glycosylated hemoglobin A1c equal or greater than 6.5; and/or~On oral hypoglycemic agents and/or insulin therapy; Incidence is measured in terms of number of participants who meet any of these 4 criteria."|12 months||||Participants|||Count of Participants
2673493|NCT01461655|Secondary|Total Lesions Count|Percentage change in total lesions count from baseline to the end of treatment|Baseline to End of treatment (4 weeks)||||percentage of change||Standard Deviation|Mean
2648666|NCT01683266|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to Month 12|Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.|||percentage of participants|||Number
2648667|NCT01683266|Secondary|Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 DTSQ assessment.|||units on a scale||Standard Error|Least Squares Mean
2648668|NCT01683266|Secondary|Change in Daily Average Total Insulin Dose From Baseline to Month 6 Endpoint||Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 daily average total insulin dose assessment.|||U/kg||Standard Deviation|Mean
2648669|NCT01683266|Secondary|Change in 8--Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint|Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.|Baseline, Month 6|mITT Population. Here, n = participants with Baseline and Month 6 8­point SMPG assessment separately for each analysed time point.|||mmol/L||Standard Deviation|Mean
2648670|NCT01683266|Secondary|Percentage of Participants With FPG <7.2 mmol/L (130 mg/dL) at Month 6 Endpoint||Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment.|||percentage of participants|||Number
2648671|NCT01683266|Secondary|Percentage of Participants With Fasting Plasma Glucose (FPG) <5.6 mmol/L (100 mg/dL) At Month 6||Month 6|mITT Population.|||percentage of participants|||Number
2648672|NCT01683266|Secondary|Change in Fasting Plasma Glucose From Baseline to Month 6 Endpoint||Baseline, Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment.|||mmol/L||Standard Error|Least Squares Mean
2648673|NCT01683266|Secondary|Change in Variability of Pre-injection SMPG From Baseline to Month 6 Endpoint|Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.|Baseline, Month 6|mITT population. Number of participants analyzed = participants with baseline and Month 6 pre­injection SMPG assessment.|||percentage of mean||Standard Error|Least Squares Mean
2648674|NCT01683266|Secondary|Change In Average Pre-Injection Self-Monitored Plasma Glucose (SMPG) From Baseline Month 6 Endpoint|Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.|Baseline, Month 6|mITT population. Number of participants analyzed = participants with baseline and Month 6 pre­injection SMPG assessment.|||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
2648675|NCT01683266|Secondary|Percentage of Participants With HbA1c Less Than or Equal to 6.5% at Month 6 Endpoint||Month 6|mITT Population.|||percentage of participants|||Number
2648676|NCT01683266|Secondary|Percentage of Participants With HbA1c <7% at Month 6 Endpoint||Month 6|mITT Population.|||percentage of participants|||Number
2648677|NCT01683266|Primary|Change In HbA1c From Baseline to Month 6 Endpoint||Baseline, Month 6|Modified Intent-to-Treat (mITT) population: all randomized participants who received at least (>=)1 dose, had baseline and >=1 post­baseline assessment of any efficacy variable, irrespective of compliance. Number of participants analyzed = participants with baseline and Month 6 HbA1c assessment.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2648678|NCT01683058|Secondary|Number of Participants With Clinically Relevant Physical Examination.|The physical examination evaluation was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae.|Baseline to last visit|All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). None of the abnormalities or findings were noted during physical examination were considered clinically relevant.|||participants|||Number
2648679|NCT01683058|Secondary|Number of Participants With Clinically Relevant Laboratory Values.|The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria.|Baseline to last visit|All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). There were no clinically relevant findings with regard to laboratory values reported in this study.|||participants|||Number
2657181|NCT01607853|Secondary|Change From Baseline in Scaling at Day 22|Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 22||||units on a scale||Standard Deviation|Mean
2648680|NCT01683058|Secondary|Mean Change in Clinically Relevant Waist Circumference From Baseline in All Participants.|Clinically relevant waist circumference was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.|Baseline to last visit|Safety Sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit). Only Week 24 and last visit data was included.|||cm||Standard Deviation|Mean
2648681|NCT01683058|Secondary|Mean Change in Clinically Relevant Body Mass Index From Baseline in All Participants.|Clinically relevant body mass index was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.|Baseline to last visit|Safety Sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||Kg/m2||Standard Deviation|Mean
2648682|NCT01683058|Secondary|Mean Change in Clinically Relevant Body Weight Changes From Baseline in All Participants.|Clinically relevant body weight changes was one of the primary parameters to measure the safety and tolerability of individual participants. Each participant's body mass index (BMI) kilogram per square meter (kg/m2) were calculated from the screening. Body weight, BMI, and waist circumference changes were evaluated by calculating mean change from Baseline and by tabulating the incidence of ≥7% weight gain or loss.|Baseline to last visit|Safety Sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||Kg||Standard Deviation|Mean
2648683|NCT01683058|Secondary|Mean Change in QTcN Interval From Baseline in All Participants.|The measurement QTcN interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||msec||Standard Deviation|Mean
2648684|NCT01683058|Secondary|Mean Change in QTcF Interval From Baseline in All Participants.|The measurement QTcF interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||msec||Standard Deviation|Mean
2648685|NCT01683058|Secondary|Mean Change in QTcB Interval From Baseline in All Participants.|The measurement QTcB interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||msec||Standard Deviation|Mean
2648686|NCT01683058|Secondary|Mean Change in QT Interval From Baseline in All Participants.|The measurement QT interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||msec||Standard Deviation|Mean
2648687|NCT01683058|Secondary|Mean Change in QRS Interval From Baseline in All Participants.|The measurement QRS interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||msec||Standard Deviation|Mean
2648688|NCT01683058|Secondary|Mean Change in RR Interval From Baseline in All Participants.|The measurement RR interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||msec||Standard Deviation|Mean
2648711|NCT01682876|Secondary|Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination|Safety was assessed as the number of 2 to 5 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM|From Days 1-7 after each vaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.|||subjects|||Number
2648689|NCT01683058|Secondary|Mean Change in PR Interval From Baseline in All Participants.|The measurement PR interval is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||msec||Standard Deviation|Mean
2648690|NCT01683058|Secondary|Mean Change in Ventricular Rate From Baseline in All Participants.|The measurement ventricular rate is an ECG parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, RR, QRS, QT, QTcB, QTcN and QTcF that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||Beats/min||Standard Deviation|Mean
2648691|NCT01683058|Secondary|Mean Change in Diastolic BP From Baseline in All Participants.|The diastolic sitting BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||mmHg||Standard Deviation|Mean
2648692|NCT01683058|Secondary|Mean Change in Systolic BP From Baseline in All Participants.|The systolic sitting BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||mmHg||Standard Deviation|Mean
2648693|NCT01683058|Secondary|Mean Change in Heart Rate From Baseline in All Participants.|The heart rate sitting, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant was supine for at least 5 minutes and again after the participant was sitting for approximately 2 minutes.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||beats/min||Standard Deviation|Mean
2648694|NCT01683058|Secondary|Mean Change in Diastolic Supine BP From Baseline in All Participants.|The diastolic supine BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure and respiratory rate that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||mmHg||Standard Deviation|Mean
2648695|NCT01683058|Secondary|Mean Change in Systolic Supine Blood Pressure (BP) From Baseline in All Participants.|The systolic supine BP, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||mmHg||Standard Deviation|Mean
2648696|NCT01683058|Secondary|Mean Change in Heart Rate Supine From Baseline in All Participants.|The heart rate supine, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||beats/min||Standard Deviation|Mean
2648697|NCT01683058|Secondary|Mean Change in Body Temperature From Baseline in All Participants.|The body temperature, which is a vital sign parameter were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of treatment-emergent adverse events of potential clinical relevance included abnormal values in body temperature, heart rate, systolic and diastolic blood pressure, and respiratory rate that were identified based on pre-defined criteria.|Baseline to last visit|Safety sample was analyzed. All enrolled participants who took at least one injection of study medication in the IM depot treatment period. Last visit was defined as the last assessment visit in the treatment phase (scheduled or unscheduled visit).|||°C||Standard Deviation|Mean
2648698|NCT01683058|Secondary|Mean Change From Baseline by Week by EPS Evaluated Using Barnes Akathisia Rating Scale (BARS)|The BARS global score (range 0-5) was derived from the global clinical assessment of akathisia from the BARS panel were, 0= absent; 1= questionable; 2= mild akathisia; 3= moderate akathisia; 4= marked akathisia; 5= severe akathisia. Patients were observed while they were seated and then standing (for a minimum of 2 minutes in each position). Symptoms were observed in other situations (e.g., while engaged in neutral conversation, engaged in activity on the ward) was also rated.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.|||Units on a scale||Standard Deviation|Mean
2648699|NCT01683058|Secondary|Mean Change From Baseline by Week by EPS Evaluated Using the Abnormal Involuntary Movement Scale (AIMS)|EPS rating scale included the AIMS movement rating score (range 0-28) was the sum of the rating scores for facial and oral movements (i.e., item 1 - 4), extremity movements (i.e. item 5 - 6), and trunk movements (i.e. item 7). The symptoms for facial and oral movements were 1= muscles of facial expression, 2= lips and perioral area, 3= jaw and 4=tongue; extremity movements were, 5= upper (arms, wrists, hands, fingers), lower (legs, knees, ankles, toes), 7= neck, shoulders, hips). This scale consisted of 10 items, each to be rated on a 4-point scale of severity, and 2 questions to be answered by yes or no. To complete the scale, the patient was observed unobtrusively at rest (e.g., in waiting room). The chair used for this examination was hard, firm one without arms.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.|||Units on a scale||Standard Deviation|Mean
2648700|NCT01683058|Secondary|Mean Change From Baseline by Week by Extrapyramidal Symptoms (EPS) Evaluated Using the Simpson-Angus Scale (SAS)|The EPS rating scales included SAS total score (range 10-50) was the sum of the rating scores for 10 items from the SAS panel. This scale consists of a list of 10 symptoms, each to be rated on a 5-point scale of severity. For each symptom, the rating which best described the patient's condition were, 1= gait; 2= arm dropping; 3= shoulder shaking; 4= elbow rigidity; 5= wrist rigidity; 6= head rotation; 8= tremor; 9= salivation; 10= akathisia.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.|||Units on a scale||Standard Deviation|Mean
2648701|NCT01683058|Secondary|Mean Change From Baseline in Suicidal Ideation Intensity Total Score by the Columbia Suicide Severity Rating Scale (C-SSRS)|Data collected from C-SSRS were mapped into C-CASA. The Columbia Classification Algorithm of Suicide Assessment (C-CASA) method and C-SSRS(text in parentheses as said below) were mapped as; 1= completed suicide(completed suicide); 2= suicide attempt(actual attempt); 3= preparatory actions toward imminent suicidal behavior (interrupted attempt, aborted attempt and preparatory acts/behavior); 4= suicidal ideation(wish to die,active suicidal thought, active suicidal thought with method, active suicidal thought with intent,active suicidal thought with plan/intent); 5= self-injurious behavior, intent unknown; 6= not enough information: death; 7= non-suicidal self-injurious behavior(nonsuicidal self-injurious behavior); 8= other accident; psychiatric/medical; 9= not enough information/non-death. C-CASA category 5, 6, 8 and 9 are not applicable. For each item, each participant received an intensity score from 0(none) to 5(worst). Suicidal ideation intensity total score range from 0 to 25.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.|||Units on a scale||Standard Deviation|Mean
2648702|NCT01683058|Primary|Percentage of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Severe TEAEs, Discontinued Investigational Medicinal Product (IMP) Due to AEs, Serious TEAEs and Outcome of Death|A TEAE was defined as an AE that began after the first injection or was continuous from Baseline and was serious, study drug-related, or resulted in death.|Baseline to Week 24|In safety analysis, all enrolled participants took at least one injection of aripiprazole IM depot 400/300mg in the IM depot treatment period.|||Percentage of participants|||Number
2648703|NCT01683019|Primary|Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment.|"Outcome measured using the Hamilton Depression Rating Scale (HAMD-17) and calculated as percent change in severity score from baseline until the end of the 4th week of treatment.~The HAMD-17 scale ranges between 0-54, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates moderate to severe depression."|Assessed at baseline and the end of Week 4 of treatment.|52 subjects were randomized into the study. Of those, 7 dropped in the first week due to difficulties driving to the study site. An intent-to-treat analysis was performed on the remaining 45 subjects.|||% change in HAM-D score||Standard Error|Mean
2648704|NCT01682954|Primary|Body Weight|Change in body weight|7 Months||||kg||Standard Error|Mean
2648705|NCT01682954|Primary|Body Weight|Change in body weight|4 months||||kg||Standard Error|Mean
2648706|NCT01682928|Secondary|Metabolic Status|"Secondary:~- Changes in maternal hemodynamic status by mobilizing extravascular fluid"|admission, days 3, 5, 7/discharge and delivery|No analysis done as study halted for poor enrollment only 4 subjects enrolled total. Detailed Data cannot be reported due to participant privacy.||||||
2648707|NCT01682928|Primary|1. Primary: Number of Participants With Reversal of Oligohydramnios Using AFV Measures|Subjects amniotic fluid index via ultrasound on days 3, 5 and 7 of study participation.|days 3, and 7 or discharge|no formal analysis done on the 4 enrolled patients, study halted due to poor enrollment. Data cannot be reported due to participant privacy.||||||
2648708|NCT01682876|Secondary|Number of Subjects Who Reported Selected AEs After Any Vaccination|Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 422 after one or two vaccination(s) of MenACWY-CRM|Day 1 to Day 422|Analysis was done on safety set|||Subjects|||Number
2648709|NCT01682876|Secondary|Number of Subjects Who Reported Selected AEs After Any Vaccination|Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 86 after one or two vaccination(s) of MenACWY-CRM|Day 1 to Day 86|Analysis was done on Safety Set Unsolicited AEs|||Subjects|||Number
2648710|NCT01682876|Secondary|Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination|Safety was assessed as the number of 6 to 10 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM|From Days 1-7 after each vaccination|Analysis was done on the safety dataset|||Subjects|||Number
2648712|NCT01682876|Secondary|Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM|Immunogenicity was measured as hSBA GMTs and 95% CI against N. meningitidis serogroups A, C, W and Y at one year after one vaccination or two vaccinations of MenACWY-CRM.|One year after one vaccination or two vaccinations (day 422).|Analysis was done on the persistence PP dataset|||Titers||95% Confidence Interval|Geometric Mean
2648713|NCT01682876|Secondary|Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM|Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI at one year after one vaccination or two vaccinations of MenACWY-CRM.|One year after one vaccination or two vaccinations (day 422).|Analysis was done on the persistence PP dataset|||percentages of subjects||95% Confidence Interval|Number
2648714|NCT01682876|Secondary|Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM|Immunogenicity was measured as hSBA geometric mean titers (GMTs) and 95% CI against N. meningitidis serogroups A, C, W and Y, one month after one vaccination or two vaccinations of MenACWY-CRM.|One Month After Last Vaccination (day 86)|Analysis was done on the primary PP dataset|||Titer||95% Confidence Interval|Geometric Mean
2648715|NCT01682876|Secondary|Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM|Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 and associated 95% CI, at one month after one vaccination or two vaccinations of MenACWY-CRM.|One Month After Last Vaccination (day 86)|Analysis was done on the primary PP dataset.|||percentage of subjects||95% Confidence Interval|Number
2648716|NCT01682876|Primary|Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination|Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer <1:4 and for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.|One Month After Last Vaccination (day 86)|Analysis was done on the FAS dataset - All subjects in the exposed dataset who provided evaluable serum samples whose assay results were available for at least 1 serogroup on day 1 and 1 post baseline visit.|||percentage of subjects||95% Confidence Interval|Number
2648717|NCT01682876|Primary|Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination|Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart. Seroresponse is defined as: a. postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer <1:4; b. for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.|One Month After Last Vaccination ( day 86)|Analysis was done on the primary per-protocol (PP) dataset, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||percentage of subjects||95% Confidence Interval|Number
2648718|NCT01682863|Secondary|Change From Baseline in the Daily Number of Puffs of Rescue Medication Over the 52 Week Period|Participants completed an electronic diary (eDiary) twice daily at the same time in the morning and evening to record the number of puffs of rescue medication taken in the previous 12 hours.|52 weeks|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.|||Number of puffs||Standard Error|Least Squares Mean
2648719|NCT01682863|Secondary|Change From Baseline in Mean Total Daily Symptom Scores|The participant recorded symptom scores twice daily in the eDiary. The daily clinical symptoms included: cough, wheezing, shortness of breath, sputum volume, sputum color, and night time awakening. The range of scores for each assessment is 0 to 3 where 0 indications No symptom and 3 indicates a Severe symptom. The maximum daytime total score is 27 and the maximum nighttime total score is 27. The total daily symptom score is obtained by adding the scores for the morning and evening symptoms for each day. The maximum possible total daily score is 54. A negative change from baseline indicated improvement.|52 weeks|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.|||Score on a scale||Standard Error|Least Squares Mean
2648720|NCT01682863|Secondary|Percentage of Participants Experiencing Moderate or Severe COPD Exacerbation|Percentage of participants experiencing moderate or severe Chronic Obstructive Pulmonary Disease (COPD)|52 weeks|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis.|||Percentage of participants|||Number
2648721|NCT01682863|Secondary|Change From Baseline in FVC Measurement at All Post-baseline Time Points|Pulmonary function assessments were performed using centralized spirometry according to international standards.|Day1, 29, 57, 85, 141, 197, 253, 309, and 365|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.|||Liters||Standard Error|Least Squares Mean
2648761|NCT01682603|Primary|Net Change of the Incontinence Impact Questionnaire (IIQ-7)|"Efficacy:~Net change of the Incontinence Impact Questionnaire (IIQ-7) from baseline and 12 months.~The IIQ-7 is a 7-item short forms on a 4-point scale ranging from 0 Not at all to 3 Greatly.~Total IIQ-7 score ranges = 0 to 21 The total IIQ-7 score can therefore range from 0 to 21 (asymptomatic to very symptomatic).~Safety:~Systemic adverse events"|Baseline and 12 months||||units on a scale||Standard Deviation|Mean
2648722|NCT01682863|Secondary|Change From Baseline in 1 Hour Post-dose FEV1 Measurements|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|Day 1, 29, 57, 85, 141, 197, 253, 309, and 365|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.|||Liters||Standard Error|Least Squares Mean
2648723|NCT01682863|Secondary|Change From Baseline in Pre-dose Trough FEV1|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1. A mixed model for repeated measures (MMRM), used for this analysis, included terms of treatment, baseline FEV1 measurements, smoking status at baseline, baseline inhaled corticosteroid (ICS) use, region, baseline FEV1 * visit interaction, and visit, treatment * visit interaction.|Day 29, 57,, 85, 141, 197, 253, 309 and 365|The Full Analysis set (FAS) included all randomized patients who received at least one dose of study medication. Participants, who had both baseline and week 52 values, were included in the analysis. Patients were analyzed according to the treatment to which they were randomized.|||Liters||Standard Error|Least Squares Mean
2648724|NCT01682863|Secondary|Time to Premature Discontinuation of Treatment|methodTime to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve. The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment earl|56 weeks|The Safety set consisted of all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received.|||Days||95% Confidence Interval|Median
2648725|NCT01682863|Primary|Number of Patients With Adverse Events, Serious Adverse Events, and Death|The overall rate of adverse events reported from initiation through 30 days post last dose.|56 weeks|The Safety set:all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no AEs also constituted a safety assessment. Only deaths occurring on treatment + 30 days after end of treatment were included.|||Number of Patients|||Number
2648726|NCT01682837|Secondary|Central Aortic Diastolic Blood Pressure||4 weeks||||mmHg||Standard Deviation|Mean
2648727|NCT01682837|Secondary|Central Aortic Systolic Blood Pressure||4 weeks||||mmHg||Standard Deviation|Mean
2648728|NCT01682837|Secondary|Carotid to Femoral Pulse Wave Velocity||4 weeks||||m/s||Standard Deviation|Mean
2648729|NCT01682837|Secondary|24-hour Urinary Calcium||4 weeks of treatment||||mg/day||Standard Deviation|Mean
2648730|NCT01682837|Secondary|Serum C-terminal Telopeptide (CTX)||4 weeks||||ng/ml||Standard Deviation|Mean
2648731|NCT01682837|Secondary|Office Diastolic Blood Pressure||4 weeks||||mmHg||Standard Deviation|Mean
2648732|NCT01682837|Secondary|Office Systolic Blood Pressure||4 weeks||||mmHg||Standard Deviation|Mean
2648733|NCT01682837|Primary|24-hour Average Diastolic Blood Pressure|The average diastolic blood pressure over a 24 hour period.|4 weeks||||mmHg||Standard Deviation|Mean
2648734|NCT01682837|Primary|24-hour Average Systolic Blood Pressure|This is the average systolic blood pressure over a 24 hour period.|4 weeks|All participants who completed the study completed all 4 phases.|||mmHg||Standard Deviation|Mean
2648735|NCT01682759|Secondary|Percentage of Participants Achieving a Hemoglobin A1C of <7.0% at Week 54|The percentage of participants who achieved A1C values <7.0% (53 mmol/mol) in the FAS Population at Week 54.|Week 54|The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.|||Percentage of participants||95% Confidence Interval|Number
2648736|NCT01682759|Secondary|Change From Baseline in Body Weight at Week 54 Excluding Data After Gylcemic Rescue||Baseline and Week 54|The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.|||kg||95% Confidence Interval|Least Squares Mean
2648737|NCT01682759|Secondary|Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Excluding Data After Glycemic Rescue|Symptomatic episode of hypoglycemia was an episode with clinical symptoms reported by the investigator as hypoglycemia (concurrent fingerstick glucose not required).|Up to Week 54|The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Percentage of participants|||Number
2648738|NCT01682759|Secondary|Percentage of Participants Achieving a Hemoglobin A1C of <6.5% at Week 54|The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) in the FAS Population at Week 54.|Week 54|The FAS Population (with multiple imputation) consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.|||Percentage of participants||95% Confidence Interval|Number
2648739|NCT01682759|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 54|Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 54 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 54 minus FPG at baseline).|Baseline and Week 54|The FAS population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.|||mg/dL||95% Confidence Interval|Least Squares Mean
2648740|NCT01682759|Primary|Percentage of Participants Who Discontinued From the Study Due to an Adverse Event Excluding Data After Glycemic Rescue||Up to Week 54|The ASaT Population is defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Percentage of participants|||Number
2648741|NCT01682759|Primary|Percentage of Participants Who Experienced at Least One Adverse Event Excluding Data After Glycemic Rescue|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to Week 57|All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received.|||Percentage of participants|||Number
2648742|NCT01682759|Primary|Change From Baseline in Hemoglobin A1C at Week 54|Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 54 A1C minus the Week 0 A1C.|Baseline and Week 54|The Full Analysis Set (FAS) population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication.|||A1C (%)||95% Confidence Interval|Least Squares Mean
2648743|NCT01682720|Secondary|Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse|"Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment.~Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.~Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group."|Up to Posttreatment Week 24|Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.|||percentage of participants|||Number
2648744|NCT01682720|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.|Posttreatment Weeks 4 and 24|Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.|||percentage of participants|||Number
2648745|NCT01682720|Primary|Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.|Up to 24 weeks|Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2648746|NCT01682720|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.|Posttreatment Week 12|Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.|||percentage of participants|||Number
2648747|NCT01682681|Secondary|Percentage of Participants With Reduction in Seizure Frequency by 50 Percent or More|Percentage of participants for whom seizure frequency was reduced by greater than or equal to 50 percent after topiramate treatment were reported.|Week 52|FAS population included all participants who met all the eligibility criteria.|||Percentage of participants||95% Confidence Interval|Number
2648748|NCT01682681|Secondary|Percentage of Participants Without Seizure|Participants without seizure was calculated as percentage of participants who were found to be free of seizures and were observed up to Week 52.|Baseline up to Week 52|FAS population included all participants who met all the eligibility criteria.|||Percentage of participants||95% Confidence Interval|Number
2648749|NCT01682681|Secondary|Number of Participants Who Received Topiramate as First Mono-therapy, Second Mono-therapy or Add-on Therapy|Number of participants who received topiramate as first mono-therapy (initial treatment of epilepsy with a single drug), second mono-therapy (second line treatment with a single drug) or add-on therapy (as a supplement therapy to another drug) were reported.|Baseline up to Week 52|FAS population included all participants who met all the eligibility criteria.|||Participants|||Number
2648750|NCT01682681|Secondary|Number of Participants Who Received Concomitant Antiepileptic Drugs (AEDs)|Number of participants who received concomitant AEDs along with the topiramate were reported.|Baseline up to Week 52|FAS population included all participants who met all the eligibility criteria.|||Participants|||Number
2648751|NCT01682681|Primary|Percentage of Participants Retained to Topiramate Treatment|Participants with long term retention of topiramate until 52 weeks were reported|Week 52|The full analysis set (FAS) population included all participants who met all the eligibility criteria.|||Percentage of participants||95% Confidence Interval|Number
2648752|NCT01682642|Secondary|Total Follicle Stimulating Hormone (FSH) Dose|total dose of FSH needed at the end of stimulation|3 weeks||||IUs||Standard Deviation|Mean
2648753|NCT01682642|Other Pre-specified|Number of Days of Stimulation|number of days needed before follicles in the ovary are mature for oocyte retrieval|3 weeks||||days||Standard Deviation|Mean
2648754|NCT01682642|Secondary|Number of Cryopreserved Embryos|number of blastocytes that can be cryopreserved|1 week after oocyte retrieval||||number of cryopreserved embryos||Standard Deviation|Mean
2648755|NCT01682642|Secondary|Number of Pro Nuclear Cell (2PN)|number of 2PN|1 day after oocyte retrieval||||number of pro nuclear cells||Standard Deviation|Mean
2648756|NCT01682642|Secondary|Good Embryo Quality|The development of the embryo at the time of transfer on day 3. Good quality is defined by more than 7 cells and less then 20% fragmentation on day 3.|3 days after oocyte retrieval||||percentage of good quality embryos|||Number
2648757|NCT01682642|Secondary|Pregnancy Rate|The number of ongoing pregnancies obtained which still is the most important issue for the patients.|12 weeks||||percentage of ongoing pregnancies|||Number
2648758|NCT01682642|Primary|Number of Metaphase II Cells (MII)|number of MII cells retrieved|3 weeks||||MII cells||Standard Deviation|Mean
2648759|NCT01682603|Other Pre-specified|Autonomic Dysreflexia||Baseline and 12 months||||participants|||Number
2648760|NCT01682603|Primary|Net Change of the Quality of Life Index (QoL-I)|"Efficacy:~Net change of the quality of life index (QoL-I) from baseline and 12 months. The QoL-I on a 7-point scale ranging from 0 Delighted to 6 Terrible. The QoL-I ranges 0 to 6~Safety:~Systemic adverse events"|Baseline and 12 months||||units on a scale||Standard Deviation|Mean
2648762|NCT01682603|Secondary|Net Change of the Postvoid Residual Volume (PVR)|"Efficacy:~Net change of the postvoid residual volume (PVR) from baseline and 12 months~Results:~Botulinum toxin A injection have increased postvoid residual urine volume in patients treated for bladder dysfunction.~Treat only patients who are willing and able to initiate catheterization post-treatment, if required, for urinary retention.~Safety:~Systemic adverse events"|Baseline and 12 months||||mL||Standard Deviation|Mean
2648763|NCT01682603|Secondary|Net Change of the Detrusor Pressure (Pdet)|"Efficacy:~Net change of the detrusor pressure (Pdet) from baseline and 12 months~Safety:~Systemic adverse events"|Baseline and 12 months||||cmH2O||Standard Deviation|Mean
2648764|NCT01682603|Secondary|Net Change of the Void Volume|"Efficacy:~Net change of the void volume from baseline and 12 months~Safety:~Systemic adverse events"|Baseline and 12 months||||mL||Standard Deviation|Mean
2648765|NCT01682603|Secondary|Net Change of the Maximum Flow Rate (Qmax)|"Efficacy:~Net change of the maximum flow rate (Qmax) from baseline and 12 months~Safety:~Systemic adverse events"|Baseline and 12 months||||mL/s||Standard Deviation|Mean
2648766|NCT01682603|Secondary|Net Change of the Bladder Compliance|"Bladder compliance is the result of a mathematical calculation of the volume required for a unit rise of pressure measured during a cystometric filling.~Bladder compliance is calculated by dividing the volume change by the change in bladder pressure (mL/cmH2O).~Efficacy:~Net change of the bladder compliance from baseline and 12 months~Safety:~Systemic adverse events"|Baseline and 12 months||||mL/cmH2O||Standard Deviation|Mean
2648767|NCT01682603|Secondary|Net Change of the Cystometric Bladder Capacity (CBC)|"Efficacy:~Net change of the cystometric bladder capacity (CBC) from baseline and 12 months~Safety:~Systemic adverse events"|Baseline and 12 months||||mL||Standard Deviation|Mean
2648768|NCT01682603|Primary|Net Change of the Urinary Distress Inventory (UDI-6)|"Efficacy:~Net change of the UrinaryDdistress Inventory (UDI-6) from baseline and 12 months.~The UDI-6 is a 6-item short forms on a 4-point scale ranging from 0 Not at all to 3 Greatly.~The total UDI-6 score can therefore range from 0 to 18 (asymptomatic to very symptomatic).~Safety:~Systemic adverse events"|Baseline and 12 months||||units on a scale||Standard Deviation|Mean
2648769|NCT01682538|Secondary|Apparent Volume of Distribution (Vz/F)|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per protocol set (bioequivalence) was used for fasting treatments and per protocol set (food effect) used for fed treatment (all subjects with available PK data)|||L||Full Range|Median
2648770|NCT01682538|Secondary|Oral Clearance (CL/F)|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per protocol set (bioequivalence) was used for fasting treatments and per protocol set (food effect) used for fed treatment (all subjects with available PK data)|||L/h||Full Range|Median
2648771|NCT01682538|Secondary|Terminal Half-life|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per protocol set (bioequivalence) was used for fasting treatments and per protocol set (food effect) used for fed treatment (all subjects with available PK data)|||hours||Full Range|Median
2648772|NCT01682538|Secondary|Time to Reach C-Max (t-Max)|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per protocol set (bioequivalence) was used for fasting treatments and per protocol set (food effect) used for fed treatment (all subjects with available PK data)|||hours||Full Range|Median
2648773|NCT01682538|Secondary|AUC From Time Zero to Infinity|Measured for the Orfadin capsules and suspension treatments arms - both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Per-protocol set (bioequivalence) was used for fasted treatment groups and per-protocol set (food effect) for fed treatment group (all subjects with available PK data)|||h*uM||Full Range|Geometric Mean
2648774|NCT01682538|Secondary|The Maximum Serum Concentration (Cmax)|Measured for the Orfadin suspension treatment arms- both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Full analysis set was used; subjects with available PK data for at least one of the treatments.|||nM||Full Range|Geometric Mean
2648775|NCT01682538|Secondary|The Area Under the Serum Concentration Curve (AUC) During 72 Hours After Dose (AUC72h)|Measured for the Orfadin suspension treatments arms- both fasting and with food.|Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Full analysis set was used; subjects with available PK data for at least one of the treatments.|||uM*h||Full Range|Geometric Mean
2648776|NCT01682538|Primary|The Maximum Serum Concentration (Cmax) During Fasting Conditions.||Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Full analysis set was used; subjects with available PK data for at least one of the treatments.|||nM||Full Range|Geometric Mean
2648777|NCT01682538|Primary|The Area Under the Serum Concentration Curve (AUC) During 72 Hours After Dose (AUC72h) During Fasting Conditions.||Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose.|Full analysis set was used; subjects with available PK data for at least one of the treatments.|||uM*h||Full Range|Geometric Mean
2648785|NCT01682460|Other Pre-specified|Subjective Ratings of Comfort|Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0=very poor comfort, 0 = excellent comfort)|1 month after using artificial tears||||units on a scale||Standard Deviation|Mean
2648786|NCT01682460|Other Pre-specified|Subjective Ratings of Comfort|Participants completed a standardized grading scale regarding their subjective ratings of comfort (0-100, 0= very poor comfort, 100=excellent comfort)|1 week after using artificial tears||||units on a scale||Standard Deviation|Mean
2648833|NCT01681992|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity.|From Day 0 through the end of the study (Day 222)|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
2648778|NCT01682512|Secondary|PK (Part I Only): AUC0-inf, Ppk (Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity, Based on Individual Predicted Concentrations for Missing Data Derived From a Population PK Model, Determined Over Both Dosages)|PK (Part I only): AUC0-inf, ppk. Time zero was the time the first dose started. Only subjects randomized in part I of this study are included. A modeling approach was used to impute missing values as well as impute missing concentrations after the first dose with a sampling schedule identical to the first 2 weeks after the second dose. A unit dose of 1000 mg was used in calculating the imputed values. The resulting dataset thus consisted of PK evaluable and PK non-evaluable patients with both measured as well as imputed concentration values. The prediction of these concentrations was based on a mixed effect modeling approach and included significant covariates as identified during the PK model development (including age, body surface area [BSA], body mass index [BMI], weight, gender, race, and formulation).|Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.|Pharmacokinetic full analysis set (PKFS) included all randomized subjects with at least one valid PK concentration measurement. A valid PK concentration measurement is a value greater than lower limit of quantification as provided by Charles River.|||h*ug/mL||Geometric Coefficient of Variation|Geometric Mean
2648779|NCT01682512|Secondary|Percentage of Patients Meeting the ACR20 (American College of Rheumatology 20% Response Criteria) at Week 24 in Both Part-I and II|"A subject has an ACR20 response if all of the following occur:~a > 20% improvement in the swollen joint count (66 joints)~a > 20% improvement in the tender joint count (68 joints)~a > 20% improvement in at least 3 of the following assessments: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, patient's assessment of physical function, as measured by the Health Assessment Questionnaire - Disability Index, or Acute phase reactant (C-reactive protein).~The percentage of subjects meeting the ACR20 response criteria at Week 24 (part-I and II) is presented for subjects randomised to receive BI 695500, Rituxan and MabThera."|Week 24|FAS. Missing data have been imputed according to LOCF (last observation carried forward) and/or NRI (Non Responder Imputation).|||Percentage of participants|||Number
2648780|NCT01682512|Primary|PK (Part I Only): Observed Cmax (Maximum Plasma Concentration, Determined After the Second Dose)|PK (Part I only): observed Cmax (observed maximum plasma concentration, determined after the second dose). Only subjects randomized in part I of this study are included.|Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.|PKS|||microgram per milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2648781|NCT01682512|Primary|PK (Part I Only): AUC0-336 (Area Under the Plasma Concentration Versus Time Curve From Time Zero to 336 Hours)|PK (Part I only): AUC0-336 (area under the plasma concentration versus time curve from time zero to 336 hours after the first dose). Time zero was the time the first dose started. Only subjects randomized in part I of this study are included.|Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.|PKS|||h*ug/mL||Geometric Coefficient of Variation|Geometric Mean
2648782|NCT01682512|Primary|PK (Part I Only): AUC0-inf Pred (Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity, Determined Over Both Dosages)|PK (Part I only): AUC0-inf pred (area under the plasma concentration versus time curve from time zero to infinity, determined over both dosages, and extrapolated to infinity using predicted last observed quantifiable concentration). Time zero was the time the first dose started. Only subjects randomized in part I of this study are included.|Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.|PKS|||h*ug/mL||Geometric Coefficient of Variation|Geometric Mean
2648783|NCT01682512|Primary|PK (Part I Only): AUC0-tz (Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration, Determined Over Both Dosages)|"Pharmacokinetic (PK) (Part I only): AUC0-tz (area under the plasma concentration versus time curve from time zero to the last measurable concentration, determined over both dosages). Time zero was the time the first dose started. Only subjects randomized in part I of this study are included. As per protocol all the following criteria had to be fulfilled for a patient to be defined as PK evaluable for the Pharmacokinetic analysis set (PKS):~Full first and second dose given. Pre-dose concentration available prior to the second dose. Ability to estimate AUC during the infusion phases. Ability to estimate the AUC for the distribution phase after the second dose. Ability to estimate the terminal half-life (t1/2) after the second dose.~gMean - Geometric Mean"|Blood PK samples were collected at -00:05 (hours: min) prior to first infusion and 03:55, 24:00, 335:55, 338:00, 339:55, 342:00, 344:00, 360:00, 432:00, 504:00, 672:00, 1176:00, 1512:00, 2352:00 and 2688:00 after first infusion.|Pharmacokinetic analysis set (PKS) consisted of all randomized subjects who were PK evaluable based on protocol defined criteria.|||Hour(h)*Microgram(ug)/Milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
2648784|NCT01682512|Primary|Change of Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 [ESR]) From Baseline to Week 24 (BI 695500 Versus Rituxan®) - Part I|"The DAS28 score was derived using the formula: DAS28 (ESR) = 0.56*√(TJC28) + 0.28*√(SJC28) + 0.70*ln(ESR) + 0.014*(GH), where, TJC28 = 28 joint count for tenderness, SJC28 = 28 joint count for swelling, Ln(ESR) = natural logarithm of ESR, GH = the General Health component of the DAS [score on a visual analogue scale (VAS) ranging from 0 (very well) to 100 (very poor)].~DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. Low disease activity is defined as a DAS28 score of ≤ 3.2 and DAS28 remission is defined as a DAS28 score of < 2.6. A clinically important change in DAS28 score is defined as an improvement in DAS28 score of at least 1.2.~The full analysis set (FAS) contained all randomized subjects who received at least one dose of trial medication, had at least one assessment of primary efficacy endpoint at Baseline and at post-baseline visit prior or at Week 24 visit."|Baseline and Week 24|FAS. Since this endpoint was designed to establish statistical equivalence of efficacy of BI 695500 and Rituxan®, only subjects randomized to BI 695500 and Rituxan® in part-I of study are included.|||Unit on scale||90% Confidence Interval|Least Squares Mean
2657182|NCT01607853|Secondary|Change From Baseline in Scaling at Day 18|Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 18||||units on a scale||Standard Deviation|Mean
2648787|NCT01682460|Secondary|Ocular Surface Disease Index (OSDI) Score|"The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worse possible score)."|1 month after using artificial tears||||units on a scale||Standard Deviation|Mean
2648788|NCT01682460|Secondary|Ocular Surface Disease Index (OSDI) Score|"The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score)."|1 week after using artificial tears||||units on a scale||Standard Deviation|Mean
2648789|NCT01682460|Other Pre-specified|Subjective Ratings of Comfort|Participants completed a standardized grading scale regarding their subjective ratings of comfort (0 = very poor comfort, 100=excellent comfort)|At baseline (dispensing visit)||||units on a scale||Standard Deviation|Mean
2648790|NCT01682460|Secondary|Ocular Surface Disease Index (OSDI) Score|"The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 (best possible score) to 100 (worst possible score)."|At baseline (dispensing visit)||||units on a scale||Standard Deviation|Mean
2648791|NCT01682460|Primary|Tear Break up Time With Fluorescein|The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .|After 1 month||||seconds||Standard Deviation|Mean
2648792|NCT01682460|Primary|Tear Break up Time With Fluorescein|The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .|After 1 week||||seconds||Standard Deviation|Mean
2648793|NCT01682460|Primary|Tear Break up Time With Fluorescein|The time taken for the tear film to break up on the surface of the cornea will be measured using slit lamp biomicroscopy following fluorescein instillation .|At baseline (dispensing visit)||||seconds||Standard Deviation|Mean
2648794|NCT01682460|Primary|Ocular Surface Staining|Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence|After 1 month||||units on a scale||Standard Deviation|Mean
2648795|NCT01682460|Primary|Ocular Surface Staining|Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence|After 1 week||||units on a scale||Standard Deviation|Mean
2648796|NCT01682460|Primary|Ocular Surface Staining|Corneal staining assessed using slit lamp biomicroscopy on a 1-5 scale where 0=no staining and 5= >30 dots + confluence|At baseline (dispensing visit)||||units on a scale||Standard Deviation|Mean
2648797|NCT01682148|Secondary|Investigator Preference of Injection Technique|"When all patients at the site had completed the study (last subject last visit) a global assessment of the injection technique was to be made by the Investigators. The following question was answered: Based on your experience during this study, which injection technique do you prefer?"|Following last visit of the last subject at each site|The question on preferred injection technique was answered by 3 of the 20 Investigators.|||Investigators|||Number
2648798|NCT01682148|Secondary|Subject Global Evaluation of Treatment Effect|Comparison of treatment effect between previous (prestudy) and study treatment cycles assessed by the subject at the end of study (Week 12 up to Week 24 (Visit 3 or Visit 4)). Categorised as follows: Much worse / Worse / Same / Better / Much better.|Up to Week 24|ITT population: all treated subjects having at least one Baseline assessment of the primary efficacy parameter. Only subjects with non-missing values were included in the analysis. If a subject had more than one evaluation entry, the last one was used.|||Participants|||Count of Participants
2648799|NCT01682148|Secondary|Achievement of the Primary Goal Measured by Goal Attainment Scale (GAS)|At Baseline, an agreed primary goal related to elbow flexion in one of the following categories was determined: active function, impairment, involuntary movement, mobility, pain passive function or other. Each goal was usually rated -1, unless the subject was as bad as he/she could be in that particular goal area, in which case the Baseline score was -2. The evaluator rated the outcome score at Week 4 or Week 12, depending on the time point defined at the baseline visit (Visit 1), using the GAS five-point scale (-2, -1, 0, +1 and +2).|Up to Week 12|ITT population: all treated subjects having at least one Baseline assessment of the primary efficacy parameter. Only subjects with non-missing values were included in the analysis. Only overall GAS score data are summarised below.|||Participants|||Count of Participants
2648800|NCT01682148|Secondary|Injection Site Pain Measured by VAS at Day 1.|Pain assessment using the VAS. The VAS was a 100 mm straight horizontal line scoring scale. Score range on VAS was from 0 to 100 where 0 indicated no pain and 100 indicated worst pain imaginable.|Baseline|ITT population: all treated subjects having at least one Baseline assessment of the primary efficacy parameter. Only subjects with non-missing values were included in the analysis.|||mm||Standard Deviation|Mean
2648801|NCT01682148|Secondary|Change From Baseline of Spasticity Related Pain Measured by Visual Analogue Scale (VAS), Assessed by the Subject|Pain assessment using the VAS. The VAS was a 10 cm straight horizontal line scoring scale. Score range on VAS was from 0 to 10 where 0 indicated no pain and 10 indicated worst pain imaginable.|Baseline, Week 4 and Week 12|"ITT population: all treated subjects having at least one Baseline assessment of the primary efficacy parameter.~CCP=Current Clinical Practice; N'=number of subjects with data at each time point for each treatment group; NMJ=neuromuscular junction."|||Change in VAS from Baseline||Standard Deviation|Mean
2648802|NCT01682148|Secondary|Change From Baseline for Elbow Flexors Muscle Tone as Measured by the MAS at Week 12|A clinically relevant change was one level decrease on the MAS scale. Subjects meeting the defined decrease at Week 12 were considered as responders.|Baseline to Week 12|ITT population: all treated subjects having at least one Baseline assessment of the primary efficacy parameter. Only subjects with non-missing values were included in the analysis.|||responders|||Number
2648803|NCT01682148|Secondary|Change From Baseline for Elbow Flexors Muscle Tone as Measured by the Modified Ashworth Scale (MAS) at Week 4 and Week 12|Increased muscle tone in elbow flexors was assessed using the MAS. Scale ranges from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension).|Baseline to Week 12|"ITT population: all treated subjects having at least one Baseline assessment of the primary efficacy parameter. Only subjects with non-missing values were included in this analysis.~CCP=Current Clinical Practice; N'=number of subjects with data at each time point for each treatment group; NMJ=neuromuscular junction."|||units on a scale||Full Range|Median
2648804|NCT01682148|Primary|Change From Baseline for Elbow Flexors Muscle Tone as Measured by the Modified Ashworth Scale (MAS) at Week 4|A clinically relevant change was one level decrease on the MAS scale. Subjects meeting the defined decrease at Week 4 were considered as responders in the primary efficacy analysis.|Baseline to Week 4|The primary analysis was based on both the ITT and Per Protocol (PP) populations. The ITT population was all treated subjects having at least one Baseline assessment of the primary efficacy parameter. The PP population was all subjects in the ITT population for whom no major protocol violations or deviations occurred until Week 4 (Visit 2).|||responders|||Number
2648805|NCT01682135|Secondary|Number of Participants With Best Objective Response (BOR)|Participants achieved disease control if they had a BOR of CR, PR or SD. Progressive Disease (PD) and those participants which were Not Evaluable (NE) were also reported. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started.|Baseline to Progressive Disease or Participant Stopped Study (Up to 10 Weeks)|All enrolled participants who received at least one dose of study drug.|||Participants|||Number
2648806|NCT01682135|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|A sample will be considered positive for circulating anti-ramucirumab antibodies if it exhibits a post-baseline antibody level that exceeds the upper 95% confidence interval of the mean determined from the normal anti-ramucirumab level seen in healthy untreated individuals. A participant will be considered to have an anti-ramucirumab response if there are 2 consecutive positive samples or if the final sample tested is positive.|Cycle 1: Pre-infusion, Cycle 2: Pre-infusion, Cycle 3: Pre-infusion|All enrolled participants who received at least one dose of study drug and had evaluable immunogenicity data.|||Participants|||Number
2648807|NCT01682135|Secondary|Time to Disease Progression|Time to progressive disease was measured from the start of study drug until progressive disease. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis.|Baseline to Progressive Disease (Up to 10 Weeks)|All enrolled participants who received at least one dose of study drug. Censoring for Cohort 1, 2 and 3: 3, 2 and 2, respectively.|||Months||95% Confidence Interval|Median
2648808|NCT01682135|Secondary|Duration of Stable Disease (SD)|Duration of SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum of diameters while on study. SD is measured at the start of the study drug until progressive disease or death due to any cause, whichever is first. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis.|Baseline to Progressive Disease or Death Due to Any Cause (Up to 10 Weeks)|All enrolled participants who received at least one dose of study drug and had evaluable SD data. Participants censored for Cohort 1, 2, and 3: 3, 2, and 1, respectively.|||Months||95% Confidence Interval|Median
2648809|NCT01682135|Secondary|Duration of Response|Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. For each participant who is not known to have died or to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, duration of tumor response was to be censored at the date of the participant's last objective tumor assessment prior to that cut-off date.|Time Between Meeting Response Criteria and Progressive Disease or Death Due to Any Cause (Up to 10 Weeks)|All enrolled participants who received at least one dose of study drug. There were no participants censored due to no CR or PR responses.|||Months||95% Confidence Interval|Median
2648810|NCT01682135|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Ramucirumab|Cycle 1 analysis performed: Area Under the Concentration-Time Curve Zero to Infinity (AUC[0-∞]); Cycle 2 analysis performed: Area Under the Concentration-Time Curve Over the Dosing Interval at Steady State (AUC[τ,ss])|Cycle 1 & 2: Predose, End of Infusion, 0.5 hour (h) ,1h, 2h, 4h, 8h, 24h, 48h,72h or 96h, 168h, 264h, and 336h Postdose (and 504h Postdose Cohort 2 only)|All enrolled participants who received at least one dose of study drug and had evaluable AUC(0-∞) for Cycle 1 and AUC(τ,ss) for Cycle 2 PK data.|||Microgram*day/milliliter (µg*day/mL)||Geometric Coefficient of Variation|Geometric Mean
2648811|NCT01682135|Primary|Pharmacokinetics: Minimum Concentration (Cmin) of Ramucirumab||Cycle 2-5: Predose|All enrolled participants who received at least one dose of study drug and had evaluable Cmin PK data.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2648812|NCT01682135|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Ramucirumab||Cycle 1 & 2: Predose, End of Infusion, 0.5 hour (h) ,1h, 2h, 4h, 8h, 24h, 48h,72h or 96h, 168h, 264h, and 336h Postdose (and 504h Postdose Cohort 2 only)|All enrolled participants who received at least one dose of study drug and had evaluable Cmax pharmacokinetics (PK) data.|||microgram/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2648813|NCT01682135|Primary|Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)|A summary of AEs and SAEs considered by the investigator to be drug-related is located in the Reported Adverse Events module. An AE is summarized if the onset date is on or after the first dose of study drug and within 30 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.|Baseline through Study Completion (Up to 12 Weeks)|All enrolled participants who received at least one dose of study drug.|||Participants|||Number
2648814|NCT01682083|Secondary|Freedom From Relapse|Freedom from relapse (FFR) of dabrafenib and trametinib as a combination therapy versus placebo. In the FFR analysis, local or distant recurrence or a new primary melanoma were counted as events, and patients who died of causes other than melanoma or treatment-related toxicity were censored.|approximately 3.5 years|ITT population|||Participants with events|||Number
2648815|NCT01682083|Secondary|Distant Metastasis-free Survival|Distant metastasis-free survival (DMFS) of dabrafenib and trametinib as a combination therapy versus placebo. In the DMFS analysis, the first occurrence of distant metastasis or death (if it occurred before documented recurrence) was counted as an event.|approximately 3.5 years|ITT population|||Participants with events|||Number
2648816|NCT01682083|Secondary|Overall Survival|Overall survival (OS) of dabrafenib and trametinib as a combination therapy versus placebo|approximately 3.5 years|ITT population|||Participants|||Count of Participants
2648817|NCT01682083|Primary|Relapse-free Survival (RFS)|Recurrence-free survival was defined as the time from randomization to disease recurrence (local recurrence, distant recurrence, second primary melanoma), or death from any cause.|Approximately 3.5 years|Intent-to-Treat (ITT) Population|||Participants with events|||Number
2648818|NCT01682044|Secondary|Percent Change in Serum Levels of Free Radical Levels (MFI) From Baseline|Mean percent change in MFI level from baseline.|Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39|All treated and eligible patients|||percent change||Standard Deviation|Mean
2648819|NCT01682044|Secondary|Percent Change in Serum Levels of Interferon Alpha (INF) From Baseline|Mean percent change in INF level from baseline.|Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39|All treated and eligible patients|||percent change||Standard Deviation|Mean
2648820|NCT01682044|Secondary|Percent Change in Serum Levels of Tumor Necrosis Factor (TNF) From Baseline|Mean percent change in TNF level from baseline at each visit.|Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39|All treated and eligible patients|||percent change||Standard Deviation|Mean
2648821|NCT01682044|Secondary|Percent Change in CD20 Antigen Expression and Density of Expression|Percent change in CD20 antigen expression and density of expression|At 4 years|Samples tissues were not large enough to perform analysis. No participants were analyze.||||||
2648822|NCT01682044|Secondary|Percent Change in Functional and Phenotypic Characteristics of Host Neutrophils From Baseline|Mean percent change in CD11b level from baseline at each visit|Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39|All treated and eligible patients|||percent change||Standard Deviation|Mean
2648823|NCT01682044|Secondary|Overall Response Rate|Overall Response is defined as Complete Response: During observation, no disease is apparent, including measurable and non-measurable disease, and no evidence of disease is observed for at least 28 days, as confirmed by a second assessment following the original observation of no disease; and Partial Response: A 50% or greater decrease from baseline in the sum of the products of the longest perpendicular diameters of all the measured lesions is noted for at least 28 days as confirmed by a second assessment following the observation of the 50% or greater decrease, and no appearance of new lesions is noted.|Up to 43 weeks|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2648824|NCT01682044|Primary|Number of Participants With Adverse Events|Frequency of Adverse Events, Graded According to NCI CTCAE v3.0. Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE|Up to 90 days after the last dose of study drugs|All treated and eligible patients|||Participants|||Count of Participants
2648825|NCT01682031|Secondary|Plasma Cisplatin and Selenium PK and PD Markers (NZ Only)|Descriptive statistics will be used to describe the mean plasma cisplatin and selenium at each time point. Repeated measures analysis of variance will be used to evaluate the changes in plasma cisplatin and selenium over time. Analysis of pharmacodynamic markers will be conducted using statistical methods appropriate for within-patient sequential analyses, such as repeated measures analysis of variance.|Up to 3 months post-treatment|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2648826|NCT01682031|Secondary|CRT Dose Delivery|This characteristic will be included in Cox models.|Up to 8 weeks|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2648827|NCT01682031|Secondary|Incidence of Grade 3 or 4 Treatment-related Toxicities, Including Xerostomia|Will be compared as difference in proportions with 95% confidence intervals.|Up to 5 years post-treatment|All treated and eligible patients|||number of xerostomia events|||Number
2648828|NCT01682031|Secondary|Quality of Life||Up to 1 year post-treatment|Due to the study's early termination and inadequate number of patients, no patients were analyzed.||||||
2648829|NCT01682031|Secondary|Overall Survival|Estimated using the Kaplan-Meier method. Log-rank tests will be used for the comparison of survival distributions among study groups. Continuous endpoints will be summarized using means, standard deviations and percentiles.|Up to 5 years post-treatment|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2648830|NCT01682031|Secondary|Relapse-free Survival (RFS)|Assessed by Kaplan-Meier RFS curves and the proportion with an event at 1 year for RFS will be compared simultaneously to obtain more global sensitivity to differences in time-to-event.|At 1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2648831|NCT01682031|Secondary|Tumor Complete Response Rate|Will be compared as difference in proportions with 95% confidence intervals. Disease will be measured according to the Response Evaluation Criteria in Solid Tumors (RECIST).|Up to 5 years post-treatment|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2648832|NCT01682031|Primary|Incidence of >= Grade 3 Mucositis|Will be compared as difference in proportions with 95% confidence intervals.|Up to 5 years|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.||||||
2648834|NCT01681992|Secondary|Number of Subjects Reporting Any AEs of Specific Interest|AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.|From Day 0 through the end of the study (Day 222)|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
2648835|NCT01681992|Secondary|Number of Subjects Reporting Any Unsolicited AES Post Dose 2|Unsolicited AE was defined as any AE reported in reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
2648836|NCT01681992|Secondary|Number of Subjects Reporting Any Unsolicited AES Post Dose 1|Unsolicited AE was defined as any AE reported in reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
2648837|NCT01681992|Secondary|Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 2|Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
2648838|NCT01681992|Secondary|Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 1|Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
2648839|NCT01681992|Secondary|Number of Subjects Reporting Any Rash Post Dose 2|Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
2648840|NCT01681992|Secondary|Number of Subjects Reporting Any Rash Post Dose 1|Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
2648841|NCT01681992|Secondary|Number of Subjects Reporting Any Fever Post Dose 2|Any fever = Fever (axillary) ≥ 38°C.|During the 43-day (Days 0-42) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
2648842|NCT01681992|Secondary|Number of Subjects Reporting Any Fever Post Dose 1|Any fever = Fever (axillary) ≥ 38°C.|During the 43-day (Days 0-42) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
2648843|NCT01681992|Secondary|Number of Subjects With Any Solicited General AEs Post Dose 1|Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.|During the 15-day (Days 0-14) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
2648844|NCT01681992|Secondary|Number of Subjects With Any Solicited Local AEs Post Dose 2|Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.|During the 4-day (Days 0-3) post-vaccination period|TVC included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
2648845|NCT01681992|Secondary|Number of Subjects With Any Solicited Local Adverse Events (AEs) Post Dose 1|Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.|During the 4-day (Days 0-3) post-vaccination period|Total Vaccinated cohort (TVC) included all vaccinated subjects with at least one vaccine administration of either Inv_MMR lots or Com_MMR lots documented.|||Participants|||Count of Participants
2648846|NCT01681992|Secondary|Anti-rubella Virus Antibody Concentrations (by ELISA)|Antibody concentrations were expressed as GMCs in IU/mL.|At Day 84|ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- & post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample & complied with post-dose 2 blood sample schedule.|||IU/mL||95% Confidence Interval|Geometric Mean
2648847|NCT01681992|Secondary|Anti-mumps Virus Antibody Concentrations (by ELISA)|Antibody concentrations were expressed as GMCs in EU/mL.|At Day 84|ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- & post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample & complied with post-dose 2 blood sample schedule.|||EU/mL||95% Confidence Interval|Geometric Mean
2648906|NCT01681472|Secondary|T(Last) of [6R]-5,10-methylene-THF|The time-point for the last measurable concentration of the active substance in Modufolin: [6R]-5,10-methylene-THF|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||h||Standard Deviation|Mean
2648848|NCT01681992|Secondary|Anti-measles Virus Antibody Concentrations (by ELISA)|Antibody concentrations were expressed as GMCs in mIU/mL.|At Day 84|ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- & post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample & complied with post-dose 2 blood sample schedule.|||mIU/mL||95% Confidence Interval|Geometric Mean
2648849|NCT01681992|Secondary|Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)|For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration < 4 IU/mL) before dose 1.|At Day 84|ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- & post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample & complied with post-dose 2 blood sample schedule.|||Percentage of subjects||95% Confidence Interval|Number
2648850|NCT01681992|Secondary|Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)|For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration < 5 EU/mL) before dose 1.|At Day 84|ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- & post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample & complied with post-dose 2 blood sample schedule.|||Percentage of subjects||95% Confidence Interval|Number
2648851|NCT01681992|Secondary|Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)|For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥ 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration < 150 mIU/mL) before dose 1.|At Day 84|ATP cohort for analysis of immunogenicity post dose 2: all eligible subjects from US sub-cohort who received 2 doses of Inv_MMR/Com_MMR vaccine, with pre- & post-dose 2 serology results for at least 1 vaccine antigen for MMR, did not meet elimination criteria up to Day 84 blood sample & complied with post-dose 2 blood sample schedule.|||Percentage of subjects||95% Confidence Interval|Number
2648852|NCT01681992|Primary|Anti-rubella Virus Antibody Concentrations (by ELISA)|Antibody concentrations were expressed as GMCs in IU/mL.|At Day 42|ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- & post-dose 1 serology results & were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample & complied with post-dose 1 blood sample schedule.|||IU/mL||97.5% Confidence Interval|Geometric Mean
2648853|NCT01681992|Primary|Anti-mumps Virus Antibody Concentrations (by PRNT)|Antibody concentrations were expressed as Geometric Mean Titers (GMTs).|At Day 42|ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- & post-dose 1 serology results & were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample & complied with post-dose 1 blood sample schedule.|||Titers||95% Confidence Interval|Geometric Mean
2648854|NCT01681992|Primary|Anti-mumps Virus Antibody Concentrations (by ELISA)|Antibody concentrations were expressed as GMCs in EU/mL.|At Day 42|ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- & post-dose 1 serology results & were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample & complied with post-dose 1 blood sample schedule.|||EU/mL||97.5% Confidence Interval|Geometric Mean
2648855|NCT01681992|Primary|Anti-measles Virus Antibody Concentrations (by ELISA)|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.|At Day 42|ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- & post-dose 1 serology results & were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample & complied with post-dose 1 blood sample schedule.|||mIU/mL||97.5% Confidence Interval|Geometric Mean
2648856|NCT01681992|Primary|Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)|For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration < 4 IU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for rubella virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.|At Day 42|ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- & post-dose 1 serology results & were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample & complied with post-dose 1 blood sample schedule.|||Percentage of subjects||97.5% Confidence Interval|Number
2648857|NCT01681992|Primary|Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by Plaque Reduction Neutralization Test [PRNT])|For mumps virus as measured by PRNT, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 4 End point Dilution 50% (ED50) (PRNT) among subjects who were seronegative (antibody concentration < 2.5 ED50) before dose 1.|At Day 42|ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- & post-dose 1 serology results & were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample & complied with post-dose 1 blood sample schedule.|||Percentage of subjects||95% Confidence Interval|Number
2648868|NCT01681836|Secondary|Peak Percentage Level of Methemoglobin Over 24 Hour Study Period|"Post-doses refers to that subjects will receive a single dose of each study drug, oral 15N-labeled sodium nitrate and nitrite, in random order, separated by a 3-7 day washout period"|measured at 0 (baseline), 0.5, 1, 2, 3, 6 and 24 hours post-doses||||percentage level||Standard Error|Mean
2648869|NCT01681836|Primary|Peak Red Blood Cell (RBC) Iron-nitrosyl Hemoglobin (NO-Hb) Concentrations Over 24 Hour Study Period|"Post-doses refers to that subjects will receive a single dose of each study drug, oral 15Nitrogen(15N)-labeled sodium nitrate and nitrite, in random order, separated by a 3-7 day washout period"|measured at 0 (baseline), 0.5, 1, 2, 3, 6 and 24 hours post-doses||||microMolar||Standard Error|Mean
2648858|NCT01681992|Primary|Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)|For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration < 5 EU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for mumps virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.|At Day 42|ATP cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- & post-dose 1 serology results & were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample & complied with post-dose 1 blood sample schedule.|||Percentage of subjects||97.5% Confidence Interval|Number
2648859|NCT01681992|Primary|Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by Enzyme-linked Immunosorbent Assay [ELISA])|For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal or above [≥] 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration less than [<] 150 mIU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for measles virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to measles virus.|At Day 42|According-to-protocol (ATP) cohort for analysis of immunogenicity post dose 1: all eligible subjects with pre- & post-dose 1 serology results & were below assay cut-off for at least 1 vaccine antigen for MMR at pre-vaccination, did not meet elimination criteria up to Day 42 blood sample & complied with post-dose 1 blood sample schedule.|||Percentage of subjects||97.5% Confidence Interval|Number
2648860|NCT01681849|Secondary|Change in Brain Blood Flow Assessed by Statistical Parametric Mapping (SPM)|Participants were exposed to traumatic scripts versus neutral scripts before and after treatment with paroxetine or placebo. Brain blood flow was measured using statistical parametric mapping (SPM) which analyzes brain imaging data sequences. Statistical Parametric Mapping software is only capable of producing a single z-score for each Arm/Group. Data for each participant can not be generated using this software and therefore are not available to summarize in the data table below. Regional blood flow was compared for stress and neutral conditions and before and after treatment with paroxetine or placebo. Higher z-scores indicate an increase in regional blood flow to the medial prefrontal cortex under stress conditions for the 3 month time point relative to baseline. Statistical Parametric Mapping software is only capable of producing a single z-score for each Arm/Group.|Baseline, 3 Months Post Treatment|Statistical analyses yielded image data sets in which the values assigned to individual voxels correspond to the t-statistic of the difference in brain blood flow between conditions. Statistical images were displayed with values of z score units.|||z-scores|||Number
2648861|NCT01681849|Primary|Mean Clinical Administered PTSD Scale for DSM-IV (CAPS) Score|The CAPS is a 30-item questionnaire of PTSD symptomatology that provides continuous measures of symptom severity and frequency. CAPS-IV total symptom severity score is calculated by summing severity scores for the 17 DSM-IV PTSD symptoms. Each symptom is rated for severity based on frequency and intensity on a scale of 0-4 for a total possible severity score per symptom of 8. Criterion E (items 18-19) is duration of symptoms (minimum of one month to make the diagnosis). Items 20-30 are optional. CAPS score is based on items 1-17, CAPS score has a potential range of 0-136, with higher scores indicating greater severity of PTSD symptoms. CAPS was performed before and after treatment with paroxetine or placebo in PTSD patients.|Baseline, End of Study (Up to 52 Weeks)|Data for participants who completed all study visits were analyzed.|||units on a scale||Standard Deviation|Mean
2648862|NCT01681836|Secondary|Peak Change in Heart Rate Over 24 Hour Study Period|"Post-dose refers to that subjects will receive a single dose of each study drug, oral 15N-labeled sodium nitrate and nitrite, in random order, separated by a 3-7 day washout period"|measured at 0 (baseline), every 15 minutes during the first 2 hours post-dose, then at 3, 6, and 24 hours post-dose, change at 1.5 hours for nitrate and 24 hours for nitrite||||beats per minute||Standard Error|Mean
2648863|NCT01681836|Secondary|Percent Platelet Activation at 6 Hours|"at timepoint with greatest change from 0 (trough); Post-dose refers to that subjects will receive a single dose of each study drug, oral 15N-labeled sodium nitrate and nitrite, in random order, separated by a 3-7 day washout period; percentage of platelets that express 2 specific markers identifying activated platelets (CD41 and CD62-P) were quantified using flow cytometry"|measured at 0 (baseline), 6 and 24 hours post-dose||||% of platelets that are activated||Standard Error|Mean
2648864|NCT01681836|Secondary|Peak 15Nitrogen Nitro-conjugated Linoleic Acid (cLA) Concentrations Over 24 Hour Study Period|"Post-dose refers to that subjects will receive a single dose of each study drug, oral 15N-labeled sodium nitrate and nitrite, in random order, separated by a 3-7 day washout period"|measured at time 0 (trough), every 15 minutes during the first 2 hours post-dose, then at 3, 6, and 24 hours post-dose|maximal at 24 hours with nitrate treatment, not detectable with nitrite treatment|||nanoMolar||Full Range|Median
2648865|NCT01681836|Secondary|Peak Change in Diastolic Blood Pressure Over 24 Hour Study Period|"Post-dose refers to that subjects will receive a single dose of each study drug, oral 15N-labeled sodium nitrate and nitrite, in random order, separated by a 3-7 day washout period"|measured at 0 (baseline) then every 15 minutes during the first 2 hours post-dose, then at 3, 6, and 24 hours post-dose, change at 0.75 hours reported||||mmHg||Standard Error|Mean
2648866|NCT01681836|Secondary|Peak Change in Systolic Blood Pressure Over 24 Hour Study Period|"Post-dose refers to that subjects will receive a single dose of each study drug, oral 15N-labeled sodium nitrate and nitrite, in random order, separated by a 3-7 day washout period"|measured at 0 (baseline) then every 15 minutes during the first 2 hours post-dose, then at 3, 6, and 24 hours post-dose, change at 1.5 hours reported||||mmHg||Standard Error|Mean
2648867|NCT01681836|Secondary|Peak Change in Mean Arterial Pressure Over 24 Hour Study Period|"Post-dose refers to that subjects will receive a single dose of each study drug, oral 15N-labeled sodium nitrate and nitrite, in random order, separated by a 3-7 day washout period"|measured at 0 (baseline) then every 15 minutes during the first 2 hours post-dose, then at 3, 6, and 24 hours post-dose, change at 0.75 hours reported||||mmHg||Standard Error|Mean
2648972|NCT01681121|Other Pre-specified|Evaluate the Change From Baseline in the Median Number of Cataplectic Attacks Per Week for the Subset of Subjects With Cataplexy for ADX-N05 vs. Placebo at Week 4||4 weeks|||||||
2648871|NCT01681836|Primary|Peak Plasma Nitrate Concentration Over 24 Hour Study Period|"Post-doses refers to that subjects will receive a single dose of each study drug, oral 15Nitrogen(15N)-labeled sodium nitrate and nitrite, in random order, separated by a 3-7 day washout period"|measured at 0 (baseline), 0.5, 1, 2, 3, 6 and 24 hours post-doses||||microMolar (microM)||Standard Error|Mean
2648872|NCT01681810|Secondary|Peak Change in Methemoglobin Over 12 Week Study Period|Peak change in methemoglobin on sodium nitrite compared to baseline. Methemoglobin was assessed bi-weekly at study visits 30 minutes after directly observed nitrite dosing using noninvasive co-oximetry (Masimo Corp, Irvine, CA).|measured at 0 (baseline) and bi-weekly over 12 weeks||||percentage of total hemoglobin||Standard Error|Mean
2648873|NCT01681810|Secondary|Peak Change in Mean Arterial Pressure Over 12 Week Study Period|Peak change in mean arterial pressure (MAP) on sodium nitrite compared to baseline. Subjects performed bi-weekly blinded automated blood pressures with a Dinamap DPC200X (GE Medical Systems Information Technology) in triplicate at study visits beginning 30 minutes after directly observed nitrite dosing. Five minute intervals were maintained between measurements while in the supine position with legs uncrossed and sitting upright in a hospital bed in a quiet room. The final 2 of 3 MAP measurements were averaged.|measured at 0 (baseline) and bi-weekly over 12 weeks||||mmHg||Standard Error|Mean
2648874|NCT01681810|Secondary|Peak Change in Diastolic Blood Pressure Over 12 Week Study Period|Peak change in diastolic blood pressure (DBP) on sodium nitrite compared to baseline. Subjects performed bi-weekly blinded automated blood pressures with a Dinamap DPC200X (GE Medical Systems Information Technology) in triplicate at study visits beginning 30 minutes after directly observed nitrite dosing. Five minute intervals were maintained between measurements while in the supine position with legs uncrossed and sitting upright in a hospital bed in a quiet room. The final 2 of 3 DBP measurements were averaged.|measured at 0 (baseline) and bi-weekly over 12 weeks||||mmHg||Standard Error|Mean
2648875|NCT01681810|Secondary|Peak Change in Systolic Blood Pressure Over 12 Week Study Period|Peak change in systolic blood pressure (SBP) on sodium nitrite compared to baseline. Subjects performed bi-weekly blinded automated blood pressures with a Dinamap DPC200X (GE Medical Systems Information Technology) in triplicate at study visits beginning 30 minutes after directly observed nitrite dosing. Five minute intervals were maintained between measurements while in the supine position with legs uncrossed and sitting upright in a hospital bed in a quiet room. The final 2 of 3 SBP measurements were averaged.|measured at 0 (baseline) and bi-weekly over 12 weeks||||mmHg||Standard Error|Mean
2648876|NCT01681810|Primary|Change in Insulin Stimulated Glucose Disposal Over 12 Week Study Period|Change in insulin stimulated glucose disposal was assessed during the 4-hour hyperinsulinemic euglycemic clamp at end of the 12 weeks and was compared to baseline (pre-nitrite). Insulin stimulated glucose disposal (mg/min) was calculated in the final 20 minutes of the 4-hour clamp at steady state and expressed as mg per kg lean body mass (as measured by DEXA) per minute. HumuLIN R regular insulin was infused at a rate of 40 microUnits/m2/min. A non-radioactive glucose isotope dilution (Isotec, Inc) was delivered as a primed, then constant infusion of the 98+% enriched stable isotope of D-glucose [6,6-D2] (0.22 umol x kg-1, 17.6 umol x kg-1 prime). Plasma glucose was clamped between 85-95 mg/dL with a variable infusion of 20% dextrose in water. The rate of dextrose infusion was adjusted based on arterialized plasma glucose measurements obtained every 5 minutes.|measured at 0 (baseline) and at 12 weeks|The pre-drug hyperinsulinemic euglycemic clamp isotope data for 1 subject (used to determine insulin stimulated glucose disposal) was not interpretable despite repeat of the mass spectrometry assay. Therefore, the pre- and post- outcome measure for this subject was removed from analysis, giving a n=19 sample size for this analysis.|||mg/kg lean body mass/minute||Standard Error|Mean
2648877|NCT01681771|Primary|Depressive Symptoms|Depressive Symptoms measured with Patient Health Questionnaire-9 (PHQ-9). The number of patients per study arm is planned to be n=60. According to an earlier metaanalysis, the effect size of internet CBT intervention can be expected to be at least at the level of 0.5. The score on the PHQ-9 ranges from 0-27. A score between 5-10 indicate a mild depression whereas a score >10 indicate at least moderate depression.|9 weeks||||units on a scale||Standard Deviation|Mean
2648878|NCT01681628|Post-Hoc|Assessment of Continuing Benefit of TFT After 19 Months, in Control Group, as Measured by a Diagnosis of PTSD According to a PCL-C Score of >50.|PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. Only the wait-list control group was used as the treatment group did not not have a run-in score, and would have given inappropriately positive results.|Time 2 and 19 months later.|83% female average age 43 years, 17% male average age 46.7 years.|||percentage of PCL-C scores >50.|||Number
2648879|NCT01681628|Post-Hoc|Assessment of Any Persisting Benefit of TFT (Thought Field Therapy) After 19 Months.|PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C one week following treatment and nineteen months later. Comparison of PCL-C scores at nineteen months compared to one week following treatment.|1 week post-treatment (Time 2, TFT; Time 3, WL) and 19 months later.|All those who had scores one week after treatment and at 19 months. Similar gender and age proportions to original groups.|||units on a scale (PCL-C score)||Standard Deviation|Mean
2648890|NCT01681511|Secondary|The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI)|Patients with catheter related SUTI are those having an indwelling urinary catheter in place at the time of specimen collection, or had an indwelling catheter within the previous 48 hours, and at least 1 of the following signs or symptoms with no other recognized cause: fever (>38°C), suprapubic tenderness, or costovertebral angle pain or tenderness and a positive urinalysis demonstrated by at least one of the following findings: a. positive dipstick for leukocyte esterase and/or nitrite, b. pyuria (urine specimen collected from the catheter with ≥10 white blood cells [WBC]/mm3 or ≥3 WBC/high power field of unspun urine), c. microorganisms seen on Gram stain of unspun urine and a positive urine|up to 30th day from the time of catheterization||||Participants|||Number
2648880|NCT01681628|Secondary|Percentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C > 50) Before and After Treatment in Treatment and Control Groups.|PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. The wait list group received no treatment at Time 1.|Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)|Participants with symptoms suggestive of PTSD, thought field therapy group treated, wait list group not treated, and wait-list group treated. All assessed one week after initial assessment and treatment, and the percentage with a score > 50 compared before and after treatment, or control.|||percentage with PCL-C score > 50|||Number
2648881|NCT01681628|Primary|Change in Post-traumatic Stress Disorder Check List for Civilians (PLC-C) Score.|"PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. The wait list group received no treatment at Time 1.~In the treatment arm, measure immediately pre-treatment (baseline) (time 1) and one week later (time 2).~In the wait-list no therapy arm, measure at baseline (time 1), and after one week (no treatment) (time 2). The wait-list group (Thought Field Therapy group) were then treated and reassessed after a further week (time 3)."|Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)|Participants with symptoms suggestive of PTSD, excluding non-attenders at Time 2. Non-attenders at time 3 were excluded from the wait-list (Thought Field Therapy) arm.|||units on a scale||Standard Deviation|Mean
2648882|NCT01681576|Secondary|Mean Sitting Pulse Pressure (PP) Over Time|Sitting mean pulse pressure rate was calculated between ambulatory SBP and DBP measurements|Day-1, Day 14 and Day 28|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.|||mmHg||Standard Deviation|Mean
2648883|NCT01681576|Secondary|Seated Office Blood Pressure (BP) (Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)) Over Time|Seated Office BP (systolic blood pressure (SBP) and diastolic blood pressure (DBP))measurements will be performed at trough(immediately prior to dosing at the clinic). Arterial BP readings will be made with an automated BP device.|Day-1, Day 14 and Day 28|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.|||mmHg||Standard Deviation|Mean
2648884|NCT01681576|Secondary|Urine Volume (Diuresis) Over Time|Urine will be collected and volume measured in fractions of 0 to 6 hours and 0 to 24 hours Day-1, Day 1 and Day 28|Day -1, Day 1 & Day 28|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.|||mL||Standard Deviation|Mean
2648885|NCT01681576|Secondary|Cumulative Sodium Excretion (Natriuresis) at Day 28|Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 28|0-6 and 0-24 hours on Day 28|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.|||mmol||Standard Deviation|Mean
2648886|NCT01681576|Primary|Cumulative Sodium Excretion (Natriuresis) at Day 1|Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium Day 1|0-6 and 0-24 hours on Day 1|Pharmacodynamic PD analysis set: Patients with any available PD data, who received any study drug and experienced no protocol deviations with relevant impact on PD data.|||mmol||Standard Deviation|Mean
2648887|NCT01681511|Other Pre-specified|Organism Relation to CAUTI and TIC|Organisms found in relation to CAUTI events in TIC versus control.|up to 30th day from the time of catheterization||||participants|||Number
2648888|NCT01681511|Primary|The Proportion of Subjects With at Least One CAUTI|"CAUTI is as determined by blinded investigator assessment per protocol definition.~DAYS TO CAUTI = (DATE OF EVENT - DATE OF CZD INSERTION) + 1. Date of event for subjects who had CAUTI is the date of urine sample collection where the CAUTI criteria are met.~Date of event for subjects who did not have CAUTI is the last available urine culture collection date from samples collected during & post CZD.~p-values of time of CAUTI were obtained from log-rank test. p-values of Incidence of CAUTI were obtained from the Logistic Regression Model.~Evaluable population (EP) refers to all randomized subjects successfully CZD & stayed on the CZD for ≥ 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting >24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP.~CZD = Catheterized or catheter"|48 ± 24 hours or more||||participants|||Number
2648889|NCT01681511|Secondary|The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI)|Patients having an indwelling urinary catheter who have no signs or symptoms (i.e., no fever (>38°C), no urgency, frequency, dysuria, suprapubic tenderness, or costovertebral angle pain or tenderness), and a positive urine culture from urine collected from the catheter sampling port (or a midstream voided clean catch urine in subjects being followed for 48 hours post catheter removal) of >105 CFU/ml with no more than 2 species of uropathogen microorganisms and a positive blood culture with at least 1 matching uropathogen microorganism to the urine culture.|up to 30th day from the time of catheterization||||participants|||Number
2648904|NCT01681472|Secondary|T(Last) of [6S]-5-methyl-THF|The time-point for the last measurable concentration for the metabolite [6S]-5-methyl-THF in plasma|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||h||Standard Deviation|Mean
2648905|NCT01681472|Secondary|T(Last) of [6S]-5-THF|The time-point for the last measurable concentration for the metabolite [6S]-5-TH in plasma|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||h||Standard Deviation|Mean
2648891|NCT01681511|Primary|Number of Subjects Affected, During Treatment and Follow-up Time Periods, by a Catheter Associated Urinary Tract Infection (CAUTI) Event After First CAUTI Event.|"All randomized subjects will be followed until (1) up to 30th day from the time of catheterization or (2) the subject withdraws or is discharged from the hospital, whichever comes first and (3) 48 hours after the catheter is removed.~Evaluable population (EP) refers to all randomized subjects successfully CZD & stayed on the CZD for ≥ 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting >24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP."|up to 30th day from the time of catheterization||||participants|||Number
2648892|NCT01681472|Secondary|Number of AEs Per Severity|Number of reported AEs per treatment with respect to severity|Screening visit until end of study, Day 5|The safety population contained 31 of the 32 enrolled patients. One patient randomized to L-LV 60 mg/m2 was withdrawn prior to study drug administration and thus excluded from the safety analysis set.|||Events|||Number
2648893|NCT01681472|Secondary|Change in S-Folate Concentration From Screening|Blood samples for folate biomarker (S-folate) analysis were collected at Screening, Day 2 and Day 5 (End of study visit). Changes from screening to later visits were counted.|Samples taken at Screening visit, Day 2 and End of Study (Day 5)|The Per Protocol analysis set contained 29 of the 32 enrolled patients. One patient was withdrawn prior to study drug administration and two patients were excluded due to major protocol deviations.|||Participants|||Count of Participants
2648894|NCT01681472|Secondary|Change in Homocystein Concentration From Screening|"Blood samples for folate biomarker (homocystein) analysis were collected at Screening, Day 2 and Day 5 (End of study visit). Changes from screening to later visits were counted.~The criteria for assessment categories normal, low and high were based on the reference ranges for plasma-Homocystein as follows: low <4,7 mcmol/L; normal => 4,7 and <=16 mcmol/L; high >16 mcmol/L. Values were applicable for both male and female adults."|Samples taken at Screening visit, Day 2 and End of Study (Day 5)|The Per Protocol analysis set contained 29 of the 32 enrolled patients. One patient was withdrawn prior to study drug administration and two patients were excluded due to major protocol deviations.|||Participants|||Count of Participants
2648895|NCT01681472|Secondary|S-Folate Concentration|Blood samples for folate biomarker (S-folate) analysis were collected at Screening, Day 2 and Day 5 (End of study visit).|Samples taken at Screening visit, Day 2 and End of Study (Day 5)|The Per Protocol analysis set contained 29 of the 32 enrolled patients. One patient was withdrawn prior to study drug administration and two patients were excluded due to major protocol deviations.|||nmol/L||Standard Deviation|Mean
2648896|NCT01681472|Secondary|Homocystein Concentration|Blood samples for folate biomarker (homocystein) analysis were collected at Screening, Day 2, and Day 5 (End of study visit).|Samples taken at Screening visit, Day 2, and End of Study (Day 5)|The Per Protocol analysis set contained 29 of the 32 enrolled patients. One patient was withdrawn prior to study drug administration and two patients were excluded due to major protocol deviations.|||μmol/L||Standard Deviation|Mean
2648897|NCT01681472|Secondary|Correlation of Gene Expression in Tumor and Adjacent Mucosa|Concentration of the gene expression was analysed in both tumor and adjacent mucosa. The presence of any correlation between the results (i.e., concentration of the gene expression in tumor versus adjacent mucosa) was evaluated for each treatment. No evaluation was done between treatments.|Sample taken Day 1 (Day of Surgery)|The Per Protocol analysis set contained 29 of the 32 enrolled patients. One patient was withdrawn prior to study drug administration and two patients were excluded due to major protocol deviations.|||Normalized concentration|||Number
2648898|NCT01681472|Secondary|Gene Expression Ratios (Mucosa:Tumor)|Concentration of different genes involved in folate transport and metabolism were analysed in both tumor and adjacent mucosa. The concentration in mucosa was divided by the concentration in tumor. A value above 1 indicate that the gene expression was higher in mucosa than in tumor and a value below 1 that the gene expression was higher in tumor than in mucosa.|Sample taken Day 1 (Day of Surgery)|The Per Protocol analysis set contained 29 of the 32 enrolled patients. One patient was withdrawn prior to study drug administration and two patients were excluded due to major protocol deviations.|||Ratio|||Number
2648899|NCT01681472|Secondary|Correlation Between Plasma and Tissue Concentration (Tumor and Mucosa) for [6S]-5-formyl-THF|Correlation between the exposure of [6S]-5-formyl-THF following 2 hours after dosing (AUC[0-2h]) and the concentration of [6S]-5-formyl-THF in the tumor or adjacent mucosa at surgery.|Samples taken Day 1 (Day of surgery)|The Per Protocol analysis set contained 29 of the 32 enrolled patients. One patient was withdrawn prior to study drug administration and two patients were excluded due to major protocol deviations.|||correlation coefficient|||Number
2648900|NCT01681472|Secondary|Correlation Between Plasma and Tissue Concentration (Tumor and Mucosa) for [6S]-5-methyl-THF|Correlation between the exposure of [6S]-5-methyl-THF following 2 hours after dosing (AUC[0-2h]) and the concentration of [6S]-5-methyl-THF in the tumor or adjacent mucosa at surgery.|Samples taken Day 1 (Day of surgery)|The Per Protocol analysis set contained 29 of the 32 enrolled patients. One patient was withdrawn prior to study drug administration and two patients were excluded due to major protocol deviations.|||correlation coefficient|||Number
2648901|NCT01681472|Secondary|Correlation Between Plasma and Tissue Concentration (Tumor and Mucosa) for [6S]-5-THF|Correlation between the exposure of [6S]-5-THF following 2 hours after dosing (AUC[0-2h]) and the concentration of [6S]-5-THF in the tumor or adjacent mucosa at surgery.|Samples taken Day 1 (Day of surgery)|The Per Protocol analysis set contained 29 of the 32 enrolled patients. One patient was withdrawn prior to study drug administration and two patients were excluded due to major protocol deviations.|||correlation coefficient|||Number
2648902|NCT01681472|Secondary|Correlation Between Plasma and Tissue Concentration (Tumor and Mucosa) for [6R]-5,10-methylene-THF|Correlation between the exposure of [6R]-5,10-methylene-THF following 2 hours after dosing (AUC[0-2h]) and the concentration of [6R]-5,10-methylene-THF in the tumor or adjacent mucosa at surgery.|Samples taken Day 1 (Day of surgery)|The Per Protocol analysis set contained 29 of the 32 enrolled patients. One patient was withdrawn prior to study drug administration and two patients were excluded due to major protocol deviations.|||correlation coefficient|||Number
2648903|NCT01681472|Secondary|T(Last) of [6S]-5-formyl-THF|The time-point for the last measurable concentration for the metabolite [6S]-5-formyl-THF in plasma|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||h||Standard Deviation|Mean
2648907|NCT01681472|Secondary|T(1/2) of [6S]-5-formyl-THF|Terminal plasma elimination half-life time for the metabolite [6S]-5-formyl-THF|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||h||Standard Deviation|Mean
2648908|NCT01681472|Secondary|T(1/2) of [6S]-5-methyl-THF|Terminal plasma elimination half-life time for the metabolite [6S]-5-methyl-THF|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||h||Standard Deviation|Mean
2648909|NCT01681472|Secondary|T(1/2) of [6S]-5-THF|Terminal plasma elimination half-life time for the metabolite [6S]-5-THF|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||h||Standard Deviation|Mean
2648910|NCT01681472|Secondary|T(1/2) of [6R]-5,10-methylene-THF|Terminal plasma elimination half-life time for the active substance in Modufolin: [6R]-5,10-methylene-THF|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||h||Standard Deviation|Mean
2648911|NCT01681472|Secondary|Tmax of [6S]-5-formyl-THF|Timepoint (tmax) when Cmax in plasma occurs for the metabolite [6S]-5-formyl-THF|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||h||Standard Deviation|Mean
2648912|NCT01681472|Secondary|Tmax of [6S]-5-methyl-THF|Timepoint (tmax) when Cmax in plasma occurs for the metabolite [6S]-5-methyl-THF|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||h||Standard Deviation|Mean
2648913|NCT01681472|Secondary|Tmax of [6S]-5-THF|Timepoint (tmax) when Cmax in plasma occurs for the metabolite [6S]-5-THF|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||h||Standard Deviation|Mean
2648914|NCT01681472|Secondary|Tmax of [6R]-5,10-methylene-THF|Timepoint (tmax) when Cmax in plasma occurs of the active substance in Modufolin: [6R]-5,10-methylene-THF|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||h||Standard Deviation|Mean
2648915|NCT01681472|Secondary|Cmax of [6S]-5-formyl-THF in Plasma|Maximum concentration (Cmax) in plasma of the active substance in Modufolin: [6R] 5,10- methylene-THF and the metabolites: [6S]-5-THF, [6S]-5-methyl-THF, and [6S]-5-formyl-THF|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||µg/L||Standard Deviation|Mean
2648916|NCT01681472|Secondary|Cmax of [6S]-5-methyl-THF in Plasma|Maximum concentration (Cmax) in plasma of the metabolite [6S]-5-methyl-THF|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||µg/L||Standard Deviation|Mean
2648917|NCT01681472|Secondary|Cmax of [6S]-5-THF in Plasma|Maximum concentration (Cmax) in plasma of the metabolite [6S]-5-THF|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||µg/L||Standard Deviation|Mean
2648918|NCT01681472|Secondary|Cmax of [6R]-5,10-methylene-THF|Maximum concentration (Cmax) in plasma of the active substance in Modufolin: [6R]-5,10-methylene-THF|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||µg/L||Standard Deviation|Mean
2648919|NCT01681472|Secondary|AUC(Last) of [6S]-5-formyl-THF|Area under the plasma concentration versus time curve, from time 0 to the last time point, for the metabolite [6S]-5-formyl-THF|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||mcg*h/L||Standard Deviation|Mean
2648920|NCT01681472|Secondary|AUC(Last) of [6S]-5-methyl-THF|Area under the plasma concentration versus time curve, from time 0 to the last time point, for the metabolite [6S]-5-methyl-THF|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||mcg*h/L||Standard Deviation|Mean
2648921|NCT01681472|Secondary|AUC(Last) of [6S]-5-THF|Area under the plasma concentration versus time curve, from time 0 to the last time point, for the metabolite [6S]-5-THF|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||mcg*h/L||Standard Deviation|Mean
2648922|NCT01681472|Secondary|AUC(Last) of [6R]-5,10-methylene-THF|Area under the plasma concentration versus time curve, from time 0 to the last time point, for the active substance in Modufolin: [6R]-5,10-methylene-THF|Samples taken Day 1 (Day of surgery) and Day 2|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||mcg*h/L||Standard Deviation|Mean
2648923|NCT01681472|Secondary|AUC(0-2h) of [6SR]-5-formyl-THF|Area under the plasma concentration versus time curve from time 0 to 2 hours, for the metabolite [6S]-5-formyl-THF|Samples taken Day 1 (Day of surgery)|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||mcg*h/L||Standard Deviation|Mean
2648924|NCT01681472|Secondary|AUC(0-2h) of [6S]-5-methyl-THF|Area under the plasma concentration versus time curve from time 0 to 2 hours, for the metabolite: [6S]-5-methyl-THF|Samples taken Day 1 (Day of surgery)|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||mcg*h/L||Standard Deviation|Mean
2648925|NCT01681472|Secondary|AUC(0-2h) of [6S]-5-THF|Area under the plasma concentration versus time curve from time 0 to 2 hours, for the metabolite [6S]-5-THF|Samples taken Day 1 (Day of surgery)|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||mcg*h/L||Standard Deviation|Mean
2648926|NCT01681472|Secondary|AUC(0-2h) of [6R]-5,10-methylene-THF|Area under the plasma concentration versus time curve from time 0 to 2 hours, for the active substance in Modufolin: [6R]-5,10-methylene-THF|Samples taken Day 1 (Day of surgery)|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||mcg*h/L||Standard Deviation|Mean
2648927|NCT01681472|Primary|Concentration of [6S]-5-formyl-THF in Adjacent Mucosa Tissue|Comparison of concentration of the metabolite [6S]-5-formyl-THF in mucosa adjacent to the tumor after the different treatments.|Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||pmol/g||Standard Deviation|Mean
2648928|NCT01681472|Primary|Concentration of [6S]-5-formyl-THF in Tumor Tissue|Comparison of concentration of the metabolite [6S]-5-formyl-THF in tumor after the different treatments.|Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||pmol/g||Standard Deviation|Mean
2648929|NCT01681472|Primary|Concentration of [6S]-5-methyl-THF in Adjacent Mucosa Tissue|Comparison of concentration of the metabolite [6S]-5-methyl-THF in mucosa adjacent to the tumor after the different treatments.|Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||pmol/g||Standard Deviation|Mean
2648930|NCT01681472|Primary|Concentration of [6S]-5-methyl-THF in Tumor Tissue|Comparison of concentration of the metabolite [6S]-5-methyl-THF in tumor after the different treatments.|Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||pmol/g||Standard Deviation|Mean
2648931|NCT01681472|Primary|Concentration of [6S]-5-THF in Adjacent Mucosa Tissue|Comparison of concentration of the metabolite [6S]-5-THF in mucosa adjacent to the tumor after the different treatments.|Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||pmol/g||Standard Deviation|Mean
2648932|NCT01681472|Primary|Concentration of [6S]-5-THF in Tumor Tissue|Comparison of concentration of the metabolite [6S]-5-THF in tumor after the different treatments.|Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||pmol/g||Standard Deviation|Mean
2648933|NCT01681472|Primary|Concentration of [6R]-5,10-methylene-THF in Adjacent Mucosa Tissue|Comparison of concentration of the active substance in Modufolin: [6R]-5,10-methylene-THF in mucosa adjacent to the tumor after the different treatments.|Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||pmol/g||Standard Deviation|Mean
2648934|NCT01681472|Primary|Concentration of [6R]-5,10-methylene-THF in Tumor Tissue|Comparison of concentration of the active substance in Modufolin: [6R]-5,10-methylene-THF in tumor tissue after the different treatments.|Sample taken Day 1 (Day of surgery) at 0 min (before anesthetics) and 5, 10, 20, 40, 60, 90, 120, 180, 240, 360 min after study drug administration, and 24 h after study drug administration|Per protocol population, all patients who complete the trial without any major deviations from the protocol procedure.|||pmol/g||Standard Deviation|Mean
2648935|NCT01681433|Other Pre-specified|Phosphatase and Tensin Homolog (PTEN) Deletion Status|Compare arms to determine PTEN deletion status in original pathology specimens correlated with clinical outcomes|Every 4 weeks|Data for this objective was not collected or analyzed||||||
2648936|NCT01681433|Other Pre-specified|Protein Levels|Compare arms to determine levels of heat shock protein 27 (Hsp27), clusterin, and other relevant proteins of patients at baseline and during study|Every 4 weeks|Data for this secondary objective was not collected or analyzed||||||
2648937|NCT01681433|Other Pre-specified|Circulating Tumor Cell (CTC) Counts|Compare arms to determine circulating tumor cell (CTC) counts for patients at baseline and while on study|Every 4 weeks||||participants|||Number
2648938|NCT01681433|Other Pre-specified|Time to Disease Progression|Compare arms to determine the time to disease progression of study patients|60 days||||months||95% Confidence Interval|Median
2648939|NCT01681433|Other Pre-specified|Objective Response|Compare arms to determine the objective response of study patients, per RECIST 1.1|60 days||||participants|||Number
2648940|NCT01681433|Secondary|PSA Response|Compare arms to determine the proportion of patients who have a PSA response (≥ 30% decline) and any PSA decline post-randomization.|60 days||||participants|||Number
2648941|NCT01681433|Primary|Progression-Free Survival|To ascertain whether Arm A has a greater proportion of patients observed to be alive without progression at Day 60 (±7 days) as compared to Arm B.|60 days||||participants|||Number
2648942|NCT01681368|Secondary|Total Clearance of Birinapant After Administration|Clearance is a quantitative measure of the rate at which a drug substance is removed from the body.|0-24hr||||L/hr||Full Range|Mean
2648943|NCT01681368|Secondary|Coexpression of Cleaved Caspase 3 and Gamma-H2AX in Fixed Specimens|Tumor biopsies were measured for cleaved caspase 3 and gamma-H2A.X by immunofluorescence microscopy. Fold change was calculated by comparing the post-treatment measurements to the pre-treatment levels.|Pre treatment and post treatment of Birinapant, approximately 0-6 weeks|Only 2 pairs of adequate pre- and post-treatment biopsy samples were available for analysis. The remaining paired samples were inadequate for immunohistochemistry because of necrotic debris in the post-treatment biopsy sample (1 specimen) or contamination with blood (4 specimens).|||Fold over baseline||Full Range|Median
2648973|NCT01681121|Secondary|Evaluate the Safety and Tolerability of ADX-N05 vs Placebo in Adults With Narcolepsy by Assessing Treatment Emergent Adverse Events, Vital Signs, Laboratory Results, ECGs, and Physical Exams.||12 weeks|||||||
2648974|NCT01681121|Secondary|Evaluate the Patient Global Impression-Change Scores for ADX-N05 vs. Placebo at Last Assessment||12 weeks|||||||
2648944|NCT01681368|Secondary|Ratio of Phosphorylated NF-kappaB-p65 Protein to Total NF-kappaBp65 Protein in Tumor Biopsy Samples|Proteins were measured using capillary western blot and ratio was calculated between phosphorylated and total NF-kappaB p65. Core 1 tumor samples and peripheral blood mononuclear cells (PBMCs) from each time point were lysed in T-PER buffer (Thermo Scientific) for protein quantification by an automated capillary electrophoresis immunoassay system (Simple Western). The tumor protein lysate (40-60 ng) or PBMC protein lysate (16-77 ng) was analyzed according to the manufacturer's instructions (ProteinSimple, Santa Clara, Calif).|0-6 weeks|4 patients refused second biopsy.|||pixel intensity per ng protein||Full Range|Mean
2648945|NCT01681368|Secondary|Calculated Volume of Distribution of Birinapant at Steady State (Vss) in Plasma|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0-24hr||||L||Standard Deviation|Mean
2648946|NCT01681368|Secondary|Calculated Volume of Distribution of Birinapant at Steady State (Vss) in Tumor Tissue|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|0-24hr||||L||Full Range|Mean
2648947|NCT01681368|Secondary|Birinapant Concentration in Tumor Tissue|Levels of Birinapant were measured in core needle biopsies of tumor that had been frozen at the time of acquisition.|Prior to treatment and 12 to 22 hours following Cycle 2 Day 15|4 patients did not have the second paired biopsy due to patient refusal.|||ng/g||Full Range|Mean
2648948|NCT01681368|Secondary|Mean Plasma Concentration-Time Curve of Birinapant|Measurement of the plasma concentration of the Birinapant over time. It is used to characterize drug absorption. The single values were analyzed with liquid chromatography/tandem mass spectrometry via a proprietary methodology (TetraLogic Pharma,Malvern, Pa). The values were grouped and averaged for each of the patients to obtain the mean value for each time point.|30, 60, 120, 180 minutes after administration of first dose of Birinapant||||ng/mL||Standard Deviation|Mean
2648949|NCT01681368|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|8 months||||participants|||Number
2648950|NCT01681368|Primary|Objective Response (Complete Response (CR) or Partial Response (PR) Defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Criteria) or Disease Stabilization for Greater Than 6 Months|Per the RECIST criteria, CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|6 months||||participants|||Number
2648951|NCT01681277|Secondary|RA,AUC|Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval t, expressed as ratio of AUC at steady state and after single dose (RA,AUC).|-2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.|PKS|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2648952|NCT01681277|Secondary|RA,Cmax|Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval t, expressed as ratio of Cmax at steady state and after single dose (RA,Cmax).|-2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.|PKS|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2648953|NCT01681277|Secondary|t1/2,ss|Terminal half-life of the analyte in plasma at steady state (t1/2,ss).|311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 360h, 384h after last dose.|PKS|||h||Geometric Coefficient of Variation|Geometric Mean
2648954|NCT01681277|Secondary|AUCtau,ss|Area under the concentration-time curve of the analyte BI 113608 in plasma at steady state over a uniform dosing interval t (AUCtau,ss).|311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.|PKS|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2648955|NCT01681277|Secondary|Tmax,ss|Time from last dosing to maximum concentration of the analyte in plasma at steady state (tmax,ss).|311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.|PKS|||h||Full Range|Median
2648956|NCT01681277|Secondary|Cmax,ss|Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).|311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.|PK analysis set (PKS): This set included all subjects of the TS who provided at least one observation for at least one secondary PK endpoint without important protocol violations.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2648957|NCT01681277|Primary|Number of Participants With Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, and ECG Recordings|Number of participants with Clinically relevant abnormalities for clinical laboratory tests (haematology, clinical chemistry and urinalysis), vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), body temperature), and 12- lead electrocardiogram (ECG)|From administration of study drug until end-of-study, up to 17 days|Treated Set (TS)|||participants|||Number
2648958|NCT01681277|Primary|Percentage of Participants With Drug-related Adverse Events|Percentage of participants with drug-related adverse events|From administration of study drug until end-of-study, up to 17 days|Treated set|||percentage of participants|||Number
2648975|NCT01681121|Secondary|Evaluate the Patient Global Impression-Change Scores for ADX-N05 vs. Placebo at Week 4||4 weeks|||||||
2648976|NCT01681121|Secondary|Evaluate the Clinical Global Impression-Change Scores for ADX-N05 vs. Placebo at Week 4||4 weeks|||||||
2648977|NCT01681121|Secondary|Evaluate the Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual Maintenance of Wakefulness Test Trials for ADX-N05 vs. Placebo at Last Assessment||12 weeks|||||||
2648959|NCT01681212|Secondary|Number of Patients Who Died and Who Had Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, Grade 3-4 AEs, and Related Grade 3-4 AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling; Grade 5=death.|First dose to 90 days following last dose of study drug. All deaths were poststudy, occurring more than 90 days after the last dose of study drug.|All participants who received at least 1 dose of study drug|||Participants|||Number
2648960|NCT01681212|Secondary|Number of Participants With Grade 3-4 Immune-related Adverse Events (irAEs)|irAEs are adverse events of unknown cause, consistent with an immune phenomenon, and considered to be causally related to drug exposure. Six subcategories of irAE are assessed: gastrointestinal, liver, skin, endocrine, neurologic, and other. The irAEs are programmatically determined from a predefined list of MedDRA terms. irAEs will be measured every 3 weeks in induction phase, every 6 weeks in Maintenance Phase to Week 48, and every 12 weeks until Progressive Disease. Grading criteria: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|First dose to 90 days following last dose of study drug|All participants who received at least 1 dose of study drug|||Participants|||Number
2648961|NCT01681212|Primary|Percentage of Participants Surviving at 1 Year|Survival rate=percentage of participants surviving at 1 year following start of study drug. Every effort was made to collect survival data on all patients, including those withdrawn from treatment for any reason. If the death of a patient was not reported, the patient's last known alive date was recorded. Confidence intervals were computed using the Clopper-Pearson method.|At 1 year from start of study drug|All participants who received at least 1 dose of study drug.|||Percentage of participants||90% Confidence Interval|Number
2648962|NCT01681186|Secondary|Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)]|Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)]|Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug|Analysis was based on the number of randomized participants who received LY2940680 and had evaluable PK data during Part B of the study.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2648963|NCT01681186|Secondary|Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)]|Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)]|Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug|Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2648964|NCT01681186|Secondary|Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)]|Part B: Pharmacokinetics: Area Under the Curve from Time Zero to Time T, where T is the Last Time Point with a Measurable Concentration [AUC(0-tlast)]|Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug|Analysis was based on the number of randomized participants who received LY2940680 who had evaluable PK data during Part B of the study.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2648965|NCT01681186|Secondary|Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)]|Part A: Pharmacokinetics: Area Under the Curve from Time Zero to Time T, where T is the Last Time Point with a Measurable Concentration [AUC(0-tlast)]|Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug|Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2648966|NCT01681186|Secondary|Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax)|Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (tmax)|Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug|Analysis was based on the number of randomized participants who received LY2940680 and had evaluable PK data during Part B of the study.|||hours (h)||Full Range|Median
2648967|NCT01681186|Secondary|Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax)|Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (tmax)|Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug|Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study.|||hours (h)||Full Range|Median
2648968|NCT01681186|Secondary|Part A: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax)|The Cmax of LY2940680 during Part A of the study was reported.|Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug|Analysis was based on the number of randomized participants who received LY2940680 during Part A of the study.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2648969|NCT01681186|Primary|Part B: Pharmacokinetics: Maximum Observed Concentrations (Cmax) of LY2940680 Test and Reference Formulation|The Cmax of 100-milligram (mg) LY2940680 capsule (reference formulation) and 100-mg LY2940680 tablet (test formulation) in fasted and fed state, and with lansoprazole during Part B of the study.|Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours after administration of study drug|Analysis was based on the number of randomized participants in Part B of the study with evaluable Cmax data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2648970|NCT01681186|Primary|Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs|Data presented are the number of participants with AEs or any serious AEs (SAEs) regardless of causality. A summary of non-serious AEs is located in the Reported Adverse Events section.|Baseline through study completion (up to 4 weeks in Part A and 8 weeks in Part B)|All randomized participants.|||Participants|||Count of Participants
2648971|NCT01681121|Other Pre-specified|Evaluate the Change From Baseline in the Median Number of Cataplectic Attacks Per Week for the Subset of Subjects With Cataplexy for ADX-N05 vs. Placebo at Last Assessment||12 weeks|||||||
2648983|NCT01681121|Primary|Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test for ADX-N05 vs. Placebo at Last Assessment.|Sleep Latency - The primary analysis was a comparison of treatments vs. control groups on change from Baseline to last available post-Baseline assessment (Week 12/Last Assessment) in the average sleep latency time (in minutes) averaged across the first four trials of the MWT using a two-sample t-test.|Baseline and 12 weeks|93 subject were randomly assigned to a treatment group; 90 subjects (43 on ADX-N05 and 47 on Placebo) had at least one post-Basdeline efficacy assessment (Intent-to-treat [ITT] Population). For the primary endpoint analysis (40 on ADX-N05 and 45 on Placebo) have assessment week 12/last assessment|||Minutes||Standard Deviation|Mean
2648984|NCT01681095|Secondary|Cardiac Marker - Troponin-I|Troponin-I measured 48 hours post-operative|48 hours post procedure|Only patients for whom 48-hour Troponin-I values were available were included in analysis|||ng/mL||Standard Deviation|Mean
2648985|NCT01681095|Secondary|Cardiac Marker - Troponin-I|Troponin-I measured 24 hours post-operative|24 hours post procedure|Only patients for whom 24-hour Troponin-I values were available were included in analysis|||ng/mL||Standard Deviation|Mean
2648986|NCT01681095|Secondary|Cardiac Marker - Troponin-I|Troponin-I measured pre-operatively|pre-operatively|Only patients for whom preoperative Troponin-I values were available were included in analysis|||ng/mL||Standard Deviation|Mean
2648987|NCT01681095|Secondary|Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB)|CK-MB measured 48 hours post-operatively|48 hours post procedure|Only patients for whom 48 hour CK-MB values are available are included in analysis|||ng/mL||Standard Deviation|Mean
2648988|NCT01681095|Secondary|Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB)|CK-MB measured 24 hours post-operatively|24 hours post procedure|Only patients for whom 24 hour CK-MB values were available were analyzed|||ng/mL||Standard Deviation|Mean
2648989|NCT01681095|Secondary|Biochemical Marker - Creatine Kinase MB Isoenzyme (CK-MB)|CK-MB measured pre-operatively|pre-operative|Only patients for whom preoperative CK-MB levels were available were analyzed|||ng/mL||Standard Deviation|Mean
2648990|NCT01681095|Secondary|Myocardial Infarction|Number or participants fulfilling at least two of the following 3 criteria: (1) CK-MB of 100 ug/L or more and/or troponin-I of 3.0 ug/L or more, (2) appearance of new postoperative Q waves on the EKG of more than 0.03 seconds, and (3) a new hypokinetic or akinetic area in the left or right ventricle by echocardiography.|up to 36 hours post procedure||||participants|||Number
2648991|NCT01681095|Secondary|Intensive Care Unit (ICU) Length of Stay|Duration of stay in ICU, from ICU admission to ICU discharge|up to 100 days after admission||||days||Inter-Quartile Range|Median
2648992|NCT01681095|Secondary|Postoperative Inotropic Infusion >20 Minutes|Number of patients receiving vasopressor or inotropic infusion for greater than 20 minutes in the operating room, including norepinephrine, epinephrine, vasopressin, milrinone, dobutamine, dopamine and/or neo-synephrine.|during operative procedure||||participants|||Number
2648993|NCT01681095|Secondary|Duration of Vasopressor / Inotropic Agent|Total time in minutes on any vasopressor or inotropic agent, including norepinephrine, epinephrine, vasopressin, milrinone, dobutamine, dopamine and/or neo-synephrine|up to 36 hours post procedure|Patients not receiving any vasopressors are excluded from this analysis|||minutes||Inter-Quartile Range|Median
2648994|NCT01681095|Secondary|Time on Mechanically Assisted Ventilation|time in hours from intubation to extubation, with intervening transport to the cardiac critical care unit.|up to 36 hours post procedure||||hours||Inter-Quartile Range|Median
2648995|NCT01681095|Secondary|Cardiovascular Mortality|Number of participants with cardiovascular-related mortality AS reported in the Society of Thoracic Surgeons (STS) database after 30 days postoperative|30 days post procedure||||participants|||Number
2648996|NCT01681095|Secondary|All Cause Mortality|Number of participants with all-cause mortality AS reported in the Society of Thoracic Surgeons (STS) database after 30 days postoperative|30 days post procedure||||participants|||Number
2648997|NCT01681095|Secondary|Cardiac Dysrhythmias|Number of participants with new or worsening of cardiac dysrhythmias|up to 36 hrs post surgery||||participants|||Number
2648998|NCT01681095|Primary|Changes in Left Ventricular (LV) Ejection Fraction (EF) by Transthoracic Echocardiogram (TTE)|LV ejection fraction by TTE, difference from baseline at 24 hours post surgery|Baseline and 24 hours post surgery|patients for whom both preoperative and 24 hour LV ejection fractions were obtained|||% LV volume||Standard Deviation|Mean
2648999|NCT01681095|Primary|Change in Troponin I|Troponin I values, difference from baseline 7 hours post surgery|Baseline and 7 hours post surgery||||ng/mL||Inter-Quartile Range|Median
2649000|NCT01681095|Primary|Change in Creatine Phosphokinase-MB Isoenzyme (CK-MB)|Creatine phosphokinase MB isoenzyme (CK-MB) difference from baseline 7 hours post surgery|Baseline and 7 hours post surgery|Patients for which both baseline and 7 hours post surgery values were available|||ng/mL||Inter-Quartile Range|Median
2649001|NCT01681069|Secondary|Change in Mean Body Fat at End of Study From Baseline|Measured in kg using calibrated weighing scales|12 weeks||||kg||Standard Deviation|Mean
2649002|NCT01681069|Secondary|Change in Waist Circumference (in cm) at End of Study From Baseline|Difference in waist circumference (in cm) at end of study from baseline|12 weeks||||cm||Standard Deviation|Mean
2649003|NCT01681069|Primary|Change in Body Weight at End of Study Compared to Baseline|Change in body weight at the end of study compared to baseline|12 weeks||||kg||Standard Deviation|Mean
2649004|NCT01681030|Secondary|Number of Participants With Adverse Events Potentially Related to Thrombotic Events|The number of subjects with an adverse event potentially related to a thrombotic event|30 days (+ 14 days) following surgery||||Participants|||Count of Participants
2649005|NCT01681030|Secondary|Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment|The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had re-bleeding requiring treatment|Intra-operative, prior initiation of final chest wall closure. Safety Issue:|Subjects who established TBS hemostasis at 3 minutes|||Participants|||Count of Participants
2649006|NCT01681030|Secondary|Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application|Number of subjects achieving hemostatic success at 10 minutes following treatment application.|Intraoperative, 10 minutes following treatment application||||Participants|||Count of Participants
2649007|NCT01681030|Secondary|Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application|The number of subjects achieving hemostatic success at 6 minutes following treatment application.|Intraoperative, 6 minutes following treatment application||||Participants|||Count of Participants
2649008|NCT01681030|Primary|Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.|Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closur|Intraoperative, 3 minutes following treatment application||||Participants|||Count of Participants
2649009|NCT01681004|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Any event meeting ISO 14155 definition for serious adverse event at following time points: during procedure (if randomized to iFuse), hospital discharge (if iFuse, typically 1-2 days), and 1, 3, 6, 12, 18 and 24 months after randomization.|Procedure, discharge, 1, 3, 6, 12, 18 and 24 months|All treated study subjects.|||Participants|||Count of Participants
2649010|NCT01681004|Secondary|Work Status|"Non-working subjects who return to work~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|24 Months|Patients not working at baseline due to back or other pain|||Participants|||Count of Participants
2649011|NCT01681004|Secondary|Work Status|"Non-working subjects who return to work~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|18 Months|Patients not working at baseline due to back or other pain|||Participants|||Count of Participants
2649012|NCT01681004|Secondary|Work Status|"Non-working subjects who return to work~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|12 Months|Patients not working at baseline due to back or other pain|||Participants|||Count of Participants
2649013|NCT01681004|Secondary|Work Status|"Non-working subjects who return to work~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|6 Months|Patients not working at baseline due to back or other pain|||Participants|||Count of Participants
2649014|NCT01681004|Secondary|Work Status|"Non-working subjects (due to back pain or other reasons) who return to work~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|3 Months|Patients not working at baseline due to back or other pain|||Participants|||Count of Participants
2649015|NCT01681004|Secondary|Work Status|"Proportion of non-working (due to back pain or other reasons) subjects who return to work~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|1 month|Patients not working at baseline due to back or other pain. Note this is a subset of the entire population.|||Participants|||Count of Participants
2649016|NCT01681004|Secondary|Ambulatory Status|"Time to full ambulation among those without full ambulation at baseline.~60 days was the median of time to full ambulation for the iFuse implant System arm."|24 months (surgical group), 6 months (non-surgical group)|Number of days to full ambulation among those without full ambulation at baseline. At baseline only 13 in the surgical arm were not Ambulatory without assistance and for the NSM group, it was only 5 at baseline.|||Days, median||95% Confidence Interval|Median
2649017|NCT01681004|Secondary|Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits|"Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|24 months|13 iFuse subjects did not complete the 24-month assessment. Analysis was not done for the NSM group at 24 months due to the high crossover rate.|||units on a scale||Standard Deviation|Mean
2649018|NCT01681004|Secondary|Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits|"Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|12 Months|2 iFuse subjects did not complete the survey at month 12. Due to high crossover rate to surgery, analysis in the NSM group is not valid.|||units on a scale||Standard Deviation|Mean
2649019|NCT01681004|Secondary|Improvement in Quality of Life (QOL) as Measured by EQ-5D (EuroQol-5D) at Post-operative Visits|"Improvement in quality of life (QOL) as measured by EQ-5D (EuroQol-5D) at post-operative visits. EQ-5D is a five-question broad quality of life measure that can be combined into a single index and represents the time trade-off (TTO) utility of current health. A score of 0 would = worst imaginable health, while a score of 1.0 would be best imaginable health.~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|6 months|Results show improvement in score from baseline.|||units on a scale||Standard Deviation|Mean
2649020|NCT01681004|Secondary|Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits|"Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that normal scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|24 months|Change in QOL score at 24 months. 89 participants had QOL information at 24 months. Analysis of the NSM cohort is not done because high crossover to surgery prevents valid analysis.|||units on a scale||Standard Deviation|Mean
2649301|NCT01678313|Primary|Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level|"Efficacy:~Change from Baseline in the serum PSA level from baseline and 3 months Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment||||ng/mL||Standard Deviation|Mean
2649021|NCT01681004|Secondary|Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits|"Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that normal scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|12 Months|A total of 2 iFuse subjects had exited the study before making it to their 12 month visit. This outcome is not evaluated in the NSM group at month 12 because high crossover to surgical treatment prevents valid analysis.|||units on a scale||Standard Deviation|Mean
2649022|NCT01681004|Secondary|Improvement in Quality of Life (QOL) as Measured by SF-36 PCS (Physical Component) at Post-operative Visits|"Improvement in quality of life (QOL) as measured by SF-36 PCS (Physical Component) at post-operative / NSM visits. The Short Form 36 health survey (SF-36) is a 36-item patient reported health questionnaire to measure quality of life across 8 domains. The PCS is the Physical Component Summary score. PCS is normed, so that normal scores are 50 +- 10. Higher scores indicate higher quality of life; lower scores indicate lower quality of life. SF-36 PCS (NBS, 2009 norms) ranges from 5 (minimum value, poor physical function) to 80 (maximum, excellent clinical function).~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|6 months|2 iFuse and 2 NSM subjects did not complete SF-36 at month 6.|||units on a scale||Standard Deviation|Mean
2649023|NCT01681004|Secondary|Improvement in Back Dysfunction|Improvement in ODI score of greater than or equal to 15 points compared to baseline. Oswestry Disability Index is a validated measure of disability related to low back pain. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.|24 Months|The Count of participants = number of subjects that had a threshold change in ODI score of greater than or equal to 15 points. Overall number of participants = number of subjects analyzed. Of the 102, a total of 13 iFuse Implant subjects exited the study and 1 did not complete the ODI survey. By 6 months, 39 NSM subjects crossed over to surgical.|||Participants|||Count of Participants
2649024|NCT01681004|Secondary|Improvement in Back Dysfunction|Improvement in ODI score of greater than or equal to 15 points compared to baseline. Oswestry Disability Index is a validated measure of disability related to low back pain. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.|12 Months|2 iFuse subjects did not complete ODI at month 12. ODI analysis is not valid in NSM group at 12 months because of high crossover.|||Participants|||Count of Participants
2649025|NCT01681004|Secondary|Improvement in Back Dysfunction|"Improvement in ODI score of greater than or equal to 15 points, at post-operative visits. 6 month visit.~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|6 Months|1 iFuse and 2 NSM subjects did not complete ODI at month 6.|||Participants|||Count of Participants
2649026|NCT01681004|Secondary|Improvement in Back Dysfunction|"Improvement in ODI score of greater than or equal to 15 points, at month 3.~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|3 Months|2 iFuse subjects and 3 NSM subjects did not complete ODI at month 3.|||Participants|||Count of Participants
2649027|NCT01681004|Secondary|Improvement in Back Dysfunction|"Improvement in ODI score of greater than or equal to 15 points, at month 1.~Oswestry Disability Index is a validated measure of disability related to low back pain. There are 10 sections, each with a score between 0-5. Scores are expressed on a percent basis without using the percent term. Scores range from 0 (no disability) to 100 (completely disabled).~Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol."|1 month|2 iFuse and 1 NSM subjects did not complete ODI at 1 month|||Participants|||Count of Participants
2649028|NCT01681004|Secondary|Improvement in SI Joint Pain VAS Score at 24 Months|Improvement in SI joint pain VAS score of greater than or equal to 20 points compared to baseline. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.|24 Months|12 iFuse subjects did not complete the 24-month pain score. Analysis of 24-month scores in the NSM group is not valid because of the high crossover rate.|||Participants|||Count of Participants
2649029|NCT01681004|Secondary|Improvement in SI Joint Pain VAS Score at 12 Months|Improvement in SI joint pain VAS score of greater than or equal to 20 points compared to baseline. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. Subjects in the NSM group who crossed over are considered failures for this endpoint by definition.|12 Months|2 iFuse subjects did not complete the 12-month pain score. Analysis of 12-month scores in the NSM group is not valid because of the high crossover rate.|||Participants|||Count of Participants
2649030|NCT01681004|Secondary|Improvement in SI Joint Pain VAS Score at 6 Months|Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative & NSM visits after 6 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.|6 Months|1 iFuse and 3 NSM subjects did not complete the 6-month pain score.|||Participants|||Count of Participants
2649031|NCT01681004|Secondary|Improvement in Si Joint Pain VAS Score at 3 Months|Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative & NSM visits after 3 months. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.|3 Months|2 iFuse and 3 NSM subjects did not complete the 3-month pain score.|||Participants|||Count of Participants
2657183|NCT01607853|Secondary|Change From Baseline in Scaling at Day 15|Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 15||||units on a scale||Standard Deviation|Mean
2649032|NCT01681004|Secondary|Improvement in SI Joint Pain VAS Score at 1 Month|Improvement in SI joint pain VAS score of greater than or equal to 20 points, at post-operative & NSM visit after 1 month. The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain. Note that secondary endpoint analysis is based on available data only. No imputation of missing scores was prespecified in the protocol.|1 month|2 iFuse and 1 NSM subjects did not complete the pain score.|||Participants|||Count of Participants
2649033|NCT01681004|Primary|Subject Success|Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention. Note that the primary endpoint analysis is **intent to treat**, meaning that an outcome (success or failure) is assigned to all subjects randomized and treated. Subjects who withdrew early were deemed study failures.|6 months|A modified intent-to-treat approach was used.|||Participants|||Count of Participants
2649034|NCT01680991|Secondary|Time to Recovery of CD19+ B-cell|Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L. Time to recovery is defined as time between the beginning of depletion and first value after end of treatment that is equal or above 0.07x10^9/L and not exclusively followed by depleted values only. If participant did not return to above recovery level then set to Null.|Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year|"Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome and n represents the number of participants evaluable for the specified category."|||days||Standard Deviation|Mean
2649035|NCT01680991|Secondary|Duration of Depletion of CD19+ B-cell|Depletion is defined as CD19+ B-cell count < 0.07 x 10^9/L. The duration of depletion is defined as the number of days between first assessment of B-cell depletion and the first assessment where CD19+ cell count returned to at least the depletion level from baseline and not followed by any further B-cell depletion. If participant did not return to above depletion level, then the cut off is at the time of last assessment.|Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year|Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||days||Standard Deviation|Mean
2649036|NCT01680991|Secondary|Number of Participants With B-cell Depletion or Recovery|Depletion is defined as cluster of differentiation (CD) 19+ B-cell count <0.07 x10^9/L.Recovery is defined as CD19+ B-cell equal to or greater than 0.07 x 10^9/L.|Screening, Cycle 1 (Days 1,8), Cycle 2 (Day 1), Cycle 4 (Day 1), Cycle 6 (Day 1), Cycle 8 (Day 1), 4 weeks after last dose of study drug and every 3 months after last dose of study drug up to 1 year|Safety analysis population.|||participants|||Number
2649037|NCT01680991|Secondary|Number of Participants With Positive Human Anti-Chimeric Antibodies (HACA)|Serum concentrations of HACA against rituximab were determined by ELISA. The LLOQ in undiluted serum was 5.00 relative units per milliliter (RU/mL). The precision and accuracy of the assay, as determined from the analysis of quality control samples, were satisfactory throughout the study; precision ranged from 6.4% to 13.6% and accuracy ranged from 88.2% to 94.8%.|Cycle 1, Day 1|Safety analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||participants|||Number
2649038|NCT01680991|Secondary|Number of Participants With Positive Human Anti-Human Antibodies (HAHA)|For the detection of HAHA, serum samples were initially analyzed using a validated enzyme linked immunosorbent assay (ELISA) method (screening assay, tier 1). The lower limit of quantification (LLOQ) in undiluted serum was 18.4 nanograms per milliliter (ng/mL). The precision ranged from 4.85 percent (%) to 16.0%. In serum samples found positive, the presence of specific anti-obinutuzumab antibodies was confirmed or excluded using the same ELISA method with an appropriate immunocompetition step (addition of excess obinutuzumab, confirmation assay, tier 2). Samples were confirmed as containing specific anti-obinutuzumab antibodies if there was a signal reduction ≥85.7% in the presence of obinutuzumab.|Cycle 1 (Day 1), Cycle 4 (Day 1), 4-week follow-up, 3 and 6 month follow-up|"Safety analysis population. n represents the number of participants who were evaluable at the specified time point."|||participants|||Number
2649039|NCT01680991|Secondary|Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in CLL Participants According to IWCLL 2008 Guidelines|Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of ELN detected BT, b)Red in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb >11 g/dL or ≥50% Inc over baseline, c)Neu > 1500/µL or > 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.|From screening to up to 2 months after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for CLL participants.|||percentage of participants||95% Confidence Interval|Number
2649040|NCT01680991|Secondary|Percentage of Participants With BOR of CRe, CRi at Anytime During the Study in CLL Participants According to IWCLL 2008 Guidelines|CRe required the following criteria as assessed, at least 2 months from completing therapy: a) PBL <4 x 10^9/L, b) Absence of significant LD by PE, c) No HM/SM by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neu >1.5 x 10^9/L without the need for EGF, ii. Plt >100 x 10^9/L without the need for EGF, and iii. Hb >11.0 g/dL without blood transfusion or need for EGF, and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, <30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.|From screening to up to 2 months after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for CLL participants.|||percentage of participants||95% Confidence Interval|Number
2649041|NCT01680991|Secondary|Percentage of Participants With PR, SD, and PD at End of Treatment (1 Month After Cycle 8) in CLL Participants According to IWCLL 2008 Guidelines|Group A: a)Dec LN size by ≥50% either in SPD of 6 LN or largest diameter of enlarged LN (ELN) detected BT, b)Reduction (Red) in BT enlargement of liver, c)Red in BT enlargement of spleen, d)Dec in PBL by ≥50% from baseline, e)A 50% Red in BM infiltrate or B-lymphoid nodules in BM and f)No Inc in any LN and no new ELN. Group B: a)Plt count=100,000/µL or Inc of ≥50% over baseline, b)Hb >11 g/dL or ≥50% Inc over baseline, c)Neu > 1500/µL or > 50% Inc over baseline. PR is considered as achieved if 2 of Group A criteria and 1 of Group B criteria were met for ≥2 months. PD is defined as LD (appearance of new lesion [ELN], SM, HM or other organ infiltrates) or Inc by ≥50% in greatest determined diameter of any previous site or Inc in previously noted enlargement of liver/spleen by ≥50% or new appearance of HM/SM or an Inc in number of PBL ≥50% or transformation to a more aggressive histology or occurrence of cytopenia attributable to CLL. SD is defined as less than a PR but is not PD.|2 months after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for CLL participants|||percentage of participants||95% Confidence Interval|Number
2649042|NCT01680991|Secondary|Percentage of Participants With Complete Remission (CRe), CRe With Incomplete BM Recovery (CRi) at End of Treatment (1 Month After Cycle 8) in CLL Participants According to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Guidelines|CRe required the following criteria as assessed, at least 2 months from completing therapy: a) peripheral blood lymphocytes (PBL) less than (<) 4 x 10^9/L, b) Absence of significant lymphadenopathy (LD) by physical examination (PE), c) No hepatomegaly/splenomegaly (HM/SM) by PE, d) Absence of constitutional symptoms and e) Blood counts above the following values (i. Neutrophils [Neu] >1.5 x 10^9/L without the need for exogenous growth factors [EGF], ii. Platelets (Plt) >100 x 10^9/L without the need for EGF, and iii. Hemoglobin (Hb) >11.0 g/dL without blood transfusion or need for erythropoietin), and d) Once clinical and laboratory reports demonstrated CRe, a BM aspirate and biopsy was performed at least 2 months after the last treatment; to define a CRe, BM sample should be normocellular for age, <30% of the cells being PBL and lymphoid nodules absent. CRi: CRe but persistent anemia/thrombocytopenia/neutropenia unrelated to CLL, but related to drug toxicity.|2 months after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for CLL participants.|||percentage of participants||95% Confidence Interval|Number
2649043|NCT01680991|Secondary|Percentage of Participants With BOR of PR, SD, and PD at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria|PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.|From screening to up to 1 month after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for DLBCL and FL arm groups.|||percentage of participants||95% Confidence Interval|Number
2649044|NCT01680991|Secondary|Percentage of Participants With Best Overall Response (BOR) of CR, CRu at Anytime During Study in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria|CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) LN and nodal masses regressed to normal size AT (≤1.5 cm] in their GTD for LN >1.5 cm BT). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or >75% in the SPD of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules in any organs, 5) Enlarged organs decreased in size, and 6) If the BM was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass >1.5 cm in GTD that has regressed by more than 75% in their SPD, b) Indeterminate BM (increased number or size of aggregates).|From screening to up to 1 month after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for DLBCL and FL arm groups.|||percentage of participants||95% Confidence Interval|Number
2649045|NCT01680991|Secondary|Percentage of Participants With Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria|PR: 1) ≥50% decrease in SPD of the 6 largest dominant nodes/nodal masses. These nodes or masses selected according to the following features: a) clearly measurable in ≥2 perpendicular dimensions, b) from as disparate regions of the body as possible, and c) included mediastinal and retroperitoneal areas of disease. 2) No increase in size of other nodes (liver/spleen). 3) Splenic and hepatic nodules regressed by ≥50% in SPD. 4) With exception of splenic and hepatic nodules, involvement of other organs was considered assessable and not measurable disease. 5) BM assessment is irrelevant for determination of a PR because it was assessable and not measurable disease; however, if positive, the cell type was specified. 6) No new sites of disease. PD requires the following: 1) ≥50% increase from nadir in the SPD of any previously identified abnormal node for PRs or nonresponders. 2) Appearance of any new lesion during or at the end of therapy. SD is defined as less than a PR but not PD.|1 month after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for DLBCL and FL arm groups.|||percentage of participants||95% Confidence Interval|Number
2649060|NCT01680900|Secondary|Menopause-related Quality of Life (MENQOL)|The MENQOL is a validated measure to assess the presence and bother of menopausal symptoms. This will be exploratory. Each of 29 items is rated on a scale of 0 to 6 (extremely bothersome). The items are divided into 4 subscales. The item scores are summed in each subscale and means are computed for the 4 subscales. The total score is the sum of the mean subscale scores. Higher scores are more symptomatic.|Week 8||||units on a scale||95% Confidence Interval|Mean
2649061|NCT01680900|Secondary|Percent of Patients With >=50% Reduction in Moderate to Severe Hot Flashes|Percent of patients with n >=50% reduction in frequency of moderate to severe hot flashes calculated from daily diaries|Percent change from baseline at Week 8|all participants with at least one treatment response|||percentage of participants|||Number
2649046|NCT01680991|Secondary|Percentage of Participants With Complete Response (CR), CR Unconfirmed (CRu) at End of Treatment (1 Month After Cycle 8) in NHL Participants (DLBCL and FL Participants) Per Cheson 1999 Criteria|CR: 1) Disappearance of clinical and radiographic evidence of disease, related symptoms and normalization of biochemical abnormalities definitely assignable to NHL, 2) Lymph nodes (LN) and nodal masses regressed to normal size after therapy (AT) (≤1.5 centimeters [cm] in their greatest transverse diameter [GTD] for LN greater than (>) 1.5 cm before therapy [BT]). LN that were 1.1 to 1.5 cm in their GTD BT decreased to ≤1 cm in GTD AT, or >75% in the sum of the products (SPD) of the GTD, 3) Enlarged spleen regressed in size and not palpable, 4) Absence of macroscopic nodules, 5) Enlarged organs decreased in size, and 6) If the bone marrow (BM) was involved, the infiltrate must be cleared on repeat BM aspirate and biopsy. CRu included those participants who met CR Criteria 1 and 3, but with 1 or more of the following features: a) A residual LN mass >1.5 cm in GTD that has regressed by more than 75% in their SPD, and b) Indeterminate BM (increased [Inc] number or size of aggregates).|1 month after the last dose (received on Day 148) of study drug|Safety analysis population. Data reported only for DLBCL and FL arm groups.|||percentage of participants||95% Confidence Interval|Number
2649047|NCT01680991|Secondary|Minimum Observed Serum Concentration of Obinutuzumab||Within 2 hours Pr-D on Day 1 of Cycles 2-8 and on Days 8,15 of Cycle 1|"PK population. Here, number of participants analyzed = participants who were evaluable for this outcome and n is the number of participants evaluable at the specified time point."|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2649048|NCT01680991|Secondary|Total Systemic Clearance at Steady State (CLss) of Obinutuzumab at Cycle 8|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||mL/day||Geometric Coefficient of Variation|Geometric Mean
2649049|NCT01680991|Secondary|Volume of Distribution at Steady State (Vss) of Obinutuzumab at Cycle 8|Vss reflects the actual blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces.|Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||Liter||Geometric Coefficient of Variation|Geometric Mean
2649050|NCT01680991|Secondary|Apparent Terminal Half-life (t1/2)|Half-life is the time measured for the serum concentration of study drug to decrease (Dec) by one half.|Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1, 4-week follow-up (Day 29), 3 and 6 months after Cycle 8 dosing|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||day||Geometric Coefficient of Variation|Geometric Mean
2649051|NCT01680991|Secondary|Time to Maximum Observed Serum Concentration (Tmax) of Obinutuzumab at Cycle 8||Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||hours||Full Range|Median
2649052|NCT01680991|Primary|Cmax of Obinutuzumab at Cycle 8||Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2649053|NCT01680991|Primary|Area Under the Serum Concentration Versus Time Curve From 0 to Day 21 (AUC0-21) of Obinutuzumab at Cycle 8||Cycle 8: within 2 h Pr-D, EoI, 4, 24, 72, 120, 168, 336 (Day 15), and 504 (Day 22) h Po-I on Day 1|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||day*mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2649054|NCT01680991|Primary|Maximum Observed Serum Concentration (Cmax) of Obinutuzumab on Day 1, Cycle 1|DLBCL and FL are sub-types of NHL and time frame for these 2 groups was presented under NHL. For CLL, PK parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.|Cycle 1-NHL: within 2 h Pr-D, EoI, 4, 24, 72 and 120 h Po-I on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8|PK analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.|||micrograms per milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2649055|NCT01680991|Primary|Area Under the Serum Concentration Time Curve From Zero to Day 7 (AUC0-7) of Obinutuzumab on Day 1, Cycle 1|DLBCL and FL are sub-types of Non-Hodgkin's Lymphoma (NHL) and time frame for these 2 groups was presented under NHL. For CLL, pharmacokinetic (PK) parameters were from Cycle 1 Day 1 and Day 2 dosing, due to split dosing.|Cycle 1-NHL: within 2 hours (h) pre-dose (Pr-D), end of infusion (EoI), 4, 24, 72 and 120 h post-infusion (Po-I) on Day 1; CLL: within 2 h Pr-D, EoI on Days 1,2; 4, 24, 72 and 120 h Po-I on Day 2. NHL and CLL: within 2 h Pr-D on Day 8|PK analysis population included all participants who received at least 1 dose of study drug and had serum concentrations available. Here, number of participants analyzed = participants who were evaluable for this outcome.|||day*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2649056|NCT01680900|Primary|Daily Diary Ratings of Severity of Hot Flashes|Hot flash severity will be recorded daily in the am and pm on a scale of 0 (none) to 3 (severe). The frequency of hot flashes was the number reported. The severity of hot flashes was rated on a scale of 0 (none) to 3 (severe). 7-day averages were calculated for baseline, week 4 and week 8 and a mean daily score was obtained for analysis. Baseline values were the means of the first 2 screen weeks. Possible range of the severity scale for the daily mean was 0 (none) to 3 (severe).|Week 8.|all participants randomized to treatment|||units on a scale||95% Confidence Interval|Mean
2649057|NCT01680900|Other Pre-specified|Sheehan Global Ratings of Symptom (Hot Flash)Interference|Global ratings on a 10-point scale of the degree that symptoms interfere overall, with work, social activities and family life.|Change from Baseline at Week 8|||||||
2649058|NCT01680900|Other Pre-specified|Percentage of Participants That Were Satisfied or Very Satisfied|Patient global rating of satisfaction with medication reported on a scale of 0 to 5 (very satisfied).|Week 8|all participants with at least one treatment response.|||percentage of participants|||Number
2649059|NCT01680900|Other Pre-specified|Number of Participants With Adverse Events|A 17 item checklist of general adverse and withdrawal symptoms. It will be used at baseline and Week 12. Adverse events will be obtained by subject report at Week 4 and Week 8.|Baseline and Week 12||||participants|||Number
2649062|NCT01680900|Primary|Daily Diary Ratings of Frequency of Hot Flashes|Hot flash frequency and severity will be recorded daily in the am and pm on a scale of 0 (none) to 3 (severe). The frequency of hot flashes was the number reported.|Week 8.|all participants randomized to treatment|||number of hot flashes||95% Confidence Interval|Mean
2649063|NCT01680887|Secondary|Average Weekly Cocaine Craving Scores Varenicline Group Versus the Placebo Group Comparator|As measured by average weekly scores for cocaine craving on the brief substance craving scale combining cocaine craving frequency, intensity and duration. Minimum value 0 maximum value 12 higher scores indicate worse craving.|Once per week in weeks 2 through 13||||score on a scale||Standard Deviation|Mean
2649064|NCT01680887|Primary|Number of Participants Who Report no Cocaine Use and Have no Cocaine Positive Urine Drug Screens in the Chantix Group Versus the Placebo Group Comparator During the Last Three Weeks of the Trial|Number of subjects with cocaine abstinence as measured through three-times-weekly urine benzoylecgonine (BE) levels in urine drug screen (UDS) and self-reports of use from the Time Line Follow Back. UDS results and TLFB reports combined to yield weekly use/no-use indicators for each week of treatment.|weeks 11,12,13 of the trial|all subject|||Participants|||Count of Participants
2649065|NCT01680861|Secondary|Discontinuance of Any Study Medication (Tacrolimus, Everolimus, or EC-MPS)||during the first 12 months post-transplant|Note: one patient in the Tacrolimus/EC-MPS arm discontinued EC-MPS at 12 months post-transplant following a colon cancer diagnosis and the necessity to receive chemotherapy.|||participants|||Number
2649066|NCT01680861|Secondary|eGFR (Renal Function) at 6 Months Post-transplant|using the abbreviated MDRD formula.|at 6 months post-transplant||||ml/min per 1.73 m2||Standard Error|Mean
2649067|NCT01680861|Secondary|eGFR (Renal Function) at Month 3 Post-transplant|Renal function as determined by the estimated glomerular filtration rate (eGFR) at 3 months post-transplant, using the abbreviated MDRD formula.|at 3 months post-transplant||||ml/min per 1.73 m^2||Standard Error|Mean
2649068|NCT01680861|Secondary|eGFR (Calculated Glomerular Filtration Rate), i.e., Renal Function, at 1 Month Post-transplant.|using the abbreviated MDRD formula.|at 1 month post-transplant||||ml/min per 1.73 m2||Standard Error|Mean
2649069|NCT01680861|Secondary|Graft Loss (Return to Permanent Dialysis or Death)||during the first 12 months post-transplant||||participants|||Number
2649070|NCT01680861|Secondary|Incidence of Chronic Allograft Nephropathy (CAI) at 12 Months Post-transplant|Incidence of (biopsy-proven) chronic allograft nephropathy (CAI) [interstitial fibrosis and tubular atrophy, using standard Banff criteria] at 12 months post-transplant.|1 year||||participants|||Number
2649071|NCT01680861|Primary|BPAR (Biopsy-proven Acute Rejection) Incidence During the First 12 Months Post-transplant|BPAR (biopsy-proven acute rejection) incidence during the first 12 months post-transplant. Grading is determined using standard Banff criteria.|1 year||||participants|||Number
2649072|NCT01680848|Primary|Percentage of Participants Who Indicate Surgical Intervention||Up to 24 months||||percentage of the dentists|||Number
2649073|NCT01680835|Secondary|Secondary Outcome - Number of Adverse Events|Number of Adverse Events in the study through 3 Years.|3 Years||||Adverse Events|||Number
2649074|NCT01680835|Secondary|Secondary Outcome - Change in Score of Walking Impairment Questionnaire at 1 Year|"Defined as an increase in Walking Impairment Questionnaire score in subjects who did not have iliac disease treated at the time of the index procedure compared to baseline~Scale Range: Minimum score 0 to maximum score 100 Higher values represent better outcomes"|1 Year|The total number of participants in the study was 108; number of participants analyzed depends on the questionnaires completed|||score on a scale||Standard Deviation|Mean
2649075|NCT01680835|Secondary|Secondary Outcome - Number of Participants With Improvement in Ankle-Brachial Index at 1 Year|Defined as an increase in the ankle-brachial index (ABI) compared to baseline in subjects with compressible arteries and baseline ABI < 0.9.|1 Year|There were 71 participants that were evaluated for the Ankle-Brachial Index at 1 Year|||Participants|||Count of Participants
2649076|NCT01680835|Secondary|Secondary Outcome - Number of Participants With Improvement in Rutherford Clinical Category at 1 Year|Defined as an improvement in clinical status indicated by a decrease of one or more in Rutherford Clinical Category compared to baseline.|1 Year|There were 95 participants that were evaluated for the Rutherford Clinical Category at 1 Year|||Participants|||Count of Participants
2649077|NCT01680835|Secondary|Secondary Outcome - Number of Successfully Implanted Stents|Defined as the ability to deploy the stent as intended at the treatment site.|At procedure||||Implanted Stents|Implanted Stents||Count of Units
2649078|NCT01680835|Secondary|Secondary Outcome - Number of Participants Free From Acute Death|Defined as the absence of all-cause mortality occurring within 30 days of the procedure.|30 days||||Participants|||Count of Participants
2649079|NCT01680835|Secondary|Secondary Outcome - Freedom From 36-month Clinically-driven Target Lesion Revascularization|Defined as the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 36 months of the procedure.|3 Years||||participants|||Number
2649080|NCT01680835|Secondary|Secondary Outcome - Freedom From 36-month Amputation|Defined as the absence of any major amputation (removal of the target limb or a part of the target limb above the metatarsal line) within 36 months of the procedure.|3 Years||||participants|||Number
2649081|NCT01680835|Secondary|Secondary Outcome - Freedom From Acute Death, Freedom From Amputation and Freedom From Clinically-driven Target Lesion Revascularization at 1 and 2 Years|Defined as the absence of all-cause mortality occurring within 30-days, absence of any major amputation within 12-/24- months and the absence of any clinically-driven repeat invasive procedure, including angioplasty, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen diameter inside or within 10 mm of the previously treated lesion due to the return of clinical symptoms within 12-/24- months of the procedure.|1 and 2 years||||participants|||Number
2649107|NCT01680497|Secondary|Subject Satisfaction With Aesthetic Outcome on an 11-Point Scale|Subject satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).|Day 14, Month 1, Month 9, Month 12|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point|||Scores on a Scale||Standard Deviation|Mean
2649082|NCT01680835|Secondary|Secondary Outcome - Freedom From Stent Fracture|"Determined by x-ray at 1, 2 and 3 years using the following classifications:~Class 0 - No strut fractures Class I - Single tine fracture Class II - Multiple tine fractures Class III - Stent fracture(s) with preserved alignment of the components Class IV - Stent fracture(s) with mal-alignment of the components Class V - Stent fracture(s) in a trans-axial spiral configuration~AND the following categories:~Category A - Restenosis ≤ 50% at site of fracture Category B - Restenosis ≥ 50% at site of fracture Category C - Occlusion at site of fracture Category D - Unable to determine"|1, 2 and 3 years|There were 103 stents evaluated by the Stent Fracture Adjudication Committee.|||Stent|||Number
2649083|NCT01680835|Primary|Primary Outcome - Freedom From Acute Death, Freedom From 36-month Amputation, and Freedom From 36-month Clinically-driven Target Lesion Revascularization|Composite endpoint defined as freedom from acute death, freedom from 36-month amputation, and freedom from 36-month clinically-driven target lesion revascularization compared to a PTA performance goal.|3 Years|Subjects experiencing primary outcome within 3 years.|||Participants|||Count of Participants
2649084|NCT01680783|Other Pre-specified|Improvement of Oxygenation|Improvement of oxygenation-defined as PaO2/FiO2 ≥ 200 or increase from baseline by 100|2 weeks|||||||
2649085|NCT01680783|Other Pre-specified|Discharge Location|Measure the location (ie home, rehabilitation center, nursing home) that patients are discharged to|6 weeks|||||||
2649086|NCT01680783|Other Pre-specified|Readmission to the Intensive Care Unit|Measure the need for readmission to the intensive care unit during initial hospitalization at time of enrollment|6 weeks|||||||
2649087|NCT01680783|Other Pre-specified|ICU Complications|ICU complications will include rates of Ventilator associated pneumonia, Barotrauma, Gastrointestinal hemorrhage, Pulmonary embolism, Sacral Decubitus ulcer, Delirium, ICU acquired weakness|6 weeks|||||||
2649088|NCT01680783|Secondary|Intensive Care Unit Length of Stay|Number of days admitted to a medical intensive care unit|4 weeks||2018-06-30|06/2018||||
2649089|NCT01680783|Secondary|Hospital Mortality|Death from any cause during hospitalization at time of enrollment|6 weeks||2018-06-30|06/2018||||
2649090|NCT01680783|Secondary|Ventilator Days|Duration of mechanical ventilation via endotracheal tube|number of days in the hospital||2018-06-30|06/2018||||
2649091|NCT01680783|Secondary|Functional Status After Discharge|Telephone survey of patients 1, 6, and 12 months after discharge to assess need for re-hospitalization, admission to nursing home, and functional status (ability to complete ADLs and IADLs independently)|Measured at 1, 6, and 12 months after hospital discharge (to span time frame of up to 80 weeks depending on length of hospitalization)||2018-06-30|06/2018||||
2649092|NCT01680783|Secondary|Hospital Length of Stay|Days spent in hospital at time of enrollment|Duration of hospital stay||2018-06-30|06/2018||||
2649093|NCT01680783|Primary|Need for Endotracheal Intubation|Number of patients requiring endotracheal intubation after application of helmet device|6 weeks||||Participants|||Count of Participants
2649094|NCT01680666|Secondary|Time to Successful Cannulation||Up to 410 seconds||||seconds||Full Range|Mean
2649095|NCT01680666|Secondary|Patients With Complications|The count (%) of patients with complications (including hemothorax, hematoma, pneumothorax, or catheter malposition) is presented.|Up to 410 seconds||||Participants|||Count of Participants
2649096|NCT01680666|Secondary|Patients With Arterial Punctures|The count (%) of patients with arterial punctures is presented.|Up to 410 seconds||||Participants|||Count of Participants
2649097|NCT01680666|Secondary|Success of Central Venous Cannulation Within First Three Attempts|The count (%) of patients with successful central venous cannulation within the first three attempts is reported.|Up to 410 seconds||||Participants|||Count of Participants
2649098|NCT01680666|Primary|Success of Central Venous Cannulation at First Attempt|The count (%) of patients with successful central venous cannulation at first attempt is reported.|Up to 410 seconds||||Participants|||Count of Participants
2649099|NCT01680653|Other Pre-specified|Prolonged Episodes of Hypoglycemic Events|Prolonged hypoglycemia is defined as glucose readings of either <70 mg/dL for greater than one hour on and off the device, <70 mg/dL for greater than 2 hours on and off the device, <50 mg/dL that lasted longer than 30 minutes on and off the device and readings of <50 mg/dL for longer than an hour, again for both the control and the subjects that were remotely monitored with the device. Each camper had Remote Monitoring nights and Control nights.|8 hours at night||||events|||Number
2649100|NCT01680653|Secondary|Duration of Glucose Readings <70 mg/dl|Number of minutes with glucose reading < 70 mg/dL. Each camper had Remote Monitoring nights and Control nights.|8 Hours||||minutes|Hypoglycemic events|Inter-Quartile Range|Median
2649101|NCT01680653|Primary|Duration of Nocturnal Hypoglycemia|Number of minutes with glucose reading < 50 mg/dL. Each camper had Remote Monitoring nights and Control nights.|8 hours||||minutes|Hypoglycemic events|Inter-Quartile Range|Median
2649102|NCT01680549|Secondary|Patient Restfulness|Percentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2.|3 days||||Percent(%) of participants|||Number
2649103|NCT01680549|Secondary|Knee Range of Motion|Patient knee range of motion was assessed on postoperative days 0, 1 and 2.|3 days||||Degrees||Standard Deviation|Mean
2649104|NCT01680549|Secondary|Narcotics Consumption|Narcotics consumption was recorded on postoperative days 0, 1, and 2.|3 days||||Morphine dose equivalents||Standard Deviation|Mean
2649105|NCT01680549|Primary|Patient Pain Scores|"Patient's pain assessed by the Visual Analog Scale (VAS - Units on a scale) on postoperative days 0, 1 and 2.~Scale range: 0-100 Higher Values = More Pain"|3 days||||units on a scale- VAS||Standard Deviation|Mean
2649106|NCT01680497|Secondary|Subject Assessments of Pain, Swelling, and Bruising Intensity on an 11-Point Scale|Subject assessment of pain, swelling and bruising intensity on an 11-point scale. Scores range from 0 (No pain/swelling/bruising) to 10 (worst pain/swelling/bruising imaginable).|Day 0, Day 14, Month 12, Month 12.5|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point|||Scores on a Scale||Standard Deviation|Mean
2649172|NCT01679197|Secondary|Fasting Glucose||1 year|The number of participants analyzed at month 12 differs from the overall number analyzed at baseline because 4 participants dropped from the study before their month 12 visit.|||mg/dL||Standard Deviation|Mean
2649108|NCT01680497|Secondary|Subject Assessment of Nasolabial Fold Severity Using the 5-point NLFSS|Nasolabial fold severity is evaluated by the subject on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).|Day 0, Day 14, Month 1, Month 9, Month 12|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point|||Scores on a Scale||Standard Deviation|Mean
2649109|NCT01680497|Secondary|Investigator Assessment of Ease of Injection Use on a 10-Point Scale|Investigator assessment of ease of injection use is assessed on a 10-point scale. Scores range from 0 (easy) to 10 (hard).|Day 0, Day 14|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point|||Scores on a Scale||Standard Deviation|Mean
2649110|NCT01680497|Secondary|Investigator Satisfaction With Aesthetic Outcome on an 11-Point Scale|Investigator satisfaction with aesthetic outcome is assessed on an 11-point scale. Scores range from -5 (definitely not satisfied), 0 (don't know/unsure), and 5 (definitely satisfied).|Day 14, Month 1, Month 9, Month 12|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point|||Scores on a Scale||Standard Deviation|Mean
2649111|NCT01680497|Secondary|Investigator Assessment of Nasolabial Fold Severity Using the 5-point NLFSS|Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).|Day 0, Day 14, Month 1, Month 9|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point|||Scores on a Scale||Standard Deviation|Mean
2649112|NCT01680497|Primary|Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS)|Nasolabial fold severity is evaluated by the Investigator on the 5-point NLFSS on both the right and left sides. Scores are assessed as 1 (none), 2 (mild), 3 (moderate), 4 (severe), and 5 (extreme).|Month 12|Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point|||Scores on a Scale||Standard Deviation|Mean
2649113|NCT01680458|Primary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 13 Weeks|SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.|||Participants|||Number
2649114|NCT01680458|Primary|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 13 Weeks|SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.|||Participants|||Number
2649115|NCT01680458|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to fluconazole in a participant who received fluconazole. Relatedness to fluconazole was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 13 Weeks|SAS comprised of participants who had met the inclusion criteria and had received fluconazole at least once.|||Participants|||Number
2649116|NCT01680458|Secondary|Onset Rate of Deep Mycosis|Efficacy of deep mycosis prophylaxis was evaluated by the presence or absence of deep mycosis onset during the observation period. Onset rate of deep mycosis was calculated as follows and presented along with the corresponding exact 2-sided 95% CI. Onset rate of deep mycosis (%) = (Number of participants with deep mycosis onset by target fungi) / (Number of participants available for prophylactic efficacy evaluation) x 100.|MAX 13 Weeks|Efficacy analysis set for prophylaxis comprised of participants in SAS who had started to receive fluconazole for the prophylaxis and had been evaluated for the presence or absence of deep mycosis onset.|||Percentage of participants||95% Confidence Interval|Number
2649117|NCT01680458|Secondary|Fungi Eradication Rate|"Mycological effect of treatment was evaluated as follows: (1) eradicated; the causative fungi detected from the lesion before treatment became undetectable, (2) presumably eradicated; the lesion was improved and sampling of causative fungi became impossible, (3) decreased; the causative fungi were decreased, (4) unchanged; no change was observed in the causative fungi, (5) increased; the causative fungi were increased (including microbial substitution), and (6) indeterminate; the clinical follow-up was inadequate, causative fungi were undetectable, or mycological test was not performed. Fungi eradication rate was calculated as follows. Fungi eradication rate (%) = (Number of participants evaluated as eradicated or presumably eradicated) / (Number of participants available for mycological efficacy evaluation) x 100"|MAX 13 Weeks|Mycological analysis set for treatment comprised of participants in SAS with the final diagnosis of deep mycosis, who had started to receive fluconazole for the treatment and had been evaluated for the mycological effect.|||Percentage of participants|||Number
2649118|NCT01680458|Secondary|Clinical Efficacy Rate|Clinical effect of treatment was evaluated based on the clinical course excluding mycological effect as follows: (1) effective, (2) ineffective, or (3) unevaluable. Clinical efficacy rate was calculated as follows and presented along with the corresponding exact 2-sided 95% CI. Clinical efficacy rate (%) = (Number of responders in evaluation of clinical effect) / (Number of participants available for clinical efficacy evaluation) x 100.|MAX 13 Weeks|Efficacy analysis set for treatment comprised of participants in safety analysis set (SAS) who had started to receive fluconazole for the treatment and had been evaluated for the clinical effect.|||Percentage of participants||95% Confidence Interval|Number
2657184|NCT01607853|Secondary|Change From Baseline in Scaling at Day 11|Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 11||||units on a scale||Standard Deviation|Mean
2649119|NCT01680341|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 am.|Weeks 0-27|The safety analysis set included all subjects who received at least one dose of the investigational product.|||episodes|||Number
2649120|NCT01680341|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes in the Maintenance Period|Confirmed hypoglycaemic episodes in the maintenance period (from Week 16 to the end of the trial including follow-up [Week 27]) consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|From week 16 to end of trial including follow-up (week 27)|The safety analysis set included all subjects who received at least one dose of the investigational product. Subjects in maintenance period were included in this analysis.|||episodes|||Number
2649121|NCT01680341|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes consisted of episodes of severe hypoglycaemia and minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Weeks 0-27|The safety analysis set included all subjects who received at least one dose of the investigational product.|||episodes|||Number
2649122|NCT01680341|Secondary|Incidence of Treatment Emergent Adverse Events (TEAEs)|A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.|Weeks 0-28|The safety analysis set included all subjects who received at least one dose of the investigational product.|||number of events|||Number
2649123|NCT01680341|Secondary|Percentage of Subjects With HbA1c Below 7.0% Without Confirmed Hypoglycaemia|Percentage of subjects with HbA1c below 7% without confirmed hypoglycaemic episodes after 26 weeks of treatment.|Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF. Twenty five (25) subjects did not contribute to statistical analysis as Endpoint was only defined for subjects exposed for at least 12 treatment weeks.|||percentage of subjects|||Number
2649124|NCT01680341|Secondary|Subjects With HbA1c Below 7.0%|Number of subjects with HbA1c below 7% after 26 weeks of treatment.|Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF.|||Subjects|||Number
2649125|NCT01680341|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF.|||mmol/L||Standard Error|Least Squares Mean
2649126|NCT01680341|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF).|||Percent (%) glycosylated haemoglobin||Standard Error|Least Squares Mean
2649127|NCT01680328|Secondary|Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion|Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.|2 minutes (±30sec) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. One subject did not contribute to the analysis due to missing injection.|||mcL||Standard Deviation|Mean
2649128|NCT01680328|Secondary|Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion|Backflow was measured after each injection by placing a filter paper over the injection site after the injection was given and until the liquid was absorbed. The size of the wet spot on the filter paper served as a measure of the backflow. The treatment effect on backflow was calculated as the least square mean estimate of the difference in backflow after injection in the abdomen at different volume and speed combinations.|2 minutes (±30sec) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. One subject did not contribute to the analysis due to missing injection.|||mcL||Standard Deviation|Mean
2649129|NCT01680328|Secondary|Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen.|Acceptance of pain was rated subjectively as yes or no by the subject after each injection.|1 minute (±30 seconds) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set.|||scores|||Number
2649130|NCT01680328|Secondary|Acceptance of Injection Pain After Injection at Different Speeds.|Acceptance of pain was rated subjectively as yes or no by the subject after each injection.|1 minute (±30 sec) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set.|||scores|||Number
2649131|NCT01680328|Secondary|Acceptance of Injection Pain After Injection of Different Volumes.|Acceptance of pain was rated subjectively as yes or no by the subject after each injection.|1 minute (±30 seconds) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set.|||scores|||Number
2649173|NCT01679197|Secondary|Fasting Lipids|Cholesterol, triglycerides, HDL cholesterol, and LDL together make up the lipid profile and must be reported together. We are reporting the lipid profile where the treatment group arm would normally be listed, though, we are looking at the same single arm population of 23 participants who received treatment in this study.|1 year|The number of participants analyzed at month 12 differs from the overall number analyzed at baseline because 4 participants dropped from the study before their month 12 visit.|||mg/dL||Standard Deviation|Mean
2649132|NCT01680328|Primary|Injection Pain (VAS mm)|Calculated as the least square mean estimate of the difference in injection pain on a VAS (mm) between different factor levels corresponding to injection region, injection volume and injection speed (pain was assessed using an electronic VAS consisting of a 100 mm line where 0 mm corresponded to no pain and 100 mm corresponded to worst pain. After each injection, the subjects rated their pain perception at the electronic VAS by marking the 100 mm line).|1 minute (±30 sec) after each injection|All randomised subjects receiving at least one injection (possibly needle insertion only) were included in the full analysis set. A total of 4 subjects did not contribute to the analysis due to missing injections (2) and missing VAS evaluation (2).|||mm||Standard Deviation|Mean
2649133|NCT01680172|Primary|Hospital Anxiety Depression Scale- Depression Score (HADS-D)|Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be >10 for anxiety and >8 for depression.|Baseline, 120 minutes|Study was terminated early due to slow accrual.|||units on a scale||Standard Deviation|Mean
2649134|NCT01680172|Primary|Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A)|Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be >10 for anxiety and >8 for depression.|Baseline, 120 minutes|Study was terminated early due to slow accrual.|||units on a scale||Standard Deviation|Mean
2649135|NCT01680159|Secondary|Assessment of Severity (Only for Patients With Pustular Psoriasis)|From 0 (best) to 17 (worst)|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period||||units on a scale||Full Range|Mean
2649136|NCT01680159|Secondary|Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)|From 0 (best) to 100 (worst)|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period||||mm||Full Range|Median
2649137|NCT01680159|Secondary|Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)|"The investigator or the subinvestigator made a global assessment of skin lesions in terms of the degree of erythema, induration, and scaling (scale), using the following 6-point scale (0 to 5). When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PGA for each patient were performed by the same investigator or subinvestigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator or the subinvestigator changed jobs). Outcome measure data table is reported percentage of participants with Cleared and Minimal skin lesions.~0: Cleared, 1: Minimal, 2: Mild, 3: Moderate, 4: Marked, 5: Severe"|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period||||percentage of participants|||Number
2649138|NCT01680159|Secondary|Psoriasis Area and Severity Index (PASI) Score|Score range is 0-72. Higher values represent a worse outcome. The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were added scores of the each regions.|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period||||units on a scale||Full Range|Median
2649139|NCT01680159|Primary|Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score|"The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling [scale]) at each of the regions and the extent of area affected. Total sores were calculated scores of the each regions.~When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered.~As a rule, the PASI score assessments for each patient were performed by the same investigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator changed jobs).~The number and percentage of patients achieving a 75% improvement in their PASI scores at each assessment time point."|Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period||||percentage of participants|||Number
2649140|NCT01680016|Primary|Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)|The safety of Rabipur was assessed in terms of subjects(Older Adults) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.|from V1/day 1 (postvaccination) through V7/study termination day 43|Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Subjects|||Number
2649141|NCT01680016|Primary|Number of Children Who Reported Unsolicited Adverse Events (AEs)|The safety of Rabipur was assessed in terms of subjects(Children) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.|From V1/day 1 (postvaccination) through V7/study termination day 43|Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Subjects|||Number
2649142|NCT01680016|Secondary|GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults.|Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 42 days after first vaccination (day 43)|For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.|||Concentration (IU/ml)||95% Confidence Interval|Geometric Mean
2649174|NCT01679197|Secondary|Liver Function Tests|AST and ALT are the liver function tests. We are reporting the liver function tests where the treatment group arm would normally be listed, though, we are looking at the same single arm population of 23 participants who received treatment in this study.|1 year|The number of participants analyzed at month 12 differs from the overall number analyzed at baseline because 4 participants dropped from the study before their month 12 visit.|||IU/L||Standard Deviation|Mean
2649143|NCT01680016|Secondary|GMCs of RVNA Titer 42 Days After First Vaccination in Children.|Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 42 days after first vaccination (day 43)|For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.|||Concentration (IU/mL)||95% Confidence Interval|Geometric Mean
2649144|NCT01680016|Primary|Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur|Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Days 1 to 7 postvaccination|Analysis was done on the safety set|||Subjects|||Number
2649145|NCT01680016|Primary|Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur|Safety was assessed as the number of children who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Days 1 to 7 postvaccination|Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Subjects|||Number
2649146|NCT01680016|Secondary|Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur|Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 42 days after first vaccination (day 43).|For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.|||Percentages of subjects||95% Confidence Interval|Number
2649147|NCT01680016|Secondary|Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur|Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 42 days after first vaccination (day 43).|For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.|||Percentages of subjects||95% Confidence Interval|Number
2649148|NCT01680016|Secondary|Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur|Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 14 days after first vaccination (day 15).|For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.|||Percentages of subjects||95% Confidence Interval|Number
2649149|NCT01680016|Secondary|Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur|Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 14 days after first vaccination (day 15).|For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.|||Percentages of subjects||95% Confidence Interval|Number
2649150|NCT01680016|Primary|Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After the First Vaccination in Older Adults Aged ≥51 Years|Immunogenicity was measured as the GMCs of Rabies Virus Neutralizing Antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 14 days after first vaccination (day 15).|Analysis was done on the PP set.|||IU/mL||95% Confidence Interval|Geometric Mean
2649151|NCT01680016|Primary|Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years.|Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Before vaccination (day 1) and 14 days after first vaccination (day 15)|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||IU/mL||95% Confidence Interval|Geometric Mean
2649152|NCT01679613|Secondary|Area Under the Curve From 0 to the Last Quantifiable Concentration (AUC0-tz)|"AUC0-tz represents the area under the plasma concentration-time curve of nintedanib from time 0 to the last quantifiable nintedanib plasma concentration.~For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities"|1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration|TS|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2649153|NCT01679613|Primary|Maximum Measured Concentration (Cmax)|"Cmax represents the maximum concentration of nintedanib in plasma~For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities"|1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration|TS|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2649215|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 5|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients|||percentage of patients|||Number
2649154|NCT01679613|Primary|Area Under the Curve From 0 Extrapolated to Infinity (AUC0-∞)|"AUC0-∞ represents the Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity~For this endpoint, the measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities"|1 hour (h) before drug administration and 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h and 72h after the drug administration|The treated set (TS) includes all subjects who were dispensed study medication and were documented to have taken at least one dose of study medication (nintedanib or ketoconazole).|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2649155|NCT01679600|Primary|Peak Oxygen Uptake (V'O2peak)||4 weeks||||mL/min||Standard Deviation|Mean
2649156|NCT01679405|Secondary|Tumor Control Rate|Tumor control rate is defined as the best tumour response (confirmed partial or complete response, stable disease) that is achieved until end of treatment according to Recist 1.1.|Treatment period: up to eight cycles (maximum 8 months).|For one patient there was no CT assessment.|||Participants|||Count of Participants
2649157|NCT01679405|Secondary|Objective Response Rate|Response was assessed by means of RECIST 1.1 criteria for target lesions, non-target lesions and the appearance of new lesions. Objective response was defined as the CR, PR or SD at end of treatment|Treatment period: up to eight cycles (maximum 8 months).|For one patient, there was no CT assessment.|||Participants|||Count of Participants
2649158|NCT01679405|Secondary|Overall Survival (OS)|Median overall survival time including the 95% confidence interval were determined using Kaplan-Meier estimates.|Time from start of treatment to death due to any cause. Time to last observation will be used if a patient has not died and OS for the patient will be considered censored. Estimated time period: up to 76 weeks||||days||95% Confidence Interval|Median
2649159|NCT01679405|Secondary|Time to Progress (TTP)|Median time to progress (according to RECIST 1.1 criteria) including the 95% confidence intervals were determined using Kaplan-Meier estimates. Time from start of treatment to first documentation of objective tumour progression. Deaths were censored at the time of death.|Treatment period: up to eight cycles (maximum 8 months). 12 months follow-up period.||||days||95% Confidence Interval|Median
2649160|NCT01679405|Primary|Number of Adverse Events|"In part A the maximum tolerated dose (MTD) of BIBW 2992 administered continuously to the standard therapy of Gemcitabine / Cisplatin (Gem/Cis) (administered together on day 1 and 8 of a three-week cycle) will be evaluated in a 2 step dose escalation.~Safety and toxicity will be evaluated as described and considered primary for part B of the study."|Treatment period: up to eight cycles (maximum 8 months). 12 months follow-up period.||||Participants|||Count of Participants
2649161|NCT01679314|Secondary|Change in Change in EuroQol, 5 Questions and 3 Levels (EQ-5D-3L), Visual Analogue Scale (VAS)|Visual analogue scale (VAS) 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state|Baseline vs 8 weeks|One patient in the Active AlphaCore group missing data at 8 weeks.|||units on a scale||Standard Deviation|Mean
2649162|NCT01679314|Secondary|Number of Subjects With Adverse Events (AE)|"All AEs including but not limited to events reported by the subject or reported in response to an open question by the Clinical Investigator or member of this team, which fall into any of the above definitions must be recorded as an AE in the Case Report Form (CRF) and should include the following information.~Brief description of the event (diagnosis)~Start date (and time, if relevant)~Stop date (and time, if relevant) (or resolution)~Severity~Action taken regarding the medical device~Opinion on causality~Seriousness~Outcome"|Throughout the course of the study (baseline to the 4 month follow-up visit)|All subjects reporting any Adverse Event|||participants|||Number
2649163|NCT01679314|Secondary|Change in EuroQol, 5 Questions and 3 Levels (EQ5D-3L)|"The EQ-5D-3L (EuroQoL 5 questions and 3 answering levels) during the run-in period will be compared with the EQ-5D-3L during the treatment period. And treatment period will be compared to open label.~Rating of questions Level 1 no problems Level 2 some problems Level 3 Significant problems Worst case is 15 points and best case is 5 points using index"|Baseline vs 8 weeks|One patient in the Active AlphaCore group is missing data at 8 weeks.|||participants|||Number
2649164|NCT01679314|Secondary|Change in Forced Expiratory Volume (FEV1)|"Forced Expiratory Volume (FEV1): Maximum volume that can be exhaled in the first second - after maximum inhalation.~Change from baseline to week 8 between treatment groups"|Baseline vs 8 weeks|One subject in the Active AlphaCore group missing data at week 8|||Percentage of predicted value||Standard Deviation|Mean
2649165|NCT01679314|Secondary|Change 6 Minutes Walking Test|Six minutes walking test: Measure distance (meter) after 6 minutes walk. Change from Baseline between treatment groups|Baseline vs 8 weeks|One patient in the Active AlphaCore group is missing data at week 8|||Meter||Standard Deviation|Mean
2649166|NCT01679314|Secondary|Change in Borg Dyspnoea Scores|Borg dyspnoea scale (Physical activity test): 0 - 11 (Not at all effected - Extremely effected) The result show the change between the the treatment groups from baseline to week 8|Baseline vs 8 weeks|One subject in the Active AlphaCore device Group missing data at 8 weeks.|||Scores on a scale||Standard Deviation|Mean
2649167|NCT01679314|Primary|Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores (Quality of Life and Symptoms) Changes Within a Treatment Period and Comparison Between the Two Groups|Chronic obstructive pulmonary disease Assessment Test (CAT) scores (Quality of life and symptoms) changes within a treatment period and comparison between the two groups. Eight (8) questions. The scale is rated from 0 to 5, min = 0, max = 5. Low rates = better, high rates = worse. Mean change in the period 8 weeks versus baseline.|8 weeks|One patient in the Active AlphaCore device Group missing data at 8 weeks.|||units on a scale||95% Confidence Interval|Least Squares Mean
2649168|NCT01679301|Primary|Oxygen Saturation Values Obtained From Pulse Oximetry|A comparison of the average oxygen saturation values obtained via pulse oximetry during continous flow oxygen versus 'sleep' mode while sleeping|Day 1||||percentage of oxygen saturation (SpO2)||Standard Deviation|Mean
2649169|NCT01679236|Secondary|Alcohol Use in Study Subjects vs Controls|Timeline follow back participant self-report of daily alcohol use.|2 weeks post quit day|||||||
2649170|NCT01679236|Primary|Smoking Abstinence|Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects two weeks after the quit day|2 weeks post quit day|total enrolled|||participants|||Number
2649171|NCT01679197|Secondary|Body Weight||1 year||||kg||Standard Deviation|Mean
2649175|NCT01679197|Secondary|Liver Fat by MRI and MR Spectroscopy|All enrolled patients will have a baseline MRI of the liver to evaluate liver volume and liver fat. For determination of hepatic fat content by MRI and MR spectroscopy in patients, a series of out-phase and in-phase MRI at multiple flip angles are used. By combination of out-phase and in-phase MRI at multiple flip-angles and TE times, relaxation-time effects can be removed to yield quantitative intra-hepatic (and other organs') fractional fat content throughout the liver in a few breath-hold intervals.|1 year|The number of participants analyzed at month 12 differs from the overall number analyzed at baseline because 4 participants dropped from the study before their month 12 visit.|||%fat||Standard Deviation|Mean
2649176|NCT01679197|Primary|Liver Histopathology|Primary outcome will be the total non-alcoholic steatohepatitis (NASH) score read histopathologically from the liver biopsy samples. This outcome measure quantifies the severity of fatty liver disease. At baseline and at the end of the year, patients have undergone a transcutaneous liver biopsy and the specimens were graded for the severity of non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH) pathology. Histological features of NAFLD/NASH were scored using the validated NASH-CRN (NASH Clinical Research Network) scoring system. This scoring system is the total of 4 subscales: steatosis (0-3), lobular inflammation (0-3), hepatocellular ballooning (0-2) and fibrosis (0-4), which are evaluated semi-quantitatively. The total scale range for this scoring system is 0-12, with 0 representing no features of fatty liver disease, and 12 representing the highest degree of fatty liver disease.|1 year|The number of participants analyzed at month 12 differs from the overall number analyzed at baseline because 4 participants dropped from the study before their month 12 visit.|||units on a scale||Standard Deviation|Mean
2649177|NCT01679028|Primary|Incidence of Adverse Drug Events and Serious Adverse Events|the Incidence of Adverse Drug Events and serious adverse events|30 days (after first dosing)||||adverse event|||Number
2649178|NCT01679002|Secondary|Number of of Subjects Reporting at Least One Adverse Event|Number of of subjects reporting at least one adverse event.|8 weeks|The results are related to overall population in the study devided by period of treatment.|||Number of of subjects reporting at least|||Number
2649179|NCT01679002|Secondary|AUC - Area Under the Plasma Concentration Versus Time Curve|"AUC - Area Under the Plasma Concentration Versus Time Curve for BIA 2-093 metabolites:~BIA 2-194 BIA 2-195 Oxcarbazepine"|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose|The results are related to overall population in the study devided by period of treatment.|||ng*h/mL||Standard Deviation|Mean
2649180|NCT01679002|Primary|Cmax - Maximum Observed Plasma Drug Concentration|"Cmax - maximum observed plasma drug concentration for BIA 2-093 metabolites:~BIA 2-194 BIA 2-195 Oxcarbazepine"|pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 h post-dose|The results are related to overall population in the study devided by period of treatment.|||ng/mL||Standard Deviation|Mean
2649181|NCT01678976|Other Pre-specified|Total of Subjects Reporting at Least One Adverse Event|Monitoring of Adverse Events throughout the study: Safety was evaluated from the number of reported adverse events (AEs) by patient|4 weeks||||subjects reporting at least 1 AE|||Number
2649182|NCT01678976|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC)|Area under the plasma concentration versus time curve (AUC) to last measurable time point (AUC0-t) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.|at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose|Values are described for single dose of BIA 2-093 or oxcarbazepine respectively for Group 1 and 2.|||ng*h/mL||Standard Deviation|Mean
2649183|NCT01678976|Primary|Maximum Drug Concentration (Cmax)|Maximum observed plasma concentration (Cmax) was acessed for BIA 2-093 metabolites (BIA 2-194; BIA 2-195) and Oxcarbazepine.|at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose|Values are described for single dose of BIA 2-093 or oxcarbazepine respectively for Group 1 and 2.|||ng/mL||Standard Deviation|Mean
2649184|NCT01678924|Secondary|Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 12|Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.|Baseline to Week 12|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.|||units on a scale||95% Confidence Interval|Least Squares Mean
2649185|NCT01678924|Secondary|Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 8|Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.|Baseline to Week 8|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.|||units on a scale||95% Confidence Interval|Least Squares Mean
2649186|NCT01678924|Secondary|Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 4|Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.|Baseline to Week 4|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.|||units on a scale||95% Confidence Interval|Least Squares Mean
2649216|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 4|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients|||percentage of patients|||Number
2649187|NCT01678924|Secondary|Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 2|Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.|Baseline to Week 2|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.|||units on a scale||95% Confidence Interval|Least Squares Mean
2649188|NCT01678924|Secondary|Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12|Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.|Baseline to Week 12|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2649189|NCT01678924|Secondary|Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 8|Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.|Baseline to Week 8|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2649190|NCT01678924|Secondary|Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4|Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.|Baseline to Week 4|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2649191|NCT01678924|Secondary|Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 2|Assessment of evoked pain were conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). Evoked pain was scored using a visual analog scale (VAS; 0 to100 mm scale with anchors of 0 = No pain and 100 = Worst pain imaginable). The patient was asked to use the VAS to rate the unpleasantness of 3 brush strokes within the center of the area of allodynia and pain.|Baseline to Week 2|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population.|||units on a scale||95% Confidence Interval|Least Squares Mean
2649192|NCT01678924|Secondary|Change From Baseline in Area of Allodynia - Cohort 2 - Week 12|The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.|Baseline to Week 12|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.|||Square Centimeters (cm^2)||95% Confidence Interval|Least Squares Mean
2649193|NCT01678924|Secondary|Change From Baseline in Area of Allodynia - Cohort 2 - Week 8|The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.|Baseline to Week 8|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.|||Square Centimeters (cm^2)||95% Confidence Interval|Least Squares Mean
2649194|NCT01678924|Secondary|Change From Baseline in Area of Allodynia - Cohort 2 - Week 4|The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.|Baseline to Week 4|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.|||Square Centimeters (cm^2)||95% Confidence Interval|Least Squares Mean
2649217|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 3|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients|||percentage of patients|||Number
2649195|NCT01678924|Secondary|Change From Baseline in Area of Allodynia - Cohort 2 - Week 2|The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.|Baseline to Week 2|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.|||Square Centimeters (cm^2)||95% Confidence Interval|Least Squares Mean
2649196|NCT01678924|Secondary|Change From Baseline in Area of Allodynia - Cohort 1 - Week 12|The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.|Baseline to Week 12|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.|||Square Centimeters (cm^2)||95% Confidence Interval|Least Squares Mean
2649197|NCT01678924|Secondary|Change From Baseline in Area of Allodynia - Cohort 1 - Week 8|The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.|Baseline to Week 8|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.|||Square Centimeters (cm^2)||95% Confidence Interval|Least Squares Mean
2649198|NCT01678924|Secondary|Change From Baseline in Area of Allodynia - Cohort 1 - Week 4|The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.|Baseline to Week 4|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.|||Square Centimeters (cm^2)||95% Confidence Interval|Least Squares Mean
2649199|NCT01678924|Secondary|Change From Baseline in Area of Allodynia - Cohort 1 - Week 2|The assessment of maximal area of allodynia was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their maximal area of skin that feels unpleasant to the touch (allodynic skin) with a red marker. Areas of allodynia were quantified at a central reading center.|Baseline to Week 2|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 1 is 154 patients.|||Square Centimeters (cm^2)||95% Confidence Interval|Least Squares Mean
2649200|NCT01678924|Secondary|Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 12|The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.|Baseline to Week 12|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.|||Square Centimeters (cm^2)||95% Confidence Interval|Least Squares Mean
2649201|NCT01678924|Secondary|Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 8|The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.|Baseline to Week 8|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.|||Square Centimeters (cm^2)||95% Confidence Interval|Least Squares Mean
2649202|NCT01678924|Secondary|Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 4|The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.|Baseline to Week 4|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients.|||Square Centimeters (cm^2)||95% Confidence Interval|Least Squares Mean
2649203|NCT01678924|Secondary|Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 2|The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.|Baseline to Week 2|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. The mITT population for Cohort 2 is 125 patients|||Square Centimeters (cm^2)||95% Confidence Interval|Least Squares Mean
2649204|NCT01678924|Secondary|Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12|The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.|Baseline to Week 12|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population|||Square Centimeters (cm^2)||95% Confidence Interval|Least Squares Mean
2649205|NCT01678924|Secondary|Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8|The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.|Baseline to Week 8|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population|||Square Centimeters (cm^2)||95% Confidence Interval|Least Squares Mean
2649206|NCT01678924|Secondary|Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4|The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient in which the patient was asked to outline their MASP with a black marker. Areas of pain were quantified at a central reading center.|Baseline to Week 4|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population|||Square Centimeters (cm^2)||95% Confidence Interval|Least Squares Mean
2649207|NCT01678924|Secondary|Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2|The assessment of maximal area of spontaneous pain (MASP) was conducted by a qualified and trained investigator or designee (eg, physician, physician's assistant, nurse practitioner, and nurse). This assessment is based on color photographs taken of the patient and that the patient was asked to circle their MASP on with a black marker. Areas of pain were quantified at a central reading center.|Baseline to Week 2|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score assessment. Cohort 1 includes 154 patients from the mITT population|||Square Centimeters (cm^2)||95% Confidence Interval|Least Squares Mean
2649208|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 12|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients|||percentage of patients|||Number
2649209|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 11|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 11|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients|||percentage of patients|||Number
2649210|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 10|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 10|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients|||percentage of patients|||Number
2649211|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 9|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 9|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients|||percentage of patients|||Number
2649212|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 8|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 8|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients|||percentage of patients|||Number
2649213|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 7|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients|||percentage of patients|||Number
2649214|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 6|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients|||percentage of patients|||Number
2649532|NCT01676701|Primary|PK: Area Under the Concentration Time Curve From Time 0 to 14 Days [AUC(0-14)]||Days 4, 7, 9, 11, and 14 after loading dose administered|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
2649218|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 2|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients|||percentage of patients|||Number
2649219|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 1|The total mITT population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. The mITT population for Cohort 2 is 125 patients|||percentage of patients|||Number
2649220|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 12|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population|||percentage of patients|||Number
2649221|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 11|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population|||percentage of patients|||Number
2649222|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 10|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population|||percentage of patients|||Number
2649223|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 9|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population|||percentage of patients|||Number
2649224|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 8|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population|||percentage of patients|||Number
2649225|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 7|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population|||percentage of patients|||Number
2649226|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 6|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population|||percentage of patients|||Number
2649227|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 5|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population|||percentage of patients|||Number
2649228|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease), and in 10% increments, up to 100% improvement, in average pain intensity score at each week compared with baseline|Baseline to Week 4|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population|||percentage of patients|||Number
2649229|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 3|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population|||percentage of patients|||Number
2649230|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 2|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population|||percentage of patients|||Number
2649231|NCT01678924|Secondary|Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1|Average Pain Intensity Score Responder is defined as a patient who had at least a 30% improvement (decrease) in average pain intensity score at each week compared with baseline|Baseline to Week 1|The total modified intent to treat (mITT) population of 279 patients, consists of all randomized patients who received treatment and at least 1 post-baseline weekly average pain intensity score. Cohort 1 includes 154 patients from the mITT population|||percentage of patients|||Number
2649232|NCT01678924|Primary|Change From Baseline in Average Pain Intensity Score - Cohort 2|"The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. patients used the 11-point Likert scale, with anchors at 0 = no pain and 10 = pain as bad as you can imagine Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment."|Baseline to Week 12|Two cohorts of patients with postherpetic neuralgia (PHN) were randomized to receive 1 treatment of either AGN-214868 (cohort 1: 32.5 or 65 μg; cohort 2: 130 μg) or placebo. Cohort 2 includes 125 patients from the mITT population|||units on a scale||95% Confidence Interval|Least Squares Mean
2649233|NCT01678924|Primary|Change From Baseline in Average Pain Intensity Score - Cohort 1|"The average pain intensity score at each week was the mean of the daily average pain intensity scores reported in the patient's eDiary during each 7-day period, starting with the day of study treatment injection. Patients used the 11-point Likert scale, with anchors at 0 = no pain and 10 = pain as bad as you can imagine Baseline was defined as the mean of the daily average pain intensity scores reported during the baseline period for the 7 days immediately prior to the treatment."|Baseline to Week 12|Two cohorts of patients with postherpetic neuralgia (PHN) were randomized to receive 1 treatment of either AGN-214868 (cohort 1: 32.5 or 65 μg; cohort 2: 130 μg) or placebo. Cohort 1 includes 154 patients from the modified intent to treat (mITT) population|||units on a scale||95% Confidence Interval|Least Squares Mean
2649234|NCT01678911|Secondary|Patient Global Impression of Change|Patient Global Impression of Change is a self-report questionnaire on which patient indicate their perceived impression of change since the start of the study given the following options: Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, or Very much Worse.|4 Visits over 15 weeks||||participants|||Number
2649235|NCT01678911|Secondary|Center for Epidemiologic Studies Depression Scale|The CES-D 10 is a 10-item questionnaire that has been validated for the assessment of depressive symptomatology. The Depression Scale is a scale with a sum score from 0 - 30, where 0 = no Depression and 30 = the most Depression.|4 visits over 15 week period||||units on a scale||Standard Deviation|Mean
2649236|NCT01678911|Secondary|Pain Disability Index|The PDI is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.|4 visits over an 8 week period||||units on a scale||Standard Deviation|Mean
2649237|NCT01678911|Secondary|Pain Anxiety Symptoms Scale|The Pain Anxiety Symptoms Scale (PASS) is an anxiety scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.|4 Visits over an 8 week period||||units on the PASS scale||Standard Deviation|Mean
2649238|NCT01678911|Primary|McGill Pain Questionnaire - Short Form|The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are averaged to compute a total score. The scale ranges from 0-10 (0=no pain, 10=the most pain).|4 Visits over a 15 week period||||units on a scale||Standard Deviation|Mean
2649239|NCT01678898|Other Pre-specified|Gastrointestinal Symptoms Questionnaire - Frequency of Diarrhea|A qualitative assessments regarding abdominal pain and diarrhea at baseline, 3-month, 6-month, 9-month, and 12-month visits. The subjects were asked to report their frequency of diarrhea as never, rarely, monthly, weekly, or daily. The number of subjects who reported never or rarely having diarrhea at the 12-month visit is reflected.|The Gastrointestinal Symptoms Questionnaire is assessed at baseline, 3-month, 6-month, 9-month, and 12-month visits.||||Participants|||Count of Participants
2649240|NCT01678898|Other Pre-specified|Gastrointestinal Symptoms Questionnaire - Frequency of Abdominal Pain|A qualitative assessments regarding abdominal pain and diarrhea at baseline, 3-month, 6-month, 9-month, and 12-month visits. The subjects were asked to report their frequency of abdominal pain as never, rarely, monthly, weekly, or daily. The numbers of subjects who reported never or rarely having abdominal pain at the 12-month visit are reflected.|The Gastrointestinal Symptoms Questionnaire is assessed at baseline, 3-month, 6-month, 9-month, and 12-month visits.||||Participants|||Count of Participants
2649241|NCT01678898|Other Pre-specified|Gastrointestinal Symptoms Questionnaire - Severity of Abdominal Pain|A qualitative assessments regarding abdominal pain and diarrhea at baseline, 3-month, 6-month, 9-month, and 12-month visits. The subjects were asked to report the severity of their abdominal pain as no pain, mild, moderate, severe or really severe. The number of subjects who reported no or mild abdominal pain at the 12-month visit are reflected.|The Gastrointestinal Symptoms Questionnaire is assessed at baseline, 3-month, 6-month, 9-month, and 12-month visits.||||participants|||Number
2649242|NCT01678898|Other Pre-specified|Change in Mainz Severity Score Index (MSSI)|The Mainz Severity Score Index (MSSI) is useful for monitoring clinical improvement in patients receiving enzyme replacement therapy. The MSSI scoring system is composed of four sections that cover the general, neurological,cardiovascular and renal signs and symptoms of Fabry disease. Each section includes a group of signs and symptoms that are associated with Fabry disease. The minimal score is 0, and the maximum score for the general section is 18. A higher score indicates more severe clinical manifestations of the disease.The MSSI is performed at baseline, 6-month, and 12-month. The overall mean reduction of the total general score at 12-month from baseline is reflected.|The MSSI is performed at baseline, 6-month, and 12-month||||score of a scale||Standard Error|Mean
2649243|NCT01678898|Other Pre-specified|Brain MRI|Qualitative assessments regarding evidence of stroke using brain MRI were summarized at baseline and 12-month visits. Number is subjects with evidence of stoke on the brain MRI at the 12-month visit is reflected.|Brain MRI is performed at baseline and 12-month visit.||||Participants|||Count of Participants
2649533|NCT01676701|Primary|Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Tabalumab After Loading Dose||Days 4, 7, 9, 11, and 14 after loading dose administered|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
2649244|NCT01678898|Other Pre-specified|Total Urine Protein Level|Proteinuria is assessed using spot urine tests at baseline, 3-month, 6-month, 9-month, and 12-month visits. The percent changes of total urine protein level at the 12-month visit from baseline is reflected.|Total urine protein level is assessed at baseline, 3-month, 6-month, 9-month, and 12-month visits.||||Percentage change from baseline||Standard Error|Mean
2649245|NCT01678898|Other Pre-specified|Urine Protein/Creatinine Ratio|Proteinuria is assessed using spot urine tests at baseline, 3-month, 6-month, 9-month, and 12-month visits. The percent changes of urine protein/creatinine ratio at the 12-month visit from baseline is reflected.|Protein/.creatinine ratio is assessed at baseline, 3-month, 6-month, 9-month, and 12-month visits||||Percentage change from baseline||Standard Error|Mean
2649246|NCT01678898|Other Pre-specified|Urine Creatinine Level|Proteinuria is assessed using spot urine tests at baseline, 3-month, 6-month, 9-month, and 12-month visits. The percent changes of urine creatinine level at the 12-month visit from baseline is reflected.|Urine creatinine level is assessed at baseline, 3-month, 6-month, 9-month, and 12-month visits using spot urine tests.||||Percentage change from baseline||Standard Error|Mean
2649247|NCT01678898|Other Pre-specified|Change in Short Form Brief Pain Inventory (BPI)|Pain severity (worst, least, average, and right now) is summarized at baseline, 3-month, 6-month and 12-month of the study. The Short Form Brief Pain Inventory (BPI) is based on a 10-point scale, where 0=no pain and 10=pain as bad as you can imagine. A reduction in pain severity score indicated an improvement. The changes from baseline for individual scores and composite scores (a mean severity score) was assessed. The mean change in score from baseline at the 12-month visit is reflected.|The Short Form Brief Pain Inventory (BPI) is assessed at baseline, 3-month, 6-month, and 12-month visits.||||score on a scale||Standard Error|Mean
2649248|NCT01678898|Other Pre-specified|Number of Participants With Anti-Drug Antibodies|Results reported represent the number of participants who were tested positive for anti-pegunigalsidase alfa (PRX-102) antibodies, including neutralizing antibodies in patients having a positive IgG antibody response per group, at Visit 1, 2 (Month 1), and then every 2 months during the study, and 2 months after the last infusion.|Anti-pegunigalsidase alfa (PRX-102) antibodies, including neutralizing antibodies in patients having a positive IgG antibody response, were assessed at Visit 1, 2 (Month 1), and then every 2 months during the study, and 2 months after the last infusion.||||participants|||Number
2649249|NCT01678898|Other Pre-specified|Pharmacokinetics - Cmax|"Pharmacokinetic (PK) parameters were derived from the plasma concentration versus time profiles.~Cmax is the maximal plasma concentration of a drug after administration. Results reported represent the averaged values following a single dosing of the study drug."|PK parameters were determined on Day 1 and 3, 6, and 12 months at these time points: pre-infusion (baseline); 1 h after the beginning of the infusion; at the end of the infusion; 1, 4, 8, 24, 48±3, 72±3, 96±3 h and 2 weeks ± 3 days post-infusion.||||ng/ml||Standard Error|Mean
2649250|NCT01678898|Other Pre-specified|Pharmacokinetics - Volume of Distribution (Vz)|PK parameters were derived from the plasma concentration versus time profiles. Vz is the volume of distribution during the elimination phase. Results reported represent the averaged values following a single dosing of the study drug.|PK parameters were determined on Day 1 and 3, 6, and 12 months at these time points: pre-infusion (baseline); 1 h after the beginning of the infusion; at the end of the infusion; 1, 4, 8, 24, 48±3, 72±3, 96±3 h and 2 weeks ± 3 days post-infusion.||||ml/kg||Standard Error|Mean
2649251|NCT01678898|Other Pre-specified|Pharmacokinetics - Clearance of Drug (Cl)|"PK parameters were derived from the plasma concentration versus time profiles. Clearance of drug from plasma represents the volume of plasma cleared of the drug per unit time per Kg.~Results reported represent the averaged values following a single dosing of the study drug."|PK parameters were determined on Day 1 and 3, 6, and 12 months at these time points: pre-infusion (baseline); 1 h after the beginning of the infusion; at the end of the infusion; 1, 4, 8, 24, 48±3, 72±3, 96±3 h and 2 weeks ± 3 days post-infusion.||||ml/hr/kg||Standard Error|Mean
2649252|NCT01678898|Other Pre-specified|Pharmacokinetics - Terminal Half Life|PK parameters were derived from the plasma concentration versus time profiles. Results reported represent the averaged values following a single dosing of the study drug.|PK parameters were determined on Day 1 and 3, 6, and 12 months at these time points: pre-infusion (baseline); 1 h after the beginning of the infusion; at the end of the infusion; 1, 4, 8, 24, 48±3, 72±3, 96±3 h and 2 weeks ± 3 days post-infusion.||||hour||Standard Error|Mean
2649253|NCT01678898|Other Pre-specified|Pharmacokinetics - AUC|PK parameters were derived from the plasma concentration versus time profiles. Results reported represent the averaged values following a single dosing of the study drug.|PK parameters were determined on Day 1 and 3, 6, and 12 months at these time points: pre-infusion (baseline); 1 h after the beginning of the infusion; at the end of the infusion; 1, 4, 8, 24, 48±3, 72±3, 96±3 h and 2 weeks ± 3 days post-infusion.||||ng*hr/ml||Standard Error|Mean
2649254|NCT01678898|Other Pre-specified|Cardiac MRI - LVMI|Cardiac MRI with computer-calculated left ventricular mass index were conducted at baseline, 6 month, and 12 months. Results are presented as mean percent change from baseline (visit 1) to 12 months. LVMI is calculated by dividing the left ventricular mass by body surface area.|Cardiac MRI was performed 3 times: at baseline (visit 1), 6 months and 12 months.||||Percent Change||Standard Error|Mean
2649255|NCT01678898|Other Pre-specified|Cardiac MRI - LVM|Results are presented as mean percent change from baseline (visit 1) to 12 months.|Cardiac MRI was performed 3 times: at baseline (visit 1), 6 months and 12 months.||||Percent change||Standard Error|Mean
2649256|NCT01678898|Other Pre-specified|Cardiac MRI - Ejection Fraction|Results are presented as mean percent change from baseline (visit 1) to 12 months.|Cardiac MRI was performed 3 times: at baseline (visit 1), 6 months and 12 months.||||Percent Change||Standard Error|Mean
2649257|NCT01678898|Other Pre-specified|Cardiac Fibrosis Per MRI|"Cardiac MRI was performed to estimate the percentage and mass of the myocardial fibrotic area.~Results represent the number of subjects with fibrosis after 1 year of treatment."|Cardiac MRI was performed in order to assess myocardial fibrosis at baseline, 6 months and 12 months visit.||||number of subjects|||Number
2649271|NCT01678820|Secondary|Percentage of Participants With A1C Level <7% at Week 16|Percentage of participants achieving glycemic goal (A1C <7%) after 16 weeks of treatment. Data as observed.|Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percentage of participants|||Number
2649258|NCT01678898|Other Pre-specified|Change in Kidney Gb3 Accumulation|Kidney biopsy was performed at baseline of study PB-102-F01 and following 6 months treatment with PRX-102. Approximately 300 capillaries were scored in each specimen. A quantitative Barisoni Lipid Inclusion Scoring System (BLISS) was used for scoring Gb3 inclusions in kidney peritubular capillary (PTC) biopsy samples.The scoring system was implemented by 3 blinded pathologists/readers.The BLISS scoring methodology consists of counting the number of Gb-3 inclusions per capillary previously annotated.The final score of each biopsy was the average number of inclusions per capillary. A decrease in scoring from baseline to 6 Month is considered an indication for clinical improvement.|Visit 1 (day 1) in PB-102-F01 study and after a total of 6 months of treatment (i.e., at 3 months into study PB-102-F02).|3 patients were not included in the renal biopsies Gb3 analysis. 1 male patient's biopsies were mixed up by the lab; 1 female patient's baseline biopsy didn't include cortex tissue making sample unreadable; and 1 male patient carries a cardiac GLA variant (p.N215S) associated with rare renal manifestation and had a low BLISS baseline score|||Percent change||Standard Error|Mean
2649259|NCT01678898|Other Pre-specified|Plasma Lyso-Gb3 Levels|Results are presented as mean percent change from baseline (visit 1) to 12 months +/- standard error.|Plasma Lyso-Gb3 concentration (ng/mL) was measured at baseline and every 3 months up to 12 months.||||mean percent change||Standard Error|Mean
2649260|NCT01678898|Other Pre-specified|Kidney Function - Change in eGFR|Estimated glomerular filtration rate (eGFR) was calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. Levels of eGFR calculated by the CKD-EPI equation, based on measured serum creatinine on day 1, weeks 4, 8, 12, 26, 38 and 52 are used to determine the annualized slope of eGFR per patient over a 12 months period. The absolute mean change from baseline (visit 1) to 12 months is then derived from the eGFR slope.|eGFR is performed at baseline (day 1) weeks 4, 8, 12, 26, 38 and 52 (12 months)||||mL/min/1.73 m2||Standard Error|Mean
2649261|NCT01678898|Other Pre-specified|Plasma Gb3 Concentrations|Results are presented as mean percent change from baseline (visit 1) to 12 months +/- standard error.|Plasma Gb3 concentration (ug/mL) was measured at baseline and every 3 months up to 12 months.||||mean percent change||Standard Error|Mean
2649262|NCT01678898|Primary|Adverse Events|Reportings of adverse events reported by the patient and from monitoring with clinical laboratory, physical examination and ECG. Results represent the number of AEs that were considered possibly, probably, or definitely related to treatment.|12 months||||adverse events|||Number
2649263|NCT01678885|Secondary|Device Predictions of % Weight Change During and After an 8-week LCD|This secondary aim of the study was evaluated with linear regression analysis to determine if TEE, AEE, or measures of posture allocation predicted weight loss during the 8-week LCD. Percent weight change from diet initiation to termination was the dependent variable for the weight loss regressions. Of the 87 participants considered for these secondary analyses, five were excluded because they did not finish baseline accelerometry assessment, and an additional five were excluded because they did not enter the LCD phase due to BMI's < 25. Finally, seven more participants from this original sample were excluded because they did not successfully complete all aspects of the DLW dosing period. Finally, an additional 4 subjects were lost to follow up during the 8-week LCD period. Thus, 66 participants were included in the analysis|8 weeks|Participants from sub-study 1 and 2 combined were used in this analysis.|||R squared|||Number
2649264|NCT01678885|Secondary|Total Energy Expenditure (TEE) and Activity Energy Expenditure (AEE) Predictions From Actical, IDEEA, and Sensewear Monitors (kcal/Day)|Bland-Altman analyses compared the TDEE and AEE from the Sensewear® and IDEEA and Actical monitors to the DLW data from the week participants wore the monitors. Only the week of DLW data that corresponded with the wearing of the monitors was used for this analysis.|1 week|Of the 87 participants considered from phase 1 of sub-studies 1 and 2, five were excluded because they did not finish baseline accelerometry assessment, five were excluded because they did not enter the LCD due to BMI’s < 25. Seven were excluded because they did not successfully complete all aspects of the DLW dosing period.|||kcal/day||Standard Deviation|Mean
2649265|NCT01678885|Secondary|Weight Change|The secondary aim was to test if posture allocation (the amount of time spent engaging in certain behaviors e.g., sitting, walking, running, changing positions and the energy burned during these activities) predicts weight change over one year following a period of weight loss.|1 year|Weight change was evaluated from all participants who received the low calorie diet in sub-studies 1 and 2 combined.|||kg||Standard Deviation|Mean
2649266|NCT01678885|Primary|ENERGY BALANCE EQUATION, PHASE I, ONE SUB-STUDY|A new method of digital photography of foods to measure the energy intake (EI) and macronutrient intake of free-living humans was tested. Digital photography (RFPM) EI was tested against measured food provisions during an in-feeding period and against EI measured with doubly labeled water (DLW) during free-living conditions for 1 week. EI measured by directly weighing food provisions in the clinic over two days and measuring food intake during free-living conditions over one week with the DLW.|~6 days|Free-living energy intake data were analyzed from the 40 participants who completed the protocol and provided urine samples for doubly labeled water analysis. This primary outcome measure was limited to one sub-study.|||kCal||Standard Deviation|Mean
2649267|NCT01678846|Secondary|Safety and Well-being at School|"Five questions. Each question asked with response options: all the time, most of the time, sometimes, never:~I feel that my teachers care about me. I feel safe in school. I feel like I belong at school. I like to spend time at school. I am scared of my teachers (reverse coded). Scores summed, modelled as a continuous variable. Range 0 (low) to 15 (high). Higher score is better safety and well-being at school."|At 2 year follow-up||||units on a scale||Standard Deviation|Mean
2649268|NCT01678846|Secondary|Educational Achievement: Word Recognition in English|Word recognition in English(words per minute). Early Grade Reading Assessment, Uganda version. Calculated as number of words read correctly (out of a maximum of 50), divided by the time (out of a maximum of 60 seconds).|2-year follow-up||||words per minute||Standard Deviation|Mean
2649269|NCT01678846|Secondary|Child Mental Health|score on the Strengths and Difficulties Questionnaire (SDQ): 20 questions. Total difficulties score, divided by the number of completed items. Modelled as a continuous variable. Range 0 (no difficulties) to 2 (high difficulties).|2-year follow-up||||units on a scale||Standard Deviation|Mean
2649270|NCT01678846|Primary|Physical Violence From School Staff|past week experience of any physical violence from school staff|2-year follow-up||||participants|||Number
2649534|NCT01676532|Other Pre-specified|Ontario Health Insurance Plan (OHIP)Status|OHIP status of students attending the clinic was not reported or collected|1 year|||||||
2649272|NCT01678820|Secondary|Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percent change||95% Confidence Interval|Least Squares Mean
2649273|NCT01678820|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percent change||95% Confidence Interval|Least Squares Mean
2649274|NCT01678820|Secondary|Percent Change From Baseline in Triglycerides (TG) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percent change||95% Confidence Interval|Mean
2649275|NCT01678820|Secondary|Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percent change||95% Confidence Interval|Least Squares Mean
2649276|NCT01678820|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percent change||95% Confidence Interval|Least Squares Mean
2649277|NCT01678820|Secondary|Percent Change From Baseline in Total Cholesterol (TC) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percent change||95% Confidence Interval|Least Squares Mean
2649278|NCT01678820|Secondary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percent change||95% Confidence Interval|Least Squares Mean
2649279|NCT01678820|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16|Change from baseline reflects the Week 16 value minus the Week 0 value.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and who had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||mg/dL||95% Confidence Interval|Least Squares Mean
2649280|NCT01678820|Secondary|Change From Baseline in A1C at Week 16 (Sitagliptin/Simvastatin FDC vs. Simvastatin)|A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. simvastatin. Results for sitagliptin are presented above under primary outcome measures.|Baseline and Week 16|FAS population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percent||95% Confidence Interval|Least Squares Mean
2649281|NCT01678820|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 16 weeks|All participants as treated population defined as all randomized participants who received at least one dose of study drug.|||Participants|||Number
2649282|NCT01678820|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|Excludes data after rescue therapy. Adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 16 weeks for non-serious AEs, up to 18 weeks for serious AEs|All participants as treated population defined as all randomized participants who received at least one dose of study drug.|||Participants|||Number
2649283|NCT01678820|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 16 (Sitagliptin/Simvastatin FDC vs. Sitagliptin)|A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent. This primary outcome measure only includes results for sitagliptin/simvastatin FDC vs. sitagliptin. Results for simvastatin are presented below under secondary outcome measures.|Baseline and Week 16|Full analysis set (FAS) population defined as all randomized participants who took at least one dose of study drug and had at least one measurement for the analysis of this outcome measure (baseline or subsequent to the first dose of study drug).|||Percent||95% Confidence Interval|Least Squares Mean
2649284|NCT01678807|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event|The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.|From first dose to last dose of treatment, up to 28 days|All randomized participants who receive at least one dose of study treatment|||Percentage of participants|||Number
2649535|NCT01676532|Other Pre-specified|Absenteeism|Outcome data comparing absenteeism in the school with the year preceding the SBHC was not collected|1 year|||||||
2649285|NCT01678807|Primary|Percentage of Participants Who Experienced At Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.|From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days|All randomized participants who receive at least one dose of study treatment|||Percentage of participants|||Number
2649286|NCT01678560|Post-Hoc|Adherence and AHI|PAP adherence in subjects who had more than 20 respiratory events per hour during the initial sleep study was compared with the PAP adherence in subjects who had less than 20 respiratory events per hour during the initial sleep study.Patient data representing subjects who had more than 20 respiratory events per hour during the initial sleep study and subjects who had less than 20 respiratory events per hour during the initial sleep study was collected across both Usual care and Wireless Care Arms.|1 year/12 months||||Participants|||Count of Participants
2649287|NCT01678560|Post-Hoc|PAP Treatment Adherence in the First 3 Months of Treatment Compared to the PAP Treatment Adherence in the Next 9 Months of Treatment|"PAP treatment Adherence in the first 3 months of treatment (according to the CMS - Centers for Medicare & Medicaid Services - criteria) was compared to the PAP treatment Adherence in the next 9 months of treatment to verify the predictability of initial adherence or non-adherence for the future adherence or non-adherence (during the year) to PAP treatment. Adherence/non-adherence was analyzed based on the PAP usage reports (downloads) from the supplied PAP device, based on the yearly, quarterly and monthly portions of the reports.~Patient data representing initial adherence or non-adherence and adherence or non-adherence during the year to PAP treatment was collected across both Usual care and Wireless Care Arms."|12 months||||Participants|||Count of Participants
2649288|NCT01678560|Secondary|Receiving Effective Treatment for Obstructive Sleep Apnea|Evaluate whether patients are effectively being treated with PAP or with alternate means of treatment for OSA (obstructive sleep apnea) at the end of 12 months.|12 months|1 subject from the Wireless group was assigned to Provent treatment. 1 subject from the Usual group was assigned to Dental device treatment. Both subjects stopped using PAP and PAP monitoring and were considered not receiving effective PAP treatment for obstructive sleep apnea. Both subjects were lost in follow-up for our research study.|||Participants|||Count of Participants
2649289|NCT01678560|Primary|Number of Participants With Positive Airway Pressure Treatment Adherence After 3 Months|Demonstrated Periodic Adherence After 3 Months of Treatment During 4-12 months defined as mean PAP use being > 4 hours per night for greater than 70% of nights|4-12 Months||||Participants|||Count of Participants
2649290|NCT01678560|Primary|Number of Participants With Positive Airway Pressure Treatment Adherence in the First 3 Months|Positive Airway Pressure Treatment Adherence defined as mean PAP use being > 4 hours per night for greater than 70% of nights.|First 3 months||||Participants|||Count of Participants
2649291|NCT01678443|Secondary|Tumor to Normal Organ Ratios|Derived from dosimetry estimates coupled with the absorbed dose to normal organs based on the administered activity of 90Y.|Up to 6 years|||||||
2649292|NCT01678443|Secondary|Progression-free Survival||Up to 6 years|||||||
2649293|NCT01678443|Secondary|Overall Survival||Up to 6 years||||days||Full Range|Mean
2649294|NCT01678443|Secondary|Overall Response Rate||Up to 6 years|||||||
2649295|NCT01678443|Primary|Percentage of Participants With Dose Limiting Toxicities (DLT) of Yttrium-90 Anti-CD45|A DLT (dose limiting toxicity) is defined as a therapy-related grade III or IV Bearman (transplant) toxicity within 30 days of transplant.|Up to 30 days after receiving study drug||||Participants|||Count of Participants
2649296|NCT01678313|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Questionnaires|"Efficacy:~Change from Baseline in the International Prostate Symptom Score (IPSS) from baseline and 3 months The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS Voiding), 3 storage questions (IPSS Storage) The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always.~Total IPSS score = IPSS voiding + IPSS Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35~Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment||||units on a scale||Standard Deviation|Mean
2649297|NCT01678313|Secondary|Change From Baseline in the IPSS Subscore (IPSS Storage) Questionnaires|"Efficacy:~Change from Baseline in the IPSS Storage from baseline and 3 months The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.~The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).~Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment||||units on a scale||Standard Deviation|Mean
2649298|NCT01678313|Secondary|Change From Baseline in the IPSS Subscore (IPSS Voiding) Questionnaires|"Efficacy:~Change from Baseline in the IPSS Voiding from baseline and 3 months. The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.~The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).~Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment||||units on a scale||Standard Deviation|Mean
2649299|NCT01678313|Secondary|Change From Baseline in the Maximum Flow Rate (Qmax)|"Efficacy:~Change from Baseline in the maximum flow rate (Qmax) from baseline and 3 months Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment||||mL/s||Standard Deviation|Mean
2649300|NCT01678313|Secondary|Change From Baseline in the Void Volume (VV)|"Efficacy:~Change from Baseline in the Void Volume (VV) from baseline and 3 months Change = Month 3 minus Baseline value"|Baseline and 3 months after initial treatment||||mL||Standard Deviation|Mean
2649302|NCT01678196|Secondary|Caregiver Burden|Caregiver Burden Scale (CBS). The CBS is a 16 items scale assessing caregiver burden. It has 16 items rated from 1 (not at all) to 5 (extremely) distressed or burdened. Scores reported are the total scale scores, calculated as the mean of the 16 items, with a range from 1 (low burden) to 5 (high burden).|3 months post-randomization|Sample sizes are smaller than total sample size due to missing questionnaire data.|||units on a scale||Standard Deviation|Mean
2649303|NCT01678196|Secondary|Family Functioning|Relationship Happiness Scale. The RHS is a 9 item scale of general happiness in close relationships. The total score is reported here, reflecting the mean of the 9 items rated on a scale of 1 (completely unhappy) to 10 (completely happy). Higher total scores reflect greater relationship happiness.|3 months after the initiation of the intervention|Sample sizes are smaller than the overall sample due to missing questionnaire data.|||units on a scale||Standard Deviation|Mean
2649304|NCT01678196|Secondary|Family Member Psychosocial Wellbeing: Brief Symptom Inventory - 18|Brief Symptom Inventory - 18 (Derogatis, 1993) is an 18 item measure of general mental health symptoms and distress. The total score is used, which is the mean of 18 items rated from 0 (not at all) to 4 (extremely) distressing. Total scores range from 0 (low distress) to 4 (high distress).|3 months after initiation of the intervention|Group sample sizes are smaller than total sample sizes due to missing data.|||units on a scale||Standard Deviation|Mean
2649305|NCT01678196|Primary|Veteran Engagement in VA Mental Health Services|Administrative data on mental health service utilization for Veterans will be compared for those whose family members receive the intervention (VA-CRAFT) and those who do not.|3 months after initiation of the intervention||||participants|||Number
2649306|NCT01678144|Other Pre-specified|Exploratory: Thickness of the Anterior Leaflet Segment A2 and the Posterior Scallop P2 of the Mitral Valve (MV) Leaflets, as Measured With the Dedicated Medtentia Leaflet Measurement Tool.||Day of surgery visit (V01)|The leaflet measuring tool was designed to compress the leaflet between two jaws to measure the thickness. Due to soft tissue getting compressed between these two jaws the measure was not seen accurate, therefore this procedure was omitted in the study.||||||
2649307|NCT01678144|Other Pre-specified|Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.||At screening and at each follow-up visit (except for discharge visit, up to 2 years).||||Participants|||Count of Participants
2649308|NCT01678144|Other Pre-specified|Exploratory: Duration of the Key Stages of the Annuloplasty Procedure.|"Duration of the following key stages of the annuloplasty procedure:~MAR implantation time (beginning with the measurement of the annulus size and ending with the completion of the last suture, but not including the time needed to measure leaflet thickness)~MAR rotation time~Suturing time (from start of annulus suturing until last knot)~Aortic clamp time~Cardiac arrest time"|Day of surgery visit (V01)|MAR rotation time assessment available for 9 patients only.|||minutes||Standard Deviation|Mean
2649309|NCT01678144|Other Pre-specified|Exploratory: Change in the Mitral Regurgitation (MR) Parameters, as Measured Using TTE.|"Change from screening at each follow-up visit in the following MR parameters, as measured using TTE:~Left ventricular inner dimension systole and diastole assessment by trans-thoracic echocardiography (the dimension of inner edge to inner edge, perpendicular to the long axis of the left ventricle, at the level of the mitral valve leaflet tips, measured at end-systole and end-diastole)~Coaptation height"|From screening to end of study (up to 2 years)|The outcome is reported for subjects and follow up visits where data is available|||millimeters||Inter-Quartile Range|Median
2649310|NCT01678144|Secondary|Performance: Percentage of Participants With Improvement by at Least 2 Mitral Regurgitation Classes at Each Follow-up Visit (V04-V06) of the Improvement in MR From Screening, as Measured by Trans-thoracic Echocardiography (TTE).|Measurement analysis at 24 months after successful MAR implantation.|V06 (24 months)|The study was terminated prematurely. Due to the smaller than planned patient group size no patient data at V04 (6 months) and V05 (12 months) was analyzed for this endpoint. The results provided are only for V06 (24 months).|||percentage of participants||95% Confidence Interval|Mean
2649311|NCT01678144|Secondary|Performance: Mitral Regurgitation (MR) as Seen in Trans-esophageal Echocardiography (TEE) Performed During Surgery Before and After Annuloplasty.|Success will be defined as no or only residual mitral regurgitation (MR).|Day of surgery visit (V01).|The data for this outcome measure was not collected.This was a part of the echocardiography investigation protocol and therefore was not documented on electronic case report form although the surgeon in charge performed the investigation on the operation table.||||||
2649312|NCT01678144|Secondary|Safety: The Occurrence, Frequency and Nature of Abnormalities in the Period From Surgery Through Follow-up (Detailed List in Description Field).|"The occurrence, frequency and nature of abnormalities in any of the following:~physical examination~vital signs~electrocardiography (ECG)~echocardiography (ECHO)~Laboratory tests~Chest X-rays (taken only when clinically indicated)"|From surgery to end of study (2 years).|The study was terminated prematurely. Due to the smaller than planned patient group size no sufficient data was collected for planned analysis of this endpoint.||||||
2649313|NCT01678144|Secondary|Safety: The Occurrence, Nature and Frequency of Device Deficiencies and Adverse Device Effects (ADEs).||From surgery to end of study (2 years).||||Events|||Number
2649314|NCT01678144|Secondary|Safety: The Occurrence, Nature and Frequency of Treatment-emergent Adverse Events (AEs), in Particular Severe Serious Adverse Device Effects (SADEs).|All the adverse events reported were non-device related.|From surgery to end of study (2 years).|Due to the smaller than planned patient group size the descriptive statistics was used. Adverse events data is presented in Adverse Events section.|||Events|||Number
2649315|NCT01678144|Secondary|Safety: The Occurrence, Frequency and Timing of Treatment-emergent Major Adverse Cardiac Events (MACEs).|MACE is defined as stroke and clinically significant myocardial infarction (MI), from surgery to end of study.|From surgery to end of study (2 years)||||Events|||Number
2649316|NCT01678144|Secondary|Safety: 30-day Mortality and Mortality at 3 Months, 6 Months, 1 Year, 1.5 Years and 2 Years.|Mortality rates determined both for all-cause mortality and for related deaths only. For the former, the causality status will be determined by the Investigator, and all deaths that are clearly unrelated to the device, the surgery or the underlying medical condition will be excluded from the analysis.|30 days, 3 months, 6 months, 1 year, 1.5 years and 2 years after surgery||||Participants|||Count of Participants
2649536|NCT01676532|Other Pre-specified|Follow-up Appointments|Attendance at follow-up appoints was not collected.|1 year|||||||
2649317|NCT01678144|Primary|Performance: Percentage of Participants With Improvement by at Least 2 Mitral Regurgitation Classes From Baseline (SC) to Three Months (V03) as Measured by Trans-thoracic Echocardiography (TTE).|Success will be defined as an improvement in at least 2 degrees in mitral regurgitation (MR) class as described in the ACC/AHA Guidelines for the Management of Patients with Valvular Heart Disease (Bonow, et al., 2008).|Time from baseline through V03 (3 months)||||percentage of participants||95% Confidence Interval|Mean
2649318|NCT01678144|Primary|Safety: All-cause Mortality Occurring in the Time From Surgery Through Hospital Discharge.||Time from surgery through hospital discharge, up to 7 days.||||Participants|||Count of Participants
2649319|NCT01678131|Primary|Number of Participants From Whom Detectable Concentrations of Hepatic Vaniprevir Are Obtained by FNA|Liver samples were collected by FNA at 3 of 5 of the following specified postdose timepoints: 3, 12, 24, 48 and 72 hours after a single vaniprevir dose on Day 7. The technical success of the FNA procedure was established for a participant if vaniprevir was detected from at least 2 of the 3 FNA collection timepoints.|Day 7 up to Day 10 at 3 of the following timepoints: 3, 12, 24, 48 and 72 hours postdose|Participants treated with vaniprevir who had hepatic FNA collected at 3 timepoints. One participant from the 300 mg Vaniprevir + Peg-IFN/RBV treatment group, and one participant from the 600 mg Vaniprevir + Peg-IFN/RBV treatment group discontinued treatment prior to collection of 3 FNAs, and were therefore excluded from the analysis.|||Participants|||Number
2649320|NCT01677988|Other Pre-specified|CTC Expression|To determine and evaluate the correlation between expression or biomarkers in the CTCs and expression of biomarkers in resected tissue specimens within the same cancer patient.|2 years|The CTC expression endpoint was added as an amendment. No subjects were enrolled to the study after this amendment was approved, so data for this outcome was not collected or analyzed.||||||
2649321|NCT01677988|Other Pre-specified|CTC Analysis|To evaluate and describe CTC numbers, CTC phenotype characteristics and effectiveness/rate of CTC culturing techniques from patients with pancreatic adenocarcinoma.|End of study|The CTC analysis was added as an amendment. No subjects were enrolled to the study after this amendment was approved, so data for this outcome was not collected or analyzed.||||||
2649322|NCT01677988|Other Pre-specified|Feasibility Objective|The feasibility of treating patients with localized pancreatic head adenocarcinoma with this neoadjuvant regimen will be evaluated by estimating the proportion of patients completing five of six planned doses. The analysis population will be the ITT population.|From enrollment to end of chemotherapy part of the study|The number of subjects who had 5-6 doses of neoadjuvant regimen|||participants|||Number
2649323|NCT01677988|Secondary|Overall Survival:|Overall survival is defined as the time from enrollment to death from any cause. Patients still alive at the end of follow up will have their survival time censored at the last date of contact.|2 years|The study terminated early, prior to the end of the follow up period for all subjects. At the time of study termination, one subject had expired and the time from enrollment to death for that subject is reported below.|||days|||Number
2649324|NCT01677988|Secondary|Time to Recurrence:|Time to recurrence is defined as the time from surgical resection to disease recurrence or death from any cause. Patients who have not recurred at the end of follow up will have their recurrence time censored at the last date of contact.|2 years|The study terminated early, prior to the follow up period being completed. Only one subject had surgery and that subject is still alive at the time of study termination, so time to recurrence cannot be estimated.||||||
2649325|NCT01677988|Secondary|Histopathologic Tumor Response|Estimate the rate of good histopathologic response as the proportion of grade I and II responders. The analysis population for this objective is the ITT population. Any patient for whom a surgical sample is not available will be considered a poor-responder.|at the time of surgery|Only subjects who had surgery were included in this outcome measure.|||grade II responder|||Number
2649326|NCT01677988|Secondary|Radiographic Tumor Response|The rate of CR, PR, SD and PD will be estimated as described in Section 14B prior to chemoradiation start and prior to surgery. The analysis population for estimation of radiographic response rate will be the ITT population.|From enrollment to Surgery|All subjects enrolled and had a response assessment are included in the outcome measure below.|||participants|||Number
2649327|NCT01677988|Primary|Estimate the R0/R1 Resection Rate|Estimate the R0/R1 resection rate as the proportion of patients with R0 or R1 resection status based on the ITT population. R0 resection status is macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor. R1 resection status is macroscopic complete removal of tumor by non-contaminated operation, with microscopic residual tumor.|at time of surgery|Only subjects who had surgery were included in the outcome measure data.|||participants|||Number
2649328|NCT01677936|Secondary|Systolic Blood Pressure|Raisins versus snacks: mmHg change in systolic blood pressure at week 12|12 weeks.||||mmHg||Standard Deviation|Mean
2649329|NCT01677936|Primary|Postprandial Glucose Levels|Raisins versus snacks: percent change in postprandial glucose levels at week 12|12 weeks||||percent||Standard Deviation|Mean
2649330|NCT01677910|Primary|Number of Participants With TEAEs in the Open-Label Extension Period|An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.|First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 54.3 Weeks)|Safety population, defined as all subjects who received at least one dose of study drug was used for analysis.|||Participants|||Count of Participants
2649331|NCT01677910|Secondary|Change From Baseline in Abdominal Pain Averaged Across All Time-Points|Participants recorded abdominal pain in a daily diary. Participants evaluated the level of any abdominal pain using an 11-point numeric rating scale, where: 0=no pain to 10=worst pain ever experienced. The average daily abdominal pain was averaged over the 12-week period. A negative change from Baseline indicates improvement.|Baseline and 12 Weeks|Participants from the Intent-to-treat population, all randomized participants, with available data were included in the analyses.|||units on a scale||Standard Deviation|Mean
2649365|NCT01677507|Secondary|Variation in Episcleral Venous Pressure.|Episcleral venous pressure (mm Hg) of the eye will be determined under baseline condition and under glaucoma drug treatment.|1 week treatment|These measures can be difficult to obtain, so sometimes participants do not tolerate it and some values are missing.|||mmHg||Standard Deviation|Mean
2649332|NCT01677910|Secondary|Change From Baseline in the Number of Daily Cutaneous Flushing Episodes Averaged Across All Time-Points|Participants recorded the number daily flushing episodes per day in a daily diary. The total number of flushing episodes per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.|Baseline and 12 Weeks|Participants from the Intent-to-treat population, all randomized participants, with data available were included in the analyses.|||counts/day||Standard Deviation|Mean
2649333|NCT01677910|Secondary|Change From Baseline in Urinary 5-hydroxyindoleacetic Acid (u5-HIAA) Levels|u5-HIAA is a standard test used in clinical practice to assess neuroendocrine tumor (NET) activity and is collected as a 24-hour urine specimen. A negative change from Baseline indicates improvement.|Baseline and Week 12|Participants from the Intent-to-treat population, all randomized participants, with u5-HIAA data available at Baseline and Week 12 were included in the analyses.|||mg/24 hours||Standard Deviation|Mean
2649334|NCT01677910|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period|An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was an AE reported after the first dose of randomized treatment on Day 1.|First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.6 Weeks)|Safety population, defined as all subjects who received at least one dose of study drug was used for analysis.|||Participants|||Count of Participants
2649335|NCT01677910|Primary|Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks|Participants recorded the number of bowel movements per day in a daily diary. The total number of BMs per day were averaged over the 12-week period. A negative change from Baseline indicates improvement.|Baseline and 12 Weeks|Participants from the Intent-to-treat population, all randomized participants, with data available were included in the analyses.|||counts/day||Standard Deviation|Mean
2649336|NCT01677858|Secondary|Mean Residence Time Observed From Time Zero to Infinity (MRT0-∞) for Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.|||hours||Geometric Coefficient of Variation|Geometric Mean
2649337|NCT01677858|Secondary|Clearance of Carfilzomib After IV Infusion||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.|||liters/hour||Geometric Coefficient of Variation|Geometric Mean
2649338|NCT01677858|Secondary|Terminal Half-life (T1/2,z) for Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.|||hours||Geometric Coefficient of Variation|Geometric Mean
2649339|NCT01677858|Secondary|Volume of Distribution Observed at Steady State (Vss) for Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.|||liters||Geometric Coefficient of Variation|Geometric Mean
2649340|NCT01677858|Secondary|Area Under the Plasma Concentration-time Curve During the Dosing Interval (0-168 Hours) for Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2649341|NCT01677858|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) fo Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2649342|NCT01677858|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2649343|NCT01677858|Secondary|Maximum Plasma Concentration of Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2649537|NCT01676532|Other Pre-specified|Number of Students Referred to SBHC Who Attended SBHC|This data was not collected.|8 months|||||||
2649344|NCT01677858|Secondary|Time to Maximum Plasma Concentration of Carfilzomib||Day 1 cycle 1 (20 mg/m² carfilzomib), cycle 1 day 15 (phase 1 70 and 88 mg/m² carfilzomib), and cycle 2 day 15 (phase 2 70 mg/m² carfilzomib) from predose to 4 hours after the end of the infusion.|Pharmacokinetic (PK) analyses were conducted for participants assigned to cohorts 3 and 4 in phase 1 (70 and 88 mg/m² carfilzomib) and a subset of participants in phase 2; only participants for whom PK parameters could be calculated were included in the analyses.|||hours||Full Range|Median
2649345|NCT01677858|Secondary|Number of Participants With Adverse Events|Adverse events were graded using National Cancer Institute-Common Terminology Criteria for Adverse Events (version 4.03).|From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.|Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).|||Participants|||Count of Participants
2649346|NCT01677858|Secondary|Duration of Response|Duration of response (DOR) was defined as the time from first evidence of PR or better to disease progression or death due to any cause. DOR was calculated using Kaplan-Meier methods; Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.|From randomization until the data cut-off date of 22 July 2016; median follow-up time for DOR was 14.3 months|Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone) with a best overall response of sCR, CR, VGPR, or PR.|||months||95% Confidence Interval|Median
2649347|NCT01677858|Secondary|Time To Progression|Time to progression (TTP) was defined as the time from first dose to disease progression evaluated by the investigator according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). TTP was calculated using Kaplan-Meier methods; participants with no baseline and/or post-baseline disease assessments, who started a new anticancer therapy before documentation of disease progression or death, died or had disease progression immediately after more than 1 consecutively missed disease assessment visit or who were alive without documentation of disease progression before the data cutoff date were censored.|From randomization until the data cut-off date of 22 July 2016; median follow-up time for TTP was 13.4 months|Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).|||months||95% Confidence Interval|Median
2649348|NCT01677858|Secondary|Progression-free Survival|"Progression-free survival (PFS) was defined as the time from first dose to the earlier of disease progression or death due to any cause. The duration of PFS was calculated using Kaplan-Meier methods; participants with no baseline and/or post-baseline disease assessments, who started a new anticancer therapy before documentation of disease progression or death, died or had disease progression immediately after more than 1 consecutively missed disease assessment visit or who were alive without documentation of disease progression before the data cutoff date were censored.~Participants were evaluated for disease response and progression by the investigator according to the IMWG-URC."|From randomization until the data cut-off date of 22 July 2016; median follow-up time for PFS was 13.8 months|Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).|||months||95% Confidence Interval|Median
2649349|NCT01677858|Secondary|Clinical Benefit Response Rate|Clinical benefit rate was defined as the percentage of participants whose best response was sCR, CR, VGPR, PR, or minimal response (MR), where MR is defined by the European Group for Blood and Marrow Transplant (EBMT) criteria as a 25% to 49% reduction in the level of serum M-protein or a 50% to 89% reduction in 24-hour urinary M-protein, which still exceeds 200 mg /24 hour, maintained for a minimum of 8 weeks.|Disease response was assessed once every treatment cycle (28 days) and 30 days after last dose; the median overall treatment duration was 33.6 weeks.|Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).|||percentage of participants||95% Confidence Interval|Number
2649350|NCT01677858|Primary|Overall Response Rate (ORR)|"Disease response was evaluated by the investigator according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). ORR was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).~sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).~CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM.~VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.~PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline."|Disease response was assessed once every treatment cycle (28 days) and 30 days after last dose; the median overall treatment duration was 33.6 weeks.|Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).|||percentage of participants||95% Confidence Interval|Number
2649351|NCT01677858|Primary|Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)|"The MTD was defined as the highest carfilzomib dose at which < 33% of participants had a treatment-related DLT during the first 28-day cycle. A DLT was categorized as nonhematologic or hematologic and defined as follows:~Nonhematologic:~≥ grade 3 nonhematological toxicity (excluding nausea, vomiting, diarrhea, fatigue lasting < 14 days, increased serum creatinine or electrolyte abnormalities not clinically significant or requiring treatment)~≥ grade 3 acute kidney injury (creatinine > 3 x baseline or > 4.0 mg/dL) lasting > 72 hours~≥ grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy~Hematologic:~grade 4 neutropenia (absolute neutrophil count [ANC] < 500/mm³) for > 7 days~febrile neutropenia (ANC < 1000/mm³ with a fever ≥ 38.3ºC) of any duration~grade 4 thrombocytopenia (< 25 000/mm³) for > 14 days, despite holding treatment~grade 3 or 4 thrombocytopenia (< lower limit of normal) associated with > grade 1 bleeding"|28 days|Participants in phase 1 who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).|||participants|||Number
2649366|NCT01677507|Secondary|Variation in Aqueous Flow Between Individuals.|Aqueous flow production (microliters/minute) will be determined under baseline condition and under glaucoma drug treatment.|1 week after treatment|These measurements can be difficult for participants to tolerate, so sometimes values are missing.|||microliters/min||Standard Deviation|Mean
2649352|NCT01677767|Primary|Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.|Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.|Up to Week 24|ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants who had been on other ESAs and had Hb greater than or equal to (≥)10 g/dL at baseline.|||Percentage of participants|||Number
2649353|NCT01677767|Secondary|Number of Participants Received Concomitant Medications|Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported.|Up to Week 24|The safety population included all participants enrolled into the study|||Number of participants|||Number
2649354|NCT01677767|Secondary|Evaluation of Dose Per Injection of C.E.R.A|The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported.|Up to Week 24|The safety population included all participants enrolled into the study|||Microgram||Standard Deviation|Mean
2649355|NCT01677767|Secondary|Evaluation of Route of Administration for C.E.R.A|C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported.|Up to Week 24|The safety population included all participants enrolled into the study|||Number of injections|||Number
2649356|NCT01677767|Secondary|Mean Time Spent by Participants in the Hb Target Range|Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL.|Up to Week 24|ITT population included the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available.|||Week||Standard Deviation|Mean
2649357|NCT01677767|Secondary|Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study|For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.|Up to Week 24|ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available.|||Number of participants|||Number
2649358|NCT01677767|Primary|Percentage of Participants Achieved Target Range of Hemoglobin|The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1. The percentage of participants with Hb < 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.|Up to Week 24|ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants whose Hb value was less than (<) 10 g/dL at enrollment.|||Percentage of participants|||Number
2649359|NCT01677767|Primary|Mean Time Required to Achieve Target Hemoglobin Range|The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1|Up to Week 24|ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants whose Hb value was less than (<) 10 g/dL at enrollment.|||Week||Standard Deviation|Mean
2649360|NCT01677767|Primary|Number of Participants With Co-morbidity Treated With C.E.R.A|Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.|Up to Week 24|The safety population included all participants enrolled into the study.|||Number of participants|||Number
2649361|NCT01677767|Primary|Mean Weight of Participants Treated With C.E.R.A|Weight of the participants was measured at the Baseline and summarized with descriptive statistics.|Baseline (Week 0)|The safety population included all participants enrolled into the study. The analysis population reflects those participants whose weights were assessed at baseline.|||Kilograms||Standard Deviation|Mean
2649362|NCT01677767|Primary|Mean Age of Participants Treated With C.E.R.A|Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25|Baseline (Week 0)|The safety population included all participants enrolled into the study.|||Years||Standard Deviation|Mean
2649363|NCT01677624|Secondary|Success Rate for Operability of Embolization|Operability and usability were evaluated by the Investigator on the basis of the sense of resistance when E7040 was injected, and how smoothly the microspheres could pass through the catheter. The evaluation criteria are very easy to use, easy to use, difficult to use, very difficult to use. Success rate was obtained by calculating the percentage of very easy to use and easy to use cases.|Day 1 (embolization) up to Day 30 after treatment|The analysis was performed using Full Analysis Set defined as all participants who received embolization therapy with E7040 and had at least one evaluable efficacy data after the procedure.|||percentage of participants||95% Confidence Interval|Number
2649364|NCT01677624|Primary|Success Rate of Embolization in the Target Vessel|Embolization performance was graded per 1 of 4 levels: (1) complete embolization, 100% disappearance of contrast enhancement in the target vessel as evaluated by post-embolization digital subtraction angiography; (2) intensive embolization, ≥80% disappearance; (3) moderate embolization, ≥50% and <80% disappearance; (4) mild embolization, <50% disappearance. Success rate was obtained by calculating the percentage of complete embolization and intensive embolization cases. Embolization performance evaluated by both the Imaging Evaluation Committee and by the Investigator or Subinvestigator.|Day 1 (embolization) up to Day 30 after treatment|The analysis was performed using Full Analysis Set defined as all participants who received embolization therapy with E7040 and had at least one evaluable efficacy data after the procedure.|||Percentage of participants||95% Confidence Interval|Number
2649367|NCT01677507|Primary|Variation in Eye Pressure Between Individuals.|Eye pressure is a steady state quantitative trait that is measured in mm Hg. Eye pressure is determined by the following physiological factors (units of measure): eye fluid or aqueous humor production (microliters/minute), aqueous humor outflow (microliters/minute), outflow resistance (microliters/minute/mm Hg) and venous pressure (mm Hg) of the eye. All of these physiological factors will be determined under baseline condition and under glaucoma drug treatment.|Measurement after 1 week of drug treatment||||mmHg||Standard Deviation|Mean
2649368|NCT01677377|Secondary|Participants With Suicidal Ideation or Behavior as Identified Using the Columbia-Suicide Severity Rating Scale (C-SSRS) Score at Baseline and Days 28, 56, 84 and 106|"The C-SSRS is a scale developed by the National Institute of Mental Health trial group as a counterpart to the FDA's categorization of suicidal events. It was developed by a careful review and consequent categorization of thoughts and behavior that were statistically identified as significantly related to suicidal behavior. The scale captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors throughout lifetime at screening, baseline, and for the time interval since last administration for repeat administrations during a study.~This outcome reports the number of participants with suicidal ideation or behavior."|Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)|Safety|||Participants|||Count of Participants
2649369|NCT01677377|Secondary|Global Clinical Assessment of Akathisia Using the Barnes Akathisia Scale (BAS) at Baseline and Days 28, 56, 84 and 106|The BAS is a scale that detects the presence and severity of any drug induced akathisia. The scale measures objective and subjective effects such as restlessness and awareness of restlessness, respectively. Participants are observed while seated, then while standing and engaged in neutral conversation. Symptoms observed during additional situations, such as participant behavior on the ward, may also be rated. Subjective phenomena should be elicited through direct questioning of the participant. The global clinical assessment is reported on a scale of 0 to 5, where 0 = absent and 5 = severe akathisia.|Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)|Safety|||units on a scale||Full Range|Median
2649370|NCT01677377|Secondary|Total Simpson-Angus Scale (SAS) Score at Baseline and Days 28, 56, 84 and 106|The switch from oral risperidone to RBP-7000 subcutaneous injections for safety markers used SAS. The SAS is a 10-item scale used to detect the presence of drug induced parkinsonism and extrapyramidal side effects, and evaluates symptom severity. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0 to 4 scale with 0=normal and 4=extreme description of the particular side effect. The total range is 0=no side effects observed to 40 = extreme of each of the 10 side effects.|Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)|Safety|||units on a scale||Full Range|Median
2649371|NCT01677377|Secondary|Global Assessment of the Abnormal Involuntary Movement Scale (AIMS) for Tardive Dyskinesia at Baseline and Days 28, 56, 84 and 106|"The switch from oral risperidone to RBP-7000 subcutaneous injections for safety markers used AIMS. The AIMS is a scale that aids in the early detection and ongoing monitoring of tardive dyskinesia, a movement disorder that can result from long-term treatment with antipsychotic medication. By assessing the participant's body movement in specific positions requiring rotation, a psychiatrist is able to determine whether abnormal facial or body movements exist.~The total score is the sum of 7 questions assessing movement plus 3 questions representing global assessments on the overall level of involuntary movement severity, incapacitation due to involuntary movement, and patient's awareness of involuntary movement. Each of the 10 questions are scored on a 0 (none) - 4 (extremely severe) scale. Plus two dental status questions are scored on a 0 (no) - 1 (yes) scale. The total score is therefore a scale of 0 (normal) - 42 (advanced tardive dyskinesia)."|Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)|Safety|||units on a scale||Full Range|Median
2649372|NCT01677377|Secondary|Clinical Global Impression (CGI) Scores (Severity of Illness and Global Improvement) at Baseline and Days 28, 56, 84 and 106|"The switch from oral risperidone to RBP-7000 subcutaneous injections for efficacy markers used CGI scores. The CGI is used in the assessment of global illness severity and change in clinical condition over time in psychiatric patients.~Severity of illness is measured on a 7-point scale with 1=normal, not at all ill and 7=among the most extremely ill patients.~Global improvement is measured on a 7-point scale with 1=very much improved, 4=no change and 7=very much worse as compared to the severity of illness at baseline."|Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)|Safety|||units on a scale||Full Range|Median
2649373|NCT01677377|Secondary|Positive and Negative Syndrome Scale (PANSS) Scores at Baseline and Days 28, 56, 84 and 106|"The switch from oral risperidone to RBP-7000 subcutaneous injections for efficacy markers used the PANSS scores. The PANSS assessment is a medical scale designed to measure symptom severity among patients with schizophrenia. Each item is rated on a scale of 1=absent to 7=extreme. PANSS consists of three components:~The General Psychopathology Scale consists of 16 questions with a total range of 16 (no schizophrenia symptoms) to 112 (extreme schizophrenia symptoms).~Both the Positive Scale and the Negative Scale consists of 7 questions with a total range of 7 (no schizophrenia symptoms) to 49 (extreme symptoms) on each scale.~The PANSS range for assuring stability was a total PANSS General Psychopathology Scale score of 70 or less, with no score of 4 on any of the 7 questions in the Positive scale."|Baseline (Day -1), Days 28, 56, 84, and End of Study (Day 106 or early termination visit)|Safety|||units on a scale||Full Range|Median
2649374|NCT01677377|Primary|9-hydroxyrisperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak|"Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29)~Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||hours||Full Range|Median
2649502|NCT01676896|Primary|Number of Asthma Hospital Stays, During Study Year|Number of hospital admissions for asthma. Data were obtained from parent report at the second, third, and fourth data collection point. The number of hospitalizations were summed for a total number at the end of the 12 months.|12 months||||number of hospital stays||Standard Deviation|Mean
2649375|NCT01677377|Primary|9-hydroxyrisperidone PK: Swing Over the Secondary Peak|"The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.~Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29)~Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ratio||Full Range|Median
2649376|NCT01677377|Primary|9-hydroxyrisperidone PK: Percent Fluctuation Over the Secondary Peak|"The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.~Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29)~Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||percentage of average concentration||Full Range|Median
2649377|NCT01677377|Primary|9-hydroxyrisperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak|"Minimum plasma concentrations determined directly from individual concentration-time data.~Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29)~Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649378|NCT01677377|Primary|9-hydroxyrisperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)|"Maximum plasma concentrations determined directly from individual concentration-time data.~Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649379|NCT01677377|Primary|9-hydroxyrisperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)|"The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time~Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29)~Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649380|NCT01677377|Primary|9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)|"Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.~Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29)~Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||hr*ng/mL||Full Range|Median
2649381|NCT01677377|Primary|9-hydroxyrisperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))|"Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ratio||Full Range|Median
2649382|NCT01677377|Primary|9-hydroxyrisperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))|"Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ratio||Full Range|Median
2649503|NCT01676896|Primary|Number of Days in Hospital for Asthma, Pre-Study Year|Number of days hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.|12 months before baseline||||days hospitalized||Standard Deviation|Mean
2649538|NCT01676532|Other Pre-specified|Number of Students Triaged From School Support Team Meetings|The number of students triaged from SST meetings was not collected.|1 year|||||||
2649383|NCT01677377|Primary|9-hydroxyrisperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile|"Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||hours||Full Range|Median
2649384|NCT01677377|Primary|9-hydroxyrisperidone PK: Swing Over the PK Profile|"The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.~Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ratio||Full Range|Median
2649385|NCT01677377|Primary|9-hydroxyrisperidone PK: Percent Fluctuation Over the PK Profile|"The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.~Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||percentage of average concentration||Full Range|Median
2649386|NCT01677377|Primary|9-hydroxyrisperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile|"Minimum plasma concentrations determined directly from individual concentration-time data.~Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649387|NCT01677377|Primary|9-hydroxyrisperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile|"Maximum plasma concentrations determined directly from individual concentration-time data.~Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649388|NCT01677377|Primary|9-hydroxyrisperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile|"The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)~Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649389|NCT01677377|Primary|9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)|"AUCtau calculated using the linear trapezoidal rule.~Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||hr*ng/mL||Full Range|Median
2649390|NCT01677377|Primary|9-hydroxyrisperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak|"Tmax determined directly from individual concentration-time data.~Results are reported across two timeframes:~Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)~Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-2, Day 57-58|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||hours||Full Range|Median
2649523|NCT01676714|Primary|Overall Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 100 months||||Participants|||Count of Participants
2649391|NCT01677377|Primary|9-hydroxyrisperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak|"Cmax determined directly from individual concentration-time data.~Results are reported across two timeframes:~Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)~Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-2, Day 57-58|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649392|NCT01677377|Primary|9-hydroxyrisperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)|"AUC0-24 calculated using the linear trapezoidal rule.~Results are reported across two timeframes:~Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)~Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-2, Day 57-58|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||hr*ng/mL||Full Range|Median
2649393|NCT01677377|Primary|Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak|"Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29)~Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||hours||Full Range|Median
2649394|NCT01677377|Primary|Risperidone PK: Swing Over the Secondary Peak|"The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.~Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29)~Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ratio||Full Range|Median
2649395|NCT01677377|Primary|Risperidone PK: Percent Fluctuation Over the Secondary Peak|"The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.~Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29)~Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||percentage of average concentration||Full Range|Median
2649396|NCT01677377|Primary|Risperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak|"Minimum plasma concentrations determined directly from individual concentration-time data.~Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29)~Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649397|NCT01677377|Primary|Risperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)|"Maximum plasma concentrations determined directly from individual concentration-time data.~Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649398|NCT01677377|Primary|Risperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)|"The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time~Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29)~Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649507|NCT01676896|Secondary|Medication Adherence, Time 4|Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at final data point, Time 4.|Time 4 at 12 months||||number of yes responses||Standard Deviation|Mean
2649399|NCT01677377|Primary|Risperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)|"Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.~Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29)~Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||hr*ng/mL||Full Range|Median
2649400|NCT01677377|Primary|Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))|"Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ratio||Full Range|Median
2649401|NCT01677377|Primary|Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))|"Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ratio||Full Range|Median
2649402|NCT01677377|Primary|Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile|"Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||hours||Full Range|Median
2649403|NCT01677377|Primary|Risperidone PK: Swing Over the PK Profile|"The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.~Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ratio||Full Range|Median
2649404|NCT01677377|Primary|Risperidone PK: Percent Fluctuation Over the PK Profile|"The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.~Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||percentage of average concentration||Full Range|Median
2649405|NCT01677377|Primary|Risperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile|"Minimum plasma concentrations determined directly from individual concentration-time data.~Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649406|NCT01677377|Primary|Risperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile|"Maximum plasma concentrations determined directly from individual concentration-time data.~Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649504|NCT01676896|Primary|Absenteeism Pre-study Year|(Days absent/days enrolled)x100 = absenteeism. Using data for the 12 months prior to study enrollment as the pre-study year. Data is provided by the participating school districts.|12 months before baseline|Data for days enrolled and days absent for the pre-study year was obtained from the school districts. Two school districts declined to provide the requested information, therefore there was substantial missing data for this variable.|||percentage of days enrolled||Standard Deviation|Mean
2649407|NCT01677377|Primary|Risperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile|"The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)~Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649408|NCT01677377|Primary|Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)|"AUCtau calculated using the linear trapezoidal rule.~Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||hr*ng/mL||Full Range|Median
2649409|NCT01677377|Primary|Risperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak|"Tmax determined directly from individual concentration-time data.~Results are reported across two timeframes:~Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)~Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-2, Day 57-58|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||hours||Full Range|Median
2649410|NCT01677377|Primary|Risperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak|"Cmax determined directly from individual concentration-time data.~Results are reported across two timeframes:~Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)~Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-2, Day 57-58|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649411|NCT01677377|Primary|Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)|"AUC0-24 calculated using the linear trapezoidal rule.~Results are reported across two timeframes:~Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)~Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-2, Day 57-58|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||hr*ng/mL||Full Range|Median
2649412|NCT01677377|Primary|Total Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the Secondary Peak|"Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:~[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]~Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29)~Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||hours||Full Range|Median
2649413|NCT01677377|Primary|Total Risperidone PK: Swing Over the Secondary Peak|"Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:~[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]~The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.~Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29)~Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ratio||Full Range|Median
2649505|NCT01676896|Primary|Number of Asthma Hospitalizations Pre-Study Year|Number of times hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.|12 months before baseline||||number of hospitalizations||Standard Deviation|Mean
2649506|NCT01676896|Other Pre-specified|Lung Inflammation, Time 4|Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 4 visit. Higher values represent greater airway inflammation.|Time 4 at 12 months||||uM||Standard Deviation|Mean
2649414|NCT01677377|Primary|Total Risperidone PK: Percent Fluctuation Over the Secondary Peak|"Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:~[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]~The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.~Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29)~Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||percentage of average concentration||Full Range|Median
2649415|NCT01677377|Primary|Total Risperidone PK: Minimum Plasma Concentration (Cmin) Over the Secondary Peak|"Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:~[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]~Minimum plasma concentrations determined directly from individual concentration-time data.~Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29)~Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649416|NCT01677377|Primary|Total Risperidone PK: Maximum Plasma Concentration Over the Secondary Peak (Cmax)|"Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:~[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]~Maximum plasma concentrations determined directly from individual concentration-time data.~Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29) Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649417|NCT01677377|Primary|Total Risperidone PK: Average Plasma Concentration Over the Secondary Peak (Cavg, Day 2-29)|"Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:~[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]~The average of plasma concentrations in the plateau, calculated as AUC Day 2-29/time~Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29)~Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649418|NCT01677377|Primary|Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Day 2-29 Post Injection (AUC Day 2-29)|"Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:~[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]~Area under plasma concentration-time curve from 24 hours (Day 2) to the last quantifiable collection during dosing interval (28 days); calculated using the linear trapezoidal rule.~Results are reported across two timeframes:~Secondary Peak, Injection 1 (Day 2 - Day 29)~Secondary Peak, Injection 3 (Day 58 - Day 85)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 at time of study drug administration."|Day 2-29, Day 58-85|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||hr*ng/mL||Full Range|Median
2649445|NCT01677182|Secondary|Percentage of Participants With MADRS Remission|MADRS remission is defined as a MADRS total score less than or equal to (<=) 10. The MADRS is a clinician rated, validated and widely used scale to measure overall severity of depressive symptoms. It consists of 10-item rated from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60, where higher scores indicate greater severity of symptoms.|Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy. LOCF method was used to impute missing data.|||percentage of participants|||Number
2649524|NCT01676701|Secondary|Change From Baseline Score in Subcutaneous Administration Assessment Questionnaire (SQAAQ)||Baseline, Weeks 4 and 8|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
2649419|NCT01677377|Primary|Total Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Maximum Plasma Concentrations (Rac(Cmax))|"Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:~[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]~Accumulation index in terms of Cmax calculated as ratio of Cmax injection 3 / injection 1.~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ratio||Full Range|Median
2649420|NCT01677377|Primary|Total Risperidone PK: Accumulation Index Between Injections 1 and 3 In Terms of Area Under the Plasma Concentration Curve (Rac(AUC))|"Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:~[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]~Accumulation index in terms of AUC calculated as ratio of AUCtau injection 3 / injection 1. Tau = 28 days.~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ratio||Full Range|Median
2649421|NCT01677377|Primary|Total Risperidone PK: Time of the Maximum Plasma Concentration (Tmax) Over the PK Profile|"Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:~[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]~Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||hours||Full Range|Median
2649422|NCT01677377|Primary|Total Risperidone PK: Swing Over the PK Profile|"Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:~[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]~The swing of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cmin.~Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ratio||Full Range|Median
2649423|NCT01677377|Primary|Total Risperidone PK: Percent Fluctuation Over the PK Profile|"Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:~[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]~The degree of fluctuation of total risperidone plasma concentrations calculated as (Cmax - Cmin) / Cavg, expressed as a percentage.~Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||percentage of average concentration||Full Range|Median
2649424|NCT01677377|Primary|Total Risperidone PK: Minimum Plasma Concentration (Cmin) Over the PK Profile|"Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:~[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]~Minimum plasma concentrations determined directly from individual concentration-time data.~Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649425|NCT01677377|Primary|Total Risperidone PK: Maximum Plasma Concentration (Cmax) Over the PK Profile|"Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:~[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]~Maximum plasma concentrations determined directly from individual concentration-time data.~Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649426|NCT01677377|Primary|Total Risperidone PK: Average Plasma Concentration (Cavg) Over the PK Profile|"Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:~[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]~The average of plasma concentrations calculated as AUCtau/ tau (tau = 28 days)~Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649427|NCT01677377|Primary|Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Time Tau (Where Tau=28 Days) (AUCtau)|"Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:~[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]~AUCtau calculated using the linear trapezoidal rule.~Results are reported across two timeframes:~Overall, Injection 1 (Day 1 injection to Day 28)~Overall, Injection 3 (Day 57 injection to Day 84)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-28, Day 57-84|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||hr*ng/mL||Full Range|Median
2649428|NCT01677377|Primary|Total Risperidone PK: Time of Maximum Plasma Concentration (Tmax) During Initial Peak|"Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:~[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]~Tmax determined directly from individual concentration-time data.~Results are reported across two timeframes:~Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)~Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-2, Day 57-58|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||hours||Full Range|Median
2649429|NCT01677377|Primary|Total Risperidone PK: Maximum Plasma Concentration (Cmax) During Initial Peak|"Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:~[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]~Cmax determined directly from individual concentration-time data.~Results are reported across two timeframes:~Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)~Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-2, Day 57-58|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||ng/mL||Full Range|Median
2649446|NCT01677182|Secondary|Percentage of Participants With MADRS Response|MADRS response is defined as greater than or equal to (>=) 50 percent (%) decrease in the MADRS total score from baseline. The MADRS is a clinician rated, validated and widely used scale to measure overall severity of depressive symptoms. It consists of 10-item rated from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60, where higher scores indicate greater severity of symptoms.|Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy. Last observation carried forward (LOCF) method was used to impute missing data.|||percentage of participants|||Number
2649525|NCT01676701|Secondary|Number of Operation Failures||Week 12|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
2649430|NCT01677377|Primary|Total Risperidone PK: Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24)|"Total risperidone concentration (risperidone and 9-hydroxyrisperidone) was determined by adding risperidone concentration to risperidone-equivalent concentration (obtained from the 9-hydroxyrisperidone data). Total risperidone concentration was calculated using the molecular weights of 410 for risperidone and 426 for 9-hydroxyrisperidone:~[Total Risperidone] = [Risperidone] + (410/426) * [9-hydroxyrisperidone]~AUC0-24 calculated using the linear trapezoidal rule.~Results are reported across two timeframes:~Initial Peak, Injection 1 (Day 1 injection to 24 hours after injection)~Initial Peak, Injection 3 (Day 57 injection to 24 hours after injection)~The PK sampling schedule was:~Days 1 and 57: within 15 minutes prior to dosing, and at 1, 2, 3, 4, 6, and 12 hours post-dose~Days 2, 4, 6, 8-12, 15, 18, 22, 25, 58, 60, 62, 64-68, 71, 74, 78, 81 once each day at same time of day as study drug administration"|Day 1-2, Day 57-58|The PK analysis population was defined as all participants who received an injection of RBP-7000 and had an adequate number of PK blood draws (as determined by a clinical pharmacologist/pharmacokineticist) in order to provide a meaningful analysis of PK parameters.|||hr*ng/mL||Full Range|Median
2649431|NCT01677377|Primary|Summary of Participants With Treatment-Emergent Adverse Events (TEAE)|"An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date. AEs are determined by the Investigator to be related or not related to the study drug.~A serious AE (SAE) is defined by federal regulation as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Although a subject may have had 2 or more adverse experiences the subject is counted only once in a category. The same subject may appear in different categories."|Day 1 to Day 106|Safety population|||Participants|||Count of Participants
2649432|NCT01677312|Secondary|Complications|The safety profile of the 19 and 25G needles will be compared that includes bleeding, pancreatitis and perforation.|30 days||||percentage of participants|||Number
2649433|NCT01677312|Secondary|Needle Dysfunction|The percentage of cases in which needle dysfunction occurs will be compared between the 19G and 25G needle types. Needle dysfunction will be defined as the need to use more than one FNA needle per lesion in an individual patient.|2 hours||||percentage of participants|||Number
2649434|NCT01677312|Secondary|Procurement of Histological Samples|The ability of the 19G and 25G needles to obtain core (histological) tissue will be compared and a significance will be determined.|30 days||||percentage of participants|||Number
2649435|NCT01677312|Primary|Median Number of Passes to Establish Diagnosis|To compare the median number of passes required to establish diagnosis using the 19G and 25G needles for FNA of solid pancreatic mass lesions. This will be measured by comparing the rates of diagnostic accuracy (%) between both needle types.|5 months||||No. of passes||Inter-Quartile Range|Median
2649436|NCT01677299|Primary|Within Treatment Comparison Based on Ratios of AUCs of PYY||Ratio of Day 5 to Baseline|Evaluable Population|||none (values are ratios)||Standard Error|Least Squares Mean
2649437|NCT01677299|Primary|Within Treatment Comparison Based on Ratios of AUCs of GLP-1||Ratio of Day 5 to Baseline|Evaluable|||none (values are ratios)||Standard Error|Least Squares Mean
2649438|NCT01677299|Primary|Change in Fasting Plasma Glucose|LS mean difference from Baseline (Day 1) to Day 5|Change from Baseline (Day 1) to Day 5|Evaluable Population|||mg/dL||Standard Error|Least Squares Mean
2649439|NCT01677299|Primary|Area Under the Curve (0-t) of Plasma Metformin|Measures from the time of dosing (0 h) to the time of the last quantifiable concentration following dose administration. The dose of study medication was administered at t = -1 min relative to the start time of the standardized breakfast.|Time points at which data were collected to create the area under the curve (0-t) for plasma metformin were: t = -0.08, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 11 h relative to the start time of the standardized breakfast.|Evaluable Population|||ng*h/mL||Standard Deviation|Mean
2649440|NCT01677286|Primary|Amyloid Nephropathy: Proteinuria|Patients with predominant amyloid kidney involvement at enrollment.|Data were assessed at baseline, 6 and 12 months, with change at end of study reported|Analysis is limited to the patients with predominant amyloid kidney involvement at enrollment. Mixed models analyses of change from baseline levels of creatinine clearance (ml/min) and proteinuria (g/day) were performed to include all data collected at baseline, 6 and 12 months.|||g/day||Standard Deviation|Mean
2649441|NCT01677286|Primary|Amyloid Nephropathy: Creatinine Clearance|Creatinine clearance (ml/min) and proteinuria (g/day) were assessed at baseline, 6 and 12 months, with change at change at end of study reported|12 months|Analysis is limited to the patients with predominant amyloid kidney involvement at enrollment. Mixed models analyses of change from baseline levels of creatinine clearance (ml/min) and proteinuria (g/day) were performed to include all collected data.|||ml/min||Standard Deviation|Mean
2649442|NCT01677286|Primary|Amyloid Cardiomyopathy: Troponin I|Cardiac biomarkers (BNP, Troponin I) were assessed at baseline, 6 and 12 months, with change at change at end of study reported|12 months|Patients with predominant amyloid involvement of the heart.|||ng/mL||Standard Deviation|Mean
2649443|NCT01677286|Primary|Amyloid Cardiomyopathy: BNP|Cardiac biomarkers (BNP, Troponin I) were assessed at baseline, 6 and 12 months, with change at end of study reported|12 months|Analysis is limited to the patients with predominant amyloid heart involvement at enrollment. Mixed models analyses of change from baseline levels of cardiac biomarkers (BNP, Troponin I) were performed to include all collected data.|||pg/mL||Standard Deviation|Mean
2649444|NCT01677195|Primary|AFB1-lysine Adduct (pg/mg) Overtime|After randomization, participants provided serum samples at baseline, weeks 4, 12, and 16. Week 16 represents one month off treatment.|3 months on intervention (weeks 0-12); 1 month off intervention (week 16)||||pg/mg albumin||Standard Deviation|Mean
2649498|NCT01676896|Secondary|Asthma Self-management, Time 2|Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 2 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.|Time 2 at 5 months||||units on a scale||Standard Deviation|Mean
2649447|NCT01677182|Secondary|Change From Baseline in Quality of Life, Enjoyment, and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Total Score at Week 6|Q-LES-Q-SF is a self-administered, widely used 16-item questionnaire to assess the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning, such as social relationships, living/housing, physical health, medication, and global satisfaction. The questionnaire consists of 16 items rated by the participants on a 5-point scale. Of these, 14 items are summed to produce a total quality of life score with a maximum of 70 points. In addition, there are 2 global items that are scored individually. These items rate satisfaction with study medication and overall life satisfaction. The questionnaire is usually scored as a percent of the total possible score, with higher scores indicating better health status.|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.|||percentage of total possible score||Standard Error|Least Squares Mean
2649448|NCT01677182|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 6|The SDS is a 3-item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over 3 inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11-point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30 where higher scores indicates greater severity of impairment.|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.|||units on a scale||Standard Error|Least Squares Mean
2649449|NCT01677182|Secondary|Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self-Rated16 (QIDS-SR16) Total Score at Week 6|The 16-item QIDS-SR16 version is a widely used validated scale designed to assess the severity of depressive symptoms. The participant was asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27, where higher scores indicate higher severity of symptoms.|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.|||units on a scale||Standard Error|Least Squares Mean
2649450|NCT01677182|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) to Week 6|"The CGI-S assesses the clinician's impression of the participant's current state of mental illness and consists of 1 question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a 7-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill)."|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.|||units on a scale||Standard Error|Least Squares Mean
2649451|NCT01677182|Secondary|Clinical Global Impression Scale-Improvement (CGI-I) Score|"The CGI-I assesses the clinician's impression of the participant's state of mental illness improvement and consists of 1 question for the investigator: Compared to his condition at the start of the study, how much has this patient changed? which is rated on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change relative to baseline; 5=minimally worse; 6= much worse; 7=very much worse). In all cases, the assessment was independent of whether the rater believed the improvement was drug-related or not."|Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.|||units on a scale||Standard Error|Least Squares Mean
2649452|NCT01677182|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 6|The YMRS is a 11-item scale to assess manic symptoms. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), and 7 items are rated on a scale from 0 to 4 with higher scores reflecting greater levels of mania. The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60.|Baseline and Week 6|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.|||units on a scale||Standard Error|Least Squares Mean
2649453|NCT01677182|Primary|Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6|The MADRS is a clinician rated, validated and widely used scale to measure overall severity of depressive symptoms. It consists of 10-item rated from 0(normal) to 6(most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Baseline and Week 6|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline value and at least 1 valid post-baseline value for assessment of primary efficacy.|||units on scale||Standard Error|Least Squares Mean
2649454|NCT01676961|Secondary|Percentage of Patients Who Experienced Thrombosis or Marrow Fibrosis||Up to 1.5 years|Patient data was not analyzefd||||||
2649455|NCT01676961|Primary|Percentage of Patients Who Have Responded|Response is defined as platelet increases to greater than 50 x 10^9/L for more than 2 weeks.|8 weeks|Data was not analyzed. Dr. Mazumder left institution and data was not analyzed.||||||
2649456|NCT01676909|Other Pre-specified|Maryland Assessment of Recovery Scale (MARS)|The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale of not at all (1) to very much (5). Combined scores may range from 25-125, higher scores indicate greater self-reported recovery. The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868)|Baseline, Post-Invention (3 months after baseline), Follow-up (6 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649499|NCT01676896|Secondary|Asthma Self-management, Time 3|Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 3 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.|Time 3 at 9 months||||units on a scale||Standard Deviation|Mean
2649526|NCT01676701|Secondary|Number of Participants Developing Anti-Tabalumab Antibodies||Week 12|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
2649457|NCT01676909|Other Pre-specified|Multidimensional Health Locus of Control (HLOC)|Measured with a subscale of the Multidimensional Health Locus of Control. Possible scores range from 0 to 36, with higher scores indicating greater internal locus of control. An 18 item questionnaire with responses ranging on a 6 point Likert scale from Strongly Disagree to Strongly Agree that asks about self-perceived control over one's health, illnesses, and ability to take an active role in one's health.|Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649458|NCT01676909|Other Pre-specified|Morisky Medication Adherence Scale|Possible scores range from 0 to 16, with higher scores indicating greater adherence. The distribution was skewed so a square root transformation was applied before analysis.|Baseline, Follow-up (6 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649459|NCT01676909|Other Pre-specified|Maryland Assessment of Recovery Scale (MARS)|The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale ranging from not at all (1) to very much (5). The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868). Combined scores may range from 25-125, higher scores indicate greater self-reported recovery.|Baseline, Post-intervention (3 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649460|NCT01676909|Other Pre-specified|Multidimensional Health Locus of Control (HLOC)|Measured with a subscale of the Multidimensional Health Locus of Control. Possible scores range from 0 to 36, with higher scores indicating greater internal locus of control. An 18 item questionnaire with responses ranging on a 6 point Likert scale from Strongly Disagree to Strongly Agree that asks about self-perceived control over one's health, illnesses, and ability to take an active role in one's health.|Baseline, Post-intervention (3 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649461|NCT01676909|Other Pre-specified|Morisky Medication Adherence Scale|This 4 item self-reported medication adherence scale was developed from a well validated 8-item scale with responses ranging from Never (0) to Very Often (4) to to better capture barriers surrounding adherence behavior. This new scale has demonstrated psychometric properties. Possible scores range from 0 to 16, with higher scores indicating greater adherence. The distribution was skewed so a square root transformation was applied before analysis.|Baseline, Post-intervention (3 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649462|NCT01676909|Secondary|Measure of Self-Management Behaviors - Healthy Eating Subscale|This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5).Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.|Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649463|NCT01676909|Secondary|Measure of Self-Management Behaviors - Physical Activity Subscale|This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management.|Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649464|NCT01676909|Secondary|Measure of Self-Management Behaviors - Accessing Social Support Subscale|This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.|Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649465|NCT01676909|Secondary|Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale|This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Scores may range from 0-30 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.|Baseline, Post-Intervention, Follow-up (6 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649527|NCT01676701|Secondary|Percentage of Participants Achieving European League Against Rheumatism Responder Index Based on the 28-Joint Count (EULAR-28)||Week 12|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
2649466|NCT01676909|Secondary|Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale|This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5). Scores may range from 0-20 on this subscale, higher scores indicate greater frequency of behavior indicating greater self-management behavior.|Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649467|NCT01676909|Secondary|Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale|This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of the behavior indicating greater self-management behavior.|Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649468|NCT01676909|Secondary|Patient Activation Measure|This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity|Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649469|NCT01676909|Secondary|Illness Management Self-Efficacy|This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater self-efficacy.|Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649470|NCT01676909|Secondary|Short-Form 12 (SF-12) Mental Scale (Norm Based)|12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.|Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649471|NCT01676909|Secondary|Short-Form 12 (SF-12) Physical Scale (Norm Based)|12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.|Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649472|NCT01676909|Secondary|Short Form-12 (SF-12) General Health (Norm Based)|12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.|Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649473|NCT01676909|Secondary|Measure of Self-Management Behaviors - Healthy Eating Subscale|This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.|Baseline, Post-intervention (3 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649500|NCT01676896|Primary|Quality of Life, Pre-study Year|Self reported asthma-related quality of life. Data were collected at study enrollment (time 1). The Pediatric Asthma Quality of Life scale. Minimum score 23 to maximum score of 115. A higher score indicates worse quality of life. Mean scale scores are computed.|12 months before baseline||||units on a scale||Standard Deviation|Mean
2649474|NCT01676909|Secondary|Measure of Self-Management Behaviors - Physical Activity Subscale|This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.|Baseline, Post-intervention (3 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649475|NCT01676909|Secondary|Measure of Self-Management Behaviors - Accessing Social Support Subscale|This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.|Baseline, Post-intervention (3 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649476|NCT01676909|Secondary|Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale|This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Combined scores from these 4 items may range from 0-30 on this subscale, higher scores indicating greater frequency or using the behavior indicating greater self-management.|Baseline, Post-intervention (3 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649477|NCT01676909|Secondary|Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale|This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5).Combined scores from these 4 items may range from 0-20 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.|Baseline, Post-intervention (3 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649478|NCT01676909|Secondary|Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale|This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.|Baseline, Post-intervention (3 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649479|NCT01676909|Secondary|Patient Activation Measure|This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity.|Baseline, Post-intervention (3 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649480|NCT01676909|Secondary|Illness Management Self-Efficacy|This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency.|Baseline, Post-intervention (3 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649481|NCT01676909|Primary|ER Visit Between Baseline and the 6-month Follow-up|Emergency Room Visit during the approximate 6-month period between baseline and the follow-up visit.|Baseline, Follow-up (6-months after baseline)||||Participants|||Count of Participants
2649482|NCT01676909|Primary|Short-Form 12 (SF-12) Mental Scale (Norm Based)|12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.|Baseline, Post-intervention (3 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649483|NCT01676909|Primary|Short-Form 12 (SF-12) Physical Scale (Norm Based)|12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.|Baseline, Post-intervention (3 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649484|NCT01676909|Primary|Short Form-12 (SF-12) General Health (Norm Based)|12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.|Baseline, Post-intervention (3 months after baseline)|Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.|||units on a scale||Standard Deviation|Mean
2649485|NCT01676896|Other Pre-specified|Lung Inflammation, Time 3|Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 3 visit. Higher values represent greater airway inflammation.|Time 3 at 9 months||||uM||Standard Deviation|Mean
2649486|NCT01676896|Other Pre-specified|Lung Inflammation, Time 2|Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 2 visit. Higher values represent greater airway inflammation.|Time 2 at 5 months||||uM||Standard Deviation|Mean
2649487|NCT01676896|Other Pre-specified|Lung Inflammation, Time 1|Exhaled breath condensation collected and sent for lab analysis of NO3. Data collected at Time 1 visit. Higher values represent greater airway inflammation.|Time 1 at baseline||||uM||Standard Deviation|Mean
2649488|NCT01676896|Secondary|Medication Adherence, Time 3|Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at Time 3 visit.|Time 3 at 9 months||||number of yes responses||Standard Deviation|Mean
2649489|NCT01676896|Secondary|Medication Adherence, Time 2|Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at Time 2 visit.|Time 2 at 5 months||||number of yes responses||Standard Deviation|Mean
2649490|NCT01676896|Secondary|Medication Adherence, Time 1|Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at study enrollment, Time 1.|Time 1 at baseline||||number of yes responses||Standard Deviation|Mean
2649491|NCT01676896|Secondary|Metered Dose Inhaler Skill, Time 1|Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at enrollment visit, Time 1 data visit.|Time 1 at baseline||||number of correct steps||Standard Deviation|Mean
2649492|NCT01676896|Secondary|Metered Dose Inhaler Skill, Time 2|Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at final, time 2 data visit.|Time 2 at 5 months||||number of correct steps||Standard Deviation|Mean
2649493|NCT01676896|Secondary|Metered Dose Inhaler Skill, Time 3|Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at time 3 data visit.|Time 3 at 9 months||||number of correct steps||Standard Deviation|Mean
2649494|NCT01676896|Secondary|Home Asthma Management, Time 3|Parent report of asthma preventive and treatment activities. Data collected at third time point (Time 3). Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.|Time 3 at 9 months||||units on a scale||Standard Deviation|Mean
2649495|NCT01676896|Secondary|Home Asthma Management, Time 2.|Parent report of asthma preventive and treatment activities. Data collected at the time 2 visit. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.|Time 2 at 5 months||||units on a scale||Standard Deviation|Mean
2649496|NCT01676896|Secondary|Home Asthma Management, Time 1, Baseline|Parent report of asthma preventive and treatment activities. Data are collected at study enrollment, Time 1, baseline visit. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.|Time 1, baseline||||units on a scale||Standard Deviation|Mean
2649497|NCT01676896|Secondary|Asthma Self-management, Time 1, Baseline|Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the baseline, Time 1 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.|Time 1, baseline||||units on a scale||Standard Deviation|Mean
2649501|NCT01676896|Primary|Emergency Department Visits, Pre-study Year|Number of visits to Emergency Department for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.|12 months before baseline||||number of visits||Standard Deviation|Mean
2649508|NCT01676896|Secondary|Metered Dose Inhaler Skill, Time 4|Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at final, time 4 data visit.|Time 4 at 12 months||||number of correct steps||Standard Deviation|Mean
2649509|NCT01676896|Secondary|Home Asthma Management, Time 4, End of Study|Parent report of asthma preventive and treatment activities. Data collected at final study visit, Time 4. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.|Time 4 at 12 months||||units on a scale||Standard Deviation|Mean
2649510|NCT01676896|Secondary|Asthma Self-management, Time 4|Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 4, final measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.|Time 4, at 12 months||||units on a scale||Standard Deviation|Mean
2649511|NCT01676896|Primary|Emergency Department Visits, Study Year|Number of visits to Emergency Department for asthma. Data is obtained from parents at three time points (time 2, 3, and 4) and summed for total number of visits to the emergency department for asthma during the study year.|12 months||||number of visits||Standard Deviation|Mean
2649512|NCT01676896|Primary|Number of Days Hospitalized, During Study Year|Number of days hospitalized for asthma. Data were obtained from parent report at the second, third, and fourth data collection point. The number of hospitalization days were summed for a total number at the end of the 12 months.|12 months||||days hospitalized||Standard Deviation|Mean
2649513|NCT01676896|Primary|Quality of Life, End of Study|Self reported asthma-related quality of life. Outcome data were collected at end of study (Time 4). The Pediatric Asthma Quality of Life scale. Minimum score 23 to maximum score of 115. A higher score indicates worse quality of life. Mean scale scores are computed.|12 months||||units on a scale||Standard Deviation|Mean
2649514|NCT01676896|Primary|Absenteeism, End of Study|(Days absent/days enrolled)x100 = absenteeism. Using data provided by the school district at the end of the study year.|12 months|Data for days enrolled and days absent was obtained from the school districts. Two school districts declined to provide the requested information, therefore there was substantial missing data for this variable.|||percentage of days enrolled||Standard Deviation|Mean
2649515|NCT01676831|Secondary|Secondary End Points: Efficacy- SWAT SCORE|"The secondary endpoint is:~The total surface area of involvement will also be assessed (SWAT score). A partial response will represent improvement in 50% or greater of the skin surface area with regression of lesions. A complete response will represent complete clear clearing of skin lesions and in the case of stage IIA patients, resolution of lymphadenopathy. The outcome measure will indicate how many received complete response (CR), partial response (PR), and stable disease (SD)."|Up to 24 weeks or At the conclusion of patient therapy||||Participants|||Count of Participants
2649516|NCT01676831|Secondary|Secondary End Points: Efficacy- CAILDS SCORE|"The secondary endpoint is:~• The Response Rate (Complete or Partial Response) based on Composite Assessment of Index Lesions Disease Severity (CAILDS) score at EOS for the baseline target lesions. Complete Response is defined as a score of '0' on the CAILDS scale. Partial response is defined as a reduction of at least 50% in the CAILDS. The outcome measure will indicate how many received complete response (CR), partial response (PR), and stable disease (SD)."|Up to 24 weeks or At the conclusion of patient therapy||||Participants|||Count of Participants
2649517|NCT01676831|Primary|The Number of Participants That Tolerated the Maximum Drug Dose|"After four subjects have completed at least four weeks of study drug dosing a safety review meeting will be conducted by a safety review committee. No subjects will be enrolled in the next concentration (0.03%)group until all eight have been evaluated in the 0.06% group.~The safety review committee reviews all patient data including adverse events to indicate whether the patient can escalate to the highest dose."|after 4 subjects have completed 4 weeks of study drug||||Participants|||Count of Participants
2649518|NCT01676727|Secondary|Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)|"The combined safety endpoint is defined as a composite of:~All-cause mortality~All stroke~Life-threatening bleeding~Acute kidney injury-Stage 3 (including renal replacement therapy)~Coronary artery obstruction requiring intervention~Major vascular complication~Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)~High degree AV block requiring permanent pacemaker implantation"|1, 6 and 12 months|all subjects who underwent an attempted implant of whom all were implanted with the CoreValve device via the direct aortic approach|||Percentage of subjects||95% Confidence Interval|Number
2649519|NCT01676727|Primary|All-cause Mortality|Kaplan-Meier estimate of 30-day all-cause mortality.|30 days post-implant|all subjects who underwent an attempted implant of whom all were implanted with the CoreValve device via the direct aortic approach|||Percentage of subjects||95% Confidence Interval|Number
2649520|NCT01676714|Secondary|Number of Patients Who Experienced Treatment Related Toxicities|Toxicities will be summarized by the type, severity (by NCI CTCAE), time of onset, duration, and outcome. Toxicity will be graded according to the NCI CTCAE version 4.0.|Starting at screening and then at every visit and then up to 30 days after the last dose of study treatment.||||Participants|||Count of Participants
2649521|NCT01676714|Secondary|Progression Free Survival|The length of time during and after the treatment of the cancer that a patient lives with the disease but it does not get worse. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From start of treatment until the date of death from any cause, assessed up to 100 months||||months||Full Range|Median
2649522|NCT01676714|Secondary|Disease Control Rate|The total number of patients who demonstrate a response to treatment. Measured by RECIST 1.1 criteria.|From start of treatment, up to 8 weeks|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until progression or unacceptable toxicity develops.|||participants|||Number
2649528|NCT01676701|Secondary|Change From Baseline to 12-Week Endpoint in Disease Activity Score Based on a 28-Joint Count and C-Reactive Protein (DAS28-CRP) Level||Baseline, Week 12|No participant had outcome measure data analyzed due to the termination of the trial and an insufficient sample size.||||||
2649539|NCT01676532|Other Pre-specified|Sprucecourt Public School Vs Other Participating Schools|To compare the number of students who attend the SBHC from the host school (Sprucecourt Public School) with the number of students who attend the SBHC from the other participating schools|8 months|total number of students who attended SBHC|||participants|||Number
2649540|NCT01676532|Other Pre-specified|Number of Students Enrolled in SBHC Who Were From the Host School (Sprucecourt)|The number of students who enrolled in SBHC who were from the host school Sprucecourt|8 months|Total number of students who enrolled in SBHC. Outcome is the number of students from host school (sprucecourt) who enrolled in SBHC|||participants|||Number
2649541|NCT01676532|Secondary|Number of Referrals Made of Students Attending SBHC|Number of referrals of the 127 students who attended the SBHC from 8 months-1 year of the opening of the clinic|1 year||||participants|||Number
2649542|NCT01676532|Secondary|Number of Students Attending SBHC With New Diagnoses|Number of students attending SBHC with new diagnoses|1 year|120 of the 127 students who attended the SBHC had a new diagnosis. 94 received one new diagnosis and 26 children received more than one new diagnosis|||participants|||Number
2649543|NCT01676532|Secondary|Number of Students Attending SBHC With New Treatment Plans|Proportion of children seen in the clinic with treatment plans|1 year|115 students out of 127 students attending SBHC had a new treatment plan.|||participants|||Number
2649544|NCT01676532|Primary|Number of Enrolled Participants Who Attended SBHC|"The primary objectives are to determine utilization of the SBHC including:~The number of students who are enrolled at the SBHC~The number of enrolled students enrolled who attended the SBHC"|1 year|379 students enrolled in the SBHC and 127 of those students attended SBHC. Existing data is based on 127 students who attended SBHC.|||participants|||Number
2649545|NCT01676415|Secondary|Medication Side-effect and Compliance Inventory|The medication side-effect and compliance inventory is a questionnaire to evaluate the frequency and severity of common side effects associated with the medications used in this study.|4-6 weeks and 3 months after initiation of treatment|Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.|||Participants|||Count of Participants
2649546|NCT01676415|Secondary|Taskforce Symptom Inventory|Change from baseline in individual symptom severity. The taskforce symptom inventory is a visual analog scale of the severity of the 4 major symptoms making up the clinical diagnostic criteria of CRS.|4-6 weeks and 3 months after initiation of treatment|Study had difficult accruing sufficient numbers of patients. Additional Institutional Review Board mandated testing for potential participants made study flow challenging. Study was closed for failure to accrue sufficient patients.|||Participants|||Count of Participants
2649547|NCT01676415|Secondary|Lund-McKay Score From CT Scan|Change from baseline in Lund-McKay scores from sinus CT-scans at 4-6 weeks and 3 months after initiation of treatment will be used to calculate the overall level of inflammation within the paranasal sinuses.|4-6 weeks and 3 months after initiation of treatment|Only a few of the patients were able to return for the follow up CT scan, therefore this measure was not analyzed.||||||
2649548|NCT01676415|Primary|SNOT-22 Questionnaire|"The Sino-nasal Outcome Test-22 is a validated questionnaire that measures 22 nasal and quality of life symptoms (nasal obstruction and loss of smell and taste) ranked from 0 (not a problem) to 5 (problem as bad as it can be).~Min score= 0, Max score= 110 (worst possible problem on all symptoms)~Change from baseline of the SNOT-22 score. The SNOT-22 questionnaire is a 22-item disease-specific health related quality of life instrument validated for use in chronic rhinosinusitis."|4-6 weeks and 3 months after initiation of treatment||||units on a scale||Standard Error|Mean
2649549|NCT01676311|Secondary|Number of Participants With Self-reported Side Effects During 12-week Treatment Window|To evaluate the safety and tolerability of Huperzine A in this patient population as compared to placebo the frequency of self-reported side effects during the 12-week treatment window were grouped categorically by system (behavioral, cardiac-respiratory, dermatological,gastrointestinal, genitourinary/neurological, hematological, musculoskeletal, neurological).|Baseline and weekly for 12 weeks.||||Participants|||Count of Participants
2649550|NCT01676311|Secondary|Number of Participants Who Experienced Post-traumatic Seizure During 12-week Treatment Window|To determine whether Huperzine A changes the prevalence of post-traumatic seizure after moderate and severe TBI as compared to placebo at 12 weeks post-enrollment (immediate seizures prevalence).|Baseline and weekly for 12 weeks.||||Participants|||Count of Participants
2649551|NCT01676311|Secondary|Latency of Event Related Potentials (ERPs) P50 and P300|Event Related Potentials (ERPs): P50 and P300 are neurophysiological measurements that index cortical electrical activity associated with a given stimulus. P50 and P300 were measured using auditory stimuli. P50 represents an index of activity in the cholinergic system and has been used to characterize presynaptic cholinergic deficit and P300 is a measure of general cognitive processing elicited during attention, memory, and executive tasks.|Baseline, 12 weeks|Of the 12 participants who completed the 12-week treatment period, P50 and P500 latency data could be analyzed for 3 participants. Data for the other 9 participants could not be analyzed as the data were compromised by movement artifact during recording.|||ms||Inter-Quartile Range|Median
2649552|NCT01676311|Secondary|Amplitude of Event Related Potentials (ERPs) P50 and P300|Event Related Potentials (ERPs): P50 and P300 are neurophysiological measurements that index cortical electrical activity associated with a given stimulus. P50 and P300 were measured using auditory stimuli. P50 represents an index of activity in the cholinergic system and has been used to characterize presynaptic cholinergic deficit. P300 is a measure of general cognitive processing elicited during attention, memory, and executive tasks.|Baseline, 12 Weeks|Of the 12 participants who completed the 12-week treatment period, P50 and P500 amplitude data could be analyzed for 4 participants. Data for the other 8 participants could not be analyzed as the data were compromised by movement artifact during recording.|||mV||Inter-Quartile Range|Median
2649561|NCT01676220|Secondary|Percentage of Participants With FPG <5.6 mmol/L (100 mg/dL) at Month 6|Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.|Month 6|mITT Population. Participants without any available FPG assessment at Month 6 were considered as failures (non-responders).|||percentage of participants|||Number
2657185|NCT01607853|Secondary|Change From Baseline in Scaling at Day 8|Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 8||||units on a scale||Standard Deviation|Mean
2649553|NCT01676311|Primary|California Verbal Learning Test- 2nd Edition (CVLT-II): Learning and Memory|"Measure of learning and memory function. Three indices of the CVLT-II were calculated. The full name, abbreviated name, and the minimum and maximum possible scores of each index are indicated below:~California Verbal Learning Test- 2nd Edition- Total Learning [CVLT-II-TL] (Minimum score=0; Maximum score= 80)~California Verbal Learning Test- 2nd Edition- Short delay free recall [CVLT-II-SDFR] (Minimum score=0; Maximum score=16)~California Verbal Learning Test- 2nd Edition- Long delay free recall [CVLT-II-LDFR] (Minimum score=0; Maximum score=16)~High scores are indicative of greater memory and learning for each index (i.e. better outcome)."|Baseline, 6 weeks, 12 weeks, 24 weeks and at 52 weeks.||||score on a scale||Standard Deviation|Mean
2649554|NCT01676298|Primary|Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System.|"Reproducibility was calculated as a percentage of the correct calls over the total calls made for each genotype group. All calls were made using the Spartan FRX CYP2C19 genotyping diagnostic system.~All data analyses was qualitative, based on the genotype calls determined by the FRX system (using on-board automated data analysis). A printed result listing the genotype call for each SNP was generated by the FRX system at the end of each run. If the result of a test is Inconclusive for one or more SNPs, the test were immediately repeated for the corresponding SNP(s) only, per the instructions for use. Results are reported based on both first-pass and second-pass (i.e. repeated test). For both the first-pass and second-pass results, 1-sided 95% confidence lower limits were calculated using the score method for the % correct calls (i.e. % agreement)."|After second pass result is complete (~3h)||||Percentage of Correct Calls|Participants|95% Confidence Interval|Number
2649555|NCT01676220|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to 12 months|Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.|||percentage of participants|||Number
2649556|NCT01676220|Secondary|Change in Total Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only DTSQ total score measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with Baseline and at least one post-baseline DTSQ assessment (Week 12 and/or Month 6).|||units on a scale||Standard Error|Least Squares Mean
2649557|NCT01676220|Secondary|Change in Daily Basal Insulin Dose From Baseline to Month 6|Only insulin dose measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with Baseline and Month 6 basal insulin dose assessment.|||U/kg||Standard Deviation|Mean
2649558|NCT01676220|Secondary|Change in Variability of 24 Hour Average 8-point SMPG Profiles From Baseline to Month 6 Endpoint|Variability is assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 5 measurements of the 8-point profiles. Only variability of 24-hour 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline variability of 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).|||percentage of mean||Standard Error|Least Squares Mean
2649559|NCT01676220|Secondary|Change in 24-hour Average 8-point SMPG Profile From Baseline to Month 6 Endpoint|Change in 24-hour average of 8-point SMPG profile. 8-point SMPG was assessed at: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 24-hour average 8-point SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline 24-hour average 8-point SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).|||mmol/L||Standard Error|Least Squares Mean
2649560|NCT01676220|Secondary|Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6|Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only 8-point SMPG profiles measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.|Baseline, Month 6|mITT Population. Only participants from the mITT population with a value at baseline and at specified timepoint were analyzed (represented by n=X, X in the category titles).|||mmol/L||Standard Deviation|Mean
2649724|NCT01675297|Secondary|PTH(Parathyroid Hormone Value)|"range of PTH: 13~54 Higher PTH scores mean a worse outcome.~If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed."|baseline, 6months, 12months||||pg/ml||Standard Deviation|Mean
2649562|NCT01676220|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint|Only FPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants included in the mITT population with baseline and at least one post-baseline FPG assessment (Week 12 and/or Month 6).|||mmol/L||Standard Error|Least Squares Mean
2649563|NCT01676220|Secondary|Percentage of Participants With HbA1c <7% at Month 6|Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 value corresponds to the observed value at Month 6 visit.|Month 6|mITT Population. Participants without any available Month 6 HbA1C assessment were considered as failures (non-responders).|||percentage of participants|||Number
2649564|NCT01676220|Secondary|Variability of Preinjection SMPG at Month 6 Endpoint|Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Month 6|mITT population. Number of participants analyzed = participants included in the mITT Population with at least one pre-injection SMPG variability assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6).|||percentage of mean||Standard Error|Least Squares Mean
2649565|NCT01676220|Secondary|Change in Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint|Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Except for baseline value average of preinjection SMPG was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only preinjection SMPG measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|mITT population. Number of participants analyzed = participants included in the mITT population with baseline and at least one pre-injection SMPG assessment (Week 2, Week 4, Week 8, Week 12, Month 4 and/or Month 6)|||mmol/L||Standard Error|Least Squares Mean
2649566|NCT01676220|Secondary|Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6|Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]). Only nocturnal hypoglycemia occurring before initiation of rescue therapy were considered in the analysis. Week 9 and Month 6 value correspond to the observed value at Week 9 and Month 6 visit respectively.|Week 9 Up to Month 6|Modified intent-to-treat population.|||percentage of participants|||Number
2649567|NCT01676220|Primary|Change in HbA1c From Baseline to Month 6 Endpoint|Only HbA1c measurements performed before initiation of rescue therapy were considered in the analysis. Month 6 Endpoint is either the observed value at Month 6 visit or value retrieved according to time windows.|Baseline, Month 6|Modified Intent-to-Treat (mITT) population:randomized participants who received at least 1 dose, had baseline and at least 1 post-baseline data of any efficacy variable, irrespective of compliance. Number of participants analyzed=participants included in mITT population with baseline and at least 1 post-baseline HbA1c data (Week 12 and/or Month 6).|||percentage of hemoglobin||Standard Error|Least Squares Mean
2649568|NCT01676116|Secondary|Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ).|Mean change in diabetes treatment satisfaction questionnaire (DTSQs) scores from baseline. The scores ranged from 0 to 6. Higher total score on a 0-6 point scale indicates a general higher treatment satisfaction, whereas higher score on perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia indicate that blood glucose levels are out of the target range.|Week 0, week 26|Full analysis set included all randomised subjects. A total of 436 subjects contributed to the analysis. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method.|||Scores on a scale||Standard Deviation|Mean
2649569|NCT01676116|Secondary|Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D)|The patient related outcome is calculated based on TRIM-D questionnaire. The TRIM-D questionnaire consists of 5 sub-domains (treatment burden, daily life, diabetes management, compliance and psychological health), where each question is scored to a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D individual sub-domain scores and total score are later transformed to a 0-100 scale for analysis. The mean change in scores from baseline to 26 weeks for all the individual sub domains and total scores are presented here.|Week 0, week 26|Full analysis set included all randomised subjects. A total of 436 subjects contributed to the analysis. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method.|||Scores on a scale||Standard Deviation|Mean
2649570|NCT01676116|Secondary|Number of Adverse Events (AEs)|Rate (events per 100 exposure years) of treatment-emergent adverse events (an event that had onset date (or an increase in severity) on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment) which occurred during the 26 weeks of treatment.|After 26 weeks of treatment|Full analysis set included all randomised subjects. A total of 436 subjects contributed to the analysis.|||events per 100 exposure years|||Number
2649584|NCT01675635|Secondary|Comparison of the Total Amount of Study Drugs Used During the 24 Hours|"To calculate the total amount of study drugs used during the 24 hours and to conduct inter-group comparison~The study drug administration is average 6 hours,so the maximal is use 4 times in 24 hours. The investigate to evaluate if the subject need to take the 2nd, 3rd and 4th dose after the mandatory the 1st dose."|24 hours after administration of first dose|234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.|||mg||Standard Deviation|Mean
2649571|NCT01676116|Secondary|Number of Severe or Minor Hypoglycaemic Episodes|Rate (events per 100 patient years of exposure) of treatment-emergent confirmed hypoglycaemic episodes. The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes. Severe hypoglycaemia was categorised as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or PG <3.1 mmol/L (56 mg/dL), and which was handled by the subject himself/herself, or any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or PG value <3.1 mmol/L (56 mg/dL).|After 26 weeks of treatment|Full analysis set included all randomised subjects. A total of 436 subjects contributed to the analysis.|||events per 100 patient years of exposure|||Number
2649572|NCT01676116|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Mean change in fasting plasma glucose from baseline, after 26 weeks of treatment.|Week 0, week 26|Full analysis set included all randomised subjects. A total of 430 subjects contributed to the analysis. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method.|||mmol/L||Standard Deviation|Mean
2649573|NCT01676116|Secondary|Change From Baseline in Body Weight|Mean change in body weight after 26 weeks of treatment.|Week 0, week 26|Full analysis set included all randomised subjects. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method.|||kg||Standard Deviation|Mean
2649574|NCT01676116|Secondary|Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)|Percentage of responders achieving pre-defined target for HbA1c - HbA1c ≤ 6.5% (48 mmol/mol).|Week 26|Full analysis set included all randomised subjects. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method.|||Percentage|||Number
2649575|NCT01676116|Secondary|Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)|Percentage of subjects achieving HbA1c below 7.0% after 26 weeks of treatment.|Week 26|Full analysis set included all randomised subjects. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method.|||Percentage|||Number
2649576|NCT01676116|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)||Week 0, week 26|Full analysis set included all the randomised subjects. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
2649577|NCT01676012|Secondary|Sensitivity and Specificity of HD Videobronchoscopy|When the sensitivity and specificity of HD videobronchoscopy in either mode in the abovementioned study is in the vicinity of the reported sensitivity and specificity of SAFE3000 dual mode videobronchoscopy we suggest to use the results of this study perform a power analysis. With this information it may then be possible to design a new future study to compare sensitivity for detecting premalignant lesions in a high risk population in a prospective study.|one year|||||||
2649578|NCT01676012|Primary|Sensitivity|Investigate sensitivity of HD bronchoscopy, with or without surface enhancement or tone enhancement in comparison to AFB (the 'gold standard') and standard WLB for detecting abnormalities of the tracheobronchial tree. So we used 5 types of bronchoscopy; SWL (=standard white light), HD (=high defenition bronchoscopy without surface/tone enhancement), HD-i-Scan1 (=high defention bronchoscopy with surface enhancement), HD-i-scan 2 (=high defenition bronchoscopy with tone enhancement), AFB (=autofluorescence bronchoscopy). Furthermore we aim to investigate determination of resection margins of (suspected) malignancies in the glottic and supraglottic area or centrally located lung cancer in comparison to autofluorescence bronchoscopy (SAFE 3000 dual video mode) in a high risk population with biopsies from all suspect lesions identified by either technique.|one year|Vascular abnormalities were scored most frequently in HD + i-scan2 bronchoscopy. Sites suspicious for preinvasive lesions were most frequently reported using AFB. Tumors were detected equally by all modalities. The preferred modality was HD bronchoscopy with i-scan.|||# vascular sites detected per patient||Standard Error|Mean
2649579|NCT01675960|Secondary|Prevalence of Associated Gastrointestinal and Sleep Problems in Neurologically Impaired Children and Improvement Using Gabapentin.|We will attempt to identify gastrointestinal and sleep problems in neurologically impaired children with questionnaires given throughout the study. We hypothesize that gastrointestinal symptoms (feeding intolerance and symptoms associated with gas and bowel movements) and disrupted sleep are frequently associated with chronic irritability and will improve with gabapentin.|Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).|No one was ever enrolled in the placebo arm. The data was never analyzed for this secondary outcome. PI has left the organization therefore analysis will not occur.||||||
2649580|NCT01675960|Primary|Symptom Relief for Chronic Irritability in Neurologically Impaired Children Using Gabapentin.|We will determine whether gabapentin provides symptom relief for chronic irritability in neurologically impaired children, who continue to have irritability even though potential sources may have been identified and treated, or have sources that have not been identified.|Compiled data reviewed at completion or withdrawal from study (3 months from beginning study).|No one was ever enrolled in the placebo arm. The data was never analyzed for this secondary outcome. PI has left the organization therefore analysis will not occur.||||||
2649581|NCT01675830|Secondary|Redness, Irritation, and/or Hyperthermia Due to Head Wrap Use|To identify and describe adverse events observed with use of the Thermoregulation Head Wrap.|These will be assessed upon admission to the CICU, and in 6 hour follow up increments until the last assessment at 72 hours.|Number of adverse events observed|||adverse events|||Number
2649582|NCT01675830|Primary|Head Wrap Feasibility|To describe the feasibility of placing a Thermoregulation Head Wrap on the infant's head from the time the re-warming process begins to the time baby arrives in the Cardiac Intensive Care Unit (CICU) after transfer from the operating room. Likert scale items assessing feasibility of the head wrap will be completed by clinicians upon patient admission to CICU.|<12 hours|Percentage of respondents that agree device is easy to use|||percentage of respondents|||Number
2649583|NCT01675661|Primary|The Odds of Negative Urine Cannabinoid Tests During Treatment.|The primary outcome is the abstinence rate over the 12 weeks of treatment. Abstinence is based on a weekly urine drug screen confirmed by central laboratory testing and defined as a negative cannabinoid result.|study weeks 2-13|Intent to treat; all participants randomized|||cannabis negative urine tests|||Number
2649585|NCT01675635|Secondary|Satisfaction With Pain Control|"To assess the Satisfaction with pain control during 24 hours after administration of first dose and to conduct inter-group comparison~Very Satisfied~Satisfied~Fair~Not Satisfied~Not Satisfied at all"|24 hours after administration of first dose|234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.|||Participants|||Count of Participants
2649586|NCT01675635|Secondary|Sleeping Quality Assessment|"To assess Sleeping quality assessment during 24 hours after administration of first dose and to conduct inter-group comparison~Sleeping quality scale~Very Good~Good~Fair~Bad~Very Bad"|24 hours after administration of first dose|234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.|||Participants|||Count of Participants
2649587|NCT01675635|Secondary|VAS in Coughing Stage at 6h (6h±20min After Administration of First Dose)|"To measure coughing VAS at 6h (±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison~Visual Analogue Scale~0 10 20 30 40 50 60 70 80 90 100~0 means no pain; 100 means pain as bed as you can image applicable for both resting and coughing stage"|Baseline and 6h (±20min)|234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.|||units on a scale||Standard Deviation|Mean
2649588|NCT01675635|Secondary|The Use of Rescue Analgesics During the 24-hour Observation Period|To calculate the subject who used rescue analgesics during the 4 dose interval within the 24-hour observation period and to conduct inter-group comparison|24 hours after the first dose.|in FAS population|||Participants|||Count of Participants
2649589|NCT01675635|Secondary|VAS in Both Resting and Coughing Stage at 0.5h, 2h and 24h After Administration of First Dose|To measure the resting and coughing VAS as 0.5h (±5min), 2h (±10min) and 24h (±20min) after administration of first dose, assessing the intensity of pain and to conduct inter-group comparison|Baseline,0.5h (±5min), 2h (±10min) and 24h (±20min)||||units on a scale||Standard Deviation|Mean
2649590|NCT01675635|Primary|Visual Analogue Scale (VAS) in Resting Stage at 6hour (6hour±20 Minutes After Administration of First Dose)|"To measure resting VAS at 6h(±20min) after administration of first dose, assessing the intensity of pain, and to conduct inter-group comparison~Visual Analogue Scale~0 10 20 30 40 50 60 70 80 90 100~0 means no pain; 100 means pain as bad as you can image at resting stage"|Baseline and 6h (±20min)|234 subjects in Full Analysis Set (FAS) in which 4 subjects from each group was excluded for Per Protocol(PP) population, so 113 subjects in PP population in each group for the primary endpoint analysis.|||units on a scale||Standard Deviation|Mean
2649591|NCT01675622|Secondary|Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment|For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%).|baseline up to 19-22 days (open label treatment)||||percentage of pain relief||Standard Deviation|Mean
2649592|NCT01675622|Secondary|Degree of Pain Relief Within 24hrs After Treatment|Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period. The BPI is the average number of above 4 BPI Pain Items. For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%).|baseline up to 5-8 days (double blind period)||||percentage of pain relief||Standard Deviation|Mean
2649593|NCT01675622|Secondary|the Total Dose of Rescue Medicine for Breakthrough Pain.|the total dose of rescue medicine for breakthrough pain during double blind phase between the two treatment groups|baseline up to 22 days (double blind period)|The double-blind titration period was the dose adjusting phase, so breakthrough pain occurrences in this period were not included in statistical analysis. After titration was completed, subjects entered into maintenance treatment with the titrated dose.|||mg||Standard Deviation|Mean
2649594|NCT01675622|Secondary|Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment|The secondary outcome measurement is the change of BPI score from baseline to the end of open label treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items.|baseline up to 19-22 days (open label treatment)||||scores on a scale||Standard Deviation|Mean
2649595|NCT01675622|Secondary|Average Number of Titrations|the average times to change the dose in order to find the proper dose between two treatment groups|baseline up to 1-3 days(double blind period)|Dosing change frequency for complete titration|||dose changes||Standard Deviation|Mean
2649596|NCT01675622|Secondary|Patient Assessments of Satisfaction for Pain Management|the number of patients of satisfaction for pain management between the two treatment groups at the end of double blind treatment and the open label treatment period.|baseline up to 19-22 days (open label treatment)||||Participants|||Count of Participants
2649597|NCT01675622|Secondary|Times of Breakthrough Pain Occurrence|the times of breakthrough pain occurrence during double blind treatment phase between the two treatment groups|Within 8 days after baseline||||breakthrough pain events|||Number
2649598|NCT01675622|Secondary|Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period|The secondary outcome measurement is the change between BPI score at baseline and after completion of double blind treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in the passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items.|baseline up to 5-8 days (double blind period)||||scores on a scale||Standard Deviation|Mean
2649599|NCT01675622|Secondary|The Average Dose of Study Medicine Used During Double Blind Treatment Period|the average dose of study medicine used during double blind treatment period between the two treatment groups.|baseline up to 5-8 days (double blind period)|The average total dosage during double-blind treatment was defined as a primary efficacy endpoint in the protocol, but this study was a non-inferiority study, and non-inferiority analysis could not be performed in average total dosage in data processing and statistics.|||mg||Standard Deviation|Mean
2649600|NCT01675622|Primary|Numerical Rating Scale (NRS)|The numerical rating scale is the tool to assess pain level using a numerical rating scale. The primary outcome measurement is the average change of NRS score after double blind treatment between the two treatment groups. The NRS evaluates the pain level using number scale from 0 to 10. 0 means not painful and 10 means extremely painful. 1 to 3 is lightly pain, 4-6 is moderate pain and 7 to 10 is severe pain. There is no subscales used for NRS reporting.|baseline up to 5-8 days (double blind period)||||scores on a scale||Standard Deviation|Mean
2649601|NCT01675596|Secondary|All Cause Mortality||12 months||||percentage of participants|||Number
2649602|NCT01675596|Secondary|All Cause Mortality||30 days||||percentage of patients|||Number
2649603|NCT01675596|Primary|VARC-2 Composite Safety Endpoint|"The primary endpoint is a VARC-2 Composite. It comprises of~All cause mortality~All stroke~Life-threatening bleeding~Acute kidney injury - Stage 3 (including renal replacement therapy)~Coronary artery obstruction requiring intervention~Major vascular complications~Valve related dysfunction (requiring repeat procedure)~A composite endpoint is an endpoint that is a combination of multiple components."|30 days||||percentage of patients|||Number
2649604|NCT01675544|Primary|Mortality|All cause mortality at 1 year|1 year||||participants|||Number
2649605|NCT01675544|Primary|Emergency Room Visit or Hospitalization for Acute Decompensated Heart Failure (ADHF)||1 year||||participants|||Number
2649606|NCT01675531|Secondary|Patient's Overall Satisfaction|Patient's overall satisfaction was assessed 7 scales from very much worse to very much improved. (Very much worse, much worse, minimally worse, no change, minimally improved, much improved, very much improved)|4weeks|Analysis of ITT population set.|||participants|||Number
2649607|NCT01675531|Secondary|Physician's Overall Satisfaction|Physician's overall satisfaction was scored 7 scales from Very much worse to Very much improved. (Very much worse, much worse, minimally worse, No change, Minimally improved, much improved, very much improved).|4 weeks|Analysis of ITT population set.|||participants|||Number
2649608|NCT01675531|Secondary|Mean Change in FACT-GOG/NTX From Visit1(Week 0) to Visit 4(Week 4 Post-treatment).|"Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FAICT-GOG/NTX).~The mean changes in FACT/GOG-NTX total score and each FACT/GOG-NTX subscale score from Visit 1 (Week 0) to Visit 4 (Week 4 post-treatment) were analyzed. Missing data was handled as LOCF(Last Observation Carried Forward Method).~FACT/GOG-NTX total score range was from 0 to 152. The average change score from baseline to visit 4 indicates thay a lower score on the FACT/GOG-NTX means lower quality of life and a greater impact of neurotoxic symptom on the patient's life."|4 weeks|Analysis of ITT population set.|||units on a scale||Standard Deviation|Mean
2649609|NCT01675531|Primary|NRS (Numeric Rating Scale)|"Change of pain intensity score via NRS after vist 4 weeks treatment from baseline (week 0).~NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week4/ET minus mean score at Baseline."|4 weeks|Analysis of ITT population set. Missing data was handled as LOCF(Last Observation Carried Forward Method).|||units on a scale||Standard Deviation|Mean
2649610|NCT01675492|Secondary|Uncorrected Visual Acuity (UCVA) of 20/40 or Better|85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters|3 Months||||eyes|eyes||Count of Units
2649611|NCT01675492|Primary|Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA)|< 5% of eyes will have a loss of > 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters|3 Months||||eyes|eyes||Count of Units
2649612|NCT01675479|Secondary|Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better|Hypothesis: 85% of eyes will have uncorrected visual acuity of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters|12 Months||||eyes|eyes||Count of Units
2649613|NCT01675479|Primary|Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA)|Hypothesis: <5% of eyes will have a loss of > 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters|12 Months||||eyes|eyes||Count of Units
2649614|NCT01675453|Secondary|Chloride Loading|The amount of chloride ions (mmol per patient) which will be infused during the surgery and ICU stay|24 h|||||||
2649615|NCT01675453|Secondary|Duration of Mechanical Ventilation||24 hours|||||||
2649616|NCT01675453|Secondary|Blood Loss|Bleeding from chest tubes|24 hours|||||||
2649617|NCT01675453|Secondary|Rate of Neurological Complications|Delirium, clinically diagnosed stroke, and encephalopathy.|24 hours|||||||
2649618|NCT01675453|Secondary|Stroke Volume Index||24 hours|||||||
2649619|NCT01675453|Secondary|Rate of Hyperchloremic Metabolic Acidosis|blood pH, base excess (BE), plasma level of Cl will be used to assess this outcome measure.|24 hours|||||||
2649620|NCT01675453|Secondary|Rate of Acute Kidney Injury|serum creatinine, serum cystatin C, urine neutrophil gelatinase-associated lipocalin (uNGAL) will be used to asses this outcome measure.|48 hours|||||||
2649621|NCT01675453|Secondary|Plasma Osmolarity||24 hours|||||||
2649622|NCT01675453|Secondary|Plasma Na||24 hours|||||||
2649623|NCT01675453|Secondary|Endothelial Integrity|Serum levels of intercellular adhesion molecule-1 (ICAM-1), E-selectin will be used to assess this outcome measure.|24 hours|||||||
2649624|NCT01675453|Secondary|Inflammation Response|Serum levels of Interleukin 6 (IL-6) and Interleukin 10 (IL-10) will be used to assess this outcome measure.|24 hours|||||||
2649625|NCT01675453|Secondary|Fluid Balance|Net fluid balance at the end of surgery equals the sum of all infusions minus the urine output. Net fluid balance at postoperative day 1 equals the sum of all infusions minus the urine output and blood loss.|24 hours|||||||
2649626|NCT01675453|Secondary|Cardiac Index||24 hours|||||||
2649627|NCT01675453|Secondary|Oxygen Delivery|Oxygen delivery index (DO2I) will be used to assess this outcome measure.|24 hours|||||||
2649628|NCT01675453|Secondary|Pulmonary Oxygenation|Index of arterial oxygenation efficiency (PaO2/FiO2), alveolar-arterial oxygen tension difference (AaDO2) will be used to assess this outcome measure.|24 hours|||||||
2649725|NCT01675297|Secondary|The Change of 25OHD(25-hydroxyvitamin D)|"range of 25OHD: 4.80~52.80 Higher 25OHD scores mean a better outcome.~If there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed."|baseline, 6months, 12months||||ng/ml||Standard Deviation|Mean
2649629|NCT01675453|Primary|Extravascular Lung Water Index|"Extravascular lung water index (ELWI; mL/kg) will be used to assess this outcome measure. ELWI was monitored by transcardiopulmonary thermodilution technique with the PiCCO plus system. Extravascular lung water represents the extravascular fluid of the lung tissue. It includes intra-cellular, interstitial and intra-alveolar water (not pleural effusion). It is indexed to Predicted Body Weight."|baseline; 5 min after infusion; 5 min after CPB; 30 min after CPB; end of surgery; 2 h, 4 h, 6 h, 12 h after CPB; Postoperative day 1||||mL/kg||Inter-Quartile Range|Median
2649630|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records. Past medication use was obtained from medical records and/or participant interview at the Study Visit. Participants with a history of erythropoietin use during prior treatment for CHC were recorded as 'yes' for this finding.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649631|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records. Past medication use was obtained from medical records and/or participant interview at the Study Visit. Participants with a history of erythropoietin use during prior treatment for CHC were recorded as 'yes' for this finding.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649632|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype and hematology data were obtained from medical records. Participants with a history of a hemoglobin level less than 10 g/dL or a drop of more than 3 g/dL at any time during prior treatment for CHC were recorded as 'yes' for this finding.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649633|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype and hematology data were obtained from medical records. Participants with a history of a hemoglobin level less than 10 grams per deciliter (g/dL) or a drop of more than 3 g/dL at any time during prior treatment for CHC were recorded as 'yes' for this finding.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649634|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Overall Virological Response Type and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Overall virological response types included SVR, relapse, and breakthrough. SVR was defined as undetectable HCV RNA level at 24 weeks post-treatment, relapse as an undetectable level at end of treatment with a detectable level at the last post-treatment measurement, and breakthrough as an undetectable level at 1 or more treatment measurements with a detectable level at end of treatment. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site. Response categories were mutually exclusive. Participants with detectable HCV RNA level at 12 or more treatment measurements and who did not meet SVR criteria were considered nonresponders, and those with insufficient treatment response data were recorded as 'none of the above.'|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649635|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Overall Virological Response Type and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Overall virological response types included sustained virological response (SVR), relapse, and breakthrough. SVR was defined as undetectable HCV RNA level at 24 weeks post-treatment, relapse as an undetectable level at end of treatment with a detectable level at the last post-treatment measurement, and breakthrough as an undetectable level at 1 or more treatment measurements with a detectable level at end of treatment. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site. Response categories were mutually exclusive. Participants with detectable HCV RNA level at 12 or more treatment measurements and who did not meet SVR criteria were considered nonresponders, and those with insufficient treatment response data were recorded as 'none of the above.'|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649636|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response at End of Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types at the end of treatment included undetectable and detectable HCV RNA level. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649637|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response at End of Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types at the end of treatment included undetectable and detectable HCV RNA level. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649710|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||participants|||Number
2649638|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types within the first 12 weeks of treatment included RVR, cEVR, and pEVR. RVR was defined as an undetectable HCV RNA level within the first 4 weeks, cEVR as an undetectable level within the first 12 weeks, and pEVR as a 2-log drop from Baseline to 12 weeks. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site. Response categories were mutually exclusive, meaning participants could only achieve cEVR/pEVR in the absence of RVR. Participants achieving neither RVR nor cEVR/pEVR were recorded as 'none of the above.'|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649639|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types within the first 12 weeks of treatment included rapid virological response (RVR), complete early virological response (cEVR), and partial early virological response (pEVR). RVR was defined as an undetectable HCV RNA level within the first 4 weeks, cEVR as an undetectable level within the first 12 weeks, and pEVR as a 2-log drop from Baseline to 12 weeks. Undetectable viral loads include those below the lower limit of detection (LLOD) for the assay performed, which may vary from site to site. Response categories were mutually exclusive, meaning participants could only achieve cEVR/pEVR in the absence of RVR. Participants achieving neither RVR nor cEVR/pEVR were recorded as 'none of the above.'|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649640|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
2649641|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
2649642|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
2649643|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
2649644|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
2649645|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
2649646|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
2649647|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
2649648|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649649|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649650|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649651|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649652|NCT01675427|Secondary|Number of Participants With ITPA Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine ITPA genotype.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||participants|||Number
2649653|NCT01675427|Secondary|Number of Participants With Inosine Triphosphatase (ITPA) Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine ITPA genotype.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||participants|||Number
2649654|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||participants|||Number
2649655|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||participants|||Number
2649656|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
2649657|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
2649658|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
2649659|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
2649694|NCT01675427|Secondary|Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||log10 IU/mL||95% Confidence Interval|Mean
2649660|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
2649661|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
2649662|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G4, Other, Total) is a continuation of the preceding table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
2649663|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category. The table below (G1, G2, G3) is continued onto the subsequent table; thus, the overall number of participants analyzed reflects the total number analyzed among all genotypes (G1, G2, G3, G4, and Other).|||participants|||Number
2649664|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649665|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649666|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649667|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649668|NCT01675427|Secondary|Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||10^9 cells/L||95% Confidence Interval|Mean
2649669|NCT01675427|Secondary|Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||10^9 cells/L||95% Confidence Interval|Mean
2649670|NCT01675427|Secondary|Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||10^9 cells/L||95% Confidence Interval|Mean
2649671|NCT01675427|Secondary|Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells per liter (10^9 cells/L).|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||10^9 cells/L||95% Confidence Interval|Mean
2649672|NCT01675427|Secondary|Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||ratio||95% Confidence Interval|Mean
2649673|NCT01675427|Secondary|Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||ratio||95% Confidence Interval|Mean
2649674|NCT01675427|Secondary|Mean AST Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||ratio||95% Confidence Interval|Mean
2649675|NCT01675427|Secondary|Mean Aspartate Aminotransferase (AST) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||ratio||95% Confidence Interval|Mean
2649676|NCT01675427|Secondary|Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 IU/L for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||ratio||95% Confidence Interval|Mean
2649677|NCT01675427|Secondary|Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 IU/L for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||ratio||95% Confidence Interval|Mean
2649678|NCT01675427|Secondary|Mean ALT Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 IU/L for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||ratio||95% Confidence Interval|Mean
2649679|NCT01675427|Secondary|Mean Alanine Aminotransferase (ALT) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 international units per liter [IU/L] for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||ratio||95% Confidence Interval|Mean
2649680|NCT01675427|Secondary|Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||log10 IU/mL||95% Confidence Interval|Mean
2649681|NCT01675427|Secondary|Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||log10 IU/mL||95% Confidence Interval|Mean
2649682|NCT01675427|Primary|Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||kPa||95% Confidence Interval|Mean
2649726|NCT01675297|Primary|The Change of Bone Mineral Density (BMD) Value|Higher Bone Mineral Density(BMD) value mean a better outcome.|baseline and 12 months||||g/cm^2||Standard Deviation|Mean
2649683|NCT01675427|Primary|Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||kPa||95% Confidence Interval|Mean
2649684|NCT01675427|Primary|Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||kPa||95% Confidence Interval|Mean
2649685|NCT01675427|Primary|Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kilopascals (kPa).|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||kPa||95% Confidence Interval|Mean
2649686|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649687|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649688|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649689|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649690|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649691|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649692|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649693|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649695|NCT01675427|Secondary|Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 international units per milliliter (log10 IU/mL).|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||log10 IU/mL||95% Confidence Interval|Mean
2649696|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||participants|||Number
2649697|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||participants|||Number
2649698|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||participants|||Number
2649699|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||participants|||Number
2649700|NCT01675427|Secondary|BMI by IL28B Genotype rs8099917: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||kg/m^2||95% Confidence Interval|Mean
2649701|NCT01675427|Secondary|BMI by IL28B Genotype rs8099917: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||kg/m^2||95% Confidence Interval|Mean
2649702|NCT01675427|Secondary|BMI by IL28B Genotype rs12979860: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||kg/m^2||95% Confidence Interval|Mean
2649703|NCT01675427|Secondary|Mean Body Mass Index (BMI) by IL28B Genotype rs12979860: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kilograms per meter-squared (kg/m^2), and mean BMI was calculated by averaging the values of all participants within each arm.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||kg/m^2||95% Confidence Interval|Mean
2649704|NCT01675427|Secondary|Mean Body Weight by IL28B Genotype rs8099917: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||kg||95% Confidence Interval|Mean
2649705|NCT01675427|Secondary|Mean Body Weight by IL28B Genotype rs8099917: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||kg||95% Confidence Interval|Mean
2649706|NCT01675427|Secondary|Mean Body Weight by IL28B Genotype rs12979860: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||kg||95% Confidence Interval|Mean
2649707|NCT01675427|Secondary|Mean Body Weight by IL28B Genotype rs12979860: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kilograms (kg).|Study Visit 1|Core Analysis Population (Treatment-Naive).|||kg||95% Confidence Interval|Mean
2649708|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||participants|||Number
2649709|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||participants|||Number
2649711|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||participants|||Number
2649712|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||participants|||Number
2649713|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||participants|||Number
2649714|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Experienced).|||participants|||Number
2649715|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.|Study Visit 1|Core Analysis Population (Treatment-Naive).|||participants|||Number
2649716|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649717|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649718|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649719|NCT01675427|Secondary|Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649720|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649721|NCT01675427|Primary|Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Naive); n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649722|NCT01675427|Primary|Number of Participants With IL28B Genotype rs12979860 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.|Study Visit 1|Core Analysis Population (Treatment-Experienced): Only participants who had received prior treatment for CHC were included in the analysis; n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649723|NCT01675427|Primary|Number of Participants With Interleukin 28B (IL28B) Genotype rs12979860 by Cirrhosis Status and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Genotype: Treatment-Naive|Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype (Genotype 1 [G1], Genotype 2 [G2], Genotype 3 [G3], Genotype 4 [G4], and all other genotypes [Other]) and cirrhosis status ('Cirrhosis/transition to cirrhosis' or 'No cirrhosis') were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.|Study Visit 1 (single study visit)|Core Analysis Population (Treatment-Naive): Only participants who had not received prior treatment for CHC were included in the analysis; n = number of participants analyzed within each HCV RNA genotype category.|||participants|||Number
2649727|NCT01675167|Secondary|Medical Outcomes Score Sleep Subscale - Quantity of Sleep/Optimal Sleep|Medical Outcomes Score (MOS) Sleep scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The quantity of sleep dimension is the average number of hours of sleep per night reported and optimal sleep is when the number of hours of sleep is ≥7.|Week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (19). Includes only participants with MOS assessment at week 12 (n=231 buprenorphine and n=230 placebo).|||participants|||Number
2649728|NCT01675167|Secondary|Change From Baseline to Week 12 in Medical Outcome Score Sleep Subscale|Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep).|Baseline, Week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (19). Includes only participants with MOS assessment at week 12 (n=231 buprenorphine and n=230 placebo).|||units on a scale||Standard Deviation|Mean
2649729|NCT01675167|Secondary|Change From Baseline to Week 12 in Roland Morris Disability Questionnaire|Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.|Baseline, week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (19). Includes only participants with RMDQ assessment at week 12 (n=225 buprenorphine and n=231 placebo).|||units on a scale||Standard Deviation|Mean
2649730|NCT01675167|Secondary|Patient Global Impression of Change|Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change [or condition has got worse]) to 7 (a great deal better, and a considerable improvement that made all the difference)|Week 12|Analysis based on Patient-Reported Outcomes (PRO) population; randomized subjects who received at least 1 dose of double-blind medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site excluded from population (19). Includes only participants with PGIC assessment at week 12 (n=231 buprenorphine and n=230 placebo).|||units on a scale||Standard Deviation|Mean
2649731|NCT01675167|Secondary|Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)|Treatment failure is defined as study discontinuation due to lack of efficacy or discontinuation due to adverse events in the double-blind treatment phase.|Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.|||percentage of participants|||Number
2649732|NCT01675167|Secondary|Time to Optimal Dose of Open-label Study Medication|"Overall time to reach the optimum dose of study medication required to progress to double-blind treatment"|Up to 8 weeks in open-label titration|Analysis based on randomized subjects in the Safety population; all subjects who received at least 1 dose of study medication and were randomized into double-blind treatment|||days||Standard Deviation|Mean
2649733|NCT01675167|Secondary|Number of Subjects With Opioid Rescue Medication Use|Use of analgesic rescue medication recorded in subject diary|Week 1 to Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.|||participants|||Number
2649734|NCT01675167|Secondary|Number of Participants With Response to Treatment (Responder) Using NRS Scale|Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to week 12 in double-blind treatment. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Prior to open-label titration to week 12 in double-blind treatment|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.|||participants|||Number
2649735|NCT01675167|Primary|Change From Baseline to Week 12 in Average Daily Pain Intensity Scores|Change in pain intensity = average of daily pain scores from the last 7 days prior to week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Baseline, week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 19 subjects from 1 site were excluded from the population.|||units on a scale||Standard Deviation|Mean
2649736|NCT01675141|Secondary|Expression of Cereblon (CRBN) and How it Relates to Natural Killer (NK) Cell Number and Activity|Relative fold change in CRBN and correlation (R2) to NK cell number and activity.|participants were followed for the duration of their treatment, an average of 2 years|This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.||||||
2649747|NCT01675128|Secondary|Overall Survival|Overall survival is defined as the time from the on study date until the date of death or date last known alive.|≥ 12 months|Only 6/10 participants in Phase I, Dose Level II and 9/10 participants in Phase II were evaluable. Per protocol, overall survival was not to be reported for the Phase I Dose Level I Arm because the participants have different histologies, thus overall survival data for Phase I Dose Level I.|||participants|||Number
2649737|NCT01675141|Secondary|Changes in B Cell Subsets, Myeloid Derived Suppressor Cells and T Regulatory Cells by Phenotypic Analysis During the Course of Therapy|Percent change in total number of B Cell Subsets, Myeloid Derived Suppressor Cells and T Regulatory Cells by Phenotypic Analysis During the Course of Therapy|participants were followed for the duration of their treatment, an average of 2 years|This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.||||||
2649738|NCT01675141|Secondary|Natural Killer (NK) Cell Function and Activity|Percent of target cell lysis by NK cells|participants were followed for the duration of their treatment, an average of 2 years|This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.||||||
2649739|NCT01675141|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from study entry until progression or death. Progression is assessed by the International Myeloma Workshop Consensus Panel Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from baseline or lowest response value in Serum M component, Urine M component, free light chain or bone marrow plasma cell percentage. Lowest response value does not need to be a confirmed value. Serum M-component absolute increase must be ≥0.5 g/dl. The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥5 g/dl. Urine M-component absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the absolute increase in difference between involved and uninvolved free light chain levels must be >10mg/dl.|participants were followed for the duration of their treatment, an average of 2 years||||months||95% Confidence Interval|Median
2649740|NCT01675141|Secondary|Duration of Response|Duration of response is defined as time from response to disease progression or death. Progression is assessed by the International Myeloma Workshop Consensus Panel Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from baseline or lowest response value in Serum M component, Urine M component, free light chain or bone marrow plasma cell percentage. Lowest response value does not need to be a confirmed value. Serum M-component absolute increase must be ≥0.5 g/dl. The serum M-component increases of ≥1 gm/dl are sufficient to define relapse if starting M-component is ≥5 g/dl. Urine M-component absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the absolute increase in difference between involved and uninvolved free light chain levels must be >10mg/dl.|participants were followed for the duration of their treatment, an average of 2 years||||Months||95% Confidence Interval|Median
2649741|NCT01675141|Secondary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|37 months and 12 days||||Participants|||Count of Participants
2649742|NCT01675141|Primary|Longitudinal Assessment of T Cell (Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8), Natural Killer T-cell (NKT) and Natural Killer (NK) Cell Counts|Peripheral blood samples will be collected to assess T cell (CD4, CD8), NKT and NK cell counts using flow cytometry.|participants were followed for the duration of their treatment, an average of 2 years|This outcome was not done because this study was closed prior to full enrollment. Given study closure, the primary endpoint could not be and was not evaluated. There was not an adequate amount of specimens collected to arrive to any analyses conclusions.||||||
2649743|NCT01675128|Secondary|Number of Participants With a Decrease in elF4E mRNA Expression in Peripheral Blood|Peripheral blood analysis of elF4E mRNA expression was performed using real time quantitative polymerase chain reaction (q-PCR) to assess the downstream effect and determine if proteins are being manufactured. The number of participants with a decrease (criteria unavailable) in elF4E determines if the drug is working. Cell proliferation or reduction was evaluated by a pathologist.|2 weeks|Per protocol, this outcome measure was assessed in the phase II portion only because all participants were getting the same dose.|||participants|||Number
2649744|NCT01675128|Secondary|Number of Participants With a Reduced Effect of elF4E Inhibition on Relevant Regulated Proteins|Protein levels in the biopsy sample was assessed by immunohistochemistry using anti-oligonucleotide antibody to assess the downstream effect and determine if proteins are being manufactured. The number of participants with a reduced effect (criteria unavailable) of elF4E inhibition on relevant regulated proteins determines if the drug is working.|2 weeks|Per protocol, this outcome measure was assessed in the phase II portion only because all participants were getting the same dose.|||participants|||Number
2649745|NCT01675128|Secondary|Number of Participants With Intracellular and Stromal Presence of ISIS in Tumor Tissue|Intracellular and stromal presence of ISIS in tumor tissue was assessed by immunohistochemistry (IHC) and Crystal Violet staining to determine effectiveness of drug. Tissue that retains stain indicates intracellular and stromal presence of ISIS and determines if the drug is working. Relative staining intensity (intensity criteria unavailable) was evaluated by a pathologist.|2 weeks|Per protocol, this outcome measure was assessed in the phase II portion only because all participants were getting the same dose.|||participants|||Number
2649746|NCT01675128|Secondary|AUC(ALL) (Area Under the Plasma Concentration vs. Time Curve for All Time Points)|AUC(ALL) (Area under the plasma concentration vs. time curve for all time points) was assessed for CPT-11 (irinotecan), its active metabolite SN38, and the glucuronic acid metabolite of SN38, SN38-G to derive the total AUC(ALL).|up to 24 hours post end of infusion|Phase I Dose Level I and Phase I Dose Level II were grouped together for this outcome measure. Complete pharmacokinetic data for only ten of the fourteen participants enrolled on the phase I portion of the study were available for analysis. Data is unavailable to report each individual time point.|||hr*ng/mL||Standard Deviation|Mean
2649810|NCT01674621|Secondary|Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BALP) at 6 Months||Baseline and 6 months|Modified intent-to-treat population included all patients with pre-treatment and end-of-treatment evaluable DXA assessments. The patients are analyzed as randomized.|||Percent change||Standard Deviation|Mean
2649748|NCT01675128|Secondary|Number of Participants With Progression Free Survival|Progression free survival is defined as the time beginning on the on study date and continuing until date of progression or date removed from study for an adverse event.|≤ 6 months|Only 6/10 participants in Phase I, Dose Level II and 9/10 participants in Phase II were evaluable. Per protocol, progression free survival was not to be reported for the Phase I Dose Level I Arm because the participants have different histologies, thus there is no progression free survival data for Phase I Dose Level I.|||participants|||Number
2649749|NCT01675128|Secondary|Objective Response|Objective response was evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in short axis to <10mm. Partial response (PR) is at least a 30% reduction in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of athe diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more lesions is also considered progression).|up to 2 cycles|Only 6/10 participants in Phase I, Dose Level II and 9/10 participants in Phase II were evaluable for response. Per protocol, no responses were to be reported for the Phase I Dose Level I Arm because the participants have different histologies, thus there are no objective responses for Phase I Dose Level I.|||participants|||Number
2649750|NCT01675128|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|21 months||||participants|||Number
2649751|NCT01675128|Primary|Number of Participants With a Change in elF4e Protein Levels in Matched Pre and Post Tumor Biopsies|A change in protein is defined as an increase or decrease compared to baseline and is measured between two time points by immunohistochemistry (IHC) analysis.|2 weeks|Mandatory pre- and post-dose biopsies for elF4e messenger ribonucleic acid (mRNA) analysis was performed in the phase II portion of the study.|||participants|||Number
2649752|NCT01675128|Primary|Number of Participants With a Change in the Level of a Particular Gene Called elF4E [Eukaryotic Initiation Factors (elF)4e Messenger Ribonucleic Acid (mRNA) Levels] in Matched Pre and Post Tumor Biopsies|A change in elF4e levels is defined as an increase or decrease compared to baseline and is measured between two time points before rand after 2 weeks of treatment by quantitative real-time reverse transcription polymerase chain reaction (qRT-PCR).|2 weeks|Mandatory pre- and post-dose biopsies for elF4e messenger ribonucleic acid (mRNA) analysis was performed in the phase II portion of the study.|||participants|||Number
2649753|NCT01675128|Primary|Maximum Tolerated Dose of Irinotecan in Advanced Solid Tumors|MTD is the dose level at which no more than 1 of up to 6 patients experience dose-limiting toxicity (DLT) during the first 6 weeks of treatment, and no dose below that which at least 2 (of </=6) patients have DLT as a result of the drug.|2 years||||mg/m^2|||Number
2649754|NCT01675128|Primary|Maximum Tolerated Dose (MTD) of ISIS 183750 in Advanced Solid Tumors|MTD is the dose level at which no more than 1 of up to 6 patients experience dose-limiting toxicity (DLT) during the first 6 weeks of treatment, and no dose below that which at least 2 (of </=6) patients have DLT as a result of the drug.|2 years||||mg|||Number
2649755|NCT01675063|Primary|Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output|The primary outcome of this work is to establish a dataset that would enable the calculation of a predicted cardiac output using waveform analysis from multiple sensors. The primary outcome of this work is the number of subjects that successfully contributed data.|8 hours post cardiac surgery|patients had undergone routine cardiac surgery. some patients did not have PA catheters placed and subsequently data was not obtained on cardiac output.|||Participants|||Count of Participants
2649756|NCT01675050|Secondary|Abdominal Pain|"Participants rated the highest intensity of abdominal pain they experienced during the past two weeks on a scale of 0 (No Pain) to 10 (The Most Pain Possible), as derived from the Abdominal Pain Index - Child Version (Laird et al. 2015. Journal of Pediatric Psychology, 40(5), 517-525)."|10 weeks||||units on a scale||Standard Deviation|Mean
2649757|NCT01675050|Primary|Pressure Pain Threshold|Increasing pressures were applied with a pressure plunger to the participants' thumbnail. The pressure at which the participant said that s/he felt pain is noted. The pressure is measured in kilograms by centimeters squared.|at 4 weeks of cyproheptadine or placebo treatment||||kg/cm^2||Standard Deviation|Mean
2649758|NCT01675011|Primary|Primary Endpoint|The primary effectiveness endpoint for this clinical trial is the proportion of subjects who have success, defined as 50% menstrual blood loss (MBL) reduction or less than 80 ml of MBL per cycle, evaluated by the Alkaline Hematin (AH) method, at 12 months.|12 Months post study procedure|The study was terminated due to inadequate enrollment; no patients completed the 12 month visit.||||||
2649759|NCT01674725|Secondary|Percentage of Participants With Virologic Relapse After Treatment|Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 0%.|Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (ITT GT1b population) with HCV RNA < LLOQ at the final treatment visit and completed treatment.|||percentage of participants||95% Confidence Interval|Number
2649760|NCT01674725|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).|Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] population).|||percentage of participants|||Number
2649761|NCT01674725|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.~The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333 compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV."|12 weeks after last dose of study drug|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
2649762|NCT01674725|Secondary|Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment|The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.|Baseline (Day 1) and Week 12 (End of Treatment)|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b]) and had hemoglobin ≥ LLN reference range at baseline.|||percentage of participants|||Number
2649763|NCT01674725|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses|"The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.~The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b infection treated with telaprevir and peginterferon (pegIFN)/RBV."|12 weeks after last dose of study drug|All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
2649764|NCT01674712|Secondary|Cystatin C|Collection and measurement of blood samples|12 weeks|||||||
2649765|NCT01674712|Secondary|Total Bilirubin|Collection and measurement of blood samples|12 weeks|||||||
2649766|NCT01674712|Secondary|Plasma Creatinine|Collection and measurement of blood samples|12 weeks|||||||
2649767|NCT01674712|Secondary|Alanine Aminotransferase (ALT)|Collection and measurement of blood samples|12 weeks|||||||
2649768|NCT01674712|Secondary|Creatine Kinase (CK)|Collection and measurement of blood samples|12 weeks|||||||
2649769|NCT01674712|Secondary|Adverse Events|Collection and measurement of blood samples|12 weeks|||||||
2649770|NCT01674712|Secondary|Percentage of Subjects Meeting Target Levels of Lipids (According to Very High or High Risk)|Collection and measurement of blood samples|12 weeks|||||||
2649771|NCT01674712|Secondary|Percentage of High-sensitivity C-reactive Protein (hsCRP) From Baseline|Collection and measurement of blood samples|12 weeks|||||||
2649772|NCT01674712|Secondary|Percentage of Apolipoprotein B From Baseline|Collection and measurement of blood samples|12 weeks|||||||
2649773|NCT01674712|Secondary|Percentage of Apolipoprotein AI From Baseline|Collection and measurement of blood samples|12 weeks|||||||
2649774|NCT01674712|Secondary|Percentage of TC (Triglyceride) From Baseline|Collection and measurement of blood samples|12 weeks|||||||
2649775|NCT01674712|Secondary|Percentage of Non-HDL (High Density Lipoprotein)-C From Baseline|Collection and measurement of blood samples|12 weeks|||||||
2649776|NCT01674712|Primary|Percentage of Change of LDL-C (Low Density Lipoprotein Cholesterol)|Collection and measurement of blood samples.|from baseline to 12 weeks of treatment|The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.|||percentage of change||Standard Deviation|Mean
2649777|NCT01674712|Primary|Percentage of Change of HDL-C (High Density Lipoprotein Cholesterol)|Collection and measurement of blood samples.|from baseline to 12 weeks of treatment|The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.|||percentage of change||Standard Deviation|Mean
2649778|NCT01674712|Primary|Percentage of Change of TG (Triglyceride)|Collection and measurement of blood samples.|from baseline to 12 weeks of treatment|The Primary Analysis was done for the sample set of patients with 12 weeks' assessment.|||percentage of change||Standard Deviation|Mean
2649779|NCT01674647|Secondary|Number of Participants With Composite of Major and Non-major Bleeding Events|All events were adjudicated and confirmed by a CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the ISTH criteria. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life. Number of subjects with clinically relevant major and non-major bleeding events were reported.|From randomization up to the date of the last dose of study drug + 2 days|The safety profile was analyzed using the SAF population. SAF population included all randomized subjects who received at least 1 dose of study medication.|||Participants|||Number
2649797|NCT01674634|Secondary|Clinical Success|Clinical success is defined as reduction of FFC of a treated joint to within 0-5 degrees of normal within 30 days of injection|Within 30 days|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. This assessment is based on individual treated joints by joint type.|||Joints|Treated Joints||Number
2649780|NCT01674647|Secondary|Number of Participants With All-cause Mortality|All events were adjudicated and confirmed by a CEC blinded to treatment. All-cause mortality included vascular death and non-vascular death. Number of subjects with all-cause mortality were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.|||Participants|||Number
2649781|NCT01674647|Secondary|Number of Participants With Cardiovascular Deaths|All events were adjudicated and confirmed by a CEC blinded to treatment. Any death that was not clearly non-vascular (e.g., deaths due to spontaneous bleeding, myocardial infarction, stroke, cardiac failure, and arrhythmia). Number of subjects with cardiovascular deaths were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.|||Participants|||Number
2649782|NCT01674647|Secondary|Number of Participants With Myocardial Infarctions|All events were adjudicated and confirmed by a CEC blinded to treatment. MI was assessed based onmeither cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. Number of subjects with MI were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.|||Participants|||Number
2649783|NCT01674647|Secondary|Number of Participants With Non-central Nervous System Systemic Embolisms|All events were adjudicated and confirmed by a CEC blinded to treatment. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). Number of subjects with non-CNS embolism were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.|||Participants|||Number
2649784|NCT01674647|Secondary|Number of Participants With Transient Ischemic Attacks|All events were adjudicated and confirmed by a CEC blinded to treatment. Number of subjects with TIA were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.|||Participants|||Number
2649785|NCT01674647|Secondary|Number of Participants With Strokes|All events were adjudicated and confirmed by a CEC blinded to treatment. Stroke included hemorrhagic (Stroke with local collections of intraparenchymal blood. Subarachnoid hemorrhage, subdural hemorrhage, and epidural hemorrhage were excluded), ischemic infarction (Stroke without focal collection of intracranial blood) and unknown (No imaging data and anatomic findings were available). Number of subjects with strokes were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.|||Participants|||Number
2649786|NCT01674647|Secondary|Number of Participants With Composite of Strokes, Transient Ischemic Attacks, Non-central Nervous System Systemic Embolisms, Myocardial Infarctions and All-cause Mortality|Stroke, TIA, Non- CNS systemic embolism, MI and all-cause mortality were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. All-cause mortality included vascular death and non-vascular death. Number of subjects with composite events were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.|||Participants|||Number
2649787|NCT01674647|Secondary|Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms|Stroke and Non-CNS Embolism were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). Number of subjects with composite events were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the mITT population. mITT population included all the randomized subjects in whom a LA/LAA thrombus was not diagnosed during a TEE performed before the first planned cardioversion in the study.|||Participants|||Number
2649788|NCT01674647|Primary|Number of Participants With Major Bleedings as Per Central Adjudication|Bleeding events were adjudicated and confirmed by CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the International Society on Thrombosis and Hemostasis (ISTH) criteria. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Number of subjects with confirmed adjudicated bleeding events occurring in greater than (>)1 total subjects were reported.|From randomization up to the date of the last dose of study drug + 2 days|The safety profile was analyzed using the safety analysis set (SAF) population. SAF population included all randomized subjects who received at least 1 dose of study medication.|||Participants|||Number
2649789|NCT01674647|Primary|Number of Participants With Composite of the Following Events, Adjudicated Centrally: Stroke, Transient Ischemic Attack, Non-central Nervous System Systemic Embolism, Myocardial Infarction and Cardiovascular Death|Stroke, TIA, Non-CNS Embolism, MI and cardiovascular death were adjudicated and confirmed by Clinical Endpoints Committee (CEC). Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. Cardiovascular death included death in subjects with non-valvular atrial fibrillation (AF). Number of subjects with composite events were reported.|From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment|The primary population for the efficacy analysis was the modified intention-to-treat (mITT) population. mITT population included all the randomized subjects in whom a left atrial/left atrial appendage (LA/LAA) thrombus was not diagnosed during a transesophageal echocardiogram (TEE) performed before the first planned cardioversion in the study.|||Participants|||Number
2649790|NCT01674634|Secondary|Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 61|The URAM scale is a patient-reported functional 9-item scale (total score 0-45) developed and validated to assess functional outcome of patients suffering from Dupuytren's disease with higher scores indicating greater difficulty using the hand.The estimated clinically important change of the URAM scale is 2.9 points. A decrease in total URAM score indicates improvement in hand function.|Baseline, Day 61|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.|||units on a scale|Treated Joint Pairs|Standard Deviation|Mean
2649791|NCT01674634|Secondary|Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 31|The Unité Rhumatologique des Affections de la Main (URAM) scale is a patient-reported functional 9-item scale (total score 0-45) developed and validated to assess functional outcome of patients suffering from Dupuytren's disease with higher scores indicating greater difficulty using the hand.The estimated clinically important change of the URAM scale is 2.9 points. A decrease in total URAM score indicates improvement in hand function.|Baseline, Day 31|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.|||units on a scale|Treated Joint Pairs|Standard Deviation|Mean
2649792|NCT01674634|Secondary|Investigator Assessment of Improvement With Treatment at Day 61|Investigator's determined the degree of improvement in the severity of the subject's treated finger(s) compared with screening at the day 61 follow-up visit.|Day 61|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.|||Joint Pairs|Treated Joint Pairs||Number
2649793|NCT01674634|Secondary|Investigator Assessment of Improvement With Treatment at Day 31|Investigator's determined the degree of improvement in the severity of the subject's treated finger(s) compared with screening at the day 31 follow-up visit.|Day 31|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.|||Joint Pairs|Treated Joint Pairs||Number
2649794|NCT01674634|Secondary|Subject Assessment of Satisfaction With Treatment at Day 61|Subject's were asked to rate satisfaction with treatment at the day 61 follow-up visit|Day 61|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.|||Joint Pairs|Treated Joint Pairs||Number
2649795|NCT01674634|Secondary|Subject Assessment of Satisfaction With Treatment at Day 31|Subject's were asked to rate satisfaction with treatment at the day 31 follow-up visit|Day 31|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.|||Joint Pairs|Treated Joint Pairs||Number
2649796|NCT01674634|Secondary|Clinical Improvement|Clinical improvement is defined as a reduction of FFC by 50% or greater of the baseline value within 30 days of injection|Within 30 days|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. This assessment is based on individual treated joints by joint type.|||Joints|Treated Joints||Number
2649809|NCT01674621|Secondary|Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months||Baseline and 6 months|Modified intent-to-treat population included all patients with pre-treatment and end-of-treatment evaluable DXA assessments. The patients are analyzed as randomized.|||Percent change||Standard Deviation|Mean
2649798|NCT01674634|Primary|Change From Baseline in Total Range of Motion|The total range of motion (ROM) is the sum of the range of motion measurements of the 2 treated joints. ROM is defined as difference between full flexion angle and full extension expressed in degrees. A positive change from baseline indicates increased (improved) ROM.|Baseline, Day 31|Efficacy analysis was based on the mITT population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on the contralateral hand. Assessment is based on simultaneously treated joint pairs.|||degrees|treated joint pairs|95% Confidence Interval|Mean
2649799|NCT01674634|Primary|Percent Change From Baseline in Total Fixed Flexion|Percent change from baseline in total fixed flexion = 100 * (baseline total FFC - day 31 total FFC)/baseline total FFC, where total fixed flexion is defined as the sum of the fixed flexion contracture (FCC) of the 2 joints receiving treatment. Positive percent change from baseline indicates improvement.|Baseline, Day 31|Efficacy analysis was based on the modified intent-to-treat (mITT) population; all enrolled subjects who received both AA4500 injections and had a post-injection efficacy measure. Ten subjects were granted special re-enrollment and had an additional joint pair treated on contralateral hand. Assessment is based on simultaneously treated joint pairs.|||percentage of contracture change|Treated Joint Pairs|Standard Deviation|Mean
2649800|NCT01674621|Secondary|Number of Patients With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4|Coagulation laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: prothrombin time (quick) (Grade 3: 1.51%-2.00%*normal, Grade 4: >2.00%*normal), partial thromboplastin time (Grade 3: 2.34-3.00 seconds [sec], Grade 4: >3.00 secs*normal). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to 6 months|Safety population: All patients who received 1 or more doses of study medication. The patients were analyzed as treated.|||Participants|||Count of Participants
2649801|NCT01674621|Secondary|Number of Patients With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4|Chemistry laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: sodium, potassium, chloride, inorganic phosphorus, albumin, total protein (Grade 3: 4 (+), >1.0 g%, or >10 g/L; Grade 4: nephrotic syndrome), glucose, blood urea nitrogen (BUN), creatinine (Grade 3: 3.1-6.0*normal; Grade 4: >6.0*normal), uric acid, aspartate aminotransferase (AST) (Grade 3: 5.1-20.0 units [U]/L*normal, Grade 4: >20.0 U/L*normal), alanine aminotransferase (ALT) (Grade 3: 5.1-20.0 U/L*normal; Grade 4: >20.0 U/L*normal), gamma-glutamyltranspeptidase (GGT), creatine phosphokinase (CPK), alkaline phosphatase (Grade 3: 5.1-20.0 U/L*normal; Grade 4: >20.0 U/L*normal), total bilirubin (Grade 3: 1.5-3.0*normal; Grade 4: >3.0*normal), lactate dehydrogenase (LDH), cholesterol, triglycerides, total calcium. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to 6 months|Safety population: All patients who received 1 or more doses of study medication. The patients were analyzed as treated.|||Participants|||Count of Participants
2649802|NCT01674621|Secondary|Number of Patients With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4|Hematology laboratory parameters that were evaluated via ECOG Grade 3 and Grade 4 criteria (presented in parentheses) included: white blood cell (Grade 3: 1.0-1.9*10^9/liter [L]; Grade 4 <1.0*10^9/L), platelets (Grade 3: 25.0-49.9*10^9/L; Grade 4: <25.0*10^9/L), haemoglobin (Grade 3: 65.0-79.0 grams [g]/L or 4.0-4.9 mmol/L; Grade 4: <65.0 g/L or <4.0 millimole [mmol]/L), granulocytes/bands (Grade 3: 0.5-0.9*10^9/L; Grade 4: <0.5*10^9/L), lymphocytes (Grade 3: 0.5-0.9*10^9/L; Grade 4: <0.5 *10^9/L), haemorrhage (Grade 3: gross, 3 - 4 units transfusion per episode; Grade 4: massive, > 4 units transfusion per episode). A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to 6 months|Safety population: All patients who received 1 or more doses of study medication. The patients were analyzed as treated.|||Participants|||Count of Participants
2649803|NCT01674621|Secondary|Number of Patients With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result|The following ECG parameters were recorded: rhythm, heart rate, PR interval, QRS duration and QT/QTc. ECG results that were considered clinically meaningful were to be determined by the Investigator. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to 7 months|Safety population: All patients who received 1 or more doses of study medication. The patients were analyzed as treated.|||Participants|||Count of Participants
2649804|NCT01674621|Secondary|Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes|Vital sign parameters included respiration rate (breaths/minute), body temperature (°C), systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg), and heart rate (bpm). Number of patients for each TEAE is presented. The same patient may be included in more than one TEAE category. A summary of other non-serious adverse events (AEs) and all serious AEs, regardless of causality is located in Reported AE section.|Baseline up to 7 Months|Safety population: All patients who received 1 or more doses of study medication. The patients were analyzed as treated.|||participants|||Number
2649805|NCT01674621|Secondary|Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)||Screening and 6 Months|Safety population: All patients who received 1 or more doses of study medication. The patients were analyzed as treated.|||participants|||Number
2649806|NCT01674621|Secondary|Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTX) at 6 Months||Baseline and 6 months|Modified intent-to-treat population included all patients with pre-treatment and end-of-treatment evaluable DXA assessments. The patients are analyzed as randomized.|||Percent change||Standard Deviation|Mean
2649807|NCT01674621|Secondary|Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months||Baseline and 6 months|Modified intent-to-treat population included all patients with pre-treatment and end-of-treatment evaluable DXA assessments. The patients are analyzed as randomized.|||Percent change||Standard Deviation|Mean
2649808|NCT01674621|Secondary|Percent Change From Baseline in Serum Osteoclacin at 6 Months||Baseline and 6 months|Modified intent-to-treat population included all patients with pre-treatment and end-of-treatment evaluable DXA assessments. The patients are analyzed as randomized.|||Percent change||Standard Deviation|Mean
2674986|NCT01451398|Secondary|Severe Hypoglycemia Event Rate|Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 24|Safety population|||Events/100 Subject-Month|||Number
2649811|NCT01674621|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of Forearm at 6 Months|Percent Change from Baseline in BMD of Forearm at 6 Months, using DXA results; active compared to placebo.|Baseline and 6 months|Modified intent-to-treat population included all patients with pre-treatment and end-of-treatment evaluable DXA assessments. The patients are analyzed as randomized.|||Percent change||Standard Deviation|Mean
2649812|NCT01674621|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at 6 Months||Baseline and 6 months|Modified intent-to-treat population included all patients with pre-treatment and end-of-treatment evaluable DXA assessments. The patients are analyzed as randomized.|||Percent change||Standard Deviation|Mean
2649813|NCT01674621|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months||Baseline and 6 months|Modified intent-to-treat population included all patients with pre-treatment and end-of-treatment evaluable DXA assessments. The patients are analyzed as randomized.|||Percent change||Standard Deviation|Mean
2649814|NCT01674569|Primary|Change From Baseline Visual Acuity at 6 Months|"The best corrected visual acuity by the Early Treatment Diabetic Retinopathy Study (ETDRS) method was determined at baseline and at various times during the study. The ETDRS method records the number of letters of decreasing size on a chart that a subject can read from a defiend distance.~During the study the ETDRS visual acuity was used to monitor the need for rescue therapy. The primary endpoint of the study was the change from baseline visual ETDRS visual acuity at 6 months. It was calculated by subtracting the baseline visual acuity from the visual acuity at 6 months for each individual subject. A positive change from baseline indicates improvement in visual acuity."|6 months|The mean and standard deviation was calculated for all subjects who completed 6 months of treatment with oral X82|||number of letters||Standard Deviation|Mean
2649815|NCT01674478|Primary|The Serum Biomarkers of Oxidative Stress|Compare the serum biomarkers of oxidative stress of the infants receiving ML/FO to the infants only receiving ML between the initial feeding after placement of an ostomy and reanastomosis|2 years and 5 months|No data collected||||||
2649816|NCT01674478|Secondary|The Average Weight Gain (g/Day) After Reanastomosis|To compare the the average weight gain (g/day) of infants receiving ML/FO to the infants only receiving ML after reanastomosis|2 years and 5 months||||g/d||Standard Deviation|Mean
2649817|NCT01674478|Secondary|The Average Enteral Calorie (Total Calorie) Intake Before Reanast|To compare the average enteral calorie (total calorie) intake of infants receiving ML/FO to the group only receiving ML between the initial feeding after placement of an ostomy and reanastomosis|2 years and 5 months||||kcal/kg/day||Standard Deviation|Mean
2649818|NCT01674478|Primary|The Serum Biomarkers of Inflammatory Cytokines|Compare the serum biomarkers of inflammatory cytokines of the infants receiving ML/FO to the infants only receiving ML between the initial feeding after placement of an ostomy and reanastomosis|2 years and 5 months|No data collected||||||
2649819|NCT01674062|Secondary|Cohorts 1 and 2: Overall Survival (OS)|Participants were followed for survival data during and after treatment for a maximum of 3 years after the last dose until death, withdrawal of consent, or loss to follow-up. OS was defined as the time from first dose to the time of death from any cause. Participants who did not experience death were censored at the last known alive date. OS was estimated using Kaplan-Meier and expressed in months.|Up to approximately 4.5 years (during treatment; then every 4 months until death, withdrawn consent, loss to follow-up, or 3 years after last dose; final analysis using November 2010 cutoff date)|All Treated Population (Cohorts 1 and 2 only).|||months||80% Confidence Interval|Median
2649820|NCT01674062|Secondary|Cohorts 1 and 2: Percentage of Participants Who Died|Participants were followed for survival data during and after treatment for a maximum of 3 years after the last dose until death, withdrawal of consent, or loss to follow-up. The percentage of participants who died was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.|Up to approximately 4.5 years (during treatment; then every 4 months until death, withdrawn consent, loss to follow-up, or 3 years after last dose; final analysis using November 2010 cutoff date)|All Treated Population (Cohorts 1 and 2 only).|||percentage of participants|||Number
2649821|NCT01674062|Secondary|Cohorts 1 and 2: Progression-Free Survival (PFS) According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to assess for disease progression, defined as at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. PFS was defined as the time from first dose to the time of disease progression or death. Participants without progression or death were censored at the last tumor assessment. PFS was estimated using Kaplan-Meier analysis and expressed in weeks.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).|||weeks||80% Confidence Interval|Median
2649822|NCT01674062|Secondary|Cohorts 1 and 2: Time to Progression (TTP) According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to assess for disease progression, defined as at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. TTP was defined as the time from first dose to the time of first documented disease progression. Participants who withdrew from the study without documented progression were censored at the last tumor assessment. TTP was estimated using Kaplan-Meier analysis and expressed in weeks.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).|||weeks||Full Range|Median
2649823|NCT01674062|Secondary|Cohorts 1 and 2: Percentage of Participants With Disease Progression According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to assess for disease progression, defined as at least a 20% increase in the sum of the longest diameter, taking as reference the smallest sum of the longest diameter observed at previous tumor assessment, or the appearance of any new lesions. The percentage of participants with disease progression was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).|||percentage of participants|||Number
2649824|NCT01674062|Secondary|Cohorts 1 and 2: Time to Objective Response According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to determine the OR rate. Time to response was defined as the time from first dose to the time of initial response of CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. Participants with disease progression were censored at the time of progression, and those with neither disease progression nor OR were censored at the last tumor assessment. Time to response was estimated using Kaplan-Meier analysis and expressed in weeks.|Up to approximately 21 months (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression; final analysis using February 2008 cutoff date)|All Treated Population (Cohorts 1 and 2 only).|||weeks||Full Range|Median
2649825|NCT01674062|Secondary|Cohorts 1 and 2: Duration of Response According to RECIST Version 1.0|Tumor response was assessed using RECIST version 1.0 to determine OR and CBR rates. Duration of OR was defined as time from initial response of CR or PR to time of disease progression or death. Duration of CBR was defined similarly as time from initial response of CR or PR, or SD lasting at least 6 months, to time of disease progression or death. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Participants without progression or death following confirmed CR or PR were censored at the last tumor assessment. Duration of response was estimated using Kaplan-Meier analysis and expressed in weeks.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).|||weeks||Full Range|Median
2649826|NCT01674062|Secondary|Cohort 3: Percentage of Participants With a Confirmed Best Overall Response of CR, PR, or SD According to RECIST Version 1.0 During Single-Agent Treatment With Pertuzumab|Tumor response was assessed using RECIST version 1.0 to determine the CBR rate, or the percentage of participants with either confirmed CR or PR, or SD lasting at least 6 months. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The CBR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 7.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohort 3 only).|||percentage of participants||80% Confidence Interval|Number
2649827|NCT01674062|Secondary|Cohort 3: Percentage of Participants With a Confirmed Best Overall Response of CR or PR According to RECIST Version 1.0 During Single-Agent Treatment With Pertuzumab|Tumor response was assessed using RECIST version 1.0 to determine the OR rate, or the percentage of participants with either confirmed CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The OR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 7.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohort 3 only).|||percentage of participants||80% Confidence Interval|Number
2649828|NCT01674062|Primary|Cohorts 1 and 2: Percentage of Participants With a Confirmed Best Overall Response of CR, PR, or Stable Disease (SD) According to RECIST Version 1.0 During Dual-Agent Treatment|Tumor response was assessed using RECIST version 1.0 to determine the clinical benefit response (CBR) rate, or the percentage of participants with either confirmed CR or PR, or SD lasting at least 6 months. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30% decrease in the sum of the longest diameter compared to Baseline. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient (20%) increase to qualify for disease progression, in addition to no new target lesions. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The CBR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).|||percentage of participants||80% Confidence Interval|Number
2649829|NCT01674062|Primary|Cohorts 1 and 2: Percentage of Participants With a Confirmed Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 During Dual-Agent Treatment|Tumor response was assessed using RECIST version 1.0 to determine the objective response (OR) rate, or the percentage of participants with either confirmed CR or PR. CR was defined as the disappearance of all target lesions, and PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter compared to Baseline. Response was to be confirmed a minimum of 4 weeks after the initial response was documented. The OR rate was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|Up to approximately 9.5 years (at Screening; on Day 15 of Cycles 2, 4, 6, and 8 [cycle length 3 weeks]; then every 3 months until disease progression)|All Treated Population (Cohorts 1 and 2 only).|||percentage of participants||80% Confidence Interval|Number
2649830|NCT01674010|Secondary|Time to Recurrence of a Manic/Hypomanic or a Mixed Episode||up to 48 weeks|Study was prematurely terminated, no data were collected for this Outcome Measure||||||
2649831|NCT01674010|Secondary|Time to Recurrence of a Depressive Episode||up to 48 weeks|Study was prematurely terminated, no data were collected for this Outcome Measure||||||
2649832|NCT01674010|Secondary|Proportion of Study Participants With Recurrence of Any Mood Episode||up to 48 weeks|Study was prematurely terminated, no data were collected for this Outcome Measure||||||
2649833|NCT01674010|Primary|Treatment Emergent Adverse Events|The study was terminated early so no efficacy analysis was done, safety data are reported.|up to 48 weeks|TEAEs reported for Phase 2 were from the entire study period|||participants|||Number
2649834|NCT01673984|Secondary|Percentage of Participants Who Changed Injection Frequency After Completion of the Study||Month 12|Analysis based on the number of subjects with a valid value in the ITT population which comprised of 21 patients.|||percentage of participants|||Number
2649835|NCT01673984|Secondary|Patient Satisfaction With Treatment.|Using a non-validated study-specific descriptive Likert-type scale (with no units) comprising a simple six-question patient questionnaire.|Month 12|No participant analysis as no data was collected due to low number of participants recruited in the study.||||||
2649836|NCT01673984|Secondary|Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II)|TSQM comprised of four dimensions: effectiveness, side effects, convenience and overall global satisfaction. Each score ranged from 0 to 100. For effectiveness, convenience and overall global satisfaction scores, 0 indicated an extreme dissatisfaction and 100 indicated an extreme satisfaction. For side effects score, 0 indicated an extreme dissatisfaction and 100 indicated no dissatisfaction at all.|6 and 12 month|Analysis based on the number (n) of subjects with a valid value in each arm of the ITT population which comprised of 21 patients.|||units on a scale||95% Confidence Interval|Mean
2649837|NCT01673984|Secondary|Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire.|The EQ-5D-5L questionnaire consisted of a description of raw data which comprised of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension had five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogical scale of the EQ-5D-5L questionnaire was numbered from 0 to 100 (0 meaning the worst health the patient can imagine and 100 the best health the patient can imagine).|Baseline and Month 12|Analysis based on the number of subjects with a valid value in the ITT population which comprised of 21 patients.|||units on a scale||95% Confidence Interval|Mean
2649838|NCT01673984|Secondary|Percentage of Participants Demonstrating Stable Prostate-specific Antigen (PSA) Levels|Stable PSA level was noted as value either lower or less than 25% higher than the baseline value, or PSA value ≤0.5 ng/mL higher than the baseline value, if value ≥25% higher than the baseline value.|6 and 12 months|Analysis based on number (n) of patients with a valid value in the intent-to-treat (ITT) population which comprised of 21 patients.|||percentage of participants|||Number
2649839|NCT01673984|Secondary|Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment.|Patients with serum total testosterone (STT) level lower than 0.5 ng/mL, 12 months after randomisation..|12 months|Analysis based on the number of subjects with a valid value in the ITT population comprised of 21 patients.|||percentage of participants|||Number
2649840|NCT01673984|Primary|Percentage of Participants Maintaining Biochemical Castration|Patients with serum total testosterone (STT) level lower than 0.5 ng/mL after 6 months of treatment.|6 months|Analysis based on intent-to-treat (ITT) population comprised of 21 patients.|||percentage of participants|||Number
2649841|NCT01673919|Secondary|Parent/Patient's Discomfort Index (Pain)|Participants or parents rated participant's pain by placing a horizontal line on a VAS of 0 (no pain) - 100 mm (unbearable pain). To describe the pain, a cut-off at 10 mm was used, and VAS <10 mm was defined as no pain.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||mm||Standard Deviation|Mean
2649842|NCT01673919|Secondary|Parent/Patient's Global Assessment of Disease Activity|Parent/patient global assessment of disease activity was performed using 0 to 100 mm VAS, and higher the score of VAS, worse the disease status (0= absence of activity or sign or symptom; 100= maximal activity or signs or symptoms). No disease activity was defined as VAS <=10 mm.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||mm||Standard Deviation|Mean
2649843|NCT01673919|Secondary|Physician's Global Assessment of Disease Activity|The Physician's global assessment of disease activity was recorded on a 0 to 100 mm horizontal VAS where score 0 represented 'arthritis inactive' (i.e., symptom-free and no arthritis symptoms) and score 100 represented 'arthritis very active' (higher score indicate worsening of disease).|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||millimeter (mm)||Standard Deviation|Mean
2649844|NCT01673919|Secondary|Number of Painful Joints|The painful joints were counted by physical examination and mean painful joints was reported.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||joints||Standard Deviation|Mean
2649845|NCT01673919|Secondary|Number of Swollen Joints|The swollen joints was counted by physical examination and mean swollen joints were reported.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||joints||Standard Deviation|Mean
2649846|NCT01673919|Secondary|Number of Joints With Active Range of Motion|The active range of motion joints was counted by physical examination and mean joints was reported.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||joints||Standard Deviation|Mean
2649847|NCT01673919|Secondary|Number of Joints With Limitation of Motion|The most frequent symptom reported by most participants was a limitation of motion (LOM) of joints and it was determined by physical examination. The mean joints with limitation of motion were reported.|Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||joints||Standard Deviation|Mean
2649890|NCT01673646|Secondary|Change of Tumor Volume From Baseline|This shows the change in tumor volume from baseline to month 6 and from baseline to month 12 in patients treated with pasireotide LAR.|Baseline, Months 6 , 12|FAS: Comprises all patients to whom study treatment has been assigned by randomization. Protocol allowed to change treatment dose (eg, 20mg -> 40mg ->20mg -> 40mg ->60mg) based on efficacy and safety after 3month treatment. So we combined Arms/groups.|||mm^3||Full Range|Median
2649848|NCT01673919|Secondary|Number of Participants With a Minimally Important Improvement in the Childhood Health Assessment Questionnaire-Disability Index|The CHAQ-DI included questions on dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. The disability index (DI) of the original CHAQ was graded on 4-point categorical scales of 30 items grouped into 8 domains of physical function. The highest scoring item in each domain determined the score for that domain. The score for the disability index was the mean of domain scores ranging from 0 to 3 (0 = without any difficulty and 3 = unable to do) with higher scores meaning higher disability. Minimally important improvement in CHAQ-DI was defined as a change from baseline of WA19977 core study (Day 1/Visit 1) >=0.13 at each visit.|Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all the participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||participants|||Number
2649849|NCT01673919|Secondary|Number of Participants Achieving Clinical Remission|Clinical remission was defined as inactive disease observed for at least 6 continuous months. Clinical remission was defined as per medication uptake as: Level 1 (clinical remission on medication), Level 2 (clinical remission off oral corticosteroid medication [still on TCZ]), Level 3 (clinical remission off both oral corticosteroid and methotrexate medication [still on TCZ]), and Level 4 (clinical remission off all anti-inflammatory medications [still on TCZ]). Number of participants at each clinical remission level was reported.|Weeks 24, 36, 48, 72, and 108|The ITT population included all participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||participants|||Number
2649850|NCT01673919|Secondary|Number of Participants With Inactive Disease|Inactive disease was defined as: 1) No joints with active arthritis (no swollen, painful and lack of motion joints), 2) No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA, 3) No active uveitis, 4) ESR and/or CRP within normal range, and 5) No disease activity according to Physician's global assessment of disease activity (<= 10 millimeters [mm] on a VAS). The participant's treating physician provided a rating of the participant's arthritis disease activity on a 0 to 100 mm horizontal scale where score 0 represented 'arthritis inactive' (i.e., symptom-free and no arthritis symptoms) and score 100 represented 'arthritis very active'.|Weeks 24, 36, 48, 72, and 108|The ITT population included all participants who had at least one efficacy assessment. n = number of participants analyzed for the given parameter at the specified visit.|||participants|||Number
2649851|NCT01673919|Secondary|Number of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology Response 50/70|The Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) is comprised of six components: Maximum number of joints with active arthritis; Number of joints with limitation of movement; Erythrocyte Sedimentation Rate (ESR) and/or C-reactive Protein (CRP); Childhood Health Assessment Questionnaire-Disease Index (CHAQ-DI) graded on 4-point scales [0 = without any difficulty and 3 = unable to do] of 30 items grouped into 8 domains of physical function; Physician's global assessment of disease activity and Participant's global assessment of overall well-being (both assessed on a 0 to 100 mm Visual Analogue Scale [VAS], where score 0 = inactive arthritis and 100 = very active arthritis). A JIA ACR50/70 response is defined as improvement in at least three of the six core components by at least 50 percent (%), or 70%, respectively and no more than one of the remaining core components worsening by more than 30%.|Weeks 12, 24, 36, 48, 60, 72, 84, and 108|The ITT population included all participants who had at least one efficacy assessment. Number (n) = number of participants analyzed for the given parameter at the specified visit.|||participants|||Number
2649852|NCT01673919|Secondary|Number of Participants With Abnormality in Physical Examinations|Participants with abnormal physical examinations of ear, nose and throat (asthma); extremities (synovitis, sequelae with flexion of the 5th right proximal interphalangeal joint, hallux valgus, deviations of metatarsophalangeal joints, and callus under metatarsal head); lung (mild bronchospasm); skin (vitiligo and hematoma, fatty subcutaneous infiltration on the neck, cutaneous eruption, and scalp pediculosis); and musculoskeletal system (discomfort in right hip) were reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.|||participants|||Number
2649853|NCT01673919|Secondary|Number of Participants With Clinically Significant Abnormal Laboratory Parameters|Clinically significant abnormal parameters included eosinophil count, alanine aminotransferase, total bilirubin, and protein and blood in urine. Number of participants with these abnormal lab parameters was reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.|||participants|||Number
2649854|NCT01673919|Secondary|Number of Participants With AEs Leading to TCZ Modification, AEs Leading to Death, Anaphylaxis or Serious Hypersensitivity and Deaths|Number of participants with AEs leading to TCZ modification, AEs leading to death, anaphylaxis or serious hypersensitivity, and deaths were reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.|||participants|||Number
2649855|NCT01673919|Secondary|Mean Duration of Study Follow-Up|The participants were followed-up from Day 1 to last visit date (approximately 2 years). Mean time for which participants were followed up in the study was reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.|||Months||Standard Deviation|Mean
2649856|NCT01673919|Secondary|Mean Exposure to Study Treatment|Participants received TCZ for Week 104 or when TCZ was commercially available for pcJIA participants, whichever comes first in France. The mean TCZ exposure (time from first to last administration) was reported.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.|||Months||Standard Deviation|Mean
2649857|NCT01673919|Primary|Number of Participants With Adverse Events Related to Tocilizumab|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. Relatedness of any AEs was reported as possibly related, probably related, or remotely related to TCZ.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.|||participants|||Number
2649891|NCT01673646|Secondary|Summary of Pasireotide LAR PK Parameter of Accumulation Ratio Randomized Dose Level|The accumulation ratio was calculated as a ratio of (Ctrough day28, 3rd injection/Ctrough day28, 1st injection).|Day 28 after injections 1 and 3|PAS: Consists of full analysis set (FAS) who have evaluable PK concentration data|||ratio||Standard Deviation|Mean
2649858|NCT01673919|Primary|Number of Participants With Adverse Events of Special Interest|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. The AEs of special interests included gingival bleeding, tooth abscess, acarodermatitis, ear infection, gastroenteritis, herpes zoster ophthalmic, lice infestation, nasopharyngitis, oral fungal infection, oral herpes, pharyngitis, rhinitis, sinusitis, tonsillitis, tracheitis, tracheobronchitis, urinary tract infection, menorrhagia, asthma, epistaxis, and hematoma.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.|||participants|||Number
2649859|NCT01673919|Primary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Approximately 2 years|Safety population included all participants who received at least a single dose of study drug.|||participants|||Number
2649860|NCT01673893|Primary|30 Day Readmissions|Collecting data for STEMI and NSTEMI patients for 30 day readmissions after the STEMI or NSTEMI with use of the clearway catheter during the procedure.|30 Days|The above documentation shows the number of readmissions within 30days of post PCI with 7 subjects. The number of cardiovascular Admissiosn within 30 days that were not preplanned or elective are 3. The number of subjects compliant with the dual anti platelet therapy consists of 59 subjects who completed the study.|||participants|||Number
2649861|NCT01673867|Secondary|Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2649862|NCT01673867|Primary|Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint|The number of participants who died from any cause was reported for each arm. Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants|||participants|||Number
2649863|NCT01673867|Secondary|Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|Overall Survival time was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants|||months||95% Confidence Interval|Median
2649864|NCT01673867|Secondary|Percentage of Participants Experiencing Disease-related Symptom Improvement by Week 12|Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.|Randomization to Week 12|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2649865|NCT01673867|Primary|One-year Overall Survival (OS) Rate in All Randomized Participants|The one-year overall survival rate is a percentage, representing the fraction of all randomized participants who were alive following one year of treatment. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.|12 months|All Randomized Participants|||percentage of participants||95% Confidence Interval|Number
2649866|NCT01673867|Secondary|Progression-Free Survival (PFS) Time in Months for All Randomized Participants at Primary Endpoint|PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. Participants underwent radiographic tumor assessments every 6 weeks (+/- 5 days) from week 9 (+/- 5 days) for the first year on treatment, then every 12 weeks after the first year on treatment until documented disease progression. The PFS curves were estimated using KM method. Two-sided 95% CIs for median PFS were computed by Brookmeyer and Crowley method (using log-log transformation). Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants|||months||95% Confidence Interval|Median
2649867|NCT01673867|Secondary|Progression-Free Survival (PFS) Rate at 12 Months|PFS rate was defined as the percentage of participants experiencing no disease progression or death from any cause at 12 months after randomization. Progression was assessed by investigators according to RECIST v1.1. 95% CIs were estimated using the Kaplan-Meier method.|Randomization to 12 months|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2674987|NCT01451398|Secondary|Total Hypoglycemia Event Rate|Number of Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 24|Safety population|||Events/Subject-Month|||Number
2649868|NCT01673867|Secondary|Time To Response (TTR) in Months for All Confirmed Responders at Primary Endpoint|Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.|Randomization until confirmed response, up to March 2015 (approximately 29 months)|All randomized participants who demonstrate partial response or complete response|||months||Full Range|Median
2649869|NCT01673867|Secondary|Duration of Objective Response (DOR) in Months for All Confirmed Responders at Primary Endpoint|"DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR).~CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.~Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment."|Date of confirmed response to date of documented tumor progression or death, up to March 2015 (approximately 29 months)|All randomized participants who demonstrate partial response (PR) or complete response (CR).|||months||Full Range|Median
2649870|NCT01673867|Secondary|Objective Response Rate (ORR) in All Randomized Participants at Primary Endpoint|"ORR was defined as the percentage of participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first.~CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method."|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All Randomized Participants|||percentage of participants||95% Confidence Interval|Number
2649871|NCT01673867|Primary|Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint|OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.|Randomization until 413 deaths, up to March 2015 (approximately 29 months)|All randomized participants|||months||95% Confidence Interval|Median
2649872|NCT01673854|Other Pre-specified|Number of Participants With Adverse Events (AEs) Grade 3-4, Related AEs Grade 3-4, Related Serious Adverse Events (SAEs) Grade 3-4, Immune-related (ir) AEs Grade 3-4, and Serious irAEs Grade 3-4|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of study drug|||Participants|||Number
2649873|NCT01673854|Other Pre-specified|Number of Participants Who Died, Who Died Due to Related Adverse Events (AEs), and With Related AEs, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to AEs and Related AEs, Immune-related (ir) AEs, and Serious irAEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of study drug|||Participants|||Number
2649874|NCT01673854|Secondary|Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Hepatobiliary Adverse Events|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Drug-related=having certain, probable, possible, or unknown relationship to study drug. Grading criteria for AEs: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of vemurafenib and ipilimumab|||Percentage of participants||95% Confidence Interval|Number
2649875|NCT01673854|Secondary|Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Gastrointestinal Adverse Events (AEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Drug-related=having certain, probable, possible, or unknown relationship to study drug. Grading criteria for AEs: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of ipilimumab.|||Percentage of participants||95% Confidence Interval|Number
2649931|NCT01673347|Secondary|Range of Motion Dorsiflexion|Range of Motion Dorsiflexion|3-months postoperative|17 participants available to analyze at 3 months due to early allograft failure in 7 participants|||degrees||Standard Deviation|Mean
2649876|NCT01673854|Primary|Percentage of Participants Who Received Ipilimumab and Who Had Grade 3-4 Drug-related Skin Adverse Events (AEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Drug-related=having certain, probable, possible, or unknown relationship to study drug. Grading criteria for AEs: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death.|From the first dose date of Vem1 to the last dose of ipilimumab (to a maximum of 3 years) + 90 days or to the first dose date of Vem2, whichever occurred first|All participants who received at least 1 dose of ipilimumab|||Percentage of participants||95% Confidence Interval|Number
2649877|NCT01673828|Primary|Extended Glasgow Outcome Scale (GOS-E) Score|GOS-E is a global scale for functional outcome that rates patient status into one of 8 levels. The minimum score is 1 and the maximum score is 8. 1 = dead; 2 = vegetative state; 3 = low severe disability; 4 = upper severe disability; 5 = low moderate disability; 6 = upper moderate disability; 7 = low good recovery; 8 = upper good recovery. GOS-E was assessed by 19 question structured interview.|6 months after injury||||GOS-E Score||Standard Deviation|Mean
2649878|NCT01673802|Primary|Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT|CT scans were assessed for tumor visualization after use of Gadoxetate disodium|24 hrs|Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT|||participants|||Number
2649879|NCT01673698|Secondary|Weight Loss Maintenance Six Months Following Device Removal|Assess whether significantly greater than 50% of treatment subjects maintained 40% of their excess weight loss at 48 weeks.|48 weeks|By design, this trial only studied weight loss maintenance at 48 weeks of the Treatment Group who initially received a balloon during the first 24 weeks of the study.|||percentage of participant|||Number
2649880|NCT01673698|Primary|Treatment Group Responder Rate Dichotomized at 25% EWL|An inferential test of whether the percentage of participants in the Treatment Group with a weight loss of >25% EWL at 24 weeks was significantly greater than 35%.|24 weeks|By design, this trial only studied the weight loss responder rate of the Treatment Group subjects during the first 24 weeks of the study.|||percentage of participants|||Number
2649881|NCT01673698|Primary|Comparison of Treatment % Excess Weight Loss (EWL) With Control %EWL at Week 24|An inferential test of whether the difference in the mean %EWL between the Treatment and Control groups at 24 weeks was significantly greater than a superiority margin 7.5%.|Week 24||||percentage of EWL||Standard Error|Mean
2649882|NCT01673646|Secondary|Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase)|This shows a change of mean GH levels and somatostatin analogues (SSAs) from baseline in extension phase|Baselnine, Months 2.75, 3, 6, 9, 12, 18, 24|FAS: Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.|||ug/L||Full Range|Median
2649883|NCT01673646|Secondary|Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Extension Phase)|Percentage of participants with the normalization of IGF-1 to within normal limits (age and sex related) at 18 and 24 months of study. treatment|Months 18, 24|FAS: Comprises all patients to whom study treatment has been assigned by randomization. The protocol allowed frequent dose changes even extension phase. In this case, separate data is not meaningful.|||Percentage of participants||95% Confidence Interval|Number
2649884|NCT01673646|Secondary|Percentage of Overall Participants With the Reduction of Mean GH Levels to <2.5 ug/L by Visit (Extension Phase)|Percentage of participants with a reduction of mean GH levels to < 2.5µg/L at 18 and 24 months of study treatment|Months 18, 24|FAS: Comprises all patients to whom study treatment has been assigned by randomization. The protocol allowed frequent dose changes even extension phase. In this case, separate data is not meaningful.|||Percentage of participants||95% Confidence Interval|Number
2649885|NCT01673646|Secondary|Total-group Response Rate by Visit (Extension Phase)|Percentage of participants with a reduction of mean GH levels to < 2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) a18 and 24 months of study treatment.|Months 18, 24|FAS: Comprises all patients to whom study treatment has been assigned by randomization. The protocol allowed frequent dose changes even extension phase. In this case, separate data is not meaningful.|||Percentage of participants||95% Confidence Interval|Number
2649886|NCT01673646|Secondary|Change From Baseline in Prolactin|Change in prolactin levels from baseline|Baseline, Months 3, 6, 9, 12|FAS: Comprises all patients to whom study treatment has been assigned by randomization. Protocol allowed to change treatment dose (eg, 20mg -> 40mg ->20mg -> 40mg ->60mg) based on efficacy and safety after 3month treatment. So we combined Arms/groups.|||pmol/L||Full Range|Median
2649887|NCT01673646|Secondary|Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase)|Number of participants with a change of clinical signs from baseline (BL): headache (HA), fatigue (FA), perspiration (PE), paresthesias (PA), osteoarthralgia (OS)|12 Months (Core phase)|Full analysis set (FAS) comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.|||Participants|||Count of Participants
2649888|NCT01673646|Secondary|Change in Ring Size From Baseline|Change of clinical signs from baseline: ring size. In Japan, ring sizes are specified using a numerical scale, that only has whole sizes, and does not have simple linear correlation with diameter or circumference. Only numbers are used ranging from 1 to 27. For instance, a ring size of 1 in Japan is equivalent to an inside circumference ring size of 38.86 mm and a ring size of 27 in Japan is equivalent to an inside circumference ring size of 70.15 mm.|Baseline, Months 3, 6, 9, 12|FAS: Comprises all patients to whom study treatment has been assigned by randomization. Protocol allowed to change treatment dose (eg, 20mg -> 40mg ->20mg -> 40mg ->60mg) based on efficacy and safety after 3month treatment. So we combined Arms/groups.|||other - Japanese ring size number||Full Range|Median
2649889|NCT01673646|Secondary|Change in Mean GH Levels From Baseline|This shows the change in mean GH levels from baseline in median GH levels by visit.|Baseline, Months 2.75, 3, 6, 9, 12, 18, 24|FAS: Comprises all patients to whom study treatment has been assigned by randomization. Protocol allowed to change treatment dose (eg, 20mg -> 40mg ->20mg -> 40mg ->60mg) based on efficacy and safety after 3month treatment. So we combined Arms/groups.|||ug/L||Full Range|Median
2649892|NCT01673646|Secondary|Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level|"Ctrough: The trough level concentration on day 28, 3 months post 1st, 2nd and 3rd injections of Pasireotide LAR.~Cmax: The maximum concentration 3 months post the 1st injection and 3rd injection of LAR."|Ctrough: Day 28 after each injection 1-3, Cmax: 3 months after injections 1 and 3|The pharmacokinetic (PK) analysis set (PAS) consists of full analysis set (FAS) who have evaluable PK concentration data.|||ng/mL||Standard Deviation|Mean
2649893|NCT01673646|Secondary|Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Core Phase)|This refers to the percentage of participants with the normalization of insulin-like growth factor-1 (IGF-1) to within normal limits by visit.|Months 3, 6, 9, 12|FAS: Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.|||Percentage of participants||95% Confidence Interval|Number
2649894|NCT01673646|Secondary|Percentage of Overall Participants With the Reduction of GH Levels to <2.5 ug/L by Visit (Core Phase)|This refers to the percentage of participants with a reduction of growth hormone (GH) response rates to <2.5 ug/L over time.|Months 3, 6, 9, 12|FAS: Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.|||Percenage of participants||95% Confidence Interval|Number
2649895|NCT01673646|Secondary|Total-group Response Rate (GH & IGF-1) Over Time (Core Phase)|Percentage of participants with a reduction of mean GH levels to < 2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) at 3, 6, 9 and 12 months|Months 3, 6, 9 & 12|FAS: Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.|||Percentage of participants||95% Confidence Interval|Number
2649896|NCT01673646|Secondary|IGF-1 Response at Month 3 by Randomized Dose|Percentage of participants with the normalization of IGF-1 to within normal limits (age and sex related) at 3 months.|Month 3|FAS: Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.|||Percentage of participants||95% Confidence Interval|Number
2649897|NCT01673646|Secondary|GH Response at Month 3 by Randomized Dose|Percentage of participants with a reduction of mean GH levels to < 2.5 µg/L at 3 months.|Month 3|FAS: Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.|||Percentage of participants||95% Confidence Interval|Number
2649898|NCT01673646|Secondary|Response Rate at Month 3 by Randomized Dose Level|Percentage of participants with a reduction of mean GH levels to < 2.5 µg/L and the normalization of IGF-1 to within normal limits (age and sex related) at 3 months in each starting dose.|Month 3|FAS: Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.|||Percentage of participants||95% Confidence Interval|Number
2649899|NCT01673646|Primary|Total-group Response Rate at Month 3|Percentage of participants with a reduction of mean growth hormone (GH) levels to < 2.5 µg/L and the normalization of insulin-like growth factor-1 (IGF-1) to within normal limits (age and sex related) at 3 months across all doses|Month 3|The Full analysis Set (FAS): Comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.|||Percentage of participants||95% Confidence Interval|Number
2649900|NCT01673620|Primary|Number of Participants Discontinuing Study Treatment Due to AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.|Up to 2 weeks|The APaT population consisted of all randomized participants who received at least one dose of study drug.|||participants|||Number
2649901|NCT01673620|Primary|Number of Participants Experiencing at Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.|Up to 4 weeks|The All-Patients-as-Treated (APaT) population consisted of all randomized participants who received at least one dose of study drug.|||participants|||Number
2649902|NCT01673594|Primary|Safety|Number of adverse events throughout the course of the study|6 Weeks||||adverse events||Standard Deviation|Mean
2649903|NCT01673594|Primary|Change in Score on AISRS From Baseline to Week 6|The Adult ADHD Investigator System Report Scale (AISRS) is an 18-item, DSM-IV symptom Likert scale that measures ADHD symptoms in adults. Each of the individual symptoms of ADHD is rated from 0 to 3 on a scale of severity (3 being more severe symptoms). Total scores range from 0 to 54; higher scores indicate greater symptom severity. Change was calculated as value at baseline minus value at 6 weeks.|Baseline and 6 Weeks||||units on a scale||Standard Deviation|Mean
2649904|NCT01673568|Secondary|Seroma Formation|Seroma formation measured on day 7 postoperatively with trans abdominal ultrasound scan (US). The method used in this study to estimate the volume of seroma is to measure the longitudinal section and cross section of the effusion and thereby calculating the volume.|postoperative day 7||||mL||Full Range|Median
2649905|NCT01673568|Primary|Visual Analog Scale of Pain Activity|Outcome is based on patient self-reported registrations using Visual Analog Scales (VAS) where 0 is no pain in activity and 100 is worst imaginable pain in activity.|24 hours after hernia repair||||units on a scale||Full Range|Median
2649906|NCT01673490|Secondary|Change From Baseline in Maximum Rate of Urinary Flow (Qmax) at the Indicated Time Points|The Qmax is used as an indicator for the diagnosis of enlarged prostate. A lower Qmax may indicate that the enlarged prostate. Qmax was assessed at Baseline (screening), Month 3 and Month 6. Change from Baseline was calculated as Qmax score at specified timepoint minus the Baseline Qmax score.|Baseline, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Mililiter/seconds||Standard Deviation|Mean
2649907|NCT01673490|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 6|The IPSS is a screening tool used to assess the symptoms of prostate related disease. The IPSS questionnaire consists of seven symptoms questions including feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 (no symptoms to almost always symptoms) for a total of maximum 35 points. IPSS total is the sum of the scores of seven questions; therefore, the possible total score ranges from 0 to 35 (0-7: Mildly symptomatic; 8-19: Moderately symptomatic; 20-35: Severely symptomatic). IPSS was assessed at Baseline and Month 6. Change from Baseline was calculated as Month 6 IPSS score- minus Baseline IPSS score.|Baseline and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Scores on a scale||Standard Deviation|Mean
2649908|NCT01673490|Primary|Free to Total PSA Ratio at the Indicated Time Points|Serum sample was collected at Screening (Baseline for participants with Free to Total PSA ratio at Month 6), and Month 6 for assessment of free to total PSA ratio. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Free to total PSA ratio at Baseline for participants with free to total PSA Ratio at Month 6 and free to total PSA ratio at month 6 are presented.|Baseline, Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Ratio||Standard Deviation|Mean
2649909|NCT01673490|Primary|Change From Baseline in Total Prostate -Specific Antigen (PSA) at the Indicated Time Points|Serum sample was collected at Baseline, Month 3 and Month 6 for assesment of total PSA. PSA is a substance produced by prostate gland, and the elevated level of PSA indicates prostate cancer or any other non-cancerous condition related to prostate. Change from Baseline in total PSA at Month 3 and Month 6 was calculated as value at specified visist minus Baseline value.|Baseline, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Microgram per liter (ug/L)||Standard Deviation|Mean
2649910|NCT01673490|Primary|Number Participants With a Negative or Positive Response at the Indicated Time Points|Urine samples were collected at Screening (SC), Month 3 (3M) and Month 6 (6M) for urinalysis laboratory assesment. Final value (FV) is defined as the latest post-Baseline value available in the study for each parameter.Urinalysis parameters included erythrocytes, glucose, ketones, leukocytes and protein. Number of participants with a negative (NEG) or positive (POS) response at the indicated time points are summarized.|Screening, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Participants|||Number
2649911|NCT01673490|Primary|Number of Participants With Hematology Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline|Blood samples were collected at Screening, Month 3 (Visit 3) and Month 6 (Visit 5) for hematology laboratory assessments. Hematology parameters included basophils, leukocytes, hemoglobin (HGB), eosinophils, erythrocytes (ery), ery mean Corpuscular HGB concentration, ery mean corpuscular HGB, ery distribution width, lymphocytes, hematocrit, monocytes, neutrophils and platelets. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for hematology parameters are summarized.|Screening, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Participants|||Number
2649912|NCT01673490|Primary|Number of Participants With Clinical Chemistry Values Shift From Normal at Baseline to Abnormal at Any Time Post-Baseline|Blood samples were collected at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5) for chemistry laboratory assessments. Clinical chemistry parameters included alanine aminotrasferase (ALT), aspartate aminotrasferase (AST), creatinine, glucose, potassium, protein, sodium and urea. The number of participants with a shift from normal at Baseline to abnormal at any time post-Baseline for a clinical chemistry parameter are summarized.|Screening, Month 1, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Participants|||Number
2649913|NCT01673490|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings at the Indicated Time Points|A 12 lead ECG was measured at Screening, Month 1 (Visit 1), Month 3 (Visit 3) and Month 6 (Visit 5).|Screening, Month 1, Month 3 and Month 6|ITT Population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.|||Participants|||Number
2649914|NCT01673490|Primary|Number of Participants With Any Post-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.|From start of study medication until follow-up (up to 7 months)|ITT Population|||Participants|||Number
2649932|NCT01673347|Secondary|Range of Motion Plantarflexion|Range of Motion Plantarflexion|3-months postoperative|17 participants available to analyze at 3 months due to early allograft failure in 7 participants|||degrees||Standard Deviation|Mean
2649933|NCT01673347|Secondary|Pain|Pain scored on Visual Analog Scale 0-10; 0 = no pain, 10 = worst pain|3-months postoperative|17 participants available to analyze at 3 months due to early allograft failure in 7 participants|||units on a scale||Standard Deviation|Mean
2649934|NCT01673347|Primary|Allograft Stability|Evaluation of the MTP joint space as determined by radiographic imaging. Count of participants maintaining adequate spacing and alignment as evaluated by the surgeon.|5-years postoperative|Study terminated prior to 5-year endpoint, no participants evaluated||||||
2650669|NCT01667250|Secondary|Mean Change in Headache Days|Mean change in headache days. Change between 4 week run in period to the 8 weeks randomized period.|Run-in period (4 weeks no treatment) and Randomized period (8 weeks)|Data missing for 1 subject in each treatment group|||days||Standard Deviation|Mean
2649915|NCT01673490|Primary|Number of Participants With Any On-treatment Adverse Events (AEs) or Any Serious Adverse Event (SAEs) and Treatment-related AEs|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product at any dose, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, and is associated with liver injury and impaired liver function.|From start of study medication until follow-up (up to 7 months)|Intention-to-Treat (ITT) Population: all enrolled participants regardless of whether or not study treatment was administered.|||Participants|||Number
2649916|NCT01673425|Secondary|Serum Antibody Response to LAIV||Change from baseline in serum antibody response at 6 weeks|||||||
2649917|NCT01673425|Primary|IgA Antibody Titers||Change from baseline in antibody titer at 6 weeks|This study was terminated due to poor enrollment. Analyses were not conducted due to inconclusive nasal wash samples.||||||
2649918|NCT01673373|Secondary|Change in Renal Function|Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 9 months.|Baseline and 9 months|Subset of enrolled subjects with available eGFR measurements.|||eGFR mL/min/1.73 m^2||Standard Deviation|Mean
2649919|NCT01673373|Secondary|Change in Renal Function|Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 30 days.|Baseline and 30 days|Subset of enrolled subjects with available eGFR measurements.|||eGFR mL/min/1.73 m^2||Standard Deviation|Mean
2649920|NCT01673373|Secondary|Change in Number of Anti-Hypertensive Medications|Change in number of anti-hypertensive medications as compared to baseline.|Baseline and 9 months|Subset of enrolled subjects with available medication information.|||Number of Anti-hypertensive Medications||Standard Deviation|Mean
2649921|NCT01673373|Secondary|Secondary Patency Rate|Secondary patency rate at 9 months after a clinically-driven TLR which restores patency after total occlusion.|9 months|All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion.|||Subject-lesions|Subject-lesions||Count of Units
2649922|NCT01673373|Secondary|SBP Control|The change in SBP from baseline to 9 months|Baseline and 9 months|Subset of enrolled subjects with available blood pressure measurements at both time points.|||mmHg||Standard Deviation|Mean
2649923|NCT01673373|Secondary|Systolic Blood Pressure (SBP) Control|The change in SBP from baseline to 30 days|Baseline and 30 days|Subset of enrolled subjects with available blood pressure measurements at both time points.|||mmHg||Standard Deviation|Mean
2649924|NCT01673373|Secondary|Rate of Incidental TLR|The rate of incidental TLR is the rate of TLRs not meeting the definition of a clinically-driven TLR.|9 months|All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion.|||Subject-lesions|Subject-lesions||Count of Units
2649925|NCT01673373|Secondary|Target Lesion Revascularization (TLR)|"Target Lesion Revascularization (TLR) is measured as the proportion of subjects-lesions that require a clinically-driven reintervention of the target lesion through 9 months.~a. A clinically-driven TLR is defined as a TLR (percutaneous balloon angioplasty (PTA), bare metal stent or repeat covered stent deployment, or surgical bypass) due to documented recurrent hypertension from 30-days post-procedure level and/or deterioration in renal function from baseline value, associated with angiographic core laboratory adjudication of a ≥ 60% diameter covered stent restenosis."|9 months|All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion.|||Subject-lesions|Subject-lesions||Count of Units
2649926|NCT01673373|Secondary|Acute Procedural Success|Acute procedural success is defined as technical success without the occurrence of MAE prior to hospital discharge.|Day of Procedure, prior to hospital discharge|All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion with available angiography.|||Subject-lesions|Subject-lesions||Count of Units
2649927|NCT01673373|Secondary|Technical Success|Technical success is defined as successful delivery and deployment of the iCAST™ RX Stent System with ≤ 30% residual angiographic stenosis after covered stent deployment (including post-dilatation) assessed via quantitative vascular analysis (QVA) by an independent core laboratory.|Day of Procedure|All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion with available angiography.|||Subject-lesions|Subject-lesions||Count of Units
2649928|NCT01673373|Secondary|Procedure-Related Major Adverse Events (MAE)|"The occurence of procedure-related MAEs is reported as a percentage of subjects with MAE. Inclusive of:~Procedure- or device-related occurrence of death~Q-Wave myocardial infarction (MI)~Clinically driven target lesion revascularization (TLR)~Significant embolic events defined as unanticipated kidney/bowel infarct, clinically driven by symptoms of abdominal or back pain and confirmed with CT scan or open surgery; lower extremity ulceration or gangrene; or kidney failure."|30 days, 9 months|All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.|||Participants|||Count of Participants
2649929|NCT01673373|Primary|Systolic Blood Pressure|Change in systolic blood pressure (SBP) at 9 months as compared to baseline SBP.|Baseline and 9 months|Subset of enrolled subjects with available blood pressure data at baseline and 9 months.|||mmHg||Standard Deviation|Mean
2649930|NCT01673373|Primary|Primary Patency|Primary patency rate at 9 months was defined as continuous patency without the occurrence of a total occlusion of the original lesion, without a re-intervention to treat a partial or total occlusion of the stented segment, or bypass of the stented segment due to clinically-driven restenosis or occlusion.|9 months|Subset of enrolled subjects with available duplex ultrasound or angiography assessment within the 9-month visit window.|||Subject-lesions|Subject-lesions||Count of Units
2649935|NCT01673282|Primary|The Percent Change in Ratio of Dose and Defined Daily Dose (DDD) for the Drug Load of Concomitant Anti-Epileptic Drugs (AEDs) From Baseline to the End of Observation Period (Day 0 to 6 Months)|Drug load is defined as the sum of the ratios of the actual doses divided by the defined daily dose for all concomitant AEDs.|From Baseline (Day 0) to 6 months|The analysis group for the outcome measure is the Full Analysis Set (FAS). The FAS included all patients who received at least 1 dose of Lacosamide and for whom at least 1 valid ratio of dose and DDD at Baseline and post-Baseline could be calculated.|||percent change of ratio in dose||Standard Deviation|Mean
2649936|NCT01673256|Primary|Assess SJM (St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor) Sensitivity and Positive Predictive Values of AF Episodes of at Least 2 Minutes in Length, Utilizing the Data Collected During the Holter Recording.|"Sensitivity measures the percentage of the actual duration of AF identified by the Holter monitor (for all AF detections that are ≥2 minutes in duration observed in the study) which are correctly identified as AF by the SJM Confirm ICM.~Positive Predictive Value measures the percentage of the duration of AF detected (for all AF detections that are ≥2 minutes in duration observed in the study) by the SJM Confirm that is identified as AF by the Holter monitor."|4 days after Holter starts||||percentage||95% Confidence Interval|Number
2649937|NCT01673191|Primary|Mean Change in Intraocular Pressure||3 months||||millimeters of mercury (mm Hg)||Standard Deviation|Mean
2649938|NCT01673191|Primary|Mean Change in Central Retinal Thickness||3 months||||micrometers||Standard Deviation|Mean
2649939|NCT01673191|Primary|Mean Change in Central Retinal Thickness||2 months||||micrometers||Standard Deviation|Mean
2649940|NCT01673191|Primary|Mean Change in Central Retinal Thickness||1 month||||micrometers||Standard Deviation|Mean
2649941|NCT01673191|Primary|Mean Change in Best Corrected Visual Acuity||3 months||||logMAR units||Standard Deviation|Mean
2649942|NCT01673191|Primary|Mean Change in Best Corrected Visual Acuity||2 months||||logMAR units||Standard Deviation|Mean
2649943|NCT01673191|Primary|Mean Change in Best Corrected Visual Acuity||1 months||||logMAR units||Standard Deviation|Mean
2649944|NCT01673178|Secondary|Apparent Clearance (CL) of PF-05231023|CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||liter/hour (L/hr)||Standard Deviation|Geometric Mean
2649945|NCT01673178|Secondary|Plasma Decay Half-Life (t1/2) of PF-05231023|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-Life was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||hours||Standard Deviation|Mean
2649946|NCT01673178|Secondary|Average Plasma Concentration (Cav ) of PF-05231023 After the Last Dose|Cav was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Geometric Mean
2649947|NCT01673178|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 After Last Dose|Cmin was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Geometric Mean
2649948|NCT01673178|Secondary|Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF-05231023|Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose),0.5(end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24,25,29,39,49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||ratio||Standard Deviation|Geometric Mean
2649949|NCT01673178|Secondary|Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval (Rac) of PF-05231023|Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion ), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24, 25, 29|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||ratio||Standard Deviation|Geometric Mean
2649950|NCT01673178|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Last Dose|Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||ng/mL||Standard Deviation|Geometric Mean
2649951|NCT01673178|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Last Dose|Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||hours||Full Range|Median
2649952|NCT01673178|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Last Dose|AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||ng*hr/mL||Standard Deviation|Geometric Mean
2649953|NCT01673178|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose|Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2649954|NCT01673178|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose|Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8|PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest.|||hours||Full Range|Median
2649955|NCT01673178|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose|AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.|0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hours (pre-dose) on Day 8|Pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2649956|NCT01673178|Primary|Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 49||Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for specified antibodies for each arm, respectively and “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2649957|NCT01673178|Primary|Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 39|Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 39 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.|Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for specified antibodies for each arm, respectively and “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2649958|NCT01673178|Primary|Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 1|Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 1 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.|Day 1|Safety Analysis Set included all participants who receive at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively|||participants|||Number
2649959|NCT01673178|Primary|Change From Baseline in Average Urinary Calcium and Phosphate Levels Over 24 Hours at Day 24||Day 24|Safety analysis set included all participants who received at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively|||mg/24 hours||Standard Deviation|Mean
2649960|NCT01673178|Primary|Average Urinary Calcium and Phosphate Levels Over 24 Hours at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “n” signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively.|||milligram per 24 hours (mg/24hr)||Standard Deviation|Mean
2649961|NCT01673178|Primary|Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 49||Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Deviation|Mean
2649962|NCT01673178|Primary|Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 39||Baseline, Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Deviation|Mean
2649963|NCT01673178|Primary|Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Deviation|Mean
2649964|NCT01673178|Primary|Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units per liter (U/L)||Standard Deviation|Mean
2649965|NCT01673178|Primary|Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 49||Baseline, Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Deviation|Mean
2649966|NCT01673178|Primary|Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 39||Baseline, Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Deviation|Mean
2649967|NCT01673178|Primary|Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Deviation|Mean
2649968|NCT01673178|Primary|Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||microgram per liter (mcg/l)||Standard Deviation|Mean
2649969|NCT01673178|Primary|Percent Change From Baseline Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 49||Baseline, Day 49|Safety analysis set included all participants who receive at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Deviation|Mean
2649970|NCT01673178|Primary|Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 39||Baseline, Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Deviation|Mean
2649971|NCT01673178|Primary|Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percent change||Standard Deviation|Mean
2649972|NCT01673178|Primary|Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||nanogram per milliliter (NG/ML)||Standard Deviation|Mean
2649973|NCT01673178|Primary|Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 49||Baseline, Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||U/L||Full Range|Median
2649974|NCT01673178|Primary|Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||U/L||Full Range|Median
2649975|NCT01673178|Primary|Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 15||Baseline, Day 15|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||U/L||Full Range|Median
2649976|NCT01673178|Primary|Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 8||Baseline, Day 8|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||U/L||Full Range|Median
2649977|NCT01673178|Primary|Creatine Phosphokinase (CPK) Level at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units per liter (U/L)||Full Range|Median
2649978|NCT01673178|Primary|Change From Baseline in Phosphate Level at Day 49||Baseline, Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mg/dL||Full Range|Median
2649979|NCT01673178|Primary|Change From Baseline in Phosphate Level at Day 25||Baseline, Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mg/dL||Full Range|Median
2649980|NCT01673178|Primary|Change From Baseline in Phosphate Level at Day 15||Baseline, Day 15|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mg/dL||Full Range|Median
2649981|NCT01673178|Primary|Change From Baseline in Phosphate Level at Day 8||Baseline, Day 8|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mg/dL||Full Range|Median
2649982|NCT01673178|Primary|Phosphate Level at Baseline||Baseline|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||milligram per deciliter (mg/dL)||Full Range|Median
2649983|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Day 49||Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mcIU/mL||Standard Deviation|Mean
2649984|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Day 39||Day 39|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mcIU/mL||Standard Deviation|Mean
2649985|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Day 25||Day 25|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mcIU/mL||Standard Deviation|Mean
2649986|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Day 1||Day 1|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||mcIU/mL||Standard Deviation|Mean
2649987|NCT01673178|Primary|Thyroid Stimulating Hormone (TSH) Level at Baseline|Results are reported in micro international units per milliliter (mcIU/mL).|Baseline|Safety analysis set included all participants who received at least 1 dose of study medication.|||mcIU/mL||Standard Deviation|Mean
2649988|NCT01673178|Primary|Number of Participants With Abnormal Physical Examinations|Physical examination included general examination and examination of head, ears, eyes, nose, mouth, throat, neck, abdomen, skin, heart, lungs, lymph nodes, and gastrointestinal and musculoskeletal and neurological system.|Baseline up to Day 49|Physical examination data reported in this study was for identification of adverse events and were reported as an adverse event in the adverse event section.||||||
2649989|NCT01673178|Primary|Number of Participants With Clinically Significant Electrocardiogram Findings|Clinically significant ECG findings included PR interval >=300 milliseconds (msec) or >=25 percent (%) increase from baseline (if baseline PR interval >200 msec) or >=50% increase (if baseline PR interval less than or equal to [<=] 200 msec); QRS interval >=140 msec or >=50% increase from baseline; QT interval >=500 msec, corrected QT interval based on Fridericia's formula (QTcF) 450 to <480 msec, 480 to <500 msec, >=500 msec or >=30 msec but <60 msec increase from baseline or >=60 msec increase from baseline.|Baseline up to Day 49|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2649990|NCT01673178|Primary|Number of Participants With Clinically Significant Vital Sign Abnormalities|Criteria for clinically significant vital signs abnormalities included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, supine systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), >=30 mmHg maximum increase and decrease from baseline in same posture, supine diastolic blood pressure (DBP) of <50 mmHg; >=20 mmHg maximum increase and decrease from baseline in same posture.|Baseline up to Day 49|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2649991|NCT01673178|Primary|Number of Participants With Laboratory Abnormalities|Criteria for laboratory test abnormality: Hematology (hemoglobin, hematocrit, red blood corpuscles [RBC] count: less than [<]0.8*lower limit of normal [LLN], platelets: <0.5*LLN/greater than [>]1.75*upper limit of normal [ULN], leukocytes: <0.6*LLN or >1.5*ULN, lymphocytes, total neutrophils: <0.8*LLN or >1.2*ULN, basophils, eosinophil: <0.8*LLN, monocytes: >1.2*ULN); Liver Function (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >0.3*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin: >1.5*ULN; Renal Function (blood urea nitrogen, creatinine: >1.3*ULN, uric acid: >1.2*ULN); Electrolytes (sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN; glucose fasting: <0.6*LLN or >1.5*ULN, urine white blood corpuscles [WBC] and RBC: greater than or equal to (>=) 20/High Power Field [HPF]).|Baseline up to Day 49|Safety analysis set included all participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2649992|NCT01673178|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 28 days after last dose|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2649993|NCT01673126|Secondary|Influence of Time Since Insult on the Results||participants will be followed for the duration of 1 year|||||||
2649994|NCT01673126|Secondary|Influence of Etiology on the Results||participants will be followed for the duration of 1 year|||||||
2649995|NCT01673126|Secondary|Influence of Diagnosis on the Results||participants will be followed for the duration of 1 year|||||||
2650010|NCT01672996|Primary|Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).|Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.|Within 5 minutes after administration for either Ioforminol or Iopamidol.|Evaluted 33 subjects using 80 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray.|||Hounsfield Units||Standard Deviation|Mean
2649996|NCT01673126|Primary|Change in CRS-R Total Scores|"At the group level, assess the modification of CRS-R total scores in anodal tDCS as compared to sham stimulation in VS/UWS and MCS populations~The Coma Recovery Scale Revised (CRS-R) is a behavioral scale performed at the patient's bedside. It consists of 23 hierarchically arranged items that comprise 6 subscales addressing auditory, visual, motor, verbal, communication, and arousal functions.~Scoring is based on the presence or absence of specific behavioral responses to sensory stimuli administered in a standardized manner. Maximum scores of each subscale are summed to obtain the total score (from 0 to 23).~The lowest item on each subscale represents reflexive activity, whereas the highest items represent cognitively mediated behaviors."|Baseline and directly after the tDCS (20 minutes)||||units on a scale||Standard Deviation|Mean
2649997|NCT01673113|Secondary|Mechanical Detection Threshold (MDT)|MDT was evaluated using von Frey Filaments. The up-down method, which evaluates the threshold force for appearance and disappearance of a touch sensation reported by the subject, was used until 3 values were obtained. The values presented in the data table were averaged over all repeats.|48-72 hours post treatment|11 subjects were randomized to have right or left flank treated with cryolipolysis and the untreated flank served as internal control.|||grams|flanks|Inter-Quartile Range|Median
2649998|NCT01673113|Primary|Vibration Detection Threshold (VDT)|"VDT was evaluated using a computerized vibrometer with 1cm2 contact probe placed perpendicularly on the skin (TSA-II, Medoc Inc., Ramat Yishai, Israel). This device gradually increased the vibration magnitude until the subject pressed a stop button to indicate when they first felt the vibration. This test was repeated 8 times. The values presented in the data table were averaged over all repeats."|within 48-72 hours after treatment|11 subjects were randomized to have right or left flank treated with cryolipolysis. The untreated flank served as the internal control.|||(um/sec)|flanks|95% Confidence Interval|Mean
2649999|NCT01673061|Secondary|Unexpected Events|Any unexpected events that would occur during study period, including adverse events, on Day 1.|Measured continuosly from consent to discharge, on Day 1.|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2650000|NCT01673061|Secondary|Willingness to Use Method of Anesthesia in the Future|Willingness of the subject to use their assigned method of anesthesia again if they were to require the same procedure in the future. Measured once on Day 1.|Once, on Day 1|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2650001|NCT01673061|Secondary|Change in VNRS - From Pre-anesthesia to Post-procedure|Difference between the VNRS pain scale values collected just prior to anesthesia administration, and at after all aspects of incision and drainage are complete, on Day 1.|Once, on Day 1|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2650002|NCT01673061|Secondary|Change in VNRS - From Pre-anesthesia to Administration of Anesthesia|Difference between the VNRS pain scale values collected just prior to anesthesia administration, and at the moment of anesthesia administration, on Day 1.|Once, on Day 1|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2650003|NCT01673061|Secondary|VNRS Pain Scale - Incision and Drainage|Visual Numeric Rating Scale (VNRS) for pain level during incision and drainage of the abscess on Day 1.|Once, on Day 1, at time of incision and drainage|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2650004|NCT01673061|Primary|VNRS Pain Scale - Anesthetic Administration|Visual Numeric Rating Scale (VNRS) for pain level at time of anesthetic administration on Day 1.|Once, on Day 1, at time of anesthetic administration|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2650005|NCT01673022|Primary|Estimate the Sensitivity of the Sentinel Lymph Node|To estimate the sensitivity of the sentinel lymph node in the determination of lymph node metastases in patients with invasive carcinoma of the cervix and uterus using Indocyanine Green (ICG) and robotic assisted near infrared (NIR) imaging. Sensitivity is defined as the proportion of sentinel lymph node: number of participants with, determined to be metastatic by both IGR/NIR and pathology out of the sentinel lymph nodes found to be metastatic by pathology.|3 years|Sensitivity of the sentinel lymph node|||Participants|||Count of Participants
2650006|NCT01673009|Secondary|Serum Bioactivity|The investigators will quantitate the biologic activity of patient serum on fibroblast proliferation, migration, and collagen synthesis pre and post-Gleevec (7 days and 1 month)|7 days and 1 month|unable to measure this outcome because assay became unavailable||||||
2650007|NCT01673009|Primary|Percent Change From Baseline in Tumor Volume at 6 Months|Volumetric measures were performed using MRI scan analysis. Response criteria include greater than 20 percent decrease in tumor volume as responsive. Greater than 20 percent increase in tumor volume as tumor progression. Less then 20 percent increase or decrease in tumor volume is stable disease|baseline to 6 months||||percentage change of tumor volume||95% Confidence Interval|Median
2650008|NCT01672996|Primary|Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg).|Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.|Within 5 minutes after administration for either Ioforminol or Iopamidol.|Evaluted 33 subjects using 100 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray. tube.|||Hounsfield Units||Standard Deviation|Mean
2650009|NCT01672996|Secondary|Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).|Recording the occurrence of treatment emergent adverse events (TEAE).|Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration.|These are the numbers of Treatment Emergent Adverse Events (TEAE) and TEAEs related to Investigational Medicinal Product (IMP).|||Adverse Events|||Number
2650011|NCT01672983|Secondary|Percentage of Participants With End of Treatment (EOT) Response|The percentage of participants with EOT response (plasma HCV RNA level < LLOQ at week 12 for the 12-week duration arms and Week 24 for the 24-week duration arms12). The LLOQ for the assay was 25 IU/mL.|12 or 24 weeks after first dose of study drug|ITT population|||percentage of participants||95% Confidence Interval|Number
2650012|NCT01672983|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12)|The percentage of participants with SVR12 (plasma HCV RNA level < LLOQ 12 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.|12 weeks after last dose of study drug|ITT population|||percentage of participants||95% Confidence Interval|Number
2650013|NCT01672983|Primary|Number of Participants With Adverse Events (AEs)|An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to study drug were assessed as being either probably or possibly related by the investigator. Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug administration to 30 days after last dose; SAEs were collected from the time that informed consent was obtained to 30 days after last dose.|TEAEs: up to 16 weeks for the 12-week treatment groups and up to 28 weeks for the 24-week treatment groups; SAEs: up to 65 weeks for the 12-week treatment groups and up to 77 weeks for the 24-week treatment groups.|Safety population: all participants who received at least 1 dose of study drug|||participants|||Number
2650014|NCT01672983|Primary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)|The percentage of participants with SVR24 (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ] 24 weeks after the last dose of study drug). The LLOQ for the assay was 25 IU/mL.|24 weeks after last dose of study drug|Intent-to-treat (ITT) population: all subjects who received at least 1 dose of study drug|||percentage of participants||95% Confidence Interval|Number
2650015|NCT01672970|Secondary|Change From Baseline in Particpant's Assessment of RA Morning Stiffness Assessed Using VAS at Months 3 and 6|Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||units on a scale||Standard Deviation|Mean
2650016|NCT01672970|Secondary|Change From Baseline in Participant's Assessment of RA-Related Pain Using VAS at Months 3 and 6|Severity of pain was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the severity of pain that they had experienced because of their RA, ranging from 0 (no pain) to 100 (unbearable pain).|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||units on a scale||Standard Deviation|Mean
2650017|NCT01672970|Secondary|Change From Baseline in Participant's Assessment of Fatigue Using VAS at Months 3 and 6|Fatigue was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the level of fatigue that they have experienced, ranging from 0 (no fatigue) to 100 (extreme fatigue).|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||units on a scale||Standard Deviation|Mean
2650018|NCT01672970|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Months 3 and 6|The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||units on a scale||Standard Deviation|Mean
2650019|NCT01672970|Secondary|Change From Baseline in Participant Global Assessment of Disease Activity at Months 3 and 6|"The Participant's Global Assessment of Disease Activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||units on a scale||Standard Deviation|Mean
2650020|NCT01672970|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6|"The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||units on a scale||Standard Deviation|Mean
2650021|NCT01672970|Secondary|Percentage of Participants Who Achieved 90% Improvement in ACR (ACR90) Response|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR90 response required at least a 90% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|Baseline, 3 and 6 months|FAS population|||percentage of participants||95% Confidence Interval|Number
2650022|NCT01672970|Secondary|Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR70 response required at least a 70% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|Baseline, 3 and 6 months|FAS population|||percentage of participants||95% Confidence Interval|Number
2650023|NCT01672970|Secondary|Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR50 response required at least a 50% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|Baseline, 3 and 6 months|FAS population|||percentage of participants||95% Confidence Interval|Number
2650024|NCT01672970|Secondary|Percentage of Participants Who Achieved 20 Percent (%) Improvement in ACR (ACR20) Response|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement.|Baseline, 3 and 6 months|FAS population|||percentage of participants||95% Confidence Interval|Number
2650025|NCT01672970|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Months 3 and 6|The CDAI was a combined index for measuring disease activity in RA and used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. It was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH (assessed on 0-100 mm VAS); VAS (0 = no disease activity and 100 = worst disease activity). CDAI total score = 0-76. A CDAI score of <=2.8 represented clinical remission, a score of >2.8 to <=10.0 represented low disease activity, a score of >10.0 to <=22.0 represented moderate disease activity and a score of >22.0 represented high (or severe) disease.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||units on a scale||Standard Deviation|Mean
2650026|NCT01672970|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Months 3 and 6|The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician's global assessment (PhGH) of disease activity, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP) (milligrams per deciliter [mg/dL]). SDAI total score = 0-86. A SDAI score of <=3.3 represented clinical remission, a score of >3.4 to <=11.0 represented low disease activity, a score of >11 to <=26.0 represented moderate disease activity and a score of >26.0 represented high (or severe) disease.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||units on a scale||Standard Deviation|Mean
2650027|NCT01672970|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response|Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH (mm), and ESR (mm/hr). DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (>=) -0.6, DAS28 >3.2 to <=5.1 or CFB >=-0.6 and DAS28 >5.1 or CFB >=-0.6.|Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Months 6) and Visit 8 (Final Visit; within 2 weeks after 6months observation period)|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2650028|NCT01672970|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Months 3 and 6|DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and Participant's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, higher score=more disease activity. DAS28 <3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||units on a scale||Standard Deviation|Mean
2650670|NCT01667250|Primary|Safety - Number of Participants With Adverse Events|Safety was assessed by collecting Adverse Effects|Up to 8 weeks - duration of the Randomized period|Randomized population|||Participants|||Count of Participants
2650029|NCT01672970|Secondary|Change From Baseline in Swollen Joint Count (66 Joints) at Months 3 and 6|The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 66 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||joint count||Standard Deviation|Mean
2650030|NCT01672970|Secondary|Change From Baseline in Swollen Joint Count (28 Joints) at Months 3 and 6|The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 28 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||joint count||Standard Deviation|Mean
2650031|NCT01672970|Secondary|Change From Baseline in Tender Joint Count (68 Joints) at Months 3 and 6|The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 68 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||joint count||Standard Deviation|Mean
2650032|NCT01672970|Secondary|Change From Baseline in Tender Joint Count (28 Joints) at Months 3 and 6|The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 28 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28.|Baseline, 3 and 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure. Here “n”= participants who were evaluable for each category.|||joint count||Standard Deviation|Mean
2650033|NCT01672970|Secondary|Percentage of Participants With Reason for DMARD Withdrawal|Objective intolerance was determined by medical observation; subjective intolerance was determined by the participant; lack of efficacy was determined by physician discretion.|6 months|FAS population. Here number of participants analyzed = participants available for the analysis of this outcome measure.|||percentage of participants|||Number
2650034|NCT01672970|Secondary|Percentage of Participants on Tocilizumab Monotherapy|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population|||percentage of participants||95% Confidence Interval|Number
2650035|NCT01672970|Secondary|Percentage of Participants Adhered to the Dosing Regimen Recommended by Physician for TCZ|A participant's adherence was calculated based on the adverse event or laboratory abnormality experienced by the participants who required dose modifications as per local TCZ label or protocol.|6 months|FAS population|||percentage of participants|||Number
2650036|NCT01672970|Secondary|Number of Participants With Restoration of Initial Dosing Regimen of TCZ|The number of participants who reported restoration of initial dosing regimen of TCZ for 84.00, 133.00, 158.00, 2.3.00 and 206.00 days, were reported.|6 months|Per protocol population|||participants|||Number
2650037|NCT01672970|Secondary|Percentage of Participants Discontinued From Tocilizumab for Safety And Efficacy Reasons|The safety variable measured the number of participants who discontinued TCZ due to adverse reactions to TCZ, and the efficacy variable measured the participants who discontinued from TCZ due to lack of efficacy according to criteria of the treating physician.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2650038|NCT01672970|Secondary|Mean Dosing Interval of Treatment at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here number of participants analyzed = participants available for the analysis of this outcome measure.|||days||Standard Deviation|Mean
2650039|NCT01672970|Secondary|Mean Dose of TCZ at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here number of participants analyzed = participants available for the analysis of this outcome measure.|||milligrams per kilogram {mg/kg)||Standard Deviation|Mean
2650040|NCT01672970|Secondary|Number of Participants With Reasons for Dose Modification for TCZ|Only those participants that had dose modifications were reported.|6 months|FAS population|||participants|||Number
2650041|NCT01672970|Secondary|Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments|Lack of efficacy was determined as per physicians' discretion. Intolerance was defined as the participant could not be treated due to safety reason (adverse events).|Baseline|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2650042|NCT01672970|Secondary|Percentage of Participants With Duration of Previous Biologic RA Treatments|The duration of previous biologic RA treatments was classified in to two categories: less than (<) 6 months and greater than (>) 6 months.|Baseline|Per protocol population included all participants who had a valid tocilizumab administration assessment at 6-month time window and without any protocol violations.|||percentage of participants|||Number
2650043|NCT01672970|Secondary|Number of Previous Biologic RA Treatments Received by Participants||Baseline|FAS population|||biologic treatments|||Number
2650044|NCT01672970|Secondary|Percentage of Participants With Reason for DMARDs Withdrawal at Baseline|DMARDs exposure was evaluated for all participants. DMARDs treatment at baseline included participants, who were receiving DMARDs when they were included in the study and discontinued at baseline and not used as concomitant medication to TCZ.|Baseline|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2650118|NCT01671748|Primary|Actual Change in Wound Area|Wound area is measured weekly using a digital wound imaging device. The wound boundary is digitally traced by a blinded assessor. Percentage and actual change in wound area between start of treatment (week 5) and end of treatment (week 13) is evaluated.|Week 5 to 13|As previous|||cm2||Standard Deviation|Mean
2650045|NCT01672970|Secondary|Percentage of Participants Who Stopped DMARDs Prior to Start of Study and at Baseline|"DMARDs exposure was evaluated for all participants. Prior DMARDs treatment included participants, who were treated with DMARDs 8 weeks according to physician's discretion before being included in the study. DMARDs treatment at baseline included participants who were receiving DMARDs when they were included in the study and continued with this concomitant medication in addition to TCZ."|Prior to study (8 weeks) to Baseline|FAS population|||percentage of participants||95% Confidence Interval|Number
2650046|NCT01672970|Secondary|Percentage of Participants With Systemic Manifestations of RA at Baseline|Systemic manifestations of RA at baseline included anemia, fatigue, conventional risk factor(s) for cardiovascular disease, C-reactive protein (CRP) above upper limit of normal rheumatoid nodules, rheumatoid vasculitis, and interstitial lung disease.|Baseline|FAS population|||percentage of participants||95% Confidence Interval|Number
2650047|NCT01672970|Primary|Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation||6 months|FAS population|||percentage of participants||95% Confidence Interval|Number
2650048|NCT01672957|Secondary|Percentage of Participants With Graft Survival|Graft survival was defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), re-transplant or death during the first 12 months after transplantation.|Months 1, 6, and 12|Safety population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.|||percentage of participants|||Number
2650049|NCT01672957|Secondary|Percentage of Participants With Acute Rejection|Percentage of participants who experienced acute rejection within 1 month of transplantation, Month 2 to Month 6 after transplantation, Month 7 to Month 12 after transplantation are reported.|Baseline to Month 1, Months 2 to 6, Months 7 to 12|Safety population included all enrolled renal transplant participants who received mycophenolate mofetil containing immunosuppressive combination therapy (safety population=128). Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.|||percentage of participants|||Number
2650050|NCT01672957|Secondary|Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil|Participants could have received more than one other immunosuppressive agents, at the discretion of treating physician. Percentage of participants who received 1 other immunosuppressive agent, 2 other immunosuppressive agents, and 3 other immunosuppressive agents are reported.|Baseline, Months 1, 6, and 12|ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.|||percentage of participants|||Number
2650051|NCT01672957|Secondary|Mean Dose of Mycophenolate Mofetil||Baseline, Months 1, 6, and 12|ITT population. Number of participants analyzed = participants evaluable for this outcome measure. Here 'n' signifies number of participants evaluable at specified time-points.|||milligrams (mg)||Standard Deviation|Mean
2650052|NCT01672957|Primary|GFR at Month 12 After Transplantation|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR < 15 mL/min indicates kidney failure.|Month 12|ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.|||mL/min||Standard Deviation|Mean
2650053|NCT01672957|Primary|GFR at Month 6 After Transplantation|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR < 15 mL/min indicates kidney failure.|Month 6|ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.|||mL/min||Standard Deviation|Mean
2650054|NCT01672957|Primary|Glomerular Filtration Rate (GFR) at Month 1 After Transplantation|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is greater than (>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR less than (<) 15 mL/min indicates kidney failure.|Month 1|ITT population. Number of participants analyzed = participants evaluable for GFR at specified time-point.|||mL/min||Standard Deviation|Mean
2650055|NCT01672957|Primary|Creatinine Clearance at Month 12 After Transplantation|Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Month 12|ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.|||mL/min||Standard Deviation|Mean
2650056|NCT01672957|Primary|Creatinine Clearance at Month 6 After Transplantation|Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Month 6|ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.|||mL/min||Standard Deviation|Mean
2650057|NCT01672957|Primary|Creatinine Clearance at 1 Month After Transplantation|Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Month 1|ITT population. Number of participants analyzed = participants evaluable for creatinine clearance at specified time-point.|||mL/min||Standard Deviation|Mean
2650119|NCT01671748|Secondary|Number of Non-serious Adverse Events in Each Group|Adverse events (AEs) were defined as any undesirable clinical occurrence in a subject whether it is thought to be related to the investigational device or not.|Week 5 to 13||||Number of non-serious AEs|||Number
2650671|NCT01667224|Secondary|Changes in Body Mss Index(BMI)|BMI was measured in study visit 1 (0 week), visit 2 (4 week), visit 3 (8 week) and visit 4 (12 week).|study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)||||kg/m^2||Standard Error|Mean
2650058|NCT01672892|Secondary|Mean Change From Baseline in EPIC Bowel and Urinary Domain (Validation - Sensitivity to Treatment)|"The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. Difference is calculated as baseline - week 5.~A positive change score represents a decline in function."|Baseline and week 5 of RT|Questionnaires were not completed by all eligible participants. Therefore, for both domains only 234/279 (arms combined) participants had data at both baseline and week 5. [later analysis]|||score on a scale||Standard Deviation|Mean
2650059|NCT01672892|Secondary|Pearson Correlation Coefficient for EPIC Bowel and Urinary Domains vs. FACT-G Total Score (Validation - Criterion Validity)|The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. The FACT-G is 27-item measure. Higher scores represent higher QOL. Each item has 5 responses options, 0=Not a lot and 4=Very much. Items are added together for the total score, ranging from 0-108. Certain items must be reversed before adding by subtracting the response from 4. The Pearson correlation coefficient is a measure of the linear correlation between two variables with a value between +1 and −1, where 1 is total positive linear correlation, 0 is no linear correlation, and −1 is total negative linear correlation.|Baseline and week 5 of RT|Participants with baseline EPIC and FACT-G scores [later analysis] Questionnaires were not completed by all eligible participants. Therefore, for both domains only 231/279 (arms combined) participants had both FACT-G and EPIC data at baseline, and 199/279 participants had both FACT-G and EPIC data at week 5. [later analysis]|||correlation coefficient|||Number
2650060|NCT01672892|Secondary|Spearman's Correlation Coefficient for EPIC Bowel Domain vs. Urinary Domains (Validation - Conceptual Independence)|The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Spearman's rank correlation coefficient is a nonparametric measure of rank correlation between two variables with a value between +1 and −1, where 1 is total positive rank correlation, 0 is no rank correlation, and −1 is total negative rank correlation.|Baseline and week 5 of RT|Questionnaires were not completed by all eligible participants. Therefore, for both domains data was only collected from: 277/279 (arms combined) at baseline, 241/279 at week 5. [later analysis]|||correlation coefficient|||Number
2650061|NCT01672892|Secondary|Standardized Cronbach's Alpha for EPIC Bowel and Urinary Domains (Validation - Internal Consistency Reliability)|The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Cronbach's alpha is an internal consistency estimate of reliability of psychometric test scores and is a function of the number of items in a test, the average covariance between item-pairs, and the variance of the total score. An alpha of 0.60-0.79 was to be considered acceptable reliability; higher than 0.8 was to be considered good reliability.|Baseline and week 5 of RT|Questionnaires were not completed by all eligible participants. Therefore, for both domains data was only collected from: 277/279 (arms combined) at baseline, 241/279 at week 5. [later analysis]|||standard deviation|||Number
2650062|NCT01672892|Secondary|Identification of Molecular Predictors of Radiation Toxicity and Novel Circulating Cancer Biomarkers||Outcome measure will not be analyzed|The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.||||||
2650063|NCT01672892|Secondary|Overall Survival|Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.|From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.|Eligible participants [later analysis]|||percentage of participants||95% Confidence Interval|Number
2650064|NCT01672892|Secondary|Disease-free Survival|Disease (progression) is defined as local recurrence, para-aortic recurrence, or distant metastasis. Local recurrence is defined as a disease in the radiation treatment field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Distant metastasis is defined as involvement of another organ or peritoneal disease. Disease-free survival time is defined as time from randomization to the date of progression, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.|From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.|Eligible participants [later analysis]|||percentage of participants||95% Confidence Interval|Number
2650120|NCT01671748|Secondary|Incidence of Wound Infection|Median number of wound infections per patient (as demonstrated by clinical symptoms) from beginning of treatment (week 5) and end of treatment (week 13).|Weeks 5 to 13|All patients included; ITT.|||Number of infections per patient||Inter-Quartile Range|Median
2650672|NCT01667224|Secondary|Changes in Body Weight.|Body weight was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).|study visit 1(0 week), visit 2(4 week), visit 3(8 week), and visit 4(12 week)||||kg||Standard Error|Mean
2650065|NCT01672892|Secondary|Local-regional Recurrence|Local recurrence is defined as a disease in the radiation treatment field. This can include a local vaginal recurrence or nodal disease within the field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Local-regional control time is defined as time from randomization to the date of local recurrence, last known follow-up (censored), or death (competing risk). Local-regional recurrence rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.|From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months.|Eligible participants [later analysis]|||percentage of participants||95% Confidence Interval|Number
2650066|NCT01672892|Secondary|Health Utilities, as Measured by Change From Baseline in EQ-5D|The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state). Change from baseline is calculated as score at the timepoint of interested - baseline score.|Baseline, week 5 of RT, 4-6 weeks after RT|Questionnaires were not completed by all eligible participants. Therefore, data was only collected from: Intensity-Modulated Radiation Therapy arm: 78/130 at baseline and week 5, 74/130 at baseline and 4-6 weeks post-RT; Standard Radiation Therapy arm: 91/149 at baseline and week 5, 89/149 at baseline and 4-6 weeks post-RT.|||score on a scale||Standard Deviation|Mean
2650067|NCT01672892|Secondary|Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale|The FACT-G is a validated, 27-item measure where a higher score represents higher QOL. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, with 0=Not a lot and 4=Very much. All items in a subscale are added together to obtain subscale totals. Scores range from 0-108 for the FACT-G total score, 0-28 for physical, social, functional, and 0-24 for emotional subscale. Certain items must be reversed before it is added by subtracting the response from 4. Subscale totals are summed to form the FACT-G total score. The FACT-Cx is 5-items, with score ranging 0-60, but is not included in total FACT-G. Each subscale requires >= 50% of items completed and overall response rate must be greater than 80%. If items are missing, the subscale scores can be prorated. Change calculated as follow-up score - baseline score so that a negative change score indicates a decline in function.|Before study start, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT|Questionnaires were not completed by all eligible participants. Therefore, the number of participants reported below are the number with the relevant questions answered at baseline and the given time point on each arm.|||score on a scale||Standard Deviation|Mean
2650068|NCT01672892|Secondary|Urinary Toxicity, as Measured by Change in EPIC Urinary Domain|The primary endpoint is change in acute GI toxicity, as measured by the EPIC urinary domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC urinary domain consists of 12 items and has a function subscale (5 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function.|Baseline, week 3 and 5 of RT, and 4-6 weeks after RT|Questionnaires were not completed by all eligible participants. Therefore, data was only collected from: Arm A- 110/130 at baseline and week 3, 107/130 at baseline and week 5, 99/130 at baseline and 4-6 weeks; Arm B- 127/149 at baseline and week 3, 126/149 at baseline and week 5, 121/149 at baseline and 4-6 week.|||score on a scale||Standard Deviation|Mean
2650069|NCT01672892|Secondary|Percentage of Patients With Acute Grade 2+ GI Toxicity at 5 Weeks From the Start of Treatment|Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.|Baseline to Week 5 of RT|Adverse event data was not obtained from all eligible participants at 5 weeks from treatment start. Therefore, only 122/130 had data on the Intensity-Modulated Radiation Therapy arm, and only 136/149 had data at on the Standard Radiation Therapy arm.|||percentage of participants||95% Confidence Interval|Number
2650070|NCT01672892|Primary|Acute Gastrointestinal Toxicity, as Measured by Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score at 5 Weeks From the Start of Pelvic Radiation|The primary endpoint is change in acute GI toxicity, as measured by the EPIC bowel domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function.|Baseline and week 5 of RT|Questionnaires were not completed by all eligible participants. Therefore, only 107/130 had data at both baseline and week 5 on the Intensity-Modulated Radiation Therapy arm, and only 126/149 had data at both baseline and week 5 on the Standard Radiation Therapy arm.|||units on a scale||Standard Deviation|Mean
2650424|NCT01668836|Primary|Direct Evaluation of the Sirtuin 1 Gene Expression|"The Sirtuin 1 gene expression was measured by real time PCR in peripheric blood. Unit of measure was arbitrary unit. Arbitrary unit was relative to the control gene expression (control gene = 1)."|30 days post-treatment||||arbitrary unit relative to control gene||Standard Deviation|Mean
2650071|NCT01672879|Primary|Event-Free Survival (EFS) Using Kaplan-Meier|"Event free survival (EFS) was the primary clinical efficacy endpoint and was assessed by time to first liver-related event or death, whichever occurs first. Liver-related events included any of the following:~Liver transplantation~Qualification for liver transplantation~Model for End-Stage Liver Disease (MELD) ≥ 15~Events indicative of hepatic decompensation~Esophageal variceal bleeding~Ascites~Hepatic Encephalopathy~≥ 2 point increase in Child Pugh-Turcotte (CPT) score~Newly diagnosed varices in a subject without prior varices"|Baseline up to the time of clinical event or last dose date (maximum: 240 weeks in Blinded Phase); which ever occurred first|Participants in the Full Analysis Set were analyzed.|||months||95% Confidence Interval|Median
2650072|NCT01672879|Primary|Change From Baseline in Hepatic Venous Pressure Gradient (HVPG)||Baseline to Week 96|Participants in the Full Analysis Set with available data were analyzed.|||mmHg||Standard Deviation|Mean
2650073|NCT01672866|Primary|Event Free Survival (EFS) Using Kaplan-Meier|The EFS was the primary clinical efficacy endpoint and was assessed by the time to progression to cirrhosis. Participants were considered to have become cirrhotic if they had a post-baseline biopsy consistent with cirrhosis or developed overt signs and symptoms of cirrhosis. All overt signs and symptoms went through an adjudication process and were confirmed before they were considered for the EFS analysis.|Baseline up to the time of progression to cirrhosis or last dose date (maximum: 240 weeks in the Blinded Phase), which ever occurred first|Participants in the Full Analysis Set were analyzed.|||months||95% Confidence Interval|Median
2650074|NCT01672866|Primary|Change From Baseline in MQC on Liver Biopsy||Baseline to Week 96|Participants in the Full Analysis Set (all enrolled participants who were randomized and received at least 1 dose of study drug) with available data were analyzed.|||percentage of liver collagen||Standard Deviation|Mean
2650075|NCT01672853|Secondary|Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality|A treatment-emergent graded laboratory abnormality was defined as an increase of at least 1 abnormality grade from the predose assessment and occurring after the predose visit and on or before the date of the administration of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant [Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (life-threatening)].|First dose date up to Week 96 plus 30 days|Participants in the Safety Analysis Set with at least one post-baseline measurement were analyzed.|||percentage of participants|||Number
2650076|NCT01672853|Secondary|Study Drug Exposure|The average SIM exposure was summarized.|First dose date up to Week 96|Participants in the Safety Analysis Set were analyzed.|||weeks||Standard Deviation|Mean
2650077|NCT01672853|Secondary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||First dose date up to Week 96|The Safety Analysis Set included participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2650078|NCT01672853|Primary|Change From Baseline in MQC on Liver Biopsy at Week 96||Baseline; Week 96|Participants in the Full Analysis Set (participants who were randomized into the study and received at least 1 dose of study drug) with available data were analyzed.|||percentage of MQC||Standard Deviation|Mean
2650079|NCT01672827|Primary|Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images.|Statistical analysis of summary of sensitivity of blinded visual PET image interpretations without anatomic images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study.These Readers examined the PET images for evidence of amyloid plaque.|Post flutemetamol administration|Number of Blinded visual PET Image Interpretations from Readers 1-5. These Readers provided their interpretations without Anatomic Images who had normal Standard of Truth (SoT).|||Percentage (True Negative)||95% Confidence Interval|Number
2650080|NCT01672827|Secondary|Inter-Reader Agreement of PET Images Without Anatomic Images|Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images. This data consists of image interpretations by investigators and No subjects were dosed in this study.|Post Flutemetamol Injection||||Number of inter-reader agreements|||Number
2650081|NCT01672827|Primary|Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images.|Statistical analysis of summary of the blinded visual PET Image Interpretations without Anatomic Images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study. These Readers examined the PET images for evidence of amyloid plaque.|Post flutemetamol administration|Number of Blinded visual PET Image Interpretations from Readers 1-5. These Readers provided their interpretations without Anatomic Images who had abnormal Standard of Truth (SoT).|||Percentage (True Positive)||95% Confidence Interval|Number
2650082|NCT01672788|Secondary|Metformin: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point.~In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2650083|NCT01672788|Primary|Metformin: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the analyte in plasma, per period.~In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2650121|NCT01671748|Secondary|Change in Ulcer Pain Between Week 5 (Randomisation) and Week 13 (Exit)|Pain was scored by each patient on a visual analogue score (VAS) from 0 to 100. A VAS score of 0 indicated no pain whilst a VAS score of 100 indicated worst possible pain. Change in pain scores were calculated by subtracting week 5 values from week 13 values.|Weeks 5 to 13||||scores on a scale||Standard Deviation|Mean
2650084|NCT01672788|Primary|Empa: Maximum Measured Concentration (Cmax)|"Maximum measured concentration of the analyte in plasma, per period.~In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2650085|NCT01672788|Secondary|Empa: Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point.~In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2650086|NCT01672788|Primary|Metformin: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2650087|NCT01672788|Primary|Empa: Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.~In this endpoint, the Measured values shows inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|Pharmacokinetic (PK) set: All subjects who took at least 1 dose of investigational treatment, provided at least 1 observation for at least 1 primary PK endpoint, did not have important protocol violations relevant to the evaluation of relative bioavailability, did not vomit at or before 2 times median tmax and did not use restricted medications|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2650088|NCT01672736|Primary|Maximum Tolerated Dose of the Combination of ASP7487 (OSI-906) With Velcade and Dexamethasone|"Phase 1: To determine the maximum tolerated dose (MTD) of ASP7487 (OSI-906) administered in combination with the recommended dose and schedule of bortezomib and dexamethasone;~Phase 2: To evaluate the antitumor activity of ASP7487 (OSI-906) in combination with bortezomib and dexamethasone at the MTD established from the Phase 1 component."|45 months||||milligrams|||Number
2650089|NCT01672723|Other Pre-specified|Self-reported Physical Symptoms|"At the end of each day while on a study drug (4 days when on naltrexone and 4 days when on placebo) participants reported on their physical symptoms (headaches, dizziness/faintness, nausea, appetite increase/decrease) on a 0 (no symptoms) to 4 (very severe) scale.~Responses were averaged across study drug to evaluate a single outcome for days when participants were on naltrexone and a single outcome for days when participants were on placebo."|once a day for 8 days||||units on a scale||Standard Deviation|Mean
2650090|NCT01672723|Secondary|Daily Self-reported Feelings of Social Connection|"For 8 days (4 while on placebo, 4 while on naltrexone), participants were asked to think back to the last 24 hours and respond to how disconnected they felt (I felt out of touch and disconnected from others). Ratings were made on a 1-7 scale anchored by 'strongly disagree' and 'strongly agree.' For ease of interpretation, feelings of disconnection were reverse-coded to measure daily feelings of social connection. Thus higher numbers indicate greater feelings of connection. Responses were averaged across the 4 days that participants were on each study drug (4 while on placebo, 4 while on naltrexone)."|end of day for 8 days||||units on a scale||Standard Error|Mean
2650091|NCT01672723|Primary|Changes in Self-reported Feelings of Connection During Naltrexone (vs. Placebo)|"Participants will read positive, loving messages from friends and family members and then rate their feelings of connection (how connected, touched, and warm they felt, α = .93, averaged to create a measure of feelings of social connection). Ratings were made on a 1-7 scale anchored by not at all and very. Higher numbers indicate greater feelings of connection in response to reading the loving messages."|participants will report on their feelings of connection during two separate lab visits, on day 4 of each drug assignment||||units on a scale||Standard Error|Mean
2650092|NCT01672710|Secondary|Fatigue Severity|Multidimensional fatigue inventory. change in Self reported fatigue severity. Measures 5 dimensions of fatigue: general, physical, mental, reduced motivation and reduced activity. Scores 4-20 in each dimension, higher score worse fatigue.|baseline, 5 weeks||||score on a scale||Standard Deviation|Mean
2650093|NCT01672710|Primary|Short Form-36 for Veterans Quality of Life Physical Component Summary Scores|"Qualify of life will be determined per Short Form-36 for veterans quality of life Physical component (PCS) summary scales, range from 0 to 100 with 100 being better; 50 is expected population average.~immediate intervention and waitlist groups changes compared from baseline and adjusted mean differences at end of 5 weeks."|baseline, 5 weeks||||score on a scale||Standard Deviation|Mean
2650156|NCT01671085|Secondary|PK: Time of Maximum Concentration (Tmax) of LY3015014|tmax was calculated after each dosing of LY3015014 and is reported as the number of days for observed maximum concentration of LY3015014.|Day 1 and 29: 4 h and 24 h postdose|FAS: Data from all randomized participants who received at least 1 dose of study drug according to the treatment the participants actually received and had evaluable PK data for tmax.|||days||Full Range|Median
2650094|NCT01672658|Secondary|Dizziness Handicap Inventory|"A 25-item self-assessment inventory designed to evaluate the self-perceived handicapping effects imposed by dizziness. Participants complete the questionnaire only if they report dizziness.~Self-report questionnaire Quantifies the impact of dizziness on daily life by measuring self-perceived handicap Three domains: functional (9 questions, 36 points), emotional (9 questions, 36 points), and physical (7 questions, 28 points) Maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) to Minimum score of 0. The higher the score, the greater the perceived handicap due to dizziness Item scores are summed Answers are graded 0 (no), 2 (sometimes) and 4 (yes)"|Pre-training, mid training, post training|This data includes the participants in this study that self reported yes to dizziness. If they answered no to dizziness they did not have the scale administered to them.|||Units on a scale||Standard Deviation|Mean
2650095|NCT01672658|Secondary|Activities Balance Confidence Scale (ABC)|"Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness.~16-item self-report measure in which patients rate their balance confidence for performing activities. This stem is used to lead into each activity considered: How confident are you that you will not lose your balance or become unsteady when you... Items are rated on a rating scale that ranges from 0 - 100 Score of zero represents no confidence, a score of 100 represents complete confidence Overall score is calculated by adding item scores and then dividing by the total number of items"|Pre-training, mid training, post training||||units on a scale||Standard Deviation|Mean
2650096|NCT01672658|Secondary|Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Open|"The mCTSIB provides the clinician with a means to quantify postural control under various sensory conditions.~The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.~The scores of the 3 trials are averages"|Pre-training, mid training (4 weeks), post training (8 weeks)||||sec||Standard Deviation|Mean
2650097|NCT01672658|Secondary|Modified Clinical Test of Sensory Organization and Balance (mCTSlB) - Eyes Closed|"Clinical Test of Sensory Interaction and Balance (CTSIB): assesses balance under a variety of conditions including vision blocked and surface challenges.~The patient performance is timed for 30 seconds. Test is terminated when a subject's arms or feet change position. If a patient in unable to maintain the position for 30 seconds they are provided with 2 additional attempts.~The scores of the 3 trials are averages"|Pre-training, mid training, post training||||sec||Standard Deviation|Mean
2650098|NCT01672658|Secondary|Six Minute Walk Test|Assesses distance walked over 6 minutes|Pre-training, mid training (4 weeks), post training (8 weeks)||||Feet||Standard Deviation|Mean
2650099|NCT01672658|Secondary|10 Meter Walk Test|assesses walking speed of short duration|Pre-training, mid training (4 weeks), post training (8 weeks)||||m/s||Standard Deviation|Mean
2650100|NCT01672658|Primary|Functional Gait Assessment (FGA)|"Assesses postural stability during walking tasks. This test is a modification of the Dynamic Gait Index (DGI) developed to improve reliability and decrease the ceiling effect.~10-item test that comprises 7 of the 8 items from the original DGI Eliminated 1 item from original DGI, ambulation around obstacles Added 3 new items to the original DGI, including gait with narrow base of support, ambulating backwards, and gait with eyes closed were added Each item is scored on an ordinal scale from 0 - 3, with 0 = severe impairment~= moderate impairment~= mild impairment~= normal ambulation Highest score = 30 Assessment may be performed with or without an assistive device"|Pre-training, Mid-training assessment (4 weeks), Post-training (8 weeks)||||units on a scale||Standard Deviation|Mean
2650101|NCT01672658|Primary|Berg Balance Scale|The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points. A score from 0 to 20 represents balance impairment, 21 to 40 represents acceptable balance, and 41-56 represents good balance.|Pre-training,Midpoint Assessment (4 weeks), Post Training (8 weeks)||||Units on a continuous scale||Standard Deviation|Mean
2650102|NCT01672294|Secondary|Caregiver Preparation|Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 5-item preparation subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).|Measured at baseline, 5 weeks, and 8 weeks|Comparing preparation scores between the Outlook Intervention and the Relaxation meditation arm, caregivers only. Two scale items were inadvertently left out initially. Items were added back in when omission was noted. However, the large number of missing makes analysis inappropriate.|||units on a scale||Standard Deviation|Mean
2650103|NCT01672294|Secondary|Prolonged Grief - Number of Participants With Anticipatory Grief|The Prolong Grief Disorder scale is a clinically-based diagnosis determination scale modified for this study. The components/requirements that were dropped were a) diagnosis should not be made until at least 6 months since death, and b) the disturbance is not better accounted for major depressive disorder, generalized anxiety disorder or post traumatic stress disorder. The outcome was a dichotomized variable with 1 indicating symptoms of prolonged grief are present and 0 indicating insufficient symptoms.|Measured at baseline, 5 weeks, and 8 weeks|Number of participants indicating prolonged grief across the Outlook Intervention and the Relaxation meditation arm, caregivers only. Only six percent of the sample qualified as having prolonged grief, at baseline. Therefore there was not sufficient data for statistical modeling.|||participants|||Number
2650104|NCT01672294|Secondary|Caregiver Completion|Quality of life at the End of Life (Family Edition) is a 17-item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 3-item Life Completion subscale uses a 5 point (0-4) Likert scale. The subscale ranges from 0 (poor) to 4 (better outcome).|Measured at baseline, 5 weeks, and 8 weeks|Comparing life completion scores between the Outlook Intervention and the Relaxation meditation arm, caregivers only. Differences in numbers analyzed versus group totals due to missing data.|||units on a scale||Standard Deviation|Mean
2650673|NCT01667224|Secondary|Changes in Abdominal Total Fat Area.|Abdominal total fat area was measured in study visit 1(0 week) and visit 4(12 week).|study visit 1(0 week), visit 4(12 week)||||cm^2||Standard Error|Mean
2650105|NCT01672294|Secondary|Caregiver Burden|Caregiver Reaction Assessment (CRA). The Caregiver Reaction Assessment is a 24-item multidimensional instrument designed to measure a caregiver's reactions to caregiving for family members with a variety of chronic illnesses. The esteem subscale has 7 items with a 5 level Likert scale: 1=Strongly Disagree to 5=Strongly Agree. The score is the average of the 7 items ranging from a low score of 1 associated with negative reactions and high score of 5 with positive reactions.|Measured at baseline, 5 weeks, and 8 weeks|Comparing Caregiver reaction assessment scores between the Outlook Intervention and the Relaxation Meditation arm.Differences in numbers analyzed versus group totals due to missing data.|||units on a scale||Standard Deviation|Mean
2650106|NCT01672294|Secondary|Patient Days of VA Hospital Use|The number of days that a patient used either the VA emergency department (ED) or was an inpatient at a VA hospital in the 6 months following randomization. Inclusion of non-VA utilization was made unpractical due to the long delay in filing for non VA reimbursement (up to 2 years). The original variable was Day AT home, defined to be 180 days minus the days in ED or inpatient hospital. This was changed to days of use due to distribution/modeling considerations.|In the 6 months after randomization||||Days in VA hospital or ER||Standard Deviation|Mean
2650107|NCT01672294|Secondary|Depression|Centers for Epidemiologic Study of Depression short form (CES-D) is a 10-item measure of depression. Items are rated on a 4 point Likert scale (0-3) with total scores ranging from 0 to 30. Higher scores indicate greater depressive symptoms|Measured at baseline, 5 weeks, and 8 weeks|Primary and secondary results are comparing caregiver scores in the two arms, not patient arms.|||units on a scale||Standard Deviation|Mean
2650108|NCT01672294|Secondary|Spirituality|Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-SP) subscale. The 12-item measure assess spiritual well-being: faith, meaning, and purpose. Individual items use a 5 point likert scale (0-4). The scale minimum score is 0 (negative well being) and maximum is 48 (positive well being).|Measured at baseline, 5 weeks, and 8 weeks|Comparing spiritual well being levels between the Outlook and the Relaxation meditation arms, Caregivers only.|||units on a scale||Standard Deviation|Mean
2650109|NCT01672294|Primary|Caregiver Anxiety|Profile of Moods States (POMS) anxiety sub-scale The anxiety sub-scale from the modified Brief Profile of Mood States (POMS),7110 a six-item measure of psychological distress. Individual items used a 5 point Likert scale (0-4). The sub-scale minimum score was 0 and maximum was 24 (more anxious ).|Measured at baseline, 5 weeks, and 8 weeks|Comparing Caregiver anxiety levels between the Outlook and the Relaxation meditation arm. Differences in numbers analyzed versus group totals due to missing data.|||units on a scale||Standard Deviation|Mean
2650110|NCT01672242|Primary|Change in End-expiratory Lung Volume|Change in end-expiratory lung volume from baseline arbitrarily set at 0 mL.|baseline and after 3-5 minutes after each level of flow or pressure||||mL||Standard Deviation|Mean
2650111|NCT01671839|Secondary|Safe Treatment|Freedom from serious adverse events directly attributable to the Cabochon System or procedure.|Treatment to 3 and 5 years||||occurence of serious adverse events|||Number
2650112|NCT01671839|Secondary|Procedure Tolerability|Subject rated pain according to a 0-10 numerical rating scale. Pain scale ranges from 0 (no pain) to 10 (worst possible pain). Measure was reported as mean and standard deviation of the pain score|Treatment to 3 and 5 years|The primary analysis was based upon the complete case population (CC).|||units on scale||Standard Deviation|Mean
2650113|NCT01671839|Secondary|Subject Satisfaction|"Subject rated satisfaction according to a 5 point Likert scale after treatment:~Very Satisfied Satisfied Neutral Unsatisfied Very Unsatisfied"|Treatment to 3 and 5 years|The primary analysis was based upon the complete case population (CC).|||percentage of subjects||95% Confidence Interval|Number
2650114|NCT01671839|Secondary|Improved Appearance|"Improvement in subject's cellulite appearance according to a Global Aesthetic Improvement Scale (GAIS) evaluated by independent and blinded physician panel assessment of subject photographs taken before and 3 and 5 years after treatment. Change in the cellulite severity was rated according to 5 measures:~Very much improved: Optimal cosmetic result in the treated areas for this subject~Much improved: Marked or significant improvement in appearance of the treated areas from the initial condition~Improved: Noticeable improvement in appearance of the treated areas from the initial condition but more subtle in magnitude~No Change: The appearance of the treated areas is essentially the same as the original condition~Worse: The appearance of the treated areas is worse than the original condition"|Treatment to 3 and 5 years|The primary analysis was based upon the complete case population (CC).|||percentage of subjects||95% Confidence Interval|Number
2650115|NCT01671839|Secondary|Improvement in Cellulite Severity Grade|Percentage of subjects which were scored to have improvement of one grade or more in a 4 point Severity Grade (none, mild, moderate, severe) as determined by independent blinded physician assessment of subject photographs taken before and 3 and 5 years after treatment.|3 and 5 years|The primary analysis was based upon the complete case population (CC). A supportive analysis was generated on the per-protocol (PP). Best-case, worst-case and multiple imputation techniques were utilized to impute missing endpoint outcomes.|||percentage of subjects||95% Confidence Interval|Number
2650116|NCT01671839|Primary|Mean Change (Decrease) in Cellulite Severity|Achievement of ≥1 point mean reduction in the 0-5 point Cellulite Severity Scale as determined by independent physician assessment of subject photographs taken before and 3 and 5 years after treatment. Cellulite severity was graded on a 0 (no cellulite) to 5 (severe cellulite) for each subject photograph taken at baseline (before treatment) and 3 and 5 years after treatment by an independent and blinded physician panel. The primary endpoint was achievement of a mean post-treatment severity at 3 and 5 years for the study population which was a minimum of 1 point lower than the baseline severity.|Treatment to 3 and 5 years|The primary analysis was based upon the complete case population (CC). A supportive analysis was generated on the per-protocol (PP). Best-case, worst-case and multiple imputation techniques were utilized to impute missing primary and powered secondary endpoint outcomes.|||units on a scale||95% Confidence Interval|Mean
2650117|NCT01671748|Secondary|Wound Recurrence Rate|Patients whose wound has healed (defined as 100% epithelialisation with no scab present) before or at the end of treatment will be asked 90 days after date of healing if their wound has remained closed.|90 days after time of healing|Three patients healed during the study period (one NLFU+SOC patient healed after 7 weeks and one after 8 weeks of NLFU+SOC treatment, and one patient who received standard care alone healed after 4 weeks). All three of these patients remained healed 90 days after the end of their study treatment.|||Number of wounds remained healed|||Number
2650122|NCT01671748|Secondary|Change in Overall Health Related Quality of Life (HRQoL) From Week 1 (Start) and Week 13 (Exit)|"On the first and final visit participants were invited to complete a Cardiff Wound Impact Schedule (CWIS) a validated questionnaire designed to measure the impact of chronic wounds on patient health-related quality of life (HRQoL). The overall HRQoL question asks patients to rate their overall quality of life over the past week by circling a number between 0 and 10. Low scores indicate poor quality of life, and high score indicate good quality of life. Change in HRQoL was calculated by subtracting week 1 values from week 13 values.~CWIS has been validated in the following paper: Price and Harding (2004) The Cardiff Wound Impact Schedule: the development of a condition specific questionnaire to assess health-related quality of life in patients with chronic wounds. International Wound Journal 1(1):10-17"|Week 1 (start) and week 13 (exit)|All patients were analysed by ITT|||units on a scale||Inter-Quartile Range|Median
2650123|NCT01671748|Primary|Percentage Change in Wound Area|Wound area is measured weekly using a digital wound imaging device. The wound boundary is digitally traced by a blinded assessor. Percentage and actual change in wound area between start of treatment (week 5) and end of treatment (week 13) is evaluated.|Week 5 to 13|All patients included in the analysis; Intention to treat (ITT); Values have been adjusted for the influence of the covariate (wound area at the start of treatment)|||percentage change in wound area||Standard Deviation|Mean
2650124|NCT01671605|Primary|In Vitro Lipoprotein Functions|Cholesterol efflux. Baseline and outcome measurements are the same. The cholesterol efflux was measured once using HDL isolated from CKD and control patients. There was no intervention,this assessment was performed once in each group. The measurement of cholesterol efflux is performed by an in vitro assay in cultured cells. Cells are loaded with cholesterol and maintained for 72 hours. The media of the cultured cells is then changed and the new media contains HDL from CKD or control patients. In additional cells, no HDL is added. The cells are maintained for 24 hours, and intracellular cholesterol is assessed. The cholesterol efflux represents the amount of cholesterol that was leached by HDL from each of our study groups. Thus, cells not exposed to any HDL will contain the highest intracellular cholesterol content. The amount of cholesterol in cells exposed to CKD HDL or control HDL reflects the efflux capacity of that HDL. This is expressed as percent of cholesterol removed by HDL.|Once, at enrollment||||Percentage of cholesterol content||Inter-Quartile Range|Median
2650125|NCT01671488|Secondary|To Evaluate Progression-free and Overall Survival for Patients With Anal Cancer Treated With ADXS11-001, Mitomycin, 5-FU and IMRT.|"Patients terminating study treatment early prior to disease recurrence will be followed every 6 months for year 1 then annually for a total of 5 years. The follow-up portion will commence once patient comes off study or post the 2-6 week post the 4th treatment time point/visit.~Assessments were tumor evaluation via sigmoidoscopy, proctoscopy, colonoscopy or anoscope and also chest/abdomen/pelvic imaging."|Follow up and survival status at 6 months and 1 year post coming off study and annually until patient has been off for 5 years|As one patient expired prior to 6 month assessment, the total n used was 9 to assess PFS|||Participants|||Count of Participants
2650126|NCT01671488|Primary|To Evaluate the 6-month Clinical Complete Response Rate for Patients With Anal Cancer Treated With ADXS11-001 Mitomycin, 5-FU and IMRT.|Patients to undergo tumor evaluation assessment (via sigmoidoscopy, proctoscopy, colonoscopy or anoscope) 6 months post the start of chemotherapy/radiation.|Tumor evaluation 6 months after coming off study|Number of patient's who received treatment on study|||Participants|||Count of Participants
2650127|NCT01671488|Primary|To Evaluate the Safety of the Addition of ADXS11-001 to Standard Chemoradiation for Patients With Anal Cancer.|Evaluate maximal toxicities via CTCAE version 4.0 All adverse events, serious and non-serious, were captured from date of ICF through 4 weeks post treatment completion- regardless of causality.|Baseline, then prior to each ADXS11-001 and weekly during radiation. Assessments 1-2 weeks post radiation then 2-6 weeks post vaccine and off study and 30 days post treatment.|Patient's who received treatment on study|||Participants|||Count of Participants
2650128|NCT01671345|Secondary|Hemoglobin A1c|Hemoglobin A1c (HgbA1c) is the blood test for assessing the control of diabetes over approximately three months preceding the test. HgbA1c is usually checked many times a year in patients with poorly controlled diabetes. Baseline HgbA1c in patients had to be ≥ 7.5.|At the baseline (Visit 1) and post-intervention (after Visit 2). All available values were restricted to one year before Visit 1 and from 30 days to one year past Visit 2.|Patients with type 2 diabetes at JBVAMC with HgbA1c more than or equal 7.5|||percent||Standard Deviation|Mean
2650129|NCT01671345|Secondary|Medication Adherence|"Patient adherence to medication was measured with: (1) Medical Outcome Study measure and (2) Morisky scale.~The Medical Outcome Study self-reported adherence to physicians' recommendations scale uses a brief questionnaire that asks whether respondents were adherent to physicians' recommendations and has scores ranging from 25 to 100. Higher numbers reflect better adherence.~The Morisky scale (4-item version) assesses self-reported medication adherence using yes or no questions to evaluate how a patient feels when they stop taking medication, if they feel hassled about taking medication, and if they have difficulty remembering to take their medication. The scores range form 0 to 4; higher numbers reflect better adherence."|Four weeks post-intervention (i.e. four weeks after Visit 2).|Patients with type 2 diabetes at JBVAMC with HgbA1c more than or equal to 7.5|||units on a scale||Standard Deviation|Mean
2650130|NCT01671345|Primary|Patients Active Participatory Communication Behaviors|"Active Participatory Communication Behavior (collected at visits 1 and 2) is derived from the content of audio recordings of the physician-patient visits.~Active participatory communication behaviors include four essential elements:~telling a medical history;~asking questions;~being assertive or making requests, and~communication concerns. We coded patients' active participatory communication behaviors from the audio recording by classifying patients' statements into utterances. An utterance is the unit of analysis for coding the different types of behaviors into the communication categories. Utterances are coded according to the categories of active participatory communication behavior. Once classified, communicative behaviors are summed. The higher number means more active communication."|at the baseline ( Visit 1) and post-intervention (Visit 2)|Patients with type 2 diabetes at JBVAMC with HgbA1c more than or equal 7.5|||utterances||Standard Deviation|Mean
2650157|NCT01671085|Secondary|PK: Area Under the Concentration Curve During One Dosing Interval (AUCt) of LY3015014|The AUCt was calculated after each dose of LY3015014.|Day 1 and 29: 4 h and 24 h postdose|FAS: Data from all randomized participants who received at least 1 dose of study drug according to the treatment the participants actually received and had evaluable PK data for AUCt.|||microgram*hour per milliliter (µg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2650131|NCT01671345|Primary|Patients' Perceived Self-efficacy to Communicate|Communication Self-Efficacy is the degree to which a patient feels able to interact with his/her physician in order to provide information about problems, obtain desired information about diagnosis, treatment and prognosis, and participate in formulating a plan. Self Efficacy to Communicate is measured with the Perceived Efficacy in Physician Patient Interactions scale - a valid and reliable self report measure of patients' perceived self efficacy in interacting with physicians. Scores ranging from 5 to 25 are used; higher numbers reflect more perceived self-efficacy in interacting with physicians.|at the baseline ( Visit 1) and post-intervention (Visit 2)|Patients with type 2 diabetes and with HgbA1c more than or equal to 7.5|||units on a scale||Standard Deviation|Mean
2650132|NCT01671319|Secondary|Incidence of Neuropathy|Neuropathy was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy.|Up to 10 weeks|Of 42 participants, 41 were evaluable for outcome measure analysis.|||Participants|||Count of Participants
2650133|NCT01671319|Secondary|Incidence of Febrile Neutropenia|Neutropenic fever was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy.|Up to 10 weeks|Of 42 participants, 41 were evaluable for outcome measure analysis.|||Participants|||Count of Participants
2650134|NCT01671319|Primary|Feasibility for Dose-dense TC Therapy: Number of Participants Receiving at Least 90% of Total Dose of Therapy|Evaluate feasibility of delivering 4 cycles (1 cycle = 2 weeks) of docetaxel and cyclophosphamide (TC) on a dose-dense (q2week) schedule with pegfilgrastim support. This regimen will be referred to as dose-dense (dd)TC. Feasibility defined by at least 60% of patients receiving 90% of the total dose of therapy within 10 weeks.|4 cycles each 2 weeks in length for a total of 8 weeks, up to 10 weeks|Of 42 participants, 41 were evaluable for outcome measure analysis.|||participants|||Number
2650135|NCT01671293|Secondary|Change of Baseline in Waist Circumference|Participants' waist circumference will be measured in centimeters using a measuring tape. The circumference will be measured at the highest part of the iliac crest (The Canadian Physical Activity, Fitness and Lifestyle approach, 2010)|baseline and post intervention (6 -9 months after the first phone counseling session)|||||||
2650136|NCT01671293|Secondary|Change of Baseline in Knowledge About Prediabetes|A self-report questionnaire was developed to measure patients' knowledge about prediabetes, the risk factors for its appearance, and its treatment (or management). Is is made up by 18 items in which the person must say whether the statement presented is true or false. In addition, the instrument measures the subjective perception of the risk of developing diabetes (one item).|baseline and post intervention (6 -9 months after the first phone counseling session)|||||||
2650137|NCT01671293|Secondary|Change From Baseline in Self Report of Dietary Practices|The dietary practices reported by the participants will be measured with an instrument designed with this purpose in mind as part of the present study. The instrument is constituted by 17 items aimed at measuring the frequency of healthy and unhealthy eating. It was constructed on the basis of items present in the Diabetes Self Care Activities Measure (Toobert, Hampson, & Glasgow, 2000) and of others created by the Stanford Patient Education Research Center. Some of these items were used to measure dietary practices in Chilean populations diagnosed with Diabetes Mellitus (Lange et al., 2010)|baseline and post intervention (6 -9 months after the first phone counseling session)|||||||
2650138|NCT01671293|Secondary|Change From Baseline in Total Cholesterol|"It will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:~Method: Colorimetric - CHOD/PAP.Equipment: Siemens Dimension RXL. Normal Range: ≤ 200 mg/dL"|baseline and post intervention (6 -9 months after the first phone counseling session)|||||||
2650139|NCT01671293|Secondary|Change From Baseline in Triglycerides|"It will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:~Method:Colorimetric - GPO/PAP blank glycerol. Equipment: Siemens Dimension RXL. Normal Range: ≤ 150 mg/dL."|baseline and post intervention (6 -9 months after the first phone counseling session)|||||||
2650140|NCT01671293|Secondary|Change From Baseline in Fasting Glucose|"Fasting Glucose will be measured through a blood sample. The samples will be processed by the Municipal Laboratory (Laboratorio Comunal), following the standard procedures established by their protocols:~Method:Colorimetric - Hexokinase / Glucose 6-phosphate-DH. UV. Equipment: Siemens Dimension RXL. Normal Range: 70-100 mg/dL."|baseline and post intervention (6 -9 months after the first phone counseling session)|||||||
2650141|NCT01671293|Secondary|Change From Baseline in Self Report of Physical Activity|The level of physical activity reported by participants is measured using the Rapid Assessment Physical Activity Scale (RAPA; Tolpolski et al., 2006), in its version adapted for Chile. This instrument is made up by 9 dichotomous questions, which point to a physical activity level corresponding to the following categories: sedentary, under-active, under-active regular-light activities, under-active regular, and active, depending on the frequency and intensity of the physical activity done. The instrument adaptation process of the instrument is conducted as part of the present study.|baseline and post intervention (6 -9 months after the first phone counseling session)|||||||
2650142|NCT01671293|Primary|Change From Baseline in Weight Parameter|Patient's weight wil be measured in kilograms using scales.|baseline and post intervention (6 -9 months after the first phone counseling session)||||kilograms||Standard Deviation|Mean
2650143|NCT01671280|Secondary|Clinical Effectiveness Rate in Participants With Pelvic Inflammatory Disease|Clinical effectiveness rate in pelvic inflammatory disease (PID), which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with PID, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.|29 days|"The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation of PID (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as unassessable were excluded from the calculation."|||Percentage of Participants||95% Confidence Interval|Number
2650674|NCT01667224|Primary|Changes in Body Fat Mass.|Body fat mass was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).|study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)||||kg||Standard Error|Mean
2650144|NCT01671280|Secondary|Clinical Effectiveness Rate in Participants With Pneumonia|Clinical effectiveness rate in participants with pneumonia, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with pneumonia, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.|29 days|"The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation of pneumonia (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as unassessable were excluded from the calculation."|||Percentage of Participants||95% Confidence Interval|Number
2650145|NCT01671280|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to Zithromac Intravenous use (and Zithromac Tablets) in a participant who received Zithromac Intravenous use (and Zithromac Tablets). A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Zithromac Intravenous use (and Zithromac Tablets) was assessed by the physician.|29 days|The safety analysis set comprised of participants who satisfied the inclusion criteria and received Zithromac Intravenous use at least once.|||Participants|||Number
2650146|NCT01671176|Primary|Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane|Presently, the recommendations to load the sound processor on a bone anchored implant is 3 months (for adults). Using outcome measures, i.e., OSSTELL ISQ ranges from 0 -100 where 0 is least stable and 100 being the most stable.|At surgery, 1 week, 3 weeks, 6 weeks, 12 weeks, 6 months and 12 months||||units on a scale||Standard Deviation|Mean
2650147|NCT01671176|Primary|Holger's Scale|Holger's Scale is a 5 point that ranges from 0 - 4 scale that assesses skin reactions at the implant site where 0 means no reaction and 4 means excessive granulation, skin overgrowth, or scar formation requiring revision surgery|1 week, 3 weeks, 6 weeks, 3 months, 6 months and 12 months||||participants|||Number
2650148|NCT01671111|Secondary|Change From Baseline in Serum Ferritin Values at Specified Visits|A negative change from baseline indicates that serum ferritin decreased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Weeks 24 and 48 of Cycle 1, Week 24 of Cycle 2|FAS. Here, 'n' signifies the number of FAS participants evaluable for the respective time points.|||nanogram per milliliter||Standard Deviation|Mean
2650149|NCT01671111|Primary|Change From Baseline in Cardiac T2* Values at Week 24 (Cycle 2)|The efficacy of SSP-004184 was assessed by determining cardiac iron load. Cardiac MRI data were collected by using T2* standard procedures and used to determine iron load. A negative change from baseline indicates that iron load increased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 24 (Cycle 2)|FAS participants evaluable for this outcome.|||milliseconds||Standard Deviation|Mean
2650150|NCT01671111|Primary|Change From Baseline in Cardiac T2* Values at Week 48 (Cycle 1)|The efficacy of SSP-004184 was assessed by determining cardiac iron load. Cardiac MRI data were collected by using T2* standard procedures and used to determine iron load. A negative change from baseline indicates that iron load increased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 48 (Cycle 1)|FAS participants evaluable for this outcome.|||milliseconds||Standard Deviation|Mean
2650151|NCT01671111|Primary|Change From Baseline in Cardiac T2* Values at Week 24 (Cycle 1)|The efficacy of SSP-004184 was assessed by determining cardiac iron load. Cardiac MRI data were collected by using T2* standard procedures and used to determine iron load. A negative change from baseline indicates that iron load increased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 24 (Cycle 1)|FAS. Here, 'n' signifies the number of FAS participants evaluable for the respective time points.|||milliseconds||Standard Deviation|Mean
2650152|NCT01671111|Primary|Change From Baseline in Ferriscan® R2 Liver Iron Concentrations (LIC) at Week 24 (Cycle 2)|Efficacy of SSP-004184 was assessed by determining LIC. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 24 (Cycle 2)|FAS participants evaluable for this outcome.|||mg/g dry tissue||Standard Deviation|Mean
2650153|NCT01671111|Primary|Change From Baseline in Ferriscan® R2 Liver Iron Concentrations (LIC) at Week 48 (Cycle 1)|Efficacy of SSP-004184 was assessed by determining LIC. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 48 (Cycle 1)|FAS participants evaluable for this outcome.|||mg/g dry tissue||Standard Deviation|Mean
2650154|NCT01671111|Primary|Change From Baseline in Ferriscan® R2 Liver Iron Concentrations (LIC) at Week 24 (Cycle 1)|Efficacy of SSP-004184 was assessed by determining LIC. Abdominal magnetic resonance imaging (MRI) data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. A cycle consisted of 8 standard 6-weekly visits and the cycles were repeated each year for the duration of the study.|Baseline, Week 24 (Cycle 1)|Full analysis set (FAS) included all participants in the Safety set who had at least 1 post-baseline primary efficacy assessment. Here, 'n' signifies the number of FAS participants evaluable for the respective time points.|||milligram per gram (mg/g) dry tissue||Standard Deviation|Mean
2650155|NCT01671085|Secondary|Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)|Percentage change from baseline in LDL-C was calculated as Least Squares (LS) mean using mixed model repeated measures (MMRM) analysis adjusted for baseline measurement. Treatment, day after dosing, and treatment-by-day interaction were included in the model.|Baseline, Day 43 and Day 57|Pharmacodynamic analyses set: Participants who received at least 1 dose of investigational product according to the treatment actually received and had a baseline measurement and at least 1 post baseline measurement for LDL-C.|||µg/mL||90% Confidence Interval|Least Squares Mean
2650158|NCT01671085|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014|The Cmax was calculated after each dose of LY3015014.|Day 1 and 29: 4 hours (h) and 24 h postdose|Full analysis set (FAS): Data from all randomized participants who received at least 1 dose of the study drug according to the treatment the participants actually received and had evaluable PK data for Cmax.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2650159|NCT01671085|Primary|Number of Participants With One or More Other Non-Serious Adverse Events (AEs) or Any Serious AEs (SAEs)|Events deemed to be SAEs by the Investigator as related to study drug administration were collected during the study and 30 days following study drug administration. A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline through study completion (Day 127)|All enrolled participants.|||Participants|||Count of Participants
2650160|NCT01671059|Secondary|Visual Analogue Scale (VAS) for Pain|The VAS-Pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.|6 months|Enrolled participants who were evaluable for this outcome measure.|||units on a scale||Full Range|Median
2650161|NCT01671059|Secondary|Visual Analogue Scale (VAS) for Morning Stiffness|Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.|6 months|Enrolled participants who were evaluable for this outcome measure.|||units on a scale||Full Range|Median
2650162|NCT01671059|Secondary|Visual Analogue Scale (VAS) for Fatigue|The VAS-fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue, and 100 indicates extreme fatigue. A decrease in the score indicates improvement.|6 months|Enrolled participants who were evaluable for this outcome measure.|||units on a scale||Full Range|Median
2650163|NCT01671059|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ is a participant self-reported questionnaire for assessing the extent of the participant's functional ability. It consists of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question has 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ scale is an average of all the scores and ranges from 0 to 3, where higher scores represent higher disease activity.|6 months|Enrolled participants who were evaluable for this outcome measure.|||units on a scale||Full Range|Median
2650164|NCT01671059|Secondary|Patient Global Assessment of Disease Activity Score|The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.|6 months|Enrolled participants who were evaluable for this outcome measure.|||units on a scale||Full Range|Median
2650165|NCT01671059|Secondary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESIs)|An AESI includes serious/medically significant infections; opportunistic infections; cases of elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST), in combination with either elevated bilirubin or clinical jaundice; suspected transmission of an infectious agent by the study drug; myocardial infarction /acute coronary syndrome; gastrointestinal perforations; malignancies; anaphylaxis / hypersensitivity reactions (including injection site reactions); demyelinating disorders; stroke; serious/medically significant bleeding events; or serious/medically significant hepatic events.|6 months|Enrolled participants.|||percentage of participants|||Number
2650166|NCT01671059|Secondary|Percentage of Participants With American College of Rheumatology (ACR) Response|ACR response was calculated based on total joint count evaluation and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (28 joints) and tender joint count (28 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, participant's global assessment of disease activity (PGH), physician's global assessment of disease activity (PhGH) (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale); participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity); acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement. ACR50 and ACR70 require a 50% and 70% improvement from baseline, respectively.|6 months|Enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2650167|NCT01671059|Secondary|Clinical Disease Activity Index (CDAI) Score|Clinical Disease Activity Index (CDAI) is an index for measuring disease activity in RA. The index was calculated using the following formula: CDAI = number of swollen joints using the 28-joint count (SJC28) + number of tender joints using the 28-joint count (TJC28) + patient global assessment of disease (PGA) based on 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) based on 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Total CDAI scores range from 0 to 76, with higher scores indicating increased disease activity.|6 months|Enrolled participants who were evaluable for this outcome measure.|||units on a scale||Full Range|Median
2650168|NCT01671059|Secondary|Simplified Disease Activity Index (SDAI)|Simplified Disease Activity Index (SDAI) is an index for measuring disease activity in RA and has a good correlation with the DAS28. The index is calculated using the following formula: SDAI: swollen joint count (SJC28) + tender joint count (TJC28) + physician global assessment (PGA) (10 cm visual analogue scale [VAS]) + PhGA (10 cm VAS + C-Reactive Protein (CRP) in milligrams/liter (mg/L). VAS assessments involved a 10 cm horizontal scale from 0 (no disease activity) to 10 (maximum disease activity). Scores range from 0 to 86, with higher scores also indicating increased disease activity.|6 months|Enrolled participants who were evaluable for this outcome measure.|||units on a scale||Full Range|Median
2650272|NCT01669902|Secondary|Percentage of Participants With Morning Stiffness|"The percentage of participants with morning stiffness (yes, no, or do not know) was assessed at each visit."|Baseline, Month 3, Month 6|FAS (morning stiffness) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or 6) for morning stiffness. n = participants evaluable for this measure at specified timepoint.|||percentage of participants|||Number
2650169|NCT01671059|Secondary|Percentage of Participants on Monotherapy Achieving a Response by European League Against Rheumatism (EULAR) Category|Percentage of participants achieving a response by EULAR category, including moderate, good, or no response. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline <-1.2 with a DAS28 score ≤3.2; Moderate response: change from baseline <-1.2 with DAS28 scores >3.2 to ≤ 5.1 or >5.1, or a change from baseline <-0.6 to ≥-1.2 with DAS28 scores ≤3.2 and >3.2 to ≤5.1; No response: change from baseline <-0.6 to ≥-1.2 with DAS28 score >5.1, or a change from baseline ≥-0.6 with DAS28 scores ≤3.2, >3.2 to ≤ 5.1, or >5.1.|6 months|Enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2650170|NCT01671059|Secondary|Percentage of Participants on Combination Therapy Achieving a Response by European League Against Rheumatism (EULAR) Category|Percentage of participants achieving a response by EULAR category, including moderate, good, or no response. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good response: change from baseline <-1.2 with a DAS28 score ≤3.2; Moderate response: change from baseline <-1.2 with DAS28 scores >3.2 to ≤ 5.1 or >5.1, or a change from baseline <-0.6 to ≥-1.2 with DAS28 scores ≤3.2 and >3.2 to ≤5.1; No response: change from baseline <-0.6 to ≥-1.2 with DAS28 score >5.1, or a change from baseline ≥-0.6 with DAS28 scores ≤3.2, >3.2 to ≤ 5.1, or >5.1.|6 months|Enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2650171|NCT01671059|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR; in millimeters per hour [mm/hour]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog assessment [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.|6 months|Enrolled participants who were evaluable for this outcome measure.|||units on a scale||Full Range|Median
2650172|NCT01671059|Secondary|Percentage of Participants on Tocilizumab Monotherapy at Study Entry||6 months|Enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2650173|NCT01671059|Secondary|Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy||6 months|Enrolled participants.|||percentage of participants|||Number
2650174|NCT01671059|Secondary|Percentage of Participants With Dose Interruptions||6 months|Enrolled participants.|||percentage of participants|||Number
2650175|NCT01671059|Secondary|Reasons for Dose Modifications||6 months|Enrolled participants who were evaluable for this outcome measure.|||participants|||Number
2650176|NCT01671059|Secondary|Percentage of Participants Receiving Tocilizumab After Failing Other Biologic Agents||Baseline|Enrolled participants.|||percentage of participants|||Number
2650177|NCT01671059|Secondary|Percentage of Participants Receiving Tocilizumab After Failing Disease-Modifying Anti-Rheumatic Drugs (DMARDs)||6 months|Enrolled participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2650178|NCT01671059|Secondary|Percentage of Participants With Dose Modifications||6 months|Enrolled participants.|||percentage of participants|||Number
2650179|NCT01671059|Primary|Percentage of Participants on Tocilizumab 6 Months After Treatment Initiation||6 months|Enrolled participants.|||percentage of participants|||Number
2650180|NCT01670825|Secondary|Disability Due to Headaches 6 Months After the Start of Treatment Measured Using the Headache Impact Scale|This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.|From baseline to 6 months after the start of treatment||||units on a scale||Standard Deviation|Mean
2650181|NCT01670825|Secondary|Disability Due to Headaches 3 Months After the Start of Treatment Measured Using the Headache Impact Scale|This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.|From baseline to 3 months after the start of treatment||||units on a scale||Standard Deviation|Mean
2650182|NCT01670825|Secondary|Disability Due to Headaches 6 Weeks After the Start of Treatment Measured Using the Headache Impact Scale|This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.|From baseline to 6 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
2650183|NCT01670825|Secondary|Severe Headache Frequency for Occipital Neuralgia Headaches 6 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit|This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.|From baseline to 6 months after the start of treatment||||days||Standard Deviation|Mean
2650184|NCT01670825|Secondary|Severe Headache Frequency for Migraine Headaches 6 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit|This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 6 month follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.|From baseline to 6 months after the start of treatment||||days||Standard Deviation|Mean
2650273|NCT01669902|Secondary|Patient Global Assessment of Pain|Patient Global Assessment of Pain was assessed using a 100 mm VAS (0 to 100) where 0 = no pain to 100 = worst possible pain.|Baseline, Month 3, Month 6|The FAS (VAS pain) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS pain. n = participants evaluable for this measure at specified timepoint.|||mm||Standard Deviation|Mean
2650185|NCT01670825|Secondary|Severe Headache Frequency for Occipital Neuralgia Headaches 3 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit|This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.|3 months||||days||Standard Deviation|Mean
2650186|NCT01670825|Secondary|Severe Headache Frequency for Migraine Headaches 3 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit|This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 3 month follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.|From baseline to 3 months after the start of treatment||||days||Standard Deviation|Mean
2650187|NCT01670825|Secondary|Severe Headache Frequency for Occipital Neuralgia Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit|This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.|From baseline to 6 weeks after the start of treatment||||days||Standard Deviation|Mean
2650188|NCT01670825|Secondary|Severe Headache Frequency for Migraine Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headaches in the Past Week.|This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.|From baseline to 6 weeks after the start of treatment||||days||Standard Deviation|Mean
2650189|NCT01670825|Secondary|Change in the Severity of Depression 6 Months After the Start of Treatment Measured Using the Beck's Depression Inventory|This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.|From baseline to 6 months after the start of treatment||||units on a scale||Standard Deviation|Mean
2650190|NCT01670825|Secondary|Change in the Severity of Depression 3 Months After the Start of Treatment Measured Using the Beck's Depression Inventory|This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.|From baseline to 3 months after the start of treatment||||units on a scale||Standard Deviation|Mean
2650191|NCT01670825|Secondary|Change in the Severity of Depression 6 Weeks After the Start of Treatment Measured Using the Beck's Depression Inventory|This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.|From baseline to 6 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
2650192|NCT01670825|Secondary|Change in the Presence of Insomnia 6 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.|This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.|From baseline to 6 months after the start of treatment||||units on a scale||Standard Deviation|Mean
2650193|NCT01670825|Secondary|Change in the Presence of Insomnia 3 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.|This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.|From baseline to 3 months after the start of treatment||||units on a scale||Standard Deviation|Mean
2650194|NCT01670825|Secondary|Change in the Presence of Insomnia 6 Weeks After the Start of Treatment Measured Using the Athens Insomnia Scale.|This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.|From baseline to 6 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
2650195|NCT01670825|Primary|Change in Overall Worst Headache Pain 6 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 months after the start of treatment||||units on a scale||Standard Deviation|Mean
2650196|NCT01670825|Primary|Change in Overall Average Headache Pain 6 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 months after the start of treatment||||units on a scale||Standard Deviation|Mean
2650197|NCT01670825|Primary|Change in Overall Worst Headache Pain 3 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 3 months after the start of treatment||||units on a scale||Standard Deviation|Mean
2650722|NCT01666782|Secondary|The Seroprotection Rate of High-dose Influenza Vaccine vs Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.|Seroprotection rate was defined as the percentage of patients with a HAI GMT of at least 1:40 28 days after vaccination.|28 days||||percentage of participants|||Number
2650198|NCT01670825|Primary|Change in Overall Average Headache Pain 3 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 3 months after the start of treatment||||units on a scale||Standard Deviation|Mean
2650199|NCT01670825|Primary|Change in Overall Worst Overall Headache Pain 6 Weeks After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
2650200|NCT01670825|Primary|Change in Overall Average Headache Pain 6 Weeks After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
2650201|NCT01670825|Primary|Change in Overall Worst Headache Pain 2 Weeks After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 2 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
2650202|NCT01670825|Primary|Change in Overall Average Headache Pain 2 Weeks After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 2 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
2650203|NCT01670825|Primary|Change in Worst Occipital Pain 2 Weeks After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 2 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
2650204|NCT01670825|Primary|Change in Average Occipital Pain 2 Weeks After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 2 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
2650205|NCT01670825|Primary|Change in Worst Occipital Pain 3 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 3 months after the start of treatment||||units on a scale||Standard Deviation|Mean
2650206|NCT01670825|Primary|Change in Average Occipital Pain 3 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 3 months after the start of treatment||||units on a scale||Standard Deviation|Mean
2650207|NCT01670825|Primary|Change in Worst Occipital Pain 6 Months After the Start of Treatment|This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 months after the start of treatment||||units on a scale||Standard Deviation|Mean
2650208|NCT01670825|Primary|Change in Average Occipital Pain 6 Months After the Start of Treatment|The change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 months after the start of treatment||||units on a scale||Standard Deviation|Mean
2650209|NCT01670825|Primary|Change in Worst Occipital Pain 6 Weeks After the Start of Treatment|The change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
2650210|NCT01670825|Primary|Change in Average Occipital Pain 6 Weeks After the Start of Treatment|The change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.|From baseline to 6 weeks after the start of treatment||||units on a scale||Standard Deviation|Mean
2650276|NCT01669902|Secondary|Patient Global Assessment (PtGA) of Disease Activity Score|Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.|Baseline, Month 3, Month 6|The FAS (VAS disease activity [patient]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS disease activity (patient). n = participants evaluable for this measure at specified timepoint.|||mm||Standard Deviation|Mean
2650211|NCT01670721|Secondary|Change From Baseline in HRQL EQ-5D-3L VAS Score|EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. Baseline corresponded to last evaluable assessment before treatment administration.|Pre-dose at Baseline, Day 1 of every odd cycle; and at end of treatment (30 days after last study treatment) (maximum exposure: 99 weeks)|EQ-5D analysis population: participants who signed informed consent form, had an evaluable EQ-5D questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment (either Aflibercept or FOLFIRI).Here, n = number of participants with available data at specified time-points.|||units on a scale||Standard Deviation|Mean
2650212|NCT01670721|Secondary|Change From Baseline in HRQL European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Score|EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D descriptive system comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on 3 levels (no problem, some problems & severe problems) within a particular EQ-5D dimension. 5 dimensional 3-level system was converted into single index utility score. Possible values for single index utility score ranged from -0.594 (severe problems in all dimensions) to 1.0 (no problem in all dimensions) on scale where 1 represented best possible health state.|Pre-dose at Baseline, Day 1 of every odd cycle; and at end of treatment (30 days after last study treatment) (maximum exposure: 99 weeks)|EQ-5D analysis population: participants who signed informed consent form, had an evaluable EQ-5D questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment (either Aflibercept or FOLFIRI).Here, n = number of participants with available data at specified time-points.|||units on a scale||Standard Deviation|Mean
2650213|NCT01670721|Secondary|Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)|EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) & other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health & quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.|Pre-dose at Baseline, Day 1 of every odd cycle; and at end of treatment (30 days after last study treatment) (maximum exposure: 99 weeks)|EORTC QLQ-C30 analysis population: participants who signed informed consent form; had an evaluable QLQ-C30 questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment(either Aflibercept or FOLFIRI).Here, n=number of participants with available data at specified time-points.|||units on a scale||Standard Deviation|Mean
2650214|NCT01670721|Primary|Percentage of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period. On-treatment period was defined as the time from the first dose of treatment to 30 days after the last dose of treatment (either Aflibercept or FOLFIRI). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline upto 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure:723 days)|Safety population defined as the participants who signed the informed consent form and received at least part of one dose of study treatment.|||Percentage of participants|||Number
2650215|NCT01670656|Secondary|Change From Baseline in Number of Days of Ibuprofen Intake Through Cycle 2|Participants were provided with ibuprofen 400 mg tablets at the screening visit to be taken throughout the study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose was 3200 mg (8 tablets). Participants were instructed to take the provided ibuprofen, and no other medications, for the relief of menstrual cramping pain, and to record their ibuprofen usage in their e-Diaries.|Baseline and Day 29 to 56 (Cycle 2)|All randomized participants in whom a vaginal ring was inserted and who had at least one baseline or one post-baseline value for Number of Days of Ibuprofen Intake|||Days of ibuprofen intake||95% Confidence Interval|Least Squares Mean
2650216|NCT01670656|Secondary|Change From Baseline in Number of Ibuprofen Tablets Taken Through Cycle 2|Participants were provided with ibuprofen 400 mg tablets at the screening visit to be taken throughout the study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose was 3200 mg (8 tablets). Participants were instructed to take the provided ibuprofen, and no other medications, for the relief of menstrual cramping pain, and to record their ibuprofen usage in their e-Diaries.|Baseline and Day 29 to 56 (Cycle 2)|All randomized participants in whom a vaginal ring was inserted and who had at least one baseline or one post-baseline value for Number of Ibuprofen Tablets Taken|||Ibuprofen tablets||95% Confidence Interval|Least Squares Mean
2650217|NCT01670656|Secondary|Change From Baseline in Total Mean Impact Score Through Cycle 2|"Total Mean Impact Score is the mean of the sum of the daily responses to questions 6, 8, 9, and 10 in the Dysmenorrhea Daily e-Dairy, as recorded within the menstrual cramping pain analysis window. These questions assessed how much interference there was from pelvic cramping pain on work/school activities (Q6), physical activities (Q8), social/leisure activities (Q9) and sleep (Q10). Each question was rated on a 5-point (0-4) scale, with 0 being not at all, 1 slightly, 2 moderately, 3 quite a bit and 4 extremely. The total mean impact score could thus range from 0 (lowest possible impact) to 16 (highest possible impact)."|Baseline and Day 29 to 56 (Cycle 2)|All randomized participants in whom a vaginal ring was inserted and who had at least one baseline or one post-baseline value for Total Mean Impact Score|||Units on a scale||95% Confidence Interval|Least Squares Mean
2650218|NCT01670656|Primary|Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2|"The Mean Menstrual Cramping Pain score was calculated as the average of the three highest daily menstrual cramping scores (item #3 of the Menstrual Distress Questionnaire: Cramps) in the baseline cycle and treatment Cycle 2, respectively. The daily menstrual cramping pain score was based on five pain categories: none (0); mild (1); moderate (2); strong (3); and severe (4). In case of absence of withdrawal bleeding, or onset of menstruation, the mean of the three highest menstrual cramping pain scores recorded within Days 21-28 was used for analysis. The Mean Menstrual Cramping Pain Score in the baseline or subsequent cycles could range from 0 (none) to 4 (severe)."|Baseline and Day 29 to 56 (Cycle 2)|All randomized participants in whom a vaginal ring was inserted and who had at least one baseline or one post-baseline value for Menstrual Cramping Pain Score|||Units on a scale||95% Confidence Interval|Least Squares Mean
2650219|NCT01670526|Secondary|Twelve-week Change in Beck Depression Inventory-II (BDI-II)|"Beck Depression Inventory-II (BDI-II) is a validated 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depressive symptoms. Each answer is scored on a scale value of 0 to 3. Higher score indicates more severe depression.~To compare the differences in mean changes of BDI-II between two groups using two groups from baseline to week 12."|12 week||||units on a scale||Standard Deviation|Mean
2650220|NCT01670526|Secondary|Twelve-week Change in The PTSD Symptom Checklist-Military Version (PCL-M)|"PCL-M is a validated 17-item self-report measure of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) symptoms of PTSD.The PCL-M asks about problems in response to stressful military experiences. Items are rated on a 5-point scale ranging from 1 (not at all) to 5 (extremely). Higher score indicates more stressful.~Comparison of difference in mean changes of PCL-M from baseline to 12-week follow-up between two groups."|12 week||||units on a scale||Standard Deviation|Mean
2650221|NCT01670526|Secondary|Twelve-week Change in University of California San Diego Performance-based Skills Assessment - Brief (UPSA-B)|UPSA-B is a validated performance-based measure to evaluate the impact of rivastigmine-mediated memory improvements on the ability to perform tasks required for day-to-day functioning in two subdomains of financial management and communication. The scale goes from (0-100) and high score indicates better functions. Comparison of difference in mean changes of UPSA-B from baseline to 12-week follow-up between two groups.|12 weeks|Participants complete 12 weeks follow up included in this analysis.|||units on a scale||Standard Deviation|Mean
2650222|NCT01670526|Primary|Number of Participants With Demonstrated Improvement From Baseline on the Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall|The primary efficacy measure was the Hopkins Verbal Learning Test - Revised (HVLT-R) Total Recall Index. HVLT-R was administered at screen, baseline, weeks 4, and 12. The HVLT is a measure that assesses verbal learning and memory. Alternate versions of the HVLT-R were administered at each of the different time points. The test consists of 12 words which are read to participants for three consecutive trials, each trial followed by free recall. The Total Recall score is the total number of words recalled over the three trials. The primary endpoint evaluation was to compare the proportion of patients who demonstrated improvement from baseline on the HVLT-R Total Recall of at least 5-word and at week 12 between the treatment and placebo group.|week 12||||Participants|||Count of Participants
2650223|NCT01670487|Primary|Pain Score on the Numeric Rating Scale (NRS)|Numeric rating scale (NRS) 0-10 : 0 (no pain) - 5 (moderate pain) - 10 (worst pain). Scores to be utilized after stream device applied and after intravenous catheter placement.|pain of intravenous catheter placement.|adults undergoing placement of an intravenous line in the emergency department|||NRS||Standard Deviation|Mean
2650224|NCT01670292|Secondary|Bothersomeness|"Question asked of participants: During the past week, how bothersome have each of the following symptoms been? The bothersomeness questionnaire contains two items: a) low back pain & b) leg pain (sciatica).~Scale: 0-10 (anchors: 0 = Not at all bothersome, 10 = Extremely bothersome)"|Baseline, 2 weeks, 6 weeks|Note: 82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively. Number of observations made at the three time points were 82, 70, and 68, respectively.|||units on a scale||Standard Deviation|Mean
2650225|NCT01670292|Secondary|PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: Global Item, Pain NRS|1) The PROMIS questionnaire contains 1 PROMIS global item: Pain NRS, Scale: 0-10 (anchors: 0 = No Pain, 10 = Worst Imaginable Pain, higher score is worse). The PROMIS global item is not scored but reported in raw score.|Baseline, 2 weeks, 6 weeks|Note: 82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively. Number of observations made at the three time points were 82, 70, and 68, respectively.|||units on a scale||Standard Deviation|Mean
2650226|NCT01670292|Secondary|PROMIS-29 - Patient Reported Outcomes Measurement Information Scale-29: General Health Status Scale|"1) The questionnaire contains 7 PROMIS-29 specific items: Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction with Participation in Social Role (anchors: 1= 'Not at all', 5= 'Very much', higher score is worse).~Each PROMIS-29 specific item is reported in raw score (4-20) and scored in T-score (T), which rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10 for a population.~On the T-score metric & interpretation:~A score of 40 is one SD lower than the mean of the reference population.~A score of 60 is one SD higher than the mean of the reference population.~For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population. This could be a desirable or undesirable outcome, depending upon the concept being measured."|Baseline, 2 weeks, 6 weeks|Note: 82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively. Number of observations made at the three time points were 82, 70, and 68, respectively.|||T-score||Standard Deviation|Mean
2650274|NCT01669902|Secondary|Percentage of Participants in a PGA of Disease Activity Score Category|A categorical scale (Lickert scale) with the following categories: none, mild, moderate, severe and maximal was used to evaluate disease activity in clinical practice.|Baseline, Month 3, Month 6|FAS (categorical scale [physician]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for rheumatoid arthritis illness categorical scale (physician). n = participants evaluable for this measure at specified timepoint.|||percentage of participants|||Number
2657186|NCT01607853|Secondary|Change From Baseline in Scaling at Day 4|Investigator's rating of the clinical appearance of scaling. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 4||||units on a scale||Standard Deviation|Mean
2650227|NCT01670292|Secondary|Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Moment|"SSL* contains variables: rate of loading for moment in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C).~*Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal.~Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6."|6 weeks|Note: 82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively, and a total of 593 SM was delivered during visits 1, 5, and 12. The number of observations for individual measures is lower than the total number of analyzable SM (n=575) due to missing data in corresponding components.|||Newton*Meters/second|Spinal Manipulations|Standard Deviation|Mean
2650228|NCT01670292|Secondary|Kinetic Measure - Spinal Segment Load (SSL) Rate of Loading for Force|"SSL* contains variables: rate of loading for force in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C).~*Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal.~Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6."|6 weeks|Note: 82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively, and a total of 593 SM was delivered during visits 1, 5, and 12. The number of observations for individual measures is lower than the total number of analyzable SM (n=575) due to missing data in corresponding components.|||Newton/second|Spinal Manipulations|Standard Deviation|Mean
2650229|NCT01670292|Secondary|Kinetic Measure - Spinal Segment Load (SSL) Moment|"SSL* contains variables: maximum amplitude (Newton*Meter for moment) during preload and peak thrust force in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C).~*Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal.~Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6."|6 weeks|Note: 82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively, and a total of 593 SM was delivered during visits 1, 5, and 12. The number of observations for individual measures is lower than the total number of analyzable SM (n=575) due to missing data in corresponding components.|||Newton*Meter|Spinal Manipulations|Standard Deviation|Mean
2650230|NCT01670292|Secondary|Kinetic Measure - Spinal Segment Load (SSL) Force|"SSL* contains variables: maximum amplitude (Newton) during preload and peak thrust force in anterior-posterior (X), side-to-side (Y), head-to-toe direction (Z) and combined force (C).~*Interpretation: the purpose of the outcomes is to quantify force-time profile of SM. The values of the outcome depend on the doctor who delivers SM, location and direction of SM, participant body position, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, or lower than normal.~Sign convention: because patient position would affect the sign of some measurements, the right side up position was used as the reference position (i.e., the affected measurements assessed in the left side up position had their sign inverted) in order to calculate mean and SD. The value reported is the change from baseline to week 6."|6 weeks|Note: 82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively, and a total of 593 SM was delivered during visits 1, 5, and 12. The number of observations for individual measures is lower than the total number of analyzable SM (n=575) due to missing data in corresponding components.|||Newton (N)|Spinal Manipulations|Standard Deviation|Mean
2650231|NCT01670292|Primary|Flexion-Relaxation Ratio (FRR)|"FRR contains 4 variables, which are the average right and left back muscle FRR obtained using 1) maximum EMG during flexion, and 2) maximum EMG during extension to normalize EMG during full flexion; and asymmetry between the right and left back muscle FRRs using 3) maximum EMG during flexion, and 4) maximum EMG during extension to normalize EMG during full flexion~FRR Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is high than normal, normal, lower than normal."|Baseline, 2 weeks, 6 weeks||||ratio||Standard Deviation|Mean
2650232|NCT01670292|Primary|Lumbar-spine Stiffness (LSS) - Normalized Global Stiffness Variation|"LSS contains 2 variables: Palpatory and Handheld device - normalized global stiffness variation (nGSV, unitless).~LSS Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is higher than normal, normal, lower than normal."|Baseline, 2 weeks, 6 weeks||||unitless||Standard Deviation|Mean
2650233|NCT01670292|Primary|Lumbar-spine Stiffness (LSS)|"LSS* contains 5 variables: global stiffness (GS, unit: Newton/mm) at L3 from 1) hand palpation 2) a hand-held device & 3) an automated indenter device; global stiffness variation (GSV, unit: Newton/mm) between GS from L1 to L5 from 4) hand palpation & 5) a hand-held device.~*LSS Interpretation: The values of the outcome depend on testing procedure, instruction to participants, and equipment. Currently there is no consensus regarding what value is high than normal, normal, lower than normal."|Baseline, 2 weeks, 6 weeks|82, 71 and 68 participants completed at baseline, after 2 weeks and after 6 weeks, respectively. The number of observations at each of the 3 time points for individual measures is equal to or lower than these numbers due to missing data.|||N/mm||Standard Deviation|Mean
2650310|NCT01669798|Secondary|Objective Tumor Response Via RECIST (Response Evaluation Criteria in Solid Tumors) 1.1|Evaluating the percentage of patients who have objective tumor response (complete or partial) based on RECIST 1.1 criteria.|1 year|Responders are those who achieved a partial response (PR). No subjects achieved a complete response (CR).|||percentage of participants||95% Confidence Interval|Number
2650234|NCT01670292|Primary|Patient-Centered Outcome Measurement Mean Change After 6 Weeks (VAS, RMDQ)|"VAS - Visual Analog Scale - Scale: 0-100 mm (anchors: 0 mm = No Pain, 100 mm = Worst Imaginable Pain). VAS Interpretation: A higher score indicates greater pain intensity. In this study, improvement of 30% from the baseline value was considered clinically significant.~RMDQ - Roland Morris disability questionnaire - Scale: 0 (no disability) to 24 (maximum disability). RMDQ Interpretation: Greater levels of disability are reflected by higher scores. In this study, improvement of 30% from the baseline value was considered clinically significant."|Baseline to 6 weeks|82 and 68 participants completed at baseline and after 6 weeks, respectively. Data from all participants (n=82) were used in statistical analysis. The reported data represents the mean change from baseline to week 6.|||units on a scale (see description above)||95% Confidence Interval|Mean
2650235|NCT01670279|Primary|Change From Baseline to Study Completion in C-SSRS Score.|The C-SSRS was one of the primary parameters to measure the safety and tolerability of individual participants. Suicidality was monitored during the trial using the C-SSRS. This scale consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post-baseline evaluation that focuses on suicidality since the last trial visit.|Baseline, End of Titration, Fixed dose Day 14 and 28, Day 15 and 29, Early Termination, Last Visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.|||Participants|||Number
2650236|NCT01670279|Primary|Mean Change From Baseline to Study Completion in Abnormal Involuntary Movement Scale (AIMS) Rating Score.|EPS was one of the primary parameters to measure the safety and tolerability of individual participants. The AIMS Scale was an EPS rating scale. The AIMS is a 12 item scale. The first 10 items are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28.|End of Titration, Day 15, Day 29, Early Termination and Last visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
2650237|NCT01670279|Primary|Mean Change From Baseline to Study Completion in Barnes Akathisia Global Score|EPS was one of the primary parameters to measure the safety and tolerability of individual participants. The Barnes Akathisia Rating Scale was an EPS rating scale. The Barnes Akathisia Rating Scale was used to assess the presence and severity of akathisia. This scale consists of 4 items. Only the 4th item, the Global Clinical Assessment of Akathisia, was evaluated in this trial. This item is rated on a 6 point scale, with 0 being best (absent) and 5 being worst (severe akathisia).|End of Titration, Day 15, Day 29, Early Termination and Last visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
2650238|NCT01670279|Primary|Mean Change From Baseline to Study Completion in Simpson-Angus Scale (SAS) Total Score|EPS was one of the primary parameters to measure the safety and tolerability of individual participants. The SAS is a rating scale used to measure EPS. The SAS scale consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40.|End of Titration, Day 15, Day 29, Early Termination and Last visit|Safety Sample includes all randomized participants who receive at least one dose of study medication.|||Units on a scale||Standard Deviation|Mean
2650239|NCT01670279|Primary|Incidence of Physical Examination Evaluation of Potential Clinical Significance|The physical examination evaluation was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in the following body systems: head, ears, eyes, nose, and throat; thorax; abdomen; urogenital; extremities; neurological; and skin and mucosae.|Physical examination was performed at Screening, check-in, and discharge|Safety Sample was analyzed. Any clinically significant condition present at the post-treatment physical examination that was not present at the baseline examination was documented as an adverse event and followed to a satisfactory conclusion. There were no clinically significant physical examination findings reported in this study.|||Participants|||Number
2650240|NCT01670279|Primary|Incidence of ECG Evaluations of Potential Clinical Significance|The measurement of ECG was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, and QTcF that were identified based on pre-defined criteria.|Titratrion Day 1 and 7, Fixed dose Day 1, 14, 28, Early Termination|The safety dataset included all randomized participants who received at least one dose of study medication.|||Participants|||Number
2650241|NCT01670279|Primary|Incidence of Vital Signs of Potential Clinical Significance|The vital signs were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria.|Baseline, Titration Day 1, 2, 7, 8, Fixed Days 1, 2, 14, 15, 28, 29, Early Termination and Last Visit.|The safety dataset included all randomized participants who received at least one dose of study medication.|||Participants|||Number
2650242|NCT01670279|Primary|Incidence of Laboratory Values of Potential Clinical Significance|The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria.|Titration Day 7, Fixed dose Day 14 and 28 and Last Visit|The safety dataset included all randomized participants who received at least one dose of study medication.|||Participants|||Number
2650243|NCT01670279|Primary|Number of AEs Reported.|The AEs were one of the primary parameters to measure the safety and tolerability of individual participants. The AEs were captured for all participants from the time the ICF was signed until the end of the trial. AEs were measured throughout the 14-day titration and 28-day fixed dose phase until follow-up (30 [±2] days after last dose of study medication).|Throughout the study, up to 119 days|The safety dataset included all randomized participants who received at least one dose of study medication.|||Events|||Number
2657974|NCT01601977|Secondary|Health Related Quality of Life|Severe Respiratory Insufficiency (SRI) questionnaire. Higher scores indicate better quality of life (minimum 0, maximum 100)|6 weeks||||units on a scale||Standard Deviation|Mean
2650244|NCT01670279|Primary|Number of Participants Who Tolerated Brexpiprazole|Safety and tolerability of brexpiprazole was noted to be primary outcome measure. Brexpiprazole was judged to be tolerated if at least 6 out of 8 (75%) of the participants in a test cohort tolerated the dose after 14 days of QD dosing at the end of the fixed dose phase based on the blinded data. Dose toleration was defined as follows: during the course of the trial, the participants did not experience any moderate or severe adverse events (AEs) or potentially clinically relevant changes from Baseline in laboratory values, vital signs, electrocardiogram (ECG) tracings, Columbia-Suicide Severity Rating Scale (C-SSRS), or extrapyramidal symptom (EPS) ratings, which were assessed as possibly related to the study drug, and would have warranted a dose decrease or discontinuation of the study drug. The safety and tolerability of brexpiprazole was defined by parameters: AEs, laboratory values, vital signs, ECG, C-SSRS, or EPS ratings, the results of each of the parameters reported separately.|45 Days|Tolerability assessed in phase 1 trial in healthy participants (18-45 years) with MDD as adjunct therapy to ADTs; the efficacy assessed in phase 3 trials in participants (18-65 years) with MDD as adjunct therapy to ADTs. Thus, safety/tolerability of brexpiprazole in participants (>65 years) with MDD as adjunct therapy to ADTs was not characterized.|||participants|||Number
2650245|NCT01670201|Primary|Percentage of Participants Who Had > 95 % Epithelialization at Day 10||10 days||||percentage of participants|||Number
2650246|NCT01670201|Secondary|Pain at Dressing Changes|"The Medain and Full Range values are presented for all pain scores collected over multiple dressing changes, per participant, over the course of 28 Days.~Adult ( 13 years and older) patient informed about his/her pain from No pain (0) to Most intense pain (100) imaginable, by using the Visual Analogue Scale ( VAS),~Children were using the WONG baker faces, they could chose between, no hurt, hurts Little bit, hurts Little more, hurts even more hurts whole lot hurts worst."|28 days||||units on a scale VAS 0-100||Full Range|Median
2650247|NCT01670188|Primary|Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis|Ultrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter|baseline to 14 days post insertion of PICC line||||Participants|||Count of Participants
2650248|NCT01670110|Primary|Absolute Change in Kidney Volume|MRI will be used to measure kidney volume|baseline to 12 months||||percentage of kidney volume||Standard Deviation|Mean
2650249|NCT01670110|Primary|Absolute Change in Liver Volume|MRI will be used to measure liver volume.|baseline to month 12||||percentage of liver volume||Standard Deviation|Mean
2650250|NCT01670045|Secondary|Percentage of Participants With Tocilizumab Dose Modifications||Baseline up to Month 6|ITT.|||percentage of participants|||Number
2650251|NCT01670045|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6|Physician's global assessment of disease activity over the previous 24 hours was assessed using a VAS where left end of the line 0 mm=no disease activity to right end of the line 100 mm=maximum disease activity.|Baseline, Months 3, 6|"ITT. Here number of participants analyzed included evaluable participants for the outcome measure and n included evaluable participants at specified time point."|||mm||Standard Deviation|Mean
2650252|NCT01670045|Secondary|Number of Participants With Reduction/Withdrawal of Disease-modifying Anti-rheumatic Drugs (DMARDs) and/or Corticosteroids|Participants with reduction/withdrawal of DMARDs and corticosteroids at baseline (before trial period) and up to Month 6 (during trial period) were reported.|Baseline, up to Month 6|ITT.|||participants|||Number
2650253|NCT01670045|Secondary|Percentage of Participants Achieving a Response According to ACR Criteria|ACR20/50/70 percent (%) response is defined as a ≥ 20%/50%/70% improvement (reduction) compared with baseline for both TJC28 and SJC28, as well as for three of the additional five ACR core set variables: Participant's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 cm=no pain to right end of the line 10 cm=unbearable pain; Patient's global assessment of disease activity and physician's global assessment of disease activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; health assessment questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or erythrocyte sedimentation rate].|Month 1, 2, 3, 4, 5, 6|ITT.|||percentage of participants|||Number
2650254|NCT01670045|Secondary|Number of Participants With Different Types of Clinical Disease Activity Index (CDAI)|The CDAI was calculated as [SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments: 0 cm =no disease activity to 100 cm=maximum disease activity'. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. CDAI score ≤ 2.8 is 'remission', score > 2.8 and ≤ 10 is 'low disease activity', score > 10 and ≤ 22 is 'moderate disease activity', score > 22 is 'high disease activity'. CDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.|Baseline up to Month 6|ITT.|||participants|||Number
2650255|NCT01670045|Secondary|Number of Participants With Different Types of Simplified Disease Activity Index (SDAI)|The SDAI was calculated as [SJC (28 joints) + TJC (28 joints) + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity+CRP level(milligram/deciliter {mg/dL})]. VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity'. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. SDAI score ≤ 3.3 is 'remission', score > 3.3 and ≤ 11 is 'low disease activity', score > 11 and ≤ 26 is 'moderate disease activity', score > 26 is 'high disease activity'. SDAI was reported as 'not available' for participants with no data on physical/patient global assessment of disease activity.|Baseline up to Month 6|ITT.|||participants|||Number
2650275|NCT01669902|Secondary|Physician Global Assessment (PGA) of Disease Activity|Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.|Baseline, Month 3, Month 6|The FAS (VAS disease activity [physician] included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS disease activity (physician). n = participants evaluable for this measure at specified timepoint.|||mm||Standard Deviation|Mean
2650750|NCT01666314|Secondary|Absolute Values for Testosterone|Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.|Baseline, Cycle 1 Day 8 and Cycle 2 Day 1|Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.|||ng/dL||Standard Deviation|Mean
2650256|NCT01670045|Secondary|Number of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 improvement from Baseline. Participants with a score less than or equal to (≤) 3.2 and DAS28 improvement of greater than (>) 1.2 points were assessed as having a 'good' response. Participants with a score ≤3.2 and DAS28 improvement of >0.6 to ≤1.2 points, score of >3.2 and ≤5.1 with DAS28 improvement of >0.6 to ≤1.2 points, score of >3.2 and ≤5.1 with DAS28 improvement of >1.2 points, score of >5.1 and DAS28 improvement of >1.2 points were assessed as having a 'moderate' response. Participants with a score ≤3.2 and DAS28 improvement of ≤ 0.6 points, score of >3.2 and ≤5.1 with DAS28 improvement of ≤ 0.6 points, score of >5.1 and DAS28 improvement of >0.6 to ≤1.2 points, score of >5.1 and DAS28 improvement of ≤ 0.6 points were assessed as having a 'no' response.|Baseline up to Month 6|ITT.|||participants|||Number
2650257|NCT01670045|Secondary|Percentage of Participants With a Reduction of at Least 2.6 Units in DAS28 From Baseline|The DAS28 score is a measure of the participants' disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment (PtGA) of disease activity [visual analog scale (VAS): 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 was calculated using following formulas: DAS28-ESR = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PtGA of disease activity. A total possible score of 0 to approximately 10, with higher score indicating worse disease activity. A reduction of at least 2.6 units from Baseline in DAS28 was considered as significant clinical improvement.|Baseline, Month 1, 2, 3, 4, 5, 6|ITT.|||percentage of participants|||Number
2650258|NCT01670045|Secondary|Percentage of Participants With Anti-Citrullinated Cyclic Peptide (Anti-CCP) Status|"Percentage of participants with anti-CCP status were reported as positive, negative and unknown."|Baseline up to Day 5|ITT.|||percentage of participants|||Number
2650259|NCT01670045|Secondary|Percentage of Participants With Rheumatoid Factor Status|"Percentage of participants with rheumatoid factor status was reported as positive or negative."|Baseline up to Day 5|ITT.|||percentage of participants|||Number
2650260|NCT01670045|Secondary|Percentage of Participants With Different Body Mass Index (BMI)|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). BMI from 16 to 18.5 = underweight, BMI from 18.5 to 25= normal weight, BMI from 25 to 30= overweight, BMI from 30 to 40 = obese.|Baseline up to Day 5|ITT.|||percentage of participants|||Number
2650261|NCT01670045|Secondary|Percentage of Participants With RA Diagnosis|"Percentage of participants was reported based on the timing RA was diagnosed. Timings included more than 5 years, less than 5 years. Participants with unknown timing were reported under unknown."|Baseline up to Day 5|ITT.|||percentage of participants|||Number
2650262|NCT01670045|Primary|Percentage of Participants Who Remained on Tocilizumab Treatment at 6 Months After Treatment Initiation||Month 6|ITT.|||percentage of participants|||Number
2650263|NCT01670019|Secondary|Rates of Sustained Remission|"Sustained remission will be defined as at least two consecutive post-randomization assessments (weeks 2, 4, and 6) during which minimal depressive psychopathology (MADRS < 7) is present.~MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|2, 4, 6 weeks|Participants that completed all data collection timepoints at week 2, 4, 6.|||participants|||Number
2650264|NCT01670019|Secondary|Clinical Remission Rate|"Clinical Remission will be defined as the number of participants with a MADRS total score < 7.~MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|6 weeks||||participants|||Number
2650265|NCT01670019|Secondary|Clinical Response Rate|"Clinical Response rate will be defined as the number of participants with a > 50% reduction from baseline in MADRS total score.~MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|Baseline, 6 weeks||||participants|||Number
2650266|NCT01670019|Secondary|Study Completion Rate|The percentage of patients completing the study in their assigned treatment arm (asenapine or placebo) at the end of 6 weeks|6 weeks||||percentage of participants|||Number
2650267|NCT01670019|Primary|Change in MADRS Total Score|"The Montgomery Asberg Depression Rating Scale (MADRS) is used by clinicians to assess the severity of depression among patients with a diagnosis of depression. It is designed to be sensitive to change resulting from antidepressant therapy.~MADRS is a 10-item scale. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms."|Baseline, 6 weeks|Analysis includes those participants who completed week 6 assessment.|||units on a scale||Standard Deviation|Mean
2650268|NCT01669902|Secondary|Number of Participants With Use of Disease-Modifying Anti-Rheumatic Drugs (DMARDs) During the Study||Baseline to Month 6|Safety Analysis Set|||participants|||Number
2650269|NCT01669902|Secondary|Percentage of Participants With Concomitant Corticosteroids Treatment||Baseline to Month 6|Safety Analysis Set|||percentage of participants|||Number
2650270|NCT01669902|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 3 and Month 6|The FAS (HAQ) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for HAQ.|||units on a scale||Standard Deviation|Mean
2650271|NCT01669902|Secondary|Percentage of Participants With Duration of Morning Stiffness|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. Duration was recorded as less than (<) 30 minutes, 30 to 60 minutes, 60 to 120 minutes, 120 to 240 minutes, more than (>) 240 minutes, or whole day.|Baseline, Month 3, Month 6|FAS (morning stiffness). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.|||percentage of participants|||Number
2650277|NCT01669902|Secondary|Number of Participants With an American College of Rheumatology (ACR) Response|ACR response: improvement in tender or swollen joint counts and improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) patient's assessment of pain, 4) patient's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. ACR response is based on 66/68 total joint count.|Baseline to Month 6|Data for ACR response was not reported because in clinical practice the 66/68 joint evaluation needed for this is not performed in the Sweden, Denmark and Norway, the 28 joint count is performed instead.||||||
2650278|NCT01669902|Secondary|Percentage of Participants Achieving Clinical Remission Based on CDAI|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Month 3 and Month 6|FAS (CDAI). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.|||percentage of participants|||Number
2650279|NCT01669902|Secondary|Clinical Disease Activity Index (CDAI)|The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Baseline, Month 3, Month 6|The FAS (CDAI) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for CDAI. n = participants evaluable for this measure at specified timepoint.|||Units on a scale||Standard Deviation|Mean
2650280|NCT01669902|Secondary|Percentage of Participants Achieving Clinical Remission Based on SDAI|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Month 3 and Month 6|FAS (SDAI). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.|||percentage of participants|||Number
2650281|NCT01669902|Secondary|Simplified Disease Activity Index (SDAI)|The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and physician global assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Baseline, Month 3, Month 6|The FAS (SDAI) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for SDAI. n = participants evaluable for this measure at specified timepoint.|||Units on a scale||Standard Deviation|Mean
2650282|NCT01669902|Secondary|Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)|The DAS28-4 (ESR) [described in Outcome Measure 7] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline >1.2 with DAS28 <= 3.2; moderate responders: change from baseline >1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline >1.2 with DAS28 >5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 <=3.2; non-responders: change from baseline <= 0.6 or change from baseline in the range of >0.6 to <=1.2 with DAS28 >5.1 or change from baseline <=0.6 with DAS28 <=3.2 or in the range of >3.2 to <=5.1.|Month 3 and Month 6|FAS (DAS28-4 [ESR]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.|||percentage of participants|||Number
2650283|NCT01669902|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)|The DAS28-4 (CRP) [described in Outcome Measure 5] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline >1.2 with DAS28 <= 3.2; moderate responders: change from baseline >1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 in the range of >3.2 to <=5.1 or change from baseline >1.2 with DAS28 >5.1 or change from baseline in the range of >0.6 to <=1.2 with DAS28 <=3.2; non-responders: change from baseline <= 0.6 or change from baseline in the range of >0.6 to <=1.2 with DAS28 >5.1 or change from baseline <=0.6 with DAS28 <=3.2 or in the range of >3.2 to <=5.1.|Month 3 and Month 6|FAS (DAS28-4 [CRP]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.|||percentage of participants|||Number
2650284|NCT01669902|Secondary|Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (ESR)|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = clinical remission.|Month 3 and Month 6|FAS (DAS28-4 [ESR]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.|||percentage of participants|||Number
2650296|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Difficulty of Swallowing at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -difficulty of swallowing at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -difficulty of swallowing at baseline were included.|||Percentage of participants|||Number
2650285|NCT01669902|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter per hour [mm/hour]), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = clinical remission.|Baseline, Month 3, Month 6|The FAS (DAS28-4 [ESR]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for DAS28-4 [ESR] assessment. n = participants evaluable for this measure at specified timepoint.|||Units on a scale||Standard Deviation|Mean
2650286|NCT01669902|Secondary|Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP)|DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (mg/L) and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) < 2.6 = clinical remission.|Month 3 and Month 6|FAS (DAS28-4 [CRP]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.|||percentage of participants|||Number
2650287|NCT01669902|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])|DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (milligram per liter [mg/L]) and patient global assessment (PtGA) of disease activity (measured on a 0 to 100 millimeter [mm] Visual Analog Scale [VAS]) where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) less than or equal to (<= 3.2) implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) less than (<) 2.6 = clinical remission.|Baseline, Month 3, Month 6|The FAS (DAS28-4 [CRP]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for DAS28-4 [CRP] assessment. n = participants evaluable for this measure at specified timepoint.|||Units on a scale||Standard Deviation|Mean
2650288|NCT01669902|Secondary|Tender Joint Count (TJC)|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of tender joints compared to baseline indicates improvement.|Baseline, Month 3, Month 6|The FAS (tender joint counts) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for tender joints. n = participants evaluable for this measure at specified timepoint.|||tender joint count||Standard Deviation|Mean
2650289|NCT01669902|Secondary|Swollen Joint Count (SJC)|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of swollen joints compared to baseline indicates improvement.|Baseline, Month 3, Month 6|The Full Analysis Set (FAS) (swollen joint counts) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for swollen joints. n = participants evaluable for this measure at specified timepoint.|||swollen joint count||Standard Deviation|Mean
2650290|NCT01669902|Secondary|Percentage of Participants With Dose Modifications of Tocilizumab|Dose modification is any change in dose; this also included participants who stopped treatment with tocilizumab.|Baseline to Month 6|Safety Analysis Set|||percentage of participants|||Number
2650291|NCT01669902|Primary|Percentage of Participants on Tocilizumab Treatment at Month 6||Month 6|Safety Analysis Set|||percentage of participants|||Number
2650292|NCT01669863|Other Pre-specified|Change in Oxygenation Index During Application of ECMO|Oxygenation index (PaO2/FiO2) will be monitored regularly during the ICU stay|Duration of ICU stay|Data for this outcome were not collected. We intended to measure the PaO2/FiO2 ratio in all patients anticipating that all patients would be mechanically ventilated, either invasively or non-invasively. However, it turned out that most patients did not require mechanical ventilation while on ECMO.||||||
2650293|NCT01669863|Secondary|Number of Participants Who Presented With ECMO-Related Complications|ECMO-related complications|Duration of ICU stay||||participants|||Number
2650294|NCT01669863|Primary|Number of Participants That Did Not Require Endotrachael Intubation|- N=6 patients will be enrolled in this exploratory pilot trial; if endotracheal intubation can be avoided in 2 or more of these patients, the trial will be considered positive. In that case, the next step would be a larger trial to better define the patient population with the highest likelihood of responding to this new therapeutic concept.|Duration of ICU stay||||participants|||Number
2650295|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Sleep Disturbance at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -sleep disturbance at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -sleep disturbance at baseline were included.|||Percentage of participants|||Number
2650309|NCT01669798|Secondary|Duration of Progression-Free Survival|The duration of progression-free survival and overall survival measured in months; Progression-Free Survival (PFS) is defined as the duration of time from study entry to time of progression or death, whichever occurs first.|Through study completion, on average 2 years|Analysis stratified results between PFS (Progression Free Survival) and OS (Overall Survival). Confidence interval and results based on Kaplan Meier Estimates.|||Months||95% Confidence Interval|Median
2650297|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Abdominal Pain at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -abdominal pain at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -abdominal pain at baseline were included.|||Percentage of participants|||Number
2650298|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Acid Regurgitation at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -acid regurgitation at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -acid regurgitation at baseline were included.|||Percentage of participants|||Number
2650299|NCT01669811|Secondary|Cumulative Percentage of Participants Who Had Sustained Resolution of GERD Symptom -Heartburn at Week 4|Cumulative percentage of participants who had sustained resolution (defined as at least 7-day consecutive symptom free) of gastroesophageal reflux disease (GERD) symptom -heartburn at Week 4 (on Day 29) based on the Kaplan-Meier method.|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who took at least one dose of investigational product. However, out of these participants, only participants who had the GERD symptom -heartburn at baseline were included.|||Percentage of participants|||Number
2650300|NCT01669811|Secondary|"Percentage of Participants With Healing of RE Who Were Graded O at Week 4 Out of Participants Who Were Graded A to D at Baseline According to Los Angeles Classification"|"Percentage of participants with healing of reflux esophagitis (RE) who were graded O (No RE) at Week 4 out of participants who were graded A (least severe) to D (most severe) at baseline according to Los Angeles classification"|4 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who had at least one dose of investigational product|||Percentage of participants||95% Confidence Interval|Number
2650301|NCT01669811|Primary|"Percentage of Participants With Healing of RE Who Were Graded O at Week 8 Out of Participants Who Were Graded A to D at Baseline According to Los Angeles Classification"|"Percentage of participants with healing of reflux esophagitis (RE) who were graded O (No RE) at Week 8 out of participants who were graded A (least severe) to D (most severe) at baseline according to Los Angeles classification"|8 Weeks|Included all of the randomised participants who were definitely diagnosed to have refractory RE before the randomisation and who had at least one dose of investigational product|||Percentage of participants||95% Confidence Interval|Number
2650302|NCT01669798|Other Pre-specified|Concentration of VCAM-1 Reported as a Function of Treatment Response|Correlating baseline and on treatment levels of VCAM-1 measured in micrograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment|1 year|Biomarker levels measured and stratified into two groups: those who experienced either Partial Response (PR) or Stable Disease (SD); and those who experienced Progressive Disease (PD). Data was not collected for one subject.|||micrograms per milliliter||Inter-Quartile Range|Median
2650303|NCT01669798|Other Pre-specified|Concentration of Select Growth Factors Measured in Nanograms Per Milliliter Reported as a Function of Treatment Response|Correlating baseline and on treatment levels of additional growth factors measured in nanograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment|1 year|Biomarker levels measured and stratified into two groups: those who experienced either Partial Response (PR) or Stable Disease (SD); and those who experienced Progressive Disease (PD). Data was not collected for one subject.|||nanograms per milliliter||Inter-Quartile Range|Median
2650304|NCT01669798|Other Pre-specified|VEGF Levels Correlated With Treatment Outcome|"Baseline levels of VEGF were correlated with treatment outcome. Results are stratified in groups: Partial Response (PR) or Stable Disease (SD) and Progressive Disease (PD)"|1 year|VEGF levels measured and stratified into two groups: those who experienced either Partial Response (PR) or Stable Disease (SD); and those who experienced Progressive Disease (PD). Data was not collected for one subject|||picograms per milliliter||Inter-Quartile Range|Median
2650305|NCT01669798|Other Pre-specified|Coagulation and Endothelial Cell Activation Markers|To measure baseline and on treatment levels of additional growth factors that may be co- or counter- regulated with VEGF and correlate with response to treatment.|1 year|We initially planned to measure baseline and on treatment levels of coagulation and endothelial cell activation markers that may predict for thrombotic or bleeding risks related to treatment. These markers are best analyzed in citrated plasma and funding was not available for tube collection and analysis.||||||
2650306|NCT01669798|Other Pre-specified|Concentration of Select Growth Factors Reported Measured in Picograms Per Milliliter as a Function of Treatment Response|Correlating baseline and on treatment levels of additional growth factors measured in picograms per milliliter that may be co- or counter- regulated with VEGF with response to treatment|1 year|Biomarker levels measured and stratified into two groups: those who experienced either Partial Response (PR) or Stable Disease (SD); and those who experienced Progressive Disease (PD). Data was not collected for one subject.|||picograms per milliliter||Inter-Quartile Range|Median
2650307|NCT01669798|Secondary|Adverse Event Frequency and Severity|To determine frequency and severity of adverse events as assessed using NCI Common Toxicity Criteria version 4.|1 year|All adverse events considered possible, probably, or definitely related to study drug. Reported regardless of severity.|||Participants|||Count of Participants
2650308|NCT01669798|Secondary|Objective Tumor Response Based on GCIG CA-125 Criteria|"The proportion of patients who have objective tumor response (complete or partial) based on Gynaecologic Cancer InterGroup(GCIG) CA-125 criteria which is: A response according to CA 125 has occurred if there is at least a 50% reduction in CA 125 levels from a pretreatment sample. The response must be confirmed and maintained for at least 28 days.."|1 year|Twenty five subjects were analyzed based on the Gynaecologic Cancer Intergroup response CA125 response criteria. Two subjects data were unavailable.|||Participants|||Count of Participants
2650311|NCT01669798|Primary|Percentage of Patients Who Survive Progression-free|Measure of Progression Free Survival (PFS) by the percentage of patients who survive progression-free for at least 6 months after initiating study therapy in patients with bevacizumab-resistant, persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.|6 months|The analysis was to be based on 27 evaluable patients for the first stage. Subjects were considered evaluable if they completed at least one cycle of study drug. Of the 27 subjects, one was not considered evaluable because they did not receive a full cycle.|||percentage of participants||95% Confidence Interval|Number
2650312|NCT01669785|Secondary|Long-term Sensitivity Relief (Self-Assessment)|"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity 28 days following prophylaxis treatment.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity;1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|28 days post-prophylaxis treatment.||||units on a scale||Standard Deviation|Mean
2650313|NCT01669785|Secondary|Post-prophylaxis Sensitivity Relief (Self-Assessment)|"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity immediately following the timed, 1-minute prophylaxis paste application.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth;2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Immediately following post-prophylaxis treatment.||||units on a scale||Standard Deviation|Mean
2650314|NCT01669785|Secondary|Post- Scaling Sensitivity Relief (Self-Assessment)|"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity immediately following the scaling procedure.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Post-scaling procedure,immediate||||units on a scale||Standard Deviation|Mean
2650315|NCT01669785|Primary|Long-term Sensitivity Relief (Schiff Air Blast Sensitivity)|"Assessment of sensitivity score Schiff air blast measurements long term after treatment.~Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:~0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|28 days (+/- 2 days) post treatment.||||units on a scale||Standard Deviation|Mean
2650316|NCT01669785|Primary|Immediate Sensitivity Relief (Schiff Air Blast Sensitivity)|"Assessment of sensitivity score via air blast measurements immediately after treatment.~Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivity scale (0-3). The scale is scored as follows:~0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Immediately after treatment .||||units on a scale||Standard Deviation|Mean
2650317|NCT01669785|Primary|Baseline Pre-Prophy Assessment (Air Blast Sensitivity)|"Pre-prophy procedure baseline assessment using Schiff Cold Air Sensitivity scale (0-3).~Air blast hypersensitivity is measured using the Schiff Cold Air Sensitivty scale (0-3). The scale is scored as follows:~0=Subject does not respond to stimulus; 1= Subject responds to stimulus but does not request discontinuation of stimulus; 2=Subject responds to stimulus and requests discontinuation or moves from air stimulus; 3=Subject responds to stimulus, considers it painful and requests discontinuation.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Pre-treatment measurement||||units on a scale||Standard Deviation|Mean
2650318|NCT01669785|Secondary|Sensitivity Relief (Self-Assessment)|"All subjects completed a questionnaire titled How sensitive are your teeth? to assess their whole-mouth tooth sensitivity prior to the baseline assessments.~The questionnaire contained a 4-item verbal descriptor scale as follows:~Score 0= no discomfort or awareness of sensitivity; 1=mild discomfort/pain from sensitive teeth; 2=moderate discomfort/pain from sensitive teeth; 3=severe pain from sensitive teeth.~The higher the score, the higher the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Pre-Treatment||||units on a scale||Standard Deviation|Mean
2650319|NCT01669785|Primary|Long-term Sensitivity Relief (Tactile Sensitivity)|"Assessment of sensitivity score via tactile measurements long term after treatment.~Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10 to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|28 days (+/- 2 days) post treatment.||||grams||Standard Deviation|Mean
2650320|NCT01669785|Primary|Immediate Sensitivity Relief (Tactile Sensitivity)|"Assessment of sensitivity score via tactile and air blast measurements immediately after treatment. Tactile hypersensitivity is measured with an electronic force sensing probel (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10, 20, 30, 40 up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitivity.~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Immediately after treatment .||||grams||Standard Deviation|Mean
2650321|NCT01669785|Primary|Baseline Pre-Prophy Assessment (Tactile Sensitivity)|"Pre-prophy procedure baseline assessment is measured with an electronic force sensing probe (Yeaple probe). Grams of force needed to elicit pain are recorded as hypersensitivity score for the tooth. 10,20,30,40, up to 50 grams of force are applied to the hypersensitive tooth until pain is elicited. The higher the score (the more grams of force needed to elicit a response of pain), the lower the hypersensitiv~Subjects were required to have two sensitive teeth which are not adjacent to each other and preferably in different quadrants. Scores were obtained by taking the average over the scores for the evaluated teeth."|Pre-treatment measurement||||grams||Standard Deviation|Mean
2650322|NCT01669720|Secondary|Number of Participants Who Experienced a Toxicity Profile of Adjuvant Ziv-aflibercept, up to 2-years of Duration, for Patients Who Previously Received Systemic Perioperative Therapy (Regimen) and Surgical Resection/Ablation.|Toxicity defined by CTCAE Version 4.0 toxicities|Throughout study treatment until 30 days post off study, approximately 2 years|Data table reflects total number of patients who experienced a toxicity on study.|||Participants|||Count of Participants
2650323|NCT01669720|Primary|Number of Patients Who Progressed|Disease free survival in patients with advanced colorectal cancer who have undergone resection/ablation of all metastatic sites.|Every 3 months until disease progression (for up to 2 years).||||participants|||Number
2650324|NCT01669642|Other Pre-specified|Total Sedation Time|during recovery, all participants are monitored for recovery to baseline at which point participants are ready for discharge. we will document the time from induction to recovery to aldrete score of 10.|Time of administration of ketamine through sedation recovery||||minutes||Full Range|Median
2650325|NCT01669642|Secondary|Number of Participants With Wisconsin Sedation Scale Score of 2 or Less at 1 Minute After First Dose of Ketamine|"This is a measure of sedation effectiveness; to assess the effectiveness of first dose of ketamine administered.~Possible values for the scale range from 0 to 6. A sedation score of 2 or less is considered adequate sedation. Values more than 2 indicate state of inadequate sedation. higher values indicate the need for additional doses of sedation.~Patients who achieved a score of 2 or less are considered effective sedation and a score of >2 are considered ineffective sedations."|Dose administration through 1 minute||||participants|||Number
2650326|NCT01669642|Secondary|Vomiting|patients who experienced vomiting while in the ED or after discharge|Administration of ketamine through 2 week follow up call||||Participants|||Count of Participants
2650327|NCT01669642|Primary|ED95|ED95 is the dose of ketamine effective for 95% of children. this outcome is estimated from ED50.|Dose administration through 5 minutes||||mg/kg of ketamine dose|||Number
2650328|NCT01669642|Primary|Median Effective Dose (ED50) and ED95 of Rapidly Administered Ketamine|ED50 is the dose of rapidly administered ketamine that achieves effective sedation in 50% of patients. ED95 is the dose of ketamine that can provide effective sedation in 95% of children undergoing abscess drainage or fracture reduction. ED95 will be calculated for the 3 age groups (2-5, 6-11 and 12-17) independently for both the procedures: abscess drainage and fracture reduction.|Dose administration through 5 minutes|100 children were enrolled in 5 different groups depending on the age and type of procedure.|||mg/kg of ketamine dose||Full Range|Median
2650329|NCT01669629|Secondary|Overall Corneal Staining|"Proportion of subjects that have corneal staining on the 0-4 the NEI/Industry Workshop guidelines scale, measured by eye.~Grade 1 or higher is reported as a percentage of total eyes."|6-10 Days|Subjects are those who were enrolled, randomized, and completed the study per protocol. Percentage of eyes.|||percentage of eyes|eyes||Number
2650330|NCT01669629|Secondary|Binocular Snellen Visual Acuity|Snellen visual acuity percentage of eyes with a visual acuity of eyesight testing at a 20/20 level or better by eye.|6-10 Days|Subjects are those who were enrolled, randomized, and completed the study per protocol. Number of subjects is total in sample due to stratification by device and binocular measurement setting only.|||percentage of eyes|Eyes||Number
2650331|NCT01669629|Secondary|Subject Reported Overall Vision|Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using an aggregate summary of excellent/very good at their 1-week visit.|6-10 Days||||percentage of participants|||Number
2650332|NCT01669629|Secondary|Subject Reported Overall Comfort|Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Summary is reported as an aggregate of Excellent/Very Good at their 1-week visit.|6-10 Days||||percentage of participants|||Number
2650333|NCT01669629|Primary|Subject Reported Ease of Removal|Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit.|6-10 Days|Subjects analyzed were those who enrolled, randomized, and completed the study per protocol.|||percentage of participants|||Number
2650334|NCT01669603|Primary|Interleukin-8 (IL-8)|Nasal lavage will be performed to collect and measure IL-8.|72 hours|analysis cohort was those volunteers who were susceptible to RV-A39 by neutralizing antibody titer, had no virus detected in the nasal lavage on day 0, and who were infected and completed the study|||pg/ml||Standard Deviation|Geometric Mean
2650335|NCT01669577|Primary|Death|30 days after trauma mortality evaluation|Within the first 30 days|severe polytrauma patients (ISS>15)|||participants|||Number
2650366|NCT01669096|Primary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Day 0 to Month 7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2650336|NCT01669538|Secondary|Common Side Effects of Galantamine Check List|"Subjects completed a side effect checklist at every in-person study visit over the course of the treatment period. Subjects rated the severity of 37 common side effects of galantamine on the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The average of all items was used to create a summary side effect score (range for total summary score 0-3). Higher scores indicate greater severity of side effects.~Side effects of galantamine were assessed at the following in-person sessions: Baseline session; Day 7 (brief monitoring visit); Day 14 (Day before 24-hour abstinence period), Day 16 (after 24-hour abstinence period), and Days 17-23 (during the 7-day quit attempt)."|Baseline (day 0), Days 7, 14, 16, 17, 19, 21, and 23|Number of subjects who completed the study in each arm|||units on a scale||Standard Deviation|Mean
2650337|NCT01669538|Secondary|Subjective Symptoms|"Smoking urges [Questionnaire of Smoking Urges-Brief; QSU-B; 10-items rated on a 7-point scale (1=strongly disagree, 7=strongly agree) and summed for total score (range: 10-70). Higher scores=greater urge to smoke.] Negative mood [Negative Affect scale (10 items) from the Positive and Negative Affect Schedule; PANAS; 20-item Likert-format measure; The subscale was summed to create a summary score (range: 10-50); Lower negative affect indicates better outcomes.] Nicotine withdrawal [Minnesota Nicotine Withdrawal Scale-Revised; MNWS-R; 15 symptoms are rated on intensity with the following scale: 0=none, 1=slight, 2=mild, 3=moderate, 4=severe. The first 9 items are summed for total score (range: 0-36); higher scores=more severe withdrawal.].~Measures assessed at the following visits: Baseline; Day 7 (monitoring visit); Day 14 (Day before 24-hour abstinence period), Day 16 (after 24-hour abstinence period), and Days 17-23 (7-day quit attempt)."|Baseline (day 0), Days 7, 14, 16, 17, 19, 21, and 23|Number of subjects who completed the study in each arm|||units on a scale||Standard Deviation|Mean
2650338|NCT01669538|Secondary|Cognitive Performance|Participants will complete neurocognitive tests designed to test working memory and attention. These tests are similar to computer games, in that participants will push a button in response to the pictures they see.|Baseline (Day 0), Day 14 (day before start of 24-hour abstinence period), Day 16 (after 24-hour abstinence period ends)|Number of subjects who completed the study in each arm|||number of correct responses||Standard Deviation|Mean
2650339|NCT01669538|Primary|Total Number of Smoke-free Days (Biochemically Verified) During a 7-day Quit Attempt.|Day 17 will be the beginning of a 7-day quit attempt, during which the total number of days of abstinence will be assessed.|Days 17-23|Number of subjects who completed the study in each arm|||days||Standard Deviation|Mean
2650340|NCT01669434|Secondary|Postoperative Hypotension|Any systolic blood pressure less than 90 mmHg|Arrival in PACU to hospital discharge, an expected average of 4 days.||||Participants|||Count of Participants
2650341|NCT01669434|Secondary|Postoperative Hypertension|Any systolic blood pressure greater than 180 mmHg.|Arrival in PACU to hospital discharge, an expected average of 4 days.||||Participants|||Count of Participants
2650342|NCT01669434|Secondary|Older Age Subgroup|Only patients above the age of 64 will be included in this analysis. The outcome is the same as the primary outcome: Intraoperative Systolic Blood Pressure under 80 mmHg|During anesthesia, an expected average of 3 hours.||||Participants|||Count of Participants
2650343|NCT01669434|Secondary|Low Blood Pressure Subgroup|Only patients with systolic blood pressure less than 110 at preoperative evaluation will be included in this analysis. The outcome is the same as the primary outcome: Intraoperative Systolic Blood Pressure under 80 mmHg.|During anesthesia, an expected average of 3 hours.||||Participants|||Count of Participants
2650344|NCT01669434|Secondary|Acute Renal Failure|Creatinine increase of more than 0.3 mg/dl or more than 50% from preoperative level|Arrival in post-anesthesia care unit (PACU) to hospital discharge, an expected average of 4 days.|Missing outcome data for 37 patients, 18 in the ACEI omission arm and 19 in the ACEI continuation arm|||Participants|||Count of Participants
2650345|NCT01669434|Primary|Number of Participants With Interoperative Hypotension|Systolic Blood Pressure under 80 mmHg|During anesthesia, an expected average of 3 hours.||||Participants|||Count of Participants
2650346|NCT01669421|Other Pre-specified|Elastin Degradation in BAL|Desmosine/isodesmosine measured using mass spectometry.|Week 4 vs Week 8 vs Week 12||||ng/ml||Standard Deviation|Mean
2650347|NCT01669421|Secondary|Number of Adverse Events Reported||From Week 1 to week 12||||Events|||Number
2650348|NCT01669421|Secondary|Change in Inflammatory Biomarkers in Serum Samples|Assess the variations in the levels of cytokines and inflammatory biomarkers using the bead technology.|Between baseline (week 4), double dose A1PI (week 8) and again standard dose (week 12)||||pg/ml||Standard Deviation|Mean
2650349|NCT01669421|Primary|Changes in Inflammatory Biomarkers in Bronchoalveolar Lavage Fluid|"Assess the variations in the levels of several cytokines and inflammatory biomarkers in BAL after changing A1PI dosing.~Measures were done using the bead technology."|Between baseline (week 4), double dose A1PI (week 8) and again standard dose (week 12)|Subjects with AATD and COPD that require augmentation therapy|||pg/ml||Standard Deviation|Mean
2650350|NCT01669174|Secondary|AUC0-56 and AUClast|AUC0-56, the area under the serum concentration-time curve from the time zero to the end of the dosing interval, day 56. AUC0-56 was analyzed for dose 1 and 2. AUClast is from time zero to the last quantifiable concentration. AUClast was analyzed for dose 2 only.|0 hour, 2 hour, Day 8, 15, 29, 57, 71, 85, 99, 113, 127, 168 post dose|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.|||day*ug/mL||Standard Deviation|Mean
2650351|NCT01669174|Secondary|Time to Reach the Maximum Concentration After Drug Administration (Tmax)|The time to reach the maximum concentration after drug administration|24 weeks|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.|||hr||Full Range|Median
2650352|NCT01669174|Secondary|Maximum Observed Serum Concentration (Cmax)|The observed maximum plasma concentration following drug administration|0 hour, 2 hour, Day 8, 15, 29, 57, 71, 85, 99, 113, 127, 168 post dose|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.|||ug/mL||Standard Deviation|Mean
2650353|NCT01669174|Secondary|Change in 6 Minute Walk Distance Compared to Placebo|Practical simple test that requires a 100-ft hallway but no exercise quipment or advanced training for technicians. Walking is an activity performed daily by all but the most severely impaired patients. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD)|Baseline, Weeks 4, 8, 16, 24|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame|||meter||Standard Deviation|Mean
2650354|NCT01669174|Primary|Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 4, 8, 16, and 24|Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was no more than or equal to 2% at Week 4,8,16 and 24 was considered responders.|Baseline, Weeks 4, 8, 16, 24|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame.|||Percentage Change of TMV||Standard Deviation|Mean
2650355|NCT01669148|Primary|Detection of Breast Cancer (Sensitivity)|"Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN):~Sensitivity = TP / (TP+FN)"|up to two years follow up for development of breast cancer|PI left institution in 2012; Data remaining did not include outcome measure and adverse event data. Institution contacted PI on numerous occasions. PI also does not have data.||||||
2650356|NCT01669122|Secondary|Plasma Half Life (t1/2)|Half-life of elimination of nicotine was determined. t1/2 was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.|||hours||Standard Deviation|Mean
2650357|NCT01669122|Secondary|Rate of Elimination (Kel)|Elimination rate constant for nicotine was calculated. Kel was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.|||1/ hour||Standard Deviation|Mean
2650358|NCT01669122|Secondary|Time to Maximum Plasma Concentration (Tmax)|Tmax was determined from plasma concentration time profiles. Tmax was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.|||hours||Full Range|Median
2650359|NCT01669122|Secondary|AUC(0-inf)|Area under the plasma nicotine concentration-time curve from zero extrapolated to infinity was determined. AUC(0-inf) was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.|||ng*hr/mL||Standard Deviation|Mean
2650360|NCT01669122|Primary|Maximum Plasma Concentration (Cmax)|Maximum plasma nicotine concentration was determined from plasma-concentration time profiles. Cmax was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|PP population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.|||ng/mL||Standard Deviation|Mean
2650361|NCT01669122|Primary|Area Under the Curve From Time 0 to t, AUC (0-t)|Area under the plasma concentration time curve from zero and extrapolated to the time of last quantifiable sample was determined from plasma concentration time profile of nicotine. AUC(0 -t) was based on the baseline adjusted nicotine plasma concentration data.|Blood samples were collected pre-dose and at 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours post dosing|Per protocol (PP) population: all randomized participants profiles, without a protocol deviation that would have lead to the data exclusion.|||nanograms (ng)*hours (h)/milliliter (mL)||Standard Deviation|Mean
2650362|NCT01669096|Primary|Number of Subjects With Potential Immune-Mediated Disease(s) (pIMDs)|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|During the entire study period (From Day 0 to Month 7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2650363|NCT01669096|Primary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related AE = an AE assessed by the investigator as causally related to the study vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2650364|NCT01669096|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were Fatigue, Gastrointestinal symptoms, Headache, Malaise, Myalgia and Fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = incidence of any particular symptom regardless of intensity grade. Grade 3 = incidence of a particular symptom that prevented normal, everyday activity. Grade 3 fever = axillary temperature above (>) 39.5 °C. Related = general symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2650365|NCT01669096|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2650864|NCT01665053|Secondary|Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.|All CEC adjudicated revascularization at 12 month (Intent to treat population).|12 Month|Intent to treat population|||percentage of patients|||Number
2650367|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63)|Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M57=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M58=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M59=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M60=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M61=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M62=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M63=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+).|At Day 60 post Dose 2|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650368|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M43 to M56)|Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M43=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M44=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M45=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M46=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M47=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M48=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M49=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M50=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M51=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M52=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M53=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M54=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M55=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M56=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-).|At Day 60 post-Dose 2|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650369|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42)|Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M29=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M30=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M31=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M32=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M33=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M34=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M35=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M36=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M37=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M38=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M39=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M40=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M41=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M42=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+).|At Day 60 post- Dose 2|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650370|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28)|Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M15=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M16=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M17=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M18=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M19=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M20=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M21=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M22=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M23=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M24=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M25=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M26=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M27=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M28=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+).|At Day 60 post -Dose 2|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650371|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14)|Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M1=CD8.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M2=CD8.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M3=CD8.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M4=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M5=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M6=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M7=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M8=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M9=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M10=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M11=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M12=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M13=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M14=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+).|At Day 60 post-Dose 2|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650415|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Receptor for Advanced Glycation End Products (RAGE) Gene Expression|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~RAGE gene expression~Arbitrary unit was relative to the control gene expression (control gene = 1)"|30 days post-treatment||||arbitrary unit relative to control gene||Standard Deviation|Mean
2650372|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M57 to M63)|Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M57=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M58=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M59=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M60=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M61=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M62=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M63=CD8_CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+).|At Day 0 (prior to Dose 1)|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650373|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M43 to M56)|Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M43=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M44=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M45=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M46=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M47=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M48=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M49=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M50=CD8.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M51=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M52=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M53=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M54=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M55=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M56=CD8_CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-).|At Day 0 prior to Dose 1|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650374|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M29 to M42)|Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M29=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M30=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M31=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M32=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M33=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M34=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M35=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M36=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M37=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M38=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M39=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M40=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M41=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M42=CD8.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+).|At Day 0 prior- Dose 1|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650375|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M15 to M28)|Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M15=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M16=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M17=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M18=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M19=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M20=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M21=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M22=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M23=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M24=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M25=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M26=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M27=CD8.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M28=CD8.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+).|At Day 0 prior -Dose 1|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650376|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD8+ T Cells Expressing Any Combination of Immune Markers (M1 to M14)|Expressed immune markers combinations for CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M1=CD8.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M2=CD8.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M3=CD8.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M4=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M5=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M6=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M7=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M8=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M9=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M10=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M11=CD8.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M12=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M13=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M14=CD8.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+).|At Day 0 prior-Dose 1|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650416|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Estrone and Norepinephrine.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- estrone, norepinephrine."|30 days post-treatment||||"pg/dL"||Standard Deviation|Mean
2650865|NCT01665053|Secondary|Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.||12 month|Intent-to-Treat population|||percentage of participants|||Number
2650377|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M57 to M63)|Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M57=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M58=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M59=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M60=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M61=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M62=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M63=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+).|At Day 60 post- Dose 2|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650378|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers,Post Dose 2 (M43 to M56)|Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M43=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M44=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M45=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M46=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M47=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M48=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M49=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M50=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M51=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M52=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M53=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M54=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M55=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M56=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-).|At Day 60 (post-Dose 2)|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650379|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M29 to M42)|Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M29=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M30=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M31=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M32=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M33=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M34=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M35=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M36=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M37=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M38=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M39=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M40=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M41=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M42=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+).|At Day 60 post Dose 2|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650380|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M15 to M28)|Expressed immune markers combinations for CD4+/CD8+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M15=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M16=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M17=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M18=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M19=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M20=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M21=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M22=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M23=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M24=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M25=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M26=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M27=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M28=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-).|At Day 60 post - Dose 2|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650381|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers, Post Dose 2 (M1 to M14)|Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M1=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M2=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M3=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M4=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M5=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M6=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M7=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M8=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M9=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M10=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M11=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M12=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M13=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M14=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-).|At Day 60 post-Dose 2|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650417|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Biomarkers|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- non-esterified fatty acids, insulin, luteinizing hormone, follicle stimulating hormone."|30 days post-treatment||||"microUI/mL"||Standard Deviation|Mean
2650382|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M57 to M63)|Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M57=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M58=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M59=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M60=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M61=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M62=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M63=CD4.CD40L(-)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+).|At Day 0 (prior to Dose 1)|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650383|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M43 to M56)|Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M43=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M44=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M45=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M46=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M47=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M48=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M49=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M50=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M51=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M52=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M53=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M54=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M55=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M56=CD4.CD40L(-)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-).|At Day 0 (prior- Dose 1)|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650384|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M29 to M42)|Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M29=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M30=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-); M31=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M32=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M33=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M34=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M35=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M36=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M37=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M38=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M39=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M40=CD4.CD40L(-)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M41=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M42=CD4.CD40L(-)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+).|At Day 0 prior - Dose 1|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650385|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M15 to M28)|Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M15=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(+); M16=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(-)+IL-13(-); M17=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M18=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M19=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M20=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M21=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M22=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M23=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M24=CD4.CD40L(+)+IL-2(-)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M25=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M26=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M27=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M28=CD4.CD40L(+)+IL-2(-)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-).|At Day 0 prior-Dose 1|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650386|NCT01669096|Primary|Frequency of M72 Specific Cluster of Differentiation CD4+ T Cells Expressing Any Combination of Immune Markers (M1 to M 14)|Expressed immune markers combinations for CD4+ T cells included CD40-L, IL-2, TNF-α, IFN-γ, IL-17 and IL-13, as follows: M1=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(+); M2=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(+)+IL-13(-); M3=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(+); M4=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(+)+IL-17(-)+IL-13(-); M5=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(+); M6=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(+)+IL-13(-); M7=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(+); M8=CD4.CD40L(+)+IL-2(+)+TNF-α(+)+IFN-γ(-)+IL-17(-)+IL-13(-); M9=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(+); M10=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(+)+IL-13(-); M11=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(+); M12=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(+)+IL-17(-)+IL-13(-); M13=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(+); M14=CD4.CD40L(+)+IL-2(+)+TNF-α(-)+IFN-γ(-)+IL-17(+)+IL-13(-).|At Day 0 prior -Dose 1|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650418|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Platelet Aggregation.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- platelet aggregation by ADP and norepinephrine."|30 days post-treatment||||percentage platelet aggregation||Standard Deviation|Mean
2674988|NCT01451398|Secondary|Incidence of Severe Hypoglycemia|Severe Hypoglycemia defined as: Requiring 3rd party assistance.|Baseline to Week 24|Safety population|||percentage of participants|||Number
2650387|NCT01669096|Primary|Frequency of M72 Fusion Protein Specific Cluster of Differentiation CD4+/CD8+ T Cells Expressing at Least Two Different Immune Markers|Among immune markers expressed were interleukin-2 (IL-2) and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ) and/or cluster of differentiation 40-ligand [CD40-L] and/or IL-13 and/or IL-17. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs).|At Day 60 post-Dose 2|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650388|NCT01669096|Primary|Frequency of Mycobacterium Tuberculosis Fusion Protein (M72) Specific Cluster of Differentiation CD4+/CD8+ T Cells Expressing at Least Two Different Immune Markers|Among immune markers expressed were interleukin-2 (IL-2) and/or tumour necrosis factor-alpha (TNF-α) and/or interferon-gamma (IFN-γ) and/or cluster of differentiation 40-ligand (CD40-L) and/or IL-13 and/or IL-17. The analysis of cytokines expression was performed by flow cytometry using intracellular cytokine staining (ICS) on frozen peripheral blood mononuclear cell (PBMCs).|At Day 0 prior to Dose 1|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||T cells/million cells||Inter-Quartile Range|Median
2650389|NCT01669096|Primary|Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples|Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.|At Day 47 post-Dose 2|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||fg/mL||95% Confidence Interval|Geometric Mean
2650390|NCT01669096|Primary|Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples|Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.|At Day 44 post-Dose 2|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||fg/mL||95% Confidence Interval|Geometric Mean
2650391|NCT01669096|Primary|Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples|Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.|At Day 40 post-Dose 2|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||fg/mL||95% Confidence Interval|Geometric Mean
2650392|NCT01669096|Primary|Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples|Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.|At Day 37 post-Dose 2|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||fg/mL||95% Confidence Interval|Geometric Mean
2650393|NCT01669096|Primary|Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples|Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.|At Day 31 post-Dose 2|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||fg/mL||95% Confidence Interval|Geometric Mean
2650394|NCT01669096|Primary|Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples|Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.|At Day 30 post-Dose 1|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||fg/mL||95% Confidence Interval|Geometric Mean
2650395|NCT01669096|Primary|Concentration of Specific Interferon Gamma (IFN-γ) Antibodies Secreted in Serum Samples|Antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in femtogram per milliliter (fg/mL), as assessed by cytometric bead array (CBA) assay. The reference seropositivity cut-off value was equal to or above (≥) 7047 fg/mL.|At Day 0 prior to Dose 1|The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects included in the Total Vaccinated cohort who met all eligibility criteria and for whom post-vaccination blood samples were available for the considered timepoint and assay assessed.|||fg/mL||95% Confidence Interval|Geometric Mean
2650419|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Estradiol|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- estradiol"|30 days post-treatment||||"pg/mL"||Standard Deviation|Mean
2651440|NCT01662102|Secondary|Event Free Survival|EFS time is defined as the time from randomization to first documented progression, death from any cause, or introduction of a new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy).|Up to 7 years|||||||
2650396|NCT01668966|Secondary|CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points|HAQ-DI is a self-reported participant questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Total score for HAQ-DI is the sum of all questions and ranges from 0 = without any difficulty to 60 = unable to do. A negative CFB indicates improvement.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)|ITT population. Here, 'n' represents the number of participants available for assessment at a given time point.|||units on a scale||Standard Deviation|Mean
2650397|NCT01668966|Secondary|CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points|"PhGA of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as maximum disease activity (maximum arthritis disease activity)."|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)|ITT population. Here, 'n' represents the number of participants available for assessment at a given time point.|||mm||Standard Deviation|Mean
2650398|NCT01668966|Secondary|CFB in PGA of Pain Using VAS Score at Specified Time Points|"PGA of pain is assessed on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm, and is described as unbearable pain. A negative change indicated improvement."|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)|ITT population. Here, 'n' represents the number of participants available for assessment at a given time point.|||mm||Standard Deviation|Mean
2650399|NCT01668966|Secondary|CFB in PGA of Disease Activity Using VAS Score at Specified Time Points|"PGA of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative CFB indicated improvement."|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)|ITT population. Here, 'n' represents the number of participants available for assessment at a given time point.|||mm||Standard Deviation|Mean
2650400|NCT01668966|Secondary|Time to RA Crisis Among Participants Who Discontinued After Clinical Remission|RA crisis is any worsening of participant disease acitivity that, in the opinion of the investigator, required intensified treatment other than supportive therapy, and may have included restart of the treatment with the study drug. Time to RA crisis is defined as the period of remission without drug until the RA crisis documentation.|Baseline up to approximately 104 weeks|ITT population|||days||Standard Deviation|Mean
2650401|NCT01668966|Secondary|Percentage of Participants Reaching Clinical Remission (DAS28-ESR Score Less Than [<] 2.6 and/or SDAI Score Less Than or Equal to [</=] 3.3) Among Participants for Whom Tocilizumab Treatment Was Discontinued|Remission: DAS28-ESR score <2.6 and SDAI score </=3.3. DAS28-ESR index included SJC and TJC, both scored 0-28, as well as APR determined as ESR in mm/hr, and GH (ranges 1-100 mm; higher scores=higher disease activity). DAS28=(0.56*√TJC)+(0.28*√SJC) +(0.70*ln ESR) +(0.014*GH). DAS28-ESR scale is transformed and ranges from 0 to 10. Negative CFB indicated improvement. DAS28 >2.6 (clinical remission); DAS28 2.6 to 3.2 (low disease activity); DAS28 >3.2 to 5.1 = moderate to high disease activity. SDAI is sum of TJC and SJC (both scored 0-28), PhGA and PGA of disease activity (both scored 0 to 10 cm as assessed by VAS, higher scores=higher disease activity), and CRP in mg/dL where normal is <1 mg/dL. SDAI=TJC + SJC + PhGA + PGA + CRP. SDAI ranged from 0 to 86. A negative CFB indicated improvement. SDAI <=3.3 (clinical remission), >3.4 to 11 (low disease activity) >11 to 26 (moderate disease activity), and >26 = (high/severe disease activity).|Baseline up to approximately 104 weeks|ITT population|||percentage of participants|||Number
2650402|NCT01668966|Secondary|CFB in Tender Joint Count (TJC) at Specified Time Points|The number of tender joints is recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 68 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)|ITT population. Here, 'n' represents the number of participants available for assessment at a given time point.|||tender joints||Standard Deviation|Mean
2650403|NCT01668966|Secondary|CFB in Swollen Joint Count (SJC) at Specified Time Points|For SJC, a total of 66 joints are assessed. The presence of a swollen joint is scored as 1 and absence as 0. Total score is calculated by adding the scores, which ranges from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicated no swollen joint and higher scores indicated worsening swollen joints.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)|ITT population. Here, 'n' represents the number of participants available for assessment at a given time point.|||swollen joints||Standard Deviation|Mean
2650420|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Apolipoproteins AI and B.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- apolipoproteins AI and B"|30 days post-treatment||||"g/dL"||Standard Deviation|Mean
2650421|NCT01668836|Primary|Sirtuin|Sirtuin plasma levels before and 30 days post-treatment|30 days post-treatment||||ng/mL||Standard Deviation|Mean
2650422|NCT01668836|Other Pre-specified|Differences Between Men and Women.|We will also compare women vs men baseline and final data.|30 days|||||||
2651441|NCT01662102|Secondary|Complete Response Rate|Complete Response (CR) rates post randomization|Up to 24 months|||||||
2650404|NCT01668966|Secondary|CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points|The SDAI is a combined index for measuring disease activity. SDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), physician global assessment (PhGA) and PGA of disease activity, both scored 0 to 10 centimeters (cm) as assessed by VAS, and C-reactive protein level (CRP) in milligrams per deciliter (mg/dL) where normal is less than (<) 1 mg/dL. SDAI is calculated according to the following formula: SDAI = TJC + SJC + PhGA + PGA + CRP. SDAI ranges from 0 to 86. A negative CFB indicated improvement.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)|ITT population. Here, 'n' represents the number of participants available for assessment at a given time point.|||units on a scale||Standard Deviation|Mean
2650405|NCT01668966|Secondary|Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points|The DAS28-ESR is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) (patient global assessment of disease activity [PGA] using visual analog scale [VAS], range 1-100 millimeters [mm]) (higher scores indicate higher disease activity). DAS28-ESR is calculated according to the following formula: DAS28-ESR equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + (0.70 * the natural logarithm [ln] ESR in mm/h) + (0.014*GH in mm VAS). DAS28-ESR scale is transformed and ranges from 0 to 10. A negative CFB indicated improvement.|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)|ITT population. Here, 'n' represents the number of participants available for assessment at a given time point.|||units on a scale||Standard Deviation|Mean
2650406|NCT01668966|Primary|Percentage of Participants With TEAEs Leading to Change in Dose or Study Drug Discontinuation|An AE is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started.|Baseline up to approximately 104 weeks|ITT population|||percentage of participants|||Number
2650407|NCT01668966|Primary|Percentage of Participants With TEAEs of Special Interest|An AE is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started. Nine categories of AE of special interest are identified for tocilizumab which includes a) serious/medically significant infections, b) myocardial infarction/acute coronary syndrome, c) gastrointestinal perforations, d) malignancies, e) anaphylaxis/hypersensitivity reactions, f) demyelinating disorders, g) stroke, h) serious and/or medically significant bleeding events, and i) serious/medically significant hepatic events. Data reported is an average of the nine categories.|Baseline up to approximately 104 weeks|ITT population|||percentage of participants|||Number
2650408|NCT01668966|Primary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An adverse event (AE) is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started. An SAE can be a) fatal, b) life-threatening, c) requires/prolongs hospitalization, d) results in persistent/significant incapacity/disability, e) results in congenital anomaly/birth defect or f) is considered as a significant medical event by the investigator.|Baseline up to approximately 104 weeks|ITT population|||percentage of participants|||Number
2650409|NCT01668940|Secondary|Freezie Flavour Preference|To assess preference for freezie flavours.|Baseline, +1, +3, +5, +7 days|||||||
2650410|NCT01668940|Secondary|Concurrent Symptoms|To assess if there are any changes to concurrent symptoms that may intensify NVP, such as metallic taste or gastrointestinal issues (e.g. heartburn, acid reflux, indigestion and gas). The secondary endpoint of interest is the effect of the 4 groups on the status of concurrent symptoms that may intensify NVP, such as metallic taste or gastroesophageal reflux disease, as well as preference for freezie flavours, according to the PUQE-24 (pregnancy-unique quantification of emesis and nausea) scoring system for nausea and vomiting of pregnancy that was developed and validated by Motherisk.|Baseline, +1, +3, +5, +7 days|||||||
2650411|NCT01668940|Primary|Improvement of Nausea and Vomiting of Pregnancy (NVP)|To assess the effectiveness of Lillipops in the improvement of NVP symptoms. The primary endpoint of interest is the severity of NVP as compared between the 4 groups, defined according to the PUQE-24 (pregnancy-unique quantification of emesis and nausea) scoring system for nausea and vomiting of pregnancy that was developed and validated by Motherisk.|Baseline, +1, +3, +5, +7 days|The study was terminated due to the original study PI's departure, and the final analyses have not been conducted. The study file has been locked in 2015 after the official study closure.||||||
2650412|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Max Elasticity of Clot on Thromboelastography.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~-max elasticity of clot on thromboelastography"|30 days post-treatment||||"Pascal"||Standard Deviation|Mean
2650413|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Thromboelastography.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- slope of clot formation dynamics"|30 days post-treatment||||"Pascal/min"||Standard Deviation|Mean
2650414|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Thromboelastography Clot Formation.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~-dynamics of clot formation: clot onset time and clot complet"|30 days post-treatment||||"sec"||Standard Deviation|Mean
2650423|NCT01668836|Secondary|Influence of the Sirtuin 1 System on Lipid Profile, Glucose, and C-reactive Protein.|"For indirect analysis of the sirtuin 1 system, the following procedures will be done before and after the intervention with caloric restriction or resveratrol administration:~- serum HDL, LDL, lipoprotein(a), C reactive protein, glucose."|30 days post-treatment||||"mg/dL"||Standard Deviation|Mean
2650425|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Anxiety/Depression Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
2650426|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Anxiety/Depression Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
2650427|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
2650428|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
2650429|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Disorganized Thought Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
2650430|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Disorganized Thought Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
2650431|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Negative Symptoms Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
2650583|NCT01667796|Primary|Change in Mean Serum Level of 25-hydroxyvitamin D|Generalized estimating equations (GEE) with an autoregressive with lag one correlation matrix were used to compare the serially-measured serum 25(OH)D levels between MS patients and Healthy Controls (HCs) to take into account repeated measures and within-subject correlations.|Baseline to 90 days||||nmol/L||Standard Deviation|Mean
2650432|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Negative Symptoms Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
2650433|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Positive Symptoms Score - LOCF Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score is the sum of the 8 components of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
2650434|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Marder Factor Scores: Positive Symptoms Score - MMRM Analysis|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score is the sum of the 8 components of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
2650435|NCT01668797|Other Pre-specified|Mean Change From Baseline in PEC Score - LOCF Analysis|The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
2650436|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Excited Component (PEC) Score - MMRM Analysis|The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe).|Baseline and Weeks 6, 12, 24, 36 and 52|The last-observation-carried-forward (LOCF) data set included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data (eg.the last visit prior to the first dosing of Phase C) were not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
2650437|NCT01668797|Other Pre-specified|Percentage of Participants Who Discontinued Due to All Causes|Analysis of the percentage of participants who discontinued due to all causes was based on all participants who have been randomized and taken one dose of IMP in the Double-blind Maintenance phase. The trial was completed by sponsor when efficacy was demonstrated at the first pre-specified interim analysis (45 impending relapse events) performed by an independent (unblinded) statistician.|Baseline to Week 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Percentage of particpants|||Number
2650438|NCT01668797|Other Pre-specified|Mean Change From Baseline in GAF Scale Score - LOCF Analysis|The GAF is a clinician-rated scale that assesses the participant's psychological, social, and occupational functioning on a hypothetical continuum of mental health-illness using a scale that ranges from 1 to 100 score, where lower values indicate worst outcome. From among 10 descriptive anchors, investigators will choose the anchor which is the most representative of the participant's level of functioning at the time of the assessment and will assign a single score within the point range given for the selected anchor.|Baseline and Weeks 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
2650439|NCT01668797|Other Pre-specified|Mean Change From Baseline in Global Assessment of Functioning (GAF) Scale Score - MMRM Analysis|The GAF is a clinician-rated scale that assesses the participant's psychological, social, and occupational functioning on a hypothetical continuum of mental health-illness using a scale that ranges from 1 to 100 score, where lower values indicate worst outcome. From among 10 descriptive anchors, investigators will choose the anchor which is the most representative of the participant's level of functioning at the time of the assessment and will assign a single score within the point range given for the selected anchor.|Baseline and Weeks 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
2651624|NCT01660893|Secondary|Intraoral Soft-tissue Anesthesia (Yes/no)|Number of patients who reported no pain when incisive papilla and greater palatine foramen soft-tissue was tested with a probe|at 15 minutes with a 3 minute window||||Participants|||Count of Participants
2650440|NCT01668797|Other Pre-specified|Mean Change From Baseline in PSP Scale Score - LOCF Analysis|The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains: socially useful activities (e.g., work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains is rated as absent, mild, manifest, marked, severe, or very severe. These ratings are then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 are considered to have mild functional difficulty. Scores of 31 to 70 represent manifest disabilities of various degrees and ratings of 1 to 30 indicate minimal functioning that requires intense support and/or supervision.The PSP score ranges from 0 to 100, with higher scores indicating higher levels of social functioning.|Baseline and Weeks 24 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
2650441|NCT01668797|Other Pre-specified|Mean Change From Baseline in Personal and Social Performance (PSP) Scale Score - MMRM Analysis|The PSP is a validated clinician-rated scale that measures personal and social functioning in four domains: socially useful activities (e.g., work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains is rated as absent, mild, manifest, marked, severe, or very severe. These ratings are then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 are considered to have mild functional difficulty. Scores of 31 to 70 represent manifest disabilities of various degrees and ratings of 1 to 30 indicate minimal functioning that requires intense support and/or supervision.The PSP score ranges from 0 to 100, with higher scores indicating higher levels of social functioning.|Baseline and Weeks 24 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
2650442|NCT01668797|Other Pre-specified|Clinical Global Impression - Improvement Score (CGI-I) at Endpoint - LOCF Analysis|The rater or investigator would rate the participant's total improvement whether or not it is due entirely to study treatment. During Phase B, responses were compared to the participant's condition at Baseline of Phase B (for participants who entered Phase B directly after screening) or to the End of Phase A visit (for participants who participated in Phase A). During Phase C, responses were compared to the participant's condition at the End of Phase B visit. Response choices include: 0 = Not assessed, 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, and 7 = Very much worse.|Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Deviation|Mean
2650443|NCT01668797|Other Pre-specified|Change From Baseline in CGI-S Score at Endpoint - LOCF Analysis|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
2650444|NCT01668797|Other Pre-specified|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint - MMRM Analysis|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline, Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
2650445|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Negative Subscale Score - LOCF Analysis|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
2650465|NCT01668667|Secondary|The Dose-response Relationship of Change From Baseline in IRLS Rating Scale Total Score at End of Treatment|"International Restless Legs Syndrome Rating Scale: Very severe=31-40, Severe=21-30, Moderate=11-20, Mild=1-10, None=0.~This model only includes treatment in the model. Least squares mean is used for analysis."|Baseline, 12 Weeks|mITT (modified intent to treat) Population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.|||units on a scale||Standard Error|Least Squares Mean
2650446|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Negative Subscale Score - MMRM Analysis|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
2650447|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Positive Subscale Score - LOCF Analysis|PANSS consisted of three subscales: a total of 30 symptom constructs. For each construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
2650448|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Positive Subscale Score - MMRM Analysis|PANSS consisted of three subscales: a total of 30 symptom constructs. For each construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
2650449|NCT01668797|Other Pre-specified|Mean Change From Baseline in PANSS Total Score - Last-observation-carried-forward (LOCF) Analysis|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|The LOCF data set for Phase C included data recorded at a given Phase C visit or, if no observation is recorded at that visit, data carried forward from the previous Phase C visit. Baseline data was not be carried forward to impute missing values for the LOCF data set.|||Units on a scale||Standard Error|Least Squares Mean
2650450|NCT01668797|Other Pre-specified|Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score - MMRM Analysis|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline and Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Units on a scale||Standard Error|Least Squares Mean
2650451|NCT01668797|Other Pre-specified|Percentage of Participants Meeting Stability Criteria in Double Blind Maintenance Phase|"Participants were assessed for stability using the following criteria:1) Outpatient status AND 2) Positive and Negative Syndrome Scale (PANSS) Total Score ≤ 70 AND 3) A score of ≤ 4 (moderate) on each of the following PANSS items (possible scores of 1 to 7 for each item): conceptual disorganization, suspiciousness hallucinatory behavior, unusual thought content, AND 4) Clinical Global Impression - Severity of Illness scale(CGI-S) score ≤ 4 (moderately ill) AND 5) No current suicidal behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS), defined as the following: An answer of no to each question on the Suicidal Behavior section of the C-SSRS AND an answer of no to Questions 4 and 5 on the Suicidal Ideation section of the C-SSRS, if completed, AND 6) No evidence of aggressive or violent behavior resulting in clinically significant self-injury, injury to another person, property damage."|Weeks 6, 12, 24, 36 and 52|Based on ITT principle, the full analysis set of this trial was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||percentage of participants|||Number
2650466|NCT01668667|Primary|"The Proportion of Subjects at the End of Treatment Who Are Responders With Either Much Improved or Very Much Improved on the Investigator-rated Clinical Global Impression of Improvement (CGI-I)"|Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 12 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved.|12 weeks|mITT (modified intent to treat) population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.|||percentage of participants|||Number
2650452|NCT01668797|Secondary|Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria in the Double-blind Maintenance Phase|"Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or an increase on any of the following individual PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual though content) to a score of >4 and an absolute increase of ≥ 4 on the combined 4 PANSS items. OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Current suicidal behavior as assessed by the C-SSRS (ie, an answer of yes to any of the questions on the suicidal behavior section of the C-SSRS 5) Violent or aggressive behavior resulting in clinically significant self-injury to another person, or property damage."|Baseline and Week 52/Early Termination|Based on ITT principle, the full analysis set of this trial was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||percentage of participants|||Number
2650453|NCT01668797|Primary|Time From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse in Phase C.|"The primary efficacy variable was time to impending relapse from randomization, as assessed by Clinical Global Impression of Improvement (CGI-I) score ≥5, Positive and Negative Syndrome Scale (PANSS) scores for hostility or uncooperativeness ≥5, or ≥20% increase in PANSS Total Score. Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score >4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content).OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of yes to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.The measure type, number is Hazard Ratio."|From randomization to time of exacerbation of psychotic symptoms/impending relapse - up to 52 weeks|Based on the Intent-to-Treat (ITT) principle, the full analysis set of this trial was composed of all participants randomized to the double-blind treatment who took at least one dose of study medication in Phase C and who had at least one post-randomization efficacy evaluation in Phase C.|||Days||95% Confidence Interval|Number
2650454|NCT01668784|Secondary|Number of Participants With Abnormal Hematology and Serum Chemistry Laboratory Parameters by Worse CTC Grade - SI Units|Common Terminology Criteria (CTC) version 4.0 in International System of Units (SI); Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Hematology parameters=Hemoglobin (Gr 3: < 8.0 g/dL), Platelet Count (Gr 3: 25.0 -< 50.0*10^9 c/L; Gr 4: < 25.0*10^9 c/L), Leukocyte Count (Gr 3: 1.0 -< 2.0*10^3 c/µL; Gr4: < 1.0*10^3 c/µL), Absolute Lymphocyte Count (Gr 3: 0.2 -< 0.5*10^3 c/µL; Gr 4: < 0.2*10^3 c/µL), Absolute Neutrophil Count (Gr 3: 0.5 - < 1.0*10^3 c/µL; Gr 4: < 0.5*10^3 c/µL). Liver Function parameters=Alkaline Phosphatase (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), AST (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), ALT (Gr 3: > 5.0 - 20.0 U/L * ULN; Gr 4: > 20.0 U/L * ULN), tBIL (Gr 3: > 3.0 - 10.0 mg/dL * ULN; Gr 4: > 10.0 mg/dL * ULN). Renal parameter=Creatinine (Grade: Gr3: > 3.0 - 6.0 mg/dL *ULN; Gr4: > 6.0 mg/dL *ULN). Cells per microliter (c/µL). Cells per Liter (c/L). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).|Day 1 to 30 days post last dose, up to May 2015 (approximately 30 months)|All treated participants; all participants who received at least one dose of nivolumab or everolimus and at least one measureable on-treatment measurement of the corresponding laboratory parameter|||participants|||Number
2650455|NCT01668784|Secondary|Number of Participants Meeting Marked Laboratory Abnormality Criteria in Specific Liver and Thyroid Tests at Primary Endpoint|Aspartate aminotransferase, AST. Alanine aminotransaminase, ALT. Total bilirubin, tBIL. Thyroid stimulating hormone, TSH. Upper limit of normal (ULN). Units per Liter (U/L). Results reported in International System of Units (SI).|Day 1 to 30 days post last dose, up to May 2015 (approximately 30 months)|All treated participants who received at least one dose of nivolumab or everolimus and had at least one measureable on-treatment measurement of the corresponding laboratory parameters|||participants|||Number
2650456|NCT01668784|Secondary|Percentage of Participants With Disease-related Symptom Progression (DRSP) at Primary Endpoint|Disease-related symptom progression rate (DRSPR)=a decrease of two points in the Functional Assessment of Cancer Therapy-Kidney Symptom Index - Disease Related Symptoms (FKSI-DRS) questionnaire relative to the participant's baseline FKSI-DRS score with no later increase above this threshold observed during the course of the study. The 9 items of the FKSI-DRS were summarized into a symptom scale ranging in score from 0 to 36, with 0 being the worst possible score and 36 being the best possible score. A single measure reporting a decrease of at least 2 units was considered disease-related symptom progression only if it was the last one available for the participant. In order to consider a questionnaire received as valid, over 50% of the items were to be completed. Calculated by the Clopper-Pearson method for each treatment group.|Randomization until 398 deaths, up to May 2015 (approximately 30 months)|All randomized participants; any participants that was randomized to any treatment group in the study.|||percentage of participants||95% Confidence Interval|Number
2650457|NCT01668784|Secondary|Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events at Primary Endpoint|Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Day of first dose to 30 days post final dose, up to May 2015 (approximately 30 months)|All treated participants; all participants who received at least one dose of nivolumab or everolimus|||participants|||Number
2650485|NCT01668654|Primary|Change From Baseline in the Hematocrit Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Hematocrit was measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
2650458|NCT01668784|Secondary|Overall Survival (OS) by Programmed Death-Ligand 1 (PD-L1) Expression Level at Primary Endpoint|Quantifiable PD-L1 expression=percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay. If the PD-L1 staining could not be quantified it was classified as: indeterminate=tumor cell membrane staining hampered for reasons attributed to biology of tumor biopsy specimen and not due to improper sample preparation or handling; not evaluable=tumor biopsy specimen was not optimally collected or prepared. Not evaluable determined from H&E process before the tumor biopsy specimen was sent for evaluation or from H&E process during PD-L1 evaluation; baseline PD-L1 expression=if more than one tumor biopsy specimen was available, the most recently collected specimen with a quantifiable result. If all specimens for a given participant are either indeterminate or not evaluable, then the PD-L1 expression was considered indeterminate as long as at least one specimen is indeterminate. Otherwise, PD-L1 expression was considered not evaluable.|Randomization to date of death or date of last contact for patients without documentation of death, up to May 2015 (approximately 30 months)|PD-L1 quantifiable participants; All randomized participants with quantifiable PD-L1 expression at baseline|||months||95% Confidence Interval|Median
2650459|NCT01668784|Secondary|Investigator-assessed Time of Progression-free Survival (PFS) at Primary Endpoint|PFS=time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. Participants who die without a reported prior progression and without subsequent anti-cancer therapy were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the date they were randomized. Participants who received any subsequent anti-cancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to or on initiation date of the subsequent anti-cancer therapy. Progressive disease: >=20% increase in sum of target lesion diameters and sum must show absolute increase of >=5mm; smallest sum on study as reference. Based on Kaplan-Meier Estimates.|Randomization until 398 deaths, up to May 2015 (approximately 30 months)|All randomized participants; any participants that was randomized to any treatment group in the study.|||months||95% Confidence Interval|Median
2650460|NCT01668784|Secondary|Investigator-assessed Time to Objective Response at Primary Endpoint|Time to objective response is defined as the time from randomization to first response (complete response, CR or partial response, PR). CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference.|Randomization to date of first response, up to May 2015 (approximately 30 months)|All randomized participants with a response; any participants that was randomized to any treatment group in the study and that had a response.|||months||Full Range|Median
2650461|NCT01668784|Secondary|Investigator-assessed Duration of Objective Response at Primary Endpoint|Duration of objective response is defined as the time from first response (complete response, CR or partial response, PR) to the date of the first documented tumor progression as determined by the investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. For participants who neither progress nor die, the duration of objective response were censored at the same time they were censored for the primary definition. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Based on Kaplan-Meier Estimates.|From date of first response to date of disease progression or death or censoring if no progression or death occurred, up to May 2015 (approximately 30 months)|All randomized participants with a response; any participants that were randomized to any treatment group in the study and that had a response.|||months||95% Confidence Interval|Median
2650462|NCT01668784|Secondary|Investigator-assessed Objective Response Rate (ORR) at Primary Endpoint|ORR=number of participants with a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR=At least a 30% decrease in the sum of diameters of target lesions, the baseline sum diameters used as reference. Tumor assessments began at 8 weeks following randomization and continued every 8 weeks for the first year, then every 12 weeks thereafter until disease progression or death. CIs used Clopper and Pearson.|At 8 weeks post randomization, every 8 weeks for 12 months, and every 12 weeks until date of disease progression or death, up to May 2015 (approximately 30 months)|All randomized participants; any participants that was randomized to any treatment group in the study.|||percentage of participants||95% Confidence Interval|Number
2650463|NCT01668784|Primary|Overall Survival (OS) at Primary Endpoint|"Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred after 398 deaths (70% of the total OS events needed for final analysis). At that time the data monitoring committee noted that the pre-specified boundary for OS (nominal significance level p < 0.0148) was crossed while no new safety signals that would affect continuation of the study were found.~The study was stopped early by the Sponsor, Bristol-Myers Squibb (BMS) and the interim analysis became the final analysis. As a result, participants in the everolimus groups could be assessed for a crossover to nivolumab treatment if they met all inclusion criteria."|Randomization until 398 deaths, up to May 2015 (approximately 30 months)|All randomized participants; any participants that was randomized to any treatment group in the study.|||months||95% Confidence Interval|Median
2650464|NCT01668667|Secondary|The Dose-response Relationship for Investigator-rated CGI-I Scale at End of Treatment||12 Weeks|mITT (modified intent to treat) Population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.|||percentage of participants|||Number
2650584|NCT01667731|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2650467|NCT01668667|Primary|The Change From Baseline to the End of Treatment in the International Restless Legs Syndrome (IRLS) Rating Scale Score|"International Restless Legs Syndrome Rating Scale: Very severe=31-40, Severe=21-30, Moderate=11-20, Mild=1-10, None=0.~Change from Baseline = LOCF value at current visit - value at Baseline (the last nonmissing assessment before the first dose of study medication). A negative treatment difference indicates a benefit relative to placebo.~The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate."|Baseline, 12 weeks|mITT (modified intent to treat) Population: The mITT population will include all randomly assigned subjects who received at least 1 dose (or any portion of a dose) of study medication as defined above for the Safety population, have a baseline IRLS Rating Scale total score, and have at least 1 on-treatment IRLS Rating Scale total score.|||units on a scale||Standard Error|Mean
2650468|NCT01668654|Secondary|Apparent Clearance (CL/F) Following Oral Administration of Retigabine/Ezogabine at Indicated Time Points|Blood samples for population pharmacokinetic analysis of retigabine/ezogabine were taken at clinic visits where routine clinical laboratory samples were also taken. CL/F, where CL is the calculated as dose/AUC and F is the oral bioavailability of the drug. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled|Eligbility Assessment (Visit 1), up to 178 days|All Subjects Population||||||
2650469|NCT01668654|Secondary|Area Under the Plasma Concentration-time Curve (AUC) Following Oral Administration of Retigabine/Ezogabine at the Indicated Time Points|AUC is defined as the area under the plasma drug concentration-time curve, reflects the actual body exposure to drug after administration of a dose of the drug and is expressed in milligram*hour per Liter (mg*h/L). Blood samples for population PK analysis of retigabine/ezogabine were taken at clinic visits where routine clinical laboratory samples were also taken. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population||||||
2650470|NCT01668654|Secondary|Change From Baseline in Child Health Status as Measured by the Child Health Questionnaire (CHQ) in Participants <18 Years Old at the Indicated Time Points|The CHQ comprises scales specifically developed for children and adolescents aged five years and older. The CHQ assesses a child's physical, emotional, and social well-being from the perspective of a parent or guardian. The questionnaire was completed by a parent/caregiver and administration time was approximately 30 minutes. The parent/caregiver completed this questionnaire while the participant was within the age range (i.e. <18 years). Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibilty Assessment (Visit 1), EW Visit and FU Visit (up to 178 days)|All Subjects Population||||||
2650471|NCT01668654|Secondary|Clinical Global Impression-Severity of Illness (CGI-S) Assessment at the Indicated Time Points|The Clinical Global Impression (CGI) scale provided an overall clinician-determined summary measure. It had 2 components: the CGI-Severity of Illness (CGI-S) scale and the CGI-Improvement (CGI-I) scale which rated the change from Baseline. The CGI-S was a 7-point scale that required the investigator to rate the severity of the participant's epilepsy relative to the investigator's past experience with other participants with the same diagnosis. The CGI-S scale scores range from 0 to 7 and are interpreted as 0=not assessed, 1=normal, 2=borderline, 3=mild, 4=moderate, 5=marked, 6=severe, 7=extremely severe. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population||||||
2650472|NCT01668654|Secondary|Clinical Global Impression- Improvement (CGI-I) Assessment at the Indicated Time Points|The Clinical Global Impression (CGI) scale provided an overall clinician-determined summary measure. It had 2 components: the CGI-Severity of Illness (CGI-S) scale and the CGI- Improvement (CGI-I) scale which rated the change from Baseline. The CGI-I scale scores range from 0 to 7 and are interpreted as 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population||||||
2650473|NCT01668654|Secondary|Number of Participants Who Were Responders During the Treatment Period|A ''responder'' is defined as >50% reduction from Baseline in the seizure frequency. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population||||||
2650474|NCT01668654|Secondary|Percent Change From Baseline in the Seizure Frequency at the Indicated Time Points|The percentage reduction from Baseline in the seizure frequency was summarized using descriptive statistics. The frequencies and percentages were computed for a reduction in seizure frequency of >50% as well as for a 100% reduction (seizure-free). Increases of >50% in seizure frequency was also summarized. The percentage of seizure-free days wasere also analyzed. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Basline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population||||||
2650475|NCT01668654|Primary|Number of Days of Exposure to Retigabine/Ezogabine TID by Individual Participant|Total number of days each participant was exposed to Retigabine/Ezogabine are recorded here.|Treatment Phase plus Taper Phase (up to 97 days)|All Subjects Population|||Days|||Number
2650476|NCT01668654|Primary|Number of Participants With Sexual Maturation Based on the Tanner Stage I to Stage V of Puberty in Participants <=18 Years Old Throughout the Study|The number of participants who advanced a stage between the eligibility visit and the EW Visit was recorded. Tanner stage I is defined as no pubic hair at all (prepubertal Dominic state); stage II is defined as a small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum (males) or on the labia majora (females); stage III is defined as when the hair becomes more coarse and curly, and begins to extend laterally; stage IV is defined as adult-like hair quality, extending across pubis but sparing medial thighs; and stage V is defined as when the: hair extends to medial surface of the thighs. The investigator assessed the participant's sexual development in participants <18 years old based on the Tanner Stages of Puberty.|Eligibility Assessment (Visit 1) and EW Visit|All Subjects Population|||Participants|||Number
2650477|NCT01668654|Primary|Changes From Baseline in Learning as Measured by the Wide Range Assessment of Memory and Learning , 2nd Edition (WRAML2) at the Indicated Time Points|The WRAML2 is a standardized test that measures an individual's memory functioning. It evaluates both visual and verbal, immediate and delayed memory ability along with the acquisition of new learning. The WRAML2 core battery is composed of two verbal, two visual, and two attention concentration subtests, yielding a verbal memory index, a visual memory index and an attention-concentration index. Together, these tests yield the general memory index. The administration time is approximately 40 minutes. During the study, this test was administered if the participant was within the age range (i.e. >9 years). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). The parent study did not measure Baseline cognition, behavior, and learning so changes from Baseline were not available for participants in this study.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population||||||
2650478|NCT01668654|Primary|Changes From Baseline in Behaviour as Measured by the Child Behavior Checklist (CBCL) at the Indicated Time Points|The CBCL is a widely used parent report questionnaire identifying behavioural and emotional problems in children. The checklist is comprised of a number of statements about the child's behavior, e.g. acts too young for his/her age. Responses were recorded on a likert scale: 0 = not true, 1 = somewhat or sometimes true, 2 = very true or often true. The preschool checklist contained 100 questions and the school-age checklist contained 120 questions. During the study, only the parent/caregiver completed this questionnaire while the participants were within the age range (i.e. <18 years). Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). The parent study did not measure baseline cognition, behavior, and learning so changes from baseline were not available for participants in this study.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population||||||
2650479|NCT01668654|Primary|Changes From Baseline in Cognition as Measured by the Leiter-R at the Indicated Time Points|he Leiter International Performance Scale or simply Leiter is an intelligence test for children and adolescents, with norms ranging from 2 to 20 years. For all ages, it yields an intelligence quotient (IQ) and a measure of logical ability. It is comprised of ten subtests, seven of which were relevant to the 12-18 years age group. The administration time was approximately 40 minutes. During the study, only the parent/caregiver completed this questionnaire while the participants were within the age range (i.e. <20 years). Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). The parent study did not measure baseline cognition, behavior, and learning so changes from baseline were not available for participants in this study.|Baseline, Eligibility Assessment (Visit 1) up to 178 days|All Subjects Population||||||
2650480|NCT01668654|Primary|Changes From Baseline in Bladder Volume as Assessed by the Post Void Residual (PVR) Ultrasound at the Indicated Time Points|The PVR urine test measured the amount of urine left in the bladder after urination. The PVR bladder ultrasound was performed by an urologist, a qualified technician or by an appropriately trained qualified study nurse at Visits 1, 6, and the EW Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 6, EW Visit|All Subjects Population||||||
2650481|NCT01668654|Primary|Number of Partcipants With Hematology, Chemistry and Urinalysis Parameters Outside the Normal Ranges and Pre-determined Clinically Important Ranges|Clinical laboratory assessment included hematology, chemistry and urinalysis parameters. Clinical laboratory parameters were measured at Visit 1, 4, 5, 6, 7, EW and FU Visit. Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
2650482|NCT01668654|Primary|Change From Baseline in the Red Blood Cell Count Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. The red blood cell count was measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
2650483|NCT01668654|Primary|Change From Baseline in Mean Corpuscle Hemoglobin at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Mean corpuscle hemoglobin was measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
2650484|NCT01668654|Primary|Change From Baseline in the Mean Corpuscle Volume and Mean Platelet Volume Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Mean corpuscle volume and mean platelet colume parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
2650675|NCT01667107|Secondary|Percentage of Participants Who Develop Invasive Fungal Infection|Invasive fungal infection was assessed using the Mycoses Study Group/European Organisation for Research and Treatment of Cancer (MSG/EORTC) criteria. Infections counted in the analysis were those classified as 'proven', 'probable', or 'possible' according to the criteria.|Up to Day 84|Participants were analyzed according to the group in which they were enrolled|||Percentage of participants||95% Confidence Interval|Number
2650486|NCT01668654|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Segmented Neutrophils, Total Neutrophils, and Red Cell Distribution Width (RDW) Percentages at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Basophils, eosinophils, lymphocytes, monocytes, segmented neutrophils, total neutrophils and red cell distribution width (RDW) parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
2650487|NCT01668654|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Segmented Neutrophils, Total Neutrophils, and White Blood Cell Count Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Basophils, eosinophils, lymphocytes, monocytes, platelet count, segmented neutrophils, total neutrophils (Total absolute neutrophil count- total ANC), and white blood cell count parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
2650488|NCT01668654|Primary|Change From Baseline in Thyroid Stimulating Hormone (TSH) and Urine Albumin Measurements at the Indicated Time Points|Clinical laboratory assessments included measurements of endocrine and urinalysis parameters. TSH and urine albumin parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
2650489|NCT01668654|Primary|Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Uric Acid, and Urine Creatinine Concentration Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Creatinine, direct bilirubin, indirect bilirubin, total bilirubin, uric acid, and urine creatinine concentration parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
2650490|NCT01668654|Primary|Change From Baseline in Calcium, Carbon Dioxide Content/Bicarbonate, Chloride, Cholesterol, Glucose, Magnesium, Inorganic Phosphorus, Potassium, Sodium, and Urea/BUN Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Calcium, carbon dioxide content/bicarbonate, chloride, cholesterol, glucose, magnesium, inorganic phosphorus, potassium, sodium, and urea/BUN parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
2650491|NCT01668654|Primary|Change From Baseline in the BUN/Creatinine and the Urine Albumin/Creatinine Ratios at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Blood Urea Nitrogen (BUN)/Creatinine and Urine Albumin/Creatinine were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
2650492|NCT01668654|Primary|Change From Baseline in Albumin, Total Protein, Hemoglobin, and Mean Corpuscle Hemoglobin Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Albumin, total protein, hemoglobin, and mean corpuscle hemoglobin concentration parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
2650493|NCT01668654|Primary|Change From Baseline in ALT, ALP, AST, CK, and LDH Measurements at the Indicated Time Points|Clinical laboratory assessments included hematology, chemistry and urinalysis parameters. Alanine amino transferase (ALT), alkaline phosphotase (ALP), aspartate amino transferase (AST), creatine kinase (CK), and lactate dehydrogenase (LDH) parameters were measured at Visits 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
2650494|NCT01668654|Primary|Number of Participants With Abnormal Clinically Significant ECG Findings Based on Investigator Judgment at Anytime During the Study|The 12-lead ECG was recorded in a supine position at the Eligibility Assessment Visit andthe EW Visit after having kept a participant at rest in this position for 10 minutes. Abnormal findings were analyzed as clinically significant (CS) and not clinically significant (NCS). The study investigator judged the ECG abnormailities as CS or NCS.|Eligibility Assessment and EW Visit|All Subjects Population|||Participants|||Number
2650495|NCT01668654|Primary|Change From Baseline in Electrocardiogram (ECG) at the Indicated Time Points|The 12-lead ECG was recorded in a supine position at the Eligibility Assessment Visitand the EW Visit after having kept a participant at rest in this position for 10 minutes. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), EW Visit (up to 178 days)|All Subjects Population||||||
2650496|NCT01668654|Primary|Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points|BMI is calculated as weight in kilograms (kg) divided by the square of their height in metres (m^2). BMI was measured at the following Visits: 1, 4, 5, 6, 7, EW and FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
2650497|NCT01668654|Primary|Change From Baseline in Body Weight at the Indicated Time Points|Body weight was measured without shoes and wearing light clothing at the following Visits: 1, 4, 5, 6, 7, EW and FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
2650498|NCT01668654|Primary|Change From Baseline in Body Height at Indicated Time Points|Body height was measured without shoes and wearing light clothing at the following Visits: 1, 4, 5, 6, 7, EW and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
2650499|NCT01668654|Primary|Change From Baseline in Body Temperature at the Indicated Time Points|Vital sign assessment included body temperature measurements at the following Visits: 1, 4, 5, 6, 7, EW, and the FU Visit. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
2650500|NCT01668654|Primary|Change From Baseline in Heart Rate at the Indicated Time Points|Vital sign assessment included heart rate measured at the following Visits: 1, 4, 5, 6, 7, EW, and the FU Visit after the participant was in seated position for 5 minutes. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
2650501|NCT01668654|Primary|Change From Baseline in SBP and DBP at the Indicated Time Points|Vital sign assessment included SBP and DBP measurements. SBP and DBP were measured at the following Visits: 1, 4, 5, 6, 7, EW, and the FU Visit after the participant was in seated position for 5 minutes. Change from Baseline was calculated by subtracting the Baseline value from the individual post-dose values. Baseline was the first pre-Retigabine assessment conducted in the parent study GSK113284 (NCT014945840). Because the study was terminated prematurely and the sample size is small, summary statistics were not compiled.|Baseline, Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population||||||
2650502|NCT01668654|Primary|Number of Participants With Vital Signs Outside the Pre-determined Clinically Important Findings or Outside the Normal Ranges at Any Time During the Study|Vital sign assessment included systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate and body temperature measurements. SBP, DBP and heart rate were measured at the following Visits: 1, 4, 5, 6, 7, EW and the FU Visit after the participants were in the seated position for 5 minutes.|Eligibility Assessment (Visit 1), Visit 4, Visit 5, Visit 6, Visit 7, Early Withdrawal (EW) Visit, and Follow-Up (FU) Visit (up to 178 days)|All Subjects Population|||Participants|||Number
2650503|NCT01668654|Primary|Number of Participants With AEs Leading to Withdrawal|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Please refer to the AE/SAE module for a list of non-serious AEs and SAE.|From the start of study medication until the end of the Follow-Up Visit (up to 178 days)|All Subjects Population|||Participants|||Number
2651625|NCT01660893|Primary|Completion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no).||at 15 minutes with a 3 minute window||||Participants|||Count of Participants
2650504|NCT01668654|Primary|Number of Participants (Par.) With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Please refer to the AE/SAE module for a list of non-serious AEs and SAE.|From the start of study medication until the end of Follow-Up (up to 178 days)|All Subjects Population: all participants who enrolled in the study.|||Participants|||Number
2650505|NCT01668628|Secondary|The Association Between Hydration Status and Depression and Quality of Life in Hemodialysis Patients|Quality of life was measured via scores of KDQOL SF1.3. Hydration status was measured via body composition monitor as an Overhydration (OH) value Depression was assessed using Beck depression inventory (BDI) score|Visit 1(zero month) and Visit 2 (12 months after Visit 1)|Only prevalent hemodialysis dialysis participants with complete baseline hydration status and scale scores were assessed for this Outcome Measure.|||units on a scale||Standard Deviation|Mean
2650506|NCT01668628|Secondary|The Association Between Hydration Status and Depression and Quality of Life in Peritoneal Dialysis Patients|"Hydration status is checked via BCM(body composition monitor) at Visit 1 and Visit 2 period, as a Overhydration(OH) value.~Health-related quality of life (HRQOL) is measured via scores of KDQOL SF1.3. Depression was assessed using Beck Depression Inventory (BDI) score. Visit 2 period is followed 12 months after Visit 1 period. HRQOL is assessed by three components; physical health score, mental health score and kidney disease health score.~Physical health score, mental health score and kidney disease health score are averaged scores of subscales.~The range of each score and each subscale are 0 - 100, and higher values indicate better HRQOL status.~The BDI score is a summed score of each component of BDI questionnaire, and the range is 5 to 63. Higher BDI scores are considered to represent more severe depression symptoms.~The outcome measure is the averaged scores at Visit 1 between the Normohydration group and Overhydration group."|Visit 1(zero month) and Visit 2 (12 months after Visit 1)|PD participants with OH value, HRQOL scores and BDI scores at visit 1 and visit 2 were assessed for this Outcome Measure.|||units on a scale||Standard Deviation|Mean
2650507|NCT01668628|Primary|Change of Kidney Disease Quality of Life Short Form 1.3 (KDQOL SF 1.3) Score and Beck Depression Inventory(BDI) Score From Visit 1 Period|"Health-related quality of life (HRQOL) is assessed via KDQOL SF 1.3 and depression is assessed via BDI at the visit 1 and Visit 2 period.~KDQOL SF 1.3 and BDI are validated questionnaires to assess HRQOL and depression, respectively.~Visit 2 period is followed 12 months after Visit 1 period. The outcome measure is the difference in averaged scores between Visit 1 and Visit 2; It is calculated as (Score at visit 2 - Score at visit 1).~HRQOL is assessed by three components; physical health score, mental health score and kidney disease health score.~Physical health score, mental health score and kidney disease health score are averaged scores of subscales.~The range of each score and each subscale are 0 - 100, and higher values indicate better HRQOL status.~The BDI score is a summed score of each component of BDI questionnaire, and the range is 5 to 63. Higher BDI scores are considered to represent more severe depression symptoms."|Visit 1(zero month) and Visit 2 (12 months after Visit 1)|5 subjects in Incident PD patients and 2 subjects in Prevalent HD patients are excluded due to protocol violation.|||units on a scale||Standard Deviation|Mean
2650508|NCT01668589|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 24 Months|Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).|Baseline and Month 24|Full analysis set with a baseline value and a month 24 value measured with the same machine type.|||percent change||Standard Deviation|Mean
2650509|NCT01668589|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at 24 Months|Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).|Baseline and Month 24|Full analysis set with a baseline value and a month 24 value measured with the same body side and machine type.|||percent change||Standard Deviation|Mean
2650510|NCT01668589|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at 24 Months|Bone mineral density was measured using dual energy X-ray absorptiometry (DXA).|Baseline and Month 24|Full analysis set with a baseline value and a month 24 value measured with the same machine type.|||percent change||Standard Deviation|Mean
2650511|NCT01668589|Secondary|Percentage of Participants Who Received Denosumab Injections Within the Specified Window|The percentage of participants who received 0, 1, 2, or 3 denosumab injections within the specified window (defined by the persistence definition as 6 months + 8 weeks). The number of injections that a participant took during the 2-year period after the first pre-enrolment injection, and that were given within the appropriate window from the previous injection, irrespective of when the previous injection was given. Only the first 3 post-baseline injections are considered.|24 months|Full analysis set|||percentage of participants|||Number
2650512|NCT01668589|Secondary|Time to Non-persistence With Denosumab Injection|Time to non-persistence for non-persistent patients was calculated as the time between the date of the first denosumab injection and the date of last denosumab injection received during the period where the patient was still classified as persistent, plus 6 months (183 days). Participants were considered persistent at 24 months if they received at least 4 injections, including the baseline injection, with no more than 6 months + 8 weeks apart between any 2 consecutive injections.|24 months|Full analysis set who were non-persistent at 24 months|||months||Inter-Quartile Range|Median
2650513|NCT01668589|Primary|Medication Coverage Ratio (MCR) for Denosumab Injection at 12 Months and 24 Months|"MCR at 12 months was defined as the accumulative number of days covered with denosumab treatment during the first 12 months divided by 366 days, expressed as a percentage.~MCR at 24 months was defined as the accumulative number of days covered with denosumab treatment during the first 24 months divided by 732 days, expressed as a percentage.~It was assumed that each injection of denosumab treatment provided 6 months of coverage (or 183 days) from the date of injection or until the date of the next injection, whichever comes first. So, a participant who received only 1 injection in the first year would have MCR at 12 months equal to 50%."|From baseline to 12 months and 24 months|Full analysis set|||percentage of days of coverage||95% Confidence Interval|Mean
2657975|NCT01601977|Secondary|Health Related Quality of Life|Severe Respiratory Insufficiency (SRI) questionnaire. Higher scores indicate better quality of life (minimum 0, maximum 100)|2 weeks||||units on a scale||Standard Deviation|Mean
2650514|NCT01668589|Primary|Percentage of Participants Adherent to Denosumab Injection at 12 Months and 24 Months|"A participant was considered adherent to denosumab at 12 months if they received at least 1 denosumab injection over the 12-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart).~A participant was considered adherent to denosumab at 24 months if they received at least 3 denosumab injections over the 24-month period following the pre-enrolment denosumab injection, with the time between any 2 consecutive injections being at most 6 months ± 4 weeks (between 155 and 211 days apart)."|12 months and 24 months|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2650515|NCT01668589|Primary|Percentage of Participants Persistent With Denosumab Injections at 12 Months and 24 Months|"A participant was considered persistent with denosumab at 12 months if they received at least 1 denosumab injection following the pre-enrolment denosumab injection no later than 6 months + 8 weeks (ie, no greater than 239 days apart).~A participant was considered persistent with denosumab at 24 months if they received at least 3 denosumab injections following the pre-enrolment denosumab injection, and the length of time between any 2 consecutive denosumab injections did not exceed 6 months + 8 weeks (ie, no greater than 239 days apart)."|12 months and 24 months|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2650516|NCT01668355|Other Pre-specified|Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Interpersonal Functioning|Assesses patient psychopathology in the domain of interpersonal functioning. Scores range from 0 to 4. Lower scores mean a worse outcome.|15 months|These are the number of subjects for whom data was available for this measure during the relevant time frame.|||score on a scale||Standard Deviation|Mean
2650517|NCT01668355|Other Pre-specified|Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Depression Daily Functioning|Assesses patient psychopathology in the domain of depression/daily functioning. Scores range from 0 to 4. Higher scores mean a worse outcome.|15 months|These are the number of subjects for whom data was available for this measure during the relevant time frame.|||score on a scale||Standard Deviation|Mean
2650518|NCT01668355|Other Pre-specified|Patient Psychopathology: Behavior and Symptom Identification Scale (BASIS-R) Psychosis|Assesses patient psychopathology in the domain of psychosis. Scores range from 0 to 4. Higher scores mean a worse outcome.|15 months|These are the number of subjects for whom data was available for this measure during the relevant time frame.|||score on a scale||Standard Deviation|Mean
2650519|NCT01668355|Primary|Patient Satisfaction With Care: Patient Assessment of Chronic Illness Care (ACIC/PACIC)|Assesses the patient's experience and satisfaction with receipt of chronic care. This measure aligns with the Chronic Care Model. The ACIC/PACIC ranges from from 1 to 5. Higher scores mean a better outcome.|15 months|These are the number of subjects for whom data was available for this measure during the relevant time frame.|||score on a scale||Standard Deviation|Mean
2650520|NCT01668355|Primary|Patient Satisfaction With Care: Ambulatory Care Experiences Survey (ACES; Short Form)|Evaluates patients' experiences and satisfaction with a physician's practice. The ACES uses the Institute of Medicine definition of primary care as its underlying conceptual model for measurement. The ACES range is 0 to 100. Higher scores mean a better outcome.|15 months|These are the number of subjects for whom data was available for this measure during the relevant time frame.|||score on a scale||Standard Deviation|Mean
2650521|NCT01668355|Primary|Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Mental Health|Mental health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.|15 months|These are the number of subjects for whom data was available for this measure during the relevant time frame.|||score on a scale||Standard Deviation|Mean
2650522|NCT01668355|Primary|Patient Health-related Quality of Life: Veterans RAND 6 Item Health Survey (VR-6) Physical Health|Physical health related quality of life. The scale range is 0 to 100. Higher scores mean a better outcome.|15 months|These are the number of subjects for whom data was available for this measure during the relevant time frame.|||score on a scale||Standard Deviation|Mean
2650523|NCT01668355|Primary|Provision of Appropriate Preventive and Medical Treatments|Screened for body mass index, blood pressure, lipids, and glucose or hemoglobin A1c.|15 months|These are the number of subjects for whom data was available for this measure during the relevant time frame.|||Participants|||Count of Participants
2650524|NCT01668173|Primary|Overall Objective Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 months||||participant with Stable Disease|||Number
2650525|NCT01668147|Primary|Cerebral [11C]dLop Distribution Volume||1 day|0 Participants Analyzed/Assigned. The PI has left the institution. Sincere efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.||||||
2650526|NCT01668030|Primary|Time to Wound Epithelialization|Time it required the subjects treated with two standard ointments to establish a wound bed.|Two years||||days|cheeks (side of face)||Number
2650527|NCT01668017|Secondary|Percentage of Subjects With Disease Control|Percentage of subjects with disease control (CR plus PR plus greater than 12 weeks SD) according to RECIST Version 1.1 was reported CR was defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions.|Day 1 of Cycle 3 and Day 1 of every alternate until end of treatment (up to a maximum of 35.4 weeks)|Efficacy analysis set included all subjects who received at least one administration of planned dose of pimasertib and who have had at least one efficacy assessment after the first dose.|||percentage of subjects|||Number
2650721|NCT01666782|Secondary|The Seroconversion Rate of High-dose Influenza Vaccine Versus Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Less Than 65 Years Old.|Seroconversion rate was defined as the percentage of patients with a greater than or equal to 4-fold increase in HAI titer 28 days after vaccination.|Baseline and 28 days||||percentage of participants|||Number
2650528|NCT01668017|Secondary|Percentage of Subjects With Objective Response|Percentage of subjects with objective response (CR plus PR) according to RECIST Version 1.1 was reported. CR was defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters.|Day 1 of Cycle 3 and Day 1 of every alternate until end of treatment (up to a maximum of 35.4 weeks)|Efficacy analysis set’ included all subjects who received at least one administration of planned dose of pimasertib and who have had at least one efficacy assessment after the first dose.|||percentage of subjects|||Number
2650529|NCT01668017|Secondary|Percentage of Subjects With Best Overall Response|Percentage of subjects with best overall response in each category (complete response [CR], partial response [PR], stable disease [SD], progressive disease [PD]) according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) was reported. CR was defined as disappearance of all target and all non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or unequivocal progression of existing non-target lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Day 1 of Cycle 3 and Day 1 of every alternate until end of treatment (up to a maximum of 35.4 weeks)|Efficacy analysis set included all subjects who received at least one administration of planned dose of pimasertib and who have had at least one efficacy assessment after the first dose.|||percentage of subjects|||Number
2650530|NCT01668017|Secondary|Accumulation Ratio for Cmax Racc(Cmax) of Part 1: Pimasertib 30 mg In HCC Arm|Racc (Cmax) was calculated as, maximum observed plasma concentration on Day 1 (Cmax) divided by maximum observed plasma concentration on Day 15 (Cmax).|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1 and Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||ratio|||Number
2650531|NCT01668017|Secondary|Accumulation Ratio for Cmax Racc(Cmax) of Pimasertib|"Racc (Cmax) was calculated as, maximum observed plasma concentration on Day 1 (Cmax) divided by maximum observed plasma concentration on Day 15 (Cmax). Data were not reported for Part 1: Pimasertib 45 mg In HCC arm as there were no PK samples collected for this arm."|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1 and Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2650532|NCT01668017|Secondary|Accumulation Ratio for AUC Racc(AUC) of Part 1: Pimasertib 30 mg In HCC Arm|Racc (AUC) was calculated as, area under the curve from time zero to end of dosing interval on Day 1 divided by area under the curve from time zero to end of dosing interval on Day 15.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1 and Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||ratio|||Number
2650533|NCT01668017|Secondary|Accumulation Ratio for AUC Racc(AUC) of Pimasertib|"Racc (AUC) was calculated as, area under the curve from time zero to end of dosing interval on Day 1 divided by area under the curve from time zero to end of dosing interval on Day 15. Data were not reported for Part 1: Pimasertib 45 mg In HCC arm as there were no PK samples collected for this arm."|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1 and Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2650534|NCT01668017|Secondary|Apparent Volume of Distribution at Terminal Phase (Vz/f) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||liters|||Number
2650535|NCT01668017|Secondary|Apparent Volume of Distribution at Terminal Phase (Vz/f) of Pimasertib on Cycle 1 Day 15|"Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Data were not reported for Part 1: Pimasertib 45 mg In HCC arm as there were no PK samples collected for this arm."|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||liters||Geometric Coefficient of Variation|Geometric Mean
2650536|NCT01668017|Secondary|Apparent Volume of Distribution at Terminal Phase (Vz/f) Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||liters|||Number
2650537|NCT01668017|Secondary|Apparent Volume of Distribution at Terminal Phase (Vz/f) of Pimasertib on Cycle 1 Day 1|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||liters||Geometric Coefficient of Variation|Geometric Mean
2650538|NCT01668017|Secondary|Apparent Clearance at Steady-state (CLss/f) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15|Apparent clearance at steady state was reported. Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||L/h|||Number
2650539|NCT01668017|Secondary|Apparent Clearance at Steady-state (CLss/f) of Pimasertib on Cycle 1 Day 15|"Apparent clearance at steady state was reported. Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Data were not reported for Part 1: Pimasertib 45 mg In HCC arm as there were no PK samples collected for this arm."|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2650540|NCT01668017|Secondary|Apparent Clearance (CL/f) of Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed. The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||L/h|||Number
2650541|NCT01668017|Secondary|Apparent Clearance (CL/f) of Pimasertib on Cycle 1 Day 1|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance after oral dose (CL/f) is influenced by the fraction absorbed.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||liter/hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2650542|NCT01668017|Secondary|Apparent Terminal Half-life (t1/2) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination. The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||hours|||Number
2650543|NCT01668017|Secondary|Apparent Terminal Half-life (t1/2) of Pimasertib on Cycle 1 Day 15|"The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination. Data were not reported for Part 1: Pimasertib 45 mg In HCC arm as there were no PK samples collected for this arm."|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||hours||Full Range|Median
2650544|NCT01668017|Secondary|Apparent Terminal Half-life (t1/2) of Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination. The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||hours|||Number
2650545|NCT01668017|Secondary|Apparent Terminal Half-life (t1/2) of Pimasertib on Cycle 1 Day 1|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||hours||Full Range|Median
2650546|NCT01668017|Secondary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUC0-tau) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (12 hours). The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||h*ng/mL|||Number
2652422|NCT01652703|Secondary|Percentage of Participants With an LDL-C Response at Week 12|An LDL-C response was defined as LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12. LDL-C was measured using ultracentrifugation.|Week 12|Full analysis set|||percentage of participants|||Number
2650547|NCT01668017|Secondary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUC0-tau) of Pimasertib at Cycle 1 Day 15|"Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (12 hours). Data were not reported for Part 1: Pimasertib 45 mg In HCC arm as there were no PK samples collected for this arm."|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2650548|NCT01668017|Secondary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUC0-tau) of Pimasertib of 1 Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (12 hours). The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||h*ng/mL|||Number
2650549|NCT01668017|Secondary|Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUC0-tau) of Pimasertib at Cycle 1 Day 1|Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (12 hours).|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2650550|NCT01668017|Secondary|Area Under the Concentration Over Time (AUCt) of Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||h*ng/mL|||Number
2650551|NCT01668017|Secondary|Area Under the Concentration Over Time (AUCt) at Cycle 1 Day 1||Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2650552|NCT01668017|Secondary|Time to Reach Maximum Concentration (Tmax) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15|The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||hours|||Number
2650553|NCT01668017|Secondary|Time to Reach Maximum Concentration (Tmax) on Cycle 1 Day 15|"Data were not reported for Part 1: Pimasertib 45 mg In HCC arm as there were no PK samples collected for this arm."|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||hours||Full Range|Median
2650554|NCT01668017|Secondary|Time to Reach Maximum Concentration (Tmax) of Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||hours|||Number
2650555|NCT01668017|Secondary|Time to Reach Maximum Concentration (Tmax) on Cycle 1 Day 1||Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||hours||Full Range|Median
2650556|NCT01668017|Secondary|Maximum Observed Concentration (Cmax) of Part 1: Pimasertib 30 mg in HCC Arm on Cycle 1 Day 15|The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||ng/mL|||Number
2650557|NCT01668017|Secondary|Maximum Observed Concentration (Cmax) of Pimasertib on Cycle 1 Day 15|"Data were not reported for Part 1: Pimasertib 45 mg in HCC arm as there were no PK samples collected for this arm."|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 15|PK analysis set. Here “Overall Number of Participants Analyzed” signifies the overall number of subjects who were evaluable for this outcome measure for each arm, respectively.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2650558|NCT01668017|Secondary|Maximum Observed Concentration (Cmax) of Part 1: Pimasertib 45 mg in HCC Arm on Cycle 1 Day 1|The summarized data was not available for this arm therefore individual data was presented.|Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|PK analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||ng/mL|||Number
2650559|NCT01668017|Secondary|Maximum Observed Concentration (Cmax) of Pimasertib on Cycle 1 Day 1||Cycle 1: Pre-morning dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, hours post dose, pre-evening dose (Hour 12) at Day 1|Pharmacokinetic (PK) analysis set included all subjects who received at least 1 planned dose of pimasertib and who had at least 1 measurable post-dose concentration. Subjects with important protocol deviations or events, which may impact the quality of the PK data were excluded from the PK analysis set.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2650560|NCT01668017|Secondary|Number of Subjects Who Experienced Treatment-Emergent Adverse Events (TEAEs) or Serious TEAEs|An adverse event (AE) was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline up to 30 days post last dose of study drug; assessed maximum up to 39.4 weeks|Safety analysis set included all subjects who received at least one administration of pimasertib.|||subjects|||Number
2650561|NCT01668017|Primary|Number of Subjects Who Experienced at Least One Dose Limiting Toxicity (DLT)|DLT defined using National Cancer Institute Common Toxicity Criteria for Adverse Events Version 3.0 (NCI CTCAE v3.0): any of following toxicities possibly/probably related to study drug: Any non-hematological toxicity of Grade 3 or higher (excluding Grade 3 asymptomatic rise in liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], gamma-glutamyl transferase [GGT] reversible in 7 days for subjects with solid tumor and without liver involvement, or Grade 4 for subjects with HCC or with liver involvement; Grade 3 or 4 asymptomatic rise in creatinine phosphokinase (CPK) reversible in 7 days, deniable for myocardial infarction and rhabdomyolysis; Grade 3 vomiting/diarrhea encountered without optimal therapy). Any Grade 4 neutropenia >5 days duration, any Grade 3 or above febrile neutropenia. Grade 4 thrombocytopenia >1 day or Grade 3 with bleeding. Any treatment delay >2 weeks due to drug-related adverse effects.|During Treatment Cycle 1 (Day 1 to 21)|DLT analysis set included all subjects who experienced any DLT during Cycle 1 and who received above 85% of all planned doses of pimasertib during Cycle 1.|||subjects|||Number
2650562|NCT01668004|Secondary|Percentage of Ankylosing Spondylitis Disease Activity Score (ASDAS) Responders Following Treatment With GLM|The percentage of participants with ASDAS clinically important improvement (ASDAS-CII; ≥ 1.1 units) and major improvement (ASDAS-MI; ≥ 2.0 units) at 3 months were determined. The ASDAS incorporates three items from the BASDAI (spinal pain, duration of morning stiffness, and peripheral joint pain or swelling) each assessed on a VAS (0 to 10 cm; increasing severity) as well as patient global assessment of disease activity (VAS; 0 to 10 cm; increasing severity) and a laboratory measure of inflammation (CRP level [mg/L] or ESR [mm/hr]). ASDAS was calculated using the formula: 0.12*Spinal Pain + 0.06*Duration of Morning Stiffness + 0.11*Patient Global + 0.07*Peripheral Pain/Swelling + 0.58*ln(CRP (mg/L) +1). A decrease in ASDAS at 3 months relative to BL signifies an improvement in physical function; ASDAS-MI (≥ 2.0 units decrease from BL) signifies a comparatively greater improvement in physical function than ASDAS-CII (≥ 1.1 units decrease from BL).|BL, Study Month 3|All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (ASDAS).|||Percentage of participants|||Number
2650563|NCT01668004|Secondary|Percentage of Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50) Responders Following Treatment With GLM|The percentage of participants with a BASDAI 50 response (defined as a 50% improvement or as an absolute improvement of 2 points in their BASDAI physical function score) at three months was determined. The BASDAI consists of total of six visual analog scales (VAS): five VAS (0 to 10 cm; increasing severity) measuring severity of fatigue, spinal pain, peripheral joint pain or swelling, localized tenderness, and severity of morning stiffness and one VAS (0 to 10 cm; increasing duration up to 2 hours) measuring duration of morning stiffness. The morning stiffness scores are averaged and summed with the scores for the remaining four items resulting in a composite score (0-50); the final BASDAI score (0-10) is derived by dividing by 5.|Baseline (BL), Study Month 3|All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (BASDAI 50).|||Percentage of participants|||Number
2650564|NCT01668004|Secondary|Annual Incidence Rate of New-Onset or Flares of Inflammatory Bowel Disease (IBD) and Psoriasis in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment|IBD (Crohn's disease or ulcerative colitis) and psoriaris are extra-articular manifestations of AS involving the intestinal tract and skin, respectively. The annual incidence rates of new-onset or flares of IBD and psoriasis were to be determined separately (i.e., for each condition) over two 1-year long periods: 1) the historical observation period consisting of the year before initial anti-TNF treatment (for anti-TNF experienced participants) or prior to first GLM dose (for anti-TNF naïve participants); and 2) the GLM observation period consisting of the year after first GLM dose.|Twelve Months Prior to Enrollment to Study Month 12|The incidence rates for new onset or flares of IBD and psoriasis could not be evaluated due to limitations of the data collected; occurrence of flares was not collected (specifically, history of IBD and/or psoriasis could not be distinguished from flares of IBD and/or psoriasis) and, therefore, results could not be determined.||||||
2650581|NCT01667796|Secondary|Gene Expression Microarray|We had initially planned to do whole blood gene expression. The experience gained by the laboratory that was to perform this since the original trial was planned was that this measure is too noisy and would not yield meaningful results. Thus, this analysis will no longer be conducted.|90 days|We had initially planned to do whole blood gene expression. The experience gained by the laboratory that was to perform this since the original trial was planned was that this measure is too noisy and would not yield meaningful results. Thus, this analysis will no longer be conducted.||||||
2652094|NCT01656252|Secondary|Phase I & Phase II- Pharmacokinetics of Eltrombopag|To determine the plasma concentrations of eltrombopag in acute myeloid leukemia patients in complete remission receiving intensive consolidation chemotherapy (selected dosing regimen only).|62 months|Data was not collected.||||||
2650565|NCT01668004|Primary|Annual Incidence Rate of New Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment|"Uveitis is an extra-articular manifestation of AS involving inflammation of the eye. The annual incidence rate of new uveitis attacks was determined over two 1-year long periods: 1) the historical observation period consisting of the year before initial anti-TNF treatment (for anti-TNF experienced participants) or prior to first GLM dose (for anti-TNF naïve participants); and 2) the GLM observation period consisting of the year after first GLM dose. All participants were counted as contributing a full year of GLM exposure even if discontinuing early. Due to ongoing uveitis cases at time of period entry, participants did not have the same risk of new events during the one year periods. Participants with ongoing uveitis at start of GLM who had the adverse event for the entire treatment period were counted as having the 'new attack' before and no new attack after GLM treatment start."|Twelve Months Prior to Enrollment to Study Month 12|All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (incidence of uveitis). One participant for whom the timing of uveitis events could not be determined was excluded from the analysis.|||Events per 100 participant years|||Number
2650566|NCT01668004|Primary|Occurence Rate of Uveitis Attacks in Participants Before Anti-TNF/GLM Treatment and After the Start of GLM Treatment|Uveitis is an extra-articular manifestation of ankylosing spondylitis (AS) involving inflammation of the eye. The occurrence rate (assessed as present/absent) of uveitis attacks was determined over two 1-year long periods regardless of whether the event started during the assessed year: 1) the historical observation period consisting of the year before initial anti-TNF treatment (for anti-TNF experienced participants) or prior to first GLM dose (for anti-TNF naïve participants); and 2) the GLM observation period consisting of the year after first GLM dose.|Twelve Months Prior to Enrollment to Study Month 12|All participants who received at least 3 months of GLM in the study and at least 3 months of follow-up data available for analysis of the endpoint (occurence of uveitis).|||Ratio|||Number
2650567|NCT01667978|Primary|AUC Norethindrone|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 21|following 21 days of continuous ingestion|2 withdrew because unable to present for study visit and another changed her medication|||ng*h/mL||Full Range|Mean
2650568|NCT01667926|Secondary|HDRS-28 Total|Hamilton Depression Rating Scale Total scores after completing 6 infusions. Scores may range from 0-81 with higher scores indicating greater depression severity. HDRS-28 score ≤ 7 was considered remission.|up to 5 months||||units on a scale||Standard Deviation|Mean
2650569|NCT01667926|Primary|Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI)|The HDRS-SI score consists of a single item on the Hamilton Depression Rating Scale (HDRS). Scores range from 0 to 4, with 0 representing no suicidal ideation, and 4 representing a suicide attempt.|up to 4 months||||units on a scale||Standard Deviation|Mean
2650570|NCT01667900|Secondary|Part B - Pharmacodynamics: Area Under the Plasma Glucose Time Curve From Time Zero to 4 Hours Postmeal (gAUC[0-4])|Pharmacodynamic parameters were assessed at baseline and on Days 3, 24, and 29 in Part B.|Baseline and Days 3, 24, and 29|Participants in Part B who received at least 1 dose of study drug and had evaluable gAUC(0-4) data.|||millimoles*hours per liter (mmol*h/L)||Standard Deviation|Mean
2650571|NCT01667900|Primary|Pharmacokinetics: Half-life of Dulaglutide|Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.|Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose|Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable half-life data.|||hours||Full Range|Geometric Mean
2650572|NCT01667900|Primary|Pharmacokinetics: Area Under the Concentration-time Curve From Time Zero to 336 Hours Postdose (AUC[0-336]) of Dulaglutide|Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.|Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose|Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable AUC(0-336) data.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2650573|NCT01667900|Primary|Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of Dulaglutide|Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.|Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose|Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Tmax data.|||hours||Full Range|Median
2650574|NCT01667900|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Dulaglutide|Pharmacokinetic parameters were assessed on Day 1 in Part A and Days 1 and 22 in Part B.|Pre-dose and 12, 24, 48, 72, 96, 168, and 336 hours post-dose|Participants in Part A and Part B who received at least 1 dose of study drug and had evaluable Cmax data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2650575|NCT01667848|Secondary|Core Temperature|core temperature during laparoscopic cholecystectomy using a rectal probe|during operation||||degree celsius||Standard Deviation|Mean
2650576|NCT01667848|Primary|Pain (Rated With a Visual Analog Scale for Pain)|"postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day.~The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)"|first postoperative day||||units on a scale 0-10||Standard Deviation|Mean
2650577|NCT01667848|Secondary|Core Temperature||one day postoperativly|||||||
2650578|NCT01667848|Primary|Pain (Rated With a Visual Analog Scale for Pain)|"postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day.~The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)"|operation day|||||||
2650579|NCT01667796|Secondary|Change in Percentage of B Cells|The change in percentage (day 90-baseline) was originally planned for study. Due to the limited number of patients with samples this plan was abandoned.|90 days|B Cell data were not analyzed and are no longer planned to be measured as outcomes.||||||
2650580|NCT01667796|Secondary|Change in Cytokine Levels|The original plan had been to measure the change in basic serum cytokine levels (e.g. IL-17, interferon gamma; IL-10; pg/microliter). However, due to emerging data suggesting low utility of these measures, this plan was abandoned.|90 days|Cytokine levels data were not analyzed and are no longer planned to be measured as outcomes.||||||
2650582|NCT01667796|Secondary|Change in Percentages of T Cell Subsets (IFNγ+ and IL-17+)|Analyzed the mean percentage change in IFNγ+ and IL-17+ cluster of differentiation 4 (CD4) + cells (post- versus pre- supplementation). This represents a change between two time points (90 days versus baseline).|Baseline, 90 days||||percentage of cells||Standard Deviation|Mean
2650585|NCT01667731|Secondary|Percentage of Participants Experiencing On-treatment Virologic Failure|"On-treatment virologic failure was defined as:~Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or~Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment"|Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
2650586|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 8||Baseline; Week 8|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2650587|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 6||Baseline; Week 6|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2650588|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 4||Baseline; Week 4|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2650589|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 2||Baseline; Week 2|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2650590|NCT01667731|Secondary|Change From Baseline in HCV RNA at Week 1||Baseline; Week 1|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2650591|NCT01667731|Secondary|Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
2650592|NCT01667731|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants discontinuing any study drug due to an adverse event was summarized.|Up to 24 weeks|Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug|||percentage of participants|||Number
2650593|NCT01667731|Primary|Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled and received at least 1 dose of study drug|||percentage of participants|||Number
2650594|NCT01667679|Secondary|Number of Participants With the Indicated Concomitant Medications|Concomitant medications are defined as non-study medications with a start or stop date between the first dose of study medication and the end of safety follow-up, inclusive. Derm. = dermatologic; incl. - including.|up to 24 weeks|Safety Analysis Set|||participants|||Number
2650595|NCT01667679|Secondary|Number of Participants With the Indicated Physical Examination Abnormalities at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)|The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). CS = clinically significant. CNS = clinically not significant.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set|||participants|||Number
2650596|NCT01667679|Secondary|Number of Participants With the Indicated 12-lead Electrocardiogram (ECG) Findings at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)|"The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Clinical significance was determined by the Investigator (per clinical judgement). A categorization of normal or abnormal was made per the investigators' clinical judgment of the ECG, taking the participants' demographic characteristics and other medical conditions into account. CS = clinically significant. CNS = clinically not significant."|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set|||participants|||Number
2650597|NCT01667679|Secondary|Change From Baseline in Pulse at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in pulse was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||beats per minute||Standard Deviation|Mean
2650598|NCT01667679|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in SBP and DBP was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2650599|NCT01667679|Secondary|Number of Participants With the Indicated Amounts of Protein, Glucose, Ketones, Blood, and White Blood Cells (WBCs) in Urine at Baseline, Visit 3 (up to Week 12), and Visit 4 (up to Week 24)|"The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1. Data are based on standard reads, with 1+, 2+, and 3+ indicating increasing amounts of metabolites in urine."|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set|||participants|||Number
2650600|NCT01667679|Secondary|Change From Baseline in Urinalysis Values by Dipstick Method at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in urinalysis values was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||pH||Standard Deviation|Mean
2650601|NCT01667679|Secondary|Change From Baseline in Sodium, Potassium, Chloride, Calcium, and Glucose at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in sodium, potassium, chloride, calcium, and glucose was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||mmoles/L||Standard Deviation|Mean
2650602|NCT01667679|Secondary|Change From Baseline in Albumin and Total Protein at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in albumin and total protein was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||grams per Liter (grams/L)||Standard Deviation|Mean
2650603|NCT01667679|Secondary|Change From Baseline in Total Bilirubin at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in total bilirubin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||Units per Liter (U/L)||Standard Deviation|Mean
2650604|NCT01667679|Secondary|Change From Baseline in Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in AST and GGT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||International Units per Liter (IU/L)||Standard Deviation|Mean
2650605|NCT01667679|Secondary|Change From Baseline in Alkaline Phosphatase (ALP) and Alanine Aminotransferase (ALT) at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in ALP and ALT was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||International Units per Liter (IU/L)||Standard Deviation|Mean
2650606|NCT01667679|Secondary|Change From Baseline in Creatinine at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in creatinine was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||micromoles per Liter (µmol/L)||Standard Deviation|Mean
2650607|NCT01667679|Secondary|Change From Baseline in Urea at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in urea was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||millimoles per Liter (mmol/L)||Standard Deviation|Mean
2650608|NCT01667679|Secondary|Change From Baseline in White Blood Cell Count, Basinophils, Monocytes, Neutrophils, Lymphocytes, Eosinophils, and Platelets at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in white blood cell (WBC) count, basinophils, monocytes, neutrophils, lymphocytes, eosinophils, and platelets was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||10^9 cells per Liter||Standard Deviation|Mean
2650609|NCT01667679|Secondary|Change From Baseline in Red Blood Cell Count at Visit 3 (up to Week 12) and Visit 4 (up to Week 24)|Change from Baseline in red blood cell count was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||10^12 cells per Liter||Standard Deviation|Mean
2650628|NCT01667549|Secondary|Maternal Perceptions|Mothers rated infants' enjoyment of the taste of the cereal (9-point scale); aratings range from 1 (extreme dislike) to 9 (extreme like).|6- to 10-month-old weaned infants (3 separate test days)|Some of the infants refused to eat (plain cereal: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=4; 3M0.5, N=1; carrot cereal: 1M0.5, N=2; 1M1.5, N=2; 1M2.5, N=4; 3M0.5, N=1; Broccoli: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=3; 3M0.5 , N=1) and therefore the number of maternal ratings analyzed differs from number in each group|||Score on a scale||Standard Error|Mean
2650610|NCT01667679|Secondary|Change From Baseline in Hematocrit at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)|Change from Baseline in hematocrit (proportion of total blood volume that is composed of red blood cells) was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||proportion||Standard Deviation|Mean
2650611|NCT01667679|Secondary|Change From Baseline in Hemoglobin at Visit 3 (up to 12 Weeks) and Visit 4 (up to 24 Weeks)|Change from Baseline in hemoglobin was assessed at Visit 3 (the start of Treatment Period 2) and Visit 4 (the end-of-study visit). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Baseline value is the last non-missing value prior to or on the start date of Treatment Period 1.|Baseline and Visits 3 (up to 12 weeks) and 4 (up to 24 weeks)|Safety Analysis Set. Only those participants with data available at Visit 3 and Visit 4 were assessed at that respective visit (indicated by n=X, X in the category titles).|||grams per Liter (g/L)||Standard Deviation|Mean
2650612|NCT01667679|Secondary|Number of Participants With Any Treatment-emergent Non-serious and Serious Adverse Event|An adverse event is defined as any untoward medical occurrence associated with the use of an investigational product in humans, whether or not it is considered related to the investigational product. This includes any occurrence that was new in onset or aggravated in severity or frequency from the Baseline condition.|Baseline compared to Vist 2, 3 and 4|Safety Analysis Set: all randomized participants who received at least 1 dose of either 20 mg sumatriptan nasal powder or 100 mg sumatriptan tablet|||participants|||Number
2650613|NCT01667679|Secondary|Mean Change From Baseline in Clinical Disability Score at 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose|Participants were required to record their clinical disability score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their disability on the following scale: 0, no disability, able to function normally; 1, performance of daily activities mildly impaired, can still do everything but with difficulty; 2, performance of daily activities moderately impaired, unable to do some things; 3, performance of daily activities severely impaired, cannot do all or most things, bed rest may be necessary. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)|FAS. The LOCF imputation method was used for this analysis. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect.|||scores on a scale||Standard Error|Least Squares Mean
2650614|NCT01667679|Secondary|Mean Change in Headache Severity From Baseline to 10, 15, 30, 45, 60, 90, and 120 Minutes Post-dose|Participants were required to record their headache severity score in their e-diaries immediately before intake of study medication (Baseline) and at 10, 15, 30, 45, 60, 90, and 120 minutes post-dose. Participants graded their headaches on the following severity scale: 0, none; 1, mild; 2, moderate; 3, severe. Mean change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)|FAS. The LOCF imputation method was used for this analysis. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect.|||scores on a scale||Standard Error|Least Squares Mean
2650615|NCT01667679|Secondary|Median Time to Pain Freedom|Pain freedom is defined as a pain level reduced to none (Grade 0).|120 minutes post-dose (up to 24 weeks)|FAS. If the participant did not report pain freedom within 120 minutes post-dose, he/she was considered to be censored at the last non-missing result prior to the 120-minute time point.|||minutes||95% Confidence Interval|Median
2650616|NCT01667679|Secondary|Percentage of Attacks in Which Pain Relief Was Achieved|Percentage of attacks treated at a severity of moderate (Grade 2) or severe (Grade 3) in which pain relief (defined as pain level reduced to none [Grade 0] or mild [Grade 1]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.|Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)|FAS. The LOCF imputation method was used in this analysis.|||percentage of attacks|number of moderate or severe attacks||Number
2650617|NCT01667679|Secondary|Percentage of Attacks in Which Pain Freedom Was Achieved|Percentage of attacks in which pain freedom (defined as pain level reduced to none [Grade 0]) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.|Baseline and 10, 15, 30, 45, 60, 90, and 120 minutes post-dose (up to 24 weeks)|FAS. The LOCF imputation method was used for this analysis.|||percentage of attacks|number of attacks||Number
2650618|NCT01667679|Secondary|Percentage of Attacks in Which Pain Reduction Was Achieved|Percentage of attacks in which pain reduction (defined as a decrease in pain intensity of at least one point on the following scale: 0, none; 1, mild; 2, moderate; 3, severe) was achieved at 10, 15, 30, 45, 60, 90, and 120 minutes after the initial dose for all attacks.|10, 15, 30, 45, 60, 90, and 120 minutes|FAS. The LOCF imputation method was used in this analysis.|||percentage of attacks|number of attacks||Number
2650619|NCT01667679|Secondary|Mean Sum of Migraine Pain Intensity Differences (SPID)-30 for Headaches With a Baseline Intensity of Mild and Moderate/Severe|"SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild and moderate/severe (rated on a 4-point scale: 0=none, 1=mild, 2=moderate, and 3=severe). The range of possible scores for all participants is -60 to +90. For participants with a mild headache at Baseline, the SPID range is -60 to +30. For participants with a moderate/severe headache at Baseline, the SPID range is -30 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of 0 indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an ANCOVA model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The LOCF imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis."|Baseline and 30 minutes post-dose (up to 24 weeks)|FAS. Only those participants with the type of attack specified were analyzed (specified by n=X, X in the corresponding category title). A single participant could have had both a mild and a moderate/severe attack.|||scores on a scale||Standard Error|Least Squares Mean
2650620|NCT01667679|Primary|Mean Sum of Migraine Pain Intensity Differences (SPID)-30|"SPID-30 is defined as the sum of the pain intensity differences (measured as area under the curve) from dosing (Baseline) through 30 minutes post-dose for headaches with a Baseline intensity of mild, moderate, or severe. The range of possible scores is -60 to +90. A higher number indicates a greater reduction in pain intensity. Negative values indicate worsening pain. A value of 0 indicates that there was no change in pain intensity from Baseline through 30 minutes. Results are from an analysis of covariance (ANCOVA) model with treatment, period, and treatment sequence as fixed effects and participant as a random effect. The Last Observation Carried Forward (LOCF) imputation method (missing values were replaced by carrying forward the preceding value) was used for this analysis."|Baseline and 30 minutes post-dose (up to 24 weeks)|Full Analysis Set (FAS): all participants who experienced at least 1 headache attack per treatment period, received at least 1 dose of study medication (sumatriptan nasal powder or tablet) in each treatment period, and had at least 1 post-Baseline assessment for a treated attack in each treatment period.|||scores on a scale||Standard Error|Least Squares Mean
2650621|NCT01667562|Secondary|Change From Baseline to End of Study in Quality of Life Score Using The Functional Assessment of Cancer Therapy Lung (FACT-L)|The domains in the Quality of life score using the Functional Assessment of Cancer Therapy Lung (FACT-L) include physical, social/family, emotional, and functional well-being, and a lung cancer subscale include symptoms, cognitive function and regret of smoking. Minimum and maximum value of the scale is 0 and 4, respectively. Higher score indicate better health state.|Baseline and end of study (approximately 4 years and 9 months)|Participants without disease progression who filled out the FACT-L questionnaire.|||unit on a scale||Standard Deviation|Mean
2650622|NCT01667562|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline up to approximately 4 years and 9 months|The safety population was identical to the ITT population, which included all participants enrolled in the study.|||percentage of participants|||Number
2650623|NCT01667562|Secondary|Proportion of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations|Mutations in the EGFR included exon 19 deletion mutations and the single-point substitution mutation L858R in exon 21.|Screening up to approximately 7 days|This study had 2 phases: 1st phase – included 375 patients assessed for EGFR mutations 30 patients (out of these 375) had EGFR mutations and they were included in 2nd phase – treatment with Erlotinib.|||proportion of participants||95% Confidence Interval|Number
2650624|NCT01667562|Secondary|Proportion of Participants With Disease Control as Assessed by RECIST v 1.1|Disease control was defined as objective response or stable disease (SD) for at least 6 weeks. OR was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of CR and PR four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)|The intent-to-treat population included all participants enrolled in the study. There were no patients excluded from analysis either in efficacy and safety analysis.|||proportion of participants||95% Confidence Interval|Number
2650625|NCT01667562|Secondary|Proportion of Participants With Objective Response as Assessed by RECIST v 1.1|Objective response (OR) was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of complete response (CR) and partial response (PR) four at least 4 weeks during treatment. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.|Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)|The intent-to-treat population included all participants enrolled in the study. There were no patients excluded from analysis either in efficacy and safety analysis.|||proportion of participants||95% Confidence Interval|Number
2650626|NCT01667562|Primary|Progression-Free Survival as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1)|Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease [PD]) based on RECIST tumor response criteria or died from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Patients who had not died or progressed at the time of the final analysis were censored at the date of last contact.|Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)|The intent-to-treat population included all participants enrolled in the study. There were no patients excluded from analysis either in efficacy and safety analysis.|||months||95% Confidence Interval|Median
2650627|NCT01667549|Secondary|Growth of Infants|At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length z-scores (WLZ) using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean or median value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).|Once a month from ages 0.5 - 4.5 months, 10.5 months|Number of infants who were weighted and measured to determine Weight for Length Z scores (WLZ) during trial; some dyads did not complete the trial so number of participants analyzed does not always match number enrolled.|||Z score||Standard Error|Mean
2650652|NCT01667432|Primary|In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive||approximately 3 years|||||||
2650653|NCT01667432|Secondary|Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio||approximately 3 years|||||||
2650629|NCT01667549|Primary|Vegetable Flavor Acceptance (Infants' Rate of Feeding)|Taste testing conducted on infants to determine acceptance of plain cereal, carrot-flavor cereal (exposed flavor for intervention groups) and broccoli-flavored cereal (novel flavor for all groups) after weaning, which occurred at ~ 8 months of age. Outcomes included intake rate of feeding (grams per minute) .|6- to 10-month-old weaned infants (3 separate test days)|Some of the infants refused to eat (plain cereal: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=4; 3M0.5, N=1; carrot cereal: 1M0.5, N=2; 1M1.5, N=2; 1M2.5, N=4; 3M0.5, N=1; Broccoli: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=3; 3M0.5 , N=1) and therefore the number participants analyzed differs from number in each group.|||grams per minute||Standard Error|Mean
2650630|NCT01667549|Primary|Taste Liking Ratings of Vegetable Flavors [Mothers].|Psychophysical testing conducted on mothers to rate their taste of carrot, beet, celery, mixed vegetable (exposed flavors for intervention groups) and apple juices using the hedonic gLMS (hedonic general labelled magnitude scale). Ratings on the scale range from -100 (strongest imaginable dislike) to 0 (neutral) to 100 (strongest imaginable like).|Monthly, 0.5 to 4.5 months|Two mothers did not complete the ratings on one test date.|||units on a scale||Standard Error|Mean
2650631|NCT01667549|Primary|Vegetable Flavor Acceptance [Infants' Intake]|Taste testing conducted on infants to determine acceptance of plain cereal, carrot-flavor cereal (exposed flavor for intervention groups) and broccoli-flavored cereal (novel flavor for all groups) after weaning, which occurred at ~ 8 months of age. Outcomes included intake (in grams).|6- to 10-month-old weaned infants (3 separate test days )|Some of the infants refused to eat (plain cereal: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=4; 3M0.5, N=1; carrot cereal: 1M0.5, N=2; 1M1.5, N=2; 1M2.5, N=4; 3M0.5, N=1; Broccoli: 1M0.5, N=1; 1M1.5, N=1; 1M2.5, N=3; 3M0.5 , N=1) and therefore the number participants analyzed differs from number in each group|||intake in grams||Standard Error|Mean
2650632|NCT01667536|Secondary|Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Metastatic Prostate Cancer Within Pelvic Lymph Nodes.|Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the lymph nodes. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.|Within 3-6 hours of dosing SPECT/CT images will be taken|All subjects who completed lymph node SPECT/CT MIP-1404 and MRI imaging, underwent EPLND, and had histopathology results.|||% sensitivity|||Number
2650633|NCT01667536|Secondary|Assess the Comparative Performance of MIP-1404 Against MRI for Detection of Prostate Cancer Within the Prostate Gland.|Comparative performance characteristics between MIP-1404 imaging and MRI were analyzed for the prostate gland. MIP-1404 and MRI sensitivities were derived from case positive histopathology results.|Within 3-6 hours of dosing SPECT/CT images will be taken|All subjects who completed prostate SPECT/CT MIP-1404 and MRI imaging and had histopathology results.|||% specificity|||Number
2650634|NCT01667536|Secondary|Assess the Ability of MIP-1404 to Detect the Specific Location of Metastatic Prostate Cancer Within Anatomic Pelvic Lymph Node Regions|"For specific segments of the lymph nodes, a sensitivity value refers to the number of evaluable segments (histologically examined tissue-segments) from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique."|Within 3-6 hours of dosing SPECT/CT images will be taken|The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)|||% sensitivity|Lymph Node Segments|90% Confidence Interval|Number
2650635|NCT01667536|Secondary|Assess the Ability of MIP-1404 to Detect the Extent and Location of Prostate Cancer Within the Prostate Gland|"For specific segments of the prostate, a sensitivity value refers to the number of evaluable segments (histologically examined tissue-segments) from all subjects, i.e., the percentages of true positive segments correctly identified by the imaging technique."|Within 3-6 hours of dosing SPECT/CT images will be taken|The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)|||% sensitivity|Prostate Segments|90% Confidence Interval|Number
2650636|NCT01667536|Secondary|Assess the Ability of MIP-1404 to Detect Metastatic Prostate Cancer Within Pelvic Lymph Nodes|For lymph nodes, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.|Within 3-6 hours of dosing SPECT/CT images will be taken|The primary analysis population, defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results, was used for this endpoint. A total of 3025 nodes were removed from 103 subjects (mean 29.6, range 1-88). Of these, 79 nodes were positive by pathology in 33 subjects.|||% sensitivity||90% Confidence Interval|Number
2650637|NCT01667536|Primary|Assess the Ability of 99mTc-MIP-1404 to Detect Prostate Cancer Within the Prostate Gland.|For the prostate gland, sensitivity values refer to the number of subjects in the study, i.e., the percentages of true positive subjects correctly identified by the imaging technique. Pathology results were used as the truth standard for all imaging analyses.|Within 3-6 hours of dosing SPECT/CT images will be taken|The primary analysis population is defined as all subjects who completed prostate and lymph node SPECT/CT MIP-1404 imaging, underwent EPLND, and had histopathology results. This population is one less than the safety population (n=105)|||% sensitivity||90% Confidence Interval|Number
2650638|NCT01667471|Secondary|CRP Levels|CRP an acute phase protein, is a marker of inflammation. CRP was measured as milligrams per deciliter (mg/dL).|Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.|||mg/dL||Standard Deviation|Mean
2650639|NCT01667471|Secondary|Parent or Participant's Assessment of Pain (VAS)|Parents or participants rated participant's pain by placing a horizontal line on a VAS of 0 (no pain)- 100 mm (severe pain).|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.|||mm||Standard Deviation|Mean
2650654|NCT01667432|Secondary|Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients||approximately 3 years|||||||
2650655|NCT01667432|Secondary|Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients||approximately 3 years|||||||
2650656|NCT01667432|Secondary|HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative||approximately 3 years|||||||
2650640|NCT01667471|Secondary|CHAQ-DI Score|The CHAQ-DI questionnaire consisted of 30 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain had at least two component questions and if applicable to the participant there were four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do). The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst).|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72, and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.|||score on a scale||Standard Deviation|Mean
2650641|NCT01667471|Secondary|Erythrocyte Sedimentation Rate|ESR is a marker of inflammation and was measured as millimeters per hour (mm/h). Healthy individuals have low ESR. Higher ESR indicate inflammation.|Baseline, Weeks 4, 8,12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.|||mm/h||Standard Deviation|Mean
2650642|NCT01667471|Secondary|Number of Joints With Lack of Motion|Joints with lack of movement were assessed. The maximum number of joints with lack of movement was 67. The joint assessment was performed by an independent assessor who was not the treating physician and who was blinded to all other aspects of the participant's efficacy and safety data.|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.|||joints||Standard Deviation|Mean
2650643|NCT01667471|Secondary|Number of Joints With Active Arthritis|Joints with active arthritis were defined as joints with swelling or pain and limited of motion. The maximum number of joints with active arthritis was 71.The joint assessment was performed by an independent assessor who was not the treating physician and who was blinded to all other aspects of the participant's efficacy and safety data.|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.|||joints||Standard Deviation|Mean
2650644|NCT01667471|Secondary|Parent or Participant's Assessment of Global Activity (VAS)|The participant or parent/guardian, as appropriate, provided a rating of the participant's well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line Score 0 represented 'very well' (ie, symptom-free and no arthritis disease activity) and the extreme right end score 100 represented 'very poor' (ie, maximum arthritis disease activity). A higher score indicated poorer well-being.|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.|||mm||Standard Deviation|Mean
2650645|NCT01667471|Secondary|Physicians Assessment of Global Activity (VAS)|The participant's treating physician provided a rating of the participant's arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line, score 0 represented 'arthritis inactive' (ie, symptom-free and no arthritis symptoms) and the extreme right end score 100 represented 'arthritis very active'. A higher score indicated more disease activity.|Baseline, Weeks 12, 24, 28, 32, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed at the specified visit.|||mm||Standard Deviation|Mean
2650646|NCT01667471|Secondary|Percentage of Participants Achieving Clinical Remission (CR) at Each Visit|"CR was defined as clinical remission with medication (CRem). A participant was in CR if inactive disease was observed for a minimum of 6 consecutive months."|Baseline, Screening, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed for the given parameter at the specified visit.|||percentage of participants|||Number
2650647|NCT01667471|Secondary|Percentage of Participants With Inactive Disease by Visit|A participant was defined to show inactive disease if all of the following criteria were applied: 1) No joints with active arthritis (no joints with swelling and no joints with lack of motion), 2) No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA, 3) No active uveitis, 4) ESR and/or CRP within normal range, and 5) Physician's global assessment of disease activity equals (=) 0 millimeters (mm) on a Visual analog scale (VAS).|Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; n = number of participants analyzed for the given parameter at the specified visit.|||percentage of participants|||Number
2650648|NCT01667471|Primary|Number of AEs of Special Interest and Study Drug Related AEs|AEs and SAEs were recorded from the first day of tocilizumab administration until 4 weeks after administration of the last dose of tocilizumab.|Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set|||adverse events|||Number
2650649|NCT01667471|Secondary|Percentage of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90 by Visit|"The six JIA ACR components comprised of: 1) Physician's global assessment of disease activity, 2) Parent/Participant's global assessment of overall well-being, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate (ESR) and/or C-reactive Protein (CRP), and 6) Childhood Health Assessment Questionnaire - Disease Index (CHAQ-DI).~At an assessment visit, a JIA ACR30/50/70/90 response in comparison to Baseline was defined as: At least three of the six JIA ACR core components improving by at least 30 percent (%), 50%, 70%, or 90% respectively and no more than one of the remaining JIA ACR core components worsening by more than 30%."|Baseline, Weeks 12, 24, 36, 48, 60, 72 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set; number (n) = number of participants analyzed for the given parameter at the specified visit.|||percentage of participants|||Number
2650650|NCT01667471|Primary|Number of Participants With Adverse Events of Special Interest and Study-Drug Related Adverse Events|Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the first day of tocilizumab administration until 4 weeks after administration of the last dose of tocilizumab. AEs of special interest were Infections (including all opportunistic infections and non-serious infections as defined by those treated with IV anti-infectives), Myocardial infarction/Acute coronary syndrome, Gastrointestinal perforations and related events, Malignancies, Anaphylaxis/Hypersensitivity reactions, Demyelinating disorders, Stroke. Bleeding events, Hepatic events and Macrophage activation syndrome (MAS).|Baseline and every 4 weeks up to Week 76 and Final Follow-Up Visit (up to 82 weeks)|Safety Analysis Set|||participants|||Number
2650651|NCT01667432|Secondary|Safety: Incidence of Adverse Events||approximately 3 years|||||||
2650657|NCT01667432|Secondary|Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment|Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative.|At the end of treatment (Week 24)|Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a. Only participants with available HBsAg measurements were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2650658|NCT01667432|Primary|Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml||approximately 3 years|||||||
2650659|NCT01667432|Primary|Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study|Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml).|At the end of the study (Week 36)|Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.|||Percentage of participants||95% Confidence Interval|Number
2650660|NCT01667419|Secondary|Plasma Concentration of Vemurafenib||Pre-morning dose (0 hour [hr]) and 1 to 4 hrs post-dose on Days 1, 8, 15, and 22 of Cycle 1; pre-morning dose (0 hr) on Days 1 and 15 of Cycle 2; pre-morning dose (0 hr) on Day 1 of Cycles 3-13; at end of treatment (up to 13 months)|The pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of vemurafenib and had provided valid PK assessments.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2650661|NCT01667419|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score|European Organisation for Research and Treatment of Cancer 30-Item Quality of Life Questionnaire assesses 8 symptoms, function, financial difficulties, and a global health status/health-related quality of life (HRQoL). Most questions use a 4-point scale (1 'Not at all' to 4 'Very much';2 questions use a 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to a 0-100 scale. Higher scores for the function and HRQoL represent higher levels of functioning and HRQoL, higher scores for the symptom represent higher levels of symptoms/problems, higher score for financial difficulty represent higher level of perceived financial burden of treatment. Changes of 5-10 points are considered to represent a minimally important difference to participants. A positive value means an increase, and negative value means a decrease in score at the indicated time-point relative to the score at baseline (Cycle 1 Day 1).|Day 1, Day 8, Day 15, Day 22 of Cycle 1;Day 1, Day 15 of Cycle 2;Day 1 Cycles 3-13;end of treatment(up to 13 months);every 13 weeks thereafter until recurrence or occurrence of a new primary melanoma (up to 17-Apr-17 data cut-off,approximately 4.5 years)|The patient-reported outcome (PRO)-evaluable population included all participants who received at least one dose of vemurafenib and who had both a baseline assessment and at least one post-baseline QLQ-C30 assessment that generated a score.|||score on a scale||Standard Deviation|Mean
2650662|NCT01667419|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.|From randomization up to study completion or discontinuation (up until 13-July-2018, approximately 6 years)|The safety population included all participants who received at least one dose of study medication.|||percentage of participants|||Number
2650663|NCT01667419|Secondary|Overall Survival (OS)|OS is defined as the time from randomization until the date of death from any cause.|From randomization until the date of death from any cause (up until 13-July-2018, approximately 6 years)|The ITT population included all participants enrolled in the study, whether or not they had received study medication.|||months||95% Confidence Interval|Median
2650664|NCT01667419|Secondary|Distant Metastasis-Free Survival (DMFS) as Assessed Using Contrast-Enhanced MRI or Contrast Enhanced CT|DMFS was defined as the time from randomization until the date of diagnosis of distant (i.e. non-locoregional) metastases or death from any cause.|From randomization until the date of diagnosis of distant (i.e., non-locoregional) metastases or death from any cause (up to the April 17, 2017 data cut-off, approximately 4.5 years)|The ITT population included all participants enrolled in the study, whether or not they had received study medication.|||months||95% Confidence Interval|Median
2650665|NCT01667419|Primary|Disease-Free Survival (DFS) as Assessed Using Contrast-Enhanced Magnetic Resonance Imaging (MRI) or Contrast Enhanced Computed Tomography (CT)|DFS was defined as the time from randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause.|From randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause (up to the April 17, 2017 data cut-off, approximately 4.5 years)|The ITT population included all participants enrolled in the study, whether or not they had received study medication.|||months||95% Confidence Interval|Median
2650666|NCT01667250|Secondary|Mean Change in Quality of Life Short Form Survey (SF-12)|"The Quality of Life Short Form Survey (SF-12) is a multipurpose short form survey with 12 questions that are combined, scored and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of the twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.~SF-12 were recorded in the subject diary at the Phase 1 follow-up visit (week 4) and during Phase 2 randomized period at week 4 and week 8."|Run-in (4 weeks) and Randomized period (8 weeks)|Randomized period|||Score on a scale||Standard Deviation|Mean
2650667|NCT01667250|Secondary|Use of Pain Relief Medication|All abortive headache medication taken during randomized period|Randomized period - 8 weeks|Randomized population|||Participants|||Count of Participants
2650668|NCT01667250|Secondary|Total Number of Headache Days Per Arm With Peak Severity of Mild, Moderate, or Severe|Peak severity per headache day was reported each headache day in the subject diary. Pain was reported as mild, moderate or severe. Whereas as mild = least severe and severe = most severe.|Run-in (4 weeks no treatment) and Randomized (8 weeks)|Randomized population|||Headache days|||Number
2652095|NCT01656252|Primary|Phase II- Assess if Platelet Count Recovery is Increased With Eltrombopag|To determine if platelet recovery following consolidation chemotherapy is accelerated with eltrombopag.|62 months|||||||
2650676|NCT01667107|Primary|Concentration of Posaconazole in Bronchoalveolar Lavage (BAL) and Serum|Concurrent BAL and serum samples for measurement of posaconazole concentration were to be collected during any clinically-indicated bronchoscopy. A participant could have more than 1 bronchoscopy.|Up to Day 42|The population analyzed included all enrolled participants who had BAL and serum samples collected at the time of bronchoscopy and analyzed for posaconazole concentration. A participant could have more than 1 pair of samples (BAL and serum) included in the analysis.|||mg/L|paired BAL and serum samples|Standard Deviation|Mean
2650677|NCT01667107|Post-Hoc|Time to Maximum Serum Concentration of Posaconazole (Tmax)|Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The time required to achieve the maximum serum concentration of posaconazole was recorded.|Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43|The population analyzed included all enrolled participants|||Days||Standard Deviation|Mean
2650678|NCT01667107|Post-Hoc|Maximum Serum Concentration of Posaconazole (Cmax)|Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The maximum serum concentration of posaconazole was recorded.|Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43|The population analyzed included all enrolled participants|||mg/L||Standard Deviation|Mean
2650679|NCT01667107|Post-Hoc|Time to Reach a Serum Concentration of Posaconazole of >=0.5 mg/L|Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. A posaconazole concentration >=0.5 mg/L is the therapeutic level, the concentration thought to lead to antifungal efficacy. The time at which the serum posaconazole concentration reached >=0.5 mg/mL and remained at that level for all subsequent assessments was recorded.|Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43|The population analyzed included all enrolled participants who reached and maintained posaconazole concentration of >=0.5 mg/L|||Days||Standard Deviation|Mean
2650680|NCT01667107|Primary|Time to Reach 90% of the Steady State Serum Concentration of Posaconazole|Blood samples for measurement of serum posaconazole were collected approximately 4 hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43. The time to reach 90% of the steady state serum posaconazole concentration was to be estimated from fitting a linear model to the concentration data over time. The data did not permit estimation of the endpoint from the modeling proposed in the protocol.|Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43|The population to be analyzed included participants who complied with the protocol sufficiently to ensure that the results would exhibit the effects of treatment||||||
2650681|NCT01667029|Secondary|Missed Medication Doses (Using the Crossover Comparison Structure of the Study)|Number of missed medication doses|Assessed during two week treatment period|8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.|||doses||Standard Deviation|Mean
2650682|NCT01667029|Secondary|Missed Medication Dose (First Treatment Period Only)|Number of missed medication doses|Assessed during two week treatment period||||dose||Standard Deviation|Mean
2650683|NCT01667029|Secondary|Breakthrough Treatment (Using the Crossover Comparison Structure of the Study)|Number of days breakthrough pain medication was taken|Assessed during two week treatment period|8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.|||days||Standard Deviation|Mean
2650684|NCT01667029|Secondary|Breakthrough Treatment (First Treatment Period Only)|Number of days breakthrough pain medication was taken|Assessed during two week treatment period||||days||Standard Deviation|Mean
2650685|NCT01667029|Secondary|Categorical Rating of Pain Intensity (Using the Crossover Comparison Structure of the Study)|Assessed using number of days rated as none, mild, moderate, or severe in pain diary|Assessed at end of two week treatment period|8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1. One participant did not complete the categorical pain data in either period.|||days||Standard Deviation|Mean
2650686|NCT01667029|Secondary|Categorical Rating of Pain Intensity (First Treatment Period Only)|Assessed using number of days rated as none, mild, moderate, or severe in pain diary|Assessed at end of two week treatment period|One participant in the sulfasalazine arm did not complete the categorical pain data.|||days||Standard Deviation|Mean
2650687|NCT01667029|Secondary|Overall Improvement (Using the Crossover Comparison Structure of the Study)|The Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. Item 1 is as follows: Since beginning treatment at this clinic, how would you describe the change (if any) in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, related to your painful condition? (tick ONE box) (1=No change (or condition has gotten worse), 2=Almost the same, hardly any change at all, 3=A little better, but no noticeable change, 4=Somewhat better, but the change has not made any real difference, 5=Moderately better, and a slight but noticeable change, 6=Better, and a definite improvement that has made a real and worthwhile difference, 7=A great deal better, and a considerable improvement that has made all the difference). Item 2 is as follows: In a similar way, please circle the number below that matches your degree of change since beginning care at this clinic (0-10 scale): 0= Much better, 5= No change, 10= Much worse.|Will be assessed at end of two week treatment period|8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1. 2 of the sulfasalzine participants are missing PGIC.|||units on a scale||Standard Deviation|Mean
2650700|NCT01666951|Other Pre-specified|Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 28.|"At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, nighttime dipping) between the two Groups at Days 28."|28 days|18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.|||ratio||Standard Deviation|Mean
2650688|NCT01667029|Secondary|Overall Improvement (First Treatment Period Only)|The Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. Item 1 is as follows: Since beginning treatment at this clinic, how would you describe the change (if any) in ACTIVITY LIMITATIONS, SYMPTOMS, EMOTIONS, and OVERALL QUALITY OF LIFE, related to your painful condition? (tick ONE box) (1=No change (or condition has gotten worse), 2=Almost the same, hardly any change at all, 3=A little better, but no noticeable change, 4=Somewhat better, but the change has not made any real difference, 5=Moderately better, and a slight but noticeable change, 6=Better, and a definite improvement that has made a real and worthwhile difference, 7=A great deal better, and a considerable improvement that has made all the difference). Item 2 is as follows: In a similar way, please circle the number below that matches your degree of change since beginning care at this clinic (0-10 scale): 0= Much better, 5= No change, 10= Much worse.|Will be assessed at end of two week treatment period|2 participants in the sulfasalazine group are missing PGIC information.|||units on a scale||Standard Deviation|Mean
2650689|NCT01667029|Secondary|Emotional Functioning (Using the Crossover Comparison Structure of the Study)|Will be assessed by the Beck Depression Inventory (BDI) total score. The BDI has 21 items, each scored 0-3. Higher values are worse. The total score is the sum of the 21 items and ranges from 0-63.|Assessed at end of two week treatment period|8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.|||units on a scale||Standard Deviation|Mean
2650690|NCT01667029|Secondary|Emotional Functioning (First Treatment Period Only)|Will be assessed by the Beck Depression Inventory (BDI) total score. The BDI has 21 items, each scored 0-3. Higher values are worse. The total score is the sum of the 21 items and ranges from 0-63.|Assessed at end of two week treatment period||||units on a scale||Standard Deviation|Mean
2650691|NCT01667029|Secondary|Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) (Using the Crossover Comparison Structure of the Study)|The EQ-5D physical functioning items are mobility self-care, and usual activities. These three items are rated from 1 (no problems) to 5 (unable).|Assessed at end of two week treatment period|8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.|||Participants|||Count of Participants
2650692|NCT01667029|Secondary|Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (Using the Crossover Comparison Structure of the Study)|The BPI interference items are general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. The seven items are rated from 0 (pain does not interfere) to 10 (pain completely interferes).|Assessed at end of two week treatment period|8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1|||units on a scale||Standard Deviation|Mean
2650693|NCT01667029|Secondary|Physical Functioning Score Assessed Using the Euroquality of Life (EQ-5D) Metrics (First Treatment Period Only)|The EQ-5D physical functioning items are mobility self-care, and usual activities. These three items are rated from 1 (no problems) to 5 (unable).|Assessed at end of two week treatment period||||Participants|||Count of Participants
2650694|NCT01667029|Secondary|Physical Functioning Score Assessed Using the Brief Pain Inventory (BPI) Interference Scale (First Treatment Period Only)|The BPI interference items are general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. The seven items are rated from 0 (pain does not interfere) to 10 (pain completely interferes).|Assessed at end of two week treatment period||||units on a scale||Standard Deviation|Mean
2650695|NCT01667029|Secondary|Number of Patients With >=50% Pain Reduction (Using the Crossover Comparison Structure of the Study)|Average pain score will be the average of daily pain scores (0-10) recorded by the subject in a pain diary during baseline and the second week of each of the two week treatment periods. Higher scores are worse (0=no pain, 10=pain as bad as you can imagine). Percent pain reduction will be calculated from BL to end of treatment period 1 (2 weeks) and from end of treatment period 1 to end of treatment period 2 (2 weeks), based on average pain scores at each time point.|Assessed at end of two week treatment period|8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.|||Participants|||Count of Participants
2650696|NCT01667029|Secondary|Number of Patients With >=50% Pain Reduction (First Treatment Period)|Average pain score will be the average of daily pain scores (0-10) recorded by the subject in a pain diary at baseline and during the second week of the two week treatment period. Higher scores are worse (0=no pain, 10=pain as bad as you can imagine). Percent pain reduction will be calculated from BL to end of treatment period 1 (2 weeks), based on average pain scores at each time point.|second week of two week treatment period||||Participants|||Count of Participants
2650697|NCT01667029|Secondary|Pain Score (Using the Crossover Comparison Structure of the Study)|Average pain score will be the average of daily pain scores (0-10) recorded by the subject in a pain diary during the second week of the two week treatment period. Higher scores are worse (0=no pain, 10=pain as bad as you can imagine).|Assessed at end of two week treatment period|8 participants were randomized, but 2 participants did not complete the second period of the study. So 6 participants received both sulfasalazine and placebo treatments, one only received sulfasalazine in period 1, and one only received placebo in period 1.|||units on a scale||Standard Deviation|Mean
2650698|NCT01667029|Primary|Pain Score (First Treatment Period)|Average pain score will be the average of daily pain scores (0-10) recorded by the subject in a pain diary during the second week of the two week treatment period. Higher scores are worse (0=no pain, 10=pain as bad as you can imagine).|second week of two week treatment period||||units on a scale||Standard Deviation|Mean
2650699|NCT01666951|Other Pre-specified|Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.|The efficacy is measured by the number of treatment failures defined as all-cause mortality, Graft Failure, Biopsy Proven Acute Rejection (BPAR) and Lost to follow up.|30 days||||participants|||Number
2650701|NCT01666951|Other Pre-specified|Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14.|"At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, nighttime dipping) between the two Groups at Days 14."|14 days|18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.|||ratio||Standard Deviation|Mean
2650702|NCT01666951|Primary|Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.|28 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||Percentage of fluctuation||Standard Deviation|Mean
2650703|NCT01666951|Primary|Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients.|14 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||Percentage of fluctuation||Standard Deviation|Mean
2650704|NCT01666951|Primary|Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.|28 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||hour||Standard Deviation|Mean
2650705|NCT01666951|Primary|Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients.|14 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||hour||Standard Deviation|Mean
2650706|NCT01666951|Primary|Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients.|1 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||hour||Standard Deviation|Mean
2650707|NCT01666951|Primary|Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.|28 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||ng/mL||Standard Deviation|Mean
2650708|NCT01666951|Primary|Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients.|14 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||ng/mL||Standard Deviation|Mean
2650709|NCT01666951|Primary|Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients.|1 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||ng/mL||Standard Deviation|Mean
2650710|NCT01666951|Primary|Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (AUC) was evaluated on Day 28 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.|28 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||ng*hr/mL||Standard Deviation|Mean
2650711|NCT01666951|Primary|Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (AUC) was evaluated on Day 14 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.|14 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||ng*hr/mL||Standard Deviation|Mean
2650712|NCT01666951|Primary|Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation|The pharmacokinetic parameter (AUC) was evaluated on Day 1 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.|1 days|The PK assessments were performed on the PK populations set which consists of 26 patients, 14 of whom received LCP-Tacro and 12 of whom who received Prograf.|||ng*hr/mL||Standard Deviation|Mean
2650713|NCT01666951|Other Pre-specified|Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.|"At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, nighttime dipping) between the two Groups at Day 28."|28 days|18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.|||mmHg||Standard Deviation|Mean
2650714|NCT01666951|Other Pre-specified|Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.|"At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, nighttime dipping) between the two Groups at Days 14."|14 days|18 patients participated in the 24-hour blood pressure assessment, 8 in the LCP-Tacro arm and 10 on the Prograf arm.|||mmHg||Standard Deviation|Mean
2650715|NCT01666912|Secondary|Rapid Repeat Pregnancy|To assess rapid repeat pregnancies among the study population, ie, the number of participants who reported a repeat pregnancy within 12 months postpartum.|12 months||||participants||95% Confidence Interval|Number
2650716|NCT01666912|Secondary|Satisfaction|"To assess satisfaction with the contraceptive implant inserted in the postpartum period, using a scale of 0-10, with 0 being not satisfied at all to 10 being extremely satisfied."|12 months||||units on a scale||Standard Deviation|Mean
2650717|NCT01666912|Primary|Continuation at 1 Year|The number of participants using the contraceptive implant at one year postpartum among women who have the implant placed immediately postpartum vs. at 6 weeks postpartum.|12-14 months||||participants|||Number
2650718|NCT01666782|Secondary|Evaluate and Compare the Local and Systemic Unsolicited Adverse Events to Both Vaccines.|Unsolicited adverse events occurring in more than one patient, standard-dose (SD) vaccine and high-dose (HD) vaccine|28 days||||participants|||Number
2650719|NCT01666782|Secondary|Evaluate and Compare the Systemic Solicited Adverse Events to Both Vaccines.|Systemic solicited adverse events, standard-dose (SD) vaccine and high-dose (HD) vaccine|7 days||||participants|||Number
2650723|NCT01666782|Primary|The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.|Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28.|Baseline and 28 days||||titers||95% Confidence Interval|Geometric Mean
2650724|NCT01666652|Secondary|Number of Subject Showing Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies - Total Vaccinated Cohort (TVC)|"Number of subjects showing Monovalent, bivalent, trivalent and tetravalent response for neutralizing antibodies by Microneutralization Titer (giving 50% reduction in viral infection (MN50)) in the TVC population.~PI(D7) = Post-dose 1, Day 7 visit PI(D28) = Post-dose 1, Day 28 visit PII(D56) = Post-dose 2, Day 56 visit PII(M4) = Post-dose 2, Month 4 visit PII(M7) = Post-dose 2, Month 7 visit PII(M10) = Post-dose 2, Month 10 visit PII(M13) = Post-dose 2, Month 13 visit"|up to month 13|subjects with available results for all four DENV-types (without missing N antibody titer)|||Participants|||Count of Participants
2650725|NCT01666652|Secondary|Geometric Mean Titers (GMTs) of Neutralizing Antibody Titers Specific to Each DENV Type - According to Protocol Population (ATP)|"Geometric Mean Titers (GMTs) of Neutralizing antibody titers specific to each DENV type were measured by a quantitative microneutralization assay with a titer giving 50% reduction in viral infection (MN50) at specified time points. MN50 is specific and sensitive for the detection of anti-DENV neutralizing antibodies. The cut-off for seropositivity was 1: 10 for neutralizing antibody titers measured by MN50 assay. MN50 assay was used to determine initial DENV antibody status of subjects for inclusion in the ATP cohort.~PRE = Pre-vaccination, Day 0 visit PI(D7) = Post-dose 1, Day 7 visit PI(D28) = Post-dose 1, Day 28 visit PII(D56) = Post-dose 2, Day 56 visit PII(M4) = Post-dose 2, Month 4 visit PII(M7) = Post-dose 2, Month 7 visit PII(M10) = Post-dose 2, Month 10 visit PII(M13) = Post-dose 2, Month 13 visit"|up to month 13|subjects with available data|||GMT||95% Confidence Interval|Mean
2650726|NCT01666652|Secondary|Number of Subjects With Laboratory Values Within and Outside the Normal Ranges and With Different Grade of Adverse Event From Screening to Day 56 Visit|"The percentage of subjects with hematological and biochemical laboratory values within and outside the normal ranges and with different grade of AE were tabulated with exact 95% CI at baseline and at each specified timepoint. Safety laboratory assays were performed at a WRAIR-designated Clinical Laboratory Improvement Amendments-certified laboratory. All safety-related clinical laboratory values were reviewed and all abnormal values were assessed by the investigators as clinically significant or not, with respect to safety.~PRE = Pre-vaccination, Day 0 visit PI(D7) = Post-dose 1, Day 7 visit PI(D28) = Post-dose 1, Day 28 visit PII(D35) = Post-dose 2, Day 35 visit PII(D56) = Post-dose 2, Day 56 visit PII(M4) = Post-dose 2, Month 4 visit PII(M7) = Post-dose 2, Month 7 visit PII(M10) = Post-dose 2, Month 10 visit PII(M13) = Post-dose 2, Month 13 visit"|day 56 visit||||Participants|||Count of Participants
2650727|NCT01666652|Primary|Summary of Subjects With Serious Adverse Events|Summary of subjects with serious adverse events through out the study|days 0-392||||Participants|||Count of Participants
2650728|NCT01666652|Primary|Incidence of Local Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period, Total Vaccinated Cohort (TVC)|Incidence of Local Symptoms (Solicited and Unsolicited) Reported during the 7-day Post Vaccination Period in TVC population. Local symptoms are described as pain, redness and swelling.|Days 0-6 post vaccination||||AEs|||Number
2650729|NCT01666652|Primary|Incidence of General Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period, Total Vaccinated Cohort (TVC)|Incidence of General Symptoms (Solicited and Unsolicited) Reported during the 7-day Post Vaccination Period for TVC population. General symptoms are described as fatigue, gastrointestinal symptoms, headache, joint pain, muscle aches and increased temperature (oral).|Days 0-6 post vaccination||||AEs|||Number
2650730|NCT01666652|Primary|Incidence of Any Symptoms (Solicited and Unsolicited) Reported During the 7-day Post Vaccination Period. Total Vaccinated Cohort (TVC)|Overall incidence of any symptoms (solicited and unsolicited) reported during the 7-day (days 0-6) post vaccination period in TVC population|Days 0-6 post vaccination||||AEs|||Number
2650731|NCT01666652|Primary|Number of Subjects With Adverse Events Within the 28 Day Follow-up|Number of subjects with adverse events occurring within days 0-28 following vaccination|Days 0-28||||Participants|||Count of Participants
2650732|NCT01666444|Secondary|Frequency and Severity of Adverse Events (AEs)|An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can be unfavorable and unintended sign, symptom, or disease which is temporally associated with the use of investigational product (IP), whether or not considered related to the IP. A serious AE = an AE occurring at any dose that: • Results in death • Is life- threatening • Requires or prolongs existing inpatient hospitalization • Results in persistent or significant disability/incapacity • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to IP and graded the severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0: Grade (GR) 1 = Mild; asymptomatic or mild symptoms; GR 2 = Moderate (minimal, local or noninvasive intervention indicated); GR 3 = Severe or medically significant; GR 4 = Life-threatening; GR 5 = Death|Assessed during each cycle of therapy and within 30 days after the last cycle of therapy|All patients who initiated study treatment. There were 147 patients who initiated treatment on each arm.|||participants|||Number
2650733|NCT01666444|Secondary|Progression-free Survival (PFS)|Comparison of PFS between the 2 treatment groups|Progression-free survival is measured from enrollment and randomization on the study until first indication of progression based on irRECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment.|All enrolled patients.|||days||Inter-Quartile Range|Median
2650734|NCT01666444|Primary|Overall Survival|Comparison of duration of survival between the 2 treatment groups|Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact.|All enrolled patients|||days||Inter-Quartile Range|Median
2650751|NCT01666314|Secondary|Percentage of Participants With PSA50 After 12 Weeks of Treatment|A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.|Baseline and Week 12|Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 12 Weeks of Treatment.|||percentage of participants||95% Confidence Interval|Number
2650735|NCT01666314|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding),symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|From signing of the informed consent form through 30 days after the last dose of study drug, approximately 3.2 years|Safety Population included all randomized participants who received at least one dose of study drug. Adverse events are summarized as per the treatment received.|||participants|||Number
2650736|NCT01666314|Secondary|Ctrough,ss: Observed Predose Plasma Concentration at Steady State for Orteronel and M-I Metabolite|Observed predose plasma concentration at steady state.|Cycle 1 Day 8 Predose|Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2650737|NCT01666314|Secondary|Rac: Accumulation Index for Orteronel and M-I Metabolite|Rac was calculated as the ratio of AUCtau to AUC12hr.|Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose|Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2650738|NCT01666314|Secondary|AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Orteronel and M-I Metabolite|Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.|Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose|Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2650739|NCT01666314|Secondary|Tmax,ss: Time to Reach the Maximum Plasma Concentration (Cmax), Equal to Time (Hours) to Cmax at Steady State for Orteronel and M-I Metabolite|Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax at steady state.|Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose|Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.|||hours||95% Confidence Interval|Median
2650740|NCT01666314|Secondary|Cmax,ss: Maximum Observed Plasma Concentration at Steady State for Orteronel and MI-Metabolite|Maximum observed steady-state plasma concentration during a dosing interval.|Cycle 1 Day 8 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose|Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2650741|NCT01666314|Secondary|AE (0-24) Cumulative Amount of Drug Excreted Into the Urine for Orteronel and MI-Metabolite|Cumulative amount of urine excreted time 0 to 24 hour.|Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose|Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.|||mg||Geometric Coefficient of Variation|Geometric Mean
2650742|NCT01666314|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.|Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose|Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.|||hours||Full Range|Median
2650743|NCT01666314|Secondary|AUC(0-12): Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours Post-dose for Orteronel and M-I Metabolite|AUC(0-12) is measure of area under the curve over the dosing interval where the length of the dosing interval is time 0 to 12 hours in this study.|Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose|Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2650744|NCT01666314|Secondary|Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.|Cycle 1 Day 1 Predose, 0.5, 1, 2, 3, 5, 8, 12 hours post-dose|Pharmacokinetic Population included all randomized participants who received orteronel in Cycle 1.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2650745|NCT01666314|Secondary|Absolute Values for Prostate-Specific Antigen (PSA)|Serum PSA was measured at the central laboratory.|Baseline and Cycle 2 Day 1|Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.|||ng/mL||Standard Deviation|Mean
2650746|NCT01666314|Secondary|Absolute Values for Cortisol|Serum Cortisol was measured by immunometric assay at the central laboratory.|Baseline, Cycle 1 Day 8 and Cycle 2 Day 1|Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.|||nmol/L||Standard Deviation|Mean
2650747|NCT01666314|Secondary|Absolute Values for Corticosterone|Serum Corticosterone was measured by high pressure liquid chromatography with mass spectrometry at the central laboratory.|Baseline, Cycle 1 Day 8 and Cycle 2 Day 1|Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.|||nmol/L||Standard Deviation|Mean
2650748|NCT01666314|Secondary|Absolute Values for Adrenocorticotropic Hormone (ACTH)|Serum ACTH was measured by immunometric assay at the central laboratory.|Baseline, Cycle 1 Day 8 and Cycle 2 Day 1|Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.|||pmol/L||Standard Deviation|Mean
2650749|NCT01666314|Secondary|Absolute Values for Dehydroepiandrosterone Sulfate (DHEA-S)|Serum Ultra low level quantification of DHEA-S was measured by liquid chromatography and mass spectrometry (LC/MS) at a central laboratory.|Baseline, Cycle 1 Day 8 and Cycle 2 Day 1|Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.|||nmol/L||Standard Deviation|Mean
2650804|NCT01665508|Secondary|Exercise Duration|Assessment of exercise duration as determined by CPET|3 months||||minutes||Standard Deviation|Mean
2650752|NCT01666314|Secondary|Percentage of Participants With Prostate-Specific Antigen Reduction ≥ 50% (PSA50) After 4 Weeks of Treatment|A 50% PSA response rate (PSA50) was defined as PSA reduction ≥ 50% from Baseline.|Baseline and Week 4|Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 4 Weeks of Treatment.|||percentage of participants||95% Confidence Interval|Number
2650753|NCT01666314|Secondary|Percent Change From Baseline in Serum Testosterone Level After 12 Weeks of Treatment|Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.|Baseline and Week 12|Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 12 Weeks of Treatment.|||percent change||Standard Deviation|Mean
2650754|NCT01666314|Secondary|Percent Change From Baseline in Serum Testosterone Level After 4 Weeks of Treatment|Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.|Baseline and Week 4|Participants from the Pharmacodynamics-evaluable population, defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement, with data available after 4 Weeks of Treatment.|||percent change||Standard Deviation|Mean
2650755|NCT01666314|Secondary|Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL in Ex-Japan|Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.|Baseline and Week 4|Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.|||percentage of participants||95% Confidence Interval|Number
2650756|NCT01666314|Primary|Percentage of Participants With Serum Testosterone Levels Reduced to ≤ 2 ng/dL After 4 Weeks of Treatment in Japan|Serum Ultra-sensitive testosterone was measured by liquid chromatography at a central laboratory.|Baseline and Week 4|Pharmacodynamics-evaluable population was defined as participants with a baseline and at least 1 post-baseline pharmacodynamics measurement.|||percentage of participants||95% Confidence Interval|Number
2650757|NCT01666210|Other Pre-specified|Adverse Events|Measure of adverse events over the duration of each subject's participation in the study.|Duration of each individual subject's participation in the study|Ocular adverse events|||percentage of participants|||Number
2650758|NCT01666210|Primary|Absence of Pain in the Study Eye||Day 8||||Participants|||Count of Participants
2650759|NCT01666210|Primary|Absence of Cells in Anterior Chamber of Study Eye||Day 8||||percentage of participants|||Number
2650760|NCT01666197|Primary|Pain on Movement|"Change on a Visual analog scale from Baseline. Pain on Movement at 48 hours assessed on a 100 mm visual analog scale with anchors at 0=No pain and 100= Extreme pain"|48 hours||||mm||Standard Deviation|Mean
2650761|NCT01666145|Secondary|Percentage of Participants With Significant Ease of Lesion Targeting Using Advanced Image Guidance (AIM)|A subjective grading scale from which the surgeon will provide the relative ease of lesion targeting using Advanced Image Guidance (AIM) and the guidance system; the scale will be numbered 1-5 with one being significantly difficult and five being significantly easy. The percentage of participants with a score of 5 is reported below.|Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.||||percentage of participants|||Number
2650762|NCT01666145|Primary|Successful Insertion of Ablation Antenna Into Target Lesion|Once the ablation antenna has been placed into the target lesion, the success or failure of the attempt will be confirmed with conventional ultrasound alone, in two planes. If the placement is deemed successful, the surgeon will commence the ablation of the tumor. If the placement is deemed insufficient, the probe will be removed and another placement will be attempted using conventional guidance.|Participants will be followed for the duration of hospital stay, an expected average of 2 to 3 days.||||percentage of participants|||Number
2650763|NCT01666119|Primary|Adverse Events|Adverse events that occur in more than 2 subjects. Among the adverse events that occurred in > 2 subjects, the total number of unique events that were experienced are reported.|12 weeks|All subjects who received at least 1 dose of study drug.|||adverse events|||Number
2650764|NCT01666119|Secondary|Urine Drug Screen|Urine samples collected at screening and baseline to test for the presence of non-prescribed opioids.|12 weeks|Subjects with at least one urine drug screen test during the treatment period.|||participants|||Number
2650765|NCT01666002|Secondary|Proximal Clearance of Fungus on Nail|The secondary end point was proximal nail plate clearance as assessed directly by a single study physician, who measured the clinical involvement defined as total length of abnormal nail per each nail of each of the patients' toenails, and confirmed by digital analysis of toenail photographs with ImageJ software.|1 year||||mm|Participants|Standard Deviation|Mean
2650766|NCT01666002|Primary|The Primary End Point Was the Percentage of Patients With a Negative Mycological Culture.||1 year||||percentage of participants|||Number
2650767|NCT01665950|Primary|Change in MADRS (4 Weeks)|Change in Montgomery-Asberg Depression Rating Scale (MADRS) in simvastatin-treated epochs versus placebo-treated epochs|Baseline vs week 4 (and, for placebo nonresponders in 1st 4 weeks, week 8 vs week 4)||||units on a scale|||Number
2650768|NCT01665911|Secondary|Enamel Fluoride Uptake Per Each of Five Arms|Enamel fluoride uptake is a measure of fluoridation of a caries lesion|Three Weeks per each of five arms||||microgram fluoride per square cm||Standard Error|Least Squares Mean
2650769|NCT01665911|Secondary|% Acid Resistance Score Per Each of Five Arms|% Acid Resistance is a measure of acid resistance of the remineralized caries lesion which is calculated as (D1-D2)/(D1-B)*100%, where B is the indentation length of sound enamel specimen at baseline, D1 is an indentation length after first in vitro demineralization, D2 is an indentation length after second in vitro demineralization.|Three Weeks per each of five arms||||percent||Standard Error|Least Squares Mean
2650770|NCT01665911|Primary|% Surface Microhardness (SMH) Recovery Score Per Each of Five Arms|"surface microhardness recovery is a measure of caries lesion remineralization and is calculated using the following equation:~SMHr=(D1-R)/(D1-B)×100 B = indentation length of sound enamel specimen at baseline D1 = indentation length after first in vitro demineralization R = indentation length after intra-oral exposure (rehardening)."|Three Weeks per each of five arms||||percent||Standard Error|Least Squares Mean
2652423|NCT01652703|Secondary|Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.|||mg/dL||Standard Error|Least Squares Mean
2650771|NCT01665872|Primary|Implementation Cost|The implementation cost of providing a 8 session Stress Management (SM) Series (with 1 active series at a time) for both Standard of care with only a clinician, and also for a clinician and CMHA. The implementation costs include startup costs and on-going costs. On-going costs include staff salary, travel time, cell phones, space, and materials).|1 series|Since we are looking at implementation cost this measure isn't participant based, but calculated on what it would cost to run one series.|||American Dollars|1 SM series||Number
2650772|NCT01665872|Primary|Gainful Employment|Measure of subject's ability to obtain gainful employment|1 year|Participants who attended 12 month follow-up assessment.|||Participants|||Count of Participants
2650773|NCT01665872|Primary|Parenting Stress|Parenting Stress Index Short Form by Richard R. Abidin (total score (36 questions) and 3 subscales (12 questions each) was used to describe parenting stress. Scores were created by summing the responses and then translated to percentiles for normative data (provided by the publisher). The total score represents an overall level of experienced parenting stress. A score 90 or above indicates experiencing clinically significant levels of stress. The subscale Parental Distress measures distress that the parent is experiencing related to parenting. High scores indicate more distress. The Parent-Child Dysfunctional Interaction subscale measures the parent's perception regarding a child meeting expectations and reinforcing interactions with the child. High scores indicate a parent-child bond that is threatened or not adequately established. The Difficult Child subscale looks at behavioral characteristics of children. Higher scores indicating difficulty managing the child's behavior.|1 year|This questionnaire was only administered to participants who had a child 8 years or older. Results are from participants who attended the 12 month follow-up assessment.|||percentile||Inter-Quartile Range|Median
2650774|NCT01665872|Primary|Depressive and Anxiety Symptoms (CES-D)|"The Center for Epidemiologic Studies Depression Scale (CES-D) is a screening test for depression and depressive disorder. The total score is a sum which ranges from 0-60. Higher scores indicate the presence of more symptomatology.~Radloff, L.S. (1977) 'The CES-D scale: A self report depression scale for research in the general population'. Applied Psychological Measurement 1: 385-401."|approximately 1 year|Participants who attended the 12 month follow-up assessment.|||units on a scale||Inter-Quartile Range|Median
2650775|NCT01665872|Primary|Total Outpatient Mental Health or Substance Abuse Visits|Self-report questionnaire which measure attitudes toward seeking mental health treatment. This is defined by looking at total number of outpatient mental health or substance abuse treatment visits in the past year.|1 year|Participants who attended the 12 month follow-up assessment and completed the questions regarding mental health and substance abuse visits.|||visits||Standard Deviation|Mean
2650776|NCT01665807|Secondary|Pain at Injection Site|Self-perceived pain of injection will be recorded on an 11-point visual analogue scale immediately following vaccination (Day 0) and at follow-up (Day 8)|Follow up (Day 8|||||||
2650777|NCT01665807|Secondary|Local & Systemic Reactogenicity|Maximum self-reported diameter of redness, induration, and swelling, and maximum intensity and duration of itchiness, fever, muscle ache, joint pain, headache, fatigue, feeling unwell, and injection site pain as reported on Day 8 after vaccination|Follow up (Day 8)|||||||
2650778|NCT01665807|Secondary|Success Rate|Successful administration, defined as being able to self-vaccinate (or for RN to provide vaccine) on the first attempt. Will be calculated using the number of participants who are successful divided by the number of participants randomized to group.|Vaccination (Day 0)||||participants|||Number
2650779|NCT01665807|Secondary|Acceptability of Vaccine|The post-vaccination (Day 0) and follow-up (Day 8) questionnaires include questions on the participant's preference for intradermal or intramuscular injections and questions about their preference for administration by a healthcare provider or self-vaccination.|Follow up (Day 8)|||||||
2650780|NCT01665807|Primary|Time to Administer Influenza Vaccine (in Seconds)|Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination|Vaccination (Day 0)||||seconds||Full Range|Median
2650781|NCT01665768|Secondary|Percentage Change in Cancer Cells When mTOR Kinase Inhibition is Applied|Percentage change in cancer cells when mTOR inhibition is applied in the laboratory. Samples from participants will be evaluated at each timepoint noted below.|1 year, 2 years, and 3 years|||||||
2650782|NCT01665768|Secondary|Percentage Change in the Frequency of Circulating Cancer Cells|Percentage change in circulating cancer cells between baseline and each timepoint noted below.|Baseline, 1 year, 2 years and 3 years|||||||
2650783|NCT01665768|Secondary|Event Free Survival (EFS)|Percentage of participants alive without disease progression. As defined by Cheson criteria, disease progression is a new lesion or >= 50% increase in the size of previously identified sites of disease. EFS was estimated using Kaplan-Meier survival analysis.|2.5 years||||percentage of participants||95% Confidence Interval|Number
2650784|NCT01665768|Primary|Safety as Assessed by Avoidance of Grade 3-4 Adverse Events|Number of participants who did not experience at least one grade 3-4 adverse event by CTCAE 4.0.|Up to 3 years||||Participants|||Count of Participants
2650785|NCT01665599|Secondary|Change From Baseline in the SF-12 Health Questionnaire|"Data collected from the SF-12 questionnaire was used to assess improvement in the psychometrically-based physical component summary (PCS) and mental component summary (MCS). Both PCS and MCS contains four sub-domains:~PCS: General Health (1 item), Physical Functioning (2 items), Role-Physical (2 items), Bodily Pain (1 item)~MCS: Role-Emotional (2 items), Mental Health (2 items), Vitality (1 item), Social Functioning (1 item)~The scale scores are calculated by summing responses across scale items and then transforming these raw scores to a 0-100 scale. Computerized scoring algorithms are used to produce norm-based scores for each scale (mean of 50 and standard deviation of 10) as well as the PCS and MCS summary scores. A zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.~The data were presented using descriptive statistics."|Day 91|ITT population was used which comprised of all participants who received at least one dose of IMP.|||units on a scale||Standard Deviation|Mean
2650823|NCT01665170|Secondary|Sympathovagal Balance (During TSST, Interview - 4. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|during TSST||||(low frequency/high frequency)*10||Standard Deviation|Mean
2650786|NCT01665599|Secondary|Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Questionnaire|"The MAF contains four sub-domains:~Severity (2 items, questions 1-2) (Score range: 2-20)~Distress (1 item, question 3) (Score range: 1-10)~Degree of interference in activities of daily living (11 items, questions 4-14) (Score range: 11-110)~Timing (2 items, questions 15-16) (Score range: 5-20)~A score of 1-10 is awarded to each of the 14 questions across the 3 domains. The timing domain is categorical and was converted to 1-10 scale by multiplying each score by 2.5. Lower score in each domain indicates improvement in fatigue.~To calculate GFI : Score of question 15 is converted to a 0-10 scale by multiplying each score by 2.5 and then sum questions 1, 2, 3, average of 4-14, and newly scored question 15. A score of zero is assigned to question 2-16, if patient select 'no fatigue' to question 1. Question 16 is not included in GFI calculation. Range of GFI: 1 (no fatigue) to 50 (severe fatigue).~The data were presented using descriptive statistics."|Day 91|ITT population was used which comprised of all participants who received at least one dose of IMP.|||units on a scale||Standard Deviation|Mean
2650787|NCT01665599|Secondary|Change From Baseline in the International Index of Erectile Dysfunction (IIEF) Questionnaire|"Data collected from the five domains of sexual functions were summarized by descriptive statistics. The domains are:~Erectile function (6 items, questions 1-5 and 15) (Score range: 1-30)~Orgasmic function (2 items, questions 9-10) (Score range: 0-10)~Sexual desire (2 items, questions 11-12) (Score range: 2-10)~Intercourse satisfaction (3 items, questions 6-8) (Score range: 0-15)~Overall satisfaction (2 items, questions 13-14) (Score range: 2-10)~A score of 0-5 is awarded to questions 1 to 10 and a score of 1-5 is awarded to questions 11 to 15. Total score was calculated by summing up scores of each domain and ranged from 5 to 75. Low score indicates severe dysfunction and a high score indicates no dysfunction in sexual function."|Day 91|ITT population was used which comprised of all participants who received at least one dose of IMP.|||units on a scale||Standard Deviation|Mean
2650788|NCT01665599|Secondary|Pharmacokinetics of DHT Measuring Tmin|A validated LC/MS/MS method was used to determine the levels of DHT.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||hour||Full Range|Median
2650789|NCT01665599|Secondary|Pharmacokinetics of DHT Measuring Cmin|A validated LC/MS/MS method was used to determine the levels of DHT.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||ng/dL||Standard Deviation|Mean
2650790|NCT01665599|Secondary|Pharmacokinetics of DHT Measuring Cave|A validated LC/MS/MS method was used to determine the levels of DHT.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||ng/dL||Standard Deviation|Mean
2650791|NCT01665599|Secondary|Pharmacokinetics of DHT Measuring Cmax|A validated LC/MS/MS method was used to determine the levels of DHT.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||ng/dL||Standard Deviation|Mean
2650792|NCT01665599|Secondary|Pharmacokinetics of DHT Measuring Tmax|A validated LC/MS/MS method was used to determine the levels of DHT.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||hour||Full Range|Median
2650793|NCT01665599|Secondary|Pharmacokinetics of DHT (Dihydrotestosterone) Measuring AUCτ|A validated LC/MS/MS method was used to determine the levels of DHT.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||ng*hr/dL||Standard Deviation|Mean
2650794|NCT01665599|Secondary|Pharmacokinetics of Total Testosterone Measuring Time of Minimum Observed Concentration (Tmin)|A validated LC/MS/MS method was used to determine the levels of total testosterone.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||hour||Full Range|Median
2650795|NCT01665599|Secondary|Pharmacokinetics of Total Testosterone Measuring Minimum Concentration Observed (Cmin)|A validated LC/MS/MS method was used to determine the levels of total testosterone.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||ng/dL||Standard Deviation|Mean
2650796|NCT01665599|Secondary|Pharmacokinetics of Total Testosterone Measuring Average Steady State Concentration (Cave)|A validated LC/MS/MS method was used to determine the levels of total testosterone.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||ng/dL||Standard Deviation|Mean
2650797|NCT01665599|Secondary|Pharmacokinetics of Total Testosterone Measuring Maximum Concentration Observed (Cmax)|A validated LC/MS/MS method was used to determine the levels of total testosterone.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||ng/dL||Standard Deviation|Mean
2650798|NCT01665599|Secondary|Pharmacokinetics of Total Testosterone Measuring Time of Maximum Observed Concentration (Tmax)|A validated LC/MS/MS method was used to determine the levels of total testosterone.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||hour||Full Range|Median
2650799|NCT01665599|Secondary|Pharmacokinetics of Total Testosterone Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hours Post-dose (AUCτ)|A validated high pressure liquid chromatography with tandem mass spectrometry detection (LC/MS/MS) method was used to determine the levels of total testosterone.|Day 1; Day 90|ITT population was used which comprised of all participants who received at least one dose of IMP.|||ng*hr/dL||Standard Deviation|Mean
2650800|NCT01665599|Secondary|The Percentage of Participants on Day 1 Whose Serum Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL|The data were presented using descriptive statistics. No statistical analysis was performed.|Day 1|FAS population was used which comprised of subjects who had any available PK data for testosterone on Day 90.|||percentage of participants|||Number
2650801|NCT01665599|Primary|The Percentage of Subjects on Day 90 Whose Cavg (0-24) Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL|The data were presented using descriptive statistics. No statistical analysis was performed.|Day 90|Full Analysis set (FAS) population was used which comprised of subjects who had any available pharmacokinetic (PK) data for testosterone on Day 90.|||percentage of participants|||Number
2650802|NCT01665508|Secondary|Peak O2 Pulse|peak O2 pulse as measured by cardiopulmonary exercise testing|3 months||||ml/beat||Standard Deviation|Mean
2650803|NCT01665508|Secondary|Peak Heart Rate as Measured by Cardiopulmonary Exercise Testing|Assessment of peak heart rate as determined by CPET|3 months||||beats per minute||Standard Deviation|Mean
2650842|NCT01665170|Secondary|Norepinephrine (Before)|2 min. prior the TSST|before stress test||||ng/dl||Standard Deviation|Mean
2650805|NCT01665508|Secondary|SF36|The SF-36v2 is a commonly used instrument to assess HRQoL8. The questionnaire evaluates 8 HRQoL domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The physical component score is a composite of the SF-36v2 physical health domains (physical functioning, role-physical, bodily pain and general health) and the mental component score a composite of the mental health domains (vitality, social functioning, role-emotional and mental health). Each HRQoL domain score ranges from 0 to 100, with higher scores corresponding to a better health status. The SF-36v2 domain scores were calculated using the QualityMetric Health Outcomes Scoring Software version 4.5.|baseline and 12 week follow-up|physical functioning reported below|||units on a scale||Standard Deviation|Mean
2650806|NCT01665508|Secondary|Resource Utilization Questionnaire|Resource utilization as determined by patient phone calls, office visits, emergency room visits, and number of hospitalizations, as well an index cost for any hospitalizations|3 months|data was not collected||||||
2650807|NCT01665508|Secondary|Peak VO2 Measured by Cardiopulmonary Exercise Testing|Assessment of exercise capacity (peak VO2) as determined by CPET|3 months||||ml/beat||Standard Deviation|Mean
2650808|NCT01665508|Primary|Seattle Angina Questionnaire Score|"Seattle Angina Questionnaire (SAQ):~The SAQ is a 5 part survey that is widely used and well validated tool to assess angina stability and angina frequency among patients with coronary artery disease.~The SAQ is a validated, self-administered 19-item questionnaire with 5 different dimensions of health status in patients with CAD including: angina frequency, angina stability, disease-specific quality of life, physical limitations and treatment satisfaction. Each SAQ domain score ranges from 0-100, with higher scores indicating a better health status."|3 months|7 patients complete baseline and followup data reported below is anginal stability|||units on a scale||Standard Deviation|Mean
2650809|NCT01665430|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)|"The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ-DI scale was an average of all the scores from all questions and ranged from 0 to 3, where higher scores represented higher disease activity. Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from study for reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with Unspecified reason of discontinuation were excluded for change from baseline analysis."|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to 104 weeks)|ITT population. Number Analyzed = participants who were evaluable for specified category.|||units on a scale||Standard Deviation|Mean
2650810|NCT01665430|Secondary|Change From Baseline in Participant Assessment of Pain Using VAS|"Severity of pain was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the severity of pain that they had experienced because of their RA, ranging from 0 mm (no pain) to 100 mm (unbearable pain). Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from the study for the reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with Unspecified reason of discontinuation were excluded for change from baseline analysis."|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to 104 weeks)|ITT population. Number Analyzed = participants who were evaluable for specified category.|||mm||Standard Deviation|Mean
2650811|NCT01665430|Secondary|Change From Baseline in PtGA of Disease Activity Using VAS|"The PtGA of disease activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equaled 0 mm, and was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, and was described as maximum disease activity (maximum arthritis disease activity). A negative change from baseline indicated improvement. Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from the study for the reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with Unspecified reason of discontinuation were excluded for change from baseline analysis."|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to 104 weeks)|ITT population. Number Analyzed = participants who were evaluable for specified category.|||mm||Standard Deviation|Mean
2650812|NCT01665430|Secondary|Change From Baseline in Physician's Global Assessment (PGA) of Disease Activity Using Visual Analog Scale (VAS)|"The PGA of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equaled 0 mm, and was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, and was described as maximum disease activity (maximum arthritis disease activity). A negative change from baseline indicated improvement. Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from the study for the reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with Unspecified reason of discontinuation were excluded for change from baseline analysis."|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to 104 weeks)|ITT population. Number Analyzed = participants who were evaluable for specified category.|||mm||Standard Deviation|Mean
2650813|NCT01665430|Secondary|Time to Rheumatoid Arthritis (RA) Flare in Participants Who Had Entered Drug-Free Remission|Time to RA flare was defined as the period of drug-free remission (having DAS28-ESR score <2.6 for 2 consecutive assessment visits followed by discontinuation of tocilizumab at the second assessment visit) until documented RA flare. RA flare was defined as any worsening of the participant's disease activity that, in the opinion of the Investigator, required treatment intensification beyond supportive therapy which could include restarting the study drug.|Baseline up to Week 104 (assessed at Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit [Week 104], at early withdrawal [up to 104 weeks])|The time to RA flare could not be evaluated as none of the participants showed drug-free remission.||||||
2650814|NCT01665430|Secondary|Percentage of Participants With Clinical Remission|Clinical remission was defined as having DAS28-ESR score <2.6 at any point during the study. DAS28-ESR was calculated from swollen joint count and tender joint count using 28 joints count, ESR, (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment on a 0 to 100 mm VAS; higher scores indicating greater affectation due to disease activity). Total DAS28-ESR transformed score range: 0 to approximately 10, higher score=more disease activity.|Baseline up to Week 104 (assessed at Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit [Week 104], at early withdrawal [up to 104 weeks])|ITT population|||percentage of participants|||Number
2650815|NCT01665430|Secondary|Percentage of Participants With Drug-Free Remission|Drug-free remission was defined as having clinical remission (defined as DAS28-ESR score <2.6) for 2 consecutive assessment visits followed by discontinuation of tocilizumab at the second assessment visit. DAS28-ESR was calculated from swollen joint count and tender joint count using 28 joints count, ESR, (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment on a 0 to 100 mm VAS; higher scores indicating greater affectation due to disease activity). Total DAS28-ESR transformed score range: 0 to approximately 10, higher score=more disease activity.|Baseline up to Week 104 (assessed at Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit [Week 104], at early withdrawal [up to 104 weeks])|ITT population|||percentage of participants|||Number
2650816|NCT01665430|Secondary|Change From Baseline in Total Swollen Joint Counts (28 Joints)|"The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 28 joints and were classified as swollen/not swollen giving a total possible swollen joint count of 0 to 28. Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from the study for the reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with Unspecified reason of discontinuation were excluded for change from baseline analysis."|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to Week 104)|ITT population. Number Analyzed = participants who were evaluable for specified category.|||swollen joints||Standard Deviation|Mean
2650817|NCT01665430|Secondary|Change From Baseline in Total Tender Joint Counts (28 Joints)|"The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 28 joints and joints were classified as tender/not tender giving a total possible tender joint count of 0 to 28. Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from the study for the reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with Unspecified reason of discontinuation were excluded for change from baseline analysis."|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to Week 104)|ITT population. Number Analyzed = participants who were evaluable for specified category.|||tender joints||Standard Deviation|Mean
2650818|NCT01665430|Secondary|Change From Baseline in Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Score|"DAS28-ESR was calculated from swollen joint count and tender joint count using 28 joints count, erythrocyte sedimentation rate (ESR, in millimeters per hour [mm/hour]) and patient global assessment (PtGA) of disease activity (participant rated arthritis activity assessment on a 0 to 100 millimeter [mm] visual analog scale [VAS]; higher scores indicating greater affectation due to disease activity). Total DAS28-ESR transformed score range: 0 to approximately 10, higher score=more disease activity. Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from the study for the reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with Unspecified reason of discontinuation were excluded for change from baseline analysis."|Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to Week 104)|ITT population. Number Analyzed = participants who were evaluable for specified category.|||units on a scale||Standard Deviation|Mean
2650819|NCT01665430|Primary|Percentage of Participants With Adverse Events (AEs), AEs of Special Interest and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include serious as well as non-serious AEs. AEs of special interest included: Infections including all opportunistic infections and non-serious infections as defined by those treated with IV anti-infectives; Myocardial infarction/acute coronary syndrome; Gastrointestinal perforations and related events; Malignancies; Anaphylaxis/Hypersensitivity reactions; Demyelinating disorders; Stroke; Bleeding events; and Hepatic events.|Baseline up to 112 weeks|ITT population|||percentage of participants|||Number
2650820|NCT01665170|Secondary|Sympathovagal Balance (After TSST, Sitting - 7. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|after TSST||||(low frequency/high frequency)*10||Standard Deviation|Mean
2650821|NCT01665170|Secondary|Sympathovagal Balance (After TSST, Standing - 6. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|after TSST||||(low frequency/high frequency)*10||Standard Deviation|Mean
2650822|NCT01665170|Secondary|Sympathovagal Balance (During TSST, Arithmetics - 5. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|during TSST||||(low frequency/high frequency)*10||Standard Deviation|Mean
2650824|NCT01665170|Secondary|Sympathovagal Balance (During TSST, Preparation - 3. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|during TSST||||(low frequency/high frequency)*10||Standard Deviation|Mean
2650825|NCT01665170|Secondary|Sympathovagal Balance (Before TSST, Standing - 2. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|before TSST||||(low frequency/high frequency)*10||Standard Deviation|Mean
2650826|NCT01665170|Secondary|Sympathovagal Balance (Before TSST, Sitting - 1. Measurement)|Sympathovagal balance is a measure of heart rate variability and gives information about the autonomic state that is regulated by sympathetic and parasympathetic influences. The low frequency component reflects sympathic activity, whereas the high requency domain gives Information about the parasympatic activity. Higher scores indicate a higher activation of the sympathic nervous System.|before TSST||||(low frequency/high frequency)*10||Standard Deviation|Mean
2650827|NCT01665170|Secondary|Norepinephrine (After)|2 min. after the TSST, higher value is better|1 day||||ng/dl||Standard Deviation|Mean
2650828|NCT01665170|Secondary|LSEQ Questionnaire (Behavior Following Awakening- Less Clumsy Balance and Coordination Upon Getting-up] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; a higher value is a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)||||Percent Change||Standard Deviation|Mean
2650829|NCT01665170|Secondary|LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Now] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.~V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)||||Percent Change||Standard Deviation|Mean
2650830|NCT01665170|Secondary|LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Upon Awakening] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)||||Percent Change||Standard Deviation|Mean
2650831|NCT01665170|Secondary|LSEQ Questionnaire (Awakening From Sleep- Quicker Than Usual] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)||||Percent Change||Standard Deviation|Mean
2650832|NCT01665170|Secondary|LSEQ Questionnaire (Awakening From Sleep- Easier Than Usual] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)||||Percent Change||Standard Deviation|Mean
2650843|NCT01665170|Secondary|Epinephrine (Before)|2 min. prior the TSST|1 day|||||||
2650833|NCT01665170|Secondary|LSEQ Questionnaire (Quality of Sleep - Fewer Periods of Wakefulness Than Usual] Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2, visite 3||||Percent Change||Standard Deviation|Mean
2650834|NCT01665170|Secondary|LSEQ Questionnaire (Quality of Sleep - More Restful Than Usual] - Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)||||Percent Change||Standard Deviation|Mean
2650835|NCT01665170|Secondary|LSEQ Questionnaire (Getting to Sleep-Feeling More Drowsy Than Usual] - Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; lower values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)||||Percent Change||Standard Deviation|Mean
2650836|NCT01665170|Secondary|LSEQ Questionnaire (Getting to Sleep-Falling Asleep More Quickly Than Usual] - Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3. V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded.~The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)||||Percent Change||Standard Deviation|Mean
2650837|NCT01665170|Primary|VAS Stress Perception (During)|The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.|during stress test = Visite 3||||mm||Standard Deviation|Mean
2650838|NCT01665170|Secondary|LSEQ Questionnaire (Getting to Sleep-Falling Asleep Easier Than Usual) - Changes From V2 to V3|"The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.~V2 = For each female, V2 is scheduled to take place on day 6 (-8) after the last contraceptive intake of a menstrual cycle. Upon arrival, subjects meeting all inclusion and no exclusion criteria are admitted to study participation and receive a random number starting from R001. V3 = After 2 days of treatment, the final appointment takes place in the afternoon. For each female, the appointment for V3 will be scheduled to take place on day 9 (-11) after the last contraceptive intake of a menstrual cycle. Females will be asked if oral contraceptives were administered on a regular basis and if pregnancy can be excluded. The LSEQ is a VAS scale 0 - 100mm, the value below is Change in percent; higher values represent a better outcome."|Visite 2 (before treatment), Visite 3 (after treatment)||||Percent Change||Standard Deviation|Mean
2650839|NCT01665170|Secondary|MDBF Questionnaire|"The MDBF assesses the three bipolar dimensions good/bad mood, wakefulness/tiredness and calmness/agitation (3 scales). The short form of the MDBF and its parallel version (versions A and B) each consist of 12 items. Subjects rate their mood state on a 5-point rating scale ranging from 1 = not at all to 5 = very true. To determine mood changes induced by the TSST, the questionnaire is completed shortly before (version A) and immediately after the TSST (version B). Assess before and after V3"|1 day|||||||
2650840|NCT01665170|Secondary|POMS Questionnaire|"The POMS assesses the four states depression/anxiety, fatigue, vigor and hostility (4 scales). High vigor scores reflect a positive mood whereas high scores in the other subscales indicate negative mood. Subjects rate their mood state on a 7-point rating scale ranging from 1 = not at all to 7 = very strongly. The questionnaire is completed on V2 and V3."|1 day|||||||
2650841|NCT01665170|Secondary|State Anxiety (STAI-X1) Questionnaire|"The STAI-X1 measures state anxiety (one scale). Answers are given on a four-point rating scale ranging from 1 = not at all to 4 = very true. The questionnaire is used as baseline measurement at V2. In addition, it is also employed before and immediately after the stress test at V3 to assess changes in state anxiety. Assess V2, before and after V3"|1 day|||||||
2650846|NCT01665170|Primary|VAS Anxiety (During)|The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.|during stress test = Visite 3||||mm||Standard Deviation|Mean
2650847|NCT01665170|Primary|VAS Insecurity (During)|The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.|during stress test = Visite 3||||mm||Standard Deviation|Mean
2650848|NCT01665157|Primary|Segmental Cleansing Level at Colonoscopy (Right Segment Preparation Failure)|"Segmental score of Ottawa bowel preparation scale was analyzed. The proportion of right segment preparation failure, defined as segmental score as 3 poor or 4 inadequate, was presented."|1 day||||percentage of participants|||Number
2650849|NCT01665157|Secondary|Convenience of Different Low Residual Diet and Bowel Preparation Protocol|It represented the percentage of participants who thinks the protocol is easy to use.|1 day||||percentage of participants|||Number
2650850|NCT01665157|Secondary|Satisfaction of Different Low Residual Diet and Bowel Preparation Protocol|It represented the percentage of participants who is satisfied with the protocol.|1 day||||Percentage of participants|||Number
2650851|NCT01665157|Primary|Total Volume of Purgatives That Ingested|The total volume of PEG-ELS (Liter) that ingested or could be ingested by examinee before colonoscopy|1 day||||Liter||Standard Deviation|Mean
2650852|NCT01665157|Secondary|Willingness to Choose the Same Protocol After Different Low Residual Diet and PEG-ELS Protocol|It represent the proportion of participants who wanted to choose the same protocol as they received in this trial.|1 day||||percentage of participants|||Number
2650853|NCT01665157|Primary|Overall Cleansing Level at Colonoscopy by Aronchick Scale|"The overall proportion of participants scored as Excellent or Good by Aronchick scale.~Description of Aronchick scale:It categorized colon cleansing into 5 level: Excellent, good, fair, poor, inadequate. It is categorical and cannot be summed. We will present"|1 day||||percentage of participants|||Number
2650854|NCT01665157|Primary|Overall Cleansing Level at Colonoscopy by Ottawa Bowel Preparation Scale|Ottawa preparation scale: Colon is defined into 3 segments: Right(cecum, ascending), mid(transverse, descending), rectosigmoid. Each is scored from 0 to 4, 0 is best and 4 is worst. Fluid quantity of whole is scored as 0, small; 1, moderate; 2 large amount. The scale will be summation of the clearness of 3 segments of colon and overall fluid quantity. It ranged from 0 to 14, 0 is the most clean colon and 14 is the most dirty one. Segment score will be analyzed separately as continuous variable.|1 day||||units on a scale||Standard Deviation|Mean
2650855|NCT01665144|Secondary|Effect on 3-month Confirmed Disability Progression as Defined by EDSS in Predefined Sub-groups|effect on confirmed disability progression in pre-defined subgroups, including patients with or without superimposed relapses, rapidly evolving patients with 1.5 point or greater change in EDSS score in 2 years prior to enrollment into the study. Patients with score of 4 or more in MSSS and those who don't meet this criteria.|Baseline, every 3 months up to the maximum of approximately 3 years||2024-07-31|07/2024||||
2650856|NCT01665144|Secondary|Effect on Inflammatory Disease Activity and Burden of Disease as Measured by MRI|Effect of BAF312 relative to placebo on disease activity and burden of disease as measured by Gd-T1 lesion, new/enlarged T2 lesion, and brain atrophy on brain MRI scans.|Baseline, every 12 month up to the maximum of approximately 3 years||2024-07-31|07/2024||||
2650857|NCT01665144|Secondary|Overall Response Rate on the MSWS-12.|The overall response of the effect of BAF312 compared to placebo patients on the patient reported outcome form MSWS-12.|Baseline, every 6 months up to the maximum of approximately 3 years||2024-07-31|07/2024||||
2650858|NCT01665144|Secondary|Efficacy of BAF Relative to Placebo in Annualized Relapses Rate and Time to the First Relapse|BAF312 vs placebo measured by the effect on confirmed relapses rate, the time to the first relapse, and proportion of patient free from relapses.|Baseline every 3 months up to the maximum of approximately 3 years||2024-07-31|07/2024||||
2650859|NCT01665144|Secondary|The Delay in Time to Confirmed Disability Progression as Measured by EDSS.|Confirmed disability is defined as increase of score of 1 point in patients with baseline score of 3.0 to 5.0 and 0.5 point increase with baseline score of 5.5 to 6.5.|Baseline, every 6 months up to the maximum of approximately 3 years||2024-07-31|07/2024||||
2650860|NCT01665144|Secondary|Efficacy of BAF312 Relative to Placebo in Reducing the Increase in T2 Lesion Volume|The reduction of the increase in the T1 lesion volume.|Baseline, every year up to the maximum of approximately 3 years||2024-07-31|07/2024||||
2650861|NCT01665144|Secondary|Efficacy of BAF312 Relative to Placebo in Confirmed Worsening of 25 Foot Walk Test|Delay in time to 3 month confirmed worsening of at least 20% from baseline in the timed 25 foot walk test.|Baseline , every 3 months up to the maximum of approximately 3 years||2024-07-31|07/2024||||
2650862|NCT01665144|Primary|Percentage of Participants With 3-month Confirmed Disibility Progression (CDP) Events as Measured by the Expanded Disability Status Scale (EDSS)|The EDSS uses an ordinal scale to assess neurologic impairment in MS based on a neurological examination. Scores in each of 7 functional systems (Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel & Bladder, and Cerebral) and an ambulation score were combined to determine the EDSS steps, ranging from 0 (normal) to 10 (death due to MS). Confirmed disability is defined as an increase of score of 1 point in patients with baseline score of 3.0 to 5.0 and 0.5 point increase with baseline score of 5.5 to 6.5.|Baseline, every 3 month up to the maximum of approximately 3 years|The Full analysis set (FAS), which comprised all randomized patients with assigned treatments who took at least one dose of study medication, was considered for the analysis. Only participants from the FAS with non-missing covariates were analyzed for this outcome.|||Percentage of participants|||Number
2650863|NCT01665092|Primary|Delta SOFA Score|Sequential Organ Failure Assessment Score (0-24 range). Delta SOFA is calculated as (SOFA Score at 48 hours post enrollment minus SOFA Score at enrollment). A negative value indicates improvement in the score.|48 hours||||units on a scale||Standard Deviation|Mean
2650866|NCT01665053|Secondary|Periprocedural Clinical Procedural Success Rate|Procedural Success Rate is defined as post-procedure diameter less then 30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions without occurrence of in-hospital cardiac death, MI, TVR. Procedural success rate is subject based.|Day 1 (periprocedure)|Intent-to-Treat population|||percentage of subjects|||Number
2650867|NCT01665053|Secondary|Periprocedural Technical Success Rate.|Technical Success Rate is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis less then 30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion. Technical success is lesion based.|Day 1 (periprocedure)|"Intent-to-Treat analysis set. Promus Element Plus population: 838 subject analyzed with 1043 lesions treated with technical success achieved in 1011 lesions.~SYNERGY population: 846 subjects analyzed with 1059 lesions treated with technical success achieved in 1041 lesions."|||percentage of lesions|||Number
2650868|NCT01665053|Secondary|Percentage of Patients With a Stroke at 12 Month.|The stroke rate includes: Ischemic- , Hemorraghic- & Undetermined Stroke.|12 months|Intent-to-Treat population.|||percentage of participants|||Number
2650869|NCT01665053|Secondary|Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.||12 months|Intent-to-treat population.|||percentage of participants|||Number
2650870|NCT01665053|Secondary|Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.||12 months|Intent-to-treat population|||percentage of participants|||Number
2650871|NCT01665053|Secondary|Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.||12 months|Intent-to-treat population|||percentage of participants|||Number
2650872|NCT01665053|Secondary|Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.||12 months|Intent-to-treat population|||percentage of participants|||Number
2650873|NCT01665053|Secondary|Percentage of Patients That Died at 12 Months.|The Death rate includes Cardiac- & Non-Cardiac Death.|12 months|Intent-to-treat population|||percentage of participants|||Number
2650874|NCT01665053|Secondary|Percentage of Participants With Non-Cardiac Death at 12 Month.||12 months|Intent-to-treat population|||percentage of participants|||Number
2650875|NCT01665053|Secondary|Percentage of Participants With Cardiac Death at 12 Month.||12 months|Intent-to-treat population|||percentage of participants|||Number
2650876|NCT01665053|Secondary|Percentage of Participants With Myocardial Infarction at 12 Month.|The MI rate includes: MI's related to the Target Vessel, MI's with unknown relationship to the Target Vessel and MI's not related to the Target Vessel.|12 months|Intent-to-treat|||percentage of participants|||Number
2650877|NCT01665053|Secondary|Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.|Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.|12 months|Intent-to-treat analysis|||percentage of participants|||Number
2650878|NCT01665053|Secondary|Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.|TVR overall includes: TVR PCI & TVR CABG.|12 months|Intent-to- Treat|||percentage of participants|||Number
2650879|NCT01665053|Secondary|Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.|The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) & TLR Coronary Artery Bypass Graft (CABG).|12 months|Intent-to-Treat population|||percentage of participants|||Number
2650880|NCT01665053|Primary|Percentage of Participants With Target Lesion Failure (TLF) at 12 Months|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.|12 months|The per protocol population was used for this analysis. Therefore the number of participants analyzed is not consistent with the numbers provided in participant flow module.|||percentage of participants|||Number
2650881|NCT01665040|Primary|Proportion of Subjects Satisfied With Treatment in a Sub-group Utilizing More Than 2 IPG Ports at 365 Days Post-IPG Implantation|Proportion of subjects in a sub-group utilizing more than 2 IPG ports at 365 Days post-IPG implantation satisfied with treatment, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.|365 days post permanent implantation|A sub-group of subjects utilizing more than 2 IPG ports at 365 Days post-IPG implantation|||Participants|||Count of Participants
2650882|NCT01665040|Primary|Proportion of Subjects Satisfied With Treatment at 90 Days Post-IPG Implantation|Proportion of subjects satisfied with treatment at 90 days post-IPG implantation, as measured by a 7-point Patient Satisfaction with Treatment (PSWT) questionnaire.|90-days post permanent implantation||||Participants|||Count of Participants
2650883|NCT01664975|Secondary|Median Survival Time||24 months||2016-12-31|12/2016||||
2650884|NCT01664975|Secondary|Overall Survival||up to the date of death (approximately 5 years)||2016-09-30|09/2016||||
2650885|NCT01664975|Secondary|Response Rate|21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles|every 6 weeks,up to completion of treatment(approximately 18 weeks )||2016-09-30|09/2016||||
2650886|NCT01664975|Primary|Progression-free Survival||up to end of follow-up-phase (approximately 24 months)||||participants|||Number
2650887|NCT01664949|Secondary|Change From Baseline in the Schirmer Test|The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.|||mm/5 minutes||Standard Deviation|Mean
2650888|NCT01664949|Secondary|Change From Baseline in Conjunctival Staining|Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). Conjunctival staining has 2 zones, nasal and temporal, which are added together to provide the total staining score. The eye with the higher score at Baseline was used for analysis. The higher the grade score, the worse the dry eye severity. A negative number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.|||score on a scale||Standard Deviation|Mean
2650889|NCT01664949|Secondary|Change From Baseline in Corneal Staining|Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The eye with the higher score at Baseline was used for analysis. The higher the grade score, the worse the dry eye severity. A negative number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.|||score on a scale||Standard Deviation|Mean
2650890|NCT01664949|Secondary|Change From Baseline in Tear Break-up Time (TBUT)|TBUT is the time in seconds for the tear film to visually break up after a complete blink. The average of 3 consecutive observations is reported for each participant. The longer it takes, the more stable the tear film. The eye with the shorter average TBUT at Baseline was used for analysis. A positive number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.|||seconds||Standard Deviation|Mean
2650891|NCT01664949|Primary|Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90|The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst). A negative number change from Baseline indicates improvement.|Baseline, Day 90|Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.|||score on a scale||Standard Deviation|Mean
2650892|NCT01664923|Secondary|Percentage of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. A treatment emergent AE defined as an event that emerged during treatment period (From first dose of study drug until end of open label phase [up to maximum duration of 65 months]) that was absent before treatment, or worsened during treatment period relative to pre-treatment state. AE included both serious and non- SAE. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An AE was considered related to study drug if event was assessed by investigator as probably or possibly related.|From first dose of study drug until the end of open label phase (up to maximum duration of 65 months)|Safety population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2650893|NCT01664923|Secondary|Best Overall Soft Tissue Response|Best overall soft tissue response is defined as partial response (PR) or complete response (CR) while on study treatment based on investigator assessment of target, nontarget, and new lesions using RECIST 1.1. Only participants in the metastatic population with measurable soft tissue disease (at least 1 target lesion identified per RECIST 1.1) at screening were included in the analysis. All percentages are based on number of participants with metastatic and measurable soft tissue disease at screening in each treatment group.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|All participants who were randomly assigned to study treatment and had metastatic and measurable soft tissue disease at screening.|||percentage of participants||95% Confidence Interval|Number
2650894|NCT01664923|Secondary|Quality of Life: Time to Degradation of Functional Assessment of Cancer Therapy - Prostate (FACT-P)|The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess patient function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score (0 to 156) with higher scores representing better quality of life. Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|Intent-to-treat population: all participants randomly assigned to study treatment.|||months||95% Confidence Interval|Median
2650895|NCT01664923|Secondary|Duration of Radiographic PFS|Duration of radiographic PFS was defined as the time from randomization to the earliest objective evidence of radiographic disease progression or death on study and was to be evaluated for participants with metastatic disease at study entry. Radiographic disease progression in bone was based on PCWG2 guidelines defined as at least 2 new lesions on bone scan. Radiographic disease progression in soft tissue on CT/MRI was based on RECIST 1.1. CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had radiographic progression at the time of analysis data cutoff were censored at the date of last radiographic assessment.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|All participants with metastatic disease at study entry and randomly assigned to study treatment.|||months||95% Confidence Interval|Median
2650896|NCT01664923|Secondary|Percentage of Participants With a PSA Response ≥ 50%|PSA response was defined as a reduction in PSA of at least 50% from baseline at any post baseline assessment confirmed by a second PSA assessment at least 3 weeks later.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|Evaluable intent-to-treat population: all participants randomly assigned to study treatment and had a baseline and at least 1 post baseline PSA measurement.|||percentage of participants||95% Confidence Interval|Number
2652459|NCT01652534|Secondary|Number Who Completed Medication as Randomized|Tolerability analysis as determined by the number of subjects completing each arm of the study.|week 4|participants who completed study to time of assessment|||Participants|||Count of Participants
2650897|NCT01664923|Secondary|Time to PSA Progression|PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment at least 3 weeks later. Participants not known to have had PSA progression were censored at the date of last PSA assessment.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|Intent-to-treat population: all participants randomly assigned to study treatment.|||months||95% Confidence Interval|Median
2650898|NCT01664923|Primary|Progression Free Survival (PFS)|PFS was defined as time from randomization to earliest objective evidence of prostate specific-antigen (PSA) progression, radiographic progression, or death on study. PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment. Radiographic progression in bone was based on The Prostate Cancer Clinical Trials Working Group (PCWG2) guidelines defined as at least 2 new lesions on bone scan. Radiographic progression in soft tissue on Computerized Tomography/Magnetic Resonance Imaging (CT/MRI) was based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). CT/MRI and bone scans were read locally by the same radiologist (or nuclear medicine physician for interpretation of bone scans) whenever possible. Participants not known to have had a PFS event at the time of the analysis data cutoff were censored at the date of last assessment.|From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.|Intent-to-treat population: all participants randomly assigned to study treatment.|||months||95% Confidence Interval|Median
2650899|NCT01664897|Secondary|Biomarker Expressions|Descriptive statistics will be used to summarize the expression of biomarkers and the concentrations of plasma erlotinib hydrochloride. The Wilcoxon rank sum test will be used to compare the expressions of biomarkers and concentrations of plasma erlotinib hydrochloride between patients with and without response.|Up to 30 days|Samples and data required for the above outcome measure were not done, therefore we cannot report any outcomes for the above outcome measure.||||||
2650900|NCT01664897|Primary|Event-free Survival|Time from date of treatment start until the date of first objective documentation of disease-relapse.|Up to 21 weeks||||Weeks||Full Range|Median
2650901|NCT01664897|Primary|Overall Survival|Time from date of treatment start until date of death due to any cause or last Follow-up.|Up to 97 weeks||||Weeks||Full Range|Median
2650902|NCT01664897|Primary|Incidence of Clinically Significant, Non-hematologic Grade 3 or 4 Toxicities at Least Possibly Related to Erlotinib Hydrochloride|Safety summaries will include tabulations in the form of tables and listings. The number of participants affected by treatment-emergent adverse events will be reported.|Up to 30 days||||Participants|||Count of Participants
2650903|NCT01664897|Primary|Participants With a Response|Overall Response is complete remission (CR) + CR with incomplete hematologic recovery (CRi) + Partial remission (PR) + Hematologic improvement (HI) + Morphologic Leukemia-Free State (MLF). (CR) is Bone marrow; </=5% blasts, no Auer rods or extramedullary disease and peripheral blood counts >/= 1.0x10^9/L Neutrophils, >/= 100x10^9/L platelets and no circulating blasts. (CRi), same as CR for bone marrow and <1.0x10^9/L neutrophils and < 100x10^9/L platelets in peripheral blood counts. PR is all CR criteria if abnormal prior to treatment except >/= 50%reduction in bone marrow blast but still > 5%. MLF is </=5% myeloblasts on bone marrow . HI response must be described by the number of positively affected cell lines..|Up to 3 months post-treatment||||Participants|||Count of Participants
2650904|NCT01664858|Secondary|Complications|Complications - investigational or procedural related only. All complications from all study procedures/investigations will be recorded and reported if they result in an extended length of stay or specific treatment.|3 years|||||||
2650905|NCT01664858|Secondary|Health-related Quality-of-life Measures (SAQ-UK; SF12; EQ-5D)|"Health-related quality-of-life (HRQoL) will be measured at baseline (in clinic), 6 months, 12 months, 2yrs and 3yrs (by post), using the following validated questionnaires:~Seattle Angina Questionnaire (SAQ) - UK version~SF12v2~EuroQol (EQ-5D)"|3 years|||||||
2650906|NCT01664858|Secondary|Cost Effectiveness Analysis|To assess the long term cost-effectiveness of the alternate diagnostic testing strategies, information from the trial will be used to update the economic model developed as part of the original CE-MARC trial. The model will use information from the trial, including on resource use, costs, HRQoL and other clinical outcomes (e.g. on unnecessary tests and MACE events), together with epidemiological, clinical and economic data from other sources to calculate costs and quality-adjusted life-years (QALYs) for patients. The economic analysis will use methods consistent with those recommended by the National Institute for Health and Clinical Excellence (NICE). Given the potential difference between diagnostic strategies in terms of mortality, the modelling will adopt a lifetime time horizon to capture any difference.|3 years|||||||
2650907|NCT01664858|Secondary|Positive Angiogram (by FFR) Rate for Each Strategy.|The Positive Angiogram rate will be determined from the proportion of patients in the relevant population who undergo an angiogram within 12 months of randomisation which yields a positive finding by FFR (or QCA where no FFR reading is undertaken)|12 months||||Participants|||Count of Participants
2650908|NCT01664858|Secondary|Major Adverse Cardiovascular Event (MACE)|"MACE is defined as one of the following:~Death due to cardiovascular cause (including type 3 MI) †~Myocardial infarction†~Unplanned revascularisation~Hospital admission for cardiovascular cause [ACS Troponin -ve, spontaneous myocardial infarction (Type 1)†, Myocardial infarction secondary to ischaemic imbalance (Type 2) †, Myocardial Infarction related to stent thrombosis (Type 4b) †, Arrhythmia, Stroke, Heart failure]. † As defined by the third universal definition of myocardial infarction."|at 12 months||||Participants|||Count of Participants
2650909|NCT01664858|Primary|Number of Participants With Unnecessary Invasive Coronary Angiography|"A negative FFR and positive non-invasive test (either 3T CMR or SPECT/CCT)~A negative FFR in a high pre-test risk (61-90%) patient that proceeds directly to invasive angiography in the NICE guidelines-based strategy arm~A negative FFR and a negative non-invasive test (either 3T CMR or SPECT/CCT) (i.e. a True Negative strategy result in which the imaging result was 'not believed' by the treating cardiologist)~An inconclusive non-invasive test result (either 3T CMR or SPECT/CCT) in which angiography had to be performed to make the diagnosis"|12 months||||Participants|||Count of Participants
2658568|NCT01597388|Primary|Left Ventricular Ejection Fraction||24 hours|The analysis population consisted of all participants who received at least one dose of AZD2014.|||% Left Ventricular Ejection Fraction||Standard Deviation|Mean
2650910|NCT01664806|Secondary|Histologic Evidence of Burn at the Umbilical Port Site Skin|Shave biopsy of skin at the umbilical port site after elective laparoscopic cholecystectomy will be performed. The secondary outcome is histologic evidence of burn at this port site.|1 day|A sample size of convenience for feasibility.|||participants|||Number
2650911|NCT01664806|Primary|Histologic Thermal Injury to Epigastric Port Site Skin|Shave biopsy of skin at the epigastric port site after elective laparoscopic cholecystectomy will be performed. The primary outcome is histologic evidence of burn at this port sites.|1 day|A sample size of convenience for feasibility.|||participants|||Number
2650912|NCT01664793|Secondary|Effectiveness Score|Two staff members from each site were surveyed as to usefulness/effectiveness of a list of strategies recommended in the toolkit to increase vaccination rates. Values (range = 1-100 with 1 being not at all effective and 100 being highly effective) were averaged and used as an effectiveness score for each strategy. The average value for each site was combined with all sites and averaged for each strategy. (actual range = 20.6-90.7).|End of February 2012||||units on a scale||Standard Deviation|Mean
2650913|NCT01664793|Primary|Primary Outcome|Influenza vaccination rates in each arm at the end of year 1|3/1/2011-2/29/2012||||participants vaccinated out of all|||Number
2650914|NCT01664741|Secondary|Relationship Between Change in Mu-opioid Receptor Binding Potential and Minnesota Nicotine Withdrawal Scale Score|Regression measure (β) between change in mu-opioid receptor binding potential between baseline scan and post-treatment scan and mean Minnesota Nicotine Withdrawal Scale (MNWS) score on Days 2 - 4 of the Clinical Research Unit stay. The MNWS is a self-report measure that consists of 14 nicotine withdrawal symptoms each rated on a 0 - 4 response scale for severity over the past 24 hours. Higher scores are indicative of greater nicotine withdrawal severity.|72 hours|This assessment was not done on the healthy non-smokers because they didn't have any nicotine craving.|||unitless|||Number
2650915|NCT01664741|Secondary|Relationship Between Change in Mu-opioid Receptor Binding Potential and Visual Analog Craving Scale Score|Regression measure (β) between change in mu-opioid receptor binding potential between baseline scan and post-treatment scan in the left amygdala and mean Craving Visual Analog Scale score on Days 2 - 4 of the Clinical Research Unit stay. Craving visual analog scale ranges from 0 (not at all) to 20 (worst ever).|72 hours|This assessment was not done on the healthy non-smokers because they didn't have any nicotine craving.|||unitless|||Number
2650916|NCT01664741|Primary|Change in Mu-opioid Receptor Binding Potential (BP) Between Baseline and Post-patch Scans|BP provides an estimate of the product of the density of available receptors (Bmax' or the receptor density Bmax less those occupied by endogenous transmitters) and the affinity [1/equilibrium dissociation constant (KD)]. We use reference tissue graphical analysis (RTGA) to obtain regional BP values using occipital lobe as a reference region. Negative BP change means means a decrease in the BP and positive BP change means an increase in the BP.|90 minutes||||ratio||Standard Error|Mean
2650917|NCT01664624|Secondary|Change From Baseline to Day 11 in 24-hour Average Plasma Glucose|Plasma glucose was measured by Continuous Glucose Monitoring System (CGMS). CGMS measures glucose every 5 minutes, starting in the fasting state 8 hour prior to the standardized breakfast (12 AM) until 16 hours after the breakfast. The average 24-hour plasma glucose concentration was calculated. Least squares means were obtained using an ANCOVA model with treatment as fixed effect, and Baseline 24-hour Glucose Measured by CGMS as a continuous covariate.|Baseline (Day -1) and Day 11, from 12 AM through 24 hours.|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.|||mg/dL||Standard Error|Least Squares Mean
2650918|NCT01664624|Secondary|Change From Baseline to Day 11 in AUC(0-8) of Appetite Sensation|"Appetite sensations were measured using a visual analog scale (VAS) questionnaire. Participants were asked to indicate their level of fullness, hunger, satiety, and prospective consumption (how much do you think you can eat?) on a 100 mm line ranging from Not at all (0 mm) to extremely (100 mm). Appetite sensation scores before and up to 8 hours after eating were plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of appetite sensation VAS score as a continuous covariate."|At Baseline and Day 11, every 30 minutes, starting 1 hour before eating until 8 hour after the meal.|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.|||mm*hr||Standard Error|Least Squares Mean
2650919|NCT01664624|Secondary|Change From Baseline in Postprandial AUC(0-8) of Insulin|The concentration of insulin in blood before and up to 8 hours after eating was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of insulin as a continuous covariate.|Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.|||pmol/L*hr||Standard Error|Least Squares Mean
2650920|NCT01664624|Secondary|Change From Baseline in Postprandial AUC(0-8) of C-peptide|The concentration of C-peptide in blood before and up to 8 hours after eating (postprandial) was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of C-peptide as a continuous covariate.|Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.|||ng/mL*hr||Standard Error|Least Squares Mean
2650921|NCT01664624|Secondary|Change From Baseline in AUC(0-8) of Postprandial Plasma Glucose|The concentration of glucose in blood before and up to 8 hours after eating (postprandial) was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an ANCOVA model with treatment as fixed effect, and baseline postprandial AUC (0-8) of plasma glucose as a continuous covariate.|Baseline and Day 11 at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).|Full analysis set. Only participants with data at both Baseline and post-baseline visits are included.|||mmol/L*hr||Standard Error|Least Squares Mean
2650922|NCT01664624|Primary|Change From Baseline in Postprandial Area Under the Curve From Time 0 to 8 Hours (AUC[0-8]) for Active Glucagon-like Peptide-1|The concentration of glucagon-like peptide-1 (GLP-1) in blood before and up to 8 hours after eating (postprandial) was plotted and the area under the curve calculated using the linear trapezoidal rule at Baseline and on Day 11. Least squares means of the change from Baseline to Day 11 were obtained using an analysis of covariance (ANCOVA) model with treatment as fixed effect, and Baseline postprandial AUC (0-8) of active GLP-1 as a continuous covariate.|Baseline and Day 11; samples were taken at -15 min and -5 min (pre-meal), and 15 min, 30 min, and 1, 2, 3, 4, 6, and 8 hours (post-meal).|Full analysis set defined as all randomized participants included in the safety analysis. Only participants with data at both Baseline and post-baseline visits are included.|||pmol/L*hr||Standard Error|Least Squares Mean
2650923|NCT01664559|Secondary|Post-insertion Provider Questionnaire|"The provider will be asked to fill out a multiple choice format questionnaire:~what level training are you?~which IUD was inserted?~what was the purpose of IUD placement?~what was the position of the uterus?~did the IUD placement process require cervical dilation?~were you able to complete the IUD insertion?~was there bleeding from the cervix that required more than 5 min to control?~were there any major complications with the IUD insertion?~did the patient take tylenol prior to leaving the office?"|Immediately after IUD placement, on average within 1 hour||||participants|||Number
2650924|NCT01664559|Secondary|Post-insertion Patient Questionnaire|"Questions assessed in multiple choice format:~Side effects~injection site pain~overall satisfaction with IUD insertion experience~would they still recommend IUD placement to a friend?~significant pain for which they desired acetaminophen prior to leaving the office?"|assessed at 15 minutes after IUD insertion||||participants|||Number
2650925|NCT01664559|Secondary|Nulliparous Patients - Subgroup Analysis|"The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.~Prior to injection of study drug, anticipated pain~Pain from study drug injection, measured immediately after injection~Pain from speculum insertion, measured immediately after insertion~Pain with tenaculum placement, measured immediately after placement~Pain with uterine sounding, measured immediately after removal of the sound~Pain at 5 minutes after placement of the intrauterine device~Pain at 15 minutes after placement of the intrauterine device"|immediately after each step (see description)||||cm||Inter-Quartile Range|Median
2650926|NCT01664559|Secondary|Pain Scores at Other Time Points During and After IUD Placement|"The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.~Prior to injection of study drug, anticipated pain~Pain from study drug injection, measured immediately after injection~Pain from speculum insertion, measured immediately after insertion~Pain with tenaculum placement, measured immediately after placement~Pain with uterine sounding, measured immediately after removal of the sound~Pain at 5 minutes after placement of the intrauterine device~Pain at 15 minutes after placement of the intrauterine device"|immediately after each step (see description)||||cm||Inter-Quartile Range|Median
2650927|NCT01664559|Primary|VAS (Visual Analogue Scale) Measurement of Pain|The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.|Pain with IUD placement, measured immediately after placement||||units on a scale||Inter-Quartile Range|Median
2650928|NCT01664533|Secondary|Percentage of Participants Who Developed Diarrhea||Up to 2 years|Safety analysis population: All participants who received at least 1 dose of erlotinib. Data was missing for 1 participant.|||percentage of participants||95% Confidence Interval|Number
2650929|NCT01664533|Secondary|Percentage of Participants Who Developed Rash||Up to 2 years|Safety analysis population: All participants who received at least 1 dose of erlotinib. Data was missing for 1 participant.|||percentage of participants||95% Confidence Interval|Number
2650930|NCT01664533|Secondary|Overall Survival|Overall survival was defined as the time from Baseline until death from any cause.|Up to 2 years||||months||95% Confidence Interval|Median
2650931|NCT01664533|Secondary|Best Overall Response|Reported are the percentage of participants with a best overall response of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the end of the study (up to 2 years)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol. Only participants with an evaluable response were included in the analysis.|||Percentage of participants||97.5% Confidence Interval|Number
2650932|NCT01664533|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first dose of erlotinib to disease progression or death from any cause, whichever occurred earlier. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter of target lesions recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 2 years)|Per-protocol population: All enrolled participants who started erlotinib therapy and did not violate the study protocol.|||Months||95% Confidence Interval|Median
2650933|NCT01664494|Secondary|Median Dose of Capecitabine|Median dose of capecitabine for treatment of metastatic colorectal cancer, adjuvant colon cancer, advanced gastric cancer, or metastatic breast cancer in this study was presented.|Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first|All enrolled participants were considered for this outcome measure.|||Milligrams||Full Range|Median
2650934|NCT01664494|Primary|Number of Participants With Routine Clinical Use of Capecitabine as Per the Line of Treatment|Choice of line of treatment in adjuvant and advanced or metastatic cancer for capecitabine was observed.|Approximately 3 years; or up to disease progression, death or stop of capecitabine treatment, whichever occurred first|All enrolled participants were considered for this outcome measure.|||Participants|||Number
2650935|NCT01664247|Secondary|Change From Baseline in Patient Reported Health-related Quality of Life Using the Short-Form 36 Health Survey Version 2 (SF-36®v2)|Change in subject's quality of life was evaluated using the Short-Form 36 Health Survey version 2 (SF-36®v2). Evaluations were performed at baseline and at the last treatment visit (week 26). SF-36 was assessed on a scale range of 0.65 to 80.73 for physical health and -8.81 to 81.65 for mental health respectively, where higher scores indicated a better quality of life. 0-100 scores from the SF-36 were converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 U.S. general population.|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 3 subjects PRO scores were missing at the baseline and did not contribute to the analysis.|||T-scores||Standard Deviation|Mean
2650936|NCT01664247|Secondary|Number of Adverse Events|Number of treatment emergent AEs (TEAEs) from week 0 to week 26 of the randomised treatment. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.|Weeks 0 - 26|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||events|||Number
2650937|NCT01664247|Secondary|Number of Hypoglycaemic Episodes|Number of confirmed hypoglycaemic episodes from week 0 to 26 weeks of randomised treatment. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes.|Weeks 0 - 26|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.|||events|||Number
2650938|NCT01664247|Secondary|Change From Baseline in Mean of the 8-point Profile|Change from baseline in mean of the 8-point profile after 26 weeks of randomised treatment.|Week 0, week 26|The FAS included all randomised subjects and missing data is imputed using LOCF. Mean values were missing for 11 subjects.|||mmol/L||Standard Deviation|Mean
2650939|NCT01664247|Secondary|Change From Baseline in 8-point Profile|The change from baseline in the 8-point SMPG profile after 26 weeks of randomised treatment. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.|Week 0, week 26|The FAS included all randomised subjects. The subjects not analysed were 12, 45, 46, 44, 44, 54, 56 and 21 subjects for before breakfast, 90 mins after breakfast, before lunch, 90 mins after start of lunch, before main evening meal, 90 mins after main evening meal, before bedtime and before breakfast the following day time points respectively.|||mmol/L||Standard Error|Least Squares Mean
2650940|NCT01664247|Secondary|Change From Baseline in Mean Pre-breakfast Measurements Used for Titration|Change from baseline after 26 weeks of treatment in the average of the pre-breakfast self measured plasma glucose (SMPG) measured on the day of the contact and the two days immediately prior to the contact. The least squares means presented are the estimated values after 26 weeks of treatment and the statistical analysis presents the treatment difference of the change from baseline values as the model is adjusted for baseline.|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 8 subjects the baseline values were missing|||mmol/L||Standard Error|Least Squares Mean
2650941|NCT01664247|Secondary|Number of Responders for HbA1c (Below 7.0 %)|Number of responders for HbA1c below 7.0%, after 26 weeks of randomised treatment.|After 26 weeks of randomised treatment.|The FAS included all randomised subjects and missing data was imputed using LOCF.|||percentage (%) of subjects|||Number
2650942|NCT01664247|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. For 6 subjects FPG values were missing.|||mmol/L||Standard Deviation|Mean
2650943|NCT01664247|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)|Change from baseline in HbA1c after 26 weeks of treatment|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
2650944|NCT01664130|Secondary|Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA|Percent measurement of biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.|Baseline and 12 months|participants who had a PSA value up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.|||percentage of participants||95% Confidence Interval|Number
2650945|NCT01664130|Secondary|Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA|Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.|Baseline and 8 months|participants who had a PSA value up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.|||percentage of participants||95% Confidence Interval|Number
2650946|NCT01664130|Secondary|Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA|Biochemical failure will be defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.|Baseline and 4 months|participants who had a PSA value up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.|||percentage of participants||95% Confidence Interval|Number
2650947|NCT01664130|Secondary|Percentage of Participants With Biochemical Relapse Free Survival as Measured by Serum PSA|Percentage of Participants with biochemical failure. Biochemical failure is defined as a rise in PSA of 2.0 ng/dl above the post-treatment nadir.|Baseline and 1.5 months|participants who had a PSA values up to the reporting time interval. Not every patient had all of the PSA values collected due to missed test visits.|||percentage of participants||95% Confidence Interval|Number
2650948|NCT01664130|Secondary|Quality of Life as Assessed by Change in AUA Scores|Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.|Baseline and 12 months|Participants that were able to complete the questionnaire at specific time point.|||score on a scale||Full Range|Median
2651660|NCT01660451|Secondary|Overall Survival (OS)|OS was defined as the time (in days) from the date of first administration of study treatment to death due to any cause.|Baseline up to the last patient has completed the 16 weeks of treatment|FAS included all patients assigned to study treatment.|||days||95% Confidence Interval|Median
2650949|NCT01664130|Secondary|Quality of Life as Assessed by Change in AUA Scores|Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.|Baseline and 8 months|Participants that were able to complete the questionnaire at specific time point.|||score on a scale||Full Range|Median
2650950|NCT01664130|Secondary|Quality of Life as Assessed by Change in AUA Scores|Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.|Baseline and 4 months|Participants that were able to complete the questionnaire at specific time point.|||score on a scale||Full Range|Median
2650951|NCT01664130|Secondary|Quality of Life as Assessed by Change in AUA Scores|Quality of life (QOL) as assessed by changes in AUA scores ranging between 0 to 35, with higher scores indicating a worse clinical assessment.|Baseline and 1.5 months|Participants that were able to complete the questionnaire at specific time point.|||score on a scale||Full Range|Median
2650952|NCT01664130|Secondary|Quality of Life as Assessed by EPIC Scores|Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.|Baseline and 12 months|Participants that were able to complete the questionnaire at specific time point.|||score on a scale||Standard Deviation|Mean
2650953|NCT01664130|Secondary|Quality of Life as Assessed by EPIC Scores|Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.|Baseline and 8 months|Participants that were able to complete the questionnaire at specific time point.|||score on a scale||Standard Deviation|Mean
2650954|NCT01664130|Secondary|Quality of Life as Assessed by EPIC Scores|Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.|Baseline and 4 months|Participants that were able to complete the questionnaire at specific time point.|||score on a scale||Standard Deviation|Mean
2650955|NCT01664130|Secondary|Quality of Life as Assessed by EPIC Scores|Quality of life (QOL) from baseline as assessed by scores of the EPIC Questionnaire. Scores for each domain (urinary incontinence, bowel, sexual, hormonal) range from 0-100, with higher scores indicating better clinical assessment.|Baseline and 1.5 months|Participants that were able to complete the questionnaire at specific time point.|||score on a scale||Standard Deviation|Mean
2650956|NCT01664130|Primary|Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0|Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0|12 months|All patients that received treatment|||Participants|||Count of Participants
2650957|NCT01664130|Primary|Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0|Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0|8 months|Per protocol|||Participants|||Count of Participants
2650958|NCT01664130|Primary|Number of Patients With Treatment Related GI and GU Toxicity as Assessed by the NCI CTCTAE Version 4.0|Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0|4 months|Per protocol|||Participants|||Count of Participants
2650959|NCT01664130|Primary|Number of Patients With Treatment Related GI and/or GU Toxicity as Assessed by the NCI CTCTAE Version 4.0|Number of patients with excessive GI and/or GU toxicity, defined as a grade 3 GU toxicity rate of ≥15% according to the NCI CTCTAE version 4.0|1.5 months|All patients that received treatment|||Participants|||Count of Participants
2650960|NCT01664117|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An Any Adverse Events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|At the time of change of treatment (to the current treatment)|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
2650961|NCT01664117|Secondary|Number of Participants With Adverse Events Leading to a Change of Treatment|An Adverse Event was considered as any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Adverse events were collected as a reason for the change to monotherapy.|At the time of change of treatment|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
2650962|NCT01664117|Secondary|Number of Participants Falling Within Reference Values For C-reactive Protein and Erythrocyte Sedimentation Rate by Biologic Agent in Monotherapy at the Time of the Study|Participants who received biologic agent in monotherapy at the time of the study were assessed for C-reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR).|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
2650963|NCT01664117|Secondary|Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study|Participants who received biologic agent in monotherapy at the time of the study were assessed for a number of painful joints (NPJ) and swollen joints (NSJ).|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||Number of joints||Standard Deviation|Mean
2650964|NCT01664117|Secondary|Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score|Mean score of categorization (remission/low activity and moderate/high activity) of DAS28 index, CDAI index, and SDAI index was recorded for participants who received biologic agent in monotherapy at the time of the study .|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
2651828|NCT01658150|Secondary|Number of Participants With Suicidal Acknowledgments|Number of participants with Suicidal acknowledgements based on the Columbia Suicide Severity Rating Scales (C-SSRS) - Full range from 0 (low intensity suicidal ideation to 9 (high intensity suicidal ideation).|up to 4 weeks||||Participants|||Count of Participants
2650965|NCT01664117|Secondary|Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study|Mean score of DAS28 index, CDAI index, and SDAI index were recorded for participants who received biologic agent in monotherapy at the time of the study.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||Units on a scale||Standard Deviation|Mean
2650966|NCT01664117|Secondary|Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent)||At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n' signifies the number of participants analyzed at specified time point.|||Number of sDMARD/bDMARDs/Other||Standard Deviation|Mean
2650967|NCT01664117|Secondary|Mean Time of bDMARD Monotherapy Started at the Time of the Study Since Onset of RA||At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n' signifies the number of participants analyzed at specified time point.|||years||Standard Deviation|Mean
2650968|NCT01664117|Secondary|Number of Participants Who Received Tocilizumab, Anti-Tumour Necrosis Factor and Other as a Monotherapy at the Time of the Study|Participants who received tocilizumab, Anti-tumour necrosis factor (TNF) and Other treatment of monotherapy were reported.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
2650969|NCT01664117|Secondary|Number of Participants With Reasons for Starting Current Biologic Monotherapy|The reasons for changing current biologic treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
2650970|NCT01664117|Secondary|Number of Participants Received Other Concomitant Treatments With the Current bDMARD Monotherapy|Other treatments included corticosteroids, NSAIDs and corticosteroid + NSAID.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
2650971|NCT01664117|Secondary|Number of Participants Received Current bDMARD Treatment at the Time of the Study|Current bDMARD treatment included etanercept, infliximab, adalimumab, abatacept, tocilizumab, rituximab and certolizumab.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
2650972|NCT01664117|Secondary|Number of Participants Treated With Concomitant Medications Before the Study|Participants received concomitant medications (corticosteroids, non-steroidal anti-inflammatory drugs [NSAID], and other treatment) before the study were presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
2650973|NCT01664117|Secondary|Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment|Median time in months taking the Biologic Agent in monotherapy before the study was presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n' signifies the number of participants analyzed at specified time point.|||Months||Full Range|Median
2650974|NCT01664117|Secondary|Number of Participants Discontinued the Previous Treatment and Started the Study Treatment|The reasons for changing the previous sDMARD, sDMARD+ bDMARD or bDMARD treatment and starting the study treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement, and other.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
2650975|NCT01664117|Secondary|Number of Participants Received sDMARD, sDMARD+ bDMARD or bDMARD Immediately Before the Study Treatment||At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
2650976|NCT01664117|Secondary|Number of sDMARD and bDMARDs Received Before the Study Treatment (bDMARD Monotherapy)|Number of sDMARD and bDMARDs received by Participants before the study was presented|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n' signifies the number of participants analyzed at specified time point.|||Number of sDMARD/bDMARD||Standard Deviation|Mean
2650977|NCT01664117|Secondary|Number of Participants With Changing the Previous sDMARD/ bDMARD|Any reasons for changing the previous sDMARD/bDMARD treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other. There may be more than one reason for changing sDMARD/ bDMARD per participant.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n’ represents the number of participants analyzed at a specified time point.|||Participants|||Number
2650978|NCT01664117|Secondary|Mean Time Between the Last sDMARD and bDMARD Received at Visit 1|Mean time between the last sDMARD and bDMARD received at Visit 1 was presented in months.|At Visit 1|Analysis Population included all enrolled participants who met the inclusion criteria. ‘n' signifies the number of participants analyzed at specified time point.|||Months||Standard Deviation|Mean
2650979|NCT01664117|Secondary|Number of Participants Who Received Each bDMARD Before the Study|Number of participant who received bDMARD (etanercept, infliximab, golimumab, adalimumab, abatacept, tocilizumab, rituximab) before the study was reported in at Visit 1.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
2650980|NCT01664117|Secondary|Number of Participants Prescribed First bDMARD Before the Study|Number of participants prescribed first bDMARD before the study was presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||Participants|||Number
2650981|NCT01664117|Secondary|Number of Participants Who Received Last sDMARD Prescribed Before the Study|Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, leflunomide, ciclosporin, methotrexate, and leflunomide + methotrexate.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||participants|||Number
2650982|NCT01664117|Secondary|Number of Participants Who Received Each sDMARD Before The Study|Number of participants who previously received sDMARDs before the study in at Visit 1 was reported. sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, chloroquine, leflunomide, ciclosporin, methotrexate, and chlorambucil medications.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||Participants|||Number
2658569|NCT01597388|Primary|Clinically Important Changes in Clinical Chemistry Parameters||Up to 12 Months|The analysis population consisted of all participants who received at least one dose of AZD2014.|||Participants|||Number
2650983|NCT01664117|Secondary|Mean Time Between Diagnosis and Prescription of First Synthetic Disease-Modifying Antirheumatic Drug or First Biologic Disease-Modifying Antirheumatic Drug|Mean time in months at Visit 1 between diagnosis and prescription of first sDMARD/ first bDMARD was presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria. ‘n’ = number of participants prescribed with first sDMARD or bDMARD.|||Months||Standard Deviation|Mean
2650984|NCT01664117|Secondary|Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study|Number of participants prescribed with first synthetic disease-modifying antirheumatic drug therapy (sDMARD) in monotherapy and in a combination before the study was presented.|At Visit 1|Analysis Population included all enrolled participants who met the screening criteria.|||Participants|||Number
2650985|NCT01664117|Primary|Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1|SDAI is divided into 4 categories as: remission (<3.3), low activity (3.3-11), moderate activity (11-26) and high activity (>26).|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
2650986|NCT01664117|Primary|Mean Score on Simple Disease Activity Index at Visit 1|Simple Disease Activity Index (SDAI) is calculated by sum of number of painful joint and swollen joint count, patient and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligrams per deciliter (mg/dL). SDAI total score ranges from 0 to 86, where higher scores indicates greater affect due to disease activity.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Scores on a scale||Standard Deviation|Mean
2650987|NCT01664117|Primary|Number of Participants With Clinical Disease Activity by Categorization at Visit 1|CDAI is divided into 4 categories as: remission <2.8, low activity 2.8-10, moderate 10-22 and high>22.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
2650988|NCT01664117|Primary|Mean Score on Clinical Disease Activity Index at Visit 1|Clinical disease activity index (CDAI) of participants is a composite index that is calculated as the sum of number of painful joint, number of swollen joint, patient's VAS (0-10 cm) assessment, physician global VAS assessment (0-10 cm). The CDAI score ranges from 0 to 76, where lower scores indicate less disease activity.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Scores on a scale||Standard Deviation|Mean
2650989|NCT01664117|Primary|Number of Participants With Disease Activity Score by Categorization at Visit 1|DAS28 is divided into 4 categories as: remission <2.6, low activity 2.6-3.2, moderate 3.2-5.1 and high >5.1.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
2650990|NCT01664117|Primary|Mean Score on Disease Activity Score Based on 28-Joints Count at Visit 1|Disease activity score (DAS) 28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Units on a scale||Standard Deviation|Mean
2650991|NCT01664117|Primary|Number of Participants With Joint Damage at Visit 1|Number of participants with joint damage is recorded as yes and no.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
2650992|NCT01664117|Primary|Patient Pain Visual Analog Scale Score at Visit 1|"Participants assessed their pain using a 0 to 10 horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 and is described as no pain and the right-hand extreme equals 10 as unbearable pain"|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. Out of 209 participants, 207 were analysed for patient pain visual analog scale.|||Units on a scale||Standard Deviation|Mean
2650993|NCT01664117|Primary|Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1|The test for C-reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Erythrocyte sedimentation rate (ESR) is a laboratory test that provides a non-specific measure of inflammation. A higher rate is consistent with inflammation.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
2650994|NCT01664117|Primary|Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies|Rheumatoid Factor (RF) is the auto antibody directed against Immunoglobulin G and its concentration is observed in human serum or plasma. Anti-Cyclic Citrullinated Protein Antibodies (Anti-CCP) antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. n =number of evaluated participants|||Participants|||Number
2650995|NCT01664117|Primary|Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1|Biochemistry parameters is considered as one of the component of clinical characteristics. Biochemistry parameters included alanine amino transferase (ALT), aspartate amino transferase (AST), triglycerides, total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and total lipids.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. 'n' =number of evaluated participants|||Participants|||Number
2650996|NCT01664117|Primary|Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1|Hematology parameters are considered as one of the component of clinical characteristics. Hematology parameters included white blood cells (WBC), platelets, red blood cells (RBC), hemoglobin, hematocrit, neutrophils, basophils, eosinophils, lymphocytes, monocytes.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. n =number of evaluated participants|||Participants|||Number
2651766|NCT01658943|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for adverse events are included in this summary.|||Participants|||Number
2650997|NCT01664117|Primary|Patient's Global Assessment of Disease Activity at Visit 1|"Patient global assessment of disease activity visual analog scale is assessed using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity)."|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Units on a scale||Standard Deviation|Mean
2650998|NCT01664117|Primary|Physician's Global Assessment of Disease Activity at Visit 1|"The Physician's global assessment of disease activity is assessed using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity)."|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Units on a scale||Standard Deviation|Mean
2650999|NCT01664117|Primary|Mean Number of Painful and Swollen Joints at Visit 1|Participants were assessed for painful and swollen joints at Visit 1. Painful joint is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Number of joints||Standard Deviation|Mean
2651000|NCT01664117|Primary|Number of Participants With Extra-articular Manifestations at Visit 1|Extra-articular manifestations (EAMs) are a component of of clinical characteristics EAMs are symptoms and diseases that occur in parts of the body other than joints. These included the presence of amyloidosis (rare disease that results from the buildup of misfolded proteins), anemia (deficiency of red cells in the blood), heart complications, lung complications, rheumatoid nodules (local swelling), felty's syndrome (presence of rheumatoid arthritis, an enlarged spleen, and an abnormally low white blood cell count), and secondary Sjogren's (an autoimmune disorder that damages moisture-producing glands, making it difficult to produce saliva and tears). Participants were assessed into categories with extra-articular Manifestations as yes, no and missing nos.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
2651001|NCT01664117|Primary|Number of Participants With Co-morbidities|Co-morbidity is a component of clinical characteristics It included stroke, heart failure (grades I, II, III or IV), ischemic heart disease, hypertension, dyslipidemia, osteoporosis, interstitial lung disease, chronic obstructive pulmonary disease (COPD), depression, diabetes mellitus, liver disease, serious infections, tuberculosis, hematological malignancies, solid tumors and others. Participants were assessed into categories with associated co-morbidities as yes and no.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
2651002|NCT01664117|Primary|Number of Participants With Family History of Rheumatoid Arthritis|Family history is a component of clinical characteristics. Participants who had a family history of rheumatoid arthritis is recorded as yes/no. Also, family history related to parents, siblings, aunts and uncles, grandparents, or other is recorded.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
2651003|NCT01664117|Primary|Mean Time of Onset of Rheumatoid Arthritis|Onset of rheumatoid arthritis is a component of clinical characteristics.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Years||Standard Deviation|Mean
2651004|NCT01664117|Primary|Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking )|Smoking-habit included years of smoking/quit smoking is reported for participants.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. 'n' = number of evaluated participants|||Years||Standard Deviation|Mean
2651005|NCT01664117|Primary|Smoking-habit for Smokers or Ex-smokers (Packs in Years)|Smoking-habit included number of pack per years is reported.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria. n = number of evaluated participants|||Years||Standard Deviation|Mean
2651006|NCT01664117|Primary|Number of Participants With Smoking Habits|Smoking habits is a component of socio-demographic characteristics. Participants' smoking status is recorded as non-smoker, smoker, and ex-smoker at Visit 1.|At Visit 1|Analysis population included all enrolled participants who met the screening criteria.|||Participants|||Number
2651007|NCT01664117|Primary|Number of Participants With Level of Education Completed|Level of education completed is a component of socio-demographic characteristics. It is recorded as cannot read, no formal education, primary education or equivalent, general secondary education, vocational education, and higher education or equivalent. Data were collected at study entry (Single visit study)|At Visit 1 (Single visit study)|Analysis population included all enrolled participants who met the screening criteria|||Participants|||Number
2651008|NCT01664104|Secondary|Correlation Coefficient Between BMI at the Start of TCZ Treatment and VAS Fatigue at Month 6|Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||correlation coefficient|||Number
2651009|NCT01664104|Secondary|Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and Change From Baseline in Morning Stiffness According to VAS at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, < 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, > 240 minutes, and the whole day. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||correlation coefficient|||Number
2651767|NCT01658904|Secondary|Evaluate the Effects of the Addition of Carfilzomib (CFZ) in the Early Post-Pre-autologous Hematopoietic Cell Transplantation (AHCT) Period on the Response Rate at Day 100 Post-AHCT||Day 100 post-AHCT|This outcome measure was not done because the study was closed prematurely because the investigator left the National Institutes of Health.||||||
2651010|NCT01664104|Secondary|Correlation Coefficient Between BMI at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||correlation coefficient|||Number
2651011|NCT01664104|Secondary|Correlation Coefficient Between Change From Baseline in CRP (mg/dL) at the Start of TCZ Treatment and Change From Baseline in VAS Fatigue at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||correlation coefficient|||Number
2651012|NCT01664104|Secondary|Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and VAS Fatigue at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||correlation coefficient|||Number
2651013|NCT01664104|Secondary|Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and HAQ-DI (0-3) at Month 6|CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0= without any difficulty to 3= unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||correlation coefficient|||Number
2651014|NCT01664104|Secondary|Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6|The test for CRP is laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from −1 to +1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||correlation coefficient|||Number
2651015|NCT01664104|Secondary|BMI at the Start of TCZ Treatment by Morning Stiffness at Month 6|Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and > 30 minutes.|Baseline|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.|||Kg/m^2||Standard Deviation|Mean
2651016|NCT01664104|Secondary|CRP at the Start of TCZ Treatment by Morning Stiffness at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and > 30 minutes.|Baseline|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for this outcome measure and number analyzed = participants with available data for specified category.|||mg/dL||Standard Deviation|Mean
2651017|NCT01664104|Secondary|Percentage of Participants by Duration of Morning Stiffness|Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, < 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, > 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed.|Month 3 and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
2658570|NCT01597388|Primary|Clinically Important Changes in Haematology Parameters||Up to 12 Months|The analysis population consisted of all participants who received at least one dose of AZD2014.|||Participants|||Number
2651018|NCT01664104|Secondary|Percentage of Participants With and Without Morning Stiffness|"Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria:~Presence of participant's joints stiff when woke up that day, measured as yes (stiffness present) or no (stiffness not present);~Duration of morning stiffness, measured by ticking 1 of the six categories: < 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, > 240 minutes, and the whole day;~Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 mm = no stiffness to 100 mm = maximum stiffness.~'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed."|Month 3 and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
2651019|NCT01664104|Secondary|Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6|DAS28 scale ranges from 0 to 10, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 and SJC28 = tender joint and swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, CRP = serum concentration of C-reactive protein. A score of < 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100mm = extremely active arthritis. A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.|Baseline|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for this outcome measure and number analyzed = participants with available data for specified category.|||kilogram per meter square (Kg/m^2)||Standard Deviation|Mean
2651020|NCT01664104|Secondary|CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. DAS28 is calculated as follows: DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, A score of < 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL). A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.|Baseline|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for this outcome measure and number analyzed = participants with available data for specified category.|||mg/dL||Standard Deviation|Mean
2651021|NCT01664104|Secondary|Change From Baseline in ESR at Month 3 and Month 6|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A decrease in the level indicates reduction in inflammation and therefore improvement. Change from baseline = ESR level at Month X - ESR level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mm/hr||Standard Deviation|Mean
2651022|NCT01664104|Secondary|Change From Baseline in CRP at Month 3 and Month 6|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change from baseline = CRP level at Month X - CRP level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mg/dL||Standard Deviation|Mean
2651023|NCT01664104|Secondary|Time to Steroid Dose Withdrawal|"Steroids that met the criteria for concomitant medications were selected. The time to steroid dose withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion."|Baseline up to Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||months||Inter-Quartile Range|Median
2651024|NCT01664104|Secondary|Time to Steroid Dose Reduction|"Steroids that met the criteria for concomitant medications were selected. The time to steroid dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than one steroid dose reduction, only the first dose reduction was considered."|Baseline up to Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||months||Inter-Quartile Range|Median
2651025|NCT01664104|Secondary|Percentage of Participants by Reason for DMARD Withdrawal During the Study|"DMARDs that met the criteria for concomitant medications were selected. All treatments with DMARDs interrupted after the first TCZ infusion were selected."|Baseline up to Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
2651026|NCT01664104|Secondary|Time to DMARD Dose Withdrawal|"DMARDs that met the criteria for concomitant medications were selected. The time to DMARD withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion."|Baseline up to Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||months||Inter-Quartile Range|Median
2651027|NCT01664104|Secondary|Time to DMARD Dose Reduction|"DMARDs that met the criteria for concomitant medications were selected. The time to DMARD dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than 1 DMARD dose reduction, only the first dose reduction was considered."|Baseline up to Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||months||Inter-Quartile Range|Median
2651028|NCT01664104|Secondary|Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6|Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. DAS28 score is a measurement of RA activity on 0 to 10 scale and calculated as DAS28= 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28= tender joint count on 28 units, SJC28= swollen joint count on 28 units, CRP= serum concentration of C-reactive protein (after converting units to mg/dL), PGH= patient's global assessment of disease activity measured on a 100 mm VAS, where 0 mm= managing very well and 100 mm= managing very poorly. Good responders experienced change (chg) from baseline (BL) of >1.2 with DAS28 score ≤ 3.2, moderate responders experienced chg from BL >1.2 with DAS28 score > 3.2 to ≤ 5.1 or a chg from BL > 0.6 to ≤ 1.2 with DAS28 score of ≤ 5.1. No responders experienced chg from BL < 0.6 regardless initial DAS28 score or > 0.6 to ≤ 1.2 with DAS28 score of > 5.1.|Month 3 and Month 6|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.|||percentage of participants|||Number
2651029|NCT01664104|Secondary|Percentage of Participants With Clinically Meaningful Improvement in HAQ-DI|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity. HAQ-DI clinically meaningful improvement is defined as decrease in HAQ total score from baseline of greater or equal to 0.22 points.|Month 3 and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
2651030|NCT01664104|Secondary|Change From Baseline to Month 6 in Participant Assessment of Morning Stiffness|The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
2651031|NCT01664104|Secondary|Change From Baseline to Month 6 in Participant Assessment of Fatigue|Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.|Baseline and Month 6|All enrolled participants evaluable for the primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
2651032|NCT01664104|Secondary|Change From Baseline to Month 6 in HAQ-DI Score|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do.Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity.|Baseline and Month 6|All enrolled participants evaluable for the primary objective with available data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2651033|NCT01664104|Secondary|Change From Baseline to Month 6 in Patient's Assessment of Pain|Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
2651034|NCT01664104|Secondary|Change From Baseline to Month 6 in PhGH|The PhGH was evaluated using a 100 mm VAS where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. Higher scores indicated increased level of disease.|Baseline and Month 6|All enrolled participants evaluable for the primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
2651035|NCT01664104|Secondary|Change From Baseline to Month 6 in PGH|The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well and 100 mm = managing very poorly.|Baseline and Month 6|All enrolled participants evaluable for the primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
2651036|NCT01664104|Secondary|Change From Baseline to Month 6 in SJC|SJC was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at baseline and at Month 6. No swelling = 0 and swelling = 1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||swollen joints||Standard Deviation|Mean
2651037|NCT01664104|Secondary|Change From Baseline to Month 6 in TJC|TJC was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at baseline and at Month 6. No tenderness = 0 and tenderness = 1.|Baseline and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||tender joints||Standard Deviation|Mean
2651059|NCT01664104|Secondary|Erythrocyte Sedimentation Rate (ESR) at Baseline|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hour). A decrease in the level indicates reduction in inflammation and therefore improvement.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mm/hour||Standard Deviation|Mean
2651060|NCT01664104|Secondary|Swollen Joint Count (SJC) at Baseline|SJC was determined by examining 28 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline; no swelling = 0 and swelling = 1.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||swollen joints||Standard Deviation|Mean
2651038|NCT01664104|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment|ACR20, 50, 70 or 90 response = an improvement of ≥20%, ≥50%, ≥70% or ≥90% respectively, as compared to baseline in TJC28 and SJC28, and 20/50/70/90%, improvement in at least 3 of 5 following measures: Patient's Assessment of Pain over previous 24 hours, PGH, PhGH, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on joint assessment form at baseline; no tenderness = 0 and tenderness = 28, no swelling = 0 and swelling = 28, respectively. HAQ measures functional status (disability) and health-related QoL with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0= without difficulty to 3= unable to do. Patient's assessment of pain assessed using VAS; 0 mm = no pain, 100 mm = unbearable pain; PGH and PhGH, assessed using VAS; 0 mm = no disease activity, 100 mm = maximum disease activity.|Month 3 and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
2651039|NCT01664104|Secondary|Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6|CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of > 22.0 represents high (or severe) disease activity.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.|||percentage of participants|||Number
2651040|NCT01664104|Secondary|Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6|SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity, ≤ 26.0 represents moderate disease activity, and > 26.0 represents high (or severe) disease activity.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.|||percentage of participants|||Number
2651041|NCT01664104|Secondary|Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6|DAS28 score is a measurement of RA activity on a 0 to 10 scale and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly. Higher scores represent greater disease activity. A score of < 2.6 represents clinical remission, a score of ≥ 2.6 and ≤ 3.2 represents low disease activity, a score of >3.2 and ≤ 5.1 represents moderate disease activity, and a score of > 5.1 represents high (or severe) disease activity.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for this outcome and number analyzed = participants with available data for specified category.|||percentage of participants|||Number
2651042|NCT01664104|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6|The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of > 22.0 represents high (or severe) disease activity. Change from baseline = CDAI score at Month X - CDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2651043|NCT01664104|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6|SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity , ≤ 26.0 represents moderate disease activity, and > 26.0 represents high (or severe) disease activity. Change from baseline = SDAI score at Month X - SDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2651044|NCT01664104|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6|DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly (√ = square root). A score of < 2.6 represents clinical remission, a score of greater than or equal to (≥) 2.6 and less than or equal to (≤) 3.2 represents low disease activity, a score of > 3.2 and ≤ 5.1 represents moderate disease activity and a score of > 5.1 represents high (or severe) disease activity. Change from baseline = DAS28 at Month X - DAS28 at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.|Baseline, Month 3, and Month 6|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2651045|NCT01664104|Secondary|Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline||Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
2651046|NCT01664104|Secondary|Percentage of Participants With TCZ Reintroduction|"The percentage of participants with at least one TCZ reintroduction was reported as Yes. Participants with unknown TCZ reintroduction were set to No."|Baseline up to Month 6|All enrolled participants evaluable for primary objective.|||percentage of participants|||Number
2651047|NCT01664104|Secondary|Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation||Baseline up to Month 6|All enrolled participants evaluable for primary objective who discontinued TCZ.|||percentage of participants|||Number
2651048|NCT01664104|Secondary|Percentage of Participants With TCZ Infusion Interruption|"The percentage of participants with at least one infusion interruption was reported as Yes. Participants with unknown infusion interruption were set to No."|Baseline up to Month 6|All enrolled participants evaluable for primary objective.|||percentage of participants|||Number
2651049|NCT01664104|Secondary|Time in Days Elapsed Between TCZ Infusions|The time elapsed in days between TCZ infusions was calculated as the difference between the date of TCZ infusion and the date of the previous administration.|Baseline up to Month 6 (assessed retrospectively and prospectively at each administration [approximately 1 month apart] up to administration 8|All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.|||days||Inter-Quartile Range|Median
2651050|NCT01664104|Secondary|Percentage of Participants by Number of TCZ Dose Modifications Per Participant|The number of TCZ dose modifications per participant was calculated as the number of times that the participant changed the prescribed dose with respect to the dose planned at enrollment/previous administration. If the participant did not change the prescribed dose, the values were set at missing.|Baseline up to Month 6|All enrolled participants evaluable for primary objective.|||percentage of participants|||Number
2651051|NCT01664104|Secondary|Number of Participants With TCZ Dose Change According to the Reason for Change|Number of participants with TCZ dose change (increase or decrease with respect to starting dose) was reported by reason for change.|Baseline up to Month 6|All enrolled participants evaluable for the primary objective and had TCZ dose modification.|||participants|||Number
2651052|NCT01664104|Secondary|Percentage of Participants by Duration of Morning Stiffness at Baseline|Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, less than (<) 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, greater than (>) 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it.|Baseline|All enrolled participants evaluable for primary objective.|||percentage of participants|||Number
2651053|NCT01664104|Secondary|Percentage of Participants With Anti-Citrullinated Cyclic Peptide at Baseline||Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
2651054|NCT01664104|Secondary|Percentage of Participants With Positive Rheumatoid Factor (RF) at Baseline|RF is the auto antibody directed against immunoglobulin G and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter is considered positive.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
2651055|NCT01664104|Secondary|Percentage of Participants With Previous RA-Related Surgical Procedures at Baseline||Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
2651056|NCT01664104|Secondary|Percentage of Participants With Evidence of Structural Joint Damage at Baseline||Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
2651057|NCT01664104|Secondary|Percentage of Participants With Presence of Extra-Articular Systemic Features of RA at Baseline|Extra-articular systemic features referred to anemia, fatigue as well as a wide range of co-morbidities such as osteoporosis and other iatrogenic complications. Percentage of participants with any of the extra-articular systemic feature are reported.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||percentage of participants|||Number
2651058|NCT01664104|Secondary|C-Reactive Protein (CRP) at Baseline|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2651061|NCT01664104|Secondary|Tender Joint Count (TJC) at Baseline|TJC was determined by examining 28 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline; no tenderness = 0 and tenderness = 1.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||tender joints||Standard Deviation|Mean
2651062|NCT01664104|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Baseline|The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life (QoL). It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all questions and ranges from 0 to 3, where higher scores represent higher disease activity.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2651063|NCT01664104|Secondary|Participant Assessment of Fatigue Using VAS at Baseline|Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
2651064|NCT01664104|Secondary|Participant Assessment of Morning Stiffness Using VAS at Baseline|The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
2651065|NCT01664104|Secondary|Physician Global Assessment of Disease Activity (PhGH) Using VAS at Baseline|The PhGH was measured on a 100 mm VAS, where 0 mm = no arthritis activity to 100 mm = extremely active arthritis.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
2651066|NCT01664104|Secondary|Patient Global Assessment of Disease Activity (PGH) Using VAS at Baseline|The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well to 100 mm = managing very poorly.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
2651067|NCT01664104|Secondary|Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline|Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.|Baseline|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||mm||Standard Deviation|Mean
2651068|NCT01664104|Secondary|Time Elapsed From Diagnosis of RA|Time elapsed from diagnosis of RA in years was calculated as the (difference between the date of enrollment visit and the date of first diagnosis of RA) divided by 365.25.|Baseline (assessed retrospectively)|All enrolled participants evaluable for primary objective with available data for this outcome measure.|||years||Full Range|Median
2651069|NCT01664104|Secondary|Percentage of Participants Starting TCZ After Inadequate Response (IR) to a Biologic Treatment or After Intolerance or IR to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)|"Participants with at least 1 treatment with biologic agent not equal missing and which is not ongoing or with a stop date lower or equal to first TCZ administration had IR to biologic treatment. Participants with at least 1 treatment with DMARDs with a stop date lower or equal to first TCZ administration had IR to DMARDs. Participants with a biologic and DMARDs interruption or with a biologic interruption and ongoing treatment with DMARDs were classified in IR to biologic group. Participants with DMARDs interruption or ongoing DMARDs and adding TCZ without a biologic interruption were classified in the DMARDs intolerance and/or IR group."|Baseline|All enrolled participants evaluable for primary objective.|||percentage of participants|||Number
2651070|NCT01664104|Secondary|Percentage of Participants by TCZ Dose at Month 6|TCZ dose at Month 6 was calculated over the total number of participants evaluable for the primary objective and who did not interrupt TCZ. Percentage of participants on TCZ dose at Month 6 was calculated as the [(participants with specified TCZ dose at 6 months) divided by (participants who did not interrupt TCZ at Month 6)] multiplied by 100.|Month 6|All enrolled participants evaluable for primary objective and who did not interrupt TCZ at Month 6.|||percentage of participants|||Number
2651071|NCT01664104|Primary|Percentage of Participants on TCZ Treatment at Month 6|Percentage of participants on TCZ treatment at Month 6 was calculated as: [(participants on TCZ treatment at Month 6) divided by (participants evaluable for primary objective)] multiplied by 100. Confidence interval was computed based on the Clopper-Pearson method.|Month 6|All enrolled participants evaluable for primary objective.|||percentage of participants||95% Confidence Interval|Number
2651072|NCT01664091|Secondary|Baker Classification 2-Year Score|An independent assessment of contracture was conducted by a plastic surgeon or radiation oncologist who had not treated the participant. Photographic analysis incorporated five views (frontal, right and left lateral, and right and left quarter views). Baker classification was used to score the extent of contracture: Class IA-absolutely natural, cannot tell breast was reconstructed; Class IB-soft, but the implant is detectable by physical examination or inspection because of mastectomy; Class II-mildly firm reconstructed breast with an implant that may be visible and detectable by physical examination; Class III-moderately firm reconstructed breast with readily detectable implant, but the result may still be acceptable; or Class IV-severe capsular contracture with an unacceptable aesthetic outcome and/or significant patient symptoms requiring surgical intervention.|2 Years|The analysis population is comprised of the evaluable subset of participants with complete 2 year follow-up data.|||Participants|||Count of Participants
2651073|NCT01664091|Secondary|Baker Classification Peak Score|An independent assessment of contracture was conducted by a plastic surgeon or radiation oncologist who had not treated the participant. Photographic analysis incorporated five views (frontal, right and left lateral, and right and left quarter views). Baker classification was used to score the extent of contracture: Class IA-absolutely natural, cannot tell breast was reconstructed; Class IB-soft, but the implant is detectable by physical examination or inspection because of mastectomy; Class II-mildly firm reconstructed breast with an implant that may be visible and detectable by physical examination; Class III-moderately firm reconstructed breast with readily detectable implant, but the result may still be acceptable; or Class IV-severe capsular contracture with an unacceptable aesthetic outcome and/or significant patient symptoms requiring surgical intervention.|Assessed up to 2 years post PMRT|The analysis population excludes 1 participant lost-to follow-up who left the country immediately following PMRT.|||Participants|||Count of Participants
2651074|NCT01664091|Secondary|Cosmetic Score|Cosmesis was measured by means of strict photographic analysis using five views (frontal, right and left lateral, and right and left quarter views) and independent assessment of the results by a plastic surgeon or radiation oncologist who has not treated the patient. Cosmetic score was defined in 4 categories: Excellent = treated breast looks essentially the same as the opposite breast; Good = minimal but identifiable result of treatment; Fair = significant effects of radiation therapy noted; Poor = severe normal tissue sequelae.|2 years|The analysis population is comprised of the evaluable subset of participants with complete 2 year follow-up data.|||Participants|||Count of Participants
2651075|NCT01664091|Secondary|Lung Dose-Volume|Lung dose-volumes were assessed as a percentage of the ipsilateral lung irradiated via dose-volume histograms.|Lung dose-volume was measured at the end of radiation therapy which was up to 11 weeks from enrollment in this study cohort.|The analysis population is comprised of all enrolled participants.|||percentage radiation dose to lung||Full Range|Median
2651076|NCT01664091|Primary|Success Rate|Success rate was defined as the percentage of participants experiencing all of the following: 1) completion of PMRT and placement of the permanent implant and/or flap reconstruction; 2) no major complications (infection requiring hospitalization, major revisions, early/severe capsular contracture, or pain requiring implant removal); and 3) a physician-reported 'excellent' or 'good' cosmetic result (not 'fair' or 'poor') at 2 years following PMRT (requiring a stable reconstruction with good symmetry and contour relative to the contralateral breast).|2 years|The analysis population is comprised of the evaluable subset of participants with complete 2 year follow-up data.|||percentage of participants||95% Confidence Interval|Number
2651077|NCT01664052|Primary|Number of Occluded Fallopian Tubes 90 Days Following Placement as Measured by an HSG Evaluation|Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.|90 days after insert placement||||Occluded fallopian tubes|Participants||Number
2651078|NCT01664052|Primary|Number of Occluded Fallopian Tubes 60 Days Following Placement as Measured by an HSG Evaluation|Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.|60 days after insert placement||||Occluded fallopian tubes|Participants||Number
2651079|NCT01664052|Primary|Number of Occluded Fallopian Tubes 30 Days Following Placement as Measured by an HSG Evaluation|Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion. ESS505 and ESS505-A inserts are designed with the addition of an articulated hydrogel plug bonded to the distal portion of the insert with surgical grade adhesive and a nitinol support wire that remains inside the distal inner coil.|30 days after insert placement||||Occluded fallopian tubes|Participants||Number
2651080|NCT01664052|Primary|Number of Occluded Fallopian Tubes 60 Minutes After Placement of the Insert as Measured by an HSG Evaluation|Hysterosalpingogram (HSG) is an x-ray of the uterus and fallopian tubes after the injection of a contrast material (dye). This test evaluates tubal occlusion.|60 minutes after insert placement||||Occluded fallopian tubes|Participants||Number
2651081|NCT01664039|Secondary|Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6|TBUT (the time required for dry spots to appear on the corneal surface after blinking) was assessed by the investigator using slit lamp examination . A longer break up time is a sign of a more stable tear film. A positive number change from baseline indicates improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Month 3, Month 6|"This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||seconds||Standard Deviation|Mean
2651082|NCT01664039|Secondary|Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6|"The OSDI questionnaire (used to measure vision-related function, ocular symptoms, visual function, and environmental factors that may affect vision) was answered by the subject. Each of the 12 items was scored on a 0-4 Likert scale, where 0 is None of the time and 4 is All of the time. A resultant overall 0-100 score was calculated, with higher scores representing greater disability. A negative number change represents a perceived improvement in ocular health."|Baseline (Day 0), Month 3, Month 6|"This analysis population includes all randomized subjects who completed the questionnaire at baseline, received at least 1 dose of either study treatment, and had at least 1 post-baseline on-therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
2651083|NCT01664039|Secondary|Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6|Conjunctiva staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Conjunctiva staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Month 3, Month 6|This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.|||participants|||Number
2651084|NCT01664039|Secondary|Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6|Corneal staining was assessed after ophthalmic dye was instilled in the eye. The upper eyelid was lifted slightly, and the eye was compared to grading panels. Corneal staining was graded on a scale from 0 (absent) to 5 (severe). One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Month 3, Month 6|This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.|||participants|||Number
2658571|NCT01597388|Primary|Adverse Events Leading to Dose Reduction of AZD2014||Up to 28 Days|The analysis population consisted of all participants who received at least one dose of AZD2014.|||Participants|||Number
2651085|NCT01664039|Secondary|Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit|Ocular Hyperaemia (excess of blood in the white of the eyes (sclera)) was graded by the investigator on a 4-point scale where 0=None/Trace, 1=Mild, 2=Moderate, and 3=Severe. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Week 6, Month 3, Month 6|This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit with non-missing values by grade at the specific time point.|||participants|||Number
2651086|NCT01664039|Secondary|Percentage of Subjects Who Reached Target IOP at Each Visit|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. Target IOP was defined as ≤ 18 mmHg. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Week 6, Month 3, Month 6|"This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||percentage of participants|||Number
2651087|NCT01664039|Secondary|Mean Change From Baseline in IOP at Week 6 and Month 3|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in mmHg. A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Week 6, Month 3|"This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||mmHg||Standard Deviation|Mean
2651088|NCT01664039|Primary|Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6|IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the analysis.|Baseline (Day 0), Month 6|"This analysis population includes all randomized subjects who received at least 1 dose of either study treatment and had at least 1 post-baseline on therapy study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively."|||mmHg||Standard Deviation|Mean
2651089|NCT01663987|Secondary|Time to Event: Time to Recovery (EXACT-PRO) From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Time to event: Time to recovery based on EXACT-PRO total score. The percentage of observed patients recovered by end of study was reported.~Time to recovery was assessed with the EXACT-PRO questionnaire. EXACT-PRO total scores were transformed to smooth scores for determining time to recovery and all other endpoints related to the EXACT questionnaire. The day-2 score was transformed to the mean of the total scores recorded on Day 1, 2, and 3. Similarly, each subsequent day's score was transformed to the mean score using a rolling 3-day average.~Analysis based on Kaplan Meier estimate."|From first drug administration to the last timepoint with information of EXACT-PRO, up to 2 years|This endpoint was not analysed due to the trials being terminated prematurely due to low patient enrollment and the limited amount of data.|||Percentage of patients recovered|||Number
2651090|NCT01663987|Secondary|Number of All-cause Hospitalization Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Number of all-cause hospitalization per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.~This endpoint was analysed using combined data, as specified in the analysis plan."|From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 47 for Placebo and 38 for Tiotropium.|||Hospitalisation per patient year|||Number
2651091|NCT01663987|Secondary|Number of COPD Exacerbation Events From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Number of COPD exacerbation per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.~This endpoint was analysed using combined data, as specified in the analysis plan."|Start of treatment to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 73 for Placebo and 54 for Tiotropium.|||exacerbations per patient year|||Number
2651092|NCT01663987|Secondary|Percentage of Patients With 30-day Readmission Rates Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Percentage of patients with 30-day hospital readmission rates outcome events was analysed.~Days to hospital readmission were calculated as:Hospital readmission days = Readmission date - Date of hospital discharge + 1.~The 30-day hospital readmission analysis summarized the frequency of patients with hospital readmission and readmission days >1 and <31 days using the TS.~This endpoint was analysed using combined data, as specified in the analysis plan."|from date of hospital discharge prior to randomization up to readmission days >1 and <31 days|Treated set of the pooled twin studies 205.478 and 205.477|||Percentage of participants|||Number
2651093|NCT01663987|Secondary|Percentage of Patients With All-cause Hospitalization From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Percentage of patients with all-cause hospitalization outcome event occured during the study was analysed for the combined study.~All-cause hospitalization included all hospitalizations, except planned hospitalizations for elective procedures. Hospitalizations occurring on the same day as discharge were not considered a separate admission.~This endpoint was analysed using combined data, as specified in the analysis plan."|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated set of the pooled twin studies 205.478 and 205.477|||Percentage of participants|||Number
2651161|NCT01663714|Secondary|Nadir Values for Hemoglobin|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population|||Grams/deciliter (g/dL)||Full Range|Median
2651094|NCT01663987|Secondary|Percentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Percentage of patients with COPD exacerbation on study was analysed for the combined study.~A COPD exacerbation was defined as a complex of lower respiratory events/symptoms (increase or new onset) related to the underlying COPD with duration of three days or more, requiring a change in treatment where a complex of lower respiratory events/symptoms was defined as at least two of the following: 1) Shortness of breath; 2) Sputum production (volume); 3)Occurrence of purulent sputum; 4) Cough; 5) Wheezing; 6) Chest tightness. Onset of exacerbation was defined by the onset of first recorded symptom.The end of exacerbation was decided by the investigator based on clinical judgment.~A required change in treatment included either prescription of antibiotics and/or systemic steroids; and a newly prescribed maintenance respiratory medication (i.e. bronchodilators including theophyllines and PDE4-inhibitors).~This endpoint was analysed using combined data, as specified in the analysis plan."|from first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated set of the pooled twin studies 205.478 and 205.477|||Percentage of participants|||Number
2651095|NCT01663987|Secondary|Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.~This endpoint was analysed using combined data, as specified in the analysis plan."|Baseline and 12 weeks|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed at week 12 from the treated set were 59 for Placebo and 60 for Tiotropium.|||Litres||Standard Deviation|Mean
2651096|NCT01663987|Secondary|Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Change from baseline of Trough FEV1 (forced expiratory volume in one second) at 12 weeks on study drug.~Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug.~This endpoint was analysed using combined data, as specified in the analysis plan."|Baseline and 12 weeks|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed at week 12 from the treated set were 59 for Placebo and 60 for Tiotropium.|||Litres||Standard Deviation|Mean
2651097|NCT01663987|Secondary|Percentage of Patients With Adverse Clinical Event on Study|Percentage of patients with adverse clinical event during on study, which is defined as the combined endpoint of chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalisation, or all cause mortality.|From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated set|||Percentage of participants|||Number
2651098|NCT01663987|Secondary|Change From Baseline of Trough FVC at 12 Weeks on Study Drug|Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.|Baseline and 12 weeks|Treated Set (TS) including patients who had trough FVC data at both baseline and week 12|||Litres||Standard Deviation|Mean
2651099|NCT01663987|Primary|Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.477 (NCT01663987) and 205.478 (NCT01662986)|"Percentage of patients with next adverse clinical outcome event occured during the study, defined as the combined endpoint of chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality.~Time to the next adverse clinical outcome event from the two twin trials, was defined as a primary endpoint but was not analysed numerically, so this endpoint is presented instead.~This endpoint was analysed using combined data, as specified in the analysis plan."|From first drug administration to the last timepoint with information of clinical adverse outcome available, up to 2 years|Treated set of the pooled twin studies 205.478 and 205.477: This set includes all patients who were randomised and took at least one dose of study drug, 157 patients (79 Tiotropium and 78 placebo) were included in this set.|||Percentage of perticipants|||Number
2651100|NCT01663987|Primary|Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug|Change from baseline in trough forced expiratory volume in 1 second (FEV1) at 12 weeks on study medication. Trough FEV1 is defined as FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of drug.|Baseline and 12 weeks|Treated Set (TS) including patients who had trough FEV1 data at both baseline and week 12|||Litres||Standard Deviation|Mean
2651101|NCT01663935|Other Pre-specified|Contrast Sensitivity|Ancillary testing of visual/retinal function with contrast sensitivity testing. Contrast sensitivity testing measures how well the eyes can distinguish between finer and finer light increments compared to dark. This test is a chart with different capital letters organized in horizontal lines. The contrast decreases with each line. The person will move down the chart to determine the least level of contrast they can see.|3 months|participants pre and post medication per protocol for contrast sensitivity. Range could be anywhere from a score of 0 to 75 for each eye. The higher the score the more letters they could see in low contrast.|||score on a scale|eyes|Standard Deviation|Mean
2651102|NCT01663935|Primary|Visual Acuity Change|Change in visual acuity from baseline to 3 months as measured in logMAR by Snellen or Sweep visual evoked potential (SVEP). logMar lower values equals better visual outcome.|3 months|participants pre and post treatment per protocol|||logMar||Standard Deviation|Mean
2651103|NCT01663922|Primary|Pharmacokinetic of Boceprevir in the Presence of Ucalm (St John's Wort)|"Pharmacokinetic parameters (maximum and trough concentrations, and area under concentratof boceprevir and SJW will be evaluated when given in combination at steady-state to evaluate possible differences in concentrations during co-administration versus drug given alone.~The pharmacokinetic parameters calculated for boceprevir and SJW will be Ctrough,the maximum observed plasma concentration (Cmax), time point at Cmax (Tmax), and total drug exposure, expressed as the area under the plasma concentration-time curve.~All pharmacokinetic parameters will be calculated using non-compartmental modelling techniques (WinNonlin®) and all statistical calculations performed within-participant changes in the assessed pharmacokinetic parameters (drug alone vs drug combination) will be evaluated by calculating geometric mean ratios."|6 months|All participants who completed the three PK assessments were included in the analysis. BCP metabolites (SCH534128 & SCH523129) PK parameters were determined in the presence and absence of SJW, and hypericin PK parameters in the presence and absence of BCP; for the total study population.|||ng*h/mL||90% Confidence Interval|Geometric Mean
2658572|NCT01597388|Primary|Adverse Events||Up to 12 Months|The analysis population consisted of all participants who received at least one dose of AZD2014.|||Participants|||Number
2651104|NCT01663857|Secondary|Phase 2: Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) Total Score|"The Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) instrument measures health related quality of life (HRQoL) in participants with ovarian cancer. The instrument is organized into sections of physical, social/family, emotional, functional well-being and ovarian subscales with a 5-point rating scale in which 0 = not at all and 4 = very much. Data presented here are change from baseline at follow-up in the FACT-O Total Score. The total score is the sum of Physical Well Being (PWB) + Social Well-being (SWB) + Emotional Well Being (EWB) + Family Well-being (FWB) + Ovarian Cancer Subscale (OCS). The FACT-O Total score range 0 - 152 with higher scores indicating better quality of life."|Baseline, Study Completion (up to 3 years)|All participants in Phase 2 who received at least one dose of study drug and had at least one post baseline assessment.|||units on a scale||Standard Deviation|Mean
2651105|NCT01663857|Secondary|Phase 1b and 2: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 8 Hours (AUC 0-8) of LY2228820|PK parameters after administration of LY2228820 for both Phase 1b and Phase 2.|Phase1b:Cycle(C)1 Day(D)1:Predose(PRD),0.5,1,2,4,6,8 hours(hr)postdose(PD); C1D10:PRD,0.5,1,2,8hrPD; C2D10:PRD,0.5,1,2,4,6,8,12hrPD; C7D3:PRD,0.5,1,2,4,6hrPD; Phase 2: C1D3:PRD,0.5,1,2,4,6,8hrPD; C1D10:PRD,0.5,1,2,4,6,8hrPD; C7D3:PRD,0.5,1,2,4,6,8hrPD|All participants in Phase 1b and Phase 2 who received at least one dose of study drug and had evaluable PK data.|||nanograms * hr per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2651106|NCT01663857|Secondary|Phase 2: Overall Survival|Data presented are the median overall survival in months for participants in the Phase 2 treatment arms.|Baseline to Date of Death from any cause (up to 5 years)|All participants in Phase 2 who received at least one dose of drug.|||months||90% Confidence Interval|Median
2651107|NCT01663857|Secondary|Phase 2: Percentage of Participants Who Achieve Complete Response or Partial Response (Overall Response Rate)|Overall Response Rate was estimated as the percentage of participants with best response of Complete Response (CR) or Partial Response (PR), based on RECIST version 1.1 divided by the total number of randomized participants. CR is defined as disappearance of all target lesions. PR is defined as at least 30% disease in the sum of the largest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Baseline to Disease Progression (up to 3 years)|All participants who received at least one dose of study drug in Phase 2.|||percentage of participants|||Number
2651108|NCT01663857|Primary|Phase 2: Progression-free Survival (PFS) in Participants Treated With LY2228820 Plus Gemcitabine and Carboplatin Versus Placebo Plus Gemcitabine and Carboplatin|PFS was defined as time from date of randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred first. Progressive disease (PD) is defined as at least a 20% increase in the sum of the largest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Randomization to Date of Disease Progression or Death from any cause (up to 3 years)|All participants in Phase 2 who received at least one dose of study drug.|||months||90% Confidence Interval|Median
2651109|NCT01663857|Primary|Phase 1b: Recommended Phase 2 Dose of LY2228820 in Combination With Gemcitabine and Carboplatin (Maximum Tolerated Dose [MTD])|Recommended Phase 2 dose of LY2228820 that could be safely administered in combination with gemcitabine and carboplatin based on defined dose limiting toxicities (DLT) assessment and MTD definition. The MTD is defined as the highest dose level at which no more than 33% of patients experience a DLT during Cycle 1 that does not exceed the single-agent MTD for LY2228820 (300 mg Q12H).|Cycle 1 (21 Days)|All participants who received at least one dose of study drug in Phase 1b.|||milligrams (mg)|||Number
2651110|NCT01663779|Primary|First Pass Success When Attempting Arterial Catheterization.|first pass success when attempting arterial catheterization of the artery|Immediate, upon study entry||||participants|||Number
2651111|NCT01663740|Secondary|Percentage of Participants With Improved Sperm Density From EOT to End of FU|Participants who had higher sperm density compared with the previous visit were considered as improved.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percentage of participants|||Number
2651112|NCT01663740|Secondary|Percentage of Participants With Improved Sperm Density From Baseline to EOT and End of FU|Participants who had higher sperm density compared with the previous visit were considered as improved.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||percentage of participants|||Number
2651113|NCT01663740|Secondary|Percentage of Participants With Improved TUNEL Score From EOT to End of FU|Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Participants who had a lower TUNEL score compared to the previous time point were considered as improved.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percentage of participants|||Number
2651114|NCT01663740|Secondary|Percentage of Participants With Improved TUNEL Score From Baseline to EOT and End of FU|Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Participants who had a lower TUNEL score compared to the previous time point were considered as improved.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||percentage of participants|||Number
2651115|NCT01663740|Secondary|Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From EOT to End of FU|Abnormal sperm density was considered as sperm density <20 mil/mL. Change in abnormal to abnormal sperm density and normal to abnormal sperm density from EOT to end of FU was reported.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percentage of participants|||Number
2651162|NCT01663714|Secondary|Nadir Values for Absolute Neutrophil Count (ANC)|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population|||10^3 cells/cubic millimeters (mm^3)||Full Range|Median
2651116|NCT01663740|Secondary|Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From Baseline to EOT and End of FU|Abnormal sperm density was considered as sperm density less than (<) 20 mil/mL. Change in abnormal to abnormal sperm density and normal to abnormal sperm density from baseline to EOT and end of FU was reported.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||percentage of participants|||Number
2651117|NCT01663740|Secondary|Change in Inhibin B Level From EOT to End of FU|Inhibin B level was calculated based on the average of two samples. Change was calculated as the inhibin B level measured at FU - the inhibin B level measured at EOT for each participant. A negative change from EOT indicated a lower inhibin B level.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||pg/mL||Standard Error|Mean
2651118|NCT01663740|Secondary|Change in Inhibin B Level From Baseline to EOT and End of FU|Inhibin B level was calculated based on the average of two samples. Change was calculated as the inhibin B level measured at post-baseline visit (EOT and FU) - the inhibin B level measured at baseline for each participant. A negative change from baseline indicated a lower inhibin B level.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||pg/mL||Standard Error|Mean
2651119|NCT01663740|Secondary|Change in Prolactin Level From EOT to End of FU|Prolactin level was calculated based on the average of two samples. Change was calculated as the prolactin level measured at FU - the prolactin level measured at EOT for each participant. A negative change from EOT indicated a lower prolactin level.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||mU/mL||Standard Error|Mean
2651120|NCT01663740|Secondary|Change in Prolactin Level From Baseline to EOT and End of FU|Prolactin level was calculated based on the average of two samples. Change was calculated as the prolactin level measured at post-baseline visit (EOT and FU) - the prolactin level measured at baseline for each participant. A negative change from baseline indicated a lower prolactin level.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||mU/mL||Standard Error|Mean
2651121|NCT01663740|Secondary|Change in FSH Level From EOT to End of FU|FSH level was calculated based on the average of two samples. Change was calculated as the FSH level measured at FU - the FSH level measured at EOT for each participant. A negative change from EOT indicated a lower FSH level.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||U/L||Standard Error|Mean
2651122|NCT01663740|Secondary|Change in FSH Level From Baseline to EOT and End of FU|FSH level was calculated based on the average of two samples. Change was calculated as the FSH level measured at post-baseline visit (EOT and FU) - the FSH level measured at baseline for each participant. A negative change from baseline indicated a lower FSH level.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||U/L||Standard Error|Mean
2651123|NCT01663740|Secondary|Change in LH Level From EOT to End of FU|LH level was calculated based on the average of two samples. Change was calculated as the LH level measured at FU - the LH level measured at EOT for each participant. A negative change from EOT indicated a lower LH level.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||mU/mL||Standard Error|Mean
2651124|NCT01663740|Secondary|Change in LH Level From Baseline to EOT and End of FU|LH level was calculated based on the average of two samples. Change was calculated as the LH level measured at post-baseline visit (EOT and FU) - the LH level measured at baseline for each participant. A negative change from baseline indicated a lower LH level.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||mU/mL||Standard Error|Mean
2651125|NCT01663740|Secondary|Change in Total Testosterone Level From EOT to End of FU|Testosterone level was calculated based on the average of two samples. Change was calculated as the testosterone level measured at FU - the testosterone level measured at EOT for each participant. A negative change from EOT indicated a lower testosterone level.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||nmol/L||Standard Error|Mean
2651126|NCT01663740|Secondary|Change in Total Testosterone Level From Baseline to EOT and End of FU|Testosterone level was calculated based on the average of two samples. Change was calculated as the testosterone level measured at post-baseline visit (EOT and FU) - the testosterone level measured at baseline for each participant. A negative change from baseline indicated a lower testosterone level.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||nmol/L||Standard Error|Mean
2651127|NCT01663740|Secondary|Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From EOT to End of FU|Sperm morphology was evaluated based on the average of two semen samples. Change was calculated as the sperm morphology measured at FU - the sperm morphology measured at EOT for each participant. A positive change from EOT indicated an improved sperm morphology.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percentage of normal sperm cells||Standard Error|Mean
2651171|NCT01663714|Secondary|Number of Participants With Unconfirmed Complete Response (CR), as Assessed by the Investigator|CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population|||participants|||Number
2651128|NCT01663740|Secondary|Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From Baseline to EOT and End of FU|Sperm morphology was evaluated based on the average of two semen samples. Change was calculated as the sperm morphology measured at post-baseline visit (EOT and FU) - the sperm morphology measured at baseline for each participant. A positive change from baseline indicated an improved sperm morphology.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||percentage of normal sperm cells||Standard Error|Mean
2651129|NCT01663740|Secondary|Change in Total Motility of Sperm From EOT to End of FU|Sperm motility was calculated based on the average of two semen samples. Percent was determined by the calculation of motile sperm/total sperm count. Change was calculated as the sperm motility measured at FU - the sperm motility measured at EOT for each participant. A negative change from EOT indicated a lower sperm motility (worsening).|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percent motility||Standard Error|Mean
2651130|NCT01663740|Secondary|Change in Total Motility of Sperm From Baseline to EOT and End of FU|Sperm motility was calculated based on the average of two semen samples. Percent was determined by the calculation of motile sperm/total sperm count. Change was calculated as the sperm motility measured at post-baseline visit (EOT and FU) - the sperm motility measured at baseline for each participant. A negative change from baseline indicated a lower sperm motility (worsening).|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||percent motility||Standard Error|Mean
2651131|NCT01663740|Secondary|Change in Sperm Density From Baseline to End of FU|Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at post-baseline visit (FU) - the sperm density measured at baseline for each participant. A negative change from baseline indicated a lower sperm density (worsening).|Baseline, end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||mil/mL||Standard Error|Mean
2651132|NCT01663740|Secondary|Change in Sperm Density From EOT to End of FU|Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at FU - the sperm density measured at EOT for each participant. A negative change from EOT indicated a lower sperm density (worsening).|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||mil/mL||Standard Error|Mean
2651133|NCT01663740|Secondary|Change in Seminal Volume From EOT to End FU|Seminal volume was calculated based on the average of two semen samples. Change was calculated as the seminal volume measured at FU - the seminal volume measured at EOT for each participant. A negative change from EOT indicated a lower seminal volume (worsening).|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||mL||Standard Error|Mean
2651134|NCT01663740|Secondary|Change in Seminal Volume From Baseline to EOT and End of FU|Seminal volume was calculated based on the average of two semen samples. Change was calculated as the seminal volume measured at post-baseline visit (EOT and FU) - the seminal volume measured at baseline for each participant. A negative change from baseline indicated a lower seminal volume (worsening).|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||mL||Standard Error|Mean
2651135|NCT01663740|Secondary|Change in TUNEL Score From EOT to End of FU|Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Change was calculated as the TUNEL score measured at FU minus the TUNEL score measured at EOT for each participant. A negative change from EOT indicated a lower TUNEL score. TUNEL score represents percentage of sperm with fragmented DNA; total score ranged from 0% to 100%, higher score represents more fragmentation.|EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||percent score||Standard Error|Mean
2651136|NCT01663740|Secondary|Change in Terminal Uridine Nick-End Labeling (TUNEL) Score From Baseline to EOT and End of Follow-up (FU)|Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Change was calculated as the TUNEL score measured at post-baseline visit (EOT and FU) minus the TUNEL score measured at baseline for each participant. A negative change from baseline indicated a lower TUNEL score. TUNEL score represents percentage of sperm with fragmented DNA; total score ranged from 0 percent (%) to 100%, higher score represents more fragmentation.|Baseline, EOT (Week 28), end of FU (Week 52)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.|||percent score||Standard Error|Mean
2651137|NCT01663740|Primary|Change in Sperm Density From Baseline to the End of Treatment (EOT)|Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at post-baseline visit (EOT) minus (-) the sperm density measured at baseline for each participant. A negative change from baseline indicated a lower sperm density (worsening).|Baseline, EOT (Week 28)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.|||mil/mL||Standard Error|Mean
2651138|NCT01663727|Secondary|Secondary: Percentage of Participants Who Were Alive at 1 Year - High Baseline Plasma VEGF-A ITT Population||1 year|High Baseline Plasma VEGF-A ITT Population|||percentage of participants|||Number
2651139|NCT01663727|Secondary|Percentage of Participants Who Were Alive at 1 Year - ITT Population||1 year|ITT Population.|||percentage of participants|||Number
2651190|NCT01663506|Secondary|Clinical Disease Activity Index (CDAI) Score|The CDAI is the numerical sum of 4 outcome parameters: TJC28, SJC28, PtGA, and PGA. Description of these outcome parameters is given come measure 9, 10, and 18. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||units on a scale||Standard Deviation|Mean
2651140|NCT01663727|Secondary|Duration of Response - High Baseline Plasma VEGF-A ITT Population|Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.|Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 111.3 weeks)|Number of participants analyzed=participants from high baseline plasma VEGF-A ITT population who had an objective response.|||months||95% Confidence Interval|Median
2651141|NCT01663727|Secondary|Duration of Response - ITT Population|Duration of response was defined as the time from the initial date of the objective response to documented disease progression or death (whichever occurred first). Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. Analysis was performed using Kaplan Meier method.|Baseline, every 8 weeks until documented disease progression or clinical cut-off (up to 117.7 weeks)|Number of participants analyzed=participants from ITT population who had an objective response.|||months||95% Confidence Interval|Median
2651142|NCT01663727|Secondary|Percentage of Participants With an Objective Response - High Baseline Plasma VEGF-A ITT Population|Objective response was defined as having a CR or PR according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, CT, or MRI.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)|Number of participants analyzed=participants from high baseline plasma VEGF-A ITT population with measurable disease at baseline.|||percentage of participants||95% Confidence Interval|Number
2651143|NCT01663727|Primary|PFS in High Baseline Plasma VEGF-A ITT Population|PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)|High baseline plasma VEGF-A ITT population.|||months||95% Confidence Interval|Median
2651144|NCT01663727|Primary|Percentage of Participants With Progression or Death in High Baseline Plasma Vascular Endothelial Growth Factor-A (VEGF-A) ITT Population|Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 111.3 weeks)|High baseline plasma VEGF-A ITT population: All participants randomized to study treatment with high baseline plasma VEGF-A levels (VEGF-A levels greater than or equal to 5.05 picograms per milliliter), irrespective of whether the assigned treatment was actually received.|||percentage of participants|||Number
2651145|NCT01663727|Secondary|Percentage of Participants With an Objective Response - ITT Population|Objective response was defined as having a Complete Response (CR) or Partial Response (PR) according to a RECIST criteria v 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to <10 mm in short axis and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. Measurable disease was defined by the presence of at least one measurable lesion by clinical measurement, chest x-ray, computed tomography (CT), or magnetic resonance imaging (MRI).|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)|Number of participants analyzed=participants from ITT population with measurable disease at baseline.|||percentage of participants||95% Confidence Interval|Number
2651146|NCT01663727|Secondary|OS - High Baseline Plasma VEGF-A ITT Population|OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.|From randomization till death or clinical cut-off (up to 244 weeks)|High Baseline Plasma VEGF-A ITT population.|||months||95% Confidence Interval|Median
2651147|NCT01663727|Secondary|Percentage of Participants Who Died - High Baseline Plasma VEGF-A ITT Population||From randomization till death or clinical cut-off (up to 244 weeks)|High Baseline Plasma VEGF-A ITT Population.|||percentage of participants|||Number
2651148|NCT01663727|Secondary|Overall Survival (OS) - ITT Population|OS was defined as the interval between the date of randomization and death from any cause. OS was estimated using Kaplan Meier method.|From randomization till death or clinical cut-off (up to 244 weeks)|ITT population.|||months||95% Confidence Interval|Median
2651149|NCT01663727|Secondary|Percentage of Participants Who Died - ITT Population||From randomization till death or clinical cut-off (up to 244 weeks)|ITT Population.|||percentage of participants|||Number
2651150|NCT01663727|Primary|Progression Free Survival (PFS) in ITT Population|PFS was defined as the interval between the date of randomization and the first documentation of progressive disease or death from any cause. Tumor assessment was performed as per RECIST v1.1 by investigator. Disease progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or presence of new lesions. PFS was estimated using Kaplan Meier method.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)|ITT population.|||months||95% Confidence Interval|Median
2651151|NCT01663727|Primary|Percentage of Participants With Progression or Death in Intent-to-Treat (ITT) Population|Tumor assessment was performed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator. Disease progression was defined as at least 20 percent (%) increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm), unequivocal progression of existing non-target lesions, or presence of new lesions.|Baseline, every 8 weeks until documented disease progression, death or clinical cut-off (up to 117.7 weeks)|ITT population.|||percentage of participants|||Number
2651152|NCT01663714|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population|||months||95% Confidence Interval|Median
2651153|NCT01663714|Secondary|Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Study Entry) But Positive or Negative at Month 24|"The administration of murine antibodies may form HAMA. A HAMA assay was performed using the ImmunoSTRIP HAMA IgG enzyme-linked immune absorbent assay by a central laboratory (Covance Classic Laboratory Services, Indianapolis, IN). To be positive, a participant had to have a positive HAMA assessment during the first 24 months."|Day 1 to Day 730 (24 months) after receiving the dosimetric dose|ITT Exposed Population|||participants|||Number
2651154|NCT01663714|Secondary|Number of Participants Who Received Any Supportive Care|Supportive care is defined as interventions that help the participants achieve comfort but do not affect the course of a disease.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT-Exposed Population|||participants|||Number
2651155|NCT01663714|Secondary|Number of Participants With the Indicated Primary Cause of Death|The primary cause of death of the participants was assessed by the Investigator.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. All participants who died during the study were analyzed.|||participants|||Number
2651156|NCT01663714|Secondary|Number of Participants With Any Treatment-related Serious Adverse Event (SAE)|An SAE is defined as any event occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience (at immediate risk of death from the experience as it occurred), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious adverse drug experience when based upon appropriate medical judgment.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT-Exposed Population. All participants who experienced a treatment-related SAE were analyzed.|||participants|||Number
2651157|NCT01663714|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. The Investigator assessed whether the AE was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities (values outside the normal range) were assumed to be possibly or probably related to study drug.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population|||participants|||Number
2651158|NCT01663714|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs)|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population|||participants|||Number
2651159|NCT01663714|Secondary|Nadir Values for WBC Count|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population|||10^3 cells/µL||Full Range|Median
2651160|NCT01663714|Secondary|Nadir Values for Platelet Count|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population|||10^3 cells/microliter (µL)||Full Range|Median
2654703|NCT01633853|Secondary|The Incidence Rate of Secondary Hyperparathyroidism.|Patients with the blood iPTH level higher than 300 pg/ml will be regard as sHPT. The incidence of sHPT during following up were recorded and compared between two groups.|24 months||||participants|||Number
2651163|NCT01663714|Secondary|Time to Recovery (TTR) to Baseline (BL) for Hematologic Laboratory (Lab.) Evaluations|TTR to BL grade (gr.) for par. with a Gr. 0 toxicity (tox.=lab. value outside the normal range) at BL=time from the last administration of study drug (SD) to the first post-nadir (PN) date with Gr. 0 toxicity with no other Gr. 1-4 toxicities recorded within the next week. For par. with a higher gr. tox. at BL, TTR=time from the last administration of SD to the first PN date with the BL gr. or better with no other higher gr. toxicities recorded during the next week. Each lab. established its own reference range using data from its own equipment/methods; there is no standard reference range.|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population. Only those participants with hematologic toxicity were evaluated for time to recovery to baseline.|||days||95% Confidence Interval|Median
2651164|NCT01663714|Secondary|Time to Nadir for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, Platelets, and White Blood Cell (WBC) Count|Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).|Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)|ITT Exposed Population|||days||Full Range|Median
2651165|NCT01663714|Secondary|Total Body Residence Time (TBRT; Average Amount of Time TST Spends in the Body, Calculated From the Rate of TB Clearance of Radioactivity During the Dosimetric Dose [DD]) of Iodine 131 TST Antibody Following the DD|To determine TBRT, the percent-injected activity (PIA) is calculated from the background-corrected (BC) total body count (TBC) at D 0; D 2/3/4; and D 7. The time from the DD to the acquisition of whole body count (WBC) is then determined. The PIA remaining at each time point (TP) is then calculated by dividing the BC WBC for that TP by the BC WBC from the first TP (D 0) * 100. To determine RT, a best-fit line from 100% (pre-plotted D 0 value) through 2 plotted points (other TPs) is made. TBRT=the x-axis value at the point where the line intersects the horizontal 37% injected activity line.|Day (D) 0; D 2, 3, or 4; and D 6 or 7|ITT Exposed Population|||hours||Standard Deviation|Mean
2651166|NCT01663714|Secondary|Time to Treatment Failure, as Assessed by the Investigator|Time to treatment failure is defined as the time from the start of treatment to the first occurrence of study withdrawal, progression, or death.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. If a participant did not have treatment failure, that participant was censored in the survival analysis.|||months||95% Confidence Interval|Median
2651167|NCT01663714|Secondary|Time to Progression of Disease or Death, as Assessed by the Investigator|Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. Disease progression is defined as a >=50% increase from the nadir value (lowest laboratory value recorded following administration of the study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >1.5 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. If a participant did not have progression or did not die, that participant was censored in the survival analysis.|||months||95% Confidence Interval|Median
2651168|NCT01663714|Secondary|DOR for Unconfirmed and Confirmed Complete Response, as Assessed by the Investigator|DOR=the time from the first documented response (for par. with CR) until disease progression (DP). DP=a >=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >1.5 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. Only those participants with response were analyzed. Participants who did not experience progression were censored.|||months||95% Confidence Interval|Median
2651169|NCT01663714|Secondary|Duration of Response (DOR), as Assessed by the Investigator|DOR=the time from the first documented response (for par. with CR, CRu, or PR) until disease progression (DP). DP=a >=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >1.5 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population. Only those participants with response were analyzed. Participants who did not experience progression were censored.|||months||95% Confidence Interval|Median
2651170|NCT01663714|Secondary|Number of Participants With Confirmed Complete Response (CR), as Assessed by the Investigator|CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy. Confirmed response required CR, which was confirmed by 2 separate response evaluations >=4 weeks apart.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|ITT Exposed Population|||participants|||Number
2651292|NCT01662960|Primary|Rivermead Assessment of Somatosensory Performance|This test measures the integrity of sensory perception of the arm. The score is the proportion of items answered correctly, and ranges from 0 to 1 with higher scores indicating better performance.|1 month|All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.|||Proportion of items correct.||Standard Deviation|Mean
2651172|NCT01663714|Primary|Number of Participants (Par.) With Confirmed Response (Complete Response [CR], Complete Response/Unconfirmed [CRu], or Partial Response [PR]), as Assessed by the Investigator|CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. CRu: complete resolution of all disease-related symptoms; residual lymph node mass >1.5 centimeters in the greatest transverse diameter that has regressed by >75%, indeterminate bone marrow, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. Confirmed response required CR, CRu, or PR, which were confirmed by 2 separate response evaluations >=4 weeks apart.|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for response were analyzed.|||participants|||Number
2651173|NCT01663714|Primary|Number of Participants (Par.) With Unconfirmed Response (Complete Response, Complete Response/Unconfirmed, or Partial Response), as Assessed by the Investigator|Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Complete Response/unconfirmed (CRu: complete resolution of all disease-related symptoms; residual lymph node mass >1.5 centimeters in the greatest transverse diameter that has regressed by >75%, indeterminate bone marrow, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for response were analyzed.|||participants|||Number
2651174|NCT01663636|Primary|Completion of 3 Doses of Pentavalent Vaccine|Number of children vaccinated with the recommended dose of Pentavalent vaccines according to the age schedule of the National Immunization Program in Guatemala|8 months of age||||participants|||Number
2651175|NCT01663623|Secondary|Number of Participants With Major Relapse During the Double-blind Phase of the Study|Data for number of participants with major relapse [defined as experiencing at least 1 major Birmingham Vasculitis Activity Score (BVAS) item] during the double-bind phase of the study was reported. Analysis was performed using a Cox proportional hazard model.|Approximately up to 4 years|Intent-to-treat population|||Participants|||Number
2651176|NCT01663623|Primary|Time to First Relapse|Time to relapse is defined as the number of days from Day 0 until the participant experienced a relapse (relapse date - treatment start date +1). Only post-baseline relapses were considered in these analyses. Only relapses occurring up to and including the last visit date in the double-blind treatment period were considered in these analyses. Intent-to-treat population comprised of all randomized participants who received at least one dose of study agent (belimumab or placebo). NA indicates that the data was not available as the Number of events is too low to estimate the value. Median and Inter-quartile range were presented and were based on Kaplan Meier estimates.|Approximately up to 4 years|Intent-to-treat population|||Days||Inter-Quartile Range|Median
2651177|NCT01663532|Secondary|Responder Rate Based on PANSS Total Score.|Responder rate was defined as ≥30% reduction from Baseline in PANSS Total Score. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Week 10|Efficacy sample was defined as the ITT population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.|||participants|||Number
2651178|NCT01663532|Secondary|Mean Clinical Global Impression-Improvement Scale (CGI-I) Score at Endpoint.|"The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: Considering your total experience with this particular population, how mentally ill is the patient at this time? Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants."|Week 10|Efficacy sample was defined as the ITT population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.|||Units on a scale||Standard Deviation|Mean
2651179|NCT01663532|Secondary|Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Score.|The PSP was a validated clinician scale that measured personal and social functionining in 4 domains: socially useful activities eg, work and study), personal and social relationships, self-care, disturbing and aggressive behaviours. Impairement in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval and the study physician's judgement to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented varying degrees of disability (31 to 70) and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Week 10|Efficacy sample included participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had one Post-Baseline efficacy assessment. LOCF was used to impute the missing data with the recorded value obtained at the preceding visit.|||Units on a scale||Standard Error|Least Squares Mean
2651191|NCT01663506|Secondary|Simplified Disease Activity Index (SDAI) Score|The SDAI is the numerical sum of five outcome parameters: TJC28, SJC28, PtGA, PGA, and CRP. Description of these outcome parameters is given in outcome measure 9, 10, 16, and 18. SDAI total score = 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||units on a scale||Standard Deviation|Mean
2651180|NCT01663532|Secondary|Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated- absence of symptoms and a score of 7 indicated- extremely severe symptoms. The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs were: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. PANSS Negative Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 10|Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.|||Units on a scale||Standard Error|Least Squares Mean
2651181|NCT01663532|Secondary|Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS Positive Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 10|Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.|||Units on a scale||Standard Error|Least Squares Mean
2651182|NCT01663532|Secondary|Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.|"The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: Considering your total experience with this particular population, how mentally ill is the patient at this time? Response choices included were: 0= not assessed; 1= normal; not at all ill; 2= borderline mentally ill; 3= mildly ill; 4= moderately ill; 5= markedly ill; 6= severely ill; and 7= among the most extremely ill participants."|Baseline to Week 10|Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 168 participants from aripiprazole and placebo groups were available.|||Units on a scale||Standard Error|Least Squares Mean
2651183|NCT01663532|Primary|Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). The primary statistical comparison was performed using the Mixed Model Repeated Measure (MMRM) approach.|Baseline to Week 10|Efficacy sample was defined as the intent to treat (ITT) population which included randomized participants who took at least one injection of double-blind (aripiprazole IM depot or placebo) and had at least one Post-Baseline efficacy assessment. Data of only 162 and 167 participants from aripiprazole and placebo groups were available.|||Units on a scale||Standard Error|Least Squares Mean
2651184|NCT01663506|Secondary|Number of Participants With Disease Activity Status Based on CDAI Score|Participants were assigned the disease activity status on the basis of CDAI score. Description of CDAI score calculation is provided in Outcome Measure 20. Remission: CDAI score <= 2.8; low disease activity: CDAI <=10.0; moderate disease activity: CDAI <=22.0; and high disease activity: CDAI >22.0.|Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||participants|||Number
2651185|NCT01663506|Secondary|Number of Participants With Disease Activity Status Based on SDAI Score|Participants were assigned the disease activity status on the basis of SDAI score. Description of SDAI score calculation is provided in Outcome Measure 19. Remission: SDAI score <= 3.3; low disease activity: SDAI <=11.0; moderate disease activity: SDAI <=26.0; and high disease activity: SDAI >26.0.|Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||participants|||Number
2651186|NCT01663506|Secondary|Number of Participants With Disease Activity Status Based on DAS28 Score|Participants were assigned the disease activity status on the basis of DAS28 score. Description of DAS28 calculation is provided in Outcome Measure 7. Remission: DAS28 score <= 2.6; low disease activity: DAS28 <=3.2; moderate disease activity: DAS28 <=5.1; and high disease activity: DAS28 >5.1.|Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||participants|||Number
2651187|NCT01663506|Secondary|Number of Participants Receiving Oral Corticosteroids||Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||Participants|||Count of Participants
2651188|NCT01663506|Secondary|Number of Participants Who Received Tocilizumab in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs)||Baseline, Study end (at Month 12 or at time of study discontinuation)|FAS.|||participants|||Number
2651189|NCT01663506|Secondary|Number of Participants Who Received Tocilizumab as Monotherapy||Baseline, Study end (at Month 12 or at time of study discontinuation)|FAS.|||participants|||Number
2651218|NCT01663402|Secondary|Time to Cardiovascular Death; Percentage of Observed Participants With Outcome Measure Events During the Study|Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the CV death over time. Percentage of observed participants with CV death (positively adjudicated by CEC in a blinded fashion) were reported.|From randomization up to 64 months|ITT Population.|||percentage of participants|||Number
2651192|NCT01663506|Secondary|Number of Swollen and Tender Joints Based on 28 Joints|Number of swollen joints was determined by examination of 28 (SJC28) joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 28 joints (TJC28) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point for specified category.|||joints count||Standard Deviation|Mean
2651193|NCT01663506|Secondary|Number of Swollen and Tender Joints Based on 66 and 68 Joints|Number of swollen joints was determined by examination of 66 joints (SJC66) and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 68 joints (TJC68) and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, 0 = no tenderness, 1 = tenderness.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point for specified category.|||joints count||Standard Deviation|Mean
2651194|NCT01663506|Secondary|C-Reactive Protein (CRP)|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range is up to 10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||mg/L||Standard Deviation|Mean
2651195|NCT01663506|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||mm/hr||Standard Deviation|Mean
2651196|NCT01663506|Secondary|Visual Analog Scale-Morning Stiffness (VAS-MS)|Participants assessed their morning stiffness using a 0 - 100 mm VAS, where 0 mm = no stiffness and 100 mm = worst possible stiffness.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||mm||Standard Deviation|Mean
2651197|NCT01663506|Secondary|Visual Analog Fatigue Scale (VAFS)|Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||mm||Standard Deviation|Mean
2651198|NCT01663506|Secondary|Visual Analog Scale (VAS)-Pain|Intensity of pain was measured on a 100 mm line VAS marked by participant. It ranged (over the past week): 0 = no pain to 100 = worst possible pain.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||mm||Standard Deviation|Mean
2651199|NCT01663506|Secondary|Health Assessment Questionnaire-Disability Index (HAQ-DI) Score|HAQ-DI: participant reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on a 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible score range was 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||units on a scale||Standard Deviation|Mean
2651200|NCT01663506|Secondary|Patient Global Assessment (PtGA) of Disease Activity Score|PtGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||mm||Standard Deviation|Mean
2651201|NCT01663506|Secondary|Physician Global Assessment (PGA) of Disease Activity|PGA of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity.|Baseline, Month 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||mm||Standard Deviation|Mean
2651202|NCT01663506|Secondary|Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Description of DAS28 calculation is provided in Outcome Measure 7. Good responders: decrease from baseline >1.2 with DAS28 <= 3.2; moderate responders: decrease from baseline >1.2 with DAS28 >3.2 or decrease from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: decrease from baseline <= 0.6 or decrease from baseline >0.6 and <=1.2 with DAS28 >5.1.|Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.|||participants|||Number
2651219|NCT01663402|Secondary|Time to Coronary Heart Disease Death; Percentage of Observed Participants With Outcome Measure Events During the Study|Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the CHD death over time. Percentage of observed participants with CHD death (positively adjudicated by CEC in a blinded fashion) were reported.|From randomization up to 64 months|ITT Population.|||percentage of participants|||Number
2651203|NCT01663506|Secondary|Disease Activity Score Based on 28-joints Count (DAS28)|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment (PtGA) of disease activity. DAS28 total score range = 0 to 10, where higher scores indicates higher disease activity. DAS28 less than and equal to (<=) 2.6 meant clinical remission; DAS28 <=3.2 meant low disease activity; DAS28 greater than (>) 3.2 to 5.1 implied moderate disease activity; and DAS28 >5.1 implied high disease activity.|Baseline, Month 3, 6, and 12|FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||units on a scale||Standard Deviation|Mean
2651204|NCT01663506|Secondary|Number of Participants With Prior Exposure of Biologics||Baseline|FAS.|||participants|||Number
2651205|NCT01663506|Secondary|Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs)||Baseline|FAS.|||participants|||Number
2651206|NCT01663506|Secondary|Number of Participants With Comorbidities at Baseline|Participants were assessed for any comorbidity at study entry including anemia, fatigue, conventional risk factors for cardiovascular disease, C-reactive protein (CRP) level above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis, interstitial lung disease, and so on. Number of participants with each comorbidity was reported. One participant could have presented with more than 1 comorbidity.|Baseline|FAS.|||participants|||Number
2651207|NCT01663506|Secondary|Percentage of Participants With Tocilizumab Dose Modification, Interruption, and Irregularity|Dose modification was defined as an increase or decrease in the dose of study drug compared to the previous dose received. Interruption was defined as temporary or permanent discontinuation of study drug due to any reason, for example adverse event. Irregularity was defined as a time interval of greater than and equal to (>=) 75 days between two consecutive doses of study drug.|Up to Month 12|FAS.|||percentage of participants|||Number
2651208|NCT01663506|Secondary|Percentage of Participants With Tocilizumab Treatment at 12 Months After Treatment Initiation||Month 12|FAS.|||percentage of participants||95% Confidence Interval|Number
2651209|NCT01663506|Primary|Percentage of Participants With Tocilizumab Treatment at 6 Months After Treatment Initiation||6 Months|FAS.|||percentage of participants||95% Confidence Interval|Number
2651210|NCT01663402|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Months 4, 12, and 48: On-Treatment Analysis|Adjusted Least-squares (LS) means and standard errors at Month 4, 12 and 48 were obtained from a mixed-effect model with repeated measures (MMRM) including available post-baseline on-treatment data from Month 1 up to Month 48 (i.e. up to 21 days after last injection).|Baseline, Months 4, 12 and 48|Randomized and treated population. Here, 'number analyzed’ signifies participants evaluable for this outcome measure at specified time points.|||Percent change||Standard Error|Least Squares Mean
2651211|NCT01663402|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Months 4, 12, and 48: ITT Analysis|Adjusted means and standard errors at Month 4, 12 and 48 from multiple imputation approach (to account for missing data) followed by analyses of covariance (ANCOVA) model with the fixed categorical effect of treatment group and the continuous fixed covariate of baseline LDL-C value, including all available post-baseline data from Month 1 up to Month 48 regardless of status on- or off-treatment.|Baseline, Months 4, 12 and 48|ITT Population. Here, ‘number analyzed’ corresponds to the number of participants with the parameter measured and baseline measure available for each time-point. A multiple approach was used to account for participants with missing data.|||Percent change||Standard Error|Least Squares Mean
2651212|NCT01663402|Secondary|Time to First Occurrence of Any Congestive Heart Failure (CHF) Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study|Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any CHF requiring hospitalization over time. Percentage of observed participants with any CHF requiring hospitalization (positively adjudicated by CEC in a blinded fashion) were reported.|From randomization up to 64 months|ITT Population.|||percentage of participants|||Number
2651213|NCT01663402|Secondary|Time to First Occurrence of Any Ischemia-Driven Coronary Revascularization Procedure; Percentage of Observed Participants With Outcome Measure Events During the Study|Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any ischemia-driven coronary revascularization procedure over time. Percentage of observed participants with any ischemia-driven coronary revascularization procedure (positively adjudicated by CEC in a blinded fashion) were reported.|From randomization up to 64 months|ITT Population.|||percentage of participants|||Number
2651214|NCT01663402|Secondary|Time to First Occurrence of Any Unstable Angina Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study|Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any UA requiring hospitalization over time. Percentage of observed participants with any UA requiring hospitalization (positively adjudicated by CEC in a blinded fashion) were reported.|From randomization up to 64 months|ITT Population.|||percentage of participants|||Number
2651215|NCT01663402|Secondary|Time to First Occurrence of Fatal or Any Non-Fatal Ischemic Stroke; Percentage of Observed Participants With Outcome Measure Events During the Study|Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of fatal or any non-fatal IS over time. Percentage of observed participants with fatal or any non-fatal IS (positively adjudicated by CEC in a blinded fashion) were reported.|From randomization up to 64 months|ITT Population.|||percentage of participants|||Number
2651216|NCT01663402|Secondary|Time to First Occurrence of Any Non-Fatal Myocardial Infarction; Percentage of Observed Participants With Outcome Measure Events During the Study|Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any non-fatal MI over time. Percentage of observed participants with any non-fatal MI (positively adjudicated by CEC in a blinded fashion) were reported.|From randomization up to 64 months|ITT Population.|||percentage of participants|||Number
2651217|NCT01663402|Secondary|Time to All-Cause Death; Percentage of Observed Participants With Outcome Measure Events During the Study|Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the all-cause death over time. Percentage of observed participants with all-cause death (positively adjudicated by CEC in a blinded fashion) were reported.|From randomization up to 64 months|ITT Population.|||percentage of participants|||Number
2651220|NCT01663402|Secondary|Time to First Occurrence of All-Cause Mortality, Non-Fatal Myocardial Infarction, Non-Fatal Ischemic Stroke; Percentage of Observed Participants With Outcome Measure Events During the Study|All-cause mortality, non-fatal MI and non-fatal IS positively adjudicated by CEC in a blinded fashion, were used in the analysis of this endpoint. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of all-cause mortality, non-fatal MI and non-fatal IS over time. Percentage of observed participants with outcome measure events during the study were reported.|From randomization up to 64 months|ITT Population.|||percentage of participants|||Number
2651221|NCT01663402|Secondary|Time to First Occurrence of Any Cardiovascular Event; Percentage of Observed Participants With Outcome Measure Events During the Study|All CV events positively adjudicated by CEC in a blinded fashion, were used in the analysis of the composite CV endpoint comprised of any non-fatal CHD event, any CV death and non-fatal IS. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any CV event over time. Percentage of observed participants with outcome measure events during the study were reported.|From randomization up to 64 months|ITT Population.|||percentage of participants|||Number
2651222|NCT01663402|Secondary|Time to First Occurrence of Any Major Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study|All Major CHD events positively adjudicated by CEC in a blinded fashion, were used in the analysis of the composite CHD endpoint comprised of any CHD death and non-fatal MI. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any major CHD event over time. Percentage of observed participants with outcome measure events during the study were reported.|From randomization up to 64 months|ITT Population.|||percentage of participants|||Number
2651223|NCT01663402|Secondary|Time to First Occurrence of Any Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study|All CHD events positively adjudicated by CEC in a blinded fashion, were used in the analysis of the composite CHD endpoint comprised of any CHD death, non-fatal non-fatal MI, UA requiring hospitalization, or ischemia-driven coronary revascularization procedure. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of any CHD event over time. Percentage of observed participants with outcome measure events during the study were reported.|From randomization up to 64 months|ITT Population.|||percentage of participants|||Number
2651224|NCT01663402|Primary|Time to First Occurrence of Major Adverse Cardiovascular Event (MACE); Percentage of Observed Participants With Outcome Measure Events During the Study|All MACE positively adjudicated by Clinical Events Committee (CEC) in a blinded fashion, were used in the analysis of the composite cardiovascular (CV) outcome measure comprised of Coronary Heart Disease (CHD) death, non-fatal Myocardial Infarction (MI), fatal and non-fatal ischemic stroke (IS), or unstable angina (UA) requiring hospitalization. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the first occurrence of MACE over time. Percentage of observed participants with outcome measure events during the study were reported.|From randomization up to 64 months|Intent-to-treat (ITT) population included all randomized participants.|||percentage of participants|||Number
2651225|NCT01663363|Secondary|Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better||6 Months|Percentage of eyes with UCVA of 20/40 or better. Target for this outcome measure is greater than 85% achieving UCVA of 20/40 or Better. Data from 334 eyes of 170 participants are included for the outcome measure “Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better“.|||percentage of eyes|Participants|95% Confidence Interval|Number
2651226|NCT01663363|Primary|Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)||6 Months|"Data from 334 eyes of 170 participants are included for the outcome measure Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)."|||percentage of eyes|Participants|95% Confidence Interval|Number
2651227|NCT01663285|Secondary|Number of Participants With Adverse Events|The safety of neoadjuvant chemotherapy.|9 years|Due to poor patient enrollment this outcome was not able to be analyzed.||||||
2651228|NCT01663285|Secondary|Number of Patients With Pathologic T0/Tis/Ta N0.|The proportion of patients with pathologic T0/Tis/Ta N0.|51 months|Due to poor patient enrollment this outcome was not able to be analyzed.||||||
2651229|NCT01663285|Primary|Recurrence-free Survival Time|The 2-year recurrence-free survival (RFS) time for patients treated with neoadjuvant cisplatin and gemcitabine chemotherapy followed by surgery in high risk upper tract urothelial carcinoma.|2 years after participant surgery|Due to poor patient enrollment the primary objective was not able to be analyzed.||||||
2651230|NCT01663272|Secondary|Median Progression-free Survival (PFS)|Progression-free survival (PFS, a secondary endpoint) will be calculated from day-7 of cycle 1 of study treatment, until documented disease progression or death. Patients removed from treatment for progression or other reasons will be followed for 30 days after their last dose.|day-7 of cycle 1 until 30 days post treatment||||months||95% Confidence Interval|Median
2651231|NCT01663272|Primary|Maximum Tolerated Dose|The MTD is defined at the highest dose level at which ≤25% of patients experience a dose-limiting toxicity (DLT).|5 weeks||||mg|||Number
2651232|NCT01663233|Secondary|Number of Participants With Adverse Event|Participants were monitored for adverse events, serious adverse events and death.|8 weeks|Safety Set: The safety set included all randomized participants who received at least one dose of study medication.|||Participants|||Number
2651233|NCT01663233|Secondary|Number of Participants Achieving Successful Response in msDBP (< 90 mmHg or a Reduction ≥ 10 mmHg From Baseline)|The number of participants who achieved successful treatment response in msDBP of < 90mmHg or a reduction ≥ 10mmHg from baseline after completing study treatment was measured. Participants who achieved either of the above targets were deemed as having a successful response.|8 weeks of treatment|FAS|||Participants|||Number
2651234|NCT01663233|Secondary|Number of Participants Achieving Successful Response in msSBP (< 140 mmHg or a Reduction ≥ 20 mmHg From Baseline)|The number of participants who achieved successful treatment response in the msSBP of < 140mmHg or a reduction ≥ 20 mmHg from baseline after completing study treatment was measured. Participants who achieved either of the above targets were deemed as a having a successful response.|8 weeks|FAS|||Participants|||Number
2654704|NCT01633853|Secondary|The Blood 25(OH)Vitamin D Level.|The levels of blood 25(OH)Vitamin D at the 24th month of following up.|24 months||||ng/ml||Standard Deviation|Mean
2651235|NCT01663233|Secondary|Number of Participants Achieving Systolic and Diastolic Blood Pressure Control (< 140/90 mmHg)|The number of participants achieving a systolic and diastolic blood pressure < 140/90 mmHg was measured. This outcome measure shows how well a given blood pressure treatment can achieve a given blood pressure target or goal. Participants who achieved the target blood pressure were determined based on the mean SBP and DBP measurements taken at the end of the study. If the participants' BP measurement was below the above target, they were considered to have successful blood pressure control.|8 weeks|FAS|||Participants|||Number
2651236|NCT01663233|Secondary|Change in Sitting Pulse Pressure (PP)|The change in the patient's mean sitting PP from baseline to end of the study was measured. Pulse pressure measures the difference in mean sitting systolic blood pressure and mean sitting diastolic blood pressure.|8 weeks|FAS|||mmHg||Standard Error|Least Squares Mean
2651237|NCT01663233|Secondary|Change in Mean Sitting Diastolic Blood Pressure (msDBP)|The change in the patient's msDBP from baseline to end of the study was measured. A reduction from baseline indicates a positive treatment effect.|8 weeks|FAS|||mmHg||Standard Error|Least Squares Mean
2651238|NCT01663233|Secondary|Change in Mean Sitting Systolic Blood Pressure (msSBP)|The change in the patient's msSBP from baseline to end of the study was measured. A reduction from baseline indicates a positive treatment effect.|8 weeks|FAS|||mmHg||Standard Error|Least Squares Mean
2651239|NCT01663233|Secondary|Change in Mean 24-hour ABPM Diastolic Blood Pressure (maDBP)|The change in mean 24 hour maDBP from baseline to end of the study was measured. A reduction from baseline indicates a positive treatment effect.|8 weeks|FAS: This set included all randomized participants who received at least one dose of study medication. Among the 266 Full Analysis Set (FAS) participants, 251 participants (123 participants in the LCZ696 + amlodipine group and 128 participants in the amlodipine group) had eligible ABPM at both baseline and endpoint.|||mmHg||Standard Error|Least Squares Mean
2651240|NCT01663233|Primary|Change in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (maSBP)|The change in mean 24 hour ambulatory systolic blood pressure (maSBP) from baseline to end of the study (week 8) in the 2 groups was measured. A greater reduction from baseline in the LCZ696 group indicates a positive treatment effect.|8 weeks|FAS: This set included all randomized participants who received at least one dose of study medication. Among the 266 Full Analysis Set (FAS) participants, 251 participants (123 participants in the LCZ696 + amlodipine group and 128 participants in the amlodipine group) had eligible ABPM at both baseline and endpoint.|||mmHg||Standard Error|Least Squares Mean
2651241|NCT01663103|Other Pre-specified|Change in Vascular Endothelial NADPH Oxidase Expression|Vascular endothelial cells will be collected and assessed for changes in protein expression of NADPH oxidase after 3 months of treatment with rilonacept vs. placebo. Protein expression is calculated as a ratio of intensity of staining in the patient cells relative to human umbilical vein endothelial cell (HUVEC) control cells. The absolute change in this ratio between baseline and week 12 is reported below.|3 months after start of treatment|sub-group from Denver site|||absolute change in ratio||Standard Deviation|Mean
2651242|NCT01663103|Other Pre-specified|Change in High-sensitivity C-reactive Protein (hsCRP)|Change in high-sensitivity C-reactive protein (hsCRP) after 3 months of rilonacept vs. placebo will be assessed as a circulating marker of inflammation.|3 months after start of treatment||||change in c-reactive protein (mg/L)||Inter-Quartile Range|Median
2651243|NCT01663103|Secondary|Change in Contribution of Oxidative Stress to FMD|FMD will be assessed following acute infusion of ascorbic acid compared to saline. The improvement in FMD with ascorbic acid reflects the degree of oxidative stress contributing to impairment in FMD.|3 months after start of treatment|sub-group from Denver site|||change in percent flow-mediated dilation||Standard Deviation|Mean
2651244|NCT01663103|Secondary|Change in Aortic Pulse-wave Velocity (aPWV)|Change in aPWV after 3 months of treatment with rilonacept will be compared to change in the placebo group.|3 months after start of treatment||||change in pulse-wave velocity (cm/sec)||Standard Deviation|Mean
2651245|NCT01663103|Primary|Change in Flow-mediated Dilation (FMD)|Change in FMD after 3 months of treatment with rilonacept will be compared to change in the placebo group.|3 months after start of treatment||||change in percent flow-mediated dilation||Standard Deviation|Mean
2651246|NCT01663012|Secondary|Overall Survival From Time of Diagnosis|Will be described using Kaplan-Meier estimates.|From date of pathologic diagnosis/confirmation of high grade glioma to date of death, assessed up to 2 years.||||Months||95% Confidence Interval|Median
2651247|NCT01663012|Secondary|Survival From the Time of First NKTR-102 Dose for Patients With BEV-resistant Glioma Receiving NKTR-102 to Date of Death|Will be described using Kaplan-Meier estimates.|From date of first dose of NKTR-102 to date of death, assessed up to 2 years||||Months||95% Confidence Interval|Median
2651248|NCT01663012|Primary|Progression Free Survival, Assessed by Revised Assessment in Neuro-oncology (RANO) Criteria|Will be described using Kaplan-Meier estimates. The PFS probability at 6 weeks (PFS-6week) will be estimated with an 80% power and 95% confidence intervals (80% in accord with the planned alpha level, 95% for comparability with other studies, confidence intervals based on the Greenwood formula for the variance of a survival probability).|6 weeks from first administration of NKTR-102||||participants|||Number
2651249|NCT01662999|Secondary|Number of Participants With Change From Baseline in ECG Interval - Safety Population|A 12-Lead electrocardiogram (ECG) was performed and recorded after the participant had been supine for at least 5 minutes. ECGs done at baseline (Day-1 of Period 1) and at end of study; therefore the results are presented by sequence, and cannot be presented by treatment. QT interval (measure between Q wave and T wave in the heart's electrical cycle); and QT interval corrected for heart rate using Fridericia's formula (QTcF) were measured in milliseconds (msec). Abnormality criteria: QT/QTcF QT or QTcF >450 msec and <=480 msec at any postdose time point and not present at baseline. QT or QTcF >480 msec and <=500 msec at any postdose time point and not present at baseline QT or QTcF >500 msec at any postdose time point and not present at baseline. QT/QTcF Increase from baseline >60 msec for at least 1 postdose measurement. Increase from baseline in QT or QTcF >30 msec for at least 1 postdose measurement, but <=60 msec for all postdose measurements.|Baseline to end of study (16 days)|Safety Population = All participants who received at least one dose of any study drug.|||participants|||Number
2651768|NCT01658904|Secondary|Evaluate the Immune Reconstitution Post-Pre-autologous Hematopoietic Cell Transplantation (AHCT) Following Carfilzomib (CFZ) Therapy||Post-AHCT following CFZ therapy|This outcome measure was not done because the study was closed prematurely because the investigator left the National Institutes of Health.||||||
2651250|NCT01662999|Secondary|Number of Participants With Marked Urinalysis Laboratory Abnormalities - Safety Population|Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period. Fasted for 10 hours prior to samples taken. LLN=lower limit of normal; ULN=upper limit of normal; pretreatment (Pre-Rx). Normals: Urine glucose qualitative: dipstick >=1 if Pre-Rx <1 or 2*Pre-Rx if Pre-Rx>=1; urine microscopic white blood cell count (WBC): >=2 if Pre-Rx <2 or >=4 if Pre-Rx >=2;urine red blood cell count (RBC):>=2 if Pre-Rx <2 or >=4 if Pre-Rx >=2.|Baseline to Day 1 of each period|Safety Population = All participants who received at least one dose of any study drug. Urine WBC and RBC were not done for all 42 participants. Number of participants analyzed (N) for the 3 treatments for WBC/RBC urine were 4, 8, 6, in treatment A, B, C, respectively.|||participants|||Number
2651251|NCT01662999|Secondary|Number of Participants With Marked Chemistry Laboratory Abnormalities - Safety Population|Fasted for 10 hours prior to samples taken. Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period. Lower limit of normal(LLN); upper limit of normal (ULN); pre-treatment(Pre-Rx). Alkaline phosphatase U/L:>1.25*Pre-RX if Pre-Rx >ULN or >1.25*ULN if Pre-Rx <=ULN; aspartate aminotransferase (AST) U/L: >1.25*Pre-Rx if Pre-Rx > ULN or 1.25*ULN if Pre-Rx <= ULN;alanine aminotransferase (ALT) U/L: >1.25*Pre-Rx if Pre-Rx>ULN or 1.25*ULN if Pre-Rx<=ULN;blood urea nitrogen (BUN)mmol/L: >1.1*ULN if Pre-Rx <=ULN or >1.2*Pre-Rx if Pre-Rx >ULN; total bilirubin µmol/L: >1.1*ULN if Pre-Rx <=ULN or >1.25*Pre-Rx if Pre-Rx >ULN;direct bilirubin µmol/L: >1.1*ULN if Pre-Rx <= ULN or >1.25*Pre-Rx if Pre-Rx > ULN; creatine phosphokinase (CK) U/L: >1.5*Pre-Rx if Pre-Rx >ULN or >1.5*ULN if Pre-Rx <= ULN.|Baseline to Day 1 in each period|Safety Population = All participants who received at least one dose of any study drug.|||participants|||Number
2651252|NCT01662999|Secondary|Mean Change From Baseline in Temperature - Safety Population|Participant had their temperature taken after quietly sitting for at least 5 minutes and it was measured as degrees of centigrade (C). Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period.|Baseline to Day 1 in each period|Safety Population = All participants who received at least one dose of any study drug.|||degrees of centigrade||Standard Deviation|Mean
2651253|NCT01662999|Secondary|Mean Change From Baseline in Respiration Rate - Safety Population|Respiration rates were taken while the participant was sitting quietly for at least 5 minutes and were measured in breaths per minute (bpm). Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period.|Baseline to Day 1 in each period||||bpm||Standard Deviation|Mean
2651254|NCT01662999|Secondary|Mean Change From Baseline in Heart Rate - Safety Population|Heart rates were taken while the participant was sitting quietly for at least 5 minutes and were measured in beats per minute (bpm). Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period.|Baseline to Day 1 in each period|Safety Population = All participants who received at least one dose of any study drug.|||bpm||Standard Deviation|Mean
2651255|NCT01662999|Secondary|Mean Change From Baseline in Systolic and Diastolic Blood Pressure - Safety Population|Blood pressure was taken while the participant was quietly seated for at least 5 minutes. Blood pressure was measured in millimeters of mercury (mmHg). Baseline was Day -1 in Period 1; study drug was administered on Day 1 of each crossover period.|Baseline to Day 1 of each period|Safety Population = All participants who received at least one dose of any study drug.|||mmHg||Standard Deviation|Mean
2651256|NCT01662999|Secondary|Number of Participants With Marked Hematology Laboratory Abnormalities - Safety Population|Fasted for 10 hours prior to samples taken. Baseline was Day -1 of Period 1; study drug was administered on Day 1 of each crossover period. Lower limit of normal (LLN); upper limit of normal (ULN); pretreatment(pre-RX); treatment (RX). Hemoglobin (g/L): <0.85* pre-RX; hematocrit (vol): <0.85*pre-RX; erythrocytes (*10^12 c/L): <0.85*pre-RX; platelet count (*10^9 c/L): <0.85*LLN if pre-RX>=LLN, or if Pre-Tx <LLN; leukocytes (*10^9 c/L): <0.85*LLN if pre-RX <LLN,or <0.9*LLN if LLN<=Pre-RX<=ULN; neutrophils+bands (*10^9 c/L): <0.85*Pre-RX if Pre-RX <1.5 or <1.5 if Pre-RX >=1.5; eosinophils (*10^9 c/L): if value >0.75; basophils (*10^9 c/L): if value >0.4; monocytes (*10^9c/L): if value >2; lymphocytes (*10^9 c/L): if value <0.750 or if value >7.50.|Baseline to Day 1 of each period|Safety Population = All participants who received at least one dose of any study drug.|||participants|||Number
2651257|NCT01662999|Secondary|Number of Participants With Deaths, Serious Adverse Events, Adverse Events, or Discontinuations Due to Adverse Events - Safety Population|Adverse event (AE)=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE)=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. End of study was approximately 16 days and was the time for a participant to conclude each of the 3 periods (including the 6 day washout between periods).|Day 1 to end of study (16 days)|Safety Population = All participants who received at least one dose of any study drug.|||participants|||Number
2651258|NCT01662999|Secondary|Metabolite to Parent Molar Ratios (MR) of Cmax, AUC(INF), and AUC(0-T) of 5-OH Saxagliptin and Saxagliptin From a Single Dose 5 mg Saxagliptin Versus MR of Saxagliptin and 5-OH When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Saxagliptin is the parent drug and 5-OH saxagliptin is the metabolite. The molecular weights to be used for the molar ratios were 315.42 and 331.42 for saxagliptin and 5-OH, respectively. Plasma samples were analyzed for saxagliptin and for 5-OH by LC-MS/MS using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL and 0.200 ng/mL to 100.0 ng/mL for saxagliptin and 5-OH, respectively).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||Molar ratio||Geometric Coefficient of Variation|Geometric Mean
2651293|NCT01662960|Primary|Action Research Arm Test|The test measures the ability to complete simulated everyday tasks with the arm. Scores range from 0 to 54, with higher scores indicating better performance.|1 month|All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.|||score on a scale||Standard Deviation|Mean
2651259|NCT01662999|Secondary|Half-life (T-HALF) of Saxagliptin, and 5-OH Saxagliptin From Single Dose 5 mg Saxagliptin Versus T-HALF of Saxagliptin and 5-OH From Co-administered Saxagliptin With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by LC-MS/MS using a validated method. T-HALF was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in hours (h).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||h||Standard Deviation|Mean
2651260|NCT01662999|Secondary|Tmax of Saxagliptin, 5-OH Saxagliptin, Saxagliptin Total Active Moiety From a Single Dose of Saxagliptin Versus Tmax of Saxagliptin, 5-OH, Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin and 5-OH by LC-MS/MS using a validated method. Tmax was derived from the plasma concentration versus time profile for study drug and was measured in hours (h). Saxagliptin was the drug, 5-OH saxagliptin was the metabolite, and Saxagliptin total Active Moiety was molar summations of saxagliptin exposure parameter with one-half the molar exposure parameters for 5-OH Saxagliptin.|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||h||Full Range|Median
2651261|NCT01662999|Secondary|AUC(INF) and AUC(0-T) of the Saxagliptin Total Active Moiety From a Single Dose 5 mg Saxagliptin Versus AUC(INF) and AUC(0-T) of Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by LC-MS/MS using a validated method. AUC(INF) is area under the plasma concentration-time curve from time zero extrapolated to infinity; AUC(0-T) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method) and both were derived from the plasma concentration versus time profile using a validated PK analysis program ™. Total moiety (molar summations of saxagliptin exposure parameter with one-half the molar exposure parameters for 5-OH Saxagliptin), AUC(0-T)and AUC(INF) were measured in nano Molars*hours (nM*h).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||nM*h||Geometric Coefficient of Variation|Geometric Mean
2651262|NCT01662999|Secondary|Cmax of the Saxagliptin Total Active Moiety From a Single Dose of 5 mg Saxagliptin Versus Cmax of Saxagliptin Total Active Moiety When Saxagliptin Was Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Cmax of saxagliptin total active moiety (molar summations of saxagliptin exposure parameter with one-half the molar exposure parameters for 5-OH Saxagliptin) was derived from the plasma concentration versus time profile for the saxagliptin total active moiety. Measurement was in nano Molars (nM).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||nM||Geometric Coefficient of Variation|Geometric Mean
2651263|NCT01662999|Secondary|AUC(INF) of 5-OH Saxagliptin From a Single Dose Saxagliptin Versus AUC(INF) of 5-OH When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for 5-OH by LC-MS/MS using a validated method (quantitation range of 0.200 ng/mL to 100.0 ng/mL). AUC(INF) was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2651264|NCT01662999|Secondary|AUC(0-T) of 5-OH Saxagliptin From Single Dose Saxagliptin Versus AUC(0-T) of 5-OH From Saxagliptin Co-administered With Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for 5-OH by LC-MS/MS using a validated method (quantitation range of 0.200 ng/mL to 100.0 ng/mL). AUC(0-T) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method)and was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™. AUC (0-T) was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2651265|NCT01662999|Primary|AUC(INF) of Saxagliptin From a Single Dose of 5 mg Saxagliptin Versus AUC(INF) of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by LC-MS/MS using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL). AUC(INF) was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2651324|NCT01662778|Secondary|Spirometry|FEV1 and FVC will be measured before and after drug administration|0 and 4 hours|Data not collected||||||
2651266|NCT01662999|Primary|AUC(0-T) of Saxagliptin From Single Dose 5 mg Saxagliptin Versus AUC(0-T) of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by Liquid chromatography-Mass Spectrometry (LC-MS/MS) using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL). AUC(0-T), the area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method) was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2651267|NCT01662999|Secondary|Cmax of 5-Hydroxy (5-OH) Saxagliptin From a Single Dose Saxagliptin Versus Cmax of 5-OH When Saxagliptin Was Co-administered With Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for 5-OH by LC-MS/MS using a validated method (quantitation range of 0.200 ng/mL to 100.0 ng/mL). Actual sampling times were used for PK calculations. Cmax for 5-OH Saxagliptin (the major active metabolite of Saxagliptin) was derived from plasma concentration versus time data using a validated PK analysis program ™ and was measured in ng/mL.|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2651268|NCT01662999|Secondary|Plasma Apparent Clearance (CLT/F) of a Single Dose of Dapagliflozin Versus CLT/F of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method. Actual sampling times were used for PK calculations. CLT/F was calculated as Dose/AUC(INF)and was measured in milliliters per minute (mL/min).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. One participant in the ACB treatment sequence withdrew consent after having received all 3 treatments; this participant did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B).|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2651269|NCT01662999|Primary|Maximum Observed Concentration (Cmax) of a Single Dose of 5 mg Saxagliptin Versus Cmax of Saxagliptin When Co-administered With 10 mg Dapagliflozin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for saxagliptin by Liquid chromatography-Mass Spectrometry (LC-MS/MS) using a validated method (quantitation range of 0.100 ng/mL to 50.0 ng/mL). Cmax for Saxagliptin was derived from plasma concentration versus time data using a validated PK analysis program ™ and was measured in nanograms per milliliter (ng/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2651270|NCT01662999|Secondary|Half-life (T-HALF) of Dapagliflozin From a Single Dose of Dapagliflozin Versus T-Half of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method. Actual sampling times were used for PK calculations. T-HALF was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in hours.|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. 1 participant (ACB treatment sequence) withdrew consent after having received all 3 treatments and did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B). This did not impact T-HALF.|||hours||Standard Deviation|Mean
2651271|NCT01662999|Primary|Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration AUC(0-T) of Dapagliflozin From a Single Dose of 10 mg Dapagliflozin Versus AUC(0-T) for Dapagliflozin When Co-administered With 5 mg Saxagliptin|AUC(0-T) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (linear up/log down trapezoidal method). Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method; nominal range of 0.200 to 100 nanograms per milliliter (ng/mL). Actual sampling times were used for PK calculations. AUC(0-T) was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. One participant in the ACB treatment sequence withdrew consent after having received all 3 treatments; this participant did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B).|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2651279|NCT01662986|Secondary|Exposure of COPD Exacerbation Events From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Total patient year exposure of COPD was calculated by aggregating the time to min(treatment stop +30, last contact) for on-treatment analysis, or time to last contact for on-study analysis.|start of treatment to the last timepoint with information of clinical adverse outcome available,Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 73 for Placebo and 54 for Tiotropium.|||Patient years|||Number
2654705|NCT01633853|Primary|The Blood Levels of Calcium at the 24th Month of Following up.|The blood levels of calcium at the 24th month of following up will be detected.|24 months||||mmol/L||Standard Deviation|Mean
2651272|NCT01662999|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin From a Single Dose of 10 mg Dapagliflozin Versus Tmax of Dapagliflozin When Co-administered With 5 mg Saxagliptin - PK Evaluable Population|Serial blood samples for determination of study drug were collected predose (0 h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method. Actual sampling times were used for PK calculations. Tmax was derived from the plasma concentration versus time profile using a validated PK analysis program ™ and was measured in hours.|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. 1 participant (ACB treatment sequence) withdrew consent after having received all 3 treatments and did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B). This did not impact T-HALF.|||hours||Full Range|Median
2651273|NCT01662999|Primary|Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity [AUC(INF)] of Dapagliflozin From a Single Dose of Dapagliflozin Versus AUC (INF) of Dapagliflozin When Co-administered With Saxagliptin - PK Evaluable Population|AUC(INF) is area under the plasma concentration-time curve from time 0 extrapolated to infinity. Serial blood samples for determination of study drug were collected predose (0 hours (h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h and 60 h postdose, relative to dosing on Day 1 in each cross over period. Plasma samples were analyzed for dapagliflozin by HPLC-MS/MS using a validated method; nominal range of 0.200 to 100 nanograms per milliliter (ng/mL). Actual sampling times were used for PK calculations. AUC(INF) was derived from the plasma concentration versus time profile for study drug using a validated PK analysis program ™ and was measured in nanograms*hours per milliliter (ng*h/mL).|Day 1 (0h to 60h post dose) in each period|PK Evaluable Population: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. One participant in the ACB treatment sequence withdrew consent after having received all 3 treatments; this participant did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B).|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2651274|NCT01662999|Primary|Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin From a Single Dose of Dapagliflozin Versus Cmax of Dapagliflozin From Co-administered Saxagliptin Plus Dapagliflozin - Pharmacokinetic Evaluable Population|The geometric mean of the maximum observed plasma concentration (Cmax) is presented below; serial blood samples for determination of study drug were collected predose (0 hours (h), 6 h, 12 h, 18 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h,and 60 h postdose, relative to dosing on Day 1 in each cross over period and these data are summarized in the Pharmacokinetic (PK) parameter of Cmax presented here. Plasma samples were analyzed for dapagliflozin by High Performance Liquid chromatography-Mass Spectrometry (HPLC-MS/MS) using a validated method; nominal range of 0.200 to 100 nanograms per milliliter (ng/mL). Dapagliflozin Cmax was derived from plasma concentration versus time data using a non-compartmental method, using a validated PK analysis program ™. Actual sampling times were used for PK calculations. Cmax was reported in ng/mL.|Day 1 (0 h to 60 h post dose) in each period|Pharmacokinetic (PK) Evaluable: All participants who received at least 1 dose of any study drug and had at least 1 valid PK parameter for at least 1 analyte. One participant in the ACB treatment sequence withdrew consent after having received all 3 treatments; this participant did not provide 36-, 48-, or 60-hour samples in Period 3 (Treatment B).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2651275|NCT01662986|Secondary|Time to Event: Time to Recovery (EXACT-PRO) From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|"Time to event: Time to recovery based on EXACT-PRO total score. The percentage of observed patients recovered by end of study was reported.~Time to recovery was assessed with the EXACT-PRO questionnaire. EXACT-PRO total scores were transformed to smooth scores for determining time to recovery and all other endpoints related to the EXACT questionnaire. The day-2 score was transformed to the mean of the total scores recorded on Day 1, 2, and 3. Similarly, each subsequent day's score was transformed to the mean score using a rolling 3-day average.~Analysis based on Kaplan Meier estimate"|from first drug administration to the last timepoint with information of EXACT-PRO, Up to 2 years|Patients who had baseline and post-baseline measurements of EXACT-PRO.|||Percentage of patients recovered|||Number
2651276|NCT01662986|Secondary|Exposure of All-cause Hospitalization Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Total patient year exposure of all-cause hospitalization was calculated by aggregating the time to min(treatment stop +30, last contact) for on-treatment analysis, or time to last contact for on-study analysis.|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 47 for Placebo and 38 for Tiotropium.|||patient years|||Number
2651277|NCT01662986|Secondary|Number of All-cause Hospitalization Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Number of all-cause hospitalization per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 47 for Placebo and 38 for Tiotropium.|||hospitalizations per patient year|||Number
2651278|NCT01662986|Primary|Percentage of Patients With Next Adverse Clinical Outcome Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987).|"Percentage (number) of patients with next adverse clinical outcome event occured during the study, defined as the combined endpoint of Chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality.~Time to the next adverse clinical outcome event from the Two Twin Trials, present 205.478 (NCT01662986) and 205.477 (NCT01663987) was not analysed, only Kaplan Meier curve was plotted. So this endpoint has not been disclosed.~This endpoint was analysed using combined data, as specified in the analysis plan"|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477 : This set includes all patients who were randomized and took at least one dose of the study drug, 157 patients (79 tiotropium and 78 placebo) were included in this set.|||Percentage of participants|||Number
2651280|NCT01662986|Secondary|Number of COPD Exacerbation Events From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Number of COPD exacerbation per patient year outcome event occured during the study was analysed descriptively by calculating average occurrence (number of events per patient year drug exposure) by treatment group for on study period using the TS.|start of treatment to the last timepoint with information of clinical adverse outcome available,Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed for this endpoint from the treated set were 73 for Placebo and 54 for Tiotropium.|||exacerbations per patient year|||Number
2651281|NCT01662986|Secondary|Percentage of Patients With 30-day Hospital Readmission Rates Outcome Event From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|"Percentage (number) of patients with 30-day hospital readmission rates outcome events was analysed.~Days to hospital readmission were calculated as:Hospital readmission days = Readmission date - Date of hospital discharge + 1.~The 30-day hospital readmission analysis summarized the frequency of patients with hospital readmission and readmission days >1 and <31 days using the TS."|from date of hospital discharge prior to randomization upto readmission days >1 and <31 days|Treated Set of the pooled twin studies 205.478 and 205.477|||percentage of participants|||Number
2651282|NCT01662986|Secondary|Percentage of Patients With All-cause Hospitalization From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987).|"Percentage (number) of patients with all-cause hospitalization outcome event occured during the study was analysed for the combined study.~All-cause hospitalization included all hospitalizations, except planned hospitalizations for elective procedures.~Hospitalizations occurring on the same day as discharge were not considered a separate admission."|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477|||percentage of participants|||Number
2651283|NCT01662986|Secondary|Percentage of Patients With COPD Exacerbation From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|"Percentage (number) of patients with COPD exacerbation on study was analysed for the combined study.~A COPD exacerbation was defined as a complex of lower respiratory events/symptoms (increase or new onset) related to the underlying COPD with duration of three days or more, requiring a change in treatment where a complex of lower respiratory events/symptoms was defined as at least two of the following:~1) Shortness of breath; 2) Sputum production (volume) ; 3) Occurrence of purulent sputum; 4) Cough; 5) Wheezing; 6) Chest tightness.~Onset of exacerbation was defined by the onset of first recorded symptom.The end of exacerbation was decided by the investigator based on clinical judgment.~A required change in treatment included either prescription of antibiotics and/or systemic steroids; and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines and PDE4-inhibitors)."|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set of the pooled twin studies 205.478 and 205.477|||percentage of participants|||Number
2651284|NCT01662986|Secondary|Change From Baseline of Trough FVC at 12 Weeks From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.|Baseline and week 12|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed at week 12 from the treated set were 59 for Placebo and 60 for Tiotropium.|||Litres||Standard Deviation|Mean
2651285|NCT01662986|Secondary|Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug From the Two Twin Trials, Present 205.478 (NCT01662986) and 205.477 (NCT01663987)|"Change from baseline of trough FEV1 (forced expiratory volume in 1 second) at 12 weeks on study drug.~Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug."|Baseline and week 12|Treated Set of the pooled twin studies 205.478 and 205.477. The number of patients analyzed at week 12 from the treated set were 59 for Placebo and 60 for Tiotropium.|||Litres||Standard Deviation|Mean
2651286|NCT01662986|Secondary|Percentage of Patients With Adverse Clinical Event During on Study.|Percentage (number) of patients with adverse clinical event on study, which is defined as the combined endpoint of Chronic obstructive pulmonary disease (COPD) exacerbations per Boehringer Ingelheim (BI) definition, all-cause re-hospitalization, or all-cause mortality.|from first drug administration to the last timepoint with information of clinical adverse outcome available, Up to 2 years|Treated Set (TS)|||percentage of participants|||Number
2651287|NCT01662986|Secondary|Change From Baseline of Trough FVC at 12 Weeks on Study Drug.|Change from baseline of trough Forced Vital Capacity (FVC) at 12 weeks on study drug.|baseline and 12 weeks|Treated Set (TS). The number of patients analyzed at week 12 from the treated set were 29 for Placebo and 30 for Tiotropium.|||Litres||Standard Deviation|Mean
2651288|NCT01662986|Primary|Change From Baseline of Trough FEV1 at 12 Weeks on Study Drug.|"Change from baseline of trough forced expiratory volume in 1 second (FEV1) at 12 weeks on study drug.~Trough FEV1 is defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after last inhalation of drug."|Baseline and 12 weeks|Treated Set (TS): The treated set included all patients randomized and who took at least one dose of the study drug. The number of patients analyzed at week 12 from the treated set were 29 for Placebo and 30 for Tiotropium.|||Litres||Standard Deviation|Mean
2651289|NCT01662960|Secondary|Wolf Motor Function Test|The test measures the ability to completed simulated everyday tasks with the arm. The scale ranged from 0 to 75, with higher scores indicating better performance.|1 months|All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.|||score on a scale||Standard Deviation|Mean
2651290|NCT01662960|Secondary|Stroke Impact Scale|This test measures the self-reported ability to complete everyday tasks with the arm. Total scores for all items are reported. The scale ranged from 0 to 300, with higher scores indicating higher self-reported ability.|1 month|All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.|||score on a scale||Standard Deviation|Mean
2651291|NCT01662960|Primary|Virtual-reality Assessment of Navigation|This test measures the ability to detect lateralized attention problems in a simulated navigation test. Evidence for lateralized attentional problems was defined as a 20% difference in item detection between the left and right side.|1 month|No participants were administered the test in the post-treatment phase because no participant exhibited a baseline 20% difference in item detection between the left and right side.||||||
2651294|NCT01662960|Primary|Upper Extremity Fugl-Meyer|This test measures impairment-level ability to move the arm and hand. Scores range from 0 to 66, with higher scores indicating greater ability to move the arm and hand.|Immediately after 1 month of treatment|All participants who started the treatment were included. Data for any participants who failed to complete the treatment were imputed.|||score on a scale||Standard Deviation|Mean
2651295|NCT01662908|Secondary|Number of Participants With Change From Baseline in the Presence or Absence of Thrombus by Vessel||Baseline to final visit (Day 14-21)|mITT|||Participants|||Count of Participants
2651296|NCT01662908|Secondary|Number of Participants With Major Adverse Cardiovascular Events (MACE)|MACE is defined as a composite of non-fatal myocardial infarction (MI), non-fatal stroke, non-fatal systemic embolic event (SEE) and cardiovascular death|Initial dose of study drug up to 3 days after last dose|Adjudicated confirmed events in the mITT population|||Participants|||Count of Participants
2651297|NCT01662908|Secondary|Number of Participants With Recurrence of Venous Thromboembolism (VTE)|Number of participants with investigator-confirmed recurrent VTE events that start or worsen after the first dose of study drug and prior to the date of the final visit or telephone contact (inclusive)|Baseline to final visit (Day 14-21)|mITT|||Participants|||Count of Participants
2651298|NCT01662908|Secondary|Number of Participants With Clinically Relevant Bleeding|Clinically relevant bleeding was defined as major or clinically relevant non-major bleeding|Initial dose of study drug up to 3 days after last dose|Adjudicated in the mITT population|||Participants|||Count of Participants
2651299|NCT01662908|Primary|Relative Change From Baseline in Thrombus Volume Assessed by MRI [Using the Magnetic Resonance Venography (MRV) Method]|Thrombus Volume (mm^3) was measured at baseline and between days 14 to 21 using MRI results as determined by Magnetic Resonance Venography (MRV) method, and the relative percentage change from baseline was calculated|Baseline to final visit (Day 14-21)|Modified intention to treat (mITT), defined as intention to treat minus the one patient who did not take the investigational product|||percentage of change||Standard Deviation|Mean
2651300|NCT01662895|Post-Hoc|Number of Subjects With Acute Respiratory Distress Syndrome||90 days||||Participants|||Count of Participants
2651301|NCT01662895|Other Pre-specified|Number of Patients Who Died During the 90-day Study Period|Mortality at any time from randomization through day-90|90 days||||Participants|||Count of Participants
2651302|NCT01662895|Other Pre-specified|Number of Patients With Serious Adverse Events||90 days||||Participants|||Count of Participants
2651303|NCT01662895|Other Pre-specified|Number of Patients With New Visual or Auditory Changes||within 7 days or discharge||||Participants|||Count of Participants
2651304|NCT01662895|Other Pre-specified|Number of Patients With Hypotension||within 7 days or discharge||||Participants|||Count of Participants
2651305|NCT01662895|Other Pre-specified|Number of Subjects With Allergic/Anaphylactic Reaction||within 7 days or discharge||||Participants|||Count of Participants
2651306|NCT01662895|Secondary|Number of Subjects With mRS Score 0-3|The proportion of DFO- and placebo-treated subjects with mRS 0-3 vs. 4-6 at 90 days|90 days||||Participants|||Count of Participants
2651307|NCT01662895|Primary|Number of Subjects With Modified Rankin Scale (mRS) Score 0-2|"The primary outcome measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 90 days.~The minimum mRS score is 0 (i.e. no disability). The maximum score is 6 (i.e. dead)."|90 days||||Participants|||Count of Participants
2651308|NCT01662882|Primary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.|50-60 min after injection||||SUVR||Standard Deviation|Mean
2651309|NCT01662882|Primary|Qualitative Amyloid Image Assessment|Five readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.|50-60 min after injection||||participants|||Number
2651310|NCT01662856|Secondary|Prevalence of Treatment Failures|Protocol-defined bleeding at the target bleeding site after the start of treatment or the use of alternative hemostatic treatments (with exception of reversal of heparin) or maneuvers at the target bleeding site after the start of treatment.|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study|||percent of subjects|||Number
2651311|NCT01662856|Secondary|Cumulative Proportion of Subjects Having Achieved Hemostasis at the Target Bleeding Site by Specified Time Points|"Cumulative proportion of subjects having achieved hemostasis by each of the following time points:~At 5 minutes following start of study treatment~At 7 minutes following start of study treatment~At 10 minutes following start of study treatment"|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study|||Percent of subjects achieving hemostasis|||Number
2651312|NCT01662856|Secondary|Time to Hemostasis (TTH)|"Time in minutes for achievement of hemostasis at the target bleeding site measured from the start of treatment until 10 minutes after treatment start.~In the Fibrin Sealant Grifols treatment group, the median TTH was calculated based on the estimated survival function S(t), and it is the smallest time at which S(t) is at or below 50%. The 95% CI for the median TTH, on the other hand, was calculated based on the CI for the survival function S(t). The 95% CI for the median TTH was the set of all time points for which the 95% CI of the survival function contains 0.5 (since median is the 50% percentile). Sometimes, the confidence limits for the median cannot be estimated. In our case, the hemostasis was assessed on a discrete scale, and it happened that for all the time points assessed none of the 95% CI of the survival function S(t) contained 0.5. As a result, neither the lower nor the upper limit could be estimated.~All calculations were performed using SAS PROC LIFETEST"|From start of treatment until 10 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study|||minutes||95% Confidence Interval|Median
2651313|NCT01662856|Primary|Proportion of Subjects Achieving Hemostasis by Four Minutes After Treatment Start|Subjects achieving hemostasis at the target bleeding site by 4 minutes following the start of treatment without the occurrence of re-bleeding until the completion of surgical closure.|From start of treatment until 4 minutes after treatment start|Efficacy analysis was performed on subjects in the Primary Part (II) of the study|||Percent of subjects achieving hemostasis|||Number
2651314|NCT01662791|Secondary|Paffenbarger Physical Activity Questionnaire (PPAQ)|"The PPAQ is a validated, self-administered questionnaire that asks for a recall of physical activity of physical activity over the previous 1-week. From the answers to the questions, a physical activity index (PAI) can be computed, providing an estimate of energy expenditure in kcal/week.~The PAI can be estimated using a list of the physical activities a person performs within a time period and the amount of time spent on each activity, e.g. walking to work, light housework, swimming, carrying bricks at work, or whatever applies to an individual person. There is a value called the physical activity ratio for each activity. The list of activities is used to find the relevant values of physical activity ratios, then an overall physical activity level value for the time period is calculated, using time-weighted averages of the physical activity ratios.~This assessment was only measured at baseline."|Baseline||||kcal/week||Standard Deviation|Mean
2651315|NCT01662791|Secondary|Weight Change in Case Group After Treatment|Weight change after treatment|baseline, 3 months||||participants|||Number
2651316|NCT01662791|Other Pre-specified|Calories Consumed From Brief Block Food Frequency Questionnaire (FFQ)|"The FFQ is a validated, self-administered semi-quantitative questionnaire used to assess differences in macronutrient, and energy intake. It was designed to provide estimates of usual and customary dietary intake. This questionnaire contains a food list of about 70 food items.~A Food Frequency Questionnaire (FFQ) is a limited checklist of foods and beverages with a frequency response section for subjects to report how often each item was consumed over a specified period of time. Semi-quantitative FFQs collect portion size information as standardized portions or as a choice of portion sizes. Calculations for nutrient intake or calories can be estimated via computerized software programs that multiply the reported frequency of each food by the amount of nutrient or calories in a serving of that food."|Baseline||||Calories||Standard Deviation|Mean
2651317|NCT01662791|Secondary|Hospital Anxiety and Depression Scale (HADS)|The HADS is a self-administered 14-item questionnaire (seven for anxiety and seven for depression) Items are rated on a 4-point scale from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. The cut-offs used for identifying significant psychiatric distress was >/= 8. This assessment was only measured at baseline|Baseline||||units on a scale||Standard Deviation|Mean
2651318|NCT01662791|Secondary|Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group|The GISSI is a validated, self-administered, multi-dimensional instrument designed to measure the frequency, severity and bothersomeness of individual GI symptoms and to provide subscale scores for interrelated symptom clusters. Factor analyses yielded 5 distinct symptom clusters that were labeled as Constipation/Difficult defecation; Abdominal Pain/Discomfort; Dyspepsia; Diarrhea/Fecal incontinence; Gastroesophageal reflux disease (GERD)/Chest symptoms; and Nausea/Vomiting. Scores could range from 0 to 100, with a higher score indicating greater severity of symptoms.|baseline, 3 months||||units on a scale||Standard Deviation|Mean
2651319|NCT01662791|Secondary|Gastrointestinal Symptom Severity Index (GISSI)|The GISSI is a validated, self-administered, multi-dimensional instrument designed to measure the frequency, severity and bothersomeness of individual GI symptoms and to provide subscale scores for interrelated symptom clusters. Factor analyses yielded 5 distinct symptom clusters that were labeled as Constipation/Difficult defecation; Abdominal Pain/Discomfort; Dyspepsia; Diarrhea/Fecal incontinence; Gastroesophageal reflux disease (GERD)/Chest symptoms; and Nausea/Vomiting. Scores could range from 0 to 100, with a higher score indicating greater severity of symptoms.|Baseline||||units on a scale||Standard Deviation|Mean
2651320|NCT01662791|Secondary|PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group|The PDQ-39 is designed to address aspects of functioning and well-being for those affected by Parkinson's disease. This questionnaire is based on a multi-dimensional model of health. Eight subscale scores may be derived from the items: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communication (3 items), bodily discomfort (3 items). Patients are asked to think about their health and general well-being and to consider how often in the last month they have experienced certain events (e.g. difficulty walking 100 yards). Patients are asked to indicate the frequency of each event by selecting one of 5 options (Likert Scale): Never/occasionally/sometimes/often/always or cannot do at all. Each dimension is calculated as a scale from 0 to 100, with 0= no problem at all; 100= maximum level of problem. Sub-scale score are averaged to calculate the summary index.|Baseline and 3 months||||units on a scale||Standard Deviation|Mean
2651321|NCT01662791|Secondary|PD-specific Quality of Life Questionnaire (PDQ-39)|The PDQ-39 is designed to address aspects of functioning and well-being for those affected by Parkinson's disease. This questionnaire is based on a multi-dimensional model of health. Eight subscale scores may be derived from the items: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communication (3 items), bodily discomfort (3 items). Patients are asked to think about their health and general well-being and to consider how often in the last month they have experienced certain events (e.g. difficulty walking 100 yards). Patients are asked to indicate the frequency of each event by selecting one of 5 options (Likert Scale): Never/occasionally/sometimes/often/always or cannot do at all. Each dimension is calculated as a scale from 0 to 100, with 0= no problem at all; 100= maximum level of problem. Sub-scale score are averaged to calculate the summary index.|baseline||||units on a scale||Standard Deviation|Mean
2651322|NCT01662791|Primary|Number of Subjects With Small Bowel Bacterial Overgrowth (SBBO)|SBBO is measured by the Hydrogen Breath Test, which measures the hydrogen and methane gas produced by bacteria in the small bowel that has diffused into the blood, then lungs for expiration. After an overnight fast, subjects ingested a solution consisting of 50 grams of glucose mixed in 150 mL of water. Immediately before ingestion of glucose and at 20-minute intervals for 2 hours following ingestion, laboratory staff collected end-expiratory breath samples and analyzed them for hydrogen and methane using a Quintron sample correction (SC) breath microlyzer. A diagnosis of SBBO was defined by an increase in expiration of 12 parts per million (ppm) or more of hydrogen and/or methane.|Baseline to 2 hours||||participants|||Number
2651323|NCT01662778|Secondary|Multi-breath Nitrogen Washout Test|At each study visit subjects will breathe in oxygen from a machine, which at the same time will measure the composition of the gases in each exhaled breath. The main gas we are interested in is nitrogen as this makes up the bulk of the air that we breathe. This test is known as the 'multi-breath nitrogen washout'. The test takes 20 minutes and we shall do this at the beginning and at the end of each study visit.|0 and 4 hours|Data not collected||||||
2651326|NCT01662778|Primary|AMP Challenge Test PC20|The concentration of Adenosine Monophosphate (AMP), measured in mg/ml, required to see a 20% fall in the patient's forced expiratory volume in 1 second (FEV1) is measured after taking FP aerosol. AMP is a bronchoconstrictor agent (ie it narrows the airways. We would expect that more would be necessary to produce the same 20% fall in FEV1 after receiving the FP than before due to the reduction in airways inflammation. This change is the primary outcome measure.|2 hours||||mg/ml||Standard Deviation|Mean
2651327|NCT01662765|Other Pre-specified|Costs|from initial treatment to the complete healing, all kind of cost will be calculated.|two year||||USD dollars||Standard Deviation|Mean
2651328|NCT01662765|Secondary|Visual Analogue Scale for Patient Satisfaction (VAS-PS)|"Well-being and satisfaction scales comprised linear metric scales known as visual analogue scales, with grades from 0 (worst imaginable health state and extremely dissatisfied with the treatment) to 100 (best imaginable health state and extremely satisfied with the treatment)."|30 days||||units on a scale||Standard Deviation|Mean
2651329|NCT01662765|Secondary|Healing Time|the time form initial treatment to healing the wound and/or sinus and/or granulation tissue and no any sign of drainage with no longer need for dressing and wound care in either treatment arms.|two year||||days||Standard Deviation|Mean
2651330|NCT01662765|Primary|Cure Rate|"Primary outcome was the cure rate. Absence of recurrence within two year after the first treatment was considered as a cure.~Recurrence was defined as the appearance of a new, active discharging sinus or granulation tissue with/without a bit of hairs in the deep of the umbilicus within two years after therapy."|2 year after initial treatment|Of the 84 patients 41 patients in the CT group. and 40 patients in ST group were analyzed|||participants|||Number
2651331|NCT01662752|Other Pre-specified|Frequency and Tumour-bearing Status of Aberrant SLN(s|To estimate the proportion of patients with aberrant nodal drainage. i.e. the proportion with SLN(s) lying outside the standard resection field|28 days||||Participants|||Count of Participants
2651332|NCT01662752|Secondary|Sensitivity and Specificity of Tumour-bearing Status of SLN(s) as a Measure of Lymph Node Status When Assessed by Standard Techniques|To assess the extent to which that the tumour-bearing status of SLN(s) identified corresponds with lymph node status as assessed by standard methods (pathological examination of excised nodes using H&E and immunohistochemistry)|28 days|There were 10 patients with positive nodes hence this is the denominator for the sensitivity analysis. There were 20 patients with negative lymph nodes overall hence this is the denominator for the specificity analysis.|||Participants|||Count of Participants
2651333|NCT01662752|Primary|Subjects in Which the SLN(s) Are Identified|To establish whether it is possible to identify the first order draining mesocolic lymph nodes (sentinel lymph node(s) (SLNs) in patients with suspected T1 and T2 colonic cancer, using Indocyanine Green (ICG), a fluorescent mapping agent, and a laparoscopic near infrared imaging (NIR) system|28 days||||Participants|||Count of Participants
2651334|NCT01662648|Secondary|Number of Participants Within Each Category of Patient Satisfaction Score|Participants were interviewed at baseline and at the end of the trial (Week 26) to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.N (number of participants analyzed) signifies participants evaluable for this measure and n signifies those participants who were evaluated for this measure at specified time point."|||participants|||Number
2651335|NCT01662648|Secondary|Change From Baseline in Daytime Drowsiness at Week 26|"Daytime Drowsiness was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how often they have felt drowsy within the previous 7 days (from 0: not at all to 100:all the time). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone."|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points."|||millimeter (mm)||Standard Deviation|Mean
2651336|NCT01662648|Secondary|Change From Baseline in Sleep Quality at Week 26|"Sleep quality was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how well they have slept in the previous 7 days (from 0: very badly to 100: very well). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone."|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points."|||millimeter (mm)||Standard Deviation|Mean
2651337|NCT01662648|Secondary|Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26|The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points."|||units on a scale||Standard Deviation|Mean
2659946|NCT01585441|Secondary|Change in Serum Testosterone Concentration at the Safety Visit Compared to Baseline|The mean change is reported in nanograms of testosterone per decaliter of serum.|Final Study Visit||||ng/dL|Participants|Standard Deviation|Mean
2651338|NCT01662648|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26|"The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 indicates to normal, not at all ill and a rating of 7 indicates among the most extremely ill participants. Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone."|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."|||units on a scale||Standard Deviation|Mean
2651339|NCT01662648|Secondary|Change From Baseline in PANSS Total Negative Subscale Score at Week 26|The Negative Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."|||units on a scale||Standard Deviation|Mean
2651340|NCT01662648|Secondary|Change From Baseline in PANSS Total Positive Subscale Score at Week 26|The Positive Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess of or distortion of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."|||units on a scale||Standard Deviation|Mean
2651341|NCT01662648|Secondary|Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Percentage of participants with greater than or equal to 20 % improvement in PANSS total score is reported here. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Week 26|"ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."|||percentage of participants|||Number
2651342|NCT01662648|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.|Baseline and Week 26|"Intent to Treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. N (number of participants analyzed) signifies the participants evaluable for this measure."|||units on a scale||Standard Deviation|Mean
2651343|NCT01662635|Primary|FISH, IHC, RT-qPCR Comparison|200 samples underwent FISH, from them 63 underwent IHC and 48 RT-qPCR.|TWO YEARS|The only selection criteria of our subjets was the availability of tumor tissue to perform tests.|||participants|||Number
2651344|NCT01662583|Secondary|Number of Subjects Who Receive the 2nd Dose of the Influenza Vaccine on Time.||by 42 days after dose of first vaccination|One patient in the plain text message arm was removed for this analysis because they received the second dose too early and was not re-vaccinated|||percentage of participants|||Number
2651345|NCT01662583|Primary|Receipt of 2nd Dose of the Influenza Vaccine.||by April 30th after receipt of first dose (up to 8 months)||||percentage of participants|||Number
2651346|NCT01662531|Secondary|Consumption of rIX-FP During Routine Prophylaxis|Consumption of rIX-FP during routine prophylaxis is expressed as the total prophylaxis dose per month.|12 months|Efficacy Population|||IU/kg/month||Standard Deviation|Mean
2651347|NCT01662531|Secondary|Number of Bleeding Episodes Requiring One, Two or More Than Two Infusions of rIX-FP to Achieve Hemostasis|For each bleeding episode that required treatment, the number of episodes that required one, two or more than two infusions of rIX-FP to achieve hemostasis|Approximately 12 months|Efficacy Population|||bleeding episodes|||Number
2651348|NCT01662531|Secondary|Number of Subjects Developing Antibodies Against rIX-FP|Antibodies to rIX-FP were measured using a direct-binding enzyme-linked immunosorbent assay (ELISA).|12 months|Safety Population|||participants|||Number
2651349|NCT01662531|Secondary|Number of Subjects With Treatment-related Adverse Events||12 months|Safety Population|||participants|||Number
2651350|NCT01662531|Primary|Number of Subjects Developing Inhibitors to Factor IX (FIX)|Inhibitor formation was defined as any inhibitor (≥0.6 BU [Bethesda Units]/mL) identified and confirmed by retesting.|12 months|Safety Population|||participants|||Number
2651351|NCT01662531|Primary|Clearance for FIX Activity Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product|FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values. Clearance is normalized for body weight.|Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose|PK Population|||mL/hr/kg||Standard Deviation|Mean
2651352|NCT01662531|Primary|Area Under the Concentration Versus Time Curve From Time Point Zero to the Last Sample With Quantifiable Drug Concentration (AUClast)|"AUClast following a single intravenous dose of 50 IU/kg rIX-FP or previous FIX product.~FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values."|Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose|PK Population|||IU*hr/dL||Standard Deviation|Mean
2651353|NCT01662531|Primary|Half-life (t1/2) Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product|FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values.|Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose|PK Population|||hours||Standard Deviation|Mean
2651354|NCT01662531|Primary|Incremental Recovery Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product|Incremental recovery (IU/dL/IU/kg) is defined as the FIX activity (IU/dL) obtained 30 minutes following infusion, per dose of (IU/kg) infusion. FIX activity was measured at a central laboratory using validated one-stage clotting method. Recovery values were baseline-corrected for pre-infusion plasma FIX activity. Incremental recovery was measured following a single intravenous dose of 50 IU/kg rIX-FP on Day 1. Analysis of previous FIX product was conducted at the beginning of the study in a subset of subjects who had no historical pharmacokinetic (PK) data of their previous FIX product. For the PK assessment, the previous FIX product was administered by IV infusion after approximately 4 days following the last FIX treatment, prior to any dosing of rIX-FP. The formal PK population consisted of subjects who received at least 1 dose of rIX-FP for PK assessment and for whom a sufficient number of analyzable PK samples had been obtained to permit the evaluation of the PK profile of rIX-FP.|30 minutes after infusion|PK Population|||(IU/dL)/(IU/kg)||Standard Deviation|Mean
2651355|NCT01662505|Secondary|Remission Duration|The remission duration is the time from the date of achieving CR or CRi until relapse for patients with documented CR or CRi.|From first administration of trial drug up to 486 days|Treated Set, patient with remissions|||Days||Standard Deviation|Mean
2651356|NCT01662505|Secondary|Best Response by PR|"The secondary outcome best response will be presented by the CR, CRi and PR. In this outcome measure the PR is presented.~The criteria for the PR are:~All haematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%."|From first administration of trial drug up to 486 days|Treated Set|||Participants|||Number
2651357|NCT01662505|Secondary|Best Response by CRi|"The secondary outcome best response will be presented by the CR, CRi and PR. In this outcome measure the CRi will be presented.~The criteria for the CRi are:~All CR criteria are met except for residual neutropenia (<1.0 × 10^9/L [1000/μL]) or thrombocytopenia (<100 × 10^9/L [100 000/μL])."|From first administration of trial drug up to 486 days|Treated Set|||Participants|||Number
2651358|NCT01662505|Primary|MTD of Volasertib|Primary objective for this trial was to identify the MTD of volasertib. The MTD was defined as the highest dose level at which DLTs were reported in at most 2 in 6 evaluable patients during cycle 1. In this outcome measure the MTD is presented.|From first administration of trial drug up to 28 days|Treated Set|||milligram (mg)|||Number
2651359|NCT01662505|Secondary|Best Response by Complete Remission (CR)|"The secondary outcome best response will be presented by the CR, CR with incomplete blood count recovery (CRi) and partial remission (PR).~In this outcome measure the CR will be presented.~The criteria for the CR are:~Bone marrow blasts less than 5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) >1.0 × 10^9/Litre (L) (1000/microlitre (μL)); platelet count >100 × 10^9/L (100 000/μL); independence of red cell transfusions."|From first administration of trial drug up to 486 days|Treated Set|||Participants|||Number
2651360|NCT01662505|Primary|Number of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib|Primary objective for this trial was to identify the MTD of volasertib. The MTD was defined as the highest dose level at which DLTs were reported in at most 2 in 6 evaluable patients during cycle 1. In this outcome measure the number of participants with DLTs in cycle 1 is presented.|From first administration of trial drug up to 28 days|Treated Set|||Participants|||Number
2651361|NCT01662492|Secondary|Percentage of Patients Who Are Prescribed Oral Rescue Migraine Prophylactic Treatment|Percentage of patients who are prescribed oral rescue migraine prophylactic treatment during the 28-day period ending with Week 12 in the Intent-to-Treat population.|12 Weeks|Intent-to-Treat (ITT) Population: All randomized subjects.|||Percentage of participants|||Number
2651362|NCT01662492|Secondary|Percentage of Patients With ≥ 50% Decrease From Baseline in the Frequency of Headache Days|Percentage of patients with ≥ 50% decrease from baseline in the frequency of headache days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. A responder for headache days was defined as a patient with a 50% decrease in change from baseline in the frequency of headache days.|Baseline, 12 Weeks|Intent-to-Treat (ITT) Population: All randomized subjects.|||Percentage of participants|||Number
2651363|NCT01662492|Secondary|Change From Baseline in the Total Cumulative Hours of Headache on Headache Days|Change From Baseline in the Total Cumulative Hours of Headache on Headache Days during the 28-day period ending with Week 12 in the Intent-to-Treat Population. Total cumulative hours is defined as the sum of total duration of headaches on headache days.|Baseline, 12 Weeks|Intent-to-Treat (ITT) Population: All randomized subjects.|||Cumulative hours of headache||Standard Deviation|Mean
2651364|NCT01662492|Secondary|Change From Baseline in the Frequency of Severe Headache Days|Change from baseline in the frequency of severe headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A severe headache day is defined as a calendar day with 1 or more total hours of headache and with maximum severity reported as 'severe' for the day as recorded by the patient in the electronic diary.|Baseline, 12 Weeks|Intent-to-Treat (ITT) Population: All randomized subjects.|||Severe Headache Days||Standard Deviation|Mean
2651365|NCT01662492|Primary|Change From Baseline in the Frequency of Headache Days|Change from baseline in the frequency of headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A headache day for a patient is defined as a calendar day with 1 or more total hours of headache as recorded by the patient in the electronic diary.|Baseline, 12 Weeks|Intent-to-Treat (ITT) Population: All randomized subjects.|||Headache days||Standard Deviation|Mean
2651366|NCT01662440|Secondary|Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57|Safety was assessed as the number of subjects who reported unsolicited AEs after any vaccination given according to accelerated and conventional schedule.|Day 1 through Day 57|Analysis was done on the unsolicited safety set, ie, the subjects in the exposed population who provided postvaccination unsolicited safety data.|||Number of subjects|||Number
2651367|NCT01662440|Secondary|Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination|Safety was assessed as the number of subjects who reported solicited systemic AEs and other indicators of reactogenicity after each vaccination given according to accelerated and conventional schedule.|Day 1 through day 7 after each vaccination (day 1, 4, 8 and 29)|Analysis was done on the solicited safety set.|||Number of Subjects|||Number
2651368|NCT01662440|Secondary|Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection|Safety was assessed as the number of subjects who reported solicited local AEs after each placebo injection given according to accelerated and conventional schedule as follow: from day 1 through day 7 (injection on day 1; R - Conv and JE - Conv groups), day 4 through day 10 (injection on day 4; in R/JE - Conv, R - Conv and JE - Conv groups), day 8 through day 14 (injection on day 8; in R/JE - Conv, R - Conv and JE - Conv groups), and day 29 through day 35 (injection on day 29; R/JE - Acc, R - Con and JE - Conv groups).|Day 1 through day 7 after each injection (day 1, 4, 8 and 29)|Analysis was done on the solicited safety set.|||Number of Subjects|||Number
2651369|NCT01662440|Secondary|Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination|Safety was assessed as the number of subjects who reported solicited local AEs after each JE vaccination given according to accelerated or conventional schedule as follow: from day 1 through day 7 (vaccination on day 1; all JE groups), day 8 through day 14 (vaccination on day 8; R/JE - Acc group only), or day 29 through day 35 (vaccination on day 29; R/JE - Con and JE - Conv groups).|Day 1 through day 7 after each vaccination (on day 1, 8 and 29)|Analysis was done on the solicited safety set.|||Number of subjects|||Number
2651370|NCT01662440|Secondary|Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination|Safety was assessed as the number of subjects who reported solicited local adverse events (AEs) after each rabies vaccination given according to accelerated or conventional schedule as follows: from day 1 through day 7 (vaccination on day 1; all Rabies groups), day 4 through day 10 (vaccination on day 4; in R/JE - Acc group only), day 8 through day 14 (vaccination on day 8; all Rabies groups), or day 29 through day 35 (vaccination on day 29; R/JE - Conv and R - Conv groups).|Day 1 through day 7 after each vaccination (on day 1, 4, 8 and 29)|Analysis was done on the solicited safety set, i.e. the subjects in the exposed population who provided postvaccination solicited safety data.|||Number of subjects|||Number
2651371|NCT01662440|Secondary|Kinetics of JE Immune Response Measured as PRNT50 GMTs|To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the PRNT50 GMTs on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).|Day 1, 15, 22, 36, 57, 91, 181, and 366 (accelerated schedule) and day 1, 36, 57, 181, and 366 (conventional schedule)|Analysis was done on the PP dataset.|||Titers||95% Confidence Interval|Geometric Mean
2651372|NCT01662440|Secondary|Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10|To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the percentage of subjects with PRNT50 titer ≥1:10 on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).|Days 1, 15, 22, 36, 57, 91, 181 and 366|Analysis was done on the PP dataset.|||Percentages of subjects||95% Confidence Interval|Number
2651373|NCT01662440|Secondary|Kinetics of Rabies Immune Response Measured as the RVNA GMCs|To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the RVNA GMCs on days 1, 8, 15, 36, 57, 91, 181, and 366.|Day 1, 8, 15, 36, 57, 91, 181, and 366|Analysis was done on the PP dataset.|||IU/mL||95% Confidence Interval|Geometric Mean
2651374|NCT01662440|Secondary|Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL|To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the percentage of subjects with RVNA concentrations ≥0.5 IU/mL on days 1, 8, 15, 36, 57, 91, 181, and 366.|Day 1, 8, 15, 36, 57, 91, 181 and Day 366|Analysis was done on the PP dataset.|||Percentages of subjects||95% Confidence Interval|Number
2651375|NCT01662440|Secondary|Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination|"Immune response was measured as the percentage of subjects with PRNT50 titer of ≥1:10 7 days after last active vaccination, ie, day 15 for the group that received the accelerated schedule and day 36 for the group that received the conventional schedule.~As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv."|Day 15 and day 36 (28 after last active vaccination)|Analysis was done on the PP dataset.|||Percentages of subjects||95% Confidence Interval|Number
2651376|NCT01662440|Secondary|Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination|"Immune response was measured as the percentages of subjects with RVNA concentration ≥0.5 IU/mL 28 days after last active vaccination, ie, day 36 for the group that received the accelerated schedule and day 57 for the group that received the conventional schedule.~As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv."|Day 36 and day 57 (28 days after last active vaccination)|Analysis was done on the PP set.|||Percentages of subjects||95% Confidence Interval|Number
2651377|NCT01662440|Secondary|PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination|"Immune response was measured as the PRNT50 GMTs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.~Data were adjusted using ANOVA model, as per protocol specifications."|Day 57 (28 days after last active vaccination)|Analysis was done on the PP dataset.|||Titers||95% Confidence Interval|Geometric Mean
2651378|NCT01662440|Secondary|RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination|"Immune response was measured as the RVNA GMCs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.~Data were adjusted using ANOVA model, as per protocol specification."|Day 57 (28 days after last active vaccination)|Analysis was done on the PP dataset.|||IU/mL||95% Confidence Interval|Geometric Mean
2651379|NCT01662440|Primary|Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination|"Immune response was measured as the percentages of subjects with a titer of ≥1:10 in a 50% plaque reduction neutralization test (PRNT50) 28 days after last active vaccination, ie, the second out of three vaccinations given in the accelerated JE vaccine schedule and the third out of three vaccinations given in the conventional JE vaccine schedule.~As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv."|Day 28 after last active vaccination (day 36 - group that received accelerated schedule, day 57 - group that received conventional schedule)|Analysis was done on the PP dataset.|||Percentages of subjects||95% Confidence Interval|Number
2651380|NCT01662440|Primary|Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination|"Immune response was measured as the percentage of subjects with rabies virus neutralizing antibody (RVNA) concentrations ≥0.5 IU/mL, evaluated using the rapid fluorescent focus inhibition test at day 7 after last active vaccination, i.e. the third out of four vaccinations given in the accelerated Rabies vaccine schedule and the fourth out of four vaccinations given in the conventional Rabies vaccine schedule.~As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv."|Day 7 after last active vaccination (day 15 - group that received accelerated schedule, day 36 - group that received conventional schedule)|Analysis was done on the per-protocol (PP) dataset, ie, the subjects who received the vaccine correctly, provided evaluable serum samples at the relevant time points, and had no major protocol violations as defined prior to unblinding.|||Percentages of subjects||95% Confidence Interval|Number
2651381|NCT01662362|Secondary|ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas||Up to six months||||percentage of specimens ESA negative||95% Confidence Interval|Number
2651382|NCT01662362|Primary|ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas||Up to six months||||percent agreement to RIPA||95% Confidence Interval|Number
2651383|NCT01662336|Secondary|Healthcare Provider Satisfaction|For each participant, healthcare provider (HCP) satisfaction with the KASA program was measured by three questions assessing 1) the overall satisfaction with the KASA program, 2) subjective assessment on whether the KASA program was beneficial in maintaining adherence with HIV treatments, and 3) the likelihood of recommending KASA in the future. The scores for each question ranged from 0 to 100, with higher scores indicating higher satisfaction.|Month 6 and Month 12|Intent-to-treat population with non-missing data at each time point|||units on a scale||Standard Deviation|Mean
2651384|NCT01662336|Secondary|Cluster of Differentiation 4 (CD4) Positive Cell Counts at Each Visit||Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at each time point|||cells/mm³||Standard Deviation|Mean
2651385|NCT01662336|Secondary|Viral Load at Each Visit||Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point|||copies/mL||Standard Deviation|Mean
2651386|NCT01662336|Secondary|Health Resource Utilization|Health resource utilization (HRU) was measured by a self-administered questionnaire that contained a series of questions aimed at measuring the patient's utilization of healthcare resources and economic impact of the disease.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at each time point.|||percentage of participants|||Number
2651387|NCT01662336|Secondary|Change From Baseline in Coping Self-Efficacy|Change in coping self-efficacy was measured by the Coping Self-Efficacy Scale (CSE), a 26-item questionnaire that measures perceived self-efficacy in coping with daily psychological challenges. A summative score ranging from 0 to 260 was calculated, with higher scores indicating higher coping self-efficacy.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
2651388|NCT01662336|Secondary|Change From Baseline in Psychological Well-being|Change in psychological well-being was measured by the Center for Epidemiologic Studies Depression scale (CES-D), a 20-item questionnaire assessing the presence of depressive state during the previous week. The possible range of scores is 0 to 60, with higher scores indicating the presence of more symptomatology.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
2651389|NCT01662336|Secondary|Change From Baseline in Patient Perception of Stress|Change in perception of stress was measured by the Perceived Stress Scale (PSS), a 10-item questionnaire that assesses the degree to which the participant considered situations as stressful. The PSS score ranges from 0 to 40, with higher scores indicating higher levels of perceived stress.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
2651390|NCT01662336|Secondary|Change From Baseline in Health-related Quality of Life Energy/ Fatigue Domain Score|Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
2651391|NCT01662336|Secondary|Change From Baseline in Health-related Quality of Life Mental Health Domain Score|Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
2651802|NCT01658514|Primary|Cmax of Plasma Metformin|Cmax = Maximum concentration from the time of dosing (0 h) to the time of the last quantifiable metformin concentration following dose administration|from the time of dosing (0 h) to 72 hours postdose|PK Evaluable Population|||ng/mL||Standard Error|Least Squares Mean
2651392|NCT01662336|Secondary|Change From Baseline in Health-related Quality of Life Pain Domain Score|Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
2651393|NCT01662336|Secondary|Change From Baseline in Health-related Quality of Life Cognitive Functioning Domain Score|Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
2651394|NCT01662336|Secondary|Change From Baseline in Health-related Quality of Life Social Functioning Domain Score|Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
2651395|NCT01662336|Secondary|Change From Baseline in Health-related Quality of Life Role Functioning Domain Score|Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
2651396|NCT01662336|Secondary|Change From Baseline in Health-related Quality of Life Physical Functioning Domain Score|Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
2651397|NCT01662336|Secondary|Change From Baseline in Health-related Quality of Life General Health Perception Domain Score|Participant quality of life (QoL) was measured by the QoL 601-2 survey, the Health Status Assessment (HSA). This survey is a brief, comprehensive measure of health-related QoL used extensively in patients with human immunodeficiency virus / acquired immune deficiency syndrome (HIV/AIDS). The instrument includes 21 items assessing 8 domains of health-related quality of life including physical functioning, role functioning, social functioning, cognitive functioning, pain, energy / fatigue, mental health, and general health perception. Each domain score ranges from 0 to 100 with higher scores indicating higher quality of life.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point.|||units on a scale||Standard Deviation|Mean
2651398|NCT01662336|Secondary|Percentage of Participants Adherent to Treatment at Month 12|Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 12 was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.|Baseline and 12 months|The intent-to treat population; participants with missing information on the absolute change in the ASES summative score who were not discontinued from the study or lost to follow-up were excluded.|||percentage of participants||95% Confidence Interval|Number
2651399|NCT01662336|Secondary|Change From Baseline in Adherence Perseverance Subscale Score at Months 6 and 12|Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence perseverance subscale score ranges from 0 to 30, with higher scores indicating higher treatment self-efficacy.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point|||units on a scale||Standard Deviation|Mean
2651435|NCT01662102|Secondary|Overall Response Rate (ORR)|Tumor response will be evaluated according to Cheson criteria at the time of randomization and at the end of the 2-year maintenance/observation, post randomization. ORR is defined as the proportion of patients with a CR or a PR, and will be compared between treatment groups. Patients with no response evaluation (for any reason) will be considered as not evaluable (NE).|Up to 7 years|||||||
2651400|NCT01662336|Secondary|Change From Baseline in Adherence Integration Subscale Score at Months 6 and 12|"Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the patient's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do).~The 12 items converge to two subscales measuring adherence integration and adherence perseverance. The adherence integration subscale score ranges from 0 to 90, with higher scores indicating higher treatment self-efficacy."|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point|||units on a scale||Standard Deviation|Mean
2651401|NCT01662336|Secondary|Change From Baseline in Adherence Summative Score at Months 6 and 12|Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12-item tool that measures the participant's confidence to undertake treatment-related activities and behaviors including medication regimen, diet and exercise. Each question was answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy.|Baseline, Month 6 and Month 12|Intent-to-treat population with non-missing data at baseline and each time point|||units on a scale||Standard Deviation|Mean
2651402|NCT01662336|Primary|Percentage of Participants Adherent to Treatment at Month 6|Adherence was assessed by the Adherence Self-Efficacy Scale (ASES). The ASES is a 12 item tool that measures the patient's confidence to undertake treatment related activities and behaviors including medication regimen, diet and exercise. Each question is answered on a scale from 0 (cannot do at all) to 10 (certain can do). A summative score ranging from 0 to 120 was calculated, with higher scores indicating higher treatment self-efficacy. A participant was considered to have maintained adherence if the change in the ASES summative score at month 6 relative to Baseline was greater than or equal to zero. Participants who discontinued from the study or were lost to follow-up were considered non-adherent.|Baseline and 6 months|The intent-to treat population included all enrolled participants who received at least 1 dose of lopinavir/ritonavir; participants with missing information on the absolute change in the ASES summative score who were not discontinued from the study or lost to follow-up were excluded.|||percentage of participants||95% Confidence Interval|Number
2651403|NCT01662310|Secondary|Open-label Extension (OLE) Phase: Change From OLE Baseline in Personal and Social Performance (PSP) Scale Total Score at OLE Endpoint|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).|OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)|"The ITT OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
2651404|NCT01662310|Secondary|Open-label Extension (OLE) Phase: Change From OLE Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at OLE Endpoint|CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).|OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)|"The ITT OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
2651405|NCT01662310|Secondary|Open-label Extension (OLE) Phase: Change From OLE Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at OLE Endpoint|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).|OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)|"The Intent-to-Treat (ITT) OLE analysis set included all participants who received at least one dose of OLE medication as recorded on the electronic case report form (eCRF). LOCF method was used to impute missing values. N (number of participants analyzed) signifies the participants evaluable for this measure."|||Units on a scale||Standard Deviation|Mean
2651406|NCT01662310|Secondary|Double Blind (DB) Phase: Median Time to Relapse (Final Analysis)|A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed final analysis at the end of double-blind treatment (09 November 2012).|DB Baseline (Day 1 of Week 15) up to study completion (09 November 2012) (Approximately 1 year)|The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication up to final analysis cut-off date (09-Nov-2012).|||Days||95% Confidence Interval|Median
2651407|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at DB Endpoint|"Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: very badly to 100: very well). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15)."|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|"The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. n signifies those participants who were evaluated for this measure at the specified time point."|||Millimeter (mm)||Standard Deviation|Mean
2651408|NCT01662310|Secondary|Run-In and Stabilization Phase: Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at Week 14|"Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: very badly to 100: very well)."|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values."|||Millimeter (mm)||Standard Deviation|Mean
2651409|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at DB Endpoint|"Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: very badly to 100: very well). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15)."|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|"The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. n signifies those participants who were evaluated for this measure at the specified time point."|||Millimeter (mm)||Standard Deviation|Mean
2651410|NCT01662310|Secondary|Run-In and Stabilization Phase: Change From Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at Week 14|"Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: very badly to 100: very well)."|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values."|||Millimeter (mm)||Standard Deviation|Mean
2651411|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Personal and Social Performance (PSP) Scale Total Score at DB Endpoint|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication.|||Units on a scale||Standard Deviation|Mean
2651412|NCT01662310|Secondary|Run-In and Stabilization Phase: Change From Baseline in Personal and Social Performance (PSP) Scale Total Score at Week 14|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point. LOCF method was used to impute missing values."|||Units on a scale||Standard Deviation|Mean
2651413|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at DB Endpoint|CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication.|||Units on a scale||Standard Deviation|Mean
2651414|NCT01662310|Secondary|Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)|The CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point."|||Participants|||Number
2651415|NCT01662310|Secondary|Double Blind (DB) Phase: Change From DB Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at DB Endpoint|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).|DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])|The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication. LOCF method was used to impute missing values.|||Units on a scale||Standard Deviation|Mean
2651416|NCT01662310|Secondary|Run-In and Stabilization Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 14|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.|Baseline and Week 14|"The Intent-to-Treat (RI/ST) analysis set included all the participants who received at least one dose of study medication in run-in phase or stabilization phase. n signifies those participants who were evaluated for this measure at the specified time point. Last observation carried forward (LOCF) method was used to impute missing values."|||Units on a scale||Standard Deviation|Mean
2651417|NCT01662310|Primary|Double Blind (DB) Phase: Median Time to Relapse|A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed ongoing safety monitoring during double-blind treatment and conducted the interim analysis after 61 relapse events had taken place.|DB Baseline (Day 1 of Week 15) up to interim analysis data cut-off (24 August 2012) (Approximately 1 year)|"The Intent-to-Treat DB analysis set included all the participants who were randomized into the DB phase and who received at least one dose of DB study medication up to interim analysis cut-off date (24-Aug-2012). N (number of participants analyzed) signifies the participants evaluable for this measure."|||Days||95% Confidence Interval|Median
2651418|NCT01662297|Secondary|Medical Outcomes Study Sleep Scale- Sleep Index (Short)|THE RANGE OF SCORES IS FROM 0-100, WITH 100 REPRESENTING SEVERE INSOMNIA SYMPTOMS. Measurements made and reported at baseline, week 2, week 4. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. . This is a comparison between groups (trazodone versus quetiapine)of the change on TOTAL MOS-SS scores over time using repeated measures analysis. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8).|from baseline (week 0) to the end of week 8 sample|We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.|||units on a scale||Standard Deviation|Mean
2651419|NCT01662297|Secondary|Percentage of Negative Urine Drug Screens|This is a comparison between groups of the mean percent of negative urine drug screens. The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8). THIS IS A CUMULATIVE PERCENTAGE. MAXIMUM SCORE IS 100%, MINIMUM 0%.|from week 0 (baseline) to end of week 8|We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.|||percentage of tests||Standard Deviation|Mean
2651420|NCT01662297|Secondary|Percentage of Heavy Drinking Days|This is a comparison between groups of the mean percent heavy drinking days during the first 4 weeks, and then through to the follow up point (end of week 8). The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8).|from week 0 (baseline) to end of week 8|We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.|||percentage of heavy drinking days||Standard Deviation|Mean
2651421|NCT01662297|Secondary|Change in Alcohol Urge Questionnaire (AUQ)Scores Over Time|The lowest possible score for the AUQ is 8 (representing less urge to drink) and the highest score would be a 56 (more urge to drink). Measurements made at baseline, week 2, week 4, week 8. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. This is a comparison between groups (trazodone versus quetiapine)of the change on AUQ scores over time. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8).|from week 0 (baseline) to end of week 8|We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.|||units on a scale||Standard Deviation|Mean
2651436|NCT01662102|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to death from any cause. In living patients, survival time will be censored on the last date patients were known to be alive.|Up to 7 years|||||||
2651437|NCT01662102|Secondary|Time to Next Chemotherapy (TTNCT)|TTNCT is defined as the time from randomization to the first introduction of any new chemotherapy (cytotoxic or radioimmunotherapy). The TTNCT may be the same as the TTNLT. Patients who respond to treatment and patients who are lost to follow-up will be censored at the visit on which the dosing of a new medication was evaluated.|Up to 7 years|||||||
2651422|NCT01662297|Secondary|Change in Brief Symptom Inventory (BSI) Over Time|The Brief Symptom Inventory scale measures a broad range of psychiatric symptoms (psychological distress) and is meant to provide an overall measure of mental health symptomatology. The BSI has 53 items that use a 5-item Likert scale response. In general, higher scores correspond to greater symptomatology and distress. Usually, the range of scores goes from 0 - 4, since it is averaged over the number of responses, however, we report the raw total score which is the sum of all responses, thus the range is 0-212. Measurements made at baseline, week 2, week 4, week 8. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. This is a comparison between groups of the change on BSI scores over time using repeated measures analysis. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments.|from week 0 (baseline) to end of week 8|We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.|||units on a scale||Standard Deviation|Mean
2651423|NCT01662297|Secondary|Change in RAND Short Form 36 Item Health Survey (RAND-SF36) General Health Subscale Over Time|Scores range from 0-100 representing percentage, with a higher score representing better functioning. Measurements made at baseline, week 2, week 4, week 8. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. The change from week 4 to week 8 (post-intervention) will also be measured and analyzed, reported. This is a comparison between groups (trazodone versus quetiapine)of the change on RAND-SF36 scores over time. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8).|from week 0 (baseline) to end of week 8|We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.|||percentage of total points possible||Standard Deviation|Mean
2651424|NCT01662297|Secondary|Change in Epworth Sleepiness Scale (ESS) Over Time|Measurements made at baseline, week 2, week 4, week 8. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. The change from week 4 to week 8 (post-intervention) will also be measured and analyzed, reported. This is a comparison between groups (trazodone versus quetiapine)of the change on ESS scores over time using repeated measures analysis. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8).The minimum score on ESS is 0-24 units, with higher score representing greater sleepiness.|From baseline (week 0) to end of week 8|We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.|||units on a scale||Standard Deviation|Mean
2651425|NCT01662297|Secondary|Change in Insomnia Severity Index (ISI) Scores|THE RANGE OF SCORES IS FROM 0-28, WITH 28 REPRESENTING SEVERE INSOMNIA SYMPTOMS. Measurements made and reported at baseline, week 2, week 4. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. . This is a comparison between groups (trazodone versus quetiapine)of the change on TOTAL ISI scores over time using repeated measures analysis. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8).|from baseline (week 0) to the end of week 4 and at week 8|We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.|||units on a scale||Standard Deviation|Mean
2651426|NCT01662297|Primary|Change in Average Pittsburgh Sleep Quality Inventory (PSQI)Score|Data analyzed for change from score at baseline, to week 4, to week 8. The range of scores is 0-21 on this scale, with higher scores indicating worse sleep quality. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. This is a comparison between groups (trazodone versus quetiapine)of the change on TOTAL PSQI scores over time using repeated measures analysis. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. The first four weeks of treatment is the active acute experiment phase, and this will be the main comparison time period for the endpoint, but the investigators will also analyze change in PSQI until the follow-up point at the end of week 8.|From baseline (week 0) to end of 4 week and end of week 8|We had difficulty recruiting and retaining subjects for this study. 3 subjects were randomized and only 1 provided data beyond baseline.|||units on a scale||Standard Deviation|Mean
2651427|NCT01662115|Secondary|Use of NG Tubes|Nasogastric tube (re)insertions|30 days||||NG Tubes use||Full Range|Mean
2651428|NCT01662115|Secondary|Post-operative Vomiting|Episodes of vomiting|30 days||||vomiting episodes||Full Range|Mean
2651429|NCT01662115|Secondary|Hospital Stay|Length of postoperative hospital stay|30 days||||days||Full Range|Mean
2651430|NCT01662115|Primary|Bowel Function Recovery|Time to first bowel movement or flatus|7 days||||days||Full Range|Mean
2651431|NCT01662102|Primary|Progression Free Survival|Statistical Analysis of primary outcome measure data was not performed due to only one patient being enrolled in this study.|24 months|Statistical Analysis of primary outcome measure data was not performed due to only one patient being enrolled in this study.||||||
2651432|NCT01662102|Secondary|Pharmacoeconomics (Cost Effectiveness Analysis)|A cost-effectiveness analysis will be done that compares the efficiency (cost/effectiveness unit) of consolidation treatment with 90Y-ibritumomab tiuxetan compared to maintenance treatment with rituximab. The analysis will be conducted according to a health economic analysis plan independent from this clinical study protocol.|Up to 24 months|||||||
2651433|NCT01662102|Secondary|Quality of Life (QoL)|QoL will be assessed through EORTC FACT-G and QLQ-[C]30 questionnaires, and will be compared at each specified time point between treatment arms.|Up to 7 years|||||||
2651434|NCT01662102|Secondary|Transformation at First Progression|Transformation rate at first progression, defined as the appearance of diffuse areas of large lymphoma cells within a tumor site.|Up to 7 years|||||||
2651442|NCT01662063|Secondary|Percentage of Participants With Remission According to DAS28, SDAI, and Boolean Criteria|Remission was defined as DAS28 <2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for remission was calculated at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||percentage of participants|||Number
2651443|NCT01662063|Secondary|Number of Participants With Remission According to DAS28, SDAI, and Boolean Criteria|Remission was defined as DAS28 <2.6, SDAI ≤3.3, or meeting all Boolean criteria (28-count SJC and TJC ≤1, VAS ≤10 mm, and hsCRP ≤1 mg/dL). For DAS28 and SDAI formulas, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. For these instruments, higher scores indicate increased disease activity. The number of participants who met criteria for remission was reported at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||participants|||Number
2651444|NCT01662063|Secondary|Percentage of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria|Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The percentage of participants who met criteria for low disease activity was calculated at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.|||percentage of participants|||Number
2651445|NCT01662063|Secondary|Number of Participants With Low Disease Activity According to DAS28, SDAI, and CDAI Criteria|Low disease activity was defined as DAS28 ≤3.2, SDAI ≤11, or CDAI ≤10. For each formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS), with potential scores from 0 to 10. The SDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician) + hsCRP, with potential scores from 0 to infinity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The CDAI was calculated as SJC + TJC + VAS (participant) + VAS (physician), with potential scores from 0 to 76. For all instruments, higher scores indicate increased disease activity. The number of participants who met criteria for low disease activity was reported at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.|||participants|||Number
2651446|NCT01662063|Secondary|Percentage of Participants With HAQ-DI Score <0.5|The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The percentage of participants achieving a score <0.5 was calculated at each visit.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.|||percentage of participants|||Number
2651447|NCT01662063|Secondary|Change From Baseline in HAQ-DI Score|The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability. The change from Baseline to each visit was calculated, where positive changes represent an increased need for assistance with daily activities.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
2651448|NCT01662063|Secondary|Heath Assessment Questionnaire-Disability Index (HAQ-DI) Score|The Stanford HAQ-DI was calculated as the average of 20 questions, each scored from 0 (no difficulty) to 3 (unable to do). The questionnaire included 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Overall scores may range from 0 to 3, with higher scores representing increased disability.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.|||units on a scale||Standard Deviation|Mean
2651478|NCT01662063|Primary|Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Baseline|Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.|Baseline|Safety Population; only participants with a valid assay at Screening were included.|||percentage of participants|||Number
2659947|NCT01585441|Secondary|Change in Serum Testosterone Concentration at Month 3 Compared to Baseline|The mean change is reported in nanograms of testosterone per decaliter of serum.|Month 3||||ng/dL||Standard Deviation|Mean
2651449|NCT01662063|Secondary|Change From Baseline in Global Assessment of Pain by the Participant According to VAS Score|"The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no pain) to 100 mm (unbearable pain), with higher scores representing an increase in pain. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in pain."|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||mm||Standard Deviation|Mean
2651450|NCT01662063|Secondary|Global Assessment of Pain by the Participant According to VAS Score|"The Global Assessment of Pain was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no pain) to 100 mm (unbearable pain), with higher scores representing an increase in pain."|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.|||mm||Standard Deviation|Mean
2651451|NCT01662063|Secondary|Change From Baseline in Global Assessment of Disease Activity by the Participant According to VAS Score|"The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no disease activity) to 100 mm (maximum disease activity), with higher scores representing an increase in perceived symptoms. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in perceived disease activity."|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||mm||Standard Deviation|Mean
2651452|NCT01662063|Secondary|Global Assessment of Disease Activity by the Participant According to Visual Analog Scale (VAS) Score|"The Global Assessment of Disease Activity was performed using a 100-mm horizontal VAS. Scores may range from 0 mm (no disease activity) to 100 mm (maximum disease activity), with higher scores representing an increase in perceived symptoms."|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.|||mm||Standard Deviation|Mean
2651453|NCT01662063|Secondary|Time to Return to the QW Regimen After Switching to the Q2W Regimen|Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. Time to return was defined as the time between switching to the Q2W regimen and returning to the previous QW regimen.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants who switched from the QW to Q2W regimen and returned to the QW regimen were included.|||weeks||Full Range|Median
2651454|NCT01662063|Secondary|Number of Participants Who Returned to the QW Regimen After Switching to the Q2W Regimen|Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and thereafter returned to the QW regimen was reported with the reason for returning to the QW regimen.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants who switched from the QW to Q2W regimen were included.|||participants|||Number
2651455|NCT01662063|Secondary|Percentage of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen|Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The percentage of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was calculated.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population. The results were presented for all participants to account for multiple switches between arms (i.e., participants who started in the Q2W arm could have switched to QW and then switched back to Q2W, making them analyzable for the outcome measure).|||percentage of participants|||Number
2651456|NCT01662063|Secondary|Number of Participants Who Switched From the QW Regimen and Remained on the Q2W Regimen|Participants could switch between regimens at the Investigator's judgment based upon safety, efficacy, and pharmacokinetic/pharmacodynamic data. The number of participants who switched from the QW to the Q2W regimen and did not return to the QW regimen was reported.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population. The results were presented for all participants to account for multiple switches between arms (i.e., participants who started in the Q2W arm could have switched to QW and then switched back to Q2W, making them analyzable for the outcome measure).|||participants|||Number
2651457|NCT01662063|Secondary|Percentage of Reasons Given for CCS Discontinuation|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS discontinuation >14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a CCS discontinuation >14 days were included.|||percentage of reasons|Participants||Number
2651458|NCT01662063|Secondary|Percentage of Reasons Given for CCS Dose Interruption|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose interruption ≤14 days were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a CCS dose interruption ≤14 days were included. Results were only reported for the QW arm because no participants in the Q2W arm had a CCS dose interruption.|||percentage of reasons|Participants||Number
2651502|NCT01661790|Other Pre-specified|Quantitative RT-PCR(Reverse Transcription-Polymerase Chain Reaction) for VEGF-A(Vascular Endothelial Growth Factor A)||before intrapleural administration|||||||
2651503|NCT01661790|Secondary|Qualify of Life (QoL)||baseline to biweekly,until death|||||||
2651504|NCT01661790|Secondary|Adverse Reactions||Up to 1 month after the last treatment|||||||
2651459|NCT01662063|Secondary|Percentage of Reasons Given for CCS Dose Reduction|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ. The reasons for any CCS dose reduction were reported. More than one reason could be given for a single change in CCS therapy, and each participant could also change CCS therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a CCS dose reduction were included.|||percentage of reasons|Participants||Number
2651460|NCT01662063|Secondary|Percentage of Participants With a CCS Dose Reduction, Interruption, or Discontinuation|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants who received at least one CCS before the last dose of TCZ were included.|||percentage of participants|||Number
2651461|NCT01662063|Secondary|Number of Participants With a Corticosteroid (CCS) Dose Reduction, Interruption, or Discontinuation|Use of concomitant medications, including CCS treatment, was recorded throughout the study. Any change in CCS therapy was documented and reported among those participants who received at least one CCS before the last dose of SC TCZ.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants who received at least one CCS before the last dose of TCZ were included.|||participants|||Number
2651462|NCT01662063|Secondary|Percentage of Reasons Given for DMARD Discontinuation|Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD discontinuation were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a DMARD discontinuation >60 days were included.|||percentage of reasons|Participants||Number
2651463|NCT01662063|Secondary|Percentage of Reasons Given for DMARD Dose Reduction or Interruption|Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline. The reasons for any DMARD dose reduction/interruption ≤60 days were reported. More than one reason could be given for a single change in DMARD therapy, and each participant could also change DMARD therapy more than once. Therefore, the number of reasons could exceed the number of participants analyzed.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants with a DMARD dose reduction/interruption ≤60 days were included.|||percentage of reasons|Participants||Number
2651464|NCT01662063|Secondary|Percentage of Participants With a DMARD Dose Reduction, Interruption, or Discontinuation|Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants receiving at least one DMARD at Baseline were included.|||percentage of participants|||Number
2651465|NCT01662063|Secondary|Number of Participants With a Disease-Modifying Anti-Rheumatic Drug (DMARD) Dose Reduction, Interruption, or Discontinuation|Use of concomitant medications, including non-biologic DMARDs, was recorded throughout the study. Any change in DMARD therapy was documented and reported among those participants receiving at least one DMARD at Baseline.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|ITT Population; only participants receiving at least one DMARD at Baseline were included.|||participants|||Number
2651466|NCT01662063|Secondary|Change From Baseline in SJC Score|Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of swollen joints.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||swollen joints||Standard Deviation|Mean
2651467|NCT01662063|Secondary|Swollen Joint Count (SJC) Score|Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The number of swollen joints was taken as the SJC score, where values may range from 0 to 66.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.|||swollen joints||Standard Deviation|Mean
2651468|NCT01662063|Secondary|Change From Baseline in TJC Score|Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68. The change from Baseline to each visit was calculated, where positive changes represent an increase in number of tender joints.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||tender joints||Standard Deviation|Mean
2651469|NCT01662063|Secondary|Tender Joint Count (TJC) Score|Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The number of tender joints was taken as the TJC score, where values may range from 0 to 68.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.|||tender joints||Standard Deviation|Mean
2651505|NCT01661790|Secondary|Overall Survival (OS)||randomization to four weeks,until death|||||||
2651506|NCT01661790|Secondary|Median Progression Free Survival (PFS)||baseline to biweekly,until disease progression|||||||
2651470|NCT01662063|Secondary|Change From Baseline in SDAI Score|The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and hsCRP level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 mg/dL, scores would be expected to fall within ≤77 points. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
2651471|NCT01662063|Secondary|Simplified Disease Activity Index (SDAI) Score|The SDAI was calculated using the SJC, TJC, Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores, and high-sensitivity C-reactive protein (hsCRP) level. For the SDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The SDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician) + hsCRP. Because the formula includes hsCRP, scores may theoretically range from 0 to infinity, where higher scores indicate increased disease activity. However, based upon normal hsCRP level within 1 milligram per deciliter (mg/dL), scores would be expected to fall within less than or equal to (≤) 77 points.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
2651472|NCT01662063|Secondary|Change From Baseline in CDAI Score|The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
2651473|NCT01662063|Secondary|Clinical Disease Activity Index (CDAI) Score|The CDAI was calculated using the SJC, TJC, and Global Assessment of Disease Activity by the patient and by the physician according to separate VAS scores. For the CDAI formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The CDAI was calculated as the sum of the component scores, that is, SJC + TJC + VAS (participant) + VAS (physician). Scores may range from 0 to 76, where higher scores indicate increased disease activity.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|ITT Population; only those participants who provided evaluable data (n) were included in the analysis.|||units on a scale||Standard Deviation|Mean
2651474|NCT01662063|Secondary|Change From Baseline in DAS28 Score|The DAS28 was calculated using the SJC, TJC, ESR, and Global Assessment of Disease Activity by the participant according to VAS score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-mm scale to a 10-point score. The DAS28 was calculated as (0.56 × square root of TJC) + (0.28 × square root of SJC) + (0.7 × ln ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity. The change from Baseline to each visit was calculated, where positive changes represent an increase or worsening in disease activity.|Baseline to Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
2651475|NCT01662063|Secondary|Disease Activity Score Based on 28 Joints (DAS28) Score|The DAS28 was calculated using the Swollen Joint Count (SJC), Tender Joint Count (TJC), erythrocyte sedimentation rate (ESR), and Global Assessment of Disease Activity by the participant according to Visual Analog Scale (VAS) score. For the DAS28 formula, the SJC and TJC values were based upon 28 joints, and VAS was transformed from a 100-millimeter (mm) scale to a 10-point score. The DAS28 was calculated as (0.56 multiplied by [×] square root of TJC) + (0.28 × square root of SJC) + (0.7 × log natural [ln] ESR) + (0.014 × VAS). Scores may range from 0 to 10, where higher scores indicate increased disease activity.|Baseline and Weeks 12, 24, 36, 48, 60, 72, 84|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided data for the outcome measure. The number of participants who provided data for each analysis (n) is shown in the table."|||units on a scale||Standard Deviation|Mean
2651476|NCT01662063|Secondary|Percentage of Participants Who Correctly Administered All SC TCZ Doses|Compliance was assessed using drug dispensing logs, diary cards kept by the participant, and return records, as reviewed by the Investigator at regular visits. Total compliance up to the end of treatment was defined as the percentage of participants who correctly administered all scheduled doses of SC TCZ. Correct administration was defined as proper injection technique, injection of the correct amount (162 mg), device not left at room temperature for greater than (>) 8 hours, and absence of other medication errors.|From Baseline to last dose; assessed every 4 weeks during treatment (up to 96 weeks overall)|Intent-to-Treat (ITT) Population: All participants who received at least one dose of study medication and had at least one post-dose efficacy assessment.|||percentage of participants|||Number
2651477|NCT01662063|Primary|Percentage of Participants With a Positive Anti-TCZ Antibody Assay Post-Baseline|Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated. Positive assay results obtained post-Baseline were further investigated via confirmation assay and a neutralization assay.|From Week 12 up to 8 weeks after last dose; assessed at Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)|Safety Population; only participants with a valid assay at Screening were included.|||percentage of participants|||Number
2651479|NCT01662063|Primary|Percentage of Participants With a Positive Anti-TCZ Antibody Assay at Any Timepoint|Blood samples were collected to test for the presence of antibodies to TCZ. The percentage of participants with a positive anti-TCZ antibody assay was calculated.|From Baseline to 8 weeks after last dose; assessed at Baseline; Weeks 12, 24, 36, 48, 60, 72, 84, 96; and up to 8 weeks after last dose (up to 2 years overall)|Safety Population; only participants with a valid assay at Screening were included.|||percentage of participants|||Number
2651480|NCT01662063|Primary|Percentage of Participants With at Least One SAE|AEs were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The percentage of participants with at least one SAE regardless of treatment relationship was calculated.|From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)|Safety Population.|||percentage of participants|||Number
2651481|NCT01662063|Primary|Number of Participants With at Least One Serious Adverse Event (SAE)|Adverse events (AEs) were monitored throughout treatment. AEs were defined as any untoward medical occurrence in a participant who received study drug regardless of causality. SAEs were defined as AEs that were fatal or life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, manifested as a congenital anomaly/birth defect, were medically significant, or required intervention to prevent any of the aforementioned outcomes. The number of participants with at least one SAE regardless of treatment relationship was reported.|From Baseline to 8 weeks after last dose; assessed continuously during treatment (up to 96 weeks) and up to 8 weeks after last dose (up to 2 years overall)|Safety Population.|||participants|||Number
2651482|NCT01662024|Secondary|Waist Circumference Loss (cm)|Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Waist Circumference Loss (cm)|12 Months||||cm||Full Range|Mean
2651483|NCT01662024|Secondary|BMI Loss (kg/m^2)|Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: BMI Loss (kg/m^2)|12 Months||||kg/m^2||Full Range|Mean
2651484|NCT01662024|Secondary|Percentage of Total Body Weight Loss|Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percentage of Total body weight loss|12 Months||||Percentage of total weight lost||Full Range|Mean
2651485|NCT01662024|Secondary|Durability|Data will be collected on the durability of the plications by evaluating the remaining plications at the 12 month endoscopy, compared to the number of plications placed at the time of procedure.|12 months|Endoscopies were performed at 12 months but it was difficult to count the number of plications still intact as originally planned.||||||
2651486|NCT01662024|Secondary|Percent Excess Weight Loss|Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline: Percent excess weight loss|12 Months||||Percentage of excess weight lost||Full Range|Mean
2651487|NCT01662024|Primary|Evaluation of Technical Feasibility of the Procedure|Technical success was defined by placement of at least 8 running sutures and 4 interrupted sutures in the gastric body with exclusion of the lateral stomach.|Day 0 - Procedure Day||||Sutures||Full Range|Mean
2651488|NCT01662024|Primary|Number of Participants With Adverse Events|Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period. Postoperative adverse events were defined as occurring during the first three days after the procedure. Delayed adverse events were defined as occurring on the fourth post-procedure day or afterwards.|12 months||||Participants|||Count of Participants
2651489|NCT01661972|Secondary|Median Survival|Time in months from the start of study treatment to date of death due to any cause. Median survival was estimated using a Kaplan-Meier curve and is the time point at which 50% of patients remain alive.|Subjects will be followed until death which is estimated to be on average 6 months - 1 year after coming off protocol therapy|Patients enrolled in Phase 2 were included in the analysis|||months||95% Confidence Interval|Median
2651490|NCT01661972|Secondary|Response Rate|The percentage of patients for whom the best overall response is complete response (CR) or partial response (PR). A CR occurs when all lesions disappear; whereas, a PR is indicated when there is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesion. A PD (progressive disease) occurs when there is at least a 20% increase in the sum of the LD relative to the smallest sum LD recorded since treatment is initiated. Disease is considered stable if there is no response and no PD. All patients were assigned a best response for inclusion in this calculation in accordance with the protocol.|approximately every 9 weeks and/or restaging, through study completion|All evaluable Phase 2 patients. 5 patients were not evaluable for response and were not included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2651491|NCT01661972|Primary|Median Progression Free Survival (PFS)|Time in months from the start of study treatment to the date of first progression (PD) according to the RECIST criteria, or death due to any cause. Per RECIST criteria, a PD is indicated when there is at least a 20% increase in the sum of the longest diameters from target lesions relative to the smallest sum recorded since treatment is initiated. Median PFS was estimated using a Kaplan-Meier curve, and is the time at which 50% of patients remain alive without disease progression.|approximately 5 months|Patients enrolled in Phase 2 were included in the analysis|||Months||95% Confidence Interval|Median
2651507|NCT01661790|Primary|"Number of Participants With Complete Response and Partial Response"|Response assessed by type-B ultrasonic tests; Complete remission (CR) was considered when the accumulated fluid had disappeared and was stable for at least four weeks; partial remission (PR) was considered when >50% of the accumulated fluid had disappeared, symptoms had improved, and the remaining fluid had failed to increase for at least four weeks; The total efficiency ORR was calculated by taking the sum of CR+PR|from randomization, This treatment was given every two weeks,responses were made by biweekly||||participants|||Number
2651803|NCT01658514|Primary|AUC (0-t) of Plasma Metformin|AUC (0-t) = Area under the curve from the time of dosing (0 h) to the time of the last quantifiable concentration following dose administration|from the time of dosing (0 h) to 72 hours postdose|PK Evaluable Population|||ng*h/mL||Standard Error|Least Squares Mean
2651492|NCT01661972|Primary|Number of Dose-Limiting Toxicities (Phase 1)|"Number of patients experiencing a dose-limiting toxicity in each cohort.~A dose-limiting toxicity is defined as Grade 4 neutropenia, thrombocytopenia or anemia or grade 3 neutropenia or thrombocytopenia lasting over 7 days Grade 3 thrombocytopenia associated with bleeding Febrile Neutropenia Nausea/Vomiting or Diarrhea ≥ grade 3 and lasting ≥ 4 days despite adequate supportive measures Grade ≥ 3 Bilirubin, ALT or AST > 7 days Other non-hematologic toxicity ≥ grade 3 excluding alopecia, anorexia, fatigue, hypertension, isolated lab abnormalities (not clinically significant) and/ rare, idiosyncratic reactions to any of the study drugs. Anorexia, fatigue and hypertension will be considered as DLT only if they reach grade 4 or are considered unmanageable Treatment delay of ≥ 14 days for cycle 2 due to unresolved toxicity Treatment-related death or clinically significant,treatment-related hospitalization"|28 days||||Participants|||Count of Participants
2651493|NCT01661972|Primary|Recommended Phase II Dose (RPTD) for the Capecitabine and Aflibercept Doublet Combination|Phase 1 of this study will be the dose escalation component to determine safety and the Recommended Phase II dose (RPTD) for the capecitabine plus aflibercept combination. Cohort 1 will receive 850mg/m2 capecitabine and 6mg/kg aflibercept. If less than 2 of 6 patients experience a dose limiting toxicity in Cohort 1, then the next patients will be enrolled in Cohort 2 at 1000mg/m2 capecitabine and 6mg/kg aflibercept. RPTD is determined by the number of dose limiting toxicities (Primary obj 2 for Phase I).|RPTD for the study will be determined at the completion of Phase I; up to 1 year.||||mg/m2|||Number
2651494|NCT01661946|Primary|Maximum Concentration (Cmax) of Anti-VEGF Antibody|The serum concentrations of anti-VEGF antibody (bevacizumab or ranibizumab) will be measured pre-injection as well as at various time points after injection (1 day, 1 week, 2 weeks, 1 month). These time points are selected based on previously completed animal studies. The Cmax will be compared between bevacizumab and ranibizumab.|1 month||||ng/mL||Standard Error|Mean
2651495|NCT01661933|Secondary|Serum Anti-tissue Transglutaminase Antibodies Measured as International Units/mL (IU/mL)|The trial was extended with pre-trial and mid-trial anti-tTG antibody levels used to compare with the post-trial levels. Anti-tTG is a serological measure of tissue transglutaminase-2 antibodies. In active celiac disease, levels are increased. In treated disease, levels are low (normal cut-off was <15 IU/mL). A significant increase compared to baseline in tTG can be expected 2 weeks after consuming 3g of gluten daily for 2 weeks in people with celiac disease who have been maintaining a gluten-free diet, but who are not taking other treatment.|Anti-tTG IU/mL levels pre-trial, mid-trial and after 3 gram/day gluten challenge|2 of 12 participants did not progress past baseline micro-challenge, 2 of 10 participants did not progress past low-dose challenge.|||International Units/mL||95% Confidence Interval|Mean
2651496|NCT01661933|Secondary|Number of Participants With 2 Points Increase in Marsh Score Post GC-1g|The Marsh score is a defined but qualitative assessment assigned a value to allow for comparison. The scores were evaluated by consensus between the primary (chief) investigator and the study pathologist. The Marsh score was graded 0, 1, 2, 3A (assigned-4), 3B (-5) and 3C (-6); rage 1-6 with normal=0 and severe inflammation=6. Because the scoring is vulnerable to artefact, only a 2-point shift was regarded as a significant intra-individual change. The scores were graded after week-36 on biopsies de-identified shuffled. An upward shift was interpreted to reflect a significant worsening of gluten-associated inflammation. The comparison reported evaluated changes from baseline (week-24) to post-low-dose gluten challenge (week-24; GC-1g). The objective for using the Marsh score was to identify individuals who might have experienced a severe worsening in pathology due to GC-1g that might not be reflected in the Vh:Cd group analysis.|Longitudinal change between week-24 and week-36|The outcome score was the number with a 2-point increase in Marsh 3 score post GC-1g.|||participants|||Number
2651497|NCT01661933|Secondary|Intraepithelial Lymphocyte Count|Biopsies were fixed in neutral buffered formalin, processed and carefully orientated and embedded in paraffin wax. Sections (3 µm) were stained with anti-CD3. All slides were de-identified and graded by Dr John Croese. The IEL percentages were measured on 2 or more randomly selected well-orientated villi. The null hypothesis is that hookworm infection will not protect against mucosal IEL influx following 12-week exposure to gluten in celiac disease.|Week-24 and -36||||Percentage of epithelial cells||95% Confidence Interval|Mean
2651498|NCT01661933|Primary|Duodenal Villus Height:Crypt Depth|Biopsies were fixed in neutral buffered formalin, processed and carefully orientated and embedded in paraffin wax. Sections (3 µm) were stained with H&E. Slides from both time-points were de-identified, shuffled and graded by Dr John Croese after which results from poorly orientated slides were verified by Dr Andrew Clouston. The Vh:Cd ratios were measured on 5 randomly selected well-orientated sites. The null hypothesis is that hookworm infection will not protect against mucosal damage following 12-week exposure to gluten in celiac disease.|Week -24 to -36|All 10 of 12 participants who completed micro-challenge successfully progressed and completed low-dose challenge.|||Ratio||95% Confidence Interval|Mean
2651499|NCT01661881|Secondary|Autologous Stem Cell Transplant (ASCT) Rate|ASCT rate is the proportion of patients who completed therapy and proceeded to autologous stem cell transplant (ASCT)|All patients were followed for continuation to ASCT upon completion of induction therapy. Patients usually proceed to ASCT within 3 months of completing induction.||||proportion of participants||90% Confidence Interval|Number
2651500|NCT01661881|Secondary|1 Year Progression-Free Survival|1-year progression-free survival is the probability of patients remaining alive and progression-free at 1 year from study entry estimated using Kaplan-Meier methods. Disease progression was based on the International Working Group (IWG) Criteria (Cheson et al, 1999).|Disease was assessed after three- and six-cycles of therapy and in long-term follow-up per standard practice every 6 months until the earliest of relapse, death or 5 years. Median follow-up in this study cohort was 13 months.|The analysis dataset is comprised of all enrolled patients.|||probability||90% Confidence Interval|Number
2651501|NCT01661881|Primary|Complete Remission (CR) Rate After 6 Cycles|The CR rate is defined as the proportion of patients who after 6 cycles of therapy achieve complete remission based on the International Working Group (IWG) Criteria (Cheson et al, 1999), using CT scans. CR or CRu (CR unconfirmed) by CT scans was defined by standard IWG criteria, ie resolution of all abnormal adenopathy and organomegaly, and clearance of marrow disease when present at baseline.|Disease was assessed after three- and six-cycles of therapy, up to approximately 25 weeks. All patients completed 6 cycles of therapy with a cycle duration of 28 days.|The analysis dataset is comprised of all enrolled patients.|||proportion of participants||90% Confidence Interval|Number
2651508|NCT01661764|Other Pre-specified|Insulin Sensitivity|"homeostasis model assessment-insulin resistance (HOMA-IR) HOMA-IR. Fasting insulin and glucose were be used to determine HOMA-IR: [fasting glucose (mmol/l) x fasting insulin (µU/ml)]/22.5], Optimal insulin sensitivity: < 1, Early insulin resistance: > 1.9, Significant insulin resistance: > 2.9"|6 months||||HOMA-IR Index||Standard Deviation|Mean
2651509|NCT01661764|Other Pre-specified|Adipokines|leptin and adiponectin|6 months|Adipokines were not measured on all trial participants due to assay expense. Samples measurements were not completed on 3 GG, fish oil, 0 GG, placebo, 3 GT fish oil, 4 GT placebo, 7 TT fish oil, 9 TT placebo|||ng/mL||Standard Deviation|Mean
2651510|NCT01661764|Other Pre-specified|C-reactive Protein||6 months||||mg/L||Standard Deviation|Mean
2651511|NCT01661764|Secondary|Rectal Epithelial Cell Production of PGE2 and PGE3|liquid chromatography/tandem mass spectrometric on rectal biopsy samples|6 months|For some participants the volume of frozen tissue was not enough to measure rectal eicosanoids and are not included in the analysis (2 from GG, fish oil, 2 from GG, placebo, 3 from GT fish oil, 4 GT placebo, 1 TT fish oil and 3 TT placebo)|||ng/g||Standard Deviation|Mean
2651512|NCT01661764|Secondary|Rectal Epithelial Cell Phospholipid Fatty Acid Content|Lipids will be extracted using the method of Folch-Lees|6 months|Due to inadequate rectal tissue specimens we were unable to measure rectal tissue phospholipids||||||
2651513|NCT01661764|Secondary|Rectal Epithelial Cell 15-PGDH Expression|Expression of 15-PGDH in rectal epithelial cells will be detected following the standard IHC protocol of EnVision™+ System, HRP (DAKO).|6 months||||percentage of cells positive||Standard Deviation|Mean
2651514|NCT01661764|Secondary|Rectal Epithelial Cell COX-2 Expression|Expression of COX-2 in rectal epithelial cells will be detected following the standard IHC protocol of EnVision™+ System, HRP (DAKO).|6 months||||percentage of cells positive||Standard Deviation|Mean
2651515|NCT01661764|Primary|Rectal Epithelial Cell Apoptosis|The primary outcome of interest is rectal epithelial cell apoptosis as measured by TUNEL (TdT-mediated dUTP Nick-End Labeling). The TUNEL assay is conducted to measure apoptosis of colon epithelium using DeadEnd Colorimetric TUNEL System (Promega). After all fields of each sample are measured, the final immunoreaction indices are generated automatically by setting algorithms as ''total positive area / total nuclear area. Apoptotic activity is also scored using standard morphologic criteria applied to H&E stained sections.|6 months||||percentage of cells positive||Standard Deviation|Mean
2651516|NCT01661764|Primary|Rectal Epithelial Cell Proliferation|The primary outcome of interest is rectal epithelial cell proliferation, as measured by Ki67 (mib-1) labeling. Expression of Ki-67 in colon epithelial cells will be detected following the standard IHC protocol of EnVision™+ System, HRP (DAKO).|6 month|Patients with before and after rectal biopsies|||percentage of cells positive||Standard Deviation|Mean
2651517|NCT01661712|Secondary|Sleepiness|Daytime sleepiness as an ad-hoc measurement, as measured by the Stanford Sleepiness Scale (0-7 points, x). Higher values in the scale range represent more severe sleepiness.|1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)||||units on a scale||Inter-Quartile Range|Median
2651518|NCT01661712|Secondary|Device Acceptance|Device acceptance during sleep study, as measured by a visual analogue scale (0-10points). Higher values in the scale range represent a better outcome.|1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)||||units on a scale||Inter-Quartile Range|Median
2651519|NCT01661712|Secondary|Patient Comfort|Patient comfort during the sleep study, as measured by a visual analogue scale (0-10 points). Higher values in the scale range represent a better outcome.|1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)||||units on a scale||Inter-Quartile Range|Median
2651520|NCT01661712|Secondary|Nadir Oxygenation|The nadir oxygenation (lowest SpO2, %) during the sleep study is measured while the patients are asleep.|1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)||||% of haemoglobin that is oxygenated||Inter-Quartile Range|Median
2651521|NCT01661712|Secondary|Apnoea-Hypopnoea Index (AHI)|The Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. An apnea (pause in breathing) is defined by a temporary cessation of breathing that must last for at least 10 seconds and be associated with a decrease in blood oxygenation. A hypopnoea is a reduction of ventilation (shallow breathing) but not a complete cessation of breathing, lasting al least 10 seconds and associated with a decrease in blood oxygenation.|1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)||||events/hour||Inter-Quartile Range|Median
2651522|NCT01661712|Primary|4% Oxygen Desaturation Index (ODI, 4%)|"The primary outcome measure for this trial is the 4% oxygen desaturation index (ODI, 4%) per hour of sleep (h-1). The 4% ODI was chosen as primary outcome parameter over the AHI because an incomplete re-opening of the upper airway during an ongoing apnoeic effort caused by transcutaneous electrical stimulation (CTES) may result in a nominal increase of the AHI. We consider that the 4% ODI would be a more robust marker for the severity of sleep apnoea, low average oxygen levels indicating obesity-hypoventilation syndrome which will be an exclusion criterion.~Although a specific cut off is not well defined a 4% ODI ≥5 represent mild OSA whilst a 4% ODI ≥15 represents moderate-severe OSA. Normal range is usually considered 0-5 events/hour."|1st sleep study compared to 2nd sleep study (randomised order of intervention/sham or sham/intervention)||||oxygen desaturation events/hour||Inter-Quartile Range|Median
2651523|NCT01661686|Secondary|Median Survival After SEMS Placement|Survival from stent placement until death or placement of second stent|From stent placement until death or placement of second stent||||days||Full Range|Median
2651524|NCT01661686|Secondary|Number of Participants in Whom a Major Complication Has Occured|A major adverse event was defined as a life-threatening event, including perforation, major haemorrhage, severe pain (NRS pain score ≥ 7), pneumonia, stridor and fistula.|From stent placement until death or placement of second stent, assessed up to 6 months||||Participants|||Count of Participants
2651525|NCT01661686|Secondary|Number of Participants With Clinical Success Defined as Improvement of Dysphagia Score|"Clinical success was defined as an improvement of dysphagia (at least 1 point reduction in the Dysphagia score) during follow-up.~Dysphagia scores will be obtained at time point: t=0, t= 1 week, t=2 weeks, t=1 month, t=3 months and t= 6 months"|From stent placement until death or placement of second stent, assessed up to 6 months.||||Participants|||Count of Participants
2651527|NCT01661686|Primary|Number of Participants With Recurrent Dysphagia.|This is defined as occurrence of dysphagia due to a stent or tumor related cause. These include tumor in- or overgrowth, stent migration, stent fracture or food impaction.|From stent placement (t=0) until death or placement of second stent, assessed up to 6 months.|One patient, which was allocated to a FC SEMS, was excluded for analysis. In this patient the SEMS could not be inserted due to an acute cardiovascular event at the start of the endoscopic procedure. A total of 97 patients were included for final analysis, 48 patients in FC SEMS and 49 patients in the PC group.|||Participants|||Count of Participants
2651528|NCT01661621|Secondary|The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day|"Efficacy:~Using the the the International Prostate Symptom Score (IPSS) quality of life (QoL) score to compare the efficacy in Group 1 and Group 2 from baseline to 1month.~The IPSS quality of life question score on a 7-point scale ranging from 0 Delighted to 6 Terrible.~IPSS-QoL ranges 0 to 6 (Delighted to Terrible)~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month||||units on a scale||Standard Deviation|Mean
2651529|NCT01661621|Secondary|The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day|"Efficacy:~Using the the IPSS subscore (IPSS Storage) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.~The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.~The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month||||units on a scale||Standard Deviation|Mean
2651530|NCT01661621|Secondary|The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day|"Efficacy:~Using the the IPSS subscore (IPSS Voiding) questionnaires to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.~The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.~The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month||||units on a scale||Standard Deviation|Mean
2651531|NCT01661621|Secondary|The Postvoid Residual Volume (PVR) After the Treatment Day|"Efficacy:~Net change used the the postvoid residual volume (PVR) in Group 1 and Group 2 from baseline to 1 month.~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month||||mL||Standard Deviation|Mean
2651532|NCT01661621|Secondary|The Voided Volume After the Treatment Day|"Efficacy:~Net change used the the voided volume in Group 1 and Group 2 from baseline to 1 month.~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month||||mL||Standard Deviation|Mean
2651533|NCT01661621|Secondary|The Maximum Flow Rate (Qmax) After the Treatment Day|"Efficacy:~Net change used the the maximum flow rate (Qmax) in Group 1 and Group 2 from baseline to 1 month.~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month||||mL/s||Standard Deviation|Mean
2651534|NCT01661621|Secondary|The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day|"Efficacy:~Using the total International Prostate Symptom Score (IPSS) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.~The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS-voiding), 3 storage questions (IPSS-Storage) The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always.~Total IPSS score = IPSS-voiding + IPSS-Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness"|Baseline and 1 month||||units on a scale||Standard Deviation|Mean
2651535|NCT01661621|Primary|The Global Response Assessment (GRA) After the Treatment Day|"Efficacy Using global response assessment (GRA) to compare the efficacy in Group 1 and Group 2 from baseline to 1month.~The global response assessment on a 6-point scale ranging from 1 No problems at all to 6 Many severe problems.~Changes of the global response assessment (GRA) improved or reduction by 1 points.~Change = Baseline minus Month 1 value~Safety:~Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness"|1 month after initial treatment||||participants|||Number
2651536|NCT01661595|Other Pre-specified|Hematocrit Level Measured at Week 8|Hematocrit was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 35.7 - 45.2%.|week 8||||percent of red blood cells||Standard Deviation|Mean
2651537|NCT01661595|Other Pre-specified|Hematocrit Level Was Measured at 4 Weeks|Hematocrit was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 35.7 - 45.2%.|4 weeks||||percent of red blood cells||Standard Deviation|Mean
2651538|NCT01661595|Other Pre-specified|Hematocrit Level Measured at Week 0|Hematocrit was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 35.7 - 45.2%.|week 0||||percent of red blood cells||Standard Deviation|Mean
2651539|NCT01661595|Other Pre-specified|Hemoglobin Level Measured at Week 8|Hemoglobin was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 11.6 - 15.0 g/dL.|week 8||||g/dL||Standard Deviation|Mean
2651540|NCT01661595|Other Pre-specified|Hemoglobin Level Measured at Week 4|Hemoglobin was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 11.6 - 15.0 g/dL.|week 4||||g/dL||Standard Deviation|Mean
2651541|NCT01661595|Other Pre-specified|Hemoglobin Level at Week 0|Hemoglobin was measured by University of Texas Medical Branch Clinical Laboratory. Normal ranges are 11.6 - 15.0 g/dL.|week 0||||g/dL||Standard Deviation|Mean
2651661|NCT01660451|Secondary|PFS Based on Investigator Assessment|PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).|Baseline up to the last patient has completed the 16 weeks of treatment|FAS included all patients assigned to study treatment.|||days||95% Confidence Interval|Median
2651542|NCT01661595|Secondary|Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 8|Fatigue symptoms will be measured using the 30-item Multidimensional Fatigue Symptom Inventory - Short Form, a validated measure that yields one overall score of total fatigue calculated using five sub scales (general, physical, emotional, mental, vigor). With the exception of the vigor sub scale, higher scores indicate greater fatigue. Total fatigue score is calculated by summing the sub categories (general, physical, emotional and mental) and subtracting vigor. Total scores range from -24 to 96, with a higher score indicating more fatigue.|week 8||||scores on a scale||Standard Deviation|Mean
2651543|NCT01661595|Secondary|Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 4|Fatigue symptoms will be measured using the 30-item Multidimensional Fatigue Symptom Inventory - Short Form, a validated measure that yields one overall score of total fatigue calculated using five sub scales (general, physical, emotional, mental, vigor). With the exception of the vigor sub scale, higher scores indicate greater fatigue. Total fatigue score is calculated by summing the sub categories (general, physical, emotional and mental) and subtracting vigor. Total scores range from -24 to 96, with a higher score indicating more fatigue.|week 4|1 subject did not complete the week 4 MFSI questionnaire|||scores on a scale||Standard Deviation|Mean
2651544|NCT01661595|Secondary|Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 0|Fatigue symptoms will be measured using the 30-item Multidimensional Fatigue Symptom Inventory - Short Form, a validated measure that yields one overall score of total fatigue calculated using five sub scales (general, physical, emotional, mental, vigor). With the exception of the vigor sub scale, higher scores indicate greater fatigue. Total fatigue score is calculated by summing the sub categories (general, physical, emotional and mental) and subtracting vigor. Total scores range from -24 to 96, with a higher score indicating more fatigue.|Week 0||||scores on a scale||Standard Deviation|Mean
2651545|NCT01661595|Secondary|Walking Distance at 100% Effort as Measured by Walking Test After 4 Weeks of Active Drug|Walking performance will be assessed during 2 minutes of walking in long corridor hallways. Subjects will be asked to walk at 100% effort (as quickly as they can safely walk without running) for 2 minutes. Distance traveled for the 2 minutes will be recorded. The walking test will be completed at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.|after 4 weeks of active drug|1 subject did not complete the walking test.|||meter||Standard Deviation|Mean
2651546|NCT01661595|Secondary|Walking Distance at 100% Effort as Measured by Walking Test After 4 Weeks of Placebo|Walking performance will be assessed during 2 minutes of walking in long corridor hallways. Subjects will be asked to walk at 100% effort (as quickly as they can safely walk without running) for 2 minutes. Distance traveled for the 2 minutes will be recorded. The walking test will be completed at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.|after 4 weeks of placebo|1 subject did not complete the walking test|||meters||Standard Deviation|Mean
2651547|NCT01661595|Secondary|Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 8.|Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.|week 8||||kilograms||Standard Deviation|Mean
2651548|NCT01661595|Secondary|Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 4.|Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.|week 4||||kilograms||Standard Deviation|Mean
2651549|NCT01661595|Secondary|Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 0.|Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.|week 0||||kilograms||Standard Deviation|Mean
2651550|NCT01661595|Secondary|Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 8.|Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.|week 8||||kilograms||Standard Deviation|Mean
2651551|NCT01661595|Secondary|Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 4.|Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.|week 4||||kilograms||Standard Deviation|Mean
2651552|NCT01661595|Secondary|Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 0.|Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.|week 0||||kilograms||Standard Deviation|Mean
2651553|NCT01661595|Secondary|Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Active Drug|Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force. Isokinetic strength will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.|after 4 weeks of active drug||||Newton-Meters||Standard Deviation|Mean
2651554|NCT01661595|Secondary|Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Placebo.|Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force. Isokinetic strength will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.|after 4 weeks of placebo||||Newton-Meters||Standard Deviation|Mean
2651555|NCT01661595|Secondary|Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Active Drug.|Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction and 15 seconds of rest. 1 set of 3 contractions at 100% force performed. Isometric strength was measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.|after 4 weeks of active drug||||Newton-Meters||Standard Deviation|Mean
2651750|NCT01659320|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|A published and widely-used scale for rating depression, the Montgomery Asberg Depression Rating Scale total scores range from 0-60. Higher scores indicate greater severity of depression. Total scores are reported with no subscales.|8 weeks|Among 13 subjects who completed the study.|||units on a scale||Standard Deviation|Mean
2651556|NCT01661595|Secondary|Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Placebo|Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction and 15 seconds of rest. 1 set of 3 contractions at 100% force performed. Isometric strength was measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.|after 4 weeks of placebo||||Newton-Meters||Standard Deviation|Mean
2651557|NCT01661595|Primary|Exercised Induced Fatigability as Measured by Fatigue Rating Scale After 4 Weeks of Active Drug|The fatigue rating scale is a scale from 0 to 10 with 0 being no fatigue at all and 10 being the worst fatigue the subject can imagine. The subject is asked to rate their level of fatigue in their leg. This test was performed before and immedicately after the Biodex leg fatigue test. Data is presented as change in scale from pre fatigue test to post fatigue test, with a higher score indicating a greater level of fatigue.|after 4 weeks of active drug||||units on a scale||Standard Deviation|Mean
2651558|NCT01661595|Primary|Exercised Induced Fatigability as Measured by Fatigue Rating Scale After 4 Weeks of Placebo|The fatigue rating scale is a scale from 0 to 10 with 0 being no fatigue at all and 10 being the worst fatigue the subject can imagine. The subject is asked to rate their level of fatigue in their leg. This test was performed before and immedicately after the Biodex leg fatigue test after 4 weeks of placebo. Data is presented as change in scale from pre fatigue test to post fatigue test, with a higher score indicating a greater level of fatigue.|after 4 weeks of placebo||||units on a scale||Standard Deviation|Mean
2651559|NCT01661595|Primary|Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Active Drug|Isokinetic Fatigue Measure (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 50 contractions were performed at 100% force, one contraction every second. Isokinetic fatigue will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug. Data is presented as mean maximum force over all 50 kicks.|after 4 weeks of active drug||||Newton-Meters||Standard Deviation|Mean
2651560|NCT01661595|Primary|Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Placebo|Isokinetic Fatigue Measure (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 50 contractions were performed at 100% force, one contraction every second. Isokinetic fatigue will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug. Data is presented as mean maximum force over all 50 kicks.|after 4 weeks of placebo||||Newton-Meters||Standard Deviation|Mean
2651561|NCT01661283|Secondary|Utility of 3-D MRI Analysis in Comparison to 1-D and 2-D Measurements to More Sensitively Monitor Response to Everolimus in Combination With Bevacizumab|To evaluate the utility of 3-D MRI analysis in comparison to 1-D and 2-D measurements to more sensitively monitor response to everolimus in combination with bevacizumab|greater than or equal to 4 months|Imaging studies of sufficient quality to analyze tumors were not collected. Therefore, unable to analyze volumes and compare 3-D to 1-D and 2-D measurements.||||||
2651562|NCT01661283|Secondary|Vascular Endothelial Growth Factor (VEGF) and Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Levels at Baseline and Pre-Cycles 3 and 5|To assess changes in Vascular Endothelial Growth Factor (VEGF) and Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Levels in peripheral blood specimens during treatment.|Baseline, Pre-Cycle 3, Pre-Cycle 5|Paired samples for analysis were collected for 14 patients at baseline and time of first restaging and 8 patients at time of second restaging.|||pg/mL||Full Range|Median
2651563|NCT01661283|Secondary|Relationship Between Response to Everolimus in Combination With Bevacizumab and the Presence of NF1 Mutations or NF1 Inactivation in MPNST Tumor Samples|To explore the relationship between response to everolimus in combination with bevacizumab and the presence of NF1 mutations or NF1 inactivation in MPNST tumor samples|greater than or equal to 4 months|Tumor samples were not analyzed for NF1 mutations.||||||
2651564|NCT01661283|Secondary|Number of Participants With Response Stratified by Individuals With Sporadic or NF1 Associated MPNST|To explore differences in the response rate to everolimus in combination with bevacizumab in individuals with sporadic and NF1 associated MPNST. Responses include confirmed partial and complete responses and disease stability for four or more treatment cycles based on WHO Response Criteria. Per WHO for target lesions: Complete Response (CR): Disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart. Partial Response (PR): A > 50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive. Stable Disease (SD): A 50% decrease in total tumor area cannot be established nor has a 25% increase in the size of one or more measurable lesions been demonstrated.|Assessed at Baseline and prior to Cycle 3, 5, 7, 9, etc., for up to 2 years. 1 cycle =28 days|The rows are broken up by patients with NF1 associated MPNST (n=17) and sporadic MPNST (n=8)|||Participants|||Count of Participants
2651565|NCT01661283|Secondary|Spectrum of Germline NF1 Mutations in Individuals With NF1 Associated MPNSTs|To evaluate the spectrum of germline NF1 mutations in individuals with NF1 associated MPNSTs|greater than or equal to 4 months|NF1 germline mutations were not analyzed.||||||
2651566|NCT01661283|Primary|Clinical Benefit Rate (Complete Response, Partial Response, and Stable Disease at ≥ 4 Months Using World Health Organization (WHO) Criteria) of Everolimus in Combination With Bevacizumab|"Evaluate if the combination of the mTOR inhibitor everolimus combined with the angiogenesis inhibitor bevacizumab would result in a modest clinical benefit rate, which included confirmed partial and complete responses and disease stability for four or more treatment cycles based on WHO Response Criteria. Per WHO for target lesions: Complete Response (CR): Disappearance of all known disease, determined by two consecutive observations not less than 4 weeks apart.~Partial Response (PR): A > 50% decrease in the total tumor load of the lesions that have been measured to determine the effect of therapy not less than four weeks apart. The observations must be consecutive. Stable Disease (SD): A 50% decrease in total tumor area cannot be established nor has a 25% increase in the size of one or more measurable lesions been demonstrated."|Assessed at Baseline and prior to Cycle 3, 5, 7, 9, etc., for up to 2 years. 1 cycle =28 days||||Participants|||Count of Participants
2651567|NCT01661270|Secondary|Percentage of Participants With Objective Response|Objective response rate was defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR), as assessed by Investigators and the IRC according to RECIST 1.0 criteria, relative to the total number of participants in the relevant analysis population. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions but persistence of 1 or more non-target lesions not qualifying for either CR or progressive disease (PD) and no new lesions.|26.6 months|ITT population.|||percentage of participants||95% Confidence Interval|Number
2651568|NCT01661270|Secondary|Overall Survival (OS)|OS was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the earliest between the last date of the participants was known to be alive and the study cut-off date. Analysis was performed by Kaplan-Meier method.|31.6 months|ITT population.|||months||95% Confidence Interval|Median
2651569|NCT01661270|Primary|Progression-free Survival (PFS)|PFS was defined as the time interval from the date of randomization to the date of first observation of either tumor progression or death due to any cause. Tumor assessment was performed by Independent Review Committee (IRC) as per response evaluation criteria in solid tumors (RECIST) version 1.0. Progression was defined as at least 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study or absolute increase and at least 5 mm, progression of existing non-target lesions, or presence of new lesions. PFS was calculated by Kaplan-Meier estimates.|26.7 months|Intent-to-Treat (ITT) population included all randomized participants.|||months||95% Confidence Interval|Median
2651570|NCT01661205|Secondary|Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores|"Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline.~This scale has 16 items to assess frequency of occurrence on a scale: Never; Rarely; Sometimes; Often; Always. These rating correspond to numerical values of: 1, 2, 3, 4, and 5, respectively. AF Frequency range from 0 to 80 . Higher scores indicating greater symptomatology.~The same items are also used to assess severity on a scale: Mild; Moderate; Severe. Corresponding to 1, 2, and 3, respectively. AF Severity score range from 0 to 48. Higher scores indicating greater symptomatology.~Negative change from baseline compared to 12-months represents an improvement in AF symptomatology ."|12 month follow-up||||percentage of from baseline||Standard Deviation|Mean
2651571|NCT01661205|Secondary|Number of Subjects With Direct Current (DC) Cardioversion||12 month follow-up||||Participants|||Count of Participants
2651572|NCT01661205|Secondary|Number of Subjects With Reinterventions||12 month follow-up||||Participants|||Count of Participants
2651573|NCT01661205|Secondary|Number of Subject Without Atrial Fibrillation|AF free with or without the need of antiarrhythmic drugs|6 and 12 month follow-up||||Participants|||Count of Participants
2651574|NCT01661205|Secondary|Number of Subjects With Acute Procedure Success|"Defined as subject meeting all of the following criteria upon completion of the index-EP procedure~Isolation/block of all pulmonary veins (e.g. 4 of 4 veins);~Bi-directional cavotricuspid isthmus block;~Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines);~Superior Vena Cava (SVC) isolation, if encircling SVC lesion performed."|Day 0||||Participants|||Count of Participants
2651575|NCT01661205|Secondary|Number Subjects With Serious Device or Procedure Related Adverse Event Rate||12 month follow-up||||Participants|||Count of Participants
2651576|NCT01661205|Primary|Number of Subjects With Absence of Atrial Fibrillation|Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy.|12 month follow-up|Subjects who are evaluable for primary efficacy endpoint, defined as all subjects in whom the minimally invasive staged epicardial/ endocardial ablation procedure is attempted and in whom the index-EP procedure and required post-procedure and 12 month follow-up efficacy endpoint assessment has been performed.|||Participants|||Count of Participants
2651577|NCT01661205|Primary|Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.|Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms.|30 days post-index procedure or hospital discharge|Number of treated subjects. Although 26 subjects were anesthetized only 25 subjects underwent epicardial procedure per protocol. Physician decided not to treat one of the anesthetized subjects. Another case was aborted and converted to open chest cardioversion. Twenty-four patients underwent endocardial catheter procedures.|||Participants|||Count of Participants
2651578|NCT01661179|Primary|Objective Response Rate Within the First 56 Weeks After the First Dose of Vandetanib|ORR is defined as the percentage of patients who have a confirmed CR (Disappearance of all target lesions) or PR (>=30% decrease in the sum of diameters of target lesions) prior to any evidence of progression as defined by RECIST V1.1. This percentage is calculated with only patients who had at least measurable lesion in the efficacy analysis set.|Sept 2012 to May 2014|All patients with post-baseline efficacy assessments|||percentage of participants||95% Confidence Interval|Number
2651579|NCT01661140|Secondary|Change in Productivity and Regular Daily Activities Affected by Rheumatoid Arthritis Assessed Using the WPAI-SHP|The WPAI-SHP questionnaire assesses work productivity and activity impairment. It is a patient-reported assessment regarding hours missed and hours worked at employment and degree to which a specified health problem affected work productivity and regular activities. It consists of 6 questions to assess the impact of a specific health problem on work productivity and on regular daily activities. Assessments were made using a visual analogue scale ranging from 0 to 10 where 0 = minimum impact and 10 = maximum impact.|Randomization (Week 24), Week 60, 72|Participants in the ITT population with available data at the respective time points were analyzed.|||units on a scale||Full Range|Median
2651592|NCT01661140|Secondary|Percentage of Participants Who Achieve a Disease Activity Score In 28 Joints (DAS28) <= 3.2|The DAS28 index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. Participants who achieve score <=3.2 at weeks 60 and 72 were reported.|Week 60, 72|ITT population included all randomized participants.|||percentage of participants|||Number
2651580|NCT01661140|Secondary|Hours Actually Worked and Work Hours Missed Assessed Using the WPAI-SHP|The WPAI-SHP questionnaire assesses work productivity and activity impairment. It is a patient-reported assessment regarding hours missed and hours worked at employment and degree to which a specified health problem affected work productivity and regular activities. It consists of 6 questions to assess the impact of a specific health problem on work productivity and on regular daily activities. Reported here are hours actually worked, work hours missed due to rheumatoid arthritis (RA), work hours missed due to other reasons and the change from Week 24 for each of these parameters reported at Week 60 and Week 72.|Randomization (Week 24), Week 60, Week 72|Participants in the ITT population with available data were analyzed.|||hours||Full Range|Median
2651581|NCT01661140|Secondary|Number of Subjects Employed Assessed Using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP)|The WPAI-SHP questionnaire assesses work productivity and activity impairment. It is a patient-reported assessment regarding hours missed and hours worked at employment and degree to which a specified health problem affected work productivity and regular activities. It consists of 6 questions to assess the impact of a specific health problem on work productivity and on regular daily activities.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.|||participants|||Number
2651582|NCT01661140|Secondary|Percentage of Participants Able to Discontinue Methotrexate||Week 0 up to Week 60|Data were not collected for this outcome measure.||||||
2651583|NCT01661140|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE was any adverse event that can be fatal, life threatening, requires long or prolong hospitalization, results in persistent or significant disability/incapacity, congenital anomaly or significant medical event in the investigator's judgment.|Week 0 up to Week 72|Safety population included all the randomized participants.|||participants|||Number
2651584|NCT01661140|Secondary|Percentage of Participants With Anemia||Week 0 up to Week 72|Safety population included all the randomized participants.|||percentage of participants|||Number
2651585|NCT01661140|Secondary|Percentage of Participants With Improvement in Physical Function Using 12-item Short Form Health Survey [SF-12]) at Week 60 and 72|Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. Improvement was defined as a decrease from Week 24 to Week 60 and 72. Reported is the percentage of subjects with an improvement in SF-12 score.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.|||percentage of participants|||Number
2651586|NCT01661140|Secondary|Percentage of Participants With Improvement in Physical Function Using Functional Assessment of Chronic Illness Therapy - Fatigue [FACIT-F] at Week 60 and 72|The FACIT-fatigue assessment was a 13-item questionnaire with participants scoring each item on a 5-point scale (not at all; a little bit; somewhat; quite a bit and very much). The total score ranges from 0 to 65 and higher scores indicate more fatigue. Improvement was defined as a decrease from Week 24 to Week 60 and 72. Reported is the percentage of subjects with an improvement in total FACIT score.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.|||percentage of participants|||Number
2651587|NCT01661140|Secondary|Percentage of Participants With Improvement in Physical Function Using Health Assessment Questionnaire [HAQ] at Week 60 and 72|The HAQ-disability index (DI) evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores and 20 questions. Each category contains multiple questions, which were answered using a 4-point scale from 0 to 3. The overall index score was an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. Improvement was defined as a decrease from Week 24 to Week 60 and 72. Reported is the percentage of participants with an improvement in HAQ-DI score.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.|||percentage of participants|||Number
2651588|NCT01661140|Secondary|Percentage of Participants Who Achieve Simplified Disease Activity Index (SDAI) Remission (SDAI < 3.3) at Week 60 and 72|Simplified Disease Activity Index (SDAI) was an index for measuring disease activity in RA. The index was calculated using the following formula: CDAI: SJC28 + TJC28 + PGA (10 cm VAS) + PhGA (10 cm VAS + C-Reactive Protein (CRP). VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.|||percentage of participants|||Number
2651589|NCT01661140|Secondary|Percentage of Participants Who Achieve Clinical Disease Activity Index (CDAI) Remission (CDAI < 2.8) at Week 60 and 72|Clinical Disease Activity Index (CDAI) was an index for measuring disease activity in RA. The index was calculated using the following formula: CDAI: SJC28 + TJC28 + patient global assessment of disease (PGA) 10 centimeter [cm] Visual Analog Scale [VAS] + physician global assessment of disease (PhGA) 10 cm VAS. VAS assessments involved a 10 cm horizontal scale from 'no disease activity' to 'maximum disease activity.' CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity.|Randomization (Week 24), Week 60, 72|ITT population included all randomized participants.|||percentage of participants|||Number
2651590|NCT01661140|Secondary|Percentage of Participants Who Achieve Change in Disease Activity Score (cDAS) >=1.2|The DAS28 index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. Participants who achieve cDAS28 >=1.2 score at weeks 60 and 72 were reported.|Week 60, 72|ITT population included all randomized participants.|||percentage of participants|||Number
2651591|NCT01661140|Secondary|Percentage of Participants Who Achieve DAS28 Remission (DAS28 < 2.6)|The DAS28 index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. Participants who achieve DAS28 remission score <2.6 at weeks 60 and 72 were reported.|Week 60, 72|ITT population included all randomized participants.|||percentage of participants|||Number
2651593|NCT01661140|Secondary|Percentage of Participants Who Achieve Score of <=1 in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 60 and 72|Percentage of participants who achieve score of =1 in TJC and SJC at week 60 and 72 were reported. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28.|Week 60, 72|ITT population included all randomized participants.|||percentage of participants|||Number
2651594|NCT01661140|Secondary|Change From Baseline in Disease Activity Score In 28 Joints (DAS28) Score at Week 72|The DAS28 defined as a combined index for measuring disease activity in rheumatoid arthritis (RA). The index included swollen (range 0-28) and tender joint counts (TJC) (range 0-28), acute phase response Erythrocyte Sedimentation Rate (ESR), and general health status (range 1-100). The index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Randomization (Week 24), Week 72|ITT population included all randomized participants. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2651595|NCT01661140|Secondary|Change From Baseline in Disease Activity Score In 28 Joints (DAS28) Score at Week 60|The DAS28 defined as a combined index for measuring disease activity in rheumatoid arthritis (RA). The index included swollen (range 0-28) and tender joint counts (TJC) (range 0-28), acute phase response Erythrocyte Sedimentation Rate (ESR), and general health status (range 1-100). The index was calculated using the following formula: The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x patient global assessment of disease activity]. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Randomization (Week 24), Week 60|ITT population included all randomized participants. Here, number of participants analyzed signifies those participants who were evaluable for this end point.|||units on a scale||Standard Deviation|Mean
2651596|NCT01661140|Primary|Percentage of Participants Maintaining Previous Disease Activity (European League Against Rheumatism [EULAR] Response) From Week 24 (Time of Randomization) to Week 60|Response was determined using EULAR criteria based upon (Disease Activity Score In 28 Joints) DAS28 absolute scores at the assessment visit and the DAS28 reduction from the reference visit. Participants with a score lesser than or equal to (<=) 3.2 and reduction of greater than (>) 1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction <=0.6 points, were assessed as non-responders with response recorded as 'none.'|From randomization to Week 60|Intention to treat (ITT) population included all randomized participants.|||percentage of participants|||Number
2651597|NCT01661114|Secondary|Median Overall Survival of Previously Treated and Previously Untreated Patients|To assess the overall survival following treatment with gemcitabine, 5-FU and cisplatin.|1 year|Patients with metastatic adenocarcinoma of the pancreas or biliary tract, previously untreated or having received one cytotoxic regimen for advanced disease.|||Months||95% Confidence Interval|Median
2651598|NCT01661114|Primary|The Percentage of Untreated and Previously Treated Patients That Had a Partial Response to Treatment|"The primary objective of this clinical trial is to estimate the response rate to treatment with the triplet chemotherapy regimen of gemcitabine, infusional 5-FU, and cisplatin, in untreated and previously treated advanced pancreatic and biliary cancer patients.~Partial Response (PR) is defined as At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."|28 days|Patients with metastatic adenocarcinoma of the pancreas or biliary tract, previously untreated or having received one cytotoxic regimen for advanced disease.|||percentage of patients||95% Confidence Interval|Number
2651599|NCT01661088|Secondary|Median Overall Survival Time|To estimate overall survival as a function of time from study enrollment.|up to 2 years||||months||95% Confidence Interval|Median
2651600|NCT01661088|Secondary|Median Progression-free Survival Time|To estimate progression-free survival as a function of time from study enrollment. Progression is defined as at least a 20% increase in the LD (longest diameter) of the primary lesion or the appearance of one or more new lesions|up to 2 years||||months||95% Confidence Interval|Median
2651601|NCT01661088|Primary|The Percentage of Patients That Underwent an R0 Resection|To determine the frequency of achieving an R0 resection using a neoadjuvant regimen of FOLFIRINOX followed by IMRT concurrent with fixed dose rate (FDR)-gemcitabine in patients with borderline resectable pancreatic cancer. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.|6 months||||percentage of patients|||Number
2651602|NCT01661062|Primary|Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate|Spearman rank-based correlation coefficients were calculated for the association between saliva flow rate and the delivered mean parotid doses at several timepoints (Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months).|24 months|36 parotid glands were evaluable from 18 patients at baseline, 34 parotid glands were evaluable at 3-6 months, 32 glands were evaluable at 12 months, 20 were evaluable at 18 months and 8 at 24 months.|||correlation coefficient|||Number
2651603|NCT01661062|Secondary|The Median Delivered Dose of Radiation to the Parotid Gland||7 weeks||||Gy||Full Range|Median
2651604|NCT01661062|Secondary|Improvement of Image Quality|Use acquired data to further improve cone beam CT reconstruction techniques and image quality.|36 months|||||||
2651605|NCT01661062|Primary|Rate of Movement of Normal Tissue|The primary outcome measure of this study is to characterize patient-specific target and normal tissue movement.|approximately 7 weeks|||||||
2651621|NCT01660893|Secondary|Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hg||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
2651622|NCT01660893|Secondary|Number of Participants With Heart Rate Lower Than 50 Bpm||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
2651606|NCT01660906|Other Pre-specified|Number of Participants With a Major Molecular Response (MMR) and MR 4.5 After Switching to Dasatinib|Molecular responses were assessed at 6 and 12 months after switching to dasatinib to determine if these baseline responses could be maintained. MR4.5, the number of treated participants with BCR-ABL transcripts ≤ 0.0032% (IS) at 6 and 12 months from the date of dasatinib initiation; MMR, Major Molecular Response = 3-log reduction in BCR-ABL gene transcripts from a standardized baseline.|6 and 12 months|All treated participants.|||Participants|||Count of Participants
2651607|NCT01660906|Secondary|The Percentage of Participants With at Least 1 Imatinib-related Grade 1 or Grade 2 Chronic Adverse Events (AEs) That Improved Without Worsening Within 3 Months of Switching to Dasatinib|Dasatinib treatment was administered and its impact on the Imatinib-related Grade 1/2 adverse events was assessed. The percentage of participants is based on the number that had pre-existing Imatinib-related AEs. Measure assesses the participants with reduction or improvement of at least 1 Imatinib-related Grade 1 or Grade 2 chronic AE, without a worsening of any Imatinib-related, chronic adverse events after Dasatinib treatment. The severity of an adverse event is ranked based on grades that range from 1 to 4. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4= Potentially Life-threatening or disabling. Improved, AE grade reduced from Grade 2 to Grade 1. Worsened, Grade Increased. Confidence interval from Clopper-Pearson method.|3 months|All treated participants.|||percentage of participants||95% Confidence Interval|Number
2651608|NCT01660906|Secondary|Number of Participants With at Least 1 AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as Outcome|SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug, dasatinib.|Date of first dose to 30 post last dose of study drug, an average of 3 years|All treated participants.|||Participants|||Count of Participants
2651609|NCT01660906|Secondary|Mean Change From Baseline in Patient Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib|The EORTC QLQ-C30 questionnaire is completed by study participants to assess quality of life through nine multi-item scales: five functional scales (physical, role, cognitive, emotional and social functioning); three symptom scales (fatigue, pain and nausea/vomiting); and a global health status/QoL scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All of the scales and single-item measures were evaluated at baseline and after switching to Dasatinib as an average raw score that was standardized by transformation, so that final scores were on a range in score from 0 to 100. A high score for a functional scale represents a healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale and single-item measures represents a high level of problematic symptomatology.|Baseline to 6, 12 months|All treated participants|||units on a scale||Standard Deviation|Mean
2651610|NCT01660906|Secondary|Mean Change From Baseline in Patient Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory - Chronic Myeloid Leukemia (MDASI-CML) Score After Switching to Dasatinib|The MD Anderson Symptom Inventory Chronic Myeloid Leukemia (MDASI-CML) is a validated questionnaire completed by study participants to assess symptom severity and symptom interference on daily function. These categories are divided into 5 domain summary scores: Core Symptom Severity Score, Interference Score, Symptom Severity Score, CML-Specific Symptom Severity Score, and 5 Most Severe Symptom Score. Scores were evaluated at baseline and after switching to Dasatinib on a range from 1 to 10; 1=not present/did not interfere, 10=as bad as you can imagine/interfered completely.|Baseline to 3, 6, 12 months|All treated participants.|||units on a scale||Standard Deviation|Mean
2651611|NCT01660906|Primary|The Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment|Dasatinib treatment was administered and its impact on the imatinib-related Grade 1/2 adverse events was assessed. The severity of an adverse event is ranked based on grades that range from 1 to 4. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4= Potentially Life-threatening or disabling. Resolved, AE no longer present or resolution of imatinib-related chronic Grade 1 or Grade 2 non-hematologic AEs. Improved, AE grade reduced from Grade 2 to Grade 1. Unchanged, AE did not improve or worsen or no change in grade. Worsened, grade Increased.|3 months after switch to dasatinib|All treated participants.|||adverse event(s)|||Number
2651612|NCT01660893|Secondary|Absolute Maximum Change From Baseline in Heart Rate||from baseline to 120 minutes following drug administration||||bpm||Standard Deviation|Mean
2651613|NCT01660893|Secondary|The Profile Over Time of Diastolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
2651614|NCT01660893|Secondary|The Profile Over Time of Systolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
2651615|NCT01660893|Secondary|Alcohol Sniff Test|The change from screening in the the distance from the nose (in centimeters) that a patient is able to detect the smell of an alcohol swab.|administered at approximately 24 hours after drug administration||||cm||Standard Deviation|Mean
2651616|NCT01660893|Secondary|The Profile Over Time of Heart Rate||from baseline to 120 minutes following drug administration||||bpm||Standard Deviation|Mean
2651617|NCT01660893|Secondary|Absolute Maximum Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure||from baseline to 120 minutes following drug administration||||mmHg||Standard Deviation|Mean
2651618|NCT01660893|Secondary|Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
2651619|NCT01660893|Secondary|Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 90 mm Hg||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
2651620|NCT01660893|Secondary|Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hg||at any time within 120 minutes following drug administration||||Participants|||Count of Participants
2651626|NCT01660815|Primary|Whole Body Radiation Dosimetry|Radiation dose values (millisieverts/megabecquerel [mSv/MBq]) were calculated for target organs, including the adrenals, brain, breasts, gall bladder wall, heart wall, kidneys, lower large intestine wall, liver, lungs, muscle, ovaries, osteogenic cells, pancreas, red marrow, skin, small intestine, spleen, stomach wall, testes, thymus, thyroid, total body, upper large intestine wall, urinary bladder wall, and uterus.|0-360 minutes|Analysis population includes the 6 subjects who completed the study and had valid imaging data for quantitative analysis.|||mSv/MBq||Standard Deviation|Mean
2651627|NCT01660802|Secondary|Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Modified Intent-to-Treat: all randomized and treated patients|||Percentage of Patients|||Number
2651628|NCT01660802|Secondary|Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. A decrease in the number of letters read correctly (negative number) means that vision has worsened.|Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6|Modified Intent-to-Treat: all randomized and treated patients|||Letters Read Correctly||Standard Deviation|Mean
2651629|NCT01660802|Secondary|Average Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, 6 Months|Modified Intent-to-Treat: all randomized and treated patients|||Letters Read Correctly||Standard Deviation|Mean
2651630|NCT01660802|Primary|Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.|Baseline, 6 Months|Modified Intent-to-Treat: all randomized and treated patients|||Patients|||Number
2651631|NCT01660763|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID48).|"SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. Range of SPID48 scores were -239 to 417.~Time-weighted SPID48 = ∑ [T(i) - T(i-1)] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 hours"|48 hours||||Units on a scale||Standard Error|Least Squares Mean
2651632|NCT01660737|Secondary|Change of Symptom Tearing Eyes (Pre-post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
2651633|NCT01660737|Secondary|Change of Symptom Headache (Pre-post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
2651634|NCT01660737|Secondary|Change of Symtom Fatigue / Tiredness|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
2651635|NCT01660737|Secondary|Change of Symptom Rhinitis (Pre-post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
2651636|NCT01660737|Secondary|Change of Symptom Sneezing (Pre-post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
2651637|NCT01660737|Secondary|Change of Symptom Bronchial Complaints (Pre-post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
2651638|NCT01660737|Secondary|Change of Symptom Burning Eyes (Pre-post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
2651639|NCT01660737|Secondary|Change of Symptom Itching Eyes (Pre- Post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
2651640|NCT01660737|Secondary|Change of Symptom Dry Eyes (Pre- Post)|Request Scale (0=not present, 1=mild, 2=moderate, 3=strong)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
2651641|NCT01660737|Secondary|Numerical Rating Scale Well Beeing (Pre- Post)|Influence of allergy on the general well-being (scale from 0-no influence to 10 strong influence)|Change from Baseline (before treatment; week 0) to last visit (end of observation- approx. 4 weeks after baseline)||||participants|||Number
2651642|NCT01660737|Primary|Tolerability|Request of Tolerability using a 2-stage scale (very good tolerability, bad tolerability)|app. 4 weeks after baseline (treatment app. for 4 weeks)||||participants|||Number
2651643|NCT01660737|Primary|Efficacy of Pascallerg|Request of Efficacy using a 4-stage scale (very good efficacy, good efficacy, moderate efficacy, no efficacy)|appr. 4 weeks after baseline (after appr. 4 weeks of treatment)||||participants|||Number
2651644|NCT01660698|Primary|Comparison of Th2 Cytokines (IL-5) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake)|A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.|0 (baseline), 1, and 2 months||||ng/mL||Standard Deviation|Mean
2651645|NCT01660698|Secondary|Change From Baseline in Basophil Activation at 8 Weeks in ex Vivo Stimulated Whole Blood Cells||8 weeks|||||||
2651646|NCT01660698|Secondary|Change From Baseline in Immunoglobulin Levels in Serum Between Treatment Groups||8 weeks|||||||
2651647|NCT01660698|Secondary|Change From Baseline in Pro-inflammatory Cytokines (TNF-alpha, IL-1beta) at 8 Weeks in ex Vivo Stimulated Whole Blood Cells||8 weeks|||||||
2651648|NCT01660698|Secondary|Comparison Between Probiotic and Placebo at Baseline (Beginning of Product Intake), 1 Month and 2 Months (End of Product Intake)|TNSS Questionnaire were distributed at every visit (1 questionnaire for every week). The scored questionnaire were collected at subsequent visits. The symptom scores for nasal congestion, runny nose, nasal itching and sneezing were expressed as weekly sums (scale 0-3 for each symptom). The TNSS was the weekly sum for all the symptoms (scale 0-12). The TNSS data were analyzed as both monthly averages (at V2 and V3 compared to baseline V1) and weekly TNSS scores. Monthly TNSS scores were calculated as average over the 4 weeks preceding the visits. The higher the score is, the worse the outcome is.|Measures at baseline, 1, and 2 months||||units on a scale||Standard Deviation|Mean
2651649|NCT01660698|Primary|Comparison of Th2 Cytokines (IL-13) Between Placebo and Probiotic Groups at Baseline (Beginning of Product Intake), 4 Weeks (Mid Period of Product Intake) and 8 Weeks (End of Product Intake)|A maximum of 10 ml heparinized, venous blood will be collected during Visit 1, 2 and 3. Whole blood cells will be cultured for 120 hours (5 days) with culture medium with different stimuli. Cell supernatants will be collected and analyzed for different cytokines.|0 (baseline), 1 and 2 months||||ng/mL||Standard Error|Mean
2651650|NCT01660672|Other Pre-specified|Mean Time to Return to a BCS Score Greater Than or Equal to 4|Mean time from admission to a BCS score greater than or equal to 4. The BCS (Blantyre Coma Scale) is a 0-5 scale measuring motor response, verbal response and eye movement assessing the severity of coma in children with cerebral malaria. Lower scores correspond to more profound coma.|7 days||||hours||Full Range|Mean
2651651|NCT01660672|Other Pre-specified|Number of Participants Requiring AED During Admission|Number of participants who required AEDS during admission(including for breakthrough seizures in the LVT group) during admission.|7 days||||participants|||Number
2651652|NCT01660672|Other Pre-specified|Number of Subjects Exposed to Phenobarbitone Prior to Enrollment|Pre-enrollment exposure to phenobarbitone may impact LVT efficacy, and analysis base on this characteristic will be evaluated.|0 hour||||participants|||Number
2651653|NCT01660672|Other Pre-specified|Number of Subjects With Retinopathy at Enrollment|Retinopathy status may impact LVT efficacy and subject status will be analyzed based on this characteristic.|Upon admission||||participants|||Number
2651654|NCT01660672|Other Pre-specified|Number of Participants With Neurologic Sequelae at Discharge|Number of participants with neurologic sequelae at discharge|day 7||||participants|||Number
2651655|NCT01660672|Secondary|Range of Plasma Concentration of LVT Across All Individuals|Range of plasma LVT concentrations will be determined through HPLC method at eight timepoints post administration to evaluate LVT absorption and elimination in pediatric CM.|72 hours||||mcg/ml||Full Range|Mean
2651656|NCT01660672|Secondary|Toxicity Related to LVT|Toxicity including vomiting, aspiration, complications related to the NGT, laboratory parameters at 24 hours and 1 week post LVT administration, and an overall acute case fatality rate significantly above the consistent historical ward average for CM. Pk studies to evaluate LVT absorption and elimination in pediatric CM.|1 week||||participants|||Number
2651657|NCT01660672|Primary|Freedom From Seizure|Number of subjects free of seizure at 24 hours after initiation of treatment|24 hours||||individuals|||Number
2651658|NCT01660451|Secondary|Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Total Score at Week 16 - Part B|"HRQoL assessment was used to describe development of patients with copanlisib by using FACT-Lym questionnaire assessment tool. It contains 42 items (questions) covering HRQoL, common lymphoma symptoms and treatment side-effects. The FACT - General (FACT-G) questionnaire contains 27 items covering 4 core HRQoL subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 items) (FACT-Lym LymS), addressing issues typically experienced by lymphoma patients. Some of the issues covered include pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. FACT-Lym also asks patients about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. FACT-Lym total score range was 0-168, higher score indicates better HRQoL. Here, in the below table n signifies evaluable participants for the respective category."|Baseline up to the last patient has completed the 16 weeks of treatment|FAS included all patients assigned to study treatment. The analysis was performed by using last LOCF method.|||units on a scale||Inter-Quartile Range|Median
2651659|NCT01660451|Secondary|Functional Assessment of Cancer Therapy - Lymphoma Lymphoma Subscale (FACT-Lym LymS) at Week 16 - Part B|"HRQoL assessment was used to describe development of patients with copanlisib by using FACT-Lym questionnaire assessment tool. It contains 42 items (questions) covering HRQoL, common lymphoma symptoms and treatment side-effects. The FACT - General (FACT-G) questionnaire contains 27 items covering 4 core HRQoL subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 items) (FACT-Lym LymS), addressing issues typically experienced by lymphoma patients. Some of the issues covered include pain, itching, night sweats, trouble sleeping, fatigue and trouble concentrating. FACT-Lym also asks patients about lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. Score range for the FACT-Lym LymS was 0 - 60, higher score represent less symptoms. Here in below table n signifies evaluable participants for the respective category."|Baseline up to the last patient has completed the 16 weeks of treatment|FAS included all patients assigned to study treatment. The analysis was performed by using last observation carried forward (LOCF) method.|||units on a scale||Inter-Quartile Range|Median
2651662|NCT01660451|Secondary|Progression Free Survival (PFS) Based on Independent Review|PFS was defined as the time (in days) from the date of the first treatment to the date of first observed PD (radiological or clinical, or first AE associated with clinical PD, whichever was earlier) or death due to any cause (if death occurred before progression was documented).|Baseline up to the last patient has completed the 16 weeks of treatment|FAS included all patients assigned to study treatment.|||days||95% Confidence Interval|Median
2651663|NCT01660451|Secondary|DOR Based on Investigator Assessment|"Duration of response (DOR) was defined as the time (in days) from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease [PD], first clinical progression or first adverse event [AE] associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as 'caused by disease progression' except deaths with the reason other or AE not related to disease progression."|Baseline up to the last patient has completed the 16 weeks of treatment|"PPS (for Part A) included all patients with study drug administration that were evaluable for objective tumor response and had no major protocol deviation.~FAS (for Part B) included all patients assigned to study treatment. DOR was only evaluated for patients with at least one tumor response of CR, Cru (only for Part A) or PR."|||days||95% Confidence Interval|Median
2651664|NCT01660451|Secondary|Duration of Response (DOR) Based on Independent Review|"Duration of response (DOR) was defined as the time (in days) from the date of the first observed tumor response of CR or PR (whichever was noted earlier) to first subsequent disease progression (either first progressive disease [PD], first clinical progression or first adverse event [AE] associated with clinical disease progression) or death caused by disease progression, if this death occurred before progression was documented. All deaths were considered as 'caused by disease progression' except deaths with the reason other or AE not related to disease progression."|Baseline up to the last patient has completed the 16 weeks of treatment|"PPS (for Part A) included all patients with study drug administration that were evaluable for objective tumor response and had no major protocol deviation.~FAS (for Part B) included all patients assigned to study treatment. DOR was only evaluated for patients with at least one tumor response of CR, Cru (only for Part A) or PR."|||days||95% Confidence Interval|Median
2651665|NCT01660451|Primary|ORR Based on Investigator Assessment-Part B|Objective response rate was defined as the proportion of participants with a best response rating of CR or PR, based on the International Working Group Revised response Criteria for Malignant Lymphoma, Cheson 2007.|Baseline up to the last patient has completed the 16 weeks of treatment|FAS included all patients assigned to study treatment.|||percentage of participants||95% Confidence Interval|Number
2651666|NCT01660451|Primary|ORR Based on Investigator Assessment-Part A|Objective response rate was defined as the proportion of participants with a best response rating of CR, CRu or PR, based on the Report of an International Workshop to Standardize Response Criteria for non-Hodgkins Lymphomas, Cheson, 1999. For CLL patients Hallek criteria (2008) were used and assessed by investigator.|Baseline up to the last patient has completed the 16 weeks of treatment|Per protocol set included all patients treated with study drug and evaluated for ORR and had no major protocol deviation. Patients who were not evaluable for ORR and discontinued due to a drug-related toxicity, death / progression by clinical judgment before disease was re-evaluated and included.|||percentage of participants||90% Confidence Interval|Number
2651667|NCT01660451|Primary|Objective Response Rate (ORR) Based on Independent Review-Part B|Objective response rate was defined as the proportion of participants with a best response rating of CR or PR, based on the International Working Group Revised response Criteria for Malignant Lymphoma, Cheson 2007.|Baseline up to the last patient has completed the 16 weeks of treatment|FAS included all patients assigned to study treatment.|||percentage of participants||95% Confidence Interval|Number
2651668|NCT01660451|Primary|Objective Response Rate (ORR) Based on Independent Review-Part A|Objective response rate was defined as the proportion of participants with a best response rating of complete response (CR), unconfirmed complete response (CRu) or partial response (PR), based on the Report of an International Workshop to Standardize Response Criteria for non-Hodgkins Lymphomas, Cheson, 1999, as evaluated by the Independent Response Adjudication Committee (IRAC). For chronic lymphocytic leukemia (CLL) patients Hallek criteria (2008) were used and assessed by investigator.|Baseline up to the last patient has completed the 16 weeks of treatment|Per protocol set included all patients treated with study drug and evaluated for ORR and had no major protocol deviation. (In Part A, for CLL patients, there was no independent assessment. Instead, the investigator assessment had been used.)|||percentage of participants||90% Confidence Interval|Number
2651669|NCT01660412|Primary|Perceived Pain Level|Immediately after receiving an injection, subjects will rate their perceived pain level, using a validated measure. Subject was asked to quantify the pain of every injection using a validated scale from 0 through 10, with 0 being no pain and 10 being severe pain that is disabling. The effect of treatment was estimated by taking the difference of the mean buffered and SOC pain scores and a paired t-test was used to test whether the mean difference was significantly different from 0. Perceived pain levels assessed after each injection were averaged for each participant.|immediately after administration (<1 min) of each injection (up to total 5 minutes)||||units on a scale||Standard Deviation|Mean
2651670|NCT01660334|Secondary|Number of Participants With Clinical Response of Cure at the Test-of-Cure(TOC) Visit.|"The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the participants for efficacy analysis.~Clinical response of cure was assessed comprehensively by physicians in the three categories, which were effective, ineffective, and not evaluable, based on the clinical symptoms, imaging diagnosis and endoscopy, fungal tests, and serological tests."|16 weeks|The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2651684|NCT01660230|Secondary|Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||L/h||Standard Deviation|Mean
2651671|NCT01660334|Primary|Number of Participants With Serious Treatment Related Adverse Events.|Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Serious adverse events were defined as those including death, fatal risk, hospitalization or prolongation of hospitalization period, continuous dysfunction, those causing malformation, and serious ones like the above-cited events. Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.|16 weeks|The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.|||participants|||Number
2651672|NCT01660321|Primary|AUC (0-12) for Benzyl Alcohol|Area under the plasma concentration versus time curve (AUC) of benzyl alcohol in Natroba (spinosad) Topical Suspension, 0.9%.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Since the only benzyl alcohol concentrations above Limit of Quantitation (LOQ) (1.0 μg/mL) were for 1 sample each for 4 subjects and 2 non-consecutive samples for 2 subjects, AUC (0-12) was not summarized.|||μg*hr/mL|||Number
2651673|NCT01660321|Primary|Tmax for Benzyl Alcohol|The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for benzyl alcohol.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol|||hours||Full Range|Median
2651674|NCT01660321|Primary|Cmax for Benzyl Alcohol|Peak Plasma Concentration of benzyl alcohol (above Limit of Quantitation (1.0 μg/mL) in Natroba (spinosad) Topical Suspension, 0.9%.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol|||μg/mL||Standard Deviation|Mean
2651675|NCT01660321|Primary|AUC (0-12) for Spinosyn D|Area under the plasma concentration versus time curve (AUC) of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.|||ng* hr/mL|||Number
2651676|NCT01660321|Primary|Tmax for Spinosyn D|The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn D.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.|||hours|||Number
2651677|NCT01660321|Primary|Cmax for Spinosyn D|Peak Plasma Concentration of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.|||ng/mL|||Number
2651678|NCT01660321|Primary|AUC (0-12) for Spinosyn A|Area under the plasma concentration versus time curve (AUC) of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.|||ng*hr/mL|||Number
2651679|NCT01660321|Primary|Tmax for Spinosyn A|The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn A.|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.|||hours|||Number
2651680|NCT01660321|Primary|Cmax for Spinosyn A|Peak Plasma Concentration of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%|Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.|Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or < 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.|||ng/mL|||Number
2651681|NCT01660230|Secondary|Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||mL||Standard Deviation|Mean
2651682|NCT01660230|Secondary|Total Clearance (CL) of 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||mL/h||Standard Deviation|Mean
2651683|NCT01660230|Secondary|Half-life (t1/2) of 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||h||Standard Deviation|Mean
2651751|NCT01659268|Primary|Time to Conclusion of Simulation Scenario (OSCE)|This result present the total time for execution of simulation scenario (OSCE) by the students.|10 minutes||||seconds||Standard Deviation|Mean
2651685|NCT01660230|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||h * ng/mL||Standard Deviation|Mean
2651686|NCT01660230|Secondary|Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis|Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 20 minutes and 1 hour post for doses 1 and 5|All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||ng/mL||Standard Deviation|Mean
2651687|NCT01660230|Secondary|Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||mL||Standard Deviation|Mean
2651688|NCT01660230|Secondary|Total Clearance (CL) of 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||mL/h||Standard Deviation|Mean
2651689|NCT01660230|Secondary|Half-life (t1/2) of 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||h||Standard Deviation|Mean
2651690|NCT01660230|Secondary|Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||L/h||Standard Deviation|Mean
2651691|NCT01660230|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis|Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||h * ng/mL||Standard Deviation|Mean
2651692|NCT01660230|Secondary|Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||ng/mL||Standard Deviation|Mean
2651693|NCT01660230|Secondary|Volume of Distribution (Vz) of 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||mL||Standard Deviation|Mean
2651694|NCT01660230|Secondary|Total Clearance (CL) of 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||mL/h||Standard Deviation|Mean
2651695|NCT01660230|Secondary|Half-life (t1/2) of 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||h||Standard Deviation|Mean
2651696|NCT01660230|Secondary|Elimination Rate Constant (λz) for 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||L/h||Standard Deviation|Mean
2651697|NCT01660230|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||h * ng/mL||Standard Deviation|Mean
2651698|NCT01660230|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to the Final Time With a Concentration ≥ Limit of Quantitation [AUC(0-t)] for 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||h * ng/mL||Standard Deviation|Mean
2651699|NCT01660230|Secondary|Time at Which Cmax is Observed (Tmax) for 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||hour (from start of infusion)||Full Range|Median
2651700|NCT01660230|Secondary|Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Non-compartmental Analysis|Single-dose cohorts|0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post‐dose|All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.|||ng/mL||Standard Deviation|Mean
2651701|NCT01660230|Primary|Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in the Protocol.||Day 6 for multiple-dose cohorts|All 'multiple-dose' subjects who received at least one dose of study treatment.|||participants|||Number
2651702|NCT01660230|Primary|Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol.||Day 4 for single-dose cohorts|All 'single-dose' subjects who received at least one dose of study treatment.|||participants|||Number
2651703|NCT01660191|Secondary|Changes HDL Particle Number and LDL Particle Number|Change in levels will be measured by difference in levels at 12 weeks.|Change from Baseline to 12 Weeks||||particle number||Standard Deviation|Mean
2651704|NCT01660191|Secondary|Changes to Glucose Metabolism - Fructosamine|Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in fructosamine.|Change from Baseline to 12 weeks||||µmol||Standard Deviation|Mean
2651705|NCT01660191|Secondary|Changes in HDL and LDL Size|Change in levels will be measured by difference in levels at 12 weeks|Change from Baseline to 12 Weeks||||nanometre (nm)||Standard Deviation|Mean
2651706|NCT01660191|Secondary|Changes to Glucose Metabolism - HbA1c and Insulin|Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in HbA1c, and insulin.|Change from Baseline to 12 weeks||||percentage change from baseline measure||Standard Deviation|Mean
2651707|NCT01660191|Secondary|Changes in Major Lipid Parameters - VLDL Size|Change in levels will be measured by difference in levels at 12 weeks. Measure based on VLDL size.|Change from Baseline to 12 Weeks||||nanometre (nm)||Standard Deviation|Mean
2651708|NCT01660191|Primary|Changes in Plasma CoQ10 Levels|Change in levels will be measured by taking difference between Baseline and Week 12 measures.|Change from Baseline to 12 Weeks||||μg/g||Standard Deviation|Mean
2651709|NCT01660022|Primary|Piperaquine t1/2|Piperaquine Elimination half-life (t1/2).|Up to 1008 hours post-dose (Day 43)|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.|||hour||Geometric Coefficient of Variation|Geometric Mean
2651710|NCT01660022|Primary|Piperaquine AUC(0-168)|Piperaquine area under the plasma concentration versus time curve to 168 hours post-dose|Up to 1008 hours post-dose (Day 43)|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2651711|NCT01660022|Primary|OZ439 t1/2|OZ439 Elimination half-life|Up to 168 hours post-dose|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.|||hour||Geometric Coefficient of Variation|Geometric Mean
2651712|NCT01660022|Primary|OZ439 AUC(0-168)|Area under the plasma concentration versus time curve to 168 hours post-dose.|Up to 168 hours post-dose|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2651713|NCT01660022|Primary|Piperaquine Cmax|Piperaquine Maximum concentration level|Up to 1008 hours post-dose (Day 43)|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2651714|NCT01660022|Primary|OZ439 Cmax|OZ439 Maximum concentration level|Up to 168 hours post-dose|All randomised subjects who fulfilled the study protocol requirements in terms of study drug intake and PK samplings, with no major deviations that could affect the PK results.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2651723|NCT01659996|Primary|Percentage of Study Participants Achieving Menactra Response for Meningococcal Serogroups A, C, Y, and W-135 Following the Second Menactra Vaccination|"Titers of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay using human complement (hSBA or SBA-HC).~Menactra vaccine response defined as subjects with an hSBA titer <1:8 at baseline achieving an hSBA titer ≥1:8, and subjects with an hSBA titer ≥1:8 at baseline achieving a ≥ 4-fold increase in hSBA titer."|Day 30 post second Menactra vaccination|Antibody titers to the meningococcal serogroups were assessed in the Per-protocol population of the participants in Menactra Vaccine Group and Menactra + Pentacel Vaccine Group.|||Percentage of participants|||Number
2651715|NCT01659996|Primary|Percentage of Participants With Antibody Responses to Diphtheria, Tetanus and Polyribosylribitol Phosphate Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|"Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA), anti-polyribosylribitol phosphate (PRP) antibodies were measured using a Farr-type radioimmunoassay, and anti-diphtheria antibodies were measured by a toxin neutralization test.~The vaccine responses were defined as: Anti-PRP antibody concentrations ≥1.0 μg/mL; Anti-tetanus antibody concentrations ≥1.0 IU/mL and Anti-diphtheria antibody concentrations ≥1.0 IU/mL, respectively, 30 days after vaccination with Pentacel® in participants in Groups 2 and 3."|Day 30 post-vaccination 2|Antibody responses to Diphtheria, Tetanus, and Polyribosylribitol phosphate antigens were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group participants.|||Percentage of Participants|||Number
2651716|NCT01659996|Other Pre-specified|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only, or Menactra Concomitantly With Pentacel Vaccine|Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever > 39.5°C or > 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability - Inconsolable.|Day 0 to Day 7 after the 15 to 18 month vaccination|Solicited reactions were assessed in all subjects who received at least one dose of 15 to 18 month study vaccine, according to the vaccine actually received (Safety Analysis Population).|||Percentage of participants|||Number
2651717|NCT01659996|Primary|Percentage of Participants With Pertussis Vaccine Responses Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|Pertussis antibodies, anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), and Pertactin (PRN) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Pertussis response was defined as: ≥4 × baseline concentration, if the anti-pertussis antibody concentration at baseline is <4 × lower limit of quantification (LLOQ), Or ≥2 × baseline concentration, if the anti-pertussis antibody concentration at baseline is ≥4 × LLOQ|Day 30 post-vaccination 2|Antibody responses to Pertussis vaccine antigens were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group participants.|||Percentage of Participants|||Number
2651718|NCT01659996|Primary|Geometric Mean Concentrations of Pertussis Vaccine Antibodies Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|Pertussis antibodies, anti-Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN) antibodies were measured by enzyme-linked immunosorbent assay (ELISA).|Day 30 post-vaccination 2|Geometric Mean Concentrations (GMC) of Pertussis vaccine antibodies were assessed in the Per-protocol population of participants in Menactra + Pentacel Vaccine Group and Pentacel Vaccine Group.|||Titers||95% Confidence Interval|Geometric Mean
2651719|NCT01659996|Other Pre-specified|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination at 9 Months of Age With Menactra Vaccine.|Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 solicited reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever > 39.5°C or > 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds / meals or refuses most feeds/meals; and Irritability - Inconsolable.|Day 0 to Day 7 after 9-month vaccination|Solicited reactions were assessed in subjects who received at least one dose of study vaccine at 9 month of age, according to the vaccine actually received (Safety Analysis Population).|||Percentage of participants|||Number
2651720|NCT01659996|Other Pre-specified|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With Menactra Only, or Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|Solicited injection-site reactions: Tenderness, Erythema, and Swelling. Solicited Systemic Reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability. Grade 3 solicited reactions defined as: Tenderness - cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever > 39.5°C or > 103.1 °F; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Loss of appetite - Refuses ≥ 3 feeds / meals or refuses most feeds / meals; and Irritability - Inconsolable.|Day 0 to Day 7 after any vaccination|Solicited reactions were assessed in all subjects who received at least one dose of study vaccine, according to the vaccine actually received (Safety Analysis Population).|||Percentage of participants|||Number
2651721|NCT01659996|Other Pre-specified|Geometric Mean Titers of Individual Antibodies to Filamentous Hemagglutinin, Pertactin, Diphtheria, Tetanus and Polio Antigens Following Vaccination With Either Pentacel Only or Menactra Concomitantly With Pentacel Vaccine|Filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), Pertactin (PRN) and anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA); anti-Diphtheria antibodies were measured by a toxin neutralization test.|Day 0 (pre-vaccination) and Day 30 post-vaccination 2|Geometric mean titers of individual vaccine antibodies were assessed in the Per-protocol population of the Menactra + Pentacel Vaccine Group and the Pentacel Vaccine Group participants.|||Titers||95% Confidence Interval|Geometric Mean
2651722|NCT01659996|Other Pre-specified|Geometric Mean Titers of Individual Meningococcal Antibodies in Serum Bactericidal Assay With Human Complement (SBA-HC) Analysis Following Vaccination With Menactra Vaccine|Geometric mean titers (GMTs) of antibodies to serogroups A, C, Y, and W-135 were measured by serum bactericidal assay with human complement (SBA HC) before any vaccination and post-vaccination 2|Day 0 (pre-vaccination) and Day 30 post-vaccination 2|Geometric mean titers of individual antibodies were assessed in the Per-protocol population in the Menactra Vaccine Group and Menactra + Pentacel Vaccine Group participants.|||Titers||95% Confidence Interval|Geometric Mean
2651752|NCT01659268|Secondary|Number of Attempts to Insertion of LMA|Number of attempts for insertion of LMA and obtainment of effective ventilation.|10 minutes (total time of scenario)||||attempts||Standard Deviation|Mean
2651724|NCT01659866|Primary|Number of Participants With Post-biopsy Infection.|To measure and compare the rates of infection following TRUSP in subjects with and without CR-GNB. This measure is number of participants with post-biopsy infection.|30 days post-biopsy|Of the 563 patients who signed consent, 53 were excluded; thus, 510 patients participated in the study. Of these 510, 430 harbored ciprofloxacin-susceptible flora and 80 harbored ciprofloxacin-resistant flora.|||participants|||Number
2651725|NCT01659853|Secondary|Onset of Action|Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application|30 minutes after baseline treatment application on Day 15|A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed. All 70 enrolled subjects were analyzed for efficacy.|||percentage of subjects|||Number
2651726|NCT01659853|Primary|Composite Success|Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period|Hour 6 on Day 15|A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed.|||percentage of subjects|||Number
2651727|NCT01659736|Primary|Remission Status|"Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score < 8 and Clinical Global Impression Improvement score = 1 (very much improved) or 2 (much improved) at 3-month follow-up."|3-month follow-up|3-month follow-up completers|||participants|||Number
2651728|NCT01659736|Primary|Responder Status|Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to 3-month follow-up.|3-month follow-up|3-month follow-up completers|||participants|||Number
2651729|NCT01659736|Primary|Remission Status|"Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score < 8 and Clinical Global Impression Improvement score = 1 (very much improved) or 2 (much improved) at post-treatment."|post-treatment, 6 weeks|Post-treatment completers|||participants|||Number
2651730|NCT01659736|Primary|Responder Status|Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to post-treatment.|Post-treatment, 6 weeks|Post-treatment completers|||participants|||Number
2651731|NCT01659736|Primary|Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up.|Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety.|Pretreatment, Post-treatment (6 weeks after pretreatment), 3-month follow-up|Intent-to-treat sample (n = 25)|||units on a scale||Standard Deviation|Mean
2651732|NCT01659567|Secondary|OR for Impact of Cumulative Doses of Ribavirin on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of ribavirin on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks|Analysis population included all treated participants.|||odds ratio||95% Confidence Interval|Number
2651733|NCT01659567|Secondary|OR for Impact of Cumulative Doses of Pegylated Interferon Alfa-2a on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of pegylated interferon alfa-2a on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks|Analysis population included all treated participants.|||odds ratio||95% Confidence Interval|Number
2651734|NCT01659567|Secondary|OR for Impact of Duration of Treatment After Achieving cEVR on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving cEVR (>11 weeks versus <=11 weeks) on SVR. cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, Weeks 4, 12, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants.|||odds ratio||95% Confidence Interval|Number
2651735|NCT01659567|Secondary|OR for Impact of Duration of Treatment After Achieving RVR on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving RVR (>18 weeks versus <=18 weeks) on SVR. RVR was defined as HCV RNA <=25 IU/mL at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, Week 4, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants.|||odds ratio||95% Confidence Interval|Number
2651736|NCT01659567|Secondary|OR for Impact of Overall Duration of Treatment on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of overall duration of treatment on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants.|||odds ratio||95% Confidence Interval|Number
2651737|NCT01659567|Secondary|OR for Impact of Baseline Viral Load Count on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline viral load count (>800000 IU/mL versus <=800000 IU/mL) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||odds ratio||95% Confidence Interval|Number
2651738|NCT01659567|Secondary|OR for Impact of Baseline Alanine Transaminase (ALT) Level on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline ALT level (>40 international units per liter [IU/L] versus <=40 IU/L) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||odds ratio||95% Confidence Interval|Number
2651739|NCT01659567|Secondary|OR for Impact of Baseline Level of Fibrosis (kPa) on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline level of fibrosis on SVR. Level of fibrosis was measured in terms of kilopascals (kPa) using elastography. kPa score was categorized in 4 groups: 0 to 6.0; 6.1 to 9.9; 10.0 to 14.5; and 14.6 and above. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||odds ratio||95% Confidence Interval|Number
2651740|NCT01659567|Secondary|OR for Impact of Body Weight on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of body weight on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants.|||odds ratio||95% Confidence Interval|Number
2651741|NCT01659567|Secondary|OR for Impact of Gender on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of gender (male versus female) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||odds ratio||95% Confidence Interval|Number
2651742|NCT01659567|Secondary|Odds Ratio (OR) for Impact of Age on SVR|The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of age (greater than [>] 42 years versus <=42 years) on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||odds ratio||95% Confidence Interval|Number
2651743|NCT01659567|Primary|PPV of Complete Early Viral Response (cEVR) on SVR|cEVR was defined as HCV RNA <=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops cEVR would achieve SVR was termed as PPV of cEVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2651744|NCT01659567|Primary|Positive Predictive Value (PPV) of Rapid Viral Response (RVR) on SVR|RVR was defined as HCV RNA less than or equal to (<=) 25 IU/mL at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops RVR would achieve SVR was termed as PPV of RVR on SVR. SVR was defined as HCV RNA level undetectable (<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).|At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2651745|NCT01659567|Primary|Percentage of Participants Achieving Sustained Virological Response (SVR)|SVR was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) level undetectable (less than [<] 15 international units per milliliter [IU/mL]) 24 weeks after completion of the actual treatment period (measured using the COBAS AmpliPrep [CAP]/ COBAS TaqMan [CTM] test). Percentage of participants achieving SVR was reported.|At 24 weeks after end of treatment (EOT) (up to 96 weeks), where EOT = up to 72 weeks|Analysis population included all treated participants. Here, ‘Number of Participants Analyzed’ = participants evaluable for this outcome measure.|||percentage of participants|||Number
2651746|NCT01659554|Secondary|Kaplan-Meier Curves for Patient Overall Survival|Kaplan-Meier analysis will be done using PROC LIFETEST in Statistical Application Software (SAS).|Up to 5 years, survival|zero participants analyzed due to early termination of study||||||
2651747|NCT01659554|Secondary|Time to Serum Ca-125 Nadir and/or CT Response (RECIST Criteria)|Efficacy of surgical resection with HIPEC combined with repeated intraperitoneal chemotherapy: The end point will be the objective response rate and progression-free survival as well as the overall survival, if feasible. We will analyze the time to serum Ca 125 nadir and/or CT response based on Recist criteria.|Up to 5 years (survival)|zero participants analyzed due to early termination of study||||||
2651748|NCT01659554|Primary|Toxicity Rating Based on NCI Common Toxicity Criteria|Patients will be rated for toxicity prior to each cycle using the NCI Common Toxicity Criteria (NCICTC; see the CTCAE, Version 4.0).|Up to 5 years|zero participants analyzed due to early termination of study||||||
2651749|NCT01659554|Primary|Adverse Event Rate and/or Laboratory Changes|The adverse event rate and laboratory changes will be used to investigate the safety of surgical debulking with heated intraperitoneal chemotherapy (HIPEC) combined with repeated intraperitoneal chemotherapy.|5 years|zero participants analyzed due to early termination of study||||||
2651753|NCT01659268|Secondary|Time for Acquisition of First Effective Ventilation, Adequate Tidal Volume and Stabilization of Patient.|"Time of achievement to first effective ventilation and tidal volume (adequate chest expansion).~Stabilization of mannequin parameters (spO2 e HR)."|10 minutes (600 sec)||||seconds||Standard Deviation|Mean
2651754|NCT01659268|Primary|Scores in Pre and Post-test, Number of Participants Successfully Completing the Overall Performance Simulated Scenario(OSCE).|"Score obtained in pre and post-test written, time to obtain the first effective ventilation (chest expansion through adequate ventilation on the mannequin), number of attempts to insert the LMA in the simulation scenario (OSCE).~Pre-test: 20 questions with score of 0.5 points each - minimum score=0 points and maximum score=10 points. Score 5-7 points was considered satisfactory; scores between 7-8 points was considered good performance; above 8 points excellent.~Post-test: 20 questions with score of 0.5 points each - minimum score=0 points and maximum score=10 points. Score 5-7 points was considered satisfactory; scores between 7-8 points was considered good performance; above 8 points excellent.~OSCE: instrument with total of 10 skills - each skill was subdivided in 4-5 activities (0.2-0.25 points each) - poor performance was score < 5.0; satisfactory performance 5.0-7.0; good 7.0-8.5 and excellent above 8.5 points."|Pretest: 40 minutes; Post-test: 40 minutes; OSCE: 10 minutes|The number of participants result of students that signed up in the workshop.|||units on a scale||Standard Deviation|Mean
2651755|NCT01659125|Primary|Responder Status|Participants who experienced a clinically significant change in Y-BOCS score defined as posttreatment YBOCS score that (a) has decreased by a reliable level (at least 1.96 times the standard deviation of that measure, taking into account the reliability of the measure itself; in this case, a decrease of 5 points or more), and (b) is within the nonclinical range of scores (in this case, a score of 13 or below).|Week 17 (post-treatment) and 6-month follow-up|Results are reported at each time-point for the intent-to-treat sample of participants who initiated treatment (n = 24).|||participants|||Number
2651756|NCT01659125|Primary|Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)|The Y-BOCS is a semi-structured interview that assesses severity of obsessions and compulsions. The total score is reported here and ranges from 0 to 40 with higher scores indicating more severe OCD symptoms.|Baseline (pretreatment), 17-weeks (posttreatment), and 6 month-follow-up|Results are reported at each time-point for the intent-to-treat sample of participants who initiated treatment (n = 24).|||units on a scale||Standard Deviation|Mean
2651757|NCT01659021|Secondary|Complete Response Rate|Complete response rate was defined as the percentage of participants who achieve a complete response and maintain their response for at least 8 weeks (with a 1-week window).|Randomization to End of Study (up to 60 months)|Participants in the ITT Analysis Set were analyzed.|||percentage of participants|||Number
2651758|NCT01659021|Secondary|Progression-Free Survival in Subgroup of Participants With Chromosome 17p Deletion and/or TP53 Mutation|Progression-free survival in subgroup of participants with chromosome 17p deletion and/or TP53 mutation was analyzed using KM estimates.|Randomization to End of Study (up to 60 months)|Participants in the ITT Analysis Set with chromosome 17p deletion and/or TP53 mutation were analyzed.|||months||95% Confidence Interval|Median
2651759|NCT01659021|Secondary|Overall Survival|Overall survival was defined as the interval from randomization to death from any cause. Overall survival was analyzed using KM estimates.|Randomization to Last Long-Term Follow-Up Visit (up to maximum of 5 years)|Participants in the ITT Analysis Set were analyzed.|||months||95% Confidence Interval|Median
2651760|NCT01659021|Secondary|Lymph Node Response Rate|Lymph node response rate was defined as the proportion of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lymph nodes.|Randomization to End of Study (up to 60 months)|Participants in the ITT Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2651761|NCT01659021|Secondary|Overall Response Rate|"Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.~Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.~Partial response was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors. Overall response rate was analyzed using KM estimates."|Randomization to End of Study (up to 60 months)|Participants in the ITT Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2651762|NCT01659021|Primary|Progression-Free Survival|Progression-free survival (PFS) was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL. PFS was analyzed using Kaplan-Meier (KM) estimates.|Randomization to End of Study (up to 60 months)|Intent-to-Treat (ITT) Analysis Set included participants who were randomized in the study regardless of whether they received any study drug(s), or received a different regimen from that to which they were randomized. Treatment assignment was designated according to randomization.|||months||95% Confidence Interval|Median
2651763|NCT01658943|Other Pre-specified|Objective Response Rate|Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.|Up to 3 years|All eligible and analyzable patients with measurable disease.|||participants|||Number
2651764|NCT01658943|Other Pre-specified|Progression-free Survival|From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.|Up to 3 years|Eligible and analyzable patients.|||months||95% Confidence Interval|Median
2651765|NCT01658943|Primary|Overall Survival|From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 3 years|Eligible and analyzable patients.|||months||95% Confidence Interval|Median
2651769|NCT01658904|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|8 months and 15 days|Analysis of dose limiting toxicities (DLTs) was planned but not performed due to study termination; this Outcome Measure captures any events that occurred.|||participants|||Number
2651770|NCT01658904|Primary|Engraftment Failure Transplant Related Mortality|Engraftment failure is defined as the failure to achieve neutrophil engraftment by day 21; defined from day 0, day of autologous hematopoietic cell transplantation (AHCT), as the first of three consecutive days on which the patient's absolute neutrophil count is greater than 0.5x10(9)/l following the nadir. Transplant related mortality is defined as any subject who dies in the first 100 days post-AHCT of any non-relapse related cause.|up to day 100||||participants|||Number
2651771|NCT01658839|Primary|Half-life (t½)|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). T½ was calculated for each participant with at least 3 quantifiable time points.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).|||hours||Standard Deviation|Mean
2651772|NCT01658839|Primary|Area Under the Analyte Plasma Concentration-time Curve Over the Dosing Interval (Inf)[AUC(0-∞)]|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). AUC(0-∞) was calculated for each participant with at least 3 quantifiable time points.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).|||ng*hr/mL||Standard Deviation|Mean
2651773|NCT01658839|Primary|Area Under the Analyte Plasma Concentration-time Curve to the Last Quantifiable Sampling Time Point [AUC(0-tlast)]|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). AUC(0-tlast) was calculated for each participant with at least 2 quantifiable time points.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).|||ng*hr/mL||Standard Deviation|Mean
2651774|NCT01658839|Primary|Time to Last Measurable Concentration (Tlast)|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Tlast was calculated for each participant with at least 1 quantifiable time point.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).|||hours||Standard Deviation|Mean
2651775|NCT01658839|Primary|Time to Reach Cmax (Tmax)|Analyte plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Tmax was calculated for each participant with at least 1 quantifiable time point.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).|||hours||Standard Deviation|Mean
2651776|NCT01658839|Primary|Maximum Observed Travoprost Free Acid Plasma Concentration (Cmax)|Travoprost free acid plasma concentrations at each collection time point (predose, 10, 20, 40, 80 minutes postdose) were quantitated using a high performance liquid chromatography/tandem mass spectrometry method (HPLC/MS/MS). Cmax was calculated for each participant with at least 1 quantifiable time point.|Day 7, Up to 80 minutes postdose|This analysis group includes all participants who received at least 2 doses of the study drug, satisfied protocol required criteria relevant to the assessments of PK parameters, had at least 1 postdose blood draw, and for whom adequate PK data were collected (without collection or analytical deviations that would affect the integrity of the data).|||ng/mL||Standard Deviation|Mean
2651777|NCT01658813|Secondary|Median Survival|Median survival was measured from date of entry on study until date of death|up to 2 years|Data was not collected||||||
2651778|NCT01658813|Secondary|Median Duration of Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by radiographic imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up tp 2 years|Data was not collected||||||
2651779|NCT01658813|Secondary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by radiographic imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 2 years|Data was not collected||||||
2651780|NCT01658813|Secondary|Number of Responses|Radiographic studies to evaluate for response were done at 8 weeks (after 1 cycle). Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 2 years.|Data was not collected||||||
2652507|NCT01651780|Secondary|Acute Kidney Injury|The percentage of participants reporting acute kidney injury is presented.|at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up|Participants in the ITT population.|||percentage of participants|||Number
2651781|NCT01658813|Primary|Progression Free Survival|Progression Free Survival (PFS) was calculated as the time (months) from date of the start of treatment to the date of first observed disease progression (per standard Response Evaluation Criteria In Solid Tumors [RECIST] or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.|Assessed up to 2 years|Data was not collected||||||
2651782|NCT01658735|Secondary|Change From Baseline in VAS Pain Score at 12 Weeks|"Measure of the change in visual analogue scale (VAS) after twelve weeks of treatment compared with baseline VAS measure.~The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10). Higher scores represent higher reported pain."|Week 12||||units on a scale||95% Confidence Interval|Mean
2651783|NCT01658735|Secondary|Change From Baseline in VAS Pain Score at 8 Weeks|"Measure of the change in visual analogue scale (VAS) after eight weeks of treatment compared with baseline VAS measure.~The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10). Higher scores represent higher reported pain."|Week 8||||units on a scale||95% Confidence Interval|Mean
2651784|NCT01658735|Secondary|Change From Baseline in VAS Pain Score at 4 Weeks|"Measure of the change in visual analogue scale (VAS) after four weeks of treatment compared with baseline VAS measure.~The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10). Higher scores represent higher reported pain."|Week 4||||units on a scale||95% Confidence Interval|Mean
2651785|NCT01658735|Secondary|Change From Baseline in VAS Pain Score at 1 Week|"Measure of the change in visual analogue scale (VAS) after one week of treatment compared with baseline VAS measure.~The VAS is a commonly used continuous scale measure for low back pain. For pain intensity, the scale is anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10). Higher scores represent higher reported pain."|Week 1||||units on a scale||95% Confidence Interval|Mean
2651786|NCT01658735|Primary|Change From Baseline in Oswestry Disability Index at 12 Weeks|"Measure of the change in Oswestry Disability Index (ODI) after twelve weeks of treatment compared with baseline measure.~The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability."|Week 12||||units on a scale||95% Confidence Interval|Mean
2651787|NCT01658735|Primary|Change From Baseline in Oswestry Disability Index at 8 Weeks|"Measure of the change in Oswestry Disability Index (ODI) after eight weeks of treatment compared with baseline measure.~The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability."|Week 8||||units on a scale||95% Confidence Interval|Mean
2651788|NCT01658735|Primary|Change From Baseline in Oswestry Disability Index at 4 Weeks|"Measure of the change in Oswestry Disability Index (ODI) after four weeks of treatment compared with baseline measure.~The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability."|Week 4||||units on a scale||95% Confidence Interval|Mean
2651789|NCT01658735|Primary|Change From Baseline in Oswestry Disability Index at 1 Week|"Measure of the change in Oswestry Disability Index (ODI) after one week of treatment compared with baseline measure.~The ODI is a commonly used outcome-measure questionnaire for low back pain. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage, with a possible range of 0 to 100. Higher scores represent higher reported disability."|1 week||||units on a scale||95% Confidence Interval|Mean
2651790|NCT01658657|Primary|Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic|At each study visit (approximately every 30 days), participants' BP will be checked. If BP is controlled (<140mmHG systolic and <90mmHG diastolic), then current medication will continue. If BP is uncontrolled, medication will be revised every 30 days (up to 120) until BP control is achieved.|4 months|6 participants withdrawn before study completion|||participants|||Number
2651804|NCT01658436|Secondary|Stage 1 - Disease Control Rate|Disease control rate was defined as the proportion of patients with a best overall response of Complete Response, Partial response, or Stable disease, based on the investigator's assessment per RECIST version 1.1. Based on futility analysis conducted at the end of stage 1, stage 2 was not initiated.|Baseline, every 8 weeks up to 31 months|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of study treatment (Stage 1). This set was known as ‘Analysis Set Stage 1’ (AS1).|||Percentage of participants||95% Confidence Interval|Number
2651829|NCT01658150|Secondary|Beck Scale for Suicidal Ideation (SSI)|a 21-question multiple choice, self-report inventory that is used for measuring the severity of suicidal ideation. Scoring is from a 0 (not at all) to 3 (severe) with a total score range of 0-63. Higher total scores indicate more severe suicidal ideation symptoms.|up to 4 weeks|Data not collected.||||||
2651791|NCT01658579|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to Week 16|Safety population: all randomized participants who were exposed to at least one dose, regardless of amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.|||percentage of participants|||Number
2651792|NCT01658579|Secondary|Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16||Baseline, Week 8, 16|Modified Intent-to-Treat population. Here n = participants with basal insulin dose assessment at specified time-point. Missing data imputed using LOCF.|||U/kg||Standard Deviation|Mean
2651793|NCT01658579|Secondary|Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16|Change in average of 7-point SMPG. 7-point SMPG was assessed starting with a measurement at before breakfast and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; at bedtime.|Baseline, Week 8, 16|Modified Intent-to-Treat population. Number of participants analyzed = participants with baseline, Week 8 and/or 16 7-point SMPG assessment, n = participants with 7-point SMPG assessment at specified time. Missing data imputed using LOCF.|||mmol/L||Standard Deviation|Mean
2651794|NCT01658579|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16||Baseline, Week 8, 16|Modified Intent-to-Treat population. Number of participants analyzed = participants with baseline, Week 8 and/or 16 FPG assessment, n = participants with FPG assessment at specified time. Missing data imputed using LOCF.|||mmol/L||Standard Deviation|Mean
2651795|NCT01658579|Secondary|Change in HbA1c From Baseline to Week 8 and 16||Baseline, Week 8, 16|Modified Intent-to-Treat population: randomized participants who received at least 1 dose; had baseline, at least 1 post-baseline efficacy assessment; irrespective of compliance. Number of participants analyzed = participants with baseline, Week 8 and/or 16 HbA1c assessment, n = participants with HbA1c assessment at specified time. LOCF applied.|||percentage of hemoglobin||Standard Deviation|Mean
2651796|NCT01658579|Secondary|Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL]) in the Last Four Hours of Each Dosing Interval at Weeks 7 and 8 in Period A and Weeks 15 and 16 in Period B|Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.|Weeks 7-8 in Period A and Weeks 15-16 in Period B|CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment, and n = participants with assessment at specified time-point.|||percentage of time||Standard Deviation|Mean
2651797|NCT01658579|Secondary|Evaluation of Diurnal Glucose Exposure, Variability, and Stability|The diurnal glucose exposure is measured as the average diurnal glucose concentration, diurnal glucose variability is measured by interquartile range (IQR), that is, average distance between the 25th and the 75th point-wise percentiles and diurnal glucose stability is assessed in terms of the mean absolute rate of change (mmol/l), that is, the area under the absolute rate of change of the median curve (based on the median point values between two adjacent hourly basket intervals), divided by the length of the assessment interval.|Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)|CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment. Missing data imputed using LOCF.|||mmol/L||Standard Error|Least Squares Mean
2651798|NCT01658579|Secondary|Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL])|Percentage of time with glucose below the lower limit of glycemic range (<4.4 mmol/L) was assessed by the total time below the lower limit of glycemic range divided by the length of the assessment interval.|Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)|CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment. Missing data imputed using LOCF.|||percentage of time||Standard Error|Least Squares Mean
2651799|NCT01658579|Secondary|Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])|Percentage of time with glucose above the upper limit of glycemic range (>7.8 mmol/L) was assessed by the total time above the upper limit of glycemic range divided by the length of the assessment interval.|Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)|CGM population. Number of participants analyzed = participants with baseline, Weeks 7, 8 (Period A), and/or Weeks 15, 16 (Period B) CGM assessment. Missing data imputed using last observation carried forward (LOCF).|||percentage of time||Standard Error|Least Squares Mean
2651800|NCT01658579|Primary|Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])|Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.|Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)|Continuous glucose monitoring (CGM) population: All participants who received at least 1 dose, had evaluable post-baseline CGM data, irrespective of compliance. Number of participants analyzed = participants with baseline, Weeks 7-8 (Period A) and/or Weeks 15-16 (Period B) CGM assessment. Missing data imputed using last observation carried forward.|||percentage of time||Standard Error|Least Squares Mean
2651801|NCT01658514|Primary|Correlation of Placebo-adjusted Change From Pre-dose Value in Lactate Versus Metformin Concentration|To determine the exposure-response relationship of metformin and plasma lactate concentrations|from the time of dosing (0 h) to 24 hours postdose|PD Evaluable Population|||R²|||Number
2652508|NCT01651780|Secondary|Transient Ischemic Attack|The percentage of participants reporting transient ischemic attack is presented.|at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)|Participants in the ITT population.|||percentage of participants|||Number
2651805|NCT01658436|Secondary|Stage 1- Overall Response Rate (ORR)|Overall Response rate was defined as the proportion of patients with a best overall response of complete response or partial response, based on investigator's assessment as per RECIST criteria version 1.1. Based on futility analysis conducted at the end of stage 1, stage 2 was not initiated.|Baseline, every 8 weeks up to 31 months|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of study treatment (Stage 1). This set was known as ‘Analysis Set Stage 1’ (AS1).|||Percentage of participants|||Number
2651806|NCT01658436|Primary|Stage 1 - Progression Free Survival (PFS) Rate Analysis at 16 Weeks as Per Local Radiology Review|"PFS rate at 16 weeks was defined as a binary variable. Patients were considered as 'progression free' after 16 weeks if they had an overall lesion response of complete response (CR) partial response ('PR) or stable disease (SD)' and progressed if they had an overall lesion response of 'Progressive disease (PD) at the scan which occurred on day 105 after start of treatment, or later. Patients whose 16 weeks tumor assessment was unknown, missing or outside the window was not considered as 'progression free' and was considered a failure and counted only in the denominator for the estimation of the 16 week progression free rate."|16 weeks after the first BEZ235 administration.|The Full Analysis Set (FAS) comprised of all patients who received at least one dose of study treatment (Stage 1). This set was known as ‘Analysis Set Stage 1’ (AS1).|||Percentage of participants||95% Confidence Interval|Number
2651807|NCT01658228|Other Pre-specified|FC-SRT||Week 0 Screening|||||||
2651808|NCT01658228|Other Pre-specified|WMS-R Logical Memory||Week 0 Screening|||||||
2651809|NCT01658228|Other Pre-specified|MRI Scan|Images will be obtained using a GE Signa 3 Tesla whole body scanner. T1-weighted sagittal fspgr and T2 FLAIR are the pulse sequences used in order to obtain the MRI images.|Within 1 month of Screen Visit (Week 0)|||||||
2651810|NCT01658228|Other Pre-specified|University of Pennsylvania Smell Identification Test (UPSIT)|"The subject will scratch and sniff 40 common odorants embedded in microcapsules on a separate page. The subject will choose the answer from a 4-item multiple choice list. Scores will range from 0-40."|Screen (Week 0)|||||||
2651811|NCT01658228|Other Pre-specified|Apolipoprotein E Genotype|Using a standard protocol, DNA is amplified by the polymerase chase reaction (PCR). The genotypes are determined blind to subject status (patient or control) by the sizes of DNA fragments present.|Week 2|||||||
2651812|NCT01658228|Other Pre-specified|Boston Naming||Screen (Week 0), Week 16, Week 40, Week 64, Week 78|||||||
2651813|NCT01658228|Other Pre-specified|COWAT||Screen (Week 0), Week 16, Week 40, Week 64, Week 78|||||||
2651814|NCT01658228|Other Pre-specified|WAIS-III Block Design Subtest||Screen (Week 0), Week 16, Week 40, Week 64, Week 78|||||||
2651815|NCT01658228|Other Pre-specified|WAIS-III Digit Symbol Subtest||Screen (Week 0), Week 16, Week 40, Week 64, Week 78|||||||
2651816|NCT01658228|Other Pre-specified|Stroop||Screen (Week 0), Week 16, Week 40, Week 64, Week 78|||||||
2651817|NCT01658228|Other Pre-specified|Trails A and B|Parts A and B are composed of 25 circles. Patients are asked to scan the entire page and identify the next number or letter in a sequence.|Screen (Week 0), Week 16, Week 40, Week 64, Week 78|||||||
2651818|NCT01658228|Other Pre-specified|WMS-III Visual Reproduction Subtest||Screen (Week 0), Week 16, Week 40, Week 64, Week 78|||||||
2651819|NCT01658228|Secondary|Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog)|The modified ADAS-Cog is a cognitive battery that assesses learning, memory, language production, language comprehension, constructional praxis, ideational praxis, and orientation. Subjects' scores represent the total number of errors made throughout the various tasks. The total number of possible errors is between 0-85.|Week 16||||number of errors on a scale from 0-85||Standard Deviation|Mean
2651820|NCT01658228|Primary|Selective Reminding Test (SRT) Delayed Recall|The 12-item, 6-trial SRT is a memory measure used to assess verbal list learning and memory. The total number of words learned over six trials (total immediate recall) and delayed recall (after a 15-minute delay) was obtained.|Week 16||||Words||Standard Deviation|Mean
2651821|NCT01658228|Primary|Selective Reminding Test (SRT) Total Recall|The 12-item, 6-trial SRT is a memory measure used to assess verbal list learning and memory. The total number of words learned over six trials (total immediate recall) was obtained.|Week 16||||Words||Standard Deviation|Mean
2651822|NCT01658150|Secondary|Clinician Administered Rating Scale for Mania (CARS-M)|Mean change of symptoms of mania throughout the study. CARS-M contains 14 items rated from 0 (absent) to 5 (present) and one item scored 0 to 4, with total range from 0 to 74, where higher score indicates manic symptoms.|up to 4 weeks||||score on a scale||Standard Deviation|Mean
2651823|NCT01658150|Secondary|Clinical Global Impression Scale (CGI)|Mean change of clinical impression of severity of psychiatric illness throughout the study. CGI consists of one item, defined by severity of illness. It is rated on a 7-point scale, ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients), with a total range score of 1-7, where higher score indicates severity of illness.|up to 4 weeks||||score on a scale||Standard Deviation|Mean
2651824|NCT01658150|Secondary|Hamilton Rating Scale for Depression (HRSD)|Mean change of symptoms of depression throughout the study. HRSD consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe), with a total score range of 0-56, where higher score indicates more depressive symptoms|up to 4 weeks||||score on a scale||Standard Deviation|Mean
2651825|NCT01658150|Secondary|Scale for the Assessment of Negative Symptoms (SANS)|Mean change of negative symptoms throughout the study. SANS consists of 22 items, each defined by a series of symptoms. Each item is rated on a 6-point scale, ranging from 0 (no presence) to 5 (severe presence), with a total range of 0-110, where higher scores indicate negative symptoms.|up to 4 weeks||||score on a scale||Standard Deviation|Mean
2651826|NCT01658150|Secondary|Brief Psychiatric Rating Scale (BPRS)|Mean change for positive symptoms throughout the study. BPRS consists of 18 items, each defined by a series of symptoms. Each item is rated on a 7-point scale, ranging from 1 (not observed) to 7 (very severe), with a total score range from 18-126, where higher scores indicate psychiatric symptoms.|up to 4 weeks||||score on a scale||Standard Deviation|Mean
2651827|NCT01658150|Secondary|Number of Participants With a Confirmed SCID-IV|Number of participants with confirm diagnosis for inclusion into study using the Structured Clinical Interview for the DSM-IV (SCID-IV)|baseline||||Participants|||Count of Participants
2651830|NCT01658150|Secondary|Modified Simpson Angus Scale (MSAS)|Mean change for drug-induced disordered movement throughout the study. The MSAS is a physician-administered scale of abnormal drug-induced movements. MSAS consists of 6 items, each defined by a series of movements. Each item is rated on a 5-point scale, ranging form 0 (not observed) to 4 (most severe), with a total range of 0-24, where higher scores indicate drug-induced disordered movement.|baseline and week 4||||score on a scale||Standard Deviation|Mean
2651831|NCT01658150|Secondary|Abnormal Involuntary Movement Scale (AIMS)|Mean change for abnormal involuntary movements throughout the study. The AIMS is a physician-administered scale of abnormal involuntary movements. AIMS consists of 10 items, each defined by a series of movements. Each item is rated on a 5-point scale, ranging from 0 (not observed) to 4 (severe), with a total score range from 0-40, where higher scores indicate abnormal involuntary movements.|baseline and Week 4||||score on a scale||Standard Deviation|Mean
2651832|NCT01658150|Secondary|Number of Participants With Normal Complete Blood Count (CBC)|Number of participants with normal CBC to confirm inclusion into study at baseline and week 4|baseline and week 4||||Participants|||Count of Participants
2651833|NCT01658150|Secondary|Number of Participants With Normal Chemistry Panel|Number of participants with normal chemistry panel to confirm inclusion into study at baseline and week|baseline and week 4||||Participants|||Count of Participants
2651834|NCT01658150|Secondary|Number of Participants With Normal ECG|Number of participants with normal ECG readings to confirm inclusion into study and compared at week 4 to baseline|baseline and week 4||||Participants|||Count of Participants
2651835|NCT01658150|Secondary|Mean Change in PRISE Adverse Event Checklist Score|The PRISE is a physician-administered checklist of adverse events. PRISE contains 33 items, each defined by an adverse event. Each item is rated on a 3-point scale, ranging from 0 (not present) to 2 (distressing), with a total score range from 0-66, where higher scores indicate more adverse events. Mean change for adverse events at week 4 as compared to baseline|up to 4 weeks||||score on a scale||Standard Deviation|Mean
2651836|NCT01658150|Primary|Quality of Life (QoL) Scale|The QoL is a measure of the perceived satisfaction in an individual's daily life. This 16-item self-report measure is rated on a 7-point scale, ranging from 1 (terrible) to 7 (delighted), with a total score range from 16-112, where higher scores indicate higher satisfaction with daily life.|baseline and Week 4||||score on a scale||Standard Deviation|Mean
2651837|NCT01658150|Primary|UPSA Communication Score|UCSD Performance Skills Assessment (UPSA) - The UPSA is performance-based measure of real-world daily functioning abilities. Participants receive scores for the communication subscale (range = 0-20), with higher score indicating better neurocognitive functioning|baseline and week 4||||score on a scale||Standard Deviation|Mean
2651838|NCT01658150|Primary|MATRICS Consensus Cognitive Battery (MCCB) Change in Neurocognitive/Functional Measures|MATRICS Consensus Cognitive Battery (MCCB) as measure of Neurocognitive/Functional Measures is a standardized battery designed to measure cognitive functioning in people with schizophrenia. The MCCB is represented as a composite T score. A t score is a type of standard score computed by multiplying a z-score (how many standard deviations an element is from the mean) by 10 and adding 50.|baseline and week 4||||z-score||Standard Deviation|Mean
2651839|NCT01658072|Primary|Time Until Patient is Ready for Discharge|"readiness for discharge to home or to a rehabilitation facility (compared to the HSS standard regimen of epidural analgesia) after total hip arthroplasty."|Length of Hospital Stay, an expected average of 3 days||||days||Standard Deviation|Mean
2651840|NCT01658059|Primary|Reducing Children's Anxiety|Measuring levels of salivary cortisol and salivary α-amylase levels before dental treatment and after dental treatment .|Each dental apointment, aproximatly 30 minutes on the average||||ng/ml||Standard Deviation|Mean
2651841|NCT01658020|Secondary|Change in CAT Scores|"The outcome measurement is Change in CAT scores for clinical populations at Test of cure visit.~CAT score means that COPD Assessment Test was used as a tool to assess the effects of COPD on physical, mental status and daily life.~CAT is consisted of 8 items in total and each question item was scored from 0 point to 5 point.~The scores of each question item were summed into the total score, which had values between 0 and 40."|10 days|Per protocol population|||scores on a scale||Standard Deviation|Mean
2651842|NCT01658020|Secondary|Change in EXACT-PRO Score|"The outcome measurement is Change in EXACT-PRO score for clinical populations at Test of cure visit.~EXACT-PRO means that the questionnaires for Exacerbation of Chronic Pulmonary Disease Tool-Patient Reported Outcome of United BioSource Corporation(UBC) of USA that had been standardized, equipped with reliability and feasibility applicable to various COPD patients groups were used in order to quantitate frequency, severity and duration of acute exacerbation as a tool to measure acute exacerbation of COPD.~EXACT-PRO is consisted of 14 questionnaire items were classified into 3 domains, Respiratory Distress Domain, Cough/Sputum Domain, and Chest Symptoms Domain. The Scores of each domain were to be summed into the domain raw summed score or converted into EXACT domain score according to the conversion table. The total score had value in the range from 0 to 100 and higher the value was, severer the respiratory symptoms were in evaluation."|10 days|Per protocol population|||scores on a scale||Standard Deviation|Mean
2651843|NCT01658020|Secondary|Microbiological Response Rate|"Microbiological response rate in the microbiological per protocol(PP) population.~Microbiological rate were discriminated for the pathogens isolated from the respiratory secretion samples of subjects."|10days||||Percentage of participants||95% Confidence Interval|Number
2651844|NCT01658020|Secondary|Clinical Cure Rate in the Microbiological Per Protocol(PP) Population|"Clinical response corresponding clinical cure in the microbiological per-protocol population.~Microbiological responses were discriminated for the pathogens isolated from the respiratory secretion samples of subjects."|10days||||Percentage of participants||95% Confidence Interval|Number
2651845|NCT01658020|Secondary|Clinical Response in the Clinical Population|Clinical response corresponding clinical cure at End of Study visit. Based on the clinical outcomes, the results of assessment were classified into Clinical Cure, Clinical Failure, Relapse and Indeterminate.|36days|Per protocol population|||percentage of participants||95% Confidence Interval|Number
2651846|NCT01658020|Primary|Clinical Response in the Clinical Populations|Clinical response corresponding clinical cure at Test of Cure visit. Based on the clinical outcomes, the results of assessment were classified into Clinical Cure, Clinical Failure, Relapse and Indeterminate.|10days|Per protocol population|||percentage of participants||95% Confidence Interval|Number
2651847|NCT01657903|Other Pre-specified|SMH Recovery of Enamel Specimens Post 2 Hours of Treatment Exposure|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1- R)/ (E1-B)]*100. A higher percentage values indicate a better outcome.|Baseline, 2 hours post treatment in each treatment period|PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis.|||Percentage SMH||Standard Error|Least Squares Mean
2651848|NCT01657903|Other Pre-specified|RER of Enamel Specimens Post 2 Hours of Treatment Exposure|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.|Baseline, 2 hours post treatment in each treatment period|PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.|||% RER||Standard Error|Least Squares Mean
2651849|NCT01657903|Primary|Surface Microhardness (SMH) Recovery of Enamel Specimens Post 4 Hours of Treatment Exposure|SMH test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1- R)/ (E1-B)]*100. A higher percentage values indicate a better outcome.|Baseline, 4 hours post treatment in each treatment period|PP population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.|||Percentage SMH||Standard Error|Least Squares Mean
2651850|NCT01657903|Primary|Relative Erosion Resistance (RER) of Enamel Specimens Post 4 Hours of Treatment Exposure|Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine RER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent RER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative RER, better is treatment regimen in imparting resistance to enamel.|Baseline, 4 hours post treatment in each treatment period|Per protocol (PP) population: All randomized subjects who had at least one assessment of efficacy and considered unaffected by major protocol deviations, were included in analysis. Due to drop outs, there was difference in number of participants analyzed.|||Percentage RER||Standard Error|Least Squares Mean
2651851|NCT01657877|Primary|Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice.|Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.|Baseline to 21 days|Per protocol (PP) population: The per protocol (PP) population was defined as those subjects in the intention to treat population who did not have protocol violations leading to exclusion of all efficacy data from analyses. Missing data was not imputed.|||Percentage SMHR||Standard Error|Mean
2651852|NCT01657877|Secondary|Enamel Fluoride Uptake (EFU)|Change to EFU was determine using a microdrill enamel biopsy of the in situ enamel specimens.|Baseline to 21 days|PP population: all randomized participants in the ITT population who had no protocol violations leading to exclusion of all efficacy data from analyses. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group.|||ppm EFU||Standard Error|Mean
2651853|NCT01657877|Secondary|Percentage (%) Change in SMH Following 21 Days of Twice Daily Treatment With 500 Ppm Fluoride as SMFP and 0 % CSP Dentifrice, 0 Ppm Fluoride and 0% CSP, and 0 Ppm Fluoride and 5 % CSP.|Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.|Baseline to 21 days|PP population:all randomized participants in the ITT population who had no protocol violations leading to exclusion of all efficacy data from analyses.|||Percentage SMHR||Standard Error|Mean
2651854|NCT01657799|Secondary|Time to Clinical Brain Metastasis Progression|Time to clinical brain metastases progression was defined as the number of days from randomization to the date of the first experience of clinical brain metastases progression, as assessed by a team of neuro-oncology experts (Event Review Board). All events of clinical brain metastasis progression were included, regardless of whether the event occurred while the participant was still receiving study treatment or had previously discontinued study treatment. If a participant did not have an event of clinical brain metastases progression, their data were censored at the date of the last available clinical disease progression assessment. Time to clinical brain metastasis progression was estimated for each treatment group using Kaplan-Meier methodology.|From randomization up to 24 months|All randomized participants|||days||95% Confidence Interval|Median
2651884|NCT01657370|Primary|Dry Blood Spot (DBS) MK-1602 Concentration at 2 Hours Post-Dose on Migraine Treatment Day|The participant collected blood by fingerstick on a card. The card was sent to a laboratory and the concentration of MK-1602 determined using the dried blood spot (DBS) assay.|2 hours post dose 1|Participants from the Pharmacokinetic Analysis Population, all participant who received treatment, with data available for analysis.|||nanomolar (nM)||Geometric Coefficient of Variation|Geometric Mean
2651855|NCT01657799|Secondary|Time to Intracranial Progression (Radiographic)|Time to intracranial progression (radiographic) was defined as the number of days from the date of randomization to the date of the first intracranial progression, as determined by brain scan imaging (magnetic resonance image [MRI]/ computed tomography [CT] scan) by a central imaging vendor. All confirmed events of intracranial progression were included, regardless of whether the event occurred while the participant was still taking study treatment or had previously discontinued study treatment. If the participant did not have a confirmed event of intracranial progression, their data were censored at the date of the last available intracranial progression assessment. Time to intracranial progression (radiographic) was estimated for each treatment group using Kaplan-Meier methodology.|From randomization up to 24 months|All randomized participants|||days||95% Confidence Interval|Median
2651856|NCT01657799|Secondary|Best Tumor Response Rate|"Best tumor response rate was calculated as the percentage of participants with a complete response or partial response, as determined by brain scan imaging (magnetic resonance image or computed tomography) by a central imaging vendor. Response was assessed according to the modified bidimensional criteria:~Complete response required all of the following: complete disappearance of all target and non-target lesions sustained for at least 4 weeks; no new lesions, including no new leptomeningeal disease; no systemic corticosteroid dose.~Partial response required all of the following: ≥ 50% decrease compared with baseline in the size of all target lesions sustained for at least 4 weeks; no new lesions, including no new leptomeningeal disease and no unequivocal progression of non-target lesions, which, even in presence of stable disease or progressive disease in target lesions, was significant enough to qualify as progression; stable or reduced daily total systemic corticosteroid dose."|From randomization up to 24 months|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2651857|NCT01657799|Primary|Overall Survival|Overall survival was defined as the number of days from the date of randomization to the date of death. All events of death were included, regardless of whether the event occurred while the participant was still taking study treatment or after treatment was discontinued. If a participant had not died, the data were censored at the date the participant was last known to be alive.|From randomization up to 36 months|All randomized participants|||days||95% Confidence Interval|Median
2651858|NCT01657760|Secondary|Striatal Dopamine Receptor Availability in Alcohol Dependence With Citalopram, Compared to Placebo|relative binding potential of dopamine D2/3 receptor specific tracer compared to cerebellum, where there is known to be almost no dopamine receptors.|2-3 hours after 1 hour citalopram or placebo infusion||||striatal binding potential ratio||Standard Deviation|Mean
2651859|NCT01657760|Primary|Craving for Alcohol in Alcohol Dependence With Citalopram Compared to Placebo|"To assess whether craving for alcohol in alcohol dependence is affected by iv citalopram, compared to placebo.~Cue-induced craving for alcohol was assessed using the Alcohol Urge Questionnaire, composed of 8 questions with responses on a 0 (none) to 7 (severe or highest level) which when scored provide an estimate of the level of craving for alcohol for the participant. A maximum score is thus 56, indicating the highest level of craving for alcohol, whereas the minimum score of 0 indicates no appreciable craving for alcohol."|5 minutes after 1 hour of infusion intervention|All participants completed both arms|||score on a scale||Standard Deviation|Mean
2651860|NCT01657617|Secondary|Primary Tumor Relapse Following SBRT|The response rates of the residual primary tumor following SBRT boost will be determined using a modified version of the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Data will be presented as the percent of participants with recurrence of the primary tumor after extended follow up, up to 5 years.|Up to 5 years||||Participants|||Count of Participants
2651861|NCT01657617|Primary|Boost Dose Toxicity|Pneumonitis will be used as a marker of lung toxicity as a result of the Boost treatment. Participants will follow up with their treating physician annually for five years after treatment with SBRT . Any incidence of pneumonitis will be documented. Data will be presented as the percent of subjects receiving SBRT that required treatment for pneumonitis.|Up to 5 years||||Participants|||Count of Participants
2651862|NCT01657461|Other Pre-specified|Incidence of sICH at 27±6 Hours Post Randomization||27±6 hours post randomization|One subject in the IV t-PA arm withdrew and requested all data be removed.|||Participants|||Count of Participants
2651863|NCT01657461|Other Pre-specified|Incidence of All Serious Adverse Events (SAEs)||Through 90 days|One subject in the IV t-PA arm withdrew and requested all data be removed.|||Participants|||Count of Participants
2651864|NCT01657461|Secondary|Correlation of RAPID-assessed Core Infarct Volume With 27±6 Hours Post Randomization Stroke Infarction in Subjects Who Achieved TICI 2b-3 Reperfusion Without Intracranial Hemorrhage||27±6 hours post randomization|Final assessment not available for all subjects.|||Correlation|||Number
2651865|NCT01657461|Secondary|Arterial Revascularization Measured by TICI 2b or 3 Following Device Use||Post procedure|Final assessment not available for all subjects.|||Participants|||Count of Participants
2651866|NCT01657461|Secondary|Reperfusion Measured by Reperfusion Ratio on CT or MRI Scan 27±6 Hours Post Randomization||27±6 hours post randomization|Final assessment not available for all subjects.|||Reperfusion ratio||Standard Deviation|Mean
2651867|NCT01657461|Secondary|Volume of Cerebral Infarction as Measured by a CT or MRI Scan at 27±6 Hours Post Randomization||27±6 hours post randomization|Final assessment not available for all subjects.|||cc||Standard Deviation|Mean
2651868|NCT01657461|Secondary|Change in NIH Stroke Scale Score at 27 ± 6 Hrs Post Randomization|The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 - 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.|Baseline to 27±6 hours post randomization|Final assessment not available for all subjects.|||units on a scale||Standard Deviation|Mean
2651869|NCT01657461|Secondary|Functional Independence as Defined by Modified Rankin Scale (mRS) Score ≤2 at 90 Days||90 days|Final assessment unavailable for 5 subjects that withdrew consent or investigator withdrew consent in IV t-PA arm.|||Participants|||Count of Participants
2651870|NCT01657461|Secondary|Death Due to Any Cause at 90 Days||90 days|One subject in the IV t-PA arm withdrew and requested all data be removed.|||Participants|||Count of Participants
2651871|NCT01657461|Primary|90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS).|"mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. 0 No symptoms at all~No significant disability despite symptoms; able to carry out all usual duties and activities~Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance~Moderate disability; requiring some help, but able to walk without assistance~Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance~Severe disability; bedridden, incontinent and requiring constant nursing care and attention~Dead"|90 days|Final assessment unavailable for 5 subjects that withdrew consent or investigator withdrew consent in IV t-PA arm.|||Participants|||Count of Participants
2651872|NCT01657370|Other Pre-specified|Plasma MK-1602 Concentrations at Visit 2 (Day 4)||Up to 3.5 hours post dose 3|As per protocol, only listings of individual plasma concentrations for MK-1602 over time were produced. No formal non-compartmental PK analysis was done for this outcome measure.||||||
2651873|NCT01657370|Other Pre-specified|Dry Blood Spot MK-1602 Concentration at 3.5 Hours Post-Dose at Visit 2 (Day 4)||3.5 hours post dose 3|As per protocol, only listings of individual DBS concentrations for MK-1602 over time were produced. No formal non-compartmental PK analysis was done for this outcome measure.||||||
2651874|NCT01657370|Other Pre-specified|Dry Blood Spot (DBS) MK-1602 Concentrations on Migraine Treatment Day||Up to 24 hours post dose 1|As per protocol, only listings of individual DBS for MK-1602 over time were produced. No formal non-compartmental Pharmacokinetic (PK) analysis was done for this outcome measure.||||||
2651875|NCT01657370|Secondary|Percentage of Participants With TMF From 2-24 Hours Post-Dose on Migraine Treatment Day|TMF from 2-24 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2-24 hour period after dosing with study medication.|2-24 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.|||percentage of participants||95% Confidence Interval|Number
2651876|NCT01657370|Secondary|Percentage of Participants With Total Migraine Freedom (TMF) at 2 Hours Post-Dose on Migraine Treatment Day|TMF at 2 hours post-dose was defined as PF with no photophobia, phonophobia, nausea, or vomiting at 2 hours post-dose.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.|||percentage of participants||95% Confidence Interval|Number
2651877|NCT01657370|Secondary|Percentage of Participants With Sustained Pain Relief (SPR) From 2-24 Hours Post-Dose on Migraine Treatment Day|SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 2-24 hour period after dosing with study medication.|2-24 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.|||percentage of participants||95% Confidence Interval|Number
2651878|NCT01657370|Secondary|Percentage of Participants With Sustained Pain Freedom (SPF) From 2-24 Hours Post-Dose on Migraine Treatment Day|SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 2-24 hour period after dosing with study medication.|2-24 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.|||percentage of participants||95% Confidence Interval|Number
2651879|NCT01657370|Secondary|Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose on Migraine Treatment Day||2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.|||percentage of participants||95% Confidence Interval|Number
2651880|NCT01657370|Secondary|Percentage of Participants Reporting Absence of Photophobia at 2 Hours Post-Dose on Migraine Treatment Day|Photophobia is sensitivity to light.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.|||percentage of participants||95% Confidence Interval|Number
2651881|NCT01657370|Secondary|Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose on Migraine Treatment Day|Phonophobia is sensitivity to sound.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.|||percentage of participants||95% Confidence Interval|Number
2651882|NCT01657370|Primary|Percentage of Participants With Pain Relief (PR) at 2 Hours Post-Dose on Migraine Treatment Day|PR was defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at Baseline to a mild headache or no headache (Grade 1 or 0) 2 hours post dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.|||percentage of participants||95% Confidence Interval|Number
2651883|NCT01657370|Primary|Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose on Migraine Treatment Day|PF was defined as a decrease from a moderate or severe migraine headache (Grade 2 or 3) at Baseline to no pain (Grade 0) 2 hours post-dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.|2 hours post dose 1|Full Analysis Set included all participants who received study treatment, had a Baseline headache severity measurement, and at least one post-dose efficacy measurement prior to, or including, the 2-hour time point.|||percentage of participants||95% Confidence Interval|Number
2651885|NCT01657344|Primary|The Number of Visits Obtained From Electronic Health Record Data From the Sites|The number of visits obtained from electronic health record data from the sites|January 2012 - June 2016||||number of visits|||Number
2651886|NCT01657305|Secondary|Adverse Events by Relationship to Study Medication|Adverse events were assessed as being 'unlikely', 'possibly' or 'probably' related to study medication, 'not related' to study medication or the relationship to study medication was rated as 'unknown'.|Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).|The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Participants with adverse events (%)|||Number
2651887|NCT01657305|Secondary|Severity of Adverse Events|Adverse Events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) as being mild (NCI CTCAE Grade 1), moderate (NCI CTCAE Grade 2), severe (NCI CTCAE Grade 3), life-threatening (NCI CTCAE Grade 4) or death (NCI CTCAE Grade 5).|Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).|The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Participants with adverse events (%)|||Number
2651888|NCT01657305|Secondary|Frequency of Adverse Events||Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).|The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Participants with adverse events (%)|||Number
2651889|NCT01657305|Secondary|Pharmacokinetic (PK) Data (Plasma Betulin Concentration)|Systemic presence/concentration of betulin in blood plasma samples - values for the number of samples with measurable values in samples above the lower limit of quantification (LLOQ) of 1 ng/mL|up to 4 weeks|A total of 5 participants had a total of 5 samples with betulin concentrations above the LLOQ (1 ng/mL)|||Betulin (ng/mL)|Samples above LLOQ|Full Range|Mean
2651890|NCT01657305|Secondary|Pharmacokinetic (PK) Data (Number of Plasma Samples With Measurable Betulin Concentration)|Systemic presence/concentration of betulin in blood plasma samples. Plasma samples were collected in weekly intervals and at the end of treatment (when wound closure was achieved or at Day 28). Samples were analysed in a central laboratory with a validated LC-MS/MS method with a lower limit of quantification (LLOQ) of 1 ng/mL.|up to 4 weeks|The safety analysis population included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Plasma Samples|Plasma Samples||Number
2651891|NCT01657305|Secondary|Likert Scale Rating of Tolerability|Participants and investigators were asked to evaluate the tolerability of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only (standard of care) on a 5-point Likert scale (treatment with Oleogel-S10 is much better tolerated, treatment with Oleogel-S10 is better tolerated, both treatments are equally well tolerated, standard of care is better tolerated, standard of care is much better tolerated).|up to 4 weeks|The safety analysis population (SAF) included all participants who received treatment at least once, i.e. who received any dose of Oleogel-S10 or standard of care (SOC). If the application of any treatment was uncertain, the participant was included in the SAF.|||Percentage of participants|||Number
2651892|NCT01657305|Secondary|Cosmetic Outcome at 3 and 12 Months After Surgery, Respectively|Blinded photographic evaluation which wound half resembles more closely the surrounding skin with regard to texture, redness, growth of hair, and pigmentation.|3 months and 12 months|The intent-to-treat (ITT) analysis population included 87 participants for the 3-months follow-up and 83 participants for the 12-months follow-up.|||Percentage of wounds||95% Confidence Interval|Number
2651893|NCT01657305|Secondary|Likert Scale Rating of Efficacy|Participants and investigators were asked to grade the efficacy of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only on a 5-point Likert scale (treatment with Oleogel-S10 is much more effective, treatment with Oleogel-S10 is more effective, both treatments have the same efficacy, non-adhesive wound dressing only is more effective, non-adhesive wound dressing only is much more effective).|up to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form.|||Percentage of efficacy asssessments||95% Confidence Interval|Number
2651894|NCT01657305|Secondary|Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator|A study team member assessed the progress of wound healing by treatment regimen and noted the degree of epithelialization (expressed in percent of the original wound size) at wound dressing changes on Day 7, Day 10, Day 14, Day 18, Day 21, and Day 28.|up to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. Data were missing for n=1 participant at all time points.|||Area Percent of initial wound size||95% Confidence Interval|Mean
2651895|NCT01657305|Secondary|Percentage of Participants With Wound Closure at Different Time Points|For separate time points (Day 7, Day 10, Day 14, Day 18, Day 21, and Day 28), the frequencies of wound areas which have reached wound closure were calculated.|up to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. Data were missing for n=5 participants at all time points.|||Percentage with wound closure||95% Confidence Interval|Number
2651896|NCT01657305|Secondary|Percentage of Participants With Earlier Healing|Percentage of participants with earlier healing of wound area treated with Oleogel-S10 and non-adhesive wound dressing compared to non-adhesive wound dressing only|up to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form.|||Percentage with earlier healing||95% Confidence Interval|Number
2651915|NCT01657266|Secondary|Percentage of Patients Without Ocular Pain|percentage of patients without pain, would be measured using the Visual Analog Pain Scale|day 30|Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.|||percentage of patients|||Number
2651897|NCT01657305|Secondary|Time From Surgery Until Wound Closure is Achieved|Time from surgery until wound closure is achieved, separately for wound halves treated with Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing only. While outcome measure 1 (intra-individual difference in time to wound closure) was calculated based on mean intra-individual difference in time to wound closure in 107 participants with missing values replaced by a value of 0, for outcome measure 2 missing values were not replaced. For 5 of the 107 wounds data were missing, thus the reported values are calculated from 102 STSG donor site wound halves by intervention (Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing only).|up to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10 and who had signed an informed consent form. For 5 of the 107 wounds, data were missing, thus the reported values are calculated from 102 STSG donor site wound halves by intervention|||Days from surgery until wound closure|Number of STSG wound (halves) analyzed|95% Confidence Interval|Mean
2651898|NCT01657305|Primary|Intra-individual Difference in Time to Wound Closure|Intra-individual difference in time to wound closure between wound halves, either treated with Oleogel-S10 and non-adhesive wound dressing or treated with non-adhesive wound dressing only. Independent experts were blind to treatment and assessed efficacy based on chronological series of cropped and coded photographs by wound half that were taken before start of treatment, during wound dressing changes and at the end of treatment. Difference in time to wound closure was calculated for every individual participant as [time taken for wound half treated with Oleogel-S10 to close] - [time taken for wound half treated with non-adhesive wound dressing to close], i.e., results below 0 indicate earlier wound closure of Oleogel-S10 treatment. The overall mean difference in time to wound closure was calculated based on all mean differences in time to wound closure of individual participants. Hence, primary outcome data derived from mean difference in time to wound closure by participant.|up to 4 weeks|The intent-to-treat (ITT) analysis population included all participants who were treated at least once with study medication, i.e. who received any dose of Oleogel-S10.|||days||95% Confidence Interval|Mean
2651899|NCT01657292|Secondary|Assessment of Adverse Events||2 to 3 weeks|||||||
2651900|NCT01657292|Secondary|Microbial Colonization of the Wound Halves||2 to 3 weeks|||||||
2651901|NCT01657292|Secondary|PK Data: Systemic Presence/Concentration of Betulin in Blood Plasma Samples||2 to 3 weeks|||||||
2651902|NCT01657292|Secondary|Likert Scale Rating of Tolerance (Evaluated by Both the Investigators and Patients)|By direct comparison of the separate simultaneous treatments for the two wound halves, patients and investigators, respectively, are asked to provide their opinion on the tolerance of Oleogel-S10 Versus Standard of Care on a questionnaire with a 5-point graded visual analogue scale|2 to 3 weeks|||||||
2651903|NCT01657292|Secondary|Cosmetic Outcome After 3 and 12 Months After Burn Accident, in Relation to Texture, Redness, Growth of Hair and Pigmentation, Based on Blinded Photo Evaluation||3 and 12 months|||||||
2651904|NCT01657292|Secondary|Likert Scale Rating of Efficacy (Evaluated by Both the Investigators and Patients)|By direct comparison of the separate simultaneous treatments for the two wound halves, patients and investigators, respectively, are asked to grade the efficacy of Oleogel-S10 Versus Standard of Care on a questionnaire with a 5-point graded visual analogue scale|2 to 3 weeks|||||||
2651905|NCT01657292|Secondary|Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator||2 to 3 weeks|||||||
2651906|NCT01657292|Secondary|Percentage of Patients With Wound Closure at Different Time Points||2 to 3 weeks|||||||
2651907|NCT01657292|Secondary|Time From Study Start After Burn Accident Until Wound Closure is Achieved Separately for Wound Halves Treated With Oleogel-S10 vs. Standard of Care||2 to 3 weeks|||||||
2651908|NCT01657292|Secondary|Intra-individual Difference in Time to Wound Closure Between Wound Halves, Either Treated With Oleogel-S10 or Treated With Standard of Care||2 to 3 weeks|||||||
2651909|NCT01657292|Primary|Percentage of Patients With Earlier Healing of the Wound Half Treated With Oleogel-S10 Compared to the Wound Half Receiving Standard of Care|Photo-based evaluation by independent experts blinded to the treatment regime.|2 to 3 weeks|The analysis included all patients who were treated at least once with Oleogel-S10 or Octenilin® wound gel (as randomised) and for whom a difference in wound healing between the treatment was observed.|||percentage of patients||95% Confidence Interval|Number
2651910|NCT01657266|Other Pre-specified|Retinal Thickness|Change from Baseline in retinal thickness after 30 days of treatment. A third measurement will be done at 60 day after day surgery.|day 30 and 60|Mexican patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.|||μm||Standard Deviation|Mean
2651911|NCT01657266|Other Pre-specified|Intraocular Pressure|Change from Baseline in the intraocular pressure after 30 days of treatment|day 30|Mexican patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.|||mmHg||Standard Deviation|Mean
2651912|NCT01657266|Other Pre-specified|Epithelial Defects Detected With Green Lissamine|the percentage of patients presenting epithelial defects evaluated with green lysine will be reported|measurements will be made at days 1, 5, 7 and 30|Mexican patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.|||percentage of patients with defects|||Number
2651913|NCT01657266|Other Pre-specified|Epithelial Defects Detected With Fluorescein|The percentage of patients presenting epithelial defects with fluorescein staining will be evaluated|measurements will be made at days 1, 5, 7 and 30|Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.|||percentage of patients with defects|||Number
2651914|NCT01657266|Secondary|Mean Aqueous Concentration of Intervention Drug|a nurse was instructed to instill five drops of the research product into each patient's eye in the hour before surgery. The concentration of the drug was determined for aqueous humor sample (0.15 mL) with a 30-gauge needle on a TB syringe after completion of the paracentesis. The paracentesis was performed after first incision during the phacoemulsification.|before surgery|We enrolled patients of both sexes (aged >18 years) with a diagnosis of cataract according to the Lens Opacities Classification System III ≤ NC4, C4 and, P4 in one eye were eligible for enrollment. Eligible patients must have had a best-corrected visual acuity of 6/60 (20/200) Snellen score.|||ng/mL|eyes|Standard Deviation|Mean
2651916|NCT01657266|Primary|Flare in Anterior Chamber|Percentage of Participants with flare in anterior chamber after 30 days of treatment|day 30|Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.|||Percentage of Participants with flare|||Number
2651917|NCT01657266|Primary|Percentage of Cellularity in Anterior Chamber|Change from Percentage of Cellularity in anterior chamber after 30 days of treatment.|day 30|Mexican patients patients who underwent cataract surgery in only 1 eye, by phacoemulsification with intraocular lens implantation.|||Percentage of Cellularity|||Number
2651918|NCT01657253|Secondary|Tear Film Break up Time|Change from Baseline in Tear film break up time after 60 days of treatment Tear film breakup time is the elapsed time from blinking to the first occurrence of a dry area in the cornea, visualized with the help of fluorescein staining. Measurement of tear film breakup time will be performed as follows: Fluorescein is instilled in the eye, the patient is asked to blink three times to distribute the dye and then set the eye to the front and do not blink while the examiner observes the cornea with cobalt blue light, looking for an area of tear film rupture, which is manifested by the appearance of a black island within the fluorescein green film. Normally film breakup time is 10 seconds or more and the minimum register may be 1 second, Under 10 seconds is considered abnormal.|Day 60||||seconds|eyes|Standard Deviation|Mean
2651919|NCT01657253|Secondary|Schirmer Test|"Change from Baseline in Schirmer test after 60 days of treatment~Schirmer test~It is the technique most used to measure aqueous and at the same time the simplest tear secretion. It is carried out as follows: Without applying anesthesia, the patient is placed somewhere without much illumination, without applying anesthesia, a strip of filter paper of approximately 30 mm is placed, of which, 5 mm must go in the joint Of the middle and outer third of the lower eyelid. The patient is instructed to look forward and to blink normally. After 5 minutes the strips are removed and the wetting is recorded in millimeters. A test less than or equal to 6 mm is diagnostic of aqueous deficiency.The mean of the revisions by group will be compared at the baseline and final visit."|Day 60||||mm/min|eyes|Standard Deviation|Mean
2651920|NCT01657253|Primary|Ocular Surface Disease Index (OSDI©) Questionnaire|Ocular Surface Disease Index (OSDI©) questionnaire , consists of 12 questions divided in 3 groups, Each question has a value that can go from 0 to 4 points according to the severity of the case: 0.None of the time, 1. Some of the time, 2.Half of the time, 3.most of the time and 4 all of the time. The points of all the questions will be used in the following formula for converted to a score of 0-100 : (sum of scores) x 25 / (# of questions answered), where 0 represents normality or non-symptomatology and 100 the most severe case. Will be used to measure the symptoms of dry eye disease by obtaining baseline data and comparing them against the last visit.|Day 60||||points|eyes|Standard Deviation|Mean
2651921|NCT01657032|Secondary|Duration of Intravenous Therapy|need for intravenous rehydration therapy (how long if needed)|7days||||days||Inter-Quartile Range|Median
2651922|NCT01657032|Secondary|Need for Intravenous Therapy|need for intravenous rehydration therapy (yes/no)|yes/no, for 7days||||participants|||Number
2651923|NCT01657032|Secondary|Need for Hospitalization|If the child need to hospitalized|7 days||||participants|||Number
2651924|NCT01657032|Secondary|Tolerance of Products|tolerance of products (whether the child took medicaments),|7days||||participants|||Number
2651925|NCT01657032|Secondary|Diarrhea Recurrence|If the was a diarrhea recurrence during 7days|7 days||||participants|||Number
2651926|NCT01657032|Secondary|Vomiting|How many times the child was vomiting (during the study)|how many times for 7days||||vomiting episodes||Inter-Quartile Range|Median
2651927|NCT01657032|Secondary|Vomiting|If the child vomiting after randomization (yes/no)|yes/no, for 7days||||participants|||Number
2651928|NCT01657032|Secondary|Need for Antibiotic Therapy,|need for antibiotic therapy because of diarrhea|yes/no, for 7days||||participants|||Number
2651929|NCT01657032|Secondary|Consistency of Stools|"consistency of stools using Bristool Stool Scale Form on day 4-th. (The Bristol stool scale form is a medical aid designed to classify the form of human faeces into seven categories.~Type 1 Separate hard lumps, like nuts (hard to pass) Type 2 Sausage-shaped but lumpy Type 3 Like a sausage but with cracks on the surface Type 4 Like a sausage or snake, smooth and soft Type 5 Soft blobs with clear-cut edges Type 6 Fluffy pieces with ragged edges, a mushy stool Type 7 Watery, no solid pieces. Entirely liquid Types 1-2 indicate constipation, with 3 and 4 being the ideal stools (especially the latter), as they are easy to defecate while not containing any excess liquid, and 5, 6 and 7 tending towards diarrhoea."|day 4-th||||Units on a scale||Inter-Quartile Range|Median
2651930|NCT01657032|Secondary|Frequency of Loose Stools,|number of loose stools during 7 days|number of loose stools during 7 days||||number of loose stools during 7days||Inter-Quartile Range|Median
2651931|NCT01657032|Primary|Duration of Diarrhea|The primary outcome measure is duration of diarrhea (counted in days; from the first loose stool to the last one; end of diarrhea defined as last loose stool or at least 12hours without stool).|counted in days during 7days||||days||Inter-Quartile Range|Median
2651932|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the anxiety/depression questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.|||percentage of participants at ET|||Number
2651998|NCT01656434|Primary|Number of In-Treatment Pregnancies Per 100 Woman Years of Exposure (Pearl Index)|Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure.|Up to 1 year (13 cycles)|Planned analysis for this primary endpoint was not performed due to early study termination.||||||
2651933|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the pain/discomfort questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.|||percentage of participants at ET|||Number
2651934|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the usual activities questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.|||percentage of participants at ET|||Number
2651935|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the self care questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.|||percentage of participants at ET|||Number
2651936|NCT01657019|Secondary|Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility|The EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the mobility questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.|End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.|||percentage of participants at ET|||Number
2651937|NCT01657019|Secondary|Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q)|The EDE-Q is a 28-item questionnaire measuring eating pathology and is derived directly from the Eating Disorder Examination Interview. The EDE-Q focuses on the past 28 days to assess the main behavioral (eating and purging) and attitudinal features of eating disorders. The 28 items are rated by the participant on a 7-point scale (ranging from 0 to 6), with higher scores indicating increased pathology. The EDE-Q includes 4 subscales: Restraint, Eating Concern, Weight Concern, and Shape Concern. The global score is the average of all 28 items, with a range of 0 to 6. A negative value indicates a favorable result. The values presented are the mean change from baseline.|Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.|||units on a scale||Standard Deviation|Mean
2651938|NCT01657019|Secondary|Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale|The CGI rating scales permitted the global evaluation of a participant's condition severity and improvement over time. The CGI-I was performed to rate the improvement of a participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse) and included a 'not assessed' option. The responses were dichotomized into 2 categories (improved or not improved). Improved included very much improved and much improved; not improved included minimally improved, no change, minimally worse, much worse, and very much worse. Not assessed and missing values were excluded from the percentage calculation.|Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)|The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.|||percentage of participants||95% Confidence Interval|Number
2652424|NCT01652703|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.|||percent change||Standard Error|Least Squares Mean
2651939|NCT01657019|Primary|Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS)|"Suicidality was assessed by using the C-SSRS, a semi-structured interview designed to capture the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview and rating for the C-SSRS was completed by a clinician who had been successfully trained by the sponsor or designee. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answers to the first 2 ideation questions were yes, the clinician asked questions 3-5. Active suicidal ideation included any participant who answered yes to questions 2-5. If the answers to ideation questions 1 and 2 were no, then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide."|53 weeks|The Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.|||participants|||Number
2651940|NCT01657019|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety||52 weeks|The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.|||percentage of participants|||Number
2651941|NCT01656967|Other Pre-specified|Orolaryngeal Pressure|The oropharyngeal leak pressure (OLP) was determined by closing the expiratory valve of the circle system at a fixed gas flow of 3 L/min and noting the airway pressure at which equilibrium was reached (not permitted to exceed 40 cm H2O).|Following SGA Insertion||||mmHg||Inter-Quartile Range|Median
2651942|NCT01656967|Secondary|Post-Operative Discomfort Upon Leaving the Post-Anesthesia Care Unit (PACU)|The patient will be assessed for Post-Operative Hoarseness, Sore Mouth, Sore Neck, Sore Jaw, Dysphonia, Dysphagia, and Altered Tongue Sensation.|Approximately 1-2 hours after entering the PACU||||participants|||Number
2651943|NCT01656967|Secondary|Post-Operative Discomfort Upon Entering the Post-Anesthesia Care Unit (PACU)|The patient will be assessed for Post-Operative Hoarseness, Sore Mouth, Sore Neck, Sore Jaw, Dysphonia, Dysphagia, and Altered Tongue Sensation.|Within 30 minutes of completion of surgery||||participants|||Number
2651944|NCT01656967|Secondary|Number of Participant With Overall Intubation Success|Ease of ETT insertion is subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 5 = extremely difficult).|At ETT insertion||||participant|||Number
2651945|NCT01656967|Secondary|Number of Participants With Overall Success for SGA Placement|Ease of SGA insertion is subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 5 = extremely difficult).|At SGA insertion||||participants|||Number
2651946|NCT01656967|Secondary|Number of Participants in Whom ETT Insertion Was Successful on the First Attempt||At ETT insertion||||participants|||Number
2651947|NCT01656967|Secondary|Number of Participants in Whom SGA Insertion Was Successful on the First Attempt||At SGA insertion||||participants|||Number
2651948|NCT01656967|Secondary|Time for Endotracheal Tube (ETT) Insertion|After the SGA is inserted, time for intubation will be recorded. Time for ETT insertion was measured, for arm 1, from when the AMBU aScope is at the connector level of the Aura-I or, for arm 2, from when the ETT is at the connector level of the Intubating LMA to first detection of CO2 on the capnogram. The AScope 2 disposable fiberoptic camera will be used to assist with intubation for Group 1 patients. Group 2 patients will be intubated using the LMA-Fastrach EndoTracheal Tube.|At ETT insertion||||seconds||Inter-Quartile Range|Median
2651949|NCT01656967|Secondary|Time for Supraglottic Airway (SGA) Insertion|Time for SGA insertion was measured from when the tip of the cuff was at the mouth to detection of CO2 on the capnogram.|At SGA insertion||||seconds||Inter-Quartile Range|Median
2651950|NCT01656967|Primary|Total Intubation Time|Total Intubation Time includes time for SGA insertion and for ETT insertion. The total time to intubation was measured from the beginning of SGA insertion to successful endotracheal tube intubation verified by detection of CO2 on the capnogram.|Duration of Intubation, including supraglottic airway (SGA) insertion and endotracheal tube (ETT) insertion||||seconds||Inter-Quartile Range|Median
2651951|NCT01656889|Secondary|Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on the Median Time (in Days) to Closure Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was based on a Kaplan-Meier survival analysis.|12 weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using a Kaplan-Meier Survival Analysis, with significance being at P < 0.05.|||days to wound closure||Full Range|Median
2651952|NCT01656889|Secondary|Change in Target Ulcer Pain|Target ulcer pain were measured using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.|Weekly, over 12 week treament period, baseline|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.|||units on a scale||Standard Error|Least Squares Mean
2651953|NCT01656889|Secondary|Change in Pain Associated With the Target Leg at Each of the 12 Double Blind Treatment Weeks|Target leg pain were measured using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain.|Weekly, over the 12 week treatment period, baseline|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed by an ANCOVA, adjusted for site and baseline score.|||units on a scale||Standard Error|Least Squares Mean
2651954|NCT01656889|Secondary|Number of Subjects With Durable Wound Healing Over the 3 Months Following Complete Wound Closure|Subjects who completed the treatment period with confirmed wound closure were followed in the post-treatment period for a further two months to determine their closed wound status (remained closed/reopened), giving a measure of persistence of wound closure following completion of treatment.|Target ulcer status observed at two and three months following initial ulcer closure.|"The 285 subjects (HP802-247: 141/222; Vehicle: 144/225) who completed the treatment period with confirmed wound closure.~Subjects returning for Visit 1 with confirmed wound closure at end of treatment: 134 HP802-247 and 132 Vehicle.~Subjects returning for Visit 2 with confirmed wound closure at end of treatment: 132 HP802-247 and 131 Vehicle"|||participants|||Number
2651955|NCT01656889|Secondary|Compare the Treatment Groups for the Percentage of Closed Ulcers at Each Visit of the 12-Week Treatment Period From Baseline|Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.|Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first|ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test, adjusted for sites, with significance being at P < 0.05|||percentage of Closed Ulcers|||Number
2651956|NCT01656889|Secondary|Compare the Efficacy of the Treatment Groups in Achieving Complete Wound Closure, Based on Time in Days to Closure Over the 12-Week Treatment Period From Baseline.|This key secondary outcome was based on a Cox Proportional Hazard Analysis and a Kaplan-Meier survival analysis.|12 Weeks|ITT Populations: Subjects who received at least one dose of test article. Data were analyzed using the Cox Proportional hazard procedure, with significance being at P < 0.05 and by the Kaplan-Meier survival procedure|||days||Full Range|Median
2651957|NCT01656889|Primary|Compare the Treatment Groups for the Proportion of Subjects With Complete Wound Closure Over the 12-Week Treatment Period From Baseline|For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area. Following initial closure subjects returned for four weekly visits to confirm wound closure. Wounds that remained closed for four weeks were classified as confirmed closures; if a wound opened at any of the 4 visits it was not considered to have closed. For subjects who dropped from the study, their remaining visit values were imputed using LOCF; wound status of closed was not imputed.|12 Weeks|ITT Populations: Subjects who received at least one dose of test article. Analysis was by the Cochrane Mantel Haenszel (CMH) test, adjusted for sites, with significance being at P < 0.05|||participants|||Number
2651958|NCT01656850|Primary|Plasma Vitamin E Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||μmol/L||Standard Deviation|Mean
2651959|NCT01656850|Primary|Urine Isoproterenol Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||ng/mg creatinine||Standard Deviation|Mean
2651960|NCT01656850|Primary|Plasma Oxide LDL Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||U/L||Standard Deviation|Mean
2651961|NCT01656850|Primary|Plasma Protein Carbonyl Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||nmol/mg||Standard Deviation|Mean
2651962|NCT01656850|Primary|Endothelial Function at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||ng/mL||Standard Deviation|Mean
2651963|NCT01656850|Primary|Plasma Nitric Oxide Level at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||μmol/L||Standard Deviation|Mean
2651964|NCT01656850|Primary|Plasma Apolipoprotein Level at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||g/L||Standard Deviation|Mean
2651965|NCT01656850|Primary|HOMA at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||pg/mL||Standard Deviation|Mean
2651966|NCT01656850|Primary|Plasma HbA1c Level at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||percentage of hemoglubin||Standard Deviation|Mean
2651967|NCT01656850|Primary|Area Under Curve of Plasma Insulin After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||mU.min/L||Standard Deviation|Mean
2651968|NCT01656850|Primary|Plasma Fasting Insulin at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||mU/L||Standard Deviation|Mean
2651969|NCT01656850|Primary|Area Under Curve of Plasma Glucose After Eating Standard Breakfast at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||mg.min/dL||Standard Deviation|Mean
2651970|NCT01656850|Primary|Plasma Fasting Glucose at the Baseline and the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||mg/dL||Standard Deviation|Mean
2651971|NCT01656850|Primary|Blood Pressure at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||mmHg||Standard Deviation|Mean
2651972|NCT01656850|Primary|Body Fat Percentage at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||percentage of body weight||Standard Deviation|Mean
2651973|NCT01656850|Primary|Body Weight at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||kg||Standard Deviation|Mean
2651974|NCT01656850|Primary|Lipid Composition of NCEP Step 2 Diet and Almond Diets||the entire study, up to 3 months||||g||Standard Deviation|Mean
2651975|NCT01656850|Primary|The Calories of NCEP Step 2 Diet and Almond Diets||the entire study, up to 3 months||||kcal||Standard Deviation|Mean
2651976|NCT01656850|Primary|Plasma Lipid Profiles at the Baseline and at the End of 3-month Dietary Intervention||at the baseline and at the end of 3-month dietary intervention||||mg/dL||Standard Deviation|Mean
2651977|NCT01656850|Primary|The Major Nutrients of NCEP Step 2 Diet and Almond Diets||the entire study, up to 3 months||||% of energy||Standard Deviation|Mean
2651978|NCT01656772|Primary|Safety Outcome to be Assessed by Comparing the Rate of Adjudicated Serious Adverse Events Within 7 Days of the Procedure Between Both the Control and the Investigational Device Groups.|The Vdrive will allow physicians to manipulate compatible circular mapping catheters while maintaining a safety profile that is not inferior to manual circular catheter navigation. The one-sided null hypothesis was to be tested at the α = 0.05 significance level using a standard unpooled asymptotically normal test statistic. The null hypothesis was to be rejected if Z < -1.7046 or, equivalently, if the corresponding p-value was less than 0.05.|7 days Follow-up||||participants|||Number
2652446|NCT01652573|Secondary|Number of Participants With Allergic Reactions at Baseline|This symptom will be assessed at baseline|Time 0||||Participants|||Count of Participants
2651979|NCT01656772|Primary|The Primary Effectiveness Endpoint is the Successful Navigation and EGM Recording of Each Pre-specified Pulmonary Vein Per Procedure Between Both the Control and the Investigational Device Groups.|Success was navigating and sensing by obtaining an EGM at the pre-specified targeted PVs. The null hypothesis was to be tested at the α = 0.05 significance level using a test statistic Z based on the Farrington and Manning likelihood score statistic with adjustment to take into account the correlation between multiple observations (PVs) on the same subject. The null hypothesis was to be rejected if Z > 1.645 or, equivalently, if the corresponding p-value was less than 0.05.|Peri-procedural|All adverse events reported by the sites were independently adjudicated by the data safety monitory, DSM.|||Pulmonary Veins|Participants||Number
2651980|NCT01656759|Secondary|Postoperative Blood Loss|Measured as drainage output from postoperative drains during hospitalization.|3 days||||mL||Standard Deviation|Mean
2651981|NCT01656759|Secondary|Total Transfusions|The number of transfusions each patient receives during their postoperative hospitalization.|3 days||||Number of transfusions|||Number
2651982|NCT01656759|Primary|Total Blood Loss|Combination of intraoperative and postoperative blood loss for participants.|Collected during surgery and in first 2-3 days after surgery||||mL||Standard Deviation|Mean
2651983|NCT01656759|Primary|Primary--Percent Change of Pre- to Post-Operative Hemoglobin|Pre-operative hemoglobin values from routine CBC no earlier than 1 month prior to surgery were compared to post-operative hemoglobin values from routine CBC after surgery.|Pre-operative to 1 month||||Percent Change||Standard Deviation|Mean
2651984|NCT01656733|Secondary|Gestational Age|Measure of age of pregnancy at delivery|At delivery|Could not obtain birth outcomes on 4 individuals in nicotine group for various reasons.|||weeks||Standard Deviation|Mean
2651985|NCT01656733|Secondary|Birth Weight|Birth weight in grams|At delivery|Could not obtain birth outcomes on 4 individuals in nicotine group for various reasons.|||Grams||Standard Deviation|Mean
2651986|NCT01656733|Secondary|Exhaled Carbon Monoxide|As measured by parts per million (ppm) on CO breathalyzer|32-34 weeks gestation|Overall number of participants includes only those that attended the 32-34 gestation week visit|||parts per million||Standard Deviation|Mean
2651987|NCT01656733|Primary|Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days|Number of participants who self report an average of zero cigarettes smoked per day in preceding 7 days|32-34 weeks gestation (Visit 6)||||Participants|||Count of Participants
2651988|NCT01656629|Secondary|Difference in Osteogenic Potential of Bone Marrow as Measure by Colony Forming Unit Osteoblast (CFU-Ob) Assays Between Treatment Groups||3 months|||||||
2651989|NCT01656629|Secondary|Difference in Bone Formation as Assessed by Bone Histomorphometry on Bone Biopsy Between Treatment Groups||3 months|||||||
2651990|NCT01656629|Primary|The Percent Change in Circulating Osteoprogenitor Cells as Assessed by Flow Cytometry in the Blood Before and After Treatment With Parathyroid Hormone (PTH) or Alendronate (ALN).||up to 3 months||||percent change in osteoprogenitor cells||Standard Deviation|Mean
2651991|NCT01656486|Primary|Decreased Secretions|Measurement of pancreatic panel, decreased Pancreatic Secretions|1 year||||participants|||Number
2651992|NCT01656460|Primary|Early and Intermediate Toxicity for Dose Limiting Toxicity|"Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Serious adverse events will be captured from the time the patient signs consent until 12 weeks after the last SBRT.~DLTS: defined in protocol as: Dose limiting toxicities will be defined as grade 3 or greater treatment related pneumonitis, cardiac toxicity, bronchial injury or chest wall pain during or within 4 weeks of completion of SBRT."|3 months||||participants|||Number
2651993|NCT01656434|Secondary|Change From Baseline in Body Weight|Participants' body weights were measured in a consistent manner throughout the trial, using standardized equirpment. Last In-Treatment Measurement refers to a participant's end of trial visit, the timing of which differed among participants.|Baseline and Week 52|Participants from All Subjects as Treated Population (all randomized participants who took at least one dose of trial medication) who had data available for Change from Baseline in Body Weight endpoint.|||kilograms||Standard Error|Mean
2651994|NCT01656434|Secondary|Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event||Up to 54 weeks|All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses.|||Participants|||Number
2651995|NCT01656434|Secondary|Percentage of Participants Who Experienced At Least One Adverse Event|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.|Up to 54 weeks|All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses.|||Percentage of Participants|||Number
2651996|NCT01656434|Secondary|Percentage of Participants With an Absence of Withdrawal Bleeding|Participants kept e-diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period.|Up to 1 year (13 cycles)|Planned analysis for this secondary endpoint was not performed due to early study termination.||||||
2651997|NCT01656434|Secondary|Percentage of Participants With an Occurrence of Breakthrough Bleeding/Spotting|"Participants kept e-diaries to record their vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as breakthough bleeding.) Vaginal bleeding that required >=1 pad/tampon per day was classified as BLEEDING. Vaginal bleeding that did not require a pad/tampon per day was classified as SPOTTING."|Up to 1 year (13 cycles)|Planned analysis for this secondary endpoint was not performed due to early study termination.||||||
2652447|NCT01652573|Secondary|Number of Participants With Nasal Ulcerations at Baseline|This symptom will be assessed at baseline|Time 0||||Participants|||Count of Participants
2652448|NCT01652573|Secondary|Number of Participants With Nasal Congestion at 3 Months|This symptom will be assessed.|Time 3 months||||Participants|||Count of Participants
2651999|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652000|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652001|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mmHg||Standard Error|Least Squares Mean
2652002|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||percentage of central pulse pressure||Standard Error|Least Squares Mean
2652003|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652004|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652011|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652005|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652006|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||percentage of pulse pressure||Standard Error|Least Squares Mean
2652007|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652008|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652009|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652010|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||percentage of central pulse pressure||Standard Error|Least Squares Mean
2652096|NCT01656252|Primary|Phase I - Dose Level With Best Kinetics of Platelet Count Recovery|To describe the kinetics of platelet count recovery in acute myeloid leukemia patients in complete remission receiving intensive consolidation chemotherapy who will be receiving eltrombopag. This is assessed graphically by plotting platelet count vs. days relative to start of cytarabine for each patient.|13 months||||mg|||Number
2652012|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652013|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652014|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||percentage of central pulse pressure||Standard Error|Least Squares Mean
2652015|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652016|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652017|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652032|NCT01656408|Primary|Tmax of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Full Range|Median
2652449|NCT01652573|Secondary|Number of Participants With Nasal Congestion at 2 Months|This symptom will be assessed.|Time 2 months||||Participants|||Count of Participants
2652018|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||percentage of central pulse pressure||Standard Error|Least Squares Mean
2652019|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652020|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652021|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652022|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||percentage of central pulse pressure||Standard Error|Least Squares Mean
2652023|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pDBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652450|NCT01652573|Secondary|Number of Participants With Nasal Congestion at 1 Month|This symptom will be assessed.|Time 1 month||||Participants|||Count of Participants
2652024|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs pSBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652025|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs cDBP Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652026|NCT01656408|Secondary|Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||percentage of central pulse pressure||Standard Error|Least Squares Mean
2652027|NCT01656408|Primary|t1/2 of MK-8150 Determined Following Day 28 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 28.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure|||hr||Geometric Coefficient of Variation|Geometric Mean
2652028|NCT01656408|Primary|Tmax of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure|||hr||Full Range|Median
2652029|NCT01656408|Primary|Cmax of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure|||μM||Geometric Coefficient of Variation|Geometric Mean
2652030|NCT01656408|Primary|AUC0-24 of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel I/J, Including Only Participants Who Completed Treatment)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 28 was determined.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and completed the 28 days of treatment, and had data available for the measure|||μM*hr||Geometric Coefficient of Variation|Geometric Mean
2652031|NCT01656408|Primary|t1/2 of MK-8150 Determined Following Day 10 Dose in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 10.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Geometric Coefficient of Variation|Geometric Mean
2655555|NCT01624662|Secondary|Hyposmia Score (7-day Instantaneous Morning)|Change from baseline in hyposmia symptoms, as measured by AM and PM diary symptom scores|Week 16 of the double-blind treatment phase||||units on a scale||Standard Error|Least Squares Mean
2652033|NCT01656408|Primary|Cmax of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM||Geometric Coefficient of Variation|Geometric Mean
2652034|NCT01656408|Primary|AUC0-24 of MK-8150 in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 (Panel H)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 10 was determined.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM*hr||Geometric Coefficient of Variation|Geometric Mean
2652035|NCT01656408|Primary|t1/2 of MK-8150 Determined Following Day 28 Dose in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 28.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Geometric Coefficient of Variation|Geometric Mean
2652036|NCT01656408|Primary|Tmax of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Full Range|Median
2652037|NCT01656408|Primary|Cmax of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 28 was determined from the observed plasma concentration-time data.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM||Geometric Coefficient of Variation|Geometric Mean
2652038|NCT01656408|Primary|AUC0-24 of MK-8150 in Healthy Male Participants Administered Multiple Doses of MK-8150 (Panel G)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 28 was determined.|Day 1: Pre-dose and 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose; Day 28: Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM*hr||Geometric Coefficient of Variation|Geometric Mean
2652039|NCT01656408|Primary|t1/2 of MK-8150 Determined Following Day 15 Dose in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 15.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Geometric Coefficient of Variation|Geometric Mean
2652040|NCT01656408|Primary|Tmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 6 and Day 15 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 15 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Full Range|Median
2652041|NCT01656408|Primary|Cmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 6 and Day 15 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 15 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM||Geometric Coefficient of Variation|Geometric Mean
2652042|NCT01656408|Primary|AUC0-24 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel E/F, Days 6-15)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 6 and Day 15 was determined.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM*hr||Geometric Coefficient of Variation|Geometric Mean
2652043|NCT01656408|Primary|t1/2 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the Day 1 dose.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Geometric Coefficient of Variation|Geometric Mean
2652451|NCT01652573|Secondary|Area Under the Curve for 1,25(OH)2vitamin D|Serum 1,25(OH)2vitamin D will be measured 0 to 24 hours post dose during a 24 hr admission and AUC calculated and results will be compared to baseline values.|Time 3 months||||ng/ml*hr||95% Confidence Interval|Least Squares Mean
2652044|NCT01656408|Primary|Tmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Full Range|Median
2652045|NCT01656408|Primary|Cmax of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM||Geometric Coefficient of Variation|Geometric Mean
2652046|NCT01656408|Primary|AUC0-24 of MK-8150 in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 (Panel E/F, Day 1 Dose)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 was determined.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM*hr||Geometric Coefficient of Variation|Geometric Mean
2652047|NCT01656408|Primary|Apparent Terminal Half-life (t1/2) of MK-8150 Determined Following Day 10 Dose in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)|Serial plasma samples for determination of PK parameters were obtained from study participants. t1/2 is the time it takes for the concentration of the drug in the body to decrease by half during the elimination phase. t1/2 of MK-8150 was determined from plasma drug concentration data obtained following the last dose of study drug, administered on Day 10.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Geometric Coefficient of Variation|Geometric Mean
2652048|NCT01656408|Primary|Time to Maximum Observed Plasma Concentration (Tmax) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)|Serial plasma samples for determination of PK parameters were obtained from study participants. Tmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||hr||Full Range|Median
2652049|NCT01656408|Primary|Maximum Observed Plasma Concentration (Cmax) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)|Serial plasma samples for determination of PK parameters were obtained from study participants. Cmax of MK-8150 on Day 1 and Day 10 was determined from the observed plasma concentration-time data.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose, and (for Day 10 only) 48, 72 and 96 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM||Geometric Coefficient of Variation|Geometric Mean
2652050|NCT01656408|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of MK-8150 in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 (Panel A/B/C/D)|Serial plasma samples for determination of PK parameters were obtained from study participants. AUC0-24 of MK-8150 on Day 1 and Day 10 was determined.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||μM*hr||Geometric Coefficient of Variation|Geometric Mean
2652051|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||beats per minute||Standard Error|Least Squares Mean
2652052|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel J)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652067|NCT01656395|Secondary|Percentage of Asthma Attack Days|An asthma attack was defined as asthma symptoms during the previous 24 hours requiring one or more of the following: corticosteroid use (systemic), unscheduled visit to the doctor or urgent care clinic, unscheduled visit to the emergency department or hospitalization. Information on asthma attacks was recorded throughout the study in the participant's e-Diary, and an Analysis of Variance (ANOVA) was used to calculate the average percentage of asthma attack days over Week 6 to Week 12 of a 12-week treatment period.|Week 6 to Week 12|TH2-High participants who received ≥1 study drug dose and had asthma attack data.|||Percentage||95% Confidence Interval|Least Squares Mean
2676190|NCT01440569|Primary|Percentage of Participants With Onset of Any Treatment-emergent Grade 3 or 4 Adverse Event Between Baseline and Week 24||Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
2652053|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||beats per minute||Standard Error|Least Squares Mean
2652054|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel I)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652055|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||beats per minute||Standard Error|Least Squares Mean
2652056|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Male and Female Participants With Resistant Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel H)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value (determined separately in each period).|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652057|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||beats per minute||Standard Error|Least Squares Mean
2652058|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Multiple Doses of MK-8150 and Placebo (Panel G)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652059|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||beats per minute||Standard Error|Least Squares Mean
2652060|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel F)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652061|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||beats per minute||Standard Error|Least Squares Mean
2652062|NCT01656408|Primary|Change From Baseline in TWA0-24hrs cSBP in Elderly Male and Female Participants With Mild to Moderate Hypertension Administered Single and Multiple Doses of MK-8150 and Placebo (Panel E)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline for Day 1 was Day 1 pre-dose value; Baseline for Day 6-15 was Day 6 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652063|NCT01656408|Primary|Change From Baseline in TWA0-24hrs HR in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||beats per minute||Standard Error|Least Squares Mean
2652064|NCT01656408|Primary|Change From Baseline in Time-weighted Average Across 24 Hours (TWA0-24hrs) cSBP in Male Participants With Mild to Moderate Hypertension Administered Multiple Doses of MK-8150 and Placebo (Panel A/B/C/D)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. Baseline was Day 1 pre-dose value.|Pre-dose and 2, 3, 4, 6, 8, 12 and 24 hours post dose|All participants who met protocol entry criteria, received study drug and had data available for the measure|||mm Hg||Standard Error|Least Squares Mean
2652065|NCT01656408|Primary|Number of Participants Discontinued From Study Drug Due to Meeting Hemodynamic Stopping Rules|Hemodynamic criteria for stopping drug dosing were applied (any of the following, obtained resting and if present for ≥1 hour, unless noted). For all Panels: HR >120 bpm; SBP ≥180 mm Hg (Panels A-D/G-J) and ≥175 mm Hg (Panels E-F); DBP ≥110 mm Hg; DBP <50 mm Hg; SBP <90 mm Hg or participant placed in Trendelenburg position. For Panels A-H: HR increase over identified baseline of ≥25 beats per minute; SBP reduction >30 mm Hg versus identified baseline; >20 mm Hg drop in SBP and >20 beats per minute rise in HR observed together versus identified baselines; >30 mm Hg drop in orthostatic SBP and >30 beats per minute rise in orthostatic HR observed together. For Panels I-J, any of the following-down dosing criteria if still present 24 hours after dose decrease: HR increase ≥20 beats per minute versus identified baseline; SBP reduction >30 mm Hg versus identified baseline; SBP <100 mm Hg; >30 mm Hg drop in orthostatic SBP and >30 beats per minute rise in orthostatic HR observed together.|Up to 28 days|All participants who received at least one dose of study drug|||participants|||Number
2652066|NCT01656408|Primary|Number of Participants With an Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE. The 8 crossover Panel H participants are represented in both Panel H - MK-8150 10/20 mg column and Placebo (Panel A - J) column.|Up to 14 days after the last dose (Up to approximately 42 days, excluding pre-dose/screening period)|All participants who received at least one dose of study drug|||participants|||Number
2652068|NCT01656395|Secondary|Percentage of Participants With a ≥0.5 Change From Baseline in ACQ Score|The ACQ is a validated 6-item measure of asthma control to evaluate asthma control in response to therapy. Participants evaluate their asthma over the previous week by answering 6 questions: How often were you woken by your asthma during the night? How bad were your asthma symptoms when you woke up in the morning? How limited were you in your activities because of your asthma? How much shortness of breath did you experience because of your asthma? How much of the time did you wheeze? How many puffs/inhalations of short-acting bronchodilator have you used each day? Each response to a question was scored on a 7-point scale (0=best to 6=worst). The ACQ score is the average of the scores for the 6 items. The percentage of participants who experienced a ≥0.5 decrease in ACQ Score at Week 12 compared to Baseline was calculated using the MN method.|Baseline and Week 12|TH2-High participants who received ≥1 study drug dose and had ACQ data at Week 12.|||Percentage of participants|||Number
2652069|NCT01656395|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Score|The ACQ is a validated 6-item measure of asthma control to evaluate asthma control in response to therapy. Participants evaluate their asthma over the previous week by answering 6 questions: How often were you woken by your asthma during the night? How bad were your asthma symptoms when you woke up in the morning? How limited were you in your activities because of your asthma? How much shortness of breath did you experience because of your asthma? How much of the time did you wheeze? How many puffs/inhalations of short-acting bronchodilator have you used each day? Each response to a question was scored on a 7-point scale (0=best to 6=worst). The ACQ score is the average of the scores for the 6 items. Change from baseline to Week 12 in ACQ was estimated using a cLDA model. In the cLDA analysis, the Baseline value was the last measurement taken prior to the first double-blind study drug and the post-baseline value was calculated as the average ACQ Score at Week 12.|Baseline and Week 12|TH2-High participants who received ≥1 study drug dose and had ACQ data.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2652070|NCT01656395|Secondary|Percentage of Participants With a ≥0.5 Change From Baseline in AQLQ(S) Overall and Domain Scores|The AQLQ(S) is a 32-item questionnaire with questions on 4 domains (asthma symptoms, activity limitation, emotional function and environmental stimuli) over the previous 2 weeks. Responses were scored on a 7-point scale (1=worst to 7=best). Each domain score is defined as the average score of all answered questions in that domain. The AQLQ(S) Overall Score is defined as the average of all available item scores (1=worst to 7=best). The percentage of participants who experienced a ≥0.5 increase in AQLQ(S) Overall and Domain Scores at Week 12 compared to baseline was calculated using the Miettinen and Nurminen (MN) method. Statistical analyses are provide for the AQLQ(S) Overall Score response rate only.|Baseline and Week 12|TH2-High participants who received ≥1 study drug dose and had AQLQ(S) data at Week 12.|||Percentage of participants|||Number
2652071|NCT01656395|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire With Standardised Activities [AQLQ(S)] Overall and Domain Scores|The AQLQ(S) is a 32-item questionnaire with questions on 4 domains (asthma symptoms, activity limitation, emotional function and environmental stimuli) over the previous 2 weeks. Responses were scored on a 7-point scale (1=worst to 7=best). Each domain score is defined as the average score of all answered questions in that domain. The AQLQ(S) Overall Score is defined as the average of all available item scores (1=worst to 7=best). The changes from baseline are presented for the overall scores and the individual domain scores. Baseline was the last measurement taken prior to the first double-blind study drug. The ending values were calculated as the average AQLQ(S) Overall Score and domain scores at Week 12 of a 12-week treatment period. Statistical analyses are provided for the AQLQ(S) Overall Scores only.|Baseline and Week 12|TH2-High participants who received ≥1 study drug dose and had AQLQ(S) data.|||Score on a scale||Standard Deviation|Mean
2652072|NCT01656395|Secondary|Average Change From Baseline in Morning/Evening Peak Expiratory Flow (AM/PM PEF)|PEF was defined as a person's maximum speed (rate) of expiration as measured with a peak flow meter in liters per minute. Participants performed triplicate PEF measurements twice daily using a PEF meter, in the AM upon rising and in the PM immediately before study drug administration at bedtime. All three values were recorded and the average of the best morning PEF and the best evening PEF for each day (AM/PM) was determined through the e-Diary. The average change from Baseline in AM/PM PEF over the last 6 weeks of a 12-week treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a cLDA model. In the cLDA analysis, baseline was the average AM/PM PEF value during the placebo run-in period and the post-baseline value was calculated as the average AM/PM PEF over Week 6 to Week 12.|Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)|TH2-High participants who received ≥1 study drug dose and had AM/PM PEF data.|||Liters/minutes||95% Confidence Interval|Least Squares Mean
2652073|NCT01656395|Secondary|Average Change From Baseline in Number of Nocturnal Awakenings|"The number of nights per week (between consecutive visits) that a participant awakened with asthma was based on eDiary entries and was calculated by dividing the number of nights a participant awakened with asthma (positive responses of once, more than once, awake all night) by the total number of nights (all responses) and then multiplying by 7 (standardized to a 7-day period). The average change from baseline in number of nocturnal awakenings over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a cLDA model. In the cLDA analysis, baseline was the average number of nocturnal awakenings during the placebo run-in period and the post-baseline value was calculated as the average number of nocturnal awakenings over Week 6 to Week 12."|Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)|TH2-High participants who received ≥1 study drug dose and had nocturnal awakening data.|||Number of awakenings||95% Confidence Interval|Least Squares Mean
2652074|NCT01656395|Secondary|Average Change From Baseline in Use of Short-Acting Beta-Agonists (SABAs)|Twice daily (upon arising and before going to sleep), participants recorded the total number of puff (actuations) of SABA used for asthma symptoms in their eDiaries. The number of SABA puffs used in one day was calculated based on eDiary entries as the sum of daytime and nighttime number of puffs of SABA. The average change from baseline over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) in the daily number of SABA puffs was estimated using a cLDA model. In the cLDA analysis, Baseline was the average number of SABA puffs used in one day during the placebo run-in period and the post-baseline value was calculated as the average number of SABA puffs used in one day over Week 6 to Week 12.|Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)|TH2-High participants who received ≥1 study drug dose and had SABA usage data.|||Number of SABA Puffs||95% Confidence Interval|Least Squares Mean
2652075|NCT01656395|Secondary|Average Change From Baseline in Daytime Symptom Score (DSS)|The Daytime Symptom Score assessed daytime asthma symptoms. In the evening just before going to bed, participants scored their asthma symptoms for the period since arising by answering the following 4 questions in eDiaries: 1) How often did you experience asthma symptoms today?, 2) How much did your asthma symptoms bother you?, 3) How much activity could you do today? and 4) How often did your asthma affect your activities today? The 4 questions were scored on a 7-point scale (0=best to 6=worst) and averaged for a single score. The average change from baseline in DSS over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a cLDA model. In the cLDA analysis, baseline was the average DSS score during the placebo run-in period and the post-baseline value was the average DSS Score over Week 6 to Week 12.|Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)|TH2-High participants who received ≥1 study drug dose and had DSS data.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2652076|NCT01656395|Secondary|Percentage of Asthma Exacerbation Days|"An asthma exacerbation day was defined as a day with ANY of the following: a decrease from Baseline in morning (AM) Peak Expiratory Flow (PEF) of more than 20%, an AM PEF of less than 180 liters (L)/min, an increase in Short Acting Beta2 Agonist (SABA) use of more than 70% (and a minimum increase of at least 2 puffs), an increase from Baseline in Daytime Asthma Symptom Score of more than 50%, an overnight asthma symptom of: Awake all night, or an asthma attack. Information on asthma exacerbation days was recorded throughout the study in the participant's electronic diary (e-Diary), and an Analysis of Variance (ANOVA) was used to calculate the average percentage of days with asthma exacerbations over Week 6 to Week 12."|Week 6 to Week 12|TH2-High participants who received ≥1 study drug dose and had asthma exacerbation data.|||Percentage of Asthma Exacerbation Days||95% Confidence Interval|Least Squares Mean
2652077|NCT01656395|Primary|Percentage of Participants Who Discontinue Study Due to AEs|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE.|Up to 14 weeks|All randomized participants who received ≥1 dose of study drug.|||Percentage of participants|||Number
2652078|NCT01656395|Primary|Percentage of Participants Who Experience Adverse Events (AEs)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the study drug, is also an AE.|Up to 14 weeks|All randomized participants who received ≥1 dose of study drug.|||Percentage of participants|||Number
2652079|NCT01656395|Primary|Average Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)|FEV1 is the amount of air (in liters) forcibly exhaled in one second. Repeated measurements of FEV1 were collected at visits during the 12 week active treatment period and the average change from baseline in FEV1 over the last 6 weeks of the 12-week-treatment period (visits at Week 6, Week 8, Week 10 and Week 12) was estimated using a constrained longitudinal data analysis (cLDA) model. In the cLDA analysis, baseline was the average FEV1 during the placebo run-in period and the post-baseline value was the average FEV1 over Week 6 to Week 12.|Baseline and last six weeks of treatment (visits at Week 6, Week 8, Week 10 and Week 12)|T helper cell type 2 (TH2)-High participants who received ≥1 study drug dose and had FEV1 data.|||Liters||95% Confidence Interval|Least Squares Mean
2652080|NCT01656304|Secondary|Time to Distant Metastatic Disease|Time to distant metastatic disease using the Kaplan-Meier method|Every 3 months||||months||90% Confidence Interval|Median
2652081|NCT01656304|Secondary|The Change in PSA Velocity With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer|PSA velocity with bevacizumab therapy in androgen independent non-metastatic prostate cancer pre-therapy, as well as, PSA velocity with bevacizumab therapy while on therapy.|Baseline, every 6 weeks while on therapy, and then every 3 months thereafter||||ng/ml/month||Full Range|Median
2652082|NCT01656304|Secondary|Overall Survival of Androgen Independent Non-metastatic Prostate Cancer Patients Treated With Bevacizumab|Overall survival of androgen independent non-metastatic prostate cancer patients treated with bevacizumab. The number of patients still alive at the end of the study (median K-M estimate cannot be obtained due to the 86.7% censoring rate).|Every 3 months||||Participants|||Count of Participants
2652083|NCT01656304|Primary|Time to PSA Progression (TTPP)|TTPP will be measured from protocol registration to appearance of PSA progression as defined by the criteria of the PSA Working Group response criteria. The end point for progression will be calculated at the time a 25% increase in PSA has been achieved. PSA velocity will also be calculated as change in PSA doubling time pre and post therapy and the rate of PSA rise pre- and post-therapy.|An average every 6 weeks for up to 3 months||||months||90% Confidence Interval|Median
2652084|NCT01656304|Primary|Toxicities Associated With Bevacizumab Therapy|Toxicity rates will be summarized by point estimates and Wilson type 90% confidence intervals. Toxicities will be graded per the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), and PSA response will be determined as per PSA Working Group response criteria. Censored time to PSA progression will be estimated with standard Kaplan-Meier methodology.|An average of every 2 weeks while on therapy||||participants|||Number
2652085|NCT01656304|Primary|PSA Response Rate With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer|A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy. Response rates will be summarized by point estimates and Wilson type 80% confidence intervals.|An average every 6 weeks for up to 3 months||||participants|||Number
2652086|NCT01656252|Other Pre-specified|Exploratory- Eltrombopag Effect on TPO/EPO|To determine if eltrombopag has an effect on TPO and/or EPO in this setting.|62 months|||||||
2652087|NCT01656252|Secondary|Phase II- Safety of Eltrombopag With Consolidation|To determine the safety and tolerability of eltrombopag when given at the optimal dose in the setting of consolidation chemotherapy.|62 months|||||||
2652088|NCT01656252|Secondary|Phase II- Duration of Platelet Nadir|To determine the duration of platelet nadir in the setting of eltrombopag exposure.|62 months|||||||
2652097|NCT01656252|Primary|Phase I- Optimal Tolerated Dose of Eltrombopag|To determine the safety, tolerability and optimal dose of eltrombopag in acute myeloid leukemia patients in complete remission receiving intensive consolidation chemotherapy. The optimal dose was based on rules involving observation of Dose Limiting Toxicity (DLT events), defined as a CTCAE Version 4 non-hematologic adverse event of grade 3 or higher occurring within 30 days of the last dose of eltrombopag judged by the investigator to be at least possibly related to eltrombopag administration.|13 months||||mg|||Number
2652098|NCT01656200|Secondary|Number of Participants Reporting Adverse Events (Graded in Severity 1-4).||one month||||Participants|||Count of Participants
2652099|NCT01656200|Secondary|Neutralizing Antibody Titres to Live Attenuated JE SA-14-14-2 Vaccine at Week 4 Post Vaccination.|Neutralizing antibody titres (measured by 50% Plaque reduction neutralisation titre (PRNT50)) at 4 weeks post vaccination|4 weeks|1 participant withdrew before the 4 week time point, for another the sample was not available for analysis.|||Neutralising antibody titres||Full Range|Geometric Mean
2652100|NCT01656200|Primary|Change of T Lymphocyte Responses to Live Attenuated JE SA-14-14-2 Vaccine at Week 2.|Interferon gamma (IFNγ) spot forming cells (SFC)/million peripheral blood mononuclear cells (PBMC) at week 2 (peak response)|Week 1, week 2, week 4, week 8, 6 months|15 participants had data available at the two week time point. 1 withdrew beforehand, 1 declined to donate thew two week blood sample.|||IFNγ SFC/million PBMC||Full Range|Geometric Mean
2652101|NCT01656187|Primary|Hopkins Verbal Learning Test-Revised (HVLT-R) Total Score|"Hopkins Verbal Learning Test-Revised (HVLT-R) is a word memory test that contains 12 nouns that are read to a participant for three consecutive trials. After each trial, a participant is asked to recall the words that were read to them. The number of words recalled on each trial is summed together to produce a total score. The total score (higher score means a better outcome) is converted to a standardized T score using normative data. The possible T score for each participant ranges from 20 to 80, with higher scores indicative of a better outcome."|Baseline and 24 weeks|All participants who received at least one dose of each intervention and completed all study visits were included in the analysis. Participants who dropped out during the washout period (between Weeks 24-28) did not receive the second intervention and were not included in the analysis.|||units on a scale||Standard Deviation|Mean
2652102|NCT01656161|Secondary|Triptorelin PK Metrics for Both Injections: Concentration 0 Hour||Days 1-169 and Days 169-337|Participants in the PK/PD subset with a measured value.|||ng/mL||95% Confidence Interval|Geometric Mean
2652103|NCT01656161|Secondary|Triptorelin PK Metrics for Both Injections: Cmax||Days 1-169 and Days 169-337||||ng/mL||95% Confidence Interval|Geometric Mean
2652104|NCT01656161|Secondary|Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC)||Days 1-169 and Days 169-337||||days * ng/mL||95% Confidence Interval|Geometric Mean
2652105|NCT01656161|Secondary|Testosterone PD Metrics for First Injection: Time to Castration (Tcast)||Days 1-169||||days||95% Confidence Interval|Geometric Mean
2652106|NCT01656161|Secondary|Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)||Days 1-169|PK/PD subset of 15 participants|||hours||95% Confidence Interval|Median
2652107|NCT01656161|Secondary|Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)||Days 1-169||||nmol/L||95% Confidence Interval|Geometric Mean
2652108|NCT01656161|Secondary|Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)||Days 1-169||||day*nmol/L||95% Confidence Interval|Geometric Mean
2652109|NCT01656161|Secondary|"Number of Participants Who Presented a Real Acute-on-chronic (AOC) Phenomenon (Testosterone Levels ≥ 1.735 Nmol/L 48 Hours After the Second Injection While Previously Castrated)"||Day 171||||participants|||Number
2652110|NCT01656161|Secondary|Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337||Baseline through Day 337|ITT population with a measured value at each specified time point|||percentage of change in PSA levels||Standard Deviation|Mean
2652111|NCT01656161|Secondary|Percentage of Participants Showing ≤ 1.0 IU/L Increase in Serum Luteinising Hormone (LH) From 0 Hour to 2 Hours Post-injection on Day 1 and Day 169||on Days 1 and 169|Intention to treat (ITT) population with a measured value at the time analysed|||percentage of participants||95% Confidence Interval|Number
2652112|NCT01656161|Primary|Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)||within 337 days|Intention to treat population|||Percentage of Participants||95% Confidence Interval|Number
2652113|NCT01656031|Primary|Measure Patient Response to High-dose Cytarabine Followed by Clofarabine in Adult Patients With Relapsed or Refractory AML|Response to the therapy is measured by a defined improvement in Neutrophil and platlet counts, along with improved cellularity of bone marrow biopsy (>20% with maturation of all cell lines), <5% blasts, auer rods must not be detectable and extramedullary leukemia or soft tissue involvment must not be present.|5 weeks||||participants|||Number
2652114|NCT01655901|Secondary|Levels of Appetite-related Hormones|Profiles of glucose, insulin, cortisol, leptin, and ghrelin assessed at every 10 minutes during each 1-hour experimental condition.|1 hour|Not analyzed due to lack of funds (major budget cut)||||||
2652115|NCT01655901|Secondary|Stress Marker|Mental effort assessed on a visual analogue scale (100 mm in length). It ranges from 0 mm (no mental effort at all) to 100 mm (extremely mentally challenging).|1 day||||mm||Standard Deviation|Mean
2652116|NCT01655901|Secondary|Appetite Sensation|Visual analogue scale to assess appetite feelings. The scale is 100 mm in length and ranges from 0 mm (not hungry at all) to 100 mm (extremely hungry).|1 day||||mm||Standard Deviation|Mean
2652117|NCT01655901|Primary|Energy Intake and Energy Expenditure (Over 24 Hours and Over 3 Days)|Energy intake (kJ) was measured using an ad libitum test meal immediately following the 3 experimental conditions, a food menu for the remainder of the day, and a dietary record for the subsequent 3-day period. Energy expenditure was measured by indirect calorimetry during the 3 experimental conditions, and by using an Actical accelerometer for the subsequent 3-day period.|Acute (24 hours) and short-term (3 days)||||kJ||Standard Error|Mean
2652452|NCT01652573|Secondary|Area Under the Curve for TmP/GFR|TmP/GFR will be measured 0 to 24 hours postdose during a 24 hr admission at 3 months and AUC calculated and compared to baseline.|Time 3 months||||mg/100 ml GF*hr||95% Confidence Interval|Least Squares Mean
2652453|NCT01652573|Secondary|Number of Patients With Nasal Congestion at Baseline|This symptom will be assessed at baseline|Time 0||||Participants|||Count of Participants
2652118|NCT01655823|Primary|Change From Baseline in Patient Reported Outcome for Pain at Day 22 to Day 28.|The primary efficacy endpoint for Part I was the change from baseline in weekly average NPRS scores at 22 to 28 days after treatment. Baseline was defined as the average of NPRS scores for the last 7 days prior to dosing. Pain was assessed using a Numerical Pain Rating Scale (NPRS) with a range of 0 (no pain) to 10 (extreme pain).|Day 22 to Day 28|ITT|||11 point units on a scale||Standard Deviation|Mean
2652119|NCT01655719|Other Pre-specified|Lipid Accumulation in Tumor|Determine (by MRI) if pioglitazone induces lipid accumulation in follicular-patterned thyroid carcinomas that contain the PAX8-PPARgamma fusion gene.|24 weeks|||||||
2652120|NCT01655719|Other Pre-specified|Sensitization to Radioiodine Therapy|Determine if pioglitazone induces a clinically significant level of radioiodine uptake in the residual thyroid carcinoma, and if so, whether there is a therapeutic response to radioiodine. This will be addressed in a separate follow-up protocol available to subjects completing this study.|24 weeks|||||||
2652121|NCT01655719|Other Pre-specified|Biomarkers|Define predictive markers of response or insensitivity to pioglitazone. Unstained tumor tissue slides from archival paraffin blocks, fresh biopsy specimens from measurable metastases, and blood samples (serum and peripheral blood cells) will be collected on enrolled patients who consented for the optional correlative studies. These will be used to identify factors that predict efficacy of pioglitazone. Analyses may include measures of expression of specific RNAs and proteins, and DNA sequence analysis.|24 weeks|||||||
2652122|NCT01655719|Secondary|Toxicity|Toxicities experienced by patients with PAX8-PPARgamma fusion gene-positive follicular-patterned thyroid carcinomas treated with pioglitazone are indicated by presence of Serious Adverse Events (that show relatedness).|24 weeks||||serious adverse events|||Number
2652123|NCT01655719|Secondary|Change in Serum Thyroglobulin|Determine if pioglitazone decreases serum thyroglobulin in patients with follicular-patterned thyroid carcinomas that contain the PAX8-PPARgamma fusion gene.|Baseline and 24 weeks||||ng/mL|||Number
2652124|NCT01655719|Primary|Tumor Response (Change)|Response is measured by change in Tumor size (cm)|Baseline and 24 weeks||||cm|||Number
2652125|NCT01655563|Secondary|Clinical Adverse Events|The effect of pharmacogenetic dosing of tacrolimus for 48 hours on the frequency clinical adverse effects over 30±3 days.|Over 30 days, +/- 3 days|The overall number of participants analyzed was 53. A total of 7 patients (4 from genotype-guided dosing arm and 3 from standard dosing arm) began but did not complete 36- 48 hours of study dosing and were analyzed in their original assigned groups in an intention-to- treat model.|||adverse events|||Number
2652126|NCT01655563|Primary|Time to Maintain Stable Therapeutic Trough Concentrations|Defined as two consecutive concentrations at least 48 hours apart in the therapeutic range without any changes in tacrolimus dose|From Baseline to 30 days post-dose|The overall number of participants analyzed was 53. A total of 7 patients (4 from genotype-guided dosing arm and 3 from standard dosing arm) began but did not complete 36- 48 hours of study dosing and were analyzed in their original assigned groups in an intention-to- treat model.|||days||Inter-Quartile Range|Median
2652127|NCT01655563|Primary|Time to Achieve Therapeutic Tacrolimus Drug Concentrations|The primary outcome (efficacy) was time to achieve therapeutic tacrolimus trough concentrations|From Baseline to 30 days post-dose|The overall number of participants analyzed was 53. A total of 7 patients (4 from genotype-guided dosing arm and 3 from standard dosing arm) began but did not complete 36- 48 hours of study dosing and were analyzed in their original assigned groups in an intention-to- treat model.|||Days||Inter-Quartile Range|Median
2652128|NCT01655498|Secondary|Device-related Adverse Events|The number of overall adverse events rated as probably or definitely related to the study device.|1month|All subjects who were exposed to the VBC device (now called Eclipse) during the Treatment Period.|||events|||Number
2652129|NCT01655498|Secondary|Number of Incontinent Days|Change in number of incontinent days while wearing the device during the 2-week assessment period as compared to the baseline 2-week assessment period|1 Month||||days||Standard Deviation|Mean
2652130|NCT01655498|Primary|Frequency of FI Episodes|Subjects with at least a 50% reduction in FI episodes (major or minor soiling)|1 Month|Subjects who were successfully fit with the VBC device.|||percentage of participants|||Number
2652131|NCT01655381|Secondary|Percentage of Participants With Clinically Meaningful Improvement From Baseline in HAQ-DI|"Clinically meaningful improvement was defined as an improvement in HAQ-DI score of ≥0.22.~HAQ-DI is the participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty."|Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||percentage of participants|||Number
2652132|NCT01655381|Secondary|Percentage of Participants With Health Assessment Questionnaire Disability Index (HAQ-DI) Remission|"HAQ-DI remission was defined as HAQ-DI score <0.5.~HAQ-DI is the participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty."|Baseline and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||percentage of participants|||Number
2652133|NCT01655381|Secondary|Physicians' Global Assessment of Disease Activity (VAS) Score|The physicians' global assessment of disease activity (VAS) was assessed using a 100-mm horizontal VAS with 0=no disease activity to 100=maximum disease.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||units on a scale||Full Range|Median
2652134|NCT01655381|Secondary|Participants' Global Assessment of Disease Activity (VAS) Score|The participants' global assessment of disease activity (VAS) was assessed using a 100-mm horizontal VAS with 0=no disease activity to 100=maximum disease.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||units on a scale||Full Range|Median
2652135|NCT01655381|Secondary|Participants' Global Assessment of Pain (VAS) Score|The participants' global assessment of pain (VAS) was assessed using a 100-mm horizontal VAS with 0=no pain to 100=maximum pain.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||units on a scale||Full Range|Median
2652136|NCT01655381|Secondary|C-reactive Protein (CRP) Level|C-reactive protein (CRP) is a blood test marker for inflammation in the body. Normal CRP levels are below 5 milligrams per liter (mg/L). Higher scores correspond to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||mg/L||Full Range|Median
2652137|NCT01655381|Secondary|Erythrocyte Sedimentation Rate (ESR) Over Time|ESR is an direct measure of how much inflammation is in the body. The normal range is 0-22 mm/hour for men and 0-29 mm/hour for women. Higher scores correspond to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||mm/hour||Full Range|Median
2652138|NCT01655381|Secondary|Change From Day 1 in Swollen Joint Count Based on 28 Joints (SJC28) Over Time|The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28 swollen joints. Higher scores correspond to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||swollen joints||Standard Deviation|Mean
2652139|NCT01655381|Secondary|Change From Day 1 in Tender Joint Count Based on 28 Joints (TJC28) Over Time|The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28 tender joints. Higher scores correspond to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||tender joints||Standard Deviation|Mean
2652140|NCT01655381|Secondary|Change From Day 1 in Simplified Disease Activity Index (SDAI) Scores Over Time|SDAI was calculated using SJC28, TJC28, C-reactive protein (CRP) (milligrams per liter (mg/L)), and the patient's global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||units on a scale||Standard Deviation|Mean
2652141|NCT01655381|Secondary|Change From Day 1 in DAS28-ESR Scores Over Time|DAS28-ESR was calculated using Swollen Joint Count Based on 28 Joints (SJC28), Tender Joint Count Based on 28 Joints (TJC28), ESR (mm/hour) and patient's global assessment of disease activity (100-millimeter (mm) horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity.|Day 1 and Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, 116, 128, 140|The included population includes all participants who entered the study. All included participants were part of safety population. Here, n = number of participants who were evaluable at specific time points.|||units on a scale||Standard Deviation|Mean
2652142|NCT01655381|Secondary|Time to RA Flare Following Remission or Drug-Free Remission|Time to RA flare was defined as period of clinical remission or drug-free remission followed by flare of DAS28-ESR (increase in DAS28-ESR from the previous available visits of >1.2, or >0.6 if current DAS28-ESR ≥3.2). In the case of several remission periods for the same participant, the largest period was used.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.|||days||Full Range|Median
2652143|NCT01655381|Secondary|Percentage of Participants With at Least 1 Rheumatoid Arthritis (RA) Flare|An RA flare was defined as an increase in DAS28-ESR from the previous available visits of >1.2, or >0.6 if current DAS28-ESR ≥3.2. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.|||percentage of participants|||Number
2652144|NCT01655381|Secondary|Cumulative Time of Remission Per Participant Over the Extension Study Period|Clinical remission was defined as DAS28-ESR <2.6 and/or SDAI ≤3.3 for a period of at least two consecutive assessment visits (every 12 weeks) over the extension study period. DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity. SDAI scores range from 0 to 86, where lower scores indicate less disease activity.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.|||days||Full Range|Median
2652145|NCT01655381|Secondary|Percentage of Participants With at Least One Drug-Free Period|Drug-free remission period was defined as clinical remission for at least 2 consecutive assessment visits (every 12 weeks) AND without tocilizumab administration during this clinical remission period.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.|||percentage of participants|||Number
2652454|NCT01652573|Secondary|Area Under the Curve for 1,25(OH)2vitamin D|Serum 1,25(OH)2vitamin D will be measured 0 to 24 hours post dose during a 24 hr admission and AUC calculated.|Time 0||||ng/ml*hr||95% Confidence Interval|Least Squares Mean
2652146|NCT01655381|Secondary|Percentage of Participants With at Least One Clinical Remission Period|Clinical remission: Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) less than (<)2.6 and/or Simplified Disease Activity Index (SDAI) less than or equal to (≤)3.3 for a period of at least two consecutive assessment visits (every 12 weeks) over the extension study period. DAS28-ESR was calculated using Swollen Joint Count Based on 28 Joints (SJC28), Tender Joint Count Based on 28 Joints (TJC28), ESR (mm/hour) and patient's global assessment of disease activity (100-millimeter (mm) horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity. DAS28-ESR scores range from 0-10, with higher scores corresponding to greater disease activity. SDAI was calculated using SJC28, TJC28, C-reactive protein (CRP) (milligrams per liter (mg/L)), the patient's global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0-86, where lower scores indicate less disease activity.|Up to approximately 148 weeks|The included population includes all participants who entered the study. All included participants were part of safety population.|||percentage of participants|||Number
2652147|NCT01655381|Primary|Percentage of Participants With Any Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any AE that is fatal; life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect in a neonate/infant or significant medical event in the Investigator's judgment. AE of special interest (AESI) includes serious and/or medically significant infectious; myocardial infarction(MI) / acute coronary syndrome (ACS); gastrointestinal (GI) perforation; anaphylaxis / hypersensitivity reactions; demyelinating disorders; stroke; serious and/or medically significant bleeding events; serious and/or medically significant hepatic events; malignancies malignant.|Up to 160 weeks|Safety population is defined as all included participants who received having at least one tocilizumab administration.|||percentage of participants|||Number
2652148|NCT01655329|Other Pre-specified|Likert-Like|Following the viewing of the test radiographs, the radiologists were asked a series of questions of overall preference. On this scale, 1 indicates strong disagreement, 5 indicates strongly agree. Ten statements were used. Note that a low value for the standard image is equivalent to a high value for the modified image.|10 minutes|All 10 radiologist participants participated|||units on a scale||Standard Deviation|Mean
2652149|NCT01655329|Primary|Accuracy in Detecting the Tips of Tubes, Lines, and Wires.|Measurement of accuracy in determining the location of the tips of nasogastric tubes (NG) (various types of nasogastric tubes combined) and of the tips of venous catheters (various types of venous catheters combined), compared to the determination of the expert panel. Measure is the distance from the median location determined by five experts in chest radiology.|8 hours||||centimeters||Standard Error|Mean
2652150|NCT01655329|Primary|Time for Completion of Tasks|Time for completion of tasks of identifying the tips of tubes, lines, and wires. Outlying values are excluded from the calculation of the mean values and standard errors. Outlying values were defined as those more than three standard deviations from the mean time.|8 hours|Each radiologist interpreted only half (158) chest radiographs. All of the radiographs were interpreted by a combination of the 10 radiologist participants.|||seconds|Participants|Standard Error|Mean
2652151|NCT01655069|Secondary|Change From Baseline to Final Visit in Postvoid Residual (PVR) Volume|PVR volume was assessed by ultrasonography or bladder scan during 905-CL-076 and 905-CL-077. The value reported is the last PVR volume value after first dose of solifenacin up to 52 weeks.|Baseline (of 905-CL-076 study) to final Visit (the most recent value after first dose of solifenacin up to 40 weeks for participants who received placebo in 076 and 52 weeks for those who received solifenacin in 076.)|Safety Analysis Set (SAF). Participants who received placebo and participants who received solifenacin in Study 905-CL-076 are combined for analyses of efficacy and safety in this study.|||mL||Standard Deviation|Mean
2652152|NCT01655069|Secondary|Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents|Adolescent participants were also asked to record urgencies for at least 2 of the 7 diary days using the Perception of Intensity of Urgency Scale (PPIUS): (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). This data is based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.|Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment|Full Analysis Set (FAS) consisted of participants received at least one dose of open-label solifenacin and at least one of the efficacy variables with a valid baseline value and valid post-baseline data from diary completed after first dose of open-label solifencacin. Participants with available data at each time point are included in the analysis|||urgency episodes||Standard Error|Mean
2652153|NCT01655069|Secondary|Change From Baseline in Mean Number of Micturitions Per 24 Hours|The mean number of micturitions (urinations) was based on 7-day diary data completed by participants prior to each visit from start of 905-CL-076 to end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.|Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment|Full Analysis Set (FAS) consisted of participants received at least one dose of open-label solifenacin and at least one of the efficacy variables with a valid baseline value and valid post-baseline data from diary completed after first dose of open-label solifencacin. Participants with available data at each time point are included in the analysis.|||micturitions||Standard Error|Mean
2652187|NCT01654536|Secondary|Number of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||participants|||Number
2652154|NCT01655069|Secondary|Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days|The number of dry (incontinence-free) days was based on 7-day diary data completed by participants prior to each visit from start of 905-C L-076 to end of 905-C L-077. An incontinence-free day is a day without any incontinence episodes. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.|Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment|Full Analysis Set (FAS) consisted of participants received at least one dose of open-label solifenacin and at least one of the efficacy variables with a valid baseline value and valid post-baseline data from diary completed after first dose of open-label solifencacin. Participants with available data at each time point are included in the analysis.|||days||Standard Error|Mean
2652155|NCT01655069|Secondary|Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours|The mean number of incontinence episodes was based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. An Incontinence episode is defined as an episode with any involuntary loss of urine. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.|Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment|Full Analysis Set (FAS) consisted of participants received at least one dose of open-label solifenacin and at least one of the efficacy variables with a valid baseline value and valid post-baseline data from diary completed after first dose of open-label solifencacin. Participants with available data at each time point are included in the analysis.|||incontinence episodes||Standard Error|Mean
2652156|NCT01655069|Primary|Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs)|"The investigator assessed the severity of AEs, including abnormal clinical laboratory values, electrocardiogram (ECG), vital signs, as follows:~Mild: No disruption of normal daily activities; Moderate: Affect normal daily activities; Severe: Inability to perform daily activities. In participants treated with placebo in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of open-label solifenacin in Study 905-CL-077 up to 7 days after the last dose of solifenacin. In participants treated with solifenacin in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of double-blind solifenacin in Study 905-CL-076 up to 7 days after last dose of open-label solifenacin in Study 905-CL-077."|From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076).|Safety Analysis Set (SAF). Participants who received placebo and participants who received solifenacin in Study 905-CL-076 are combined for analyses of efficacy and safety in this study.|||Participants|||Count of Participants
2652157|NCT01655043|Primary|Quantification of Myocardial Blood Volume|The investigators anticipated that a novel MRI imaging protocol using a high relaxivity blood-pool contrast agent (gadofosveset trisodium) would be capable of quantifying coronary flow reserve based on quantification of myocardial blood volume and would be correlated with myocardial flow reserve as measured in low spatial resolution nuclear SPECT scans. Pre- and post- gadofosveset trisodium images were to be used to calculate the myocardial blood volume. Myocardial blood volume is derived from an equation of the relaxation times of hydrogen atoms in the blood and myocardium. If the agent administered did not behave as a true intravascular agent in the myocardium, quantification of myocardial intravascular blood volume (and hence a calculated coronary flow reserve) could not be calculated using the specified approach. In this case, relaxation times would be reported. Relaxation (R) times are measured in inverse seconds.|outcome measured following single MRI scan||||seconds^-1||Standard Deviation|Mean
2652158|NCT01654887|Primary|Percentage of Participants Whose Pneumonia Was Missed by LUS or CXR||week 1-2||||percentage of participants||95% Confidence Interval|Number
2652159|NCT01654887|Secondary|Comparison of the Length of Stay in the ED|Chart review conducted to assess overall LOS in the ED.|up to 5 hours||||minutes||Inter-Quartile Range|Median
2652160|NCT01654887|Secondary|Percentage of Participants Who Had Hospital Admission.|Chart review and follow up phone call made at 1-2 weeks to assess whether or not the subject was admitted during the index ED visit or at a later healthcare visit.|weeks 1-2||||percentage of participants||95% Confidence Interval|Number
2652161|NCT01654887|Secondary|Percentage of Participants With Antibiotic Use|A chart review and follow up phone call made at 1-2 weeks to assess whether or not the subject was started on antibiotics during the index Emergency Department (ED) visit or at a later healthcare visit.|weeks 1-2||||percentage of participants||95% Confidence Interval|Number
2652162|NCT01654887|Secondary|Comparison of Unscheduled Healthcare Visits|Percentage of participants who had unscheduled healthcare visits after the index Emergency Department visit between those subjects who undergo CXR first and those who undergo LUS first.|week 1-2||||percentage of participants||95% Confidence Interval|Number
2652163|NCT01654887|Primary|Percentage of Participants For Whom CXR Was Not Needed to Diagnose Pneumonia|The percentage of Participants For Whom CXR Was Not Needed (or received only lung US) to Diagnose Pneumonia. The primary objective of this study is to determine if it is possible for lung ultrasound (LUS) to replace chest x-ray (CXR) when evaluating patients with possible pneumonia. Specifically, an overall reduction of CXR when LUS is used first. Null hypothesis is that LUS cannot replace CXR for the diagnosis of pneumonia. Alternate hypothesis is that LUS can replace CXR for pneumonia.|up to 5 hours||||percentage of participants||95% Confidence Interval|Number
2652164|NCT01654861|Secondary|Anti-Tumor Response|CT and PET scans will be performed at baseline and then every two months. Target and Non-Target Lesions will be identified and recorded at baseline. When subsequent scans are performed, anti-tumor responses will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST).|Every 2 months for up to 6 months.|Data were not analyzed as the study was prematurely closed.||||||
2652188|NCT01654536|Secondary|Percentage of Subjects With Development of or Worsening in Lens Opacities.||0-6 months||||percentage of participants|||Number
2652189|NCT01654536|Secondary|Number of Subjects With Development of or Worsening in Lens Opacities.||0-6 months||||participants|||Number
2652165|NCT01654861|Primary|Adverse Events as a Measure of Safety and Tolerability|Adverse events, whether volunteered by the study subject, discovered by the investigators during questioning, or detected by physical examination, laboratory tests, or other means will be collected and recorded at each visit. Events will be recorded from the time the consent is signed until 4 weeks after the study protocol is discontinued. Subjects experiencing Grade 4 neutropenia, Grade ≥3 thrombocytopenia, or Grade 2 peripheral neuropathy who do not recover will have treatment protocol discontinued.|Weekly for up to 6 months.||||participants|||Number
2652166|NCT01654796|Primary|Hamilton Rating Scale for Depression - 6 Items|The total HAM-D-6 score is reported. The range of possible scores on the HAM-D-6 is from 0 to 22. Higher values indicate increased depression severity, and worse outcomes. This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week.The time frame for this scale is the past 24 hours.|Baseline and 48 hours after initiating treatment|Please note that while 85 subjects were randomized, only 84 subjects were included in the outcome analysis due to missing data.|||units on a scale||Standard Deviation|Mean
2652167|NCT01654666|Secondary|Serum S-100B Levels.||Baseline, on admission, and 1 and 24 hours after carotid artery stenting.|The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.|||pg/mL||Standard Deviation|Mean
2652168|NCT01654666|Secondary|Serum Neuron Specific Enolase (NSE) Levels.||Baseline, on admission, and 1 and 24 hours after carotid artery stenting.|The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.|||ng/L||Standard Deviation|Mean
2652169|NCT01654666|Secondary|Number of Patients With Any Side Effects of Remote Ischemic Preconditioning (RIPC) Treatment.|The side effects referred to any side effects of RIPC or sham RIPC treatment, not including the sides effect of medications and CAS.|From baseline to 6 months after treatment.||||participants|||Number
2652170|NCT01654666|Secondary|Serum High-sensitive C-reactive Protein (Hs-CRP).||Baseline, on admission, and 1 and 24 hours after carotid artery stenting.|The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.|||mg/L||Inter-Quartile Range|Median
2652171|NCT01654666|Primary|Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans.||Within 48 hours after carotid artery stenting.|The analysed population only included participants who finished carotid artery stenting, post-treatment MRI scans and blood drawn.|||participants|||Number
2652172|NCT01654666|Primary|Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death.|Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome. Cardiovascular events included angina and myocardial infarction.Death included any reason caused death.|Within six months after carotid artery stenting|The analysis population only included participants who fully completed the study.|||participants|||Number
2652173|NCT01654601|Secondary|Accumulation Rate of Clozapine in Plasma||Up tp 12hours||||ng/ml/hr||Standard Deviation|Mean
2652174|NCT01654601|Secondary|Terminal Half Life of Clozapine in Plasma||Up to 12hours||||hour||Standard Deviation|Mean
2652175|NCT01654601|Secondary|Time to Reach Maximum Concentration of Clozapine in Plasma||Up to 12hours||||hour||Standard Deviation|Mean
2652176|NCT01654601|Primary|Maximum Concentration of Clozapine in Plasma||Up to 12hours||||ng/mL||Standard Deviation|Mean
2652177|NCT01654549|Secondary|Anthropometric Measurements|Secondary outcome measure was change in anthropometric measurements (body mass index and waist circumference) from baseline to the end of study|8 weeks|||||||
2652178|NCT01654549|Secondary|Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)|Secondary outcome measure was change in HOMA-IR from baseline to the end of study|8 weeks|||||||
2652179|NCT01654549|Secondary|Serum Lipid Profile|Secondary outcome measure was change in serum lipid profile (including serum triglyceride, cholesterol, low-density lipoprotein, and high-density lipoprotein concentration) from baseline to the end of study|8 weeks|||||||
2652180|NCT01654549|Secondary|Fasting Serum Glucose|Secondary outcome measure was change in fasting serum glucose concentration from baseline to the end of study|8 weeks|||||||
2652181|NCT01654549|Secondary|Serum Aspartate Aminotransferase Level|Secondary outcome measure was change in serum aspartate aminotransferase concentration from baseline to the end of study|8 weeks|||||||
2652182|NCT01654549|Secondary|Serum Alanine Aminotransferase Level|Secondary outcome measure was change in serum alanine aminotransferase concentration from baseline to the end of study|8 weeks|||||||
2652183|NCT01654549|Primary|Liver Fat Content|"Primary outcome measure was changes in the liver fat content from baseline to the end of study (6 weeks post-treatment).~The percent of liver fat was calculated as below:~Liver fat content (%) = 10 (-0.805 + 0.282 * metabolic syndrome (yes = 1 / no = 0) + 0.078 * type 2 diabetes (yes =2 / no =0) + 0.525 * log fasting serum insulin (mU/L) + 0.521 * log fasting serum AST (U/L) - 0.454 * log (AST/ALT)"|8 weeks (6 weeks post-treatment)||||percentage of liver fat content||Standard Deviation|Mean
2652184|NCT01654536|Secondary|Percentage of Subjects With Change From Baseline in Best Corrected Visual Acuity.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||percentage of participants|||Number
2652185|NCT01654536|Secondary|Number of Subjects With Change From Baseline in Best Corrected Visual Acuity.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||participants|||Number
2652186|NCT01654536|Secondary|Percentage of Subjects With Increase ≥ 7 mm Hg From Baseline in Intraocular Pressure, or a Change to > 21 mm Hg, in Either Eye||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||percentage of partcipants|||Number
2652190|NCT01654536|Secondary|The Percentage of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||percentage of participants|||Number
2652191|NCT01654536|Secondary|The Number of Subjects Experiencing Treatment Emergent AEs Causing Study Medication Discontinuation.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||participants|||Number
2652192|NCT01654536|Secondary|The Percentage of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||percentage of participants|||Number
2652193|NCT01654536|Primary|The Percentage of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||percentage of participants|||Number
2652194|NCT01654536|Secondary|The Number of Subjects Experiencing Treatment Emergent Serious Adverse Events (SAEs).||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||participants|||Number
2652195|NCT01654536|Secondary|The Percentage of Subjects Experiencing Treatment Emergent AEs.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||percentage of participants|||Number
2652196|NCT01654536|Secondary|The Number of Subjects Experiencing Treatment Emergent AEs.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||participants|||Number
2652197|NCT01654536|Secondary|The Percentage of Subjects Experiencing Treatment Emergent Nasal AEs.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||percentage of participants|||Number
2652198|NCT01654536|Secondary|The Number of Subjects Experiencing Treatment Emergent Nasal AEs.||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||participants|||Number
2652199|NCT01654536|Primary|The Number of Subjects Experiencing Nasal Mucosal Disorders, Septum Disorders, or Nasal Septum Perforations as Treatment Emergent Adverse Events (AEs; TEAE)||0-6 months|Safety Population: The safety population consisted of all randomly assigned subjects who received at least 1 dose of study medication. The safety population was expected to be the same as the ITT population. However, if there were any subjects who were mis randomized, the actual treatment taken would have been used for the analyses.|||participants|||Number
2652200|NCT01654523|Primary|Mean Change in Massachusetts General Hospital Hairpulling Scale Baseline to Post-treatment|Measures severity of trichotillomania. Total score ranges from 0 (none) to 28 (severe). Mean change is determined by score at baseline minus score after treatment.|Baseline to post treatment; typically over 9 weeks||||Units on a scale||Standard Deviation|Mean
2652201|NCT01654380|Primary|Part B: Glycodynamics: Maximum Rate of Glucose Disposal|The maximum rate of glucose disposal (Rdmax) is presented. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.|Baseline, up to 10 hours (duration of the euglycemic glucose clamp)|Participants who received at least 1 dose of study drug with evaluable Rdmax data.|||milligrams/minute/kilograms (mg/min/kg)||Geometric Coefficient of Variation|Geometric Mean
2652202|NCT01654380|Primary|Part B: Glycodynamics: Glucose Disposal|"The fold change from baseline in glucose disappearance rate (GDR) is presented. The fold GDR increase from baseline was calculated by last 2 hours of GDR/basal GDR.~The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours."|Baseline, up to 10 hours (duration of the euglycemic glucose clamp)|Participants who received at least 1 dose of study drug with evaluable GDR data.|||fold change||Standard Deviation|Mean
2652203|NCT01654380|Primary|Part B: Glucodynamics: Endogenous Glucose Output|"The percent suppression from baseline in endogenous glucose production (EGP) is presented. Percent EGP change from baseline was calculated by (1-[last 2 hours of EGP/basal EGP])*100.~The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours."|Baseline, up to 10 hours (duration of the euglycemic glucose clamp)|Participants who received at least 1 dose of study drug with evaluable EGP data|||percent of suppression||Standard Deviation|Mean
2676982|NCT01435577|Secondary|Time to First Rescue Medication|The median time to first rescue medication intake (600 mg ibuprofen) in hours.|up to 48 hours|Full analysis set.|||hours||95% Confidence Interval|Median
2652204|NCT01654315|Secondary|Arm Motor Ability Test (AMAT)|"The Arm Motor Activity Test (AMAT) was the secondary outcome for this study and was used to determine whether changes occur in activity limitation. The AMAT is a 13-item test in which valued activities are rated according to a functional ability scale that examines affected limb use 0 = no use, 1 = very slight use, 2 = slight use, 3 = moderate use, 4 = almost normal use, 5 = normal use;) and a Quality of Movement Scale (0 = no use, 1 = very poor, 2 = poor, 3 = fair, 4 = almost normal, 5 = normal. ). Therefore, the highest score that one can attain on either scale is 65.0 (which would mean that the person scored a perfect score of 5 on each of the thirteen items)."|Administered twice before the intervention period. These two scores are averaged to provide a composite score that is compared to average score for each group that is collected 1 week after intervention||||units on a scale||Standard Deviation|Mean
2652205|NCT01654315|Primary|Impairment in the Affected Upper Extremity as Measured by the Fugl Meyer Scale.|"The upper extremity section of the Fugl-Meyer Scale (FM) will assess whether changes occur in paretic upper extremity motor impairment. The FM has been used extensively in stroke recovery studies, and is highly recommended for use in clinical trials designed to evaluate changes in motor impairment following stroke. The items on the measure require the subject to perform various movements with the affected upper extremity, and each item is scored from 0 (cannot perform) to 2 (performs normally). Item are then summed for a total score. The total score ranges are 0 to 66, with a higher score representing less upper extremity impairment (and, thus, a relatively better score on the measure than a lower score)."|Administered twice before the intervention period. These two scores are averaged to provide a composite score that is compared to average score for each group that is collected 1 week after intervention||||units on a scale||Standard Deviation|Mean
2652206|NCT01654302|Primary|Index Knee Pain Scores on a Numeric Rating Scale (NRS)|Subject rated index knee pain 5 minutes after stopped experimental exercise (with intervention). Index knee pain was reported using the Numeric Rating Scale, a scale from 0 to 10 where 0 = no pain and 10 = the worst pain possible.|5 minutes after stopped exercise, performed 1 hour after intervention (patch application)|Of the 40 subjects 2 were lost to follow-up, one from each group, making a total of 38 participants included in the analysis. Unfortunately, NRS data at 5 minutes post-exercise is missing for 2 subjects in the Synera treatment group and 1 subject in the Placebo group due to technical errors. The data was captured but we were unable to retrieve it.|||units on a scale||Standard Deviation|Mean
2652207|NCT01654289|Secondary|Pro-Inflammatory Cytokines|Laboratory-assessed objective measures will primarily serve to corroborate self-reports of disease severity. High sensitivity C-reactive protein (HS-CRP) is a well-established indicator of disease severity during respiratory infection, and can be measured in serum and in nasal wash.Concentrations of interleukin-6 (IL-6)and interleukin-8 (IL-8)in nasal wash have been shown to correlate with illness severity. More recently, interferon-gamma-induced protein 10 (IP-10) has been shown to be measurably increased in both serum and nasal wash during times of acute viral ARI. Biomarker levels were measured at the two standardized follow-up visits in December and March when participants were not ill.|Baseline, 4 months post-intervention (December) and 8 months post-intervention (March).|Obtained participant data reported.|||pg/mL||Full Range|Median
2652208|NCT01654289|Secondary|Blood Pressure|Standard brachial blood pressure will be assessed by trained nurses using calibrated sphygmomanometers.|Baseline and 8 months (exit from study)|Obtained participant data reported.|||mm Hg||Full Range|Mean
2652209|NCT01654289|Secondary|Body Mass Index (BMI)|Body habitus is associated with many disease processes, and may be related to immune function and susceptibility to respiratory infection. Height will be assessed at baseline only. Weight will be measured at baseline, 1 and 4 months post-intervention, and at exit. Baseline BMI will be calculated and used as a covariate in statistical models. BMI will also be considered a secondary outcome of potential importance.|Baseline and 8 months (exit from study)|Obtained participant data reported.|||kg/m2||Full Range|Mean
2652210|NCT01654289|Secondary|Pittsburgh Sleep Quality Index (PSQI)|"Sleep quality has been linked to several important quality of life and health outcomes. The PSQI is widely used and has been assessed for reliability and validity.In this study, improved sleep is a potential mediator of intervention effects, and a potentially important outcome on its own. The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a global score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality."|Baseline and 8 months (exit from study)|Obtained participant data reported.|||score on a scale||Full Range|Mean
2652211|NCT01654289|Secondary|Exercise Self-Efficacy Scale (ESES)|"Self-efficacy has been defined as the belief in one's capabilities to organize and execute the courses of action required to manage prospective situations. The ESES scale was developed based on work by Bandura and colleagues,and has been validated by Shin, Kroll,and Everett. For this study, the ESES will be used to verify results of the exercise intervention, and to help explain potential mediational effects of exercise. The total score is derived by summing the scores for the individual items; possible scores range from 0 to 180. Total score (out of 180) is sum of item scores. Higher score represents greater perceived self efficacy."|Baseline and 8 months (exit from study)|Obtained participant data reported.|||score on a scale||Full Range|Mean
2652212|NCT01654289|Secondary|Mindfulness-based Self Efficacy Scale (MSES)|"The MSES is one of the more recent questionnaires, developed by Cayoun and Freestun to assess effects of MBSR training on perceived self-efficacy. The MSES assesses 7 domains related to mindfulness self-efficacy, including behavior, cognition, interoception, affect, interpersonal, avoidance and mindfulness. The MSES will provide a nice counterpart to the ESES to help distinguish effects of interventions on ARI outcomes. The lower the score, the lower self-efficacy is in using mindfulness skills.~The current lack of psychometric data for the MSES renders the following ranges very tentative. They are currently only a rough clinical guide and scores must be interpreted with caution.~0-34 Poor sense of self-efficacy 35-69 Weak sense of self-efficacy 70-104 Moderate sense of self-efficacy 105-140 Good sense of self-efficacy"|8 months (exit from study)||||score on a scale||Standard Deviation|Mean
2652308|NCT01653262|Secondary|Number of Subjects Who Are Free From Nonpsychotic Behavioral Side Effects Over the Entire Treatment Period|Nonpsychotic behavioral side effects (NBSE) include (but are not limited to) such symptoms as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, etc.|From Visit 2 (Week 0) to Visit 6 (Week 12)|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.|||subjects|||Number
2652213|NCT01654289|Secondary|Perceived Stress Scale (PSS-10)|"The PSS-10 has been validated in multiple studies. PSS scores predict rates of viral infection among volunteers inoculated with rhinovirus, and correlate with physiologic and self-report indicators of ARI illness, including nasal IL-6 level. Because stress reduction is one of the hypothesized mechanisms of action, this study population will include working-age participants, who are presumed to be more stressed. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.~Scores ranging from 0-13 would be considered low stress.~Scores ranging from 14-26 would be considered moderate stress.~Scores ranging from 27-40 would be considered high perceived stress."|Baseline and 8 months (exit from study)|Obtained participant data reported.|||score on a scale||Full Range|Mean
2652214|NCT01654289|Secondary|SF-12|Also known as the Medical Outcomes Study Short Form, this 12-item questionnaire is commonly used to measure overall health, including physical (SF12-P) and mental health (SF12-M) subscales. It has been extensively assessed for reliability, responsiveness and criterion validity. In this study, it will be used to assess potential changes in general physical and mental health due to interventions, and as a covariate to control for baseline between-person differences in multivariate efficacy analyses. Physical and Mental Health Composite Scores are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Baseline and 8 months (exit from study)|Obtained participant data reported.|||score on a scale||Full Range|Mean
2652215|NCT01654289|Secondary|Health Care Utilization|"Cumulative total number of health care visits, ARI-related health care visits, and ARI-related prescriptions, including antibiotics and anti-influenza anti-virals will be documented. Each weekly communication will include the question, Have you seen a doctor or visited a clinic, hospital or urgent care center? Persons answering Yes will be asked the reason for the visit. Those answers will then be classified by blinded study personnel as either Related, or Unrelated to ARI illness, including upper respiratory infection, influenza, pharyngitis, acute sinusitis, bronchitis, and pneumonia."|8 months||||Total # ARI-related Medical visits|||Number
2652216|NCT01654289|Secondary|Absenteeism|Employment, including type of work, hours per week worked, and compensation, assessed as hourly wage, will be assessed at enrollment. Each week throughout the study participants will complete questions to assess number of hours of work missed. Study personnel blinded to allocation group status will assess and classify reasons for missed work as either ARI-related or not ARI-related. Presented as a total cumulative number of days missed of work due to an ARI-related event.|8 months||||Total # of ARI-related Missed Work days|||Number
2652217|NCT01654289|Primary|Severity-weighted Total Days of ARI Illness|The primary outcome will be severity-weighted total cumulative days of ARI illness (global severity), calculated as trapezoidal approximation to area under the time severity curve during ARI illness, with severity assessed once daily using self-reports on the validated Wisconsin Upper Respiratory Symptom Survey (WURSS-24). Incidence (number of ARI episodes in each group) and duration (total number of days of ARI illness) are components of the primary outcome, and will be analyzed separately.|8 months||||severity*days|||Number
2652218|NCT01654276|Primary|Urine pH||6 months||||pH||Standard Deviation|Mean
2652219|NCT01654276|Primary|Fractional Excretion UA||6 months||||% of serum uric acid excreted in urine||Standard Deviation|Mean
2652220|NCT01654276|Primary|Urine Creatinine||6 months||||mg/dl||Standard Deviation|Mean
2652221|NCT01654276|Primary|Urine Uric Acid||6 months||||mg/dl||Standard Deviation|Mean
2652222|NCT01654276|Primary|Serum Triglycerides||6 months||||mg/dl||Standard Deviation|Mean
2652223|NCT01654276|Primary|Serum HDL-cholesterol||6 months||||mg/dl||Standard Deviation|Mean
2652224|NCT01654276|Primary|Seum Total Cholesterol||6 months||||mg/dl||Standard Deviation|Mean
2652225|NCT01654276|Primary|Insulin Sensitivity Measured by HOMA (HOmeostasis Model Assessment)||6 months||||Homeostatic model assessment for Insulin||Standard Deviation|Mean
2652226|NCT01654276|Primary|Serum Insulin||6 months||||mU/L||Standard Deviation|Mean
2652227|NCT01654276|Primary|Serum Glucose||6 months||||mg/dl||Standard Deviation|Mean
2652228|NCT01654276|Primary|Ambulatory Diastolic Blood Pressure|Diastolic BP by ambulatory blood pressure monitor.|6 months||||mmHg||Standard Deviation|Mean
2652229|NCT01654276|Primary|Ambulatory Systolic Blood Pressure|Systolic BP by ambulatory blood pressure monitor.|6 months||||mmHg||Standard Deviation|Mean
2652230|NCT01654276|Primary|Serum Creatinine||6 months||||mg/dl||Standard Deviation|Mean
2652231|NCT01654276|Primary|Serum Uric Acid||6 months||||mg/dl||Standard Deviation|Mean
2652232|NCT01654276|Primary|BMI||6 months||||kg/m^2||Standard Deviation|Mean
2652233|NCT01654263|Secondary|Immunogenicity: Serotype-specific OPA Titer to 12 Vaccine Serotypes at Days 0 and 180 Post Vaccination.|Blood was collected from all participants at Days 0 and 180 after receipt of vaccination. The geometric mean for each group was then assessed by serotype-specific opsonophagocytic antibody (OPA).|Day 0 and Day 180 post vaccination|All participants who received vaccination and had immunology samples obtained within the protocol-defined windows for Days 0, 28, and 180 are included. Three additional subjects were excluded for not meeting eligibility criteria or receipt of a non-study vaccine. Data were analyzed regardless of age strata as pre-specified in the study protocol.|||Titer||95% Confidence Interval|Geometric Mean
2652234|NCT01654263|Primary|Geometric Mean Titers of Serotype-specific Opsonophagocytic Antibody (OPA) to 12 Vaccine Serotypes at Days 0 and 28 Post Vaccination.|Blood was collected from all participants at Day 0 and Day 28 after receipt of vaccination. The geometric mean for each group was then assessed by serotype-specific opsonophagocytic antibody (OPA).|Day 0 and Day 28 post vaccination|All participants who received vaccination and had immunology samples obtained within the protocol-defined windows for Days 0, 28, and 180 are included. Three additional subjects were excluded for not meeting eligibility criteria or receipt of a non-study vaccine. Data were analyzed regardless of age strata as pre-specified in the study protocol.|||Titer||95% Confidence Interval|Geometric Mean
2652455|NCT01652573|Secondary|Area Under the Curve for TmP/GFR|Serum phosphate will be measured 0 to 24 hours postdose during a 24 hr admission, AUC calculated, and fasting Tmp/GFR calculated.|Time 0||||mg/100 ml GF*hr||95% Confidence Interval|Least Squares Mean
2652235|NCT01654263|Primary|Number of Participants Reporting Vaccine-related Serious Adverse Events.|"Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof; was a congenital anomaly/birth defect; or may have jeopardized the participant, or required intervention to prevent one of the outcomes. Association with PCV13 was determined by the investigator and defined as Related, meaning there was a known temporal relationship, or the event was known to occur in association with study product or with a product in a similar class of study products and no alternate etiology was identified."|Up to Day 180 post vaccination|All participants who received vaccination are included. Data were analyzed regardless of age strata as pre-specified in the study protocol.|||participants|||Number
2652236|NCT01654263|Primary|Number of Participants Reporting Unsolicited Vaccine-related Adverse Events.|"Association with PCV13 was determined by the investigator and defined as Related, meaning there was a known temporal relationship, or the event was known to occur in association with study product or with a product in a similar class of study products and no alternate etiology was identified."|Up to Day 28 post vaccination|All participants who received vaccination are included. Data were analyzed regardless of age strata as pre-specified in the study protocol.|||participants|||Number
2652237|NCT01654263|Primary|Number of Participants Reporting Solicited Local and Systemic Adverse Events|Participants maintained a memory aid to record daily the occurrence of local injection site reactions and systemic reactions for 8 days after vaccination based on their interference with daily activities for subjective symptoms or quantitative measurement of the reaction. All participants reporting events of any severity (mild, moderate, or severe) are counted. For measured reactions, participants are included if the reaction is >0mm.|Days 0 to Day 7 post vaccination|All participants who received vaccination are included. Data were analyzed regardless of age strata as pre-specified in the study protocol.|||participants|||Number
2652238|NCT01654250|Other Pre-specified|Conners Parent Rating Scale (CPRS) Scores|CPRS was used to measure features associated with ADHD and was used to compare scores during the dose optimization period i.e. 1-6 weeks. The assessment was performed by parent or guardian. CPRS consisted of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true). Raw scores were converted to t-scores and t-scores have a mean of 50 ± 10 where higher scores are indicative of greater problems. The participant received normalized t-scores on the following scales: oppositional, cognitive problems/inattention, hyperactivity, anxious-shy, perfectionism, social problems, psychosomatic, ADHD index, restless-impulse, emotional liability, conner's global index, inattentive, hyperactive-impulsive and diagnostic and statistical manual of mental disorders IV (DSM-IV). This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.|Baseline, Day 8, 15, 22, 29, 36, 43|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
2652239|NCT01654250|Other Pre-specified|Clinical Global Impression-Improvement (CGI-I)|The CGI-I measured the participant's disease improvement relative to baseline as followed: 1= very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6= much worse, and 7=very much worse. This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.|Day 8, 15, 22, 29, 36, 43|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
2652240|NCT01654250|Other Pre-specified|Clinical Global Impression of Severity (CGI-S)|CGI-S scale was used to measure features associated with ADHD. The assessment was performed by the investigator of the study research team. The CGI-S classified the participant's current disease status as: 1 = normal, not at all ill, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill participants. This outcome measure was analyzed during open label phase in entire study population prior to randomization into two treatment groups.|Baseline, Day 8, 15, 22, 29, 36, 43|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
2652241|NCT01654250|Secondary|Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose|The PERMP score measured the manifestations of attention deficit hyperactivity disorder. The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10- minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure participant's performance. The total score range from 0-160 with higher scores indicating better performance.|0.75, 2, 4, 8, 10, 12 and 13 post-dose|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
2652242|NCT01654250|Secondary|Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose|SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. The SKAMP subscales were obtained by summing the individual items as follows: Attention (items 1-4) and Deportment (items 5-8), where each item was rated on a 7-point scale (0=normal to 6=maximal impairment). SKAMP attention subscale was reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment. SKAMP deportment subscale was reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment.|0.75, 2, 4, 8, 10, 12, 13 hours post-dose|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
2652456|NCT01652573|Primary|Area Under the Curve for FGF23|FGF23 will be measured 0 to 24 hours post dose during a 24 hour admission at 3 months and AUC calculated and compared to baseline.|3 months||||pg/ml*hr||95% Confidence Interval|Least Squares Mean
2652243|NCT01654250|Secondary|Onset and Duration of Clinical Effect|Onset and duration of clinical effect was determined using SKAMP combined rating scale at each post-dose time point. Onset of effect was defined as first assessment time showing statistical significance (i.e. p was less than or equal to [=<] 0.05) between NWP09 and placebo and duration of effect was defined as the as last consecutive time-point at which difference was statistically significant between NWP09 and placebo. SKAMP scale measured the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score was comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment.|0.75, 2, 4, 8, 10, 12, 13 hours post-dose|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.|||Units on a scale||Standard Deviation|Mean
2652244|NCT01654250|Primary|Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points|The SKAMP scale measured the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment. Average of all post dose SKAMP-combined scores measured at 0.75, 2, 4, 8, 10, 12 and 13 hours post-dose was calculated.|0.75 up to 13 hours post-dose|ITT population included all randomized participants who received at least 1 dose of double-blind study medication (either NWP09 or matching placebo) and had at least 1 post-baseline assessment of the primary efficacy variable.|||units on a scale||Standard Error|Least Squares Mean
2652245|NCT01654224|Primary|Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings|The primary objective of this study is to determine the noninferiority of high- dose inactivated influenza vaccine (HDIV) versus standard dose inactivated influenza vaccine(SDIV)among residents of long term care(LTC)settings.Non-inferiority will be determined by comparing baseline and one month post vaccination HAI and MN titers using non-inferiority analysis.|Day 0||||titers||95% Confidence Interval|Geometric Mean
2652246|NCT01654224|Secondary|Non-inferiority and Immunoprotection Persistence at 6 Months|Compare the immunogenicity via HAI and MN titers for HDIV and SDIV at 6 months in frail LTC residents|6 months|The above numbers reflect the participants with data available at 6 months. Eleven subjects (five in the high dose and 6 in the standard dose groups) died of non-related causes. Some of the samples were insufficient or unable to be collected.|||Titers||90% Confidence Interval|Geometric Mean
2652247|NCT01654224|Primary|Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings|The primary objective of this study is to determine the noninferiority of high- dose inactivated influenza vaccine (HDIV) versus standard dose inactivated influenza vaccine(SDIV)among residents of long term care(LTC)settings.Non-inferiority will be determined by comparing baseline and one month post vaccination HAI and MN titers using non-inferiority analysis.|30 days||||titers||95% Confidence Interval|Geometric Mean
2652248|NCT01654107|Primary|7-day Point Prevalence Abstinence|3-months after the Quit Date|3-months||||participants|||Number
2652249|NCT01654068|Secondary|Late Radiation Toxicity|The number of late side effects of radiation therapy will be documented (> 90 days after the start of radiation therapy)|2 years||||events (possible late side effects)|||Number
2652250|NCT01654068|Secondary|Acute Radiation Toxicity|The number of acute side effects of radiation therapy will be documented (≤ 90 days from start of radiation therapy)|90 days||||event (possible acute side effect)|||Number
2652251|NCT01654068|Primary|Time to Any Skeletal Related Event|Time to any skeletal related event most commonly symptomatic recurrence or progression with pain/neurologic impairment with evidence of radiographic progression (median local progression-free survival).|up to 24 months||||weeks||Full Range|Median
2652252|NCT01653964|Primary|Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI.||At time of study (within 2 days after exam) and when enrollment has been reached (approximately 24 months)|Of 82 patients recruited to the study (prior to breast biopsy), 34 had a histologically-proven diagnosis of breast cancer.|||cancers detected|||Number
2652253|NCT01653912|Secondary|PFS by RECIST of Subjects With Recurrent Platinum-resistant Ovarian Cancer (Phase 2-Cohort A)|PFS was defined as the number of months between date of first GSK2110183 treatment and the earliest date of disease progression by RECIST or death due to any cause whichever is earlier. Progression is defined using RECIST version 1.1 as at least a 20% increase in the sum of the longest diameter of target lesion in reference to the smallest sum of the longest diameter recorded since the treatment started.|From first dose until disease progression or death (approximately 36 months)|ATS population ((Phase 2-Cohort A)|||Months||95% Confidence Interval|Median
2652254|NCT01653912|Secondary|Progression Free Survival (PFS) by RECIST or Clinical Symptomatic Progression of Subjects With Recurrent Platinum-resistant Ovarian Cancer (Phase 2-Cohort A)|PFS was defined as the number of months between date of first GSK2110183 treatment and the earliest date of disease progression by RECIST or clinical symptomatic progression or death due to any cause whichever is earlier. Progression is defined using RECIST version 1.1 as at least a 20% increase in the sum of the longest diameter of target lesion in reference to the smallest sum of the longest diameter recorded since the treatment started.|From first dose until disease progression or death (approximately 36 months)|ATS population (Phase 2-Cohort A)|||Months||95% Confidence Interval|Median
2652331|NCT01653158|Secondary|Plasma Decay Half-Life (t1/2) of CP-751,871 in Cycle 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||hr||Standard Deviation|Mean
2652255|NCT01653912|Secondary|Phase 2: Response Rate (RR) Defined by Gynecologic Cancer Intergroup (GCIG) CA 125|RR is defined by the percentage of subjects with investigator-assessed Partial Cancer Antigen (CA) 125 Response (PR) or Complete CA 125 Response (CR) at any time during the study by GCIG CA 125. PR is greater than (>) 50% decrease in CA-125 values from baseline and no clinical or radiological evidence of new lesions. CR is decrease in the CA-125 to within the normal limits and less than (<) 40 IU/mL and no clinical or radiological evidence of disease.|From Month 1 to 6|ATS population (Phase 2)|||Percentage of participants|||Number
2652256|NCT01653912|Secondary|Phase 2 Safety: Number of Subjects Reporting Adverse Events|"Dose limiting toxicity (DLT): An event is considered a DLT if it had a reasonable causal relationship to study drug & occurs within first 3 weeks of therapy & met at least one of the following criteria:~Grade 3 or 4 non-hematologic toxicity as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.0, 2009 [NCI, 2009] with the exceptions of Grade 3 electrolyte disturbances that respond to correction within 24 hours; or Grade 3 rash, diarrhea, nausea, vomiting and mucositis that responded to standard medical supportive care within 48 hours).~Grade 4 neutropenia lasting ≥5 days~Febrile neutropenia~Grade 3 thrombocytopenia with bleeding~Grade 4 thrombocytopenia~Grade 4 anemia~Treatment delay of >14 days due to unresolved toxicity~Alanine aminotransferase (ALT) >3 times upper limit of normal (ULN) with bilirubin >2 times ULN"|Up to Day 51|ATS population (Phase 2)|||participants|||Number
2652257|NCT01653912|Secondary|Phase 2: Number of Subjects With Treatment-Emergent Adverse Events (TEAE) of Grade ≥3 in Severity||Up to Day 21 (Phase 2)|ATS population (Phase 2)|||participants|||Number
2652258|NCT01653912|Secondary|ORR in Phase 1 Subjects With Recurrent Platinum-resistant Ovarian Cancer|"Per RECIST version 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is disappearance of all target lesions and Partial Response (PR) is ≥30% decrease in the sum of the longest diameter of target lesions.~Overall Response (OR) = CR + PR."|Up to Week 3|ATS population (Phase 1)|||Percentage of participants|||Number
2652259|NCT01653912|Primary|ORR in Phase 2 Subjects With Recurrent Platinum-refractory Ovarian Cancer (Cohort B)|"Per RECIST version 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is Disappearance of all target lesions and Partial Response (PR) is ≥30% decrease in the sum of the longest diameter of target lesions.~Overall Response (OR) = CR + PR."|Every 3 weeks up to 6 months|As described in SAP (dated 14-Jul-2015), data was not analyzed separately for Cohort B (n=2) as there were <10 subjects in this group due to difficulty in enrolling Platinum-refractory ovarian cancer subjects.||||||
2652260|NCT01653912|Primary|Overall Response Rate (ORR) in Phase 2 Subjects With Recurrent Platinum-resistant Ovarian Cancer (Cohort A)|"Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.1 criteria for target lesions and assessed by MRI: Complete Response (CR) is Disappearance of all target lesions and Partial Response (PR) is greater than or equal to (≥) 30% decrease in the sum of the longest diameter of target lesions.~Overall Response (OR) = CR + PR."|Every 3 weeks up to 6 months|ATS population (Phase 2-Cohort A)|||Percentage of participants|||Number
2652261|NCT01653912|Primary|Phase 1: Maximum Tolerated Dose (MTD) of GSK2110183|MTD is defined as the highest dose at which 1 or fewer of up to 6 subjects experience a dose limiting toxicity (DLT) during the first 3 weeks of combination therapy. MTD was considered exceeded if 2 or more subjects in a cohort of up to 6 subjects experienced a DLT.|Up to Week 3|ATS population (Phase 1).|||mg|||Number
2652262|NCT01653912|Primary|Phase 1 Safety: Number of Subjects Reporting Adverse Events|"Study Treatment refers to GSK2110183 with or without Carboplatin and/or Paclitaxel.~Dose limiting toxicity (DLT): An event is considered a DLT if it had a reasonable causal relationship to study drug & occurs within first 3 weeks of therapy & met at least one of the following criteria:~Grade 3 or 4 non-hematologic toxicity as described in the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.0, 2009 [NCI, 2009] with the exceptions of Grade 3 electrolyte disturbances that respond to correction within 24 hours; or Grade 3 rash, diarrhea, nausea, vomiting and mucositis that responded to standard medical supportive care within 48 hours).~Grade 4 neutropenia lasting ≥5 days~Febrile neutropenia~Grade 3 thrombocytopenia with bleeding~Grade 4 thrombocytopenia~Grade 4 anemia~Treatment delay of >14 days due to unresolved toxicity~Alanine aminotransferase (ALT) >3 times upper limit of normal (ULN) with bilirubin >2 times ULN"|Up to Week 3|ATS population (Phase 1)|||participants|||Number
2652263|NCT01653912|Primary|Phase 1: Number of Subjects With Treatment-Emergent Adverse Events (TEAE) of Grade Greater Than or Equal to (≥) 3 in Severity||Up to Week 3|All Treated Subjects (ATS) in Phase 1.|||Participants|||Number
2652264|NCT01653782|Secondary|Cost Effectiveness|Assessments of direct and indirect cost. Further, assessments of performance is used to calculate production losses.|6 months, 12 months|||||||
2652265|NCT01653782|Primary|Number of Days on Sick Leave|Sick leave using self-reported data on number of days on sick leave|12 MONTHS|by a power calculation based on estimates of change in the primary outcome variables from earlier studies|||Days||Standard Deviation|Mean
2652266|NCT01653743|Secondary|Percentage of Participants With Clinical Pregnancy|Percentage of subjects with clinical pregnancy was assessed. Clinical pregnancy was defined as the presence of at least a fetal sac on TVUS.|Day 35 to 42 post hCG treatment|The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.|||percentage of subjects||95% Confidence Interval|Number
2652267|NCT01653743|Secondary|Percentage of Participants With Biochemical Pregnancy|Percentage of subjects with biochemical pregnancy was assessed. Biochemical pregnancy was defined as any miscarriage without any evidence of a fetal sac on TVUS on the Day 35 to 42 post hCG treatment, but with a positive serum β-hCG pregnancy test on Day 15 to 20 post hCG treatment (Beta-hCG level greater than [>] 10 IU/Liter)|Day 35 to 42 post hCG treatment|The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.|||percentage of subjects||95% Confidence Interval|Number
2652268|NCT01653743|Secondary|Mid-luteal Endometrial Thickness|Endometrial thickness was measured using TVUS.|Day 5 to 7 post hCG treatment|The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.|||millimeter||Standard Deviation|Mean
2652457|NCT01652573|Primary|Area Under the Curve for FGF23|FGF23 will be measured 0 to 24 hours post dose during a 24 hour admission and AUC calculated.|Time 0||||pg/ml*hr||95% Confidence Interval|Least Squares Mean
2652269|NCT01653743|Secondary|Percentage of Subjects With Ovulation Mid-Luteal Serum Progesterone (P4) Level of Greater Than or Equal (>=) 9.4 Nanogram Per Milliliter (ng/mL) or Clinical Pregnancy|Ovulation was defined as mid-luteal serum progesterone level of >= 9.4 ng/mL or clinical pregnancy. Clinical pregnancy was defined as the presence of at least a fetal sac on TVUS.|Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment|The Mod ITT population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.|||percentage of subjects||95% Confidence Interval|Number
2652270|NCT01653743|Primary|Percentage of Subjects With Ovulation Mid-luteal Serum Progesterone (P4) Level of Greater Than or Equal (>=) 5 Nanogram Per Milliliter (ng/mL) or Clinical Pregnancy|Ovulation was defined as mid-luteal serum progesterone level of >= 5 ng/mL or clinical pregnancy. Clinical pregnancy was defined as the presence of at least a fetal sac on transvaginal ultrasound (TVUS).|Mid-luteal phase progesterone assessed (Day 5 to 10) or clinical pregnancy (Day 35 to 42) post hCG treatment|The modified intent to treat (Mod ITT) population was defined as all subjects randomized to IMP (MSJ-0011 or u-hCG) and who completed the primary efficacy assessment.|||percentage of subjects||95% Confidence Interval|Number
2652271|NCT01653704|Primary|Total Ottawa GRS Score|The Ottawa GRS scale is a reliable and valid scale used to measure CRM performance in high fidelity simulation. The scale assesses five main CRM categories: leadership, problem solving, situational awareness, resource allocation and communication skills. In addition to these five categories, there is a category on overall performance of the participant. Each category is measured on a 7 point Likert scale with descriptive anchors to provide guidelines on alternating points along the scale. The categorical scores will be summed to give a total score of 6 to 42. Higher values represent a better outcome.|1 day||||units on a scale||Standard Deviation|Mean
2652272|NCT01653587|Other Pre-specified|Cardiovascular Death, Myocardial Infarction or Stroke||12 months||||Participants|||Count of Participants
2652273|NCT01653587|Secondary|Adverse Ischemic or Bleeding Events|Individual components of the primary objective, hematoma < 5 cm, cardiovascular death, myocardial infarction, stroke, major bleeding unrelated to puncture site or to coronary artery bypass grafting, device success and crossover rate between techniques|30 days||||Participants|||Count of Participants
2652274|NCT01653587|Primary|First Occurrence of Access Site Related Ischemic or Bleeding Complication|Vascular and systemic complications at arterial puncture site include major bleeding, retroperitoneal hemorrhage, compartment syndrome, hematoma ≥ 5 cm, pseudoaneurysm, arteriovenous fistula, infection, limb ischemia, asymptomatic arterial occlusion, adjacent nerve injury or need for vascular surgery repair.|30 days||||Participants|||Count of Participants
2652275|NCT01653509|Secondary|Participant Assessment of Symptom Intensity at Day 10|Cold sore symptoms (pain, burning, itching) assessment was performed on a 5-point scale: 1=Never Bothered 2=Rarely Bothered 3=Bothered Some of the Time 4=Bothered Often 5=Bothered All the Time.|Day 10|"ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement. There were differences in the number of participants analyzed for each end point, as represented by n."|||Units on a scale||Standard Deviation|Mean
2652276|NCT01653509|Secondary|Participant Assessment of Symptom Intensity at Day 5|Cold sore symptoms (pain, burning, itching) assessment was evaluated on a 5-point scale: 1=Never Bothered, 2=Rarely Bothered, 3=Bothered Some of the Time, 4=Bothered Often, 5=Bothered All the Time.|Day 5|"ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement. There were differences in number of participants analyzed for each end point as represented by n."|||Units on a scale||Standard Deviation|Mean
2652277|NCT01653509|Secondary|Participant Assessment of Patch Comfort and Noticeability at Day 10|"Participants reported experience of the patch aesthetics and cold sore noticeability on the cold sore using a 5-point scale ( 1=Strongly Disagree 2=Rather Disagree 3=Neither Agree nor Disagree 4=Mostly Agree 5=Completely Agree) on 9 questions asked to them:~Today my sore felt completely protected~Today my cold sores interfered with facial movements such as smiling, eating or drinking~Today my cold sores interfered with my interaction with other people~Today the patch disguised my cold sores~Today I was bothered by the appearance of my cold sores~Today my patch was easy to apply~Today the patch covering my cold sores was bothersome~Today the patches stayed in place on my cold sores until I removed them~Today the patches were easy to remove from my lip or skin"|Day 10|"ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement. There were differences in number of participants analyzed for each end point as represented by n."|||Units on a scale||Standard Deviation|Mean
2652278|NCT01653509|Secondary|Participant Assessment of Patch Comfort and Noticeability at Day 5|"Participants reported experience of the patch aesthetics and cold sore noticeability on the cold sore using a 5-point scale ( 1=Strongly Disagree 2=Rather Disagree 3=Neither Agree nor Disagree 4=Mostly Agree 5=Completely Agree) on 9 questions asked to them:~Today my sore felt completely protected~Today my cold sores interfered with facial movements such as smiling, eating or drinking~Today my cold sores interfered with my interaction with other people~Today the patch disguised my cold sores~Today I was bothered by the appearance of my cold sores~Today my patch was easy to apply~Today the patch covering my cold sores was bothersome~Today the patches stayed in place on my cold sores until I removed them~Today the patches were easy to remove from my lip or skin"|Day 5|"ITT population: all randomized participants who had a patch applied to their cold sore and had at least one post-baseline efficacy measurement. There were difference in number of participants analyzed for each end point as represented by n."|||Units on a scale||Standard Deviation|Mean
2652279|NCT01653509|Primary|Mean Change From Baseline in Color Intensity of Lesions|The redness of the cold sores to be measured and quantified using sophisticated, standardized and reproducible color photography. Parameter represents distance between test and control values according to a* axis and b* axis colour intensity values. The values on the scale ranged from -100 (green, lowest intensity) to +100 (red, highest intensity).|Baseline to Day 10|ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement.|||Units on a scale||Standard Error|Least Squares Mean
2652280|NCT01653509|Primary|Mean Change From Baseline in Temperature|Lesion thermographic parameters for TEV and MEV were analysed.|Baseline to Day 10|ITT population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement.|||Degree celsius||Standard Error|Least Squares Mean
2652281|NCT01653509|Primary|Mean Change From Baseline in Blood Flow|"Measurement of blood flow was performed using Field Laser Perfusion Imaging (FLPI) technique.~Total episode value (TEV) was calculated as the summation of (test region response minus control region response) across all days. Maximum episode value (MEV) was calculated as the maximum of (test region response minus control region response) across all days."|Baseline to Day 10|Intent to Treat (ITT) population: all randomized participants who had a patch applied to their cold sore and have at least one post-baseline efficacy measurement.|||Perfusion Units||Standard Error|Least Squares Mean
2652282|NCT01653418|Secondary|Time to Platelet Engraftment After V-BEAM.|Time to platelet engraftment is defined as the duration between Day 0 to the first day of platelet count sustained at > 20x109/L without transfusion. The median time to neutrophil and platelet engraftment will be reported.|Day +100|Two participants without evaluable responses due to early mortality were not included in this analysis.|||days||Full Range|Median
2652283|NCT01653418|Secondary|Treatment Related Mortality (TRM) of V-BEAM||Day +100||||participants|||Number
2652284|NCT01653418|Secondary|Number of Participants With Overall Survival (OS)|OS is defined as the duration from the time of transplant to death or last follow-up.|Median follow-up of 6 months (range: 6-12 months)||||participants|||Number
2652285|NCT01653418|Secondary|Time to Neutrophil Engraftment After V-BEAM.|Time to neutrophil engraftment is defined as duration between Day 0 to the first day of ANC > 0.5x109/L post transplant when it is sustained for more than three consecutive days.|Day +100|Two participants without evaluable responses due to early mortality were not included in this analysis.|||days||Full Range|Median
2652286|NCT01653418|Secondary|Toxicity of V-BEAM|"Graded per the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.~Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100.~This outcomes measures the common toxicities observed. Please refer to the Serious Adverse Event and Other Adverse Event sections of the results for further details."|30 days after end of treatment / Day +100||||participants|||Number
2652287|NCT01653418|Secondary|Very Good Partial Response Rate (VGPR+nCR+sCR+CR)|Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria.|Day +100|Two participants without evaluable responses due to early mortality were not included in this analysis.|||participants|||Number
2652288|NCT01653418|Secondary|Overall Response Rate (ORR)|"ORR includes Partial Response (PR) + Very Good Partial Response (VGPR) + Complete Response (CR)~Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria."|3 months following Day +100 visit|Two participants without evaluable responses due to early mortality were not included in this analysis.|||participants|||Number
2652289|NCT01653418|Secondary|Number of Participants With Progression-free Survival (PFS)|"PFS is defined as the duration from transplant to time of first progression, death, relapse after CR, or the date the patient was last known to be in remission.~Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria."|Median follow-up of 6 months (range: 6.0-12.0 months)|Two participants without evaluable responses due to early mortality were not included in this analysis.|||participants|||Number
2652290|NCT01653418|Primary|Complete Response Rate (Complete Response + Stringent Complete Response)|Defined by the International Myeloma Working Group (IMWG) criteria|Day +100|Two participants without evaluable responses due to early mortality were not included in this analysis.|||participants|||Number
2652291|NCT01653405|Secondary|Percentage of Patients With Mean INR Value Between 2.3 - 2.7|We compared the absolute percentage of patients with a mean INR of 2.3 - 2.7 before and after the intervention. We used a difference in differences analysis to compare the intervention and control groups.|Baseline and 4 years||||percentage change|||Number
2652292|NCT01653405|Secondary|Change in Percentage of Patients With Follow-up Within 7 Days After a Low INR Value (1.5 or Lower)|We compared the percentage of patients before and after the intervention. We used a difference in differences analysis to compare the intervention and control groups. Absolute percentage is reported.|Baseline and 4 years||||percentage change|||Number
2652293|NCT01653405|Secondary|Change in Percentage of Patients With Follow-up Within 7 Days After a High INR Value (>4.0)|We compared the percentage of patients with follow-up within 7 days before and after the intervention. We used a difference in differences analysis to compare the intervention and control groups.|Baseline and 4 years||||percentage change|||Number
2652294|NCT01653405|Secondary|Change in Gaps in Monitoring Per Patient-year Among Patients Receiving Anticoagulation With Warfarin|We compared the rate of 56-day gaps per patient year in the pre-intervention and post-intervention period. We used a difference in differences analysis to compare the intervention and control group. We are reporting absolute change.|Baseline and 4 years||||gaps per patient year||Standard Deviation|Mean
2652295|NCT01653405|Primary|Percent Change in Time in Therapeutic Range (TTR)|We compared TTR after the intervention to before the intervention. We used a difference in differences analysis to compare the absolute percentage change over time in the intervention group vs. the control group.|Baseline and 4 years|Patients receiving care at specified sites. Patient-level analyses were aggregated to the site level.|||percent change|||Number
2652296|NCT01653327|Secondary|Duration of Analgesic Effect|The secondary analysis is testing and estimating the analgesic effect of ketamine in comparison to placebo. Pain assessment will be analyzed using descriptive statistics. We will also determine average duration of analgesia. The effect of ketamine in comparison to placebo will be estimated with a mean and confidence interval.|After 9-10 doses, expected average 1 month|1-4 measurements of analgesic effects were obtained per participant. One assessment occurred per administered dose.|||minutes|Total visits where duration was measured|Standard Deviation|Mean
2652307|NCT01653262|Secondary|Incidence of Treatment Emergent Adverse Events During the Study Period|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A treatment emergent AE is any event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state.|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Safety Set (SS) consisted of all subjects who received at least 1 dose of Brivaracetam.|||events|||Number
2652297|NCT01653327|Primary|Change in Pain Score|The primary analysis is testing and estimating the effect of ketamine in comparison to placebo. Pain assessment will be analyzed using descriptive statistics. We will determine average pain scores. Pain will be measured using a 0-10 scale with 0 representing no pain; 1-3 representing mild pain; 4-6 representing moderate pain; and 7-10 representing severe pain. The effect of ketamine in comparison to placebo will be estimated with a mean and confidence interval. Proportional changes in pain scores (post-treatment pain score ÷ pre-treatment pain score) will be calculated and similarly analyzed. The proportion of subjects experiencing a reduction in pain scores of >33% will be calculated.|After 9-10 doses, expected average 1 month|1-4 pain measurements were obtained per participant. One assessment occurred per administered dose.|||score on a scale|Number of pain assessments|Standard Deviation|Mean
2652298|NCT01653288|Other Pre-specified|Preliminary Assessment of Efficacy of Later Use of the Intervention|"Child PTSD Symptom Scale (CPSS) measures child posttraumatic stress symptoms, possible range 0-51, high scores = more severe.~Pediatric Quality of Life Inventory (PedsQL) measures child health-related quality of life, possible range 0-100, high scores = better quality of life.~How I Coped Under Pressure Scale (HICUPS) measures child avoidance coping strategies, possible range 12-48, high scores = more use of avoidance coping.~Child Posttraumatic Cognitions Inventory (CPTCI) measures child post trauma cognitive appraisals, possible range 25-100, high scores = more maladaptive appraisals."|18 weeks|reporting on all participants who completed follow-up measures at 18 week. Note that at 12 weeks, those in the waitlist control group who completed the 12 week research assessment (N=28) were given access to the online intervention|||units on a scale||Standard Deviation|Mean
2652299|NCT01653288|Secondary|a Preliminary Assessment of the Efficacy of the Intervention|"Child PTSD Symptom Scale (CPSS) measures child posttraumatic stress symptoms, possible range 0-51, high scores = more severe.~Pediatric Quality of Life Inventory (PedsQL) measures child health-related quality of life, possible range 0-100, high scores = better quality of life.~How I Coped Under Pressure Scale (HICUPS) measures child avoidance coping strategies, possible range 12-48, high scores = more use of avoidance coping.~Child Posttraumatic Cognitions Inventory (CPTCI) measures child post trauma cognitive appraisals, possible range 25-100, high scores = more maladaptive appraisals."|12 weeks|descriptive statistics for all randomized participants who completed these measures at 12 week follow-up|||units on a scale||Standard Deviation|Mean
2652300|NCT01653288|Secondary|a Preliminary Assessment of the Efficacy of the Intervention|"Child PTSD Symptom Scale (CPSS) measures child posttraumatic stress symptoms, possible range 0-51, high scores = more severe.~Pediatric Quality of Life Inventory (PedsQL) measures child health-related quality of life, possible range 0-100, high scores = better quality of life.~How I Coped Under Pressure Scale (HICUPS) measures child avoidance coping strategies, possible range 12-48, high scores = more use of avoidance coping.~Child Posttraumatic Cognitions Inventory (CPTCI) measures child post trauma cognitive appraisals, possible range 25-100, high scores = more maladaptive appraisals."|6 weeks|descriptive statistics for all randomized participants who completed these measures at 6 week follow-up|||units on a scale||Standard Deviation|Mean
2652301|NCT01653288|Primary|Mean Time Spent Using the Intervention|Feasibility was measured using automated monitoring data. Mean time spent using the online intervention, across all sessions, in minutes is reported here.|6 weeks|Analyzing usage among all participants who received access (i.e. information on how to sign in) to the Coping Coach online intervention. 28 of 36 in the waitlist control condition completed a 12 week research assessment and then received sign-in information.|||minutes||Standard Deviation|Mean
2652302|NCT01653288|Primary|Feasibility of the Coping Coach Online Intervention|Feasibility was measured using automated monitoring data, the number of participants who logged in at least once and the number of participants who completed the entire online intervention are presented here.|6 weeks|Analyzing usage among all participants who received access (i.e. information on how to sign in) to the Coping Coach online intervention. 28 of 36 in the waitlist control condition completed a 12 week research assessment and then received sign-in information.|||Participants|||Count of Participants
2652303|NCT01653262|Secondary|Generalized Seizure Days Over the Treatment Period for Subjects With Idiopathic Generalized Epilepsy|"Generalized seizure days are standardized to a 28-day duration and changes in generalized seizure days are measured relative to the reported seizure counts for the 4 weeks prior to Visit 2 (Week 0).~Generalized seizures (Type II) include the following seizure types:~Absence (IIA1)~Atypical absence (IIA2)~Myoclonic (IIB)~Clonic (IIC)~Tonic (IID)~Tonic-clonic (IIE)~Atonic (IIF)~A specific effect of BRV on the occurrence of generalized seizures was not assessed."|From 4 weeks prior to Visit 2 (Week 0) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|This variable was not analyzed and no results are available.||||||
2652304|NCT01653262|Secondary|Partial Onset Seizure (POS) Frequency Over the Treatment Period for Subjects With Focal Epilepsy|"The POS frequency is standardized to a 28-day duration and changes in POS frequency are measured relative to the reported seizure counts for the 4 weeks prior to Visit 2 (Week 0).~Partial seizures can be classified into one of the following three groups:~Simple partial seizures (IA)~Complex partial seizures (IB)~Partial seizures evolving to secondarily generalized seizures (IC)"|From 4 weeks prior to Visit 2 (Week 0) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Efficacy Analysis Set (EAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline day of seizure daily record card (subject diary card).|||partial onset seizures||Inter-Quartile Range|Median
2652305|NCT01653262|Secondary|Occurrence of Serious Adverse Events During the Study Period|A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Safety Set (SS) consisted of all subjects who received at least 1 dose of Brivaracetam.|||events|||Number
2652306|NCT01653262|Secondary|Withdrawal Due to an Adverse Event (AE) During the Study Period|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Safety Set (SS) consisted of all subjects who received at least 1 dose of Brivaracetam.|||subjects|||Number
2652309|NCT01653262|Secondary|Number of Subjects Who Have a Complete Abatement of Nonpsychotic Behavioral Side Effects for the Last Assessment During the Treatment Period, Based on the Investigator's Overall Assessment|Nonpsychotic behavioral side effects include (but are not limited to) such symptoms as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, etc.|From Baseline (maximum of 12 weeks prior to Study Entry at Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.|||subjects|||Number
2652310|NCT01653262|Secondary|Change From Study Entry in Nonpsychotic Behavioral Side Effects to the End of the Treatment Period/Early Discontinuation Visit, Measured by Means of the Investigator Global Evaluation of Nonpsychotic Behavioral Side Effects (I-GEBSE) Scale|"There are seven levels for the I-GEBSE:~Marked improvement~Moderate improvement~Slight improvement~No change~Slight worsening~Moderate worsening~Marked worsening"|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.|||subjects|||Number
2652311|NCT01653262|Secondary|Shift in the Maximum Intensity From Baseline to the End of the Treatment Period for Side Effects Primarily Associated With Discontinuation of Levetiracetam (LEV) as Determined by the Investigator|Nonpsychotic behavioral side effects include (but are not limited to) such symptoms as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, etc.|From Baseline (maximum of 12 weeks prior to Study Entry at Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.|||subjects|||Number
2652312|NCT01653262|Primary|Percentage of Subjects Who Achieved a Clinically Meaningful Reduction of Nonpsychotic Behavioral Side Effects Based on the Investigator's Overall Assessment From Study Entry to the End of the Treatment Period|"Nonpsychotic behavioral side effects include (but are not limited to) such symptoms as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, etc.~The Investigator completed the assessment by answering the following:~Has there been a clinically meaningful reduction of nonpsychotic behavioral side effects since the start of BRV?~- Yes/No"|From Study Entry (Visit1, Week -1) to the end of the Treatment Period (Visit 6, Week 12) or Early Discontinuation Visit|The Full Analysis Set (FAS) consisted of all subjects who received at least 1 dose of Brivaracetam and had at least 1 post-Baseline evaluation of behavioral side effects.|||percentage of subjects|||Number
2652313|NCT01653210|Secondary|Glycemic Changes During Luteal Phase|Changes in estrogen and progesterone will be primary drivers of hyperglycemia risk during the luteal phase. These data will be analyzed as continuous variables.|Three Menstrual Cycles||||pg/mL||Standard Error|Mean
2652314|NCT01653210|Primary|High Blood Glucose Index (HBGI)|"Measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events.~HBGI < 4.5 is associated with lower risk of hyperglycemia, 4.5 < HBGI < 9 is associated with a moderate risk of hyperglycemia and HBGI > 9 is associated with high risk of hyperglycemia.~Our primary outcome measure is hyperglycemia risk during the luteal phase of the menstrual cycle. The primary hypothesis is there is an increased hyperglycemia risk during the luteal phase when compared to the follicular phase. Subjects will be compared to themselves across the three menstrual cycles captured. Hyperglycemia will be primarily assessed by high blood glucose index which was assessed over 3 menstrual cycles at specific time points in the cycle."|Three menstrual cycles (average length of one cycle was 28.7 days)||||index score||Standard Error|Mean
2652315|NCT01653158|Secondary|Time of Last Quantifiable Time Point (Tlast) of CP-751,871 in Cycle 1 and Cycle 4|Blood samples were collected at timepoints prespecified in the study protocol. Tlast of CP-751,871 was the last time point when blood sample collected was quantifiable for CP-751,871.|Cycle 1 and 4: prior to CP-751,871 infusion, at 1 hour post CP-751,871 infusion, and at 1, 3, 7 days post end of docetaxel infusion|This OM was not reported due to registration error. This parameter was not planned or analyzed for this study.||||||
2652316|NCT01653158|Secondary|Observed Concentration of CP-751,871 at Day 22 (Cday22) of Cycle 1 and 4|Cday22 is the measured CP-751,871 plasma concentration in blood sample collected at Day 22.|Cycle 1: 30 minutes prior to the Cycle 2 CP-751,871 infusion (this is Day 22 for Cycle 1); Cycle 4: 30 minutes prior to the Cycle 5 CP-751,871 infusion (this is Day 22 for Cycle 4)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort.|||mg/L||Standard Deviation|Mean
2652317|NCT01653158|Other Pre-specified|Dose Normalized Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)(dn)) of CP-751,871 in Cycle 4|Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) divided by total dose|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error. This parameter was not planned or analyzed for this study.||||||
2652318|NCT01653158|Other Pre-specified|Dose Normalized Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)(dn)) of CP-751,871 in Cycle 1|Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) divided by total dose|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error. This parameter was not planned or analyzed for this study.||||||
2652319|NCT01653158|Secondary|Observed Accumulation Ratio (Rac) of CP-751,871|AUCtao of Cycle 4 divided by AUC(0-d22) of Cycle 1|30 minutes prior to CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of CP-751,871 infusion; and 30 minutes prior to the next cycle CP-751,871 infusion (Day 22) in Cycle 1 and Cycle 4|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||Ratio||Standard Deviation|Mean
2652458|NCT01652534|Secondary|Number of Participants With Drug Safety Reports|Analyzing the safety of the medication, Amantadine. Data regarding the medication will be collected from the patient on each visit including any adverse events since the last visit, frequency and severity of falls. This is done in order to determine the safety of Amantadine.|Week 4||||Participants|||Count of Participants
2652320|NCT01653158|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of CP-751,871 in Cycle 4|Area under the plasma concentration versus time curve (AUC) from time zero to tau, the dosing interval, where tao is the actual time of the predose sample for the next cycle.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mg*hr/L||Standard Deviation|Mean
2652321|NCT01653158|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of CP-751,871 in Cycle 1|Area under the plasma concentration versus time curve (AUC) from time zero to tau, the dosing interval, where tao is the actual time of the predose sample for the next cycle.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|This OM was not reported because it is the same as Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) in Cycle 1 (OM 23), for both represented the planned 21-day dosing interval.||||||
2652322|NCT01653158|Secondary|Volume of Distribution (Vz) of CP-751,871 in Cycle 4|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to insufficient data: the parameter was estimable in only 3 of 25 subjects.||||||
2652323|NCT01653158|Secondary|Apparent Volume of Distribution (Vz/F) of CP-751,871 in Cycle 4|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error: apparent volume of distribution (Vz/F) is for oral dose. Volume of Distribution (Vz) of CP-751,871 after intravenous dosing in Cycle 4 (OM 38) was the correct outcome measure to be registered.||||||
2652324|NCT01653158|Secondary|Volume of Distribution (Vz) of CP-751,871 in Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mL/kg||Standard Deviation|Mean
2652325|NCT01653158|Secondary|Apparent Volume of Distribution (Vz/F) of CP-751,871 in Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error: apparent volume of distribution (Vz/F) is for oral dose. Volume of Distribution (Vz) of CP-751,871 after intravenous dosing in Cycle 1 (OM 36) was the correct outcome measure to be registered.||||||
2652326|NCT01653158|Secondary|Volume of Distribution at Steady State (Vss) of CP-751,871 in Cycle 4|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to insufficient data: the parameter was estimable in only 3 of 25 subjects.||||||
2652327|NCT01653158|Secondary|Volume of Distribution at Steady State (Vss) of CP-751,871 in Cycle 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mL/kg||Standard Deviation|Mean
2652328|NCT01653158|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-751,871 in Cycle 4||30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||hr||Standard Deviation|Mean
2652329|NCT01653158|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of CP-751,871 in Cycle 1||30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||hr||Standard Deviation|Mean
2652330|NCT01653158|Secondary|Plasma Decay Half-Life (t1/2) of CP-751,871 in Cycle 4|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to insufficient data: the parameter was estimable in only 3 of 25 subjects.||||||
2659948|NCT01585441|Secondary|Change in Serum Dihydrotestosterone (DHT) Concentration at the Safety Visit Compared to Baseline|The mean change is reported in picograms of DHT per milliliter of serum.|Final Study Visit||||pg/mL||Standard Deviation|Mean
2652332|NCT01653158|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-751,871 in Cycle 4|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mg*hr/L||Standard Deviation|Mean
2652333|NCT01653158|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of CP-751,871 in Cycle 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mg*hr/L||Standard Deviation|Mean
2652334|NCT01653158|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of CP-751,871 in Cycle 4|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported due to registration error. AUCinf is not scientifically appropriate for repeated dosing (Cycle 4).||||||
2652335|NCT01653158|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of CP-751,871 in Cycle 1|Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mg*hr/L||Standard Deviation|Mean
2652336|NCT01653158|Secondary|Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) of CP-751,871 in Cycle 4|Area under the plasma concentration versus time curve (AUC) from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|This OM was not reported since the actual dosing interval (tau) was longer than 3 weeks in some patients and AUC(0-d22) may not accurately represent multiple-dose exposure for these patients. Therefore only AUCtau, which represents exposure for the actual Cycle 4 interval, was reported for Cycle 4 (OM 40).||||||
2652337|NCT01653158|Secondary|Area Under the Curve From Time Zero (Day 1) to Day 22 (AUC(0-d22)) of CP-751,871 in Cycle 1|Area under the plasma concentration versus time curve (AUC) from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mg*hr/L||Standard Deviation|Mean
2652338|NCT01653158|Secondary|Maximum Observed Plasma Concentration (Cmax) of CP-751,871 in Cycle 4||30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mg/L||Standard Deviation|Mean
2652339|NCT01653158|Secondary|Maximum Observed Plasma Concentration (Cmax) of CP-751,871 in Cycle 1||30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mg/L||Standard Deviation|Mean
2652340|NCT01653158|Secondary|Systemic Clearance (CL) of CP-751,871 in Cycle 4|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|30 minutes prior to the Cycle 4 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 4 CP-751,871 infusion; and 30 minutes prior to the Cycle 5 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mL/day/kg||Standard Deviation|Mean
2652341|NCT01653158|Secondary|Systemic Clearance (CL) of CP-751,871 in Cycle 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|30 minutes prior to the Cycle 1 CP-751,871 infusion; 1 hour, and 1 (Day 2), 3 (Day 4) and 7 (Day 8) days post end of the Cycle 1 CP-751,871 infusion; and 30 minutes prior to the Cycle 2 CP-751,871 infusion (Day 22)|All participants who started treatment and had evaluable PK data, excluding those who were enrolled in the PK drug interaction expansion cohort|||mL/day/kg||Standard Deviation|Mean
2652342|NCT01653158|Secondary|Circulating Tumor Cells (CTCs), CTCs Expressing Insulin-like Growth Factor 1 Receptor (IGF-1R), and Circulating Endothelial Cells (CECs)||Predose on Day 1 and on Day 8 of each cycle, and End of Study (28 days after the last CP-751,871 infusion)|The data of CTCs and CTCs expressing IGF-IR were limited. Analyses of these biomarkers in the aggregate population were not feasible due to insufficient numbers. The data of CECs were not analyzed due to insufficient levels for quantification.||||||
2652343|NCT01653158|Secondary|Time to Tumor Progression (TTP)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD])|Baseline, every 2 months (approximately 7-10 days prior to the start of the next dose) up to Cycle 17 (1 cycle = 21 days)|This outcome measure (OM) was not analyzed due to incomplete progression reporting, which could not permit accurate estimate of time to tumor progression (TTP).||||||
2652344|NCT01653158|Secondary|Number of Participants With Objective Response (OR)|Number of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.|Baseline, every 2 months (approximately 7-10 days prior to the start of the next dose) up to Cycle 17 (1 cycle = 21 days)|This outcome measure was not reported because data was available in individual participant listing only and not statistically summarized for the analysis.||||||
2652345|NCT01653158|Secondary|Number of Participants With the Occurrence of Human Anti-human Antibody (HAHA) Response to CP-751,871|The development of HAHA is considered clinically relevant when temporally associated to the onset of adverse events or a significant decrease in the plasma concentrations of CP-751,871. The positive value is defined as ≥3.32.|30 minutes predose at each cycle, End of Study (28 days after the last CP-751,871 infusion), and 150 days after the last CP-751,871 infusion|All enrolled participants who started treatment and had evaluable HAHA data|||Participants|||Number
2652346|NCT01653158|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Docetaxel in Cycle 4||30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||hr||Standard Deviation|Mean
2652347|NCT01653158|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Docetaxel in Cycle 1||30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||hr||Standard Deviation|Mean
2652348|NCT01653158|Primary|Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) of Docetaxel in Cycle 4|Maximum Observed Plasma Concentration (Cmax) divided by dose|30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||ng/mL/(mg/m^2)||Standard Deviation|Mean
2652349|NCT01653158|Primary|Dose Normalized Maximum Observed Plasma Concentration (Cmax(dn)) of Docetaxel in Cycle 1|Maximum Observed Plasma Concentration (Cmax) divided by dose|30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||ng/mL/(mg/m^2)||Standard Deviation|Mean
2652350|NCT01653158|Primary|Maximum Observed Plasma Concentration (Cmax) of Docetaxel in Cycle 4||30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||ng/mL||Standard Deviation|Mean
2652351|NCT01653158|Primary|Maximum Observed Plasma Concentration (Cmax) of Docetaxel in Cycle 1||30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||ng/mL||Standard Deviation|Mean
2652352|NCT01653158|Primary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) of Docetaxel in Cycle 4|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by dose|30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||ng•hr/mL/(mg/m^2)||Standard Deviation|Mean
2652353|NCT01653158|Primary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast(dn)) of Docetaxel in Cycle 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by dose|30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||ng•hr/mL/(mg/m^2)||Standard Deviation|Mean
2652354|NCT01653158|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Docetaxel in Cycle 4|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||ng*hr/mL||Standard Deviation|Mean
2652355|NCT01653158|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Docetaxel in Cycle 1|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||ng*hr/mL||Standard Deviation|Mean
2652391|NCT01652885|Primary|Number of Participants With Clinically Significant Vital Signs Abnormalities|Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion.|Baseline (Day 1) up to Day 29|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
2652356|NCT01653158|Primary|Area Under the Curve From Time Zero to 25 Hours Postdose (AUC25) of Docetaxel in Cycle 4|Area under the plasma concentration versus time curve (AUC) from time zero to 25 hours post dose, the nominal time of the last sample (24 hours after end of infusion)|30 minutes before CP-751,871 infusion; 1 hour after the end of CP-751,871 infusion; 30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||ng*hr/mL||Standard Deviation|Mean
2652357|NCT01653158|Primary|Area Under the Curve From Time Zero to 25 Hours Postdose (AUC25) of Docetaxel in Cycle 1|Area under the plasma concentration versus time curve (AUC) from time zero to 25 hours post dose, the nominal time of the last sample (24 hours after end of infusion)|30 minutes before docetaxel infusion; 30 and 50 minutes after the start of docetaxel infusion; and 30 minutes and 1, 3, 8, and 24 hours after the end of docetaxel infusion|Participants who were enrolled into the PK drug interaction expansion cohort, started treatment and had evaluable PK data.|||nanogram*hour/millilitre (ng*hr/mL)||Standard Deviation|Mean
2652358|NCT01653158|Primary|Recommended Phase 2 Dose (RP2D)||Cycle 1 Day 1 through Cycle 1 Day 21|Safety analysis set: all enrolled participants who started treatment.|||mg/kg|||Number
2652359|NCT01653158|Primary|Maximum Tolerated Dose (MTD)||Cycle 1 Day 1 through Cycle 1 Day 21|Safety analysis set: all enrolled participants who started treatment, but excluding those who were enrolled in the expansion cohort.|||mg/kg|||Number
2652360|NCT01653132|Secondary|Number of Participants With Response, Defined as Subjects With ≥ 20% Reduction in Saliva Volume.|measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period|between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period||||participants|||Number
2652361|NCT01653132|Secondary|Number of Participants With Response, Defined as Subjects With ≥ 2 Point Improvement in the DFSS Scores.|measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.|baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period||||participants|||Number
2652362|NCT01653132|Secondary|Change in Drooling Frequency and Severity Scale (DFSS) Scores|"measured between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.Drooling Frequency and Severity Score. The Drooling Score equals the sum of the Severity and Frequency sub-scores. The range is 2-9, higher numbers represent worse drooling Drooling Severity Scale~= Never drools, dry~= Mild-drooling, only lips wet~= Moderate- drool reaches the lips and chin~= Severe- drool drips off chin & onto clothing~= Profuse- drooling off the body and onto objects (furniture, books) Drooling Frequency Scale~1. = No drooling 2. = Occasionally drools 3. = Frequently drools 4. = Constant drooling"|baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period||||units on a scale||Standard Deviation|Mean
2652363|NCT01653132|Primary|Objectively Measured Percentage Salivary Weight|Percentage change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.|baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period||||percentage change from baseline||Standard Deviation|Mean
2652364|NCT01653132|Primary|Objectively Measured Salivary Weight|Change in saliva weight between baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period.|baseline and one month post-injection in the Incobotulinum toxin A period compared to the placebo period||||gm||Standard Deviation|Mean
2652365|NCT01653028|Secondary|Adverse Events|Adverse Events: Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events were collected every cycle during treatment and up to one month after treatment. Adverse events were summarized using summary statistics and frequency tables for each separate cohort. Per protocol, analysis was descriptive in nature. In this section, the number of patients that reported a grade 4 or higher event are summarized. A complete listing of Adverse Events is provided in the Adverse Events section below.|During treatment and up to 5 years|All patients that began study treatment were assessed for this endpoint.|||participants|||Number
2652366|NCT01653028|Secondary|Progression Free Survival (PFS)|The distribution will be estimated by the methods of Kaplan and Meier. The estimates of PFS at specific time points will be calculated (eg, median, 1 year PFS).|The time between registration to disease progression or death, assessed up to 18 months||||Weeks||95% Confidence Interval|Median
2652367|NCT01653028|Secondary|Overall Survival (OS)|The distribution will be estimated by the methods of Kaplan and Meier. The estimates of survival at specific time points will be calculated (eg, median, 6 month survival).|The time between registration and death, assessed up to 18 months||||Weeks||95% Confidence Interval|Median
2652368|NCT01653028|Primary|The Primary Endpoint for This Trial Was the Percent of Confirmed Tumor Responses. Confirmed Tumor Response to Treatment Was Defined as a Complete or Partial Response(Per RECIST 1.1) on Two Consecutive Evaluations at Least 6 Weeks Apart.|The primary endpoint was estimated by the number of confirmed responses divided by the total number of evaluable patients per cohort. The study used a two stage Simon design to assess the primary endpoint. A confirmed tumor response rate of 5% was considered not promising; an observed confirmed response rate of 25% was considered promising. One confirmed response within the initial 9 patients enrolled within each cohort, expanded enrollment to 24 patients in that cohort. 3 out of 24 patients with confirmed tumor responses was considered evidence that this treatment could be recommended for further testing. This study design yielded 90% power to detect a true confirmed response rate of at least 25% at .10 level of significance if the true rate is at most 5%. There was a 63% chance of stopping early if the true confirmed response rate was 5%.|Up to 18 months||||percentage of patients with response|||Number
2652402|NCT01652872|Secondary|Geometric Mean Cumulative Dose of Darbepoetin Alfa Per 4 Weeks|Cumulative doses of darbepoetin alfa adjusted for investigation product exposure time (e.g. mean cumulative darbepoetin alfa dose per 4 weeks) were calculated for each treatment group using the total cumulative dose during the study divided by total number of weeks dosed then multiplied by 4. The geometric mean cumulative dose is presented.|From randomization until the end of study, up to week 101.|The full analysis set included all randomized participants who received at least 1 dose of investigational product.|||mcg||Standard Error|Geometric Mean
2652369|NCT01652976|Secondary|Quality of Life, as Measured by the Functional Assessment of Chronic Illness Therapy; Hepatobiliary Cancer (FACT-Hep) Questionnaire (Version 4.0)|The FACT-Hep consists of 45 questions where subjects respond with a score on a scale of 0 (worst)-4 (best). The responses to the questions are summed to calculate 5 subscores: Physical Well-Being (PWB), Social Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and Hepatobiliary Cancer Subscale (HCS). The mean difference in each of the 5 subscores from baseline, as well as the total score of the 5 subscores (the FACT-Hep Total Score) for the entire study population is reported here. The mean difference in the FACT-G Total Score (calculated by summing the PWB, SWB, EWB, and FWB subscores) is also reported here. A negative mean difference indicates a decrease from baseline in QOL. Score ranges- PWB subscore: 0-28, SWB subscore: 0-28, EWB subscore: 0-24, FWB subscore: 0-28, HCS subscore: 0-72, FACT-G Total Score: 0-108, and FACT-Hep Total Score: 0-180. A higher value for each subscore or total score indicates better QOL.|3 years||||score on a scale||95% Confidence Interval|Mean
2652370|NCT01652976|Secondary|Quality of Life, as Measured by the Cancer Therapy Satisfaction Questionnaire (CTSQ), 2007|To determine the quality of life (QOL) of patients receiving this therapy using the CTSQ questionnaire. The CTSQ consists of 16 questions where subjects respond with a score on a scale of 0 (worst)-4 (best). The responses to the questions are used to calculate 3 subscores: Expectations of Therapy (ET), Feelings about Side Effects (FSE), and Satisfaction with Therapy (SWT). Each subscore is calculated by multiplying the mean response value for the questions used to calculate that subscore by 25. The maximum value is 100 and the minimum value is 0 for all 3 subscores. A higher subscore indicates better QOL in that area. The mean difference in each of the 3 subscores from baseline and 95% confidence interval for the entire study population is reported here. A negative mean difference indicates a decrease from baseline in QOL for that area.|3 years||||score on a scale||95% Confidence Interval|Mean
2652371|NCT01652976|Secondary|Drug Compliance|To determine patient compliance with oral therapy. For this outcome measure, compliance with oral therapy is defined as the percentage of subjects that took dasatinib for at least one cycle. Compliance with oral therapy was documented with a medication diary that subjects were asked to complete to document whether each dose of dasatinib was taken.|3 years||||percentage of subjects||95% Confidence Interval|Number
2652372|NCT01652976|Secondary|Safety and Tolerability|To determine the safety profile and tolerability of this regimen in this population by evaluating acute treatment related toxicities using CTCAE v4.0 criteria. Using the CTCAE v4.0, the severity of each adverse event reported was graded on a scale of 1 (mild severity) to 5 (fatal). For this outcome measure the percentage of subjects experiencing any adverse event of each CTCAE grade was tabulated.|3 years||||percentage of subjects|||Number
2652373|NCT01652976|Secondary|Site of Failure|To determine the site of failure of this regimen in this population. The site of failure is the anatomical site(s) where disease progression by RECIST 1.1 criteria was noted on imaging.|3 years||||Participants|||Count of Participants
2652374|NCT01652976|Secondary|Clinical Benefit Rate|To determine the clinical benefit rate (CBR). The CBR is defined as the percentage of subjects who achieved either a complete or partial response or stable disease by RECIST 1.1 criteria. RECIST 1.1 criteria defines a partial response as a decrease of the sum of the largest diameter each target lesion by at least 30%. A complete response is defined as the disappearance of all target lesions (except lymph nodes, whose short axis must measure 10 mm or less). By RECIST 1.1 criteria, a subject is considered to have stable disease when the sum of the largest diameter of the target lesions has neither decreased enough to qualify as a partial response not increased enough to qualify as progressive disease.|3 years||||percentage of subjects||95% Confidence Interval|Number
2652375|NCT01652976|Secondary|Median Overall Survival|To determine median overall survival (OS) in months|4 years||||months||95% Confidence Interval|Median
2652376|NCT01652976|Secondary|Median Time To Progression|To determine the median time to progression (TTP). TTP is defined as the time (in months) from when a subject achieves either a complete or partial response by RECIST 1.1 criteria until progressive disease (by RECIST 1.1 criteria) or death occurs.|3 years|The number of participants analyzed for this outcome measure includes only the 11 participants who achieved either a complete or partial response by RECIST 1.1 criteria during study participation.|||months||90% Confidence Interval|Median
2652377|NCT01652976|Secondary|Freedom From Metastasis|To determine the rate of freedom from metastasis (FFM), which is defined as the percentage of subjects with documented progressive disease (by RECIST 1.1 criteria) who had no new lesions. RECIST 1.1 criteria defines progressive disease as the appearance of one or more new lesions and/or the increase of the sum of the largest diameter of the target lesions by at least 20% from the smallest sum collected (the sum must also have increased by at least 5 mm).|3 years|The number of participants analyzed for this outcome measure only includes the 29 participants who had documented disease progression (by RECIST 1.1 criteria) during study participation.|||percentage of subjects||95% Confidence Interval|Number
2652378|NCT01652976|Secondary|Response Rate|To determine the response rate (RR) by RECIST 1.1 criteria. The response rate is the number of subjects who had either a complete or partial response by RECIST 1.1 criteria. RECIST 1.1 criteria defines a partial response as a decrease of the sum of the largest diameter each target lesion by at least 30%. A complete response is defined as the disappearance of all target lesions (except lymph nodes, whose short axis must measure 10 mm or less). The imaging modality used for all RECIST assessments in this study was CT.|3 years||||percentage of subjects||95% Confidence Interval|Number
2652379|NCT01652976|Primary|Progression Free Survival (PFS)|Determine activity of 5-Fluorouracil, leucovorin, and oxaliplatin (FOLFOX) plus dasatinib on progression free survival (PFS) in patients with metastatic pancreatic adenocarcinoma|3 years||||months||95% Confidence Interval|Median
2652380|NCT01652885|Secondary|Change From Baseline in Signs and Symptoms of Atopic Dermatitis at Day 8, 15, 22 and 29|5 signs and symptoms of atopic dermatitis were: 1) erythema, 2) pruritus, 3) exudation, 4) excoriation and 5) lichenification. The severity of each of these 5 signs and symptoms were assessed on a 4 point scale, ranging from 0 (none) to 3 (severe). Higher scores (for each of the 5 signs and symptoms) indicate higher degree of severity of atopic dermatitis.|Baseline, Day 8, 15, 22, 29|Safety population included all participants who were enrolled and had received any amount of the study drug.|||units on a scale||Standard Deviation|Mean
2652417|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in Apolipoprotein B/Apolipoprotein A-1 Ratio||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2652381|NCT01652885|Secondary|Number of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA)|ISGA assess severity of atopic dermatitis on a 5 point scale ranged from 0 (clear) to 4 (maximum severe), where higher scores indicate higher degree of atopic dermatitis. Grades for classification of severity: 0= clear (minor residual discoloration, no erythema or induration or papulation, no oozing or crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration or papulation and no oozing or crusting), 2= mild (faint pink erythema with mild induration or papulation and no oozing or crusting), 3= moderate (pink-red erythema with moderate induration or papulation with or without oozing or crusting) and 4= severe (deep or bright red erythema with severe induration or papulation and with oozing or crusting). Treatment success was defined as ISGA score of 0 or 1, and a minimum improvement of 2 grades in ISGA from Baseline to Day 29.|Baseline up to Day 29|Safety population included all participants who were enrolled and had received any amount of the study drug.|||Participants|||Count of Participants
2652382|NCT01652885|Primary|Apparent Terminal Half-Life of AN2728 and Major Oxidative Metabolites of AN2728: Day 8|Apparent terminal half-life, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure. Apparent terminal half-life is the time measured for the drug concentration to decrease by one-half in plasma.|Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8|PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, “n” signifies number of participants who were evaluable for specific categories.|||hour||Standard Deviation|Mean
2652383|NCT01652885|Primary|Area Under the Concentration-Time Curve From Hour Zero To the 12 Hour Post-Dose Measurable Concentration of AN2728 and Major Oxidative Metabolites of AN2728: Day 8|Area under the concentration-time curve from hour zero to the 12 hour post-dose measurable concentration, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure.|Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12 hours post-dose on Day 8|PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, 'N' signifies evaluable participants for this outcome measure.|||nanogram*hour per milliliter||Standard Deviation|Mean
2652384|NCT01652885|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 8|Time to reach maximum plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure.|Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8|PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, 'N' signifies evaluable participants for this outcome measure.|||hour||Full Range|Median
2652385|NCT01652885|Primary|Maximum Observed Plasma Concentration (Cmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 8|Maximum observed plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 8 was reported in the outcome measure.|Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 8|"PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, Number of Participants Analyzed (N) signifies evaluable participants for this outcome measure."|||nanogram per milliliter||Standard Deviation|Mean
2652386|NCT01652885|Primary|Apparent Terminal Half-Life of AN2728 and Major Oxidative Metabolites of AN2728: Day 1|Apparent terminal half-life, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure. Apparent terminal half-life is the time measured for the drug concentration to decrease by one-half in plasma.|Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1|PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations. Here, “n” signifies number of participants who were evaluable for specific categories.|||hour||Standard Deviation|Mean
2652387|NCT01652885|Primary|Area Under the Concentration-Time Curve From Hour Zero To the 12 Hour Post-Dose Measurable Concentration of AN2728 and Major Oxidative Metabolites of AN2728: Day 1|Area under the concentration-time curve from hour zero to the 12 hour post-dose measurable concentration, of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure.|Pre-dose (0 hour), 1, 2, 4, 6, 8 and 12 hours post-dose on Day 1|PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations.|||nanogram*hour per milliliter||Standard Deviation|Mean
2652388|NCT01652885|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 1|Time to reach maximum plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure.|Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1|PK population included participants from the safety population who had completed any portion of the PK day procedures and evaluations.|||hour||Full Range|Median
2652389|NCT01652885|Primary|Maximum Observed Plasma Concentration (Cmax) of AN2728 and Major Oxidative Metabolites of AN2728: Day 1|Maximum observed plasma concentration of AN2728 and its two identified oxidative metabolites, AN7602 and AN8323 on Day 1 was reported in the outcome measure.|Pre-dose (0 hour), 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 1|Pharmacokinetic (PK) population included participants from the safety population who had completed any portion of the PK day procedures and evaluations.|||nanogram per milliliter||Standard Deviation|Mean
2652390|NCT01652885|Primary|Number of Participants With Clinically Significant Laboratory Test Abnormalities|Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). Clinical significance of laboratory parameters was determined at the investigator's discretion.|Baseline (Day 1) up to Day 29|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
2652418|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in Total Cholesterol/HDL-C Ratio||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2652419|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in VLDL-C||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2652392|NCT01652885|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death;initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Day 29 that were absent before treatment or that worsened relative to pretreatment state.|Baseline (Day 1) up to Day 29|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
2652393|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 29|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 29 were reported in this outcome measure.|Day 29|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
2652394|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 22|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 22 were reported in this outcome measure.|Day 22|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
2652395|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 15|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 15 were reported in this outcome measure.|Day 15|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
2652396|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 9|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 9 were reported in this outcome measure.|Day 9|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
2652397|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 8|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 8 were reported in this outcome measure.|Day 8|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
2652398|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 6|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 6 were reported in this outcome measure.|Day 6|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
2652399|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 4|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 4 were reported in this outcome measure.|Day 4|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
2652400|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Day 2|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Day 2 were reported in this outcome measure.|Day 2|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
2652401|NCT01652885|Primary|Number of Participants With Local Tolerability Symptoms According to Severity on Baseline|Local tolerability symptoms, burning or stinging, were classified according to severity as: 1) none = no stinging or burning, 2) mild = slight warm, tingling sensation; not really troublesome, 3) moderate = definite warm; tingling or stinging sensation; troublesome and 4) severe = hot, tingling or stinging sensation that caused definite discomfort. Number of participants with local tolerability symptoms according to severity on Baseline were reported in this outcome measure.|Baseline|Safety population included all participants who were enrolled and had received any amount of the study drug.|||participants|||Number
2652420|NCT01652703|Secondary|Percent Change From Baseline to Week 12 in Apolipoprotein B||Baseline and Week 12|Full analysis set; missing data were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2652403|NCT01652872|Secondary|Mean Achieved Hb Concentration While Receiving Investigational Product|Average achieved Hb concentration while receiving investigational product was recorded as mean Hb using the area under the curve (AUC) method for each treatment group. The AUC of Hb was calculated according to the trapezoidal method, standardized as daily AUC. Participants with available Hb values from study day 85 (week 13) to the last dose date were included in the calculation.|From week 13 until the end of study, up to week 101.|The full analysis set included all randomized participants who received at least 1 dose of investigational product.|||g/dL||Standard Error|Mean
2652404|NCT01652872|Secondary|Time to First RBC Transfusion|Time to first RBC transfusion during the evaluation period was recorded for each treatment group. The evaluation period began from the date of randomization, and participants were censored at the last dose of investigational product plus 3 months or end of study, whichever was earlier (on-treatment approach). The time to first RBC transfusion is presented using Kaplan-Meier (KM) estimates at 6, 12, 18, and 24 months.|From randomization until the end of study, up to week 101.|The full analysis set included all randomized participants who received at least 1 dose of investigational product.|||Months|||Number
2652405|NCT01652872|Secondary|Mean Number of Units of RBC Transfused|The total number of units of RBC transfused per participant during the evaluation period was recorded for each treatment group. The evaluation period began from the date of randomization, and participants were censored at the last dose of investigational product plus 3 months or end of study, whichever was earlier (on-treatment approach). The mean total number of RBC units transfused per participant is presented.|From randomization until the end of study, up to week 101.|The full analysis set included all randomized participants who received at least 1 dose of investigational product.|||Units of transfused RBC||95% Confidence Interval|Mean
2652406|NCT01652872|Primary|Percentage of Participants in Receipt of 1 or More RBC Transfusions|The percentage of participants receiving at least 1 RBC transfusion during the evaluation period was recorded for each treatment group. The evaluation period began from the date of randomization, and participants were censored at the last dose of investigational product plus 3 months or end of study, whichever was earlier (on-treatment approach).|From randomization until the end of study, up to week 101.|The full analysis set included all randomized participants who received at least 1 dose of investigational product.|||Percentage of Participants||95% Confidence Interval|Number
2652407|NCT01652729|Secondary|Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16 (Visit 8)|The change in 2-hour postprandial plasma glucose from baseline (Day 1) to Visit 8 (Week 16) was analyzed using a general linear model including treatment, and baseline HbA1c stratum (< 9% or ≥ 9%) as fixed factors, and the baseline 2-hour postprandial plasma glucose concentrations as a covariate.|Baseline to Week 16|Meal Test Evaluable Population: The Meal Test Evaluable Population consists of all modified ITT subjects who participated in the meal test, consumed at least 75% of the standardized meal and had no missing 2-hour postprandial glucose measurements at both Visit 3 (Day 1) and Visit 8 (Week 16), and have adequate study drug exposure.|||mg/dL||Standard Error|Least Squares Mean
2652408|NCT01652729|Secondary|Change in Body Weight (kg) From Baseline to Week 28|The change in body weight (kg) from baseline (Day 1) to Week 28/Study Termination.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.|||kg||Standard Error|Least Squares Mean
2652409|NCT01652729|Secondary|Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28|The change in fasting plasma glucose concentrations from baseline (Day 1) to Week 28/Study Termination.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.|||mg/dL||Standard Error|Least Squares Mean
2652410|NCT01652729|Secondary|Percentage of Subjects Achieving HbA1c <7% at Week 28|Percentage of subjects achieving HbA1c target values of < 7.0% at Week 28/Study Termination.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.|||percentage of subjects|||Number
2652411|NCT01652729|Primary|Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28|Absolute change in HbA1c from baseline (Day 1, Visit 3) to Week 28/Study Termination (Visit 11). Hypothesis testing on the primary endpoint followed a serial gated procedure with all tests carried out at a 2-sided significance level of 0.05 to protect the family-wise error rate. These tests were conducted sequentially, and are presented in the statistical analysis section below in the order in which they were performed; each test was the gatekeeper of later tests.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.|||percentage of total hemoglobin||Standard Error|Least Squares Mean
2652412|NCT01652716|Secondary|Change in 2-hour Postprandial Glucose Concentrations From Baseline to Week 16|Change in 2-hour postprandial glucose concentrations from baseline to Week 16.|Baseline to Week 16|Meal Test Evaluable Subjects: Subjects who were randomized and received at least one dose of study drug and who participated in the meal test at Visit 3 and Visit 13, had adequate and reliable data for the postprandial data evaluation, and had adequate study medication exposure.|||mg/dL||Standard Error|Least Squares Mean
2652413|NCT01652716|Secondary|Change in Body Weight (kg) From Baseline to Week 28|Change in body weight (kg) from baseline to Week 28/Study Termination.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.|||kg||Standard Error|Least Squares Mean
2652414|NCT01652716|Secondary|Change in Fasting Plasma Glucose Concentrations From Baseline to Week 28|Change in fasting plasma glucose concentrations from baseline to Week 28/Study Termination|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.|||mg/dL||Standard Error|Least Squares Mean
2652415|NCT01652716|Secondary|Percentage of Subjects Achieving HbA1c <7% at Week 28|Percentage of subjects achieving HbA1c <7% at Week 28/Study Termination|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug.|||Percentage of subjects|||Number
2652416|NCT01652716|Primary|Change in HbA1c (Glycosylated Hemoglobin) From Baseline to Week 28|The primary objective of this study was to compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus.|Baseline to Week 28|Modified Intent-to-Treat: Subjects who were randomized and received at least one dose of study drug|||Percentage of total hemoglobin||Standard Error|Least Squares Mean
2652425|NCT01652690|Secondary|Number of Participants With Serious ADRs to Denosumab|"Serious adverse events that were considered related to denosumab were classified as serious adverse drug reactions (SADRs). A serious adverse event (SAE) is any AE that also: • is fatal • is life threatening (places the patient at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is an other significant medical hazard that does not meet any of the above criteria."|24 months|Full analysis set|||participants|||Number
2652426|NCT01652690|Secondary|Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab|Adverse events (AEs) that were considered related to denosumab as evaluated by the investigator were classified as adverse drug reactions (ADRs).|24 months|Full analysis set|||participants|||Number
2652427|NCT01652690|Primary|Number of Participants Having Osteoporosis Related Laboratory Examinations|Number of participants having osteoporosis related laboratory examinations pre-treatment with denosumab and during the study. Participants may not have been given denosumab injection when they attended each visit.|Pre-baseline (before first denosumab injection) and post-baseline|Full analysis set; n = participants with visits at each time point.|||participants|||Number
2652428|NCT01652690|Primary|Number of Participants Having Radiologic Bone Assessments|Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.|Pre-baseline (before first denosumab injection) and during the study (post-baseline)|Full analysis set|||participants|||Number
2652429|NCT01652690|Primary|Number of Denosumab Post-baseline Injections Received by Each Participant||24 months|Full analysis set|||participants|||Number
2652430|NCT01652690|Primary|Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the fourth post-baseline injection.|Month 24|Full analysis set participants who received a fourth post-baseline injection (i.e. at month 24)|||participants|||Number
2652431|NCT01652690|Primary|Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the third post-baseline injection.|Month 18|Full analysis set participants who received a third post-baseline injection (i.e. at month 18)|||participants|||Number
2652432|NCT01652690|Primary|Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the second post-baseline injection.|Month 12|Full analysis set participants who received a second post-baseline injection (i.e. at month 12)|||participants|||Number
2652433|NCT01652690|Primary|Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the first post-baseline injection.|Month 6|Full analysis set participants who received a first post-baseline injection (i.e. at month 6)|||participants|||Number
2652434|NCT01652690|Primary|Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection|Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection.|Baseline (day 1)|Full analysis set|||participants|||Number
2652435|NCT01652690|Primary|Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care||24 months|Full analysis set participants who discontinued the study prematurely|||participants|||Number
2652436|NCT01652690|Primary|Number of Participants Receiving All Prescriptions and Injections of Denosumab|Number of participants receiving all prescriptions and injections of denosumab whether or not the injections are given at the initial prescribing physician's office.|Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)|Full analysis set|||participants|||Number
2652437|NCT01652690|Primary|Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection||Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)|Full analysis set; n = the number of participants who received the corresponding injection|||participants|||Number
2652438|NCT01652690|Primary|Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office|Number of participants who received all injection(s), including baseline injection, from the initial prescribing site irrespective of total number of injections received on study.|24 months|Full analysis set (all enrolled patients who provided informed consent and received at least one injection)|||participants|||Number
2652439|NCT01652664|Primary|Mean Change From Baseline in IOP at Month 3|IOP (fluid pressure inside the eye) was assessed using a calibrated tonometer and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye from each participant was chosen as the study eye and only the study eye was used for analysis.|Baseline (Day 0), Month 3|All participants who received study drug and completed at least 1 scheduled on-therapy visit. No imputation was used, therefore the analysis included only observed cases.|||mmHg||Standard Error|Mean
2652440|NCT01652573|Secondary|Number of Participants With Allergic Reactions at 3 Months|This symptom will be assessed.|Time 3 months||||Participants|||Count of Participants
2652441|NCT01652573|Secondary|Number of Participants With Nasal Ulcerations at 3 Months|This symptom will be assessed.|Time 3 months||||Participants|||Count of Participants
2652442|NCT01652573|Secondary|Number of Participants With Allergic Reactions at 2 Months|This symptom will be assessed.|Time 2 months||||Participants|||Count of Participants
2652443|NCT01652573|Secondary|Number of Participants With Nasal Ulceration at 2 Months|This symptom will be assessed.|Time 2 months||||Participants|||Count of Participants
2652444|NCT01652573|Secondary|Number of Participants With Allergic Reactions at 1 Month|This symptom will be assessed.|Time 1 month||||Participants|||Count of Participants
2652445|NCT01652573|Secondary|Number of Participants With Nasal Ulceration at 1 Month|This symptom will be assessed.|Time 1 month||||Participants|||Count of Participants
2652460|NCT01652534|Secondary|Fatigue Severity Scale (FSS)|A questionnaire used to discriminate between Parkinson Disease (PD) patients with fatigue and those without fatigue. Range 9 to 63, higher scores indicate greater fatigue severity.|Baseline, change in 4 weeks|Participants who completed questionnaire|||score on a scale||Full Range|Mean
2652461|NCT01652534|Secondary|Gait Analysis Testing|Use of an accelerometer such as Motorola Droid and wireless acceleration sensors to record gait parameters step time, walking speed, and cadence during the timed up and go (TUG) and modified timed up and go (mTUG) components. The sensors will be attached to the subject's legs and trunk using Velcro straps. The accelerometer will be held or clipped onto the subject in order to measure his or her acceleration. This is done within clinic and during the visit time.|Baseline, week 4, week 7, week 11|No data was collected from the portable devices that were used.||||||
2652462|NCT01652534|Secondary|Parkinson's Disease Questionnaire-39 (PDQ-39)|The Parkinson's Disease Questionnaire-39 (PDQ39) is a copyrighted instrument to assess symptoms of Parkinson's disease (PD) with 39 questions relating to mobility, activities of daily living, emotional well-being, social support, cognition, communication and bodily discomfort. The test asks subjects to rate each question regarding their Parkinson's disease symptoms over the past month. (range 0 to 100, lower scores reflect better quality of life)|Baseline, week 4|Participants completing questionnaire|||score on a scale||Full Range|Mean
2652463|NCT01652534|Secondary|Clinical Global Impression (CGI)|"Global Improvement is the second scale in the clinical global impression (CGI). Total overall improvement is judged by whether or not, in the judgment of the assessor, the improvement is entirely due to the drug treatment. It is also a 1-7 point weighted scale, going from very much improved (1) to very much worse (7). A zero score is assigned if the score is not assessed."|4 weeks|number completing study up to assessment|||score on a scale||Full Range|Median
2652464|NCT01652534|Secondary|Freezing of Gait Questionnaire|"A questionnaire that is used to assess the likelihood of the subject freezing in a number of different scenarios.~0=No freezing of gait to 24=severe freezing of gait"|Baseline, change in 4 weeks|Participants who completed questionnaire|||score on a scale||Full Range|Median
2652465|NCT01652534|Secondary|Analysis of Motor Functioning Using the Parkinson's Home Diaries|"Subject will record motor activity as OFF, ON (mobility improved) or asleep on the diary every half hour for two days. Subjects further define ON time according to dyskinesia categories none, non-troublesome or troublesome. The home diaries are used as an evaluation measure of the intervention by assessing the change in off time and change in on time with troublesome dyskinesia. The difference in time experiencing dyskinesia while ON meds relative to the time OFF meds at baseline and at 4 weeks is compared."|Baseline, change in 4 weeks|"patients who report being ON and OFF medication and experience dyskinesia under either condition at baseline and after 4 weeks of either Amantadine or Placebo.~NOTE: only one patient reported both dyskinesia at baseline and 4 weeks and only under the placebo condition. Others did not report any OFF time, so the difference could not be calculated."|||minutes||Standard Deviation|Median
2652466|NCT01652534|Secondary|Modified Timed Up and Go (mTUG)|The subject sits in the chair approximately 3 1/2 meters away from doorway with the door closed. Subject then stands up and walks one meter to a 40cm X 40cm box taped on the floor. Within the box the patient turns clockwise (360 degrees), then turns counterclockwise (360 degrees). Walk to open the door and walk through the doorway, turn around and return to the chair. Modified Timed Up and Go (mTUG) completed in three components including walking the course without additional tasks, carrying a tray with a cup of water, and counting backwards from 100, in both ON and OFF state.|Baseline, change in 4 weeks|participants who completed task|||seconds||Standard Deviation|Mean
2652467|NCT01652534|Primary|Timed Up and Go (TUG) - OFF Usual Medication|This is a walking assessment. The subject will begin in the seated position, stand up, walk 7 meters, turn around, and sit back down. The entire process from leaving the chair to returning to the chair will be timed. Also, the Timed Up and Go (TUG) will be done both in the ON and OFF states.|Baseline, change at 4 weeks|participants who could complete the task.|||seconds||Full Range|Median
2652468|NCT01652534|Primary|Timed Up and Go (TUG) - ON Usual Medication|This is a walking assessment. The subject will begin in the seated position, stand up, walk 7 meters, turn around, and sit back down. The entire process from leaving the chair to returning to the chair will be timed. Also, the Timed Up and Go (TUG) will be done both in the ON and OFF states.|Baseline, change at 4 weeks|participants who could complete the task. Note: for the 2 participants who were tested while on placebo, one did not complete baseline, and one did not complete week 4, so a change could not be computed.|||seconds||Full Range|Median
2652469|NCT01652495|Secondary|Reduction of Pain Severity Expressed as Percentage Change in VAS Score|"VAS score~VAS score is a 10 -cm graduated scale with scores ranging from 0 (no pain) to 10 (unbearable pain) self- reported by patients~Reference: Langley GB and Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int 1985;5(4):145-148."|180 days after treatment||||percentage of pain reduction||95% Confidence Interval|Mean
2652470|NCT01652495|Secondary|Percentage of Patients With Suppression of Hypothalamus-pituitary-adrenal Axis|"Evaluation of blood cortisol and ACTH, free urinary cortisol, urinary levels of methylprednisolone or triamcinolone (depending on the administered drug) by RIA immunoassay and tandem mass assays~Persistent suppression of the HPA axis at the end of the follow up is based on the evidence of ACTH, plasmatic and urinary cortisol levels under reference values"|45 days after treatment||||% of patients with HPA suppression|||Number
2652471|NCT01652495|Primary|Functional Improvement Measured According to Percentage Change in Constant Score|"Patients will be evaluated clinically by Constant Score~Constant score: range 0 (total shoulder impairment) to 100 (non impaired shoulder). The score is obtained from two subjective (pain and relation between pain and daily-life activities) - and two objective physician-assessed (strength and range of motion) measurements~Reference: Constant CR and Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4."|180 days after treatment||||percentage of improvement Constant score||95% Confidence Interval|Mean
2652472|NCT01652469|Secondary|Number of Participants With Adverse Events|Adverse events classified according to NCI CTCAE version 4|Same as primary outcome: 24 months|One patient from the Docetaxel arm never started treatment.|||Participants|||Count of Participants
2652473|NCT01652469|Secondary|Disease Control|Disease control is defined as achieving objective response or stable disease for at least 6 weeks.|Same as primary outcome: 24 months||||Participants|||Count of Participants
2652474|NCT01652469|Secondary|Objective Response|Objective response is defined as best overall response (CR or PR) across all assessment time-points according to RECIST Criteria 1.1 during the period from randomization to termination of trial treatment.|Same as primary outcome: 24 months||||Participants|||Count of Participants
2652475|NCT01652469|Secondary|Overall Survival|Defined as time from the date of randomization until death from any cause.|All patients will be followed for survival status every 12 weeks up to 24 months after the last patient is randomized||||months||95% Confidence Interval|Median
2652476|NCT01652469|Primary|Progression-free Survival|"Time from the date of randomization until documented progression or death without documented progression.~Assessment of Progressive Disease (PD) based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) Target lesions:At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.(Note: the appearance of one or more new lesions is also considered progression).~Non-target lesions:Unequivocal progression of existing non-target lesions. (Note:the appearance of one or more new lesions is also considered progression). To achieve 'unequivocal progression', there must be an overall level of substantial worsening in non-target disease such that,even in presence of SD or PR in target disease, the overall tumour burden has increased sufficiently"|The combined run in period, treatment and follow-up for PFS is expected to extend the study duration to a total of 24 months.||||months||95% Confidence Interval|Median
2652477|NCT01652287|Other Pre-specified|Changes in Composition of the Microbial Community|The secondary aim was to evaluate the influence of BB-12®-supplemented yogurt and control yogurt on the fecal microbiota of participants and determine any changes in the composition of the microbial community.|Day 10|||||||
2652478|NCT01652287|Primary|Number of Adverse Events|The primary outcome is to assess the safety of BB-12® yogurt when consumed by generally healthy children. To achieve this aim, data on adverse events will be collected from diaries; calls to the 24-hour advice line; and research assistant phone calls on days 6, 11, 15 and 180, ±2 days. All adverse events will be tabulated by type and charted over time.|Days 0-180||||Number of AE reported|||Number
2652479|NCT01652040|Secondary|Metabolic Profile|Basal Metabolic Rate|16 weeks||||kcal/day||Standard Deviation|Mean
2652480|NCT01652040|Primary|Body Composition|Changes in body composition fat mass|16 weeks||||percentage of fat mass||Standard Deviation|Mean
2652481|NCT01652001|Secondary|Sialometries|"Unstimulated and stimulated salivary flow rates were assessed in all patients. The unstimulated salivary flow rate was obtained by the spit method every 30 seconds for 15 minutes. Saliva was collected in 20 mL plastic containers, which were pre-weighted.~Stimulated whole saliva was obtained by chewing a 1 g piece of paraffin wax for six minutes. Saliva collected during the first minute was discarded, and then collected into the container every 30 seconds."|2 weeks||||mL/min||Standard Deviation|Mean
2652482|NCT01652001|Primary|Dry Mouth Questionnaire (DMQ)|"Dry Mouth Questionnaire (DMQ) was used in order to obtain subjective information about the severity of xerostomia before and after treatment with malic acid/placebo.~Every participant answered an initial questionnaire (DMQ 1) about the symptoms related to oral dryness, before receiving a spray (1% malic acid or placebo). After two weeks of applications, patients had to answer DMQ 1 again as well as an additional questionnaire (DMQ 2) about the efficacy of the sprays. Increased DMQ scores indicate improvement of xerostomia. DMQ 1 was used to assess the initial severity of oral dryness and in particular its impact on oral function: problems when chewing, swallowing, speaking and general impact on daily life.~DMQ 1 used a 0-to-4 rating scale where 0 = very dry and 4 = not dry at all. After two weeks of treatment, DMQ 1 was repeated and it was included DMQ 2.~At the end values of DMQ 1 and DMQ 2 were summed"|2 weeks||||units on a scale||Standard Deviation|Mean
2652483|NCT01651949|Primary|Percentage of Participants Who Had Study Vaccine Discontinued Due to an Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.|Up to Month 12|The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.|||Percentage of Participants|||Number
2652484|NCT01651949|Primary|Percentage of Participants With an Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE.|Up to Month 12|The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.|||Percentage of Participants|||Number
2652485|NCT01651949|Secondary|Percentage of Participants With Seroconversion to the HPV Types Contained in the 9vHPV Vaccine|Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30; HPV Type 11: ≥16; HPV Type 16: ≥20; HPV Type 18: ≥24; HPV Type 31: ≥10; HPV Types 33, 45, 52, and 58: ≥8.|Four weeks post vaccination 3 (Month 7)|The analysis set includes participants who received the 3 vaccinations, were seronegative to the appropriate HPV type at baseline, and had Month 7 immunogenicity results for the appropriate HPV type. Per-protocol non-inferiority analysis compared heterosexual males and females only.|||Percentage of Participants||95% Confidence Interval|Number
2652486|NCT01651949|Primary|Percentage of Participants With Elevated Oral Body Temperature (>=37.8° C, >=100° F)|Participants were instructed by the investigator to use the Vaccination Report Card to document evening oral temperature daily after each study vaccination|Up to 5 days after any vaccination|The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.|||Percentage of Participants|||Number
2652560|NCT01651117|Secondary|Change in Direct LDL Blood Levels|Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)|Baseline to 12 months||||mg/dL||95% Confidence Interval|Mean
2652487|NCT01651949|Primary|Percentage of Participants With One or More Injection-site Adverse Experiences Prompted on the Vaccination Report Card|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling. Participants were instructed to use the Vaccination Report Card to record AEs daily after each study vaccination.|Up to 5 days after any vaccination|The analysis set includes all participants who received >=1 vaccination and had safety follow-up. Heterosexual and MSM males were combined for safety outcomes.|||Percentage of Participants|||Number
2652488|NCT01651949|Primary|Geometric Mean Titers (GMTs) to the HPV Types Contained in the 9vHPV Vaccine|Serum antibodies to HPV types 6/11/16/18/31/33/45/52/58 were measured with a Competitive Luminex Immunoassay. Titers are reported in milli Merck Units/mL|Four weeks post vaccination 3 (Month 7)|The analysis set includes heterosexual male and female participants who received the 3 vaccinations, were seronegative to the appropriate HPV type at baseline, and had Month 7 immunogenicity results for the appropriate HPV type. Per-protocol non-inferiority analysis compared heterosexual males and females only.|||milli Merck Units/mL||95% Confidence Interval|Geometric Mean
2652489|NCT01651936|Secondary|Change From Baseline in the HAQ Disability Index at Week 24|The functional status of the participant was assessed using the Disability Index of the HAQ on a Likert scale. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. The overall score for the Disability Index is the mean of the 8 functional area scores and also ranges from 0 to 3, with a lower score indicating less disability. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.|Baseline and Week 24|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
2652490|NCT01651936|Secondary|Percentage of Participants Achieving an ACR50 Response at Week 24|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR50 response is defined as a ≥50% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0=Absent; 1=Present) and 2) ≥50% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, 0=no pain to 100=extreme pain); b) Patient's Global Assessment of Disease Activity VAS (0=doing very well to 100=doing very poor); c) Investigator's Global Assessment of Disease Activity VAS (0=doing very well to 100=doing very poor; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from 0=no difficulty to 24=inability to perform tasks; and e) CRP (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 24|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
2652491|NCT01651936|Secondary|Change From Baseline in the Health Assessment Questionnaire Disability (HAQ Disability Index) at Week 12|The functional status of the participant was assessed using the Disability Index of the HAQ on a Likert scale. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. The overall score for the Disability Index is the mean of the 8 functional area scores and also ranges from 0 to 3, with a lower score indicating less disability. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in the Base Study who received at least one dose of study drug and had both Baseline and Week 12 HAQ Disability Index measurement|||Units on a scale||95% Confidence Interval|Least Squares Mean
2652492|NCT01651936|Secondary|Change From Baseline in DAS28-CRP at Week 24|The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints; 0=absent, 1=present; TEN28), swollen joints (28 joints; 0=absent, 1=present; SW28), CRP (decrease indicates improvement), and Patient's Global Assessment of Disease Activity Visual Analog Scale (VAS) (0=doing very well to 100=doing very poor; GH, ). It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. This outcome measure applied to Base Study participants only.|Baseline and Week 24|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
2652493|NCT01651936|Secondary|Percentage of Participants Achieving an ACR50 Response at Week 12|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR50 response is defined as a ≥50% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥50% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in the Base Study who received at least one dose of study drug and had at least one post-baseline ACR50 measurement (last observation carried forward)|||Percentage of participants|||Number
2652561|NCT01651117|Secondary|Change in Glucose Control|Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)|Baseline to 12 months||||percent||95% Confidence Interval|Mean
2652494|NCT01651936|Secondary|Percentage of Participants Achieving an ACR20 Response at Week 24|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR20 response is defined as a ≥20% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥20% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 24|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
2652495|NCT01651936|Secondary|Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR20 response is defined as a ≥20% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥20% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in the Base Study who received at least one dose of study drug and had at least one post-baseline ACR20 measurement (last observation carried forward)|||Percentage of participants|||Number
2652496|NCT01651936|Primary|Change From Baseline in Disease Activity Score (DAS28) as Measured by C-Reactive Protein (CRP) at Week 12|The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints; 0=absent, 1=present; TEN28), swollen joints (28 joints; 0=absent, 1=present; SW28), CRP (an inflammatory marker, decrease indicates improvement), and Patient's Global Assessment of Disease Activity Visual Analog Scale (VAS) (0=doing very well to 100=doing very poor; GH). It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in the Base Study who received at least one dose of study drug and had both Baseline and Week 12 DAS28-CRP measurements|||Units on a scale||95% Confidence Interval|Least Squares Mean
2652497|NCT01651806|Primary|Document Incidences of DVT and Other Thromboembolic Events.|"DVT = Deep Venous thrombosis~Patients were assessed every 12 hours for development of pain within the lower extremity. Any reported muscle pain was evaluate with a bedside venous ultrasound by an ultrasound technician."|1 year||||Events|||Number
2652498|NCT01651806|Primary|Primary Intra-operative Blood Loss|Record intra-operative blood loss through drain output|Intra-operative, an average of 3 hours||||mL||Standard Deviation|Mean
2652499|NCT01651793|Secondary|Vigor Symptoms (Profile of Mood State)|Vigor subscale scores from the Profile of Mood States.The higher the score the greater the feelings of energy. The scores range from a minimum of 0 to a maximum of 20.|Pre and 90, 120 and 160 minutes post intervention||||units on a scale||Standard Deviation|Mean
2652500|NCT01651793|Primary|Performance on Bakan Task|"Performance on Bakan Task at baseline, post-test 1, post-test 2, and post-test 3~Bakan test presents numbers on a computer screen. Participant presses one button whenever the number 6 appears and a different button whenever three odd and different numbers in a row occurs such as 7 5 9. The number of times the participant does this correctly the better the performance. The scores range from 0 to 10 because the sequence of three odd and different numbers occurs a total of 10 times."|baseline, post 60, post 90, post 120||||units on a scale||Standard Deviation|Mean
2652501|NCT01651793|Primary|Correct Responses on Serial 7 Subtraction Task|Participants subtract the number 7 from a three digit number and quickly and accurately as possible for 60 seconds. The total number of accurate responses is scored. The higher the score the better performance. The range of scores is from a minimum score of 0 to a theoretical maximum score of 120.|Pre and 30, 60 and 120 minutes post intervention||||Correct responses||Standard Deviation|Mean
2652502|NCT01651780|Secondary|Bleeding BARC 3a, BARC Types 1 or 2, and TIMI Minor|The percentage of participants with moderate bleeding as defined by BARC 3a and minor bleeding as defined as BARC type 1 and 2 and TIMI minor is presented.|at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up|Participants in the ITT population.|||percentage of participants|||Number
2652503|NCT01651780|Secondary|Timing Effect on Bleeding Event Rate up to 48 Hours or Hospital Discharge|The effect of timing on bleeding event rates (the percentage of participants with an incidence of major bleeding) is presented.|Up to 48 hours after procedure or at hospital discharge (but also includes any subsequent hospitalizations)|"Participants in the ITT population with an incidence of major bleeding. Participants were categorized as First half of study site's enrolled participants (Bivalirudin, N=173; UFH, N=173) and Second half of study site's enrolled participants (Bivalirudin, N=171; UFH, N=165). Only sites with >20 participants are included in this analysis."|||percentage of participants|||Number
2652504|NCT01651780|Secondary|New Onset Atrial Fibrillation/Flutter|The percentage of participants reporting new onset atrial fibrillation/flutter is presented.|at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)|Participants in the ITT population.|||percentage of participants|||Number
2652505|NCT01651780|Secondary|Acquired Thrombocytopenia|The percentage of participants reporting acquired thrombocytopenia is presented.|at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)|Participants in the ITT population.|||percentage of participants|||Number
2652506|NCT01651780|Secondary|Major Vascular Complications|The percentage of participants reporting a major vascular complications as defined by VARC is presented.|at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)|Participants in the ITT population.|||percentage of participants|||Number
2652509|NCT01651780|Secondary|Major Bleeding According to Additional Scales (VARC, TIMI, GUSTO, ACUITY/HORIZONS)|"Percentage of participants with major bleeding according to the following scales:~Valve Academic Research Consortium (VARC)=life threatening, disabling bleeding, or major bleeding~Thrombolysis in Myocardial Infarction (TIMI)=major bleeding~Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)=severe or moderate~Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY)/Harmonizing Outcomes with RevasculariZatiON and Stents (HORIZONS)=major bleeding"|at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up|Participants in the ITT population.|||percentage of participants|||Number
2652510|NCT01651780|Secondary|Major Adverse Cardiac Events (MACE) Including Death, Non-fatal MI, and Stroke|The percentage of participants reporting a MACE overall and the individual components of MACE (including death, non-fatal MI, and stroke) are presented.|at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)|Participants in the ITT population.|||percentage of participants|||Number
2652511|NCT01651780|Secondary|NACE at 48 Hours or Before Hospital Discharge|NACE at 48 hours or before hospital discharge is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, MI, and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint.|at 48 hours or before hospital discharge, whichever occurred earlier|Participants in the ITT population.|||percentage of participants|||Number
2652512|NCT01651780|Primary|Net Adverse Clinical Events (NACE) at up to 30 Days|The net adverse cardiac events (NACE) at 30 days is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, myocardial infarction (MI), and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint.|up to 30 days after procedure|Participants in the ITT population.|||percentage of participants|||Number
2652513|NCT01651780|Primary|Major Bleeding (BARC ≥3b) at 48 Hours or Before Hospital Discharge|"Major bleeding (Bleeding Academic Research Consortium [BARC] type ≥3b) was defined as follows:~Bleeds that were evident clinically, or by laboratory or imaging results, which resulted in surgical intervention or administration of IV vasoactive drugs; overt bleeds with a hemoglobin drop of at least 5 grams per deciliter (g/dL); and bleeding that caused cardiac tamponade.~BARC 3c includes intracranial or intraocular bleeds that compromised vision.~BARC type 4 (Coronary Artery Bypass Grafting [CABG]-related bleeding) includes perioperative intracranial bleeding within 48 hours, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 units of whole blood or packed red blood cells within a 48 hour period; and chest tube output ≥2 liters (L) within a 24-hour period.~BARC type 5, fatal bleeding, describes bleeds that directly result in death with no other cause."|at 48 hours or discharge, whichever occurs first|Participants in the ITT population.|||percentage of participants|||Number
2652514|NCT01651442|Primary|Percent of Participants Who Met Remission as Measured by the Insomnia Severity Index|The Insomnia Severity Index (ISI) is a self-report questionnaire assessing the nature, severity, and impact of insomnia. Remission is determined to be a score less-than 8.|6 weeks, 12 weeks, 3 months, 6 months, 9 months & 12 months||||percent remitted|||Number
2652515|NCT01651403|Secondary|Percent Change From Baseline in Bone Mineral Density of Spine||Baseline; Week 48|Participants in the Spine DXA Analysis Set with available data were analyzed.|||Percent change in spine BMD||Standard Deviation|Mean
2652516|NCT01651403|Secondary|Percentage of Participants With ≥ 4% Decrease From Baseline in Spine Bone Mineral Density||Baseline; Week 48|Spine Dual X-Ray Absorptiometry (DXA) Analysis Set: all randomized participants who received at least 1 dose of study drug and had nonmissing baseline spine bone mineral density values.|||percentage of participants|||Number
2652517|NCT01651403|Secondary|Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 144||Baseline; Week 144|||||||
2652518|NCT01651403|Secondary|Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with serum samples available at baseline and with HBV DNA ≥ 69 IU/mL at Week 96 were analyzed.|||Participants|||Count of Participants
2652519|NCT01651403|Secondary|Number of Participants With Sequence Changes From Baseline Within the HBV Polymerase for Participants Who Were Viremic (HBV DNA ≥ 400 Copies/mL [69 IU/mL]) Including Participants With Confirmed Virologic Breakthrough at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with serum samples available at baseline and with HBV DNA ≥ 69 IU/mL at Week 48 were analyzed.|||Participants|||Count of Participants
2652520|NCT01651403|Secondary|Percentage of Participants With HBsAg Seroconversion|HBsAg seroconversion was defined as HBsAg loss and a change from HBsAb negative or missing at baseline to HBsAb positive.|Week 48|Serologically Evaluable Full Analysis Set For HBsAg Loss/Seroconversion; The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2652521|NCT01651403|Secondary|Percentage of Participants With HBsAg Loss|HBsAg Loss was defined as a change from HBsAg positive or missing at baseline to HBsAg negative.|Week 48|Serologically Evaluable Full Analysis Set For HBsAg Loss/Seroconversion; The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2652522|NCT01651403|Secondary|Percentage of Participants With HBV DNA < 169 Copies/mL (29 IU/mL) at Week 48||Week 48|Full Analysis Set; The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2652523|NCT01651403|Secondary|Composite Endpoint of Percentage of Participants With HBV DNA < 400 Copies/mL (69 IU/mL) and Normalized ALT at Week 48|Normal alanine amino transferase (ALT) was defined as ≤ 30 U/L for males and females 0−12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.|Week 48|Participants in the Full Analysis Set with abnormal ALT values at baseline were analyzed. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2652524|NCT01651403|Secondary|Percentage of Participants With Normalized ALT at Week 48|Normal alanine amino transferase (ALT) was defined as ≤ 30 U/L for males and females 0−12 years based on the AASLD pediatric normal range. ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit.|Week 48|Participants in the Full Analysis Set with abnormal ALT values at baseline were analyzed. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2652525|NCT01651403|Secondary|Percentage of Participants With Normal ALT at Week 48|Normal alanine amino transferase (ALT) was defined as ≤ 30 U/L for males and females 0−12 years based on the American Association for the Study of Liver Diseases (AASLD) pediatric normal range.|Week 48|Full Analysis Set; The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2652526|NCT01651403|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48|HBeAg seroconversion was defined as HBeAg loss and a change from HBeAb negative or missing at baseline to HBeAb positive.|Week 48|Serologically Evaluable FAS For HBeAg loss/seroconversion: participants who were randomized and had received at least 1 dose of study drug, and with HBeAg positive and HBeAb negative or missing at baseline. The missing equals failure approach was used where all participants with missing data were considered to have failed to reach the endpoint.|||percentage of participants|||Number
2652527|NCT01651403|Primary|Percentage of Participants With Serum HBV DNA < 400 Copies/mL (69 IU/mL) at Week 48||Week 48|Full Analysis Set (FAS): all randomized participants who have received at least 1 dose of study drug. Participants will be analyzed according to the treatment to which they were randomized.The missing equals failure approach was used where all participants with missing data were considered to have failed to achieve the endpoint.|||percentage of participants||95% Confidence Interval|Number
2652528|NCT01651351|Secondary|Number of Participants Testing Positive for Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Parvovirus B19 (PVB19) or Human Immunodeficiency Virus (HIV) Following Treatment With GLASSIA|Number of participants with seroconversion|105 days|Safety Analysis Set|||participants|||Number
2652529|NCT01651351|Secondary|Number of Possibly or Probably Related Adverse Events That Occurred Between 72 Hours and 14 Days After Infusion|Number of AEs that occurred between 72 hours and 14 day following an infusion and were deemed related to study product administration|72 hours post infusion to 14 days post infusion|Safety Analysis Set|||adverse events|||Number
2652530|NCT01651351|Secondary|Number of Possibly or Probably Related Adverse Events (AEs) That Began During an Infusion|Number of AEs that occurred during an infusion and were deemed related to study product administration|Day 1 and Day 15|Safety Analysis Set|||adverse events|||Number
2652531|NCT01651351|Secondary|Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 72 Hours of Completion of an Infusion|Number of infusions with temporally associated AEs with an onset time during or within 72 hours of infusion completion, regardless of causality assessment|Within 72 hours of the end of infusion|Safety Analysis Set|||Infusions|||Number
2652532|NCT01651351|Secondary|Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 24 Hours of Completion of an Infusion|Number of infusions with temporally associated AEs with an onset time during or within 24 hours of infusion completion, regardless of causality assessment|Within 24 hours of the end of infusion|Safety Analysis Set|||Infusions|||Number
2652533|NCT01651351|Secondary|Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 1 Hour of Infusion Completion|Number of infusions with temporally associated AEs with an onset time during or within 1 hour of infusion completion, regardless of causality assessment|Within 1 hour of infusion completion|Safety Analysis Set|||Infusions|||Number
2652534|NCT01651351|Primary|Number of Infusions Associated With a Reduction in Infusion Rate or Discontinuation of Infusion Due to an Adverse Event (Regardless of Adverse Event Causality Assessment)||Day 1 and Day 15|Safety Analysis Set|||Infusions|||Number
2652535|NCT01651260|Secondary|Ease of Use|Likert scale score provided by clinician (1 very difficult, 2 difficult, 3 neither easy nor difficult, 4 easy, 5 very easy);|Between 1 - 14 days||||% rating with score of 4 and 5|||Number
2652536|NCT01651260|Primary|Prevention of Damage and/or Occlusion of Endotracheal (ET) Tube During Use|Number of participants with damage of ET tube and Number of participants with occlusion of ET tube|14 days||||participants|||Number
2652537|NCT01651208|Secondary|4-Item Morisky Medication Adherence Scale (MMAS-4)|The Morisky 4-Item Medication Adherence Scale (MMAS-4) is a self-reported measure of medication-taking behavior. Available in 33 languages, it addresses barriers to medication-taking. Each question can be answer as Yes or No for a range of 0-4 points.|At 12 month post stent placement||||Score on a Scale||Standard Deviation|Mean
2652538|NCT01651208|Primary|Number of Participants With Appropriate Adherence/ Medication Possession Ratio (MPR)|Medication Possession ratio (MPR) is a continuous multiple interval measure of medication availability. This is a validated method of estimating medication adherence . The medication possession ratio is defined as the sum of the days' supply of medication divided by the number of days between the first fill and the last refill plus the days' supply of the last refill.We will use the previously validated cutpoint of MPR>=.80 to define the binary outcome of Appropriate Adherence|12 months after receiving coronary stent||||participants|||Number
2652603|NCT01651000|Secondary|Subjects in the Intent to Treat Population With Normal Serum Total 25-hydroxyvitamin D|Subjects in the Intent to Treat Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/dL)|Approximately 6 months|Intent to treat|||participants|||Number
2652539|NCT01651117|Secondary|Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors)|As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)|Baseline to 12 months|After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).|||score on a scale||95% Confidence Interval|Mean
2652540|NCT01651117|Secondary|Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors)|Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)|Baseline to 12 months|After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).|||score on a scale||95% Confidence Interval|Mean
2652541|NCT01651117|Secondary|Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors)|Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month BP is lower than the baseline BP. (Change = final measure - initial measure)|Baseline to 12 months|After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).|||mmHG||95% Confidence Interval|Mean
2652542|NCT01651117|Secondary|Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors)|Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)|Baseline to 12 months|After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).|||mg/dL||95% Confidence Interval|Mean
2652543|NCT01651117|Secondary|Change in Glucose Control (Stage 2: Non-mentors v. Mentors)|Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)|Baseline to 12 months|After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).|||percent||95% Confidence Interval|Mean
2652544|NCT01651117|Secondary|Change in Depression Symptoms (Stage 2: Non-mentors v. Mentors)|As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)|Baseline to 6 months|After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).|||score on a scale||95% Confidence Interval|Mean
2652545|NCT01651117|Secondary|Change in Diabetes Quality of Life (Stage 2: Non-mentors v. Mentors)|Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)|Baseline to 6 months|After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).|||score on a scale||95% Confidence Interval|Mean
2652546|NCT01651117|Secondary|Change in Systolic Blood Pressure (Stage 2: Non-mentors v. Mentors)|Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month BP is lower than the baseline BP. (Change = final measure - initial measure)|Baseline to 6 months|After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).|||mmHG||95% Confidence Interval|Mean
2652699|NCT01649765|Secondary|Area Under Curve of Belimumab at Steady State (AUC, ss)|The PK model was fitted to the observed serum concentration-time data. The AUC values reported in this table are model derived values at ss, assuming a 10 mg/kg dose administered once every 28 days.|28-days dosing interval at steady state|PK Population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2652547|NCT01651117|Secondary|Change in Direct LDL Blood Levels (Stage 2: Non-mentors v. Mentors)|Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)|Baseline to 6 months|After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).|||mg/dL||95% Confidence Interval|Mean
2652548|NCT01651117|Secondary|Change in Depression Symptoms (Stage 2: Usual Care v. Mentees)|As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)|Baseline to 12 months||||score on a scale||95% Confidence Interval|Mean
2652549|NCT01651117|Secondary|Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee)|Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)|Baseline to 12 months||||score on a scale||95% Confidence Interval|Mean
2652550|NCT01651117|Secondary|Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee)|Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month BP is lower than the baseline BP. (Change = final measure - initial measure)|Baseline to 12 months||||mmHG||95% Confidence Interval|Mean
2652551|NCT01651117|Secondary|Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees)|Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)|Baseline to 12 months||||mg/dL||95% Confidence Interval|Mean
2652552|NCT01651117|Secondary|Change in Glucose Control (Stage 2: Usual Care v. Mentees)|Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)|Baseline to 12 months||||percent||95% Confidence Interval|Mean
2652553|NCT01651117|Secondary|Change in Depression Symptoms (Stage 2: Usual Care v. Mentees)|As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)|Baseline to 6 months||||score on a scale||95% Confidence Interval|Mean
2652554|NCT01651117|Secondary|Change in Diabetes Quality of Life (Stage 2: Usual Care v. Mentee)|Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)|Baseline to 6 months||||score on a scale||95% Confidence Interval|Mean
2652555|NCT01651117|Secondary|Change in Systolic Blood Pressure (Stage 2: Usual Care v. Mentee)|Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month BP is lower than the baseline BP. (Change = final measure - initial measure)|Baseline to 6 months||||mmHG||95% Confidence Interval|Mean
2652556|NCT01651117|Secondary|Change in Direct LDL Blood Levels (Stage 2: Usual Care v. Mentees)|Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)|Baseline to 6 months||||mg/dL||95% Confidence Interval|Mean
2652557|NCT01651117|Secondary|Change in Depression Symptoms|As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)|Baseline to 12 months||||score on a scale||95% Confidence Interval|Mean
2652558|NCT01651117|Secondary|Change in Diabetes Quality of Life|Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)|Baseline to 12 months||||score on a scale||95% Confidence Interval|Mean
2652559|NCT01651117|Secondary|Change in Systolic Blood Pressure|Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 12 month BP is lower than the baseline BP. (Change = final measure - initial measure)|Baseline to 12 months||||mmHG||95% Confidence Interval|Mean
2652562|NCT01651117|Secondary|Change in Depression Symptoms|As measured by change in the Patient Health Questionnaire-2, adjusted for baseline score and patient random effects. The PHQ score is calculated by summing 2 4-point 0-3 Likert scale questions, and ranges from 0 to 6, with lower score indicating lower depression. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month PHQ is lower than the baseline PHQ. (Change = final measure - initial measure)|Baseline to 6 months||||score on a scale||95% Confidence Interval|Mean
2652563|NCT01651117|Secondary|Change in Diabetes Quality of Life Score|Change in Diabetes Distress Scale, adjusted for baseline score and patient random effects. The DDS score is calculated by averaging 2 5-point Likert scale questions, and ranges from 1 to 5, where lower means less distress. Values of the change variable can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month DDS is lower than the baseline DDS. (Change = final measure - initial measure)|Baseline to 6 months||||score on a scale||95% Confidence Interval|Mean
2652564|NCT01651117|Secondary|Change in Systolic Blood Pressure|Measured by change in systolic Blood Pressure, adjusting for baseline blood pressure and patient random effect. Systolic BP is measured as mmHG. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month BP is lower than the baseline BP. (Change = final measure - initial measure)|Baseline to 6 months||||mmHG||95% Confidence Interval|Mean
2652565|NCT01651117|Secondary|Change in Direct LDL Blood Levels|Measured by change in Direct LDL blood levels, adjusted for baseline LDL and patient random effect. LDL is measured as mg/dL. Values of the change variable (difference of 2 levels) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month LDL is lower than the baseline LDL. (Change = final measure - initial measure)|Baseline to 6 months||||mg/dL||95% Confidence Interval|Mean
2652566|NCT01651117|Primary|Change in Glucose Control (Stage 2: Non-mentors v. Mentors)|Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)|Baseline to 6 months|After 6 month of Stage 1, patients who were randomized to receive mentoring in Stage 1 were further randomized to either become a mentor in Stage 2 (Stage 2 Mentor) or to not become a mentor in Stage 2 (Stage 2 Non-mentor). Note that only those who had a 6-month follow-up visits for Stage 1 could be randomized to Stage 2 (139 participants).|||percent||95% Confidence Interval|Mean
2652567|NCT01651117|Primary|Change in Glucose Control (Stage 2: Usual Care v. Mentees)|Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)|Baseline to 6 months||||percent||95% Confidence Interval|Mean
2652568|NCT01651117|Primary|Change in Glucose Control (Stage 1: Usual Care v. Peer Mentoring)|Measured by change in HbA1c, adjusted for baseline HbA1c and patient random effects. HbA1c is measured as a percent. Values of the change variable (difference of 2 percentages) can be positive or negative. Negative change, which shows better outcome, occurs when the 6 month HBA1c is lower than the baseline HbA1c. (Change = final measure - initial measure)|Baseline to 6 months||||percent||95% Confidence Interval|Mean
2652569|NCT01651104|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination)|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after the aTIV vaccination.|From day 1 through day 4 postvaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
2652570|NCT01651104|Primary|Percentages of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of aTIV|"Immunogenicity was measured as the percentage of subjects achieving SRH area ≥25 mm2 against each of three vaccine strains at baseline (day 1) and three weeks after aTIV vaccination (day 22).~This criterion is met according to CHMP guideline if percentage of subjects achieving SRH area ≥25 mm2 is 60% (≥65 years)."|Day 1 and 22|Analysis was done on the PP set.|||Percentages of subjects||95% Confidence Interval|Number
2652571|NCT01651104|Primary|Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of aTIV|"Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination SRH geometric mean areas (GMAs), directed against each of three vaccine strains, three weeks after vaccination (day 22).~The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.0 (≥65 years)."|Day 22|Analysis was done on the PP set.|||Ratio||95% Confidence Interval|Number
2652572|NCT01651104|Primary|Percentages of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of aTIV|"Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay.~Seroconversion or significant increase in SRH area was defined as the percentage of subjects with a negative prevaccination serum (SRH area ≤4 mm2) to a postvaccination SRH area ≥25 mm2; or a significant increase in antibody titer from a non-negative prevaccination serum, i.e., at least a 50% increase in area.~The European (CHMP) criterion is met if percentage of subjects achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|Day 22|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||Percentages of subjects||95% Confidence Interval|Number
2652573|NCT01651078|Secondary|Percentage of Patients With Laser Ablation Related Adverse Events|To continue to monitor factors impacting the safe and efficacious use of NeuroBlate|All adverse events reported through 26 weeks post index procedure||||Participants|||Count of Participants
2652574|NCT01651078|Secondary|Overall Survival|To describe/estimate the overall survival after the NeuroBlate Procedure.|12 and 26 weeks post index procedure||||percentage of patients|||Number
2655556|NCT01624662|Secondary|Facial Pain or Pressure Score (7-day Instantaneous Morning)|Change from baseline in facial pain/pressure symptoms, as measured by AM and PM diary symptom scores|Week 16 of the double-blind treatment phase||||units on a scale||Standard Error|Least Squares Mean
2652575|NCT01651078|Secondary|Quality of Life (Change in The Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score.|FACT-Br questionnaire sub-scores (Physical well-being, social/family well-being, emotional well-being, functional well-being, brain cancer subscale) are summed together, leading to a FACT-Br total score on a scale from 0-200; larger scores indicate better overall quality of life. This outcome measured the FACT-Br score change from Baseline at both 12 and 26 weeks post NeuroBlate procedure (values at 12 and 26 weeks, respectively, minus value at baseline). Version 4 of the Fact-BR scoring guidelines were used.|baseline, 12 and 26 weeks post index procedure|Due to study attrition, the full cohort was unavailable for analysis.|||change in FACT-Br score||Full Range|Median
2652576|NCT01651078|Primary|Percentage of Patients With Progression-Free Survival (PFS)|To describe local (CNS) progression-free survival rate in patients with failed radiosurgery for brain metastases treated with the NeuroBlate System. Sites were requested to submit imaging to a centralized core laboratory for analysis. A total of 27 patients had images submitted--27/42 (64%) of patients submitted follow-up images at 12-weeks and 16/42 (38%) patients submitted follow-up imaging at 26 weeks. Due to the low submission of follow-up images at 26-weeks, 12-weeks and last follow-up are reported.|Images were collected at 12 and 26 weeks post index procedure.|Sites were requested to submit imaging to a centralized core laboratory for analysis. A total of 27 patients had images submitted--27/42 (64%) of patients submitted follow-up images at 12-weeks and 16/42 (38%) patients submitted follow-up imaging at 26 weeks.|||percentage of patients|||Number
2652577|NCT01651052|Other Pre-specified|Subject's Average Prothrombin Time|Laboratory Analysis of Prothrombin Time (PT) on blood drawn from subjects. The PT is a blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot.|Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years|This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.|||Seconds||Standard Deviation|Mean
2652578|NCT01651052|Other Pre-specified|Subject's Average Partial Thromboplastin Time|Laboratory Analysis of partial thromboplastin time (PTT) on blood drawn from subjects. PTT is a blood test that looks at how long it takes for the blood to clot.|Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years|This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.|||Seconds||Standard Deviation|Mean
2652579|NCT01651052|Other Pre-specified|Subject's Average International Normalized Ratio|"Laboratory Analysis of International Normalized Ratio (INR) on blood drawn from subjects.~The INR is a calculation based on results of a prothrombin time (PT). The PT is a blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot."|Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years|This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.|||Ratio||Standard Deviation|Mean
2652580|NCT01651052|Other Pre-specified|Subject's Average Serum Creatinine|Laboratory Analysis of Serum Creatinine on blood drawn from subjects. Creatinine blood test is a test that measures kidney function.|Baseline|This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.|||micromol/l||Standard Deviation|Mean
2652581|NCT01651052|Other Pre-specified|Subject's Average Plasma Free Hemoglobin|Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects. This blood test measures the level of free hemoglobin in the liquid part of the blood (the serum).|Baseline, 3-6 Months, and 1 through 5 Years|This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.|||mg/dl||Standard Deviation|Mean
2652582|NCT01651052|Other Pre-specified|Subject's Average Platelet Count|Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.|Baseline, 3-6 Months, and 1 through 5 Years|This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.|||10^3 platelets per microliter||Standard Deviation|Mean
2652583|NCT01651052|Other Pre-specified|Subject's Average Hematocrit Percentage|Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component(plasma) in the blood.|Baseline, 3-6 Months, and 1 through 5 Years|This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.|||percentage of red blood cells||Standard Deviation|Mean
2652584|NCT01651052|Other Pre-specified|Subject's Average Hemoglobin Count|Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.|Baseline, 3-6 months, and 1 through 5 years|This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.|||g/dl||Standard Deviation|Mean
2652585|NCT01651052|Other Pre-specified|Subject's Average Red Blood Cells Count|Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.|Baseline, 3-6 Months, and 1 through 5 Years|This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.|||10^6 cells/microliters||Standard Deviation|Mean
2652586|NCT01651052|Other Pre-specified|Subject's Average White Blood Cell Count|Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.|Baseline, 3-6 Months, and 1 through 5 Years|This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.|||10^3 cells/microliters||Standard Deviation|Mean
2652587|NCT01651052|Secondary|Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time|The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.|Baseline and 1 Year|This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.|||units on a scale||Standard Deviation|Mean
2652604|NCT01651000|Secondary|Number of Participants in the Per Protocol Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values|Number of subjects in the per protocol population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.|Approximately 6 months|Per protocol|||participants|||Number
2659949|NCT01585441|Secondary|Change in Serum Dihydrotestosterone (DHT) Concentration at Month 3 Compared to Baseline|The mean change is reported in picograms of DHT per milliliter of serum.|Month 3||||pg/mL||Standard Deviation|Mean
2652588|NCT01651052|Secondary|Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey|"The Medical Outcomes Study Short-Form 12 (SF-12) contains two components - the Physical Component Summary (PCS) and the Mental Component Summary (MCS).~The SF-12 Physical Component Summary questionnaire scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status.~The SF-12 Mental Component Summary scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status."|Baseline and one year follow-up|This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.|||units on a scale||Standard Deviation|Mean
2652589|NCT01651052|Secondary|Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. Patients with cardiac disease but without resulting limitation of physical activity.~Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.~Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.~Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.~Symptoms of heart failure or the anginal syndrome may be present even at rest."|3-6 Months and 1 through 5 Years compared to baseline|This outcome is reported for subjects who received the Model 11000 surgical aortic heart valve where data is available.|||Participants|||Count of Participants
2652590|NCT01651052|Secondary|Subject's Average Effective Orifice Area Measurements|Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.|Baseline through 5-Year (at each scheduled follow-up visit)|This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.|||Centimeters squared||Standard Deviation|Mean
2652591|NCT01651052|Secondary|Subject's Average Mean Gradient Measurements|Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.|Baseline through 5-Year (at each scheduled follow-up visit)|This outcome is reported for subjects who received a Model 11000 surgical aortic heart valve where data is available.|||mmHg||Standard Deviation|Mean
2652592|NCT01651052|Primary|Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)|Number of late events divided by the total number of late patient years x 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).|Events occurring >= 31 days and up through 5 years post-implant||||Percentage of events/late patient years|||Number
2652593|NCT01651052|Primary|Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)|Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100|Events occurring within 30 days of procedure||||percentage|||Number
2652594|NCT01651039|Secondary|Disease Control Rate for Lens Refractory Rate|The number of response rates in Len refractory participants with SD, MR, PR, VGPR, or CR|up to 4 years||||Participants|||Count of Participants
2652595|NCT01651039|Secondary|Disease Control Rate|The number of response rates participants with SD, MR, PR, VGPR, or CR|up to 4 years||||Participants|||Count of Participants
2652596|NCT01651039|Secondary|Clinical Benefit Rate for Len Refractory Patients|The number of response rates in Lens Refractory participants that have achieved MR, PR, VGPR, CR|up to 4 years|Only Len Refractory Patients|||Participants|||Count of Participants
2652597|NCT01651039|Secondary|Clinical Benefit Rate|The number of response rates in participants that have achieved MR, PR, VGPR, CR|up to 4 years||||Participants|||Count of Participants
2652598|NCT01651039|Secondary|Response Rates for Len Refractory Patients|"Response Rates evaluated using the International Uniform Response Criteria the International Myeloma Working Group (2003).~CR-Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and 5% plasma cells in bone marrow VGPR-Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90 or greater reduction in serum M-component plus urine M-component <100 mg per 24 h PR-50% reduction of serum M-protein and reduction in 24-h urinary M-protein by 90% or to <200 mg per 24 h MR-≥ 25% but < 49% reduction of serum M protein and reduction in 24 hour urine M protein by 50 - 89%, which still exceeds 200 mg/24hrs. In addition; if present at baseline, 25‐49% reduction in the size of soft tissue plasmacytomas also required No increase in size or number of lytic bone lesions.~SD-Not meeting criteria for CR, VGPR, PR or progressive disease PD-Laboratory or Biochemical Relapse increase of 25% from baseline"|up to 4 years||||Participants|||Count of Participants
2652599|NCT01651039|Secondary|Response Rates|"Response Rates evaluated using the International Uniform Response Criteria the International Myeloma Working Group (2003).~CR-Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and 5% plasma cells in bone marrow VGPR-Serum and urine M-component detectable by immunofixation but not on electrophoresis or 90 or greater reduction in serum M-component plus urine M-component <100 mg per 24 h PR-50% reduction of serum M-protein and reduction in 24-h urinary M-protein by 90% or to <200 mg per 24 h MR-≥ 25% but < 49% reduction of serum M protein and reduction in 24 hour urine M protein by 50 - 89%, which still exceeds 200 mg/24hrs. In addition; if present at baseline, 25‐49% reduction in the size of soft tissue plasmacytomas also required No increase in size or number of lytic bone lesions.~SD-Not meeting criteria for CR, VGPR, PR or progressive disease PD-Laboratory or Biochemical Relapse increase of 25% from baseline"|up to 4 years||||Participants|||Count of Participants
2652600|NCT01651039|Primary|Overall Response Rate for Len Refractory Patients|The primary endpoint will be the best overall response rate (ORR)|up to 4 years|Only Len Refractory Patients|||Participants|||Count of Participants
2652601|NCT01651039|Primary|The Best Overall Response Rate (ORR)|The primary endpoint will be the best overall response rate (ORR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 4 years||||Participants|||Count of Participants
2652602|NCT01651000|Secondary|Subjects in the Per Protocol Population With Normal Serum Total 25-hydroxyvitamin D|Subjects in the Per Protocol Population with normal serum total 25-hydroxyvitamin D (>/= 30 ng/mL)|Approximately 6 months|Per protocol|||participants|||Number
2652605|NCT01651000|Primary|Number of Participants in the Intent to Treat Population With Decrease in Plasma Intact Parathyroid Hormone (iPTH) of ≥30% From Pre-treatment Baseline Values|Number of subjects in the intent to treat population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.|Approximately 6 months|Intent to treat|||participants|||Number
2652606|NCT01650844|Primary|Average Number of Days Without Asthma Symptoms (Symptom Free Days)|The primary outcome measure is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of days without asthma symptoms (symptom free days) over 2 weeks, during each follow-up assessment during the peak winter season (November-March). Symptom free days are defined as 24 hour periods of no asthma symptoms including, coughing, wheezing, tightness in the chest or shortness of breath. The number of symptom free days will be reported by the child's caregiver.|Average number of days, over 2 weeks, during peak winter season (November-March), assessed over 4 years.||||Days||Standard Deviation|Mean
2652607|NCT01650831|Primary|Positive/Negative for H.Pylori With Modified BreathID|The amount of subjects that produced positive/negative results for H.pylori with modified BreathID|1 hour|Per protocol subjects tested with modified BreathID|||participants|||Number
2652608|NCT01650831|Primary|Positive/Negative for H.Pylori With Cleared BreathID|The amount of subjects that produced positive/negative results with cleared BreathID device|1 hour|Per protocol positive/negative when testing with marketed BreathID|||participants|||Number
2652609|NCT01650831|Primary|Percentage of Patients With Dichotomous (Presence/Absence of H.Pylori) Outcome Agreement in Diagnosis of H. Pylori|The marketed (cleared) BreathID device and the investigational modified new generation BreathID device will measure simultaneously before (baseline) and after ingestion of substrate. The subject will be connected to both devices. The maximum time of measurement is 25 minutes.|25 minutes|Only subjects that had no recent knowledge of existing H.pylori infection and who met all protocol criteria and had no major protocol deviations, were included in the final analysis set (PP-per protocol).|||Percentage of participants||95% Confidence Interval|Number
2652610|NCT01650805|Secondary|Overall Survival|To compare, according to treatment with ponatinib versus imatinib, overall survival|Up to 8 years after the last patient's first dose|||||||
2652611|NCT01650805|Secondary|Progression-free Survival|To compare, according to treatment with ponatinib versus imatinib, progression-free survival|Up to 8 years after the last patient's first dose|||||||
2652612|NCT01650805|Secondary|Complete Cytogenetic Response (CCyR) Rate|The percentage of Ph+ metaphases in bone marrow (peripheral blood may not be used), with a review of a minimum of 20 metaphases. Responses are defined as follows: Complete (CCyR): 0% Ph+ metaphases.|12 months after first dose|Patients with 12 month assessment|||participants|||Number
2652613|NCT01650805|Secondary|<10% BCR-ABL^IS Rate|To compare the proportion of patients achieving a ratio of <10% BCR-ABL to ABL transcript levels at 3 months, as measured by the international scale (<10% BCR-ABL^IS), in patients administered ponatinib versus those administered imatinib|3 months after first dose|Patients with 3 month assessment|||participants|||Number
2652614|NCT01650805|Secondary|MMR Rate|To compare the efficacy of ponatinib with imatinib, as measured by MMR rate, at 5 years|5 years after first dose|||||||
2652615|NCT01650805|Primary|Major Molecular Response (MMR) Rate at 12 Months|A ratio of reverse transcribed transcript of BCR-ABL to ABL ≤ 0.1% on the international scale, measured by real-time quantitative polymerase chain reaction.|12 months after first dose|Patients with 12 month assessment (due to early termination of the study, none of the endpoints could be evaluated as planned).|||participants|||Number
2652616|NCT01650779|Secondary|Percent Change From Baseline in Gastrointestinal (GI) Symptoms (Abdominal Pain, Abdominal Distention, and Bowel Irregularities) at Month 2, 4, and 6|Gastrointestinal symptoms (abdominal pain, abdominal distention, and irregular bowel movements) were to be assessed by a modified version of the Irritable Bowel Syndrome (IBS) Severity Scoring System. The modified IBS Severity Scoring System is a 7-item questionnaire. The severity score calculated by summing the scores of 5 of the 7 questions. Each of the 5 questions were scored on a scale of 0 to 100, leading to a total possible score range of 0 to 500, where higher scores indicate more severe gastrointestinal symptoms. The data for this outcome measure was exploratory and to be collected in individual participant listing only.|Baseline, Month 2, 4, 6|The data for this outcome measure was exploratory and to be collected in individual participant listing only. Analysis of this data was planned only if baseline data was collected on a large number of enrolled participants. This was not the case and therefore interpretation of these results were not possible.||||||
2652617|NCT01650779|Secondary|Percent Change From Baseline in Urine GL-3 at Month 2, 4, and 6|Percent change from baseline = ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. For levels reported as BQL, the LLOQ value was divided by 2 and used in the calculation to estimate values in samples that were BQL. The LLOQ for urine GL-3 was 0.2 mcg/mL. The absolute values were calculated in microgram per millimole (mcg/mmol) of creatinine by dividing GL-3 (mcg/mL) by creatinine (mg/mL) and multiplying by 113.13 (mg/mmol), the molecular weight of creatinine. For levels reported BQL, the absolute values were calculated in microgram per millimole (mcg/mmol) of creatinine by dividing 0.1 (mcg/mL) by creatinine (mg/mL) and multiplying by 133.13 (mg/mmol). This study is exploratory because little is known about the dose-response of these biomarkers to ERT or about the clinical significance of the biomarkers.|Baseline, Month 2, 4, 6|All enrolled participants were included in the analysis. Here, 'n' signifies participants with urine GL-3 assessment at the specified time point.|||percent change||Full Range|Median
2652618|NCT01650779|Secondary|Percent Change From Baseline in Plasma Globotriaosylceramide (GL-3) at Month 2, 4 and 6|Percent change from baseline = ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. For levels reported as BQL, the LLOQ value was divided by 2 and used in the calculation to estimate values in samples that were BQL. The LLOQ for plasma GL-3 was 2.0 microgram per milliliter (mcg/mL). This study is exploratory because little is known about the dose-response of these biomarkers to ERT or about the clinical significance of the biomarkers.|Baseline, Month 2, 4, 6|All enrolled participants were included in the analysis. Here, 'n' signifies participants with plasma GL-3 assessment at the specified time point.|||percent change||Standard Deviation|Mean
2652672|NCT01649856|Secondary|Duration of Overall Survival (OS)|OS was defined as the time from randomization to death from any cause.|Up to approximately 4.25 years|ITT Population.|||months||Full Range|Median
2652619|NCT01650779|Primary|Percent Change From Baseline in Plasma Deacylated Globotriaosylceramide (Lyso-GL-3) at Month 2, 4 and 6|Percent change from baseline = ([post-baseline value minus baseline value] divided by [baseline value]) multiplied by 100. For levels reported as below quantitative limit (BQL), the lower limit of quantitation (LLOQ) value was divided by 2 and used in the calculation to estimate values in samples that were BQL. The LLOQ for plasma lyso-GL-3 was 5.0 nanogram per milliliter (ng/mL). This study is exploratory because little is known about the dose-response of these biomarkers to enzyme replacement therapy (ERT) or about the clinical significance of the biomarkers.|Baseline, Month 2, 4, 6|All enrolled participants were included in the analysis. Here, 'n' signifies participants with plasma Lyso-GL-3 assessment at the specified time point.|||percent change||Standard Deviation|Mean
2652620|NCT01650636|Secondary|Changes in Psychosocial Functioning|Changes in psychosocial functioning measured with the Perceived Stress Scale (PSS), Center for Epidemiologic Studies-Depression (CES-D) scale, and the subscales of the Sickness Impact Profile (SIP) for Recreation and Pastimes, and Social Interaction. Greater scores on the PSS indicate greater perceived stress (range: 0-56) and greater scores on the CES-D indicate greater depressive symptoms (range: 0-60). The SIP is divided into 'Social Interaction' and 'Recreation and Pastimes' subscales (ranges: 0-11 and 0-5, respectively), with greater scores indicating greater impact of sickness in the respective domain. Change scores are expressed and calculated as Follow-Up minus Baseline scores.|baseline and 5 and 9 month post-intervention follow-up|Only CFS Patient's data were analyzed. Partner data was not collected for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2652621|NCT01650636|Secondary|Changes in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory Cytokines|Serum samples were collected to measure the pro-inflammatory:anti-inflammatory cytokine ratio ([IL-1β + IL-6 + TNF-α]:[IL-13 + IL-10]) for neuroimmune function. These values are expressed as ratios. Change values are expressed and calculated as Follow-Up minus Baseline values (using ratio values).|baseline and 5 and 9 months post-intervention follow-up|CFS Patients only were analyzed. (Partner data was not analyzed for this measurement)|||Ratio||Standard Deviation|Mean
2652622|NCT01650636|Secondary|Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines|Serum samples were collected to measure the anti-inflammatory cytokines Interleukin (IL)-4, IL-5 and IL-10 for neuroimmune function. Units of measure are raw concentration expressed picograms per milliliter (pg/mL). Change values are expressed and calculated as Follow-Up minus Baseline values (using raw values).|Baseline, 5 months, 9 months|Only CFS Patients were analyzed. Partner data was not collected for this outcome measure.|||pg/mL||Standard Deviation|Mean
2652623|NCT01650636|Secondary|Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines|Serum samples were collected to measure the pro-inflammatory cytokines Interleukin (IL)-1a, IL-6 and Tumor Necrosis Factor (TNF)-a for neuroimmune function. Units of measure are raw concentration expressed picograms per milliliter (pg/mL). Change values are expressed and calculated as Follow-Up minus Baseline values (using raw values).|Baseline, 5 months, 9 months|CFS Patients Only were analyzed. Data for this outcome measure were not collected from partners.|||pg/mL||Standard Deviation|Mean
2652624|NCT01650636|Secondary|Changes in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol.|Changes in salivary cortisol diurnal pattern is measured to determine changes in neuroimmune function. Salivary cortisol diurnal pattern is computed as the natural log of the average within-day slope of change over the 2-day collection period. This measurement is made at baseline, 5 month follow-up and 9 month follow-up. Outcomes are expressed as change in Cortisol Diurnal Pattern (natural log of average 2-day slope values) and expressed and calculated as Follow-Up minus Baseline values (using the natural log of average 2-day slope values).|baseline and 5 and 9 month post-intervention follow-up|CFS Patients only were analyzed. (Partner data was not analyzed for this measurement)|||Ug/dL||Standard Deviation|Mean
2652625|NCT01650636|Primary|Changes in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms|Changes in the composite product of average frequency and severity scores of CDC-based CFS symptoms assessed by the CDC Symptom Inventory. Participants rated the frequency (1: A little of the time to 5: All of the time) and severity (1: Very mild to 5: Very severe) of individual CFS symptoms. Greater units on the scale indicate greater symptom frequency or severity. The composite outcome measure was calculated as the product of Average Symptom Frequency and Average Symptom Severity. Change scores are expressed and calculated as Follow-Up minus Baseline scores for the composite product score.|baseline and 5 and 9 months post-intervention follow-up|CFS Patients only were analyzed. (Partner data was not analyzed for this measurement)|||Units on a scale||Standard Deviation|Mean
2652626|NCT01650636|Primary|Changes in Frequency and Severity of CDC-based CFS Symptoms|Changes in the average frequency and average severity ratings of CFS symptoms as assessed by the CDC Symptom Inventory. Participants rated the frequency (1: A little of the time to 5: All of the time) and severity (1: Very mild to 5: Very severe) of individual CFS symptoms. Greater units on the scale indicate greater symptom frequency or severity. The outcome measure was calculated as a set of two composite scores: 1) Average Symptom Frequency, reflecting an aggregated average of frequency across all symptoms, and 2) Average Symptom Severity, reflecting an aggregated average of severity across all symptoms. Change scores are expressed and calculated as Follow-Up minus Baseline scores for average symptom frequency and average symptom severity.|baseline and 5 and 9 month post-intervention follow-up|CFS Patients only were analyzed. (Partner data was not analyzed for this measurement)|||Units on a scale||Standard Deviation|Mean
2652627|NCT01650545|Secondary|Overall Survival at 5 Years Follow-up|Number of participants surviving at 5 year follow-up|5 years||||Participants|||Count of Participants
2652628|NCT01650545|Secondary|Cytokine Analysis From BAL Fluid in Lung|Multiple cytokines were assessed as markers of lung inflammation that may be used in addition to biopsy data, collected per patient as clinically indicated during the follow-up interval. Values are reported as mean change from baseline in each group, per week|baseline to approximately 1 year||||pg/mL||95% Confidence Interval|Mean
2652629|NCT01650545|Primary|Number Of Participants With Chronic Rejection Who Met Primary Combined End-point|Treatment failure defined as: BOS progression (> 20% decline lung function), re-transplant, or death|approximately 1 year||||Participants|||Count of Participants
2652630|NCT01650519|Secondary|Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Time to Rescue Medication in the Postoperative Period Through Discharge|Measurement of the amount of time to rescue medication in the postoperative period.|24 hours||||Hours||Standard Deviation|Mean
2652631|NCT01650519|Secondary|Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Pain Intensity as Assess by Patient Pain Intensity (VAS) in the Post-surgical Period, Through 24 Hours|"Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) in the post-surgical period through 24 hours post-procedure. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. Subject's were contacted at 24 hour post-discharge during a follow-up phone contact and asked to completed the VAS at Rest and VAS with Movement and return both completed VAS assessments via the envelope provided. The analysis was performed on the VAS assessments returned to the study site."|24 Hours||||units on a scale||Standard Error|Mean
2652632|NCT01650519|Secondary|Incidence of Serious Adverse Events (SAEs).|Measurement of the incidence of serious adverse events.|24 hours||||Number of Events|||Number
2652633|NCT01650519|Secondary|Patient Satisfaction.|"Measurement of patient satisfaction post-procedure. During the post-treatment period, subjects were asked to complete a satisfaction questionnaire (Quality of Recovery - 40 or QoR-40) defining their quality of recovery at 24 hours following surgery. The QoR - 40 is a 40-item questionnaire that provides a global score and subscores across five dimensions of quality of recovery: emotions (minimum score = 6, maximum score = 30), physical comfort (minimum score = 8, maximum score = 40), patient support (minimum score = 7, maximum score = 35), physical independence (minimum score = 5, maximum score = 25), and pain (minimum score = 7, maximum score = 35). Higher subscores represent a better outcome.~Subscores are added to create a Global QoR-40 score. Global scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)."|24 hours||||units on a scale||Standard Deviation|Mean
2652634|NCT01650519|Secondary|Time to Discharge.|Measurement of the time to discharge in the postoperative period.|24 hours||||Hours||Standard Deviation|Mean
2652635|NCT01650519|Secondary|Measurement of the Efficacy of IV Ibuprofen for the Treatment of Postoperative Pain as Measured by the Amount of Rescue Medication in the Postoperative Period Through Discharge|Measurement of the amount of rescue medication in the postoperative period.|24 hours||||milligrams||Standard Deviation|Mean
2652636|NCT01650519|Primary|Efficacy of IV Ibuprofen for Post-op Pain.|"Measurement of the efficacy of IV ibuprofen for the treatment of postoperative pain as measured by patient pain intensity (Visual Analog Scale, VAS) upon first possible assessment following surgery. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between o and 100."|first possible assessment following surgery||||units on a scale||Standard Deviation|Mean
2652637|NCT01650350|Secondary|To Assess the Toxicity Associated With Low Dose Naltrexone for Melanoma, CRPC and Renal Cancer.|Defined by number of patients who experienced a SAE|3 months||||Participants|||Count of Participants
2652638|NCT01650350|Primary|Number of Responses to Low Dose Naltrexone for Patients With Advanced Melanoma, Castrate Refractory Prostate Cancer (CRPC) or Renal Cancer Via RECIST|Response will be assessed via RECIST 1.1 criteria utilizing interval CT scans and physical exam after every 3 cycles of treatment (i.e. every 12 weeks).|approximately every 3 months CT, every month physical, up to 6 months||||participants|||Number
2652639|NCT01650324|Secondary|Change of Dipeptidyl Peptidase 4 (DPP4) Activities Between 48 Hrs Post Dose and 0 hr Predose|Change of plasma DPP4 activity at 48 hrs post dose from predose (0 hr). The values were computed as areas under the DPP4 activity-time curve using ANCOVA model, in which the unit of the activity is pmol/min.|predose (0 hr) and 48 hrs post dose|All enrolled participants.|||h*pmol/min||Standard Deviation|Geometric Mean
2652640|NCT01650324|Secondary|Profile of Pharmacokinetics - Time of Maximum Plasma Concentration (Tmax)|Plasma samples were used to determine the Time of Maximum Plasma Concentration for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups.|predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose|All participants who received a single dose of DBPR108 25 mg, 100 mg, 300 mg, or 600 mg.|||hrs||Full Range|Median
2652641|NCT01650324|Secondary|Profile of Pharmacokinetics - Observed Maximum Plasma Concentration (Cmax)|Plasma samples were used to determine the Cmax for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups.|predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose|All participants who received a single dose of DBPR108 25 mg, 100 mg, 300 mg, or 600 mg.|||ng/mL||Standard Deviation|Geometric Mean
2652642|NCT01650324|Secondary|Profile of Pharmacokinetics - Area Under the Plasma Concentration-Time Curve (AUC From 0 to Infinity)|Plasma samples were used to determine the AUC from time 0 to infinity for DBPR108. The placebo group is not included in the table below; this outcome measure only evaluated the DBPR108 groups.|predose (0 hr), 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post dose|All participants who received a single dose of DBPR108 25 mg, 100 mg, 300 mg, or 600 mg.|||ng*h/mL||Standard Deviation|Geometric Mean
2652643|NCT01650324|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|There were 4 mild adverse events observed during the course of study.|Adverse events were collected from Day -1 (baseline) through the end of the study, up to Day 7.|All enrolled participants.|||participants|||Number
2652644|NCT01650285|Secondary|Number of Participants Experiencing a Toxicity Associated With Cabazitaxel and Adjuvant Radiation Following Prostatectomy for Patients With Stage 3 Prostate Cancer and for Patients With a PSA Elevation Post-Prostatectomy.|Assess toxicity using CTCAE version 4.0. Number of patients who experienced a toxicity on the study. Not all toxicities are related to study treatment. Of note, there were no serious adverse events on this trial.|During study treatment (approximately 8 weeks) through 30 days post treatment, approximately 12 weeks.||||Participants|||Count of Participants
2652673|NCT01649856|Secondary|Number of Deaths||Up to approximately 4.25 years|ITT Population.|||participants|||Number
2652645|NCT01650285|Primary|Maximum Tolerated Dose of Cabazitaxel With Concurrent Adjuvant Radiation|The MTD was not determined secondary to the study closing early. That being said the numbers provided below show that 4 patients were treated on study to aide in the investigation of the MTD. Only 1 dose was fully evaluated which was 5mg/m2|2 mos|while 5 participants were enrolled only 4 completed treatment as patients # 5 only received part of day 1 therapy secondary to an AE and therefore is not included in the assessment.|||mg/m2|||Number
2652646|NCT01650259|Secondary|Change From Baseline in HbA1c at the Last Observation During the Observation Period.|Change from baseline in Haemoglobin A1c (HbA1c) at the last observation during the observation period is presented as mean change from baseline and standard deviation (SD).|Baseline and 156 week or last observation|Efficacy Set: A subset of the safety set, which includes all patients in the “safety set” except those who had no available efficacy data and/or who did not suffer from type 2 diabetes mellitus from the safety set.|||percentage of HbA1c||Standard Deviation|Mean
2652647|NCT01650259|Primary|Percentage of Participants With Adverse Drug Reactions (ADRs)|"An adverse drug reactions (ADR) was defined as an adverse event (AE) if either the investigator or the sponsor (or both) assessed the causal relationship of Trazenta® Tablets either as Yes, Probably yes or Can't be denied."|From start of the treatment until the end of this PMS, i.e. up to week 156|Safety Set (SS): SS includes all patients who had received treatment of Trazenta® Tablets as mono therapy except those who were found to have no observation after enrolment, invalid registration, or invalid contract.|||Percentage of Participants|||Number
2652648|NCT01650246|Primary|Incidence of Treatment-emergent Adverse Events (TEAEs)||Up to approximately 2 years|Safety Population|||TEAEs|||Number
2652649|NCT01650246|Primary|Proportion of Subjects With a Serum Urate (sUA) Level That is < 6.0 mg/dL||Month 1|Safety Population|||Subjects|||Number
2652650|NCT01650194|Other Pre-specified|Androgen Receptor Signaling Assessed by Expression and Localization of Androgen Receptor (AR), CYP17 Expression, Splice Variants, and Pathways Linked With Non-classical AR Signaling and Bone Development|The endpoint was considered exploratory and no analysis was planned.|Baseline and Week 9|Data for these endpoints were not collected.||||||
2652651|NCT01650194|Secondary|Change From Baseline in Urine N-Telopeptide|Bone metabolism marker urine N-telopeptide levels were derived from urine samples collected.|Baseline and Week 9|The analysis population consisted of the SAF (participants with available data).|||nmolBCE/mmolcreat||Standard Deviation|Geometric Mean
2652652|NCT01650194|Secondary|Change From Baseline to EoT in Bone Specific Alkaline Phosphatase|Bone metabolism marker bone specific alkaline phosphatase levels were derived from blood samples collected.|Baseline and EoT; the median duration of treatment was 10.1 months.|The analysis population consisted of the SAF (participants with available data).|||ug/L||Standard Deviation|Geometric Mean
2652653|NCT01650194|Secondary|Bone Scan Response at EoT|PD: ≥1 of 3 criteria: PSA progression: ≥2 rising PSA levels, interval of ≥1 week between each determination. Soft tissue disease progression: RECIST 1.1. Bone disease progression: PCWG2 criteria (≥2 or new lesions on bone scan compared with prior scan). Target lesion CR: disappearance of all target lesions, PR as ≥30% decrease in sum of longest diameter (LD) of target lesions, referencing baseline sum LD, SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing smallest sum LD since treatment start, PD ≥20% increase in sum of LD of target lesions, referencing smallest sum LD recorded since treatment start or appearance of ≥1 new lesions. Non-target lesions CR: disappearance of all non-target lesions and normalization of tumor marker level, SD: persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits, PD: appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions.|EoT; the median duration of treatment was 10.1 months.|The analysis population consisted of the SAF (participants with available data).|||Participants|||Count of Participants
2652654|NCT01650194|Secondary|Percentage of Participants With Objective Response for Soft Tissue Lesions According to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST)|Objective response was based on RECIST version 1.1 for soft tissue lesion on Magnetic resonance imaging (MRI) / Computerized tomography (CT) and the PCWG2 guidelines for bone lesions on bone scans and was defined as partial response (PR) or complete response (CR) based on the investigators' assessments of target, non-target and new lesions while on study treatment. The 95% for objective response rate was based on exact binomial 95% confidence interval (Clopper-Pearson).|Up to 1849 days|The analysis population consisted of the SAF (participants with measurable soft tissue disease per RECIST 1.1 at baseline with available data).|||percentage of participants||95% Confidence Interval|Median
2652655|NCT01650194|Secondary|Progression Free Survival (PFS)|PFS was measured as the time from the date of first dose of any drug of the study combination treatment until the first evidence of documented progression (a composite endpoint consisting of radiographic progression or PSA progression by PCWG2 or clinical deterioration) or death in the absence of progression (whichever came first) or the date last known to be progression free. The Kaplan-Meier (KM) 95% CI was based on Brookmeyer and Crowley robust non-parametric method.|Up to 1849 days|The analysis population consisted of the SAF.|||days||95% Confidence Interval|Median
2652656|NCT01650194|Secondary|Change From Baseline to End-of-Treatment (EoT) in Prostate-Specific Antigen (PSA) Levels|Prostate-specific antigen progression by Prostate Cancer Clinical Trials Working Group 2 (PCWG2) was defined as a PSA increase ≥25% and ≥2 ng/ml above the post-baseline nadir, and which was confirmed by the first subsequent value of 3 or more weeks later.|Baseline and EoT; the median duration of treatment was 10.1 months.|The analysis population consisted of the SAF (participants with available data).|||ug/L||Standard Deviation|Geometric Mean
2652657|NCT01650194|Secondary|Change From Baseline in Pregnenolone Concentration in Blood|Pregnenolone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry.|Baseline and Week 9|The analysis population consisted of the plasma pregnenolone evaluable set (PEES) which consisted of all participants from the SAF with baseline and week 9 pregnenolone laboratory results derived from plasma samples.|||pg/ml||Standard Deviation|Geometric Mean
2652695|NCT01649791|Secondary|Expression of B-CLL Co-stimulatory Ligands, Mic-A, and Mic-B Assessed by Flow Cytometry|PI left the institute and the data was not collected.|8 days|No participants were analyzed.||||||
2652696|NCT01649791|Secondary|Incidence of Immune Mediated Flare Reaction|Number of participants with Tumour flare.|24 months|All treated and eligible patients.|||participants|||Number
2652658|NCT01650194|Secondary|Change From Baseline in Progesterone Concentration in Blood|Progesterone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry.|Baseline and Week 9|The analysis population consisted of the plasma progesterone evaluable set (POES) which consisted of all participants from the SAF with baseline and week 9 progesterone laboratory results derived from plasma samples.|||nmol/L||Standard Deviation|Geometric Mean
2652659|NCT01650194|Secondary|Change From Baseline in Androstenedione Concentration in Blood|Androstenedione concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry.|Baseline and Week 9|The analysis population consisted of the plasma androstenedione evaluable set (PAOS) which consisted of all participants from the SAF with baseline and week 9 androstenedione laboratory results derived from plasma samples.|||nmol/L||Standard Deviation|Geometric Mean
2652660|NCT01650194|Secondary|Change From Baseline in Cortisol Concentration in Blood|Cortisol concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry.|Baseline and Week 9|The analysis population consisted of the plasma cortisol evaluable set (PCES) which consisted of all participants from the SAF with baseline and week 9 cortisol laboratory results derived from plasma samples.|||nmol/L||Standard Deviation|Geometric Mean
2652661|NCT01650194|Secondary|Change From Baseline in DHT Concentration in Blood|DHT concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. The endpoint could not be analyzed since no participants had DHT levels over the lower limit of quantification (LLOQ).|Baseline and Week 9|The endpoint could not be analyzed since no participants had DHT levels over the LLOQ.||||||
2652662|NCT01650194|Secondary|Change From Baseline in Testosterone Concentration in Blood|Testosterone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry.|Baseline and Week 9|The analysis population consisted of the plasma testosterone evaluable set (PTES) which consisted of all participants from the SAF with baseline and week 9 testosterone laboratory results derived from plasma samples.|||nmol/L||Standard Deviation|Geometric Mean
2652663|NCT01650194|Secondary|Change From Baseline in Pregnenolone in Bone Marrow Aspirate|Pregnenolone in bone marrow aspirate was measured by laboratory results derived from bone marrow samples.|Baseline and Week 9|The analysis population consisted of the biomarker pregnenolone evaluable set (BEES) which consisted of all participants from the SAF with baseline and week 9 pregnenolone laboratory results derived from bone marrow samples.|||pg/ml||Standard Deviation|Geometric Mean
2652664|NCT01650194|Secondary|Change From Baseline in Progesterone in Bone Marrow Aspirate|Progesterone in bone marrow aspirate was measured by laboratory results derived from bone marrow samples.|Baseline and Week 9|The analysis population consisted of the biomarker progesterone evaluable set (BOES) which consisted of all participants from the SAF with baseline and week 9 progesterone laboratory results derived from bone marrow samples.|||nmol/L||Standard Deviation|Geometric Mean
2652665|NCT01650194|Secondary|Change From Baseline in Androstenedione in Bone Marrow Aspirate|Androstenedione in bone marrow aspirate was measured by laboratory results derived from bone marrow samples.|Baseline and Week 9|The analysis population consisted of the biomarker androstenedione evaluable set (BAOS) which consisted of all participants from the SAF with baseline and week 9 androstenedione laboratory results derived from bone marrow samples.|||nmol/L||Standard Deviation|Geometric Mean
2652666|NCT01650194|Secondary|Change From Baseline in Cortisol in Bone Marrow Aspirate|Cortisol in bone marrow aspirate was measured by laboratory results derived from bone marrow samples.|Baseline and Week 9|The analysis population consisted of the biomarker cortisol evaluable set (BCES) which consisted of all participants from the SAF with baseline and week 9 cortisol laboratory results derived from bone marrow samples.|||nmol/L||Standard Deviation|Geometric Mean
2652667|NCT01650194|Secondary|Change From Baseline in Dihydrotestosterone (DHT) Concentration in Bone Marrow Aspirate|DHT concentration in bone marrow aspirate was to be measured by laboratory results derived from bone marrow samples processed through liquid chromatography mass spectrometry. DHT bone data were not collected.|Baseline and Week 9|DHT bone data were not collected.||||||
2652668|NCT01650194|Secondary|Change From Baseline in Testosterone Concentration in Bone Marrow Aspirate|Testosterone concentration in bone marrow aspirate was measured by laboratory results derived from bone marrow samples processed through liquid chromatography mass spectrometry.|Baseline and Week 9|The analysis population consisted of the biomarker testosterone evaluable set (BTES) which consisted of all participants from the SAF with baseline and week 9 testosterone laboratory results derived from bone marrow samples.|||pmol/L||Standard Deviation|Geometric Mean
2652669|NCT01650194|Primary|Number of Participants With Adverse Events (AEs)|A treatment-emergent adverse event (TEAE) was defined as an adverse event occurring or worsening between the start of study treatment date and the latest date of 30 days after the last dose date or the 30-day follow-up visit date, and not later than the data cut-off date or the date of death. AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) guidelines (V4.03).|From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.|The analysis population consisted of the safety analysis set (SAF) which consisted of all participants who received at least 1 dose of any drug of the study combination treatment (i.e., enzalutamide, abiraterone and prednisone).|||Participants|||Count of Participants
2652670|NCT01649947|Secondary|Progression Free Survival (PFS)|Kaplan-Meier estimates of survival were calculated. The median survival times and 95% confidence intervals are presented.|6 years|Median PFS (in months) were calculated|||months||95% Confidence Interval|Median
2652671|NCT01649947|Primary|Antitumor Activity, as Measured by Tumor Response Rate of Hydroxychloroquine, Paclitaxel, Carboplatin, and Bevacizumab (for Eligible Patients) in Patients With Advanced or Recurrent NSCLC Cancer|Assessed using RECIST criteria. Determined using a Simon's two-stage minimax design with a 5% significance level and 80% power.|6 years|The analysis is comprise of evaluable patients who had measurable disease and received at least one cycle of therapy and had disease evaluated.|||percentage of participants||95% Confidence Interval|Number
2652674|NCT01649856|Secondary|Duration of Progression-Free Survival (PFS)|PFS was defined as the time from randomization to first occurrence of disease progression, relapse, or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.|Up to approximately 4.25 years|ITT Population.|||months||Full Range|Median
2652675|NCT01649856|Secondary|Number of Participants With Progression, Relapse, or Death|Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.|Up to approximately 4.25 years|ITT Population.|||participants|||Number
2652676|NCT01649856|Secondary|Duration of Disease-Free Survival (DFS)|DFS was defined as the time from date of initial CR/CRu to the date of relapse or death from any cause. Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.|Up to approximately 4.25 years|ITT Population (Responder Subpopulation).|||months||Full Range|Median
2652677|NCT01649856|Secondary|Number of Participants With Relapse or Death at the Time of Primary Analysis|Tumor response was assessed according to criteria published by Cheson et al (1999). Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu. The number of participants who had experienced relapse or death prior to the clinical cut-off date (October 2014) was determined.|Up to approximately 2 years (assessed at Baseline, Day 1 of each cycle [maximum 8 cycles; each cycle was 14 or 21 days], every 3 months thereafter, and/or 4 weeks after early termination)|ITT Population (Responder Subpopulation): All participants who achieved CR or CRu after 4 cycles.|||participants|||Number
2652678|NCT01649856|Secondary|Duration of EFS|EFS was defined as the time from randomization to first occurrence of disease progression, relapse, initiation of other anti-lymphoma therapy, or death, whichever occurred first. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as a ≥50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.|Up to approximately 4.25 years|ITT Population.|||months||Full Range|Median
2652679|NCT01649856|Secondary|Number of Participants With an Event-Free Survival (EFS) Event|EFS events included disease progression, relapse, initiation of other anti-lymphoma therapy, or death. Tumor response was assessed according to criteria published by Cheson et al (1999). Progression was defined as greater than or equal to (≥) 50% increase in the sum of products of greatest diameters of any previously identified abnormal lymph node or the appearance of any new lesion. Relapse was defined as a new lesion or increase by ≥50% in size of previously involved sites, or ≥50% increase in greatest diameter of any previously identified node >1 cm, following an earlier assessment of CR or CRu.|Up to approximately 4.25 years|ITT Population.|||participants|||Number
2652680|NCT01649856|Secondary|Percentage of Participants by Time Spent in the Hospital for Each Treatment Cycle|"Hospital time was defined as the amount of time the participant was in the hospital for the course of one cycle of rituximab + CHOP chemotherapy. Where the hospital time was not documented for a given cycle, it was reported as Missing."|Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)|Safety Population.|||percentage of participants|||Number
2652681|NCT01649856|Secondary|Percentage of Participants by Time Spent in the Infusion Chair/Bed for Each Treatment Cycle|"Chair time was defined as the amount of time the participant occupied an infusion chair/bed for a single treatment cycle of rituximab + CHOP chemotherapy. Where the chair time was not documented for a given cycle, it was reported as Missing."|Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)|Safety Population.|||percentage of participants|||Number
2652682|NCT01649856|Secondary|Median Duration of Rituximab Administration for Each Treatment Cycle|Duration of rituximab administration was defined as the time from start to end of the SC injection or IV infusion. The median duration was reported.|Cycles 1, 2, 3, 4, 5, 6, 7, and 8 (each cycle was 14 or 21 days)|Safety Population; n = number of participants in the analysis for the specified timepoint.|||hours||Full Range|Median
2652683|NCT01649856|Secondary|Rituximab Administration Satisfaction Questionnaire (RASQ) Domain Scores|The RASQ is a 20-item questionnaire that measures five domains related to the impact of treatment administration. These include physical impact, psychological impact, impact on activities of daily living (ADLs), convenience, and satisfaction. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.|At Cycle 7 (each cycle was 14 or 21 days)|ITT Population (RASQ Subpopulation): All participants who completed the RASQ at Cycles 3 and 7; n = number of participants in the analysis for the specified domain.|||units on a scale||Standard Deviation|Mean
2652684|NCT01649856|Secondary|Cancer Treatment Satisfaction Questionnaire (CTSQ) Domain Scores|The CTSQ is a validated 16-item questionnaire that measures three domains related to satisfaction with cancer therapy. These include expectations of therapy, feelings about side effects, and satisfaction with therapy. Each domain is scored on a scale of 0 to 100, with higher scores indicative of more positive feelings toward therapy. The score for each domain was averaged among all participants.|At Cycle 7 (each cycle was 14 or 21 days)|ITT Population (CTSQ Subpopulation): All participants who completed the CTSQ at Cycles 3 and 7; number (n) = number of participants in the analysis for the specified domain.|||units on a scale||Standard Deviation|Mean
2652697|NCT01649791|Secondary|Overall Response Rate (CR+PR)||24 months|All treated and eligible patients.|||percentage of participants|||Number
2652698|NCT01649791|Primary|Median Progression-free Survival||24 months|All treated and eligible patients.|||months||95% Confidence Interval|Median
2652685|NCT01649856|Primary|Percentage of Participants With Complete Response (CR) or Complete Response Unconfirmed (CRu)|Tumor response was assessed per criteria published by Cheson et al (1999). According to consensus recommendations, CR was defined as complete disappearance of all clinical and radiographic evidence of disease and disease-related symptoms, regression of lymph nodes to normal size, absence of splenomegaly, and absence of bone marrow involvement. CRu was defined as disappearance of clinical and radiographic evidence of disease and absence of splenomegaly, with regression of lymph nodes by greater than (>) 75 percent (%) but still >1.5 centimeters (cm) in size, and indeterminate bone marrow assessment. The percentage of participants with either response at the end of induction (EOI) was determined with corresponding 95% Pearson-Clopper confidence interval (CI).|Up to approximately 4.25 years|Intent-to-Treat (ITT) Population: All participants who completed Baseline and at least one on-treatment efficacy assessment.|||percentage of participants||95% Confidence Interval|Number
2652686|NCT01649804|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI)|The Health Assessment Questionnaire Disability Index (HAQ-DI) is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible scores range from 0 to 3, where 0=least difficulty, and 3=extreme difficulty.|End of Study (Week 104 or early withdrawal)|Analysis population included all the enrolled participants in the study.|||units on a scale||Standard Deviation|Mean
2652687|NCT01649804|Secondary|Number of Participants With Decreased, Unchanged, and Increased Participant Global Assessment of Pain|"A participant's overall assessment of pain on a VAS was assessed with a question concerning the amount of pain due to arthritis. Pain was assessed on a 100 mm VAS scale with a left-hand marker no pain (0 mm) or right-hand marker extreme pain (100 mm)."|Week 12 and Week 104|"Analysis population included all the evaluable participants for this outcome measure. n included all the participants analyzed on that particular time point."|||participants|||Number
2652688|NCT01649804|Secondary|Number of Participants With Decreased, Unchanged, and Increased Participants Global Assessment of Disease Activity|The participant global assessment of disease activity was measured using a 100 mm VAS ranging from 0=very good to 100=very bad.|Week 12 and Week 104|"Analysis population included all the evaluable participants for this outcome measure. n included all the participants analyzed on that particular time point."|||participants|||Number
2652689|NCT01649804|Secondary|Time to Rheumatoid Arthritis (RA) Flare|RA flare was defined as any worsening of the participant's disease activity that in the opinion of the Investigator required treatment intensification beyond supportive therapy which included restarting of the study drug treatment. Time to RA flare was defined as the period of drug-free remission until documentation of RA flare. Drug-free remission was defined as clinical remission (based on DAS28-ESR < 2.6 and /or SDAI ≤ 3.3) for two consecutive assessment visits, followed by discontinuation of tocilizumab, at the Investigator's discretion, at the second assessment visit.|End of Study (Week 104 or early withdrawal)|This outcome could not be evaluated as there were no participants who had achieved drug-free remission, per protocol definition.||||||
2652690|NCT01649804|Secondary|Number of Participants With Decreased, Unchanged, and Increased Swollen Joint Count (SJC)|Swollen joint count was performed by a skilled assessor, evaluating 66 joints for swelling.|Week 12 and Week 104|"Analysis population included all the evaluable participants for this outcome measure. n included all the participants analyzed on that particular time point."|||participants|||Number
2652691|NCT01649804|Secondary|Number of Participants With Decreased, Unchanged, and Increased Tender Joint Count (TJC)|Tender joint count was performed by a skilled assessor, evaluating 68 joints for tenderness.|Week 12 and Week 104|"Analysis population included all the evaluable participants for this outcome measure. n included all the participants analyzed on that particular time point."|||participants|||Number
2652692|NCT01649804|Secondary|Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Simplified Disease Activity Index (SDAI)|The SDAI was defined as the numerical sum of 5 outcome parameters: tender and swollen joint count (based on a 28-joint assessment), participant and physician global assessment of disease activity on a 100 millimeter (mm) Visual analogue scale (VAS) (VAS; 0 = no disease activity and 100 = worst disease activity) and level of C-reactive protein (CRP) (milligram per deciliter [mg/dl], normal < 1 mg/dl). SDAI total score = 0-86 where a higher score reflects worsening disease. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.|Screening and End of Study (Week 104 or early withdrawal)|Analysis population included all the enrolled participants in the study.|||participants|||Number
2652693|NCT01649804|Secondary|Number of Participants With Remission, Low, Medium, and High Disease Activity, as Measured by Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR)|The DAS28 (ESR) score is a measure of the participant's disease activity. It is calculated using the tender joint count (28 joints), swollen joint count (28 joints), erythrocyte sedimentation rate (ESR) and general health status. The DAS28-ESR scale ranges from 0 to 10, where higher scores represent higher disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity, DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Screening and End of Study (Week 104 or early withdrawal)|Analysis population included all the enrolled participants in the study.|||participants|||Number
2652694|NCT01649804|Primary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. Adverse Events of Special Interest for this study were: Serious and/or medically significant infections; myocardial infarction/Acute coronary syndrome; Gastrointestinal perforation; Malignancies; Anaphylaxis/hypersensitivity reactions; Demyelinating disorders; Stroke and Serious and/or medically significant bleeding and hepatic events.|End of Study (Week 104 or early withdrawal)|Analysis population included all the enrolled participants in the study.|||percentage of participants|||Number
2652700|NCT01649765|Secondary|Maximum Concentration at Steady State (Cmax, ss) and Minimum Concentration at Steady State (Cmin, ss)|The pharmacokinetic (PK) population comprised all participants included in the As- Treated population for whom at least one post belimumab treatment PK sample was obtained and analyzed. The PK model was fitted to the observed serum concentration-time data. The maximum (Cmax) and minimum (Cmin) concentrations reported in this table are model derived values at ss, assuming a 10 mg/kg dose administered once every 28 days.|28-days dosing interval at steady state|PK Population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2652701|NCT01649765|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported.|Up to 60 weeks|Intent-to-Treat Population|||Participants|||Count of Participants
2652702|NCT01649765|Secondary|Percentage of Participants With a Sustained ParentGA Response|Sustained ParentGA response was defined as having >0.7 improvement at Weeks 44, 48, and 52 compared at Baseline. Data for percentage of participants with a sustained ParentGA response was presented. Thirteen participants had a score of <=0.7 at Baseline and therefore, could not be included in the analysis.|Up to 52 weeks|Intent-to-Treat Population|||Percentage of Participants|||Number
2652703|NCT01649765|Secondary|Percentage of Participants With a Sustained SRI Response|Sustained SRI response was defined as having a response on the primary efficacy endpoint at Weeks 44, 48, and 52. Data for percentage of participants with a sustained SRI response was presented. Drop Outs and Treatment Failures were considered Non-Responders. Only those participants with data available at specific time point were analyzed.|Up to 52 weeks|Intent-to-Treat Population|||Percentage of participants|||Number
2652704|NCT01649765|Secondary|Percent Change From Baseline in Proteinuria at Week 52|Percent change from Baseline in proteinuria was calculated. The percent change from baseline to Week 52 in 24 hour proteinuria was analyzed using summary statistics and 95% confidence intervals, without any adjustment for covariates. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline Value X 100. LOCF was used.|Baseline (Day 0) and Week 52|Intent-to-Treat Population|||Percent Change||Full Range|Median
2652705|NCT01649765|Secondary|Percent Change From Baseline in PedsQL Physical Functioning Domain Score at Week 52|The PedsQL is a generic quality of life scale validated for the pediatric population which consists of 23 items, encompassing 4 health domains: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). From the raw scores of the 23 items, a total summary score and individual domain scores can be calculated. The total and domain scores are each transformed on a 0 to 100 score with higher scores indicating higher quality of life. For Physical Functioning Domain scale, score was from 0 to 100 where, 0 indicates lower quality of life and 100 indicates greater quality of life. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline Value X 100. LOCF was used.|Baseline (Day 0) and Week 52|Intent-to-Treat Population|||Percent change||Full Range|Median
2652706|NCT01649765|Secondary|Percent Change From Baseline in SELENA SLEDAI at Week 52|The SELENA SLEDAI score is a weighted index for assessing SLE disease activity in which signs and symptoms, laboratory tests and physician's assessment for each of 9 organ system were given a weighted score and summed if present at the time of the visit or in the preceding 10 days. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. A decrease of 4 points or more equates to a clinically meaningful improvement. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100. One participant had missing data at Baseline and therefore, could not be included in the analysis.|Baseline (Day 0) and Week 52|Intent-to-Treat Population|||Percent change||Standard Deviation|Mean
2652707|NCT01649765|Secondary|Percent Change From Baseline in PGA at Week 52|The PGA is a 10 centimeter (cm) visual analogue scale (VAS), anchored at 0 (none) and 3 (severe), designed for the physician to indicate the participant's overall disease activity at a particular visit as part of the validated SELENA SLEDAI index. Primary investigator or a subinvestigator scored the PGA for the participant, and same person evaluated the participant each time. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100. LOCF was used.|Baseline (Day 0) and Week 52|Intent-to-Treat Population|||Percent change||Standard Deviation|Mean
2652708|NCT01649765|Secondary|Percent Change From Baseline in ParentGA at Week 52|ParentGA assesses the participant's overall well-being at the moment rated on a 21-numbered circle visual analog scale (VAS; 0 - very well, 10 - very poorly). Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100. Last Observation Carried Forward (LOCF) was used. Eight participants had a score of zero at Baseline and therefore, could not be included in the analysis.|Baseline (Day 0) and Week 52|Intent-to-Treat Population|||Percent change||Full Range|Median
2652719|NCT01649557|Secondary|Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score.|The efficacy of study medication was rated for each participant using the CGI-I. The investigator rated the participants total improvement whether or not it was due to the drug treatment. All responses were compared to the participants condition at Screening/Baseline (i.e, Week 6 visit of Protocol NCT00905307). Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.|||Units on a scale||Standard Deviation|Mean
2659952|NCT01585441|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at the Safety Visit Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Final Study Visit||||decibels|Participants|Standard Deviation|Mean
2652709|NCT01649765|Secondary|Percentage of Participants Meeting Pediatric Rheumatology International Trials Organization (PRINTO)/ American College of Rheumatology (ACR) Juvenile SLE Response Evaluation Criteria for Improvement in Juvenile SLE at Week 52 Using Definition 1 and 2|Percentage of participants meeting PRINTO/ACR Juvenile SLE Response Evaluation criteria for improvement in juvenile SLE using two different PRINTO/ACR Juvenile SLE Response Evaluation definitions of improvement that is Definition 1: At least 50% improvement in any 2 of 5 endpoints below and no more than 1 of the remaining worsening by more than 30% and Definition 2: At least 30% improvement in 3 of 5 endpoints below and no more than 1 of the remaining worsening more than 30%. Endpoints were: 1. Percent change in Parent's Global Assessment (ParentGA) at Week 52, 2. Percent change in PGA at Week 52, 3. Percent change in SELENA SLEDAI score at Week 52, 4. Percent change in Pediatric Quality of Life Inventory (PedsQL) physical functioning domain at Week 52, 5. Percent change in 24 hour proteinuria at Week 52 (gram/24hour equivalent by spot urine protein to creatinine ratio).|Week 52|Intent-to-Treat Population|||Percentage of participants|||Number
2652710|NCT01649765|Primary|Percentage of Participants With SLE Responder Index (SRI) Response at Week 52|SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of <0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (<=12 vs. >=13). Percentage of participants with SRI response at Week 52 of Part A were reported. Intent-to-Treat Population comprised of all participants who were randomized and treated with at least one dose of study agent in Part A. One participant had missing data at Baseline and therefore, could not be included in the analysis.|Week 52|Intent-to-Treat Population|||Percentage of participants|||Number
2652711|NCT01649609|Secondary|Number of Participants With Incidence of BK Nephropathy|The number of people with incidence of BK Nephropathy in each of the two Arms|Up to 24 months from randomization||||Participants|||Count of Participants
2652712|NCT01649609|Primary|Number of Participants With BK Viral Load <600 Copies/mL|A Viral load of <600 copies/mL for at least 3 months indicates sustained clearance of BK viremia, confirmed by blood test|Up to 12 months from enrollment||||Participants|||Count of Participants
2652713|NCT01649596|Secondary|Patient Satisfaction|Secondary outcome is the relative change (%) in patient satisfaction score from pre-op to recovery. Pre-procedure and Post-procedure surveys were given to the participants to complete. Pre-procedure survey contained 9 questions and the post-procedure survey contained 6 questions. The questions were related to comfort, anxiety and satisfaction. A questionnaire was designed with 6 questions (2 pt and 4 pt Likert sub scales) combined. The overall scores were additive and ranged from 5 to 18 points (5 indicating the least anxiety and 18 indicating the highest anxiety). Individual scores were summed, averaged and group averages compared. The relative change in the percent of participants satisfied (somewhat & highly) was calculated for each group. The change in percent satisfied was calculated for each group and compared.|12 hours|All patients completed the patient anxiety and satisfaction survey.|||change in percent satisfied|||Number
2652714|NCT01649596|Primary|Incidence of Hypothermic Events|The primary outcome is the incidence of hypothermic events (core <36 degrees celsius).|12 hours||||participants|||Number
2652715|NCT01649557|Secondary|Percentage of Participants Who Discontinued Due to Lack of Efficacy.|Discontinuation rate for the participants discontinued due to lack of efficacy were examined.|Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.|||Percentage of participants.|||Number
2652716|NCT01649557|Secondary|Percentage of Participants With a Positive Response Rate.|Response rate was defined as a reduction of ≥ 30% from Baseline in PANSS total score or CGI-I score of 1 (very much improved) or 2 (much improved) at the Last Visit.|Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.|||Percentage of participants|||Number
2652717|NCT01649557|Secondary|Change From Baseline in PANSS Negative Subscale Score.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In negative subscale the severity was rated for the following 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative symptom score ranges from 7-49, with higher scores indicating more severe symptoms.|Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.|||Units on a scale||Standard Deviation|Mean
2652718|NCT01649557|Secondary|Change From Baseline in PANSS Positive Subscale Score.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive symptom score ranges from 7-49, with higher scores indicating more severe symptoms.|Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.|||Units on a scale||Standard Deviation|Mean
2652732|NCT01649427|Secondary|ANCOVA Model for Change in CKD-EPI GFR (Chronic Kidney Disease Epidemiology Collaboration Glomerular Filtration Rate) at Month 6 Post-transplantation|ANCOVA model for change in CKD-EPI Glomerular Filtration Rate (GFR)[ml/min] without replacement of missing values|baseline to Month 6|The Full Analysis Set (FAS) consisted of all patients in whom study treatment was assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||mL/min||Standard Error|Least Squares Mean
2652720|NCT01649557|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) Total Score.|The PSP was a validated clinician-rated scale that measured personal and social functioning in four domains: socially useful activities (e.g, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment that determined the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Baseline, Week 1, 2, 6, 26, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.|||Units on a scale||Full Range|Median
2652721|NCT01649557|Secondary|Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score.|"The severity of illness for each participant were rated using the CGI-S. To perform this assessment, the investigator were to answer the following question: Considering your total clinical experience with this particular population, how mentally ill was the participant at that time? Response choices include: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.|||Units on a scale||Standard Deviation|Mean
2652722|NCT01649557|Secondary|Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit.|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more severe symptoms.|Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit|The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.|||Units on a scale||Standard Deviation|Mean
2652723|NCT01649557|Primary|Number of Participants With AEs in 52-Week Enrollers.|AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A SAE was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A TEAE was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.|From Baseline up to 52 weeks|Those participants who received at least one dose of open-label brexpiprazole and who were enrolled in the 52-week study.|||Participants|||Number
2652724|NCT01649557|Primary|Number of Participants With Adverse Events (AEs) During First 6 Weeks.|AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.|From Baseline up to 6 weeks|The safety dataset comprised of those participants who received at least one dose of open-label brexpiprazole and were enrolled in the 6-week study.|||Participants|||Number
2652725|NCT01649505|Secondary|Serious and Nonserious Adverse Events and Complications||Up to day 180 post-operation|||||||
2652726|NCT01649505|Secondary|Quantity of Post-operative Drainage|Defined as total volume of drainage recorded (in ml) by nurses while the patient is in the hospital and by patient himself/herself when discharged home, until the removal of the drain by a doctor once it reaches less than 50 ml per day. Wilcoxon rank sum test will be used to compare the drainage volume of the two groups.|Up to day 10 post-operation|||||||
2652727|NCT01649505|Secondary|Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications|Computed with 95% confidence interval using exact method. Two-sided Fisher's exact test will be used to evaluate whether the wound complication rate are significantly different for the two treatment groups, and the odds ratio with 95% confidence interval will be computed.|Up to day 180 post-operation|||||||
2652728|NCT01649505|Primary|Proportion of Patients in Each Arm Who Develop Post-operative Seromas|Computed with 95% confidence interval using exact method. The difference of seroma rate in the two groups will be computed with 95% confidence interval using exact method. Two-sided Fisher's exact test will be used to evaluate whether the seroma rate are significantly different for the two treatment groups.|Up to day 180 post-operation|||||||
2652729|NCT01649427|Secondary|ANCOVA Model for Change in Cockcroft-Gault GFR (ml/Min) at Month 6, Without Replacement of Missing Values|change in Cockcroft-Gault GFR|least square (LS) mean change from baseline to Month 6||||(ml/min)||95% Confidence Interval|Least Squares Mean
2652730|NCT01649427|Secondary|ANCOVA Model for Change in MDRD GFR (ml/Min) at Month 6, Without Replacement of Missing Values|MDRD GFR|least square (LS) mean change from baseline to Month 6||||(ml/min)||95% Confidence Interval|Least Squares Mean
2652731|NCT01649427|Primary|ANOVA for Dose-normalized Tacrolimus 12-h-AUC (h/103*L) at Month 1|Compares the PK of Tacrolimus Hexal® assessed by the ratio of the AUC0-12h over one month period post transplantation vs. Prograf® in renal transplant patients|end of month 1||||h/10^3*L||90% Confidence Interval|Least Squares Mean
2652745|NCT01649362|Primary|Length of Transition Period|transition period was defined as the period from the introduction of enteral feeding to full enteral feeding|participants were followed from date of randomization until full enteral feeding was acquired,an expected average of 5 weeks||||days||Standard Deviation|Mean
2652733|NCT01649427|Secondary|The Incidence of Biopsy-proven Acute Rejection (BPAR), Graft Loss and Death Until Month 12 (Full Analysis Set) (Full Analysis Set)|The key secondary objective was to assess the incidence of individual endpoints BPAR, graft loss and death until month 6 post-transplantation.|baseline to month 12|The Full Analysis Set (FAS) consisted of all patients in whom study treatment was assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||Incidences||95% Confidence Interval|Number
2652734|NCT01649427|Primary|ANCOVA Model for Change in Nankivell GFR (mL/Min) at Month 6, Without Replacement of Missing Values (Full Analysis Set)|"Change in Nankivell glomerular filtration rate (GFR) from baseline to 6 months~Glomerular Filtration Rate (GFR): The GFR is the best clinical estimate of renal function in health and disease, and correlates well with the clinical severity of renal function disturbances. Several studies have shown that in patients with progressive renal disease, GFR declines or reciprocal serum creatinine levels elevate linearly over time in a predictable manner. With the help of the serum creatinine values, the GFR was calculated via Nankivell formula."|baseline to month 6|The Full Analysis Set (FAS) consisted of all patients in whom study treatment was assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization|||mL/min||95% Confidence Interval|Least Squares Mean
2652735|NCT01649375|Secondary|Percentage of Participants Achieving ASAS Partial Remission at Week 16|ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale 0 to 10. In this study ASAS partial remission is used to assess the efficacy of at least one dose of secukinumab versus placebo.|Baseline up to 16 weeks||||percentage of participants|||Number
2652736|NCT01649375|Secondary|Change From Baseline at Week 16 in ASQoL|ASQoL is an 18 item questionnaire that assesses disease-specific quality of life (QoL), consisting of statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). In this study, ASQoL is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.|Baseline up to 16 weeks||||scores on a scale||Standard Error|Least Squares Mean
2652737|NCT01649375|Secondary|Change From Baseline at Week 16 in Physical Function Component Summary (PCS) of the Medical Outcomes Study Questionnaire Short-form Health Survey (SF-36)|Physical Function Component Summary (PCS) is only 1 component of SF-36. This scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Baseline up to 16 weeks||||scores on a scale||Standard Error|Least Squares Mean
2652738|NCT01649375|Secondary|Change From Baseline at Week 16 for Total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|"BASDAI is a validated assessment tool using 1 through 10 scales (1 indicating no problem and 10 indicating  worst problem), to characterize six clinical domains (fatigue, spinal pain, joint pain/selling, localized tenderness, morning stiffness duration, morning stiffness severity) pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI is used to assess the efficacy of at least one dose of secukinumab verus placebo."|Baseline up to 16 weeks||||scores on a scale||Standard Error|Least Squares Mean
2652739|NCT01649375|Secondary|Percentage of Participants Achieving ASAS 5/6 (SpondyloArthritis International Society Criteria) Response at Week 16|ASAS 5/6 response is a validated composite assessment, reflecting the percentage of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevant to AS (pain, patient global assessment, function, inflammation, spinal mobility, C-reative protein) without deterioration in the 6th domain. In this study, ASAS 5/6 is used to assess the efficacy of at least one dose of secukinumab against placebo.|Baseline up to 16 weeks||||percentage of participants|||Number
2652740|NCT01649375|Secondary|Change From Baseline at Week 16 in Serum hsCRP|The change from baseline in hsCRP is expressed as a ratio of post-baseline to baseline values. With the ratio normalized to 1.0 at baseline, ratios less than 1.0 represent decreased post-baseline values, whereas ratios greater than 1.0 represent increased post-baseline values. Blood levels of C-reactive protein (CRP), an acute phase reactant, are indicative of inflammation and of its severity, and can be used to monitor treatment response. A high sensitvity CRP (hsCRP) test is implemented in this study to assess the efficacy of at least one dose of secukinumab versus placebo in reducing AS elicited systemic inflammation over time.|Baseline up to 16 weeks||||mg/L||Standard Error|Least Squares Mean
2652741|NCT01649375|Secondary|Percentage of Participants Achieving ASAS 40 (SpondyloArthritis International Society Criteria) Response|"ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe an improvement of ≥40% and ≥2 units on a scale of 0 to 10 (0 being worse and 10 being better) in at least three of the four ASAS main domains (patient global, pain, function and inflammation) and no worsening at all in the remaining domain.~ASAS 40 is used to assess the efficacy of at least one dose of secukinumab against placebo."|Baseline up to 16 weeks||||percentage of participants|||Number
2652742|NCT01649375|Primary|Percentage of Participants Achieving ASAS 20 (SpondyloArthritis International Society Criteria) Response at Week 16|ASAS 20 response is a validated composite assessment reflecting the percentage of treated patients who achieve within a defined timeframe an improvement of 20% and ≥1 unit on a scale of 1 to 10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit in the remaining domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.|Baseline up to 16 weeks||||percentage of participants|||Number
2652743|NCT01649362|Secondary|Breastfeeding Rate at Discharge||hospital discharge, an expected average of 5 weeks from the beginning of oral feeding introduction||||participants|||Number
2652744|NCT01649362|Secondary|Length of Hospital Stay||participants were followed for the duration of hospital stay, an expected average of 5 weeks||||days||Standard Deviation|Mean
2657187|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 22|Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 22||||units on a scale||Standard Deviation|Mean
2652746|NCT01649297|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline at Week 16|"Change from baseline in FPG (mg/dL) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.~Means provided are the adjusted means."|Baseline and 16 weeks|FAS with LOCF has been used for FPG analyses|||mg/dL||Standard Error|Mean
2652747|NCT01649297|Primary|HbA1c (Glycosylated Haemoglobin) Change From Baseline at Week 16|"Change from baseline in HbA1c (%) after 16 weeks of treatment. The term 'baseline' refers to the last observation prior to the first intake of any randomised study medication.~Means provided are the adjusted means."|Baseline and 16 weeks|"Full Analysis Set (FAS) is the basis for the intention-to-treat analysis. FAS with last observation carried forward (LOCF) imputation is used as the primary method of accounting for missing data.~Values after the patient started rescue medication were excluded from analysis (and imputed with an LOCF procedure)."|||percentage of HbA1c||Standard Error|Mean
2652748|NCT01649271|Secondary|Clinical Benefit|"Clinical benefit was defined as best overall response of CR or PR or stable disease (SD) where best overall response is defined according to RECIST version 1.1 from first treatment administration until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anti-cancer therapy.~As Per RECIST v1.1 for target lesions (TL) & assessed by MRI: CR: Disappearance of all TL,all non-TL, & no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least 30% decrease in sum of the longest diameter (SLD) of TL taking as reference the baseline SLD. SD: Neither sufficient shrinkage to qualify for PR, taking as reference the baseline SLD, nor sufficient increase to qualify for PD."|Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 33 months|Treated set|||percentage of participants|||Number
2652749|NCT01649271|Secondary|Objective Response|Objective Response (OR) was defined as best overall response of complete response (CR) or partial response (PR), where best overall response was determined according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 from first administration of study medication until the earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anti-cancer therapy. As Per RECIST v1.1 for target lesions (TL) & assessed by MRI: CR: Disappearance of all TL,all non-TL, & no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least 30% decrease in sum of the longest diameter (SLD) of TL taking as reference the baseline SLD.|Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until EOT; up to 33 months|Treated set|||percentage of participants|||Number
2652750|NCT01649271|Secondary|Best Overall Response (BOR)|BOR represents the best response a patient had during their time in study from start of treatment until progression, the last evaluable assessment in absence of progression or start of subsequent anticancer therapy. For patients that died, BOR was to be calculated based on data up to last evaluable RECIST,v1.1 assessment prior to death. Death did not contribute as PD for BOR. As per RECIST v1.1 for target lesions (TL) & assessed by MRI: CR: Disappearance of all TL,all non-TL, & no new lesion. Any pathological lymph nodes must have had reduction in the short axis to <10 mm. PR: At least 30% decrease in sum of the longest diameter (SLD) of TL taking as reference the baseline SLD. PD: At least a 20% increase in SLD of TL taking as reference the smallest SLD recorded since treatment started, together with an absolute increase in SLD of at least 5mm. SD: Neither sufficient shrinkage to qualify for PR, taking as reference the baseline SLD, nor sufficient increase to qualify for PD.|Post baseline tumour-imaging was performed at every 6 weeks (in the week preceding the start of Cycles 3, 5, 7, 9, 11, etc.) until End of Treatment (EOT); up to 33 months|"Treated set~Missing: First image time point not reached before discontinuation."|||percentage of participants|||Number
2652751|NCT01649271|Primary|Dose Limiting Toxicities During cycle1|"Number of Patients With Dose Limiting Toxicity (DLT) occurring during Cycle 1 based on the investigator assessment.~One patient in the Afa30+Trast8 cohort developed tumour lysis syndrome during the first course of treatment and was therefore not evaluable for the primary endpoint."|First 21-day treatment cycle|Treated set|||Participants|||Count of Participants
2652752|NCT01649271|Primary|MTD of Afatinib in Combination With Trastuzumab Based on the Number of Patients With DLTs During the First Treatment Cycle (Afatinib).|"Maximum Tolerated Dose (MTD) of Afatinib in combination with trastuzumab based on the number of patients with dose limiting toxicity (DLT) during the first treatment cycle (Dose escalation part). The MTD was defined as the highest dose studied at which the incidence of a DLT was less than 17% (i.e. 1/6 patients) during the first cycle.~One patient in the Afa30+Trast8 cohort developed tumour lysis syndrome during the first course of treatment and was therefore not evaluable for the primary endpoint."|First 21 days treatment cycle|Treated set: This analysis set includes all patients who were documented to have taken at least one dose of study medication.|||mg|||Number
2652753|NCT01649232|Secondary|Number of Omission and Commission Errors of Behavior Task|After VCPT task, errors by Omission (lack of response in test GO) and by commission (lack of suppression in NOGO and NOVELTY test) were automatically counted for each subject.|From September to December 2012|The number of participants needed for study completion is between 20 and 40 for pilot study if it is homogeneous in patients with clinical signs and symptoms, to test efficacy and safety of noninvasive Brain Stimulation.|||Number of omission and commision errors||Standard Deviation|Mean
2652754|NCT01649232|Secondary|Reaction Time (Behavior Task)|"All subjects performed a Visual continuous performance task (VCPT) with GO/NOGO paradigm. It consists of three types of stimuli: 1) twenty animals (A), 2) twenty images of different plant (P), 3) Twenty images of people of different professions (H) which is present with an artificial sound called Novel 20msec and.Thus, each pair of stimulus is presented for 100 milliseconds, at intervals of one second of duration between each block. The objective of is to press a button as quickly as possible while observing the pairs AA, situation called GO, while trying not to press when observes other types of pairs. This latency of response (reaction time) was mensured. Pairs are called GO(AA) NOGO(AP), IGNORE(PP) and NOVEL(PH + Sound). Errors by omission (lack of response in test GO) and by commission (lack of suppression in NOGO test) were be automatically counted for each subject."|From September to December 2012||||milliseconds||Standard Deviation|Mean
2652939|NCT01647542|Secondary|Percentage of Participants With HbA1c <7% at Week 24||Week 24|FAS included of all randomized participants who received at least 1 dose of double blind study medication. Only Participants with a baseline and at least 1 post baseline value were included.|||Percentage of participants|||Number
2652755|NCT01649232|Secondary|Event-related Potentials Latency (ERPs)|ERPs to the GO/NOGO task will be examined for changes as a result of treatment. Assessments were made at baseline (before stimulation), after the 10-12 days of stimulation, and at 1 and 3 months after stimulation. Event related potentials (ERP) generated from a visual continuous performance task (VCPT) are employed to access the early stages of information processing (Mueller et al., 2011; Kropotov, 2008) and performing at a GO/NOGO paradigm may be used to study the mechanisms of the brain's executive functions (Falkenstein et al., 1995). Amplitude and latency of ERP activity recorded from a subject can be compared to normalized databases to predict a possible hyper or hypo function of cerebral circuits. These ERP were recorded on 19 separeted channels according international 10-20 system. Electrode names are derived by brain lobule which is is located below and position, e.g., Pz is Parietal on position zero (midline) and Cz is Central Midline.|From September to December 2012||||milliseconds||Standard Deviation|Mean
2652756|NCT01649232|Secondary|Event-related Potentials Amplitude (ERPs)|ERPs to the GO/NOGO task will be examined for changes as a result of treatment. Assessments were made at baseline (before stimulation), after the 10-12 days of stimulation, and at 1 and 3 months after stimulation. Event related potentials (ERP) generated from a visual continuous performance task (VCPT) are employed to access the early stages of information processing (Mueller et al., 2011; Kropotov, 2008) and performing at a GO/NOGO paradigm may be used to study the mechanisms of the brain's executive functions (Falkenstein et al., 1995). Amplitude and latency of ERP activity recorded from a subject can be compared to normalized databases to predict a possible hyper or hypo function of cerebral circuits. These ERP were recorded on 19 separeted channels according international 10-20 system. Electrode names are derived by brain lobule which is is located below and position, e.g., Pz is Parietal on position zero (midline) and Cz is Central Midline.|From September to December 2012|The number of participants needed for study completion is between 20 and 40 for pilot study if it is homogeneous in patients with clinical signs and symptoms, to test efficacy and safety of noninvasive Brain Stimulation.|||microVolts||Standard Deviation|Mean
2652757|NCT01649232|Primary|Clinical Assessment (Amen Questionnaire)|"The Amen Attention Deficit Disorder (ADD) Type Questionnaire is a 71-question self-test that evaluates the ADD syndrome. 0 never, 1 rarely, 2 Occasionally, 3 Often and 4 Very Often. Consists of a series of questions that evaluate five brain systems: basal ganglia (23 items), Cingular System (17 items), Temporal System (16 items), Prefrontal Cortex (24 items) and deep limbic system (20 items). Each system has a maximum score of 4, and if this punctuation is greater than 1.7 it is possible that the system is deviated from normality and implicated in AD/HD behavior.~The minimal average score is 5 (Best) and the maximum is 20 (Worst). More than four is suspicious of diagnosis, six or more of a score of three or four is needed to make diagnosis. Meets the criteria for inattentiveness (six or more on questions 1-14) and also scores six or more on the cingular system questions (24-36 items), over-focused ADD subtype is suspected."|From September to December 2012|The number of participants needed for study completion is between 20 and 40 for pilot study if it is homogeneous in patients with clinical signs and symptoms, to test efficacy and safety of noninvasive Brain Stimulation.|||units on a scale||Standard Deviation|Mean
2652758|NCT01649180|Secondary|Tumor Tissue Banking|"To bank tumor tissue (formalin-fixed, paraffin-embedded tumor blocks) for retrospective examination of the molecular pathophysiologic mediators of tumorigenesis and progression such as phospho-protein expression of MAPK signaling network intermediates in endothelial cells. Banking of tumor tissue is optional but strongly encouraged.~Note: None of the 3 patients submitted tumor tissues so the analysis won't be performed."|Baseline|||||||
2652759|NCT01649180|Secondary|Biospecimen Banking for SNPs Analysis|"To bank biospecimens for the retrospective determination of whether baseline single nucleotide polymorphisms (SNPs) in angiogenesis-related genes predict response to treatment (candidate gene approach). Banking of PBMC is optional but strongly encouraged.~Note: The SNP genotyping analysis was not performed because the study stopped early and only 3 patients were enrolled. Therefore, the analysis to evaluate the association between baseline SNPs in angiogenesis-related genes and response was not be done."|Baseline|||||||
2652760|NCT01649180|Secondary|Biospecimen Banking for IL-8 and VEGF-A|"To bank biospecimens for the retrospective determination of whether baseline or changes in cytokine levels of IL-8 and VEGF-A predict response to treatment in this setting. Banking of plasma and serum is optional but strongly encouraged.~Note: The assays to assess cytokine levels of IL-8 and VEGF-A were not performed because the study stopped early and only 3 patients were enrolled. Therefore, the analysis to evaluate the associations between response and IL-8 as well as VEGF-A was not be done."|Baseline and 8 weeks|||||||
2652761|NCT01649180|Secondary|Overall Response Rate|"Best overall response was evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0). Response is defined as complete response or partial response.~Complete Response (CR): disappearance of all target lesions Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions"|Assessed every 12 weeks up to 36 months|all participants|||proportion of participants||95% Confidence Interval|Number
2652762|NCT01649180|Primary|Progression-free Survival|Progression-free survival is defined as the time from registration to disease progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Assessed every 12 weeks up to 36 months|all participants|||months||95% Confidence Interval|Median
2652763|NCT01648920|Primary|FeNO Values by Smoking Status: FeNO >= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO >=50ppb who either did not smoke previously or are current smokers."|approximately 1-hour||||participants|||Number
2652764|NCT01648920|Primary|FeNO Values by Smoking Status: FeNO >= 25ppb to <= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO >=25ppb to <=50ppb who either did not smoke previously or are current smokers."|approximately 1-hour||||participants|||Number
2652765|NCT01648920|Primary|FeNO Values by Smoking Status: FeNO <25ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO <25ppb who either did not smoke previously or are current smokers."|approximately 1-hour||||participants|||Number
2652766|NCT01648920|Primary|FeNO Values by ICS Use: FeNO >= 25ppb to <= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO <=25ppb to <=50ppb who either did not use Inhaled Corticosteroids (ICS) or did use Inhaled Corticosteroids."|approximately 1-hour||||participants|||Number
2652767|NCT01648920|Primary|FeNO Values by ICS Use: FeNO >= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO >=50ppb who either did not use Inhaled Corticosteroids (ICS) or did use Inhaled Corticosteroids."|approximately 1-hour||||participants|||Number
2652768|NCT01648920|Primary|FeNO Values by ICS Use: FeNO <25ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests were compared against final asthma diagnosis. Data are presented for participants with FeNO <25ppb who either did not use Inhaled Corticosteroids (ICS) or did use Inhaled Corticosteroids."|approximately 1-hour||||participants|||Number
2652769|NCT01648920|Primary|Negative Predictive Value (%) for FeNO|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Negative predictive value is a way of saying the likelihood of a negative test means you do not have disease. In this study it is defined as the percentage of study participants with a low FeNO who do not have asthma."|approximately 1-hour||||percent|||Number
2652770|NCT01648920|Primary|Positive Predictive Value (%) for FeNO|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Positive predictive value is a way of saying the likelihood a positive test means you have a disease. In this study, it is defined as the percentage of study participants with a high FeNO who have asthma."|approximately 1-hour||||percent|||Number
2652771|NCT01648920|Primary|Specificity (%) for FeNO|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Specificity is a way of saying how likely a test is negative if you do not have a disease and is expressed as (%) percent. For this study, specificity was the ability of FeNO to correctly identify a study participant who does not have asthma."|approximately 1-hour||||percent|||Number
2652772|NCT01648920|Primary|Sensitivity (%) for FeNO|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. Sensitivity is a way of saying how likely a test is positive if you have a disease and is expressed as (%) percent. For this study, sensitivity was the ability of FeNO to correctly identify a study participant who has asthma."|approximately 1-hour||||percent|||Number
2652773|NCT01648920|Primary|Asthma Diagnosis by FeNO: Mean FeNO Value|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour||||Parts per billion (ppb)||Standard Deviation|Mean
2652774|NCT01648920|Primary|Asthma Diagnosis by FeNO: FeNO >50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour||||participants|||Number
2652775|NCT01648920|Primary|Asthma Diagnosis by FeNO: FeNO >=25ppb to <= 50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour||||participants|||Number
2652828|NCT01648491|Secondary|Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA)|The GRA measures overall improvement with therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Markedly Improved, 2 Moderately Improved, 3 Slightly Improved, 4 No Change, 5 Slightly Worse, 6 Moderately Worse, and 7 Markedly Worse.|6 months||||units on a scale|||Number
2652776|NCT01648920|Primary|Asthma Diagnosis by FeNO: FeNO <25ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour||||participants|||Number
2652777|NCT01648920|Primary|Asthma Diagnosis by MCC Results: Negative MCC Response|"Fractional Exhaled Nitric Oxide (FeNO) measurements was performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline."|approximately 1-hour||||participants|||Number
2652778|NCT01648920|Primary|Asthma Diagnosis by MCC Results: Positive MCC Response|"Fractional Exhaled Nitric Oxide (FeNO) measurements was performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests were performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine."|approximately 1-hour||||participants|||Number
2652779|NCT01648920|Primary|FeNO by Methacholine Challenge (MCC) Results: FeNO >50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline."|approximately 1-hour|Participants with FeNO >50ppb|||participants|||Number
2652780|NCT01648920|Primary|FeNO by Methacholine Challenge (MCC) Results: FeNO >=25ppb to <=50ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline."|approximately 1-hour|Participants with FeNO >= 25 ppb to <= 50 ppb|||participants|||Number
2652781|NCT01648920|Primary|FeNO by Methacholine Challenge (MCC) Results: FeNO <25ppb|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis. A positive response to methacholine challenge is defined as a greater than or equal to 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline in response to methacholine. A negative response to methacholine challenge is defined as a less than 20% decrease in FEV1 at a methacholine dose less than or equal to 16mg/ml from baseline."|approximately 1-hour|Participants with a FeNO < 25 ppb|||participants|||Number
2652782|NCT01648920|Primary|Mean FeNO Levels by Methacholine Challenge (MCC) Results: MCC Results|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour||||parts per billion (ppb)||Standard Deviation|Mean
2652783|NCT01648920|Primary|Methacholine Challenge (MCC) Results|"Fractional Exhaled Nitric Oxide (FeNO) measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011). Methacholine Challenge (MCC) tests will be performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests. Values from the two tests will be compared against final asthma diagnosis."|approximately 1-hour||||participants|||Number
2652784|NCT01648790|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Test Formulation in Fasted and Fed State|AUC(0-tlast) = area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) specific to the 5 mg prasugrel dosing in the fasted and fed state. Pharmacokinetics will measure prasugrel's active metabolite.|Predose through 8 Hours Post Dose|Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.|||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2652785|NCT01648790|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State|Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) specific to the 5 mg prasugrel dosing in the fasted and fed state. Pharmacokinetics will measure prasugrel's active metabolite.|Predose through 8 Hours Post Dose|Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2652843|NCT01648452|Primary|Number of Severe Adverse Events at Six Months Post-Implantation|The number of severe adverse events reported within six months post-implantation.|Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation||||Adverse Events|||Number
2652786|NCT01648790|Primary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation|AUC(0-tlast) = area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 mg prasugrel dosing. Pharmacokinetics will measure prasugrel's active metabolite.|Predose through 8 Hours Post Dose|Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.|||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2652787|NCT01648790|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation|Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 milligrams (mg) prasugrel dosing. Pharmacokinetics will measure prasugrel's (LY640315) active metabolite.|Predose through 8 Hours Post Dose|Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2652788|NCT01648764|Secondary|Pharmacokinetics: Minimum Plasma Concentration (Cmin)|Cmin for LY2334737 and its metabolite 2'2'-difluorodeoxycytidine (dFdC).|Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7, 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle|All participants who received at least 1 dose of study drug and had Cmin values|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2652789|NCT01648764|Secondary|Percentage of Participants With Changes in R-R Interval From Baseline|Changes in R-R interval from baseline was calculated using a time matched approach, that is change from baseline was calculated by subtracting the respective reading taken at the same nominal time on Day -1 from the reading taken on Days 1 and 21; change from baseline was calculated by subtracting the last non-missing electrocardiogram (ECG) assessment on or prior to Day 1 and 0.5 hours prior to dose for Day 2 and Day 22. Percentage of participants with changes in R-R interval from baseline was calculated as the number of participants with a change not equal to 0 across all time points divided by the number of treated participants multiplied by 100.|Day -1: 24.5 hours, 22 hours and 17 hours predose; Cycle 1 Days 1 and 21: 0.5 hours predose, 2 hours, 7 hours and 24 hours postdose|All participants who received at least 1 dose of study drug with R-R interval data at all time points.|||percentage of participants|||Number
2652790|NCT01648764|Other Pre-specified|Number of Participants With Dose-Limiting Toxicity (DLT)|DLT was defined as an adverse event (AE) during Cycle 1 that was likely related to the LY2334737 and fulfilled any of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 nonhematological (except nausea/vomiting controlled with treatment); Grade 3 neutropenia with fever or any Grade 4 neutropenia with or without fever; Grade 3 thrombocytopenia with ≥ Grade 2 bleeding or Grade 4 thrombocytopenia; with or without bleeding A recovery period longer than 14 days from the last dose of LY2334737 to values allowing Cycle 2 to start; other significant drug-related toxicity deemed by the investigator to be dose limiting or that caused the participant to withdraw from the study.|Cycle 1 (28-day cycle)|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2652791|NCT01648764|Secondary|Percentage of Participants With Changes in QT Interval (>30 Milliseconds) From Baseline|Fridericia-corrected QT (QTcF) interval corrected for heart rate was assessed using triplicate 12-lead electrocardiograms (ECGs). Change in QT interval from baseline was calculated using a time matched approach, that is change from baseline was calculated by subtracting the respective reading taken at the same nominal time on Day-1 from the reading taken on Days 1 and 21; change from baseline was calculated by subtracting the last non-missing ECG assessment on or prior to Day 1, 0.5 hours prior to dose from assessment on Day 2 and Day 22. The outlying QTcF intervals were defined using the criteria: change from baseline in mean QTcF interval >30 milliseconds|Day -1: 24.5 hours, 22 hours and 17 hours predose; Cycle 1 Days 1 and 21, 0.5 hours predose, 2 hours, 7 hours and 24 hours postdose (28-day cycles)|All participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2652792|NCT01648764|Secondary|Progression-Free Survival (PFS)|"PFS was defined as the time from date of first dose to the first observation of disease progression or death due to any cause.~Due to the different tumor types, schedules and doses, the PFS was not analyzed."|Baseline to measured disease progression or death up to 33 weeks|Zero participants analyzed. No data collected for PFS.||||||
2652793|NCT01648764|Secondary|Number of Participants With Best Overall Response (BOR)|Response defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria. Complete Response defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Partial Response defined as ≥30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD) defined as ≥20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions, or appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Stable Disease was defined as small changes that did not meet above criteria and unknown defined as response status was not known. The BOR was the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started).|Baseline to measured disease progression up to 33 weeks|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2652794|NCT01648764|Secondary|Pharmacokinetics: Maximum Plasma Concentration (Cmax)|Cmax for LY2334737 and its metabolites 2'2'-difluorodeoxycytidine (dFdC) and difluorodeoxyuridine (dFdU).|Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle|All participants who received at least 1 dose of study drug and had Cmax values.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2652844|NCT01648452|Primary|Number of Adverse Events at Six Months Post-Implantation|The primary outcome is the total number of adverse events reported within six months post-implantation.|Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation||||Adverse Events|||Number
2652795|NCT01648764|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for Difluorodeoxyuridine (dFdU)|Daily AUC from time 0 to 24 hours (AUC 0-24) of dFdU (a metabolite of LY2334737) for Arm A (single dose of LY2334737) and Arm B (multiple doses of LY2334737).|Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle|All participants who received at least 1 dose of study drug and had AUC0-24 dFdU results.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2652796|NCT01648764|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for 2'2'-Difluorodeoxycytidine (dFdC)|AUC over the dosing interval (AUC0-Ƭ) of dFdC (a metabolite of LY2334737) for Arm A (following a single dose of LY2334737) AUC0-Ƭ is 0-48 hours postdose, Arm B (following multiple doses of LY2334737) AUC 0-Ƭ is 0-24 hours postdose and AUC from time 0 to infinity (AUC0-∞).|Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours post dose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours post dose of 28-day cycle|All participants who received at least 1 dose of study drug and had AUC 0-Ƭ and AUC 0-∞ values.|||nanograms*hours/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2652797|NCT01648764|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) for LY2334737|AUC over the dosing interval (AUC0-Ƭ) of LY2334737 for Arm A (single dose) is 0 to 48 hours postdose. AUC0-Ƭ of LY2334737 for Arm B (multiple doses) is 0 to 24 hours postdose and AUC time 0 to infinity (AUC0-∞) for LY2334737.|Cycle 1 Day 1 (C1 D1): 0.5, 1.5, 2, 3.5, 7 24 hours postdose; Cycle 1 Day 21 (C1 D21): predose, 0.5, 2, 3 to 4, 7, 24 hours postdose of 28-day cycle|All participants who received at least 1 dose of study drug and had AUC0-Ƭ and AUC0-∞ values.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2652798|NCT01648764|Primary|Recommended Dose for Phase 2 Studies|Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). The MTD was the highest dose level at which <2 out of 6 participants experienced a dose-limiting toxicity (DLT) in Cycle 1. DLT was an adverse event (AE) during Cycle 1 that was likely related to LY2334737 and fulfilled any of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 nonhematological (except nausea/vomiting controlled with treatment); Grade 3 neutropenia with fever or any Grade 4 neutropenia with or without fever; Grade 3 thrombocytopenia with ≥Grade 2 bleeding or Grade 4 thrombocytopenia with or without bleeding; A recovery period longer than 14 days from last dose of LY2334737 to values allowing Cycle 2 to start; Other significant drug-related toxicity deemed by investigator to be dose limiting or that caused the participant to withdraw from the study. Pharmacokinetics and pharmacodynamics (PK/PD) were also taken into consideration for Phase 2 recommended dose.|Baseline up to 28 days postdose in Cycle 1 (28-day cycle)|All participants who received at least 1 dose of study drug during dose escalation and dose confirmation treatment arms.|||mg every other day for 21 days|||Number
2652799|NCT01648699|Secondary|Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician|"The Clinical Global Impression (CGI) rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant, which ranges from very much worse to very much improved (as compared to Baseline)."|Day 28|"ITT population included all participants who received at least one dose of study medication at Baseline. n signifies those participants who were evaluated for this measure at the specified time point. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."|||Participants|||Number
2652800|NCT01648699|Secondary|Number of Participants Given Rescue Pain Medications|Rescue medication was a medication intended to relieve symptoms immediately. Rescue medication of morphine was used during the study duration and dose was set at 10-15 percent of the total daily morphine dose which ranged from 10-60 milligram.|Day 28|ITT population included all participants who received at least one dose of study medication at Baseline. 'N ' (number of participants analyzed) signifies the participants evaluable for this measure.|||Participants|||Number
2652801|NCT01648699|Primary|Brief Pain Inventory (BPI) Average Score at Day 28|The BPI assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely.|Day 28|ITT population included all participants who received at least one dose of study medication at Baseline. 'N ' (number of participants analyzed) signifies the participants evaluable for this measure.|||Units on a scale||Standard Deviation|Mean
2652802|NCT01648699|Primary|Brief Pain Inventory (BPI) Average Score at Baseline|The Brief Pain Inventory (BPI) assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely.|Baseline|Intent-to-treat (ITT) population included all participants who received at least one dose of study medication at Baseline.|||Units on a scale||Standard Deviation|Mean
2652803|NCT01648582|Secondary|Change From Baseline in EQ-5D Visual Analog Scale Score|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score was self-reported using a visual analogue scale (VAS) marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS means of change from baseline were calculated using ANCOVA and adjusted by treatment, country, and baseline.|Baseline, 26 weeks, 52 weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.|||units on a scale||Standard Deviation|Mean
2652804|NCT01648582|Secondary|EQ-5D Health State Score Responses|The EQ-5D questionnaire is a widely used, generic questionnaire that assesses health-related quality of life. It consists of 2 parts. The first part assesses 5 dimensions associated with quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 possible levels of response: no problem, some problem, and extreme problem. Additional categories of response include ambiguous and missing. The number of participants per each of the 3 response categories is summarized for each of the 5 dimensions.|Baseline, 26 Weeks, 52 Weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.|||participants|||Number
2653000|NCT01646346|Primary|Patients With Reduction in Incidental Radiation|Patients were assessed to determine if there was a reduction in breast radiation V50 less than 45% and V100 less than 23.5%.|5 day||||Participants|||Count of Participants
2652805|NCT01648582|Secondary|Percentages of Participants Developing Treatment-Emergent Dulaglutide Anti-drug Antibody (ADA)|Number of participants with treatment emergent (TE) dulaglutide anti-drug antibodies from postbaseline to follow up were summarized. A participant was considered to have TE dulaglutide ADA if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline through 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||Percentage of participants|||Number
2652806|NCT01648582|Secondary|Change in Body Mass Index|Body mass index is an estimate of body fat based on body weight divided by height squared.|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||kilogram/square meter (kg/m2)||Standard Error|Least Squares Mean
2652807|NCT01648582|Secondary|Change From Baseline in Body Weight||Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||kilogram (kg)||Standard Error|Least Squares Mean
2652808|NCT01648582|Secondary|Number of Participants With Adjudicated Pancreatitis|The number of participants with pancreatitis confirmed by adjudication is summarized. Events of pancreatitis (including suspected pancreatitis and severe or serious abdominal pain) were adjudicated by a committee of expert physicians external to the Sponsor. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||participants|||Number
2652809|NCT01648582|Secondary|Number of Participants With Adjudicated Cardiovascular (CV) Events|Deaths and nonfatal cardiovascular adverse events were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular events subjected to adjudication included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 52 weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||participants with adjudicated CV events|||Number
2652810|NCT01648582|Secondary|Change From Baseline in Serum Calcitonin||Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||picomole/liter||Standard Deviation|Mean
2652811|NCT01648582|Secondary|Change From Baseline in Pancreatic Enzymes|Amylase (total and pancreas-derived) and lipase concentrations were measured|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||Units/Liter (U/L)||Standard Deviation|Mean
2652812|NCT01648582|Secondary|Change From Baseline in Electrocardiogram Parameters, Heart Rate (HR)||Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||beats per minute (bpm)||Standard Deviation|Mean
2652813|NCT01648582|Secondary|Change From Baseline in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex.|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||millisecond (msec)||Standard Deviation|Mean
2652814|NCT01648582|Secondary|Change From Baseline at 26 Weeks and 52 Weeks on Pulse Rate|Seated pulse rate was measured. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2652815|NCT01648582|Secondary|Change From Baseline to 26 Weeks and 52 Weeks on Blood Pressure (BP)|Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured. LS means of change from baseline were calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.|Baseline, 26 Weeks, 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||millimeters of mercury (mmHg)]||Standard Error|Least Squares Mean
2652816|NCT01648582|Secondary|Number of Self-reported Hypoglycemic Events|Hypoglycemic events (HE) were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia, and had a plasma glucose level of less than or equal to 3.9 millimoles/liter [mmol/L]), asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 3.9 mmol/L), nocturnal (defined as any hypoglycemic event that occurred between bedtime and waking), or probable symptomatic (defined as events during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination). The number of self-reported hypoglycemic events was summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks and 52 Weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||percentage of participants|||Number
2652817|NCT01648582|Secondary|Rate of Hypoglycemic Events|Hypoglycemic events (HE) were classified as documented symptomatic hypoglycemia, asymptomatic hypoglycemia, severe hypoglycemia, and probable symptomatic hypoglycemia. The 1-year adjusted rate of HEs was summarized cumulatively at 26 weeks and 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and 52 weeks|Participants in the safety population who were randomized and received at least one dose of study drug.|||events per participant per year||Standard Deviation|Mean
2652818|NCT01648582|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks and 52 Weeks|The HOMA2 was used to estimate the steady-state insulin sensitivity (%S). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of the normal reference population. LS means were calculated using an homeostasis model assessment with change from baseline in HOMA-%S as a covariate and country, baseline measurement, OAM, and treatment as fixed effects.|Baseline, 26 Weeks, 52 Weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method. HOMA2 was not evaluated for insulin glargine, as the use of this model has not been validated in participants treated with insulin.|||percentage of HOMA2-%S||Standard Error|Least Squares Mean
2652819|NCT01648582|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks and 52 Weeks|The updated Homeostasis Model Assessment (HOMA2) was used to quantify steady state beta-cell function (%B). HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate %B as a percentage of a normal reference population. LS means were calculated using a homeostasis model assessment with change from baseline in HOMA-%B as a covariate and country, baseline measurement, OAM, and treatment as fixed effects.|Baseline, 26 weeks, 52 weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method. HOMA2 was not evaluated for insulin glargine, as the use of this model has not been validated in participants treated with insulin.|||percentage of HOMA2-%B||Standard Error|Least Squares Mean
2652820|NCT01648582|Secondary|Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks and 52 Weeks|Participants were required to perform 7-point SMBG profiles on 2 separate, nonconsecutive days during the 2 weeks before randomization and Weeks 8, 14, 20, 26, 39, and 52 (or the Early Discontinuation Visit). SMBG measurements were taken using a plasma-equivalent blood glucose (BG) meter at 7 time points: morning pre-meal, morning 2 hours post-meal, mid-day pre-meal, mid-day 2 hours post-meal, evening pre-meal, evening 2 hours post-meal, and at bedtime. Mean and Week 26 and Week 52 was assessed in all treatment groups. LS means of change from baseline were calculated using MMRM with the change in 7-point SMBG as the dependent variable and treatment, baseline value, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.|Baseline, 26 Weeks, 52 Weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.|||mmol/L||Standard Error|Least Squares Mean
2652821|NCT01648582|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks|LS means of change from baseline were calculated using MMRM with the change in FBG as the dependent variable and treatment, baseline value, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.|Baseline, 26 Weeks, 52 Weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2652822|NCT01648582|Secondary|Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks and 52 Weeks|The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.|Up to 26 and 52 weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline. Missing endpoints were imputed with the last observation carried forward (LOCF) method.|||percentage of participants|||Number
2652823|NCT01648582|Secondary|Change From Baseline in HbA1c at 52 Weeks|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS means of change from baseline in HbA1c were calculated using a MMRM with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, OAM, visit, and treatment-by-visit interaction as fixed effects, and participant was as the random effect.|Baseline, 52 Weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
2652824|NCT01648582|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means of change from baseline in HbA1c were calculated using a mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, baseline HbA1c, country, oral antihyperglycemic medication (OAM) , visit, and treatment-by-visit interaction as fixed effects, and participant was the random effect.|Baseline, 26 Weeks|Participants who were randomized, received at least one dose of study drug, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
2652825|NCT01648530|Primary|Migraine Disability Assessment (MIDAS)|The Midas score is a patient completed 5-item questionnaire about lost time and productivity (for work, school or family/social activities) in the past 3 months (number of days missed) where: 0-5=Little or No disability, 6-10=Mild disability, 11-20=Moderate disability or 21+ Severe disability. The Midas scores assessed at Months 3, 6, 9 and 12 were averaged.|12 Months|All qualified participants at Baseline who returned completed survey with positive screening for migraines.|||days||Standard Deviation|Mean
2652826|NCT01648530|Primary|Percentage of Participants With Episodic Migraine (EM) or Chronic Migraine (CM)|EM is defined as <15 headache days/month and CM is defined as ≥15 headache days/month.|Baseline|All qualified participants at Baseline who returned completed survey with positive screening for migraines.|||percentage of participants|||Number
2652827|NCT01648491|Secondary|Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I)|The PGI-I is a global index used to rate the response of a condition to a therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Very Much Better, 2 Much Better, 3 A Little Better, 4 No Change, 5 A Little Worse, 6 Much Worse, and 7 Very Much Worse.|6 months||||units on a scale|||Number
2653238|NCT01644474|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2652829|NCT01648491|Secondary|Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire|"The PGI-S is comprised of two questions. Question 1 asks the patient to describe how their urinary tract condition is now. Responses are 1 Normal, 2 Mild, 3 Moderate and 4 Severe. Question 2 asks the patient If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Responses are 1 Delighted, 2 Pleased, 3 Mostly Satisfied, 4 Mixed, 5 Mostly Dissatisfied, 6 Unhappy and 7 Terrible."|Baseline and 6 months||||units on a scale|||Number
2652830|NCT01648491|Primary|Study-Related Adverse Events||6 months||||Adverse Events|||Number
2652831|NCT01648452|Secondary|Number of Participants Who Experienced an Improvement in Color Discrimination and/or Matching Post-Implantation in the Untreated Control Eye.|Color hue discrimination was tested by the Nagel anomaloscope, American Optical Hardy Rand Rittler (AOHRR) color plates, and a low vision version of the Cambridge Color Test (LvCCT) implemented on a ViSaGe System (Cambridge Research Systems Ltd., Rochester, UK) using custom-written software. Hardy Rand Rittler testing followed the guidelines accompanying the test and administered under a Macbeth Lamp at 300 lux.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||participants|||Number
2652832|NCT01648452|Secondary|Number of Participants Who Experienced an Improvement in Color Discrimination and/or Matching Post-Implantation in the Study Eye.|Color hue discrimination was tested by the Nagel anomaloscope, American Optical Hardy Rand Rittler (AOHRR) color plates, and a low vision version of the Cambridge Color Test (LvCCT) implemented on a ViSaGe System (Cambridge Research Systems Ltd., Rochester, UK) using custom-written software. Hardy Rand Rittler testing followed the guidelines accompanying the test and administered under a Macbeth Lamp at 300 lux.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||participants|||Number
2652833|NCT01648452|Secondary|Number of Participants Who Experienced an Increase in Either the Rod or Cone Electroretinogram (ERG) Responses of More Than 75% Post-Implantation in the Untreated Control Eye.|Full-ﬁeld ERGs were recorded according to International Society of Clinical Electrophysiology of Vision Standards (ISCEV).|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||participants|||Number
2652834|NCT01648452|Secondary|Number of Participants Who Experienced an Increase in Either the Rod or Cone Electroretinogram (ERG) Responses of More Than 75% Post-Implantation in the Study Eye.|Full-ﬁeld ERGs were recorded according to International Society of Clinical Electrophysiology of Vision Standards (ISCEV).|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||participants|||Number
2652835|NCT01648452|Secondary|Number of Participants Who Experienced an Improvement in Visual Acuity of Greater Than 0.3 logMAR (Logarithm of the Minimum Angle of Resolution) Post-Implantation in the Untreated Control Eye.|"Improvement of visual acuity was assessed on both the study and control eyes. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. .~The LogMAR scale [expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30)] converts the geometric sequence of a traditional chart to a linear scale. It measures VA loss; positive values indicate vision loss, whereas negative values denote normal or better VA. A lower LogMAR value indicates better VA. For example, a visual acuity of 20/20 corresponds to a logMAR value of zero (0), and a visual acuity of 20/100 corresponds to a LogMAR value of 0.7."|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||participants|||Number
2652836|NCT01648452|Secondary|Number of Participants Who Experienced an Improvement in Visual Acuity of Greater Than 0.3 logMAR (Logarithm of the Minimum Angle of Resolution) Post-Implantation in the Study Eye.|"Improvement of visual acuity was assessed on both the study and control eyes. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. .~The LogMAR scale [expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30)] converts the geometric sequence of a traditional chart to a linear scale. It measures VA loss; positive values indicate vision loss, whereas negative values denote normal or better VA. A lower LogMAR value indicates better VA. For example, a visual acuity of 20/20 corresponds to a logMAR value of zero (0), and a visual acuity of 20/100 corresponds to a LogMAR value of 0.7."|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||participants|||Number
2652837|NCT01648452|Secondary|Number of Non-Ocular Adverse Events at All Time Points Post-Implantation|The total number of non eye-related adverse events reported from Day 1 post-implantation through study completion at Year 3.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||Adverse Events|||Number
2652838|NCT01648452|Secondary|Number of Ocular Adverse Events at All Time Points Post-Implantation|The total number of eye-related adverse events reported from Day 1 post-implantation through study completion at Year 3.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||Adverse Events|||Number
2652839|NCT01648452|Secondary|Number of Severe Adverse Events at All Time Points Post-Implantation|"The total number of severe adverse events reported from Day 1 post-implantation through study completion at Year 3.~Although there were two serious adverse events (SAEs) reported during the study, only one event's severity was classified as severe."|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||Adverse Events|||Number
2652840|NCT01648452|Secondary|Number of Adverse Events at All Time Points Post-Implantation|The total number of adverse events reported from Day 1 post-implantation through study completion at Year 3.|Day 1, Week 1, Week 4, Week 12, Week 24, Week 52, Week 78, Week 156 post-implantation||||Adverse Events|||Number
2652841|NCT01648452|Primary|Number of Non-Ocular Adverse Events at Six Months Post-Implantation|The number of non eye-related adverse events reported within six months post-implantation.|Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation||||Adverse Events|||Number
2652842|NCT01648452|Primary|Number of Ocular Adverse Events at Six Months Post-Implantation|The number of eye-related adverse events reported within six months post-implantation.|Day 1, Week 1, Week 4, Week 12, Week 24 post-implantation||||Adverse Events|||Number
2652845|NCT01648348|Other Pre-specified|Changes in Tumor and Circulating Biomarkers|Binary endpoints and categorical endpoints will be compared using Chi-Squared or Fisher's Exact tests between treatment groups. Continuous endpoints will be analyzed using change-from-baseline measures and compared using t-tests between treatment groups and time-points. Cox proportional hazards regression will be used to determine if there are differences in PFS and OS between the treatment groups after correcting for each biomarker in conjunction with standard clinical variables.|Baseline to up to 2 years|||||||
2652846|NCT01648348|Other Pre-specified|Change in MRI ADC Utility|MRI ADC histogram metrics such as overall ADC, mean ADC of lower curve, percentage of ADC in lower curve, and skewness at baseline and change from baseline to the first follow-up MRI will be analyzed for association with progression free and overall survival. Kaplan-Meier survival curves, logrank and Cox regression tests will be used to estimate and compare the equality of the overall survival and progression-time distributions of patient subsets defined by the ADC histogram metrics.|Baseline to up to 2 years|||||||
2652847|NCT01648348|Other Pre-specified|Change in DCE-MRI Utility|Associations between the change of DCE-MRI and PFS6 will be assessed using two-sample t-test.|Baseline to up to 2 years|||||||
2652848|NCT01648348|Secondary|QOL Assessed by WIWI Questionnaire (Phase II)|"Quality of life (QOL) assessed by Was it worth it? (WIWI) questionnaire, as measured by the percentage of patients answering yes to the question Was it worthwhile for you to participate in this research study?"|Up to 4 weeks|All phase II patients who completed the WIWI questionnaire were included in this analysis.|||percentage of patients answering yes|||Number
2652849|NCT01648348|Secondary|QOL Assessed by EORTC-QLQ-BN20 Patient Questionnaire [Items 1-20] (Phase II)|QOL assessed by EORTC-QLQ-BN20 Patient Questionnaire (Brain cancer module), as measured by the change from baseline to the end of cycle 2 (4 weeks) in the EORTC QLQ-BN20 Items 1-20 are used to score the following 11 symptom scales: Future uncertainty (Items 1-3,5), Visual disorder (Items 6-8), Motor dysfunction (Items 10,15, 19), Communication deficit (Items 11-13), Headaches (Item 4), Seizures (Item 9), Drowsiness (Item 14), Itchy Skin (Item 17), Hair Loss (Item 16), Weakness of legs (Item 18), and Bladder control (Item 20). The assessment was scored using EORTC's scoring algorithms. The score range for each of the 11 symptom scales is from 0-100 (0 corresponding to not severe;100 corresponding to most severe). Range of changes in scores from baseline to cycle 2 (4 weeks) is (-100,100). The mean change in score and 95% confidence interval of each symptom scale are reported below.|Baseline and 4 weeks|All phase II patients who completed the EORTC-QLQ-BN20 patient questionnaire at baseline and at the end of cycle 2 were included in this analysis.|||units on a scale||95% Confidence Interval|Mean
2652850|NCT01648348|Secondary|Quality of Life (QOL) as Assessed by the EORTC QLQ-C15-PAL Questionnaire [Item 15: Global Health Status/Quality of Life] (Phase II)|Quality of Life (QOL) as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C15-PAL questionnaire, as measured by the change from baseline to the end of cycle 2 (4 weeks) in the EORTC QLQ-C15-PAL item 15, Global health status/quality of life, score. The assessment was scored using EORTC's scoring algorithms. The score range is from 0-100 (0 corresponding to worst outcome; 100 corresponding to best outcome). Range of the change in scores from baseline to cycle 2 (4 weeks) is (-100,100). The mean change in score and 95% confidence interval of the change from baseline to the end of cycle 2 (4 weeks) are reported below.|Baseline and 4 weeks|All phase II patients who completed the EORTC QLQ-C15-PAL questionnaire at baseline and at the end of cycle 2 were included in this analysis.|||units on a scale||95% Confidence Interval|Mean
2652851|NCT01648348|Secondary|Progression Free Survival at 6 Months (PFS6) (Phase II) as Measured by the Percentage of Participants With Progression Free Survival at 6 Months|PFS6 is defined as the time from start of study therapy to the date of first observation of disease progression or death due to any cause (whichever comes first). The medians and confidence intervals given are the Kaplan-Meier estimates.|The time from study randomization to documentation of disease progression, assessed at 6 months|All phase II patients who started the study were eligible and included in this analysis.|||percentage of progression-free patients||95% Confidence Interval|Number
2652852|NCT01648348|Secondary|Overall Survival (Phase II)|Survival time is defined to be the length of time from start of study therapy to death due to any cause. All patients meeting the eligibility criteria that have signed a consent form and begun treatment will be considered evaluable for estimation of the survival distribution. The distribution of overall survival for both groups of the study will be estimated using the Kaplan-Meier method, and be compared using log-rank tests.|The time from start of study therapy to death due to any cause, assessed up to 2 years|All phase II patients who started the study were eligible and included in this analysis.|||months||95% Confidence Interval|Median
2652853|NCT01648348|Secondary|Overall Toxicity Rate for Grade 3 or Higher Adverse Events Considered at Least Possibly Related to Treatment (Phase II)|The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment will be compared using a Fisher's Exact test between the 2 treatment groups.|Up to 2 years|All phase II patients who completed the study were eligible and included in this analysis.|||percentage of patients|||Number
2652854|NCT01648348|Primary|Progression-free Survival (PFS) (Phase II)|Progression Free Survival time is defined as the time from study randomization to documentation of disease progression. Patients who die without documentation of progression will be considered to have had tumor progression at the time of death. Patients who fail to return for evaluation after beginning therapy will be censored for progression on the last day of therapy or date last known to be alive, whichever is later. Patients who are still alive and have not progressed will be censored for progression at the time of the last tumor assessment. The time-to-progression distribution will be estimated using the Kaplan-Meier method.|The time from study randomization to documentation of disease progression, assessed up to 2 years|All phase II patients who started the study were eligible and analyzed for the primary outcome of Phase II.|||months||95% Confidence Interval|Median
2652935|NCT01647711|Primary|Percentage of Participants With Dose Limiting Toxicities|Percentage of participants with Dose Limiting Toxicities (DLTs), based on investigator assessment, for determination of Maximum Tolerated Dose (MTD). MTD was defined as the dose in which less than 2 of up to 6 patients developed a DLT.|28 days|Treated set including patients eligible for MTD determination|||Percentage of participants|||Number
2652855|NCT01648348|Primary|Maximum Tolerated Dose (MTD) (Phase I) as Measured by the Number of Participants With Dose Limiting Toxicities|MTD for this study will be defined as the highest safely tolerated dose level where at most 1 out of 6 patients experience dose-limiting toxicity (DLT) with the next higher dose having at least 2 patients out of a maximum of 6 patients experience DLT. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of DLT's will be reported here.|28 days|All phase I patients who completed the study were eligible and analyzed for MTD.|||Participants|||Count of Participants
2652856|NCT01648322|Secondary|The Depth of the ANC Nadir for All Chemotherapy Cycles|The depth of ANC nadir for each cycle is defined as the minimal ANC value for a subject in each chemotherapy cycle. The depth of the ANC nadir for each arm of the study will be recorded for 4 chemotherapy cycles.|Measured for each of the 4, 21 day chemotherapy cycles|PP population|||x 10^9/L||Standard Deviation|Mean
2652857|NCT01648322|Secondary|The Incidence Rates of Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy Cycles|The incidence rate of mild, moderate and sever neutropenia for each arm of the study will be recorded for 4 chemotherapy cycles. Each cycle is expected to last 21 Days.|Measured for each of the 4, 21 day chemotherapy cycles.|PP population|||Participants|||Count of Participants
2652858|NCT01648322|Secondary|The Time to ANC Recovery Post Nadir|The time to ANC recovery post nadir for each patient, for each of their chemotherapy cycles will be recorded; recovery for this protocol is defined as achieving an ANC ≥ 2.0 × 10^9/L after the expected ANC nadir (expected nadir is typically 4-6 days post chemotherapy administration). Each chemotherapy cycle is expected to last 21 days.|Measured for each of the 4, 21 day chemotherapy cycles.|TAC PP population|||Days||Standard Deviation|Mean
2652859|NCT01648322|Secondary|The Duration in Days of Total Grade 2-4 Neutropenia|Number of says in which the patient has had an ANC Level ANC < 1.5 × 109/L) post each chemotherapy|Measured for each of the 4, 21 day chemotherapy cycles.|PP population|||Days||Standard Deviation|Mean
2652860|NCT01648322|Secondary|The Incidence Rate of Febrile Neutropenia|The incidence rate of febrile neutropenia for each arm of the study will be recorded for 4 chemotherapy cycles. Each cycle is expected to last 21 Days.|Measured for each of the 4, 21 day chemotherapy cycles.|PP population|||Participants|||Count of Participants
2652861|NCT01648322|Secondary|Duration in Days of Grade 3 and Grade 4 Neutropenia for All 4 Chemotherapy Cycles.|Number of days In which the patient has had an ANC < 1.0 × 10^9/L (Grade 3) or ANC < .5 × 10^9/L (Grade 4) post each chemotherapy|Measured for each of the 4, 21 day chemotherapy cycles.|PP population|||Days||Standard Deviation|Mean
2652862|NCT01648322|Primary|Duration of Moderate Neurtopenia Post First Chemotherapy Administration|Number of days In which the patient has had an absolute neutrophil count (ANC) Level < 2.0 x 10^9/L after first cycle of chemotherapy|The first of 4, 21 Day Chemotherapy Cycles|per protocol population|||days||Standard Deviation|Mean
2652863|NCT01648296|Secondary|To Determine Human Dosimetry Based on the Human Biodistribution of [18F](+/-)NOS in Both Normal Healthy Volunteers and Dilated Non-ischemic Cardiomyopathy Patients.|"A total of 0 subjects (Four normal healthy volunteer subjects and0 subjects with or without Type 2 Diabetes Mellitus with Chronic Dilated Cardiomyopathy)will receive a single intravenous injection of 10 mCi of[18F]FluorbetaOx followed by PET-CT imaging at two separate time points.~The difference between primary Outcome and the secondary outcome are the patients themselves. Florbeta Ox was measured in normal healthy volunteers and in non-ischemic cardiomyopathy patients through PET/CT image visualization."|2-3 days post [18F]FluorbetaOx injection|The PI has left the institution, and all efforts to locate this data have been exhausted and it therefore cannot be reported.||||||
2652864|NCT01648296|Primary|The Primary Endpoint is to Determine if PET/CT Measurements of Myocardial FA Metabolism Performed With [18F]FluorbetaOx Correlated With Those Performed With [11C]Palmitate and Calculation of Human Dosimetry.|"The values in the table represent the number of participants, specifically Dosimetry and Kinetic patients and that is how the primary endpoint is arrived at. This is how the primary endpoint is determined through PET/CT measurements of Myocardial FA metabolism with F-18 Florbeta Ox.~The data intended for this Outcome Measure use PET/CT images to visualize the amount of myocardial FA metabolism appears with the radio tracer, Florbeta Ox."|24-72 hrs|The PI has left the institution, all efforts to locate this data have been exhausted and it therefore cannot be reported||||||
2652865|NCT01648283|Primary|Methadone Metabolism|Plasma metabolite EDDP/methadone area under the concentration-time curve (AUC0-96) ratio|up to 96 hours|Plasma EDDP/methadone AUC ratio|||ratio||Standard Deviation|Mean
2652866|NCT01648270|Primary|Buprenorphine Plasma Cmax||96 hours|0 Participants Analyzed. The PI has left the institution. Sincere efforts were made to contact the PI but were unsuccessful. No study data are available.||||||
2652867|NCT01648166|Primary|Rate of Moderate to High Arsenic Level in Cases and Controls|Conduct a case-control study of lung cancer and matched controls in the 5th Congressional District of Kentucky to compare rates of moderate to high arsenic in lung cancer cases and controls (primary endpoint).|up to three years|those with adequate toenail arsenic concentrations|||mcg/dL||Inter-Quartile Range|Median
2652868|NCT01648140|Secondary|Correlation GSK2336805 Pre-dose Plasma Concentration on Day 2 Versus Reduction in HCV RNA on Day 2|Correlation GSK2336805 pre-dose plasma concentration (ng/mL) on Day 2 versus reduction in HCV RNA (log IU/mL) on Day 2 was performed. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.|Day 2|PK/PD Analysis Population||||||
2652869|NCT01648140|Secondary|Correlation of Individual GSK2336805 Dose With Pre-dose Plasma Concentration at Week 4 and Week 12 Versus eRVR Status|Correlation of individual GSK2336805 dose with pre-dose plasma concentration at Week 4 and Week 12 versus eRVR status was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. The PK/Pharmacodynamic (PD) analysis population comprised of all participants with available PD measures (e.g., safety and/or efficacy data) and with evaluable GSK2336805 plasma concentration data considered suitable for investigation of relationship with the PD measures. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.|Week 4 and Week 12|PK/PD Analysis Population||||||
2652870|NCT01648140|Secondary|Correlation of Individual GSK2336805 Dose With Week 4 Plasma Cmax, Ctau, C0 Versus RVR Status|Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus RVR status (RVR and no RVR) was performed. RVR is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.|Week 4|Intensive PK Population||||||
2652871|NCT01648140|Secondary|Correlation of Individual GSK2336805 Dose With Week 4 Plasma AUC(0-tau) Versus RVR Status|Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (RVR and no eVE) was performed. RVR is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.|Week 4|Intensive PK Population||||||
2652872|NCT01648140|Secondary|Correlation of Individual GSK2336805 Dose With Week 4 Plasma Cmax, Ctau, C0 Versus eRVR Status|Correlation of Individual GSK2336805 40 mg and 60 mg dose with Week 4 maximum plasma concentration (Cmax), pre-dose concentration (C0), concentration at the end of the dosing interval (Ctau) versus eRVR status (eRVR and no eRVR) was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected PK parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.|Week 4 and Week 12|Intensive PK Population||||||
2652873|NCT01648140|Secondary|Correlation of Individual GSK2336805 Dose With Week 4 Plasma AUC(0-tau) Versus eRVR Status|Correlation of individual GSK2336805 40 mg and 60 mg with Week 4 plasma AUC(0-tau) versus eRVR Status (eRVR and no eRVE) was performed. eRVR is defined as plasma HCV RNA <LLOQ and target not detected at Weeks 4 and 12. AUC (0-tau) is area under the concentration-time curve over the dosing interval. As defined in the RAP for this protocol, correlations between GSK2336805 dose, and selected pharmacokinetic parameters and virological outcomes was analyzed only with graphical presentations to facilitate clinical interpretation and data summarization. These data were also provided in by-participant data listings. Therefore, no statistical summary tables are available.|Week 4 and Week 12|Intensive PK Population||||||
2652874|NCT01648140|Secondary|Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of estimated creatinine clearance by Cockcroft-Gault formula at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the estimated creatinine clearance values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||mL/min||Standard Deviation|Mean
2652875|NCT01648140|Secondary|Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/BUN at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/bun at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Bun values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Millimoles per liter||Standard Deviation|Mean
2652876|NCT01648140|Secondary|Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval, QTcB, QTcF Values at the Indicated Time Points After Week 12|"The ECG data was only collected Perform as needed, therefore, no such summary table was generated. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed."|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population||||||
2652877|NCT01648140|Secondary|Mean Change From Baseline in ECG Heart Rate Values at the Indicated Time Points After Week 12|"The ECG data was only collected Perform as needed, therefore, no such summary table was generated. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed."|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population||||||
2652878|NCT01648140|Secondary|Mean Change From Baseline in Heart Rate at the Indicated Time Points After Week 12|Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from Baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. All abnormal values and statistical summary tables were not available after week 12.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population||||||
2659953|NCT01585441|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at Month 3 Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Month 3||||decibels|Participants|Standard Deviation|Mean
2652879|NCT01648140|Secondary|Mean Change From Baseline in SBP and DBP at the Indicated Time Points After Week 12|Blood pressure measurements were taken to observe vital signs and included SBP and DBP at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. As defined in the Reporting Analysis Plan (RAP) for this protocol, the supplemental final data package generated for this study after Week 12 only provided graphical displays of vital signs (e.g., change from baseline for heart rate and blood pressure) to facilitate clinical interpretation and data summarization. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed. All abnormal values and statistical summary tables were not available after week 12.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population||||||
2652880|NCT01648140|Secondary|Mean Change From Baseline in Total Bilirubin and Creatinine at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of total bilirubin and creatinine at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment afterl Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Micromoles per liter||Standard Deviation|Mean
2652881|NCT01648140|Secondary|Mean Change From Baseline in ALP, ALT, AST, CK and GGT at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||International units per liter||Standard Deviation|Mean
2652882|NCT01648140|Secondary|Mean Change From Baseline in Albumin at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of albumin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Grams per liter||Standard Deviation|Mean
2652883|NCT01648140|Secondary|Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of mean corpuscle volume at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Femtoliters||Standard Deviation|Mean
2652884|NCT01648140|Secondary|Mean Change From Baseline in Hematocrit at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of hematocrit at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Ratio||Standard Deviation|Mean
2652885|NCT01648140|Secondary|Mean Change From Baseline in Hemoglobin at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of hemoglobin at the the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Grams per liter||Standard Deviation|Mean
2652936|NCT01647581|Primary|Number of Patients With Delayed Post Polypectomy Bleeding|rectal bleeding with associated Hb 2g drop, hemodynamic instability, or need for repeat colonoscopy or angiography or surgery|30 days||||Participants|||Count of Participants
2653239|NCT01644474|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2652886|NCT01648140|Secondary|Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Trillion cells per liter||Standard Deviation|Mean
2652887|NCT01648140|Secondary|Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points After Week 12|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT Week 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils platelet count and white blood cell count values are summarized for each post-Baseline assessment after Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 18, 24, 30, 36, 42, 48 and PT FU Week 4|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Giga cells per liter||Standard Deviation|Mean
2652888|NCT01648140|Secondary|Apparent Volume of Distribution (Vz/F) at Week 4|Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. Vz/F was calculated as dose divided by (AUC[0-tau] lambda z) where lambda z is the terminal phase rate constant.|Week 4 (24 h post dose)|Intensive PK Summary Population|||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2652889|NCT01648140|Secondary|Apparent Clearance (CL/F) at Week 4|Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose. CL/F was calculated as dose divided by AUC(0-tau).|Week 4 (24 h post dose)|Intensive PK Summary Population|||Liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2652890|NCT01648140|Secondary|Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) at Week 4|Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7 and 24 hours postdose.|Week 4 (24 h post dose)|Intensive PK Summary Population|||hour*nanogram per milliliter(hr*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2652891|NCT01648140|Secondary|Time of Maximal Plasma Concentration (Tmax) of GSK2336805 at Week 4|Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours postdose.|Week 4 (24 h post dose)|Intensive PK Summary Population|||hour||Full Range|Median
2652892|NCT01648140|Secondary|Maximum Plasma Concentration (Cmax) and Concentration at the End of the Dosing Interval (Ctau) of GSK2336805 at Week 4|Blood samples for PK analysis of GSK2336805 was obtained on Week 4+1 day at predose and at 1, 2, 4, 7, 24 hours post-dose.|Week 4 (24 h post dose)|Intensive PK Summary Population: Intensive PK Summary Population comprised of participants with evaluable GSK2336805 PK parameters at Week 4. Only participants available at the indicated time point were assessed (represented by n=X, X in category titles).|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2652893|NCT01648140|Secondary|Mean GSK2336805 Plasma Concentrations on Day 1, Day 2, Week 4, and Week 12|Plasma pharmacokinetic (PK) samples were collected for all participants on Day 1 (0 hour [h]-1h, 1h-4h, 4h-8h, 8h-20h), Day 2 (Predose [20-28h]), Week 4 (Predose [20-28h], 0h-1h, 1h-4h, 4h-8h, 8h-20h, 20h-28h) and Week 12 (Predose [20-28h]). PK Population is comprised of all participants who received GSK2336805 and underwent plasma PK sampling (intensive or sparse) during the study.|Day 1, Day 2, Week 4, and Week 12|PK Population included all participants who received GSK2336805 and underwent plasma PK sampling (intensive or sparse) during the study. Only participants for whom plasma PK samples were obtained were assessed (represented by n=X, X in category titles).|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2652894|NCT01648140|Secondary|Number of Participants Achieving Very Rapid Virologic Response (vRVR), Rapid Virologic Response (RVR), Complete Early Virologic Response (cEVR), Sustained Virologic Response 12 and 24 (SVR12 and SVR24) With Response Guided Treatment (RGT)|Blood samples for the determination of HCV RNA levels were collected at Screening and Baseline, every study visit during the Treatment Period, and at PT FU Weeks 4, 12, and 24. vRVR is defined as plasma HCV RNA <LLOQ and target not detected 2 weeks after initiation of therapy. RVR is defined as plasma HCV RNA <LLOQ and target not detected 4 weeks after initiation of therapy. cEVR is defined as plasma HCV RNA <LLOQ and target not detected 12 weeks after initiation of therapy. SVR12 is defined as plasma HCV RNA <LLOQ and target not detected 12 weeks after completion of all therapy. SVR24 is defined as plasma HCV RNA <LLOQ and target not detected 24 weeks after completion of all therapy. SVR24 with RGT are participants who achieved both SVR24 and eRVR.|From the start of the treatment up to PT FU Week 24|ITT Population|||Participants|||Number
2652895|NCT01648140|Secondary|Number of Participants With Any AEs and Any SAEs After Week 12|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|From Week 12 up to PT Week 24 FU|Safety Population|||Participants|||Number
2653322|NCT01644240|Primary|Cmax|Maximum concentration in plasma following dosing on Day 1|Day 1|Sample size was 6 at all time points with the exception of 0.5 hours for dose 2 where value was considered an outlier and one subject was excluded from the PK analysis resulting in sample size of 5.|||pg/mL||Standard Deviation|Mean
2652896|NCT01648140|Primary|Mean Change From Baseline in PR Interval, QRS Duration, Uncorrected QT Interval and QT Interval Corrected Bazett's Formula (QTcB), QT Interval Corrected Using Fridericia's Formula (QTcF) Values at the Indicated Time Points up to Week 12|The ECG parameters including PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF were measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG parameters are summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Milliseconds||Standard Deviation|Mean
2652897|NCT01648140|Primary|Mean Change From Baseline in Electrocardiographic (ECG) Heart Rate Values at the Indicated Time Points up to Week 12|The ECG parameter heart rate was measured at Baseline, Weeks 1 and 12. Change from Baseline in ECG heart rate is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Beats per minute||Standard Deviation|Mean
2652898|NCT01648140|Primary|Number of Participants With Shift From Baseline in Urinalysis Data up to Week 12|Urine samples were collected for urinalysis at Baseline, Weeks 2, 12, 18, 24, 48 and PT FU Weeks 4. Number of participants with shift from Baseline in urinalysis to normal (NL), abnormal (ANL) and missing (MIS) data up to Week 12 are summarized. Urine bilirubin (UBIL), urine glucose (UGLU), urine ketones (UKET), urine leukocyte esterase test (ULET) for detecting WBC, urine nitrite (UNIT), urine occult blood (UOB) were performed with dipstick method. Urine microscopy (UM) is performed to detect bacteria (BAC), red blood cells (RBC) and white blood cells (WBC). Other urinalysis parameter included urine pH (UpH) and urine specific gravity (USG). Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0), Weeks 2 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Participants|||Number
2652899|NCT01648140|Primary|Mean Change From Baseline in Creatinine Clearance at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of Creatinine Clearance at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. It is estimated by Cockcroft-Gault Equation. Change from Baseline in the Creatinine Clearance values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Milliliter per minute (mL/min)||Standard Deviation|Mean
2652900|NCT01648140|Primary|Mean Change From Baseline in Chloride, Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus and Urea/Blood Urea Nitrogen (BUN) at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of Chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the chloride, bicarbonate, glucose, potassium, sodium, inorganic phosphorus and urea/BUN values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Millimoles per liter||Standard Deviation|Mean
2652901|NCT01648140|Primary|Mean Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of direct bilirubin, total bilirubin and creatinine at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the direct bilirubin, total bilirubin and creatinine values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Micromoles per liter||Standard Deviation|Mean
2652902|NCT01648140|Primary|Mean Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase (CK) and Gamma Glutamyl Transferase (GGT) at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of ALP, ALT, AST, CK and GGT at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4 Change from Baseline in the ALP, ALT, AST, CK and GGT values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||International units per liter||Standard Deviation|Mean
2657188|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 18|Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 18||||units on a scale||Standard Deviation|Mean
2652903|NCT01648140|Primary|Mean Change From Baseline in Albumin at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of albumin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the albumin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Grams per liter||Standard Deviation|Mean
2652904|NCT01648140|Primary|Mean Change From Baseline in Mean Corpuscle Volume at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of mean corpuscle volume at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the mean corpuscle volume values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Femtoliters||Standard Deviation|Mean
2652905|NCT01648140|Primary|Mean Change From Baseline in Hematocrit at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of hematocrit at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hematocrit values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population|||Ratio||Standard Deviation|Mean
2652906|NCT01648140|Primary|Mean Change From Baseline in Hemoglobin at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of hemoglobin at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Week 4. Change from Baseline in the hemoglobin values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Grams per liter||Standard Deviation|Mean
2652907|NCT01648140|Primary|Mean Change From Baseline in Red Blood Cell Count at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of red blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the red blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Trillion cells per liter||Standard Deviation|Mean
2652908|NCT01648140|Primary|Mean Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count at the Indicated Time Points up to Week 12|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count at the Baseline, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4. Change from Baseline in the basophils, eosinophils, lymphocytes, total neutrophils, platelet count and white blood cell count values are summarized for each post-Baseline assessment until Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Weeks 1, 2, 4, 6, 8 and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Giga cells per liter||Standard Deviation|Mean
2652909|NCT01648140|Primary|Mean Change From Baseline in Heart Rate at the Indicated Time Points up to Week 12|Vital sign monitoring included heart rate, measured at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and PT FU Weeks 4, 12 and 24. Change from Baseline in heart rate is summarized for each post-Baseline assessment upto Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) and Day 2, Weeks 1, 2, 4, 6, 8, and 12|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Beats per minute||Standard Deviation|Mean
2652937|NCT01647542|Secondary|Change From Baseline in 2-hour Postprandial Glucose (PPG) Following Oral Glucose Tolerance Test (OGTT) at Week 24|The change between the value of glucose after a meal, measured following OGTT collected at Week 24 relative to baseline. Oral glucose tolerance test measures glucose, insulin, and C-peptide through blood samples drawn at 0, 30, 60, 90, and 120 minutes following consumption of a 75 gram (g) glucose beverage.|Baseline and Week 24|FAS included of all randomized participants who received at least 1 dose of double blind study medication. Only participants with a baseline and at least 1 post-baseline value were included.|||mg/dL||Standard Error|Least Squares Mean
2652910|NCT01648140|Primary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points up to Week 12|Blood pressure measurements were taken to observe vital signs and included SBP and DBP at the Baseline, Day 2, Weeks 1, 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, 48 and Post-treatment (PT) Follow Up (FU) Weeks 4, 12 and 24. Change from Baseline in SBP and DBP is summarized for each post-Baseline assessment up to Week 12. Change from Baseline was calculated as the individual post-Baseline value minus the Baseline value. Baseline value is defined as the last Pre-treatment value observed.|Baseline (Week 0) up to 12-week treatment period|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the safety population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2652911|NCT01648140|Primary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) up to Week 12|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign(including an abnormal laboratory finding), symptom, or disease(new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, a congenital anomaly/birth defect, important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.|From the start of study treatment up to Week 12|Safety Population: comprised of all participants who received at least 1 dose of study medication (GSK2336805 or telaprevir).|||Participants|||Number
2652912|NCT01648140|Primary|Number of Participants Achieving eRVR|eRVR is defined as plasma HCV ribonucleic acid (RNA) <lower limit of quantification (LLOQ) and target not detected at Weeks 4 and 12. Participants who discontinued prior to Week 12 assessments or had missing HCV RNA values at Weeks 4 and 12 were treated as non-responders.|Week 4 and Week 12|Intent-To-Treat (ITT) Population: comprised of all participants who met the study criteria and were randomly assigned to treatment in the study with documented evidence of having received at least 1 dose of randomized treatment and at least 1 post Baseline HCV RNA measurement.|||Participants|||Number
2652913|NCT01648101|Secondary|Incidence of New Seizure Types During the TrP in Participants Without a History of the Indicated Seizure Types at Baseline|"A participant was considered to have new seizure types during the TrP if they experienced a new seizure types (such as SE, myoclonic, absence, secondary generalization) and had no prior history of these seizure types. At Screening, a history of previous seizure types was collected, with Yes, No, IS, SE, or Unknown being recorded for each of the seizures types. The history of seizure types was updated during the 8-week BP as pre-treatment status. New types of seizures during the TrP were recorded as A1=simple PS with motor signs; AX=simple PS without motor signs; B=complex PS; C=PS evolving to secondary generalized seizures; D1=absence of seizures; D2=myoclonic seizures; D3=clonic seizures; D4=tonic seizures; D5=tonic-clonic seizures; D6=atonic seizures; E=unclassified seizures; and SE=status epilepticus."|From Baseline up to Week 16|ITT Population.|||Number of events|||Number
2652914|NCT01648101|Secondary|Percentage of Seizure-free Days in the TrP|"The percentage of seizure-free days was calculated as: (total number of days without seizures in the TrP (TiP plus MP) / number of applicable days in the TrP) * 100. A seizure-free day is defined as a day with non-missing seizure data but without any seizures. A participant was considered to be seizure free during the TrP if he/she had no record of countable seizures of any type, no IS, and no SE during the TrP. Participants who had one or more days on which they recorded seizures as Not Done on the seizure calendar were not disqualified from being considered as seizure free for that day."|From Baseline up to Week 16|ITT Population.|||Percentage of seizure-free days||Standard Deviation|Mean
2652915|NCT01648101|Secondary|Percentage of Seizure-free Days in the MP|"The percentage of seizure-free days was calculated as: (total number of days without seizures in the MP / number of applicable days in the MP) * 100. A seizure-free day is defined as a day with non-missing seizure data but without any seizures. A participant was considered to be seizure free during the MP if he/she had no record of countable seizures of any type, no IS, and no SE during the MP. Participants who had one or more days on which they recorded seizures as Not Done on the seizure calendar were not disqualified from being considered as seizure free for that day."|From Week 4 up to Week 16|ITT Population.|||Percentage of seizure-free days||Standard Deviation|Mean
2652916|NCT01648101|Secondary|Number of Participants Who Were Seizure Free During the TrP|"A seizure free-day is defined as a day with non-missing seizure data but without any seizures. A participant was considered to be seizure free during the TrP if he/she had no record of countable seizures of any type, no IS, and no SE during the TrP. Participants who had one or more days on which they recorded seizures as Not Done on the seizure calendar were not disqualified from being considered as seizure free for that day. A participant was considered to be seizure free if they experienced no seizures in the TiP or MP regardless of how long they were in the study."|From Baseline up to Week 16|ITT Population.|||Participants|||Number
2652917|NCT01648101|Secondary|Number of Participants Who Were Seizure Free During the MP, ITT Population|"A seizure free-day is defined as a day with non-missing seizure data but without any seizures. A participant was considered to be seizure free during the MP if he/she had no record of countable seizures of any type, no IS, and no SE during the MP. Participants who had one or more days on which they recorded seizures as Not Done on the seizure calendar were not disqualified from being considered as seizure free for that day. Participants who did not complete the study or experienced any seizures in the MP were not considered to be seizure free. A participant who completed the study AND had no seizures during the maintenance phase were counted to be seizure free. Also, a completer who only had seizures during the TiP is considered seizure free."|Baseline; Week 4 up to Week 16|ITT Population.|||Participants|||Number
2652938|NCT01647542|Secondary|Change in Fasting Plasma Glucose From Baseline to Week 24|The change between the fasting plasma glucose value collected at Week 24 relative to baseline.|Baseline and Week 24|FAS included of all randomized participants who received at least 1 dose of double blind study medication. Only participants with a baseline and at least 1 post baseline value were included|||Milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
2652918|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the TrP Categorized as: >25% Increase and 0% to 25% Increase|"The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [TrP; TiP plus MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the TrP minus the start date of the TrP minus days on which seizures were recorded as Not Done during the TrP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (TrP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening."|From Baseline up to Week 16|ITT Population: Due to the early termination of the study, insufficient data are available to perform these analysis.||||||
2652919|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the MP Categorized as: >25% Increase and 0% to 25% Increase|"The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the MP minus the start date of the MP minus days on which seizures were recorded as Not Done during the MP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (MP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening."|Baseline; Week 4 up to Week 16|ITT Population: Due to the early termination of the study, insufficient data are available to perform these analysis.||||||
2652920|NCT01648101|Secondary|Percent Change From Baseline in 28 Day Total POS Frequency During the TrP Categorized as: no Change/Increase, >0% to <50% Decrease, 50% to 75% Decrease, and >75% to 100% Decrease|"The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [TrP; TiP plus MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the TrP minus the start date of the TrP minus days on which seizures were recorded as Not Done during the TrP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (TrP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening."|From Baseline up to Week 16|ITT Population: Due to the early termination of the study, insufficient data are available to perform these analysis.||||||
2652921|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the MP Categorized as: no Change/Increase, >0% to <50% Decrease, 50% to 75% Decrease, and >75% to 100% Decrease|"The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [MP] / number of applicable days in that period) * 28. In a case of >=1 occurrence of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the MP minus the start date of the MP minus days on which seizures were recorded as Not Done during the MP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (MP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline. There was no theoretical upper limit for worsening. Each occurrence of status epilepticus (SE) was counted as 1 seizure (whether partial status or not)."|Baseline; Week 4 up to Week 16|ITT Population: Due to the early termination of the study, insufficient data are available to perform these analysis.||||||
2652922|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the TrP|"The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [TrP; TiP plus MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the TrP minus the start date of the TrP minus days on which seizures were recorded as Not Done during the TrP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (TrP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening."|From Baseline up to Week 16|ITT Population. Participants who dropped out during the TiP were calculated based on TiP data. For all others both Titration and Maintenance Phase data were used|||Percent change||Full Range|Median
2652923|NCT01648101|Secondary|Percent Change From Baseline in the 28-day Total POS Frequency During the MP|"The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the MP minus the start date of the MP minus days on which seizures were recorded as Not Done during the MP plus 1. Percent change from Baseline was calculated as: ([the 28-day PS rate for the period of interest (MP) minus the Baseline 28-day PS rate] / Baseline 28-day PS rate) * 100. A negative percent change indicates a reduction (improvement) from Baseline; thus, the best possible outcome is -100% (100% reduction). There was no theoretical upper limit for worsening."|Baseline; Week 4 up to Week 16|ITT Population. Participants who dropped out during the TiP were calculated based on TiP data. For all others, only MP data were used.|||Percent change||Full Range|Median
2652924|NCT01648101|Secondary|Number of Responders From the BP to the Treatment Phase (TrP)|"A responder is defined as a participant experiencing a >=50% reduction in the 28-day total POS frequency from the BP to the TrP (TiP plus MP). The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [TrP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the TrP minus the start date of the TrP minus days on which seizures were recorded as Not Done during the TrP plus 1). Each occurrence of SE was counted as 1 seizure (whether partial status or not)."|From Baseline up to Week 16|Intent-to-Treat (ITT) Population|||Participants|||Number
2652925|NCT01648101|Secondary|Number of Placebo and Retigabine 600 mg Responders During the MP|"A responder is defined as a participant experiencing a >=50% reduction in the 28-day total POS frequency from the BP to the MP, randomly assigned to retigabine 600 mg/day compared to placebo. The 28-day total POS frequency was calculated as: (total number of PS over the time period of interest [MP] / number of applicable days in that period) * 28. In a case of one or more occurrences of IS on a day, these seizures were to be counted as an additional 10 seizures for that day, regardless of whether the IS were PS or not, and regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of the MP minus the start date of the MP minus days on which seizures were recorded as Not Done during the MP plus 1). Each occurrence of SE was counted as 1 seizure (whether partial status or not)."|Baseline; Week 4 up to Week 16|ITT Population: all par. who were randomly assigned to treatment; rec'd≥1 dose (or any portion of dose) of study medication; had BL sz data; and had ≥1 post-BL sz record (whether or not they had a sz) between start of TiP and end of MP. Par. who dropped out during TiP were classified as non-responders. For all other par. only MP data were used.|||Participants|||Number
2652926|NCT01648101|Primary|Number of Placebo and Retigabine 900 mg Responders During the Maintenance Phase (MP)|"A responder is defined as a par. with >=50% reduction in the 28 day total partial on-set seizure (POS) frequency from the Baseline Phase (BP) to the MP, randomly assigned to retigabine 900 mg/day compared with placebo. The total 28-day POS rate was defined as: (total number of POS over the evaluable period (MP) / number of days of seizure (sz) data in the evaluable period) *28 days. In the event of one or more innumerable seizures (IS) occurring on a day, these were to be counted as an additional 10 seizures for that day, regardless of the number of occurrences of IS on that day. The number of applicable days in a phase for seizure data is calculated as: the end date of MP minus start date of the MP minus days on which seizures were recorded as Not done + 1). Each occurrence of status epilepticus (SE) was counted as 1 seizure (whether partial or not)."|Baseline (BL); Week 4 up to Week 16|ITT Population: all par. who were randomly assigned to treatment; rec'd≥1 dose (or any portion of dose) of study medication; had BL sz data; and had ≥1 post-BL sz record (whether or not they had a sz) between start of TiP and end of MP. Par. who dropped out during TiP were classified as non-responders. For all other par. only MP data were used.|||Participants|||Number
2652927|NCT01647945|Secondary|Efficacy of Low-dose FK-506 in Pulmonary Arterial Hypertension (PAH) Measured by Change in 6-min Walk Distance (6MWD)|"Change in 6MWD in meter between baseline and 16 weeks~A large number would indicate an increase in exercise capacity"|baseline to 16 weeks|Only subjects were included who finished the 16-week study 3 patients did not finish|||meter||Inter-Quartile Range|Median
2652928|NCT01647945|Secondary|Number of Combined Clinical Events|"Combined Clinical Events @ 16 weeks:~Number of patients who died Number of patients who got transplanted Number of patients who needed escalation of therapies Number of patients who had worsening of NYHA/WHO classification by at least 1 point Number of patients who require hospitalization for right heart failure~Low numbers would suggest either efficacy of the study drug or slowly progression of disease that is studied during the 16 week study period or short observation period or small study population"|Baseline to 16 weeks|Subjects were included who finished the 16 week study period. A total of 3 participants did not complete the study|||Combined Number of Clinical Events|||Number
2652929|NCT01647945|Primary|Safety of Low-dose FK-506 in PAH|Total number of adverse events measured between baseline and end of study at 18 weeks as reported by study subjects such as nausea/diarrhea, URI, sinus congestion, infection, fluid retention/edema, cough, headache, bronchitis, fatigue, drug reaction/hives, flushing, anxiety, tremor, fever, shingles, SOB, insomnia, pain|18 weeks|all study subjects who started the study|||number of AEs|||Number
2652930|NCT01647737|Primary|Change in Salivary Flow From Baseline|Change in salivary flow in Xerostomic patients using Green tea lozenges|8 weeks|Enrolled subjects completing 8 weeks of treatment|||ml/min||Standard Deviation|Mean
2652931|NCT01647711|Primary|Maximum Tolerated Dose|Maximum Tolerated Dose (MTD) was defined as the dose in which less than 2 of up to 6 patients developed a Dose Limiting Toxicity (DLT).|28 days|Treated set including patients eligible for MTD determination|||mg|||Number
2652932|NCT01647711|Secondary|Determination of Dosage for Expansion Cohort in Part B|Determination of dosage for expansion cohort in Part B. Dosage was the MTD or less depending on tolerability.|28 days|Treated set including patients eligible for MTD determination|||mg|||Number
2652933|NCT01647711|Secondary|Cmax of Afatinib on Day 3 of Course 1|Maximum measured concentration (Cmax) of afatinib as determined on day 3 of course 1 for patients in Part A|47 hours (h) 55 minutes (min), 49h, 50h, 51h, 52h, 53h, 54h, 55h after first dose administration (on day 3 of course 1)|Pharmacokinetic set which included all patients treated in part A who were documented to have taken at least one dose of afatinib and who had in addition at least one valid afatinib concentration available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2652934|NCT01647711|Secondary|Objective Response Rate for Patients With EGFR T790M Mutations|"Objective response rate for patients with Epidermal Growth Factor Receptor (EGFR) T790M mutations. Objective response was defined as Complete Response (CR): Disappearance of all target lesion or Partial Response and (PR): >=30% decrease in the sum of the longest diameter of target lesions, according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.~This endpoint was originally planned to be analysed in part B of the study, however as no participants were treated in part B the analysis was performed on the part A participants."|From first drug administration until last drug administration, up to 420 days|Treated set including participants with EGFR T790M positive mutations|||Percentage of participants|||Number
2652940|NCT01647542|Primary|Change From Baseline in HbA1c at Week 24|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to baseline.|Baseline and Week 24|Full Analysis Set (FAS) included of all randomized participants who received at least 1 dose of double blind study medication. Only participants with a baseline and at least 1 post-baseline value were included.|||Percentage of Glycosylated Hemoglobin||Standard Error|Least Squares Mean
2652941|NCT01647464|Primary|Renal Video Intensity Units|Video intensity units in the kidney 10 min after completion of a clinically indicated contrast echocardiography study.|10 min||||units on a scale||Standard Deviation|Mean
2652942|NCT01647438|Primary|Change in Saturated Fat (% of Daily Kilo-calories From Fat) Intake|Change from baseline in saturated fat (% of daily kilo-calories from fat) intake measured by 24-hour food recall at 6-months|baseline and 6-months||||percentage of kilocalories||Standard Error|Mean
2652943|NCT01647438|Primary|Change in Physical Activity (Minutes/Week)|Change from baseline in minutes per week of physical activity measured by accelerometer at 6-months.|baseline and 6-months||||min/week||Standard Error|Mean
2652944|NCT01647282|Secondary|Inflammatory Biomarkers Found in Gingival Crevicular Fluid: IL-1.|The gingival crevicular fluid is analyzed biochemically and the levels of inflammatory biomarkers can be determined. Specific biomarkers are inherent in periodontal disease and have been shown to be indicative of periodontal breakdown within a pocket. In this study, the biomarker, IL-1 were assessed for their presence and quantity within the GCF samples taken from the experimental periodontal pockets at baseline and 24 months.|24 months|Patients included had moderate-severe chronic periodontitis with a >/= 5 mm interproximal, posterior pocket that bled upon probing. Participating patients had a history of regular periodontal maintenance therapy and no systemic disease (rheumatoid arthritis, osteoporosis, tetracycline allergy) or medications with bone-turnover significance.|||picograms/mL||Standard Deviation|Mean
2652945|NCT01647282|Primary|Change in Interproximal Bone Height Loss, Probing Depth and Clinical Attachment Level Over 24 Months|Changes in interproximal bone height loss were measured over the course of 24 months in two groups; patients receiving scaling and root planing alone in a deep periodontal pocket and those receiving scaling and root planing as well as minocycline microspheres in a deep periodontal pocket. These changes in interproximal bone height loss (mm) were determined via bitewing radiographs taken at baseline and 24 months and measured as distance from the cemento-enamel junction to the alveolar bone. Changes in probing depth (mm) were measured from the gingival margin to the depth of periodontal pocket. Changes in clinical attachment level (mm) were determined by adding the measure of gingival recession and the probing depth.|24 months|Patients included had moderate-severe chronic periodontitis with a >/= 5 mm interproximal, posterior pocket that bled upon probing. Participating patients had a history of regular periodontal maintenance therapy and no systemic disease (rheumatoid arthritis, osteoporosis, tetracycline allergy) or medications with bone-turnover significance.|||mm||Standard Deviation|Mean
2652946|NCT01647217|Secondary|Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia|Lid margin redness and bulbar conjunctival hyperemia were each assessed using an ordered categorical value ranging from 0 (None) to 3 (Severe). The two scores were summed to obtain the final score, which ranges from 0 (None) to 6 (Severe).|Baseline and 6 weeks||||units on a scale||Standard Deviation|Mean
2652947|NCT01647217|Primary|Change in the Number of Demodex Mites|"Change in mites count after treatment compared to the baseline data. If the mites' count remains zero during the last two visits, it is considered complete eradication. Patients without achieving complete eradication will be categorized as incomplete eradication."|6 weeks||||Mites||Standard Deviation|Mean
2652948|NCT01646827|Secondary|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.|This scale consists of a baseline evaluation that assesses the lifetime experience of the participant with suicide events and suicidal ideation and a post baseline evaluation that focuses on suicidality since the last trial visit.|Screening, Baseline, Week 1, Week 2, Week 8, Week 18 visit and Last visit.|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.|||Participants|||Number
2652949|NCT01646827|Secondary|Visual Analog Scale (VAS) Score at Day 1, Day 14, Day 28 and Last Visit.|Injection site pain was assessed using a VAS, which was completed by the trial participant, and the investigator's assessment of most recent injection site, which was completed by the investigator. VAS is 100 mm line, 0=no pain, 100=unbearably painful.|Day 1, Day 14, Day 28 and last visit|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.|||Units on a scale||Standard Deviation|Mean
2652950|NCT01646827|Secondary|Number of Participants With Electrocardiogram (ECG) Measurements of Potential Clinical Relevance|Three 12 lead ECGs were performed approximately 5 minutes apart at each time point. The participant were supine and at rest (for at least 10 minutes) prior to the first ECG and will remain supine through the final ECG. Based on criteria for identifying ECG measurements of potential clinical relevance, the abnormal values were noted. Some of the criteria are as follows: For bradycardia: ≤ 50 beats per minute (bpm); and for increase in QTc: QTc ≥ 450msec.|Day 1, Day 14, Day 28 and Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.|||Participants|||Number
2652951|NCT01646827|Secondary|Number of Participants With Vital Signs of Potential Clinical Relevance-Heart Rate|Vital sign assessment included heart rate (supine and standing). Heart rate with increase or decrease of >/= 15 beats per minute were recorded.|Day 1, Day 14, Day 28 and Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.|||Participants|||Number
2652952|NCT01646827|Secondary|Number of Participants With Vital Signs of Potential Clinical Relevance-Temperature|Vital sign assessment included body temperature measured in centigrade(C). Temperatures >=37.8°C and increase of >= 1.1°C were recorded.|Day 1, Day 14, Day 28 and Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.|||Participants|||Number
2653240|NCT01644474|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on­ or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2652953|NCT01646827|Secondary|Number of Participants With Vital Signs of Potential Clinical Relevance-Blood Pressure|Vital sign assessment included orthostatic (supine and standing) blood pressure. Orthostatic assessments were made after participants had been in the supine position for at least 5 minutes and again after participants had been standing for 2 minutes, but not more than 3 minutes. Orthostatic hypotension defined as >/= 20 mm Hg decrease in systolic blood pressure and >/= 25 beats per minute increase in heart rate from supine to standing.|Day 1, Day 14, Day 28 and Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.|||Participants|||Number
2652954|NCT01646827|Secondary|Number of Participants With Laboratory Values of Potential Clinical Relevance.|The laboratory tests were collected and processed in accordance with directions from the clinical chemistry laboratory. Based on criteria for identifying laboratory values of potential clinical relevance, the abnormal values were noted. Some of the criteria are as follows: For fasting triglycerides: men: ≥ 160 mg/dL and women: ≥ 120 mg/dL; Fasting glucose: ≥ 115 mg/dL; Prolactin: > upper limit of normal (ULN); Neutrophils: ≤ 1,500/mm3; and Creatine phosphokinase: ≥ 3 x ULN.|Day 1, Day 28, Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.|||Participants|||Number
2652955|NCT01646827|Secondary|Number of Participants Reporting Treatment Emergent Adverse Events (TEAE).|Safety was measured according to standard adverse event collection as described in the adverse event section of the results.|Starting at the time the ICF was signed to Day 126/Early termination|Population included all randomized participants who received at least one dose of drug, regardless of any protocol violation.|||Participants|||Number
2652956|NCT01646827|Primary|Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Dehydro-Aripiprazole|Relative bioavailability (Frel) of aripiprazole IM depot injected in the deltoid muscle compared to the gluteal muscle based on area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt), AUC time curve 28 and AUC from time zero to infinity PK parameters.|Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination|The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.|||ng day/mL||Standard Deviation|Mean
2652957|NCT01646827|Primary|Maximum Observed Plasma Concentration (Cmax) of Dehydro-Aripiprazole|Relative bioavailability (Frel) of aripiprazole intramuscular (IM) depot injected in the deltoid muscle compared to the gluteal muscle based on aripiprazole maximum (peak) plasma concentrations (Cmax) PK parameter.|Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination|The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.|||ng/mL||Standard Deviation|Mean
2652958|NCT01646827|Primary|Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Aripiprazole|Relative bioavailability (Frel) of aripiprazole IM depot injected in the deltoid muscle compared to the gluteal muscle based on area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt), AUC time curve 28, and AUC from time zero to infinity PK parameters.|Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination|The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.|||ng day/mL||Standard Deviation|Mean
2652959|NCT01646827|Primary|Maximum Observed Plasma Concentration (Cmax) of Aripriprazole|Relative bioavailability (Frel) of aripiprazole intramuscular (IM) depot injected in the deltoid muscle compared to the gluteal muscle based on aripiprazole maximum (peak) plasma concentrations (Cmax) PK parameter.|Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination|The dataset for the PK analysis consisted of all dosed subjects who had evaluable aripiprazole and dehydro-aripiprazole PK parameters.|||ng/mL||Standard Deviation|Mean
2652960|NCT01646814|Primary|Incidence of Gastroduodenal Ulcers|Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth|42 Days|Per protocol population (ie, Treated with ≥1 dose and Day 7 dose administered and endoscopy performed and ≥85% compliant)|||participants|||Number
2652961|NCT01646762|Secondary|Overall Response Rate|"Overall response rate (percentage) is defined as the percentage of patients with a partial response (PR) or better. A PR or better will be considered synonymous with success and is defined to be a stringent complete response (sCR = complete response (CR) + Normal serum FLC ratio + Absence of clonal cells in bone marrow), CR (= Negative immunofixation of the serum and urine + <5%plasma cells in bone marrow + Disappearance of any soft tissue plasmacytomas + normalization of FLC ratio), very good partial response (VGPR = PR + Serum and urine M-component detectable by immunofixation but not on electrophoresis ), or PR (≥ 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h) noted as the objective status. The percentage of successes (PR or better) will be estimated by the number of successes divided by the total number of evaluable patients times 100. PR or better will be evaluated using all cycles of treatment."|Up to 3 years||||percentage of patients||95% Confidence Interval|Number
2652962|NCT01646762|Secondary|Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|Toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event at least possibly related to the study treatment are reported below.|Up to 3 years||||percentage of patients|||Number
2657189|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 15|Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 15||||units on a scale||Standard Deviation|Mean
2652963|NCT01646762|Secondary|Duration of Response of All Evaluable Patients Who Have Achieved a Partial Response or Better|Duration of response is defined for all evaluable patients who have achieved a partial response or better (stringent complete response (sCR = complete response (CR) + Normal serum FLC ratio + Absence of clonal cells in bone marrow), CR (= Negative immunofixation of the serum and urine + <5%plasma cells in bone marrow + Disappearance of any soft tissue plasmacytomas + normalization of FLC ratio), very good partial response (VGPR = partial response (PR) + Serum and urine M-component detectable by immunofixation but not on electrophoresis ), or PR (≥ 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h) ) as the date at which the patients earliest best objective status is first noted to be at least a partial response or better to the earliest date of progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.|Date at which the patient's earliest best objective status is first noted to be at least a partial response or better to the earliest date progression is documented, assessed up to 3 years|All evaluable patients who have achieved a (unconfirmed or confirmed) partial response or better at the earliest best objective status are included in this analysis|||months||Full Range|Median
2652964|NCT01646762|Secondary|Progression Free Survival at 3 Months|"The distribution of time to progression will be estimated using the method of Kaplan-Meier and the 3 month progression-free rate (percentage) will be provided. Progression is defined as:~Any one or more of the following: Increase of 25% from lowest value in:~Serum M-component (absolute increase must be ≥ 0.5 g/dl~Serum M-component increase ≥ 1 g/dl, if lowest M component was ≥ 5 g/dl~Urine M-component (absolute increase must be ≥ 200 mg/24 h)~If at on study, the only measurable non-bone marrow parameter was free light chain (FLC), the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dl)~Bone marrow plasma cell percentage (absolute % must be ≥10%) Or any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder~Development of new soft tissue plasmacytomas or bone lesions~Hypercalcemia (≥11.5 mg/dl)~Decrease in hemoglobin of ≥2 g/dl~Serum creatinine level ≥2 mg/dl"|Time from registration to the earliest date of documentation of disease progression, assessed up to 3 years||||percentage of patients|||Number
2652965|NCT01646762|Secondary|Survival Time|Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.|Time from registration to death due to any cause, assessed up to 3 years||||months||95% Confidence Interval|Median
2652966|NCT01646762|Primary|Percentage of Patients Who Have a Confirmed Partial Response or Better|"A confirmed partial response or better will be considered synonymous with success and is defined to be a stringent complete response (sCR = complete response (CR) + Normal serum FLC ratio + Absence of clonal cells in bone marrow), CR (= Negative immunofixation of the serum and urine + <5%plasma cells in bone marrow + Disappearance of any soft tissue plasmacytomas + normalization of FLC ratio), very good partial response (VGPR = partial response (PR) + Serum and urine M-component detectable by immunofixation but not on electrophoresis ), or PR (≥ 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥ 90% or to <200 mg per 24 h) noted as the objective status on two consecutive evaluations. The percentage of successes (confirmed PR or better) will be estimated by the number of successes divided by the total number of evaluable patients times 100. Confirmed PR or better will be evaluated using all cycles of treatment."|Up to 3 years||||percentage of patients||95% Confidence Interval|Number
2652967|NCT01646671|Secondary|Percentage of Participants With DBP Response at End of Study|DBP response was defined as <90 mmHg or a reduction ≥ 10 mmHg from baseline.|Baseline, 8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.|||Percentage of Participants|||Number
2652968|NCT01646671|Secondary|Percentage of Participants With SBP Response at End of Study|SBP response was defined as <140 mmHg or a reduction ≥ 20 mmHg from baseline.|Baseline, 8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.|||Percentage of Participants|||Number
2652969|NCT01646671|Secondary|Percentage of Participants Achieving Successful msDBP Control at End of Study|Successful msDBP control in patients with severe hypertension at the end of study treatment was defined as msDBP < 90 mmHg.|8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.|||Percentage of Participants|||Number
2652970|NCT01646671|Secondary|Percentage of Participants Achieving Successful msSBP Control at End of Study|Successful msSBP control in patients with severe hypertension at the end of study treatment was defined as msSBP <140 mmHg.|8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.|||Percentage of Participants|||Number
2652971|NCT01646671|Secondary|Percentage of Participants With Successful Blood Pressure (BP) Control in msSBP/msDBP at End of Study|Successful BP control in patients with severe hypertension at the end of study treatment was defined as follows: msSBP/msDBP< 140/90 mmHg.|8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.|||Percentage of Participants|||Number
2652972|NCT01646671|Secondary|Change From Baseline in msSBP and msDBP at Week 8|Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP measurements were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline value.|Baseline, 8 weeks|Full Analysis Set: included all patients who entered the treatment epoch. This set was determined by the maximum treatment patients received, i.e. combination of the highest LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication during the treatment epoch.|||mmHg||Standard Deviation|Mean
2652973|NCT01646671|Primary|Percentage of Participants With Adverse Events (AEs), Serious Adverse Events and Deaths|Adverse events, serious adverse events deaths were monitored from screening to week 8.|Week 8|AE analysis was determined by actual treatment, i.e. the LCZ696 dose and use of newly introduced anti-HTN medication/dose escalation of base anti-HTN medication on the day in which the corresponding summary was targeting. Participants could be counted in more than one category. Other safety analysis was determined by the maximum treatment.|||Percentage of participants|||Number
2652974|NCT01646398|Other Pre-specified|Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination|Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (>=) 37.5 degrees Celsius [C], fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, aggravated muscle pain, new joint pain, aggravated joint pain, use of medication to treat fever and use of medication to treat pain. All reports of fever >=39 degrees C in 13vPnC and 23vPS were confirmed as data entry errors.|Within 14 days after vaccination|Safety population included all participants who received the study vaccine. 'N' (number of participants analyzed)=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
2652975|NCT01646398|Other Pre-specified|Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination|Local reactions reported using an electronic diary. Redness and swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters [cm]; Moderate (5.1 to 10.0 cm); Severe (>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).|Within 14 days after vaccination|Safety population included all participants who received the study vaccine. 'N' (number of participants analyzed)=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.|||percentage of participants||95% Confidence Interval|Number
2652976|NCT01646398|Secondary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination|Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolonoy OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|One month after vaccination|Evaluable immunogenicity population:eligible participants, received study vaccine to which randomized, received no prohibited vaccines, had at least 1 valid and determinate assay result, had blood drawn within prescribed time frame and had no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.|||titer||95% Confidence Interval|Geometric Mean
2652977|NCT01646398|Primary|Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination|For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.|One month after vaccination|Evaluable immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with determinate fold rise of OPA antibody titer to serotype 6A.|||percentage of participants||95% Confidence Interval|Number
2652978|NCT01646398|Primary|Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination|Antibody-mediated serum OPA against each of the 12 pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|One month after vaccination|Evaluable immunogenicity population:eligible participants, received study vaccine to which randomized, received no prohibited vaccines, had at least 1 valid and determinate assay result, had blood drawn within prescribed time frame and had no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.|||titer||95% Confidence Interval|Geometric Mean
2652979|NCT01646385|Secondary|Health Assessment Questionnaire (HAQ) Score 6 Months Prior to And 6 Months Post-Switching Etanercept|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|6 months prior to and 6 months post switching etanercept|FAS population. Here “N” (number of participants analyzed): participants evaluable for this measure, “n”: participants evaluable for specified time-points. Only participants treated with ETN were to be analyzed for this outcome measure.|||units on a scale||Standard Deviation|Mean
2652980|NCT01646385|Secondary|Percentage of Participants With Remission Based on Health Assessment Questionnaire (HAQ) Score|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3. Participants who had HAQ total score <=0.5 were considered in remission state.|Year 1, 2, 3|FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.|||percentage of participants|||Number
2657190|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 11|Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 11||||units on a scale||Standard Deviation|Mean
2652981|NCT01646385|Secondary|Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Year 1, 2, and 3|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|Baseline, Year 1, 2, 3|FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.|||units on a scale||95% Confidence Interval|Least Squares Mean
2652982|NCT01646385|Secondary|Health Assessment Questionnaire (HAQ) Score at Baseline|HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|Baseline|FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.|||units on a scale||Standard Deviation|Mean
2652983|NCT01646385|Secondary|Time to Remission|DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity. Time to achieve remission was calculated by Kaplan-Meier survival analysis.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.|||years||95% Confidence Interval|Median
2652984|NCT01646385|Secondary|Percentage of Participants With Remission and Low Disease Activity as Assessed by Disease Activity Score Based on 28-Joints Count (DAS28)|DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity.|Year 1, 2, 3, 4, 5|FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.|||percentage of participants|||Number
2652985|NCT01646385|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Year 1, 2, 3, 4, and 5|DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR [millimeter per hour] or CRP [milligram per liter]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity.|Baseline, Year 1, 2, 3, 4, 5|FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.|||units on a scale||95% Confidence Interval|Least Squares Mean
2652986|NCT01646385|Secondary|Disease Activity Score Based on 28-Joints Count (DAS28) at Baseline|DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the serological markers of inflammation (erythrocyte sedimentation rate [ESR, millimeter per hour] or C-reactive protein [CRP, milligram per liter]) and patient's general health assessment (recorded on a Visual Analog Scale [VAS] of 0 millimeter [mm]-100 mm). DAS28 <=1.6 = remission, DAS28 <=2.4 = low disease activity, DAS28 >=3.2 to 5.1 = moderate disease activity, DAS28 >5.1 = severe disease activity.|Baseline|FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.|||units on a scale||Standard Deviation|Mean
2652987|NCT01646385|Secondary|Time on Etanercept Therapy|Time on etanercept therapy was calculated by Kaplan-Meier survival analysis.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. Only participants treated with ETN were to be analyzed for this outcome measure.|||years||95% Confidence Interval|Median
2652988|NCT01646385|Secondary|Percentage of Participants Who Switched to Other Therapy Following Etanercept Discontinuation|Participants who switched from etanercept to either DMARDs or alternative biologic drug are reported.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Full Analysis set (FAS) population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. Only participants treated with ETN were to be analyzed for this outcome measure.|||percentage of participants|||Number
2653001|NCT01646320|Secondary|Percentage of Subjects Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Percent adjusted for baseline HbA1c. Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis.|From baseline to week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period|||Percentage of subjects|||Number
2652989|NCT01646385|Primary|Crude Incidence Rate of All-Cause Mortality|Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of deaths divided by Participant-Year, multiplied by 1000. Death was recorded in the adverse outcomes table and in the consultant follow-up table. Where multiple events described death for the same participant, date of death was taken as per the earliest record.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.|||events per 1000 participant-years|||Number
2652990|NCT01646385|Primary|Crude Incidence Rate of Other Serious Adverse Events|Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of other serious adverse events divided by Participant-Year, multiplied by 1000. Other serious adverse events were based on classifications assigned by the BSRBR and included cardiac serious adverse events (SAEs), central nervous system SAEs, and nonmalignant hematological SAEs.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.|||events per 1000 participant-years|||Number
2652991|NCT01646385|Primary|Crude Incidence Rate of Serious Infections|Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of serious infections divided by Participant-Year, multiplied by 1000. Serious infections included those infections which required intravenous antibiotics, hospitalization, or resulted in death. Adverse outcome was defined as 'serious infection' in the field [serinf] labeled by BSRBR.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.|||events per 1000 participant-years|||Number
2652992|NCT01646385|Primary|Crude Incidence Rate of Lymphoproliferative Malignancy (LM)|Participant-Year estimated by calculating all of years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of LMs divided by Participant-Year, multiplied by 1000. Lymphoproliferative: medical condition characterized by the dysfunction of the immune system often resulting in excessive production of lymphocytes. LMs included lymphoma, myeloma, and leukemia. Adverse outcome was defined as 'lymphoproliferative malignancy' in the field [lymphopro] labeled by BSRBR.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.|||events per 1000 participant-years|||Number
2652993|NCT01646385|Primary|Crude Incidence Rate of Malignancy|Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of malignancy events divided by Participant-Year, multiplied by 1000.|Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years|Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.|||events per 1000 participant-years|||Number
2652994|NCT01646346|Secondary|Cosmesis by Medical Doctor Report|Medical doctor will be provided with cosmesis scale and grade cosmesis of breast. Cosmesis was based on the Harvard Cosmesis Scale rated as :1. excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae.|3 yr post treatment||||Participants|||Count of Participants
2652995|NCT01646346|Secondary|Cosmesis by Medical Doctor Report|Medical doctor will be provided with cosmesis scale and grade cosmesis of breast. Cosmesis was based on the Harvard Cosmesis Scale rated as :1. excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae.|1 yr post treatment||||Participants|||Count of Participants
2652996|NCT01646346|Secondary|Cosmesis by Medical Doctor Report|Medical doctor will be provided with cosmesis scale and grade cosmesis of breast. Cosmesis was based on the Harvard Cosmesis Scale rated as :1. excellent: the treated breast looked essentially the same as the opposite breast; 2. good: minimal but identifiable effects of radiation on the treated breast; 3. fair: significant effects of radiation on the breast were noted; 4. severe normal tissue sequelae.|Within no more than 8 weeks of surgery, but prior to the start of radiation||||Participants|||Count of Participants
2652997|NCT01646346|Secondary|Cosmesis by Patient Report|This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS). Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome). Scores on each item are summed to obtain a total score.|3 year post treatment||||units on a scale||Full Range|Median
2652998|NCT01646346|Secondary|Cosmesis by Patient Report|This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS). Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome). Scores on each item are summed to obtain a total score.|1 year post treatment||||units on a scale||Full Range|Median
2652999|NCT01646346|Secondary|Cosmesis by Patient Report|This outcome is measured by the Breast Cancer Treatment outcome Scale (BCTOS). Eleven items (e.g., breast size, breast pain, breast shape) are rated by patients on a 4-point scale (0=no difference to 3=large difference), with a score range of 0-33 (higher scores signifying worse outcome). Scores on each item are summed to obtain a total score.|Within no more than 8 weeks of surgery, but prior to the start of radiation||||units on a scale||Full Range|Median
2653002|NCT01646320|Secondary|Adjusted Mean Change From Baseline in Body Weight at Week 24|Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weights were measured during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period.|From baseline to Week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period|||kg||Standard Error|Least Squares Mean
2653003|NCT01646320|Secondary|Adjusted Mean Change From Baseline in 120-minute Postprandial Glucose (PPG) at Week 24|2-hour postprandial glucose (PPG) from a liquid meal tolerance test (2-h MTT) Subject must be fasted for at least 8 hrs prior to the MTT.|From Baseline to Week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period. Number of participants analyzed is the number of randomized subjects with non-missing baseline and Week 24 (LOCF) values.|||mg/dL||Standard Error|Least Squares Mean
2653004|NCT01646320|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24|Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period|From Baseline to Week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period. Number of participants analyzed corresponds to the number of randomized subjects with non-missing baseline value and at least one post-baseline value.|||mg/dL||Standard Error|Least Squares Mean
2653005|NCT01646320|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24|HbA1c was measured as percent of hemoglobin by a central laboratory. Data after rescue medication was excluded from this analysis. Baseline was defined as the last assessment prior to the start date and time of the first dose of the double-blind study medication. In cases where time of the first dose or time of the assessment was not available, baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained during the qualification and lead-in periods and on Day 1 and Weeks 6, 12, 18, and 24 in the double-blind period.|From Baseline to Week 24|The Randomized Subjects Data Set consists of all randomized subjects who received at least one dose of double-blind study medication during the double-blind treatment period.|||Percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2653006|NCT01646268|Secondary|Change in Unified Parkinson's Disease Rating Scale [UPDRS Part III (Motor Examination)] From Baseline to the End of the Double-blind Maintenance Period|"The UPDRS assessments (Parts II+III) will be performed at every visit.~For the assessment of the subject's motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the on state.~The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score ranges from 0 to 108, higher scores denote greater disability."|From Baseline (Week 0) to end of Maintenance Period (up to Week 24)|This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
2653007|NCT01646268|Secondary|Change in Unified Parkinson's Disease Rating Scale [UPDRS Part II (ADL)] From Baseline to the End of the Double-blind Maintenance Period|"The UPDRS assessments (Parts II+III) will be performed at every visit.~For the assessment of the subject's disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject's disease state in the on state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The sum score ranges from 0 to 52, higher scores denote greater disability."|From Baseline (Week 0) to end of Maintenance Period (up to Week 24)|This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
2653008|NCT01646268|Secondary|Response to Therapy, Defined as ≥20 % Decrease in the Sum of Scores From Activities of Daily Living (ADL) & Motor Examination in Unified Parkinson's Disease Rating Scale (UPDRS Parts II+III, a UPDRS Subtotal) From Baseline to End of Maintenance Period|"The UPDRS assessments (Parts II+III) will be performed at every visit. For the assessment of the subject's disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject's disease state in the on state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). For the assessment of the subject's motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the on state.~The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score is calculated as sum of these 27 individual scores. A higher score denotes greater disability."|From Baseline (Week 0) to end of Maintenance Period (up to Week 24)|This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.|||percentage of responders|||Number
2653026|NCT01646203|Secondary|Pharmacokinetics - Minimum Concentration (Cmin) of IMC-TR1|Pharmacokinetics - Minimum concentration (Cmin) of IMC-TR1|Cycle 2 Day 1: Prior to fourth infusion 0 hour (h)|All participants who received at least one dose of study drug and had evaluable PK data. PK of LY3022859 was not characterized at the 1.25 mg/kg dose level because of infusion interruptions thus no data collected.|||microgram/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2653009|NCT01646268|Primary|Change in the Sum of the Score From the Activities of Daily Living (ADL) Scale and Motor Examination in the Unified Parkinson's Disease Rating Scale (UPDRS) (Parts II+III, a UPDRS Subtotal) From Baseline to the End of Double-blind Maintenance Period|"The UPDRS assessments (Parts II+III) will be performed at every visit.~For the assessment of the subject's disability, Part II of the UPDRS will be used. Data will be gathered pertaining to the subject's disease state in the on state. Subjects will respond to questions about their general state in the week prior to their scheduled visit in conjunction with any observations made by the investigator (or designee). For the assessment of the subject's motor function, Part III of the UPDRS will be used and the assessments will be done while the subject is in the on state.~The UPDRS Part II (Activities of Daily Living) consists of 13 items scored between 0 and 4. The UPDRS Part III (motor subscale) consists of 27 items and sub items scored between 0 and 4. The sum score is calculated as sum of these 27 individual scores. The sum score ranges from 0 to 160, higher scores denote greater disability."|From Baseline (Week 0) to end of Maintenance Period (up to Week 24)|This analysis consists of the Full Analysis Set [Last Observation Carried Forward], which includes all subjects who are randomized, receive at least 1 dose of study medication, and have a Baseline efficacy measurement and at least 1 post-Baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
2653010|NCT01646255|Secondary|"Change in Unified Parkinson's Disease Rating Scale (UPDRS Part III Motor Examination) During on Periods From Baseline to the End of Double-blind Maintenance Period"|"The UPDRS Part III (motor subscale) assessment consists of 27 questions, measured on a 5-Point scale (0 to 4). The sum score is calculated as sum of these 27 individual questions. This score ranges from 0 to 108, higher scores denote greater disability.~A subject has been considered on when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||units on a scale||Standard Deviation|Mean
2653011|NCT01646255|Secondary|Change in Status of the Subject (Off) After Wake-up From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered off when he/she began to lose the optimum effects of anti-Parkinson's medication.~The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the off state is presented below."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||percentage of days||Standard Deviation|Mean
2653012|NCT01646255|Secondary|Change in Status of the Subject (on) After Wake-up Without Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered on when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.~The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the on without troublesome dyskinesia state is presented below."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||percentage of days||Standard Deviation|Mean
2653013|NCT01646255|Secondary|Change in Status of the Subject (on) After Wake-up With Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered on when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.~The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the on with troublesome dyskinesia state is presented below."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||percentage of days||Standard Deviation|Mean
2653014|NCT01646255|Secondary|"Change in the Number of Off Periods From Baseline to the End of Double-blind Maintenance Period"|"A subject has been considered off when he/she began to lose the optimum effects of anti-Parkinson's medication."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||Number of 'off' Periods||Standard Deviation|Mean
2653015|NCT01646255|Secondary|"Percent Change in Relative Time Spent on From Baseline to the End of Double-blind Maintenance Period"|"A subject has been considered on when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was off when taking his/her L-dopa, he/she recorded the exact time their status changed to on.~Note for percent change calculations: when relative time at Baseline was 0%, the relative Baseline value was assumed to be 0.1 for calculation purposes.~Relative time spent on will be calculated in two stages. Each valid daily diary will have an associated relative time on calculated as relative time on for day = 100*[total absolute time on for day/ absolute time awake for day]. Relative time spent on is then calculated by averaging the daily relative time on for the valid days of that visit."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||percent change||Standard Deviation|Mean
2653472|NCT01643772|Primary|Tmax,t1/2 for Participants Who Received a Single Dose|To calculate Tmax,t1/2 of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.|blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.|PP popluation|||hour||Standard Deviation|Mean
2653016|NCT01646255|Secondary|"Percent Change in Absolute Time Spent on From Baseline to the End of Double-blind Maintenance Period"|"A subject has been considered on when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.~Note for percent change calculations: when absolute time at Baseline was 0 hours, the absolute Baseline value was assumed to be 1 minute for calculation purposes."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||percent change||Standard Deviation|Mean
2653017|NCT01646255|Secondary|"Change in Relative Time Spent on From Baseline to the End of Double-blind Maintenance Period"|"A subject has been considered on when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was off when taking his/her L-dopa, he/she recorded the exact time their status changed to on.~Relative time spent on will be calculated in two stages. Each valid daily diary will have an associated relative time on calculated as relative time on for day = 100*[total absolute time on for day/ absolute time awake for day]. Relative time spent on is then calculated by averaging the daily relative time on for the valid days of that visit."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||hours||Standard Deviation|Mean
2653018|NCT01646255|Secondary|"Change in Absolute Time Spent on From Baseline to the End of Double-blind Maintenance Period"|"A subject has been considered on when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'.~Absolute time on is defined as the mean number of hours marked on during a 24-hour period from all valid daily diary cards."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||hours||Standard Deviation|Mean
2653019|NCT01646255|Secondary|"Percent Change in Relative Time Spent Off From Baseline to the End of Double-blind Maintenance Period"|"A subject has been considered off when he/she began to lose the optimum effects of anti-Parkinson's medication.~Relative time spent off will be calculated in two stages. Each valid daily diary will have an associated relative time off calculated as relative time off for day = 100*[total absolute time off for day/ absolute time awake for day]. Relative time spent off is then calculated by averaging the daily relative time off for the valid days of that visit."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||percent change||Standard Deviation|Mean
2653020|NCT01646255|Secondary|"Percent Change in Absolute Time Spent Off From Baseline to the End of Double-blind Maintenance Period"|"A subject has been considered off when he/she began to lose the optimum effects of anti-Parkinson's medication.~Absolute time off is defined as the mean number of hours marked off during a 24-hour period from all valid daily diary cards."|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||percent change||Standard Deviation|Mean
2653021|NCT01646255|Secondary|Percentage of Responders From Baseline to the End of the Doubleblind Maintenance Period|A Responder is defined as a subject with an ≥ 30 % decrease in absolute time spent 'off'|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||percentage of participants|||Number
2653022|NCT01646255|Primary|Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period|"A subject has been considered off when he/she began to lose the optimum effects of anti-Parkinson's medication. A negative mean indicates a reduction of the time off during the conduct of the study"|From Baseline (Week 0) to end of Maintenance Period (up to Week 12)|The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement.|||hours||Standard Deviation|Mean
2653023|NCT01646216|Secondary|Walking Speed|Subjects walked on an electronic walkway and walking speed was calculated by total distance divided by total time.|Baseline, post training, and 3 month follow up.|All subjects for whom walk speed was recorded at baseline, post training, and follow up.|||meters per second (m/s)||Standard Deviation|Mean
2653024|NCT01646216|Secondary|Change in Baseline Oxygen Intake|This is the change in metabolic power that is required of a subject to walk at their self selected walking speed on the treadmill. Metabolic power was measured at baseline, post training, and three months after training. We report the difference between post training and baseline and three months and baseline.|Post training (week 14), and 3 months follow up|"One subject in the Split-belt Severe Disability Arm/Group did not complete the assessment during the change at follow up visit. Two subjects in the Tied-belt, Severe Disability Arm/Group were not able to complete the assessments at post training or follow up."|||ml/kg/min||Full Range|Mean
2653025|NCT01646216|Primary|Change in Baseline Step Length Symmetry. That is, Whether the Steps With Right and Left Legs Are the Same Length.|Subjects will either walk on a special mat that records their step lengths, or will wear special markers on the feet and body to record their step lengths.|After training (week 14), and 3 months after training|Subjects were grouped by baseline walking speed into three levels of disability: mild, moderate, and severe.|||ratio||Full Range|Mean
2653027|NCT01646203|Secondary|Pharmacokinetics - Maximum Concentration (Cmax) of IMC-TR1||Cycle (C) 1 Day (D) 1: 1, 2, 4, 8 hours (h); C1 D2: 24 h; C1 D3: 48 h; C1 D5: 96 h; C1 D8: 168 h; C1 D15: 336 h; C2 D15: 1, 2, 4, 8 h; C2 D16: 24 h; C2 D17: 48 h; C2 D19: 96 h; C2 D22: 168 h, C2 D29: 336 h|All participants who received at least one dose of study drug and had evaluable PK data. PK of LY3022859 was not characterized at the 1.25 mg/kg dose level because of infusion interruptions thus no data collected.|||microgram per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2653028|NCT01646203|Secondary|Pharmacokinetics (PK) - Area Under the Concentration-time Curve (AUC[0-tlast]) and AUCτ of IMC-TR1|"AUC (0-tlast) is area under the concentration versus time curve from the time zero to tlast.~AUCτ is area under the concentration versus time curve during 1 dose interval (336 hours)."|Cycle (C) 1 Day (D) 1: 1, 2, 4, 8 hours (h); C1 D2: 24 h; C1 D3: 48 h; C1 D5: 96 h; C1 D8: 168 h; C1 D15: 336 h; C2 D15: 1, 2, 4, 8 h; C2 D16: 24 h; C2 D17: 48 h; C2 D19: 96 h; C2 D22: 168 h, C2 D29: 336 h|All participants who received at least one dose of study drug and had evaluable PK data. PK of LY3022859 was not characterized at the 1.25-mg/kg dose level because of infusion interruptions thus no data collected.|||microgram*hour per milliliter(µg·hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2653029|NCT01646203|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) (Antitumor Activity of IMC-TR1 as Monotherapy, Assessed Via Tumor Measurement by Response Evaluation Criteria in Solid Tumors, Version 1.1)|ORR is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|First Dose to Measured Progressive Disease (Up To 21.3 Weeks)|All participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2653030|NCT01646203|Secondary|Immunogenicity - Development of Antibodies Against IMC-TR1||Cycle 1 - Day 1 and Day 29, Cycle 2 - Day 15, Cycle 3 and Each Consecutive Cycle - Day 1|Zero participants were analyzed. Immunogenicity data were not collected.||||||
2653031|NCT01646203|Secondary|Number of Dose-Limiting Toxicities (DLTs)||First Dose through Cycle 1 (6 Weeks)|All participants who received at least one dose of study drug.|||DLTs|||Number
2653032|NCT01646203|Secondary|Maximum Tolerated Dose (MTD) of IMC-TR1 (1.25 mg/kg LY3022859 ) for Participants Receiving a Weight-Based Dose|The MTD was defined as the highest dose level at which ≤33% of participants experienced a DLT during Cycle 1.|First Dose through Cycle 1 (6 Weeks)|All participants who received at least one dose of study drug and completed cycle 1 or discontinued treatment due to a DLT during the cycle 1.|||milligram/kilogram (mg/kg)|||Number
2653033|NCT01646203|Secondary|Maximum Tolerated Dose (MTD) of IMC-TR1|The MTD was defined as the highest dose level at which ≤33% of participants experienced a DLT during Cycle 1.|First Dose through Cycle 1 (6 Weeks)|All participants who received at least one dose of study drug and completed cycle 1 or discontinued treatment due to a DLT during the cycle 1.|||milligram (mg)|||Number
2653034|NCT01646203|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|A DLT was defined as an AE occurring during Cycle 1(first 6 weeks of treatment) that was considered at least possibly related to study drug, was considered dose-dependent, and fulfilled a criteria selected (using the National Cancer Institute Common Terminology Criteria for Adverse Events,version 4.0 [NCI-CTCAE v 4.0] [NCI 2009]):Grade(Gr)≥3 nonhematological toxicity,Gr4 thrombocytopenia lasting at least 5 days and/or complicated with bleeding,Gr≥3 febrile neutropenia(ntr),Gr4 ntr of >5 days' duration,increase(incr)of at least 1 gr from a preexisting Gr1 valvular insufficiency or any new Gr≥2 valvular toxicity,left ventricular(vtr) ejection fraction decrease of 10% in absolute value or 16% in relative value,incr in right vtr systolic pressure dysfunction from mild to moderate(mod) or from mod to severe,incr in left atrial or ventricular chamber size of ≥2 cm and ≥1cm respectively,any other life-threatening toxicity,significant morphologic on cardiac echocardiogram,any major ocular.|First Dose Up to 6 Weeks|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2653035|NCT01646177|Secondary|Number of Participants With Treatment-Emergent Anti-Ixekizumab Antibodies|The percentage of participants with treatment-emergent positive anti-ixekizumab antibodies at any time post-baseline were summarized by treatment group. Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies were calculated as: number of participants with an evaluable baseline sample and ≥1 evaluable post-baseline sample/number of participants in the analysis population * 100.|Baseline, Week 12|All randomized participants who received at least one dose of study treatment and had evaluable data.|||Participants|||Number
2653036|NCT01646177|Secondary|Number of Participants Achieving Palmoplantar PASI of 100% (PPASI 100) Improvement|Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. Participants achieving PPASI 100 were defined as having an improvement of 100% in the PPASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, or did not follow the protocol, and had a diagnosis of palmoplantar psoriasis at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.|||Participants|||Number
2653037|NCT01646177|Secondary|Number of Participants Achieving Palmoplantar PASI of ≥75% (PPASI 75) Improvement|Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. Participants achieving PPASI 75 were defined as having an improvement of at least 75% in the PPASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, or did not follow the protocol, and had a diagnosis of palmoplantar psoriasis at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.|||Participants|||Number
2653473|NCT01643772|Primary|Cmax,Clast for Participants Who Received a Single Dose|To calculate Cmax,Clast of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.|blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.|PP population|||ng*mL||Standard Deviation|Mean
2653038|NCT01646177|Secondary|Number of Participants Achieving Palmoplantar PASI of ≥50% (PPASI 50) Improvement|Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. Participants achieving PPASI 50 were defined as having an improvement of at least 50% in the PPASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, or did not follow the protocol, and had a diagnosis of palmoplantar psoriasis at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.|||Participants|||Number
2653039|NCT01646177|Secondary|Change From Baseline in Patient's Global Assessment of Disease Severity|"The Patient's Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis today from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. LS Means in Patient's Global Assessment of Disease Severity score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects."|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of Patient's Global Assessment of Disease Severity.|||Units on a Scale||Standard Error|Least Squares Mean
2653040|NCT01646177|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short Form (SF-36) Health Survey, Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores|The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS Means in SF-36 score were calculated using the ANCOVA model with treatment, pooled center and baseline SF-36 score.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of SF-36. Participants with missing SF-36 data were imputed by Last Observation Carried Forward (LOCF) method.|||Units on a Scale||Standard Error|Least Squares Mean
2653041|NCT01646177|Secondary|Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO)|The WPAI-PSO is a 6-item instrument used to assess the impact of psoriasis on productivity impairment within the past 7 days. It has four domains: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score, and impairment in daily activities performed outside of work. Four scores are derived as percentages: absenteeism, presenteeism, overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as: each score * 100 and ranged from 0 to 100. Higher scores indicate greater impairment in productivity. LS Means in each WPAI-PSO score were calculated using the ANCOVA model with treatment, pooled center and baseline WPAI-PSO score.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of WPAI-PSO. Participants with missing WPAI-PSO data were imputed by Last Observation Carried Forward (LOCF) method.|||Units on a Scale||Standard Error|Least Squares Mean
2653042|NCT01646177|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]|The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance [initial, middle and late insomnia or hypersomnia], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS Means in total QIDS-SR16 score were calculated using the analysis of covariance (ANCOVA) model with treatment, pooled center and baseline QIDS total score.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of QIDS-SR16. Participants with missing QIDS-SR16 data were imputed by Last Observation Carried Forward (LOCF) method.|||Units on a Scale||Standard Error|Least Squares Mean
2653043|NCT01646177|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score|PSSI is a composite score ranging from 0 (best) to 72 (worst), derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. LS Means in PSSI score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, who had scalp psoriasis at baseline and had at least one post-dose measurement of PSSI.|||Units on a Scale||Standard Error|Least Squares Mean
2653044|NCT01646177|Secondary|Percent of Body Surface Area (BSA) Involvement of Psoriasis|Percentage involvement of psoriasis on each participants body surface area was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including palm, fingers and thumb). LS Means in BSA were calculated using MMRM with baseline BSA as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of BSA.|||Percent||Standard Error|Least Squares Mean
2653241|NCT01644474|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2653045|NCT01646177|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI is a numeric, reproducible, objective tool used to evaluate the severity of fingernail bed psoriasis and fingernail matrix psoriasis by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed psoriasis: 0 (none) to 4 (psoriasis in 4 quadrants of the nail) and fingernail matrix psoriasis (0 to 4) depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed and fingernail matrix psoriasis in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, and the sum of all the fingernails is the total NAPSI score (range, 0 to 80). LS Means in NAPSI score were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, who had fingernail involvement at baseline and had at least one post-dose measurement of NAPSI.|||Units on a Scale||Standard Error|Least Squares Mean
2653046|NCT01646177|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects."|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol, and had at least one post-dose measurement of DLQI.|||Units on a Scale||Standard Error|Least Squares Mean
2653047|NCT01646177|Secondary|Number of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]|"The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Participants indicate their overall severity of itching from Psoriasis by circling the number that best describes the worst level of itching in the past 24 hours."|Baseline, Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or did not follow the protocol, and had an Itch NRS score >=4 at baseline. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the NRI analysis.|||Participants|||Number
2653048|NCT01646177|Secondary|Number of Participants Achieving 100% (PASI 100) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 100 were defined as having an improvement of at least 100% in the PASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.|||Participants|||Number
2653049|NCT01646177|Secondary|Number of Participants Achieving ≥90% (PASI 90) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 90 were defined as having an improvement of at least 90% in the PASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.|||Participants|||Number
2653050|NCT01646177|Secondary|Number of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA)|The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0) response was defined as a post-baseline sPGA score of 0.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.|||Participants|||Number
2653051|NCT01646177|Primary|Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI)|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 was defined as having an improvement of at least 75% in the PASI scores compared to baseline.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.|||Participants|||Number
2653052|NCT01646177|Primary|Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA)|The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1.|Week 12|All randomized participants, even if the participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Participants who did not meet clinical response criteria or have missing data at Week 12 will be considered non-responders for the Non-Responder Imputation (NRI) analysis.|||Participants|||Number
2653053|NCT01646151|Primary|IOP at Week 12|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.|Week 12|All patients with data for this outcome measure|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2653054|NCT01646151|Secondary|Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops|Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No.|Week 12|All patients|||Percentage of Patients|||Number
2653055|NCT01646151|Secondary|Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment|Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No.|12 Weeks|All patients|||Percentage of Patients|||Number
2653056|NCT01646151|Secondary|Physician Assessment of Patient Compliance Compared to Previous Therapy|Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.|Week 12|All patients with data for this outcome measure|||Patients|||Number
2653057|NCT01646151|Secondary|Physician Assessment of Tolerability on a 4-Point Scale|Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|Week 12|All patients with data for this outcome measure|||Patients|||Number
2653058|NCT01646151|Secondary|Patient Assessment of Tolerability on a 4-Point Scale|Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|Week 12|All patients with data for this outcome measure|||Patients|||Number
2653059|NCT01646151|Secondary|Physician Evaluation of IOP Lowering in the Study Eye(s)|IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.|Week 12|All patients with data for this outcome measure|||Eyes|Participants||Number
2653060|NCT01646151|Primary|Intraocular Pressure (IOP) at Baseline|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.|Baseline|All patients with data for this outcome measure|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2653061|NCT01646138|Primary|Percent MMID|Percent of individuals experiencing mild to moderate influenza infection (MMID, defined as active shedding and symptoms of influenza A) in each dosing group.|67 days after influenza inoculation|Analysis of the subjects who completed the study after receiving a particular dose of Ca/04/2009/H1N1 Vero Grown Challenge Virus.|||percentage of participants|||Number
2653062|NCT01646125|Secondary|Time to Progression (TTP)|TTP will be compared between treatment arms. The TTP will be based on local investigator assessment per RECIST 1.1|baseline, until disease progression up to 24 months|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.||||||
2653063|NCT01646125|Secondary|Change in Laboratory Paramenters|Changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs), Dose interruptions, reductions and dose intensity.|baseline, until disease progression up to 24 months|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.||||||
2653064|NCT01646125|Secondary|Rate of Adverse Events (AEs)|To evaluate safety and tolerability of AUY922 compared to chemotherapy agents pemetrexed or docetaxel.|baseline, until disease progression up to 24 months|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.||||||
2653065|NCT01646125|Secondary|Duration of Response (DOR)|The DOR will be compared between treatment arms. The DOR will be based on local investigator assessment per RECIST 1.1|baseline, until disease progression up to 24 months|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.||||||
2653066|NCT01646125|Secondary|Time to Response (TRR)|TTR was to compare between treatment arms. The TTR was to be based on local investigator assessment per RECIST 1.1|baseline, until disease progression up to 24 months|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.||||||
2653067|NCT01646125|Secondary|Disease Control Rate (DCR)|Duration of DCR will be compared between treatment arms. The duration of DCR will be based on local investigator assessment per RECIST 1.1|baseline, until disease progression up to 24 months|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.||||||
2653068|NCT01646125|Secondary|Overall Survival (OS)|OS is defined as the time from the date of randomization to date of death due to any cause. If a death has not been observed by the date of analysis cutoff, then OS was to be censored at the last known date patient was alive.|from randomization until death up to death|The data monitoring committee (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.||||||
2653069|NCT01646125|Secondary|Overall Response Rate (ORR)|ORR was to be compared between treatment arms. The ORR was to be based on local investigator assessment per Response Evaluation Criteria In Solid Tumors Criteria 1.1 (RECIST 1.1). Per this criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.This outcome measure was originally planned to be analyzed up to 24 months. The DMC recommendation at the IA was to stop the study for futility. As a result, collection of all the efficacy assessments was stopped at that time.|16 months|The data monitoring committee's (DMC's) recommendation based on the Interim Analysis (IA) results was to terminate the study early due to futility; collection of efficacy data for assessment was stopped at that time.|||Participants|||Number
2653070|NCT01646125|Primary|Progression Free Survival (PFS)|Compared PFS between the treatment of AUY922 to comparators Pemetrexed or Docetaxel. Progression-free survival (PFS) based on local investigator assessment per RECIST 1.1 was the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient had not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|16 months|Efficacy analysis set (EAS) compromised of a subset of patients in the FAS who received 2 lines of prior antineoplastic therapy consisting of a platinum-based treatment & an EGFR TKI treatment. The DMC recommendation at Interim analysis was to stop the study for futility. As a result, collection of all efficacy assessments was stopped.|||Months||90% Confidence Interval|Median
2653071|NCT01646073|Secondary|Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period B]|Short Form-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Summations of item scores of the same subscale give the subscale scores, which were transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores were constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. The difference from baseline to week 12 in SF-36 PCS and MCS was calculated.|Baseline to Week 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.|||scores on a scale||Standard Deviation|Mean
2653072|NCT01646073|Secondary|Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period A]|Short Form-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS). The SF-36 consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Summations of item scores of the same subscale give the subscale scores, which were transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL. PCS and MCS scores were constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score. The difference from baseline to week 12 in SF-36 PCS and MCS was calculated.|Baseline to Week 12|ITT_A: all participants that were randomized in Week 0 (Baseline); LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.|||scores on a scale||Standard Error|Mean
2653073|NCT01646073|Secondary|"Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 [Period B]"|The DLQI measures how much a participant's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.|Week 16 and Week 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
2653074|NCT01646073|Secondary|"Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 [Period A]"|The DLQI measures how much a subject's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.|Baseline, Week 3, and Week 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
2653075|NCT01646073|Secondary|"Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 [Period B]"|The DLQI measures how much a participant's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.|Week 16 and Week 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
2653076|NCT01646073|Secondary|"Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 [Period A]"|The DLQI measures how much a subject's skin problem affected their life over the last week. The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.|Baseline, Week 3, and Week 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
2657191|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 8|Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 8||||units on a scale||Standard Deviation|Mean
2653077|NCT01646073|Secondary|"Percentage of Participants With a Physician's Global Assessment (PGA) of Clear or Minimal [Period B]"|The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'|Weeks 16, 19, and 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
2653078|NCT01646073|Secondary|"Percentage of Participants With a Physician's Global Assessment (PGA) of Clear or Minimal [Period A]"|The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'|Baseline and Weeks 3, 7, and 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
2653079|NCT01646073|Secondary|"Percentage of Participants With a Physician's Global Assessment (PGA) of Clear [Period B]"|The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'|Weeks 16, 19, and 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
2653080|NCT01646073|Secondary|"Percentage of Participants With a Physician's Global Assessment (PGA) of Clear [Period A]"|The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'|Baseline and Weeks 3, 7, and 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
2653081|NCT01646073|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B]|The percentage of participants with a greater than or equal to 50%, 90%, or 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI 50/90/100). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Weeks 16, 19, and 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
2653082|NCT01646073|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A]|The percentage of participants with a greater than or equal to 50%, 90%, or 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI 50/90/100). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Weeks 3, 7, and 12|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
2653083|NCT01646073|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period B]|PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Baseline to Week 24|ITT_B: all participants who received at least 1 dose of study drug in Period B; LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.|||percent change||Standard Deviation|Mean
2653084|NCT01646073|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period A]|Psoriasis Area and Severity Index (PASI), is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Baseline to Week 12|ITT_A: all participants that were randomized in Week 0 (Baseline); Last observation carried forward (LOCF): used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.|||Percent change||Standard Error|Mean
2653085|NCT01646073|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period B]|The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI). PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Weeks 16, 19, and 24|Intent to Treat Population B (ITT_B): all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
2653086|NCT01646073|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period A]|The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI), other than Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Weeks 3 and 7|ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
2653087|NCT01646073|Primary|Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12|The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked). The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.|Week 12|Intent to Treat Population A (ITT_A): all participants who were randomized at Week 0 (Baseline); Non-responder imputation (NRI): any participant who had a missing value at a specific visit as non-responder for that visit.|||percentage of participants|||Number
2653088|NCT01646021|Other Pre-specified|The Mean Change From Baseline in Euro QoL Five-Dimension (EQ-5D-5L) Scores for Each Post Baseline Assessment|The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, using 5 levels (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and possible total score range -0.594 to 1; higher score indicates a better health state.|Baseline, Cycle 2, 3, 4, 5, 6, 7, 8, 11, 14, 17, 20, 28, 36 and End of treatment (approximately up to 23 months)|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. The 'N' (number of participants analyzed) signifies the number of participants evaluated for this outcome measure.|||Units on scale||Standard Deviation|Mean
2653089|NCT01646021|Other Pre-specified|Days of Hospitalization and Emergency Room Visits Reported Related Medical Resource Utilization Information (MRUI)|Medical resource utilization data associated with medical encounters related to disease was reported for all participants throughout the study.|Approximately up to 28.2 months|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Days||Standard Deviation|Mean
2653090|NCT01646021|Other Pre-specified|Number of Emergency Room Visits Reported Related Medical Resource Utilization Information (MRUI)|Medical resource utilization data associated with medical encounters related to disease was reported for all participants throughout the study.|Approximately up to 28.2 months|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. The 'N' (number of participants analyzed) signifies the number of participants responded for this outcome measure.|||Emergency room visits||Standard Deviation|Mean
2653091|NCT01646021|Other Pre-specified|Number of Hospitalizations Reported Related Medical Resource Utilization Information (MRUI)|Medical resource utilization data associated with medical encounters related to disease was reported for all participants throughout the study.|Approximately up to 28.2 months|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. The 'N' (number of participants analyzed) signifies the number of participants responded for this outcome measure.|||Hospitalizations||Standard Deviation|Mean
2653092|NCT01646021|Other Pre-specified|Number of Participants With Biomarkers That Alter B-cell Receptor (BCR) Signaling or Activate Alternative Signaling Pathways and to Explore Their Association With Response or Resistance to Ibrutinib|Biomarker evaluations to identify markers altering BCR signaling or activate alternative signaling pathways and explore their association with response or resistance to ibrutinib. Next-generation sequencing at baseline identifies possible primary resistance mutations and those found only at progression are acquired mutations on therapy.|Approximately up to 28.2 months||||Participants|||Number
2653093|NCT01646021|Other Pre-specified|Area Under the Plasma Concentration of Ibrutinib During Steady State (AUC-ss)|The AUC-ss is the area under the plasma concentration time curve observed during steady state.|Cycle 1 and 2 (Day 1): Predose, 1, 2, 4 hr. postdose; Cycle 3 (day 1): Predose (Each cycle is of 21 days)|Pharmacokinetic analysis set included the participants who had received one dose of study drug had at least 1 pharmacokinetic sample obtained post-treatment.|||nanogram*hour per milliliter (ng*h/mL)||Standard Deviation|Mean
2653094|NCT01646021|Other Pre-specified|One Year Survival Rate|One -year survival rate, defined as the proportion of participants who were alive 1 year after randomization.|Month 12|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Proportion of participants||95% Confidence Interval|Number
2653095|NCT01646021|Other Pre-specified|Extent of Exposure of Time|Extent of exposure is defined as the duration of the treatment administered during the study. Duration of exposure is calculated as the number of months between the start and end of treatment.|Approximately up to 46.8 months|Safety Analyses Set (SAS) population includes all the randomized participants who received at least 1 dose of study agent (ibrutinib or temsirolimus) during the treatment phase.|||Months||Full Range|Median
2653096|NCT01646021|Other Pre-specified|Time to Response|Time to response for participants with CR/PR, defined as the interval between the date of randomization and date of initial documentation of response.|Approximately up to 2.8 years|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. The 'N' (number of participants analyzed) signifies the number of participants responded for this outcome measure.|||Months||Full Range|Median
2653097|NCT01646021|Secondary|Number of Participants Affected With Treatment-emergent Adverse Events|An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Time from first dose of study drug until the last dose date + 30 days or the start of a subsequent anti-neoplastic therapy, whichever occur earlier (Approximately up to 4 years)|Safety population included all randomized participants who received at least 1 dose of the study drug.|||Participants|||Count of Participants
2653098|NCT01646021|Secondary|Time to Worsening in the Lymphoma Sub Scale of Functional Assessment of Cancer Therapy- Lymphoma (FACT-Lym)|Time to worsening in the Lymphoma subscale of the FACT-Lym, defined as the interval from the date of randomization to the start date of worsening. Worsening was defined by a 5-point decrease from baseline. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (higher the worse). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life.|Approximately up to 48 months|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Weeks||95% Confidence Interval|Median
2653099|NCT01646021|Secondary|Progression-Free Survival 2|Progression-free survival 2 defined as the time interval between the date of randomization and date of event, defined as progressive disease as assessed by investigator that started after the next line of subsequent anti-neoplastic therapy (including cross-over to ibrutinib), death from any cause, or the start of the second subsequent anti-neoplastic therapy if no progressive disease was recorded after the first subsequent anti-neoplastic therapy.|Approximately up to 48 months|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Months||95% Confidence Interval|Median
2653100|NCT01646021|Secondary|Time-to-Next Treatment|Time to next treatment was measured from the date of randomization to the start date of any anti-neoplastic treatment subsequent to study treatment.|Approximately up to 48 months|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Months||95% Confidence Interval|Median
2653101|NCT01646021|Secondary|Duration of Response|Duration of response (CR or PR), defined as the duration in days from the date of initial response to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death. The analysis was based on the investigator assessment.|Approximately up to 48 months|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received. The 'N' (number of participants analyzed) signifies the number of participants responded for this outcome measure.|||Months||95% Confidence Interval|Median
2653102|NCT01646021|Secondary|Overall Survival (OS)|Overall survival (OS) was defined as the interval between the date of randomization and the date of death from any cause.|Approximately up to 48 months|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Months||95% Confidence Interval|Median
2653103|NCT01646021|Secondary|Overall Response Rate (ORR)|ORR is defined as the percentage of participants who achieved either CR or PR as best overall response based on the investigator assessment. CR is Disappearance of all target lesions while PR is greater than or equal to 30 % decrease in the sum of the longest diameter of target lesions and Overall Response (OR) is sum of CR and PR.|Approximately up to 48 months|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Percentage of participants|||Number
2653104|NCT01646021|Primary|Progression Free Survival (PFS)|PFS is defined as the duration in months from the date of randomization to the date of progression disease (PD) or relapse from complete response (CR) or death whichever was reported first and was assessed based on the investigator assessment. Revised Response Criteria for Malignant Lymphoma categorizes the response of the treatment of a patient's tumour to CR (the disappearance of all evidence of disease), Relapsed Disease or PD (Any new lesion or increase by greater than or equal to [>=] 50 percent [%] of previously involved sites from nadir).|Time from the date of randomization until the date of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death, whichever occurred first (approximately 48 months)|The Intent-to-Treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Months||95% Confidence Interval|Median
2653105|NCT01645930|Secondary|Duration of Response (DOR)|DOR was defined as the length of time between the date of first documented response (PR, VGPR, or CR) and the date of first documented progressive disease (PD). According to IMWG criteria: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour.|From date of documentation of a confirmed response to date of progressive disease, (approximately 20 months)|Safety population was defined as all participants who received at least 1 dose of study drug.|||months||Full Range|Median
2653106|NCT01645930|Secondary|Percentage of Participants With Confirmed Best Response Category|Percentage of participants who achieve or maintain any best response category during the treatment period were reported. Best response includes complete response (CR), very good partial response (VGPR), and partial response (PR). Response was assessed according to IMWG criteria. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour.|From Cycle 1, Day 1 to Cycle 3, Day 1 until disease progression (approximately 20 months)|Safety population was defined as all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2653490|NCT01643525|Primary|Sensitivity, Specificity and Predictive Values of the Jan Medical DC1 System in Detecting Ischemia Within 12 Hours of Known Stroke Onset in Comparison to Follow up CT and MRI.||At study completion- approximately 8 months|Terminated study, data incomplete. Data not analyzed.||||||
2653107|NCT01645930|Primary|Number of Participants With Clinically Significant Vital Signs Reported as Adverse Events|The number of participants who meet markedly abnormal criteria for vital signs, included diastolic and systolic blood pressure, heart rate, oral temperature, respiratory rate, and body weight.|From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days)|Safety population was defined as all participants who received at least 1 dose of study drug.|||participants|||Number
2653108|NCT01645930|Primary|Number of Participants With Clinically Significant Laboratory Abnormalities Reported as Adverse Events of ≥Grade 3 Intensity|Clinically significant laboratory abnormalities were defined as any test results which were observed beyond the clinically acceptable limits as per the discretion of investigator. Clinical laboratory tests included chemistry, hematology and urinalysis tests.|From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days)|Safety population was defined as all participants who received at least 1 dose of study drug.|||participants|||Number
2653109|NCT01645930|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or was a medically important event.|From the first dose of study drug through 30 days after the last dose of study drug (up to 577 days)|Safety population was defined as all participants who received at least 1 dose of study drug.|||participants|||Number
2653110|NCT01645930|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was defined as any of the following AEs that were considered by investigator to be possibly related to therapy: 1. Grade 4 neutropenia lasting at least 7 consecutive days; 2. Grade 3 neutropenia with fever and/or infection; 3. Grade 4 thrombocytopenia at least 7 consecutive days; 4. Grade 3 thrombocytopenia with clinically significant bleeding; 5. Platelet count <10,000/mm^3; 6. Grade 2 peripheral neuropathy with pain or ≥Grade 3 peripheral neuropathy; 7. Grade 3 or greater nausea and / or emesis despite the use of optimal anti-emetic prophylaxis; 8. Grade 3 or greater diarrhea that occurred despite maximal supportive therapy; 9. Any other Grade 3 or greater nonhematologic toxicity with the following exceptions: Grade 3 arthralgia/myalgia, <1 week Grade 3 fatigue; 10. A delay of >2 weeks in the subsequent cycle of treatment; 11. Other combination study drug-related nonhematologic toxicities ≥Grade 2 that, in the opinion of the investigator, required discontinuation of study drug.|Cycle 1 (up to Day 28)|DLT-evaluable population consisted of participants who either had a DLT during Cycle 1 or received all scheduled doses and completed all study procedures in Cycle 1 without having a DLT.|||participants|||Number
2653111|NCT01645930|Primary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Ixazomib||Cycle 1, Day 15 pre-dose and multiple time-points (up to 336 hours) post-dose|PK-evaluable population included all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters.|||hr*ng/mL||Standard Deviation|Mean
2653112|NCT01645930|Primary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for Ixazomib||Cycle 1, Day 1 pre-dose and multiple time-points (up to 168 hours) post-dose|Participants from the PK-evaluable population, all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters, with data available for analysis.|||hr*ng/mL||Standard Deviation|Mean
2653113|NCT01645930|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib||Cycle 1, Day 15 pre-dose and multiple time-points (up to 336 hours) post-dose|PK-evaluable population included all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters.|||hours||Full Range|Median
2653114|NCT01645930|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib||Cycle 1, Day 1 pre-dose and multiple time-points (up to 168 hours) post-dose|Participants from the PK-evaluable population, all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters, with data available for analysis.|||hours||Full Range|Median
2653115|NCT01645930|Primary|Cmax: Maximum Observed Plasma Concentration for Ixazomib||Cycle 1, Day 15 pre-dose and multiple time-points (up to 336 hours) post-dose|PK-evaluable population included all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters.|||ng/mL||Standard Deviation|Mean
2653116|NCT01645930|Primary|Cmax: Maximum Observed Plasma Concentration for Ixazomib||Cycle 1, Day 1 pre-dose and multiple time-points (up to 168 hours) post-dose|Participants from the Pharmacokinetic (PK)-evaluable population, all participants who received protocol-specified dosing during Cycle 1, did not receive any excluded concomitant medications and had sufficient concentration-time data to permit reliable estimation of PK parameters, with data available for analysis.|||ng/mL||Standard Deviation|Mean
2653117|NCT01645735|Other Pre-specified|Safety Evaluation|Adverse events (AEs), serious adverse events (SAEs), deaths, discontinuation due to AEs|Baseline (Day 0) to Day 49|Safety Population: all randomized subjects who received any amount of IV study drug|||participants|||Number
2653118|NCT01645735|Other Pre-specified|Microbiological Outcomes by Baseline Pathogen at TOC in the Microbiological Modified Intent-to-Treat (mMITT) Population|An overall microbiological outcome was derived based on the subject's baseline pathogen. As no follow-up specimens were collected at the TOC visit for any subjects, all microbiological outcomes were derived based strictly on clinical outcomes, as either presumed eradication (ie, source specimen was not available to culture and the subject was assessed as clinical cure) , presumed persistence (ie, source specimen was not available to culture and the subject was assessed as a clinical failure), or indeterminate (ie, source specimen was not available to culture and the subject's clinical response was assessed as indeterminate).|Test of Cure, an average of 3 weeks|mMITT Population: a subset of the MITT Population, including subjects for whom at least 1 typical bacterial pathogen has been identified from an adequate microbiological specimen at baseline|||participants|||Number
2653119|NCT01645735|Primary|Clinical Outcome at Test of Cure (TOC) in the MITT Population|"An assessment of clinical outcome was made by the Investigator at TOC. The clinical outcome categories were:~Cure: Resolution of all acute signs and symptoms of CABP or improvement to such an extent that no further antimicrobial therapy was required~Failure: Subjects who meet either of the following criteria:~Incomplete resolution or worsening of CABP signs and symptoms or development of new CABP signs or symptoms requiring alternative nonstudy antimicrobial therapy~Death in which CABP is contributory~Indeterminate: Study data are not available for evaluation of efficacy for any reason, including:~Death in which CABP is clearly noncontributory~Lost to follow-up~Extenuating circumstances precluding classification as a cure or failure~A favorable clinical outcome at Test-of Cure (TOC) was clinical cure."|Test of Cure, an average of 3 weeks|MITT Population: all randomized subjects who receive any amount of IV study drug and who have a confirmed diagnosis of CABP with risk factors for MRSA (excluding those that have a sole atypical pathogen)|||participants|||Number
2653120|NCT01645735|Primary|Clinical Response at Study Day 4 in the Modified Intent-to-Treat (MITT) Population|"Clinical response was defined as meeting all of the following criteria:~Symptom Improvement - Improvement in at least 2 and no worsening of any of the following symptoms compared to baseline:~Cough~Dyspnea~Sputum production~Chest pain~Clinical Stability (per Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) guidelines; Mandell et al, 2007):~Temperature ≤ 37.8°C~Heart rate ≤ 100 beats/min~Respiratory rate ≤ 24 breaths/min~Systolic blood pressure ≥ 90 mmHg~Oxygen saturation ≥ 90%~Confusion/disorientation absent"|Study Day 4|MITT Population: all randomized subjects who receive any amount of IV study drug and who have a confirmed diagnosis of Community-Acquired Bacterial Pneumonia (CABP) with risk factors for Methicillin-Resistant Staphylococcus aureus (MRSA) (excluding those that have a sole atypical pathogen)|||participants|||Number
2653121|NCT01645709|Secondary|Number of Subjects With Adverse Events|Compare the safety of IA verapamil versus IA placebo using adverse events (AEs) as a comparator|13 weeks|||||||
2653122|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• Rescue medication use"|13 weeks|||||||
2653123|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• Patient Global Impression of Change (PGIC)"|13 weeks|||||||
2653124|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• Response rate"|13 weeks|||||||
2653125|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• Difference in the current in-clinic pain intensity using the 0-10 NRS before and after exercise at each visit"|13 weeks|||||||
2653126|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• In-clinic 24-hour recall pain intensity using the 0-10 numerical rating scale (NRS) at each visit"|13 weeks|||||||
2653127|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• WOMAC pain subscale as measured from 2 to 12 weeks post-treatment using an AUC approach"|13 weeks|||||||
2653128|NCT01645709|Secondary|Compare Efficacy of Verapamil to Placebo Compared to Baseline|"To compare the efficacy of IA verapamil and IA placebo using change from baseline in the following:~• WOMAC total and subscale scores for pain, function, and stiffness at each visit"|13 weeks|||||||
2653129|NCT01645709|Primary|Compare Efficacy of Verapmil vs Placebo at Week 4|To compare the efficacy of IA verapamil versus IA placebo for pain relief using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at week 4.|4 weeks|||||||
2653130|NCT01645280|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 28|The Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Week 28|The m-ITT included participants who received at least 1 (partial or complete) dose of study agent. For early escape, data at or prior to Week 16 were carried forward through Week 28.|||units on scale||Standard Error|Least Squares Mean
2653131|NCT01645280|Secondary|Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 12|The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 2) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 3) Physician's Global Assessment of Disease Activity-Visual Analog Scale, 4) Patient's Assessment of Physical Function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI), 5) C-reactive Protein (CRP).|Week 12|The m-ITT population included participants who received at least 1 (partial or complete) dose of study agent.|||percentage of participants|||Number
2653132|NCT01645280|Secondary|Change From Baseline in Disease Activity Index Score 28 (DAS28; Using C-reactive Protein [CRP]) Score at Week 28|The DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, CRP (mG/L) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|From Baseline to Week 28|The modified-ITT population included participants who received at least 1 (partial or complete) dose of study agent. For early escape, data at or prior to Week 16 were carried forward through Week 28.|||units on scale||Standard Error|Least Squares Mean
2653242|NCT01644474|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|Up to Week 24|ITT population.|||percentage of participants|||Number
2653133|NCT01645280|Primary|Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 28|The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) patient's assessment of arthritis pain-visual analog scale, 2) patient's global assessment of disease activity-visual analog scale, 3) physician's global assessment of disease activity-visual analog scale, 4) patient's assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-Di), 5) C-reactive protein (CRP).|Week 28|The intent-to-treat (ITT) population included all randomized participants. For early escape, data at or prior to Week 16 were carried forward through Week 28.|||percentage of participants|||Number
2653134|NCT01645176|Primary|Change in Synovitis|"MRI readings performed independently by two musculoskeletal radiologists, using a semi-quantitative scoring system based on MRI assessment of knee OASynovitis scored using axial & sagittal CE-MRI sequence, while effusion & bone marrow lesions were scored using non-CE-MRI sequences of parent study.~Synovitis defined as enhancing thickened synovium (>2 mm) & was evaluated at nine sites of joint-medial & lateral parapatellar recess, suprapateller, infrapatellar, intercondylar, medial & lateral perimeniscal, & adjacent to anterior & posterior cruciate ligaments (ACL/PCL) in all subjects. Synovial thickness was scored semi-quantitatively based on maximal thickness in any slice at each site as follows: grade 0 if <2mm, grade 1 if 2-4 mm & grade 2 if >4mm. For assessment of whole knee synovitis scores of all sites were summed and categorized: 0-4 normal or equivocal synovitis; 5-8 mild synovitis; 9-12 moderate synovitis & >/= 13 severe synovitis."|baseline and 16 weeks|Participants with osteoarthritis of knee|||units on a scale||Standard Deviation|Mean
2653135|NCT01645111|Primary|Time to Achieve Target MAP|The time between start of clevidipine infusion and patient reaching target mean arterial pressure (MAP) at 55-65 mmHg|First 30 minutes of infusion||||minutes||Standard Deviation|Mean
2653136|NCT01645098|Secondary|EtCO2 Change After Dexmedetomidine Loading Dose|Change in end-tidal carbon dioxide from baseline measurement to immediately post dexmedetomidine infusion.|Baseline to immediately post dexmedetomidine infusion.||||mmHg||Standard Deviation|Mean
2653137|NCT01645098|Secondary|Oxygen Saturation Change After Dexmedetomidine Loading Dose|Change in oxygen saturation from baseline measurement to immediately post dexmedetomidine infusion.|Baseline to immediately post dexmedetomidine infusion.||||percentage of oxygen||Standard Deviation|Mean
2653138|NCT01645098|Secondary|Mean Arterial Pressure (MAP) Change After Dexmedetomidine Loading Dose|Change in MAP from baseline measurement to immediately post dexmedetomidine infusion measured via blood pressure cuff.|Baseline to immediately post dexmedetomidine infusion.||||mmHg||Standard Deviation|Mean
2653139|NCT01645098|Secondary|Heart Rate Change After Dexmedetomidine Loading Dose|Difference in heart rate from baseline to immediately following infusion of dexmedetomidine loading dose.|Baseline to immediately post dexmedetomidine infusion.||||BPM||Standard Deviation|Mean
2653140|NCT01645098|Primary|Time to Sedation Score of 3-4|The depth of sedation was judged using the University of Michigan Sedation Scale (UMSS). The score ranges from zero, awake and alert, to four, unarousable. A score of three, deeply sedated, or more was considered to be an appropriate level of sedation for the procedure.|Immediately prior to incision||||minutes||Standard Deviation|Mean
2653141|NCT01645059|Secondary|Disseminated Breast Cancer Treatment-Smoking|Analyse disseminated Breast Cancer treatment and clinical profile (Smoking)|one day (there is no follow-up, it is a cross-sectional study)||||percentage of smoking participants|||Number
2653142|NCT01645059|Secondary|Disseminated Breast Cancer Treatment-physical Activity|Analyse disseminated Breast Cancer treatment and clinical profile (physical activity)|one day (there is no follow-up, it is a cross-sectional study)||||percentage of patients physical activity|||Number
2653143|NCT01645059|Secondary|Disseminated Breast Cancer Treatment-Age|Analyse disseminated Breast Cancer treatment and clinical profile (age)|one day (there is no follow-up, it is a cross-sectional study)||||years||Standard Deviation|Mean
2653144|NCT01645059|Secondary|Adjuvant Treatment-Node Affectation|"Adjuvant treatment and clinical profile (Node affectation)~The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)"|one day (there is no follow-up, it is a cross-sectional study)||||percentage of patients node affectation|||Number
2653145|NCT01645059|Secondary|Adjuvant Treatment-Physical Activity|"Adjuvant treatment and clinical profile (Physical activity)~The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)"|one day (there is no follow-up, it is a cross-sectional study)||||percentage of patients physical activity|||Number
2653146|NCT01645059|Secondary|Adjuvant Treatment and Age|"Adjuvant treatment and clinical profile (age)~The patients analysed in this outcome are patients initially diagnosed with localized breast cáncer (N=66)"|one day (there is no follow-up, it is a cross-sectional study)||||years||Standard Deviation|Mean
2653147|NCT01645059|Secondary|The Pattern of Treatment in Metastatic Breast Cancer: Chemotherapy, Hormonal Therapy Anti-HER Biological Therapy||one day (there is no follow-up, it si a cross-sectional study)||||percentage of participants|||Number
2653148|NCT01645059|Secondary|Adjuvant Treatment in Primary Breast Cancer: Chemotherapy (Treatment With TAC-Docetaxel, Adriamicine and Cyclophosphamide), Hormonal Therapy Anti-HER Biological Therapy||one day (there is no follow-up, it is a cross-sectional study)||||percentage of participants||95% Confidence Interval|Number
2653149|NCT01645059|Primary|The Patient Clinical Profile (General Clinical Data and Breast Cancer Characteristics)|General clinical data: age, weigh, height, Perfomance Status (ECOG Eastern Cooperative Oncology Group, runs from 0 to 5, with 0 denoting perfect health and 5 death), Breast cancer characteristics: familiar history of breast cancer, initial diagnostic (localized or disseminated), age at diagnostic, TNM (tumor node metástasis), tumor size, node involvement, primary tumor surgery, HER2 overexpression, histological Classification (grades I, II and III,determines the urgency and aggressiveness of treatment, as the higher grades do tend to correspond to poorer survival rates and prognosis), time from the primary breast cancer to distant relapse, description and localization of metastasis|1 day (there is no follow-up, it is a cross-sectional study)||||percentage of participants||95% Confidence Interval|Number
2653276|NCT01644396|Other Pre-specified|Change From Baseline in Blood Cell Counts|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||× 10^9 cells/L||Standard Deviation|Mean
2653150|NCT01644890|Secondary|Overall Response Rate|"ORR is the proportion of patients who are assessed as complete response or partial response as the best overall response among evaluable patients, according to RECIST Ver.1.1.~Assessment period was from the day of randomisation until the first observation of lesion progression or death"|Baseline, every 6 weeks of study treatment period, and end of study.|All randomized patients who received study drug at least once and who had no major violations of the eligiblity criteria|||percentage of participants||95% Confidence Interval|Median
2653151|NCT01644890|Secondary|Overall Survival|"OS is defined as the period from the day of randomization until the day of death from any cause.~Assessment period was from the day of randomisation until the first observation of lesion progression or death"|Baseline, every 6 weeks of study treatment period, and end of study.|History of chemotherapy for metastatic or recurrent breast cancer (yes/no), History of treatment using a taxane anticancer drug (yes/no), ER status [ER (+) or ER (-)], and Disease free interval (<12 months or ≥12 months) were covariates for adjustment.|||months||95% Confidence Interval|Median
2653152|NCT01644890|Primary|Progression Free Survival|"PFS is defined as the period from the day of randomization until the first observation of lesion progression or death from any cause. Disease progression is defined as PD according to RECIST Ver. 1.1.~Assessment period was from the day of randomisation until the first observation of lesion progression or death"|Baseline, every 6 weeks of study treatment period, and end of study,|All randomized patients who received study drug at least once and who had no major violations of the eligiblity criteria|||months||95% Confidence Interval|Median
2653153|NCT01644734|Secondary|Change in the Total CAT Score (Value Baseline Minus 3 Months)|The change represents the value at baseline minus the value after 3 months. The total CAT score ranges from 0 to 40 where 0 represents no symptoms and 40 very bad symptoms. Therefore, a positive value for the change in the total CAT score means an improvement.|Baseline, 3 months|Patients from FAS|||units on a scale||Standard Deviation|Mean
2653154|NCT01644734|Primary|Number of Patients Maintaining or Improving Their Health Status|The health status was measured by the total COPD Assessment Test (CAT) score at baseline and at the end of the observation period after app. 3 months (visit 3). Therefore, the total CAT score at baseline and at Visit 3 was calculated by adding up the scores of the single questions of the CAT questionnaire. In the case of one or more missing items the total score was not determined for the specific visit. The health status is considered to be maintained or improved if the change in the total CAT score from baseline at Visit 3 is ≥0.|Baseline, 3 months|Patients from the Full Analysis Set (FAS) which includes all patients in the treated set and who have valid CAT questionnaire results both at baseline and at visit 3.|||participants|||Number
2653155|NCT01644695|Secondary|Intra and Post-Operative Complications|Record of intra and post operative complications resulting from BARS(bony anchoring reinforcement system) procedure including but not limited to scarring, pain, numbness, intra-abdominal injury, bleeding, death, infection, anesthesia complications, and need for further surgery.|ongoing, average 2.4 years|There were 6 instances of wound dehiscence. There were 2 instances each of infection, necrosis, DVT,hematoma, and neuroma. There was 1 instance each of cellulitis, bowel obstruction, entrapped nerve, and temporary numbness. Further surgery was required 7 times, of which 3 included partial removal of the mesh. 27 complications in total.|||participants|||Number
2653156|NCT01644695|Primary|Recurrence Rate|Evidence of complex incisional hernia recurrence after treatment with BARS procedure.|ongoing, average 2.4 years|Subjects were chosen per protocol according to their candidacy for the BARS procedure. All patients were monitored closely following the operation.|||participants|||Number
2653157|NCT01644643|Secondary|Plasma Concentrations for Ceftazidime and Avibactam — cUTI in PK Analysis Set|Blood samples were taken on Day 3 for ceftazidime and avibactam plasma concentration.|Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug|PK Analysis set|||NG/ML||Full Range|Geometric Mean
2653158|NCT01644643|Secondary|Plasma Concentrations for Ceftazidime and Avibactam — cIAI in PK Analysis Set|Blood samples were taken on Day 3 for ceftazidime and avibactam plasma concentration.|Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 to 90 minutes after stopping study drug, anytime between 300 to 360 minutes after stopping study drug|PK Analysis set|||NG/ML||Full Range|Geometric Mean
2653159|NCT01644643|Secondary|The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set|Proportion of patients with Day 28 all-cause mortality in EME at TOC analysis set. The death in the cIAI patient were reviewed independently by the SRP Chair.|From first infusion to Day 28|Extended microbiologically evaluable at TOC|||Participant|||Number
2653160|NCT01644643|Secondary|The 28 Days All Cause Mortality Rate in mMITT Analysis Set|Proportion of patients with Day 28 all-cause mortality in mMITT analysis set. The death in the cIAI patient were reviewed independently by the SRP Chair.|From first infusion to Day 28|Microbiological modified intent to treat|||Participant|||Number
2653161|NCT01644643|Secondary|The Reason for Treatment Change/Discontinuation in mMITT Analysis Set|Proportion of patients in the mMITT analysis set for whom the assigned study treatment was changed, discontinued, or interrupted. Creatinine clearance (CrCl)|From first infusion to last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
2653162|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). For E.coli, MIC available values are: <=0.008, 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 8. For K. pneumoniae, MIC available values are: 0.06, 0.12, 0.25, 0.5, 1, 2, 4, >32. For P. aeruginosa, MIC available values are: 2, 4, 8, 16, 32, >32.|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC|||Participant|||Number
2653298|NCT01644331|Secondary|Worsening or Persistent Heart Failure or Death|Number of patients with worsening heart failure or death|72 hrs|baseline population|||Participants|||Count of Participants
2653163|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population). For E.coli, MIC available values are: <=0.008, 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 8. For K. pneumoniae, MIC available values are: 0.06, 0.12, 0.25, 0.5, 1, 2, 4, 32, >32. For P. aeruginosa, MIC available values are: 2, 4, 8, 16, 32, >32.|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
2653164|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Extended microbiologically evaluable at FU2|||Participant|||Number
2653165|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Extended microbiologically evaluable at FU1|||Participant|||Number
2653166|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC|||Participant|||Number
2653167|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at EOT|||Participant|||Number
2653168|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequncy in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Microbiological modified intent to treat|||Participant|||Number
2653169|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Microbiological modified intent to treat|||Participant|||Number
2653170|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
2653299|NCT01644331|Secondary|Hospital Stay|Total days spent in hospital from baseline until discharge or death|7 days|baseline population|||days||Standard Deviation|Mean
2653171|NCT01644643|Secondary|Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set|Proportion of patients with a favorable per-pathogen microbiological response for pathogens (>=10% of frequency in the combined cIAI and cUTI patients): favourable microbiological response includes: Eradication Absence (or urine quantification less than 10^4 CFU/ml for cUTI patients) of causative pathogen from an appropriately obtained specimen at the site of infection. If the patient was bacteremic at Screening, the bacteremia has also resolved. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure (specific to cIAI population).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
2653172|NCT01644643|Secondary|Per-patient Microbiological Response at FU2 in EME at FU2 Analysis Set|"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)."|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Extended microbiologically evaluable at FU2|||Participant|||Number
2653173|NCT01644643|Secondary|Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set|"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)."|cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization|Extended microbiologically evaluable at FU1|||Participant|||Number
2653174|NCT01644643|Secondary|Per-patient Microbiological Response at TOC in EME at TOC Analysis Set|"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)."|6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC|||Participant|||Number
2653175|NCT01644643|Secondary|Per-patient Microbiological Response at EOT in EME at EOT Analysis Set|"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)."|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at EOT|||Participant|||Number
2653176|NCT01644643|Secondary|Per-patient Microbiological Response at FU2 in mMITT Analysis Set|"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)."|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Microbiological modified intent to treat|||Participant|||Number
2653177|NCT01644643|Secondary|Per-patient Microbiological Response at FU1 in mMITT Analysis Set|"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)."|cUTI: 20-27 calendar days from randomization/cIAI: 27-37 calendar days from randomization|Microbiological modified intent to treat|||Participant|||Number
2653187|NCT01644643|Secondary|Clinical Response at FU2 in EME at FU2 Analysis Set|Proportion of patients with clinical cure at the FU2 visit in EME at FU2 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary.|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Extended Microbiological Evaluable at FU2 analysis set.|||Participant|||Number
2653178|NCT01644643|Secondary|Per-patient Microbiological Response at TOC in mMITT Analysis Set|"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)."|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
2653179|NCT01644643|Secondary|Per-patient Microbiological Response at EOT in mMITT Analysis Set|"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cIAI patients where the clinical response was changed to indeterminate due to a Surgical Review Panel assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)."|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
2653180|NCT01644643|Secondary|Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set|Proportion of patients with clinical cure at FU2 visit by previously failed treatment class in EME at FU2 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary.|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Extended microbiologically evaluable at FU2|||Participant|||Number
2653181|NCT01644643|Secondary|Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set|Proportion of patients with clinical cure at FU1 visit by previously failed treatment class in EME at FU1 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Extended microbiologically evaluable at FU1|||Participant|||Number
2653182|NCT01644643|Secondary|Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set|Proportion of patients with clinical cure at TOC visit by previously failed treatment class in EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC|||Participant|||Number
2653183|NCT01644643|Secondary|Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set|Proportion of patients with clinical cure at EOT visit by previously failed treatment class in EME at EOT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|28 hours after completion of last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at EOT|||Participant|||Number
2653184|NCT01644643|Secondary|Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set|Proportion of patients with clinical cure at TOC visit by previously failed treatment class in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
2653185|NCT01644643|Secondary|Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set|Proportion of patients with clinical cure at TOC visit by baseline Gram-negative pathogen (>=10% of frequency in the combined cIAI and cUTI patients) in EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Extended microbiologically evaluable at TOC|||Participant|||Number
2653186|NCT01644643|Secondary|Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set|Proportion of patients with clinical cure at TOC visit by baseline pathogen (>=10% of frequency in the combined cIAI and cUTI patients) in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
2653300|NCT01644331|Secondary|Dyspnea Likert|Number of patients that experience moderate or greater improvement (patient reported) in dyspnea by 7 point Likert scale at 48 and 72 hours|48 and 72 hours|baseline population|||Participants|||Count of Participants
2653188|NCT01644643|Secondary|Clinical Response at FU1 in EME at FU1 Analysis Set.|Proportion of patients with clinical cure at the FU1 visit in EME at FU1 analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Extended Microbiological Evaluable at FU1 analysis set.|||Participant|||Number
2653189|NCT01644643|Secondary|Clinical Response at TOC in EME at TOC Analysis Set.|Proportion of patients with clinical cure at the TOC visit in the EME at TOC analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy.Duration of study therapy was 5 to 21 days.|Extended Microbiological Evaluable at TOC analysis set.|||Participant|||Number
2653190|NCT01644643|Secondary|Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set.|Proportion of patients with clinical cure at the EOT visit in the EME at EOT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Extended Microbiological Evaluable at EOT analysis set.|||Participant|||Number
2653191|NCT01644643|Secondary|Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set|Proportion of patients with clinical cure at the FU2 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|At FU2, data was only collected for the cUTI Arms: 28-34 calendar days from randomization|Microbiological modified intent to treat|||Participant|||Number
2653192|NCT01644643|Secondary|Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set|Proportion of patients with clinical cure at the FU1 visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|cIAI: 27-37 calendar days from randomization/cUTI: 20-27 calendar days from randomization|Microbiological modified intent to treat|||Participant|||Number
2653193|NCT01644643|Secondary|Clinical Response at End of Treatment (EOT) in mMITT Analysis Set.|Proportion of patients with clinical cure at the EOT visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|28 hours after completion of last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
2653194|NCT01644643|Primary|Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set|Proportion of patients with clinical cure at the TOC visit in the mMITT analysis set. Clinical cure: Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy (other than those allowed per protocol) is necessary; for cIAI patients no drainage or surgical intervention after 96 hours from randomization is necessary (ie. drainage or surgical intervention up to 96 hours from randomization is permissible).|6-12 days after last infusion of study therapy. Duration of study therapy was 5 to 21 days.|Microbiological modified intent to treat|||Participant|||Number
2653195|NCT01644617|Secondary|Percentage of Participants Who Discontinued Study Drug Due to an AE|The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.|From first dose to last dose of treatment (Up to 24 weeks)|All Participants as Treated including all randomized participants who received at least one dose of study treatment|||Percentage of Participants|||Number
2653196|NCT01644617|Secondary|Percentage of Participants Who Experienced At Least One Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.|From first dose to last dose of treatment plus 2 weeks of follow-up (Up to 26 weeks)|All Participants as Treated including all randomized participants who received at least one dose of study treatment|||Percentage of participants|||Number
2653197|NCT01644617|Secondary|Change From Baseline in HDM-specific IgG4 Levels at Week 8|D. pteronyssinus and D. farinae serum IgG4 levels were measured using the Immunocap® assay at baseline and Week 8. IgG4 levels were expressed in Log 10 scale mg/L. Mean Week 8 IgG4 levels were compared to the mean IgG4 levels at baseline. Analysis was based on the ANOVA model with treatment as the fixed effect and reported as a least squares mean with 95% confidence interval.|Time Frame: Baseline and Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Log 10 mg/L||95% Confidence Interval|Least Squares Mean
2653198|NCT01644617|Secondary|Change From Baseline in HDM-specific IgE Levels at Week 8|D. pteronyssinus and D. farinae serum IgE levels were measured using the Immunocap® assay at baseline and Week 8. IgE levels were expressed in Log 10 scale kU/L. Mean Week 8 IgE levels were compared to the mean IgE levels at baseline. Analysis was based on the ANOVA model with treatment as the fixed effect and reported as a least squares mean with 95% confidence interval.|Baseline and Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Log 10 kU/L||95% Confidence Interval|Least Squares Mean
2653199|NCT01644617|Secondary|HDM-specific Immunoglobulin G4 (IgG4) Levels at Week 8|D. pteronyssinus and D. farinae serum IgG4 levels were measured using the Immunocap® assay at Week 8. IgG4 levels were expressed in Log 10 scale milligrams/Liter (mg/L). Analysis was based on the ANOVA model with treatment as the fixed effect and reported as mean IgG4 with a standard deviation.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Log 10 mg/L||Standard Deviation|Mean
2653200|NCT01644617|Secondary|HDM-specific Immunoglobulin E (IgE) Levels at Week 8|Dermatophagoides pteronyssinus (D. pteronyssinus) and Dermatophagoides farinae (D. farinae) serum IgE levels were measured using the Immunocap® assay at Week 8. IgE levels were expressed in Log 10 scale kilo units/Liter (kU/L). Analysis was based on the analysis of variance parametric (ANOVA) model with treatment as the fixed effect and reported as mean IgE with a standard deviation.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Log 10 kU/L||Standard Deviation|Mean
2653201|NCT01644617|Secondary|Average TOSS During EEC Challenge Session at Week 8|The average total TOSS included the evaluation of 2 ocular symptoms: gritty/feeling/red/itchy eyes and watery eyes. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 8. TOSS was the total of scores for the 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TOSS ranged from 0 to 6 points. The Week 8 TOSS was analyzed using the ANCOVA model with treatment and baseline TOSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TOSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2653202|NCT01644617|Secondary|Average TOSS During EEC Challenge Session at Week 16|The average total TOSS included the evaluation of 2 ocular symptoms: gritty/feeling/red/itchy eyes and watery eyes. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 16. TOSS was the total of scores for the 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TOSS ranged from 0 to 6 points. The Week 16 TOSS was analyzed using the ANCOVA model with treatment and baseline TOSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TOSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 16|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2653203|NCT01644617|Secondary|Average Total Ocular Symptom Score (TOSS) During EEC Challenge Session at Week 24|The average total TOSS included the evaluation of 2 ocular symptoms: gritty/feeling/red/itchy eyes and watery eyes. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TOSS was the total of scores for the 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TOSS ranged from 0 to 6 points. The Week 24 TOSS was analyzed using the ANCOVA model with treatment and baseline TOSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TOSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 24|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2653204|NCT01644617|Secondary|Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 8|The average total TSS included the evaluation of the 4 nasal symptoms of the TNSS (itchy nose, blocked nose, runny nose, and sneezing) plus the 2 ocular symptoms of the TOSS (gritty/feeling/red/itchy eyes and watery eyes). The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 8. TSS was the total of scores for the 4 nasal symptoms and 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TSS ranged from 0 to 18 points. The Week 8 TSS was analyzed using the ANCOVA model with treatment and baseline TSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2653205|NCT01644617|Secondary|Average TSS (TNSS + TOSS) During EEC Challenge Session at Week 16|The average total TSS included the evaluation of the 4 nasal symptoms of the TNSS (itchy nose, blocked nose, runny nose, and sneezing) plus the 2 ocular symptoms of the TOSS (gritty/feeling/red/itchy eyes and watery eyes). The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 16. TSS was the total of scores for the 4 nasal symptoms and 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TSS ranged from 0 to 18 points. The Week 16 TSS was analyzed using the ANCOVA model with treatment and baseline TSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 16|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2653206|NCT01644617|Secondary|Average Total Symptom Score (TSS [TNSS + TOSS]) During EEC Challenge Session at Week 24|The average total TSS included the evaluation of the 4 nasal symptoms of the TNSS (itchy nose, blocked nose, runny nose, and sneezing) plus the 2 ocular symptoms of the TOSS (gritty/feeling/red/itchy eyes and watery eyes). The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TSS was the total of scores for the 4 nasal symptoms and 2 ocular symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TSS ranged from 0 to 18 points. The Week 24 TSS was analyzed using the ANCOVA model with treatment and baseline TSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 24|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2653207|NCT01644617|Secondary|Average TNSS During EEC Challenge Session at Week 8|The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 8. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The Week 8 TNSS was analyzed using the ANCOVA model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 8|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2653208|NCT01644617|Secondary|Average TNSS During EEC Challenge Session at Week 16|The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 16. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The Week 16 TNSS was analyzed using the ANCOVA model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 16|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2653209|NCT01644617|Primary|Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24|The average total TNSS included the evaluation of 4 nasal symptoms: itchy nose, blocked nose, runny nose, and sneezing. The endpoint was based on participant diary entries over the last 4 hours of the EEC challenge session at Week 24. TNSS was the total of scores for the 4 nasal symptoms, each scored on a 4-point rating scale (0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms). The total TNSS ranged from 0 to 12 points. The 24-week TNSS was analyzed using the analysis of covariance (ANCOVA) model with treatment and baseline TNSS as covariates and expressed as a least squares mean with 95% confidence interval. A decrease in TNSS for participants receiving either dose of MK-8237 compared to placebo indicated an improvement in symptoms.|Week 24|Full Analysis Set including all randomized participants who received at least one dose of study treatment and had at least one post-randomization measurement for the analysis endpoint|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2653210|NCT01644565|Secondary|Antigen-Specific IgA Geometric Mean Titers|Antigen-Specific IgA Geometric Mean Titers as defined by Fecal IgA. Final Clinical Study Report (FCSR) highlighted titer numbers only; no numbers for measure of dispersion/precision were given; no explanation as to why standard deviation information is not present in the FCSR.|Day 0, 21,42, 56, 70|Only subjects receiving at least 2 vaccine doses were included in this assessment. Final Clinical Study Report (FCSR) highlighted titer numbers only; no numbers for measure of dispersion/precision were given; no explanation on not presenting standard deviation information is present in the FCSR.|||Geometric Mean Titers||Standard Deviation|Geometric Mean
2653211|NCT01644565|Secondary|Number of Participants With Immune Responses to Vaccine Antigens|Number of participants with immune responses to vaccine antigens from baseline. Peripheral blood mononuclear cells (PBMCs) were collected to determine IgA antibody secreting cells (ASC) responses to dscCfaE and LTB. For each antigen, pre-and post-dosing samples were tested for total and vaccine-specific numbers of IgA-ASCs using the ELISPOT assay. A positive IgA-ASC response was defined as a > 2-fold increase over the baseline value of the ASC per 10^6 PBMC, when the number of ASC was >0.5 per 10^6 in the baseline sample. When the number of baseline ASCs was less than 0.5 per 10 PBMC, a subject was considered a responder if the post-vaccination value was greater than 1.0 per 10^6 PBMC.|baseline and post dose|A total of 55 subjects across cohorts received the minimum required 2 doses of investigation product(s) and were evaluable for the immunology analysis per protocol.|||Participants|||Count of Participants
2653212|NCT01644565|Primary|Safety - Occurrence of Adverse Events|Occurrence of related and unrelated to vaccine AE's|1 year||||Number of Adverse Events|||Number
2653213|NCT01644500|Secondary|Visual Analog Scale (VAS) Score at 26 Weeks|The EQ-5D questionnaire is a widely used, generic questionnaire that assesses health-related quality of life and consists of a 100-milliliter (mm) visual analog scale (VAS) on which the participant rated their perceived health state on that day from 0-mm (worst imaginable health state) to 100-mm (best imaginable health state).|Week 26|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable VAS data.|||units on a scale||Standard Deviation|Mean
2653236|NCT01644474|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2653301|NCT01644331|Secondary|Fluid Loss|Change from baseline fluid balance at 24, 48, and 72 hours|0, 24, 48, and 72 hours|baseline population|||mL||Standard Deviation|Mean
2653214|NCT01644500|Secondary|European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score Responses at 26 Weeks|The EQ-5D questionnaire is a widely used, generic questionnaire that assesses 5 dimensions associated with quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 possible levels of response: no problem, some problem, and extreme problem. Additional categories of response include ambiguous and missing. The number of participants per each of the 5 response categories is summarized for each of the 5 dimensions.|Week 26|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable EQ-5D data.|||participants|||Number
2653215|NCT01644500|Secondary|Number of Participants With Adjudicated Pancreatitis|The number of adjudicated (by an independent committee of expert physicians) pancreatic events is summarized at 26 weeks. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement.|||participants|||Number
2653216|NCT01644500|Secondary|Number of Participants With Adjudicated Cardiovascular Events|Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs that were adjudicated included myocardial infarction; hospitalization for unstable angina; hospitalization for heart failure; coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention); and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement.|||number of participants|||Number
2653217|NCT01644500|Secondary|Percentage of Participants Developing Antibodies to Dulaglutide|Dulaglutide anti-drug antibodies (ADA) were assessed at baseline and 26 weeks. A participant was considered to have treatment-emergent dulaglutide ADA if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.|Baseline through 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable ADA data.|||percentage of participants|||Number
2653218|NCT01644500|Secondary|Change From Baseline in Body Mass Index (BMI) at 26 Weeks|BMI is an estimate of body fat based on body weight divided by height squared. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline body weight as covariate; and participant as a random effect.|Baseline, 26 Weeks|All participants who were randomized, received at least one dose of study drug, and had evaluable BMI data.|||kilograms per meter squared (kg/m^2)||Standard Error|Least Squares Mean
2653219|NCT01644500|Secondary|Change From Baseline in Body Weight at 26 Weeks|LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline body weight as covariate; and participant as a random effect.|Baseline, 26 Weeks|All participants who were randomized, received at least one dose of study drug, and had evaluable body weight data.|||kilogram (kg)||Standard Error|Least Squares Mean
2653220|NCT01644500|Secondary|Change From Baseline in Heart Rate From ECG at 26 Weeks||Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable ECG data.|||bpm||Standard Deviation|Mean
2653221|NCT01644500|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia Corrected QT (QTcF) Interval and P-R Wave (PR) Interval at 26 Weeks|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and R-R wave (RR), which is the interval between two R waves. PR is the interval between the P wave and the ventricular depolarization wave (QRS) complex.|Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable ECG data.|||milliseconds (msec)||Standard Deviation|Mean
2653222|NCT01644500|Secondary|Change From Baseline in Sitting Pulse Rate at 26 Weeks|LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline pulse rate as covariate; and participant as a random effect.|Baseline, 26 Weeks|All participants who were randomized, received at least one dose of study drug, and had evaluable pulse rate data.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2653223|NCT01644500|Secondary|Change From Baseline in Sitting Blood Pressure at 26 Weeks|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline blood pressure as covariate; and participant as a random effect.|Baseline, 26 Weeks|All participants who were randomized, received at least one dose of study drug, and had evaluable blood pressure data.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2653224|NCT01644500|Secondary|Change From Baseline in Serum Calcitonin at 26 Weeks||Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable serum calcitonin data.|||picomoles per liter (pmol/L)||Standard Deviation|Mean
2653225|NCT01644500|Secondary|Change From Baseline in Pancreatic Enzymes at 26 Weeks|Amylase (total and pancreas-derived) and lipase concentrations were measured.|Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement and had evaluable pancreatic enzyme data.|||units per liter (u/L)||Standard Deviation|Mean
2653237|NCT01644474|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Mean
2653226|NCT01644500|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks|Change from baseline in HOMA2-%S was assessed by using the HOMA to quantify insulin sensitivity. HOMA2-%S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. LS means were calculated using an ANCOVA model with country, baseline, pre-treatment, and treatment as fixed effects.|Baseline, up to 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. LOCF methodology was used to impute missing post-baseline values.|||percentage of HOMA2-%S||Standard Error|Least Squares Mean
2653227|NCT01644500|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β) - Cell Function (HOMA2-%B) at 26 Weeks|Change from baseline in HOMA2-%B was assessed by using the homeostasis model assessment (HOMA) to quantify β-cell function. HOMA2-%B is a computer model that uses FBG, insulin, and C-peptide concentrations to estimate steady state β-cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. LS means were calculated using an analysis of covariance (ANCOVA) model with country, baseline, pre-treatment, and treatment as fixed effects.|Baseline, up to 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. LOCF methodology was used to impute missing post-baseline values.|||percentage of HOMA2-%B||Standard Error|Least Squares Mean
2653228|NCT01644500|Secondary|Number of Participants With Self-Reported Hypoglycemic Episodes|The overall number of participants with self-reported hypoglycemic episodes is presented.|Baseline through 26 Weeks|All participants who were randomized and received at least one dose of study drug.|||participants|||Number
2653229|NCT01644500|Secondary|Rate of Hypoglycemic Episodes|Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 milligrams per deciliter (mg/dL) (≤3.9 mmol/L). A severe hypoglycemic episode was defined as any hypoglycemic event for which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Log mean rates of total hypoglycemia (per 30 days per participant) are presented and were calculated from negative binomial regression model. The model included country/region, prior medication group, treatment, visit, and treatment-by-visit interaction. The logarithm of days between visits was adjusted as an offset to account for possible unequal duration between visits and between participants.|Baseline through 26 Weeks|Participants who had been randomized, received at least one dose of study drug, and had evaluable hypoglycemic data.|||episodes/participant/30 days||Standard Deviation|Mean
2653230|NCT01644500|Secondary|Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks|Change from baseline in mean daily blood glucose (BG) values were measured with a 7-point SMBG profile. Participants recorded their 7-point SMBG profiles on 2 separate, non-consecutive days during the 2-week period immediately before randomization, Week 8, Week 16, and Week 26 (or the Early Discontinuation Visit). The 7-point SMBG profile consisted of pre-prandial BG measures before the morning (fasting), midday, and evening meals; BG measures 2 hours after the start (post-prandial) of the morning, midday, and evening meals; and BG measures at bedtime. Mean at 26 weeks was assessed in all treatment groups. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline body weight as covariate; and participant as a random effect.|Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement.|||mmol/L||Standard Error|Least Squares Mean
2653231|NCT01644500|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks|FBG is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. FBG was measured by a central laboratory. LS means were calculated using MMRM analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline FBG as covariate; and participant as a random effect.|Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2653232|NCT01644500|Secondary|Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks|Percentages of participants who achieved HbA1c levels of <7% or ≤6.5% were analyzed using a logistic regression model, controlling for treatment, pre-treatment, baseline HbA1c and country.|26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values.|||percentage of participants|||Number
2653233|NCT01644500|Primary|Change From Baseline in HbA1c at 26 Weeks|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) analysis adjusting for treatment, country, pre-study therapy stratum, visit, and treatment-by-visit as fixed effects; baseline HbA1c as covariate; and participant as a random effect.|Baseline, 26 Weeks|Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement.|||percentage of HbA1c||Standard Error|Least Squares Mean
2653234|NCT01644474|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo A-1 ITT population.|||percent change||Standard Error|Mean
2653235|NCT01644474|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on­ or off-treatment (Apo A-1 ITT population).|||percent change||Standard Error|Least Squares Mean
2653302|NCT01644331|Secondary|Weight Loss|Change in body weight from baseline to 24, 48, and 72 hours|0, 24, 48, and 72 hours|Baseline population|||lbs||Standard Deviation|Mean
2653243|NCT01644474|Secondary|Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 24|ITT population.|||percentage of participants|||Number
2653244|NCT01644474|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
2653245|NCT01644474|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2653246|NCT01644474|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Apo-B ITT population.|||percent change||Standard Error|Least Squares Mean
2653247|NCT01644474|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on­ or off-treatment (Total-C ITT population).|||percent change||Standard Error|Least Squares Mean
2653248|NCT01644474|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on­ or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2653249|NCT01644474|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on­ or off-treatment (Apo B ITT population).|||percent change||Standard Error|Least Squares Mean
2653250|NCT01644474|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.|From Baseline to Week 24|ITT population.|||percent change||Standard Error|Least Squares Mean
2653251|NCT01644474|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 24|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on­ or off-treatment.|||percent change||Standard Error|Least Squares Mean
2653252|NCT01644396|Other Pre-specified|Number of Participants With Adverse Events (AEs)|"An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment.~The investigator rated the severity of each AE as either:~Mild: The AE is transient and easily tolerated; Moderate: The AE causes the participant discomfort and interrupts usual activities.~Severe: The AE causes considerable interference with usual activities and may be incapacitating or life-threatening.~A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome.~Drug-related AEs are those assessed by the investigator as either probably or possibly related.~Other malignancy excludes lymphoma, hepatosplenic T-cell lymphoma (HSTCL), leukemia, non-melanoma skin cancer (NMSC), and melanoma."|From the first dose of study drug until 70 days after the last dose (up to 33 weeks).||||participants|||Number
2653253|NCT01644396|Other Pre-specified|Change From Baseline in Body Temperature|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||degrees celsius||Standard Deviation|Mean
2653254|NCT01644396|Other Pre-specified|Change From Baseline in Weight|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||kg||Standard Deviation|Mean
2653255|NCT01644396|Other Pre-specified|Change From Baseline in Respiratory Rate|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||respirations per minute||Standard Deviation|Mean
2653256|NCT01644396|Other Pre-specified|Change From Baseline in Pulse|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||beats per minute||Standard Deviation|Mean
2653257|NCT01644396|Other Pre-specified|Change From Baseline in Blood Pressure|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)||||mm Hg||Standard Deviation|Mean
2653303|NCT01644331|Secondary|Renal Function|Change in Serum creatinine from baseline to 24, 48 and 72 hours|0, 24, 48 and 72 hours|Baseline population|||mg/dL||Standard Deviation|Mean
2661039|NCT01574183|Primary|Percent Marijuana-negative Urine Drug Screens (UDS)|Participants submitted a urine sample weekly. Percentage of marijuana negative urine samples were calculated per group.|8 weeks||||percentage of UDS|Participants||Number
2653258|NCT01644396|Other Pre-specified|Change From Baseline in Urine Specific Gravity|Safety variables included laboratory data, vital signs and adverse events. Specific gravity is a measure of the amount of material dissolved in the urine. Specific gravity is the ratio of the density (mass of a unit volume) of a substance to the density (mass of the same unit volume) of a reference substance.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||ratio||Standard Deviation|Mean
2653259|NCT01644396|Other Pre-specified|Change From Baseline in Urine pH|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||pH units||Standard Deviation|Mean
2653260|NCT01644396|Other Pre-specified|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||mg/L||Standard Deviation|Mean
2653261|NCT01644396|Other Pre-specified|Change From Baseline in Triglycerides|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||mmol/L||Standard Deviation|Mean
2653262|NCT01644396|Other Pre-specified|Change From Baseline in Cholesterol|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||mmol/L||Standard Deviation|Mean
2653263|NCT01644396|Other Pre-specified|Change From Baseline in Total Protein|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||g/L||Standard Deviation|Mean
2653264|NCT01644396|Other Pre-specified|Change From Baseline in Albumin|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||g/L||Standard Deviation|Mean
2653265|NCT01644396|Other Pre-specified|Change From Baseline in Glucose|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||mmol/L||Standard Deviation|Mean
2653266|NCT01644396|Other Pre-specified|Change From Baseline in Calcium, Sodium and Potassium|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||mmol/L||Standard Deviation|Mean
2653267|NCT01644396|Other Pre-specified|Change From Baseline in Inorganic Phosphate|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||mmol/L||Standard Deviation|Mean
2653268|NCT01644396|Other Pre-specified|Change From Baseline in Uric Acid|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||µmol/L||Standard Deviation|Mean
2653269|NCT01644396|Other Pre-specified|Change From Baseline in Blood Urea Nitrogen (BUN)|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||mmol/L||Standard Deviation|Mean
2653270|NCT01644396|Other Pre-specified|Change From Baseline in Creatinine|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||µmol/L||Standard Deviation|Mean
2653271|NCT01644396|Other Pre-specified|Change From Baseline in Total Bilirubin|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||µmol/L||Standard Deviation|Mean
2653272|NCT01644396|Other Pre-specified|Change From Baseline in Alkaline Phosphatase|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||U/L||Standard Deviation|Mean
2653273|NCT01644396|Other Pre-specified|Change From Baseline in Aspartate Aminotransferase|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||U/L||Standard Deviation|Mean
2653274|NCT01644396|Other Pre-specified|Change From Baseline in Alanine Aminotransferase|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||U/L||Standard Deviation|Mean
2653275|NCT01644396|Other Pre-specified|Change From Baseline in Erythrocyte Sedimentation Rate|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||mm/hour||Standard Deviation|Mean
2653627|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||90min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||cm/s||Standard Deviation|Mean
2653277|NCT01644396|Secondary|Percent Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|"NAPSI grades nails for both nail matrix psoriasis and nail bed psoriasis. The most affected fingernail was determined at Baseline and used for the analysis.~Nail matrix psoriasis consists of any of the following: pitting, leukonychia, red spots in the lunula, or nail plate crumbling. Nail bed psoriasis is the presence or absence of onycholysis, splinter hemorrhages, oil drop (salman patch) discoloration or nail bed hyperkeratosis. Scoring for each is based on the following scale:~0 = none;~1 = present in 1/4 nail quadrants;~2 = present in 2/4 nail quadrants;~3 = present in 3/4 nail quadrants;~4 = present in 4/4 nail quadrants.~The sum of these two scores is the total score for the nail, and ranges from 0 (no nail psoriasis) to 8 (psoriasis in 4/4 nail quadrants). Change from Baseline is presented as a percentage of the Baseline value, calculated as: Week 24 value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement."|Baseline and Week 24|Intent-to-treat population who had a NAPSI score ≥ 0 at the Baseline visit; last observation carried forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
2653278|NCT01644396|Secondary|Percent Change From Baseline in Dermatology Life Quality Index (DLQI)|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all. Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement.|Baseline and Weeks 8, 12, and 24|Intent-to-treat population with available data; last observation carried forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
2653279|NCT01644396|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|"PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.~Change from Baseline is presented as a percentage of the Baseline value: Post-baseline value - Baseline value / Baseline value * 100. A negative change from Baseline indicates improvement."|Baseline and Weeks 2, 4, 8, 12, 16, and 24|Intent-to-treat population; last observation carried forward (LOCF) imputation was used.|||percent change||Standard Deviation|Mean
2653280|NCT01644396|Secondary|Percentage of Participants Achieving a PASI 100 Response|The percentage of participants with a 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Weeks 2, 4, 8, 12, 16, and 24|Intent-to-treat population; non-responder analysis was used.|||percentage of participants|||Number
2653281|NCT01644396|Secondary|Percentage of Participants Achieving a PASI 90 Response|The percentage of participants with a ≥ 90% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Weeks 2, 4, 8, 12, 16, and 24|Intent-to-treat population; non-responder imputation was used.|||percentage of participants|||Number
2653282|NCT01644396|Secondary|Percentage of Participants Achieving a PASI 75 Response|The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Weeks 2, 4, 8, 12, and 16|Intent-to-treat population; non-responder imputation was used.|||percentage of participants|||Number
2653283|NCT01644396|Secondary|Percentage of Participants Achieving a PASI 50 Response|The percentage of participants with a ≥ 50% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Weeks 2, 4, 8, 12, 16, and 24|Intent-to-treat population; non-responder imputation was used.|||percentage of participants|||Number
2653304|NCT01644331|Primary|Dyspnea Improvement Measured by Likert Scale at 8 and 24 Hours|The number of patients with at least moderate improvement (as reported by patient) in dyspnea Likert scale at both 8 AND 24 hours AND without the need for escalation of therapy due to worsening heart failure (rescue therapy) or death within 24 hours.|8 and 24 hours|Baseline population|||Participants|||Count of Participants
2653305|NCT01644292|Primary|Change From Baseline in Wheelchair Skills Test (WST) 4.1 Capacity Score|The WST is a structured assessment with 32 discrete mobility skills required to perform social roles in the community, each scored dichotomously as pass/fail. The WST produces a total Skill Capacity score (0-100%) reflecting the number of skills safely passed.|Baseline and follow-up (1 month)||||units on a scale||Standard Deviation|Mean
2653306|NCT01644240|Primary|CLss|Apparent clearance|Day 5||||L/hr||Standard Deviation|Mean
2653284|NCT01644396|Secondary|Percentage of Participants Achieving a One Grade Improvement in Physician's Global Assessment (PGA)|"The PGA is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;~1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;~2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;~3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;~4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;~5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.~The percentage of participants achieving a shift from Baseline to a less severe category is reported."|Baseline and Weeks 2, 4, 8, 12, 16 and 24|Intent-to-treat population; non-responder imputation was used.|||percentage of participants|||Number
2653285|NCT01644396|Secondary|Percentage of Participants Achieving a Physician's Global Assessment of Clear or Minimal|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;~1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;~2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;~3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;~4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;~5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.~The percentage of participants achieving a PGA score of clear (0) or minimal (1) is reported."|Weeks 2, 4, 8, 12, 16 and 24|Intent-to-treat population; non-responder imputation was used.|||percentage of participants|||Number
2653286|NCT01644396|Secondary|Percentage of Participants Achieving a Physician's Global Assessment of Clear|"The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was evaluated using the following categories:~0: No evidence of scaling, erythema, or plaque elevation, overall score of cleared;~1: Occasional fine scale over <5% of lesions, faint erythema, minimal plaque elevation, overall score of minimal;~2: Fine scale dominates, light red coloration, mild plaque elevation, overall score of mild;~3: Course scale dominates, moderate red coloration, moderate plaque elevation, overall score of moderate;~4: Thick non-tenacious scale dominates, bright red coloration, marked plaque elevation, overall score of marked;~5: Very thick tenacious scale predominates, dusky to deep red coloration, severe plaque elevation, overall score of severe.~The percentage of participants achieving a PGA score of clear (0) is reported."|Weeks 2, 4, 8, 12, 16 and 24|Intent-to-treat population; non-responder imputation was used.|||percentage of participants|||Number
2653287|NCT01644396|Other Pre-specified|Change From Baseline in Red Blood Cell Count|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||× 10^12 cells/L||Standard Deviation|Mean
2653288|NCT01644396|Other Pre-specified|Change From Baseline in Hematocrit|Safety variables included laboratory data, vital signs and adverse events. The hematocrit measures the volume of red blood cells compared to the total blood volume (red blood cells and plasma).|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||liters/liter||Standard Deviation|Mean
2653289|NCT01644396|Other Pre-specified|Change From Baseline in Hemoglobin|Safety variables included laboratory data, vital signs and adverse events.|Baseline and Week 24 (or Early Termination Visit)|Intent-to-treat population; participants with non-missing Baseline and at least 1 post-baseline observation are included in the analysis.|||g/L||Standard Deviation|Mean
2653290|NCT01644396|Primary|Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 24|The percentage of participants with a ≥ 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score from Baseline. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline and Week 24|Intent-to-treat population; non-responder imputation (NRI) was used, where participants with a missing value were counted as a non-responders.|||percentage of participants|||Number
2653291|NCT01644331|Secondary|All Cause Death or Rehospitalization|All cause death or rehospitalization (to include unscheduled clinic visits or ED visits) at 30 days (Kaplan-Meier and 95% confidence interval)|30 days|baseline population|||proportion of participants||95% Confidence Interval|Mean
2653292|NCT01644331|Secondary|Days Hospitalized or Deceased|Total days hospitalized or deceased during the 30 days after randomization|30 days|baseline population|||days||Standard Deviation|Mean
2653293|NCT01644331|Secondary|Development of Worsening Renal Function|increase in serum creatinine ≥ 0.3mg/dl from randomization at any time point during 72 hours after randomization|72 hours|baseline population|||Participants|||Count of Participants
2653294|NCT01644331|Secondary|Freedom From Congestion|Jugular Venous Pressure (JVP) < 8 cm, no orthopnea, trace peripheral edema or less, and will be assessed at 24, 48, and 72 hours|24, 48, and 72 hours|baseline population|||Participants|||Count of Participants
2653295|NCT01644331|Secondary|Dyspnea 11 Point NRS|Change in NRS for assessment of dyspnea from baseline to 24, 48, and 72 hours (scale ranges from 0-No difficulty breathing to 10-Difficulty as bad as you can imagine)|0, 24, 48, and 72 hours|baseline population|||units on a scale||Standard Deviation|Mean
2653296|NCT01644331|Secondary|Serum Sodium|Change in serum sodium from baseline to 24, 48, and 72 hours|0, 24, 48, and 72 hours|baseline population|||mmol/L||Standard Deviation|Mean
2653297|NCT01644331|Secondary|Over-diuresis|clinical evidence of volume depletion requiring intervention other than holding diuretics during the 72 hours after randomization|72 hours|baseline population|||Participants|||Count of Participants
2653323|NCT01644188|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 104 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 104 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 104 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 104|mITT population.|||Percent change||Standard Error|Least Squares Mean
2653324|NCT01644188|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 104 - ITT Analysis|Adjusted LS means and standard errors at Week 104 from MMRM including all available post-baseline data from Week 4 to Week 104 regardless of status on-or off-treatment.|From Baseline to Week 104|ITT population.|||Percent change||Standard Error|Least Squares Mean
2653325|NCT01644188|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 52|mITT population.|||Percent change||Standard Error|Least Squares Mean
2653326|NCT01644188|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.|||percent change||Standard Error|Least Squares Mean
2653327|NCT01644188|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2653328|NCT01644188|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2653329|NCT01644188|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2653330|NCT01644188|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).|||percent change||Standard Error|Least Squares Mean
2653331|NCT01644188|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2653332|NCT01644188|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2653333|NCT01644188|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|From baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2653334|NCT01644188|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from week 4 to week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|Up to Week 52|mITT population.|||percentage of participants|||Number
2653335|NCT01644188|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.|||percentage of participants|||Number
2653336|NCT01644188|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from a MMRM model including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
2653337|NCT01644188|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Total-C ITT population|||percent change||Standard Error|Least Squares Mean
2653338|NCT01644188|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2653339|NCT01644188|Secondary|Percent Change From Baseline in Apo-B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo-B ITT population.|||percent change||Standard Error|Least Squares Mean
2653628|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||60min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||cm/s||Standard Deviation|Mean
2653340|NCT01644188|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).|||percent change||Standard Error|Least Squares Mean
2653341|NCT01644188|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline up to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).|||percent change||Standard Error|Least Squares Mean
2653342|NCT01644188|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2653343|NCT01644188|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo-B mITT population).|||percent change||Standard Error|Least Squares Mean
2653344|NCT01644188|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo-B value on-or off-treatment (Apo-B ITT population).|||percent change||Standard Error|Least Squares Mean
2653345|NCT01644188|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 52|mITT population.|||percent change||Standard Error|Least Squares Mean
2653346|NCT01644188|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from a MMRM including all available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
2653347|NCT01644188|Secondary|Percent Change From Baseline in Calculated LDL--C at Week 24 - On--Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first).|From Baseline to Week 52|Modified ITT population (mITT): all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2653348|NCT01644188|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from week 4 to week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2653349|NCT01644175|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.|||percent change||Standard Error|Least Squares Mean
2653350|NCT01644175|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by a robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2653351|NCT01644175|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2653352|NCT01644175|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 12- ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2653353|NCT01644175|Secondary|Percent Change From Baseline in Apolipoprotein A-1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).|||percent change||Standard Error|Least Squares Mean
2653354|NCT01644175|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed be robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2657192|NCT01607853|Secondary|Change From Baseline in Infiltration at Day 4|Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 4||||units on a scale||Standard Deviation|Mean
2653355|NCT01644175|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2653356|NCT01644175|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|From baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2653357|NCT01644175|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.|||percentage of participants|||Number
2653358|NCT01644175|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.|||percentage of participants|||Number
2653359|NCT01644175|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
2653360|NCT01644175|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
2653361|NCT01644175|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2653362|NCT01644175|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
2653363|NCT01644175|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).|||percent change||Standard Error|Least Squares Mean
2653364|NCT01644175|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).|||percent change||Standard Error|Least Squares Mean
2653365|NCT01644175|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2653366|NCT01644175|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo B mITT population).|||percent change||Standard Error|Least Squares Mean
2653367|NCT01644175|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).|||percent change||Standard Error|Least Squares Mean
2653368|NCT01644175|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.|||percent change||Standard Error|Least Squares Mean
2653369|NCT01644175|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
2653370|NCT01644175|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2662673|NCT01560260|Secondary|Failure-free Survival|Analyzed using Kaplan-Meier curves for the all treated and per protocol populations|Up to 37 weeks|Data was not collected for this outcome measure due to limited activity seen with the study treatment.||||||
2653371|NCT01644175|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2653372|NCT01644149|Secondary|Percentage of Subjects With Solicited Local or Systemic Adverse Events|Vaccine reactogenicity will be collected on a patient-completed diary card daily for seven days post-vaccination. The following adverse events will be solicited on the diary card: injection site tenderness, injection site pain, injection site redness, injection site swelling, injection site itching, injection site bruising, fatigue, muscle aches, headache, decreased appetite, fever, pruritus.|4 days|Data included in the analysis were collected on a 4-Day Diary Card from the safety population and grade >1.|||Percentage of Subjects|||Number
2653373|NCT01644149|Primary|The Percentage of Participants Achieving Seroconversion|Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (<1:10), attainment of a post-immunization titer of ≥1:40.|28 days|Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in the Immunogenicity Population.|||Percentage of Subjects Seroconverted|||Number
2653374|NCT01644149|Primary|Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)|The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio (GMT with Needle-Free / GMT with Needle and Syringe) antigen will not exceed 1.5 fold.|28 days|The immunogenicity analyses were conducted using data from subjects in the immunogenicity population.|||Titers||Standard Deviation|Geometric Mean
2653375|NCT01644058|Primary|Oral-health-related Quality of Life With the Immediate Loading Protocol|Oral Health Impact Profile (OHIP-20) to assess oral-health-related quality of life: score ranges between 20 and 120 points, with a lower score indicating a better oral-health-related quality of life.|4 months||||units on a scale||Standard Deviation|Mean
2653376|NCT01644058|Primary|Patient Satisfaction With the Immediate Loading Protocol|Visual Analogue Scale (VAS) to assess patients' satisfaction, with a score of 100 being extremely satisfied (minimum and maximum scores: 1-100 respectively).|4 months||||millimeters||Standard Deviation|Mean
2653377|NCT01643928|Primary|Outcome Measure Using HAQ-DI - by the End of Course 3|"HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.~Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.~Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3."|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Score on a scale||Standard Deviation|Mean
2653378|NCT01643928|Primary|Outcome Measure Using HAQ-DI - by the End of Course 2|"HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.~Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.~Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3."|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Score on a scale||Standard Deviation|Mean
2653379|NCT01643928|Primary|Outcome Measure Using HAQ-DI - by the End of Course 1|"HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.~Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.~Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3."|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Score on a scale||Standard Deviation|Mean
2653387|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2|"Participants were asked the following question, Considering all the ways your arthritis affects you, how are you feeling today? Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor)."|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percent change in score||Standard Deviation|Mean
2657193|NCT01607853|Secondary|Change From Baseline in Erythema at Day 22|Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 22||||units on a scale||Standard Deviation|Mean
2653380|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3|"HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.~Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.~Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale."|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percent change in score||Standard Deviation|Mean
2653381|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2|"HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.~Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.~Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale."|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percent change in score||Standard Deviation|Mean
2653382|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1|"HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible.~Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.~Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale."|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percent change in score||Standard Deviation|Mean
2653383|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3|The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percent change in score||Standard Deviation|Mean
2653384|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2|The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percent change in score||Standard Deviation|Mean
2653385|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1|The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percent change in score||Standard Deviation|Mean
2653386|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3|"Participants were asked the following question, Considering all the ways your arthritis affects you, how are you feeling today? Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor)."|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percent change in score||Standard Deviation|Mean
2662674|NCT01560260|Secondary|Response Duration|Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.|Up to 37 weeks|No responses were observed.||||||
2653388|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1|"Participants were asked the following question, Considering all the ways your arthritis affects you, how are you feeling today? Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor)."|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percent change in score||Standard Deviation|Mean
2653389|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percent change in score||Standard Deviation|Mean
2653390|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percent change in score||Standard Deviation|Mean
2653391|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1|Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percent change in score||Standard Deviation|Mean
2653392|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3|Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.|Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percent change in joint count||Standard Deviation|Mean
2653393|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2|Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.|Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percent change in joint count||Standard Deviation|Mean
2653394|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1|Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.|Screening, Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percent change in joint count||Standard Deviation|Mean
2653395|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3|Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.|Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percent change in joint count||Standard Deviation|Mean
2653396|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2|Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.|Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percent change in joint count||Standard Deviation|Mean
2653424|NCT01643928|Primary|Mean Rituximab Serum Trough Concentrations|Serum samples for determination of drug concentrations were collected pre-dose concurrent with ADA sample collection. Drug concentrations in the samples were determined using a validated assay.|Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3), Follow up Months 3, 6, 9, and 12. Course 3/Week 25 is End of Treatment (EOT).|mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.|||nanograms per milliliter||Standard Deviation|Mean
2653397|NCT01643928|Primary|Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1|Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.|Screening, Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percent change in joint count||Standard Deviation|Mean
2653398|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3|ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percentage of Participants|||Number
2653399|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2|ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percentage of Participants|||Number
2653400|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1|ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percentage of Participants|||Number
2653401|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3|ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percentage of Participants|||Number
2653402|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2|ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percentage of Participants|||Number
2653403|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1|ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percentage of Participants|||Number
2653404|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3|ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percentage of participants|||Number
2653405|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2|ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percentage of participants|||Number
2653425|NCT01643928|Primary|Percentage of Participants by Nab Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay Using Anti-Rituximab NAb Assay|Blood samples that were confirmed as positive for ADA were further evaluated for Nab using validated assays. - None of the ADA samples tested positive for NAb.|Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).|mITT Population. Only participants with a positive ADA status were included in the analysis.||||||
2653406|NCT01643928|Primary|Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1|ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and CRP.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percentage of participants|||Number
2653407|NCT01643928|Primary|Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3|The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission.|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percentage of Participants|||Number
2653408|NCT01643928|Primary|Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2|The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percentage of Participants|||Number
2653409|NCT01643928|Primary|Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1|The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percentage of Participants|||Number
2653410|NCT01643928|Primary|Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3|The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.|Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percentage of Participants|||Number
2653411|NCT01643928|Primary|Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2|The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percentage of Participants|||Number
2653412|NCT01643928|Primary|Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1|The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP [mg/L] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percentage of Participants|||Number
2653413|NCT01643928|Primary|Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline >0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline >0.6 with present DAS28 >3.2 and ≤5.1 or change from baseline >1.2 with present DAS28 >5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 >5.1.|Week 1, 6, 13, and 25 (Course 1 and Course 2) and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Percentage of Participants|||Number
2653414|NCT01643928|Primary|Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline >0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline >0.6 with present DAS28 >3.2 and ≤5.1 or change from baseline >1.2 with present DAS28 >5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 >5.1.|Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Percentage of Participants|||Number
2653415|NCT01643928|Primary|Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline >0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline >0.6 with present DAS28 >3.2 and ≤5.1 or change from baseline >1.2 with present DAS28 >5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 >5.1.|Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Percentage of Participants|||Number
2653416|NCT01643928|Primary|Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3|The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log [ln] (CRP [milligrams per liter, mg/L] +1) + 0.014 (global assessment of health [GH]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.|Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).|mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.|||Units on a scale||Standard Deviation|Mean
2653417|NCT01643928|Primary|Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2|The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log [ln] (CRP [milligrams per liter, mg/L] +1) + 0.014 (global assessment of health [GH]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.|Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2).|mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.|||Units on a scale||Standard Deviation|Mean
2653418|NCT01643928|Primary|Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1|The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log [ln] (CRP [milligrams per liter, mg/L] +1) + 0.014 (global assessment of health [GH]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.|Baseline B3281001, Week 1, 6, 13, and 25 (Course 1).|mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.|||Units on a scale||Standard Deviation|Mean
2653419|NCT01643928|Primary|Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement|Blood samples were obtained to determine anti-CCP and compliment levels in serum.|Week 1 and 25 (Course 1, Course 2, and Course 3).|mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.|||U/mL||Standard Deviation|Mean
2653420|NCT01643928|Primary|Circulating Rheumatoid Factor (RF) Concentrations|RF is the auto-antibody directed against IgG. Blood samples were obtained to determine RF levels in serum.|Week 1 and 25 (Course 1, Course 2, and Course 3).|mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.|||international units per milliliter||Standard Deviation|Mean
2653421|NCT01643928|Primary|Circulating Immunoglobulin M (IgM) Concentrations|Blood samples for immunoglobulin assessments were obtained to determine IgM levels in serum.|Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).|mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.|||g/L||Standard Deviation|Mean
2653422|NCT01643928|Primary|Circulating Immunoglobulin G (IgG) Concentrations|Blood samples for immunoglobulin assessments were obtained to determine IgG levels in serum.|Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).|mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.|||grams per liter (g/L)||Standard Deviation|Mean
2653423|NCT01643928|Primary|Cluster of Differentiation 19 (CD19+) B Cell Count|Blood samples were assayed for CD19+ B-cell counts using laser scanning cytometry.|Weeks 1, 6, 13, and 25 (Course 1 and Course 2), Weeks 1, 13, 25 (Course 3), and Follow up Months 3, 6, and 9.|mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.|||cells per microliter||Full Range|Median
2653426|NCT01643928|Primary|Percentage of Participants by Neutralizing Antibody (Nab) Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay|Blood samples that were confirmed as positive for ADA were further evaluated for Nab using validated assays - None of the ADA samples tested positive for NAb.|Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).|mITT Population. Only participants with a positive ADA status were included in the analysis.||||||
2653427|NCT01643928|Primary|Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay|Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586.|Course 1 Overall, Course 2 Overall, Course 3 Overall, and All Courses Overall.|mITT population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively. Only participants with a positive ADA status were included in the analysis.|||Percentage of Participants|||Number
2653428|NCT01643928|Primary|Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay|Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive (+ve) for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586.|Course 1 (C1) Overall, Course 2 (C2) Overall, Course 3 (C3) Overall, and All Courses Overall.|Modified intent-to-treat (mITT) population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively. Only participants with a positive ADA status were included in the analysis.|||Percentage of Participants|||Number
2653429|NCT01643902|Secondary|Functional Outcome by the Modified Rankin Scale at 90 Days|"The modified Rankin scale (mRS) is a scale of disability after stroke, with a range of 0 to 6.~0, no symptoms at all.~no significant disability despite symptoms; able to carry out all usual duties and activities.~slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance.~moderate disability; requiring some help, but able to walk without assistance.~moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance.~severe disability; bedridden, incontinent and requiring constant nursing care and attention.~dead."|90 days||||units on a scale||Full Range|Mean
2653430|NCT01643902|Primary|Number of Participants With Symptomatic Intracerebral Hemorrhage Within 36 Hours of Treatment|"Symptomatic intracerebral hemorrhage by using the European Cooperative Acute Stroke Study (ECASS) 3 criteria as well as the original National Institutes of Neurological Disorders and Stroke (NINDS) Intravenous tissue plasminogen activator (IV tPA) trial criteria for comparison.~ECASS 3 criteria: hemorrhage in brain imaging, and an increase of 4 or more points on the National Institutes of Health Stroke Scale (NIHSS) from baseline.~NINDS IV tPA trial criteria: a hemorrhage not seen in previous brain imaging, associated with a neurological decline attributable to the hemorrhage."|within 36 hours of treatment|No symptomatic intracerebral hemorrhage was observed by either NINDS IV tPA trial or ECASS 3 criteria.|||participants|||Number
2653431|NCT01643876|Secondary|Candida Species Count|Candida colony forming units (CFU), defined as the number of colonies formed on a 75 mm agar plate inoculated with collected samples obtained from A)plaque formed on denture surface and B)palatal mucosa.|3 months||||colony forming units (CFUs)||Full Range|Median
2653432|NCT01643876|Primary|Palatal Inflammation|"Modified Newton classification 0: Healthy mucosa~1: Type IA, Petechiae in a normal palatal tissue, which are usually found around the orifices of the ducts of the palatal mucous glands 2: Type IB, Localized area of inflammation of the denture-bearing area 3: Type II, Generalised area of inflammation of the denture-bearing area 4: Type III, Hyperplasic palatal surface with inflammation of the denture-bearing area Inflammation area index 0: No inflammation~Inflammation of the palate extending up to 25 % of the palatal denture-bearing tissue~Inflammation of the palate extending between 25 % and 50 % of the palatal denture-bearing tissue~Inflammation covering more than 50 % of the palatal denture-bearing tissue Inflammation severity index~0: Normal tissue~Mild inflammation~Moderate inflammation~Severe inflammation Total score for inflammation = area + intensity (range 0 to 6)"|3 months||||units on a scale||Full Range|Median
2653433|NCT01643850|Secondary|Change From Baseline Per Treatment Using EuroQol-5 Dimensional (EQ-5D VAS)Visual Analog Scale Quality of Life Questionnaire|The EQ-5D is a standardized measure of health status. The EQ visual analogue scale (EQ VAS)has a range from 0-100: worst possible to perfect health. Data show the absolute change from baseline of EQ5D VAS and at the different visits for participants, who received multiple doses of MCS110. (PART B and PART C).|Week 4, Week 24, up to 104 weeks|Pharmacodynamic analysis set|||Score on a scale||Standard Deviation|Mean
2653434|NCT01643850|Secondary|Change From Baseline Per Treatment for Symptoms in the Knee Injury and Osteoarthritis Outcome Score (KOOS)|The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.|Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study)|Pharmacodynamic analysis set|||Score on a scale||Standard Deviation|Mean
2653435|NCT01643850|Secondary|Change From Baseline Per Treatment for Sport/Recreation in the Knee Injury and Osteoarthritis Outcome Score (KOOS)|The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.|Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study)|Pharmacodynamic analysis set|||Score on a scale||Standard Deviation|Mean
2653436|NCT01643850|Secondary|Change From Baseline Per Treatment for Pain and Discomfort in the Knee Injury and Osteoarthritis Outcome Score (KOOS)|The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.|Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study)|Pharmacodynamic analysis set|||Score on a scale||Standard Deviation|Mean
2653437|NCT01643850|Secondary|Change From Baseline Per Treatment for Knee Related Quality of Life in the Knee Injury and Osteoarthritis Outcome Score (KOOS)|The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.|Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study)|Pharmacodynamic analysis set|||Score on a scale||Standard Deviation|Mean
2653438|NCT01643850|Secondary|Change From Baseline Per Treatment for Activities of Daily Living (ADL) in the Knee Injury and Osteoarthritis Outcome Score (KOOS)|The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life (QOL), pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.|Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study)|Pharmacodynamic analysis set|||Score on a scale||Standard Deviation|Mean
2653439|NCT01643850|Secondary|Number of CD14+ Monocytes and Number of CD14 + Monocytes and CD16+ Monocytes|Blood samples were collected for the evaluation of CD14+ monocytes (using FACS) and CD14+ CD16+ monocytes. Based on preliminary analysis, the quality of the samples did not allow meaningful conclusions to be drawn. Thus, in Part B, the monocyte sample collection was discontinued.|Baseline Up to Week 104|Pharmacodynamic analysis set|||Number of Monocytes|||Number
2653440|NCT01643850|Secondary|Average of Health-Related Quality of Life Questionnaire Score for mHAQ|The mHAQ assesses 20 activities in 8 categories related to daily life, which are rated on a 4-point Likert scale. The mHAQ is calculated as the average of the single scores with the following scoring: without difficulty =0; with some difficulty =1; with much difficulty =2; unable to do =3. Total score is between 0 - 3.0. Values <0.3 are considered normal. Data presented include only participants, who received multiple doses of MCS110.|up to 104 weeks|Pharmacodynamic analysis set|||Scores on a scale||Standard Deviation|Mean
2653441|NCT01643850|Secondary|Time to Surgery|Time to surgery describes the time frame from baseline to the time point when participants had surgical removement of PVNS tumor. This could be either residual tumor after the tumor volume was reduced or surgery due to relapse. In this assessment the Part B and Part C patients were analyzed separately. Not Available (NA): Data analysis not performed as sample size was not analyzable as no patient had surgery.|Up to Week 104|Pharmacodynamic analysis set|||Days||Standard Deviation|Mean
2653442|NCT01643850|Secondary|Time to Relapse|Time to relapse describes the time frame from baseline when the tumor volume increases again after the treatment with MCS110. To be considered a relapse tumor volume had to increase greater than 50% of the difference between tumor volume at baseline and the lowest tumor volume measured by MRI. In this assessment the Part B and Part C patients were analyzed separately. N/A (not available):Data analysis not performed as sample size was not analyzable as no patient had surgery/relapse.|Up to Week 104|Pharmacodynamic analysis set|||Days||Standard Deviation|Mean
2653443|NCT01643850|Secondary|Change From Baseline in Joint Pain Using a Visual Analog Scale (VAS)|"Measurement of the participant's pain with a 100 mm visual analog scale (VAS) following treatment with MCS110 3, 5, or 10 mg/kg evaluated. Data presented are changes from baseline in degree. Participants were asked to place a line perpendicular to the VAS line at the point that represented her/his pain intensity. Using a ruler, the score was determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the participants mark, providing a score from 0-100. Analysis includes data from participants with knee tumor who received at least 2 doses of MCS110 and thus includes only patients from Part B and C of the study, thus the data set is called Part BC. The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg]."|Baseline, Week 4, Week 12, Week 24, Week 28, Week 40, Week 48, Week 104|Pharmacodynamic analysis set|||millimeters (mm)||Standard Deviation|Mean
2653444|NCT01643850|Secondary|Assessment of Change From Baseline in Joint Range of Motion for Knee Extension and Flexion|"To assess the clinical response of joint range of motion following multiple dose treatment with MCS110 3, 5, or 10 mg/kg evaluated in participants with knee tumor, which was the majority of participants (75%). The data presented are changes from baseline in degree. Participants, who started treatment with a low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and the tumor volume reduction was ≤ 45%. This analysis includes data from participants with knee tumor who received at least 2 doses of MCS110 and thus includes only patients from Part B and C of the study, thus the data set is called Part BC. The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg]."|Week 24/28, Week 104|Pharmacodynamic analysis set|||Degree||Standard Deviation|Mean
2653445|NCT01643850|Secondary|Assessment of Change From Baseline in Joint Range of Motion for Knee Extension and Flexion|"To assess the clinical response of joint range of motion following a single i.v. dose of MCS110 or placebo as compared to baseline 4 weeks post-dose evaluated in participants, who had a knee tumor, which was the majority of participants (75%). The analysis includes all data from patients 4 weeks after receiving the first dose of MCS110 (3, 5 or 10 mg/kg) or placebo. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data set is called ABC4."|Week 4|Pharmacodynamic Analysis Set|||Degree||Standard Deviation|Mean
2653446|NCT01643850|Secondary|Number of Participants With Negative Anti-MCS110 Antibody|To assess the immunogenicity of MCS110 in serum anti-MCS110 antibody concentrations|Baseline, throughout the study up to Day 505|Safety analysis set|||Number of Participants|||Number
2653447|NCT01643850|Secondary|Change in Serum C-terminal Type 1 Collagen Peptide Concentrations (CTX-I).|Pharmacodynamic characterization of a single dose of MCS110 by measuring C-terminal telopeptide of Type 1 Collagen peptide (CTX-I), a biomarker of bone resorption. Data measured in participants from three arms: participants from Part A, B and C who received a single dose of 10 mg/kg and had assessment at week 4 (Part ABC4); participants from Part A and B who received placebo ; and participants from Part B and C who received multiple monthly doses of MCS110 (10 mg/kg.) Serum CTX-I data were generated in Part A and Part B. In Part C, samples were collected for serum bone CTX-I analysis. The analysis was not performed, as enough information on compound mode of action was obtained using creatine kinase (CK) and monocytes (hematology) data. Only data from 10mg/kg (single and multiple doses) are available.|Baseline, Week 4, Week 24, Week 104|Pharmacodynamic analysis|||ng/mL||Full Range|Median
2653448|NCT01643850|Secondary|Change in Macrophage-colony Stimulating Factor (M-CSF) Plasma Concentrations Over Time|Pharmacokinetic characterization of a single dose of MCS110 for evaluation of macrophage-colony stimulating factor (M-CSF) plasma concentrations over time|Baseline, Day 1, Day 85, Day 169|Pharmacokinetic Analysis Set|||pg/mL||Standard Deviation|Mean
2653449|NCT01643850|Secondary|Pharmacokinetics of MCS110 Total Maximum Concentration (Tmax)|Pharmacokinetic characterization of a single dose of MCS110 for time to maximum concentration (Tmax)|Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr)|Pharmacokinetic Analysis Set|||hour (h)||Full Range|Median
2653450|NCT01643850|Secondary|Pharmacokinetics of MCS110 Maximum Concentration (Cmax)|Pharmacokinetic characterization of a single dose of MCS110 for maximum serum concentration (Cmax)|Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr)|Pharmacokinetic Analysis Set|||ng/mL||Standard Deviation|Mean
2653451|NCT01643850|Secondary|Pharmacokinetics of MCS110 Area Under the Serum Concentration-time Curve (AUC)|Pharmacokinetic for a single dose of MCS110 for serum concentration -time curve (AUC).|Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr)|Pharmacokinetic Analysis Set|||h* ng/mL||Standard Deviation|Mean
2653452|NCT01643850|Primary|Number of Participants With Adverse Events|Overall incidence of Adverse Events|Approximately 2 years|Safety Analysis Set|||Participants|||Count of Participants
2653453|NCT01643850|Primary|Percentage Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size|"To assess the maximum efficacy of multiple monthly i.v. doses (2 to 6) of 3, 5 or 10 mg/kg MCS110 or 3 and 10 mg/kg or 5 and 10 mg/kg by percent change in the PVNS tumor volume (as compared to baseline) up to 8 weeks post last dose evaluated by MRI. Subjects starting treatment with a low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and the tumor volume reduction was ≤ 45%. This analysis includes data from all participants who received at least 2 doses of MCS110 and thus includes only patients from Part B and C of the study, thus the data set is called Part BC. The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg]."|Up to 8 weeks post last dose|Pharmacodynamic Analysis Set|||Percentage||Standard Deviation|Mean
2653454|NCT01643850|Primary|Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size|Assessment of maximum efficacy (multiple i.v.monthly doses (2 to 6) of 3, 5 or 10 mg/kg MCS110 or 3 & 10 mg/kg or 5 & 10 mg/kg in changing PVNS tumor volume (as compared to baseline) up to 8 weeks post last dose evaluated by MRI. Analysis included data starting from 1st dose of MCS110 in all treatment groups of Parts B and C. Part B patients who received placebo as 1st dose, measurement prior to receiving first dose of MCS110, was used as baseline and assessment time-points were adjusted accordingly. For Part C, participants starting treatment with low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and tumor volume reduction was ≤ 45%. Analysis includes data from patients who received at least 2 doses. The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg]|Up to 8 weeks post last dose|Pharmacodynamic Analysis Set|||mm3||Standard Deviation|Mean
2653471|NCT01643772|Primary|Clearance Rate for Participants Who Received a Single Dose|To calculate CL of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.|blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.|PP popuplation|||L*hour||Standard Deviation|Mean
2653455|NCT01643850|Primary|Percent Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size|"To assess the efficacy of a single i.v. dose of MCS110 in percent change of the PVNS tumor volume at week 4 as compared to baseline and compared to placebo evaluated by volume of PVNS tumors by 3-dimensional MRI. This analysis includes all data from patients who received at least a single dose of MCS110 (3, 5 or 10 mg/kg) or placebo and assesses the tumor volume changes at week 4 as compared to baseline. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data set is called ABC4."|Week 4|Pharmacodynamic Analysis Set|||Percentage||Standard Deviation|Mean
2653456|NCT01643850|Primary|Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size|"To assess the efficacy of a single i.v. dose of MCS110 in changing the size of PVNS tumors (as compared to baseline) compared to placebo over 4 weeks evaluated by volume of PVNS tumors by 3-dimensional MRI. This analysis includes all data from patients 4 weeks after receiving the first dose of MCS110 (3, 5 or 10 mg/kg) or placebo and assesses the tumor volume changes at week 4 as compared to baseline. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data set is called ABC4."|Week 4|Pharmacodynamic Analysis Set|||mm3||Standard Deviation|Mean
2653457|NCT01643798|Primary|Change in BOLD Signal in Pain Processing Regions During Pain, Including Supraspinal Opioidergic Structures|There are two experimental visits separated by one week. During each experiment, blood oxygen level dependent (BOLD) signal will be measured at baseline (60 minutes into the experiment), post-sham rTMS (90 minutes into the experiment) and post-real (120 minutes into the experiment).|Baseline (60 minutes into experiment), Post-Sham (90 minutes), Post-Real (120 minutes)||||mean percentage of BOLD signal change||Standard Error|Mean
2653458|NCT01643798|Primary|Pain Rating|"There are two experimental visits separated by one week. During each experiment, pain ratings will be measured every 30 minutes. Preliminary testing will be done 30 minutes into the experiment. The purpose of preliminary testing is to select the temperature that will be used to induce pain throughout the experiment. Baseline testing will be done 60 minutes into the experiment. After sham rTMS will be done 90 minutes into the experiment. After real rTMS will be done 120 minutes into the study. The pain scale used in a Visual Analog Scale (VAS). There was an 11-point rating system where 0 represented no pain and 10 represented unbearable pain."|Baseline (60 minutes into experiment), Post-Sham (90 minutes), Post-Real (120 minutes)||||units on a scale||Standard Error|Mean
2653459|NCT01643772|Primary|Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Mutilple Dose)|Cumulative excretion of drugs were calculated according to the concentration and volume of drugs in urine after multiple dose on the 4th day .|post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day||||μg||Standard Deviation|Mean
2653460|NCT01643772|Primary|The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Multiple Dose)|The excretion of drugs were calculated according to the concentration and volume of drugs in urine after multiple dose on the 4th day.|Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h on the 4th day||||μg||Standard Deviation|Mean
2653461|NCT01643772|Primary|Average Cumulative Excretion Rate of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)|Average cumulative excretion rate of drugs were calculated according to the concentration and volume of drugs in urine after single dose.|post dose 24h||||% of ug||Standard Deviation|Mean
2653462|NCT01643772|Primary|Cumulative Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)|Cumulative excretion of drugs were calculated according to the concentration and volume of drugs in urine after single dose.|post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h||||μg||Standard Deviation|Mean
2653463|NCT01643772|Primary|The Excretion of Oxycondone, Noroxycodone, Hydroxymorphine,Normethoxymorphone in Urine(Single Dose)|The excretion of drugs were calculated according to the concentration and volume of drugs in urine after single dose.|Pre-dose,post dose0-2h,post dose2-4h,post dose4-8h,post dose8-12h,post dose12-24h||||μg||Standard Deviation|Mean
2653464|NCT01643772|Primary|Fluctuation Index (DF) for Participants Who Received Multiple Dose|To calculate Fluctuation index (DF) of Drug Valley and Peak Concentration of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.|Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.|multiple dose group has 14 subjects|||ng/ml||Standard Deviation|Mean
2653465|NCT01643772|Primary|CL for Participants Who Received Multiple Dose|To calculate Clearance rate (CL) of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.|Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.|multiple dose group has 14 subjects|||L*hour||Standard Deviation|Mean
2653466|NCT01643772|Primary|Tmax,t1/2 for Participants Who Received Multiple Dose|To calculate Tmax,t1/2 of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.|Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.|multiple dose group has 14 subjects|||hour||Standard Deviation|Mean
2653467|NCT01643772|Primary|Css_min,Css_max and Css_av for Participants Who Received Multiple Dose|To calculate Css_min,Css_max and Css_av of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.|Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.|multiple dose group has 14 subjects|||ng/ml||Standard Deviation|Mean
2653468|NCT01643772|Primary|AUCss for Participants Who Received Multiple Dose|To calculate AUCss of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in multiple dose 10mg.|Predose for the 1st, 2nd, 3rd day and predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24 post dose on the 4th day.|PP population|||ng*hours*mL||Standard Deviation|Mean
2653469|NCT01643772|Primary|ke for Participants Who Received a Single Dose|To calculate Terminal Elimination Rate (ke) of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.|blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.|PP population|||h^-1||Standard Deviation|Mean
2653470|NCT01643772|Primary|Vd for Participants Who Received a Single Dose|To calculate Apparent Distribution Volume (Vd) Vd of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method in single dose 5mg,10mg,20mg.|blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.|PP population|||L||Standard Deviation|Mean
2653474|NCT01643772|Primary|AUC0-t and AUC0-∞ for Participants Who Received a Single Dose|To calculate AUC0-t AUC0-∞of Oxycondone,Noroxycodone,Hydroxymorphine, Normethoxymorphone with Non-atrioventricular model method.Plasma concentrations of Oxycodone Hydrochloride single dose 5mg,10mg,20mg will be analyzed.|blood sample at predose,15min,30min,45min,1,1.5,2,3,4,6,8,12,24hr post-dose.|PP Population|||ng*hr*ml||Standard Deviation|Mean
2653475|NCT01643668|Secondary|Infection-related Complications|The number of patients with infection-related complications|2 years||||Participants|||Count of Participants
2653476|NCT01643668|Secondary|Grade 3 or 4 Toxicities|The number of participants that experienced the specified grade 3 and 4 non-hematological toxicities during treatment and follow-up as assessed by Common Terminology Criteria for Adverse Events version 4(CTAE v 4.0). Grade 3 toxicity is considered to be severe and grade 4 is considered to be life threatening.|2 years||||Participants|||Count of Participants
2653477|NCT01643668|Secondary|Incidence of Hepatic Veno-occlusive Disease|The number of participants that experienced hepatic veno-occlusive disease (VOD). VOD is a condition in which some of the small veins in the liver are obstructed.|2 years||||Participants|||Count of Participants
2653478|NCT01643668|Secondary|Cumulative Incidence of Chronic GVHD at One Year|The percentage of participants who experienced chronic Graft Versus Host Disease (GVHD) by one year. GVHD is a condition that can occur following an allogenic stem cell transplantation when the donated bone marrow or peripheral stem cells view the recipients body as foreign and the donated cell/marrow attack the body. Chronic GVHD normally occurs after the first 100 days post transplantation. Chronic GVHD can adversely influence long term survival.|1 year||||percentage of participants||95% Confidence Interval|Number
2653479|NCT01643668|Secondary|Cumulative Incidence and Severity of Acute GVHD Within 100 Days Post Transplant|The percentage of participants who experienced grades 2-4 and grades 3-4 acute graft-versus-host disease (GVHD) by 100 days post transplantation. GVHD is a condition that can occur following an allogenic stem cell transplantation when the donated bone marrow or peripheral stem cells view the recipients body as foreign and the donated cell/marrow attack the body. Acute GVHD is generally observed within the first 100 days post transplant. Acute GVHD is associated with increased treatment related morbidity and mortality. Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening. The grade of the GVHD is determined by grading GHVD associated adverse events. Associated adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4 which uses the same mild, moderate, severe, life threatening grading system as the overall GHVD assessment.|100 days||||percentage of Participants||95% Confidence Interval|Number
2653480|NCT01643668|Secondary|Progression-Free and Overall Survival|The 1-year and 2-year progression-free and overall survival measured from the time of stem cell transplantation. Progression is the recurrence or increase in the number of cancer cells found in the body.|1 year, 2 years||||percentage of participants||95% Confidence Interval|Number
2653481|NCT01643668|Secondary|Cumulative Incidence of Non-relapse Mortality|The percentage of participants that experienced non-relapse mortality (NRM) at day 100 and 1 year after BuClo RIC SCT. Non-relapse mortality is any mortality that is not associated with or proceeded by disease progression of prior cancers.|100 days, 1 year||||percentage of participants who died||95% Confidence Interval|Number
2653482|NCT01643668|Primary|Donor Stem Cell Engraftment: Platelet Count|Platelet recovery was defined as having a platelet count of at least 20,000 platelets/uL of blood on 2 consecutive measurements without transfusional support prior to day +100 after BuClo RIC HSCT.|1, 2, 3, 4, 8, and 14 weeks post transplant|One participant experienced early death before engraftment. Outcome measure was assessed among the remaining 33 evaluable participants.|||Participants|||Count of Participants
2653483|NCT01643668|Primary|Assessment of Donor Stem Cell Engraftment: ANC Count|Patients are considered to have achieved donor cell engraftment if they have an absolute neutrophil count (ANC) of at least 500 cells/uL of blood for 3 consecutive measurements and at least 75% of hematopoietic elements are donor-derived as determined by chimerism assays from peripheral blood prior to day +40 after Busulfan/Clofarabine (BuClo) reduced intensity allogeneic stem cell transplantation|1, 2, 3, and 4 weeks after transplantation|One participant experienced early death before engraftment. Outcome measure was assessed among the remaining 33 evaluable participants.|||Participants|||Count of Participants
2653484|NCT01643616|Primary|Success Rate With Supplementation|"After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block.~success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1)~success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required (success rate without supplementation and additionally all supplemented blocks, outcome measure 3)~failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic divisionSucces rate with supplementation"|later than 30-60 minutes after injection of the local anesthetic||||participants|||Number
2653485|NCT01643616|Primary|Time Until Readiness for Surgery (Minutes)||within 60 minutes after injection of the local anesthetic||||minutes||95% Confidence Interval|Mean
2653486|NCT01643616|Primary|Success Rate Without Supplementation|"After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block.~success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1)~success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required (success rate without supplementation and additionally all supplemented blocks, outcome measure 3)~failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic division"|within 30-60 minutes after injection of the local anesthetic|In the NS group two investigators were necessary in order to realize the blinded study protocol. For personnel reasons this was not possible in every case and led to deviations from the randomization protocol for seven patients in each group. These patients were excluded from the analysis.|||participants|||Number
2653487|NCT01643525|Secondary|Nautilus NeuroWaveTM Recording in MRI Normal Population (no Cerebrovascular Disease Per MRI)||At study completion- approximately 8 months|||||||
2653488|NCT01643525|Secondary|Incidence of Device Related Adverse Events||At study completion- approximately 8 months|||||||
2653489|NCT01643525|Secondary|Determine the Location to Left, Right, Deep, and/or Back of the Cranium||At study completion- approximately 8 months|||||||
2653491|NCT01643473|Secondary|Change From Baseline in Self-reported Medication Adherence at 3 Months|Medication adherence will be assessed by self-report using the validated 8-item Morisky Medication Adherence Scale. Scores range from 0-8, with higher scores indicative of better medication adherence.|Baseline and 3 months||||score on a scale||Standard Error|Mean
2653492|NCT01643473|Secondary|Change From Baseline in HbA1c at 3 Months|Change in HbA1c from baseline to 3 months using a validated point-of-care device (Afinion AS100 Analyzer) at baseline and 3 months.|baseline and 3 months||||percentage of A1c||Standard Error|Mean
2653493|NCT01643473|Secondary|Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months|Change in mean systolic and diastolic blood pressure readings from baseline to 3 months. Systolic and diastolic blood pressure are measured in mmHg using a validated automated blood pressure monitor. The average of three readings was used as the blood pressure measurements for the baseline and 3 month study visit.|baseline and 3 months||||mmHg||Standard Error|Mean
2653494|NCT01643473|Primary|Feasibility of Retaining Study Participants Through the 3 Month Trial|Feasibility is assessed as the absolute number of patients that are retained in the study once they are consented and enrolled at baseline.|3 months|The number of participants that were retained in the study from baseline to 3 months.|||Participants|||Count of Participants
2653495|NCT01643213|Primary|Subject's Treatment Preference|Subject were asked if he/she prefers their current period SCS therapy over the SCS therapy he/she received during the SCS trial period prior to Baseline|30 minutes after activation of stimulation||||participants|||Number
2653496|NCT01643044|Primary|Alcohol Use|Alcohol use will be measured at the time of delivery of their infant by self-report and urine analysis. The number represents the number of participants who were abstinent (reported no alcohol use and had a negative toxicology urine screen) from alcohol for the past 90 days.|self-reported use during 90 days prior to delivery of their baby||||participants|||Number
2653497|NCT01642914|Primary|9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder|A 9/12 Week CSBM 3+1 Responder is a patient who is a CSBM 3+1 Weekly Responder for at least 9 out of the 12 weeks of the Treatment Period. A CSBM 3+1 Weekly Responder is a patient who had a CSBM Weekly Frequency Rate that was 3 or greater and increased by 1 or more from baseline.|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||participants|||Number
2653498|NCT01642914|Secondary|9/12 Week Mild Straining and Diarrhea-free Responder|"A patient was a 9/12 week mild straining and diarrhea-free responder if that patient met the weekly criterion for at least 9 weeks of the 12-week treatment period. A patient was considered to have met the weekly criterion in a given week if that patient had a nonmissing average straining score ≤ 2 (where a value of 1 represents no straining, an a value of 5 represents an extreme amount of straining), and the patient had no diarrhea adverse event (AE) reported for that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||participants|||Number
2653499|NCT01642914|Secondary|Change From Baseline in Severity of Straining at Week 12|"Severity of straining was measured using a 5-point ordinal scale, where of value of 1 is not at all and a value of 5 is an extreme amount.~A patient's straining score for baseline was derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's straining score at Week 12 was the average of the nonmissing straining scores from the SBMs reported by that patient during analysis Week 12.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 12|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||units on a scale||Standard Deviation|Mean
2653500|NCT01642914|Secondary|Change From Baseline in 12-week Severity of Straining|"Severity of straining was measured using a 5-point ordinal scale, where of value of 1 is not at all and a value of 5 is an extreme amount. A patient's straining score for baseline was derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's straining score for the treatment period was the average of the nonmissing straining scores from the SBMs reported by the patient during the 12-week treatment period.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||units on a scale||Standard Deviation|Mean
2653530|NCT01642602|Primary|Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants While Receiving Dexlansoprazole During the 4 Week Treatment Period|A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that started or worsened on or after Study Day 1 (defined as first dose day), and no more than 30 days after the last dose of study drug.|4 weeks|Safety analysis set: All participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2653501|NCT01642914|Secondary|Change From Baseline in Stool Consistency at Week 12|"Stool consistency was measured using the 7-point Bristol Stool Form Scale (BSFS):~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid]~A patient's BSFS score for the baseline period (14 days before randomization, up to the time of randomization) and at week 12, was the average of the nonmissing BSFS scores from the SBMs reported by the patient during the respective baseline period and during Week 12.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 12|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||units on a scale||Standard Deviation|Mean
2653502|NCT01642914|Secondary|Change From Baseline in 12-week Stool Consistency|"Stool consistency was measured using the 7-point Bristol Stool Form Scale (BSFS):~= separate hard lumps like nuts [difficult to pass]~= sausage shaped but lumpy~= like a sausage but with cracks on surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges [passed easily]~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces [entirely liquid]~A patient's BSFS score for the baseline period (14 days before randomization, up to the time of randomization) and for the 12-week treatment period, was the average of the nonmissing BSFS scores from the SBMs reported by the patient during the respective baseline and treatment periods.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||units on a scale||Standard Deviation|Mean
2653503|NCT01642914|Secondary|Time to Spontaneous Bowel Movement (SBM) After the First Dose of Investigational Product|"Time to first SBM after the first dose of investigation product was defined as the number of hours between the time of the first dose of investigational product to the occurrence of the first SBM. Patients who did not achieve an SBM were considered censored, with time to censoring defined as the number of hours elapsing from the time of the first dose of investigational product was taken to the end of the day of the last dose, at 12:00 AM (24:00 military time).~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||Hours||95% Confidence Interval|Median
2653504|NCT01642914|Secondary|SBM Within 24 Hours After the First Dose of Investigational Product|"The proportion of patients with a SBM within 24 hours of first taking investigational product in each linaclotide dose group was compared with the proportion in the placebo group using the Cochran-Mantel-Haenszel (CMH) test controlling for geographic region.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|24 hours from first dose of investigational product (Day 1)|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||participants|||Number
2653505|NCT01642914|Secondary|Change From Baseline in the Number of Days With a Spontaneous Bowel Movement (SBM)|"A patient's baseline number of days with a Spontaneous Bowel Movement (SBM) was calculated as the number of days with at least 1 Spontaneous Bowel Movement (SBM), derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's number of days with a SBM during the Treatment Period was calculated as the number of days with at least 1 Spontaneous Bowel Movement (SBM), divided by treatment duration (in days), and multiplied by 7.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||Days per week||Standard Deviation|Mean
2653506|NCT01642914|Secondary|Change From Baseline in SBM Frequency Rate at Week 12|"A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at week 12 was the SBM rate (SBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 12|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||SBMs per week||Standard Deviation|Mean
2653507|NCT01642914|Secondary|Change From Baseline in SBM Frequency Rate at Week 8|"A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at Week 8 was the SBM rate (SBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 8|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||SBMs per week||Standard Deviation|Mean
2653508|NCT01642914|Secondary|Change From Baseline in SBM Frequency Rate at Week 4|"A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at Week 4 was the SBM rate (SBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 4|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||SBMs per week||Standard Deviation|Mean
2653509|NCT01642914|Secondary|Change From Baseline in SBM Frequency Rate at Week 1|"A patient's baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's SBM frequency rate at week 1 was the SBM rate (SBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 1|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||SBMs per week||Standard Deviation|Mean
2653510|NCT01642914|Secondary|Change From Baseline in 12-Week SBM Frequency Rate|"A patient's Baseline SBM frequency rate is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's 12-week SBM frequency rate was the SBM rate (SBMs/week) calculated over the 12 weeks of the treatment period.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||SBMs per week||Standard Deviation|Mean
2653511|NCT01642914|Secondary|Change From Baseline in CSBM Frequency Rate at Week 12|"A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 12 was the CSBM rate (CSBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 12|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||CSBMs per week||Standard Deviation|Mean
2653512|NCT01642914|Secondary|Change From Baseline in CSBM Frequency Rate at Week 8|"A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 8 was the CSBM rate (CSBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 8|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||CSBMs per week||Standard Deviation|Mean
2653531|NCT01642589|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine|"Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.~Grade 3 injection site reactions: Pain - Significant, prevents daily activity; Redness and Swelling - > 100 mm. Grade 3 Systemic reactions: Fever - ≥ 39.0°C; Headache, Malaise, and Myalgia - Significant, prevents daily activity."|Day 0 up to Day 28 post-vaccination|Solicited injection site and systemic events were assessed in all randomized and vaccinated study participants, Safety Analysis Set|||Participants|||Number
2653513|NCT01642914|Secondary|Change From Baseline in CSBM Frequency Rate at Week 4.|"A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 4 was the CSBM rate (CSBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 4|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||CSBMs per week||Standard Deviation|Mean
2653514|NCT01642914|Secondary|Change From Baseline in CSBM Frequency Rate at Week 1.|"A patient's CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's CSBM frequency rate at week 1 was the CSBM rate (CSBMs/week) calculated over that week.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and Week 1|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||CSBMs per week||Standard Deviation|Mean
2653515|NCT01642914|Secondary|Change From Baseline in 12-week CSBM Frequency Rate|"A patient's 12-week CSBM frequency rate from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). A patient's 12-week CSBM frequency rate was the CSBM rate (CSBMs/week) calculated over the 12 weeks of the treatment period.~Only the Placebo versus Linaclotide 145 micrograms arm comparison is a secondary measure type for this outcome measure. The additional data for the Linaclotide 290 micrograms arm (a pre-specified additional outcome measure) is presented here for ease of comparison."|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||CSBMs per week||Standard Deviation|Mean
2653516|NCT01642914|Secondary|6/12 Week Abdominal Bloating 30% Responder|A patient was a 6/12 week abdominal bloating 30% responder if, for at least 6 weeks of the 12-week treatment period, that patient's improvement from baseline in the weekly abdominal bloating score was ≥ 30% from baseline.|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||participants|||Number
2653517|NCT01642914|Secondary|Percent Change From Baseline in Abdominal Bloating at Week 12|Abdominal bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). The percent change from baseline at Week 12 in Abdominal Bloating score is the percentage difference between the average nonmissing daily patient assessments of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during Week 12.|Baseline and Week 12|Reported outcome data is based on the 483 patient Intent-to-Treat Population. The distribution of each of the linaclotide groups was compared, in a pair-wise manner, to the placebo group using the two-sample Kolmogorov–Smirnov test.|||percentage change in abdominal bloating||Standard Deviation|Mean
2653518|NCT01642914|Secondary|Percent Change From Baseline in 12-week Abdominal Bloating|Abdominal Bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization, up to the time of randomization (Visit 3, Day 1). The percent change from baseline in 12-Week Abdominal Bloating score is the percentage difference between the average nonmissing daily patient assessments score of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during the 12 week Treatment Period.|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||percentage change of NRS score||Standard Deviation|Mean
2653532|NCT01642589|Secondary|Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination|Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and 28 days post-vaccination|Geometric mean titers for the anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set|||Titers||95% Confidence Interval|Geometric Mean
2653629|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||30min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||cm/s||Standard Deviation|Mean
2653519|NCT01642914|Secondary|Change From Baseline in 12-Week Abdominal Bloating|Abdominal Bloating was measured daily using an 11-point Numerical Rating Scale (NRS) where a value of 0 represents no abdominal bloating and a value of 10 represents very severe abdominal bloating. The abdominal bloating score from Baseline is derived from the Interactive Voice Response System (IVRS) daily diary data collected in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization (Visit 3, Day 1). The change from baseline in 12-Week Abdominal Bloating score is the difference between the average nonmissing daily patient assessments of abdominal bloating scores during the 14 day Baseline period, and the average of the nonmissing daily patient assessments of abdominal bloating scores reported during the 12 week Treatment Period.|Baseline and 12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||units on a scale||Standard Deviation|Mean
2653520|NCT01642914|Secondary|9/12 Week Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder|A 9/12 Week CSBM 3+1 Responder is a patient who is a CSBM 3+1 Weekly Responder for at least 9 out of the 12 weeks of the Treatment Period. A CSBM 3+1 Weekly Responder is a patient who had a CSBM Weekly Frequency Rate that was 3 or greater and increased by 1 or more from baseline.|12-week treatment period|487 patients were randomized to treatment (Randomized Population). The Safety population consists of 486 randomized patients who received at least one dose of study drug. The Intent to Treat (ITT) population consists of 483 patients in the Safety population with valid post-baseline efficacy data. Reported outcome data is based on the ITT Population|||participants|||Number
2653521|NCT01642732|Secondary|Difference in Serologic Everolimus and Prostate Biomarker Levels Before and After Treatment With Everolimus|Analysis of pairs of markers will be explored looking for large positive or negative correlations to indicate marker areas for further research.|Prior to treatment and at 14 days|One patient was enrolled and withdrew from the study prior to treatment. The objective was not analyzed.||||||
2653522|NCT01642732|Primary|Number of Patients With Adverse Events on Oral Everolimus in Combination With Hormonal Ablation and External Beam Radiation||64 months after beginning everolimus|One patient was enrolled and withdrew from the study prior to treatment. The primary objective was not analyzed.||||||
2653523|NCT01642615|Secondary|Percent of Days With Neither Daytime Nor Nighttime Heartburn Over Weeks 8 to 24|The percent of days with neither daytime nor nighttime heartburn over Weeks 8 to 24 as assessed by electronic daily diary among the participants who were healed at Week 8. The percent of days with neither daytime or nighttime heartburn = (total number of days that are heartburn free)/(total number of days for which either a daytime or nighttime result is marked) x 100%.|Weeks 8 to 24|Participants from the Full Analysis Set, all participants with healed EE at Week 8 who were randomized and received at least one dose of open-label study drug in Weeks 8 to 24.|||percent of days||Standard Deviation|Mean
2653524|NCT01642615|Secondary|Percent of Days With Neither Daytime Nor Nighttime Heartburn Over the First 8 Weeks of Treatment|Percent of days with neither daytime nor nighttime heartburn over the first 8 weeks of treatment as assessed by electronic daily diary. The percent of days with neither daytime or nighttime heartburn = (total number of days that are heartburn free)/(total number of days for which either a daytime or nighttime result is marked) x 100%.|8 weeks|Participants from the Full Analysis Set, all enrolled participants who received at least one dose of open-label study drug in the first 8 weeks, with data available for analysis.|||percent of days||Standard Deviation|Mean
2653525|NCT01642615|Secondary|Percentage of Participants Who Maintain Healing of EE From Week 8 to Week 24|Percentage of participants who maintain healing of EE from Week 8 to Week 24 among the patients who were healed at Week 8 as assessed by endoscopy.|From Week 8 to Week 24|Participants from the Full Analysis Set, all participants with healed EE at Week 8 who were randomized and received at least one dose of open-label study drug in Weeks 8 to 24.|||percentage of participants||95% Confidence Interval|Number
2653526|NCT01642615|Secondary|Percentage of Participants With Healing of Erosive Esophagitis (EE) by Week 8|Healing of EE was assessed by endoscopy.|8 weeks|Participants from the Full Analysis Set, all enrolled participants who received at least one dose of open-label study drug in the first 8 weeks, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2653527|NCT01642615|Primary|Percent of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 16-week Maintenance Treatment Period|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose.|From Week 8 to Week 24|Safety Analysis Set included all participants with healed EE at Week 8 who were randomized and received at least one dose of open-label study drug in Weeks 8 to 24.|||percentage of participants|||Number
2653528|NCT01642615|Primary|Percentage of Participants Who Experience Each Treatment Emergent Adverse Event Experienced by ≥5% of Participants During the 8-week Healing Treatment Period|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens on or after Study Day 1, and no more than 30 days after the last dose.|8 weeks|Safety analysis set includes all enrolled participants who received at least one dose of open-label study drug in the first 8 weeks.|||percentage of participants|||Number
2653529|NCT01642602|Secondary|The Percentage of Days With Neither Daytime Nor Nighttime Heartburn Over the 4 Weeks of Treatment|Participants documented the presence or absence and the degree to which daytime and nighttime heartburn symptoms hurt daily in an electronic daily diary.|4 weeks|Full analysis set: All participants who received at least 1 dose of study drug and had post-baseline data (and baseline data if applicable) for the efficacy variable.|||Percentage of days||Full Range|Median
2653533|NCT01642589|Secondary|Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination.|Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:128 dilution.|Day 0 (pre-vaccination) and 28 days post-vaccination|Functional antibody activity for anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set|||Percentage of participants|||Number
2653534|NCT01642589|Secondary|Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination|Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR) at ≥ 1:8 dilution.|Day 0 (pre-vaccination) and 28 days post-vaccination|Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were determined in the Full Analysis Set|||Percentage of participants|||Number
2653535|NCT01642589|Primary|Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine|"Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR).~Seroconversion was defined as post-vaccination antibody titers of ≥ 4-fold increase from pre-vaccination level."|28 Days post-vaccination|Functional antibody activity for anti meningococcal antibody to serogroups A, C, Y, and W 135 were determined in the Full Analysis Set|||Percentage of participants|||Number
2653536|NCT01642485|Secondary|The QTcF Profile of Oral Moxifloxacin (400 mg) in Healthy Japanese Versus Caucasian Subjects||0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose||||ms||95% Confidence Interval|Mean
2653537|NCT01642485|Secondary|Insulin, Glucose and C-Peptide Effects on the QT/QTc Interval|The effect on QTc was investigated using linear mixed effect models with placebo corrected QTcF (change from average baseline) as a dependent variable and insulin, glucose and C-peptide (placebo corrected) as covariates for the data obtained under the euglycaemic clamp as well as for all data obtained under the clamp and the two types of breakfast.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose||||msec||95% Confidence Interval|Median
2653538|NCT01642485|Secondary|Moxifloxacin 400 mg (Single Dose) Compared to Placebo on the Mean QT/QTc Interval.|"Moxifloxacin 400mg Fasted group is reporting the maximum change in QT/QTc interval from placebo treatment."|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose||||ms||90% Confidence Interval|Mean
2653539|NCT01642485|Secondary|The Food Effects (Calorie Reduced FDA Breakfast and Carbohydrate Rich Continental Style) on QTcF|"Scott et al (2002) demonstrated an increase in the heart rate of 10bpm in some healthy subjects following ingestion of a carbohydrate meal. There was significant correlation between the resultant hyperinsulinaemia and an increase in skeletal muscle blood flow, and sympathetic activity, with a reduction in vascular resistance.~If postprandial insulinaemia is a significant influence on the QT interval, then carbohydrate rich meals would be expected to show greater effect. Therefore, to explore this on two separate days of the study subjects will be given one of two different types of breakfast:~A high carbohydrate content breakfast, (>70% carbohydrate)~A reduced calorie FDA standard breakfast, (58% fat, low carbohydrate content) to determine effect on QT interval."|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose||||ms||90% Confidence Interval|Mean
2653540|NCT01642485|Primary|The Effect of Food (Fasted and Fed State) on the Degree of QT Prolongation Caused by Moxifloxacin|The primary baseline corrections were calculated using averaged QTc baseline values (the mean of all median readings recorded for each time-point on the baseline Day -1). This single value (QTcbaselineAV) was used to calculate ΔQTc for each study period.|0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose|Since the baseline was used as a covariate in the analysis, using the standard deviation of the change from baseline, in the simple sample size formula is justified. Assuming a standard deviation of 7 msec for the single differences, sample sizes for the sum can therefore work with a standard deviation of 6.5 msec.|||ms||90% Confidence Interval|Mean
2653541|NCT01642407|Other Pre-specified|Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at Week 16|Tricuspid annular plane systolic excursion is a parameter depicting global right ventricular function. Change from baseline in TAPSE (in cm) was reported in this outcome measure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||cm||Standard Deviation|Mean
2653542|NCT01642407|Other Pre-specified|Number of Participants With Pericardial Effusion|Pericardial effusion is the presence of an abnormal amount of fluid in the pericardial cavity, as determined by echocardiography.|Baseline up to Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2653543|NCT01642407|Other Pre-specified|Change From Baseline in Pulmonary Regurgitation - Pressure Gradient (PR-PG) End-Diastole at Week 16|Pulmonary regurgitation (PR) or insufficiency is a valvular heart disease characterized by an incomplete closure of the pulmonary valve leading to a diastolic reflux into the right ventricle. Change from baseline in PR-PG end-diastole (in mmHg) was reported in this outcome measure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mmHg||Standard Deviation|Mean
2653544|NCT01642407|Other Pre-specified|Change From Baseline in Tricuspid Regurgitation - Pressure Gradient (TR-PG) Peak at Week 16|Tricuspid regurgitation (insufficiency) is the failure of the tricuspid valve to close properly during systole, leading to the leaking of blood from the right ventricle into the right atrium. Change from baseline in TR-PG peak (in mmHg) was reported in this outcome measure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mmHg||Standard Deviation|Mean
2653559|NCT01642407|Secondary|Change From Baseline in Cardiac Index (CI) at Week 16|Cardiac index is a hemodynamic parameter that relates the cardiac output from left ventricle in one minute to BSA, thus relating heart performance to the size of the individual. CI was calculated as cardiac output in systemic circulation divided by BSA.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||liter per minute per meter square||Standard Deviation|Mean
2653545|NCT01642407|Other Pre-specified|Change From Baseline in Tricuspid Valve Annulus Size at Week 16|The tricuspid valve lies between the right atrium and the right ventricle and is placed in a more apical position than the mitral valve. The annulus separates the right atrium from the right ventricle. Change from baseline in tricuspid valve annulus size (in cm) was reported in this outcome measure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||cm||Standard Deviation|Mean
2653546|NCT01642407|Other Pre-specified|Change From Baseline in Right Ventricular Size at Week 16||Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||centimeter (cm)||Standard Deviation|Mean
2653547|NCT01642407|Other Pre-specified|Change From Baseline in Right Ventricular Tei Index at Week 16|The right ventricular Tei Index is an index of myocardial performance. It is defined as the sum of isovolumic contraction time and isovolumic relaxation time divided by the ejection time.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||ratio||Standard Deviation|Mean
2653548|NCT01642407|Other Pre-specified|Change From Baseline in Ratio of Acceleration Time to Ejection Time (AcT/ET) at Week 16|Acceleration time and ejection time are quantitative Doppler parameters and ratio of acceleration time to ejection time is a useful tool to evaluate the severity of aortic stenosis.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||ratio||Standard Deviation|Mean
2653549|NCT01642407|Other Pre-specified|Apparent Volume of Distribution (Vz/F) of Sildenafil|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Pre-dose (0 hour) on Week 4, 8, 16 and 1, 2, 4, 8 hours post-dose on Week 16|PK parameter analysis set included all participants who have at least 1 of PK parameters of interest. Here, Overall Number of participants analyzed signifies those participants who were evaluable for this measure.|||liter||Full Range|Median
2653550|NCT01642407|Other Pre-specified|Apparent Oral Clearance (CL/F) of Sildenafil|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Pre-dose (0 hour) on Week 4, 8, 16 and 1, 2, 4, 8 hours post-dose on Week 16|PK parameter analysis set included all participants who have at least 1 of PK parameters of interest.|||liter per hour||Geometric Coefficient of Variation|Geometric Mean
2653551|NCT01642407|Other Pre-specified|Terminal Half Life (t1/2) of Sildenafil and UK-103,320|Terminal half-life is the time measured for the plasma concentration to decrease by one half of its original concentration. UK-103,320 was a main metabolite of sildenafil and was produced by cytochrome P450 3A4.|Pre-dose (0 hour) on Week 4, 8, 16 and 1, 2, 4, 8 hours post-dose on Week 16|PK parameter analysis set included all participants who have at least 1 of PK parameters of interest. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||hour||Full Range|Median
2653552|NCT01642407|Other Pre-specified|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Sildenafil and UK-103,320|UK-103,320 was the main metabolite of Sildenafil and was produced by cytochrome P450 3A4.|Pre-dose (0 hour) on Week 4, 8, 16 and 1, 2, 4, 8 hours post-dose on Week 16|PK parameter analysis set included all participants who have at least 1 of PK parameters of interest.|||hour||Full Range|Median
2653553|NCT01642407|Other Pre-specified|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Sildenafil and UK-103,320|UK-103,320 was the main metabolite of Sildenafil and was produced by cytochrome P450 3A4.|Pre-dose (0 hour) on Week 4, 8, 16 and 1, 2, 4, 8 hours post-dose on Week 16|PK parameter analysis set included all participants who have at least 1 of PK parameters of interest.|||nanogram*hour per millimeter||Geometric Coefficient of Variation|Geometric Mean
2653554|NCT01642407|Other Pre-specified|Maximum Observed Plasma Concentration (Cmax) of Sildenafil and UK-103,320|UK-103,320 was the main metabolite of Sildenafil and was produced by cytochrome P450 3A4.|Pre-dose (0 hour) on Week 4, 8, 16 and 1, 2, 4, 8 hours post-dose on Week 16|Pharmacokinetic (PK) parameter analysis set included all participants who have at least 1 of PK parameters of interest.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2653555|NCT01642407|Secondary|Change From Baseline in Arterial Oxygen Saturation (SaO2) at Week 16|SaO2 is the percentage of arterial oxygen (amount of oxygen bound to hemoglobin in arterial blood). Change from baseline in percentage of arterial oxygen was reported in this outcome measure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||percentage of arterial oxygen||Standard Deviation|Mean
2653556|NCT01642407|Secondary|Change From Baseline in Mixed Venous Oxygen Saturation (SvO2) at Week 16|SvO2 is the percentage of mixed venous oxygen (amount of oxygen bound to hemoglobin in venous blood). Change from baseline in percentage of mixed venous oxygen was reported in this outcome measure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||percentage of mixed venous oxygen||Standard Deviation|Mean
2653557|NCT01642407|Secondary|Change From Baseline in Systemic Vascular Resistance Index (SVRI) at Week 16|SVRI equals systemic vascular resistance (SVR) times BSA. SVR is the resistance to blood flow through the systemic circulation and it was measured in Wood units. Wood unit =80 dyne*seconds per centimetre^5 (dyne*sec/cm^5).|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||Wood units*meter^2||Standard Deviation|Mean
2653558|NCT01642407|Secondary|Change From Baseline in Systemic Vascular Resistance (SVR) at Week 16|The resistance to blood flow through the systemic circulation is known as SVR. This can be used in measuring blood pressure, blood flow and cardiac function and measured in terms of Wood units. Wood unit =80 dyne*seconds per centimetre^5 (dyne*sec/cm^5).|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||Wood units||Standard Deviation|Mean
2653560|NCT01642407|Secondary|Change From Baseline in Cardiac Output (CO) at Week 16|Cardiac output is simply the amount of blood pumped by the heart per minute.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||liter per minute||Standard Deviation|Mean
2653561|NCT01642407|Secondary|Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Week 16|PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mmHg||Standard Deviation|Mean
2653562|NCT01642407|Secondary|Change From Baseline in Right Atrial Pressure (RAP) at Week 16|RAP is the blood pressure in the right atrium of the heart. It reflects the amount of blood returning to the heart and the ability of the heart to pump the blood into the arterial system. RAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mmHg||Standard Deviation|Mean
2653563|NCT01642407|Secondary|Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 16|The resistance to blood flow through the pulmonary circulation is known as PVR. It is largely influenced by the caliber of the pulmonary arteries and capillaries and was measured in terms of Wood units. Wood unit =80 dyne*seconds per centimetre^5 (dyne*sec/cm^5).|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||Wood units||Standard Deviation|Mean
2653564|NCT01642407|Secondary|Change From Baseline in Systemic Artery Systolic and Diastolic Pressure at Week 16||Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mmHg||Standard Deviation|Mean
2653565|NCT01642407|Secondary|Change From Baseline in Pulmonary Artery Systolic and Diastolic Pressure at Week 16||Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||mmHg||Standard Deviation|Mean
2653566|NCT01642407|Secondary|Number of Participants With Ocular Examination Abnormalities|Ocular examination measures included external examination of the eye, funduscopy, assessments of visual acuity, and color vision. Ocular examination findings were considered abnormal based on investigator's decision.|Screening up to end of treatment (maximum duration of treatment: 119.6 weeks)|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2653567|NCT01642407|Secondary|Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities|Criteria for clinically significant abnormality in ECG parameters: Maximum corrected QT interval (QTc) from 450 millisecond (msec) to less than (<) 480 msec, Maximum QTcB interval (Bazett's Correction) from 450 msec to <480 msec, Maximum QTcF interval (Fredericia's Correction) from 450 msec to <480 msec, maximum QTc interval increase from baseline of 30 msec to <60 msec and >=60 msec.|Screening, Week 16, Week 52 and End of treatment (maximum duration of treatment: 119.6 weeks)|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||Participants|||Count of Participants
2653568|NCT01642407|Secondary|Number of Participants With Laboratory Abnormalities|Laboratory abnormality criteria: Hematology (hemoglobin, hematocrit, red blood cell count [less than {<}]0.8*lower limit of normal [LLN]; platelets <0.5*LLN, greater than [>]1.75*upper limit of normal [ULN], white blood cells <0.6*LLN, >1.5*ULN; lymphocytes, neutrophils <0.8*LLN, >1.2*ULN, eosinophils, basophils, monocytes >1.2*ULN); liver function (total and direct bilirubin >1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN, total protein, albumin <0.8*LLN, >1.2*ULN); renal (creatinine, blood urea nitrogen >1.3*ULN); electrolytes (sodium <0.95*LLN, >1.05*ULN, potassium, chloride <0.9*LLN, >1.1*ULN; other (glucose <0.6*LLN or >1.5*ULN ); urinalysis (dipstick) urine glucose, urine protein, urine blood/Hemoglobin, [greater than or equal to {>=}1].|Baseline up-to End of treatment (maximum duration of treatment: 119.6 weeks)|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2653569|NCT01642407|Secondary|Change From Baseline in Heart Rate at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, 100, 112 and 124|Only those categories in which at least 1 participant had data were reported.|Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, 100, 112 and 124|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||beats per minute (bpm)||Standard Deviation|Mean
2653570|NCT01642407|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, 100, 112 and 124|BP measurement is recorded as supine and sitting systolic and diastolic systemic blood pressure: 1) Systolic blood pressure when heart is contracting and it is the maximum arterial pressure during contraction of left ventricle. 2) Diastolic BP when heart is relaxing and it is the minimum arterial pressure during relaxation and dilation of ventricles. Only those categories in which at least 1 participant had data were reported.|Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, 100, 112 and 124|Safety analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||mmHg||Standard Deviation|Mean
2653588|NCT01642251|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as time from randomization to death from any cause. Median OS was estimated using the Kaplan-Meier method.|Assessed every 3 months for patients < 2 years from registration and every 6 months if patient is 2- 3 years from registration until the date of death. No specific requirements if patient is > 3 years from registration|Eligible and treated patients|||months||95% Confidence Interval|Median
2653630|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||after surgery at extubation (average surgery duration: craniotomy group 214min, abdominal group 207min)|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||cm/s||Standard Deviation|Mean
2653571|NCT01642407|Secondary|Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious AEs.|Baseline upto 28 days after last dose of study drug (maximum duration of treatment: 119.6 weeks)|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2653572|NCT01642407|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious AEs.|Baseline upto 28 days after last dose of study drug (maximum duration of treatment: 119.6 weeks)|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2653573|NCT01642407|Secondary|Change From Baseline in N-terminal Pro Brain Natriuretic Peptide (NT Pro-BNP) at Week 52 and End of Treatment (EOT)|NT pro-BNP is a cardiac marker, having the prognostic value for participants with heart failure or left ventricular dysfunction. Higher level of the marker was indicative of heart damage.|Baseline, Week 52 and End of treatment (maximum duration of treatment: 119.6 weeks)|EEfficacy analysis set included all participants who received at least 1 dose of study drug.Here 'Overall number of participants analyzed' specifies number of participants who completed Part 1 of the study and continued treatment with Sildenafil in Part 2 of the study.|||picograms per milliliter||Standard Deviation|Mean
2653574|NCT01642407|Secondary|Change From Baseline in Brain Natriuretic Peptide (BNP) at Week 52 and End of Treatment (EOT)|BNP is produced by ventricular cardiomyocytes. It causes reduction in preload and blood pressure by vasodilatation.|Baseline, Week 52 and End of treatment (maximum duration of treatment: 119.6 weeks)|Efficacy analysis set included all participants who received at least 1 dose of study drug.Here 'Overall number of participants analyzed' specifies number of participants who completed Part 1 of the study and continued treatment with Sildenafil in Part 2 of the study.|||picograms per milliliter||Standard Deviation|Mean
2653575|NCT01642407|Secondary|Change From Baseline in World Health Organization (WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Weeks 28, 40, 52, 64, 76, 88, 100, 112 and 124|"WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). The change from baseline in WHO functional class was classified into Improved, No change and Worsened. Improvement = reduction in functional class, worsened = increase in functional class and no change = no change in functional class. Change from baseline in number of participants in each functional class were reported."|Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, 100, 112 and 124|Efficacy analysis set was used in this analysis. Here, 'Overall number of participants analyzed' specifies number of participants who completed Part 1 of the study and continued treatment with Sildenafil in Part 2 of the study and ‘Number analyzed’ = Participants evaluable for this outcome measure for specified categories.|||Participants|||Count of Participants
2653576|NCT01642407|Primary|Change From Baseline in N-terminal Pro Brain Natriuretic Peptide (NT Pro-BNP) at Week 16|NT pro-BNP is a cardiac marker, having the prognostic value for participants with heart failure or left ventricular dysfunction. Higher level of the marker was indicative of heart damage.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||picogram per milliliter||Standard Deviation|Mean
2653577|NCT01642407|Primary|Change From Baseline in Brain Natriuretic Peptide (BNP) at Week 16|BNP is produced by ventricular cardiomyocytes. It causes reduction in preload and blood pressure by vasodilatation.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||picogram per milliliter||Standard Deviation|Mean
2653578|NCT01642407|Primary|Change From Baseline in World Health Organization (WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Week 16|"WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). The change from baseline in WHO functional class was classified into Improved, No change and Worsened. Improvement = reduction in functional class, worsened = increase in functional class and no change = no change in functional class. Change from baseline in number of participants in each functional class were reported."|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, Overall Number of participants analyzed signifies those participants who were evaluable for this measure.|||participants|||Number
2653608|NCT01642212|Secondary|Distribution of Responses For The Patient Global Impression of Change (PGIC) Survey at The Final Treatment Evaluation|Participants evaluated the change in their dysphasia (food passing slowly/difficulty swallowing) since the start of the study (screening) by choosing 1 of 7 responses on the PGIC survey: much worse (-3), worse (-2), a little worse (-1), no change (0), a little better (1), better (2), or much better (3). The values reported are the percent of participants who chose that response.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
2653579|NCT01642407|Primary|Change From Baseline in World Health Organization (WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Week 8|"WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). The change from baseline in WHO functional class was classified into Improved, No change and Worsened. Improvement = reduction in functional class, worsened = increase in functional class and no change = no change in functional class. Change from baseline in number of participants in each functional class were reported."|Baseline, Week 8|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here,'N' (Overall number of participants analyzed) signifies those participants who were evaluable for this measure.|||participants|||Number
2653580|NCT01642407|Primary|Change From Baseline in World Health Organization (WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Week 4|"WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). The change from baseline in WHO functional class was classified into Improved, No change and Worsened. Improvement = reduction in functional class, worsened = increase in functional class and no change = no change in functional class. Change from baseline in number of participants in each functional class were reported."|Baseline, Week 4|Efficacy analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2653581|NCT01642407|Primary|Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Week 16|It was a hemodynamic parameter and measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2653582|NCT01642407|Primary|Change From Baseline in Pulmonary Vascular Resistance Index (PVRI) at Week 16|PVRI equals pulmonary vascular resistance (PVR) times body surface area (BSA) (PVRI = PVR*BSA). PVR is the resistance to blood flow through the pulmonary circulation and it was measured in Wood units. Wood unit =80 dyne*seconds per centimetre^5 (dyne*sec/cm^5).|Baseline, Week 16|Efficacy analysis set included all participants who received at least 1 dose of study drug. Here, ‘Number analyzed’ = Participants evaluable for this outcome measure at specified time points.”|||wood units*meter^2||Standard Deviation|Mean
2653583|NCT01642277|Secondary|Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire|"The PFDI comprises 46 items on a 4-point symptom severity scale ranging from 1 = Not at all to 4 = Quite a bit. From these items, 13 separate sub-scales are reported: (1) Obstructive discomfort, (2) Irritation, (3) Stress resulting from urinal distress, (4) A general sub-scale for pelvic organ prolapse distress, (5) An anterior sub-scale for pelvic organ prolapse distress, (6) A posterior sub-scale for pelvic organ prolapse distress, (7) An obstructive sub-scale for colorectal anal distress, (8) Incontinence, (9) Pain, and (10) A rectal prolapse sub-scale for colorectal anal distress. For each of these sub-scales, scores from from 0 to 100 (where higher scores indicate greater symptom severity). There are three additional sub-scales: (11) The urinary distress inventory, (12) The pelvic organ distress inventory, and (13) The colorectal distress inventory. Each of these ranges from 0 to 400 (with higher scores indicating greater symptom severity)."|12 weeks|Participants who received solifenacin were asked to complete the PFDI questionnaire at 12 weeks in order to assess certain bowel, bladder, and pelvic symptoms.|||units on a scale||Inter-Quartile Range|Median
2653584|NCT01642277|Secondary|Assessment of Overactive Bladder Questionnaire (OABQ)|The Overactive Bladder Questionnaire (OAB-q) was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related quality of life (HRQL). The instrument comprises 33 items. Response options for the symptom frequency and HRQL items are presented as 6-point Likert scales ranging from 'none of the time' to 'all of the time' for symptom frequency (and 'not at all' to 'a very great deal' for symptom bother). From these 33 items, six sub-scales are assessed separately: (1) OAB symptom severity, (2) Coping with OAB symptoms, (3) Concern for OAB symptoms, (4) Sleep as a function of OAB symptoms, (5) Social functioning as a consequence of OAB symptoms, and (6) Health related quality of life (HRQL) as a function of OAB symptoms. Each sub-scale score ranges from 0 to 100 (where higher scores indicate more severe OAB symptoms and lower scores indicate minimal symptom severity).|End of study (Week 12)|Participants who received solifenacin were asked to complete the OABQ at 12 weeks in order to assess overactive bladder symptoms.|||units on a scale||Inter-Quartile Range|Median
2653585|NCT01642277|Primary|Bacterial Genomic Sequencing|Participants were classified into Low Biomass, Lactobacillus, Gardnerella, Diverse, and Other urotypes based on the bacterial DNA at baseline.|12 weeks|This was a completer analysis comprising participants who completed 12 weeks of treatment (n = 50).|||participants|||Number
2653586|NCT01642251|Other Pre-specified|Neurotoxicity Total Score Change Between Baseline and 3 Months After Treatment Start|Neurotoxicity total score was measured by the 11 items in the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire. Each item was scored from 0-4. The severity of neurotoxicity was measured by the total score of the 11 items, ranged from 0 to 44. Lower values of the FACT/GOG-Ntx neurotoxicity total score indicate higher neurotoxicity.|assessed at baseline and 3 months after treatment initiation|eligible and treated patients who had neurotoxicity data at both baseline and 3 months assessments|||units on a scale||Standard Deviation|Mean
2653587|NCT01642251|Secondary|Overall Response Rate (ORR)|Tumor response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Complete response (CR) was defined as disappearance of all target lesions. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Overall response rate= (CR+PR)/all eligible and treated patients|assessed every 6 weeks while on study, then every 3 months for patients < 2 years from registration and every 6 months if patient is 2- 3 years from registration.|Eligible and treated patients|||percentage of patients||95% Confidence Interval|Number
2653626|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery||120min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||cm/s||Standard Deviation|Mean
2653589|NCT01642251|Primary|Progression Free Survival (Phase II)|Profession free survival (PFS) is defined as time from randomization to date of disease progression or death from any cause, whichever occurred first. Patients who had not experienced an event of interest by the time of analysis were censored at the date they were last known to be alive and progression-free. Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria, and progression was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Median PFS was estimated using the Kaplan-Meier method.|Assessed every 3 months for patients < 2 years from registration and every 6 months if patient is 2- 3 years from registration until the date of first documented progression or death. No specific requirements if patient is > 3 years from registration|Eligible and treated patients|||months||80% Confidence Interval|Median
2653590|NCT01642251|Primary|Recommended Phase II Dose (Phase I)|dose of veliparib which was deemed to be the recommended phase II dose to be administered in the combination with CE for the phase II clinical trial|assessed for a maximum of cycle 1|all eligible and treated patients|||mg|||Number
2653591|NCT01642238|Secondary|Blood Thrombogenicity|Coagulation times, assessed using the ROTEM thromboelastometry|24-hours post-treatment||||seconds||95% Confidence Interval|Mean
2653592|NCT01642238|Secondary|Blood Thrombogenicity|Coagulation times, assessed using the ROTEM thromboelastometry|1 hr post-treatment||||seconds||95% Confidence Interval|Mean
2653593|NCT01642238|Secondary|Blood Thrombogenicity|Coagulation times, assessed using the ROTEM thromboelastometry|Pre-treatment baseline||||seconds||95% Confidence Interval|Mean
2653594|NCT01642238|Secondary|Platelet Reactivity|Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition|24-hours post-treatment||||percent inhibition||95% Confidence Interval|Mean
2653595|NCT01642238|Secondary|Platelet Reactivity|Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition|1 hr post-treatment||||percent inhibition||95% Confidence Interval|Mean
2653596|NCT01642238|Secondary|Platelet Reactivity|Platelet reactivity measured by VerifyNowP2Y12 assay measuring percent inhibition|Pre-treatment baseline||||percent inhibition||95% Confidence Interval|Number
2653597|NCT01642238|Primary|Platelet-thrombus Formation in an ex Vivo Model of Thrombosis|Change in thrombus size at 24 hours as compared to Pre-treatment baseline, where a positive change represents a decrease in thrombus size.|Pre-treatment baseline and 24 hrs post treatment||||percent change||95% Confidence Interval|Mean
2653598|NCT01642238|Primary|Platelet-thrombus Formation in an ex Vivo Model of Thrombosis|Change in thrombus size at 1 hour as compared to Pre-treatment baseline, where a positive change represents a decrease in thrombus size.|Pre-treatment baseline and 1 hour||||percent change||95% Confidence Interval|Mean
2653599|NCT01642212|Secondary|Change From Baseline in The Scores of DSQ Question 4 During The Treatment Period|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). Question 4 is rated as None, I had no pain (score=0), mild pain (score=1), moderate pain (score=2), severe pain (score=3), or very severe pain (score=4); 4 is the worst pain. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.|Baseline, Weeks 8, 12, and 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||scores on a scale||Standard Error|Least Squares Mean
2653600|NCT01642212|Secondary|Change From Baseline in The Scores of DSQ Question 1 During The Treatment Period|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). Question 1 is rated as Yes (score=0) or No (score=1); higher values indicate a worse outcome. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.|Baseline, Weeks 8, 12, and 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||scores on a scale||Standard Error|Least Squares Mean
2653601|NCT01642212|Secondary|Percent of Days That Participants Reported That They Avoided Solid Food During The Baseline And Treatment Periods|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). Values were calculated for all the days that Question 1 was answered from 14 days prior to baseline visit up to the final treatment period evaluation.|From 14 days prior to the baseline visit to the final treatment period evaluation|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percentage of days||Inter-Quartile Range|Mean
2653602|NCT01642212|Secondary|Percent of Participants Who Were Symptom Responders on The DSQ+Pain Scale at The Final Treatment Period Evaluation|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Question 1 (did you eat solid food) and Question 2 (did food pass slowly or get stuck). If the answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Question 3 (did you have to do anything to make the food go down or get relief) and Question 4 (extent to which the participant experienced pain while swallowing).The DSQ+pain response was defined as a >/= 30% and >/= 50% reduction from baseline in the combined score from Questions 2, 3, and 4. The 2-week DSQ+pain score was calculated by adding points from Questions 2, 3, and 4 and then taking the average of the available scores over each 2-week interval.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
2653603|NCT01642212|Secondary|Percent of Participants With New Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation|This outcome assessed the symptoms of participants who were symptom-free at baseline. The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report any symptom at baseline, but changed to report at least 1 symptom at the final treatment evaluation.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
2653604|NCT01642212|Secondary|Percent of Participants Without Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation|This outcome assessed the symptoms of participants who were symptom-free at baseline. The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: No change - participant did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report any symptom at baseline, but changed to report at least 1 symptom at the final treatment evaluation.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
2653605|NCT01642212|Secondary|Percent of Participants With Worsened Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation|The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: Improved - participant reported a specific symptom at baseline, but changed to no specific symptom ('Yes' to 'No'); No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report a specific symptom at baseline, but changed to report that specific symptom ('No' to 'Yes').|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
2653606|NCT01642212|Secondary|Percent of Participants With No Change in Symptoms on The EoE Symptom Survey at The Final Treatment Period Evaluation|The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: Improved - participant reported a specific symptom at baseline, but changed to no specific symptom ('Yes' to 'No'); No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report a specific symptom at baseline, but changed to report that specific symptom ('No' to 'Yes').|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
2653607|NCT01642212|Secondary|Percent of Participants With Improved Symptoms on The Eosinophilic Esophagitis (EoE) Symptom Survey at The Final Treatment Period Evaluation|The EoE survey assessed the following symptoms: heartburn, chest pain, regurgitation, abdominal pain, nausea, and vomiting. Participants indicated, by checking a box, if they had a change in symptoms (excluding dysphasia or food impaction) within the past 2 weeks. Baseline was defined as the assessment before randomization. Responses were as follows regarding symptoms at the final treatment evaluation: Improved - participant reported a specific symptom at baseline, but changed to no specific symptom ('Yes' to 'No'); No change - participant reported or did not report a specific symptom at both baseline and the final treatment evaluation; Worsened -participant did not report a specific symptom at baseline, but changed to report that specific symptom ('No' to 'Yes').|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
2653609|NCT01642212|Secondary|Change From Baseline in The Physician's Global Assessment (PGA) of Disease Activity at The Final Treatment Period Evaluation|"The physician Investigator (or qualified physician's assistant or nurse practitioner) completed the PGA to provide the global assessment of eosinophilic esophagitis (EoE) disease activity using a 0 to 100 mm visual analog scale (VAS) scale. The VAS is a 100 mm horizontal line on which the right extreme (100) is labeled worst possible disease activity and the left extreme (0) is labeled no disease activity. The PGA raters were instructed to consider the line for the VAS a continuum with their own medical opinion or judgment of extremes on either end and to draw a vertical line at a point that best approximates the participant's current level of EoE disease activity. A negative change from baseline indicates that disease activity decreased."|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||scores on a scale||Standard Error|Least Squares Mean
2653610|NCT01642212|Secondary|Change From Baseline in The Peak Eosinophil Count at Each Available Esophageal Level at The Final Treatment Period Evaluation|An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value across all available esophagus levels. Histopathology data were collected in a blinded fashion. Baseline was defined as the score at screening. A negative change from baseline indicates that eosinophil count decreased.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||eosinophils/HPF||Standard Error|Least Squares Mean
2653611|NCT01642212|Secondary|Change From Baseline in The Total Endoscopy Score at The Final Treatment Period Evaluation|The gross endoscopic appearance of the esophageal surface was evaluated by a blinded study center physician. Endoscopic findings with separate evaluations of the proximal and distal esophagus were recorded with respect to 5 major categories, including exudates or plaques, fixed esophageal rings, edema, furrows, and strictures. The endoscopy score was the sum of the scores for the 5 major categories - grade 0-1 for strictures; grade 0-2 for exudates or plaques, edema, and furrows; and grade 0-3 for fixed esophageal rings for the proximal and distal locations. The maximum endoscopy score was 10 points for each location (proximal and distal), and the total endoscopy score was the sum of the scores for the proximal and distal locations (maximum total score of 20 points). Baseline was defined as the endoscopy score at screening. A negative change from baseline indicates that appearance improved.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||scores on a scale||Standard Error|Least Squares Mean
2653612|NCT01642212|Secondary|Change From Baseline in The Histopathologic Epithelial Features Combined Total Score at The Final Treatment Period Evaluation|Each esophageal biopsy specimen was evaluated microscopically by an independent, central pathologist for signs of epithelial inflammation and lamina propria fibrosis. Histopathologic epithelial features of each available esophageal level biopsy consisting of basal layer hyperplasia, eosinophil peak, dilated intercellular spaces, eosinophil microabcesses, surface layering, surface alteration, and apoptotic epithelial cells were scored and summed. Histopathology data were collected in a blinded fashion. Histopathology epithelial features were scored for both grade and stage. Each feature had a possible score of 0-3 for grade as well as stage. Thus each of the 3 levels had a possible score of 21, and a possible total grade or stage score of 63 for a maximum combined score of 126. The grade and stage score of the lamina propria was not included because the biopsy material was not available. A negative change from baseline indicates that epithelial inflammation decreased.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||scores on a scale||Standard Error|Least Squares Mean
2653613|NCT01642212|Secondary|Percent of Participants Who Were Overall Responders at The Final Treatment Period Evaluation|Overall response was defined as a reduction in the 2-week DSQ score of >/= 30% and >/= 50% from baseline to the final treatment period evaluation and a peak eosinophil count of </= 6/high power field (light microscopy) (HPF) across all available esophageal levels at the final treatment period evaluation. An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value. Histopathology data were collected in a blinded fashion.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
2653614|NCT01642212|Secondary|Percent of Participants With a >/= 30% And >/= 50% Reduction In The DSQ Score From Baseline to The Final Treatment Period Evaluation|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing).The DSQ score was calculated based on responses to Questions 2 and 3 [14 x (sum of points from Questions 2 and 3 in the daily DSQ)/number of diaries with non-missing data]. Baseline was the DSQ score of the 14-day period before randomization.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
2653615|NCT01642212|Secondary|Percent of Participants With a Peak Eosinophil Count </= 15/High Power Field (Light Microscopy) (HPF) And </= 1/HPF at The Final Treatment Period Evaluation|An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value across all available esophagus levels. Histopathology data were collected in a blinded fashion. The values reported are for participants with histologic response.|Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
2653616|NCT01642212|Secondary|Change From Baseline in The DSQ Score For The 50th Percentile of Participants at The Final Treatment Period Evaluation|A cumulative distribution function curve was constructed to illustrate the cumulative proportion of participants (x-axis) vs. the change in the DSQ score from baseline to the final treatment evaluation (y-axis). The 50th percentile is participants with a DSQ score that is in the middle of the distribution of all scores. A negative change from baseline indicates that symptoms decreased.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||scores on a scale|||Number
2653617|NCT01642212|Secondary|Change From Baseline in The DSQ Score Over Time|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing).The DSQ score was calculated based on responses to Questions 2 and 3 [14 x (sum of points from Questions 2 and 3 in the daily DSQ)/number of diaries with non-missing data]. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.|Baseline, Weeks 8 and 12|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||scores on a scale||Standard Error|Least Squares Mean
2653618|NCT01642212|Primary|Change From Baseline in The Dysphagia Symptom Questionnaire (DSQ) Score at The Final Treatment Period Evaluation|Participants' dysphagia symptoms were evaluated using the 4-item DSQ. The questionnaire was developed by the Sponsor, as an ePRO measure, according to the principles of the Final Guidance for Industry for Patient Reported Outcome Measures (PRO Guidance December 2009). All participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing).The DSQ score was calculated based on responses to Questions 2 and 3 [14 x (sum of points from Questions 2 and 3 in the daily DSQ)/number of diaries with non-missing data]. Baseline was the DSQ score of the 14-day period before randomization. A negative change from baseline indicates that symptoms decreased.|Baseline, Week 16|The MITT Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||scores on a scale||Standard Error|Least Squares Mean
2653619|NCT01642212|Primary|Percent of Participants Who Were Histologic Responders|Histologic response was defined as a peak eosinophil count </= 6/high power field (light microscopy) (HPF) across all esophageal levels at the final treatment evaluation (Week 16). An independent, central pathologist determined the peak eosinophil count from the proximal, mid-, and distal levels and selected the maximum peak value. Histopathology data were collected in a blinded fashion.|Week 16|The modified Intent-to-Treat (MITT) Analysis Set: all randomized participants who received at least 1 dose of double-blind study drug and had both an evaluable post-baseline biopsy during the treatment period and a post-baseline DSQ score. Participants were analyzed based on the randomization schedule, regardless of the treatment actually received.|||percent of participants|||Number
2653620|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||120min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||percentage of oxygen saturation||Standard Deviation|Mean
2653621|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||90min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||percentage of oxygen saturation||Standard Deviation|Mean
2653622|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||60min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||percentage of oxygen saturation||Standard Deviation|Mean
2653623|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||30min after extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||percentage of oxygen saturation||Standard Deviation|Mean
2653624|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||at extubation|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||percentage of oxygen saturation||Standard Deviation|Mean
2653625|NCT01642147|Primary|Oxygen Saturation of Jugular Venous Bulb||before general anesthesia|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||percentage of oxygen saturation||Standard Deviation|Mean
2653631|NCT01642147|Primary|Mean Blood Flow Velocity in Middle Cerebral Artery|It was the baseline mean blood flow velocity in middle cerebral artery.|before general anesthesia|The number of participants for analysis was determined by sample estimation equation of cohort study. In the equation, the hyperemia frequency from literature and pre-study was used.|||cm/s||Standard Deviation|Mean
2653632|NCT01642082|Secondary|Adverse Events (Primary Serious and All Other AEs)|The frequencies of the maximum grade of any acute adverse event, regardless of attribution are reported during treatment and up to 30 days after stopping the study treatment are reported.|Every cycle of study treatment and after treatment for a maximum of 5 years from study entry|Eligible and treated patients|||Participants|||Count of Participants
2653633|NCT01642082|Secondary|Duration of Survival|Duration of survival is defined as the duration alive from study entry until death or last contact.|Patients are followed every three months for the first two years and then every six months for the next three years.|All eligible and treated patients|||months||90% Confidence Interval|Median
2653634|NCT01642082|Secondary|Duration of Progression-free Survival|Progression-free survival is defined as the duration alive from study entry until progression is documented or death, whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.|CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|All eligible and treated patients.|||months||90% Confidence Interval|Median
2653635|NCT01642082|Secondary|Progression-free Survival at 6 Months|"Progression-free survival is defined as the duration alive from study entry until progression is documented or death, whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.~Disease progression within 6 months of study entry or death within 6 months of study entry and prior to disease progression counts as an event for progression-free survival at 6 months."|: CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.|All eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
2653636|NCT01642082|Primary|Treatment and Progression-free Survival at 6 Months|"Treatment and Progression-free Survival is defined as the duration alive from study entry until progression is documented, death or non-protocol treatment is initiated; whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions.~Non-protocol treatment initiation prior to disease progression and prior to 6 months from study entry was counted as an event for treatment and progression-free survival at 6 months. Disease progression within 6 months of study entry or death within 6 months of study entry and prior to disease progression counts as an event for treatment and progression-free survival at 6 months."|CT scan or MRI were to assess progression every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease|All eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
2653637|NCT01642082|Primary|Response|Response was defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and based on imaging done every other cycle. Responses can be either partial or complete. Per RECIST v1.1 target and non-target lesions are assessed by MRI or CT scan: Complete Response (CR), Disappearance of all target and non-target lesions and all lymph nodes must be < 10 mm in short axis; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD.|Scans to assess response were done every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease. Responses must be confirmed.|All eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
2653638|NCT01642004|Primary|Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint|The number of participants who died from any cause was reported for each arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants|||participants|||Number
2653639|NCT01642004|Secondary|Progression Free Survival (PFS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|PFS time was measured for all randomized participants grouped by their baseline PD-L1 expression levels. PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. The PFS curves were estimated using KM method. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started subsequent anti-cancer therapy (including on-treatment palliative radiotherapy of non-target bone lesions or CNS lesions) without a prior reported progression were censored at the last evaluable tumor assessment prior to subsequent anti-cancer therapy. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants|||months||95% Confidence Interval|Median
2653648|NCT01642004|Primary|Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint|OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants|||months||95% Confidence Interval|Median
2653640|NCT01642004|Secondary|Objective Response Rate (ORR) by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|ORR was reported for all randomized participants grouped by their baseline PD-L1 expression level. ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). PD-L1 expression in participants was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2653641|NCT01642004|Secondary|Overall Survival (OS) Time in Months by Baseline PD-L1 Expression for All Randomized Participants at Primary Endpoint|OS was measured in months for all randomized participants grouped by their baseline PD-L1 expression level. PD-L1 expression was defined as the percent of disease tumor cells demonstrating plasma membrane PD-L1 staining of any intensity using an immunohistochemistry (IHC) assay. OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants|||months||95% Confidence Interval|Median
2653642|NCT01642004|Secondary|Percentage of Participants Experiencing Disease-related Symptom Improvement by Week 12|Disease-related symptom improvement rate by Week 12 was defined as the percentage of randomized participants who had a 10 point or greater decrease from baseline in average symptom burden index score at any time between randomization and Week 12. The participant portion of the Lung Cancer Symptom Scale (LCSS) consisted of 6 symptom-specific questions that addressed cough, dyspnea, fatigue, pain, hemoptysis, and anorexia, plus 3 summary items on symptom distress, interference with activity level, and global health-related Quality of Life (QoL). The scores range from 0 to 100, with 0 representing the best possible score and 100 being the worst possible score. The average symptom burden index score at each assessment was defined as the mean of the 6 symptom-specific questions of the LCSS. 95% CIs were computed using Clopper-Pearson Method.|Randomization to Week 12|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2653643|NCT01642004|Secondary|Progression-Free Survival (PFS) Time in Months for All Randomized Participants at Primary Endpoint|PFS was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator per RECIST v1.1 criteria, or death due to any cause. Participants underwent radiographic tumor assessments every 6 weeks (+/- 5 days) from week 9 (+/- 5 days) for the first year on treatment, then every 12 weeks after the first year on treatment until documented disease progression. The PFS curves were estimated using KM method. Two-sided 95% CI for median PFS were computed by Brookmeyer and Crowley method (using log-log transformation). Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including on-treatment palliative RT of non-target bone lesions or CNS lesions) without a prior reported progression were to be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy.|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants (105 PFS events in Nivolumab arm; 122 PFS events in Docetaxel arm)|||months||95% Confidence Interval|Median
2653644|NCT01642004|Secondary|Progression-Free Survival (PFS) at Primary Endpoint|PFS rate was defined as the probability that participants will experience no disease progression or death from any cause at a given time point following randomization. Progression was assessed by investigators according to RECIST v1.1. 95% CIs were estimated using the Kaplan-Meier method. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy (including on-treatment palliative radiation therapy (RT) of non-target bone lesions or CNS lesions) without a prior reported progression were to be censored at the last evaluable tumor assessment prior to or on initiation of the subsequent anti-cancer therapy|Randomization to 12 months post-randomization, up to November 2014|All randomized participants (105 PFS events in Nivolumab arm; 122 PFS events in Docetaxel arm)|||percent probability of PFS||95% Confidence Interval|Number
2653645|NCT01642004|Secondary|Duration of Objective Response (DOR) in Months for All Confirmed Responders at Primary Endpoint|"DOR was defined as the time from the date of first confirmed response to the date of the first documented tumor progression (per RECIST v1.1), as determined by the investigator, or death due to any cause, whichever occurred first. DOR was evaluated only for confirmed responders (i.e. participants with confirmed CR or PR).~CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.~Participants who neither progressed nor died were censored on the date of their last evaluable tumor assessment."|Date of confirmed response to date of documented tumor progression, up to November 2014, approximately 25 months|All confirmed responders (participants demonstrating CR or PR)|||months||95% Confidence Interval|Median
2653646|NCT01642004|Secondary|Time To Response (TTR) in Months for All Confirmed Responders at Primary Endpoint|Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters.|Randomization until confirmed response, up to November 2014, approximately 25 months|All confirmed responders (participants demonstrating CR or PR)|||months||Full Range|Median
2653647|NCT01642004|Primary|Overall Survival (OS) Rate in All Randomized Participants|The overall survival rate is the probability that a participant will be alive at 6, 12, and 18 months following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.|Randomization to 18 months post-randomization, up to June 2015|All randomized participants|||percent probability of OS||95% Confidence Interval|Number
2653649|NCT01642004|Secondary|Objective Response Rate (ORR) in All Randomized Participants at Primary Endpoint|"ORR was defined as the percentage of all randomized participants whose Best Overall Response (BOR) was a confirmed Complete Response (CR) or Partial Response (PR). BOR was defined as the best investigator-assessed response designation, recorded between the date of randomization and the date of objectively documented progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or the date of subsequent anti-cancer therapy (excluding on-treatment palliative radiotherapy of non-target bone lesions or Central Nervous System (CNS) lesions), whichever occurred first.~CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.; PR = At least a 30% decrease in the sum of diameters of target lesions, taking, as reference, the baseline sum diameters. CIs were computed using the Clopper and Pearson method."|Randomization until 199 deaths, up to November 2014, approximately 25 months|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2653650|NCT01642004|Other Pre-specified|Overall Survival (OS) Time in Months for All Randomized Participants at Updated Survival Follow-up|OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Survival follow-up analysis occurred 7.4 months after Primary Endpoint was reached, representing a minimum OS follow-up time of 18.0 months.|Randomization until July 2015, approximately 33 months|All randomized participants|||months||95% Confidence Interval|Median
2653651|NCT01641991|Secondary|TNA NF50 Peak Geometric Mean Titer (GMT) Antibody Response Through Day 100|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. To determine the group peak GMT, the highest titer assessed for each subject at any post vaccination visit through Day 100 was determined. The geometric mean of each subjects' peak titers was calculated along with the 95% confidence intervals.|Day 7 through Day 100|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.|||titer||95% Confidence Interval|Geometric Mean
2653652|NCT01641991|Secondary|Number of Subjects With a Four-fold or Greater Increase From Baseline in Enzyme-linked Immunosorbent Assay (ELISA) Antibody Concentration Against the Protective Antigen (Anti-PA IgG)|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the ELISA assay to determine the anti-PA IgG antibody concentration. A participant met the threshold of a 4-fold rise in anti-PA IgG antibody concentration if the post vaccination concentration was an increase by 4-fold or more from the baseline (Day 0) concentration.|Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.|||participants|||Number
2653653|NCT01641991|Secondary|Number of Participants Reporting Fever in the Eight Days After the 6-month Boost Vaccination by Maximum Severity|Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.|Day 0-7 after vaccination at Month 6|The analysis population includes all participants who received the 6-month boost vaccination and recorded oral temperatures.|||participants|||Number
2653654|NCT01641991|Secondary|Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 28 by Maximum Severity|Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.|Day 0-7 after vaccination at Day 28|The analysis population includes all participants who were vaccinated at Day 28 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
2653655|NCT01641991|Secondary|Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 14 by Maximum Severity|Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.|Day 0-7 after vaccination at Day 14|The analysis population includes all participants who were vaccinated at Day 14 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
2653683|NCT01641939|Secondary|Systemic Clearance (CL) - Stage 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis.|||mL/day/kg||Standard Deviation|Mean
2655214|NCT01628198|Primary|Mean Change in Ambulatory Systolic Blood Pressure|The change in systolic blood pressure as measured by 24 hour ambulatory monitoring at 6 months as compared to from baseline.|baseline and 6 months|analysis for participants who returned for follow up|||mmHg||Standard Deviation|Mean
2653656|NCT01641991|Secondary|Number of Participants Reporting Fever in the Eight Days After Vaccination at Day 0 by Maximum Severity|Participants were given a thermometer with a memory aid to record their oral temperature at least once daily, encouraged to be at the same time each day, but at any time the participant felt they may have a fever. The highest temperature assessed for each day was reported and graded according to the protocol grading scale of severe being greater than or equal to 39 degrees Celsius, moderate 38.5-38.9 degrees Celsius, and mild 38.0-38.4 degrees Celsius. Participants are counted by the maximum severity they reported experiencing fever on any of the 8 days.|Day 0-7 after vaccination at Day 0|The analysis population includes all participants who were vaccinated at Day 0 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
2653657|NCT01641991|Secondary|Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After the 6-month Boost Vaccination by Maximum Severity.|Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after the 6-month intramuscular boost vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Month 6|The analysis population includes all participants who received the 6-month boost vaccination.|||participants|||Number
2653658|NCT01641991|Secondary|Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 28 by Maximum Severity.|Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 28|The analysis population includes all participants who were vaccinated at Day 28 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
2653659|NCT01641991|Secondary|Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 14 by Maximum Severity.|Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 14|The analysis population includes all participants who were vaccinated at Day 14 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
2653660|NCT01641991|Secondary|Number of Participants Reporting Solicited Subjective Systemic Symptoms for Eight Days After Vaccination at Day 0 by Maximum Severity.|Participants maintained a memory aid to record daily the occurrence of solicited systemic reactions of fatigue, muscle aches, and headache for 8 days after vaccination based on their interference with daily activities. Severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 0|The analysis population includes all participants who were vaccinated at Day 0 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
2653661|NCT01641991|Secondary|Peak Geometric Mean Concentration (GMC) of ELISA Anti-PA IgG Antibody Through Day 100|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the ELISA assay to determine the anti-PA IgG antibody concentration. To determine the group peak GMC, the highest antibody concentration assessed for each subject at any post vaccination visit through Day 100 was determined. The geometric mean of subjects' peak concentrations was calculated along with the 95% confidence intervals.|Day 7 through Day 100|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.|||µg/mL||95% Confidence Interval|Geometric Mean
2653662|NCT01641991|Secondary|TNA NF50 Geometric Mean Titers (GMT) at Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. The geometric mean of subjects' visit-specific titers were calculated along with the 95% confidence intervals. If the antibody titer was below the lower limit of quantification (LLOQ) for the assay, half the value of LLOQ (0.03) was imputed. When all subjects' titers were below LLOQ resulting in no variability within the group, the 95% CI was not calculated.|Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.|||titer||95% Confidence Interval|Geometric Mean
2653684|NCT01641939|Secondary|Volume of Distribution at Steady State (Vss) - Stage 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis.|||milliliter per kilogram (mL/kg)||Standard Deviation|Mean
2653663|NCT01641991|Secondary|Number of Participants With Injection Site Edema and Erythema With a Size of Greater Than 120 Millimeters (mm)|Participants were given a ruler with the memory aid to measure the occurrence of edema (swelling) and erythema (redness) daily for at least 8 days after each vaccination. Participants are counted in this outcome measure if they had measurements of greater than 120 mm in the 8-day period after at least one vaccination, first separately for edema and erythema, and in the last category, edema and/or erythema, if they had either or both reactions of greater than 120 mm.|Days 0-7 after each vaccination|The analysis population includes all participants who were vaccinated per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
2653664|NCT01641991|Secondary|Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following the 6-month Boost by Maximum Severity|Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after the 6-month intramuscular boost vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Month 6|The analysis population includes all participants who received the 6-month booster vaccination.|||participants|||Number
2653665|NCT01641991|Secondary|Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 28 by Maximum Severity|Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 28|The analysis population includes all participants who were vaccinated at Day 28 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
2653666|NCT01641991|Secondary|Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 14 by Maximum Severity|Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 14|The analysis population includes all participants who were vaccinated at Day 14 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
2653667|NCT01641991|Secondary|Number of Participants Reporting Solicited Injection Site Reactogenicity Symptoms in the Eight Days Following Vaccination at Day 0 by Maximum Severity|Participants maintained a memory aid to record daily the occurrence of local reactions for 8 days after vaccination based on their interference with daily activities (pain, itchiness, warmth, and tenderness at injection site, arm motion limitation) or based on a quantitative measurement of the reaction (edema, erythema). In the subjective grading scale, severe reactions prevented daily activities, moderate reactions interfered with but did not prevent daily activities, and mild reactions did not interfere with daily activities. For the quantitative scale, severe reactions greater than 100 millimeters (mm), moderate reactions were 51-100 mm, and mild reactions were 25-50 mm. Participants are counted by the maximum severity they reported experiencing the reaction on any of the 8 days.|Days 0-7 after vaccination at Day 0|The analysis population includes all participants who were vaccinated at Day 0 per protocol, excluding 59 participants at one clinic site who were vaccinated in the fatty tissue over the triceps rather than the intended inferior deltoid.|||participants|||Number
2653668|NCT01641991|Secondary|Geometric Mean Concentration (GMC) of Enzyme-linked Immunosorbent Assay (ELISA) Antibody Against the Protective Antigen (Anti-PA IgG)|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the ELISA assay to determine the anti-PA IgG antibody concentration. The geometric mean of subjects' visit-specific titers were calculated along with the 95% confidence intervals. If the antibody titer was below the lower limit of quantification (LLOQ) for the assay, half the value of LLOQ (4.64) was imputed. When all subjects' titers were below LLOQ resulting in no variability within the group, the 95% CI was not calculated.|Days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84 and 100.|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.|||µg/mL||95% Confidence Interval|Geometric Mean
2653685|NCT01641939|Secondary|Plasma Decay Half-Life (t1/2) - Stage 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis.|||days||Standard Deviation|Mean
2653669|NCT01641991|Primary|Number of Participants With a Four-fold or Greater Increase From Baseline in Toxin Neutralization Antibody Assay (TNA) 50 Percent Neutralization Factor ( NF50 ) Antibody Titer|Blood was collected from all participants prior to vaccination and at scheduled follow up visits weekly through Day 70, at Day 84 and at Day 100 for testing in the toxin neutralization antibody assay to determine the NF50 antibody titer. A participant met the threshold of a 4-fold rise in NF50 antibody titer if the post vaccination titer was an increase by 4-fold or more from the baseline (Day 0) titer.|Days 0, 7, 14, 21, 28 35, 42, 49, 56, 63, 70, 84 and 100|The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all doses in the primary series, completed all scheduled visits up to and including the Day 100 visit in-window, and who contributed both pre- and post-vaccination blood samples for testing for which valid results were reported.|||participants|||Number
2653670|NCT01641978|Secondary|Years of Professional Experience for Nurses in Critical Care|Influence of professional experience in the evaluation of neurological patients|1 year|Nurses with a minimum experience of three years in intensive care|||years||Inter-Quartile Range|Median
2653671|NCT01641978|Secondary|Severity in Glasgow Coma Scale (GCS) by Groups.|"The Glasgow Coma Scale is divided into three components which are scored separately: ocular response (assessment 1-4 points), motor response (assessment 1-6 points) verbal response (evaluation of 1-5 points).~Scores for each component are added together to get the total that will range between a minimum of 3 points (which corresponds to a patient who does not open his eyes and no motor response to stimulation or verbal response) and a maximum value of 15 points (corresponding to a patient with open eyes, obeying orders and maintaining a consistent language).~It has been considered that the GCS score between 15 and 13 points corresponds to a slight alteration of consciousness, a score of 12-9 points with moderate impairment and 8 points or less with a serious deterioration in level of consciousness."|1 year|Neurological and/or neurosurgical patients in ICU|||percentage of correlation||95% Confidence Interval|Number
2653672|NCT01641978|Primary|Interobserver Correlation|interobserver agreement of the Glasgow Coma Scale (GCS) among ICU nurses measured by the intraclass correlation coefficient (ICC) with confidence interval (CI) 95%|1 year||||percentage of correlation||95% Confidence Interval|Number
2653673|NCT01641952|Secondary|Health Assessment Questionnaire (HAQ) Score at Week 20|HAQ is a self-completed patient questionnaire specific for rheumatoid arthritis (RA). It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Calculate HAQ the patient must have a domain score for at least 6 of 8 domains. The HAQ is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.|Baseline and Week 20|Intent to treat population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated to the screening exam, and have completed the baseline visit and at least one further assessment. Here, number of participant analysed is the participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2653674|NCT01641952|Primary|Number of Participants With Adverse Events (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 39 months|Safety population included all participants who received at least one dose of study treatment.|||participants|||Number
2653675|NCT01641952|Primary|Number of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course for Subgroup of Participants Who Had Been Treated With Etanercept or Adalimumab or Infliximab Before Rituximab|The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative change from Baseline (CFB) indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||participants|||Number
2653676|NCT01641952|Primary|Percentage of Participants With Remission (DAS28 <2.6) and Low Disease Activity Following Each Treatment Course|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2653686|NCT01641939|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] - Stage 1|AUCinf= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis.|||day*mcg/mL||Standard Deviation|Mean
2653677|NCT01641952|Primary|Percentage of Participants With EULAR Response in Subgroup of Participants Who Had Been Treated With Anti-TNF Previously|The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative CFB indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2653678|NCT01641952|Primary|Percentage of Participants With EULAR Response|The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative CFB indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of CFB and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2653679|NCT01641952|Primary|Percentage of Participants With Change in DAS28-ESR of Greater Than or Equal (>=) 1.2 After First Course of Treatment|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2653680|NCT01641952|Primary|Mean DAS28-ESR Score at Visit 4 (Week 20)|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2653681|NCT01641952|Primary|Change From Baseline in DAS28-ESR at Week 20|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [ml/hr]), and Patient's Global Assessment (PGH) of disease activity [measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity]. DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Baseline and Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||units on a scale||95% Confidence Interval|Mean
2653682|NCT01641952|Primary|Percentage of Participant With Good or Moderate Response According to European League Against Rheumatism (EULAR) Response Criteria|The DAS28 score is a measure of the participant's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to 10. DAS28 <=3.2 indicates low disease activity, DAS28 >3.2 to 5.1 indicates moderate to high disease activity. A negative change from Baseline indicates improvement. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) and the level of disease activity reached. Good response: DAS28 <=3.2 and a CFB >1.2. Moderate response: DAS28 <=3.2 and CFB >0.6 to <=1.2, DAS28 >3.2 to <=5.1 and CFB >1.2 or >0.6 to <=1.2, DAS28 >5.1 and CFB >1.2. No response: DAS28 <=3.2 and CFB >=0.6, DAS28 >3.2 to <=5.1 and CFB <=0.6, DAS28 >5.1 and CFB >0.6 to <=1.2 or <=0.6.|Week 20|Full analysis population included all participants who has fulfilled the eligibility criteria, and signed the informed consent form, participated at the screening examination. Here, number of participants analyzed is the participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2653687|NCT01641939|Secondary|Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 2|Stage 2 consists of all participants recruited after the regimen selection decision up to primary data cut-off date 30-June-2015.|C1D1; C4D1|Participants who had at least one PK parameter estimated were included for analysis. Here, n=number of participants evaluable at specified timepoint.|||mcg/mL||Standard Deviation|Mean
2653688|NCT01641939|Secondary|Maximum Observed Plasma Concentration (Cmax) of N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1) - Stage 1|Maximum observed plasma concentration of DM1 were reported. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.|C1D1 and C1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis. Here, n=number of participants evaluable at specified timepoint.|||nanogram per milliliter (mcg/mL)||Standard Deviation|Mean
2653689|NCT01641939|Secondary|Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 1|Maximum observed plasma concentration of Trastuzumab Emtansine (T-DM1) and total trastuzumab were reported. Stage 1 consists of all participants recruited before the regimen selection, which was carried out after 12 weeks of randomization.|Day 1 (D1) of Cycle 1 (C1) and C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)|Participants who had at least one PK parameter estimated were included for analysis. Here, n=number of participants evaluable at specified timepoint.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2653690|NCT01641939|Secondary|Time to Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3|Time to AGC symptom were defined as the time from randomization to the first documentation of an increase in at least one of the pre-specified abdominal discomfort, loss of appetite, weakness and fatigue, upper abdominal pain, change in bowel movement, and weight loss subscales of the QLQ STO22 and EORTC QLQ-C30. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants evaluable for this measure.|||months||95% Confidence Interval|Median
2653691|NCT01641939|Secondary|Percentage of Participants With Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3|AGC symptomatic progression: a worsening of >=10-points in any 1 of the abdominal discomfort, loss of appetite, weakness and fatigue, upper abdominal pain, change in bowel movement, and/or weight loss scales of the EORTC QLQ-C30 and QLQ-STO22. QLQ-STO22 supplements EORTC QLQ-C30 to assess symptoms and commonly reported treatment-related side effects. There are 22 questions comprise 5 scales (dysphagia, pain, reflux symptom, diet restrictions, anxiety), 4 single items (dry mouth, hair loss, taste, body image), which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'). All scores and single-items transformed to a scale of 0-100; higher score=better level of functioning or greater degree of symptoms. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants evaluable for this measure.|||percentage of participants|||Number
2653692|NCT01641939|Secondary|Percentage of Participants With Clinically Significant Improvement in Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) Score - Phase 3|The Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) supplements the EORTC QLQ-C30 to assess symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. Change of >=10 points has been found to be clinically significant. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants with baseline and at least one post-baseline valid score.|||percentage of participants||95% Confidence Interval|Number
2653693|NCT01641939|Secondary|Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3|The EORTC QLQ-C30 is a validated, cancer-specific 30-item patient-reported measure, and contains 14 domains to assess the impact of cancer treatment on 5 aspects of participants functioning (physical, role, cognitive, emotional, and social), 9 aspects of disease/treatment-related symptoms (fatigue, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation, diarrhea) and a global QoL/overall health status scale. Questions used 4 point scale (1 'Not at all' to 4 'Very much'; with the exception of the QoL/health status scale which uses a 7-point scale (1 'very poor' to 7 'Excellent'). Each scale is transformed on a scale of 0-100; a higher score equals (=) a better level of functioning or greater degree of symptoms. Change of greater than or equal to (>=) 10-points has been found to be clinically significant. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at follow-up (up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants with baseline and at least one post-baseline valid score.|||percentage of participants||95% Confidence Interval|Number
2653791|NCT01641640|Secondary|Percentage of Participants With Viral Breakthrough|Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.|Baseline to Week 12|Full Analysis Set|||percentage of participants|||Number
2653694|NCT01641939|Secondary|Duration of Objective Response (DOR) - Phase 3|DOR: time from the date when a clinical response [CR or PR] was first documented to the date of first documented progressive disease (PD) or death. CR:disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: >= 30% decrease in sum of the LD of all target lesions taking as reference the screening sum LD. PD: could base on symptom deterioration or at least a 20% increase in the sum of diameters of target or non-target lesions and new lesions, taking as reference the smallest sum on study (nadir), including baseline. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2653695|NCT01641939|Secondary|Percentage of Participants With Objective Response According to mRECIST v1.1 - Phase 3|Objective response referred to participants with complete response (CR) or partial response (PR). CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: greater than or equal to (>=) 30% decrease in sum of the longest diameter (LD) of all target lesions taking as reference the screening sum LD. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)|ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants with measurable disease were included in analysis of this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2653696|NCT01641939|Secondary|Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3|Progression-free survival was defined as the time between the date of randomization and the first date of documented progression or date of death due to any cause, whichever occurred first. Tumor assessment was performed using modified RECIST v1.1. Progressive disease could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for analysis. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. The confirmatory analyses are restricted to comparisons between the taxane arm and the selected trastuzumab emtansine arm (2.4 mg).|Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)|ITT population included all randomized participants; participants grouped according to the therapy they were randomized to receive.|||months||95% Confidence Interval|Median
2653697|NCT01641939|Secondary|Percentage of Participants With Disease Progression or Death According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3|Progressive disease could base on symptom deterioration or was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Tumor assessment was performed using modified RECIST v1.1. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.|Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)|ITT population included all randomized participants; participants grouped according to the therapy they were randomized to receive.|||percentage participants|||Number
2653698|NCT01641939|Primary|Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study)|Overall survival was defined as the time between the date of randomization and date of death due to any cause. Kaplan-Meier estimates were used for analysis. Participants for whom no death was reported prior to an analysis cutoff (10 August 2013) was censored at the latest date before the cutoff in which they were known to be alive.|Date of randomization until death (up to 1 year)|Analysis population included all participants that had been enrolled in phase 2 (stage 1) up to a clinical cut-off date of 10 August 2013; participants grouped according to the therapy they were randomized to receive. Here, N (number of participants analyzed)=number of evaluable participants during phase 2 up to 10 August 2013.|||weeks||95% Confidence Interval|Median
2653699|NCT01641939|Primary|Overall Survival (OS)- Phase 3|Overall survival was defined as the time between the date of randomization and date of death due to any cause. Kaplan-Meier estimates were used for analysis. Participants for whom no death was reported prior to an analysis cutoff (30 June 2015) was censored at the latest date before the cutoff in which they were known to be alive. All data from the standard taxane therapy and trastuzumab emtansine 2.4 mg (selected treatment arm) from phase 2 and phase 3 (Stage 2) are combined into phase 3 data, and thus cumulative data are provided within the results presented for phase 3. The confirmatory analyses are restricted to comparisons between the taxane arm and the selected trastuzumab emtansine arm (2.4 mg).|Date of randomization until death (up to 2 years 3 months)|ITT population included all randomized participants; participants grouped according to the therapy they were randomized to receive.|||months||95% Confidence Interval|Median
2653771|NCT01641692|Primary|Urine pH on Day 14 of Each Treatment Period|Urine samples were collected for the measurement of urine pH by dipstick method at Day 14. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).|Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2653700|NCT01641926|Secondary|Percentage of HBeAg(+) Participants Achieving the Combined Response of HBeAg Seroconversion and HBV DNA <2000 IU/mL at 24 Weeks Post-treatment|HBeAg seroconversion was defined as loss of HBeAg in HBeAg(+) participants and development of antibody to HBeAg. HBV DNA levels in blood were measured by the Roche COBAS TaqMan HBV-(High Pure System Assay). The percentage of HBeAg(+) participants with the combined response of achieving both HBeAg conversion and HBV DNA levels <2000 IU/mL at 24 weeks post-treatment was reported.|FU Week 24 (Study Week 72)|All randomized HBeAg(+) participants who received ≥1 dose of study medication. HBeAg(-) participants were not included in this analysis.|||percentage of participants|||Number
2653701|NCT01641926|Secondary|Percentage of HBeAg(+) and HBeAg(-) Participants Achieving Alanine Aminotransferase (ALT) Normalization at 24 Weeks Post-treatment|ALT normalization is a desired goal of HBV treatment, which is defined as having abnormal ALT levels at baseline and subsequently normal ALT levels after receiving treatment, where normal is defined as ≤ 1x the upper limit of normal (ULN). The percentage of HBeAg(+) and HBeAg(-) participants achieving ALT normalization at 24 weeks post-treatment was reported.|FU Week 24 (Study Week 72)|All randomized HBeAg(+) and HBeAg(-) participants who received ≥1 dose of study medication.|||percentage of participants|||Number
2653702|NCT01641926|Secondary|Percentage of HBeAg(+) Participants Achieving HBV DNA <2000 IU/mL at 24 Weeks Post-treatment|The Roche COBAS TaqMan HBV-(High Pure System Assay) was used to measure HBV DNA in blood samples of HBeAg(+)participants. The percentage of HBeAg(+) participants with HBV DNA <2000 IU/mL at 24 weeks post-treatment was reported.|FU Week 24 (Study Week 72)|All randomized HBeAg(+) participants who received ≥1 dose of study medication. HBeAg(-) participants were not included in this analysis.|||percentage of participants|||Number
2653703|NCT01641926|Primary|Percentage of HBeAg(-) Participants Achieving Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels <2000 IU/mL at 24 Weeks Post-treatment|The Roche COBAS TaqMan HBV-(High Pure System Assay) was used to measure HBV DNA in blood samples of HBeAg(-) participants. The percentage of HBeAg(-) participants with HBV DNA <2000 IU/mL at 24 weeks post-treatment was reported.|FU Week 24 (Study Week 72)|All randomized HBeAg(-) participants who received ≥1 dose of study medication. HBeAg(+) participants were not included in this analysis.|||percentage of participants|||Number
2653704|NCT01641926|Primary|Percentage of HBeAg(+) Participants Achieving HBeAg Seroconversion at 24 Weeks Post-treatment|Blood samples were drawn to assess the participant's seroconversion status at Follow-up (FU) Week 24. HBeAg seroconversion was defined as loss of HBeAg in HBeAg(+) participants and development of antibody to HBeAg.|FU Week 24 (Study Week 72)|All randomized HBeAg(+) participants who received ≥1 dose of study medication. HBeAg(-) participants were not analyzed for HBeAg seroconversion.|||percentage of participants|||Number
2653705|NCT01641900|Secondary|Motor Procedural Memory Performance|Overnight performance improvement on the finger tapping motor sequence task (MST).The MST involves pressing four numerically labeled keys on a standard keyboard with the fingers of the left hand, repeating a 5 digit sequence as quickly and accurately as possible for 12 trials at 30 seconds each separated by 30 sec rest periods. Different sequences were employed for the Placebo and Drug visits in a counter-balanced order. MST performance is measured as the number of correctly typed sequences in each trial. The primary outcome measure is overnight improvement calculated as the percent increase in average of correct sequences from the last three training trials to the average of first three test trials. Since the outcome measure is calculated as percent improvement from training to test for each participant, there is no highest or lowest possible score.|Experimental Night (Night 2)||||percentage of improvement on MST perform||Standard Deviation|Mean
2653706|NCT01641900|Primary|Sleep Spindle Density|This measure is averaged for Baseline and Experimental nights. Sleep spindle density (number/minute) for non-Rapid Eye Movement Stage 2 sleep (N2) detected at channel Cz based on polysomnographic recordings.|Spindles will be averaged for the Baseline (Night 1) and Experimental Nights (Night 2)||||Sleep spindle density (number/minutes)||Standard Deviation|Mean
2653707|NCT01641861|Secondary|Time Use for Caries Removal|The time taken for the removal of carious dentine was recorded using a stopwatch. Recorded time unit is seconds.|Immediately while treatment||||seconds||Inter-Quartile Range|Median
2653708|NCT01641861|Secondary|Levels of Pain and Discomfort|The participants were assessed for the levels of pain and discomfort using the facial visual analogue scale (VAS). The score was recorded in ruler scale from 0-100 millimeters, 0 = no pain and 100 = extreme pain) before treatment with the child sitting on the dental chair and after treatment (completion of carious tissue removal). The difference in the VAS scores before and after treatment was calculated and compared between the two comparison groups.|immediately after treatment||||Pain score from 0-100||Inter-Quartile Range|Median
2653709|NCT01641861|Secondary|Number of Participants With Complete Caries Removal|"The efficacy of caries removal was evaluated by the visual and tactile criteria. The completeness of caries removal was judged on the basis of clinical criteria involving the inspection of the tooth surfaces using a good light source, dental mirror and explorer. A blunt explorer was used to detect surface roughness by gently stroking across the dentine surfaces and to evaluate the dentine hardness. Complete caries removal was achieved if as remove soft and infected dentine until felt hard and leathery consistency of the dentine surfaces. The tactile criteria include the smooth passage of the blunt explorer and absence of a catch or a tug-back sensation."|immediately after treatment||||participants|||Number
2653710|NCT01641861|Secondary|Incidence of Secondary Caries|The restoration teeth were assess by clinical and radiographic examination for detection the recurrent caries.|two years||||participants|||Number
2653711|NCT01641861|Primary|Number of Participants With Treatment Failure|The dental restorations were evaluated at 6, 12, 18 and 24 months after treatment. Evaluation criteria included the condition of the filling material and presence of secondary caries at the margin of the restorations. The restoration status was re-categorized as a binary outcome: Treatment failure (Yes/No).|two years||||participants|||Number
2653712|NCT01641835|Primary|Bruch's Membrane Opening - Minimum Rim Area, Global||3 months||||microns^2||Standard Deviation|Mean
2653713|NCT01641835|Primary|Primary Endpoints|The primary endpoints are the structural measurement values of (1) the ONH, (2) the peri-papillary RNFL, and (3) the macula obtained using the Spectralis OCT and the statistical descriptors such as mean, standard deviation, and distribution percentiles.|3 months||||microns||Standard Deviation|Mean
2653792|NCT01641640|Secondary|Percentage of Participants Achieving SVR24|SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy|Posttreatment Week 24|Full Analysis Set|||percentage of participants|||Number
2653714|NCT01641822|Secondary|Average Change From Baseline in the CFQ-R Respiratory Symptom Scale (RSS) Score Across All Courses of AZLI/Placebo Treatment (Weeks 4, 12 and 20)|Respiratory symptoms (eg, coughing, congestion, wheezing) were assessed with the Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS). The range of scores (units) was 0 to 100 with higher scores indicating fewer symptoms. The adjusted mean is from a mixed-effect model repeated measures (MMRM) analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Comparative Phase: Baseline and Weeks 4, 12 and 20|Participants in the ITT Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2653715|NCT01641822|Secondary|Rate of Hospitalizations for a Respiratory Event|The rate of hospitalizations for a respiratory event per participant year was calculated using negative binomial regression analysis.|Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)|ITT Analysis Set|||hospitalizations per participant year|||Number
2653716|NCT01641822|Secondary|Time to First Protocol-defined Pulmonary Exacerbation|The time to first protocol-defined pulmonary exacerbation was calculated using the Kaplan-Meier method.|Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)|ITT Analysis Set|||days||95% Confidence Interval|Median
2653717|NCT01641822|Secondary|Percentage of Participants Who Used Non-study IV or Inhaled Antibiotics for PDEs||Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)|ITT Analysis Set|||percentage of participants|||Number
2653718|NCT01641822|Secondary|Average Actual Change From Baseline in FEV1 % Predicted Across All Courses of AZLI/Placebo Treatment (Weeks 4, 12 and 20)|FEV1 % predicted is defined as FEV1 of the patient divided by the average FEV1 in the population for any person of similar age, sex and body composition. The adjusted mean is from a mixed-effect model repeated measures (MMRM) analysis. The model includes terms for baseline value, previous exacerbations (1, 2, ≥ 3), treatment, visit (categorical), and treatment by visit interaction.|Comparative Phase: Baseline and Weeks 4, 12 and 20|Participants in the ITT Analysis Set with available data were analyzed.|||percentage of FEV1 % predicted||Standard Error|Mean
2653719|NCT01641822|Primary|Rate of Protocol-defined Exacerbations (PDE) From Baseline Through Week 24|PDEs were characterized by a change or worsening from baseline of 1 or more documented signs or symptoms (decreased exercise tolerance, increased cough, increased sputum or chest congestion, decreased appetite, or other signs or symptoms) associated with the use of non-study IV or inhaled antibiotics and be verified by a blinded independent adjudication committee.|Baseline in the comparative phase to the end of study (average time on study during the Comparative Phase: 155.4 days)|Intent-to-Treat (ITT) Analysis Set: all randomized participants|||PDEs per participant year|||Number
2653720|NCT01641809|Secondary|Ctau for Rilpivirine|Data was not collected for analysis of rilpivirine PK parameters.|pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36|PK Summary Population. Data were not collected for rilpivirine PK parameters since this drug has been approved already for treatment and the PK of the drug has been well characterized||||||
2653721|NCT01641809|Secondary|Cmax for Rilpivirine|Data was not collected for analysis of rilpivirine PK parameters.|pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36|PK Summary Population. Data were not collected for rilpivirine PK parameters since this drug has been approved already for treatment and the PK of the drug has been well characterized||||||
2653722|NCT01641809|Secondary|AUC(0 to Tau) for Rilpivirine|Data was not collected for analysis of rilpivirine PK parameters.|pre-dose and 2 to 4 hours post-dose at Weeks 26 and 36|PK Summary Population. Data were not collected for rilpivirine PK parameters since this drug has been approved already for treatment and the PK of the drug has been well characterized||||||
2653723|NCT01641809|Secondary|Concentration at the End of a Dosing Interval (Ctau) for GSK1265744 at Week 2|Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.|pre-dose, 1, 2, 3, 4, 8 and 24 hours post dose at Week 2|PK Summary Population. Only those participants with data available at the specified time points were analyzed.|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2653724|NCT01641809|Secondary|Maximum Observed Concentration (Cmax) for GSK1265744 at Week 2|Blood samples for PK analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis.|pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2|PK Summary Population|||Micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2653725|NCT01641809|Secondary|Area Under the Concentration Time Curve Over the Dosing Interval (AUC[0-tau]) for GSK1265744 at Week 2|Blood samples for pharmacokinetic (PK) analysis were collected at the indicated time points. The PK parameters were calculated by standard non-compartmental analysis. The PK Summary Population comprised of all participants who received GSK1265744 or with Rilpivirine, underwent intensive and/or limited/sparse PK sampling during the study, and provided evaluable GSK1265744 and Rilpivirine plasma concentration data|pre-dose, 1, 2, 3, 4, 8 and 24 hours post-dose at Week 2|PK Summary Population|||Hours*micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2653726|NCT01641809|Secondary|Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Maintenance Phase|AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.|Week 24 to Week 96|Maintenance Safety Population|||Percentage of participants|||Number
2653727|NCT01641809|Secondary|Percentage of Participants Who Discontinued Treatment Due to Adverse Events-Induction Phase|AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.|Up to Week 24|Safety Population|||Percentage of participants|||Number
2653790|NCT01641640|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.|End of treatment to post-treatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2653728|NCT01641809|Secondary|Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Induction Phase|Blood samples were collected for the analysis of following hematology parameters: APTT, basophils, eosinophils, hematocrit, hemoglobin, INR, lymphocytes, mean corpuscle volume (MCV), monocytes, platelet count, PT, red blood cell (RBC) count, total neutrophils and WBC count. A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.|Up to Week 24|Safety Population|||Participants|||Count of Participants
2653729|NCT01641809|Secondary|Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicity-Induction Phase|Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, chloride, cholesterol, CK, creatinine, glucose, high density lipoprotein (HDL) cholesterol, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin, triglycerides and urea/blood urea nitrogen (BUN). A toxicity was considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.|Up to Week 24|Safety Population|||Participants|||Count of Participants
2653730|NCT01641809|Secondary|Number of Participants With AEs and SAEs-Induction Phase|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia.|Up to Week 24|Safety Population|||Participants|||Count of Participants
2653731|NCT01641809|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings|Twelve lead ECG was performed after the participants had rested in a semi-supine position for at least 5 minutes using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for worst case results at any time on-treatment is presented.|Up to Week 324|Safety Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2653732|NCT01641809|Secondary|Percentage of Participants Who Discontinued Investigational Product Due to Adverse Events|AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The percentage of participants with adverse events leading to withdrawal/permanent discontinuation of investigational product is presented.|Up to Week 324|Safety Population|||Percentage of participants|||Number
2653733|NCT01641809|Secondary|Change From Baseline in Total Neutrophils, Platelet Count and WBC Count Over Time by Visit|Blood samples were collected for the analysis of total neutrophils, platelet count and WBC count. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324|Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Giga cells per liter||Standard Deviation|Mean
2653734|NCT01641809|Secondary|Change From Baseline in Hemoglobin Level Over Time by Visit|Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324|Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Grams per liter||Standard Deviation|Mean
2653735|NCT01641809|Secondary|Change From Baseline in Estimated Creatinine Clearance Over Time by Visit|Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60, 96, 180, 204, 252 and 264|Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Milliliters per minute||Standard Deviation|Mean
2653736|NCT01641809|Secondary|Change From Baseline in Creatinine and Total Bilirubin Over Time by Visit|Blood samples were collected for the analysis of creatinine and total bilirubin. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324|Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Micromoles per liter||Standard Deviation|Mean
2653793|NCT01641640|Secondary|Percentage of Participants Achieving SVR4|SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy|Posttreatment Week 4|Full Analysis Set|||percentage of participants|||Number
2653737|NCT01641809|Secondary|Change From Baseline in ALT, AST and CK Over Time by Visit|Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324|Safety Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||International Units per Liter||Standard Deviation|Mean
2653738|NCT01641809|Secondary|Absolute Values for Platelet Count, Total Neutrophils and WBC Count During Double-blind Randomized Treatment Until Week 96|Blood samples were collected for the analysis of platelet count, total neutrophils (T. neutrophils) and WBC count. Baseline value is the last pre-treatment value observed.|Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Giga cells per liter||Standard Deviation|Mean
2653739|NCT01641809|Secondary|Absolute Values for Hemoglobin During Double-blind Randomized Treatment Until Week 96|Blood samples were collected for the analysis of hemoglobin level. Baseline value is the last pre-treatment value observed.|Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Grams per liter||Standard Deviation|Mean
2653740|NCT01641809|Secondary|Absolute Values for Estimated Creatinine Clearance During Double-blind Randomized Treatment Until Week 96|Blood samples were collected for the analysis of estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft-Gault formula. Baseline value is the last pre-treatment value observed.|Baseline (Day 1), Weeks 2, 4, 8, 16, 20, 24, 26, 40, 48, 60 and 96|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Milliliters per minute||Standard Deviation|Mean
2653741|NCT01641809|Secondary|Absolute Values for Creatinine and Total Bilirubin During Double-blind Randomized Treatment Until Week 96|Blood samples were collected for the analysis of creatinine and total bilirubin (T. bilirubin). Baseline value is the last pre-treatment value observed.|Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Micromoles per liter||Standard Deviation|Mean
2653742|NCT01641809|Secondary|Absolute Values for ALT, AST, CK During Double-blind Randomized Treatment Until Week 96|Blood samples were collected for the analysis of ALT, AST and CK. Baseline value is the last pre-treatment value observed.|Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96|Safety Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||International Units per Liter||Standard Deviation|Mean
2653743|NCT01641809|Secondary|Number of Participants With Maximum Treatment-emergent Hematology Toxicities Over Time|Blood samples were collected for the analysis of following hematology parameters: APTT, hemoglobin, INR, platelet count, PT, total neutrophils and WBC count. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.|Up to Week 324|Safety Population|||Participants|||Count of Participants
2653744|NCT01641809|Secondary|Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities Over Time|Blood samples were collected for the analysis of following clinical chemistry parameters: ALT, albumin, ALP, AST, CO2/bicarbonate, cholesterol, CK, creatinine, glucose, LDL cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.|Up to Week 324|Safety Population|||Participants|||Count of Participants
2653745|NCT01641809|Secondary|Number of Participants With AEs and SAEs Over Time|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Safety Population comprised of all randomized participants who were exposed to investigational products with the exception of any participants with documented evidence of not having consumed any amount of investigational product.|Up to Week 324|Safety Population|||Participants|||Count of Participants
2653746|NCT01641809|Secondary|Number of Participants With Maximum Treatment-emergent Hematology Toxicities-Maintenance Phase|Blood samples were collected for the analysis of following hematology parameters: Activated Partial Thromboplastin Time (APTT), hemoglobin, international normalized ratio (INR), platelet count, prothrombin time (PT), total neutrophils and white blood cell (WBC) count. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.|Week 24 to Week 96|Maintenance Safety Population|||Participants|||Count of Participants
2653754|NCT01641809|Secondary|Change From Baseline in CD4+ Cell Count Over Time by Visit|CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324|ITT-E Population.Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Cells per cubic millimeter||Standard Deviation|Mean
2653747|NCT01641809|Secondary|Number of Participants With Maximum Treatment-emergent Clinical Chemistry Toxicities-Maintenance Phase|Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotranferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), carbon dioxide(CO2)/bicarbonate, cholesterol, creatine kinase (CK), creatinine, glucose, low density lipoprotein (LDL) cholesterol, lipase, inorganic phosphorus, potassium, sodium, total bilirubin and triglycerides. A toxicity is considered treatment emergent if it developed or increased in intensity from Baseline while on-treatment. Laboratory toxicities were graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, where Grade 1=Mild, Grade 2=moderate, Grade 3=severe and Grade 4=potentially life-threatening.|Week 24 to Week 96|Maintenance Safety Population|||Participants|||Count of Participants
2653748|NCT01641809|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Maintenance Phase|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes mentioned before; all events of possible drug-induced liver injury with hyperbilirubinemia. Maintenance Safety Population comprised of all participants randomized to GSK1265744 and who were exposed to investigational products during the maintenance phase of the study with the exception of any participants with documented evidence of not having consumed any amount of investigational product.|Week 24 to Week 96|Maintenance Safety Population|||Participants|||Count of Participants
2653749|NCT01641809|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL From Week 24 Through Week 96 by Visit Using MSDF Algorithm-Maintenance Phase|Plasma samples were collected for quantitative analysis of HIV-1 RNA. The end point was determined using MSDF algorithm based on the current US FDA definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-Maintenance Exposed (ME) Population comprised of all participants randomized to GSK1265744 and who received at least one dose of investigational product during maintenance phase of the study.|Weeks 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96|ITT-ME Population|||Percentage of participants|||Number
2653750|NCT01641809|Secondary|Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 16 and Week 24 Using MSDF Algorithm-Induction Phase|Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.|Week 16 and Week 24|ITT-E Population|||Percentage of participants||95% Confidence Interval|Number
2653751|NCT01641809|Secondary|Number of Participants With Adherence to Study Treatment|Number of participants with >=90% adherence to study treatment based on pill count is summarized.|Baseline (Day 1), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312|ITT-E Population. Only participants who were dispensed and returned drug on scheduled visits were included in the analysis (represented by n=X in category titles)|||Participants|||Count of Participants
2653752|NCT01641809|Secondary|Number of Participants With Treatment Emergent Genotypic Mutations Associated With Development of Resistance|Plasma samples were collected for drug resistance testing. The treatment emergent INI mutations associated with development of resistance to RAL, ELV, dolutegravir (DTG) or GSK1265744 and major resistance mutations to other classes (NRTI, NNRTI, PI) as defined by International AIDS society (IAS)-United States of America (USA) are presented. On-treatment Genotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment genotypic resistance data, excluding participants who are not protocol-defined virologic failures.|Up to Week 324|On-treatment Genotypic resistance Population|||Participants|||Count of Participants
2653753|NCT01641809|Secondary|Number of Participants With Treatment Emergent Phenotypic Resistance|Plasma samples were collected for drug resistance testing. Phenotypic resistance data for the following drugs under integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), NRTI and proteasome inhibitor drug classes is presented for participants with confirmed virologic failure: GSK1265744, Raltegravir [RAL], Delavirdine [DLV], Efavirenz [EFV], Etravirine [ETR], Nevirapine (NVP), RPV, 3TC, ABC, FTC, TDF, Zidovudine [ZDV], Stavudine [d4T], Didanosine [ddI], Atazanavir/ritonavir [ATV/r], Darunavir (DRV)/r, Fosamprenavir/r [FPV/r], Indinavir/r [IDV/r], Lopinavir/r [LPV/r], Nelfinavir [NFV], Ritonavir [RTV], Saquinavir/r [SQV/r], Tipranavir/r [TPV/r]. On-treatment Phenotypic Resistance population comprised of all participants in the ITT-E Population with available on-treatment phenotypic resistance data, excluding participants who are not protocol-defined virologic failures.|Up to Week 324|On-treatment Phenotypic Resistance Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Participants|||Count of Participants
2653755|NCT01641809|Secondary|Absolute Values for Cluster of Differentiation 4+ (CD4+) Cell Count During Double-blind Randomized Treatment Until Week 96|CD4+ cell counts were assessed by flow cytometry. Baseline value is the last pre-treatment value observed.|Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96|ITT-E Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Cells per cubic millimeter||Standard Deviation|Mean
2653756|NCT01641809|Secondary|Number of Participants With Post-Baseline HIV-1 Associated Conditions Progression of Disease|HIV-1 associated conditions were assessed according to the 1993 Centers for Disease Control and Prevention (CDC) Revised Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death.|Up to Week 324|ITT-E Population|||Participants|||Count of Participants
2653757|NCT01641809|Secondary|Change From Baseline in Plasma log10 HIV-1 RNA Over Time by Visit|Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed. Change from Baseline is calculated as value at indicated time point minus Baseline value.|Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324|ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Log10 copies per milliliter||Standard Deviation|Mean
2653758|NCT01641809|Secondary|Absolute Values for Plasma Logarithm to the Base 10 (log10) HIV-1 RNA Over Time by Visit|Plasma samples for quantitative analysis of HIV-1 RNA were collected at indicated time points. Baseline value is the last pre-treatment value observed.|Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324|ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Log10 copies per milliliter||Standard Deviation|Mean
2653759|NCT01641809|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using Observed Case Analysis|Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period or open-label phase.|Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312 and 324|ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)|||Percentage of participants|||Number
2653760|NCT01641809|Secondary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL Over Time by Visit Using the MSDF Algorithm|Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.|Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300 and 312|ITT-E Population. Participants randomized to Efavirenz 600 mg arm were considered to have completed their participation in the study after Week 96; hence were no longer followed as part of this study.|||Percentage of participants|||Number
2653761|NCT01641809|Secondary|Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the Observed Case Analysis|Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the observed case analysis, which did not impute for any missing assessments. Observed case response rate was calculated as the number of participants with a positive response at the time point where the participant is on randomized therapy divided by the number of participants in the analysis population with an assessment in the scheduled visit window during the randomized period.|Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 20, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96|ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles)|||Percentage of participants|||Number
2653762|NCT01641809|Secondary|Percentage of Participants With Plasma HIV-1 RNA <400 Copies/mL Until Week 96 Using the MSDF Algorithm|Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with HIV-1 RNA <400 copies/mL over time was determined using the MSDF algorithm based on the current US FDA definition of the Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population.|Baseline (Day 1), Weeks 2, 4, 8, 12, 16, 24, 26, 28, 32, 36, 40, 48, 60, 72, 84 and 96|ITT-E Population|||Percentage of participants|||Number
2654016|NCT01640054|Secondary|HAQ-DI Score Over Time|HAQ-DI = health assessment questionnaire - disability index, n/a = not applicable, PO = orally, QD = once daily|Every 12 weeks for one year then every 24 weeks until study end|Insufficient data were available for analysis due to sparse data collection and the early termination of the study.||||||
2653763|NCT01641809|Primary|Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) <50 Copies/Milliliter (mL) at Week 48 Using the Missing, Switch, Discontinuation Equals Failure (MSDF) Algorithm|Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 was determined using the MSDF algorithm based on the current US Food and Drug Administration (FDA) definition of Snapshot algorithm. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to visit window) as well as participants who switch their concomitant antiretroviral therapy prior to the visit of interest as non-responders. Virological response within an analysis window was determined by the last available HIV-1 RNA measurement in that window while the participant was on-treatment. MSDF response rate was calculated as number of responders in the analysis window divided by the number of participants in the analysis population. ITT-E Population comprised of all randomized participants who received at least one dose of investigational product.|Week 48|ITT-E Population|||Percentage of participants||95% Confidence Interval|Number
2653764|NCT01641692|Secondary|Change From Baseline in the Mean Number of Puffs Per Day of Rescue Albuterol/Salbutamol Over Day 7 to Day 14 of Each Treatment Period|The mean number of puffs per day of rescue salbutamol at Baseline (i.e. run-in or washout data) and on-treatment were recorded. Total puffs was calculated as (Number of Puffs + (2 x number of Nebules)). Only the 7 days proceeding each treatment period were included in the Baseline calculations. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline (Day 7 prior to each treatment period) and the last 7 days of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Number of puffs||Standard Deviation|Mean
2653765|NCT01641692|Secondary|Change From Baseline in Mean Morning (AM) and Evening (PM) Pre-treatment Peak Expiratory Flow (PEF) Over Day 7 to Day 14 of Each Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants daily in the morning and evening just prior to each dose, using an electronic peak flow meter, throughout the 14-day Treatment Period. Only the averaged daily AM and PM PEF over Days 7 to 14 was analyzed. The analysis was performed using a mixed effects analysis of covariance model with fixed effect terms for treatment and period; Baseline PEF AM and PM, gender and age fitted as covariates; and participant as a random effect.|Baseline (Day 7 prior to each treatment period) and the last 7 days of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."|||Liters per minute||Standard Deviation|Mean
2653766|NCT01641692|Secondary|Change in Baseline in Serial FEV1 Over 0-24 Hours After the Morning Dose on Day 14 of Each Treatment Period|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry. Serial FEV1 was measured at 5, 15, 30 minutes (min), 1, 3, 6, 9, 12, 16, 20, 23 and 24 hours (h) post-dose. Baseline is the 0h value obtained prior to the AM dose on Day 14 of the treatment period. Change from Baseline was calculated as FEV1 value at the evaluated time point minus Baseline. Analysis was preformed using a repeated measures model with terms for period, treatment, time, mean Baseline, period Baseline, and time by mean Baseline, time by period Baseline, and time by treatment interactions.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."|||Liters||Standard Error|Least Squares Mean
2653767|NCT01641692|Secondary|Change From Baseline (BL) in the Weighted Mean (WM) 0-24 Hour FEV1 Obtained Post-AM Dose on Day 14 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. Baseline is the 0h value obtained prior to the AM dose on Day 14 of the treatment period. Change from BL at a was calculated as WM at the evaluated time point minus BL. Analysis was performed using a mixed model, including treatment, period, period Baseline FEV1, and mean Baseline FEV1 as fixed effects and participant as a random effect.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2653768|NCT01641692|Primary|Number of Participants With the Indicated 24 Hour Holter Findings|Twenty-four hour Holter ECG measurements were obtained using a 12-lead Holter monitor. The Holter monitor is worn by the participant for 24 hours, and the monitor continuously records the heart's rhythm while the monitor is worn. Following the 24-hour period, the data from the monitor were downloaded and transmitted to the centralized vendor for analysis and interpretation by a licensed cardiologist. The 24-hour Holter ECG measurements were obtained at during the screening period and on Day 14 of each treatment period. The number of participants with clinically significant change (abnormal or normal) were reported.|Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only participants with sufficient data (at least 16 hours of recorded data) at the specified time points were analyzed.|||Participants|||Number
2653769|NCT01641692|Primary|Number of Participants With the Indicated Abnormal Electrocardiogram Findings|Electrocardiograph measurements performed at Screening (Visit 1) and at Day 1 and Day 14 (pre-dose, 10 minutes post-dose and 2 hours post-dose.of each treatment period). Any clinically significant findings were identified during participant monitoring.|Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed.|||Participants|||Number
2653770|NCT01641692|Primary|Urine Specific Gravity on Day 14 of Each Treatment Period|Urine samples were collected for the measurement of urine specific gravity by dipstick method at Day 14. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. A urinary specific gravity measurement is a routine part of urinalysis. The reference range is 1.002-1.030.|Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2653772|NCT01641692|Primary|Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick on Day 14 of Each Treatment Period|Urinalysis parameters included: Urine Bilirubin (UB), Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Nitrite (UN), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace (T), 1+, 2+, and 3+, and for UG the result can be read as Neg, T, T or 1/10 G/dL, 1+ or 1/4 G/dL, 3+ or 1 G/dL, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, T, 1+, 2+ and 3+ levels at Day 14.|Baseline and Day 14 of each treatment period (up to Study Day 70))|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."|||Participants|||Number
2653773|NCT01641692|Primary|Change From Baseline in Hematocrit on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of hematocrit (proportion of red blood cells in blood) at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Proportion of red blood cells in blood||Standard Deviation|Mean
2653774|NCT01641692|Primary|Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils (neut) at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."|||Percentage of cells in blood||Standard Deviation|Mean
2653775|NCT01641692|Primary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (ANC - Absolute Neutrophil Count), Platelet, and Leukocytes Count on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils (ANC - Absolute neutrophil [neut] count), platelet, and leucocytes count at Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."|||10^9 cells/Liter (GI/L)||Standard Deviation|Mean
2653776|NCT01641692|Primary|Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of chloride, caron dioxide, glucose, potassium, sodium, and urea/BUN at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."|||Micromoles/Liter (µM/L)||Standard Deviation|Mean
2653777|NCT01641692|Primary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of direct bilirubin, indirect (ind) bilirubin, total bilirubin, and creatinine at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."|||Micromoles/Liter (µM/L)||Standard Deviation|Mean
2653778|NCT01641692|Primary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LDH) on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of ALP, ALT, AST, CK, GGT, and LDH at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."|||International Units/Liter (IU/L)||Standard Deviation|Mean
2653779|NCT01641692|Primary|Change From Baseline in Albumin, Total Protein, and Hemoglobin on Day 14 of Each Treatment Period|Blood samples were collected for the measurement of albumin, total protein, and hemoglobin at Baseline and Day 14. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70))|"ITT Population. Only those participants remaining in the study and contributing evaluable data for the indicated parameter were indicated by n=X, X in the category title and the overall number of participants analyzed reflects everyone in the ITT Population."|||Grams per liter (G/L)||Standard Deviation|Mean
2653780|NCT01641692|Primary|Change From Baseline in Pulse Rate on Day 14 of Each Treatment Period|Pulse rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Analysis was performed using a mixed model, including treatment, period, period Baseline and mean Baseline for the measure as fixed effects and participant as a random effect. Baseline is the value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline was calculated as the assessment value at Day 14 minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Beats per minute||Standard Error|Least Squares Mean
2653781|NCT01641692|Primary|Change From Baseline in Diastolic Blood Pressure on Day 14 of Each Treatment Period|Blood pressure measurement included diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Analysis was performed using a mixed model, including treatment, period, period Baseline and mean Baseline for the measure as fixed effects and participant as a random effect. Baseline is the value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline was calculated as the assessment value at Day 14 minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2653782|NCT01641692|Primary|Change From Baseline in Systolic Blood Pressure on Day 14 of Each Treatment Period|Blood pressure measurement included systolic blood pressure (SBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Analysis was performed using a mixed model, including treatment, period, period Baseline and mean Baseline for the measure as fixed effects and participant as a random effect. Baseline is the value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline was calculated as the assessment value at Day 14 minus the Baseline value.|Baseline and Day 14 of each treatment period (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2653783|NCT01641692|Primary|Number of Participants With Asthma Exacerbations During the Treatment Period|Worsening of asthma symptoms is monitored throughout the study. Severe exacerbation (deterioration of asthma requiring use of systemic corticosteroids for 3 days, inpatient hospitalization or emergency department visit due to asthma) is an exclusion criterion and requires withdrawal from the study. Asthma symptoms were assessed daily using an electronic diary throughout study.|From Baseline until the end of Treatment Period 3 (up to Study Day 70)|ITT Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Number
2653784|NCT01641692|Primary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of SAEs.|From Baseline until the end of Treatment Period 3 (up to Study Day 70)|ITT Population|||Participants|||Number
2653785|NCT01641692|Primary|Change From Baseline in Trough FEV1 on Day 15 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 15 is defined as the value obtained 24 hours after the morning dose administered on Day 14. Analysis was performed using a mixed model, including treatment, period, period Baseline FEV1 and mean Baseline FEV1 as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the trough FEV1 at Day 15 minus the Baseline value for that treatment period.|Day 15 of each treatment period (up to Study Day 71)|ITT Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 15.|||Liters||Standard Error|Least Squares Mean
2653786|NCT01641692|Primary|Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1)|Dose-response was conducted for both QD and BID UMEC doses on trough FEV1 (measure of lung function, defined as the maximal amount of air that can be forcefully exhaled in 1 second) on D 15. Total daily dose of UMEC was used in the modeling. The null model was the final model. The null model is defined as: CFEV1,ij=(THETA1+ETA1j)*meanBL+(THETA2+ETA1j)*periodBL+EPSij, where CFEV1,ij represents the change from BL in trough FEV1 for participant j measured at period i. THETA1 and THETA2 were the slopes with respect to meanBL and periodBL, respectively. Omegas were the variance of the slopes on meanBL and periodBL (ETA1j, ETA2j) for each participant and Sigma was the variance of the residual errors (EPSij). MeanBL is the mean of the Baseline (BL) which is the FEV1 value recorded pre-dose on D 1 of each TP; periodBL is the difference between the BL and the meanBL in each TP for each participant.|Day 15 of each treatment period (up to Study Day 71)|Intent-To-Treat (ITT) Population: : all participants randomized to treatment and who received at least one dose of study medication. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 15.|||unitless||95% Confidence Interval|Geometric Mean
2653787|NCT01641653|Secondary|Percent Intra-op Blood Glucose Level of 140mg/dL or Less|blood glucose level will be tested perioperatively at 30 minute intervals following induction. All glucose levels will be recorded .midazolam group will maintain a blood glucose level perioperatively of 140mg/dL or less|perioperatively||||percentage of glucose levels<140|||Number
2653788|NCT01641653|Secondary|Glucose Level Percent Change From Pre-op to Maximum Glucose Level|blood glucose level measured preoperatively, through surgical period and in PACU at 30 min and 60 min|Preoperatively, intraoperatively 30 min for duration of surgery|per protocol|||percentage of increase in glucose level||Inter-Quartile Range|Median
2653789|NCT01641653|Primary|Maximum Perioperative Blood Glucose Level of 30 Minute Interval Measurements|Non diabetic subjects undergoing hernia repair were randomized into 2 groups. Midazolam vs. placebo. Blood glucose level was monitored preoperatively and following induction of anesthesia at 30 minute intervals perioperatively, and after in the PACU at 30 minutes and 60 minutes following arrival. All readings were performed using the Abbott Freestyle Glucose Monitor.|every 30 min for duration of surgery|per protocol|||mg/dL||Inter-Quartile Range|Median
2653794|NCT01641640|Primary|Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug|The number of participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments.|Baseline to Week 12|Safety Analysis Set|||participants|||Number
2653795|NCT01641640|Primary|Percentage of Participants Achieving Sustained Virologic Response (SVR)12|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy.|Posttreatment Week 12|Full Analysis Set|||percentage of participants|||Number
2653796|NCT01641471|Secondary|General Health Outcome - SF-12 Physical Component Summary|Physical Component Score. Physical Component Score (PCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. PCS provides emphasis on questions about general health, physical functioning and role playing and bodily pain. PCS is standardized using a z-score transformation and normed to a US population (Based on a 1990 norm) of a score of 50.0 and a standard deviation of 10.0. Normalized scores reported.|6 weeks (+/- 3 days) postoperative||||z-scale||Standard Deviation|Mean
2653797|NCT01641471|Secondary|Functional Assessments|Timed up and go (TUG) test. These methods follows those published by Podsiadlo and Richardson, JAGS 1991; 39:142-148, in which the patient is observed and timed while he/she rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.|6 weeks (+/- 3 days) postoperative||||seconds||Standard Deviation|Mean
2653798|NCT01641471|Secondary|Visual Analog Pain Score (VAS)|Pain VAS is a continuous scale comprised of a vertical line, 10 centimeters in length, with each centimeter marked by its' corresponding whole number (1, 2, 3, etc.). It ranges from 0 to 10, with 0 being no pain and 10 being maximum pain.|6 weeks (+/- 3 days) postoperative||||units on a scale||Standard Deviation|Mean
2653799|NCT01641471|Primary|Narcotic Usage|Morphine Equivalent dose, mg/kg|Through 6 weeks after surgery||||morphine equivalents||Standard Deviation|Mean
2653800|NCT01641380|Other Pre-specified|Acceptability|To determine acceptability we measured the number of individuals who were eligible for the trial and the number of eligible individuals who agreed to participate in the trial.|Baseline Recruitment|Number of eligible participants among those approached|||participants|||Number
2653801|NCT01641380|Secondary|Patient Satisfaction|% of patients indicating satisfaction with the messaging reminder/health information service|9 months|Participants in the control group did not receive text messages (intervention) and so no data was collected for them.|||participants|||Number
2653802|NCT01641380|Primary|Responsiveness to Appointment Messages|Overall responsiveness to delivery confirmation requests with A) Appointment messages and B) Informational Messages|9 months|Participants in the control group did not receive text messages (intervention) and so no data was collected for them.|||participants|||Number
2653803|NCT01641380|Primary|Appointment Adherence (Efficacy)|Participants who returned on-time for appointments|9 months|Evaluated differences in percentage of participants who return for on-time DepoProvera appointments for first cycle|||participants|||Number
2653804|NCT01641367|Secondary|Change From Baseline in Fasting Values of Glucose [CPI+SOC v SOC]|Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen.|Baseline, week 24, 48, and 72|All participants randomized to either CPI+SOC or SOC with results available at baseline and at the given follow-up time point|||mg/dL||Standard Deviation|Mean
2653805|NCT01641367|Secondary|Change From Baseline in Fasting Values of Triglycerides [CPI+SOC v SOC]|Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen.|Baseline, week 24, 48, and 72|All participants randomized to either CPI+SOC or SOC with results available at baseline and at the given follow-up time point|||mg/dL||Standard Deviation|Mean
2653806|NCT01641367|Secondary|Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol [CPI+SOC v SOC]|Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen.|Baseline, week 24, 48, and 72|All participants randomized to either CPI+SOC or SOC with results available at baseline and at the given follow-up time point|||mg/dL||Standard Deviation|Mean
2653807|NCT01641367|Secondary|Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol [CPI+SOC v SOC]|Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen.|Baseline, week 24, 48, and 72|All participants randomized to either CPI+SOC or SOC with results available at baseline and at the given follow-up time point|||mg/dL||Standard Deviation|Mean
2653808|NCT01641367|Secondary|Change From Baseline in Fasting Values of Total Cholesterol [CPI+SOC v SOC]|Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen.|Baseline, week 24, 48, and 72|All participants randomized to either CPI+SOC or SOC with results available at baseline and at the given follow-up time point|||mg/dL||Standard Deviation|Mean
2653809|NCT01641367|Secondary|Change From Baseline in CD4+ T-cell Count [CPI+SOC v SOC]|Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen.|Baseline, week 24, 48, and 72|All participants randomized to either CPI+SOC or SOC with results available at baseline and at the given follow-up time point|||cells/mm^3||Standard Deviation|Mean
2654017|NCT01640054|Secondary|DAS28-CRP Score Over Time|CRP = C-reactive protein, DAS28 = disease activity score based on a 28 joint count, n/a = not applicable, PO = orally, QD = once daily|Every 12 weeks for one year then every 24 weeks until study end|Insufficient data were available for analysis due to sparse data collection and the early termination of the study.||||||
2653810|NCT01641367|Secondary|Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48 [CPI+SOC v SOC]|Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used.|From study entry to Week 48|All participants randomized to either CPI+SOC or SOC|||percentage of participants||95% Confidence Interval|Number
2653811|NCT01641367|Secondary|Time to First Dose Modification Due to Grade 3 or 4 Toxicity [CPI+SOC v SOC]|Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used.|From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|All participants randomized to either CPI+SOC or SOC|||weeks||95% Confidence Interval|Number
2653812|NCT01641367|Secondary|Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48 [CPI+SOC v SOC]|Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit.|From study entry to Week 48|All participants randomized to either CPI+SOC or SOC|||percentage of participants||95% Confidence Interval|Number
2653813|NCT01641367|Secondary|Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS) [CPI+SOC v SOC]|Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit.|From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|All participants randomized to either CPI+SOC or SOC|||weeks||95% Confidence Interval|Number
2653814|NCT01641367|Secondary|Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48 [CPI+SOC v SOC]|Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used.|From study entry to Week 48|All participants randomized to either CPI+SOC or SOC|||percentage of participants||95% Confidence Interval|Number
2653815|NCT01641367|Secondary|Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity [CPI+SOC v SOC]|Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used.|From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|All participants randomized to either CPI+SOC or SOC|||weeks||95% Confidence Interval|Number
2653816|NCT01641367|Secondary|Percent of Participants With Treatment Modification or Discontinuation by Week 48 [CPI+SOC v SOC]|Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit.|From study entry to Week 48|All participants randomized to either CPI+SOC or SOC|||percentage of participants||95% Confidence Interval|Number
2653817|NCT01641367|Secondary|Time From Study Entry/Randomization to Treatment Modification or Discontinuation [CPI+SOC v SOC]|Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit.|From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|All participants randomized to either CPI+SOC or SOC|||weeks||95% Confidence Interval|Number
2653818|NCT01641367|Secondary|Percent of Participants With Death or Hospitalization by Week 48 [CPI+SOC v SOC]|Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis.|From study entry to Week 48|All participants randomized to either CPI+SOC or SOC|||percentage of participants||95% Confidence Interval|Number
2653819|NCT01641367|Secondary|Time From Study Entry/Randomization to the First of Death or Hospitalization [CPI+SOC v SOC]|Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis.|From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|All participants randomized to either CPI+SOC or SOC|||weeks||95% Confidence Interval|Number
2653837|NCT01641367|Secondary|Change From Baseline in Fasting Values of High-density Lipoprotein Cholesterol|Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)]|Baseline, week 24, 48 and 72|all enrolled participants with results available at baseline and at the given follow-up time point|||mg/dL||Standard Deviation|Mean
2653820|NCT01641367|Secondary|Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48 [CPI+SOC v SOC]|Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events.|From study entry to Week 48|All participants randomized to either CPI+SOC or SOC|||percentage of participants||95% Confidence Interval|Number
2653821|NCT01641367|Secondary|Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event [CPI+SOC v SOC]|Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events.|From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|All participants randomized to either CPI+SOC or SOC|||weeks||95% Confidence Interval|Number
2653822|NCT01641367|Secondary|Percent of Participants Experiencing Death by Week 48 [CPI+SOC v SOC]|Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit.|From study entry to Week 48|All participants randomized to either CPI+SOC or SOC|||percentage of participants||95% Confidence Interval|Number
2653823|NCT01641367|Secondary|Time From Study Entry/Randomization to Death [CPI+SOC v SOC]|Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit.|From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|All participants randomized to either CPI+SOC or SOC|||weeks||95% Confidence Interval|Number
2653824|NCT01641367|Secondary|Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48 [CPI+SOC v SOC]|Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.Event times were the scheduled week of the initial failing measurement(RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after).Censoring times were the scheduled week of the last RNA result.A new resistance-associated mutation is defined as one not present in the genotype prior to entry.|From week 24 to Week 48|All participants randomized to either CPI+SOC or SOC|||percentage of participants||95% Confidence Interval|Number
2653825|NCT01641367|Secondary|Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]|Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. A new resistance-associated mutation is defined as one not present in the genotype prior to entry.|From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|All participants randomized to either CPI+SOC or SOC|||Participants|||Count of Participants
2653826|NCT01641367|Secondary|Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing [CPI+SOC v SOC]|Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. A new resistance-associated mutation is defined as one not present in the genotype prior to entry.|From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|All participants randomized to either CPI+SOC or SOC|||weeks||95% Confidence Interval|Number
2653827|NCT01641367|Secondary|Percent of Participants With Confirmed Virologic Failure by Week 48 [CPI+SOC v SOC]|Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result.|From week 24 to Week 48|All participants randomized to either CPI+SOC or SOC|||percentage of participants||95% Confidence Interval|Number
2653828|NCT01641367|Secondary|Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]|Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.|From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|All participants randomized to either CPI+SOC or SOC|||Participants|||Count of Participants
2653829|NCT01641367|Secondary|Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study [CPI+SOC v SOC]|Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result.|From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|All participants randomized to either CPI+SOC or SOC|||weeks||95% Confidence Interval|Number
2653830|NCT01641367|Secondary|Number of Weeks of Follow-up [CPI+SOC v SOC]|All participants were followed on step 1/2 until 48 weeks after the last participant was enrolled to step 1 regardless of virologic status or treatment switches.|From study entry through Step 1/2 follow-up|All participants randomized to either CPI+SOC or SOC|||weeks||Inter-Quartile Range|Median
2653831|NCT01641367|Secondary|Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks [CPI+SOC v SOC]|"The measurement closest to exactly 72 weeks (ie, 7x72=504 days) after the date of entry, within the window of 72 weeks ± 6 weeks (specifically 463 to 546 days, inclusive).~The analysis in the protocol and in the Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 72 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 72 was considered as HIV-1 RNA>200 copies/mL at week 72. If a result was expected, missing results at week 72 were considered as HIV-1 RNA >200 copies/mL at week 72 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL."|72 weeks after the date of entry|All participants randomized to either CPI+SOC or SOC with results expected at week 72|||proportion of participants||95% Confidence Interval|Number
2653832|NCT01641367|Secondary|Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks [CPI+SOC v SOC]|"The measurement closest to exactly 24 weeks (ie, 7x24=168 days) after the date of entry, within the window of 24 weeks ± 6 weeks (specifically 127 to 210 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 24 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 24 was considered as HIV-1 RNA>200 copies/mL at week 24. Missing results at week 24 were considered as HIV-1 RNA >200 copies/mL at week 24 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL."|24 weeks after the date of entry|All participants randomized to either CPI+SOC or SOC|||proportion of participants||95% Confidence Interval|Number
2653833|NCT01641367|Secondary|Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks [CPI+SOC v SOC]|"The measurement closest to exactly 48 weeks (ie, 7x48=336 days) after the date of entry, within the window of 48 weeks ± 6 weeks (specifically 295 to 378 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 48 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 48 was considered as HIV-1 RNA>200 copies/mL at week 48. Missing results at week 48 were considered as HIV-1 RNA >200 copies/mL at week 48 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL."|48 weeks after the date of entry|All participants randomized to either CPI+SOC or SOC|||proportion of participants||95% Confidence Interval|Number
2653834|NCT01641367|Secondary|Change From Baseline in Fasting Values of Glucose|Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)|Baseline, week 24, 48 and 72|all enrolled participants with results available at baseline and at the given follow-up time point|||mg/dL||Standard Deviation|Mean
2653835|NCT01641367|Secondary|Change From Baseline in Fasting Values of Triglycerides|Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)|Baseline, week 24, 48 and 72|all enrolled participants with results available at baseline and at the given follow-up time point|||mg/dL||Standard Deviation|Mean
2653836|NCT01641367|Secondary|Change From Baseline in Fasting Values of Calculated Low-density Lipoprotein Cholesterol|Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)|Baseline, week 24, 48 and 72|all enrolled participants with results available at baseline and at the given follow-up time point|||mg/dL||Standard Deviation|Mean
2654018|NCT01640054|Secondary|Components of ACR Response Criteria Over Time|ACR = American College of Rheumatology, n/a = not applicable, PO = orally, QD = once daily|Every 12 weeks for one year then every 24 weeks until study end|Insufficient data were available for analysis due to sparse data collection and the early termination of the study.||||||
2653838|NCT01641367|Secondary|Change From Baseline in Fasting Values of Total Cholesterol|Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)|Baseline, week 24, 48 and 72|all enrolled participants with results available at baseline and at the given follow-up time point|||mg/dL||Standard Deviation|Mean
2653839|NCT01641367|Secondary|Change From Baseline in CD4+ T-cell Count|Baseline is defined as the last measurement obtained on or before the earlier of the following two dates: the date of entry/randomization plus three days (this is the time allowed in the protocol for starting study-defined ART) and the date of starting the study-defined ARV regimen (this second date applies only to Cohorts B, C and D as there is no change of regimen for patients in Cohort A)|Baseline, week 24, 48, and 72|all enrolled participants with results available at baseline and at the given follow-up time point|||cells/mm^3||Standard Deviation|Mean
2653840|NCT01641367|Secondary|Percent of Participants With a Dose Modification Due to Grade 3 or 4 Toxicity by Week 48|Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used.|From study entry to week 48|all enrolled participants|||percentage of participants||95% Confidence Interval|Number
2653841|NCT01641367|Secondary|Time to First Dose Modification Due to Grade 3 or 4 Toxicity|Event time was the exact week of the modification. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. DAIDS AE Grading Table, Version 1.0 was used.|From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|all enrolled participants|||weeks||95% Confidence Interval|Number
2653842|NCT01641367|Secondary|Percent of Participants That Developed Immune Reconstitution Inflammatory Syndrome (IRIS) by Week 48|Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit.|From study entry to week 48|all enrolled participants|||percentage of participants||95% Confidence Interval|Number
2653843|NCT01641367|Secondary|Time From Study Entry/Randomization to the Development of Immune Reconstitution Inflammatory Syndrome (IRIS)|Event time was the exact week of the diagnosis. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort.|From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|all enrolled participants|||weeks||95% Confidence Interval|Number
2653844|NCT01641367|Secondary|Percent of Participants With Treatment Modification or Discontinuation Due to Toxicity by Week 48|Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. DAIDS AE Grading Table, Version 1.0 was used.|From study entry to Week 48|all enrolled participants|||percentage of participants||95% Confidence Interval|Number
2653845|NCT01641367|Secondary|Time From Study Entry/Randomization to Treatment Modification or Discontinuation Due to Toxicity|Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen, due to an adverse event. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort. DAIDS AE Grading Table, Version 1.0 was used.|From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|all enrolled participants|||weeks||95% Confidence Interval|Number
2653846|NCT01641367|Secondary|Percent of Participants With Treatment Modification or Discontinuation by Week 48|Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earliest time point between last dose week and the week of the last step 1/2 visit.|From study entry to Week 48|all enrolled participants|||percentage of participants||95% Confidence Interval|Number
2653847|NCT01641367|Secondary|Time From Study Entry/Randomization to Treatment Modification or Discontinuation.|Treatment modification is defined as the first occurrence of a substitution or subtraction of one or more drugs in the study regimen, a temporary hold lasting 7 days or longer, or the addition of a new drug to the regimen. This would not include splitting any fixed dose combination medications if the participant continues on the active drugs of the combination. Event time was the exact week of the modification or discontinuation. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort.|From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|all enrolled participants|||weeks||95% Confidence Interval|Number
2653848|NCT01641367|Secondary|Percent of Participants With Death or Hospitalization by Week 48|Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis.|From study entry to Week 48|all enrolled participants|||percentage of participants||95% Confidence Interval|Number
2654036|NCT01639729|Primary|AUC (0 - Inf)|total amount of sufentanil absorbed|24 hours|A The number of subjects (n) in Treatment D was less than the total 22 subjects for the following PK parameters: AUC 0-inf (n=18).|||h.pg/mL||Standard Deviation|Mean
2653849|NCT01641367|Secondary|Time From Study Entry/Randomization to the First of Death or Hospitalization.|Event time was the exact week of death or hospitalization. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. If a participant experienced multiple events, then the time of the first event was used in the analysis. Length of follow-up varied by Cohort.|From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|all enrolled participants|||weeks||95% Confidence Interval|Number
2653850|NCT01641367|Secondary|Percent of Participants Experiencing Death, AIDS-defining Event or a Non-AIDS-defining Event by Week 48|Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events.|From study entry to Week 48|all enrolled participants|||percentage of participants||95% Confidence Interval|Number
2653851|NCT01641367|Secondary|Time From Study Entry/Randomization to the First of Death, an AIDS-defining Event or a Non-AIDS-defining Event|Event time was the exact week of death, AIDS-defining event or non-AIDS defining event. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Only new events were considered, an event that was also reported at or prior to study entry was not included. If a participant experienced multiple events, then the time of the first event was used in the analysis. AIDS defining events included parasitic, fungal, bacterial, and viral infections as well as neoplastic diseases, and neurological disorders. Non-AIDS defining events included malignancies, diabetes, neuropathies, cardiac and renal events. Length of follow-up varied by Cohort.|From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|all enrolled participants|||weeks||95% Confidence Interval|Number
2653852|NCT01641367|Secondary|Percent of Participants Experiencing Death by Week 48|Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit.|From study entry to Week 48|all enrolled participants|||percentage of participants||95% Confidence Interval|Number
2653853|NCT01641367|Secondary|Time From Study Entry/Randomization to Death|Event time was the exact week of death. Censoring time was the earlier of last contact week and the week of the last step 1/2 visit. Length of follow-up varied by Cohort.|From study entry through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|all enrolled participants|||weeks||95% Confidence Interval|Number
2653854|NCT01641367|Secondary|Percent of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing, by Week 48|Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure.Event times were the scheduled week of the initial failing measurement(RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after).Censoring times were the scheduled week of the last RNA result.Length of follow-up varied by Cohort.A new resistance-associated mutation is defined as one not present in the genotype prior to entry.|From week 24 to Week 48|All enrolled participants|||percentage of participants||95% Confidence Interval|Number
2653855|NCT01641367|Secondary|Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing|Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure[specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit).HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Length of follow-up varied by Cohort. A new resistance-associated mutation is defined as one not present in the genotype prior to entry.|From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|All enrolled participants|||Participants|||Count of Participants
2653856|NCT01641367|Secondary|Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study, With a New Resistance-associated Mutation Detected in Population-based Sequencing|Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort. A new resistance-associated mutation is defined as one not present in the genotype prior to entry.|From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|All enrolled participants|||weeks||95% Confidence Interval|Number
2653904|NCT01641042|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values|The cut-off value for the assay was ≥ 1:4.|Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
2653857|NCT01641367|Secondary|Percent of Participants With Confirmed Virologic Failure by Week 48|Results report percent of participants reaching outcome by week 48 using Kaplan-Meier method. Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry(to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement,allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort.|From week 24 to Week 48|All enrolled participants|||percentage of participants||95% Confidence Interval|Number
2653858|NCT01641367|Secondary|Number of Participants With Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study|Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Length of follow-up varied by Cohort.|From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|All enrolled participants|||Participants|||Count of Participants
2653859|NCT01641367|Secondary|Time to Confirmed Virologic Failure, Defined as First HIV-1 RNA ≥1000 Copies/mL at or After 24 Weeks on Study|Virologic failure was confirmed by the next HIV-1 RNA measurement ≥1000 copies/mL (irrespective of time between initial and confirmatory measure [specimens on separate dates] and treatment status). A week 24 measurement included HIV-1 RNA obtained ≥7*22=154 days after study entry (to allow for 14 day window for scheduling the visit). HIV-1 RNA measurements through and including 21 November 2016 were considered in identifying an initial failing measurement, allowing HIV-1 RNA at the close-out visit between 22 November 2016 and 13 February 2017 to be a confirmatory measure. Event times were the scheduled week of the initial failing measurement (RNA scheduled at week 0, 12, 24, 48 and every 24 weeks after). Censoring times were the scheduled week of the last RNA result. Length of follow-up varied by Cohort.|From week 24 through Step 1/2 follow-up; median (IQR) step 1/2 follow-up was 72 (72,108) weeks|All enrolled participants|||weeks||95% Confidence Interval|Number
2653860|NCT01641367|Secondary|Number of Weeks of Follow-up|All participants were followed on step 1/2 until 48 weeks after the last participant was enrolled to step 1 regardless of virologic status or treatment switches. Length of follow-up varied by Cohort.|From study entry through Step 1/2 follow-up|all enrolled participants|||weeks||Inter-Quartile Range|Median
2653861|NCT01641367|Secondary|Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 72 Weeks|"The measurement closest to exactly 72 weeks (ie, 7x72=504 days) after the date of entry, within the window of 72 weeks ± 6 weeks (specifically 463 to 546 days, inclusive).~The analysis in the protocol and in the Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 72 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 72 was considered as HIV-1 RNA>200 copies/mL at week 72. If a result was expected, missing results at week 72 were considered as HIV-1 RNA >200 copies/mL at week 72 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 72. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided."|72 weeks after the date of entry|All participants with results expected at week 72|||proportion of participants||95% Confidence Interval|Number
2653862|NCT01641367|Secondary|Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 24 Weeks|"The measurement closest to exactly 24 weeks (ie, 7x24=168 days) after the date of entry, within the window of 24 weeks ± 6 weeks (specifically 127 to 210 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 24 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 24 was considered as HIV-1 RNA>200 copies/mL at week 24. Missing results at week 24 were considered as HIV-1 RNA >200 copies/mL at week 24 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 24. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided."|24 weeks after the date of entry|All enrolled participants|||proportion of participants||95% Confidence Interval|Number
2653863|NCT01641367|Primary|Proportion of Participants With Plasma HIV-1 RNA ≤200 Copies/mL at 48 Weeks|"The measurement closest to exactly 48 weeks (ie, 7x48=336 days) after the date of entry, within the window of 48 weeks ± 6 weeks (specifically 295 to 378 days after randomization, inclusive).~The analysis in the protocol and in the Stat. Analysis Plan involved estimating the proportion of participants in the overall study population with HIV-1 RNA ≤200 copies/mL at week 48 with a 95% confidence interval calculated via a Wald approach. Death or lost to follow-up before week 48 was considered as HIV-1 RNA>200 copies/mL at week 48. Missing results at week 48 were considered as HIV-1 RNA >200 copies/mL at week 48 unless the immediately preceding and succeeding HIV-1 RNA measurements were ≤200 copies/mL. Since the primary analysis was on the total study population, overall results were also submitted. All participants in B3 had HIV-1 RNA ≤200 copies/mL at week 48. Therefore, Wald confidence interval could not be computed for B3 and Clopper-Pearson Exact confidence interval is provided."|48 weeks after the date of entry|All enrolled participants|||proportion of participants||95% Confidence Interval|Number
2653933|NCT01640925|Secondary|ICU Length of Stay in Days|Number of days in the ICU after enrollment in study until first ICU discharge.|up to 28 days||||days||Standard Deviation|Mean
2653934|NCT01640925|Secondary|Incidence of Skin Irritation|The incidence of new onset skin irritation will be recorded and graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03.|up to 28 days||||Participants|||Count of Participants
2653864|NCT01641237|Secondary|Enamel Fluoride Uptake (Corrected Data)|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of fluoride divided by area of the enamel cores. Data analysis was based on corrected data.|Baseline to 4 hours|PP population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed. Data analysis for this outcome measure was performed based on a correction factor.|||micrograms*F/centimeters^2||Standard Error|Mean
2653865|NCT01641237|Secondary|Percentage Relative Erosion Resistance|Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine relative erosion resistance which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent relative erosion resistance was calculated by formula: [(E1-E2)/ (E1-B)]*100.|Baseline to 4 hours|PP population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed.|||% Relative Erosion Resistance||Standard Error|Mean
2653866|NCT01641237|Secondary|%SMHR|SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline to 4 hours|PP population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed.|||%SMHR||Standard Error|Mean
2653867|NCT01641237|Primary|Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship|SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.|Baseline to 4 hours|Per protocol population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing values were not imputed.|||%SMHR||Standard Error|Mean
2653868|NCT01641198|Primary|Comparison of Quantitative Bone Healing|Distance between first bone-to-implant contact point (fBIC) and microgap (MG) placed at the crest is measured at the right and left sides of each implant-abutment complex on periapical radiographs taken of each implant. Measurements were taken and recorded at 15 to 20 years of function. Mean fBIC-MG values were calculated, recorded and compared between B and SW, between B and SC and between SW and SC for Configuration 1, Configuration 2 and Configuration 3|At 15-20 years of function|Reasons for decrease in the number of participants: 7 did not respect follow up interval, 2 unrelated deaths|||mm|implants|Standard Error|Mean
2653869|NCT01641198|Primary|Comparison of Quantitative Bone Healing|Distance between first bone-to-implant contact point (fBIC) and microgap (MG) placed at the crest is measured at the right and left sides of each implant-abutment complex on periapical radiographs taken of each implant. Measurements were taken and recorded after 24 months of function. Mean fBIC-MG values were calculated, recorded and compared between B and SW, between B and SC and between SW and SC for Configuration 1, Configuration 2 and Configuration 3|After 24 months of function|Reasons for decrease in the number of participants: 19 did not respect follow up interval. Reasons for decrease in number of units (implants): radiographs did not allow precise location of first bone-to-implant contact point (fBIC) and microgap (MG) due to technical reasons for 5 implants|||mm|implants|Standard Error|Mean
2653870|NCT01641198|Primary|Comparison of Quantitative Bone Healing|Distance between first bone-to-implant contact point (fBIC) and microgap (MG) placed at the crest was measured at the right and left sides of each implant-abutment complex on periapical radiographs taken of each implant. Measurements were taken and recorded after 12 months of function. Mean fBIC-MG values were calculated, recorded and compared between B and SW, between B and SC and between SW and SC for Configuration 1, Configuration 2 and Configuration 3|After 12 months of function|Reasons for decrease in population number: 7 did non-respect interval follow up protocol, 1 adverse event, 1 protocol violation. Reasons for decrease in number of units (implants): radiographs did not allow precise location of first bone-to-implant contact point (fBIC) and microgap (MG) due to technical reasons for 19 implants|||mm|Implants.|Standard Error|Mean
2653871|NCT01641159|Secondary|Cocaine-use Days|Cocaine use days during days 22-105 as assessed by UDS and self-report combined with no imputation|study week 16|All randomized participants|||proportion of cocaine use days|||Number
2653872|NCT01641159|Primary|Maximum Days of Continuous Cocaine Abstinence|The primary outcome measure selected for the present two-stage protocol is the maximum days of continuous cocaine abstinence during study weeks 4-15. The Timeline Follow-back (TLFB) procedure (Sobell and Sobell, 1992; Fals-Stewart, 2000) will be used to assess the participants' self-reported use of substances for each day of the study. A rapid UDS system that screens for drugs of abuse will be used to analyze the urine samples.|study week 16||||Days||Standard Deviation|Mean
2653882|NCT01641133|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period|"Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity."|During the 4-day (Days 0-3) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in.|||Participants|||Count of Participants
2657194|NCT01607853|Secondary|Change From Baseline in Erythema at Day 18|Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 18||||units on a scale||Standard Deviation|Mean
2653873|NCT01641133|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes|The immunogenicity assessment was based on multiplex opsonophagocytic activity assay (MOPA). Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a serotype specific titer for opsonophagocytic activity higher than or equal to (≥) the Lower Limit of Quantification (LLOQ) i.e.: 14 for OPA-1, 11 for OPA-3; 40 for OPA-4; 15 for OPA-5; 45 for OPA-6A; 29 for OPA-6B; 28 for OPA-7F; 39 for OPA-9V; 16 for OPA-14; 40 for OPA-18C; 13 for OPA-19A; 33 for OPA-19F and 40 for OPA-23F.|At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)|The analysis was performed on the ATP cohort for immunogenicity adapted for each epoch, which included all evaluable subjects for whom data concerning primary or booster immunogenicity outcome measures were available. OPA testing was performed on a random subset of 50% per group.|||Titers||95% Confidence Interval|Geometric Mean
2653874|NCT01641133|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD)|Anti-PD antibody concentrations were measured by Enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL.|At study Month 3 (one month after primary vaccination) and at study Month 11 (one month after booster vaccination)|The analysis was performed on the ATP cohort for immunogenicity adapted for each epoch, which included all evaluable subjects for whom data concerning primary or booster immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2653875|NCT01641133|Secondary|Antibody Concentrations Against Pneumococcal Serotypes|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.|At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination)|The analysis was performed on the ATP cohort for immunogenicity adapted for each epoch, which included all evaluable subjects for whom data concerning primary or booster immunogenicity outcome measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2653876|NCT01641133|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From first vaccination (Month 0) up to study end (11-14 months)|The analysis was performed on the Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented.|||Participants|||Count of Participants
2653877|NCT01641133|Secondary|Number of Subjects With Unsolicited AEs - Booster Period|"An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination."|During the 31-day (Days 0-30) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented.|||Participants|||Count of Participants
2653878|NCT01641133|Secondary|Number of Subjects With Unsolicited AEs - Primary Period|"An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination."|During the 31-day (Days 0-30) post-primary vaccination period|The analysis was performed on the Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented.|||Participants|||Count of Participants
2653879|NCT01641133|Secondary|Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period|The number of subjects with any and grade 3 symptoms (solicited and unsolicited), during the 31-day post-booster vaccination period is reported.|During the 31-day (Days 0-30) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in.|||Participants|||Count of Participants
2653880|NCT01641133|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period|"Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Any is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination."|During the 4-day (Days 0-3) post-booster vaccination period|The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in.|||Participants|||Count of Participants
2653881|NCT01641133|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period|"Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Any is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination."|During the 4-day (Days 0-3) post-vaccination period following each primary dose|The analysis was performed on The Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented and the symptom sheet filled in.|||Participants|||Count of Participants
2653883|NCT01641133|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period|"Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). Any is defined as incidence of the specified symptom regardless of intensity."|During the 4-day (Days 0-3) post-vaccination period following each primary dose|The analysis was performed on The Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented and the symptom sheet filled in.|||Participants|||Count of Participants
2653884|NCT01641133|Primary|Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period|The number of subjects with Grade 3 AEs (solicited and unsolicited), during the 31-day post-vaccination period following each primary dose is reported.|Within 31-day (Day 0-Day 30) after any dose of primary vaccination|The analysis was performed on the Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented and the symptom sheet filled in.|||Participants|||Count of Participants
2653885|NCT01641120|Secondary|Perception of Needle|"Secondary endpoint was assessment of the perception of the needle based on patient questionnaires completed after each injection. The patient will respond to each statement on a scale which ranges from 1 (strongly agree) to 5 (strongly disagree).~A total of 6 statements were given to the participant the more strongly the participant agreed with the statement, the more favorably they perceived the needle.~Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. Mean describes perception of the 30 gauge needle.~Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. Mean describes perception of the 25 gauge needle."|Weeks 2, 3, 4, 5||||units on a scale||Standard Deviation|Mean
2653886|NCT01641120|Primary|Visual Analog Scale Score for Post-injection Pain|"The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for post-injection pain.VAS scale (min=0 - max=100 mm (10 cm)) 0= no pain; 100 mm (10 cm)=very severe pain.~Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for post-injection pain for that needle size.~Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for post-injection pain for that needle size."|Weeks 2, 3, 4, 5||||cm||Standard Deviation|Mean
2653887|NCT01641120|Secondary|Fear of Injection|"Secondary endpoint was assessment of fear of injection based on patient questionnaires completed prior to each injection. The patient will respond to each statement on a scale which ranges from 1 (almost always) to 4 (almost never).~Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. Mean describes fear of injection for the 30 gauge needle.~Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. Mean describes fear of injection for the 25 gauge needle."|Weeks 2, 3, 4, 5||||units on a scale||Standard Deviation|Mean
2653888|NCT01641120|Primary|Change in Patient Visual Analog Scale Score for Pre-injection Anxiety|"The primary endpoint of the study was a change in patient self-reported 100 mm (10 cm) Visual Analogue Scale (VAS) score for pre-injection anxiety. VAS scale (min=0- max=100 mm (10cm)) 0= no anxiety; 100 mm (10 cm)=very severe anxiety.~Data from Weeks 2 and 3 were combined and averaged to obtain a single value as both weeks a 30 gauge needle was used for injection. The 30 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size.~Data from Weeks 4 and 5 were combined and averaged to obtain a single value as both weeks a 25 gauge needle was used for injection. The 25 gauge needle VAS mean refers to the mean for pre-injection anxiety for that needle size."|Weeks 2, 3, 4, 5||||cm||Standard Deviation|Mean
2653889|NCT01641081|Secondary|Change From Baseline in Normalized FEV1 AUC0-6 After the Morning Dose (Day 1)|AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of Period 1 The time-normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals|Baseline and up to 6 hrs post-dose (±15 min) on Day 1 of treatment|Intent to treat (ITT) Population defined as all patients in the Safety Population who had a baseline and at least 1 post-baseline FEV1 assessment|||Liters||Standard Error|Least Squares Mean
2653890|NCT01641081|Primary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14)|AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of each treatment period The normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals|Baseline and up to 6 hrs post-dose (±15 min) on Day 14 of treatment|Intent to treat (ITT) Population defined as all patients in the Safety Population who had a baseline and at least 1 post-baseline FEV1 assessment|||Liters||Standard Error|Least Squares Mean
2653891|NCT01641042|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Month 0 until the end of the ESFU (at Month 8)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2653892|NCT01641042|Secondary|Number of Subjects Reporting Any Unsolicited AEs|An unsolicited AE covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.|During the 31-day (Days 0-30) post second vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2657195|NCT01607853|Secondary|Change From Baseline in Erythema at Day 15|Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 15||||units on a scale||Standard Deviation|Mean
2653893|NCT01641042|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited adverse event (AE) covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.|During the 31-day (Days 0-30) post first vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2653894|NCT01641042|Secondary|Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.|From Month 0 until the end of the Extended Safety Follow-Up [ESFU] (at Month 8)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.|||Participants|||Count of Participants
2653895|NCT01641042|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever. Gastrointestinal symptoms include nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature >39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.|||Participants|||Count of Participants
2653896|NCT01641042|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature >39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.|||Participants|||Count of Participants
2653897|NCT01641042|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years|Assessed solicited local symptoms were pain, redness and swelling. Any was defined as occurrence of the symptom regardless of intensity grade. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.|||Participants|||Count of Participants
2653898|NCT01641042|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|During the 4-day (Days 0-3) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.|||Participants|||Count of Participants
2653899|NCT01641042|Secondary|Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens|Antibody titers were measured in geometric mean concentrations (GMCs), calculated on all subjects.|Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2653900|NCT01641042|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values|The cut-off value for the assay was ≥ 2.0 μg/mL.|Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
2653901|NCT01641042|Secondary|Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values|The cut-off value for the assay was ≥ 0.3 micrograms per milliliter (μg/m).|Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
2653902|NCT01641042|Secondary|Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens|Antibody titers were measured in Geometric mean titers (GMTs), calculated on all subjects.|Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Titres||95% Confidence Interval|Geometric Mean
2653903|NCT01641042|Secondary|Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values|The cut-off value for the assay ≥ 1:8.|Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
2653905|NCT01641042|Secondary|Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens|Antibody titers were measured in geometric mean titers (GMTs), calculated on all subjects.|At pre-primary vaccination (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2653906|NCT01641042|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values|The cut-off value for the assay was ≥ 1:128.|Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
2653907|NCT01641042|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values|The cut-off value for the assay was ≥ 1:8.|At pre-primary vaccination (Month 0), at post first vaccine dose (Month 1) and post second vaccine dose (Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
2653908|NCT01641042|Secondary|Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies|Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers < 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4).|One month after the second vaccine dose (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
2653909|NCT01641042|Secondary|Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies|Vaccine response was defined as: rSBA antibody titers ≥ 1:32, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers < 1:8) and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).|One month after the second vaccine dose (At Month 3)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
2653910|NCT01641042|Primary|Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies|Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers < 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4).|One month after the first vaccine dose (at Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
2653911|NCT01641042|Primary|Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies|Vaccine response was defined as: rSBA antibody titers greater than or equal to (≥) 1:32, for initially seronegative subjects [i.e. pre-vaccination rSBA antibody titers below (<) 1:8] and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).|One month after the first vaccine dose (at Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.|||Participants|||Count of Participants
2653912|NCT01640964|Secondary|Number of Patients With Total Adverse Events, Serious Adverse and Death as Assessment of Safety and Tolerability of Serelaxin|This endpoint reports patients with any adverse event, serious adverse event and death for the serelaxin group of Part A and Part B of the study.|4 weeks|Safety assessment happened on full analysis set which included all patients who received any amount of study treatment during the treatment period and had at least one post-Baseline assessment during that period.|||Patients|||Number
2653913|NCT01640964|Secondary|Change From Baseline of the Portal Vein Pressure (PVP) (Study Part B)|Portal vein pressure was measured at 15 min intervals (i.e. prior to and at 15, 30, 45, 60, 75, 90, 105, and 120 min of serelaxin infusion).|Baseline, 120 min post infusion|For Part B of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and this time point are included.|||mmHg||95% Confidence Interval|Mean
2653914|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Portal Vein (Study Part A (Serelaxin Treatment Group Only))|"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as the portal vein. The flow is the average flow over the cardiac cycle.~Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)."|Baseline, 120 min post-infusion|For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included|||L/min||95% Confidence Interval|Mean
2653915|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Descending Thoracic Aorta (Study Part A (Serelaxin Treatment Group Only))|"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as descending thoracic aorta. The flow is the average flow over the cardiac cycle.~Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)."|Baseline, 120 min post-infusion|For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included|||L/min||95% Confidence Interval|Mean
2653916|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Superior Mesenteric Artery (Study Part A (Serelaxin Treatment Group Only))|"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as superior mesenteric artery. The flow is the average flow over the cardiac cycle.~Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)."|Baseline, 120 min post-infusion|For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included|||L/min||95% Confidence Interval|Mean
2653917|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Hepatic Artery (Study Part A (Serelaxin Treatment Group Only))|"A non-contrast magnetic resonance angiography (MRA) sequence was performed to acquire phase contrast blood flow measurements from vessels of interest such as hepatic artery. The flow is the average flow over the cardiac cycle.~Baseline blood flow measurements are measured at pre-dose (Day 1, 0 min post-treatment)."|Baseline, 120 min post-infusion|For the part A of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period. Only patients with a value at both baseline and at the time point are included|||L/min||95% Confidence Interval|Mean
2653918|NCT01640964|Secondary|Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Terlipressin Acetate Group Only))|The flow is the average flow over the cardiac cycle. Total renal artery flow = left renal artery flow + right renal artery flow. These measurements were collected through magnetic resonance angiography (MRA) scans. Baseline blood flow for total renal artery is measured at pre-dose (Day 1, 0 min post-treatment)|Baseline, 120 min post infusion|Full analysis set (FAS) included all patients who received any amount of study treatment during the treatment period and had at least one post-Baseline assessment during that period.|||L/min||95% Confidence Interval|Mean
2653919|NCT01640964|Primary|Change From Baseline of the Portal Pressure Gradient (PPG) (Study Part B)|"Direct venous pressure was measured by portal pressure gradient (PPG). PPG = portal vein pressure (PVP) - inferior vena cava pressure (IVCP).~Baseline blood flow for PPG was measured at pre-dose (Day 1, 0 min post-treatment). PVP was measured at 15 min intervals (i.e. prior to and at 15, 30, 45, 60, 75, 90, 105, and 120 min of serelaxin infusion)."|Baseline, 120 min post-infusion start|For Part B of the study, full analysis set included all patients who received any amount of study treatment during the treatment period and had at least one post-baseline assessment during that period.Only patients with a value at both baseline and this time point are included.|||mmHg||95% Confidence Interval|Mean
2653920|NCT01640964|Primary|Change From Baseline of the Blood Flow for the Total Renal Arteries (Study Part A (Serelaxin Treatment Group Only))|The flow is the average flow over the cardiac cycle. Total renal artery flow = left renal artery flow + right renal artery flow. These measurements were collected through magnetic resonance angiography (MRA) scans. Baseline blood flow for total renal artery is measured at pre-dose (Day 1, 0 min post-treatment)|Baseline, 120 min post serelaxin infusion|Full analysis set (FAS) included all patients who received any amount of study treatment during the treatment period and had at least one post-Baseline assessment during that period.|||L/min||95% Confidence Interval|Mean
2653921|NCT01640951|Secondary|Percentage of Patients With Experiencing a Rebound|"Rebound of disease is defined as a worsening of PASI of > 125% of the value at baseline (core study), or new pustular, erythrodermic or more inflammatory psoriasis occurring within 8 weeks of stopping therapy (i.e., if this definition was fulfilled at more than 8 weeks after last study treatment administration, this was defined as rebound like event).~PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement."|Up to Week 264 (8 weeks post last dose)|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||Percentage of participants||95% Confidence Interval|Number
2653922|NCT01640951|Secondary|Percentage of Patients With Experiencing a Relapse|"Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline.~PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement."|Week 260|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||Percentage of Participants|||Number
2653923|NCT01640951|Secondary|Number of Participants With Treatment Emergent Anti-drug Antibodies (ADA)|The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment.|Week 268|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only descriptive analysis done.|||Participants|||Number
2653924|NCT01640951|Secondary|EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D©) Score and Percent Change From Baseline at Weeks 52, 104 and 156|"ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example confined to bed) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)"|Baseline, Week 52, Week 104, Week 156|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||Percent change||Standard Deviation|Mean
2653925|NCT01640951|Secondary|Percentage of Participants With Dermatology Life Quality Index (DLQI©) Response (DLQI 0 or 1) Over Time at Weeks 52, 104, 156, 208 and 260|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Week 52, Week 104, Week 156, Week 208, Week 260|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||Percentage of participants|||Number
2653926|NCT01640951|Secondary|Percentage Change From Baseline in Dermatology Life Quality Index (DLQI©) Response at Weeks 52, 104, 156, 208 and 260|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Baseline, Week 52, Week 104, Week 156, Week 208, Week 260|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||Percent change||95% Confidence Interval|Median
2653927|NCT01640951|Secondary|Percentage of Participants Achieving Investigator's Global Assessment Modified 2011 (IGA) 2011 Score of 0 or 1 Over Time at Weeks 52, 104, 156, 208 and 260|The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe). The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe.|Week 52, Week 104, Week 156, Week 208, Week 260|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||Percentage of Participants|||Number
2653928|NCT01640951|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 52, 104, 156, 208 and 260|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)|Baseline, Week 52, Week 104, Week 156, Week 208, Week 260|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||Percent change||Standard Deviation|Mean
2653929|NCT01640951|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Scores of 50, 90 and 100 Over Time at Weeks 52, 104, 156, 208 and 260|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)|Week 52, Week 104, Week 156, Week 208, Week 260|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||Percentage of Participants|||Number
2653930|NCT01640951|Secondary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) Score of 75 at Weeks 52, 104, 156, 208 and 260|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area * area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)|Week 52, Week 104, Week 156, Week 208, Week 260|The full analysis set (FAS), which consisted of all participants with an observed value, was considered. Only patients with evaluable data at each time point were analyzed for that time point. Only descriptive analysis done.|||Percentage of Participants|||Number
2653931|NCT01640951|Primary|Long-term Safety and Tolerability of Secukinumab|Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC)|Week 268|Safety Set. All subjects who took at least one dose of study treatment during the extension treatment period. A subject with multiple adverse events within a primary system organ class was counted only once in the total row. Deaths up to 28 days after the last dose are included. Only descriptive analysis done.|||Percentage of participants|||Number
2653932|NCT01640925|Secondary|Number of Patients With In-hospital Mortality||up to 28 days or until first hospital discharge||||Participants|||Count of Participants
2653935|NCT01640925|Primary|Incidence of Nosocomial Infection|"Proportion of patients with one or more incident nosocomial infections.~Primary Efficacy Endpoints* (Composite of new nosocomial infection)~Primary Bloodstream Infection~Catheter Related Urinary Tract Infection~Ventilator-Associated Pneumonia**~Surgical Site Infection~(*)Diagnosed using the Centers for Disease Control criteria for hospital acquired infections. Only infections that develop 48 hours or more after study enrollment will be counted as primary endpoints.~(**)Ventilator associated pneumonia is defined as pneumonia that developed after 48 hours of mechanical ventilation."|Up to 28 days||||participants|||Number
2653936|NCT01640873|Secondary|Change From Baseline at 2 Hours Oral Glucose Tolerance Test|Plasma glucose excursion was assessed during an oral glucose tolerance test (oGTT) following a single dose administration of MK-8655 in participants with T2DM.|Baseline and 2 hours after dosing on Days 1, 3, and 16|The analysis population was participants who complied with the protocol sufficiently to ensure that these data would likely exhibit the effects of treatment, according to the underlying scientific model. Compliance covered such considerations as exposure to treatment, availability of measurements and absence of major protocol violations.|||mg/dL||Standard Deviation|Mean
2653937|NCT01640873|Secondary|24-Hour Weighted Mean Glucose (WMG)|The WMG provides an integrated assessment of the glycemic exposure over the 24-hour period. To reduce variability of the baseline (before any study drug administration) WMG, participants were domiciled in the test facility at least 36 hours prior to Day 1, where standard meals were provided, and physical activity was monitored. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The sample scheme for the 18 point glucose measurements used in this study had many samples taken in the very early morning hours, as well as the first three hours after meals. WMG was calculated as the area under the curve (AUC) of the glucose concentrations divided by the duration of time of samples collected.|Day 15: Predose, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 18, 21, 23 hours post-dose.|The analysis population was participants who complied with the protocol sufficiently to ensure that these data would likely exhibit the effects of treatment, according to the underlying scientific model. Compliance covered such considerations as exposure to treatment, availability of measurements and absence of major protocol violations.|||mg/dL||Standard Deviation|Mean
2653938|NCT01640873|Secondary|True Geometric Mean Plasma Concentrations of MK-8655 After Single and Multiple Drug Doses at 24 Hours Post Dose (C24)|C24hr was log transformed and analyzed based on a linear mixed effects model containing fixed effects for treatment, day and treatment by day interaction and a random effect for the participant.|24 hours post dose on Days 1, 7, and 14|The analysis population was participants who complied with the protocol sufficiently to ensure that these data would likely exhibit the effects of treatment, according to the underlying scientific model. No pharmacokinetic analysis for C24 was performed for participants receiving placebo.|||uM||Geometric Coefficient of Variation|Geometric Mean
2653939|NCT01640873|Primary|Fasting Plasma Glucose (FPG)|Blood for fasting plasma glucose (central laboratory) was obtained after at least 10 hours overnight fast.|Day 16 (Predose)|The analysis population was participants who complied with the protocol sufficiently to ensure that these data would likely exhibit the effects of treatment, according to the underlying scientific model. Compliance covered such considerations as exposure to treatment, availability of measurements and absence of major protocol violations.|||mg/dL||Standard Deviation|Mean
2653940|NCT01640873|Primary|Number of Participants Discontinuing Study Drug Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 17 days|All participants who received at least one dose of the investigational drug.|||Participants|||Count of Participants
2653941|NCT01640873|Primary|Number of Participants With One or More Adverse Events|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 14 days after the last dose of study drug (Up to 31 days)|All participants who received at least one dose of the investigational drug.|||Participants|||Count of Participants
2653942|NCT01640834|Secondary|Pharmacodynamics: Area Under the Glucose Concentration Curve After a Single Dose of Glucagon on Day 3|Area under the glucose concentration curve from time 0 through 2 hours after a single dose of glucagon (1 milligram) administered via an intramuscular injection is reported.|Day 3|All participants who received a dose of LY2409021 or placebo and had evaluable post-glucagon injection glucose concentration data.|||milligrams * minutes per deciliter||Geometric Coefficient of Variation|Geometric Mean
2653943|NCT01640834|Secondary|Pharmacodynamics: Maximum Concentration (Cmax) of Glucose Concentration After 1 Milligram (mg) Glucagon Injection on Day 3|The Cmax of glucose following a single dose of glucagon (1 mg) administered via an intramuscular injection is reported.|Day 3|All participants who received a dose of LY2409021 or placebo and had evaluable post-glucagon injection glucose concentration data.|||milligrams per deciliter||Geometric Coefficient of Variation|Geometric Mean
2653944|NCT01640834|Secondary|Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose Needed to Maintain Euglycemia|Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.|Baseline (Day 1), Day 3 up to Day 6|This outcome measure was not analyzed.||||||
2653945|NCT01640834|Secondary|Pharmacodynamics: Change From Baseline in 24 Hour Insulin Dose During Drug Washout Period|Data were not captured, and, therefore, this outcome measure was not analyzed. Zero participants were included in the analysis.|Baseline (Day 1), Day 3 up to Day 6|This outcome measure was not analyzed.||||||
2653946|NCT01640834|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021|Exposure in terms of AUC of LY2409021 from time 0 extrapolated to infinity (AUCinf) is reported.|Predose (Day 2) through 120 hours postdose (Day 7)|All participants who received a dose of LY2409021 and had evaluable pharmacokinetic data.|||nanograms * hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
2653947|NCT01640834|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021||Predose (Day 2) through 120 hours postdose (Day 7)|All participants who received a dose of LY2409021 and had evaluable pharmacokinetic data.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2653948|NCT01640834|Secondary|Pharmacodynamics: Percentage Change From Baseline to Day 2 in 24-hour Insulin|The percentage change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.|Baseline (Day 1), Day 2|All participants who received a dose of LY2409021 or placebo and had evaluable 24-hour insulin data.|||percentage of insulin units||Standard Deviation|Mean
2653949|NCT01640834|Primary|Pharmacodynamics: Change From Baseline to Day 2 in 24-hour Insulin Dose|The mean absolute change in total insulin dose over 24 hours (Day 2, 24-hour insulin dose - Day 1, 24-hour insulin dose) is reported.|Baseline (Day 1), Day 2|All participants who received a dose of LY2409021 or placebo and had evaluable 24-hour insulin data.|||insulin units||Standard Deviation|Mean
2653950|NCT01640548|Secondary|Duration of Treatment of bDMARD Administered With Concomitant Traditional DMARD as Previous Treatment for RA||9 months|"Included participants who were treated with a bDMARD with concomitant traditional DMARD as previous treatment for RA. n is the number of participants who received particular bDMARD as previous RA treatment."|||months||Full Range|Median
2653951|NCT01640548|Secondary|Duration of Treatment With bDMARDs in Monotherapy as Previous Treatment for RA||9 months|"Included participants treated with a bDMARD monotherapy as previous treatment for RA prior to switch to current bDMARD monotherapy. n is the number of participants who received particular bDMARD as previous RA treatment."|||months||Full Range|Median
2653952|NCT01640548|Secondary|Duration of Treatment With the Current bDMARD Usage in Monotherapy||9 months|"Included all participants who received bDMARD monotherapy as their current treatment for RA. n is the number of participants who received that particular bDMARD as their current RA treatment."|||months||Full Range|Median
2653953|NCT01640548|Primary|Percentage of Participants by Reason for Choosing Previous and Current bDMARDs in Monotherapy|Both previous and current bDMARDs were presented together for each subgroup, therefore the percentage of participants under each reason did not add up to 100%.|9 months|Included all participants who entered the retrospective chart review.|||percentage of participants||95% Confidence Interval|Number
2653954|NCT01640548|Secondary|Total Number of Tender Joints and Swollen Joints and Non-Evaluable DAS 28 Joints When Assessed Using Both ESR and CRP Methods|DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, ESR (in millimeters/hour) or CRP (in milligrams/liter), and the participant's global assessment of disease activity (visual analog scale: 0=no disease activity to 100=maximum disease activity). TJC and SJC assessed as part of the DAS28 outcome measure assessment were reported.|9 months|"Includes all participants who were evaluable for this outcome. n represents the number of participants who were evaluable for that particular assessment."|||joints count||95% Confidence Interval|Mean
2653955|NCT01640548|Primary|Percentage of Participants With Concomitant Treatment Other Than DMARDs for RA by Type of Treatment|All corticosteroids and non-steroidal anti-inflammatory drugs taken as previous and current treatments for RA were coded according to the Roche international non-proprietary name dictionary.|9 months|Included all the participants who entered the retrospective chart review.|||percentage of participants|||Number
2653956|NCT01640548|Secondary|Assessment of Disease Activity Score of 28 Joint Count (DAS28) by Either Erythrocyte Sedimentation Ratio (ESR) or C-Reactive Protein (CRP)|DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, ESR (in millimeters/hour) or CRP (in milligrams/liter), and the participant's global assessment of disease activity (visual analog scale: 0=no disease activity to 100=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56 x square root (√) of TJC + 0.28 x √(SJC) + 0.70 x log natural (ESR) + 0.014 x global assessment of RA score. The formula for calculating DAS28 score using CRP value is: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x log natural (CRP+1) + 0.014 x global assessment of RA score +0.96. The DAS28 score range was 0-9.4 where higher scores represented higher disease activity.|9 months|"Included the number of participants who were evaluable for DAS28 assessment. n represents the number of participants who were evaluable for that particular assessment."|||scores on a scale||95% Confidence Interval|Mean
2653957|NCT01640548|Primary|Percentage of Participants With bDMARD Monotherapy as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy|bDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Only the most frequently used (> 10% of participants) bDMARDs in monotherapy as previous treatment for RA were reported. If a participant was recorded to have been treated with a single bDMARD more than once, the participant was counted only once per type of bDMARD. If participant received 2 different types of bDMARDs as part of their previous treatment, the participant was counted twice, once per each type of bDMARD; therefore, the percentage of participants did not add up to 100%.|9 months|Included participants who received bDMARD as monotherapy as previous treatment prior to switch to bDMARD monotherapy as current treatment.|||percentage of participants|||Number
2653958|NCT01640548|Primary|Percentage of Participants With bDMARD and Concomitant Traditional DMARD Regimen as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy by Type of bDMARD|bDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Only the most frequently used (> 10% of participants) bDMARDs with concomitant traditional DMARD as previous treatment for RA were reported. If a participant was recorded to have been treated with a single bDMARD more than once, the participant was counted only once per type of bDMARD. If participant received 2 different types of bDMARDs as part of their previous treatment, the participant was counted twice, once per each type of bDMARD; therefore, the percentage of participants did not add up to 100%.|9 months|Included participants who were previously treated with any bDMARD with concomitant traditional DMARD prior to switch to bDMARD monotherapy as current RA treatment.|||percentage of participants|||Number
2653959|NCT01640548|Primary|Percentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARD|Traditional DMARDS for RA treatment include methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, gold compounds, penicillamine, cyclosporine, azathioprine, chlorambucil, mercaptopurine, and mycophenolate mofetil medications. Previous RA treatment included all the treatments received prior to switching to current RA treatment.|9 months|Included all the participants who took any past traditional DMARDs.|||percentage of participants|||Number
2655260|NCT01628107|Secondary|Mean Hemoglobin Levels for Interval of 12 Weeks||Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value.|||g/dL||Standard Deviation|Mean
2653960|NCT01640548|Primary|Percentage (%) of Participants Receiving Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in Monotherapy as Current Treatment for RA According to National Institute for Health and Clinical Excellence (NICE) Guidelines by Type of bDMARD|bDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Current bDMARDs were defined as those with a start date on or after the date of collection, or those with a start date before the date of collection and an end date on or after the date of collection. NICE guidelines recommend the participants with severe active RA who inadequately responded to prior DMARD treatment (trial of 2 DMARDs, one which includes methotrexate) and were intolerant to methotrexate or the treatment with methotrexate considered inappropriate be treated with a biologic DMARD monotherapy.|9 months|Included all the participants who entered the retrospective chart review.|||percentage of participants|||Number
2653961|NCT01640379|Secondary|Number of Participants That Adhered to Self-treatment|Completion of 72-hour assessment visit by medical provider, medication adherence (self-reported), partner notification, partner treatment, and temporary sexual abstinence|Day 15|Chi-square test results from participants in the intervention and control groups who had data on adherence to treatment. Out of 149 enrolled in the intervention arm, 10 were lost to followup by 72 hours. Out of 137 enrolled in the control arm, 15 were lost by 72 hours and so are missing this outcome measure.|||Participants|||Count of Participants
2653962|NCT01640379|Primary|Number of Participants With Positive Sexually Transmitted Infection Test (STI)|STI testing (positive Neisseria gonorrhoeae (GC) or Chlamydia trachomatis CT) tested at 90 days using nucleic acid amplification testing (NAAT).|90 Days|Adolescent and young adult women with pelvic inflammatory disease (PID) in Baltimore City randomized to the intervention or control group and also had results for chlamydia (CT) and gonorrhea (GC) at 90 days after enrollment. All enrolled participants were followed as long as possible for entire 90 days.|||Participants|||Count of Participants
2653963|NCT01640366|Secondary|Number of Wounds Showing 100% Closure Occurring up to and 21 Days Postoperatively|"Assessment of wound appearance demonstrating 100% wound closure at 21 days postoperatively for both PICO treatment and standard of care treatment.~All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO."|21 days postoperatively|There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results for this time point.|||Participants|||Count of Participants
2653964|NCT01640366|Secondary|Number of Hematoma's Occurring up to and 21 Days Postoperatively|"Assessment of participants developing a hematoma up to 21 days postoperatively for incisions treated with PICO compared with standard care dressings.~All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO."|21 days postoperatively|There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results for this time point.|||Participants|||Count of Participants
2653965|NCT01640366|Secondary|Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively|"The nipple and areola areas were not covered by the PICO or standard care dressing as part of the evaluation, they were all dressed the same with Steri-strips and dry gauze pads, which was essentially the standard care dressing regime.~All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO."|21 days postoperatively|There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results for this time point.|||Participants|||Count of Participants
2653966|NCT01640366|Secondary|Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively|"Assessment of the Patient and Observer Scar Assessment Scale (POSAS) and the Visual Analogue Scale (VAS) between postsurgical incisions treated with PICO compared with standard care dressings.~VAS score: Assessed for color, appearance, contour, distortion, and texture. Each score ranged from 5 to 18; 5 being 'excellent' and 18 being 'poor.' Also, a global scar score was included in the total score.~POSAS score: Scored in 2 parts which added to create a total score, observer score and patient score. The lowest score of 1 showed 'normal' skin and the highest score of 10 showed the 'worst imaginable' result.~Observer score = 6 categories (vascularity, pigmentation, thickness, relief, pliability, and surface area) each given a score of 1-10.~Patient score = 6 categories (scar pain, itching, color, stiffness, thickness, and irregularity each given a score of 1-10.~All participants received both PICO and standard care dressings simultaneously during the course of the study."|90 days postoperatively|There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results at the 90 day time point.|||score on a scale||Inter-Quartile Range|Median
2653967|NCT01640366|Secondary|Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively|"Assessment of the number of participants' incisions that experienced delayed healing within 10 days of surgery between incisions treated with PICO compared with standard care dressings.~All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO."|Within 10 days postoperatively|There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery.|||participants|||Number
2653968|NCT01640366|Secondary|Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively|"Assessment of the number of participants' incisions that experienced delayed healing within 7 days of surgery between incisions treated with PICO compared with standard care dressings.~All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO."|Within 7 days postoperatively|There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery.|||participants|||Number
2653985|NCT01640340|Primary|Overall CR(Complete Response)After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication|We will use exact binomial methods to estimate proportions and their associated 95% confidence intervals.|Up to 120 hours after completion of chemotherapy||||percentage of patients||95% Confidence Interval|Number
2653969|NCT01640366|Secondary|Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively|"Assessment of the number of participants' incisions that experienced an infection (superficial or deep) occurring up to and 21 days postoperatively between incisions treated with PICO compared with standard care dressings.~All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO."|21 days postoperatively|There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results at this time point.|||participants|||Number
2653970|NCT01640366|Secondary|Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively|"Assessment of the number of participants' incisions that experienced dehiscence (superficial, partial, or deep) occurring up to and 21 days postoperatively between incisions treated with PICO compared with standard care dressings.~All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO."|21 days postoperatively|There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery. All available results at this time point.|||participants|||Number
2653971|NCT01640366|Primary|Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively|"The primary variable of whether or not the incision developed a healing complication within 21 days of surgery was defined as the presence of at least one of the following:~Infection (superficial or deep),~Dehiscence (partial, superficial or deep),~Delayed healing (defined as incision not closed within 7 days of the first surgical procedure).~All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast for PICO and left breast for standard of care OR right breast standard of care and left breast PICO."|21 days postoperatively|There were 200 participants enrolled with 1 participant lost to follow-up immediately after surgery.|||participants|||Number
2653972|NCT01640353|Secondary|Serious Adverse Events|Occurrence of adverse events meeting the ISO14155:2011 definition of serious occurring during the procedure, at the time of hospital discharge (typically day of or next day after procedure), and at various times in late follow-up.|Procedure, discharge, 1,3,6,12,18 and 24 months|149 participants had 24 months of follow up post-operatively.|||serious adverse event|||Number
2653973|NCT01640353|Secondary|Work Status|Proportion of non-working subjects who return to work|Basline, 24 months|Participants with work status data at 24 months post-operatively who were not working due to back pain (at baseline 37.4% were not working due to back pain).|||percentage of participants|||Number
2653974|NCT01640353|Secondary|Ambulatory Status|Percentage of population fully ambulatory at 24 months post operatively.|24 months|148 participants had ambulatory status at 24 month post-operatively|||percentage of participants|||Number
2653975|NCT01640353|Secondary|Change in Quality of Life|Change in QOL as measured by Short Form-36 PCS and EQ-5D at post-operative visits|Baseline and 24 months|148 participants had QOL information at 24 months post-operatively.|||units on a scale||Standard Deviation|Mean
2653976|NCT01640353|Secondary|Change in Back Dysfunction|Oswestry Disability Index is a validated patient questionnaire aiming to assess low back pain. The computed scores can be 0% to 100%. Lower scores indicate low disability while high scores indicate high disability. There are 10 questions on the questionnaire. Each has 6 possible answers (0 points - 5 points). If the question is skipped, it's points are subtracted from the denominator. If the raw score is 30 and all 10 questions were answered, the calculation would be 30 / 50 = 60%. If one question was skipped, it would be 30 / 45 = 67%.|24 months|147 of participants had ODI at 24 months post-operatively.|||units on a scale||Standard Deviation|Mean
2653977|NCT01640353|Secondary|Change in SI Joint Pain on Visual Analog Scale (VAS) (0-100 mm)|The Visual Analog Scale (VAS) is a 100 mm line on which the subject indicates their level of pain. 0 = no pain. 100 = worst imaginable pain.|24 months|148 subjects had SIJ pain scores at 24 months.|||units on a scale||Standard Deviation|Mean
2653978|NCT01640353|Primary|Subject Success|Composite endpoint of reduction from baseline in VAS back pain score by at least 20 mm, lack of device-related serious adverse events, absence of neurologic worsening and absence of surgical re-intervention.|Baseline and 6 months|Of 194 subjects who were eligible and signed informed consent, 10 voluntarily withdrew prior to SIJF. All data from 12 subjects at a single center were excluded due to early termination of the site. 172 subjects were treated. 168 had 6 months of follow up.|||percentage of participants||95% Confidence Interval|Number
2653979|NCT01640340|Secondary|Percentage of Patients Who Experienced Grade 1, 2 or 3 Vomiting From Time 0 to 120 Hours|The percentage of patients who experienced grade 1, 2 or 3 vomiting from time 0 to 120 hours. Nausea graded using the National Cancer Institute (NCI) CTCAE v 4.0 vomiting Grading Scale. Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.|From time 0 to 120 hours||||percentage of participants|||Number
2653980|NCT01640340|Secondary|Use of Rescue Medication for Each Treatment Arm||From time 0 to 120 hours||||percentage of participants|||Number
2653981|NCT01640340|Secondary|Visual Analog Scale (VAS) Scores||Up to 7 days after completion of study treatment|VAS Scores were not collected||||||
2653982|NCT01640340|Secondary|Percentage of Patients Who Experienced Grade 1, 2 or 3 Nausea From Time 0 to 120 Hours|The percentage of patients who experienced grade 1, 2 or 3 nausea from time 0 to 120 hours. Nausea graded using the National Cancer Institute (NCI) CTCAE (Common Toxicity Criteria for Adverse Effects)version 4.0 Nausea Grading Scale. Grade 1=Loss of appetite without alteration in eating habits, Grade 2= Oral intake decreased without significant weight loss, dehydration or malnutrition, Grade 3= Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated.|Time 0 to 120 hours||||percentage of participants|||Number
2653983|NCT01640340|Secondary|Delayed CR (Complete Response)|After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication From Time 24to 120 Hours.|24-120 hours after chemotherapy||||percentage of participants|||Number
2653984|NCT01640340|Secondary|Acute CR (Complete Response)|After the First Course of HEC, Defined as no Emesis and no Use of Rescue Medication from time 0 to 24 hours.|0-24 hours after chemotherapy||||percentage of particpants|||Number
2653986|NCT01640327|Secondary|Numbers of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination)|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after the TIVf vaccination.|From day 1 through day 4 postvaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.|||Subjects|||Number
2653987|NCT01640327|Primary|Percentage of Subjects Who Achieved HI Titer ≥40 Against Each of Three Vaccine Strains After One Vaccination of TIVf|"Immunogenicity was measured as the percentage of subjects achieving HI titer ≥40 against each of three vaccine strains at baseline (day 1) and three weeks after TIVf vaccination (day 22).~This criterion was met according to CHMP guideline if percentage of subjects achieving HI titer ≥40 is >70% (≥18 years to ≤60) or >60% (≥61 years)."|Day 1 and 22|Analysis was done on the PP set.|||Percentages of Subjects||95% Confidence Interval|Number
2653988|NCT01640327|Primary|Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIVf|"Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI geometric mean titers (GMTs), directed against each of three vaccine strains, three weeks after vaccination (day 22).~The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in HI antibody titer was >2.5 (≥18 years to ≤60 years) or >2.0 (≥61 years)."|Day 22|Analysis was done on the PP set.|||Ratio||95% Confidence Interval|Number
2653989|NCT01640327|Primary|Percentage of Subjects With Seroconversion or Significant Increase in HI Titer Against Each of Three Vaccine Strains After One Vaccination of TIVf|"Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in hemagglutination inhibition (HI) titer, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using HI antigen assay.~As per the European (CHMP) criteria seroconversion or significant increase in titer was defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination HI titer ≥40; or in subjects with a prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer.~This criterion was met according to CHMP guideline if percentage of subjects achieving seroconversion or significant increase in HI titer is >40% (≥18 years to ≤60 years) or >30% (≥61 years)."|Day 22|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||Percentages of Subjects||95% Confidence Interval|Number
2653990|NCT01640314|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIVc.|The number of subjects in both age groups reporting any unsolicited AEs between Day 1 to Day 22 after receiving one dose of TIVc.|Day 1 to Day 22|Analysis was done on the safety set population.|||Number of Subjects|||Number
2653991|NCT01640314|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination)|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after TIVc vaccination.|From day 1 through day 4 postvaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
2653992|NCT01640314|Primary|Percentages of Subjects Who Achieved HI Titer ≥40 Against Each of Three Vaccine Strains After One Vaccination of TIVc|"Immunogenicity was measured as the percentage of subjects achieving HI titer ≥40 against each of three vaccine strains at baseline (day 1) and three weeks after TIVc vaccination (day 22).~This criterion was met according to CHMP guideline if percentage of subjects achieving HI titer ≥40 is >70% (≥18 years to ≤60) or 60% (≥61 years)."|Day 1 and 22|Analysis was done on the PP set.|||Percentages||95% Confidence Interval|Number
2653993|NCT01640314|Primary|Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIVc|"Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI geometric mean titers (GMTs), directed against each of three vaccine strains, three weeks after vaccination (day 22).~The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in HI antibody titer is >2.5 (≥18 years to ≤60 years) or >2.0 (≥61 years)."|Day 22|Analysis was done on the PP set.|||Ratio||95% Confidence Interval|Number
2653994|NCT01640314|Primary|Percentages of Subjects With Seroconversion or Significant Increase in HI Titer Against Each of Three Vaccine Strains After One Vaccination of TIVc|"Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in hemagglutination inhibition (HI) titer, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using HI cell-derived antigen assay.~As per the European (CHMP) criteria, seroconversion or significant increase in titer is defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination HI titer ≥40; or in subjects with a prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. This criterion is met according to CHMP guideline if percentage of subjects achieving seroconversion or significant increase in HI titer is >40% (≥18 years to ≤60 years) or 30% (≥61 years)."|Day 22|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||Percentages||95% Confidence Interval|Number
2653995|NCT01640249|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3006072|PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC[0-inf] of LY3006072.|Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose|All randomized participants who received at least one dose of study drug and have evaluable PK data.|||nanograms * hours per mL (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2653996|NCT01640249|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY3006072||Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdose|All randomized participants who received at least one dose of study drug and have evaluable PK data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2653997|NCT01640249|Primary|Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs|AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible drug relatedness, is located in the Reported Adverse Event module.|Baseline, up to 21 days|All randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2653998|NCT01640197|Secondary|Number of Participants With Significant Modulation of CBF in MCA|CBF was assessed in the middle cerebral artery (MCA) with Trans-cranial doppler via a trans- temporal acoustic window. Participants were deemed to have significant modulation of CBF in the MCA if readings differed significantly from those obtained on day 1 (baseline).|28 days|All participants who were part of the TCD component, who could provide a consistent blood flow trace, were included in the analysis.|||Participants|||Number
2653999|NCT01640197|Secondary|Number of Participants With Significant Modulation of Blood Pressure|Participants were deemed to have significant modulation of blood pressure if their readings on day 28 differed significantly from that taken on day 1 (baseline).|28 days|All participants who provided all BP readings across the study were included in the analysis.|||Participants|||Number
2654000|NCT01640197|Secondary|Number of Participants With Significant Modulation of Health|Subjective perceptions of health were assessed with the General Health Questionnaire. Participants were deemed to have significant modulation of health if scores on Week 1, Week 2, Week 3 and/or Week 4 differed significantly from day 1 (baseline) completion.|Day 28|Participants were included in the analysis if they had completed questionnaires correctly.|||Participants|||Number
2654001|NCT01640197|Secondary|Number of Participants With Significant Modulation of Sleep|Subjective perception of sleep quality was assessed with the PSQI. Participants were deemed to have significant modulation of sleep if scores on Week 1, Week 2, Week 3 and/or Week 4 differed significantly from those on day 1 (baseline).|Day 28|All participants who completed their questionnaires correctly were included in the analysis.|||Participants|||Number
2654002|NCT01640197|Secondary|Number of Participants With Modulated Cognitive Performance|Cognitive performance was assessed by a range of cognitively demanding tasks on day 28 of the supplementation period. Participants were deemed to have significant modulation of cognitive performance if their scores on these tasks were significantly different from scores taken on day 1.|28 days|All participants who properly completed all repetitions of all tasks on both days were included in the analysis.|||Participants|||Number
2654003|NCT01640197|Secondary|Number of Participants With Modulated Mood|Subjective mood was assessed with the Profile of mood states (POMS) questionnaire every 7 days during the 28- day period. Participants were deemed to have significant modulation of mood if their scores on week 1, week 2, week 3 and/or week 4 differed significantly from scores on the baseline questionnaire completed on day 1.|28 days|Participants were included in the final analysis if they had completed all questionnaires correctly.|||Participants|||Number
2654004|NCT01640197|Primary|Chronic Modulation of Cerebral Blood Flow|Cerebral blood flow (CBF) was measured in the frontal cortex with Near-Infrared Spectroscopy (NIRS). Modulation was deemed to have taken place if levels differed significantly from day 1 to day 28.|40- 80 minutes post- dose on day 28 of supplementation|Participants were included in the analysis if they provided full NIRS readings on session 1 and session 2.|||Participants|||Number
2654005|NCT01640184|Secondary|Changes of Blood Levels on Bone Specific Alkaline Phosphatase.|The blood levels of bone specific alkaline phosphatase will be detected at least once every 3 months and will be compared to the baseline levels.|Baseline and 12 months||||microgram/L||Standard Deviation|Mean
2654006|NCT01640184|Secondary|Changes of Blood Levels on iPTH During 12 Months.|The blood levels of iPTH will be detected at least once every 3 months and will be compared to the baseline levels.|Baseline and 12 months||||ng/ml||Standard Deviation|Mean
2654007|NCT01640184|Secondary|Changes of Blood Levels on Phosphorus During 12 Months.|The blood levels of phosphorus will be detected at least once every 3 months and will be compared to the baseline levels.|Baseline and 12 months||||mmol/L||Standard Deviation|Mean
2654008|NCT01640184|Secondary|Changes of the Blood Levels on Calcium During 12 Months.|The blood levels of calcium will be detected at least once every 3 months and will be compared to the baseline levels.|Baseline and 12 months||||mmol/L||Standard Deviation|Mean
2654009|NCT01640184|Secondary|Incidence of Injury on the Recurrent Laryngeal Nerve (RLN).|Comparison of the incidence of RLN injury between ultrasonic ablation group and parathyroidectomy group.|12 months||||participants|||Number
2654010|NCT01640184|Primary|Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines.|The blood levels of intact parathyroid hormone (iPTH) will be detected every 3 months for stable patients. The blood test will be more frequent, at least once per-month, after the ultrasonic ablation treatment, surgery, or during the impulse therapy of active vitamin D with large doses.|12 months|Number of participants analyzed is the number of patients completed study.|||percentage of participants|||Number
2654011|NCT01640171|Secondary|Likert Like Pain Scale Number of Participants Who Said the Topical Eye Hurt Much More Than the Subconjunctival Eye at Time of Intravitreal Injection|The patient was asked to compare the two eyes in the way described in the study protocol on a five point scale. If one eye hurt a lot more or a little more than the other or if the two eyes were equal (neither hurt more than the other).|24 hours|total group|||participants|||Number
2654012|NCT01640171|Secondary|Number of Participatns With Level 10 Pain on Wong-Baker Pain Scale In Subconjunctival Eye At Time of Intravitreal Injection|Pain was rated on a 10 point standardized pain scale, zero was the least pain and 10 was the worst pain. The patient was questioned using a script and shown a pain scale as well as told how the pain scale worked. Then the patient gave the number that characterized their pain.|24 hours|All patients in the study|||participants|||Number
2654013|NCT01640171|Primary|Number of Participants Who Preferred Subconjunctival Anesthetic at the Third Follow-up Visit|Participants received anesthetic over several treatment visits. They were allowed to change there preference at each visit. The final outcome was the preference indicated at the third follow-up visit.|up to 6 months||||participants|||Number
2654014|NCT01640054|Primary|Percentage of Patients Who Had at Least 1 Adverse Event in Any Category|AE = adverse event, IP = investigational product, PO = orally, QD = once daily, SAE = serious adverse event|Entry in extension to study termination (variable duration; maximum 52 weeks)|The full analysis set was the primary population for reporting efficacy and safety data, and comprised all patients who received at least 1 dose of investigational product.|||Percentage of patients|||Number
2654015|NCT01640054|Secondary|SF-36 Score Over Time|n/a = not applicable, PO = orally, QD = once daily, SF-36 = 36 item short form health survey|Every 12 weeks for one year then yearly until study end|Insufficient data were available for analysis due to sparse data collection and the early termination of the study.||||||
2654019|NCT01639872|Primary|Average Over Time of Frequency of Cannabis Use|Frequency of cannabis use is obtained each week retrospectively as the number of days of cannabis use during the prior week (assessed using the Timeline Followback). Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number.|12 weeks|Average number of days of cannabis use over time was calculated using the midpoint 6.5 weeks|||days of cannabis use during prior week||95% Confidence Interval|Number
2654020|NCT01639872|Primary|Average Over Time of Intensity of Cannabis Use (Used to Evaluate Treatment Efficacy)|Intensity of cannabis use is obtained each week retrospectively as the number of joints smoked during the prior week (assessed using the Timeline Followback). Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number.|12 weeks|Average number of joints Over Time was calculated using the midpoint of 6.5 weeks.|||joints smoked during the prior week||95% Confidence Interval|Number
2654021|NCT01639833|Secondary|Hemostasis at All Treated Bleeding Sites Within 3 Minutes|The proportion of subjects achieving hemostasis at all treated bleeding sites within 3 minutes of device application.|Day 0|The Per Protocol (PP) population was used for the primary analysis of the primary effectiveness endpoint for the non-inferiority test.|||percentage of participants||95% Confidence Interval|Number
2654022|NCT01639833|Primary|Time to Hemostasis (TTH)|Time to Hemostasis (TTH) at the target bleeding site (TBS) following treatment (Veriset™ Hemostatic Patch or Control).|Day 0|The Per Protocol (PP) population was used for the primary analysis of the primary effectiveness endpoint for the non-inferiority test.|||minutes||95% Confidence Interval|Median
2654023|NCT01639755|Secondary|Percentage of Participants With Local Complications|The percentage of participants experiencing local complications (in the area of the implant) is reported.|Interim analysis: 12 months|Full analysis population included all participants.|||percentage of participants|||Number
2654024|NCT01639755|Secondary|Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale|The investigator evaluated capsular contracture (lining of cells formed around the device as the body's response to a foreign object) using the Four-Grade Baker scale where: Grade I= Breast is normally soft and looks natural, Grade II= Breast is a little firm but looks normal, Grade III=Breast is firm and looks abnormal or Grade IV= Breast is hard, painful, and looks abnormal. The percentage of participants in each Baker Grade is reported.|Interim analysis: 12 months|Participants from the Full Analysis population with data available for analysis.|||percentage of participants|||Number
2654025|NCT01639755|Secondary|Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue|The investigator examined the breasts and evaluated whether the implant was palpably distinguishable from the tissue using a 5-point scale where 1=implant very easy to distinguish from the tissue to 5=implant indistinguishable from the tissue.|6 months|Full analysis population included all participants.|||score on a scale||Standard Deviation|Mean
2654026|NCT01639755|Secondary|Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire|Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale.|6 months|Full analysis population included all participants.|||score on a scale||Standard Deviation|Mean
2654027|NCT01639755|Primary|Investigator Overall Satisfaction With the Device Using a 5-Point Scale|The investigator evaluated the overall satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.|3 months|Full analysis population included all participants.|||score on a scale||Standard Deviation|Mean
2654028|NCT01639742|Secondary|Percentage of Participants With Local Complications|The percentage of participants experiencing local complications (in the area of the implant) is reported.|Interim analysis: 12 months|Full analysis population included all participants.|||percentage of participants|||Number
2654029|NCT01639742|Secondary|Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale|The investigator evaluated capsular contracture (lining of cells formed around the device as the body's response to a foreign object) using the Four-Grade Baker scale where: Grade I= Breast is normally soft and looks natural, Grade II= Breast is a little firm but looks normal, Grade III=Breast is firm and looks abnormal or Grade IV= Breast is hard, painful, and looks abnormal. The percentage of participants in each Baker Grade is reported.|Interim analysis: 12 months|Full analysis population included all participants.|||percentage of participants|||Number
2654030|NCT01639742|Secondary|Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue|The investigator examined the breasts and evaluated whether the implant was palpably distinguishable from the tissue using a 5-point scale where 1=implant very easy to distinguish from the tissue to 5=implant indistinguishable from the tissue.|6 months|Full analysis population included all participants.|||score on a scale||Standard Deviation|Mean
2654031|NCT01639742|Secondary|Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire|Participants evaluated satisfaction with their breasts using the BREAST-Q. Summary scores were computed by summing the score of each response and transferring them to a 0 (worst) to 100 (best) scale.|6 months|Full analysis population included all participants.|||score on a scale||Standard Deviation|Mean
2654032|NCT01639742|Primary|Investigator Overall Satisfaction With the Device Using a 5-Point Scale|The investigator evaluated the overall satisfaction with the device using a 5-point scale where 1=definitely dissatisfied with the device to 5=definitely satisfied with the device.|3 months|Full analysis population included all participants.|||score on a scale||Standard Deviation|Mean
2654033|NCT01639729|Primary|CST 1/2|time for maximum plasma concentration to decrease by 50%|24 hours|The number of subjects (n) in Treatment D was less than the total 22 subjects for the following PK parameters: CST½ (n=16).|||hours||Full Range|Median
2654034|NCT01639729|Primary|Tmax|time to maximum plasma concentration|24 hours||||hours||Full Range|Median
2654035|NCT01639729|Primary|Cmax|maximum plasma concentration|24 hours||||pg/mL||Standard Deviation|Mean
2654037|NCT01639703|Secondary|Permeability Surface According to Immunohistochemistry Parameter (CD31)|"CD31 is an immunohistochemistry marker of microvessel density. CD31 labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of CD31 labelling, lesions were classified in the CD31 0% category."|Within a week from CT perfusion to surgery|A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions.|||mL/100 grams/min|lesions|Standard Deviation|Mean
2654038|NCT01639703|Secondary|Permeability Surface According to Immunohistochemistry Parameter (Glutamine Synthetase)|"Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.~Glutamine synthetase labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of glutamine synthetase labelling, lesions were classified in the glutamine synthetase 0% category."|Within a week from CT perfusion to surgery|A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions in different groups: 3 patients presented at least 1 lesion in group10-50% and another lesion in group >50%; 2 patients presented at least 1 lesion in group >50% and 1 missing data; 2 patients presented missing data.|||mL/100 grams/min|lesions|Standard Deviation|Mean
2654039|NCT01639703|Secondary|Blood Flow According to Immunohistochemistry Parameter (CD31)|"CD31 is an immunohistochemistry marker of microvessel density. CD31 labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of CD31 labelling, lesions were classified in the CD31 0% category."|Within a week from CT perfusion to surgery|A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions.|||mL/100 grams/min|lesions|Standard Deviation|Mean
2654040|NCT01639703|Secondary|Blood Flow According to Immunohistochemistry Parameter (Glutamine Synthetase)|"Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.~Glutamine synthetase labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of glutamine synthetase labelling, lesions were classified in the glutamine synthetase 0% category."|Within a week from CT perfusion to surgery|A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions in different groups: 3 patients presented at least 1 lesion in group10-50% and another lesion in group >50%; 2 patients presented at least 1 lesion in group >50% and 1 missing data; 2 patients presented missing data.|||mL/100 grams/min|lesions|Standard Deviation|Mean
2654041|NCT01639703|Secondary|Blood Volume According to Immunohistochemistry Parameter (CD31)|"CD31 is an immunohistochemistry marker of microvessel density. CD31 labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of CD31 labelling, lesions were classified in the CD31 0% category."|Within a week from CT perfusion to surgery|A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions.|||mL/100 grams|lesions|Standard Deviation|Mean
2654042|NCT01639703|Secondary|Blood Volume According to Immunohistochemistry Parameter (Glutamine Synthetase)|"Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.~Glutamine synthetase labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of glutamine synthetase labelling, lesions were classified in the glutamine synthetase 0% category."|Within a week from CT perfusion to surgery|A total of 77 patients were analyzed for CT perfusion and immunohistochemistry parameters. A patient could have several lesions in different groups: 3 patients presented at least 1 lesion in group10-50% and another lesion in group >50%; 2 patients presented at least 1 lesion in group >50% and 1 missing data; 2 patients presented missing data.|||mL/100 grams|lesions|Standard Deviation|Mean
2654043|NCT01639703|Secondary|Hepatic Perfusion Index (HPI) According to Degree of Lesions Differentiation|The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."|||percentage|lesions|Standard Deviation|Mean
2654044|NCT01639703|Secondary|Total Liver Perfusion (TLP) According to Degree of Lesions Differentiation|"The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.~TLP = ALP + PVP"|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."|||mL/min/100 mL|lesions|Standard Deviation|Mean
2654045|NCT01639703|Secondary|Portal Venous Liver Perfusion (PVP) According to Degree of Lesions Differentiation|The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."|||mL/min/100 mL|lesions|Standard Deviation|Mean
2654046|NCT01639703|Secondary|Arterial Liver Perfusion (ALP) According to Degree of Lesions Differentiation|The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."|||mL/min/100 mL|lesions|Standard Deviation|Mean
2654062|NCT01639443|Secondary|Advanced Adenoma Detection/Cecal Intubation Rates|The investigators will compare daily advanced adenomatous polyp detection and daily cecal intubation rates between groups.|After 20 months of running study in clinic|We only collected data on polyp detection for the first half of our Fast-tracked participants and all Controls seen over the same time period (4897 in total).|||Number of Polyps Detected per patient||Standard Deviation|Mean
2654047|NCT01639703|Primary|Permeability Surface (PS) According to Degree of Lesions Differentiation|The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."|||mL/100 grams/min|lesions|Standard Deviation|Mean
2654048|NCT01639703|Primary|Blood Flow (BF) According to Degree of Lesions Differentiation|The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."|||mL/100 grams/min|lesions|Standard Deviation|Mean
2654049|NCT01639703|Primary|Blood Volume (BV) According to Degree of Lesions Differentiation|The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.|Within a week from CT perfusion to surgery|"A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as well differentiated, 42 had lesions assessed as moderately/poorly differentiated and 3 had lesions assessed as well differentiated and moderately/poorly differentiated."|||mL/100 grams|lesions|Standard Deviation|Mean
2654050|NCT01639560|Secondary|Prolonged Smoking Outcome at 24 Weeks (End of Study)|To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.|24 weeks||||participants|||Number
2654051|NCT01639560|Secondary|Point Prevalence Smoking Outcome at 24 Weeks (End of Study)|To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers. Point prevalence is defined as no smoking in the past 7 days.|24 weeks||||participants|||Number
2654052|NCT01639560|Primary|Prolonged Smoking Outcome at 12 Weeks (End of Treatment)|To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.|12 weeks||||participants|||Number
2654053|NCT01639560|Primary|Point Prevalence Smoking Outcome at 12 Weeks (End of Treatment)|To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Point prevalence is defined as no smoking in the past 7 days.|12 weeks||||participants|||Number
2654054|NCT01639495|Secondary|Late Onset Serious Adverse Events|Late onset serious adverse events (SAEs) are those non-primary SAEs occurred after 31 days post procedure|From 31 days post procedure to month 12|Safety cohort, including Enrolled subjects who underwent insertion of the study catheter.|||Number of participants|||Number
2654055|NCT01639495|Secondary|Percentage of Subjects Achieved Acute Effectiveness|Acute effectivenesss is defined as confirmation of entrance block into all Pulmonary veins|5 hours of procedure time|Effectiveness cohort, defined as those enrolled subjects who underwent insertion of the study catheter and an AF ablation procedure. Subjects without RF energy delivery will be excluded (i.e. discontinued subjects).|||Percentage of participants||95% Confidence Interval|Number
2654056|NCT01639495|Primary|Incidence of Primary Adverse Events Within Specified Study Period|Primary safety endpoint consists of primary adverse events (AE) within 7 days post procedure Or pulmonary vein stenosis and atrio-esophageal fistula events that occurred within 12 months post-procedure. Primary adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke / cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, initial and prolonged hospitalization (excluding those due to pre-existing arrhythmia recurrence), heart block.|12 months post procedure|144 subjects that had study catheter inserted into their body; INCLUDES study ineligible & untreated subjects|||percentage of subjects with primary AE||95% Confidence Interval|Number
2654057|NCT01639495|Secondary|Peri-procedural Serious Adverse Events|Peri-procedural serious adverse events (SAEs) are those non-primary SAEs occurred within 8-30 days post procedure|Within 8-30 days post procedure|Safety cohort, including Enrolled subjects who underwent insertion of the study catheter.|||Number of participants|||Number
2654058|NCT01639495|Primary|Percentage of Subjects Achieved Freedom From Atrial Tachyarrhythmias|"Freedom from documented symptomatic atrial fibrillation/atrial tachycardia/atrial flutter (hereinafter collectively referred to as atrial tachyarrhythmias) based on electrocardiographic data during the effectiveness evaluation period (Day 91-361). Acute procedure failures, antiarrhythmic drug(AAD) changes and repeat ablation occurring during evaluation period were deemed as primary effectiveness failures"|Day 91-361|137 Study-eligible subjects with per-protocol procedure. CENSORED: 1 lost to follow-up subject without recurrence|||Percentage of participants||95% Confidence Interval|Number
2654059|NCT01639469|Primary|Total Falls During the 1-year Follow-up|Total number of falls over the 1-year follow-up; self-reported falls collected on a weekly basis and totaled over the follow-up period.|up to 1 year|"2 participants not analyzed were excluded due to early loss to follow-up and had no fall data collected."|||Total count of falls|||Number
2654060|NCT01639443|Secondary|Cost Comparisons|For cost comparisons, the investigators will aggregate total provider overtime costs for colonoscopies performed. Cost is reported per day.|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.|||dollars||Standard Deviation|Mean
2654061|NCT01639443|Secondary|Length of Workday|Length of Workday in hours (comparing days with Fast-Tracked Appointments to Control days without)|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.|||hours||Standard Deviation|Mean
2654063|NCT01639443|Secondary|"Daily Service Denials (Bumps)"|The investigators will compare the number of patients bumped per day between scheduling approaches|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.|||participants|||Number
2654064|NCT01639443|Secondary|Scheduling-to-procedure Lag Time|The investigators will calculate the mean daily lag time for all colonoscopy and upper endoscopies performed per day|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.|||days||Standard Deviation|Mean
2654065|NCT01639443|Primary|Percentage of GI Clinic Capacity Filled|Investigators' primary objective will be to evaluate the impact of no-show predictive overbooking on percentage of the GI endoscopy clinic that are filled on a given day. Days where at least one Fast-tracked patient attended an appointment were compared to days where only Control patients attended appointments. Percentage of GI Clinic Capacity is calculated as the number of appointments completed divided by number of appointment spots available on a given day. This percentage was compared between Fast-tracked days and Control days, using data from 1672 patients.|After 12 months of running study in clinic|These 1672 patients are a subset of all patients who were enrolled in this study. We dropped data on a first wave of participants (69 Fast-tracked and 3294 Controls) because of problems incorporating recruitment strategy into clinic. However, data from these individuals was used to build predictive model.|||percentage of clinic capacity filled||Standard Deviation|Mean
2654066|NCT01639352|Secondary|Toxicity Profile of Protocol Therapy|Number of patients experiencing adverse events and/or toxicities while receiving protocol therapy.|Up to 2 Years||||Participants|||Count of Participants
2654067|NCT01639352|Secondary|Duration of Overall Response|Duration of Overall Response in participants achieving complete response (CR) or partial response (PR) to SOM230 treatment. The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Overall response is assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by MRI or CT Scan. CR is defined as disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Up to 2 Years|No participants achieved complete response (CR) or partial response (PR) to protocol therapy.||||||
2654068|NCT01639352|Secondary|Overall Response Rate (ORR)|Proportion of patients achieving Complete Response and Partial Response (CR+PR) to protocol therapy per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT Scan. CR is defined as disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Up to 2 Years||||Participants|||Count of Participants
2654069|NCT01639352|Secondary|Rate of Overall Survival (OS)|Rate of Overall Survival (OS) in participants receiving protocol therapy. OS will be measured from the date of enrollment to the date of death or last contact.|From Enrollment Until Study Completion, Approximately 3 Years||||months||95% Confidence Interval|Median
2654070|NCT01639352|Secondary|Rate of Progression-Free Survival (PFS):|Rate of Progression-Free Survival (PFS). PFS will be measured from the date of enrollment to the earliest date of documented disease progression or death from any cause, whichever is earlier. Progression is defined according to RECIST v 1.1 criteria as an at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who remain alive without progression, follow up time will be censored at the date of last disease assessment.|From Enrollment Until Study Completion, Approximately 3 Years||||months||95% Confidence Interval|Median
2654071|NCT01639352|Primary|Disease Control Rate (DCR)|The disease-control rate (DCR) is defined as the proportion of participants achieving a best overall response of complete response (CR), partial response or stable disease (SD) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by MRI or CT Scan, and that is maintained for at least 8 weeks. CR is defined as disappearance of all target lesions; PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|At least 2 cycles, about 8 weeks||||Participants|||Count of Participants
2654072|NCT01639222|Secondary|Amount of Calcium Excreted in Urine From 0 to 6 Hours Post Dose Corected for Creatinine (Ae0-6h/Creatinine)|To account for potential inaccuracies in urine collection, creatinine correction of calcium excretion was also assessed. Ca2+ Ae0-6h/Creatinine was obtained by dividing the urinary concentration of calcium by the urinary creatinine concentration.|Day 3 of Period 1 (Baseline) and Day 3 in Period 2. Samples will be taken 0-6 Hours postdose|PK/PD set|||liters||Standard Deviation|Mean
2654073|NCT01639222|Primary|Area Under the Curve From 0 to 6 Hours Post Dose of Parathyroid Hormone (PTH AUC0-6h) in Serum|The area under the curve from 0 to 6 hours post dose of parathyroid hormone (PTH AUC0-6h) in serum, calculated using the linear trapezoidal formula.|Day 3 in Period 1 (Reference) and Day 3 in Period 2. Samples were taken at predose, 0.5, 1, 2, 3, 4, and 6 hour post dose.|PK/PD set|||h*pg/mL||Standard Deviation|Mean
2654074|NCT01639222|Primary|Amount of Calcium Excreted in Urine From 0 Hours up to 6 Hours Post Dose (Ca2+ Ae0-6h)|Ca2+ Ae0-6h was calculated as the urine volume of the urine collected from 0 to 6 hours multiplied by the calcium concentration measured in urine.|Day 3 of Period 1 (Reference) and Day 3 in Period 2. Samples were taken 0-6 Hours post dose|The Pharmacokinetic/Pharmacodynamic (PK/PD) Set included all enrolled subjects who received at least one dose of the mock treatment who had reliable values of either the primary PK parameter Ca2+ Ae0-6h in both periods or the primary PD parameter PTH AUC0-6h in both periods.|||mmol||Standard Deviation|Mean
2654075|NCT01639157|Secondary|Peak Heart Rate|Heart rate was measured with an automated monitor. Higher values represent greater heart rate. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||beats per minute||Standard Error|Mean
2654076|NCT01639157|Secondary|Peak Diastolic Blood Pressure|Diastolic blood pressure was measured with an automated monitor. Higher values represent greater diastolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||mmHg||Standard Error|Mean
2654077|NCT01639157|Secondary|Peak Oral Temperature|Oral temperature was measured with an automated monitor. Higher values represent greater temperature. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||Degrees Fahrenheit||Standard Error|Mean
2654078|NCT01639157|Secondary|"Peak Ratings of Talkative, Friendly on the Visual Analog Scale"|"Subjects rated their feelings of Talkative, Friendly on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2654079|NCT01639157|Secondary|"Peak Ratings of Willing to Take Again on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Take Again on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2654080|NCT01639157|Secondary|"Peak Ratings of Stimulated on the Visual Analog Scale"|"Subjects rated their feelings of Stimulated on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2654081|NCT01639157|Secondary|"Peak Ratings of Sluggish, Fatigued, Lazy on the Visual Analog Scale"|"Subjects rated their feelings of Sluggish, Fatigued, Lazy on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2654082|NCT01639157|Secondary|"Peak Ratings of Shaky, Jittery on the Visual Analog Scale"|"Subjects rated their feelings of Shaky, Jittery on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2654083|NCT01639157|Secondary|"Peak Ratings of Rush on the Visual Analog Scale"|"Subjects rated their feelings of Rush on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2654084|NCT01639157|Secondary|"Peak Ratings of Restless on the Visual Analog Scale"|"Subjects rated their feelings of Restless on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2654085|NCT01639157|Secondary|"Peak Ratings of Performance Improved on the Visual Analog Scale"|"Subjects rated their feelings of Performance Improved on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2654086|NCT01639157|Secondary|"Peak Ratings of Performance Impaired on the Visual Analog Scale"|"Subjects rated their feelings of Performance Impaired on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2663484|NCT01552213|Secondary|Number of Participants With Neonatal Hyperbilirubinemia|Neonates treated for hyperbilirubinemia|1 week after delivery|Participants with available data included in the analysis.|||Participants|||Count of Participants
2654087|NCT01639157|Secondary|"Peak Ratings of Willing to Pay For on the Visual Analog Scale"|"Subjects rated their feelings of Willing to Pay For on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2654088|NCT01639157|Secondary|"Peak Ratings of Nervous, Anxious on the Visual Analog Scale"|"Subjects rated their feelings of Nervous, Anxious on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2654089|NCT01639157|Secondary|"Peak Ratings of Nauseated, Queasy, Sick to Stomach on the Visual Analog Scale"|"Subjects rated their feelings of Nauseated, Queasy, Sick to Stomach on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2654090|NCT01639157|Secondary|"Peak Ratings of Like Drug on the Visual Analog Scale"|"Subjects rated their feelings of Like Drug on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2654091|NCT01639157|Secondary|"Peak Ratings of Irregular/Racing Heartbeat on the Visual Analog Scale"|"Subjects rated their feelings of Irregular/Racing Heartbeat on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2654092|NCT01639157|Secondary|"Peak Ratings of High on the Visual Analog Scale"|"Subjects rated their feelings of High on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2654093|NCT01639157|Secondary|"Peak Ratings of Good Effects on the Visual Analog Scale"|"Subjects rated their feelings of Good Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2654094|NCT01639157|Secondary|"Peak Ratings of Euphoric on the Visual Analog Scale"|"Subjects rated their feelings of Euphoric on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2654095|NCT01639157|Secondary|"Peak Ratings of Bad Effects on the Visual Analog Scale"|"Subjects rated their feelings of Bad Effects on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2654096|NCT01639157|Secondary|"Peak Ratings of Any Effect on the Visual Analog Scale"|"Subjects rated their feelings of Any Effect on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2654097|NCT01639157|Secondary|"Peak Ratings of Active, Alert, Energetic on the Visual Analog Scale"|"Subjects rated their feelings of Active, Alert, Energetic on a Visual Analog Scale. This item was rated from 0 (minimum)-100 (maximum) on a Visual Analog Scale. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitary units on a Visual Analog Scale||Standard Error|Mean
2654166|NCT01638507|Primary|Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI)||12 months|The primary analysis set was the Intent-To-Treat (ITT) population, defined as all patients who signed the written informed consent and were enrolled in the study.|||percentage of participants||95% Confidence Interval|Number
2654098|NCT01639157|Secondary|Peak Score on Stimulant Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Stimulant Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Stimulant Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitrary units on a Likert-type scale||Standard Error|Mean
2654099|NCT01639157|Secondary|Peak Systolic Blood Pressure|Systolic blood pressure was measured with an automated monitor. Higher values represent greater systolic pressure. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions.|This measure was completed at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||mmHg||Standard Error|Mean
2654100|NCT01639157|Secondary|Peak Score on Sedative Subscale of the Adjective Rating Scale|"Subjects completed 16 items that loaded into the Sedative Subscale of the Adjective Rating Scale. The items were rated 0-4 on a Likert-type scale and the sum for the 16 sedative items was summed to yield the Sedative Subscale score. The maximum score for this scale was 64, the minimum was 0. Higher values represent greater subjective effects on this item. Peak scores were calculated from multiple assessments for each cocaine dose under both buspirone and placebo conditions."|Subjects completed this measure at 15 minute intervals for 45 minutes after sampling each cocaine dose under both buspirone and placebo maintenance conditions.||||arbitrary units on a Likert-type scale||Standard Error|Mean
2654101|NCT01639157|Primary|Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative|The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Stoops et al., 2010) in which subjects made 6 choices between available each available cocaine dose and money (US$0.25). Reinforcing effects are measured for each cocaine dose during both buspirone and placebo maintenance.|One test per cocaine dose level per intervention for each participant over his/her 2 week inpatient admission||||Number of Cocaine Choices||Standard Error|Mean
2654102|NCT01639144|Primary|Postoperative Infection and Delayed Wound Healing.|Postoperative deep incisional surgical site infection and delayed wound healing (lack of primary healing of skin edges typically with wound secretion).|Infection: 30 days after surgery. Delayed wound healing: 60 days.|Patients have foot and/or ankle surgery.|||participants|||Number
2654103|NCT01639040|Other Pre-specified|Percent Change in Eczema Area and Severity Index (EASI) Score From Day 1 (Baseline) to Day 29 (Week 4) - Censored LOCF|EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. The efficacy data were set to missing after prohibited medication was used or after the participant was discontinued from the study. Then, all missing values were imputed by simple LOCF.|Baseline up to Day 29|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline assessment; it was based on the treatment allocated (as randomized).|||percent Change||Standard Deviation|Mean
2654104|NCT01639040|Other Pre-specified|Percent Change in Investigator's Global Assessment (IGA) Score From Day 1 (Baseline) to Day 29 (Week 4) - Censored LOCF|IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). The efficacy data were set to missing after prohibited medication was used or after the participant was discontinued from the study. Then, all missing values were imputed by simple LOCF.|Baseline up to Day 29|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline assessment; it was based on the treatment allocated (as randomized).|||percent change||Standard Deviation|Mean
2654105|NCT01639040|Other Pre-specified|"Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 or 1 at Day 29"|IGA was an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear).|Day 29|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline assessment; it was based on the treatment allocated (as randomized).|||percentage of participants||95% Confidence Interval|Number
2654106|NCT01639040|Other Pre-specified|Percent Change in Pruritus Numerical Rating Scale (NRS) From Day 1 (Baseline) to Day 29 (Week 4)|Pruritus NRS was an assessment tool that was used to report the intensity of participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]).|Baseline up to Day 29|FAS included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline assessment; it was based on the treatment allocated (as randomized).|||percent change||Standard Deviation|Mean
2654107|NCT01639040|Other Pre-specified|Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Score: Reduction of ≥50 at Day 29 - Censored Last Observation Carried Forward (LOCF)|The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. The efficacy data were set to missing after prohibited medication was used or after the participant was discontinued from the study. Then, all missing values were imputed by simple LOCF.|Day 29|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication and had at least 1 post-baseline assessment; it was based on the treatment allocated (as randomized).|||percentage of participants||95% Confidence Interval|Number
2665300|NCT01535014|Primary|Percentage of Subjects Who Lose at Least 5 Percent of Baseline Body Weight After 24 Weeks of Treatment Weeks of Treatment||assessed after 24 weeks of treatment|Intention to treat|||percentage of participants|||Number
2654108|NCT01639040|Primary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)|Any untoward medical occurrence in a subject who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (from start of administration of first dose of study drug to the end of study [up to Day 78]). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Baseline up to the end of study (up to Day 78)|Safety population included all randomized participants who received any study drug; based on the treatment received (as treated).|||percentage of participants|||Number
2654109|NCT01639001|Secondary|Percentage of Participants With Treatment-emergent AEs (Treatment Related)|An AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were to be collected from first dose until 28 days after the last dose of study medication. SAEs could be collected after this timeframe if considered to be treatment related. Grade 3 and 4 AEs in the below table indicated severe AE and life-threatening consequences respectively; Grade 5 indicated death related to AE. Chemotherapy group in the below table, only includes data before crossover to crizotinib for those participants who crossed over to receive crizotinib treatment.|From the first dose of study medication until 28 days after the last dose of study medication. However all AEs entered in the database from the treatment start were included in AE analyses (assessed up to 33 months)|All randomized participants who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.|||Percentage of participants|||Number
2654110|NCT01639001|Secondary|Percentage of Participants With Treatment-emergent Adverse Events (AEs; All Causalities)|An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. AEs were to be collected from first dose until 28 days after the last dose of study medication. SAEs could be collected after this timeframe if considered to be treatment related. Grade 3 and 4 AEs in below table indicated severe AE and life-threatening consequences respectively; Grade 5 indicated death due to AE. Chemotherapy group in the below table includes data before crossover to crizotinib for participants who crossed over to receive crizotinib.|From the first dose of study medication until 28 days after the last dose of study medication. However all AEs entered in the database from the treatment start were included in AE analyses (assessed up to 33 months)|All randomized participants who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.|||Percentage of participants|||Number
2654111|NCT01639001|Secondary|Agreement Between Central Laboratory ALK FISH and ALK IHC Test Results - Molecular Profiling Evaluable|Agreement between central laboratory anaplastic lymphoma kinase (ALK) fluorescence in situ hybridization (FISH) and ALK immunohistochemistry (IHC) test results is based on analysis of participants in the Molecular Profiling (MP) evaluable population that have an ALK IHC result and an ALK FISH result of either positive or negative only. This MP evaluable population included participants who screen failed, which their ALK test results were negative based on FISH test. Tumor tissue samples from these screen failure participants were consented and kept. These samples served as a part of negative sample set for evaluation of IHC test and/or polymerase chain reaction (PCR) to determine ALK fusion events. Participants with FISH results of uninformative and assay not performed and IHC results of valid IHC status not available were excluded from the analysis of agreement between central laboratory ALK FISH and ALK IHC test results.|Screening, less than or equal to 28 days prior to dosing.|The MP evaluable population included 812 participants, of which there were 771 participants that had a test result (positive or negative) from both the FISH test and the IHC test.|||Number of participants|||Number
2654112|NCT01639001|Secondary|Percentage of Participants With Visual Disturbance as Assessed by Visual Symptom Assessment Questionnaire (VSAQ-ALK)|"The participants who responded to the question: Have you experienced any visual disturbances? Only the participants who answered yes were instructed to complete the rest of the questionnaire. N was the number of participants who had completed the first question."|Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.|||Percentage of participants|||Number
2654113|NCT01639001|Secondary|Change From Baseline in General Health Status as Assessed by EQ-5D- Index|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a visual analog scale (VAS). EQ-5D summary index is obtained with a formula that weights each level of the 5 dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).|Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.|||Units on a scale||95% Confidence Interval|Mean
2654155|NCT01638546|Secondary|Overall Response (ORR) by RECIST 1.1 Criteria|Corresponding exact two-sided 95% confidence intervals will be calculated and reported in both arms of the study. Comparisons between treatment arms will be performed using Fisher-exact test.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 4 months||||participants|||Number
2665363|NCT01534208|Primary|Change From Baseline in BMI|Mean change from baseline in BMI at end of treatment (26 weeks)|6 months|ITT|||kg/m2||Standard Deviation|Mean
2654114|NCT01639001|Secondary|Change From Baseline in General Health Status as Assessed by EuroQol 5D (EQ-5D)- Visual Analog Scale (VAS)|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a visual analog scale (VAS). The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.|Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.|||Units on a scale||95% Confidence Interval|Mean
2654115|NCT01639001|Secondary|Change From Baseline in Lung Cancer Symptom Scores as Assessed by the EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13)|The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. The QLQ-LC13 Alopecia, Coughing, Dysphagia, Dyspnoea, Haemoptysis, Pain in arm or shoulder, Pain in chest, Pain in other parts, Peripheral neuropathy, and Sore mouth each ranged from 0-100 with higher scores indicating a high level of symptomatology/problems.|Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.|||Units on a scale||95% Confidence Interval|Mean
2654116|NCT01639001|Secondary|Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The QLQ-C30 Appetite loss, Constipation, Diarrhea, Dysponea, Fatigue, Financial difficulties, Insomnia, Nausea/vomiting, and Pain each ranged from 0-100 with higher scores indicating a high level of symptomatology/problems.|Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.|||Units on a scale||95% Confidence Interval|Mean
2654117|NCT01639001|Secondary|Change From Baseline in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The QLQ-C30 Global QOL, Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, and Social Functioning each ranged from 0-100 with higher scores indicating a better level of functioning or better quality of life.|Cycle 1 Day 1 to end of treatment or withdrawal, no later than 4 weeks (+/- 1 week) from last dose of study medication or when the decision was taken to withdraw from the study (whichever was sooner, assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.|||Units on a scale||95% Confidence Interval|Mean
2654118|NCT01639001|Secondary|Time to Deterioration (TTD) in Participant Reported Pain, Dyspnea, or Cough|TTD in pain in chest, dyspnea, or cough from the Quality of Life Questionnaire Supplement Module for Lung Cancer (QLQ-LC13) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the 3 symptoms.|From Baseline to deterioration while on study treatment. For participants with no deterioration, the data was censored at the last date when QLQ-LC13 assessment for pain, dyspnea, or cough was completed (assessed up to 33 months)|Participants from the safety analysis population who completed a baseline and at least 1 post-baseline PRO assessment.|||Months||95% Confidence Interval|Median
2654119|NCT01639001|Secondary|Extracranial Time To Progression (EC-TTP) Based on IRR|EC-TTP was defined similarly to TTP, but only considering extracranial disease (excluding intracranial disease) and the progression was determined based on either new extracranial lesions or progression of existing extracranial lesions.|Randomization to objective extracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||Months||95% Confidence Interval|Median
2654120|NCT01639001|Secondary|Intracranial Time To Progression (IC-TTP) Based on IRR|IC-TTP was defined similarly to TTP, but only considering intracranial disease (excluding extracranial disease) and the progression was determined based on either new brain metastases or progression of existing brain metastases.|Randomization to objective intracranial progression or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||Months||95% Confidence Interval|Median
2654121|NCT01639001|Secondary|Time To Progression (TTP) Based on IRR|TTP was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression, as determined by IRR. If tumor progression data included more than 1 date, the first date was used. TTP (in months) was calculated as (first event date − randomization date +1)/30.44.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||Months||95% Confidence Interval|Median
2654156|NCT01638546|Primary|Progression-free Survival, Calculated as the Proportion of Patients Alive and Without Evidence of Disease|Compared across the two arms using a Fisher exact test.|From randomization to time of progression or death, whichever occurs first, assessed at 4 months||||participants|||Number
2654157|NCT01638507|Secondary|Clinical Endpoint: Bleeding Complications in General||12 months||||percentage of bleeding complications|||Number
2654122|NCT01639001|Secondary|Time to Tumor Response (TTR) Based on IRR|TTR was defined as the time from randomization to first documentation of objective tumor response (CR or PR) as determined by the IRR. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response. TTR was calculated for the subgroup of participants with objective tumor response.|Randomization to first documentation of objective tumor response (assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. N=Participants who had objective tumor response by IRR.|||Weeks||Full Range|Median
2654123|NCT01639001|Secondary|Duration of Response (DR) Based on IRR|DR was defined as the time from the first documentation of objective tumor response (CR or PR), as determined by the IRR, to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR (in weeks) was calculated as (first date of PD or death − first date of CR or PR +1)/7. DR was only calculated for the subgroup of participants with an objective tumor response.|From objective response to date of progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization. N = Participants with objective tumor response by IRR.|||Weeks||95% Confidence Interval|Median
2654124|NCT01639001|Secondary|Estimate of the Percentage of Participants Surviving at 1 Year and at 18 Months|Probability of survival 1 year and 18 month after randomization. The probability of survival at 1 year was estimated using the Kaplan Meier method and a 2-sided 95% CI for the log [-log(1-year survival probability)] was calculated using a normal approximation and then back transformed to give a CI for the 1-year survival probability itself. The probability of survival at 18 months was estimated similarly.|From randomization to 18 months|The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||Percentage of paricipants||95% Confidence Interval|Number
2654125|NCT01639001|Secondary|Percentage of Participants With Disease Control at 12 Weeks Based on IRR|Disease Control Rate (DCR) at 12 weeks is defined as the percent of participants with CR, PR or stable disease (SD) at 12 weeks according to RECIST version 1.1 as determined by the IRR. The best response of SD can be assigned if SD criteria were met at least once after randomization at a minimum interval of 6 weeks. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|From randomization to Week 12|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||Percentage of participants||95% Confidence Interval|Number
2654126|NCT01639001|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death due to any cause. OS (in months) was calculated as (date of death − date of randomization +1)/30.44.|From randomization to death or last date known alive for those not known to have died (whichever occurred first, assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||Months||95% Confidence Interval|Median
2654127|NCT01639001|Secondary|Objective Response Rate (ORR) - Percentage of Participants With Objective Response Based on IRR|Percentage of participants with objective response of complete response (CR) or partial response (PR) according to RECIST version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions and disappearance of all non-target lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (assessed up to 33 months)|FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||Percentage of participants||95% Confidence Interval|Number
2654128|NCT01639001|Primary|Progression-Free Survival (PFS) Based on IRR by Treatment Arm|PFS was defined as the time from the date of randomization to the date of the first documentation of objective tumor progression (by IRR) or death on study due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS (in months) was calculated as (first event date − randomization date +1)/30.44. Progression is defined using RECIST v1.1, as at least a 20% increase (including an absolute increase of at least 5 millimeters) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.|Randomization to objective progression, death or last tumor assessment without progression before any additional anti-cancer therapy (whichever occurred first, assessed up to 33 months)|The Full Analysis (FA) population included all participants who were randomized with study treatment assignment designated according to the initial randomization.|||Months||95% Confidence Interval|Median
2654129|NCT01638819|Secondary|Change in Knowledge and Fluid Reasoning (Scaled Score, Range 1-19 for Each Subtest)|The Stanford Binet, version 5, was used to assess the brain function. It can assess the level of intelligence across several age spans and ability levels. The Stanford-Binet looks at intelligence in five areas. In this study 2 areas were looked at: Knowledge and Fluid Reasoning that were age and condition appropriate. Each sub-test has a mean of 10 and a standard deviation of 3. The standard deviation indicates how far above or below the norm the subject's score is. Scores of 7 to 13 are considered to be within the average range of functioning.|Baseline and 6 months|Please note that endpoints for only the first 24 weeks were recorded due to the fact that the placebo second group may not be a true placebo group (stem cell infusion does not necessarily wash out like a drug).|||units on a scale||Standard Deviation|Mean
2654158|NCT01638507|Secondary|Clinical Endpoint: Stroke||12 months||||percentage of strokes|||Number
2654159|NCT01638507|Secondary|Clinical Endpoint: ST||12 months||||percentage of ST|||Number
2654130|NCT01638819|Secondary|Change in Behavior/Learning (Standard Score, Range 40 - 160 for Each Subtest)|"Change in the Vineland Adaptive Behavior and Socialization Scales (2nd edition) between baseline and six months after infusion of AUCB containing stem cells.~Vineland Adaptive Behavior and Socialization Scales consist of the following subparts: Daily Living Skills, Socialization, and Adaptive Behavior Composite (ABC). These are questionnaires completed by a parent or caregiver. Scores above 80 are classified using approximately the same ranges as IQ tests. Scores below 80 are categorized as borderline adaptive functioning (70-80); mildly deficient adaptive functioning (51-69); moderately deficient adaptive behavior (36-50); severely deficient adaptive behavior; (20-35); and markedly or profoundly deficient adaptive behavior (<20)."|Baseline and 6 months|Please note that endpoints for only the first 24 weeks were recorded due to the fact that the placebo second group may not be a true placebo group (stem cell infusion does not necessarily wash out like a drug).|||units on a scale||Standard Deviation|Mean
2654131|NCT01638819|Primary|Change in Language (Total Standard Score, Range 40 - 160)|"Change in language as measured by the Receptive One-Word Vocabulary Test (ROWVT-4) and Expressive One-Word Vocabulary Test (EOWVT-4) at baseline and six months following infusion of stem cells from AUCB or infusion of placebo.~The ROWPVT-4 and EOWPVT-4 were administered by a neuropsychologist and are norm-referenced assessments. The ROWPVT-4 tests an individual's ability to match a spoken word with an image of an object, action, or concept. The EOWPVT-4 tests an individual's ability to name, with one word, objects, actions, and concepts when presented with color illustrations. The tests target the ability to understand the meaning of words spoken and name what is depicted on a test plate without context.~Scores of 85-115 are considered to be within the average range of functioning."|Baseline and 6 months|Please note that endpoints for only the first 24 weeks were recorded due to the fact that the placebo second group may not be a true placebo group (stem cell infusion does not necessarily wash out like a drug).|||units on a scale||Standard Deviation|Mean
2654132|NCT01638559|Secondary|Change in Child Health Related Quality of Life Scores Between Tolerant and Non-tolerant Subjects|Health related quality of life was measured by the PedsQL 4.0 Generic Core scale, the Multidimensional Fatigue scale, and the PedsQL 3.0 Transplant module. Change was calculated as the difference between the questionnaire completed at the initiation of withdrawal and at month 36 for the total generic score, the total fatigue score, and total transplant score. This change was calculated separately for tolerant and non-tolerant subjects. Each score ranges from 0-100, with a higher score indicating a better quality of life.|Time from immunosuppression withdrawal through a minimum of 36 months and maximum of 48 months of follow-up|Intent-to-Treat|||Quality of Life Scores on a Scale||95% Confidence Interval|Mean
2654133|NCT01638559|Secondary|Change in Immunosuppression Medication Dose From Study Initiation of Withdrawal to the End of the Study|Change of immunosuppression (IS) dose from baseline to end of study for all participants not deemed tolerant by the trial definition either due to discontinuing IS withdrawal or completing withdrawal but not meeting the criteria for tolerance on the primary endpoint biopsy assessment.|Time from immunosuppression withdrawal through a minimum of 36 months and maximum of 48 months of follow-up|Intent-to-Treat participants who were not operationally tolerant and who remained on the same medication throughout the study. Three subjects that were not operationally tolerant converted to alternate immunosuppression medications.|||percentage of dose||95% Confidence Interval|Mean
2654134|NCT01638559|Secondary|Change in Immunosuppression Medication (Calcineurin Inhibitor) Dose From Start of Immunosuppression Withdrawal to the Time of Immunosuppression Withdrawal Failure|The mean percent of immunosuppression (IS) dose reduction from baseline to the time of immunosuppression withdrawal failure. Immunosuppression withdrawal failure is defined as any incidence of increasing immunosuppression medications instead of completing withdrawal.|Time from starting immunosuppression withdrawal until immunosuppression withdrawal failure, maximum 52 weeks|Intent-to-Treat who failed immunosuppression withdrawal|||percentage of dose||95% Confidence Interval|Mean
2654135|NCT01638559|Secondary|Duration of Operational Tolerance|Median participant duration of operational tolerance. Duration of operational tolerance is defined as the number of days that participants are not taking immunosuppression medications.|Time from immunosuppression withdrawal through a minimum of 36 months and a maximum of 48 months of follow-up|Participants that Completed Withdrawal and were Operationally Tolerant|||days||95% Confidence Interval|Median
2654136|NCT01638559|Secondary|Impact of Immunosuppression Withdrawal (ISW) on Allograft Histology|"The impact of ISW on allograft fibrosis using the Ishak scoring system to measure the change in fibrosis from the screening liver biopsy to the end-of-study (month-48) liver biopsy.~In the Ishak histologic scoring system, the higher the score/stage, the more fibrosis: Scores range from 0 to 6, with 6 representing the most fibrosis: 0=No fibrosis; 1=Fibrous expansion of some portal areas, with or without short fibrous septa; 2=Fibrous expansion of most portal areas, with or without short fibrous septa; 3=Fibrous expansion of most portal areas, with occasional portal to portal bridging; 4=Fibrous expansion of portal areas with marked bridging (portal to portal) as well as portal to central; 5=Marked bridging (portal to portal and/or portal to central) with occasional nodules (incomplete cirrhosis); and 6=Cirrhosis, probable or definite.~Decrease in score from screening (baseline) indicates improvement"|Time from screening biopsy to end of study (month 48) biopsy|"Intent-to-Treat~-Of the original 88 participants, 3 participants did not finish the study and 1 participant did not complete the final liver biopsy."|||Participants|||Count of Participants
2654137|NCT01638559|Secondary|Reason for Discontinuation of Withdrawal|Reasons participants discontinued immunosuppression withdrawal, such as Biopsy Proven Acute Rejection, Chronic Rejection, Clinical Rejection, Death, Pregnancy, etc.). Only the root cause for discontinuation for each subject is presented in these results if multiple events led to discontinuation of immunosuppression withdrawal.|Time from start of immunosuppression withdrawal through discontinuation of withdrawal, a maximum of 52 weeks|Participants who failed immunosuppression withdrawal.|||Participants|||Count of Participants
2654160|NCT01638507|Secondary|Clinical Endpoint: MI||12 months||||percentage of MIs|||Number
2654161|NCT01638507|Secondary|Clinical Endpoint: TVR||12 months||||percentage of TVR|||Number
2654162|NCT01638507|Secondary|Clinical Endpoint: TLR||12 months||||percentage of TLR|||Number
2654163|NCT01638507|Secondary|Dual Antiplatelet Therapy (DAPT) Compliance||12 months||||percentage of compliance|||Number
2654164|NCT01638507|Secondary|Clinical Endpoint: Death||12 months||||percentage of death|||Number
2654138|NCT01638559|Secondary|Clinical Severity of Acute Rejection|"The clinical severity of acute rejection was descriptively analyzed using hierarchical categories, as follows:~Dose increase: Increase in IS dose and/or frequency but to a level less than the regimen at study entry, prior to initiating ISW~Reinstitution: Returning to the regimen at study entry, prior to ISW~Intensification: Increased IS dose compared with the dose at study entry, prior to ISW~Conversion: Change to different IS drug~Addition: Initiation of a second IS drug;~Corticosteroids: Administration of any intravenous or oral corticosteroids~Antibody (Ab) treatment: Administration of any rabbit thymoglobulin; usually with corticosteroids"|Time from immunosuppression withdrawal through a minimum of 36 months and maximum of 48 months of follow-up|Participants who experienced rejection (biopsy-proven or clinical)|||Proportion||95% Confidence Interval|Number
2654139|NCT01638559|Secondary|Number and Severity of Biopsies Read as Histologic Acute Rejection|"Number of biopsies that were diagnosed as histologic acute rejection in participants who initiated immunosuppression withdrawal by severity of rejection episode. Rejection severity (mild, moderate, severe) is based on the Banff global assessment grade according to the central pathology reading of the liver biopsy. Mild severity criteria: rejection infiltrate in a minority of triads that is generally mild and confined within the portal spaces. Moderate rejection criteria: rejection infiltrate expanding most or all of the triads. Severe rejection criteria: rejection infiltrate expanding most or all of the triads with spillover into periportal areas and moderate to severe perivenular inflammation that extends into the hepatic parenchyma and is associated with perivenular hepatocyte necrosis.~BPAR: biopsy-proven acute rejection."|Time from immunosuppression withdrawal through a minimum of 36 months and maximum of 48 months of follow-up|Intent-to-Treat|||Biopsies Diagnosed as BPAR|||Number
2654140|NCT01638559|Secondary|Time to Resolution of Rejection|The median time (in weeks) from biopsy proven rejection to resolution of rejection defined as both liver function tests Alanine Aminotransferase (ALT) and Gamma-Glutamyl Transferase (GGT) returning to ≤ 1.5 the baseline values.|Time from immunosuppression withdrawal through a minimum of 36 months and maximum of 48 months of follow-up|Intent-to-Treat|||Weeks||95% Confidence Interval|Median
2654141|NCT01638559|Secondary|Time to Increased Immunosuppression or Re-Initiation of Immunosuppression|The median time (in days) from start of withdrawal from immunosuppression drugs to increasing or re-starting immunosuppression.|Time from immunosuppression withdrawal through a minimum of 36 months and maximum of 48 months of follow-up|Participants that either restarted immunosuppression or increased their dose of immunosuppression|||days||95% Confidence Interval|Median
2654142|NCT01638559|Secondary|Number of Participants With Clinical Complications Usually Attributed to Immunosuppression|This composite endpoint is comprised of clinical complications related to immunosuppression withdrawal and is defined as the occurrence of any of the following: death or graft loss, histologic evidence of refractory acute rejection or biopsy confirmed chronic rejection (CR).|Time from immunosuppression withdrawal through a minimum of 36 months and a maximum of 48 months of follow-up|Intent-to-Treat|||Participants|||Count of Participants
2654143|NCT01638559|Primary|Number of Operationally Tolerant Participants|Number of participants that are operationally tolerant, defined as those who successfully withdraw from immunosuppression and maintain normal allograft status as assessed by liver biopsy and liver tests 12 months after complete immunosuppression withdrawal.|12 Months after complete immunosuppression withdrawal|Intent-to-Treat|||Participants|||Count of Participants
2654144|NCT01638546|Other Pre-specified|RAD51 Expression, Assessed by Immunohistochemistry|Fisher's exact test will be used to correlate response and log-rank test to correlate with progression free survival and overall survival.|Up to 5 years|||||||
2654145|NCT01638546|Other Pre-specified|PTEN Expression, Assessed by Immunohistochemistry|Fisher's exact test will be used to correlate response and log-rank test to correlate with progression free survival and overall survival.|Up to 5 years|||||||
2654146|NCT01638546|Other Pre-specified|Presence of MGMT Promoter Methylation, Assessed by the EpiTyper Assay|Results will be expressed as binary variables. Associations with objective response, with progression free survival and with overall survival will be tested using Fisher's exact test and log-rank test, respectively.|Up to 5 years|||||||
2654147|NCT01638546|Other Pre-specified|PARP-1 Expression|Fisher's exact test will be used to correlate response and log-rank test to correlate with progression free survival and overall survival.|Up to 5 years|||||||
2654148|NCT01638546|Other Pre-specified|Number of Circulating Tumor Cells|The number of CTCs will be correlated with PFS and OS using Cox proportional hazards model. The change in CTCs will be correlated with radiographic response. The number of CTCs at baseline will be correlated with patient characteristics (disease burden, location of metastases, and progression at existing sites or new sites of disease). The number of CTC will be explored as a continuous variable and the presence of a threshold predictive of the outcome will be investigated.|Up to 5 years|||||||
2654149|NCT01638546|Other Pre-specified|MGMT Expression, Assessed by Immunohistochemistry|Results will be expressed as binary variables. Associations with objective response, with progression free survival and with overall survival will be tested using Fisher's exact test and log-rank test, respectively.|Up to 5 years|||||||
2654150|NCT01638546|Other Pre-specified|GammaH2AX Levels|Wilcoxon test will be used to compare the percentage increase of gammaH2AX positive cells between the two treatment groups.|Up to 5 years|||||||
2654151|NCT01638546|Other Pre-specified|Changes in Plasma Markers|Correlated with outcome in the two treatment arms.|Baseline to up to 5 years|||||||
2654152|NCT01638546|Other Pre-specified|BRCA1 Expression, Assessed by Immunohistochemistry|Fisher's exact test will be used to correlate response and log-rank test to correlate with progression free survival and overall survival.|Up to 5 years|||||||
2654153|NCT01638546|Secondary|Number of Participants With Adverse Events|Tabulated According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0. Summary level.|From the start of treatment until 30 days from coming off treatment||||Participants|||Count of Participants
2654154|NCT01638546|Secondary|Overall Survival|Estimated in each treatment group using Kaplan-Meier method. Group comparisons will be performed using log-rank test.|From randomization to time of death||||months||95% Confidence Interval|Median
2654165|NCT01638507|Secondary|Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI||12 months||||percentage of composite|||Number
2654167|NCT01638468|Secondary|Procedure Related Adverse Event Rate|Number of procedure related adverse events occurring within 3 months of the index procedure|3 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint|||events|||Number
2654168|NCT01638468|Secondary|Vasopressor Support|Percentage of participants receiving vasopressor support during the index procedure. Vasopressor support are medications administered to prevent the narrowing of blood vessels.|Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint|||percentage of participants|||Number
2654169|NCT01638468|Secondary|Change in Heart Rate|Change in heart rate at termination of the index procedure as compared to the pre-procedure assessment.|Baseline to Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 2 participants were not evaluable.|||beats per minute||Standard Deviation|Mean
2654170|NCT01638468|Secondary|Systemic Systolic Arterial Blood Pressure|Systemic systolic arterial blood pressure at termination of the index procedure.|Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint.|||mmHg||Standard Deviation|Mean
2654171|NCT01638468|Secondary|Change in Systemic Systolic Arterial Blood Pressure|Change in systemic systolic arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.|Baseline to Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint|||mmHg||Standard Deviation|Mean
2654172|NCT01638468|Secondary|Pulmonary Systolic Arterial Blood Pressure|Pulmonary systolic arterial blood pressure at termination of the index procedure.|Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 1 participants were not evaluable.|||mmHg||Standard Deviation|Mean
2654173|NCT01638468|Secondary|Change in Systolic Pulmonary Arterial Blood Pressure|Change in systolic pulmonary arterial blood pressure at termination of the index procedure as compared to the pre-procedure assessment.|Baseline to Post Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 1 participant was not evaluable.|||mmHg||Standard Deviation|Mean
2654174|NCT01638468|Secondary|Death - Cardiac Cause|Number of participant deaths due to cardiac causes occurring within 3 months of the index procedure.|3 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint|||participants|||Number
2654175|NCT01638468|Secondary|Death - All Cause|Number of participant deaths due to any reason occurring within 3 months of the index procedure.|3 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint|||participants|||Number
2654176|NCT01638468|Secondary|Technical Success|Percentage of patients with successful placement and operation of the AngioJet catheter in the pulmonary arteries during the index procedure|Index Procedure|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint|||percentage of participants|||Number
2654177|NCT01638468|Primary|Change in Right Ventricular (RV) to Left Ventricular (LV) Ratio at 24 - 48 Hours as Measured by Echocardiography|The change in the subannular end-diastolic RV/LV ratio at 24-48 hrs following thrombectomy compared to baseline measurements as assessed by an independent core lab analysis. RV and LV values will be measured by echocardiography, a technique utilizing ultrasound waves to assess heart activity.|Baseline to 24-48 hours|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint|||ratio||Standard Deviation|Mean
2654178|NCT01638429|Secondary|% Stool Dry Weight|% stool dry weight [total stool dry weight (g)/total stool fresh weight (g)] was determined in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment stool samples were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)|Baseline and 1-60 days following completion of antibiotic treatment||||% stool dry weight||Standard Deviation|Mean
2654179|NCT01638429|Secondary|Bowel Symptoms - Straining|"Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms.~After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups:~Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)"|Baseline and 1-60 days following completion of antibiotic treatment||||0-100mm visual analogue scale||Standard Deviation|Mean
2654180|NCT01638429|Secondary|Bowel Symptoms - Diarrhea|"Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms.~After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups:~Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)"|Baseline and 1-60 days following completion of antibiotic treatment||||0-100mm visual analogue scale||Standard Deviation|Mean
2654250|NCT01637961|Secondary|Number of Participants With Adverse Events as Assessed by NCI CTCAE Version 4.0||Every cycle during treatment and 30 days after the last treatment, up to 5 years.|Eligible and treated patients|||Participants|||Count of Participants
2654181|NCT01638429|Secondary|Bowel Symptoms - Constipation|"Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms.~After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups:~Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)"|Baseline and 1-60 days following completion of antibiotic treatment||||0-100mm visual analogue scale||Standard Deviation|Mean
2654182|NCT01638429|Secondary|Bowel Symptoms - Abdominal Pain|"Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms.~After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups:~Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)"|Baseline and 1-60 days following completion of antibiotic treatment||||0-100mm visual analogue scale||Standard Deviation|Mean
2654183|NCT01638429|Secondary|Bowel Symptoms - Bloating|"Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms.~After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups:~Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)"|Baseline and 1-60 days following completion of antibiotic treatment||||0-100mm visual analogue scale||Standard Deviation|Mean
2654184|NCT01638429|Primary|Gastric Emptying|"Gastric Emptying times (minutes) were determined in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment gastric emptying studies were performed within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups:~Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)"|Baseline and 1-60 days following completion of antibiotic treatment||||minutes||Standard Deviation|Mean
2654185|NCT01638429|Primary|Average Daily Caloric Loss in Stool|"The daily caloric loss in stool for each subject was calculated by expressing the total number of kcalories lost in stool over a 3-day period as a percentage of the total number of kcalories ingested over the same 3 days (the number of calories ingested = the number available in meals provided less the number remaining in leftovers). Caloric content for meals, leftovers, and stool was determined by bomb calorimetry. This average daily caloric loss for each group was then compared before and after antibiotic therapy.~Post-treatment caloric harvest studies were performed within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups:~Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8)"|Baseline and 1-60 days following completion of antibiotic treatment||||%kcal lost||Standard Deviation|Mean
2654186|NCT01638429|Primary|Total Cholesterol Levels Before and After Antibiotic Therapy|"Total cholesterol levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics.Post-treatment blood samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days.~For analysis, subjects were grouped into two groups:~Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3)"|Baseline and 1-60 days following completion of antibiotic treatment||||mg/dL||Standard Deviation|Mean
2654187|NCT01638429|Primary|Low Density Lipoprotein (LDL) Levels Before and After Antibiotic Therapy|"LDL levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment blood samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days.~For analysis, subjects were grouped into two groups:~Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3)"|Baseline and 1-60 days following completion of antibiotic treatment||||mg/dL||Standard Deviation|Mean
2654188|NCT01638429|Primary|Stool Total Bacteria Levels|"Stool total bacteria levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics.Post-treatment stool samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups:~Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3)"|Baseline and 1-60 days following completion of antibiotic treatment||||colony forming units||Standard Deviation|Mean
2654251|NCT01637961|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.|||months||95% Confidence Interval|Median
2654189|NCT01638429|Primary|Stool Methanogen Levels|"Stool methanogen levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment stool samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days.~For analysis, subjects were grouped into two groups:~Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3)"|Baseline and 1-60 days following completion of antibiotic treatment||||colony forming units||Standard Deviation|Mean
2654190|NCT01638429|Primary|Number of Subjects Who Eradicated Methane on Breath Test|"Number of subjects who exhibited a decrease in breath methane levels to below detectable (below 3ppm) following antibiotic treatment.~After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment breath tests were performed within 2 weeks (14 days) of completing the course of antibiotics."|Baseline and 1-14 days following completion of antibiotic treatment||||participants|||Number
2654191|NCT01638390|Secondary|Safety- Patient Symptoms|A standardized quality of vision (QoV) questionnaire was used in the study. A score is generated and was used to compare the results from baseline to the 12 month visit. Number of participants who improved, stayed the same, or worsened with regards to the frequency, severity, and bothersomeness of symptoms are reported.|12 months||||Participants|||Count of Participants
2654192|NCT01638390|Primary|Stability Criteria- Change Between Visits Within 0.50 Diopter (D)|Number of participants with a change in postoperative refraction within 0.50 D between the 3 and 6 month visits. Stability was identified at the 6 month visit for the study.|6 months||||Participants|||Count of Participants
2654193|NCT01638390|Primary|Safety- Contrast Sensitivity|Number of participants who increased, remained the same, and decreased in contrast sensitivity. There are 4 different frequencies (1.5, 3.0, 6.0, and 12.0) which will be tested and are more difficult to detect as the frequency number increases.|12 months||||Participants|||Count of Participants
2654194|NCT01638390|Primary|Safety- Adverse Events|Number of participants for each type of adverse event. Target of less than 1% of participants for each type of adverse event.|12 months||||Participants|||Count of Participants
2654195|NCT01638390|Primary|Safety- Induced Manifest Refractive Astigmatism|Number of participants with an increase of astigmatism of greater than 2.00 D cylinder from the preoperative values. Target is less than 5% of participants.|12 months||||Participants|||Count of Participants
2654196|NCT01638390|Primary|Safety- Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA)|"Number of participants with worse than 20/40 visual acuity with a preoperative BSCVA (Best Spectacle Corrected Visual Acuity) 20/20 or better. Target is less than 1% of study participants.~Less than 5% of participants with BCVA loss ≥ 2 lines"|12 months||||Participants|||Count of Participants
2654197|NCT01638390|Primary|Stability Criteria- Change Between Visits Within 1.00 Diopter (D)|Number of participants with a change in postoperative refraction within 1.00 D between the 3 and 6 month visits. Stability was identified at the 6 month visit for the study.|6 months||||Participants|||Count of Participants
2654198|NCT01638390|Primary|Effectiveness- Improvement in UCVA Following Treatment|Number of participants with uncorrected visual acuity (UCVA) of 20/40 or better at the point of stability. .This is vision without any form of prescription. A target of 85% of participants is required.|12 month|The number reflected at the 12 month visit is the effectiveness population.|||Participants|||Count of Participants
2654199|NCT01638390|Primary|Effectiveness- Predictability|Number of participants with a decrease in manifest refraction spherical equivalent (MRSE) to within ± 1.00 D and ± 0.50 D of the intended refractive outcome at the point at which stability is first reached. The MRSE is the amount of prescription needed to obtain your best corrected vision as compared to your preoperative best corrected vision. A minimum of 75% of eyes should have an achieved refraction within ± 1.00 D of the intended outcome, and at least 50% of eyes should be within ± 0.50 D of the intended outcome.|12 months|The number reflected at the 12 month visit is the effectiveness population.|||Participants|||Count of Participants
2654200|NCT01638312|Primary|Fructose Identification in Urine to Detect the Viral Infection : Number of Participants With Positive and Negative Waveform|"This detection technique, after a viral infection caused by the use of cell pathological changes and urine metabolic waste - fructose concentration, derivatives.Health News voltage changes to detect viral pathogens of activity and virulence. Because viral infection caused by the voltage change has its typical, So you can use voltage measurements to calibrate the presence and activity of a viral infection.~1.How to interpretation the data The gap between values on X-axis is σ, and 50 is a reference to the center position. For example, the sample maybe contain with HIV virus if σ≧10 units.~σ≧10 abnormal positive (+) σ＜10 normal negative (-)"|Participants provided urine samples once||||participants|||Number
2654201|NCT01638000|Secondary|Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit|A responder is defined as a participant with ≥2 point improvement in PPBC from baseline.|Baseline to Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||percentage of participants|||Number
2654202|NCT01638000|Secondary|Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit|A responder is defined as a participant with ≥1 point improvement in PPBC from baseline.|Baseline to Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||percentage of participants|||Number
2654203|NCT01638000|Secondary|Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit|A responder is defined as a participant with >=1 or >=2 or >=3 or >=4 or >=5 or 6-point improvement from baseline in TS-Likert scale.|Baseline to final visit (up to Week 12)|FAS population. LOCF was used.|||percentage of participants|||Number
2654204|NCT01638000|Secondary|Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12|A responder is defined as a participant with ≥1, ≥2, ≥3, ≥4, ≥5 or 6-point improvement from baseline in TS-Likert scale.|Baseline to Week 12|FAS population.|||percentage of participants|||Number
2654205|NCT01638000|Secondary|Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit|A responder is defined as a participant with >=10 points improvement in the total HRQL score from baseline.|Baseline to Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||percentage of participants|||Number
2654206|NCT01638000|Secondary|Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit|A responder is defined as a participant with ≥10 points improvement in symptom bother from baseline.|Baseline to Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||percentage of participants|||Number
2654207|NCT01638000|Secondary|Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale|"The Treatment Satisfaction (TS)-Likert Scale was a self-rated scale with the participant answering the question How satisfied were you with your treatment? with on a scale from 1 (extremely dissatisfied) to 7 (extremely satisfied)."|Baseline and Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2654208|NCT01638000|Secondary|Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)|"The Treatment Satisfaction (TS)-Visual Analogue Scale (VAS) was a self-rated scale with the participant answering the question Are you satisfied with your treatment? and placing a vertical mark on a line from 0 (No, not at all) to 10 (Yes, completely)."|Baseline and Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2654209|NCT01638000|Secondary|Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)|The Patient Perception of Bladder Condition (PPBC) questionnaire is a single-item questionnare used to assess participants' perceptions and impressions of their bladder condition. Participants assessed their bladder condition using a 6-point categorical scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2654210|NCT01638000|Secondary|Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q|The OAB-q is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping, concern, sleep, social interaction). The total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2654211|NCT01638000|Secondary|Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)|The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2654212|NCT01638000|Secondary|Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.|||participants|||Number
2654213|NCT01638000|Secondary|Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.|||participants|||Number
2654214|NCT01638000|Secondary|Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.|||participants|||Number
2654215|NCT01638000|Secondary|Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.|||participants|||Number
2665364|NCT01534208|Primary|Mean Change From Baseline FPG|Mean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks)|6 months||||mg/dL||Standard Deviation|Mean
2654216|NCT01638000|Secondary|Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and final visit (up to Week 12)|FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.|||participants|||Number
2654217|NCT01638000|Secondary|Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
2654218|NCT01638000|Secondary|Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
2654219|NCT01638000|Secondary|Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
2654220|NCT01638000|Secondary|Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
2654221|NCT01638000|Secondary|Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 12|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
2654222|NCT01638000|Secondary|Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
2654223|NCT01638000|Secondary|Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
2654224|NCT01638000|Secondary|Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
2654225|NCT01638000|Secondary|Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
2654226|NCT01638000|Secondary|Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 8|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
2654293|NCT01637272|Secondary|﻿Insulin Levels During OGTT|Absolute insulin levels at the end of M3, M6, M12|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||pmol/L||Standard Deviation|Mean
2654227|NCT01638000|Secondary|Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
2654228|NCT01638000|Secondary|Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
2654229|NCT01638000|Secondary|Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
2654230|NCT01638000|Secondary|Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire|The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who has non-missing values at both Baseline and specified visit.|||participants|||Number
2654231|NCT01638000|Secondary|Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire|The European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform [extreme problems]).|Baseline and Week 4|FAS population who have non-missing values at both Baseline and specified visit.|||participants|||Number
2654232|NCT01638000|Secondary|Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit|A responder is defined as a participant who reported incontinence episodes at baseline and reported no incontinence episodes during the treatment period at specified visit.|Week 4, Week 8, Week 12|FAS-I population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||percentage of participants|||Number
2654233|NCT01638000|Secondary|Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit|A responder is defined as a participant with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at specified visit.|Week 4, Week 8, Week 12|FAS-I population. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||percentage of participants|||Number
2654234|NCT01638000|Secondary|Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit|A responder is defined as a participant who has ≥8 micturitions at baseline and has <8 micturitions per 24 hours during the treatment period at each specified visit, where change from baseline is <0.|Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. N is the number of participants with available data at each timepoint.|||percentage of participants|||Number
2654235|NCT01638000|Secondary|Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment|A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8, Week 12|FAS population. Only participants with at least one nocturia episode at baseline were included in the analysis. N is the number of participants with available data at each time point.|||nocturia episodes||Standard Error|Least Squares Mean
2654236|NCT01638000|Secondary|Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit|A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The total number of nocturia episodes were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.|Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. Only participants with at least one nocturia episode at baseline were included in the analysis. N is the number of participants with available data at each time point.|||nocturia episodes||Standard Error|Mean
2654237|NCT01638000|Secondary|Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment|The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8 , Week 12|FAS population. Only participants with at least one pad used at baseline were included in this analysis. N is the number of participants with available data at each time point.|||pads||Standard Error|Least Squares Mean
2654238|NCT01638000|Secondary|Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit|The total number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.|Week 4, Week 8, Week 12|FAS population. LOCF was used in final visit only. Only participants with at least one pad used at baseline were included in this analysis. N is the number of participants with available data at each time point.|||pads||Standard Error|Mean
2654239|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency|Urgency level was rated by the participant during the 3-day micturition diary period using the PPIUS 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used in final visit only. N is the number of participants with available data at each time point.|||units on a scale||Standard Error|Least Squares Mean
2654240|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours|An urgency episode is a sudden compelling desire to pass urine immediately followed by an incontinent event or the patient having to rush to the toilet and make it in time; severity recorded as 3 (severe urgency) or 4 (urgency incontinence) on the Patient Perception of the Intensity of Urgency Scale (PPIUS) validated scale. The mean number of urgency episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8, Week 12|FAS population. LOCF was used for final visit only. Only participants with at least one urgency episode (grade 3 or 4) at baseline were included in this analysis. N is the number of participants with available data at each time point.|||urgency episodes||Standard Error|Least Squares Mean
2654241|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours|An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8, Week 12|FAS-I population. Only participants with at least one urgency incontinence episode at baseline were included in the analysis. N is the number of participants with available data at each time point.|||urgency incontinence episodes||Standard Error|Least Squares Mean
2654242|NCT01638000|Secondary|Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit|An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The total number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.|Week 4, Week 8, Week 12|FAS-I population. LOCF was used for final visit only. Only participants with at least one urgency incontinence episode at baseline were included in the analysis. N is the number of participants with available data at each time point.|||urgency incontinence episodes||Standard Error|Mean
2654243|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode is any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and Week 4, Week 8, Week 12|FAS-I population. N is the number of participants with available data at each time point.|||incontinence episodes||Standard Error|Least Squares Mean
2654244|NCT01638000|Secondary|Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit|An incontinence episode is any involuntary leakage of urine. The total number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.|Week 4, Week 8, Week 12|FAS-Incontinence (FAS-I) - consisted of all FAS participants with ≥1 incontinence episode at baseline. LOCF was used for final visit only. N is the number of participants with available data at each time point.|||incontinence episodes||Standard Error|Mean
2654245|NCT01638000|Secondary|Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours||Baseline and Week 4, Week 8, Week 12|Full Analysis Set (FAS) - consisted of all randomized participants who took ≥ 1 dose of double-blind study drug and who recorded ≥1 micturition measurement in the baseline diary and ≥1 micturition measurement in a post-baseline diary. N is the number of participants with available data at each time point.|||micturitions||Standard Error|Least Squares Mean
2654246|NCT01638000|Secondary|Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period|A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE; defined as any untoward medical occurrence in a patient administered a study drug) that started or worsened in the period from the first double-blind medication intake until 30 days after the last double-blind medication intake. The following TEAEs were selected for inclusion in the analysis: Dry mouth (aptyalism, dry mouth, dry throat), constipation (constipation), blurred vision (vision blurred, myopia, refraction disorder, accommodation disorder).|From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)|SAF population|||percentage of participants|||Number
2654247|NCT01638000|Primary|Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours|A micturition is any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.|Baseline and final visit (up to Week 12)|Per Protocol Set (PPS) - all randomized participants who took ≥1 dose of double-blind study drug and who recorded ≥1 micturition in the baseline diary and ≥1 micturition in a post-baseline diary who had completed the study with no major protocol violations which could impact the primary endpoint. Last observation carried forward (LOCF) was used.|||micturitions||Standard Error|Least Squares Mean
2654248|NCT01637961|Other Pre-specified|Aurora A Kinase Expression|Aurora A Kinase expression will be assessed for associations with patient demographics and clinical outcome (response, PFS at 6 months, PFS, and OS).|Up to 5 years|||||||
2654249|NCT01637961|Secondary|Progression Free Survival|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.|every other cycle for the first 6 months; then every 3 months thereafter until disease progression is confirmed; up to 5 years|Eligible and treated patients|||months||90% Confidence Interval|Median
2654252|NCT01637961|Primary|Tumor Response|Complete and Partial Tumor Response by RECIST 1.1. Patient response uses best overall response while on therapy. Complete response is defined as the disappearance of all target lesions and non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in the short axis to <10 mm. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.|Every other cycle for the first 6 months; then every 3 months thereafter until withdrawal from study treatment or disease progression is confirmed.|Eligible and treated patients|||percentage of participants||90% Confidence Interval|Number
2654253|NCT01637961|Primary|Progression-free Survival (PFS) > 6 Months|Whether or not the patient survived progression-free for at least 6 months. 90% confidence interval (Bonferroni Corrected). Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Progression includes the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.|Assessed every other cycle for the first 6 months; then every 3 months from the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.|Eligible and Treated Patients|||percentage of participants||90% Confidence Interval|Number
2654254|NCT01637935|Secondary|Stage of Bladder Cancer (10 Year Analysis)||January 1, 1997 to December 31, 2012|Participants diagnosed with bladder cancer.|||percentage of participants|||Number
2654255|NCT01637935|Secondary|Incident Diagnosis of Bladder Cancer by Cumulative Dose of Pioglitazone (10 Year Analysis)||January 1, 1997 to December 31, 2012|All participants.|||events per 100,000 person years||95% Confidence Interval|Number
2654256|NCT01637935|Secondary|Incident Diagnosis of Bladder Cancer by Duration of Pioglitazone Therapy (10 Year Analysis)||January 1, 1997 to December 31, 2012|All participants.|||events per 100,000 person years||95% Confidence Interval|Number
2654257|NCT01637935|Secondary|Incident Diagnosis of Bladder Cancer by Time Since Starting Pioglitazone (10 Year Analysis)||January 1, 1997 to December 31, 2012||||events per 100,000 person years||95% Confidence Interval|Number
2654258|NCT01637935|Primary|Incident Diagnosis of Bladder Cancer (10-year Analysis)|Incident bladder cancers were identified from January 1, 1997 to December 31, 2012.|January 1, 1997 to December 31, 2012|All participants.|||events per 100,000 person years||95% Confidence Interval|Number
2654259|NCT01637922|Primary|Naloxone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
2654260|NCT01637922|Primary|Naloxone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
2654261|NCT01637922|Primary|Naloxone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[pg*h/ml]||Geometric Coefficient of Variation|Geometric Mean
2654262|NCT01637922|Primary|Norbuprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
2654263|NCT01637922|Primary|Norbuprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
2655128|NCT01629134|Primary|Injector Rating of the Natural Look and Feel of the Lips|Percentage of injectors who rated the look and feel of subjects' lips as being extremely natural, very natural, slightly natural, and not natural.|4 weeks|All subjects who met the criteria and treatment was initiated|||Percentage of subjects|||Number
2654264|NCT01637922|Primary|Norbuprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[pg*h/ml]||Geometric Coefficient of Variation|Geometric Mean
2654265|NCT01637922|Secondary|Pharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Subjective Opiate Withdrawal Scale (SOWS)-Change From Baseline|The SOWS is a subjective scale self-evaluated by the subject. The SOWS shows items reflecting the common motor, autonomic, gastrointestinal, musculo-skeletal, and psychic symptoms of opiate withdrawal. Subjects are instructed to rate each symptom on a scale of 0 to 4 (0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely) at designated times [c.f. Section 3.1]. The minimum possible SOWS score is 0, the maximum 64. The following subjective criteria are answered by the subject using the scale below: 1) I feel anxious, 2) I feel like yawning 3) I am perspiring, 4) My eyes are watering, 5) My nose is running, 6) I have goose flesh, 7) I am shaking 8) I have hot flushes, 9) I have cold flushes, 10) My bones and muscles ache, 11) I feel restless, 12) I feel nauseous, 13) I feel like vomiting, 14) My muscles twitch, 15) I have cramps in my stomach, 16) I feel like shooting up now. Higher score indicates increasing severity of opiate withdrawal syndrome.|Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12 and End of treatment|This set included all subjects who took at least one dose of study drug.|||units on a scale||Full Range|Median
2654266|NCT01637922|Primary|Buprenorphine: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[pg/mL]||Geometric Coefficient of Variation|Geometric Mean
2654267|NCT01637922|Primary|Buprenorphine: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[pg/ml]||Geometric Coefficient of Variation|Geometric Mean
2654268|NCT01637922|Primary|Buprenorphine: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[pg*h/ml]||Geometric Coefficient of Variation|Geometric Mean
2654269|NCT01637922|Secondary|Pharmacodynamic Assessment of Withdrawal From Either Methadone or Buprenorphine/Naloxone Using the Objective Opiate Withdrawal Scale (OOWS)-Change From Baseline|The OOWS is conducted by a trained independent examiner for either the presence or absence of the following symptoms during a 10 minute observation period at designated times during the trial. The minimum possible OOWS score is 0 and the maximum possible score is 13. Objective criteria: Yawning, Rhinorrhoea, Piloerection, perspiration, lacrimation, mydriasis, hot and cold flushes, restlessness, vomiting, tremors, anxiety, muscle twitches, abdominal cramps. Higher score indicates increasing severity of opiate withdrawal syndrome.|Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12 and End of treatment|This set included all subjects who took at least one dose of study drug.|||units on a scale||Full Range|Median
2654270|NCT01637922|Primary|S-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[ng/mL]||Geometric Coefficient of Variation|Geometric Mean
2654271|NCT01637922|Primary|S-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[ng/mL]||Geometric Coefficient of Variation|Geometric Mean
2654294|NCT01637272|Secondary|﻿Response Rate in Hematocrit Levels|﻿Percentage of patients with change in hematocrit >= 3% from pre-OGTT to 30 minutes post OGTT.|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||Percentage of participants|||Number
2654272|NCT01637922|Primary|S-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[ng*h/ml]||Geometric Coefficient of Variation|Geometric Mean
2654273|NCT01637922|Primary|R-methadone: Geometric Mean Steady-state C24hr on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for steady-state plasma concentration of faldaprevir 24 hours after the last dose|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[ng/mL]||Geometric Coefficient of Variation|Geometric Mean
2654274|NCT01637922|Primary|R-methadone: Geometric Mean Steady-state Cmax on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for the maximum measured concentration of faldaprevir in plasma at steady state.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[ng/ml]||Geometric Coefficient of Variation|Geometric Mean
2654275|NCT01637922|Primary|R-methadone: Geometric Mean Steady-state AUC0-24 on Day 1 and on Day 9.|These are the unadjusted summary statistics on the original scale for area under the concentration time curve (AUC) of faldaprevir in plasma over a uniform dosing interval from 0 to 24 hours.|0 hours, 0.5 hours, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours on Day 1 and Day 9|This set included all subjects who took at least one dose of study drug and had evaluable data for at least one observation for at least one primary endpoint. Subjects considered to be not evaluable, if the subject had a protocol deviation relevant to relative bioavailability. Or experienced emesis and vomiting at or before two times median tmax.|||[ng*h/mL]||Geometric Coefficient of Variation|Geometric Mean
2654276|NCT01637870|Primary|Wound Complication Rate|Wound infection, separation or deep infection|Up to 6 weeks from time of surgery||||participants|||Number
2654277|NCT01637584|Secondary|Pittsburgh Sleep Quality Index (PSQI):|Self-report sleep quality measure. Scores range from 0 to 21, with higher scores reflecting poorer sleep quality.|Baseline and post-treatment at 8-10 weeks|9 of the 20 participants who were randomized to prazosin and 13 of the participants randomized to prazosin provided scans pre- and post-treatment that were of sufficiency quality to be included in the final analyses.|||units on a scale||Standard Deviation|Mean
2654278|NCT01637584|Primary|Whole Brain Relative Regional Cerebral Metabolic Rate of Glucose|The reported Z value reflect the magnitude of the state difference (Wake vs. Non-REM or Wake vs. REM) within the prazosin group pre-to-post treatment, and after using a mask to adjust for the spurious effects of the passage of time.|Baseline and post-intervention at 8-10 weeks|9 of the 20 participants who were randomized to prazosin and 13 of the participants randomized to placebo provided scans pre- and post-treatment that were of sufficiency quality to be included in the final analyses.|||Z values|||Number
2654279|NCT01637272|Secondary|LAR PK Parameter: Ctrough - at Steady State (ss) by Dose|In the LAR treatment phase, monthly injections of pasireotide LAR 10, 20, 30 and 40 mg were given to participants and trough concentration at steady state (Ctrough,ss) were obtained but due to only 1 participant in the 40mg arm, standard deviation could not be calculated.|M4 to M12|The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).|||ng/mL||Standard Deviation|Mean
2654280|NCT01637272|Secondary|Pasireotide Concentrations in LAR Phase|Summary of pasireotide concentrations following monthly i.m. injections of pasireotide LAR by incident dose (LAR Pharmacokinetic set)|M7 to M12|The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).|||ng/mL||Standard Deviation|Mean
2654281|NCT01637272|Secondary|Summary of LAR PK Parameters by Dose|Summary of plasma PK parameter Cmax, p2 , 2nd injection and Ctrough, d28 associated with LAR injection (LAR Core phase)|M4 to M6|The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).|||ng/mL||Standard Deviation|Mean
2654282|NCT01637272|Secondary|Plasma PK Parameter of AUC0-3h, d21, End _inj and AUC0-3h, d28, 3rd_inj Associated With LAR (LAR Core Phase)||M4 to M6|The LAR PK analysis set consisted of all patients who received at least one of the scheduled full monthly im LAR injections and had evaluable PK data (concentration) in the LAR phase of the study (Visit 9 through end of LAR phase visit).|||hr*ng/mL||Standard Deviation|Mean
2654283|NCT01637272|Secondary|Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Tmax, ss, After s.c. Injection|A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.|M1 to M3|The sc PK analysis set consisted of all patients who received at least one of the scheduled full daily sc dose (3 injections) and had evaluable PK data (concentration) in the sc dose escalation phase of the study (Visit 2 through Visit 8).|||hr||Full Range|Median
2655129|NCT01629134|Primary|Subject Rating of the Natural Look and Feel of the Lips|Percentage of subjects rating the look and feel of their lips as being extremely natural, very natural, slightly natural, and not natural.|4 weeks|All subjects who met the criteria and treatment was initiated|||Percentage of subjects|||Number
2654284|NCT01637272|Secondary|Plasma Pharmacokinetic (PK) Parameter of Pasireotide: AUC0-3h, ss, After s.c. Injection|A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.|M1 to M3|The sc PK analysis set consisted of all patients who received at least one of the scheduled full daily sc dose (3 injections) and had evaluable PK data (concentration) in the sc dose escalation phase of the study (Visit 2 through Visit 8).|||hr*ng/mL||Standard Deviation|Mean
2654285|NCT01637272|Secondary|Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Cmax, ss (Steady State) and Ctrough, ss, After s.c. Injection|A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes. 'n' = number of subjects with non-missing values|M1 to M3|The sc PK analysis set consisted of all patients who received at least one of the scheduled full daily sc dose (3 injections) and had evaluable PK data (concentration) in the sc dose escalation phase of the study (Visit 2 through Visit 8).|||ng/mL||Standard Deviation|Mean
2654286|NCT01637272|Secondary|Patient Global Assessment at the End of Months 3, 6 and 12|"Treatment with pasireotide LAR (both early and late dumping scores), was assessed by patient global assessment. Patient Global Assessment served as an additional approach to symptom based measurement by DSQ. It incorporated a patient global assessment question: Considering all the ways that your disease affects you, rate how you are feeling during the last 7 days compared with your situation before starting the study .Patients Global Assessment was measured utilizing a 7 point scale (from 1=a lot worse to 7= a lot better)."|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||scores on a scale||Standard Deviation|Mean
2654287|NCT01637272|Secondary|﻿Dumping Score Questionnaire (DSQ) at the End of Months 3, 6 and 12|Absolute Dumping Score Questionnaire (DSQ) scores at end of Months 3, 6 & 12 from s.c. baseline. DSQ = disease-specific PRO scale. The questionnaire uses a 5-point Likert scale (0, none; 1, mild; 2, moderate; 3, severe; 4, very severe) to ask Pt. to evaluate intensity of 10 early dumping symptoms (within 30 minutes (<30 minutes) after food ingestion). The questionnaire also evaluates 5 late dumping symptoms (more than 1.5 hours (>90 minutes) after food ingestion). Early & late dumping score calculated by adding the scores of respective questions. A cumulative dumping score is obtained by adding early & late scores. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients used DSQ. DSQ Range: (min (None) - max (Very severe)): Early dumping: 0-40; Late Dumping: 0-20; Cumulative: 0-60. Lower scores represent a better outcome.|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||scores on a scale||Standard Deviation|Mean
2654288|NCT01637272|Secondary|﻿Dumping Severity Score (DSS) at the End of Months 3, 6 and 8|Absolute Dumping Severity Score (DSS) scores at end of M3, M6 & M8. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients were expected to use DSQ. No results available for M12 as last patient that answered the DSS was at M8. DSS = disease-specific patient (Pt.) reported outcome (PRO) questionnaire uses a 4-point Likert scale (0, absent; 1, mild; 2, relevant; 3, severe; 4) to ask Pt. to evaluate intensity of early dumping symptoms (within 30 minutes (<30 minutes) after food ingestion). The questionnaire also evaluates 65 late dumping symptoms (more than 1.5 hours (>90 minutes) after food ingestion). Early & late dumping score calculated by adding the scores of the respective questions. Cumulative dumping score is obtained by adding early & late scores. DSS Range (min (absent) - max (severe)): Early dumping: 0-24; Late Dumping: 0-18; Cumulative: 0-42. Lower scores represent a better outcome.|M3, M6, M8|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||scores on a scale||Standard Deviation|Mean
2654289|NCT01637272|Secondary|﻿Health-related Quality of Live (HRQoL) Short Form- 36 (SF-36) Score(s)|Absolute HRQoL SF-36 Scores at end of the Months 3, 6 and 12 from s.c. baseline. SF-36, a 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. Items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||scores on a scale||Standard Deviation|Mean
2654290|NCT01637272|Secondary|﻿﻿Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT|Absolute ﻿﻿﻿Gastric Inhibitory Polypeptide (GIP) levels at the end of Months 3, 6 and 12 at different time points.|M3, M6, M12|"The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase.~The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase."|||pmol/L||Standard Deviation|Mean
2654291|NCT01637272|Secondary|﻿﻿Glucagon-like Peptide 1 (GLP-1) Levels During OGTT|Absolute ﻿Glucagon-like peptide 1 (GLP-1) levels at the end of at the end of Months 3, 6 and 12 at different time points.|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||pmol/L||Standard Deviation|Mean
2654292|NCT01637272|Secondary|﻿Glucagon Levels During OGTT|Absolute glucagon levels at the end of Months 3, 6 & 12|M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||pmol/L||Standard Deviation|Mean
2654295|NCT01637272|Secondary|Response Rate in Pulse Rate|Pulse rate was defined as percentage of patients with change in pulse rate >=10 bpm from pre-OGTT to 30 minutes post OGTT.|at baseline, M3, M6, M12|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase. The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||Percentage of participants|||Number
2654296|NCT01637272|Secondary|Response Rate in Plasma Glucose Level|Response rate is defined as percentage of patients with no glucose values < 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of 6 months (end of LAR/Core phase) and at the end of 12 months (extension phase)|at Month 6 (M6), Month 12 (M12)|The LAR full analysis set (LAR FAS) consisted of all patients who received at least one dose of pasireotide LAR during core LAR phase.|||percentage of participants||95% Confidence Interval|Number
2654297|NCT01637272|Primary|Response Rate in Plasma Glucose Level|Response rate is defined as percentage of patients with no glucose values < 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of s.c. dose escalation phase|at Month 3 (M3)|The sc full analysis set (sc FAS) consisted of all patients who received at least one dose of pasireotide sc during core sc phase.|||percentage of participants||95% Confidence Interval|Number
2654298|NCT01637246|Secondary|Percentage of Patients Continuing on Therapy After 12 Weeks|Percentage of patients continuing on therapy after 12 weeks was assessed as Yes or No.|12 Weeks|All patients who met the study entry criteria and have data for this outcome measure|||Percentage of Patients|||Number
2654299|NCT01637246|Secondary|Percentage of Patients Who Maintained Better Compliance With Treatment|Percentage of patients who maintained better compliance with treatment than prior therapy was assessed by the patient on a 3-point scale (better, equal, and worse compliance).|12 Weeks|All patients who met the study entry criteria and have data for this outcome measure|||Percentage of Patients|||Number
2654300|NCT01637246|Secondary|Physician Assessment of Tolerability Using a 4-Point Scale|Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported.|12 Weeks|All patients who met the study entry criteria and have data for this outcome measure|||Percentage of Patients|||Number
2654301|NCT01637246|Secondary|Patient Assessment of Tolerability Using a 4-Point Scale|Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported.|12 Weeks|All patients who met the study entry criteria and have data for this outcome measure|||Percentage of Patients|||Number
2654302|NCT01637246|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.|Baseline, 12 Weeks|All patients who met the study entry criteria and have data for this outcome measure|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2654303|NCT01637090|Secondary|Effect of mTOR on Tumors|Determine mTOR (mammilian target of rapamycin) pathway activation and number of regulatory T cells (Tregs) in pre-treated tumor tissue and evaluate changes following treatment|one year|Study was pre-maturely terminated. No data were collected for the Outcome Measure||||||
2654304|NCT01637090|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Determine the adverse event profile and tolerability of everolimus in patients with CTCL|Up to one year||||participants|||Number
2654305|NCT01637090|Secondary|Progression-free Survival|Determine progression-free survival of CTCL patients treated with everolimus|two years after discontinuing study treatment|Study was pre-maturely terminated. No data were collected for the Outcome Measure||||||
2654306|NCT01637090|Secondary|Time to Response|Determine time to response (TTR)/duration of objective response (DOR)|three months|Study was pre-maturely terminated. No data were collected for the Outcome Measure||||||
2654307|NCT01637090|Primary|Efficacy of Treatment|Determine the efficacy of everolimus in the treatment of CTCL as overall response rate (ORR)|12 months after beginning treatment|Study was pre-maturely terminated. No data were collected for the Outcome Measure||||||
2654308|NCT01637077|Secondary|Area Under the Curve (AUC) of EORTC Sensory, Autonomic, and Motor Neuropathy Subscales|Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neurophathy Module (EORTC QLQ-CIPN20) Sensory, Autonomic, and Motor Neuropathy Subscales. The EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48), motor (items 37, 38, 41-45, 49), and autonomic (items 46, 47, 50) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the 6-month assessment. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to 6-months are averaged to yield the aAUCpa per patient per subcale.|From treatment initiation to 6 months.||||average(subscale value*assessment)||Standard Deviation|Mean
2654309|NCT01637077|Secondary|The Percentage of Patients Who Report, at Week's End, Using Opioids|"The percentage of patients who report, at week's end, using opioids (Have you used opioids like codeine, oxycodone, or morphine for this pain over the past week?) are reported by arm below. This question was only supposed to be answered by patients who responded yes to the first question. Currently, all responses are included, regardless of whether the patient should've responded or not."|From treatment initiation to 6 days following treatment initiation; up to 7 days||||percentage of patients|||Number
2654310|NCT01637077|Secondary|The Percentage of Patients Who Report, at Week's End, Using Non-prescription Pain Medications|"The percentage of patients who report, at week's end, using non-prescription pain medications (Have you used non-prescription meds like aspirin, Tylenol, Motrin, Ibuprofen, or Advil over the past week?) are reported by arm below. This question was only supposed to be answered by patients who responded yes to the first question. Currently, all responses are included, regardless of whether the patient should've responded or not."|From treatment initiation to 6 days following treatment initiation; up to 7 days||||percentage of patients|||Number
2655261|NCT01628107|Secondary|Mean Hemoglobin Levels: Over Week 1 to 48||Week 1 up to Week 48|"FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||g/dL||Standard Deviation|Mean
2654311|NCT01637077|Secondary|The Worst Pain Reported at the End of the Week for the Overall Week (Item 2 Appendix V)|"The worst pain reported at the end of the week for the overall week (New aches and pains at their worst over the past week) are reported below. This question was only supposed to be answered by patients who responded yes to the first question. Currently, all responses are included, regardless of whether the patient should've responded or not. The worst pain reported at the end of the week for the overall week (item 2 appendix V: Please rate any aches/pains that you have by circling ONE number that best describes your aches/pains at its worst over the last week.) Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be)."|From treatment initiation to 6 days following treatment initiation; up to 7 days||||units on a scale||Standard Deviation|Mean
2654312|NCT01637077|Secondary|The Percentage of Patients Who Report the Development of New Aches/Pains That They Attribute to Paclitaxel|The percentage of patients who report the development of new aches/pains that they attribute to paclitaxel in the first week of chemotherapy are reported by arm below.|From treatment initiation to 6 days following treatment initiation; up to 7 days||||percentage of patients|||Number
2654313|NCT01637077|Secondary|The Percentage of Patients Taking Opioid Medications|The percentage of patients taking opioid medications are reported below by arm.|From treatment initiation to 6 months.||||percentage of patients|||Number
2654314|NCT01637077|Secondary|The Percentage of Patients Who Use Non-prescription Pain Medications|The percentage of patients who use non-prescription pain medications are reported by arm below.|From treatment initiation to 6 months.||||percentage of patients|||Number
2654315|NCT01637077|Secondary|Percentage of Participants With Grade 3 or Higher Adverse Events Considered At Least Possibly Related to Treatment|"The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below."|Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment||||percentage of patients|||Number
2654316|NCT01637077|Secondary|Area Under the Curve Per Assessment (aAUCpa) of Worst, Average and Least Pain (Items 1-3 Appendix IV) for the First Cycle of Treatment.|"Average Area Under the Curve per assessment (aAUCpa) of worst, average, and least pain (items 1-3 app. IV; Please rate any aches/pains that are NEW since your last dose of paclitaxel, and that you think might be related to your chemotherapy treatment by circling ONE number that best describes your aches/pains at its WORST in the last 24 hours., Please rate the same aches/pains by circling the ONE number that best describes your aches/pains at its LEAST in the last 24 hours., Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.) for the first cycle of treatment. Scores are reported on a 0-100 scale, where 100=better outcome QOL. The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the day-6 assessment."|From treatment initiation to 6 days following treatment initiation; up to 7 days|The number analyzed for average pain over the past 24 hours differs from the overall number analyzed due to missing data.|||average(subscale value*assessment)||Standard Deviation|Mean
2654317|NCT01637077|Primary|Maximum of the Average Pain Scores (Item 3, Appendix IV) Over the Period From Treatment Initiation to Day 7 (for Cycle 1).|"Maximum of average pain scores over 6 days following initiation of treatment. Average pain over the first 6 days following treatment initiation. Maximum of the average pain scores (item 3, appendix IV; Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.) over the period from treatment initiation to day 7 (for cycle 1). Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be)."|From treatment initiation to 6 days following treatment initiation; up to 7 days||||units on a scale||Standard Deviation|Mean
2654318|NCT01637077|Primary|Worst of the Pain Scores for the Week Following the First Cycle of Paclitaxel Administration, Paclitaxel-associated Acute Pain Syndrome (P-APS) Pain Score|Worst of the pain scores for the week following the first cycle of paclitaxel administration, as measured by a question on the daily post-paclitaxel questionnaire. Worst pain over the first 6 days following treatment initiation. Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be).|From treatment initiation to 6 days following treatment initiation; up to 7 days||||units on a scale||Standard Deviation|Mean
2654319|NCT01636986|Primary|Mean Change From Baseline in Subjective Contact Lens-related Dryness Symptoms at Week 4 as Assessed by the CLDEQ|Contact lens symptoms were evaluated using the Contact Lens and Dry Eye Questionnaire (CLDEQ). The participant indicated the frequency with which 9 common contact lens-related ocular surface dryness symptoms were experienced over the previous week. Each symptom was rated on a 5-point scale (1=never, 5=constantly). Both eyes contributed to the mean. A more negative change number indicates a greater perceived improvement, namely, lessening of the symptom.|Day 0, Week 4|All enrolled and randomized participants who completed the study.|||Units on a scale||Standard Deviation|Mean
2654320|NCT01636960|Secondary|Number of Participants Discontinuing Study Drug Because of AEs|An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose to last dose of treatment; up to 260 Weeks|All participants receiving at least one dose of study drug.|||Participants|||Number
2654321|NCT01636960|Secondary|Safety: Number of Participants Experiencing Adverse Events (AEs)|An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose through follow-up; up to 265 Weeks|All participants who received at least one dose of study drug.|||Participants|||Number
2654322|NCT01636960|Primary|Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase|A DLT was an event (clinical or laboratory) that resulted in a change in the given dose.|From first dose to end of induction phase; up to 8 Weeks|All participants in the induction phase of the study|||Participants|||Number
2654388|NCT01636778|Primary|Number of Participants Whose Platelet Counts Maintained at >=50 Gi/L During Part 2|"Participants were assessed for continuously maintaining platelet counts >=50 Gi/L during Part 2.~Platelet counts were measured by blood draw."|From Antiviral Baseline to up to Week 48 in Part 2|Full Analysis Set 2 (FAS2) Population: all participants enrolled in Part 2.|||Participants|||Number
2654323|NCT01636947|Secondary|Percentage of Participants With No Vomiting - Acute and Delayed Stages|A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC.|Day 1, Day 2 to Day 5|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.|||Percentage of Participants|||Number
2654324|NCT01636947|Secondary|Percentage of Participants With One or More Clinical Adverse Event|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition, which is temporally associated with the use of the study drug, is also an adverse event. Nausea and vomiting experienced during Days 1-6 were not counted as adverse events unless they were reported as a serious adverse event.|Day 1 through Day 29 (Up to 28 days after first dose of study drug)|All randomized participants who received chemotherapy and took ≥1 dose of study drug.|||Percentage of Participants|||Number
2654325|NCT01636947|Secondary|Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages|The percentage of participants who used no rescue therapy after initiation of MEC is presented for the Overall, Acute and Delayed Stages. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC.|Day 1 to Day 5|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.|||Percentage of Participants|||Number
2654326|NCT01636947|Secondary|Percentage of Participants With No Impact on Daily Life - Overall Stage|"The Functional Living Index-Emesis questionnaire (FLIE) is a validated, participant-reported instrument to measure the impact of chemotherapy-induced nausea and vomiting on daily life. There are 9 nausea-related items and 9 vomiting-related items, each on a 7-point scale. For the purposes of this study, No Impact on daily life was defined as an average item score of >6 on the 7-point scale; a total score >108 indicates no impact on daily life. Overall Stage=0 to 120 hours after initiation of MEC."|Day 6|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug, had ≥1 post-treatment assessment on Day 1 and Day 2 and completed the FLIE questionnaire on Day 6.|||Percentage of Participants|||Number
2654327|NCT01636947|Secondary|Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage|"Nausea was to be assessed using a 100-mm horizontal visual analogue scale (VAS) located in the participant diary labeled: How much nausea have you had over the last 24 hours? The left end of the scale (0 mm) was labeled no nausea, and the right end of the scale (100 mm) is labeled nausea as bad as it could be. In this study, No Significant Nausea was defined as a VAS nausea rating <25 mm."|Days 1 to Day 5|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.|||Percentage of Participants|||Number
2654328|NCT01636947|Secondary|Number of Emetic Events - Overall Stage|The number of emetic events that occurred during the Overall Stage (0 to 120 hours after initiation of MEC) are presented.|Hour 0 on Day 1 to Day 5 (approximately 120 hours)|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.|||Number of Emetic Events|||Number
2654329|NCT01636947|Secondary|Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages|A Complete Response was defined as no vomiting or dry heaves and no use of a rescue therapy. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC.|Hour 0 on Day 1 to Day 5 (approximately 120 hours)|The mITT population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.|||Percentage of Participants|||Number
2654330|NCT01636947|Primary|The Percentage of Participants With No Vomiting - Overall Stage|A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). No vomiting during the Overall Stage was defined as no episodes of emesis during the 120 hours (Days 1-5) after initiation of moderately emetogenic chemotherapy (MEC).|Hour 0 on Day 1 to Day 5 (approximately 120 hours)|The modified intention-to-treat (mITT) population consisted of all randomized participants who received chemotherapy, took ≥1 dose of study drug and had ≥1 post-treatment assessment on Day 1 and Day 2.|||Percentage of Participants|||Number
2654331|NCT01636882|Primary|Safety|Participants with Grade 3 or Higher Adverse Events|12 months||||participants|||Number
2654332|NCT01636778|Secondary|Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler During Follow-up Period After Part 2|Abdominal ultrasound with doppler were taken during Follow-up Period after Part 2 at FU Week 24. Questions were asked to assess masses suspicious for HCC, ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and OCSF. Spleen measurements included spleen length and spleen width (breadth).|FU Week 24|SP2 Population.|||Cm||Standard Deviation|Mean
2654333|NCT01636778|Secondary|Spleen Measurements as Assessed by Abdominal Ultrasound With Doppler in the Study|Abdominal ultrasound with doppler were taken at Baseline, Week 24, Week 48, WD/comp. Questions were asked to assess masses suspicious for HCC, ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and OCSF. Spleen measurements included spleen length and spleen width (breadth).|Baseline; Week 24, Week 48, Withdrawal/Completion|SP1 Population. Only those participants available at the specified time points were analyzed (n=X).|||Centimeters (cm)||Standard Deviation|Mean
2654334|NCT01636778|Secondary|Number of Participants With Abdominal Ultrasound With Doppler During Follow-up Period After Part 2|Abdominal ultrasound with doppler were taken during Follow-up Period after Part 2 at FU Week 24. Questions were asked to assess masses suspicious for hepatocellular carcinoma (HCC), ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and other clinically significant findings (OCSF).|FU Week 24|SP2 Population.|||Participants|||Number
2654509|NCT01635439|Primary|Induction to Delivery Interval||24 hours||||hours||Standard Deviation|Mean
2654335|NCT01636778|Secondary|Number of Participants With Abdominal Ultrasound With Doppler at the Indicated Time Points|Abdominal ultrasound with doppler were taken at Baseline, Week 24, Week 48, withdrawal (WD)/completion (comp). Questions were asked to assess masses suspicious for hepatocellular carcinoma (HCC), ascites, portal vein thrombosis detected, possiblility to measure spleen breadth, and other clinically significant findings (OCSF).|Baseline; Week 24, Week 48, Withdrawal/Completion|SP1 Population. Only those participants available at the specified time points were analyzed (n=X).|||Participants|||Number
2654336|NCT01636778|Secondary|Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) During Follow-up After Part 2|The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal= all ECG parameters within accepted normal ranges. Abnormal= ECG findings outside of normal ranges. CS= ECG with a CS abnormality that meets exclusion criteria. NCS= ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.|FU Baseline and FU Week 24|SP2 Population.|||Participants|||Number
2654337|NCT01636778|Secondary|Number of Participants Assessed as Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points|The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal= all ECG parameters within accepted normal ranges. Abnormal= ECG findings outside of normal ranges. CS= ECG with a CS abnormality that meets exclusion criteria. NCS= ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.|Screening, Antiviral Baseline, Week 12, 24, 36, 48, Withdrawal|SP1 Population.|||Participants|||Number
2654338|NCT01636778|Secondary|Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points During Follow-up Period After Part 2|Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.|FU Baseline and FU Week 24|SP2 Population.|||Participants|||Number
2654339|NCT01636778|Secondary|Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part 2|Urinalysis parameters included: UB, UOB, UG, UK, pH, UP, USG and UU. The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as 1+, (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.|Antiviral Baseline,Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal|SP2 Population.|||Participants|||Number
2654340|NCT01636778|Secondary|Number of Participants With the Indicated Urinalysis Parameters Tested by Dipstick at the Indicated Time Points in Part1 With Follow Up Period|Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), pH, urine protein (UP), urine specific gravity (USG) and urine urobilinogen (UU). The dipstick test gives results in a semi-quantitative manner. UB was categorized as (-), negative (Neg). UOB was categorised as 1+, 2+, 3+, (-), Neg, trace. UG results were categorized as (-), 0.5, Neg. UK parameters were categorized as as (-), Neg. pH results were in the range of pH from 5-8.5 in increments of 0.5. UP was categorized as 1+, (-), Neg, trace. UU was categorized as 1+, 0.1, 1, 2, 4, Neg, trace, normal. USG results were in the range from 1.000-1.030 in increments of 0.001.|Screening, Baseline, Week 1, 2, 3, 4, 7, 8, Withdrawal, FU Week 24|SP1 Population.|||Participants|||Number
2654341|NCT01636778|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for Hematology Parameters Per DAIDS During Follow-up Period After Part 2|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From FU Week 4 to FU Week 24|SP2 Population,|||Participants|||Number
2654342|NCT01636778|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 2|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 2 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Antiviral Baseline up to Week 48|SP2 Population.|||Participants|||Number
2654343|NCT01636778|Secondary|Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters Per DAIDS in Part 1|Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL in Part 1 are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 9|SP1 Population.|||Participants|||Number
2654344|NCT01636778|Secondary|Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS During Follow-up Period After Part 2|Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From FU Week 4 to FU Week 24|SP2 Population.|||Participants|||Number
2654345|NCT01636778|Secondary|Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per DAIDS in Part 2|Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 2. Clinical chemistry parameters included albumin, ALP, ALT, AST, total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Antiviral Baseline up to Week 48|SP2 Population.|||Participants|||Number
2654346|NCT01636778|Secondary|Number of Participants With the Indicated Shift From Baseline in Severity Grades for Clinical Chemistry Parameters Per Division of Acquired Immunodeficiency Syndrome (DAIDS) in Part 1|Blood samples for the assessment of clinical chemistry parameters were taken at intervals in Part 1. Clinical chemistry parameters included albumin, alkaline phosphatase (ALP), ALT, aspartate amino transferase (AST), total bilirubin, calcium, creatinine, potassium, sodium, and uric acid. Per DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 0=none, 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.|From Baseline up to Week 9|SP1 Population.|||Participants|||Number
2654347|NCT01636778|Secondary|Mean BMI at the Indicated Time Points During Follow-up Period After Part 2|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared.|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population|||kilogram per meters squared (kg/m^2)||Standard Deviation|Mean
2654348|NCT01636778|Secondary|Mean Change From Baseline in BMI at the Indicated Time Points in Part 2|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2 Population.|||kg/m^2||Standard Deviation|Mean
2654349|NCT01636778|Secondary|Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points in Part 1 With Follow-up Periodc|The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24|SP1 Population.|||kilogram per meters squared (kg/m^2)||Standard Deviation|Mean
2654350|NCT01636778|Secondary|Mean Body Temperature at the Indicated Time Points During Follow-up Period After Part 2|The Body temperature of participants was recorded at the indicated time points..|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population|||Degrees centigrade||Standard Deviation|Mean
2654351|NCT01636778|Secondary|Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 2|The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2 Population.|||Degrees centigrade||Standard Deviation|Mean
2654352|NCT01636778|Secondary|Mean Change From Baseline in Body Temperature at the Indicated Time Points in Part 1 With Follow-up Period|The Body temperature of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24|SP1 Population.|||Degrees centigrade||Standard Deviation|Mean
2654353|NCT01636778|Secondary|Mean Weight at the Indicated Time Points During Follow-up Period After Part 2|The weight of participants was recorded at the indicated time points.|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population|||kg||Standard Deviation|Mean
2654354|NCT01636778|Secondary|Mean Change From Baseline in Weight at the Indicated Time Points in Part 2|The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|Baseline; Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2 Population.|||kg||Standard Deviation|Mean
2654355|NCT01636778|Secondary|Mean Change From Baseline in Weight at the Indicated Time Points in Part 1 With Follow-up Period|The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24|SP1 Population.|||Kilogram (kg)||Standard Deviation|Mean
2654356|NCT01636778|Secondary|Mean Heart Rate at the Indicated Time Points During Follow-up Period After Part 2|The heart rate was measured in participants at the indicated time points.|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population.|||bpm||Standard Deviation|Mean
2654357|NCT01636778|Secondary|Mean Change From Antiviral Baseline in Heart Rate at the Indicated Time Points in Part 2|The heart rate was measured in participants at the indicated time points. Mean change from Antiviral Baseline was calculated as the value at the indicated time points minus the value at Antiviral Baseline.|Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2 Population.|||bpm||Standard Deviation|Mean
2654358|NCT01636778|Secondary|Mean Change From Baseline in Heart Rate at the Indicated Time Points in Part 1 With Follow-up Period|The heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, FU Week 24|SP1 Population.|||Beats per minute (bpm)||Standard Deviation|Mean
2654359|NCT01636778|Secondary|Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During Follow-up Period After Part 2|Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed.|FU Baseline, FU Week 4, FU Week 12 and FU Week 24 after Part 2|SP2 Population.|||mmHg||Standard Deviation|Mean
2654510|NCT01635244|Primary|Aortic Valve Mean Gradient (mm Hg) at Peak Exercise|This is a measure of the resistance to flow across the aortic bioprosthesis.|6 months after aortic valve replacement||||mm Hg||Inter-Quartile Range|Median
2654360|NCT01636778|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 2|Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Antiviral Baseline,Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|SP2: consisted of all participants who were enrolled in Part 2 and received at least one dose of eltrombopag.|||mmHg||Standard Deviation|Mean
2654361|NCT01636778|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points in Part 1 With Follow-up Period|Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline|Baseline; Week 1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1 and FU Week 4, FU Week 12, and FU Week 24|SP1|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2654362|NCT01636778|Secondary|Number of Participants With Any AE and Any SAE During Follow-up Period After Part 2|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.|From FU Baseline up to FU Week 24 after Part 2|SP2 Population|||Participants|||Number
2654363|NCT01636778|Secondary|Number of Participants With Any AE and Any SAE in Part 2|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.|From Antiviral Baseline up to Week 48 in Part 2|Safety Population 2 (SP2): consisted of all participants who were enrolled in Part 2 and received at least one dose of eltrombopag.|||Participants|||Number
2654364|NCT01636778|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part1|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect.|From Baseline up to week 9 in Part 1|Safety Population 1 (SP1) : consisted of all participants who were enrolled in Part 1 and received at least one dose of eltrombopag.|||Participants|||Number
2654365|NCT01636778|Secondary|Mean Serum HCV RNA at the Indicated Time Points During Follow-up Period After Part 2|The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at FU Baseline, FU Week 12 and FU Week 24 during Follow-up Period after Part 2|FU Baseline, FU Week 12 and FU Week 24 after Part 2|FAS2 Population. Participants with any antiviral drugs during follow-up period after Part 2 were excluded from this analysis.|||Log international unit per milliliter||Standard Deviation|Mean
2654366|NCT01636778|Secondary|Mean Serum HCV RNA at the Indicated Time Points In Part 2|The HCV is a small, enveloped, single-stranded, positive-sense RNA virus. Log-Transformed HCV RNA was assessed at Screening, Antiviral Baseline, Part 2 week 4, 12, 24, 36, 48 and at withdrawal.|Screening, Antviral baseline; Week 4, 12, 24, 36, 48, Withdrawal in Part 2|FAS2 Population.|||Log international unit per milliliter||Standard Deviation|Mean
2654367|NCT01636778|Secondary|Number of Participants With End of Treatment Response (ETR) for Undetectable HCV RNA at the End of Peg-IFN/RBV Treatment in Part 2|ETR is defined as undetectable HCV RNA at the end of Peg-IFN/RBV treatment.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.|||Participants|||Number
2654368|NCT01636778|Secondary|Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) in Part 2|EVR is defined as a clinically significant reduction from Baseline in HCV RNA (>=2 log10 decrease in HCV RNA or undetectable HCV RNA) after 12 weeks of antiviral treatment. cEVR, a subset of EVR, is defined exclusively as undetectable HCV RNA after 12 weeks of antiviral treatment.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.|||Participants|||Number
2654369|NCT01636778|Secondary|Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) in Part 2|RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA between 4 weeks and 12 weeks after antiviral treatment.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.|||Participants|||Number
2654370|NCT01636778|Secondary|Number of Participants With Sustained Virologic Response (SVR) in Part 2|Participants with SVR were defined as those with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of treatment period Part 2|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.|||Participants|||Number
2654371|NCT01636778|Secondary|Number of Participants Achieving Adherence to Peg-IFN Alpha-2b Antiviral Therapy in Part 2|Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alpha-2b and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who received Peg-IFN alpha-2b antiviral therapy were analyzed.|||Participants|||Number
2654372|NCT01636778|Secondary|Number of Participants Achieving Adherence to Peg-IFN Alpha 2a Antiviral Therapy in Part 2|Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa-2a and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who received Peg-IFN alpha-2a antiviral therapy were analyzed.|||Participants|||Number
2654373|NCT01636778|Secondary|Number of Participants Achieving Adherence to Antiviral Therapy in Part 2|Adherence to antiviral therapy was defined as receiving at least 80% of the prescribed dose (investigator prescribed) of Peg-IFN alfa and at least 80% of the prescribed dose (investigator prescribed) of RBV, for at least 80% of the planned duration|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.|||Participants|||Number
2654374|NCT01636778|Secondary|Number of Participants Who Discontinued Peg-IFN Alpha-2b Therapy in Part 2|Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2b therapy was assessed up to 48 weeks in Part 2|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who received Peg-IFN alpha-2b antiviral therapy were analyzed.|||Participants|||Number
2654375|NCT01636778|Secondary|Number of Participants Who Discontinued Peg-IFN Alpha-2a Therapy in Part 2|Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Peg-IFN alpha-2a therapy was assessed up to 48 weeks in Part 2|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who received Peg-IFN alpha-2a antiviral therapy were analyzed.|||Participants|||Number
2654376|NCT01636778|Secondary|Number of Participants Who Discontinued Antiviral Therapy in Part 2|Dosing discontinuation is defined as the occurrence of stopping the medication. Dosing discontinuation of Antviral Therapy was assessed up to 48 weeks in Part 2|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.|||Participants|||Number
2654377|NCT01636778|Secondary|Time to First Dose Reduction of Antiviral Therapy in Part 2|Time to first dose reduction was calucated as the time period from the first dose to the first dose reduction.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.|||weeks||Standard Deviation|Mean
2654378|NCT01636778|Secondary|Number of Participants With the Indicated Levels of RBV Therapy Dose Reductions in Part 2|Participants were assigned a score equal to the number of times their RBV dose of antiviral therapy was reduced (0=no DRs; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of RBV|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.|||Participants|||Number
2654379|NCT01636778|Secondary|Number of Participants With the Indicated Levels of Peg-IFN Alpha-2b Therapy Dose Reductions in Part 2|Participants were assigned a score equal to the number of times their Peg-IFN alpha-2b dose of antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who met the criteria for antiviral therapy dose reduction of Peg-IFN alpha-2b were analyzed.|||Participants|||Number
2654380|NCT01636778|Secondary|Number of Participants With the Indicated Levels of Peg-IFN Alpha-2a Therapy Dose Reductions in Part 2|Participants were assigned a score equal to the number of times their Peg-IFN alpha-2a dose of antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population. Only those particpants who met the criteria for antiviral therapy dose reduction of Peg-IFN alpha-2a were analyzed.|||Participants|||Number
2654381|NCT01636778|Secondary|Number of Antiviral Therapy Dose Reductions in Part 2|Number of reductions in Part 2 of either Peg-IFN or RBV. Participants were assigned a score equal to the number of times antiviral therapy was reduced (0=no dose reductions [DRs]; 1=one DR; 2=two DRs; 3=three DRs; >3=more than three DRs). Where possible, every effort was made to maintain the recommended dose of antiviral therapy. However, where dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of Peg-IFN and/or RBV.|From Antiviral Baseline up to Week 48 in Part 2|FAS2 Population.|||Participants|||Number
2654382|NCT01636778|Secondary|Dose of Eltrombopag That Enabled Initiation of Antiviral Therapy|Participants received eltrombopag at escalating dosages until a platelet count of >=100 Gi/L was achieved in Part 1. Platelet counts were measured by blood draw.|From Baseline up to Week 9 in Part 1|FAS1 Population: all participants enrolled in Part 1.|||Participants|||Number
2654383|NCT01636778|Secondary|Minimum Platelet Count on Antiviral Therapy|"Participants were assessed for platelet counts during antiviral therapy in Part 2.~Platelet counts were measured by blood draw."|From Antiviral Baseline to up to Week 48 in Part 2|FAS2 Population: all participants enrolled in Part 2.|||Participants|||Number
2654384|NCT01636778|Secondary|Median Platelet Count at the Indicated Time Points During Follow-up Period After Part 2|Platelet counts were measured by blood draw at specified timepoints.|Follow-up (FU) Baseline, FU Week 4, FU Week 12 and and FU Week 24 after Part 2|FAS2 Population. Participants with any antiviral drugs during follow-up period after Part 2 are excluded from this analysis.|||Gi/L||Full Range|Median
2654385|NCT01636778|Secondary|Median Platelet Count at the Indicated Time Points in Part 2|Platelet counts were measured by blood draw|Antiviral Baseline, Week 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, Withdrawal in Part 2|FAS2 Population.|||Gi/L||Full Range|Median
2654386|NCT01636778|Secondary|Time in Weeks to Achieve Platelet Count >= 100 Gi/L|Participants were assessed for achieving platelet counts >=100 Gi/L during Part 1. Platelet counts were measured by blood draw.|From Baseline up to Week 9 in Part 1|FAS1 Population: all participants enrolled in Part 1.|||Participants|||Number
2654387|NCT01636778|Secondary|Median Platelet Count at the Indicated Time Points in Part 1|Platelet counts were measured by blood draw|Baseline, Week1, 2, 3, 4, 5, 6, 7, 8, 9, Withdrawal in Part 1|FAS1 Population.|||10^9 Cells Per Liter (Gi/L)||Full Range|Median
2654389|NCT01636778|Primary|Number of Participants Whose Platelet Count Increased From a Baseline Count of < 80 Gi/L to a Count >=100 Gi/L During Part 1|Participants were assessed for a shift from a baseline platelet count of <80 Gi/L to a count >=100 Gi/L during Part 1(up to 9 weeks). Platelet counts were measured by blood draw.|From Baseline up to Week 9 in Part 1|Full Analysis Set 1 (FAS1) Population: all participants enrolled in Part 1.|||Participants|||Number
2654390|NCT01636765|Primary|Intra-rater Reliability of the CEA Scale|Intra-rater (within raters) agreement of the CEA scores (0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness; 4=severe erythema, fiery redness) was evaluated by weighted Kappa statistics (WKS). WKS were calculated for each of 7 raters who evaluated 104 participant's severity of erythema of rosacea using the CEA scale, assessing agreement between 2 different time points at day 1. The overall intra-rater agreement for WKS for all raters combined was estimated by pooling WKS for each rater using a chi-square statistic. The degree of agreement of the point estimates of WKS was interpreted according to the reference range scale that was predefined as: ≤ 0=poor, 0.00-0.20=slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial and 0.81-1.00=almost perfect. The 95% confidence interval for Kappa statistics was provided.|Day 1|All enrolled participants.|||Kappa statistics||95% Confidence Interval|Mean
2654391|NCT01636765|Primary|Inter-rater Reliability of the Clinician Erythema Assessment (CEA) Scale|Inter-rater agreement (among raters) of the CEA scores (0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness; 4=severe erythema, fiery redness) evaluated using Kendall's coefficient of concordance (Kendall's W). Each of 7 raters scored 104 participant's severity of erythema due to rosacea using the CEA Scale at 2 different time points at day 1. The overall inter-rater agreement for Kendall's W for all raters combined was estimated based on the average of the scores from those 2 different time points. The degree of agreement of the point estimates of Kendall's W was interpreted according to the reference range scale that was pre-defined as: ≤ 0=poor, 0.00-0.20=slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial and 0.81-1.00=almost perfect. The 95% confidence interval for Kendall's W was provided.|Day 1|All enrolled participants.|||Kendall's W||95% Confidence Interval|Mean
2654392|NCT01636713|Secondary|Change From Baseline Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 1|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated using the 0-6-hour post-dose FEV1 measurements collected on Day 1, which included pre-dose (30 minutes [min] and 5 min prior to dosing) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from Baseline at Day 1was calculated as the WM at post -dose value on Day 1 minus Baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1). Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, Baseline FEV1 (mean of the two assessments made 30 and 5 minutes pre-dose on Day 1), smoking status, and country/region.|Baseline and Day 1|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
2654393|NCT01636713|Secondary|Transition Dyspnea Index (TDI) Focal Score at Day 168 (Week 24)|The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. This questionnaire was collected on Days 28, 84 and 168. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9. Analysis was performed using a repeated measures model with covariates of treatment, Baseline dyspnea index (BDI) focal score, smoking status, country/region, day, day by Baseline dyspnea index (BDI) focal score and day by treatment interactions.|Day 168 (Week 24)|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Scores on a scale||Standard Error|Least Squares Mean
2654394|NCT01636713|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline, smoking status, country/region, day, day by Baseline and day by treatment interactions. par.=participants.|Baseline and Day 169|Intent-to-Treat (ITT) Population: all par. randomized to trt. who received at least one dose of randomized study drug. Par. represents those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
2654395|NCT01636687|Secondary|Number of Participants Developing Treatment-emergent Anti-secukinumab Antibodies|The development of anti-secunimubab anti-bodies decreases a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to week 216.|Baseline and at Week 12, 24, 52, 100, 148, 196, 208, and 216|FAS|||Number of participants|||Number
2654396|NCT01636687|Secondary|Percentages of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 160|Full analysis set (FAS).|||Percentages of participants|||Number
2654397|NCT01636687|Secondary|Absolute Change From Baseline for PASI Score After Week 52 (Observed Data)|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4).|Week 160|Full analysis set (FAS).|||Units on a scale||Standard Deviation|Mean
2654398|NCT01636687|Secondary|Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response After Week 52 (Observed Data)|"PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline.~The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe."|Week 160|Full analysis set (FAS). Results after Week 160 and beyond cannot be interpreted meaningfully due to low number of evaluable patients at these visits.|||Percentages of participants|||Number
2654399|NCT01636687|Secondary|Percentages of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52 - (Maintenance)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions."|Week 52|Full Analysis Set (FAS) - All patients to whom study treatment was assigned.|||Percentage of participants|||Number
2654400|NCT01636687|Secondary|Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12 - Induction Period|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions."|Week 12|Full analysis set (FAS)|||Percentage of participants|||Number
2654401|NCT01636687|Secondary|Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52 - Maintenance Period|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.~A negative median percent change from baseline indicates improvement."|Baseline, Week 52|Full Analysis Set (FAS)|||Percent change||95% Confidence Interval|Median
2654402|NCT01636687|Secondary|Percentage Changes From Baseline in Dermatology Life Quality Index (DLQI) Score - Induction Period|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions.~A negative median percent change from baseline indicates improvement."|Baseline, up to Week 12|Full Analysis Set (FAS)|||percent change||95% Confidence Interval|Median
2654403|NCT01636687|Secondary|Change From Baseline in EQ-5D Over Time up to Week 52 - Maintenance Period|"ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example confined to bed) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)."|Week 52|Full Analysis Set (FAS)|||unit on a scale||Standard Deviation|Mean
2654404|NCT01636687|Secondary|Change From Baseline in EQ-5D up to Week 12 - Induction Period|"ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example confined to bed) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)."|Week 12|Full Analysis Set (FAS)|||unit on a scale||Standard Deviation|Mean
2654405|NCT01636687|Secondary|Percentages of Participants in Each IGA Mod 2011 Category Over Time up to Week 52 - Maintenance Period (Observed Data)|The Investigators' Global Assessment (IGA) mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 52|Full Analysis Set (FAS)|||Percentages of participants|||Number
2654406|NCT01636687|Secondary|Percentage of Participants in Each IGA Mod 2011 Category - Induction Period|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe|Week 12|Full Analysis Set (FAS) - All patients to whom study treatment was assigned.|||Percentages of participants|||Number
2654407|NCT01636687|Secondary|Absolute Change From Baseline for PASI Score Over Time up to Week 52 - Maintenance Period (Observed Data)|Psoriasis Area and Severity Index (PASI): Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4).|Baseline, Week 52|Full Analysis Set (FAS)|||Units on a scale||Standard Deviation|Mean
2654408|NCT01636687|Secondary|Absolute Change From Baseline for PASI Score - Induction Period|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)|Baseline, Week 12|Full Analysis Set (FAS)|||Units on a scale||Standard Deviation|Mean
2654409|NCT01636687|Secondary|Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Maintenance Period (Observed Data)|"PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline.~The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe."|Week 12 up to Week 52|Full Analysis Set (FAS). Results after Week 160 and beyond cannot be interpreted meaningfully due to low number of evaluable patients at these visits.|||Percentages of participants|||Number
2654410|NCT01636687|Secondary|Percentages of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 Response - Induction Period|"PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline.~The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe."|Week 12|Full Analysis Set (FAS)|||Percentages of participants|||Number
2654411|NCT01636687|Secondary|Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48|"The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10; 0 corresponds to worst experience while 10 corresponds to best experience. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit."|Absolute change from baseline at week 48|Safety set|||Score||Standard Deviation|Mean
2654412|NCT01636687|Secondary|Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12|"The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10; 0 corresponds to worst experience while 10 corresponds to best experience. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit."|Week 12|Safety Set|||Score||Standard Deviation|Mean
2654413|NCT01636687|Secondary|Percentage of Subjects With Possible Use-related Hazards|To assess potential use-related hazards with the secukinumab autoinjector for the subject.|Week 1|Safety set|||Percentages of participants|Participants||Number
2654414|NCT01636687|Secondary|Percentages of Subjects With Successful Self-administration of Study Drug at Week 1|To assess the subject's ability to follow instructions for use with the secukinumab autoinjector|Week 1|Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received.|||Percentages of participants|||Number
2654415|NCT01636687|Primary|Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response|"Efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis.~PASI score was based on assessment of the head, trunk, upper limbs and lower limbs for erythema, thickening (plaque elevation, induration), and scaling (desquamation). PASI scores can range from 0, corresponding to no signs of psoriasis, up to a theoretical maximum of 72.0. PASI-based secondary variables included absolute PASI score, response rates for PASI 75. PASI 50 and PASI 90 were defined as ≥ 50% and ≥ 90% improvement from Baseline in PASI score, respectively, while PASI 100 response corresponded to complete clearing of psoriasis (PASI = 0). IGA mod 2011 was used to evaluate the overall severity of psoriatic disease, with scores ranging from 0 (clear) to 4 (severe). Treatment success was defined as achievement of IGA mod 2011 0 or 1 score."|12 weeks|Full Analysis Set (FAS) comprises of all patients to whom study treatment has been assigned.|||Percentages of participants|||Number
2654416|NCT01636661|Secondary|Hand Function Decline as Measured by Number of Participants|Measured by the Box and Blocks Test and Grip Strength|Baseline, Posttest, Follow-Up Session at One-Week||||participants|||Number
2654417|NCT01636661|Primary|Adverse Events/Safety Assessment.|"Assessment of safety of use of tDCS in children with hemiparesis through vital signs, physician evaluation, subject report of symptoms. Reported are the number of participants who met the following criteria:~Vital Signs (either resting blood pressure or heart rate)- Any greater than 2SD of change in vital signs from pretest to posttest.~Physician Evaluation- Child identified as declining in function from pretest to posttest.~Subject Report of Symptoms- Reports of serious adverse event/symptoms from pretest to posttest.~Detailed adverse events are reported in the adverse events module."|Baseline, Posttest, Follow-Up Session at One-Week|Pilot study therefore no sample size analysis. Completed per protocol.|||Participants|||Number
2654418|NCT01636466|Secondary|Incidence of Return to Dialysis Dependence||36 months|Single subject enrolled was terminated early. Data analysis was not performed as the Month 36 visit did not occur.||||||
2654419|NCT01636466|Primary|Mean Fluorescence Index (MFI) of Donor Specific Alloantibodies (DSA)|Development of new donor-specific alloantibody as determined by solid phase bead array (Luminex) technology defining MFIs for fine specificity at Class I and Class II antigens (human leukocyte antigens (HLA) - A, B, C, DR, DP, and DQ) with an MFI >5000 defined as positive|36 months|Single subject enrolled was terminated early. Data analysis was not performed as the Month 36 visit did not occur.||||||
2654420|NCT01636453|Secondary|Number of Participants Who Experienced Aneurysm Recanalization||At 12 months post-implant||||Participants|||Count of Participants
2654421|NCT01636453|Secondary|Number of Participants Who Experienced Device Patency|Device patency (stenosis) at 12 months|at 12 months post-implant||||Participants|||Count of Participants
2654422|NCT01636453|Secondary|Number of Retreatments|Defined as any intervention after the completion of the initial stent assisted coiling procedure|At 12 months post-implant||||Participants|||Count of Participants
2654423|NCT01636453|Secondary|All Cause Mortality (Number of Deaths From Any Cause)||At 12 months post-implant||||Participants|||Count of Participants
2654424|NCT01636453|Secondary|Number of Participants With Functional Outcome as Defined by the Modified Rankin Scale (mRS) 0-2|The Modified Rankin Scale measures functional ability on a scale from 0-5, with 0 indicating no symptoms at all and 5 indicating severe disability.|At 12 months post-implant||||Participants|||Count of Participants
2654425|NCT01636453|Secondary|Number of Intracranial Hemorrhages|Inclusive of subarachnoid, intraventricular or intraparenchymal hemorrhages (symptomatic or asymptomatic). Symptomatic is defined as a 4 point or more increase in the National Institutes of Health Stroke Scale (NIHSS) from baseline. The NIHSS ranges from 1 to 42, with higher scores indicating greater severity of stroke.|At 12 months post-implant||||Participants|||Count of Participants
2654426|NCT01636453|Secondary|Number of Participants With Aneurysm Raymond Class I Occlusion Grading|Raymond Class I Occlusion grading defined as complete obliteration of the aneurysm at 12 months.|At 12 months post-implant||||Participants|||Count of Participants
2654427|NCT01636453|Secondary|Number of Device Migrations|Migration is defined as movement of the Liberty stent by more than 5 mm as documented by the 12 month angiogram when compared to its immediate post-implant position.|12 months post-implant||||Participants|||Count of Participants
2654428|NCT01636453|Secondary|Number of Device Deployment Failures|Defined by the failure of the device to deploy or failure to correctly position the device over the aneurysm|During the procedure||||Participants|||Count of Participants
2654429|NCT01636453|Secondary|Number of Participants With Device-related Serious Adverse Events|The number of participants with device-related Serious Adverse Events as a measure of safety of the procedure and device. The FDA definitions for Serious Adverse Events are used.|During the procedure||||Participants|||Count of Participants
2654430|NCT01636453|Secondary|Number of Ipsilateral Ischemic Strokes|Defined as episodes of focal or global neurological dysfunction due to brain or retinal infarction in the same hemisphere of the target aneurysm with signs and symptoms that persist for 24 hours or longer. When appropriate, non contrast CT scans will be used to eliminate hemorrhagic strokes|At 12 months post-implant||||participants|||Number
2654431|NCT01636453|Primary|Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment.||At 12 months post-implant||||Participants|||Count of Participants
2654432|NCT01636453|Primary|Number of Participants With Raymond Class I Complete Obliteration at 12 Months|Complete aneurysmal obliteration is defined by the method of Raymond et al. (Class I) (Stroke 2001;32:1998-2004).|At 12 months post-implant||||Participants|||Count of Participants
2654433|NCT01636414|Primary|Change in Hemoglobin Level|Change in hemoglobin following surgery. Initial (baseline) measure was prior to surgery on day of surgery. Follow-up measurement occurred the day following surgery.|Post-operative on day 2 (first day after surgery)||||g/dl||Inter-Quartile Range|Median
2654434|NCT01636414|Primary|Blood Transfusion|Transfusion Rate (i.e, number of participants needing Blood Transfusion) Between Treatment Groups|Inpatient Postoperative, on average 3 days after surgery||||participants|||Number
2654435|NCT01636362|Secondary|Percent of Study Burn Healed.|Percent of study burn healed measured by PictZar photo analysis of tissue types.|At day 21||||percentage of healing||Full Range|Median
2654436|NCT01636362|Primary|Proportion of Subjects Healed at Day 21.|The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21.|Healing will be assessed after 21 days.||||participants|||Number
2654437|NCT01636362|Primary|Number of Subjects Healed at Day 14.|> = 95 % epitheliazation|Healing will be assessed after 14 days.||||participants|||Number
2654438|NCT01636297|Primary|Number of Participants With Increased Motor Cortex and Thalamus Connectivity|The primary outcome measure will number of patients that increased their connection between the motor cortex and the thalamus. The functional connection was assessed using functional magnetic resonance imaging. The outcome measure was change in connectivity from baseline to end of treatment.|Change from baseline to end of treatment|A subgroup of participants from only the exercise groups were analyzed for this outcome measure, as not all participants in this study received functional MRI's. The No Exercise group was not included in this subgroup analysis and did not receive MRI.|||Participants|||Count of Participants
2654523|NCT01635062|Secondary|Change in Renal Plasma Flow After Calcitriol/Placebo Therapy|Subjects had their renal plasma flow assessed at baseline while sodium loaded, and again after 3 weeks of randomized therapy with either calcitriol (up to 0.75 mcg daily) or placebo.|baseline and 3 weeks following calcitriol/placebo therapy||||mL/min/1.73m2||Standard Deviation|Mean
2654439|NCT01636297|Primary|Trail Making Test|The Trail Making test is a test of executive function and the primary outcome is total test time. The total time that it takes to complete the test was recorded at baseline and then after the end of treatment. Test time recording begins with the start of the test and ends when the test is completed. Longer times indicate worse executive function. The outcome is the change in test time on the trail making test from baseline to the end of treatment (EOT) assessment.|Change from baseline over 16 weeks||||seconds||Standard Deviation|Mean
2654440|NCT01636297|Primary|MDS-UPDRS Motor III Score|The Movement Disorder Society-Unified Parkinson's disease Rating Scale (MDS-UPDRS) Motor III Score is a subscale of the MDS-UPDRS. The MDS-UPDRS III is the sum of 33 scores that evaluate Parkinson's disease motor symptoms on a scale from 0 to 4 points. A score of 0 indicated no symptom is present and a maximum score of 4 indicates the most severe symptom, the total scale range is 0-132, where higher scores indicate more severe symptoms. The primary outcome is the change in total motor subscale score in the MDS-UPDRS from baseline versus the three end of treatment (EOT) assessments.|Change from baseline over 16 weeks||||change in MDS- UPDRS III score||95% Confidence Interval|Mean
2654441|NCT01636258|Secondary|Sleep|Change in self-reported average hours of sleep/night measured at baseline and followup (at 8-14 weeks).|baseline and followup visit (at 8-14 weeks)||||hours/night||Inter-Quartile Range|Mean
2654442|NCT01636258|Secondary|Stress|Change of Psychosocial Stress (PSS-10) scores (total range 0-40) measured at baseline and followup (at 8-14 weeks). Higher score reflects worse outcome.|baseline and followup visit (at 8-14 weeks)||||scores on a scale||Inter-Quartile Range|Mean
2654443|NCT01636258|Secondary|Exercise|Change in 7-day average steps/day as measured by pedometer at baseline and followup (at 8-14 weeks).|Baseline and final followup visits (at 8-14 weeks)||||steps/day||Inter-Quartile Range|Mean
2654444|NCT01636258|Secondary|Diet - Daily Calorie Intake|Change in daily caloric intake as measured by online 24-hour recall dietary program|Baseline and final followup visit (at 8-14 weeks)||||Kcal/day||Inter-Quartile Range|Mean
2654445|NCT01636258|Primary|"Effect of FRESH Program on Weight Loss"|Change in weight measured at baseline and followup (at 8-14 weeks).|Baseline line and final followup visit (at 8-14 weeks)||||kg||Standard Deviation|Mean
2654446|NCT01636206|Primary|Number of Participants With Ocular and Nonocular Treatment Emergent Adverse Events (TEAEs) for 1 Year||Day 0 to Day 360|Safety population included all randomized participants who received at least 1 dose of investigational product.|||participants|||Number
2654447|NCT01636102|Secondary|Numbers of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 - Day 4 Postvaccination)|Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 up to and including day 4 after the TIV vaccination.|From day 1 through day 4 postvaccination|Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
2654448|NCT01636102|Primary|Percentage of Subjects Who Achieved SRH Area ≥25 mm2 Against Each of Three Vaccine Strains After One Vaccination of TIV|"Immunogenicity was measured as the percentage of subjects achieving SRH area ≥25 mm2 against each of three vaccine strains at baseline (day 1) and three weeks after TIV vaccination (day 22).~This criterion was met according to CHMP guideline if percentage of subjects achieving SRH area ≥25 mm2 is >70% (≥18 years to ≤60) or 60% (≥61 years)."|Day 1 and 22|Analysis was done on the PP set.|||Percentages of subjects||95% Confidence Interval|Number
2654449|NCT01636102|Primary|Geometric Mean Ratio of Subjects Against Each of Three Vaccine Strains After One Vaccination of TIV|"Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination SRH geometric mean areas (GMAs), directed against each of three vaccine strains, three weeks after vaccination (day 22).~The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.5 (≥18 years to ≤60 years) or >2.0 (≥61 years)."|Day 22|Analysis was done on the PP set.|||Ratio||95% Confidence Interval|Number
2654450|NCT01636102|Primary|Percentage of Subjects Who Achieved Seroconversion or Significant Increase in SRH Area Against Each of Three Vaccine Strains After One Vaccination of TIV|"Immunogenicity was measured as the percentage of subjects who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay.~Seroconversion or significant increase in SRH area was defined as the percentage of subjects with a negative prevaccination serum (SRH area ≤4 mm2) to a postvaccination SRH area ≥25 mm2; or a significant increase in antibody titer from a non-negative prevaccination serum, i.e., at least a 50% increase in area. The European (CHMP) criterion is met if percentage of subjects achieving seroconversion or significant increase in SRH area is >40% (≥18 years to ≤60 years) or 30% (≥61 years)."|Day 22|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||Percentages of subjects||95% Confidence Interval|Number
2654451|NCT01636076|Secondary|Pharmacokinetic Parameter--AUC0-t|"Area under the plasma concentration time curve from time zero to time t post-dose is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84."|Day 28, 84|Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.|||hr*pg/mL||Standard Deviation|Mean
2654452|NCT01636076|Secondary|Pharmacokinetic Parameter--Tmax|Time to reach the maximum plasma concentration after drug administration is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.|Day 28, 84|Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.|||Hr||Full Range|Median
2654453|NCT01636076|Secondary|Pharmacokinetic Parameter: Cmax|Maximum observed plasma concentration after drug administration is to be measured in a subset of approximately 60 patients via central laboratory, and will be determined for indacaterol and MF following morning dosing on Days 28 and 84.|Day 28, 84|Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.|||pg/mL||Standard Deviation|Mean
2665365|NCT01534208|Primary|Absolute Values of Morning Testosterone|Absolute values of morning testosterone at end of treatment (26 weeks)|6 months|ITT|||ng/dL||Standard Deviation|Mean
2654454|NCT01636076|Secondary|Plasma Drug Concentrations (Pharmacokinetics) at Each Timepoint|Plasma indacaterol and mometasone furoate is to be measured in a subset of approximately 60 patients via central laboratory. Blood samples are collected at pre-dose on Day 1, 29, and 84; and post dose up to 4 hour on Day 1, up to 12 hours on Day 28 and 84. For sparse pharmacokinetic testing, blood samples will be collected at 23h 35 min post-dose following morning dose administration on Day 28 and 84, in all patients participating in this study.|Day 1, 29, 84|Moderate PK set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.|||pg/mL||Standard Deviation|Mean
2654455|NCT01636076|Secondary|Plasma Cortisol Concentrations at Each Timepoint|Plasma cortisol to be measured in a subset of approximately 60 patients via central laboratory. Blood sample for Plasma cortisol is collected at pre-dose and post dose up to 4 hour on Day 1, up to 12 hours post-dose on Day 28 and Day 84, and 23 hour 35 minute on Day 2, Day 29, and Day 85, and at pre-dose 25 minute on Day 28, and Day 84.|Day 1, Day 28, Day 84|Safety set: A total of 97 (15.4%) patients were included in the 24 h profiling FAS, safety plasma cortisol profiling subgroup, sparse and moderate PK sets.|||nmol/mL||Standard Deviation|Mean
2654456|NCT01636076|Secondary|Total Amount (in Doses) of Systemic Corticosteroid Used to Treat COPD Exacerbation During the 12 Week Treatment Period|Total amount (in doses) of systemic corticosteroid used to treat COPD exacerbation will be summarized descriptively by treatment group per each systemic corticosteroid.|12 weeks|Full analysis set consisting of all randomized patients|||(Prednisolone dose equivalents) mg||Standard Deviation|Mean
2654457|NCT01636076|Secondary|The Percentage of Patients Who Permanently Discontinued Due to COPD Exacerbation|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.|12 weeks|Full analysis set consisting of all randomized patients|||Percentage participants|||Number
2654458|NCT01636076|Secondary|Time (in Days) to Permanent Study Discontinuation Due to COPD Exacerbation|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.|12 weeks|Full analysis set consisting of all randomized patients|||Days||Inter-Quartile Range|Median
2654459|NCT01636076|Secondary|Percentage of Patients With at Least One Exacerbation up to Week 12|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates. The reported measure will detail the percentage of participants that had an exacerbation up to week 12. Less exacerbations reflect a better outcome.|12 weeks|Full analysis set consisting of all randomized patients|||Percentage of participants|||Number
2654460|NCT01636076|Secondary|Duration (in Days) of COPD Exacerbations|Duration and number of the COPD exacerbation will be analyzed by the negative binomial regression model including treatment, country, smoking status, and COPD severity as factors and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.|12 weeks|Full analysis set consisting of all randomized patients|||Days||Standard Deviation|Mean
2654461|NCT01636076|Secondary|Annual Rate of COPD Exacerbations|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates.|12 weeks|Full analysis set consisting of all randomized patients|||COPD Exacerbations per year||95% Confidence Interval|Number
2654462|NCT01636076|Secondary|Time to First COPD Exacerbation|Time-to-event variables will be analyzed by the Kaplan-Meier estimates and the stratified Cox proportional hazard model by smoking status and COPD severity. The model will include treatment and country as factors, and FEV1 prior to inhalation and FEV1 15 min post inhalation of salbutamol/albuterol as covariates. The reported measure will detail the percentage of participants that were event free of a specified event.|12 weeks|Full analysis set consisting of all randomized patients|||Percentage of participants event free||95% Confidence Interval|Number
2654463|NCT01636076|Secondary|Summary Statistics of COPD Exacerbations over12 Weeks as Defined by Chronic Pulmonary Disease Tool (EXACT)|The EXACT is a 14-item electronic questionnaire designed to detect the frequency, severity, and duration of exacerbations in patients with COPD.|12 weeks|Full analysis set consisting of all randomized patients|||COPD exacerbation per participant||Standard Deviation|Mean
2654464|NCT01636076|Secondary|Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Sleep Quantity Subscale|The sleep quantity subscale,which refers to question 2 of the PRO: On average, how many hours did you sleep each night during the past 4 weeks. More hours of sleep indicate better outcome.|Baseline, 4 and 12 weeks|Full analysis set.Higher scores show better outcomes.Excepting the sleep quantity subscale,scoring the MOS requires two steps:(a) assigning a point value to each response and (b) summing the point values for all the items in a given subscale or index. Each subscale and index score is then converted to a T score with a mean of 50 and an SD of 10.|||hours of sleep||Standard Deviation|Mean
2654465|NCT01636076|Secondary|Patient Reported Outcome Measures: Medical Outcome Study (MOS) Sleep Scale: Without Quantity Subscale|"Scoring the MOS Sleep Survey is a two-step process:• All items are scored so that a high score reflects more of the attribute implied by the scale name. Each item is converted to a 0 to 100 possible range so that the lowest and highest possible scores are set at 0 and 100, respectively. In this format, scores represent the achieved percentage of the total possible score. For example, a score of 50 represents 50% of the highest possible score.~• Second, items within each scale are averaged together to create the 7 scale scores. Scales with at least one item answered can be used to generate a scale score. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Scores represent the average for all items in the scale that the respondent answered. An additional measure is based on the average number of hours sleep each night during the past 4 weeks and are described in outcome measure 15."|Baseline, 4 and 12 weeks|Full analysis set.|||Units on a scale||Standard Deviation|Mean
2665366|NCT01534208|Primary|Change From Baseline in LH|Mean change from baseline in LH at end of treatment (26 weeks)|6 months|ITT|||mIu/mL||Standard Deviation|Mean
2654466|NCT01636076|Secondary|Patient Reported Outcome Measures: COPD Assessment Test|It consists of eight items, each presented as a semantic 6-point differential scale, providing a total score out of 40. A higher score indicates a worse health status. Scores of 0 - 10, 11 - 20, 21 - 30 and 31 - 40 represent a mild, moderate, severe or very severe clinical impact of COPD upon the patient.|Baseline, 4 and 12 weeks|Full analysis set consisting of all randomized patients|||Units on a scale||Standard Deviation|Mean
2654467|NCT01636076|Secondary|Analysis of the Proportion of Subjects With a Clinically Important Improvement of >=1 Point in the TDI (Transitional Dyspnoea Index)Focal Score by Visit|A TDI focal score of ≥1 is considered to be a clinically important improvement from baseline. Analysis of the proportion of subjects with a clinically important improvement of >=1 point in the TDI focal score, by visit|4 and 12 weeks|Full analysis set, All randomized patients. When data were missing or insufficient for any one of the domains a focal score could not be calculated.|||(%) showing clinical improvement|||Number
2654468|NCT01636076|Secondary|Patient Reported Outcome Measures: SGRQ (St. George's Respiratory Questionnaire)|A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.|4 and 12 weeks|Full analysis set : At baseline all subjects with a baseline value are included. At each post-baseline day, only subjects with a value at both baseline and the respective day are included. Baseline SGRQ was completed on Day 1 prior to first dose.|||Total Score||Standard Deviation|Mean
2654469|NCT01636076|Secondary|The Overall Change in Usage of Rescue Medication (Short Acting β2-agonist) .|This value represents the percent of days in the study where no rescue medication was needed.|Baseline to 12 weeks|Full analysis set consisting of all randomized patients|||% of days||Standard Error|Least Squares Mean
2654470|NCT01636076|Secondary|The Usage of Rescue Medication (Short Acting β2-agonist)|Participants record the number of puffs of rescue medication taken in the previous 12 hours each morning and evening throughout the 12 week treatment period.|12 weeks|Full analysis set consisting of all randomized patients|||Number of puffs||Standard Error|Least Squares Mean
2654471|NCT01636076|Secondary|Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for AUC (5 Min - 23 h 45 Min) for FEV1 (L) on Day 28 and Day 84 (Full Analysis Set, 24-h Profiling Subgroup)|Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), (5 min-24 h) is measured after the first dose on Day 1 and on Day 28 and Day 84 in a subset of approximately 60 patients. Scheduled (not actual) time points are to be used. The interpretation of FEV1 at time 0 is the baseline value at the randomization visit and the latest pre-dose value (-50 min or -15 min) at subsequent visits. The standardized AUC(5 min - 4 h) for FEV1 will be summarized by treatment. The same will be repeated for standardized AUC for FEV1 between 5 min and 24 hours post morning dose.|Day 28, Day 84|Peak FEV1 was calculated for all subjects in the FAS at Day 1 (Visit 201) and was calculated for all subjects in the 24-h profiling subset of the FAS at Day 1 (Visit 201), Day 28 (Visit 203) and Day 84 (Visit 205).|||Liters*hours||Standard Error|Least Squares Mean
2654472|NCT01636076|Secondary|FEV1 AUC (5 Min-4 h),|Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), (5 min-24 h) is measured after the first dose on Day 1 and on Day 28 and Day 84 in a subset of approximately 60 patients. Scheduled (not actual) time points are to be used. The interpretation of FEV1 at time 0 is the baseline value at the randomization visit and the latest pre-dose value (-50 min or -15 min) at subsequent visits. The standardized AUC(5 min - 4 h) for FEV1 will be summarized by treatment. The same will be repeated for standardized AUC for FEV1 between 5 min and 24 hours post morning dose.|Day 1(Baseline), Day 28, Day 84|24 hr profiling subgroup|||Liters*hours||Standard Error|Least Squares Mean
2654473|NCT01636076|Secondary|FEV1 (L) on Day 1 Between-treatment Comparisons of AUC (5min - 4h)|Spirometry is conducted according to the global standard. FEV1 AUC (5 min-4 h), Scheduled (not actual) time points are to be used. The standardized AUC(5 min - 4 h) for FEV1 will be summarized by treatment.|Day 1|Full analysis set consisting of all randomized patients|||Liters * hours||Standard Error|Least Squares Mean
2654474|NCT01636076|Secondary|FEV1/FVC at Each Timepoint|Spirometry is conducted according to the global standard. FEV1/FVC is measured at pre-dose and post dose up to 4 hour on Day 1, Day 28, and Day 84, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minutes on Day 2 and Day 29, and at pre-dose 50 min and 15 min on Day 2, Day 28, and Day 84.|Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85|Full analysis set consisting of all randomized patients|||FEV1/ FVC (%)||Standard Deviation|Mean
2654475|NCT01636076|Secondary|Forced Vital Capacity (FVC) at Each Timepoint|Spirometry is conducted according to the global standard. FVC is measured at pre-dose and post dose up to 4 hour on Day 1, Day 28, and Day 84, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minutes on Day 2 and Day 29, and at pre-dose 50 min and 15 min on Day 2, Day 28, and Day 84.|Day 1, Day 2, Day 28, Day , Day 29, Day 84, Day 85|Full analysis set consisting of all randomized patients|||liters||Standard Deviation|Mean
2654476|NCT01636076|Secondary|Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for FEV1 (L), by Visit and Timepoint||Day 1 through day 85|Full analysis set consisting of all randomized patients|||liter||Standard Error|Least Squares Mean
2654477|NCT01636076|Secondary|Trough FEV1 After First Dose and After 4 Weeks of Treatment|Spirometry is conducted according to the global standard. FEV1 is measured at pre-dose and post dose up to 1 hours on Day 1 and Day 28; 24 hours post-dose on Day 29 and 85. In a subset of approximately 60 patients, FEV1 is measured up to 20 hours postdose on Day 28 and Day 84.|Day 1 and Day 85|All randomized patients were included in the Safety analysis set (SAF) and Full analysis set (FAS).|||Liters||Standard Error|Mean
2654524|NCT01635062|Primary|The Change in Circulating RAS Activity After Calcitriol/Placebo Therapy|The below results represent the change in Plasma Renin Activity.|baseline and 2 weeks following calcitriol/placebo therapy||||ng/mL/h||Inter-Quartile Range|Median
2654478|NCT01636076|Primary|Mixed Model for Repeated Measures (MMRM): Between-treatment Comparisons for Trough FEV1 (L) on Day 85|Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings.|12 weeks|All randomized patients were included in the Full analysis set (FAS)|||Liters||Standard Error|Least Squares Mean
2654479|NCT01636063|Primary|Initial Cervical Dilation at the Time of Surgical Abortion|Initial cervical dilation as measured in French units by a Pratt cervical dilator prior to surgical abortion. The dilation was measured in French units with each French unit being equivalent to 0.33 mm.|24 to 48 hours after enrollment||||French units||Standard Deviation|Mean
2654480|NCT01635933|Secondary|Proportion of Subjects Preferring Study Lens (Strongly or Somewhat)|Participants were asked to compare the study lenses to their habitual lenses using a 5-point scale: strongly prefer study lenses, somewhat prefer study lenses, no preference, somewhat prefer habitual lenses, and strongly prefer habitual lenses, where 'study lenses' refer to either test or control depending on the treatment group. Proportion of subjects preferring study lens is reported as the percentage of participants who strongly or somewhat preferred the study lens.|Day 28|The analysis population includes all enrolled and dispensed participants who had at least 1 study visit after being dispensed the study lenses. No imputation was used for missing values.|||Percentage of participants|||Number
2654481|NCT01635933|Secondary|Subjective Rating of Overall Vision|Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Day 28|The analysis population includes all enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=178,185). No imputation was used for the missing values. Here, “n” is the number of participants with non-missing values at the specific time point for each arm group.|||Units on a scale||Standard Deviation|Mean
2654482|NCT01635933|Primary|Subjective Rating of Overall Comfort|Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Day 28|The analysis population includes all enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=178,185). No imputation was used for the missing values. Here, “n” is the number of participants with non-missing values at the specific time point for each arm group.|||Units on a scale||Standard Deviation|Mean
2654483|NCT01635920|Secondary|Subjective Rating of Overall Comfort|Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Day 28|ITT: All enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=125,126). No imputation was used for the missing values. Here, “n” is the number of participants with non-missing values at the specific time point for each arm group, respectively.|||units on a scale||Standard Deviation|Mean
2654484|NCT01635920|Primary|Percentage of Subjects With Same Fit in Both Eyes|"Lens fit was assessed by the investigator for each eye using a biomicroscope (slit lamp), which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. Same fit was defined as an eye that achieved an acceptable or optimal overall lens fit with the study lens, that was also within one grade of the value observed on the same eye with the habitual lens at the baseline visit."|Up to Day 28|ITT: All enrolled and dispensed participants who had at least one study visit after being dispensed with study lenses (N=125,126). No imputation was used for the missing values. Here, “n” is the number of participants with non-missing values at the specific time point for each arm group, respectively.|||percentage of participants|||Number
2654485|NCT01635881|Secondary|In-hospital Major Adverse Cardiac Events (MACE)|"In-hospital MACE:~All death (cardiac and non-cardiac)~Myocardial infarction (MI)~Target Vessel Revascularization (TVR)~In-hospital Stent Thrombosis (ST) within the target vessel~Clinically significant arrhythmias (requiring intervention)"|Participants will be followed for the duration of hospital stay (an expected average of 24 hours)|Analysis population consists of intent-to-treat subject population.|||percentage of participants||95% Confidence Interval|Number
2654486|NCT01635881|Primary|Device Procedural Success|"Device procedural success consisting of the following:~Successful delivery, inflation, deflation and withdrawal of the study balloon.~No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon.~Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention procedure"|Peri-procedural|Analysis population consists of intent-to-treat subject population.|||percentage of participants||95% Confidence Interval|Number
2654487|NCT01635855|Primary|Rate of Severe Common Adverse Events|"The purpose of this study was to determine if the rate of Severe common adverse events after re-treatment with Belotero Balance differs from the combined rates reported in the Belotero® Balance IDE clinical trial and Belotero® Balance Fitzpatrick Skin Type IV-VI Study (Pre-Approval Studies).Common is defined as pre-specified adverse events occurring in >= 5% of study subjects. These averse events are: bruising, itching, pain, redness, swelling, discoloration, nodule, and induration."|1 month||||percentage of 'severe' common AEs||95% Confidence Interval|Number
2654488|NCT01635764|Primary|Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3|"The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits."|Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204|All participants with baseline skin pain NRS - on average ≥ 3 and with evaluable data at given time point.|||percentage of participants|||Number
2654525|NCT01634854|Secondary|NICU Admission and APGAR Less Than 7 at 5 Minutes|NICU admission and APGAR less than 7 at 5 minutes|Through discharge from hospital||||Participants|||Count of Participants
2654489|NCT01635764|Primary|Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3|"The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits."|Entry of M12-555, and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with baseline skin pain NRS - on average ≥ 3 and with evaluable data at given time point.|||percentage of participants|||Number
2654490|NCT01635764|Primary|Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - On Average at Each Visit Among Participants With Baseline Skin Pain NRS On Average ≥ 3|"The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - on average at each visit among participants with baseline skin pain NRS - on average ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits."|Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with baseline skin pain NRS - on average ≥ 3 and with evaluable data at given time point.|||percentage of participants|||Number
2654491|NCT01635764|Primary|Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3|"The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits."|Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204|All participants with baseline skin pain NRS-at worst ≥3 and with evaluable data at given time point|||percentage of participants|||Number
2654492|NCT01635764|Primary|Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3|"The NRS was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the NRS (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits."|Entry of M12-555, and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with baseline skin pain NRS-at worst ≥3 and with evaluable data at given time point|||percentage of participants|||Number
2654493|NCT01635764|Primary|Percentage of Participants in the EW/EW/EW Analysis Population Achieving Skin Pain NRS30 - At Worst at Each Visit Among Participants With Baseline Skin Pain NRS At Worst ≥ 3|"The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) - at worst at each visit among participants with baseline skin pain NRS - at worst ≥ 3 are presented. Weekly averages of daily assessments were analyzed. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits."|Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with baseline skin pain NRS-at worst ≥3 and with evaluable data at given time point|||percentage of participants|||Number
2654494|NCT01635764|Primary|Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the PBO/EW/EW Analysis Population|The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Baseline (in prior phase 3 study) to Entry of Period B in prior phase 3 study and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204|All participants with evaluable data at given time point.|||units on a scale||Standard Deviation|Mean
2654526|NCT01634854|Secondary|Number of Participants With Excessive Uterine Activity Necessitating Treatment|Number of patients receiving terbutaline during labor for uterine tachysytole|Measured from initiation of medication until delivery time||||Participants|||Count of Participants
2654495|NCT01635764|Primary|Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations|The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Baseline (in prior phase 3 study) to Entry of M12-555 and Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with evaluable data at given time point.|||units on a scale||Standard Deviation|Mean
2654496|NCT01635764|Primary|Modified Sartorius Score: Change From Baseline to Each Visit for Participants in the EW/EW/EW Analysis Population|The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Higher scores indicate greater severity of HS. A negative change indicates decrease in severity. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Baseline (in prior phase 3 study) to Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216|All participants with evaluable data at given time point.|||units on a scale||Standard Deviation|Mean
2654497|NCT01635764|Primary|Percentage of Participants in the PBO/EW/EW Analysis Population Who Achieved AN Count of 0, 1, or 2 at Each Visit|The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204|All participants with evaluable data at given time point.|||percentage of participants|||Number
2654498|NCT01635764|Primary|Percentage of Participants in the EW/EOW/EW, EW/PBO/EW, and PBO/PBO/EW Analysis Populations Who Achieved AN Count of 0, 1, or 2 at Each Visit|The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with evaluable data at given time point.|||percentage of participants|||Number
2654499|NCT01635764|Primary|Percentage of Participants in the EW/EW/EW Analysis Population Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Each Visit|The percentage of participants with AN counts lowered to 0, 1, or 2 at each visit. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216|All participants with evaluable data at given time point.|||percentage of participants|||Number
2654500|NCT01635764|Primary|Percentage of Participants in the PBO/PBO/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit|Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Entry of M12-555, Weeks 4, 8, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192|All participants with evaluable data at given time point.|||percentage of participants|||Number
2654501|NCT01635764|Primary|Percentage of Participants in the PBO/EW/EW Analysis Population Achieving Clinical Response Per HiSCR at Each Visit|Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. LOCF: The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Entry of Period B in prior phase 3 study, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and 204|All participants with evaluable data at given time point.|||percentage of participants|||Number
2654502|NCT01635764|Primary|Percentage of Participants in the EW/EW/EW, EW/EOW/EW, and EW/PBO/EW Analysis Populations Achieving Clinical Response Per Hidradenitis Suppurativa Clinical Response (HiSCR) at Each Visit|Clinical response per HiSCR defined as percent reduction from baseline of the prior phase 3 study in the abscess and inflammatory nodule ≥ 50% (AN50) with no increase in the abscess count and no increase in the draining fistula count. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit was carried forward to impute missing data at later visits.|Weeks 2 (first dose of adalimumab in prior phase 3 study), 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216|All participants with evaluable data at given time point.|||percentage of participants|||Number
2654503|NCT01635504|Primary|Percentage Change in Volume of the Parotid Gland From Baseline to 12 Weeks After Treatment With Botulinum Toxin A||Baseline and 12 weeks||||percentage reduction in parotid volume||Full Range|Mean
2654504|NCT01635504|Primary|Percentage Change in Volume of the Masseter Muscle From Baseline to 12 Weeks After Treatment With Botulinum Toxin A||Baseline and 12 weeks||||percentage reduction in masseter volume||Full Range|Mean
2654505|NCT01635439|Secondary|Normal Vaginal Delivery Rate||24 hours||||participants|||Number
2654506|NCT01635439|Secondary|Need for Syntocinon Augmentation||24 hours||||participants|||Number
2654507|NCT01635439|Secondary|Uterine Hyper-stimulation Rate||24 hours||||participants|||Number
2654508|NCT01635439|Secondary|Induction to Onset of Labor Interval||24 hours||||hours||Standard Deviation|Mean
2654511|NCT01635218|Secondary|Remission Rates at 6 Weeks|17-item Hamilton Rating Scale for Depression is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in 17-item Hamilton Scale for Depression was assessed for this study. It ranges from 0 (no depression) up to 52 (most severe depression). A score < or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), > 24 (severe depression). Remission rate definition: 17-item Hamilton Rating Scale for Depression score < 7 points after 6 weeks of treatment.|6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.|||participants with a score of < 7 in HS|||Number
2654512|NCT01635218|Secondary|Change From Baseline in Greene´s Scale at 6 Weeks.|Greene Climacteric Scale (GS) is intended to be a standard measure of core climacteric symptoms. For this study a total range was assessed at baseline and after six weeks of treatment. A total score 0 (without climacteric symptoms) up to 63 (most severe climacteric symptoms). The change was calculated as the later time point (total score in GS at 6 weeks) minus the earlier time point (total score at baseline).The scale measures four separate sub-scales (anxiety, depression, somatic symptoms and sexual function). The score of the four sub-scales was summed. A total score of 0 -10 is considered without symptoms, 11 - 29 (mild symptoms), 30 - 49 (moderate symptoms) and > 50 (severe symptoms).|Baseline and 6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.The mean and SD presented here in the Outcome measure data table are the final scores after 6 weeks treatment.|||Units in Green Scale||Standard Deviation|Mean
2654513|NCT01635218|Secondary|Responder Rates at 6 Weeks.|17-item Hamilton Rating Scale for Depression is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in 17-item Hamilton Scale for Depression was assessed for this study. It ranges from 0 (no depression) up to 52 (most severe depression). A score < or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), > 24 (severe depression). Responder rate definition: a decrease of 50% or more from baseline score using 17-item Hamilton Rating Scale for Depression after six weeks treatment.|6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets.|||participants with a decrease >50% in HS|||Number
2654514|NCT01635218|Secondary|Change From Baseline in Beck Depression Inventory at 6 Weeks.|Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory that assess severity of depression. A total score range was assessed at baseline and after six weeks of treatment. A score 0 (without depression) up to 63 (most severe depression). For this study the change was calculated as the later time point (total score in BDI at 6 weeks) minus the earlier time point (total score in BDI at baseline). A score 0 - 8 is considered normal, 9 - 18 (mild to moderate depression), 19 - 28 (moderate to severe depression), > 29 (severe depression).|Baseline and 6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population) regardless whether or not they adhered to the treatment protocol or provided complete data sets. The mean and SD presented here in the Outcome measure data table are the final scores after 6 weeks treatment.|||Units in Beck Depression Inventory||Standard Deviation|Mean
2654515|NCT01635218|Primary|Change From Baseline in 17-item Hamilton Rating Scale for Depression at 6 Weeks.|17-item Hamilton Rating Scale for Depression (HRSD) is a well-known standardized scale used worldwide to assess severity of depression. Score ranges from 0 (no depression) up to 52 (maximum depression severity). A total score in HRSD was assessed at baseline and after six weeks of treatment. For this study the change was calculated as the later time point (total score in 17- HRSD at 6 weeks) minus the earlier time point (total score at baseline). A score < or = 7 is considered normal, 7 - 13 (mild depression), 14 - 24 (moderate to severe depression), > 24 (severe depression).|Baseline and 6 weeks|All patients under randomization were included in the primary efficacy population (intention-to-treat population), regardless whether or not they adhered to the treatment protocol or provided complete data sets.The mean and SD presented in outcome measure data table are the final scores in Hamilton Scale after 6 weeks of treatment.|||Units in Hamilton Scale||Standard Deviation|Mean
2654516|NCT01635101|Secondary|Pain Intensity Using the FLACC Score in Older Infants|The FLACC scale is used to assess pain intensity in older infants. The scale is scored in a range of 0-10 with 0 representing no pain. A higher score means more pain.|within 24 hours|Older infants in the mITT population with a score at each data collection time|||score on a scale||Standard Deviation|Mean
2654517|NCT01635101|Secondary|Pain Intensity Using the FLACC Score in Intermediate Aged Infants|The Face, Leg, Activity, Cry, and Consolability (FLACC) scale is used to assess pain intensity in intermediate aged infants. The scale is scored in a range of 0-10 with 0 representing no pain. A higher score means more pain.|within 24 hours|Intermediate aged infants in the mITT population with a score at each data collection time|||score on a scale||Standard Deviation|Mean
2654518|NCT01635101|Secondary|Summary of Pain Intensity Using the LNPS in Younger Infants|The LNPS is used for assessing pain intensity in younger infants. Scores on the scale run from 0-14. Higher scores mean worse pain.|within 24 hours|Younger Infants in the mITT population with scores at each data collection time|||score on a scale||Standard Deviation|Mean
2654519|NCT01635101|Secondary|Summary of Pain Intensity Using the Leuven Neonatal Pain Scale (LNPS) in Neonates|The LNPS is used for assessing pain intensity in neonates. Scores on the scale run from 0-14. Higher scores mean worse pain.|within 24 Hours|Neonates in the mITT population with scores at each data collection time|||score on a scale||Standard Deviation|Mean
2654520|NCT01635101|Secondary|Time to First Rescue Medication||within 24 hours|mITT population|||hours||Inter-Quartile Range|Median
2654521|NCT01635101|Primary|Total Rescue Opioid Consumption|Total micrograms per kilogram (µg/kg) of rescue opioid used during the same 24 hours the subject is on study medication|in 24 hours|mITT population|||µg/kg||Standard Deviation|Mean
2654522|NCT01635062|Secondary|Change in Urine Protein After Calcitriol/Placebo Therapy|Subjects have their urine protein assessed at baseline while sodium loaded and again 3 weeks after randomized therapy with calcitriol or placebo.|baseline and 3 weeks following calcitriol/placebo therapy||||mg/24h||Standard Deviation|Mean
2654527|NCT01634854|Secondary|Maternal Satisfaction With Labor||6 weeks post-partum|data was not collected||||||
2654530|NCT01634854|Secondary|Neonatal APGAR Scores|APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low.|At 1 minute and 5 minutes after delivery||||number||Inter-Quartile Range|Median
2654531|NCT01634854|Primary|Time From Induction to Vaginal Delivery|Comparing the time to delivery in multiparas undergoing induction of labor with vaginal misoprostol or intravenous oxytocin.|Time to delivery in minutes from initiation of medication, up to 24 hours||||minutes||Inter-Quartile Range|Median
2654532|NCT01634659|Secondary|End of Day Comfort|End of day comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. End of day comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.|Day 8|Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.|||Units on a scale||Standard Deviation|Mean
2654533|NCT01634659|Secondary|Overall Quality of Vision|Overall quality of vision was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall quality of vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.|Day 8|Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.|||Units on a scale||Standard Deviation|Mean
2654534|NCT01634659|Primary|Overall Comfort|Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.|Day 8|Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.|||Units on a scale||Standard Deviation|Mean
2654535|NCT01634620|Primary|Mean FeNO Levels by ICD 9 Code Category|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Based on medical history, subjects were given an International Statistical Classification of Diseases and Related Health Problems (ICD) code for concurrent diseases. Of interest, FeNO levels were characterized for subjects coded with chronic obstructive pulmonary disease (COPD) and Asthma, COPD and Emphysema, and then by all other concurrent diseases.|Single Visit|Per-protocol Population|||parts per billion (ppb)||Standard Deviation|Mean
2654536|NCT01634620|Primary|FeNO Levels by ICD 9 Code Category|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Subjects are categorized by low (<25 parts per billion or ppb), moderate (>=25 ppb or <=50 ppb), or high >50 ppb. Based on medical history, subjects were given an Internation Statistical Classification of Diseases and Related Health Problems (ICD) code for concurrent diseases. Of interest, FeNO levels were characterized for subjects coded with chronic obstructive pulmonary disease (COPD) and Asthma, COPD and Emphysema, and then by all other concurrent diseases.|Single Visit|Per-protocol Population|||participants|||Number
2654537|NCT01634620|Primary|FeNO Levels by Smoking Status|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Subjects are categorized by low (<25 parts per billion or ppb), moderate (>=25 ppb or <=50 ppb), or high >50 ppb. Subjects were asked if they are a previous or current smoker via a survey during study visit.|Single Visit||||participants|||Number
2654538|NCT01634620|Primary|FeNO Levels by Inhaled Corticosteroid Use|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. Reported values are the number of participants with low FeNO (<25 parts per billion or ppb), moderate FeNO (>=25 ppb or <=50 ppb), or high FeNO >50 ppb. Use of Inhaled corticosteroids was measured via a survey during study visit.|Single Visit|Per-protocol Population|||participants|||Number
2654539|NCT01634620|Primary|FeNO Levels by GOLD Stage of Severity|Forced exhaled nitric oxide (FeNO) was measured using a NIOX MINO device. The purpose of this study was to characterize FeNO levels indicative of eosinophilic airway inflammation in patients with chronic obstructive pulmonary disease (COPD). The principal investigator classified subjects into one of four stages of severity using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity of COPD stages, with Stage I representing mild COPD severity, Stage II representing moderate COPD severity, Stage III representing severe COPD severity, and Stage IV representing very severe COPD severity (GOLD guidelines, 2012). FeNO levels (in parts per billion or ppb) are summarized for subjects within each category.|Single Visit|Per-protocol Population|||parts per billion (ppb)||Standard Deviation|Mean
2654540|NCT01634620|Primary|Spirometry Results: PEF (L/Min)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population|||Liters per minute||Standard Deviation|Mean
2654541|NCT01634620|Primary|Spirometry Results: FEF25-75 (L/Sec)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population|||Liters per second||Standard Deviation|Mean
2654553|NCT01634360|Secondary|Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study|ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156|Efficacy Population|||Hours||Standard Deviation|Mean
2654542|NCT01634620|Primary|Spirometry Results: FEF50% (L/Sec)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population|||Liters per second||Standard Deviation|Mean
2654543|NCT01634620|Primary|Spirometry Results: FEV1 (% Predicted)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population|||Percent Predicted||Standard Deviation|Mean
2654544|NCT01634620|Primary|Spirometry Results: FVC (L)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population|||Liters||Standard Deviation|Mean
2654545|NCT01634620|Primary|Spirometry Results: FEV1 (L)|Spirometry values were collected according to American Thoracic Society (ATS) guidelines (ATS, 2005). In the event that spirometry preceded forced exhaled nitric oxide (FeNO) measurements, a wait of not less than 20 minutes was imposed to separate the two procedures. Parameters measured were Forced Expiratory Volume in One Second (FEV1), Forced Vital Capacity (FVC), Forced Expiratory Flow 25-75 (FEF15%-75%), Forced Expiratory Flow 50 (FEF50), and Peak Expiratory Flow (PEF). Spirometry measures the severity of a patient's chronic obstructive pulmonary disease (COPD), with lower scores indicating more severe COPD.|Single Visit|Per-protocol Population|||Liters||Standard Deviation|Mean
2654546|NCT01634555|Secondary|Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)|Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group.|Up To 2 Years|All participants with both baseline and at least one post baseline ADA assessments.|||Participants|||Count of Participants
2654547|NCT01634555|Secondary|Pharmacokinetics: Cmax of Ramucirumab (IMC-1121B)||Cycle 2: -2, -1, -0.5, 0, 2, 3, 4, 5, 8, 10, 25, 48, 72, 96, 168, 264, 336 hours post-ramucirumab (IMC-1121B) infusion|All participants who received study drug and had sufficient concentration data to calculate ramucirumab (IMC-1121B) Cmax in Cycle 2.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2654548|NCT01634555|Primary|Pharmacokinetics: Dose-Normalized Cmax of Irinotecan and Its Metabolite SN-38 in Cycle 2|Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geo LS means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 2: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion|All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 Cmax in Cycle 2.|||nanograms/milliliter/milligram||90% Confidence Interval|Least Squares Mean
2654549|NCT01634555|Primary|Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Irinotecan and Its Metabolite SN-38 in Cycle 1|Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geo LS means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 1: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion|All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 Cmax in Cycle 1.|||nanograms/milliliter/milligram||90% Confidence Interval|Least Squares Mean
2654550|NCT01634555|Primary|Pharmacokinetics: Dose-Normalized AUC(0-∞) of Irinotecan and Its Metabolite SN-38 in Cycle 2|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geo LS means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 2: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion|All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 AUC(0-∞) in Cycle 2.|||nanograms*hour/milliliter/milligram||90% Confidence Interval|Least Squares Mean
2654551|NCT01634555|Primary|Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Irinotecan and Its Metabolite SN-38 From Time Zero to Infinity [AUC(0-∞)] in Cycle 1|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 1: 0, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 22, 25, 28, 31, 34, 48, 72, 96 and 168 hours post-irinotecan infusion|All participants in DDI population (who completed the required treatment in Cycle 1, Day 1 and Cycle 2, Day 1) and had sufficient concentration data to calculate irinotecan and its metabolite SN-38 AUC(0-∞) in Cycle 1.|||nanograms*hour/milliliter/milligram||90% Confidence Interval|Least Squares Mean
2654552|NCT01634360|Secondary|Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study|"Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms. Range of possible total scores, 0 to 56.~ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor."|Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156|Efficacy Population|||Scores on scale||Standard Deviation|Mean
2654554|NCT01634360|Primary|Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study|OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary.|Baseline, Week 0, Week 12, Week 24, Week 36, Week 52, Week 78, Week 104, Week 130, Week 156|Efficacy Population- All subjects who were in the Safety Population and for whom at least 1 postbaseline (post Week 0) efficacy assessment was made.|||Hours||Standard Deviation|Mean
2654555|NCT01634269|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 ͭ ͫ Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 24 months||||points||Inter-Quartile Range|Median
2654556|NCT01634269|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 ͭ ͫ Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 12 months||||points||Inter-Quartile Range|Median
2654557|NCT01634269|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 ͭ ͫ Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 6 months||||points||Inter-Quartile Range|Median
2654558|NCT01634269|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2 ͭ ͫ Scoring Program was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. The Z-score of each subdomain is calculated as the numbers of standard deviation away from the Japanese population mean of the corresponding raw score. Norm-based score is then derived as fifty plus 10 times of the z-score. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 30 days||||points||Inter-Quartile Range|Median
2654559|NCT01634269|Secondary|Valve-related Deaths||0 day to 24 months||||prob of freedom from event @ 730 days|||Number
2654560|NCT01634269|Secondary|Valve-related Deaths||0 day to 12 months||||prob of freedom from event @ 365 days|||Number
2654561|NCT01634269|Secondary|Valve-related Deaths||0 day to 6 months||||prob of freedom from event @ 183 days|||Number
2654562|NCT01634269|Secondary|Valve-related Deaths||0 day to 30 days||||prob of freedom from event @ 30 days|||Number
2654563|NCT01634269|Secondary|Repeat Hospitalization||0 day to 24 months||||prob of freedom from event @ 730 days|||Number
2654564|NCT01634269|Secondary|Repeat Hospitalization||0 day to 12 months||||prob of freedom from event @ 365 days|||Number
2654565|NCT01634269|Secondary|Repeat Hospitalization||0 day to 6 months||||prob of freedom from event @ 183 days|||Number
2654566|NCT01634269|Secondary|Repeat Hospitalization||0 day to 30 days||||prob of freedom from event @ 30 days|||Number
2654567|NCT01634269|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR)||24 months||||percentage of participants analyzed|||Number
2654568|NCT01634269|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR)||12 months||||percentage of participants analyzed|||Number
2654569|NCT01634269|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR)||6 months||||percentage of participants analyzed|||Number
2654570|NCT01634269|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Regurgitation (Transvalvular & Paravalvular) (Total AR)||30 days||||percentage of participants analyzed|||Number
2654571|NCT01634269|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||24 months||||percent||Standard Deviation|Mean
2654572|NCT01634269|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||12 months||||percent||Standard Deviation|Mean
2654573|NCT01634269|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||6 months||||percent||Standard Deviation|Mean
2654574|NCT01634269|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||30 days||||percent||Standard Deviation|Mean
2654575|NCT01634269|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA)||24 months||||cm²||Standard Deviation|Mean
2654576|NCT01634269|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Effective Orifice Area (EOA)||12 months||||cm²||Standard Deviation|Mean
2654583|NCT01634269|Secondary|Procedural Success, Defined as Device Success and Absence of In-hospital MACCE|Procedural success is defined as device success and absence of in-hospital MACCE.|from admission for procedure to discharge|This includes subjects with an index procedure. Index procedure is defined as the first procedure that Medtronic MDT-2111 TAV system delivery catheter is introduced.|||percent|||Number
2654584|NCT01634269|Secondary|Device Success as Defined in the Description.|"The following components must be satisfied for device success:~successful vascular access, delivery and deployment of device and successful retrieval of delivery system~correct position of device in the proper anatomical location~EOA≥1.0 cm² AND mean gradient <20 mmHg or peak velocity <3 m/s, without moderate or severe AR~only one valve implanted."|after procedure or discharge|This includes subjects with an index procedure. Index procedure is defined as the first procedure that Medtronic MDT-2111 TAV system delivery catheter is introduced.|||percentage of participants analyzed|||Number
2654585|NCT01634269|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~all-cause death~myocardial infarction (MI)~all stroke, and~reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 24 months|The Kaplan-Meier Method was used to calculate the number.|||prob of freedom from event @ 730 days|||Number
2654586|NCT01634269|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~all-cause death~myocardial infarction (MI)~all stroke, and~reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 12 months|The Kaplan-Meier Method was used to calculate the number.|||prob of freedom from event @ 365 days|||Number
2654587|NCT01634269|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~all-cause death~myocardial infarction (MI)~all stroke, and~reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 6 months|The Kaplan-Meier Method was used to calculate the number.|||prob of freedom from event @ 183 days|||Number
2654588|NCT01634269|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~all-cause death~myocardial infarction (MI)~all stroke, and~reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 30 days|The Kaplan-Meier Method was used to calculate the number.|||prob of freedom from event @ 30 days|||Number
2654589|NCT01634269|Secondary|New York Heart Classification (NYHA) Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity.~Class II: Subjects with cardiac disease resulting in slight limitation of physical activity.~Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.~Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort."|24 months|All Implanted Subjects|||percentage of participants analyzed|||Number
2654590|NCT01634269|Secondary|New York Heart Classification (NYHA) Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity.~Class II: Subjects with cardiac disease resulting in slight limitation of physical activity.~Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.~Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort."|12 months|All Implanted Subjects|||percentage of participants analyzed|||Number
2654591|NCT01634269|Secondary|New York Heart Classification (NYHA) Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity.~Class II: Subjects with cardiac disease resulting in slight limitation of physical activity.~Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.~Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort."|6 months|All Implanted Subjects|||percentage of participants analyzed|||Number
2654592|NCT01634269|Secondary|New York Heart Classification (NYHA) Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Subject with cardiac disease but without resulting limitations of physical activity.~Class II: Subjects with cardiac disease resulting in slight limitation of physical activity.~Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.~Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort."|30 days|All Implanted Subjects|||percentage of participants analyzed|||Number
2654593|NCT01634269|Primary|Composite Score of Change in New York Heart Association (NYHA) Class and Effective Orifice Area (EOA).|The primary endpoint is a composite of functional effectiveness as measured by improvement of at least 1 NYHA class from baseline to 6 months and anatomical effectiveness as measured by Effective Orifice Area (EOA) ≥1.0 cm² at 6 months.|baseline and 6 months|Implanted subjects|||percentage of participants analyzed|||Number
2654594|NCT01634256|Secondary|Changes in Serum Bilirubin|serum bilirubin was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||mg/dL||Standard Deviation|Mean
2654595|NCT01634256|Secondary|Changes in γ-GT(Gamma-Glutamyl Transferase)|γ-GT was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||IU/L||Standard Deviation|Mean
2654596|NCT01634256|Secondary|Changes in ALP(Alkaline Phosphatase)|ALP was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||IU/L||Standard Deviation|Mean
2654597|NCT01634256|Secondary|Changes in AST(Aspartate Transaminase)|AST was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||IU/L||Standard Deviation|Mean
2654598|NCT01634256|Primary|Changes in ALT(Alanine Transaminase)|ALT was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||IU/L||Standard Deviation|Mean
2654599|NCT01634243|Secondary|Off Time for Advanced Parkinson's Disease With Concomitant L-dopa Therapy|Mean change (LOCF) from baseline in off time at 12 weeks after dosing.|Baseline, 12 weeks after dosing|Subjects with measurable off time data at baseline and after dosing, LOCF|||Hours||Standard Deviation|Mean
2654600|NCT01634243|Secondary|Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and Part 3 Sum Score for Advanced Parkinson's Disease With Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score (average score of on state and off state) and Part 3 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF|||Scores on a scale||Standard Deviation|Mean
2654601|NCT01634243|Secondary|UPDRS Part 2 Sum Score (Average Score of on State and Off State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average score of on state and off state) at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF|||Scores on a scale||Standard Deviation|Mean
2654602|NCT01634243|Secondary|UPDRS Part 2 Sum Score (Off State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy.|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state) at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF|||Scores on a scale||Standard Deviation|Mean
2654603|NCT01634243|Secondary|UPDRS Part 2 Sum Score (on State) for Advanced Parkinson's Disease With Concomitant L-dopa Therapy.|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state) at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF|||Scores on a scale||Standard Deviation|Mean
2654604|NCT01634243|Secondary|UPDRS Part 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF|||Scores on a scale||Standard Deviation|Mean
2654605|NCT01634243|Secondary|UPDRS Part 2 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|Efficacy analysis set, LOCF|||Scores on a scale||Standard Deviation|Mean
2654606|NCT01634243|Secondary|UPDRS Part 3 Sum Score for Advanced Parkinson's Disease With Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 12 weeks after dosing|Efficacy analysis set, LOCF|||Scores on a scale||Standard Deviation|Mean
2654607|NCT01634243|Secondary|Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score for Early Parkinson's Disease Without Concomitant L-dopa Therapy|"Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score and Part 3 sum at 12 weeks after dosing.~UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 12 weeks after dosing|Efficacy analysis set, last observation carried forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
2654608|NCT01634243|Secondary|Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters|Incidence and severity of adverse events, vital signs, and laboratory parameters following the initiation of study treatment.|Up to 12 weeks after dosing|Safety analysis set|||participants|||Number
2654609|NCT01634243|Primary|Maintenance Dose of the SPM962|The maintenance dose of the SPM 962 was examined based on the safety and efficacy.|Up to 12 weeks after dosing|Subjects in the safety analysis set who entered the maintenance period|||participants|||Number
2654610|NCT01634165|Secondary|Total Amount of Glucose Infused (Gtot)|Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.|Postdose up to 24 hours after administration of study drug|All participants who received study drug and had Gtot measurements. Participants were analyzed based on the treatment they received.|||milligrams per kilograms (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
2654611|NCT01634165|Secondary|Maximum Glucose Infusion Rate (Rmax)|Rmax is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.|Postdose up to 24 hours after administration of study drug|All participants who received study drug and had Rmax measurements. Participants were analyzed based on the treatment they received.|||milligrams/kilograms/minute (mg/kg/min)||Geometric Coefficient of Variation|Geometric Mean
2654612|NCT01634165|Secondary|Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) From Time Zero to Last Measured Concentration Value [AUC(0-tlast)] of LY2963016 or Lantus|Results for LY2936016 treatment arms provide the AUC(0-tlast) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-tlast) for Lantus.|Predose up to 24 hours after administration of study drug|All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-tlast). Participants were analyzed based on the treatment they received.|||picomoles*hour per liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2654613|NCT01634165|Secondary|Pharmacokinetics: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 or Lantus|Results for LY2936016 treatment arms provide the AUC(0-24) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-24) for Lantus.|Predose up to 24 hours after administration of study drug|All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.|||picomoles*hour per liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2654614|NCT01634165|Primary|Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax)||Predose up to 24 hours after administration of study drug|All participants who received study drug and had sufficient pharmacokinetic data to calculate Cmax. Participants were analyzed based on the treatment they received.|||picomoles per liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
2654615|NCT01634165|Primary|Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)]|Results for LY2936016 treatment arms provide the AUC(0-∞) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-∞) for Lantus.|Predose up to 24 hours after administration of study drug|All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-∞). Participants were analyzed based on the treatment they received.|||picomoles*hour per liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2654616|NCT01634152|Secondary|Change From Baseline in Asthma Symptom-free Days|"Change from baseline in asthma symptom-free days based on the weekly mean at week 12.~A day was considered as an asthma symptom-free day if there were no symptoms reported via the e-Diary and no use of rescue medication reported via the eDiary during that day.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Days||Standard Error|Mean
2654617|NCT01634152|Secondary|Change From Baseline in Daytime Experiences of Wheeze or Cough|"Change from baseline in daytime experiences of wheeze or cough based on the weekly mean at week 12.~Daytime experiences of wheeze or cough was assessed by the question did you experience wheeze or cough during the day? from the e-diary. Scores range from 1 (not at all) to 5 (all the time).~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
2654618|NCT01634152|Secondary|Change From Baseline in Daytime Experiences of Shortness of Breath|"Change from baseline in daytime experiences of shortness of breath based on the weekly mean at week 12.~Daytime experiences of shortness of breath was assessed by the question how much shortness of breath did you experience during the day from the e-diary. Scores range from 1 (none) to 5 (a very great deal).~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
2654619|NCT01634152|Secondary|Change From Baseline in Daytime Activity Limitations|"Change from baseline in daytime activity limitations based on the weekly mean at week 12.~Daytime activity limitations was assessed by the question how limited were you in your activities today because of your asthma? from the e-diary. Scores range from 1 (not limited) to 5 (totally limited).~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
2654620|NCT01634152|Secondary|Change From Baseline in Daytime Asthma Symptoms|"Change from baseline in daytime asthma symptoms based on the weekly mean at week 12.~Daytime asthma symptoms was assessed by the question how were your asthma symptoms during the day? from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
2654621|NCT01634152|Secondary|Change From Baseline in Morning Asthma Symptoms|"Change from baseline in morning asthma symptoms based on the weekly mean at week 12.~Morning asthma symptoms was assessed by the question how were your asthma symptoms this morning? from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
2654622|NCT01634152|Secondary|Change From Baseline in Nighttime Awakenings|"Change from baseline in nighttime awakenings based on the weekly mean at week 12.~Nighttime awakenings was assessed by the question Did you wake up during the night due to your asthma? from the e-diary. Scores range from 1 (did not wake up) to 5 (was awake all night).~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
2654623|NCT01634152|Secondary|FEV1 p.m. Change From Baseline|"Change from baseline in evening (p.m.) FEV1 based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
2654624|NCT01634152|Secondary|FEV1 a.m. Change From Baseline|"Change from baseline in morning (a.m.) FEV1 based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
2654625|NCT01634152|Secondary|Peak Expiratory Flow (PEF) Variability Change From Baseline|"Change from baseline in the peak expiratory flow variability based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Percentage of PEF||Standard Error|Mean
2654626|NCT01634152|Secondary|Peak Expiratory Flow (PEF) p.m. Change From Baseline|"Change from baseline in the evening (p.m.) peak expiratory flow based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||L/min||Standard Error|Mean
2654627|NCT01634152|Secondary|Peak Expiratory Flow (PEF) a.m. Change From Baseline|"Change from baseline in the morning (a.m.) peak expiratory flow based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||L/min||Standard Error|Mean
2654628|NCT01634152|Secondary|Use of PRN Rescue Medication During the Night-time|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the night-time based on the weekly mean at week 12.~Measured values presented are actually adjusted means"|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Number of puffs of rescue medication||Standard Error|Mean
2654629|NCT01634152|Secondary|Use of PRN Rescue Medication During the Daytime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the daytime based on the weekly mean at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Number of puffs of rescue medication||Standard Error|Mean
2654630|NCT01634152|Secondary|Use of PRN Rescue Medication Per Day|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used per day (24 hour period) based on the weekly mean at week 12.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Number of puffs of rescue medication||Standard Error|Mean
2654631|NCT01634152|Secondary|ACQ-IA Total Score Responders|"Responder categories based on the ACQ-IA total score after 12 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5) No statistical testing was performed for ACQ-IA total score responders.~The ACQ-IA is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|12 weeks|FAS, missing data for patients not withdrawn from the study were either categorised as no change or based on available data, withdrawn patients were imputed based upon discontinuation reason.|||Percentage of participants|||Number
2654632|NCT01634152|Secondary|Control of Asthma as Assessed by ACQ-IA Total Score|"Change from baseline in Interviewer-Administered Asthma Control Questionnaire (ACQ-IA) total score measured at week 12.~The ACQ-IA is a scale containing 7 questions. Each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ-IA total score is calculated as the mean of the responses to all 7 questions.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
2654633|NCT01634152|Secondary|FVC Change From Baseline at Each Individual Timepoint|"FVC change from baseline at each individual timepoint.~The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
2654634|NCT01634152|Secondary|FEV1 Change From Baseline at Each Individual Timepoint|"Forced expiratory volume in one second (FEV1) change from baseline at each individual timepoint.~The measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
2654635|NCT01634152|Secondary|FVC AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FVC (Forced vital capacity) (FVC AUC (0-3h)) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~Measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
2654636|NCT01634152|Secondary|FEV1 AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FEV1 (FEV1 AUC (0-3h)) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~Measured values presented are actually adjusted means."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
2654637|NCT01634152|Secondary|Trough FVC Change From Baseline|"Change from baseline in Trough (pre-dose) FVC measured at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
2654638|NCT01634152|Secondary|FVC Peak(0-3h) Change From Baseline|"Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak(0-3h)) after 12 weeks of treatment.~The measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
2654639|NCT01634152|Secondary|Trough FEV1 Change From Baseline|"Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
2654640|NCT01634152|Primary|FEV1 Peak(0-3h) Change From Baseline|"Change from baseline in peak forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak(0-3h)) measured at week 12.~Measured values presented are actually adjusted means."|Baseline and 12 weeks|Full Analysis Set (FAS) was the same as the treated set which included all randomised patients who were dispensed and received at least one documented dose of trial medication. Missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
2654641|NCT01634139|Secondary|Change From Baseline in Asthma Symptom-free Days|"Change from baseline in asthma symptom-free days based on the weekly mean at weeks 24 and 48.~A day was considered as an asthma symptom-free day if there were no symptoms reported via the e-Diary (electronic diary) and no use of rescue medication reported via the eDiary during that day.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Days||Standard Error|Mean
2654642|NCT01634139|Secondary|Change From Baseline in Daytime Experiences of Wheeze or Cough|"Change from baseline in daytime experiences of wheeze or cough based on the weekly mean at weeks 24 and 48.~Daytime experiences of wheeze or cough was assessed by the question did you experience wheeze or cough during the day? from the e-diary. Scores range from 1 (not at all) to 5 (all the time).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
2654643|NCT01634139|Secondary|Change From Baseline in Daytime Experiences of Shortness of Breath|"Change from baseline in daytime experiences of shortness of breath based on the weekly mean at weeks 24 and 48.~Daytime experiences of shortness of breath was assessed by the question how much shortness of breath did you experience during the day from the e-diary. Scores range from 1 (none) to 5 (a very great deal).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
2654644|NCT01634139|Secondary|Change From Baseline in Daytime Activity Limitations|"Change from baseline in daytime activity limitations based on the weekly mean at weeks 24 and 48.~Daytime activity limitations was assessed by the question how limited were you in your activities today because of your asthma? from the e-diary. Scores range from 1 (not limited) to 5 (totally limited).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
2654645|NCT01634139|Secondary|Change From Baseline in Daytime Asthma Symptoms|"Change from baseline in daytime asthma symptoms based on the weekly mean at weeks 24 and 48.~Daytime asthma symptoms was assessed by the question how were your asthma symptoms during the day? from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
2654646|NCT01634139|Secondary|Change From Baseline in Morning Asthma Symptoms|"Change from baseline in morning asthma symptoms based on the weekly mean at weeks 24 and 48.~Morning asthma symptoms was assessed by the question how were your asthma symptoms this morning? from the e-diary. Scores range from 1 (no asthma symptoms) to 5 (very severe asthma symptoms).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
2654647|NCT01634139|Secondary|Change From Baseline in Nighttime Awakenings|"Change from baseline in nighttime awakenings based on the weekly mean at weeks 24 and 48.~Nighttime awakenings was assessed by the question Did you wake up during the night due to your asthma? from the e-diary. Scores range from 1 (did not wake up) to 5 (was awake all night).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a scale||Standard Error|Mean
2654767|NCT01632709|Secondary|Change in Perceived Disability (PDI)|The PDI is a seven-item validated instrument that assesses perceived disability in 7 key life areas. The Pain Disability Scale is a scale from 0-70 where 0= no disability and 70=the most disability|PDI collected pre injection and 1 week post injection|all available data was analyzed (some subjects did not complete all outcomes)|||units on a scale||Standard Deviation|Mean
2654648|NCT01634139|Secondary|Responders in PAQLQ(S) at Weeks 24 and 48|"Responders in PAQLQ(S) at weeks 24 and 48. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≥0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≤-0.5). No statistical testing was performed for PAQLQ(S) total score responders.~The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control)."|Weeks 24 and 48.|FAS, missing data for patients not withdrawn from the study were either categorised as no change or based on available data, withdrawn patients were imputed based upon discontinuation reason.|||Patients|||Number
2654649|NCT01634139|Secondary|PAQLQ(S) Emotional Function Domain Score|"PAQLQ(S) emotional function domain score at weeks 24 and 48. The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). The individual domain score is calculated as the mean of the items in this domain.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a Scale||Standard Error|Mean
2654650|NCT01634139|Secondary|PAQLQ(S) Activity Limitation Domain Score|"PAQLQ(S) activity limitation domain score at weeks 24 and 48. The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). The individual domain score is calculated as the mean of the items in this domain.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a Scale||Standard Error|Mean
2654651|NCT01634139|Secondary|PAQLQ(S) Symptom Domain Score|"PAQLQ(S) symptom domain score at weeks 24 and 48. The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). The individual domain score was calculated as the mean of the items in the domain.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a Scale||Standard Error|Mean
2654652|NCT01634139|Secondary|PAQLQ(S) Total Score|"Standardised Paediatric Asthma Quality of Life Questionnaire (PAQLQ(S)) total score at weeks 24 and 48.~The PAQLQ(S) is 23 questions on a 7-point scale, ranging from 1 (worst control) to 7 (best control). Total Score is calculated as mean of all 23 questions.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a Scale||Standard Error|Mean
2654653|NCT01634139|Secondary|ACQ−IA Responder Analysis|"Responder categories based on the ACQ-IA total score after 24 and 48 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5). No statistical testing was performed for ACQ-IA total score responders.~The ACQ-IA is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment."|Weeks 24 and 48|FAS, missing data for patients not withdrawn from the study were either categorised as no change or based on available data, withdrawn patients were imputed based upon discontinuation reason|||Patients|||Number
2654654|NCT01634139|Secondary|ACQ−IA Total Score|"Interviewer Administered Asthma Control Questionnaire (ACQ-IA) total score after 24 and 48 weeks of treatment.~The ACQ-IA is a scale containing 7 questions. Each question has a 7 point scale which ranges from 0 to 6. A score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ-IA total score is calculated as the mean of the responses to all 7 questions.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Weeks 24 and 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Units on a Scale||Standard Error|Mean
2654655|NCT01634139|Secondary|FEV1 p.m. Change From Baseline|"Change from baseline in evening (p.m.) FEV1 based on the weekly mean at week 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
2654656|NCT01634139|Secondary|FEV1 a.m Change From Baseline|"Change from baseline in morning (a.m.) FEV1 based on the weekly mean at week 24 and 48.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres||Standard Error|Mean
2654657|NCT01634139|Secondary|PEF Variability Change From Baseline|"Change from baseline in the peak expiratory flow variability based on the weekly mean at week 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Percentage of PEF||Standard Error|Mean
2654658|NCT01634139|Secondary|PEF p.m. Change From Baseline|"Change from baseline in the evening (p.m.) peak expiratory flow based on the weekly mean at weeks 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres per min (L/min)||Standard Error|Mean
2654659|NCT01634139|Secondary|Peak Expiratory Flow (PEF) a.m. Change From Baseline|"Change from baseline in the morning (a.m.) peak expiratory flow based on the weekly mean at weeks 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres per min (L/min)||Standard Error|Mean
2654660|NCT01634139|Secondary|Use of PRN Rescue Medication During Nighttime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during nighttime based on the weekly mean at weeks 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Number of puffs of rescue medication||Standard Error|Mean
2654661|NCT01634139|Secondary|Use of PRN Rescue Medication During Daytime|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during daytime based on the weekly mean at weeks 24 and 48.~Measured values presented are actually adjusted means~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Number of puffs of rescue medication||Standard Error|Mean
2654662|NCT01634139|Secondary|Use of PRN (Pro re Nata) Rescue Medication Per Day|"Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used per day (24 hour period) based on the weekly mean at weeks 24 and 48.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Number of puffs of rescue medication||Standard Error|Mean
2654663|NCT01634139|Secondary|FVC Change From Baseline at Each Individual Timepoint|"FVC change from baseline to week 24 at each individual timepoint.~The measured values presented are actually adjusted means~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at Week 24|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
2654664|NCT01634139|Secondary|FVC AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FVC (Forced vital capacity) (FVC AUC (0-3h)) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
2654665|NCT01634139|Secondary|Trough FVC Change From Baseline|"Change from baseline in Trough (pre-dose) FVC measured at week 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
2654666|NCT01634139|Secondary|FVC Peak(0-3h) Change From Baseline|"Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak(0-3h)) after 24 and 48 Weeks of treatment.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
2654667|NCT01634139|Secondary|FEV1 Change From Baseline at Each Individual Timepoint|"FEV1 change from baseline to week 24 at each individual timepoint.~The measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
2655723|NCT01623323|Primary|Adverse Events|Adverse Events were collected via spontaneous subject report and through physician examination. The display of adverse events is by subject.|Baseline to 3 months or End of Study|All subject who received at least one dose of study medication|||participants|||Number
2654668|NCT01634139|Secondary|FEV1 AUC (0-3h) Change From Baseline|"Change from baseline of area under the curve (AUC) from 0 to 3 hours for FEV1 (FEV1 AUC (0-3h)) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at week 24|FAS, missing data at a visit was imputed by the available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
2654669|NCT01634139|Secondary|FEV1 Peak (0-3h) at Week 48 Change From Baseline|"Change from baseline in peak forced expiratory volume (FEV) in 1 second within the first 3 hours (h) post dosing (FEV1 peak(0-3h)) measured at week 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|Baseline and Week 48.|FAS. Missing data at a visit was imputed by available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
2654670|NCT01634139|Secondary|Trough FEV1 Change From Baseline|"Change from Baseline in Trough (pre-dose) Forced Expiratory Volume (FEV) in 1 second (FEV1) measured at week 24 and 48.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants included in the statistical model whereas the N's for each timepoint display the number of participants with available data at that timepoint."|Baseline and Week 24, Baseline and Week 48.|Full Analysis Set (FAS) was equal to treated set which included all randomised patients who received at least 1 documented dose of study medication. Missing data at a visit was imputed by available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
2654671|NCT01634139|Primary|FEV1 Peak (0-3h) Change From Baseline|"Change from baseline in peak forced expiratory volume (FEV) in 1 second within the first 3 hours (h) post dosing (FEV1 peak(0-3h)) measured at week 24.~Measured values presented are actually adjusted means.~The number of participants analysed displays the number of participants with available data at the timepoint of interest."|Baseline and 24 Weeks.|Full Analysis Set (FAS) was equal to treated set which included all randomised patients who received at least 1 documented dose of study medication. Missing data at a visit was imputed by available data from the patient at that visit. Completely missing data were handled by the statistical model.|||Litres (L)||Standard Error|Mean
2654672|NCT01634113|Secondary|Individual FVC Measurements|Change from baseline in individual FVC measurements at each timepoint after 12 weeks|Baseline and 12 weeks|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.|||Litres||Standard Deviation|Mean
2654673|NCT01634113|Secondary|Individual FEV1 Measurements|Change from baseline in individual FEV1 measurements at each timepoint after 12 weeks|Baseline and 12 weeks|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.|||Litres||Standard Deviation|Mean
2654674|NCT01634113|Secondary|FVC AUC (0-3h) Change From Baseline|Change from baseline of area under the curve (AUC) from 0 to 3 h for FVC (FVC AUC0-3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).|10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.|||Litres||Standard Deviation|Mean
2654675|NCT01634113|Secondary|Trough FVC Change From Baseline|Change from baseline of trough (pre-dose) forced vital capacity (FVC) measured 10 min before the administration of trial medication after 12 weeks of treatment.|Baseline and 12 weeks|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.|||Litres||Standard Deviation|Mean
2654676|NCT01634113|Secondary|FVC Peak (0-3h) Change From Baseline|Change from baseline in maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak (0-3h)) after 12 weeks of treatment.|10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.|||Litres||Standard Deviation|Mean
2654677|NCT01634113|Secondary|FEV1 AUC (0-3h) Change From Baseline|Change from baseline of area under the curve (AUC) from 0 to 3 h for FEV1 (FEV1 AUC 0-3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).|10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.|||Litres||Standard Deviation|Mean
2654678|NCT01634113|Secondary|Trough FEV1 Change From Baseline|Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12.|Baseline and 12 weeks|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.|||Litres||Standard Deviation|Mean
2654679|NCT01634113|Secondary|Weekly Mean Nighttime Awakenings Due to Asthma Symptoms|"Change from baseline in the weekly mean nighttime awakenings due to asthma symptoms as assessed by the PACD, in the last week of the 12 week treatment period.~The weekly mean was calculated as the average of the weekly scores for the question Did your child wake up during the night due to his/her asthma? The question was answered on a 5-point verbal rating scale, with scores ranging from 1 (did not wake up) to 5 (was awake all night). A week was defined as 7 days.~The measured values presented are adjusted means"|Baseline and 12 weeks|Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.|||units on a scale||Standard Error|Mean
2654768|NCT01632709|Primary|Change in Pain|Pain rating before and after injection on a 0-10 NRS pain scale (0=no pain, 10= worst pain imaginable)|Pain rating before and at 15 minutes and 1 hour post injection|all available data was analyzed (some subjects did not complete all outcomes)|||units on a scale||Standard Deviation|Mean
2654680|NCT01634113|Secondary|Weekly Percentage of Days With Use of Salbutamol (Albuterol) Rescue Medication|Weekly percentage of days with use of salbutamol (albuterol) rescue medication at week 12. A week was defined as 7 days.|12 weeks|Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.|||percentage of days||Standard Deviation|Mean
2654681|NCT01634113|Secondary|Weekly Percentage of Days Without Asthma Symptoms|"Weekly Percentage of days without asthma symptoms at week 12.~A day without asthma symptoms was defined as a day during which the patient experienced no asthma symptoms, did not use rescue medication (salbutamol/albuterol) and had no asthma exacerbation/worsening requiring systemic corticosteroids, or unscheduled visits to a doctor's office, emergency department, or hospital. A week was defined as 7 days.~The measured values presented are adjusted means"|12 weeks|Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.|||percentage of days||Standard Error|Mean
2654682|NCT01634113|Secondary|Weekly Mean Overnight Asthma Symptom Score Response|"Change from baseline in the weekly mean overnight asthma symptom score response as assessed by the PACD in the last week of the 12 week treatment period.~The overnight score is the score from the following question in the PACD, How much did your child cough last night after your child was put to bed for the night until he/she awoke this morning?. This endpoint was determined only for patients with 2 or more nights with symptoms per week during the baseline period. In this case, the baseline period is the 7 days used to derive the baseline value. A patient has a night with symptoms if the question was answered with scores 1, 2, 3, 4 or 5 or the patient received β-Agonist at least one time since he/she went to bed. A week was defined as 7 days.~Scores range from 0 (best) to 4 (worst), a value of 5 indicates severity of symptoms is unknown.~The measured values presented are adjusted means"|Baseline and 12 weeks|Full analysis set, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.|||units on a scale||Standard Error|Mean
2654683|NCT01634113|Primary|FEV1 Peak (0-3h) Change From Baseline|Change from baseline in peak Forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak (0-3h)) measured at week 12|10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12|Full analysis set including only 5 years olds capable of providing technically acceptable pulmonary function tests (PFTs). No imputation for missing data was employed.|||Litres||Standard Deviation|Mean
2654684|NCT01634113|Primary|Weekly Mean Combined Daytime Asthma Symptom Score|"Change from baseline in the weekly mean combined daytime asthma symptom score as assessed by the Paediatric Asthma Caregivers Diary (PACD) in the last week of the 12 week treatment period.~The PACD is a diary designed to evaluate daily asthma symptoms in children aged 2-5 years. The diary consists of three questions to be answered each morning, when the child wakes up, and seven questions to be answered each evening, right after the child goes to bed for the night. A week was defined as 7 days.~The combined daytime score is the average of scores from questions 4 - 7 in the diary which are questions regarding severity of cough, wheezing, trouble breathing and interference with activities, scores for each question range from 0 (best) to 5 (worst). The week 12 weekly mean is the mean of the responses for each day averaged over the 7 days in week 12, so combined daytime asthma symptom scores also range from 0 (best) to 5 (worst).~The measured values presented are adjusted means."|Baseline and 12 weeks|Full analysis set, which included all randomised patients who received at least one dose of trial medication, including patients with available endpoint data at week 12. Missing data in a week was imputed by the available data from the patient during that week, for weeks where data was completely missing no imputation was employed.|||units on a scale||Standard Error|Mean
2654685|NCT01634100|Secondary|Total Empagliflozin: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of total empagliflozin (empa) in plasma over the time interval from 0 extrapolated to the time of last the quantifiable data point.|15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose|Pharmacokinetic (PK) set: The PK analysis set includes all subjects who took at least 1 dose of investigational treatment and provided at least 1 evaluable observation for at least 1 primary PK endpoint in at least 1 treatment period without any important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2654686|NCT01634100|Primary|Total Empa: Maximum Measured Concentration (Cmax)|Maximum measured concentration of total empa in plasma, per period.|15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose|Pharmacokinetic (PK) set: The PK analysis set includes all subjects who took at least 1 dose of investigational treatment and provided at least 1 evaluable observation for at least 1 primary PK endpoint in at least 1 treatment period without any important protocol violations relevant to the evaluation of PK.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2654687|NCT01634100|Primary|Total Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of total empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.|15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose|Pharmacokinetic (PK) set: The PK analysis set includes all subjects who took at least 1 dose of investigational treatment and provided at least 1 evaluable observation for at least 1 primary PK endpoint in at least 1 treatment period without any important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2654706|NCT01633827|Secondary|Apnea-Hypopnea Index|The Apnea-Hypopnea Index (AHI) is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow).|Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2)|During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject results for the 20 remaining patients are reported here per intervention.|||events/hr||Standard Error|Mean
2655724|NCT01623310|Secondary|Nasal Polyp Surgery Eligibility||Baseline, Month 3, Month 12|The Safety Analysis Set included all subjects who received at least 1 dose of study drug.|||Participants|||Count of Participants
2654688|NCT01633944|Secondary|Change From Baseline to Week 12 in Medical Outcomes Score Sleep Subscale|Medical Outcomes Score (MOS) Sleep Scale uses 12 items to measure 6 dimensions of sleep (sleep disturbance, somnolence, sleep adequacy, snoring, awaken short of breath or headache, and quantity of sleep/optimal sleep) and an overall sleep problems index score. The scores of the dimensions (except quantity of sleep/optimal sleep) and of the sleep problem index range on a 0 to 100 scale, with higher scores reflecting more of the attribute implied by the name (eg, greater sleep disturbance, greater adequacy of sleep).|Baseline, Week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (41). Includes only participants with MOS assessment at week 12 (n=199 buprenorphine and n=194 placebo).|||units on a scale||Standard Deviation|Mean
2654689|NCT01633944|Secondary|Change From Baseline to Week 12 in Roland Morris Disability Questionnaire|Subjects assess disability due to back pain using the Roland Morris Disability Questionnaire (RMDQ) consisting of 24 statements of disability. The score of the RMDQ is the total number of items checked, ranging from 0 to 24 with higher scores indicating greater disability.|Baseline, Week 12|Analysis based on PRO population; randomized subjects who received at least 1 dose of double-blind study medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site are excluded from the population (41). Includes only participants with RMDQ assessment at week 12 (n=193 buprenorphine and n=189 placebo).|||units on a scale||Standard Deviation|Mean
2654690|NCT01633944|Secondary|Patient Global Impression of Change|Subjects assessed their change in activity limitations as they relate to their painful condition since beginning treatment using the Patient Global Impression of Change (PGIC) questionnaire, a 7-point scale ranging from 1 (no change [or condition has got worse]) to 7 (a great deal better, and a considerable improvement that made all the difference)|Week 12|Analysis based on Patient-Reported Outcomes (PRO) population; randomized subjects who received at least 1 dose of double-blind medication and had at least 1 post-dose assessment on PRO measures. Subjects from 1 site excluded from population (41). Includes only participants with PGIC assessment at week 12 (n=198 buprenorphine and n=194 placebo).|||units on a scale||Standard Deviation|Mean
2654691|NCT01633944|Secondary|Percentage of Participants With Treatment Failure in the Double-blind Treatment Phase (up to 12 Weeks)|Treatment failure is defined as study discontinuation due to lack of efficacy or discontinuation due to adverse events in the double-blind treatment phase.|Baseline to treatment failure or end of double-blind treatment phase (up to 12 weeks)|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population.|||percentage of participants|||Number
2654692|NCT01633944|Secondary|Time to Optimal Dose of Open-label Study Medication|"Overall time to reach the optimal dose of study medication required to progress to double-blind treatment."|Up to 8 weeks in open-label titration|Analysis based on randomized subjects in the Safety population; all subjects who received at least 1 dose of study medication and were randomized into double-blind treatment.|||days||Standard Deviation|Mean
2654693|NCT01633944|Secondary|Number of Subjects With Rescue Medication Use|Use of analgesic rescue medication recorded in subject diary.|Week 1 to Week 12 in double-blind treatment|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population.|||participants|||Number
2654694|NCT01633944|Secondary|Number of Participants With Response to Treatment (Responder) Using NRS Scale|Responders are subjects who achieve a relative reduction in pain intensity from the start of open-label titration to Week 12 in double-blind treatment. Average pain intensity over the last 24 hours was rated on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain imaginable).|Prior to open-label titration to Week 12 in double-blind treatment|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population.|||participants|||Number
2654695|NCT01633944|Primary|Change From Baseline to Week 12 in Average Daily Pain Intensity Scores|Change in pain intensity = average of daily pain scores from the last 7 days prior to Week 12 visit - average of daily pain scores for the last 7 days prior to randomization. Average pain intensity over the last 24 hours was rated on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).|Baseline, Week 12|Analysis based on ITT population; all randomized subjects who received at least 1 dose of double-blind study medication. One (1) subject did not receive double-blind study medication and an additional 41 subjects from 1 site were excluded from the population.|||units on a scale||Standard Deviation|Mean
2654696|NCT01633892|Secondary|Characterization of Adipose Stromal Cell (ASC) Function|Cell assessment will include viable stromal vascular fraction per gram of lipoaspirate.|time of surgery, up to 12 hours post-baseline||||mL of viable SVF per g of lipoaspirate||Standard Deviation|Mean
2654697|NCT01633892|Secondary|Composition of SVF|Cell assessment included stromal vascular fraction composition evaluated by flow cytometry.|time of fat grafting, up to 12 hours post-baseline||||percentage of cells||Standard Deviation|Mean
2654698|NCT01633892|Secondary|Measure Quality of Life in Subjects After Grafting Using Validated Psychosocial Measures.|"1) Social Avoidance and Distress Scale (SADS) uses a questionnaire including 28 true/false items, with scores ranging from 0-10. A low score is below 4, high is above 7; intermediate is between 4-7. 2) COPE scale asks the subject to indicate what he/she generally does and feels, when he/she experience stressful events. On a scale of 60-240 where the higher ends indicates the subject does this activity most frequently during stressful events; 3) The Satisfaction With Appearance Scale (SWAP) is a 14-item questionnaire, assessing both the subjective appraisal and social-behavioral components of body image, where the higher the score, the more satisfied subject is with procedure, ranging from 0-7 for a total possible score range between 0-98 ."|9 months||||units on a scale, see outcome measure de||Standard Deviation|Mean
2654699|NCT01633892|Primary|Average Tissue Thickness From Baseline up to 9 Months|High resolution CT scanning with 3D reconstruction at 0, 1, 3, and 9 months|0, 1, 3, and 9 months||||mm||Standard Deviation|Mean
2654700|NCT01633892|Primary|Average Fat Graft Volume Facial Form From Baseline up to 9 Months|High resolution CT scanning with 3D reconstruction at 0, 1, 3, and 9 months|0, 1, 3, and 9 months||||cc||Standard Deviation|Mean
2654707|NCT01633827|Primary|Model Prediction of Absence/Presence of OSA: Active Collapsibility (Vactive)|"Our published method estimates 4 important physiological traits causing OSA: 1) pharyngeal anatomy, 2) loop gain, 3) the ability of the upper airway to dilate/stiffen in response to increases in ventilatory drive, and 4) arousal threshold. Each individual's set of traits is then entered into a physiological model of OSA that graphically illustrates the relative importance of each trait in that individual and predicts OSA presence/absence.~Active collapsibility is the ventilation on no CPAP when upper airway muscle are maximally activated. It is calculated by slowing reducing CPAP from the optimal to the minimum tolerable level and rapidly dropping the CPAP to 0 for a few breaths. This trait is symbolized as Vactive (L/min)"|Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2)|During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject results for the 20 remaining patients are reported here per intervention.|||L/min||Standard Error|Mean
2654708|NCT01633827|Primary|Model Prediction of Absence/Presence of OSA: Passive Collapsibility|"Our published method estimates 4 important physiological traits causing OSA: 1) pharyngeal anatomy, 2) loop gain, 3) the ability of the upper airway to dilate/stiffen in response to increases in ventilatory drive, and 4) arousal threshold. Each individual's set of traits is then entered into a physiological model of OSA that graphically illustrates the relative importance of each trait in that individual and predicts OSA presence/absence.~The passive collapsibility of the upper airway is quantified as the ventilation on no CPAP (atmospheric pressure) at the eupneic level of ventilatory drive when upper airway dilator muscles are relatively passive. This trait is symbolized as Vpassive (L/min)"|Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2)|During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject results for the 20 remaining patients are reported here per intervention.|||L/min||Standard Error|Mean
2654709|NCT01633827|Primary|Model Prediction of Absence/Presence of OSA: Ventilatory Control Sensitivity (Loop Gain)|"Our published method estimates 4 important physiological traits causing OSA: 1) pharyngeal anatomy, 2) loop gain, 3) the ability of the upper airway to dilate/stiffen in response to increases in ventilatory drive, and 4) arousal threshold. Each individual's set of traits is then entered into a physiological model of OSA that graphically illustrates the relative importance of each trait in that individual and predicts OSA presence/absence.~In this table the investigators report the ventilatory control sensitivity value (Loop Gain). It is calculated dividing the increase in ventilatory drive by the steady state reduction in ventilation. The increase in ventilatory drive is measured as the ventilatory overshoot following a switch to optimal CPAP from the minimum tolerable CPAP. This trait is symbolized as steady state loop gain (LG, adimensional)"|Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2)|During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject results for the 20 remaining patients are reported here per intervention.|||ratio, adimensional||Standard Error|Mean
2654710|NCT01633827|Primary|Model Prediction of Absence/Presence of OSA: Ventilation That Causes an Arousal From Sleep (Varousal)|"Our published method estimates 4 important physiological traits causing OSA: 1) pharyngeal anatomy, 2) loop gain, 3) the ability of the upper airway to dilate/stiffen in response to increases in ventilatory drive, and 4) arousal threshold. Each individual's set of traits is then entered into a physiological model of OSA that graphically illustrates the relative importance of each trait in that individual.~In this table the investigators report the minimum ventilation that can be tolerated before an arousal from sleep (Varousal). It is calculated by slowly reducing the CPAP level from optimum to the minimum tolerable pressure. This trait is symbolized as Varousal (L/min)"|Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2)|During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject results for the 20 remaining patients are reported here per intervention.|||L/min||Standard Error|Mean
2654711|NCT01633814|Primary|Change in Exercise Pressor Reflex Responsiveness (Mean Blood Pressure Response (mmHg) and Muscle Sympathetic Nerve Activity Response (Burst Frequency) During Post Handgrip Ischemia.)|To estimate exercise pressor reflex responsiveness changes in blood pressure and muscle sympathetic nerve activity from rest to during a period of post handgrip ischemia will be used.|Within one week prior to and then after one month of transdermal estrogen alone, transdermal estrogen plus progesterone, progesterone alone and placebo.|Results are not available due to all members of the study having left the institution and not having made results available.||||||
2654712|NCT01633814|Primary|Change in Carotid Baroreflex Sensitivity (Bpm/mmHg)|Carotid baroreflex sensitivity will be measured using the application of neck pressure and neck suction. Briefly, a variable neck pressure collar will be placed around the anterior two thirds of the neck to change carotid sinus transmural pressure.|Within one week prior to and then after one month of transdermal estrogen alone, transdermal estrogen plus progesterone, progesterone alone and placebo.|Results are not available due to all members of the study having left the institution and not having made results available.||||||
2654713|NCT01633788|Secondary|Percentage of Complete Overall Ocular Discomfort Responders|Ocular symptoms of blurred vision, burning, dryness, eye pain, light sensitivity, itching, and foreign body sensation are assessed by the patient on a 5-point scale ranging from 0 = none to 4 = very severe. A patient is considered a complete overall ocular discomfort responder if the overall ocular discomfort score is 0 (indicating no overall ocular discomfort) at that visit.|Month 6|Modified intent-to-treat: all randomized and treated patients who have values for meibum quality score at randomization, at least one postrandomization visit, and data at the noted time point|||Percentage of Patients|||Number
2654714|NCT01633788|Secondary|Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye|The MQS is assessed based on Mathers' meibum quality secretion grading 4-point scale where: 0 = Clear excreta or clear with small particles (normal viscosity), 1 = Opaque excreta with normal viscosity, 2 = Opaque excreta with increased viscosity (gel-like), and 3 = Secretions retain shape (or secretions do not express but a toothpaste-like substance can be seen at the opening of the orifice). MMQS is calculated for each eye as the maximum of the meibum quality scores of the expressible glands within the 6 central glands of the lower eyelids. A patient is considered to be an MMQS responder at a postrandomization visit if the MMQS in the study eye is 0 or 1 (indicating normal viscosity) at that visit.|Month 6|Modified intent-to-treat: all randomized and treated patients who have values for meibum quality score at randomization, at least one postrandomization visit, and data at the noted time point|||Percentage of Patients|||Number
2654715|NCT01633788|Primary|Percentage of Meibum Quality Responders in the Study Eye|Meibum quality response is defined as a patient who experiences a reduction ≥ 50% in the number of meibomian glands with a Meibum Quality Score (MQS) of 2 or 3 in the study eye. The MQS is based on Mathers' meibum quality secretion grading 4-point scale where: 0 = Clear excreta or clear with small particles (normal viscosity), 1 = Opaque excreta with normal viscosity, 2 = Opaque excreta with increased viscosity (gel-like), and 3 = Secretions retain shape (or secretions do not express but a toothpaste-like substance can be seen at the opening of the orifice).|Month 6|Modified intent-to-treat: all randomized and treated patients who have values for meibum quality score at randomization, at least one postrandomization visit, and data at the noted time point|||Percentage of Patients|||Number
2654716|NCT01633320|Primary|Pain Scores on a 0-10 Numeric Rating Scale (NRS)|Verbal pain scale, with 0 = no pain and 10 = worst pain imaginable. NRS<3 corresponds to no or mild pain NRS>=3 corresponds to moderate to severe pain NRS>=7 corresponds to severe pain|At arrival in PACU or 10 min after extubation||||units on a scale||Standard Deviation|Mean
2654717|NCT01633320|Primary|Analgesia/Nociception Index (ANI)|The ANI is a 0-100 index estimating the parasympathetic/sympathetic balance derived from heart rate variability, measured by the PhysioDoloris monitor (MetroDoloris, Loos, France). High ANI values indicate parasympathetic predominance (no pain) while during nociception (increase in sympathetic activity), ANI value decrease to 60 or less.|At arrival in post-operative care unit (PACU) or 10 min after extubation||||units on a scale||Standard Deviation|Mean
2654718|NCT01633112|Secondary|Percent Brain Volume Change From Baseline|Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans were performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.|Baseline, 12 months, end of study|Full-analysis set: All subjects who were randomly assigned and took at least 1 dose of study drug. Following the intent-to-treat principle, subjects were grouped according to the assigned treatment at randomization. Efficacy analyses were performed using the full analysis set unless otherwise notified.|||Percentages of volume change||Standard Deviation|Mean
2654719|NCT01633112|Secondary|Change From Baseline in TSQM Scales|Treatment Satisfaction Questionnaire for Medication (TSQM) was developed and validated as a general measure for treatment satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0—100 scale. Higher summary scores indicate better satisfaction with study drug.|6 months, 12 months/end of study|Full-analysis set: All subjects who were randomly assigned and took at least 1 dose of study drug. Following the intent-to-treat principle, subjects were grouped according to the assigned treatment at randomization. Efficacy analyses were performed using the full analysis set unless otherwise notified.|||score on a scale||Standard Deviation|Mean
2654720|NCT01633112|Secondary|Percentage of Patients Free of New T1 Hypointense Lesions|Based on MRI measures of new T1 hypointense lesions|12 months|Full-analysis set: All subjects who were randomly assigned and took at least 1 dose of study drug. Following the intent-to-treat principle, subjects were grouped according to the assigned treatment at randomization. Efficacy analyses were performed using the full analysis set unless otherwise notified.|||Percentage|||Number
2654721|NCT01633112|Secondary|Gd Enhancing T1 Lesion Volume|Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count|Baseline, 12 months/end of study|Full-analysis set: All subjects who were randomly assigned and took at least 1 dose of study drug. Following the intent-to-treat principle, subjects were grouped according to the assigned treatment at randomization. Efficacy analyses were performed using the full analysis set unless otherwise notified.|||cubic centimeter||Standard Deviation|Mean
2654722|NCT01633112|Secondary|Gd Enhancing T1 Lesion Count|Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count|At 12 months/end of study|Full-analysis set: All subjects who were randomly assigned and took at least 1 dose of study drug. Following the intent-to-treat principle, subjects were grouped according to the assigned treatment at randomization. Efficacy analyses were performed using the full analysis set unless otherwise notified.|||lesions||Standard Deviation|Mean
2654723|NCT01633112|Secondary|Change From Baseline in T2 Lesion Volume|Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion volume|Baseline, 12 months/end of study|Full-analysis set: All subjects who were randomly assigned and took at least 1 dose of study drug. Following the intent-to-treat principle, subjects were grouped according to the assigned treatment at randomization. Efficacy analyses were performed using the full analysis set unless otherwise notified.|||cubic centimeters (cc)||Standard Deviation|Mean
2654724|NCT01633112|Secondary|Number of Participants Free of New/Newly Enlarged T2 Lesions|Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.|At 12 months/end of study|Full-analysis set: All subjects who were randomly assigned and took at least 1 dose of study drug. Following the intent-to-treat principle, subjects were grouped according to the assigned treatment at randomization. Efficacy analyses were performed using the full analysis set unless otherwise notified.|||Participants|||Number
2654725|NCT01633112|Secondary|New or Newly Enlarging T2 Lesions|Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.|At 12 months/end of study|Full-analysis set: All subjects who were randomly assigned and took at least 1 dose of study drug. Following the intent-to-treat principle, subjects were grouped according to the assigned treatment at randomization. Efficacy analyses were performed using the full analysis set unless otherwise notified.|||Lesions||Standard Deviation|Mean
2654726|NCT01633112|Primary|Confirmed Annualized Relapse Rate|Annualized relapse rate (ARR) was defined as the average number of confirmed relapses per year (i.e., the total number of confirmed relapses divided by the total days in the study multiplied by 365.25). The number of relapses included all the confirmed relapses experienced during the study from first dose to end of study.|up to 12 months|Full-analysis set: All subjects who were randomly assigned and took at least 1 dose of study drug. Following the intent-to-treat principle, subjects were grouped according to the assigned treatment at randomization. Efficacy analyses were performed using the full analysis set unless otherwise notified.|||relapses/year||95% Confidence Interval|Number
2654765|NCT01632709|Secondary|Change in Depression (CES-D 10)|The Center for Epidemiologic Studies Short Depression Scale (CES‐D 10) is a validated instrument that assesses depression. The CES-D 10 is a scale from 0-30 where 0= no depression and 30=the most depression|CES-D 10 collected pre injection and 1 week post injection|all available data was analyzed (some subjects did not complete all outcomes)|||units on a scale||Standard Deviation|Mean
2654727|NCT01633060|Secondary|Time to Definitive Deterioration of ECOG Performance Status From Baseline - Full Analysis Set (FAS)|The Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. The ECOG Performance Scores has 5 grades: 0 = fully active, able to carry on all pre-disease performance without restriction, 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work, 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours, 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours, 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair and 5 = dead. Definitive deterioration is defined as no improvement in the ECOG status following observation of the deterioration.|Screening, Baseline (Cycle 1 Day 1) and then at day 1 of each cycle and at the EOT visit|Full Analysis (FAS) based on Primary Analysis|||Months||95% Confidence Interval|Median
2654728|NCT01633060|Secondary|Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Global Health Status/Quality of Life Per EORTC-QLQ-C30 - Full Analysis Set (FAS)|The global health status/QoL scale score of the QLQ-C30 is identified as the primary PRO variable of interest. Physical Functioning (PF), Emotional Functioning (EF) and Social Functioning (SF) scale scores of the QLQ-C30. The time to definitive 10% deterioration is defined as the time from the randomization date to the date of an event, which is defined as a worsening (decrease) in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study or death due to any cause. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high /healthy level of functioning, a high score for the global health status / QoL represents a high QoL.|Baseline, Week 6 (C2D15), Week 12 (C4D1), then every 8 weeks until discontinuation (a cycle [C] = 4 weeks) up to 5 years.|Full Analysis (FAS) based on Primary Analysis|||Months||95% Confidence Interval|Median
2654729|NCT01633060|Secondary|Predose Trough Concentration-time Profile of BKM120 in Combination With Fulvestrant Over Time - Pharmacokinetic Analysis Set (PAS)|Pre-dose samples were collected for trough concentrations at Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1 and Cycle 4 Day 1.|C1D15, C2D1, C3D1 and C4D1|Pharmacokinetic Analysis Set (PAS) based on Primary Analysis|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2654730|NCT01633060|Secondary|Plasma Concentration-time Profiles of BKM120 in Combination With Fulvestrant at Cycle 1 Day 1 - Pharmacokinetic Analysis Set (PAS)|Plasma samples were collected from the first 100 BKM120-treated patients on Cycle 1 Day 1 (at 1h, 2h, and 6h post-dose and a recommended 9h post-dose sample).|C1D1 1 hour post dose, C1D1 2 hour post dose, C1D1 6 hour post dose and C1D1 9 hour post dose|Pharmacokinetic Analysis Set (PAS) based on Primary Analysis|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2654731|NCT01633060|Secondary|Long-term Safety and Tolerability in the Two Treatment Arms - Safety Set (SS)|Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths.|From first dose of study treatment to 30 days after last dose of study treatment, up to 5 years|Safety Set (SS) based on Final Analysis|||Percentage of Participants|||Number
2654732|NCT01633060|Secondary|Clinical Benefit Rate (CBR) by PIK3CA Mutational Status|Clinical Benefit Rate (CBR) is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) or stable disease (SD) or Non-CR/non-PD lasting more than 14 or 24 weeks based on local investigator's assessment according to RECIST 1.1. CBR was analyzed in the full population and by PIK3CA mutational status based on ctDNA. Patients were followed up for the duration of the study and approximately every 6 weeks after randomization.|Week 14, Week 24|Full Analysis Set (FAS), Full Analysis Set (FAS) -ctDNA PIK3CA mutant, Full Analysis Set (FAS) - ctDNA PIK3CA non-mutant based on Primary Analysis.|||Percentage of Participants||95% Confidence Interval|Number
2654733|NCT01633060|Secondary|Overall Response Rate (ORR) by PIK3CA Mutational Status|Overall Response Rate (ORR) is defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST 1.1. ORR was analyzed in the full population and by PIK3CA mutational status based on ctDNA. Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target/non target lesions: Complete Response (CR), disappearance of all target/non target lesions (all lymph nodes assigned as non-target lesions must be non-pathological in size (< 10 mm short axis)); Partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions ; Overall Response (OR)= CR+PR. Patients were followed up for the duration of the study and for approximately every 6 weeks after randomization.|Every 6 weeks after randomization up to a maximum of 5 years|Full Analysis Set (FAS), Full Analysis Set (FAS) -ctDNA PIK3CA mutant, Full Analysis Set (FAS) - ctDNA PIK3CA non-mutant based on Primary Analysis.|||Percentage of Participants||95% Confidence Interval|Number
2654734|NCT01633060|Secondary|Overall Survival (OS) by PIK3CA Mutational Status|Overall Survival (OS) by PIK3CA mutational status based on ctDNA is defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last known date patient alive. Patients were followed up approximately every 6 weeks after randomization and every 3 months during survival follow-up.|Every 6 weeks after randomization up to a maximum of 5 years|Full Analysis Set (FAS) -ctDNA PIK3CA mutant, Full Analysis Set (FAS) - ctDNA PIK3CA non-mutant based on Primary Analysis.|||Months||95% Confidence Interval|Median
2654751|NCT01632891|Secondary|Change in log10(Pf Gametocyte Density) From Entry to Day 30|"Change in log10(Pf gametocyte density) as evaluated using a Hodges-Lehmann estimate from entry to day 30 is evaluated in two groups:~Randomized to nNRTI‐based ART with continued Pf SCP at day 15~Randomized to LPV/r‐based ART with continued Pf SCP at day 15~Analysis was not conducted in either group with clearance at day 15 due to the small sample size and high number of undetectable samples in both clearance groups at entry and day 30."|Entry, Day 30|"All participants with results available at both entry and day 30 who did not have Pf SCP clearance at day 15.~participant was missing from the nNRTI-based ART, not cleared group~participants were missing from the LPV/r-based ART, not cleared group"|||log10(gametocyte/µL)||95% Confidence Interval|Number
2657196|NCT01607853|Secondary|Change From Baseline in Erythema at Day 11|Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 11||||units on a scale||Standard Deviation|Mean
2654735|NCT01633060|Secondary|Progression Free Survival (PFS) by PIK3CA Mutational Status|Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm. Patients were followed up for approximately every 6 weeks after randomization.|Every 6 weeks after randomization up to a maximum of 5 years|Full Analysis Set (FAS) -ctDNA PIK3CA mutant, Full Analysis Set (FAS) - ctDNA PIK3CA non-mutant based on Primary Analysis.|||Months||95% Confidence Interval|Median
2654736|NCT01633060|Secondary|Overall Survival (OS) - Full Analysis Set (FAS)|Overall Survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last known date patient alive. Patients were followed up approximately every 6 weeks after randomization and every 3 months during survival follow-up.|Every 6 weeks after randomization up to a maximum of 5 years|Full Analysis Set (FAS) based on Primary Analysis.|||Months||95% Confidence Interval|Median
2654737|NCT01633060|Primary|Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS)|Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm. Patients were followed up for approximately every 6 weeks after randomization.|Every 6 weeks after randomization up to a maximum of 4 years|Full Analysis Set (FAS) based on Primary Analysis.|||Months||95% Confidence Interval|Median
2654738|NCT01632995|Secondary|Measurement of HIV Drug Resistance Patterns Among Participants Who Become Infected||Participants were followed for 48 weeks, or up to the point of early termination||||participant with acquired HIV resistance|||Number
2654739|NCT01632995|Secondary|Number of Participants Who Seroconvert||Participants were followed for 48 weeks, or up to the point of early termination||||participants|||Number
2654740|NCT01632995|Primary|Measurement of PrEP Adherence by Medication Possession Ratio|Medication possession ratio is defined as the number of dispensed pills divided by the number of days between visits|Participants were followed for 48 weeks, or up to the point of early termination|Mean PrEP adherence by medication possession ratio|||percent|||Number
2654741|NCT01632995|Primary|Number of Male Sexual Partners||Participants were followed for 48 weeks, or up to the point of early termination||||partners||Full Range|Mean
2654742|NCT01632995|Primary|Measurement of PrEP Adherence by TFV-DP Levels in DBS||Participants were followed for 48 weeks, or up to the point of early termination|DBS testing was performed in approximately 100 randomly selected participants per site, and among all African American and transgender participants, who were underrepresented in the overall sample|||Percent of Participants|||Number
2654743|NCT01632995|Primary|Measurement of Side Effects/Toxicities||Participants were followed for 48 weeks, or up to the point of early termination||||events|||Number
2654744|NCT01632995|Primary|Duration of PrEP Use|Mean duration of interruptions|Participants were followed for 48 weeks, or up to the point of early termination||||Days|||Number
2654745|NCT01632995|Primary|Duration of PrEP Use|Number of study drug interruptions|Participants were followed for 48 weeks, or up to the point of early termination||||interruptions|||Number
2654746|NCT01632995|Primary|Measurement of Refusal Rate of PrEP||Measured through enrollment (Week 0)||||Participants|||Count of Participants
2654747|NCT01632995|Primary|Measurement of Acceptance Rate of PrEP||Measured through enrollment (Week 0)||||Participants|||Count of Participants
2654748|NCT01632904|Secondary|Proportion of Subjects Randomized to Ruxolitinib Who Achieved ≥ 50% Improvement From Baseline in Total Symptom Score-Cytokine and the Individual Symptom Scores at Week 16 That Were Maintained at Week 48|Durable Response on TSS-C/individual symptoms defined as a ≥ 50% reduction in TSS-C/individual symptoms at Week 16 that were maintained at Week 48|Week 48|Intent-to-Treat (ITT); all subjects randomized to Ruxolitinib in the study. For TSS-C/individual symptoms, subject without baseline value was excluded from the analysis.|||percentage of participants||95% Confidence Interval|Number
2654749|NCT01632904|Secondary|Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16|The TSS-C cluster includes tiredness, itching, muscle aches, night sweats, and sweats while awake.|From Baseline to Week 16|Intent-to-Treat (ITT); all subjects randomized in the study. For individual symptom scores within the TSS-C cluster, only those subjects with a baseline score of 0 and a Week 16 score of 0 or missing were excluded from the analysis.|||Percentage of participants|||Number
2654750|NCT01632904|Primary|Percentage of Subjects Achieving a ≥ 50% Improvement From Baseline in Total Symptom Score-Cytokine (TSS-C) at Week 16, as Measured by the Modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Diary|Symptoms of polycythemia vera were assessed using a modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) electronic diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): tiredness, itching, muscle aches, night sweats, and sweats while awake. The total symptom score ranged from 0-50 and was calculated as the sum of the 5 symptom scores. A higher score indicates worse symptoms.|From Baseline to Week 16|Intent-to-Treat (ITT); all subjects randomized in the study. For the overall TSS-C score, only those subjects with a baseline score of 0 and a Week 16 score of 0 or missing were excluded from the analysis.|||Percentage of participants|||Number
2654752|NCT01632891|Secondary|Number of Participants With Detectable Pf Gametocyte Density|Number of participants with detectable Pf gametocyte density as determined by PCR. Due to the large number of undetectable results, this outcome was measured as dichotomous.|Entry, days 3, 6, 9, 12, 15, 20, 25, 30|"Analysis only includes participants who received 15 days of treatment, excluding one participant on LPV/r-based ART.~One other participant on LPV/r-based ART had missing data at all time points. Several samples were missing at various time points, as shown by number of participants for each day."|||Participants|||Count of Participants
2654753|NCT01632891|Secondary|Number of Participants With Uncomplicated Clinical Malaria|Uncomplicated clinical malaria is defined as the presence of non-severe fever/symptoms and parasitemia without organ complication.|From study entry to day 30|All participants.|||Participants|||Count of Participants
2654754|NCT01632891|Secondary|Change in log10(Pf Parasite Density) From Entry to Day 30|"Change is evaluated as log10(Pf parasite density) at day 30 minus log10(Pf parasite density) at entry.~Change is evaluated in four groups:~Randomized to nNRTI‐based ART with continued Pf SCP at day 15~Randomized to nNRTI‐based ART with clearance of Pf SCP at day 15~Randomized to LPV/r‐based ART with continued Pf SCP at day 15~Randomized to LPV/r‐based ART with clearance of Pf SCP at day 15"|Entry, Day 30|"All participants enrolled with results available at entry and day 30:~3 participants were missing data in 'nNRTI-based ART, not cleared' group.~1 participant was missing data in 'nNRTI-based ART, cleared' group.~1 participant was missing data in 'LPV/r-based ART, not cleared' group."|||log10(parasites/µL)||Inter-Quartile Range|Median
2654755|NCT01632891|Secondary|Log10(Pf Parasite Density)|Pf parasite density was determined by PCR. If parasite density equals 0, the value is set to 0.01 before log10 transformation. The value 0.01 was chosen based on the smallest observed parasite density value of 0.017.|Entry, days 3, 6, 9, 12, 15, 20, 25, 30|"Analysis only includes participants who received 15 days of treatment, excluding one participant on LPV/r-based ART.~One participant on nNRTI-based ART had missing data at all time points. Several samples were missing at various time points, as shown by number of participants for each day."|||log10(parasites/µL)||95% Confidence Interval|Mean
2654756|NCT01632891|Secondary|Time to First Pf SCP Clearance|Time to clearance is defined by time to first measurement with PCR < 10 parasites/µL, and is evaluated as the point estimate and 95% CI for the day when 50% of participants cleared parasite.|From study entry up to day 30|"Analysis only includes participants who received 15 days of treatment, excluding one participant on LPV/r-based ART.~One participant on nNRTI-based ART had missing data at all time points."|||Days||95% Confidence Interval|Median
2654757|NCT01632891|Primary|Proportion of Participants With Plasmodium Falciparum (Pf) Subclinical Parasitemia (SCP) Clearance|"Pf SCP clearance defined by polymerase chain reaction (PCR) < 10 parasites/µL on three consecutive occasions within a 24-hour period.~If a participant had missing data on day 15, they were considered as not having clearance."|Day 15 (3 samples collected, separated by at least 5 hours and all three collected within 24-hours)|Primary analysis is based on intent-to-treat principles and includes all randomized participants.|||Proportion of participants|||Number
2654758|NCT01632878|Primary|Number of Occurrences of Cardio-vascular Events|Such as: recurrent non fatal Myocardial Infarction (MI), sudden death, or new Congestive Heart Failure (CHF)|12 months||||events|||Number
2654759|NCT01632800|Primary|Degree of Discomfort Under Applied Pulsed Magnetic Fields|Pulsed magnetic fields will be applied a total of forty-eight times to the right hand of each subject. After each time the magnet coil is pulsed, the subject will be asked if he or she notices any sensation (for example, tingling or tapping). Subjects will be asked to rate the sensation from 0 to 4, where 0 means no sensation, 1 means barely-noticeable sensation, 2 means easily noticeable sensation, 3 means unpleasant sensation, and 4 means very unpleasant sensation.|Bioeffects will be assessed within the five-minute application of each pulse sequence||||percentage of subjects with discomfort|||Number
2654760|NCT01632735|Secondary|Social Support Utilization|"Self-help utilization was measured by the question: In the past 30 days, how many days did you attend self-help meetings like AA or NA to support your recovery?"|Baseline, discahrge, 3 month follow-up, 6 month follow-up, 9 month follow-up|Intent to treat model was used to assess the effects of the intervention (mobile continuing care) compared to aftercare as usual in terms of improvements in social support service utilization over time (baseline, discharge and follow-ups: 3-, 6- and 9-months post-discharge).|||days per month||Standard Deviation|Mean
2654761|NCT01632735|Secondary|Recovery Confidence (Self-efficacy) Over Time|"Change/improvements in mean recovery confidence score over time (measured by question How confident are you in your ability to be completely abstinent (clean) from alcohol and drugs in the next 30 days? (units on scale included 0=not at all, 1=slightly, 2=moderately, 3=considerably, 4-extremely)."|baseline, discharge, 3-, 6-, and 9-month follow-ups|Used an intent to treat design. Examined the effects of the intervention (mobile continuing care) compared to aftercare as usual on change in recovery self-confidence over time.|||units on a scale||Standard Deviation|Mean
2654762|NCT01632735|Secondary|Participation in Recovery Behaviors Over Time|Recovery behaviors defined as mean number of days doing extracurricular/recovery-goal directed activities using repeated measures over time.|baseline, discharge, 3-, 6- and 9-month follow-ups|Intent to treatment model was used. Mixed modeling used to examine differences in recovery behaviors (measured by mean days doing extracurricular/recovery-goal directed activities) over time between study conditions.|||days per month||Standard Deviation|Mean
2654763|NCT01632735|Primary|Primary Substance Use (Defined as Substance Received Treatment for)|Primary substance use relapse was measured by urine tests (0 = negative, 1 = positive).|Baseline, discahrge, 3 month follow-up, 6 month follow-up, 9 month follow-up|An intent to treat model was used. The primary outcome measure is primary substance use measured by urine drug test at baseline, discharge as well as at 3-, 6-, and 9-month follow-ups. Study retention at discharge was 95%, 92.5% at 3 months, 86.2% at 6 months, and 82.5% at 9 months.|||percentage of positive urines|||Number
2654764|NCT01632709|Secondary|Pain Visual Analogue Scale (VAS)|The Pain Visual Analogue Scale (VAS) is a scale from 0-100 where 0= no pain and 100=the worst pain|VAS collected pre injection and 1 week post injection|all available data was analyzed (some subjects did not complete all outcomes)|||units on a scale||Standard Deviation|Mean
2654766|NCT01632709|Secondary|Change in Perceived Anxiety (PASS)|The Pain Anxitey Symptoms Scale (PASS) is a validated instrument that assesses anxiety in.The PASS is a scale from 0-100 where 0= no anxiety and 100=the most anxiety|PASS collected pre injection and 1 week post injection|all available data was analyzed (some subjects did not complete all outcomes)|||units on a scale||Standard Deviation|Mean
2654769|NCT01632683|Secondary|Number of Participants With Observed Complications|Patients will be examined for evidence of mucosal or dental injury upon intervention. Patients will be asked if they have a sore throat in the recovery room, and their medical record will be reviewed to determine if any other airway related complications were observed by the clinical team including the need for reintubation or steroid administration to reduce swelling.|1 week||||Participants|||Count of Participants
2654770|NCT01632683|Secondary|Number of Particpants Requiring Adjuncts to Assist Intubation|The need for use of a gum-elastic bougie or external laryngeal manipulation to facilitate tube placement will be measured by the study team.|1 week||||Participants|||Count of Participants
2654771|NCT01632683|Secondary|Graded Score of Laryngeal View Achieved|Laryngeal view is defined by the modified Cormack and Lehane scale (1-4) and is assessed by the clinician and the study team. Grade 1 is considered to be a good view while grade 4 is considered to be a poor view.|1 week|Cormack-Lehane grade|||participants|grade||Number
2654772|NCT01632683|Secondary|Intubation Time|Intubation time is defined as the time from blade insertion to first return of end-tidal carbon dioxide|1 week||||seconds||Inter-Quartile Range|Mean
2654773|NCT01632683|Primary|Intubation Success Rate|Success rate is defined as a single blade insertion with successful tracheal tube placement confirmed by return of end-tidal carbon dioxide|1 week||||participants|||Number
2654774|NCT01632579|Secondary|Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Thromboxane A Metabolite (TXAM)|Urinary excretion of TXAM, after correcting for urinary creatinine. TXAM was corrected for urinary creatinine by dividing the picograms per milliliter (pg/mL) of metabolite excreted in urine by the concentration of creatinine [milligrams per milliliter (mg/mL)] in urine. Percent change from baseline of urinary excretion of TXAM=(mg creatinine per pg of metabolite excreted in urine postdose-mg of creatinine per pg of metabolite excreted at baseline)/mg of creatinine per pg of metabolite excreted at baseline*100.|Baseline, 0 to 2 hours (h), 2 to 4 h, 4 to 6 h, and 6 to 12 h post-dose|All participants who received at least 1 dose of study drug or placebo and had evaluable TXAM data at specific time points.|||percent change in TXAM||Inter-Quartile Range|Median
2654775|NCT01632579|Secondary|Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostacyclin Metabolite (PGIM)|Urinary excretion of PGIM, after correcting for urinary creatinine. PGIM was corrected for urinary creatinine by dividing the picograms per milliliter (pg/mL) of metabolite excreted in urine by the concentration of creatinine [milligrams per milliliter (mg/mL)] in urine. Percent change from baseline of urinary excretion of PGIM=(mg creatinine per pg of metabolite excreted in urine postdose-mg of creatinine per pg of metabolite excreted at baseline)/mg of creatinine per pg of metabolite excreted at baseline*100.|Baseline, 0 to 2 hours (h), 2 to 4 h, 4 to 6 h, and 6 to 12 h post-dose|All participants who received at least 1 dose of study drug or placebo and had evaluable PGIM data at specific time points.|||percent change in PGIM||Inter-Quartile Range|Median
2654776|NCT01632579|Secondary|Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostaglandin E(2) Metabolite (PGEM)|Urinary excretion of PGEM, after correcting for urinary creatinine. PGEM was corrected for urinary creatinine by dividing the picograms per milliliter (pg/mL) of metabolite excreted in urine by the concentration of creatinine [milligrams per milliliter (mg/mL)] in urine. Percent change from baseline of urinary excretion of PGEM=(mg creatinine per pg of metabolite excreted in urine postdose-mg of creatinine per pg of metabolite excreted at baseline)/mg of creatinine per pg of metabolite excreted at baseline*100.|Baseline, 0 to 2 hours (h), 2 to 4 h, 4 to 6 h, 6 to 12 h, and 12 to 24 hours post-dose|All participants who received at least 1 dose of study drug or placebo and had evaluable PGEM data at specific time points.|||percent change in PGEM||Inter-Quartile Range|Median
2654777|NCT01632579|Secondary|Pharmacodynamics: Percent Change From Baseline of ex Vivo Whole Blood Prostaglandin E (PGE) Synthesis After Lipopolysaccharide (LPS) Stimulation|Percent change from baseline of PGE synthesis=(postdose PGE synthesis-baseline PGE synthesis)/baseline PGE synthesis*100, where the unit of measure for PGE synthesis is nanograms per milliliter (ng/ml).|Baseline, 0.5 hours (h), 1 h, 2 h, 8 h, 24 h, and 144 h post-dose|All participants who received at least 1 dose of study drug or placebo and had evaluable PGE data at the specific time points.|||percent change in PGE||Inter-Quartile Range|Median
2654778|NCT01632579|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3023703|Area under the concentration time curve from the time of dosing to the time of the last observation.|Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 8 and 12 hours, post-dose|Pharmacokinetic (PK) population: All participants who received at least 1 dose of study drug and had evaluable AUC data.|||hour*nanograms per milliliter (hr*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2654779|NCT01632579|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY3023703||Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 8 and 12 hours, post-dose|Pharmacokinetic (PK) population: participants who received at least 1 dose of study drug and had evaluable Cmax data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2654780|NCT01632579|Primary|Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AE|AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible study drug relatedness, is located in the Reported Adverse Events module.|Baseline up to Day 7 post-dose|Safety population: participants who received at least 1 dose of study drug or placebo, whether or not he/she completed all the protocol requirements.|||Participants|||Count of Participants
2654781|NCT01632566|Secondary|Change From Baseline to Day 28 in Urinary Thromboxane A (TXA) Metabolite Excretion||Baseline, Predose up to 12 hours prior to last dose at Day 28|Zero participants were analyzed. Data not collected.||||||
2654782|NCT01632566|Secondary|Change From Baseline to Day 28 in Urinary Prostaglandin E (PGE) Metabolite Excretion||Baseline, Predose up to time of last dose at Day 28|Zero participants were analyzed. Data not collected.||||||
2654783|NCT01632566|Secondary|Change From Baseline to Day 28 in Urinary Prostacyclin I (PGI) Metabolite Excretion||Baseline, Predose up to 12 hours prior to last dose at Day 28|Zero participants were analyzed. Data not collected.||||||
2654784|NCT01632566|Secondary|Pharmacokinetics: Time of Maximum Concentration (Tmax) of Simvastatin||Predose up to 48 hours post dose at Day -3 and Day 28|Participants dosed with 75 mg LY3031207 from Days 1 through 28 and with oral administration of 10 mg open-label simvastatin on Days -3 and 28 and who had complete pharmacokinetic profiles following both simvastatin dosing events. Participants who had incomplete data due to early discontinuation were not analyzed.|||hours||Full Range|Median
2654785|NCT01632566|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of Simvastatin|Area under the concentration versus time curve over the range of all measureable concentrations (AUC[0-tlast]) of simvastatin.|Predose up to 48 hours post dose at Day -3 and Day 28|Participants dosed with 75 mg LY3031207 from Days 1 through 28 and with oral administration of 10 mg open-label simvastatin on Days -3 and 28 and who had complete pharmacokinetic profiles following both simvastatin dosing events. Participants who had incomplete data due to early discontinuation were not analyzed.|||nanograms*hours/milliliter (hr*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2654786|NCT01632566|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of Simvastatin||Predose up to 48 hours post dose at Day -3 and Day 28|Participants dosed with 75 mg LY3031207 from Days 1 through 28 and with oral administration of 10 mg open-label simvastatin on Days -3 and 28 and who had complete pharmacokinetic profiles following both simvastatin dosing events. Participants who had incomplete data due to early discontinuation were not analyzed.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2654787|NCT01632566|Secondary|Pharmacokinetics: Time of Maximum Concentration (Tmax) of LY3031207|Time of maximum concentration (Tmax) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.|Predose up to 48 hours post last dose at Day 28|Participants who received at least one dose of LY3031207 with evaluable Tmax data at Day 28. Participants who had incomplete data due to early discontinuation were not analyzed.|||hours||Full Range|Geometric Mean
2654788|NCT01632566|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3031207|Area under the concentration versus time curve in a dosing interval (AUC[0-tau]) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.|Predose up to 48 hours post last dose at Day 28|Participants who received at least one dose of LY3031207 with evaluable AUC (0-tau) data at Day 28. Participants who had incomplete data due to early discontinuation were not analyzed.|||nanograms*hours/milliliter (hr*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2654789|NCT01632566|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY3031207|Maximum concentration (Cmax) of LY3031207 post-repeated once daily doses at Day 28. Day 28 results were not calculated for participants who received 225 mg LY3031207 because the study was terminated prior to participants reaching 28 days of dosing for this treatment arm.|Predose up to 48 hours post last dose at Day 28|Participants who received at least one dose of LY3031207 with evaluable Cmax data at Day 28. Participants who had incomplete data due to early discontinuation were not analyzed.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2654790|NCT01632566|Primary|Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs|"A treatment emergent adverse event (TEAE) is defined as an adverse event (AE) that occurs postdose or that is present predose and becomes more severe postdose. AEs presented are of all causalities and all severities.~A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module."|Baseline to study completion (treatment completion and follow-up, up to 35 weeks)|Participants who received at least one dose of study drug.|||Participants|||Count of Participants
2654791|NCT01632423|Secondary|Patients Who Will Continue Use of Lumigan® After 14 Weeks|Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No.|14 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
2654792|NCT01632423|Secondary|Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks|Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No.|14 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
2654793|NCT01632423|Secondary|Physician Assessment of Tolerability Using a 4-Point Scale|Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|14 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
2654794|NCT01632423|Secondary|Patient Assessment of Tolerability Using a 4-Point Scale|Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|14 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
2654795|NCT01632423|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.|Baseline, 14 Weeks|All enrolled patients with complete data for this outcome measure|||Millimeters of Mercury (mmHg)||Inter-Quartile Range|Median
2654796|NCT01632345|Secondary|Percentage of Participants With At Least 1 AE in Weeks 0-96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|A secondary outcome in Part I/II combined was the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 96 weeks of treatment. The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-96.|Up to Week 96|The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.|||Percentage of participants||95% Confidence Interval|Number
2654797|NCT01632345|Secondary|Percentage of Participants With At Least 1 AE in Weeks 0-48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|A secondary outcome in Part I/II combined was the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 48 weeks of treatment. The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-48.|Up to Week 48|The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.|||Percentage of participants||95% Confidence Interval|Number
2654822|NCT01632280|Primary|Weight Change|Participants will be weighed at the indicated time points. Weight loss at 12 months will be the primary outcome of the study.|Baseline, 2 weeks after surgery, 10 days of tDCS, 1 month, 3 months, 6 months and 12 months follow up|1 Participant withdrew prior to obtaining outcome data at the 10th day of tDCS, 1 participant was lost to follow-up prior to the 3-month follow-up visit, and 1 participants were lost to follow-up prior to obtaining outcome data at the 6-month follow-up visit.|||pounds (lbs)||Standard Deviation|Mean
2654798|NCT01632345|Secondary|Change From Baseline in CD4 Cell Count at Week 96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|A secondary endpoint in Part I/II combined was the change from baseline in the CD4 count at Week 96 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for subjects who discontinued assigned treatment due to lack of efficacy.|Baseline, Week 96|The analyzed population consisted of all randomized subjects who had baseline data, received at least 1 dose of blinded study medication in either Part I or Part II, and had at least 1 post-randomization observation for the analysis of CD4 cell count at 96 weeks of study treatment.|||cells/mm^3||95% Confidence Interval|Mean
2654799|NCT01632345|Secondary|Change From Baseline in CD4 Cell Count at Week 48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the change from baseline in the CD4 count at Week 48 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for subjects who discontinued assigned treatment due to lack of efficacy.|Baseline, Week 48|The analyzed population consisted of all randomized subjects who had baseline data, received at least 1 dose of blinded study medication in either Part I or Part II, and had at least 1 post-randomization observation for the analysis of CD4 cell count at 48 weeks of study treatment.|||cells/mm^3||95% Confidence Interval|Mean
2654800|NCT01632345|Secondary|Change From Baseline in CD4 Cell Count at Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the change from baseline in the CD4 cell count at Week 24 in participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg. The OF approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for participants who discontinued assigned treatment due to lack of efficacy.|Baseline, Week 24|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of CD4 cell count at 24 weeks of study treatment.|||cells/mm^3||95% Confidence Interval|Mean
2654801|NCT01632345|Secondary|Change From Baseline in CD4 T Lymphocyte Cell Count at Week 24: Doravirine (All Doses) vs Efavirenz (Part I)|Evaluation of the change from baseline in the CD4 cell count at Week 24 in participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, and 200 mg), compared with participants receiving efavirenz 600 mg. The Observed Failure (OF) approach was used to handle missing data, and the Baseline CD4 cell count was carried forward for participants who discontinued assigned treatment due to lack of efficacy.|Baseline, Week 24|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in Part I, and had at least one post-randomization observation for the analysis of CD4 cell count at 24 weeks of study treatment.|||cells/mm^3||95% Confidence Interval|Mean
2654802|NCT01632345|Secondary|Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 96. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-96. The Non-Completer = Failure (NC=F) approach, in which participants who prematurely discontinued assigned treatment for any reason and were considered as failures thereafter, was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <200 copies/mL in Part I & Part II combined.|Week 96|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<200 copies/mL) at 96 weeks of study treatment.|||Percentage of participants||95% Confidence Interval|Number
2654803|NCT01632345|Secondary|Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Evaluation of the antiretroviral activity of doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA for 24 weeks, as measured by the percentage of participants with HIV-1 RNA <200 copies/mL at Week 48. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. This primary outcome was analyzed for RNA <200 copies/mL in Part I & Part II combined.|Week 48|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV RNA (<200 copies/mL) at 48 weeks of study treatment.|||Percentage of participants||95% Confidence Interval|Number
2654804|NCT01632345|Secondary|Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data for this analysis of efficacy. This secondary outcome was analyzed for HIV-1 RNA <200 copies/mL in Part I & Part II combined.|Week 24|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<200 copies/mL) at 24 weeks of study treatment.|||Percentage of participants||95% Confidence Interval|Number
2654805|NCT01632345|Secondary|Percentage of Participants With Virologic Response (HIV-1 RNA <200 Copies/mL) at Week 24: Doravirine (All Doses) vs Efavirenz (Part I)|Assessment of the virologic response to doravirine at all studied doses (25 mg, 50 mg, 100 mg, and 200 mg), compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <200 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay.The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The NC=F approach was used as the primary approach to handle missing data for this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <200 copies/mL in Part I.|Week 24|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in Part I, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<200 copies/mL) at 24 weeks of study treatment.|||Percentage of participants||95% Confidence Interval|Number
2654806|NCT01632345|Secondary|Percentage of Participants With Virologic Response (HIV-1 RNA <40 Copies/mL) at Week 96: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA <40 copies/mL at Week 96. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I & Part II combined.|Week 96|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<40 copies/mL) at 96 weeks of study treatment.|||Percentage of participants||95% Confidence Interval|Number
2654807|NCT01632345|Secondary|Percentage of Participants With Virologic Response (HIV-1 RNA <40 Copies/mL) at Week 48: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA <40 copies/mL at Week 48. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay. The percentage of participants in any treatment group with a virologic response was primarily assessed for Weeks 0-24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I & Part II combined.|Week 48|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<40 copies/mL) at 48 weeks of study treatment.|||Percentage of participants||95% Confidence Interval|Number
2654808|NCT01632345|Primary|Percentage of Participants With Virologic Response (HIV-1 RNA <40 Copies/mL) at Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the virologic response to doravirine at 100 mg, compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with HIV-1 RNA <40 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification of 40 copies/mL. The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The NC=F approach was used as the primary approach to handle missing data this analysis of efficacy. This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I & Part II combined.|Week 24|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in either Part I or Part II, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<40 copies/mL) at 24 weeks of study treatment.|||Percentage of participants||95% Confidence Interval|Number
2654809|NCT01632345|Primary|Percentage of Participants With Virologic Response (HIV-1 RNA) < 40 Copies/mL) at Week 24: Doravirine (All Doses) vs Efavirenz (Part I)|Assessment of the virologic response to doravirine at all studied doses (25 mg, 50 mg, 100 mg, and 200 mg), compared to efavirenz, each in combination with TRUVADA, as measured by the percentage of participants with plasma HIV-1 RNA <40 copies/mL at Week 24. HIV RNA levels were determined using the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification of 40 copies/mL. The percentage of participants in any treatment group with a virologic response was assessed at Week 24. The Non-Completer = Failure (NC=F) approach, in which participants who prematurely discontinued assigned treatment for any reason and were considered as failures thereafter, was used as the primary approach to handle missing data this analysis of efficacy.This primary outcome was analyzed for HIV-1 RNA <40 copies/mL in Part I.|Week 24|The analyzed population consisted of all randomized participants who received at least one dose of blinded study treatment in Part I, and had at least one post-randomization observation for the analysis of HIV-1 RNA (<40 copies/mL) at 24 weeks of study treatment.|||Percentage of participants||95% Confidence Interval|Number
2654810|NCT01632345|Primary|Percentage of Participants With CNS Events by Week 24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had CNS events over 24 weeks of treatment. CNS events were pooled and evaluated as pre-specified by the protocol (depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, hallucination auditory, hallucination visual, completed suicide, suicidal behavior, major depression, depressed mood, depressive symptom, insomnia, disturbance in attention, somnolence, dizziness, or concentration impaired). The percentage of participants in either treatment group with CNS events was assessed over Weeks 0-24.|Up to Week 24|The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.|||Percentage of participants||95% Confidence Interval|Number
2654811|NCT01632345|Primary|Percentage of Participants With CNS Events by Week 8: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had CNS events over 8 weeks of treatment. CNS events were pooled and evaluated as pre-specified by the protocol (depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, hallucination auditory, hallucination visual, completed suicide, suicidal behavior, major depression, depressed mood, depressive symptom, insomnia, disturbance in attention, somnolence, dizziness, or concentration impaired). The percentage of participants in either treatment group with CNS events was assessed over Weeks 0-8.|Up to Week 8|The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.|||Percentage of participants||95% Confidence Interval|Number
2654823|NCT01632267|Secondary|Number of Disability Claims|Number of disabiity claims during study window|During the one year study window (April 1, 2010 to April 1, 2011)|||||||
2654824|NCT01632267|Secondary|Number of Medical Absence Days|Number of medical absence days during study window|During the one year study window (April 1, 2010 to April 1, 2011)|||||||
2654825|NCT01632267|Primary|Number of Outpatient Visits|Number of outpatient healthcare visits during study window|During the one year study window (April 1, 2010 to April 1, 2011)||||units on a scale||Standard Deviation|Mean
2654812|NCT01632345|Primary|Percentage of Participants With At Least 1 AE in Weeks 0-24: Doravirine 100 mg vs Efavirenz (Part I & Part II Combined)|Assessment of the percentage of participants receiving doravirine at 100 mg, compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.The percentage of participants in any treatment group with at least 1 AE was assessed for Weeks 0-24.|Up to Week 24|The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in either Part I or Part II.|||Percentage of participants||95% Confidence Interval|Number
2654813|NCT01632345|Primary|Percentage of Participants Who Discontinued Study Therapy Due to AEs in Weeks 0-24: Doravirine (All Doses) vs Efavirenz (Part I)|Assessment of the percentage of participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, or 200 mg), compared with participants receiving efavirenz 600 mg, who discontinued therapy due to an AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.The percentage of participants in any treatment group who discontinued therapy due to an AE was primarily assessed for Weeks 0-24.|Up to Week 24|The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in Part I.|||Percentage of participants||95% Confidence Interval|Number
2654814|NCT01632345|Primary|Percentage of Participants With At Least 1 AE in Weeks 0-24: Doravirine (All Doses) vs Efavirenz (Part I)|Assessment of the percentage of participants receiving doravirine at all doses (25 mg, 50 mg, 100 mg, or 200 mg), compared with participants receiving efavirenz 600 mg, who had at least 1 AE over 24 weeks of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.The percentage of participants in any treatment group with at least 1 AE was primarily assessed for Weeks 0-24.|Up to Week 24|The analyzed population consisted of all randomized participants who received at least 1 dose of study treatment in Part I.|||Percentage of participants||95% Confidence Interval|Number
2654815|NCT01632306|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]|"Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size [<10 millimeter (mm) short axis]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.~A CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart."|Baseline Up to 6 Months|All participants who received at least one dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
2654816|NCT01632306|Secondary|Progression Free Survival (PFS)|PFS was as the time from enrollment to the earliest documented evidence of disease progression or death,whatever comes first.|Baseline to Disease Progression Up to 18 Months|All participants who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2654817|NCT01632306|Secondary|Percentage of Participants Who Survived at 6 Months||Baseline to Date of Death to any cause Up to 6 Months|All participants who received at least one dose of study drug.|||Percentage of participants||90% Confidence Interval|Number
2654818|NCT01632306|Secondary|Overall Survival (OS)||Baseline to Date of Death Due to any Cause Up to 21 Months|All the participants that received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2654819|NCT01632306|Primary|Change From Baseline to 4 Hours Post-Treatment on Day 0 in Glycogen Synthase Phosphorylation|Change in the phosphorylation level of glycogen synthase, a glycogen synthase kinase-3 beta (GSK-3beta) inhibitor, from baseline to 4 hours post-treatment on day 0 using tumor tissue and blood specimens.|Baseline, 4 Hours Post-Treatment on Day 0|Zero participants analyzed. GSK3β phosphorylation levels were not determined, and the primary endpoint was not examined as there wasn't viable tumor tissue for analysis.||||||
2654820|NCT01632280|Secondary|Change From Baseline in Inhibitory Control Over Food as Measured by the Stop Signal Reaction Task|"Inhibitory control over food was measured with a Stop Signal Task that was modified with the presence of distractors of two types: images of food and neutral images (control). The Stop Signal Task is a computerized task that evaluates an individual's ability to interrupt a motor response after its initiation (Logan 1994). Subjects were asked to press a response key matching the direction of an arrow, but refrain from pressing when an auditory cue (stop signal) appeared (25% trials). The main outcome of the task is the Stop-Signal-Reaction-Time (SSRT), in milliseconds, which reflects how long it takes to inhibit a response when a stop signal appears. The SSRT is considered a laboratory measure of inhibitory control capacity. Shorter SSRT reflects more efficient inhibitory control. Here a reduction of SSRT from baseline to 12 months indicates improvement in inhibitory capacity. We provide SSRT changes for food and neutral images, reflecting specific and general effects, respectively."|12 month follow-up vs. Baseline|1 participant withdrew prior to the 12 month follow-up and 2 participants were lost to follow-up prior to the 12 month follow-up.|||milliseconds (ms)||Standard Deviation|Mean
2654821|NCT01632280|Secondary|Eating Disinhibition as Measured by the Three Factor Eating Questionnaire (TFEQ)|Eating Disinhibition is an eating behavior trait that reflects a tendency towards overeating and eating opportunistically in an obesogenic environment. Examples include eating in response to negative affect, overeating when others are eating, not being able to resist temptations to eat, and overeating in response to the palatability of food (Bryant, King and Blundell. Obes Rev. 2008;9:409-19). Eating disinhibition was measured using the Three Factor Eating Questionnaire (TFEQ), which contains 16 questions for this factor. Responses are scored 0 or 1 and summed, thus eating disinhibition score ranges from 0 to 16. Higher scores denote higher levels of eating disinhibition.|Baseline and 12 months follow up|1 participant withdrew prior to the 12 month follow-up and 2 participants were lost to follow-up prior to the 12 month follow-up.|||units on a scale||Standard Deviation|Mean
2655262|NCT01628107|Secondary|Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks||Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value.|||U/kg/week||Standard Deviation|Mean
2654826|NCT01632241|Secondary|Number of Participants With Worst Toxicity Grade of 3 or 4 for Urinalysis Parameters [DB Phase]|Urinalysis parameters assessed were urine protein and protein/creatinine. Urine samples were collected for the measurement of urinalysis parameters by dipstick method up to 52 Weeks. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life threatening according to DMID AE Severity Grading. Only those participants with worst toxicity grade of 3 or 4 for urinalysis parameters have been presented.|Up to 52 weeks|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2654827|NCT01632241|Secondary|Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [DB Phase]|Blood samples were collected for the assessment of liver function and other chemistry parameters up to 52 Weeks. The parameters assessed were ALT, AST, GGT, albumin, hyperglycemia and hypoglycemia. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life threatening according to DMID AE Severity Grading. Only those participants with worst toxicity Grade of 3 or 4 for other chemistry parameters have been presented.|Up to 52 weeks|Safety Population. Only those participants with data available at the specified data points were analyzed.|||Participants|||Count of Participants
2654828|NCT01632241|Secondary|Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [DB Phase]|Blood samples were collected for the assessment of hematology parameters up to 52 Weeks. The parameters assessed were APTT, hemoglobin, leukocytes, neutrophils, platelets and prothrombin time. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life threatening according to DMID AE Severity Grading. Number of participants with worst toxicity Grade of 3 or 4 for hematology parameters have been presented.|Up to 52 weeks|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2654829|NCT01632241|Secondary|Number of Participants With AEs Leading to Treatment Discontinuation [DB Phase]|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to treatment discontinuation have been presented.|Up to 52 Weeks|Safety Population|||Participants|||Count of Participants
2654830|NCT01632241|Secondary|Number of Participants With Severe AEs [DB Phase]|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with severe AEs have been presented.|Up to 52 Weeks|Safety Population|||Participants|||Count of Participants
2654831|NCT01632241|Secondary|Number of Participants With nSAEs and SAEs [DB Phase]|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Safety population was defined as all participants who were randomized and treated with at least one dose of study treatment. Number of participants who had common nSAEs (>=5%) and any SAEs are presented.|Up to 52 Weeks|Safety Population|||Participants|||Count of Participants
2654832|NCT01632241|Secondary|Percent of Participants Whose Average Prednisone Dose Had Been Reduced to <=7.5 mg/Day in Participants Receiving Greater Than 7.5 mg/Day at Pre-belimumab Baseline (at Week 28 of OL Phase)|Average daily prednisone dose was calculated taking into account all steroids taken intravenously, intramuscularly, subcutaneously, intradermally and orally for both SLE and non-SLE reasons. A responder was defined as a participant who decreased their daily prednisone dose to <=7.5 mg/day from an OL Baseline dose >7.5 mg/day. The OL Baseline was defined as the last available value prior to the initiation of treatment with belimumab. The average daily prednisone dose was the sum of all PDs over 7 consecutive days including OL Week 28 divided by 7. Only those participants with data available at the specified data points were analyzed.|OL Baseline and Week 28 of OL Phase (Week 80)|mITT OL Population. Only those participants with data available at the specified data points were analyzed.|||Percentage of participants|||Number
2654833|NCT01632241|Secondary|Percent of Participants Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Week 40 Through 52, in Participants Receiving Greater Than 7.5 mg/Day at Baseline [DB Phase]|Average (avg.) daily prednisone (PRED.) dose was calculated taking into account all steroids taken intravenously, intramuscularly, subcutaneously, intradermally and orally for both Systemic Lupus Erythema (SLE) and non-SLE reasons. A responder was defined as having a PRED. reduction [REDN.] by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52. Drop-outs and Treatment failures were imputed as having no REDN. in PRED. (if Baseline PRED. >7.5 mg/day). At Baseline, the avg. daily prednisone dose [PD] was the sum of all PDs over 7 consecutive days [excluding Day 0], divided (DIV.) by 7. For analysis, the avg. PD was the total PD during Weeks 40 through 52 DIV. by the number of days during Weeks 40 through 52. Analysis was performed using a logistic regression model with covariates treatment group, Baseline PD, Baseline SS-S2K score, (<=9 vs >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and region (US/Canada vs. Rest of World).|Baseline and Week 40 through Week 52|mITT Population. Only participants with Baseline prednisone dose >7.5 mg/day were included.|||Percentage of participants|||Number
2654834|NCT01632241|Secondary|Time to First Severe Flare (as Measured by the Modified SLE Flare Index) [OL Phase]|Time to first severe SLE flare is defined as the number of days from OL treatment start date until the participant met an event (event date - OL treatment start date +1). Analyses of severe SLE flare was performed on modified SS SLE flare index that excludes SF that were triggered only by an increase in SS score to >12. For participants who died, data were censored at date of death if no SF occurred before death. Only post first OL treatment SF were considered. Median and inter-Quartile range (25th and 75th percentile) have been presented.|Up to Week 24 of OL Phase (Week 76)|mITT OL Population|||Days||Inter-Quartile Range|Median
2654869|NCT01631825|Secondary|UPDRS Part 4 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 4 sum score.~UPDRS sub-scale Part 4 assesses 11 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score.~A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2654835|NCT01632241|Secondary|Time to First Severe Flare (as Measured by the Modified SLE Flare Index) up to 52 Weeks [DB Phase]|Time to first severe SLE flare is defined as the number of days from treatment start date until the participant met an event (event date - treatment start date +1). Analyses of severe SLE flare was performed on modified SS SLE flare index that excludes severe flares (SF) that were triggered only by an increase in SS score to >12 (this may only represent a modest increase in disease activity). Treatment failures were imputed as SF. For participants who died, data were censored at date of death if no SF occurred before death. Only post-Baseline SF were considered. Analysis was performed using Cox proportional hazards model for the comparison between belimumab and placebo adjusting for Baseline SS-S2K score (<=9 vs. >=10), baseline complement levels (at least 1 C3/C4 low vs. no C3/C4 low), and region (US/Canada vs. Rest of World). Median and inter-Quartile range (1st and 3rd Quartiles) have been presented.|Up to 52 Weeks|mITT Population|||Days||Inter-Quartile Range|Median
2654836|NCT01632241|Secondary|Percentage of Participants Achieving SRI-SS Response Rate With the SELENA SLEDAI for Scoring of Proteinuria at Week 24 of OL Phase|SRI response is defined as >=4 point reduction, from OL Baseline in SS scoring for PU, no worsening (increase of <0.30 points from OL Baseline) in PGA and no new BILAG A ODS or 2 new BILAG B ODS compared with OL Baseline. For participants switching from placebo to belimumab 10 mg/kg IV in the open-label phase, Baseline was defined as the last assessment at the end of the double-blind phase (i.e. Week 52) pre-OL treatment. For participants that received belimumab 10 mg/kg IV during the double-blind phase and continued to receive belimumab 10 mg/kg IV during the open-label phase, Baseline was defined as Day 1 of the double-blind phase.|Week 24 of OL phase (Week 76)|mITT OL Population. Only those participants with data available at the specified data points were analyzed.|||Percentage of participants|||Number
2654837|NCT01632241|Secondary|Percentage of Participants Achieving SRI-SS Response Rate at Week 52 [DB Phase]|SRI is defined as >=4 point reduction, from Baseline in SS score, no worsening (increase of <0.30 points from Baseline) in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Drop-outs and Treatment failures were set to non-responders. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SS score (<=9 vs. >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and region (US/Canada vs. Rest of World).|Week 52|mITT Population. One participant in the mITT population Belimumab 10 mg/kg arm did not have a screening or Baseline PGA assessment; therefore, this participant did not contribute to the SRI/component analysis.|||Percentage of participants|||Number
2654838|NCT01632241|Primary|Number of Participants With Worst Toxicity Grade of 3 or 4 of Immunoglobulins [OL Phase]|Serum samples were obtained for the measurement of immunoglobulin G. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life threatening (Grade 4) according to DMID AE Severity Grading. Number of participants with worst toxicity grade of 3 or 4 of immunoglobulin G have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).|Week 52 to Week 84|ITT OL Population. Only those participants with data available at the specified data points were analyzed.|||Participants|||Count of Participants
2654839|NCT01632241|Primary|Number of Participants With Worst Toxicity Grade of 3 or 4 for Urinalysis Parameters [OL Phase]|Urinalysis parameters assessed were urine protein and protein/creatinine. Urine samples were collected for the measurement of urinalysis parameters by dipstick method. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life-threatening (Grade 4) according to DMID AE Severity Grading. Number of participants with worst toxicity grade of 3 or 4 for urinalysis parameters have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).|Week 52 to Week 84|ITT OL Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2654840|NCT01632241|Primary|Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase]|Blood samples were collected for the assessment of liver function and other chemistry parameters. The parameters assessed were alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), bilirubin, albumin, creatinine, hyperglycemia, hypoglycemia and urate. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life-threatening (Grade 4) according to DMID AE Severity Grading. Number of participants with worst toxicity Grade of 3 or 4 for liver function and other chemistry parameters have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).|Week 52 to Week 84|ITT OL Population. Only those participants with data available at the specified data points were analyzed.|||Participants|||Count of Participants
2654841|NCT01632241|Primary|Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [OL Phase]|Blood samples were collected for the assessment of hematology parameters. The parameters assessed were activated partial thromboplastin time (APTT), hemoglobin, leukocytes, neutrophils, platelets and prothrombin time. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life-threatening (Grade 4) according to Division of Microbiology and Infectious Diseases (DMID [Modified from DMID Adult Toxicity Tables, 2001]) AE Severity Grading. Number of participants with worst toxicity Grade 3 or 4 for hematology parameters have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).|Week 52 to Week 84|ITT OL Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|||Participants|||Count of Participants
2654842|NCT01632241|Primary|Number of Participants With AEs Leading to Treatment Discontinuation [OL Phase]|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to treatment discontinuation have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).|Week 52 to Week 84|ITT OL Population|||Participants|||Count of Participants
2654870|NCT01631825|Secondary|UPDRS Part 2 Sum Score (Off State)|Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state). A decrease in the scores means improvement.|Baseline, up to 54 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2654843|NCT01632241|Primary|Number of Participants With Severe AEs [OL Phase]|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with severe AEs have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).|Week 52 to Week 84|ITT OL Population|||Participants|||Count of Participants
2654844|NCT01632241|Primary|Number of Participants With Non-serious Adverse Events (nSAEs) and Serious Adverse Event (SAEs) [OL Phase]|An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Number of participants who had common nSAEs (>=5%) and any SAEs are presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).|Week 52 to Week 84|Intent-to-Treat (ITT) OL Population comprised of all randomized participants who received atleast one dose of open label treatment.|||Participants|||Count of Participants
2654845|NCT01632241|Primary|Percentage of Participants Achieving a SRI Response Rate With the Modified SLEDAI-2K Scoring for Proteinuria at Week 24 of OL Phase|SRI response is defined as >=4 point reduction, from OL Baseline in SS score (with the modified SLEDAI-2K scoring for PU), no worsening (increase of <0.30 points from OL Baseline) in PGA and no new BILAG A ODS or 2 new BILAG B ODS compared with OL Baseline. For participants switching from placebo to belimumab 10 mg/kg IV in the OL phase, Baseline was defined as the last assessment at the end of the double-blind phase (i.e. Week 52) pre-OL treatment. For participants that received belimumab 10 mg/kg IV during the double-blind phase and continued to receive belimumab 10 mg/kg IV during the OL phase, Baseline was defined as Day 1 of the double-blind phase.|Week 24 of OL phase (Week 76)|mITT OL population comprised of Intent-to-Treat (ITT) OL population (all randomized participants who received at least one dose of OL treatment) excluding participants who had any assessment at 3 sites (202196, 202513 or 107286). Only those participants with data available at the specified data points were analyzed.|||Percentage of participants|||Number
2654846|NCT01632241|Primary|Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index (SRI) Response Rate With the Modified Systemic Lupus Erythematosus Disease Activity Index- 2K (SLEDAI-2K) Scoring for Proteinuria at Week 52 [DB Phase]|SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in Lupus National Assessment(SELENA)SLEDAI[SS] score (with modified SLEDAI-2K scoring for proteinuria [PU]), no worsening (increase of <0.30 points from Baseline) in Physician's Global Assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics(BILAG)A organ domain score [ODS] or 2 new BILAG B ODS compared with Baseline. Drop-outs and treatment failures were set to non-responders. Analysis performed using a logistic regression model for comparison between belimumab and placebo with covariates treatment group, Baseline SS score (with modified SLEDAI-2K scoring for PU) (<=9 versus [vs.] >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and region (United States [US]/Canada vs. Rest of World). The Modified Intention-To-Treat (mITT) population comprised of safety population excluding participants who had any assessment at 3 sites (202196, 202513 or 107286).|Week 52|mITT Population. One participant in the mITT population Belimumab 10 mg/kg arm did not have a screening or Baseline PGA assessment; therefore, this participant did not contribute to the SRI/component analysis.|||Percentage of participants|||Number
2654847|NCT01632215|Secondary|Chronic Pain|"Numerical score from 0 to 10 scale:~Minimum value= zero (means no pain) and Maximum value= 10 (more intense pain)"|6 months||||points||Standard Deviation|Mean
2654848|NCT01632215|Primary|Pain Intensity|Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain|6 months||||units on a scale||Standard Deviation|Mean
2654849|NCT01632150|Secondary|Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event|Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator.|From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated|All participants who received thalidomide + elotuzumab + dexamethasone regimen, from first dose of study drug until discontinuation or until cyclophosphamide was initiated, whichever came first.|||Percentage of participants||95% Confidence Interval|Number
2654850|NCT01632150|Primary|Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated|All participants who received thalidomide + elotuzumab + dexamethasone regimen, from first dose of study drug until discontinuation or until cyclophosphamide was initiated, whichever came first.|||Percentage of participants||90% Confidence Interval|Number
2654851|NCT01632150|Secondary|Percentage of All Participants Who Received Treatment Including Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event|Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator. Cyclophosphamide dose reduction, delay, interruption, or discontinuation was permitted in the event of toxicity.|From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment|All participants who received thalidomide, elotuzumab, and dexamethasone (40), including those who had cyclophosphamide added to the regimen (11).|||Percentage of participants||95% Confidence Interval|Number
2654852|NCT01632150|Primary|Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment|All participants who received thalidomide, elotuzumab, and dexamethasone (40) including those who had cyclophosphamide added to the regimen (11).|||Percentage of participants||90% Confidence Interval|Number
2654853|NCT01632020|Primary|Mucosal Apoptotic Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy||10-21 days|Data not collected due to inadequate subject accrual. Analysis not completed.||||||
2654854|NCT01632020|Primary|Proliferation Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy||10-21 days|Data not collected due to inadequate subject accrual. Analysis not completed.||||||
2654855|NCT01631929|Primary|Time to Achieve Patient Stabilization|"Time needed to achieve patient stabilization defined by:~Plasmatic glucose < 250 mg/dl~Blood pH > 7.3~Plasmatic bicarbonate > 15 mmol/L"|Participants were followed for the duration of ketoacidosis (an expected average of 12 hours)||||Hours||95% Confidence Interval|Mean
2654856|NCT01631864|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths|Adverse event monitoring was conducted throughout the study.|8 weeks|Safety Analysis Set (SAS): The SAS included all randomized participants who received at least one dose of study drug.|||Participants|||Number
2654857|NCT01631864|Secondary|Oxidative Metabolism|Oxidative metabolism was assessed by indirect calorimetry.|57 days|Pharmacodynamic Analysis Set (PDS): Only participants from the PDS, who had both baseline and day 56 values, were included in the analysis. The PDS included all randomized participants who received at least one dose of study drug and had no protocol deviations with relevant impact on PD data.|||carbon dioxide to oxygen ratio||95% Confidence Interval|Least Squares Mean
2654858|NCT01631864|Secondary|Local Adipose Tissue Lipolysis, Glycerol Concentrations|Lipolysis was assessed through subcutaneous adipose tissue microdialysis. The actual measure type is adjusted geometric mean.|57 days|Pharmacodynamic Analysis Set (PDS): Only participants from the PDS, who had both baseline and day 56 values, were included in the analysis. The PDS included all randomized participants who received at least one dose of study drug and had no protocol deviations with relevant impact on PD data.|||micro mol/L||95% Confidence Interval|Geometric Mean
2654859|NCT01631864|Primary|Change From Baseline in Insulin Sensitivity Index|The insulin sensitivity index was assessed by hyperinsulinemic euglycemic clamp (HEGC). A positive change from baseline indicates improvement.|baseline, 8 weeks|Pharmacodynamic Analysis Set (PDS): Only participants from the PDS, who had both baseline and day 56 values, were included in the analysis. The PDS included all randomized participants who received at least one dose of study drug and had no protocol deviations with relevant impact on PD data.|||ug/kg*min/(mmol/L*pmol/L)||95% Confidence Interval|Mean
2654860|NCT01631825|Secondary|Each Item of UPDRS Part 4|The percentage of subjects with elevated scores for each item of UPDRS Part 4. The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF|||Percentage of Participants|||Number
2654861|NCT01631825|Secondary|Each Item of UPDRS Part 3 (on State)|The percentage of subjects with elevated scores for each item of UPDRS Part 3 (on state). The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF|||Percentage of Participants|||Number
2654862|NCT01631825|Secondary|Total of UPDRS Part 2 Sum Score (Average of on State and Off State) and UPDRS Part 3 Sum Score (on State)|"Mean change (LOCF) from baseline in total of UPDRS Part 2 sum score (average of on state and off state) and UPDRS Part 3 sum score (on state).~A decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2654863|NCT01631825|Secondary|Each Item of UPDRS Part 2 (Average of on State and Off State)|The percentage of subjects with elevated scores for each item of UPDRS Part 2 (average of on state and off state). The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF|||Percentage of Participants|||Number
2654864|NCT01631825|Secondary|Each Item of UPDRS Part 2 (Off State)|The percentage of subjects with elevated scores for each item of UPDRS Part 2 (off state). The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF|||Percentage of Participants|||Number
2654865|NCT01631825|Secondary|Each Item of UPDRS Part 2 (on State)|The percentage of subjects with elevated scores for each item of UPDRS Part 2 (on state). The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF|||Percentage of Participants|||Number
2654866|NCT01631825|Secondary|Each Item of UPDRS Part 1|The percentage of subjects with elevated scores for each item of UPDRS Part 1. The data at week 52 is shown.|Baseline, up to 54 weeks after dosing.|FAS, LOCF|||Percentage of Participants|||Number
2654867|NCT01631825|Secondary|The Modified Hoehn & Yahr Severity of Illness|"Change (LOCF) from baseline in the Modified Hoehn & Yahr Severity of Illness. The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease without impairment of balance; 2.5, Mild bilateral disease with recovery on pull test; 3, Mild to moderate bilateral disease, some postural instability, physically independent 4, Severe disability, still able to walk or stand unassisted; and 5, Wheelchair bound or bedridden unless aided.~The data at week 52 is shown."|Baseline, up to 54 weeks after dosing.|FAS, LOCF|||Percentage of participants|||Number
2654868|NCT01631825|Secondary|Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average of on State and Off State), UPDRS Part 3 Sum Score (on State), and UPDRS Part 4 Sum Score|"Mean change (LOCF) from baseline in total of UPDRS Part 1 sum score, UPDRS Part 2 sum score (average of on state and off state), UPDRS Part 3 sum score (on state), and UPDRS Part 4 sum score.~A decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2654871|NCT01631825|Secondary|UPDRS Part 2 Sum Score (On State)|Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state). A decrease in the scores means improvement.|Baseline, up to 54 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2654872|NCT01631825|Secondary|UPDRS Part 1 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 1 sum score.~UPDRS sub-scale Part 1 assesses 4 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2654873|NCT01631825|Secondary|"Absolute Time Spent Off"|"Mean number of hours in off state during a 24-hour period."|Baseline, up to 54 weeks after dosing|FAS subjects with measurable off time at baseline, LOCF|||Hours||Standard Deviation|Mean
2654874|NCT01631825|Secondary|UPDRS Part 2 Sum Score (Average of on State and Off State)|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average of on state and off state).~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, up to 54 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2654875|NCT01631825|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state).~UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, Up to 54 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
2654876|NCT01631825|Primary|Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters|"The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of AEs, vital signs, and laboratory parameters.~AEs of special interest (1-3) are defined as below:~sudden onset of sleep~obsessive-compulsive disorder or impulse-control disorder~hallucination, delusion~Application site reaction is scored as -, ±, +, ++, +++, or ++++. More + indicates a greater severity of symptoms. The worst score obtained throughout the evaluation period was to be assessed."|Up to 55 weeks after dosing|Safety set (SS)|||participants|||Number
2654877|NCT01631812|Primary|Skin Irritation Score of the Application Site|"Skin irritation score of the application site were evaluated according to the criteria below. The worst score throughout the treatment period was used in the analysis.~-: no reaction, ±: mild erythema, +: erythema, ++: erythema and Oedema, +++: erythema and oedema and rash papular, or serous papule, or vesicles, ++++: bullosum"|Up to 55 weeks after dosing|SS|||participants|||Number
2654878|NCT01631812|Secondary|"Absolute Time Spent Off"|"Mean number of hours in off state during a 24-hour period."|Up to 54 weeks after dosing|FAS subjects with “off state” at baseline|||Hours||Standard Deviation|Mean
2654879|NCT01631812|Secondary|UPDRS Part 2 Sum Score|Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) up to 54 weeks after dosing UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.|Baseline, Up to 54 weeks after dosing||||Scores on a scale||Standard Deviation|Mean
2654880|NCT01631812|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score|Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) up to 54 weeks after dosing UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.|Baseline, Up to 54 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
2654881|NCT01631812|Primary|Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters.|"Incidence and severity of adverse events, vital signs, and laboratory parameters after dosing.~*decrease in difference between supine and standing systolic blood pressure"|Up to 55 weeks after dosing|Safety set (SS)|||participants|||Number
2654882|NCT01631747|Secondary|Infant Length|Infant body measurement|1 year|Participants with one year infant body measures|||cm||Standard Deviation|Mean
2654883|NCT01631747|Secondary|Infant Weight|Infant Body measurements|1 year|Participants with measured or reported 1 year infant weight|||kg||Standard Deviation|Mean
2654884|NCT01631747|Secondary|Neonate Percent Body Fat|Neonate percent body fat as measured by PeaPod, and air displacement plethysmography system.|Delivery|Participants with PeaPod measurements|||percentage of weight||Standard Deviation|Mean
2654885|NCT01631747|Secondary|Head Circumference|Neonate birth measures|Delivery|Live births|||cm||Standard Deviation|Mean
2654886|NCT01631747|Secondary|Birth Length|Neonate birth measures|Delivery|participants with live births|||cm||Standard Deviation|Mean
2654887|NCT01631747|Secondary|Birth Weight|Neonatal Body measurements|Delivery|Participants with live births|||g||Standard Deviation|Mean
2654888|NCT01631747|Secondary|Insulin Resistance (IR)|"Insulin resistance will be measured with the assistance of a computer program (HOMA Calculator v2.2.3, Diabetic Trial Unit, University of Oxford) which uses blood Glucose and Insulin measures to yield the Homeostatic Model Assessment (HOMA) Insulin Resistance. HOMA IR (insulin resistance) is the reciprocal of insulin sensitivity (%S), as a percentage of a normal reference population (100/%S); Lower IR is better.~Note: estimates are model-derived, and not linear approximations."|Baseline (14 weeks) and 35 weeks|Participants with valid glucose levels.|||inverse proportion of normal reference||Inter-Quartile Range|Median
2654889|NCT01631747|Secondary|Insulin Sensitivity|Insulin resistance will be measured with the assistance of a computer program which will yield the Homeostatic Model Assessment (HOMA) Insulin Sensitivity (%S). 100% is equivalent to the normal reference, but needs to be interpreted in context of %B.|baseline(14 weeks) and 35-37 weeks|Participants with valid glucose measures|||percentage of normal reference||Inter-Quartile Range|Median
2655389|NCT01626690|Secondary|Intraoperative Blood Loss.|Intraoperative blood loss in mL's.|The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).||||mL||Standard Deviation|Mean
2654890|NCT01631747|Secondary|Steady State Beta Cell Function|Insulin resistance will be measured with the assistance of a computer program (HOMA Calculator v2.2.3, Diabetic Trial Unit, University of Oxford) which uses blood Glucose and Insulin measures to yield the Homeostatic Model Assessment (HOMA) Steady State beta cell function (%B). 100% is set at normal reference. Should not be interpreted alone, but in combination with Insulin Sensitivity (%S).|baseline (14 weeks) and 35-37 weeks|Participants with valid glucose measures|||percentage of normal reference||Inter-Quartile Range|Median
2654891|NCT01631747|Secondary|Leptin|Blood will be collected at Baseline and 35-37 weeks.|14-37 weeks|Participants with phlebotomy at week 35|||ug/L||Inter-Quartile Range|Median
2654892|NCT01631747|Secondary|Triglycerides|Blood will be collected at Baseline and 35-37 weeks.|14-37 Weeks|Participants with phlebotomy at 35 weeks|||mg/dL||Inter-Quartile Range|Median
2654893|NCT01631747|Secondary|Total Cholesterol|Blood will be collected at Baseline and 35-37 weeks.|14-37 Weeks|participants with Phlebotomy at week 35|||mg/dL||Inter-Quartile Range|Median
2654894|NCT01631747|Secondary|Low-density Lipoprotein (LDL)|Blood will be collected at Baseline and 35-37 weeks.|14-37 weeks|Participants with valid LDL measures|||mg/dL||Inter-Quartile Range|Median
2654895|NCT01631747|Secondary|High-density Lipoprotein (HDL)|Blood will be collected at Baseline and 35-37 weeks.|14-37 wks|Participants with phlebotomy|||mg/dL||Inter-Quartile Range|Median
2654896|NCT01631747|Secondary|Fasting Glucose|Blood will be collected at Baseline and 35-37 weeks.|14-37 wks|Participants with valid glucose measures|||mg/dL||Inter-Quartile Range|Median
2654897|NCT01631747|Secondary|Percentage of Participants With Gestational Diabetes|Oral Glucose Tolerance Test (OGTT) will be administered at 24-26wks, as part of routine obstetric visit. Difference in incidence of Gestational diabetes between study groups will be documented.|24-26 weeks|Inadequate testing was done for several participants.|||Participants|||Count of Participants
2654898|NCT01631747|Primary|Gestational Weight Gain (GWG)|The primary outcome is GWG as assessed continuously by the difference between the maternal weight measured at the baseline and at the 35-37 week visit.|14-37 weeks|Women who had at least one follow-up weight in addition to baseline clinic weight.|||kg||Standard Deviation|Mean
2654899|NCT01631682|Primary|Change From Baseline Skin Conductance Response|Skin conductance response (SCR) is the change in skin conductance level in response to a stimulus. We compared the SCR to a non-treated conditioned stimulus (CS+N) with the SCR to a treated conditioned stimulus (CS+R) by creating a difference score (CS+R - CS+N) for the day 3 data. Day 3 is 48 hours after the fear-conditioning procedure and serves as the primary measure of whether the treatment had an effect. SCR was measured in microSiemens; the SCR difference score reflects a change in microSiemens.|48hrs||||microSiemens||Standard Deviation|Mean
2654900|NCT01631656|Primary|IGA of Improvement|"Investigator's Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from 0 = Clear or No inflammatory signs of rosacea to 6 = Severe inflammatory signs of rosacea."|6 weeks||||units on a scale||Standard Deviation|Mean
2654901|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 31 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654902|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654903|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 24 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654904|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654905|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 17 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654970|NCT01631214|Secondary|Percentage of Participants With a Major Osteoporotic Fracture Through Month 12|Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded.|12 months|All randomized participants|||percentage of participants|||Number
2654906|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654907|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 10 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654908|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654909|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 3 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654910|NCT01631630|Secondary|Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period|Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654911|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 31 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654912|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654913|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 24 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654914|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654915|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 17 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2657197|NCT01607853|Secondary|Change From Baseline in Erythema at Day 8.|Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 8||||units on a scale||Standard Deviation|Mean
2654916|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654917|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 10 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654918|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654919|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 3 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654920|NCT01631630|Secondary|Depression Symptom Ratings Measured Bi-weekly During the Treatment Period|Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654921|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 31 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654922|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 28 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654923|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 24 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654924|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 21 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654971|NCT01631214|Secondary|Percentage of Participants With a Hip Fracture Through Month 12|Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.|12 months|All randomized participants|||percentage of participants|||Number
2654925|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 17 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654926|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 14 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654927|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 10 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654928|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 7 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654929|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 3 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654930|NCT01631630|Secondary|Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period|Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).|Day 1 of the treatment period|The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period|||Units on a scale||Standard Error|Least Squares Mean
2654931|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2654932|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2654933|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2654934|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2655045|NCT01630109|Secondary|Differences in Gastric Transit Time in Treatment vs. Placebo in Pill Capsule Studies|This study will investigate whether treatment with metoclopramide (5 mg or 10 mg) vs. placebo will affect gastric transit time.|12 hours||||minutes||Standard Deviation|Mean
2654935|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2654936|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2654937|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2654938|NCT01631630|Primary|Alcohol Craving in Response to the Stress Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2654939|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|6 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions|||Units on a scale||Standard Error|Least Squares Mean
2654940|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions|||Units on a scale||Standard Error|Least Squares Mean
2654941|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|4 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions|||Units on a scale||Standard Error|Least Squares Mean
2654942|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|3 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions|||Units on a scale||Standard Error|Least Squares Mean
2654943|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|2 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions|||Units on a scale||Standard Error|Least Squares Mean
2654944|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|1 hour after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions|||Units on a scale||Standard Error|Least Squares Mean
2654945|NCT01631630|Primary|Alcohol Craving in Response to the Lipopolysaccharide Challenge|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the subject receiving an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period|The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions|||Units on a scale||Standard Error|Least Squares Mean
2654946|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|90 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2654947|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|75 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2654948|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|60 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2654949|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|45 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2654950|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|30 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2654951|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2654952|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|5 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2654953|NCT01631630|Primary|Alcohol Craving in Response to the Alcohol Cue Script|Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).|15 minutes prior to the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period|The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)|||Units on a scale||Standard Error|Least Squares Mean
2654954|NCT01631435|Primary|Per-subject Diagnostic Yield of the PillCam Platform With the CD Capsule Within the Terminal Ileum and Colon as Compared to the Ileocolonoscopy Diagnostic Yield Within the Terminal Ileum and Colon|"the primary outcome will be evalluated as follow: The number of subjects having active Crohn's disease in their terminal ileum and / or colon as detected by the PillCam Platform with the CD capsule and ileocolonoscopy.~The analysis related to the primary endpoint was applied for the terminal ileum and colon only due to the limited access of ileocolonoscopy.~Each patient was classified as follows:~Active Crohn's disease is likely~Active Crohn's disease is NOT likely Active Crohn's disease included the followings lesions:~Aphthous ulceration~Ulcers (other than Aphthous)~Bleeding~Inflammatory stricture Lesions other than the above list were classified as Non active Crohn's disease."|All the end points and outcomes measures will be evaluated within 4 months from end of enrollment|subjects with symptoms associated with Crohn's disease|||number of subjects|||Number
2654955|NCT01631331|Secondary|Tumor Size Measurements Before and After Short Term Vismodegib Treatment|We measured the length and width of all tumors (target and non-target) before and after vismodegib treatment.|4 months (average)|6 of the 11 patients who completed the study had multiple BCCs. We followed 13 target BCCs and 30 non-target BCCs for potential tumor size change from these patients.|||percentage change in tumor size|basal cell carcinomas|95% Confidence Interval|Mean
2654956|NCT01631331|Secondary|Tumor Recurrence Rate of Treated BCCs|Recurrence rate of BCCs during a 22 month average (range 12 to 28 months) follow up period.|average of 22 months|11 patients completed the trial and 13 target BCCs were excised.|||BCCs|BCCs||Count of Units
2654957|NCT01631331|Secondary|Number of Tumors Demonstrating Histologic Cure|Determination of histologic cure (no residual BCC on the ﬁrst piece of excised tissue) post serial sectioning of parafﬁn embedded Mohs specimens|Average of 4 months|Patients each had 1 to 2 target BCCs identified at baseline for surgical excision and were treated with vismodegib for an average of 4 months. Only target lesions are included in this analysis.|||BCCs|BCCs||Count of Units
2654958|NCT01631331|Primary|Percent Change in Surgical Defect Area After the Treatment Period Using Calipers and Photographs Was Calculated|At baseline, we selected 1 to 2 tumors per patient for surgery (13 target tumors selected). At baseline,1 Mohs surgeon measured the estimated surgical defect area around the target tumor. For tumors to be excised by Mohs we defined estimated surgical defect as the tumor size plus a 2-mm circumferential margin, presuming tumor clearance after a Mohs stage-1 excision. For the tumor undergoing standard (non-Mohs) excision, we used tumor size plus a standard 4-mm margin11 for the estimated surgical defect. On the day of the surgery, we measured the surgical defect area as the final tumor-free defect after the Mohs procedure or non-Mohs excision immediately before closure. We used the Image J software program (National Institutes of Health, Bethesda, MD) to calculate tumor area (cm2). Only target tumors are included in this analysis.|average of 4 months|Only patients who were treated with vismodegib for an average of 4 months were included in our analysis. Only target tumors are included in this analysis.|||percentage size change from baseline|BCCs|95% Confidence Interval|Mean
2654959|NCT01631227|Primary|Assess the Therapeutic Equivalence of Eprosartan (a New Formulation Containing Only the Active Moiety Eprosartan) With Eprosartan Mesylate (Currently Marketed Formulation) on Change of Sitting Diastolic Blood Pressure (DBP) From Baseline|Change from baseline of diastolic blood pressure (DBP), sitting|8 weeks|Full analysis subject sample|||mmHg||Standard Deviation|Least Squares Mean
2654960|NCT01631214|Secondary|Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 36|Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and month 36|All randomized participants with a baseline and ≥ 1 post-baseline evaluation during the open-label period at or before month 36; Missing values were imputed by carrying forward the last non-missing post-baseline value in the open-label treatment period prior to the missing value.|||percent change||Standard Error|Least Squares Mean
2654961|NCT01631214|Secondary|Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 36|Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and month 36|All randomized participants with a baseline and ≥ 1 post-baseline evaluation during the open-label period at or before month 36; Missing values were imputed by carrying forward the last non-missing post-baseline value in the open-label treatment period prior to the missing value.|||percent change||Standard Error|Least Squares Mean
2654962|NCT01631214|Secondary|Percent Change From Baseline in Bone Mineral Density of the Lumbar Spine at Month 36|Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and month 36|All randomized participants with a baseline and ≥ 1 post-baseline evaluation during the open-label period at or before month 36; Missing values were imputed by carrying forward the last non-missing post-baseline value in the open-label treatment period prior to the missing value.|||percent change||Standard Error|Least Squares Mean
2654963|NCT01631214|Secondary|Percent Change From Baseline in Bone Mineral Density at the Femoral Neck at Month 12|Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and month 12|All randomized participants with a baseline and ≥ 1 post-baseline evaluation at or before month 12; Last observation carried forward imputation was used.|||percent change||Standard Error|Least Squares Mean
2654964|NCT01631214|Secondary|Percent Change From Baseline in Bone Mineral Density at the Total Hip at Month 12|Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and month 12|All randomized participants with a baseline and ≥ 1 post-baseline evaluation at or before month 12; Last observation carried forward imputation was used.|||percent change||Standard Error|Least Squares Mean
2654965|NCT01631214|Secondary|Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12|Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and month 12|All randomized participants with a baseline and ≥ 1 post-baseline evaluation at or before month 12; Last observation carried forward imputation was used.|||percent change||Standard Error|Least Squares Mean
2654966|NCT01631214|Secondary|Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at at Month 24|Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and month 24|All randomized participants with a baseline and ≥ 1 post-baseline evaluation during the open-label period at or before month 24; Missing values were imputed by carrying forward the last non-missing post-baseline value in the open-label treatment period prior to the missing value.|||percent change||Standard Error|Least Squares Mean
2654967|NCT01631214|Secondary|Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24|Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and month 24|All randomized participants with a baseline and ≥ 1 post-baseline evaluation during the open-label period at or before month 24; Missing values were imputed by carrying forward the last non-missing post-baseline value in the open-label treatment period prior to the missing value.|||percent change||Standard Error|Least Squares Mean
2654968|NCT01631214|Secondary|Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 24|Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and month 24|All randomized participants with a baseline and ≥ 1 post-baseline evaluation during the open-label period at or before month 24; Missing values were imputed by carrying forward the last non-missing post-baseline value in the open-label treatment period prior to the missing value.|||percent change||Standard Error|Least Squares Mean
2654969|NCT01631214|Secondary|Percentage of Participants With a Clinical Vertebral Fracture Through Month 12|A clinical vertebral fracture is a new or worsening vertebral fracture assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms of back pain indicative of a fracture, regardless of trauma severity or whether it is pathologic.|12 months|All randomized participants; Last observation carried forward imputation was used.|||percentage of participants|||Number
2655390|NCT01626690|Secondary|Incidence of Postoperative Shivering in Recovery Room.||The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).||||Number of patients reporting shivering|||Number
2654972|NCT01631214|Secondary|Percentage of Participants With a Nonvertebral Fracture Through Month 12|A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.|12 months|All randomized participants|||percentage of participants|||Number
2654973|NCT01631214|Secondary|Percentage of Participants With Any Fracture Through Month 12|All fractures include any osteoporotic nonvertebral fractures that are not associated with high trauma severity or pathologic fractures and new or worsening vertebral fractures regardless of trauma severity or pathologic fractures.|12 months|All randomized participants|||percentage of participants|||Number
2654974|NCT01631214|Secondary|Percentage of Participants With New Vertebral Fractures Through Month 12|"New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale:~Grade 0 (Normal) = no fracture;~Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);~Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;~Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.~Incident vertebral fractures were confirmed by a second independent reader."|12 months|Randomized participants with a baseline and ≥ 1 postbaseline evaluation of vertebral fracture, including participants who had vertebrae with missing Genant semiquantitative scores at baseline whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. Last observation carried forward imputation was used.|||percentage of participants|||Number
2654975|NCT01631214|Secondary|Percentage of Participants With a Clinical Fracture Through Month 12|Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.|12 months|All randomized participants; Missing values for clinical fractures were imputed using last observation carried forward.|||percentage of participants|||Number
2654976|NCT01631214|Secondary|Percentage of Participants With a Clinical Vertebral Fracture Through Month 24|A clinical vertebral fracture is a new or worsening vertebral fracture assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms of back pain indicative of a fracture, regardless of trauma severity or whether it is pathologic.|24 months|All randomized participants; Last observation carried forward imputation was used.|||percentage of participants|||Number
2654977|NCT01631214|Secondary|Percentage of Participants With a Hip Fracture Through Month 24|Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.|24 months|All randomized participants|||percentage of participants|||Number
2654978|NCT01631214|Secondary|Percentage of Participants With a Nonvertebral Fracture Through Month 24|A nonvertebral fracture was defined as a documented fracture excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.|24 months|All randomized participants|||percentage of participants|||Number
2654979|NCT01631214|Secondary|Percentage of Participants With a Clinical Fracture Through Month 24|Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.|24 months|All randomized participants; Missing values for clinical fractures were imputed using last observation carried forward.|||percentage of participants|||Number
2654980|NCT01631214|Secondary|Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24|A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4 according to the Genant Semiquantitative Scoring method. A participant had multiple new or worsening vertebral fractures when there were ≥ 2 vertebrae from T4 to L4 with ≥ 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit. Incident vertebral fractures were confirmed by a second independent reader.|24 months|Randomized participants with a baseline and ≥ 1 postbaseline evaluation of vertebral fracture, including participants who had vertebrae with missing Genant semiquantitative scores at baseline whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. Last observation carried forward imputation was used.|||percentage of participants|||Number
2654981|NCT01631214|Secondary|Percentage of Participants With a Hip Fracture at the Primary Analysis|Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.|The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).|All randomized participants|||percentage of participants|||Number
2654982|NCT01631214|Secondary|Percentage of Participants With a Major Nonvertebral Fracture at the Primary Analysis|Major nonvertebral fractures included a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip.|The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).|All randomized participants|||percentage of participants|||Number
2655448|NCT01625689|Secondary|Post Vaccination SIIL LAIV Virus Shedding/Vaccine-take Will be Parameterized by the Percentage of Participants With Detectable Virus by Post Vaccination Day.||2, 4, and 7 days post-vaccination|||||||
2654983|NCT01631214|Secondary|Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24|"A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4 according to the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale:~Grade 0 (Normal) = no fracture;~Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);~Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;~Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.~Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method."|24 months|Randomized participants with a baseline and ≥ 1 postbaseline evaluation of vertebral fracture, including participants who had vertebrae with missing Genant semiquantitative scores at baseline whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. Last observation carried forward imputation was used.|||percentage of participants|||Number
2654984|NCT01631214|Secondary|Percentage of Participants With Any Fracture at the Primary Analysis|All fractures include any osteoporotic nonvertebral fractures that are not associated with high trauma severity or pathologic fractures and new or worsening vertebral fractures regardless of trauma severity or pathologic fractures.|The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).|All randomized participants|||percentage of participants|||Number
2654985|NCT01631214|Secondary|Percentage of Participants With a Nonvertebral Fracture at the Primary Analysis|A nonvertebral fracture was defined as a documented fracture excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.|The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).|All randomized participants|||percentage of participants|||Number
2654986|NCT01631214|Primary|Percentage of Participants With a Clinical Fracture at the Primary Analysis|All fracture assessments were performed by blinded central imaging readers. Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.|The primary analysis was performed when clinical fracture events had been confirmed in at least 330 patients and all participants had completed the month 24 visit. The median follow-up was 2.7 years (interquartile range, 2.2 to 3.3).|All randomized participants. Missing values for clinical fractures were imputed using last observation carried forward.|||percentage of participants|||Number
2654987|NCT01631214|Primary|Percentage of Participants With New Vertebral Fractures Through Month 24|"All fracture assessments were performed by blinded central imaging readers.~New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant Semiquantitative Scoring method based on assessment of x-rays according to the following scale:~Grade 0 (Normal) = no fracture;~Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);~Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;~Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height.~Incident vertebral fractures were confirmed by a second independent reader using the Semiquantitative method."|24 months|Randomized participants with a baseline and ≥ 1 postbaseline evaluation of vertebral fracture, including participants who had vertebrae with missing Genant semiquantitative scores at baseline whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. Last observation carried forward imputation was used.|||percentage of participants|||Number
2654988|NCT01631149|Secondary|Nausea and Vomiting|"Using a yes - no questionnaire, the patients will be asked whether they are nauseated or not or whether they vomited. In fact yes indicates the nr of participants.~No statistical analysis was performed."|Measurements will be made during the stay in the operating room for an average period of 3 hours||||participants|||Number
2654989|NCT01631149|Secondary|Postoperative Sedation Score|"Using a 5-point sedation scale, sedation levels will be obtained throughout the postoperative period.~0 = wide awake 5= severely sedated, The sedation data were averaged over time."|Measurements will be made during the stay in the operating room for an average period of 3 hours||||units on a scale (0-5)||Standard Error|Mean
2654990|NCT01631149|Secondary|Post-operative Pain|"Using a 10 cm visual analogue score pain relief score will be measured. 0 = no pain 10 = most severe pain~No statistical analysis was performed!"|measurements are made in the recovery room following surgery for an average prior of 1 hour|The pain data were averaged over time and compared by t-test between groups|||units on a scale (0-10 cm)||Standard Deviation|Mean
2654991|NCT01631149|Secondary|Breathing|"In the recovery room the respiratory rate will be measured continuously using the Respir8 respiratory rate monitor. The data will be recorded on the CRF at 15 min intervals.~Breathing rate units are number of breaths as measured in 1 min.~Comparison by t-test: NS between treatments"|Measurements will be made during the stay in the recovery room for an average period of 3 hours|In each subject the scores over time were averaged and a comparison between treatments was performed using a t-test|||breaths per min||Standard Deviation|Mean
2654992|NCT01631149|Primary|Surgical Rating Scale|"During the procedure, the surgical condition will be scored by the surgeon using a 5-point surgical rating scale. In order to reduce variability in the surgical rating all surgeries will be performed by one single surgeon. The rating scale will be a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The surgeon will score the condition at 15 minute intervals. In case of a sudden change in surgical conditions additional scores will be added to the case record form. If conditions are poor (score 1 or 2), muscle relaxation will be increased, a score of 1 will be used.~In each subject the scores over time were averaged and a comparison between treatments was performed using a t-test"|Measurements will be made during the stay in the operating room for an average period of 3 hours|Each participant that was dosed was analyzed|||units on a scale (1-5)||Standard Deviation|Mean
2654993|NCT01631110|Primary|Geometric Mean Titer|"GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers|||GMT fold increase from baseline||95% Confidence Interval|Number
2654994|NCT01631110|Primary|Seroconversion|"Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers|||percentage of subjects||95% Confidence Interval|Number
2654995|NCT01631110|Secondary|Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability|"Solicited local and systemic AEs, Unsolicited AEs~Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).~Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4"|Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)|Safety population, all vaccinated subjects|||Participants|||Number
2654996|NCT01631110|Primary|Seroprotection|"Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers|||percentage of subjects||95% Confidence Interval|Number
2654997|NCT01631071|Primary|Geometric Mean Titer|"GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers|||GMT fold increase from baseline||95% Confidence Interval|Number
2654998|NCT01631071|Primary|Seroconversion|"Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers|||percentage of subjects||95% Confidence Interval|Number
2654999|NCT01631071|Secondary|Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability|"Solicited local and systemic AEs, Unsolicited AEs~Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).~Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4"|Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)||||participants|||Number
2655000|NCT01631071|Primary|Seroprotection|"Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|Day 22 +/- 2 days|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers|||percentage of subjects||95% Confidence Interval|Number
2655001|NCT01630811|Secondary|Change in Aggressive Behavior|Demonstrate a trend towards reduced aggressive behavior as measured by Overt Aggression Scale (OAS). It consists of a scale from 0 - 40, and a lower score can be interpreted as less frequent and/or less intense presentation of the undesirable behavior. Reported is the mean difference in scores from baseline to 8 weeks. A positive score indicates more aggressive behavior and a negative score indicates less aggressive behavior.|Baseline and 8 weeks|One subject withdrew at the time of crossover.|||units on a scale||Standard Deviation|Mean
2655002|NCT01630811|Primary|Primary Safety Endpoints|Number of serious adverse events|Week 0 through week 25||||Participants|||Count of Participants
2655003|NCT01630811|Primary|Change in Maladaptive Behaviors|Demonstrate a change in frequency and intensity of maladaptive behaviors as measured by the Aberrant Behavior Checklist (ABC) Irritability subscale in subjects given Nuedexta 8 weeks over subjects given placebo. This checklist consists of 20 questions relating to behavior and the reported total score is on a scale from 0 to 60. A lower score can be interpreted as less frequent and/or less intense presentation of the undesirable behavior. The below values are the difference in ABC scores from baseline to 8 weeks. A negative difference indicates improved behavior.|Baseline and 8 weeks|One subject withdrew at the time of crossover.|||units on a scale||Standard Deviation|Mean
2655004|NCT01630694|Secondary|Mean Tongue Volume|The midsagittal scans were used to measure the cross-sectional area of the tongue. Transverse scans obtained in the midsection of the tongue (at the glossal end of the genioglossus muscle) provided a measure of the tongue width, which was measured between the most distant points on its upper surface. The tongue volume was derived from the multiplication of the midsagittal cross-sectional area by the tongue width.|end of study approximately one year|only 6 patients in each group were analyzed because the remaining patients were not eligible for analysis based on a review of their electronic medical chart|||cubic centimeters||Standard Deviation|Mean
2655005|NCT01630694|Primary|Mean Hyomental Distance Ratio|A curved low-frequency transducer and a Flex focul 400 ultrasound system were used to visualize the tongue and shadows of the hyoid bone and mandible. Midsagittal and coronal/transverse scans from the ultrasound were analyzed using ImageJ. The hyomental distances in the neutral and heal-extended positions were measured from the upper border of the hyoid bone to the lower border of the mentum. The ratio is defined as the ratio of the hyomental distance at the extreme of head extension to that in the neutral position.|end of study approximately one year|only 6 patients in each group were analyzed because the remaining patients were not eligible for analysis based on a review of their electronic medical chart|||ratio||Standard Deviation|Mean
2655449|NCT01625689|Secondary|The Post-vaccination Anti-influenza Immunologic Response Will be Measured Based on the Type of Immunologic Assay and Categorized by Vaccine Virus Strain, Participant Baseline Serostatus, and Vaccine Allocation||Approximately 21 days post-vaccination|||||||
2655006|NCT01630616|Primary|Apparent Terminal t1/2 of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg|Apparent terminal t1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. The apparent terminal t1/2 data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg apparent terminal t1/2 data from study MK-0822-007. PK analysis was not performed on participants receiving placebo.|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 10 mg, who had available t1/2 data from at least one treatment including young adults from historical study MK-0822-007. PK parameters were not analyzed for the Placebo arms and data are presented for the Odanacatib 50 mg arms in other outcome measures.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2655007|NCT01630616|Primary|Tmax of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg|Tmax is the time required to reach Cmax. The Tmax data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg Tmax data from study MK-0822-007. PK analysis was not performed on participants receiving placebo.|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 10 mg, who had available Tmax data from at least one treatment including young adults from historical study MK-0822-007. PK parameters were not analyzed for the Placebo arms and data are presented for the Odanacatib 50 mg arms in other outcome measures.|||Hours||Full Range|Median
2655008|NCT01630616|Primary|Cmax of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given. The Cmax data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg Cmax data from study MK-0822-007. PK analysis was not performed on participants receiving placebo.|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 10 mg, who had available Cmax data from at least one treatment including young adults from historical study MK-0822-007. PK parameters were not analyzed for the Placebo arms and data are presented for the Odanacatib 50 mg arms in other outcome measures.|||nM||95% Confidence Interval|Geometric Mean
2655009|NCT01630616|Primary|AUC0-168 for Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg|Area Under the Plasma Concentration/Time Curve from Time 0 to Hour 168 (AUC0-168) is a measure of the total amount of drug in the plasma from the dose administration to the Hour 168 sample. The AUC0-168 data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg AUC0-168 data from study MK-0822-007. PK analysis was not performed on participants receiving placebo.|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, and 168 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 10 mg, who had available AUC0-168 data from at least one treatment including young adults from historical study MK-0822-007. PK parameters were not analyzed for the Placebo arms and data are presented for the Odanacatib 50 mg arms in other outcome measures.|||μM·hr||95% Confidence Interval|Geometric Mean
2655010|NCT01630616|Primary|AUC0-inf for Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg|Area Under the Plasma Concentration/Time Curve from Time 0 to infinity (AUC0-inf) is a measure of the total amount of drug in the plasma from the dose administration to the last measurable sample. The AUC0-inf data for 10 mg odanacatib in adolescents were compared with the historical young adult odanacatib 10 mg AUC0-inf data from study MK-0822-007. PK analysis was not performed on participants receiving placebo.|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 10 mg, who had available AUC0-inf data from at least one treatment including young adults from historical study MK-0822-007. PK parameters were not analyzed for the Placebo arms and data are presented for the Odanacatib 50 mg arms in other outcome measures.|||μM·hr||95% Confidence Interval|Geometric Mean
2655011|NCT01630616|Secondary|Change From Baseline in Urinary Aminoterminal Crosslinked Telopeptide of Type 1 Collagen (uNTx/Cr) at 168 Hours Postdose|Urinary aminoterminal crosslinked telopeptide of Type I collagen (uNTx/Cr) is a biochemical marker of bone resorption. Odanacatib selectively and potently inhibits cathepsin K (CatK), the primary catalyst of bone resorption. Since CatK is the enzyme responsible for bone matrix degradation it is possible to use bone resorption biomarkers to quantify pharmacodynamic effects in short term clinical studies. CatK cleaves the N-telopeptide of collagen type I to form NTx and also cleaves the serum C-terminal telopeptide of collagen type I (1-CTP - itself generated by the action of matrix metalloproteases) to generate CTx. Urine NTx measurements (in bone collagen equivalents [BCE]) have been normalized to creatinine clearance.|Baseline (predose Day 1) and 168 hours postdose|The population analyzed included all randomized, treated participants who had available uNTx/Cr data for Baseline and 168 hours.|||nmol[BCE]/mmol[creatinine])||Geometric Coefficient of Variation|Geometric Mean
2655012|NCT01630616|Primary|Apparent Terminal Half-life (t1/2) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg|T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%. PK analysis was not performed on participants receiving placebo.|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 50 mg, who had available t1/2 data from at least one treatment. PK parameters were not analyzed for the Placebo arms and data are presented for the Adolescents Odanacatib 10 mg arm in other outcome measures.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2655013|NCT01630616|Primary|Time to Cmax (Tmax) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg|Tmax is the time required to reach Cmax. PK analysis was not performed on participants receiving placebo.|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 50 mg, who had available Tmax data from at least one treatment. PK parameters were not analyzed for the Placebo arms and data are presented for the Adolescents Odanacatib 10 mg arm in other outcome measures.|||Hours||Full Range|Median
2655046|NCT01630109|Primary|Difference in Treatment vs. Placebo in Pill Capsule Completion Rates|This study is investigating whether there is a difference in pill capsule completion rates between a treatment group (metoclopramide) vs. placebo. It is also looking at differences in completion rates between two different doses of metoclopramide (5 mg vs. 10 mg).|12 hours||||percentage of complete capsule studies|||Number
2655014|NCT01630616|Primary|Maximum Plasma Concentration (Cmax) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg|"Cmax is a measure of the maximum amount of drug in the plasma after the drug dose is given. The Method of Dispersion is more accurately described as Percent Geometric Coefficient of Variation. PK analysis was not performed on participants receiving placebo."|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 50 mg, who had available Cmax data from at least one treatment. PK parameters were not analyzed for the Placebo arms and data are presented for the Adolescents Odanacatib 10 mg arm in other outcome measures.|||nM||Geometric Coefficient of Variation|Geometric Mean
2655015|NCT01630616|Primary|Area Under the Plasma-Drug Concentration Time Curve From Hour 0 to 168 Hours (AUC0-168) For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg|"Area Under the Plasma-Drug Concentration/Time Curve from Time 0 to Hour 168 (AUC0-168) is a measure of the total amount of drug in the plasma from the dose administration to the Hour 168 sample. The Method of Dispersion is more accurately described as Percent Geometric Coefficient of Variation. PK analysis was not performed on participants receiving placebo."|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, and 168 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 50 mg, who had available AUC0-168 data from at least one treatment. PK parameters were not analyzed for the Placebo arms and data are presented for the Adolescents Odanacatib 10 mg arm in other outcome measures.|||μM·hr||Geometric Coefficient of Variation|Geometric Mean
2655016|NCT01630616|Primary|Area Under the Plasma-Drug Concentration Time Curve From Hour 0 to Infinity (AUC0-inf) For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg|"Area Under the Plasma-Drug Concentration/Time Curve from Time 0 to infinity (AUC0-inf) is a measure of the total amount of drug in the plasma from the dose administration to the last measurable sample. The Method of Dispersion is more accurately described as Percent Geometric Coefficient of Variation. Pharmacokinetic (PK) analysis was not performed on participants receiving placebo."|Hour 0 (predose), and at 1, 2, 6, 8, 12, 24, 72, 96, 120, 168, 240, and 336 hours post-dose|The population analyzed included all randomized participants, treated with odanacatib 50 mg, who had available AUC0-inf data from at least one treatment. PK parameters were not analyzed for the Placebo arms and data are presented for the Adolescents Odanacatib 10 mg arm in other outcome measures.|||μM·hr||Geometric Coefficient of Variation|Geometric Mean
2655017|NCT01630616|Primary|Number of Participants Who Report an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Day 14|The population analyzed consisted of all randomized participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2655018|NCT01630200|Secondary|Change From Baseline in COPD Assessment Test at Month 6|COPD Assessment Test (CAT) will be assessed to quantify patients disease related symptoms and to measure the impact of COPD on a patient's life, and how this changes over time. CAT is a standardised and validated patient questionaire comprising 8 distinct questions about different COPD-related symptoms. Each symptom is quantified by the patient on a numeric scale ranging from 0 to 5. Each symptom gives a number of points quantified as interval data without decimal places. The 8 different numbers of points are added to a total number expressed as the final points of the CAT score. The minimum achievable number of points is 0 and the maximum achievable number of points is 40. Higher values provide high symptoms and worse outcome, lower values provide low symptoms and better outcome.|baseline, month 6||||units on a scale||95% Confidence Interval|Least Squares Mean
2655019|NCT01630200|Secondary|Change From Baseline in 6-Minute Walk Test at Month 6|6-Minute Walk Test (6MWT) will be assessed to quantify functional exercise capacity following the standardized protocol of the American Thoracic Society|baseline, month 6||||meters||95% Confidence Interval|Least Squares Mean
2655020|NCT01630200|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second at Month 6|Forced Expiratory Volume in 1 second (FEV1) will be measured via standardized Spirometry|baseline, month 6||||% predicted||95% Confidence Interval|Least Squares Mean
2655021|NCT01630200|Secondary|Change From Baseline in Tumor Necrosis Factor-alpha at Month 6|Circulating levels of Tumor Necrosis Factor-alpha (TNF-alpha) will be quantified from venous blood samples via Enzyme-linked Immunosorbent Assay|baseline, month 6||||pg/ml||95% Confidence Interval|Least Squares Mean
2655022|NCT01630200|Secondary|Change From Baseline in Asymmetric Dimethylarginine at Month 6|Circulating levels of Asymmetric dimethylarginine (ADMA) will be quantified from venous blood samples via Enzyme-linked Immunosorbent Assay|baseline, month 6||||µmol/l||95% Confidence Interval|Least Squares Mean
2655023|NCT01630200|Secondary|Change From Baseline in Matrix Metalloproteinase-9|Circulating levels of Matrix Metalloproteinase-9 (MMP-9) will be quantified from venous blood samples via Enzyme-linked Immunosorbent Assay|baseline, month 6||||ng/ml||95% Confidence Interval|Least Squares Mean
2655024|NCT01630200|Secondary|Change From Baseline in Augmentation Index at Month 6|The curve of the peripheral pressure wave will be recorded from the radial artery. Augmentation index (Aix) will be calculated from the generated central aortic pressure waveform via pulse wave analysis function. To correct for respective influences, Aix will be adjusted for a heart rate of 75 bpm. Appropriate intra observer validity will be assured via an operator index ≥ 80.|baseline, month 6||||Index||95% Confidence Interval|Least Squares Mean
2655025|NCT01630200|Secondary|Change From Baseline in Reactive Hyperemia Index at Month 6|Endothelial dysfunction will be assessed by Flow Mediated Dilation via the Endopat device. This validated system measures the pulse wave amplitudes at the tip of both index fingers. The dominant arm will be occluded for 5 minutes by a sphygmomanometric cuff. After cuff deflation the pulse wave amplitude will be assessed to finally calculate the ratio of pulse wave amplitude before and after cuff-induced hyperemia. The so called reactive hyperemia index represents endothelial dysfunction at the level of conduit as well as resistance vessels.|baseline, month 6||||Index||95% Confidence Interval|Least Squares Mean
2655130|NCT01628965|Primary|Skin Irritation Score of the Application Site|"Skin irritation score of the application site were evaluated according to the criteria below. The worst score throughout the treatment period was used in the analysis.~-: no reaction, ±: mild erythema, +: erythema, ++: erythema and Oedema, +++: erythema and oedema and rash papular, or serous papule, or vesicles, ++++: bullosum"|Up to 55 weeks after dosing|SS|||participants|||Number
2655026|NCT01630200|Primary|Change From Baseline in Carotid Femoral-Pulse Wave Velocity at Month 6|Carotid femoral-Pulse Wave Velocity (cf-PWV) will be measured non-invasively via applanation tonometry (AtCor Medical, Sydney, Australia). Wave propagation time will be calculated by the system software, using an ECG-gated reference frame. Aortic PWV is defined as the distance between two recording sites (i.e. common carotid- and femoral artery) divided by the wave propagation time.|baseline, month 6||||meters per second (m/s)||95% Confidence Interval|Least Squares Mean
2655027|NCT01630135|Secondary|Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant|The participant's parent/guardian who signed the ICF or the participant themself evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.|Week 2/EW|FAS|||participants|||Number
2655028|NCT01630135|Secondary|Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator|The investigator evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.|Week 2/EW|FAS|||participants|||Number
2655029|NCT01630135|Secondary|Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW|Rhinoscopy was assessed by the investigator by scoring swelling of inferior turbinate mucosa (SOITM) scored as 0 (none), 1 (possible to see center of the middle turbinate), 2 (between 3 and 1), or 3 (impossible to see middle turbinate); color of inferior turbinate mucosa (COITM) scored as 0 (normal), 1 (pink), 2 (red), or 3 (pale); quantity of nasal discharge (QTND) scored as 0 (none), 1 (small amount adhered), 2 (between 3 and 1), or 3 (filled); and quality of nasal discharge (QLND) scored as 0 (none), 1 (pyoid), 2 (viscous), or 3 (watery).|Baseline, Week 1, and Week 2/Early Withdrawal (EW)|FAS. Participants who were withdrawn before Visit 3 (Week 1) were not included in the analysis for Week 1.|||participants|||Number
2655030|NCT01630135|Secondary|Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2|The participant's parent/guardian who signed the ICF or the participant themself scored the participant's troubles with daily life once daily using the following scale: 0, None; 1, Few troubles; 2, Intermediate between 3 and 1; or 3, Painful and complicating daily life. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Scores on a scale||Standard Error|Least Squares Mean
2655031|NCT01630135|Secondary|Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Scores on a scale||Standard Error|Least Squares Mean
2655032|NCT01630135|Secondary|Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value * 100.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants with BL TOSS >0 who were available for assessment at both BL and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. Analysis was based on an ANCOVA with a model adjusting for Treatment, BL, Age, and Sex.|||Percent change||Standard Error|Least Squares Mean
2655160|NCT01628848|Secondary|UPDRS Part 2 Sum Score (Off State)|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state) at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2655033|NCT01630135|Secondary|Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's (par.) parent/guardian who signed the ICF or the par. themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the par.'s diary. The TOSS is the sum of all 3 symptom scores and ranges from 0 to 9. The mean of the BL period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each par. was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from BL=(mean score at post-BL assessment minus score at BL) divided by the BL value * 100. Par. with a BL TOSS of 0 were not analyzed because percent change from BL could not be calculated.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Percent change||Standard Error|Least Squares Mean
2655034|NCT01630135|Secondary|Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants with BL TOSS >0 who were available for assessment at both BL and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. Analysis was based on an ANCOVA with a model adjusting for Treatment, BL, Age, and Sex.|||Scores on a scale||Standard Error|Least Squares Mean
2655035|NCT01630135|Secondary|Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (Weeks 1 and 2), Week 1, and Week 2. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Scores on a scale||Standard Error|Least Squares Mean
2655036|NCT01630135|Secondary|Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2|Four individual symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching) were scored on a scale from 0 to 3 using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the symptom scores in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Scores on a scale||Standard Error|Least Squares Mean
2655037|NCT01630135|Secondary|Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2|The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 4TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Percent change||Standard Error|Least Squares Mean
2655038|NCT01630135|Secondary|Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2|The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Scores on a scale||Standard Error|Least Squares Mean
2655039|NCT01630135|Secondary|Mean Change From Baseline in 3TNSS at the Indicated Days|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). Change from Baseline was calculated as the mean score at the indicated day minus the score at Baseline.|Baseline; Days 1 through 14|FAS. Change from Baseline was analyzed for only those participants who were available for assessment at both Baseline and the indicated study day (Days 1 through 14). The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Scores on a scale||Standard Error|Least Squares Mean
2655040|NCT01630135|Secondary|Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire treatment period (Weeks 1 and 2), Week 1, and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (2 weeks), Week 1, and Week 2|FAS. Only those participants who were available for assessment at both Baseline and the indicated assessment period were analyzed. Participants were analyzed for the entire treatment period if they had an assessment on any day during Week 1 and Week 2. The analysis was based on an ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Percent change||Standard Error|Least Squares Mean
2655041|NCT01630135|Secondary|Mean Change From Baseline in 3TNSS at Week 1 and Week 2|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For Week 1 and Week 2, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score at Week 1 and Week 2 minus the score at Baseline.|Baseline; Week 1 and Week 2|FAS. Change from Baseline was analyzed for only those participants who were available for assessment at both Baseline and the indicated assessment period. The analysis was based on ANCOVA with a model adjusting for Treatment, Baseline, Age, and Sex.|||Scores on a scale||Standard Error|Least Squares Mean
2655042|NCT01630135|Primary|Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score for the entire treatment period minus the score at Baseline.|Baseline through the entire treatment period (2 weeks)|Full Analysis Set (FAS): all participants meeting the primary criteria for enrollment, without any major good clinical practice (GCP) deviation, who received at least one dose of the assigned treatment and had diary assessment for 3TNSS after receiving a dose of study medication|||Scores on a scale||Standard Error|Least Squares Mean
2655043|NCT01630109|Secondary|Difference in Pill Capsule Completion Rates in Diabetics vs. Non-diabetics|This study will investigate whether there is any difference in pill capsule completion rates in patients who are diabetic vs. those who are not diabetic.|12 hours||||Percentage of complete studies|||Number
2655044|NCT01630109|Secondary|Differences in Small Bowel Transit Time in Treatment vs. Placebo in Pill Capsule Studies|This study will investigate whether there is a difference in small bowel transit time in pill capsule studies with treatment with metoclopramide (5 mg or 10 mg) vs. placebo.|12 hours||||minutes||Standard Deviation|Mean
2655047|NCT01629966|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe).|Baseline to Week 8|The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of HAM-A.|||Score on Scale||Standard Deviation|Mean
2655048|NCT01629966|Primary|Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score|The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety.|Baseline to Week 8|The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of HAM-A.|||Score on scale||Standard Deviation|Mean
2655049|NCT01629953|Primary|Total Employment|Total amount employed over 1 year follow-up period|1 years||||Participants|||Count of Participants
2655050|NCT01629953|Primary|Employment|Number of veterans finding work within 6 months|within 6 months||||Participants|||Count of Participants
2655051|NCT01629862|Primary|Absolute Change in Brachial Artery Flow-mediated Dilation (FMD).|Brachial artery flow-mediated dilation is measured as the percent change in brachial artery diameter post-occlusion relative to pre-occlusion. The change in brachial artery flow mediated dilation is the difference in this percent change at 3-months compared to baseline.|3 months (compared to baseline)||||percentage of brachial artery diameter||Standard Deviation|Mean
2655052|NCT01629823|Primary|Methacholine Reactivity|The primary outcome measure was the change in provocative concentration of methacholine causing a 20% fall in forced expiratory volume in 1 second (FEV₁) (PC20) from baseline to 12 weeks. Modified American Thoracic Society guidelines were followed for pre-bronchodilator spirometry and methacholine challenge testing using the 5 breath dosimeter technique. Up to eleven doses, each a doubling concentration of methacholine (Provocholine™), were inhaled starting at 0.03 mg/mL until a 20% or greater fall in FEV₁ occurred; the maximum dose was 32 mg/mL. Breaths each of doubling concentrations of methacholine were inhaled from a calibrated DeVilbiss™ 646 nebulizer.|12 weeks after randomization||||mg/mL||95% Confidence Interval|Geometric Mean
2655053|NCT01629797|Secondary|Number of Correct Responses to Questionnaire Items Before and 2 Months After an Educational Lecture|In order to evaluate the long-term effect of an educational lecture about acne, subjects completed a questionnaire to assess knowledge about acne immediately before and two months after the educational lecture. The number of correct responses to each questionnaire item was calculated pre- and two months post-educational lecture.|before and 2 months after an educational lecture||||participants|||Number
2655054|NCT01629797|Primary|Number of Correct Responses to Questionnaire Items Immediately Before and After and Educational Lecture|In order to evaluate the immediate effect of an educational lecture about acne, subjects completed a questionnaire to assess knowledge about acne immediately before and after the educational lecture. The number of correct responses to each questionnaire item was calculated pre- and post-educational lecture.|immediately before and after an educational lecture||||participants|||Number
2655055|NCT01629784|Secondary|Percentage of Subjects Who Correctly Answered a Knowledge or Behavioral Assessment Item Before and 3 Months After an Educational Lecture|In order to evaluate the long-term effect of an educational lecture about cutaneous lupus erythematosus (CLE) and sun protection, subjects completed a questionnaire to assess knowledge about CLE and sun protection behaviors immediately before and three months after an educational lecture. The percentage of subjects who correctly answered a knowledge or behavioral assessment item were calculated pre- and three months post-educational lecture.|before and 3 months after an educational lecture||||percentage of participants|||Number
2655056|NCT01629784|Primary|Percentage of Subjects Who Correctly Answered a Knowledge Assessment Item Immediately Before and After an Educational Lecture|In order to evaluate the immediate effect of an educational lecture about cutaneous lupus erythematosus (CLE) and sun protection, subjects completed a written questionnaire to assess knowledge about CLE and sun protection immediately before and after the educational lecture. The percentage of subjects who correctly answered a knowledge assessment item were calculated pre- and post-educational lecture.|immediately before and after an educational lecture||||percentage of participants|||Number
2655057|NCT01629771|Primary|World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) Domain Scores|The WHODAS 2.0 is a generic health and disability assessment tool that describes effects of disease on six domains: Cognition, Mobility, Self-Care, Getting Along, Life Activities, and Participation in Society. Responses are measured on a 5-point scale from 1 (no difficulty) to 5 (extreme difficulty or cannot do). Scores are calculated using a WHO SPSS 36 version syntax for employed subjects and a WHO SPSS 32 version syntax for unemployed subjects. Scores for each domain range from 0 to 100, where 0 is associated with no impairment of health status, and 100 is associated with a greater impairment of health status.|Assessed after enrollment||||units on a scale||Inter-Quartile Range|Median
2655058|NCT01629771|Primary|Lymphatic Filariasis-Specific Quality of Life (LFSQQ) Domain Scores|The LFSQQ was developed to assess quality of life in subjects with lymphatic filariasis through seven domains: Mobility, Self-Care, Usual Activities, Disease Burden, Pain/Discomfort, Psychological Health, and Social Participation. Items are scored on a 5-point scale (no problem, mild, moderate, severe, most severe), and scores for each domain are calculated based on the number of questions answered and the raw scores. Scores for each domain range from 0 to 100, where 0 is associated with a worse quality of life and 100 is associated with a better quality of life.|Assessed after enrollment||||units on a scale||Inter-Quartile Range|Median
2655059|NCT01629771|Primary|Dermatology Life Quality Index (DLQI) Domain Scores|The DLQI is a 10-item questionnaire measuring skin-specific quality of life through six domains: Symptoms & Feelings, Daily Activities, Leisure, Work & School, Personal Relationships, and Treatment. Symptoms & Feelings, Daily Activities, Leisure, and Personal Relationships are each scored from 0 to 3, where 0 is associated with no effect on a patient's life, and 3 is associated with a large effect on a patient's life. Work & School and Treatment are each scored from 0 to 3, where 0 is associated with no effect on a patient's life, and 6 is associated with a large effect on a patient's life.|Assessed after enrollment||||units on a scale||Inter-Quartile Range|Median
2655060|NCT01629706|Primary|Ratio of Viable and Non-Viable Epithelial Cells at Day 1 and Week 4, Phase 2|The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and incubated with live/dead stains. Cells collected from the right and the left eye were combined; cells collected from the right and the left lens were combined. The number of viable and non-viable cells was counted using a microscope. The ratio between viable and non-viable cell counts was calculated. A higher number indicates a higher percentage of non-viable cells relative to the total cell count.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.|||percentage of cells||Standard Deviation|Mean
2655061|NCT01629706|Primary|Ratio of Epithelial Cells Collected Directly From the Ocular Surface and Cells Collected From the Contact Lens at Day 1 and Week 4, Phase 2|The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and cells collected from the right and the left eye were combined; cells collected from the right and the left lens were combined. The ratio of cells collected from the ocular surface and from the contact lens was calculated. A higher number indicates a higher percentage of cells collected from the contact lenses relative to the total number of cells collected.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.|||percentage of cells||Standard Deviation|Mean
2655062|NCT01629706|Primary|Mean Number of Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of cells (viable and non-viable) was counted using a microscope. Cells collected from right and left eyes were pooled. Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.|||cells||Standard Deviation|Mean
2655063|NCT01629706|Primary|Mean Number of Epithelial Cells Collected From the Contact Lens at Day 1 and Week 4, Phase 2|The worn contact lenses were removed and transferred into well plates, each containing a soaking solution. Following a soaking duration of approximately 30 minutes, lenses were rinsed and transferred in individual glass vials. The cell content from the lens wash was taken to a laboratory and incubated with live/dead stains. The total number of cells (viable and non-viable) were counted using a microscope. Cells collected from right and left lens were pooled. Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.|||cells||Standard Deviation|Mean
2655064|NCT01629706|Primary|Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of non-viable cells was counted using a microscope. Cells collected from right and left eyes were pooled.Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.|||cells||Standard Deviation|Mean
2655065|NCT01629706|Primary|Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface at Day 1 and Week 4, Phase 2|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of viable cells was counted using a microscope. Cells collected from right and left eyes were pooled. Samples were collected after 8 hours of wear. A significant difference in cell count may indicate a physiological response to contact lens wear due to lens age.|Day 1 and Week 4|This reporting group included all participants that completed Phase 2 of the study with expected in-range responses.|||cells||Standard Deviation|Mean
2655066|NCT01629706|Primary|Ratio of Viable and Non-Viable Epithelial Cells After 2 Hours and 4 Hours of Wear, Phase 1|"The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and incubated with live/dead stains. Cells collected from each lens and each eye were counted separately using a microscope. The number of viable and non-viable cells was counted using a microscope. The ratio between viable and non-viable cell counts was calculated.~A higher number indicates a higher percentage of non-viable cells relative to the total cell count."|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.|||percentage of cells||Standard Deviation|Mean
2655067|NCT01629706|Primary|Ratio of Epithelial Cells Collected Directly From the Ocular Surface and Cells Collected From the Contact Lens After 2 Hours and 4 Hours of Wear, Phase 1|The worn contact lenses were removed, rinsed and transferred in individual glass vials. Epithelial cells were collected directly from the ocular surface using an eyewash. Samples were taken to a laboratory and cells collected from each lens and each eye were counted separately using a microscope. The ratio of cells collected from the ocular surface and from the contact lens was calculated. A higher number indicates a higher percentage of cells collected from the contact lenses relative to the total number of cells collected.|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.|||percentage of cells||Standard Deviation|Mean
2655105|NCT01629563|Secondary|Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life -Uterine Fibroid Health Related Quality of Life (HRQL)|"Quality of Life was measured using a validated uterine fibroid symptom questionnaire. Total score for health related quality of Life (HRQL) range from 0 to 100 with higher scores indicating better Quality of Life.~Subjects were exposed to 4 3-month intermittent courses."|18 months|Full Analysis Set 1 (all subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis)|||percentage of change from baseline||Inter-Quartile Range|Median
2655068|NCT01629706|Primary|Mean Number of Fluorescein-Stained Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory. The total number of fluorescein-stained cells was counted using a microscope. Cells collected from the right and the left eye were analyzed separately. A significant difference in fluorescein-stained cell count may indicate a physiological response to the contact lens and/or care regimen over time.|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.|||cells||Standard Deviation|Mean
2655069|NCT01629706|Primary|Mean Number of Non-Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1|The worn contact lenses were removed and epithelial cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/dead stains. The number of non-viable (dead) cells was counted using a microscope. Cells collected from the right and the left eye were analyzed separately. A significant difference in non-viable cell count may indicate a physiological response to the contact lens and/or care regimen over time.|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.|||cells||Standard Deviation|Mean
2655070|NCT01629706|Primary|Mean Number of Viable Epithelial Cells Collected Directly From the Ocular Surface After 2 Hours and 4 Hours of Wear, Phase 1|The worn contact lenses were removed and epithelial (corneal) cells were collected directly from the ocular surface using an eyewash. Immediately following the eyewash, samples were taken to a laboratory and incubated with live/ dead stains. The number of viable (alive) cells was counted using a microscope. Cells collected from the right and the left eye were analyzed separately. A significant difference in viable cell count may indicate a physiological response to the contact lens and/or care regimen over time.|Day 1 after 2 hours of wear; Day 7 after 4 hours of wear|This reporting group included all participants that completed Phase 1 of the study with expected in-range responses.|||cells||Standard Deviation|Mean
2655071|NCT01629693|Primary|"Change From Baseline in Likert Response: I Can Comfortably Wear my Lenses at Day 30"|Overall comfort was assessed by the participant as a response to the questionnaire item 'I can comfortably wear my lenses', using a 10-point Likert scale, with 1=poor and 10=excellent.|Baseline, Day 30|This analysis population includes all participants who completed the protocol and had no major protocol violations.|||units on a scale||Standard Deviation|Mean
2655072|NCT01629667|Secondary|Percentage of Participants Positive for Anti-Drug Antibodies to Tralokinumab|A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.|From the start of study treatment through Week 88|"The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received. Here, n is number of participants analysed at given time point."|||Percentage of participant|||Number
2655073|NCT01629667|Secondary|Mean Serum Concentration of Tralokinumab|The mean serum concentration of Tralokinumab were observed.|Predose, 0 hour, and 2 hour postdose on Week 0; predose on Week 4, 48, 72, 82 and 88|"The Pharmacokinetic population included all participants who received at least one dose of tralokinumab and had at least one detectable trough (Weeks 4, 48 or 72 only) serum concentration measurement. Here, n is number of participants analysed at given time point."|||microgram per milliliter (mcg/ml)||Standard Deviation|Mean
2655074|NCT01629667|Secondary|Number of Participants With Patient Global Impression of Change (PGI-C) for Idiopathic Pulmonary Fibrosis (IPF)|The PGI-C is a single-item, global assessment designed to capture participant-perceived change in their IPF health condition using a 7-point scale (-3 = very much improved, 0 = no change, about the same, 3 = very much worse).|Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, N is number of participants analysed for this outcome measure."|||Participant|||Number
2655075|NCT01629667|Secondary|Number of Participants With Patient Global Impression of Severity (PGI-S) for Idiopathic Pulmonary Fibrosis (IPF)|The PGI-S is a single-item, global assessment of participant-perceived IPF severity. The assessment was designed to capture participant perceived IPF-related health status. Participants rate their IPF severity using a 5-point scale (1 = very mild, 5 = very severe).|Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, N is number of participants analysed for this outcome measure."|||Participant|||Number
2655076|NCT01629667|Secondary|Change From Baseline in European Quality of Life-5-Dimension 3 Level Version (EQ-5D-3L) (Including Visual Analog Scale [VAS]) at Week 72|The EQ-5D-3L is a standardized PRO used to capture respondent's general health status. The questionnaire assesses 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 response options (no problem, some or moderate problems, and unable or extreme problems) that reflect increasing levels of difficulty. The questionnaire also includes a visual analog scale, where the participants were asked to rate their current health on a scale of 0-100, with 0 being the worst imaginable health state.|Baseline and Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Units on a scale||Standard Deviation|Mean
2655077|NCT01629667|Secondary|Change From Baseline in Exacerbations of Chronic Pulmonary Disease (EXACT IPF) Total Score Through Week 72|The EXACT-IPF is a 14-item daily dairy used to capture the IPF related symptoms completed by the participants using an eDiary. The EXACT-IPF total score is the sum of all items ranged from 1 to 14. EXACT-IPF is an interval-level scale ranging from 0 to 100, where the higher scores indicate more severe condition. The EXACT-IPF used Likert scales (with 3 to 6 response options each) to capture participant reported IPF-related symptoms. The scores are the simple sum of item responses for each domain or single item.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Units on a scale||Standard Deviation|Mean
2655078|NCT01629667|Secondary|Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 72|The SGRQ is a 50-item Patient-reported outcome (PRO) instrument developed to measure respiratory-related health status via 76 weighted responses. The SGRQ is divided into two parts. Part 1 asks respondents to consider the last 3 months and report on their respiratory symptoms using 5-point Likert scales. Part 2 asks respondents to consider their current state and respond to a series of dichotomous yes/no items related to their activities (activities that cause or were limited by breathlessness) and impacts (social functioning, psychological disturbances resulting from airways disease). Total scores and domain scores (symptoms, activities, and impact on daily life) were scored from 0-100, where lower scores indicate better health status.|Baseline and Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Units on a scale||Standard Deviation|Mean
2655079|NCT01629667|Secondary|Change From Baseline in University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score at Week 72|The UCSD SOBQ is a 24-item questionnaire designed to capture patient-reported shortness of breath. Respondents were asked to rate their breathlessness during 21 activities of daily living using a 6-point scale (0 = not at all breathless, 5 = maximally breathless or too breathless to do this activity). In addition to the 21 activity items, the UCSD SOBQ includes 3 additional questions about limitations due to shortness of breath, fear of harm from overexertion, and fear of shortness of breath. The UCSD SOBQ was scored by summing responses across all 24 items to form a total score. Scores range from 0-120 with higher scores indicative of greater shortness of breath.|Baseline and Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Units on a scale||Standard Deviation|Mean
2655080|NCT01629667|Secondary|Number of Participants With Clinical Global Impression of Change Scores|The CGI-C is a single, clinician completed, item designed to capture the clinicians overall impression of change in IPF severity from the baseline state at Screening. Clinicians were asked to rate the participants IPF severity relative to their state at baseline using a 7-point scale (-3 = very much worse, 0 = no change, about the same, 3 = very much improved).|Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, N is number of participants analysed for this outcome measure."|||Participant|||Number
2655081|NCT01629667|Secondary|Number of Participants With Clinical Global Impression of Severity Scores|The CGI-S is a single, clinician completed, item designed to capture the clinician's impression of the participants IPF severity. Clinicians were asked to consider their experience in this participant population and rate the overall IPF severity of the participant using a 5-point scale (1 = very mild, 5 = very severe).|Week 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, N is number of participants analysed for this outcome measure."|||Participant|||Number
2655082|NCT01629667|Secondary|Change From Baseline in Absolute Forced Vital Capacity (FVC) Through Week 72|Forced vital capacity (FVC) is a standard pulmonary function test used to monitor disease progression in IPF. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Liter||Standard Deviation|Mean
2655083|NCT01629667|Secondary|Change From Baseline in Percent-predicted FEV1 Through Week 72|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FEV1 = (observed value)/(predicted value) * 100%.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Percent of predicted FEV1||Standard Deviation|Mean
2655084|NCT01629667|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Through Week 72|FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Liter||Standard Deviation|Mean
2655085|NCT01629667|Secondary|Percentage of Participants With Adjudicated Hospitalization|Participants who were hospitalized due to IPF exacerbation were observed. All events that resulted in the hospitalization of participants were adjudicated by an independent committee to determine if the event was due to an IPF exacerbation as follows: 1. Exacerbation or progression of IPF, 2. Result of a complication of IPF, 3. Not related to IPF (alternative diagnosis provided), and 4. Undetermined due to insufficient information.|Week 52 and 72|The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.|||Percentage of participant|||Number
2655086|NCT01629667|Secondary|Percentage of Participants With Adjudicated Mortality|Participants all cause mortality were observed. Events that resulted in participant death were adjudicated into respiratory-related mortality or all other cause mortality by an independent committee.|Week 52 and 72|The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.|||Percentage of participant|||Number
2655106|NCT01629563|Secondary|Percentage of Change From Baseline to End of Treatment Course 4 in Quality of Life (Uterine Fibroid Symptom Severity (UFSQoL)|"Quality of Life was assessed using a validated questionnaire measuring uterine fibroid symptom severity (UFSQoL) where lower scores indicate fewer symtoms and where a level of 23 has been reported for healthy subject (scale 0-100).~Subjects were exposed to 4 3-month intermittent courses."|After 18 months|Full Analysis Set 1 (all subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis)|||percentage of change from baseline||Inter-Quartile Range|Median
2655087|NCT01629667|Secondary|Percentage of Participants With Idiopathic Pulmonary Fibrosis (IPF) Exacerbations|"The IPF exacerbations is defined as an acute, clinically significant, deterioration of unidentifiable cause in a participant with underlying IPF. Exacerbations of IPF were adjudicated according to the protocol definition by an independent committee as follows:~1. Confirmed acute IPF exacerbation, 2. Suspected acute IPF exacerbation, 3. Not an IPF exacerbation with an alternative diagnosis provided if possible, and 4. Undetermined due to insufficient information."|Week 52 and 72|The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.|||Percentage of participant|||Number
2655088|NCT01629667|Secondary|Change From Baseline in Lung Volumes Through Week 72|Lung volumes were evaluated by total lung capacity (TLC), residual volume (RV), and vital capacity (VC). Lung volumes were determined by body plethysmography.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Liter||Standard Deviation|Mean
2655089|NCT01629667|Secondary|Change From Baseline in Oxygen Saturation by Pulse Oximetry at Week 68|Participants transcutaneous oxygen saturation were observed by pulse oximetry.|Baseline and Week 68|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Percent of oxygen saturation||Standard Deviation|Mean
2655090|NCT01629667|Secondary|Change From Baseline in 6 Minute Walk Test (6MWT) Distance Through Week 72|The 6MWT measures the distance that a participant can walk on a measured, flat hard surface in a period of 6 minutes. The 6MWT evaluates the global and integrated responses of all body systems involved during walking.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Meter||Standard Deviation|Mean
2655091|NCT01629667|Secondary|Change From Baseline in Haemoglobin (Hb) Corrected Percent-predicted Diffusion Capacity for Carbon Monoxide (DLco) Through Week 72|The single breath technique was used to determine the DLco. The test was performed by qualified pulmonary function technicians with experience performing this study. Acceptable test criteria included:• An inspiratory volume of more than 85% of vital capacity. • A stable breath hold of 10 seconds (+/- 2 seconds) with no leaks, Valsalva or Mueller maneuvers. • Expiration in less than 4 seconds with appropriate clearance of dead space. The average of the two best acceptable maneuvers was used. There must be a minimum of 4 minutes between the performances of each test.|Baseline, Week 52 and 72|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Percent predicted DLco||Standard Deviation|Mean
2655092|NCT01629667|Secondary|Percentage of Participants With Disease Progression|Progression-free Survival (PFS) was used to evaluate disease progression and the percentage of participants with disease progression. A participant was classified as having disease progression if at least one of the following criteria were met:• Adjudicated respiratory-related mortality. •Adjudicated hospitalization due to IPF exacerbation. •Confirmed decline in percent-predicted FVC of greater than or equal to (>=) 10%. •Confirmed decline in 6 minute walk test (6MWT) >= 50 meters.|Week 52 and 72|The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization.|||Percentage of Participant|||Number
2655093|NCT01629667|Secondary|Number of Participants With Electrocardiogram Abnormalities Reported as Treatment-emergent Adverse Events|AEs observed in participants with clinically significant ECG abnormalities were assessed. Tricuspid valve incompetence was the only abnormality reported as TEAE. ECG parameters included heart rate, PR, QRS, QT, and QTc intervals. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state.|From the start of study treatment through Week 88|The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.|||Participant|||Number
2655094|NCT01629667|Secondary|Number of Participants With Vital Signs and Physical Findings Abnormalities Reported as Treatment-emergent Adverse Events|Vital signs parameters included heart rate, blood pressure, temperature, weight, pulse oximetry and respiratory rate. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state.|From the start of study treatment through Week 88|The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.|||Participant|||Number
2655095|NCT01629667|Secondary|Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-emergent Adverse Events|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pre-treatment state. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.|From the start of study treatment through Week 88|The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.|||Participant|||Number
2655107|NCT01629563|Secondary|Percentage of Change From Baseline to End of Treatment Course 4 in the Total Volume of the 3 Largest Fibroids|"For the 3 largest myomas at baseline and the 3 largest myomas at the end of treatment course 4 identified by transvaginal ultrasound, length, height and depth were measured and the volume was estimated by applying the equation for the voulme of an ellipsoid (length x height x depht x π/6).~Subjects were exposed to 4 3-month intermittent courses."|After 18 months|Full Analysis Set 1 (all subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis)|||percentage of change from baseline||Inter-Quartile Range|Median
2655096|NCT01629667|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|Any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received Tralokinumab. Treatment-emergent were events between administration of investigational product and Week 88 that were absent before treatment or that worsened relative to pretreatment state.|From the start of study treatment through Week 88|The safety population included all participants who received any study investigational product and participants were analysed according to the treatment they actually received.|||Participant|||Number
2655097|NCT01629667|Primary|Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 52|Forced vital capacity (FVC) is a standard pulmonary function test used to monitor disease progression in IPF. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%.|Baseline and Week 52|"The intent-to-treat (ITT) population included all randomized participants who received any study investigational product and participants were analysed according to the randomization. Here, n is number of participants analysed at given time point."|||Percentage of predicted FVC||Standard Deviation|Mean
2655098|NCT01629589|Secondary|Number of Participants Reporting Immediate Unsolicited Adverse Events Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|The occurrence, nature (Medical Dictionary for Regulatory Activities (MedDRA) preferred term), duration, intensity, and relationship to vaccination of adverse events (AEs) reported in the 15 minutes after vaccination and systemic AEs.|Up to 15 minutes post-vaccination|Number of participants reporting immediate unsolicited adverse events was determined in all participants in the Safety Analysis Set.|||Participants|||Number
2655099|NCT01629589|Secondary|Number of Participants With Booster Responses Against the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|"Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre vaccination concentration ≤93 ELISA Unit (EU)/mL for Pertussis toxoid (PT), ≤170 EU/mL for Filamentous hemagglutinin (FHA), ≤115 EU mL for pertactin (PRN), or ≤285 EU/mL for Fimbriae types 2 and 3 (FIM), and defined as a 2-fold increase for subjects with a pre-vaccination concentration >93 EU/mL for PT, >170 EU/mL for FHA, >115 EU/mL for PRN, or >285 EU/mL for FIM.~Boostrix booster response defined as: a post-vaccination titer ≥4 times the LLOQ for subjects with a pre-vaccination titer <LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ."|Day 28 post-vaccination|Booster response against Pertussis antibodies were determined in the Per-Protocol Analysis Set.|||Participants|||Number
2655100|NCT01629589|Secondary|Geometric Mean Concentrations of the Pertussis Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|Pertussis antibodies Pertussis toxoid (PT), Filamentous hemagglutinin (FHA), Pertactin (PRN), and Fimbriae types 2 and 3 (FIM 2&3) were assayed by Enzyme-linked immunosorbent assay (ELISA)|Day 0 (pre-vaccination) to Day 28 post-vaccination|Geometric mean concentrations of the Pertussis antibodies were determined in the Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2655101|NCT01629589|Secondary|Number of Participants With Booster Responses Against Tetanus and Diphtheria Antigens Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|"Adacel booster response defined as: a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with a pre-vaccination concentration ≤2.56 IU/mL for diphtheria and ≤2.7 IU/mL for tetanus, and defined as a 2-fold increase for subjects with a pre-vaccination concentration >2.56 IU/mL for diphtheria and >2.7 IU/mL for tetanus.~Boostrix booster response defined as: a post-vaccination titer ≥4 times the lower limit of quantitation (LLOQ) for subjects with a pre-vaccination titer < LLOQ, a post-vaccination titer ≥4 times the pre-vaccination titer for subjects with a pre-vaccination titer between LLOQ and 4x LLOQ, or a post-vaccination titer at least twice the pre-vaccination titer for subjects with a pre-vaccination titer ≥4x LLOQ."|Day 28 post-vaccination|Booster response against tetanus and diphtheria components were determined in the Per-Protocol Analysis Set.|||Participants|||Number
2655102|NCT01629589|Secondary|Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test|Day 0 (pre-vaccination) to Day 28 post-vaccination|The geometric mean concentrations of tetanus and diphtheria antibodies were determined in the Per Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2655103|NCT01629589|Primary|Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine|Tetanus antibody was assayed by Enzyme-linked immunosorbent assay (ELISA) and Diphtheria antibody by a toxin neutralization test. Antibody responses to tetanus and diphtheria components were defined as titers ≥0.1 IU/mL and ≥1.0 IU/mL|Day 0 (pre-vaccination) to Day 28 (post-vaccination)|The antibody responses to tetanus and diphtheria components were determined in the Per-Protocol Analysis Set.|||Participants|||Number
2655104|NCT01629563|Secondary|Percentage of Change From Baseline to End of Treatment Course 4 in Pain Using a Visual Analogue Scale (VAS)|"Pain was assessed using a Visual Analogue Scale (VAS) ranging from 0 to 100 with higher score indicating more severe pain.~Subjects were exposed to 4 3-month intermittent courses."|After 18 months|FAS1 (all subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis)|||percentage of change from baseline||Inter-Quartile Range|Median
2655127|NCT01629134|Secondary|Bruising of the Lips|Injector assessment of whether there was none, little, some, moderate, or considerable bruising in subjects' lips|15 minutes after injection|All subjects who met the criteria and treatment was initiated|||Percentage of subjects|||Number
2655108|NCT01629563|Secondary|Percentage of Subjects With Controlled Bleeding at the End of All 4 Treatment Courses|"Controlled bleeding was defined as no episodes of heavy bleeding and a maximum of 8 days of bleeding during the last 56 days of a treatment course.~Subjects need to be in controlled bleeding at the end of all 4 treatment courses i.e. for at least 4x56 days."|After 18 months|Full analysis set 1 (all subject who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis)|||percentage of participants|||Number
2655109|NCT01629563|Secondary|Percentage of Subjects Who Were in Amenorrhea at the End of Treatment Course 4|Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval.|After 18 months|Full Analysis Set 1 (all subjects who received study treatment once for treatment course 1) (subjects with missing values were excluded from analysis)|||percentage of participants|||Number
2655110|NCT01629563|Primary|Percentage of Subjects Who Are in Amenorrhea at the End of All Four Treatment Courses|Amenorrhoea was defined as no more than 1 day of spotting within a 35 day interval. Subjects need to be in amenorrhoea at the end of all four treatment courses, i.e for at least 4x35 days.|18 months study duration per subject (4 3-month intermittent treatment courses)|Full Analysis Set 1 (subjects who received study treatment at least once for treatment course 1) (subjects with missing values were excluded from analysis)|||percentage of subjects|||Number
2655111|NCT01629511|Other Pre-specified|Acute and Chronic Graft Verse Host Disease (GvHD)|GvHD (Graft versus Host Disease) occurs when immune cells transplanted from a non-identical donor (graft) recognizes the transplant recipient (the host) as foreign, thereby initiating an immune reaction in the transplant recipient. Acute GvHD typically occurs around the time of engraftment and manifests in skin, GI system, and liver abnormalities. Chronic GvHD is defined by manifestations such as ocular, oral, lung, sclerosis skin, failure to thrive, fascia, cholestasis in liver, esophagus strictures.|Up to 1 year post transplant|Analysis was for Phase II. No analysis was done due to low accrual on Phase I.||||||
2655112|NCT01629511|Other Pre-specified|Time-to-engraftment|The number of days until participants by dose level reach engraftment.|30 days post transplant|No participants were treated at dose level 2.|||participants|||Number
2655113|NCT01629511|Other Pre-specified|Progression-free Survival (PFS)|Number of patients without any relapse post treatment completion|Up to 1 year post transplant|Analysis was for Phase II. No analysis was done due to low accrual on Phase I.||||||
2655114|NCT01629511|Secondary|Overall Survival|Will be estimated by the method of Kaplan and Meier. Time-to-event distributions as function of patient baseline covariates will be evaluated using Bayesian time-to-event regression modeling.|Up to 1 year post transplant|All participants were registered on Phase I.|||Participants|||Count of Participants
2655115|NCT01629511|Primary|Maximum Tolerated Dose (MTD)|To find the maximum tolerated dose (MTD) of Gemcitabine when administered with Busulfan & Clofarabine|Enrollment up to day 30 post transplant|MTD analysis was for Phase II. Data were not collected.||||||
2655116|NCT01629511|Primary|100 Day Treatment Related Mortality (TRM)|Number of deaths related to treatment by day 100 post allogeneic transplant|100 days post transplant|No participants were treated at dose level 2.|||Participants|||Count of Participants
2655117|NCT01629329|Secondary|Number of Reported Adverse Side-effects|Secondary endpoints will also be assessed at 30min, 90min and 120min. Additional secondary endpoints will be in the number of reported adverse side-effects, defined as muscle spasm, tiredness, extreme restlessness, GI upset, vomiting in the ED and treatment failure rate.|30, 90, and 120 minutes from drug administration|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2655118|NCT01629329|Primary|Mean Difference From Baseline of VAS Pain Scores|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available|60 minutes from drug administration|0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available||||||
2655119|NCT01629290|Primary|Fluoride Concentration and Release|Fluoride release as measured by concentration of fluoride available in the oral cavity at different time periods after the application of 5% NaF varnish and placebo as measured in unstimulated human saliva|Baseline, 1 hr, 4 hrs, 6 hrs, 26 hrs and 50 hrs|The 15 participants were each involved in each of the successive treatments with Enamel Pro, Duraphat, Vanish, and Placebo, (the order differed for each participant), and to show the differences between baseline and the different treatment levels, the baselines before each of the treatments is listed here along with the relevant treatment.|||ppm||Standard Deviation|Mean
2655120|NCT01629134|Secondary|Rating of Injection Discomfort|The level of discomfort during treatment on a scale of 0 (no discomfort) to 10 (extreme discomfort).|15 minutes after injection|All subjects who met the criteria and treatment was initiated|||scale score||Standard Deviation|Mean
2655121|NCT01629134|Secondary|Comparative Rating With Previous Treatment|Subject rating of lip improvement with VOLBELLA compared with previous lip enhancement treatments as significantly better, somewhat better, no difference, somewhat worse, or significantly worse|15 minutes after injection|All subjects who met the criteria and treatment was initiated|||Percentage of subjects|||Number
2655122|NCT01629134|Secondary|Return to Social Engagement|Time to return to normal daily activities|4 weeks|All subjects who met the criteria and treatment was initiated|||Percentage of subjects|||Number
2655123|NCT01629134|Secondary|Need for Massage|Injectors rated whether none/minimal, a little, some, or a lot of massage was required to optimize placement of VOLBELLA|15 minutes after injection|All subjects who met the criteria and treatment was initiated|||Percentage of subjects|||Number
2655124|NCT01629134|Secondary|Malleability of Product|Injectors rated the malleability on a scale ranging from 0 (Extremely malleable/Not hard to mold) to 10 (Not malleable/Hard to mold)|15 minutes after injection|All subjects who met the criteria and treatment was initiated|||Percentage of subjects|||Number
2655125|NCT01629134|Secondary|Ease of Injection|Injectors rated the ease of injection on a scale ranging from 0 (Very easy) to 10 (Extremely difficult)|15 minutes after injection|All subjects who met the criteria and treatment was initiated|||Percentage of subjects|||Number
2655126|NCT01629134|Secondary|Swelling of the Lips|Injector assessment of whether there was none, little, some, moderate, or considerable swelling in subjects' lips|15 minutes after injection|All subjects who met the criteria and treatment was initiated|||Percentage of subjects|||Number
2655131|NCT01628965|Secondary|Total of Unified Parkinson's Disease Rating Scale (UPDRS) Part 2 Sum Score and Part 3 Sum Score|Mean change (LOCF) from baseline in Total of UPDRS Part 2 sum score and Part 3 sum up to 54 weeks after dosingUPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement.|Baseline, Up to 54 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
2655132|NCT01628965|Primary|Incidence and Severity of Adverse Events, Vital Signs, and Laboratory Parameters|"Incidence and severity of adverse events, vital signs, and laboratory parameters up to 54 weeks after dosing.~*decrease in difference between supine and standing systolic blood pressure"|Up to 55 weeks after dosing|Safety set (SS)|||participants|||Number
2655133|NCT01628926|Secondary|Dystonia (in the Daytime)|Change (LOCF) from baseline in occurrence of Dystonia (in the daytime).|Baseline, 16 weeks after dosing|Appropriate interpretation for this outcome measure was not possible, because 87.1% (142/163), 88.5% (146/165), and 91.4% (74/81) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had no dystonia in the day time at baseline.|||Percentage of Participants|||Number
2655134|NCT01628926|Secondary|Dystonia (at an Early Hour)|Change (LOCF) from baseline in occurrence of Dystonia (at an early hour).|Baseline, 16 weeks after dosing|FAS, LOCF Evaluation for this outcome measure was not possible, because 87.1% (142/163), 88.5% (146/165), and 91.4% (74/81) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had no dystonia in the day time at baseline.|||Percentage of participants|||Number
2655135|NCT01628926|Secondary|Clinical Global Impression (CGI)|"Change (LOCF) from baseline in CGI score. CGI improvement is a clinician-reported scale for assessing how much the patient's illness has improved or worsened from baseline.~The scale scoring criteria are 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse. A decrease in the scores means improvement."|Baseline, 16 weeks after dosing|FAS, LOCF|||Percentage of Participants|||Number
2655136|NCT01628926|Secondary|Effective Rate in Off Time|"Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in off time at 16 weeks after dosing.~On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day."|Baseline, 16 weeks after dosing|FAS subjects with measurable off time data at baseline, LOCF|||Percentage of participants||95% Confidence Interval|Number
2655137|NCT01628926|Secondary|Effective Rate in UPDRS Part 2 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing.|Baseline, 16 weeks after dosing|FAS, LOCF|||Percentage of participants||95% Confidence Interval|Number
2655138|NCT01628926|Secondary|Effective Rate in UPDRS Part 3 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 3 sum score (on state) at 16 weeks after dosing.|Baseline, 16 weeks after dosing|FAS, LOCF|||Percentage of participants||95% Confidence Interval|Number
2655139|NCT01628926|Secondary|On Time With Dyskinesia Disturbing Daily Activities|Mean change (LOCF) from baseline in on time with dyskinesia disturbing daily activities at 16 weeks after dosing (rate against on time).|Baseline, 16 weeks after dosing|FAS, LOCF Evaluation for this outcome measure was not possible, because only 22.6% (37/164), 12.7% (21/165), and 6.0% (5/83) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had dyskinesia disturbing daily activities on either day from baseline until the end of titration/maintenance period.|||Hours||Standard Deviation|Mean
2655140|NCT01628926|Secondary|On Time Without Dyskinesia Disturbing Daily Activities|"Mean change (LOCF) from baseline in on time without dyskinesia disturbing daily activities at 16 weeks after dosing.~On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day."|Baseline, 16 weeks after dosing|FAS, LOCF Evaluation for this outcome measure was not possible, because only 22.6% (37/164), 12.7% (21/165), and 6.0% (5/83) of the subjects in the SPM 962, Ropinirole, and Placebo groups, respectively, had dyskinesia disturbing daily activities on either day from baseline until the end of titration/maintenance.|||Hours/day||Standard Deviation|Mean
2655141|NCT01628926|Secondary|On Time|Mean change (LOCF) from baseline in on time at 16 weeks after dosing. On-time is a state where L-Dopa is effective. On-time was measured by patient diary in hours/day.|Baseline, 16 weeks after dosing|FAS, LOCF|||Hours/day||Standard Deviation|Mean
2655142|NCT01628926|Secondary|Parkinson's Disease Sleep Scale-2 (PDSS-2)|Mean change (LOCF) from baseline in PDSS-2 sum score at 16 weeks after dosing. PDSS-2 is a scale for assessing sleep disorders in Parkinson's disease. PDSS consists of 15 questions about sleep and nocturnal disturbances. The score of each question ranges from 0 (never) to 4 (very frequent). The sum of each question serves as the scale score. Thus a decrease in the scores means improvement.|Baseline, 16 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2655143|NCT01628926|Secondary|Off Time|Mean change (LOCF) from baseline in off time at 16 weeks after dosing. Off-time is a state where L-Dopa becomes ineffective. Off-time was measured by patient diary in hours/day.|Baseline, 16 weeks after dosing|FAS subjects with measurable off time data at baseline, LOCF|||Hours/day||Standard Deviation|Mean
2655144|NCT01628926|Secondary|UPDRS Part 2 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) at 16 weeks after dosing.~UPDRS 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 16 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2655145|NCT01628926|Secondary|UPDRS Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 8 and 10 weeks after dosing.~UPDRS Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 8 and 10 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2655213|NCT01628198|Primary|Change in Ambulatory Diastolic Blood Pressure|The change in diastolic blood pressure as measured by 24 hour ambulatory monitoring at 6 months as compared to from baseline.|baseline and 6 months|analysis for participants who returned for follow up|||mmHg mean change||Standard Deviation|Mean
2655146|NCT01628926|Primary|Unified Parkinson's Disease Rating Score (UPDRS) Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state) at 16 weeks after dosing.~UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 16 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
2655147|NCT01628913|Secondary|Time to Treatment Failure (TTF)|Time from randomization to the date of the first of the following events:death due to any cause or progressive disease, treatment discontinuation due to toxicity or treatment discontinuation due to patient preference|up to approx. 18 months|Trial terminated based on the results of an interim analysis of the primary OM ( which demonstrated BEX235 not having improved PFS (progression free survival) vs everolimus).The secondary OM analyses were not conducted.||||||
2655148|NCT01628913|Secondary|Overall Survival (OS)|Time from randomization to the date of death due to any cause|up to approx. 30 months|Trial terminated based on the results of an interim analysis of the primary OM ( which demonstrated BEX235 not having improved PFS (progression free survival) vs everolimus).The secondary OM analyses were not conducted.||||||
2655149|NCT01628913|Secondary|Objective Response Rate|Proportion of patients with a best overall response during the study of complete response (CR) or partial response (PR), based on the investigator assessment. 2. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for all target and non-target lesions, as well as new lesions as assessed by CT or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of all target lesions; Overall Response (OR) = CR + PR.|up to approx. 18 months|Trial terminated based on the results of an interim analysis of the primary OM ( which demonstrated BEX235 not having improved PFS (progression free survival) vs everolimus).The secondary OM analyses were not conducted.||||||
2655150|NCT01628913|Primary|Progression Free Survival (PFS)|PFS is defined as the time from the date of randomization until the date of the first radiologically documented disease progression or death due to any cause. PFS is based on local investigator assessment. Patients will be followed up for the duration of the study and for an expected average of every 12 weeks after randomization. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of all target lesions, or unequivocal progression of non-target lesions, or the appearance of new lesions.|up to approx. 18 months|Full analysis set: The Full analysis set (FAS) comprised all patients who were randomized to study treatment. According to the intent to treat principle, patient was analyzed according to the treatment and strata they had been assigned to during the randomization procedure.|||Months||95% Confidence Interval|Median
2655151|NCT01628874|Secondary|Change in Heart Rate|Heart rate was measured at 5 points in time (pre-procedure, application of J-Tip, at LP needle insertion, while the needle is in place, and post-procedure) and was compared for significant differences|At 5 specific points during the procedure||||Beats per Minute||Standard Deviation|Mean
2655152|NCT01628874|Secondary|Number of Participants With Lumbar Puncture Success|The success of lumbar puncture was defined as obtaining Cerebrospinal fluid (CSF) on the first attempt and <1000 Red Blood Cells/millimeter cubed|Immediately following lumbar puncture||||Participants|||Count of Participants
2655153|NCT01628874|Primary|Pain Score|The pain score was assessed using the 5-point Neonatal Coding System (NFCS) on a scale of 0-5, with 0 indicating no pain and 5 the highest level of pain.|At time J-TIP is used||||score on a scale||Inter-Quartile Range|Median
2655154|NCT01628874|Primary|Pain Score|The pain score was assessed using the 5-point Neonatal Coding System (NFCS) on a scale of 0-5, with 0 indicating no pain and 5 the highest level of pain.|At Needle Insertion||||score on a scale||Inter-Quartile Range|Median
2655155|NCT01628874|Primary|Pain Score|The pain score was assessed using the 5-point Neonatal Coding System (NFCS) on a scale of 0-5, with 0 indicating no pain and 5 the highest level of pain.|Immediately Post-Procedure||||score on a scale||Inter-Quartile Range|Median
2655156|NCT01628848|Secondary|The Modified Hoehn & Yahr Severity of Illness|"Mean change (LOCF) from baseline in the Modified Hoehn & Yahr Severity of Illness at 12 weeks after dosing.~The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease without impairment of balance; 2.5, Mild bilateral disease with recovery on pull test; 3, Mild to moderate bilateral disease, some postural instability, physically independent 4, Severe disability, still able to walk or stand unassisted; and 5, Wheelchair bound or bedridden unless aided."|Baseline, 12 weeks after dosing|FAS, LOCF|||Percentage of participants|||Number
2655157|NCT01628848|Secondary|Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average Score of on State and Off State), UPDRS Part 3 Sum Score, and UPDRS Part 4 Sum Score.|"Mean change (LOCF) from baseline in total of UPDRS Part 1 sum score, UPDRS Part 2 sum score (average score of on state and off state), UPDRS Part 3 sum score, and UPDRS Part 4 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 1, 2, 3, and 4 assess 4, 13, 14, and 11 items respectively. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2655158|NCT01628848|Secondary|Total of UPDRS Part 2 Sum Score (Average Score of on State and Off State) and UPDRS Part 3 Sum Score|"Mean change (LOCF) from baseline in total of UPDRS Part 2 sum score (average score of on state and off state), and UPDRS Part 3 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items and Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2655159|NCT01628848|Secondary|UPDRS Part 4 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 4 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 4 assesses 11 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2655161|NCT01628848|Secondary|UPDRS Part 2 Sum Score (on State)|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state) at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2655162|NCT01628848|Secondary|Effective Rate in Off Time|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in off time at 12 weeks after dosing.|Baseline, 12 weeks after dosing.|FAS subjects with measurable off time data at baseline, LOCF|||Percentage of participants||95% Confidence Interval|Number
2655163|NCT01628848|Secondary|UPDRS Part 1 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 1 sum score at 12 weeks after dosing.~UPDRS sub-scale Part 1 assesses 4 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, 12 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2655164|NCT01628848|Secondary|Effective Rate in UPDRS Part 3 Sum Score|Effective rate (percentage of subjects with 20% or 30% decrease) (LOCF) in UPDRS Part 3 sum score at 12 weeks after dosing.|Baseline, 12 weeks after dosing|FAS, LOCF|||Percentage of participants||95% Confidence Interval|Number
2655165|NCT01628848|Secondary|Off Time|Mean change (LOCF) from baseline in off time at 12 weeks after dosing.|baseline, 12 weeks after dosing|FAS subjects with measurable off time data at baseline, LOCF|||Hours||Standard Deviation|Mean
2655166|NCT01628848|Secondary|UPDRS Part 2 Sum Score (Average Score of on State and Off State)|"Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average scores of on state and off state) at 12 weeks after dosing.~Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average score of on state and off state) at 12 weeks after dosing.~UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 12 weeks after dosing|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2655167|NCT01628848|Primary|Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score|"Mean change (LOCF) from baseline in UPDRS Part 3 sum score at 12 weeks after dosing.~UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|baseline, 12 weeks after dosing|Full analysis set (FAS), last observation carried forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
2655168|NCT01628718|Primary|Clinical Status of Participants as Measured by the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)|Proportion of patients recovered (meets Reliable Change Index (RCI) threshold and has change of at least 2SD from baseline to post-treatment), improved (meets positive RCI threshold), unchanged (does not meet RCI threshold) or deteriorated (meets negative RCI threshold) based on change in the CAPS-IV.|Pre-treatment (baseline), post-treatment (8-12 weeks)|Intent to treat|||Participants|||Count of Participants
2655169|NCT01628692|Secondary|Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.|From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)|All treated participants.|||Participants|||Number
2655170|NCT01628692|Secondary|Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) by rs12979860 Single Nucleotide Polymorphisms in the IL-28B Gene Categories|Participants were categorized into 3 genotypes based on single nucleotide polymorphisms in the IL28B gene. SVR12 was defined as hepatitis C virus (HCV) RNA levels below lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Baseline, post-treatment Week 12 (Follow-up period)|All treated participants. Here ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
2655171|NCT01628692|Secondary|Percentage of Participants With End of Treatment Response (EOTR)|EOTR were defined as hepatitis C virus (HCV) RNA levels <lower limit of quantitation, target not detected at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|End of treatment (Week 24)|All treated participants.|||Percentage of participants||80% Confidence Interval|Number
2655172|NCT01628692|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR were defined as hepatitis C virus (HCV) RNA levels to be <lower limit of quantitation, target not detected at both Week 4 and Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4 and Week 12|All treated participants.|||Percentage of participants||80% Confidence Interval|Number
2655173|NCT01628692|Primary|Percentage of Participants With Sustained Virologic Response Rate at Post-treatment Week 12 (SVR12)|SVR12 rate was defined as hepatitis C virus (HCV) RNA levels to be <lower limit of quantitation, target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Post Treatment Week 12 (Follow-up period)|All participants who were randomized and received at least 1 dose of active study therapy (daclatasvir, simeprevir, ribavirin).|||Percentage of participants||80% Confidence Interval|Number
2655174|NCT01628692|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as hepatitis C virus (HCV) RNA levels to be <lower limit of quantitation, target not detected at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 12|All treated participants.|||Percentage of participants||80% Confidence Interval|Number
2655175|NCT01628692|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) at Week 4|RVR was defined as hepatitis C virus (HCV) RNA levels to be <lower limit of quantitation, target not detected at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.|Week 4|All treated participants.|||Percentage of participants||80% Confidence Interval|Number
2655176|NCT01628614|Secondary|Percentage of Patients With an IOP Reduction ≥20% From Baseline|Percentage of patients with an IOP reduction ≥20% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 20% was evaluated in the eye with the highest pressure at the baseline visit.|Baseline, 14 Weeks|Evaluable Patients: all patients who met the study entry criteria|||Percentage of Patients|||Number
2655177|NCT01628614|Secondary|Percentage of Patients With an IOP Reduction ≥10% From Baseline|Percentage of patients with an IOP reduction ≥10% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 10% was evaluated in the eye with the highest pressure at the baseline visit.|Baseline, 14 Weeks|Evaluable Patients: all patients who met the study entry criteria|||Percentage of Patients|||Number
2655178|NCT01628614|Primary|Percentage of Patients With a Reduction in Intraocular Pressure (IOP) ≥ 5mmHg From Baseline|Percentage of patients with a reduction in IOP≥5 mmHg from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 5 mmHg was evaluated in the eye with the highest pressure at the baseline visit.|Baseline, 14 Weeks|Evaluable Patients: all patients who met the study entry criteria|||Millimeters of Mercury (mmHg)|||Number
2655179|NCT01628601|Secondary|Patients Continuing With GANfort® After 18 Weeks|Patients continuing with GANfort® after 18 weeks was assessed as Yes or No.|18 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
2655180|NCT01628601|Secondary|Physician Assessment of Adherence to GANfort®|"Physician Assessment of Adherence to GANfort® was assessed on a 3-point scale (better, equal, and worse). The number of patients assessed as better compliance are reported."|18 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
2655181|NCT01628601|Secondary|Patient Assessment of Tolerability Using a 4-Point Scale|Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|18 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
2655182|NCT01628601|Secondary|Physician Assessment of Tolerability Using a 4-Point Scale|Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|18 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
2655183|NCT01628601|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.|Baseline, 18 Weeks|All enrolled patients with complete data for this outcome measure|||Millimeters of Mercury (mmHg)||Inter-Quartile Range|Median
2655184|NCT01628588|Secondary|Patients Who Will Continue Use of Lumigan® After 14 Weeks|Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No.|14 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
2655185|NCT01628588|Secondary|Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks|Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No.|14 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
2655186|NCT01628588|Secondary|Physician Assessment of Tolerability Using a 4-Point Scale|Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|14 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
2655187|NCT01628588|Secondary|Patient Assessment of Tolerability Using a 4-Point Scale|Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.|14 Weeks|All enrolled patients with complete data for this outcome measure|||Participants|||Number
2655188|NCT01628588|Primary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.|Baseline, 14 Weeks|All enrolled patients with complete data for this outcome measure|||Millimeters of Mercury (mmHg)||Inter-Quartile Range|Median
2655189|NCT01628549|Secondary|The Dichotomized IGA Score at Weeks 1, 2, 4, 8, and 12|"The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4.~The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit."|Baseline to Final Visit (Up to Week 12)|Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population|||Participants|||Count of Participants
2655190|NCT01628549|Secondary|The Percent Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit||Baseline (Week 0) up to Week 12|Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population|||Percent change - noninflammatory lesions||Standard Deviation|Mean
2655191|NCT01628549|Secondary|The Percent Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit||Baseline (Week 0) up to Week 12|Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population|||Percent Change - Inflammatory Lesions||Standard Deviation|Mean
2655192|NCT01628549|Secondary|The Absolute Change From Baseline in the Noninflammatory Lesion Count at Weeks 1, 2, 4, 8, 12, and the Final Visit||Baseline (Week 0) up to Week 12|Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population|||Count of Noninflammatory Lesions||Standard Deviation|Mean
2655193|NCT01628549|Secondary|The Absolute Change From Baseline in the Inflammatory Lesion Count at Weeks 1, 2, 4, 8, 12 and the Final Visit||Baseline (Week 0) up to Week 12|Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population|||Count of Inflammatory Lesions||Standard Deviation|Mean
2655194|NCT01628549|Primary|The Dichotomized IGA (Investigator Global Assessment) Score at Final Visit|"The Investigator Global Assessment Scale (IGA) for Acne Vulgaris Score is a 5-point ordinal scale ranging from 0 to 4.~The dichotomized IGA score, where success was defined as at least a 2-grade decrease in the IGA score during the Final Visit as compared to the Baseline Visit."|Final Visit (Up to Week 12)|Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population|||Participants|||Count of Participants
2655195|NCT01628549|Primary|The Absolute Change From Baseline in the Inflammatory Lesion Count at the Final Visit||Baseline (Week 0) to Final Visit (Up to Week 12)|Of the 285 participants in the Safety Population, 284 received a post-Baseline efficacy assessment, to comprise the mITT (Modified Intent-to-Treat) Population.|||Number of Inflammatory Lesions||Standard Deviation|Mean
2655196|NCT01628523|Secondary|The Incidence of ARDS in Mechanically Ventilated Emergency Department Patients, and Risk Factors Associated With Progression to ARDS|Development of ARDS after admission to the hospital|1 month||||participants|||Number
2655197|NCT01628523|Primary|To Further Characterize ED Mechanical Ventilation|In a prospective cross-sectional study design, we will enroll all patients receiving mechanical ventilation in the ED over a one-month time frame.|1 month|Tidal volume used for the entire cohort|||mL||Inter-Quartile Range|Median
2655198|NCT01628510|Secondary|The Bayley Scales of Infant Development-3rd Edition (BSID-III)|"The BSID-III is the gold standard for assessing developmental outcome in childhood. Subscale composite scores for language, motor and cognition will be determined.~Language~--Scale Range (higher values represent a better outcome)~Minimum Score: 40~Maximum Score: 160~Motor~--Scale Range (higher values represent a better outcome)~Minimum Score: 40~Maximum Score: 160~Cognition --Scale Range (higher values represent a better outcome)~Minimum Score: 40~Maximum Score: 160"|1 year, 2 years|23 total participants completed Bayley Scales follow-up testing at 1 year; 7 total participants completed Bayley Scales follow-up testing at 2 years.|||units on a scale||Standard Deviation|Mean
2655199|NCT01628510|Primary|NICU Network Neurobehavioral Scale (NNNS)|The NNNS wasl used to assess neurobehavioral outcome near term equivalent (between 35 weeks and 41 weeks postmenstrual age). This tool consists of eliciting neonatal reflexes and observing behavior. From the assessment, 13 summary scores were determined for each of the following constructs: habituation (1-9), orientation (1-9), self regulation (1-9), tolerance of handling (0-1), hypertonia (0-10), hypotonia (0-10), asymmetry (0-16), lethargy (0-15), excitability (0-15), sub-optimal reflexes (0-15), arousal (1-9), quality of movement (1-9) and stress (0-1). Each summary score is analyzed for associations with subsequent developmental outcome. A higher score in each category indicates more of that construct. Specifically, for the summary score of asymmetry (the significant finding in this study), higher scores equal more asymmetry.|35 to 41 weeks (term equivalent); prior to NICU discharge||||Asymmetry Score (units on a scale)||Standard Deviation|Mean
2655200|NCT01628367|Secondary|Pink Esthetic Score|Pink esthetic score per Furhauser et.al. measured at study conclusion where based on seven variables: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture (Fig. 1). Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. Thus a maximum score of 14 is best, and 0 is the worst.|One year||||units on a scale||Standard Deviation|Mean
2655201|NCT01628367|Secondary|Change in Interproximal Bone Levels|Change of interproximal marginal bone loss (mean of mesial and distal sites)|One year||||millimeters||Standard Deviation|Mean
2655202|NCT01628367|Primary|Change in Thickness of Buccal Bone|Change of buccal bone volume over study duration|One year||||millimeters||Standard Deviation|Mean
2655203|NCT01628250|Secondary|Survival Rate|The follow up to the patients after the surgery to evaluate the oncological results of the technique|3 years after the surgery|||||||
2655204|NCT01628250|Primary|Histopathological Outcomes Obtained Through the Surgeries|number of lymph nodes retrieved|14 days after the surgery||||nodes||Standard Deviation|Mean
2655205|NCT01628198|Secondary|Anti-hypertensive Medications|The total number of anti-hypertensive medications at baseline, 6 months, and 12 months|Baseline, 6 months, 12 months|some participants withdrew from the study, some were lost to follow-up|||medications||Standard Deviation|Mean
2655206|NCT01628198|Secondary|Creatinine|Creatinine measures the level of the waste product in the body. The amount of creatinine in the blood depends partly on the amount of muscle tissue you have. Men generally have higher creatinine levels than women.Normal levels of creatinine in the blood are approximately 0.6 to 1.2 milligrams (mg) per deciliter (dL) in adult males and 0.5 to 1.1 milligrams per deciliter in adult females. High levels of creatinine indicates kidney impairment.|baseline, 6 months, 12 months|some participants withdrew from the study, others were lost to followup|||mg/dl||Standard Deviation|Mean
2655207|NCT01628198|Secondary|Blood Urea Nitrogen|A blood urea nitrogen (BUN) test measures the amount of nitrogen in blood that comes from the waste product urea. Urea is made when protein is broken down in the body. Urea is made in the liver and passed out in the urine.|baseline, 6 months, 12 months|some participants withdrew from the study, others were lost to followup|||mg/dL||Standard Deviation|Mean
2655208|NCT01628198|Secondary|Renal Artery Dimensions|Dimensions of renal artery, right and left|baseline and 12 months|some participants withdrew from the study, some were lost to follow up|||mm||Standard Deviation|Mean
2655209|NCT01628198|Secondary|Resistive Index|Renal artery blood flow as measured by Resistive Index. RI = (peak systolic velocity - end diastolic velocity ) / peak systolic velocity. the normal value is ~ 0.60, with 0.70 being around the upper limits of normal|Baseline and 12 months|Some participants withdrew from the study, others were lost to follow up|||index||Standard Deviation|Mean
2655210|NCT01628198|Secondary|Renal Aortic Ratio|Renal artery blood flow as measured by Renal Aortic Ratio (RAR) = Peak systolic Velocity renal artery / Peak Systolic Velocity Aorta. A >60% stenosis is reported when there is a >3.5:1 Renal to Aortic Ratio.|Baseline and 12 months|Some participants withdrew from the study, others were lost to follow up|||ratio||Standard Deviation|Mean
2655211|NCT01628198|Secondary|Office Diastolic BP|Different time points office diastolic blood pressure measurements|baseline, 6 month, 12 months|some participants withdrew from the study, and others were lost to follow up.|||mm Hg||Standard Deviation|Mean
2655212|NCT01628198|Secondary|Office Systolic BP|Different time points office systolic blood pressure measurements|baseline, 6 month, 12 months|some participants withdrew from the study, and others were lost to follow up.|||mm Hg||Standard Deviation|Mean
2655215|NCT01628159|Secondary|Number of Participants With Primary Patency Based on Alternative Peak Systolic Velocity Ratio (PSVR) Thresholds at 6, 12, and 24 Months Post Index Procedure|"Alternative Primary and Secondary Patency based on alternative definitions of Duplex Ultrasonography (DUS) Peak Systolic Velocity Ratio (PSVR) <2.0 and <3.0~Duplex Ultrasonography (DUS) Clinical Patency (DUS Peak Systolic Velocity Ratio (PSVR) <2.5 without prior Clinically Driven TLR)"|6, 12, and 24 months post index procedure|The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.|||Participants|||Count of Participants
2655216|NCT01628159|Secondary|Improvement From Baseline in Rutherford Classification (Index Limb) at 6, 12, and 24 Months Post Index Procedure|The endpoint summarizes the change in index-limb Rutherford Classification of participants from baseline through 24 months. Data is presented as shift from baseline Rutherford Classification data using the following categories: 1) Improvement, 2) Same, and 3) Worsened.|6, 12, and 24 months post index procedure|The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.|||Participants|||Count of Participants
2655217|NCT01628159|Secondary|Number of Participants With Freedom From Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Months Post Index Procedure||1, 6, 12, and 24 months post index procedure|The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.|||Participants|||Count of Participants
2655218|NCT01628159|Secondary|Change From Baseline of Index-limb Resting Ankle Brachial Index (ABI) at 6, 12, and 24 Months Post Index Procedure|Presented is a summary of the Mean change in resting Ankle Brachial Index (ABI) from baseline through 24 months post index procedure. The ABI is defined as a ratio of ankle to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs. A lower ABI number suggests more Peripheral Arterial Disease.|6, 12, and 24 months post index procedure|The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.|||Index||Standard Deviation|Mean
2655219|NCT01628159|Secondary|Number of Participants With Primary Patency of the Target at 6, 12, and 24 Months Post Index Procedure|Primary patency is defined as freedom from target lesion restenosis by core lab adjudication (DUS ≥ 2.5) and target lesion revascularization (TLR).|6, 12, and 24 months post index procedure|The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.|||Participants|||Count of Participants
2655220|NCT01628159|Secondary|Number of Participants With Technical and Procedural Success||At time of index procedure|The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.|||Participants|||Count of Participants
2655221|NCT01628159|Secondary|Number of Participants With Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 1, 6, 12, 24, 36, 48, and 60 Months Post Index Procedure (PPI)||1, 6, 12, 24, 36, 48, and 60 months post index procedure|The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.|||Participants|||Number
2655222|NCT01628159|Secondary|Number of Participants With Freedom From All-cause Death, Index Limb Amputation Above the Ankle and Target Vessel Revascularization (TVR) at 30 Days Post Index Procedure|This VIVA Safety Endpoint is defined as Freedom at 30 days from all-cause death, index limb amputation above the ankle and target vessel revascularization (TVR).|30 days post index procedure||||Participants|||Count of Participants
2655223|NCT01628159|Secondary|Number of Acute Device Success at Time of Index Procedure|In certain procedures, more than one device was use resulting in a higher number of devices (894) than participants (657) for this endpoint.|At time of Index Procedure||||Devices|Devices||Count of Units
2655224|NCT01628159|Secondary|Number of Patients With Freedom From All-Cause Perioperative (≤ 30 Day) Death and Freedom From Index Limb Amputation, Index Limb Re-Intervention, and Index-Limb-Related Death at 1, 6, 12, 24, 36, 48, and 60 Months Post Index Procedure|Composite of freedom from all-cause perioperative (≤ 30 day) death and freedom from the following at 1, 6, 12, 24, 36, 48, and 60 months: index limb amputation, index limb re-intervention, and index-limb-related death.|1, 6, 12, 24, 36, 48 and 60 months Post Index Procedure|The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.|||Participants|||Count of Participants
2655225|NCT01628159|Primary|Number of Unanticipated Device- or Drug- Related Adverse Events Through 60 Months Post Index Procedure||60 months Post Index Procedure||||Events|||Number
2655226|NCT01628120|Other Pre-specified|Percentage of Participants With Anti-Recombinant Human Erythropoietin (rhEPO) Antibodies|Percentage of participants with at least 1 positive anti-rhEPO antibodies were reported. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies.|Baseline, Week 48|Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, “n” signifies those participants who were evaluable at specified time points.|||Percentage of participants|||Number
2655227|NCT01628120|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Physical Examinations|Physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any clinically significant changes in physical status, as determined by the investigator.|Baseline up to Week 48|Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.|||Participants|||Number
2655228|NCT01628120|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG)|ECG parameters included: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in 12-lead ECGs were based on investigator's discretion.|Baseline up to Week 48|Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.|||Participants|||Number
2655229|NCT01628120|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests|Laboratory tests included: Hematology (hematocrit, hemoglobin, red blood cells count, reticulocytes, white blood cells count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular volume); Coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); Chemistry (blood urine nitrogen, creatinine, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, calcium, gamma-glutyl transpeptidase, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein); iron status (plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory tests were based on investigator's discretion.|Baseline up to Week 48|Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.|||Participants|||Number
2655230|NCT01628120|Other Pre-specified|Number of Participants Who Received Concomitant Medication||Week 1 up to Week 48|Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.|||Participants|||Number
2655231|NCT01628120|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Hemoglobin (Hb) Levels|Participants with clinically significant change from baseline in hemoglobin levels were upon investigator's discretion.|Baseline up to Week 48|Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.|||Participants|||Number
2655232|NCT01628120|Other Pre-specified|Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)||Week 1 up to Week 48|"Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
2655233|NCT01628120|Other Pre-specified|Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)||Week 1 up to Week 48|"Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
2655234|NCT01628120|Secondary|Percentage of Participants Who Received Blood Transfusions||Week 1 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value.|||Percentage of participants|||Number
2655235|NCT01628120|Secondary|Percentage of Participants With Hemoglobin Level Outside Target Range|Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported.|Week 1 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value.|||Percentage of participants|||Number
2655236|NCT01628120|Secondary|Mean Hematocrit Levels for Interval of 12 Weeks|Hematocrit is defined as the percentage of red blood cells in the blood.|Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||Percentage of red blood cells||Standard Deviation|Mean
2655237|NCT01628120|Secondary|Mean Hematocrit Levels: Over Week 1 to 48|Hematocrit is defined as the percentage of red blood cells in the blood.|Week 1 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value.|||Percentage of red blood cells||Standard Deviation|Mean
2655238|NCT01628120|Secondary|Mean Hemoglobin Levels for Interval of 12 Weeks||Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value. Here, 'n’ signifies those participants who were evaluable at specified time points.|||g/dL||Standard Deviation|Mean
2655239|NCT01628120|Secondary|Mean Hemoglobin Levels: Over Week 1 to 48||Week 1 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value.|||g/dL||Standard Deviation|Mean
2655240|NCT01628120|Secondary|Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks||Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value. Here, ‘n’ signifies those participants who were evaluable at specified time points.|||U/kg/week||Standard Deviation|Mean
2655241|NCT01628120|Secondary|Mean Weekly Dosage of Epoetin Hospira: Over Week 1 to 48||Week 1 up to Week 48|Full analysis set (FAS) included all enrolled participants and had at least 1 dose of Epoetin Hospira and had at least 1 Hb value.|||Unit per kilogram per week (U/kg/week)||Standard Deviation|Mean
2655242|NCT01628120|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 1 up to Week 48|Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.|||Percentage of participants|||Number
2655243|NCT01628120|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 37 up to Week 48|"Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
2655244|NCT01628120|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 25 up to Week 36|"Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
2655245|NCT01628120|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 13 up to Week 24|"Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
2655246|NCT01628120|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 1 up to Week 12|Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira.|||Percentage of participants|||Number
2655247|NCT01628120|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Up through 7 days after first dose of study drug (Week 1)|"Safety analysis set included all enrolled participants who received at least 1 dose of Epoetin Hospira. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
2655248|NCT01628107|Other Pre-specified|Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies|Percentage of participants with at least 1 positive anti-rhEPO antibody were reported. Radioimmunoprecipitation assay was used to determine the presence of anti-rhEPO antibodies.|Baseline, Week 48|Safety analysis set included all participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2655249|NCT01628107|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Physical Examinations|Physical examination included examination of the skin, eyes, ears, nose, throat, head, neck, thyroid, lungs, chest, abdomen, extremities, lymphatic, cardiovascular, musculoskeletal and neurological systems. Participants for any clinically significant changes in physical examination were based on the investigator's discretion.|Baseline up to Week 48|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Number
2655250|NCT01628107|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG)|ECG parameters included: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in 12-lead ECGs were based on investigator's discretion.|Baseline up to Week 48|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Number
2655251|NCT01628107|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests|Laboratory tests included: Hematology (hematocrit, hemoglobin, red blood cells count, reticulocytes, white blood cells count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular volume); Coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); Chemistry (blood urine nitrogen, creatinine, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, calcium, gamma-glutyl transpeptidase, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein); iron status (plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory tests were based on investigator's discretion.|Baseline up to Week 48|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Number
2655252|NCT01628107|Other Pre-specified|Number of Participants Who Received Concomitant Medication||Week 1 up to Week 48|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Number
2655253|NCT01628107|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Hemoglobin Levels|Participants with clinically significant change from baseline in hemoglobin levels were upon investigator's discretion.|Baseline up to Week 48|Safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Number
2655254|NCT01628107|Other Pre-specified|Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)||Week 1 up to Week 48|"Safety analysis set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
2655255|NCT01628107|Other Pre-specified|Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)||Week 1 up to Week 48|"Safety analysis set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
2655256|NCT01628107|Secondary|Percentage of Participants Who Received Blood Transfusions||Week 1 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value.|||Percentage of participants|||Number
2655257|NCT01628107|Secondary|Percentage of Participants With Hemoglobin Level Outside the Target Range|Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported.|Week 1 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value.|||Percentage of participants|||Number
2655258|NCT01628107|Secondary|Mean Hematocrit Levels for Interval of 12 Weeks|Hematocrit is defined as the percentage of red blood cells in the blood.|Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48|FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value.|||Percentage of red blood cells||Standard Deviation|Mean
2655259|NCT01628107|Secondary|Mean Hematocrit Levels: Over Week 1 to 48|Hematocrit is defined as the percentage of red blood cells in the blood.|Week 1 up to Week 48|"FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of red blood cells||Standard Deviation|Mean
2655263|NCT01628107|Secondary|Mean Weekly Dosage of Epoetin Hospira : Over Week 1 to 48||Week 1 up to Week 48|"Full analysis set (FAS) included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Unit per kilogram per week (U/kg/week)||Standard Deviation|Mean
2655264|NCT01628107|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 1 up to Week 48|Safety analysis set included all participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2655265|NCT01628107|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 37 up to Week 48|"Safety analysis set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
2655266|NCT01628107|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 25 up to Week 36|"Safety analysis set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
2655267|NCT01628107|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 13 up to Week 24|"Safety analysis set included all participants who received at least 1 dose of study drug. Here, ''number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
2655268|NCT01628107|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Week 1 up to Week 12|Safety analysis set included all participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2655269|NCT01628107|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.|Up through 7 days after first dose of study drug (Week 1)|"Safety analysis set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||Percentage of participants|||Number
2655270|NCT01628042|Primary|Apparent Total Body Clearance (CL/F) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine CL/F after a single oral dose of vibegron 100 mg.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||L/hr||95% Confidence Interval|Geometric Mean
2655271|NCT01628042|Primary|Maximum Plasma Concentration (Cmax) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine Cmax after a single oral dose of vibegron 100 mg.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|PP population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||nM||95% Confidence Interval|Geometric Mean
2655272|NCT01628042|Primary|Area Under the Concentration-time Curve From 0 to Infinity (AUC0-∞) After a Single Oral Dose of Vibegron 100 mg|Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine AUC0-∞ after a single oral dose of vibegron 100 mg.|Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose|Per Protocol (PP) population, which included participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment, according to the underlying scientific model.|||nM•hr||95% Confidence Interval|Geometric Mean
2655273|NCT01628016|Secondary|Anxiety and Rumination Symptoms Measured by State-Trait Anxiety Inventory-Trait(STAI-T) and Rumination Response Style（RRS）|"State-Trait Anxiety Inventory-Trait (STAI-T) measures the anxiety symptoms of the individuals who often feel.It consists of 20 items and each question provides for a response of 1 to 4. A 1 response means the anxiety symptom is not present; a 2 means the symptom is present but a little, a 3 means the symptom is usually present, and a 4 means the symptom lasts all the time. The total STAI-T score is the sum of the individual items; total STAI-T scores can range from 20 to 80. The higher values represent a worse outcome.~The RRS measures ruminative responses to depressed mood. The content of the items is related to depressive cognitions and their possible causes and consequences. The scale consists of 21items and each question provides for a response of 1 to 4. The total RRS scores can range from 21 to 84. The higher values represent a worse outcome."|From baseline to post-training, 2-, 4-, 8-week, 3- , 7-month follow-ups after training||||units on a scale||Standard Deviation|Mean
2657198|NCT01607853|Secondary|Change From Baseline in Erythema at Day 4.|Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to day 4||||units on a scale||Standard Deviation|Mean
2655274|NCT01628016|Primary|Depressive Symptoms Measured by Beck Depression Inventory-II|Beck Depression Inventory-II(BDI-II) contains 21 items and rates the depressive symptoms for the past two weeks. Each question provides for a response of 0 to 3. A zero response means the depressive symptom is not present; a 1 means the symptom is present, a 2 means the symptom is moderate, and a 3 means the symptom is severe. The total BDI-II score is the sum of the individual items; total BDI-II scores can range from 0 to 63. Cutoff points developed by Beck, Steer, & Brown (1997) for the total BDI-II are: 0 to 13, nondepressed; 14 to 19, mild depression; 20 to 28, moderate depression; 29 or more, severe depression.|From the baseline to posttraining, 2-, 4-, 8-week, 3-, 7-month follow-ups after training||||units on a scale||Standard Deviation|Mean
2655275|NCT01627899|Secondary|Change in 30 Day Mean Glucose Comparing First Month to Last Month After 24 Weeks||24 weeks|Study terminated early by sponsor, no analysis completed.||||||
2655276|NCT01627899|Secondary|Change in Proportion of Subjects With A1C Less Than or Equal to 7.0% at Week 24||24 weeks|Study terminated early by sponsor, no analysis completed.||||||
2655277|NCT01627899|Secondary|Change in FPG From Baseline to 24 Weeks and Over Time|Change in Fasting Plasma Glucose (FPG) from baseline to 24 weeks and over time|24 weeks and over time|Study terminated early by sponsor, no analysis completed.||||||
2655278|NCT01627899|Secondary|Change in A1C From Baseline to Week 12|Change in A1C from baseline to week 12|12 weeks|Study terminated early by sponsor, no analysis completed.||||||
2655279|NCT01627899|Primary|Change in A1C From Baseline to Week 24|Change in A1C from baseline to week 24|24 weeks|Study terminated early by sponsor, no analysis completed.||||||
2655280|NCT01627860|Secondary|Dosage Administration of Topamax During Month 4||Month 4|Participants who have received study medication during month 4.|||mg||Standard Deviation|Mean
2655281|NCT01627860|Secondary|Seizure Frequency: Percent Change of Seizure Frequency by the ANCOVA Model During the Month 4|Seizure frequency (seizure count/month) was calculated based on the number of seizure within a month. The mean seizure frequency analyzed by the ANCOVA model at each period.|Baseline (4 weeks retrospective assessment prior to start of titration period) to Month 4|Intent-To-Treat population: All randomized participants who received at least one dose of study medication.|||Percent change||Standard Deviation|Mean
2655282|NCT01627860|Primary|Seizure Free Rate: Percentage of Participants Who Did Not Have Any Seizure Episode Within the Last Month of the Maintenance Period (ie, Month 4).||Month 4|Intent-To-Treat population: All randomized participants who received at least one dose of study medication.|||Percentage of participants|||Number
2655283|NCT01627782|Secondary|Elimination Half-Life (t1/2)|The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||hour||Standard Deviation|Mean
2655284|NCT01627782|Secondary|Volume of Distribution at Steady-State (Vss) of Ketamine|The Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of ketamine at steady state.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||liter||Standard Deviation|Mean
2655285|NCT01627782|Secondary|Total Systemic Clearance (CL) of Ketamine|The CL is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||liter per hour||Standard Deviation|Mean
2655286|NCT01627782|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])|The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC (last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||hour*nanogram per milliliter||Standard Deviation|Mean
2655287|NCT01627782|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC[0-last])|The AUC(0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||hour*nanogram per milliliter||Standard Deviation|Mean
2655376|NCT01626989|Secondary|Central Apnea Index(CAI)|Central Apnea Index(CAI) is the number of central apneas divided by the number of hours of sleep.|Baseline, and 2 nights (1 night for each intervention)|8 participants had missing or unscorable data, therefore they are not included in the analysis. 8 participants had missing or unscorable data, therefore they are not included in the analysis.|||events per hour||Standard Deviation|Mean
2655288|NCT01627782|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ketamine|The Tmax is defined as actual sampling time to reach maximum observed drug concentration.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||Hour||Full Range|Median
2655289|NCT01627782|Secondary|Maximum Observed Plasma Concentration (Cmax) of Ketamine|The Cmax is the maximum observed plasma concentration of drug.|Pre-infusion, 20, 40 (End of the Infusion), 45, 50, 60, 90, 120, 180, 240 and 360 minutes post-infusion on Day 1 and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||nanogram per milliliter (ng/ml)||Standard Deviation|Mean
2655290|NCT01627782|Secondary|Patient Global Impression-Change (PGI-C) Score at Endpoint of Double Blind Phase|The PGI-C is a 7-point scale that required the subject to assess how much their illness had improved or worsened relative to a baseline state at the beginning of the intervention. The response options were: very much improved; much improved; improved (just enough to make a difference); no change; worse (just enough to make a difference); much worse; or very much worse. The scale is rated as, 1=very much improved and 7=very much worse.|Endpoint (Day 29)|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a scale||Full Range|Median
2655291|NCT01627782|Secondary|Change in Patient Global Impression-Severity (PGI-S) Score From Baseline to Endpoint (Day 29)|The PGI-S is an 11-point (0 to 10) scale that required the participant to rate the severity of their illness at the time of assessment, relative to the participants past experience. Considering their total experience, the participant was to assess the severity of their depression illness at the time of rating as none, mild, moderate or severe. The scale is rated as, 0=very well and 10=very poor.|Baseline (Day 1) and Endpoint (Day 29)|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||Units on a scale||Full Range|Median
2655292|NCT01627782|Secondary|Clinical Global Impression of Improvement (CGI-I) Score at Endpoint of Double Blind Phase|The CGI-I is a 7-point scale that was used to assess how much the participants illness was improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 0= not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Endpoint (Day 29)|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a scale||Full Range|Median
2655293|NCT01627782|Secondary|Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline to Endpoint (Day 29)|The CGI-S was used to rate the severity of the participants illness at the time of assessment, relative to the clinician's past experience with participants who had the same diagnosis and improvement with treatment. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to: 0= not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants.|Baseline (Day 1) and Endpoint (Day 29)|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||Units on a scale||Full Range|Median
2655294|NCT01627782|Secondary|Number of Sustained Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Sustained response on Day 15 was defined as achieving an onset of antidepressant response within the first week that is maintained to the end of study Day 15. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Participants|||Number
2655295|NCT01627782|Secondary|Number of Remitters Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Participants who had a MADRS total score of less than or equal to (<=) 10 were considered remitters. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Day 15 and Day 29|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||Participants|||Number
2655388|NCT01626690|Secondary|Incidence of Perioperative Cardiac Events.|Incidence of perioperative arrhythmias or myocardial ischemia.|The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).||||Patients|||Number
2657217|NCT01607645|Secondary|CRi Defined as Meeting All Criteria for a Morphologic CR But ANC Remains Less Than 1,000/μL and/or Platelet Count Less Than 100,000/μL||Assessed for up to 5 years||||Participants|||Count of Participants
2655296|NCT01627782|Secondary|Number of Responders Based on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|Participants with a reduction in the MADRS total score of greater than or equal to (>=) 50 percent from baseline were defined as responders. The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Day 15 and Day 29|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||Participants|||Number
2655297|NCT01627782|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 29|The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Baseline (Day 1) and Day 29|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||Units on a scale||Standard Deviation|Mean
2655298|NCT01627782|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Day 15|The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe condition.|Baseline (Day 1) and Day 15|An intent-to-treat (ITT) analysis set is defined as all participants who receive at least 1 dose of study drug and have both Day 1 (baseline) and at least 1 post-baseline MADRS total score. Here,“N”(Number of Participants Analyzed) and “n” signifies those participants who were evaluable for this outcome measure and at given time point, respectively|||Units on a scale||Standard Deviation|Mean
2655299|NCT01627691|Primary|Primary Safety Endpoint: All-cause Mortality at 30 Days Post Implant Procedure|Mortality at 30 days from all patients enrolled in the study (ITT population): the proportion of patients who experience an event through 30 days post-procedure out of the patients who have either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days post-procedure|30 days|Mortality at 30 days from all patients enrolled in the study (ITT population): the proportion of patients who experience an event through 30 days post-procedure out of the patients who have either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days post-procedure|||Participants|||Count of Participants
2655300|NCT01627691|Primary|Primary Device Performance Endpoint: Mean Aortic Valve Pressure Gradient at 30 Days Post Implant Procedure|Mean aortic valve pressure gradient at 30 days post implant procedure as measured by echocardiography and assessed by an independent core laboratory.|30 days|As specified, this endpoint was evaluated using data from the first 120 patients enrolled in the study|||mmHG||Standard Deviation|Mean
2655301|NCT01627561|Secondary|Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion|"Measles/Rubella-like rash: presence of macules, discoloured small patches or spots of the skin, neither elevated nor depressed below the skin's surface and/or papules, raised bumps on the skin usually below (<) 1 cm in diameter.~Parotid/salivary gland swelling: swelling/tenderness in the mandibular/submandibular region.~Suspected signs of meningism including febrile convulsions: febrile convulsions or any other neurological signs or symptoms indicative of meningism.~Any = occurrence of any solicited symptom regardless of their intensity grade or relationship to vaccination. Any fever = axillary temperature equal to or above (≥) 37.5°C. Grade 3 AE = AE which prevented normal, everyday activities. Grade 3 measles/rubella-like rash = more than 150 lesions. Grade 3 parotid gland swelling = swelling with accompanying general symptoms. Grade 3 fever = axillary temperature above (>) 39.0°C. Related = any symptom assessed by the investigator as causally related to the vaccination."|During the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0|The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.|||Participants|||Count of Participants
2655302|NCT01627561|Secondary|Percentage of Subjects Completing the Vaccination Schedule in Both Groups|The percentage of subjects who received the specified total number of doses (dose 1, dose 2, any dose) is reported.|From Day 0 up to Month 6 (i.e. from first vaccination at Day 0 up to the second vaccination at Month 6)|The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.|||Percentage of subjects|||Number
2655303|NCT01627561|Secondary|Number of Subjects Reporting the Intake of Concomitant Medication During the 30-day Period Following the Vaccination at Month 6|Concomitant medication taken at least once during the 30-day period (i.e. from the day of vaccination up to 29 subsequent days) following the vaccination at Month 6 included: any type of medicines, antipyretics, prophylactic antipyretics and antibiotics.|During the 30-day period (i.e. from the day of vaccination up to 29 subsequent days) following the vaccination at Month 6|The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available. Out of the 74 subjects present in the initial Priorix + Infanrix Group, 3 did not receive the second vaccination and were hence excluded from this analysis.|||Participants|||Count of Participants
2655315|NCT01627561|Secondary|Anti-measles Antibody Concentrations|Anti-measles antibody concentrations were measured by ELISA, expressed as GMCs, in mIU/mL. The cut-off of the assay was an anti-measles antibody concentration ≥ 150 mIU/mL.|At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Day 42.|||mIU/mL||95% Confidence Interval|Geometric Mean
2655304|NCT01627561|Secondary|Number of Subjects Reporting the Intake of Concomitant Medication During the 43-day Period Following the Vaccination at Day 0|Concomitant medication taken at least once during the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0 included: any type of medicines, antipyretics, prophylactic antipyretics and antibiotics.|During the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0|The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.|||Participants|||Count of Participants
2655305|NCT01627561|Secondary|Number of Subjects With AEs/SAEs Leading to Withdrawal Throughout the Study Period|The number of subjects with AEs and SAEs leading to premature discontinuation of study was assessed.|Throughout the study period (i.e from Day 0 up to Month 12 for Priorix + Infanrix Group and from Day 0 up to Month 36 for Cervarix Group)|The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.|||Participants|||Count of Participants
2655306|NCT01627561|Secondary|Number of Subjects With SAEs Related to the Investigational Products or Any Fatal SAE|SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|Throughout the study period (i.e. from Day 0 up to Month 12 for Priorix + Infanrix Group and from Day 0 up to Month 36 for Cervarix Group)|The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.|||Participants|||Count of Participants
2655307|NCT01627561|Secondary|Number of Subjects With SAEs From Day 0 up to Month 12|SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 12 (i.e. from first vaccination at Day 0 up to 6 months after the second vaccination at Month 6)|The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.|||Participants|||Count of Participants
2655308|NCT01627561|Secondary|Number of Subjects With MSCs From Day 0 up to Month 12|MSCs were defined as AEs prompting emergency room or physician visits that were not related to common diseases or were not routine visits for physical examination or vaccination and as SAEs that were not related to common diseases. Common diseases included: upper respiratory tract infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.|From Day 0 up to Month 12 (i.e. from first vaccination at Day 0 up to 6 months after the second vaccination at Month 6)|The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.|||Participants|||Count of Participants
2655309|NCT01627561|Secondary|Number of Subjects With pIMDs From Day 0 up to Month 12|pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not have an autoimmune aetiology.|From Day 0 up to Month 12 (i.e. from first vaccination at Day 0 up to 6 months after the second vaccination at Month 6)|The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.|||Participants|||Count of Participants
2655310|NCT01627561|Secondary|Number of Seroprotected Subjects Against Diphtheria and Tetanus Antigens|"A seroprotected subject against diphtheria antigen was defined as a subject with an anti-diphtheria (anti-D) antibody concentration ≥ the cut-off of 0.1 IU/mL, as measured by ELISA.~A seroprotected subject against tetanus antigen was defined as a subject with an anti-tetanus (anti-T) antibody concentration ≥ the cut-off of 0.1 IU/mL, as measured by ELISA."|At Month 7 (i.e. 30 days after the vaccination at Month 6)|The analysis was performed on the ATP cohort for immunogenicity at Month 7, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Month 7.|||Participants|||Count of Participants
2655311|NCT01627561|Secondary|Anti-rubella Antibody Concentrations|Anti-rubella antibody concentrations were measured by ELISA, expressed as GMCs, in IU/mL. The cut-off of the assay was an anti-rubella antibody concentration ≥ 4 IU/mL.|At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Day 42.|||IU/mL||95% Confidence Interval|Geometric Mean
2655312|NCT01627561|Secondary|Number of Seropositive Subjects for Rubella Antigen|A seropositive subject was defined as a subject whose anti-rubella antibody titer was ≥ 4 IU/mL, as assessed by ELISA.|At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Day 42.|||Participants|||Count of Participants
2655313|NCT01627561|Secondary|Anti-mumps Antibody Concentrations|Anti-mumps antibody concentrations were measured by ELISA, expressed as GMCs, in U/mL. The cut-off of the assay was an anti-mumps antibody concentration ≥ 231 U/mL.|At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Day 42.|||U/mL||95% Confidence Interval|Geometric Mean
2655314|NCT01627561|Secondary|Number of Seropositive Subjects for Mumps Antigen|A seropositive subject was defined as a subject whose anti-mumps antibody titer was equal to or above (≥) 231 U/mL, as assessed by ELISA.|At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Day 42.|||Participants|||Count of Participants
2655316|NCT01627561|Secondary|Number of Seropositive Subjects for Measles Antigen|A seropositive subject was defined as a subject whose anti-measles antibody titer was equal to or above (≥) 150 milli-International Units per milliliter (mIU/mL), as assessed by ELISA.|At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)|The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Day 42.|||Participants|||Count of Participants
2655317|NCT01627561|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group)|Antibody concentrations were assessed by ELISA and expressed as GMCs in EU/mL. Note: Month 7 data are also reported in the Primary outcome measure.|At Month 7, Month 12 (for both groups) and at Month 18, Month 24 and Month 36 (only for Cervarix Group)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects for whom data concerning immunogenicity outcome measures were available at the specified time point. Priorix+Infanrix Group data were only tabulated for the time points up to Month 12, since the follow-up phase for this group ended at Month 12.|||EU/mL||95% Confidence Interval|Geometric Mean
2655318|NCT01627561|Secondary|Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group)|Seroconversion was defined as a titer greater than or equal to the cut-off value in the serum of seronegative subjects, defined as subjects who had an antibody titer below the cut-off value before vaccination. Titers were measured by ELISA and the cut-offs were 19 EU/mL for HPV-16 and 18 EU/mL for HPV-18. Note: Month 7 data are also reported in the Primary outcome measure.|At Month 7, Month 12 (for both groups) and at Month 18, Month 24 and Month 36 (only for Cervarix Group)|The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects for whom data concerning immunogenicity outcome measures were available at the specified time point. Priorix+Infanrix Group data were only tabulated for the time points up to Month 12, since the follow-up phase for this group ended at Month 12.|||Participants|||Count of Participants
2655319|NCT01627561|Primary|Anti-HPV-16/18 Antibody Concentrations at Month 7|Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EU/mL.|At Month 7 (i.e. 30 days after the vaccination at Month 6)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity at Month 7, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at the specified time point.|||EU/mL||95% Confidence Interval|Geometric Mean
2655320|NCT01627561|Primary|Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7|Seroconversion was defined as a titer greater than or equal to the cut-off value in the serum of seronegative subjects, defined as subjects who had an antibody titer below the cut-off value before vaccination. Titers were measured by Enzyme Linked Immunosorbent Assay (ELISA) and the cut-offs were 19 ELISA Units per milliliter (EU/mL) for HPV-16 and 18 EU/mL for HPV-18.|At Month 7 (i.e. 30 days after the vaccination at Month 6)|The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity at Month 7, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at the specified time point.|||Participants|||Count of Participants
2655321|NCT01627561|Primary|Number of Subjects With Medically Significant Conditions (MSCs) From Day 0 up to Month 7|MSCs were defined as AEs prompting emergency room or physician visits that were not related to common diseases or were not routine visits for physical examination or vaccination and as SAEs that were not related to common diseases. Common diseases included: upper respiratory tract infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.|From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6)|The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.|||Participants|||Count of Participants
2655322|NCT01627561|Primary|Number of Subjects With Potential Immune-mediated Diseases (pIMDs) From Day 0 up to Month 7|pIMDs were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not have an autoimmune aetiology.|From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6)|The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.|||Participants|||Count of Participants
2655323|NCT01627561|Primary|Number of Subjects With AEs and SAEs Leading to Withdrawal From Day 0 up to Month 7|The number of subjects with AEs and SAEs leading to premature discontinuation of the study was assessed.|From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6)|The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.|||Participants|||Count of Participants
2655324|NCT01627561|Primary|Number of Subjects With Serious Adverse Events (SAEs) From Day 0 up to Month 7|SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6)|The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.|||Participants|||Count of Participants
2655331|NCT01627340|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|During the entire study period (Month 0 - Month 7)|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration.|||Participants|||Count of Participants
2655325|NCT01627561|Primary|Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges|The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological (basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes [white blood cells] = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA). Abnormal laboratory values at Month 7 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) [e.g. ALAT Below (baseline) - Within (Month 7) = ALAT with below normal value at baseline and within normal values at Month 7].|At Month 7 (i.e. 30 days after the vaccination at Month 6)|The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available at the specified time point.|||Participants|||Count of Participants
2655326|NCT01627561|Primary|Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges|"The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological (basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes [white blood cells] = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA).~Abnormal laboratory values at Day 42 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) [e.g. ALAT Below (baseline) - Within (Day 42) = ALAT with below normal value at baseline and within normal values at Day 42]."|At Day 42 (i.e. 42 days after the vaccination at Day 0)|The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available at the specified time point.|||Participants|||Count of Participants
2655327|NCT01627561|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited AEs Reported During the 30-day Period Following the Vaccination at Month 6|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related AE = AE assessed by the investigator as causally related to the study vaccination.|During the 30-day period (i.e. from the day of vaccination up to 29 subsequent days) following the vaccination at Month 6|The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available. Out of the 74 subjects present in the initial Priorix + Infanrix Group, 3 did not receive the second vaccination and were hence excluded from this analysis.|||Participants|||Count of Participants
2655328|NCT01627561|Primary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Reported During the 43-day Period Following the Vaccination at Day 0|An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related AE = AE assessed by the investigator as causally related to the study vaccination.|During the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0|The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.|||Participants|||Count of Participants
2655329|NCT01627561|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia (only in joints which were distal from the injection site), drowsiness, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, irritability/fussiness, loss of appetite, myalgia, rash (not urticaria, not measels/rubella-like rash), urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Grade 3 irritability/fussiness = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = did not eat at all. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the 7-day follow-up period (i.e. from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses|The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study, who had their symptom sheet filled in and for whom data were available.|||Participants|||Count of Participants
2655330|NCT01627561|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.|During the 7-day follow-up period (i.e. from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses|The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study, who had their symptom sheet filled in and for whom data were available.|||Participants|||Count of Participants
2655373|NCT01626989|Secondary|Sleep Onset Latency (SOL)|Sleep Onset Latency (SOL) is the amount of time it takes to fall asleep after the lights have been turned off.|Baseline, and 2 nights (1 night for each intervention)|8 participants had missing or unscorable data, therefore they are not included in the analysis.|||minutes||Standard Deviation|Mean
2655332|NCT01627340|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration.|||Participants|||Count of Participants
2655333|NCT01627340|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Any fever = oral temperature greater than or equal to (≥) 37.5 degrees Celsius (°C)|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration and had symptom sheet completed.|||Participants|||Count of Participants
2655334|NCT01627340|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity grade.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on Total Vaccinated cohort, which included all subjects who received at least one study vaccine administration and had symptom sheet completed.|||Participants|||Count of Participants
2655335|NCT01627340|Secondary|Anti-HBs Antibody Concentration|Concentrations were given as geometric mean concentration (GMC) and expressed as mIU/mL|At one month after the third dose of primary vaccination (Month 7)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received all 3 doses of the EngerixTM-B vaccine, for whom post-vaccination immunogenicity results were available and for those in the Control Group, a suitable match was available in the Diabetic Group.|||mIU/mL||95% Confidence Interval|Geometric Mean
2655336|NCT01627340|Primary|Number of Subjects Seroprotected for Anti- Hepatitis B Surface Antigen (Anti-HBs) Antibodies|A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL).|At one month after the third dose of primary vaccination (Month 7)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received all 3 doses of the EngerixTM-B vaccine, for whom post-vaccination immunogenicity results were available and for those in the Control Group, a suitable match was available in the Diabetic Group.|||Participants|||Count of Participants
2655337|NCT01627327|Secondary|Change From Baseline in Trough FEV1 at Treatment Day 84|Pulmonary function was measured by FEV1. Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 84. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an ANCOVA model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.|Baseline and Day 84|ITT Population. Only participants with data available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
2655338|NCT01627327|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 minutes (min), 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose. Time to onset was analyzed using a log-rank test, stratified by exacerbation history and reversibility stratum.|Baseline and Day 1|ITT Population. Only participants with data available at the indicated time point were assessed.|||Minutes||Full Range|Median
2655339|NCT01627327|Primary|Change From Baseline Trough in 24-hour Weighted Mean FEV1 on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30 minutes and 1, 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline (BL) was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication. Only participants with data available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
2655340|NCT01627288|Secondary|Number of Participants With Late Dose Limiting Toxicities (DLT)|Late DLTs will be defined at grade 3-4 GI or GU toxicity with onset after 6 weeks of treatment.|3 years following treatment||||Participants|||Count of Participants
2655341|NCT01627288|Secondary|Number of Participants With Acute Dose Limiting Toxicities (DLT)|Acute DLT will be defined based on the side effects inherent from radiation therapy for gynecologic cancers, including effects on bowel, bladder, and skin.Since integrated radiation dose escalation is unlikely to substantially affect the hematopoietic system, only non-hematologic, grade 3-4, acute toxicity will be considered the primary dose-limiting toxicity (acute DLT). Dose limiting toxicity will include any of the following during treatment or within 6 weeks of completion: Acute Grade 3-4 enteritis or proctitis, Acute Grade 3-4 bladder toxicity, Acute Grade 4 dermatologic toxicity.|6 weeks following treatment||||Participants|||Count of Participants
2655342|NCT01627288|Secondary|Overall Survival (OS)||3 years after treatment||||years||Standard Deviation|Mean
2655343|NCT01627288|Secondary|Disease Free Survival (DFS)||3 years after treatment||||years||Standard Deviation|Mean
2655344|NCT01627288|Secondary|Time to Distant Recurrence (TTDR)||3 years after treatment||||years||Standard Deviation|Mean
2655345|NCT01627288|Secondary|Time to Local-regional Control With Integrated Boost Radiation Therapy (TTLR)|Local-regional control is defined as local control without any nodal recurrence.|3 years following treatment||||years||Standard Deviation|Mean
2655346|NCT01627288|Primary|Maximum Tolerated Dose of Integrated Boost Radiation Therapy, Administered With IMRT Technique With Concurrent Chemotherapy (Cisplatin).|Concurrent radiation therapy and chemotherapy is the standard of care for node positive cervical cancer. While there are several acceptable means to boost the disease in the low pelvis (i.e. brachytherapy, IMRT, or external beam), there is limited research into boosting gross disease in the pelvis or para-aortic region. This protocol is designed to determine the maximum tolerated dose of treating tumor bearing regions within the abdomen and pelvis, using an integrated boost technique and concurrent chemotherapy.|During RT to 6 weeks post RT||||Gray (Gy)|||Number
2655347|NCT01627249|Secondary|Eyes Receiving 1 or More Alternative Treatments for DME Other Than Laser||Baseline to 1-year||||Eyes|||Number
2655348|NCT01627249|Secondary|Total Number of Laser Treatments|Only includes participants that completed the 1 year visit.|between 24 weeks and 1 year||||participants|||Number
2655349|NCT01627249|Secondary|Total Number of Injections Prior to 1 Year|Only includes participants that completed the 1 year visit|Baseline to 1-year|Seven study eyes received 1 injection and 2 eyes received 2 injections of 0.5 mg of ranibizumab prior to the FDA approving a 0.3 mg dosage of ranibizumab for diabetic macular edema treatment.|||Injections||Standard Deviation|Mean
2655350|NCT01627249|Secondary|Overall Change in Retinal Volume|Baseline volume values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 459 scans. One-year volume values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 472 scans. When calculating change in volume, measurements taken on the same machine at both visits were not converted, because the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in volume was calculated after converting either the baseline and/or follow-up value from Spectralis or Cirrus to a Stratus equivalent value in 17 eyes.|Baseline to 1-year|In addition to participants missing the 1-year visit, 46 in the aflibercept group, 53 in the bevacizumab group, and 44 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.|||mm^3||Standard Deviation|Mean
2655351|NCT01627249|Secondary|Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score 78-69|"All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center.~Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes."|baseline to 1-year|In addition to participants missing the 1-year visit, 3 in the aflibercept group, 3 in the bevacizumab group, and 5 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.|||microns||Standard Deviation|Mean
2655352|NCT01627249|Secondary|Change in Optical Coherence Tomography Central Subfield Thickness: Baseline Visual Acuity Letter Score <69|"All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center.~Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes."|baseline to 1-year|In addition to participants missing the 1-year visit, 3 in the aflibercept group, 3 in the bevacizumab group, and 5 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.|||microns||Standard Deviation|Mean
2655353|NCT01627249|Primary|Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score 78-69|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|Baseline to 1-year|Visual acuity change truncated to +/- 3SD (-22 and +44) to minimize the effects of outliers for 6 eyes in the aflibercept group (4 on the positive end, 2 on the negative end) and 2 eyes in the bevacizumab group (both on the negative end).|||units on a scale||Standard Deviation|Mean
2655354|NCT01627249|Primary|Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|Baseline to 1-year|Visual acuity change truncated to +/- 3SD (-22 and +44) to minimize the effects of outliers for 6 eyes in the aflibercept group (4 on the positive end, 2 on the negative end) and 2 eyes in the bevacizumab group (both on the negative end).|||units on a scale||Standard Deviation|Mean
2655374|NCT01626989|Secondary|Mixed Apnea Index (MAI)|Mixed Apnea Index (MAI) is the number of combination of central and obstructive apneas divided by the number of hours of sleep.|Baseline, and 2 nights (1 night for each intervention)|8 participants had missing or unscorable data, therefore they are not included in the analysis.|||events per hour||Standard Deviation|Mean
2655375|NCT01626989|Secondary|Obstructive Apnea Index (OAI)|Obstructive Ap8 participants had missing or unscorable data, therefore they are not included in the analysis. nea Index (OAI) is the number of obstructive apneas divided by the number of hours of sleep.|Baseline, and 2 nights (1 night for each intervention)|8 participants had missing or unscorable data, therefore they are not included in the analysis.|||events per hour||Standard Deviation|Mean
2655355|NCT01627249|Secondary|Overall Change in Optical Coherence Tomography Central Subfield Thickness|"All baseline and 1-year optical coherence tomography (OCT) scans were graded by Duke Reading Center. In addition, a random sample of OCT images from other visits and images for which the investigator believed central grading was needed also were graded by Duke Reading Center.~Baseline CSF values were converted from the thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 583 scans. One-year CSF values were converted from a thickness value measured on a Spectralis or Cirrus OCT machine to a Stratus equivalent value for 604 scans. When calculating change in CSF thickness, measurements taken on the same machine at both visits were not converted, since the conversion equation slope is nearly 1 and the constant difference does not affect the change calculation. Therefore, change in CSF thickness was calculated after converting either the baseline and/or follow-up thickness value from Spectralis or Cirrus to a Stratus equivalent value in 26 eyes."|baseline to 1-year|In addition to participants missing the 1-year visit, 3 in the aflibercept group, 3 in the bevacizumab group, and 5 in the ranibizumab group had 1-year visits but unusable OCT data to compute change due to the scan being missing or ungradable at either baseline or 1 year.|||microns||Standard Deviation|Mean
2655356|NCT01627249|Primary|Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year|Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.|Baseline to 1-year|Visual acuity change truncated to +/- 3SD (-22 and +44) to minimize the effects of outliers for 6 eyes in the aflibercept group (4 on the positive end, 2 on the negative end) and 2 eyes in the bevacizumab group (both on the negative end).|||units on a scale||Standard Deviation|Mean
2655357|NCT01627002|Secondary|Assessment of the Effect of PA401 on Induced Sputum Percentage Neutrophils|Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils|5.5 hours post dose||||percentage of total cells||95% Confidence Interval|Least Squares Mean
2655358|NCT01627002|Primary|Assessment of the Effect of PA401 on Induced Sputum Total Neutrophils|Induced sputum was collected 6 hours after lipopolysaccharide challenge (5.5 hours following dosing) and assessed for neutrophils|5.5 hours post dose||||x10e6 cells/g||95% Confidence Interval|Least Squares Mean
2655359|NCT01627002|Secondary|Pharmacokinetic Parameters: Area Under the Plasma Concentration-time Curve From Zero to Infinity||Up to 12 time-points up to 48 hours post dose||||ng.h/mL||Standard Deviation|Mean
2655360|NCT01627002|Secondary|Pharmacokinetic Parameters: Terminal Half-life (t1/2)||Up to 12 time-points up to 48 hours post dose||||hours||Standard Deviation|Mean
2655361|NCT01627002|Secondary|Pharmacokinetic Parameters: Time of Occurrence of the Maximum Observed Plasma Concentration (Tmax)||Up to 12 time-points up to 48 hours post dose||||hours||Standard Deviation|Mean
2655362|NCT01627002|Secondary|Pharmacokinetic Parameters: Maximum Observed Plasma Concentration (Cmax)||Up to 12 time-points up to 48 hours post dose||||ng/mL||Standard Deviation|Mean
2655363|NCT01627002|Primary|Immunogenicity|Anti-drug antibody data|Up to 28 days post dose|Safety analyses were performed on all subjects who received a dose of PA401 or placebo and who had any post-dose assessments|||participants|||Number
2655364|NCT01627002|Primary|Treatment Emergent Adverse Events||up to 14 days post dose|Safety analyses were performed on all subjects who receive a dose of PA401 or placebo and who had any post-dose measurements|||Participants|||Number
2655365|NCT01626989|Secondary|Hypopnea Index (HI)|Hypopnea Index (HI) is the number of hypopneas divided by number of hours of sleep.|Baseline, and 2 nights (1 night for each intervention)|8 participants had missing or unscorable data, therefore they are not included in the analysis.|||events per hour||Standard Deviation|Mean
2655366|NCT01626989|Secondary|Nocturnal Oxygenation|Nocturnal oxygenation measured by continuous pulse oximetry during sleep study.|Baseline, and 2 nights (1 night for each intervention)|8 participants had missing or unscorable data, therefore they are not included in the analysis.|||percent oxygen saturation||Standard Deviation|Mean
2655367|NCT01626989|Secondary|Arousal Index|Arousal Index is the number of arousals and awakenings is registered in the study, and reported as a total number and as a frequency per hour of sleep.|Baseline, and 2 nights (1 night for each intervention)|8 participants had missing or unscorable data, therefore they are not included in the analysis.|||events per hour||Standard Deviation|Mean
2655368|NCT01626989|Secondary|Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep|"Wake (W), Stages N1,N2,N3 (NREM), and REM (R) sleep. REM is the period of rapid eye movement sleep, NREM are stages 1, 2, and 3 of sleep, and Wake (W) is the duration of time from lights out, or bedtime, to the onset of sleep."|Baseline, and 2 nights (1 night for each intervention)|Data was not analyzed as number of minutes, as minutes is not a meaningful measurement. It is best measured respective to % TST in outcome measure 2. This was included in the protocol in error and the protocol was not amended.||||||
2655369|NCT01626989|Secondary|Sleep Efficiency (SE %)|Sleep Efficiency (SE %) is the percentage of time spent asleep while in bed.|Baseline, and 2 nights (1 night for each intervention)|8 participants had missing or unscorable data, therefore they are not included in the analysis.|||percent of time asleep||Standard Deviation|Mean
2655370|NCT01626989|Secondary|Total Sleep Time (TST)|"Total Sleep Time (TST). Total Sleep Time (TST) is the duration of time from lights out, or bedtime, to waking from sleep. The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode"|Baseline, and 2 nights (1 night for each intervention)|8 participants had missing or unscorable data, therefore they are not included in the analysis.|||minutes||Standard Deviation|Mean
2655371|NCT01626989|Secondary|Wake After Sleep Onset (WASO)|Wake After Sleep Onset (WASO) is a statistic used in sleep studies to determine the amount of time a person spends awake, starting from when they first fall asleep to when they become fully awake and do not attempt to go back to sleep.|Baseline, and 2 nights (1 night for each intervention)|8 participants had missing or unscorable data, therefore they are not included in the analysis.|||minutes||Standard Deviation|Mean
2655372|NCT01626989|Secondary|REM Onset Latency (ROL)|REM Onset Latency (ROL) is defined as the time it takes to get into REM sleep from Sleep Onset.|Baseline, and 2 nights (1 night for each intervention)|REM onset latency is not a standard set of sleep scores analyzed. This is not apart of the analysis, this is in the protocol by error. However the protocol was not amended.||||||
2655377|NCT01626989|Secondary|Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Percentage Based on Total Sleep Time (TST) Indices|"REM is the period of rapid eye movement sleep, NREM are stages 1, 2, and 3 of sleep, and Total Sleep Time (TST) is the duration of time from lights out, or bedtime, to the onset of sleep. The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode"|Baseline, and 2 nights (1 night for each intervention)|8 participants had missing or unscorable data, therefore they are not included in the analysis.|||percent of TST||Standard Deviation|Mean
2655378|NCT01626989|Primary|Apnea-Hypopnea Index (AHI)|Apnea-Hypopnea Index (AHI) is the number of apneas and hypopneas per hour of sleep.|Baseline, and 2 nights (1 night for each intervention)|8 participants had missing or unscorable data, therefore they are not included in the analysis.|||events per hour||Standard Deviation|Mean
2655379|NCT01626820|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|SAEs assessed included medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 - Day 20 after vaccination).|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.|||Subjects|||Number
2655380|NCT01626820|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) post-vaccination period.|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration.|||Subjects|||Number
2655381|NCT01626820|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and fever [oral temperature ≥38.0 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination, Any fever = oral temperature ≥38.0 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on theTotal Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed|||Subjects|||Number
2655382|NCT01626820|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling were defined as ecchymosis, induration, redness and swelling above 100 millimeters (mm).|During the 4-day (Days 0-3) post-vaccination period|Analysis was performed on the Total Vaccinated cohort which included all subjects with a documented vaccine administration and symptom sheet completed.|||Subjects|||Number
2655383|NCT01626820|Primary|Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMTs post-vaccination (Day 21) compared to pre-vaccination (Day 0).|At Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Mean
2655384|NCT01626820|Primary|Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine influenza strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.|At Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2655385|NCT01626820|Primary|Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroprotected subject was defined as a subject with serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The influenza vaccine strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.|At Day 0 and Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination|||Subjects|||Number
2655386|NCT01626820|Primary|Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine influenza strains included Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata) antigens.|At Day 0 and Day 21|Analysis was performed on According To Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titer||95% Confidence Interval|Mean
2655387|NCT01626690|Secondary|Temporal Artery Verus SpotOn (3M) Temperature Readings.|Temperature with temporal artery thermometer and SpotOn temperature monitoring device (3M) at time of incision.|The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).||||Degrees Celsius||Standard Deviation|Mean
2655391|NCT01626690|Secondary|Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System.||The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).||||Degrees Celsius||Standard Deviation|Mean
2655392|NCT01626690|Secondary|Patient Temperature 30 Minutes Following Incision as Measured by SpotOn (3M) Temperature Monitoring System.||The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).||||Degrees Celsius||Standard Deviation|Mean
2655393|NCT01626690|Secondary|Patient Temperature Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System.||The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).||||Degrees Celsius||Standard Deviation|Mean
2655394|NCT01626690|Primary|Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System..|Temporal artery temperature readings (in degrees celsius) will be obtained at the time of incision and every 30 minutes while in the OR.|The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).||||Degrees Celsius||Standard Deviation|Mean
2655395|NCT01626664|Secondary|Change in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score|The FACT-Lym consists of a 27-item general core questionnaire (i.e., Functional Assessment of Cancer Therapy - General [FACT-G]) and a 15-item disease-specific questionnaire (Lymphoma Subscale). The FACT-G includes 4 domains: physical well-being, social/family well-being, emotional well-being, and functional well-being. The total FACT-Lym score (0-168) was obtained by summing individual subscale scores. Higher scores for the scales indicate better quality of life. Change was calculated as the value at the last observation minus the value at baseline.|From date of randomization until the date of first documented progression, up to 36 months|All participants in Intention-to-Treat who had both the values at baseline and last observation|||Units on a scale||Standard Deviation|Mean
2655396|NCT01626664|Secondary|Overall Survival|The estimates and summary statistics for OS were calculated based on Kaplan-Meier method, and the median OS was 4.9 months for subjects randomized to the mogamulizumab group versus 6.87 months for subjects randomized to the Investigator's Choice group.|up to 36 months||||percentage of subjects||95% Confidence Interval|Median
2655397|NCT01626664|Secondary|Progression Free Survival|Progression-free survival was defined as the time from the first date of treatment until the date that PD or death was first reported. Disease progression included PD in any compartment per ATL response criteria, clinical progression at the end of the randomized treatment, or disease progression reported during the follow-up period. The date of PD was the earliest date at which disease progression could be declared.|From date of randomization until the date of first documented progression, start of alternative therapy, or date of death from any cause, whichever came first, up to 36 months||||percentage of subjects||95% Confidence Interval|Median
2655398|NCT01626664|Primary|Overall Response Rate|"Overall Response Rate was determined based on the response in all compartments (lymph nodes, extranodal masses, spleen/liver, skin, peripheral blood, and bone marrow), referencing Tsukasaki, 2009 as follows: Complete Response (CR) = All compartments involved with disease must be CR; Uncertified Complete Response (CRu) = > 75% decrease in lymph nodes and/or extranodal disease with all other compartments involved with disease CR; Partial Response (PR) = If any compartment is CR/PR and all other compartments involved with disease are at least SD; Stable Disease (SD) = All compartments involved with disease are SD; Progressive Disease (PD) = PD in any compartment.~Lymph node and extranodal masses response ≥50% decrease by CT, skin response ≥50% decrease in mSWAT score; blood response ≥50% decrease in malignant cells by flow cytometry; normal bone marrow if abnormal at baseline. PD equals New or ≥50% increase in any compartment."|every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first||||participants|||Number
2655399|NCT01626495|Secondary|Number of Subjects With Complete Remission With Incomplete Blood Count Recovery (CRi).|"Complete remission rate for subjects with Non-CNS3 ALL.~National Comprehensive Cancer Network standard response criteria, which define complete remission (CR) as ,5% bone marrow blasts by morphologic determination, with no evidence of extramedullary disease or refractory disease."|4 Weeks||||Participants|||Count of Participants
2655400|NCT01626495|Secondary|Number of Subjects With Complete Remission (CR).|"Complete remission rate for subjects with Non-CNS3 ALL.~National Comprehensive Cancer Network standard response criteria, which define complete remission (CR) as ,5% bone marrow blasts by morphologic determination, with no evidence of extramedullary disease or refractory disease."|4 Weeks||||Participants|||Count of Participants
2655401|NCT01626495|Secondary|The Number of Subjects With a Successful Product Manufactured||24 weeks||||Participants|||Count of Participants
2655402|NCT01626495|Primary|Number of Subjects With Study Related Adverse Events.|"Inclusive of any events that are possibly, likely, or definitely related to study treatment any time from the first day of study treatment until week 24."|24 weeks||||Participants|||Count of Participants
2655403|NCT01626456|Secondary|Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores|This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale), 7 (positive/negative subscales), and 16 (general subscale); maximum scores (worst outcome) equals 210 (total scale), 49 (positive/negative subscales), and 112 (general subscale).|52 weeks|The full analysis set consisted of all subjects who received at least 1 dose of ALKS 9072 and had at least 1 postbaseline assessment of PANSS total score after administration of ALKS 9072.|||units on a scale||Standard Deviation|Mean
2655404|NCT01626456|Secondary|Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests|Includes incidence >2% but <5%.|52 weeks||||participants|||Number
2655738|NCT01623115|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2655405|NCT01626456|Secondary|Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)|The C-SSRS is a questionnaire used for suicide assessment. Subjects are asked a series of questions that determine whether or not the patient demonstrates any suicidal ideation or behavior. The C-SSRS was administered to subjects at each study visit.|52 weeks|Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.|||participants|||Number
2655406|NCT01626456|Secondary|Discontinuation From Study Due to Adverse Events (AEs)|Number of subjects who discontinued the study due to AE.|52 weeks|Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.|||participants|||Number
2655407|NCT01626456|Secondary|Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)|"The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients. Results indicate a change in CGI-S score from baseline to Day 365 based on the observed data."|52 weeks|The full analysis set consists of all subjects who received at least 1 dose of ALKS 9072 and had at least 1 postbaseline assessment of PANSS score after administration of ALKS 9072.|||units on a scale||Standard Deviation|Mean
2655408|NCT01626456|Primary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs)|This measure includes incidences >5%.|52 weeks|Safety population includes all subjects who receive at least 1 dose of ALKS 9072 in the current study.|||participants|||Number
2655409|NCT01626391|Primary|Safety and Tolerability of TRx0237 When Coadministered With an Acetylcholinesterase Inhibitor (AChEI) and/or Memantine|This was assessed by the number of participants who experienced adverse events within each treatment group (TRx0237 versus placebo) during 8 weeks of treatment.|8 weeks|Safety Population|||participants|||Number
2655410|NCT01626352|Secondary|Progression-free Survival|Defined as the time from first treatment until objective tumor progression, relapse from complete response, or death from any cause. Tumor response is defined by the International Working Group (IMW)-revised response criteria for malignant lymphoma (Cheson 2007). This criteria categorizes the response of a patient's tumor to treatment as Complete Response (CR): the disappearance of all disease evidence; Partial Response (PR): regression of measurable disease and no new sites; Stable Disease (SD): less than a PR but not progressive disease (PD); Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir. Patients who are alive and free from disease progression will be censored at the date of last tumor assessment.|After cycles 3 and 6 of each 21-day cycle, and every 3 months thereafter until progression or relapse from complete response for up to 40 months|All enrolled patients who have received study treatment.|||months||90% Confidence Interval|Median
2655411|NCT01626352|Secondary|Number of Patients With Treatment-Related Adverse Events (AEs) as a Measure of Safety|A treatment-related adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator's assessment). Adverse events were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.|after cycles 3 and 6 of each 21-day cycle, and up to 30 days after last dose, projected 24 weeks|All enrolled patients who received the study treatment.|||Participants|||Count of Participants
2655412|NCT01626352|Secondary|Overall Response (OR)|Overall response is the number of patients with observed complete or partial response (CR or PR) as assessed using the International Working Group (IMW) revised response criteria for malignant lymphoma (Cheson 2007). Complete response requires disappearance of all evidence of disease. Partial response requires regression of measurable disease and no new sites.|after cycles 3 and 6 of each 21-day cycle, and every 3 months thereafter, projected 18 months|All patients treated with study drugs and having a post baseline response assessment.|||Participants|||Count of Participants
2655413|NCT01626352|Secondary|Overall Survival (OS)|Defined as the time from Day 1 of study drug administration to date of death from any cause.|every 3 cycles during treatment and every 3 months thereafter until progression or death from any cause, projected 18 months|All enrolled patients who have received study treatment.|||months||90% Confidence Interval|Median
2655414|NCT01626352|Secondary|Time to Progression (TTP)|Defined as the time from date of first treatment to the date of first documented disease progression or relapse from complete response as defined by the International Working Group (IMW)-revised response criteria for malignant lymphoma (Cheson 2007). This criteria categorizes the response of a patient's tumor to treatment as Complete Response (CR): the disappearance of all disease evidence; Partial Response (PR): regression of measurable disease and no new sites; Stable Disease (SD): less than a PR but not progressive disease (PD); Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir.|After cycles 3 and 6 of each 21-day cycle, and every 3 months thereafter until progression or relapse from complete response for up to 40 months|All enrolled patients who have received study treatment.|||months||95% Confidence Interval|Median
2655415|NCT01626352|Secondary|Duration of Response|Defined as the time from date of first documented confirmed response to date of disease progression or relapse from complete response as defined by the International Working Group (IMW)-revised response criteria for malignant lymphoma (Cheson 2007). This criteria categorizes the response of a patient's tumor to treatment as Complete Response (CR): the disappearance of all disease evidence; Partial Response (PR): regression of measurable disease and no new sites; Stable Disease (SD): less than a PR but not progressive disease (PD); Relapsed Disease or PD: Any new lesion or increase by ≥ 50% of previously involved sites from nadir. Patients who are alive and free from disease progression will be censored at the date of last tumor assessment. Patients who begin further anticancer therapy prior to disease progression will be censored at the date of last tumor assessment prior to the start date of the anticancer therapy.|After cycles 3 and 6 of each 21-day cycle and every 3 months thereafter until disease progression or relapse from complete response for up to 38 months|All patients treated with study drugs and having a post baseline response assessment of a complete or partial response.|||months||90% Confidence Interval|Median
2655416|NCT01626352|Primary|Number of Patients With a Complete Response|Disease response assessments will be performed using the International Working Group (IMW)-revised response criteria for malignant lymphoma (Cheson 2007). Complete response requires a disappearance of all evidence of disease.|18 months|All patients treated with study drugs and having a post baseline response assessment.|||Participants|||Count of Participants
2655417|NCT01626118|Secondary|TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours|"Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40 & 48 hours.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 192 units, which represents complete pain relief (4 on scale) at all points after 0."|0-48 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.|||units on a scale*hour||Standard Deviation|Mean
2655418|NCT01626118|Secondary|TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours|"Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, & 24 hours.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 96 units, which represents complete pain relief (4 on scale) at all points after 0."|0-24 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.|||units on a scale*hour||Standard Deviation|Mean
2655419|NCT01626118|Secondary|TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours|"Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7 & 8 hours.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 32 units, which represents complete pain relief (4 on scale) at all points after 0."|0-8 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.|||units on a scale*hour||Standard Deviation|Mean
2655420|NCT01626118|Secondary|Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4).|"Pain relief was assessed with a 5-point categorical scale at all assessment timepoints after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none=0, a little=1, some=2, a lot=3 and complete=4. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3 & 4 hours.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 16 units, which represents complete pain relief (4 on scale) at all points after 0."|0-4 hours||||units on a scale*hour||Standard Deviation|Mean
2655421|NCT01626118|Secondary|VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. Pain intensity is assessed at baseline (time 0) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, and 24 hours.~The VAS summed pain intensity difference (VASSPID) is calculated as a time-weighted sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0-24 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.|||mm*hour||Standard Deviation|Mean
2655422|NCT01626118|Secondary|VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. Pain intensity is assessed at baseline (time 0) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0-8 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.|||mm*hour||Standard Deviation|Mean
2655450|NCT01625689|Primary|Percentage of Participants With Solicited Local and Systemic Reactions|"Local reactions: Nasal discomfort, Runny nose, Stuffy nose, Sneezing, Ear pain~Systemic Reactions: Cough, Headache, Loss of Appetite, Fever, Irritability, Nausea, Sore throat, Lethargy"|Through 7 days following vaccination|Safety analysis population|||percentage of participants|||Number
2655451|NCT01625689|Primary|Percentage of Participants With Unsolicited Adverse Events (AEs)||Throughout study period, through at least 6 months following vaccination||||percentage of participants|||Number
2657218|NCT01607645|Secondary|CRMRD- Defined as Morphologic CR Without Evidence of Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers||Assessed for up to 5 years||||Participants|||Count of Participants
2655423|NCT01626118|Secondary|VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. Pain intensity is assessed at baseline (time 0) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, and 4 hours.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0-4 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.|||mm*hour||Standard Deviation|Mean
2655424|NCT01626118|Primary|The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48)|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain. Pain intensity is assessed at baseline (time 0) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0-48 hours|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.|||mm*hour||Standard Deviation|Mean
2655425|NCT01626092|Secondary|Neurologic Outcomes|Depending upon underlying primary disease, a combination of evaluative tools (e.g. brain magnetic resonance imaging (MRI), clinical neurologic exam, neuropsychologic testing, electromyography) will be applied for assessment of neurologic function and how it may be affected by this reduced-intensity HCT regimen.|Changes from Baseline, Days 30, 60, 100, Year 1, Year 2, Year 3 Following HCT|None of the 3 patients enrolled in the study were evaluable for this outcome. Two had a repeat transplant and one was lost to follow-up.||||||
2655426|NCT01626092|Secondary|Transplant-Related Mortality|Incidence of death due to complications of HCT following this reduced-intensity conditioning regimen.|Day 100 following HCT||||participants|||Number
2655427|NCT01626092|Primary|Donor (Allogeneic) Hematopoietic Engraftment|Number of patients who achieve hematopoietic engraftment - assessment of nucleated peripheral blood cells for donor (allogeneic) chimerism following this reduced-intensity HCT.|Day 100 Following Hematopoietic Cell Transplant (HCT)||||participants|||Number
2655428|NCT01625988|Secondary|Percentage of Responders|"Percentage of participants with greater than 50% reduction in the number of migraine headache days in a 28-day period. The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes duration, and with both (A and B) required features from the IHS ICHD-II definition. Required feature A includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature B includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia."|Baseline, 4, 8, and 12 weeks|All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data during the time period of analysis.|||Percentage of participants|||Number
2655429|NCT01625988|Secondary|Mean Change From Baseline in the Number of Migraine Attacks in the Last 28-day Period of the 12-week Treatment Phase|"A migraine attack was defined as beginning on any day a migraine headache day was recorded and ending when a migraine headache-free day occurred. The criteria for a migraine headache was adapted from the standard IHS ICHD-II guidelines 1.1 and 1.2 (Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes duration, and with both (A and B) required features from the IHS ICHD-II definition. Required feature A includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature B includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. LS means were calculated using MMRM with baseline value, gender, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect."|Baseline, 12 weeks|All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.|||Migraine attacks||Standard Error|Least Squares Mean
2655430|NCT01625988|Secondary|Mean Change From Baseline in the Number of Headache Days in the Last 28-day Period of the 12-week Treatment Phase|"Number of calendar days on which a headache lasts ≥4 hours which includes migraines, probable migraines (PM) and nonmigraines. Criteria for migraine headache (MH) was adapted from standard IHS ICHD-II guidelines 1.1 and 1.2 (Cephalgia 2004). Definition of MH was headache with or without aura, of ≥30 min duration, and with both (A and B) required features from IHS ICHD-II definition. Required feature A includes ≥2 of following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature B includes at least 1 of following during headache: nausea and/or vomiting, or photophobia and phonophobia. PM is headache with or without aura, but missing 1 feature needed to fulfill all criteria for MH. LS means were calculated using MMRM with baseline value, gender, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect."|Baseline, 12 weeks|All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.|||Headache days||Standard Error|Least Squares Mean
2655485|NCT01625377|Secondary|Number of Patients With Treated or Not Treated Biopsy Proven Acute Rejection (BPAR)|Biopsy proven acute rejection was defined as a clinically suspected acute rejection confirmed by biopsy.|at 12 week and 24 week|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at Day 28 and a posterior value were available.|||Patients|||Number
2655431|NCT01625988|Primary|Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-day Period of the 12-week Treatment Phase|"The criteria for a migraine headache was adapted from the standard International Headache Society (IHS) International Classification of Headache Disorders II guidelines 1.1 and 1.2 (ICHD-II, Cephalgia 2004). The definition of a migraine headache was a headache with or without aura, of ≥30 minutes (min) duration, and with both (A and B) required features from the IHS ICHD-II definition. Required feature A includes at least 2 of the following headache characteristics: unilateral location, pulsatile quality, moderate or severe pain intensity, or aggravation by or causing avoidance of routine physical activity. Required feature B includes at least 1 of the following during the headache: nausea and/or vomiting, or photophobia and phonophobia. Least square (LS) means were calculated using mixed model repeated measures (MMRM) with baseline value, treatment, month, and treatment-by-month interaction as fixed effects and participant as random effect."|Baseline, 12 weeks|All participants with a valid 28-day baseline assessment of migraine headache days who received at least 1 dose of study treatment and had evaluable postbaseline headache data.|||Migraine headache days||Standard Error|Least Squares Mean
2655432|NCT01625923|Secondary|Change in Mean Ghrelin Levels Over Time|The investigators seek to determine whether olanzapine promotes secretion of ghrelin in gastroparesis.|8 weeks|Change in mean ghrelin levels over time|||pg/ml||Standard Deviation|Mean
2655433|NCT01625923|Secondary|Change in Mean Gastric Emptying Time|The investigators aim to test gastric motility, including gastric emptying and antroduodenal contractility parameters, by wireless motility capsule (WMC) before and at the completion of the study to determine if olanzapine has any pro-motility effects in gastroparesis.|8 weeks|Change in mean gastric emptying time by WMC|||minutes||Standard Deviation|Mean
2655434|NCT01625923|Primary|Change in Mean Serum Glucose|Subjects will undergo regular testing of blood glucose, insulin, hemoglobin (Hgb) A1c, body mass index (BMI), liver enzymes, thyroid stimulating hormone (TSH), and prolactin levels during the study as well as after treatment completion to determine the safety of the medication. All adverse events will be compiled to investigate the tolerability of the medication.|8 weeks|Change in mean serum glucose|||mg/dl||Standard Deviation|Mean
2655435|NCT01625923|Primary|Mean GCSI-DD Before/After Treatment With Olanzapine|The investigators will utilize the gastroparesis cardinal symptom index daily diary (GCSI-DD) to compare severity of symptoms before and after treatment with olanzapine. The total GCSI-DD is a validated questionnaire that measures the daily relevant symptoms of gastroparesis and ranges from 0 (no symptoms) to 5 (severe symptoms).|8 weeks||||score on a scale||Standard Error|Mean
2655436|NCT01625923|Primary|Change in Mean BMI|Subjects will undergo regular testing of blood glucose, insulin, hemoglobin (Hgb) A1c, body mass index (BMI), liver enzymes, thyroid stimulating hormone (TSH), and prolactin levels during the study as well as after treatment completion to determine the safety of the medication. All adverse events will be compiled to investigate the tolerability of the medication.|8 weeks|Change in mean BMI|||kg/m^2||Standard Deviation|Mean
2655437|NCT01625910|Secondary|Sugar Sweetened Beverages|Change in reported intake of sugar sweetened beverages|Three months|Intention to treat analysis|||cans per day||Standard Error|Mean
2655438|NCT01625910|Primary|Body Mass Index Z-score Change|Change in body mass index z-score change over the three month time period|Three months|All enrolled were analyzed with one exception (due to injury and prolonged cast treatment). An intent-to-treat analysis required that, for those who did not have the follow-up measurement, data were filled in using the experience of those in the control group who had follow-up measurements.|||BMI z-score change||Standard Error|Mean
2655439|NCT01625845|Secondary|Change in Circulating C-Reactive Protein (CRP) From Pre- to Post-Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks||||mg/L||Standard Error|Mean
2655440|NCT01625845|Secondary|Change in Interleukin-1ra (IL-1ra) From Pre- to Post-Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks||||pg/mL||Standard Error|Mean
2655441|NCT01625845|Secondary|Change in Circulating Interleukin-10 (IL-10) From Pre- to Post-Treatment|An anti-inflammatory cytokine measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks|One participant, with extreme outlier values at pre- and post-treatment, was excluded from analyses.|||pg/mL||Standard Error|Mean
2655442|NCT01625845|Secondary|Change in Circulating Interleukin-6 (IL-6) From Pre- to Post-Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks||||pg/mL||Standard Error|Mean
2655443|NCT01625845|Secondary|Change in Circulating Tumor Necrosis Factor-Alpha (TNF-a) From Pre- to Post-Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and12 weeks|Participants with missing TNF-a data were excluded from this analysis.|||pg/mL||Standard Error|Mean
2655444|NCT01625845|Primary|Change in Depressive Symptoms Severity (Hopkins Symptom Checklist Depression Scale; SCL-20) From Pre- to Post- Treatment|Self-reported depressive symptom severity was measured at pre- (0 weeks) and post- (12 weeks) treatment visits by the 20 depression items from the Symptom Checklist 90 (Hopkins Symptom Checklist depression scale; SCL-20). Each item on the scale ranges from 0 (not at all) to 4 (extremely). Total scores are the average across all response items and range from 0 to 4 with higher scores indicating greater levels of depressive symptoms.|0 and 12 weeks||||Change in Total Score||Standard Error|Mean
2655445|NCT01625845|Primary|Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment|Patients underwent ultrasound assessment of brachial FMD in accordance with established guidelines at pre- (0 weeks) and post- (12 weeks) treatment. After a 10-minute supine rest, high-resolution baseline images of the brachial artery were obtained from 3 consecutive cardiac cycles. Next, the forearm cuff was inflated to 250 mmHg for 5 minutes and then was rapidly deflated. At 60 and 90 seconds post-deflation, images from 3 consecutive cardiac cycles were acquired. FMD values were computed as the % change in brachial diameter at either 60 or 90 seconds after cuff deflation|0 and 12 weeks||||% change in brachial diameter||Standard Error|Mean
2655446|NCT01625689|Secondary|Viral Etiologies of Acute Respiratory and Febrile Illness Will be Parameterized as the Percentage of Those With Each Particular Laboratory-confirmed Respiratory Virus Infection Categorized by Vaccine Allocation||6 months post-vaccination|||||||
2655447|NCT01625689|Secondary|Clinical Characteristics of Influenza, Including Influenza Coinfections With Other Bacterial and Viral Respiratory Pathogens, Will be Parameterized as the Percentage of Participants Categorized by Vaccine Allocation||6 months post-vaccination|||||||
2655452|NCT01625689|Primary|Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes|"PDWI: Participants meeting illness criteria, seeking care in health facility, and with wheeze identified by a study physician~Illness criteria: The presence of one Category A (Fever (>=38°C), tachypnea, danger signs (chest-indrawing, lethargy, cyanosis, inability to drink, convulsions), difficult breathing, noisy breathing, ear pain or discharge) or two Category B findings (Cough, rhinorrhea, sore throat, myalgia/arthralgia, chills, headache, irritability/decreased activity, vomiting)~Wheeze: Long high-pitched whistling or musical sound on expiration heard by auscultation"|42 days following vaccination|||||||
2655453|NCT01625689|Primary|Number of Participants With Serious Adverse Events (SAEs), All-cause Hospitalizations, and Protocol-defined Wheezing Illness (PDWI) Episodes|"PDWI: Participants meeting illness criteria, seeking care in health facility, and with wheeze identified by a study physician~Illness criteria: The presence of one Category A (Fever (>=38°C), tachypnea, danger signs (chest-indrawing, lethargy, cyanosis, inability to drink, convulsions), difficult breathing, noisy breathing, ear pain or discharge) or two Category B findings (Cough, rhinorrhea, sore throat, myalgia/arthralgia, chills, headache, irritability/decreased activity, vomiting)~Wheeze: Long high-pitched whistling or musical sound on expiration heard by auscultation"|6 months following vaccination|Safety analysis population|||participants|||Number
2655454|NCT01625507|Secondary|Change in Waist Circumference|Measured using repeated 24 hour dietary recalls (pre and post-intervention|4 months||||cm||95% Confidence Interval|Mean
2655455|NCT01625507|Secondary|Food Availability|questionnaire of items related to the availability in local stores of the food items recommended in the diet for diabetes.|4 months|||||||
2655456|NCT01625507|Secondary|Food Accessibility|questionnaire of items related to financial and physical accessibility of foods in the diet recommended for diabetes|4 months|||||||
2655457|NCT01625507|Secondary|Food Acceptability|questionnaire based on items related to personal and cultural acceptability of the recommended diet|4 months|||||||
2655458|NCT01625507|Secondary|Change in Perceived Dietary Adherence Questionnaire Score|Questionnaire assessing self-reported adherence to 9 criteria, whose individual scores (range 0-7) are summed to get the total score. Maximum total score is 63. Minimum total score is 0. A higher score means higher dietary adherence.|4 months||||units on a scale||95% Confidence Interval|Mean
2655459|NCT01625507|Secondary|Change in Blood Biomarkers|blood lipids: triglyceride, total cholesterol, LDL-cholesterol, HDL-cholesterol|4 months||||mg/dL||95% Confidence Interval|Mean
2655460|NCT01625507|Secondary|Body Composition|body fat and fat-free mass|3 months||||percentage change from baseline||95% Confidence Interval|Mean
2655461|NCT01625507|Secondary|Change in Body Mass Index|Actual weight and height used to calculate BMI pre- and post-intervention|4 months||||kg/m2||95% Confidence Interval|Mean
2655462|NCT01625507|Secondary|Program Retention|attendance at meetings|3 months||||Participants|||Count of Participants
2655463|NCT01625507|Secondary|Change in Hemoglobin A1c|a surrogate of blood glucose control|4 months||||percentage of hemoglobin A1c||95% Confidence Interval|Mean
2655464|NCT01625507|Primary|Change in Nutrient Intake|Measured using repeated 24 hour dietary recalls (pre and post-intervention)|3 months||||grams||95% Confidence Interval|Mean
2655465|NCT01625507|Primary|Change in Macronutrient Intake|Measured using repeated 24 hour dietary recalls (pre and post-intervention)|3 months||||percentage of total energy||95% Confidence Interval|Mean
2655466|NCT01625507|Primary|Change in Total Energy Intake|Measured using repeated 24 hour dietary recalls (pre and post-intervention)|4 months|All participants, intention to treat protocol|||kcal||95% Confidence Interval|Mean
2655467|NCT01625455|Secondary|Quality of Life|"The secondary endpoint is the quality of life as measured on the Dermatology Quality of Life Index (DLQI).~For a series of 10 questions the responses are scored: Very much, scored 3; A lot, scored 2; A little, scored 1; Not at all, scored 0; Not relevant, scored 0; and Question unanswered, scored 0. The scores are summed and the larger the score the greater the effect of the dermatological disease impact on quality of life.~Maximum response for all ten questions 30, minimum 0."|one week||||scores on a scale||Standard Deviation|Mean
2655468|NCT01625455|Primary|Severity of Pruritus|The primary endpoint is the severity of pruritus as measured on the visual analogue scale. A score of 100 indicated the worst pruritus imaginable, while 0 indicated no pruritus.|one week||||units on a scale||Standard Deviation|Mean
2655469|NCT01625416|Secondary|Physical Functioning|The investigators used the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome. No other subscales will be used.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||units on a scale||Standard Deviation|Mean
2655470|NCT01625416|Secondary|Alcohol Use Problems|The investigators used the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome. No sub scales were used.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||units on a scale||Standard Deviation|Mean
2655471|NCT01625416|Primary|Feasibility/Acceptability of Intervention|The investigators used laptop tracking software to assess number of patients using laptops.|Baseline to 6 months||||Participants|||Count of Participants
2655472|NCT01625416|Primary|Technology Use|The investigators used laptop tracking software to determine technology usage.|Baseline to 6 months||||minutes||Standard Deviation|Mean
2655473|NCT01625416|Primary|Change in Depression Symptoms Over the Course of the Six Months After Injury|The investigators used the Patient Health Questionnaire (PHQ-9) as a continuous measure, with scores ranging from 1 to 27. Higher scores represent a worse outcome. No subscales were used.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||units on a scale||Standard Deviation|Mean
2655474|NCT01625416|Primary|Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury|The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure. The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. No subscales were used.|The investigators assessed at baseline, 1-, 3-, and 6-month.||||units on a scale||Standard Deviation|Mean
2657219|NCT01607645|Secondary|Cytogenetic Response Defined as no Detectable Cytogenetic Abnormality in a Subsequent BM Specimen After Induction or Re-induction||Assessed for up to 5 years||||Participants|||Count of Participants
2655475|NCT01625377|Secondary|Number of Patients With Any Adverse Events, Serious Adverse Events, Death and Premature Discontinuation|Baseline was Day 28 visit. This endpoint reports patients with total adverse events (any), serious adverse events, death and premature discontinuation.|Baseline to 24 weeks|The safety population included all randomized patients who received at least one dose of study treatment post-randomization and for whom there was a post-treatment safety assessment.|||Patients|||Number
2655476|NCT01625377|Secondary|Number of Patients in Different Stages of Chronic Kidney Diseases According to the K/DOQI Classification System|"Kidney disease outcomes quality initiative (K/DOQI) classification is based on glomerular filtration rate (GFR), abbreviated MDRD formula (mL/min/1.73m^2) :~Stage 1 : GFR >= 90; Stage 2 = GFR was between 60-89; Stage 3 = GFR was between 30-59 ; Stage 4 = GFR was between 15-29; Stage 5 = GFR was < 15 (or dialysis)"|At Week 24|ITT population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available.|||Patients|||Number
2655477|NCT01625377|Secondary|Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by CKD-EPI Formula|"GFR estimated by using the Chronic kidney disease- epidemiology (CKD-EPI) formula:~eGFR (mL/min/1.73m^2) = 141 * min(C/K,1)^ α * max(C/K,1)^-1.209 * 0.993^A * 1.1018 (if male) * 1.159 (if black) where C = serum creatinine (in mg/dL) ; A = Age (in years); K = 0.7 for women and 0.9 for men; α = -0.329 for women and -0.411 for men. Baseline was Day 28 visit."|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.|||mL/min/1.73m^2||Standard Deviation|Mean
2655478|NCT01625377|Secondary|Change From Baseline (Randomization) in Glomerular Filtration Rate Estimated by Abbreviated Modification of Diet in Renal Disease (MDRD) Formula|"Change in glomerular filtration rate was calculated using the MDRD abbreviated formula.~GFR in mL/min/1.73m^2 for men of non-black ethnicity: 186 * [C/88]^-1.154 * [A]^-0.023*G*R ; C = serum creatinine (in μmol/L); A = Age (in years). G = 0.742 when the patient is a women; Otherwise G=1 R= 1.21 when the patient was of black ethnicity; Otherwise R = 1 Baseline was Day 28 visit."|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.|||mL/min/1.73m^2||Standard Deviation|Mean
2655479|NCT01625377|Secondary|Change From Baseline (Randomization) in Creatinine Clearance Estimated Using the Adjusted Cockcroft-Gault Formula|Creatinine clearance by the Cockcroft-Gault formula is computed in mL/min/1.73m^2 from the creatinine clearance in mL/min by multiplying it by 1.73 and dividing it by the body surface area Baseline was Day 28 visit.|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.|||mL/min/1.73m^2||Standard Deviation|Mean
2655480|NCT01625377|Secondary|Change From Baseline (Randomization) in Urine Protein/Creatinine Ratio|Change in urine protein/creatinine ratio from baseline (randomization) to week 24 post-randomization was one of the efficacy assessments of renal function. Baseline was Day 28 visit.|Baseline, week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom urine protein and creatinine value at day 28 and a posterior value were available. LOCF applied.|||mg/mmol||Standard Deviation|Mean
2655481|NCT01625377|Secondary|Change From Baseline (Randomization) in Serum Creatinine|"Change in serum creatinine concentrations from baseline (randomization) to week 24 post-randomization was one of the efficacy assessments of renal function.~Baseline was Day 28 visit."|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at D28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.|||µmol/L||Standard Deviation|Mean
2655482|NCT01625377|Secondary|Number of Patients With Death or Graft Loss|The graft was presumed to be lost on the day the patient was registered again on the waiting list, or the day he/she received a new graft.|at week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at day 28 and a posterior value were available.|||Patients|||Number
2655483|NCT01625377|Secondary|Number of Patients With Treated or Untreated BPAR With RAI Score Greater Than 3|"Biopsy proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted.~The patients with treated or untreated BPAR having RAI score > 3 were reported in this end point."|At 24 weeks|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at day 28 and a posterior value were available.|||Patients|||Number
2655484|NCT01625377|Secondary|Number of Patients Reported With Different Categories of Severity of BPAR According to Banff Classification|"Biopsy proven acute rejection was defined as a clinically suspected acute rejection confirmed by biopsy.~The severity of BPAR was categorized as :~Mild (Banff grade I, RAI = 4 and 5) Moderate (Banff grade II, RAI = 6 and 7) Severe (Banff grade III, RAI = 8 and 9) Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted."|at 12 week and 24 week|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at day 28 and a posterior value were available.|||Patients|||Number
2655486|NCT01625377|Secondary|Number of Patients With Treatment Failures|"Incidence of treatment failures, assessed with composite criterion including treated biopsy proven acute rejection (tBPAR) with a rejection activity index (RAI) according to Banff classification >3, graft loss or death at 6 months.~Biopsy proven acute rejection (BPAR) was defined as a clinically suspected acute rejection confirmed by biopsy. The Banff Rejection Activity Index (RAI) comprises 3 components scored from 0 to 3: venous endothelial inflammation; bile duct inflammation damage; and portal inflammation; the scores are combined to an overall score (the RAI) ranging from 0 to 9. An overall score of 0-3 is considered indeterminate, score of 4-5 is mild acute, score of 6-7 is moderate acute , and score of 8-9 is severe acute. Only the episode with the highest total RAI score for each participant was counted.~The graft was presumed to be lost on the day the patient was registered again on the waiting list, or the day he/she received a new graft."|At week 12 and week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value at Day 28 and a posterior value were available.|||Patients|||Number
2655487|NCT01625377|Primary|Change From Baseline (Randomization) in Renal Function|"Change in renal function was measured by change in glomerular filtration rate (GFR). GFR calculated using the abbreviated modification of diet in renal disease (aMDRD) formula.~GFR in mL/min/1.73m^2 for men of non-black ethnicity: 186 * [C/88]^-1.154 * [A]^-0.023*G*R ; C = serum creatinine (in μmol/L); A = Age (in years). G = 0.742 when the patient is a women; Otherwise G=1 R= 1.21 when the patient was of black ethnicity; Otherwise R = 1 Baseline was Day 28 visit."|Baseline, Week 24|The Intent to treat (ITT) population included all randomized patients who received at least one dose of study treatment post-randomization and for whom a creatinine value a Day 28 and a posterior value were available. The last observation carried forward (LOCF) is used as imputation of missing data.|||mL/min/1.73m^2||Standard Error|Least Squares Mean
2655488|NCT01625338|Secondary|Percentage of Participants With Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.|Up to Posttreatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2655489|NCT01625338|Secondary|Percentage of Participants With On-treatment Virologic Failure|"On-treatment virologic failure was defined as~Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or~Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or~Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)"|Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
2655490|NCT01625338|Secondary|Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.|Posttreatment Weeks 4 and 24|Full Analysis Set|||percentage of participants|||Number
2655491|NCT01625338|Primary|Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event||Up to 24 weeks|Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2655492|NCT01625338|Primary|Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.|Posttreatment Week 12|Full Analysis Set: participants who were enrolled and received at least 1 dose of study drug.|||percentage of participants|||Number
2655493|NCT01625286|Secondary|Overall Survival - Part B|The interval between the date of randomisation and the date of patient death due to any cause. All Part B patients were analysed, number of deaths is presented.|From date of randomisation, assessed every 12 weeks, up until the time of final statistical analysis. (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).|Part B Intent to Treat (ITT). Not collected in Part A|||months||95% Confidence Interval|Median
2655494|NCT01625286|Secondary|Durable Response Rate (DRR) - Part B|Percentage of patients who have a Complete Response (CR) or Partial Response (PR) lasting continuously for at least 24 weeks as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: PR, >=30% decrease in the sum of the longest diameter of target lesions; CR, disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm.|From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).|Part B, ITT analysis set. Not collected in Part A|||% of participants|||Number
2655495|NCT01625286|Secondary|Duration of Response (DOR) - Part B|Date of first documentation of response (Complete Response/Partial Response) until the date of disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm.. If a subject does not progress following a response, then their DOR will use the PFS censoring time.|From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).|Part B, all patients with a response in the ITT analysis set. Not collected in Part A|||Months||95% Confidence Interval|Median
2655496|NCT01625286|Secondary|Number of Subjects Without Progression Disease at Week 12 - Part A|Percentage of patients with a 12 week visit response of CR, PR or SD (as defined by RECIST 1.1) with no evidence of previous progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm.|up to 12 weeks|Part A Full Analysis Set (FAS). Not recorded in Part B.|||Participants|||Count of Participants
2655557|NCT01624662|Secondary|Change in Rhinorrhea Score (7-day Instantaneous Morning)|Change from baseline in rhinorrhea symptoms, as measured by AM and PM diary symptom scores|Baseline, Week 16 of the double-blind treatment phase|Missing data were imputed using the multiple imputation method in the primary analyses for the co-primary efficacy variables. For other efficacy analyses, missing or invalid values were not imputed.|||units on a scale||Standard Error|Least Squares Mean
2655497|NCT01625286|Secondary|Overall Objective Response Rate|Percentage of patients, taking their best objective tumour response based on RECIST measurements throughout the whole study as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm. Overall Response Rate (ORR) = CR + PR|From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).|Part A:Full Analysis Set (FAS) Part B: Intent to Treat (ITT)|||% of participants|||Number
2655498|NCT01625286|Secondary|Best Objective Response (BOR)|Number of patients, taking their BOR, which is their best objective tumour response based on RECIST measurements throughout the whole study as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm.|From date of randomisation, assessed every 12 weeks (median total treatment duration AZD5363 = 325.5 days; Placebo = 245 days).||||Participants|||Number
2655499|NCT01625286|Secondary|Objective Response Rate (ORR) at Week 12|Percentage of patients who have at least one visit response of Complete Response or Partial Response prior to any evidence of progression at week 12 as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) for target lesions (TL) and assessed by MRI or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Complete Response (CR), disappearance of all target lesions, any pathological lymph nodes selected as TLs must have a reduction in short axis to <10mm; Objective Response Rate (ORR) = CR + PR|RECIST tumour assessments every 12 weeks|Part A:Full Analysis Set (FAS) Part B: Intent to Treat (ITT)|||% of participants|||Number
2655500|NCT01625286|Secondary|Change in Tumour Size at 12 Weeks|Percentage change from baseline to week 12 in sum of longest diameters of target lesions as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1). Based on patients with measurable disease who had sufficient data available to either calculate or impute a change at 12 weeks|RECIST tumour assessments every 12 weeks|Part A:Full Analysis Set (FAS) Part B: Intent to Treat (ITT)|||% change from baseline||Standard Deviation|Mean
2655501|NCT01625286|Primary|Progression Free Survival (PFS) - Part B|Time from randomisation to date of objective disease progression or death (by any cause in the absence of progression). Progression defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a >= 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on the study, and an absolute increase of >=5mm, or progression of non-target lesions or the appearance of new lesions.|From randomisation date to date of objective disease progression or death (by any cause) whichever came first, assessed every 12 wks (median total treatment duration AZD5363=325.5 days; Placebo=245 days)|Intent to Treat (ITT), all randomised patients|||Months||95% Confidence Interval|Median
2655502|NCT01625286|Primary|Dose-limiting Toxicity (DLT) Events - Part A|An Adverse Event (AE) or laboratory abnormality considered to be related to study drug, that starts at any time during the DLT evaluation period (Cycle 1) and is dose limiting|During Part A DLT evaluation period (Cycle 1, up to 28 days)|All Part A patients who either completed the DLT evaluation period with at least 80% of specified dose (of AZD5363 or paxlitaxel) or who experienced a DLT. DLT events were not assessed for Part B participants.|||participants|||Number
2655503|NCT01625221|Primary|Reduction in Fecal Incontinence Symptoms|Effectiveness will be characterized as the reduction of FI symptoms by subjective measurements using the FISI, Wexner, and FIQOL scores and a three week diary documenting episodes of incontinence.|12 Months||||episodes per week||Standard Deviation|Mean
2655504|NCT01625221|Primary|Adverse Events|The safety objective will be met via reporting all adverse events at various time points including implant, 6 weeks, 3 months, 6 months, and 12 months (and then semi-annually until 5 years post-implant at U.S. sites). Serious device- and procedure-related adverse events will be summarized separately. Safety will be characterized by physical examination and pelvic X-ray evaluations.|60 months|All adverse events as reported by investigators|||Number of events|||Number
2655505|NCT01625182|Secondary|Change From Baseline for Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS)|This questionnaire was constructed using the patients' perception of their ability to perform daily and social activities. The questionnaire comprises 24 items ranging from ability to read a book or newspaper (as the easiest item to accomplish) to ability to run (most difficult item to accomplish). The obtained raw summed score was translated subsequently to a convenient centile metric score ranging from 0 (most severe disability) to 100 (no disability at all). A higher score indicated a better health status. A negative change from baseline indicates deterioration.|baseline, Month 6, Month 12|Only participants from the FAS, who had non-missing baseline values and the given post-baseline values, were included in the analysis. The FAS included all participants who were assigned randomly to receive treatment.|||score on a scale||95% Confidence Interval|Least Squares Mean
2655506|NCT01625182|Secondary|Change From Baseline for Grip Strength, Non-dominant Hand|Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration.|baseline, Month 6, Month 12|Only participants from the FAS, who had non-missing baseline values and the given post-baseline values, were included in the analysis. The FAS included all participants who were assigned randomly to receive treatment.|||kPa||95% Confidence Interval|Least Squares Mean
2655507|NCT01625182|Secondary|Change From Baseline for Grip Strength, Dominant Hand|Grip strength measurements were done using a vigorimeter. With this device, the pressure in the bulb exercised by the participant was registered on a manometer via a rubber junction tube. Both the dominant and non-dominant hands were tested. A negative change from baseline indicates deterioration.|baseline, Month 6, Month 12|Only participants from the FAS, who had non-missing baseline values and the given post-baseline values, were included in the analysis. The FAS included all participants who were assigned randomly to receive treatment.|||kPa||95% Confidence Interval|Least Squares Mean
2657220|NCT01607645|Secondary|Resistant Disease Defined as Patient Survives at Least 14 Days After Completion of the Last Dose of Induction or Re-induction But Has Persistent Leukemia in Peripheral Blood (PB) or BM||Assessed for up to 90 days||||Participants|||Count of Participants
2655508|NCT01625182|Primary|Time to First Confirmed Worsening on the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale|Confirmed worsening in CIDP was measured by the adjusted INCAT Disability Scale. The adjusted INCAT disability scale measures arm disability and leg disability. For arm disability the scale ranges from 0 (no upper limb problems) to 5 (inability to use either arm for any purposeful movement). The leg disability scale ranges from 0 (walking not affected) to 5 (restricted to wheelchair, unable to stand and walk a few steps with help). The total adjusted INCAT disability score is calculated by the sum of the arm and leg disability scores where the total score ranges from 0 to 10. A confirmed worsening was defined as an increase by 1 or more points on the adjusted INCAT disability scale from the value at baseline.|Month 12|The full analysis set, which included all participants who were assigned randomly to receive treatment, was analyzed.|||Days||95% Confidence Interval|Median
2655509|NCT01625169|Secondary|HIV Viral Load in Breast Milk and Plasma|Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml|Day 14|One participant did not complete D14 visit.|||participants|||Number
2655510|NCT01625169|Secondary|HIV Viral Load in Breast Milk and Plasma|Positive HIV RNA in breast milk and plasma- LDL 40 copies/ml|Day 5|One participant did not complete Visit D5.|||participants|||Number
2655511|NCT01625169|Primary|Area Under the Curve (AUC) 0-12 for Breast Milk|AUC 0-12 ng*hr/ml|Day 14|One participant did not complete D14 visit.|||ng*hr/ml||Standard Deviation|Mean
2655512|NCT01625169|Primary|Area Under the Curve (AUC) 0-12 for Breast Milk|AUC 0-12 ng*hr/ml|Day 5|One participant did not complete D5 visit.|||ng*hr/ml||Standard Deviation|Mean
2655513|NCT01625169|Primary|Area Under the Curve (AUC) 0-12 for Plasma|AUC 0-12 ng*hr/ml|Day 14: 0, 2,4, 8 and 24 hours post dose|One participant did not complete D14 visit.|||ng*hr/ml||Standard Deviation|Mean
2655514|NCT01625169|Primary|Area Under the Curve (AUC) 0-12 for Plasma|AUC 0-12 ng*hr/ml|Day 5: 0, 2,4, 8 and 24 hours post dose|One participant did not complete Day 5 visit.|||ng*hr/ml||Standard Deviation|Mean
2655515|NCT01625169|Primary|Peak Plasma Concentration of Etravirine in Plasma|Cmax ng/mL|day 14|Note: One participant did not complete the Day 14 evaluation.|||ng/ml||Standard Deviation|Mean
2655516|NCT01625169|Primary|Peak Concentration of Etravirine in Breast Milk|Cmax ng/mL|day 14|Note: One participant did not complete the Day 14 evaluation.|||ng/ml||Standard Deviation|Mean
2655517|NCT01625169|Primary|Peak Concentration of Etravirine in Breast Milk|"Cmax ng/ml~Note: One participant did not complete the Day 5 evaluation."|day 5|Note: One participant did not complete the Day 5 evaluation.|||ng/ml||Standard Deviation|Mean
2655518|NCT01625169|Primary|Peak Plasma Concentration of Etravirine in Plasma|"Cmax ng/ml~Note: One participant did not complete the Day 5 evaluation."|Day 5|Note: One participant did not complete the Day 5 evaluation.|||ng/ml||Standard Deviation|Mean
2655519|NCT01625104|Primary|Percentage of Sites With Reduction in Door to Balloon Time|"Arrival time in Emergency Department to first balloon inflation in the coronary artery.~Any reduction in median Door to Balloon Time from baseline to follow-up was counted as reduction in time"|Arrival to balloon inflation, measured in minutes (generally less than 120 mins)||||percentage of sites with improved D2B|||Number
2655520|NCT01625091|Secondary|Craving for Alcohol|Self-reported scale of alcohol craving ranging from 0 (no craving) to 10 (strongest craving)|4 months||||units on a scale||Standard Deviation|Mean
2655521|NCT01625091|Secondary|Drinking Problems (SIP-2R Score)|The Short Inventory of Problems (SIP-2R) seeks to measure the consequences of drinking in participants through questions related to guilt, reliability etc. The SIP-2R has 15 items asking how often the event happened during the past 3 months. Each item has a score from 0-3 (0=Never, 1=once or a few times, 2=once or twice a week, 3=daily or almost daily). The 15 questions from the SIP-2R are summed to create a total range of scores from 0-45.|4 months||||units on a scale||Standard Deviation|Mean
2655522|NCT01625091|Secondary|Number of Binge Drinking Days|In the past 30 days, total number of days with binge drinking which was defined as consuming ≥4 drinks on a single day (measured by Timeline Follow Back).|Month 4||||Days||95% Confidence Interval|Median
2655523|NCT01625091|Primary|Number of Participants Who Quit Hazardous Drinking|The primary statistical outcome for the trial is alcohol consumption at month 4 when the drug is stopped. This main outcome is a categorical variable of either quit hazardous drinking (defined as ≤7 drinks per week and <4 drinks on any single day in the past 30 days), or did not quit (drinking exceeds the hazardous amount) .|Month 4||||Participants|||Count of Participants
2655524|NCT01625013|Secondary|Identify the Effects of Treatment on Activity Levels|To identify the effects of treatment with hylan G-F 20 on activity levels (using objective activity measures utilizing accelerometer and Physical Activity Enjoyment Scale (PACES) and quality of life scores (WOMAC, SF-12) comparing baseline to treatment at 3 months.|26 weeks post-injection through 3 years post-injection||2020-08-31|08/2020||||
2655525|NCT01625013|Secondary|The Effect of Repeated Treatments|Though symptoms can be improved for periods up to 6 months, pain symptoms can recur. The effect of repeated treatments of hylan G-F 20 will be studied.|26 weeks post-injection through 3 years post-injection||2020-08-31|08/2020||||
2655526|NCT01625013|Primary|Decreased Pain|To identify whether injection of 6 mL hylan G-F 20 decreases pain over 26 weeks in young (ages 30 to 50 years) active patients with symptomatic primary osteoarthritis of the knee not treated previously with hylan G-F 20.|26 weeks post-injection through 3 years post-injection|Patients at 6-months post-injection #1|||percentage of patients|||Number
2655544|NCT01624740|Primary|Change in Back Pain Intensity|"Back pain intensity was measured on a 0-10 numerical rating scale (0=no pain, 10=worst pain imaginable) at baseline and following low rate and high rate stimulation. This outcome measure compared the change in intensity from baseline between low rate and high rate stimulation."|For this measure, outcome was assessed at baseline, the end of the first intervention (3 or 4 days post-implantation, depending on the subject), and the end of the second intervention (6 or 8 days post-implantation, depending on the subject).||||Percent Change From Baseline||Standard Deviation|Mean
2655558|NCT01624662|Secondary|Nasal Congestion/Obstruction Score (7-day Instantaneous Morning)|Measured by the 7-day average instantaneous morning diary symptom scores|Week 16 of the double-blind treatment phase|The Full Analysis Set includes subjects who received at least one dose of study drug and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms.|||units on a scale||Standard Error|Least Squares Mean
2655527|NCT01624974|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Score at Week 4|The change from baseline in the ACQ score at Week 4, after treatment, was assessed in 97 participants. Participants completed 6 items of the ACQ (i. e., ACQ-6) and provided the average of responses over the past week: 1) Frequency of nocturnal awakenings (0 = Never, 6 = Unable to sleep); 2) Symptom severity (0 = None, 6 = Very severe); 3) Activity limitations (0 = Not limited, 6 = Totally limited); 4) Breathlessness (0 = None, 6 = Very great deal); 5) Wheezing (0 = Not at all, 6 = All the time); 6) Daily SABA use (0 = None, 6 = More than 16 puffs on most days). The ACQ score ranges from 0 to 6 where a lower score indicates greater performance. The investigator reviewed the participant-completed ACQ-6 to ensure its completeness. The change from baseline in the ACQ score was evaluated using the LDA model with repeated measurements of the ACQ score, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect.|The week before the first dose in Period III or V (Baseline) and the last week of Period III or V|All randomized participants who received at least one dose of study treatment in any crossover period (i.e., Period III or Period V), and had at least one measurement for the outcome analysis. A participant in the Placebo + ML arm received treatment in both Period III and Period V, and resulted in 99 measurements from 97 participants.|||Score on a scale|ACQ Measurements|Standard Deviation|Mean
2655528|NCT01624974|Secondary|Change From Baseline in Evening (PM) PEF at Week 4|The change from baseline in PM PEF at Week 4 after treatment with MK-1029 + ML or placebo + ML was assessed. Participants performed triplicate PM PEF measurements in the evening, immediately before study drug administration, at bedtime. Participants entered all 3 measurements and the greatest PM PEF value was recorded by the e-Diary. Participants refrained from SABA use within the 4 hours prior to performing PEF measurements. The average PM PEF for an individual participant was calculated over the week-long assessment periods. The change from baseline in PM PEF was evaluated using the LDA model with repeated measurements of PM PEF, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect.|Baseline (Week 0 and Week 8), Last week of the 4-week treatment period|All randomized participants who received at least one dose of study treatment in any crossover period (i.e., Period III or Period V), and had at least one measurement for the outcome analysis.|||Liters/min||Standard Deviation|Mean
2655529|NCT01624974|Secondary|Change From Baseline in Morning (AM) Peak Expiratory Flow (PEF) at Week 4|The change from baseline in AM PEF at Week 4 after treatment with MK-1029 + ML or placebo + ML was assessed in 97 participants. Participants performed triplicate AM PEF measurements in the morning upon rising. Participants entered all 3 measurements and the greatest AM PEF value was recorded by the e-Diary. Participants refrained from SABA use within the 4 hours prior to performing PEF measurements. The average AM PEF for an individual participant was calculated over the week-long assessment periods. The change from baseline in AM PEF was evaluated using the LDA model with repeated measurements of AM PEF, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect.|The week before the first dose in Period III or V (Baseline) and the last week of Period III or V|All randomized participants who received at least one dose of study treatment in any crossover period (i.e., Period III or Period V), and had at least one measurement for the outcome analysis. A participant in the Placebo + ML arm received treatment in both Period III and Period V, and resulted in 98 measurements from 97 participants.|||Liters/min|AM PEF Measurements|Standard Deviation|Mean
2655530|NCT01624974|Secondary|Change From Baseline in Nocturnal Awakenings at Week 4|"The change from baseline in nocturnal awakenings due to asthma at Week 4 after treatment with MK-1029 + ML or placebo + ML was assessed. The participant scored nocturnal awakenings by answering the question, Did you wake up with asthma symptoms in the middle of the night or upon awakening in the morning? (No or Yes). Participants recorded in the e-Diary the number of nights per week in which they awakened with asthma, as determined by dividing the number of nights of awakening with asthma by the total number of nights and then multiplying by 7 (standardized to a 7-day period). The change from baseline in nocturnal awakenings was evaluated using the LDA model with repeated measurements of nocturnal awakenings, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect."|The week before the first dose in Period III or V (Baseline) and the last week of Period III or V|All randomized participants who received at least one dose of study treatment in any crossover period (i.e., Period III or Period V), and had at least one measurement for the outcome analysis.|||Number of nocturnal awakenings||Standard Deviation|Mean
2655531|NCT01624974|Secondary|Change From Baseline in Short-Acting Beta Agonist (SABA) Use at Week 4|The change from baseline in SABA use at Week 4 after treatment with MK-1029 + ML or placebo + ML was assessed. Participants used the e-Diary upon arising and before going to sleep to enter the total number of SABA puffs used for asthma relief. The number of SABA puffs recorded was the number of canister actuations (e. g., when SABA use was required and 3 puffs were inhaled, this was recorded as 3). Participants also recorded the number of nebulizer treatments (1 nebulized SABA use = 3 puffs). The average daily number of puffs for an individual participant was calculated over the week-long assessment periods. The change from baseline in SABA use was evaluated using the LDA model with repeated measurements of SABA use, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect.|The week before the first dose in Period III or V (Baseline) and the last week of Period III or V|All randomized participants who received at least one dose of study treatment in any crossover period (i.e., Period III or Period V), and had at least one measurement for the outcome analysis. A participant in the Placebo + ML arm received treatment in both Period III and Period V, and resulted in 98 measurements from 97 participants.|||Number of puffs|SABA Use Measurements|Standard Deviation|Mean
2655545|NCT01624662|Secondary|Peak Nasal Inspiratory Flow (PNIF)|"The PNIF is an assessment of nasal passage obstruction and was measured using an In-Check portable nasal inspiratory flow meter. To measure PNIF, a mask was placed over the nose during inspiration and inspiratory flow was recorded. Each subject inhaled 3 times and each measurement was recorded. The PNIF value used was the greatest of the 3 results at each time point.~Change from baseline in Peak Nasal Inspiratory Flow (PNIF)"|Week 16 of the double-blind treatment phase; Week 24 of the open-label extension phase|Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase.|||L/min||Standard Error|Least Squares Mean
2657234|NCT01607450|Secondary|GLP-1 Concentrations|Achieved GLP-1 concentrations at the end of the 12 hour treatment exposure|After 12 hours of GLP-1 exposure|Analyses performed only on the groups with relevant primary outcome data observed|||pmol/L||Standard Deviation|Mean
2655532|NCT01624974|Secondary|Change From Baseline in Daytime Symptom Score (DSS) at Week 4|The change from baseline in DSS at Week 4 following treatment was assessed. Participants used an electronic diary (e-Diary) to enter their asthma symptom scores every evening. Participants scored daily symptoms (chest discomfort, wheezing, shortness of breath, and cough) by responding to 4 questions: 1) Symptom frequency (0 = None of the time, 6 = All of the time); 2) Bothersomeness (0 = Not bothered, 6 = Severely bothered); 3) Activity limitation (0 = Not limited, 6 = Totally limited); 4) Frequency of activity limitation (0 = None of the time, 6 = All of the time). The average of the 4 scores for overall DSS ranges from 0 to 6 where a higher average indicates greater symptom severity. The average overall DSS was calculated over the week-long assessment periods. The change from baseline in DSS was evaluated using the LDA model with repeated measurements of DSS, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect.|The week before the first dose in Period III or V (Baseline) and the last week of Period III or V|All randomized participants who received at least one dose of study treatment in any crossover period (i.e., Period III or Period V), and had at least one measurement for the outcome analysis.|||Score on a scale||Standard Deviation|Mean
2655533|NCT01624974|Primary|Discontinuation of Treatment Due to An Adverse Event|The number of participants who discontinued study treatment due to an AE was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.|Up to the last dose in Period III or Period V (up to 4 weeks)|All randomized participants who received at least one dose of study treatment and had follow-up.|||Participants|||Count of Participants
2655534|NCT01624974|Primary|Adverse Events During Treatment and Follow-up|The number of participants who had at least one adverse event (AE) during study treatment and follow-up was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. The number of participants with at least one AE was assessed. The number of participants in any treatment group with at least one AE was assessed.|Up to 14 days after the last dose in Period III or Period V (up to 6 weeks)|All randomized participants who received at least one dose of study treatment and had follow-up.|||Participants|||Count of Participants
2655535|NCT01624974|Primary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 4|The change from baseline in FEV1 at Week 4 following treatment with MK-1029 + ML or placebo + ML was assessed. The pre-bronchodilator FEV1 was evaluated to assess the response to treatment for asthma. The primary efficacy evaluation period was the last week of each treatment period: Period III (Initial Therapy, Week 4) and Period V (Crossover Therapy, Week 4). The change from baseline in FEV1 was evaluated using a longitudinal data analysis (LDA) model with repeated measurements of FEV1, with treatment, visit, treatment-by-visit interaction, and period as fixed effects, and participant as random effect. Baseline FEV1 is defined as the measurement taken before dosing in each treatment period (i. e., at Visit 3 [Week 0], prior to Period III and at Visit 6 [Week 8], prior to Period V). The Baseline Characteristics section shows FEV1 values at baseline.|The week before the first dose in Period III or V (Baseline) and the last week of Period III or V|All randomized participants who received at least one dose of study treatment in any crossover period (i.e., Period III or Period V), and had at least one measurement for the outcome analysis, as well as a pre-dose baseline measurement.|||Liters||95% Confidence Interval|Least Squares Mean
2655536|NCT01624948|Secondary|Median Between the Calculated Mean Residual Expression of NFAT-regulated Genes|"Measurement of the expression of three NFAT-regulated genes IL-2, interferon gamma, and GM-CSF, to predict a rejection episode.~The residual gene expression after Tacrolimus intake was calculated as T1.5/T0*100, where T0 is the adjusted number of transcripts at Tacrolimus pre-dose level and T1.5 is the number of transcripts 1.5 hours after drug intake. For all three genes the residual expression was averaged and presented as MRE of NFAT-regulated genes."|3 months post-randomization|a subset of 19 participants enrolled in the immune-monitoring portion of the study|||percent residual expression||95% Confidence Interval|Median
2655537|NCT01624948|Secondary|Proteinuria||3 months post-randomization||||g/g creatinine||Standard Deviation|Mean
2655538|NCT01624948|Secondary|Cholesterol||3 months post-randomization||||mg/dL||Standard Deviation|Mean
2655539|NCT01624948|Secondary|p70S6 Kinase Phosphorylation||3 months post-randomization|19 patients enrolled in the immune-monitoring subset; 1 participant did not have a 3-month assay.|||Mean Fluorescence Intensity||95% Confidence Interval|Median
2655540|NCT01624948|Secondary|Evaluation for the Development of BK Virus Nephropathy or Doubling of BK Viremia Levels|A doubling of BK viremia levels or the development of BKV nephropathy in subjects enrolled in the experimental study arm will prompt a conversion to standard care therapy. We will closely monitor BKV levels in the urine and blood and assess renal function monthly, as per our usual standard of care. Based on BKV results as well as renal function, as assessed by serum Cr, biopsies may be done for cause. Patients will have a final visit at month 4 to monitor for adverse events.|3 months post-randomization||||participants|||Number
2655541|NCT01624948|Primary|Evidence of Reduction of BK Viruria and/or Clearance of BK Viremia|composite outcome of a 50% or greater reduction in BKV urine levels and/or complete clearance of BKV viremia by 3 months after randomization|3 months post-randomization||||participants|||Number
2655542|NCT01624870|Secondary|Combined Safety Endpoint|The Kaplan-Meier estimate of all-cause mortality, major stroke, life threatening (or disabling) bleeding, acute Kidney Injury - Stage 3 (including renal denervation therapy), peri-procedural myocardial infarction or repeat procedure for valve related dysfunction (surgical or interventional). A Kaplan Meier assessment was used to determine the composite rate.|30 days post procedure|All implanted|||Percentage of subjects|||Number
2655543|NCT01624870|Primary|New-onset Class I or II Indication for Permanent Pacemaker Implantation|The Kaplan-Meier estimate of new-onset class I or II indication for permanent pacemaker implantation at 30 days for implant depth ≤6mm or >6mm. Where class I is defined as evidence and/or general agreement that a given treatment or procedure is beneficial, useful, and effective and class II is defined as conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a given treatment or procedure according to the 2007 ESC guidelines.|30 days post procedure|the populations used for this parameter are sub-population of the 194 implanted subjects for whom data of implant depth was available|||Percentage of subjects||95% Confidence Interval|Number
2655546|NCT01624662|Secondary|Number of Participants Eligible for Nasal Polyp Surgery|"A subject was considered eligible for surgical intervention if the following conditions were met:~Subject has had moderate symptoms of congestion from nasal polyposis for ≥ 3 months.~Subject continues to suffer from at least moderate symptoms despite use of topical steroids at conventional doses for ≥ 6 weeks.~Subject continues to suffer from at least moderate symptoms despite use (or previous use) of saline lavage for ≥ 6 weeks.~Subject has endoscopically visualized bilateral nasal polyposis of at least moderate severity (nasal polyp grading score ≥ 2 in at least 1 nostril)."|Week 16 of the double-blind treatment phase; Week 24 of the open-label extension phase|Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase.|||Participants|||Count of Participants
2655547|NCT01624662|Secondary|Number of Participants in Each Category of PGIC|"Patient Global Impression of Change; subject responses to the question: Since starting the study drug, how would you rate the change in your symptoms? Percentage includes patients who scored either very much improved, much improved, or minimally improved."|Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase|Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase.|||Participants|||Count of Participants
2655548|NCT01624662|Secondary|SF-36v2 - Physical Component|The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire that measures 8 domains of health: limitations in physical activities, limitations in social activities, limitations in usual role activities, bodily pain, general mental health, limitations in usual role activities, vitality, and general health perceptions. It yields scale scores for each of the 8 health domains, and 2 summary measures of physical and mental health. Each scale range is from 0-100. A lower score means more disability and a higher score means less disability.|Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase|Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase.|||units on a scale||Standard Error|Least Squares Mean
2655549|NCT01624662|Secondary|SF-36v2 - Mental Component|The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire that measures 8 domains of health: limitations in physical activities, limitations in social activities, limitations in usual role activities, bodily pain, general mental health, limitations in usual role activities, vitality, and general health. It yields scale scores for each of the 8 health domains, and 2 summary measures of physical and mental health. Each scale range is from 0-100. A lower score means more disability and a higher score means less disability.|Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase|Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase.|||units on a scale||Standard Error|Least Squares Mean
2655550|NCT01624662|Secondary|Rhinosinusitis Disability Index (RSDI) Total Score|The RSDI is a subject-completed instrument that evaluates the self-perceived impact of disease specific head and neck disorders. The RSDI has 30 items in 3 domains: Physical (11 items), Functional (9 items), and Emotional (10 items). The RSDI scale ranges from 0-120, 0 being better quality of life and less impact of CRS on daily function and 120 being worse quality of life and more impact of CRS on daily function.|Baseline, Week 16 of the double-blind treatment phase||||units on a scale||Standard Error|Least Squares Mean
2655551|NCT01624662|Secondary|MOS Sleep-R Score|The MOS Sleep-R is a brief, self-administered, validated questionnaire designed to measure key aspects of sleep, such as disturbance, adequacy, somnolence, and quantity. The 12-item version with a 4-week recall was used in this study. The score range for the 12-item version is 0 to 100, lower scores indicating better sleep and higher scores indicating worse sleep. The scale yields a Sleep Problem Index and scores on the following 6 subscales: Sleep Disturbance, Snoring, Shortness of Breath or Headache, Sleep Adequacy, Sleep Somnolence, and Sleep Quantity.|Baseline, Week 16 of the double-blind treatment phase||||units on a scale||Standard Error|Least Squares Mean
2655552|NCT01624662|Secondary|Sinonasal Outcome Test 22 (SNOT-22) Total Score|"SNOT-22 is a subject-completed questionnaire that consists of 22 questions. The questions on the SNOT-22 efficacy evaluation were used to calculate a total score. 22 questions are divided among 4 subscales: Rhinologic (7 questions), Ear/Facial Symptoms (4 questions), Sleep Function (3 questions), and Psychological Issues (6 questions). Each item was rated on the 5-point scale. The total score can range from 0-110, 0 being the best and 110 being the worst.~0: No problem~Very mild problem~Mild or slight problem~Moderate problem~Severe problem~Problem as bad as it can be"|Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase|Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase.|||units on a scale||Standard Error|Least Squares Mean
2655553|NCT01624662|Secondary|Polyp Grade of 0 in at Least One Nostril|"Subjects with a Polyp Grade of 0 (None) in at least one nostril~Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. This outcome measured how many patients with a polyp grad of 0 in at least 1 nostril.~0: No polyps~Mild polyposis: polyps not reaching below the inferior border of the middle turbinate~Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate~Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate"|Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase|Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase.|||Participants|||Count of Participants
2655554|NCT01624662|Secondary|Change in Total Nasal Polyp Score|"Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy.~0: No polyps~Mild polyposis: polyps not reaching below the inferior border of the middle turbinate~Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate~Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate~Determined by a nasal polyp grading scale score (sum of scores from both nasal cavities measured by nasoendoscopy)"|Baseline, Week 24 of the open-label extension phase|The Full Analysis Set includes subjects who received at least one dose of study drug and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms.|||units on a scale||Standard Error|Least Squares Mean
2655559|NCT01624662|Primary|Change in Total Polyp Grade|Determined by a nasal polyp grading scale score (sum of scores from both nasal cavities) measured by nasoendoscopy|Baseline, Week 16 of the double-blind treatment phase|The Full Analysis Set includes subjects who received at least one dose of study drug and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms.|||units on a scale||Standard Error|Least Squares Mean
2655560|NCT01624662|Primary|Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms|"Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.~0: None~Mild, symptoms clearly present, but minimal awareness, and easily tolerated~Moderate, definite awareness of symptoms that is bothersome but tolerable~Severe, symptoms that are hard to tolerate, cause interference with activities or daily living~During the single-blind run-in phase and during the 16-week, double-blind treatment phase, an electronic diary was provided to each subject. Subjects reported both instantaneous (evaluation of symptom severity immediately preceding the time of scoring) and reflective (evaluation of symptoms severity over the previous 12 hours) scores for nasal congestion/obstruction symptoms."|Baseline, Week 4 of the double-blind treatment phase|The Full Analysis Set includes subjects who received at least one dose of study drug and who had baseline assessments of polyp size (nasoendoscopy) and recorded morning nasal congestion/obstruction symptoms.|||units on a scale||Standard Error|Least Squares Mean
2655561|NCT01624467|Secondary|Number of Participants With an Incidence of Anti-Necitumumab Antibodies||Baseline to Post Infusion 30 Day Follow-up|All participants who received at least 1 dose of study drug and had at least 1 post-infusion blood sample.|||participants|||Number
2655562|NCT01624467|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) (Tumor Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST 1.1])|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1,CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100. PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD.|Baseline to Measured Progressive Disease (up to 21 Months)|All participants who received any study drug and had CR or PR.|||percentage of participants||95% Confidence Interval|Number
2655563|NCT01624467|Secondary|Pharmacokinetics: Maximum Drug Concentration (Cmax) of Necitumumab||Cycle 1 (Days 1 and 36); Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hours|All participants who received at least one dose of study drug and had evaluable PK parameters in Cycle 1, Days 1 and 36.|||microgram/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2655564|NCT01624467|Secondary|Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Necitumumab From Zero to Infinity (AUC[0-∞])||Cycle1 (Days 1 and 36): Pre-infusion, 50 minutes, 1.5, 2.5, 4.5, 24, 28, 72, and 168 hours|All participants who received at least one dose of study drug and had evaluable PK parameters in Cycle 1 on Days 1 and 36.|||microgram*hour/milliliter (μg*h/ml)||Geometric Coefficient of Variation|Geometric Mean
2655565|NCT01624467|Secondary|Change From Time-Matched Baseline in Heart Rate (HR) (Electrocardiographic Parameters: Heart Rate [HR])|Change in HR from time-matched measures performed at baseline.|Baseline, Cycle1 Day 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion|QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG|||Beats/minute||Standard Deviation|Mean
2655566|NCT01624467|Secondary|PR Change From Time-Matched Baseline ≥25% and Absolute Value of PR > 200 Msec (Electrocardiographic Parameters: PR Interval)||Baseline, Cycle1 Day 1, 8, 15, 22, 29, 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion|QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG.|||percentage of participants|||Number
2655567|NCT01624467|Secondary|Change From Time-Matched Baseline ≥ 25% and Absolute Value of QRS >110 Msec (Electrocardiographic Parameters: QRS Interval)||Baseline, Cycle1 Day 1, 8, 15, 22, 29, 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion|QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG|||participants|||Number
2655568|NCT01624467|Primary|Change From Time-Matched Baseline in QT Interval Corrected for Heart Rate (QTc)|The corrected QT interval was calculated using Fridericia's correction (QTcF) from electrocardiogram (ECG) data. Each participant had triplicate QT intervals measured at each timepoint and the average was calculated for each participant at each timepoint. For each timepoint, a participant's corresponding baseline (Day -1, pretreatment) QTcF interval was subtracted from the average QTcF intervals to create the change from time-matched baseline in the QTcF interval|Baseline, Cycle1 Day 1, 8,15, 22, 29, and 36: Pre-infusion, End of Infusion, 1 Hour (hr), 2, 4, 24, 48, 72 hr Post Infusion|QTC evaluable population: all participants who received at least 1 dose of study drug and at least 1 post-infusion ECG.|||milliseconds (msec)||90% Confidence Interval|Mean
2655569|NCT01624363|Primary|Prevalence of Pancreatic Cysts During Routine EUS|The purpose of this study is to identify the prevalence of pancreatic cysts in patients undergoing EUS for non-pancreatic indications .|48 months||||participants found to have a cyst|pancreas'|95% Confidence Interval|Median
2655570|NCT01624350|Secondary|Pain|Pain by VAS (Visual Analog Scale) VAS is a 10-point scale with 0 being no pain and 10 being the most pain.|Baseline, 1 month, 3 months, 6 months and 12 months|Participants include number of patients who completed questionnaire|||Participants|||Count of Participants
2655571|NCT01624350|Secondary|Patient Satisfaction Between the First and Last Post-operative Visit|Patient satisfaction questionnaire included questions regarding fecal continence and overall satisfaction with the operation.|Between the first and last visits|Number of participants completed a satisfaction questionnaire at least twice.|||Participants|||Count of Participants
2655609|NCT01624233|Secondary|Change From Baseline in Participants Assessment of Joint Pain Visual Analog Scale (VAS) (Efficacy of Ixekizumab in Participants With PsA Pain VAS)|The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0 mm (no pain) to 100 mm (pain as severe as you can imagine).|Baseline, Wk 12; Baseline, Wk 52|Participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline.|||mm||Standard Deviation|Mean
2655572|NCT01624350|Secondary|Fecal Incontinence|Fecal Incontinence change from baseline as measured by CCF-FI questionnaire. This questionnaire is a summed score of 5 individual parameters (frequency of incontinence to gas, liquid solid, of need to wear pad, and of lifestyle changes) It is measured from a patient-completed questionnaire with each parameter given a score from 0 to 4, with 0 indicating its absence and 4 indicating daily presence. These values are added to give a total score ranging from 0 to 20 (0 indicating perfect control, 10-15 indicating moderate incontinence, and greater than 15 indicating severe incontinence.|3 months, 6 months and 12 months|The CCF-FI score was calculated if a score was ticked for each of the five types of incontinence. If a patient had a type of incontinence with a missing score, then the CCF-FI score was not calculated. Change = Value and Month X - Value at Baseline.|||units on a scale||Standard Deviation|Mean
2655573|NCT01624350|Secondary|Participant Response to Quality of Life EQ-5D Questionnaire|Quality of Life by EQ-5D questionnaire is a standardized measure of health status. It is a 25-item questionnaire that measures quality of life of patients pre and post surgery in the following categories: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each category has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.|Baseline, and 3 months, 6 months and 12 months post op|Number analyzed include participants who completed questionnaire.|||participants|||Number
2655574|NCT01624350|Secondary|Fistula Healing in Patients at 3 and 12 Months Following Surgery|Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.|3 months and 12 months|Number of participants analyzed includes patients who had their assessment performed and the final assessment of patients who exited from the study early.|||percentage of patients||95% Confidence Interval|Number
2655575|NCT01624350|Primary|Fistula Healing in Patients at 6 Months Following Surgery|Clinical assessment of fistula healing as defined by 1) no discharge from the fistula and 2) the external opening has closed.|6 months|Number of participants analyzed includes patients who had their assessment performed and the final assessment of patients who exited from the study early.|||percentage of participants|||Number
2655576|NCT01624259|Secondary|Percent Change From Baseline in Lipid Parameters at 26 Weeks|A summary of percent change in lipid parameters (total cholesterol, high-density lipoprotein cholesterol [HDL-C], low density lipoprotein cholesterol [LDL-C], very low-density lipoprotein cholesterol [VLDL], and triglycerides) from baseline to primary endpoint of 26 weeks is presented. LS means of the lipid parameter from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, country, baseline HbA1c strata, and lipid parameter baseline as covariates, via ANCOVA with LOCF.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable lipid laboratory data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percent||Standard Error|Least Squares Mean
2655577|NCT01624259|Secondary|Number of Participants With Treatment Emergent LY2189265 Antibodies up to 26 Weeks and 4 Weeks After Last Dose|LY2189265 (dulaglutide) anti-drug antibodies (ADA) were assessed at baseline, 26 weeks, and at the safety follow-up visit 4 weeks after study drug discontinuation in dulaglutide-treated participants. A participant was considered to have treatment emergent LY2189265 ADA if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. The number of participants with treatment-emergent LY2189265 ADA from postbaseline to follow up were summarized.|Baseline up to 4 Weeks Post Last Dose of Study Drug|Participants who were randomized and received at least 1 dose of LY2189265 with evaluable LY2189265 ADA data.|||participants|||Number
2655578|NCT01624259|Secondary|Number of Participants With Allergic or Hypersensitivity Reactions|Allergic and hypersensitivity reactions that were considered possibly related to study drug by the investigator are presented. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable adverse event data.|||participants|||Number
2655579|NCT01624259|Secondary|Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia|An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who had no rescue therapy within specified study period were considered as censored observations at the last available contact date up to specified study period.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable concomitant medication data.|||weeks||95% Confidence Interval|Median
2655580|NCT01624259|Secondary|Rate of Hypoglycemic Events Adjusted Per 30 Days|HE were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a PG concentration of ≤70 mg/dL), asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL), nocturnal (events that occurred between bedtime and waking), or probable symptomatic (events during which symptoms of hypoglycemia were not accompanied by a PG determination but that was presumably caused by a PG of ≤70 mg/dL). The hypoglycemia rate per 30 days was calculated by the number of hypoglycemia events within the period/number of days participant at risk within the period*30 days. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable hypoglycemic episode data. Only pre-rescue measurements were used.|||number of events/participant/30 days||Standard Deviation|Mean
2655581|NCT01624259|Secondary|Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia|An additional intervention (rescue therapy) was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable concomitant medication data.|||percentage of participants|||Number
2655582|NCT01624259|Secondary|Percentage of Participants With Self-Reported Hypoglycemia Events|"Hypoglycemic events (HE) were classified as severe (episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (any time a participant felt that he/she was experiencing symptoms and/or signs associated with hypoglycemia and had a plasma glucose [PG] concentration of ≤70 mg/dL), asymptomatic (events not accompanied by typical symptoms of hypoglycemia but with a measured PG of ≤ 70 mg/dL), nocturnal (events that occurred between bedtime and waking), or probable symptomatic (events during which symptoms of hypoglycemia were not accompanied by a PG determination but that was presumably caused by a PG of ≤70 mg/dL).~A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable hypoglycemia event data. Only pre-rescue measurements were used.|||percentage of participants|||Number
2655583|NCT01624259|Secondary|Change From Baseline in Amylase at 26 Weeks|A summary of participants having changes in amylase evaluation from baseline to primary endpoint of 26 weeks is presented.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable amylase laboratory data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||U/L||Inter-Quartile Range|Median
2655584|NCT01624259|Secondary|Change From Baseline in Lipase at 26 Weeks|A summary of participants having changes in lipase evaluation from baseline to primary endpoint of 26 weeks is presented.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable lipase laboratory data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units/liter (U/L)||Inter-Quartile Range|Median
2655585|NCT01624259|Secondary|Change From Baseline in Calcitonin at 26 Weeks|A summary of participants having changes in calcitonin values from baseline to primary endpoint of 26 weeks is presented.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable calcitonin laboratory data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||picograms/milliliter (pcg/mL)||Inter-Quartile Range|Median
2655586|NCT01624259|Secondary|Number of Participants With Adjudicated Acute Pancreatitis Events|"The number of participants with events of pancreatitis confirmed by adjudication were summarized cumulatively at 26 weeks (including a 30-day follow up). Pancreatitis events were adjudicated by a committee of physicians external to the Sponsor.~A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module."|Baseline up to 30 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable adverse event data.|||participants|||Number
2655587|NCT01624259|Secondary|Change From Baseline in Blood Pressure (BP) at 26 Weeks|Descriptive statistics for the actual measurements and change from baseline for sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured. LS means of change from baseline were calculated using MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects, baseline BP as a covariate, and participant as a random effect.|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable BP data.|||milliliters of mercury (mmHg)||Standard Error|Least Squares Mean
2655588|NCT01624259|Secondary|Change From Baseline in Heart Rate (HR) at 26 Weeks|Descriptive statistics for the actual measurements and LS means of change from baseline for HR (sitting) by treatment arm were analyzed using the MMRM model with treatment, country, visit, and treatment-by-visit interaction as fixed effects, baseline rate as a covariate, and participant as a random effect.|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable heart rate data.|||bpm||Standard Error|Least Squares Mean
2655589|NCT01624259|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters PR and QTcF (Fridericia's) Intervals at 26 Weeks|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave. QTcF is the measure of the time between the start of the Q wave and the end of the T wave adjusted using Fridericia's formula. PR is the interval between the P wave and the QRS complex. These parameters were calculated from electrocardiogram (ECG) data. LS means of change from baseline for the PR and QTcF intervals will be analyzed using the MMRM similar to MMRM model for primary outcome, using corresponding baseline and HbA1c strata. Only ECGs obtained at scheduled visits will be used in these summaries and analyses.|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable ECG PR or QTcF interval data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||milliseconds (msec)||Standard Error|Least Squares Mean
2655590|NCT01624259|Secondary|Change From Baseline in Electrocardiogram (ECG) Parameters, Heart Rate (HR) at 26 Weeks|ECG HR was measured. LS means of change from baseline were analyzed using ANCOVA with HbA1c strata, country, and treatment as fixed effects and baseline HR as a covariate.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable ECG heart rate data. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2655591|NCT01624259|Secondary|Number of Participants With Reported and Adjudicated Cardiovascular Events|Deaths and nonfatal cardiovascular (CV) adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal CV AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with reported CV events, number of participants with nonfatal CV events confirmed by adjudication, and number of deaths confirmed by adjudication are summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable adjudicated CV event data.|||participants|||Number
2655592|NCT01624259|Secondary|Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β)- Cell Function (HOMA2-%B) at 26 Weeks|"The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%.~LS means of the HOMA2-%B change from baseline to primary endpoint at Week 26 was adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline HOMA2-%B value as covariate, via an ANCOVA analysis using LOCF."|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable HOMA2-%B data. LOCF was used to impute missing postbaseline values. If there was no data after date of randomization, the endpoint was considered missing.|||percentage of HOMA2-%B||Standard Error|Least Squares Mean
2655593|NCT01624259|Secondary|Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) ≤6.5% or <7% at 26 Weeks|The percentage of participants who achieved the target HbA1c values at the primary endpoint were analyzed with a repeated logistic regression model (the generalized estimation equation [GEE] model). The model includes pooled country, treatment, visit, treatment-by-visit interaction, and baseline HbA1c as continuous covariates.|Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable HbA1c data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||percentage of participants|||Number
2655594|NCT01624259|Secondary|Change From Baseline in 7-Point Self Monitored Plasma Glucose (SMPG) at 26 Weeks|"The SMPG data were collected at the following 7 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal; and bedtime. The mean of the 7 time points (Daily Mean) was also calculated.~LS means of the SMPG change from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, HbA1c strata, country, visit, treatment-by-visit interaction, participant as random effect and baseline SMPG as a covariate, via a MMRM analysis using REML."|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable 7-Point SMPG data. Only pre-rescue measurements were used.|||mg/dL||Standard Error|Least Squares Mean
2655595|NCT01624259|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at 26 Weeks|LS means of the FPG from baseline to primary endpoint at Week 26 were adjusted by fixed effects of treatment, country, baseline HbA1c strata, and baseline FPG as covariates, via ANCOVA with LOCF.|Baseline, Up to 26 Weeks|"Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable FPG data. Only pre-rescue measurements were used.~LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing."|||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
2655596|NCT01624259|Secondary|Change From Baseline in Body Mass Index (BMI) at 26 Weeks|BMI is an estimate of body fat based on body weight divided by height squared. LS means of the BMI change from baseline to primary endpoint at Week 26 were calculated using ANCOVA with HbA1c Strata, country, and treatment as fixed effects and baseline BMI as a covariate.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or liraglutide with evaluable BMI data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.|||kilograms/square meter (kg/m^2)||Standard Error|Least Squares Mean
2655597|NCT01624259|Secondary|Change From Baseline in Body Weight at 26 Weeks|LS means of the weight change from baseline to primary endpoint at Week 26 were calculated using analysis of covariance (ANCOVA) with HbA1c Strata, country, and treatment as fixed effects and baseline body weight as a covariate.|Baseline, Up to 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable body weight data. Only pre-rescue measurements were used. Last observation carried forward (LOCF) was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing.|||kilograms (kg)||Standard Error|Least Squares Mean
2655598|NCT01624259|Primary|Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)|Least Squares (LS) means of the glycosylated hemoglobin A1c (HbA1c) change from baseline to the primary endpoint at Week 26 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect, and baseline HbA1c as covariates, via a mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML).|Baseline, 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or Liraglutide with evaluable HbA1c data|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2655599|NCT01624233|Secondary|Number of Participants Achieving ACR20|"ACR20 response is defined as ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: participant's assessment of Joint Pain VAS, Patient's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, participant's assessment of physical function using the HAQ-DI, or CRP or the ESR.~Analysis population included participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline."|Wk 100 and Wk Retreatment Wk 192|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 100 and 192.|||Participants|||Count of Participants
2655600|NCT01624233|Secondary|Change From Baseline in Participants Assessment of Joint Pain VAS|The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine).|Baseline, Wk 100; Baseline, Retreatment Wk 192|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing Joint Pain VAS at Wks 100 and 192 were imputed by LOCF.|||mm||Standard Deviation|Mean
2655634|NCT01624194|Secondary|Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment.|Scale measuring severity of anxiety symptoms. Higher scores mean higher levels of anxiety, lower scores mean lower levels of anxiety. (Raw Score Range: 0 - 114)|Baseline; Week 4|Participants who completed the protocol are included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2655601|NCT01624233|Secondary|Change From Baseline in DLQI Score|"DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered (not relevant) responses were scored as 0. Total scores range from 0 to 30, with higher scores indicating greater quality of life impairment. A 5-point increase in total score from baseline is considered clinically relevant."|Baseline, Wk 100; Baseline, Retreatment Wk 192|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing DLQI at Wks 100 and 192 were imputed by LOCF.|||units on a scale||Standard Deviation|Mean
2655602|NCT01624233|Secondary|Change From Baseline in Itch NRS Score|The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10, (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline, Wk 100; Baseline, Retreatment Wk 192|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing Itch NRS at Wks 100 and 192 were imputed by LOCF.|||units on a scale||Standard Deviation|Mean
2655603|NCT01624233|Secondary|Change From Baseline in QIDS-SR16 Score|QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst) scale. The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.|Baseline, Wk 100; Baseline, Retreatment Wk 192|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing QIDS-SR16 at Wks 100 and 192 were imputed by LOCF.|||units on a scale||Standard Deviation|Mean
2655604|NCT01624233|Secondary|Change From Baseline in PSSI|The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity.|Baseline, Wk 100; Baseline, Retreatment Wk 192|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing PSSI at Wks 100 and 192 were imputed by LOCF.|||units on a scale||Standard Deviation|Mean
2655605|NCT01624233|Secondary|Change From Baseline in NAPSI|The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants in matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all the fingernails equals the total NAPSI score with a range 0 to 80. Higher scores indicate more severe psoriasis.|Baseline, Wk 100; Baseline, Retreatment Wk 192|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing NAPSI at Wks 100 and 192 were imputed by LOCF.|||units on a scale||Standard Deviation|Mean
2655606|NCT01624233|Secondary|Change From Baseline in Percent of BSA Involvement|BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb).|Baseline, Wk 100; Baseline, Retreatment Wk 192|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing BSA at Wks 100 and 192 were imputed by last observation carried forward (LOCF).|||percentage of BSA||Standard Deviation|Mean
2655607|NCT01624233|Secondary|Percentage of Participants With sPGA (0 or 1) and sPGA (0)|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear) or 1 (minimal).|Wk 100 and Retreatment Wk 192|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 100 and 192.|||percentage of participants|||Number
2655608|NCT01624233|Secondary|Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated: 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling, with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Wk 100 and Retreatment Wk 192|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 100 and 192.|||percentage of participants|||Number
2665367|NCT01534208|Primary|Change From Baseline in Total Morning Testosterone at 26 Weeks|Changes in values from baseline of total morning testosterone levels at Week 26|6 months|Intent to Treat population|||ng/dL||Standard Deviation|Mean
2655610|NCT01624233|Secondary|Number of Participants Achieving American College of Rheumatology 20% (ACR20) Improvement [Efficacy of Ixekizumab in Participants With Psoriatic Arthritis (PsA) as Measured by ACR20]|ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: participant's assessment of Joint Pain visual analog scale (VAS), Patient's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, participant's assessment of physical function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or C-reactive protein (CRP) or the erythrocyte sedimentation rate (ESR).|Wks 12, 24 and 52|Participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline.|||participants|||Number
2655611|NCT01624233|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score|"DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered (not relevant) responses were scored as 0. Total scores range from 0 to 30, with higher score indicating greater quality of life is impairment. A 5-point increase in total score from baseline is considered clinically relevant."|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|Participants with Plaques Ps who had DLQI at baseline and at least 1 post-dose result. Participants with missing DLQI at Wks 12 and 52 were imputed by LOCF.|||units on a scale||Standard Deviation|Mean
2655612|NCT01624233|Secondary|Change From Baseline in Itch Numeric Rating Scale (NRS) Score|The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|Participants with Plaque Ps who had Itch NRS at baseline and at least 1 post-dose result. Participants with missing Itch NRS at Wks 12 and 52 were imputed by LOCF.|||units on a scale||Standard Deviation|Mean
2655613|NCT01624233|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]|QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|Participants with Plaque Ps who had QIDS-SR16 at baseline and at least 1 post-dose result. Participants with missing QIDS-SR16 at Wks 12 and 52 were imputed by LOCF.|||units on a scale||Standard Deviation|Mean
2655614|NCT01624233|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI)|The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity.|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|All participants with Plaque Ps with a PSSI baseline and at least 1 post-dose result. Participants with missing PSSI at Wks 12 and 52 were imputed by LOCF.|||units on a scale||Standard Deviation|Mean
2655615|NCT01624233|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants in matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all fingernails equals the total NAPSI score with a range from range 0 to 80. Higher scores indicated more severe psoriasis.|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|All participants Plaque Ps with NAPSI at baseline and at least 1 post dose result. Participants with missing NAPSI at Wks 12 and 52 were imputed by LOCF.|||units on a scale||Standard Deviation|Mean
2655616|NCT01624233|Secondary|Change From Baseline in Percent of Body Surface Area (BSA) Involvement|BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb).|Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52|All participants with Plaque Ps with a baseline and at least 1 post-dose result. Participants with missing BSA at Wks 12 and 52 were imputed by last observation carried forward (LOCF).|||percentage of BSA||Standard Deviation|Mean
2655617|NCT01624233|Secondary|Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA)|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear) or 1 (minimal).|Wks 12, 24 and 52|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of sPGA after study treatment. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI analysis for Wks 12 and 52.|||percentage of participants|||Number
2655633|NCT01624194|Secondary|Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment.|Higher Social Standard Score means better social skills, lower Social Standard Score means worse social skills. Higher Communication Standard Score means better communication skills, lower Communication Standard Score means worse communication skills. Standard Scores can range from 20 to 160.|Baseline; Week 4|Participants with available data are included.|||units on a scale||Standard Deviation|Mean
2655618|NCT01624233|Secondary|Percent of Participants Achieving PASI 90% and 100% Improvement|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Wks 12, 24 and 52|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 12 and 52.|||percentage of participants|||Number
2655619|NCT01624233|Secondary|Number of Participants With Anti-Ixekizumab Antibodies|Treatment-emergent immunogenicity is defined as any occurrence of a 4-fold or 2-dilution increase in titer over the pretreatment baseline titer. In the case of a negative result at baseline, treatment-emergent immunogenicity is defined as an increase in titer to ≥1:10.|Baseline through Wk 52|All participants with Plaque Ps, Pustular Ps or Erythrodermic Ps who received at least 1 dose of study drug.|||participants|||Number
2655620|NCT01624233|Secondary|Pharmacokinetics (PK): Ctrough at Steady State (Ctrough ss) of Ixekizumab|PK samples were from 1 or 2 sampling cohorts. Ctrough is the minimum observed concentration of ixekizumab at steady state. Steady-state ixekizumab trough concentrations were summarized for the induction dosing period at week 12, the time of the primary efficacy assessment. Steady-state ixekizumab trough concentrations were summarized for the maintenance dosing period at week 24.|Pre-dose at Wks 12 (Day 84) and Wks24 (Day 168)|All participants with Plaque Ps, Pustular Ps or Erythrodermic Ps who had at least 1 dose of study drug and evaluable Ctrough data at the specified time points.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2655621|NCT01624233|Secondary|Percentage of Participants Achieving ≥75% Improvement in PASI|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region, the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Wks 24 and 52|All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 measurement of PASI after study treatment. Non-responders and participants who discontinued at any time prior to Wk 52 were defined as non-responders for NRI analysis.|||percentage of participants|||Number
2655622|NCT01624233|Primary|Percentage of Participants Achieving ≥75% Improvement in Psoriasis Area and Severity Index (PASI) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: PASI)|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).|Week (Wk) 12|All participants with Plaque Ps who received at least one dose of study drug and had at least 1 measurement of PASI after study treatment. Non-responders and participants who discontinued at any time prior to specified time points were defined as non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
2655623|NCT01624194|Secondary|Change From Baseline in Blood Pressure||Baseline; Week 4|Participants with available data are included in the analysis.|||mmHg||95% Confidence Interval|Least Squares Mean
2655624|NCT01624194|Secondary|Change From Baseline in Heart Rate||Baseline; Week 4|Participants with available data are included in the analysis.|||beats per minute||95% Confidence Interval|Least Squares Mean
2655625|NCT01624194|Secondary|Change From Baseline in Weight||Baseline; Week 4||||kilograms||95% Confidence Interval|Least Squares Mean
2655626|NCT01624194|Secondary|Change From Baseline in Parent Rated Repetitive Behavior Scale- Revised (RBS-R) Scores During Treatment.|Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129)|Baseline; Week 4|Only analyzed after 4 weeks.|||units on a scale||Standard Error|Least Squares Mean
2655627|NCT01624194|Secondary|Change From Baseline in Plasma Oxytocin Levels During Treatment.|"This outcome originally specified that oxytocin, vasopressin, and cortisol levels would be assessed; however, data on vasopressin and cortisol levels were not collected during the study.~There are no clinical laboratory tests that establish a normative range for oxytocin. Measurements prior to and following treatment were intended to evaluate oxytocin level as a predictor of response."|Up to 4 weeks|Participants with available data were included in the analysis.|||pg/mL||Standard Deviation|Mean
2655628|NCT01624194|Secondary|Change From Baseline in Developmental NEuroPSYchological Assessment (NEPSY-II) Affect Recognition Scores During Treatment.|"Higher Affect Recognition scores mean better affect recognition abilities, lower Affect Recognition scores mean worse affect recognition abilities.~Scores can range from 1 to 19."|Baseline; Week 4|Participants with available data were included.|||units on a scale||Standard Deviation|Mean
2655629|NCT01624194|Secondary|Change From Baseline in Laboratory Based Social Mimicry Abilities During Treatment.||Up to 4 weeks|Data were not not collected for this outcome.||||||
2655630|NCT01624194|Secondary|Change From Baseline in Reading the Mind in the Eyes Test, Child Version (RMET-child) Scores During Treatment.||Up to 4 weeks|Data were not not collected for this outcome.||||||
2655631|NCT01624194|Secondary|Change From Baseline in Laboratory Based Eye-gaze to Social Cues During Treatment.||Baseline; Week 4|Data not collected.||||||
2655632|NCT01624194|Secondary|Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment.||Up to 4 weeks|Data were not collected for this outcome.||||||
2655635|NCT01624194|Secondary|Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4|Higher scores indicate more symptoms, lower scores indicate fewer symptoms. Irritability scores can range from 0-45. Lethargy scores can range from 0-48. Stereotypy scores can range from 0-21. Hyperactivity scores can range from 0-48. Inappropriate speech scores can from 0-12.|Baseline; Week 4|Participants with available data are included.|||units on a scale||Standard Deviation|Mean
2655636|NCT01624194|Secondary|Clinical Global Impression-Improvement (CGI-I) Score at Week 4|This outcome is reported as the count of participants in each CGI-I rating category at the week 4 visit, assessing change over the 4-week period. CGI-I rating of 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7=Very Much Worse.|Baseline to Week 4|Participants with available data are included.|||Participants|||Count of Participants
2655637|NCT01624194|Secondary|Change From Baseline in Height.||Baseline; Week 4|Participants with available data are included in the analysis.|||cm||95% Confidence Interval|Least Squares Mean
2655638|NCT01624194|Secondary|Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment|Dosage Record Treatment Emergent Symptom Scale (DOTES) side effects reported by parents during 4-weeks of treatment. Participant Counts are used.|Baseline through Week 4||||participants|||Number
2655639|NCT01624194|Primary|Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment.|Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities. (Raw Score Range: 0 - 195)|Baseline; Week 4|Participants who completed the protocol are included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2655640|NCT01624168|Secondary|Change From Baseline in Pittsburgh Sleep Quality Index Scores|Sleep quality was measured by the Pittsburgh Sleep Quality Index Total Score. Lower scores on this scale reflect better outcomes. Scores can range from 0 to 21.|baseline, 4 weeks, 10 weeks, 2 month follow-up||||units on a scale||Standard Error|Mean
2655641|NCT01624168|Secondary|Change From Baseline in State Anxiety Scores|Anxiety was measured by the State Trait Anxiety Inventory - State Scale. Lower scores on this scale reflect better outcomes. Scores can range from 20 to 80.|change from baseline to 4 weeks, 10 weeks, 2 month follow-up||||units on a scale||Standard Error|Mean
2655642|NCT01624168|Primary|Adherence to Practice After the Intervention|Subjects are considered adherent to practice after the intervention if they practice an average of 2 times per week.|2 months||||participants|||Number
2655643|NCT01624168|Primary|Adherence to Out-of-class Practice|Subjects are considered adherent to out-of-class practice if he/she practices outside of class twenty times during the 10 week intervention|10 weeks||||participants|||Number
2655644|NCT01624168|Primary|Retention of Randomized Subjects for Follow-up|Subjects retained for follow-up are those willing to respond to follow-up assessments|2 months||||participants|||Number
2655645|NCT01624168|Primary|Retention of Randomized Subjects During Intervention|Retained subjects are those who are willing to return for complete assessments|10 weeks||||participants|||Number
2655646|NCT01624142|Secondary|Percentage of Participants With a 15% or Greater Reduction in LDL-C||Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216|Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.|||percentage of participants|||Number
2655647|NCT01624142|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio||Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216|Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.|||percent change||Inter-Quartile Range|Median
2655648|NCT01624142|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio||Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216|Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.|||percent change||Inter-Quartile Range|Median
2655649|NCT01624142|Secondary|Percent Change From Baseline in Apolipoprotein B||Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216|Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.|||percent change||Inter-Quartile Range|Median
2655650|NCT01624142|Secondary|Percent Change From Baseline in Lipoprotein (a)||Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216|Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.|||percent change||Inter-Quartile Range|Median
2655651|NCT01624142|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)||Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216|Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.|||percent change||Inter-Quartile Range|Median
2655652|NCT01624142|Secondary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)||Baseline and weeks 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, and 216|Participants who received at least 1 dose of evolocumab in Study 20110271 and with available data at each time point.|||percent change||Inter-Quartile Range|Median
2655653|NCT01624142|Primary|Number of Participants With Adverse Events|The severity of each adverse event (AE) was graded according to the National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) grading scale, where grade 1 = mild AE, grade 2 = moderate AE, grade 3 = severe AE, grade 4 = life-threatening AE and grade 5 = death due to AE.|From first dose of study drug in Study 20110271 up to 30 days after the last dose or until the end of study date, whichever was earlier; median duration of treatment was 48.7 months.|All participants who received at least one dose of evolocumab in Study 20110271|||Participants|||Count of Participants
2655665|NCT01623752|Other Pre-specified|Number of Participants With Pregnancy, Puerperium and Perinatal Conditions|In this outcome measure total number of participants with pregnancy, puerperium and perinatal conditions are reported. Pregnancy, puerperium and perinatal conditions included pregnancy, abortion, abortion spontaneous or premature baby.|Baseline up to Week 156|Safety analysis set included all patients who received at least 1 dose of Etanercept.|||Participants|||Count of Participants
2655654|NCT01624090|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approx. 9 mos & 6 days DL1 30 mcg/kg thoracic group, 2 mos & 16 days DL1 30 mcg/kg extra-thoracic group, 5 mos & 26 days DL-1 25 mcg/kg thoracic group, & 20 days DL-1 25 mcg/kg extra-thoracic group|One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.|||Participants|||Count of Participants
2655655|NCT01624090|Primary|Number of Participants With an Objective Response (Complete Response + Partial Response)|Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesion, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions). Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Every 8 weeks until disease progression or unacceptable toxicity, over an average of 4 months.|One participant in DL1 30 mcg thoracic died on study, one participant in DL1 30 mcg extra thoracic experienced a dose limiting toxicity and was taken off therapy, and 1 withdrew prior to trmt, two participants in DL1 25 mcg thoracic died on study, and two did not complete one course of therapy prior to treatment evaluation for this outcome measure.|||Participants|||Count of Participants
2655656|NCT01623869|Secondary|OS|Overall survival (OS) is the duration of time from the date of registration/randomization to the date of death or the date of last follow-up for patients who remain alive or who are lost to follow-up at the time of the analysis. Kaplan-Meier methodology will be used to estimate the distribution of OS.|From the date of registration to the date of death or the date of last follow-up, assessed up to 18 months||||months||95% Confidence Interval|Median
2655657|NCT01623869|Secondary|Progression Free Survival (PFS)|Progression-free survival (PFS) is defined as the duration of time from the start of treatment to time of radiologic or clinical progression or death, whichever occurs first. PFS will be censored at most recent radiographic assessment date for patients remaining alive at the time of the statistical analysis. Kaplan-Meier methodology will be used to estimate the distribution of PFS.|From the start of treatment to time of radiologic or clinical progression or death, whichever occurs first, assessed up to 18 months||||months||95% Confidence Interval|Median
2655658|NCT01623869|Primary|Confirmed Response Rate (CR or PR) Using RECIST|"Response and progression will be evaluated using the international RECIST guidelines (v1.1). Patients are evaluated every 8 weeks for disease status, with a subsequent 4 week assessment required to confirm a response.~Complete Response (CR) - All of the following must be true:~Disappearance of all target and non-target lesions,~Each target lesion and non-target lymph node must have reduction in short axis to <1.0 cm.~Partial Response (PR):~At least a 30% decrease from the baseline measurements of the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation.~Persistence of one or more non-target lesions or non-target lymph nodes. The confirmed response rate is estimated as the number of patients having a CR or PR, divided by the number of eligible patients having at least one post-baseline assessment. The 95% confidence intervals provided using the method of Duffy and Santner."|Up to 18 months||||percentage of participants||95% Confidence Interval|Number
2655659|NCT01623830|Secondary|State Trait Anxiety Inventory- Trait (STAI-Trait)|The STAI-Trait is a 20-item self report scale employing a Likert scale format with 4 responses per item (1-4). The possible range of scores is from 20-80, and higher scores indicate greater levels of anxiety. Ten of the STAI items measure feelings of stress and anxiety, while the remaining ten items measure feelings of relaxation.|post-treatment (9 weeks)||||units on a scale||Standard Deviation|Mean
2655660|NCT01623830|Secondary|State Trait Anxiety Inventory- State (STAI-State)|The STAI-State is a 20-item self report scale employing a Likert scale format with 4 responses per item (1-4). The possible range of scores is from 20-80, and higher scores indicate greater levels of anxiety.Ten of the STAI items measure feelings of stress and anxiety, while the remaining ten items measure feelings of relaxation.|post-treatment (9 weeks)||||units on a scale||Standard Deviation|Mean
2655661|NCT01623830|Secondary|The Beck Depression Inventory (BDI)|a 21-item measure of cognitive and vegetative symptoms of depression is widely used in a variety of populations, including trauma victims and is sensitive to treatment effects on depression. The possible range for scores is 0-63 with higher scores suggesting more severe symptoms of depression.|post-treatment (9 weeks)||||units on a scale||Standard Deviation|Mean
2655662|NCT01623830|Primary|The Questionnaire on Attitudes Toward Flying (QAF)|assesses history of FOF, previous treatment, and attitudes toward flying. It includes a 36-item questionnaire rating the level of fear on an 11-point scale ranging from 0 to10 in different flying situations. The possible range of scores is 0 to 360 with higher scores indicating greater fear associated with flying. Test-retest reliability was .92, and split-half reliability was .99.|post treatment (9 weeks)||||units on a scale||Standard Deviation|Mean
2655663|NCT01623830|Primary|Fear of Flying Inventory (FFI)|a 33-item scale measuring intensity of FOF. Items are rated on a 9-point scale ranging from 0 ( not at all) to 8 ( very severely disturbing). The possible range of scores is 0-264 with higher total scores indicating greater fear of flying intensity.Test-retest reliability for 15 WL patients was .92, and it has been sensitive to change with treatment.|Post treatment (9 weeks)||||units on a scale||Standard Deviation|Mean
2655664|NCT01623752|Other Pre-specified|Number of Participants Who Used Concomitant Medication|Number of participants who used medication other than Etanercept for relief of pain. It was determined by the treating physician.|Baseline up to Week 156|Safety analysis set included all patients who received at least 1 dose of Etanercept.|||Participants|||Count of Participants
2655666|NCT01623752|Other Pre-specified|Number of Participants With Results of Tolerability Assessment by Physician and Participant|Physicians and participants rated the tolerability of Etanercept treatment by means of a 4-point scale as: 1) very good, 2) good, 3) moderate and 4) insufficient.|Week 78, 156|"Safety analysis set included all patients who received at least 1 dose of Etanercept. Here, Number Analyzed signifies number of participants evaluable for specified rows."|||Participants|||Count of Participants
2655667|NCT01623752|Other Pre-specified|Number of Participants With Treatment-Emergent Treatment Related Adverse Events|Treatment-related AE was any untoward medical occurrence in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. Relatedness to study treatment was assessed by the investigator.|Baseline up to Week 156|"Safety analysis set included all patients who received at least 1 dose of Etanercept. Here, Overall Number of Participants Analyzed signifies number of participants who had at least 1 treatment AE."|||Participants|||Count of Participants
2655668|NCT01623752|Other Pre-specified|Number of Participants With Discontinuation of Etanercept Treatment|Number of participants those who discontinued Etanercept treatment at Week 78 and 156 are reported in this outcome measure.|Week 78, 156|"Safety analysis set included all patients who received at least 1 dose of Etanercept. Here, Number Analyzed signifies number of participants evaluable for specified time points."|||Participants|||Count of Participants
2655669|NCT01623752|Other Pre-specified|Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. AEs were classified according to the severity in 3 categories a)mild: AEs not interfered with participant's usual function b)moderate: AEs interfered to some extent with participant's usual function c)severe: AEs interfered significantly with participant's usual function. Participants may be counted in more than 1 category.|Baseline up to Week 156|"Safety analysis set included all patients who received at least 1 dose of Etanercept. Here, Overall Number of Participants Analyzed signifies number of participants who had at least 1 treatment AE."|||Participants|||Count of Participants
2655670|NCT01623752|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Baseline up to Week 156|Safety analysis set included all patients who received at least 1 dose of Etanercept.|||Participants|||Count of Participants
2655671|NCT01623752|Secondary|Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D)|"In this outcome number of participants who participated or not participated in RUDI and PIT and impact of their participation in quality of life parameters using EQ-5D health questionnaire is reported. For participants whom data was not recorded is reported under category No Data. EQ-5D: participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem."|Baseline up to Week 156|Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, “Overall Number of participants analyzed” = number of participants evaluable for this measure and “Number Analyzed” = number of participants evaluable for the specified rows.|||Participants|||Count of Participants
2655672|NCT01623752|Secondary|Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept|"In this outcome number of participants who participated or not participated in RUDI and PIT and impact of their participation in continuation or termination of treatment with Etanercept is reported. For participants whom data was not recorded is reported under category No Data."|Baseline up to Week 156|Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, “Overall Number of participants analyzed” = number of participants evaluable for this measure and “Number Analyzed” = number of participants evaluable for the specified rows.|||Participants|||Count of Participants
2655673|NCT01623752|Secondary|Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156)|"In this outcome measure number of participants with use of glucocorticoids and DMARDs at baseline and specified weeks are reported. If participants used glucocorticoids and DMARDs, it was denoted by Yes and if they did not use, it was denoted by No. Data have been reported separately for glucocorticoids and DMARDs at specified weeks respectively, in 4 categories as: 1) Baseline: No and Specified Week: No, 2) Baseline: Yes and Specified Week: No, 3) Baseline: No and Specified Week: Yes, 4) Baseline: Yes and Specified Week: Yes."|Baseline, Week 78, 156|Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, “Number Analyzed” = number of participants evaluable for the specified rows.|||Participants|||Count of Participants
2655674|NCT01623752|Secondary|Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis|In this outcome measure change in number of inflamed dactylitic digits at specified week compared to baseline is reported. Dactylitis is inflammation of dactylitic digits (fingers and toes).|Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156|Full analysis set. Here, “Number Analyzed” signifies number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with psoriatic arthritis.|||Dactylitic digits||Standard Deviation|Mean
2655675|NCT01623752|Secondary|Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis|In this outcome measure change in number of nails affected by psoriatic arthritis at specified week compared to baseline is reported. Nails included both finger nails and toe nails.|Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156|Full analysis set. Here, “Number Analyzed” signifies number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with psoriatic arthritis.|||Nails||Standard Deviation|Mean
2655676|NCT01623752|Secondary|Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis|Participants with psoriatic arthritis were distributed in following different classes depending upon percentage (%) of BSA affected: 1) less than (<) 3 %, 2) 3-10%, 3) 11-20% and 4) >20%. Psoriatic arthritis affecting <3% BSA was considered as mild, 3 to 10 % as moderate and >10 percent as severe.|Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156|Full analysis set. Here, “Number Analyzed” signifies number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with psoriatic arthritis.|||Participants|||Count of Participants
2655677|NCT01623752|Secondary|Duration of Morning Stiffness in Participants With Temporary Rigidity|Rigidity was temporary when 'Yes' was given for the question if daily activities could be done without stiffness; rigidity was permanent when 'No' was given for the question if daily activities could be done without stiffness.|Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156|Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, “Number Analyzed” signifies number of participants evaluable for the specified time points.|||Hours||Full Range|Median
2655678|NCT01623752|Secondary|Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D)|EQ-5D: participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem.|Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156|Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, “Number Analyzed” signifies number of participants evaluable for the specified rows.|||Participants|||Count of Participants
2655679|NCT01623752|Secondary|Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156|PtGA: participant assessed their disease activity using a 100 mm visual analog scale ranging from 0 = very good to 100 = worst. Higher scores indicate worse health status.|Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156|Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, “Number Analyzed” signifies number of participants evaluable for the specified time points.|||millimeter||Standard Deviation|Mean
2655680|NCT01623752|Secondary|Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156|PhyGA: physician marked intensity of participants' pain on a visual analogue scale of 0 (no disease activity) to 100 mm (worst possible condition). Higher scores indicate greater level of disease activity.|Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156|Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, “Number Analyzed” signifies number of participants evaluable for the specified time points.|||millimeter||Standard Deviation|Mean
2655681|NCT01623752|Secondary|Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156|VAS: participants placed a mark indicating the intensity of their pain on a scale of 0 (no pain) to 100 mm (worst possible pain). Higher scores indicate greater level of pain.|Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156|Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, “Number Analyzed” signifies number of participants evaluable for the specified time points.|||millimeter||Standard Deviation|Mean
2655682|NCT01623752|Secondary|Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI)|CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and PhyGA. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=10 indicates low disease activity and a score of <= 2.8 indicates remission. SDAI was calculated from tender and swollen joints using 28 joint count, PtGA, PhyGA and CRP (in mg/L). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=11 indicates low disease activity and a score of <=3.3 indicates remission. PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity.|Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156|Full analysis set. Here, “Overall Number of Participants Analyzed” = number of participants evaluable for this outcome measure and “Number Analyzed” = number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with rheumatoid arthritis.|||Percentage of participants|||Number
2655706|NCT01623739|Secondary|Probing Depth|The measurement of the pocket around the implanted tooth, measured with a graduated probe. A healthy pocket depth is around 3mm with no bleeding during the measurement process. The values are totaled and a mean score of all the readings is reported.|3, 6, 12, 24, 36, 48, 60 months after crown delivery||||mm||Standard Error|Mean
2655683|NCT01623752|Secondary|Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI)|CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and PhyGA. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=10 indicates low disease activity and a score of <= 2.8 indicates remission. SDAI was calculated from tender and swollen joints using 28 joint count, PtGA, PhyGA and CRP (in mg/L). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=11 indicates low disease activity and a score of <=3.3 indicates remission. PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity.|Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156|Full analysis set: all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. “Number Analyzed” = number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with rheumatoid arthritis.|||Percentage of participants|||Number
2655684|NCT01623752|Secondary|Change From Baseline in Simple Disease Activity Index (SDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis|SDAI was calculated from tender and swollen joints using 28 joint count, participant global assessment (PtGA), physician global assessment and (PhyGA) and CRP (in mg/L). PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=11 indicates low disease activity and a score of <=3.3 indicates remission.|Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156|Full analysis set: all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. “Number Analyzed” = number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with rheumatoid arthritis.|||Units on a scale||Standard Deviation|Mean
2655685|NCT01623752|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis|CDAI was calculated from tender and swollen joints using 28 joint count, participant global assessment (PtGA) and physician global assessment (PhyGA). PtGA and PhyGA both were assessed on 0-100 mm VAS scale, where higher scores indicated greater affection due to disease activity. CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=10 indicates low disease activity and a score of <= 2.8 indicates remission.|Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156|Full analysis set: all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. “Number Analyzed” = number of participants evaluable for the specified time points. Data for this outcome measure was to be collected and evaluated only for participants with rheumatoid arthritis.|||Units on a scale||Standard Deviation|Mean
2655686|NCT01623752|Secondary|Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156|DAS28 was calculated from swollen joint count and tender joint count using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PtGA) of disease activity measured on a 100 mm visual analog scale (VAS) ranging from 0 (good condition) to 100 (worst condition), where higher scores indicate worse health condition). DAS28 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS-28 score of 2.6 to 3.2= low, 3.2 to 5.1= moderate and >5.1= high disease activity. DAS-28 score of <2.6= disease remission. DAS28-4(CRP) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.36*ln[CRP+1]) + 0.014*GH + 0.96) and DAS28-4(ESR) = (0.56*sqrt[TJC28] + 0.28*sqrt[SJC28] + 0.70*ln[ESR] + 0.014*GH), where sqrt = square root, ln = natural logarithm.|Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156|Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, “Number Analyzed” signifies number of participants evaluable for the specified time points.|||Units on a scale||Standard Deviation|Mean
2655687|NCT01623752|Secondary|Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156|"FFbH is a self-administered patient questionnaire composed by 18 questions on functional ability in activities of daily living. Each question was answered by the participant as Yes, I can perform the activity without difficulty (score assigned =2), Yes, but with difficulties (score assigned =1) and No or only with external help (score assigned =0). Final FFbH score (%) was then computed according to formula: (Sum of scores*100) divided by (2*number of valid answers), ranging between 0 (no functional capacity) to 100 (full functional capacity); higher scores indicate better daily activities. FFbH functional remission was defined as FFbH functional capacity of >= 83%."|Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156|Full analysis set included all participants who received at least 1 dose of Etanercept and had at least 1 effectiveness measurement after start of treatment. Here, “Number Analyzed” signifies number of participants evaluable for the specified time points.|||Units on a scale||Standard Deviation|Mean
2655688|NCT01623752|Secondary|Change From Baseline in Total Joint Space Narrow Score at End of Phase 1 (Week 78) and Phase 2 (Week 156)|Total joint space narrow score as per van der Hejde method consisted of 2 dimensions: a) hands (30 joint space locations, each location graded from 0 [normal joint space] to 4 [bony ankylosis], sum of grading of each location resulted in score of 0 to 120); and b) feet (12 erosion locations, each location graded from 0 [no erosion] to 4 [bony ankylosis], sum of grading of each location resulted in score of 0 to 48). Sum of joint space narrow scores of hand (0 to 120) and feet (0 to 48) gave a total joint space narrow score as 0 to 168, where 0 was normal joint space and 168 was maximum narrowing in joints, higher scores indicated severe joint destruction.|Baseline, Week 78, 156|Efficacy analysis set included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2 or have Rx1 and Rx3. Here, “Overall Number of Participants Analyzed” = number of participants evaluable for this outcome measure and “Number Analyzed” = number of participants evaluable for the specified time points.|||Units on a scale||Standard Deviation|Mean
2655739|NCT01623115|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2655689|NCT01623752|Secondary|Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156)|Total erosion score as per van der Hejde method consisted of 2 dimensions: a) hands (32 erosion locations, each location graded from 0 [no erosion] to 5 [maximum severity], sum of grading of each location resulted in score of 0 to 160); and b) feet (12 erosion locations, each location graded from 0 [no erosion] to 10 [maximum severity], sum of grading of each location resulted in score of 0 to 120). Sum of erosion scores of hand (0 to 160) and feet (0 to 120) gave a total erosion score as 0 to 280, where 0 was no erosion at all and 280 was worst possible condition, higher scores indicated severe joint destruction.|Baseline, Week 78, 156|Efficacy analysis set included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2 or had Rx1 and Rx3. Here, “Overall Number of Participants Analyzed” = number of participants evaluable for this outcome measure and “Number Analyzed” = number of participants evaluable for the specified time points.|||Units on a scale||Standard Deviation|Mean
2655690|NCT01623752|Secondary|Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28)|Effect on radiographic progression with respect to baseline DAS-28 was evaluated using ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was baseline DAS-28. Baseline DAS-28 is less than or equal to (<=) 5.1 or >5.1. DAS28: score range from 0 (none) to 9.4 (extreme disease activity); low =2.6 to 3.2, moderate =3.2 to 5.1, and high disease activity >5.1. DAS28 score of <2.6 indicates disease remission.|Baseline up to Week 78|Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, “Overall Number of Participants Analyzed” = number of participants evaluable for this outcome measure and “Number Analyzed” = number of participants evaluable for the specified rows.|||Scores per year||95% Confidence Interval|Least Squares Mean
2655691|NCT01623752|Secondary|Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics|Effect on normalized radiographic progression of previous treatment with biologics was evaluated using an ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was previous treatment with biologics.|Baseline up to Week 78|Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, “Overall Number of Participants Analyzed” = number of participants evaluable for this outcome measure and “Number Analyzed” = number of participants evaluable for the specified rows.|||Scores per year||95% Confidence Interval|Least Squares Mean
2655692|NCT01623752|Secondary|Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication|Effect on normalized radiographic progression with respect to use of concomitant medication at baseline was evaluated using an ANOVA model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was groups of concomitant medication as found among the medication given concomitantly during study that is recorded at baseline.|Baseline up to Week 78|Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, “Overall Number of Participants Analyzed” = number of participants evaluable for this outcome measure and “Number Analyzed” = number of participants evaluable for the specified rows.|||Scores per year||95% Confidence Interval|Least Squares Mean
2655693|NCT01623752|Secondary|Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF)|Effect on normalized radiographic progression with respect to ACPA-RF was evaluated using an analysis of variance (ANOVA) model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was groups of positive testing of ACPA and RF at baseline.|Baseline up to Week 78|Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, “Overall Number of Participants Analyzed” = number of participants evaluable for this outcome measure and “Number Analyzed” = number of participants evaluable for the specified rows.|||Scores per year||95% Confidence Interval|Least Squares Mean
2655694|NCT01623752|Secondary|Linear Relationship Between Normalized Radiographic Progression and Disease Duration|Linear relationship between radiographic progression and disease duration was evaluated using a linear regression model. Dependent variable was normalized progression under treatment with Etanercept and independent variable was disease duration.|Baseline up to Week 78|Efficacy analysis set for Phase 1 included participants who received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, “Overall Number of Participants Analyzed” signifies number of participants evaluable for this outcome measure.|||Regression coefficient|||Number
2655695|NCT01623752|Primary|Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at the End of Phase 2 (Week 156): CAS|The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (>0.5), no change (-0.5 to 0.5) and decrease (<-0.5). Participants with no change or a decrease were considered to be in radiographic remission.|Pre-treatment, Week 156|CAS for phase 2 included all participants who had received at least 1 dose of Etanercept, and had Rx1 and Rx2, and completed phase 2 of the study. Here, “Overall Number of Participants Analyzed” signifies number of participants evaluable for this outcome measure.|||Scores per year||Standard Deviation|Mean
2655696|NCT01623752|Primary|Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 2 (Week 156): EAS|The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (>0.5), no change (-0.5 to 0.5) and decrease (<-0.5). Participants with no change or a decrease were considered to be in radiographic remission.|Pre-treatment, Week 156|Efficacy analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept and had Rx1 and Rx3. Here, “Overall Number of Participants Analyzed” signifies number of participants evaluable for this outcome measure.|||Scores per year||Standard Deviation|Mean
2655707|NCT01623739|Secondary|PES/WES (Pink Esthetic Score, White Esthetic Score).|The PES and WES scales are 10 point scales, made up of 5 categories, each with a 2 point value. Each category is scored out of 2, and the scores totaled to give an optimal score out of 10. Any score of 6 or higher out of 10 would be considered a good clinical outcome. the PES categories focus on the gum area, and the WES categories focus on the tooth. The scores for PES and WES are totaled, to give a score out of 20, with 20 being the highest possible score (best outcome). The values are totaled and a mean score of all the readings is reported.|3, 6, 12, 24, 36, 48, 60 months after crown delivery||||units on a scale||Standard Error|Mean
2655697|NCT01623752|Primary|Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS|The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (>0.5), no change (-0.5 to 0.5) and decrease (<-0.5). Participants with no change or a decrease were considered to be in radiographic remission.|Pre-treatment, Week 78|CAS for phase 1 included all participants who had received at least 1 dose of Etanercept, and had Rx1 and Rx2, and provided data for end of Phase 1 of study. Here, “Overall Number of Participants Analyzed”=number of participants evaluable for this outcome measure and “Number Analyzed”=number of participants evaluable for the specified time points.|||Scores per year||Standard Deviation|Mean
2655698|NCT01623752|Primary|Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS|The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (greater than [>] 0.5), no change (-0.5 to 0.5) and decrease (less than [<] -0.5). Participants with no change or a decrease were considered to be in radiographic remission.|Pre-treatment, Week 78|Efficacy analysis set for Phase 1 included all participants who had received at least 1 dose of Etanercept and had Rx1 and Rx2. Here, “Overall Number of Participants Analyzed” = number of participants evaluable for this outcome measure and “Number Analyzed” = number of participants evaluable for the specified time points.|||Scores per year||Standard Deviation|Mean
2655699|NCT01623752|Primary|Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 2 (Week 156): CAS|To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.|Baseline, Week 156|Completer analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept, and had clinical data for the obligatory X-ray (Rx1) and Rx3, and completed Phase 2 of the study. Here, “Overall Number of Participants Analyzed” signifies number of participants evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2655700|NCT01623752|Primary|Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS|To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.|Baseline, Week 156|Efficacy analysis set for Phase 2 included all participants who had received at least 1 dose of Etanercept and had Rx1 and end of Phase 2 X-ray (Rx3). Here, “Overall Number of Participants Analyzed” signifies number of participants evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2655701|NCT01623752|Primary|Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS)|To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.|Baseline, Week 78|Completer analysis set for Phase 1: all participants who had received at least 1 dose of Etanercept and had clinical data for Rx1 and Rx2 and provided data for end of Phase 1 of study. “Overall Number of Participants Analyzed” = participants evaluable for this outcome measure. “Number Analyzed”= participants evaluable for the specified time points.|||Units on a scale||Standard Deviation|Mean
2655702|NCT01623752|Primary|Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS)|To assess radiological damage mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.|Baseline, Week 78|Efficacy analysis set for Phase 1= all participants who had received at least 1 dose of Etanercept and had baseline X-ray (Rx1) and end of phase 1 X-ray (Rx2). Here, “Overall Number of Participants Analyzed” =number of participants evaluable for this outcome measure; “Number Analyzed”=number of participants evaluable for the specified time points.|||Units on a scale||Standard Deviation|Mean
2655703|NCT01623739|Secondary|Radiographic Bone Level|Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.|Up to 5 years after baseline|No data were collected or analyzed for this outcome measure||||||
2655704|NCT01623739|Secondary|Modified Bleeding Index|Bleeding from the gums is measured on probing the gum and measured on scale of 0 to 5, with 0 being the best outcome, with no bleeding, and 5 being the worst outcome, with spontaneous bleeding. The scores are totaled and a mean score reported.|3, 6, 12, 24, 36, 48, 60 months after crown delivery||||units on a scale||Standard Error|Mean
2655705|NCT01623739|Secondary|Modified Plaque Index|Measurement of amount of plaque build-up on teeth, using a scale of 0 (no plaque detection), to 3 (an abundance of soft matter). The scores are totaled and a mean score reported.|3, 6, 12, 24, 36, 48, 60 months after crown delivery||||units on a scale||Standard Error|Mean
2655708|NCT01623739|Primary|Mid Facial Mucosal Level at Implant Site|Baseline will be at the time of crown delivery. Thereafter, the mid facial mucosal level at implant site will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.|3 months after crown delivery||||mm||Standard Deviation|Mean
2655709|NCT01623596|Secondary|Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score|"Summary statistics for Medication Satisfaction Questionnaire[Question: Overall, how satisfied are you with your current medication?] (Randomized treatment / randomized phase): Fingolimod vs MS-DMT"|Baseline, 1 month, 3 months, 6 months, 9 months, at 12 months & Last assessment during randomized phase which is either at Month 12 or at early discontinuation|Full analysis set (FAS) includes all the patients who received at least one dose of study medication and had information on the primary end point.|||participants|||Number
2655710|NCT01623596|Secondary|Percent Change From Baseline in Brain Volume From Month 12 to Last Visit (Randomized)|Summary statistics for percent change from month 12 in brain volume by visit (Randomized treatment / randomized phase) in patients treated with fingolimod vs.DMTs as measured by MRI|12 months, and Last assessment which is either at Month 12 or at early discontinuation|Full analysis set includes all the patients who received at least one dose of study medication and had information on the primary end point.|||percent change in brain volume||Standard Deviation|Mean
2655711|NCT01623596|Secondary|Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Written Test) by Visit (Randomized Treatment / Randomized Phase)|"Summary statistics Compare cognitive impairment measured by Symbol Digit Modalities Test (SDMT) scores. The SDMT score and its change from baseline value were summarized by visit. For the change from baseline values at each visit, ANCOVA adjusted for treatment naivety, corresponding baseline values, and age was performed for treatment comparisons~The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.~NOTE: Higher scores indicate better performance."|baseline, 6 months, 12 months, Last assessment which is either at Month 12 or at early discontinuation|Full analysis set includes all the patients who received at least one dose of study medication and had information on the primary end point.|||SDMT score||Standard Deviation|Mean
2655712|NCT01623596|Secondary|Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Oral Test) by Visit (Randomized Treatment / Randomized Phase)|"Summary statistics Compare cognitive impairment measured by Symbol Digit Modalities Test (SDMT) scores. The SDMT score and its change from baseline value were summarized by visit. For the change from baseline values at each visit, ANCOVA adjusted for treatment naivety, corresponding baseline values, and age was performed for treatment comparisons~The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.~NOTE: Higher scores indicate better performance."|baseline, 6 months, 12 months, and Last assessment which is either at Month 12 or at early discontinuation|Full analysis set includes all the patients who received at least one dose of study medication and had information on the primary end point.|||SDMT score||Standard Deviation|Mean
2655713|NCT01623596|Secondary|Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set|"Reasons for discontinuation in participants treated with fingolimod vs. DMT over 12 months of treatment~Total discontinued (Primary reason): Fingolimod arm: 27, MS-DMT arm: 27 = 54 participants~Total discontinued (Secondary reason): Fingolimod arm: 257, MS-DMT arm: 256 = 513 participants~Throughout the study, investigators evaluated each patient for occurrence of randomized treatment discontinuation and determined the primary and secondary reasons for such discontinuation. At every visit, the investigator evaluated the patients and determined if they should continue on randomized treatment or change to alternative treatment. Treatment discontinuation was a clinically meaningful measure related to safety, efficacy, and tolerability over time, reflecting the therapeutic effectiveness of study treatment."|at 12 months|"Randomized set (RS): consists of all patients who were assigned randomization numbers.~The patients in this set were called randomized patients. This set was used to summarize patient disposition, demographic and baseline characteristics, and protocol deviation information. Patients were grouped according to randomized treatment."|||participants|||Number
2655714|NCT01623596|Primary|Participant Retention Rate Over 12 Months|Comparison effectiveness of fingolimod versus approved first-line disease modifying therapies by measuring the rate of participant retention on randomized treatment over a 12-month period (Full analysis set)|at 12 months|Full analysis set includes all the patients who received at least one dose of study medication and had information on the primary end point.|||participants|||Number
2655715|NCT01623479|Secondary|Percentage of Subjects Satisfied Wtih Their Eyelashes|Overall subject satisfaction with their eyelashes was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported.|Day 1|Subjects with all study data|||Percentage of Subjects|||Number
2655716|NCT01623479|Secondary|Number of Applications of Latisse® Per Week|Number of applications of Latisse® per week as reported by the subjects.|Day 1|Subjects with all study data|||Number of Applications||Standard Deviation|Mean
2655717|NCT01623479|Primary|Percentage of Subjects Satisfied With Latisse®|Overall subject satisfaction with Latisse® was assessed on a 5-point scale (Very Satisfied, Satisfied, Neutral, Unsatisfied, and Very Unsatisfied). The percentage of subjects satisfied and very satisfied is reported.|Day 1|Subjects with all study data|||Percentage of Subjects|||Number
2655718|NCT01623466|Primary|Cycle Control|Measurement of unscheduled bleeding/spotting days.|8 weeks|Completed subjects|||days||Standard Deviation|Mean
2655719|NCT01623466|Primary|Evaluation of Itching at Patch Application Site|"Self-reported worst skin itching at patch application site by subject using a 4-point scale:~0. None~Mild~Moderate~Severe"|8 weeks|Safety Population|||Score||Standard Deviation|Mean
2655720|NCT01623466|Primary|Evaluation of Irritation at Patch Application Site|"Self-reported worst skin irritation score at patch application site for each subject using a 4-point irritation scale:~0: None~Mild~Moderate~Severe"|8 weeks|Safety population|||Score on a scale||Standard Deviation|Mean
2655721|NCT01623466|Primary|Evaluation of Patch Adhesion|"Evaluation of worst patch adhesion score for each subject using a 5-point adhesion scale:~0: ≥90% adhered (no lift)~≥75% adhered but <90% (some edges showing lift)~≥50% adhered but <75% (half of system lifts off)~<50% (< half of system lifts off, but undetached)~patch completely detached"|8 weeks|Safety population|||Score on a scale||Standard Deviation|Mean
2655725|NCT01623310|Secondary|Summed Bilateral Nasal Polyp Grading Scale Score|"In subjects with nasal polyps, polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy.~0: No polyps~Mild polyposis: polyps not reaching below the inferior of the middle turbinate~Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate~Severe polyposis: large polyps reaching below the lower inferior border of the inferior turbinate"|Baseline, Month 3, Month 12|Includes Chronic Sinusitis with Nasal Polyp Patients|||units on a scale||Standard Deviation|Mean
2655726|NCT01623310|Secondary|Patient Global Impression of Change (PGIC)|"The PGIC took less than 1 minute to complete. Subjects answered question, Since starting the study drug, how would you rate the change in your symptoms? Patients may answer very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse. Data listed below reports the total number of patients who answered very much improved, much improved, or minimally improved at the specified time."|Baseline, Month 3, Month 12|The Safety Analysis Set included all subjects who received at least 1 dose of study drug.|||Participants|||Count of Participants
2655727|NCT01623310|Secondary|Lund-Mackay Total Score|"Change from baseline to Month 3, Month 12, in Lund-Mackay Total Score~Lund-Mackay Assessment of nasal cavity appearance, via nasoendoscopy, used to evaluate signs of edema, discharge, crusting, scarring/adhesions, and nasal polyps, with each sign rated on a 0 to 2 scale 0: None 2: Worse outcome"|Baseline, Month 3, Month 12|The Safety Analysis Set included all subjects who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2655728|NCT01623310|Secondary|Sinonasal Outcome Test 22 (SNOT-22) Total Score|"Change from baseline to Month 3 & Month 12 in SNOT-22 Total Score~SNOT-22 is validated in large populations with chronic sinusitis with and without nasal polyps. The 22 questions are used to calculate a total score (the sum of all items) and 4 subscale scores. The 22 questions are divided among 4 subscales: Rhinologic, Ear and Facial Symptoms, Sleep Function, and Psychological Issues subscales. The total score can range from 0-110, 0 being the best and 110 being the worst.~0: No problem~Very mild problem~Mild or slight problem~Moderate problem~Severe problem~Problem as bad as it can be"|Baseline, Month 3, Month 12|The Safety Analysis Set included all subjects who received at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2655729|NCT01623310|Primary|Adverse Events|Patients with at least one Adverse Events|12 Months||||Participants|||Count of Participants
2655730|NCT01623271|Primary|Visual Analog Scale (VAS) at Visit 3|Subjects rated their pain using the VAS at visit 3, which was the last day of their maintenance phase. After this visit, subjects begin to taper the gralise. The VAS is subject reported on a scale of 0-10 with 0 being no pain and 10 being the worst pain they can imagine. Results reported are an average of the 3 subjects who completed visit 3.|At visit 3|Only 3 subjects completed visit 3. The other 2 subjects dropped out due to expected side effects.|||units on the VAS||Standard Deviation|Mean
2655731|NCT01623154|Other Pre-specified|Number of Participants Tested Positive/Negative for H. Pylori|"Qualified subjects from clinical sites underwent a standard urea breath test using the BreathTek UBT Kit. Breath samples were analyzed using both the POCone and the UBiT-IR300. DOB values from these two infrared spectrophotometers were converted to respective UHR values using pUHR-CA. The paired UHR values from each subject were evaluated for agreement.~UHR values of >10 µg/min were considered positive for H. pylori and UHR values of <10 µg/min were considered negative for H. pylori."|Single Study Visit (1 hour of testing)|95 evaluable subjects for initial diagnosis - each patient received the BreathTek UBT test. Collected breath samples were analyzed on both the UBiT-IR300 and the POC-one.|||Participants|||Number
2655732|NCT01623154|Primary|Agreement Between POCone and UBiT-IR300.|"The study end-points are UHR values derived from DOB (delta over baseline) values obtained from the POCone and UBiT-IR300 (UHRP and UHRU, respectively) at Baseline and Post-Dose. Same patients will be tested on both the POCone and UBiT-IR300.~Subjects fasted for at least 1 hr prior test. Each patient provided breath samples in 3 blue (Baseline) breath bags-labeled A B C. Subjects were given Pranactin-Citric solution (4oz) to drink, waited 15 min and collected 3 pink (post-dose) bags which were paired with the baseline bags in no particular order. Each pair was tested on both machines. The first two available pairs of UHR values were used for data analysis. The 3rd pair was used only if one of the first two samples did not produce a valid test result.~DOB values were generated by the two instruments for each Baseline and Post Dose pair. UHR values were claculated based on the DOB values and the subject's anthropometric variables (age, gender, ehight and body weight)."|Baseline, Post Dose (15 min)|Evaluable patients must drink all of the Pranactin-citric solution. Though all three sets of bags were analysed, the first two sets of valid values were used for analysis, regardless of the set designation (A, B or C). The values of individual sets (A, B or C) were not analyzed.|||||95% Confidence Interval|Number
2655733|NCT01623115|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 78 (i.e. up to 21 days after last injection).|From Baseline to Week 78|mITT population.|||percent change||Standard Error|Least Squares Mean
2655734|NCT01623115|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis|Adjusted LS means and standard errors at Week 78 from MMRM including all available post-baseline data from Week 4 to Week 78 regardless of status on-or off-treatment.|From Baseline to Week 78|ITT population.|||percent change||Standard Error|Least Squares Mean
2655735|NCT01623115|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.|||percent change||Standard Error|Least Squares Mean
2655736|NCT01623115|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.|||percent change||Standard Error|Least Squares Mean
2655737|NCT01623115|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2655740|NCT01623115|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).|||percent change||Standard Error|Least Squares Mean
2655741|NCT01623115|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2655742|NCT01623115|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2655743|NCT01623115|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2655744|NCT01623115|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.|||percentage of participants|||Number
2655745|NCT01623115|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|Up to Week 52|ITT population.|||percentage of participants|||Number
2655746|NCT01623115|Secondary|Percentage of Very High CV Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - On- Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.|||percentage of participants|||Number
2655747|NCT01623115|Secondary|Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis|Very high CV risk participants: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents. High CV risk participants: heFH participants without CHD or CHD risk equivalents. CHD risk equivalent: peripheral arterial disease, ischemic stroke, moderate chronic kidney disease (estimated glomerular filtration rate, 30 to <60 ml/minute/1.73 m^2 of body-surface area), or diabetes mellitus plus 2 or more additional risk factors (hypertension; ankle-brachial index of ≤0.90; microalbuminuria, macroalbuminuria, or a urinary dipstick result of >2+ protein; preproliferative or proliferative retinopathy or laser treatment for retinopathy; or a family history of premature CHD). Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.|||percentage of participants|||Number
2655748|NCT01623115|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
2655749|NCT01623115|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
2655750|NCT01623115|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2655751|NCT01623115|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
2655752|NCT01623115|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on-or off-treatment (Total-C ITT population).|||percent change||Standard Error|Least Squares Mean
2655753|NCT01623115|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL­C value on-treatment (non-HDL-C mITT population).|||percent change||Standard Error|Least Squares Mean
2655754|NCT01623115|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2655755|NCT01623115|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo B mITT population).|||percent change||Standard Error|Least Squares Mean
2655756|NCT01623115|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).|||percent change||Standard Error|Least Squares Mean
2655757|NCT01623115|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.|||percent change||Standard Error|Least Squares Mean
2655758|NCT01623115|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
2655759|NCT01623115|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2655760|NCT01623115|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on­ or off-treatment.|||percent change||Standard Error|Least Squares Mean
2655761|NCT01623050|Secondary|Patency of Treated Area|Maxillary Sinus Ostia of 27 patients analyzed.|12 months|7 patients were lost to follow up|||percentage of ostia patent|Participants||Number
2655762|NCT01623050|Secondary|Patency of Treated Area|Maxillary Sinus Ostia Patency of 29 patients analyzed.|6 months|5 patients were lost to follow up|||percentage of ostia patent|Participants||Number
2655763|NCT01623050|Secondary|Number of Participants With Device-related Adverse Events as a Measure of Safety||3 months||||number of participants|||Number
2655764|NCT01623050|Secondary|Patency of Treated Area|Maxillary Sinus Ostia Patency of 33 patients analyzed.|3 months|One patient was lost to follow up|||percentage of ostia patent|Participants||Number
2655765|NCT01623050|Primary|Patency of Treated Area||Immediately post procedure|Number of osita treated|||percentage of ostia treated|Participants||Number
2655766|NCT01622699|Secondary|Number of Patients Having Kernicterus|Kernicterus is a very rare condition. As it is a possible complication of neonatal hyperbilirubinemia, it's an outcome measure.|up to 1 year||||Participants|||Count of Participants
2655767|NCT01622699|Secondary|Highest Measured Serum Bilirubin-value||up to 1 year||||micromol/l||Standard Deviation|Mean
2655768|NCT01622699|Secondary|Number of Patients With Serum Bilirubin-values Above the 'Exchange Transfusion Limit'||up to 1 year||||Participants|||Count of Participants
2655769|NCT01622699|Primary|Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy).||up to 1 year||||blood tests for bilirubin||Inter-Quartile Range|Median
2655770|NCT01622673|Primary|Number of Participants With Any Clinical or Laboratory Adverse Event (AE)|"An AE is defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience."|Up to 7 days after the last dose of study drug|All subjects who received any amount of the study drug were included in the safety population|||participants|||Number
2655771|NCT01622673|Primary|Mean Time to Maximum Plasma Concentration (Tmax) of Raltegravir|Participant blood samples were collected to measure the time to achieve the maximum steady state plasma concentration of raltegravir when administered alone or with a single dose of antacid|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics|||hr||Standard Deviation|Mean
2655772|NCT01622673|Primary|Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)|Participant blood samples were collected to measure the maximum steady state plasma concentration of raltegravir after administration alone or before or after a single dose of antiacid. The secondary hypothesis compared Cmax of raltegravir when administered alone with Cmax of raltegravir when administered 2 hours before or after MINTOX®.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics|||nM||95% Confidence Interval|Least Squares Mean
2655773|NCT01622673|Primary|Least Squares Mean Maximum Plasma Concentration (Cmax) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)|Participant blood samples were collected to measure the steady state maximum plasma concentration of raltegravir when administered alone or with a single dose of antacid. The primary hypothesis compared Cmax of raltegravir when administered alone with Cmax of raltegravir when coadministered with TUMS® or MINTOX®.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics|||nM||95% Confidence Interval|Least Squares Mean
2655774|NCT01622673|Primary|Least Squares Mean Steady State Area Under the Plasma Concentration-Time (AUC0-12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)|Participant blood samples were collected to measure the steady state AUC of raltegravir up to 12 hours after administration alone or before or after a single dose of antacid. The secondary hypothesis compared AUC0-12hrs of raltegravir when administered alone with AUC0-12hrs of raltegravir when administered 2 hours before or after MINTOX®.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics|||nM*hr||95% Confidence Interval|Least Squares Mean
2655775|NCT01622673|Primary|Least Squares Mean Steady State Area Under the Plasma Concentration-time Curve (AUC0-12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)|Participant blood samples were collected to measure the steady state AUC of raltegravir up to 12 hours after administration alone or with a single dose of antacid. The primary hypothesis compared AUC0-12hrs of raltegravir when administered alone with AUC0-12hrs of raltegravir when coadministered with TUMS® or MINTOX®.|Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics|||nM*hr||95% Confidence Interval|Least Squares Mean
2655776|NCT01622673|Primary|Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Staggered Administration of Antacid (Secondary Hypothesis)|Participant blood samples were collected to measure the steady state plasma concentration of raltegravir 12 hours after administration alone or before or after a single dose of antacid. The secondary hypothesis compared C12hrs of raltegravir when administered alone with C12hrs of raltegravir when administered 2 hours before or after MINTOX®.|12 hours postdose|All participants were included for whom at least one PK parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics|||nM||95% Confidence Interval|Least Squares Mean
2655777|NCT01622673|Primary|Least Squares Mean Steady State Plasma Concentration (C12hrs) of Raltegravir After Coadministration of Antacid (Primary Hypothesis)|Participant blood samples were collected to measure the steady state plasma concentration of raltegravir 12 hours after administration alone or with a single dose of antacid. The primary hypothesis compared C12hrs of raltegravir when administered alone with C12hrs of raltegravir when coadministered with TUMS® or MINTOX®.|12 hours postdose|All participants were included for whom at least one pharmacokinetic (PK) parameter could be calculated for all treatment periods and who did not have any protocol deviation interfering with pharmacokinetics|||nM||95% Confidence Interval|Least Squares Mean
2655778|NCT01622660|Primary|Progression Free Survival (PFS)|Progression Free Survival will be calculated from the start of treatment until progressive disease or death. Patients who die before documented progression will be considered failures at their time of death. If the patient did not progress or die, the patient will be censored on the date of last follow-up. Response and progression will be evaluated in this study using the international criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Measurable lesions: lesions that can be accurately measured in at least one dimension with longest diameter ≥ 10 mm by clinical exam or with spiral CT scan or MRI (no less than double the slice thickness and a minimum of 10mm). Malignant lymph nodes must be 15 mm in the short axis when assessed by spiral CT scan to be considered measurable. Non-measurable lesions: all other lesions (or sites of disease) including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm u|2 years||||days|||Number
2655779|NCT01622569|Secondary|Nasal Polyp Surgery Eligilbilty|"A subject was considered eligible for surgical intervention if the following conditions were met:~Subject has had moderate symptoms of congestion from nasal polyposis for ≥ 3 months.~Subject continues to suffer from at least moderate symptoms despite use of topical steroids at conventional doses for ≥ 6 weeks.~Subject continues to suffer from at least moderate symptoms despite use (or previous use) of saline lavage for ≥ 6 weeks.~Subject has endoscopically visualized bilateral nasal polyposis of at least moderate severity (nasal polyp grading score ≥ 2 in at least 1 nostril)."|Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label extension phase|Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase.|||Participants|||Count of Participants
2655780|NCT01622569|Secondary|Polyp Grade of 0 in at Least One Nostril|"Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. This outcome measured how many patients with a polyp grad of 0 in at least 1 nostril.~0: No polyps~Mild polyposis: polyps not reaching below the inferior border of the middle turbinate~Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate~Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate"|Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase|Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase.|||Participants|||Count of Participants
2655781|NCT01622569|Secondary|Peak Nasal Inspiratory Flow (PNIF)|The PNIF is an assessment of nasal passage obstruction and was measured using an In-Check portable nasal inspiratory flow meter. To measure PNIF, a mask was placed over the nose during inspiration and inspiratory flow was recorded. Each subject inhaled 3 times and each measurement was recorded. The PNIF value used was the greatest of the 3 results at each time point.|Baseline, Week 16 of the double-blind treatment phase, Week 24 of the open-label treatment phase|Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase.|||L/min||Standard Deviation|Least Squares Mean
2655782|NCT01622569|Secondary|Patient Global Impression of Change (PGIC) Score|"Subject responses to the question: Since starting the study drug, how would you rate the change in your symptoms? Percentage includes patients who scored either very much improved, much improved, or minimally improved."|Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase||||Participants|||Count of Participants
2655869|NCT01621737|Secondary|Calgary Depression Scale for Schizophrenia (CDSS)|The CDSS is a ten item diagnostic questionnaire intended to assess the severity of depression symptoms experienced by a given patient.|6 weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2655783|NCT01622569|Secondary|SF-36v2 - Physical Component|The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire that measures 8 domains of health: limitations in physical activities, limitations in social activities, limitations in usual role activities, bodily pain, general mental health, limitations in usual role activities, vitality, and general health perceptions. It yields scale scores for each of the 8 health domains, and 2 summary measures of physical and mental health. Each scale range is from 0-100. A lower score means more disability and a higher score means less disability.|Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase|Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase.|||units on a scale||Standard Deviation|Least Squares Mean
2655784|NCT01622569|Secondary|SF-36v2 - Mental Component|The SF-36v2 is a multipurpose, scaled, 36-item, subject-completed validated questionnaire that measures 8 domains of health: limitations in physical activities, limitations in social activities, limitations in usual role activities, bodily pain, general mental health, limitations in usual role activities, vitality, and general health. It yields scale scores for each of the 8 health domains, and 2 summary measures of physical and mental health. Each scale range is from 0-100. A lower score means more disability and a higher score means less disability.|Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase|Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase.|||units on a scale||Standard Deviation|Least Squares Mean
2655785|NCT01622569|Secondary|Rhinosinusitis Disability Index (RSDI) Total Score|The RSDI is a subject-completed instrument that evaluates the self-perceived impact of disease specific head and neck disorders. The RSDI has 30 items in 3 domains: Physical (11 items), Functional (9 items), and Emotional (10 items). The RSDI scale ranges from 0-120, 0 being better quality of life and less impact of CRS on daily function and 120 being worse quality of life and more impact of CRS on daily function.|Baseline, Week 16 of the double-blind treatment phase||||units on a scale||Standard Deviation|Least Squares Mean
2655786|NCT01622569|Secondary|MOS Sleep-R Score|The MOS Sleep-R is a brief, self-administered, validated questionnaire designed to measure key aspects of sleep, such as disturbance, adequacy, somnolence, and quantity. The 12-item version with a 4-week recall was used in this study. The score range for the 12-item version is 0 to 100, lower scores indicating better sleep and higher scores indicating worse sleep. The scale yields a Sleep Problem Index and scores on the following 6 subscales: Sleep Disturbance, Snoring, Shortness of Breath or Headache, Sleep Adequacy, Sleep Somnolence, and Sleep Quantity.|Baseline, Week 16 of the double-blind treatment phase||||units on a scale||Standard Deviation|Least Squares Mean
2655787|NCT01622569|Secondary|Sinonasal Outcome Test 22 (SNOT-22) Total Score|"SNOT-22 is a subject-completed questionnaire that consists of 22 questions. The questions on the SNOT-22 efficacy evaluation were used to calculate a total score. 22 questions are divided among 4 subscales: Rhinologic (7 questions), Ear/Facial Symptoms (4 questions), Sleep Function (3 questions), and Psychological Issues (6 questions). Each item was rated on the 5-point scale. The total score can range from 0-110, 0 being the best and 110 being the worst.~0: No problem~Very mild problem~Mild or slight problem~Moderate problem~Severe problem~Problem as bad as it can be"|Baseline, Week 16 of the double-blind treatment phase, Week 24 of the end of open-label treatment phase|Number of patients analyzed at Week 24 is lower as some patients elected not to participate in the open-label extension phase or withdrew during the open-label extension phase.|||units on a scale||Standard Deviation|Least Squares Mean
2655788|NCT01622569|Secondary|Hyposmia Score (7-day Instantaneous Morning)|"Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.~0: None~Mild, symptoms clearly present, but minimal awareness, and easily tolerated~Moderate, definite awareness of symptoms that is bothersome but tolerable~Severe, symptoms that are hard to tolerate, cause interference with activities or daily living~The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase"|Baseline, Week 16 of the double-blind treatment phase||||units on a scale||Standard Deviation|Least Squares Mean
2655789|NCT01622569|Secondary|Facial Pain or Pressure Score (7-day Instantaneous Morning)|"Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.~0: None~Mild, symptoms clearly present, but minimal awareness, and easily tolerated~Moderate, definite awareness of symptoms that is bothersome but tolerable~Severe, symptoms that are hard to tolerate, cause interference with activities or daily living~The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase"|Baseline, Week 16 of the double-blind treatment phase||||units on a scale||Standard Deviation|Least Squares Mean
2655790|NCT01622569|Secondary|Change in Rhinorrhea Score (7-day Instantaneous Morning)|"Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.~0: None~Mild, symptoms clearly present, but minimal awareness, and easily tolerated~Moderate, definite awareness of symptoms that is bothersome but tolerable~Severe, symptoms that are hard to tolerate, cause interference with activities or daily living~The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase"|Baseline, Week 16 of the double-blind treatment phase||||units on a scale||Standard Deviation|Least Squares Mean
2655791|NCT01622569|Secondary|Congestion/Obstruction Scores (7-day Instantaneous Morning)|"Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.~0: None~Mild, symptoms clearly present, but minimal awareness, and easily tolerated~Moderate, definite awareness of symptoms that is bothersome but tolerable~Severe, symptoms that are hard to tolerate, cause interference with activities or daily living~The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 16 Visit of the double-blind treatment phase"|Baseline, Week 16 of the double-blind treatment phase||||units on a scale||Standard Deviation|Least Squares Mean
2655831|NCT01621880|Primary|Number of Participants With a Treatment Response|The primary outcome of the trial was the treatment response rate at two months. The definitions of response and progressive disease were based on both the radiographic changes and clinical symptoms. We defined response as both (1)a reduction in edema volume on FLAIR images by ≥25% and (2)no deteriorating symptoms. Progressive disease was defined as either (1)larger than 10% increase in the volume of the lesions; (2)appearance of any new lesion/site; or (3)clear clinical worsening.|At 2 months.||||Participants|||Count of Participants
2655792|NCT01622569|Primary|Change in Total Polyp Grade|"Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. A summary of the changes from baseline to Week 16 in total polyp grade.~0: No polyps~Mild polyposis: polyps not reaching below the inferior border of the middle turbinate~Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate~Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate~Reduction in total polyp grade (sum of scores from both nasal cavities) at Week 16 of double-blind treatment phase; Included patients with nasal polyps at baseline"|Baseline, Week 16 of the double-blind treatment phase||||units on a scale||Standard Deviation|Least Squares Mean
2655793|NCT01622569|Primary|Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms|"Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing.~0: None~Mild, symptoms clearly present, but minimal awareness, and easily tolerated~Moderate, definite awareness of symptoms that is bothersome but tolerable~Severe, symptoms that are hard to tolerate, cause interference with activities or daily living~The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 4 Visit of the double-blind treatment phase"|Baseline, Week 4 of the double-blind treatment phase|Missing data were imputed using the multiple imputation method in the primary analyses for the co-primary efficacy variables. For other efficacy analyses, missing or invalid values were not imputed.|||units on a scale||Standard Deviation|Least Squares Mean
2655794|NCT01622543|Secondary|Overall Survival|Time from randomization to death from any cause or censored at the time of last known alive|From date of randomization to death from any cause or censored at the time of last known alive, assessed up to 49 months|All randomized patients|||Months||95% Confidence Interval|Median
2655795|NCT01622543|Secondary|Objective Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate =Proportion of (CR + PR) observed over all randomized patients.|19 months|All patients randomized to this study|||Participants|||Count of Participants
2655796|NCT01622543|Secondary|Changes in CEA Levels|Changes in CEA level from baseline to week 28 during treatment.|Baseline and at 28 weeks|All patients who had CEA levels measures at baseline and week 28.|||ng/mL||Standard Deviation|Mean
2655797|NCT01622543|Primary|Progression Free Survival|Time from the day of randomization until the first observation of objective disease relapse or progression, or the appearance of new lesions or death due to any cause. If a patient had not relapsed/progressed or died, PFS was censored on the date of last disease assessment defined as the earliest test date of target lesion or non-target lesions (if patient had no target lesions). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|19 months|All patients randomized|||Months||95% Confidence Interval|Median
2655798|NCT01622348|Primary|Mean Epidermal Thickness at End-of-Treatment (EOT) Compared to Pre-treatment|The change from pre-treatment baseline to End-of-Treatment (EOT) in the epidermal thickness of the index lesion|8 weeks|ITT population|||Millimeters||Standard Deviation|Mean
2655799|NCT01622296|Primary|Participant Pain Experience After Administration of Local Anesthesia to Numb the Gums and Teeth During Dental Treatment|"Two treatment visits were required for bilateral, mandibular dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The administering operator stepped out of the room after each injection was completed, and the participant was asked by a trained research assistant to record a visual analog scale (VAS) pain score. The VAS was used to assess pain sensitivity, and utilizes a 100mm horizontal line, with scores ranging from 0 (no pain) to 100 (pain as bad as it can be)."|immediately after anesthetic injection|per protocol, in a crossover fashion, each participant received buffered lidocaine at one treatment visit and lidocaine at one treatment visit, in randomly assigned sequence.|||units on a scale||Standard Deviation|Mean
2655800|NCT01622257|Secondary|Change in Lipid Profile|Change in LDL levels was taken as the indicator of change in lipid profile|Baseline and 3 months||||mg/dl||95% Confidence Interval|Mean
2655801|NCT01622257|Secondary|Change in Serum Free Testosterone Level|Change in serum free testosterone levels|Baseline and 3 months||||pg/ml||95% Confidence Interval|Mean
2655802|NCT01622257|Secondary|Change in Insulin Resistance|Change in Fasting insulin concentration|Baseline and 3 months||||uIU/ml||95% Confidence Interval|Mean
2655803|NCT01622257|Secondary|Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay.|"The Number of participants who had evidence of successful ovulation during the 3 months. Ovulation was diagnosed based on ultrasonographic folliculometry and/or luteal serum progesterone assay.Every month, folliculometry was done to count the number of antral follicles (AFC), follow follicular growth, measure dominant follicle diameter and detect occurrence of ovulation. a mid-luteal serum progesterone assay was done to confirm ovulation.~Ultrasound was performed serially till reaching preovulatory follicle(s of around 20 mm in diameter that then rupture to show a collapsed follicle in the same location with internal echoes consistent with its transformation to a corpus luteum. Progesterone assay was done using immulite 2000 apparatus chemiluminescent immunometric assay. Mid-luteal phase progesterone above 6 ng/mL was considered indicative of normal corpus. luteum function."|3 months||||participants|||Number
2655804|NCT01622257|Primary|Clinical Pregnancy Rate||9 months||||participants|||Number
2655805|NCT01622231|Secondary|Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=6 to <15 Years|PK samples were collected to analyze the plasma concentration of GW685698X.|Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5)|PK Concentration Population. Only those participants aged >=6 to <15 years were assessed.|||participants|||Number
2655806|NCT01622231|Secondary|Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=2 to <6 Years|Pharmacokinetic (PK) samples were collected to analyze the plasma concentration of GW685698X.|Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5)|PK Concentration Population: all participants from whom a PK sample was obtained and analyzed. Only those participants aged >=2 to <6 years were assessed.|||participants|||Number
2655807|NCT01622231|Secondary|Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant|The participant's parent/guardian who signed the ICF or the participant himself/herself evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.|Week 12/early withdrawal|FAS Population|||participants|||Number
2655808|NCT01622231|Secondary|Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator|The investigator evaluated the participant's overall response to therapy (defined as improvement in the symptoms of allergic rhinitis) compared with Visit 2 (start of the treatment period), using the following 7-point categorical scale: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, and 7=significantly worse.|Week 12/early withdrawal|FAS Population|||participants|||Number
2655809|NCT01622231|Secondary|Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge)|Rhinoscopy was assessed by the investigator by scoring swelling of inferior turbinate mucosa (SOITM) scored as 0 (none), 1 (possible to see center of the middle turbinate), 2 (between 3 and 1), or 3 (impossible to see middle turbinate); color of inferior turbinate mucosa (COITM) scored as 0 (normal), 1 (pink), 2 (red), or 3 (pale); quantity of nasal discharge (QTND) scored as 0 (none), 1 (small amount adhered), 2 (between 3 and 1), or 3 (filled); and quality of nasal discharge (QLND) scored as 0 (none), 1 (pyoid), 2 (viscous), or 3 (watery).|Baseline, Week 4, Week 8, and Week 12/early withdrawal|FAS Population. Only those participants available at the indicated time points were assessed.|||participants|||Number
2655810|NCT01622231|Secondary|Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The participant's parent/guardian who signed the ICF or the participant themself scored the participant's troubles with daily life once daily using the following scale: 0, None; 1, Few troubles; 2, Intermediate between 3 and 1; or 3, Painful and complicating daily life. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.|||Scores on a scale||Standard Deviation|Mean
2655811|NCT01622231|Secondary|Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|Three individual symptoms (eye itching, tearing, and redness) were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.|||Scores on a scale||Standard Deviation|Mean
2655812|NCT01622231|Secondary|Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|Four individual symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching) were scored on a scale from 0 to 3 using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the symptom scores in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.|||Scores on a scale||Standard Deviation|Mean
2655813|NCT01622231|Secondary|Mean Percent Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.|||Percent change||Standard Deviation|Mean
2655870|NCT01621737|Secondary|Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)|The MSCEIT™ ME is a multiple choice test that asses how individuals manage their emotions.|6 weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2655814|NCT01622231|Secondary|Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|Symptoms of eye itching, tearing, and redness were scored by the participant's parent/guardian who signed the ICF or the participant themself using a scale of 0, 1, 2, or 3 (a larger score indicates more severe symptoms) and were recorded in the participant's diary. The TOSS is the sum of all three symtpom scores and ranges from 0 to 9. The mean of the Baseline period is defined as the mean score of 4 consecutive days prior to Visit 2 (start of the treatment period). The mean of each assessment period is defined as the mean score of the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12. For each assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.|||Scores on a scale||Standard Deviation|Mean
2655815|NCT01622231|Secondary|Mean Percent Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.|||Percent change||Standard Deviation|Mean
2655816|NCT01622231|Secondary|Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The 4TNSS is the sum of the 4 individual symptom scores for sneezing, rhinorrhea, nasal congestion, and nasal itching. Each symptom is scored on a scale from 0 to 3; the range of sums for the 4TNSS is 0 to 12. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the ICF or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average of the 4TNSS in the last 4 consecutive days prior to Visit 2 (start of the treatment period). A mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.|||Scores on a scale||Standard Deviation|Mean
2655817|NCT01622231|Secondary|Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS)|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The BL value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from BL was calculated as the mean score for the entire treatment period minus the score at BL. Only those participants available at the indicated time points were assessed.|Baseline, Day 1 to Day 84|Full Analysis Set (FAS) Population: all participants meeting the primary criteria for enrollment, without any major good clinical practice (GCP) deviation, who received at least one dose of the assigned treatment and had diary assessment for 3TNSS after receiving a dose of study medication.|||Scores on a scale||Standard Deviation|Mean
2655818|NCT01622231|Secondary|Mean Percent Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Percent change from Baseline=(mean score at the post-Baseline assessment minus the score at Baseline) divided by the Baseline value * 100.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.|||Percent change||Standard Deviation|Mean
2655832|NCT01621802|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.|During the entire study period (from Day 0 up to Day 180)|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2657238|NCT01607450|Primary|Myocardial Glucose Uptake.|Myocardial glucose uptake measured using 18FDG PET, quantified using a 3-compartment model with a lumped constant of 1.0.|After 12 hours of glucagon-like peptide 1 (GLP-1) exposure||||umol/min/100g||Standard Deviation|Mean
2655819|NCT01622231|Secondary|Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|The 3TNSS is the sum of the 3 individual symptom scores for sneezing, rhinorrhea, and nasal congestion. Each symptom is scored on a scale from 0 to 3; the range of sums for the 3TNSS is 0 to 9. The symptoms were evaluated using a scale of 0, 1, 2, or 3; a larger score indicates more severe symptoms. The participant's parent/guardian who signed the informed consent form (ICF) or the participant themself scored nasal symptoms every day during the screening period and the treatment period. The Baseline value is defined as the average 3TNSS over the last 4 consecutive days prior to Visit 2 (start of the treatment period). For the entire assessment period, a mean score for each participant was calculated using available diary data from the assessment periods, taking the average of non-missing data during the period. Change from Baseline was calculated as the mean score for the entire treatment period minus the score at Baseline.|Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12|FAS Population. Only those participants available at the indicated time points were assessed.|||Scores on a scale||Standard Deviation|Mean
2655820|NCT01622231|Secondary|Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.|||Millimoles (mmol)/L||Standard Deviation|Mean
2655821|NCT01622231|Secondary|Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.|||Micromoles (μmol)/L||Standard Deviation|Mean
2655822|NCT01622231|Secondary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.|||International units (IU)/L||Standard Deviation|Mean
2655823|NCT01622231|Secondary|Change From Baseline in Albumin and Total Protein at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.|||grams/L||Standard Deviation|Mean
2655824|NCT01622231|Secondary|Change From Baseline in Hematocrit at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.|||Proportion of RBCs in blood||Standard Deviation|Mean
2655825|NCT01622231|Secondary|Change From Baseline in Red Blood Cell (RBC) Count at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.|||tera (10^12) cells (TI)/L||Standard Deviation|Mean
2655826|NCT01622231|Secondary|Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.|||giga (10^9) cells (GI)/L||Standard Deviation|Mean
2655827|NCT01622231|Secondary|Change From Baseline in Hemoglobin at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.|||Grams per liter (grams/L)||Standard Deviation|Mean
2655828|NCT01622231|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal|Change from Baseline was calculated as the value at the post-Baseline time points minus the value at Baseline. Basophils, eosinophils, lymphocytes, monocytes, and total neutrophil counts are measured as the percentage of cells in white blood cells.|Baseline, Week 4, and Week 12/Early Withdrawal|Safety Population. Only those participants available at the indicated time points were assessed.|||Percentage of cells||Standard Deviation|Mean
2655829|NCT01622231|Primary|Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an other important medical event, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=5%) and SAEs.|From the start of study treatment (Visit 2) until follow-up contact (Visit 6) (up to 13 weeks)|Safety Population: all participants who received at least one dose of medication|||participants|||Number
2655830|NCT01621880|Secondary|Percentage Change in Radiological Measures of Lesion Volume|T1 post-gadolinium imaging was used to measure the enhancement and T2-weighted FLAIR to measure the edema. For lesion measurements, radiologists used manual and semiautomatic approaches to identify the outline of the lesion, and the total volume was estimated with Volume Viewer 2 software(GE Healthcare, AW Suite2.0 6.5.1.z).|Change from baseline to evaluation at 2 months.||||percentage||Standard Deviation|Mean
2655868|NCT01621737|Secondary|Hamilton-Anxiety Scale (HAM-A)|The HAM-A is a clinician administered scale for the evaluation of anxiety symptoms. It consists of 14 items of which each item is scored 0 (not present) to 4 (very severe).|6 weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2655833|NCT01621802|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 43-day (Days 0-42) post-vaccination period|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2655834|NCT01621802|Secondary|Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits|The number of subjects reporting adverse events resulting in Emergency Room (ER) visits is reported.|During the entire study period (from Day 0 up to Day 180)|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2655835|NCT01621802|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCDs)|NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.|During the entire study period (from Day 0 up to Day 180)|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2655836|NCT01621802|Secondary|Number of Subjects Reporting Investigator-confirmed Rash|Assessed any rash, varicella-like rash, measles/rubella-like rash, Grade 3, related. Any= occurrence of rash regardless of intensity grade. Grade 3 measles/rubella/varicella-like rash = Rash with more than 150 lesions. Other Grade 3 Rash = Rash that prevented normal, everyday activities. Related= Rash assessed by the investigator as causally related to study vaccination.|During the 43-day (Days 0-42) post-vaccination period|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).|||Participants|||Count of Participants
2655837|NCT01621802|Secondary|Number of Subjects Reporting MMR Specific Solicited General Symptoms|Assessed MMR specific symptoms were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Grade 3 Sign of meningism (any suspected signs including febrile convulsions) = An event which prevented normal, everyday activities. Related = symptom assessed by the investigator as causally related to study vaccination.|During the 43-day (Days 0-42) post-vaccination period|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).|||Participants|||Count of Participants
2655838|NCT01621802|Secondary|Number of Subjects Reporting Fever|Any fever = fever ≥ 38°C; Grade 3 fever = fever > 39.5°C; Related = fever assessed by the investigator as causally related to study vaccination.|During the 43-day (Days 0-42) post-vaccination period|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).|||Participants|||Count of Participants
2655839|NCT01621802|Secondary|Number of Subjects With Solicited General Symptoms|"Assessed solicited general symptoms were drowsiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness = Drowsiness that prevented normal activity, Grade 3 Loss of appetite = Not eating at all. Related = symptom assessed by the investigator as causally related to study vaccination.~Analysis was done for sub-cohort 1 only."|During the 4-day (Days 0-3) post-vaccination period|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).|||Participants|||Count of Participants
2655840|NCT01621802|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (m m ) i.e . > 50mm.|During the 4-day (Days 0-3) post-vaccination period|This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).|||Participants|||Count of Participants
2655841|NCT01621802|Secondary|Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers|Antibody titers were expressed as Geometric Mean Titers (GMTs) in ED50. Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||ED50||95% Confidence Interval|Geometric Mean
2655842|NCT01621802|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL|Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
2655843|NCT01621802|Secondary|Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL|Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
2655844|NCT01621802|Secondary|Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||EU/mL||95% Confidence Interval|Geometric Mean
2655845|NCT01621802|Secondary|Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||IU/mL||95% Confidence Interval|Geometric Mean
2655846|NCT01621802|Secondary|Number of Subjects With Antibody Booster Response to Pertactin (PRN)|"Booster response was defined as:~For initially seronegative subjects, antibody concentration ≥ 8.748 IU/mL at Day 42.~For initially seropositive subjects with pre-vaccination antibody concentration < 8.748 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.~For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.748 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.~Analysis was done in sub-cohort 1 only."|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
2655847|NCT01621802|Secondary|Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)|"Booster response was defined as:~For initially seronegative subjects, antibody concentration ≥ 8.184 IU/ml at Day 42.~For initially seropositive subjects with pre-vaccination antibody concentration < 8.184 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.~For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.184 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.~Analysis was done in sub-cohort 1 only."|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
2655848|NCT01621802|Secondary|Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT)|"Booster response was defined as:~For initially seronegative subjects, antibody concentration ≥ 10.772 IU/mL at Day 42.~For initially seropositive subjects with pre-vaccination antibody concentration < 10.772 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.~For initially seropositive subjects with pre-vaccination antibody concentration ≥ 10.772 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.~Analysis was done in sub-cohort 1 only."|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
2655849|NCT01621802|Secondary|Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T)|"Booster response was defined as:~For subjects with pre-vaccination antibody concentration less than (<) 0.1 IU/mL, antibody concentration ≥ 0.4 IU/ml at Day 42.~For subjects with pre-vaccination antibody concentration ≥ 0.1 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.~Analysis was done in sub-cohort 1 only."|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
2655850|NCT01621802|Secondary|Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations|Antibody concentrations were expressed as GMCs in mIU/mL. Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||mIU/mL||95% Confidence Interval|Geometric Mean
2655851|NCT01621802|Secondary|Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥ 75 mIU/mL. Analysis was done in sub-cohort 1 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
2655852|NCT01621802|Primary|Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations|Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohorts 1 and 2 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for rubella vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||IU/mL||95% Confidence Interval|Geometric Mean
2655853|NCT01621802|Primary|Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations|Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohorts 1 and 2 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for mumps vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||EU/mL||95% Confidence Interval|Geometric Mean
2655854|NCT01621802|Primary|Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analysis was done in sub-cohorts 1 and 2 only.|42 days after vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for measles vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||mIU/mL||95% Confidence Interval|Geometric Mean
2655855|NCT01621802|Primary|Number of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Units per milliliter (IU/mL). Analysis was done in sub-cohorts 1 and 2 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for rubella vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
2655856|NCT01621802|Primary|Number of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Units per milliliter (EU/mL). Analysis was done in sub-cohorts 1 and 2 only.|42 days post vaccination (At Day 42)|This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for mumps vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
2655857|NCT01621802|Primary|Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value|Seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal to or above (≥) 200 milli-international Units per milliliter (mIU/mL). Analysis was done in sub-cohorts 1 and 2 only.|42 days post vaccination (At Day 42)|This analysis was performed on According to Protocol (ATP) cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for measles vaccine component, did not meet any elimination criteria up to Visit 2 blood sample & complied with protocol procedures.|||Participants|||Count of Participants
2655858|NCT01621776|Secondary|Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast|Blood glucose concentrations were measured prior to and 120 minutes following breakfast. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model.|averaged over 5 days||||mg/dl||Standard Deviation|Mean
2655859|NCT01621776|Secondary|Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner|Blood glucose concentrations were measured prior to and 120 minutes following dinner. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model.|averaged over 5 days||||mg/dl||Standard Deviation|Mean
2655860|NCT01621776|Primary|The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch.|"Blood glucose concentrations were measured prior to and 90 minutes following lunch. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model.~The number of participants for analysis was based upon a convenience sample of individuals attending Florida Camp for Children and Youth with Diabetes at Camp Winona."|averaged over 5 days|Post-Prandial Blood Glucose Values [Within 90 minutes following the completion of participant lunch]|||mg/dl||Standard Deviation|Mean
2655861|NCT01621737|Secondary|Penn Emotion Recognition Test (ER-40)|The ER-40 is a computerized emotion discrimination test presenting 40 color photographs of evoked happy, sad, anger, fear and neutral expressions balanced for poser gender and ethnicity.|6 weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2655862|NCT01621737|Secondary|Social Phobia Inventory (SPIN)|The SPIN is a patient self-report scale that measures the degree of social phobia in a variety of different social situations.|6 weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2655863|NCT01621737|Secondary|Arizona Sexual Experience Scale (ASEX)|"The ASEX is a self-rated scale to assess sexual functioning. The ASEX consists of 5 items that the subject will rate from 1 (extremely strong, easily, or satisfying) to 6 (absent or never) based on how he/she feels at the time."|6 weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2655864|NCT01621737|Secondary|Experience Close Relationships (ECR)|The ECR is a self-rated questionnaire designed to assess individual differences with respect to attachment-related anxiety (i.e., the extent to which people are insecure vs. secure about the extent to which their partner's availability and responsiveness) and attachment-related avoidance (i.e., the extent to which people are uncomfortable being close to others vs. secure depending on others) .|6 weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2655865|NCT01621737|Secondary|Childhood Trauma Questionnaire (CTQ)|The CTQ is a validated measure of adverse early experiences characterized on a measure of Anxiety Sensitivity Index and retrospective childhood maltreatment. A 5-point frequency of occurrence scale is utilized: (1) never true, (2) rarely true, (3) sometimes true, (4) often true, and (5) very often true. Each sub-scale score ranges from 5 (no history of abuse or neglect) to 25 (very extreme history of abuse and neglect).|6 weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2655866|NCT01621737|Secondary|Treatment Satisfaction Questionnaire for Medication (TSQM)|The TSMQ is a brief questionnaire asking patients about how satisfied they were with the ease, timing, etc. of the study medication giving a good indication of adherence|6 weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2655867|NCT01621737|Secondary|Paranoid Thoughts Scale (PTS)|The PTS is a self-rated scale to assess current paranoia symptoms. The PTS consists of 32 items that the subject rates from 1 (not at all) to 5 (totally).|6 weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2655871|NCT01621737|Secondary|Computerized Multiphasic Interactive Neurocognitive DualDisplayTM System (CMINDS®)|"The CMINDS ® consists of construct-equivalent computerized versions of the neurocognitive assessment instruments constituting the MATRICS™ Consensus Cognitive Battery (MCCB™)."|6 weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2655872|NCT01621737|Secondary|Clinical Global Impression-Global Improvement (CGI-I)|The CGI-I is a global assessment to evaluate the subject's improvement or worsening from baseline. Scores on the CGI-I scale range from 1 (very much improved) to 7 (very much worse).|6 weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2655873|NCT01621737|Secondary|Clinical Global Impression-Severity of Illness (CGI-S)|The CGI-S is used to evaluate changes in overall severity of illness. Scores range from 1 (not at all) to 7 (among the most extremely ill).|6 weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2655874|NCT01621737|Secondary|Global Assessment of Functioning (GAF)|The GAF considers psychological, social, and occupational functioning on a hypothetical continuum of mental health illness. Scores on the GAF range from 1 (extremely severe) to 100 (superior functioning).|6 weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2655875|NCT01621737|Primary|Change in Total Score in the Positive and Negative Syndrome Scale (PANSS)From Baseline to Endpoint|The three subscales of the PANSS include the Positive scale (7 items), the Negative scale (7 items), and the General Psychopathology scale (16 items). The total PANSS score is the sum of all 30 items of which each item is scored on a 1-7 rating system (7 indicating the worst symptoms). The items on the PANSS focus on symptoms that are common in patients with psychotic disorders and include hallucinations, delusions and disorganization as well as mood disturbances.|6 weeks|The PI has left the institution and this study was terminated due to loss of funding. The data was not analyzed.||||||
2655876|NCT01621672|Primary|Progression Free Survival (PFS)|"Progression was defined as any one or more of the following:~Serum M protein increase ≥ 25% from baseline (or an increase of ≥ 1 g/dL if serum M protein was ≥ 5 g/dL at baseline), with an absolute increase of ≥ 0.5 g/dL; or~Urine M protein increase ≥ 25% from baseline, with an absolute increase of ≥ 200 mg/24 hrs; or~If patient had serum M protein < 1 g/dL, urine M protein < 200 mg/24 hrs, and an involved serum free light chain level ≥ 10 mg/dL at baseline: ≥ 25% increase in the difference between involved and uninvolved serum free light chain level, with an absolute increase of ≥ 10 mg/dL; or~Bone marrow plasma cell percentage increase ≥ 25% from baseline, with the absolute plasma cell % ≥ 10%; or~New bone lesions or soft tissue plasmacytomas, or definite increase in size of existing bone lesions or soft tissue plasmacytomas; or~Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to multiple myeloma."|2 years||||percentage of participants|||Number
2655877|NCT01621633|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Adverse events, serious adverse events and death were monitored from screening to end of study|From the screening visit until Day 5|Safety set: The safety set includes all participants who received study treatment.|||Participants|||Number
2655878|NCT01621633|Primary|Maximum Plasma Concentration (Cmax) for LCZ696 Analytes (AHU377, LBQ657, and Valsartan)|Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing|From pre-dose on Day 1 until 96h post-dose (Day 5)|PK analysis set|||ng/mL||Standard Deviation|Mean
2655879|NCT01621633|Primary|Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUCinf)] of LCZ696 Analytes (AHU377, LBQ657, and Valsartan)|Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing|From pre-dose on Day 1 until 96h post-dose (Day 5)|PK analysis set|||ng*hr/mL||Standard Deviation|Mean
2655880|NCT01621633|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LCZ696 Analytes (AHU377, LBQ657, and Valsartan)|Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing|From pre-dose on Day 1 until 96h post-dose (Day 5)|PK analysis set: The PK analysis set included all subjects with at least one available, valid (i.e. not flagged for exclusion) PK concentration measurement, who received any study drug, and experienced no protocol deviations with relevant impact on PK data.|||ng*hr/mL||Standard Deviation|Mean
2655881|NCT01621542|Secondary|Immune Response to WT2725|The modified IWG response criteria were used to assess drug activity in AML patients. Tumor assessments will be conducted during screening, and then every 8 weeks after the first dose of study drug. All tumor assessments may be performed within ±7 days of the scheduled assessment. All patients should complete an End of Study visit within 28 days after the last dose of study drug and prior to the start of alternate antineoplastic therapy.|Day 1 - within 28 days after last dose|Efficacy population for modified IWG response: includes all the AML patients in the Safety population who have >5% marrow blasts or >50 copy/μｇRNA of quantitative RT-PCR for WT1 transcript before the first date/time of study drug and who have at least one posttreatment assessment.|||participants|||Number
2655882|NCT01621542|Secondary|Antitumor Responses to WT2725 Based on the Immune-related Response Criteria (irRC)|Tumor response, as evaluated according to irRC, was based on total measurable tumor burden in patients with solid tumors (ie, non-AML patients). Tumor assessments will be conducted during screening, and then every 8 weeks after the first dose of study drug. All tumor assessments may be performed within ±7 days of the scheduled assessment. All patients should complete an End of Study visit within 28 days after the last dose of study drug and prior to the start of alternate antineoplastic therapy.|Day 1 - within 28 days after last dose|Efficacy irRC population: including all the patients in the Safety population who are not AML patients and whose lesions are measureable and have at least one posttreatment assessment.|||participants|||Number
2655883|NCT01621542|Primary|Maximum Tolerated Dose (MTD) of WT2725 Based on the Evaluation of Dose-limiting Toxicity (DLT)||Day 1 - Day 29|Safety Population (defined as all enrolled patients who received at least one dose of study drug.)|||Dose Limiting Toxicity|||Number
2657976|NCT01601977|Primary|Control of Nocturnal Hypoventilation|transcutaneous CO2 recording from overnight sleep study whilst using the device at 6 weeks compared to baseline control when using usual device|baseline, 6 week assessment||||kPa||Standard Deviation|Mean
2655884|NCT01621542|Primary|Occurrence of Dose-limiting Toxicities and Adverse Events|Evaluation of the safety and tolerability of WT2725 Dosing Emulsion based on the occurrence of DLT and AEs The safety and tolerability of WT2725 Dosing Emulsion will be evaluated based on the occurrence of DLT and AEs, and the findings from clinical laboratory tests, vital signs measurements, body weight measurements, and electrocardiogram (ECG) results. The incidence of DLT will be evaluated during the DLT Evaluation Period, which extends from the day of the first dose to just prior to the fifth dose of study drug (Days 1 to 29). No more than 4 doses of study drug will be administered during the DLT Evaluation Period.|Up to 4 months|Safety Population (defined as all enrolled patients who received at least one dose of study drug.)|||number of occurances|||Number
2655885|NCT01621490|Secondary|Antitumor Activity of Nivolumab and Nivolumab in Combination With Ipilimumab as Measured by the Overall Survival Rate (OSR)|The proportion of subjects surviving to time t, where t is a specific length of time, eg, 12 months, which was determined by the available data for final analysis and was documented in the DPP. The proportion was calculated by the product-limit method (Kaplan-Meier estimate), which takes into account censored data. The overall survival rate (OSR) for a subject was defined as the time from the date of first dose of study medication to the date of death for any cause. A subject who had not died was censored at last known date alive|2 years from first dose of treatment; Assessed up to September 2017|All treated participants|||Percentage of participants||95% Confidence Interval|Median
2655886|NCT01621490|Secondary|Association Between Programmed Cell Death Ligand 1 (PD-L1) and Clinical Efficacy Measures Such as Overall Survival Rate (PD-L1 OSR)|For immunohistochemistry (IHC) measurements, to explore the PD-L1 expression as a potential predictive marker of clinical activity, PD-L1 expression status were derived from percent of tumor cells exhibiting cell surface staining for PD-L1 at baseline and/or in archived biopsy samples using verified and/or validated assays. In the case of multiple specimens, a subject would be identified as PD-L1 expression levels >= x%, where x% can be 10%, 5%, and/or 1% in any of the baseline and/or archived specimens. The association between PD-L1 expression status and/or level and clinical efficacy measures was assessed. The overall survival rate (OSR) for a subject was defined as the time from the date of first dose of study medication to the date of death for any cause. A subject who had not died was censored at last known date alive|2 years from first dose of treatment; Assessed up to September 2017|Biomarker evaluable participants|||Percentage of participants||95% Confidence Interval|Number
2655887|NCT01621490|Secondary|Association Between Programmed Cell Death Ligand 1 (PD-L1) and Clinical Efficacy Measures Such as Progression Free Survival (PD-L1 PFS)|For immunohistochemistry (IHC) measurements, to explore the PD-L1 expression as a potential predictive marker of clinical activity, PD-L1 expression status were derived from percent of tumor cells exhibiting cell surface staining for PD-L1 at baseline and/or in archived biopsy samples using verified and/or validated assays. In the case of multiple specimens, a subject would be identified as PD-L1 expression levels >= x%, where x% can be 10%, 5%, and/or 1% in any of the baseline and/or archived specimens. The association between PD-L1 expression status and/or level and clinical efficacy measures was assessed. The progression free survival rate (PFSR) for a subject was defined as the time from the date of first dose of study medication to the date of the first documented disease progression, or death due to any cause, whichever occurred first, if death occurred within 100 days after last dose of study medication.|2 years from first dose of treatment; Assessed up to September 2017|All response-evaluable participants|||Months||95% Confidence Interval|Median
2655888|NCT01621490|Secondary|Association Between Programmed Cell Death Ligand 1 (PD-L1) and Clinical Efficacy Measures Such as the Duration of Response (PD-L1 DOR)|For immunohistochemistry (IHC) measurements, to explore the PD-L1 expression as a potential predictive marker of clinical activity, PD-L1 expression status were derived from percent of tumor cells exhibiting cell surface staining for PD-L1 at baseline and/or in archived biopsy samples using verified and/or validated assays. In the case of multiple specimens, a subject would be identified as PD-L1 expression levels >= x%, where x% can be 10%, 5%, and/or 1% in any of the baseline and/or archived specimens. The association between PD-L1 expression status and/or level and clinical efficacy measures was assessed. Median duration of response (mDOR) was calculated for all response-evaluable participants with best overall response of CR or PR only, and is defined as time between the date of first documented objective response and the date of the first subsequent disease progression or death, whichever occurred first, if death occurred within 100 days after last dose of study medication.|2 years from first dose of treatment; Assessed up to September 2017|All response-evaluable participants|||Months||95% Confidence Interval|Median
2655889|NCT01621490|Secondary|Association Between Programmed Cell Death Ligand 1 (PD-L1) and Clinical Efficacy Measures Such as Objective Response Rate (PD-L1 ORR)|For immunohistochemistry (IHC) measurements, to explore the PD-L1 expression as a potential predictive marker of clinical activity, PD-L1 expression status were derived from percent of tumor cells exhibiting cell surface staining for PD-L1 at baseline and/or in archived biopsy samples using verified and/or validated assays. In the case of multiple specimens, a subject would be identified as PD-L1 expression levels >= x%, where x% can be 10%, 5%, and/or 1% in any of the baseline and/or archived specimens. The association between PD-L1 expression status and/or level and clinical efficacy measures was assessed. The objective response rate (ORR) was defined as the number of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized subjects in the population of interest (all response-evaluable participants).|2 years from first dose of treatment; Assessed up to September 2017|All response-evaluable participants|||Percentage||95% Confidence Interval|Number
2655890|NCT01621490|Secondary|Immunogenicity of Nivolumab and Nivolumab in Combination With Ipilimumab as Measured by the Number of Serum Anti-drug Antibody (ADA) Positive Participants and the Number of Neutralizing ADA Positive Participants|Time Frame: Part 1: Day 1, Day 15, Day 43 of cycle 1, Day 1 of cycle 2, Day 15 of cycle 3, every 16 weeks after cycle 3 up to 2 years, follow-up visit 1 (40-60 days after last treatment), and follow-up visit 2 (101-120 days since last treatment) Part 2, 3 and 4: Weeks 1, 3, 4, 7, 9, 10, 13, 25, 53, 79, 95 follow-up visit 1 (40-60 days after last treatment), and follow-up visit 2 (101-120 days since last treatment)|Up to follow-up visit 2 (101-120 days since last treatment)|A subset of all treated subjects who had a baseline and at least 1 post-baseline ADA assessment for nivolumab and ipilimumab separately|||Participants|||Number
2656420|NCT01615822|Secondary|OZ439 Cmax|Peak Plasma Concentration (Cmax) of OZ439|Up to 42 days post-dose|Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2655891|NCT01621490|Secondary|Antitumor Activity of Nivolumab and Nivolumab in Combination With Ipilimumab as Measured by the Progression Free Survival Rate (PFSR)|The progression free survival rate (PFSR) for a subject was defined as the time from the date of first dose of study medication to the date of the first documented disease progression, or death due to any cause, whichever occurred first, if death occurred within 100 days after last dose of study medication.|2 years from the first dose of treatment|All treated subjects|||Percentage||95% Confidence Interval|Median
2655892|NCT01621490|Secondary|Antitumor Activity of Nivolumab and Nivolumab in Combination With Ipilimumab as Measured by the Median Time to Response (mTTR)|Median time to response (mTTR) for a participant with a BOR of CR or PR is defined as the time from the first dosing date to the date of the first documented objective response (CR or PR).|2 years from the first dose of treatment|All treated participants|||Months||95% Confidence Interval|Median
2655893|NCT01621490|Secondary|Antitumor Activity of Nivolumab and Nivolumab in Combination With Ipilimumab as Measured by the Median Duration of Response (mDOR)|Median duration of response (mDOR) was calculated for subjects with BOR of CR or PR only, and is defined as time between the date of first documented objective response and the date of the first subsequent disease progression or death, whichever occurred first, if death occurred within 100 days after last dose of study medication.|2 years from the first dose of treatment||||Months||95% Confidence Interval|Median
2655894|NCT01621490|Secondary|Antitumor Activity of Nivolumab and Nivolumab in Combination With Ipilimumab as Measured by the Objective Response Rate (ORR)|The objective response rate (ORR) was defined as the number of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized subjects in the population of interest (eg, all treated subjects or response-evaluable subjects). The BOR was defined as the subject's best response designation, over the study as a whole, recorded between the date of first study drug administration and the date of objectively documented progression per RECIST 1.1, with subsequent confirmation, or date of subsequent anti-cancer therapy, whichever occurred first in the study.|Approximately every 8 weeks until disease progression and in follow-up if no progression|All treated subjects|||Percentage of participants||95% Confidence Interval|Number
2655895|NCT01621490|Secondary|Number of Laboratory Abnormalities in Specific Thyroid Tests|Abnormalities in thyroid parameters measured included those in thyroid stimulating hormone (TSH) levels with respect to upper limit of normal (ULN) and lower limit of normal (LLN)|101-120 days after last dose.|Participants with at least one on-treatment measurement of TSH|||Events|||Number
2655896|NCT01621490|Secondary|Number of Laboratory Abnormalities in Specific Liver Tests|Abnormalities in hepatic parameters measured included those in aspartate aminotransferase (AST), alanine aminotransferase (ALT)and total bilirubin, with respect to upper limit of normal (ULN)|101-120 days after last dose.|Participants with at least one on-treatment measurement of the corresponding laboratory parameter|||Events|||Number
2655897|NCT01621490|Secondary|Safety and Tolerability of Nivolumab, Ipilimumab and Nivolumab in Combination With Ipilimumab as Measured by SAEs and AEs Leading to Discontinuation of Study Drug.|The assessment of safety was based on frequency of SAEs and AEs leading to discontinuation of study drug. AEs were coded using the MedDRA Version 20.1 AEs and laboratory values were graded for severity according to the NCI CTCAE version 4.0.|From enrollment to 100 days after the last dose date||||Events|||Number
2655898|NCT01621490|Secondary|Safety and Tolerability of Nivolumab, Ipilimumab and Nivolumab in Combination With Ipilimumab as Measured by the Number of Deaths and AEs|The assessment of safety was based on frequency of deaths, AEs, SAEs, AEs leading to discontinuation of study drug, and abnormalities in specific clinical laboratory assessments. AEs were coded using the MedDRA Version 20.1 AEs and laboratory values were graded for severity according to the NCI CTCAE version 4.0.|Includes events reported between first dose and up to 100 days after last dose of study medication.||||Events|||Number
2655899|NCT01621490|Primary|Tumor Infiltrating Lymphocytes (TILs) as Measured by Medians in Percent Positive CD8 and Positive CD4 at Baseline and On-treatment Biopsy, Both Using the Mosaic Singleplex IHC Assay|Biomarkers examined were percent positive CD8 and percent positive CD4, both using the Mosaic Singleplex IHC assay. Analyses are presented with the medians at baseline and on-treatment, rather than the median change because the baseline values differed across groups. Baseline was defined as the last non-missing value on or prior to the first dose of study therapy. Biopsies were also collected on treatment.|From last non-missing value prior to first dose to week 4 day 1|Response evaluable participants|||Percentage of positive cells||Standard Deviation|Median
2655900|NCT01621490|Primary|Median Change From Baseline to Week 7, of Interferon (IFN) and Interferon Gamma (IFN-gamma) Inducible Factors|Baseline and post-treatment modulation of serum levels of chemokines, cytokines and other immune mediators were assessed by techniques that included ELISA or other multiplex-based assay methods. Primary analysis included IFN-gamma and IFN-gamma inducible factors, including chemokine [C-X-C motif] ligand 9 (CXCL9) and CXCL10|From last non-missing value prior to first dose to week 7 day 1|All response evaluable participants|||pg/mL||Standard Deviation|Median
2655901|NCT01621477|Secondary|Number of Participants With Transplant Related Mortality (TRM)|The number of participants who died due to TRM in the first 100 days post-transplant is given.|100 days post transplant||||participants|||Number
2655902|NCT01621477|Secondary|Incidence and Severity of Chronic Graft Versus Host Disease (GVHD)|The severity of chronic GVHD will be described. Chronic GVHD was evaluated using NIH Consensus Global Severity Scoring. The number of participants with chronic GVHD is given, organized by severity.|100 days post transplant||||participants|||Number
2655903|NCT01621477|Secondary|Incidence and Severity of Acute Graft Versus Host Disease (GVHD)|The number of participants with acute GVHD is given, organized by grade. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe.|100 days post transplant||||participants|||Number
2655904|NCT01621477|Secondary|Disease-Free Survival (DFS)|Estimate the DFS at one-year post-transplantation. The event is defined as relapse or death due to relapse. The number of participants who did not relapse up to one year post transplant is reported.|one year post transplant||||participants|||Number
2655905|NCT01621477|Secondary|Event-Free Survival (EFS)|Estimate the EFS at one-year post-transplantation. The event is defined as relapse or death due to any cause. The number of participants who were alive without relapse at one year post-transplant is reported.|one year post transplant||||participants|||Number
2655906|NCT01621477|Secondary|Incidence of Malignant Relapse|Estimate the incidence of malignant relapse at one year post-transplant. The number of participants with malignant relapse or progressive disease is given. Relapse was evaluated using standard WHO criteria for each disease.|One year post transplantation.||||participants|||Number
2655907|NCT01621477|Primary|One-year Survival (OS)|Evaluate the number of participants alive at 1 year. The number of participants surviving to one-year post-transplantation is given.|One year post transplant||||participants|||Number
2655908|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010|WPI: Participant-reported areas (out of 19 points on the body) in which the participant had pain in the past week. WPI scores ranged from 0 (no areas) to 19 (all areas). SS: The sum of severity scores for fatigue, waking unrefreshed, and cognitive symptoms [each rated from 0 (no problem) to 3 (severe; life-disturbing problems)] plus the severity of somatic symptoms in general [rated from 0 (no symptoms) to 3 (a great deal of symptoms)]. The total SS score ranged from 0 and 12.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 WPI or SS assessment.|||units on a scale||Standard Deviation|Mean
2655909|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in Beck Depression Inventory-II (BDI-II)|The BDI-II is a 21-item self-administered questionnaire designed to assess the characteristics of depression. Each item was scored on a 4-point scale ranging from 0 (not present) to 3 (present in the extreme) and was summed to give a total BDI-II score. A total BDI-II score of 0 through 13 was considered minimal, 14 through 19 was mild, 20 through 28 was moderate, and 29 through 63 was severe depression symptoms.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 BDI-II assessment.|||units on a scale||Standard Deviation|Mean
2655910|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores|The SF-36 Health Survey is a generic, health-related survey assessing the participant's quality of life on 8 domains: physical functioning, daily functioning (physical), bodily pain, general health, vitality, social functioning, daily functioning (emotional), and mental health. Each domain was scored by summing individual items pertaining to that domain and transforming scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 SF-36 assessment.|||units on a scale||Standard Deviation|Mean
2655911|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function, respectively. Severity scores ranged from 0 (no pain) to 10 (severe pain) for each question assessing average pain, worst pain, least pain, and pain right now. Interference scores ranged from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain in past 24 hours with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference was the average of non-missing scores of individual interference items.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 BPI-S or BPI-W assessment.|||units on a scale||Standard Deviation|Mean
2655912|NCT01621191|Secondary|Change From Baseline to 50-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)|FIQ is a 20-item, self-administered questionnaire using Likert-type scales to measure participant outcomes over the past week. Items 1 through 11 measured physical functioning on 4-point scales. Items 12 and 13 measured the number of days a participant felt well and days a participant was unable to work due to fibromyalgia symptoms, respectively. Items 14 through 20 were 11-point scales on which a participant rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression, respectively. If a participant did not do all the tasks listed, those items were deleted from scoring. Algorithms were used to determine total FIQ scores which ranged from 0 to 100; higher scores indicated a more negative impact.|Baseline, 50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 FIQ assessment.|||units on a scale||Standard Deviation|Mean
2655913|NCT01621191|Secondary|Clinical Global Impression-Improvement (CGI-I) at Endpoint|CGI-I measures the clinician's perception of participant improvement at the time of assessment (compared with the start of treatment). Scores ranged from 1 (very much better) to 7 (very much worse).|50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 CGI-I assessment.|||units on a scale||Standard Deviation|Mean
2655914|NCT01621191|Secondary|Patient Global Impression-Improvement (PGI-I) at Endpoint|PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse).|50 weeks|Enrolled participants who received at least 1 dose of study drug and had a Week 50 PGI-I assessment.|||units on a scale||Standard Deviation|Mean
2655915|NCT01621191|Primary|Number of Participants Who Experienced an Adverse Event (AE)|A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through 53 weeks|Enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2655916|NCT01621178|Secondary|Participants With Events of Allergic/Hypersensitivity Reactions|Participants with Events of Allergic/Hypersensitivity Reactions: Angioedema Standardized MedDRA Query (SMQ), Anaphylactic Reaction SMQ, or Severe Cutaneous Adverse Reactions SMQ|Baseline through 52 Weeks|All randomized participants who received at least one dose of study drug.|||participants with events|||Number
2655917|NCT01621178|Secondary|Rate of Hypoglycemic Events (HE)|HE were classified as total HE rate, documented symptomatic hypoglycemia, severe hypoglycemia, and nocturnal. The 1-year adjusted rate of HEs was summarized cumulatively at 52 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline through 52 Weeks|All randomized participants who had received at least one dose of study drug and had evaluable post-baseline HE rate data. Only measurements prior to rescue or study drug discontinuation were used.|||Events/Participant/Year||Standard Deviation|Mean
2655943|NCT01621178|Secondary|Percentage of Participants Whose HbA1c Was <7.0%|Percentage of participants whose HbA1c was <7.0% based on last observation carried forward (LOCF).|26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used|||percentage of participants|||Number
2655918|NCT01621178|Secondary|Percentage of Participants With Self-Reported Hypoglycemic Events (HE)|Hypoglycemic events (HE) were classified as severe (defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of ≤3.9 mmol/L (≤70 mg/dL), nocturnal (defined as any hypoglycemic event that occurs between bedtime and waking). The number of self-reported hypoglycemic events was summarized cumulatively at 52 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline through 52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable post-baseline HE data. Only measurements prior to rescue or study drug discontinuation were used.|||percentage of participants|||Number
2655919|NCT01621178|Secondary|Change From Baseline in Body Weight|LS means were calculated from a REML based MMRM model: Change from Baseline = treatment , week, treatment*Week, MA-region, Baseline HbA1c (%), Baseline Body Weight (kg), Baseline CKD Severity, Log Baseline eGFR (within CKD severity), where participant enters the model as a random effect. Covariance structure = Unstructured.|Baseline, 52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline body weight data. Only measurements prior to rescue or study drug discontinuation were used.|||kg||Standard Error|Least Squares Mean
2655920|NCT01621178|Secondary|Change From Baseline in UACR|The change from baseline in UACR|Baseline, 52 Weeks|All randomized participants who received one dose of study drug and had evaluable baseline and post-baseline UACR data.|||g/kg||Inter-Quartile Range|Median
2655921|NCT01621178|Secondary|Change From Baseline in eCrCl|eCrCl was calculated by Cockcroft-Gault [Cockcroft and Gault 1976] equation using baseline estimated lean body weight.|Baseline, 52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline eCrCl data.|||mL/min||Inter-Quartile Range|Median
2655922|NCT01621178|Secondary|Change From Baseline in eGFR|The change in eGFR by using CKD-EPI equation.|Baseline, 52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline eGFR data.|||mL/min/1.73m2||Inter-Quartile Range|Median
2655923|NCT01621178|Secondary|Change From Baseline in sCr|Change from baseline in sCr levels after treatment.|Baseline, 52 Weeks|All randomized participants who received one dose of study drug and had evaluable baseline and post-baseline sCr data.|||mg/dL||Inter-Quartile Range|Median
2655924|NCT01621178|Secondary|Percentage of Participants With Estimated Average Glucose <154 mg/dL|Percentage of Participants With Estimated Average Glucose <154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF).|52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable HbA1c and average self-monitored plasma glucose post-baseline data. Only measurements prior to rescue or study drug discontinuation were used.|||percentage of participants|||Number
2655925|NCT01621178|Secondary|Change in Mean Daily Insulin Lispro Dose|The mean daily insulin was based on a 4-week interval prior to week 52 assessments. LS means were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in mean daily insulin as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment*week, log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.|Baseline, 52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline HbA1c and insulin lispro dose data. Only measurements prior to rescue or study drug discontinuation were used.|||U/day||Standard Error|Least Squares Mean
2655926|NCT01621178|Secondary|Change From Baseline in FG|LS means were calculated using MMRM with the change in FG as the dependent variable and treatment, MA -region, Baseline CKD Severity, week, treatment*week, baseline FG, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured|Baseline, 52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c and FG data. Only measurements prior to rescue or study drug discontinuation were used.|||mg/dL||Standard Error|Least Squares Mean
2655927|NCT01621178|Secondary|Change From Baseline in 8-Point SMPG|The daily mean of 8-point SMPG profile at Week 52 is presented. Participants were required to perform two 8-point SMPG profiles over a 1-week period at 5 separate times throughout the study. LS means were calculated using the MMRM model including the corresponding baseline value as a continuous covariate, as well as baseline HbA1c, MA-region, treatment, week, treatment*week, baseline CKD severity, and log baseline eGFR (within CKD severity).The two 8-point SMPG profiles were collected on two non-consecutive days (pre-meal and 2-hour postprandial SMPG x [morning, midday, and evening meals in one day] + bedtime + 5 hours after bedtime).|Baseline, 52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c and SMPG data. Only measurements prior to rescue or study drug discontinuation were used.|||mg/dL||Standard Error|Least Squares Mean
2655928|NCT01621178|Secondary|Percentage of Participants Whose HbA1c is <8.0%|Percentage of participants whose HbA1c was <8.0% based on last observation carried forward (LOCF).|52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used.|||percentage of participants|||Number
2655929|NCT01621178|Secondary|Percentage of Participants Whose HbA1c is <7.0%|Percentage of participants whose HbA1c was <7.0% based on last observation carried forward (LOCF).|52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used.|||percentage of participants|||Number
2655930|NCT01621178|Secondary|Change From Baseline in HbA1c|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS means in HbA1c were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, MA region, Baseline CKD Severity, week, treatment*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.|Baseline, 52 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used.|||percentage of HbA1c||Standard Error|Least Squares Mean
2655931|NCT01621178|Secondary|Rate of Hypoglycemic Events|Hypoglycemic events (HE) were classified as total HE rate, documented symptomatic hypoglycemia, severe hypoglycemia, and nocturnal. The 1-year adjusted rate of HEs was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline through 26 Weeks|All randomized participants who had received at least one dose of study drug and had evaluable post-baseline HE rate data. Only measurements prior to rescue or study drug discontinuation were used.|||Events/Participant/Year||Standard Deviation|Mean
2655932|NCT01621178|Secondary|Percentage of Participants With Self-Reported Hypoglycemic Events (HE)|Hypoglycemic events (HE) were classified as severe (defined as an episode requiring the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of ≤3.9 mmol/L (≤70 mg/dL), nocturnal (defined as any hypoglycemic event that occurs between bedtime and waking). The number of self-reported hypoglycemic events was summarized cumulatively at 26 weeks. A summary of other nonserious AEs, and all SAEs, regardless of causality, is located in the Reported Adverse Events section.|Baseline through 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable post-baseline HE data. Only measurements prior to rescue or study drug discontinuation were used.|||percentage of participants|||Number
2655933|NCT01621178|Secondary|Change From Baseline in Body Weight|"LS means were calculated from a REML based MMRM model: Change from Baseline = treatment, week, treatment*Week, MA-region, Baseline HbA1c (%), Baseline Body Weight (kg), Baseline CKD Severity, Log Baseline eGFR (within CKD severity), where participant enters the model as a random effect. Covariance structure = Unstructured.~•"|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline body weight data. Only measurements prior to rescue or study drug discontinuation were used.|||kilogram (kg)||Standard Error|Least Squares Mean
2655934|NCT01621178|Secondary|Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR)|The change from baseline in Urinary Albumin to Creatinine Ratio (UACR).|Baseline, 26 Weeks|All randomized participants who received one dose of study drug and had evaluable baseline and post-baseline UACR data.|||gram/kilogram (g/kg)||Inter-Quartile Range|Median
2655935|NCT01621178|Secondary|Change From Baseline in Estimated Creatinine Clearance (eCrCl)|Estimated creatinine clearance (eCrCl) was calculated by Cockcroft-Gault [Cockcroft and Gault 1976] equation using baseline estimated lean body weight.|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline eCrCl data.|||milliliter/minute (ml/min)||Inter-Quartile Range|Median
2655936|NCT01621178|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)|The change in estimated glomerular filtration rate (eGFR) by using CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline eGFR data.|||milliliter/minute/1.73m2 (mL/min/1.73m2)||Inter-Quartile Range|Median
2655937|NCT01621178|Secondary|Change From Baseline in Serum Creatinine (sCr)|Change from baseline in serum creatinine (sCr) levels after treatment.|Baseline, 26 Weeks|All randomized participants who received one dose of study drug and had evaluable baseline and post-baseline sCr data.|||mg/dL||Inter-Quartile Range|Median
2655938|NCT01621178|Secondary|Percentage of Participants With Estimated Average Glucose <154 mg/dL|Percentage of Participants With Estimated Average Glucose <154 milligram/deciliter (mg/dL) was based on last observation carried forward (LOCF).|26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable HbA1c and average self-monitored plasma glucose post-baseline data. Only measurements prior to rescue or study drug discontinuation were used.|||percentage of participants|||Number
2655939|NCT01621178|Secondary|Change From Baseline in Mean Daily Insulin Lispro Dose|The mean daily insulin was based on a 4-week interval prior to week 26 assessments. LS means were calculated using a REML based mixed-effects model for repeated measures (MMRM) with the change in mean daily insulin as the dependent variable and treatment, MA-region, Baseline HbA1c, baseline mean daily insulin, baseline CKD Severity, week, treatment*week, log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline HbA1c and insulin lispro dose data. Only measurements prior to rescue or study drug discontinuation were used.|||Units/day (U/day)||Standard Error|Least Squares Mean
2655940|NCT01621178|Secondary|Change From Baseline in Fasting Glucose (FG)|LS means were calculated using MMRM with the change in FG as the dependent variable and treatment, MA -region, Baseline CKD Severity, week, treatment*week, baseline FG, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline HbA1c and FG data. Only measurements prior to rescue or study drug discontinuation were used.|||milligram/deciliter (mg/dL)||Standard Deviation|Least Squares Mean
2655941|NCT01621178|Secondary|Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG)|The daily mean of 8-point SMPG profile at Week 26 is presented. Participants were required to perform two 8-point SMPG profiles over a 1-week period at 5 separate times throughout the study. LS means were calculated using the MMRM model including the corresponding baseline value as a continuous covariate, as well as baseline HbA1c, MA-region, treatment, week, treatment*week, baseline CKD severity, and log baseline eGFR (within CKD severity).The two 8-point SMPG profiles were collected on two non-consecutive days (pre-meal and 2-hour postprandial SMPG x [morning, midday, and evening meals in one day] + bedtime + 5 hours after bedtime).|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c and SMPG data. Only measurements prior to rescue or study drug discontinuation were used.|||milligrams/deciliter (mg/dL)||Standard Error|Least Squares Mean
2655942|NCT01621178|Secondary|Percentage of Participants Whose HbA1c Was <8.0%|Percentage of Participants whose HbA1c was <8.0% based on last observation carried forward (LOCF).|26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used.|||percentage of participants|||Number
2655944|NCT01621178|Primary|Change From Baseline in Hemoglobin A1c (HbA1c)|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) means in HbA1c were calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) with the change in HbA1c as the dependent variable and treatment, macroalbuminuria (MA) region, Baseline CKD Severity, week, treatment*week, baseline HbA1c (%), log baseline eGFR (within CKD severity), and participant was the random effect. Covariance structure = Unstructured.|Baseline, 26 Weeks|All randomized participants who received at least one dose of study drug and had evaluable baseline and post-baseline HbA1c data. Only measurements prior to rescue or study drug discontinuation were used.|||percentage of HbA1c||Standard Error|Least Squares Mean
2655945|NCT01621126|Primary|Neurologic Complication Rate After Latarjet Procedure|Nerve palsy of any nerve(s) in the operative upper extremity.|up to 24 weeks after the procedure||||participants|||Number
2655946|NCT01621009|Primary|7-day Point Prevalence Abstinence From Smoking at 6 Months|No smoking, not even a puff, during the 7 days prior to the 6 month follow-up. Biochemically confirmed.|6 months|Full intent-to-treat sample|||Number of abstinent participants|||Number
2655947|NCT01620983|Secondary|Short Physical Performance Battery|The Short Physical Performance Battery measures actual physical performance of four common daily physical activities including standing balance, single standing from a chair, repeated standing from a chair, and a 4 meter walk test. Scores range from 0 to 12 with higher scores indicating better physical performance.|twelve months|Data from all subjects were analysed.|||units on scale||95% Confidence Interval|Mean
2655948|NCT01620983|Secondary|Six-minute Walk Test|Distance walked in six minutes.|twelve months|Data from all subjects were analysed.|||meters||95% Confidence Interval|Mean
2655949|NCT01620983|Secondary|Global Rating of Change Scale|11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery.|twelve months|Data from all subjects were analysed.|||units on scale||95% Confidence Interval|Mean
2655950|NCT01620983|Secondary|Pain Catastrophizing Scale|A scale that quantifies the extent to which a participant catastrophizes about their pain. Score range from 0 to 52 with higher scores denoting greater pain catastrophizing.|twelve months|Data from all subjects were included in the analyses.|||units on scale||95% Confidence Interval|Mean
2655951|NCT01620983|Secondary|0 to 10 Verbal Pain Rating Scale|An 11 point verbal pain rating scale with higher scores denoting higher pain intensity.|twelve months|Data from all subjects were included in the analyses.|||units on scale||95% Confidence Interval|Mean
2655952|NCT01620983|Secondary|WOMAC Physical Function Scale|A self report scale that quantifies the extent of difficulty with everyday activity. The scale ranges from 0 to 68 with higher scores denoting greater difficulty with daily function.|twelve months|Data from all subjects were included in the analyses.|||units on scale||95% Confidence Interval|Mean
2655953|NCT01620983|Primary|Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale|A self report scale that quantifies the extent of function limiting pain. The scale ranges from 0 to 20 with higher scores denoting worse activity related pain.|twelve months|Data from all subjects were included in primary and secondary analyses.|||units on scale||95% Confidence Interval|Mean
2655954|NCT01620762|Secondary|Number of Days With no Moderate or Severe TRSS Symptoms Without Rescue Medication Use|The number of well days, i.e., days with no moderately or severely annoying symptoms and with no rescue medication used was calculated for all subjects over a period of approximately 21 days, 52-54 weeks after randomisation.|52-54 week after randomisaiton|Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.|||days||Standard Error|Least Squares Mean
2655955|NCT01620762|Secondary|Mean RQLQ Score in Cat-PAD Compared With Placebo|"The RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) was completed by subjects at the end of the study (52-54 weeks after randomisation).~The RQLQ is a validated method of assessing quality of life and has 28 questions in seven domains (activity limitation, sleep problems, nasal symptoms, eye symptoms, non-nasal/eye symptoms, practical problems and emotional function). Subjects recalled how their rhinoconjunctivitis had been during the last week and responded to each question on a seven-point scale (0 = no impairment, 6 = maximum impairment). The questions were equally weighted, and the RQLQ score was the mean of the 28 questions and could range from zero to six."|52-54 weeks after randomisation|Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2655956|NCT01620762|Secondary|Mean RMS in Cat-PAD Compared With Placebo|"Mean RMS (Rescue medication score) in Cat-PAD treatment groups compared with placebo groups.~The use of rhinoconjunctivitis rescue medications was recorded by the subject on a daily basis just before bedtime for approximately 21 days, 52-54 weeks after randomisation and was scored based on a previously published system as follows: 0 = no allergy rescue medication used per day; 0.5 = at least one dose of antihistamine eye drops used per day; 1 = at least one dose of oral antihistamine used per day; 2 = at least one dose of intranasal corticosteroid used per day; 3 = at least one dose of systemic corticosteroid used per day. The score was according to the highest level of rescue medication used and was not additive."|52-54 weeks after randomisation|Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2655957|NCT01620762|Secondary|Mean Daily TOSS in Cat-PAD Compared to Placebo|"Mean daily Total Ocular Symptom Score (TOSS) in Cat-PAD treatment groups compared to placebo groups~TOSS was the sum of all the ocular symptom scores (itchy eyes; watery eyes; red eyes; sore eyes) and could range from 0 to 12. Higher TOSS reflected more severe symptoms.~Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks. 52-54 weeks after randomisation."|52-54 weeks after randomisation|Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2656038|NCT01620528|Secondary|Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 3 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||percentage change||Standard Error|Least Squares Mean
2655958|NCT01620762|Secondary|Mean Daily TNSS in Cat-PAD Compared With Placebo|"TNSS (Total nasal symptom score) was the sum of all the nasal symptom scores (runny nose; sneezing; blocked nose; itchy nose) and could range from 0 to 12. Higher TNSS reflected more severe symptoms.~Subjects rated the severity of each symptom over the last 24 hours as follows: 0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome. Symptoms were scored daily for a period of approximately 3 weeks. 52-54 weeks after randomisation."|52-54 weeks after randomisation|Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2655959|NCT01620762|Secondary|Mean TRSS|"Mean Total Rhinoconjunctivitis Symptom Score (TRSS) in Cat-PAD treatment groups compared with placebo.~Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes, and sore eyes. Each symptom was rated in severity on a score of 0-3 (0. absent; 1. mild, barely noticeable; 2. moderate, annoying/troublesome; 3. severe, very annoying/very troublesome), therefore TRSS could range from 0 to 24. Higher TRSS reflected more severe symptom scores. Symptoms were scored daily for a period of approximately 3 weeks. 52-54 weeks after randomisation."|52-54 weeks after randomisation|Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2655960|NCT01620762|Primary|Mean Combined Score in Cat-PAD Treatment Groups Compared With Placebo|"The primary endpoint was the mean Combined Score (CS) measured over a 3 week period (52-54 weeks after randomisation) in the Cat-PAD treatment groups compared with the mean CS in the placebo group. A higher score indicated worse symptoms or greater use of medication and thus a low score indicated a better outcome.~CS = Total Rhinoconjunctivitis Symptom Score (TRSS) + Rescue Medication Score (RMS). Eight symptoms are defined in the TRSS, 4 nasal symptoms: runny nose, sneezing; blocked nose, and itchy nose and 4 ocular symptoms: itchy eyes; watery eyes; red eyes and sore eyes. Each symptom was rated in severity on a score of 0-3 (0=absent, 3=severe) and the total was divided by the number of symptoms to provide an average score per symptom of 0-3.~RMS was scored from 0 (no allergy rescue medication use per day) to 3 (at least one dose of systemic corticosteroid per day). The RMS score was not additive, and therefore the maximum RMS was 3 and the maximum CS was 6."|52-54 weeks after randomisation|Only those subjects in the intent to treat (ITT) population with data at the end of the study were included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2655961|NCT01620593|Secondary|Number of Participants With Adverse Events|"The safety and tolerability of metformin with castration therapy as compared to castration therapy alone as measured by the number of subjects experiencing adverse events using CTCAE (common terminology criteria for adverse events) version 4 criteria. Grades are assigned to each adverse event where:~Grade 1 is mild symptoms Grade 2 is moderate symptoms Grade 3 is severe or medically significant but not immediately life-threatening symptoms Grade 4 is life-threatening consequences, where urgent intervention is indicated Grade 5 is death related to the adverse event"|1 year||||Participants|||Count of Participants
2655962|NCT01620593|Secondary|Treatment Failure|Progression time from randomization to the earliest disease progression defined as an increase of 20% or more as per RECIST criteria. Patients will not be removed from protocol treatment for PSA progression alone in the first 12 weeks on this study. Further rise in PSA even in the absence of deterioration of pre-existing lesions will constitute treatment failure. Adverse event leading to withdrawal related to metformin or placebo or castration treatment. Death from any cause. Patients unwillingness to continue. Patient's non-compliance with taking the study intervention - 50% or higher.|1 year|Outcome was not measured||||||
2655963|NCT01620593|Secondary|PSA Response|Complete Response for PSA measure was defined as a PSA less than or equal to 4 ng/ml or undetectable value at 7 months.|28 weeks||||ng/ml||Standard Deviation|Mean
2655964|NCT01620593|Primary|Metabolic Syndrome Waist Circumference|Compare both cohorts of castrated men (metformin vs. placebo) with regard to metabolic consequences of castration therapy:change in waist circumference.|Change from 12 to 28 weeks||||centimeters||Full Range|Mean
2655965|NCT01620593|Primary|Metabolic Syndrome|Compare both cohorts of castrated men (metformin vs. placebo) with regard to metabolic consequences of castration therapy:change in weight.|Change from 0 weeks to 28 weeks|Only subjects that completed the study were analyzed|||kilograms||Full Range|Mean
2655966|NCT01620567|Secondary|Inflammation|C-reactive protein|6 month||||mg/L||Standard Deviation|Mean
2655967|NCT01620567|Secondary|Inflammation|C-reactive protein|3 month||||mg/L||Standard Deviation|Mean
2655968|NCT01620567|Secondary|Inflammation|C-reactive protein|0 months||||mg/L||Standard Deviation|Mean
2655969|NCT01620567|Primary|Cognition|measures of sustained attention will be made using CANTAB, a sensitive computerized program. Signal detection measured on a scale from 0 to 1(bad to good).|6 months||||units on a scale||Standard Deviation|Mean
2655970|NCT01620528|Secondary|Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type||Up to Month 6 of Treatment Period|The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug.|||Participants|||Count of Participants
2655971|NCT01620528|Secondary|Number of Days of Hospitalization||Up to Month 6 of Treatment Period|The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Includes participants who were hospitalized during the Treatment Period.|||days||Standard Deviation|Mean
2655972|NCT01620528|Secondary|Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period||Up to Month 6 of Treatment Period|The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug.|||Participants|||Count of Participants
2655973|NCT01620528|Secondary|Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.|Baseline, Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655974|NCT01620528|Secondary|Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.|Baseline, Month 5 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655975|NCT01620528|Secondary|Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.|Baseline, Month 4 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655976|NCT01620528|Secondary|Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.|Baseline, Month 3 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655977|NCT01620528|Secondary|Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.|Baseline, Month 2 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655978|NCT01620528|Secondary|Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.|Baseline, Month 1 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655979|NCT01620528|Secondary|Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.|Baseline, Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655980|NCT01620528|Secondary|Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.|Baseline, Month 5 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655981|NCT01620528|Secondary|Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.|Baseline, Month 4 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655982|NCT01620528|Secondary|Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.|Baseline, Month 3 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655983|NCT01620528|Secondary|Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.|Baseline, Month 2 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655984|NCT01620528|Secondary|Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.|Baseline, Month 1 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655985|NCT01620528|Secondary|Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.|Baseline, Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655986|NCT01620528|Secondary|Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.|Baseline, Month 5 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655987|NCT01620528|Secondary|Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.|Baseline, Month 4 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655988|NCT01620528|Secondary|Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.|Baseline, Month 3 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655989|NCT01620528|Secondary|Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.|Baseline, Month 2 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655990|NCT01620528|Secondary|Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration.|Baseline, Month 1 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655991|NCT01620528|Secondary|Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.|Baseline, Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655992|NCT01620528|Secondary|Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.|Baseline, Month 5 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655993|NCT01620528|Secondary|Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.|Baseline, Month 4 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655994|NCT01620528|Secondary|Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.|Baseline, Month 3 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655995|NCT01620528|Secondary|Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.|Baseline, Month 2 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655996|NCT01620528|Secondary|Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration.|Baseline, Month 1 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655997|NCT01620528|Secondary|Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.|Baseline, Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655998|NCT01620528|Secondary|Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.|Baseline, Month 5 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2655999|NCT01620528|Secondary|Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.|Baseline, Month 4 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2656000|NCT01620528|Secondary|Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.|Baseline, Month 3 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2656001|NCT01620528|Secondary|Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.|Baseline, Month 2 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2656002|NCT01620528|Secondary|Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.|Baseline, Month 1 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2656003|NCT01620528|Secondary|Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.|Baseline, Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2656004|NCT01620528|Secondary|Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.|Baseline, Month 5 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2656005|NCT01620528|Secondary|Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.|Baseline, Month 4 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2656006|NCT01620528|Secondary|Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.|Baseline, Month 3 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2656007|NCT01620528|Secondary|Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.|Baseline, Month 2 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2656008|NCT01620528|Secondary|Change From Baseline to Month 1 in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism|The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.|Baseline, Month 1 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||hours||Standard Error|Least Squares Mean
2656009|NCT01620528|Secondary|Change From Baseline to Month 6 in the Sexual Intercourse Domain of the EHP-30|The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.|Baseline, Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2656039|NCT01620528|Secondary|Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 2 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||percentage change||Standard Error|Least Squares Mean
2656010|NCT01620528|Secondary|Change From Baseline to Month 3 in the Sexual Intercourse Domain of the EHP-30|The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.|Baseline, Month 3 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2656011|NCT01620528|Secondary|Change From Baseline to Month 1 in the Sexual Intercourse Domain of the EHP-30|The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.|Baseline, Month 1 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2656012|NCT01620528|Secondary|Change From Baseline to Month 6 in the Pain Domain of the EHP-30|The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.|Baseline, Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2656013|NCT01620528|Secondary|Change From Baseline to Month 3 in the Pain Domain of the EHP-30|The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.|Baseline, Month 3 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2656014|NCT01620528|Secondary|Change From Baseline to Month 1 in the Pain Domain of the Endometriosis Health Profile-30 (EHP-30)|The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.|Baseline, Month 1 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2656015|NCT01620528|Secondary|Change From Baseline to Month 6 in NRS Scores|The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).|Baseline, Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2656016|NCT01620528|Secondary|Change From Baseline to Month 5 in NRS Scores|The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).|Baseline, Month 5 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2656017|NCT01620528|Secondary|Change From Baseline to Month 4 in NRS Scores|The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).|Baseline, Month 4 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2656018|NCT01620528|Secondary|Change From Baseline to Month 2 in NRS Scores|The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).|Baseline, Month 2 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2656019|NCT01620528|Secondary|Change From Baseline to Month 1 in NRS Scores|The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).|Baseline, Month 1 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2656020|NCT01620528|Secondary|Response to PGIC at Month 6|The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.|Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2656021|NCT01620528|Secondary|Response to PGIC at Month 5|The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.|Month 5 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2656022|NCT01620528|Secondary|Response to PGIC at Month 4|The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.|Month 4 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2656023|NCT01620528|Secondary|Response to PGIC at Month 3|The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.|Month 3 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2656087|NCT01620255|Secondary|Maximum Serum PF-00547659 Concentration Achieved||Weeks 0 (baseline), 2, 4,8, 12, 16, 20, 24, 28, 32, and 36; Early Withdrawal|Participants who received active treatment (PF-00547659) were included in this analysis.|||nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
2656024|NCT01620528|Secondary|Response to PGIC at Month 2|The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.|Month 2 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2656025|NCT01620528|Secondary|Response to Patient Global Impression of Change (PGIC) at Month 1|The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.|Month 1 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2656026|NCT01620528|Secondary|Change From Baseline to Month 5 in Analgesic Use Across Both Classes of Rescue Analgesics|Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.|Baseline, Month 5 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||pills||Standard Error|Least Squares Mean
2656027|NCT01620528|Secondary|Change From Baseline to Month 4 in Analgesic Use Across Both Classes of Rescue Analgesics|Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.|Baseline, Month 4 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||pills||Standard Error|Least Squares Mean
2656028|NCT01620528|Secondary|Change From Baseline to Month 2 in Analgesic Use Across Both Classes of Rescue Analgesics|Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.|Baseline, Month 2 of Treatment Period|The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||pills||Standard Error|Least Squares Mean
2656029|NCT01620528|Secondary|Change From Baseline to Month 1 in Analgesic Use Across Both Classes of Rescue Analgesics|Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.|Baseline, Month 1 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||pills||Standard Error|Least Squares Mean
2656030|NCT01620528|Secondary|Change From Baseline to Month 6 in Mean Pain Score of DYSP|The DYSP pain scale ranged from 0 (absent) to 3 (severe).|Baseline, Month 6 of Treatment Period|"The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded not applicable for the entire time point and at Baseline are excluded from the analysis."|||units on a scale||Standard Error|Least Squares Mean
2656031|NCT01620528|Secondary|Change From Baseline to Month 5 in Mean Pain Score of DYSP|The DYSP pain scale ranged from 0 (absent) to 3 (severe).|Baseline, Month 5 of Treatment Period|"The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded not applicable for the entire time point and at Baseline are excluded from the analysis."|||units on a scale||Standard Error|Least Squares Mean
2656032|NCT01620528|Secondary|Change From Baseline to Month 4 in Mean Pain Score of DYSP|The DYSP pain scale ranged from 0 (absent) to 3 (severe).|Baseline, Month 4 of Treatment Period|"The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded not applicable for the entire time point and at Baseline are excluded from the analysis."|||units on a scale||Standard Error|Least Squares Mean
2656033|NCT01620528|Secondary|Change From Baseline to Month 2 in Mean Pain Score of DYSP|The DYSP pain scale ranged from 0 (absent) to 3 (severe).|Baseline, Month 2 of Treatment Period|"The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded not applicable for the entire time point and at Baseline are excluded from the analysis."|||units on a scale||Standard Error|Least Squares Mean
2656034|NCT01620528|Secondary|Change From Baseline to Month 1 in Mean Pain Score of DYSP|The DYSP pain scale ranged from 0 (absent) to 3 (severe).|Baseline, Month 1 of Treatment Period|"The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded not applicable for the entire time point and at Baseline are excluded from the analysis."|||units on a scale||Standard Error|Least Squares Mean
2656035|NCT01620528|Secondary|Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||percentage change||Standard Error|Least Squares Mean
2656036|NCT01620528|Secondary|Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 5 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||percentage change||Standard Error|Least Squares Mean
2656037|NCT01620528|Secondary|Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 4 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||percentage change||Standard Error|Least Squares Mean
2657977|NCT01601873|Secondary|Number of Postoperative Re-interventions||at least 1 year but up to two years|2 in the propaten group and 3 in the standard graft group were lost to follow up.|||post-operative re-interventions||Standard Deviation|Mean
2656040|NCT01620528|Secondary|Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 1 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||percentage change||Standard Error|Least Squares Mean
2656041|NCT01620528|Secondary|Change From Baseline to Month 5 in Mean Pain Score for NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 5 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases|||units on a scale||Standard Error|Least Squares Mean
2656042|NCT01620528|Secondary|Change From Baseline to Month 4 in Mean Pain Score for NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 4 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases|||units on a scale||Standard Error|Least Squares Mean
2656043|NCT01620528|Secondary|Change From Baseline to Month 3 in Mean Pain Score for NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 3 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases|||units on a scale||Standard Error|Least Squares Mean
2656044|NCT01620528|Secondary|Change From Baseline to Month 2 in Mean Pain Score for NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 2 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases|||units on a scale||Standard Error|Least Squares Mean
2656045|NCT01620528|Secondary|Change From Baseline to Month 1 in Mean Pain Score for NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 1 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases|||units on a scale||Standard Error|Least Squares Mean
2656046|NCT01620528|Secondary|Percent Change From Baseline to Month 6 in Mean Pain Score for DYS|The DYS pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||percentage change||Standard Error|Least Squares Mean
2656047|NCT01620528|Secondary|Percent Change From Baseline to Month 5 in Mean Pain Score for DYS|The DYS pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 5 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||percentage change||Standard Error|Least Squares Mean
2656048|NCT01620528|Secondary|Percent Change From Baseline to Month 4 in Mean Pain Score for DYS|The DYS pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 4 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||percentage change||Standard Error|Least Squares Mean
2656049|NCT01620528|Secondary|Percent Change From Baseline to Month 3 in Mean Pain Score for DYS|The DYS pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 3 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||percentage change||Standard Error|Least Squares Mean
2656050|NCT01620528|Secondary|Percent Change From Baseline to Month 2 in Mean Pain Score for DYS|The DYS pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 2 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||percentage change||Standard Error|Least Squares Mean
2656051|NCT01620528|Secondary|Percent Change From Baseline to Month 1 in Mean Pain Score for DYS|The DYS pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 1 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||percentage change||Standard Error|Least Squares Mean
2656052|NCT01620528|Secondary|Change From Baseline to Month 5 in Mean Pain Score for DYS|The DYS pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 5 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2656053|NCT01620528|Secondary|Change From Baseline to Month 4 in Mean Pain Score for DYS|The DYS pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 4 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2656054|NCT01620528|Secondary|Change From Baseline to Month 3 in Mean Pain Score for DYS|The DYS pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 3 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2656055|NCT01620528|Secondary|Change From Baseline to Month 2 in Mean Pain Score for DYS|The DYS pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 2 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2656056|NCT01620528|Secondary|Change From Baseline to Month 1 in Mean Pain Score for DYS|The DYS pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 1 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2656057|NCT01620528|Secondary|Percentage of Responders at Month 6 for DYSP|The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.|At Month 6 of the Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||percentage of participants|||Number
2656058|NCT01620528|Secondary|Percentage of Responders at Month 5 for DYSP|The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.|At Month 5 of the Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||percentage of participants|||Number
2656059|NCT01620528|Secondary|Percentage of Responders at Month 4 for DYSP|The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.|At Month 4 of the Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||percentage of participants|||Number
2656060|NCT01620528|Secondary|Percentage of Responders at Month 2 for DYSP|The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.|At Month 2 of the Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||percentage of participants|||Number
2656061|NCT01620528|Secondary|Percentage of Responders at Month 1 for DYSP|The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.|At Month 1 of the Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||percentage of participants|||Number
2656062|NCT01620528|Secondary|Percentage of Responders at Month 6 Based on Daily Assessment of NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.|At Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||percentage of participants|||Number
2656063|NCT01620528|Secondary|Percentage of Responders at Month 5 Based on Daily Assessment of NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.|At Month 5 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||percentage of participants|||Number
2656064|NCT01620528|Secondary|Percentage of Responders at Month 4 Based on Daily Assessment of NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.|At Month 4 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||percentage of participants|||Number
2656065|NCT01620528|Secondary|Percentage of Responders at Month 2 Based on Daily Assessment of NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.|At Month 2 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||percentage of participants|||Number
2656066|NCT01620528|Secondary|Percentage of Responders at Month 1 Based on Daily Assessment of NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.|At Month 1 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||percentage of participants|||Number
2656067|NCT01620528|Secondary|Percentage of Responders at Month 6 Based on Daily Assessment of DYS|The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.|At Month 6 of the Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||percentage of participants|||Number
2656068|NCT01620528|Secondary|Percentage of Responders at Month 5 Based on Daily Assessment of DYS|The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.|At Month 5 of the Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward..|||percentage of participants|||Number
2656069|NCT01620528|Secondary|Percentage of Responders at Month 4 Based on Daily Assessment of DYS|The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.|At Month 4 of the Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||percentage of participants|||Number
2656070|NCT01620528|Secondary|Percentage of Responders at Month 2 Based on Daily Assessment of DYS|The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.|At Month 2 of the Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||percentage of participants|||Number
2656071|NCT01620528|Secondary|Percentage of Responders at Month 1 Based on Daily Assessment of DYS|The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.|At Month 1 of the Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.|||percentage of participants|||Number
2656072|NCT01620528|Secondary|Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)|Permitted rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.|Baseline, Month 3 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||pills||Standard Error|Least Squares Mean
2656073|NCT01620528|Secondary|Change From Baseline to Month 3 in Dyspareunia (DYSP)|The DYSP pain scale ranges from 0 (absent) to 3 (severe).|Baseline, Month 3 of Treatment Period|"The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded not applicable for the entire time point and at Baseline are excluded from the analysis."|||units on a scale||Standard Error|Least Squares Mean
2666940|NCT01519934|Secondary|Subject Perception of Age|"Percentage of subjects rated as looking younger as measured using a Subject Perception of Age questionnaire."|Baseline to 180 days post-treatment||||percentage of participants|||Number
2656074|NCT01620528|Secondary|Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics|Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.|Baseline, Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||pills||Standard Error|Least Squares Mean
2656075|NCT01620528|Secondary|Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics|Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.|Baseline, Month 3 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||pills||Standard Error|Least Squares Mean
2656076|NCT01620528|Secondary|Change From Baseline to Month 6 in NMPP|The NMPP pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2656077|NCT01620528|Secondary|Change From Baseline to Month 6 in DYS|The DYS pain scale ranges from 0 (none) to 3 (severe).|Baseline, Month 6 of Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2656078|NCT01620528|Secondary|Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores|The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).|Baseline, Month 3 of the Treatment Period|The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.|||units on a scale||Standard Error|Least Squares Mean
2656079|NCT01620528|Primary|Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)|The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.|At Month 3 of Treatment Period|The mITT analysis set; all randomized participants who took at least 1 dose of randomized, double-blind study drug. Population included mITT participants who either had data during the Month 3 35-day window or who prematurely discontinued prior to or at Month 3 and met the rules for last observation carried forward.|||percentage of participants|||Number
2656080|NCT01620528|Primary|Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)|The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.|At Month 3 of the Treatment Period|The modified intent-to-treat (mITT) analysis set; all randomized participants who took at least 1 dose of randomized, double-blind study drug. Population included mITT participants who either had data during the Month 3 35-day window or who prematurely discontinued prior to or at Month 3 and met the rules for last observation carried forward.|||percentage of participants|||Number
2656081|NCT01620489|Secondary|Estimated Mean Ratio to Baseline and Observed Coefficient of Variation in Renal Function-estimated Glomerular Filtration Rate (eGFR) (to Check How Well the Kidneys Are Functioning Using Modification of Diet in Renal Disease (MDRD) Formula)|Calculated as the estimated ratio to baseline in eGFR (mL/min/1.73m˄2) after 26 Weeks of treatment based on the statistical model.|Week 0, week 26|Safety analysis set included all subjects receiving at least one dose of the trial product. A total of 8 subjects in the safety analysis set did not contribute to the analysis due to missing data.|||mL/min/1.73m˄2||Geometric Coefficient of Variation|Geometric Mean
2656082|NCT01620489|Secondary|Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Body Mass Index (BMI)|Calculated as estimated mean change in BMI (kg/m˄2) from baseline to Week 26 based on the statistical model.|Week 0, week 26|The FAS included all randomised subjects that received at least one dose of study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.|||kg/m^2||Standard Deviation|Mean
2656083|NCT01620489|Secondary|Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in Self-measured Plasma Glucose (SMPG) 7-point Profiles|SMPG was measured before and 90 minutes after breakfast, lunch and dinner and at bedtime at Week 0, 12 and 26. A summary measure of the 7 values was derived for each applicable visit as the area under the curve divided by the period of time elapsed between the first and last measurement. The change from baseline to week 26 was estimated using the statistical model.|Week 0, week 26|The FAS included all randomised subjects that received at least one dose of study medication. A total of 46 subjects in the FAS did not contribute to the analysis due to missing data.|||mmol/L||Standard Deviation|Mean
2656084|NCT01620489|Secondary|Estimated Proportion of Responders Achieving HbA1c <7.0% and no Minor or Severe Hypoglycaemic Episodes After 26 Weeks of Treatment|Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no minor or severe hypoglycaemic episodes observed within 26 weeks of treatment based on the statistical model.|At week 26|The FAS included all randomised subjects that received at least one dose of study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.|||percentage of patients|||Number
2656085|NCT01620489|Secondary|Estimated Proportion of Responders Achieving HbA1c <7.0% and no Weight Gain After 26 Weeks of Treatment|Calculated as estimated percentage of subjects achieving HbA1c <7.0% and no weight gain after 26 weeks of treatment based on the statistical model.|At week 26|The FAS included all randomised subjects that received at least one dose of study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.|||percentage of patients|||Number
2656086|NCT01620489|Primary|Estimated Mean From the Statistical Model and Standard Deviation From Observed Data For Change From Baseline to Week 26 in HbA1c (%) (Glycosylated Haemoglobin)|Calculated as the estimated mean change from baseline in HbA1c (%) after 26 Weeks of treatment based on the statistical model.|Week 0, Week 26|The full analysis set (FAS) included all randomised subjects that received at least one dose of the study medication. A total of 14 subjects in the FAS did not contribute to the analysis due to missing data.|||percentage (%)||Standard Deviation|Mean
2667069|NCT01519518|Secondary|CKMB Release Following Index Revascularisation Measured With a Single Estimation 12-18 Hours After the Procedure||28 days|||||||
2656088|NCT01620255|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Screening through to end of treatment period, up to 12 weeks|All randomized participants who received at least 1 dose of study treatment.|||participants|||Number
2656089|NCT01620255|Secondary|Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12|IBDQ: Psychometrically validated PRO instrument for measuring disease-specific QOL in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL. A score of >=170 corresponds to clinical remission.|Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment.|||percentage of participants||90% Confidence Interval|Number
2656090|NCT01620255|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12|IBDQ: Psychometrically validated PRO instrument for measuring disease-specific QOL in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL. There are 4 individual domains under the IBDQ: bowel function (fx)/symptoms (score range of 10-70), systemic symptoms (score range of 5-35), emotional status/fx (score range of 12-84), and social fx (score range of 5-35). As with total score, higher scores indicate better QOL in that domain.|Baseline (BL), Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at the specified time point for that specific domain.|||units on a scale||Standard Deviation|Mean
2656091|NCT01620255|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12|IBDQ: Psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL.|Baseline, Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
2656092|NCT01620255|Secondary|Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12|hsCRP was one of the PD biomarkers of the study.|Baseline; Weeks 4, 8, and 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at that specific time point.|||percent change||90% Confidence Interval|Geometric Mean
2656093|NCT01620255|Secondary|Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12|Fecal calprotectin was one of the pharmacodynamic (PD) biomarkers of the study.|Baseline, Weeks 4, 8, and 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at that specific time point.|||percent change||90% Confidence Interval|Geometric Mean
2656094|NCT01620255|Secondary|Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12|The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of <0, 0, and >0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore.|Baseline, Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at Week 12.|||percentage of participants|||Number
2656095|NCT01620255|Secondary|Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12|The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of less than (<) 0, 0, and >0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore.|Baseline; Weeks (W) 4, 8, and 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants at that specific time point for that endpoint.|||percentage of participants|||Number
2656120|NCT01619878|Secondary|Time to Gametocyte Clearance (GCT)|Time from first dose until first total and continued disappearance of gametocytes which remains at least a further 48 hours.|Up to 7 days|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.|||hours||Standard Deviation|Mean
2667070|NCT01519518|Primary|Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition||28 days||||percentage of total participants|||Number
2656096|NCT01620255|Secondary|Change From Baseline in Total Mayo Score at Week 12|The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.|Baseline, Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of evaluable participants in that specified category.|||units on a scale||Standard Deviation|Mean
2656097|NCT01620255|Secondary|Percentage of Participants With Absolute Partial Mayo Score of Less Than or Equal to (<=) 2 With no Individual Subscore More Than (>) 1 at Weeks 4, 8, and 12|"An absolute Partial Mayo Score of <=2 corresponds to remission. However, this endpoint was incorrectly stated in the protocol and instead of absolute Partial Mayo Score <=2, it was stated as change from baseline in Partial Mayo Score <=2."|Weeks 4, 8, and 12|As this endpoint was incorrectly stated in the protocol, no analyses were done and no data are presented.||||||
2656098|NCT01620255|Secondary|Percentage of Participants With Mucosal Healing at Week 12|Mucosal healing was defined as absolute Mayo subscore for endoscopy of 0 or 1. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.|Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment.|||percentage of participants||90% Confidence Interval|Number
2656099|NCT01620255|Secondary|Percentage of Participants With Clinical Response at Week 12|Clinical response was defined as a decrease from baseline of at least 3 points in Total Mayo Score with at least a 30 percent (%) change, accompanied by at least 1 point decrease or absolute score of 0 or 1 in rectal bleeding subscore. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.|Week 12|The primary analysis population was based on an mITT analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. n=number of participants evaluable for the specified category.|||percentage of participants||90% Confidence Interval|Number
2656100|NCT01620255|Primary|Percentage of Participants in Clinical Remission at Week 12|Clinical remission was defined as a Total Mayo Score of less than or equal (<=) 2 points with no individual subscore exceeding 1 point and rectal bleed subscore of 0 or 1. The Mayo Score is a tool designed to measure disease activity for ulcerative colitis (UC). Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.|Week 12|The primary analysis population was based on a modified intent-to-treat (mITT) analysis set, which was defined as all randomized participants who received at least 1 dose of randomized treatment. Two subjects initially randomized to the 22.5 mg group were mistakenly administered the 75 mg dose instead.|||percentage of participants||90% Confidence Interval|Number
2656101|NCT01620177|Secondary|THC Concentration Levels in Whole Blood|Measurement of THC concentration levels in whole blood over the course of each visit compared to that of the other visits.|-0.7 hr, 0.25hr, 1.1 hr, 2 hr, 3 hr, 4.5 hr, 6 hr, 8 hr post cannabis||||ng/ml||Full Range|Median
2656102|NCT01620177|Secondary|THC Concentration in Plasma Sample|Measurement of THC concentration levels in plasma over the course of each visit compared to that of the other visits.|-0.7 hr, 0.25hr, 1.1 hr, 2 hr, 3 hr, 4.5 hr, 6 hr, 8 hr post cannabis administration|We performed noncompartmental analyses with Phoenix WinNonLin® 6.3 for Windows (Pharsight) for maximum concentration (Cmax) of 11-OH-THC (LOQ 1 μg/L).|||ng/ml||Full Range|Median
2656103|NCT01620177|Primary|Driving Performance|Measured by standard deviation of lane position. Metrics of driving performance were modeled using the SAS GLM Select function to identify changes in driver performance. Numbers represents coefficients on the regression equation such that this increase would be expected for every unit increase. A unit for THC is 1 ng/ml and a unit for BAC is 0.01% BAC. In understanding the regression coefficients, for THC the units for the coefficient would be expressed as cm per (ng/ml of THC), and for BrAC the units for the coefficient would be expressed as cm per (0.01% BrAC). The overall regression equation would be represented as SDLP = Intercept + Cthc x THC + Cbrac x BrAC. The coefficients indicate the strength of the effect on driving performance with higher coefficients indicating larger effects relative to the concentrations. Coefficients of zero indicate no effect or interactive effect.|Through entire drive, 0.5-1.3 hr post cannabis administration.|One subject who was an extreme outlier across driving performance measures was excluded. Due to the variability in THC and BrAC levels across subjects and conditions, a regression model was used which combined all of the data.|||cm|||Number
2656104|NCT01620138|Primary|Tumor Volume Changes for NFPA and Prolactin Level Changes for Prolactinoma|Magnetic resonance imaging (MRI) of the sella and prolactin will be performed before (baseline) and after 6 months of treatment with cabergoline or pasireotide. Disease progression will be defined as tumor growth > 25%, stable disease as changes < 25% and significant tumor shrinkage as > 25% in tumor volume compared to baseline MRI (baseline to six months).|Baseline to six months||||cmˆ3||Full Range|Median
2656119|NCT01619982|Primary|Number of Patients Who Receive Preoperative Vancomycin and Cefazolin Who Develop a Surgical Site Infection Compared to Those Whose Received Only Cefazolin.|Number of patients who receive preoperative vancomycin and cefazolin who develop a surgical site infection (SSI) compared to those whose received only cefazolin. Surveillance was done with standard procedures and definitions.|Patients will be monitored for superficial SSIs for 30 days from the date of surgery. Patients will be monitored for 30 days for deep SSIs if no foreign material was implanted and for 1 year if foreign material is present.|Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients undergoing cardiopulmonary bypass|||participants|||Number
2656105|NCT01620086|Secondary|Depression Level Changes as Measured by the Hamilton Depression Inventory (HAMD).|HAM-D is a multiple choice questionnaire that clinicians administer to rate the severity of a subject's depression. There are 17 questions; each question has between 3-5 possible responses which increase in severity (range 0 to 52). The clinician chooses the correct response by interviewing the subject and by observing the symptoms. A score of 0-7 is considered to be normal, scores of 20 or higher indicate moderately severe depression. Change in the average results of this test between the baseline and active treatment weeks (1 and 10 Hz) will be measured.|"change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)"|Data are not collected on this outcome measure for controls. Data was missing for one patient in the active 1 Hz treatment condition.|||units on a scale||Standard Deviation|Mean
2656106|NCT01620086|Secondary|Overall Change in the Percent Habituation of the P50 Evoked Response Potential at 250 Inter Stimulus Interval (ISI) Between the Control and Active Treatments (1 and 10 Hz).|Percent habituation refers to change in the amplitude of the P50 evoked response potential following a 250 ms inter stimulus interval. Change in the average results of this test between the baseline and active treatment weeks (1 and 10 Hz) will be measured.|"change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)"|Three patients had missing data for the control site - baseline condition and the active 1 Hz treatment site -baseline conditions. One patient had missing data for the active 10 Hz treatment site - baseline.|||percent of change in wave amplitude||Standard Deviation|Mean
2656107|NCT01620086|Primary|Changes in Auditory Hallucinations Questionnaire (AHQ).|The Auditory Hallucinations Questionnaire (AHQ) will be used to determine the patient's perceptions of change in auditory hallucinations(s). Normal controls do not fill out this measure because they do not have auditory hallucinations. Change in the average results of this test between the baseline and active treatment weeks (1 and 10 Hz) will be measured. The range of scores is 0-70, higher scores mean more symptoms.|"change between the baseline time point and 4 days of active treatment (patients) or 2 days of sham or active treatment (controls)"|Data are not collected on this outcome measure for controls. Data was missing for one patient in the active 1 Hz treatment condition.|||units on a scale||Standard Deviation|Mean
2656108|NCT01620060|Secondary|Number of Participants With Serious Adverse Events and Non-serious Adverse Events|Serious adverse event and adverse events data will be listed and summarized as per MedDRA V15.0|11 Days||||participants|||Number
2656109|NCT01620060|Primary|Lurasidone Peak Serum Concentration (Cmax)|Cmax will be listed and summarized in tabular format|Day 1 - pre-dose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, and 48 hours. Day 10/12: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours||||ng/mL||Standard Deviation|Mean
2656110|NCT01620060|Primary|Lurasidone Primary Pharmacokinetic Parameters|Lurasidone AUClast (Day 1) and AUC0-∞ (Day 1) AUC0-24 (Day 10 or Day 12)|Day 1 - pre-dose, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, and 48 hours. Day 10/12: 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours|"Participants for PK analysis included all subjects who received at least 1 dose of study drug and had at least 1 measured concentration at a scheduled PK timepoint after start of dosing for at least 1 PK analyte.~For some PK parameters, some subjects didn't have PK data."|||ng.h/mL||Standard Deviation|Mean
2656111|NCT01620047|Secondary|Serum Fentanyl Levels|To identify a difference in serum fentanyl levels among the groups.|24 hours post-surgery|||||||
2656112|NCT01620047|Secondary|VAS Scores and Postoperative Supplemental Morphine Consumption|"Secondary Objective~To determine the amount of required supplemental analgesia during the postoperative period.~To determine postoperative analgesia using a Visual Analog Scale (VAS) 0 - 10 centimeter line."|24 hours post-surgery|||||||
2656113|NCT01620047|Primary|Comparison of Postoperative Strength (Extension)|To assess extension force postoperatively to discern differences in muscle strength retention between continuous femoral nerve sheath catheter administration of fentanyl or Ropivacaine or a continuous IV infusion of fentanyl.|24 hours post-surgery|Per protocol|||Nm/kg||Full Range|Median
2656114|NCT01619982|Secondary|Count of Participants Experiencing Adverse Events Commonly Associated With Peri-operative Vancomycin Prophylaxis|"Will evaluate for vancomycin associated pre or intraoperative adverse events:~Hypotension requiring treatment~Rash, flushing or Red Man's syndrome~Other changes in vital signs (decrease in baseline 02 sat, increased heart or respiratory rate, elevated body temperature) felt to be associated with vancomycin administration~An event associated with vancomycin administration which results in delay in surgery"|Adverse events to vancomycin will be assessed on each patient in the study during the time the patient is in the operating room (0-<24 hours)|Only the Cefazolin 25 mg/kg Body Weight and Vancomycin groups were assessed, the Cefazolin 30mg/kg body weight did not receive vancomycin|||Participants|||Count of Participants
2656115|NCT01619982|Secondary|Vancomycin Pharmacokinetics (Plasma Concentration vs Time Curve) in Children on Cardiopulmonary Bypass (CPB)|Vancomycin pharmacokinetics measured as Elimination Clearance, Inter-tissue Clearance (Fast), Inter-tissue Clearance (Slow).|Drug levels will be sampled only during the peri-operative time period (0 to 12 hours)|Vancomycin pharmacokinetics were assessed only in the Cefazolin 25 mg/kg body weight and Vancomycin arm|||L/min||95% Confidence Interval|Median
2656116|NCT01619982|Secondary|Vancomycin Pharmacokinetics (Plasma Concentration vs Time Curve) in Children During the Peri-operative Period in Infants Undergoing Cardiac Surgery With Cardiopulmonary Bypass (CPB)|Vancomycin pharmacokinetics measured as Central Volume, Peripheral Volume (Fast), Peripheral Volume (Slow)|Drug levels will be sampled only during the peri-operative time period (0 to 12 hours)|Vancomycin pharmacokinetics were assessed only in the Cefazolin 25 mg/kg body weight and Vancomycin arm|||L||95% Confidence Interval|Median
2656117|NCT01619982|Secondary|Cefazolin Pharmacokinetics|Measured as Elimination Clearance Inter-tissue Clearance (Fast) Inter-tissue Clearance(Slow)|Drug levels will be sampled only during the peri-operative time period (0 to 12 hours)|Cefazolin pharmacokinetics were assessed only in the Cefazolin 30 mg/kg Body Weight group|||L/min||95% Confidence Interval|Median
2656118|NCT01619982|Secondary|Cefazolin Pharmacokinetics|Cefazolin Pharmacokinetics was measured as Central Volume, Peripheral Volume (Fast), Peripheral Volume (Slow)|Drug levels will be sampled only during the peri-operative time period (0 to 12 hours)|Cefazolin pharmacokinetics were assessed only in the Cefazolin 30 mg/kg Body Weight group|||L||95% Confidence Interval|Median
2656121|NCT01619878|Secondary|Time to Fever Clearance (FCT)|Time from first dose to the first time the axillary body temperature decreased below and remained below 37.5° C for at least 48 hours.|Up to 7 days|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.|||hours||Standard Deviation|Mean
2656122|NCT01619878|Secondary|Time to Parasite Clearance (PCT)|Time from first dose until first total and continued disappearance of asexual parasite forms which remains at least a further 48 hours.|Up to 7 days|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.|||hours||Standard Deviation|Mean
2656123|NCT01619878|Secondary|Number of Participants With Parasitaemia at 72 Hours After Treatment Initiation Greater Than or Equal to 25 Percent of Count at Baseline|Number of participants with parasite density at 72 hours after treatment initiation greater than or equal to 25 percent of parasite density at baseline.|72 hours|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.|||participants|||Number
2656124|NCT01619878|Secondary|Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline|Number of participants with parasite density at 48 hours after treatment initiation greater than parasite density at baseline.|48 hours|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.|||participants|||Number
2656125|NCT01619878|Secondary|Percent Change of Parasite Count From Baseline at 24 Hours|Percent change of parasite count from baseline at 24 hours|baseline, 24 hours|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.|||Percent Change||Standard Deviation|Mean
2656126|NCT01619878|Secondary|Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42|Number of patients with clearance of asexual parasites at day 3, 7, 14, 28 and 42 after initiating study treatment.|Day 3, 7, 14, 28 and 42|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.|||participants|||Number
2656127|NCT01619878|Secondary|Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42|Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 14 and day 42, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.|Day 14 and 42|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.|||Number of participants|||Number
2656128|NCT01619878|Primary|Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate|Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 28, corrected for re-infection by Polymerase Chain Reaction (PCR) assay.|28 days|Full analysis set (FAS) – all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline.|||number of participants|||Number
2656129|NCT01619852|Secondary|Postoperative Pain|Postoperative pain within the first 24 hours. Area under the numeric rating scale for pain versus time curve during the first 24 hours after surgery (score * hr). Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve during the first 24 hours ( score * hr). The pain scores were collected upon arrival to recovery area, 30 minutes, 1 hour and every 6 hours up to 24 hours following the procedure. Minimum score is 60, Maximum score is 170. A higher value indicates more pain.|24 hours||||score on a scale||Inter-Quartile Range|Median
2656130|NCT01619852|Secondary|Opioid Consumption|The amount of opioid analgesics consumed was converted to an equivalent dose of intravenous morphine.|24 hours||||equivalent dose of intravenous morphine||Inter-Quartile Range|Median
2656131|NCT01619852|Secondary|Post-surgical Persistent Pain Using Validated Questionnaires (S-LANNS Questionnaire, McGill Questionnaire, Brief Pain Inventory) to Assess Pain Qualities in Accordance With IMMPACT Recommendations.|The development of chronic pain 3 months after surgery determined by the Leads Assessment of Neuropathic Symptoms and Signs (LANSS) scale, a valid 7-item tool for identifying patients whose pain is dominated by neuropathic mechanisms. Each item is a binary response (yes or no) to the presence of symptoms (5 items) or clinical signs (2 items), range 0-24 points. A score ≥ 12, neuropathic mechanisms are likely to be contributing to the patient's pain. A score < 12 is unlikely to be contributing. McGill questionnaire (Sensory domain) - 11 descriptors rated on an intensity scale as 0=none, 1=mild, 2=moderate, 3=severe. The higher the score, greater the pain (range 0-33). McGill questionnaire (Motivational-affective) 4 affect descriptors rated on an intensity scale as 0=none, 1=mild, 2=moderate, 3=severe.The higher the score the greater the pain (range 0-12) Brief pain inventory - pain severity (0, no pain, 10 excruciating pain); Greater the score; greater the pain (range 0-10).|3 months||||units on a scale||Inter-Quartile Range|Median
2656132|NCT01619852|Secondary|Quality of Recovery|Quality of recovery (QoR-40 instrument) is a 40-item questionnaire that provides a global score and sub-scores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Score range: 40 to 200. A score of 40 demonstrates poor recovery and a maximum score of 200 represents good recovery. The higher the score the better recovery after surgery.|24 hours post operative||||units on a scale||Inter-Quartile Range|Median
2656133|NCT01619852|Primary|Number of Participants With Chronic Persistent Pain 3 Months After Surgery as Determined by Character Severity (Yes/no).|The participants development of chronic persistent pain 3 months after surgery as determined by character severity (yes/no).|3 months||||participants|||Number
2656134|NCT01619800|Primary|Changed in Stress Test at 6 Months as Compared to Baseline|An Exercise or Dobumatime Stress Test to be performed to assess primary outcome measure.|baseline and 6 months|||||||
2656135|NCT01619787|Primary|Change in Energy Purchased as a Result of Subsidies|Change in total calories as a result of subsidies of 12.5% and 25%.|Study Completion|Data is reported for 199 participants. Out of 217 participants who started the study, 5 participants were lost to follow up, 1 participant shopped in the same store twice, 2 participants had conditions that would affect shopping, 2 participants did not report minority status and 8 male participants were excluded due to the small sample number.|||Total Calories Purchased||Standard Error|Least Squares Mean
2656160|NCT01618942|Primary|Pressure Pain Tolerance (PTO) With 0.01cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure||||kg/cm2||Standard Deviation|Mean
2656136|NCT01619787|Primary|Change in Energy Purchased as a Result of Taxes.|Change in total calories as a result of taxes of 12.5% and 25%.|Study Completion|Data is reported for 199 participants. Out of 217 participants who started the study, 5 participants were lost to follow up, 1 participant shopped in the same store twice, 2 participants had conditions that would affect shopping, 2 participants did not report minority status and 8 male participants were excluded due to the small sample number.|||Total Calories Purchased||Standard Error|Least Squares Mean
2656137|NCT01619774|Secondary|Progression-Free Survival (PFS)|Duration of response defined for subjects with a confirmed complete response (CR) or partial response (PR), as time from the first documented evidence of a CR or PR until the first documented disease progression or death due to any cause. Progression free survival (PFS) estimated and summarized using the method of Kaplan and Meier.|Evaluation every 8 weeks (2 cycles) up to 12 months|Three of the 23 participants were not evaluable for response therefore not included PFS analysis.|||weeks||95% Confidence Interval|Median
2656138|NCT01619774|Primary|Number of Participants by Response|Clinical responses evaluated using RECIST 1.1 criteria after every 2 cycles (8 weeks). Complete Response (CR): Disappearance all lesions; pathological lymph nodes reduction in short axis to <10 mm. Partial Response (PR): >30% decrease in sum diameters of lesions, reference baseline sum diameters. Progressive Disease (PD): >20% increase in sum diameters of lesions, reference smallest sum on study (includes baseline sum if smallest on study); relative increase of 20%, sum must also demonstrate absolute increase of >5 mm; appearance of 1 or > new lesions considered progression). Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD, reference smallest sum diameters while on study.|Evaluation every 8 weeks (2 cycles) up to 12 months||||participants|||Number
2656139|NCT01619774|Primary|Overall Response Rate (ORR)|"Overall response rate defined as percentage of subjects with a confirmed complete response (CR) or a partial response (PR) at any time as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Clinical responses will be evaluated using RECIST 1.1 criteria after every 2 cycles (8 weeks).~Complete Response (CR): Disappearance all lesions; pathological lymph nodes reduction in short axis to <10 mm. Partial Response (PR): >30% decrease in sum diameters of lesions, reference baseline sum diameters. Progressive Disease (PD): >20% increase in sum diameters of lesions, reference smallest sum on study (includes baseline sum if smallest on study); relative increase of 20%, sum must also demonstrate absolute increase of >5 mm; appearance of 1 or > new lesions considered progression). Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD, reference smallest sum diameters while on study."|Evaluation every 8 weeks (2 cycles) up to 12 months|Three of the 23 participants were not evaluable for response.|||Percentage of Participants|||Number
2656140|NCT01619579|Primary|Symptom Severity (SS) Score After 4 Weeks Treatment|"Symptom Severity (SS) Score Range is 0 to 12. 0 = Lowest pain score (Best Outcome). 12 = Highest pain score (Worst Outcome).~The SS scale identifies the level of severity sum of 4 categories (Fatigue, Waking Unrefreshed, Cognitive Symptoms, Somatic Symptoms) over the past week, using this scale:~0 = no problem~slight or mild~moderate~severe: continuous, life-disturbing"|4 Weeks|Enrolled population was diagnosed with FMS according to the 2010 ACR diagnostic criteria. Three participants withdrew from the study for personal reasons and their post-therapy data were not obtained.|||units on a scale||Full Range|Mean
2656141|NCT01619579|Primary|Tender Point Count (TPC) After 4 Weeks Treatment|"Tender Point Count (TPC) Score Range is 0 to 18. 0 = Lowest pain score (Best Outcome). 18 = Highest pain score (Worst Outcome). The criteria required confirming tenderness used 4kg of pressure applied to a total of 18 specified tender point sites.~Fibromyalgia is diagnosed with a minimum tenderness count in 11 of 18 points."|4 Weeks|Enrolled population was diagnosed with FMS according to the 2010 ACR diagnostic criteria. Three participants withdrew from the study for personal reasons and their post-therapy data were not obtained.|||units on a scale||Full Range|Mean
2656142|NCT01619579|Primary|Widespread Pain Index (WPI) Score After 4 Weeks Treatment|Widespread Pain Index (WPI) Score Range is 0 to 19 points. 0 = Lowest pain score (Best Outcome). 19 = Highest pain score (Worst Outcome). Widespread pain was defined as pain occurring in at least 2 contralateral body quadrants, in addition to the axial skeleton for at least 3 consecutive months.|4 Weeks|Enrolled population was diagnosed with FMS according to the 2010 ACR diagnostic criteria. Three participants withdrew from the study for personal reasons and their post-therapy data were not obtained.|||units on a scale||Full Range|Mean
2656143|NCT01619423|Primary|Number of Patients With Neuropathy Grade 2 or Higher (According to the Oxaliplatin Specific Sanofi Scale (OSSS) Criteria Related Paraesthesia/Dysaesthesia)|Percentage of patients, over cycle 1 to 8, with neuropathy grade 2 or higher (according to the Oxaliplatin Specific Sanofi Scale (OSSS) criteria related paraesthesiae/dysaesthesiae)|Every second week during cycle 1-8, for up to 16 weeks|Full analysis set|||Participants|||Count of Participants
2656144|NCT01619410|Secondary|The Type of of Staphylococcus Aureus Present at the Diagnosis Will be Compared to the Type of Staphylococcus Aureus Present After Treatment|The genotype of Staphylococcus aureus which is found to be the cause of the skin infection will be be compared to the genotype of Staphylococcus aureus present after treatment. Comparisons will will be made between the linezolid and clindamycin treatment groups.|40 days after completion of treatment|No data available due to samples being lost as a result of equipment issues.||||||
2656145|NCT01619410|Secondary|Number of Participants With Clinical Response of Skin Infections to Treatment -- 40 Days|The efficacy of linezolid versus clindamycin in the treatment of skin infections will be measured using treatment outcomes of cure, treatment failure, or relapse.|40 days after completion of treatment||||Participants|||Count of Participants
2656146|NCT01619410|Secondary|Number of Participants With Clinical Response of Skin Infections to Treatment -- 7 Days|The efficacy of linezolid versus clindamycin in the treatment of skin infections will be measured using treatment outcomes of cure, treatment failure, or relapse.|7 days after completion of treatment||||Participants|||Count of Participants
2656147|NCT01619410|Primary|Number of Participants With Presence of Staphylococcus Aureus After Treatment With Linezolid Versus Clindamycin|Asymptomatic carriage of Staphylococcus aureus at the 40-day visit will be compared in the patients assigned to receive linezolid to the patients assigned to receive clindamycin.|40 days after completion of treatment|Only subjects returning for the 40-day outcome measurement were included in this analysis|||Participants|||Count of Participants
2656161|NCT01618942|Primary|Pressure Pain Tolerance (PTO) With 0.1cm2 Probe|The value was calculated as a avarage value of different measurement sites|1 hour after the procedure||||kg/cm2||Standard Deviation|Mean
2656148|NCT01619085|Primary|Incidence of Adverse Events (AE)|This is the measure for percentage of patients with adverse events observed during the trial. The incidence of AEs (% of patients) over the course of the trial, including the incidence of serious AEs, AEs leading to discontinuation, and fatal AEs are presented.|From first drug administration until treatment period, in total up to 56.3 months.|Treated set (TS): The data set consisted of all patients who were dispensed trial medication and were documented to have taken at least one dose.|||Percentage of patients (%)|||Number
2656149|NCT01619059|Secondary|Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|From Baseline to Week 24|All randomized participants who received study medication and were not missing baseline and Week 24 (LOCF) values|||Percent of participants||95% Confidence Interval|Number
2656150|NCT01619059|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose at Week 24|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing FPG values at baseline and Week 24|||mg/dL||Standard Error|Mean
2656151|NCT01619059|Secondary|Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing PPG values at baseline and Week 24|||mg/dL||Standard Error|Mean
2656152|NCT01619059|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24|HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.|From Baseline to Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24|||Percent of glycosylated haemoglobin||Standard Error|Mean
2656153|NCT01618968|Primary|Dose-Normalized Cmax for MTX|Dose-normalized maximum observed concentration (Cmax) for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.|||ng/mL/mg||Standard Deviation|Mean
2656154|NCT01618968|Primary|Dose-Normalized AUC[0-24] for MTX|Dose-normalized area under the curve from time zero to 24 hours (AUC[0-24]/Dose) for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.|||ng*hr/mL/mg||Standard Deviation|Mean
2656155|NCT01618968|Primary|Dose-Normalized AUC[0-Inf] for MTX|Dose-normalized area under the curve from time zero to infinity (AUC[0-inf]/Dose) for each treatment|24 Hour period|The Population was defined as all randomized subjects who received at least 1 dose of study drug and who had at least 1 valid post-dose plasma concentration value.|||ng*hr/mL/mg||Standard Deviation|Mean
2656156|NCT01618955|Secondary|Tolerance of Vibex MTX Device (Injection Site Pain Severity as Reported by Patient on VAS Scale - 0 mm = no Pain to 100 mm = Very Severe Pain)|"A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device.~Visual Analog Scale assessment of injection site pain was reported by patients on 100 mm line immediately after an injection and at 24 hours after injection."|24 hours|The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For continuous data, summary statistics (N, mean, standard deviation, median, minimum, and maximum) were provided.|||mm||Standard Deviation|Mean
2656157|NCT01618955|Secondary|Safety of Vibex MTX Device|"A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device~Injection site assessments were done 0.25 hour, 1 hour, 6 hours and 24 hours after an injection and reported as the following:~Erythema - 0 = None~Erythema - 1 = Very slight, barely perceptible~Erythema - 2 = Obvious, but well defined~Erythema - 3 = Moderate to severe~Erythema - 4 = Severe"|24 hours|The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For categorical data, counts and percentages are presented.|||Percentage of Participants|||Number
2656158|NCT01618955|Secondary|Reliability and Robustness of Vibex MTX Device as Well as Effectiveness of Patient Education Tools|"A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device~Ease of use Questionnaire was completed by patients immediately after self-injection~Training confirmation questionnaire was completed by patients after the training and then reviewed with PI or site coordinator"|24 hours|The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For categorical data, percentages are presented.|||Percentage of Participants|||Number
2656159|NCT01618955|Primary|Safe Usability of the VIBEX MTX Device for Subcutaneous (SC) Self-injection With Methotrexate (MTX) in Adult Patients With Rheumatoid Arthritis (RA) as Demonstrated by Successful Self-Injection|"A total of 101 patients were included in the Safety Population, which consisted of all patients who received standardized training by site personnel and review of written instructions. And then self-administered study drug using Vibex MTX device.~The Assessment of Essential Tasks Questionnaire was completed by site personnel documenting a patient's performance of essential self-injection steps, including the following:~SC self-injection was administered by the patient~SC self-injection was intentional~self-injection was administered in an appropriate location on the abdomen~patient removed cap marked 1~patient removed cap marked 2~patient held device at injection site for 3 seconds~patient confirmed that the window was obstructed"|24 hours|The safety population consisted of all subjects who received study drug and administered a successful or unsuccessful self-injection. For categorical data, percentages are presented.|||Percentage of Participants|||Number
2656168|NCT01618916|Secondary|Percent Change From Baseline to Days 43, 57, and 127 in LDL-C|Percent change from baseline in LDL-C was calculated as Least Squares (LS) mean using mixed effect model repeated measures (MMRM) analysis adjusted for baseline measurement, treatment, day after dosing, and treatment by day interaction.|Baseline, Day 43, Day 57, and Day 127|Randomized participants who received at least 1 dose of study drug (LY3015014 or placebo) and had a baseline and at least 1 postbaseline measurement for LDL-C.|||percentage of change||95% Confidence Interval|Least Squares Mean
2656169|NCT01618916|Secondary|PK: Time of Maximum Concentration (Tmax) of LY3015014|The tmax following the first dose and last dose of LY3015014 is reported.|First Dose: Predose (Day 1) up to Week 4 postdose and Last Dose: predose (Day 29) up to Week 14 postdose|All randomized participants who received at least 1 dose of LY3015014 and had evaluable tmax data.|||days||Full Range|Median
2656170|NCT01618916|Secondary|PK: Area Under the Concentration Curve of LY3015014 During 1 Dosing Interval (AUC[0-tau])|The AUC(0-tau) following the first dose and last dose of LY3015014 is reported.|First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose|All randomized participants who received at least 1 dose of LY3015014 and had evaluable AUC(0-tau) data.|||micrograms*hours/milliliter (µg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2656171|NCT01618916|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3015014|The Cmax following the first dose and last dose of LY3015014 is reported.|First Dose (Day 1) and Last Dose (Day 29): Predose, 4 Hours and 24 Hours Postdose|All randomized participants who received at least 1 dose of LY3015014 and had evaluable Cmax data.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2656172|NCT01618916|Primary|Number of Participants With 1 or More Drug Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAEs)|TEAEs were defined as SAEs and other non-serious AEs that occurred or worsened after study treatment. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events section of this report.|Baseline through study completion (up to Day 127)|All enrolled participants who received at least 1 dose of study drug (LY3015014 or placebo).|||Participants|||Count of Participants
2656173|NCT01618864|Secondary|Reduction in Rosacea by the Study Investigator Using a Validated Scale|Data reported as percentage of participants showing improvement in rosacea scale: 4 point scale for presence of rosacea features from 0 (absent) to 3 (severe) for: flushing, nontransient erythema, papules and pustules and telangiectasia.|4, 8 weeks|Not all subjects had rosacea. 11 subjects evaluated at baseline and 4 weeks; 9 subjects evaluated at 8 weeks, since 2 subjects lost to follow-up.|||percentage of participants|||Number
2656174|NCT01618864|Secondary|Subject Improvement Using the Global Aesthetic Improvement (GAI) Scale|Data reported as percentage of participants showing improvement in overall score as assessed by subject. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement) provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage. Analogous to Outcome Measure 1.|4, 8 weeks||||percentage of participants|||Number
2656175|NCT01618864|Primary|Improvement in Investigator Assessment of Overall Global Aesthetic Improvement Scale (GAI)|Data reported as percentage of participants showing improvement in overall score as assessed by investigator. 5 point scale of 0 (no difference) to 4 (Significantly marked improvement)provided for overall improvement in skin texture, roughness, skin color (even/blotchy), erythema and photo-damage.|4, 8 weeks||||percentage of participants|||Number
2656176|NCT01618838|Secondary|Progression-free Survival|Progression-free survival will be defined as the time in months from study entry until progression or death. Patients who are alive and free from progression on the date of closing follow-up will be censored on that date. Data table reports the number of participants who were alive without progression at the end of the study.|Planned for 7 years, collected up to 23 months||||Participants|||Count of Participants
2656177|NCT01618838|Secondary|Proportion of Patients With Rectal Bleeding.||Planned for 7 years, collected up to 23 months|No patients had outcome before the trial was terminated.|||Participants|||Count of Participants
2656178|NCT01618838|Primary|Proportion of Patients With Endoscopically Detectable-telangiectasia (VRS Grade 1 or Higher).|"Telangiectasia is the primary outcome since it is a measure of tissue fibrosis (primary source of proctitis) and is a well-defined and measurable outcome.~No patients had outcome before the trial was terminated."|Planned for 7 years, collected up to 23 months||||Participants|||Count of Participants
2656179|NCT01618708|Secondary|Percentage of WOMAC A1 Responder Over 26 Weeks|WOMAC A1 responder rate defined as ≥2 point improvement on 11-point NRS Scale, generalized estimating equations modeling was used for the analysis of WOMAC A1 responders.|From Baseline to Week 26|ITT population.|||Percentage of participants|||Number
2656180|NCT01618708|Secondary|Change From Baseline in Patient Global Self-Assessment (PTGA) Score Over 26 Weeks|PTGA (self-assessment of target hip osteoarthritis condition) was measured using the 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents very well condition and higher score represents very poor condition.|From baseline to Week 26|ITT population.|||units on a scale||Standard Error|Least Squares Mean
2656181|NCT01618708|Secondary|Change From Baseline in WOMAC A Score Over 26 Weeks|WOMAC NRS 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) was measured on 11-point NRS ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.|From Baseline to Week 26|ITT population.|||units on a scale||Standard Error|Least Squares Mean
2656182|NCT01618708|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks|WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.|From baseline to Week 26|ITT population.|||units on a scale||Standard Error|Least Squares Mean
2656285|NCT01617655|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2656183|NCT01618669|Secondary|Number of Participants With Adverse Events Within 24 Hours After Administration of Regadenoson|"An adverse event is considered serious if, in the view of either the investigator or sponsor, it results in any of the following outcomes:~Results in death,~Is life threatening,~Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions,~Results in congenital anomaly, or birth defect,~Requires inpatient hospitalization or leads to prolongation of hospitalization~Other medically important events.~Relationship to study drug was assessed by the investigator."|Up to 24 hours after study drug administration for each stress MPI (Day 1 and Day 2-15)|Safety Analysis Set.|||participants|||Number
2656184|NCT01618669|Secondary|Percentage of Cardiac Segments Obscured by Subdiaphragmatic Activity|The number of cardiac segments obscured by the sub-diaphragmatic activity by group by stress SPECT MPI scan and by reader is reported.|Day 1 (stress MPI 1) and Day - 15 (stress MPI 2)|Full Analysis Set|||percentage of segments|||Number
2656185|NCT01618669|Secondary|Percentage of Scans With Subdiaphragmatic Interference|Each reader assessed the sub-diaphragmatic radiotracer interference with cardiac image quality using a 4-point scale of 0 = none, 1 = slight, 2 = moderate or 3 = severe for each stress SPECT MPI. The median rating across the 3 readers was used to summarize the percentage of scans with interference.|Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2)|Full Analysis Set|||percentage of stress MPI scans|||Number
2656186|NCT01618669|Secondary|Target to Background Radiotracer Uptake Ratios From the First and Second Stress Scans|Image quality was assessed through radiotracer uptake in the heart (target organ) compared to liver, gut and combined liver plus gut (background interference).|Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full analysis set participants who have planar images available for each scan|||ratio||Standard Deviation|Mean
2656187|NCT01618669|Secondary|Overall Assessment of Image Quality|The image quality for each scan was rated by each independent reader as 1 = Poor, 2 = Fair, 3 = Good, 4 = Excellent. Based on the median rating of overall image quality across the three readers, the number of participants with each rating is reported for each scan.|Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full Analysis Set|||participants|||Number
2656188|NCT01618669|Secondary|Participants With Less, the Same, or More Reversible Perfusion Defects Shown by the First Stress Scan When Compared to the Second Stress Scan|Each reader evaluated the initial stress SPECT MPI scan compared to the participant's second stress SPECT MPI scan (blinded at time of the evaluation) for whether there was Less (-1), the Same (0) or More (1) reversible perfusion defects. The median assessment of the 3 blinded readers was used to summarize the number of participants in each category.|Day 1 (stress MPI 1) and Day 2-15 (stress MPI 2)|Full Analysis Set|||participants|||Number
2656189|NCT01618669|Secondary|Proportion of Participants With Agreement in the Summed Difference Score (SDS) Between First and Second Stress Scans|"The 17-segment model for standardized myocardial segmentation was used to analyze MPI scans. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/ uptake~2: moderately reduced contrast/uptake~3: severely reduced contrast/uptake~4: absent contrast/uptake.~SSS was calculated as the sum of the stress scores across the 17 segments and the Summed Rest Score (SRS) was calculated as the sum of the rest scores across the 17 segments. The Summed Difference Score (SDS) is the difference in the SSS and SRS (SSS - SRS).~The mean value (rounded to the nearest integer) across the 3 readers was computed and the SDS was categorized into 3 categorical variables based on the score: 0 to 6, 7 to 13 and ≥ 14. The proportion of participants with agreement in respect to these categories between the two stress scans was calculated."|Day 1 (rest MPI and stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full Analysis Set|||participants|||Number
2656190|NCT01618669|Secondary|Proportion of Participants With Agreement in the Summed Stress Score (SSS) Between First and Second Stress Scans|"The 17-segment model for standardized myocardial segmentation was used to analyze MPI scans. Each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake.~The Summed Stress Score (SSS) was calculated as the sum of the stress scores across the 17 segments. The mean value (rounded to the nearest integer) across the 3 readers was computed and the SSS was categorized into 4 group categorical variables based on the score: 0 to 3, 4 to 7, 8 to 11, and ≥ 12. The proportion of participants with agreement in respect to these categories between the two stress scans was calculated."|Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full Analysis Set|||proportion of participants|||Number
2656191|NCT01618669|Secondary|Proportion of Participants With Agreement in the Assessment of Reversible Defects in 3 Categories of Ischemia Between First and Second Stress Scans|The number of segments with reversible defects was assessed by each of the 3 blinded independent expert readers. Based on the median count of the number of reversible defects across the 3 readers, categorized as 0 to 1, 2 to 4, or ≥ 5 reversible segments, the proportion of participants with agreement in the three ischemia categories between the first and second stress scans was to be calculated. In the reported data, these proportions only include the 0-1 and 2-4 categories; the ≥ 5 category was not included because there were no participants in this category for the Regadenoson Alone group for the initial stress MPI.|Day 1 (stress MPI 1) and Day 2 - 15 (stress MPI 2)|Full Analysis Set|||proportion of participants||95% Confidence Interval|Number
2656192|NCT01618669|Secondary|Proportion of Participants With Agreement in the Assessment of Absence or Presence of Ischemia Between First and Second Stress Scans|The number of segments with reversible defects was assessed by each of the 3 blinded independent expert readers. Based on the median count of the number of reversible defects across the 3 readers, categorized as absence (0 to 1 reversible segments) or presence (≥ 2 reversible defects) of ischemia, the proportion of participants with agreement in the presence and absence of ischemia between the first and second stress scans was calculated.|Day 1 (stress MPI 1) and Day 2 -15 (stress MPI 2)|Full Analysis Set|||proportion of participants||95% Confidence Interval|Number
2656262|NCT01617681|Secondary|Patients Achieving <90th Percentile for Age, Gender and Height at Week 6 Endpoint in Both MSBP and MDBP|Patient's blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) Week 6|Week 6|Full analysis set (FAS) included all randomized patient except for 1 patient that guardian did not sign informed consent|||participants|||Number
2656193|NCT01618669|Secondary|Percentage of Participants With Treatment-emergent Clinically Significant Cardiac Events|"A clinically significant cardiac event is defined as:~Any of the following events found on the Holter electrocardiogram (ECG)/12-Lead ECG within 1 hour after regadenoson administration:~ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, ventricular flutter),~ST-T depression (> 2 mm),~ST-T elevation (≥1 mm),~Atrioventricular (AV) block (2:1 AV block, AV Mobitz I, AV Mobitz II, complete heart block)~sinus arrest > 3 seconds in duration~Or~a treatment-emergent adverse event (TEAE) per the Medical Dictionary for Regulatory Activities (MedDRA) Standardised MedDRA Queries (SMQ) (Narrow Scope) for myocardial infarction~Or~a TEAE preferred term of angina unstable within 24 hours of regadenoson administration."|Within 1 hour for ECG events and up to 24 hours for adverse events after administration of regadenoson|Safety analysis set (all randomized participants who received at least 1 dose of regadenoson study drug)|||percentage of participants|||Number
2656194|NCT01618669|Primary|Proportion of Participants With Majority Reader Self-agreement in Ischemia Assessment Between First and Second Stress Scans|"SPECT scans were reviewed in a blinded fashion by 3 independent expert readers using the 17-segment model for standardized myocardial segmentation. At rest and stress, each segment was scored on a 0 (normal) to 4 (absent contrast/radiotracer uptake) scale by each of the 3 blinded readers according to the amount of contrast or radiotracer the myocardium in the segment absorbed. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect.~The number of segments with reversible defects was categorized as absence (0 - 1 reversible segments) or presence (≥ 2 defects reversible segments) of ischemia.~Each reader was defined as having self-agreement based upon identical categorization of a given participant as absent or present for ischemia for both the initial and second stress visits.~Majority agreement is if at least 2 out of the 3 blinded readers demonstrated self-agreement for a given participant."|Day 1 (rest scan and first stress scan) and Day 2 -15 (second stress scan)|Full Analysis Set|||proportion of participants||95% Confidence Interval|Number
2656195|NCT01618422|Primary|Number of Participants Suffering From Treatment Failure/ Relapse (Unfavourable Outcome) Among Rifampicin Resistant Group.|"Cure (Completed for 8 months or more of therapy and culture converted in the last month of treatment, and on at least one previous occasion; for multidrug resistant TB (MDR-TB) switched to definitive second line therapy per protocol in the DOTS-plus group, sustained culture conversion for at least 6 months after initiation of second line therapy and no evidence of culture reversion up to the scheduled follow-up point); Treatment failure: not culture converted at 5 months or later; Defaulted: having interrupted treatment for 2 consecutive months or more; Transfer out: having been transferred to another recording and reporting unit and for whom the treatment outcome is not known; Death: a patient who died for any reason during the course of treatment Diagnosis revised: diagnosis revised to non-tuberculous mycobacterial infection or colonisation.~Withdrawal: physician-initiated withdrawal for adverse effects, protocol violation or patient's decision to withdraw."|18-month||||participants|||Number
2656196|NCT01618344|Primary|Feasibility and Acceptability of Using a Smart-phone Medication Reminder Application to Promote Adherence to Oral Medications by AYA With Cancer.|Feasibility was assessed through participants' application usage and responses to self-reported questions about their use of the application. Acceptability was assessed through participants' perceived ease of use and perceived usefulness of the application.|ongoing study weeks 5-12||||Participants|||Count of Participants
2656197|NCT01618305|Secondary|Proportion of Women With HIV-1 Drug Resistance Mutations at Screening, 2-4 Weeks Postpartum in Women Who Stopped Antiretroviral Therapy, and at the Time of Inadequate Virologic Response Using Standard and Ultrasensitive Methods.|"Consensus sequencing was performed on a sample from screening. Women were evaluated for integrase and reverse transcriptase resistance mutations separately.~Additionally, consensus sequencing was performed among women who had an inadequate virologic response (defined in the protocol) on a sample taken at that time of inadequate virologic response.~Genotypic resistance among women who stopped antiretroviral therapy was not assessed. Because World Health Organization guidelines have been updated to indicate all people living with HIV should remain on antiretroviral therapy, even postpartum women, no women stopped antiretroviral therapy after delivery. Therefore, this aspect of the outcome measure is no longer relevant and was not assessed."|Measured at screening and at the time of inadequate virologic response (from Week 2 antepartum through participants' last study visit 24 weeks after delivery).|Women were excluded if they had indeterminate or unknown resistance results for that class of antiretroviral study drug.|||Proportion|||Number
2656198|NCT01618305|Secondary|Proportion of HIV-infected Infants With Genotypic Resistance to Study Drugs|Genotypic resistance to each class of study drug (reverse transcriptase inhibitors and integrase inhibitors) was assessed separately among HIV infected infants.|Measured on or after confirmation of HIV-infection up to the infants' last study visit at Week 24|One infant in the efavirenz arm did not have a specimen collected with sufficient viral load to perform consensus sequencing. All other infected infants had genotypic resistance results for both classes of study drug.|||Proportion|||Number
2656199|NCT01618305|Secondary|Infant HIV Infection Status (Per International Maternal Pediatric Adolescent AIDS Clinical Trials Group [IMPAACT] Definitions)|Infants were considered infected if they had both a positive HIV nucleic acid test and a subsequent confirmatory test on a different sample. Uninfected infants were those that had no positive test results and negative test results obtained at two or more of the following visits: Week 6, Week 16, and/or Week 24 postpartum.|Measured from birth through infants' last study visit at Week 24|Infants who had no positive test result, but did not have negative results at at least two of Week 6, 16, and/or 24 postpartum visits were not eligible for this analysis. All infants who had at least one positive test also had a positive confirmation test, and are included in this outcome.|||Participants|||Count of Participants
2656200|NCT01618305|Secondary|Proportion of Deliveries With an Extremely Low Birth Weight (<1,500 Grams).|The unit of analysis was the mother-infant pair or set; in the case of multiple gestation, the worst outcome was considered in analysis (e.g. if two twins were delivered to one mother, one at 2,000 grams and one at 1,000 grams, this mother-infant set would count as one instance of extremely low birth weight in analysis because at least one of the infants had the outcome).|Measured within 72 hours after delivery|All women who delivered at least one live-birth infant on-study were included in this analysis. Although 393 live-born infants were delivered, there were three sets of twins. Therefore, 390 mother-infant pairs were included in this analysis.|||Proportion|||Number
2656201|NCT01618305|Secondary|Proportion of Deliveries With a Low Birth Weight (Less Than 2,500 Grams)|The unit of analysis was the mother-infant pair or set; in the case of multiple gestation, the worst outcome was considered in analysis (e.g. if two twins were delivered to one mother, one at 2,000 grams and one at 3,000 grams, this mother-infant set would count as one instance of low birth weight in analysis because at least one of the infants had the outcome).|Measured within 72 hours after delivery|All women who delivered at least one live-birth infant on-study were included in this analysis. Although 393 live-born infants were delivered, there were three sets of twins. Therefore, 390 mother-infant pairs were included in this analysis.|||Proportion|||Number
2656202|NCT01618305|Secondary|Proportion of Deliveries That Were Extremely Premature (Less Than 34 Weeks Gestation).|"The unit of analysis for this outcome measure was the mother-infant set. A mother-infant set was counted as having an extremely premature delivery if any infant in the mother-infant set was delivered prior to 34 weeks gestation (i.e. in the case of twins, if either of the twins was delivered prior to 34 weeks gestation then this set would count as one extremely premature delivery outcome).~Only women who enrolled prior to 34 weeks gestation were included in this analysis. Those that enrolled from 34 to less than 37 weeks gestation were excluded because they were already past the gestational age where this outcome could have occurred at entry."|At delivery (within 72 hours).|There were 393 live-birth infants on study. There were three sets of twins, leaving 390 mother-infant sets that delivered at least one live birth on study. Among these, five were missing gestational age at delivery (three EFV and two RAL sets) and 45 were enrolled from 34 to less than 37 weeks gestation and excluded, leaving 340 evaluable sets.|||Proportion|||Number
2656203|NCT01618305|Secondary|Proportion of Deliveries That Were Premature (Less Than 37 Weeks Gestation)|"The unit of analysis for this outcome measure was the mother-infant set. A mother-infant set was counted as having a premature delivery if any infant in the mother-infant set was delivered prior to 37 weeks gestation (i.e. in the case of twins, if either of the twins was delivered prior to 37 weeks gestation then this set would count as one premature delivery outcome).~All mother-infant sets that delivered at least one live birth on study were eligible for this outcome."|Measured at delivery (within 72 hours).|There were 393 live-birth infants on study. There were three sets of twins, leaving 390 mother-infant sets that delivered at least one live birth on study. Five sets (three EFV and two RAL) did not have gestational age at delivery recorded and were excluded, leaving 385 sets included in this outcome.|||Proportion|||Number
2656204|NCT01618305|Secondary|Proportion of Deliveries That Had an Outcome of a Stillbirth/Fetal Demise.|The unit of analysis was the mother-infant set. All sets where the woman received at least one dose of study treatment and remained on study through delivery were eligible. In the case of twins, the worst outcome (i.e. a stillbirth) was used.|Measured at delivery (approximately 36 to 40 weeks gestation)|Fourteen women (8 in Arm A and 6 in Arm B) were off-study prior to delivery (including the 5 women in Arm A who never initiated study treatment).|||Proportion|||Number
2656205|NCT01618305|Secondary|Infectivity of Plasma|The goal of this outcome measure was to address an objective relevant to protease inhibitors, one of which was originally included as a third arm in the Version 2.0 of the study. This outcome measure was included to assess how the infectivity of plasma changed over time among women receiving protease inhibitors, and whether this differed from other classes of antiretroviral drugs. However, the lopinavir/ritonavir arm was later dropped in Version 3.0, and only Version 2.0 women who received efavirenz or raltegravir were included in the study analyses. Therefore, because no women included in the study analyses received lopinavir/ritonavir, this outcome measure was not analyzed.|Measured on or after delivery up to participants' last postpartum study visit (approximately 26 weeks after delivery)|Because the study arm that was associated with this outcome measure was dropped, no women were assessed for this outcome.||||||
2656206|NCT01618305|Secondary|Proportion of Women With HIV-1 RNA Vaginal Viral Load Less Than 1200 Copies/mL at Weeks 4 and 6 From Treatment Initiation|"The Week 4 and 6 participant viral loads were the viral load results obtained closest to (within four days of) the target date for that visit from initiation of treatment (for Week 4, day 24-32 after first dose; for Week 6, day 38-46 after first dose).~Vaginal swabs produce much less testable sample volume than blood plasma draws. Each vaginal swab specimen had to be diluted, and this dilution factor raised the lower limit of quantification (LLQ). The most commonly observed LLQs were 300 and 1200. For consistency, the higher LLQ was considered the threshold for this outcome measure."|Measured at Weeks 4 and 6 from first dose of randomized treatment, prior to delivery|Participants were included if they had a valid RNA results at Week 4 and/or Week 6, and had not delivered prior to obtaining the viral load measurement for that week.|||Proportion|||Number
2656207|NCT01618305|Secondary|Proportion of Women With HIV-1 RNA Plasma Viral Load Less Than 200 Copies/mL at Weeks 4 and 6 From Treatment Initiation|The Week 4 and 6 participant viral loads were the viral load results obtained closest to (within four days of) the target date for that visit from initiation of treatment (for Week 4, day 24-32 after first dose; for Week 6, day 38-46 after first dose).|Measured at Weeks 4 and 6 from first dose of randomized treatment, prior to delivery|Women were evaluable for Week 4 and/or Week 6 if they did not deliver prior to that study week and had at least one HIV-1 RNA plasma viral load obtained within 4 days of the target date from treatment initiation|||Proportion|||Number
2656208|NCT01618305|Secondary|Log10 Change in Viral Load From Entry to Each Time Point Prior to Delivery|"Change in viral load from entry (or screening, if there was no entry viral load) to each study week prior to delivery, calculated on the log10 scale as log10(week X RNA) - log10(baseline RNA).~For this analysis, HIV-1 RNA values that were censored below the lower limit of quantification (LLQ) were imputed to be equal to the LLQ - 1."|Measured at antepartum Weeks 1, 2, 4, 6, 8, 10, 12, 14, and 16.|Women were included in each week below if they had not delivered prior to that week and had an RNA viral load result for that antepartum visit.|||Log10 copies/mL||Inter-Quartile Range|Median
2656219|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset ≥3 Months|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was ≥3 months prior to treatment.|Baseline, Month 6|All enrolled patients with macular edema onset ≥3 months|||Letters||Standard Deviation|Mean
2656209|NCT01618305|Secondary|Proportion of Women With 1) Successful Viral Load (Plasma HIV-1 RNA VL) Decrease From Entry to Week 2 and VL Less Than 1,000 Copies/ml at All Time Points After 4 Weeks on Study Drugs, Until Delivery; and 2) Who Remain on the Assigned Study Regimen|A successful viral load decrease was defined as follows: for women having HIV-1 RNA viral load greater than or equal to 10,000 copies/mL at entry, a viral load <200 copies/mL; for women with VL less than 10,000 copies/mL at entry, a Log10 viral load decrease of at least 2.0 from entry.|Measured from entry through delivery (approximately 36 to 40 weeks gestation).|Women were evaluable for this outcome measure if they had (1) a valid viral load result at Week 2 (day 11-17 after initiation of study drug), (2) initiated study drug, and (3) delivered on- study; evaluable women who delivered after 28 days on study drug additionally had (4) at least one viral load result after 28 days on study drug.|||Proportion|||Number
2656210|NCT01618305|Secondary|Proportion of Women Who Achieved HIV-1 RNA Virologic Suppression Below the Lower Limit of Quantification of the Assay at Delivery|"A successful outcome was defined as maternal HIV-1 RNA plasma viral load less than the lower limit of quantification (LLQ) for the testing assay, which could vary. Most (99%) women had their viral load measured using an assay with LLQ equal to 40 or 20 copies/mL.~If the viral load at delivery was missing, the last observed viral load within 21 days prior to the delivery date was considered."|Measured at participants' delivery visit (or last visit within three weeks prior to delivery)|Eligible women were those that had a plasma HIV-1 RNA viral load at (or within 21 days prior to) delivery. Evaluable women were those with HIV-1 RNA viral load >200 copies/mL at baseline, and results from genotypic testing performed on a sample taken at screening indicating no genotypic resistance to any study drug.|||Proportion|||Number
2656211|NCT01618305|Primary|Proportion of Infants Who Experienced at Least One Adverse Event of Greater Than or Equal to Grade 3.|All infants who were live births on study were eligible for this analysis. Adverse event grades were defined based on the DAIDS toxicity table.|Measured from birth through infants' last study visit, approximately 24 weeks after delivery|All live born infants were included in this analysis.|||Proportion|||Number
2656212|NCT01618305|Primary|Proportion of Women Who Experienced at Least One New Adverse Event of Greater Than or Equal to Grade 3 as Defined in the Division of AIDS (DAIDS) Toxicity Table|"New adverse events were those with an onset date on or after randomization. Adverse events present at baseline would only be considered New if they increased in grade on or after randomization.~All women who received at least one dose of study drug were eligible for this analysis."|Measured from entry through participants' last study visit, approximately 24 weeks after delivery|Five women (all in Arm A) never initiated their assigned study treatment and were not included in this analysis.|||Propotion|||Number
2656213|NCT01618305|Primary|Proportion of Participants Who Discontinued Randomized Study Drug Prior to Labor and Delivery.|Only women who initiated (i.e. received at least one dose of) their randomized treatment were eligible for this outcome measure. Women were considered to have discontinued study drug if they stopped receiving efavirenz or raltegravir (whichever was assigned) prior to labor and delivery for any reason, including loss to follow-up.|Measured from entry through participants' delivery visit (approximately 36 to 40 weeks gestation)|Five women (all in Arm A) never initiated treatment, and thus were not included in this outcome measure.|||Proportion|||Number
2656214|NCT01618305|Primary|Proportion of Women With Plasma HIV-1 RNA Viral Load Less Than 200 Copies/mL at Delivery|If there was no viral load measurement at the delivery visit, the last viral load within three weeks prior to delivery was considered.|Measured at participants' delivery visit (or last visit within three weeks prior to delivery)|Eligible women were those with plasma HIV-1 RNA viral load at (or within three weeks prior to) delivery. Evaluable women had HIV-1 RNA plasma viral load greater than or equal to 200 at entry (i.e. did not already have the outcome) and had resistance testing results (on a sample taken at screening) showing no genotypic resistance to any study drug.|||Proportion|||Number
2656215|NCT01618266|Secondary|Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.|Baseline, Month 24|All enrolled patients|||Percentage of Patients|||Number
2656216|NCT01618266|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.|Baseline, Week 6, Month 4, Month 12, Month 18, Month 24|All enrolled patients|||Letters||Standard Deviation|Mean
2656217|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Patients Receiving Ozurdex® and Then Other RVO Treatments|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients were previously treated with Ozurdex® and then switched to other RVO treatment during the study.|Baseline, Month 6|All enrolled patients receiving Ozurdex® and then other RVO treatments|||Letters||Standard Deviation|Mean
2656218|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Patients Only Treated With Ozurdex®|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients had only been previously treated with Ozurdex®.|Baseline, Month 6|All enrolled patients only treated with Ozurdex|||Letters||Standard Deviation|Mean
2656220|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye Based on Macular Edema Onset <3 Months|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. The onset of macular edema was <3 months prior to treatment.|Baseline, Month 6|All enrolled patients with macular edema onset <3 months|||Letters||Standard Deviation|Mean
2656221|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Patients Previously Naïve to Ozurdex® Treatment|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Patients naive to Ozurdex® have not been previously treated for retinal vein occlusion.|Baseline, Month 6|All enrolled patients previously naïve to Ozurdex® treatment|||Letters||Standard Deviation|Mean
2656222|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Patients Previously Treated With Ozurdex®|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Previous treatment for retinal vein occlusion was Ozurdex®.|Baseline, Month 6|All enrolled patients previously treated with Ozurdex®|||Letters||Standard Deviation|Mean
2656223|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye in Previously Treatment Naïve Patients|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. Treatment naïve patients have not been previously treated for retinal vein occlusion.|Baseline, Month 6|All enrolled patients who were treatment naïve|||Letters||Standard Deviation|Mean
2656224|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye Diagnosed With Central Retinal Vein Occlusion (CRVO)|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. CRVO is a blockage of the main vein in the retina.|Baseline, Month 6|All enrolled patients with CRVO|||Letters||Standard Deviation|Mean
2656225|NCT01618266|Secondary|Change From Baseline in BCVA in the Study Eye Diagnosed With Branch Retinal Vein Occlusion (BRVO)|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened. BRVO is a blockage of the small veins in the retina.|Baseline, Month 6|All enrolled patients with BRVO|||Letters||Standard Deviation|Mean
2656226|NCT01618266|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number change in the number of letters read means that the vision improved and a negative number change in the number of letters read means that the vision has worsened.|Baseline, Month 6|All enrolled patients|||Letters||Standard Deviation|Mean
2656227|NCT01618240|Secondary|Number of Patients With Muscle Weakness (MRC<48) Who Developed Clinical Aspiration||Within 3 month follow-up||||participants|||Number
2656228|NCT01618240|Primary|Muscle Strength|We use Medical Research Council (MRC) scale (0-60) to evaluate the degree of muscle weakness in the tracheostomized patients.|Within 24 hours of fiberoptic endoscopic evaluation of swallow||||participants|||Number
2656229|NCT01618227|Secondary|Number of Additional Surgeries|The number of additional surgeries will be recorded and compared between groups.|6 months||||Number of Additional Surgeries|||Number
2656230|NCT01618227|Secondary|Number of Physical/Occupational Therapy Visits|Number of physical/occupational therapy visits will be collected from enrollment.|6 months||||visits||Standard Deviation|Mean
2656231|NCT01618227|Secondary|Wrist Range of Motion|Flexion and extension of the wrist will be measured with a goniometer in degrees, the sum of which will determine range of motion.|6 months|Two subjects had the same range of motion at 6 months, therefore SD is 0.|||degrees||Standard Deviation|Mean
2656232|NCT01618227|Primary|Wrist Range of Motion|Flexion and extension of the wrist will be measured with a goniometer in degrees, the sum of which will determine range of motion.|2 months||||degrees||Standard Deviation|Mean
2656252|NCT01618019|Primary|Dose of NSAID|Daily non-steroidal anti-inflammatory drug (NSAID) requirements as mg/day|16 week|Per-protocol analysis (except for drop out patients) Measurement of NSAID requirements at 16 weeks, except for 10 in N-3 PUFA and 6 in placebo.|||mg||Standard Deviation|Mean
2656283|NCT01617655|Secondary|Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Apo A-1 ITT population.|||percent change||Standard Error|Least Squares Mean
2656233|NCT01618214|Secondary|Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)|Definition of a treatment emergent hypoglycemic episode: an episode occurred after the first administration of insulin or oral anti-diabetic drug, and no later than the last day on trial product. Severe hypoglycemic episode was that requiring assistance to administer carbohydrate, glucagon, or other resusciative actions. Minor hypoglycemic episode was the one with plasma glucose value < 3.1 mmol/L, either with symptoms that could be handled by subject, or without symptoms.|Week 0 to week 20 (inclusive).|Safety Analysis Set (SAS) included all subjects receiving at least one dose of biphasic insulin aspart 30.|||events per patient per year|||Number
2656234|NCT01618214|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose)||Week 0, week 20|Full analysis set (FAS) - included all randomized subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomization measurements were available. Seven subjects did not contribute to FAS due to lack of post-randomization measurements.|||mmol/L||Standard Deviation|Mean
2656235|NCT01618214|Secondary|Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%||After 20 weeks of treatment|Full analysis set (FAS) - included all randomized subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomization measurements were available.|||percentage (%) of subjects|||Number
2656236|NCT01618214|Secondary|Percentage of Subjects Achieving HbA1c Below 7.0%||After 20 weeks of treatment|Full analysis set (FAS) - included all randomized subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomization measurements were available.|||percentage (%) of subjects|||Number
2656237|NCT01618214|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).|Week 0, week 20|Full analysis set (FAS) - included all randomised subjects and missing data was imputed using last observation carried forward (LOCF) where any post-randomisation measurements were available. Six subjects did not contribute to FAS due to lack of post-randomisation measurements.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2656238|NCT01618162|Secondary|Number of Adverse Events (AEs)|An AE was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Reported values are hypoglycemia event rate per 100 PYE.|After 26 weeks of treatment|Safety analysis set.|||event rate per 100 PYE|||Number
2656239|NCT01618162|Secondary|Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes|"An event was treatment emergent if the onset of the episode occurs after the first administration of trial product and no later than 7 days after last trial product administration.~Confirmed hypoglycaemic episodes were defined as hypoglycaemic episodes that were either severe or minor.~Minor hypoglycaemic episodes were defined as:~An episode with symptoms consistent with hypoglycaemia and confirmed by blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) and which was handled by the subject himself/herself.~Any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or blood glucose value <2.8 mmol/L (50 mg/dL).~Severe hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.~Reported values are hypoglycemia event rate per 100 patient-years of exposure (PYE)."|After 26 weeks of treatment|Safety analysis set included all subjects receiving at least one dose of the trial product.|||event rate per 100 PYE|||Number
2656240|NCT01618162|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight at week 26.|Week 0, week 26|Full analysis set.|||kilogram||Standard Deviation|Mean
2656241|NCT01618162|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in FPG at week 26.|Week 0, week 26|Full analysis set. Number of subjects analyzed=subjects with data available for FPG.|||mmol/L||Standard Deviation|Mean
2656242|NCT01618162|Secondary|Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)|Percentage of subjects having HbA1c below 6.5% at week 26|Week 26|Full analysis set.|||percentage of subjects|||Number
2656243|NCT01618162|Secondary|Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)|Percentage of subjects having HbA1c below 7% at week 26.|Week 26|Full analysis set.|||percentage of subjects|||Number
2656244|NCT01618162|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change in HbA1c from baseline to 26 weeks.|Week 0, Week 26|Full analysis set.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2656245|NCT01618019|Secondary|CTX Concentration|serum C-terminal telopeptide of type 1 collagen concentration as nmol/L|16 week|Per-protocol analysis (except for drop out patients) serum C-terminal telopeptide of type 1 collagen concentration at 16 week|||nmol/L||Standard Error|Mean
2656246|NCT01618019|Secondary|BSAP Concentration|serum bone specific alkaline phosphatase concentration as U/L|16 week|Per-protocol analysis (except for drop out patients) serum bone specific alkaline phosphatase concentration at 16 week|||U/L||Standard Deviation|Mean
2656247|NCT01618019|Secondary|Osteocalcin Concentration|serum Osteocalcin concentration as nmol/L|16 week|Per-protocol anlysis (except for drop out patients) serum Osteocalcain concentration at 16 week|||nmol/L||Standard Deviation|Mean
2656248|NCT01618019|Secondary|Pain Scale|Pain scale is ranged from 0 to 100. (0= no pain; 100= severe pain)|16 week|Per-protocol analysis (except for drop out patients) Measurement of Pain scale at 16 week.|||units on a scale||Standard Deviation|Mean
2656249|NCT01618019|Secondary|Patient's Global Assessment|Patient's global assessment is patient self-assessed disability. (0= better condition; 10= very worse condition)|16 week|Per-protocol analysis (except for drop out patients) Measurement of Patient’s global assessment at 16 week.|||units on a scale||Standard Deviation|Mean
2656250|NCT01618019|Secondary|Physician's Global Assessment|"Physician's global assessment is ranged from 0 to 10 by the assessing physician.~(0= no pain; 10= very severe pain)"|16 week|Per-protocol analysis (except for drop out patients) Measurement of Physician’s global assessment at 16 weeks.|||units on a scale||Standard Deviation|Mean
2656251|NCT01618019|Secondary|Duration of Morning Stiffness|Duration of morning stiffness means that patients with rheumatoid arthritis feel those joints stiff when they wake up in the morning.|16 week|Per-protocol analysis (except for drop out patients) Measurement of Morning stiffness assessment at 16 weeks, except for 16 in N-3 PUFA and 16 in placebo|||minutes||Standard Deviation|Mean
2668013|NCT01509677|Secondary|Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (VEGF(pg/mL))||Baseline to 14 weeks||||pg/mL||Standard Error|Least Squares Mean
2656253|NCT01617967|Secondary|Pharmacokinetic Parameters of Patisiran - Renal Clearance (CLR)|Pharmacokinetic profiles for patisiran were determined based on dosage and dosing frequency only, not premedication regimens. For arms with a dosing regimen of Q4W PK samples were taken on Days 0 and 28. For the arm with a dosing regimen of Q3W PK samples were taken on Days 0 and 21.|Predose (within 1 h of planned dosing start) and post-infusion at 0-6 h (pooled) on Day 0 and Day 21/28 depending on dosing frequency|The pharmacokinetic (PK) population included all participants, who received at least one dose of patisiran and had adequate data to determine a full pharmacokinetic profile. For PK outcome measures the two arms for patisiran 0.300 mg/kg at a dosing frequency of Q3W were combined and reported irrespective of premedication regimen.|||mL/h/kg||Standard Deviation|Mean
2656254|NCT01617967|Secondary|Pharmacokinetic Parameters of Patisiran - Apparent Volume of Distribution at Steady State (Vss)|Pharmacokinetic profiles for patisiran were determined based on dosage and dosing frequency only, not premedication regimens. For arms with a dosing regimen of Q4W PK samples were taken on Days 0 and 28. For the arm with a dosing regimen of Q3W PK samples were taken on Days 0 and 21.|Predose, end of infusion and post-infusion at 5 minutes (min), 10 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 24 h and 48 h on Day 0 and Day 21/28 depending on dosing frequency|The pharmacokinetic (PK) population included all participants, who received at least one dose of patisiran and had adequate data to determine a full pharmacokinetic profile. For PK outcome measures the two arms for patisiran 0.300 mg/kg at a dosing frequency of Q3W were combined and reported irrespective of premedication regimen.|||L/kg||Standard Deviation|Mean
2656255|NCT01617967|Secondary|Pharmacokinetic Parameters of Patisiran - Systemic Clearance (CL)|Pharmacokinetic profiles for patisiran were determined based on dosage and dosing frequency only, not premedication regimens. For arms with a dosing regimen of Q4W PK samples were taken on Days 0 and 28. For the arm with a dosing regimen of Q3W PK samples were taken on Days 0 and 21.|Predose, end of infusion and post-infusion at 5 minutes (min), 10 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 24 h and 48 h on Day 0 and Day 21/28 depending on dosing frequency|The pharmacokinetic (PK) population included all participants, who received at least one dose of patisiran and had adequate data to determine a full pharmacokinetic profile. For PK outcome measures the two arms for patisiran 0.300 mg/kg at a dosing frequency of Q3W were combined and reported irrespective of premedication regimen.|||L/h/kg||Standard Deviation|Mean
2656256|NCT01617967|Secondary|Pharmacokinetic Parameters of Patisiran - Beta Elimination Half-life (t1/2 Beta)|Pharmacokinetic profiles for patisiran were determined based on dosage and dosing frequency only, not premedication regimens. For arms with a dosing regimen of Q4W PK samples were taken on Days 0 and 28. For the arm with a dosing regimen of Q3W PK samples were taken on Days 0 and 21.|Predose, end of infusion and post-infusion at 5 minutes (min), 10 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 24 h and 48 h on Day 0 and Day 21/28 depending on dosing frequency|The pharmacokinetic (PK) population included all participants, who received at least one dose of patisiran and had adequate data to determine a full pharmacokinetic profile. For PK outcome measures the two arms for patisiran 0.300 mg/kg at a dosing frequency of Q3W were combined and reported irrespective of premedication regimen.|||hour (h)||Standard Deviation|Mean
2656257|NCT01617967|Secondary|Pharmacokinetic Parameters of Patisiran - Maximum Observed Plasma Concentration (Cmax)|Pharmacokinetic profiles for patisiran (ALN-TTR02) were determined based on dosage and dosing frequency only, not premedication regimens. For arms with a dosing regimen of Q4W PK samples were taken on Days 0 and 28. For the arm with a dosing regimen of Q3W PK samples were taken on Days 0 and 21.|Predose, end of infusion and post-infusion at 5 minutes (min), 10 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 24 h and 48 h on Day 0 and Day 21/28 depending on dosing regimen (Q3W/Q4W)|The pharmacokinetic (PK) population included all participants, who received at least one dose of patisiran and had adequate data to determine a full pharmacokinetic profile. For PK outcome measures the two arms for patisiran 0.300 mg/kg at a dosing frequency of Q3W were combined and reported irrespective of premedication regimen.|||ng/mL||Standard Deviation|Mean
2656258|NCT01617967|Secondary|Pharmacokinetic Parameters of Patisiran - Area Under the Concentration Curve From Time 0 to Last Measurable Time Point (AUC0-last)|Pharmacokinetic profiles for patisiran (ALN-TTR02) were determined based on dosage and dosing frequency only, not premedication regimens. For arms with a dosing regimen of Q4W PK samples were taken on Days 0 and 28. For the arm with a dosing regimen of Q3W PK samples were taken on Days 0 and 21.|Predose, end of infusion and post-infusion at 5 minutes (min), 10 min, 30 min, 1 hour (h), 2 h, 4 h, 6 h, 24 h and 48 h on Day 0 and Day 21/28 depending on dosing regimen (Q3W/Q4W)|The pharmacokinetic (PK) population included all participants, who received at least one dose of patisiran and had adequate data to determine a full pharmacokinetic profile. For PK outcome measures the two arms for patisiran 0.300 mg/kg at a dosing frequency of Q3W were combined and reported irrespective of premedication regimen.|||ng*h/mL||Standard Deviation|Mean
2656259|NCT01617967|Secondary|Percentage Change From Baseline in Serum Transthyretin (TTR) Protein|Percentage change of TTR relative to pretreatment/baseline levels is reported. For arms with a dosing regimen of Q4W TTR protein samples were measured on Days 28 and 56. For the arms with a dosing regimen of Q3W TTR protein samples were measured on Days 21 and 42.|Baseline to Day 21/28 and Day 42/56 depending on dosing regimen (Q3W/Q4W)|ITT population included all participants, who received at least 1 dose of study drug.|||Percentage||Standard Deviation|Mean
2656260|NCT01617967|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Drug Discontinuation|The number of participants experiencing at least one adverse event (AE), at least one serious adverse event (SAE) and study drug discontinuation (due to any reason).|Up to 56 days post first dose|Intent-to-treat (ITT) population included all participants, who received at least 1 dose of study drug.|||Participants|||Count of Participants
2656261|NCT01617681|Secondary|CKD Patients Achieving Urine Albumin Creatinine Ratio Percentage Reduction (UACR) >=25% at Week 6|UACR response is defined as percentage change from baseline in UACR≤ 25%. UACR [mg/mmol] = urine albumin [mg/L] / urine creatinine [mmol/L] UACR was collected for CKD patients only. The UACR value at a given visit for a patient was to be derived by the median of the three lab values collected for that visit Week 6.|Week 6 weeks|Full analysis set (FAS) included all randomized patient except for 1 patient that guardian did not sign informed consent - CKD patients only The number of patients with an UACR at baseline and week 6 endpoint (included in the analysis).|||participants|||Number
2656348|NCT01617148|Secondary|Percentage of Patients Who Lost Greater Than 15 Letters of Vision From Baseline at 12 Months|The percentage of patients who lost greater than 15 letters of vision from baseline at 12 months.|baseline and 12 months||||Participants|||Count of Participants
2656263|NCT01617681|Secondary|Change From Baseline in Mean Diastolic Blood Pressure (MDBP) at Week 6|Patient's blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) Baseline and Week 6 endpoint in Period 1 Double Blind Phase|Baseline, Week 6|Full analysis set (FAS) included all randomized patient except for 1 patient that guardian did not sign informed consent|||mmHg||Standard Error|Least Squares Mean
2656264|NCT01617681|Primary|Change From Baseline in Mean Systolic Blood Pressure (MSBP) at Week 6 Endpoint|Patient's blood pressure will be measured in the same position at every visit Systolic and diastolic blood pressures will be measured three times at 2-3 minute intervals. The arithmetic mean of these three blood pressure measurements will be used as the mean office blood pressure (MSBP and MDBP) at Baseline and Week 6 endpoint in Period 1 Double Blind Phase|Baseline, week 6|Full analysis set (FAS) included all randomized patient except for 1 patient that guardian did not sign informed consent|||mmHg||Standard Error|Least Squares Mean
2656265|NCT01617668|Secondary|Pharmacokinetics (PK) Parameters of LCL161 Only for AUClast|To evaluate the PK of LCL161 when given in combination with paclitaxel|cycle 1 day 1, cycle 4 day 15|The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161. Only sparse/limited PK samples were collected and analyzed.|||ng*hr/mL||Full Range|Median
2656266|NCT01617668|Secondary|Pharmacokinetics (PK) Parameters of LCL161 Only for Tmax|To evaluate the PK of LCL161 when given in combination with paclitaxel. The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161.|cycle 1 day 1, cycle 4 day 15|The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161. Only sparse/limited PK samples were collected and analyzed.|||h||Full Range|Median
2656267|NCT01617668|Secondary|Pharmacokinetics (PK) Parameters of LCL161 Only for Cmax|To evaluate the PK of LCL161 when given in combination with paclitaxel.|cycle 1 day 1, cycle 4 day 15|The pharmacokinetic analysis set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data for LCL161. Only sparse/limited PK samples were collected and analyzed.|||ng/mL||Full Range|Median
2656268|NCT01617668|Secondary|Caspase 3 Activation in Tumor by Immunohistochemistry (IHC) - EAS2|To evaluate whether combination treatment with LCL161 and paclitaxel is associated with increased apoptosis compared to weekly paclitaxel alone. To evaluate whether combination treatment with LCL161 and paclitaxel was associated with increased apoptosis compared to weekly paclitaxel alone, cleaved caspase 3 activation in tumor by IHC was examined. Cycle = 28 days; each patient had either C1D2 or C1D9|Baseline, Post-baeline at Cycle 1, Day 2 or Cycle 1, Day 9|The Efficacy Analysis Set 2 (EAS2) was the same as EAS1 except that the threshold for classifying a patient into the positive gene group was 0.7716. All the EAS2 set participants were considered for the analysis (N). Only participants (n) who had baseline and post baseline values for the given time point were analyzed for that time point.|||% of positive tumor cells||Standard Deviation|Mean
2656269|NCT01617668|Secondary|Caspase 3 Activation in Tumor by Immunohistochemistry (IHC) - EAS1|"To evaluate whether combination treatment with LCL161 and paclitaxel is associated with increased apoptosis compared to weekly paclitaxel alone. To evaluate whether combination treatment with LCL161 and paclitaxel was associated with increased apoptosis compared to weekly paclitaxel alone, cleaved caspase 3 activation in tumor by IHC was examined.~Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661 (positive: score ≥ 0.6661; negative: score <0.6661); cycle = 28 days; each patient had either C1D2 or C1D9"|Baseline, Post-baeline at Cycle 1, Day 2 (C1D2) or Cycle 1, Day 9 (C1D9)|Efficacy Analysis Set 1 (EAS1) is patients (pts) who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with valid gene expression signature score. All pts were considered for analysis (N). Only pts (n) with baseline & post baseline values for the given time point were analyzed for that time point.|||% of positive tumor cells||Standard Deviation|Mean
2656270|NCT01617668|Secondary|Rates of Breast Conserving Surgery and Mastectomy - Assessed by Percentage of Patients Who Underwent Breast Conserving Surgery, Masectomy and no Surgery|To assess other indicators of disease response for the LCL161 + paclitaxel combination compared to paclitaxel alone. Rates of breast conserving surgery and mastectomy also contributed to the overall assessment of disease response and were summarized by treatment arm within each gene expression signature status. For this analysis, patients with multicentric breast cancer were excluded, as all patients in this group were expected to be treated with mastectomy.|16 weeks|EAS1 - patients receiving at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature (GES) score. GES status is derived based on continuous GES score using cut-off 0.6661(pos: score ≥ 0.6661; neg: score <0.6661). Patients with multicentric breast cancer were excluded.|||Percentage of participants|||Number
2656271|NCT01617668|Secondary|pCR Rate in Breast, Regional Nodes and Axilla|To assess other indicators of disease response for the LCL161 + paclitaxel combination compared to paclitaxel alone. The pCR in breast, regional nodes, and axilla were determined based on the America Joint Committee on Cancer Staging [AJCC] stages T1c, T2, N0-N2, M0) were (AJCC) pathologic staging recorded on the eCRF: a patient was considered to be a responder in breast, regional nodes, and axilla if the pathological complete response was reported for breast and if the regional lymph nodes staging was pN0 (including i-, mol-, mol+).The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score <0.6661)|||Percentage of participants||95% Confidence Interval|Median
2656284|NCT01617655|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2668014|NCT01509677|Secondary|Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (TIMP-1(ng/mL))||Baseline to 14 weeks||||ng/mL||Standard Error|Least Squares Mean
2656272|NCT01617668|Secondary|pCR Rate in Breast After 12 Weeks of Therapy With Single Agent LCL161 and LCL161 + Paclitaxel, Regardless of Gene Signature Status|To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer regardless of tumor gene expression signature status. This comparison is between the 2 study treatments, regardless of gene signature status. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score <0.6661)|||Percentage of participants||95% Confidence Interval|Median
2656273|NCT01617668|Secondary|Posterior Distribution of Difference in pCR Rates After Treatment With Paclitaxel Only Between Gene Expression Positive and Negative Tumors|To assess whether use of the gene expression signature identifies tumors more likely to respond to treatment with paclitaxel only. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score <0.6661)|||Difference in percentage of participants||95% Confidence Interval|Median
2656274|NCT01617668|Secondary|Posterior Distribution of Difference of pCR Rates After Treatment With LCL161 + Paclitaxel Between Patients With Gene Expression Positive and Negative Tumors|To assess whether use of the gene expression signature identifies tumors more likely to respond to treatment with LCL161 and paclitaxel. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|Efficacy Analysis Set 1 (EAS1) are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or of paclitaxel alone with a valid gene expression signature score. Gene expression signature status is derived based on continuous gene expression signature score using cut-off 0.6661(positive: score ≥ 0.6661; negative: score <0.6661)|||Difference in percentage of participants||95% Confidence Interval|Median
2656275|NCT01617668|Primary|Difference in pCR Rates Between Treatment Arms|pCR rate was defined as histopathologically confirmed absence of invasive disease in the breast. To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer. Analyses were performed separately in the gene expression signature negative and positive groups. This analysis was based on the posterior distribution of the difference in pCR rates between the experimental and control arms of the study, within each gene expression signature group.The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). 95% Confidence interval is actually 95% credible interval.|12 weeks|FAS are patients who received at least 1 full or partial dose of LCL161 + paclitaxel or 1 full or partial dose of paclitaxel alone. These values are medians of posterior distribution of difference of pCR rate between treatment arms based on a Bayesian model. 95% Confidence interval is actually 95% credible interval.|||Difference in percentage of participants||95% Confidence Interval|Median
2656276|NCT01617668|Primary|Number of Participants With Pathological Complete Response (pCR) in Breast After 12 Weeks of Therapy|To assess the number of patients who experienced a pathological response in breast.|12 weeks|The Full Analysis Set (FAS) was composed of all patients who received at least one full or partial dose of LCL161 + paclitaxel or one full or partial dose of paclitaxel alone.|||Participants|||Number
2656277|NCT01617668|Primary|Pathological Complete Response (pCR) Rate in Breast After 12 Weeks of Therapy|pCR rate was defined as histopathologically confirmed absence of invasive disease in the breast. To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer. Analyses were performed separately in the gene expression signature negative and positive groups. This analysis was based on Bayesian design using a binomial distribution for the data with a beta prior. The measurement type used for this analysis is posterior median and the method of dispersion is Credible Interval (Crl) and not Confidence Interval (CI). Median values are posterior medians of pCR rate for each group.|12 weeks|The Full Analysis Set (FAS) was composed of all patients who received at least one full or partial dose of LCL161 + paclitaxel or one full or partial dose of paclitaxel alone.|||Percentage of Participants||95% Confidence Interval|Median
2656278|NCT01617655|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 78 i.e. up to 21 days after last injection.|From Baseline to Week 78|mITT population.|||percent change||Standard Error|Least Squares Mean
2656279|NCT01617655|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including all available post-baseline data from Week 4 to Week 78 regardless of status on- or off-treatment.|From Baseline to Week 78|ITT population.|||percent change||Standard Error|Least Squares Mean
2656280|NCT01617655|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|From Baseline to Week 52|mITT population.|||percent change||Standard Error|Least Squares Mean
2656281|NCT01617655|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.|||percentage of participants|||Number
2656282|NCT01617655|Secondary|Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 from multiple imputation approach including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|Up to Week 52|ITT population.|||percentage of participants|||Number
2656286|NCT01617655|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2656287|NCT01617655|Secondary|Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on-or off-treatment (Apo A-1 ITT population).|||percent change||Standard Error|Least Squares Mean
2656288|NCT01617655|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2656289|NCT01617655|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on-or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2656290|NCT01617655|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2656291|NCT01617655|Secondary|Percentage of Very High CV Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|Up to Week 52|mITT population.|||percentage of participants|||Number
2656292|NCT01617655|Secondary|Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis|Very high CV risk participants: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents. High CV risk participants: heFH participants without CHD or CHD risk equivalents. CHD risk equivalent: peripheral arterial disease, ischemic stroke, moderate chronic kidney disease (estimated glomerular filtration rate, 30 to <60 ml/minute/1.73 m^2 of body-surface area), or diabetes mellitus plus 2 or more additional risk factors (hypertension; ankle-brachial index of ≤0.90; microalbuminuria, macroalbuminuria, or a urinary dipstick result of >2+ protein; preproliferative or proliferative retinopathy or laser treatment for retinopathy; or a family history of premature CHD). Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.|||percentage of participants|||Number
2656293|NCT01617655|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from week 4 to week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
2656294|NCT01617655|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
2656295|NCT01617655|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2656296|NCT01617655|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
2656297|NCT01617655|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment (total-C ITT population).|||percent change||Standard Error|Least Squares Mean
2656298|NCT01617655|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).|||percent change||Standard Error|Least Squares Mean
2656299|NCT01617655|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2656349|NCT01617148|Secondary|Percentage of Patients Who Gained Greater Than 15 Letters of Vision From Baseline at 12 Months.|The percentage of patients who gained greater than 15 letters of vision from baseline to 12 months.|baseline and 12 months||||Participants|||Count of Participants
2656300|NCT01617655|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo B mITT population).|||percent change||Standard Error|Least Squares Mean
2656301|NCT01617655|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).|||percent change||Standard Error|Least Squares Mean
2656302|NCT01617655|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.|From Baseline to Week 52|mITT population.|||percent change||Standard Error|Least Squares Mean
2656303|NCT01617655|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
2656304|NCT01617655|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2656305|NCT01617655|Primary|Percent Change From Baseline in Calculated LDL-C at Week 24 - ITT Analysis|Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off- treatment.|||percent change||Standard Error|Least Squares Mean
2656306|NCT01617629|Other Pre-specified|Overall Survival|Overall survival was defined as the time from randomization until death from any cause.|2 years|Due to the few patients, Overall Survival could not be calculated.||||||
2656307|NCT01617629|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the drug. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.|First dose of study vaccine to 30 days past last dose (Approximately 1 Year)|Safety Population included all participants who enrolled in the study.|||participants|||Number
2656308|NCT01617603|Secondary|Oxidative Stress After 12 Weeks of Product Intake|Oxidative stress is assessed from measurements of plasma markers (High sensitivity CRP, IL-1, IL-6, and alpha-TNF) at the 84th day of product intake|84th day of product intake|||||||
2656309|NCT01617603|Secondary|Cholesterol Profile After 12 Weeks of Product Intake|Cholesterol profile is assessed from plasma HDL, LDL and total cholesterol measurements at the 84th day of product intake|84th day of product intake|||||||
2656310|NCT01617603|Secondary|Endothelial Function After 12 Weeks of Product Intake|Endothelial function is assessed from arterial stiffness measurements at the 84th day minus the value at baseline (1st day of product intake)|84th day of product intake|||||||
2656311|NCT01617603|Primary|Difference in Insulin Resistance (HOMA) Between Treatments After 12 Weeks of Product Intake|HbA1c with measurement of plasma glucose and insulin (to determine HOMA index) at the 84th day after product intake minus value at baseline (1st day of product intake. Insulin resistance is defined by a HOMA index > 2.4|84th day of product intake||||HOMA index||Inter-Quartile Range|Mean
2656312|NCT01617577|Primary|Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )|"Scores from each of the cognitive assessments:~mean ADAScog: a decrease in total score units = improvement, min=0 max= mean PAL (memory): an increase in score = improvement, mean PAL (total trial adj): a decrease in score = improvement,"|Baseline and final visit (14 wks)||||units on a scale||Standard Error|Mean
2656313|NCT01617577|Primary|Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )|"Scores from each of the cognitive assessments:~mean ADAScog: a decrease in total score units = improvement, min=0 max=31 mean PAL (memory): an increase in score = improvement, min= 0 max=12 mean PAL (total trial adj): a decrease in score = improvement,"|Baseline and 2wk and 4 wk after Rx;||||units on a scale||Standard Error|Mean
2656314|NCT01617460|Primary|Mean Change From Baseline at the Final Assessment in Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score|The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition.|Baseline, the final administration||||units on a scale||Standard Deviation|Mean
2656315|NCT01617447|Primary|Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score|The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Individual scores were summed, therefore, the overall score range was between 0-45. Higher scores represent worse condition.|baseline, 8 weeks after dosing||||units on a scale||Standard Error|Mean
2656316|NCT01617434|Secondary|Number of Severe Hypoglycaemic Episodes During The Randomised Treatment Period|Severe hypoglycaemia episode was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions.|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the trial products.|||Events/100 years of patient exposure|||Number
2656317|NCT01617434|Secondary|Number of Minor Hypoglycaemic Episodes During The Randomised Treatment Period|A minor hypoglycaemic episode was defined as either, (a) an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL) that was handled by the subject him/herself or (b) any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL).|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the trial products.|||Events/100 years of patient exposure|||Number
2656318|NCT01617434|Secondary|Number of Adverse Events (AEs) During The Randomised Treatment Period|An AE was defined as treatment emergent if the onset date (or increase in severity) was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The adverse events were categorised as 'serious' and 'non-serious' adverse events. Adverse events were also categorised according to the severity as 'mild', 'moderate' and 'severe' adverse events.|Week 0 to Week 26 + 7 days follow up|Safety analysis set includes all subjects who received at least one dose of the trial product.|||Events/1000 years of patient exposure|||Number
2656319|NCT01617434|Secondary|Number of Subjects Achieving HbA1c Below or Equal to 6.5% (American Association of Clinical Endocrinologists [AACE] Target)|Number of subjects achieving HbA1c below or equal to 6.5% (American Association of Clinical Endocrinologists [AACE] target) after 26 weeks of treatment.|At Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product and who provided at least one post-baseline efficacy value. 211 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.|||percentage of subjects|||Number
2656320|NCT01617434|Secondary|Number of Subjects Achieving HbA1c Below 7.0% (American Diabetes Association [ADA] Target)|Number of subjects achieving HbA1c below 7.0% (American Diabetes Association [ADA] target) after 26 weeks of treatment|At Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 211 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.|||percentage of subjects|||Number
2656321|NCT01617434|Secondary|Change in Body Weight From Baseline to Week 26|The estimated mean change in body weight after 26 weeks of treatment.|Week 0 to Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 215 subjects in the liraglutide arm and 216 subjects in the placebo arm contributed to the statistical analysis.|||kg||Standard Deviation|Mean
2656322|NCT01617434|Secondary|Change in Mean Self-Measured Plasma Glucose (SMPG) of 7-Point Profile From Baseline to Week 26|The estimated mean change from baseline in mean SMPG of 7-point profile (7-points were before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime) after 26 weeks of treatment.|Week 0 to Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 191 subjects in the liraglutide arm and 196 subjects in the placebo arm contributed to the statistical analysis.|||mmol/L||Standard Deviation|Mean
2656323|NCT01617434|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26|The estimated mean change from baseline in FPG after 26 weeks of treatment.|Week 0 to Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 213 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.|||mmol/L||Standard Deviation|Mean
2656324|NCT01617434|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 26|The estimated mean change from baseline in HbA1c after 26 weeks of treatment.|Week 0 to Week 26|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial product (liraglutide or placebo) and who provided at least one post-baseline efficacy value. 215 subjects in the liraglutide arm and 217 subjects in the placebo arm contributed to the statistical analysis.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2656325|NCT01617421|Primary|Health-Promoting Lifestyle Profile II Score|Health Promoting Lifestyle Profile (HPLP II) was used to measure the extent to which adults engage in a health-promoting lifestyle - Likert-type scales ranged from (1-never to 4-routinely). Subscales included: spiritual growth, interpersonal relations, nutrition, physical activity, health responsibility, and stress management. The mean value was calculated based on participant responses to all six subscales.|8 weeks||||units on a scale||95% Confidence Interval|Mean
2656326|NCT01617421|Primary|Health-Promoting Lifestyle Profile II Score|Health Promoting Lifestyle Profile (HPLP II) was used to measure the extent to which adults engage in a health-promoting lifestyle - Likert-type scales ranged from (1-never to 4-routinely). Subscales included: spiritual growth, interpersonal relations, nutrition, physical activity, health responsibility, and stress management. The mean value was calculated based on participant responses to all six subscales.|Baseline||||units on a scale||95% Confidence Interval|Mean
2656327|NCT01617421|Primary|Self-Efficacy Exercise|The Chronic Disease Self-Efficacy-Exercise Regularly Scale is a 3-item scale used to measure confidence in exercising regularly based on a Likert scale from 1 (not at all confident) to 10 (totally confident). The mean value was calculated based on participant responses to all three items.|8 weeks||||units on a scale||95% Confidence Interval|Mean
2656328|NCT01617421|Primary|Self-Efficacy Exercise|The Chronic Disease Self-Efficacy-Exercise Regularly Scale is a 3-item scale used to measure confidence in exercising regularly based on a Likert scale from 1 (not at all confident) to 10 (totally confident). The mean value was calculated based on participant responses to all three items.|Baseline||||units on a scale||95% Confidence Interval|Mean
2656350|NCT01617148|Secondary|Change in Cube Average Thickness From Baseline at 12 Months|Mean absolute change in cube average thickness as measured by SDOCT from baseline at 12 months.|baseline and 12 months||||µm||Standard Deviation|Mean
2656329|NCT01617369|Primary|Change in Whole Lung Mucociliary Clearance|"The primary outcome of mucociliary clearance (MCC) will be depicted by calculating the average rate of isotope clearance (%) from the whole lung compartment, measured for 90 minutes after isotope inhalation (MCC-Ave 90), using data points collected every 10 minutes.~Absolute change in MCC-Ave90 from baseline reported for each arm"|30 minutes and 4 hours after inhalation|Per Protocol|||% Clearance||Standard Deviation|Mean
2656330|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 4 items of the Marder anxiety/depression factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor anxiety/depression symptom score for each participant was sum of rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
2656331|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 4 items of the Marder hostility/excitement factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor hostility/excitement symptom score for each participant was sum of rating assigned to each of the 4 applicable Marder factor items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
2656332|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 7 items of the Marder disorganized thoughts factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor disorganized thought symptom score for each participant was sum of rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
2656333|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 7 items of the Marder negative symptoms factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor negative symptom score for each participant was sum of the rating assigned to each of the 7 applicable Marder factor items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
2656334|NCT01617187|Secondary|Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 8 items of the Marder positive symptom factor of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Marder factors are a modified grouping of the 30 PANSS items. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS Marder factor positive symptom score for each participant was sum of rating assigned to each of the 8 applicable Marder factor items, and ranged from 8 to 56 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
2656335|NCT01617187|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 16 items of the general psychopathology subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess the symptoms of schizophrenia. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS general psychopathology subscale score for each participant was calculated as the sum of the rating assigned to each of the 16 subscale items, and ranged from 16 to 112 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
2656336|NCT01617187|Secondary|Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 7 items of the positive subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS positive subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
2656337|NCT01617187|Secondary|Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42|This measure reports results for the 7 items of the negative subscale of the PANSS, which is a 30-item clinician-rated instrument used to assess schizophrenia symptoms. Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. PANSS negative subscale score for each participant was sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms. Measure reports change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
2656338|NCT01617187|Secondary|Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42|A CGI-I responder was defined as a participant who had a CGI-I score of 1 (very much improved) or 2 (much improved) at a post-baseline assessment. CGI-I is a 7-point scale for assessing the global improvement of the participant's illness relative to baseline, with ratings from 1=very much improved to 7=very much worse. Missing data were imputed by LOCF.|Days 4, 7, 14, 21, 28, 35 and 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||percentage of participants|||Number
2656339|NCT01617187|Secondary|Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35|CGI-S is a 7-point scale for assessing the global severity of the participant's illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28 and 35|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
2656340|NCT01617187|Secondary|Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35|A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by LOCF.|Days 4, 7, 14, 21, 28 and 35|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||percentage of participants|||Number
2656341|NCT01617187|Secondary|Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35|The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline; improvement in symptoms is represented by negative values.|Baseline and Days 4, 7, 14, 21, 28 and 35|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
2656342|NCT01617187|Secondary|Change From Baseline in Body Weight at Day 42|Change from baseline in body weight at Day 42 is the Key Safety Outcome Measure.|Baseline and Day 42|All randomized participants who received ≥1 dose of study drug|||kg||Standard Error|Least Squares Mean
2656343|NCT01617187|Secondary|Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42|Rate of PANSS responders at Day 42 is a Key Secondary Outcome Measure. A PANSS responder was defined as a participant who had a reduction from baseline of at least 30% in the PANSS total score at a post-baseline assessment. The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The Total score is the sum of the ratings for the individual items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. Missing data were imputed by Last Observation Carried Forward (LOCF).|Baseline and Day 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||percentage of participants|||Number
2656344|NCT01617187|Secondary|Change From Baseline in CGI-S Score at Day 42|Change from baseline in CGI-S score at Day 42 is a Key Secondary Outcome Measure. CGI-S is a 7-point scale for assessing the global severity of the participant's illness, with ratings from 1=normal, not ill to 7=very severely ill. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values.|Baseline and Day 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
2656345|NCT01617187|Primary|Change From Baseline in PANSS Total Score at Day 42|The PANSS is a 30-item clinician-rated instrument for assessing schizophrenia symptoms. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 42; improvement in symptoms is represented by negative values.|Baseline and Day 42|FAS, defined as randomized participants who received ≥1 dose of study drug and had both a baseline and ≥1 post-baseline PANSS Total Score|||score on a scale||Standard Error|Least Squares Mean
2656346|NCT01617148|Secondary|Percentage of Subjects Who Were 20/200 or Worse at Month 12.|Percentage of subjects who had visual acuity of 20/200 or worse at month 12.|month 12||||Participants|||Count of Participants
2656347|NCT01617148|Secondary|Percentage of Subjects Who Were 20/40 or Better at Month 12.|Percentage of subjects who had vision acuity of 20/40 or better at month 12.|month 12||||Participants|||Count of Participants
2656351|NCT01617148|Secondary|Change in Macular Volume From Baseline at 12 Months.|Mean absolute change from baseline in macular volume at 12 months.|baseline and 12 months||||mm3||Standard Deviation|Mean
2656352|NCT01617148|Secondary|Change in Best-corrected Visual Acuity From Baseline at 12 Months|The mean absolute change from baseline in best-corrected visual acuity score at 12 months as measured by Eletronic-Early Treatment in Diabetic Retinopathy Scale (E-ETDRS) protocol. There were no sub scales used. These are common methods for ophthalmology studies to report their findings. The scale provided is the Electronic-Early Treatment in Diabetic Retinopathy Scale (E-ETDRS) best corrected visual acuity scale. Values that are higher are considered better and values that are lower are considered worse. Minimum E-ETDRS was 24 E-ETDRS letters and maximum E-ETDRS was 80 E-ETDRS letters.|Baseline and 12 months||||E-ETDRS letters||Standard Deviation|Mean
2656353|NCT01617148|Primary|Change in Central Subfield Thickness From Baseline at 12 Months|The mean absolute change from baseline central subfield thickness at 12 months as measured by SDOCT|baseline and 12 months||||µm||Standard Deviation|Mean
2656354|NCT01617083|Secondary|Screen for Childhood Anxiety-Related Emotional Disorders (SCARED)|The Screen for Childhood Anxiety-Related Emotional Disorders (SCARED) is a 41-item parent and participant-completed tool used to measure symptoms of anxiety, including the most common symptoms of panic/somatic, generalized anxiety, separation anxiety, social phobia, and school phobia. Scores range from 0-82, with higher scores indicating more severe symptoms.The child and parent versions of the SCARED have moderate parent-child agreement and good internal consistency, test-retest reliability, and discriminant validity; it is also sensitive to treatment response (Birmaher et al. 1999). The target population for this rating is 8-18 years of age (Birmaher et al. 1997). The parent and child version of the SCARED were administered before and after week 4 randomization. This measure is not validated for use in 4-7 year olds.|Before and after 4 week randomization||||units on a scale||Standard Error|Mean
2656355|NCT01617083|Secondary|Clinical Global Impressions-Severity OCD|The CGI-S scale is a 7-point clinician rating of severity of psychopathology. Severity ratings range from 1 (no illness) to 7 (extremely severe). This instrument has been successfully used in treatment studies (Cook, et al., 2001; Storch, et al., 2007).|Before and after 4 week randomization||||units on a scale||Standard Error|Mean
2656356|NCT01617083|Primary|Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)|The CYBOCS is a clinician rated, semi-structured interview for rating the severity of OCD (Scahill, et al., 1997). Total scores range from 0 to 50, with higher scores representing greater severity. The total score is comprised of two subscores, obsessions and compulsions, each with a range of 0-25.|Before and after 4 week randomization||||units on a scale||Standard Error|Mean
2656357|NCT01617070|Primary|Urine Dopamine at the End of 4 Weeks|Evaluated for each subject under 4 conditions (washout, LNAA only, Kuvan only and LNAA+Kuvan)|measured every 4 weeks up to 16 weeks|Participates who completed all phases were measured.|||ug/gCreatinine||Standard Deviation|Mean
2656358|NCT01617070|Primary|Urine 6-sulfatoxymelatonin at the End of 4 Weeks|Evaluated for each subject under 4 conditions (washout, LNAA only, Kuvan only and LNAA+Kuvan)|measured every 4 weeks up to 16 weeks|Participates who completed all phases were measured.|||ng/mg Creatinine||Standard Deviation|Mean
2656359|NCT01617070|Primary|Serum Melatonin at the End of 4 Weeks|Evaluated for each subject under 4 conditions (washout, LNAA only, Kuvan only and LNAA+Kuvan)|measured every 4 weeks up to 16 weeks|Participates who completed all phases were measured.|||pg/ml||Standard Deviation|Mean
2656360|NCT01617005|Secondary|Time to Discontinuation Due to Lack of Efficacy||Baseline up to Week 24|As none of the participants discontinued treatment due to lack of efficacy, this outcome measure was not estimable.||||||
2656361|NCT01617005|Secondary|Number of Participants Who Discontinued Treatment Due to Lack of Efficacy||Baseline up to Week 24|All participants enrolled in the study.|||participants|||Number
2656362|NCT01617005|Secondary|Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria|EULAR response was based on 28-joint disease activity score (DAS28). The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) in DAS28 score and the level of disease activity reached (absolute DAS28 score). Good responders had a CFB greater than (>) 1.2 with a DAS28 score less than or equal to (<=) 3.2; moderate responders had a CFB >1.2 with a DAS28 score >3.2 to <= 5.1 or a change from baseline >0.6 to <= 1.2 with a DAS28 score <= 5.1; non-responders had a CFB <=0.6 or CFB >0.6 to <=1.2 with DAS28 >5.1. Number of participants who achieved EULAR good response and EULAR moderate response were reported.|Baseline, Week 24|All participants enrolled in the study.|||participants|||Number
2656363|NCT01617005|Primary|Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include both SAEs as well as non-serious AEs.|Baseline up to Week 24|All participants enrolled in the study.|||participants|||Number
2656364|NCT01616953|Secondary|Implant Stabilization|The ability of the dental implant fixtures to be loaded and remain stable for six months following implant loading (at 4 months) will be evaluated.|10 months||||participants|||Number
2656365|NCT01616953|Primary|Bone Regeneration|The primary outcome variables for bone regeneration will be measured by histological and microcomputed tomographic (μCT) analyses at 4 months post-grafting.|4 months||||implant sites||Standard Deviation|Mean
2656366|NCT01616771|Secondary|The Differences in the Glottis View (C&L Grade) of GVL Selected by Weight and Smaller Sized GVL|"Glottis view was scored using C&L grade by GVL selected by weight and smaller sized GVL, and compared each other.~Score range for the data reported in the table was between 1 and 6, with 1 representing best view and 6 representing no view."|up to 1day of surgery|Four of 23 patients could not be evaluated by smaller sized GVL because there was no smaller blade than their GVL selected by weight.|||units on a scale||95% Confidence Interval|Median
2656415|NCT01615939|Secondary|Pain Control|Numeric rating score for pain (NRS) 0 to 10 scale where 0 equals no pain and 10 equals the worst pain imaginable|72 hrs||||units on a scale||Inter-Quartile Range|Median
2656416|NCT01615939|Secondary|Participant Satisfaction With Anesthesia|Patient satisfaction on a 0 to 10 scale with 0 equals completely dissatisfied and 10 equals completely satisfied|24 hours||||units on a scale||Inter-Quartile Range|Median
2656367|NCT01616771|Primary|The Differences in the Glottis View (C&L Grade) of Macintosh Laryngoscope and GVL Selected by Weight.|"Glottis view was scored using C&L grade by Macintosh laryngoscope and GVL selected by weight, and compared each other.~We used modified C&L grade: grade 1, all or most of the glottic aperture was visible; grade 2a, posterior cords and cartilage visible; grade 2b, only posterior cartilage visible; grade 3a, epiglottis visible and can be lifted; grade 3b, epiglottis adherent to the posterior pharynx; and grade 4, the epiglottis could not be visualized.~For the statistical analysis, the modified C&L grade was converted to an ordinal scale; grade 1 to 1, grade 2a to 2, grade 2b to 3, grade 3a to 4, grade 3b to 5, and grade 4 to 6. Therefore, score range for the data reported in the table was between 1 and 6, with 1 representing best view and 6 representing no view."|up to 1 day of surgery||||units on a scale||95% Confidence Interval|Median
2656368|NCT01616693|Secondary|Serious Adverse Events (SAEs)|Field workers documented information on SAEs through the duration of the study during home visits (twice weekly between study clinic visits) or SAEs were documented by study clinicians at the study clinic or hospital. All SAEs occurring at any time during the study were recorded on a SAE Form and were reviewed and evaluated by a study clinician and the local IRB. The relationship of the SAE to study vaccine was evaluated and recorded and reported to the local institutional review board (IRB). All SAEs were followed until satisfactory resolution.|from first day of study to 4 weeks after last dose||||Participants|||Count of Participants
2656369|NCT01616693|Secondary|Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 2|Shedding of rotavirus following vaccination through detection of rotavirus antigen by ELISA and confirmed as vaccine type by RT-PCR. Stool samples were collected on Day 0 (i.e., day of vaccination or -1), Day 4 (±1) and Day 7 (-1 to +2) post vaccination.|0, 4 and/or 7 day post dose 2 of rotavirus vaccine|Subjects who received the vaccination on schedule and had valid stool samples on the days of testing.|||Participants|||Count of Participants
2656370|NCT01616693|Secondary|Number/Percentage of Subjects Exhibiting Rotavirus Shedding in Stool After Dose 1|Shedding of rotavirus following vaccination through detection of rotavirus antigen by ELISA and confirmed as vaccine type by Real-time polymerase chain reaction (RT-PCR). Stool samples were collected on Day 0 (i.e., day of vaccination or -1), Day 4 (±1) and Day 7 (-1 to +2) post vaccination.|0, 4 and/or 7 day post dose 1 of rotavirus vaccine|Subjects who received the vaccination on schedule and had valid stool samples on the days of testing.|||Participants|||Count of Participants
2656371|NCT01616693|Secondary|Number/Percentage of Subjects With Immune Response to Trivalent Oral Poliovirus Vaccine (OPV)|"A serologic immune response to OPV is defined as a neutralizing antibody titer to polio virus subtype 3 greater than or equal to 1:8 at 14 weeks of age. This antigen will be used as a conservative estimate because it gives the lowest immune response of all three polio antigens.~Pre-vaccination blood samples were taken when the subject received the first dose of OPV vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of OPV was administered (14 weeks of age)."|from first dose of OPV to 4 weeks after last dose of OPV||||Participants|||Count of Participants
2656372|NCT01616693|Primary|Geometric Mean Concentration of Rotavirus-specific IgA|"Pre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus was administered (14 weeks of age).~Pre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus vaccine was administered (14 weeks of age)."|from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine||||titer||95% Confidence Interval|Geometric Mean
2656373|NCT01616693|Primary|Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine|"Defined as an increase in serum anti-rotavirus (RV) VP6 IgA antibodies consistent with seroconversion (detection of serum anti-RV VP6 immunoglobulin A (IgA) antibodies at a concentration ≥20 U/ml in a previously seronegative individual) or a fourfold rise in anti-RV VP6 IgA antibodies between baseline and 14 weeks of age.~Pre-vaccination blood samples were taken when the subject received the first dose of rotavirus vaccine (when the subject was 6 weeks of age); post-vaccination blood samples were taken 4 weeks after the second dose of rotavirus vaccine was administered (14 weeks of age)."|from first dose of rotavirus vaccine to 4 weeks after last dose of vaccine||||Participants|||Count of Participants
2656374|NCT01616576|Primary|Device-related Adverse Events|Device-related adverse events will be assessed to determine whether they impact current device safety performance.|2 weeks||||Events|||Number
2656375|NCT01616576|Primary|Speech Perception With Control and Experimental Conditions Both Tested in Quiet, in Speech-spectrum Noise, and in Multi-talker Babble Noise.|Sentence recognition with the new (experimental) and current (control) sound processing strategies will be compared. Subjects will be tested using the AzBio corpus of sentences, which consists of 33 lists of 20 sentences each (6 to 10 words per sentence) that are equated for intelligibility. The difference between the Control percent correct scores and Experimental percent correct scores will be used for the analysis (Experimental AzBio scores minus Control AzBio scores). Data from both Group A and Group B were pooled for the analysis.|2 weeks||||Percent Correct||Standard Deviation|Mean
2656376|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C During the Booster Phase of the Study|No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.|At study Month 11, e. g. at one month post-Booster vaccination with pneumococcal vaccine|The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Booster Phase but no analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.||||||
2656377|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C During the Primary Phase of the Study|No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase but no analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.||||||
2656417|NCT01615939|Primary|Temporary Neurologic Symptoms Between Groups|Temporary neurologic symptoms between groups; muscle weakness of either foot dorsiflexion and plantar flexion|1 month||||percentage of total participants|||Number
2656378|NCT01616459|Secondary|Antibody Concentrations Against Pneumococcal Serotype 6C During the Booster Phase of the Study.|No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.|At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine|The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Booster Phase but no analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.||||||
2656379|NCT01616459|Secondary|Antibody Concentrations Against Pneumococcal Serotype 6C During the Primary Phase of the Study.|No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase. But no analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available||||||
2656380|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Booster Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 19A (OPA-19A). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) serotype-specific Lower Limit of Quantification (143).|At study Month 11, e. g. at one month post-Booster vaccination with pneumococcal vaccine|The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.|||Titers||95% Confidence Interval|Geometric Mean
2656381|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Primary Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 19A (OPA-19A). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) serotype-specific Lower Limit of Quantification (143).|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.|||Titers||95% Confidence Interval|Geometric Mean
2656382|NCT01616459|Secondary|Antibody Concentrations Against Pneumococcal Serotype 6A During the Booster Phase of the Study|Antibodies assessed for this outcome measure was that against the cross-reactive pneumococcal serotype 6A (ANTI-6A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.|At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine|The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.|||µg/mL||95% Confidence Interval|Geometric Mean
2656383|NCT01616459|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|From Day 0 to Month 11|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases.|||Participants|||Count of Participants
2656384|NCT01616459|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)During the Primary Phase of the Study|A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.|From Month 0 to Month 3|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases.|||Participants|||Count of Participants
2656385|NCT01616459|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Booster Phase of the Study|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases.|||Participants|||Count of Participants
2656418|NCT01615822|Secondary|MQ Cmax|Peak Plasma Concentration (Cmax) of MQ|Up to 42 days post-dose|Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2656386|NCT01616459|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Primary Phase of the Study|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.|Within the 31-day (Days 0-30) period post primary vaccination, across doses|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases.|||Participants|||Count of Participants
2656387|NCT01616459|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C.|Within the 4-day (Days 0-3) period after booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Participants|||Count of Participants
2656388|NCT01616459|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C.|Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D).|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Participants|||Count of Participants
2656389|NCT01616459|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within the 4-day (Days 0-3) period after booster vaccination|The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Participants|||Count of Participants
2656390|NCT01616459|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).|Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D).|The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.|||Participants|||Count of Participants
2656391|NCT01616459|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study|Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL.|At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine|The analysis was performed on the ATP cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2656392|NCT01616459|Secondary|Concentrations of Antibodies Against Protein D (Anti-PD) During the Primary Phase of the Study|Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL.|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2656419|NCT01615822|Secondary|MQ AUC0-t|Area under the plasma concentration versus time curve (AUC) of MQ|Up to 42 days post-dose|Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2656393|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. Testing for opsonophagocytic activity against the cross-reactive pneumococcal serotype 6C will not be performed due to unavailability of a specific qualified assay.|At study Month 11, e.g.: at one month post booster vaccination with pneumococcal vaccine|The analysis was performed on the ATP cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.|||Titers||95% Confidence Interval|Geometric Mean
2656394|NCT01616459|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. Testing for opsonophagocytic activity against the cross-reactive pneumococcal serotype 6C will not be performed due to unavailability of a specific qualified assay.|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.|||Titers||95% Confidence Interval|Geometric Mean
2656395|NCT01616459|Secondary|Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Analysis of concentrations of antibodies against the cross-reactive pneumococcal serotype 6C (ANTI-6C) will not be performed due to unavailability of a specific qualified assay.|At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine|The analysis was performed on the ATP cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.|||µg/mL||95% Confidence Interval|Geometric Mean
2656396|NCT01616459|Primary|Percentage (%) of Subjects (Prevnar13 and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-6A and 19A Pneumococcal Serotypes|N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotype 6A and 19A (ANTI-6A and 19A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).|1 month post-dose 3 (primary phase)|The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.|||Percentage of participants|||Number
2656397|NCT01616459|Primary|Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes|N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).|1 month post-dose 3 (primary phase)|The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.|||Percentage of participants|||Number
2656398|NCT01616459|Primary|Percentage (%) of Subjects (Prevnar13 and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-19A Pneumococcal Serotype|N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotype 19A (ANTI-19A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).|1 month post-dose 3 (primary phase)|The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.|||Percentage of participants|||Number
2656399|NCT01616459|Primary|Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes|N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).|1 month post-dose 3 (primary phase)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.|||Percentage of participants|||Number
2668015|NCT01509677|Secondary|Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (MCP-1(pg/mL))||Baseline to 14 weeks||||pg/mL||Standard Error|Least Squares Mean
2656400|NCT01616459|Primary|Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study|Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Primary outcome results correspond to antibody concentrations for all serotypes presented at the exception of those for the antibodies against the cross-reactive pneumococcal serotype 3 (ANTI-3).|At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine|The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.|||µg/mL||95% Confidence Interval|Geometric Mean
2656401|NCT01616173|Secondary|Pain Scores|Patients were asked to rate their pain score during activity on a 11-point scale (0 = no pain to 10 = excruciating pain).|2 weeks||||units on a scale||Inter-Quartile Range|Median
2656402|NCT01616173|Secondary|Opioid Consumption|Postoperative opioid consumption was converted to equivalent dose of oral morphine at two weeks following surgery.|2 weeks||||mg/day||Inter-Quartile Range|Median
2656403|NCT01616173|Primary|Quality of Recovery|QoR-40 questionnaire instrument consists of 40 questions that examine 5 domains of patient recovery using a 5 point Likert scale: none of the time, some of the time, usually, most of the time and all of the time. The five domains include physical comfort, pain, physical independence, psychological support and emotional state. Global QoR-40 scores range from minimum of 40 to a maximum of 200. The scores are added together to compute a total score. A low score of 40 represents very poor quality of recovery while a high score, i.e. 200 represents outstanding quality of recovery.|2 weeks||||units on a scale||Inter-Quartile Range|Median
2656404|NCT01616160|Primary|Change in Steroid Sensitivity in Vivo Nasal Endoscopy Polyp Scores|To assess steroid sensitivity in subjects comparing nasal endoscopy polyp score before and following 4 weeks treatment with mometasone furoate nasal spray (MFNS). Nasal endoscopic polyp score measured on 0 to 4 scale ( 0 = no nasal polyp; 1 = polyp in the middle meatus, not below the inferior border of the middle turbinate (MT); 2 = polyp below the inferior border of the MT but not touching the inferior turbinate (IT); 3 = polyp below the inferior border of the MT and touching the IT; 4 = polyp to or below the lower border of the IT). The outcome is the difference in mean score (Post - Pre). A negative difference would indicate that patients had a reduction in nasal polyp size at the end of the study.|Change between pre- and post-treatment symptom score after 4 weeks of treatment|Each subject received Nasonex (mometasone furoate) 2 spray per nostril twice daily for 4 weeks.|||units on a scale||Standard Deviation|Mean
2656405|NCT01616160|Primary|Change in Steroid Sensitivity in Vivo Symptom Scores - Trouble With Sense of Smell|To assess steroid sensitivity in subjects comparing Trouble with sense of smell symptom scores before and following 4 weeks treatment with mometasone furoate nasal spray (MFNS). Trouble with sense of smell measured on 0 to 4 scale ( 0 = no trouble with smell; 4 = severe trouble with smell). The outcome is the difference in mean score (Post - Pre). A negative difference would indicate patients had less trouble with sense of smell at the end of the study.|Change between pre- and post-treatment symptom score after 4 weeks of treatment||||scores on a scale||Standard Deviation|Mean
2656406|NCT01616056|Secondary|Change in Optical Coherence Tomography|Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.|2 weeks|Optical coherence tomography results were not analyzed because of incomplete data collection.||||||
2656407|NCT01616056|Secondary|Change in Comprehensive Ophthalmologic Evaluations|LogMAR visual acuity score of 0 is equivalent to 20/20 vision. Patients were assessed by ophthalmologists at enrollment, 2 weeks and afterwards as medical needed.|2 weeks|Ophthalmology assessments made after 2 weeks were not analyzed because of incomplete data collection.|||logMAR||Standard Deviation|Mean
2656408|NCT01616056|Secondary|Number of Patients Who Experienced Serious Adverse Events|Safety of Bandage Contact Lenses at 1 month|1 month||||Participants|||Count of Participants
2656409|NCT01616056|Primary|Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 11-point Eye Scale|The 11-point eye scale goes from 0 not present to 10 as bad as you can imagine. Clinically meaningful change is defined as a 2 point or more decrease.|3 months||||Participants|||Count of Participants
2656410|NCT01616056|Primary|Change in Patient-reported Symptoms as Measured by the 11-point Eye Rating Scale|The 11-point eye scale goes from 0 not present to 10 as bad as you can imagine. Clinically meaningful change is defined as a 2 point or more decrease.|3 months||||units on a scale||Standard Deviation|Mean
2656411|NCT01616056|Primary|Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the OSDI|OSDI minimum score: 0, correlated with better outcome, maximum score: 100, correlated with worse outcome. 12 questions 0 none of the time to 4 all of the time. (Sum of scores)x25/number of questions answered. Clinically meaningful change scores are half a standard deviation, which is 10.9 for the OSDI.|3 months||||Participants|||Count of Participants
2656412|NCT01616056|Primary|Change in Patient-reported Symptoms as Measured by the Ocular Surface Disease Index|OSDI minimum score: 0, correlated with better outcome, maximum score: 100, correlated with worse outcome. 12 questions 0 none of the time to 4 all of the time. (Sum of scores)x25/number of questions answered. Clinically meaningful change scores are half a standard deviation, which is 10.9 for the OSDI.|3 months||||units on a scale||Standard Deviation|Mean
2656413|NCT01616056|Primary|Number of Participants Who Perceived a Clinically Meaningful Change as Measured by the 8-level Lee Eye Symptom Subscale|8-level change score is from 0 completely gone to 7 very much worse. Clinically meaningful improvement is defined as half a standard deviation (decreased score of 11.8 or greater).|3 months||||Participants|||Count of Participants
2656414|NCT01616056|Primary|Change in Patient-reported Symptoms Measured by the 8-point Lee Eye Subscale|Lee eye subscale: sx6 dry eyes, sx7 need to use eye drops frequently, sx8 difficulty seeing clearly 0=not at all, 4=extremely bothered. If have at least one of (sx6,sx7,sx8), then sx_eye=mean(sx6,sx7,sx8)*25. Minimum possible score: 0 correlated with better outcome, maximum score possible: 100 correlated with worse outcome. Clinically meaningful change is half a standard deviation, which is a decrease of 11.8 of more for this scale.|3 months||||units on a scale||Standard Deviation|Mean
2656421|NCT01615822|Primary|OZ439 AUC0-t|Area under the plasma concentration versus time curve (AUC) of OZ439|Up to 42 days post-dose|Only the subjects who completed all treatments in their respective cohort (per-protocol set) were included in the PK population.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2656422|NCT01615809|Secondary|Invasive Pulmonary Aspergillosis -Related Mortality During Primary Prophylaxis With Abelcet®.|Percentage of deaths related to Invasive Pulmonary Aspergillosis during the prophylactic treatment period with Abelcet® in paediatric patients with Acute Leukaemia undergoing intensive chemotherapy.|at the Baseline visit (week 1) and at the end of the profilaxis treatment phase, up to 6 weeks||||percentage of deaths||95% Confidence Interval|Number
2656423|NCT01615809|Secondary|Efficacy of Primary Prophylaxis With Nebulized Abelcet® on the Incidence of Invasive Pulmonary Aspergillosis|The incidence of invasive pulmonary aspergillosis during the Abelcet® prophylactic treatment period was assessed by the relation between the number of patients with invasive pulmonary aspergillosis and the number of paediatric patients on prophylaxis with Acute Leukaemia (AL) undergoing intensive chemotherapy.|at the Baseline visit (week 1) and at the end of the profilaxis treatment phase, up to 6 weeks|At baseline, none of the 32 pediatric patients with acute leukemia included in the clinical trial had API. During the trial period there were 3 patients who developed API|||participants|||Number
2656424|NCT01615809|Primary|Number of Participants With Adverse Events That Results in the Interruption of Treatment, as a Measure of Safety and Tolerability|is assessed by the proportion of patients who discontinue prophylactic treatment with Abelcet® due to an adverse event that is related or not to the study drug or for intolerability to it. The last week of treatment will have a different calendar for each participant, depending on the number of cicles needed by each patient (it has been anticipated up to 5 cicles of 2-6 weeks each).|at the Baseline visit (week 1) and during the Last week of treatment, up to 6 weeks|pediatric patients|||participants|||Number
2656425|NCT01615731|Secondary|Adverse Events|uterine perforation, uterine injury, etc.|Intraoperatively and 2 weeks post operatively||||participants|||Number
2656426|NCT01615731|Secondary|Overall Patient Experience|Used a Visual Analogue Scale to determine the patient's overall satisfaction with her experience. The VAS ranges from 0-100. 0 being a worse than expected experience, 50 being what the patient expected and 100 being a better than expected experience.|Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge||||units on a scale||Inter-Quartile Range|Median
2656427|NCT01615731|Secondary|Pain Perceived by Patient|Used a Visual Analogue Scale to determine the pain perceived by the patient pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively). The VAS ranges from 0-100. 0 being no pain felt by the patient and 100 being the worst pain imaginable felt by the patient.|Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively)||||units on a scale||Inter-Quartile Range|Median
2656428|NCT01615731|Secondary|Ease of Procedure by Blinded Surgeon|Used a Visual Analogue Scale to determine the ease of procedure by blinded surgeon. The VAS ranges from 0-100. 0 being the easiest procedure the surgeon felt they had every performed and 100 being the most difficult procedure imaginable by the surgeon.|Measured Immediately after procedure||||units on a scale||Inter-Quartile Range|Median
2656429|NCT01615731|Secondary|Adverse Events (EBL)|One adverse event: Estimated Blood Loss|Intraoperatively||||mL||Standard Deviation|Mean
2656430|NCT01615731|Secondary|Maximum Cervical Dilation|Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure.|Measured intra-operatively|"Data missing for one subject in Mifepristone plus one set of dilators arm."|||participants|||Number
2656431|NCT01615731|Primary|Total Procedure Time||Measured at clinic visits and on OR day, over a 3 day period|"Data missing for two subjects in Mifepristone plus one set of dilators arm."|||hours||Standard Deviation|Mean
2656432|NCT01615731|Primary|Procedure Time|Measured as time from speculum insertion to removal|Intraoperative Time||||minutes||Standard Deviation|Mean
2656433|NCT01615484|Secondary|Bronchiolitis Obliterans Syndrome (BOS) Free Graft Survival|Bronchiolitis Obliterans Syndrome (BOS) free graft survival at 12 months is being used as a secondary outcome.|12 Months|Excludes those who were deceased at Month 12|||Participants|||Count of Participants
2656434|NCT01615484|Secondary|Recipient Mortality at 12 Months|Recipient mortality at 12 months post transplant is being evaluated as a secondary objective.|12 months||||Participants|||Count of Participants
2656435|NCT01615484|Secondary|Day 7 Ventilator/ECMO Status|Participants' status at Day 7 defined as the following: mechanical ventilation, extra-corporeal membrane oxygenator (ECMO), or extubated.|7 Days Post Transplant.||||Participants|||Count of Participants
2656436|NCT01615484|Secondary|ICU Length of Stay|The length of ICU stay in days is another standard research and clinical outcome assessment post transplant and has been selected as a secondary objective.|Time to Discharge, up to 30 days||||Days||Standard Deviation|Mean
2656437|NCT01615484|Primary|Primary Lung Graft Dysfunction (PGD)|"Primary Lung Graft Dysfunction (PGD) is an indicator for significant morbidity and mortality after lung transplantation.~Grade 0: PaO2/FIO2 > 300 with normal chest radiograph; Grade 1: PaO2/FIO2 > 300 with diffuse infiltrates on the chest radiograph; Grade 2: PaO2/FIO2 between 200 and 300; Grade 3: PaO2/FIO2 < 200."|24 and 72 hours||||Participants|||Count of Participants
2656438|NCT01615484|Primary|30 Day Mortality and Graft Survival|The primary objective evaluated for this study is recipient mortality and graft survival at 30 days post transplant. 30 day mortality and graft survival is used as a standard research assessment to evaluate post transplant outcomes.|30 Days||||Participants|||Count of Participants
2656439|NCT01615367|Secondary|Weekly Exercise Duration|Weekly exercise duration reported at post-treatment.|20 weeks|Results reported here include scores for participants at the post-treatment visit. Thus, these results only include data from participants who did not drop out by week 20 and had data to report.|||minutes||Standard Deviation|Mean
2656440|NCT01615367|Secondary|Body Mass Index (BMI)|Body Mass Index levels at post-treatment.|20 weeks|Results reported here include scores for participants at the post-treatment visit. Thus, these results only include data from participants who did not drop out by week 20 and had data to report.|||kg/m^2||Standard Deviation|Mean
2656441|NCT01615367|Secondary|Young Mania Rating Scale|Young Mania Rating Scale is an 11-item, clinician-rated measure that assesses the presence and severity of patient's current symptoms of mania. The score for each item is summed for a total score that ranges from 0 to 56 with higher scores indicating more severe current manic symptoms.|20 weeks|Results reported here include scores for participants at the post-treatment visit. Thus, these results only include data from participants who did not drop out by week 20 and had data to report.|||units on a scale||Standard Deviation|Mean
2656442|NCT01615367|Secondary|Montgomery Asberg Depression Rating Scale|Montgomery Asberg Depression Rating Scale is a 10-item clinician-rated measure of depression that assesses the presence and severity of patient's current depressive symptoms. The score for each item is summed for a total score that ranges from 0 to 60 with higher scores indicating more severe current depressive symptoms.|20 weeks|Results reported here include scores for participants at the post-treatment visit. Thus, these results only include data from participants who did not drop out by week 20 and had data to report.|||units on a scale||Standard Deviation|Mean
2656443|NCT01615367|Secondary|LIFE- Range of Impaired Functioning Tool|LIFE- Range of Impaired Functioning Tool assesses the extent to which medical burden has impacted current functioning. The score for each domain is summed for a total score that ranges from 4 to 20 with higher scores indicating worse functioning.|20 weeks|Results reported here include scores for participants at the post-treatment visit. Thus, these results only include data from participants who did not drop out by week 20 and had data to report.|||units on a scale||Standard Deviation|Mean
2656444|NCT01615367|Primary|Client Satisfaction Questionnaire-8|"Client Satisfaction Questionnaire-8 is a reliable and valid self-report of participants' acceptability of treatment. This is an assessment of client/patient satisfaction with their care and perceived quality and tolerability of NEW Tx. The scale for this item is a 4-point Likert scale ranging from 1 (poor) to 4 (excellent). The score for each item is summed for a total score that ranges from 8 to 32 with higher scores indicating greater acceptability of the treatment.TAU participants only received this questionnaire if they chose to participate in the NEW Tx at week 20 of the intervention following the waitlist period."|20 weeks|Participants in the treatment as usual condition were not required to complete this assessment if they did not elect to complete the NEW Tx intervention following the waitlist period. Participants completed this survey at the post-treatment visit only. Results only includes data from participants who completed the treatment and had data to report.|||units on a scale||Standard Deviation|Mean
2656445|NCT01615367|Primary|NEW Tx Scale|"NEW Tx Scale is a 10-item scale to asses participants' expectations of NEW Tx their acceptability of NEW Tx at Week 20. This scale also includes a comments section to solicit unstructured feedback from participants on NEW Tx. The scale for this item is a 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The score for each item is summed for a total score that ranges from 10 to 50 with higher scores indicating poorer perception of the treatment. TAU participants only received this questionnaire if they chose to participate in the NEW Tx at week 20 of the intervention following the waitlist period."|20 weeks|Participants in the treatment as usual condition were not required to complete this assessment if they did not elect to complete the NEW Tx intervention following the waitlist period. Participants completed this survey at the post-treatment visit only. Results only includes data from participants who completed the treatment and had data to report.|||units on a scale||Standard Deviation|Mean
2656446|NCT01615328|Secondary|VAS of Neck Pain(Postoperative 6 Months)|"Evaluation of neck pain using the visual analogue scale (VAS) at 6 months after operation (ACDF).~Reported pain using VAS was recorded and evaluated. Patients were instructed to make a mark on a horizontally-oriented, 10-point VAS labeled no pain (zero point) at the far left and greatest pain (ten point) at the far right."|at 6 months after surgery (ACDF)||||scores on a scale||Standard Deviation|Mean
2656447|NCT01615328|Secondary|VAS of Radiating Pain (Postoperative 6 Months)|"Evaluation of radiating pain using the visual analogue scale (VAS) at 6 months after operation (ACDF).~Reported pain using VAS was recorded and evaluated. Patients were instructed to make a mark on a horizontally-oriented, 10-point VAS labeled no pain (zero point) at the far left and greatest pain (ten point) at the far right."|at 6 months after surgery (ACDF)||||scores on a scale||Standard Deviation|Mean
2656448|NCT01615328|Primary|Bone Fusion With CT(Postoperative 6 Months)|Evaluation of bone fusion between bone substitutes and cervical vertebral endplates with 3-dimensional CT at 6 months after operation (ACDF).|6 months after surgery(ACDF)||||participants|||Number
2656449|NCT01615263|Secondary|Use of Suction to Facilitate Lung Collapse||Up to 5 minutes after surgery||||participants|||Number
2656450|NCT01615263|Secondary|Opinion on the Device|20 minutes after pleural opening, the thoracic surgeon will give his opinion on the lung isolation device that was used on his patient (double lumen tube or bronchial blocker).|20 minutes after pleural opening||||percentage of right guess/opinion|||Number
2656451|NCT01615263|Secondary|Quality of Lung Collapse|"Assessment of lung collapse by the thoracic surgeon at 0, 5, 10 and 20 minutes after pleural opening.Visual analog scale of the quality of lung collapse will be assessed as the following:~No lung collapse~Partial lung collapse, not satisfactory~Partial lung collapse, satisfactory~Complete lung collapse"|From pleural opening to 20 minutes after||||percentage of patients|||Number
2656452|NCT01615263|Primary|Time to Obtain Complete Lung Collapse|For patients intubated with double lumen tube (DLT), clamping of the ipsilateral lumen without continuous positive airway pressure (CPAP) on the isolated lung will be done to allow lung collapse. The timer will be started at this moment and stopped 20 minutes after pleural opening. For patients of the bronchial blocker (BB) group, the first apnea period will of 30 seconds, keeping a pulse oximetry (SpO2) always over 97%, and under direct visualization with the FOB. Afterward, the cuff will be reflated and the timer will be started at this moment and stopped 20 minutes after pleural opening. For both groups, time of total lung collapse will be measured.|From the beginning of one lung ventilation to 20 minutes after pleural opening||||minutes||Standard Deviation|Mean
2656453|NCT01615198|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Death|Adverse event monitoring was conducted throughout the study.|14 weeks|Participants from the safety analysis set were analyzed. The safety analysis set included all randomized participants who received study medication and had post baseline assessments.|||Participants|||Number
2668016|NCT01509677|Secondary|Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (MMP Type 9 (ng/mL))||Baseline to 14 weeks||||ng/mL||Standard Error|Least Squares Mean
2656454|NCT01615198|Secondary|Number of Participants Achieving Successful Response in msSBP and msDBP|Blood pressure response in msSBP was defined as a mean sitting BP < 140 mmHg or a >=20 mmHg reduction from baseline. Blood pressure response in msDBP was defined as a mean sitting diastolic blood pressure, 90 mmHg or >=10 mmHg reduction from baseline.|4 weeks,10 weeks, 14 weeks|Participants from the full analysis set (FAS), who had both baseline and post baseline values at each given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.|||Participants|||Number
2656455|NCT01615198|Secondary|Number of Participants Achieving Overall Blood Pressure Control in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)|A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.|4 weeks, 10 weeks, 14 weeks|Participants from the full analysis set (FAS), who had both baseline and post baseline values at each given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.|||Participants|||Number
2656456|NCT01615198|Secondary|Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) Status in Non-dippers|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of ABPM participants were considered for the analysis. For each post-dosing hour, only participants with values at baseline and the post dosing hour end point were included in the analysis for that end point.|||mmHg||Standard Deviation|Mean
2656457|NCT01615198|Secondary|Change From Baseline in maSBP and maDBP Lowering Based on Nocturnal BP Dipping (Dipper Versus Non-dipper) in Dippers|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A non-dipper was defined as a participant who, at baseline, had a mean nighttime ABPM (10 pm - 6 am) that did not drop ≥ 10% below his or her mean daytime ABPM (6 am - 10 pm). A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of ABPM participants were considered for the analysis. For each post-dosing hour, only participants with values at baseline and the post dosing hour end point were included in the analysis for that end point.|||mmHg||Standard Deviation|Mean
2656458|NCT01615198|Secondary|Change From Baseline in Daytime and Nighttime maSBP/maDBP|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.|||mmHg||Standard Error|Least Squares Mean
2656459|NCT01615198|Secondary|Change From Baseline in Mean Sitting Pulse Pressure|Pulse rate was with automated BP device after the 4th blood pressure measurement at each visit.|Baseline, 4 weeks, 10 weeks, 14 weeks|Participants from the full analysis set (FAS), who had both baseline and post baseline values at the given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.|||mmHg||Standard Error|Least Squares Mean
2656460|NCT01615198|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurements was performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.|Baseline, 10 weeks|Participants from the full analysis set (FAS), who had both baseline and week 10 values, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.|||mmHg||Standard Error|Least Squares Mean
2656461|NCT01615198|Secondary|Change in Baseline in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.|||mmHg||Standard Error|Least Squares Mean
2656462|NCT01615198|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicated improvement.|Baseline, 4 weeks, 14 weeks|Participants from the full analysis set (FAS), who had both baseline and post baseline values at each given time point, were included in the analysis. The FAS included all participants who received study medication and had post baseline BP assessments.|||mmHg||Standard Error|Least Squares Mean
2656463|NCT01615198|Secondary|Change From Baseline in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. Readings were taken every 20 minutes over the 24 hour period in the non-dominant arm. A negative change from baseline indicates improvement.|Baseline, 10 weeks|A subset of participants, who participated in ambulatory blood pressure monitoring, was analyzed.|||mmHg||Standard Error|Least Squares Mean
2656464|NCT01615198|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at trough (immediately prior to dosing at the clinic). At study entry, BP was measured in both arms. The arm with the higher SBP reading was used for the 4 measurements at screening visit and the same arm was used at all subsequent visits. A negative change from baseline indicates improvement.|Baseline, 10 weeks|Only participants, who had both baseline and week 10 values, were included in the analysis. The FAS included all randomized participants who received study medication and had post baseline BP assessments.|||mmHg||Standard Error|Least Squares Mean
2656465|NCT01615029|Secondary|Phase 2: Overall Survival (OS)|Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan Meier method.|Up to 3 years|ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.|||Months||95% Confidence Interval|Median
2656466|NCT01615029|Secondary|Phase 2: Time to Response|Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment.|Up to 3 years|ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.|||Months||Standard Deviation|Mean
2656467|NCT01615029|Secondary|Phase 1: Time to Response|Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment.|Up to 3 years|Responders in all treated population analysis set included.|||Months||Standard Deviation|Mean
2656468|NCT01615029|Secondary|Phase 2: Progression-Free Survival (PFS)|Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first.|Up to 3 years|ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.|||Months||95% Confidence Interval|Median
2656469|NCT01615029|Secondary|Phase 2: Duration of Response|Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the International Myeloma Working Group (IMWG) criteria.|Up to 3 years|Responders in Intent-to-Treat (ITT) population analysis set included.|||Months||95% Confidence Interval|Median
2656470|NCT01615029|Secondary|Phase 2: Time to Progression (TTP)|TTP was defined as the number of days from the date of first infusion (Day 1) to the date of first record of disease progression. Disease progression (IMWG criteria): increase of >=25 percent (%) from lowest response level in Serum M-component and/or (the absolute increase must be >=0.5 g/dL) Urine M-component and/or (the absolute increase must be >=200 mg/24 hour; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL; Bone marrow plasma cell percentage: the absolute % must be >=10 %; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. Median TTP was estimated by using the Kaplan-Meier method.|Up to 3 years|ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.|||Months||95% Confidence Interval|Median
2656471|NCT01615029|Primary|Phase 2: Percentage of Participants With Overall Response Rate (ORR)|ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). IMWG criteria- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; PR: greater than eqaul to (>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percentage (%) or to <200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour.|Up to 3 years|Intent-to-Treat (ITT) population analysis set included all enrolled participants who signed the informed consent during Phase 2.|||Percentage of participants||95% Confidence Interval|Number
2656472|NCT01615029|Primary|Phase 1: Percentage of Participants With Overall Response Rate (ORR)|ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). International Myeloma Working Group (IMWG) criteria- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immuno fluorescence; PR: greater than equal to (>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percentage (%) or to <200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour.|Up to 3 years|All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1.|||Percentage of participants||95% Confidence Interval|Number
2656473|NCT01614912|Secondary|Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)|Proportion of participants with treatment-emergent adverse events. A serious adverse event was defined as an AE that met one or more of the following criteria: Resulted in death; Was life-threatening (i.e., a patient was at immediate risk of death at the time of the event, not an event where occurrence in a more severe form might have caused death); Required hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability or incapacity; Was a congenital anomaly or birth defect; Was an important medical event that might jeopardize the patient or might require medical intervention to prevent one of the outcomes listed above.|EXT baseline and up to 26 weeks|Safety population defined as subjects who receive at least one dose of the study drug.|||Participants|||Count of Participants
2656474|NCT01614912|Secondary|Proportion of Participants With TEAEs Leading to Discontinuation||EXT baseline and up to 26 weeks|Safety population defined as subjects who receive at least one dose of the study drug.|||Participants|||Count of Participants
2656475|NCT01614912|Secondary|Proportion of Participants With Treatment-Emergent Adverse Events (TEAEs)|Proportion of participants with treatment-emergent adverse events. An adverse event was defined as any untoward medical occurrence in a patient treated with a medicinal (investigational) product and which did not necessarily have a causal relationship with this treatment. Treatment-emergent adverse events are defined as adverse events with a start date on or after the date of initial administration of study drug in the present study through the end of follow-up or adverse events occurring before the date of initial administration of study drug in the present study and worsening during the study treatment in the present study.|EXT baseline and up to 26 weeks|Safety population defined as subjects who receive at least one dose of the study drug.|||Participants|||Count of Participants
2656476|NCT01614912|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Score at LOCF Endpoint|The PANSS is comprised of 30 items and three subscales. The General Psychopathology subscale addresses other 16 symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS General Psychopathology subscale score is the sum of all 16 items and ranges from 16 through 112. A higher score is associated with greater illness severity.|DB baseline and up to 32 weeks (LOCF endpoint)|ITT (intent-to-treat) population|||units on a scale||Standard Deviation|Mean
2656477|NCT01614912|Secondary|Change From Baseline in PANSS Negative Subscale Score at LOCF Endpoint|The PANSS is comprised of 30 items and three subscales. The Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS Negative subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.|DB baseline and up to 32 weeks (LOCF endpoint)|ITT (intent-to-treat) population|||units on a scale||Standard Deviation|Mean
2656478|NCT01614912|Secondary|Change From Baseline in PANSS Positive Subscale Score at LOCF Endpoint|The PANSS is comprised of 30 items and three subscales. The Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS Positive subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.|DB baseline and up to 32 weeks (LOCF endpoint)|ITT (intent-to-treat) population|||units on a scale||Standard Deviation|Mean
2656479|NCT01614912|Secondary|Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score at LOCF Endpoint|"CGI-S is a clinician-rated assessment of the participant's current disease state on a 7-point scale, where a higher score is associated with greater severity of the disease.~Baseline in the prior study (D1001056, double-blind [DB] baseline) was defined as baseline of the prior study. Baseline in the present study (D1001057, extension [EXT] baseline) was defined as Week 6 in the prior study.~The last post-baseline visit data collected during the study treatment of the present study were carried forward and defined as the last observation carried forward (LOCF) endpoint."|DB baseline and up to 32 weeks (LOCF endpoint)|ITT (intent-to-treat) population|||units on a scale||Standard Deviation|Mean
2656480|NCT01614912|Primary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at LOCF Endpoint|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and three subscales: the Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|DB baseline and up to 32 weeks (LOCF endpoint)|ITT (intent-to-treat) population|||units on a scale||Standard Deviation|Mean
2656481|NCT01614899|Secondary|Proportion of Participants With Treatment-emergent Serious Adverse Events (SAEs)|Proportion of participants with treatment-emergent adverse events. A serious adverse event was defined as an AE that met one or more of the following criteria: Resulted in death; Was life-threatening (i.e., a patient was at immediate risk of death at the time of the event, not an event where occurrence in a more severe form might have caused death); Required hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability or incapacity; Was a congenital anomaly or birth defect; Was an important medical event that might jeopardize the patient or might require medical intervention to prevent one of the outcomes listed above.|From Baseline to 6 weeks|Safety population defined as subjects who receive at least one dose of the study drug in the treatment phase.|||Participants|||Count of Participants
2656482|NCT01614899|Secondary|Proportion of Participants With TEAEs Leading to Discontinuation||From Baseline to 6 weeks|Safety population defined as subjects who receive at least one dose of the study drug in the treatment phase.|||Participants|||Count of Participants
2656483|NCT01614899|Secondary|Proportion of Participants With Treatment-emergent Adverse Events (TEAEs)|Proportion of participants with treatment-emergent adverse events. An adverse event was defined as any untoward medical occurrence in a patient treated with a medicinal (investigational) product and which did not necessarily have a causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as adverse events with a start date on or after the date of the first dose through the end of follow-up, or adverse events occurring before the date of first dose and worsening during the treatment or follow-up period.|From Baseline to 6 weeks|Safety population defined as subjects who receive at least one dose of the study drug in the treatment phase.|||Participants|||Count of Participants
2656484|NCT01614899|Secondary|Change From Baseline in PANSS General Psychopathology Subscale Scores at Week 6|The PANSS is comprised of 30 items and three subscales. The General Psychopathology subscale addresses other 16 symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS General Psychopathology subscale score is the sum of all 16 items and ranges from 16 through 112. A higher score is associated with greater illness severity.|Baseline and 6 weeks|mITT (modified intent-to-treat) population|||units on a scale||Standard Error|Mean
2656508|NCT01614769|Primary|Recovery Time From Hypoglycemia to Euglycemia|Immediately after release of the hypoglycemic clamp, which maintained blood glucose close to 50 mg/dL, the time taken until glucose reached euglycemia, defined as 3 consecutive measurements >= 70 mg/dL, is called the recovery time.|From 1 to 180 minutes post hypoglycemic clamp|The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period.|||Minutes||90% Confidence Interval|Least Squares Mean
2656485|NCT01614899|Secondary|Change From Baseline in PANSS Negative Subscale Scores at Week 6|The PANSS is comprised of 30 items and three subscales. The Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS Negative subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.|Baseline and 6 weeks|mITT (modified intent-to-treat) population|||units on a scale||Standard Deviation|Mean
2656486|NCT01614899|Secondary|Change From Baseline in PANSS Positive Subscale Scores at Week 6|The PANSS is comprised of 30 items and three subscales. The Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS Positive subscale score is the sum of all 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.|Baseline and 6 weeks|mITT (modified intent-to-treat) population|||units on a scale||Standard Deviation|Mean
2656487|NCT01614899|Secondary|Change From Baseline in the Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 6|"CGI-S is a clinician-rated assessment of the participant's current disease state on a 7-point scale, where a higher score is associated with greater severity of the disease.~The change from baseline in CGI-S score (repeated measures) at each visit during the treatment phase is presented for the mITT population"|Baseline and 6 weeks|mITT (modified intent-to-treat) population|||units on a scale||Standard Deviation|Mean
2656488|NCT01614899|Primary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and three subscales: the Positive subscale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative subscale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|Baseline and 6 week|mITT (modified intent-to-treat) population|||units on a scale||Standard Deviation|Mean
2656489|NCT01614886|Secondary|The Percentage of Treatment Retention.|Treatment retention rate at effective dose is defined as the proportion of patients who met all the followings - 1) completed the study, 2) received rivastigmine patch 18 mg/day throughout the last 8 weeks 3) received 18 mg/day for ≥75% of the days during the last 8 weeks|Up to 24 weeks|Safety population (SAF) This population consisted of all randomized patients who received at least one dose of study medication and had at least one safety assessment after baseline. Patients were analyzed according to the treatment group they were assigned to at randomization.|||Percentage of Participants|||Number
2656490|NCT01614886|Secondary|"Number of Participants With Improvement in Japanese Clinical Global Impression of Change (J-CGIC). Patients With Improvement: a Total of 1. Markedly Improved, 2. Improved, and 3. Slightly"|The J-CGIC is simple 7 grade investigator's impression scale (1. Markedly improved, 2. Improved, 3. Slightly improved, 4. No change, 5. Slightly aggravated, 6. Aggravated, 7. Markedly aggravated) and a patient is defined to have improvement if J-CGIC tool the values 1, 2, or 3.|4, 8, 12,16, 20 and 24 weeks|Full analysis set (FAS): The FAS includes all randomized patients who received at least one dose of study drug and had at least one pre- and post-baseline assessment for any of the efficacy variables. n is the number of patients with an assessment at baseline and the corresponding visit.|||Participants|||Number
2656491|NCT01614886|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE)|The MMSE was used to measure severity of Alzheimer's disease. The test consists of 2 parts: language (time orientation, registration and attention) and performance (recall, response to written/verbal commands, sriting ability and reproduction of complex polygons); the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.|Baseline and 24 weeks|Full analysis set (FAS): The FAS includes all randomized patients who received at least one dose of study drug and had at least one pre- and post-baseline assessment for any of the efficacy variables. n is the number of patients with an assessment at baseline and the corresponding visit.|||Units on a scale||Standard Deviation|Mean
2656492|NCT01614886|Secondary|Change From Baseline in the Alzheimer's Disease Assessment Scale - Japan Cognitive Subscale (ADAS-J Cog)|The Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) was used to measure change in cognitive function. The ADAS-J cog score ranges from 0-70, with higher total scores indicating more impairment. A negative change score indicates improvement from baseline.|Baseline, 8,16, and 24 weeks|Full analysis set (FAS): includes all randomized patients who received at least one dose of study drug and had at least one pre- and post-baseline assessment for any of the efficacy variables. n is the number of patients with an assessment at baseline and the corresponding visit.|||Units on a scale||Standard Deviation|Mean
2656493|NCT01614886|Primary|Percentage of Patients With Adverse Events Leading to Study Drug Discontinuation|The primary variable of this study is the percentage of patients having an AE leading to study drug discontinuation during the 24-week double-blind treatment period.|Up to 24 weeks|Safety population (SAF) This population consisted of all randomized patients who received at least one dose of study medication and had at least one safety assessment after baseline.|||Percentage of participants|||Number
2656523|NCT01614574|Primary|Development of Anti-velaglucerase Alfa Antibody||Baseline to week51||||participants|||Number
2656524|NCT01614574|Primary|Number of Treatment Emergent Adverse Events (TEAE)||Baseline to week 51||||events|||Number
2656525|NCT01614574|Primary|Number of Severe Adverse Events (SAE)||Baseline to week 51||||events|||Number
2656526|NCT01614509|Primary|Changes of Central Retinal Thickness|Changes of central retinal thickness on optical coherence tomography (OCT) at baseline and 1, 3, 6 month after injection|baseline, 1, 3, 6 months after injection|Participants who were finished 6 months follow up period.|||micrometer||Standard Deviation|Mean
2656494|NCT01614847|Primary|Osmolarity Change From Baseline (mOsms/L) as a Function of Time (Minutes)|Raw data: Baseline (pre-instillation) tear osmolarity was measured for right and left eyes for each subject. Then measurements were repeated at 7 times (5, 20, 35, 50, 65 890 and 95 minutes) after instillation. Data processing: 1) Baseline osmolarity was subtracted from each post-baseline measurement to give a change-from-baseline values. 2) Right and left eye change values averaged to give a mean osmolarity change for each subject at each of the seven times. 3) Mean osmolarity changes values were averaged across 8 subjects for each of the 7 times and entered in the table below. Row 1 is for Drop A (hyaluronate); Row 2 for Drop B (saline). Column are for the 7 times.|Baseline, followed by 7 measurements made after instillation (5, 20, 35, 50, 65, 80, 95 minutes post-instillation).|Eight subjects recruited from among students at the NSU Oklahoma College of Optometry, including 6 males and 2 females who were at least 18 years of age and who had no known ocular or systemic disease other than dry eye. Six subjects did not have dry eye and 2 were diagnosed with dry eye based on Ocular Surface Disease Index (OSDI) survey scores.|||mOsmols/L|Eyes|Standard Error|Mean
2656495|NCT01614821|Secondary|Very Good Partial Response Rate|To assess the very good partial response rate (>90% reduction in serum IgM from baseline)|4 years||||Participants|||Count of Participants
2656496|NCT01614821|Secondary|Major Response Rates|To assess the major response rate (>50% reduction in serum IgM from baseline)|4 years||||Participants|||Count of Participants
2656497|NCT01614821|Secondary|To Determine Time to Next Therapy (TTNT) of PCI-32765 in Symptomatic WM Patients With Relapsed/Refractory Disease|Time to Next Therapy is the duration of time from of starting ibrutinib until next therapy. Participants were treated for 40 cycles and then followed for 2 years or until next therapy or death. Participants had the option to continue ibrutinib commercially. 40 participants were censored while still on commercial ibrutinib therapy.|6 years||||months||Full Range|Median
2656498|NCT01614821|Secondary|Determine Progression Free Survival|To determine Progression Free Survival (PFS in symptomatic WM patients with relapsed/refractory disease. Participants were treated for 40 cycles and then followed for 2 years or until next therapy or death. 40 participants were censored prior to disease progression.|6 years||||months||Full Range|Median
2656499|NCT01614821|Secondary|Safety and Tolerability of PCI-32765|To assess the safety and tolerability of PCI-32765 in symptomatic WM patients with relapsed/refractory disease. Grade > or = 2 Adverse Events determined to be associated with PCI-32765 and subsequent outcomes will constitute the safety profile of PCI-32765 in WM. Percent of participants who experienced at least 1 grade 2 or higher treatment emergent adverse event.|4 years||||Participants|||Count of Participants
2656500|NCT01614821|Primary|Overall Response Rate|To assess the overall response rate (>25% reduction in serum IgM from baseline).|4 years||||Participants|||Count of Participants
2656501|NCT01614795|Secondary|Number of Patients With Detectable Bone Marrow Micrometastatic Disease Estimated as the Proportion of Eligible Patients Entered Into the Ewing Sarcoma Stratum Who Have Detectable Tumor Cells in the Marrow at Enrollment||Baseline|2 patients of the 12 patients enrolled in the Ewing Sarcoma stratum submitted specimens for analysis|||Participants|||Count of Participants
2656502|NCT01614795|Secondary|Expression Levels of IGF-1R, Insulin Receptor, ERK, RON, and mTOR|Number of patients expressing insulin-like growth factor 1 receptor (IGF-1R), insulin receptor, ERK, RON, and mammalian target of rapamycin (mTOR) at levels 0, 1+, 2+, 3+ by immunohistochemistry.|Baseline|All specimens for the IHC analysis for IGF-1R, Insulin Receptor, ERK, RON, and mTOR were obtained prior to the start of treatment on ADVL1221. Levels 0, 1+, 2+ and 3+ represent increasing strengths of IHC staining.|||Participants|||Count of Participants
2656503|NCT01614795|Secondary|Progression-free Interval|Percentage Probability of remaining progression-free 5 years after enrollment estimated by the method of Kaplan and Meier|10 months after enrollment|The 10 month time point was chosen since the shortest follow-up available was observed in Group 3 (relapsed or refractory rhabdomyosarcoma) where the last patient under observation was censored after completing 10 months of follow-up|||percent probability||95% Confidence Interval|Number
2656504|NCT01614795|Primary|Number of Cycles of Toxicity|The number of patients-cycles where CTC Version 4 grade 3 or higher increased Alanine aminotransferase was observed|Duration of protocol therapy - Up to 25 cycles (700 days)|One hundred six (106) cycles were reported for the analysis of this toxicity|||cycles|cycles||Number
2656505|NCT01614795|Primary|Objective Response Rate (PR or CR) by Response Evaluation Criteria in Solid Tumors (RECIST).|Per Response evaluation criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall Response (OR)= CR+PR. The combination of sufficient activity is considered if the true response rate is 35% or greater.|6 cycles (168 days)|One (1) of the patients in Group 1 and one (1) of the patients in Group 4 were considered inevaluable for response assessment. One (1) of the patients in Group 2 was ineligible.|||participants|||Number
2656506|NCT01614769|Primary|Incremental Weighted Average Blood Glucose Concentration Over 3 Hours of Hypoglycemic Recovery|The incremental weighted average qualitatively assesses overall hypoglycemic recovery by measuring mean glycemia over the 3 hour recovery period. Blood glucose measured at the release of the hypoglycemic clamp, considered the baseline value, was subtracted from blood glucose values measured over the ensuing 3 hours of hypoglycemic recovery. These differences from baseline were averaged to calculate the incremental weighted average blood glucose concentration.|From 1 to 180 minutes post hypoglycemic clamp|The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period.|||mg/dL||90% Confidence Interval|Least Squares Mean
2656507|NCT01614769|Primary|Rate of Recovery From Hypoglycemia to Euglycemia|The rate of recovery is the difference in concentration between blood glucose at euglycemia and at the end of the hypoglycemic clamp, divided by the recovery time.|From 1 to 180 minutes post hypoglycemic clamp|The per-protocol population consisting of participants who received drug and completed the necessary post treatment measurements for at least one treatment period.|||mg/dL/minute||90% Confidence Interval|Least Squares Mean
2656707|NCT01612221|Secondary|Transcriptional Markers of UV-induced Oxidative Stress in Nevi|Biomarkers susceptible to UV-induced damage protected by NAC (N-acetylcysteine) in irradiated and unirradiated nevi|3.5 years|One subject with low-risk MC1R randomized to drug was excluded because the lesions removed were seborrheic keratoses and not nevi.|||markers of UV-induced oxidative stress||Standard Deviation|Mean
2656509|NCT01614613|Secondary|Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements|Subjects responded to statements about meter accuracy and diabetes management. Subject responses: 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'or No Response. □1ACCURACY HELPS 1A-with my ability to talk with my HCP. 1B-my satisfaction with my self monitoring of diabetes. 1C-with my ability to manage my diabetes. 1D-prevent low BG. 1E-understand how food/exercise affects low BG. □2 I WOULD USE ONLY the meter and strips my insurance company pays for, even if a more accurate meter was available. □3 I USE MY CURRENT METER BECAUSE 3A-my HCP gave it to me. 3B-my insurance company covers the strips. 3C-I think it is the most accurate meter. □4 I WOULD SWITCH meters for a more accurate meter. □5BEING ABLE TO APPLY MORE BLOOD IS IMPORTANT 5A-as I have wasted test strips by not having enough blood to fill the strip 5B-as this would save test strips 5C-I would switch to a meter with this feature|1 hour|Since subjects had the option to provide No Response at all to a question, some questionnaire statements had less than 146 participant responses possible (see numbers in parentheses)|||participants|||Number
2656510|NCT01614613|Secondary|Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL)|Variability of each meter system was determined by calculating the Standard Deviation derived from each meter's differences between Blood Glucose Meter (BGMS)results and corresponding YSI Blood Glucose (BG) results.|6 hours|Same numbers (538) of BG results were possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided 438 unmodified capillary samples and 100 samples were modified (21 to 496 mg/dL).|||Standard Deviation|Participants||Number
2656511|NCT01614613|Secondary|MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL|"Using samples with BG >180 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values was compared. MAD was calculated from the sum of all |(BG meter)-(BG reference)| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value."|6 hours|Same number (231) of BG results was possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided 181 unmodified capillary samples >180 mg/dL and 50 samples were modified by adding glucose solution.|||mg/dL|Participants|Standard Error|Least Squares Mean
2656512|NCT01614613|Secondary|MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL|"Using samples with BG 70 mg/dL to 180 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values were compared. MAD was calculated from the sum of all|(BG meter)-(BG reference)| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value."|6 hours|Same number (172) of BG results was possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided all 172 capillary samples (70 to 180 mg/dL) and no samples were modified.|||mg/dL|Participants|Standard Error|Least Squares Mean
2656513|NCT01614613|Primary|MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL)|"Using samples with BG < 70 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values were compared. MAD was calculated from the sum of all |(BG meter)-(BG reference)| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value."|6 hours|Same number (135) of BG results was possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided 85 unmodified capillary samples <70 mg/dL and 50 samples were modified by glycolyzing them.|||mg/dL|Participants|Standard Error|Least Squares Mean
2656514|NCT01614600|Primary|Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2|Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye.|Baseline, Week 1, Week 2|Per Protocol: All enrolled and dispensed participants, minus any major protocol deviators as determined by masked review.|||Units on a scale||Standard Deviation|Mean
2656515|NCT01614574|Secondary|Change From Baseline in CCL18 Levels||Baseline to week 51||||(ng/mL)||Standard Deviation|Mean
2656516|NCT01614574|Secondary|Change From Baseline in Plasma Chitotriosidase Levels||Baseline to week 51||||(nmol/mL/h)||Standard Deviation|Mean
2656517|NCT01614574|Secondary|Change From Baseline in Spleen Volume, Normalized to Body Weight||Baseline to week 51||||(% of Body Weight)||Standard Deviation|Mean
2656518|NCT01614574|Secondary|Change From Baseline in Liver Volume, Normalized to Body Weight||Baseline to week 51||||(% of Body Weight)||Standard Deviation|Mean
2656519|NCT01614574|Secondary|Change From Baseline in Platelet Count||Baseline to week 51||||(x 10`{super 9}/L)||Standard Deviation|Mean
2656520|NCT01614574|Secondary|Change From Baseline in Hemoglobin Concentration||Baseline to week 51||||(g/dL)||Standard Deviation|Mean
2656521|NCT01614574|Primary|Number of Patients With Concomitant Medication||Baseline to week 51||||participants|||Number
2656522|NCT01614574|Primary|Number of Infusion- Related Adverse Events||Baseline to week 51||||events|||Number
2656527|NCT01614509|Secondary|Additional Intravitreal Bevacizumab Injection|Comparison of the additional intravitreal bevacizumab injection of intravitreal bevacizumab monotherapy or combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab during 6 months|6 months|We evaluated mean times of additional intravitreal injection because of recurrent macular edema within participants who who were finished 6 months follow up periods.|||times of injection||Standard Deviation|Mean
2656528|NCT01614470|Secondary|Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any adverse change from subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.|Part 2: Week 20 up to Week 40|Safety Set for Part 2 included all subjects who received at least 1 dose of study drug (ivacaftor).|||participants|||Number
2656529|NCT01614470|Secondary|Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any adverse change from subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording/clinical laboratory assessment which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.|Part 1: From signing of informed consent up to Week 20|Safety Set for Part 1 included all subjects who received at least 1 dose of study drug (ivacaftor or placebo).|||participants|||Number
2656530|NCT01614470|Secondary|Part 2: Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through 24 Weeks of Treatment (Week 36 Visit)|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Change in CFQ-R respiratory domain score over 24 weeks of ivacaftor treatment (from Week 12 [Part 1: Treatment Period 2] through Week 36 [Part 2]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2 as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.|Baseline (pre-dose Week 12), Week 36|FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure.|||units on a scale||Standard Deviation|Mean
2656531|NCT01614470|Secondary|Part 1: Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 8|The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.|Part 1: Baseline (pre-dose Day 1), Week 8|"FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, n signifies those subjects who were evaluable for this measure at given time point for each group, respectively."|||units on a scale||Standard Deviation|Mean
2656532|NCT01614470|Secondary|Part 2: Change From Baseline in Sweat Chloride Through 24 Weeks of Treatment (Week 36 Visit)|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Change in sweat chloride over 24 weeks of ivacaftor treatment (from Week 12 [Part 1: Treatment Period 2] through Week 36 [Part 2]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2 as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.|Baseline (pre-dose Week 12), Week 36|"FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure. Here n signifies those subjects who were evaluable for this measure at given time point."|||mmol/L||Standard Deviation|Mean
2656533|NCT01614470|Primary|Part 2: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through 24 Weeks of Treatment (Week 36 Visit)|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 6 to 17 years and for female subjects aged 6 to 15 years. Absolute change in percent predicted FEV1 over 24 weeks of ivacaftor treatment (from Week 12 [Part 1: Treatment Period 2] through Week 36 [Part 2]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2, as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.|Baseline (pre-dose Week 12), Week 36|FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure.|||percent predicted of FEV1||Standard Deviation|Mean
2656534|NCT01614470|Secondary|Part 1: Change From Baseline in Sweat Chloride Through Week 8|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.|Part 1: Baseline (pre-dose Day 1), Week 8|"FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, n signifies those subjects who were evaluable for this measure at given time point for each group, respectively."|||millimole per liter (mmol/L)||Standard Deviation|Mean
2656535|NCT01614470|Secondary|Part 2: Change From Baseline in Body Mass Index (BMI) at 24 Weeks of Treatment (Week 36 Visit)|BMI was defined as weight in kg divided by height in m^2. Change in BMI over 24 weeks of ivacaftor treatment (from Week 12 [Part 1: Treatment Period 2] through Week 36 [Part 2]) was reported for subjects who received ivacaftor in Part 1: Treatment Period 2 as per planned analysis. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during Part 1: Treatment Period 2.|Baseline (pre-dose Week 12), Week 36|FAS for Part 2: all randomized subjects who received at least 1 dose of study drug (ivacaftor). Only subjects who were randomized to receive ivacaftor during Part 1: Treatment Period 2 were to be analyzed for this measure.|||kg/m^2||Standard Deviation|Mean
2656536|NCT01614470|Secondary|Part 1: Change From Baseline in Body Mass Index (BMI) at Week 8|BMI was defined as weight in kilogram (kg) divided by height in meters^2 (m^2). Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.|Part 1: Baseline (pre-dose Day 1), Week 8|"FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, n signifies those subjects who were evaluable for this measure at given time point for each group, respectively."|||kg/m^2||Standard Deviation|Mean
2656537|NCT01614470|Primary|Part 1: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 8|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 6 to 17 years and for female subjects aged 6 to 15 years. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug during study Part 1.|Part 1: Baseline (pre-dose Day 1), Week 8|"FAS for Part 1: all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, n signifies those subjects who were evaluable for this measure at given time point for each group, respectively."|||percent predicted of FEV1||Standard Deviation|Mean
2656538|NCT01614457|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence, including clinically significant clinical laboratory assessments which occurs during course of study, whether it is considered related to study drug or not. SAE: medical event or condition, which falls into any of following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event.|Baseline up to follow-up (3 to 4 weeks after last dose [last dose = Week 24])|Safety Set included all subjects who received at least 1 dose of study drug (ivacaftor or placebo).|||participants|||Number
2656539|NCT01614457|Secondary|Time to First Pulmonary Exacerbation|Number of events (pulmonary exacerbation) during the pre-specified time intervals were reported. A subject without an exacerbation before withdrawal from the study was considered censored at the time of withdrawal, and a subject without an exacerbation who completes the study period was considered censored at the end of the analysis period.|Day 0 to 15, Day 16 to 56, Day 57 to 112, Day 113 to 168|FAS included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).|||events|||Number
2656540|NCT01614457|Secondary|Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 24|The CFQ-R is a validated subject-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life|Baseline, Week 24|"FAS included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, Number of participants analyzed signifies those subjects who were evaluable for this measure."|||units on a scale||Standard Error|Least Squares Mean
2656541|NCT01614457|Secondary|Change From Baseline in Sweat Chloride Through Week 24|Sweat samples were collected using an approved Macroduct (Wescor, Logan, Utah) collection device. A volume of greater than or equal to (>=) 15 microliter was required for determination of sweat chloride.|Baseline, Week 24|"FAS included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo). Here, Number of participants analyzed signifies those subjects who were evaluable for this measure."|||millimole per liter (mmol/L)||Standard Error|Least Squares Mean
2656542|NCT01614457|Secondary|Change From Baseline in Body Mass Index (BMI) at Week 24|BMI was defined as weight in kilogram (kg) divided by height in square meter (m^2).|Baseline, Week 24|FAS included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).|||kg/m^2||Standard Error|Least Squares Mean
2656543|NCT01614457|Primary|Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Hankinson and Wang standards were used to calculate percent predicted FEV1 (for age, gender, and height). The Hankinson standard was used for male subjects 18 years and older and female subjects 16 years and older. The Wang standard was used for male subjects aged 6 to 17 years and for female subjects aged 6 to 15 years.|Baseline, Week 24|Full Analysis Set (FAS) included all randomized subjects who received at least 1 dose of study drug (ivacaftor or placebo).|||percent predicted of FEV1||Standard Error|Least Squares Mean
2656544|NCT01614392|Primary|Leg Extensor Muscle Power|Leg extensor muscle power measured on pneumatic strength testing equipment at a external force consistent with 70% of the participant maximum leg extensor strength.|Change from baseline to Week 16|4 participants dropped out of study before follow up|||Watts||Standard Error|Mean
2656555|NCT01613768|Secondary|Duration of Tumor Response (Complete (CR) and Partial (PR) Response Only)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR, reported as median values.|From date of first study therapy until date of first documented disease progression or date of death from any cause, unacceptable toxicity or withdrawal of patient consent, whichever occurred first, assessed up to 36 days post last dose of study therapy.|Participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline who achieved a CR or PR per RECIST 1.1.|||weeks||Full Range|Median
2656545|NCT01614249|Primary|Change in BDI-II Depressive Symptom Scores|Depressive symptoms were assessed by Beck Depression Inventory Second Edition (BDI-II) Scoring scale at Baseline and end of study during the 8- week study period. The BDI-II Scale is a 21-item scoring tool which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe).Scores for each symptom are added up to obtain the total scores for all 21 items, which are interpreted as follows: Scores of 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression and 29-63: severe depression. The change in BDI-II scores were computed from post-intervention scores at week 8 and baseline BDI-II scores at week 0.|8 weeks|Only participants who completed the 8-weeks trial period were included in the final analysis of primary outcome. Per protocol analysis Post-intervention BDI-II scores at week 8 minus baseline BDI-II scores at week 0|||scores on BDI-II scale||95% Confidence Interval|Mean
2656546|NCT01614210|Other Pre-specified|Change in FACT-ES Symptom Scores|Patients were given the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) quality of life assessment at baseline (prior to tamoxifen administration) and again 7 days following start of tamoxifen to assess quality of life while on tamoxifen. The difference in total score from baseline to 7 days was calculated. The FACT-ES total score ranges from 0-180, with higher scores indicating higher quality of life.|7 days|Of the 50 patients enrolled, 46 had both pre and post FACT-ES total scores.|||change in units on a scale||Full Range|Median
2656547|NCT01614210|Secondary|Correlation Between Changes in Ki67 and Symptoms|Evaluate correlation between changes in Ki67 expression and symptom scores. Differences between changes in FACT-ES total score were correlated with changes in Ki67 expression using a the Spearman correlation method and results are expressed as the correlation coefficient.|7 days|Of the 50 patients enrolled Ki67 measurements were obtained for 44. Of the 44 patients which had a Ki67 result, 43 had both a pre and post symptom score.|||spearman correlation coefficient|||Number
2656548|NCT01614210|Secondary|Number of Participants With Long Term Endocrine Therapy Adherence|For the patient population on this study, endocrine therapy was indicated for 5 years post-surgery according to the current standard of care recommendations for hormone positive breast cancer. Endocrine therapy was prescribed as standard of care as appropriate for each patient's situation. At 18 months post-surgery, patients were evaluated to determine if they were taking their endocrine therapy as prescribed.|18 months|Of the 52 patients enrolled on the study, 38 patients had data regarding long term endocrine therapy at 18 months post-surgery.|||participants adhering to therapy|||Number
2656549|NCT01614210|Secondary|Change in FACT-ES Symptom Scores|Patients were given the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) quality of life assessment at baseline (prior to tamoxifen administration) and again 18 months following breast surgery to assess quality of life. The difference in total score from baseline to 18 months was calculated. The FACT-ES total score ranges from 0-180, with higher scores indicating higher quality of life.|18 months|Of the 44 patients evaluable for the primary outcome measure, 35 completed both baseline and 18 month FACT-ES assessments|||change in units on a scale||95% Confidence Interval|Mean
2656550|NCT01614210|Primary|Change in Ki67 Expression in Tumors|Demonstrate a significant change in Ki67 expression in tumors with 7 days of pre-surgical tamoxifen.|7 days|3 were not evaluable due to rescheduling of surgery; 1 not evaluable due to pharmacy error. 2 patients had no invasive tumor on Ki-67 slides from pretreatment biopsy, and 2 patients had no invasive tumor on post-treatment surgery and were not evaluable.|||percentage change in Ki67||95% Confidence Interval|Mean
2656551|NCT01614093|Primary|Food Consumption After Intervention|"We hypothesize that participants will have greater satiety signaling, indicated by less consumption of the Test Meal consumed 90 minutes after the preload."|90 minutes||||Grams||Standard Deviation|Mean
2656552|NCT01613768|Secondary|Toxicity Rates|Overall percentage of patients experiencing Grade 3 or higher toxicity, graded by National Cancer Institute (NCI) Common Toxicity Criteria Version 4.0|Adverse events collected from the time patient received the first dose of study therapy through 36 days following the last dose of study therapy or the start of a new cancer therapy, whichever occurred first, assessed up to 36 days post therapy.||||Participants|||Count of Participants
2656553|NCT01613768|Secondary|Disease Control Rate (DCR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage (compared to baseline) to qualify for partial or complete response (CR or PR) nor sufficient increase (taking as reference the smallest sum of diameters at baseline or while on study, whichever is smallest) to qualify for progressive disease (PD); Disease Control Rate (DCR) = CR + PR +SD.|From date of first study therapy until date of first documented disease progression or date of death from any cause, unacceptable toxicity or withdrawal of patient consent, whichever occurred first, assessed up to 36 days post last dose of study therapy.|All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline.|||Participants|||Count of Participants
2656554|NCT01613768|Secondary|Time to Progression|Either 1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Progressive Disease (PD), > 20% increase in the sum of the longest diameter (SLD) target lesions taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 mm increase over the nadir; or 2. Radiographic progression per treating physician CT or MRI scan review.|From date of first study therapy until date of first documented disease progression or date of death from any cause, whichever occurred first, assessed up to 36 days post last dose of study therapy.|All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline. Does not include 7 patients taken off study before radiological progression: Toxicity = 3, Clinical PD = 4.|||Weeks||Full Range|Median
2656579|NCT01613378|Secondary|Percentage of Participants With Changes in Extra-Articular Manifestations at 12 Months|The extra-articular RA manifestations ascertained were the nodules, Raynaud's phenomenon, secondary Sjogren's syndrome, pulmonary fibrosis, pericarditis, polyneuropathy, scleritis, severe cutaneous vasculitis, weight loss and anemia. Percentages are based on the total number of participants with available data.|At 12 months|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the assessment of Extra-Articular Manifestations were included in this analysis.|||percentage of participants|||Number
2656556|NCT01613768|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by either CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR, summarized using frequencies and percentages.|From date of first study therapy until date of first documented disease progression or date of death from any cause, unacceptable toxicity or withdrawal of patient consent, whichever occurred first, assessed up to 36 days post last dose of study therapy.|All participants receiving at least 1 dose of study intervention and at least 1 assessment post-baseline.|||Participants|||Count of Participants
2656557|NCT01613716|Primary|Visual Acuity|ETDRS visual acuity will be measured at 3 months. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning.|3 months|23 of the participants were able to come in for their 3 month appointment per protocol|||ETDRS||Full Range|Median
2656558|NCT01613716|Primary|Central Retinal Thickness|At 3 months, central retinal thickness as measured by optical coherence tomography will be measured|3 months|Optical Coherence Tomography was collected at 3 months. 22 of the patients were seen at month 3.|||micrometers||Full Range|Median
2656559|NCT01613599|Secondary|Incidence Rate of Serious Infections in Participants Who Received Re-treatment With MabThera/Rituximab|A serious infection was defined as an infection that was a serious adverse event (SAE) or a non-SAE infection that required treatment with intravenous antimicrobials. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was medically significant or required intervention to prevent one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)|The re-treated safety population was a subset of the safety population and included all participants who received more than one course of rituximab.|||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
2656560|NCT01613599|Secondary|Incidence Rate of Serious Adverse Events in Participants Who Received Re-treatment With MabThera/Rituximab|A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was medically significant or required intervention to prevent one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)|The re-treated safety population was a subset of the safety population and included all participants who received more than one course of rituximab.|||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
2656561|NCT01613599|Secondary|Incidence Rate of Adverse Events With Fatal Outcomes|Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)|The safety population included all participants who received any active dose of rituximab.|||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
2656562|NCT01613599|Secondary|Incidence Rate of Serious Adverse Events|A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was medically significant or required intervention to prevent one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)|The safety population included all participants who received any active dose of rituximab.|||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
2656563|NCT01613599|Secondary|Incidence Rate of Malignancy, Excluding Non-melanoma Skin Cancer|Malignancies were clinical findings of cancer and excluded non-melanoma skin cancer. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)|The safety population included all participants who received any active dose of rituximab.|||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
2656564|NCT01613599|Secondary|Incidence Rate of Serious Vascular Adverse Events|A serious vascular adverse event was defined as a SAE coded to the MedDRA vascular system organ class. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was medically significant or required intervention to prevent one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)|The safety population included all participants who received any active dose of rituximab.|||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
2656565|NCT01613599|Secondary|Percentage of Participants With Any Serious Adverse Events During or Within 24 Hours After Any Rituximab Infusion|A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was medically significant or required intervention to prevent one or other of the outcomes listed above.|From the start of an infusion up to 24 hours following infusion completion (Up to 4.32 years)|The safety population included all participants who received any active dose of rituximab.|||percentage of participants|||Number
2656566|NCT01613599|Secondary|Incidence Rate of Serious Cardiac Adverse Events|A serious cardiac adverse event was defined as a SAE that was coded to the Medical Dictionary for Regulatory Activities (MedDRA) cardiac system organ class. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was medically significant or required intervention to prevent one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)|The safety population included all participants who received any active dose of rituximab.|||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
2656567|NCT01613599|Secondary|Percentage of Participants With a Serious Infusion-related Reaction|A serious infusion-related reaction was defined as a SAE during or within 24 hours after any rituximab infusion and considered infusion related by the Principal Investigator. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was medically significant or required intervention to prevent one or other of the outcomes listed above.|From the start of an infusion up to 24 hours following infusion completion (Up to 4.32 years)|The safety population included all participants who received any active dose of rituximab.|||percentage of participants|||Number
2656568|NCT01613599|Primary|Incidence Rate of Serious Infections|A serious infection was defined as an infection that was a serious adverse event (SAE) or a non-SAE infection that required treatment with intravenous antimicrobials. A SAE was defined as any adverse event that fulfilled at least one of the following criteria: •Was fatal (results in death) •Was life-threatening •Required in-patient hospitalization or prolongation of existing hospitalization •Resulted in persistent or significant disability/incapacity •Was a congenital anomaly/birth defect •Was medically significant or required intervention to prevent one or other of the outcomes listed above. Multiple events reported in the same participant were counted multiple times in the calculation of incidence. Incidence rate is defined as events per 100 patient years.|From first dose until participant withdrawal or the date of last participant, last visit (up to 4.32 years)|The safety population included all participants who received any active dose of rituximab.|||events per 100 patient year|Total Patient-years at Risk|95% Confidence Interval|Number
2656569|NCT01613417|Secondary|Accuracy for Tumor Characterization|Blinded reader assessment of accuracy of tumor characterization (benign/malignant) - patient level assessment|5-10 minutes Postdose|Subjects with histologically confirmed lesions|||participants|||Number
2656570|NCT01613417|Secondary|Lesion Detection|Lesion detection rate by contrast agent and reader|5-10 minutes Postdose|Per protocol patients with histologically confirmed lesions|||participant exams|||Number
2656571|NCT01613417|Secondary|Percentage Signal Intensity Enhancement on Postdose Images|Mean difference in percentage signal intensity enhancement on postdose T1-weighted SE/FSE images (ProHance - Gadovist/Gadavist)|5-10 minutes Postdose|Per-protocol population|||percentage signal intensity enhancement|Participants|Standard Deviation|Mean
2656572|NCT01613417|Secondary|Lesion to Background Ratio on Post T1-weighed Spin Echo Images|Mean of difference in signal intensity postdose (ProHance - Gadovist/Gadavist)|5-10 minutes Postdose|Per-protocol population|||signal intensity|Participants|Standard Deviation|Mean
2656573|NCT01613417|Secondary|Lesion Contrast Enhancement|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days||||participant exams|Participants||Number
2656574|NCT01613417|Secondary|Extent of Disease|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days||||participant exams|Participants||Number
2656575|NCT01613417|Secondary|Lesion Internal Morphology|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days||||participant exams|Participants||Number
2656576|NCT01613417|Secondary|Lesion Border Delineation|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days||||participant exams|Participants||Number
2656577|NCT01613417|Primary|Global Diagnostic Preference Between the Two Exams|Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.|Comparison of image sets obtained within 2 to 14 days|Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations|||participant exams|Participants||Number
2656578|NCT01613378|Secondary|Number of Participants With Changes in Severity of Extra-Articular Manifestations at 12 Months|"The severity of extra-articular RA manifestations ascertained were the nodules, Raynaud's phenomenon, secondary Sjogren's syndrome, pulmonary fibrosis, pericarditis, polyneuropathy, scleritis, severe cutaneous vasculitis, weight loss and anemia. Percentages are based on the total number of participants who responded YES to changes in extra- articular RA manifestations (new presence or change in severity) since the last visit. NA=Not applicable"|At 12 months|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the assessment of Extra-Articular Manifestations were included in this analysis.|||participants|||Number
2656580|NCT01613378|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|The erythrocyte sedimentation rate (ESR) was analyzed at the site using the kit provided by the central laboratory. A reduction in the level of ESR was considered an improvement.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the ESR assessment were included in this analysis.|||mm/hr||Standard Deviation|Mean
2656581|NCT01613378|Secondary|Change From Baseline in C-Reactive Protein (CRP)|The serum concentration of C-reactive protein (CRP) was measured. A reduction in the level of CRP was considered an improvement.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the CRP assessment were included in this analysis.|||mg/L||Standard Deviation|Mean
2656582|NCT01613378|Secondary|Change From Baseline in Patient Assessment of Fatigue (Visual Analog Scale, VAS)|With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of fatigue.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Patient Assessment of Fatigue on the VAS were included in this analysis.|||units on a scale||Standard Deviation|Mean
2656583|NCT01613378|Secondary|Change From Baseline in Patient Assessment of Pain (Visual Analog Scale, VAS)|With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of pain.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Assessment of Pain on the VAS were included in this analysis.|||units on a scale||Standard Deviation|Mean
2656584|NCT01613378|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity (Visual Analog Scale, VAS)|With VAS, physicians specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of disease activity.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Assessment of Disease Activity on the VAS were included in this analysis.|||units on a scale||Standard Deviation|Mean
2656585|NCT01613378|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity (Visual Analog Scale, VAS)|With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of disease activity.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Assessment of Disease Activity on the VAS were included in this analysis.|||units on a scale||Standard Deviation|Mean
2656586|NCT01613378|Secondary|Change From Baseline in Duration of Morning Stiffness (Visual Analog Scale, VAS)|With VAS, participants specify their level of agreement to a statement by indicating a position along a continuous line between two endpoints, with 0 being the lowest level and 100 being the highest level of morning stiffness.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the assessment of Duration of Morning Stiffness on the VAS were included in this analysis.|||units on a scale||Standard Deviation|Mean
2656587|NCT01613378|Secondary|Change From Baseline in Disease Activity Score 28 (DAS28)|The DAS28 scale is a combined index for measuring disease activity in rheumatoid arthritis. Scores range from 0 to 10, with higher scores representing more disease activity.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the DAS28 assessment were included in this analysis.|||units on a scale||Standard Deviation|Mean
2656588|NCT01613378|Secondary|Change From Baseline in Swollen Joint Count (SJC)|Following an assessment of 66 joints for swelling, joints were classified as swollen or not swollen by the investigator.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Swollen Joint Count were included in this analysis.|||swollen joints||Standard Deviation|Mean
2656589|NCT01613378|Secondary|Change From Baseline in Tender Joint Count (TJC)|Following an assessment of 68 joints for tenderness, joints were classified as tender or not tender by the investigator.|From baseline to Month 12|Full analysis set (FAS) population consisted of all participants included in the study who received at least one dose of Tocilizumab (n=198). Only participants who completed the Tender Joint Count were included in this analysis.|||tender joints||Standard Deviation|Mean
2656590|NCT01613378|Primary|Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation||At 6 months|All participants enrolled in the study.|||percentage of participants||95% Confidence Interval|Number
2656591|NCT01613339|Secondary|Activities-specific Balance Confidence Scale|16 item questionnaire that investigates balance self-efficacy. Each items is a question; How secure are you that you will not fall when you...sweep the floor? The participant are asked to grade his/hers feeling of secutiry from 0, 10, 20 and so on up to 100. 0 is regarded low balance self-efficacy. The item responses are summed and divided by 16.|Change from baseline in Activities-specific Balance confidence scale at 9 weeks||||units on a scale||Standard Deviation|Mean
2656592|NCT01613339|Primary|Bergs Balance Scale|"Test of functional balance. Includes 14 items all graded 0-4 where 0 indicate larger impairment. Total score is used here, maximum 56 and minimum 0.~The Berg balance scale was developed for older patients but is a much used meausure of dynamic and static functional balance."|Change from baseline in Bergs balance scale at 9 weeks||||units on a scale||Standard Deviation|Mean
2656593|NCT01613339|Secondary|Timed Up and Go Test|test of functional mobility. Time is taken in seconds. The participants sits on a chair with armrests are then asked to rise, walk 3 meters, turn and walk back and sit down.|Change from baseline in Timed Up and Go test at 9 weeks||||seconds||Standard Deviation|Mean
2656594|NCT01613326|Secondary|Mean Daily, Daytime and Nighttime (Combined) Symptom Scores Over the 12 Week Treatment Period|Participants completed eDiaries providing scores 0 to 3 for symptoms: Cough and wheeze (none, mild, moderate, severe); sputum volume (none, less than 5 mL, 5-25 mL, >25 mL); sputum color (none, white-grey, yellow, green); lowest level of activity causing breathlessness (never or only when running, when walking uphill or upstairs, when walking on flat ground, at rest). Symptoms in the morning, for the previous night (no waking due to symptoms, woke up once due to symptoms, woke up more than once due to symptoms, woke up frequently or could not sleep due to symptoms). Symptoms experienced during the day that had prevented them for performing normal activities (not at all, a little, quite a lot, completely). The mean change from baseline in the total scores and in the individual scores was summarized by treatment. Only participants with a value at both baseline and post-baseline were included. Possible total scores 0-18 (night); 0-36 (day). A higher score means worsening of symptoms.|12 weeks|The per-protocol set included all randomized patients who received at least one dose of study drug. Only patients with a value at both baseline and post-baseline are included.|||units on a scale||Standard Deviation|Mean
2656595|NCT01613326|Secondary|Event Free Rate at Weeks 4, 8 and 12 After Treatment|Event free rate was calculated as a percentage of participants who did not experience any moderate or severe COPD exacerbation leading to hospitalization/treatment with systemic corticosteroids/treatment with antibiotics. The event free rate reflects the percent of patients who did NOT have an exacerbation by 4, 8 and 12 weeks. Event-free rates are calculated at the end of the specified weeks (i.e. Day 29, Day 57 and Day 85) by the Kaplan Meier method.|Weeks 4, 8 and 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations and described as patients with moderate to severe exacerbations were included in this analysis.|||percentage of participants||95% Confidence Interval|Number
2656596|NCT01613326|Secondary|Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (5 Min-4 h) Post-dose|"Forced Expiratory Volume in one second (FEV1) was measured with spirometry conducted according to internationally accepted standards.~Area Under the Curve (AUC) is calculated using the trapezoidal rule using the existing FEV1 measurements (i.e., the missing FEV1 measurements are not interpolated).~ANCOVA model: FEV1 AUC = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region."|Day 1 and week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations.|||Liters||Standard Error|Least Squares Mean
2656597|NCT01613326|Secondary|Forced Vital Capacity (FVC) at Each Time-point by Visit|Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. ANCOVA model: FVC = treatment + baseline FVC + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region.|(5,15,30 min, 1, 2,3,4 h, 23h 15 min and 23h 45 min postdose of Day 1), (-45, -15 min predose, 5,15,30 min, 1h, 23h 15 min and 23h 45 min postdose of Week 4), (-45, -15 min predose, 5,15,30 min, 1, 2, 3,4 h, 23h 15 min and 23h 45 min postdose of Week 12)|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations|||Liters||Standard Error|Least Squares Mean
2656598|NCT01613326|Secondary|Forced Expiratory Volume in 1 Second (FEV1) at Each Time-point by Visit|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 was analyzed using Analysis of Covariance (ANCOVA) model: FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region.|(5,15,30 min, 1, 2,3,4 h, 23h 15 min and 23h 45 min postdose of Day 1), (-45, -15 min predose, 5,15,30 min, 1h, 23h 15 min and 23h 45 min postdose of Week 4), (-45, -15 min predose, 5,15,30 min, 1, 2, 3,4 h, 23h 15 min and 23h 45 min postdose of Week 12)|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations|||Liters||Standard Error|Least Squares Mean
2656599|NCT01613326|Secondary|Inspiratory Capacity (IC) at Each Time-point, by Visit|IC was measured with spirometry conducted according to internationally accepted standards. ANCOVA model: IC = treatment + baseline IC + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region.|(25 min, 1 h 55 min, 3 h 55 min, 23 h 40 min Day 1), (-20 min, 25 min, 23 h 40 min Week 4),(-20 min, 25 min, 1 h 55 min, 3 h 55 min, 23 h 40 min Week 12)|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations|||Liters||Standard Error|Least Squares Mean
2656600|NCT01613326|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) During 5 Min to 4 Hours Post-dose, at Day 1 and Week 12|Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded during first 4 hours post dose. ANCOVA model: Peak FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center (region). Center is included as a random effect nested within region. This analysis excludes values within 6 hours of rescue medication use or 7 days of systemic corticosteroid use.|5 min to 4 hours post-dose at Day 1 and Week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations|||Liters||Standard Error|Least Squares Mean
2656601|NCT01613326|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Week 4|"FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.~Trough FEV1 is defined as the average of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. Trough assessments taken outside 22 h 45 min - 24 h 15 min are excluded from this analysis.~ANCOVA model: Trough FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region."|Day 1 and Week 4|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations or who did not take study drug as per protocol in the 14 day period prior to trough.|||Liters||Standard Error|Least Squares Mean
2656602|NCT01613326|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Used Over the 12 Week Treatment|"A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours.~Baseline mean daily, daytime and nighttime (combined) number of puffs is defined as the average of the respective number of puffs. Only patients with a value at both baseline and post-baseline visits were included."|Baseline and Day 1 to Week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with a value at both baseline and post-baseline visits were included.|||puffs||Standard Deviation|Mean
2656603|NCT01613326|Secondary|St. George's Respiratory Questionnaire Total Score After 12 Weeks of Treatment|St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. ANCOVA model: SGRQ total score = treatment + baseline SGRQ score + baseline ICS use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center (region).|Week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations.|||Units on a scale||Standard Error|Least Squares Mean
2656604|NCT01613326|Secondary|Transition Dyspnea Index (TDI) Focal Score After 4 Weeks and 12 Weeks of Treatment|"Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.~ANCOVA model: TDI focal score = treatment + Baseline dyspnea index (BDI) + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). Center is included as a random effect nested within region."|Weeks 4 and 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations.|||Units on a scale||Standard Error|Least Squares Mean
2656605|NCT01613326|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Analysis of Superiority)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23h 15min and 23h 45min post dosing. ANCOVA model: Trough FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center(region). This analysis excluded values within 6 hours of rescue medication use or 7 days of systemic corticosteroid.|Week 12|The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug and had available data for analysis.|||Liters||Standard Error|Least Squares Mean
2656606|NCT01613326|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 12 Weeks of Treatment (Non-inferiority Analysis)|Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23hours 15min and 23 hours 45min post dosing. ANCOVA model: Trough FEV1 = treatment + baseline FEV1 + baseline Inhaled corticosteroid (ICS) use (Yes/No) + FEV1 reversibility components + baseline smoking status + region + center (region). This analysis excluded values within 6 hours of rescue medication use or 7 days of systemic corticosteroid use.|Week 12|The per-protocol set included all randomized patients who received at least one dose of study drug, with available data and without any major protocol deviations or who did not take study drug as per protocol in the 14 day period prior to trough.|||Liters||Standard Error|Least Squares Mean
2656607|NCT01613313|Secondary|Relative Change in Volume of the Lipoma|A secondary outcome is the relative change in volume of the lipoma as determined by MRI. This outcome will be analyzed as the change from baseline to 6 months post injection.|Baseline and 6 months post injection of study drug|Analysis is based on the population that consists of all subjects who are enrolled and received administration of study drug|||Percent reduction from baseline||Standard Deviation|Mean
2656608|NCT01613313|Primary|Change in Visible Surface Area of the Lipoma|The primary efficacy outcome is the visible surface area of the lipoma measured as the longest dimension (length) times the longest dimension perpendicular to length (width). Visible surface area will be determined by caliper and will be analyzed as the percent change from baseline at the 6-month post injection visit.|Baseline and Six months post injection of study drug|Analysis population consists of all subjects who were enrolled and received the administration of study drug.|||Percent change from baseline||Standard Deviation|Mean
2656609|NCT01613248|Secondary|Percentage of Participants Reporting TMF at 2-48 Hours Post-Dose|TMF at 2-48 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2 to 48 hour period after dosing with study medication.|2-48 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2656610|NCT01613248|Secondary|Percentage of Participants Reporting TMF at 2-24 Hours Post-Dose|TMF at 2-24 hours post-dose was defined as SPF with no photophobia, phonophobia, nausea, or vomiting during the 2 to 24 hour period after dosing with study medication.|2-24 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2656611|NCT01613248|Secondary|Percentage of Participants Reporting Total Migraine Freedom (TMF) at 2 Hours Post-Dose|TMF at 2 hours post dose was defined as PF with no photophobia, phonophobia, nausea, or vomiting at 2 hours post-dose.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2656637|NCT01613027|Secondary|Percentage of Serious ADRs|"Percentage of serious ADRs resolved and ongoing at the time of study completion was reported.~An ADR was defined as any noxious and unintended response to a medicinal product related to any dose."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||percentage of serious ADRs|Participants||Number
2656612|NCT01613248|Secondary|Percentage of Participants Reporting SPR 2-48 Hours Post-Dose|SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 48 hour period after dosing with study medication.|2-48 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2656613|NCT01613248|Secondary|Percentage of Participants Reporting Sustained Pain Relief (SPR) 2-24 Hours Post-Dose|SPR was defined as PR at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a moderate/severe headache during the 24 hour period after dosing with study medication.|2-24 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2656614|NCT01613248|Secondary|Percentage of Participants Reporting SPF 2-48 Hours Post-Dose|SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 48 hour period after dosing with study medication.|2-48 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2656615|NCT01613248|Secondary|Percentage of Participants Reporting Sustained Pain Freedom (SPF) 2-24 Hours Post-Dose|SPF was defined as PF at 2 hours post-dose, with no administration of any rescue medication and with no occurrence of a mild/moderate/severe headache during the 24 hour period after dosing with study medication.|2-24 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2656616|NCT01613248|Secondary|Percentage of Participants Reporting Absence of Nausea at 2 Hours Post-Dose||2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2656617|NCT01613248|Secondary|Percentage of Participant Reporting Absence of Photophobia at 2 Hours Post-Dose|Photophobia is sensitivity to bright light.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2656618|NCT01613248|Secondary|Percentage of Participants Reporting Absence of Phonophobia at 2 Hours Post-Dose|Phonophobia is sensitivity to loud sounds.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2656619|NCT01613248|Primary|Number of Participants Who Discontinued From Study Due to Adverse Events||Up to 5 weeks post-dose|ASaT population included all randomized participants who received at least one dose of study treatment.|||participants|||Number
2656620|NCT01613248|Primary|Number of Participants With One or More Adverse Events Within 14 Days Post-Dose|An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a sponsor product, whether or not considered related to the use of the product.|Up to 14 days post-dose|ASaT population included all randomized participants who received at least one dose of study treatment.|||participants|||Number
2656621|NCT01613248|Primary|Number of Participants With One or More Adverse Events Within 48 Hours Post-Dose|An AE is any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a sponsor product, whether or not considered related to the use of the product.|Up to 48 hours post-dose|All Subjects as Treated (ASaT) population included all randomized participants who received at least one dose of study treatment.|||participants|||Number
2656622|NCT01613248|Primary|Percentage of Participants Reporting Pain Relief (PR) at 2 Hours Post-Dose|PR was defined as a reduction of a moderate or severe migraine headache (Grade 2 or 3) at Baseline to a mild headache or no headache (Grade 1 or 0) 2 hours post-dose. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2656623|NCT01613248|Primary|Percentage of Participants Reporting Pain Freedom (PF) at 2 Hours Post-Dose|PF was defined as a reduction in headache severity from Grade 2 or 3 at Baseline to Grade 0. Headache severity was reported by the participant using a 4-point scale where: 0=no pain, 1=mild pain, 2=moderate pain and 3=severe pain.|2 hours post-dose|Participants from the Full Analysis Set, all participants who received treatment and had both a Baseline and at least one post-dose efficacy measurement, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2656624|NCT01613222|Primary|Accuracy Root Mean Square (ARMS)|The Accuracy Root Mean Square (ARMS) calculation is used to measure accuracy of the test SpO2 device compared to reference SpO2 device. A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around the line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square (ARMS). The smaller ARMs the closer the data points lie around the line of identity, representing a more accurate sensor as accurate and appropriate. Data analysis follows ISO 80601-2-61, 2011, Annex EE and the FDA Guidance Document for Pulse Oximeters (FDA Draft Guidance, July 19, 2007).|60 minutes|The data analyzed was SpO2 data pairs using different U-Trusginal SpO2 sensors, patient monitors, co-oximeters, and various modules. Multiple data pairs were collected from each study participant, but not all sensors, patient monitors, co-oximeters and module configurations were used with each participant.|||Accuracy Root Mean Square|Number of Data Pairs|Full Range|Mean
2656625|NCT01613131|Primary|Fatigue|The Fatigue Severity Scale (FSS) was used to determine the degree to which night-time sleep difficulty manifested as daytime sleepiness. The FSS is a 9-item scale assessing fatigue over the past week, on a 7-point Likert scale (ranging from 1-7). It is scored by averaging the individual item scores, with higher scores indicating greater fatigue. Scores greater than or equal to 5.5 are generally indicative of insomnia with impaired daytime functioning.|Day 140|3 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
2656626|NCT01613131|Primary|Fatigue|The Fatigue Severity Scale (FSS) was used to determine the degree to which night-time sleep difficulty manifested as daytime sleepiness. The FSS is a 9-item scale assessing fatigue over the past week, on a 7-point Likert scale (ranging from 1-7). It is scored by averaging the individual item scores, with higher scores indicating greater fatigue. Scores greater than or equal to 5.5 are generally indicative of insomnia with impaired daytime functioning.|Day 90|3 women in the Mirena + Estradiol Gel arm, and 6 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
2656627|NCT01613131|Primary|Depression|The Center for Epidemiologic Studies-Depression Scale (CES-D) is a 20-item scale with 4-point Likert responses indicating frequency of symptoms over past week. Scores range from 0-60, with scores >16 considered indicative of depressive symptoms.|Day 140|3 women in the Mirena + Estradiol Gel arm, and 6 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
2656628|NCT01613131|Primary|Depression|The Center for Epidemiologic Studies-Depression Scale (CES-D) is a 20-item scale with 4-point Likert responses indicating frequency of symptoms over past week. Scores range from 0-60, with scores >16 considered indicative of depressive symptoms.|Day 90|4 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
2656629|NCT01613131|Primary|Hot Flashes|The Hot Flash Related Daily Interference Scale (HFRDIS) is a ten item scale measuring degree to which hot flashes interfere with 9 daily activities (work, social, leisure, sleep, mood, concentration, relations, sexuality, enjoyment of life, overall quality of life) over the prior week, each scored on a 10 point Likert scale. The total score is reported, and scores range from 0-100, 100 being the worst outcome.|Day 140|3 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide data; thus, were not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
2656630|NCT01613131|Primary|Hot Flashes|The Hot Flash Related Daily Interference Scale (HFRDIS) is a ten item scale measuring degree to which hot flashes interfere with 9 daily activities (work, social, leisure, sleep, mood, concentration, relations, sexuality, enjoyment of life, overall quality of life) over the prior week, each scored on a 10 point Likert scale. The total score is reported, and scores range from 0-100, 100 being the worst outcome.|Day 90|3 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
2656631|NCT01613131|Primary|Sleep|The Pittsburgh Sleep Quality Index (PSQI) is a 19-item scale designed to measure general sleep disturbances over the previous month (sleep wake patterns, duration of sleep, sleep latency, impact of poor sleep on daytime functioning, assesses specific problems contributing to poor sleep, including pain, urination, breathing difficulty, snoring, dreams, temperature). The global score is reported and ranges from 1-21, with higher scores being indicative of poorer sleep.|Day 140|5 women in the Mirena + Estradiol Gel arm, and 7 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
2656632|NCT01613131|Primary|Sleep|The Pittsburgh Sleep Quality Index (PSQI) is a 19-item scale designed to measure general sleep disturbances over the previous month (sleep wake patterns, duration of sleep, sleep latency, impact of poor sleep on daytime functioning, assesses specific problems contributing to poor sleep, including pain, urination, breathing difficulty, snoring, dreams, temperature). The global score is reported and ranges from 1-21, with higher scores being indicative of poorer sleep.|Day 90|3 women in the Mirena + Estradiol Gel arm, and 5 women in the Mirena + Placebo Gel did not provide complete data; thus, were not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
2656633|NCT01613131|Primary|Fatigue|The Fatigue Severity Scale (FSS) was used to determine the degree to which night-time sleep difficulty manifested as daytime sleepiness. The FSS is a 9-item scale assessing fatigue over the past week, on a 7-point Likert scale (ranging from 1-7). It is scored by averaging the individual item scores, with higher scores indicating greater fatigue. Scores greater than or equal to 5.5 are generally indicative of insomnia with impaired daytime functioning.|Day 0|One woman in the Mirena + Placebo Gel arm did not provide complete data for this outcome measure; thus she was not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
2656634|NCT01613131|Primary|Depression|The Center for Epidemiologic Studies-Depression Scale (CES-D) is a 20-item scale with 4-point Likert responses indicating frequency of symptoms over past week. Scores range from 0-60, with scores >16 considered indicative of depressive symptoms.|Day 0|Two women in the Mirena + Placebo Gel did not provide complete data for this outcome measure; thus they were not included in the analysis for this timepoint.|||scores on a scale||Standard Error|Mean
2656635|NCT01613131|Primary|Sleep|The Pittsburgh Sleep Quality Index (PSQI) is a 19-item scale designed to measure general sleep disturbances over the previous month (sleep wake patterns, duration of sleep, sleep latency, impact of poor sleep on daytime functioning, assesses specific problems contributing to poor sleep, including pain, urination, breathing difficulty, snoring, dreams, temperature). The global score is reported and ranges from 1-21, with higher scores being indicative of poorer sleep.|Day 0||||scores on a scale||Standard Error|Mean
2656636|NCT01613131|Primary|Hot Flashes|The Hot Flash Related Daily Interference Scale (HFRDIS) is a ten item scale measuring degree to which hot flashes interfere with 9 daily activities (work, social, leisure, sleep, mood, concentration, relations, sexuality, enjoyment of life, overall quality of life) over the prior week, each scored on a 10 point Likert scale. The total score is reported, and scores range from 0-100, 100 being the worst outcome.|Day 0||||scores on a scale||Standard Error|Mean
2656638|NCT01613027|Secondary|Percentage of Serious AEs|"Percentage of serious AEs resolved and ongoing at the time of study completion was reported.~An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||percentage of serious AEs|Participants||Number
2656639|NCT01613027|Secondary|Percentage of Non-Serious ADRs|"Percentage of non-serious ADRs at the time of study completion was reported.~An ADR was defined as any noxious and unintended response to a medicinal product related to any dose."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||percentage of non-serious ADRs|Participants||Number
2656640|NCT01613027|Secondary|Percentage of Non-Serious AEs|"Percentage of non-serious AEs resolved and ongoing at the time of study completion were reported.~An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||percentage of non-serious AEs|Participants||Number
2656641|NCT01613027|Secondary|Percentage of Participants With Any Non-Serious AE and Any Serious AE by Intensity|"Percentage of participants with any non-serious AE and any serious AE by intensity (mild, moderate, severe) was reported.~An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||percentage of participants|||Number
2656642|NCT01613027|Secondary|Percentage of Participants With Adverse Events (AEs) and Adverse Drug Reactions (ADRs)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An ADR was defined as any noxious and unintended response to a medicinal product related to any dose. AEs of special interest includes progressive multifocal leukoencephalopathy (PML), any encephalopathy, hepatitis B or hepatitis B reactivation, gastrointestinal perforation, tuberculosis (TB) or TB reactivation, opportunistic infections, and malignancies.|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||percentage of participants|||Number
2656643|NCT01613027|Secondary|Percentage of Participants With Clinically Meaningful Improvement From Baseline in Modified Health Assessment Questionnaire (M-HAQ)|"The M-HAQ is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. A negative change from baseline indicates improvement.~Clinically meaningful improvement was defined as minimum clinically significant reduction from baseline of ≥0.22 at the respective time point."|Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. Data for change from baseline at Month 6 and Month 12 are included for participants with available data at each time point.|||percentage of participants||95% Confidence Interval|Number
2656644|NCT01613027|Secondary|Reasons for Discontinuation of Treatment by Month 12|Reasons for discontinuation from baseline to Month 12 are presented as the number of participants who discontinued treatment by category of reason for discontinuation.|Baseline to Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||participants|||Number
2656645|NCT01613027|Secondary|Reasons for Discontinuation of Treatment by Month 6|Reasons for discontinuation from baseline to Month 6 are presented as the number of participants who discontinued treatment by category of reason for discontinuation.|Baseline to Month 6|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||participants|||Number
2656646|NCT01613027|Secondary|Percentage of Participants Who Remained on Treatment or Discontinued Treatment by Month 6 and Month 12||Up to 12 months|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||percentage of participants|||Number
2656647|NCT01613027|Secondary|Change From Baseline in C-reactive Protein (CRP) at Month 6 and Month 12|C-reactive protein (CRP) is a blood test marker for inflammation in the body. Normal CRP levels are below 5.0 milligrams per liter (mg/L). A decrease from baseline indicates improvement.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. Data at Month 6 and Month 12 are included for participants who had assessments for CRP.|||mg/L||Standard Deviation|Mean
2656648|NCT01613027|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and Month 12|ESR is an direct measure of how much inflammation is in the body. The normal range is 0-22 mm/hour for men and 0-29 mm/hour for women. A decrease from baseline indicates improvement.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||mm/hour||Standard Deviation|Mean
2656649|NCT01613027|Secondary|Change From Baseline in Tender Joint Count (TJC) at Month 6 and Month 12|TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. A decrease from baseline indicates improvement.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||tender joints||Standard Deviation|Mean
2656650|NCT01613027|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Month 6 and Month 12|SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status. A decrease from baseline indicates improvement.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||swollen joints||Standard Deviation|Mean
2656651|NCT01613027|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 and Month 12|EULAR response was calculated as the difference between DAS28-ESR scores at baseline and Month 6, and baseline and Month 12, and reported as the percentage of participants with response overall, good response, moderate response, and no response measured at each time point. Good responders = decrease from baseline >1.2 with a DAS28 score of ≤3.2; moderate responders = decrease from baseline >1.2 with a DAS28 score of >3.2, or decrease from baseline >0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = decrease from baseline ≤0.6 or decrease from baseline >0.6 and ≤1.2 with a DAS28 score of >5.1.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||percentage of participants||95% Confidence Interval|Number
2656652|NCT01613027|Primary|Change From Baseline in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Month 6 and Month 12|DAS28-ESR is a measure of the participant's disease activity and was calculated using the swollen joint count of 28 joints (SJC28), tender joint count of 28 joints (TJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment of disease activity (100-millimeter [mm] horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity). DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity.|Baseline, Month 6, Month 12|Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.|||units on a scale||Standard Deviation|Mean
2656653|NCT01613014|Primary|Weekly Percentage of Heaving Drinking Days|"The primary objective of this study is to assess the efficacy of ABT-436 to reduce the weekly percentage of heavy drinking days (reduction in drinking) in subjects with alcohol dependence confirmed by DSM-IV-TR criteria. A heavy drinking day is 4 or more drinks per drinking day for women and 5 or more drinks per drinking day for men.~The outcome measure was averaged across weeks 2-12."|Weeks 2-12|Models are based on a mITT population that included subjects who received at least one dose of medication (N=144; ABT-436=73, placebo=71). One additional placebo subject had no drinking data during the maintenance period, and one ABT-436 subject was missing data on a baseline covariate, resulting in an analyzable N=142 (ABT-436=72, placebo=70).|||weekly percentage of heavy drinking days||95% Confidence Interval|Least Squares Mean
2656654|NCT01612884|Secondary|Number of Participants With Bleeding Events|Major or Minor Bleeding according to TIMI criteria|6 months||||Participants|||Count of Participants
2656655|NCT01612884|Secondary|Number of Participants With Ischemic Events|Death, recurrent myocardial infarction, recurrent unstable angina, repeat coronary intervention|6 months||||Participants|||Count of Participants
2656656|NCT01612884|Primary|Thrombelastography (TEG) MA|Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel|1 day|TEG-MA (mm) at 16-24 hours outcome measure|||mm||Standard Deviation|Mean
2656657|NCT01612858|Secondary|Change in Hepatic Fat From Baseline to Week 12 Post-treatment With an Insulin Sensitizing Agent|Change in hepatic fat was measured after 12 weeks of treatment with metformin or pioglitazone using magnetic resonance spectroscopy|12 weeks|Only participants with baseline and post insulin sensitizing treatment magnetic resonance spectrosocpy were included in this analysis.|||percentage of hepatic fat||Standard Deviation|Mean
2656658|NCT01612858|Primary|Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent|Change in insulin sensitivity measured by 2 hour euglycemic-hyperinsulinemic clamp from baseline to week 12 post treatment with metformin or pioglitazone|3 months|Only participants with baseline and post insulin-sensitizing treatment euglycemic-hyperinsulinemic clamp were included in this analysis|||mg/kg lean body mass/min||Standard Deviation|Mean
2656659|NCT01612793|Primary|Change in the Length of Stay in the Hospital|"The primary outcome measure was hospital length of stay (LOS) defined as the number of days from hospital admission to the date the subject met the medical elements of the GOLD Discharge Criteria. (Global Initiative for Chronic Obstructive Lung Disease report, Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease, Revised 2011)"|Admission to hospital, 1 week in-person visit and a 30 day phone call follow-up visit from time of discharge from the hosptal|Safety population|||Days||Full Range|Mean
2656660|NCT01612767|Secondary|Angina Pectoris Classification|"Evaluate the angina pectoris classification at each study visit.~Stable angina pectoris was classified according to the Canadian Cardiovascular Society's System: Stable Angina - Class I: normal activity does not cause angina; Stable Angina - Class II: slight limitation of normal activity, moderate exertion may cause angina; Stable Angina - Class III: marked limitation of ordinary physical activity; Stable Angina - Class IV: discomfort with any physical activity and pain may be present at rest~Unstable angina pectoris was classified according to the Braunwald System: Numeral I: newly onset severe or accelerated angina with no pain at rest; Numeral II: angina at rest within the preceding month but not the past 48 hours Numeral III: angina at rest within the preceding 48 hours; Letter A: develops in presence of conditions which intensify ischemia; Letter B: develops in the absence of extracardiac conditions; Letter C: develops within 2 weeks after an acute myocardial infarction"|Basline, Discharge, 1, 9, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants|||Number
2656661|NCT01612767|Secondary|Lesion Success During the Index Procedure|Evaluate the lesion success associated with the implant of the PRO-Kinetic Energy stent. Lesion success is defined as the successful delivery and deployment of the investigational stent at the intended target lesion in combination with any adjunctive device (if applicable) to attain a final residual stenosis of < 30% by operator visual estimate.|Index procedure||||Percentage of participants|||Number
2656662|NCT01612767|Secondary|Device Success During the Index Procedure|Evaluate the device success associated with the implant of the PRO-Kinetic Energy stent. Device success is defined as the successful delivery and deployment of the investigational stent at the intended target lesion in combination with standard post-dilation (if applicable) to attain a final residual stenosis of < 30% by operator visual estimate.|Index procedure||||Percentage of participants|||Number
2656679|NCT01612676|Primary|Time to Septic Shock Resolution|"The Kaplan-Meyer estimation of time to out of septic shock was estimated where time to (first) septic shock resolution was defined as time of end of infusion regimen. Intermittent off treatment periods were regarded as part of the shock duration.~Time to all but one patient out of septic shock is presented."|Day 1 up to Day 28|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||Hours|||Number
2656663|NCT01612767|Secondary|Index Procedure Success|Evaluate the index procedure success associated with the implant of the PR-Kinetic Energy stent. procedure success is defined as the successful delivery and deployment of the investiational stent at the intended target lesion in combination with any adjunctive device (if applicable) to attain a final residual stenosis of < 30% by operator visual estimate without the occurrence of cardiac death, any MI (target vessel or non-target vessel) or TLR prior to hospital discharge.|Index procedure||||Percentage of participants|||Number
2656664|NCT01612767|Secondary|Stent Thrombosis Rate|Evaluate the stent thrombosis rate associated with the PRO-Kinetic Energy stent. Stent thrombosis was classified according to both timing and evidence as outlined by the ARC definition of stent thrombosis. Participants were included in the evaluations at visit intervals if they had a visit at the specified interval or a thrombosis was reported at or before the visit.|1, 9, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants|||Number
2656665|NCT01612767|Secondary|All-cause Mortality and All-cause MI - Contribution of Individual Rates|Contribution of the individual rates of mortality and myocardial infarction to the overall composite safety rate.|1, 9, 12, 24, and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants|||Number
2656666|NCT01612767|Secondary|Composite of All-cause Mortality and All-cause MI|Characterize the overall safety of the PRO-Kinetic Energy stent by evaluating the composite rate of all-cause mortality and all-cause myocardial infarction.|1, 9, 12, 24, and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants|||Number
2656667|NCT01612767|Secondary|Overall Target Lesion Revascularization Rate|Evaluate the overall target lesion revascularization rate associated with the PRO-Kinetic Energy stent. The overall target lesion revascularization rate includes both ischemia-driven revascularization procedures of the target lesion, as well as revascularization procedures of the target lesion without prior clinical symptoms.|1, 9, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants|||Number
2656668|NCT01612767|Secondary|Target Lesion Failure Rate - Contribution of Individual Event Types|The contribution of each individual event of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization to the overall rate of target lesion failure.|1, 9, 12, 24, and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants|||Number
2656669|NCT01612767|Secondary|Overall Target Lesion Failure Rate|Evaluate the target lesion failure rate of the PRO-Kinetic Energy stent. Target lesion failure includes cardiac death, MI, and ischemia-driven target lesion revascularization.|1, 9, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants|||Number
2656670|NCT01612767|Secondary|Overall Target Vessel Revascularization Rate|Evaluate the overall target vessel revascularization rate of the PRO-Kinetic Energy stent. The rate includes both ischemia-driven revascularization procedures of the target vessel, as well as revascularization procedures of the target vessel without prior clinical symptoms.|1, 9, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants|||Number
2656671|NCT01612767|Secondary|Target Vessel Failure Rate - Contribution of Individual Event Types|Contribution of each event type (cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization) to composite rate of target vessel failure.|1, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants|||Number
2656672|NCT01612767|Secondary|Target Vessel Failure Rate|Evaluate the target vessel failure rate at 1, 12, 24, and 36 months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction (MI) and ischemia-driven target vessel revascularization.|1, 12, 24 and 36 months post-index procedure|Long term follow-up data collection is ongoing for the 12, 24 and 36 month intervals.|||Percentage of participants|||Number
2656673|NCT01612767|Primary|Target Vessel Failure Rate|The primary endpoint for the Pro-Kinetic Energy Stent is the target vessel failure rate at 9-months post-index procedure. Target vessel failure is defined as cardiac death, myocardial infarction and ischemia-driven target vessel revascularization.|9 months post-index procedure||||Percentage of participants||95% Confidence Interval|Number
2656674|NCT01612702|Secondary|Wound Complication|Number of participants with a sinus tract communicating with the prosthesis; a pathogen was isolated by culture from tissue or fluid samples taken from the affected joint; tests revealed elevated serum erythrocyte sedimentation rate (ESR) or serum C-reactive protein (CRP) concentration with elevated synovial white blood cell (WBC) count or neutrophil percentage; or pus discharge from the affected joint was present within 30 days after total knee arthroplasty were measured.|within 30 days after surgery||||participant|||Number
2656675|NCT01612702|Secondary|Pain Level|A blinded investigator asked participants to recall the most severe pain level during 6 to 24 hour after surgery using with a visual analogue scale that ranged from 0 (no pain) to 10 (worst imaginable pain).|6 to 24 hours after surgery||||units on a scale||Standard Deviation|Mean
2656676|NCT01612702|Primary|Incidence of Nausea and Vomiting|A clinical investigator who is blinded to randomization assessed the incidence of postoperative nausea which defined as subjective unpleasant sensation associated with awareness of the urge to vomit and as emetic episode and vomiting|within 72 hours after surgery||||percentage of participant||95% Confidence Interval|Number
2656677|NCT01612676|Secondary|Adverse Effects on Lab Parameters, Vital Signs and Electrocardiogram|Significant changes for vital signs (blood pressure, heart rate, mean arterial pressure), electrocardiogram (ECG), and laboratory parameters (clinical chemistry, haematology, haemostasis, and urinary parameters).|Day 1 up to Day 7, and at follow-up assessments performed 24-72 hours after end of IMP infusion|The safety analysis set comprised of all allocated and dosed patients and were analyzed according to the actual dosing regimen received.|||patients|||Number
2656678|NCT01612676|Secondary|Mortality|Collection of data on mortality was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital.|Day 1 up to Day 28|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||patients|||Number
2656680|NCT01612676|Primary|Infusion Rate of Norepinephrine|Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Infusion rates and all changes in infusion rates of norepinephrine were recorded continuously during the 7 day maximum treatment period.|Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. One patient in the 7.5 ng/kg/min group started the vasopressor support without prior administration of norepinephrine, and MAP was adequately controlled as needed.|||µg/kg/min||Standard Deviation|Mean
2656681|NCT01612676|Primary|Cumulative Dose of Norepinephrine|Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Cumulative dose of norepinephrine was calculated from Day 1 up to Day 7.|Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. One patient in the 7.5 ng/kg/min group started the vasopressor support without prior administration of norepinephrine, and MAP was adequately controlled as needed.|||µg/kg||60% Confidence Interval|Mean
2656682|NCT01612676|Primary|Infusion Rate of FE 202158|Infusion rate of FE 202158 was presented from Day 1 up to Day 7.|Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||ng/kg/min||Standard Deviation|Mean
2656683|NCT01612676|Primary|Cumulative Dose of FE 202158|Cumulative dose of FE 202158 was calculated from Day 1 up to Day 7.|Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||ng/kg||60% Confidence Interval|Mean
2656684|NCT01612676|Secondary|Graded Morbidity|Collection of data on graded morbidity was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital.|Day 1 up to Day 28|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||patients|||Number
2656685|NCT01612676|Secondary|Morbidity Assessment|"Percentage of all the Days alive and out/free of intensive care unit, hospital, dialysis, or ventilation within Day 28 were summarized. Patients dying before or at Day 28 were counted as zero."|Day 1 up to Day 28|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||percentage of days within 28 days|||Number
2656686|NCT01612676|Secondary|Summary of Investigator Reported Outcomes|Investigator reported outcome on FE 202158 performance. Answers were graded on a visual analogue scale (VAS) from 0 to 10, 0 being the worst and 10 being the best outcome.|Day 1 up to Day 2|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||Score on scale||Standard Deviation|Mean
2656687|NCT01612676|Secondary|Fluid Balance|The fluid balance (accumulated input/output) was recorded in 24-hour collecting periods when the patient was in the intensive care unit and during the infusion of FE 202158.|Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||mL/kg||60% Confidence Interval|Mean
2656688|NCT01612676|Secondary|Urinary Output|The urinary output was recorded every 24 hours up to Day 7, or as long as the patient was in intensive care unit.|Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||mL/kg||60% Confidence Interval|Mean
2656689|NCT01612676|Primary|Percentage of Patients Maintaining Target/Adequate Mean Arterial Pressure (MAP>60 mmHg) Without Norepinephrine|Mean arterial pressure (MAP) was measured intra-arterially on a continuous basis. Success percentage of patients maintaining target/adequate MAP (>60 mmHg) without norepinephrine is presented.|Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.|Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.|||Percentage of patients||60% Confidence Interval|Number
2656690|NCT01612546|Secondary|Incidence of Adverse Events|Incidence of treatment related adverse events graded per NCI CTCAE version 4.03|Up to 4 years||||participants|||Number
2656691|NCT01612546|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|From date of start of therapy to date of death due to any cause, assessed up to 4 years||||months||95% Confidence Interval|Median
2656692|NCT01612546|Secondary|Clinical Benefit Rate|Patients with a best response of Complete Response, Partial Response or Stable Disease after at least 4 months of treatment assessed using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), not a CR, PR, Progression or Symptomatic Deterioration; Progression (PD), a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Symptomatic Deterioration, global deterioration of health status requiring discontinuation of treatment without objective evidence of progression. Clinical Benefit (CR + PR +SD≥4months).|At least 4 months post treatment, assessed up to 4 years||||percentage of participants|||Number
2668017|NCT01509677|Secondary|Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (IL-8 (pg/mL))||Baseline to 14 weeks||||pg/mL||Standard Error|Least Squares Mean
2656693|NCT01612546|Secondary|Overall Objective Response Rate|Patients with best response of Complete Response or Partial Response assessed using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 4 years||||percentage of participants|||Number
2656694|NCT01612546|Primary|CRLX101 (CPT) Uptake in Tumor and Nearby Normal Tissue|Using Fisher's Exact to determine statistical significance in detection of a CPT fluorescence signal posttreatment between tumor and adjacent normal tissue biopsy specimens.|Baseline and day 8|One patient was not included in the analysis because no tumor tissue was identified in the biopsy samples both pre and post-CRLX101 treatment.|||Participants|||Count of Participants
2656695|NCT01612494|Primary|Change in Pain|Self-reported pain assessment using the Wong-Baker Faces Pain Rating Scale. There are 6 faces with 5 intervals. Faces are numbered 0 to 10. Maximum score is the 6th face/10. Minimum score is the first face/0. Increasing faces represent increase in pain, decreasing faces represent decrease in pain. No subscales were included.|Following therapy to 2-3 days post discharge||||units on a scale||Standard Deviation|Mean
2656696|NCT01612351|Secondary|Describe the Kinome Response to Induction Chemotherapy (Lapatinib, Paclitaxel, and Carboplatin) in Patients Who Consent to This Optional Evaluation Via Co-enrollment in LCCC0121||11 weeks|||||||
2656697|NCT01612351|Secondary|Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0|The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.|18 weeks||||Participants|||Count of Participants
2656698|NCT01612351|Secondary|Response Rates at Both the Primary Site and in the Neck.|Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|11 weeks|||||||
2656699|NCT01612351|Secondary|Estimate the Pathologic Complete Response Rate at the Primary Site and in the Neck Following Induction Chemotherapy|Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|11 weeks|||||||
2656700|NCT01612351|Secondary|Voice and Swallowing Function - Voice-Related Quality of Life Assessment (VRQOL)|The Voice-Related Quality of Life Tool is a 10 item list of possible voice-related problems. The participant answers 1-5 with 1 being none, not a problem to 5, problem is as bad as it can be. An algorithm is used to calculate the scores, so that sum scores range from 0 to 100, where 0 indicates poor V-RQOL and 100 indicates good V-RQOL|Pre-treatment up to 1 year post surgery|Patients were encouraged to complete the assessment but at their discretion. Participants with data available reported.|||units on a scale||Standard Deviation|Mean
2656701|NCT01612351|Secondary|Voice and Swallowing Function- MD Anderson Dysphagia Inventory (MDADI)|The MD Anderson Dysphagia Inventory (MDADI) is a 20 item assessment designed to measure voice and swallowing function. Participants were asked 13 symptom questions and 6 interference items (walking, working) and asked id the 1- strongly agree to 5 strongly disagree. Scores were summed for a range of 20-100. The lower the score the worse the outcomes.|Pre-treatment up to 1 year post surgery|Subjects were encouraged to complete the assessments but it was left to their discretion. Participants with data available reported.|||units on a scale||Standard Deviation|Mean
2656702|NCT01612351|Secondary|Progression-Free Survival|"Progression-free survival associated with 3 part therapy consisting of induction chemotherapy, surgery and risk-adapted use of chemoradiation. Defined as per RECIST criteria. Physical examination, imaging of target lesions by CT scan or MRI and chest imaging (CT or Chest x-ray, if clinically indicated) every 3 months (+/- 30 days) for 18 months following end of treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR"|15 years|||||||
2656703|NCT01612351|Secondary|Overall Survival|Overall survival is measured from the time the patient goes on treatment until death.|15 years|||||||
2656704|NCT01612351|Secondary|Number of Patients Who Decreased in Risk Level Post Induction Chemotherapy.|Number of patients who no longer need radiation (have decreases in risk level post induction therapy). Estimations of Risk level pre-induction will be based on physical examination and imaging, post-induction risk level will be determined based on pathologic evaluation or surgical specimen.|11 weeks|One patient withdrew before surgery.|||Participants|||Count of Participants
2656705|NCT01612351|Secondary|Feasibility of 3 Part Therapy|Percentage of patients successfully completing 3 part therapy will be used to assess the feasibility of 3 part therapy consisting of induction chemotherapy, surgery, and risk-adapted use of chemoradiation.|2 years|||||||
2656706|NCT01612351|Primary|Overall Response Rate|Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Overall response rate (ORR) is defined as the number of patients who have a partial or complete response to therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|11 weeks||||Participants|||Count of Participants
2656708|NCT01612221|Primary|UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi|Differences in the median percent nevus with 8-OG expression in UV-irradiated nevi compares with unirradiated nevi.|3.5 years|One subject with low-risk MC1R randomized to drug was excluded from both analyses because the lesions removed were seborrheic keratoses and not nevi, and 2 subjects (one high-risk MC1R randomized to drug and one low-risk MC1R randomized to placebo) were excluded from analysis of 8-OG because there was insufficient tissue.|||percentage of 8-OG expression in nevi||Standard Deviation|Mean
2656709|NCT01612156|Secondary|Embarrassment With Pelvic Floor Examination|The participants will be asked to report their level of embarrasment during the exam using a Likert scale from 1 (no embarrassment) to 5 (most embarrasment possible) at 30 minutes after completion of the exam.|30 minutes||||On 5 point Likert scale||Full Range|Median
2656710|NCT01612156|Primary|Pain During the Pelvic Floor Examination|"Subjects will be asked to report their pain level using the Wong Baker pain scale at the beginning of the exam, after a cotton tipped swab test, after the urodynamic catheters are placed in the urethra, and then 30 minutes after the completion of the exam.~The Wong Baker pain scale ranges from 0 (no pain) to 10 (worst pain possible)."|30 minutes after completion of exam||||units on Wong Baker pain scale||Standard Deviation|Mean
2656711|NCT01612000|Primary|The Difference in Geometric Mean Titer Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.||42 Days|All subjects who received both doses of study vaccine and had pre- and post-immunization immunogenicity data for the time period summarized.|||titer||95% Confidence Interval|Geometric Mean
2656712|NCT01612000|Secondary|Long-term Safety|Incidence of Serious Adverse Events (SAEs), New Onset of Chronic Illnesses (NOCIs) and Adverse Events of Special Interest (AESIs) over 12 months following vaccination. Study subjects were followed every three months (for one year following Day 42) by telephone and visit for reports of SAEs, NOCIs, and AESIs.|13 Months|All randomized subjects who received at least one dose of study vaccine and provided any safety data following vaccination.|||participants|||Number
2656713|NCT01612000|Secondary|Reactogenicity Immediately After Each Injection, Extending to Day 7.|Solicited events of local and systemic reactogenicity Days 0-7. These events are expected to occur and not considered or recorded as Adverse Events.|7 Days|All randomized subjects who received at least one dose of study vaccine and provided any safety data following vaccination.|||participants|||Number
2656714|NCT01612000|Primary|The Difference in Seroconversion/Immunogenicity Between rHA Formulated in an oil-in- Water Adjuvant (SE) Compared to a rHA Antigen Alone.|Immunogenicity was assessed by measuring the percentage of subjects in each group exhibiting seroconversion on Day 42. The treatment groups that received adjuvanted rHA were evaluated against a non-adjuvanted rHA treatment group for whether they demonstrated seroconversion rates and 95% confidence intervals.|42 Days|All subjects who received both doses of study vaccine and had pre- and post-immunization immunogenicity data for the time period summarized.|||percentage of participants||95% Confidence Interval|Number
2656715|NCT01611974|Secondary|Half-Life (T½) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.|||hours||Standard Deviation|Mean
2656716|NCT01611974|Secondary|Area Under The Plasma Concentration Versus Time Curve From The Time of Dosing to The Last Measurable Concentration (AUClast) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.|||h*ug/mL||Standard Deviation|Mean
2656717|NCT01611974|Secondary|Time of Last Non-Zero Concentration (Tlast) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.|||hours||Standard Deviation|Mean
2656740|NCT01611857|Secondary|Overall Survival in Phase II Dose Expansion|Defined as the time from first treatment until death from any cause.|every 8 weeks until treatment discontinuation, an expected average of 18 months, then every 12 weeks thereafter up to 5 years from start of treatment.|The analysis was performed on an Intent-to-Treat basis (N=34) for all participants in the Phase II portion of the study.|||months||95% Confidence Interval|Median
2656718|NCT01611974|Secondary|Time to Maximum Concentration (Tmax) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.|||hours||Standard Deviation|Mean
2656719|NCT01611974|Secondary|Maximum Concentration (Cmax) of Maribavir|For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.|pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visit|The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations|||ug/mL||Standard Deviation|Mean
2656720|NCT01611974|Secondary|Time to CMV Recurrence|Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. The time to event was defined as the time of the first of at least 2 consecutive samples, separated by at least 5 days, with detectable plasma CMV DNA after achievement of undetectable plasma CMV DNA in at least 2 consecutive samples, separated by at least 5 days, at any time after Day 1; as assessed by the central laboratory. Participants assessed for recurrence (n= 29, 27, 30) are the subset of the ITT-S who had at least 2 consecutive undetectable plasma CMV DNA results separated by at least 5 days, including early withdrawn qualified subjects. The median values are Kaplan-Meier estimates.|36 weeks|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.|||days||95% Confidence Interval|Median
2656721|NCT01611974|Secondary|Time to First Confirmed Undetectable Plasma CMV DNA Within 6 Weeks and at Any Time During The Study|Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. The time to event was defined as the time from first dose of study drug to first undetectable plasma CMV DNA within 6 weeks and at any time during the study, defined as the date of the first of at least 2 consecutive post-baseline, on-treatment undetectable results (<200 copies/mL) separated by at least 5 days; as assessed by the central laboratory. The median values are Kaplan-Meier estimates.|6 weeks after start of treatment, within 36 weeks of start of treatment|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.|||days||95% Confidence Interval|Median
2656722|NCT01611974|Secondary|Number of Participants With CMV Recurrence|Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. CMV recurrence was defined as achievement of undetectable plasma CMV DNA at any time after Day 1 in at least 2 consecutive samples separated by at least 5 days, followed by detectable plasma CMV DNA in at least 2 consecutive samples separated by at least 5 days (assessed by the central laboratory). For the analyses of CMV recurrence, the first of 2 consecutive confirmed undetectable plasma CMV DNA results had to be on-treatment. CMV DNA PCR values of ≥200 copies/mL were considered detectable. Participants assessed for recurrence (n= 29, 27, 30) are the subset of the ITT-S who had at least 2 consecutive undetectable plasma CMV DNA results separated by at least 5 days, including early withdrawn qualified subjects.|36 weeks|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.|||participants|||Number
2656723|NCT01611974|Primary|Number of Participants With a Treatment Emergent Adverse Event (TEAE).|Treatment-emergent adverse events are those events that occurred on or after study drug administration through 7 days after the last dose of study drug, or are events that occurred prior to study drug administration and recurred with increased severity after taking study drug through 7 days after the last dose of study drug.|25 weeks|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.|||participants|||Number
2656724|NCT01611974|Primary|Number of Participants With Confirmed Undetectable Plasma Cytomegalovirus (CMV) Within 6 Weeks|Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. This method was linear over 200-100,000 viral copies/mL with a lower limit of quantification (LLOQ) of 200 copies/mL. Results below LLOQ were considered undetectable. Confirmed undetectable plasma CMV DNA within 6 weeks was defined as 2 consecutive post-baseline, on-treatment undetectable results separated by >/= 5 days (assessed by the central laboratory). Samples were collected on Days 1 and 8, weekly during Weeks 2-6, and once in Weeks 8, 10, 12, 16, 20, 24 (treatment) and Weeks 1, 4, 8, 12 (follow-up). Permissible assessment windows were: Days 8-15 +/- 1 day; Weeks 3-4 +/- 2 days; Weeks 5-6 +/- 3 days; Weeks 8-12 +/- 4 days; Weeks 16-24 +/- 7 days (treatment) and Weeks 1-4 +/- 2 days; Weeks 8-12 +/- 4 days (follow-up).|6 weeks|The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.|||participants|||Number
2658120|NCT01600287|Other Pre-specified|Total Off CPB Propofol Used (mg/kg/hr|total dosage of propofol used on per kg body weight per hour basis in the period before and after cardiopulmonary bypass period.|6 hours(approx)||||mg per kg body weight per hour||Standard Deviation|Mean
2656725|NCT01611948|Primary|Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8|Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. Change = (Week 8 value - Week 0 value).|Week 0 and Week 8|Two participants in the matched placebo arm who completed the double blind portion of the trial were unable to be analyzed for change in Urinary CN-THCCOOH Level due to missing data at Week 0 and/or Week 8. One sample was missing source documentation while the other sample was too dilute to return a reliable measurement.|||ng/mg||Standard Deviation|Mean
2656726|NCT01611935|Secondary|Total Number of Complications|Variables will include intra-abdominal hypertension, open abdomen free days, ventilator-free days, ICU-free days, development of ARDS, development of renal failure, development of multiple organ failure, volume of crystalloid requirement within 48 hours post injury, and mortality.|30 days post injury|patients who did not survive the 48 hours were not included in the analysis|||Complications|||Number
2656727|NCT01611935|Secondary|Need for Vasopressor Requirement Vasopressor Requirement|total dose of vasopressors (epinephrine, norepinephrine, neosynephrine, etc) received by patient within 48 hours converted to norepinephrine equivalents (g) range in our study was from 0 gm to a max of 53 gm|48 hours following the initiation of therapy||||Norepinephrine equivalents (g)||Inter-Quartile Range|Median
2656728|NCT01611935|Primary|Number of Blood Products Transfused|Cumulative number of units of blood products, including packed red blood cells, plasma and platelets measured in liters|48 hours following the initiation of therapy||||Litre||Inter-Quartile Range|Median
2656729|NCT01611883|Secondary|Percent Change in Non-HDL-cholesterol From Baseline|Non-HDL-C levels measured at baseline and after 24 weeks of treatment.|Baseline and Week 24|Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.|||Percent Change||95% Confidence Interval|Least Squares Mean
2656730|NCT01611883|Secondary|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline|HDL-C levels measured at baseline and after 24 weeks of treatment.|Baseline and Week 24|Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.|||Percent Change||95% Confidence Interval|Least Squares Mean
2656731|NCT01611883|Secondary|Percent Change in Triglycerides From Baseline|Triglycerides levels measured at baseline and after 24 weeks of treatment.|Baseline and Week 24|Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.|||Percent Change||95% Confidence Interval|Least Squares Mean
2656732|NCT01611883|Secondary|Percent Change in Total Cholesterol (TC) From Baseline|TC levels measured at Baseline and after 24 weeks of treatment.|Baseline and Week 24|FAS defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.|||Percent Change||95% Confidence Interval|Least Squares Mean
2656733|NCT01611883|Secondary|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline|LDL-C levels measured at baseline and after 24 weeks of treatment|Baseline and Week 24|Full Analysis Set (FAS) defined as all enrolled participants who received at least 1 dose of study drug and baseline and follow-up data available.|||Percent Change||95% Confidence Interval|Least Squares Mean
2656734|NCT01611883|Secondary|Percentage of Participants With Changes in Diabetes Medications Due to Worsening of Diabetes|The percentage of participants who had changes to their medications used to treat their diabetes, other than small changes in insulin dosing (± 5 Units), were reported and summarized.|Up to 24 weeks|AST Population defined as all participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2656735|NCT01611883|Secondary|"Percentage of Participants With Adverse Event (AE) Exacerbation of Diabetes"|"The Investigator took into account a participant's index of blood glucose control, diabetes medications, and compliance to diet and exercise therapy to assess overall control of the participant's diabetes and to determine if the participant's diabetes worsened. Participants who experienced the AE Exacerbation of Diabetes  (verbatim term) were recorded."|up to 24 weeks|All Subjects Treated (AST) Population defined as all participants who received at least 1 dose of study drug.|||Percentage of Participants|||Number
2656736|NCT01611883|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline|Plasma glucose levels were assessed after an overnight fast at baseline and after 24 weeks of study drug administration.|Baseline and Week 24|Per Protocol Set defined as all randomized participants meeting inclusion criteria who were not excluded from the Full Analysis Set and were at least 75% compliant with study medication.|||mg/dL||95% Confidence Interval|Least Squares Mean
2656737|NCT01611883|Secondary|Change in Glycoalbumin From Baseline|Glycoalbumin is a blood marker used to assess blood glucose control over time and is reported as a percentage (%). Serum glycoalbumin levels were assessed at baseline and after 24 weeks of study drug administration.|Baseline and Week 24|Per Protocol Set defined as all randomized participants meeting inclusion criteria who were not excluded from the Full Analysis Set and were at least 75% compliant with study medication.|||Percent||95% Confidence Interval|Least Squares Mean
2656738|NCT01611883|Primary|Change in Glycated Hemoglobin (HbA1c) From Baseline|HbA1c is blood marker used to report average blood glucose levels over a prolonged period of time and is reported as a percentage (%). HbA1C was measured at baseline and after 24 weeks of study drug administration.|Baseline and Week 24|Per Protocol Set defined as all randomized participants meeting inclusion criteria who were not excluded from the Full Analysis Set and were at least 75% compliant with study medication.|||Percent||95% Confidence Interval|Least Squares Mean
2656739|NCT01611857|Secondary|Time to Progression in Phase II Dose Expansion|Defined as the time from first treatment until objective tumor progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|every 8 weeks until progressive disease, expected 18 months.|The analysis was performed on all participants (N = 34) in the Phase II portion of the study.|||months||95% Confidence Interval|Median
2656741|NCT01611857|Secondary|Progression Free Survival in Phase II Dose Expansion|Defined as the time from first treatment until objective tumor progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|every 8 weeks until treatment discontinuation, projected 18 months and then every 3 months thereafter up to 5 years from start of treatment.|The analysis was performed on an Intent-to-Treat basis (N = 34) for all participants in the Phase II portion of the study. Median follow-up was 15 months (3-21 months)|||months||95% Confidence Interval|Median
2656742|NCT01611857|Primary|The Incidence of Dose Limiting Toxicities (DLT) in Phase I Dose Escalation|Using a standard 3+3 design participants were enrolled in dose-escalating cohorts to determine the maximum tolerated dose (MTD) of tivantinib when given with FOLFOX (5-FU 400 mg/m^2, continuous IV 5-FU 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2). MTD is defined as the highest dose level at which no more than 1 of 6 patients experiences a DLT, assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.|14 Days (1 cycle)|Patients were assessed for DLT if they received at least 85% of the scheduled doses of study drugs in cycle 1. In the Tivantinib 120 mg cohort two participants were replaced due to missed drug. In the Tivantinib 360 mg cohort one patient was replaced due to an allergic reaction to oxaliplatin.|||participants|||Number
2656743|NCT01611792|Primary|Change From 11 Weeks to 6 Months in Numeric Pain Rating Scale (0-10 Points)|Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement|11 weeks and 6 months|Based on data reported and available|||units on a scale||Standard Deviation|Mean
2656744|NCT01611792|Primary|Change From Baseline to 6 Months in Numeric Pain Rating Scale (0-10 Points)|Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement|Baseline and 6 months|Based on data reported and available|||units on a scale||Standard Deviation|Mean
2656745|NCT01611792|Primary|Change From Baseline to 11 Weeks in Numeric Pain Rating Scale (0-10 Points)|Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement|Baseline and 11 weeks|Based on data reported and available|||units on a scale||Standard Deviation|Mean
2656746|NCT01611792|Primary|Change From 11 Weeks to 6 Months in Oswestry Disability Scale (0-100%)|Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement|11 Weeks and 6 Months|Based on data reported and available|||units on a scale||Standard Deviation|Mean
2656747|NCT01611792|Primary|Change From Baseline to 6 Months in Oswestry Disability Scale (0-100%)|Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement|Baseline and 6 Months|Based on data reported and available|||units on a scale||Standard Deviation|Mean
2656748|NCT01611792|Primary|Change From Baseline to 11 Weeks in Oswestry Disability Scale (0-100%)|Disability; Scale 0-100% Lower score is considered better/improved Negative value indicates improvement|Baseline and 11 weeks|Based on data reported and available|||units on a scale||Standard Deviation|Mean
2656749|NCT01611779|Secondary|Epworth Sleeping Scale (ESS)|0 to 24 (high value represents worse outcome)|Baseline, 1, 3, 12 months|Five (5) of 5 total subjects had data at baseline. Four (4) of 5 subjects had follow-up data at 1 week, 4 had follow-up data at 1 month, 4 had follow-up data at 3 months, and 2 had follow-up data at 12 months.|||units on a scale||Standard Deviation|Mean
2656750|NCT01611779|Secondary|Snoring Scale (VAS)|0 to 10 (high value represents worse outcome)|Baseline, 1 week; 1 month, 3 months, 12 months|Four (4) of 5 total subjects had data at baseline. Four (4) of 5 subjects had follow-up data at 1 week, 4 had follow-up data at 1 month, 3 had follow-up data at 3 months, and 2 had follow-up data at 12 months.|||units on a scale||Standard Deviation|Mean
2656751|NCT01611779|Secondary|Functional Outcomes and Sleep Questionnaire (FOSQ)|Questionnaire: 0 to 120 (high value represents better outcome)|Baseline, 1, 3, 12 months|Four (4) of 5 total subjects had data at baseline and follow-up data.|||units on a scale||Standard Deviation|Mean
2656752|NCT01611779|Secondary|Apnea Hypopnea Index|0 to >30/hour (high value represents worse outcome)|Baseline, 3, and 12 months|Three (3) of 5 subjects returned for 3 month follow-up and 2 of 5 subjects returned for the 12 month follow-up.|||events/hour||Standard Deviation|Mean
2656753|NCT01611779|Primary|Number of Participants Experiencing Complications|Patient will be examined by the investigator at each of the follow-up visits for the presence of any untoward or unintended response to the device.|3 months||||Participants|||Count of Participants
2656754|NCT01611779|Primary|Place the Implant and Stabilize the Tongue|Ability to place the implant and stabilize the tongue|Up to 7 weeks after the procedure||||Participants|||Count of Participants
2656755|NCT01611662|Primary|Pathological Complete Response Rate Following Chemotherapy Before Surgery|Pathological response rate following neoadjuvant chemotherapy was assessed by TNM staging at the time of radical cystectomy|Up to 5 years||||percentage of participants||95% Confidence Interval|Number
2656756|NCT01611571|Secondary|Change in FN BMD at 18 Months|Change in the Femoral Neck BMD at 18 month|18 months||||% change in TH BMD||Standard Deviation|Mean
2656757|NCT01611571|Secondary|New Morphometric Vertebral Fractures|counting the total new morphometric vertebral fractures as determined by x-ray from baseline through end of study|baseline through 18 months||||vertebral fracture|||Number
2656758|NCT01611571|Secondary|Change in Forearm Bone Density|change in 1/3 radius of forearm bone density as measured by DXA|baseline and 18 months||||% change in 1/3 Radius BMD||Standard Deviation|Mean
2656759|NCT01611571|Secondary|Change in Hip Bone Density|change in hip bone density measured by DXA|baseline and 18 months||||% change in TH BMD||Standard Deviation|Mean
2656760|NCT01611571|Primary|Change in Spine Bone Density|change in spine bone density at 18 months measured by DXA 18 and 24 months|18 months||||% change in LS BMD||Standard Deviation|Least Squares Mean
2656761|NCT01611558|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs), Drug-related SAEs, Drug-related AEs, AEs Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|From first dose to within 90 days of last study dose|All participants who received at least 1 dose of study drug|||Participants|||Number
2656762|NCT01611558|Secondary|Best Overall Response Rate (BORR)|BORR is defined as the percentage of participants who received treatment and, at any time during the study, had a best response of complete response or partial response, as confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) or Rustin criteria for patients with cancer antigen 125 (CA125) levels elevated to twice the upper limit of normal at baseline, divided by the total number of evaluable participants in the arm.|From first dose of study drug to unacceptable toxicity or progressive disease (to a maximum of 3 years)|All participants who received study drug. n=number of evaluable participants|||Percentage of participants||95% Confidence Interval|Number
2656763|NCT01611558|Primary|Number of Participants With Drug-related Adverse Events (AEs) of Grade 3 or Higher|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-threatening or disabling.|Day 1, first dose, to within 90 days of last dose in Induction Phase|All participants who received at least 1 dose of study drug|||Participants|||Number
2656764|NCT01611298|Secondary|Change in Immunoglobulin Levels|Changes from baseline to several time points during follow-up will be calculated.|up to 12 months|One participant was off study on day 68 and not included in this analysis. Six participants included in the analysis had at least one measurement at the follow-up time points. n=the number of participants with measurements for that time point.|||MG/DL||Inter-Quartile Range|Median
2656765|NCT01611298|Primary|Antibody Recall Response Rate|The proportion of participants with antibody recall response along with 95% confidence intervals will be calculated.|4 months|One participant was off study on day 68 and not included in this analysis.|||proportion of participants||95% Confidence Interval|Number
2656766|NCT01611259|Secondary|Influence of Rituximab Plus Lenalidomide on T-cell Subsets|T-cell subsets will be evaluated from EDTA blood in a central lab|Day 1, 14 and 28 of cycle 1 and day 1 of cycle 5|||||||
2656767|NCT01611259|Secondary|Number and Severity of Adverse Events|Safety of Rituximab (Mabthera®) plus Lenalidomide (Revlimid®) in this patient population|From treatment start until 28 days after last study treatment; expected study duration 24 months|||||||
2656768|NCT01611259|Primary|Objective Responses in Patients With MALT Lymphoma Presenting With Measureable Disease|The primary objective of this Phase II study is to evaluate the proportion of patients responding to Lenalidomide and Rituximab. In case of a response rate of < 40%, the combination is rejected as ineffective, while an active combination is defined at a minimum response rate of 60% based of findings with rituximab and lenalidomide mono-therapy.|40 weeks|48 patients were included into safety assessment, two of them received treatment but no efficacy assessment was available. Therefore, these two patients were neither included into Intention-to-treat nor Per-protocol efficacy analysis.|||Participants|||Count of Participants
2656769|NCT01611194|Secondary|Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (Per Protocol (PP) Population)|"RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-13 domain scores are presented separately. For RPQ-13 total scales, the scores were derived by totaling the corresponding question scores for each domain change from baseline."|Baseline to month 24 and month 36|PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed <20 sessions,1 because of illicit drug use during study.|||RPQ scores||Standard Deviation|Mean
2656770|NCT01611194|Secondary|Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (Per Protocol (PP) Population)|"RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. Analyses of the RPQ-3 domain scores are presented separately. For the RPQ-3 total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline."|Baseline to month 24 and month 36|PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed <20 sessions,1 because of illicit drug use during study.|||RPQ scores||Standard Deviation|Mean
2656789|NCT01611090|Secondary|Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment|The EORTC QLQ-CLL 16 is a 16-item disease specific module that comprises 5 domains of patient-reported health status important in CLL. There are three multi-item scales that include fatigue (2 items), treatment side effects and disease symptoms (8 items), and infection (4 items), and 2 single-item scales on social activities and future health worries. Responses are measured on a 4 point scale ranging from 1 (not at all) to 4 (very much).|Baseline to EOT (up to 2 years)|ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint. Here, 'n' signifies the number of participants analyzed for the specified symptoms.|||Units on the scale||Standard Deviation|Mean
2657086|NCT01609257|Secondary|Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Geometric Mean Titer (GMT)||Baseline, 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||titer||95% Confidence Interval|Geometric Mean
2656771|NCT01611194|Secondary|Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (Per Protocol (PP) Population)|"RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. For the RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline."|Baseline to month 24 and month 36|PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed <20 sessions,1 because of illicit drug use during study.|||RPQ scores||Standard Deviation|Mean
2656772|NCT01611194|Secondary|Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline: 24 and 36 Months (ITT Population)|"RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-13 domain scores are presented separately. For RPQ-13 total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline."|Baseline to 24 months and 36 months|"HBO2: 25 subs consented to 24 and 36 month f/u; 23 subs completed month 24 and 9 completed month 36; 2 subs missed 24 month visit.~Sham: 17 subs consented to 24 and 36 month f/u. 17 completed month 24 and 5 completed month 36"|||RPQ scores||Standard Deviation|Mean
2656773|NCT01611194|Secondary|Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline: 24 and 36 Months (ITT Population)|"RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. Analyses of the RPQ-3 domain scores are presented separately. For the RPQ-3 total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline."|Baseline to 24 months and 36 months|"HBO2: 25 subs consented to 24 and 36 month f/u; 23 subs completed month 24 and 9 completed month 36; 2 subs missed 24 month visit.~Sham: 17 subs consented to 24 and 36 month f/u. 17 completed month 24 and 5 completed month 36"|||RPQ scores||Standard Deviation|Mean
2656774|NCT01611194|Secondary|Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline: 24 and 36 Months (ITT Population)|"RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. For the RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline."|Baseline to 24 months and 36 months|"HBO2: 25 subs consented to 24 and 36 month f/u; 23 subs completed month 24 and 9 completed month 36; 2 subs missed 24 month visit.~Sham: 17 subs consented to 24 and 36 month f/u. 17 completed month 24 and 5 completed month 36"|||RPQ scores||Standard Deviation|Mean
2656775|NCT01611194|Secondary|Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (Per Protocol (PP) Population)|"RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-13 domain scores are presented separately. The scores were derived by totaling the corresponding question scores for each domain and change from baseline."|Baseline to week 13, Months 6 and 12|PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed <20 sessions,1 because of illicit drug use during study.|||RPQ scores||Standard Deviation|Mean
2656812|NCT01610791|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in Disease Activity|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. A reduction in DAS28 of at least 1.2 units was considered a clinically meaningful improvement.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||percentage of participants|||Number
2656776|NCT01611194|Secondary|Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (Per Protocol (PP) Population)|"RPQ/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. For the RPQ-3total scale, the scores were derived by totaling the corresponding question scores for each domain and change from baseline."|Baseline to week 13, Months 6 and 12|PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed <20 sessions,1 because of illicit drug use during study.|||RPQ scores||Standard Deviation|Mean
2656777|NCT01611194|Secondary|Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (Per Protocol (PP) Population)|"RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. For the RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline."|Baseline to week 13, Months 6 and 12|PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed <20 sessions,1 because of illicit drug use during study.|||RPQ scores||Standard Deviation|Mean
2656778|NCT01611194|Secondary|Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (ITT Population)|"RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-13 domain scores are presented separately. For RPQ-13 total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline."|Baseline to week 13, Months 6 and 12|1 subject in HBO2 missed the 6 month visit and 2 subjects missed the 12 month visit. 1 subject in the sham missed the week 13 visit and, 1 subject missed the month 6 visit and 3 subjects withdrew by month 12|||RPQ scores||Standard Deviation|Mean
2656779|NCT01611194|Secondary|Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (ITT Population)|"RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. Analyses of the RPQ-3 domain scores are presented separately. For the RPQ-3 total scales, the scores were derived by totaling the corresponding question scores for each domain and it's change from baseline."|Baseline to week 13, Months 6 and 12|1 subject in HBO2 missed the 6 month visit and 2 subjects missed the 12 month visit. 1 subject in the sham missed the week 13 visit and, 1 subject missed the month 6 visit and 3 subjects withdrew by month 12|||RPQ scores||Standard Deviation|Mean
2656780|NCT01611194|Secondary|Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (ITT Population)|"RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. The scores were derived by totaling the corresponding question scores for each domain and it's change from baseline."|Baseline to week 13, Months 6 and 12|1 subject in HBO2 missed the 6 month visit and 2 subjects missed the 12 month visit. 1 subject in the sham missed the week 13 visit and, 1 subject missed the month 6 visit and 3 subjects withdrew by month 12|||RPQ scores||Standard Deviation|Mean
2656813|NCT01610791|Secondary|Percentage of Participants by DAS28 Response Category|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 =low disease activity, DAS28 >3.2 to ≤5.1=moderate to high disease activity; DAS28 >5.1=high disease activity.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2656781|NCT01611194|Secondary|Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (Per Protocol (PP) Population)|"RPQ/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-3 and RPQ-13 domain scores are presented separately. For each of the RPQ-3, RPQ-13, and RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain."|Baseline|PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed <20 sessions,1 because of illicit drug use during study.|||RPQ scores||Standard Deviation|Mean
2656782|NCT01611194|Secondary|Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (ITT Population)|"RPQ/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from 0= Not experienced at to 4= A severe problem. Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-3 and RPQ-13 domain scores are presented separately. For each of the RPQ-3, RPQ-13, and RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain."|Baseline||||RPQ scores||Standard Deviation|Mean
2656783|NCT01611194|Primary|Summary of Study Intervention-Related Adverse Events|Safety was evaluated in-person during the first 3 months and at month 6, and via telephone follow-up calls at months 4, 5, and 7-12. Extended annual follow-up continued for up to 36 months through January 2016.|months 3, 6, 4, 5 and 7-12. Extended f/u up to 36 months||||Participants|||Count of Participants
2656784|NCT01611194|Primary|Summary of Treatment-Emergent Adverse Events|Safety was evaluated in-person during the first 3 months and at month 6, and via telephone follow-up calls at months 4, 5, and 7-12. Extended annual follow-up continued for up to 36 months through January 2016.|months 3, 6, 4, 5 and 7-12. Extended f/u up to 36 months||||Participants|||Count of Participants
2656785|NCT01611155|Secondary|Cycle 1 Acute Neuropathy as Measured by EORTC QLQ CIPN20 Motor Subscale (Items 37, 38, 41-45 and 49), and Autonomic Scale (Items 46, 47, 50)|The EORTC QLQ-CIPN20 motor and autonomic neuropathy scores will be calculated using the standard algorithm of EORTC QLQ-CIPN20 and transformed into a 0-100 point scale, where high scores meant less symptom burden. The changes of sensory neuropathy from baseline will be derived by subtracting the baseline score from the sensory neuropathy scores at each cycle of evaluation.|Up to 2 weeks|There were a few Venlafaxine patients who completed the items for the motor subscale but did not complete the items for autonomic subscale in cycle 1 and thus the number analyzed for each subscale is different on the venlafaxine arm.|||score on a scale||Standard Deviation|Mean
2656786|NCT01611155|Primary|Cycle 1 Sensory Neuropathy Score (Items 31-36, 39, 40 and 48) of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20|The EORTC QLQ-CIPN20 sensory neuropathy score will be calculated using the standard algorithm of EORTC QLQ-CIPN20 and transformed into a 0-100 point scale, where high scores meant less symptom burden. The changes of sensory neuropathy from baseline will be derived by subtracting the baseline score from the sensory neuropathy scores at each cycle of evaluation.|Up to 2 weeks|Patients who completed the (QLQ)-CIPN20 Sensory neuropathy items at cycle 1 are included in this analysis.|||score on a scale||Standard Deviation|Mean
2656787|NCT01611090|Secondary|Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Utility Score Scale at End of Treatment|The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1. High score indicating a high level of utility.|Baseline to EOT (up to 2 years)|ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint.|||Units on a scale||Standard Deviation|Mean
2656788|NCT01611090|Secondary|Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Visual Analog Scale at End of Treatment|The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health).|Baseline to EOT (up to 2 years)|ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint.|||Units on a scale||Standard Deviation|Mean
2656866|NCT01610700|Secondary|Change From Baseline in the Mean Fatigue Severity Scale Questionnaire Score at the End of Treatment|The Fatigue Severity Scale is a nine-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 0-6 scale (0= no fatigue and 6= severe fatigue). As such a decreased score indicates improvement, and a negative value indicates and improvement from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656790|NCT01611090|Secondary|Change From Baseline in EORTC QLQ-C30 Physical Functioning Score at End of Treatment|"EORTC QLQ-C30 Physical Functioning Score is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from 1 = not at all to 4 = very much. Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which was rated on a 7-point scale ranging from 1 = very poor to 7 = excellent. Lower scores indicate worsening. All scale and item scores were linearly transformed to be in range from 0-100. A higher score represents a higher (better) level of functioning, or a higher (worse) level of symptoms."|Baseline to EOT (up to 2 years)|ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint.|||Units on a scale||Standard Deviation|Mean
2656791|NCT01611090|Secondary|Change From Baseline in FACIT-Fatigue Scale at End of Treatment|FACIT-Fatigue is an instrument for use as a measure of the effect of fatigue in patients with cancer and other chronic diseases. Responses to the 13-item FACIT Fatigue Scale are reported on a 5‐point categorical response scale ranging from 0 (not at all) to 4 (very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Baseline to EOT (up to 2 years)|ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint.|||Units on a scale||Standard Deviation|Mean
2656792|NCT01611090|Secondary|Change From Baseline in Beta2 Microglobulin at End of Treatment (EOT)|Change from baseline in beta2 microglobulin at end of treatment at time of primary analysis was reported.|Baseline to EOT (Up to 2 years)|ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint.|||milligram per liter (mg/L)||Standard Deviation|Mean
2656793|NCT01611090|Secondary|Number of Participants Who Received Subsequent Antineoplastic Therapy|Number of participants who received subsequent antineoplastic therapy was reported.|Up to 5 years|Safety analysis set included all the randomized participants who received at least 1 dose of study drug or placebo.|||Participants|||Count of Participants
2656794|NCT01611090|Secondary|Number of Participants With Clinically Relevant Shifts in Disease-Related Symptoms|The disease-related symptoms included fatigue, weight loss, fevers, night sweats, abdominal discomfort/splenomegaly and anorexia.|From the date of randomization to disease progression (Up to 2 years)|ITT population included all participants randomized into the study regardless of treatment actually received.|||Participants|||Count of Participants
2656795|NCT01611090|Secondary|Median Time to Clinically Meaningful Improvement in FACIT-Fatigue Scale|Time to improvement is defined as the time interval (months) from randomization to the first observation of improvement. FACIT-Fatigue is an instrument for use as a measure of the effect of fatigue in patients with cancer and other chronic diseases. Responses to the 13-item FACIT Fatigue Scale are reported on a 5‐point categorical response scale ranging from 0 (not at all) to 4 (very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).|Up to 2 years|ITT population included all participants randomized into the study regardless of treatment actually received.|||Months||95% Confidence Interval|Number
2656796|NCT01611090|Secondary|Percentage of Participants With Sustained Hematologic Improvement|Sustained hematologic improvement was defined as hematological improvement that was sustained continuously for greater than or equal to (>=) 56 days without blood transfusion or growth factors: 1) Platelet counts greater than (>)100* 109/liter (L) if baseline less than or equal to (<=) 100*109/L or increase >= 50 percent (%) over baseline; 2) Hemoglobin >11 gram per deciliters (g/dL) if baseline <= 11 g/dL or increase >= 2 g/dL over baseline.|Up to 5 years|ITT population included all participants randomized into the study regardless of treatment actually received.|||Percentage of Participants|||Number
2656797|NCT01611090|Secondary|Percentage of Participants With Minimal Residual Disease (MRD)-Negative Response|MRD-negative response was defined as the percentage of participants who reach MRD negative disease status (less than 1 chronic lymphocytic leukemia [CLL] cell per 10,000 leukocytes) in either bone marrow or peripheral blood. All randomized participants were included in this analysis. Participants with missing MRD data were considered non-responders.|Up to 5 years|Intent to treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Percentage of participants|||Number
2656798|NCT01611090|Secondary|Overall Survival (OS)|OS was defined as the interval between the date of randomization and the date of death from any cause.|Up to 5 years|Intent to treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Months||95% Confidence Interval|Median
2656799|NCT01611090|Secondary|Overall Response Rate (ORR)|ORR defined as number of participants achieving a complete response (CR), complete response with incomplete marrow recovery (CRi), nodular partial response (nPR) or partial response (PR). IWCLL 2008 criteria: CR- No lymphadenopathy and hepatosplenomegaly, no constitutional symptoms, neutrophils >1.5*10^9/liter (L), platelets >100*10^9/L, Hgb >11 gram per deciliter (g/dL) and absolute lymphocyte count <4000/microliter (mcL); CRi- CR with incomplete recovery of bone marrow; nPR- participants meet criteria for CR, but the bone marrow biopsy shows B-lymphoid nodules, may represent a clonal infiltrate; PR-2 of the following when abnormal at baseline: >=50% decrease in ALC, >=50% decrease in sum products of up to 6 lymph nodes, >=50% decrease in enlargement of spleen or liver; and 1 of the following: neutrophils >1.5*10^9/L, Platelets >100*10^9/L and Hgb>11 g/dL or >=50% improvement over baseline in any of these; no new enlarged nodes or new hepatosplenomegaly.|Up to 5 years|Intent to treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Percentage of participants|||Number
2656881|NCT01610687|Secondary|Change From Baseline in Mean Intoxication 100 mm Visual Analogue Scale Scores at Week 18.|Intoxication levels were recorded on a Visual Analogue Scale, where 0 equals 'no intoxication' and 10 equals 'extreme intoxication'. A decrease in score indicates an improvement in intoxication levels.|18 weeks|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.|||units on a scale||Standard Deviation|Mean
2656800|NCT01611090|Primary|Progression-free Survival (PFS)|PFS was defined as the interval between the date of randomization and the date of disease progression or death, whichever was first reported. IWCLL 2008 criteria for PD: New enlarged nodes >1.5 cm, new hepatomegaly or splenomegaly, or other new organ infiltrates, bone lesion, ascites, or pleural effusion confirmed due to chronic lymphocytic leukemia (CLL); >=50% increase in existing lymph nodes; >=50% increase in enlargement of liver or spleen; >=50% increase from baseline in lymphocyte count (and to >=5*10^9/L) or >=50% increase from nadir count confirmed on >=2 serial assessments if absolute lymphocyte count (ALC) >=30,000 per microliter and lymphocyte doubling time is rapid, unless considered treatment-related lymphocytosis; new cytopenia (Hemoglobin b [Hgb] or platelets) attributable to CLL; and transformation to a more aggressive histology.|Up to 5 years|Intent to treat (ITT) population included all participants randomized into the study regardless of treatment actually received.|||Months||95% Confidence Interval|Median
2656801|NCT01610791|Primary|Percentage of Participants With Adverse Events|Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, AEs leading to withdrawal, AEs leading to death, and treatment-related AEs.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|Safety population: all participants who received at least one dose of study medication where at least one post-baseline assessment of safety was available.|||percentage of participants|||Number
2656802|NCT01610791|Secondary|Erythrocyte Sedimentation Rate (ESR)|ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. The change in ESR was determined as the difference in values from baseline at each visit.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||mm/hr||Standard Deviation|Mean
2656803|NCT01610791|Secondary|C-Reactive Protein (CRP)|CRP is an acute phase inflammatory marker. Levels of CRP increase with inflammation. The change in CRP was determined as the difference in values from baseline and at each visit.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||mg/dL||Standard Deviation|Mean
2656804|NCT01610791|Secondary|Patient Assessment of of Pain (VAS)|"The participant's assessment of their current level of pain was displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line was described as no pain and the right-hand extreme of the line (100 mm) was described as unbearable pain. The change in participant's perception of pain was determined as the difference in values from baseline at each visit."|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||mm||Standard Deviation|Mean
2656805|NCT01610791|Secondary|Physician's Global Assessment of Disease Activity (VAS)|"The physician's assessment of the participant's current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) was described as maximum disease activity. The Physician's Global Assessment of Disease Activity was completed by the Efficacy Assessor who could or could not be a physician. The change in Physician's Global Assessment of Disease Activity was determined as the difference in values from baseline at each visit."|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||mm||Standard Deviation|Mean
2656806|NCT01610791|Secondary|Patient Global Assessment of Disease Activity (VAS)|"The participant's overall assessment of their current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line was described as no disease activity (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) was described as maximum disease activity (maximum arthritis disease activity). The change in Patient Global Assessment of Disease Activity was determined as the difference in values from baseline at each visit."|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||mm||Standard Deviation|Mean
2656807|NCT01610791|Secondary|Health Assessment Questionnaire (HAQ)|HAQ was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple-choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The change in HAQ was determined as the difference in values from baseline at each visit.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||score on a scale||Standard Deviation|Mean
2656808|NCT01610791|Secondary|Swollen and Tender Joint Counts|The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). The following 28 joints were assessed by the physician for tenderness : metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). The change in SJC and TJC was determined as the difference in values from baseline at each visit.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||joints||Standard Deviation|Mean
2656809|NCT01610791|Secondary|Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria|The ACR response rates ACR20, ACR50, ACR70 are defined as ≥20%, ≥50%, ≥70% improvement, respectively, in: swollen joint count (SJC) (66 joints) and tender joint count (TJC) (68 joints) and 3 of the following 5 assessments: Patient assessment of pain (VAS); Patient global assessment of disease activity (VAS); Investigator global assessment of disease activity (VAS); and acute phase response (ESR or CRP)|Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2656810|NCT01610791|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.6)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Participants with a DAS28 score <2.6 were considered to have achieved remission.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants|||Number
2656811|NCT01610791|Secondary|Time to Achieve Clinically Meaningful Reduction in DAS28|A clinically meaningful improvement in DAS28 was defined as a reduction of at least 1.2 units. Time to achieving clinically meanigful improvement was calculated as the number of days from the first infusion to the first achievement of reduction of 1.2 units in DAS28.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||days||Standard Deviation|Mean
2656814|NCT01610791|Secondary|Disease Activity Score Based on 28-Joint Count (DAS28)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR; in millimeters per hour [mm/hour]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog assessment [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to less than or equal to (≤) 5.1=moderate to high disease activity; DAS28 >5.1=high disease activity.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population; n=number of participants assessed for the specified parameter at a given visit.|||units on a scale||Standard Deviation|Mean
2656815|NCT01610791|Secondary|Percentage of Participants With Lipid Elevations by Study Visit|Lipid panel assessed included TC, triglycerides, high-density lipoprotein (HDL), and LDL. Elevations were categorized as follows: LDL cholesterol: Optimal equals (=) less than (<)100 mg/dL, Near optimal=100-129 mg/dL, Borderline high 130-159 mg/dL, High 160-189 mg/dL, Very High ≥190 mg/dL; Total cholesterol: Desirable <200 mg/dL, Borderline high 200-239 mg/dL, High ≥240 mg/dL; HDL cholesterol: Low <40 mg/dL, High ≥60 mg/dL; Triglycerides: Normal <150 mg/dL, Borderline high 150-199 mg/dL, High 200-499 mg/dL, and Very high ≥500 mg/dL.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|Safety population; n (number) = number of participants assessed for the parameter at a given visit.|||percentage of participants|||Number
2656816|NCT01610791|Secondary|Change From Baseline Low-Density Lipoprotein (LDL) and Total Cholesterol (TC) to Highest Values|Levels of LDL and TC were measured in milligrams/deciliter (mg/dL). Change in LDL and TC were calculated as the value (highest) through Week 24, minus the value at Baseline.|Baseline through Week 24|Safety population|||mg/dL||Standard Deviation|Mean
2656817|NCT01610791|Secondary|Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) to Highest Value|The difference between baseline and highest values until Week 24 of ALT and AST. The values are measures as international units per liter (UI/L). The change was calculated as the value (highest) at a later timepoint up to Week 24, minus the value at Baseline.|Baseline through Week 24|Safety Population|||UI/L||Standard Deviation|Mean
2656818|NCT01610791|Secondary|Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study Visit|Percentage of participants discontinuing study treatment for any reason at every visit; causes of discontinuation in the summary included AEs, deaths, lost to follo-wup, AE and investigator decision and 'not determined'.|Weeks 4, 8, 12, 16, 20, and 24|All enrolled participants were included in the analysis|||percentage of participants|||Number
2656819|NCT01610752|Post-Hoc|Intervention Cost for Clinic|Clinic costs included interventionist time for training, session preparation, participant contacts, routine staff meetings, and scale and pedometer cost. Outcome measure only assessed in SmartMoms-Clinic and SmartMoms-Phone groups because the Physician Directed group did not receive any intervention. The US dollar cost was standard across each participant in each group so there is $0 standard deviation.|Approximately 6 months (from 1st trimester until delivery)||||US dollars||Standard Deviation|Mean
2656820|NCT01610752|Post-Hoc|Percentage of Days With Intervention Adherence|Adherence to the SmartMoms intervention was defined as the percentage of days participants weighed and recorded step counts in comparison to the expected number of days. Outcome measure only assessed in SmartMoms-Clinic and SmartMoms-Phone groups because the Physician Directed group did not receive any intervention.|Approximately 6 months (from 1st trimester until delivery)||||percentage of days||Standard Deviation|Mean
2656821|NCT01610752|Post-Hoc|Intervention Cost for Participant|Costs incurred for travel to and from treatment sessions and time spent with the counselor while accounting for session attendance and intervention adherence. Outcome measure only assessed in SmartMoms-Clinic and SmartMoms-Phone groups because the Physician Directed group did not receive any intervention.|Approximately 6 months (from 1st trimester until delivery)||||US dollars||Standard Deviation|Mean
2656822|NCT01610752|Secondary|Gestational Weight Gain Per Week|"per week is included to adjust for the different length of time between weight measurements"|Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)||||kilograms per week||Standard Error|Least Squares Mean
2656823|NCT01610752|Secondary|Total Gestational Weight Gain||Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)||||kilograms||Standard Error|Least Squares Mean
2656824|NCT01610752|Primary|Count of Women Who Have Excess Gestational Weight Gain|Count of pregnant women who gain more weight during pregnancy than is recommended by the Institute of Medicine Gestational Weight Gain guidelines|Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)||||Participants|||Count of Participants
2656825|NCT01610713|Secondary|Subject Global Opinion of Effect on Multiple Sclerosis at the End of Open-label Treatment|"A 7-point Likert-type scale was used, with the question: 'Please assess the status of your multiple sclerosis since entry into the study using the scale below' with the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse. The number of subjects that considered their condition to be better or much better at the end of open-label treatment is presented."|End of Part B (week 10)|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||participants|||Number
2656826|NCT01610713|Secondary|Change From Part A Mean Ten-metre Mobility Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The 10 Metre Mobility Score is a four point scale assessing a subject's level of mobility. The time taken to walk ten metres was measured for the subset of subjects who were able to walk. A decrease in time indicates and improvement.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||time (seconds)||Standard Deviation|Mean
2656882|NCT01610687|Secondary|Mean Number of Sprays of Study Medication Taken During the Last 6 Days of Treatment|A categorical summary was produced of the mean number of sprays per day during the last six days of treatment, and the mean number of sprays was rounded to the nearest whole number for categorisation.|up to 1206 days|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.|||sprays of study medication||Standard Deviation|Mean
2656827|NCT01610713|Secondary|Change From Part A Mean Bladder Problems Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in bladder problems from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656828|NCT01610713|Secondary|Change From Part A Mean Tremor Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in tremor from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656829|NCT01610713|Secondary|Change From Part A Mean Muscle Spasm Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates and improvement in spasms from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656830|NCT01610713|Secondary|Change From Part A Mean Pain Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement. As such, a negative value indicates an improvement in pain from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656831|NCT01610713|Secondary|Change From Part A Mean Spasticity Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement, as such a negative value indicates an imrovement in condition from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656832|NCT01610713|Secondary|Change From Part A Mean Feeling Upon Wakening 100 mm Visual Analogue Scale Score at the End of Open-Label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Feeling upon wakening was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656833|NCT01610713|Secondary|Change From Part A Mean Sleep Amount 100 mm Visual Analogue Scale Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Sleep amount was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656834|NCT01610713|Secondary|Incidence of Adverse Events as a Measure of Patient Safety|The number of patients who recorded an adverse event during the 4 week open-label period is presented.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|This analyses set included all patients who took GW-1000-02 during the open-label treatment period.|||participants|||Number
2656835|NCT01610713|Secondary|Change From Mean Part A Sleep Quality 100 mm Visual Analogue Scale Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Sleep quality scores were rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656883|NCT01610687|Primary|Incidence of Adverse Events as a Measure of Patient Safety|The number of patients who experienced an adverse event during the course of this extension study is presented|up to1206 days|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.|||participants|||Number
2656836|NCT01610713|Secondary|Change From Mean Part A Tremor Activities of Daily Living Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The tremor activities of daily living scale is a patient self-reported questionnaire which consists of 25 questions relating to the effect of tremors on different day-to-day activities, such as eating, drinking, threading a needle and tying a shoe. The ability to perform these tasks was scored on a scale of 0 (unable) to 3 (completely able). The summary parameter was the total score with a minimum of 0 (unable to perform tasks) and a maximum of 75 (completely able to perform tasks). As such, a positive value indicates an improvement in condition from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656837|NCT01610713|Secondary|Change From Mean Part A Total Bladder Control Questionnaire Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The total bladder control test score was the sum score from fifteen questions, which were each scored on a 0-2 scale (one question 0-3), where 0 = good and 2/3 = bad. Ten questions were related to bladder symptoms and control and five were related to the effects on the patient's life. The summary parameters were the total score with a minumum possible score of 0 and a maximum possible score of 31. A decrease in score indicates an improvement, as such a negative value indicates an improvement in condition from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656838|NCT01610713|Secondary|Change From Mean Part A Nine Hole Peg Test Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Nine-Hole Peg Test is a board with nine holes into which subjects have to insert nine pegs and is designed to test dexterity and coordination. Scores range from 0 (good) to 60 (bad). As such a decrease in score indicates an improvement, and a negative value indicates an improvement from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656839|NCT01610713|Secondary|Change From Mean Part A Total 28-item General Health Questionnaire Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The 28-item General Health Questionnaire is a self-reported questionnaire for the detection of non-psychotic mental disorders (anxiety and depression) in the community and primary care settings. A series of four subscale scores (ranging from 0 [good] to 21 [bad]) were combined to give a total score, which ranged from 0 (good) to 84 (bad). As such, a negative value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656840|NCT01610713|Secondary|Change From Mean Part A Rivermead Mobility Index Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Rivermead Mobility Index is a measure of subject self-mobilisation and was developed to enable rehabilitation professionals to document the effect(s) of interventions. This consisted of 15 questions relating to the dexterity and/or mobility of the patient. Each question had a 'yes' / 'no' answer which was scored as yes=1 no=0. The summary parameter was the total for the 15 questions, with a maximum score of 15. An increased score indicates improvement. As such, a positive value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656841|NCT01610713|Secondary|Change From Mean Part A Fatigue Severity Scale Questionnaire Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Fatigue Severity Scale is a nine-item questionnaire developed to assess the level of fatigue due to neurological disease, were each assessed on a 0-6 scale (0= no fatigue and 6= severe fatigue). As such a decreased score indicates improvement, and a negative value indicates and improvement from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656842|NCT01610713|Secondary|Change From Mean Part A Beck's Depression Inventory (BDI-II) Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The BDI-II was a 21-question multiple choice self-reported inventory. Subjects' responses to the 21 questions were assigned a score ranging from zero (good) to three (bad), indicating the severity of the symptom. The sum of all BDI-II question scores indicated the severity of depression; score range 0-63. A decrease in score indicates an improvement in condition. As such, a negative value indicates in improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656884|NCT01610596|Secondary|Overall Disease Severity Score (Improvement)|"The proportion of subjects rated a improved for ODS at Day 8 and Day 15. Improvement is defined as at least a two (2) grade decrease in severity score relative to baseline using a five-point scale ranging from 0 = clear to 4 = severe/very severe."|Days 8 and 15||||percentage of participants|||Number
2657114|NCT01609062|Secondary|6-minute Walk Test (6MWT)|Change from baseline to Week 12, 24, and 52 as measured in distance walked (meters) in 6MWT.|Baseline, Week 12, 24, and 52|Modified Intent-to-Treat Analysis Set|||meters||Standard Deviation|Mean
2656843|NCT01610713|Secondary|Change From Mean Part A Total Adult Memory and Information Processing Battery Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Adult Memory and Information Processing Battery test comprises six sub-sections which assess cognition and mental alertness. These include immediate and delayed story recall, word-list learning, copying a complex figure followed by its immediate reproduction, design learning, and information processing (parts A and B). The sum score for each section gave the total score which ranged from 1 (bad) to 105 (good). As such, a positive value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656844|NCT01610713|Secondary|Change From Mean Part A Barthel Activities for Daily Living Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. The ability to undertake the different daily activities was assessed on scales of 0-1 to 3, with 0= poorest outcome and upper scores= best outcome. The total score was the sum of scores for each item; minimum score= 0, maximum score= 20. A change of two or greater in the total score indicating a clinically relevant change. A positive value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656845|NCT01610713|Secondary|Change From Mean Part A Short Orientation Memory Concentration Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Short Orientation-Memory-Concentration test is a questionnaire designed to measure orientation, concentration on simple tasks and learning and recall of simple information. The test consists of six items, such as 'what year is it now?' and 'count backwards from 20 to 1'. Each item was scored between 0 (maximum number of errors) and three-10 (best score; no errors), with a point deducted for each error. The summary parameter was the total score from the sum of scores for each item, with an overall possible maximum score of 28 (no errors). Scores over 20 are considered 'normal'. As such, an increased score indicates an improvement, and a positive value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656846|NCT01610713|Secondary|Change From Mean Part A Ashworth Scale Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition. As such, a negative value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656847|NCT01610713|Secondary|Change From Mean Part A Reading Visual Acuity Test Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. Assessment of reading visual acuity was made using a standard reading chart. Scores could range from 1 (good) to 20 (bad), indicating good and poor eyesight, respectively. As such, a negative value from baseline indicates an improvement in eyesight.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656848|NCT01610713|Secondary|Change From Mean Part A Care-Giver Strain Index Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Caregiver Strain Index is a 13-item questionnaire designed to detect strain in those that care for subjects. Carers were asked if they found certain situations difficult (i.e. work adjustments, family adjustment, emotional adjustments, physical effort). Each question was scored zero (answered no) or one (answered yes), and was recorded for each of the 13 questions. The summary parameter was the total score, which was the sum score of the 13 questions, giving a minimum possible score of 0 (no strain) and maximum possible score of 13 (maximum possible strain). As such a negative value from baseline indicates an improvement in caregiver strain.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656867|NCT01610700|Secondary|Change From Baseline in the Mean Beck's Depression Inventory (BDI-II) Score at the End of Treatment|This was a 21-question multiple choice self-report inventory. Subjects' responses to the 21 questions were assigned a score ranging from zero (good) to three (bad), indicating the severity of the symptom. The sum of all BDI-II question scores indicated the severity of depression; score range 0-63. A decrease in score indicates an improvement in condition. As such, a negative value indicates in improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2658121|NCT01600287|Other Pre-specified|Total Fentanyl Used (µg/kg)|total fentanyl used in the whole duration of surgery on per kg body weight basis|8 hours(approx)||||microgram per kg body weight||Standard Deviation|Mean
2656849|NCT01610713|Secondary|Change From Mean Part A Guy's Neurological Disability Scale Score at the End of Open-label Treatment|This was achieved by measuring the change in the mean Part A study score (during six weeks of therapy) to the mean score at the end of 4 weeks of open-label treatment with GW-1000-02. The Guy's Neurological Disability Scale has 12 separate categories which include cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and 'others'. Each category consists of a series of questions, which are scored on a 0 to 5 scale, with 0 being indicative of a better outcome and 5 being indicative of a worse outcome. The total Guy's Neurological Disability Scale score is the unweighted sum from the 12 categories with a minimum score of 0 and maximum of 60. A negative value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656850|NCT01610713|Primary|Change From Mean Part A Primary Impairment Visual Analogue Scale Score (After 6 Weeks) at the End of Four Weeks of Open-label Treatment (10 Weeks Total)|This was achieved by measuring the change in the Part A study score (mean of all scores during the last two weeks of six weeks of double-blind therapy) in the severity of the primary impairment (mean of all scores during the last two weeks of four weeks of open-label therapy), a composite score from one of five multiple sclerosis symptom categories that subjects nominated as their most severe symptom. The severity scores were recorded using a 100 mm Visual Analogue Scale, where 0 = no problem and 100 = very bad. As such, a decrease in score indicates an improvement and a negative value indicates an improvement in score from baseline.|End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded.|||units on a scale||Standard Deviation|Mean
2656851|NCT01610700|Secondary|Change From Baseline in the Mean Total Adult Memory and Information Processing Battery Test Score at the End of Treatment|The Adult Memory and Information Processing Battery test comprises six sub-sections which assess cognition and mental alertness. These include immediate and delayed story recall, word-list learning, copying a complex figure followed by its immediate reproduction, design learning, and information processing (parts A and B). The sum score for each section gave the total score which ranged from 1 (bad) to 105 (good). As such, a positive value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656852|NCT01610700|Secondary|Change From Baseline in the Mean Guy's Neurological Disability Scale Score at the End of Treatment|The Guy's Neurological Disability Scale has 12 separate categories which include cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and 'others'. Each category consists of a series of questions, which are scored on a 0 to 5 scale, with 0 being indicative of a better outcome and 5 being indicative of a worse outcome. The total Guy's Neurological Disability Scale score is the unweighted sum from the 12 categories with a minimum score of 0 and maximum of 60. A negative value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656853|NCT01610700|Secondary|Change From Baseline in the Mean Care-Giver Strain Index Score at the End of Treatment|The Caregiver Strain Index is a 13-item questionnaire designed to detect strain in those that care for subjects. Carers were asked if they found certain situations difficult (i.e. work adjustments, family adjustment, emotional adjustments, physical effort). Each question was scored zero (answered no) or one (answered yes), and was recorded for each of the 13 questions. The summary parameter was the total score, which was the sum score of the 13 questions, giving a minimum possible score of 0 (no strain) and maximum possible score of 13 (maximum possible strain). As such a negative value from baseline indicates an improvement in caregiver strain.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656854|NCT01610700|Secondary|Change From Baseline in the Mean Reading Visual Acuity Test Score at the End of Treatment|Assessment of reading visual acuity was made using a standard reading chart. Scores could range from 1 (good) to 20 (bad), indicating good and poor eyesight, respectively. As such, a negative value from baseline indicates an improvement in eyesight.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656855|NCT01610700|Secondary|Change From Baseline in the Mean Short Orientation-Memory-Concentration Test at the End of Treatment|The Short Orientation-Memory-Concentration test is a questionnaire designed to measure orientation, concentration on simple tasks and learning and recall of simple information. The test consists of six items, such as 'what year is it now?' and 'count backwards from 20 to 1'. Each item was scored between 0 (maximum number of errors) and three-10 (best score; no errors), with a point deducted for each error. The summary parameter was the total score from the sum of scores for each item, with an overall possible maximum score of 28 (no errors). Scores over 20 are considered 'normal'. As such, an increased score indicates an improvement, and a positive value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656868|NCT01610700|Secondary|Change From Baseline in Modified Ashworth Scale Score at the End of Treatment|All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition. As such, a negative value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656856|NCT01610700|Secondary|Change From Baseline in the Mean Barthel Activities for Daily Living Scale Score at the End of Treatment|The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. The person receives a score based on whether they have received help while doing the task. The ability to undertake the 10 different daily activities was assessed on scales of 0-1, 0-2 or 0-3, with 0 indicative of the poorest outcome and the highest possible score indicative of the best outcome. The summary parameter was the total score for each of the ten items, with a minimum possible score of 0 and a maximum possible score of 20. An increased score indicates an improvement, with a change of two or greater in the total score indicating a clinically relevant change. A positive value therefore indicates an improvement from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656857|NCT01610700|Secondary|Change From Baseline in the Mean Feeling Upon Wakening 100 mm Visual Analogue Scale Score at the End of Treatment|Sleep amount was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656858|NCT01610700|Secondary|Change From Baseline in the Mean Sleep Amount 100 mm Visual Analogue Scale Score at the End of Treatment|Sleep amount was rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|Baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656859|NCT01610700|Secondary|Change From Baseline in the Mean Sleep Quality 100 mm Visual Analogue Scale Score at the End of Treatment|Sleep quality scores were rated using a 100 mm visual analogue scale where 0 = best and 100 = worst. As such, a negative value is indicative of an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656860|NCT01610700|Secondary|Change From Baseline in the Mean Ten-metre Mobility Score at the End of Treatment|The 10 Metre Mobility Score is a four point scale assessing a subject's level of mobility. The time taken to walk ten metres was measured for the subset of subjects who were able to walk. A decrease in time indicates an improvement in condition.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||time (seconds)||Standard Deviation|Mean
2656861|NCT01610700|Secondary|Change From Baseline in the Mean Tremor Activities of Daily Living Scale Score at the End of Treatment|The tremor activities of daily living scale is a patient self-reported questionnaire which consists of 25 questions relating to the effect of tremors on different day-to-day activities, such as eating, drinking, threading a needle and tying a shoe. The ability to perform these tasks was scored on a scale of 0 (unable) to 3 (completely able). The summary parameter was the total score with a minimum of 0 (unable to perform tasks) and a maximum of 75 (completely able to perform tasks). As such, a positive value indicates an improvement in condition from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656862|NCT01610700|Secondary|Change From Baseline in the Mean Total Bladder Control Test Score at the End of Treatment|The total bladder control test score was the sum score from fifteen questions were each scored on a 0-2 scale (one question 0-3), where 0 = good and 2/3 = bad. Ten questions were related to bladder symptoms and control and five were related to the effects on the patient's life. The summary parameters were the total score with a minumum possible score of 0 and a maximum possible score of 31. A decrease in score indicates an improvement, as such a negative value indicates an improvement in condition from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656863|NCT01610700|Secondary|Change From Baseline in the Mean Nine-hole Peg Test Score at the End of Treatment|The Nine-Hole Peg Test is a board with nine holes into which subjects have to insert nine pegs and is designed to test dexterity and coordination. Scores range from 0 (good) to 60 (bad). As such a decrease in score indicates an improvement, and a negative value indicates an improvement from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656864|NCT01610700|Secondary|Change From Baseline in the Mean Total 28-item General Health Questionnaire Score at the End of Treatment|The 28-item General Health Questionnaire is a self-reported questionnaire for the detection of non-psychotic mental disorders (anxiety and depression) in the community and primary care settings. A series of four subscale scores (ranging from 0 [good] to 21 [bad]) were combined to give a total score, which ranged from 0 (good) to 84 (bad). As such, a negative value indicates an improvement in score from baseline.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656865|NCT01610700|Secondary|Change From Baseline in the Mean Rivermead Mobility Index Score at the End of Treatment|The Rivermead Mobility Index is a measure of subject self-mobilisation and was developed to enable rehabilitation professionals to document the effect(s) of interventions. This consisted of 15 questions relating to the dexterity and/or mobility of the patient. Each question had a 'yes' / 'no' answer which was scored as yes=1 no=0. The summary parameter was the total for the 15 questions, with a maximum score of 15. An increased score indicates improvement. As such, a positive value indicates an improvement in score from baseline.|Baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656869|NCT01610700|Secondary|Subject Global Opinion of Effect on Multiple Sclerosis at the End of Treatment|"A 7-point Likert-type scale was used, with the question: 'Please assess the status of your multiple sclerosis since entry into the study using the scale below' with the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse. At Visit 2 (Baseline) patients wrote a brief description of their Multiple sclerosis which was used at end of treatment to aid their memory regarding their symptoms at study start. The number of subjects that considered their condition to be better or much better at the end of treatment is presented."|6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||participants|||Number
2656870|NCT01610700|Secondary|Change From Baseline in Bladder Problems Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656871|NCT01610700|Secondary|Change From Baseline in Tremor Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656872|NCT01610700|Secondary|Change From Baseline in Muscle Spasm Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656873|NCT01610700|Secondary|Change From Baseline in Pain Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores were recorded using a 100 mm Visual Analogue Scale. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656874|NCT01610700|Secondary|Change From Baseline in Spasticity Visual Analogue Scale Score at the End of 6 Weeks of Treatment|Severity scores over the last 24 hours were recorded using a 100 mm Visual Analogue Scale on one nominated day each week. Scores ranged from 0 = no problem to 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656875|NCT01610700|Primary|Change From Baseline in Composite Primary Impairment Visual Analogue Scale Score at the End of 6 Weeks of Treatment|This was achieved by measuring the change from baseline after six weeks of therapy in the severity of the primary impairment, a composite score from one of five Multiple Sclerosis symptom categories that subjects nominated as their most severe symptom. The severity scores were recorded using a 100 mm Visual Analogue Scale, where 0 = no problem and 100 = very bad. A decrease in score indicates an improvement.|baseline and 6 weeks|All subjects randomised who received at least one dose of study medication and had any on-treatment evaluable efficacy data recorded were included in the analysis.|||units on a scale||Standard Deviation|Mean
2656876|NCT01610687|Secondary|Change From Baseline in the Mean Bladder Problems 100 mm Visual Analogue Scale Score at Week 18|A clinical assessment of bladder problems was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no bladder problems and 100 = worst possible bladder problems. A decrease in score indicates an improvement.|18 weeks|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.|||units on a scale||Standard Deviation|Mean
2656877|NCT01610687|Secondary|Change From Baseline in the Mean Tremor 100 mm Visual Analogue Scale Score at Week 18|A clinical assessment of tremor was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no tremor and 100 = worst possible tremor. A decrease in score indicates an improvement.|week 18|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.|||units on a scale||Standard Deviation|Mean
2656878|NCT01610687|Secondary|Change From Baseline in the Mean Spasticity 100 mm Visual Analogue Scale Score at Week 18|A clinical assessment of spasticity was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no spasticity and 100 = worst possible spasticity. A decrease in score indicates an improvement.|week 18|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.|||units on a scale||Standard Deviation|Mean
2656879|NCT01610687|Secondary|Change From Baseline in the Mean Pain 100 mm Visual Analogue Scale Score at Week 18|A clinical assessment of pain was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no pain and 100 = worst possible pain. A decrease in score indicates an improvement.|week 18|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.|||units on a scale||Standard Deviation|Mean
2656880|NCT01610687|Secondary|Investigator Assessed Global Severity Score at Week 18|The investigator rated the global severity of the subject's primary condition since entry into the study using a five-point verbal rating scale-5: 1=much worse, 2=worse, 3=no change, 4=better, 5=much better. The number of patients which were considered better or much better (scores 4 and 5) at week 18 of the study better is presented.|week 18|All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.|||participants|||Number
2656885|NCT01610596|Secondary|Clinical Signs and Symptoms of Psoriasis|"The proportion of subjects rated a treatment success for each of the clinical signs and symptoms of psoriasis: scaling, erythema, plaque elevation and pruritis. Treatment success is defined as a score of 0 or 1 on a five-point scale ranging from 0 = clear to 4 = severe/very severe."|Days 8 and 15|Analysis shown is based on the ITT population.|||percentage of participants|||Number
2656886|NCT01610596|Secondary|Percent Body Surface Area|Changes in percent BSA with active psoriasis in the Treatment Area|Baseline, Days 8 and 15|Analysis shown is based on the ITT population.|||Change in %BSA||Standard Deviation|Mean
2656887|NCT01610596|Primary|Overall Disease Severity Score (Success)|"Overall disease severity (ODS) will be recorded at baseline, Day 8, and Day 15 on a 0 (clear) to 4 (severe/very severe) point scale. The primary efficacy endpoint was the percentage of subjects with ODS treatment success at end of treatment (Day 15). Success was defined as a grade of 0 or 1 on the ODS scale."|Day 15|Analysis shown is the Intent-to-treat (ITT) population, defined as all enrolled participants who were randomized and applied at least one dose of the test article.|||percentage of participants|||Number
2656888|NCT01610570|Other Pre-specified|Number of Participants With Dose Limiting Toxicity (DLT)|Hematologic DLT was defined as any grade 4 neutropenia (<500/µL) or thrombocytopenia (<25,000/µL) refractory to platelet transfusion, any grade 2 bleeding not promptly (within 6 h of appropriate intervention) corrected with blood product support. Non-hematologic DLT's were any mithramycin-related grade ≥3 toxicity with the exception of grade 3 nausea, vomiting, or diarrhea that was controlled by symptomatic treatment within 72h, asymptomatic grade 3 elevation of serum transaminases that return to ≤grade 1 within 14 days of completing mithramycin administration, and asymptomatic electrolyte abnormalities that are correctable to grade2 or less within 48h.|Cycle 1 of therapy (or 28 days)|Hepatotoxicity|||Participants|||Count of Participants
2656889|NCT01610570|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Analysis was performed using the Phoenix 6.3 with WinNonlin noncompartmental method.|Prior to dose 1, 3hrs after dose 1 infusion, prior to end of 6hr infusion, 0.25, 0.5, 1,2,3,4,5, & 7hr post infusion, & between 9 & 12hr completion of 1st dose infusion. Trough & end of infusion samples obtained w/day 2,4,&7 doses & 24hr after day 7 dose|After dose-limiting hepatotoxicity was observed in the 1st 2 adult patients (pts), the protocol was subsequently amended to allow PK analysis prior to and at the completion of the first dose during cycle 1 on both the ph 1 & 2 portions of the trial in consenting pts. PK sampling was not mandatory, thus not all pts (i.e. 4/8 pts) had PK analysis.|||L||Standard Deviation|Mean
2656890|NCT01610570|Secondary|Clearance at Steady State (CLss)|The CL is a quantitative measure of the rate at which a drug substance is removed from the body. Analysis was performed using the Phoenix 6.3 with WinNonlin noncompartmental method.|Prior to dose 1, 3hrs after dose 1 infusion, prior to end of 6hr infusion, 0.25, 0.5, 1,2,3,4,5, & 7hr post infusion, & between 9 & 12hr completion of 1st dose infusion. Trough & end of infusion samples obtained w/day 2,4,&7 doses & 24hr after day 7 dose|After dose-limiting hepatotoxicity was observed in the 1st 2 adult patients (pts), the protocol was subsequently amended to allow PK analysis prior to and at the completion of the first dose during cycle 1 on both the ph 1 & 2 portions of the trial in consenting pts. PK sampling was not mandatory, thus not all pts (i.e. 4/8 pts) had PK analysis.|||L/h||Standard Deviation|Mean
2656891|NCT01610570|Secondary|Area Under the Curve for the Dosing Interval (AUCtau)|AUCtau is AUC for the dosing interval. Analysis was performed using the Phoenix 6.3 with WinNonlin noncompartmental method.|Prior to dose 1, 3hrs after dose 1 infusion, prior to end of 6hr infusion, 0.25, 0.5, 1,2,3,4,5, & 7hr post infusion, & between 9 & 12hr completion of 1st dose infusion. Trough & end of infusion samples obtained w/day 2,4,&7 doses & 24hr after day 7 dose|After dose-limiting hepatotoxicity was observed in the 1st 2 adult patients (pts), the protocol was subsequently amended to allow PK analysis prior to and at the completion of the first dose during cycle 1 on both the ph 1 & 2 portions of the trial in consenting pts. PK sampling was not mandatory, thus not all pts (i.e. 4/8 pts) had PK analysis.|||h*ng/mL||Standard Deviation|Mean
2656892|NCT01610570|Secondary|Area Under the Curve Extrapolated to Infinity (AUCinf)|AUC is a measure of the serum concentration of mithramycin over time. It is used to characterize drug absorption. Analysis was performed using the Phoenix 6.3 with WinNonlin noncompartmental method.|Prior to dose 1, 3hrs after dose 1 infusion, prior to end of 6hr infusion, 0.25, 0.5, 1,2,3,4,5, & 7hr post infusion, & between 9 & 12hr completion of 1st dose infusion. Trough & end of infusion samples obtained w/day 2,4,&7 doses & 24hr after day 7 dose|After dose-limiting hepatotoxicity was observed in the 1st 2 adult patients (pts), the protocol was subsequently amended to allow PK analysis prior to and at the completion of the first dose during cycle 1 on both the ph 1 & 2 portions of the trial in consenting pts. PK sampling was not mandatory, thus not all pts (i.e. 4/8 pts) had PK analysis.|||h*ng/mL||Standard Deviation|Mean
2656893|NCT01610570|Secondary|Half-Life (HL) of Mithramycin|Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half. Analysis was performed using the Phoenix 6.3 with WinNonlin noncompartmental method.|Prior to dose 1, 3hrs after dose 1 infusion, prior to end of 6hr infusion, 0.25, 0.5, 1,2,3,4,5, & 7hr post infusion, & between 9 & 12hr completion of 1st dose infusion. Trough & end of infusion samples obtained w/day 2,4,&7 doses & 24hr after day 7 dose|After dose-limiting hepatotoxicity was observed in the 1st 2 adult patients (pts), the protocol was subsequently amended to allow PK analysis prior to and at the completion of the first dose during cycle 1 on both the ph 1 & 2 portions of the trial in consenting pts. PK sampling was not mandatory, thus not all pts (i.e. 4/8 pts) had PK analysis.|||hours||Standard Deviation|Mean
2656894|NCT01610570|Secondary|Maximum Plasma Concentration (Cmax) of Mithramycin Using Non-Compartmental Methods|The maximum observed analyte concentration in serum was reported. Mithramycin plasma concentrations were measured using high-performance liquid chromatography tandem mass spectroscopic method, and analysis was performed using the Phoenix 6.3 with WinNonlin noncompartmental method.|Prior to dose 1, 3hrs after dose 1 infusion, prior to end of 6hr infusion, 0.25, 0.5, 1,2,3,4,5, & 7hr post infusion, & between 9 & 12hr completion of 1st dose infusion. Trough & end of infusion samples obtained w/day 2,4,&7 doses & 24hr after day 7 dose|After dose-limiting hepatotoxicity was observed in the 1st 2 adult patients (pts), the protocol was subsequently amended to allow PK analysis prior to and at the completion of the first dose during cycle 1 on both the ph 1 & 2 portions of the trial in consenting pts. PK sampling was not mandatory, thus not all pts (i.e. 4/8 pts) had PK analysis.|||ng/mL||Standard Deviation|Mean
2656895|NCT01610570|Secondary|Number of Participants With a Change in Tumor Burden Measured by the World Health Organization (WHO) Criteria|Per the WHO criteria, progressive disease is a 25% increase in tumor lesions, or the appearance of any new measureable or non-measureable tumor lesions. Partial response is ≥50% decrease in tumor lesions. Complete response is disappearance of all tumor lesions. Stable disease is 50% decrease in tumor lesions compared to baseline, nor 25% increase compared with nadir.|≥4 weeks from baseline|Changes in tumor burden was not evaluated for patients on the phase I portion of the study (patients 4 and 6). Changes in tumor burden was evaluated on the phase II portion of the study only for patients 1, 2, 3, 5, 7, and 8.|||Participants|||Count of Participants
2656896|NCT01610570|Secondary|Number of Participants With a Change in Tumor Burden Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)|Measurable disease were to be quantified using volumetric magnetic resonance imaging analysis per the RECIST, measuring soft tissue disease. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progressions). Stable disease (SD) is neither shrinkage to qualify for PR nor sufficient increase to qualify for PD.|≥4 weeks from baseline|Changes in tumor burden was not evaluated for patients on the phase I portion of the study (patients 4 and 6). Changes in tumor burden was evaluated on the phase II portion of the study only for patients 1, 2, 3, 5, 7, and 8.|||Participants|||Count of Participants
2656897|NCT01610570|Secondary|Count of Participants With NR0B1 Expression in Tumor Biopsies|Biopsies were to be obtained in adult patients who have disease that could be safely biopsied.|Pre-treatment and day 4 (+/- 1 day)|This outcome measure was not done because none of the adult patients on this study had disease that was deemed accessible.||||||
2656898|NCT01610570|Secondary|Time to Progression (TTP)|TTP is defined as the number of days from enrollment until disease progression, death because of treatment complications, resection of measureable tumor, or last patient follow-up, whichever comes first, assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progressions). Stable disease (SD) is neither shrinkage to qualify for PR nor sufficient increase to qualify for PD.|At date of progression, an average of 56 days|TTP was not evaluated for patients on the phase I portion of the study (patients 4 and 6). TTP was evaluated on the phase II portion of the study only for patients 1, 2, 3, 5, 7, and 8.|||Days|||Number
2656899|NCT01610570|Secondary|Objective Response Rate (Complete Response (CR) + Partial Response (PR))|Objective response in children and adolescents with Ewings sarcoma - friend leukemia integration 1 transcription factor to mithramycin is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the diameters of target lesions.|1-2 months|This is a phase II objective, thus phase I groups are not shown here.|||participants|||Number
2656900|NCT01610570|Primary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events. For a detailed list of serious and non-serious adverse events see the adverse event module.|95 days||||Participants|||Count of Participants
2656901|NCT01610570|Primary|Maximum Tolerated Dose (MTD) of Mithramycin|The MTD will be the maximum dose at which fewer than one-third of patients experience Dose Limiting Toxicity (DLT) (i.e., non-hematologic toxicity and hematologic toxicity) during cycle 1 (or 28 days) of therapy.|Cycle 1 of therapy (or 28 days)|MTD was not determined because based on pharmacokinetic data, a clinically relevant dose could not be obtained with the dose strategy. A minimum of 3 patients must be enrolled on a dose level to complete that dose level. Because only 2 patients were enrolled on phase I portion of the trial, dose level 1 was not completed and an MTD was not reached.||||||
2656902|NCT01610557|Secondary|Change in Central Retinal Thickness Assessed by Optical Coherence Tomography (OCT) Central Subfield Mean Thickness (CSMT) From Baseline to 36 Weeks (Crossover Phase of the Study)|Optical Coherence Tomography (OCT) scans were graded in masked fashion by Duke University Reading Center (Durham, North Carolina). Per the initial protocol specifications, OCT scans were to be performed on a Cirrus OCT machine; however, some scans were performed on a Spectralis OCT machine at one of the sites due to technical difficulties. The protocol was amended to allow for Cirrus and Spectralis OCT scans at subsequent visits at the affected site. Spectralis values were then converted to Cirrus central subfield mean thickness (CSMT) values through a validated linear conversion function.|Baseline and 36 Weeks|A total of 56 participants (62 eyes) were enrolled and 55 participants (61 eyes) completed the 36-week crossover phase of the study.|||micrometers|Participants|95% Confidence Interval|Mean
2656903|NCT01610557|Primary|Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) From Baseline to 36 Weeks (Crossover Phase of the Study)|"The primary outcome for 3-months change in BCVA utilized data from Weeks 12, 24 and 36 aggregated in a linear mixed-effects model. This model included adjustments accounting for period (i.e., Weeks 12, 24 and 36), treatment in current period, treatment in prior period, and baseline BCVA to provide the estimated 3-month BCVA change.~Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20."|Baseline and 36 Weeks|A total of 56 participants (62 eyes) were enrolled and 55 participants (61 eyes) completed the 36-week crossover phase of the study.|||ETDRS letters|Participants|95% Confidence Interval|Mean
2658122|NCT01600287|Other Pre-specified|Total Propofol Used (mg/kg/hr)|total propofol used based on per kg body weight per hour for the whole duration of surgery|8 hours (approx)||||mg per kg body weight per hour||Standard Deviation|Mean
2656904|NCT01610492|Secondary|Urine BLys Levels as a Ratio to Creatinine|B lymphocyte stimulator (BLyS) normalized by creatinine as a ratio of BLyS: creatinine. Free BLyS protein is being analyzed using an ELISA. Urine samples are being collected before treatment and after belimumab washout at Week 0 and Week 116/16 week follow-up visit. Only raw BLyS values available and unable to be assessed due to lack of comparison to a creatinine as a urine concentration marker.|Baseline and Week 116/16 week follow-up visit|ITT Population||||||
2656905|NCT01610492|Secondary|Serum BLys Levels|Free BLyS protein were analyzed using an ELISA. Serum samples were collected before treatment and after belimumab washout at Week 0 and Week 116/16 week follow-up visit.|Baseline and Week 116/16 week follow-up visit|ITT Population|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2656906|NCT01610492|Secondary|Change From Baseline in Cytokines/Chemokine|Cytokine/chemokine associated with T helper skewing or autoimmune pathology will be analyzed using Luminex, ELISA. Serum analyte quantification were used to confirm altered protein levels of any gene expression increases or decreases identified by transcriptomic analysis. Endpoint was moved to 'Exploratory' in Protocol amendment 5 as benefits of assessing cytokines was deemed low. Samples were not analyzed.|Baseline and up to Week 104/4 week post last dose|ITT Population||||||
2656907|NCT01610492|Secondary|Change From Baseline in B Cell and T Cell Markers Concentration|B cell Facs panels were used to measure changes over the course of therapy in B cell subsets such as transitional, naïve, memory and plasma B cell compartments by percent of the B cell compartments and absolute numbers. T cell Facs panel were used to measure changes in T cell subsets, such as T regs and CD4+ and CD8+ T cells, in terms of numbers and expression of activation markers to establish if B cell targeting with belimumab affects the T cell compartment perhaps through limiting B cell antigen presentation or cytokine release. Baseline is defined as Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to Week 128/6 month post last dose|ITT Population|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2656908|NCT01610492|Secondary|Change From Baseline in Urine Membrane Attack Complex (MAC)|Urine membrane attack complex will be assayed quantitatively by ELISA method. Urine MAC samples are being collected at Day 0 and Weeks 8, 28, 52, 76 and 4 week post last dose. Results will be normalized using urine creatinine concentration to adjust for urine dilution, before calculation of the ratio as value at time point divided by value at Baseline (Day 0). Endpoint was changed to 'exploratory' as risk of availability of functioning assay for urine membrane attack complex was noted. No assay was subsequently found and samples were not analyzed.|Baseline and up to 4 week post last dose|ITT Population||||||
2656909|NCT01610492|Secondary|Urine Membrane Attack Complex (MAC) Levels|Urine membrane attack complex was assayed quantitatively by ELISA method. Urine MAC samples were collected at Day 0 and Weeks 8, 28, 52, 76 and 4 week post last dose. Results were normalized using urine creatinine concentration to adjust for urine dilution. Endpoint was moved to 'Exploratory' in Protocol amendment 5 as risk of availability of functioning assay for urine membrane attack complex was noted. No assay was subsequently found and samples were not analyzed|Baseline and up to 4 week post last dose|ITT Population||||||
2656910|NCT01610492|Secondary|Number of Participants With Positive Immunogenicity Findings|Blood samples of participants were collected pre-dose on Weeks 0, 12, 28, 40, 52, 76, 4 week post last dose and 16 week post last dose visit for belimumab immunogenicity assay. No participants showed positive immunogenicity findings.|Baseline and up to Week 116/16 week follow-up visit|ITT Population|||Participants|||Number
2656911|NCT01610492|Secondary|Change From Baseline in Temperature|Temperature was measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 week post last dose visits. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Week 116/16 week follow-up visit|ITT Population|||Celsius||Standard Deviation|Mean
2656912|NCT01610492|Secondary|Change From Baseline in Pulse Rate|Pulse rate was measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 Week post last dose visits. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to Week 116/16 week follow-up visit|ITT Population|||Beats per minute||Standard Deviation|Mean
2656913|NCT01610492|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured from Baseline throughout the treatment period up to Week 116/ 16 week follow-up visit. The Baseline value was taken at Day 0 pre dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean and standard deviation (SD) were measured and presented for Week 12, 28, 52, 76, 104 withdrawn visit, 4 Week post last dose and 16 Week follow-up visit. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to week 116/16 week follow-up visit|ITT Population|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2656914|NCT01610492|Secondary|Number of Participants With Urinalysis Dipstick Findings|Urine samples were collected for urinalysis by dipstick method from Baseline up to Week 116/16 months follow up and number of participants with findings were presented for Baseline, Week 12, 28, 52, 76, 104/4 weeks post last-dose and Week 116/16 week follow up (WF). The urinalysis parameters included occult blood, glucose, ketones, protein. The findings were presented as trace or 1/10 g/100 milliliter (dL), trace, negative, 4+, 3+, 3+ or 1 g/dL, 2+ or 1/2 g/dL, 2+, 1+ or 1/4 g/dL and 1+. Only participants present at the specific time points were presented (represented by n=X in the category titles).|Baseline and up to Week 116/16 Week follow up|ITT Population|||Participants|||Number
2657020|NCT01609933|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as HCV RNA level < LLOQ at Substudy 1 treatment weeks 4 through 12 without a confirmed HCV RNA >= LLOQ|Treatment weeks 4 through 12 of Substudy 1 (DAAs plus pegIFN alpha-2a and RBV)|ITT Population|||percentage of participants||95% Confidence Interval|Number
2656915|NCT01610492|Secondary|Number of Participants With Abnormal Clinical Chemistry and Hematology Values|Blood samples were collected from participants for evaluation of clinical chemistry and hematology parameters. The clinical chemistry parameters included albumin, alkaline phosphatase (alk.phosph.), alanine amino transferase (ALT), aspartate amino transferase (AST), total and direct bilirubin, calcium, cholesterol, chloride, carbon dioxide, creatinine, gamma glutamyl transferase (GGT), glucose, potassium, lactate dehydrogenase (LD), magnesium, sodium, phosphorus, total protein, blood urea nitrogen (BUN) and uric acid. The hematology parameters included basophils, eosinophil, hemoglobin, hematocrit, lymphocytes, monocytes, total neutrophils, platelets, red blood cells (RBC) count and white blood cells (WBC) count. Participants were counted in the category that their value changes to (low or high) for the specific time points. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Baseline and up to Week 116/16 week follow-up visit|ITT Population|||Participants|||Number
2656916|NCT01610492|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The analysis was performed on Safety Population which comprised of all participants who were randomized into the study. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, is a congenital anomaly/birth defect, may require medical or surgical intervention, is associated with liver injury and impaired liver function.|Baseline and up to Week 128/6 month follow up|ITT Population|||Participants|||Number
2656917|NCT01610492|Secondary|Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score|Health-related quality of life was assessed through participant self-completion of the short form health survey (SF-36 version [v2]), a general health related quality of life metrics. Norm-based Scores (NBS) for physical functioning, role emotional, role physical were assessed. The remaining SF-36 component scores require re-scaling and therefore will be added at a later date. SF-36 was administered prior to any procedures at Weeks 12, 28, 52, 76 and 104/4 week post last dose. Item score were recorded and higher score represented better health status. Baseline is defined as Day 0 pre dose value and change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|Baseline and up to Week 104/4 week post last dose|ITT Population|||Scores on a scale||Standard Deviation|Mean
2656918|NCT01610492|Secondary|Summary of Total Amount of Urine Excreted Ae(0-24)|PK parameters from the urine concentration data: urine Ae(0-24) were assessed. 24 h urine collections for PK analysis were collected after the Day 0 and Weeks 12, 28, 52, 76 doses and at the 4 week post last dose visit. A population approach was undertaken to characterize the population PK parameters and associated variability of belimumab in nephrotic participants. The population approach could have provided derived clearance of belimumab for each participant after the first dose. The population PK analysis was conducted using nonlinear mixed-effect modeling (NONMEM) or appropriate nonlinear mixed-effect analysis software. Several samples were taken pre-dose at Day 0 and some at week 12 incorrectly which affects interpretation.|Baseline and Up to 4 week post last dose|PK Population|||ng/hour||Standard Deviation|Mean
2656919|NCT01610492|Secondary|Summary of Area Under the Serum Concentration-time Curve to the Last Quantifiable Concentration (AUC[0-2])|The AUC(0-2) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples for PK analysis were collected at the following time points: pre-dose (on dosing days): Days 0, 1, 4, 7, 14 and Week 4, 8, 12, 28, 40, 52, 76 and 4 week post last dose. Post-dose (5 minutes after dosing complete): Days 0 and 28. The results will be posted at later date following post hoc analysis.|Baseline and up to 4 week post last dose|PK Population||||||
2656920|NCT01610492|Secondary|Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points|Trough concentration (Cmin) samples collected on the specified days are being used to assess attainment whether there was sufficient belimumab despite it being lost in the urine from the proteinuria and to check if it improved as proteinuria resolved. Analysis was performed on pre-infusion samples at weeks 2,4,8,12,28,40,52,76 and the 4 week post last-dose.|Baseline and up to 4 week post last dose|PK Population|||ng/mL||Standard Deviation|Mean
2656921|NCT01610492|Secondary|Summary of Maximum Observed Serum Concentration (Cmax) of Belimumab at the Indicated Time Points|The first occurrence of Cmax was determined directly from the serum concentration-time data. The pharmacokinetic (PK) parameters were calculated by standard non-compartmental analysis and all calculations of non-compartmental parameters are being based on actual sampling times.|Baseline and up to 4 week post last dose|PK Population: all participants in the ITT Population for whom a PK sample was obtained and analyzed.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2656922|NCT01610492|Secondary|Number of Participants With Edema and Edema Extending Beyond Calf|Reduction of proteinuria lessens the risk of thromboembolic and cardiovascular effects and reduces the edema in participants. Investigators physically reviewed participants for clinical manifestations of idiopathic membranous glomerulonephropathy (IMGN) (e.g. edema extending beyond calf) during study and analysis was performed at Week 12, 28, 52, 76 Week 104. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|Baseline and Weeks 12, 28, 52, 76, and 104|ITT Population|||Participants|||Number
2656923|NCT01610492|Secondary|Change From Baseline in Serum IgG at the Indicated Time Points|Serum IgG was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum IgG is defined as the pre-dose Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow up|ITT Population|||Ratio||Standard Deviation|Mean
2656924|NCT01610492|Secondary|Serum Immunoglobulin G (IgG) Levels at Indicated Time Points|Serum IgG was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum IgG is defined as the pre-dose Day 0 value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population|||g/L||Standard Deviation|Mean
2656925|NCT01610492|Secondary|Change From Baseline in Serum Cholesterol at the Indicated Time Points|Serum cholesterol was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum cholesterol is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population|||mmol/L||Geometric Coefficient of Variation|Geometric Mean
2656926|NCT01610492|Secondary|Serum Cholesterol Levels at Indicated Time Points|Serum cholesterol was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum cholesterol is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population|||millimoles per liter (mmol/L)||Geometric Coefficient of Variation|Geometric Mean
2656927|NCT01610492|Secondary|Change From Baseline in Levels of Serum Albumin at the Indicated Time Points|Serum albumin was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population|||ratio||Geometric Coefficient of Variation|Geometric Mean
2656928|NCT01610492|Secondary|Serum Albumin Levels at Indicated Time Points|Serum albumin was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum albumin is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up.|ITT Population|||grams per liter (g/L)||Geometric Coefficient of Variation|Geometric Mean
2656929|NCT01610492|Secondary|Change From Baseline in Serum Creatinine Levels at the Indicated Time Points|Serum creatinine was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2656930|NCT01610492|Secondary|Serum Creatinine Levels at the Indicated Time Points|Serum creatinine was assessed as a clinical chemistry laboratory parameter from Baseline up to Week 128/6 month follow-up visit. Baseline for serum creatinine is defined as the mean of the Screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population|||micromoles/liter (µmol/L)||Geometric Coefficient of Variation|Geometric Mean
2656931|NCT01610492|Secondary|Change From Baseline in eGFR Levels at the Indicated Time Points|eGFR was assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by national kidney foundation-chronic kidney disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the Screening and Day 0 values and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to Week 128/6 month follow up|ITT Population|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2656932|NCT01610492|Secondary|eGFR Levels at the Indicated Time Points|eGFR was assessed from levels of creatinine using the 4 variable version of the modification of diet in renal disease (MDRD) equation as recommended by National Kidney Foundation-Chronic Kidney Disease (NKF-CKD) guidelines. Baseline for eGFR is defined as the mean of the screening and Day 0 values. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up.|ITT Population|||milliliter/minute (mL/min/1.73meter^2)||Geometric Coefficient of Variation|Geometric Mean
2656933|NCT01610492|Secondary|Number of Participants With Anti-PLA2R Autoantibody Relapse|Incidence of anti-PLA2R autoantibody relapse defined as antibody detectable after previously undetectable. Anti-PLA2R autoantibody blood samples were evaluated at Week 12, 28, 52, 76, 104/4 week post last dose, Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|Baseline and up to Week 128/6 month follow up|ITT Population|||Participants|||Number
2656934|NCT01610492|Secondary|Time to Anti-PLA2R Autoantibody Remission|Time to anti-PLA2R autoantibody remission was estimated using Kaplan-Meier method for full response and partial response full response with antibody undetectable and partial response with reduction in titers by 50 percent.|Baseline and up to Week 128/6 month follow up|ITT Population|||Weeks||95% Confidence Interval|Median
2656935|NCT01610492|Secondary|Number of Participants With PLA2R Autoantibody Remission|Incidence of anti-PLA2R autoantibody remission were evaluated by full response and partial response. Full response is defined as antibody undetectable, partial response is defined as reduction in titers by 50 percent. For anti PLA2R autoantibody data, log transformation was applied before the formal analyses. Anti-PLA2R autoantibody blood samples were evaluated at Week 12, 28, 52, 76, 104 and 128/6 week post last-dose. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128|ITT Population|||Participants|||Number
2656936|NCT01610492|Secondary|Duration of Complete or Partial Remission|Complete remission is defined as PCR <30 mg/mmol (proteinuria <0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline <15percent). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50% from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline <15percent). Only those participants available at the specified time points were analyzed (represented by n=X in category titles). NA indicates that data was not available as only 1 participant reached complete remission. Hence, standard deviation for complete remission was not calculated.|Baseline and up to Week 128/6 month follow up|ITT Population|||Days||Standard Deviation|Mean
2656937|NCT01610492|Secondary|Time to Complete or Partial Remission|Time to complete or partial remission was estimated using the Kaplan-Meier method. Complete remission is defined as PCR <30 mg/mmol (proteinuria <0.3g/24 h) with no worsening in renal function (eGFR reduction from Baseline <15 percent ). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50 percent from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline <15 percent). Only 1 participant reached complete remission. Hence, statistical analysis for complete remission was not performed.|Baseline and up to Week 128/6 month follow up|ITT Population|||Weeks||95% Confidence Interval|Median
2656938|NCT01610492|Secondary|Number of Participants With Complete or Partial Remission|Complete remission is defined as PCR <30 mg/mmol (proteinuria <0.3grams [g]/24 h) with no worsening in renal function (estimated glomerular filtration rate [eGFR] reduction from Baseline <15 percent). Partial remission is defined as PCR <350 mg/mmol (proteinuria <3.5 g/24 h) but >= 30 mg/mmol (proteinuria >= 0.3g/24h) and decrease of >50 percent from Day 0 Baseline, together with no consistent worsening in renal function (eGFR reduction from Baseline <15percent). Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128|ITT Population|||Participants|||Number
2656939|NCT01610492|Secondary|Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time Points|Anti-PLA2R autoantibody titers in serum were analyzed by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from Euroimmun. Baseline is defined as the Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 12, 28, 52, 76, 104 and 128.|ITT Population|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2656940|NCT01610492|Secondary|Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points|Anti-PLA2R autoantibody titers in serum were analyzed by means of a validated anti-PLA2R enzyme linked immunosorbent assay (ELISA) assay from Euroimmun. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population.|||relative units per milliliter (RU/mL)||Geometric Coefficient of Variation|Geometric Mean
2656941|NCT01610492|Secondary|Change From Baseline in Proteinuria Levels at the Indicated Time Points|Proteinuria based on urinary protein creatinine ratio (PCR) measured from 2 consecutive 24h urine collections at Baseline and Week 28, from a pre-intervention spot urine sample and 24 hour urine collection after visit at Weeks 12, 52, 76 and 104, and from a spot urine sample at week 128. Mean PCR was calculated at each time point where there were 2 samples. Baseline is defined as Day 0 value and change from Baseline was calculated as ratio of post-Baseline value divided by the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Week 12, 28, 52, 76, 104 and Week 128/6 month follow up|ITT Population.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2656942|NCT01610492|Secondary|Proteinuria Levels at the Indicated Time Points|Proteinuria based on urinary protein creatinine ratio (PCR) measured from 2 consecutive 24h urine collections at Baseline and Week 28, from a pre-intervention spot urine sample and 24 hour urine collection after visit at Weeks 12, 52, 76 and 104, and from a spot urine sample at week 128. Mean PCR was calculated at each time point where there were 2 samples. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up|ITT Population|||milligrams per millimole (mg/mmol)||Geometric Coefficient of Variation|Geometric Mean
2656943|NCT01610492|Primary|Change From Baseline in Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Titers at Week 28|PLA2R autoantibody titers in serum were analyzed at Baseline and Week 28 by means of a validated anti- PLA2R enzyme linked immunosorbent assay (ELISA) from EuroImmun. Baseline is defined as the Day 0 value and change from Baseline was calculated as ratio to Baseline by dividing the Week 28 values with the Baseline values. Ratio to Baseline: Estimated value = 0.27, 2-sided 95% CI=0.12 to 0.58. The geometric mean method was used to calculate the CI.|Baseline and Week 28|ITT Population. Only those participants available at the indicated time point (Week 28) were analyzed.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2656944|NCT01610492|Primary|Change From Baseline in Proteinuria Levels at Week 28|Proteinuria based on urinary protein creatinine ratio (PCR) was measured from 2 consecutive 24 hour (h) urine collection pre and post dosing at Baseline and Week 28 and the mean PCR was determined at each time point. Baseline is defined as the mean of the pre and post dosing Day 0 values. The ratio is defined as the Week 28 value divided by the Baseline value. Ratio to Baseline: Estimated value = 0.76, 2-sided 95% confidence interval (CI)=0.57 to 1.01. The geometric mean method was used to calculate the CI. The analysis was performed on Intent-to-treat (ITT) Population which comprised of all eligible participants who received at least one dose of investigational drug. Only those participants available at the indicated time point (Week 28) were analyzed.|Baseline and Week 28|Intent-to-Treat (ITT) Population|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2656945|NCT01610453|Secondary|Percentage of Women With Cesarean Section|The percentage of women with cesarean section was compared in cases with occiput posterior position and cases with non occiput posterior position assessed with transabdominal sonography when prolonged labor was diagnosed.|active labor|Fetal head position was assessed successfully using transabdominal ultrasound in 142/150 women. Position could not be diagnosed in eight cases due to shadowing from maternal pelvis in cases at low stations.|||percentage of participants in each group|||Number
2656946|NCT01610453|Primary|Percentage of Women With Vaginal Deliveries|Women were categorized in accordance to fetal descent measured by ultrasound. Head-perineum distance (HPD) ≤40 mm and angle of progression (AoP) ≥110 degrees were used as cut-off level. HPD was obtained in all 150 cases and AoP was successfully obtained in 145 cases.|active labor|AoP could not be measured in 5 cases because only a part of the symphysis was visualized.|||percentage of participants in each group||95% Confidence Interval|Number
2656947|NCT01610427|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitali-zation or prolongation of hospitalization or result in disability/incapacity.|During the whole study period (From Day 0 to Day 15)|The analysis was performed on the Total eligible cohort which included all subjects in the Total cohort (all enrolled subjects) who fulfilled eligibility criteria.|||Participants|||Count of Participants
2656948|NCT01610427|Secondary|Magnitude of HIV-RT Specific (Background Reduced) CD8+ T Cell Responses in the CMI Samples Post-overnight ICS/Post 6 Hour ICS, Expressing at Least One Cytokine|HIV-RT specific responses of CD8+ T cells expressing at least one cytokine, among: Interleukin-2 (IL-2), Interferon-gamma (IFN-g) and Tumor necrosis factor alpha (TNF-a),after stimulation with HIV-1 peptide pools for time-to-process (TP) (2, 7, 24 hours) and resting time (RT) (0,2,6,18 hours) post-overnight ICS and for time-to-process (7 hours) and resting time (18 hours) post 6 hours ICS.|At Day 15 (sample collection visit)|The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.|||Percentage of CD8+ T cells||Inter-Quartile Range|Median
2656949|NCT01610427|Secondary|Magnitude of HIV-1 RT Specific Cluster of Differentiation 40 Ligand (CD40L+) CD4+ T Cell Responses in the CMI Samples Post-overnight ICS/Post 6 Hour ICS, Expressing at Least One Cytokine|Data were collected but could not be reported as data were below level of detection.|At Day 15 (sample collection visit)|The analysis was to be performed on the According to Protocol (ATP) Sample Collection cohort. Data were collected but could not be reported as data were below the detection level.||||||
2656950|NCT01610427|Secondary|Percentage of Viable Lymphocytes in the CMI Samples, Post-overnight Incubation (Classic) Before ICS and Post-6 Hour Incubation Before ICS|The percentage of viable lymphocytes was determined by Forward Scatter/Side Scatter (FSC/SSC) and LIVE/DEAD gating during flow cytometry analysis for each incubation of time-to-time process (TP) = 2h, 7h and 24 h and resting time (RT) = 18h for the comparison of resting time = 18h and classic incubation time versus resting time = 18h and post-6h incubation time.|A Day 15 (sample collection visit)|The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.|||Percentage of viable lymphocytes||95% Confidence Interval|Mean
2656951|NCT01610427|Primary|"Lymphocytes Viability Prediction (Non-transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: Optimum Mean Cell Viability Estimates by the Prediction Model -Condition None Resting Time Included."|"The objective was to model lymphocyte viability according to time-to-process (TP=2h, 7h or 24h) and resting time (RT=0h) conditions in order to select the best combination of these two parameters with the aim to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 ^ P / (1 + 10 ^ P) * 100 with P for Prediction. The optimum of the viability was predicted as follows. P (LOGIT)= intercept + a*TP + b*RT + a*b*TP*RT + + b*b*RT*RT. Where intercept, TP, RT, TP*RT, TP *TP, RT*RT are the parameters evaluated and presented in the primary outcomes 5, 6 and 7. And a and b are parameters (hour) corresponding respectively to the TP and the RT where the prediction has to be done. The optimum predicted mean cell viability of this Design of Experiment is presented in this outcome and expressed as percentage."|At Day 15 (sample collection visit)|The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.|||Percentage of viable lymphocytes|||Number
2656952|NCT01610427|Primary|"Lymphocytes Viability Prediction (Non-transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: TP*RT and RT*RT Parameter Estimates of the Prediction Model - Condition None Resting Time Included"|"The objective was to model lymphocyte viability according to time-to-process (TP=2h, 7h or 24h) and resting time (RT=0h) conditions in order to select the best combination of these two parameters with the aim to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 ^ P / (1 + 10 ^ P) * 100 with P for Prediction. The optimum of the viability was predicted as follows. P (LOGIT)= intercept + a*TP + b*RT + a*b*TP*RT + + b*b*RT*RT. Where intercept, TP, RT, TP*RT, TP *TP, RT*RT are the parameters evaluated and presented in the primary outcomes 5, 6 and 7. And a and b are parameters (hour) corresponding respectively to the TP and the RT where the prediction has to be done. This outcome is presenting TP*RT and RT*RT estimates expressed as log(hours^2). The optimum of this DOE is presented in outcome 8."|At Day 15 (sample collection visit)|The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.|||Log(hours^2)||Standard Error|Log Mean
2656953|NCT01610427|Primary|"Lymphocytes Viability Prediction (Non-transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: Time to Process and Resting Time Parameter Estimates of the Prediction Model - Condition None Resting Time Included"|"The objective was to model lymphocyte viability according to time-to-process (TP=2h, 7h or 24h) and resting time (RT=0h) conditions in order to select the best combination of these two parameters with the aim to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 ^ P / (1 + 10 ^ P) * 100 with P for Prediction. The optimum of the viability was predicted as follows. P (LOGIT)= intercept + a*TP + b*RT + a*b*TP*RT + + b*b*RT*RT. Where intercept, TP, RT, TP*RT, TP *TP, RT*RT are the parameters evaluated and presented in the primary outcomes 5, 6 and 7. And a and b are parameters (hour) corresponding respectively to the TP and the RT where the prediction has to be done. This outcome is presenting TP and RT estimates expressed as log(hours). The optimum of this Design of Experiment (DOE) is presented in outcome 8."|At Day 15 (sample collection visit)|The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.|||Log(hours)||Standard Error|Log Mean
2656954|NCT01610427|Primary|"Lymphocytes Viability Prediction (Non-transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: Intercept Parameter Estimate of the Prediction Model - Condition None Resting Time Included"|"The objective was to model lymphocyte viability according to time-to-process (TP=2h, 7h or 24h) and resting time (RT=0h) conditions in order to select the best combination of these two parameters with the aim to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 ^ P / (1 + 10 ^ P) * 100 with P for Prediction. The optimum of the viability was predicted as follows. P (LOGIT)= intercept + a*TP + b*RT + a*b*TP*RT + + b*b*RT*RT. Where intercept, TP, RT, TP*RT, TP *TP, RT*RT are the parameters evaluated and presented in the primary outcomes 5, 6 and 7. And a and b are parameters (hour) corresponding respectively to the TP and the RT where the prediction has to be done. This outcome is presenting the intercept i.e. expected mean value of Prediction when TP and RT = 0. The optimum of this Design of Experiment is presented in outcome 8."|At Day 15 (sample collection visit)|The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.|||Unitless assessment of prediction||Standard Error|Log Mean
2656955|NCT01610427|Primary|"Lymphocytes Viability Prediction (LOGIT Transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: Optimum Mean Cell Viability Estimate by the Prediction Model - Condition None Resting Time Not Included"|"The objective was to model lymphocyte viability according to time-to-process (TP=2h, 7h or 24h) and resting time (RT=2h, 6h or 18h [none resting time not included]) conditions to select the best combination of these two parameters to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 ^ P / (1 + 10 ^ P) * 100 with P for Prediction.The optimum of the viability was predicted as P (LOGIT)= intercept + a*TP + b*RT + a*b*TP*RT + a*a*TP*TP + b*b*RT*RT. Where intercept, TP, RT, TP*RT, TP *TP, RT*RT are the parameters evaluated and presented in the 3 first primary outcomes. And a and b are log-transformed parameters corresponding respectively to the TP and the RT where the prediction has to be done. The optimum predicted mean cell viability of this Design of Experiment is presented in this outcome and expressed as percentage."|At Day 15 (sample collection visit)|The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.|||Percentage of viable lymphocytes|||Number
2656956|NCT01610427|Primary|"Lymphocytes Viability Prediction (LOGIT Transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: TP*RT, TP*TP and RT*RT Parameter Estimates of the Prediction Model - Condition None Resting Time Not Included"|"The objective was to model lymphocyte viability according to time-to-process (TP=2h, 7h or 24h) and resting time (RT=2h, 6h or 18h [none resting time not included]) conditions to select the best combination of these two parameters to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 ^ P / (1 + 10 ^ P) * 100 with P for Prediction.The optimum of the viability was predicted as P (LOGIT)= intercept + a*TP + b*RT + a*b*TP*RT + a*a*TP*TP + b*b*RT*RT. Where intercept, TP, RT, TP*RT, TP *TP, RT*RT are the parameters evaluated and presented in the 3 first primary outcomes. And a and b are log-transformed parameters corresponding respectively to the TP and the RT where the prediction has to be done. This outcome is presenting TP*RT, TP*TP and RT*RT estimates expressed as log(hours^2). The optimum of this DOE is presented in outcome 4."|At Day 15 (sample collection visit)|The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.|||Log(hours^2)||Standard Error|Log Mean
2656957|NCT01610427|Primary|"Lymphocytes Viability Prediction (LOGIT Transformed Estimate) in CMI Samples Post-overnight Incubation Time Before ICS: Time to Process and Resting Time Parameter Estimates of the Prediction Model - Condition None Resting Time Not Included"|"The objective was to model lymphocyte viability according to time-to-process (TP=2h, 7h or 24h) and resting time (RT=2h, 6h or 18h [none resting time not included]) conditions to select the best combination of these two parameters to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10 ^ P / (1 + 10 ^ P) * 100 with P for Prediction.The optimum of the viability was predicted as P (LOGIT)= intercept + a*TP + b*RT + a*b*TP*RT + a*a*TP*TP + b*b*RT*RT. Where intercept, TP, RT, TP*RT, TP *TP, RT*RT are the parameters evaluated and presented in the 3 first primary outcomes. And a and b are log-transformed parameters corresponding respectively to the TP and the RT where the prediction has to be done. This outcome is presenting TP and RT estimates expressed as log(hours). The optimum of this Design of Experiment (DOE) is presented in outcome 4."|At Day 15 (sample collection visit)|The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.|||Log(hours)||Standard Error|Log Mean
2656958|NCT01610427|Primary|"Lymphocytes Viability Prediction (LOGIT Transformed) in CMI Samples Post-overnight Incubation Time Before Intracellular Cytokine Staining (ICS): Intercept Parameter Estimate of the Prediction Model - Condition None Resting Time Not Included"|"The objective was to model lymphocyte viability according to time-to-process (TP=2h, 7h or 24h) and resting time (RT=2h, 6h or 18h [none resting time not included]) conditions to select the best combination of these two parameters to maximize the post-ICS viability in CMI samples collected from ART-naïve HIV-1-infected subjects. Viability (%) = 10^P/(1 + 10^P)*100 with P for Prediction.The optimum of the viability was predicted as P (LOGIT)= intercept + a*TP + b*RT + a*b*TP*RT + a*a*TP*TP + b*b*RT*RT. Where intercept, TP, RT, TP*RT, TP *TP, RT*RT are the parameters evaluated and presented in the 3 first primary outcomes. And a and b are log-transformed parameters corresponding respectively to the TP and the RT where the prediction has to be done. This outcome is presenting the intercept i.e. expected mean value of Prediction when TP and RT = 0. The optimum of this Design of Experiment is presented in outcome 4."|At Day 15 (sample collection visit)|The analysis was performed on the According to Protocol (ATP) Sample Collection cohort, which included all subjects accepted into the analysis.|||Unitless assessment of prediction||Standard Error|Log Mean
2656959|NCT01610414|Secondary|Number of Subjects With Fatal SAEs and SAEs Related to Study Participation or to a GSK Concomitant Medication or Vaccination|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. This endpoint presents fatal SAEs and SAEs related to study participation or to a concurrent GSK medication/vaccine.|From the Pre-vaccination visit (Up to 110 days prior Month 0) until study end (approximate median of 29 months follow-up minimum 1 year and maximum 4 years)|The analysis was performed on the Total Enrolled Cohort.|||Participants|||Count of Participants
2656960|NCT01610414|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs to GSK Study Vaccine/Placebo|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. This enpoint also presents SAES related to the GSK study vaccine/placebo.|From Month 0 until 365 days post last vaccination (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered.|||Participants|||Count of Participants
2656961|NCT01610414|Secondary|Number of Subjects With Any Relapse|Relapse was defined as the occurrence of the underlying malignancy or disease for which the HCT was undertaken.|From Month 0 until study end (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years)|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered.|||Participants|||Count of Participants
2656962|NCT01610414|Secondary|Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)|Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From Month 0 up to 365 days post last vaccination|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered.|||Participants|||Count of Participants
2656963|NCT01610414|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (Days 0-29) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered.|||Participants|||Count of Participants
2656964|NCT01610414|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary/tympanic temperature equal to or above 37.5 degrees Celsius (°C) or rectal temperature equal to or above 38.0 °C]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered, who had filled in their symptom sheets.|||Participants|||Count of Participants
2656965|NCT01610414|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with respect to the vaccine actually administered, who had filled in their symptom sheets.|||Participants|||Count of Participants
2656966|NCT01610414|Secondary|Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects|Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seropositivity cut-off value was greater than or equal to (≥) 97 mIU/mL.|At Months 0, 1, 2, 13 and 25|The analysis was performed on the adapted According-to-Protocol (ATP) cohort for humoral immunogenicity, which included data from the ATP cohorts for humoral immunogenicity at Months 0,1,2,13 and 25. The ATP cohort for humoral immunogenicity included all subjects from humoral immunogenicity sub-cohort in ATP cohort for analysis of immunogenicity.|||mIU/mL||95% Confidence Interval|Geometric Mean
2656967|NCT01610414|Secondary|Number of Subjects With Postherpetic Neuralgia (PHN)|This analysis excluded PHN episodes that were linked to a confirmed HZ case that occurred after the start of the relapse treatment.|From Month 0 until study end (21 months median follow-up)|The analysis was performed on the modified Total Vaccinated Cohort, which excluded subjects from the Total Vaccinated Cohort analysis who were not administered with the second vaccination or who received vaccine doses/or replacement not on the same group or who developed a confirmed case of HZ prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2656968|NCT01610414|Secondary|Number of Subjects With Confirmed HZ-associated Complications|This analysis excluded complications that were linked to a confirmed HZ case that occurred after the start of the relapse treatment.|From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)|The analysis was performed on the modified Total Vaccinated Cohort, which excluded subjects from the Total Vaccinated Cohort analysis who were not administered with the second vaccination or who received vaccine doses/or replacement not on the same group or who developed a confirmed case of HZ prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2656969|NCT01610414|Secondary|Duration of 'Worst' HZ-associated Pain|Duration of HZ-associated pain rated as 3 or greater on the 'worst pain' Zoster Brief Pain Inventory (ZBPI) question, following the onset of a confirmed HZ rash over the entire pain reporting period in subjects with confirmed HZ; presented as T (day) [=the sum of follow-up period (for subjects without severe worst pain T is 1, for subjects with severe worst pain T is the duration of severe worst pain) expressed in days].|From Month 0 until study end (4 years approximately), from the onset of a confirmed HZ rash over the entire pain reporting period|The analysis was performed on the modified Total Vaccinated Cohort, which excluded subjects from the Total Vaccinated Cohort analysis, who developed a confirmed case of HZ prior to 1 month after the second vaccination.|||T (day)|||Number
2656970|NCT01610414|Primary|Number of Subjects With Confirmed Herpes Zoster (HZ) Episode|"A suspected case of HZ was defined as (1) a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations), or a vesicular rash suggestive of VZV infection regardless of the distribution, and no alternative diagnosis; or (2) a clinical presentation (symptoms and/or signs) and specific laboratory findings* suggestive of VZV infection in the absence of characteristic HZ or VZV rash.~A suspected case of HZ was confirmed either: by Polymerase Chain Reaction (PCR) or by the HZ Ascertainment Committee (HZAC), consisting of physicians with HZ expertise."|From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)|The analysis was performed on the modified Total Vaccinated Cohort, which excluded subjects from the Total Vaccinated Cohort analysis who were not administered with the second vaccination or who received vaccine doses/or replacement not on the same group or who developed a confirmed case of HZ prior to 1 month after the second vaccination.|||Participants|||Count of Participants
2657159|NCT01608308|Secondary|Number of Participants Who Experienced Postoperative Morbidity (Nausea)|Post-operative nausea will be monitored and measured through direct observation and nursing clinical record|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)||||participants|||Number
2656971|NCT01610297|Secondary|Change in the Further Parameters of Iron Overload (Cardiac Iron Concentration by Magnetic Resonance Imaging (MRI Examination)|Cardiac MRI values between 10 to 20 milliseconds (ms) are indicative of moderate cardiac iron deposition associated with declining left ventricular ejection fraction and arrhythmias while values <10 ms are indicative of deposition sufficient to risk cardiac decompensation and associated with overt heart failure and mortality.|Baseline, 12 month|The Full Analysis Set (FAS) comprises all patients in whom study treatment has been started and received at least one dose.|||ms||Standard Deviation|Mean
2656972|NCT01610297|Secondary|The Percentage of Patients Reaching Serum Ferritin Levels Lower Than 500 μg/L|Serum Ferritin values between 1000-2500 μg/L are indicative of mild to moderate iron overload while values >2500 μg/L are indicative of severe iron overload and levels constantly higher than 2500 μg/L has been shown to to increase the risk of cardiac complications and endocrine disease. Maintaining levels <1000 μg/L is associated with increased survival and less morbidity.|Week 28 and Week 52|The Full Analysis Set (FAS) comprises all patients in whom study treatment has been started and received at least one dose.|||Percentage of Patients|||Number
2656973|NCT01610297|Secondary|Change in the Further Parameters of Iron Overload (Liver Iron Concentration by Magnetic Resonance Imaging (MRI Examination)|Liver Iron Concentration (LIC) values between 3 and 7 mg Fe / g dry weight are indicative of mild iron deposition, while values between 7 and 15 mg Fe / g dry weight are indicative of moderate iron deposition which have been associated with liver disease. Values >15 mg Fe/g dry weight are indicative of severe iron deposition which is associated with progressive liver fibrosis, increased morbidity and mortality|Baseline, 12 month|The Full Analysis Set (FAS) comprises all patients in whom study treatment has been started and received at least one dose.|||mg Fe/g dry liver weight||Standard Deviation|Mean
2656974|NCT01610297|Secondary|Change in Serum Ferritin Level.|Blood samples were collected and serum levels were assessed at study baseline (BL) and at 12 months.|Baseline, 12 Months|The Full Analysis Set (FAS) comprises all patients in whom study treatment has been started and received at least one dose.|||ng/mL||Standard Deviation|Mean
2656975|NCT01610297|Primary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths as a Measure of Safety and Tolerability|To determine the safety; incidence, type and severity of adverse events including renal, hepatic, biochemistry and hematologic parameters of deferasirox in the treatment of iron overload after hematopoietic stem cell transplantation (HSCT) in patients with beta-thalassemia major in 12 months period|12 months|The Safety Set (SS) includes all included patients who were included in the study. All statistical analyses of safety and tolerability will be done in the SS.|||Participants|||Number
2656976|NCT01610271|Primary|Percent of Patients With Incisional Surgical Site Infection|"Patient will be clinically evaluated to identify potential incisional SSI through daily visits during the hospital stay, at subsequent clinic visits and hospital stays, or telephonically on a monthly basis for one year. If encounter indicates the potential presence of SSI, physician will make diagnosis of SSI using the CDC criteria. Superficial and deep incisional infections were defined and reported as incisional infections."|Within One Year of Surgical Procedure||||percentage of participants||95% Confidence Interval|Number
2656977|NCT01610271|Primary|Percent of Patients With Implant Surgical Site Infection|"Patient will be clinically evaluated to identify potential implant SSI through daily visits during the hospital stay, at subsequent clinic visits and hospital stays, or telephonically on a monthly basis for one year. If encounter indicates the potential presence of SSI, physician will make diagnosis of SSI using the CDC criteria. Organ/space/implant level infections were defined and reported as implant infections."|Within One Year of Surgical Procedure||||percentage of participants||95% Confidence Interval|Number
2656978|NCT01610271|Primary|Comparison of Levels of Airborne CFU Measured at Incision Sites Between the Control and Air Barrier System Groups|Airborne CFU samplers will be used to monitor bacterial populations at the location immediately adjacent to the surgical site. Air will be drawn through a length of PVC tubing onto agar plates at ten minute intervals. Plates will be incubated for 36 hours at 35 degrees Celsius. Staining and morphological identification will be used to identify and count viable bacteria.|One year post surgery||||CFU/m^3||Standard Deviation|Mean
2656979|NCT01610271|Primary|Incidence of Implant Infection (Number of Occurrences in Each Arm).|"Fewer patients in the Air Barrier System group will have implant infection compared to the Control group. Diagnosis of SSI was made by a physician who was masked to the patients' group assignment and not involved in the patients' care by evaluating medical records using the standard and extremely widely used (clinically, epidemiologically, and in research) CDC criteria*, which categorize SSI into superficial incisional, deep incisional, and organ/space/implant levels. Superficial and deep incisional infections were defined and reported as incisional infections, whereas organ/space/implant level infections were defined and reported as implant infections.~*See Mangram AJ, et al. Guideline for prevention of surgical site infection, 1999: Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol 1999;20:250-278."|One year after surgery||||Participants|||Count of Participants
2656980|NCT01610167|Secondary|Extended Sensitivity Relief. Air Blast Sensitivity.|Assessment of cold air sensitivity. Cold air sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth.|28 days (+/- 2 days) post treatment.||||units on a scale||Standard Deviation|Mean
2656981|NCT01610167|Primary|Immediate Sensitivity Relief. Air Blast Sensitivity.|Sensitivity measurements performed using a cold air blast and sensitivity scored on the four (4) point Schiff scale with 0 equal to no discomfort or awareness of sensitivity and 3 equal to severe pain from sensitive teeth. Score is reported as the change from baseline after treatment.|Immediately after treatment.||||units on a scale||Standard Deviation|Mean
2656982|NCT01610167|Secondary|Extended Sensitivity Relief. Tactile Sensitivity.|"Assessment of sensitivity score via tactile stimulation 28 days post treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with yes response as pressure is increased in 10 gram increments. Measured sensitivity is reported as difference from baseline examination."|28 days (+/- 2 days) post treatment.|Intent to treat (ITT).|||grams||Standard Deviation|Mean
2656983|NCT01610167|Primary|Adverse Events.|Assessment of adverse events that may occur as a result of treatment (typically includes any kind of allergic reation to paste).|Immediately after treatment to 28 days (+/- 2 days) post treatment.|Intent to treat (ITT).|||Number of adverse events.|||Number
2656984|NCT01610167|Primary|Immediate Sensitivity Relief. Tactile Sensitivity.|"Assessment of sensitivity via tactile stimulation immediately after treatment. Tactile sensitivity measured using a Yeaple probe recording tactile pressure in grams before nerve stimulation. Point of nerve stimulation identified by patient with a yes response as pressure is increased in 10 gram increments. Tactile sensitivity is reported as the change from baseline after treatment."|Immediately after treatment.|Intention to treat (ITT).|||grams||Standard Deviation|Mean
2656985|NCT01610154|Secondary|Change From Baseline in Pancreatic α Cell Function in Patients With Different BMI|The glucagon-AUC was adopted to show pancreatic α cell function.|Baseline to 12 weeks||||min∙pg/ml||Standard Deviation|Mean
2656986|NCT01610154|Secondary|Change From Baseline in Pancreatic α Cell Function|The glucagon-AUC was adopted to show pancreatic α cell function.|Baseline to 12 weeks||||min∙pg/ml||Standard Deviation|Mean
2656987|NCT01610154|Secondary|Change From Baseline in Pancreatic β Cell Function in Patients With Different BMI|The early phase insulin response (△I30/△G30) was adopted to determine β cell function.|Baseline to 12 weeks||||μu/ml/mmol||Inter-Quartile Range|Median
2656988|NCT01610154|Secondary|Change From Baseline in Pancreatic β Cell Function|The early phase insulin response (△I30/△G30) was adopted to determine β cell function.|Baseline to 12 weeks||||μu/ml/mmol||Inter-Quartile Range|Median
2656989|NCT01610154|Secondary|Change From Baseline in Insulin Sensitivity in Patients With Different BMI|The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.|Baseline to 12 weeks||||mg/kg/min||Inter-Quartile Range|Median
2656990|NCT01610154|Secondary|Change From Baseline in Insulin Sensitivity|The insulin sensitivity was detected by evaluating the glucose infusion rate (GIR) with euglycemic hyperinsulinemic clamp test.|Baseline to 12 weeks||||mg/kg/min||Inter-Quartile Range|Median
2656991|NCT01610154|Secondary|Change From Baseline in Postprandial Plasma Glucose (PPG)||Baseline to 12 weeks||||mmol/L||Standard Deviation|Mean
2656992|NCT01610154|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)||Baseline to 12 weeks||||mmol/L||Standard Deviation|Mean
2656993|NCT01610154|Primary|Change From Baseline in Hemoglobin A1c (HbA1c)||Baseline to 12 weeks||||percentage||Standard Deviation|Mean
2656994|NCT01610076|Secondary|Willingness to Recommend Video to Other Patients|"Participants were surveyed, Would you recommend this video to other patients? Three options were provided:~Definitely recommend Probably recommend Do not recommend"|immediately after intervention||||participants|||Number
2656995|NCT01610076|Secondary|Perception of Utility of Video|"Participants were surveyed, How helpful was this video in helping you understand your options? There possible answers were provided:~Very helpful Somewhat helpful Not helpful"|immediately after intervention||||participants|||Number
2656996|NCT01610076|Secondary|Participant Reported Comfort With Video Intervention|"Patient's were surveyed about How comfortable were you watching the video?"|immediately after intervention|Patient's surveyed about|||participants|||Number
2656997|NCT01610076|Primary|12 Question Resuscitation Status Survey (Question 4 Has 4 Sub-questions)|"12 question (question 4 has 4 sub-questions) survey previously validated to determine knowledge level about resuscitation status with total score on the scale of 0-15. Possible scores ranged from 0 to 15, with higher scores representing increased medical knowledge.~The CPR knowledge survey assesses a participants basic understanding of cardiopulmonary resuscitation (CPR). The survey consisted of 12 questions with one point being awarded for each correct response. Question four had a total of four possible correct answers. Thus the scores on the scale of 0-15 points is designed, with higher scores representing increased knowledge."|after admission to ICU, approx one hour||||points||Inter-Quartile Range|Median
2656998|NCT01610063|Secondary|Remitters at Week 8|Definitions of the depression questionnaires are found in previous outcome measures. Definition of remitter: a participant with score less than or equal to certain value (HAMD-17 <=7, QIDS-C16<=5, PHQ-9<5).|baseline, 8 weeks||||percentage of participants|||Number
2656999|NCT01610063|Secondary|Responders at Week 8|Definitions of the depression questionnaires are found in previous outcome measures. Definition of responder: a participant who had 50% or higher reduction in psychiatric score from baseline.|baseline, 8 weeks||||percentage of participants|||Number
2657000|NCT01610063|Secondary|Physicians' Perception of Participant's Satisfaction With Their Care|Physicians reported on their perception of each participant's satisfaction with their care only for patients who completed the 8-week study. Physicians were directed to complete a survey for each participant detaining their experience during the study period.|8-week visit|Physicians completed surveys for 89 participants (96%) from the unguided group, and for 37 participants (51.4%) from the guided group. For each row below, the number of subjects analyzed is indicated by (n=guided, unguided) arms. For the first row, one of the physicians who completed the survey did not answer this question.|||percentage of physicians|||Number
2657001|NCT01610063|Secondary|Pharmacogenomic Report Utilization|Physicians were directed to complete a survey for each participant detailing their experiences during the study period.|baseline, 8-week visit|The medication changes of patients were recorded only for patients who completed the 8-week study (n=72,93 for guided and unguided arms). For each row below, the number of subjects analyzed is indicated by (n=guided, unguided) arms.|||percentage of participants|||Number
2657002|NCT01610063|Secondary|Percentage Change in Outcome by Bin Status and Treatment Group|"The Genesight algorithm presents recommendations for antidepressants and antipsychotics in bin status associated with colors. Green indicates Use as Directed. Yellow indicates Use with Caution. Red indicates Use with Increased Caution and with More Frequent Monitoring. Definitions of the depression questionnaires are found in previous outcome measures. A negative change indicates improvement in the subject's depression/anxiety symptoms, and a positive change indicates a worsening of the subject's depression/anxiety symptoms."|baseline, 8-week visit|All subjects were evaluated for a bin status, but not all the arms had subjects assigned to every bin status (green, yellow, or red). Bin status for each category title is reported as (n=Guided, Unguided).|||Percentage change||Standard Deviation|Mean
2657021|NCT01609933|Secondary|Percentage of Participants Achieving Virologic Response 24 Weeks Post Treatment (SVR24)|SVR24 was defined as HCV RNA level less than the LLOQ 24 weeks after the last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV).|24 weeks after last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV); approximately 48 weeks after subject's initial dose of study drug in Substudy 1|ITT population|||percentage of participants||95% Confidence Interval|Number
2657003|NCT01610063|Secondary|Percentage Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline|The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 27 (severe symptoms) for depression. A negative change indicates improvement in the subject's depression symptoms, and a positive change indicates a worsening of the subject's depression symptoms.|baseline, 8-week visit|There were 8 out of 72 patients in the guided arm and 12 out of 93 patients in the unguided arm who did not have assigned medication color in green/yellow/red. The number analyzed per row is indicated as (n=guided,unguided). One subject in the guided arm (green/yellow) did not complete the PHQ-9 questionnaire at 8 weeks.|||Percentage change in depression rating||Standard Deviation|Mean
2657004|NCT01610063|Secondary|Percentage Change in Hamilton Depression Rating Scale (HAMD-17) Score From Baseline|The HAMD-17 is a 17-item scale that evaluates depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. The 17 items are rated on either a 5-point (0-4) or a 3-point (0-2) scale. In general, the 5 point scale items use a rating of 0=absent; 1=doubtful to mild; 2=mild to moderate; 3=moderate to severe; 4=very severe. The 3-point scale items use a rating of 0=absent; 1=probable or mild; 2=definite. The total HAMD-17 score ranges from 0 (not ill) to 52 (severely ill). A negative change indicates improvement in the subject's depression/anxiety symptoms, and a positive change indicates a worsening of the subject's depression/anxiety symptoms.|baseline, 8-week visit|This analysis was performed on subjects who completed the study. There were 8 out of 72 patients in the guided arm and 12 out of 93 patients in the unguided arm who did not have assigned medication color in green/yellow/red. The number analyzed per row is indicated as (n=guided,unguided).|||Percentage change in depression rating||Standard Deviation|Mean
2657005|NCT01610063|Primary|Percentage Change in Quick Inventory of Depressive Symptomatology (QIDS-C16) Score From Baseline|The QIDS-C16 is a 16-item scale that is clinician-rated; it is designed to assess the severity of depressive symptoms. The QIDS-C16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores >/= 11 correspond to moderate to severe depression. A negative change indicates improvement in the subject's depression, and a positive change indicates a worsening of the subject's depression.|baseline, 8-week visit|This analysis was performed on subjects who completed the study. There were 8 out of 72 patients in the guided arm and 12 out of 93 patients in the unguided arm who did not have assigned medication color in green/yellow/red. The number analyzed per row is indicated as (n=guided,unguided).|||Percentage change in depression rating||Standard Deviation|Mean
2657006|NCT01610037|Secondary|Change From Baseline in 1 Hour Post-dose FEV1 Measurements|The avg 60 min post dose forced expiratory volume in 1 second (FEV1) at visit 4, 5, 6, 7, 8 and 9 will be analyzed.|Day 1, 22, 43, 85, 183, 274 and 364|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum|||Liters||Standard Deviation|Mean
2657007|NCT01610037|Secondary|Time to Premature Discontinuation|Time to premature treatment discontinuation for each treatment group was displayed using a Kaplan-Meier curve. The date of last dose of study medication was considered as the event date and also as the censoring date for those patients who did not discontinue treatment early. The range of the 'time to treatment discontinuation' varied from 5-407 days in the Tiotropium group. Hence the model estimated lower limit of the median time to treatment discontinuation is greater than the scheduled treatment period of 52 weeks.|Time varied from 5 - 407 days|The Safety set consisted of all patients that received at least one dose of study medication and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received.|||Days||95% Confidence Interval|Median
2657008|NCT01610037|Secondary|Change From Baseline in 1 Hour Post-dose Forced Vital Capacity (FVC) Measurements|Pulmonary function assessments were performed using centralized spirometry according to international standards|Day 1, 22, 43, 85, 183, 274 and 364|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum|||Liters||Standard Deviation|Mean
2657009|NCT01610037|Secondary|Change From Baseline in Percentage of Days Able to Perform Usual Daily Activities.|A day able to perform usual daily activities' is defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum|||Percentage of days||Standard Deviation|Mean
2657010|NCT01610037|Secondary|Change From Baseline in Percentage of no Daytime Symptoms|A day with 'no daytime symptoms' is defined from the diary data as any day where the patient has recorded in the evening no cough, no wheeze, no production of sputum and no feeling of breathlessness (other than when running) during the past 12 hours (approx. 8 am to 8 pm).|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum|||Percentage of days||Standard Deviation|Mean
2657011|NCT01610037|Secondary|Change From Baseline in Percentage of Nights With 'no Nighttime Awakenings|A night with 'no nighttime awakenings' is defined from diary data as any night where the patient did not wake up due to symptoms.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum|||Percentage of nights||Standard Deviation|Mean
2658123|NCT01600287|Other Pre-specified|Percentage Fall in MAP During Induction|percentage fall in mean arterial pressure from baseline during induction|15 minutes||||percentage of fall from baseline||Standard Deviation|Mean
2657012|NCT01610037|Secondary|Change From Baseline in Daily, Morning and Evening Symptom Scores|Patients will be provided with an electronic diary (eDiary) to record daily clinical symptoms, or rescue medication. The patients will be instructed to routinely complete the patient diary twice daily. There are 9 total symptom questions for a total possible score of 27 at each timepoint. A higher score means the patient is reporting more symptoms related to Chronic Obstructive Pulmonary Disease. The mean daily total symptom score, the mean daytime total symptom score and the mean nighttime total symptom score were calculated for each patient over 52 weeks. Diary data recorded during the 14 day run-in period were used to calculate the baseline.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum|||Score||Standard Deviation|Mean
2657013|NCT01610037|Secondary|Change From Baseline in Health Status as Measured by St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C)|"The SGRQ-C contains 40 items divided into two parts covering three aspects of health related to COPD: Part I covers Symptoms and is concerned with respiratory symptoms, their frequency and severity; Part II covers Activity and is concerned with activities that cause or are limited by breathlessness; Part II is also concerned with Impacts which covers a range of aspects concerned with social functioning and psychological disturbances resulting from airways disease. A score will be calculated for each of these three subscales and a Total score will also be calculated. In each case the lowest possible value is zero and the highest 100. Higher values correspond to greater impairment of health status."|Measurment at day 364|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum|||Score||Standard Deviation|Mean
2657014|NCT01610037|Secondary|Change From Baseline in Pre-Dose Forced Expiratory Volume Over in Second (FEV1)|Pulmonary function assessments were performed using centralized spirometry according to international standards. Baseline FEV1 was defined as the average of the pre-dose FEV1 measured at -45 minutes (min) and -15 min at day 1.|Day 22, 43, 85, 183, 274 and 364|The full analysis set (FAS) included all randomized patients who eceived at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum|||Liters||Standard Error|Least Squares Mean
2657015|NCT01610037|Secondary|Post-hoc Analysis: Percentage of Patients With Composite Endpoint of Cardiovascular Death and MACE|The composite endpoint included all deaths and all serious CCV events, including MACE and events which were not considered MACE. A rigorous post hoc analysis was done on composite endpoint of CV deaths and major adverse cardiovascular events (MACE). The patients with an event in the analysis were those who had at least one of the 2 events namely, CV deaths and MACE, during treatment or within 30 days after the date of last dose of study drug.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum.|||Percentage of participants|||Number
2657016|NCT01610037|Secondary|Percentage of Patients With Composite Endpoint of All-cause Mortality, and Serious Cardio- and Cerebrovascular (CCV) Events.|The endpoint of all-cause mortality and serious CCV events (composite) was chosen to further characterize any discernible risks. The patients with an event in the analysis were those who had at least one of the 2 events namely, all-cause mortality and serious CCV, during treatment or within 30 days after the date of last dose of study drug.|52 weeks|The full analysis set (FAS) included all randomized patients who received at least one dose of study drug. Patients were analyzed according to the treatment they were assigned to at randomization. If the patient was assigned to the wrong stratum for randomization, the patient was analyzed according to the actual (rather than assigned) stratum.|||Percentage of participants|||Number
2657017|NCT01610037|Primary|Number of Patients With Serious Adverse Events|The overall rate of serious adverse events reported from initiation through 30 days post last dose.|Week 52|The safety set included all patients who received at least one dose of study drug and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. A patient who had no adverse events also constitutes a safety assessment.|||Participants|||Number
2657018|NCT01610011|Primary|Brain Glycine Increments After Oral Glycine Administration Measured With MRS as Glycine/Total Creatine, Normalized to the Glycine Dose Administered (g/kg).|Brain and plasma glycine levels are measured with proton magnetic resonance spectroscopy at 4T and analytically, respectively. Because glycine doses were limited to 30 g to avoid nausea and vomiting, some subjects with higher weights were administered lower doses per body weight of glycine (g/kg). Therefore, we corrected MRS data by the actual glycine dose administered (g/kg) to account for dosing differences.|For up to 2 hours|Subjects completing the magnetic resonance spectroscopy study.|||Percent brain glycine/creatine increase|Participants|Standard Error|Mean
2657019|NCT01609933|Secondary|Number of Participants With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after initiation of study drug through 30 days post-DAA dosing. For more details on AEs, see the AE section.|From first dose of study drug through 30 days after last dose of study drug (DAAs plus pegIFN alpha-2a and RBV) (up to 28 weeks).|Safety population (all subjects who received at least 1 dose of study drug)|||participants|||Number
2657022|NCT01609933|Primary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post Treatment (SVR12)|SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level less than lower limit of quantitation [LLOQ] 12 weeks after the last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV).|12 weeks after last dose of study drugs (DAAs plus pegIFN alpha-2a and RBV); approximately 36 weeks after subject's initial dose of study drug in Substudy 1|ITT population|||percentage of participants||95% Confidence Interval|Number
2657023|NCT01609842|Secondary|Mortality|Mortality|12 months post PCI discharge||||Participants|||Count of Participants
2657024|NCT01609842|Secondary|Hospitalizations|Number of participants with hospitalizations|12 months post PCI discharge||||Participants|||Count of Participants
2657025|NCT01609842|Primary|Mean PDC|Proportion of days covered. The number of days that the patient had a pill to take divided by the number of days of follow-up (follow-up terminated at death or at 365 days).|12 months post PCI discharge||||proportion of days covered||Standard Deviation|Mean
2657026|NCT01609842|Primary|Percentage of Participants With Anti-Platelet Medication Delay|Percentage of Participants with Anti-Platelet Medication Delay. Delay is defined as filling anti-platelet medication >1 day after PCI discharge and not filling the anti-platelet medication prescription by the refill date|12 months post PCI discharge||||Participants|||Count of Participants
2657027|NCT01609842|Primary|Percentage of Adherent Patients|Percentage of patients whose clopidogrel prescription is filled at hospital discharge following the PCI stent placement as well as the percentage of patients who are adherent based on the pharmacy refill data in the year after hospital discharge. We used mixed logistic regression models for clopidogrel adherence (y/n PDC > 80%) as planned.|12 months post PCI discharge||||Participants|||Count of Participants
2657028|NCT01609790|Other Pre-specified|Tumor Genotype, Expression Profile, and Circulating Angiogenesis Biomarkers (Cohort 2)|Biomarker data has not yet been obtained and therefore this outcome measure cannot yet be reported.|From randomization to date of death or last followup. Statistical analysis occurs when tumor genotype, expression profile and circulating angiogenesis biomarkers have been determined from the tissue specimens.|||||||
2657029|NCT01609790|Secondary|Percentage of Patients Requiring Dose Reduction/Interruption or Discontinuation in the First 2 and Subsequent Courses (Cohort 1)|Feasibility of trebananib weekly in combination with bevacizumab every 2 weeks, measured by the percentage of patients requiring dose reduction/interruption or discontinuation in the first 2 and subsequent courses (Cohort 1)|From randomization up to 3 years.|Eligible patients|||Participants|||Count of Participants
2657030|NCT01609790|Secondary|Radiographic Response Rate (Cohort 2)|Proportion of patients with best overall response of complete response (CR) or partial response (PR) recorded from the start of the treatment until disease progression/recurrence. Response determined by site-reported radiology review of MRI exams using Response Assessment in Neuro-Oncology Criteria (RANO) criteria. CR: Complete disappearance of all enhancing measurable disease (MD) + non-measurable disease (NMD) sustained >= 4 wks; No new lesions; Stable or improved non-enhancing (T2/FLAIR) lesions; Off corticosteroids (or on physiologic replacement doses only); Stable/improved clinically. PR: >= 50% decrease vs. baseline of sum of products of perpendicular diameters of all measurable enhancing lesions sustained >= 4 wks; No progression of NMD; No new lesions; Stable/improved non-enhancing (T2/FLAIR) lesions on <= dose of corticosteroids vs. baseline scan; Corticosteroid dose at evaluation scan <= baseline scan dose; Stable or improved clinically. NMD only cannot be a CR or PR.|From randomization up to 3 years.|All randomized and eligible patients.|||percentage of participants||95% Confidence Interval|Number
2657031|NCT01609790|Secondary|Progression-free Survival (Cohort 2)|Progression-free survival time is measured from randomization to the date of first progression or death or, otherwise, the last follow-up date on which the patient was reported alive. This analysis was planned to occur when all patients had been potentially followed for at least 6 months.|From randomization up to 3 years.|All randomized and eligible patients.|||percentage of participants||95% Confidence Interval|Number
2657032|NCT01609790|Secondary|Overall Survival (Cohort 2)|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 6 months.|From randomization up to 3 years.|All randomized and eligible patients.|||Months||95% Confidence Interval|Median
2657033|NCT01609790|Secondary|Incidence of Grade 3+ Treatment-related Toxicity, Measured by CTCAE v. 4 (Cohort 2)|Adverse events (AEs) are graded by using CTCAE 4.0. Possibly/probably/definitely related to protocol treatment AEs are considered.|From start of treatment up to 3 years.|Randomized and eligible patients who started protocol treatment.|||participants|||Number
2657034|NCT01609790|Primary|Six-month Progression-free Survival (Cohort 2)|As determined by central review of MRI exams, assessed using RANO criteria for progression that is defined by any of the following: > 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared to the smallest tumor measurement obtained either at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids; Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids compared to baseline scan or best response following initiation of therapy, not due to co-morbid events; Any new lesion; Clear clinical deterioration not attributable to other causes apart from the tumor or changes in corticosteroid dose; Failure to return for evaluation due to death or deteriorating condition; Clear progression of non-measurable disease.|From randomization to six months.|Randomized patients evaluable for 6 months progression-free survival (PFS).|||percentage of participants||95% Confidence Interval|Number
2657044|NCT01609478|Secondary|Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period|Time to permanent study discontinuation due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||days||95% Confidence Interval|Median
2657035|NCT01609790|Primary|Number of Patients Experiencing of Dose-limiting Toxicity (Cohort 1)|Dose-limiting toxicity (DLT), defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and meets any of the criteria below. Any DLT must be a toxicity possibly related to protocol treatment during first 4 weeks: grade 4 hematologic toxicity, grade 3/4 thrombocytopenia, or grade 3/4 non-hematologic toxicity; Gastrointestinal fistula, bowel perforation, intracranial hemorrhage, wound dehiscence, or reversible posterior leukoencephalopathy of any grade; Delay of treatment > 28 days. If 2+ of patients experience a DLT among 6 eligible patients, this drug combination will be considered unsafe and a lower dose of AMG will be explored; otherwise conclude that this drug combination is safe. The probability of claiming safe dose is no more than 16% when the true DLT rate is >45%, and the probability of claiming safe dose is at least 78% when the true DLT rate is <= 15%.|From start of treatment to 4 weeks.|All eligible patients who started study treatment|||participants|||Number
2657036|NCT01609582|Secondary|Time to First Occurrence of Any Component of Secondary Major Adverse Cardiovascular Event (MACE) Composite|The time from randomization to the first occurrences of any event in the secondary MACE composite was evaluated using Kaplan-Meier analysis. The secondary MACE composite comprised CV death, nonfatal MI, and nonfatal stroke.|Baseline up to end of study (up to Day 588)|Full Analysis Set (FAS) included all randomized participants who had baseline and at least 1 post-baseline assessment.|||days||95% Confidence Interval|Median
2657037|NCT01609582|Primary|Time to First Occurrence of Any Component of Primary Major Adverse Cardiovascular Event (MACE) Composite|The time from randomization to the first occurrences of any event in the primary MACE composite was evaluated using Kaplan-Meier analysis. The primary MACE composite comprised cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, and hospitalization for unstable angina (with or without revascularization).|Baseline up to end of study (up to Day 588)|Full Analysis Set (FAS) included all randomized participants who had baseline and at least 1 post-baseline assessment.|||days||95% Confidence Interval|Median
2657038|NCT01609543|Secondary|Percentage of Participants Who Were Alive at 1 Year||1 Year (12 months)|ITT population. Here, number of participants analyzed signifies those participants who were evaluable for this outcome.|||Percentage of Participants|||Number
2657039|NCT01609543|Secondary|Percentage of Participants With Best Overall Response (BOR)|BOR was defined as best tumor response (as per RECIST version 1.1) recorded for a participant during the study. Complete Response (CR): disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than [<] 10 millimeters [mm] short axis). Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline to progressive disease or death (up to 34 months)|ITT population.|||Percentage of Participants|||Number
2657040|NCT01609543|Primary|Progression-Free Survival (PFS)|PFS was defined as median time from the first dose of study treatment to the first documentation of objective tumor progression (according to Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) or to death due to any cause, whichever occurred first. Progressive Disease (PD) was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Median and the 95% confidence interval were estimated using Kaplan-Meier survival methodology.|Baseline to progressive disease or death (up to 34 months)|ITT population.|||Months||95% Confidence Interval|Median
2657041|NCT01609478|Secondary|Plasma Indacaterol Concentrations at Day 1 and Day 14|Maximum plasma concentration after drug administration (Cmax) was measured for indacaterol acetate 75 µg and indacaterol acetate 150 µg for Pharmacokinetic (PK) Subgroup|Day 1 and Day 14|Pharmacokinetic (PK) profiling subgroup included all randomized patients who consented to participate in the additional PK assessment.|||pg/ml||Standard Deviation|Mean
2657042|NCT01609478|Secondary|Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period|Total amounts (in doses) of systemic corticosteroids (SCS) used to treat asthma exacerbations.SCS includes Intramuscular (IM), Intravenous (IV) and Oral. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||milligrams (mg)||Standard Deviation|Mean
2657043|NCT01609478|Secondary|The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period|The percentage of patients who permanently discontinued study due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||percentage of participants|||Number
2657064|NCT01609296|Secondary|Primary Sustained Clinical Improvement|Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.|12 months.||||Participants|||Count of Participants
2657045|NCT01609478|Secondary|The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period|The percentage of patients with at least one asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||percentage of participants|||Number
2657046|NCT01609478|Secondary|Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period|Duration of asthma exacerbations by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||days||Standard Deviation|Mean
2657047|NCT01609478|Secondary|The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period|Annual incidence rate of asthma exacerbation by severity of exacerbation. The number of asthma exacerbation is used to calculate annual incidence rate. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations. Number of the asthma exacerbation will be analyzed by the negative binomial regression including treatment, history of asthma exacerbation in the 12 months prior to screening and region as factors and FEV1 prior to inhalation and FEV1 30 min post inhalation of salbutamol/albuterol (components of SABA reversibility) as covariates. The estimates are obtained from the model and so we cannot specify a formula.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||# of exacerbations||95% Confidence Interval|Number
2657048|NCT01609478|Secondary|Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period|Duration of treatment until first asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is systemic corticosteroids (SCS) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||weeks||95% Confidence Interval|Median
2657049|NCT01609478|Secondary|Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment|The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.|4 Weeks, 12 Weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
2657050|NCT01609478|Secondary|The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment|Participants record the number of puffs of rescue medication taken in the previous 12 hours in the morning and nighttime.|12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||number of puffs||Standard Deviation|Least Squares Mean
2657051|NCT01609478|Secondary|Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.|PEFR is measured with portable spirometer by participants every morning and evening at home.|baseline, 4weeks, 8 weeks and 12 weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||liters/second||Standard Error|Least Squares Mean
2657052|NCT01609478|Secondary|Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment|The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).|after 4 weeks (Day 29) and after 8 weeks (Day 57)|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||units on a scale||Standard Error|Least Squares Mean
2657065|NCT01609296|Secondary|TVR|Any Target vessel revascularisation|12 months.||||Participants|||Count of Participants
2657053|NCT01609478|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)|Peak Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Peak FEV1 is defined as the maximum FEV1 during the first 4 h post morning dosing at Day 1, 2Weeks and 12 Weeks.|Day 1, 2 weeks (Day 14), 12 weeks (Day 84)|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||liters||Standard Error|Least Squares Mean
2657054|NCT01609478|Secondary|Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)|Forced Expiratory Volume in 1 second (FEV1)/Area Under the Curve(AUC) was measured via spirometry conducted according to internationally accepted standards.FEV1 AUC(5 min - 4 h), (5 min - 1 h) and (1 h - 4 h) are measured at Day 1, 2 Weeks (Day 14) and 12 Weeks (Day84) and defined as average of FEV1 at specified timepoints above.|Day 1, 2 Weeks, 12 Weeks|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||Liters||Standard Error|Least Squares Mean
2657055|NCT01609478|Secondary|Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|Forced Expiratory Flow (FEF 25-75%) was measured via spirometry conducted according to internationally accepted standards.|Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||liters/second||Standard Error|Least Squares Mean
2657056|NCT01609478|Secondary|Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards.|Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||ratio||Standard Error|Least Squares Mean
2657057|NCT01609478|Secondary|Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points|Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. FVC is measured on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at all time points|Day 1, Day 2, Day 14, Day 15, Day 84, Day 85|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||liters||Standard Error|Least Squares Mean
2657058|NCT01609478|Secondary|Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.|Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 2 weeks (Day 15), 4 weeks (Day 29), and 8 weeks (Day 57) of treatment.|Day 15, Day 29 and Day 57|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||Liters||Standard Error|Least Squares Mean
2657059|NCT01609478|Secondary|Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)|The Asthma Control Questionnaire (ACQ-5) is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.|aftert 12 weeks (Day 85)|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
2657060|NCT01609478|Primary|Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)|Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 12 weeks (Day 85)|after 12 weeks (Day 85)|The Full Analysis Set (FAS) included all randomized who received at least one dose of study drug with available data for analysis. Participants from FAS were considered for this analysis, however for a given time point participants analyzed had a value at such timepoint.|||Liters||Standard Error|Least Squares Mean
2657061|NCT01609348|Primary|Changes in Dose Response Using the Modified Alzheimer's Disease (AD) Cooperative Study-Clinical Global Impression of Change.|"Treatment will be considered efficacious if the proportion of worse categories (including 'minimal worsening', 'moderate worsening', or 'marked worsening') is lower under treatment than control on the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change.~Clinical Global Impression of Change: This is a 7-item score ranging from markedly worse to markedly improved. It is assessed by the study clinician who interviews both participant and informant and makes an informed judgment how to incorporate their input"|12 weeks||||Participants|||Count of Participants
2657062|NCT01609296|Secondary|Clinical Success|Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge|prior to discharge||||Participants|||Count of Participants
2657063|NCT01609296|Secondary|Device Success|Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)|Index-procedure||||Admiral™ Drug-Eluting Balloon|Admiral™ Drug-Eluting Balloon||Count of Units
2657067|NCT01609296|Secondary|MAEs|MAE (Major Adverse Events)is defined as all-cause mortality, clinically-driven TVR (Target Vessel Revascularization), major target limb amputation, thrombosis at the target lesion site.|12 months|Event rates are based on number of evaluable subjects – subjects with at least one MAE event within 360-day or subjects without any MAE event but had at least 300 days of clinical follow-up.|||Participants|||Count of Participants
2657068|NCT01609296|Primary|Primary Safety Endpoint|A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure.|12 months||||Participants|||Count of Participants
2657069|NCT01609296|Primary|Primary Endpoint Clinical Cohort|Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or > 0.15 when compared to post-index procedure baseline ABI.|12 months||||Participants|||Count of Participants
2657070|NCT01609257|Secondary|Percentage of Participants With Unsolicited Non-Serious [i.e Other Than SAEs] Adverse Events (AEs)|Unsolicited AEs indicates any and all AEs that occurred other than those that were solicited.|Vaccination Stage: Initial vaccination until 28 days after second vaccination; or Challenge Stage: the day of challenge until 60 days after challenge|MITT population included all participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2657071|NCT01609257|Secondary|HBGA (PGM) - Anti-Norovirus GII.4 cVLP GMT||Baseline, 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||titer||95% Confidence Interval|Geometric Mean
2657072|NCT01609257|Secondary|Percentage of Participants With HBGA (PGM) - Anti-Norovirus GII.4 cVLP Seroresponse From Baseline|Seroresponse was defined as a 4-Fold Rise from Baseline.|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2657073|NCT01609257|Secondary|HBGA (PGM) - Anti-Norovirus GII.4 cVLP GMFR From Baseline||Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||ratio||95% Confidence Interval|Geometric Mean
2657074|NCT01609257|Secondary|HBGA (PGM) - Anti-Norovirus GI.1 VLP GMT||Baseline, 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||titer||95% Confidence Interval|Geometric Mean
2657075|NCT01609257|Secondary|Percentage of Participants With HBGA (PGM) - Anti-Norovirus GI.1 VLP Seroresponse From Baseline|Seroresponse was defined as a 4-Fold Rise from Baseline|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2657076|NCT01609257|Secondary|HBGA (PGM) - Anti-Norovirus GI.1 VLP GMFR From Baseline|HBGA (PGM) is Histoblood Group Antigen (Pig Gastric Mucin).|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||ratio||95% Confidence Interval|Geometric Mean
2657077|NCT01609257|Secondary|ELISA IgA- Anti-Norovirus GII.4 cVLP GMT||Baseline, 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||titer||95% Confidence Interval|Geometric Mean
2657078|NCT01609257|Secondary|Percentage of Participant With ELISA IgA- Anti-Norovirus GII.4 cVLP Seroresponse From Baseline|Seroresponse was defined as a 4-Fold Rise from Baseline.|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2657079|NCT01609257|Secondary|ELISA IgA- Anti-Norovirus GII.4 cVLP GMFR From Baseline||Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||ratio||95% Confidence Interval|Geometric Mean
2657080|NCT01609257|Secondary|ELISA IgA- Anti-Norovirus GI.1 VLP Geometric Mean Titer (GMT)||Baseline, 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||titer||95% Confidence Interval|Geometric Mean
2657081|NCT01609257|Secondary|Percentage of Participants With ELISA IgA- Anti-Norovirus GI.1 VLP Seroresponse (4-fold Rise) From Baseline||Baseline to 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2657082|NCT01609257|Secondary|ELISA Immunoglobulin A (IgA)- Anti-Norovirus GI.1 VLP Geometric Mean Fold Rise (GMFR) From Baseline||Baseline to 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||ratio||95% Confidence Interval|Geometric Mean
2657083|NCT01609257|Secondary|Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP GMT||Baseline, 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||titer||95% Confidence Interval|Geometric Mean
2657084|NCT01609257|Secondary|Percentage of Participants With Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP Seroresponse From Baseline|Seroresponse was defined as a 4-Fold Rise from Baseline.|Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2657085|NCT01609257|Secondary|Pan-Ig ELISA - Anti-Norovirus GII.4 cVLP GMFR From Baseline||Baseline to 28 days post Dose 1 and 28 days post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||ratio||95% Confidence Interval|Geometric Mean
2668018|NCT01509677|Secondary|Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (Alfa-2-Macroglobulin (µg/mL))||Baseline to 14 weeks||||µg/mL||Standard Error|Least Squares Mean
2657087|NCT01609257|Secondary|Percentage of Participants With Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Seroresponse (4-fold Rise) From Baseline||Baseline, 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2657088|NCT01609257|Secondary|Pan-Ig ELISA - Anti-Norovirus GI.1 VLP Geometric Mean Fold Rise (GMFR) From Baseline||Baseline to 28 days Post Dose 1 and 28 days Post Dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||ratio||95% Confidence Interval|Geometric Mean
2657089|NCT01609257|Other Pre-specified|Correlation of GII.4 Serum HGBA Antibodies Prior to Challenge Associated With Protection From GII.4 Infection|Percentage of placebo subjects HBGA seropositive pre-challenge by infection status.|Pre Challenge to Day 30 Post Challenge|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||percentage of participants|||Number
2657090|NCT01609257|Other Pre-specified|Correlation of GII.4 Serum HBGA Antibodies Prior to Challenge Associated With Protection From GII.4 Illness|Percentage of placebo subjects HBGA seropositive pre-challenge by illness status.|Pre Challenge to Day 30 Post Challenge|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||percentage of participants|||Number
2657091|NCT01609257|Secondary|Percentage of Participants With GII.4 Seroresponse Rate (4-fold Rise) From Pre-challenge Day 0 to Post-Challenge Day 30|Seroresponse was a 4-fold increase in IgG ELISA anti-GII.4 norovirus P particle antibody titer from pre-challenge to post-challenge.|Pre Challenge to 30 Days Post Challenge|Participants from the MITT population, all participants who received at least one dose of study drug, with data available for analysis.|||percentage of participants||95% Confidence Interval|Number
2657092|NCT01609257|Secondary|Percentage of Participants With GII.4 Norovirus Positive RT-PCR in the Stool During the Inpatient and /or Outpatient Phase||Pre Challenge to 30 Days Post Challenge|Participants from the MITT population, all participants with at least one dose of study drug, challenge stage with data available for analysis.|||percentage of participants|||Number
2657093|NCT01609257|Secondary|Duration of Viral AGE Due to GII.4 Strain During the Inpatient Phase|Duration of symptoms was determined by a blinded committee review of each participant's symptoms.|Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)|Participants from the MITT population, all participants who received at least one dose of study drug, challenge stage with Viral AGE.|||hours||Full Range|Median
2657094|NCT01609257|Secondary|Severity of Viral AGE Due to GII.4 Strain Assessed by Post-Challenge Symptom Collection During the Inpatient Phase|Score 1 was based on a subset of symptoms including: elevated oral temperature, myalgia, nausea, abdominal cramps, bloating, diarrhea, and vomiting. Score 2 was based on all Score 1 symptoms plus fatigue/malaise, chills, and loss of appetite. Total Score 1=0 to 20 and Total Score 2=0 to 29. Higher numbers are worse.|Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)|Participants from the MITT population, all participants who received at least one dose of study drug, challenge stage with Viral AGE.|||score on a scale||Standard Deviation|Mean
2657095|NCT01609257|Secondary|Severity of Viral AGE Due to GII.4 Strain Assessed by Modified Vesikari Scoring System During the Inpatient Phase|Vesikari Scoring System assesses the following symptoms: duration of diarrhea (days), maximum number of diarrheal stools/24 hours, duration of vomiting (days), maximum number of vomiting episodes/24 hours, fever and dehydration. Since the typical inpatient phase was four days in length, the duration of diarrhea scoring was modified to fit this time frame. Modified Vesikari Scale Total Score=0 to 17. Higher numbers are worse.|Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)|Participants from the MITT population, all participants who received at least one dose of study drug, challenge stage with Viral AGE.|||score on a scale||Standard Deviation|Mean
2657096|NCT01609257|Secondary|Percentage of Participants With 4-Fold Rise In Serum P-Particle Antibody Titer by ELISA or Detection of Norovirus GII.4 by RT-PCR in the Stool||Pre Challenge to 30 Days Post Challenge|MITT population included all participants who received at least one dose of study drug, Challenge stage.|||percentage of participants|||Number
2657097|NCT01609257|Primary|Percentage of Participants With Serious Adverse Events (SAEs) 365 Days Following the Last Study Vaccination|A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|365 Days Following Dose 2 (Up to 393 days)|MITT population included all participants who received at least one dose of study drug.|||percentage of participants|||Number
2657098|NCT01609257|Primary|Percentage of Participants Experiencing Solicited Systemic Adverse Events Within 7 Days Post-Dose 2|Systemic signs or symptoms included: elevated fever, headache, fatigue, muscle aches, chills, joint aches and gastrointestinal symptoms of nausea, vomiting, diarrhea, abdominal cramps/pain.|Within 7 days post-dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, who received a second dose.|||percentage of particpants||95% Confidence Interval|Number
2657099|NCT01609257|Primary|Percentage of Participants Experiencing Solicited Systemic Adverse Events Within 7 Days Post-Dose 1|Systemic signs or symptoms included: elevated daily oral temperature (fever), headache, fatigue, muscle aches, chills, joint aches and gastrointestinal symptoms of nausea, vomiting, diarrhea, abdominal cramps/pain.|Within 7 days post-dose 1|MITT included all participants who received at least one dose of study drug. Data is missing for 2 participants.|||percentage of particpants||95% Confidence Interval|Number
2657100|NCT01609257|Primary|Percentage of Participants Experiencing Solicited Local Adverse Events Within 7 Days Post-Dose 2|Local Adverse Events included local injection site reactions/symptoms: pain, tenderness, redness, and swelling.|Within 7 days post-dose 2|Participants from the MITT population, all participants who received at least one dose of study drug, who received a second dose.|||percentage of participants||95% Confidence Interval|Number
2657235|NCT01607450|Secondary|Cardiac Index|Impedance cardiography-derived measurement of cardiac index, assessed following 12 hour exposure to treatment condition concurrent with the PET measurements.|After 12 hours of GLP-1 exposure|Analyses performed only on the groups with relevant primary outcome data observed|||L/min/m^2||Standard Deviation|Mean
2657101|NCT01609257|Primary|Percentage of Participants Experiencing Solicited Local Adverse Events Within 7 Days Post-Dose 1|Local Adverse Events included local injection site reactions/symptoms: pain, tenderness, redness, and swelling.|Within 7 days post-dose 1|MITT population included all participants who received at least one dose of study drug. Data is missing for 2 participants.|||percentage of participants||95% Confidence Interval|Number
2657102|NCT01609257|Primary|Percentage of Participants With Viral AGE Clinical Illness and Fecal Virus Excretion Detected by RT-PCR OR 4-Fold Rise In Anti-GII.4 Norovirus P Particle Antibody Titer|Viral AGE due to Norovirus GII.4 strain during the inpatient stay that meets clinical illness definition 1,2 or 3 and positive for infection as measured by fecal virus excretion detected by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) OR a 4-fold rise in Immunoglobulin G Enzyme-Linked Immunosorbent Assay (IgG ELISA) anti-GII.4 norovirus P particle antibody titer from pre-challenge (Within 2 weeks of Challenge Day 0) to post-challenge (Challenge Day 30). The clinical illness definitions are 1: diarrhea (defined as ≥ 3 loose or liquid stools OR >400-600 grams of loose or liquid stools produced in any 24-hour period), 2: vomiting (defined as ≥ 2 vomiting episodes in any 24-hour period) or 3. One Vomiting episode plus any loose or liquid stool in any 24-hour period OR one vomiting episode plus at least 2 of the following 5 events: nausea, fever ≥99.7°F orally, abdominal cramps or pains, abdominal gurgling or bloating, or myalgia in any 24-hour period.|Symptoms collected from Challenge dose (at least 28 days after dose 2) to discharge (at least 96 hours after challenge dose)|Modified intent-to-treat population (mITT) included all participants who received at least one dose of study drug, challenge stage.|||percentage of participants|||Number
2657103|NCT01609062|Secondary|Adolescent Pediatric Pain Tool (APPT) - Pain Intensity|"The APPT is a validated, multidimensional tool to evaluate pain in children, adolescents, and young adults. The complete APPT is measured in three parts - Part 1 of the APPT scale determines the subject's pain locations using a body template. Part 2 of the APPT scale determines the intensity of the pain using a 10 cm visual analog scale (VAS) with the lowest point of the scale (0) labeled No Pain and the highest point on the scale (10) labeled Worst Possible Pain. Intermediate regions of the sale were labeled with 3 intermediate descriptors (Little Pain, Medium Pain, and Large Pain). Part 3 of the APPT scale characterizes the pain by tracking the number and percentage of words selected by subjects to describe their pain from a total of 57 choices. Part 2 corresponds most closely to other typically used pain scales (based on VAS) and for this reason the results from Part 2 are presented here.~Change from baseline to Week 12, 24, and 52 in pain intensity."|Baseline, Week 12, 24, and 52|Modified Intent-to-treat|||units on a scale||Standard Deviation|Mean
2657104|NCT01609062|Secondary|Muscle Strength Testing (MST) - Elbow Flexion Test|Percent change from baseline to Week 25 and 52 as measured by the peak force in MST elbow flexion test (newton meters).|Baseline, Week 25 and 52|Modified Intent-to-treat Analysis Set|||Percent Change||Standard Deviation|Mean
2657105|NCT01609062|Secondary|Muscle Strength Testing (MST) - Knee Flexion Test|Percent change from baseline to Week 25 and 52 as measured by the peak force in MST knee flexion test (newton meters).|Baseline, Week 25 and 52|Modified Intent-to-treat Analysis Set|||Percent Change||Standard Deviation|Mean
2657106|NCT01609062|Secondary|Muscle Strength Testing (MST) - Knee Extension Test|Change from baseline to Week 25 and 52 as measured by the peak force in MST knee extension test (newton meters).|Baseline, Week 25 and 52|Modified Intent-to-treat Analysis Set|||Percent Change||Standard Deviation|Mean
2657107|NCT01609062|Secondary|Cardiopulmonary Exercise Testing (CPET) - Aerobic Efficiency|"Subjects performed maximal incremental exercise testing using an electronically braked upright cycle ergometer. Cycle ergometry is a method of CPET that may be feasible in subjects who have orthopedic, peripheral vascular, or neurological limitations that restrict weight bearing.~Percent change from baseline to Week 25 and 52 as measured by the CPET Aerobic Efficiency (ml/watt).~Note that decline in Aerobic Efficiency translate into an improvement"|Baseline, Week 25 and 52|A subset of mITT subjects who were scheduled to perform CPET|||Percent Change||Standard Deviation|Mean
2657108|NCT01609062|Secondary|Cardiopulmonary Exercise Testing (CPET) - O2 Pulse|"Subjects performed maximal incremental exercise testing using an electronically braked upright cycle ergometer. Cycle ergometry is a method of CPET that may be feasible in subjects who have orthopedic, peripheral vascular, or neurological limitations that restrict weight bearing.~Percent change from baseline to Week 25 and 52 as measured by the CPET O2 pulse (ml/beat)"|Baseline, Week 25 and 52|A subset of mITT subjects who were scheduled to perform CPET|||Percent Change||Standard Deviation|Mean
2657109|NCT01609062|Secondary|Cardiopulmonary Exercise Testing (CPET) - Peak Workload|"Subjects performed maximal incremental exercise testing using an electronically braked upright cycle ergometer. Cycle ergometry is a method of CPET that may be feasible in subjects who have orthopedic, peripheral vascular, or neurological limitations that restrict weight bearing.~Percent change from baseline to Week 25 and 52 as measured by the CPET Peak workload (watt)"|Baseline, Week 25 and 52|A subset of mITT subjects who were scheduled to perform CPET|||Percent Change||Standard Deviation|Mean
2657110|NCT01609062|Secondary|Cardiopulmonary Exercise Testing (CPET) - Duration of Exercise|"Subjects performed maximal incremental exercise testing using an electronically braked upright cycle ergometer. Cycle ergometry is a method of CPET that may be feasible in subjects who have orthopedic, peripheral vascular, or neurological limitations that restrict weight bearing.~Change from baseline to Week 25 and 52 as measured by the CPET Duration of Exercise (min)"|Baseline, Week 25 and 52|A subset of mITT subjects who were scheduled to perform CPET|||Percent Change||Standard Deviation|Mean
2657111|NCT01609062|Secondary|Normalized Urine Keratan Sulfate (uKS)|"Urinary KS was measured by a quantitative method and normalized using the sample urinary creatinine measurement.~Percent change from baseline to Week 12, 24, and 52 in normalized urine keratan sulfate (ug/mg)."|Baseline, Week 12, 24, and 52|Modified Intent-to-treat Analysis Set|||Percent Change||Standard Deviation|Mean
2657112|NCT01609062|Secondary|Respiratory Function Test (MVV and FVC)|"Respiratory Function was assessed by spirometry in accordance with American Thoracic Society standards.~Percent change from baseline to Week 12, 24, and 52 as measured by Maximum Voluntary Ventilation (MVV, L/min) Percent change from baseline to Week 12, 24, and 52 as measured by Forced Vital Capacity (FVC, L)"|Baseline, Week 12, 24, and 52|Modified Intent-to-treat Analysis Set|||Percent Change||Standard Deviation|Mean
2657113|NCT01609062|Secondary|3-minute Stair Climb Test (3MSCT)|Change from baseline to Week 12, 24, and 52 as measured in speed (stairs/min) in 3MSCT.|Baseline, Week 12, 24, and 52|Modified Intent-to-Treat Analysis Set|||stairs/min||Standard Deviation|Mean
2657115|NCT01609062|Primary|Safety Evaluation|"The primary objective of the study is to evaluate the safety of weekly infusions of BMN 110; the safety variables included Adverse Events (AEs).~The primary outcome measure data is presented in more detail under the Adverse Events section."|Entire Study Period, up to 192 weeks or ETV (early termination visit)|The primary outcome measure data is presented in more detail under the Adverse Events section.|||participants|||Number
2657116|NCT01609023|Secondary|Time to Progression (TTP) Assessed Using Local Standards|TTP is defined as the time from enrollment to the PD. PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Kaplan-Meier estimate was used for analysis.|From enrollment until disease progression or death, assessed up to 26 months|ITT population|||months||95% Confidence Interval|Mean
2657117|NCT01609023|Secondary|Percentage of Participants With PR Assessed Using Local Standards|Percentage of participants with PR as determined by the investigator was reported. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.|Months 6, 12, 18, and 24|ITT population. Here, ‘Overall Number of Participants Analyzed’ = number of participants who were evaluable for this outcome. ‘Number Analyzed’ = participants who were evaluable for specified timepoints.|||percentage of participants|||Number
2657118|NCT01609023|Secondary|Percentage of Participants With CR Assessed Using Local Standards|Percentage of participants with CR as determined by the investigator was reported. CR was defined as disappearance of all target lesions.|Months 6, 12, 18, and 24|ITT population. Here, ‘Overall Number of Participants Analyzed’ = number of participants who were evaluable for this outcome. ‘Number Analyzed’ = participants who were evaluable for specified timepoints.|||percentage of participants|||Number
2657119|NCT01609023|Secondary|Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) Assessed Using Local Standards|Percentage of participants with CR or PR as determined by the investigator was reported. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.|Months 6, 12, 18, and 24|ITT population. Here, ‘Overall Number of Participants Analyzed’ = number of participants who were evaluable for this outcome. ‘Number Analyzed’ = participants who were evaluable for specified timepoints.|||percentage of participants|||Number
2657120|NCT01609023|Secondary|Percentage of Participants With Disease Progression or Death Assessed Using Local Standards|PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Months 6, 12, 18, and 24|ITT population. Here, ‘Overall Number of Participants Analyzed’ = number of participants who were evaluable for this outcome. ‘Number Analyzed’ = participants who were evaluable for specified timepoints.|||percentage of participants|||Number
2657121|NCT01609023|Secondary|Progression-Free Survival (PFS) Assessed Using Local Standards|PFS was defined as the time from enrollment to the first documented progression of disease or death due to any cause. Progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. KaplanMeier estimate was used for analysis.|From enrollment until disease progression or death, assessed up to 24 months|ITT population|||months||95% Confidence Interval|Median
2657122|NCT01609023|Primary|Percentage of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 24 months|Safety population included all eligible participants.|||percentage of participants|||Number
2657123|NCT01609010|Secondary|Overall Survival|The median time, in months, from randomization to OS event assessed using Kaplan-Meier estimates. One month=30.4 days|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population|||months||Full Range|Median
2657124|NCT01609010|Secondary|Overall Survival (OS) - Percentage of Participants With an Event|An overall survival event was defined as death due to any cause.|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population|||percentage of participants|||Number
2657125|NCT01609010|Secondary|Time to Disease Progression|The median time, in months, from randomization to disease progression event assessed using Kaplan-Meier estimates. One month=30.4 days|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population|||months||95% Confidence Interval|Median
2657126|NCT01609010|Secondary|Disease Progression - Percentage of Participants With an Event|A disease progression event was defined as tumor progression or death due to any cause (or a censored observation).|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population|||percentage of participants|||Number
2657127|NCT01609010|Secondary|Duration of Response|The median time, in months, from the date of the first observation of CR, CRu, or PR and the date of progressive disease (PD), censored observation, or death due to any cause. PD was defined as an increase of >50% compared to BL in the sum of the product of the two largest perpendicular parameters of measurable lymphoma, or the occurrence of new lesions. One month=30.4 days. Response duration was calculated amongst responders (CR+CRu+PR) with cutoffs for follow-up applied.|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population; n=number of participants assessed for the specified parameter at a given visit. Only participants with a response (CR+CRu+PR, CR+CRu, or CR only) were included in the analysis.|||months||95% Confidence Interval|Median
2657128|NCT01609010|Secondary|Duration of Response - Percentage of Participants With an Event|Response duration was defined as the period between the date for first observation of CR, CRu or PR and the date of progressive disease (PD), censored observation or death of any cause. Response duration was also assessed for response defined as CR only. Response duration was calculated among responders (CR+CRu+PR) with cutoffs for follow-up applied.|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population|||percentage of participants|||Number
2657160|NCT01608308|Secondary|Number of Participants Who Received Intraoperative Supplemental Fentanyl|Number of participants who received intraoperative supplemental fentanyl. The decision to administer fentanyl is based on hemodynamic changes, such as increasing blood pressure and heart rate.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)||||participants|||Number
2657129|NCT01609010|Secondary|Percentage of Participants Achieving CR or CRu|CR was defined as the complete disappearance of all previously detectable disease signs; the absence of palpable lymph nodes >1 cm or nodes >1.5 cm observed in CATscan; and negative bone marrow pathology, if initially positive. CRu was defined as CR, except that bone marrow results were indeterminate.|Weeks 10 and 16|ITT population; n=number of participants assessed for the specified parameter at a given visit.|||percentage of participants||95% Confidence Interval|Number
2657130|NCT01609010|Secondary|Percentage of Participants Achieving Complete Response (CR), Unconfirmed CR (CRu), or Partial Response (PR)|CR was defined as the complete disappearance of all previously detectable disease signs; the absence of palpable lymph nodes greater than (>) 1 centimeter (cm) or nodes >1.5 cm observed in computerized axial tomography (CAT) scan; and negative bone marrow pathology, if initially positive. CRu was defined as CR, except that bone marrow results were indeterminate. PR was defined as a decrease of greater than or equal to (≥) 50 percent (%) compared with the BL value in the sum of the products of the two largest perpendicular diameters in all measurable and evaluable lesions; and a ≥50% reduction of the size from BL if hepato-splenomegaly was present.|Weeks 10 and 16|ITT population; number (n) equals (=) number of participants assessed for the specified parameter at a given visit.|||percentage of participants||95% Confidence Interval|Number
2657131|NCT01609010|Primary|Treatment Failure - Time to Event|The median time, in months, between randomization and treatment failure event determined using Kaplan-Meier estimates.|BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population|||months||95% Confidence Interval|Median
2657132|NCT01609010|Primary|Treatment Failure - Percentage of Participants With an Event|Treatment failure was defined as an event of any of the following: progressive disease while receiving study treatment, death due to any cause, or the initiation of another type of treatment due to stable disease, progressive disease or relapse, or intolerance to study treatment.|Baseline (BL), Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period|ITT population|||percentage of participants|||Number
2657133|NCT01608971|Primary|Rotem MCF Fibtem and MCF Intem|The following parameters of the INTEM test will be analyzed: MCF [mm] (maximum clot firmness) which correlates with the platelet count. Furthermore, the MCF [mm] of the FIBTEM test will be analyzed, which correlates with the fibrinogen concentration.|15 Minutes after protamine infusion|Patients of both groups|||mm||Inter-Quartile Range|Median
2657134|NCT01608971|Secondary|12 h Postoperative Blood Loss|The intra and postoperative blood loss from the time point of protamine administration until 12 hours postoperatively will be analyzed.|15 min after protamine administration until 12 hours postoperatively||||ml/12 hour||Inter-Quartile Range|Median
2657135|NCT01608971|Secondary|Transfusion of Blood Products and Coagulation Factors|The transfusion of blood products and coagulation factors will be assesed from protamine administration until 12 hours postoperatively .|From protamine administration until 12 h after surgery|Transfusion of RBC|||percentage of patients transfused|||Number
2657136|NCT01608971|Primary|INTEM HEPTEM and FIBTEM Test of the ROTEM Coagulation Analyzer|The Intem test of the ROTEM analyzer evaluates the response of the heamostatic system to activation of the intrinsic coagulation system. The following parameters of the INTEM test will be analyzed. CT [seconds](coagulation time), CFT [seconds] (clot formation time) and the CT [seconds] of the HEPTEM test which is non sensitive for residual heparine.|Tests will be measured 15 minutes after Protamine infusion|Rotem INTEM CT, CFT, MCF and FIBTEM MCF and Heptem CT|||seconds||Inter-Quartile Range|Median
2657137|NCT01608815|Secondary|Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia. Grade 3 injection site (children): Pain Incapacitating, unable to perform usual activities; Erythema and Swelling ≥ 50 mm; Grade 3 injection site (adults and adolescents): Pain, Significant, prevents daily activity; Erythema and Swelling, >100 mm. Grade 3 systemic reactions: Fever, ≥39˚C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
2657138|NCT01608815|Secondary|Geometric Mean Titer Ratios (GMTRs) of Antibodies to Vi Antibody Following Vaccination With A Typhoid Vi Polysaccharide Vaccine|Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA).|Day 28 post-vaccination|Geometric Mean Titer Ratios were assessed in the Immunology Analysis Set.|||Ratio||95% Confidence Interval|Geometric Mean
2657139|NCT01608815|Secondary|Geometric Mean Titers (GMTs) of Antibodies to Vi Antibody Before and Following Vaccination With A Typhoid Vi Polysaccharide Vaccine|Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA)|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric Mean Titers were assessed in the Immunology Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2657140|NCT01608815|Primary|Number of Participants With At Least a 4-Fold Rise in Vi Antibody Titers Following Vaccination With a Typhoid Vi Polysaccharide Vaccine|Anti Vi antibodies were measured by Enzyme-Linked ImmunoSorbent Assay (ELISA).|Day 0 (pre-vaccination) to Day 28 (post-vaccination)|Vi antibody titers were assessed in the Immunology Analysis Set.|||Participants|||Number
2657141|NCT01608724|Secondary|Change From Baseline in 2-hour Postprandial Plasma Glucose (2h-PPG)||Week 24|Patients who participated in standard noodle test in the per-protocoal analysis set (PPS), which included patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.|||mmol/L||Standard Error|Mean
2657142|NCT01608724|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)||Weeks 6, 12, 18, and 24|Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.|||mmol/L||Standard Error|Mean
2657143|NCT01608724|Secondary|Proportion (%) of Patients Achieving HbA1c <7%||Weeks 6, 12, and 24|Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.|||Percentage|||Number
2657161|NCT01608308|Secondary|Total Doses of Postoperative Opiate (Morphine) Use|The total amount of morphine utilized in Postoperative Acute Care Unit (PACU) will be recorded. One dose is a 1mg bolus of morphine.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)||||doses||Inter-Quartile Range|Median
2657144|NCT01608724|Primary|Absolute Change From Baseline in Haemoglobin A1c (HbA1c)|Evaluation after 24 weeks oral administration of saxagliptin treatment in patients with type 2 diabetes inadequately controlled with diet and exercise or with metformin in addition to diet and exercise.|Weeks 6, 12, and 24|Per-protocoal analysis set (PPS), including patients who took at least 1 dose of study drug, had baseline and post-baseline efficacy records, and had no major protocol deviations.|||(%)||Standard Error|Mean
2657145|NCT01608672|Secondary|Percentage of Participants Where Physician Was Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Physician Questionnaire|"Physicians rated their overall satisfaction with BOTOX® treatment by answering the question on the Physician Reported Overall Satisfaction of Effectiveness Questionnaire: You have treated this patient with BOTOX® facial aesthetic treatment(s) for at least 5 years. How satisfied overall are you with the effect of BOTOX®? using the following possible answers: Very Dissatisfied, Mostly Dissatisfied, Neither Satisfied or Dissatisfied, Mostly Satisfied or Very Satisfied. The percentage of participants where the physician answered Mostly Satisfied or Very Satisfied is reported."|Study Day 1 (approximately 4-28 weeks following last treatment)|Per Protocol population included all enrolled participants who met eligibility criteria with data available for analysis.|||Percentage of participants|||Number
2657146|NCT01608672|Secondary|Percentage of Participants Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Patient Questionnaire|"Participants rated their overall satisfaction with BOTOX® treatment by answering the question on the Patient Reported Overall Satisfaction of Effectiveness Questionnaire: You have received BOTOX® facial aesthetic treatment(s) for at least 5 years. How satisfied overall are you with the effect of BOTOX®? using the following possible answers: Very Dissatisfied, Mostly Dissatisfied, Neither Satisfied or Dissatisfied, Mostly Satisfied or Very Satisfied. The percentage of participants who answered Mostly Satisfied or Very Satisfied is reported."|Study Day 1 (approximately 4-28 weeks following last treatment)|Per Protocol population included all enrolled participants who met eligibility criteria with data available for analysis.|||Percentage of participants|||Number
2657147|NCT01608672|Primary|Percentage of Participants Mostly or Very Satisfied With Their Glabellar Lines on the Facial Line Satisfaction Questionnaire (FLSQ)|"Participants assessed their overall satisfaction with their glabellar lines by answering FLSQ Question 5: How satisfied are you with the effect your treatment had on your facial lines? using a 5-point scale where: -2=very dissatisfied, -1=mostly dissatisfied, 0=neither dissatisfied nor satisfied, 1=mostly satisfied and 2=very satisfied. The percentage of participants mostly or very satisfied is reported."|Study Day 1 (approximately 4-28 weeks following last treatment)|Per Protocol population included all enrolled participants who met eligibility criteria with data available for analysis.|||Percentage of participants|||Number
2657148|NCT01608659|Secondary|Percent of Subjects Reporting Satisfaction With Treatment Effects|Percent of subjects reporting satisfaction with treatment effects per chart notes.|24 Months|All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.|||Percentage of Subjects||Standard Deviation|Mean
2657149|NCT01608659|Secondary|Inter-Injection Interval Duration of Each Treatment Period|Inter-injection interval duration of each treatment period. Duration is defined as the number of days of an injection cycle.|24 Months|All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.|||Days||Full Range|Median
2657150|NCT01608659|Primary|Average Total Dose Per Treatment Period|Average total dose per treatment period was defined as total treatment dose plus total touch-up dose plus total follow-up dose.|24 Months|All subjects enrolled in the study who were evaluated for this data point. N equals the number of subjects evaluated in each treatment period.|||Units||Standard Deviation|Mean
2657151|NCT01608490|Secondary|Mean Percent Change in FEV1|Mean percent change in FEV1 at 12 months|BL to 12 months||||percentage change||Standard Error|Mean
2657152|NCT01608490|Primary|Meters: 6 Minute Walk Test|mean absolute change from baseline at 12 months in the 6 Minute Walk Test comparing test and control groups|baseline through 12 months follow up|Patients who were analyzed at 12 months.|||meters||Standard Error|Mean
2657153|NCT01608321|Primary|Change in the Brief Pain Inventory (Short Form) Score|The Brief Pain Inventory (BPI) is one of the most widely used measurement tools for assessing clinical pain. The BPI allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. The basic pain scale rating is a rating of 0-10 with 0 as no pain, and 10 the worst pain imaginable.|Comparison of baseline BPI and end-of-treatment BPI (time 3-4 weeks)|One patient did not meet study entry criteria at baseline (pain scale score = 0), so was not included in the analysis|||units on a scale||Standard Deviation|Mean
2657154|NCT01608308|Secondary|Postoperative Vital Sign (Respiratory Rate)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)||||breaths per minute||Standard Deviation|Mean
2657155|NCT01608308|Secondary|Postoperative Vital Sign (Temperature)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)||||Fahrenheit||Standard Deviation|Mean
2657156|NCT01608308|Secondary|Postoperative Vital Sign (Pulse)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)||||beats per minute||Standard Deviation|Mean
2657157|NCT01608308|Secondary|Postoperative Vital Sign (Diastolic Blood Pressure)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)||||mmHg||Standard Deviation|Mean
2657158|NCT01608308|Secondary|Postoperative Vital Sign (Systolic Blood Pressure)|Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.|During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)||||mmHg||Standard Deviation|Mean
2657162|NCT01608308|Primary|Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale|VAS is a validated, self-reported data sheet assessing average pain intensity. Possible scores range from 0 (no pain) to 10 (highest level of pain).|15 minutes and 120 minutes Post-Operatively|At the 15 minute time point, data was obtained for 24 participants in the acetaminophen group and 26 participants in the control group. For the 120 minute time point, data was obtained for 7 participants in the acetaminophen group and 11 participants in the control group.|||units on a scale||Inter-Quartile Range|Median
2657163|NCT01608295|Secondary|Changes in Proinflammatory Gene Expression From Baseline to Final Visit (up to 12 Weeks)|Gene expression data were quantile-normalized and log2-transformed in RNA expression units. The measure included the promoter transcription factor binding motif prevalence ratio of the unit (log2 Vilazodone/Paroxetine) and ranging from a minimum of -3 to a maximum of 3 with higher scores indicating better outcomes.|Baseline and Final Visit|The Arms/Groups are not combined, but results are presented as a ratio of Vilazodone/Paroxetine.|||RNA expression units||Standard Error|Mean
2657164|NCT01608295|Secondary|Neurocognitive Measure: The Rey-Osterrieth Complex Figure Test|The The Rey-Osterrieth Complex Figure Test (REY-O) is a neuropsychological assessment in which measures visual perception and long-term visual memory. Total raw scores range from 0 to 36 with higher scores representing better outcomes in recall. The total raw score represents a sum of subscales scored by 18 individual elements which are scored for both distortion and placement. Two points are awarded to elements that are accurately drawn and properly placed, one point is given to distorted or misplaced elements, 0.5 points are given if an element is both distorted and misplaced, and missing or unrecognizable elements receive zero points.|Baseline and Final Visit||||units on a scale||Standard Deviation|Mean
2657165|NCT01608295|Secondary|UKU Side-effect Profile|Number of participants with each side-effect event.|Each visit for 12 weeks||||participants|||Number
2657166|NCT01608295|Primary|Hamilton Depression Rating Scale (HDRS)|The HAMD measures the severity of depressive symptoms in participants with major depressive disorder (MDD). It is a checklist of 17 items that are ranked on a scale of 0-4 or 0-2. The range for the total score (which is the sum of the scores of all 17 items) is 0-52; a higher score indicates greater severity of symptoms.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2657167|NCT01608100|Primary|Clinical Performance- Positive Predictive Value (PPV)|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Positive Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.|||%MI,TnI >cutoff vs all TnI > cutoff||95% Confidence Interval|Number
2657168|NCT01608100|Primary|Clinical Performance- Negative Predictive Value (NPV)|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Negative Predictive Value. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.|||%nonMI,TnI</=cutoff vs all TnI</=cutoff||95% Confidence Interval|Number
2657169|NCT01608100|Primary|Clinical Performance- Specificity|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Specificity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department.|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.|||% nonMI with TnI </= cutoff vs all nonMI||95% Confidence Interval|Number
2657170|NCT01608100|Primary|Clinical Performance- Sensitivity|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating Sensitivity. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.|||percentage MI withTnI >cutoff vs all MI||95% Confidence Interval|Number
2657171|NCT01608100|Secondary|Prognosis|Specimens were collected at 11 EDs from 1,101 subjects presenting to the ED with symptoms consistent with ACS. All subject diagnoses were adjudicated by three board certified cardiologists according to current standard of care. ARCHITECT STAT High Sensitive Troponin I results were generated from subject specimens and evaluated for use as an aid in the assessment of prognosis. Analyses used the first available troponin result from multiple serial draw time points. Subjects were assessed for risk of all cause mortality (ACM) and major adverse cardiac event (MACE) at 30 day and 90 day time points after ED discharge. MACE consisted of myocardial infarction, urgent revascularization, and cardiac death. Subjects were followed-up for subsequent events by medical record review and/or subject/caregiver contact. Any ACM and MACE that occurred during the ED visit and on the same day as ED discharge were not included in the analyses.|30-day and 90-day follow-up|30 Day and 90-day prognosis (Kaplan Meier analysis) and Hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) are summarized. *Censored is defined as the subject has not experienced ACM/MACE at the indicated follow-up time point.|||participants|||Number
2657172|NCT01608100|Primary|Clinical Performance - Area Under the Curve|The ARCHITECT STAT High Sensitive Troponin-I assay clinical performance was evaluated by calculating the Area Under the Curve (AUC). The Area Under the Curve that was assessed, is used to determine the optimum clinical sensitivity and specificity for the ARCHITECT STAT High Sensitive Troponin-I assay. The ARCHITECT STAT High Sensitive Troponin-I assay results were generated from subject's specimens collected at three collection time points in three tube types (K2 EDTA, Lithium Heparin Separator and Serum Separator).|Troponin value from three collection time points (0-2 hours, >2 and up to 4 hours, >4 hours and up to 9 hours) from subject presentation to the emergency department|The number of subjects for analysis was determined by the number of subjects with at least one collection time point in the respective tube type (K2 EDTA, Lithium Heparin Separator, Serum Separator). Not all time points or collection tube types were able to be collected for all subjects.|||Probability||95% Confidence Interval|Number
2657173|NCT01608087|Secondary|Maximum Measured Concentration of the Analyte in Plasma (Cmax)|Maximum measured concentration of the analyte in plasma (Cmax) is presented as adjusted geometric mean (gMean) and geometric coefficient of variation (%) (gCV%). Adjustment was made for treatment effect and weight.|Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion.|Pharmacokinetic (PK) set: The PK set included all subjects in the treated set (subjects who received at least one administration of trial medication) who provided at least one evaluable observation of a PK endpoint and had no important protocol violations relevant to the evaluation of PK biosimilarity.|||microgram/milliliter||Geometric Coefficient of Variation|Geometric Mean
2657174|NCT01608087|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point is presented as adjusted geometric mean (gMean) and geometric coefficient of variation (%) (gCV%). Adjustment was made for treatment effect and weight.|Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion|Pharmacokinetic (PK) set: The PK set included all subjects in the treated set (subjects who received at least one administration of trial medication) who provided at least one evaluable observation of a PK endpoint and had no important protocol violations relevant to the evaluation of PK biosimilarity.|||microgram*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
2657175|NCT01608087|Primary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞).|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented as adjusted geometric mean (gMean) and geometric coefficient of variation (%) (gCV%). Adjustment were made for treatment effect and weight.|Pharmacokinetic samples were collected predose, just before the end of the infusion, 2, 4, and 8 hours after the start of the infusion|Pharmacokinetic (PK) set: The PK set included all subjects in the treated set (subjects who received at least one administration of trial medication) who provided at least one evaluable observation of a PK endpoint and had no important protocol violations relevant to the evaluation of PK biosimilarity.|||microgram*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
2657176|NCT01607957|Secondary|Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs were events between administration of study drug and up to 30 Days that were absent before treatment or that worsened relative to pre-treatment state. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability /incapacity; congenital anomaly. The AEs were graded for severity using National Cancer Institute Common Terminology Criteria for AEs.|From the time of signing the informed consent form until the period of participant follow up (30 days following after the administration of last dose of study medication or until initiation of new antitumor therapy, whichever was earlier|Safety analysis was performed on as treated (AT) population including all participants who took part of any dose of the study medication.|||percentage of participants|||Number
2657177|NCT01607957|Secondary|Progression-free Survival|Tumor assessments were performed throughout the study based on RECIST, Version 1.1, 2009. Progression free survival was defined as the time (in months) from the date of randomization until the date of the investigator-assessed radiological disease progression or death due to any cause. For participants who were alive with no radiological disease progression as of the analysis cut-off date, their survival was censored at the date of the last tumor assessment. Participants who received non-study cancer treatment before disease progression, or participants with clinical but not radiologic evidence of progression, were censored at the date of the last radiologic evaluable tumor assessment before the non-study cancer treatment was initiated.|Every 8 weeks, up to 12 months after the last participant was randomized or until the date of the investigator-assessed radiological disease progression or death due to any cause,whichever was later. (Progression free survival cutoff: 31 Jan 2014)|Analysis was performed in ITT population.|||months||95% Confidence Interval|Median
2657178|NCT01607957|Primary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death for participants. If a participant discontinued study medication for reasons other than radiologic disease progression, the participant was followed for tumor response until radiologic disease progression or initiation of new anticancer therapy.|Every 8 weeks, up to 12 months after the last participant was randomized or until the target number of events (deaths) was met, whichever was later. (Overall survival data was collected till 24 Jan 2014 which was date of observation of the 571st death)|Analysis was performed in ITT population. For participants who were alive as of the overall survival cutoff date, their survival was censored on the cutoff date post consent.|||months||95% Confidence Interval|Median
2657179|NCT01607853|Secondary|Change in Skin Thickness - Echo-poor Band - Measured by Ultrasound From Baseline to Day 22||Baseline to day 22||||millimeters||Standard Deviation|Mean
2657180|NCT01607853|Secondary|Change in Lesion Thickness Measured by Ultrasound From Baseline to Day 22.||Baseline to day 22||||millimeters||Standard Deviation|Mean
2657236|NCT01607450|Secondary|Myocardial Total Oxidation Rate|MVO2 derived from acetate kinetics|After 12 hours of GLP-1 exposure||||ml/min/100g||Standard Deviation|Mean
2657199|NCT01607853|Secondary|Change in Total Clinical Score at Day 18 Compared to Baseline|Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.|Baseline to day 18||||units on a scale||Standard Deviation|Mean
2657200|NCT01607853|Secondary|Change in Total Clinical Score at Day 15 Compared to Baseline|Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinial Score.|Baseline to day 15||||units on a scale||Standard Deviation|Mean
2657201|NCT01607853|Secondary|Change in Total Clinical Score at Day 11 Compared to Baseline|Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.|Baseline to day 11||||units on a scale||Standard Deviation|Mean
2657202|NCT01607853|Secondary|Change in Total Clinical Score at Day 8 Compared to Baseline|Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.|Baseline to day 8||||units on a scale||Standard Deviation|Mean
2657203|NCT01607853|Secondary|Change in Total Clinical Score at Day 4 Compared to Baseline|Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score.|Baseline to day 4||||units on a scale||Standard Deviation|Mean
2657204|NCT01607853|Primary|Change in Total Clinical Score From Baseline to Day 22|Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clincal Score|baseline to day 22||||units on a scale||Standard Deviation|Mean
2657205|NCT01607658|Secondary|Change in Global Sexual Functioning From Day 0 to Day 84|as measured by Female Sexual Function Index (FSFI) on Day 0 and 84, respectively. The FSFI, a 19-item questionnaire, has been developed as a brief, multidimensional self-report instrument for assessing the key dimensions of sexual frustration in women. The questionnaire provides scores on 6 domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain) as well as a total score. Fifteen items are rated on a 6-point Likert scale (from 0 to 5) and 4 items on a 5-point Likert scale (from 1 to 5). The scores are added and converted using a conversion factor so that the maximum score for each domain is 6. The overall FSFI score can range from 2 to 36. Higher scores indicate better or higher sexual function.|Day 0 and Day 84|The number of participants analyzed is equal to the number of participants who completed the Day 84 visit.|||units on a scale||Standard Deviation|Mean
2657206|NCT01607658|Secondary|Change in Distress Due to Female Orgasmic Disorder From Day 0 Baseline to Day 84|as measured by Female Sexual Distress Scale (FSDS-DAO) Question #15 on Day 0 and 84, respectively. Question #15 evaluates the level of distress related to problems with orgasm. It is rated on a 5-point Likert scale (from 0 to 4, i.e. never [0], rarely [1], occasionally [2], frequently [3], or always [4]). Higher scores indicate more distress.|Day 0 and Day 84|The number of participants analyzed is equal to the number of participants who completed the Day 84 visit.|||units on a scale||Standard Deviation|Mean
2657207|NCT01607658|Secondary|Change in Sexual Event Satisfaction Over a 28-day Period (Day 57 to Day 84) Compared to Baseline (Day -28 to Day 0)|"as measured by Monash Women's Health Program Female Sexual Satisfaction Questionnaire (MONASH WHP FSSQ) question 11.~MONASH WHP FSSQ question 11 asks participants to comment on how satisfying they found the sex to be from Not at all to Very much so. The lowest score is 1 and the highest is 9. All scores for each 28-day period were averaged. Change from baseline was obtained by subtracting baseline 28-day average from the 28-day period at the end of the study (Day 57 to 84)."|Baseline (Day -28 to Day 0) and End of Study (Day 57 to 84)|The number of participants analyzed is equal to the number of participants who completed the Day 84 visit.|||units on a scale||Standard Deviation|Mean
2657208|NCT01607658|Primary|Number of Orgasms Over an 84 Day Period Compared to Placebo Over the Entire Treatment Period||84 days|ITT Population|||orgasms||Standard Deviation|Mean
2657209|NCT01607645|Secondary|Duration of Thrombocytopenia Defined as Platelet Count Less Than 100,000||Assessed for up to 5 years|No member of Arm II was eligible for evaluation for this Outcome Measure. Therefore, no data was collected for Arm II.|||days||Full Range|Mean
2657210|NCT01607645|Secondary|Duration of Moderate Neutropenia Defined as an ANC Less Than 1000||Assessed for up to 5 years|No member of Arm II was eligible for evaluation for this Outcome Measure. Therefore, no data was collected for Arm II.|||days||Full Range|Mean
2657211|NCT01607645|Secondary|Duration of Severe Neutropenia Defined as an ANC Less Than 500||Assessed for up to 5 years|No member of Arm II was eligible for evaluation for this Outcome Measure. Therefore, no data was collected for Arm II.|||days||Full Range|Mean
2657212|NCT01607645|Secondary|Severe Prolonged Aplasia||Assessed for up to 45 days||||Participants|||Count of Participants
2657213|NCT01607645|Secondary|Frequency and Severity of Grade 3, 4, and 5 Toxicities With Each Course of Decitabine-priming, Idarubicin, and Cytarabine According to NCI Common Terminology Criteria for Adverse Events Version (CTCAE) 4.0||Assessed for up to 3 months after completion study treatment|We have analyzed 4 and 3 patients in each arm, respectively. One patient in each of the arms completed 2 cycles of therapy. The numbers provided in the Outcome Measure Data Table in Frequency and Severity of Grade 3, 4, and 5 Toxicities are the numbers of patients with each specified event.|||Participants|||Count of Participants
2657214|NCT01607645|Secondary|TRM With Each Course of Decitabine-priming, Idarubicin, and Cytarabine||Assessed for up to Day 30||||Participants|||Count of Participants
2657215|NCT01607645|Secondary|CRiMRD+ Defined as Meeting All Criteria for a CRi But With Evidence of Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers||Assessed for up to 5 years||||Participants|||Count of Participants
2657216|NCT01607645|Secondary|CRMRD+ Defined as a Morphologic CR But With Minimal Residual Disease by Flow Cytometry, Cytogenetics, or Other Known Molecular Biomarkers||Assessed for up to 5 years||||Participants|||Count of Participants
2657221|NCT01607645|Primary|Number of Participants Who Achieved Morphologic CR|Morphologic complete remission (CR): Absolute Neutrophil Count (ANC)≥1,000/uL, platelet count ≥100,000/uL, <5% Bone Marrow (BM) blasts, no Auer rods (cytoplasmic inclusions which result from an abnormal fusion of the primary (azurophilic) granules), no morphologic dysplasia, and no evidence of extramedullary disease|Participants were monitored up until the point when they went off study following completion of the treatment (3 months)||||participants|||Number
2657222|NCT01607593|Primary|Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation|Number of participants in each category of CGI-S at start and end of administration/observation. CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.|Up to 6 years|FAS was defined as those who had a record of either CGI-I or CGI-S.|||Participants|||Number
2657223|NCT01607593|Primary|Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation|Number of participants in each category of CGI-S at start and end of administration/observation. CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.|Start of administration|FAS was defined as those who had a record of either CGI-I or CGI-S.|||Participants|||Number
2657224|NCT01607593|Primary|Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation|Number of participants in each category of CGI-I at end of administration/observation. CGI-I is a 7-point clinician-rated scale, ranging from (1) Very much improved, (2)Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, and (7) Very much worse.|Up to 6 years|Full analysis set (FAS) was defined as those who had a record of either CGI-I or Clinical Global Impression of Severity (CGI-S).|||Participants|||Number
2657225|NCT01607554|Secondary|Median Overall Survival (OS)||100 months|No data were collected for this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.||||||
2657226|NCT01607554|Secondary|Median Duration of Response||Up to 100 months|No data were collected for this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.||||||
2657227|NCT01607554|Secondary|Progression Free Survival (PFS)||Up to 100 months|No data were collected for this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.||||||
2657228|NCT01607554|Secondary|Toxicity of Irinotecan Salvage Chemotherapy|Use blood samples to measure possible 1) Neutropenia, 2) Thrombocytopenia, 3)Diarrhea; 4) Other measures of toxicity other than alopecia, anorexia, and asthenia as listed in the National Cancer Institute Common Toxicity Criteria v. 4.03|2 days preceding each cycle of therapy|There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.||||||
2657229|NCT01607554|Secondary|Retrospectively Evaluate the Role of Tumor SULF2 Gene Methylation Status in Treatment Efficacy|Patients who have a loss of SULF2 gene expression have a better outcome than those whose tumors express SULF2. High level of ISG15 expression in NSCLC may indicate a subgroup of tumors that may be more sensitive to the cytotoxic effects of irinotecan. In patients who consent to screening, 10 unstained slides of archived diagnostic tissue will be obtained from formalin-fixed, paraffin-embedded specimens and analyzed in the laboratories of our Lovelace Respiratory Research Institute co-investigators.|1 year|No data was collected for this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.||||||
2657230|NCT01607554|Secondary|Time to Progression (TTP)|Time to progression will be measured from the time of first treatment until there is evidence of progressive disease or death, from the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 100 months. Death will be treated as a progression event.|Up to 100 months|No data were collected on this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.||||||
2657231|NCT01607554|Primary|Tumor Response|Change in tumor size will be measured by CT scan using RECIST criteria.|8 weeks|Both participants experienced an increase in tumor size between the time of the baseline CT scan and the first study CT scan. There will be no publication or further data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution.|||Participants|||Count of Participants
2657232|NCT01607476|Primary|Global Distribution of F18 Flutemetamol in the Brain|"The imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts.~The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from two different regions within the same PET image. For the SUVR, the injected activity, the body weight and the volume to mass conversion factor that are all part of the SUV calculation, cancel."|Approximately one hour after injection of positron emission tomography (PET) drug||||standard uptake value ratio||Standard Deviation|Mean
2657233|NCT01607476|Primary|Global Distribution of C11 PiB in the Brain|"The imaging analysts use a global atlas of the brain to measure the uptake of the radioactive tracer (or brightness) globally. This global uptake was normalized to the uptake in the cerebellar crus region of the brain to get a global Standard Uptake Value Ratio (SUVR). The cerebral crus (crus cerebri) is the anterior portion of the cerebral peduncle which contains the motor tracts.~The standard uptake value (SUV) is a way of determining activity in PET imaging. The SUVR is the ratio of SUV from two different regions within the same PET image. For the SUVR, the injected activity, the body weight and the volume to mass conversion factor that are all part of the SUV calculation, cancel."|Approximately one hour after injection of positron emission tomography (PET) drug||||standard uptake value ratio||Standard Deviation|Mean
2657239|NCT01607411|Secondary|Enamel Fluoride Uptake|Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on amount of F divided by volume of the enamel cores and expressed as micrograms (μg)* F/centimeters(cm)^2. Difference between treatments was calculated with respect to F uptake by enamel.|Baseline to 4 hours|Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens|||μg*F/cm^2||Standard Error|Mean
2657240|NCT01607411|Secondary|Percent Net Acid Resistance (%NAR) of Enamel Specimens|Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NAR which compared the indentations values of sound enamel specimens at baseline (B), first demineralization challenge (D1) and second demineralization challenge (D2). Percent NAR was calculated by formula: [(D1-D2)/ (D1-B)]*100.|Baseline to 4 hours|Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens.|||%NAR||Standard Error|Mean
2657241|NCT01607411|Secondary|%SMHR of Enamel Specimens Exposed to Test Treatments|Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100.|Baseline to 4 hours|Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens.|||%SMHR||Standard Error|Mean
2657242|NCT01607411|Primary|Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice|Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100.|Baseline to 4 hours|Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens.|||%SMHR||Standard Error|Mean
2657243|NCT01607398|Secondary|Number of Participants Who Experienced the Indicated Number of COPD Exacerbations During the Treatment Period|The occurrence of a COPD exacerbation was assessed on each day of evaluation during the treatment period per the defined severity classifications. COPD exacerbations were classified based on severity as a mild exacerbation (exacerbation of COPD symptoms were manageable by the participant, not requiring systemic corticosteroid or antimicrobial therapy), a moderate exacerbation (exacerbation of COPD symptoms required systemic corticosteroid or antimicrobial therapy), or a severe exacerbation (exacerbation of COPD symptoms required hospitalization). The number of participants who experienced 0, 1, 2, and >=3 exacerbation(s) was summarized.|From Baseline up to Week 12|Per Protocol Population|||Participants|||Number
2657244|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Total Score at Week 12|Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8; each question scored from 0 to 5) designed to assess the health status of participants with COPD. The total score is calculated as the sum of the scores from Questions 1 to 8, for a range of possible scores of 0 to 40. A higher total score represents a lower quality of life, and vice versa. Change from Baseline was calculated as the Week 12 score minus the Baseline score.|Baseline and Week 12|Per Protocol Population|||Scores on a scale||Standard Deviation|Mean
2657245|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 8 Score at Week 12|"Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 8, participants were asked to rate how much energy they have on a scale of 0 to 5: 0, I have lots of energy; 5, I have no energy at all. Change from Baseline was calculated as the Week 12 score minus the Baseline score."|Baseline and Week 12|Per Protocol Population|||Scores on a scale||Standard Deviation|Mean
2657246|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 7 Score at Week 12|"Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 7, participants were asked to rate how soundly they sleep on a scale of 0 to 5: 0, I sleep soundly; 5, I don't sleep soundly because of my lung condition. Change from Baseline was calculated as the Week 12 score minus the Baseline score."|Baseline and Week 12|Per Protocol Population|||Scores on a scale||Standard Deviation|Mean
2657247|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 6 Score at Week 12|"Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 6, participants were asked to rate how confident they are leaving home despite their lung condition on a scale of 0 to 5: 0, I am confident leaving my home despite my lung condition; 5, I am not at all confident leaving my home because of my lung condition. Change from Baseline was calculated as the Week 12 score minus the Baseline score."|Baseline and Week 12|Per Protocol Population|||Scores on a scale||Standard Deviation|Mean
2657248|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 5 Score at Week 12|"Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 5, participants were asked to rate how limited they are in doing activities at home on a scale of 0 to 5: 0, I am not limited doing any activities at home; 5, I am very limited doing activities at home. Change from Baseline was calculated as the Week 12 score minus the Baseline score."|Baseline and Week 12|Per Protocol Population|||Scores on a scale||Standard Deviation|Mean
2657249|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 4 Score at Week 12|"Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 4, participants were asked to rate how breathless they feel when walking up a flight of stairs or a hill on a scale of 0 to 5: 0, When I walk up a hill or one flight of stairs I am not breathless; 5, When I walk up a hill or one flight of stairs I am very breathless. Change from Baseline was calculated as the Week 12 score minus the Baseline score."|Baseline and Week 12|Per Protocol Population|||Scores on a scale||Standard Deviation|Mean
2657250|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 3 Score at Week 12|"Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 3, participants were asked to rate how tight their chest feels on a scale of 0 to 5: 0, My chest does not feel tight at all; 5, My chest feels very tight. Change from Baseline was calculated as the Week 12 score minus the Baseline score."|Baseline and Week 12|Per Protocol Population|||Scores on a scale||Standard Deviation|Mean
2657251|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 2 Score at Week 12|"Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 2, participants were asked to rate the amount of phlegm (mucus) in their chest on a scale of 0 to 5: 0, I have no phlegm (mucus) in my chest at all; 5, My chest is completely full of phlegm (mucus). Change from Baseline was calculated as the Week 12 score minus the Baseline score."|Baseline and Week 12|Per Protocol Population|||Scores on a scale||Standard Deviation|Mean
2657252|NCT01607398|Secondary|Change From Baseline in the COPD Assessment Test (CAT) Question 1 Score at Week 12|"Participants completed the CAT questionnaire before undergoing respiratory function tests at Baseline and at Week 12. The CAT questionnaire is an 8-item questionnaire (comprised of Question [Q] 1 to Q8) designed to assess the health status of participants with COPD. In Question 1, participants were asked to rate how much they cough on a scale of 0 to 5: 0, I never cough; 5, I cough all the time. Change from Baseline was calculated as the Week 12 score minus the Baseline score."|Baseline and Week 12|Per Protocol Population|||Scores on a scale||Standard Deviation|Mean
2657253|NCT01607398|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Week 12|FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Respiratory function tests were performed for the measurement of FEV1 and FVC at Baseline and at Week 12. The values were measured at 15 to 60 minutes following the use of a pressurized metered-dose inhaler. Three technically acceptable values were obtained, and the highest value was recorded. Change from Baseline in FEV1 and FVC was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population|||Liters (L)||Inter-Quartile Range|Median
2657254|NCT01607398|Secondary|Change From Baseline in Fibrinogen Levels in Serum at Week 12|Per Protocol Amendment 4, the measurement of fibrinogen levels in serum was removed from the analysis plan because fibrinogen levels were found to be too low and too difficult to measure.|Baseline and Week 12|||||||
2657255|NCT01607398|Secondary|Change From Baseline in hsCRP, SP-D, and Clara Cell Protein 16 (CC 16) Levels in Serum at Week 12|Serum samples were collected at Baseline and at Week 12. The levels of hsCRP, SP-D, and CC16 in serum samples were measured at the same time using the multiplex assay system. Change from Baseline in hsCRP, SP-D, and CC16 was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population|||ng/mL||Inter-Quartile Range|Median
2657256|NCT01607398|Secondary|Change From Baseline in IL-6 and IL-8 Levels in Serum at Week 12|Serum samples were collected at Baseline and at Week 12. The levels of IL-6 and IL-8 in serum samples were measured at the same time using the multiplex assay system. Change from Baseline in IL-6 and IL-8 levels was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population|||pg/mL||Inter-Quartile Range|Median
2657257|NCT01607398|Secondary|Change From Baseline in Myeloperoxidase (MPO) and Pulmonary Surfactant Protein (SP)-D Levels in Sputum Supernatant at Week 12|Induced sputum samples were collected at Baseline and at Week 12. The levels of MPO and SP-D in the supernatant of an induced sputum sample were measured at the same time using the multiplex assay system. Change from Baseline in MPO and SP-D levels was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population. Only those participants available at the specified time points were analyzed.|||ng/mL||Inter-Quartile Range|Median
2657258|NCT01607398|Secondary|Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) Levels in Sputum Supernatant at Week 12|Data cannot be reported because hsCRP was under the lower limit of detection in all samples.|Baseline and Week 12|||||||
2657259|NCT01607398|Secondary|Change From Baseline in Interleukin (IL)-8 Levels in Sputum Supernatant at Week 12|Induced sputum samples were collected at Baseline and at Week 12. The levels of IL-8 in the supernatant of an induced sputum sample were measured at the same time using the multiplex assay system. Change from Baseline in IL-8 levels was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population. Only those participants available at the specified time points were analyzed.|||Picograms per milliliter (pg/mL)||Inter-Quartile Range|Median
2657260|NCT01607398|Secondary|Change From Baseline in Interferon (INF)-Gamma-positive Cells and Perforin-positive Cells in Sputum at Week 12|"INF-gamma-positive cells and perforin-positive cells were not detected in samples collected in this study due to the conditions of the samples and/or antibodies. No re-assays were performed, no result/no data was entered into the case report forms, and no statistical analysis or data summarization was performed."|Baseline and Week 12|||||||
2657261|NCT01607398|Secondary|Change From Baseline in All Inflammatory Cell Count in Induced Sputum at Week 12|Induced sputum samples were collected at Baseline and at Week 12. All inflammatory cells in induced sputum were counted with the use of a cytological specimen of cells in the induced sputum. Change from Baseline in all inflammatory cell count was calculated as the Week 12 value minus the Baseline value.|Baseline and Week 12|Per Protocol Population. Only those participants available at the specified time points were analyzed.|||Cells per millimeters cubed (cells/mm^3)||Inter-Quartile Range|Median
2657262|NCT01607398|Primary|Change From Baseline in Neutrophil Count in Induced Sputum at Week 12|Induced sputum samples were collected at Baseline and at Week 12. The neutrophil count in induced sputum was measured with the use of a cytological specimen of inflammatory cells in the induced sputum. Change from Baseline in neutrophil count was calculated as the Week 12 value minus the Baseline value (percentage of neutrophil of total cells in induced sputum at Week 12 minus the Baseline value).|Baseline and Week 12|Per Protocol Population: all participants who had an evaluable sputum sample at Baseline and at the endpoint of interest, were randomized to study treatment and received at least one dose of study medication, and had no major protocol violations. Only those participants available at the specified time points were analyzed.|||ratio (%)||Inter-Quartile Range|Median
2657263|NCT01607346|Secondary|Change From Baseline in PVR Volume by Bladder Ultrasound at Visits 3, 4, 5 and 6|PVR is the the amount of urine left in the bladder after urination. Bladder ultrasound was performed to assess PVR at Baseline/Visit 2 (Day -1), Visit 3 (Day 21), Visit 4 (Day 35), Visit 5 (Day 49) and Visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Up to Day 80 (Visit 6)|Safety Population|||mL||Standard Deviation|Mean
2657264|NCT01607346|Secondary|Cystometry Assessment at Visits 3, 4, 5 and 6|Cystometry is a test of bladder function in which pressure and volume of fluid in the bladder is measured during filling, storage, and voiding. Cystometry was assessed at Baseline visit 2 (Day -1) and on visit 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). The requirement for cystometry was discovered by the study monitor and discussed with the GSK medical monitor after the participants had completed the study.|Up to Day 80 (Visit 6)|Data were not collected, although 3 participants met at least 1 of the criteria for multichannel cystometry during the study, the assessment was not performed.||||||
2657265|NCT01607346|Secondary|Change From Baseline in American Urological Association Symptom Index (AUA SI) at Visits 3, 4, 5 and 6|The America Urological Association Symptom Index is a 7-item Likert-scored scale describing urinary bladder function. It is the sum of the responses to the 7 AUA symptom questions. Score ranges from 0 to 5 (0=not at all and 5=almost always for questions 1 to 6; 0=None and 5=five times or more for question 7). The total score ranges from 0-35 where higher scores indicate more severe symptoms. It was completed by the investigator at Baseline visit 2 (Day -1) and on visit 3 (Day 21), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||Scores on a scale||Standard Deviation|Mean
2657266|NCT01607346|Secondary|Volume Voided as Recorded on the Voiding Diary for 2 Days Prior to Each Post-baseline Visit|The participants were asked to complete a voiding diary for two days preceding each visit. Volume voided for 2 days prior to each visit was defined as sum of urine recorded within 2 days prior to each post-baseline visit. Voiding diary was assessed at Baseline visit 2 (Day -1) and on visit 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||mL||Standard Deviation|Mean
2657267|NCT01607346|Secondary|Frequency of Micturition as Recorded on the Voiding Diary for 2 Days Prior to Each Visit|The participants were asked to complete a voiding diary for two days preceding each visit. Frequency of micturition for 2 days prior to dach visit was defined as total number of entries recorded within 2 days prior to each post-baseline visit. Voiding diary was assessed at Baseline visit 2 (Day -1) and on visit 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||Micturition voided||Standard Deviation|Mean
2657268|NCT01607346|Secondary|Change From Baseline in Average Flow Rate (Qmean) at Visits 3, 4, 5 and 6|Average flow rate was measured by uroflowmetry test. It is a non-invasive diagnostic test that measures the speed of urinary flow. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visit 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||mL per second||Standard Deviation|Mean
2657294|NCT01607112|Primary|Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|A seroconverted subjects was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2657269|NCT01607346|Secondary|Change From Baseline in Flow Time at Visits 3, 4, 5 and 6|Flow time was measured by uroflowmetry test. It is a non-invasive diagnostic test that measures the speed of urinary flow. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visit 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||Seconds||Standard Deviation|Mean
2657270|NCT01607346|Secondary|Change From Baseline in Time to Maximum Flow at Visits 3, 4, 5 and 6|Time to maximum flow was measured by uroflowmetry test. It is a non-invasive diagnostic test that measures the speed of urinary flow. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visits 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||Seconds||Standard Deviation|Mean
2657271|NCT01607346|Secondary|Change From Baseline in Voided Volume (VV) at Visits 3, 4, 5 and 6|The volume of urine voided was measured by uroflowmetry test. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visits 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||mL||Standard Deviation|Mean
2657272|NCT01607346|Secondary|Change From Baseline in Percentage Residual Urinary Volume (RUV) at Visits 3, 4, 5 and 6|Percentage residual urinary volume is a standardized measure of post-residual volume and is defined as residual devided by residual plus voided multiplied by 100 where 'residual' is the post-void residual (PVR) volume collected on the bladder ultrasound and 'voided' is the voided volume collected on the uroflowmetry. Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated as post-baseline minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||Percentage of residual urinary volume||Standard Deviation|Mean
2657273|NCT01607346|Secondary|Percent Change From Baseline in Qmax at Visits 3, 4, 5 and 6|Maximum urine flow rate was measured by uroflowmetry test. It is a non-invasive diagnostic test that measures the speed of urinary flow. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visits 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. The percentage change from Baseline was calculated as post-baseline value minus Baseline value divided by Baseline value multiplied by 100. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||Percent change||Standard Deviation|Mean
2657274|NCT01607346|Secondary|Change From Baseline in Maximum Flow Rate (Qmax) at Visits 3, 4 and 6|Maximum urine flow rate was measured by uroflowmetry test. It is a non-invasive diagnostic test that measures the speed of urinary flow. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visits 3 (Day 21), visit 4 (Day 35), visit 5 (Day 49) and visit 6 (follow-up visit within 14 days after the end-of-treatment eye examination). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline (Day -1) and up to Day 80 (Visit 6)|Safety Population|||mL per second||Standard Deviation|Mean
2657275|NCT01607346|Primary|Change From Baseline in Maximum Flow Rate (Qmax) at Visit 5.|Maximum urine flow rate was measured by uroflowmetry test. It is a non-invasive diagnostic test that measures the speed of urinary flow. Uroflowmetry was assessed at Baseline visit 2 (Day -1) and on visits 3, 4 and 5 (Days 21, 35 and 49 respectively). Measurement at visit 2 (Day -1) was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value at Visit 5. Safety Population was defined as all participants who received more than or equal to one dose of study medication.|Baseline (Day -1) and on Day 49 (Visit 5)|Safety Population|||Milliliter (mL) per second||Standard Deviation|Mean
2657276|NCT01607320|Secondary|Ovulation|If ovulation does not occur during the first treatment cycle, subject will be withdrawn from study.|Cycle day 22-24|Data collected could not be analyzed as it was never unblended and randomization is unknown.||||||
2657277|NCT01607320|Primary|Pregnancy|Time frame will vary depending on how many treatment cycles it takes to get pregnant. If no pregnancy occurs, study participation will likely be about 4 months.|4 months|The study was randomized between the two treatments and was never unblinded, therefore randomization is unknown and data collection is incomplete.||||||
2657278|NCT01607255|Primary|Number of Participants With Detected Proximal Diminutive (<10 mm) Adenoma Detection Rate|Proximal diminutive adenoma detection rate (ADR) in screening colonoscopy performed with the unusual air method, versus the water (exchange) method and with dye added to the water (exchange) method|36 months||||participants|||Number
2657279|NCT01607203|Secondary|Patients With Cryopreserved Embryos||4 weeks||||patients with cryopreserved embryos|||Number
2657280|NCT01607203|Secondary|Pregnancy Rate|the number of pregnancies obtained, wich still is the most important issue for the patients|12 weeks||||pregnancies|||Number
2657281|NCT01607203|Primary|MII Oocytes|the number of mature oocytes retrieved|3 weeks||||cumulus oocyte complex||Standard Deviation|Mean
2657306|NCT01606748|Primary|PK: Dose Normalized AUC(0-∞) of Gemcitabine||Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2657282|NCT01607112|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Days 0-21)|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
2657283|NCT01607112|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 21-day follow-up period (Days 0-20) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
2657284|NCT01607112|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|"Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain.~Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C"|During the 4-day follow-up period (Day 0-3) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Subjects|||Number
2657285|NCT01607112|Secondary|Duration of Solicited General Symptoms.|Duration was defined as number of days with any grade of general symptoms.|During the 4-day follow-up period (Days 0-3) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Days||Full Range|Median
2657286|NCT01607112|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.|During the 4-day (Day 0-Day 3) follow-up period after vaccination|Analysis was performed on the Total Vaccinated cohort which included all subjects with vaccine administration documented.|||Subjects|||Number
2657287|NCT01607112|Secondary|Duration of Solicited Local Symptoms.|Duration was defined as number of days with any grade of local symptoms.|During the 4-day follow-up period (Days 0-3) after vaccination|Analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.|||Days||Full Range|Median
2657288|NCT01607112|Secondary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. This outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2657289|NCT01607112|Secondary|Number of Subjects Who Seroconverted for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|SCR was defined as the number of vaccinees with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer. The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2657290|NCT01607112|Secondary|Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|Seroprotection rate SPR was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40. The outcome measure was assessed by the influenza vaccination status in the 2011-2012 season, in subjects aged > 60 years.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2657291|NCT01607112|Secondary|Humoral Immune Response in Terms of Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included H1N1, H3N2 and Yamagata antigens. The outcome measure was assessed by influenza vaccination status in the 2011-2012 season, in subjects aged greater than (>) 60 years.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titer||95% Confidence Interval|Geometric Mean
2657292|NCT01607112|Primary|Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value.|SPP was defined as the number of vaccinees with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2657293|NCT01607112|Primary|Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.|MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0.|At Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Fold increase||95% Confidence Interval|Geometric Mean
2657295|NCT01607112|Primary|Number of Subjects Who Were Seroprotected for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.|Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer greater than or equal to (≥) 1:40.|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Subjects|||Number
2657296|NCT01607112|Primary|Humoral Immune Response in Terms of Haemagglutination (HA) Antibody Titers Against Each of the Three Vaccine Influenza Strains|Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/10 (H1N1), Flu A/Victoria/361/11 (H3N2) and Flu B/Hubei-Wujiagang/158/09 (Yamagata).|At Day 0 and Day 21|Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Titer||95% Confidence Interval|Geometric Mean
2657297|NCT01606852|Secondary|Number of Participants With Adverse Events|arterial hypotension, bradycardia, self-extubations, and protocol violations related to drug, pump or both.|During 5 days of study protocol||||participants|||Number
2657298|NCT01606852|Primary|Aggregate Sedative Exposure During PCS Use (up to 5 Days).|Will use the sedation intensity score Scale is based on a score of 1 (full arousal) to 4 (no arousal)|5 days after enrollment||||units on a scale||95% Confidence Interval|Number
2657299|NCT01606800|Primary|Number of Participants Achieving Sustained Virologic Response (SVR)|SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.|At 24 weeks after the completion of therapy (up to 72 weeks)|All Treated Population, which included all participants who received at least one dose of study medication after RVR.|||Participants|||Number
2657300|NCT01606787|Secondary|Percent Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to 6 Weeks|between treatment groups at 6 weeks (+/- 4 weeks) after surgery with postoperative eGFR as the outcome, and treatment group, surgical technique, and preoperative eGFR as covariates. We will also use the ANCOVA on the absolute level of eGFR because this has the greatest statistical power. However, the estimate produced by ANCOVA - a mean difference in eGFR levels - is of incomplete clinical interpretability.|6 weeks||||% change from preoperative eGFR||Standard Deviation|Mean
2657301|NCT01606787|Primary|Percent Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline to 6 Months|The difference will be assessed with an ANCOVA model with eGFR 6 months after surgery (+/- 2 months) as the outcome and treatment group, surgical technique, and preoperative eGFR as covariates. We will report a two-tailed p-value and a 95% confidence interval for the difference between groups. If a patient does not have an eGFR measurement between 5-7 months after surgery and has both a measurement between 3-5 months and 7-12 months after surgery, then the 6 month eGFR measurement will be linearly interpolated.|6 months||||% change from preoperative eGFR||Standard Deviation|Mean
2657302|NCT01606761|Secondary|Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission at Week 24|The Disease Activity Index Score 28 (DAS28) based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (<) 2.6 at any study visit.|Week 24|Efficacy full analysis set included all participants who were randomized into the study.|||Percentage of Participants|||Number
2657303|NCT01606761|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response at Week 24|The ACR 50 Response is defined as >= 50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS ( 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 =no pain to 10 =worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).|Week 24|Efficacy full analysis set included all participants who were randomized into the study.|||Percentage of Participants|||Number
2657304|NCT01606761|Secondary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24|The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline and Week 24|Efficacy full analysis set included all participants who were randomized into the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this endpoint.|||Units on a scale||Standard Deviation|Mean
2657305|NCT01606761|Primary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16|The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 =no pain to 10 =worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).|Week 16|Efficacy full analysis set included all participants who were randomized into the study.|||Percentage of Participants|||Number
2657476|NCT01605825|Other Pre-specified|Assistance Required to Perform Activities of Daily Living (ADL) by the Functional Independence Measure (FIM) Scale||Days 1, 8, 15, 22, 29, and 36|||||||
2657307|NCT01606748|Primary|PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity, (AUC[0-∞]) of Necitumumab||Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion; Cycle 1 Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK.|||ug*h/mL||Geometric Coefficient of Variation|Geometric Mean
2657308|NCT01606748|Primary|PK: Dose-Normalized AUC(0-5) of Cisplatin||Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2657309|NCT01606748|Secondary|PK: AUC(0-∞) of Necitumumab After Administration of Process C and Process D Drug Product||Run-In Period Day 3 Cohort 1 and Cohort 2: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK.|||ug*h/mL||Geometric Coefficient of Variation|Geometric Mean
2657310|NCT01606748|Primary|PK: Dose-Normalized AUC(0-24) of Gemcitabine||Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.|||ng*h/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2657311|NCT01606748|Secondary|PK: Cmax of Necitumumab After Administration of Process C and Process D Drug Product||Run-In Period Day 3 Cohort 1 and Cohort 2: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK.|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2657312|NCT01606748|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR]) (Antitumor Activity of Necitumumab in Combination With Gemcitabine-cisplatin Chemotherapy)|ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) * 100.|Baseline to Measured Progressive Disease (Up to 14 Months)|All participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2657313|NCT01606748|Secondary|Number of Participants With Anti-Necitumumab Antibodies|A participant was considered to have an anti-necitumumab antibody response if anti-drug antibodies (ADA) were confirmed positive. Treatment emergent antibodies were defined as any anti-necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.|Baseline through, 30-Day Follow-Up|All participants who received at least one dose of study drug and had evaluable baseline and postbaseline data for antibodies.|||participants with immunogenicity samples|||Number
2657314|NCT01606748|Primary|PK: Area Under Concentration-Time Curve From Zero to Time 168 (AUC[-168]) of Necitumumab||Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.|||ug*hour(h)/mL||Geometric Coefficient of Variation|Geometric Mean
2657315|NCT01606748|Primary|PK: Dose-Normalized Cmax of Cisplatin||Run-In Period Day 1 Cohort 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion; Cycle 1, Day 1: 0, 2, 2.03, 2.25, 3, 3.67 and 5.67 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.|||nanogram (ng)/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2657316|NCT01606748|Primary|PK: Dose-Normalized Cmax of Gemcitabine||Run-In Period Day 1 Cohort 1: 0,0.5,1,1.5,3,4,6.67 and 24h Post Start of Infusion; Cycle 1, Day 1: 0, 0.50, 1, 1.5, 3, 4.67, 6.67 and 24 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK. Per protocol, no data were collected for this assessment for participants in Cohort 2.|||nanogram(ng)/mL/mg||Geometric Coefficient of Variation|Geometric Mean
2657317|NCT01606748|Primary|Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Necitumumab||Run-In Period Day 3 Cohort 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 Hour (h) Post Start of Infusion; Cycle 1, Day 1: 0, 0.83, 1.33, 1.83, 3.83, 7.5, 24.83, 72 and 168 h Post Start of Infusion|All participants who received at least one dose of study drug and had evaluable data for PK.|||microgram/milliliter (ug/mL)||Geometric Coefficient of Variation|Geometric Mean
2657318|NCT01606735|Primary|Anterior Chamber Cell Count at Day 8 Post-Treatment|This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment. The proportion of patients with anterior chamber cell count = 0 at Day 8 for each dosage group will be compared.|8 days post-treatment||||percentage of patients with ACC clearing||95% Confidence Interval|Number
2657319|NCT01606709|Secondary|Quality of Life Survey After Ovarian Stimulation and GnRHa or hCG Trigger||At baseline and up to 7 days after trigger of oocyte maturation|Too few patients completed survey to meaningfully analyze data||||||
2657320|NCT01606709|Primary|Endometrial Gene Expression Profile|Microarray of gene expression in the midluteal phase|7 days after trigger of oocyte maturation|Inadequate RNA quality to completely analyze gene expression||||||
2657321|NCT01606670|Secondary|Change From Baseline to Visit 2 in the Short-form Parkinson's Disease Questionnaire (PDQ-8) Total Score|The PDQ-8 is a self-administered 8 item questionnaire that assesses the overall health status. The questions will be rated from 0 (never) to 4 (always [or cannot do at all]). The total score ranges from 0 (never) to 32 (always [or cannot do at all]) with lower scores indicating a better health status.|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Full Analysis Set (FAS). The FAS includes all enrolled patients who had applied the rotigotine transdermal patch at least once and for whom valid data for the primary effectiveness variable were available from Baseline and a subsequent routine visit.|||units on a scale||Standard Deviation|Mean
2657322|NCT01606670|Secondary|Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III|The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living' and Part III 'Motor Function'. They consist of 40 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part II+III ranges from 0 (normal) to 160 (worst score possible).|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Of the 70 patients in the Full Analysis Set (FAS), 68 patients had complete data for UPDRS Part II and 67 patients had complete data for UPDRS Part III. Thus, of the 70 patients in the FAS, 67 patients are included in the analysis of this outcome measure.|||units on a scale||Standard Deviation|Mean
2657323|NCT01606670|Secondary|Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part III|The UPDRS is a scale for the assessment of function in Parkinson's disease. Part III measures 'Motor Function'. It consists of 14 items with 27 questions, each ranging from 0 (normal) to 4 (severe abnormalities). The sum score of the UPDRS Part III ranges from 0 (normal) to 108 (worst score possible).|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Of the 70 patients in the Full Analysis Set (FAS), 67 patients had complete data for UPDRS Part III and are included in the analysis of this outcome measure.|||units on a scale||Standard Deviation|Mean
2657324|NCT01606670|Secondary|Change From Baseline to Visit 2 in the Sum Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II|The UPDRS is a scale for the assessment of function in Parkinson's disease. Part II measures 'Activities of Daily Living'. It consists of 13 questions, each ranging from 0 (none) to 4 (severe abnormalities). The sum score of the UPDRS Part II ranges from 0 (normal) to 52 (worst score possible).|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Of the 70 patients in the Full Analysis Set (FAS), 68 patients had complete data for UPDRS Part II and are included in the analysis of this outcome measure.|||units on a scale||Standard Deviation|Mean
2657325|NCT01606670|Primary|Change From Baseline to Visit 2 in the Sum Score Calculated From the 4 Items of the Affective Dimension of the Pain Description List (Schmerzbeschreibungsliste SBL, Question 10) of the German Pain Questionnaire|"The Pain Description List (SBL, question 10) is part of the validated German Pain Questionnaire (DSF).~The SBL consists of a 12 item list of adjectives. Each adjective is ranked from 0 (not applicable) to 3 (exactly applicable).~8 of the 12 adjectives will be used to assess the sensory items of pain and 4 adjectives to describe the affective items of pain.~The 8 sensory items are used to assess qualitative description of pain. For the 4 affective pain items, a sum score ranges from 0 (not applicable) to 12 (exactly applicable). Values above 8 can be considered noticeable."|From Baseline (Day 0) to Visit 2 (after at least 4 weeks on a maintenance dose of Neupro®)|Full Analysis Set (FAS). The FAS includes all enrolled patients who had applied the rotigotine transdermal patch at least once and for whom valid data for the primary effectiveness variable were available from Baseline and a subsequent routine visit.|||units on a scale||Standard Deviation|Mean
2657326|NCT01606319|Secondary|Health Care Utilization|frequency of unscheduled physician visits, emergency department visits or hospitalizations for asthma|last 46 weeks of 48 week treatment period|Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.|||unscheduled health visits per 46 weeks||95% Confidence Interval|Mean
2657327|NCT01606319|Secondary|Asthma Rescue Medication Use|average albuterol rescue use per week, measured by electronic diary|last 46 weeks of 48 week treatment period|Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.|||inhalations per week||95% Confidence Interval|Mean
2657328|NCT01606319|Secondary|Asthma Control Days|proportion of study days on which asthma was controlled, measured by electronic diary|last 46 weeks of 48 week treatment period|Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.|||proportion of days||95% Confidence Interval|Mean
2657329|NCT01606319|Primary|Exacerbation Frequency|the number of asthma exacerbations requiring systemic corticosteroids|last 46 weeks of 48 week treatment period|Two participants in the ibuprofen arm dropped out of the study during the first two weeks of the study and were not included in the analysis per the pre-specified analysis plan.|||asthma exacerbations per 46 weeks||95% Confidence Interval|Mean
2657330|NCT01606306|Primary|Differential Response to the Three Therapies Based on Fixed Threshold Criteria for the Following Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations and Asthma Control Days.|The primary outcome was differential response to the three therapies on the basis of fixed threshold criteria for the following asthma control measures, which encompassed domains of risk and impairment: the time from the start of the treatment period to an asthma exacerbation treated with systemic corticosteroids, and the annualized number of asthma control days (ACDs) from within that period. ACDs were defined as full calendar days without symptoms, rescue medication use, or unscheduled healthcare visits. Children were defined as differential responders if, first, the time to an asthma exacerbation was at least four weeks longer, or second, if the number of annualized ACDs was at least 31 days more for one treatment than another, in that order. If neither threshold was met, the participant was considered a non differential responder. Differential response was determined in children completing at least two treatment periods and at least 50% of the daily diary entries for each period.|The last 14 weeks of each 16-week treatment period|Differential response was determined in children completing at least two treatment periods and at least 50% of the daily diary entries for each period.|||probability||95% Confidence Interval|Number
2657331|NCT01606254|Secondary|Number of Participants With Clinical Global Impression Severity (CGI-S) Score|"The CGI-S rating scale is a 7 point (1-absent, 2-minimal, 3-mild, 4-moderate, 5-moderate severe, 6-severe, 7-extreme) global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to normal, not at all ill and a rating of 7 is equivalent to among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Day 8, 22, 50, 78 and 92|The PPS included all participants who were enrolled in the study, received study medication at least once and had at least one efficacy evaluation. LOCF imputation method was used. Here ‘n’ signifies participants evaluable for this measure at specified time point for each arm group.|||Participants|||Number
2657477|NCT01605825|Other Pre-specified|Manual Dexterity as Measured by the Box and Block Test||Days 1, 8, 15, 22, 29, and 36|||||||
2657332|NCT01606254|Secondary|Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline, Day 8, 22, 50, 78 and 92|Per protocol set (PPS) included all participants who were enrolled in the study, received study medication at least once and had at least one efficacy evaluation. Last observation carried forward (LOCF) imputation method was used. Here ‘n’ signifies participants evaluable for this measure at specified time point for each arm group.|||units on a scale||Standard Deviation|Mean
2657333|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 218|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
2657334|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 162|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
2657335|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 120|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
2657336|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 92|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
2657337|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 78|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
2657338|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 50|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
2657339|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 22|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Participants|||Number
2657340|NCT01606254|Primary|Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8|The DIEPSS is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the average of the 8 item scores, for a total range of 0 (normal) to 4 (severe). Overall severity was assessed at 5 levels (0 [none, normal]; 1 [Very Mild]; 2 [Mild]; 3 [Moderate]; 4 [severe]).|Day 8|Safety analysis set included all participants who were enrolled in the study and received the study medication at least once.|||Participants|||Number
2657478|NCT01605825|Other Pre-specified|Motor and Sensory Function as Measured by the Fugl-Meyer Assessment (FMA)||Screening visit, Days 1, 8, 15, 22, 29, and 36|||||||
2657479|NCT01605825|Other Pre-specified|Walking Speed Measured by the Timed 25 Foot Walk Test (T25FW)||Screening visit, Days 1, 8, 15, 22, 29 and 36|||||||
2657341|NCT01606254|Primary|Paliperidone Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Days||Standard Deviation|Mean
2657342|NCT01606254|Primary|Plasma Paliperidone Concentration at Steady State (Css av)|The Css av is defined as value of average analyte concentration at steady-state (after 4 Intramuscular Injections of Paliperidone Palmitate).|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||ng/ml||Standard Deviation|Mean
2657343|NCT01606254|Primary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)|The AUCtau is a measure of the plasma paliperidone concentration from time zero to end of dosing interval. It is used to characterize drug absorption.|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||nanogram*hour per milliliter||Standard Deviation|Mean
2657344|NCT01606254|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone|The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||Days||Full Range|Median
2657345|NCT01606254|Primary|Maximum Observed Plasma Concentration (Cmax) of Paliperidone|The Cmax is defined as maximum observed analyte concentration.|Days 1, 8, 15, 22, 36, 50, 64, 67, 71, 74, 78, 85, 92, 106, 120, 134, 162, 190, 218 and early withdrawal|Pharmacokinetic analysis set included all participants who received the study medication and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||ng/ml||Standard Deviation|Mean
2657346|NCT01606254|Primary|Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92|The Cpredose at Day 92 is defined as the plasma paliperidone concentration obtained after the treatment interval of the study drug (that is 4 weeks) passed after the final dose (Day 92). The mean Cpredose at Day 92 was measured in ng/ml.|Day 92|Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||ng/ml||Standard Deviation|Mean
2657347|NCT01606254|Primary|Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64|The Cpredose at Day 64 is defined as the plasma paliperidone concentration obtained before a dose is given on Day 64. The mean Cpredose at Day 64 was measured in ng/ml.|Day 64|Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||ng/ml||Standard Deviation|Mean
2657348|NCT01606254|Primary|Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36|The Cpredose at Day 36 is defined as the plasma concentration obtained before a dose is given on Day 36. The mean Cpredose at Day 36 was measured in ng/ml.|Day 36|Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||ng/ml||Standard Deviation|Mean
2657349|NCT01606254|Primary|Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8|The pre-dose plasma concentration (Cpredose) at Day 8 is defined as the plasma concentration obtained before a dose is given on Day 8. The mean Cpredose at Day 8 was measured in nanogram per milliliter (ng/ml).|Day 8|Pharmacokinetic analysis set included all participants who received the study treatment and whose plasma drug concentrations were available. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||ng/ml||Standard Deviation|Mean
2657350|NCT01606228|Secondary|Daytime Drowsiness at Day 90|The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).|Day 90|Per Protocol (PP) population|||scores on a scale||Standard Deviation|Mean
2657351|NCT01606228|Secondary|Daytime Drowsiness at Baseline|The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).|Baseline|Per Protocol (PP) population|||scores on a scale||Standard Deviation|Mean
2657352|NCT01606228|Secondary|Quality of Sleep at Day 90|The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).|Day 90|Per Protocol (PP) population|||scores on a scale||Standard Deviation|Mean
2657353|NCT01606228|Secondary|Quality of Sleep at Baseline|The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).|Baseline|Per Protocol (PP) population|||scores on a scale||Standard Deviation|Mean
2657354|NCT01606228|Secondary|Patient Satisfaction With Paliperidone Treatment|Patients will be interviewed to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor).|90 days|Per Protocol (PP) population|||participants|||Number
2657355|NCT01606228|Secondary|Personal and Social Performance (PSP) Scores at Day 90|This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.|Day 90|Per Protocol (PP) population|||scores on a scale||Standard Deviation|Mean
2657356|NCT01606228|Secondary|Personal and Social Performance (PSP) Scores at Baseline|This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.|Baseline|Per Protocol (PP) population|||scores on a scale||Standard Deviation|Mean
2657357|NCT01606228|Secondary|Clinical Global Impression-Severity (CGIS) Scores at Day 90|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. The rating varies from Normal (not at all ill) to Extreme (among the most extremely ill patients)."|Day 90|Per Protocol (PP) population|||participants|||Number
2657358|NCT01606228|Secondary|Clinical Global Impression-Severity (CGIS) Scores at Baseline|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. The rating varies from Normal (not at all ill) to Extreme (among the most extremely ill patients)."|Baseline|Per Protocol (PP) population; participants for whom CGIS data was collected.|||participants|||Number
2657359|NCT01606228|Secondary|Positive and Negative Syndrome Scale (PANSS) Scores at Day 90|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Day 90|Per Protocol (PP) population|||scores on a scale||Standard Deviation|Mean
2657360|NCT01606228|Secondary|Positive and Negative Syndrome Scale (PANSS) Scores at Baseline|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline|Per Protocol (PP) population|||scores on a scale||Standard Deviation|Mean
2657361|NCT01606228|Primary|The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90)|The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.|Baseline, Day 90|Per Protocol (PP) population|||percentage of patients|||Number
2657362|NCT01606202|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of patients who experienced an adverse event during the study is presented.|Up to 61 days|All randomised patients who received at least one dose of study drug were included in the Safety population.|||participants|||Number
2657363|NCT01606202|Secondary|Change From Baseline in the Mean Sleep Disturbance Numerical Rating Scale Score at the End of Treatment|Each day patients recorded in their patient diary whether they woke during the previous night using the following scoring system: 0 = No, 1 = Once, 2 = Twice, 3 = More than twice, 4 = Awake most of the night. A negative value indicates an improvement from baseline.|0 - 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657364|NCT01606202|Secondary|Change From Baseline in the Mean Brief Pain Inventory Score at the End of Treatment|The Brief Pain Inventory is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score is calculated as the arithmetic mean of the four severity items(range 0-10). A negative value indicates an improvement in worst pain score from baseline.|0 - 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657365|NCT01606202|Secondary|Number of Subjects Who Reported an Improvement in Their Overall Condition in the Patient Global Impression of Change at the End of Treatment|The Patient Global Impression of Change asked patients to give their impression of the overall change in their condition during the study at the end of treatment using the following scale: 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse. The number of patients who scored their condition as 1, 2, or 3 (improved) is presented.|Up to 51 days|All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.|||participants|||Number
2657366|NCT01606202|Secondary|Change From Baseline in the Mean Caregiver Strain Index Score at the End of Treatment|Carers were asked at baseline and end of treatment to complete the Caregiver Strain Index, as a measure of the strain they felt from being a carer, the maximum possible score being 13. A negative value from baseline indicates an improvement.|Up to 51 days|All caregivers of patients in the current study who responded to the caregiver strain index questionnaire were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657367|NCT01606202|Secondary|Change From Baseline in Mean Spitzer Quality of Life Index Score at the End of Treatment|The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient is required to choose the one that best describes their quality of life during the last week. Choice 1 is scored 2, choice 2 is scored 1 and choice 3 is scored 0. The total Spitzer is the unweighted sum of the five scores. The scale is 0 (bad) to 10 (good). A positive value indicates an improvement from baseline.|Up to 51 days|All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2658156|NCT01600222|Primary|Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After Adrenocorticotrophic Hormone-challenge (ACTH-challenge)|HPA-axis testing by means of the rapid standard-dose cosyntropin test (ACTH-challenge test) for detection of adrenal suppression.|Day 28|Per protocol analysis set.|||Subjects|||Number
2657368|NCT01606202|Secondary|Change From Baseline in the Mean Short Orientation Memory Function Concentration Test Score at the End of Treatment|"Patients were asked at baseline and end of treatment, to complete the Short Orientation Memory Function Concentration Test as a measure of cognitive function. The minimum score is 0 and maximum of 28 which denoted good cognitive function .~A negative value from baseline indicates a deterioration."|Up to 51 days|All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657369|NCT01606202|Secondary|Change From Baseline in Modified Ashworth Scale Score at the End of Treatment|"The Modified Ashworth Scale is a five-point scale conducted on four pre-identified muscle groups. Only the lower limb was assessed because not all Spinal Cord Injury patients upper limb disability. The assessor used the Modified Ashworth scale ranging from 0 (No increase in muscle tone) to 4 (Affected part(s) rigid in flexion or extension) to rate the muscle tone for knee and ankle for the left and right sides separately at a pre-dose visit and at the end of treatment. The average of the four individual scores and was taken. A negative value indicates an improvement from baseline."|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657370|NCT01606202|Secondary|Change From Baseline in the Percentage of Days on Which Spasticity Was Experienced at the End of Treatment|Each day, just before going to bed, patients recorded in their patient diary whether they had experienced any spasticity that day or not. The percentage of days on which spasticity was experienced (spasticity incidence) was calculated and summarised analogously to the primary efficacy parameter of Numerical Rating Scale pain score. A negative value from baseline indicates an improvement.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.|||percentage of days||Standard Deviation|Mean
2657371|NCT01606202|Secondary|Change From Baseline in Mean Spasticity Severity Numerical Rating Scale Scores the End of Treatment.|"Each day at bed time patients recorded whether they experienced any spasticity that day and, if yes, the overall level of spasticity experienced was quantified using an Numerical Rating Scale from 0 = Mildest ever spasticity to 10 = Worst ever spasticity. The mean spasticity severity scores and the changes from baseline to End of Treatment were to be calculated. A negative value indicates an improvement from baseline."|0 - 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657372|NCT01606202|Secondary|Change From Baseline in the Percentage of Days on Which Spasm Was Experienced at the End of Treatment|Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day. The percentage of days on which spasm was experienced were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.|||percentage of days||Standard Deviation|Mean
2657373|NCT01606202|Secondary|Change From Baseline in Mean Spasm Severity Numerical Rating Scale Score at the End of Treatment|"Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day and, if yes, recorded the overall level of the spasm(s) experienced using an Numerical Rating Scale spasm scale ranging from 0 = Mildest ever spasm to 10 = Worst ever spasm. The mean spasm severity scores were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement."|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657374|NCT01606202|Secondary|Change From Baseline in the Mean Percentage of Days on Which Escape Medication Was Used at the End of Treatment|The percentage of days that subjects used escape medication was analysed and is presented as the mean change from baseline at the end of treatment. A negative value from baseline indicates an improvement.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.|||percentage of days||Standard Deviation|Mean
2657375|NCT01606202|Primary|Change From Baseline in Mean Central Neuropathic Pain 11-Point Numerical Rating Scale Scores at the End of Treatment (up to 51 Days).|The Central Neuropathic Pain Numerical Rating Scale score was recorded three times daily, in the morning (on waking), at lunchtime and in the evening using the scale, 0 = 'No Pain' and 10 = 'Worst Possible Pain'. Patients were instructed to relate 'No Pain' to the time before the start of their spinal cord injury. End of Treatment was defined as the mean of the last seven days in the study or the mean of the last three days if the subject withdrew. A negative value indicates an improvement in pain score from baseline.|Up to 51 days|All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657376|NCT01606189|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of patients who experienced an adverse event during the course of study is presented.|Up to 114 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.|||participants|||Number
2657377|NCT01606189|Secondary|Change From Baseline in the Mean 12-Item General Health Questionnaire Score at the End of Each Treatment Period (Each Lasting 14-20 Days).|The 12-Item General Health Questionnaire consisted of 12 general health questions. Each question was scored on a zero to three scale, where zero represented the better assessment. The total score was the unweighted sum of the 12 scores, ranging from zero to 36. A negative value indicates an improvement from baseline.|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657378|NCT01606189|Secondary|Change From Baseline in the Mean Pain Disability Index Score at the End of Each Treatment Period (Each Lasting 14-20 Days).|"The Pain Disability Index consisted of seven assessments representing different aspects of disability due to pain. Each assessment was scored on a zero to 10 scale, where zero equated with no disability and 10 equated with total disability. The total Pain Disability Index score was the unweighted sum of the seven pain scores, ranging from zero to 70. A negative value indicates an improvement from baseline."|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657379|NCT01606189|Secondary|Change From Baseline in the Number of Patients Who Reported 'No Pain' or 'Mild Pain' Using a McGill Pain Questionnaire Part 3 Score for 'Strength of Pain at Present' at the End of Each Treatment Period (Each Lasting 14-20 Days)|"Part 3 of the questionnaire recorded the strength of pain at present. Results were recorded in six categories which were classified as No Pain, Mild, Discomforting, Distressing, Horrible and Excruciating. The change from baseline in the number of patients who reported No Pain or Mild Pain at the end of the respective treatment periods is presented. An increase in number indicates an improvement from baseline."|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.|||participants|||Number
2657380|NCT01606189|Secondary|Change From Baseline in the Mean McGill Pain Questionnaire Part 2 Score for 'Intensity of Pain' at the End of Each Treatment Period (Each Lasting 14-20 Days)|"Part 2 of the questionnaire recorded the intensity of pain at present. Results were recorded on a VAS ranging from zero No pain to 100 Worst possible pain. Intensity of pain was summarised and analysed in the same manner as the primary efficacy parameter of Box Scale-11 pain score. A negative value indicates an improvement from baseline."|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657381|NCT01606189|Secondary|Change From Baseline in the Mean McGill Pain Questionnaire Part 1 Score for 'Total Pain Intensity' at the End of Each Treatment Period (Each Lasting 14-20 Days)|"Part 1 of the questionnaire related to the intensity of 15 different types of pain. Intensity was recorded separately for each type of pain on a zero to three scale, where zero = None, one = Mild, two = Moderate and three = Severe. The total intensity was defined as the unweighted sum of the 15 scores, giving a minimum possible score of zero (lowest pain score) and a maximum possible score of 45 (highest pain score). The distribution of each of the 15 types of pain was summarised at baseline and for each treatment. A negative value indicates an improvement in pain from baseline."|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657382|NCT01606189|Secondary|Change From Baseline in the Mean Box Scale-11 Sleep Quality Score at the End of Each Treatment Period (Each Lasting 14-20 Days).|"Each day patients recorded in their patient diary the quality of their sleep during the previous night using a Box Scale-11 sleep score ranging from zero Worst Imaginable to 10 Best Imaginable. The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A positive value indicates an improvement from baseline."|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657383|NCT01606189|Secondary|Change From Baseline in the Mean Sleep Disturbance Score at the End of Each Treatment Period (Each Lasting 14-20 Days).|"Each day patients recorded in their patient diary the number of times they were woken due to pain during the previous night. The results were recorded as None, Once, Twice and More Than Twice and converted to a four point scale, zero to three respectively. The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A negative value indicates an improvement from baseline."|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657384|NCT01606189|Primary|Change From Baseline in the Mean Box Scale-11 Pain Review Score at the End of Each Treatment Period (Each Lasting 14-20 Days)|"Each day patients recorded in their patient diary, the severity of their pain during the previous 24 hours using a Box Scale-11 pain score ranging from zero no pain at all to 10 pain as bad as you can imagine. The Box Scale-11 pain score endpoint for each assessment period was the average of all available data recorded during the seven whole days prior to the visit immediately subsequent to that period, but only including data from Day 8 onwards. A negative value indicates an improvement in pain score from baseline."|Up to 74 days|All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657385|NCT01606176|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of patients who experienced an adverse event in the study is presented.|0 - 65 days|All patients who entered the study, were randomised, received at least one dose of study medication and yielded on-treatment efficacy data were included in the safety analysis.|||participants|||Number
2657386|NCT01606176|Secondary|Patient Global Impression of Change - Multiple Sclerosis Subset.|"The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being Very Much Improved or Much Improved is presented."|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.|||participants|||Number
2657387|NCT01606176|Secondary|Change From Baseline in Mean Spitzer Quality of Life Index Scores (Multiple Sclerosis Subset) at 3 Weeks.|The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657388|NCT01606176|Secondary|Change From Baseline in Mean Brief Pain Inventory (Short Form) Scores (Multiple Sclerosis Subset) at 3 Weeks.|The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A reduction in score from baseline indicates an improvement.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657389|NCT01606176|Secondary|Change From Baseline in Mean Pain Disability Index Scores at 3 Weeks.|"The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero no disability to 10 total disability scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement."|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657390|NCT01606176|Secondary|Change From Baseline in Mean Sleep Disturbance Scores (Multiple Sclerosis Subset) at 3 Weeks.|"Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as No, Once, Twice, More than twice and Awake most of the night; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement."|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657391|NCT01606176|Secondary|Use of Analgesic Escape Medication - Multiple Sclerosis Subset.|The percentage of days on treatment on which escape medication was used is presented.|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.|||percentage of days||Standard Deviation|Mean
2657392|NCT01606176|Secondary|Change From Baseline in Mean Pain Box Scale-11 Scores (Multiple Sclerosis Subset) at 3 Weeks.|"Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero no pain to 10 worst possible pain. Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement."|0 - 3 weeks|Patients whose entry into the study was as a result of pain related to Multiple Sclerosis were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657393|NCT01606176|Secondary|Patient Global Impression of Change at the End of 3 Weeks of Treatment.|"The Patient Global Impression of Change consisted of a single question relating to improvement in overall condition since the start of the study. The results were recorded as Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse and were converted to a seven point scale ranging from one to seven, respectively. The number of patients who reported being Very Much Improved or Much Improved is presented."|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.|||participants|||Number
2657394|NCT01606176|Secondary|Change From Baseline in Mean Spitzer Quality of Life Index Scores at 3 Weeks.|The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient was required to choose the one that best described their quality of life during the last week. Choice 1 is scored two, Choice 2 is scored one and Choice 3 is scored zero. The total Spitzer Quality of Life Index was calculated as the unweighted sum of the five scores. A reduction in score from baseline indicates an improvement.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657395|NCT01606176|Secondary|Change From Baseline in Mean Total Brief Pain Inventory (Short Form) Score at 3 Weeks.|The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score was calculated as the arithmetic mean of the four severity items (range 0-10). The minimum value is zero and maximum is 10. A reduction in score from baseline indicates an improvement.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657396|NCT01606176|Secondary|Change From Baseline in Mean Total Pain Disability Index Score at 3 Weeks.|"The index consists of seven assessments of pain (representing different aspects) with each assessment scored on a zero no disability to 10 total disability scale. The total Pain Disability Index was calculated as the un-weighted sum of the seven pain scores; if one or more of the pain scores were missing then the total Pain Disability Index was set to missing. A reduction in score from baseline indicates and improvement."|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657397|NCT01606176|Secondary|Change From Baseline in Mean Sleep Disturbance Score at 3 Weeks.|"Each day patients were asked to record in their patient diary, whether or not they were woken due to pain the previous night. Answers were recorded as No, Once, Twice, More than twice and Awake most of the night; these were converted to a five point scale, zero to four, respectively. Sleep disturbance was summarised and analysed in the same manner as the analysis of the primary efficacy parameter of Box Scale-11 pain score. A negative value from baseline indicates and improvement."|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657398|NCT01606176|Secondary|Use of Analgesic Escape Medication.|The percentage of days on treatment on which escape medication was used is presented.|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.|||percentage of days||Standard Deviation|Mean
2657760|NCT01603368|Secondary|Length Gain (SD)|In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.|At 28th day of life||||change in standard deviations||Standard Deviation|Mean
2657399|NCT01606176|Primary|Change From Baseline in Mean Pain Box Scale-11 Score at 3 Weeks.|"Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero no pain to 10 worst possible pain. Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement."|0 - 3 weeks|All patients who were randomised, received at least one actuation of study medication and completed at least one set of efficacy assessments were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657400|NCT01606150|Secondary|Premature Infant Pain Profile (PIPP) Score|PIPP score assigned by a blinded outcome assessor by viewing video tapes of the infant's face during the procedure and vital sign changes during that time frame|data collected during the procedure, PIPP score assigned within one month by viewing collected data|||||||
2657401|NCT01606150|Primary|Lumbar Puncture Success Rate|Success defined as cerebrospinal fluid for a culture and red blood cell count less than 1000|immediately following the procedure|||||||
2657402|NCT01606137|Secondary|Investigator Global Assessment at the Last Study Visit in Subjects With Multiple Sclerosis.|"Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of much worse, worse, no change, better, much better. The number of subjects rated by the investigator as better or much better at the last study visit is presented."|Up to 1051 days.|All subjects who entered the study from a multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
2657403|NCT01606137|Secondary|Investigator Global Assessment at the Last Study Visit in Subjects With Pain.|"Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of much worse, worse, no change, better, much better. The number of subjects rated by the investigator as better or much better at the last study visit is presented."|Up to 1051 days.|All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
2657404|NCT01606137|Secondary|Investigator Global Assessment at the Last Study Visit in Subjects With Central Neuropathic Pain.|"Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of much worse, worse, no change, better, much better. The number of subjects rated by the investigator as better or much better at the last study visit is presented."|Up to 1051 days.|All subjects who entered the study from a central neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
2657405|NCT01606137|Secondary|Investigator Global Assessment at the Last Study Visit in Subjects With Neuropathic Pain Due to Multiple Sclerosis.|"Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of much worse, worse, no change, better, much better. The number of subjects rated by the investigator as better or much better at the last study visit is presented."|Up to 1051 days|All subjects who entered the study from a parent RCT investigation neuropathic pain due to multiple sclerosis, and who received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
2657406|NCT01606137|Secondary|Investigator Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.|Up to 1051 days.|All subjects who entered the study from a multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
2657407|NCT01606137|Secondary|Subject Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.|Up to 1051 days|All subjects who entered the study from a multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
2657408|NCT01606137|Secondary|Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.|Up to 1051 days|All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
2657409|NCT01606137|Secondary|Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.|Up to 1051|All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
2657410|NCT01606137|Secondary|Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.|Up to 1051days|All subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
2657411|NCT01606137|Secondary|Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.|Up to 1051 days|All subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
2668019|NCT01509677|Secondary|Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (VEGF (pg/mL))||Baseline to 14 weeks||||pg/mL||Standard Error|Least Squares Mean
2657412|NCT01606137|Secondary|Investigator Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.|Up to 1051 days|All multiple sclerosis subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
2657413|NCT01606137|Secondary|Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.|Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.|Up to 1051 days|All multiple sclerosis subjects who entered the study from a neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||participants|||Number
2657414|NCT01606137|Secondary|Change From Parent Study Baseline in Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.|"Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = best possible and 10 = worst possible. A negative value indicates an improvement in score from baseline."|0 - 52 weeks.|All subjects who entered the study from a pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
2657415|NCT01606137|Secondary|Change From Parent Study Baseline in Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment in Multiple Sclerosis Subjects.|"Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = best possible and 10 = worst possible. A negative value indicates an improvement in score from baseline."|0 - 52 weeks.|All subjects who entered the study from a neuropathic pain in multiple sclerosis parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
2657416|NCT01606137|Secondary|Change From Parent Study Baseline in Central Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.|"Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = best possible and 10 = worst possible. A negative value indicates an improvement in score from baseline."|0 - 52 weeks.|All subjects who entered the study from a central neuropathic pain parent RCT and received at least one actuation of study medication were included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
2657417|NCT01606137|Secondary|Change From Parent Study Baseline in Spasticity 0-10 Numerical Rating Scale Score After 52 Weeks of Treatment.|"Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = best possible and 10 = worst possible. A negative value indicates an improvement in score from baseline."|0 - 52 weeks|All subjects who entered the study from a parent randomised controlled trial (RCT) investigating the efficacy of GW-1000-02 in the treatment of spasticity associated with multiple sclerosis, and who received at least one actuation of study medication were included in the efficacy analysis.|||units on a scale||Standard Deviation|Mean
2657418|NCT01606137|Primary|Incidence of Adverse Events as a Measure of Subject Safety.|Following data entry, all adverse events were medically encoded using the Medical Dictionary for Regulatory Activities (MedDRA) 6.0. All subjects who experienced an adverse event during the treatment period is presented.|Up to 1051 days|All subjects who took part in the extension study were included in the analysis.|||participants|||Number
2657419|NCT01606124|Secondary|Tolerability as Estimated Using the Percent Dose of Treatment Received at 6 Months|Tolerability as estimated using the percent dose of treatment received for each patient by dividing the total dose received by the targeted (i.e., protocol specified) total dose.|6 months||||percentage of targeted dose||Standard Deviation|Mean
2657420|NCT01606124|Primary|Percent Change in Rectal ACF, Pre- and Post Intervention at 6 Months|The primary endpoint is based on a modified intent-to-treat procedure which includes all patients with baseline and 6-month ACF data. The percent change in rectal ACF (≤ 15 cm from the anal verge) for each patient is calculated as their Pre-Registration number of rectal ACF minus the number of rectal ACF present at the 6-month post-intervention exam, divided by the number of rectal ACF present at Pre-Registration times 100.|6 months|Patients with baseline and 6-month ACF data were included in this analysis.|||percentage change||Standard Deviation|Mean
2657421|NCT01606007|Secondary|Adjusted Mean Change From Baseline in Body Weight at Week 24|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. Body weight measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue.|Baseline (Week 0) and at Week 24|All randomized participants who received study medication and had nonmissing body weight values at baseline and Week 24|||Body weight Kg||95% Confidence Interval|Mean
2657422|NCT01606007|Secondary|Adjusted Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF])|Therapeutic glycemic response is defined as HbA1c <7.0%. Data after rescue medication was excluded from this analysis. HbA1c was measured as a percent of hemoglobin.|At Week 24|All randomized participants who received study medication and were not missing baseline and Week 24 (LOCF) values|||% of Participants||95% Confidence Interval|Number
2657423|NCT01606007|Secondary|Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. FPG measurements were obtained at Week 24 in the doubleblind period, including observations prior to rescue.|Baseline (Week 0) and at Week 24|All randomized participants who received study medication and had nonmissing PPG values at baseline and Week 24|||mg/dL||95% Confidence Interval|Mean
2657424|NCT01606007|Secondary|Adjusted Mean Change From Baseline in 2-hour Post Prandial Glucose (PPG) From a Liquid Meal Tolerance Test (MTT) at Week 24 (Last Observation Carried Forward [LOCF])|Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. PPG measurements were obtained at week 24 in the doubleblind period, including observations prior to rescue.|Baseline (Week 0) and at Week 24|All randomized participants who received study medication and had nonmissing PPG values at baseline and Week 24 (LOCF)|||MG/DL PPG||95% Confidence Interval|Mean
2657425|NCT01606007|Primary|Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24|HbA1c was measured as percent of hemoglobin by a central laboratory. Baseline was defined as the last assessment on or prior to the date of the first dose of the double-blind study medication. HbA1c measurements were obtained at Week 24 in the double-blind period, including observations prior to rescue.|Baseline (Week 0) and at Week 24|All randomized participants who received study medication and had nonmissing HbA1c values at baseline and Week 24|||% HbA1c||95% Confidence Interval|Mean
2657426|NCT01605942|Secondary|Plasma Levels of Dexamethasone|Levels of dexamethasone in plasma are evaluated. Plasma is the fluid portion of the blood.|Day 2, Day 7, Day 14|Pharmacokinetic: all patients who received dexamethasone and consented to pharmacokinetic analysis.|||Nanograms/Milliliter (ng/mL)||Standard Deviation|Mean
2657427|NCT01605942|Primary|Number of Patients With Clearance of Anterior Chamber Inflammation|The anterior chamber is the area in front of the iris (colored part of the eye). Inflammation is measured on a scale ranging from 0 (best) to 8 (worst).|Up to Day 71|Safety: all patients who received study treatment at randomization/surgery (day 1)|||Patients|||Number
2657428|NCT01605916|Secondary|AUC(0-12) of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2657429|NCT01605916|Secondary|Tmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||hour||Full Range|Median
2657430|NCT01605916|Secondary|Cmax of Docetaxel Following Intravenous Infusion of Docetaxel 60 mg/m2|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of docetaxel following intravenous infusion of docetaxel 60 mg/m2 in combination with Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2657431|NCT01605916|Primary|AUC(0-12) of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2657432|NCT01605916|Primary|Tmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||hour||Full Range|Median
2657433|NCT01605916|Primary|Cmax of N-desmethyl Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2657434|NCT01605916|Primary|AUC(0-12) of Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2657435|NCT01605916|Primary|Tmax of Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||hour||Full Range|Median
2657436|NCT01605916|Primary|Cmax of Selumetinib During Oral Twice Daily Dose of Selumetinib|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib during oral twice daily dose of Selumetinib|Day 8: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2657437|NCT01605916|Primary|AUC(0-12) of N-desmethyl Selumetinib After Single Dose|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dose) of N-desmethyl Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2657438|NCT01605916|Primary|Tmax of N-desmethyl Selumetinib After Single Dose|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose|Pharmacokinetic Analysis Set|||hour||Full Range|Median
2657439|NCT01605916|Primary|Cmax of N-desmethyl Selumetinib After Single Dose|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of N-desmethyl Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose|Pharmacokinetic Analysis Set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2657440|NCT01605916|Primary|AUC(0-12) of Selumetinib After Single Dose|Pharmacokinetic parameter (AUC(0-12): area under the plasma concentration-time curve from zero to 12 hours post-dosey) of Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12 hours post-dose|Pharmacokinetic Analysis Set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2657441|NCT01605916|Primary|Tmax of Selumetinib After Single Dose|Pharmacokinetic parameter (tmax: time to reach the maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose|Pharmacokinetic Analysis Set|||hour||Full Range|Median
2657442|NCT01605916|Primary|Cmax of Selumetinib After Single Dose|Pharmacokinetic parameter (Cmax: maximum plasma concentration) of Selumetinib following single oral dose of Selumetinib|Day 1: 0, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose|Pharmacokinetic Analysis Set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2657908|NCT01602341|Secondary|Number of Participants With Local Tolerability Symptoms|Participants who experienced local tolerability symptoms: mild itching or burning/stinging at sites of study drug application were reported in this measure.|Baseline up to Day 29|Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.|||Participants|||Count of Participants
2657443|NCT01605903|Primary|Number of Participants With Level 3 Postoperative Hemorrhage|Postoperative hemorrhage is defined as any history of bleeding occurring within the 14 day postoperative period. Hemorrhage will be stratified into 3 levels of severity. Level 1: includes children with a history of postoperative bleeding evaluated and/or treated by a physician in the emergency room, inpatient unit or operating room; Level 2: children requiring inpatient admission for postoperative bleeding regardless of the need for operative intervention; Level 3: children requiring inpatient admission and return to the operating room for control of post-tonsillectomy hemorrhage.|Data about post-tonsillectomy bleeding will be obtained after the end of a 14-day postoperative period.||||Participants|||Count of Participants
2657444|NCT01605890|Secondary|Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 24||Week 24|Participants with available measurement|||Participants|||Count of Participants
2657445|NCT01605890|Secondary|Minimal Median of the Lower Dimension Out of the 4 Dimensions of the Quality of Life Questionnaire|"The quality of life questionnaire is the Professional Quality of Life (PROQOL) questionnaire, including 4 dimensions:~Physical health and symptoms, Relationship with others, Mental and cognitive functioning and Treatment impact For each scale, a score ranging from 0 (the worst answer) to 100 (the best answer) is calculated."|from Week 0 to Week 48|Participants with available PROQOL questionnaire|||Score on a scale||Inter-Quartile Range|Median
2657446|NCT01605890|Secondary|Number of Participants With >6 Copies of HIV-2 DNA in Plasma at Week 48||at Week 48|Participants with available measurements|||Participants|||Count of Participants
2657447|NCT01605890|Secondary|Number of Participants With Treatment Switch or Discontinuation|Overall (regardless of the molecule)|from Week 0 to Week 48||||Participants|||Count of Participants
2657448|NCT01605890|Secondary|Number of Virological Failure Participants With Resistance Mutations|Virological failure is defined as plasma HIV-2 RNA load over or equal to 100 copies/mL after plasma HIV-2 RNA load below 100copies/mL, confirmed with a retest within the 4 following weeks. The number and type of mutations in the RT and integrase genes compared to week 0 is being reported.|from Week 0 to Week 48||||Participants|||Count of Participants
2657449|NCT01605890|Secondary|Minimal Observed Percentage of Participants With Moderate to Good Adherence Evaluated With ANRS Self-administered Questionnaire of Adherence||from Week 4 to Week 48|Number of participants with available questionnaire of adherence|||percentage of participants|||Number
2657450|NCT01605890|Secondary|Number of Participants With Clinical Progression|"Clinical progression is defined as the switch:~from category A to B, C or death.~from category B to C or death."|from Week 0 to Week 48||||Participants|||Count of Participants
2657451|NCT01605890|Secondary|Percentage of Patients With Plasma HIV-2 RNA < 40 Copies/mL||between Week 0 and Week 48||||percentage of participants|||Number
2657452|NCT01605890|Secondary|Median Change of CD4 Lymphocytes at Week 48||between Week 0 and Week 48||||cells/µL||Inter-Quartile Range|Median
2657453|NCT01605890|Secondary|Number of Clinical and Biological Events||from Week 0 to Week 48||||clinical and biological events|||Number
2657454|NCT01605890|Secondary|Median Change in CD4 Lymphocytes Count at Week 12||between Week 0 and Week 12||||cells/µL||Inter-Quartile Range|Median
2657455|NCT01605890|Primary|Percentage of Participants in Therapeutic Success|"The participants will be considered in therapeutic success at Week 48 if they did not present any of the following events:~Plasma HIV-2 RNA load over or equal to 100 copies/mL, starting from Week 24 and confirmed within the next 4 weeks,~CD4 lymphocytes gain below 100/mm3 at Week 48 compared to the CD4 lymphocytes counts average between Week-4 and Week 0,~Raltegravir permanent discontinuation,~Death from any cause,~New B or C events confirmed by an endpoint review committee"|at Week 48||||percentage of participants||95% Confidence Interval|Number
2657456|NCT01605877|Secondary|Percentage of Participants With Positive Response, Quality of Life Questions|"The participant completed a questionnaire, indicating (yes/no) if he/she experienced visual difficulty in every-day activities while not wearing spectacles. A positive response was defined as, Yes=visual difficulty."|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.|||percentage of participants|||Number
2657457|NCT01605877|Secondary|Percentage of Participants With Positive Response, Stereoscopic Vision Test|Stereopsis (the ability to perceive depth and 3-dimensional structure) was assessed binocularly under well-lit conditions at best distance using the Stereo Optical Company, Inc., Original Stereo Fly Test and polarized viewers. The participant was shown a series of symbols, with a positive response defined as correct identification of the 3-dimensional symbol. Responses were recorded for 3 symbols: Fly (easiest to perceive), animal, and circle (hardest to perceive).|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.|||percentage of participants|||Number
2657458|NCT01605877|Secondary|Mean Defocus Decimal VA (5 m)|Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly with the participant's best spectacle correction at a distance of 5 m using a chart. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.|||decimal||Full Range|Mean
2657459|NCT01605877|Secondary|Best Corrected Near (46 cm) Contrast Sensitivity|Near contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with the participant's best spectacle correction at a distance of 46 cm using the Functional Acuity Contrast Test (FACT). Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, 12, and 18 cycles per degree (cpd). Raw scores were transformed to logMar units. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.|||logMAR||Standard Deviation|Mean
2657514|NCT01605435|Primary|Percentage of Total Energy Intake Relative to Placebo|% of total energy relative to placebo - breakfast served 30 minutes post-placebo or ghrelin administration.|30 mins post-ghrelin or placebo|At the first visit all participants received s.c. placebo. The first two participants received 2 ,5, and 10ug/kg of ghrelin at visit 2,3 and 4 consecutively. The final three participants received 5,7.5, and 10ug/kg of s.c. ghrelin at visits 2,3 and 4 consecutively.|||percentage of placebo intake|||Number
2657460|NCT01605877|Secondary|Best Corrected Far (3 m) Contrast Sensitivity|Far contrast sensitivity (ie, the ability to detect slight changes in luminance before they become indistinguishable) was assessed binocularly with the participant's best spectacle correction at a distance of 3 m using the Vector Vision CSV 1000 illuminated box (one site) and the Vision Contrast Test System (other site). Contrast sensitivity was assessed at spatial frequencies of 1.5, 3, 6, 12, and 18 cycles per degree (cpd). For CSV 1000, contrast sensitivity was not measured at spatial frequency 1.5 cpd because there was no option for this frequency. Raw scores were transformed to logMar (logarithm of the minimum angle of resolution) units. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|This analysis population includes all implanted subjects.|||logMAR||Standard Deviation|Mean
2657461|NCT01605877|Secondary|Mean Best Distance (cm) for Distance Corrected Decimal Near VA|VA was tested monocularly at Day 1-2, Day 7-14, Day 30-60, Day 120-180, and Day 330-420 and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction using a chart. The participant indicated the distance (cm) at which best near vision was attained.|Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||centimeters||Standard Deviation|Mean
2657462|NCT01605877|Secondary|Mean Best Distance (cm) for Uncorrected Decimal Near VA|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 unaided using a chart. The participant indicated the distance (cm) at which best near vision was attained.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|"This analysis population includes all implanted subjects. Here, n is the number of participants with non-missing values at the specific time point for each arm group, respectively."|||centimeters||Standard Deviation|Mean
2657463|NCT01605877|Secondary|Uncorrected Decimal VA at Best Distance|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 using a chart at the distance of best near vision (cm) as decided by the participant. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
2657464|NCT01605877|Secondary|Distance Corrected Decimal VA (40 cm)|VA was tested binocularly using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
2657465|NCT01605877|Secondary|Uncorrected Decimal VA (40 cm)|VA was tested binocularly unaided at a distance of 40 cm using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
2657466|NCT01605877|Secondary|Distance Corrected Decimal VA (1 m)|VA was tested binocularly using a chart. Distance-corrected VA at 1 m is the VA at 1 m measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
2657467|NCT01605877|Secondary|Uncorrected Decimal VA (1 m)|VA was tested binocularly unaided at a distance of 1 m using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
2657468|NCT01605877|Primary|Distance-Corrected Decimal VA (50 cm)|VA was tested monocularly at the preoperative, Day 30-60, Day 120-180, and Day 330-420 visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 using a chart. Distance-corrected VA at 50 cm is the VA at 50 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
2657469|NCT01605877|Primary|Best Corrected Decimal VA (50 cm)|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 50 cm using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
2657470|NCT01605877|Primary|Best Corrected Decimal VA (5 m)|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 with the participant's best spectacle correction at a distance of 5 m using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
2657471|NCT01605877|Primary|Uncorrected Decimal VA (50 cm)|VA was tested monocularly at all visits and binocularly at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 50 centimeters (cm) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
2657472|NCT01605877|Primary|Uncorrected Decimal VA (5 m)|Visual acuity (VA) was tested monocularly (each eye separately) at all visits and binocularly (both eyes together) at Day 30-60, Day 120-180, and Day 330-420 unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.|Baseline (preoperative), Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420|This analysis population includes all implanted subjects.|||participants|||Number
2657473|NCT01605825|Other Pre-specified|Hand Strength as Measured by the Grip Test and Pinch Tests||Days 1, 8, 15, 22, 29, and 36|||||||
2657474|NCT01605825|Other Pre-specified|Clinician Global Impression (CGI) Scale||Days 8, 15, 22, 29 and 36|||||||
2657475|NCT01605825|Other Pre-specified|Subject Global Impression (SGI) Scale||Days 8, 15, 22, 29 and 36|||||||
2657480|NCT01605825|Primary|Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs)|"A TEAE is defined as any adverse event with date of onset (or worsening) on or after the start-date of double-blind treatment through 7 days after the last dose of double-blind treatment.~The severity categories of mild, moderate or severe, are defined below:~Mild is defined as causing no limitation of usual activities~Moderate is defined as causing some limitation of usual activities~Severe is defined as causing inability to carry out usual activities"|up to 36 days|Safety population. Number of participants analyzed is number of patients with TEAE's as described in outcome measure description. Excludes pre-treatment and post-treatment adverse events.|||participants|||Number
2657481|NCT01605799|Secondary|Change in Psychological Symptoms as Measured by the Brief Symptom Inventory (BSI-53)|"The BSI is a 53 item self-report scale used to measure nine primary symptom dimensions (somatization, obsessive-compulsive behavior, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism). Respondents rank each feeling item (e.g., your feelings being easily hurt) on a 5-point scale ranging from 0 (not at all) to 4 (extremely). Rankings characterize the intensity of distress during the past seven days. The total score is the sum of all responses [minimum = 0 (better outcome), maximum = 212 (worse outcome)]."|The BSI will be administered at Baseline or the first study visit and the end of treatment (Week 7)|The mean change in BSI between baseline and end of treatment will be measured using an intent to treat analysis.|||Units on a scale||95% Confidence Interval|Mean
2657482|NCT01605799|Primary|Change in PTSD Symptoms as Measured by the PCL|The PCL is a 17 item self-report measure of the 17 symptoms of PTSD per the DSM IV. Possible scores range from 17 (better outcome) to 85 (worse outcome).|PTSD symptoms will be assessed at Baseline or the first study visit and the end of treatment (Week 7)|The mean change in PCL score from baseline to end of treatment will be measured using an intent to treat analysis.|||Units on a scale||95% Confidence Interval|Mean
2657483|NCT01605669|Primary|Aortic Stenosis Acceleration Index Compared to Aortic Stenosis Severity|The ASAI measures the timing of the peak intensity of the systolic murmur and compares it to the total time in systole (S2-x/s2-s1) where s1 is the first heart sound; S2 is the second heart sound and x with the time between S1 and the peak intensity of the murmur. Aortic Stenosis severity will be measured by peak and mean aortic valve gradients as well as aortic valve area derived from the continuity equation. ASAI was averaged and compared to the mean aortic gradient. ROC curve was calculated for ASAI predicting a mean gradient of >30mmHg. ASAI of 34 was determined to provide the optimal combination of specificity and sensitivity and therefore set as the cut off point for significant Aortic Stenosis.|There is a single measurement taken on the day of enrollment. The ascultatory recording and echocardiogram will occur at the same visit. There will be no additional visits or study followup.||||participants|||Number
2657484|NCT01605617|Secondary|Change in Score on Overactive Bladder Questionnaire (QAB-q)|"The QAB-q is a self-administered, 33-item questionnaire containing a symptom bother and health related quality of life scale. Each item has a choice of 6 responses, ranging from not at all to a very great deal. Therefore, the total score could range from 33 (no discomfort) to 198 (great discomfort)."|Baseline, 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.||||||
2657485|NCT01605617|Secondary|Number of Urgency Episodes Scored by the Indevus Urgency Severity Scale (IUSS)|The IUSS has 4 levels: none, mild, moderate, and severe. An episode characterized as severe according to this scale would qualify as an urgency episode.|baseline, 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.||||||
2657486|NCT01605617|Secondary|Volume Voided Per Day||From baseline to 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.||||||
2657487|NCT01605617|Secondary|Number of Voids Causing Waking||From baseline to 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.||||||
2657488|NCT01605617|Secondary|Mean Change in Urinary Urge Incontinence Episodes in 24 Hours||Baseline, 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.||||||
2657489|NCT01605617|Primary|Number of Urinary Voids Per 24 Hours After 12 Weeks of Therapy||From baseline to 12 weeks post treatment|The study was terminated due to a low recruitment rate prior to subjects completing treatment.||||||
2657490|NCT01605552|Secondary|Change in Interleukin-6 (IL-6) From Pre- to Post- Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks|One case was excluded from the usual care group due to extreme values.|||change in pg/ml||Standard Deviation|Mean
2657491|NCT01605552|Secondary|Change in C-reactive Protein (CRP) From Pre- to Post- Treatment|A marker of systemic inflammation measured from blood samples collected at pre- and post-treatment.|0 and 12 weeks||||change in mg/L||Standard Deviation|Mean
2657492|NCT01605552|Secondary|Change in Depressive Symptoms Severity (SCL-20 Score) From Pre- to Post- Treatment|Self-reported depressive symptom severity was measured at pre- (0 weeks) and post- (12 weeks) treatment visits by the 20 depression items from the Symptom Checklist 90 (Hopkins Symptom Checklist depression scale; SCL-20). Each item on the scale ranges from 0 (not at all) to 4 (extremely). Total scores are the average across all response items and range from 0 to 4 with higher scores indicating greater levels of depressive symptoms.|0 and 12 Weeks|One participant in the usual care group did not complete the SCL-20 at the pre-treatment visit. Therefore a change score could not be computed for this participant. The remaining number of participants in usual care for this analysis was 13.|||Change in scores on a scale||Standard Deviation|Mean
2657493|NCT01605552|Primary|Change in Brachial Flow-Mediated Dilation (FMD) From Pre- to Post- Treatment|Patients will undergo ultrasound assessment of brachial FMD in accordance with established guidelines. After a 10-minute supine rest, high-resolution baseline images of the brachial artery will be obtained from 3 consecutive cardiac cycles. Next, the forearm cuff will be inflated to 250 mmHg for 5 minutes and then will be rapidly deflated. At 60 and 90 seconds post-deflation, images from 3 consecutive cardiac cycles will be acquired. FMD values will be computed as the % change in brachial diameter at either 60 or 90 seconds after cuff deflation.|0 and 12 weeks||||% increase in brachial diameter||Standard Deviation|Mean
2658685|NCT01596283|Secondary|Low Cardiac Output Time|Assess the impact of GDT compared to standard fluid therapy on the total time patients experience low cardiac output perioperatively|Up to the first 24 postoperative hours||||minutes||Standard Deviation|Mean
2657494|NCT01605539|Secondary|Vital Signs - Temperature|"Temperature (in degrees Fahrenheit) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Temperature will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)||||degrees F||Standard Error|Mean
2657495|NCT01605539|Secondary|Vital Signs - Respiratory Rate|"Respiratory rate (in breaths/min) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Respiratory rate will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)||||breaths per minute||Standard Error|Mean
2657496|NCT01605539|Secondary|Vital Signs - Heart Rate|"Heart rate (in beats/min) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Heart rate will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)||||beats per minute||Standard Error|Mean
2657497|NCT01605539|Secondary|The Positive and Negative Affect Schedule (PANAS) - Negative Affect Schedule (NAS) Data|"Questionnaires will be used to measure subjective responses. The Positive and Negative Affect Schedule will allow us to obtain positive and negative affect measures and observe their changes from baseline over the course of the cue-induced craving session. Scale: 0 (only slightly or not at all) - 5 (extremely). Total Score Range for Negative Affect Assessment (NAS): 10 (minimum) - 50 (maximum). Higher score reflects stronger negative affect.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)||||units on a scale||Standard Error|Mean
2657498|NCT01605539|Secondary|The Positive and Negative Affect Schedule (PANAS) - Positive Affect Schedule (PAS) Data|"Questionnaires will be used to measure subjective responses. The Positive and Negative Affect Schedule will allow us to obtain positive and negative affect measures and observe their changes from baseline over the course of the cue-induced craving session. Scale: 0 (only slightly or not at all) - 5 (extremely). Total Score Range for Positive Affect Assessment (PAS): 10 (minimum) - 50 (maximum). Higher score reflects stronger positive affect.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test session 1, 2, and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)||||units on a scale||Standard Error|Mean
2657499|NCT01605539|Secondary|Visual Analog Scale for Anxiety (VASA)|"Questionnaires will be used to measure subjective responses. Anxiety will be assessed using a visual analog scale for anxiety (VASA). Scale: 0 (not at all anxious) - 10 (extremely anxious).~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken for each variable. The same variables will be measured following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test visit I, II and IV: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)||||units on a scale||Standard Error|Mean
2657500|NCT01605539|Secondary|Vital Signs - Blood Pressure|"Blood pressure (mmHg) will be monitored throughout the time course of the study and changes from baseline will be studied across the various time points.~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. Blood pressure will be measured again following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test visits I, II and IV."|Test sessions 1,2,and 4: baseline 1, post cue (PC), baseline 2, post neutral cue (PN)||||mmHg||Standard Error|Mean
2657515|NCT01605435|Primary|Median Energy Intake|Median energy intake at breakfast, which was served 30 minutes post-placebo or ghrelin administration demonstrated at each dose level.|30 mins post-ghrelin or placebo|At the first visit all participants received s.c. placebo. The first two participants received 2 ,5, and 10ug/kg of ghrelin at visit 2, 3 and 4 consecutively. The final three participants received 5,7.5, and 10ug/kg of s.c. ghrelin at visits 2,3 and 4 consecutively.|||Kilocalories||Full Range|Median
2657516|NCT01605435|Primary|Treatment Emergent Adverse Events|Number and type of treatment emergent adverse events|30 days following the last administration of study treatment.|At the first visit all participants received s.c. placebo. The first two participants received 2 ,5, and 10ug/kg of ghrelin at visit 2,3 and 4 consecutively. The final three participants received 5,7.5, and 10ug/kg of s.c. ghrelin at visits 2,3 and 4 consecutively.|||Events|||Number
2657501|NCT01605539|Primary|Changes in Out-of-Clinic Craving (From Pre-Dose to Approximately 6 Hours Post-Dose for Test Visits I and II; and From Pre-Dose Test Visit I to Pre-Cue Test Visit IV) - Via the Heroin Craving Questionnaire (HCQ)|"Subjects will be asked to complete the short version of the HCQ on their own time at home and bring it with them when they return for their next visit. Upon arrival to the clinic, subjects will also complete an HCQ with the coordinator to assess daily baseline cravings. This questionnaire will help us assess changes in craving generated outside of the clinical laboratory session from test visit 1 through test visit 4. Scale: 1 (strongly disagree) - 7 (strongly agree). Total Score Range: 14 (less cravings) - 98 (more cravings).~** The baseline measure for this outcome will be measured at the beginning of test session I prior to the administration of CBD/Placebo. Test measures will be taken approximately 6 hours following each dose for test sessions I, II and III. The final measure will be taken at test session IV, at the beginning of the session."|Test I and II: Change from pre-dose to approx. 6 hours post-dose; Change from pre-dose test visit I to pre-cue test visit IV||||units on a scale||Standard Error|Mean
2657502|NCT01605539|Primary|Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - Via the Visual Analog Scale for Craving (VASC)|"The VASC will be administered to assess potential variations in the subjective craving effects associated with heroin. Following the administration of the investigational drug, craving induced in response to the cue sessions and neutral cue sessions in the clinic will be measured. In this way, changes in craving from baseline (pre-cue to post-cue and pre-neutral cue to post-neutral cue) within each test visit) will be measured and compared. Scale range: 0 (no craving) - 10 (extreme craving).~**For test visits I, II and IV, there will be two cue sessions at each test visit: a neutral cue video (PN) and a drug-related cue video (PC) will be shown in random order at each visit. Before the beginning of each cue session (PN or PC), baseline measures will be taken. The same questionnaires will be administered immediately following the neutral cue video and the drug-related cue video. Thus there will be two sets of baselines and two sets of post cue measurements per test visit for test"|VASC: test visits I, II and IV - baseline 1, post cue (PC), baseline 2, post neutral cue (PN)||||units on a scale||Standard Error|Mean
2657503|NCT01605461|Primary|Excretion of Total [14C]-Radioactivity in Faeces|Excretion of total [14C]-radioactivity in faeces|Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration|PK set|||Percentage of radioactive dose recovered||Geometric Coefficient of Variation|Geometric Mean
2657504|NCT01605461|Primary|Excretion of Total [14C]-Radioactivity in Urine|Excretion of total [14C]-radioactivity in urine|Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration|PK set|||Percentage of radioactive dose recovered||Geometric Coefficient of Variation|Geometric Mean
2657505|NCT01605461|Primary|Excretion Balance of Total [14C]-Radioactivity|Excretion balance of total [14C]-radioactivity (urine and faeces)|Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration|PK set|||Percentage of radioactive dose recovered||Geometric Coefficient of Variation|Geometric Mean
2657506|NCT01605461|Primary|t1/2 of [14C]-Radioactivity in Plasma|Terminal half life (T1/2) of [14C]-radioactivity in plasma|15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration|PK set|||hours||Geometric Coefficient of Variation|Geometric Mean
2657507|NCT01605461|Primary|Cmax of Plasma Deleobuvir|Maximum measured concentration (Cmax) of plasma deleobuvir|15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration|PK set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2657508|NCT01605461|Primary|AUC0-infinity of Plasma Deleobuvir|Area under the plasma deleobuvir concentration-time curve over the time interval from 0 h extrapolated to infinity (AUC0-infinity)|15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration|Pharmacokinetic analysis set (PK set) which included all subjects in the treated set who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2657509|NCT01605435|Primary|Free Fatty Acid Level|Free Fatty Acid levels (mEq/L) at 60 and 90 minutes after meal (90 and 120 minutes)|90 and 120 minutes after dosing|At the first visit all participants received s.c. placebo. The first two participants received 2 ,5, and 10ug/kg of ghrelin at visit 2,3 and 4 consecutively. The final three participants received 5,7.5, and 10ug/kg of s.c. ghrelin at visits 2,3 and 4 consecutively.|||mEq/L||Full Range|Median
2657510|NCT01605435|Primary|Insulin Level|Median fasting insulin levels at baseline and 90 minutes after dosing|0 and 90 minutes after dosing|At the first visit all participants received s.c. placebo. The first two participants received 2 ,5, and 10ug/kg of ghrelin at visit 2,3 and 4 consecutively. The final three participants received 5,7.5, and 10ug/kg of s.c. ghrelin at visits 2,3 and 4 consecutively.|||uIU/mL||Full Range|Median
2657511|NCT01605435|Primary|Glucose Levels|Median fasting and peak postprandial Glucose levels (60 or 90 minutes from dosing) at placebo and at each ghrelin dose.|0 minutes (baseline) and 60 or 90 minutes from dosing|At the first visit all participants received s.c. placebo. The first two participants received 2 ,5, and 10ug/kg of ghrelin at visit 2,3 and 4 consecutively. The final three participants received 5,7.5, and 10ug/kg of s.c. ghrelin at visits 2,3 and 4 consecutively.|||mg/dL||Full Range|Median
2657512|NCT01605435|Primary|Cortisol Level|Cortisol response to ghrelin or placebo - levels at 0, 60 and 120 minutes after dosing|0, 60 and 120 minutes after dosing|At the first visit all participants received s.c. placebo. The first two participants received 2 ,5, and 10ug/kg of ghrelin at visit 2,3 and 4 consecutively. The final three participants received 5,7.5, and 10ug/kg of s.c. ghrelin at visits 2,3 and 4 consecutively.|||mcg/dL||Full Range|Median
2657513|NCT01605435|Primary|Growth Hormone|median growth hormone peak 30 minutes after placebo/ghrelin.|30 minutes after ghrelin administration|At the first visit all participants received s.c. placebo. The first two participants received 2 ,5, and 10ug/kg of ghrelin at visit 2,3 and 4 consecutively. The final three participants received 5,7.5, and 10ug/kg of s.c. ghrelin at visits 2,3 and 4 consecutively.|||ng/mL||Full Range|Median
2657517|NCT01605396|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of analysis were censored at the date last known to be alive. OS was analyzed using the Kaplan-Meier method and median OS (95% confidence interval [CI]) in weeks was reported for each treatment arm. Per protocol, all participants (including participants who discontinued study treatment) were followed for survival until investigator notification to discontinue.|From Day 1 through last post-study efficacy follow-up (up to ~19 months)|All randomized participants.|||Weeks||95% Confidence Interval|Median
2657518|NCT01605396|Secondary|3. Percentage of Participants With Objective Response (Objective Response Rate [ORR]) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR).|ORR was defined as the percentage of participants whose best response was complete response (CR; disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or partial response (PR; at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR. ORR was reported for each treatment arm. Per protocol, participants remained on assigned treatment until disease progression. Participants who discontinued study treatment for reasons other than disease progression continued to be assessed by imaging until objective documentation of progression.|From Day 1 through last post-study efficacy follow-up (up to ~19 months)|All randomized participants.|||Percentage of Participants||95% Confidence Interval|Number
2657519|NCT01605396|Secondary|Percent Change From Baseline in Sum of Target Lesion Diameters at Week 16|The percent change from baseline to Week 16 in the sum of target lesion diameters as determined by anatomic imaging was defined as the line length (i.e., diameter) for each target lesion identified at baseline summed across all lesions at baseline, and separately at each post-baseline time point. The primary analysis was conducted using a constrained longitudinal data analysis (cLDA) method and target lesion measurements according to the BICR. Percent change from baseline in sum of target lesion diameters at Week 16 was reported for each treatment arm.|Baseline, Week 16|All randomized participants with available Week 16 target lesion measurements.|||percent change||Standard Deviation|Mean
2657520|NCT01605396|Primary|1. Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR)|PFS was defined as the time from randomization to progressive disease, or death, whichever occurs first. Response was assessed according to RECIST 1.1 by BICR. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% confidence interval [CI]) in weeks was reported for each treatment arm. Per protocol, participants remained on assigned treatment until disease progression. Participants who discontinued study treatment for reasons other than disease progression continued to be assessed by imaging until objective documentation of progression. All participants (including participants who discontinued study treatment) were followed for survival until investigator notification to discontinue.|From Day 1 through last post-study efficacy follow-up (up to ~19 months)|All randomized participants.|||Weeks||95% Confidence Interval|Median
2657521|NCT01605370|Primary|Change in Inappropriate Left Ventricular Mass (LVM)|LVM will be measured by echocardiography exam. LVM is inappropriate when observed LVM (oLVM) exceeds predicted LVM (pLVM) by more than 28%, that is, 100×(oLVM/pLVM) >128%.|baseline, 6 months|Data were not collected for the single participant, so no analysis was performed.||||||
2657522|NCT01605292|Other Pre-specified|Pain Score|Patient-reported wrist pain using a visual-analogue scale (0-10) 2-8 hours after the procedure, where 0 is no pain and 10 is severe pain.|2-8 hours after procedure||||units on a scale||Inter-Quartile Range|Median
2657523|NCT01605292|Post-Hoc|Failure of Radial Sheath Insertion With Original Randomized Technique||Immediate||||participants|||Number
2657524|NCT01605292|Post-Hoc|Crossover to Ultrasound Rescue Attempts After 5 Minutes|Patients randomized to palpation-guided access could have their procedure changed to ultrasound at operator discretion after 5 minutes of palpation-guided attempts.|5 minutes|Only patients randomized to palpation could potentially cross over to ultrasound technique.|||participants|||Number
2657525|NCT01605292|Other Pre-specified|Bleeding Complication|Any hematoma >2 cm or bleeding requiring intervention|After procedure (within 24 hours)||||participants|||Number
2657526|NCT01605292|Other Pre-specified|Difficult Access >= 5 Minutes|Access that requires >= 5 minutes from first attempt to sheath insertion|Immediate (within 30 minutes)||||participants|||Number
2657527|NCT01605292|Other Pre-specified|Difficult Access Procedures >= 5 Attempts|Difficult procedures were defined as either requiring >= 5 attempts|Immediately during procedure (within 30 min)||||participants|||Number
2657528|NCT01605292|Other Pre-specified|Radial Artery Spasm|Spasm defined and identified by the operator as any significant resistance or patient pain with catheter manipulation|Immediately during procedure (within 30 min)||||participants|||Number
2657529|NCT01605292|Secondary|First-pass Success Rate|Proportion of procedures achieving access on the first attempt|Immediate|Subgroup of patients with accurate number of attempts measured|||participants|||Number
2657530|NCT01605292|Secondary|Time to Sheath Insertion (Seconds)|Time from initiation of vascular access attempts to successful aspiration or flushing of the sheath. Time for lidocaine administration, palpation of pulse, or imaging is excluded.|Immediately during procedure (within 30 minutes)||||seconds||Standard Deviation|Mean
2657531|NCT01605292|Primary|Number of Attempts|Number of passes of the needle required to access the artery during the cardiac catheterization procedure. This is only assessed at the time of the procedure, i.e. during the first 30 minutes. This is to be reported as both total number of attempts and as a first pass success rate.|Immediately during procedure. (up to 30 minutes)|473 patients of 698 had number of attempts measured correctly by number of forward passes. This subgroup of the whole population was used for analysis of number of attempts.|||forward attempts||Standard Deviation|Mean
2657565|NCT01604772|Secondary|Overall Survival|Overall Survival is defined as the time from registration to death. The distribution of survival will be estimated using the method of Kaplan-MeierEstimated using Kaplan-Meier methodology.|Time of study entry to death due to any cause, assessed up to 3 years from registration|Two patients were not eligible for this endpoint.|||months||95% Confidence Interval|Median
2657532|NCT01605227|Other Pre-specified|Progression-free Survival (PFS)|The exploratory analysis of PFS is the time from randomization to date of first documented radiographic progression (bone and/or soft tissue) according to the investigator's assessment or death. PFS was defined per mRECIST 1.1 and included evaluation of measurable, nonmeasurable, target and nontarget lesions. A Kaplan-Meier analysis was performed to estimate the median duration.|Duration of PFS was defined as time from the date of randomization to earlier of date of radiographic progression (bone/andor soft tissue) according to the investigator's assessment or death, assessed for up to approximately 24 months|The Intent to Treat (ITT) population was used and include 1028 randomized subjects (682 cabozantinib, 346 prednisone) with a data cut off date of 07 July 2014.|||months||95% Confidence Interval|Median
2657533|NCT01605227|Secondary|Bone Scan Response (BSR)|BSR is defined as >=30% reduction in the bone scan lesion area (BSLA) compared with baseline. Confirmation of bone scan was not required for response or progression. Bone scans were evaluated by an independent radiology facility (IRF) for response.|BSR was measured at the end of Week 12 as determined by the IRF|Analysis was conducted on the ITT population (682 cabozantinib, 346 prednisone) for Bone Scan Response (BSR) at Week 12.|||percentage of participants||95% Confidence Interval|Number
2657534|NCT01605227|Primary|Overall Survival (OS)|The primary analysis of OS is defined as the time from randomization to death due to any cause. Participants that had not died or were permanently lost to follow-up were censored at the last known date alive. Median OS was calculated using Kaplan-Meier estimates. Analysis for OS was performed after 614 events had occurred.|OS was measured from the time of randomization until 614 events, approximately 24 months after study start|The Intent to Treat (ITT) population was used and included 1028 randomized subjects (682 cabozantinib, 346 prednisone).|||months||95% Confidence Interval|Median
2657535|NCT01605136|Secondary|Total Number Phototoxic Reactions Experienced by Participants|"The phototoxicity - phototoxic pain secondary endpoint has been divided into two secondary outcome measures.~The number of episodes was the endpoint. The days on which the participant experienced pain as a result of phototoxic reactions (caused by exposure to natural light) was recorded in a study diary. On each day such a reaction occurred, the participant scored the level of pain using an 11-point Likert pain scale, with minimum of 0 and maximum of 10. The 11-point Likert Pain scale with a value of 0 represents no pain and 10 represents worst imaginable pain.~The number of phototoxic reactions was determined by counting the number of episodes on which participants report a 11-point Likert scale score of 4 or more for one or more consecutive days."|Daily for 6 months||||episodes||Full Range|Median
2657536|NCT01605136|Secondary|Maximum Severity of Phototoxic Reaction Experienced by Participants|"The phototoxicity - phototoxic pain secondary endpoint has been divided into two secondary outcome measures.~The days on which the participant experienced pain as a result of phototoxic reactions (caused by exposure to natural light) was recorded in a study diary. On each day such a reaction occurred, the participant scored the level of pain using an 11-point Likert pain scale, with minimum of 0 and maximum of 10. The 11-point Likert pain scale with a value of 0 represents no pain and 10 represents worst imaginable pain.~The maximum severity of a phototoxic reaction was determined by the highest daily 11-point Likert scale score that occurred during that phototoxic reaction."|Daily for 6 months||||score on a scale||Full Range|Median
2657537|NCT01605136|Secondary|Photoprovocation|"A subset of subjects was photoprovoked on the dorsal surface of the hand (predilection place) and lower back and the minimum symptom dose (MSD) determined on Days 0, 30, 60, 90 and 120.~The amount of radiation required to provoke the first clinical symptom was recorded."|Day 0, Day 30, Day 60, Day 90 and Day 120.||||J/cm^2||Full Range|Median
2657538|NCT01605136|Secondary|Quality of Life Score|"The Quality of life of participant is measured using DLQI and EPP QoL. The Dermatology Life Quality Index (DLQI) is a simple practical measure for routine clinical use.~The DLQI ranges from 0 (no impact on life) to 30 (significant impact on life) . The Erthropoietic protoporphyria quality of life measure (EPP-QoL) scores range from 0 (worst imaginable QoL) to 100 (best possible QoL)."|Day 60, Day 120, and Day 180 or early termination.|The number of participants analyzed differs from the overall number of participants analyzed because the data was either incomplete and/or missing. Only data from those who completed the Quality of Life assessments are included at each time point.|||units on a scale||Full Range|Median
2657539|NCT01605136|Secondary|Sun Exposure|Duration of direct sunlight exposure between 10:00 and 18:00 hours during the study.|Daily for 6 months|Number of subjects (ITT population, from Patient Diary Card)|||hours||Full Range|Median
2657540|NCT01605136|Secondary|Combined Sun Exposure and Phototoxic Pain|"Time in direct sunlight exposure between 10:00 and 18:00 hours on days when no or mild pain was experienced (Likert scores of 0 to 3).~The pain score is measured by the 11-point Likert Pain scale with minimum of 0 and maximum of 10.~Likert Pain scale of 0 represents no pain and 10 represents worst imaginable pain."|Daily for 6 months|Number of subjects (ITT population, from Patient Diary Card)|||hours||Full Range|Median
2657541|NCT01605136|Primary|Duration of Direct Sunlight Exposure Between 10:00 and 18:00 Hours on Days When no Pain Was Experienced (Pain Score of 0).|"The amount of direct sunlight exposure between 10:00 and 18:00 hours on days when no pain was experienced (e.g.11-point Likert pain score of 0). Time was recorded in a patient diary using 15 minute time blocks.~The pain score is measured by the 11-point Likert Pain scale with minimum of 0 and maximum of 10.~Likert Pain scale of 0 represents no pain and 10 represents worst imaginable pain."|Daily for 6 months|Number of subjects (ITT population, from Patient Diary Card)|||hours||Full Range|Median
2657542|NCT01605019|Secondary|Evaluate the Use of CoSeal for Its Ability to Reduce Micro Emboli During the LVAD Implant Procedure and Prevent Tissue Adhesions Following the Implantation of a LVAD|"During the LVAD implant surgery, TEE and Transcranial Doppler will be conducted before and after the LVAD implant/CoSeal™ administration to detect possible micro emboli in the left ventricle (TEE) and in the intra-cranial circulation (TCD).~• Intra-operative evaluation of surgical adhesions during LVAD explantation/heart transplant."|Participants will be followed for duration of hospital stay, typically average of 1-4 weeks at time of LVAD surgery & again at time of heart transplant surgery|Analysis not completed - study terminated due to funding pulled by sponsor||||||
2657566|NCT01604772|Secondary|Median Progression Free Survival|Progression Free Survival is defined as the time from registration to the earliest date of documentation of disease progression or death. The distribution of time to progression will be estimated using the method of Kaplan-Meier.|Time of study entry to progression or death, up to 3 years after registration|Two patients were deemed ineligible and were not included in this endpoint.|||months||95% Confidence Interval|Median
2657543|NCT01605019|Primary|Number of Participants With Reduced Bleeding Following the Implantation of a LVAD|The Primary Objective of this prospective pilot study is to evaluate the use of CoSeal™ for its ability to reduce bleeding following the implantation of a LVAD. Total output amounts for each chest tube (CT) will be collected every 24 hours until all chest tubes are discontinued. Additionally, the total number of blood transfusions required during the hospitalization to implant the LVAD will be collected|Participants will be follwed for the duration of hospital stay for LVAD implant, typically an average of 1-4 weeks.|no analysis was performed on the 4 subjects enrolled in the study - they did not complete study.||||||
2657544|NCT01604941|Secondary|Number of Participants Classified as a Responder by Serum Ferritin|A responder was defined as a participant whose observed serum ferritin level at the measured time point was less than the baseline value. Serum ferritin levels were determined from serum biochemistry analyses.|8 and 16 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||participants|||Number
2657545|NCT01604941|Secondary|Number of Participants Classified as a Responder by R2* MRI Analysis of LIC Adjusted For Transfusional Iron Intake|A responder was defined as a participant whose observed liver iron concentration (LIC) at the measured time point was less than the baseline value. LIC was assessed by abdominal MRI with the R2* according to standard procedures (liver and pancreas), and the results were adjusted for transfusional iron intake. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants. For participants who had a blood transfusion on the MRI exam date, the blood transfusion done immediately prior to the MRI exam date was included in the calculation of daily transfusion intake.|12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||participants|||Number
2657546|NCT01604941|Secondary|Number of Participants Classified as a Responder by R2* MRI Analysis of LIC|A responder was defined as a participant whose observed liver iron concentration (LIC) at the measured time point was less than the baseline value. LIC was assessed by abdominal MRI with the R2* according to standard procedures (liver and pancreas). Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||participants|||Number
2657547|NCT01604941|Secondary|Number of Participants Classified as a Responder by FerriScan R2 MRI Analysis of LIC Adjusted For Transfusional Iron Intake|A responder was defined as a participant whose observed liver iron concentration (LIC) at the measured time point was less than the baseline value. LIC was assessed by abdominal MRI with the FerriScan R2 according to standard procedures, and the results were adjusted for transfusional iron intake. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants. For participants who had a blood transfusion on the MRI exam date, the blood transfusion done immediately prior to the MRI exam date was included in the calculation of daily transfusion intake.|12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||participants|||Number
2657548|NCT01604941|Secondary|Number of Participants Classified as a Responder by FerriScan R2 MRI Analysis of LIC|A responder was defined as a participant whose observed liver iron concentration (LIC) at the measured time point was less than the baseline value. LIC was assessed by abdominal MRI with the FerriScan R2 according to standard procedures. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||participants|||Number
2657549|NCT01604941|Primary|Change From Baseline in LIC Adjusted by Transfusional Iron Intake And Assessed by FerriScan R2 MRI|The efficacy of SPD602 was assessed by determining LIC and adjusting for transfusional iron intake. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. For participants who had a blood transfusion on the MRI exam date, the blood transfusion done immediately prior to the MRI exam date was included in the calculation of daily transfusion intake. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||mg Fe/g*dw||Standard Deviation|Mean
2657550|NCT01604941|Secondary|Change From Baseline in Serum Ferritin|Serum ferritin levels were determined from serum biochemistry analyses. A negative change from baseline indicates that serum ferritin decreased.|Baseline, 8 and 16 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||ng/mL||Standard Deviation|Mean
2657551|NCT01604941|Secondary|Change From Baseline in Cardiac T2* Relaxation Rate, an MRI Parameter Used to Estimate Cardiac Iron Load|The efficacy of SPD602 was assessed by estimating cardiac iron load. T2* data from cardiac MRI were collected by using standard procedures and used as an estimate of cardiac iron load. T2* is an MR relaxation parameter that is reported in milliseconds. Iron within a tissue decreases homogeneity of the magnetic field and shortens the T2* relaxation rate (Anderson, 2001). Low cardiac T2* values are associated with increased risk of heart failure (Kirk, 2009). A negative change from baseline in the T2* relaxation rate indicates that iron load increased. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||milliseconds||Standard Deviation|Mean
2657552|NCT01604941|Secondary|Change From Baseline in LIC Adjusted by Transfusional Iron Intake And Assessed by R2* MRI|The efficacy of SPD602 was assessed by determining LIC and adjusting for transfusional iron intake. Abdominal MRI data were collected by using R2* standard procedures (liver and pancreas) and used to determine LIC. A negative change from baseline indicates that LIC decreased. For participants who had a blood transfusion on the MRI exam date, the blood transfusion done immediately prior to the MRI exam date was included in the calculation of daily transfusion intake. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||mg Fe/g*dw||Standard Deviation|Mean
2657553|NCT01604941|Secondary|Change From Baseline in LIC as Assessed by R2* MRI|The efficacy of SPD602 was assessed by determining LIC. Abdominal MRI data were collected by using R2* standard procedures (liver and pancreas) and used to determine LIC. A negative change from baseline indicates that LIC decreased. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||mg Fe/g*dw||Standard Deviation|Mean
2657554|NCT01604941|Primary|Change From Baseline in Liver Iron Concentration (LIC) as Assessed by FerriScan R2 Magnetic Resonance Imaging (MRI)|The efficacy of SPD602 was assessed by determining LIC. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased. Early Termination was within the protocol defined visit date +/- 14 days window and was mapped to next scheduled MRI visit for 3 participants.|Baseline, 12 and 24 weeks|The Full Analysis Set, defined as all participants in the Safety Set who had at least 1 post-baseline primary efficacy assessment. The Safety Set was defined as all participants who had taken at least 1 BID dose of investigational product.|||mg Fe/g*dw||Standard Deviation|Mean
2657555|NCT01604850|Secondary|Percentage of Participants With Viral Relapse|"Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|End of treatment to posttreatment Week 24|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.|||participants|||Number
2657556|NCT01604850|Secondary|Percentage of Participants With Viral Breakthrough|"Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.~For the purposes of this efficacy analysis, assessments were made during active treatment (up to Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|Up to 16 weeks|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2657557|NCT01604850|Secondary|Percentage of Participants Achieving SVR24|"SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|Posttreatment Week 24|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2657558|NCT01604850|Secondary|Percentage of Participants Achieving SVR4|"SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|Posttreatment Week 4|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2657559|NCT01604850|Primary|Adverse Events Leading to Permanent Discontinuation of Study Drug|Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment.|Baseline to Week 16|The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.|||participants|||Number
2657560|NCT01604850|Primary|Percentage of Participants Achieving SVR12|"SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy.~For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm)."|Posttreatment Week 12|The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2657561|NCT01604785|Secondary|Emergency Department Length of Stay|Length of stay from administration of medication to Emergency Department discharge in minutes|Duration of stay in Emergency Department in Minutes||||Minutes||Full Range|Median
2657562|NCT01604785|Secondary|Rebound Headache at 24 Hour Follow-up Phone Call|Percentage of subjects reporting recurrence of headache with pain greater than at time of discharge from Emergency Department|24 hours|Percentage of participants|||Percentage of subjects reporting rebound|||Number
2657563|NCT01604785|Primary|Change in Self-Assessed Pain|Percent pain change after initial treatment using 10 point VAS scale|15 minutes after administration||||percentage change|||Number
2657564|NCT01604772|Secondary|Incidence of Toxicities of Akt Inhibitor MK-2206|Safety will be assessed in terms of the number of participants reporting grade 3 or higher adverse events as evaluated by Common Terminology Criteria for Adverse Events v4.0 (CTCAE).|Time to first treatment to up to 30 days after completion of treatment|All patients that started protocol treatment were included in this analysis.|||Participants|||Count of Participants
2658304|NCT01599585|Secondary|Beck Hopelessness Scale (BHS)|The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.|Baseline||||units on a scale||Standard Deviation|Mean
2657567|NCT01604772|Primary|Confirmed Response Rate (Complete Response + Partial Response) According to RECIST Version 1.1|"Confirmed response rate will be reported as the number of participants achieving either a complete response or partial response (using RECIST v1.1) divided by the number of evaluable participants. In order for a participant to be a confirmed objective responder, they must achieve a PR or CR on consecutive evaluations, at least 4 weeks apart.~Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers.~Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD."|Up to 32 weeks|Two patients were deemed ineligible for this endpoint due to eligibility criteria not being met. Therefore, this endpoint is reported using 14 eligible patients.|||percentage of patients||95% Confidence Interval|Number
2657568|NCT01604408|Secondary|Change From Baseline in Usual Gait Speed (uGS) at 4 Meters|Change from baseline to the 24-week endpoint in uGS is presented. Two attempts to walk a 4-meter distance were made. LS means were calculated using a MMRM with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline uGS as covariate.|Baseline to 24 weeks|All participants who received at least 1 dose of LY2495655 or placebo with evaluable uGS data.|||meters per second (m/s)||Standard Error|Least Squares Mean
2657569|NCT01604408|Secondary|Change From Baseline in Repeated Chair Stands (RCS) Time|Change from baseline to 24-week endpoint in RCS time is presented. In the RCS test, participants were asked to rise from a chair 5 times as fast as possible with their arms folded on their chest. Performance was measured in seconds, as the time from the initial seated position to the final standing position. LS means were calculated using an MMRM with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline RCS time as covariate.|Baseline to 24 weeks|All participants who received at least 1 dose of LY2495655 or placebo with evaluable RCS time data.|||seconds||Standard Error|Least Squares Mean
2657570|NCT01604408|Secondary|Change From Baseline in Stair Climbing (StC) Time|Change from baseline to the 24-week endpoint in StC time is presented. StC time was assessed by measuring the fastest time achieved to climb 4 steps on a 4-step staircase (the test was performed 2 times). LS means were calculated using a MMRM with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline StC score as covariate.|Baseline to 24 weeks|All participants who received at least 1 dose of LY2495655 or placebo with evaluable StC time data.|||seconds||Standard Error|Least Squares Mean
2657571|NCT01604408|Primary|Change From Baseline to 24 Week Endpoint in Appendicular Lean Body Mass (aLBM)|Change from baseline to 24-week endpoint in aLBM, as measured by dual energy x-ray absorptiometry (DEXA), is presented. Least squares (LS) means were calculated using a mixed model repeated measures (MMRM) with treatment, visit, and treatment-by-visit interaction as fixed effects and baseline aLBM as covariate.|Baseline to 24 weeks|All participants who received at least 1 dose of LY2495655 or placebo with evaluable aLBM data.|||kilograms (kg)||Standard Error|Least Squares Mean
2657572|NCT01604343|Secondary|Change From Baseline in EuroQol EQ-5D-3L Descriptive System|"The EQ-5D-3L Descriptive System comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received."|at Week 8, 16, 24, and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. The last observation at or prior to EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Units on a Scale||Standard Deviation|Mean
2657573|NCT01604343|Secondary|Change From Baseline in EuroQol Health State Visual Analogue Scale (EQ VAS)|The EuroQol Health State Visual Analogue Scale (EQ VAS) records the respondent's self-rated health on a vertical line, VAS where the endpoints are labeled as 0= 'Worst imaginable health state' and 100= 'Best imaginable health state'. The EQ VAS can be used as a quantitative measure of health outcome as judged by the individual respondents. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 8, 16, 24, 36 and 52|Full analysis set was defined as all randomized participants. Here 'N'(number of participants analyzed): Evaluable for this outcome measure. Last Observation Carried Forward (LOCF) method was used to impute missing values. The last observation at or prior to EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Units on a Scale||Standard Deviation|Mean
2657574|NCT01604343|Secondary|Change From Baseline in Total Scores of Work Limitations Questionnaire (WLQ) Week 8, 16, 24, 36 and 52|The Work Limitations Questionnaire (WLQ) was used to measure the impairment in work-related productivity, with reference to the previous two weeks. Each work-related question is scored from 0 to 4 and the total score ranges from 0-100, with lower scores signifying fewer limitations at work. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 8, 16, 24, 36 and 52|Full analysis set was defined as all randomized participants. Here 'N'(number of participants analyzed): Evaluable for this outcome measure. Last Observation Carried Forward (LOCF) method was used to impute missing values. The last observation at or prior to EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Units on a Scale||Standard Deviation|Mean
2657575|NCT01604343|Secondary|Percentage of Participants With Greater Than or Equal to 4-Point Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 8, 16, 24, 36 and 52|The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The questionnaire consists of 13 questions that assess a participant's level of fatigue and tiredness over the last 7 days. Each question is graded on a 5-point scale (0 - 4); and accordingly, the total FACIT-Fatigue scores can range from 0 to 52, with lower score reflecting more fatigue and higher scores reflecting less fatigue. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 8, 16, 24, 36 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. The last observation at or prior to EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Percentage of Participants|||Number
2657576|NCT01604343|Secondary|Change From Baseline in Physical and Mental Component Summary Scores of 36-Item Short Form Health Survey (SF-36) at Weeks 24 and 52|SF-36 questionnaire is health related quality of life (QOL) instrument with 36 questions with 8 multi-item scales (evaluated limitations in): physical functioning due to health problems; usual role activities due to physical health problems; Bodily pain; General mental health (psychological distress and well-being); usual role activities due to personal or emotional problems; social functioning due to physical or mental health problems; Vitality (energy and fatigue); General health perception. Each 8 scales scored from 0 to 100 with higher scores= better health. Based on scale scores, summary scores, physical component score (PCS) and mental component score (MCS) will be derived. Scoring is derived based on algorithm developed in software provided by developer. Summary MCS and PCS score is also scaled from 0 to 100 with higher scores= better health. Participants were analyzed according to randomized treatment groups they were assigned regardless of treatments they actually received.|Baseline, Week 24 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. The last observation at or prior to EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Units on a Scale||Standard Deviation|Mean
2657577|NCT01604343|Secondary|Change From Baseline in the Duration of Morning Stiffness Through Week 52|Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). Negative values for this outcome measure represent improvement, i.e. shortening of duration of morning stiffness. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set was defined as all randomized participants. Here 'N'(number of participants analyzed): Evaluable for this outcome measure. Last Observation Carried Forward (LOCF) method was used to impute missing values. The last observation at or prior to EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Minutes||Standard Deviation|Mean
2657578|NCT01604343|Secondary|Change From Baseline in Serum C-reactive Protein (CRP) Levels Through Week 52|Serum CRP is a marker of systemic inflammation. A negative change from baseline in CRP represents improvement. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. The last observation at or prior to EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Milligram per Deciliter||Standard Deviation|Mean
2657579|NCT01604343|Secondary|Change From Baseline in Van Der Heijde Modified Sharpe Score (vdH-S Score) by Reader at Weeks 24 and 52|vdH-S score measures structural damage progression as sum of joint erosion(JE) and joint space narrowing(JSN) scores(S).JE is summary of erosion severity in 32 of hands(H) and 12 of feet(F) joints, scored as per surface area- from 0 (no erosion) to 5 (complete(CM) collapse of bone). Maximum (MAX) JES for H-160 (32*5) and MAX JES for F- 120 (12*10 [5*2 sides of foot]). MAX JES is 280 whereas JSN is summary of severity of 30 of H and 12 of F joints, scored to subluxation from 0(normal) to 4(bony ankylosis or CM luxation). MAX JSNS for H-120(30*4), and MAX JSS for F-48(12*4). MAX JSNS is 168.Thus MAX JES-280 combined with MAX JSNS-168 gives worst possible vdH-SS (i.e., JE score + JSN score) of 448. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Weeks 24 and 52|Efficacy full analysis set (radiographic endpoints) had randomized participants received at least 1 (partial/complete) dose of study drug with non-missing baseline vdH-S score. It was based on imputed value by EE Rules: set scores after EE missing for placebo arm; and then missing data rules in all treatment arms using linear extrapolation method.|||Units on a Scale||Standard Deviation|Mean
2657580|NCT01604343|Secondary|Percentage of Participants With a Change of Less Than or Equal to 0 From Baseline in Van Der Heijde Modified Sharpe (vdH-S) Score at Weeks 24 and 52|vdH-S score measures structural damage progression as sum of joint erosion(JE) and joint space narrowing(JSN) scores(S).JE is summary of erosion severity in 32 of hands(H) and 12 of feet(F) joints, scored as per surface area- from 0 (no erosion) to 5 (complete(CM) collapse of bone). Maximum (MAX) JES for H-160 (32*5) and MAX JES for F- 120 (12*10 [5*2 sides of foot]). MAX JES is 280 whereas JSN is summary of severity of 30 of H and 12 of F joints, scored to subluxation from 0(normal) to 4(bony ankylosis or CM luxation). MAX JSNS for H-120(30*4), and MAX JSS for F-48(12*4). MAX JSNS is 168.Thus MAX JES-280 combined with MAX JSNS-168 gives worst possible vdH-SS of (i.e., erosion score + JSN score) 448. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 24 and 52|Efficacy full analysis set (radiographic endpoints) had randomized participants received at least 1 (partial/complete) dose of study drug with non-missing baseline vdH-S score. It was based on imputed value by EE Rules: set scores after EE missing for placebo arm; and then missing data rules in all treatment arms using linear extrapolation method.|||Percentage of Participants|||Number
2657586|NCT01604343|Secondary|Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Through Week 52|HAQ-DI response was defined as change of less than -0.22 from baseline in HAQ-DI score. The HAQ-DI score is an evaluation of the functional status for a participant. The 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. Last Observation at or prior EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Percentage of Participants|||Number
2657581|NCT01604343|Secondary|Percentage of Participants With Change From Baseline in Van Der Heijde Modified Sharpe Score (vdH-S Score) Greater Than Smallest Detectable Change (SDC) at Weeks 24 and 52|vdH-S score measures structural damage progression as sum of joint erosion(JE) and joint space narrowing(JSN) scores(S). JE is summary of erosion severity in 32 of hand and 12 of feet joints, scored according to the surface area, from 0 (no erosion) to 5 (complete collapse of bone) whereas the JSN is summary of severity of 30 of hand and 12 of feet joints, scored according to the subluxation from 0 (normal) to 4 (bony ankylosis or complete luxation). The SDC is smallest change in score that is considered to be assessed correctly based on limits of agreement (that is., above the measurement error). The SDC for change from baseline in vdH-S Score is determined as: SDC=1.96 * SD / (root 2 * root k), where SD is the standard deviation of the difference between 2 readers in change from baseline in vdH-S score; k is the number of readers. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Weeks 24 and 52|Efficacy full analysis set (radiographic endpoints) had randomized participants received at least 1 (partial/complete) dose of study drug with non-missing baseline vdH-S score. It was based on imputed value by EE Rules: set scores after EE missing for placebo arm; and then missing data rules in all treatment arms using linear extrapolation method.|||Percentage of Participants|||Number
2657582|NCT01604343|Secondary|Change From Baseline in Van Der Heijde-modified Sharpe (vdH-S) Sub-score by Region Hand or Feet and Type Erosion or JSN at Week 24 and 52|vdH-S score measures structural damage progression as sum of joint erosion(JE) and joint space narrowing(JSN) scores(S).JE is summary of erosion severity in 32 of hands(H) and 12 of feet(F) joints, scored as per surface area- from 0 (no erosion) to 5 (complete(CM) collapse of bone). Maximum (MAX) JES for H-160 (32*5) and MAX JES for F- 120 (12*10 [5*2 sides of foot]). MAX JES is 280 whereas JSN is summary of severity of 30 of H and 12 of F joints, scored to subluxation from 0(normal) to 4(bony ankylosis or CM luxation). MAX JSNS for H-120(30*4), and MAX JSS for F-48(12*4). MAX JSNS is 168.Thus MAX JES-280 combined with MAX JSNS-168 gives worst possible vdH-SS (i.e., erosion score + JSN score) of 448. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 24 and 52|Efficacy full analysis set (radiographic endpoints) had randomized participants received at least 1 (partial/complete) dose of study drug with non-missing baseline vdH-S score. It was based on imputed value by EE Rules: set scores after EE missing for placebo arm; and then missing data rules in all treatment arms using linear extrapolation method.|||Units on a Scale||Standard Deviation|Mean
2657583|NCT01604343|Secondary|Change From Baseline in Van Der Heijde-modified Sharpe (vdH-S) Sub-score by Type of Damage (Erosion or JSN) at Week 24 and 52|vdH-S score measures structural damage progression as sum of joint erosion(JE) and joint space narrowing(JSN) scores(S).JE is summary of erosion severity in 32 of hands(H) and 12 of feet(F) joints, scored as per surface area- from 0 (no erosion) to 5 (complete(CM) collapse of bone). Maximum (MAX) JES for H-160 (32*5) and MAX JES for F- 120 (12*10 [5*2 sides of foot]). MAX JES is 280 whereas JSN is summary of severity of 30 of H and 12 of F joints, scored to subluxation from 0(normal) to 4(bony ankylosis or CM luxation). MAX JSNS for H-120(30*4), and MAX JSS for F-48(12*4). MAX JSNS is 168.Thus MAX JES-280 combined with MAX JSNS-168 gives worst possible vdH-SS (i.e., JE score + JSN score) of 448. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 24 and 52|Efficacy full analysis set (radiographic endpoints) had randomized participants received at least 1 (partial/complete) dose of study drug with non-missing baseline vdH-S score. It was based on imputed value by EE Rules: set scores after EE missing for placebo arm; and then missing data rules in all treatment arms using linear extrapolation method.|||Units on a Scale||Standard Deviation|Mean
2657584|NCT01604343|Secondary|Change From Baseline in Van Der Heijde-modified Sharpe (vdH-S) Score at Week 24|vdH-S score is defined as a measurement of progression in structural damage. It is the sum of joint erosion (32 joints of the hands and 12 joints of the feet) score and joint space narrowing (JSN) (30 joints of the hands and 12 joints of the feet) score. The joint erosion assessment is scored according to the surface area involved, from 0 to 5, with 0 indicating no erosion and 5 indicating complete collapse of bone whereas the JSN assessment including subluxation, is scored from 0 (normal) to 4 (bony ankylosis or complete luxation). The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 24|Efficacy full analysis set (radiographic endpoints) had randomized participants received at least 1 (partial/complete) dose of study drug with non-missing baseline vdH-S score. It was based on imputed value by EE Rules: set scores after EE missing for placebo arm; and then missing data rules in all treatment arms using linear extrapolation method.|||Units on a Scale||Standard Deviation|Mean
2657585|NCT01604343|Secondary|Percentage of Participants With Health Assessment Questionnaire-Disability Index (HAQ-DI) Score of Less Than or Equal to 0.5|HAQ-DI score is an evaluation of the functional status for a participant. The 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. Last Observation at or prior EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Percentage of Participants|||Number
2657615|NCT01604291|Secondary|Percentage of Participants With End of Treatment Response (EoT)|End-of-Treatment (EoT) response was defined as HCV-RNA <50 IU/mL by the end of treatment.|Week 24|mTRT population: participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; participants' treatment documentation was sufficient for assignment to treatment groups. Number of participants analyzed: participants evaluated for this outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
2657587|NCT01604343|Secondary|Area Under the Curve (AUC) of Change From Baseline in HAQ-DI Score From Week 0 Through Week 24 and From Week 0 Through Week 52|HAQ-DI has 20-question in 8 functional areas: dressing, arising, eating, walking, hygiene, reaching, gripping, and daily living activities, scored from 0=no difficulty to 3=inability to perform task in that area. Overall score computed as sum of domain score divided by number of domains answered. Total possible score range 0= least difficulty to 3= extreme difficulty. AUC of change from baseline in HAQ-DI score is AUC of change from baseline in HAQ-DI score versus time. AUC was calculated based on measurement (observed HAQ-DI score change from baseline) at scheduled visits using trapezoidal rule.Functional status was determined as cumulative measure of HAQ-DI over 1 year by using AUC of change from baseline in HAQ-DI score through week 52. Decreases in AUC of change from baseline in HAQ-DI means greater average improvement in physical function over time. Participants analyzed according to randomized treatment groups they were assigned, regardless of treatments they actually received.|Week 0 Through Week 24 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. Last Observation at or prior EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Units on a Scale*Day||Standard Deviation|Mean
2657588|NCT01604343|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Through Week 52|The Health Assessment Questionnaire-Disability Index (HAQ-DI) score is an evaluation of the functional status for a participant. The 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Negative change reflects an improvement and a positive change reflects a worsening. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 2, 4, 6, 8, 12, 16, 18, 20, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. Last Observation at or prior EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Units on a Scale||Standard Deviation|Mean
2657589|NCT01604343|Secondary|Percentage of Participants With Boolean-based American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 52|A participant was considered as having achieved the Boolean-based American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) remission at a visit if all of the following 4 criteria were met at that visit: Tender joint count (68 joints) less than or equal to (<=) 1; Swollen joint count (66 joints) <=1; CRP <=1 milligram per deciliter (mg/dL); Patient's Global Assessment of Disease Activity <=1 on a 0 (very well) to 10 (very poor) VAS. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Participants were set to not achieving Boolean-based remission after meeting EE, LE or TF criteria (whichever is earliest) or if having data missing.|||Percentage of Participants|||Number
2657590|NCT01604343|Secondary|Percentage of Participants With Simplified Disease Activity Index Based (SDAI-based) American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission Through Week 52|Participant having SDAI-based ACR/EULAR remission at a visit if SDAI score is of <= 3.3. SDAI derived by combining 5 disease assessments: tender joint (28), swollen joint (28) counts, participants global assessment of disease activity using VAS (scale ranges from 0 to 10 [0 =very well to 10 = very poor]), physicians global assessment of disease activity using VAS (scale ranges from 0 to 10 [0=no arthritis to 10=extremely active arthritis]) and CRP. 28 joints evaluated for swelling and tenderness are same set of 28 joints used in DAS28 includes shoulder, elbow, wrist, MCP1, MCP2, MCP3, MCP4, MCP5, PIP1, PIP2, PIP3, PIP4, PIP5 joints of upper right and left extremities and knee joints of lower right and left extremities. Change from baseline in SDAI score measures change in disease activity, where negative change= improvement and positive change= worsening. Participants were analyzed according to randomized treatment groups they were assigned regardless of treatments actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Participants were set to not achieving SDAI-based remission after meeting EE, LE or TF criteria (whichever is earliest) or if having data missing.|||Percentage of Participants|||Number
2657591|NCT01604343|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score Through Week 52|The CDAI score is a derived score of 4 components: tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, and physician's global assessments of disease activity. The total score ranges from 0 to 76 with a lower score indicating less disease activity. A negative change in CDAI score indicates an improvement in disease activity and a positive change in score indicates a worsening of disease activity. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. Last Observation at or prior EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Units on a Scale||Standard Deviation|Mean
2657592|NCT01604343|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score Through Week 52|The SDAI score is a derived score combining tender joints (28 joints), swollen joints (28 joints), patient's global assessment of disease activity, physician's global assessments of disease activity, and CRP. The total score range is from 0 to 86 with a lower score indicating less disease activity. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. Last Observation at or prior EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Units on a Scale||Standard Deviation|Mean
2657593|NCT01604343|Secondary|Percentage of Participants With Disease Activity Index Score 28 (DAS28) (C-reactive Protein (CRP) Remission Through Week 52|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. The Disease Activity Index Score 28 (DAS28) C-reactive protein (CRP) remission is defined as a DAS28 (CRP) value of less than 2.6 at a visit. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Participants were set to not achieving DAS28 remission after meeting EE, LE or TF criteria (whichever is earliest) or if having data missing.|||Percentage of Participants|||Number
2657594|NCT01604343|Secondary|Change From Baseline in Disease Activity Index Score 28 (DAS28) C-reactive Protein (CRP) Through Week 52|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. A negative change from baseline in DAS28 (CRP) (that is, a decrease from baseline) indicates improvement from baseline. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. Last Observation at or prior EE/LE was used to replace the data after EE/LE for participants who met EE/LE criteria.|||Units on a Scale||Standard Deviation|Mean
2657595|NCT01604343|Secondary|Percentage of Participants With Disease Activity Index Score 28 (DAS28) C-reactive Protein (CRP) Response Through Week 52|DAS28 based on C-Reactive Protein (CRP), a statistically derived index combining tender joints (28), swollen joints (28), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both upper right extremity and upper left extremity as well as knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Good responders: improvement from baseline greater than (>) 1.2 with DAS28 less than or equal to (<=) 3.2; moderate responders: improvement from baseline >1.2 with DAS28 >3.2 to <=5.1 or improvement from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: improvement from baseline <=0.6 or improvement from baseline >0.6 and <=1.2 with DAS28 >5.1. Participants were analyzed according to randomized treatment groups they were assigned to, regardless of treatments they actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set included all randomized participants. Participants were set to non-responders after meeting EE, LE or TF criteria (whichever is earliest) or if having data missing.|||Percentage of Participants|||Number
2657596|NCT01604343|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 90 Response Through Week 52|An ACR 90 response is defined as >= 90 percent (%) improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 90% improvement in 3 of the following 5 assessments: Participant's assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant's assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and Serum CRP. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set was defined as all randomized participants. Participants were set to non-responders after meeting EE, LE or TF criteria (whichever is earliest) or if having data missing.|||Percentage of Participants|||Number
2657597|NCT01604343|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 70 Response Through Week 52|An ACR 70 response is defined as >= 70 % improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 70% improvement in 3 of the following 5 assessments: Participant's assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant's assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and Serum CRP. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Full analysis set was defined as all randomized participants. Participants were set to non-responders after meeting EE, LE or TF criteria (whichever is earliest) or if having data missing.|||Percentage of Participants|||Number
2657616|NCT01604291|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|Complete early virologic response (cEVR) was defined as HCV-RNA <50 IU/mL by Week 12|Week 12|mTRT population: participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; participants' treatment documentation was sufficient for assignment to treatment groups. Number of participants analyzed: participants evaluated for this outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
2657761|NCT01603368|Secondary|Length Gain (SD)|In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.|At 14th day of life||||change in standard deviations||Standard Deviation|Mean
2657598|NCT01604343|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 50 Response|An ACR 50 response is defined as >= 50 % improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: Participant's assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant's assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and Serum CRP. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 2, 4, 6, 8, 12, 16, 18, 20, 28, 32, 36, 40, 44, 48 and 52|Full analysis set was defined as all randomized participants. Participants were set to non-responders after meeting EE, LE or TF criteria (whichever is earliest) or if having data missing.|||Percentage of Participants|||Number
2657599|NCT01604343|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response Through Week 52|An ACR 20 response is defined as >= 20 % improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 20% improvement in 3 of the following 5 assessments: Participant's assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant's assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and Serum CRP. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 2, 4, 6, 8, 12, 18, 20, 24, 28, 32, 36, 40, 44, 48, and 52|Full analysis set included all randomized participants. Participants were set to non-responders after meeting EE, LE or TF criteria (whichever is earliest) or if having data missing.|||Percentage of Participants|||Number
2657600|NCT01604343|Secondary|Percentage of Participants With Major Clinical Response (MCR) at Week 52|MCR- participant achieving ACR 70 response for 6 continuous months (24 weeks) in the study period (i.e., through Week 52). An ACR 70 response is defined as >= 70% improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 70% improvement in 3 of the following 5 assessments Participant's assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant's global assessment of disease activity by using VAS (scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician's global assessment of disease activity using VAS (scale ranges from 0 to 10, [0=no arthritis to 10=extremely active arthritis]), Participant's assessment of physical function as measured by HAQ-DI (scale ranges from 0= no difficulty, to 3= inability to perform a task in that area) and Serum CRP. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 52|Full analysis set was defined as all randomized participants. Participants were set to non-responders if meeting EE, LE or TF criteria prior to week 52 or having data missing.|||Percentage of Participants|||Number
2657601|NCT01604343|Secondary|Percentage of Participants With Disease Activity Index Score 28 (DAS28) (C-reactive Protein (CRP) Remission at Week 24|The DAS28 based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. The Disease Activity Index Score 28 (DAS28) C-reactive protein (CRP) remission is defined as a DAS28 (CRP) value of less than 2.6 at a visit. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 24|Full analysis set included all randomized participants. Participants were set to not achieving DAS28 remission if meeting EE or TF criteria prior to week 24 or having data missing.|||Percentage of Participants|||Number
2657602|NCT01604343|Secondary|Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 24|An American College of Rheumatology (ACR) 50 response is defined as >= 50 % improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: Participant's assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant's assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and Serum CRP. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Week 24|Full analysis set included all randomized participants. Participants were set to non-responders if meeting EE or TF criteria prior to week 24 or having data missing.|||Percentage of Participants|||Number
2657603|NCT01604343|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24|The Health Assessment Questionnaire-Disability Index (HAQ-DI) score is an evaluation of the functional status for a participant. The 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received.|Baseline, Week 24|Full analysis set included all randomized participants. Last Observation Carried Forward (LOCF) method was used to impute missing values. Last Observation at or prior EE was used to replace the data after EE for participants who met EE criteria.|||Units on Scale||Standard Deviation|Mean
2657604|NCT01604343|Primary|Change From Baseline in Van Der Heijde-modified Sharpe (vdH-S) Score at Week 52|The van der Heijde-modified Sharpe (vdH-S) score is defined as a measurement of progression in structural damage. It is the sum of joint erosion (32 joints of the hands and 12 joints of the feet) score and joint space narrowing (JSN) (30 joints of the hands and 12 joints of the feet) score. The joint erosion assessment is scored according to the surface area involved, from 0 to 5, with 0 indicating no erosion and 5 indicating complete collapse of bone whereas the JSN assessment including subluxation, is scored from 0 (normal) to 4 (bony ankylosis or complete luxation). The total score ranges from 0 (best) to 448 (worst) with higher scores indicating more joint damage. Participants were analyzed according to the randomized treatment groups they were assigned to, regardless of the treatments they actually received. Here, EE= early escape.|Baseline, Week 52|Efficacy full analysis set (radiographic endpoints) had randomized participants received at least 1 (partial/complete) dose of study drug with non-missing baseline vdH-S score. It was based on imputed value by EE Rules: set scores after EE missing for placebo arm; and then missing data rules in all treatment arms using linear extrapolation method.|||Units on a Scale||Standard Deviation|Mean
2657605|NCT01604343|Primary|Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 16|ACR 20 response is greater than or equal to (>=) 20 percent (%) improvement in both tender joint count (68) and swollen joint count (66) and >= 20% improvement in 3 of following 5 assessments:Participant's assessment of pain using visual analog scale (VAS) (0-10 scale, 0=no pain and 10=worst possible pain),Participant's global assessment of disease activity by using VAS (scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician's global assessment of disease activity using VAS (scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI) (scale ranges from 0= no difficulty to 3= inability to perform a task in that area), and Serum C-reactive protein (CRP). Participants were analyzed according to randomized treatment groups they were assigned, regardless of treatments they actually received. Here, TF= treatment failure.|Week 16|Full analysis set included all randomized participants. Participants were set to non-responders if meeting TF criteria prior to week 16 or having data missing.|||Percentage of Participants|||Number
2657606|NCT01604291|Secondary|Percentage of Participants Who Had SVR at Week 24 With Dose Modifications|Participants with dose modifications who had achieved SVR at Week 24 were reported. Data was collected for all participants who had dose modification of Peginterferon alfa-2a, Ribavirin or Telaprevir/boceprevir in any of the treatment regimen during the study.|Week 24|mTRT population: includes all participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; the participants' treatment documentation was sufficient for assignment to treatment groups.|||percentage of participants|||Number
2657607|NCT01604291|Secondary|Percentage of Participants With Treatment Regimen for HCV Treatment Induced Anemia||Week 48|Safety Population. Included only participants who had received at least one dose of peginterferon alfa-2a plus ribavirin or peginterferon alfa-2a plus ribavirin plus telaprevir/boceprevir and had at least one post-baseline safety assessment.|||Percentage of Participants|||Number
2657608|NCT01604291|Secondary|Mean Value of Hemoglobin in Participants With Treatment-Induced Anemia||Week 48|Safety Population. Included only participants who had received at least one dose of peginterferon alfa-2a plus ribavirin or peginterferon alfa-2a plus ribavirin plus telaprevir/boceprevir and had at least one post-baseline safety assessment.|||Grams per Deciliter (g/dl)||Standard Deviation|Mean
2657609|NCT01604291|Secondary|Percentage of Participants With Adverse Events (AEs)|"Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.~Safety analysis included 2 additional participants in arm 'Peginterferon Alfa-2a + Ribavirin + Telaprevir'. The safety parameters were analyzed by the treatment actually received by the participants."|Week 48|Safety Population. Included only participants who had received at least one dose of peginterferon alfa-2a plus ribavirin or peginterferon alfa-2a plus ribavirin plus telaprevir/boceprevir and had at least one post-baseline safety assessment.|||Percentage of Participants|||Number
2657610|NCT01604291|Secondary|Time to First Dose Modification of Telaprevir/Boceprevir||Week 48|mTRT population:participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy;had received 1 of study's triple combination therapies;participants' treatment documentation was sufficient for assignment to treatment groups.Number of participants analyzed:participants evaluated for this outcome measure.|||Days||Standard Deviation|Mean
2657611|NCT01604291|Secondary|Time to First Dose Modification of Ribavirin||Week 48|mTRT population: participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; participants' treatment documentation was sufficient for assignment to treatment groups. Number of participants analyzed: participants evaluated for this outcome measure.|||Days||Standard Deviation|Mean
2657612|NCT01604291|Secondary|Time to First Dose Modification of Peginterferon Alfa-2a||Week 48|mTRT population: participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; participants' treatment documentation was sufficient for assignment to treatment groups. Number of participants analyzed: participants evaluated for this outcome measure.|||Days||Standard Deviation|Mean
2657613|NCT01604291|Secondary|Treatment Duration|The average amount of time a treatment was prescribed to participants.|Week 48|All Enrolled Participants|||Weeks||Standard Deviation|Mean
2657614|NCT01604291|Secondary|Percentage of Participants With Virologic Relapse|Virologic relapse was defined as detectable HCV-RNA during the treatment-free follow-up period in participants with HCV-RNA <50 IU/mL at EoT.|Week 72|mTRT population: participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; participants' treatment documentation was sufficient for assignment to treatment groups. Number of participants analyzed: participants evaluated for this outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
2657919|NCT01602315|Secondary|For Phase II: Notable Abnormal Vital Signs by Treatment|Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm 1, 2 and 2B.|approximately 6 months|Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.|||Participants|||Number
2657617|NCT01604291|Secondary|Percentage of Participants With Extended RVR|"Extended RVR was defined as HCV-RNA <50 IU/mL at weeks 4 and 12 for participants treated with telaprevir; or at weeks 8 & 24 for participants treated with boceprevir.~The assessment was performed in participants who received triple therapy in treatment arms 'Peginterferon Alfa-2a + Ribavirin +Telaprevir' and 'Peginterferon Alfa-2a + Ribavirin + Boceprevir'."|Week 4 and 12 for telaprevir group; Week 8 and 24 for boceprevir group|mTRT population:participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy;had received one of study's triple combination therapies;participants' treatment documentation was sufficient for assignment to treatment groups.Number of participants analyzed:participants evaluated for this outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
2657618|NCT01604291|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) at Week 4|RVR was defined as HCV-RNA <50 IU/mL by Week 4|Week 4|mTRT population: participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; participants' treatment documentation was sufficient for assignment to treatment groups. Number of participants analyzed: participants evaluated for this outcome measure.|||Percentage of Participants||95% Confidence Interval|Number
2657619|NCT01604291|Secondary|Number of Participants With SVR at Week 24 According to the Demographic Characteristics|The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels < 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion. Number of participants analysed signifies participants who were evaluated for outcome measure. Data for this outcome measure was not summarized for each arm. Hence, data is reported for all participants.|Week 24|Participants who treated for chronic hepatitis C(CHC)with either dual therapy (peginterferon alfa-2a and ribavirin)or triple therapy(peginterferon alfa-2a and ribavirin and telaprevir/boceprevir)for up to 24 weeks thereafter in line with local prescribing information at time of study and for whom demographic baseline characteristics were available.|||Participants|||Count of Participants
2657620|NCT01604291|Secondary|Comparison of SVR at Week 24|SVR at Week 24 is compared by treatment group, type of infection, prior treatments and genotype.|Week 24|Modified All Treated (mTRT) Population: includes all participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; the participants' treatment documentation was sufficient for assignment to treatment groups.|||Percentage of Participants||95% Confidence Interval|Number
2657621|NCT01604291|Primary|Percentage of Participants With Sustained Viral Response (SVR) at Week 24|The overall SVR-24 rate was defined as percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels < 50 International Units per MilliLiter (IU/mL) (as measured by Polymerase Chain Reaction (PCR)) at 24 weeks post treatment completion.|Week 24|Modified All Treated (mTRT) Population: includes all participants who had an HCV-RNA result ≥50 IU/mL at their last measurement prior to commencing CHC therapy; had received one of the study's combination therapies; the participants' treatment documentation was sufficient for assignment to treatment groups.|||Percentage of Participants||95% Confidence Interval|Number
2657622|NCT01604278|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|All study emergent adverse events including Chronic Obstructive Pulmonary Disease exacerbations were monitored from screening through the end of study.|12 weeks|Safety Set: The safety set included all patients who received at least one dose of study drug whether or not they were randomized.|||Number of participants|||Number
2657623|NCT01604278|Secondary|Change From Baseline in Mean Daily Total and Individual Symptom Scores|The symptoms (respiratory, cough, wheeze, sputum color, sputum production, breathlessness, sore throat, nasal discharge or congestion, and fever) for the whole active treatment period was analyzed using a mixed model, which contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline symptom score, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilators as covariates and center nested in region as a random effect. Each symptom was scored as 0, 1, 2 or 3 where the description for each score varied. For each of the symptoms, the range of scores from 0 to 3 represented an increase in symptoms where 0 represented little to no symptom and 3 represented severe or worst symptom. The total symptom score, which is the sum of the individual scores, ranged from 0 (best possible outcome) to 27 (worst possible outcome).|Baseline, 12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Score||Standard Error|Least Squares Mean
2657624|NCT01604278|Secondary|Transitional Dyspnea Index (TDI) Focal Score|Dyspnea was measured at baseline using the Baseline Dyspnea Index (BDI) and during treatment using the Transitional Dyspnea Index (TDI). Analysis was done via mixed model. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort. BDI domains were rated from 0 (severe) to 4 (unimpaired) and rates summed for baseline focal score ranged from 0 to 12; lower scores mean worse severity. TDI domains were rated from -3 (major deterioration) to 3 (major improvement) and rates summed for transition focal score ranged from -9 to 9; negative scores indicate deterioration. A TDI focal score of 1 is considered a minimal clinically important difference.|baseline, 12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Score||Standard Error|Least Squares Mean
2657625|NCT01604278|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication|The number of puffs of rescue medication taken in the previous 12 hours was recorded in the patient diary in the morning and evening. The total number of puffs of rescue medication per day over the whole active treatment period was calculated and divided by the total number of days with non-missing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient. If the number of puffs was missing for part of the day (either morning or evening), then a half day was used in the denominator.|Baseline, 12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Number of puffs||Standard Error|Least Squares Mean
2658072|NCT01601132|Primary|Apparent Total Volume of Distribution (Vd/F) of Theophylline|Apparent total volume of distribution after oral administration, calculated as Dose /(AUC0-∞) * Apparent first-order elimination rate constant [Kel])|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|PK population|||liters||Standard Deviation|Mean
2657626|NCT01604278|Secondary|Inspiratory Capacity (IC) at Individual Time-points|Inspiratory Capacity (IC) was measured at 20 min pre-dose and at post-dose at 25 minutes, 1 hour 55 minutes, 3 hours 55 minutes and 23 hours 40 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of IC, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilators as covariates and center nested in region as a random effect. IC measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were set to missing.|Day 1, Days 84/85|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Liters||Standard Error|Least Squares Mean
2657627|NCT01604278|Secondary|Forced Vital Capacity (FVC) at Individual Time-points|FVC was calculated at each time point up to 4 hours post-dose and at 23 hours 15 minutes and 23 hours 45 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FVC, FEV1 prior to inhaltion of short acting bronchodilators and FEV1 post inhaltion of short acting bronchodilators as covariates and center nested in region as a random effect. FVC measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were set to missing.|Day 1, Day 29, Day 57 and Days 84/85|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Liters||Standard Error|Least Squares Mean
2657628|NCT01604278|Secondary|FEV1 at Individual Time-points|Centralized spirometry according to internationally accepted standards was used. FEV1 was measured at all post-dose time points up to 4 hours, and at 23 hours 15 minutes and 23 hours 45 minutes, by visit. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhaltion of short acting bronchodilators and FEV1 post inhaltion of short acting bronchodilators as covariates and center nested in region as a random effect. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.|Day 1, Day 29, Day 57 and Days 84/85|Full Analysis Set|||Liters||Standard Error|Least Squares Mean
2657629|NCT01604278|Secondary|Peak FEV1 During 30 Minutes to 4 Hours Post-dose at 12 Weeks|Centralized spirometry was used according to internationally accepted standards was used. Peak FEV1 was defined as the maximum FEV1 during the first 4 hours post morning dosing. The model contained treatment, baseline smoking status and baseline ICS use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilator as covariates and center nested in a region as a random effect. If all FEV1 measurements were missing from 30 minutes onward, the peak FEV1 was not calculated. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.|12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Liters||Standard Error|Least Squares Mean
2657630|NCT01604278|Secondary|FEV(1) Area Under the Curve (AUC) During 30 Minutes to 4 Hours Post Dose|Centralized spirometry was used according to internationally accepted standards was used. The trapezoidal rule was applied to calculate FEV1 Area Under the Curve (AUC) and then normalized to the length of time. Whether the participants had complete or incomplete FEV1 assessments in respective time ranges, their AUCs were calculated based on the existing FEV1 measurements (i.e., the missing FEV1 measurements were not interpolated). Specifically, for those participants who had a FEV1 assessment at only one time-point, their AUC was approximated by the observed FEV1. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.|12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Liters||Standard Error|Least Squares Mean
2657631|NCT01604278|Primary|Trough Forced Expiratory Volume at 1 Second (FEV1)|Centralized spirometry according to internationally accepted standards was used. The model contained treatment, baseline smoking status and baseline inhaled corticosteroid (ICS) use as fixed effects with the baseline measurement of FEV1, FEV1 prior to inhalation of short acting bronchodilators and FEV1 post inhalation of short acting bronchodilator as covariates and center nested in region as a random effect. If trough FEV1 was missing at week 12, the latest non-missing pre-dose trough FEV1 (the mean of 45 and 15 min pre-dose measurements) from day 29, 57 or 84) was carried forward. These measurements had to have been taken before the next dose of study medication. FEV1 measurements within 6 hours of rescue medication use or within 7 days of systemic corticosteroid use were not included in the analysis.|12 weeks|Only participants from the full analysis set, who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed.|||Liters||Standard Error|Least Squares Mean
2657632|NCT01604265|Secondary|Incidence of Adverse Events as a Measure of Patient Safety.|The number of patients who experienced an adverse event during the course of the study is presented.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||participants|||Number
2657633|NCT01604265|Secondary|Change From Baseline in the Multiple Sclerosis Functional Composite Score at the End of Treatment (4 Weeks)|The Multiple Sclerosis Functional Composite test is a three-part, standardized, quantitative, assessment instrument for use in clinical studies. The three components of the test measure leg function/ambulation, arm/hand function, and cognitive function. An increase in score indicates an improvement (range -3 to +3).|Baseline to end of treatment (0 - 4 weeks).|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657634|NCT01604265|Secondary|Change From Baseline in The Hospital Anxiety and Depression Scale Score for Anxiety at the End of Treatment (4 Weeks)|Depression and anxiety was assessed using The Hospital Anxiety and Depression Scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 giving a total score between 0 and 21 for either anxiety or depression. A reduction in score indicates an improvement. The change from baseline in the overall anxiety score at the end of treatment is presented.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657635|NCT01604265|Secondary|Change From Baseline in The Hospital Anxiety and Depression Scale Score for Depression at the End of Treatment (4 Weeks)|Depression and anxiety was assessed using The Hospital Anxiety and Depression Scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 giving a total score between 0 and 21 for either anxiety or depression. A reduction in score indicates an improvement. The change from baseline in the overall depression score at the end of treatment is presented.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657636|NCT01604265|Secondary|Change From Baseline in the Mean 0-100 mm Visual Analogue Scale Score for Intoxication Levels at the End of Treatment (4 Weeks)|"Intoxication levels were recorded on a Visual Analogue Scale, where zero equated with no intoxication and 100 equated with extreme intoxication. A decrease in baseline score indicates a reduction in intoxication."|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657637|NCT01604265|Secondary|Change From Baseline in the Mean Total Guy's Neurological Disability Scale Score at the End of Treatment (4 Weeks)|The Guy's Neurological Disability Scale has 12 separate categories which include cognition, mood, vision, speech, swallowing, upper limb function, lower limb function, bladder function, bowel function, sexual function, fatigue, and 'others'. Each category consists of a series of questions, which are scored on a 0 to 5 scale, with 0 being indicative of a better outcome and 5 being indicative of a worse outcome. The total Guy's Neurological Disability Scale score is the unweighted sum from the 12 categories with a minimum score of 0 and maximum of 60. A negative value indicates an improvement in score from baseline.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657638|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Word List Generation' at the End of Treatment (4 Weeks)|Word list generation measures verbal associative fluency. Patients are given 60 seconds to give as many words beginning with a particular letter. The Total is the unweighted sum of all admissible words over three different trials. Higher scores indicate a better cognitive performance (min=0, max= not defined).|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||number of words||Standard Deviation|Mean
2657639|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for the 'Paced Auditory Serial Addition Task' (PASAT) at the End of Treatment (Week 4)|The Paced Auditory Serial Addition Task assesses sustained attention and concentration. A pre-recorded tape is used to present two series of 60 numbers, one every 3 seconds and one every 2 seconds. Patients are asked to add each number to the one immediately preceding it and give the result. The task summary score is the percentage of correct answers is calculated. The PASAT score range was 0% to 100%. Higher scores indicate a better cognitive performance.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||percentage of correct answers||Standard Deviation|Mean
2657640|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Symbol Digit Modalities' at the End of Treatment (Week 4)|The Symbol Digit Modalities Test measures complex attention and concentration in a task which also requires speed and accuracy in visual search and scanning. Patients are required to associate symbols with numbers and quickly generate the number when shown the symbol. The summary endpoint is the number of correct responses in 90 seconds. The symbol digit modalities test had a min of 0 and max score of 99. A higher score indicates better cognitive performance.|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657641|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for '10/36 Spatial Recall' at the End of Treatment (Week 4)|The 10/36 Spatial Recall Test assesses visual spatial learning and delayed recall. Patients are asked to view a 6 x 6 checkerboard with ten checkers for 10 seconds. They are then asked to recreate the pattern viewed on a blank checkerboard. The number of correct responses from three immediate trials and one delayed trial (7 minute delay) are recorded. The Total number of correct responses is the unweighted sum from the four trials. The score for the 10/36 spatial recall test was the unweighted average of four individual study results (min=0 and max=40). A higher score indicates better cognitive performance.|Weeks 0 - 4|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657642|NCT01604265|Secondary|Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Selective Reminding' at the End of Treatment (Week 4)|The Selective Reminding Test measures verbal learning and delayed recall through a multiple-trial list-learning paradigm. Patients are presented aurally with a list of 12 words for trial 1 and are asked to recall as many as possible. For trials 2-6, there is a selective presentation of only those words not recalled on the previous trial. Trial 7 is similar to the other trials but is assessed after an 11-minute delay. The score for the selective reminding test is the unweighted average of seven individual study results (min=0 and max=84) Higher scores indicate a better cognitive performance.|Baseline to end of study (0 - 4 weeks)|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657643|NCT01604265|Secondary|Change From Baseline in the Mean Neuropathic Pain Scale 0-10 Numerical Rating Scale Score at the End of Treatment (Week 4)|The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = worst pain imaginable). A negative change from baseline indicates an improvement in pain.|Baseline to end of treatment (0 - 4 weeks).|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657644|NCT01604265|Secondary|Subject Global Impression of Change at Week 4|"A 7-point Likert-type scale was used, with the question: 'Please assess the improvement in overall condition since the start of the study using the scale below' with the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse. At Visit 2 (Baseline) patients wrote a brief description of their condition which was used at Week 4 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported."|4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||participants|||Number
2657645|NCT01604265|Secondary|Change From Baseline in the Mean 0-10 Numerical Rating Scale Sleep Score at the End of Treatment (4 Weeks)|"Each day patients were asked to record in their subject diary, whether or not they were woken due to nerve pain last night, using a 0-10 Numerical Rating Scale sleep score where zero equated with did not disrupt sleep and 10 meant completely disrupts sleep (unable to sleep due to pain). A decrease in score from baseline indicates an improvement."|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657646|NCT01604265|Primary|Change From Baseline in the Mean Pain 0-10 Numerical Rating Scale Score at the End of Treatment (4 Weeks)|"The average pain Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours where 0 = no pain and 10 = pain as bad as you can imagine. A negative value indicates an improvement in pain score from baseline."|0 - 4 weeks|All patients who were randomised, received at least one actuation of study medication and had some on-treatment efficacy data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2657647|NCT01604122|Primary|Caregiver Burden Items Assessment: Total Cost|Caregivers completed a series of questions related to the total cost spent on providing healthcare support to participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||dollars||Standard Deviation|Mean
2657648|NCT01604122|Primary|Caregiver Burden Items Assessment: Work Time Lost|Caregivers completed a series of questions related to the loss in their working time while providing care and support to the participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||hours||Full Range|Median
2657649|NCT01604122|Primary|Caregiver Burden Items Assessment: Number of Hours Per Week Spent in Care of the Participants With ATTR|Caregivers completed a series of questions related to the number of hours per week spent on providing care and support to the participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||hours per week||Full Range|Median
2657650|NCT01604122|Primary|Zarit Burden Interview: Subscale Scores|A questionnaire designed to evaluate aspects of caregiver burden in terms of personal and role strain associated with caregiving. Total score of ZBI scale ranges from 0-88 with higher scores indicating increased burden of care. Five subscale scores were also calculated: (1) Burden in the relationship (consist of 6-items, ranging from 0 to 24 where higher scores indicating increased burden in relationship); (2) Emotional well-being (consisting of 7-items, ranging from 0 to 28 where higher scores indicating worse condition; (3) Social and family life (consisting of 4-items, ranging from 0 to 16 where higher scores indicating worse life condition); (4) Finances (consisting of a single item, scored from 0 to 4 where higher scores indicating worse financial condition); and (5) Loss of control over one's life (consisting of 4-items, ranging from 0 to 16 where higher scores indicating worse control over life).|Baseline (Day 1)|All participants who were included in the study and completed the survey. Here, 'n' signifies those participants who were evaluable for specific category.|||units on a scale||Standard Deviation|Mean
2657651|NCT01604122|Primary|Zarit Burden Interview (ZBI): Total Scores|"ZBI was a 22-item questionnaire designed to evaluate five broad aspects of caregiver burden in terms of personal and role strain associated with caregiving. Five broad aspects were: burden in the relationship, emotional well-being, social and family life, finances, loss of control over one's life. Each item rated on a 5 point scale anchored at 0 for never and 4 for nearly always. Total score ranges from 0-88 with higher scores indicating increased burden of care."|Baseline (Day 1)|All participants who were included in the study and completed the survey.|||units on a scale||Standard Deviation|Mean
2657652|NCT01604122|Primary|Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores|KCCQ was a 23-item participant-completed questionnaire that assessed health status and health-related quality of life (HRQoL) in participants with heart failure. It was quantified in to following 10 summary scores: physical limitation, symptom frequency, symptom severity, and symptom stability, total symptoms, quality of life, social interference, self-efficacy, overall summary and clinical summary. Each summary score was scaled to range from 0 (minimum) to 100 (maximum), with higher scores representing greater disability. Total score ranged from 0 to 100, where higher scores indicated better functioning, fewer symptoms, and better disease specific quality of life.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2657653|NCT01604122|Primary|Norfolk Quality of Life-Diabetic Neuropathy Total Quality of Life: Subscale Scores|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of neuropathy on the quality of life of participants diagnosed with ATTR. It was summarized in 5 domains: (1) Activities of daily living (score ranges from 0 to 20, where higher score=worse quality of life); (2) Large fiber neuropathy/physical functioning (score ranges from -2 to 58, where higher score=worse condition); (3) Small fiber neuropathy (score ranges from 0 to 16, where higher score=worse condition); (4) Autonomic neuropathy (score ranges from 0 to 12, where higher score=worse condition) and (5) Symptoms (score ranges from 0 to 32, where higher score=less symptoms of disease). Total possible score range= -2 to 138, where higher score=worse quality of life. This outcome measure was analyzed only for the participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for specific category.|||units on a scale||Standard Deviation|Mean
2657654|NCT01604122|Primary|Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL): Total Scores|Norfolk QOL-DN: 35-item participant-rated questionnaire used to assess impact of neuropathy on the quality of life of participants diagnosed with ATTR. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: activities of daily living, large fiber neuropathy/physical functioning, small fiber neuropathy, autonomic neuropathy, and symptoms. TQOL= sum of all the items, total possible score range= -2 to 138, where higher score=worse quality of life. This outcome measure was planned to be analyzed only for the reporting arm of participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2657655|NCT01604122|Primary|Participants Pain Score|Participants diagnosed with ATTR rated their pain due to the health condition based on 3 items: pain right now, average pain in the past week, and worst pain in the past week prior to baseline visit. All 3 items were rated on an 11-point numeric rating scale ranging from 0=none to 10=severe pain, where higher scores indicated severe pain.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2657656|NCT01604122|Primary|Healthcare Resource Use Survey: Out-of-Pocket Costs|Healthcare resources use survey of participants diagnosed with ATTR was assessed by questions concerning a variety of treatments and resources included outpatient visits to healthcare providers, hospitalizations, emergency/urgent care visits, symptomatic treatments, and out-of-pocket costs (expenditure on nutritional supplements, non-prescription medications and travel to receive medical care).|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, 'n' signifies those participants who were evaluable for specific category.|||dollars||Full Range|Median
2657657|NCT01604122|Primary|Healthcare Resource Use Survey: Number of Symptomatic Treatment Visits|Healthcare resources use survey of participants diagnosed with ATTR was assessed by questions concerning a variety of treatments and resources included outpatient visits to healthcare providers, hospitalizations, emergency/urgent care visits, symptomatic treatments, and out-of-pocket costs. Number of visits of participants (diagnosed with ATTR) who visited non-medical practitioners (nutrition consultant/dietician, chiropractor, acupuncturist, massage therapist, occupational therapist or other than these) for symptomatic treatments were reported.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for specific category.|||symptomatic treatment visits||Standard Deviation|Mean
2657658|NCT01604122|Primary|Healthcare and Resource Use Survey: Symptomatic Treatment of Participants|Healthcare resources use survey of participants diagnosed with ATTR was assessed by questions concerning a variety of treatments and resources included outpatient visits to healthcare providers, hospitalizations, emergency/urgent care visits, symptomatic treatments, and out-of-pocket costs. Number of participants (diagnosed with ATTR) who visited non-medical practitioners (nutrition consultant/dietician, chiropractor, acupuncturist, massage therapist, occupational therapist or other than these) for symptomatic treatments were reported.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey.|||participants|||Number
2657659|NCT01604122|Primary|Healthcare Resource Use Survey: Number of Emergency Care Visits|Healthcare resources use survey of participants diagnosed with ATTR and caregivers was assessed by questions concerning a variety of different types of treatment and resources including outpatient visits to healthcare providers, hospitalizations, emergency/urgent care visits, symptomatic treatments, and out-of-pocket costs (for example, costs of travel to receive care).|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||emergency care visits||Standard Deviation|Mean
2657660|NCT01604122|Primary|Healthcare Resource Use Survey: Number of Hospitalizations|Healthcare resources use survey of participants diagnosed with ATTR and caregivers was assessed by questions concerning a variety of different types of treatment and resources including outpatient visits to healthcare providers, hospitalizations, emergency/urgent care visits, symptomatic treatments, and out-of-pocket costs (for example, costs of travel to receive care).|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||hospitalization visits||Standard Deviation|Mean
2657661|NCT01604122|Primary|Healthcare Resource Use Survey: Number of Outpatient Visits to Healthcare Providers|Healthcare resources use survey of participants diagnosed with ATTR and caregivers was assessed by questions concerning a variety of different types of treatment and resources including outpatient visits to healthcare providers, hospitalizations, emergency/urgent care visits, symptomatic treatments, and out-of-pocket costs (for example, costs of travel to receive care).|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, 'n' signifies those participants who were evaluable for specific category for each arm respectively.|||outpatient visits||Standard Deviation|Mean
2657662|NCT01604122|Primary|Work Productivity and Activity Impairment- Specific Health Version: Percent Activity Impairment|The WPAI assesses work productivity and impairment. It was a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days prior to baseline visit. The questionnaire asks about current employment status, hours worked, hours missed from work and degree to which a specified health problem (ATTR) or caregiving affected work productivity and regular activities. Component scores included percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. The computed percentage range for each sub-scale was from 0-100, where higher numbers indicating greater impairment and less productivity.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2657671|NCT01604122|Primary|Disease Characteristics of Participants: Number of Participants With Family History of ATTR|Family history of participants diagnosed with ATTR was assessed to determine whether family history of ATTR was a significant risk factor for ATTR or not. This outcome was planned to be assessed for reporting arm of participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey.|||participants|||Number
2657663|NCT01604122|Primary|Work Productivity and Activity Impairment- Specific Health Version: Percent Overall Work Impairment|The WPAI assesses work productivity and impairment. It was a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days prior to baseline visit. The questionnaire asked about current employment status, hours worked, hours missed from work and degree to which a specified health problem (ATTR) or caregiving affected work productivity and regular activities. Component scores included percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. The computed percentage range for each sub-scale was from 0-100, where higher numbers indicating greater impairment and less productivity.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2657664|NCT01604122|Primary|Work Productivity and Activity Impairment- Specific Health Version: Percent Impairment While Working|The WPAI assesses work productivity and impairment. It was a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days prior to baseline visit. The questionnaire asks about current employment status, hours worked, hours missed from work and degree to which a specified health problem (ATTR) or caregiving affected work productivity and regular activities. Component scores included percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. The computed percentage range for each sub-scale was from 0-100, where higher numbers indicating greater impairment and less productivity.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2657665|NCT01604122|Primary|Work Productivity and Activity Impairment- Specific Health Version (WPAI-SH): Percent of Work Time Missed|The WPAI assesses work productivity and impairment. It was a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days prior to baseline visit. The questionnaire asked about current employment status, hours worked, hours missed from work and degree to which a specified health problem (ATTR) or caregiving affected work productivity and regular activities. Percentage of work time missed of participants were recorded and reported.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||percentage of work time missed||Full Range|Median
2657666|NCT01604122|Primary|Euro Quality of Life (EQ-5D-3L)- Visual Analog Scale (VAS) Score|EQ-5D: participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. The VAS component rated the current health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2657667|NCT01604122|Primary|Euro Quality of Life (EQ-5D-3L)- Health State Profile Utility Score|EQ-5D-3L: participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of 0.05 to 1.00; higher scores indicating a better health state.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2657668|NCT01604122|Primary|Hospital Anxiety and Depression Scale (HADS): Depression and Anxiety Subscale Scores|HADS: participant rated 14-item questionnaire with 2 subscales; HADS-anxiety scale (HADS-A) and HADS-depression scale (HADS-D). HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items and the participant responds as to how each item applies to him/her over the past week prior to baseline visit, on 4-point response scale. Separate scores were calculated for anxiety and depression with score ranges from 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range was from 0 to 21 for each subscale; higher score indicating greater severity of anxiety and depression symptoms.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2657669|NCT01604122|Primary|12-Item Short-Form Health Survey (SF-12) Scores|SF-12 was a patient reported outcome survey that represented overall health status by measuring 8 health-related aspects of an individual: Body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Responses on the SF-12 were also used to calculate 2 summary scores: Physical component score (PCS) and mental component score (MCS). The score range for each of these 2 summary scores was from 0 (poor health) to 100 (better health), where 100 indicated good health condition.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, 'n' signifies those participants who were evaluable for specific component for each arm respectively.|||units on a scale||Standard Deviation|Mean
2657670|NCT01604122|Primary|Disease Characteristics of Participants: Mobility Status|Mobility, i.e., ability to walk was assessed as a part of loss of functioning in the participants diagnosed with ATTR. In this outcome, number of participants with their different mobility status along with the use of mobility aids (able to walk normally, some problems with feet but able to walk without difficulty, some difficulty walking but can walk without help, confined to bed all the time, need 1 cane or crutch to walk, need 2 canes/crutches or a walker to walk) were reported.|Baseline (Day 1)|All participants who were included in the study and completed the survey.|||participants|||Number
2657672|NCT01604122|Primary|Disease Characteristics of Participants: Liver Transplantation Status|TTR protein is primarily synthesized in the liver. Liver transplantation was considered as one of the measure to eliminate the main source of variant TTR. In the study, participants who were diagnosed with ATTR were asked for their liver transplantation status (whether they had transplantation or not). In this outcome measure, number of participants with liver transplant status were reported. This outcome was planned to be assessed for reporting arm of participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey.|||participants|||Number
2657673|NCT01604122|Primary|Disease Characteristics of Participants: Mutation Type|Genetic mutation leads to misfolding of protein transthyretin (TTR) which results in ATTR. In this outcome, number of participants with each type of resulted mutation type (Val30Met, wild type TTR, Phe64Leu, Ser77Tyr, Thr60Ala or other than these) were reported. This outcome was planned to be assessed for reporting arm of participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey.|||participants|||Number
2657674|NCT01604122|Primary|Disease Characteristics of Participants: Disease Duration|Duration of disease was defined as the time from diagnosis of disease until baseline visit. This outcome measure was planned to be assessed for reporting arm of participants diagnosed with ATTR.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey.|||years||Full Range|Median
2657675|NCT01604122|Primary|Demographical Characteristics of Participants|Main characteristics included were education level and employment status which were asked from all participants and caregivers. Type of job (full-time, part-time) was asked only from those participants and caregivers who provided their employment status as employed. Those who were unemployed reported their cause of unemployment, whether it was due to ATTR or not.|Baseline (Day 1)|All participants who were enrolled in the study and completed the survey. Here, 'n' signifies those participants who were evaluable for specific category for each arm respectively.|||participants|||Number
2657676|NCT01604109|Secondary|Quantitative Light-induced Fluorescence (QLF) Parameters|percent fluorescence loss, lesion area, lesion volume|one calender year|||||||
2657677|NCT01604109|Primary|the Mean Number of Enamel Carious Lesion|tooth surface that was classified as ICDAS code 1-3|one calender year||||Surfaces||Standard Deviation|Mean
2657678|NCT01603940|Secondary|Vascular Stiffness by Augmentation Index|Estimate vascular stiffness by measuring augmentation index and compare it between losartan and benazepril groups.|12 weeks||||percentage of augmentation pressure||Inter-Quartile Range|Median
2657679|NCT01603940|Secondary|Diastolic Blood Pressure|Compare both group effects on diastolic blood pressure.|12 weeks||||mmHg||Inter-Quartile Range|Median
2657680|NCT01603940|Secondary|Systolic Blood Pressure|Compare both groups effects on systolic blood pressure.|12 weeks||||mmHg||Inter-Quartile Range|Median
2657681|NCT01603940|Secondary|Vascular Stiffness|Access vascular stiffness by pulse wave velocity and compare it between groups (losartan and benazepril).|12 weeks.||||m/s||Inter-Quartile Range|Median
2657682|NCT01603940|Primary|Endothelial Function|Access endothelial function by brachial flow-mediated vasodilation (FMD) and compare it between groups (losartan and benazepril) and its relationship to current statin use.|12 weeks||||percentage of maximal vasodilation||Inter-Quartile Range|Median
2657683|NCT01603875|Secondary|Side Effects of the Vaccines. These Include Pain, Swelling, Redness, Myalgia, Rash, Fever. Serious Adverse Events Will Also be Recorded.|"There are five injections, on day 0, 7, 28, 360 and 363.~The side effects will be record in number and percentage."|up to 7 days after each injection|||||||
2657684|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 374(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 374||||International unit per ml||Full Range|Geometric Mean
2657685|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 360(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 360||||International unit per ml||Full Range|Geometric Mean
2657686|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 42(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 42||||International unit per ml||Full Range|Geometric Mean
2657687|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 28(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 28||||International unit per ml||Full Range|Geometric Mean
2657688|NCT01603875|Primary|Rabies Neutralizing Antibodies Determine by Rapid Fluorescent Focus Inhibition Test (RFFIT)|Blood samples will be drawn on day 0(After the first injection). The samples will be centrifuged and kept as serum under - 20 degree Celsius. The serum will be test by Rapid Florescent Focus Inhibition Test. Rabies neutralizing antibody levels will be determined and expressed in international units per mL. Percentage of Subjects achieving seroconversion (defined as RNab ≥ 0.5 IU/ mL) are determine at each sampling time.|on day 0||||International unit per ml||Full Range|Geometric Mean
2658346|NCT01599104|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death|Participants were monitored for adverse events, serious adverse events and deaths throughout the study.|8 weeks|Safety Set. The safety set included aqll participants who had received study medication.|||Participants|||Number
2657689|NCT01603641|Primary|Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)|An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period.|From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks)|Safety population included all treated participants.|||percentage of participants|||Number
2657690|NCT01603628|Secondary|Change From Baseline in Severity of Spasticity of the Ankle With Knee Extended and Knee Flexed (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)|The MTS measured the difference between slow and fast range of motion (R2-R1) and respective change from baseline to each posttreatment office visit. The MTS of the ankle was used to determine the passive range of movement at different movement velocities, V1 (as slow as possible) and V3 (as fast as possible) with the relative difference between a slow and fast velocity passive stretch determining the dynamic component of the muscle contracture for the joint. The investigator measured 2 joint angles by goniometer: the R1 angle which is the angle of catch after a fast velocity (V3) stretch and the R2 angle defined as the passive joint range of movement following a slow velocity (V1) stretch. The R2-R1 value indicated the level of the dynamic component of spasticity in the joint. The difference between R2 and R1 range of motion and respective change from baseline to each posttreatment office visit on the MTS was derived. An Analysis of Covariance (ANCOVA) model was used for analysis.|Baseline (Day 1) to Weeks 2, 4, 6, 8 and 12|Participants from the mITT population, all randomized participants with a valid MAS-B baseline ankle score with knee extended and at least one post-baseline measurement at Weeks 2, 4, or 6 for the MAS-B of the ankle score with knee extended and the CGI by physician, with data available for analysis at the given time-point.|||degrees||Standard Error|Least Squares Mean
2657691|NCT01603628|Secondary|Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale|Two functional goals, one active and one passive, were selected by the participant and family in consultation with the physician investigator and/or treating physical therapist relative to the lower limb impairment due to spasticity. The physician assessed the achievement of the goals using a 6-point scale: where -3=worse than start to +2=much more than expected: improvements clearly exceed the defined therapeutic goal. An Analysis of Covariance (ANCOVA) model was used for analysis.|Weeks 8 and 12|Participants from the mITT population, all randomized participants with a valid MAS-B baseline ankle score with knee extended and at least one post-baseline measurement at Weeks 2, 4, or 6 for the MAS-B of the ankle score with knee extended and the CGI by physician, with data available for analysis at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
2657692|NCT01603628|Primary|Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6|The CGI of overall change (improvement or worsening) was assessed by the physician considering the participant's clinical condition and severity of side effects using a 9-point scale where: -4=very marked worsening to +4=very marked improvement. The scores at Weeks 4 and 6 were averaged. A Mixed Model Repeated Measures (MMRM) model was used for analysis.|Weeks 4 and 6|Participants from the mITT population, all randomized participants with a valid MAS-B baseline ankle score with knee extended and at least one post-baseline measurement at Weeks 2, 4, or 6 for the MAS-B of the ankle score with knee extended and the CGI by physician, with data available for analysis.|||score on a scale||Standard Error|Least Squares Mean
2657693|NCT01603628|Primary|Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Ankle Score With Knee Extended at Weeks 4 and 6|The MAS-B was used to evaluate spasticity based on grading the resistance encountered in the principal muscle group (elbow and wrist) by means of passively moving a limb through its range of motion at a study specified velocity. The resistance encountered to passive stretch was graded using a 6-point scale where: 0=no increase in muscle tone (best) to 4=affected part(s) rigid in flexion or extension (worst). For analysis purposes, the MAS-B was recoded as follows: 0=1, 1=1, 1+=2, 2=3, 3=4, 4=5. The scores at Weeks 4 and 6 were averaged. A Mixed Model Repeated Measures (MMRM) model was used for analysis. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Weeks 4 and 6|Participants from the mITT population, all randomized participants with a valid MAS-B baseline ankle score with knee extended and at least one post-baseline measurement at Weeks 2, 4, or 6 for the MAS-B of the ankle score with knee extended and the CGI by physician, with data available for analysis.|||score on a scale||Standard Error|Least Squares Mean
2657694|NCT01603615|Primary|Percentage of Participants With at Least One Treatment- Emergent Adverse Event (TEAE)|An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period. Safety population included all treated participants.|From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks)|Safety population included all treated participants.|||percentage of participants|||Number
2657695|NCT01603602|Secondary|Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS)|The MTS measured the difference between slow and fast range of motion (R2-R1) and respective change from baseline to each posttreatment office visit. The MTS of the ankle was used to determine the passive range of movement at different movement velocities, V1 (as slow as possible) and V3 (as fast as possible) with the relative difference between a slow and a fast velocity passive stretch determining the dynamic component of the muscle contracture for the joint. At each visit, the investigator measured 2 joint angles by goniometer: the R1 angle which is the angle of catch after a fast velocity (V3) stretch and the R2 angle defined as the passive joint range of movement following a slow velocity (V1) stretch. The R2 - R1 value indicated the level of the dynamic component of spasticity in the joint. The difference between slow (R2) and fast (R1) range of motion and respective change from baseline to each posttreatment office visit on the MTS was derived.|Baseline (Day 1) to Week 6|Participants from the mITT population, all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician, with data available for analysis at the given time-point.|||degrees||Standard Error|Least Squares Mean
2668020|NCT01509677|Secondary|Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (TIMP-1 (ng/mL))||Baseline to 14 weeks||||ng/mL||Standard Error|Least Squares Mean
2657696|NCT01603602|Secondary|Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale|Two functional goals, one active and one passive, were selected by the participant and family in consultation with the physician investigator and/or treating physical therapist relative to the lower limb impairment due to spasticity. The physician assessed the achievement of the goals using a 6-point scale: where -3=worse than start to +2=much more than expected: improvements clearly exceed the defined therapeutic goal. An ANCOVA model was used for analysis.|Week 8 and 12|Participants from the mITT population, all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician, with data available for analysis at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
2657697|NCT01603602|Secondary|Average Change From Baseline in MAS-B Score of the Finger Flexor Muscle Group at Weeks 4 and 6|The MAS-B was used to evaluate spasticity based on grading the resistance encountered in the finger flexor muscle group by means of passively moving a limb through its range of motion at a study specified velocity. The resistance encountered to passive stretch was graded using a 6-point scale where: 0=no increase in muscle tone (best) to 4=affected part(s) rigid in flexion or extension (worst). For analysis purposes, the MAS-B was recoded as follows: 0=1, 1=1, 1+=2, 2=3, 3=4, 4=5. The scores at Weeks 4 and 6 were averaged. An Analysis of Covariance (ANCOVA) model was used for analysis. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Weeks 4 and 6|Participants from the mITT population, all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician, with data available for analysis at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
2657698|NCT01603602|Primary|Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6|The CGI of overall change (improvement or worsening) was assessed by the physician considering the participant's clinical condition and severity of side effects using a 9-point scale where: -4=very marked worsening to +4=very marked improvement. The scores at Weeks 4 and 6 were averaged. A MMRM model was used for analysis.|Weeks 4 and 6|Participants from the m ITT population, all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician, with data available for analysis at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
2657699|NCT01603602|Primary|Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group at Weeks 4 and 6|The MAS-B was used to evaluate spasticity based on grading the resistance encountered in the principal muscle group (elbow and wrist) by means of passively moving a limb through its range of motion at a study specified velocity. The resistance encountered to passive stretch was graded using a 6-point scale where: 0=no increase in muscle tone (best) to 4=affected part(s) rigid in flexion or extension (worst). For analysis purposes, the MAS-B was recoded as follows: 0=1, 1=1, 1+=2, 2=3, 3=4, 4=5. The scores at Weeks 4 and 6 were averaged. A Mixed Model Repeated Measures (MMRM) model was used for analysis. A negative change from Baseline indicates improvement.|Baseline (Day 1) to Weeks 4 and 6|Participants from the Modified Intent-to treat (mITT) population, all randomized participants with a valid MAS-B baseline score and at least one post-baseline measurement at weeks 2, 4, or 6 for the MAS-B of the principal muscle group and the CGI by physician, with data available for analysis.|||score on a scale||Standard Error|Least Squares Mean
2657700|NCT01603459|Secondary|Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Positive values indicate improvement.|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657701|NCT01603459|Secondary|Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||subjects|||Number
2657702|NCT01603459|Secondary|Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Positive values indicate improvement|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657758|NCT01603368|Secondary|Head Circumference Growth (SD)|In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.|At 14th day of life||||change in standard deviations||Standard Deviation|Mean
2657703|NCT01603459|Secondary|Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||subjects|||Number
2657704|NCT01603459|Secondary|Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values represent better outcome).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657705|NCT01603459|Secondary|Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems). In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values indicate better outcome). This table: Frequency -2/-1= improvement by two/one categories; 0 = no change; +1/+2 worsening by one/two categories.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||Subjects|||Number
2657706|NCT01603459|Secondary|Visual Analogue Scale (VAS) of EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. In addition, the subject was to indicate on a visual analogue scale, ranging from 0 to 100, how good or bad their own health was on the examination day (higher values represent better outcome).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657707|NCT01603459|Secondary|EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores|The EQ-5D is a common quality of life questionnaire to be filled out by the subject. It evaluates the general impact of a subject's health in 5 dimensions, i.e., on the ability to perform daily physical activities as well as on pain perception and mood. Each dimension is scored on 1 out of 3 categories specific to each dimension, generally meaning: 1= no problem; 2 = moderate problems; 3 = severe problems.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||subjects|||Number
2657708|NCT01603459|Secondary|Global Assessment of Efficacy Scores|Investigator assessment. The global assessment of efficacy will be assessed by the investigator, the subject, and the caregiver using a 4-point Likert scale with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor.|Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||subjects|||Number
2657709|NCT01603459|Secondary|Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit.|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657710|NCT01603459|Primary|Investigator's Global Assessment of Tolerability in Subjects|A 4-point Likert scale was used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor.|Up to Week 48|Safety evaluation set (SES) - only subjects treated in the respective injection cycle were analyzed.|||subjects|||Number
2657711|NCT01603459|Primary|Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication|Treatment-emergent Adverse Events (TEASs) are events observed from the time point of first injection until 16 weeks after last injection. Values reported here refer to the number of subjects affected.|From baseline to week 36-48|Safety evaluation set (SES) - only subjects treated in the respective injection cycle were analyzed.|||subjects|||Number
2657712|NCT01603459|Secondary|Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Control Visits of Injection Cycles|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657713|NCT01603459|Secondary|Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Injection Cycle Baseline Visits to Respective Control Visits|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value change.|Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657714|NCT01603459|Secondary|Disability Assessment Scale (DAS) Scores in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which are assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability). One of the domains will be selected per subject per injection cycle. Arithmetic means are built on each patient's target domain value.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657715|NCT01603459|Secondary|Goal Attainment Scale (GAS) Scores for Upper and Lower Limb, Respectively|Change in goal attainment T-scores from respective injection cycle baseline visit. GAS measures the extent to which subject's individual goals are achieved in course of intervention. Subject and treating team have to identify 2 personal goals for each treated limb at each injection cycle. Investigator rates the GAS score for each injection cycle. Degree of goal attainment is rated on 5-point scale (-2, -1, 0, +1, +2; study baseline set to -1) and in order to account for interindividual differences in the number of goals, ratings are computed with the Kiresuk formula (Kiresuk & Sherman, Community Mental Health Journal. 1968;4(6):443-53) resulting in T-scores measuring the degree of goal attainment at each visit. A score of 50 indicates that the individual has reached the expected level of achievement for all goals. The size of change from measurement to measurement indicates incremental change towards or away from goal attainment. Positive values indicate a higher goal attainment.|From Cycle Baseline Visit to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657716|NCT01603459|Secondary|Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657717|NCT01603459|Secondary|Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Control Visits of Injection Cycles|The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657718|NCT01603459|Secondary|Change of Functional Ambulation Classification (FAC) Score From Injection Cycle Baseline Visits to Respective Control Visits|The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657719|NCT01603459|Secondary|Functional Ambulation Classification (FAC) Scale Scores|The FAC examines the independence and ambulation of subjects whereby supervision/physical assistance from 1 person is allowed. Subjects are classified to following categories: Level 0: no functional ambulation; Level 1: Ambulator-dependent for physical assistance (Level II); Level 2: Ambulator-dependent for physical assistance (Level I); Level 3: Ambulator-dependent for supervision; Level 4: Ambulator-independent, level surface only; Level 5: Ambulator-independent.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657720|NCT01603459|Secondary|Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.|From Study Baseline to Week 12-16, 24-32 and 36-48|The full analysis set is the subset of all subjects who were exposed to study medication at least once.|||units on a scale||Standard Deviation|Mean
2657721|NCT01603459|Secondary|Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Control Visits of Injection Cycles|The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.|From Study Baseline to Week 4, 16-20 and 28-36|The full analysis set is the subset of all subjects who were exposed to study medication at least once.|||units on a scale||Standard Deviation|Mean
2657759|NCT01603368|Secondary|Length Gain (SD)|In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.|At gestational week 36+0||||change in standard deviations||Standard Deviation|Mean
2657722|NCT01603459|Secondary|Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Injection Cycle Baseline Visits to Respective Control Visits|The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657723|NCT01603459|Secondary|Resistance to Passive Movement Scale (REPAS) Scores of Treated Side|The REPAS is a summary 26-item test used to assess resistance to passive movement in all four limbs of the body. It provides a global evaluation of spasticity status, as well as per hemibody and per limb. 16 items describe the condition of both upper limbs, 10 that of both lower limbs. Each item is rated by using the Ashworth Scale. The sum of the values represent the REPAS score which may range from zero (no resistance for any item) to 104 (limbs rigid for all items). Here, the hemi-REPAS was evaluated, i.e. the maximum value for the treated body side was 52.|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657724|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS) - only subjects treated in the respective pattern of respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657725|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles|Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS) - only subjects treated in the respective pattern of respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657726|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits|Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective pattern of respective injection cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657727|NCT01603459|Secondary|Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity|Clinical pattern treated at corresponding cycle of the same body side as the selected target joint. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS) - only subjects treated in the respective pattern in the respective injection cycle.|||units on a scale||Standard Deviation|Mean
2657728|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Study Baseline to Week 12-16, 24-32 and 36-48|Full analysis set (FAS), observed cases, only subjects treated in the target joint in the respective cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657729|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Control Visits of Injection Cycles|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Study Baseline to Week 4, 16-20 and 28-36|Full analysis set (FAS), observed cases, only subjects treated in the target joint in the respective cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657730|NCT01603459|Secondary|Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Injection Cycle Baseline Visits to Respective Control Visits|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Cycle Baseline to Week 4 of Each Cycle|Full analysis set (FAS), observed cases, only subjects treated in the target joint in the respective cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657731|NCT01603459|Secondary|Ashworth Scale (AS) Scores of the Target Joint Selected at Study Baseline Visit|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|From Cycle Baseline to Week 4 of Each Cycle|The full analysis set (FAS) is the subset of all subjects who were exposed to study medication at least once. Only subjects treated in the target joint in the respective cycle were analyzed.|||units on a scale||Standard Deviation|Mean
2657732|NCT01603420|Secondary|Assessment of Quality of Life - Summation of Relative Scores From the EPIC Instrument.|unable to assess due to lack of data|Up to 10 years|unable to assess due to study termination||||||
2657733|NCT01603420|Secondary|Assessment of Total Number of Biochemical Failure Events|The number of biochemical failure events will be assessed on both arms.|at study closure (22 months)||||participants|||Number
2657734|NCT01603420|Secondary|Assessment of Total Number of Survival Events With Comparison of Group Arms|The number of deaths in both arms will be assessed.|at study closure (22 months)||||participants|||Number
2657735|NCT01603420|Secondary|Assessment of Total Number of Salvage Androgen Deprivation Use With Comparison of Arms.|The total number of subjects with salvage androgen deprivation use will be assessed.|At study closure (22 months)||||participants|||Number
2657736|NCT01603420|Secondary|Assessment of Impotence by Summation of Relative Scores for Sexual Function From the EPIC Quality of Life Instrument.|unable to assess due to lack of data|Up to 10 years|unable to assess due to study termination||||||
2657737|NCT01603420|Secondary|Assessment of Total Number of Local/Distant Failures|The total number of local/distant failures will be assessed.|at time of study closure (22 months)||||participants|||Number
2657738|NCT01603420|Secondary|Assessment of Number of GI and GU Adverse Events|"Descriptive measurements of frequency will be compiled.~This study was terminated prior to the time frame of 3 years being reached. Therefore, this outcome was not assessed. Data were collected on toxicities up until study closure at 22 months. However, this timepoint was not indicated as a secondary objective in the protocol. Therefore, data was not analyzed at time of study closure."|at 3 years|||||||
2657739|NCT01603420|Secondary|Assessment of Number of Grade 2 or Higher Genitourinary (GU) and Gastrointestinal (GI) Adverse Events|Assessment will be performed using CTCAE v 4 criteria.|at 6 months||||incidences|||Number
2657740|NCT01603420|Primary|Phase 3 - Assessment of the Number of Freedom From Failure (FFF) Events Comparing the Chemotherapy Arm to the Standard Treatment Arm.|"The events for FFF will be the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA > = ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage androgen deprivation.~This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed."|at 5 years|This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed.||||||
2657741|NCT01603420|Primary|Phase 2 - Cumulative Number of Incidences of Grade 3 or Higher Adverse Events.|"Assessment will be performed using CTCAE v4 criteria.~This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months)."|2 years|This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months).|||events|||Number
2657742|NCT01603420|Primary|Phase 2 - Assessment of Number of Freedom From Failure Event Comparing Chemotherapy Arm to Standard Treatment Arm|"This endpoint will be examined if decision is made to not move forward with phase 3 study.~This study was terminated prior to a decision being made about moving on to a phase 3 study. Therefore, this outcome was not assessed."|at 5 years|||||||
2657743|NCT01603420|Primary|Phase 2 - Assessment of Number of Freedom From Failure Events in the Chemotherapy Arm|"Measurement of Freedom from Failure i.e. the first occurence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (Prostate Specific Antigen [PSA] > = 2 ng/ml over the nadir PSA discounting bounces per the investigators discretion), or the start of salvage therapy including androgen deprivation.~This study was terminated prior to the time frame of 2 years being reached. Therefore, this outcome was assessed at time of study closure (22 months)."|No failures were reported at the time of study termination (22 months). This outcome was originally written to assess failure at 2 years. However, that end point was not reached.|No failures were reported at the time of study termination (22 months). This outcome was originally written to assess failure at 2 years. However, that end point was not reached.|||failure events|||Number
2657744|NCT01603394|Secondary|Change From Baseline to End of the Study (Week 6) in the Daily Sleep Interference Diary (NRS) Mean Pain Score.|The pain-related sleep interference item rating scale is scored on an 11-point numeric rating scale (NRS-Sleep). It is self-administered by the participant in order to rate how pain has interfered with their sleep during the past 24 hours, ranging from 0 (pain does not interfere with sleep) to 10 (completely interferes (unable to sleep due to pain). Participants are to describe how their pain has interfered with their sleep during the past 24 hours by choosing the appropriate number on the numeric rating scale.|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
2657745|NCT01603394|Secondary|Short Form 12v2 Health Survey (SF 12v2) at Visit 2 (Week 0), and Week 6/Early Termination.|The Short-Form 12 Health Survey (SF-12v2) is a self-administered, validated questionnaire that measures each of the following 8 health aspects: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception over the past week. Higher scores indicate a better health-related quality of life.|Visit 2 (Week 0), and Week 6/Early Termination|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
2657746|NCT01603394|Secondary|Pain NRS Score; 1 Week Recall Period.|The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.|1 Week|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
2657747|NCT01603394|Secondary|Patient Catastrophizing Scale (PCS) at Visit 2 (Week 0) and Week 6.|"The PCS is a 13-item self report instrument and requires a Grade 6 reading level and has been translated into 12 languages. It instructs participants to reflect on past experience of pain and indicate their experience using a 5-point scale. The PCS was designed for research on catastrophizing and pain experience. Catastrophizing is associated with heightened pain and is an exaggerated negative mental set brought to bear during actual or anticipated painful experience. It is a multidimensional construct compromising elements of rumination, magnification, and helplessness and its factor structure has been replicated. It has a total score and three subscale scores (score range of 0-52)."|Visit 2 (Week 0), Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
2657748|NCT01603394|Secondary|Brief Pain Inventory (BPI sf) at Visit 2 (Week 0) and Week 6.|The Brief Pain Inventory-Short Form (BPI-sf) consists of 5 questions. Questions 1, 2, 3, and 4 measure pain on an 11-point scale from 0 (no pain) to 10 (worst pain possible).|Visit 2 (Week 0), Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
2657749|NCT01603394|Secondary|Patient Health Questionnaire-8 (PHQ-8) at Baseline and Week 6; Generalized Anxiety Disorder-7 (GAD-7) at Screening, Visit 2 (Week 0) and Week 6/Early Termination.|The PHQ-8 is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as 0 (not at all) to 3 (nearly every day). The PHQ-8 is a validated subset of the PHQ-9, which comprises the first 8 items of the measure. The GAD-7 is a 7-item questionnaire that assesses anxiety. Participants respond as to how each item applies to them on a 4 point response scale. The higher the score, the more severe the anxiety.|Screening, Visit 2 (Week 0) and Week 6/Early Termination|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
2657750|NCT01603394|Secondary|Proportion of Participants Within Each Phenotype Group as Determined by Sensory Symptom Clustering Using the PainPREDICT, PainDETECT and Neuropathic Pain Symptom Inventory at Baseline and Week 6.|To explore whether sensory symptom cluster analysis is useful for predicting treatment response in paticipants with PHN, identification of the phenotype was initially required of all participants using three different approaches (with or without the baseline PHQ-8, GAD-7 Pain Related Sleep Interference Score Scale, PCS): 1. PainDETECT at baseline, 2. PainPREDICT at baseline, 3. NPSI at baseline.|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
2657751|NCT01603394|Secondary|Proportions of Participants With >/=30% and >/=50% Pain Reduction Based on Daily Pain Diary at Baseline and Week 6.|"The daily pain diary consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants describe their pain during the previous 24 hours by choosing the appropriate number between 0 and 10. Self-assessment is performed daily at bedtime on a telephone via interactive voice response system (IVRS). The endpoint mean pain score is defined as the mean of the last 7 daily diary pain ratings while taking study medication in the open-label phase. Daily pain IVRS diaries were completed daily at bedtime from Visit 1 (Screening) through Visit 7/Early Termination. Participants were asked to complete their first IVRS daily at bedtime on the morning after Visit 1."|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
2657752|NCT01603394|Secondary|Patient Global Impression of Change (PGIC) at Week 6/Early Termination.|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|Week 6/Early Termination|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
2657753|NCT01603394|Secondary|Proportion of Phenotypes Within the 30% and 50% Responder Groups at Baseline and Week 6.|To explore whether sensory symptom cluster analysis is useful for predicting treatment response in paticipants with PHN, identification of the phenotype was initially required of all participants using three different approaches (with or without the baseline PHQ-8, GAD-7 Pain Related Sleep Interference Score Scale, PCS): 1. PainDETECT at baseline, 2. PainPREDICT at baseline, 3. NPSI at baseline. Then for each of the above phenotypes the distribution of the pregabalin responders (using 30% and 50%) were to be compared.|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
2657754|NCT01603394|Secondary|Neuropathic Pain Symptom Inventory (NPSI) at All Visits.|NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain.|All visits|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
2657755|NCT01603394|Primary|Change From Baseline in the Daily Pain Diary (Numerical Rating Scale, NRS) Mean Pain Score at the End of the Study (Week 6).|The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.|Baseline, Week 6|Only 9 of the 200 participants were enrolled into the trial, so we are unable to get adequate results from this study.||||||
2657756|NCT01603368|Secondary|Head Circumference Growth (SD)|In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.|At gestational week 36+0||||change in standard deviations||Standard Deviation|Mean
2657757|NCT01603368|Secondary|Head Circumference Growth (SD)|In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.|At 28th day of life||||change in standard deviations||Standard Deviation|Mean
2657762|NCT01603368|Secondary|Weight Gain (SD)|In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.|At gestational week 36+0||||change in standard deviations||Standard Deviation|Mean
2657763|NCT01603368|Secondary|Weight Gain (SD)|In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.|At 28th day of life||||change in standard deviations||Standard Deviation|Mean
2657764|NCT01603368|Secondary|Bronchopulmonary Dysplasia|Need of oxygen or CPAP/ventilator at gw 36+0|Gw 36+0|Only patients surviving to gestational week 36+0 could be assessed for the diagnosis.|||participants|||Number
2657765|NCT01603368|Secondary|Sepsis|Blood culture positive sepsis|Birth to gw 36+0||||participants|||Number
2657766|NCT01603368|Secondary|Necrotizing Enterocolitis|Bell´s criteria II-III|Birth to gw 36+0||||participants|||Number
2657767|NCT01603368|Secondary|Mortality||Birth to gw 36+0||||participants|||Number
2657768|NCT01603368|Secondary|Weight Gain (SD)|In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.|At 14th day of life||||change in standard deviations||Standard Deviation|Mean
2657769|NCT01603368|Secondary|Time Until Birth Weight is Regained. Specifies the Number of Full Days the Child Has Lived.|Specifies the number of full days the child has lived.|Birth to gw 36+0|||||||
2657770|NCT01603368|Secondary|Number of Stools||Recorded over the first four weeks|Only infants with complete records of stools during the first four weeks are included|||number of stools||95% Confidence Interval|Mean
2657771|NCT01603368|Secondary|Days With Halted Feeding Due to Food Intolerance|Episode with food intolerance. Retention volume> food volume given the last 2 hours (retention checked routinely every 4 hours) and/or clinical signs consistent with necrotizing enterocolitis (reduced general condition and inflated abdomen). The number of such events will also be indicated.|Birth to gestational week 36||||days||Inter-Quartile Range|Median
2657772|NCT01603368|Primary|Time to Establish Full Enteral Feeds|The age of the infants in days when the infant receive 150 ml/kg/day via enteral feeding for the first time.|Birth to gestational week 36+0|Six infants – Four allocated to receive L. reuteri and two allocated to the placebo group died before reaching full enteral feeding and were not included in the analyses.|||days||Inter-Quartile Range|Median
2657773|NCT01603355|Primary|Number of Participants With Control of Ocular Inflammation|control of anterior chamber cell in both eyes at week 16 to a level of trace or less (SUN criteria) without an increase in any immunosuppressive treatment and while using prednisolone acetate topically no more than 2 times per day|16 Weeks||||Participants|||Count of Participants
2657774|NCT01603277|Secondary|To Evaluate the Safety and Tolerability of KB003 as Measured by Frequency and Severity of AEs, Clinical Safety, Laboratory Abnormalities and Chest Radiographic Assessments||Week 24|||||||
2657775|NCT01603277|Secondary|To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF)||Week 24|||||||
2657776|NCT01603277|Secondary|To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate||Week 24|||||||
2657777|NCT01603277|Primary|Change in Percent Predicted FEV1 at Week 24||Baseline to Week 24||||Percent||Standard Deviation|Mean
2657778|NCT01603121|Secondary|Evaluation of Early Efficacy of Study Drug|Blood draws will be performed at predetermined time points during and after the infusions in order to measure serum cytokine and chemokine concentrations, as well as to measure plasma STAT 4 and phosphorylated STAT 4 (markers of lisofylline efficacy).|24 hours|||||||
2657779|NCT01603121|Secondary|Study Drug Bioavailability After Subcutaneous and Intravenous Infusion|Blood will be collected for determination of lisofylline concentrations at various predetermined time points during the infusions, and 10 and 24 hours following infusion completion. This will help to determine if subcutaneous infusion over 10 hours results in similar lisofylline plasma concentrations as with intravenous infusion.|24 hours|||||||
2657780|NCT01603121|Primary|Safety and Tolerability of Study Drug|"Subjects will be monitored for adverse events both during and after the study drug infusion and will undergo physical examinations, electrocardiograms and clinical safety laboratory tests.~Study staff will contact subjects within 5 days after each dosing period and approximately 30 days after the 2nd dosing period, to review laboratory results and to ask the subject about any changes in health that they have experienced. Should the subject require an in-person evaluation, this will be arranged with the principal or sub-investigator promptly."|1 month|||||||
2657781|NCT01603082|Secondary|Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™|Participants with low (<150) baseline PRU values were excluded.|0.5 hours, end of PCI, and 8 hours after the loading dose|PD Analysis Set. Participants in the PD Analysis Set with low (<150) baseline PRU values were excluded from the analyses.|||PRU||Standard Deviation|Mean
2657782|NCT01603082|Primary|Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™|Participants with low (<150) baseline PRU values were excluded.|2 hours after the loading dose|Pharmacodynamic (PD) Analysis Set (N=93; 46 on ticagrelor, 47 on clopidogrel) - included all participants with PD data and without a major protocol deviation thought to significantly affect the PD of ticagrelor or clopidogrel. Participants in the PD Analysis Set with low (<150) baseline PRU values were excluded from the analyses.|||PRU||Standard Deviation|Mean
2657802|NCT01602744|Primary|SF-12 Health Survey questionnaire-the Physical Component Summary (PCS)|Quality of life was assessed by the SF-12 Health Survey questionnare. Results are expressed in terms of two meta scores:the Physical Component Summary (PCS) AND Mental Component Summary (MCS). The PCS and MCS scores have a range of 0 to 100, thus scores greater than 50 represent a better than average health status.|Outcome measures were assessed at the end of the 12 month follow up||||units on a scale||Standard Deviation|Mean
2657783|NCT01603056|Secondary|The Change From Baseline in Asthma Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated|"Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their Asthma symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores. The scores of all the medication used were summed to produce the daily asthma medication score range from 0 to 32. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome.~Baseline was set as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale(Medication score)||Standard Deviation|Mean
2657784|NCT01603056|Secondary|The Change From Baseline in Asthma Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.|The baseline AQLQ value was collected in Visit 1 (Week -8) and the 12 months' RQLQ value was collected in Visit 9 (Week 52). The maximum value of RQLQ score is 217 and the minimum one is 0. The score is elevated as the life quality is better.|Visit 1 date(Week -8), Visit 9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale(AQLQ score)||Standard Deviation|Mean
2657785|NCT01603056|Secondary|The Change From Baseline in Rhinitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their Rhinitis symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores. The scores of all the medication used were summed to produce the daily Rhinitis medication score range from 0 to 30. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome.~Baseline was set as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale(Medication score)||Standard Deviation|Mean
2657786|NCT01603056|Secondary|Global Assessment of Rhinoconjunctivitis Symptom After Treatment Between the Actively Treated Patients and the Placebo Treated.|Comparing overall rhinoconjunctivitis symptoms at the end of study year Between the Actively Treated Patients and the Placebo Treated.|Visit 9 date, Week 52|The analysis was performed in the Full Analysis Set.|||participants|||Number
2657787|NCT01603056|Secondary|The Change From Baseline in Rhinitis Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.|"The baseline RQLQ value was collected in Visit 1 (Week -8) and the 12 months' RQLQ value was collected in Visit 9 (Week 52).~The maximum value of RQLQ score is 168 and the minimum one is 0. The score is decreased as the life quality is better."|Visit 1 date(Week -8), Visit 9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale (RQLQ score)||Standard Deviation|Mean
2657788|NCT01603056|Secondary|The Change From Baseline in Nasal Complain Scores on Visual Analog Scale at 11-12 Months Between the Actively Treated Patients and the Placebo Treated.|"The average rhinoconjunctivitis VAS score (baseline to first year). The scale answers the question 'How have your nasal complaints been today?' from 0 = no symptoms to 10 = severe symptoms.~The baseline VAS rhinoconjunctivitis score is the average value of VAS scores in V1 (Screen Visit, Week -8) and V2 (Randomization visit, Week 0), and Evaluation period (Months 11-12) VAS rhinoconjunctivitis score is the average value of VAS scores in V8 (Week 44) and V9 (Week 52)."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale (VAS Score)||Standard Deviation|Mean
2657789|NCT01603056|Secondary|Percentage of Healthy Days in This Study Between the Actively Treated Patients and the Placebo Treated.|A healthy day is a day without rhinoconjunctivitis symptoms and without any intake of rescue medication. Percentage of healthy days is the healthy days of subject in this study divided by the total study days.|Total study year|The analysis was performed in the Full Analysis Set.|||Percentage of healthy days||Standard Deviation|Mean
2657790|NCT01603056|Secondary|The Change From Baseline in Asthma Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis.~A total of 4 Asthma symptoms were measured on a scale from 0-3 as follows:~0 = No symptoms.~= Mild symptoms.~= Moderate symptoms. 3= Severe symptoms. The 4 symptoms as follows: Cough, Wheeze, Chest tightness/shortness of breath (dyspnoea), Exercise induced symptoms. The 4 symptom scores were summed to obtain the asthma symptoms score with range 0(best) to 12(worst).~Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale(Symptom score)||Standard Deviation|Mean
2657803|NCT01602744|Secondary|Pharmacoeconomics Analysis-Costs of Medication|The costs on medications in the geriatric hospital before and after intervention e.g. pharmaeconomic analysis of the intervention. Costs of medications were calculated in New Israeli shekels per month and taken from the Ministry of Health's medication price list.|Outcome measures were assessed at the end of the 12 month follow up||||New Israeli shekels per month||Standard Deviation|Mean
2658883|NCT01593852|Secondary|Staff Dose Measured by DoseAware and Electronic Personal Dosimeter (EPD)|Staff dose measured by Electronic Personal Dosimeter (EPD) worn by the operator over the lead apron (EPD operator) and the other mounted at a fixed location in the EP laboratory (EPD fixed)|Day 0||||µSv||Inter-Quartile Range|Median
2657791|NCT01603056|Secondary|The Change From Baseline in Conjunctivitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis.~A total of 2 conjunctivitis symptoms were measured on a scale from 0-3 as follows:~0 = No symptoms.~= Mild symptoms.~= Moderate symptoms. 3= Severe symptoms. The 2 symptoms as follows: Gritty feeling/red/itchy eyes, Watery eyes. The 2 symptom scores were summed to obtain the conjunctivitis symptoms score with range 0(best) to 6(worst).~Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale(Symptom score)||Standard Deviation|Mean
2657792|NCT01603056|Secondary|The Change From Baseline in Rhinitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis.~A total of 4 rhinitis symptoms were measured on a scale from 0-3 as follows:~0 = No symptoms.~= Mild symptoms.~= Moderate symptoms. 3= Severe symptoms. The 4 symptoms are as follows: Runny nose, Blocked nose, Sneezing, Itchy nose. The 4 symptom scores were summed to obtain the rhinitis symptoms score with range 0(best) to 12(worst).~Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale (Symptom score)||Standard Deviation|Mean
2657793|NCT01603056|Primary|The Change From Baseline in Rhinoconjunctivitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their rhinoconjunctivitis symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores.The scores of all the medication used were summed to produce the daily rhinoconjunctivitis medication score range from 0 to 32. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome.~Baseline was from V1 (Week -8) to V2 (Week 0). The end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and End) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days in diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale (Medication Score)||Standard Deviation|Mean
2657794|NCT01603056|Primary|The Change From Baseline in Rhinoconjunctivitis Symptoms Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.|"Subjects completed symptom assessments and recorded the results in the patient diary cards on a daily basis. A total of six rhinoconjunctivitis symptoms were measured on a scale from 0-3 as follows:~0 = No symptoms.~= Mild symptoms.~= Moderate symptoms. 3= Severe symptoms.~The six symptoms are classified in 2 groups as follows:~Nose symptoms: Runny nose, Blocked nose, Sneezing, Itchy nose; Eye symptoms: Gritty feeling/red/itchy eyes, Watery eyes. The six symptom scores were summed to obtain the rhinoconjunctivitis symptoms score with range 0(best) to 18(worst).~Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average rhinoconjunctivitis symptoms scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary."|Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).|The analysis was performed in the Full Analysis Set.|||units on a scale (Symptom Score)||Standard Deviation|Mean
2657795|NCT01603043|Secondary|Mean Change From Baseline in BCVA at Month 12|Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.|Baseline (Day 0), Month 12|||||||
2657796|NCT01603043|Secondary|Yearly GA Lesion Size Growth Rate|Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.|Baseline (Day 0), up to Month 12|||||||
2657797|NCT01603043|Primary|Mean Change From Baseline in GA Lesion Size at Month 12 as Assessed With FAF Imaging|Efficacy analysis was not conducted due to the termination of the study prior to the primary and secondary efficacy endpoints and the small number of enrolled patients.|Day 0 (injection visit), Month 12|||||||
2657798|NCT01602965|Primary|Weight Loss|The measure of weight must be detected with the help of a balance. Weight is measured using Professional Dial Column Scales without shoes or heavy clothing to the nearest 0.1 kg.|Percent Change in weight loss at one year||||percentage of weight loss||Standard Deviation|Mean
2657799|NCT01602744|Primary|Functional Independence Measure (FIM)|Functioning was assessed by the FIM score. The FIM rates 18 activities of daily living on a 7 point scale ranging from fully dependent (=1) to independent (=7). A maximum score of 126 indicates functional independence and the lowest score of 18 indicates functional dependence.|Outcome measures were assessed at the end of the 12 month follow up||||units on a scale||Standard Deviation|Mean
2657800|NCT01602744|Primary|Hospitalizations|The average number of hospitalizations per year.|Outcome measures were assessed at the end of the 12 month follow up||||Number of hospitalizations per year||Standard Deviation|Mean
2657801|NCT01602744|Primary|Falls|Average number of falls per year.|At the end of the 12 month follow up||||Number of falls per year||Standard Deviation|Mean
2658073|NCT01601132|Primary|Apparent Total Body Clearance (CL/F) of Theophylline|Apparent total body clearance after oral administration, calculated as Dose /(AUC0-∞).|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|PK population|||liters/hour||Standard Deviation|Mean
2657804|NCT01602744|Primary|Quality of Life- Mental Component Summaty (MCS)|Quality of life will be measured by MOS SF-12 Health Survey questionnare. Results are expressed in terms of two meta scores: The Physical Component Summary(PCS) and the Mental Component Summary (MCS). The PCS and MCS scores have a range of 0 to 100, thus scores greater than 50 represent a better than average health status.|Outcome measures were assessed at the end of the 12 month follow up||||units on a scale||Standard Deviation|Mean
2657805|NCT01602731|Primary|Feasibility of AMDD to Improve Medication Adherence Via Completion Rate|Rate that patient population completed set-up of AMDD was evaluated quantitatively.|4 months|Of 45 patients who started the study, 24 patients met the predetermined criteria for AMDD. Though all of the patients had agreed to set up the AMDD in their home, only 15 out of 24 ended up completing the setup in their home.|||participants|||Number
2657806|NCT01602731|Secondary|Efficacy of AMDD to Improve Medication Adherence|Change in medication adherence (proportion of pills taken of prescribed, as measured by pillcount) after the implementation of the AMDD|30-day pill count before the use of AMDD and with AMDD||||percentage of adherence||Full Range|Mean
2657807|NCT01602679|Secondary|Change in Mean LH Amplitude|This secondary endpoint is the change in the mean LH amplitude (over 10 h), comparing (a) mean LH amplitude at baseline to (b) mean LH amplitude immediately after progesterone or placebo administration|10 hours following administration of micronized progesterone or placebo||||IU/L||Standard Deviation|Mean
2657808|NCT01602679|Secondary|Change in Mean LH|This secondary endpoint is the change of the mean LH (over 10 h), comparing (a) mean LH at baseline to (b) mean LH immediately after progesterone or placebo administration|10 hours following administration of micronized progesterone or placebo||||IU/L||Standard Deviation|Mean
2657809|NCT01602679|Primary|Change in Number of LH Pulses Per Hour|The primary endpoint is the change in the number of LH pulses per hour (over 10 h), comparing (a) number of LH pulses at baseline to (b) number of LH pulses immediately after progesterone or placebo administration|10 hours following administration of micronized progesterone or placebo||||pulses/h||Standard Deviation|Mean
2657810|NCT01602562|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35|The number of participants with normal, abnormal - clinically significant (CS), and abnormal - not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), at Screening and Day 35 are presented. Findings were determined to be normal, abnormal CS, and NCS by the investigator.|Screening (SCR) and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
2657811|NCT01602562|Secondary|Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35|Heart rate is defined as the number of heartbeats per unit of time. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Days 0, 7, 14, 21, and 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Beats per minute||Standard Deviation|Mean
2657812|NCT01602562|Secondary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35|Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Days 0, 7, 14, 21, and 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Millimeters of mercury||Standard Deviation|Mean
2657813|NCT01602562|Secondary|Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||ratio||Standard Deviation|Mean
2657814|NCT01602562|Secondary|Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35|Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), urine protein (UP), and urine urobilinogen (UUG). The dipstick is a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace, 1+, 2+, and 3+ (in order of increasing levels). Data are reported as the number of participants who had Neg, Trace, 1+, 2+, and 3+ levels at Screening, Day 14, and Day 35. If a category has not been reported for a specific parameter, then no participants were measured in that category.|Screening (SCR), Day 14, and 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
2657815|NCT01602562|Secondary|Mean Hemoglobin Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of hemoglobin at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Grams per liter (G/L)||Standard Deviation|Mean
2657865|NCT01602484|Secondary|Time to Apply Splint|Time it takes to apply splint|Immediately following the operation, beginning with when medical personnel finish preparing supplies and ending when the splint is applied (approximately 3 minutes)|One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.|||seconds||95% Confidence Interval|Mean
2657816|NCT01602562|Secondary|Mean Red Blood Cell Count at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of the red blood cell count at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||tera (10^12) per liter (TI/L)||Standard Deviation|Mean
2657817|NCT01602562|Secondary|Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of platelet count and WBC count at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||giga (10^9) per liter (GI/L)||Standard Deviation|Mean
2657818|NCT01602562|Secondary|Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Percentage of cells in blood||Standard Deviation|Mean
2657819|NCT01602562|Secondary|Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of albumin and total protein at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Grams per liter (G/L)||Standard Deviation|Mean
2657820|NCT01602562|Secondary|Mean Cholesterol, Chloride, Glucose, Potassium, Sodium, Triglyceride, and Urea/Blood Urea Nitrogen (BUN) Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of cholesterol, chloride, glucose, potassium, sodium, triglycerides, and urea/BUN at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2657821|NCT01602562|Secondary|Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of direct bilirubin, total bilirubin, creatinine, and uric acid at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2657822|NCT01602562|Secondary|Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LD) Values at Screening, Day 14, and Day 35|Blood samples were collected for the measurement of ALP, ALT, AST, CPK, GGT, and LD at Screening, Day 14, and Day 35.|Screening (SCR), Day 14, and Day 35|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters/at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.|||International units per liter (IU/L)||Standard Deviation|Mean
2657823|NCT01602562|Secondary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.|From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)|Safety Population: All participants who received VACV more than once.|||Participants|||Number
2657824|NCT01602562|Primary|Number of Participants With a Herpes Simplex Virus (HSV) Infection|Viral isolation/identification was conducted if the investigator (or subinvestigator) suspected HSV infection according to the relevant clinical symptoms (oral mucositis, skin infection, genital herpes, and pneumonia). If the result of viral isolation/identification was positive, the participant concerned was defined as a case of HSV infection. For reference, a virus deoxyribonucleic acid (DNA) identification (PCR) was simultaneously performed.|From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)|Full Analysis Set (FAS): all participants who were given VACV more than once and who could provide data evaluable with respect to the occurrence of HSV infection.|||Participants|||Number
2657825|NCT01602549|Secondary|GSK962040 Tmax at Day1 and Day 8|GSK962040 tmax was derived from GSK962040 plasma concentration-time data. Only participants who received GSK962040 50 mg were analyzed.|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Hours||Full Range|Median
2657826|NCT01602549|Secondary|GSK962040 Cmax at Day1 and Day 8|GSK962040 Cmax was derived from GSK962040 plasma concentration-time data. Only participants who received GSK962040 50 mg were analyzed.|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Nanograms/milliliter||Geometric Coefficient of Variation|Geometric Mean
2657827|NCT01602549|Secondary|GSK962040 Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) at Day 1|GSK962040 %AUCex was derived from GSK962040 plasma concentration-time data. %AUCex is the percentage of the AUC(0-inf) extrapolated from the last PK sample drawn to infinity. This parameter is only reported in conjunction with single-dose AUC(0-inf). Only participants who received GSK962040 50 mg were analyzed. AUC is a measure of levodopa exposure.|Day 1|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Percentage||Geometric Coefficient of Variation|Geometric Mean
2657828|NCT01602549|Secondary|GSK962040 Area Under the Plasma Concentration-time Curve From Zero to 5.5 Hours (AUC[0-5.5] and Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC[0-inf]) at Days 1 and 8|GSK AUC(0-5.5) and AUC(0-inf) were derived from GSK962040 plasma concentration-time data. Only participants who received GSK962040 50 mg were analyzed. AUC is a measure of levodopa exposure. Data for AUC(0-inf) was analyzed and was only available for Day 1 and not for Day 8.|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Nanograms.hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
2657829|NCT01602549|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect, is associated with liver injury and impaired liver function, or are serious events as per the medical or scientific judgment.|From the start of study medication until Follow-up (up to Day 25)|All Subjects Population|||Participants|||Number
2657830|NCT01602549|Secondary|Change From Baseline in Reticulocytes (RET) at Day 4 and Day 8|RET measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Tera (10^12) cells per liter||Standard Deviation|Mean
2657831|NCT01602549|Secondary|Change From Baseline in Red Blood Cell Count (RBC) and White Blood Cell Count (WBC) at Day 4 and Day 8|RBC and WBC measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Giga (10^9) cells per liter||Standard Deviation|Mean
2657832|NCT01602549|Secondary|Change From Baseline in Mean Corpuscle Volume (MCV) at Day 4 and Day 8|MCV measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Femtoliters||Standard Deviation|Mean
2657833|NCT01602549|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Day 4 and Day 8|MCH measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Picograms||Standard Deviation|Mean
2657834|NCT01602549|Secondary|Change From Baseline in Hematocrit at Day 4 and Day 8|Hematocrit measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||proportion of 1||Standard Deviation|Mean
2657835|NCT01602549|Secondary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Day 4 and Day 8|Hemoglobin and MCHC measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Grams per liter||Standard Deviation|Mean
2657836|NCT01602549|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Absolute Neutrophil Count (ANC), and Platelet Count (PC) at Day 4 and Day 8|Basophils, eosinophils, lymphocytes, monocytes, total ANC, and PC measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Giga (10^9) cells per liter||Standard Deviation|Mean
2657837|NCT01602549|Secondary|Change From Baseline in Calcium, Chloride, Carbon Dioxide Content (CO2)/Bicarbonate (BC), Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN), and Uric Acid (UA) at Day 4 and Day 8|Calcium, chloride, CO2/BC, glucose, potassium, sodium, urea/BUN, and UA measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Millimoles per liter||Standard Deviation|Mean
2657838|NCT01602549|Secondary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) at Day 4 and Day 8|ALP, ALT, AST, and GGT measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||International units per liter||Standard Deviation|Mean
2658305|NCT01599585|Secondary|Beck Depression Inventory -II (BDI-II)|The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.|3 month follow up||||units on a scale||Standard Deviation|Mean
2657839|NCT01602549|Secondary|Change From Baseline in Albumin (ALB) and Total Protein (TP) at Day 4 and Day 8|ALB and TP measurements were taken at pre-dose on Day 1 (Baseline), Day 4, and Day 8. Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 4, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Grams per liter||Standard Deviation|Mean
2657840|NCT01602549|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Day 1 and Day 8|ECG measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 8. The Baseline value was the Day 1 pre-dose value. ECG findings were categorized as normal, abnormal - not clinically significant, and abnormal - clinically significant (CS), based on interpretation by the site.|Day 1 and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Participants|||Number
2657841|NCT01602549|Secondary|Change From Baseline in Heart Rate at Day 1 and Day 8|Heart rate measurements were taken at pre-dose and 0 min (completion of meal) on Day 1 and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 1, and Day 8|ASP. Participants with available data (n=X, X in category titles) were analyzed.|||Beats per minute||Standard Deviation|Mean
2657842|NCT01602549|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 8|Blood pressure measurements were taken at pre-dose and at 0 min (completion of meal) on Day 1 and Day 8. The Baseline value was the Day 1 pre-dose value. Change from Baseline was calculated by subtracting the Baseline value from the individual post-Baseline value.|Baseline, Day 1, and Day 8|All Subjects Population (ASP): all participants who received >=1 dose of study medication. Participants with available data (n=X, X in category titles) were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
2657843|NCT01602549|Secondary|Total Daily L-DOPA Equivalent Dose at Baseline and on Days 1, 2, 3, 4, 5, 6, 7, 8, and 9|Various formulations of L-DOPA were utilized by participants for the treatment of Parkinson's Disease. The total daily L-DOPA equivalent dose was calculated as the sum of all L-DOPA equivalent doses for each L-DOPA-containing drug taken on the same day.|Baseline and Days 1, 2, 3, 4, 5, 6, 7, 8, and 9|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Milligrams||Standard Deviation|Mean
2657844|NCT01602549|Secondary|Number of Times a Participant Could Alternatively Tap Two Counter Keys 30 Centimeters Apart in 1 Minute (Min) at Baseline, Day1, Day 8, and Follow-up|Participants were asked to alternatively tap two keys 30 centimeters apart in 1 minute in two trials with the most affected hand or the dominant hand in symmetric disease. The finger tapping was scored manually by the study staff. The finger-tapping assessment was repeated at eight separate time points (pre-dose, 0 min, 30 min, 60 min, 90 min, 120 min, 180 min, and 240 min post-dose) at each visit (Baseline, Day 1, and Day 8). At each time point, the mean of the two assessments was calculated.|Baseline, Day 1, and Day 8 at pre-dose and 0, 30, 60, 90, 120, 180, and 240 minutes post-dose; Follow-up visit (up to Day 25)|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Finger taps per minute||Standard Deviation|Mean
2657845|NCT01602549|Secondary|"Period Mean Amount of Hours Spent ON, ON Without Dyskinesia, ON With Non-troublesome Dyskinesia, ON With Troublesome Dyskinesia, and OFF at Baseline and During the Treatment Period (Days 1-8), Week 1 of Follow-up, and Week 2 of Follow-up"|"Participants were provided with the ON/OFF diary to capture details of the amount of awake time spent on/off of PD symptoms, and were asked to complete the diary daily. Participants checked the box most appropriate for their dominant motor state in the preceding 30-minute period. The catergories included: ON (including ON without dyskinesia and ON with non-troublesome dyskinesia), ON with troublesome dyskinesia (TD), and OFF. For Baseline, data were collected for 2 days prior to Day 1, and the mean value of the 2 days was used."|Baseline, Days 1-8, Week 1 of Follow-up (Days 6 and 7 of Follow-up; up to Day 16), and Week 2 of Follow-up (Days 13 and 14 of Follow-up; up to Day 23)|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||hours||Standard Deviation|Mean
2657846|NCT01602549|Secondary|Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Scores at Baseline, Day 1, and Day 8 (Pre-dose; 120, 180, and 240 Minutes Post-dose)|The MDS-UPDRS is used to assess the status of Parkinson's Disease. It has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination), and Part IV (motor complications). Each part is made up of several questions, with each question given a score ranging from 0 (normal) to 4 (severe). Part I and Part II consist of 13 items each, and have a score ranging between 0 (normal) and 52 (severe). Part III consists of 33 items, and has a score ranging between 0 (normal) and 132 (severe). Part IV consists of 6 items, and has a score ranging between 0 (normal) and 24 (severe). The total score is the summed score of all four parts and ranges between 0 (normal) and 260 (severe). A higher score indicates more severe symptoms.|Baseline, Day 1, and Day 8 at pre-dose and 120, 180, and 240 minutes (min) post-dose (PD); Follow-up visit (up to Day 25)|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Scores on a scale||Standard Deviation|Mean
2657847|NCT01602549|Secondary|Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Scores at Baseline, Day 1, and Day 8 (Pre-levodopa Dose)|The MDS-UPDRS is used to assess the status of Parkinson's Disease. It has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination), and Part IV (motor complications). Each part is made up of several questions, with each question given a score ranging from 0 (normal) to 4 (severe). Part I and Part II consist of 13 items each, and have a score ranging between 0 (normal) and 52 (severe). Part III consists of 33 items, and has a score ranging between 0 (normal) and 132 (severe). Part IV consists of 6 items, and has a score ranging between 0 (normal) and 24 (severe). The total score is the summed score of all four parts and ranges between 0 (normal) and 260 (severe). A higher score indicates more severe symptoms.|Baseline, Day 1, and Day 8 at pre-levodopa dose|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Scores on a scale||Standard Deviation|Mean
2657866|NCT01602484|Secondary|Time to Prepare Splint|Time it takes to prepare splint supplies prior to splint application|Immediately following the operation, beginning with when medical personnel finish gathering supplies and ending when the materials are prepared to apply splint (approximately 2 minutes)|One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.|||seconds||95% Confidence Interval|Mean
2657848|NCT01602549|Secondary|Gastric Half Emptying Time (GE t1/2) at Baseline (BL), Day 1, and Day 8|Gastric half emptying time is the time taken for half the contents of the stomach to empty. Gastric emptying was measured using the 13C-oral breath test, which is a tracer method that utilizes 13C, a non-radioactive isotope. Basal breath samples were obtained after an overnight fast or otherwise after 4 hours of fasting following a light meal. On Day 1 and Day 8, participants were then dosed with GSK962040 and additional breath test samples were taken prior to administration of a 13C-labelled test meal. The test meal was consumed approximately 80 minutes later. After consumption of the test meal, breath samples were collected at pre-specified time points over an approximately 4 hour period following the test meal. For the duration of the breath test, no food or drink were allowed. The 13C breath content was determined by isotope ratio mass spectrometry. GE t1/2 was determined by using the cumulative percentage of the administered dose of 13C excreted in breath over 4 hours.|Baseline, Day 1, and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Minutes||Standard Deviation|Mean
2657849|NCT01602549|Primary|L-DOPA Terminal Phase Half-life (t1/2) at Baseline, Day 1, and Day 8|L-DOPA t1/2 was derived from L-DOPA plasma concentration-time data. This endpoint was not assessed because there were insufficient L-DOPA data/profiles to calculate this parameter.|Baseline, Day 1, and Day 8|||||||
2657850|NCT01602549|Primary|L-DOPA Time of Occurrence of Cmax (Tmax) at Baseline, Day 1,and Day 8|L-DOPA Tmax was derived from L-DOPA plasma concentration-time data.|Baseline, Day 1, and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Hours||Full Range|Median
2657851|NCT01602549|Primary|Dose-normalized L-DOPA Cmax at Day 1 and Day 8|Dose-normalized L-DOPA Cmax was derived from L-DOPA plasma concentration-time data. The adjusted means and ratios were estimated using a mixed model fitting treatment, visit, treatment*visit, Baseline L-dopa PK parameter, and Baseline gastric emptying half-time as fixed effects, and participant as a random effect.|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Nanograms/milliliter/milligram||Standard Error|Least Squares Mean
2657852|NCT01602549|Primary|Dose-normalized L-DOPA Maximum Observed Concentration (Cmax) at Baseline|Dose-normalized L-DOPA Cmax was derived from L-DOPA plasma concentration-time data.|Baseline|PD/Efficacy Population. Only those participants available at the specified time point were analyzed.|||Nanograms/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
2657853|NCT01602549|Primary|Dose-normalized L-DOPA AUC(0-4) at Day 1 and Day 8|Dose-normalized L-DOPA AUC(0-4) was derived from L-DOPA plasma concentration-time data. The adjusted means and ratios (GSK962040 50 mg: Placebo) were estimated using a mixed model fitting treatment, visit, treatment*visit, Baseline L-dopa pharmacokinetic (PK) parameter, and Baseline gastric emptying half-time as fixed effects, and participant as a random effect. AUC is a measure of levodopa exposure|Day 1 and Day 8|PD/Efficacy Population. Participants with available data (n=X, X in category titles) were analyzed.|||Nanograms*hour/milliliter/milligram||Standard Error|Least Squares Mean
2657854|NCT01602549|Primary|Dose-normalized Levodopa (L-DOPA) Area Under the Plasma Concentration-time Curve From Zero to 4 Hours AUC(0-4) at Baseline|Dose-normalized L-DOPA AUC(0-4) was derived from L-DOPA plasma concentration-time data. AUC is a measure of levodopa exposure.|Baseline|Pharmacodynamic (PD)/Efficacy Population: participants receiving >=1 dose placebo/GSK962040 50 mg. Only those participants available at the specified time point were analyzed.|||Nanograms*hour/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
2657855|NCT01602510|Secondary|Change From Baseline in Body Weight|Participant's body weight was measured on Weeks 0, 4, 8, 12, 16, 20, 24, 32 and 36. Analysis was performed using ANCOVA with covariates of site, CGI-S baseline score, treatment and baseline body weight. In presented LOCF datasets, the last non-missing on therapy score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. The baseline value was defined as the last non-missing values at or prior to the randomization. The change from baseline at the time point of interest was calculated by subtracting the baseline values from the individual post-baseline values. If either the baseline or post-baseline value was missing, the change from baseline was set to missing as well.|Baseline and up to 36 weeks.|RD Full Analysis Population. Only those par. with available data at indicated time points were analyzed.|||Kilograms||Standard Error|Least Squares Mean
2657856|NCT01602510|Secondary|Change From Baseline of Global Assessment Scale (GAS) Total Score|For GAS, investigators rated par. for lowest level of functioning during the previous week. The scale has a 10 score categories: 1-10, 11-20, 21-30, 31-40, 41-50, 51-60, 61-70, 71-80, 81-90, 91-100, using intermediary levels when appropriate (from 100 to 1, Lower is worse.). Data was collected on Weeks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 36. Analysis was performed using ANCOVA with covariates of site, CGI-S BL score, treatment and GAS total BL score. In presented LOCF datasets, the last non-missing on therapy score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. The BL value was defined as the last non-missing values at or prior to the randomization. The change from BL at the time point of interest was calculated by subtracting the BL values from the individual post-BL values. If either the BL or post-BL value was missing, the change from BL was set to missing as well.|Baseline and up to 36 weeks|RD Full Analysis Population|||Score on a scale||Standard Error|Least Squares Mean
2657857|NCT01602510|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score|YMRS consists of 11 items: Elevated Mood, Increased Motor Activity/Energy, Sexual Interest, Sleep, Irritability, Speech, Language/Thought Disorder, Content, Disruptive/Aggressive Behaviour, Appearance, and Insight. Investigators rated par. from 0 to 4 (or 8) for each of these items. Total score is the sum of all subscales, from 0 to 60 (higher is worse). Data was collected on Wks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 36. Analysis was performed using ANCOVA with covariates of site, CGI-S BL score, treatment and YMRS total BL score. In LOCF datasets, the last non-missing OT score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. BL value was defined as the last non-missing values at or prior to the randomization. Change from BL at the time point of interest was calculated by subtracting BL value from the individual post-BL value. If either the BL or post-BL value was missing, change from BL was set to missing.|Baseline and up to 36 weeks|RD Full Analysis Population|||Score on a scale||Standard Error|Least Squares Mean
2658884|NCT01593852|Primary|Cumulative Dose Area Product (DAP) Value|Percentage reduction of reduced X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in DAP.|Day 0||||Gy*cm^2||Inter-Quartile Range|Median
2657858|NCT01602510|Secondary|Change From Baseline in Hamilton Depression Rating Scale (HAMD)|HAMD consists of 17 items: depressed mood, feelings of guilt, suicide, insomnia-early, middle, late, work and activities, retardation, agitation, anxiety psychic, anxiety somatic, somatic symptoms gastro-intestinal, general somatic symptoms, hypochondriasis, loss of weight, and insight. Investigators rated par. from 0 to 4 (or 2) for these items. Total score is sum of all subscales (0 to 52, higher is worse). Data was collected on Wks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 36. Analysis was performed using ANCOVA with covariates of site, CGI-S baseline (BL) score, treatment and HAMD total BL score. The last non-missing OT score prior to TIME was carried forward to estimate missing data points for remaining study visits of the treatment period. BL value was defined as the last non-missing value at or prior to the randomization. Change from BL was calculated by subtracting BL from the specific post-BL value. If BL or post-BL value was missing, the change from BL was set to missing.|Baseline and up to 36 weeks|RD Full Analysis Population|||Score on a scale||Standard Error|Least Squares Mean
2657859|NCT01602510|Secondary|Change From Baseline in Clinical Global Impression of Severity (CGI-S)|The CGI-S is a 7-point scale where investigator were asked to rate the severity of the participant's illness at the time of assessment on severity of mental illness, where 1= normal, and 7= extremely ill. Data was collected on Weeks 0, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32 and 36. Analysis performed using Analysis of Covariance (ANCOVA) with covariates of site, CGI-S baseline score (Open label phase), treatment and CGI-S baseline score. In presented Last observation carried forward (LOCF) datasets, last non-missing on therapy score prior to TIME was carried forward to estimate missing data points for remaining study visits of treatment period. The baseline value was defined as last non-missing values at or prior to the randomization. The change from baseline at the time point of interest was calculated by subtracting the baseline values from individual post-baseline values. If either the baseline or post-baseline value was missing, the change from baseline was set to missing as well.|Baseline and up to 36 weeks|RD Full Analysis Population.|||Score on a scale||Standard Error|Least Squares Mean
2657860|NCT01602510|Secondary|Change From Baseline in Clinical Global Impression of Improvements (CGI-I)|The CGI-I is a 7-point scale where investigator were asked to assess the participant's illness at the time of assessment (improved or worsened) relative to a baseline state. In this scale, 1= very much improved; 2= much improved; 3= minimally improved; 4= no change; 5= minimally worse; 6= much worse; or 7= very much worse. Analysis was performed using Analysis of covariance with covariates of site, CGI-S baseline score and treatment. In presented Last-observation-carried-forward datasets, the last non-missing on therapy (OT) score prior to TIME was carried forward to estimate missing data points for the remaining study visits of the treatment period. Baseline value was defined as the last non-missing values at or prior to the randomization. Change from baseline at the time point of interest was calculated by subtracting the baseline values from the individual post-baseline values. If either baseline or post-baseline value was missing, the change from baseline was set to missing.|Baseline and up to 36 weeks|RD Full Analysis Population.|||Score on a scale||Standard Error|Least Squares Mean
2657861|NCT01602510|Secondary|Overall Survival in Study (TIME-SIS).|TIME-SIS was defined as the time to intervention (addition of pharmacotherapy or ECT) for any mood episode, or to the time when the participant is withdrawn for any reason after randomization. The premature discontinuation of a participant prior to reaching TIME, for any reason, was treated as an event related to bipolar disorder. All participants prematurely discontinued prior to the TIME event in this analysis were to be assumed to have reached TIME. TIMS-SIS was analyzed using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level. Par. prematurely discontinued from the study prior to reaching the event were censored at the time of discontinuation.|36 weeks|"RD Full Analysis Population. NA implies no data are available. Only those par. with available data at indicated time points were analyzed."|||Days||95% Confidence Interval|Median
2657862|NCT01602510|Secondary|Time to Intervention for Depressive Episode (TIDep)|TIDep was analyzed using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level. Par. prematurely discontinued from the study prior to reaching the event were censored at the time of discontinuation.|36 weeks|"RD Full Analysis Population. NA implies no data are available. Only those par. with available data at indicated time points were analyzed."|||Days||95% Confidence Interval|Median
2657863|NCT01602510|Secondary|Time to Intervention for Manic, Hypomanic or Mixed Episode (TIMan)|TIMan was analyzed using using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level. Par. prematurely discontinued from the study prior to reaching the event were censored at the time of discontinuation.|36 weeks|"RD Full Analysis Population.NA implies no data are available. Only those par. with available data at indicated time points were analyzed."|||Days||95% Confidence Interval|Median
2657864|NCT01602510|Primary|Time to Intervention for Any Mood Episode (TIME)|TIME is defined as being the time from entry into the randomized double-blind phase to the time of the first prescription of any additional pharmacotherapy or Electroconvulsive therapy (ECT) determined by the investigator to be necessary for treatment of a relapse and/or recurrence of a depressive, manic, hypomanic or mixed episode, whichever occurs first. TIME was measured relative to randomization date. Par. prematurely discontinued from the study prior to reaching the TIME event were censored at the time of discontinuation. Analysis was performed using Cox proportional hazards regression model with covariates of site, CGI-S baseline score, treatment and treatment by CGI-S baseline score interaction. The overall hazard ratio for treatment group could not be calculated due to different CGI-S baseline score level.|36 weeks (wks)|"Randomized (RD) Full analysis population: comprised of all randomized par. who took at least one dose of study medication and had at least one post-baseline efficacy/health outcomes assessment during randomized double-blind phase. NA implies no data are available. Only those par. with available data at indicated time points were analyzed."|||Days||95% Confidence Interval|Median
2658573|NCT01597375|Other Pre-specified|Effect of Prasugrel on Platelet Chemistry in Subjects With AERD During Aspirin Challenge.|To determine if treatment with prasugrel changes the baseline percentages of activated platelets or platelet-leukocyte aggregates or changes the plasma levels of soluble platelet products during clinical reaction to aspirin|Evaluated at visit 2 and 3 (week 8 and 14)|||||||
2657867|NCT01602484|Secondary|Time to Gather Supplies|Time it takes to gather supplies prior to splint application|Immediately following the operation, beginning with when medical personnel start to gather supplies and ending when they finish gathering supplies (approximately 1 minute)|One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.|||seconds||95% Confidence Interval|Mean
2657868|NCT01602484|Primary|Total Splint Application Time|Time it takes to apply post-op splint|Immediately following the operation, beginning at the start of gathering splint supplies and ending when splint application is completed (approximately five total minutes)|One patient from the bulk supply group because the subject's splinting was interrupted secondary to airway issues not related to the study.|||seconds||95% Confidence Interval|Mean
2657869|NCT01602471|Primary|[F-18]RDG-K5 Uptake by Carotid Plaque on PET Scan|Based on the small sample size and lack of IHC analyses, no efficacy conclusions can be drawn from this study.|Participants will be followed for an average of 6 weeks|||||||
2657870|NCT01602419|Post-Hoc|Clinical Symptoms of Von Willebrand Factor (VWF) Inhibition|Patients with a positive inhibitor tests were assessed for clinical symptoms of VWF inhibition|Optional antibody tests were performed at baseline and 3-4 days (preferable 7 days) after Wilate injection|Data was assessed for all patients in the SAF population who had a positive VWF inhibitor testing result as described in outcome 8.|||Participants|||Count of Participants
2657871|NCT01602419|Post-Hoc|Thromboembolic Adverse Drug Reactions (ADRs)|Patients with elevated F1 + F2 and/or D-dimer levels were monitored for thromboembolic ADRs|Optional thrombogenicity tests were performed at baseline and 1,3 and 24 hours after each administration of Wilate|Thromboembolic ADRs were analysed for all patients who has elevated F1 + F2 and/or D-dimer levels >2 times the upper limit of normal as identified in outcome 11.|||number of adverse drug reactions|||Number
2657872|NCT01602419|Other Pre-specified|Number of Patients With Breakthrough Bleeds During Prophylaxis|Breakthrough bleeds in patients receiving Wilate as prophylactic treatment on a continuous (EFF-PC population) or intermittent (EFF-PI population) basis were documented throughout the study.|Throughout the duration of each patient's participation in the study (study duration: mean [±SD]: 761 days [±251]; median [range]: 773 days [144-1185]).|Patients who received Wilate as prophylaxis were sub-divided into those who received prophylaxis on a continuous basis (EFF-PC Population) and those who received prophylaxis on an intermittent basis (EFF-PI).|||Participants|||Count of Participants
2657873|NCT01602419|Other Pre-specified|Wilate Dosage Per Procedure for the Prevention of Bleeding During and After Surgery|"Number and dosage of Wilate infusions administered to prevent bleeding during and after surgery were documented throughout the study.~For 6 infusions, no dosage information is available~One minor surgical procedure was not treated with Wilate. For 2 of the 98 treated surgical procedures, no dosage information is available (i.e., 1 major orthopedic surgery and 1 minor cardiovascular surgery)"|Throughout the duration of each patient's participation in the study (study duration: mean [±SD]: 568 days [±349]; median [range]: 732 days [2-1185]).|Efficacy of Wilate for the prevention of bleeding during and after surgery was assessed in the efficacy surgery (EFF-S) population that included 62 patients.|||IU/kg per procedure|Number of treated surgeries|Full Range|Median
2657874|NCT01602419|Other Pre-specified|Wilate Dosage Per Infusion for the Prevention of Bleeding During and After Surgery|"Number and dosage of Wilate infusions administered to prevent bleeding during and after surgery were documented throughout the study.~For 6 infusions, no dosage information is available~One minor surgical procedure was not treated with Wilate. For 2 of the 98 treated surgical procedures, no dosage information is available (i.e., 1 major orthopaedic surgery and 1 minor cardiovascular surgery)"|Throughout the duration of each patient's participation in the study (study duration: mean [±SD]: 568 days [±349]; median [range]: 732 days [2-1185]).|Efficacy of Wilate for the prevention of bleeding during and after surgery was assessed in the efficacy surgery (EFF-S) population that included 62 patients.|||IU/kg per infusion|Number of infusions|Full Range|Median
2657875|NCT01602419|Other Pre-specified|Dosage of Wilate for the Treatment of Breakthrough Bleeds Per Breakthrough Bleed|"Number and dosage of Wilate infusions administered as treatment for breakthrough bleeds in patients receiving prophylactic treatment on a continuous or intermittent basis were documented throughout the study.~n = For 1 bleed in the EFF-PC population, the dose is unknown."|Throughout the duration of each patient's participation in the study (study duration: mean [±SD]: 561 days [±251]; median [range]: 773 days [144-1185]).|Treatment of breakthrough bleeds (n=175) in the EFF-P population that included 25 patients.|||IU/kg per breakthrough bleed|No. of breakthrough bleeds|Full Range|Median
2657876|NCT01602419|Other Pre-specified|Dosage of Wilate Per Infusion for the Treatment of Breakthrough Bleeds|Number and dosage of Wilate infusions administered as treatment for breakthrough bleeds in patients receiving prophylactic treatment on a continuous or intermittent basis were documented throughout the study. n = number of infusions|Throughout the duration of each patient's participation in the study (study duration: mean [±SD]: 561 days [±251]; median [range]: 773 days [144-1185]).|The EFF-P population included 25 patients.|||IU/kg per infusion|Number of infusions|Full Range|Median
2657877|NCT01602419|Other Pre-specified|Dosage for Prophylactic Wilate Treatment Per Infusion on a Continuous Basis|"Number and dosage of Wilate infusions administered as prophylactic treatment on a continuous basis were documented throughout the study.~The treatment regimen for prophylactic treatment was at the discretion of the investigator and differed for each patient, as did the duration of prophylactic treatment.~n = number of infusions."|Throughout the duration of each patient's participation in the study (study duration: mean [±SD]: 805 days [±247]; median [range]: 797 days [144-1185]).|Patients receiving prophylactic Wilate (n=17) on a continuous basis (EFF-PC population).|||IU/kg per infusion|Number of infusions|Full Range|Median
2657878|NCT01602419|Other Pre-specified|Dosage for Prophylactic Wilate Treatment on a Continuous Basis|"Number and dosage of Wilate infusions administered as prophylactic treatment on a continuous basis were documented throughout the study.~The treatment regimen for prophylactic treatment was at the discretion of the investigator and differed for each patient, as did the duration of prophylactic treatment.~n = number of patients."|Throughout the duration of each patient's participation in the study (study duration: mean [±SD]: 805 days [±247]; median [range]: 797 days [144-1185]).|Patients receiving prophylactic Wilate (n=17) on a continuous basis (EFF-PC population).|||IU/kg per week||Full Range|Median
2657879|NCT01602419|Other Pre-specified|Number of Infusions Per Week for Prophylactic Wilate Treatment on a Continuous Basis|"Number and dosage of Wilate infusions administered as prophylactic treatment on a continuous basis were documented throughout the study.~The treatment regimen for prophylactic treatment was at the discretion of the investigator and differed for each patient, as did the duration of prophylactic treatment."|Throughout the duration of each patient's participation in the study (study duration: mean [±SD]: 805 days [±247]; median [range]: 797 days [144-1185]).|Patients receiving prophylactic Wilate (n=17) on a continuous basis (EFF-PC population).|||Infusions per week||Full Range|Median
2657880|NCT01602419|Other Pre-specified|Exposure Days for Prophylactic Wilate Treatment on a Continuous Basis|"Number and dosage of Wilate infusions administered as prophylactic treatment on a continuous basis were documented throughout the study.~The treatment regimen for prophylactic treatment was at the discretion of the investigator and differed for each patient, as did the duration of prophylactic treatment."|Throughout the duration of each patient's participation in the study (study duration: mean [±SD]: 805 days [±247]; median [range]: 797 days [144-1185]).|Patients receiving prophylactic Wilate (n=17) on a continuous basis (EFF-PC population).|||Exposure days||Full Range|Median
2657881|NCT01602419|Other Pre-specified|Dosage for Prophylactic Treatment With Wilate Per Infusion|The treatment regimen for prophylactic treatment was at the discretion of the investigator and differed for each patient, as did the duration of prophylactic treatment. The prophylaxis efficacy population (EFF-P) was subdivided into 2 groups, prophylaxis on a continuous basis (EFF-PC population) and prophylaxis on an intermittent basis (EFF-PI population).|Throughout the duration of each patient's participation in the study (study duration: mean [±SD]: 761 days [±251]; median [range]: 773 days [144-1185]).|Patients receiving prophylactic treatment (n=25) on either a continuous basis (EFF-PC population) or an intermittent basis (EFF-PI population).|||IU/kg per infusion|Number of infusions|Full Range|Median
2657882|NCT01602419|Other Pre-specified|Dosage for Prophylactic Treatment With Wilate Per Week|"The treatment regimen for prophylactic treatment was at the discretion of the investigator and differed for each patient, as did the duration of prophylactic treatment. The prophylaxis efficacy population (EFF-P) was subdivided into 2 groups, prophylaxis on a continuous basis (EFF-PC population) and prophylaxis on an intermittent basis (EFF-PI population).~n = number of patients"|Throughout the duration of each patient's participation in the study (study duration: mean [±SD]: 761 days [±251]; median [range]: 773 days [144-1185]).|Patients receiving prophylactic treatment (n=25) on either a continuous basis (EFF-PC population) or an intermittent basis (EFF-PI population).|||IU/kg per week||Full Range|Median
2657883|NCT01602419|Other Pre-specified|Number of Infusions of Prophylactic Treatment With Wilate Per Week|"The treatment regimen for prophylactic treatment was at the discretion of the investigator and differed for each patient, as did the duration of prophylactic treatment. The prophylaxis efficacy population (EFF-P) was subdivided into 2 groups, prophylaxis on a continuous basis (EFF-PC population) and prophylaxis on an intermittent basis (EFF-PI population).~n = number of patients."|Throughout the duration of each patient's participation in the study (study duration: mean [±SD]: 761 days [±251]; median [range]: 773 days [144-1185]).|Patients receiving prophylactic treatment (n=25) on either a continuous basis (EFF-PC population) or an intermittent basis (EFF-PI population).|||Infusions per week||Full Range|Median
2657884|NCT01602419|Other Pre-specified|Exposure Days for Prophylactic Treatment With Wilate|The treatment regimen for prophylactic treatment was at the discretion of the investigator and differed for each patient, as did the duration of prophylactic treatment. The prophylaxis efficacy population (EFF-P) was subdivided into 2 groups, prophylaxis on a continuous basis (EFF-PC population) and prophylaxis on an intermittent basis (EFF-PI population).|Throughout the duration of each patient's participation in the study (study duration: mean [±SD]: 761 days [±251]; median [range]: 773 days [144-1185]).|Patients receiving prophylactic treatment (n=25) on either a continuous basis (EFF-PC population) or an intermittent basis (EFF-PI population).|||Exposure days||Full Range|Median
2657885|NCT01602419|Other Pre-specified|Wilate Doses for the Treatment of Menstrual Bleeding Episodes (BEs)|"Dosage of Wilate administered for treatment of menstrual BE's was documented throughout the study.~n = number of BEs treated"|Throughout the duration of each patient's participation in the study (study duration: mean [±SD]: 553 days [±296]; median [range]: 713 days [125-840]).|Nine patients from the EFF population had a total of 56 menstrual BEs treated with Wilate.|||IU/kg per menstrual BE|Number of menstrual BEs|Full Range|Median
2657886|NCT01602419|Other Pre-specified|Wilate Dosage for the Treatment of Acute Bleeding Episodes (BEs; On-demand) Per Bleeding Episode (BE)|"The dosage of Wilate administered for the on-demand treatment of acute BEs was documented throughout the study.~n = number of BEs"|Throughout the duration of each patient's participation in the study (study duration: mean [±SD]: 677 days [±264]; median [range]: 749 days [40-1052]).|Bleeding episodes (BEs) occurring in the efficacy on-demand (EFF-OD) population that included 25 patients.|||IU/kg per BE|Number of BEs|Full Range|Median
2657887|NCT01602419|Other Pre-specified|Wilate Dosage Per Infusion for the Treatment of Acute Bleeding Episodes (BEs; On-demand)|"The number of infusions and dosage of Wilate administered for the on-demand treatment of acute BEs was documented throughout the study.~n= number of infusions"|Throughout the duration of each patient's participation in the study (study duration: mean [±SD]: 677 days [±264]; median [range]: 749 days [40-1052]).|Bleeding episodes (BEs) occurring in the efficacy on-demand (EFF-OD) population that included 25 patients. Menstrual BEs were excluded from this analysis.|||IU/kg per infusion|Number of infusions|Full Range|Median
2657888|NCT01602419|Other Pre-specified|Safety: Patients With Thrombogenicity Values >2 Times the Upper Limit of Normal (ULN)|Thrombogenicity testing was optional. Thrombogenicity markers (prothrombin fragments 1 + 2; D-dimer) were evaluated at baseline and during follow up. Samples with prothrombin F1+2 and/or D-dimer values at least 2 times above the upper limit of normal were recorded as high.|Optional thrombogenicity tests were performed at baseline and 1, 3 and 24 hours after each administration of Wilate.|A total of 47 patients were assessed over multiple visits. Results were not available at all visits for all patients.|||Participants|||Count of Participants
2657889|NCT01602419|Other Pre-specified|Adverse Drug Reactions (ADRs)|Patients with a positive inhibitor test were assessed for ADRs related to anti VWF antibody or inhibitor development|Optional antibody tests were performed at baseline and 3-4 days (preferable 7 days) after Wilate injection|ADRs were assessed for all patients who has a positive VWF inhibitor testing result as described in outcome 8.|||Adverse drug reactions|||Number
2657890|NCT01602419|Other Pre-specified|Safety: Frequency of VWF Inhibitors at Baseline and Follow up|Optional testing for anti-VWF antibodies/VWF inhibitor was performed at the baseline and follow up visits. VWF inhibitor testing was only performed if anti-VWF antibody results were positive. VWF antibody testing was performed using an ELISA assay, and inhibitor testing using a Bethesda assay. Both assays were considered experimental, since no standardized laboratory assays were available. Results displayed here are for confirmatory inhibitor testing.|Optional antibody tests were performed at baseline and 3-4 days (preferable 7 days) after Wilate injection.|Data was analysed for all patients in the SAF population who underwent VWF inhibitor testing. Results were not available at all visits for all patients.|||Participants|||Count of Participants
2657891|NCT01602419|Other Pre-specified|Safety: Number of Exposure Days to Wilate|"Number of exposure days to Wilate was documented throughout the observation period~EDs = exposure days. IU = international unit. SD = standard deviation."|Throughout the duration of each patient's participation in the study (study duration: mean [±SD]: 575 days [±326]; median [range]: 731 days [2-1185]).|All patients who received at least one dose of Wilate during the study (SAF Population).|||Exposure days||Full Range|Median
2657892|NCT01602419|Secondary|Overall Efficacy Assessment by Patient and Physician at the End of the Treatment Period|Patient and investigator assessment of the overall efficacy of Wilate performed at the end of the study for each patient. Efficacy was rated on a 4-point scale (excellent; good; moderate; none); criteria for assessment were not defined.|At the end of the study for each patient (study duration: mean [±SD]: 596 days [±336]; median [range]: 732 days [2-1185]).|Overall efficacy assessments in the EFF population (n=91) were available from 78 patients, and investigator assessments were available for 86 patients.|||Participants|||Count of Participants
2657893|NCT01602419|Secondary|Efficacy Analysis of Surgical Prophylaxis|Efficacy was rated on a 4-point scale (excellent; good; moderate; none) according to overall haemostasis during and after surgery.|During and immediately after each surgery.|All patients in the EFF population who underwent surgery under the cover of Wilate (efficacy subpopulation undergoing surgery (EFF-S) population), divided according to surgery type. Efficacy assessments were available for 51/52 minor and 46/46 major surgeries.|||Surgeries|Surgeries||Count of Units
2657894|NCT01602419|Secondary|Efficacy Analysis for the Prevention of Breakthrough Bleeds During Prophylaxis|Efficacy was rated on a 4-point scale (excellent; good; moderate; none) according to the number of breakthrough bleeds per month. The treatment regimen for prophylactic treatment was at the discretion of the investigator and differed for each patient, as did the duration of prophylactic treatment. The prophylaxis efficacy population (EFF-P) was subdivided into 2 groups, prophylaxis on a continuous basis (EFF-PC population) and prophylaxis on an intermittent basis (EFF-PI population). In total, 25 patients received Wilate for prophylaxis and of these, 17 patients received prophylaxis on a continuous basis, which was defined as: (1) patients having received continuous prophylaxis over a period of at least 3 months, with no treatment gaps longer than 14 days; or (2) patients having received continuous prophylaxis for at least 1 year with an average of 1 infusion/per week (these patients may have had gaps of more than 14 days).|At the end of the study for each patient (study duration: mean [±SD]: 805 days [±247]; median [range]: 797 days [144-1185]).|The efficacy results for the 17 patients with continuous prophylaxis are described here (EFF-PC population).|||Participants|||Count of Participants
2657895|NCT01602419|Secondary|Patient and Investigator Efficacy Analysis Assessment of the Treatment of Bleeding Episodes (BEs)|"Document the efficacy of Wilate in the treatment of acute BEs, breakthrough BEs in patients receiving prophylactic treatment, and menstrual BEs.~Efficacy was rated on a 4-point scale (excellent; good; moderate; none) according to overall haemostasis."|During and immediately after treatment of each BE.|From all the patients in the EFF population, 58 patients experienced one or more evaluable BEs; 24 patients experienced acute BEs, 25 patients experienced breakthrough BEs and 9 experienced menstrual BEs.|||Bleeding Episodes (BEs)|Bleeding Episodes (BEs)||Count of Units
2657896|NCT01602419|Primary|Tolerability Assessment of Wilate Infusions by Reason for Administration|"Tolerability was assessed using a 3-point verbal rating scale (excellent; satisfactory; unsatisfactory) according to overall feeling during and after Wilate therapy and occurrence of ADRs.~Tolerability was assessed for infusions given for on-demand and prophylactic treatment, but not for infusions administered for surgeries or for the purpose of thrombogenicity assessment. In some instances, however, investigators also recorded the tolerability of infusions given for surgical prophylaxis. For infusions administered for surgeries, only those with available tolerability assessments are presented. Wilate infusion may have been administered to a patient for more than one reason and may be included in more than one category (e.g., if a patient was under Wilate prophylaxis, they could also receive Wilate for the treatment of a bleeding episode [BE] or surgery or menstruation)."|During and immediately after each infusion of Wilate during the study.|The tolerability analysis was performed in the SAF population; however, not all of the 111 participants experienced bleeding or had surgery or menstruation.|||Infusions|Infusions||Count of Units
2657897|NCT01602419|Primary|Incidence of Adverse Drug Reactions (ADRs) (%)|Medical Dictionary for Regulatory Activities (MedDRA) primary system organ class preferred term. Incidence rate = number of patients reporting the event / number of patients * 100|Throughout the duration of each patient's participation in the study (mean [± standard deviation (SD)]: 575 days [±326]; median [range]: 731 days [2-1185])|All patients who received at least one dose of Wilate during the study (SAF population).|||Participants|||Count of Participants
2657898|NCT01602380|Secondary|Comparison of the Effect of Fulvestrant Treatment Versus Anastrozole Treatment on Time to Deterioration of Health Related Quality of Life (HRQoL)|The Functional Assessment of Cancer Therapy - Breast (FACT-B) questionnaire was the instrument selected to assess HRQoL and comprises the following subscales: physical well-being (PWB), functional well-being (FWB), social well-being, emotional well-being, and breast cancer subscale (BCS). The main outcome measure from the FACT-B questionnaire was the Trial Outcome Index (TOI), which was a summary of the following subscales: PWB, FWB, and BCS. Outcome measure is reported as median time to deterioration, defined as the interval from the date of randomisation to the first assessment of worsened without an improvement in the next 12 weeks in FACT-B TOI, or the date of death (by any cause in the absence of symptom deterioration). Time to deterioration as measured by FACT-B total score was derived similarly and is also reported.|Quality of life questionnaires completed at baseline and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).|The ITT analysis set included all randomised patients.|||months||Inter-Quartile Range|Median
2657899|NCT01602380|Secondary|Expected Duration of Clinical Benefit (EDoCB) for Fulvestrant Treatment Versus Anastrozole Treatment|EDoCB was estimated using the formula EDoCB = p Efp(x), where x = EDoCB, p = proportion of responders, and Efp(x) = mean duration of response for responders. The estimation was completed by using the maximum likelihood estimates of p and Efp(x), as described by Ellis (Ellis S et al. Analysis of duration of response in oncology trials, Contemp Clin Trials 2008; 29:456-65).|Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).|The ITT analysis set included all randomised patients.|||Days|||Number
2657900|NCT01602380|Secondary|Duration of Clinical Benefit (DoCB) for Fulvestrant Treatment Versus Anastrozole Treatment|DoCB was defined only for patients who had clinical benefit, as the time in days from date of randomisation until the date of disease progression.|Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).|Only patients in the ITT analysis set (which included all randomised patients) who also had a clinical benefit were included in the DoCB analysis (n=180 for Fulvestrant arm and n=172 for Anastrozole arm).|||Months||Inter-Quartile Range|Median
2657901|NCT01602380|Secondary|Clinical Benefit Rate (CBR) for Fulvestrant Treatment Versus Anastrozole Treatment|CBR was defined as the percentage of patients who had a clinical benefit (i.e. best objective response of CR, PR or stable disease), that was maintained for at least 24 weeks, prior to any evidence of progression. Note that a minimum duration of 22 weeks for CBR was applicable in the analysis (rather than 24 weeks) to allow for the protocolled window of +/-2 weeks.|Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).|The ITT analysis set included all randomised patients.|||Percentage of participants|||Number
2657902|NCT01602380|Secondary|Expected Duration of Response (EDoR) for Fulvestrant Treatment Versus Anastrozole Treatment|EDoR was estimated using the formula EDoR = p Efp(x), where x = DoR, p = proportion of responders, and Efp(x) = mean duration of response for responders. The estimation was completed by using the maximum likelihood estimates of p and Efp(x), as described by Ellis (Ellis S et al. Analysis of duration of response in oncology trials, Contemp Clin Trials 2008; 29:456-65).|Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).|EDoR analysis was based on the number of patients in the ITT analysis set (which included all randomised patients) who had measurable disease at baseline (n=193 for Fulvestrant arm and n=196 for Anastrozole arm).|||Days|||Number
2657903|NCT01602380|Secondary|Duration of Response (DoR) for Fulvestrant Treatment Versus Anastrozole Treatment|DoR was defined only for patients who had an objective response, as the time in days from date of first documentation of response (CR/PR) until date of disease progression.|Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off)..|Only patients in the ITT analysis set (which included all randomised patients), who also had an objective response and had measurable disease at baseline were included in the DoR analysis (n=89 for Fulvestrant arm and n=88 for Anastrozole arm).|||Months||Inter-Quartile Range|Median
2657904|NCT01602380|Secondary|Objective Response Rate (ORR) for Fulvestrant Treatment Versus Anastrozole Treatment|ORR was defined as the percentage patients with an objective response (i.e. those recording a partial response [PR] or complete response [CR]) at some point during the study, prior to disease progression. ORR was assessed in patients with measurable disease at baseline only. The determination of measurable disease at baseline was done using baseline RECIST data.|Baseline RECIST 1.1 assessments and then every 12 weeks until disease progression or treatment discontinuation (up to approximately 38 months for the primary analysis data cut-off).|Percentages for ORR were calculated based on the number of patients in the ITT analysis set (which included all randomised patients) who had measurable disease at baseline (n=193 for Fulvestrant arm and n=196 for Anastrozole arm).|||Percentage of participants|||Number
2657905|NCT01602380|Secondary|Comparison of Overall Survival (OS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole; Percentage of Patients With Events|OS was defined as the time from randomisation until death by any cause. Two timepoints were planned for OS analysis: an interim OS analysis at the time of the data cut-off for PFS analysis and a final OS analysis when 75% of the deaths have occurred. The current OS data correspond to that of the interim analysis only and the outcome measure is reported as percentage of patients with events.|Baseline up to data cut-off for PFS analysis (up to approximately 38 months). Following disease progression, patients were to be contacted at 12 weekly intervals to to determine survival status.|The ITT analysis set included all randomised patients.|||Percentage of participants|||Number
2657906|NCT01602380|Primary|Comparison of Progression Free Survival (PFS) in Patients Treated With Fulvestrant With Those Treated With Anastrozole|PFS was defined as the time from randomisation until objective disease progression according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1), surgery or radiotherapy to manage worsening of disease or death by any cause (in the absence of progression). Outcome measure is reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique.|Baseline RECIST 1.1 assessments and then every 12 weeks until the earliest of disease progression evident, patient dies or has surgery/radiotherapy for their disease (up to approximately 38 months for the primary analysis data cut-off).|The ITT analysis set included all randomised patients.|||Months||95% Confidence Interval|Median
2657907|NCT01602341|Secondary|Improvement From Baseline in ADSI Component Scores (Erythema, Pruritus, Exudation, Excoriation and Lichenification) at Day 8, 15, 22 and 29|ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from baseline was calculated as baseline evaluation minus the follow-up evaluation.|Baseline, Day 8, 15, 22, 29|ITT population included all participants who were randomized and received study drug.|||units on a scale||Standard Deviation|Mean
2668021|NCT01509677|Secondary|Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (MCP-1 (pg/mL))||Baseline to 14 weeks||||pg/mL||Standard Error|Least Squares Mean
2657909|NCT01602341|Secondary|Number of Participants With Treatment-Emergent Adverse Events By Severity|AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed on basis of severity as follows: mild=does not interfere with participant's usual function; moderate=interferes to some extent with participant's usual function; severe=interferes significantly with participant's usual function. Number of participants with mild, moderate and severe treatment-emergent AEs were reported in this outcome measure.|Baseline up to Day 29|Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.|||Participants|||Count of Participants
2657910|NCT01602341|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study treatment (Day 29), that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to Day 29|Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.|||Participants|||Count of Participants
2657911|NCT01602341|Secondary|Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities|Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]). Clinical significance of laboratory parameters was determined at the investigator's discretion.|Baseline up to Day 29|Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.|||Participants|||Count of Participants
2657912|NCT01602341|Secondary|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion.|Baseline up to Day 29|Safety population included all participants who were randomized and applied at least 1 confirmed dose of study drug.|||Participants|||Count of Participants
2657913|NCT01602341|Primary|Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 29|ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.|Baseline, Day 29|ITT population included all participants who were randomized and received study drug.|||units on a scale||Standard Deviation|Mean
2657914|NCT01602341|Primary|Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 22|ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.|Baseline, Day 22|ITT population included all participants, who were randomized and received study drug.|||units on a scale||Standard Deviation|Mean
2657915|NCT01602341|Primary|Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 15|ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.|Baseline, Day 15|ITT population included all participants who were randomized and received study drug.|||units on a scale||Standard Deviation|Mean
2657916|NCT01602341|Primary|Improvement From Baseline in Atopic Dermatitis Severity Index (ADSI) Score at Day 8|ADSI was used to assess the severity of atopic dermatitis (AD) based on five subscale scores of erythema, pruritus, exudation, excoriation, and lichenification. The severity of each subscale was measured on a 4-point scale ranging from 0 (none) to 3 (severe), where higher scores indicating more severity. ADSI was calculated as the sum of these 5 subscale scores with a total possible score range of 0 (none) to 15 (most severe) where, higher scores indicating more severity. Improvement from Baseline was calculated as Baseline score minus follow-up score.|Baseline, Day 8|ITT population included all participants who were randomized and received study drug.|||units on a scale||Standard Deviation|Mean
2657917|NCT01602315|Secondary|Phase II: Progression Free Survival (PFS) Based on Investigator's Assessment With Treatment|Assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab|approximately 6 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||Days||95% Confidence Interval|Median
2657918|NCT01602315|Secondary|For Phase II: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities|Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm 1, 2 and 2B.|baseline, post baseline during the entire study period (approximately 1 year)|Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.|||Participants|||Number
2657920|NCT01602315|Secondary|Phase Ib: Number of Patients With Notable Electrocardiogram (ECG) Abnormalities|Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm A, B and C.|baseline, post baseline|Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.|||Participants|||Number
2657921|NCT01602315|Secondary|Phase Ib: Notable Abnormal Vital Signs by Treatment|Characterization of the safety and tolerability of BYL719 in combination with cetuximab in arm A, B and C.|approximately 6 months|Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.|||Participants|||Number
2657922|NCT01602315|Secondary|Phase Ib: Tmax for BYL719 After Continuous Dose Administration (Steady State)|Non compartmental PK parameters derived after single dose at Cycle 1 Day 1|Day 1 Cycle 1|Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.|||hr||Full Range|Median
2657923|NCT01602315|Secondary|Phase Ib: Cmax for BYL719 After Continuous Dose Administration (Steady State)|Non compartmental PK parameters derived after single dose at Cycle 1 Day 1|Day 1 Cycle 1|Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.|||ng/mL||Full Range|Median
2657924|NCT01602315|Secondary|Phase Ib: Plasma Pharmacokinetic Parameters for BYL719 After Continuous Dose Administration (Steady State)|Non compartmental PK parameters derived after single dose at Cycle 1 Day 1|Day 1 Cycle 1|Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.|||hr*ng/mL||Full Range|Median
2657925|NCT01602315|Secondary|Phase Ib: Tmax for BYL719 by Treatment|Non compartmental Cmax derived after single dose at Cycle 1 Day 1|Day 1 Cycle 1|Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.|||hr||Full Range|Median
2657926|NCT01602315|Secondary|Phase Ib: Cmax for BYL719 by Treatment|Non compartmental Cmax derived after single dose at Cycle 1 Day 1|Day 1 Cycle 1|Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.|||ng/mL||Full Range|Median
2657927|NCT01602315|Secondary|Phase Ib: Primary Plasma Pharmacokinetic Parameters for BYL719 by Treatment|Non compartmental PK parameters derived after single dose at Cycle 1 Day 1|1 to 24 hours post dose (Day 1 Cycle 1)|Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.|||hr*ng/mL||Full Range|Median
2657928|NCT01602315|Secondary|Phase II, Scheme 2 (Arm 2B): Overall Survival (OS) for the Cross-over|Phase II, Scheme 1 (Arm 2B): To further assess the anti-tumor activity of BYL719 + cetuximab in the setting of resistance to single agent cetuximab.|approximately 1 year|Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.|||Days||95% Confidence Interval|Median
2657929|NCT01602315|Secondary|Phase II, Scheme 1 (Arm 2B): Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1|"Phase II: Scheme 1 (Arm 2B): To further assess the anti-tumor activity of BYL719 + cetuximab in the setting of resistance to single agent cetuximab.~Complete response (CR); Partial response (PR); Stable disease (SD)"|Approximately 6 months|Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.|||Rate||95% Confidence Interval|Number
2657930|NCT01602315|Secondary|For Phase Ib: Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1|"Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arm A, B and C~CR=complete response PR=partial response"|approximately 6 months|Safety Analysis Set (SAS) consisted of all patients from the FAS who received at least one dose of BYL719 or the standard cetuximab therapy and had at least one post -baseline safety assessment.|||Percentages||95% Confidence Interval|Number
2657931|NCT01602315|Secondary|Phase II: Non-Randomized Overall Survival (OS) by Treatment|Scheme 1 (Arm 3): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab|approximately 1 year|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||Patients|||Number
2657932|NCT01602315|Secondary|Phase II: Randomized Overall Survival (OS) by Treatment|Scheme 1 (Arms 1 and 2): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab|approximately 1 year|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||Patients|||Number
2657933|NCT01602315|Secondary|Phase II: Non-Randomized Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1|Scheme 1 (arm 3): Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arm 3 (non-randomized arm)|approximately 6 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||Percentages||95% Confidence Interval|Number
2657934|NCT01602315|Secondary|Phase II: Randomized Overall Response Rate (ORR) and Disease Control Rate (DCR) as Per RECIST v1.1|Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arms 1 and 2.|approximately 6 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||Percentages||95% Confidence Interval|Number
2658885|NCT01593787|Secondary|Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8|Successful response rate was defined as msDBP <80 mmHg or a reduction of ≥10 mmHg from baseline.|8 weeks|FAS|||Percentage of participants|||Number
2657935|NCT01602315|Secondary|Phase II: Non-Randomized Best Overall Response as Per RECIST v1.1|Scheme 1 (Arm 3): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab|approximately 6 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||Participants|||Number
2657936|NCT01602315|Secondary|Phase II: Randomized Best Overall Response as Per RECIST v1.1|Scheme 1 (Arms 1 and 2): Further assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab|approximately 6 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||Participants|||Number
2657937|NCT01602315|Secondary|Phase Ib: Progression Free Survival (PFS) as Per RECIST v1.1|Assessment of the preliminary anti-tumor activity of BYL719 in combination with cetuximab in arm A, B and C.|approximately 6 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||Participants|||Number
2657938|NCT01602315|Secondary|Phase II: Progression Free Survival (PFS) as Per RECIST v 1.1|Phase II, Scheme 1 (Arm 2B): To further assess the anti-tumor activity of BYL719 + cetuximab in the setting of resistance to single agent cetuximab|approximately 6 months|Full analysis Set (FAS) consisted of those patients who, after crossing over had received at least one dose of BYL719.|||Participants|||Number
2657939|NCT01602315|Primary|Phase Ib: Area Under Curve (AUC) 0-24 for BYL719 by Treatment|Comparison of single-dose exposure of BYL719 dispersible tablet via G-tube in combination with cetuximab in RM HNSCC to that of Arm A (film-coated tables)|6 months|Pharmacokinetic Analysis Set (PAS) consisted of all patients who had at least one blood sample providing evaluable PK data. The PAS was used for summaries of PK data as well as for listings of derived parameters.|||hr*ng/mL||Full Range|Median
2657940|NCT01602315|Primary|Phase II Arm 3: Progression Free Survival (PFS) as Per RECIST V1.1|Assessment of the anti-tumor activity of BYL719 in combination with cetuximab in patients resistant to platinum-based therapy and cetuximab.|approximately 6 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||months||95% Confidence Interval|Median
2657941|NCT01602315|Primary|Phase II Arms 1 and 2: Progression Free Survival (PFS) as Per RECIST v1.1 by Central Radiology Review|"Assessment of the anti-tumor activity of BYL719 in combination with cetuximab vs. cetuximab as single-agent in RM HNSCC patients naive to cetuximab.~6 months is an approximate timeframe."|approximately 6 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of either BYL719 or Cetuximab in Phase Ib and Phase II Arm 3, and all randomized patients in Phase II Scheme 1, Arm 1 and Arm 2.|||participants|||Number
2657942|NCT01602315|Primary|For Phase Ib: Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1 (28 Days)|"Estimation of Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) in arm A (BYL719 administered as a whole tablet in patients able to swallow the tablets) and arm B (BYL719 administered as a drinkable suspension in patients with swallowing dysfunction).~6 months is an approximate timeframe."|until disease progression or intolerable toxicity (approximately 6 months)|Dose Determining Analysis Set (DDS) consisted of all patients from the SAS who met the requirements for minimum safety evaluation and minimum exposure or experienced DLT during Cycle 1. This analysis set was defined only for the Phase Ib patients.|||Participants|||Number
2657943|NCT01602315|Primary|Phase Ib Arm B: Probability That Distribution of Dose Limiting Toxicities (DLTs) is in the Recommended Phase 2 Dose in Cycle 1 (Cycle 1=28 Days)|Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) in arm B (crushed film-coated tablets as an oral suspension with swallowing dysfunction). Dose recommendation was based on posterior summaries including the mean, median, standard deviation, 95%-credibility interval, and the probability that the true DLT rate for each dose combination lies in one of the following categories: (0%, 16%) under-dosing; (16%, 35%) targeted toxicity; (35%, 100%) excessive toxicity. The combination treatment was considered superior to cetuximab alone if the posterior probability (HR > 1) < 10%, and the posterior median HR < 0.7.|until disease progression or intolerable toxicity (approximately 6 months)|Dose Determining Analysis Set (DDS) consisted of all patients from the SAS who met the requirements for minimum safety evaluation and minimum exposure or experienced DLT during Cycle 1. This analysis set was defined only for the Phase Ib patients.|||Probability of DLT rate|||Number
2657944|NCT01602315|Primary|Phase Ib Arms A: Probability That Dose Limiting Toxicities (DLTs) Rate is in the Recommended Phase 2 Dose in Cycle 1 (Cycle 1=28 Days)|Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) in arm A (BYL719 administered as a whole tablet in patients able to swallow the tablets). Dose recommendation was based on posterior summaries including the mean, median, standard deviation, 95%-credibility interval, and the probability that the true DLT rate for each dose combination lies in one of the following categories: (0%, 16%) under-dosing; (16%, 35%) targeted toxicity; (35%, 100%) excessive toxicity. The combination treatment was considered superior to cetuximab alone if the posterior probability (HR > 1) < 10%, and the posterior median HR < 0.7.|until disease progression or intolerable toxicity (approximately 6 months)|Dose Determining Analysis Set (DDS) consisted of all patients from the SAS who met the requirements for minimum safety evaluation and minimum exposure or experienced DLT during Cycle 1. This analysis set was defined only for the Phase Ib patients.|||Probability of DLT rate|||Number
2657945|NCT01602224|Secondary|Overall Response Rate (ORR)|Overall Response Rate (ORR) is the percentage of participants that had a response.|Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (28 Months)|All randomized participants who had a partial response or greater.|||percentage of participants|||Number
2658886|NCT01593787|Secondary|Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8|Successful response rate was defined as msSBP <130 mmHg or a reduction of ≥20 mmHg from baseline|8 weeks|FAS|||Percentage of participants|||Number
2657946|NCT01602224|Secondary|Number of Participants With a Given Best Objective Myeloma Response (Quality of Response [QoR])|Response categories in order of decreasing quality are: Stringent Complete Response(sCR),Complete Response(CR), Very Good Partial Response(VGPR),Partial Response(PR),Minimal Response(MR),Stable Disease(SD), or Progressive Disease(PD), according to the International Uniform Response Criteria for Multiple Myeloma.SCR:normal free light chain ration and no clonal cells in bone marrow;CR-no monoclonal protein(mp) in blood, no serum/urine,<5% plasma cells in bone marrow; VGPR-more than 90% decrease in mp and urine protein; PR->50% decrease in serum MP;SD-<25% decrease in mp; PD-25% increase compared to lowest value of serum mp, urine mp and no measurable mp.|Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (up to 28 Months)|All randomized participants.|||participants|||Number
2657947|NCT01602224|Secondary|Participants With Best Overall Response (BOR) in Each Category|Stringent Complete Response-Complete Response and normal free light chain ration and no clonal cells in bone marrow Complete Response- no monoclonal protein (mp) in blood, no serum or urine mp, less than 5% plasma cells in bone marrow Very Good Partial Response-more than 90% decrease in mp and urine protein Partial Response- over 50% decrease in serum mp Stable Disease- less than 25 percent decrease of monoclonal protein Progressive Disease- 25% increase compared to lowest value of serum mp, urine mp, no measurable mp|Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (28 Months)|All randomized participants.|||Participants|||Count of Participants
2657948|NCT01602224|Secondary|Number of Participants Developing Anti-tabalumab Antibodies||Baseline through Cycle 8|Zero participants analyzed, no data collected due to compound termination.||||||
2657949|NCT01602224|Secondary|PK: Area Under the Curve Over the Dosing Interval (AUC-T) for Tabalumab||C1 D1: Predose, 3O minutes, 2 hours Postdose; C1 D4, 8, 11: Predose, (D11 only, 30 minutes Postdose); C2 and C6-C10 D1: Predose and immediately Postdose; C2 D 4, 8, 11: Anytime|All randomized participants who received at least 1 dose of study drug and had evaluable PK parameters.|||micrograms times hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2657950|NCT01602224|Secondary|PK: Time to Maximum Plasma Concentration (Tmax) of Tabalumab||C1 D1: Predose, 3O minutes, 2 hours Postdose; C1 D4, 8, 11: Predose, (D11 only, 30 minutes Postdose); C2 and C6-C10 D1: Predose and immediately Postdose; C2 D 4, 8, 11: Anytime|All randomized participants who received at least 1 dose of study drug with evaluable PK values.|||hours||95% Confidence Interval|Mean
2657951|NCT01602224|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab|Maximum Concentration (Cmax) of Tabalumab.|Cycle (C)1 Day (D)1: Predose, 3O minutes, 2 hours Postdose; C1 D4, 8, 11: Predose, (D11 only, 30 minutes Postdose); C2 and C6-C10 D1: Predose and immediately Postdose; C2 D 4, 8, 11: Anytime|All randomized participants who received at least 1 dose of study drug and evaluable PK data.|||micrograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2657952|NCT01602224|Secondary|Time to Next Treatment (TNT)|TNT is defined as the time from the date of randomization to the date of initiation of the first poststudy treatment course of anticancer therapy or death from any cause. Time to next treatment will be censored at the date of the last visit for participant who did not initiate additional anticancer therapy.|Baseline to Initiation of New Cancer Treatment or Death From Any Cause (18 Months)|All randomized participants.|||months||95% Confidence Interval|Median
2657953|NCT01602224|Secondary|Duration of Response (DoR)|DOR is measured by the International Myeloma Working Group Uniform Response Criteria: from the date of first evidence of a confirmed response to the date of objective progression or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, the DOR time will be censored at the last complete objective progression-free disease assessment date. Progressive disease is an increase of 25% from baseline in Serum M, Urine M, bone marrow plasma cell increase of 10 %, development of new bone lesions, development of new soft tissue plasmacytomas or bone lesions, hypercalcemia >11.5 milligrams per deciliter, decrease in hemoglobin of 2 grams per deciliter, rise in serum creatinine by 2 mg/deciliter.|Time from Response to Objective Disease Progression (assessed up to 38 months)|All randomized participants who received at least 1 dose of study drug and had a response.|||months||95% Confidence Interval|Median
2657954|NCT01602224|Secondary|Time to Progression (TTP)|Time to progression is defined as the time from the date of randomization to the date of first observed objective progression or death due to study disease. Time to progression will be censored as for PFS for those participants not known to have progressed or that died from other causes.|Baseline to Objective Disease Progression or Death (assessed up to 9 months)|All randomized participants, with 79 participants censored.|||months||95% Confidence Interval|Median
2657955|NCT01602224|Secondary|Number of Participants With >30% Reduction in Brief Pain Inventory (BPI) - Worst Pain Score|"BPI is assessed by 7 questions rated 0 for no pain and higher numbers indicated more pain."|Baseline through End of Treatment (19 months)|All randomized participants.|||Participants|||Count of Participants
2657956|NCT01602224|Secondary|Time to First Skeletal-Related Event (SRE)|Time to first SRE is defined as time from randomization to any one of the following related to multiple myeloma: New Pathological Fracture, Spinal Cord Compression, Surgery to the Bone, Radiation to the Bone collected until participant death, study closure or lost to follow up. Participants not known to have had an SRE at the time of the analysis were censored at the date of their last complete documented assessment for SRE.|Baseline to Date of First Skeletal Related Event (assessed up to 19 months)|All randomized participants.|||months||95% Confidence Interval|Median
2657957|NCT01602224|Secondary|Overall Survival|Overall survival is the duration from enrollment to death from any cause. For participants who were alive, overall survival was censored at the last contact.|Baseline to Death From Any Cause (assessed up to 19 months)|All randomized participants.|||months||95% Confidence Interval|Median
2657969|NCT01602016|Primary|Language Improvement|Language (measured by the receptive and expressive CELF language index, and preschool language scale (PLS), as needed) will be the primary outcome for the study. Both preliminary studies have suggested that the folinic acid intervention will be associated with receptive and expressive language improvements.|(baseline and 12 weeks )|The study sponsor (UAMS) was unable to completely monitor the study or resolve outstanding queries. The study data cannot be fully validated by the sponsor. The study was placed on Full Clinical Hold by the FDA and terminated by the sponsor as a result of investigator non-compliance.||||||
2657970|NCT01601977|Secondary|Exacerbation Frequency|patient reported exacerbations following 6 weeks of device usage|6 weeks||||exacerbations|||Number
2657958|NCT01602224|Primary|Progression Free Survival (PFS)|PFS is defined as the time from date of first dose to the first observation of disease progression or death due to any cause. If a participant does not have a complete baseline disease assessment, then the PFS time is censored at the enrollment date, regardless of whether or not objectively determined disease progression (Increase of > 25% from lowest response in serum M component, urine M component, bone marrow plasma cell percentage, development of bone lesions) or death has been observed for the participant. If a participant is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time is censored at the last complete objective progression-free disease assessment date.|Baseline up to Objective Disease Progression or Death From Any Cause (assessed up to 9 months)|All randomized participants.|||months||95% Confidence Interval|Median
2657959|NCT01602198|Primary|Change in BOLD Response on Functional Magnetic Resonance Imaging (fMRI)||baseline and 6 months|Trial was terminated prematurely after enrollment of only 1 participant. Sample size is insufficient for BOLD response analysis.||||||
2657960|NCT01602172|Other Pre-specified|Number of Participants Who Were Interested and Motivated to Change Their Alcohol Consumption|Among Veterans randomized to Arm 1, we will analyze the transcripts of Part I of the audio-recorded brief intervention. Descriptive statistics (e.g., frequency distributions, measures of central tendency) will be used to characterize the anonymous sociodemographic, educational, and patient care characteristics of the participants. Transcript data will be analyzed using the grounded theory technique of constant comparison. Similar or related codes will be collapsed into focused codes in order to represent interrelationships, variations, and underlying patterns in the data, allowing for the identification of factors, issues, and themes related to Veterans interest and motivation for changing their alcohol consumption.|Baseline|Data were not collected from the Attention Control and Control Groups|||Participants|||Count of Participants
2657961|NCT01602172|Secondary|Adverse Consequences of Alcohol Use|We will assess adverse consequences of alcohol use with the Short Inventory of Problems (SIP-2R), a widely used 15-item stand-alone short version of the Drinker Inventory of Consequences (DrInC).The SIP-2R will be administered at baseline (for BI and Attention Control) and at 6 months post-hospital discharge (all groups) to assesses adverse consequences of alcohol use over the past three months in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. The SIP-2R was used as a continuous measure with possible scores from 0-45, where each item has a score from 0-3 (0=Never, 1=once or a few times, 2=once or twice a week, 3=daily or almost daily). Higher scores indicate a worse outcome.|6 months|Participants the completed the 6 month interview|||units on a scale||Standard Deviation|Mean
2657962|NCT01602172|Secondary|Readiness to Change Drinking Behavior|We will assess readiness to change with the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES), Version 8.This instrument was created by one of the initial developers of Motivational Interviewing, the therapeutic style on which SBIRT is based. SOCRATES is a 19-item instrument with 3 subscales where minimum score is 19 and the maximum score is 95. Lower totals representing lesser readiness/eagerness for change and higher totals representing greater readiness/eagerness to change. With the three sub scales (Recognition, Ambivalence, and Taking Steps), higher scores indicate greater recognition, ambivalence and taking steps and scores range from 7 to 35, 4 to 20, and 8 to 40, respectively.|6 months|Individuals that completed the 6 month interview|||units on a scale||Standard Deviation|Mean
2657963|NCT01602172|Secondary|Number of Binge Drinking Episodes Over Past 30 Days|Number of Binge Drinking Episodes will be assessed through a third NIAAA question during the recruitment and screening processes: (3) How many times in the past 30 days have you had 5 or more standard-sized drinks in a day (men), or 4 or more standard-sized drinks in a day? (women)|6 months|Participants the completed the 6 month interviews|||binge drinking episodes||Standard Deviation|Mean
2657964|NCT01602172|Secondary|Alcohol Screening Status|Alcohol Screening Status will be assessed using the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) (Appendix 2), the 3-item short form of the 10-item Alcohol Use Disorders Identification Test (AUDIT) developed by the World Health Organization. AUDIT-C data will be collected during the recruitment and screening processes. AUDIT-C scores range from 0-12, with higher values representing a worse outcome (a score of 4 indicating hazardous drinking in males and 3 hazardous drinking in females).Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.|6 months|Only participants that completed the 6 month interview|||units on a scale||Standard Deviation|Mean
2657965|NCT01602172|Primary|Number of Standard Drinks Per Week|"Number of Drinks per Week was determined by the product of responses to the following two NIAAA questions during the recruitment and screening processes : (1) On average, how many days a week do you have an alcoholic drink?; (2) On a typical drinking day, how many standard-sized drinks do you have? (Appendix 2). Standard-sized drink will refer to 12 ounces beer, 5 ounces wine, or 1.5 ounces liquor/spirits."|6 months|Reflects number of participant that completed the 6 month interview|||days/week drink * amt of drinks in day||Standard Deviation|Mean
2657966|NCT01602120|Primary|Percentage of Participants With Ocular and Non-ocular Adverse Events (AEs)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are events localized to the eye. Non-ocular events include all other events.|From Day 1 up to the last study visit (up to approximately 62 months)|Safety population included all participants who were enrolled and received at least one lampalizumab injection in the extension study.|||percentage of participants|||Number
2657967|NCT01602068|Primary|Percentage of Subjects With AC Cell Count of Zero on Day 7|Percentage of patients with anterior chamber (AC) cell count of zero on Day 7 as compared between the active and placebo groups|At Day 7 (plus or minus two days) following the study treatment|This was an exploratory study and therefore a number of efficacy and safety parameters were evaluated. In all measures there was no significant difference between the active and non-active arms.|||Participants|||Count of Participants
2657968|NCT01602016|Secondary|Improved Stereotyped Behavior and Improved Social Skills|Stereotyped behavior (as measured by the OACIS (not at 6 weeks), ASQ, RBS-R, and ABC) and social skills (as measured by the Vineland (not at 6 weeks), ASQ, and SRS) will be the secondary outcomes.|(baseline, 6, and 12 weeks)|No data because no patients were analyzed.||||||
2657971|NCT01601977|Secondary|Exercise Capacity|6 minute walk test|6 weeks|1 patient declined to complete the walking test|||m||Standard Deviation|Mean
2657978|NCT01601873|Secondary|Quality of Life (QoL) Comparison|Comparative assessment of quality of life reported by the patients in two arms|Participants would be followed for a period of 2 years after graft placement|Qol data was collected, but because results of a planned interim futility analysis did not meet the study criteria for continuation, we do not believe analysis of the QoL data would be meaningful. Analysis of QoL data is an extremely onerous process that would take months to conduct. It is not worth the resources required to perform this analysis.||||||
2657979|NCT01601873|Secondary|Cost Estimation and Analysis|Will be based on the difference between total cost analysed on the basis of the specific graft price, cost of re-intervention procedures if any, treatment of complications, hospital stay, etc., and compared for each study arm.|During the study period based on an average participant follow-up of 2 years after graft placement|The cost data were not collected.||||||
2657980|NCT01601873|Secondary|Number of Participants With Complications or Morbidity Attributable to the Study|Complication/morbidity associated with both types of interventions|at least 1 year but up to two years|2 in the propaten group and 3 in the standard graft group were lost to follow up.|||Participants|||Count of Participants
2657981|NCT01601873|Primary|Secondary Graft Patency Rate|Secondary graft patency is defined as a functional access following intervention for thrombosis or after any interposition grafting for any reason including stenosis, aneurysm or pseudoaneurysm.|24 months after graft placement|2 in the propaten group and 3 in the standard graft group were lost to follow up.|||Percentage of participants|||Number
2657982|NCT01601873|Primary|Primary-Assisted Graft Patency Rate|Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention.|24 months after graft placement|2 in the propaten group and 3 in the standard graft group were lost to follow up.|||Percentage of participants|||Number
2657983|NCT01601873|Primary|Primary Graft Patency Rate|Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.|24 months after graft placement|2 in the propaten group and 3 in the standard graft group were lost to follow up.|||Percentage of participants|||Number
2657984|NCT01601873|Primary|Secondary Graft Patency Rate|Secondary graft patency is defined as a functional access following intervention for thrombosis or after any interposition grafting for any reason including stenosis, aneurysm or pseudoaneurysm.|12 months|1 in the propaten arm and 3 in the standard graft arm were lost to follow up.|||Percentage of participants|||Number
2657985|NCT01601873|Primary|Primary-Assisted Graft Patency Rate|Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention.|12 months|1 in the propaten arm and 3 in the standard graft arm were lost to follow up.|||Percentage of participants|||Number
2657986|NCT01601873|Primary|Primary Graft Patency Rate|Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.|12 months|1 in the propaten arm and 3 in the standard graft arm were lost to follow up.|||Percentage of participants|||Number
2657987|NCT01601847|Secondary|Bone Density|Measured by bone speed of sound (ultrasound)|Measured at the 12 month adjusted age visit|Bone density was not performed if (1) infant could not come to the clinic for their 12 month visit and the visit was done in the home (2) they missed their 12 month visit (3) the ultrasound was under repair, or (4) infant could not participate with the ultrasound to get a sufficient quality reading.|||m/s||Full Range|Median
2657988|NCT01601847|Secondary|Number With Infants With Allergic Sensitization as Measured by the PhadiaTop Infant Assay|Measured using the Phadiatop Infant IgE panel|Measured at the 12 month adjusted age visit|Positive result is >0.35 U/L PAU/l|||Participants|||Count of Participants
2657989|NCT01601847|Primary|Number of Infants With Recurrent Wheezing|Recurrent wheezing was defined as more than 1 episode of wheezing reported during the study period. Separate episodes were defined as occurring at least 2 weeks apart.|up to 12 months adjusted age|Infants that were withdrawn, completely lost to follow-up, who died, or for whom recurrent wheezing status was indeterminate due to a missing 12 month visit (n=8) were not included in the primary analysis.|||Participants|||Count of Participants
2657990|NCT01601821|Secondary|Number of Participants Who Discontinued|Number of participants who discontinued the study treatment due to any reason is reported.|Month 12|Analysis population included all participants enrolled in the study.|||participants|||Number
2657991|NCT01601821|Secondary|Incidence of Anemia|Diagnostic criterion for anemia was based on the laboratory results; in men: hemoglobin (Hb) <14 gram per deciliter (g/dL), hematocrit (Hct) <42%, or red blood cells (RBCs) <4.5 million/liter (million/L); for women: Hb <12 g/dL, Hct <37%, or RBC < 4 million/L. Percentage of participants with anaemia was reported.|Baseline up to Month 12|Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
2657992|NCT01601821|Secondary|Percentage of Participants With Efficacy Failure or Premature Elimination|Efficacy failure was defined as the first occurrence of acute rejection, graft loss, or death. Premature elimination was defined as elimination from the study for any other reason.|Month 12|Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
2657993|NCT01601821|Secondary|Incidence of Histologically Confirmed Lymphoproliferative Disease|Lymphoproliferative disorder represents an abnormal proliferation of B cells in response to either primary or reactivated infection with Epstein-Barr virus. Percentage of participants with histologically confirmed lymphoproliferative disease was reported.|Baseline up to Month 12|Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
2657994|NCT01601821|Secondary|Incidence of Presumptive or Documented Infection|Presumptive or documented infection during the 12 months after transplantation; was confirmed by culture, biopsy, or serology and reported. Percentage of participants with presumptive or documented infection was reported.|Baseline up to Month 12|Analysis population included all participants enrolled in the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
2658887|NCT01593787|Secondary|Percentage of Participants Achieving DBP Control at Week 8|DBP control was defined as msDBP <80 mmHg.|8 weeks|FAS|||Percentage of participants|||Number
2657995|NCT01601821|Secondary|Percentage of Participants With Graft Survival|Graft survival defined as those participants who did not experience graft loss. Graft loss defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 weeks), retransplant or death during the first 12 months after randomization.|Month 12|PP4 population included all participants who had completed study, also included those who dropped out of the study due to the occurrence of graft loss.|||percentage of participants|||Number
2657996|NCT01601821|Secondary|Percentage of Participants Who Survived|Survival defined as participants living with or without a functioning graft.|Month 12|PP3 population included all participants who had completed study, also included those who dropped out of the study due to the occurrence of death.|||percentage of participants|||Number
2657997|NCT01601821|Secondary|Histologic Grade of First Acute Rejection|Diagnosis of acute rejection was made via kidney biopsy. Categorization of biopsies with suspected acute rejection was based on histological findings using updated 1997 Banff criteria. Grade 1A: cases with significant interstitial infiltration (>25% of parenchyma affected) and foci of moderate tubulitis (5-10 cells/tubular cross section), Grade 1B: with severe tubulitis (>10 cells/tubular cross section), Grade 2A: mild-moderate intimal arteritis, Grade 2B: severe intimal arteritis and Grade 3: transmural arterits and/or fibrinoid necrosis. Data is reported as percentage of participants.|Baseline up to Month 12|PP2 population included all participants who had completed study, also included those who dropped out of the study due to biopsy confirmed acute rejection at Month 6. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
2657998|NCT01601821|Secondary|Incidence of Biopsy-Confirmed Acute Rejection|Diagnosis of acute rejection was made via kidney biopsy using Banff criteria. Percentage of participants with biopsy-confirmed acute rejection was reported.|Baseline up to Month 6|PP2 population included all participants who had completed study, also included those who dropped out of the study due to biopsy confirmed acute rejection at Month 6.|||percentage of participants|||Number
2657999|NCT01601821|Secondary|Glomerular Filtration Rate (GFR) by Nankivell Method|GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR was calculated using the Nankivell formula. GFR by Nankivell equation= (6.7 per serum creatinine) plus (0.25*body weight) minus (0.5*serum urea) minus (100 per height square) plus (35 for male or 25 for female). A normal GFR is greater than (>)90 mL/min per 1.73 m^2 [mL/min/1.73 m^2], although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (<)15 mL/min/1.73 m^2 indicated kidney failure.|Month 3, 6, 12|PP1 population. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is number of participants evaluable at specific time points for each arm group.|||mL/min/1.73 m^2||Standard Deviation|Mean
2658000|NCT01601821|Secondary|Creatinine Clearance|Creatinine clearance (CCr) is a measure of kidney function. CCr is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 millimeters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.|Month 3, 6, 12|PP1 population. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is number of participants evaluable at specific time points for each arm group.|||mL/min||Standard Deviation|Mean
2658001|NCT01601821|Secondary|Serum Creatinine Level|Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 milligram per deciliter (mg/dL) for females and 0.6 to 1.2 mg/dL for males; however, the normal values are age-dependent as elderly patients typically have smaller muscle mass.|Month 3, 6, 12|PP1 population. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' is number of participants evaluable at specific time points for each arm group.|||mg/dL||Standard Deviation|Mean
2658002|NCT01601821|Primary|Incidence of Efficacy Failure|Efficacy failure was defined as first occurrence of either biopsy confirmed acute rejection, graft loss or death within 12 months of post-transplantation. Percentage of participants with efficacy failure was reported.|Baseline up to Month 12|Per-protocol 1 (PP1) population included all participants who had completed study, also included those who dropped out of study due to occurrence of death, graft loss, or biopsy-confirmed acute rejection and had no major protocol deviations.|||percentage of participants|||Number
2658003|NCT01601782|Primary|Accuracy of 3D Ultrasound Scanning Expressed as Percent Correlation Between Images From Conventional Ultrasound and Volume Imaging|Both ultrasound and volume imaging scans were done on the same day. For all scanned patients, the ultrasound technologist took a volume of images focusing where the patient had symptoms. The study PI reviewed the images, then went back in to do second scan. It took 5 to 10 minutes to complete a conventional ultrasound scan and up to 3 minutes to complete a volume imaging ultrasound scan.|Up to 13 minutes||||percent correlation|||Number
2658004|NCT01601704|Secondary|Percentage of Participants With a Confirmed Occurrence of Stroke (Nonfatal or Fatal)|Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.|Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up|Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.|||Participants|||Count of Participants
2658005|NCT01601704|Secondary|Percentage of Participants With a Confirmed Occurrence of Myocardial Infarction (Nonfatal or Fatal)|Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.|Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up|Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.|||Participants|||Count of Participants
2658006|NCT01601704|Secondary|Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death (Including Fatal Myocardial Infarction, Fatal Stroke)|Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.|Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up|Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.|||Participants|||Count of Participants
2658007|NCT01601704|Secondary|Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death, Nonfatal Myocardial Infarction, Nonfatal Stroke, or Nonfatal Unstable Angina Requiring Hospitalization|Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.|Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up|Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.|||Participants|||Count of Participants
2658008|NCT01601704|Primary|Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE)|The primary endpoint is the time from randomization to the first confirmed occurrence of any event within the primary MACE composite (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke). Due to early termination of the study, pre-planned 50% interim analysis is considered the primary analysis for outcome measures. The pre-planned 50% interim analysis was conducted when 50% of the total planned MACE were observed.|Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up|Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints.|||Participants|||Count of Participants
2658009|NCT01601691|Secondary|Rectum Radiation Dose|Rectum dose will be calculated based on CT scans after brachytherapy.|1 day, 4 weeks, 8 weeks|||||||
2658010|NCT01601691|Secondary|Side Effects|Possible side effects will be collected by subject interview and physical examination on specified time frame.|1 day, 4 weeks, 8 weeks, 12 weeks|||||||
2658011|NCT01601691|Primary|Spacer Volume Half Life|Time to spacer resolution will be measured based on the distance between rectum wall and prostate on CT scans before operation and on defined time frame. In addition, magnetic resonance imaging of pelvis will be performed 8 to 16 weeks after the operation in order to confirm the extent of spacer. Spacer volume half life is reported.|1 day, 4 weeks, 8 weeks, up-to 16 weeks||||days||Standard Deviation|Mean
2658012|NCT01601626|Other Pre-specified|RAL AUC in Participants Enrolled in Arm C|Describe RAL plasma PK characteristics (area under the curve [AUC] between 0 and 24 hours) in participants enrolled in Arm C, determined by non-compartmental analysis of 24-hour PK sampling. The pre-dose concentration was determined using a sample drawn 12 hours after the previous RAL dose and was used as the 12-hour RAL concentration.|At 2 weeks: pre-dose and at 2, 4, 5, 6, and 24 hours post-dose|Participants were included in this analysis if they completed the PK visit, did not miss any doses of any study-required medications on the day prior to the PK visit, and the RAL concentration at the pre-dose draw was above the assay's lower limit of quantification (5 ng/mL).|||hours*ng/mL||Inter-Quartile Range|Median
2658013|NCT01601626|Other Pre-specified|RAL Cmax and Cmin in Participants Enrolled in Arm C|Describe RAL plasma PK characteristics (Cmax and Cmin) in participants enrolled in Arm C, determined by non-compartmental analysis of 24-hour PK sampling. The pre-dose concentration was determined using a sample drawn 12 hours after the previous RAL dose and was used as the 12-hour RAL concentration.|At 2 weeks: pre-dose and at 2, 4, 5, 6, and 24 hours post-dose|Participants were included in this analysis if they completed the PK visit, did not miss any doses of any study-required medications on the day prior to the PK visit, and the RAL concentration at the pre-dose draw was above the assay's lower limit of quantification (5 ng/mL).|||ng/mL||Inter-Quartile Range|Median
2658014|NCT01601626|Other Pre-specified|RBT AUC in Participants Enrolled in Arms A and C|Describe RBT plasma PK characteristics (area under the curve [AUC] between 0 and 24 hours) in participants enrolled in Arms A and C, determined by non-compartmental analysis of 24-hour PK sampling. The pre-dose concentration was determined using a sample drawn 24 hours after the previous RBT dose. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|At 2 weeks: pre-dose and at 2, 4, 5, 6, and 24 hours post-dose|Participants were included in this analysis if they completed the PK visit, did not miss any doses of any study-required medications on the day prior to the PK visit, followed the protocol-required RBT dosing schedule, and the RBT concentration at the pre-dose draw was above the assay's lower limit of quantification (75 ng/mL).|||hours*ng/mL||Inter-Quartile Range|Median
2658015|NCT01601626|Other Pre-specified|RBT Cmax and Cmin in Participants Enrolled in Arms A and C|Describe RBT plasma PK characteristics (Cmax and Cmin) in participants enrolled in Arms A and C, determined by non-compartmental analysis of 24-hour PK sampling. The pre-dose concentration was determined using a sample drawn 24 hours after the previous RBT dose. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|At 2 weeks: pre-dose and at 2, 4, 5, 6, and 24 hours post-dose|Participants were included in this analysis if they completed the PK visit, did not miss any doses of any study-required medications on the day prior to the PK visit, followed the protocol-required RBT dosing schedule, and the RBT concentration at the pre-dose draw was above the assay's lower limit of quantification (75 ng/mL).|||ng/mL||Inter-Quartile Range|Median
2658070|NCT01601236|Secondary|Percent Change in eGFR at Visit 17|Percent change in eGFR at Visit 17 (Week 52) compared to baseline eGFR obtained during screening|Visit 17 (Week 52)|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||percent change||Standard Error|Least Squares Mean
2658016|NCT01601626|Other Pre-specified|LPV AUC in Participants Enrolled in Arms A, B, and C|Describe LPV plasma PK characteristics (area under the curve [AUC] between 0 and 12 hours) in participants enrolled in Arms A, B, and C, determined by non-compartmental analysis of 12-hour PK sampling. The pre-dose concentration was determined using a sample drawn 12 hours after the previous LPV dose and was used as the 12-hour LPV concentration. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|At 2 weeks: pre-dose and at 2, 4, 5, and 6 hours post-dose|Participants were included in this analysis if they completed the PK visit, did not miss any doses of any study-required medications on the day prior to the PK visit, and the LPV concentration at the pre-dose draw was above the assay's lower limit of quantification (20 ng/mL).|||hours*ng/mL||Inter-Quartile Range|Median
2658017|NCT01601626|Other Pre-specified|LPV Cmax and Cmin in Participants Enrolled in Arms A, B, and C|Describe LPV plasma pharmacokinetic (PK) characteristics (maximum concentration [Cmax] and minimum concentration [Cmin]) in participants enrolled in Arms A, B, and C, determined by non-compartmental analysis of 12-hour PK sampling. The pre-dose concentration was determined using a sample drawn 12 hours after the previous LPV dose and was used as the 12-hour LPV concentration. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|At 2 weeks: pre-dose and at 2, 4, 5, and 6 hours post-dose|Participants were included in this analysis if they completed the PK visit, did not miss any doses of any study-required medications on the day prior to the PK visit, and the LPV concentration at the pre-dose draw was above the assay's lower limit of quantification (20 ng/mL).|||ng/mL||Inter-Quartile Range|Median
2658018|NCT01601626|Secondary|Percent of Participants Who Experienced a New AIDS-defining Illness or Died|New post-randomization diagnoses were considered AIDS-defining based on the CDC classification system. The percent of participants who experienced a new AIDS-defining illness or died was calculated with an associated standard error. Confidence intervals were calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|After randomization and through week 72|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
2658019|NCT01601626|Secondary|Percent of Participants Who Died|The percent of participants who died was calculated with an associated standard error. Confidence intervals were calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|After randomization and through week 72|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
2658020|NCT01601626|Secondary|Percent of Participants Who Experienced a New AIDS-defining Illness|New post-randomization diagnoses were considered AIDS-defining based on the CDC classification system. The percent of participants who experienced a new AIDS-defining illness was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|After randomization and through week 72|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
2658021|NCT01601626|Secondary|CD4 Count Change From Baseline to Week 72|The difference in CD4 count from baseline to week 72 was calculated as the CD4 count at week 72 minus the CD4 count at baseline. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|Baseline and 72 weeks|Participants who had CD4 cell count data available at baseline and week 72 were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
2658022|NCT01601626|Secondary|CD4 Count Change From Baseline to Week 48|The difference in CD4 count from baseline to week 48 was calculated as the CD4 count at week 48 minus the CD4 count at baseline. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|Baseline and 48 weeks|Participants who had CD4 cell count data available at baseline and week 48 were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
2658023|NCT01601626|Secondary|CD4 Count Change From Baseline to Week 24|The difference in CD4 count from baseline to week 24 was calculated as the CD4 count at week 24 minus the CD4 count at baseline. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|Baseline and 24 weeks|Participants who had CD4 cell count data available at baseline and week 24 were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
2658024|NCT01601626|Secondary|CD4 Count Change From Baseline to Week 8|The difference in CD4 count from baseline to week 8 was calculated as the CD4 count at week 8 minus the CD4 count at baseline. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|Baseline and 8 weeks|Participants who had CD4 cell count data available at baseline and week 8 were included in the analysis.|||cells/mm^3||Inter-Quartile Range|Median
2658025|NCT01601626|Secondary|Number of Participants Who Experienced MTB IRIS|The number of participants who experienced MTB immune reconstitution inflammatory syndrome (IRIS) was summarized. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|After randomization and through week 72|All randomized participants were included.|||Participants|||Count of Participants
2658026|NCT01601626|Secondary|Cumulative Probability of HIV Virologic Failure at Week 72|Virologic failure was defined as the occurrence of two consecutive plasma HIV-1 RNA levels ≥1000 copies/mL at or after 16 weeks and within 24 weeks of treatment initiation or ≥400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized ART was being taken at the time of virologic failure. The percent of participants with HIV virologic failure at week 72 was calculated using a Kaplan-Meier estimator with an associated standard error. The confidence interval was calculated using a log-log transformation. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|At weeks 16, 24, 48, and 72|All randomized participants were included.|||cumulative events per 100 participants||95% Confidence Interval|Number
2658888|NCT01593787|Secondary|Percentage of Participants Achieving SBP Control at Week 8|SBP control was defined as msSBP <130 mmHg.|8 weeks|FAS|||Percentage of participants|||Number
2658027|NCT01601626|Secondary|Percent of Participants Who Experienced HIV Virologic Failure|Virologic failure was defined as the occurrence of two consecutive plasma HIV-1 RNA levels ≥1000 copies/mL at or after 16 weeks and within 24 weeks of treatment initiation or ≥400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized ART was being taken at the time of virologic failure. Participants who were missing data due to being lost-to-follow-up or dead were coded as virologic failures. The percent of participants who experienced HIV virologic failure was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|At weeks 16, 24, 48, and 72|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
2658028|NCT01601626|Secondary|Percent of Participants Who Interrupted or Discontinued at Least One TB Drug Due to Toxicity|The percent of participants who interrupted or discontinued at least one TB drug due to toxicity was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|After randomization and through to the discontinuation of the last TB drug|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
2658029|NCT01601626|Secondary|Percent of Participants Who Interrupted or Discontinued at Least One HIV Drug Due to Toxicity|The percent of participants who interrupted or discontinued at least one HIV drug due to toxicity was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|After randomization and through week 72|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
2658030|NCT01601626|Secondary|Number of Participants Reporting a Grade 3 or 4 Laboratory Abnormality|The number of participants reporting a grade 3 (severe) or grade 4 (life-threatening) laboratory abnormality were summarized. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|After randomization and through week 72|All randomized participants were included.|||Participants|||Count of Participants
2658031|NCT01601626|Secondary|Number of Participants Reporting a Grade 3 or 4 Sign or Symptom|The number of participants reporting a grade 3 (severe) or grade 4 (life-threatening) sign or symptom were summarized. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|After randomization and through week 72|All randomized participants were included.|||Participants|||Count of Participants
2658032|NCT01601626|Secondary|Percent of Participants Whose HIV Viral Load Was Less Than 50 Copies/mL at Week 48|The percent of participants whose HIV viral load was less than 50 copies/mL at week 48 was calculated with an associated standard error. Participants who were lost-to-follow-up or dead by week 48 or had missing RNA at week 48 were coded as having HIV viral load greater than 50 copies/mL. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|48 weeks|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
2658033|NCT01601626|Secondary|Percent of Participants Who Experienced TB Relapse/Recurrence and Who Had TB Drug Resistance|TB relapse/recurrence was defined as having had 2 consecutive MTB-negative cultures and subsequently had clinical or radiographic deterioration consistent with active TB at or after week 24 and before week 72. The drug resistance was determined based on phenotypic methods. The percent of participants who experienced TB relapse/recurrence and who had TB drug resistance was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|At or after 24 weeks and through week 72|All participants who experienced TB relapse/recurrence were included.|||participants||95% Confidence Interval|Number
2658034|NCT01601626|Secondary|Percent of Participants Who Experienced TB Relapse/Recurrence|TB relapse/recurrence was defined as having had 2 consecutive MTB-negative cultures and subsequently had clinical or radiographic deterioration consistent with active TB at or after week 24 and before week 72. The percent of participants who experienced TB relapse/recurrence was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|At or after 24 weeks and through week 72|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
2658035|NCT01601626|Secondary|Percent of Participants Who Experienced TB Treatment Failure|TB treatment failure was defined as having a MTB-positive culture after 16 weeks of TB treatment for a participant who was documented to be taking TB medications. The percent of participants who experienced TB treatment failure was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|After 16 weeks and through week 72|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
2658036|NCT01601626|Secondary|Percent of Participants Who Experienced Sputum Conversion at Week 8.|Sputum conversion was defined as culture MTB-negative at week 8 or AFB smear negative at week 8 (and culture contaminated or missing at week 8); there were no Xpert MTB/RIF results at week 8. The percent of participants experienced sputum conversion at week 8 was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|8 weeks|Participants who were either culture MTB-positive at entry; AFB smear positive at entry (and culture MTB-negative, contaminated, or missing at entry); or Xpert MTB/RIF positive at entry (and culture or smear negative, contaminated, or missing at entry) were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2658889|NCT01593787|Secondary|Percentage of Participants Achieving a Successful BP Control at Week 8|A successful BP control was defined as msSBP <130 mmHg and msDBP <80 mmHg|8 weeks|FAS|||Percentage of Participants|||Number
2658037|NCT01601626|Primary|Percent of Participants Whose HIV Viral Load Was Less Than 400 Copies/mL at Week 48.|The percent of participants whose HIV viral load was less than 400 copies/mL at week 48 was calculated with an associated standard error. The confidence interval was calculated using Wilson's score method. Participants who were lost-to-follow-up or dead by week 48 or had missing results at week 48 were coded as having HIV viral load greater than 400 copies/mL. As stated in the Detailed Study Description of the Protocol Section, formal statistical comparisons were not undertaken because of limited sample size.|48 weeks|All randomized participants were included.|||percentage of participants||95% Confidence Interval|Number
2658038|NCT01601535|Secondary|One Year Progression Free Survival Rate|To determine the progression free survival rates for patients with relapsed or refractory neuroblastoma treated with MLN8237, irinotecan, and temozolomide at the identified MTD|1 Years after completion of study|The analysis was performed in phase II patients.|||Participants|||Count of Participants
2658039|NCT01601535|Secondary|AURKA Genotype|To explore whether AURKA genotype is associated with antitumor activity in children with refractory neuroblastoma treated with the combination of MLN8237, irinotecan, and temozolomide.|Day 7 of cycle 1|Consisting of patients treated on the Phase 1 (n = 22), Phase 2 (n = 20), and Oral Solution (n = 12) cohorts.|||participants|||Number
2658040|NCT01601535|Secondary|UGT1A1 Genotype|To explore whether UGT1A1 genotype is associated with toxicity in children with refractory neuroblastoma treated with the combination of MLN8237, irinotecan, and temozolomide|Day 7 of cycle 1|Consisting of patients treated on the Phase 1 (n = 22), Phase 2 (n = 20), and Oral Solution (n = 12) cohorts.|||participants|||Number
2658041|NCT01601535|Secondary|Aurora A Expression|To explore whether MYCN status and markers of expression of Aurora A in archival tumor tissue are associated with the antitumor activity of the combination of MLN8237, irinotecan, and temozolomide|From date of study enrollment to the date of progression or withdrawal from the study, up to 34 cycles (about 2 years).|Consisting of patients treated on the Phase 1 (n = 22), Phase 2 (n = 20), and Oral Solution (n = 12) cohorts.|||participants|||Number
2658042|NCT01601535|Primary|Response Rate for Patients With Relapsed or Refractory Neuroblastoma Treated With MLN8237, Irinotecan, and Temozolomide at the Identified MTD|Response was graded according to version 1.2 of the NANT response criteria that classifies patients as having one of the following overall response categories based upon underlying response at soft tissue sites, MIBG positive sites, and bone marrow disease: complete response (CR); CR with minimal residual disease (CR-MRD); partial response (PR); minor response (MR); stable disease (SD); and progressive disease (PD). These criteria utilize RECIST criteria for measurable tumors, Curie score for MIBG scan response, and bone marrow (BM) morphology. BM response was graded as CR (required two time points to confirm), CR unconfirmed (one time point only), CR-MRD (bone marrow involvement < 5% at study entry with negative follow-up biopsies), SD, or PD. Patients with at least SD or better underwent central review of MIBG scans, CT scans, and bone marrow pathology slides. Overall responses of CR, CR-MRD, or PR were considered objective responses.|Cycles repeated every 21 days for up to 34 cycles.|The analysis was performed on 19 phase II patients, with 1 inevaluable patient excluded.|||Participants|||Count of Participants
2658043|NCT01601535|Primary|Pharmacokinetics When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma: Irinotecan Clearance|Outcomes included Alisertib, irinotecan, APC, SN-38, and SN-38G. APC, SN-38, and SN-38G are metabolites of irinotecan.|1st week of cycle 1||||L/h||Full Range|Median
2658044|NCT01601535|Primary|Pharmacokinetics When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma: Irinotecan AUC, APC AUC, SN-38 AUC, and SN-38G AUC|Outcomes included Alisertib, irinotecan, APC, SN-38, and SN-38G. APC, SN-38, and SN-38G are metabolites of irinotecan.|1st week of cycle 1||||h·ng/mL||Full Range|Median
2658045|NCT01601535|Primary|Pharmacokinetics When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma: Irinotecan Cmax, APC Cmax, SN-38 Cmax, and SN-38G Cmax|Outcomes included Alisertib, irinotecan, APC, SN-38, and SN-38G. APC, SN-38, and SN-38G are metabolites of irinotecan.|1st week of cycle 1||||ng/mL||Full Range|Median
2658046|NCT01601535|Primary|Pharmacokinetics When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma: Alisertib AUC|Outcomes included Alisertib, irinotecan, APC, SN-38, and SN-38G. APC, SN-38, and SN-38G are metabolites of irinotecan.|1st week of cycle 1||||µM•hour||Full Range|Median
2658047|NCT01601535|Primary|Pharmacokinetics When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma: Alisertib Tmax and Half-life|Outcomes included Alisertib, irinotecan, APC, SN-38, and SN-38G. APC, SN-38, and SN-38G are metabolites of irinotecan.|1st week of cycle 1||||hour||Full Range|Median
2658048|NCT01601535|Primary|Pharmacokinetics When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma: Alisertib Day 4 Trough, Day 5 Trough and Cmax|Outcomes included Alisertib, irinotecan, APC, SN-38, and SN-38G. APC, SN-38, and SN-38G are metabolites of irinotecan.|1st week of cycle 1||||µM||Full Range|Median
2658049|NCT01601535|Primary|Dose Limiting Toxicity (DLT) Data Associated With the Determination of the Recommended Phase 2 Dose|The MTD was the highest dose level tested at which fewer than two of six patients had first course DLT. Hematologic DLT was defined as grade 4 neutropenia for more than 7 days, need for platelet transfusion for a platelet count of less than 20,000/mL twice within a 7-day period, or greater than 14-day delay in the start of a subsequent course because of neutropenia or thrombocytopenia. Nonhematologic DLT was defined as any nonhematologic toxicity that delayed the start of a subsequent cycle by more than 14 days or any grade ≥3 toxicity with the exception of the following grade 3 toxicities: nausea, vomiting, anorexia, or dehydration resolving to grade ≤ 2 within 72 hours; increase in hepatic transaminase or electrolyte abnormality resolving to grade ≤ 1 within 7 days; diarrhea persisting for less than 72 hours; fever; infection; or febrile neutropenia. DLT definitions included only toxicities deemed at least possibly related to therapy.|21 days, from study day 1||||DLTs|||Number
2658086|NCT01600885|Primary|Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Superior Frontal Gyrus|Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)|Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion|ALL SUBJECTS WHO COMPLETED THE STUDY WERE INCLUDED IN ANALYSIS|||percent change in saline signal||Standard Error|Mean
2658050|NCT01601535|Primary|Maximum Tolerated Dose (MTD) When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma|The MTD was the highest dose level tested at which fewer than two of six patients had first course DLT. Hematologic DLT was defined as grade 4 neutropenia for more than 7 days, need for platelet transfusion for a platelet count of less than 20,000/mL twice within a 7-day period, or greater than 14-day delay in the start of a subsequent course because of neutropenia or thrombocytopenia. Nonhematologic DLT was defined as any nonhematologic toxicity that delayed the start of a subsequent cycle by more than 14 days or any grade ≥3 toxicity with the exception of the following grade 3 toxicities: nausea, vomiting, anorexia, or dehydration resolving to grade ≤ 2 within 72 hours; increase in hepatic transaminase or electrolyte abnormality resolving to grade ≤ 1 within 7 days; diarrhea persisting for less than 72 hours; fever; infection; or febrile neutropenia. DLT definitions included only toxicities deemed at least possibly related to therapy.|21 days, from study day 1||||mg/m^2|||Number
2658051|NCT01601470|Secondary|Adverse Events, Serious Adverse Events and Deaths Were Monitored From Screening to End of Study|Number of patients with adverse events, serious adverse events and death|From the screening visit until 30 days past the final study assessment|Safety Analysis Set: This set included participants who received at least one dose of study drug.|||Participants|||Number
2658052|NCT01601470|Primary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil will be assessed. 8pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. All time-points were used to mathematically derive the single PK parameter.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.|||hours||Full Range|Median
2658053|NCT01601470|Primary|Maximum Plasma Concentration Following Drug Administration (Cmax) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. All time-points were used to mathematically derive the single PK parameter.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.|||ng/mL||Standard Deviation|Mean
2658054|NCT01601470|Primary|Terminal Elimination Half-life (T1/2) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. T1/2 is a mathematically-derived value from all measurements. T1/2 is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.|||hours||Standard Deviation|Mean
2658055|NCT01601470|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. AUC is a mathematically-derived value from all measurements. AUC is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.|||h*ng/mL||Standard Deviation|Mean
2658056|NCT01601470|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Sildenafil and N-desmethyl-sildenafil Analytes|The effect of co-administration of LCZ696 on the pharmacokinetics of Sildenafil and N-desmethyl-sildenafil was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. AUC is a mathematically-derived value from all measurements. AUC is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.|||h*ng/mL||Standard Deviation|Mean
2658057|NCT01601470|Primary|Time to Reach the Maximum Concentration After Drug Administration (Tmax) of LCZ696 Analytes (AHU377, LBQ657 and Valsartan)|The effect of co-administration of sildenafil on the pharmacokinetics of LCZ696 (analytes of LCZ696: AHU377, LBQ657 and valsartan) was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. Tmax is a mathematically-derived value from all measurements. Tmax is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.|||hours||Full Range|Median
2658071|NCT01601236|Primary|Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12|Percent change in eGFR at Visit 12 (Week 36) compared to average baseline eGFR obtained during screening|Visit 12 (Week 36)|This trial had an adaptive design that pre-specified the closure of the 32 U (units) (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||percent change||Standard Error|Least Squares Mean
2658099|NCT01600677|Secondary|Medication-reconciliation Errors During Transition From Hospital to Home|Using the previously validated and reliable medication discrepancy tool (MDT)|90-day||||Participants with errors|||Number
2658058|NCT01601470|Primary|Minimum Plasma Concentration Following Drug Administration at Steady State (Cmin,ss) of LCZ696 Analytes (AHU377, LBQ696 and Valsartan)|The effect of co-administration of sildenafil on the pharmacokinetics of LCZ696 (analytes of LCZ696: AHU377, LBQ657 and valsartan) was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. Cmin is a mathematically-derived value from all measurements. Cmin is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.|||ng/mL||Standard Deviation|Mean
2658059|NCT01601470|Primary|Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of LCZ696 Analytes (AHU377, LBQ657 and Valsartan)|The effect of co-administration of sildenafil on the pharmacokinetics of LCZ696 (analytes of LCZ696: AHU377, LBQ657 and valsartan) was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, and day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. Cmax is a mathematically-derived value from all measurements. Cmax is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.|||ng/mL||Standard Deviation|Mean
2658060|NCT01601470|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval (AUCtau) of LCZ696 Analytes|The effect of co-administration of sildenafil on the pharmacokinetics of LCZ696 (analytes of LCZ696: AHU377, LBQ657 and valsartan) was assessed. Blood samples were collected at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose from day 1 to day 7, 24 hours post-dose from day 7, and day 8 at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose. AUC is a mathematically-derived value from all measurements. AUC is a measure of the area under the curve that is obtained from plotting the plasma concentration by time point. All time-points were used to derive the single PK parameters.|From pre-dose on day 1 until 12 hours post dose on day 8|PK Analysis Set (Period 3): This set included participants with evaluable PK data and without any protocol deviations which could impact the PK data.|||h*ng/mL||Standard Deviation|Mean
2658061|NCT01601431|Primary|ADR Differences in Hispanic Patients Undergoing a Screening Colonoscopy With and Without Cap.|1. Compare ADR between Hispanic patients undergoing a screening colonoscopy with and without cap.|1 year||||Participants|||Count of Participants
2658062|NCT01601236|Other Pre-specified|Change in Mean HbA1c|Change from baseline mean HbA1c (%) to Week 36|Week 36|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||%HbA1c||Standard Deviation|Mean
2658063|NCT01601236|Secondary|Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol|Percent change from baseline of serum total cholesterol, triglycerides, LDL, HDL, Lp(a), albumin, and cortisol|Visit 6, 9, 12, and 17|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||percent change||Standard Deviation|Mean
2658064|NCT01601236|Secondary|Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria|Proportion of subjects whose best response was complete remission (PCR 0.5 g/g) or partial remission (reduction in PCR of >50% from baseline, plus PCR≤2.5 g/g but >0.5 g/g) of proteinuria|Visit 12 (Week 36) and Visit 17 (Week 52)|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||Participants|||Count of Participants
2658065|NCT01601236|Secondary|Percent Change From Baseline in Protein to Creatinine Ratio (PCR)|Percent change from baseline in PCR|Visits 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||percent change||Standard Error|Mean
2658066|NCT01601236|Secondary|Percent Change From Baseline in eGFR by Visit|Percent change from baseline in eGFR by visit|Visit 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||percent change||Standard Deviation|Mean
2658067|NCT01601236|Secondary|Percent Change in eGFR Calculated Using Cystatin C|Percent change in eGFR calculated using cystatin C compared to baseline obtained at Visit 2.|Visit 12 (Week 36) and Visit 17 (Week 52)|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||percent change||Standard Deviation|Mean
2658068|NCT01601236|Secondary|Complete or Partial Remission of Proteinuria|Proportion of patients with complete remission (PCR 0.5 g/g) or partial remission (reduction in PCR of >50% from baseline, plus PCR≤2.5 g/g but >0.5 g/g) of proteinuria at Visit 12 (Week 36) and/or at Visit 17 (Week 52)|Visit 12 (Week 36) and Visit 17 (Week 52)|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||Participants|||Count of Participants
2658069|NCT01601236|Secondary|Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death||Visit 12 (Week 36) and Visit 17 (Week 52)|This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).|||Participants|||Count of Participants
2658074|NCT01601132|Primary|Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0-∞)] was calculated as the sum of AUC (0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for theophylline.|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|PK population|||hours*μg/mL||Standard Deviation|Mean
2658075|NCT01601132|Primary|Area Under the Concentration Versus Time Curve From Time 0 to Time of the Last Quantifiable Concentration[AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for theophylline.|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|PK population|||hours*μg/mL||Standard Deviation|Mean
2658076|NCT01601132|Primary|Maximum Plasma Concentration (Cmax) of Theophylline|The maximum or peak concentration of theophylline in the plasma, after a single dose on Day 1, and after another single dose on Day 19 following 14 days of colchicine dosing.|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|The pharmacokinetic (PK) population is defined as any participant who took a single dose of study medication and had sufficient blood sampling to characterize the non-compartmental PK parameters.|||μg/mL||Standard Deviation|Mean
2658077|NCT01601132|Primary|Time to Reach the Maximum Plasma Concentration (Tmax) of Theophylline|The time to each the maximum or peak concentration of theophylline in the plasma, after a single dose on Day 1, and after a single dose on Day 19, following 14 days of colchicine dosing.|Day 1 and Day 19 blood samples drawn pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours after dose administration.|The pharmacokinetic (PK) population is defined as any participant who took a single dose of study medication and had sufficient blood sampling to characterize the non-compartmental PK parameters. Patients with available data are included in the analysis.|||hours||Full Range|Median
2658078|NCT01601067|Secondary|Timeline Follow-Back Procedure (TLFB) for Alcohol Use|Frequency and quantity of alcohol use were assessed using the Timeline Follow-Back, a calendar-assisted structured clinical interview that displays good psychometric properties. The PHDD was calculated by dividing the number of days in which 5 or more drinks for men or 4 or more drinks for women were consumed by the total number of days in the reference period.|baseline to 6-month follow-up||||percentage of days||95% Confidence Interval|Mean
2658079|NCT01601067|Primary|Clinician Administered PTSD Scale (CAPS)|The CAPS-5 (score range, 0-80, with 0 indicating no PTSD symptoms and 80 indicating extreme ratings across all symptoms), a 30-item structured interview considered to be the criterion standard for PTSD, was the primary measure of PTSD symptoms and diagnosis. Diagnosis was determined using the rule of a severity score of 2 or higher, which follows DSM-5 PTSD criteria.|baseline through 6 month follow-up||||score on a scale||95% Confidence Interval|Mean
2658080|NCT01600950|Secondary|Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2963016 and Lantus|AUC was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.|Periods 1 and 2: Baseline up to 42 hours postdose|No participants were analyzed because of insufficient data.||||||
2658081|NCT01600950|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2963016 and Lantus|Cmax was not analyzed because of insufficient data due to concentrations being below the quantifiable lower limit of the assay.|Periods 1 and 2: Baseline up to 42 hours postdose|No participants were analyzed because of insufficient data.||||||
2658082|NCT01600950|Secondary|Time of Maximum Glucose Infusion Rate (tRmax)|tRmax is the time to reach maximum glucose infusion rate and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate.|Periods 1 and 2: Baseline up to 42 hours postdose|All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received.|||hours (hr)||Full Range|Median
2658083|NCT01600950|Secondary|Total Glucose Infused (Gtot)|Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the total glucose infused, adjusted by body weight.|Periods 1 and 2: Baseline up to 42 hours postdose|All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received.|||milligrams/kilogram (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
2658084|NCT01600950|Secondary|Maximum Glucose Infusion Rate (Rmax)|Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain a target blood glucose level of 100 milligrams/deciliter (mg/dL) [5.6 millimoles/Liter (mmol/L)] and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of study drug by adjusting the exogenous glucose infusion rate. Data presented are the maximum infusion rates, adjusted by body weight.|Periods 1 and 2: Baseline up to 42 hours postdose|All randomized participants who received the study drug during Periods 1 or 2. Participants were analyzed based on the treatment they received.|||milligrams/kilogram/minute (mg/kg/min)||Geometric Coefficient of Variation|Geometric Mean
2658085|NCT01600950|Primary|Pharmacodynamics: Duration of Action of LY2963016 and Lantus|Duration of action is defined as the period of time elapsed between dose administration and the time at which the participant's blood glucose is consistently >150 milligrams/deciliter (mg/dL) without any glucose infusion. Participants whose blood glucose did not rise to 150 mg/dL were censored 42 hours postdose.|Periods 1 and 2: Baseline up to 42 hours postdose|All randomized participants who received study drug during Periods 1 or 2. Participants were analyzed based on treatment they received. The numbers of participants censored were 7 for both LY2963016 and Lantus groups. Maximum duration of actions is based on participants who reached the end of action before 42 hours: 13 participants for both groups.|||hours (hr)||Full Range|Median
2658100|NCT01600677|Primary|Medication Adherence|Will be measured by: (number of doses/ doses scheduled; EMMA (intervention) vs. determined by manual monthly pill counts (control))|90-day||||percentage of medication adherence||Standard Deviation|Mean
2658087|NCT01600885|Primary|Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Middle Frontal Gyrus|Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)|Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion|ALL SUBJECTS WHO COMPLETED THE STUDY WERE INCLUDED IN ANALYSIS|||percent change in saline signal||Standard Error|Mean
2658088|NCT01600885|Primary|Percent Change in Amelioration of Ketamine-related Task Activation as Measured by Functional Magnetic Resonance Imaging in Inferior Parietal Lobule|"Scans will be analyzed for task-related prefrontal activation~Difference Score: Percent Signal Change in Regions of Interest (ketamine - saline)"|Within 4 hours of dose administration, after up to 1.25 hours of ketamine infusion|ALL SUBJECTS WHO COMPLETED THE STUDY WERE INCLUDED IN ANALYSIS|||percent change in saline signal||Standard Error|Mean
2658089|NCT01600729|Primary|Intra-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)|Intra-rater (within raters) agreement of the FWS-A scores (0=none; 1=mild; 2=moderate; 3=severe) was evaluated by weighted Kappa statistics (WKS). WKS were calculated for each of 7 raters who evaluated 65 participant's severity of facial lines in 4 areas (Glabellar Lines, Forehead Lines, Crow's Feet Lines on the Left side of the face and Crow's Feet Lines on the Right side of the face) at rest and maximum expression using the FWS-A scale at 2 different time-points on Day 1. The overall intra-rater agreement for WKS for all raters combined was estimated by pooling WKS for each rater using a chi-square statistic. The degree of agreement of the point estimates of WKS was interpreted according to the reference range scale that was predefined as: ≤0=poor, 0.00-0.20=slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial and 0.81-1.00=almost perfect. The 95% confidence interval for WKS was provided.|Day 1|Participants from the Reliability population (all enrolled participants with at least 1 assessment by at least 1 live rater performed on day 1) who had 2 assessments on Day 1 available for analysis.|||Kappa statistics||95% Confidence Interval|Mean
2658090|NCT01600729|Primary|Inter-rater Reliability of Assessment of Facial Lines Using the 4-Point Facial Wrinkle Scale (FWS-A)|Inter-rater (among raters) agreement of the FWS-A scores (0= none; 1= mild; 2= moderate; 3= severe) was evaluated by Kappa statistics. Kappa statistics were calculated for each of 7 raters who evaluated 66 participant's severity of facial lines in 4 areas (Glabellar Lines, Forehead Lines, Crow's Feet Lines on the Left side of the face and Crow's Feet Lines on the Right side of the face) at rest and maximum expression using the FWS-A scale. The overall inter-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was predefined as: ≤ 0= poor, 0.00-0.20= slight, 0.21-0.40= fair, 0.41-0.60= moderate, 0.61-0.80= substantial and 0.81-1.00= almost perfect. The 95% confidence interval for Kappa statistics was provided.|Day 1|Reliability population included all enrolled participants with at least 1 assessment by at least 1 live rater performed on day 1.|||Kappa statistics||95% Confidence Interval|Mean
2658091|NCT01600716|Other Pre-specified|Duration of Treatment Effect Through Week 52|The duration of treatment effect is the time to patient request for retreatment.|Up to 52 Weeks|Intent-to-Treat Population: all randomized patients|||Weeks||95% Confidence Interval|Median
2658092|NCT01600716|Secondary|Change From Baseline in Incontinence Quality of Life Instrument (I-QOL) Total Summary Score|The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement and a negative change from baseline represents a worsening.|Baseline, Week 6|Intent-to-Treat Population: all randomized patients with data at the time points|||Scores on a Scale||Standard Deviation|Mean
2658093|NCT01600716|Secondary|Change From Baseline in Maximum Detrusor Pressure During the First Involuntary Detrusor Contraction (IDC)|Maximum detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. A negative number change from baseline indicates an improvement in pressure and a positive number change from baseline indicates a worsening in pressure.|Baseline, Week 6|Intent-to-Treat Population: all randomized patients with data at the time points|||Centimeters of Water (cm H2O)||Standard Deviation|Mean
2658094|NCT01600716|Secondary|Change From Baseline in Maximum Cystometric Capacity (MCC)|MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in the maximum volume of urine the bladder holds and a negative number change from baseline represents a worsening (decrease) in the maximum volume of urine the bladder holds.|Baseline, Week 6|Intent-to-Treat Population: all randomized patients with data at the time points|||Milliliters (mL)||Standard Deviation|Mean
2658095|NCT01600716|Primary|Change From Baseline in Daily Average Frequency of Urinary Incontinence Episodes|Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. The number of episodes of urinary incontinence is recorded over a 3-day period the week of the study visit. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change indicates an increase in incontinence episodes (worsening).|Baseline, Week 6|Intent-to-Treat Population: all randomized patients|||Episodes||Standard Deviation|Mean
2658096|NCT01600703|Secondary|Apolipoprotein B100 Production Rate After Acute Oral Administration of 100mg Sitagliptin (Compared to Placebo)|Apolipoprotein B100 turnover was measured in a 10-hour kinetic study with in vivo tracer techniques and mathematical modeling to calculate production rates. Studies were performed under conditions of a pancreatic clamp and a steady state fed state in volunteers receiving single oral dose of either 100mg sitagliptin or matching placebo.|10 hours||||mg/kg/day||Standard Error|Mean
2658097|NCT01600703|Primary|Apolipoprotein B48 Production Rate After Acute Oral Administration of 100mg Sitagliptin (Compared to Placebo)|Apolipoprotein B48 turnover was measured in a 10-hour kinetic study with in vivo tracer techniques and mathematical modeling to calculate production rates. Studies were performed under conditions of a pancreatic clamp and a steady state fed state in volunteers receiving single oral dose of either 100mg sitagliptin or matching placebo.|10 hours||||ug/kg/day||Standard Error|Mean
2658098|NCT01600677|Secondary|Hospital Readmission Rates|Determine the percentage of patients that are readmitted to the hospital within 30 days of discharge|30 day||||% readmissions|||Number
2658101|NCT01600586|Secondary|Number of Days to Full Oral Feeds|Aim: Quantify the effect of the PAL intervention on efficiency of sucking and time to reaching full oral feeds in comparison to controls. Data on the number of days from Day 0 of the study to the date of first documented full oral feed, up to 70 days (or date of death from any cause) were be recorded from the chart.|Day 0 of the study to the date of first documented full oral feed (up to 70 days)||||days||Inter-Quartile Range|Median
2658102|NCT01600586|Secondary|Hospital Length of Stay|Description: Data on hospital stay was recorded from the chart. The participants were be followed for the duration of the hospital stay from the time of consent for participation to the time discharge from the NICU is documented.|days from consent to discharge||||days||Inter-Quartile Range|Median
2658103|NCT01600586|Secondary|Change From Pre-test(Day 0)in Salivary Cortisol Levels to Post-test (Day 5)|Description: Stress: Salivary cortisol levels at baseline and after 1 week of PAL in the intervention group.|Day 0, and Day 5|Specific data is no longer available, Outcome is described here: http://pediatrics.aappublications.org/content/133/3/462.full||||||
2658104|NCT01600586|Secondary|Discharge Weight|Description: Growth measures.|day of hospital discharge (approximately 5-7 weeks)||||grams||Inter-Quartile Range|Median
2658105|NCT01600586|Primary|Suck Rate and Efficiency: Change From Pre-test (Day 0) to Post-test (Day 5)|Feeding rate when nippling was calculated by dividing the number of cc of nippled nutrition by time for consumption. This data was recorded at two time points: pre and post intervention|Day 0, and Day 5||||mL/min||Inter-Quartile Range|Mean
2658106|NCT01600495|Secondary|Number of Participants Who Were Satisfied With the Presence of a Professional/Physiotherapist During Labor.|Simple questionnaire (Questionnaire satisfaction of parturients with comparision with experience in this study) developed for this study with 3 items (yes, no and do not want to answer) to assess satisfaction of mothers in the intervention group and the control group regarding the presence of a professional during the period of study and experience in this work.|10 hours|All patients were invited to answer the questionnaire.|||participants|||Number
2658107|NCT01600495|Secondary|Duration From Start of Labor Until Birth|The length of time of labor, specified number of minutes since the opening of the partograph (early labor) until the birth of the child.|10 hours|Analyzing the duration of labor|||min||Standard Deviation|Mean
2658108|NCT01600495|Secondary|Evaluation of TENS During the Active Phase of Labor Over the Use of Analgesia|Consider whether the TENS therapy during the active phase of labor could defer request for analgesia use for pain relief for pregnant women. The cervical dilation indicates the value in centimeters (0-10) of cervical dilation. Assessed on admission and during labor by doctors (according to the routine of the institution), as recorded in medical records.|10 hours|Analyzing the date of application of pharmacological analgesia.|||cm||Standard Deviation|Mean
2658109|NCT01600495|Primary|Classification of Pain During Labor by Visual Analogue Scale|"To evaluate the Transcutaneous Electrical Nerve Stimulation as a resource for pain relief during the active phase of labor will be used the Visual Analogue Scale.~Visual analogue scale (VAS): this scale, represented by a rule, the patient estimated pain on a scale of 100 mm (at one end labeled no pain associated with a score of 0 mm and at the other end worst pain imagined with a score 100 mm)"|30 minutes|We evaluated 46 patients, divided into 23 ENT group and 23 in the control group.|||mm||Standard Deviation|Mean
2658110|NCT01600482|Secondary|Device Success|Device Success (DS) is defined as the successful deployment of the Celt ACD device with the attainment of haemostasis and only assessed in the Celt ACD arm of the study.|30 days +/- 7 days|7 patients in the MP group did not have TTH recorded.|||Number of patients|||Number
2658111|NCT01600482|Secondary|Procedure Success|Procedure Success 30 days +/- 7 days|30 days +/- 7 days|7 patients were excluded in Manual Compression group as there was no TTH data recorded.|||Number of patients|||Number
2658112|NCT01600482|Secondary|Time to Discharge-ability|Time to discharge-ability|30 days +/- 7 days|107 did not have time to dischargeability data collected.|||Minutes||Standard Deviation|Mean
2658113|NCT01600482|Secondary|Time to Ambulation|Time to Ambulation (TTA) is defined as the time elapsed between sheath removal and time when the patient stands and walk 6m (20ft) without re-bleeding.|With in the first 30 days +/- 7 days following the procedure|62 patients did not have TTA recorded.|||minutes||Standard Deviation|Mean
2658114|NCT01600482|Secondary|The Secondary Safety Endpoint Will be the Combined Rate of Minor Complications With in 30 +/- 7 Days Following Procedure.|combined rate of minor complications with in 30 +/- 7 days following procedure.|With in the first 30 days +/- 7 days following the procedure||||minor complications|||Number
2658115|NCT01600482|Primary|The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH)|Time to hemostasis|With in the first 30 days +/- 7 days following the procedure|7 subjects in manual compression group where TTH was not recorded.|||minutes||Standard Deviation|Mean
2658116|NCT01600482|Primary|The Primary Safety Endpoint Will be the Combined Rate of Major Complications With in 30 +/- 7 Days Following the Percutaneous Coronary Intervention (PCI) Procedure.|rate of major complications with in 30 +/- 7 days following the PCI procedure.|With in the first 30 days +/- 7 days following the procedure||||major complications|||Number
2658117|NCT01600326|Secondary|Number of Participants Showing Symptomatic Improvement as Assessed in Patient Chart|Information from patient charts were retrospectively reviewed to determine if symptoms were reported as improved, worse, or no change over a time period (range 15 to 555 days post treatment).|15 to 555 days post treatment||||Participants|||Count of Participants
2658118|NCT01600326|Primary|Pain Level and Interference With Activity|"Patient symptoms are measured on a 50 point scale where 0 is no pain or interference with activities and 50 is highest pain and interference.~A verbal evaluation and assessment of subject's pain and symptoms will be completed prior to treatment. After receiving medication a second evaluation will be taken to determine how well the medication has relieved and controlled the subject's pain and inflammation associated with tendinitis.~Subjects will be specifically asked to rate the level of pain and how the pain is affecting common activities of daily living. The outcomes will be assessed at 2 follow up periods, 1 and approximately 2 weeks after treatment (but no more than 23 days)."|Up to 23 days|One data point is missing for time point one for Plasma Injection Group, as noted below.|||units on a scale||Full Range|Mean
2658119|NCT01600287|Other Pre-specified|Number of Times Rate of Propofol Changed Manually|Number of times rate of propofol needed to be changed manually|8 hours(aprrox)||||times per hour||Full Range|Median
2658124|NCT01600287|Other Pre-specified|Minimum BIS During Induction|Bispectral Index(BIS) is an EEG-based objective measure of anesthetic depth with values ranging from 100 to 0, lower number indicating greater depth of anesthesia. Values between 40 to 60 indicate adequate depth required for surgery. During induction of anesthesia, there is a tendency of overshooting the adequate depth of anesthesia, due to use of higher dose and rate of administration required for induction. The minimum BIS achieved during induction is a measure of this overshoot. The less the minimum value, the more is the overshoot, worse the outcome is. The minimum BIS during induction is automatically stored in the PC used for the study.|15 minutes||||Bispectral Index||Standard Deviation|Mean
2658125|NCT01600287|Other Pre-specified|Induction Time|Time required for the first time achievement of two subsequent BIS values below or equal to 55|10 minutes||||seconds||Standard Deviation|Mean
2658126|NCT01600287|Other Pre-specified|Induction Dose of Propofol|Dose of propofol needed for induction|10 minutes||||mg per kg body weight||Standard Deviation|Mean
2658127|NCT01600287|Secondary|Intraoperative Phenylephrine Used (Pre CPB)|total phenylephrine dose needed to be used in the pre CPB period to maintain hemodynamic stability|2 hours(approx)||||microgram per Kg body weight||Standard Deviation|Mean
2658128|NCT01600287|Secondary|Global Score|overall performance assessment of the system calculated as= [(MDAPE+Wobble)/percentage of time BIS remains within target]x100 Lower score indicates better overall performance|8 hours (approx)||||percentage of time||Standard Deviation|Mean
2658129|NCT01600287|Secondary|Divergence|slope of the linear regression curve of performance error against time.|8 hours (approx)||||errors per second||Standard Deviation|Mean
2658130|NCT01600287|Secondary|Intra-operative Awareness|The number of patients who will be able to recall the intra-operative events when assessed postoperatively. This will be assessed by a structured protocol|Approximately 3 days and then 1 month later||||participants|||Number
2658131|NCT01600287|Secondary|Percentage of Time Mean Arterial Pressure Remains Within 25% of Pre-op Baseline|The duration of time mean arterial pressure remains within 25% of the pre-operative baseline value during the period propofol (general anesthetic) is administered to the study population. This value is expressed as percentage. This outcome is expressed as the mean of percentage of time per participant|Approximately 8 hours||||percentage of time||Standard Deviation|Mean
2658132|NCT01600287|Secondary|Percentage of Time Heart Rate Remains Within 25% of Pre-op Baseline|The duration of time heart rate remains within 25% of the pre-operative baseline value during the period propofol (general anesthetic) is administered to the study population. This value is expressed as a percentage. This outcome is expressed as the mean of percentage of time per participant.|Approximately 8 hours||||percentage of time||Standard Deviation|Mean
2658133|NCT01600287|Secondary|Wobble|Wobble measures the intra-individual variability in performance error.The median of the difference between individual performance errors throughout anesthesia and the median performance error for each participant is the wobble of that participant. The mean value per participant is indicated in the outcome measure.|Approximately 8 hours||||errors per participant||Standard Deviation|Mean
2658134|NCT01600287|Secondary|Median Absolute Performance Error(MDAPE)|The difference between the observed and target of measure of depth of anesthesia (BIS) expressed as percentage of target BIS is calculated as performance error every 30 seconds. This value may be either '+' or '_' indicating whether the observed measure is above the target (overshoot-+) or below the target (undershoot-_).The median of the absolute values of performance errors (without considering the direction of error) is median absolute performance error. This outcome measures the magnitude of error or inaccuracy of the system studied. A lower value indicates a more precise system.This outcome is expressed as the mean of Median Absolute Performance Errors per participant.|Approximately 8 hours||||errors per participant||Standard Deviation|Mean
2658135|NCT01600287|Secondary|Median Performance Error(MDPE)|The difference between the observed and target of measure of depth of anesthesia (BIS) expressed as percentage of target BIS is calculated as performance error every 30 seconds. This value may be either '+' or '_' indicating whether the observed measure is above the target (overshoot-+) or below the target (undershoot-_). The median value of all performance errors during propofol anesthesia is median performance error and is a measure of bias of the system. This outcome is expressed as the mean of Median Performance Errors per participant.|Approximately 8 hours||||errors per participant||Standard Deviation|Mean
2658136|NCT01600287|Primary|Percentage of Time Bispectral Index(BIS) Remains+/-10 of Target|The primary outcome to be measured is the ability of the system to keep the depth of anesthesia in the target range, i.e, Bispectral Index(BIS) value of 50+/- 10. This will assess the ability of the system to prevent intra-operative awareness of the patients and at the same time avoid excessive depth of anesthesia with its accompanying adverse effects.|Approximately 8 hours||||percentage of time||Standard Deviation|Mean
2658137|NCT01600222|Secondary|Efficacy Evaluation|The percentage of subjects who achieved 'controlled disease' (i.e., Clear or Almost clear) according to the Investigator's Global Assessment (IGA) of disease severity on the trunk, limbs and scalp at Days 28 (Visit 3) and End of treatment (EoT) were presented.|4 weeks I 28 days and End of treatment|"The percentage of subjects achieving controlled disease on Day 28 (n=35) was calculated from the full analysis set.~The percentage of subjects achieving controlled disease at End of Treatment (n=37) was was calculated from the full analysis set using a last observation carried forward approach."|||percentage of subjects|||Number
2658138|NCT01600222|Secondary|Pharmacokinetic Evaluation T1/2|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:~AUC0-t~AUC0-∞~Cmax~Tmax~T½~If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations|||h||Full Range|Mean
2658157|NCT01600105|Secondary|Spleen TTP|"Sub Study III Spleen Time To Peak (TTP) - time to reach peak gadolinium concentration in spleen tissue of interest, derived from DCE-MRI.~Clinically Significant Portal hypertension (CSPH), defined by hepatic venous pressure gradient (HVPG) ≥10 mmHg"|Fasting State Multiparametric MRI Scan (an average of 60 min)|Among the 34 patients, 2 patients did not have DCE-MRI acquisition due to chronic renal insufficiency, 4 patients had non-usable DCE-MRI data because of major artifacts.|||seconds||Standard Deviation|Median
2658139|NCT01600222|Secondary|Pharmacokinetic Evaluation Tmax|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:~AUC0-t~AUC0-∞~Cmax~Tmax~T½~If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented.~All subjects but 1 had plasma concentration of calcipotriol below the LLOQ (lower limit of quantification), and thus it was not possible to calculate group mean of the derived PK parameter based on one sample. Provided values for calcipotriol Tmax are derived from that 1 subject."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations|||h||Full Range|Median
2658140|NCT01600222|Secondary|Pharmacokinetic Evaluation AUCinf|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:~AUC0-t~AUC0-∞~Cmax~Tmax~T½~If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations|||pg/ml||Full Range|Mean
2658141|NCT01600222|Secondary|Pharmacokinetic Evaluation AUClast|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:~AUC0-t~AUC0-∞~Cmax~Tmax~T½~If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented.~All subjects but 1 had plasma concentration of calcipotriol below the LLOQ (lower limit of quantification), and thus it was not possible to calculate group mean of the derived PK parameter based on one sample. Provided values for calcipotriol AUClast are derived from that 1 subject."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations|||pg/ml||Full Range|Mean
2658142|NCT01600222|Secondary|Pharmacokinetic Evaluation Cmax|"The following PK parameters will be calculated, if possible, for each assayed compound based on the obtained plasma concentrations:~AUC0-t~AUC0-∞~Cmax~Tmax~T½~If it is not possible to calculate the above PK parameters, samples with plasma concentration above lower limit of quantification (LLOQ) will be presented.~All subjects but 1 had plasma concentration of calcipotriol below the LLOQ (lower limit of quantification), and thus it was not possible to calculate group mean of the derived PK parameter based on one sample. Provided values for calcipotriol Cmax are derived from that 1 subject."|4 weeks / 28 days|Plasma samples for PK assessment were collected from all 37 subjects however; PK samples from 2 subjects were only collected at screening (SV2) and at Day 14. Therefore these 2 subjects were excluded from PK analysis. Summary of PK parameters based on those subjects that had quantifiable plasma concentrations.|||pg/ml||Full Range|Mean
2658143|NCT01600222|Secondary|Number of Subjects Who Discontinued From the Study|Number of subjects who discontinued from the study due to adverse events.|Baseline to Day 28||||participants|||Number
2658144|NCT01600222|Secondary|Change in Heart Rate From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on vital sign assessments (heart rate).|Baseline and Day 28||||beats/min||Standard Deviation|Mean
2658145|NCT01600222|Secondary|Change in Blood Pressure From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on vital sign assessments (blood pressure).|Baseline and Day 28||||mmHg||Standard Deviation|Mean
2658146|NCT01600222|Secondary|Change in Plasma Parathyroid Hormone (PTH) From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in plasma PTH from Baseline to Day 28.|Baseline and Day 28||||pmol/L||Standard Deviation|Mean
2658147|NCT01600222|Secondary|Change in Serum Alkaline Phosphatase (ALP) From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in serum ALP from Baseline to Day 28.|Baseline and Day 28||||IU/L||Standard Deviation|Mean
2658148|NCT01600222|Secondary|Change in Urinary Phosphate: Creatinine Ratio From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in urinary phosphate:creatinine ratio from Baseline to Day 28.|Baseline and Day 28||||mmol/g||Standard Deviation|Mean
2658149|NCT01600222|Secondary|Change in 24-hour Urinary Phosphate Excretion From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in 24-hour urinary phosphate excretion from Baseline to Day 28.|Baseline and Day 28||||mmol/24H||Standard Deviation|Mean
2658150|NCT01600222|Secondary|Change in Serum Phosphate From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in serum phosphate from Baseline to Day 28.|Baseline and Day 28||||mmol/L||Standard Deviation|Mean
2658151|NCT01600222|Secondary|Number of Participants With an Adverse Drug Reaction (ADR)|"Adverse drug reactions (ADRs) were defined as adverse events for which the investigator has not described the causal relationship to investigational medication as not related."|Baseline to Day 28||||participants|||Number
2658152|NCT01600222|Secondary|Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTH-challenge at Day 28|Serum cortisol concentrations at 30 and 60 minutes after injection were measured in order to assess the maximum stimulated cortisol level achieved. Potential adrenal suppression was indicated if the serum cortisol concentration is ≤18mcg/dl at 30 minutes after the injection.|Day 28||||Subjects|||Number
2658153|NCT01600222|Primary|Change in 24-hour Urinary Calcium:Creatinine Ratio From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in urinary calcium:creatinine ratio from Baseline to Day 28.|Baseline and Day 28||||mmol/g||Standard Deviation|Mean
2658154|NCT01600222|Primary|Change in 24-hour Urinary Calcium Excretion From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in 24-hour urinary calcium excretion from Baseline to Day 28 in 24-hour.|Baseline and Day 28||||mmol/24H||Standard Deviation|Mean
2658155|NCT01600222|Primary|Change in Albumin-corrected Serum Calcium From Baseline to Day 28|The effect of LEO 90100 on calcium metabolism was evaluated based on change in albumin-corrected serum calcium from Baseline to Day 28.|Baseline and Day 28||||mmol/L||Standard Deviation|Mean
2658158|NCT01600105|Secondary|Liver DV|"Sub Study III Liver Distribution Volume (DV) is the distribution volume of contrast agent in the tissue of interest defined as a percentage ratio of gadolinium material volume to the volume of the liver tissue of interest, as derived from DCE-MRI; in the case of a contrast agent with extracellular distribution, DV measures the intravascular and extravascular-extracellular volume.~Clinically Significant Portal hypertension (CSPH), defined by hepatic venous pressure gradient (HVPG) ≥10 mmHg"|Fasting State Multiparametric MRI Scan (an average of 60 min)|Among the 34 patients, 2 patients did not have DCE-MRI acquisition due to chronic renal insufficiency, 4 patients had non-usable DCE-MRI data because of major artifacts.|||percentage of liver volume||Standard Deviation|Median
2658159|NCT01600105|Secondary|LSLU|Sub-Study III Liver Stiffness to Liver Upslope ratio (LSLU) Portal Hypertension is defined as an HVPG ≥5 mmHg Clinically Significant Portal hypertension (CSPH), defined by hepatic venous pressure gradient (HVPG) ≥10 mmHg|Fasting State Multiparametric MRI Scan (an average of 60 min)|31 of the 34 participants had LS-MRE and 28 of the 34 participants had Liver Upslope measurement from DCE-MRI|||kPa*s*L/mmol||Standard Deviation|Median
2658160|NCT01600105|Secondary|PH Imaging Score|"Sub-Study III Portal Hypertension imaging composite score (based on the presence of varices, spleen size, presence of ascites). The imaging score is based on the number of variceal sites (0: absence of varices, 1: one variceal site, 2: two variceal sites, and 3: 3 or more variceal sites), volume of ascites (0: no ascites, 1: minimal perihepatic and perisplenic fluid, 2: intraperitoneal fluid without marked abdominal wall distension, and 3: fluid causing marked abdominal wall distension), and maximum craniocaudal diameter of the spleen (0: size less than 13 cm, 1: size between 13 and 15 cm, 2: size between 15 and 20 cm, and 3: size greater than 20 cm). Score from 0 to 9, with higher score indicating worse disease.~Portal Hypertension is defined as an HVPG ≥5 mmHg Clinically Significant Portal hypertension (CSPH), defined by hepatic venous pressure gradient (HVPG) ≥10 mmHg"|Fasting State Multiparametric MRI Scan (an average of 60 min)|Sub Study III with 34 participants|||score on a scale||Standard Deviation|Median
2658161|NCT01600105|Secondary|Spleen Caudocranial Diameter|Sub-Study III Portal Hypertension is defined as an HVPG ≥5 mmHg|Fasting State Multiparametric MRI Scan (an average of 60 min)|Sub Study III with 34 participants|||cm||Standard Deviation|Median
2658162|NCT01600105|Secondary|Spleen Volume|Sub-Study III Portal Hypertension is defined as an HVPG ≥5 mmHg|Fasting State Multiparametric MRI Scan (an average of 60 min)|Sub Study III with 34 participants|||cm^3||Standard Deviation|Median
2658163|NCT01600105|Secondary|LS-MRE Portal Hypertension for Sub Study III|"Sub-Study III Liver stiffness (LS) measured by magnetic resonance elastography (MRE) in kilopascal (kPa). Liver stiffness is assessed by mathematical modeling of compression waves propagation in the liver, as measured from MRE images.~Portal Hypertension is defined as an HVPG ≥5 mmHg Clinically Significant Portal hypertension (CSPH), defined by hepatic venous pressure gradient (HVPG) ≥10 mmHg"|Fasting State Multiparametric MRI Scan (an average of 60 min)|MRE was successful for liver stiffness measurements in 31 participants of the 34|||kPa||Standard Deviation|Median
2658164|NCT01600105|Secondary|Liver Time to Peak (TTP) for PH|Sub-Study III Liver Time to Peak (TTP) is defined as the time in seconds to reach peak concentration of gadolinium contrast agent in the liver tissue of interest, derived from dynamic contrast‐enhanced MRI (DCE‐MRI) Portal hypertension (PH), defined by hepatic venous pressure gradient (HVPG) ≥5 mmHg Clinically Significant Portal Hypertension is defined as an HVPG ≥10 mmHg|Fasting State Multiparametric MRI Scan (an average of 60 min)|Among the 34 patients, 2 patients did not have DCE-MRI acquisition due to chronic renal insufficiency, 4 patients had non-usable DCE-MRI data because of major artifacts..|||seconds||Standard Deviation|Median
2658165|NCT01600105|Secondary|Liver Upslope From DCE-MRI|"Sub-Study III Liver Upslope of MRI signal is defined as peak concentration to the time to reach peak concentration of gadolinium contrast agent in the liver tissue of interest, derived from dynamic contrast‐enhanced MRI (DCE‐MRI.~Portal hypertension (PH), defined by hepatic venous pressure gradient (HVPG) ≥5 mmHg Clinically Significant Portal hypertension (CSPH), defined by hepatic venous pressure gradient (HVPG) ≥10 mmHg"|Fasting State Multiparametric MRI Scan (an average of 60 min)|Among the 34 patients, 2 patients did not have DCE-MRI acquisition due to chronic renal insufficiency, 4 patients had non-usable DCE-MRI data because of major artifacts.|||mmol/(L.s))||Standard Deviation|Median
2658166|NCT01600105|Primary|MTT|"Sub-Study II Mean Transit Time (MTT) - Liver Mean Transit Time of Contrast Agent through the tissue of interest from Dynamic Contrast Enhanced MRI~Fibrosis State/Score:~F0-F2 - no signs of fibrosis to minimal fibrosis F3-F4 - fibrosis has spread and has connected to other areas on the liver that contain fibrosis or presence of cirrhosis"|Fasting State Multiparametric MRI Scan (an average of 60 min)|Only 50 participants had suitable quality MRI for analysis|||seconds||Standard Deviation|Mean
2658167|NCT01600105|Primary|LS-TE|"Sub-Study II Liver Stiffness with transient elastography (TE) (LS-TE) - a non-invasive modality of liver fibrosis detection: a shear wave is sent into the liver through a small transducer attached to an ultrasound probe, and the velocity of the wave is measured as it passes through the liver; shear wave velocity is then converted to stiffness, measured in kilopascals (kPa)~Fibrosis State/Score:~F0-F2 - no signs of fibrosis to minimal fibrosis F3-F4 - fibrosis has spread and has connected to other areas on the liver that contain fibrosis or presence of cirrhosis"|Fasting transient elastography, average duration 10 min|Only 46 participants had suitable TE quality for analysis.|||kPa||Standard Deviation|Mean
2658168|NCT01600105|Primary|LS-MRE Fibrosis State for Sub Study II|"Sub-Study II Liver stiffness (LS) measured by magnetic resonance elastography (MRE) in kilopascal (kPa). Liver stiffness is assessed by mathematical modeling of compression waves propagation in the liver, as measured from MRE images.~Fibrosis State/Score:~F0-F2 - no signs of fibrosis to minimal fibrosis F3-F4 - fibrosis has spread and has connected to other areas on the liver that contain fibrosis or presence of cirrhosis"|Fasting State Multiparametric MRI Scan (an average of 60 min)|Only 38 participants had suitable MRE quality for analysis.|||kPa||Standard Deviation|Mean
2658169|NCT01600105|Primary|True Diffusion Parameter (D)|"Sub-Study II True Diffusion Parameter - D- describes water diffusion in tissue independently from the effects of capillary perfusion; it is obtained from bi-exponential fitting of MRI diffusion signal acquired over a range of high and low diffusion-weighting factors (b-values)~Fibrosis State/Score:~F0-F2 - no signs of fibrosis to minimal fibrosis F3-F4 - fibrosis has spread and has connected to other areas on the liver that contain fibrosis or presence of cirrhosis"|Fasting State Multiparametric MRI Scan (an average of 60 min) Scan|3 participants with scans not evaluable|||10^-3 mm^2/s||Standard Deviation|Mean
2658170|NCT01600105|Primary|LS-MRE for Sub-Study I|Sub-Study I Liver stiffness (LS) measured by magnetic resonance elastography (MRE) in kilopascal (kPa). Liver stiffness is assessed by mathematical modeling of compression waves propagation in the liver, as measured from MRE images.|Fasting State Scan (an average of 15 min) and Postprandial State Scan (an average of 15 min)|Sub Study I with 30 participants. The method failed in 3 of the patients, so no usable LS-MRE data was generated. 27 patients had usable data for PV flow and velocity, so they were included in the study.|||kPa||Standard Deviation|Mean
2658171|NCT01600105|Primary|PV Velocity|Sub-Study I Portal Venous Flow Velocity - The mean velocity of the region of interest (ROI) was extracted for each one of the 25 phase images, and the time average was computed.|Fasting State Scan (an average of 15 min) and Postprandial State Scan (an average of 15 min)||||cm/s||Standard Deviation|Mean
2658172|NCT01600105|Primary|PV Flow|Sub-Study I Portal Venous Flow - forward flow during systole and early diastole, and flow reversal after atrial contraction.The average PV area was extracted, and PV flow was computed as the multiplication of area and velocity.|Fasting State Scan (an average of 15 min) and Postprandial State Scan (an average of 15 min)||||ml/s||Standard Deviation|Mean
2658173|NCT01600092|Secondary|Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]||Baseline and 42 days after vaccination 3 (up to 185 days)|Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had baseline and follow-up results for the endpoint|||Percentage of participants||95% Confidence Interval|Number
2658174|NCT01600092|Secondary|Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A||42 days after vaccination 3 (up to 185 days)|Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had follow-up results for the endpoint|||Titer||95% Confidence Interval|Geometric Mean
2658175|NCT01600092|Secondary|Number of Participants With Tier-1 Adverse Events: Intussusception|The protocol-defined Tier-1 adverse event to be collected for the duration of the study (up to Day 185) was intussusception|Up to Day 185|Participants who received at least one dose of study vaccine. Participants were assigned to treatment groups based on the vaccine received as the first dose.|||Participants|||Number
2658176|NCT01600092|Secondary|Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. Protocol-defined Tier-1 adverse events to be collected up to 7 days after any vaccination were diarrhea, vomiting, elevated temperature (rectal >=38.1° C, >=100.5° F), and irritability.|Up to 7 days after any vaccination (up to 147 days)|Participants who received at least one dose of study vaccine. Participants were assigned to treatment groups based on the vaccine received as the first dose.|||Participants|||Number
2658177|NCT01600092|Primary|Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]||42 days after vaccination 3 (up to 185 days)|Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had follow-up results for the endpoint|||Titer||95% Confidence Interval|Geometric Mean
2658178|NCT01600053|Secondary|Recording of the Occurrence of Adverse Events||From date of first dose until the date of first documented progression or date of death from any cause, whichever came first|This study has been terminated. Interim analysis showed that the trial will not meet the interim endpoint. Please see adverse event listing for additional information.|||participants|||Number
2658179|NCT01600053|Primary|Eradication of Residual Disease From the Marrow||From date of first dose until then end of 12 cycles of treatment (12 months) or progression of disease, whichever comes first.|This study has been terminated. Interim analysis showed that the trial will not meet the interim endpoint. Data were not collected from the 11 participants before study termination.||||||
2658180|NCT01600014|Secondary|The Change in AK Count From Randomisation to 8 Weeks After Randomisation|The change in AK count from randomisation to 8 weeks after randomisation was determined for the field recalcitrant and the field recurrent subgroups|8 weeks after randomisation||||AK count||Standard Deviation|Mean
2658181|NCT01600014|Secondary|Number of Participants With Complete Clearance Through to Month 12, Defined as no Clinically Visible AKs and no Lesions Treated in the Selected Treatment Area at Any Time From Last Treatment Cycle Through to Month 12|The analysis was done separately for the field recalcitrant subgroup, the field recurrent subgroup, and overall for all treated subject (Analysis 1, 2, and 3, respectively)|From last treatment cycle through to Month 12||||participants|||Number
2658182|NCT01600014|Primary|Number of Participants With Complete Clearance of AKs 8 Weeks After Randomisation|The complete clearance rates 8 weeks after randomisation was compared between ingenol mebutate gel, 0.015% and vehicle gel. Complete clearance was defined as no clinically visible AKs in the Selected Treatment Area (STA)|8 weeks after randomisation||||participants|||Number
2658183|NCT01599832|Other Pre-specified|Progression-free Survival|Specifically, whether baseline K^trans is associated with progression-free survival. Progression was assessed using Response Evaluation Criteria in Solid Tumors (Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum recorded since the treatment started OR the appearance of one or more new lesions OR unequivocal progression of existing non-target lesions)|2 years|Included those with a baseline K^trans value|||weeks||Full Range|Median
2658184|NCT01599832|Secondary|Changes in sVEGFR2 From Baseline to Post-treatment||Baseline and 1 week post-treatment|Data not collected||||||
2658185|NCT01599832|Secondary|Changes in Blood Pressure From Baseline to Post-treatment||Baseline and 1 week post-treatment|Data were not collected||||||
2658186|NCT01599832|Secondary|Change in K^Trans From Baseline|K^trans is a derived measure from dynamic contrast-enhanced magnetic resonance imaging that reflects perfusion rate and capillary permeability. The change is reported as the log-transformed ratio of K^trans value at follow-up/baseline.|Baseline and 1, 8, 16, and 24 weeks post-treatment|Included those with a baseline K^Trans value and at least 1 K^trans value at follow-up|||unitless [log(ratio)]||Standard Deviation|Mean
2658890|NCT01593787|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8||baseline, 8 weeks|FAS|||mmHg||Standard Deviation|Mean
2658187|NCT01599832|Primary|Disease Progression|Specifically, whether the change in K^trans (the rise from nadir) as a time-dependent covariate, as assessed by the method described in Donner, is associated with disease progression.Progression was assessed using Response Evaluation Criteria in Solid Tumors (Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum recorded since the treatment started OR the appearance of one or more new lesions OR unequivocal progression of existing non-target lesions)|2 years|The accrued sample size of n=20 did not permit further assessment (as described in the Outcome Measure Description) of the primary endpoint, so simply reporting the median progression-free survival here|||weeks||Full Range|Median
2658188|NCT01599806|Secondary|Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 300 to 360 minutes after dose|PK analysis set (avibactam between 300 to 360 minutes after dose)|||NG/ML||Full Range|Geometric Mean
2658189|NCT01599806|Secondary|Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 30 to 90 minutes after dose|PK analysis set (avibactam between 30 to 90 minutes after dose)|||NG/ML||Full Range|Geometric Mean
2658190|NCT01599806|Secondary|Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|within 15 minutes before/after dose|PK analysis set (avibactam within 15 minutes before/after dose)|||NG/ML||Full Range|Geometric Mean
2658191|NCT01599806|Secondary|Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 300 to 360 minutes after dose|PK analysis set (ceftazidime between 300 to 360 minutes after dose)|||NG/ML||Full Range|Geometric Mean
2658192|NCT01599806|Secondary|Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 30 to 90 minutes after dose|PK analysis set (ceftazidime between 30 to 90 minutes after dose)|||NG/ML||Full Range|Geometric Mean
2658193|NCT01599806|Secondary|Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|within 15 minutes before/after dose|PK analysis set (ceftazidime within 15 minutes before/after dose)|||NG/ML||Full Range|Geometric Mean
2658194|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participant|||Number
2658195|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Extended microbiological evaluable analysis set at TOC (EME at TOC)|||Participant|||Number
2658196|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
2658197|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participant|||Number
2658198|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Extended microbiological evaluable analysis set at TOC (EME at TOC)|||Participant|||Number
2658199|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
2658200|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)|||Participant|||Number
2658201|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participant|||Number
2658202|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))|||Participant|||Number
2658203|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (EME at LFU)|||Participant|||Number
2658204|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (EME at TOC)|||Participant|||Number
2658205|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))|||Participant|||Number
2658206|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
2658207|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
2658208|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
2658209|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)|||Participant|||Number
2658210|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participant|||Number
2658211|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))|||Participant|||Number
2658212|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (EME at LFU)|||Participant|||Number
2658213|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (EME at TOC)|||Participant|||Number
2658214|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))|||Participant|||Number
2658215|NCT01599806|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
2658216|NCT01599806|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
2658217|NCT01599806|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
2658218|NCT01599806|Secondary|Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Clinically evaluable analysis set at TOC(CE at TOC)|||Participants|||Number
2658219|NCT01599806|Secondary|Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)|||Participants|||Number
2658220|NCT01599806|Secondary|Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Microbiological evaluable analysis set at TOC(ME at TOC)|||Participants|||Number
2658302|NCT01599585|Secondary|Beck Hopelessness Scale (BHS)|The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.|3 month follow up||||units on a scale||Standard Deviation|Mean
2658221|NCT01599806|Secondary|Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)|Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658222|NCT01599806|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)|||Participants|||Number
2658223|NCT01599806|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC(ME at TOC)|||Participants|||Number
2658224|NCT01599806|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658225|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)|||Participants|||Number
2658226|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC(ME at TOC)|||Participants|||Number
2658227|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658228|NCT01599806|Secondary|Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Clinically evaluable analysis set at LFU (CE at LFU)|||Participants|||Number
2658229|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Clinically evaluable analysis set at TOC (CE at TOC)|||Participants|||Number
2658230|NCT01599806|Secondary|Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Clinically evaluable analysis set at EOT (IV) (CE at EOT (IV))|||Participants|||Number
2658231|NCT01599806|Secondary|Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)|||Participants|||Number
2658232|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)|||Participants|||Number
2658233|NCT01599806|Secondary|Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (Extended ME at EOT (IV))|||Participants|||Number
2659436|NCT01588496|Secondary|Part A: Percentage of Participants With 15% or Greater Reduction in LDL-C From Baseline at Week 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Week 12|Part A full analysis set|||percentage of participants|||Number
2658234|NCT01599806|Secondary|Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)|||Participants|||Number
2658235|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC )|||Participants|||Number
2658236|NCT01599806|Secondary|Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))|||Participants|||Number
2658237|NCT01599806|Secondary|Investigator Determined Clinical Response at LFU (mMITT Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658238|NCT01599806|Secondary|Investigator Determined Clinical Response at TOC (mMITT Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658239|NCT01599806|Secondary|Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658240|NCT01599806|Secondary|Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)|||Participants|||Number
2658241|NCT01599806|Secondary|Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)|Number of patients with a favorable per patient microbiological response at TOC|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)|||Participants|||Number
2658242|NCT01599806|Secondary|Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))|||Participants|||Number
2658243|NCT01599806|Secondary|Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)|||Participants|||Number
2658244|NCT01599806|Secondary|Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)|Number of patients with a favorable per patient microbiological response at TOC|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participants|||Number
2658245|NCT01599806|Secondary|Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))|||Participants|||Number
2658246|NCT01599806|Secondary|Per-patient Microbiological Response at LFU (mMITT Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658247|NCT01599806|Secondary|Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658248|NCT01599806|Primary|Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658996|NCT01592383|Secondary|EGFR Mutations Percentage|EGFR Mutations Percentage is calculated as the percentage of patients who have activating EGFR mutations among all screened patients.|Baseline|The study was terminated early after the enrollment of two participants and the data were not collected.||||||
2658249|NCT01599806|Primary|Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658250|NCT01599806|Primary|Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).|At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658251|NCT01599793|Secondary|Change in Pain Scale Between 12 Weeks and Baseline|"Pain scores are measured at baseline and weeks 12, and 24. Change between baseline and 12 weeks are reported .~In the pain score ranged from 0 to 10. 10 denotes most pain."|baseline,12 weeks|At 12 weeks, 3 individual have missing pain score data.|||score on a scale||Standard Deviation|Mean
2658252|NCT01599793|Secondary|Correlation of Percent Change in the Functional MRI Metrics With CTC|The protocol proposed to collect CTC measurements at weeks 0, 12, and 24. However, the data were not collected|baseline, 12 weeks, and 24 weeks|data on CTC were not collected||||||
2658253|NCT01599793|Secondary|Change of PSA Between 12 Weeks and Baseline|PSA at weeks 0, 12, and 24 were collected. Change between baseline and 12 weeks are reported|baseline, 12 weeks|At 12 weeks, 4 individual have missing PSA data.|||ng/mL||Standard Deviation|Mean
2658254|NCT01599793|Secondary|Correlation of Percent Change in the Functional MRI Metrics to RECIST Tumor Measurements|"The protocol proposed to collect RECIST tumor measurements at weeks 0, 12, and 24.~However, the data were not collected"|baseline, 12 weeks, and 24 weeks|Data on RECIST tumor measurements were not collected||||||
2658255|NCT01599793|Secondary|Changes in Bone Scan Response|Bone Scan Response at weeks 2, 12, and 24 were collected. Change between baseline and 2 weeks are reported Bone Scan Response were measured as increase, decrease, or stable of bone lesions and scored as 1, -1, or 0, respectively, where higher values represent a worse outcome.|baseline, 2 weeks|6 individual have missing bone lesions data.|||score on a scale||Standard Deviation|Mean
2658256|NCT01599793|Secondary|Association of Progression Free Survival (PFS) With Ktrans and ADC|"Time to progression or progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.~The approximate survival after standard therapies in this setting is bleak and in the order of months.~Too few events for a meaningful statistical analysis; no significant results were obtained in Cox regression analyses.~Therefore, we calculated the median PFS time and its 95% confidence interval."|From start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year||||month||95% Confidence Interval|Median
2658257|NCT01599793|Primary|Change in the Functional MRI Metrics Ktrans Between 2 Weeks and Baseline|"Ktrans is a measurement calculating the volume transfer constant of the contrast reagent and essentially is a measurement of vascular perfusion.~To determine the effect of XL184 on the functional MRI metrics Ktrans, Ktrans parameters were measured at baseline, two week time-point, 12 weeks, and 24 weeks for disease monitoring. Change between baseline and 2 weeks reported."|baseline, 2 weeks|2 individuals had missing values for Ktrans from baseline to 24 weeks|||per minute (or min-1)||Standard Deviation|Least Squares Mean
2658258|NCT01599754|Secondary|Number of Participants With Laboratory Abnormalities: Urinalysis|Number of participants with urine protein dipstick grading: negative/trace (5 to 20 milligram per deciliter [mg/dL]), 1+ (30 mg/dL]), 2+ (100 mg/dL), 3+ (300 mg/dL) and 4+ (more than 1000 mg/dL) are reported.|From Day 1 up to 28 days after last dose (maximum duration of 3 years)|"As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||Participants|||Count of Participants
2658259|NCT01599754|Secondary|Number of Participants With Laboratory Abnormalities: Thyroid Function|Number of participants with thyrotropin levels: <5 milli-international units per litre (mIU/L), >=5 to <10 mIU/L, >=10 mIU/L are reported.|From Day 1 up to 28 days after last dose (maximum duration of 3 years)|"As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure."|||Participants|||Count of Participants
2658260|NCT01599754|Secondary|Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Chemistry|Chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatine phosphokinase increased, creatinine increased, hypoalbuminemia, hypercalcemia, hypocalcemia, hyperglycemia, hypoglycemia, hyperkalemia, hypokalemia, hypernatremia, hyponatremia. CTCAE grades: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).|From Day 1 up to 28 days after last dose (maximum duration of 3 years)|"As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, number analyzed signifies number of participants evaluable for specified categories."|||Participants|||Count of Participants
2658303|NCT01599585|Secondary|Beck Hopelessness Scale (BHS)|The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.|Midpoint- Week 4||||units on a scale||Standard Deviation|Mean
2658261|NCT01599754|Secondary|Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology|Hematology parameters included anemia, hemoglobin increased, lymphocyte count increased, lymphocyte count decreased, neutrophil count decreased, platelet count decreased, and white blood cell count decreased. CTCAE grades: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).|From Day 1 up to 28 days after last dose (maximum duration of 3 years)|"As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Here, number analyzed signifies number of participants evaluable for specified categories."|||Participants|||Count of Participants
2658262|NCT01599754|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) By Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AE was assessed according to severity as: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).|From Day 1 up to 28 days after last dose (maximum duration of 3 years)|As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||Participants|||Count of Participants
2658263|NCT01599754|Secondary|Number of Participants With Treatment‑Emergent Treatment Related Adverse Events and Serious Adverse Events (SAEs)|A treatment related AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event had a causal relationship with the treatment or usage. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness was judged by investigator. AEs included both serious and non-serious adverse events.|From Day 1 up to 28 days after last dose (maximum duration of 3 years)|As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||Participants|||Count of Participants
2658264|NCT01599754|Secondary|Number of Participants With Treatment‑Emergent Adverse Events (AE) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|From Day 1 up to 28 days after last dose (maximum duration of 3 years)|As-Treated population included all participants who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.|||Participants|||Count of Participants
2658265|NCT01599754|Secondary|Overall Survival (OS)|OS defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. Participants lacking data beyond randomization had their survival times censored at randomization.|From randomization date until death due to any cause (up to 5 years)|ITT population included all randomized participants regardless of whether or not treatment was administered and based on randomized treatment assignment.|||years||95% Confidence Interval|Median
2658266|NCT01599754|Primary|Disease Free Survival (DFS) as Assessed by Blinded Independent Review Committee (IRC)|DFS is defined as time interval from the date of randomization to first date of recurrence/relapse (distant or local recurrence of [RCC] or occurrence of a secondary malignancy {occurrence of a second primary cancer other than RCC} or death). For participants with no DFS event, DFS was censored at date of last scan prior to time of analyses. Participants alive who did not have post-baseline disease assessments, DFS was censored at randomization. Participants who received further anti-tumor therapy prior to recurrence or occurrence of a secondary malignancy or death, DFS was censored on date of last scan prior to taking anti-tumor medication. Participants who missed 2 or more consecutive tumor scans immediately followed by an event were censored at date of last objective tumor assessment prior to missing/not readable scan.|From randomization date up to first date of recurrence or the occurrence of a secondary malignancy or death (up to 5 years)|ITT population included all randomized participants regardless of whether or not treatment was administered and based on randomized treatment assignment.|||years||95% Confidence Interval|Median
2658267|NCT01599741|Secondary|Radiation Dose Measurements: Air Kerma (AK)|"Percentage dose change of ClarityIQ vs. AlluraXper in AK calculated by AK/frame for DSA. Negative change means a reduction in dose for ClarityIQ vs. AlluraXper.~AK was measured during the ClarityIQ and AlluraXper runs during the procedure."|Participants were followed for the duration of the procedure|All patients with recorded dose information from the system for both DSA runs were used.|||percentage of dose change||Standard Deviation|Mean
2658268|NCT01599741|Secondary|Radiation Dose Measurements: Dose Area Product (DAP)|"Percentage dose change of ClarityIQ vs. AlluraXper in DAP calculated by DAP/frame for DSA. Negative change means a reduction in dose for ClarityIQ vs. AlluraXper.~DAP was measured during the ClarityIQ and AlluraXper runs during the procedure."|Participants were followed for the duration of the procedure|All patients with recorded dose information from the system for both DSA runs were used.|||percentage of dose change||Standard Deviation|Mean
2658269|NCT01599741|Primary|Image Quality|Overall proportion where diagnostic image quality of ClarityIQ is scored equal or better compared to AlluraXper by the blinded reviewers. Reading is performed by simultaneous visual comparison of image quality of AlluraXper and ClarityIQ by multiple blinded readers. All blinded readers have rated all side-by-side presented images. The images are presented in a random order and blinded to the reader. The hypothesis is that the overall proportion where diagnostic image quality of ClarityIQ is scored equal or better is ≥ than 0.80. Combined for all raters, the lower bound of the one-sided 95% CI (lower bound of the two-sided 90% CI) is used.|1 Day|All patients with recorded dose information from the system for both DSA runs were used.|||Proportion of images rated equal/better||90% Confidence Interval|Mean
2658270|NCT01599650|Secondary|BCVA (Letters) Mean Average Change From First Ranibizumab Treatment to Month 24 in the Study Eye for Patients Randomized to the Laser Monotherapy Arm|"Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)~-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model."|Month 24|Randomized set|||BCVA letters||Standard Deviation|Mean
2658271|NCT01599650|Secondary|The Mean Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 6 and Month 24 Compared to Baseline|The survey consists of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. All items are scored so that a high score represents better functioning. Each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively. In this format scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score.|Months 6 and 24||||score on a scale||Standard Deviation|Mean
2658272|NCT01599650|Secondary|The Mean Change in Central Reading Center-assessed Central Subfield Thickness From Month 12 and Month 24 vs. Baseline by Treatment Arm|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation. Stratification was done based on categories of baseline best corrected visual acuity & analysis was based on analysis of variance (ANOVA)|Month 12 and Month 24||||microns||Standard Error|Mean
2658273|NCT01599650|Secondary|Number of Patients With a BCVA Improvement vs Baseline or Achieved Greater Than or Equal to 73 Letters at Month 24 in the Study Eye|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 24 indicates a positive outcome.|Month 24||||participants|||Number
2658274|NCT01599650|Secondary|Number of Patients With a BCVA Improvement vs Baseline or Achieving Greater Than or Equal to 73 Letters at Month 6 in the Study Eye|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and Month 6 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 6 indicates a positive outcome.|Month 6||||participants|||Number
2658275|NCT01599650|Secondary|The Percent of Patients With a Visual Acuity Gain of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline up to Month 6 and Month 24, by Visit|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 6 & Month 24 as compared with baseline, was assessed by an ANOVA model. Endpoints related to the proportion of patients with BCVA letter gain or loss from Baseline was analyzed via stratified Cochran-Mantel-Haenszel test with stratification based on baseline BCVA (baseline BCVA less than or equal to 39, 40 to 59, greater than or equal to 60 letters, treatment groups).|Baseline, Month 6 and Month 24||||percent patients gaining improvement|||Number
2658276|NCT01599650|Secondary|The Mean Change in Visual Acuity BCVA (Letters) From Baseline at Month 12 and Month 24|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and Month 24 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and were assessed by an ANOVA model.|Baseline, Month 12 and Month 24|Full Analysis set|||letters||Standard Deviation|Mean
2658277|NCT01599650|Secondary|Mean Average Change in Visual Acuity (BCVA Letters) From Month 1 Through Month 6|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters.(A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 6. Then, mean average change is calculated as the average of average changes across all patients.|From Baseline through Month 6||||letters||Standard Deviation|Mean
2658278|NCT01599650|Secondary|Number of Ranibizumab Treatments From Day 1 to Month 23 by Treatment Group|Number of injections provided to the patients during the 23 month period and conducted within FAS with LOCF and observed data.|Day 1 through Month 23||||treatments||Standard Deviation|Mean
2658279|NCT01599650|Secondary|The Mean Average Change in Visual Acuity From Month 1 Through Month 24 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. (A positive average change from baseline of BCVA indicates improvement): Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 24. Then, mean average change is calculated as the average of average changes across all patients.|Baseline, 24 Months|analysis for change consists of the group that had a baseline and 24 month data point|||letters||Standard Deviation|Mean
2658280|NCT01599650|Primary|Mean Change in Visual Acuity: BCVA Change at Month 6 Compared to Baseline in Patients With Visual Impairment Due to Branch Retinal Vein Occlusion (BRVO)|"Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)~-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 6 compare to Baseline, the 95% confidence interval and P value (related to the null hypothesis that this mean change is equal to zero) based on a t distribution/t test were calculated and assessed by an ANOVA model."|Baseline, 6 Months|analysis for change consists of the group that had a baseline and 6 month data point|||letters||Standard Deviation|Mean
2658281|NCT01599637|Secondary|Chronic Urticaria Quality of Life Questionnaire (Cu-Q2OL) by Treatment|The Cu-Q2OL is a 23-item CIU-specific health-related quality of life questionnaire. Patients rated their CIU symptoms and the impact of their CIU on various aspects of their lives. An overall score was calculated as well for the following domains: pruritus, swelling, impact on life activities, sleep problems, limits, and looks. Zero is the minmum score and 100 the maximum score. The higher score correlates to more disease activity.|Baseline and Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data|||score||Standard Deviation|Mean
2658282|NCT01599637|Secondary|Skindex-29 by Treatment|The Skindex-29 is a validated 29-item instrument to measure the effects of skin disease on patients' quality of life.Results are reported as 3 scale scores (functioning, emotions and symptoms) and a composite score (average scale score). The domain scores and the overall score are expressed on a 100-point scale, with higher scores indicating a lower level of quality of life. The cuttoff values for each category are noted below. Symtoms; 39 mild, 42 moderate,52 severe. Emotions; 24 mild, 35 moderate, 39 severe. Functioning: 21 mild, 32 moderate, 37 severe. Overal Score: 25 mild, 32 moderate, 44 severe.|Baseline and Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data|||Score||Standard Deviation|Mean
2658283|NCT01599637|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) by Treatment|The DLQI is a 10-item dermatology-specific health-related quality of life measure. Patients rated their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives. An overall score was calculated as well as for the following domains: Symptoms and Feelings, Daily Activities, Leisure, Work and School, Personal Relationships, Treatment.Negative score shows positive efficacy. Meaning of DLQI Scores 0-1 = no effect at all on patient's life 2-5 = small effect on patient's life 6-10 = moderate effect on patient's life 11-20 = very large effect on patient's life 21-30 = extremely large effect on patient's life. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.|Baseline through Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data|||Score||Standard Deviation|Mean
2658284|NCT01599637|Secondary|Percentage of Angioedema-free Days Weeks 4 Through 12 by Treatment||Day 29 to Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data|||Percentage of days||Standard Deviation|Mean
2658285|NCT01599637|Secondary|Likert Scale-Physician's and Patients In-clinic Global Assessment by Treatment|The investigator or the person he or she designated and the patient provided scoring of the patient's global assessment of symptoms (urticaria lesions (hives) and pruritus) reflective of the patient's condition over the 12 hours prior to the visit (0 = no symptoms, 1 = mild, 2 = moderate 3 = severe|Baseline, Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data|||score||Standard Deviation|Mean
2658286|NCT01599637|Secondary|Change From Baseline in Urticaria Activity Score (UAS7)|Efficacy was assessed by the urticaria activity score (UAS). UAS was completed each morning and evening on a daily basis to record patient symptoms of itch and hives via an electronic diary. The UAS is a composite eDiary−recorded score with numeric severity intensity ratings on a scale of 0−3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease. A negative change score (Week 12 score minus Baseline score) indicates improvement.|Baseline, Day 85|Efficacy analysis set which included all randomized patients who received at least one dose of study drug and had post-randomization efficacy data. If the Week 12 value was missing, it was imputed as the last available UAS7 value (LOCF).|||units on a scale||Standard Deviation|Mean
2658287|NCT01599637|Secondary|Summary Statistics of Observed Values and Absolute Change From Baseline in Specific IgE Against Allergens and Bacterial Antigens by Parameter, Treatment and Visit||Baseline through Day 140|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.|||IU/mL||Standard Deviation|Mean
2658288|NCT01599637|Secondary|Mean (SD) Serum Free IgE % Change From Baseline by Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.|||% change||Standard Deviation|Mean
2658289|NCT01599637|Secondary|Mean (SD) Serum Free IgE Concentration From Baseline by Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.|||ng/mL||Standard Deviation|Mean
2658290|NCT01599637|Secondary|Mean (SD) Serum Total IgE % Change From Baseline by Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.|||Percent Change from Baseline||Standard Deviation|Mean
2658291|NCT01599637|Secondary|Mean (SD) Serum Total IgE Concentration From Baseline by Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.|||ng/mL||Standard Deviation|Mean
2658292|NCT01599637|Secondary|Serum Levels of Omalizumab|Serum concentrations (ng/mL) of omalizumab by visit after the administration of omalizumab 300 mg every 4 weeks|Baseline through Day 85|PK analysis set which included all subjects who received at least one dose of study drug and had evaluable IGE025 concentrations.|||ng/mL||Standard Deviation|Mean
2658293|NCT01599637|Secondary|Comparison of Baseline PD Parameters Between Healthy Volunteers and Urticaria Patients by Skin Layer Pharmacodynamic Analysis Set|The # positive cell values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2|Baseline|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis|||# positive cells||Standard Deviation|Mean
2658294|NCT01599637|Secondary|Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured in Fluorescence Units.|Fluorescence-activated cell sorting (FACS) is a specialized type of flow cytometry that provides a method for sorting a heterogeneous mixture of biological cells into two or more containers, one cell at a time, based upon the specific light scattering and fluorescent characteristics of each cell. (FACS) provides fast, objective and quantitative recording of fluorescent signals from individual cells as well as physical separation of cells of particular interest. A wide range of fluorophores can be used as labels in flow cytometry. Fluorophores are typically attached to an antibody that recognizes a target feature on or in the cell; they may also be attached to a chemical entity with affinity for the cell membrane or another cellular structure. Each fluorophore has a characteristic peak excitation and emission wavelength.|Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.• FACS parameters: FceRI expression on basophils and IgE bound, FceR2 expression on B cells and IgE bound, and FceRI expression on dendritic cells|||Flourescence units||Standard Deviation|Mean
2658295|NCT01599637|Secondary|Observed Values and Change From Baseline in Peripheral Blood Cell Subsets (FACS Parameters) at Week 12 (Day 85) by Treatment (PD Analysis Set) Measured as % Out of Leukocytes.|Fluorescence-activated cell sorting (FACS) is a specialized type of flow cytometry that provides a method for sorting a heterogeneous mixture of biological cells into two or more containers, one cell at a time, based upon the specific light scattering and fluorescent characteristics of each cell. (FACS) provides fast, objective and quantitative recording of fluorescent signals from individual cells as well as physical separation of cells of particular interest. A wide range of fluorophores can be used as labels in flow cytometry. Fluorophores are typically attached to an antibody that recognizes a target feature on or in the cell; they may also be attached to a chemical entity with affinity for the cell membrane or another cellular structure. Each fluorophore has a characteristic peak excitation and emission wavelength.|Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.|||% out of leukocytes||Standard Deviation|Mean
2658296|NCT01599637|Secondary|Observed Values From Baseline Through End of Study of Serum Chemkines or Histamine in Peripheral Blood Cells by Parameter, Treatment and Visit||Baseline through Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis.|||ug/mL||Standard Deviation|Mean
2658297|NCT01599637|Secondary|Observed Values and Absolute Change From Baseline in Skin Cell Subsets (CD3, CD4, CD8, Eosinophils, DCs, and Mast Cells) by Parameter, Skin Layer, Lesion Status, Treatment and Visit|The average number of cells derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2|Baseline to Day 85|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis. Day 29 was an optional sampling time point in this paramter. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2|||# positive cells||Standard Deviation|Mean
2658298|NCT01599637|Secondary|Correlation of Change From Baseline in IgE on Positive Skin Cells With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status|Correlation of primary endpoint with The UAS7 which is a composite eDiary−recorded score with numeric severity intensity ratings on a scale of 0−3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease.|Baseline through Day 85|Efficacy analysis set: Includes all randomized patients who received at least one dose of study drug and have post-randomization efficacy data.|||correlation coefficient|||Number
2658299|NCT01599637|Secondary|Correlation of Change From Baseline in IgE Receptor FceRI With Change From Baseline in UAS7 at Week 12 by Treatment, Skin Layer and Lesion Status|Correlation of primary endpoint with The UAS7 which is a composite eDiary−recorded score with numeric severity intensity ratings on a scale of 0−3 (0 = none to 3 = intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch. The daily UAS is the average of the morning and evening scores and the UAS7 is the sum of the daily UAS scores over 7 days.UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. If fewer than 7 but at least 4 daily values were non-missing, the remaining values were imputed to be the average. This is equivalent to multiplying the average of the non missing values by 7. UAS7 score: The sum of the daily UAS scores over 7 days. Range: 0-42. A higher score indicates worse disease.|Baseline through Day 85|Efficacy analysis set: Includes all randomized patients who received at least one dose of study drug and have post-randomization efficacy data.|||correlation coefficient|||Number
2658300|NCT01599637|Primary|Observed Values and Absolute Change From Baseline in IgE Positive Skin Cells: Dermis, Lesional and Non Lesional Skin|Observed values and absolute change in IgE positive skin cells: dermis non-lesional and lesional The primary variable for this study was the relative change from baseline in IgE positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment. The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2|Baseline through Day 85 post-treatment|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis. Patients with both baseline and week 12 data were included in this analysis|||IgE positive skin cells||Standard Deviation|Mean
2658301|NCT01599637|Primary|Observed Values and Absolute Change From Baseline in FceRI Positive Skin Cells: Dermis, Lesional and Non Lesional Skin|Observed values and absolute change in FcεRI positive skin cells: dermis non-lesional and lesional. The primary variable for this study was the relative change from baseline in the high affinity IgE receptor (FcεRI) positive skin cells, based on skin biopsies collected from patients with CIU after 12 weeks of treatment.The values are average of cell numbers derived from counting 5 consecutive microscopic fields. Area counted is 5x 0.196 mm2|Baseline through Day 85 post-treatment|All subjects who received at least one dose of study drug and had evaluable pharmacodynamic (PD) data were included in the PD data analysis. Patients with both baseline and week 12 data were included in this analysis|||FcεRI positive skin cells||Standard Deviation|Mean
2658306|NCT01599585|Secondary|Beck Depression Inventory -II (BDI-II)|The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.|Post Treatment- Week 8||||units on a scale||Standard Deviation|Mean
2658307|NCT01599585|Secondary|Beck Depression Inventory -II (BDI-II)|The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome|Midpoint- Week 4||||units on a scale||Standard Deviation|Mean
2658308|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|3 month follow up|Adverse event data is recorded in adverse event section|||participants|||Number
2658309|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 8|Adverse event data recorded in adverse event section|||participants|||Number
2658310|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 7|adverse events are reported in adverse event section|||participants|||Number
2658311|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 6|adverse events are reported in the adverse event section|||participants|||Number
2658312|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 5|adverse events are reported in adverse event section|||participants|||Number
2658313|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 4|Adverse Event data recorded in Adverse event section|||participants|||Number
2658314|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 3|adverse event data reported in adverse event section|||participants|||Number
2658315|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 2|adverse event data reported in adverse event section|||participants|||Number
2658316|NCT01599585|Secondary|Beck Depression Inventory -II (BDI-II)|The BDI-II is the most commonly used self-report measure of clinical depression severity. It consists of 21 items that are rated on a 4-point scale which yield a range of scores from 0 - 63. The BDI-II has sound psychometric properties. The higher the score the worse the outcome.|Baseline||||units on a scale||Standard Deviation|Mean
2658317|NCT01599585|Secondary|Adverse Events|Safety data will be collected on adverse events, psychiatric hospitalizations, suicides and non-fatal suicide-related behaviors, number of times the treatment collateral was utilized during treatment, treatment adherence, participant drop-out rate, and frequency of requests for patient or therapist technical support. Safety related data will be recorded after each treatment session on the Treatment Session Checklist.|Treatment Session Week 1|AE data reported in adverse events section|||participants|||Number
2658318|NCT01599585|Primary|Beck Hopelessness Scale (BHS)|The BHS is a 20-item scale for measuring negative attitudes about the future. Each item is scored with a true/false response. Total scores range from 0-20 with higher scores indicating a greater degree of hopelessness.|Post treatment - Week 8||||units on a scale||Standard Deviation|Mean
2658329|NCT01599325|Secondary|The Number of Infections (Post-baseline Average) Requiring Intravenous (IV) Antibiotics, Anti-fungals, or Antivirals by Cycle|The on-treatment adverse event of infection requiring IV antibiotics, antifungals, or antivirals per 28 days/cycle. The overall post-baseline average is the average of number of infections requiring IV antibiotics or IV antiviral per 28 days/cycle.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.|||Infections||Standard Deviation|Mean
2658319|NCT01599325|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Extension Phase|A treatment-emergent adverse events (TEAE) was defined as AEs with an onset date on or after the date of first dose and within 28 days after the date of the last dose. Any AE that occurred beyond this timeframe and was assessed by the investigator as possibly related to study drug was considered treatment-emergent. The intensity and severity of AEs was assessed by the investigator according to the Common Terminology Criteria for Adverse Event (CTCAE) Version 4.0. For any AEs not listed in the CTCAE grading system, the intensities of these events was assessed by the Investigator using the 5-point scale: Grade 1 = Mild, Grade 2 = Moderate; Grade 3 = Severe, Grade 4 = Life threatening, Grade 5 = Death. An SAE is any AE occurring that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and constitutes an important medical event.|Up to final data cut off date of 25 April 2018; from the first dose of study drug extesnion of 29 December 2014 to 28 days after the date of the last dose of study drug; median duration of any dose of study drug was 169 days|Safety population included all participants who received at least one dose of azacitidine and had at least one post-dose safety assessment|||participants|||Number
2658320|NCT01599325|Secondary|Apparent Volume of Distribution (Vd/F) of Azacitidine|Apparent volume of distribution, was calculated according to the equation: Vd/F = (CL/F)/λz|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2658321|NCT01599325|Secondary|Apparent Total Plasma Clearance (CL/F) of Azacitidine|Apparent total plasma clearance (CL/F) of Azacitidine was calculated as Dose/AUC∞|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.|||Liters/hours||Geometric Coefficient of Variation|Geometric Mean
2658322|NCT01599325|Secondary|Terminal Phase of Half-life (T1/2) of Azacitidine|The apparent terminal half-life was calculated according to the following equation t½ = 0.693/λz.|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.|||hours||Geometric Coefficient of Variation|Geometric Mean
2658323|NCT01599325|Secondary|Time to Maximum Plasma Concentration (Tmax) of Azacitidine|Time to maximum observed plasma concentration obtained directly from the observed concentration versus time data.|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.|||hours||Full Range|Median
2658324|NCT01599325|Secondary|Maximum Observed Plasma Concentration (Cmax) of Azacitidine|The observed maximum plasma concentration obtained directly from the observed concentration versus time data.|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2658325|NCT01599325|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Azacitidine|Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2658326|NCT01599325|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Azacitidine|Area under the plasma concentration-time curve from time zero to infinity (AUC∞) following multiple doses of Azacitidine on Day 7; if possible, the area under the concentration-time curve from time zero to infinity, calculated by the linear trapezoidal rule and extrapolated to infinity was calculated according to the following equation: AUC∞ = AUCt + (Ct/ λz ), where Ct is the last quantifiable concentration. No AUC extrapolation will be performed with unreliable λz. If % AUC extrapolated is ≥ 25%, AUC∞ will not be reported|PK blood samples collected at 0.25, 0.5, 1,2,3,4, 6 and 8 hours after azacitidine administration on Day 7|The PK population includes up to 12 participants with evaluable azacitidine plasma PK profile.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2658327|NCT01599325|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Parent Phase|A treatment-emergent adverse events (TEAE) was defined as AEs with an onset date on or after the date of first dose and within 28 days after the date of the last dose. Any AE that occurred beyond this timeframe and was assessed by the investigator as possibly related to study drug was considered treatment-emergent. The intensity and severity of AEs was assessed by the investigator according to the Common Terminology Criteria for Adverse Event (CTCAE) Version 4.0. For any AEs not listed in the CTCAE grading system, the intensities of these events was assessed by the Investigator using the 5-point scale: Grade 1 = Mild, Grade 2 = Moderate; Grade 3 = Severe, Grade 4 = Life threatening, Grade 5 = Death. An SAE is any AE occurring that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and constitutes an important medical event.|Up to 29 January 2015; from the first dose of study drug to 28 days after the date of the last dose of study drug (maximum time on study was 244 days)|Safety population included all participants who received at least one dose of azacitidine and had at least one post-dose safety assessment|||participants|||Number
2658328|NCT01599325|Secondary|Kaplan Meier Estimates for Overall Survival (OS)|Overall survival is defined as time to death from any cause, is calculated using date of first dose and date of death, or date of last follow-up for censored participants. Those, who die regardless of the cause of death, will be considered to have an event.|Until the end of the survival follow-up period; Up to data cut-off of 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.|||months||95% Confidence Interval|Number
2658407|NCT01598311|Primary|Percentage of Participants Discontinuing From Study Treatment Due to an AE|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.|Up to EOT (up to Day 10)|The analysis population consists of all randomized and treated participants (Safety Population).|||Percentage of Participants|||Number
2658330|NCT01599325|Secondary|The Number of RBC Transfusions by Cycle|The number of RBC transfusions received 56 days prior to treatment, considered the baseline period (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for platelets. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.|||RBC Transfusions||Standard Deviation|Mean
2658331|NCT01599325|Secondary|The Number of Units of Red Blood Cell (RBC) Transfusions by Cycle|The number of units of RBC received 56 days prior to treatment, considered the baseline period (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for RBC. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|ITT includes all participants who were enrolled into the study|||Units of RBC Transfusions||Standard Deviation|Mean
2658332|NCT01599325|Secondary|The Number of Platelet Transfusions by Cycle|The number of platelet transfusions received 56 days prior to treatment, considered the baseline period (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for platelets. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.|||Platelet transfusions||Standard Deviation|Mean
2658333|NCT01599325|Secondary|The Number of Units of Platelet Transfusions by Cycle|The number of units of platelet transfusions received 56 days prior to treatment, considered the baseline period, (baseline period defined as the screening period before the date of the first dose of azacitidine; any laboratory and blood transfusion data reported on the day of the first dose of azacitidine was considered to be baseline data) and during study was standardized per 28 days and summarized by cycle for platelets. The formula for standardizing per 28 days was: [(# of transfusions in the measurement period / length of the measurement period (days)) x 28], where the measurement period was either baseline or the relevant cycle length.|Up to cycle 27; The on-treatment period was considered the period from the date of first dose to the last treatment study visit; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.|||Units of platelet transfusions||Standard Deviation|Mean
2658334|NCT01599325|Primary|Percentage of Participants Achieving a Hematologic Improvement (HI) Based on 2000 IWG Response Criteria for MDS and Programmatically Assessed by the Sponsor Using Clinically Relevant Data.|Hematologic improvements (HI) have 4 categories: 1. Erythroid response (HI-E): Major >20g/L increase or transfusion independent. Minor: 10-20g/L increase or ≥50% decrease in transfusion requirements. 2. Platelet response (HI-P): Major absolute increase of ≥30x10^9/L or platelet transfusion independence. Minor: ≥50% increase. 3. Neutrophil response (HI-N): Major 100% increase or an absolute increase of >0.5x10^9/L. Minor: ≥100% increase and absolute increase of <0.5x10^9/L 4. Progression or relapse after HI Hematological improvement (HI) was defined as any type (major or minor) of improvement of HI-E, HI-P, or HI-N. Criteria: Pretreatment=hemoglobin <100g/L or RBC transfusion-dependent, platelet count <100x10^9/L or platelet transfusion dependent, absolute neutrophil count <1.5x10^9/L. Sponsor's determination was derived using clinically relevant data. Denominator for progression/relapse after HI included participants who had achieved HI.|Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.|||percentage of participants||95% Confidence Interval|Number
2658335|NCT01599325|Primary|Percentage of Participants With a Hematologic Response Using IWG Criteria for MDS and Assessed by the Investigator|Hematologic Response is defined by those participants who experienced a Complete Response, Partial Response and Stable Disease (SD) based on IWG 2000 response criteria for MDS. CR = repeat bone marrow (BM) shows <5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (>110 g/L), neutrophils (≥1.5x10^9/L), platelets (≥100x10^9/L), blasts (0%) and no dysplasia • PR = same as CR for peripheral blood: BM shows blasts decrease by ≥ 50% or a less advanced FAB classification from pretreatment • Stable disease (SD): failure to achieve a PR, no evidence of progression for at least 2 months. • Failure: death during treatment or disease progression • Relapse After CR or PR: return to pretreatment BM blast percent or decrement of ≥ 50% from remission/response levels in granulocytes or platelets; or reduction in hgb by ≥20 g/L or transfusion dependence • Disease Progression: change in blast levels • Disease Transformation to Acute Myelogenous Leukemia.|Response initially assessed at end of cycle 6, then every 4 cycles; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.|||percentage of participants||95% Confidence Interval|Number
2658345|NCT01599234|Primary|Change From Baseline in Mean Spasticity 0-10 Numerical Rating Scale (NRS) Score During the Last 14 Day of Treatment (End of Treatment)|"The average spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours where 0 = no spasticity and 10 = worst possible spasticity. A negative value indicates an improvement in pain score from baseline."|0-15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
2659090|NCT01591681|Secondary|Overall Mean Sensor Glucose Overnight|Calculated as the median of the overall mean.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use||||mg/dl|Participants|Inter-Quartile Range|Median
2658336|NCT01599325|Primary|Percentage of Participants With a Hematologic Response Based on the International Working Group (IWG) Criteria for Myelodysplastic Syndrome (MDS) and Programmatically Assessed by the Sponsor Using Clinically Relevant Data.|Hematologic Response is defined by those participants who experienced a Complete Response, Partial Response and Stable Disease (SD) based on IWG 2000 response criteria for MDS. CR = repeat bone marrow (BM) shows <5% myeloblasts, and peripheral blood values lasting ≥ 2 months of hemoglobin (hgb) (>110 g/L), neutrophils (≥1.5x10^9/L), platelets (≥100x10^9/L), blasts (0%) and no dysplasia • PR = same as CR for peripheral blood: BM shows blasts decrease by ≥ 50% or a less advanced FAB classification from pretreatment • Stable disease (SD): failure to achieve a PR, no evidence of progression for at least 2 months. • Failure: death during treatment or disease progression • Relapse After CR or PR: return to pretreatment BM blast percent or decrement of ≥ 50% from remission/response levels in granulocytes or platelets; or reduction in hgb by ≥20 g/L or transfusion dependence • Disease Progression: change in blast levels • Disease Transformation to Acute Myelogenous Leukemia.|Response initially assessed at end of cycle 6, then every 4 cycles; Up to 29 January 2015; 894 days|Intent to Treat (ITT) includes all participants who were enrolled into the study.|||percentage of participants||95% Confidence Interval|Number
2658337|NCT01599234|Secondary|Number of Subjects With a 50% or Greater Improvement in Mean Spasticity 0-10 NRS Score at the End of Treatment Compared to Baseline|"The cumulative response to treatment was the percentage change from baseline in the mean NRS spasticity score as defined as the 50% response. The spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours where 0 = no spasticity and 10 = worst possible spasticity. The number of responders at the 50% level is presented."|0 - 15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis|||participants|||Number
2658338|NCT01599234|Secondary|Change From Baseline in the Mean Total Barthel Activities of Daily Living Index Score at the End of Treatment|The Barthel Index consists of 10 items that measure a person's daily functioning specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. The person receives a score based on whether they have received help while doing the task. The scores for each of the items are summed to create a total score of 100. An increase in score indicates an improvement.|Day 0 (Randomisation) and Day 99 (End of Treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
2658339|NCT01599234|Secondary|Carer Global Impression of Change at the End of Treatment|"The carer of the subject gave their opinion of any noticeable change in the subject's overall functional ability at the end of the study. A 7-point Likert-type scale was used, with the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse. The number of carers who reported an improvement at the end of treatment is presented."|Day 99 (end of treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis, as were a further two subjects who were excluded from the full analysis set as a result of no on-treatment efficacy data|||participants|||Number
2658340|NCT01599234|Secondary|Change From Baseline in Mean Timed 10 Metre Walk Time at the End of Treatment|Only those subjects for whom it was appropriate (i.e. ambulatory subjects) were timed how long it took to walk 10 metres. Walk time was only assessed for subjects who successfully completed the Timed 10 Metre Walk. A negative difference from baseline indicates an improvement walk time.|Day 0 (Randomisation) and Day 99 (End of Treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis|||time (seconds)||Standard Deviation|Mean
2658341|NCT01599234|Secondary|Incidence of Adverse Events as a Measure of Subject Safety|The number of subjects who experienced and adverse event during the course of the study is presented|0-15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis, as were a further two subjects who were excluded from the full analysis set (used for the efficacy analysis) as a result of no on-treatment efficacy data|||participants|||Number
2658342|NCT01599234|Secondary|Change From Baseline in Mean Sleep Quality 0-10 NRS During the Last 14 Days of Treatment (End of Treatment)|"The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked on a scale of '0 to 10', please indicate how your spasticity disrupted your sleep last night? where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline."|0-15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
2658343|NCT01599234|Secondary|Change From Baseline in the Mean Modified Ashworth Scale Score at the End of Treatment|All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition.|Day 0 (Randomisation) and Day 99 (End of Treatment)|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis|||units on a scale||Standard Deviation|Mean
2658344|NCT01599234|Secondary|Number of Subjects With a 30% or Greater Improvement in Mean Spasticity 0-10 NRS Score at the End of Treatment Compared to Baseline|"The cumulative response to treatment was the percentage change from baseline in the mean NRS spasticity score as defined as the 30% response. The spasticity NRS was completed at the same time each day, i.e. bedtime in the evening. The subject was asked on a scale of '0 to 10', please indicate the number that best describes your spasticity in the last 24 hours where 0 = no spasticity and 10 = worst possible spasticity. The number of responders at the 30% level is presented."|0-15 weeks|All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis|||participants|||Number
2658347|NCT01599104|Secondary|Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure|Ambulatory pulse pressure was calculated as hourly ambulatory SBP minus hourly ambulatory DBP in a subset of participants.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.|||mmHg||Standard Error|Least Squares Mean
2658348|NCT01599104|Secondary|Change From Baseline in Office Pulse Pressure|Office pulse pressure was calculated as msSBP minus msDBP. Sitting blood pressure (BP) measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and then averaged to calculate the mean BP value. The baseline PP value was subtracted from the week 8 PP value to determine the change from baseline in PP.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.|||mmHg||Standard Error|Least Squares Mean
2658349|NCT01599104|Secondary|Change From Baseline in maSBP and maDBP for Daytime/Nighttime|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.|||mmHg||Standard Error|Least Squares Mean
2658350|NCT01599104|Secondary|Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8|ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.|||mmHg||Standard Error|Least Squares Mean
2658351|NCT01599104|Secondary|Percentage of Participants Achieving a Successful msDBP Response|Successfull msDBP response was defined as <90 mmHg or ≥10 mmHg reduction from baseline.|8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.|||Percentage of participants|||Number
2658352|NCT01599104|Secondary|Percentage of Participants Achieving a Successful msSBP Response|Successful msSBP response was defined as < 140 mmHg or ≥ 20 mmHg reduction from baseline.|8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.|||Percentage of participants|||Number
2658353|NCT01599104|Secondary|Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8|A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.|8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.|||Percentage of participants|||Number
2658354|NCT01599104|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting BP measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline BP measurements.|||mmHg||Standard Error|Least Squares Mean
2658355|NCT01599104|Secondary|Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8|Ambulatory blood pressure monitoring (ABPM) over a 24-hour period was conducted at two time-points during the study in a subset of participants.|Baseline, 8 weeks|The full analysis set included all randomized participants who received study medication, and had both baseline and post-baseline ABPM measurements. This outcome measure was analyzed in a subset of participants within each treatment group where n = 216 for the LCZ 200 mg group, n = 216 for the LCZ 400 mg group and n = 200 for the Olmesartan group.|||mmHg||Standard Error|Least Squares Mean
2658356|NCT01599104|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)|Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.|Baseline, 8 weeks|Full Analysis Set (FAS): The full analysis set included all randomized participants who received study medication and had both baseline and post-baseline BP assessments.|||mmHg||Standard Error|Least Squares Mean
2658357|NCT01598987|Secondary|Growth Development - Height at Baseline and Month 24|"Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.~Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile)."|Baseline, Month 24|Safety Analysis Set|||Percentages|||Number
2658358|NCT01598987|Secondary|Growth Development - Weight at Baseline and Month 24|"Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.~Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile)."|Baseline, Month 24|Safety Analysis Set|||Percentages|||Number
2658408|NCT01598311|Primary|Percentage of Participants Experiencing an Adverse Event (AE)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.|Up to 30 days after EOT (up to Day 40)|The analysis population consists of all randomized and treated participants (Safety Population).|||Percentage of Participants|||Number
2658359|NCT01598987|Secondary|Growth Development - Weight at Baseline and Month 12|"Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.~Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile)."|Baseline, Month 12|Safety Analysis Set|||Percentages|||Number
2658360|NCT01598987|Secondary|Growth Development - Height at Baseline and Month 12|"Individual growth measurements were compared with the gender and age-specific growth percentiles in the CDC growth charts for the US population. Each value observed is thus represented by the (approximated) percentage of subjects with a lower value in the reference population. Changes were calculated on this scale and thus express the change in growth measurements relative to the percentiles in the CDC growth charts.~Patients were classified into growth percentile categories (<=5, >5-25, >25-50, >50-75, >75-95 and >95% percentile)."|Baseline, Month 12|Safety Analysis Set|||Percentages|||Number
2658361|NCT01598987|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate - Month 24|Evolution of renal function assessed by estimated Glomerular Filtration Rate (eGFR) calculated by the Chronic Kidney Disease in Children (CKiD) Schwartz formula (Schwartz 2009), expressed in mean change in eGFR of CKiD between start of study (baseline assessment) and Month 24.|Baseline, Month 24|Full analysis set|||mL/min/1.73m2||Standard Deviation|Mean
2658362|NCT01598987|Secondary|Kaplan-Meier Estimates for Failure Rates of Efficacy Endpoints|"The proportion of patients with composite efficacy failure (treated biopsy proven acute rejection[tBPAR], graft loss [GL] , death [D]) before/at Month 12 and Month 24, estimated with Kaplan-Meier (KM) methods and the proportion of patients who experienced any of the components of composite efficacy failure (tBPAR, GL, D) before/at Month 12 and Month 24, separately for each component.~AR: acute rejection; BPAR: biopsy proven acute rejection. Rate = Kaplan-Meier estimate for failure in %; CI = confidence interval for failure rate."|At 12-month and 24-month after start of study drug|Full Analysis Set|||Percentages||80% Confidence Interval|Number
2658363|NCT01598987|Primary|Change From Baseline in Estimated Glomerular Filtration Rate - Month 12|Evolution of renal function assessed by estimated Glomerular Filtration Rate (eGFR) calculated by the Chronic Kidney Disease in Children (CKiD) Schwartz formula (Schwartz 2009), expressed in mean change in eGFR of CKiD between start of study (baseline assessment) and Month 12.|Baseline, Month 12|Full Analysis Set|||mL/min/1.73m^2||Standard Deviation|Mean
2658364|NCT01598896|Secondary|Change in Craving Symptoms From Baseline at 14 Weeks|"Scores on the Marijuana Craving Questionnaire (Heishman et al. 2009) - The 4 Factor Total Score~Maximum Score = 84 Minimum Score = 12 The higher the score, the more severe marijuana craving symptoms endorsed by the subject."|At 14 weeks|Only 1 placebo subject completed Week 14 of the study and had Week 14 MCQ Total Score data.|||score on MCQ Total 4 Factor scale||Standard Deviation|Mean
2658365|NCT01598896|Secondary|Change From Baseline in Cannabis Use at 14 Weeks|Self-report cannabis use at 14 weeks after initiating the study.|At 14 weeks|Only 1 of the placebo subjects had week 14 data due to the other week 10 completer not attending the follow-up visit at week 14.|||hits/day||Standard Deviation|Mean
2658366|NCT01598896|Secondary|Change in Craving Symptoms From Baseline at 10 Weeks|"Scores on the Marijuana Craving Questionnaire (MCQ) (Heishman et al. 2009) - The 4 Factor Total Score.~Maximum Score = 84 Minimum Score = 12 The higher the score, the more severe marijuana craving symptoms endorsed by the subject."|At 10 weeks|Only 2 of the placebo subjects completed week 10 and had MCQ scores for Week 10.|||score on a MCQ 4 Factor Total scale||Standard Deviation|Mean
2658367|NCT01598896|Primary|Change From Baseline in Cannabis Use at 10 Weeks|Subject self-report hits of marijuana per day at week 10|At 10 weeks|Only 2 of the 4 placebo subjects had Week 10 data due to dropping out of the study.|||hits/day||Standard Deviation|Mean
2658368|NCT01598831|Post-Hoc|Day 28 Mortality in Subjects With INR > 1.4 at Baseline and PLT > 30K at Baseline|Post-Hoc analysis of Day 28 Mortality in Subjects with INR > 1.4 at Baseline and PLT > 30K at Baseline|Day 28|Full Analysis Set - All randomized and dosed subjects.|||Participants|||Count of Participants
2658369|NCT01598831|Secondary|Number of Participants With Anti-drug Antibodies|Presence of Anti-drug antibodies up to 18 months|18 months|Safety population: all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group)|||Participants|||Count of Participants
2658370|NCT01598831|Secondary|Number of Event Free and Alive Days to Measure Resolution of Organ Dysfunction|Resolution of organ dysfunction as measured through day 28 by shock free, ventilator free, dialysis free plus alive days.|28 days|Full Analysis Set - All randomized and dosed subjects.|||Days||Standard Deviation|Mean
2658371|NCT01598831|Secondary|Follow up All-cause Mortality at 3 Months|Follow up all-cause mortality at 3 months|3 months|Full Analysis Set - All randomized and dosed subjects.|||Participants|||Count of Participants
2658372|NCT01598831|Primary|Number of Participants With On-Treatment Serious Major Bleeding Events|On-treatment Serious Major Bleeding Events collected as Serious Adverse Events and defined as: any intracranial hemorrhage, any life-threatening bleeding, any bleeding event classified as serious by the Investigator (e.g., resulting in permanent morbidity), or any bleeding that required the administration of 1440 ml (typically 6 units) of packed red cells over two consecutive days. (Investigator assessment for seriousness criteria.)|Through Study Day 28|Safety population: all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group)|||Participants|||Count of Participants
2658373|NCT01598831|Primary|Number of Participants With 28-Day All-cause Mortality|28-Day All-cause Mortality|28 days|Full Analysis Set - All randomized and dosed subjects.|||Participants|||Count of Participants
2658374|NCT01598779|Primary|Human Papillomavirus (HPV) Types in External Genital Warts (EGW)|150 biopsies with histological diagnosis of genital warts were analyzed by PCR to detect HPV type|4 months|Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, All biopsies were analyzed to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.|||percentage of participants|||Number
2658375|NCT01598753|Primary|Number of Participants With a 30% Improvement in Pain or 20% Improvement in Function|"The primary outcome is a reduction of at least 30% on the pain score (mean for 5-day daily pain diary) or improvement of 20% physical function (FIQR) from baseline (pre-treatment) to post-treatment. Individuals who achieve such decrease in pain or increase in function are labeled responders."|Baseline (one week prior to drug titration) to post-treatment (approximately 11 weeks after baseline).||||Participants|||Count of Participants
2658376|NCT01598740|Secondary|Change in Fecal Weight|Change = (Days 10-13/29-32 Daily Average) - (Days 3-6/22-25 Daily Average)|baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32)||||grams||Standard Deviation|Mean
2658377|NCT01598740|Primary|Change in Fecal Sodium Content|Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average)|baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32)||||mg||Standard Deviation|Mean
2658378|NCT01598701|Secondary|Time for Patient to Meet Post-anesthesia Care Unit (PACU) Discharge Criteria||From time of entry to PACU to time to meet PACU discharge criteria, an average of 12 minutes|The number analyzed is greater than the number completed because this data was collected for more patients than completed the study, and all data that was collected is reported here.|||minutes||Standard Deviation|Mean
2658379|NCT01598701|Secondary|Time to Extubation at Emergence From Anesthesia||Time from of discontinuation of anesthetic to time of extubation, an average of 7 minutes|The number analyzed is greater than the number completed because this data was collected for more patients than completed the study, and all data that was collected is reported here.|||minutes||Inter-Quartile Range|Median
2658380|NCT01598701|Secondary|Post-Operative Side Effects|Patients will be monitored for 24 hours post-operatively to detect the incidence of any drug or opioid-related side effects. These side effects were not considered to be adverse events.|24 Hours Post-Operatively|The # analyzed does not match the # who completed or the overall # analyzed because data on all side effects was not collected for all participants who completed, either due to lack of collection of data by research/nursing staff (for emesis) or due to lack of reporting by participants on a questionnaire(for itching, dizziness, and drowsiness).|||Participants|||Count of Participants
2658381|NCT01598701|Secondary|Post-Operative Pain|Patients will be assessed for pain using a Visual Analogue Scale (VAS) Scale at set time points after surgery (0,1,2,4,8,12,16,20,24 hours post-operatively). The Visual Analogue Scale (VAS) scale was measured on a scale of 0 - 10 (0 = no pain, 1-3 = mild, 4-6 = moderate, 7-10 = severe). Higher values on the VAS represent a worse outcome. The two rows below report: 1. the average VAS score for the least amount of pain reported per group and 2. the average VAS score of the worst amount of pain reported per group.|24 Hours Post-Operatively||||units on a scale||Standard Deviation|Mean
2658382|NCT01598701|Primary|Post-Operative Opioid Requirement|Opioid Consumption will be monitored in the first 24 post-operative hours. All non-opioid analgesics are disallowed. Total opioid consumption was calculated based on morphine equivalents (MEs), where 1 mg of IV morphine was equivalent to 1 ME, and 1 mg IV hydromorphone was calculated as 7 MEs.|24 hours post-operatively||||Morphine Equivalents||Inter-Quartile Range|Median
2658383|NCT01598662|Primary|IUD Expulsion Rate|The investigators wanted to compare the expulsion rate of IUDs between the two treatment arms: immediate placement after placental delivery and interval placement 6 weeks after delivery. IUD expulsion is confirmed by the inability of the physician to visualize the string attached to the IUD coming from the cervix.|6 months|"0 participants were evaluable in the Arm IUD Insertion 6 Weeks After Delivery, as 0 participants received an IUD at 6 weeks, and 2 participants in the Arm Immediate Post-placental Insertion were evaluable, as there were only 2 participants that came back for a follow up appointment."|||Participants|||Count of Participants
2658384|NCT01598610|Secondary|Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements|Subjects respond to statements read by study staff to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'.|1 hour|Per protocol|||participants|||Number
2658385|NCT01598610|Secondary|Percent of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method When Tested by Study Staff|Study staff test subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results.|1 hour|217 (220-3) blood test results were analyzed. Blood data for 2 subjects were not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick results were obtained for 1 subject.|||percentage of BG Test Results|||Number
2658386|NCT01598610|Secondary|Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 5to15mg/dL (<100mg/dL YSI capillary plasma) or +/- 5to15% (>=100mg/dL YSI capillary plasma) of the reference method results.|1 hour|108 (110-2) blood test results from one test strip lot were analyzed. Blood data for 1 subject was not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick result was obtained for 1 subject.|||percentage of BG Test Results|||Number
2658387|NCT01598610|Secondary|Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. Venous plasma BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI venous plasma) or +/- 20% (>=75mg/dL YSI venous plasma) of the reference method results.|1 hour|213 (220-7) blood test results were analyzed. Venipuncture was unsuccessful for 6 subjects. Blood data for 1 subject was not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method.|||percentage of BG Test Results|||Number
2658388|NCT01598610|Secondary|Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results.|1 hour|213 (220-7) blood test results were analyzed. Four(4) subjects had low blood sugar and AST results were not evaluable per protocol. One(1) subject with low blood sugar (AE) did not attempt AST testing per protocol. No AST palm results were obtained for 2 subjects.|||percentage of BG Test Results|||Number
2658389|NCT01598610|Primary|Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) of the reference method results.|1 hour|216 (220-4) blood test results were analyzed. Blood data for 2 subjects were not evaluable because time, defined in protocol, was exceeded between meter test and blood sample preparation for reference method. No fingerstick results were obtained for 2 subjects.|||percentage of BG Test Results|||Number
2658390|NCT01598545|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|24 hours after intrathecal injection||||units on a scale||Full Range|Mean
2658391|NCT01598545|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|18 hours after intrathecal injection||||units on a scale||Full Range|Mean
2658392|NCT01598545|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|6 hours after intrathecal injection||||units on a scale||Full Range|Mean
2658393|NCT01598545|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|Baseline||||units on a scale||Full Range|Mean
2658394|NCT01598545|Primary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|12 hours after intrathecal injection||||units on a scale||Full Range|Mean
2658395|NCT01598532|Primary|Digit Span, Forwards and Backwards|Digit Span, Forwards and Backwards measures short-term auditory memory and working memory that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment|All participants enrolled in the Transcranial LED Treatment Group|||# of SD units||Standard Deviation|Mean
2658396|NCT01598532|Primary|Controlled Oral Word Association Test (FAS)|Controlled Oral Word Association Test (FAS) measures verbal fluency that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment|All participants enrolled in the Transcranial LED Treatment Group|||# of SD units||Standard Deviation|Mean
2658397|NCT01598532|Primary|California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall|California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall measures word recall after a 20 minute delay that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment|All participants enrolled in Transcranial LED Treatment Group|||# of SD Units||Standard Deviation|Mean
2658398|NCT01598532|Primary|California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5|California Verbal Learning Test-II (CVLT-II) Total, Trials 1 - 5 measures word recall on trials 1-5 that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after Final LED Treatment|All participants enrolled in Real Intervention Group|||# of SD Units||Standard Deviation|Mean
2658399|NCT01598532|Primary|Stroop Test for Executive Function - Trial 4 Inhibition Switching|Stroop Test for Executive Function - Trial 4 (D-KEFS) Inhibition Switching that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-Month and 2-Months after the Final LED Treatment|All participants enrolled in Transcranial LED Treatment Group|||# of SD Units||Standard Deviation|Mean
2658400|NCT01598532|Primary|Stroop Test for Executive Function - Trial 3 - Inhibition|Stroop Test for Executive Function - Trial 3 (D-KEFS) - Inhibition measures executive function, inhibition that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.|Baseline and 1-Week, 1-month and 2-months after final LED Treatment|All participants enrolled in the Transcranial LED Treatment Group|||# of SD units||Standard Deviation|Mean
2658401|NCT01598506|Secondary|Pain Scores, Visual Analogue Pain Scale|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|Baseline||||units on a scale||Full Range|Mean
2658402|NCT01598506|Primary|Pain Score, Visual Analogue Pain Scores|Continuous Visual Analogue Scale 0 - 10 (0=no pain, 10=worst imaginable pain).|30 minutes after intrathecal injection||||units on a scale||Full Range|Mean
2658403|NCT01598428|Secondary|Refractive Error|auto refraction was performed at each visit. Spherical equivalent refraction (SER) (sphere +cylinder/2) was used in subsequent calculations.|1 day，1 week, 1 month as well as 3 months and 6 months postoperatively||||diopter(D)|Participants|Standard Deviation|Mean
2658404|NCT01598428|Secondary|Uncorrected Visual Acuity(UCVA)|The UCVA was recorded in logMAR units at each vist|1 day，1 week, 1 month as well as 3 months and 6 months postoperatively||||logMAR|Participants|Standard Deviation|Mean
2658405|NCT01598428|Primary|Effective Lens Position|Effective lens position was measured with anterior chamber depth 1 day，1 week, 1 month as well as 3 months and 6 months postoperatively using anterior segment Optical Coherence Tomograph. The anterior chamber depth defined as the distance between the posterior surface of the corneal and anterior surface of intraocular lens in the pupil center along the optical axis. The actual movement of intraocular lenses was defined as the root mean square of changes in the effective lens position at each visit.|1 day，1 week, 1 month，3 months and 6 months postoperatively||||mm|Participants|Standard Deviation|Mean
2658406|NCT01598350|Primary|Step Width||60 minutes||||cm||Standard Deviation|Mean
2658409|NCT01598311|Secondary|Adjusted Percentage of Participants With Sustained Clinical Response at End of Study|The percentage of participants with sustained clinical response was determined for each arm. Sustained clinical response was declared when participants had a clinical outcome of cure at EOT, did not experience any CDAD recurrence, did not die, were not lost to follow-up, and did not have the end of study visit prior to Day 40. Percentages were first stratified according to age (<75 or ≥75 years) and number of previous CDAD episodes (0 or ≥1) and constructed using Mehrotra-Railkar continuity-corrected minimum-risk stratum weights, and the weighted averages were then derived across strata in order to calculate the adjusted percentage.|Up to 40 days after EOT (up to Day 50)|The analysis population consists of all randomized and treated participants with a confirmed CDAD diagnosis (mMITT population).|||Adjusted percentage of participants||95% Confidence Interval|Number
2658410|NCT01598311|Secondary|Number of Clinical Failure Events up to Day 40|The total number of clinical failure events, which included treatment failure, CDAD recurrence, death, or being lost to follow-up, occurring during each time period was determined in each arm.|Up to 30 days after EOT (up to Day 40)|The analysis population consists of all randomized and treated participants with a confirmed CDAD diagnosis (mMITT population).|||Number of Failure Events|||Number
2658411|NCT01598311|Primary|Adjusted Percentage of Participants Meeting Clinical Response Criteria for Cure at End of Treatment (EOT)|"The percentage of participants considered cured (i.e., ≤2 loose stools per 24 hour period for at least 2 consecutive days and no need for additional antibiotics during the 3 days following EOT) was determined in the mMITT population. A CDAD diagnosis was defined as: 1) diarrhea with a minimum of 3 unformed bowel movements (UBM) or >200 mL volume of stool for participants with a collection device (e.g., rectal tube or colostomy bag) over 24 hours; and 2) a positive result for Clostridium difficile toxin by enzyme immunoassay (EIA), polymerase chain reaction (PCR), or a cell culture cytotoxin neutralization assay. Percentages were first stratified according to age (<75 or ≥75 years) and number of previous CDAD episodes (0 or ≥1) and constructed using Mehrotra-Railkar continuity-corrected minimum-risk stratum weights, and the weighted averages were then derived across strata in order to calculate the adjusted percentage."|Up to 3 days after EOT (up to Day 13)|The analysis population consists of all randomized and treated participants with a confirmed CDAD diagnosis (mMITT population).|||Adjusted percentage of participants||95% Confidence Interval|Number
2658412|NCT01598298|Secondary|Pain Interference According to the BPI-SF|"Pain interference according to the BPI-SF: this item has a scale of 0 to 10 with 0 indicating Does not interfere and 10 indicating Completely interferes."|Weeks 2, 6, 12, and 24; Week 12 reported|Patients evaluable for primary endpoint|||units on a scale||Standard Deviation|Mean
2658413|NCT01598298|Secondary|Worst Joint Pain According to the BPI-SF|"Worst joint pain according to the BPI-SF worst pain score (item #2). This item has a scale of 0 to 10 with 0 indicating No pain and 10 indicating Pain as bad as you can imagine."|Weeks 2, 6, 12, and 24; Week 12 reported|Patients evaluable for primary endpoint|||units on a scale||Standard Deviation|Mean
2658414|NCT01598298|Primary|Average Joint Pain According to BPI-SF|"Average joint pain according to the Brief Pain Inventory - Short Form (BPI-SF) average pain score (item #4). This item has a scale of 0 to 10 with 0 indicating No pain and 10 indicating Pain as bad as you can imagine."|Weeks 2, 6, 12, and 24; Week 12 reported|Patients evaluable for primary endpoint|||units on a scale||Standard Deviation|Mean
2658415|NCT01598207|Secondary|Sensory Thresholds for Pain|When highest amount of pain was felt; range is 0-65 mmHg|Baseline and 1 month|1 participant in marinol and 1 participant in placebo did not have this information completed|||mmHg||Standard Deviation|Mean
2658416|NCT01598207|Secondary|Sensory Thresholds for Discomfort|When participants felt pain at earliest pressure; range 0-65 mmHg|Baseline and 1 month|1 participant in marinol and 1 participant in placebo did not have this information completed|||mmHg||Standard Deviation|Mean
2658417|NCT01598207|Secondary|Duration of Chest Pain Episodes|0 - is none and 3 is longer than 30 mins; higher values is worst outcome; chest pain totals are averaged|Baseline vs 1 month|1 participant in placebo did not have this information completed|||units on a scale||Standard Deviation|Mean
2658418|NCT01598207|Secondary|Sensory Thresholds for First Sensation|This is determined by the Esophageal Balloon Distension Test; range 0-65 mmHg|Baseline and 1 month||||mmHg||Standard Deviation|Mean
2658419|NCT01598207|Secondary|Intensity of Chest Pain Episodes|Intensity (0(none) - 3(severe)) at baseline vs 1 month for chest pain episodes; higher represents worse outcome; multiple chest pain totals are averaged|Baseline and 1 month|1 participant in placebo did not have this information completed|||units on a scale||Standard Deviation|Mean
2658420|NCT01598207|Secondary|Frequency of Chest Pain in Treatment Group vs Baseline|Total (intensity (0(none) - 3(severe) + duration (0(none) - 3(longer than 30 mins)) at end of 1 month treatment; higher represents worse outcome; the total score ranges from 0 to 6 and is the sum of the intensity and duration|1 month|1 participant in placebo did not have this information completed|||units on a scale||Standard Deviation|Mean
2658421|NCT01598207|Primary|Frequency of Chest Pain Episodes|Number of people still experiencing the same amount of chest pain during treatment than previously without|Baseline and 1 month||||participants|||Number
2658422|NCT01598194|Secondary|Comparison of Diagnostic Adequacy of Single Pass With 22G Core Needle and Standard 25G Needle for Cytologic Diagnosis|The cytologic diagnostic adequacy of 22Gpc was compared to the standard 25G needle. Diagnostic adequacy was defined as the ability to procure cytological aspirates that were sufficient for diagnostic interpretation. Two cytopathologists, blinded to needle type and technique, reviewed and graded all the study slides. Cytologic diagnostic adequacy of each pass was graded on a semiquantitative scale from 0 to 3 based on sample cellularity. A score of 2 (estimated cell count > 500 cells) or 3 (estimated cell count > 1000 cells) was considered adequate for diagnosis; a score of 3 was most desirable. A score < 2 was considered inadequate.|Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes||||Participants|||Count of Participants
2658449|NCT01597908|Secondary|Overall Response, as Assessed by the Investigator|Overall response is defined as the number of responders (complete response [CR] + partial response [PR] per RECIST, Version 1.1) as summarized by Investigator assessment. CR is defined as the disappearance of all evidence of target lesions. PR is defined as at least a 30% reduction from Baseline in the sum of the longest diameter (LD) of all target lesions. Data are reported as those participants with measureable disease.|Screening, Week 8 and every 8 weeks thereafter through Week 56, and then every 12 weeks|ITT Population|||Participants|||Number
2658423|NCT01598194|Primary|Comparison of Diagnostic Adequacy Scores With SST vs. CST for Histologic Diagnosis Using a 22G Core Needle.|The main outcome measure of the study was the diagnostic adequacy of the 22Gpc using SST versus CST on EUS-FNA. The cytologic diagnostic adequacy of 22Gpc was also compared to the standard 25G needle. Diagnostic adequacy was defined as the ability to procure cytological aspirates or histological core tissue samples that were sufficient for diagnostic interpretation. Two cytopathologists, blinded to needle type and technique, reviewed and graded all the study slides. Cytologic diagnostic adequacy of each pass was graded on a semiquantitative scale from 0 to 3 based on sample cellularity. A score of 2 (estimated cell count > 500 cells) or 3 (estimated cell count > 1000 cells) was considered adequate for diagnosis; a score of 3 was most desirable. A score < 2 was considered inadequate. Histologic diagnostic adequacy was graded as either an adequate (score 2 or 3) or inadequate specimen for diagnosis.|Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes||||Participants|||Count of Participants
2658424|NCT01598194|Primary|Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle.|The main outcome measure of the study was the diagnostic adequacy of the 22Gpc using SST and CST. The cytologic diagnostic adequacy of 22Gpc was also compared to the standard 25 G needle. Each participant underwent 4 study passes, 2 passes with a standard 25 G needle using SST, plus a random assignment to one of two groups for 2 passes with the 22Gpc (1 pass for cytologic and 1 pass for histologic analysis) using SST (group 1) or CST (group 2). Diagnostic adequacy was defined as the ability to procure cytological aspirates or histological core tissue samples that were sufficient for diagnostic interpretation.|Each EGD EUS-FNA endoscopy procedure takes about 1 hour. Each needle pass takes about 1-2 minutes.||||Participants|||Count of Participants
2658425|NCT01598129|Primary|Recommended Phase 2 Dose by Identification of Any Dose Limiting Toxicities|No Dose Limiting Toxicities were observed at any dose level.|6 months||||Dose limiting toxicities|||Number
2658426|NCT01598129|Other Pre-specified|Number of Patients With Induction of Tumor-specific CD8+ T Cells in Peripheral Blood Monomuclear Cells.||6 months||||participants|||Number
2658427|NCT01598129|Other Pre-specified|Number of Participants With Infiltration of CD8+ T Cells Into Tumors.||6 months||||participants|||Number
2658428|NCT01598129|Other Pre-specified|An Immune Response to Treatment Was Assessed by Measuring a Temporary Increase in Pro-inflammatory Cytokines After Treatment Was Administrered.||6 hours||||participants|||Number
2658429|NCT01598129|Other Pre-specified|Quality of Life Using EORTC QLQ-C30.|To assess the feasibility and usefulness of EORTC QLQ-C30 for possible use in later studies.|12 months|||||||
2658430|NCT01598129|Other Pre-specified|Number of Participants With Stable Disease Status as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Evaluation Three Months After Starting CGTG-102 Treatment.||3 months||||participants|||Number
2658431|NCT01598129|Secondary|To Determine the Safety, Tolerability and Adverse Event Profile of CGTG-102 With Low-dose CPO. To Obtain Preliminary Evidence of Antitumour Activity.|Clinical and laboratory assessment. Response rate, disease control rate, progression free and overall survival.|12 months|||||||
2658432|NCT01598129|Primary|Number of Participants With Any (Serious and Non-Serious) Adverse Event Measured to Assess Safety and Tolerability.||6 months||||participants|||Number
2658433|NCT01598090|Secondary|Percentage of Participants With Rash|All skin reactions involving rash or rash-like events that occurred on treatment were reported.|After Day 1 of treatment up to Week 48|The analysis was performed in all treated participants.|||Percentage of participants|||Number
2658434|NCT01598090|Secondary|Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B|SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL).|Follow-up Week 24|Analysis was performed using Observed value method, defined as proportions of participants meeting response criteria in numerator and denominator - all treated participants with HCV RNA measured at follow-up Week 24. Analysis was performed in all treated participants with HCV RNA measured at follow-up Week 24 due to early study termination.|||Percentage of participants||95% Confidence Interval|Number
2658435|NCT01598090|Secondary|Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B|Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain.|After Day 1 of treatment up to Week 48|The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.|||Percentage of participants||95% Confidence Interval|Number
2658436|NCT01598090|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B|eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).|Week 4 and Week 12|The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.|||Percentage of participants||95% Confidence Interval|Number
2658437|NCT01598090|Secondary|Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B|Cytopenic abnormalities included anemia defined as hemoglobin <10 grams/decilitre; neutropenia defined as Absolute neutrophil count (ANC) <750 cubic millimetre (mm^3); thrombocytopenia defined as platelets <50,000 mm^3.|After Day 1 of treatment up to Week 48|The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.|||Percentage of participants||95% Confidence Interval|Number
2658473|NCT01597687|Secondary|Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Taiwan|The travel costs were assessed in the local currency of each country, as follows: Taiwan - New Taiwan dollar (NTD)|At time of questionnaire administration (Day 0)|The assessment was performed only on the Taiwanese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.|||New Taiwan dollar (NTD)||Standard Deviation|Mean
2658438|NCT01598090|Secondary|Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B|SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).|Follow-up Week 12|The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treatment-naive treated participants.|||Percentage of participants||95% Confidence Interval|Number
2658439|NCT01598090|Secondary|Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A|SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.|Follow up week 24|Analysis was performed using Observed value method, defined as proportions of participants meeting response criteria in numerator and denominator - all treated participants with HCV RNA measured at follow-up Week 24. Analysis was performed in all treated participants with HCV RNA measured at follow-up Week 24 due to early study termination.|||Percentage of participants||95% Confidence Interval|Number
2658440|NCT01598090|Secondary|Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A|SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ =25 IU/mL; limit of detection ~ 10 IU/mL).|Follow-up Week 12|The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.|||Percentage of participants||95% Confidence Interval|Number
2658441|NCT01598090|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A|An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal product. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or caused prolongation of existing hospitalization.|Day 1 of treatment up to Week 48|Safety analysis included all treated participants.|||Participants|||Count of Participants
2658442|NCT01598090|Primary|Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B|SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).|Follow-up Week 12|The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.|||Percentage of participants||95% Confidence Interval|Number
2658443|NCT01598090|Primary|Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A|eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).|Assessed at Week 4 and Week 12, week 12 reported|The analysis was performed using Modified Intent-to-Treat method, defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.|||Percentage of participants||95% Confidence Interval|Number
2658444|NCT01598064|Secondary|Liver Function Evaluation|Measure ALT level of patients|8 weeks||||U/L||Standard Deviation|Mean
2658445|NCT01598064|Primary|Admission Due to Complications Related to Portal Hypertension||8 weeks||||participants|||Number
2658446|NCT01598025|Secondary|Evaluation of Recipients Post Transplant|The levels of engraftment and persistence of hematopoietic cells and their myeloid and lymphoid progressing from each donor post transplant. The tolerance or reactivity of engrafted T cells from each donor detected in the blood at 3, 6, and thereafter every 3-6 months until normal, post transplant against host cells and cells derived from the other parent as measured by standard mixed lymphocyte culture and cell mediated cytolysis assays.|1 year|Due to the small accrual on study, as well as patient course following treatment on study, the primary objectives of this study were not able to be analyzed.||||||
2658447|NCT01598025|Primary|Efficacy of HLA-haploidentical Biparental T-cell Depleted CD34+ Peripheral Blood Stem Cell Transplants|"Efficacy is measured by:~incidence of transplant-related mortality, overall survival and disease-free survival at 1 year post transplant.~incidence, tempo and complications of engraftment and hematopoietic reconstitutions and conversely, the risk of graft failure~incidence and severity of acute and/or chronic GVHD~incidence and severity of opportunistic infections developing following engraftment"|1 year|Due to the small accrual on study, as well as patient course following treatment on study, the primary objectives of this study were not able to be analyzed.||||||
2658448|NCT01597908|Secondary|Duration of Response, as Assessed by the Investigator|Duration of response is defined as the time from the first documented evidence of a CR (disappearance of all evidence of target lesions) or a PR (at least a 30% reduction from Baseline in the sum of the longest diameter of all target lesions) until disease progression or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 mm or the appearance of at least1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Data are summarized per RECIST, Version 1.1.|From the first documented evidence of a CR or PR until the earliest date of disease progression or death due to any cause (up to Study Week 80)|ITT Population. Only those participants with a confirmed response (CR and PR) were analyzed. Participants with measurable and non-measurable disease were analyzed.|||Months||95% Confidence Interval|Median
2658450|NCT01597908|Secondary|Progression-free Survival, as Assessed by the Investigator|Progression-free survival (PFS) is defined as the time from randomization to the first documented occurrence of disease progression or death due to any cause. PFS for investigator-assessed response was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|From randomization to the first documented occurrence of disease progression or death due to any cause (up to Study Week 80)|ITT Population. Participants who did not progress or die or who progressed or died after the start of new anti-cancer therapy or after an extended period without adequate assessment were censored at their date of last adequate assessment prior to progression or death even if subsequent information was available regarding progression or death.|||Months||95% Confidence Interval|Median
2658451|NCT01597908|Primary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|From randomization until death due to any cause (up to Study Week 92)|Intent-to-Treat (ITT) Population: all randomized participants, whether or not study medication was administered. All participants in the ITT Population were analyzed. For participants who did not die, time of death was censored at the date of last contact.|||Months||95% Confidence Interval|Median
2658452|NCT01597856|Secondary|Mean PTSD Severity Score|Measure on Clinical Assessment of PTSD Severity (CAPS IV) rating scale (range 0-136, higher is more severe symptoms).|12 weeks||||score on a scale||Standard Deviation|Mean
2658453|NCT01597856|Secondary|Substance Use by Treatment Group Over Time|Mean days self-reported risky drug or alcohol use|4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks||||days||Standard Deviation|Mean
2658454|NCT01597856|Primary|Treatment Attendance by Treatment Group Over Time|Mean number of weeks of substance abuse and/or mental health treatment attended (as measured by the Electronic Medical Record) by treatment group over time|4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks||||weeks||Standard Deviation|Mean
2658455|NCT01597843|Primary|Registration for MHV|Measured by response to question: Have you ever used My HealtheVet online?|Baseline; After Group 1 Intervention; After Group 2 Intervention|Respondents to first round survey|||Percentage of respondents who use MHV|||Number
2658456|NCT01597791|Primary|Number of Participants With Positive Urine Culture|This study will be assessed by collecting a twenty-four to forty-eight hour midstream urine sample and performing a urine culture. The clinical and laboratory criteria used to define a urinary tract infection.|48 Hours||||participants with positive urine culture|||Number
2658457|NCT01597687|Secondary|Assessment of the Impact of Pertussis on Quality of Life of Patients: Average EQ-5D Index Score|Health-related quality of life of pertussis patients was assessed using the EQ-5D Questionnaire. The EQ-5D is composed of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), with 3 levels of severity within each dimension. Average of EQ-5D index score (ranging from 0 to 1; 0 being death and 1 being in perfect health) across sero-confirmed participants was reported.|At time of questionnaire administration (Day 0)|The assessment was performed only on the subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.|||Scores on a scale||Standard Deviation|Mean
2658458|NCT01597687|Secondary|Assessment of the Impact of Pertussis on Quality of Life of Patients: Number of Participants Reporting Problems With Specific Characteristics|"Health-related quality of life of pertussis patients was assessed using the EQ-5D Questionnaire. The EQ-5D is composed of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), with 3 levels of severity within each dimension. The EQ-5D levels were further dichotomised into no problems (level 1) and with problems (level 2 & 3). The number of participants within these 2 levels are reported."|At time of questionnaire administration (Day 0)|The assessment was performed only on the subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.|||Participants|||Count of Participants
2658459|NCT01597687|Secondary|Assessment of Health Economical Impact - Summary of Total Amount of Time Spent by Sero-confirmed Subjects Visiting Healthcare Resources in General|Total amount of time spent on seeing the doctor(s) which includes the return trip and the overall time spent at clinic(s)/hospital(s) for waiting, consultation, tests, pharmacy etc.|At time of questionnaire administration (Day 0)|The assessment was performed only on the subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.|||Hours||Standard Deviation|Mean
2658460|NCT01597687|Secondary|Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Thailand|The medical costs were assessed in the local currency of each country, as follows: Thailand - Thai baht (BAHT). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the healthcare resources in general|At time of questionnaire administration (Day 0)|The assessment was performed only on the Thailandese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.|||Thai baht (BAHT)||Standard Deviation|Mean
2658461|NCT01597687|Secondary|Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Taiwan|The medical costs were assessed in the local currency of each country, as follows: Taiwan - New Taiwan dollar (NTD). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the healthcare resources in general|At time of questionnaire administration (Day 0)|The assessment was performed only on the Taiwanese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.|||New Taiwan dollar (NTD)||Standard Deviation|Mean
2658474|NCT01597687|Secondary|Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Malaysia|The travel costs were assessed in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM).|At time of questionnaire administration (Day 0)|The assessment was performed only on the Malaysian subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.|||Malaysian ringgit (RM)||Standard Deviation|Mean
2658462|NCT01597687|Secondary|Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Healthcare Resources in General - Malaysia|The medical costs were assessed in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the healthcare resources in general|At time of questionnaire administration (Day 0)|"The assessment was performed only on the Malaysian subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.~One subject who reported 'out of pocket expenses' did not report 'Total medical cost'."|||Malaysia - Malaysian ringgit (RM)||Standard Deviation|Mean
2658463|NCT01597687|Secondary|Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Thailand|The medical costs were assessed in the local currency of each country, as follows: Thailand - Thai baht (BAHT). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the emergency rooms.|At time of questionnaire administration (Day 0)|The assessment was performed only on the Thailandese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.|||Thai baht (BAHT)||Standard Deviation|Mean
2658464|NCT01597687|Secondary|Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Taiwan|The medical costs were assessed in the local currency of each country, as follows: Taiwan - New Taiwan dollar (NTD). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the emergency rooms.|At time of questionnaire administration (Day 0)|The assessment was performed only on the Taiwanese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.|||New Taiwan dollar (NTD)||Standard Deviation|Mean
2658465|NCT01597687|Secondary|Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Emergency Rooms - Malaysia|The medical costs were assessed in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the emergency rooms.|At time of questionnaire administration (Day 0)|The assessment was performed only on the Malaysian subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.|||Malaysian ringgit (RM)||Standard Deviation|Mean
2658466|NCT01597687|Secondary|Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Thailand|The medical costs were assessed in the local currency of each country, as follows: Thailand - Thai baht (BAHT). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the specialist clinics.|At time of questionnaire administration (Day 0)|The assessment was performed only on the Thailandese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.|||Thai baht (BAHT)||Standard Deviation|Mean
2658467|NCT01597687|Secondary|Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Taiwan|The medical costs were assessed in the local currency of each country, as follows: Taiwan - New Taiwan dollar (NTD). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the specialist clinics.|At time of questionnaire administration (Day 0)|The assessment was performed only on the Taiwanese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.|||New Taiwan dollar (NTD)||Standard Deviation|Mean
2658468|NCT01597687|Secondary|Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting Specialist Clinics - Malaysia|The medical costs were assessed in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the specialist clinics.|At time of questionnaire administration (Day 0)|The assessment was performed only on the Malaysian subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.|||Malaysian ringgit (RM)||Standard Deviation|Mean
2658469|NCT01597687|Secondary|Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Thailand|The medical costs were assessed in the local currency of each country, as follows: Thailand - Thai baht (BAHT). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the GP(s).|At time of questionnaire administration (Day 0)|The assessment was performed only on the Thailandese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.|||Thai baht (BAHT)||Standard Deviation|Mean
2658470|NCT01597687|Secondary|Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Taiwan|The medical costs were assessed in the local currency of each country, as follows: Taiwan - New Taiwan dollar (NTD). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the GP(s).|At time of questionnaire administration (Day 0)|The assessment was performed only on the Taiwanese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.|||New Taiwan dollar (NTD)||Standard Deviation|Mean
2658471|NCT01597687|Secondary|Assessment of Health Economical Impact - Summary of Medical Costs for Sero-confirmed Subjects Visiting the GP(s) - Malaysia|The medical costs were assessed in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM). Total medical cost included the cost spent for consultation, medicines, laboratory tests etc., for visiting the GP(s).|At time of questionnaire administration (Day 0)|"The assessment was performed only on the Malaysian subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.~One subject who reported 'out of pocket expenses' did not report 'Total medical cost'."|||Malaysian ringgit (RM)||Standard Deviation|Mean
2658472|NCT01597687|Secondary|Assessment of Health Economical Impact - Summary of Travel Costs for Sero-confirmed Subjects - Thailand|The travel costs were assessed in the local currency of each country, as follows: Thailand - Thai baht (BAHT).|At time of questionnaire administration (Day 0)|The assessment was performed only on the Tailandese subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.|||Thai baht (BAHT)||Standard Deviation|Mean
2658552|NCT01597388|Primary|AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 15 Intermittent Dosing, With Fulvestrant||15 Days||||h*ng/mL||Standard Deviation|Mean
2658475|NCT01597687|Secondary|Assessment of Health Economical Impact - Number of Visits to Specific Healthcare Resources|Healthcare resource utilization was assessed by the mean number of visits to any type of physicians.|At time of questionnaire administration (Day 0)|The assessment was performed only on the subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.|||Visits to physician||Standard Deviation|Mean
2658476|NCT01597687|Secondary|Assessment of Health Economical Impact - Number of Sero-confirmed Subjects With Loss of Income Due to Missing Work|Loss of income due to missing work for sero-confirmed subjects was measured in the local currency of each country, as follows: Malaysia - Malaysian ringgit (RM), Taiwan - New Taiwan dollar (NTD), Thailand - Thai baht (BAHT).|At time of questionnaire administration (Day 0)|The assessment was performed only on the subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥62.5 IU/ml, and with available data.|||Participants|||Count of Participants
2658477|NCT01597687|Secondary|Assessment of Health Economical Impact - Number of Days Absent From Work Due to Cough|Absenteeism was assessed as the mean number of days missed from work due to cough.|At time of questionnaire administration (Day 0)|The assessment was performed only on the subjects with sero-confirmed infection, i.e with Immunoglobulin G ELISA levels ≥ 62.5 IU/ml, and with available data.|||Days||Standard Deviation|Mean
2658478|NCT01597687|Secondary|Number of Participants With Specific Clinical Features|Clinical features assessed included paroxysm, whoop, night cough, cyanosis, fever post-tussive vomiting, apnoea, cyanosis, coughing up phlegm, sneezes, wheezes, episodes of being unable to stop coughing and breathlessness/chest pain.|At time of clinical data collection prior to enrolment (Day 0)|The analysis was done on the ATP cohort for immunogenicity which included all subjects with valid laboratory results. For this outcome the subjects were grouped by their infection status: Subjects with Sero-confirmed infection and Subjects with Non-sero-confirmed infection.|||Participants|||Count of Participants
2658479|NCT01597687|Primary|Serological Evidence of Pertussis Infection|Serological evidence of pertussis infection was defined as anti-pertussis toxin (PT) immunoglobulin G (IgG) level indicative of active or recent infection. The parameters presented were defined as follows: Seropositive = Subjects with anti-PT IgG ELISA levels ≥10 IU/ml , Seronegative = Subjects with anti-PT IgG ELISA levels < 10 IU/ml , Sero-confirmed infection = Subjects with anti-PT IgG ELISA levels ≥62.5 IU/ml , Active infection 1= Anti-PT IgG ELISA levels ≥ 100 IU/ml indicative of active or recent infection, Active infection 2 = Anti-PT IgG ELISA levels ≥ 125 IU/ml indicative of active or recent infection|At time of blood sampling (Day 0)|The analysis was done on the According-to-Protocol (ATP) cohort which included all subjects with valid laboratory results.|||Participants|||Count of Participants
2658480|NCT01597635|Secondary|Immunogenicity Assessment With Respect to Anti-ACE2 Binding Antibodies at Follow-up Day 14 and Follow-up Day 28 (Part B)|Blood samples for immunogenicity analysis were collected at follow-up (Day 14) and follow-up (Day 28). Antibodies to GSK2586881 were measured using a validated electrochemiluminescence bridging assay. All pre-dose and post-dose samples were first tested for Anti-ACE2 binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Testing was conducted using a tiered approach; samples were first tested in a screening assay, only samples found positive in this assay were tested in the confirmation assay.|Follow-up (Day 14 )and follow-up (Day 28)|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2658481|NCT01597635|Secondary|Immunogenicity Assessment With Respect to Anti-Acetychollinesterase2 (ACE2) Binding Antibodies at Follow-up Day 14 and Follow-up Day 28 (Part A)|Blood samples for immunogenicity analysis were collected at follow-up (Day 14) and follow-up (Day 28). Antibodies to GSK2586881 were measured using a validated electrochemiluminescence bridging assay. All pre-dose and post-dose samples were first tested for Anti-ACE2 binding antibodies by screening and confirmation assay steps. The post-dose samples tested positive for anti-ACE2 binding antibodies were further characterized for anti-ACE2 neutralizing antibodies. Testing was conducted using a tiered approach; samples were first tested in a screening assay, only samples found positive in this assay were tested in the confirmation assay.|Follow-up (Day 14) and follow-up (Day 28)|The All Subjects – Part A Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2658482|NCT01597635|Secondary|Biomarker Analysis for Markers of Lung Epithelial Cell Injury Clara Cell Protein 16 [CCP16]) and Surfactant Protein D [SP-D] Upto Day 5 (Part B)|Markers of lung epithelial cell injury included CCP16 and SP-D. Blood samples for biomarker analyses were collected 12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.|12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||nanograms per milliliter||95% Confidence Interval|Median
2658483|NCT01597635|Secondary|Biomarker Analysis for Serum Inflammatory Biomarker C-reactive Protein (CRP) Upto Day 5 (Part B)|Serum inflammatory biomarker included CRP. Blood samples for biomarker analyses were collected 12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.|12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||milligrams per deciliter||95% Confidence Interval|Median
2658484|NCT01597635|Secondary|Biomarker Analysis for Serum Inflammatory Biomarkers, Markers of Neutrophil Activation, Markers of Lung Epithelial Cell Injury, Renin Levels and Aldosterone Levels Upto Day 5 (Part B)|Serum inflammatory biomarkers included CXCL-8 [IL-8], IL-6, markers of neutrophil activation included (e.g. myeloperoxidase [MPO]), markers of lung epithelial cell injury included receptor for advanced glycation end-products [RAGE], Angiopoietin 2, along with rennin, aldosterone levels. Blood samples for biomarker analyses were collected 12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.|12 hours, 24 hours, 48 hours, 72 hours and 120 hours upto Day 5|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||picograms per milliliter||95% Confidence Interval|Median
2658553|NCT01597388|Primary|Time to AZD2014 Peak Plasma Concentration at Steady State (Tmax,ss) on Cycle 1 Day 15, BID Intermittent Dosing, With Fulvestrant||15 Days||||hours||Full Range|Median
2658485|NCT01597635|Secondary|Evaluation of Sequential Organ Failure Assessment (SOFA) Score on Day 4 and Day 7 (Part B)|The SOFA score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). The score ranges from 0-24. 0 (normal) to 4 (high degree of dysfunction) is given for each organ system, with a higher score indicating greater severity. A score of 0-6 is associated with a mortality rate of less than 10% while a score between 16 and 24 is associated with a greater than 90% mortality rate.|Day 4 and Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||Score on scale||95% Confidence Interval|Mean
2658486|NCT01597635|Secondary|Number of Participants With Acute Kidney Injury as Defined by Day 1 to Day 3 Change in Risk, Injury, Failure, Loss of Kidney Function, and End-stage Kidney Disease (RIFLE) Criteria Upto Day 3 (Part B)|The RIFLE score is made up of the glomerular filtration rate criteria (GFRC) and urine output criteria (UOC) and is defined as Risk (Serum Creatinine x 1.5 or GFR decrease > 25%-GFRC and < 0.5 milliliter/kilograms/hour [ml/kg/hour] x 6 hours-UOC), Injury (Serum Creatinine x 2 or GFR decrease > 50%-GFRC and < 0.5 ml/kg/hour x 12 hours), Failure (Serum Creatinine x 3, or GFR decrease > 75% [F=Failure] or Serum Creatinine >=4 milligrams/deciliter [mg/dl] with an acute rise > 0.5 mg/dl [Fc=Failure acute on chronic] and < 0.3 ml/kg/hour x 24 hours, or anuria x 12 hours [Fo=Failure oligouria]). Due to the duration of this study it was not possible to be calculate the designated RIFLE class Loss and RIFLE class End-stage kidney disease. Data has been presented for rifle score total, rifle score GFR and rifle score urine. Abbreviations NAKI= No acute kidney injury, R=risk, I=injury, MISS= Unable to derive score.|Upto Day 3|The All Subjects – Part B Population.|||Participants|||Number
2658487|NCT01597635|Secondary|Measure of Oxygenation Index Upto Day 7 (Part B)|Oxygenation index was defined as calculation used in intensive care medicine to measure the fraction of inspired oxygen (FiO2) and its usage within the body and was computed using the equation Oxygenation Index= FiO2 x Mean Airway Pressure/Pao2. Assessments were performed at 0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7. Data has been presented for median along with the 95% credible interval.|0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||Percentage||95% Confidence Interval|Median
2658488|NCT01597635|Secondary|Measure of Oxygenation Including Fraction of Inspired Oxygen/ Partial Pressure of Oxygen in Arterial Blood (PaO2/FiO2) Ratio Via Pulse Oximetry Upto Day 7 (Part B)|"Measure of oxygenation included PaO2/FiO2 ratio defined as the ratio of arterial oxygen partial pressure to fractional inspired oxygen by pulse oximeter a device that measured the oxygen saturation of arterial blood in a participant by utilizing a sensor attached typically to a finger, toe, or ear to determine the percentage of oxyhemoglobin in blood pulsating through a network of capillaries.~Assessments were performed at 0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7. Data has been presented for median along with the 95% credible interval."|0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||Ratio||95% Confidence Interval|Median
2658489|NCT01597635|Secondary|Measures of Oxygenation Including Level of Positive End Expiratory Pressure (PEEP), Peak Ventilatory Pressures and Plateau Ventilatory Pressures Upto Day 7 (Part B)|Measures of oxygenation included PEEP the pressure in the lungs (alveolar pressure) above atmospheric pressure (the pressure outside of the body) that exists at the end of expiration, peak ventilator pressure highest level of pressure applied to the lungs during inhalation and plateau ventilatory pressure the pressure applied to small airways and alveoli measured during an inspiratory pause on the ventilator. Assessments were performed at 0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7. Data has been presented for median along with the 95% credible interval.|0.5, 1, 2, 4, 6, 8, 12, 18, 24, 24.5, 25, 26, 28, 30, 32, 36, 42, 48, 48.5, 49, 50, 52, 54, 56, 60, 66, 72 and 168 hours upto Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||centimeters of water pressure||90% Confidence Interval|Median
2658490|NCT01597635|Secondary|Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Ang II/Ang (1-5) and Ang II/Ang (1-7) Upto Day 5(Part B)|Renin-angiotensin system cascade biomarkers included Ang II/Ang (1-5) and Ang II/Ang (1-7) and). Blood samples for biomarker analyses were collected 0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.|0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5.|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||Ratio||95% Confidence Interval|Median
2658491|NCT01597635|Secondary|Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Ang II, Ang (1-7) and Ang (1-5) Upto Day 5(Part B)|Renin-angiotensin system cascade biomarkers included Ang II, Ang (1-7) and Ang (1-5). Blood samples for biomarker analyses were collected 0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5. Data has been presented for median along with the 95% credible interval.|0.5 hours, 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, 48.5 hours, 50 hours, 54 hours, 60 hours, 66 hours, 72 hours, 96 hours and 120 hours upto Day 5.|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||picograms per milliliter||95% Confidence Interval|Median
2658492|NCT01597635|Secondary|Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Ang II/ Ang (1-7) Upto Day 2 (Part A)|Renin-angiotensin system cascade biomarkers included Ang II/Ang (1-7). Blood samples for biomarker analyses were collected at Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours on Day 1 and 0 hours, 1 hour, 12 hours and 24 hours on Day 2.|Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1) and 0 hours, 1 hour, 12 hours and 24 hours (Day 2).|All Subjects – Part A Population.|||Ratio||95% Confidence Interval|Geometric Mean
2658554|NCT01597388|Primary|AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 1 Day 15, BID Intermittent Dosing, With Fulvestrant||15 Days||||ng/mL||Standard Deviation|Mean
2658493|NCT01597635|Secondary|Pharmacodynamic/Biomarker Analysis (Renin-angiotensin System Cascade Biomarkers) to Include Angiotensin (Ang) II and Ang (1-7) Upto Day 2 (Part A)|Renin-angiotensin system cascade biomarkers included Ang II and Ang (1-7). Blood samples for biomarker analyses were collected at Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1) and 0 hours, 1 hour, 12 hours and 24 hours on Day 2.|Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1) and 0 hours, 1 hour, 12 hours and 24 hours (Day 2).|All Subjects – Part A Population|||picograms per milliliter||95% Confidence Interval|Geometric Mean
2658494|NCT01597635|Secondary|Analysis Pharmacokinetic Parameter Clearance (CL) for GSK2586881 (Part B)|Blood samples for pharmacokinetic analysis of GSK2586881 were collected at Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours and 48 hours. CL was defined as the systemic clearance of parent drug. Clearance was calculated for individual participant and geometric mean of the values from all participants was reported.|Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours, 48 hours|Pharmacokinetic - Part B Population.|||liters per hour||Standard Error|Geometric Mean
2658495|NCT01597635|Secondary|Analysis of Pharmacokinetic Parameter Clearance (CL) for GSK2586881 (Part A)|Blood samples for pharmacokinetic analysis of GSK2586881 were collected at Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours and 48 hours. CL was defined as the systemic clearance of parent drug. Clearance was calculated for individual participant and geometric mean of the values from all participants was reported.|Pre-dose, 0 hour, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours, 24 hours, 25 hours, 36 hours, 48 hours|Pharmacokinetic - Part A Population.|||liters per hour||Standard Error|Geometric Mean
2658496|NCT01597635|Secondary|Analysis of GSK2586881 Plasma Pharmacokinetic Concentration (Part B)|Blood samples for pharmacokinetic analysis of GSK2586881 were collected Pre-dose, 0.5 Hours, 2 hours, 6 hours, 12 hours (Day 1), 0 hours (Day 2), 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours (Day 3). Data has been presented for GSK2586881 Plasma Pharmacokinetic Concentration versus time data for Part B.|Pre-dose, 0.5 Hours, 2 hours, 6 hours, 12 hours (Day 1), 0 hours (Day 2), 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours (Day 3)|The Pharmacokinetic - Part B Population was defined as participants in the All Subjects – Part B population for whom a pharmacokinetic sample was obtained and analyzed and a result reported and received an active dose of GSK2586881. Only those participants with data available at the indicated time points were analyzed.|||nanograms per milliliter||Standard Deviation|Mean
2658497|NCT01597635|Secondary|Analysis of GSK2586881 Plasma Pharmacokinetic Concentration (Part A)|Blood samples for pharmacokinetic analysis of GSK2586881 were collected Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1), 0 hours, 1 hour, 12 hours, 24 hours (Day 2). Data has been presented for GSK2586881 Plasma Pharmacokinetic Concentration versus time data for Part A|Pre-dose, 5 minutes, 10 minutes, 2 hours, 6 hours, 10 hours, 12 hours (Day 1), 0 hours, 1 hour, 12 hours, 24 hours (Day 2)|The Pharmacokinetic - Part A Population was defined as participants in the All Subjects – Part A population for whom a pharmacokinetic sample was obtained and analyzed and a result reported and received an active dose of GSK2586881.|||nano grams per milliliter||Standard Deviation|Mean
2658498|NCT01597635|Primary|Number of Par With AE and Serious Adverse Event (SAE) Assessment Upto Day 7 (Part B)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Up to Day 7|All Subjects – Part B Population.|||Participant|||Number
2658499|NCT01597635|Primary|Number of Participant With Adverse Event (AE) and Serious Adverse Event (SAE) Assessment Upto Day 7 (Part A)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Up to Day 7|The All Subjects – Part A Population was defined as all participants in Part A who received at least one dose of study medication.|||Participants|||Number
2658500|NCT01597635|Primary|Clinical Chemistry Parameters Albumin and Total Protein Assessment Upto Day 7 (Part B)|Clinical chemistry parameters included albumin and total protein. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||grams per liter||Standard Deviation|Mean
2658501|NCT01597635|Primary|Clinical Chemistry Parameters Alkaline Phosphatase, Asparatate Amino Transferase, Alanine Amino Transferase, Gamma Glutamyl Transferase Assessment Upto Day 7 (Part B)|Clinical chemistry parameters included alkaline phosphatase, asparatate amino transferase, alanine amino transferase, gamma glutamyl transferase. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||International units per liter||Standard Deviation|Mean
2658502|NCT01597635|Primary|Clinical Chemistry Parameters Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid Assessment Upto Day 7 (Part B)|Clinical chemistry parameters included direct bilirubin, total bilirubin, creatinine and uric acid. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||micromoles per liter||Standard Deviation|Mean
2658503|NCT01597635|Primary|Clinical Chemistry Parameters Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen Assessment Upto Day 7 (Part B)|Clinical chemistry parameters included calcium, chloride, carbon dioxide, glucose, potassium, sodium, Urea/Blood urea nitrogen. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||millimoles per liter||Standard Deviation|Mean
2658504|NCT01597635|Primary|Hematology Parameter Hematocrit Assessment Upto Day 7 (Part B)|Hematology parameter included hematocrit. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||Fraction||Standard Deviation|Mean
2658505|NCT01597635|Primary|Hematology Parameter Mean Corpuscle Hemoglobin (MCH) Assessment Upto Day 7 (Part B)|Hematology parameter included MCH. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||picograms||Standard Deviation|Mean
2658506|NCT01597635|Primary|Hematology Parameter Mean Corpuscle Volume (MCV) Assessment Upto Day 7 (Part B)|Hematology parameter included MCV. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||femtoliters||Standard Deviation|Mean
2658507|NCT01597635|Primary|Hematology Parameter Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Assessment Upto Day 7 (Part B)|Hematology parameters included hemoglobin and MCHC. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||grams per liter||Standard Deviation|Mean
2658508|NCT01597635|Primary|Hematology Parameters Red Blood Cell Count and Reticulocyte Count Assessment Upto Day 7 (Part B)|Hematology parameters included red blood cell count and reticulocyte count. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||trillion cells per liter||Standard Deviation|Mean
2658509|NCT01597635|Primary|Hematology Parameters Basophils, Eosinophil, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell Count Upto Day 7 (Part B)|Hematology parameters included basophils, eosinophil, lymphocytes, monocytes, total neutrophils, platelet count and white blood cell count. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||giga per liter||Standard Deviation|Mean
2658510|NCT01597635|Primary|Electrocardiogram (ECG) Parameters, Including PR, QRS, QT, and QTCU and RR Intervals Upto Day 7 (Part B)|Single 12-lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTCU and RR intervals. Assessments were performed at Pre-dose on Day 1, at 12 hours on Day 3 and at follow-up Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||millisecond||Standard Deviation|Mean
2658511|NCT01597635|Primary|Diastolic and Systolic Blood Pressure Assessments Upto Day 7 (Part B)|Vital sign included systolic blood pressure and diastolic blood pressure. Assessments were performed at Pre-dose, 0.5 hours, 2 hours, 6 hours and 12 hours on Day 1, 0 hours on Day 2 at 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours on Day 3 and at follow-up on Day 7.|Up to Day 7|The All Subjects – Part B Population. Only those participants available at the specified time points were analyzed.|||Millimeters of merucry||Standard Deviation|Mean
2658512|NCT01597635|Primary|Heart Rate Assessments Upto Day 7 (Part B)|Vital sign included heart rate. Assessments were performed at Pre-dose, 0.5 hours, 2 hours, 6 hours and 12 hours on Day 1, 0 hours on Day 2 at 0 hours, 0.5 hours, 2 hours, 6 hours, 12 hours, 18 hours and 24 hours on Day 3 and at follow-up on Day 7.|Up to Day 7|The All Subjects – Part B Population was defined as all participants in Part B who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2658513|NCT01597622|Secondary|Percentage of SLE Responder Index (SRI) Responders by Study Visit|SRI response is composite index, defined as percent of participants with>=4 point reduction from Baseline in safety of estrogen in lupus national assessment systemic lupus erythematosus disease activity index (SELENA-SLEDAI) score and no worsening (increase of <0.30 points from Baseline) in physicians global assessment(PGA) &no new British isles lupus assessment group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0(no activity) to 3(severe activity). BILAG has no range. Baseline is last available value prior to first belimumab exposure. Year 8 Week 24 visit is the Exit Visit obtained by slotting the Exit Visit to Week 24. Timeframe includes exposure in parent study/upto 4 weeks post infusion (Exit visit) in current study (114333).|Study Years 1 to 7: At Week 24 and 48 Visits, Year 8: only Week 24 Visit|Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category title)|||Percentage of Participants|||Number
2658514|NCT01597622|Primary|Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)|Any untoward medical occurrence in participant, temporally associated with use of medicinal product, whether or not considered related to medicinal product. Any untoward event resulting in death,life threatening,requires hospitalization or prolongation of existing hospitalization,results in disability/incapacity,congenital anomaly/birth defect,medically important were categorized as SAE. Number of participants who had any AE(includes those having non-serious and/or serious AEs) or any SAE are presented.Treatment-emergent AEs are defined as AEs that started on or after first dose of belimumab treatment and for those participants who were randomized to placebo in parent study,ongoing AEs that started before first open-label belimumab dose(in either C1115 open-label extension or BEL114333),worsened (severity,seriousness,relatedness) at any point during the open-label treatment.Timeframe includes exposure in parent study/upto16 weeks post infusion in current study(114333).|Up to 6 calendar years and 9 months|Safety Population. All participants in the Enrolled population who received at least one IV dose of belimumab during current study.|||Participants|||Count of Participants
2658515|NCT01597596|Secondary|Change From Baseline in Motor Development Status at Week 52|Motor development status was assessed by the Gross Motor Function Measure - 88 Scale (GMFM-88) total percent scores. GMFM-88 is an 88-item measure to detect gross motor function. It consists of 5 categories: lying and rolling; sitting; crawling and kneeling; standing; walking, running and jumping. Each item was scored on a 4-point Likert scale (0 = cannot do; 1 = initiates [<10% of the task]; 2 = partially completes [10% to <100% of the task]; 3 = task completion). The score for each dimension was expressed as a percentage of the maximum score for that dimension. Total score ranges from 0% to 100%, where higher scores indicate better motor functions.|Baseline, Week 52|Full analysis population. For this endpoint no participants were analyzed in 'Algucosidase Alfa 4000 L material’ arm at Baseline and Week 52. One participant from ‘Algucosidase Alfa 160 L Material’ arm was discontinued from study at Week 31 due to physician’s decision.|||percentage of maximum total score||Standard Deviation|Mean
2658516|NCT01597596|Secondary|Number of Participants With Invasive Ventilator-Free Survival|Invasive ventilator-free survival was defined as the time during which the participant is alive and not invasively ventilated. Number of Participants with invasive ventilator-free survival were reported.|Up to Week 52|Full analysis population.|||participants|||Number
2658517|NCT01597596|Secondary|Percentage of Participants With Estimated Probability of Survival||Up to Week 52|Full analysis population.|||percentage of participants|||Number
2658518|NCT01597596|Primary|Change From Baseline in Cardiac Function at Week 52|Cardiac function was measured by the left ventricular mass Z-score (LVM-Z). Z-Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. A negative change from baseline indicates a decrease and positive change from baseline indicates an increase in LVM Z-score. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy.|Baseline, Week 52|Full analysis population defined as all participants who receive at least 1 infusion of alglucosidase alfa. For this endpoint no participants were analyzed in 'Algucosidase Alfa 4000 L material’ arm at Baseline and Week 52. One participant from ‘Algucosidase Alfa 160 L Material’ arm was discontinued from study at Week 31 due to physician’s decision|||Z-score||Standard Deviation|Mean
2658519|NCT01597505|Secondary|Adjusted Percentage of Participants From the Per Protocol 2 Population With a Sustained Clinical Response at the End of Study|Sustained clinical response at the end of study was achieved by participants who had a clinical outcome of cure at the end of treatment (Days 40-50) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. Only the first failure event per participant was counted. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.|Up to Day 50|The Per Protocol 2 (PP2) population composed of cures and failures from the PP1 population. Additionally, to be included in the PP2 population, PP1 participants who were cured at end of treatment must not have had any protocol deviations which could affect the assessment of recurrence and have had follow-up contact through at least Day 40.|||Percentage of participants||95% Confidence Interval|Number
2658520|NCT01597505|Secondary|Adjusted Percentage of Participants With a Sustained Clinical Response at the End of Study for Infections Deemed to be Caused by the C. Difficile BI/NAP1/027 Strain at Baseline|Sustained clinical response at the end of study was achieved by participants with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline, who had a clinical outcome of cure at the end of treatment (Day 13) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.|Up to Day 50|All randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized; and with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline|||Percentage of participants||95% Confidence Interval|Number
2658521|NCT01597505|Secondary|Adjusted Percentage of Participants Per Protocol 1 Population With a Clinical Response at the End of Treatment|Clinical response corresponded to a clinical outcome of cure at the end of treatment, and was achieved by participants who did not fail treatment, did not die, or were not lost to follow-up at the end of treatment. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.|Up to Day 13|The population analyzed is the Per Protocol 1 (PP1) population composed of participants from the mMITT population, according to the actual treatment they received; without any protocol deviations from enrollment through 2 days after end of treatment, which could affect the efficacy conclusions.|||Percentage of participants||95% Confidence Interval|Number
2658522|NCT01597505|Secondary|Adjusted Percentage of Participants With a Clinical Response at the End of Treatment for Infections Deemed to be Caused by the C. Difficile BI/NAP1/027 Strain at Baseline|Clinical response corresponded to a clinical outcome of cure at the end of treatment, and was achieved by participants with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline, who did not fail treatment, did not die, or were not lost to follow-up at the end of treatment. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.|Up to Day 13|Randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized; and with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline.|||Percentage of participants||95% Confidence Interval|Number
2658523|NCT01597505|Secondary|Time to Reappearance of Diarrhea From End of Treatment to the End of Study|Time to reappearance of diarrhea with >= 3 UBM per 24-hour period was calculated as the last date/time of study drug dose to the date/time of first reappearance of 3 or more UBMs among participants who were cured at end of treatment.|Up to Day 50|The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized; and were cured at end of treatment.|||Days||95% Confidence Interval|Median
2658524|NCT01597505|Secondary|Time to Resolution of Diarrhea|Time to resolution of diarrhea with =< 2 unformed bowel movements (UBM) per 24-hour period was calculated as the date/time of last UBM minus the date/time of the first dose of study drug.|Up to Day 13|The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized|||Days||95% Confidence Interval|Median
2658525|NCT01597505|Secondary|Adjusted Percentage of Participants With Recurrence of CDAD at End of Study|Participants with recurrences were defined as those who were cured at the end of therapy and had a recurrence or were lost to follow-up, died or had a Day 40 -50 contact prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.|Up to Day 50|The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2658526|NCT01597505|Secondary|Adjusted Percentage of Participants With Sustained Clinical Response at Day 24|Sustained clinical response at Day 24 was defined as participants who had a clinical outcome of cure at Day 24, who did not experience a recurrence of CDAD, did not die, were not lost to follow-up. Only the first failure event was counted per participant. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.|Day 24|The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2658527|NCT01597505|Primary|Percentage of Participants Who Discontinued Treatment Due to an AE|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings).|Up to Day 13|All randomized participants who received any amount of study drug|||Percentage of participants|||Number
2658528|NCT01597505|Primary|Percentage of Participants With at Least One Serious Adverse Event (SAE)|A SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death; a life-threatening experience, referring to a situation in which the participant was at risk of death at the time of the event, requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; or is considered to be an important medical event.|Up to Day 50|All randomized participants who received any amount of study drug|||Percentage of participants|||Number
2658529|NCT01597505|Primary|Percentage of Participants With at Least One Adverse Event (AE)|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings).|Up to Day 50|All randomized participants who received any amount of study drug|||Percentage of participants|||Number
2658530|NCT01597505|Secondary|Adjusted Percentage of Participants With Sustained Clinical Response at the End of Study|Sustained clinical response at the end of study was achieved by participants who had a clinical outcome of cure at the end of treatment (Days 40-50) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.|Up to Day 50|The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2658531|NCT01597505|Secondary|Number of Participants With Clinical Response Over Time|Clinical response over time as measured by those without treatment failure, recurrence, death, or lost to follow-up, measured as the number of participants without failure events (survivors) through the end of therapy (reported for Day 14) and from end of therapy to Day 40 (reported for Day 41).|Up to Day 41|The mMITT population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized|||Participants|||Count of Participants
2658532|NCT01597505|Primary|Adjusted Percentage of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT)|A clinical outcome of cure at EOT was determined by resolution of diarrhea, defined as ≤ 2 loose stools per 24-hour period for at least 2 consecutive days and the lack of need for additional antibiotics to treat the current CDAD episode after completion of the study treatment period. Participants requiring a collection device were considered to have resolution of diarrhea when the volume of stool (over a 24-hour period) was decreased by 75% as compared to baseline or the participant was no longer passing liquid stool. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights.|Up to 13 days|The population analyzed is the Microbiological Modified Intent-To-Treat (mMITT) population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2658555|NCT01597388|Primary|AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-∞) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant||5 Days||||h*ng/mL||Standard Deviation|Mean
2658556|NCT01597388|Primary|AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-t) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant||5 Days||||h*ng/mL||Standard Deviation|Mean
2658557|NCT01597388|Primary|AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-24) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant||5 Days||||h*ng/mL||Standard Deviation|Mean
2658558|NCT01597388|Primary|AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant||5 Days||||h*ng/mL||Standard Deviation|Mean
2658559|NCT01597388|Primary|AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 0 Days -5 to -1, Continuous Dosing, no Fulvestrant||5 Days||||ng/mL||Standard Deviation|Mean
2658533|NCT01597492|Primary|Number of Participants With Positive Antibody Responses to at Least One of the 23 Pneumococcal Vaccine Serotypes 4 Weeks Post-vaccination|A positive immune response to at least one pneumococcal serotype is defined as a 2-fold or greater increase from pre-vaccination levels. For unquantifiable pre-vaccination antibody levels, a positive antibody response was considered as a post-vaccination level >=0.6 micrograms (µg)/milliliter (mL). Post-vaccination pneumococcal titers were assessed on Day 28 (Week 4) prior to the first dose of belimumab in the early cohort and on Day 196 (Week 28) prior to the last belimumab dose in the late cohort. Evaluable participants for the early cohort included those who received the vaccination at Day 0 and had titers drawn at Week 4. For the late cohort, evaluable participants received at least 5 of the 7 doses of belimumab up through Week 24, received the vaccination at Week 24, and had titers drawn at Week 28.|Four weeks after vaccination|As-treated Population: all participants who received at least one dose of belimumab. All analyses of vaccine titers were performed on the As-treated Population.|||Participants|||Number
2658534|NCT01597479|Secondary|Maximum Pain Intensity, Rescue Analgesia, Nausea and Vomiting Incidence, Use of Ondansetron for NVPO, Efectiveness of Ondansetron|Number of participants with Maximum pain intensity NVS > 3; Rescue analgesia; Nausea and Vomiting incidence; use of ondansetron for NVPO; Ondansetron being effective (number of participants for whom ondansetron was effective to stop NVPO).|Up to 48 hours|Patients undergoing ambulatory thumb resection arthroplasty|||participants|||Number
2658535|NCT01597479|Primary|Proportion of Patients Who Experienced Moderate to Severe Pain During First and Second Postoperative Day|Pain scores assessed using pain numerical visual scale (NVS) of 0-10 (o= no pain and 10= worst pain imaginable). We defined mild pain (NVS 0-3); moderate pain (NVS 4-6) and severe pain (NVS 7-10).The analysis of this variable at the end of the study will confirm or not the effectiveness of dPNBs for management of postoperative pain after TRA.|Up to 48 hours|Patients undergoing ambulatory thumb resection arthroplasty (TRA)|||percentage of patients|||Number
2658536|NCT01597440|Secondary|Number of Participants With Adverse Events|Safety is measured by tracking and detailing the number and type of adverse events and their severity based on the CTCAE.|Start of episode through 7 days or discharge (if earlier)||||Participants|||Number
2658537|NCT01597440|Primary|Neurodevelopment|Neurodevelopmental outcome as measured by Cognitive Composite (Bayley III), Motor Composite (Bayley III) and Functional Status Scale and safety of NCG treatment as measured by adverse events and laboratory blood tests|30 months|The study was closed prematurely. There is no analysis population.||||||
2658538|NCT01597388|Secondary|Progression Free Survival at 26 Weeks||Up to 12 months|"The tumour assessment analysis set consisted of all participants who received at least one dose of AZD2014 and fulvestrant and had a baseline tumour assessment."|||Percentage||80% Confidence Interval|Number
2658539|NCT01597388|Secondary|Progression Free Survival||Up to 12 months|"The tumour assessment analysis set consisted of all participants who received at least one dose of AZD2014 and fulvestrant and had a baseline tumour assessment."|||Weeks||80% Confidence Interval|Median
2658540|NCT01597388|Secondary|Percentage Change From Baseline at 16 Weeks in Target Lesion (TL) Size.|Baseline was defined as last evaluable assessment prior to starting treatment. Tumour size was the sum of the longest diameters of the target lesions. TLs are measurable tumour lesions.|Up to 12 months|"The evaluable for response analysis set consisted of all participants who received at least one dose of AZD2014 and fulvestrant and had measurable disease at baseline per RECIST v1.1."|||Percentage Change||Standard Deviation|Mean
2658541|NCT01597388|Secondary|Clinical Benefit Rate (CBR) at 24 Weeks|The Clinical Benefit Rate (CBR) at 24 weeks is defined as the percentage of patients who had a confirmed BOR of CR or PR in the first 24 weeks or who demonstrated SD for a minimum interval of 24 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e., 161 days) following the start of treatment.|Up to 12 months|"The tumour assessment analysis set consisted of all participants who received at least one dose of AZD2014 and fulvestrant and had a baseline tumour assessment."|||Participants|||Number
2658542|NCT01597388|Secondary|Duration of Response (DoR)|Duration of response is defined as the time from the date of first documented response until the date of documented progression or death in the absence of disease progression.|Up to 12 months|The number of participants analyzed for Duration of Response is zero in cohorts which had no responders [35 mg BID Continuous and 170 mg BID Intermittent Days 1 and 2 (fed)]|||Months||Inter-Quartile Range|Median
2658543|NCT01597388|Secondary|Best Objective Response (BOR)|Best objective response was the best response a patient had following start of treatment but prior to starting any subsequent cancer therapy and prior to RECIST v1.1 progression or the last evaluable assessment in the absence of RECIST v1.1 progression.|Up to 12 months|The population consisted of all patients receiving at least one dose of AZD 2014 and fulvestrant with measurable disease at baseline per RECIST v1.1.|||Participants|||Number
2658544|NCT01597388|Secondary|Objective Response Rate|Objective Response Rate (ORR) is defined as the number (%) of patients with a confirmed overall response of either complete response (CR) or partial response (PR).|Up to 12 months|The population consisted of all patients receiving at least one dose of AZD 2014 and fulvestrant with measurable disease at baseline per RECIST v1.1.|||Participants|||Number
2658545|NCT01597388|Secondary|Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to Infinity (AUC 0-∞) Following Single Dose, Fasted, no Fulvestrant.||1 Day||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2658546|NCT01597388|Secondary|Area Under the Plasma Concentration-time Curve for AZD2014 From 0 to 12 Hours (AUC 0-12) Following Single Dose, Fasted, no Fulvestrant.||1 Day||||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2658547|NCT01597388|Secondary|Time to AZD2014 Peak Plasma Concentration (Tmax) Following Single Dose, Fasted, no Fulvestrant.||1 Day||||hour||Full Range|Median
2658548|NCT01597388|Secondary|AZD2014 Peak Plasma Concentration (Cmax) Following Single Dose, Fasted, no Fulvestrant.||1 Day||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2658549|NCT01597388|Primary|AZD2014 Area Under the Plasma Concentration Time Curve (AUC 0-12) Cycle 1 Day 22 Continuous Dosing, With Fulvestrant||15 Days||||h*ng/mL||Standard Deviation|Mean
2658550|NCT01597388|Primary|Time to AZD2014 Peak Plasma Concentration at Steady State (Tmax,ss) on Cycle 1 Day 22, Continuous Dosing, With Fulvestrant||22 Days||||hours||Full Range|Median
2658551|NCT01597388|Primary|AZD2014 Peak Plasma Concentration at Steady State (Cmax,ss) on Cycle 1 Day 22, Continuous Dosing, With Fulvestrant||22 Days||||ng/mL||Standard Deviation|Mean
2658574|NCT01597375|Other Pre-specified|Baseline Differences in Platelet Chemistry in Subjects With AERD Compared to Controls|To determine if there are baseline differences in the percentages of activated platelets, platelet-leukocyte aggregates, or the plasma levels of soluble platelet products in subjects with AERD, compared to aspirin tolerant asthmatics (ATA) and non-asthmatic controls.|Evaluated at visit 1 (week 4)|||||||
2658575|NCT01597375|Secondary|Change From Baseline in Prostaglandin Metabolites (PGD-M) Measurement After Aspirin Desensitization and High Dose Aspirin Treatment at 8 Weeks|We will note difference in the Prostaglandin metabolites (PGD-M) measurement obtained before any treatment ( baseline ) and after one day Aspirin desensitization followed by 8 weeks Aspirin treatment ( 650 mg oral aspirin tablet twice daily )|Evaluated at baseline and reported at 8 weeks|This was assessed across all participants with no planned comparisons between placebo and prasugrel.|||ng/mg creatinine||Standard Deviation|Mean
2658576|NCT01597375|Secondary|Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) Score After Aspirin Desensitization and High Dose Aspirin Treatment at 8 Weeks|We will note difference in the Asthma Control Questionnaire-7 (ACQ-7) score [ The ACQ has 7 questions on a 7-point scale (minimum score of 0=no impairment, maximum score of 6= maximum impairment)] obtained before any treatment ( baseline ) and after one day Aspirin desensitization followed by 8 weeks Aspirin treatment ( 650 mg oral aspirin tablet twice daily )|Evaluated at baseline and reported at 8 weeks|This was assessed across all participants with no planned comparisons between placebo and prasugrel.|||score on a scale||Standard Deviation|Mean
2658577|NCT01597375|Secondary|Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Measurement After Aspirin Desensitization and High Dose Aspirin Treatment at 8 Weeks|We will note difference in the fractional exhaled nitric oxide (FeNO) obtained before any treatment ( baseline ) and after one day Aspirin desensitization followed by 8 weeks Aspirin treatment ( 650 mg oral aspirin tablet twice daily )|Evaluated at baseline and reported at 8 weeks|This was assessed across all participants with no planned comparisons between placebo and prasugrel.|||parts per billion||Standard Deviation|Mean
2658578|NCT01597375|Secondary|Change in Urinary LTE4 During Aspirin Challenge on Placebo Versus Prasugrel|We will compare the participant's Leukotriene E4 (LTE4) obtained from the aspirin challenge done after pretreatment with prasugrel, the aspirin challenge done after pretreatment with placebo.|Change from visits 2 at visit 3 (weeks 8, 14), calculated and reported at visit 3||||percentage change from baseline||Standard Deviation|Mean
2658579|NCT01597375|Secondary|Change in Total Nasal Symptom Score(TNSS)From Baseline to Peak During Aspirin Challenge on Placebo Versus Prasugrel.|The primary outcome in Part 1 will be the maximum Total Nasal Symptom Score (TNSS) attained for subjects with AERD during the clinical reaction to aspirin challenge. The primary analysis will compare this outcome within each participant after treatment with prasugrel versus placebo. Nasal symptoms including congestion, rhinorrhea, runny nose, itchy nose, sneezing, itchy eyes, teary eyes, itchy ears/throat, and eye redness were assessed on a 0- to 5-point scale (0, none-5, very severe) in response to the provocative dose of aspirin during aspirin challenge/desensitization and summed together to generate the TNSS score (range 0-40).|Data obtained at visits 2 and 3 (weeks 8 and 14) and change calculated at visit 3||||units on scale||Standard Error|Mean
2658580|NCT01597375|Secondary|Difference in Participant's Provocative Dose of Aspirin When Pretreated With Prasugrel Versus Placebo|We will monitor the dose of aspirin at which the participant shows symptoms (increased discomfort, 15% drop in FEV1) during the aspirin challenge/desensitization. We will compare the provocative aspirin dose obtained from the aspirin challenge occurring after pretreatment with prasugrel to the dose obtained after pretreatment with placebo.|Evaluated at visits 2 and 3 (weeks 8 and 14)||||mg||Standard Error|Mean
2658581|NCT01597375|Primary|Change From Baseline Expression Levels of COX-2 Transcript and Protein in Peripheral Blood Leukocytes of Subjects With AERD After 8 Weeks of Treatment With Aspirin.|This study will compare this outcome within each participant between baseline (established at Visit 1, prior to initiation of prasugrel therapy) and at the completion of 8 weeks of aspirin therapy.|Evaluated at visits 1 and 4 (weeks 4 and 22)|The planned experimental protocol for COX-2 analysis at the lab bench was unsuccessful, therefore no data was collected for this Outcome Measure||||||
2658582|NCT01597375|Primary|Difference in PD2 (Provocative Dose of Aspirin That Elicits an Increase in Nasal Symptom Score of 2 During an Aspirin Challenge) on Prasugrel Versus Placebo|"The PD2 is the provocative dose of aspirin that elicits an increase in nasal symptom score of 2 during an aspirin challenge. The PD2 is calculated by:~inverse〖log〗_10 (((2-(PrevTNSS-BaselineTNSS))×(〖log〗_10 ProvocDose-〖log〗_10 PrevDose))/((MaxTNSS-BaselineTNSS)-(PrevTNSS-BaselineTNSS) )+(〖log〗_10 PrevDose))"|Difference in PD2 (provocative dose of aspirin that elicits an increase in nasal symptom score of 2 during an aspirin challenge) between Visits 2 and 3 (weeks 8 and 14), calculated at visit 3||||mg||Standard Error|Mean
2658583|NCT01597258|Secondary|Objective Response Rate (ORR) at 52 Weeks|"Clinical effectiveness of XALKORI Capsules was assessed as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or indeterminate by the physician, based on Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1. Overall effectiveness of XALKORI Capsules was determined by the physician based on the best response. Clinical effectiveness rate was ORR, defined as the percentage of subjects achieving CR or PR with best response. The ORR was presented along with the corresponding exact 2-sided 95% confidence interval (CI)."|52 weeks|The efficacy analysis set (EAS) is comprised in the safety analysis set who had at least one measurable lesion and were evaluated for effectiveness. 1633 participants were included in the EAS.|||Percentage of participants||95% Confidence Interval|Number
2658584|NCT01597258|Primary|Number of Participants With Adverse Drug Reactions|An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XALKORI Capsules in a participant who received XALKORI Capsules. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XALKORI Capsules was assessed by the physician.|52 weeks|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received XALKORI Capsules at least once.|||Participants|||Number
2658686|NCT01596283|Primary|Postoperative Complications|The incidence of overall 30-day postoperative complications will be recorded. These are defined in the MSKCC Adverse Events Program and organized by categories reflecting organ systems and further subdivided into specific complications within those and graded.|30 days post procedure||||Participants|||Count of Participants
2658585|NCT01597245|Secondary|Percentage of Participants With Anti-Ixekizumab Antibodies|Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the # of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.|Baseline to Week 12|All randomized participants who received at least 1 dose of study treatment and had evaluable data.|||percentage of participants|||Number
2658586|NCT01597245|Secondary|Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75) or 100% (PPASI100) Improvement|The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 to 72. The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. Participants achieving PPASI50, PPASI75 or PASI100 were defined as having an improvement of at least 50%, 75%, or of 100%, respectively, in the PPASI scores compared to baseline.|Week 12|All randomized participants analyzed according to the treatment to which they are assigned; and who had palmoplantar Ps involvement at baseline. Participants who did not meet clinical response criteria or have missing data will be considered non-responders.|||percentage of participants|||Number
2658587|NCT01597245|Secondary|Change From Baseline in Patient's Global Assessment (PatGA) of Disease Severity|"The Patient's Global Assessment of Disease Severity is a single-item patient reported outcome measure on which participants are asked to rate by circling a number on a 0 to 5 NRS the severity of their psoriasis today from 0 (Clear) = no psoriasis to 5 (Severe) = the worst their psoriasis has ever been. LS mean change from baseline in patient's global assessment of disease severity score was calculated using (MMRM) with baseline score as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects."|Baseline, 12 weeks|All randomized participants analyzed according to the treatment to which they are assigned, and had baseline and at least 1 post baseline PatGA measurement.|||units on a scale||Standard Error|Least Squares Mean
2658588|NCT01597245|Secondary|Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores|The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean change from baseline in SF-36 score was calculated using the ANCOVA model with treatment, pooled center and baseline SF-36 score.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned, and had baseline and at least 1 post baseline SF-36 measurement. Missing data was imputed by last observation carried forward ( LOCF ).|||units on a scale||Standard Error|Least Squares Mean
2658589|NCT01597245|Secondary|Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO)|The (WPAI-PSO) is a 6-item instrument used to assess the impact of psoriasis on productivity impairment within the past 7 days and has four domains, namely, absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score, and impairment in daily activities performed outside of work. Four scores are derived as percentages: absenteeism, presenteeism, overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as each score * 100 and ranges from 0 to 100; greater scores indicate greater impairment. LS mean change from baseline in each WPAI-PSO score was calculated using the (ANCOVA) model with treatment, pooled center and baseline WPAI value.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned, and had baseline and at least 1 post baseline WPAI-PSO measurement. Missing data was imputed by last observation carried forward ( LOCF ).|||units on a scale||Standard Error|Least Squares Mean
2658590|NCT01597245|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score|The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual depression domains (sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance [initial, middle and late insomnia or hypersomnia], decrease/increase in appetite/weight, and psychomotor agitation/retardation), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. LS mean change from baseline in total QIDS-SR16 score was calculated using the analysis of covariance (ANCOVA) model with treatment, pooled center and baseline QIDS total score.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned, and had baseline and at least 1 post baseline QIDS-SR16 measurement. Missing data was imputed by last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2658591|NCT01597245|Secondary|Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis|The percentage involvement of psoriasis on each participant's body surface area was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb. LS mean change from baseline in BSA was calculated using MMRM with baseline BSA as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned; and had at least 1 post-baseline BSA measurement.|||units on a scale||Standard Error|Least Squares Mean
2658599|NCT01597245|Secondary|Percentage of Participants Achieving an sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [sPGA])|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 12|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
2658592|NCT01597245|Secondary|Change From Baseline Psoriasis Scalp Severity Index (PSSI) Score|The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 (less severity) to 72 (more severity), with lower scores indicating less severity. LS mean change from baseline in PSSI score was calculated using MMRM with baseline score as a covariate, treatment, pooled center, visit, and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned; and had scalp Ps involvement at baseline and at least 1 post-baseline PSSI measurement. Missing data was imputed by last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2658593|NCT01597245|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps. The fingernail bed and fingernail matrix are each divided into quadrants. Each fingernail is given a score for fingernail bed Ps and fingernail matrix Ps, each with scores of 0 (none) to 4 (Ps in all 4 quadrants), depending on the presence (score of 1) or absence (score of 0) of Ps in each quadrant of the fingernail bed or matrix. The NAPSI score of a fingernail is the sum of scores from each quadrant of the fingernail bed and fingernail matrix (maximum of 8). The total NAPSI score equals the sum of all fingernails and ranges from 0 to 80 with higher scores indicating more severe Ps. LS mean change from baseline in NAPSI score was calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned; and had fingernail Ps involvement at baseline and at least 1 post-baseline NAPSI measurement.|||units on a scale||Standard Error|Least Squares Mean
2658594|NCT01597245|Secondary|Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Total Score (Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes [PRO])|"DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much); and not relevant and unanswered responses were scored as 0. Total scores range from 0 to 30, with higher score indicating greater quality of life impairment. A 5-point change from baseline is considered clinically relevant. Least Squares (LS) Mean change from baseline was calculated using mixed model repeated measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects."|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned and who had baseline and at least 1 post-baseline DLQI measurement.|||units on a scale||Standard Error|Least Squares Mean
2658595|NCT01597245|Secondary|Percentage of Participants With Itching Severity (Itch Numeric Rating Scale [NRI]) Score ≥4 Point Reduction From Baseline|"The Itch Numeric Rating Scale (NRS) is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. The number and percentage of participants achieving an Itch NRS ≥4 point reduction from baseline were presented by treatment group for participants who had a baseline Itch NRS ≥4. Describes worst level of itching in past 24 hours."|Baseline, Week 12|All randomized participants analyzed according to the treatment to which they are assigned and had Itch NRS ≥4 at baseline. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.|||percentage of participants|||Number
2658596|NCT01597245|Secondary|Percentage of Participants Maintaining an sPGA (0,1) From Week 12 After Re-randomization at Start of Maintenance Dosing Period to Week 60|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 60|All randomized participants who had sPGA score of (0,1) at Week 12, were re-randomized at Week 12 and received at least 1 dose of study treatment in the Maintenance Dosing Period. Participants who did not meet the clinical response criteria or had missing data at Week 60 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||Percentage of participants|||Number
2658597|NCT01597245|Secondary|Percentage of Participants Achieving PASI 100% (PASI100)|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI100 were defined as having an improvement of 100% in the PASI score compared to baseline.|Week 12|All randomized participants analyzed according to the treatment to which they are assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.|||percentage of participants|||Number
2658598|NCT01597245|Secondary|Percentage of Participants Achieving PASI 90% (PASI90) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: [PASI])|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI90 were defined as having an improvement of ≥90% in the PASI score compared to baseline.|Week 12|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
2658600|NCT01597245|Primary|Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) ≥75% (PASI75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor (head [0.1], upper limbs [0.2], trunk [0.3], lower limbs [0.4]). Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.|Week 12|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
2658601|NCT01597245|Primary|Percentage of Participants With a Static Physician Global Assessment (sPGA) of (0,1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])|"The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline."|Week 12|All randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
2658602|NCT01597193|Secondary|Dose-Expansion Phase: Trough Plasma Concentration for Enzalutamide||pre-dose on Day 57|PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.|||micrograms per milliliter||Standard Deviation|Mean
2658603|NCT01597193|Primary|Dose-Escalation Phase: Accumulation Ratio of AUC24 of Enzalutamide and Its Metabolites After Multiple Dosing|Accumulation Ratio was defined as the ratio of AUC24 of Day 50 to AUC24 of Day 1, where AUC24 was area under the plasma concentration-time curve from time zero to 24 hours post-dose. Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.|pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 1 and 50|PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||ratio||Standard Deviation|Mean
2658604|NCT01597193|Primary|Dose-Escalation Phase: Peak-to-Trough Ratio of Enzalutamide and Its Metabolites After Multiple Dosing|Peak-to-trough ratio was calculated by dividing Cmax with Cmin of Enzalutamide and its Metabolites. Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide. Cmax was maximum plasma concentration during the dosing interval and Cmin was minimum observed plasma concentration during the dosing interval.|pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50|PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||ratio||Standard Deviation|Mean
2658605|NCT01597193|Primary|Dose-Escalation Phase: Apparent Oral Clearance (CL/F) of Enzalutamide After Multiple Dosing|Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50|PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||liter per hour||Standard Deviation|Mean
2658606|NCT01597193|Primary|Dose-Escalation Phase: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Enzalutamide and Its Metabolites After Multiple Dosing|Area under the plasma concentration versus time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours. Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.|pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50|PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||milligram*hour per milliliter||Standard Deviation|Mean
2658607|NCT01597193|Primary|Dose-Escalation Phase: Time to Reach Maximum Plasma Concentration (Tmax) of Enzalutamide and Its Metabolites After Multiple Dosing|Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.|pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50|PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||hours||Full Range|Median
2658608|NCT01597193|Primary|Dose-Escalation Phase: Maximum Plasma Concentration (Cmax) of Enzalutamide and Its Metabolites After Multiple Dosing|Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.|pre-dose, 0.5, 1, 2, 4, 6, and 24 hours post-dose on Day 50|PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||micrograms per milliliter||Standard Deviation|Mean
2658637|NCT01596972|Secondary|Patient Compliance With Each Follow-up Method||2 weeks||||participants|||Number
2659091|NCT01591681|Secondary|Percent of Mornings With Urine Ketones >/= 15 mg/dl|Urine ketones measured each morning with Ketostix.|42 mornings following night of system use||||percentage of mornings|Participants||Number
2658609|NCT01597193|Primary|Dose Escalation Phase: Apparent Volume of Distribution (Vz/F) of Enzalutamide After Single Dosing|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1|PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.|||liter||Standard Deviation|Mean
2658610|NCT01597193|Primary|Dose Escalation Phase: Apparent Oral Clearance (CL/F) of Enzalutamide After Single Dosing|Apparent oral clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. It was obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.|pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1|PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.|||liter per hour||Standard Deviation|Mean
2658611|NCT01597193|Primary|Dose-Escalation Phase: Terminal Elimination Half-Life (t1/2) of Enzalutamide After Single Dosing|Terminal elimination half-life is the time measured for the plasma concentration of Enzalutamide to decrease by one-half of its initial concentration.|pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1|PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Standard Deviation|Mean
2658612|NCT01597193|Primary|Dose-Escalation Phase: Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Enzalutamide After Single Dosing|AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf).|pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1|PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.|||micrograms*hour per milliliter||Standard Deviation|Mean
2658613|NCT01597193|Primary|Dose-Escalation Phase: Area Under the Plasma Concentration-time Curve From Time Zero to 72 Hours (AUC72h) of Enzalutamide After Single Dosing||pre-dose, 0.5, 1, 2, 4, 6, 24, 48 and 72 hours post dose on Day 1|PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.|||micrograms*hour per milliliter||Standard Deviation|Mean
2658614|NCT01597193|Primary|Dose-Escalation Phase: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC24h) of Enzalutamide and Its Metabolites After Single Dose|Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.|pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post dose on Day 1|PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.|||micrograms*hour per milliliter||Standard Deviation|Mean
2658615|NCT01597193|Primary|Dose-Escalation Phase: Time to Reach Maximum Plasma Concentration (Tmax) of Enzalutamide and Its Metabolites After Single Dosing|Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.|pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1|PK analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.|||hours||Full Range|Median
2658616|NCT01597193|Primary|Dose-Escalation Phase: Maximum Plasma Concentration (Cmax) of Enzalutamide and Its Metabolites After Single Dose|Carboxylic Acid (M1) and N-desmethyl (M2) are two metabolites of Enzalutamide.|pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72 and 96 hours post dose on Day 1|Pharmacokinetic (PK) analysis population included all participants who had at least 1 dose of Enzalutamide and had sufficient PK data to calculate at least 1 of the PK parameters of interest in at least 1 treatment period.|||micrograms per milliliter||Standard Deviation|Mean
2658617|NCT01597193|Primary|Percentage of Participants With Potentially Clinically Significant Change From Baseline in Vital Signs|Absolute systolic blood pressure (SBP) greater than (>) 180 millimeter of mercury (mm Hg) and an increase of >40 mm Hg from baseline; absolute SBP less than (<) 90 mm Hg and an decrease of >30 mm Hg from baseline. Absolute diastolic blood pressure (DBP) >105 mm Hg and an increase of >30 mm Hg from baseline; absolute DBP <50 mm Hg and an increase of >20 mm Hg from baseline. Absolute heart rate >120 beats per minute (bpm) and an increase of >30 bpm from baseline; absolute heart rate <50 bpm and decrease of >20 bpm from baseline. Participants with any of these abnormalities were reported for this outcome in each arm.|Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)|Safety analysis population included all enrolled participants who received at least 1 dose of Enzalutamide.|||percentage of participants|||Number
2658618|NCT01597193|Primary|Percentage of Participants Who Require Dose Reductions Due to Adverse Events|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.|Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)|Safety analysis population included all enrolled participants who received at least 1 dose of Enzalutamide.|||percentage of participants|||Number
2658619|NCT01597193|Primary|Percentage of Participants Who Discontinued the Study Drug Due to Adverse Events or Serious Adverse Events|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.|Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)|Safety analysis population included all enrolled participants who received at least 1 dose of Enzalutamide.|||percentage of participants|||Number
2658620|NCT01597193|Primary|Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)|Safety analysis population included all enrolled participants who received at least 1 dose of Enzalutamide.|||percentage of participants|||Number
2658621|NCT01597193|Primary|Percentage of Participants With Adverse Events of Grade 3 or Higher Severity by National Cancer Institute Common Toxicity Criteria For Adverse Events (NCI CTCAE) (Version 4.03)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on NCI CTCAE Version 4.03 and defined as Grade 3 AEs = severe or medically significant events but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care activities of daily living; Grade 4 AEs = life-threatening, urgent intervention indicated; Grade 5 AEs = death related to adverse event.|Day 1 up to 30 days after the last dose of study drug or before initiation of a new systemic antitumor treatment, whichever occurred first (up to 3.5 years)|Safety analysis population included all enrolled participants who received at least 1 dose of Enzalutamide.|||percentage of participants|||Number
2658622|NCT01597193|Primary|Dose-Escalation Phase: Percentage of Participants With Dose-limiting Toxicity (DLTs)|DLTs were defined as any of following events related to the study drug: Any adverse event (AE) consistent with a seizure of any grade; Grade greater than equal to (>=) 3 fatigue, diarrhea, nausea, or vomiting that did not improve to Grade 1 within 14 days of initiating standard of care therapy; any Grade >=3 hematologic toxicity with the following modifications: 1) Grade >=3 platelet count associated with bleeding, 2) Grade >=3 absolute neutrophil count that persists for 7 or more days or that was associated with fevers (febrile neutropenia); Grade >=3 any other non-hematological toxicity that was determined to be related to study drug.|Baseline up to Day 35|Safety analysis population included all enrolled participants who received at least 1 dose of Enzalutamide. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2658623|NCT01597141|Secondary|Functioning|Global Assessment of Functioning scale (GAF) at 24 months to assess functioning in symptom, role and social relationships. Global Assessment of Functioning is a widely used scale based on a Likert-keyed score assigned by an interviewer or clinician, based on a scale of 0-100, with 100 being the highest level of functioning.|24 months|15 participants in the FACT arm and 16 participants in the Enhanced Standard Treatment arm were not assessed, having discontinued participation in the study.|||units on GAF scale||Standard Deviation|Mean
2658624|NCT01597141|Primary|Onset of Psychosis|Onset of psychosis is defined as an event--a new psychotic episode with loss of insight, meeting a score criterion of 6 for one month on the Scale of the Prodromal Syndrome (SOPS), in which full psychosis is defined as havng one score or 6, on a scale of 0 to 6, with 0 representing no psychotic symptoms, and 6 representing full psychosis on any of 5 dimensions of psychosis. The assessemnt is based on the Structrued Interview for the Prodromal Syndrome (SIPS), w widely used instrument for assessing risk of psychosis in adolescents and young adults.|From date of randomization until the date of first documented onset of psychosis, assessed up to 60 months||||percentage of sample converting|||Number
2658625|NCT01597128|Primary|Change in SF12 Mental Component Score Between Pre-operation and 12 Months Post-operation|Change in SF12 Mental Component Score from pre-operation to 12 months post-operation: Scores were normalized with 50 equal to the national norm and 40 equal to one standard deviation below the norm; An increase is better.|12 months|Patients with 12 month completion of the SF12|||Normalized scores||Standard Deviation|Mean
2658626|NCT01597128|Primary|Change in SF12 Physical Component Score Between Pre-operation and 12 Months Post-operation|Change in SF12 Physical Component Score from pre-operation to 12 months post-operation: Scores were normalized with 50 equal to the national norm and 40 equal to one standard deviation below the norm, so a 12 month difference of 10 would equal a 1 standard deviation change; An increase is better.|12 months|Patients with 12 month completion of the SF12|||Normalized scores||Standard Deviation|Mean
2658627|NCT01597128|Primary|Wound Occurrence: Superficial Wound Infection|Superficial wound infection|12 months||||percent of patients|||Number
2658628|NCT01597128|Primary|Wound Occurrence: Wound Dehiscence||12 Months||||percentage of patients|||Number
2658629|NCT01597128|Primary|Wound Occurrence: Wound Cellulitis||12 Months||||percentage of patients|||Number
2658630|NCT01597128|Primary|Wound Occurrence: Wound Seroma||12 Months||||percentage of patients|||Number
2658631|NCT01597128|Primary|Wound Occurrence: Wound Abscess||12 Months||||percentage of patients|||Number
2658632|NCT01597128|Primary|Wound Occurrence: Deep Wound Infection||12 Months||||percentage of patients|||Number
2658633|NCT01597128|Primary|Wound Occurrence|superficial or deep wound infection, abscess, seroma, cellulitis, necrosis, hematoma or wound dehiscence.|12 months||||percentage of patients|||Number
2658634|NCT01597128|Primary|Hernia Recurrence|Recurrence of hernia based on physical exam and /or CT scan.|12 months||||percentage of patients|||Number
2658635|NCT01597050|Primary|Decrease in the Total Combined Erythema and Scaling Score (Minimum of 0 and Maximum of 65) of All Treated Lesions.|Percentage of patients who achieved at least a 50% decrease from baseline in the total combined Erythema and Scaling score of all treated lesions at Week 4. A decrease is an improvement in measurement of erythema and scaling of the lesions.|Up to Week 4|Per-protocol population all patients who had no major protocol deviations and were present at all scheduled visits up to and including Week 4.|||percentage of subjects|||Number
2658636|NCT01596972|Secondary|Patient Satisfaction With Each Follow-up Method|"Patient satisfaction with each follow-up method was assessed with the following survey questions:~How satisfied are you with [name of follow-up method]? (very satisfied, satisfied, neutral, unsatisfied, very unsatisfied)"|1 week||||participants|||Number
2658638|NCT01596972|Primary|Number of Women in Each Group Who Require a Return Visit to the Clinic for a Serum hCG Measurement, Ultrasound or Clinical Examination at One Week to Confirm Complete Evacuation||1 week|The number of participants analyzed in the serum hCG arm were the number of participants who started in this arm minus the number who were discontinued from the study per MD decision (total N in analysis was therefore 17).|||participants|||Number
2658639|NCT01596842|Secondary|Changes of Phosphate Binder Doses||4 weeks, 8 weeks and 12 weeks|||||||
2658640|NCT01596842|Secondary|Changes of Erythropoietin Doses||4 weeks, 8 weeks and 12 weeks|||||||
2658641|NCT01596842|Secondary|Changes of Phosphorous Levels||4 weeks, 8 weeks and 12 weeks|||||||
2658642|NCT01596842|Secondary|Change of FGF-23 Levels||12 weeks|||||||
2658643|NCT01596842|Secondary|Change of Fetuin-A Levels||12 weeks|||||||
2658644|NCT01596842|Secondary|Change of Intact Parathyroid Hormone||12 weeks|||||||
2658645|NCT01596842|Secondary|Changes of Calcium Levels||4 weeks, 8 weeks and 12 weeks|||||||
2658646|NCT01596842|Secondary|Hemoglobin Levels at 12 Weeks||12 weeks||||g/dL||Standard Deviation|Mean
2658647|NCT01596842|Primary|25-hydroxyvitamin D Levels at 12 Weeks||12 weeks||||ng/ml||Standard Deviation|Mean
2658648|NCT01596699|Secondary|Serum Concentrations and Potential for Drug-drug Interaction of Fludarabine and Clofarabine|Fludarabine and clofarabine drug levels and potential covariates influencing drug exposure such as renal function and genetic variants involved in drug metabolism, distribution, and activation will be analyzed using standard population pharmacokinetic methods using non-linear mixed effects modeling (NONMEM) software|Pharmacokinetics (PK) blood sampling Days -5 to -2 pre-hematopoietic stem cell transplant.|PK Data not collected||||||
2658649|NCT01596699|Secondary|Mixed-donor Chimerism Rate of Patients With High-risk Myeloid Malignancies (Stratum B)|Full-donor chimerism will be defined by as ≥99% donor cells by Short Tandem Repeat (STR) analysis in all cell lines (CD3, CD14/15, and CD19) in peripheral blood. The historic control for Stratum B was determined using the 20 patients who were transplanted from 2005 - 2010 with Busulfan (BU)-based regimens and who retrospectively would have been eligible for the current trial. Of these 20 patients, at 100 days post-HCT, only 8 (40%) patients had full-donor chimerism. If 5 patients in Stratum B experienced mixed-donor chimerism at Day 100, we will close this stratum early for failing to achieve superior donor cell engraftment compared to standard-of-care.|Participants will have peripheral blood chimerism assessed at Day 100 post hematopoietic stem cell transplant and then monthly until stable.||||percentage of participants|||Number
2658650|NCT01596699|Secondary|Engraftment Rate of Patients With Non-malignant Diseases (Stratum A)|Engraftment will be defined as the development of an Absolute Neutrophil Count (ANC) >500 for 3 consecutive days plus donor CD14/15 cells >70%. The engraftment rate in the population used for historical control is 40%. If 3 patients in Stratum A experience graft rejection, this stratum will close early for failing to achieve superior engraftment compared to standard-of-care.|Participants will have engraftment blood studies starting approximately Day 30 post hematopoietic stem cell transplant and then monthly until stable. Average study participation is approximately 5 years.|Three patients in Stratum A experienced graft rejection which met the criteria for failing to achieve superior engraftment compared to standard-of-care. One patient was not evaluable.|||percentage of participants|||Number
2658651|NCT01596699|Primary|Number of Participants With Treatment-Related Adverse Events as a Measure of Safety and Tolerability|Severe Toxicity will be defined as death or Grade IV by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 pulmonary or hepatic failure (including moderate veno-occlusive disease(VOD) related to the transplant conditioning regimen within 100 days post-HCT. VOD will be defined by standard criteria. Patients must have Bilirubin >2.0 plus Hepatomegaly and/or Right upper quadrant (RUQ) pain plus Weight gain >5%.|Up to 5 years on average||||participants|||Number
2658652|NCT01596582|Other Pre-specified|Concordance Between Patient Preferences for a Screening Tests Other Than Colonoscopy and Test Ordered for High Versus Low Risk Patients|Test-specific concordance between patient preference for a screening test other than colonoscopy (fecal occult blood testing, flexible sigmoidoscopy, double-contrast barium enema, CT colonography and stool DNA) and test ordered for high versus low risk patients. It is defined as the number of patients who had their preferred test ordered.|3 months||||Participants|||Count of Participants
2658653|NCT01596582|Other Pre-specified|Concordance Between Patient Preference for Colonoscopy and Test Ordered for High Versus Low Risk Patients|Test-specific concordance between patient preference for colonoscopy and test ordered for high versus low risk patients. It is defined as the number of patients who had their preferred test ordered.|3 months||||Participants|||Count of Participants
2658654|NCT01596582|Other Pre-specified|Concordance Between Patient Preferences for Screening Tests Other Than Colonoscopy and Test Ordered|Test-specific concordance between patient preference for a screening test other than colonoscopy (fecal occult blood testing, flexible sigmoidoscopy, double-contrast barium enema, CT colonography and stool DNA) and test ordered for standard care versus risk assessment arms. It is defined as the number of patients who had their preferred test ordered.|3 months||||Participants|||Count of Participants
2658655|NCT01596582|Other Pre-specified|Concordance Between Patient Preference for Colonoscopy and Test Ordered|Test-specific concordance between patient preference for colonoscopy and test ordered for standard care versus risk assessment groups. It is defined as the number of patients who had their preferred test ordered.|3 months||||Participants|||Count of Participants
2658656|NCT01596582|Secondary|Provider Satisfaction|"Provider satisfaction was assessed based on responses to a 3-item pretest administered prior to commencement of the study and the same 3-item posttest. The 3 items assessed to the extent to which providers felt that personalized risk assessment would be useful for: (1) selecting an appropriate screening test for their average risk patients [test selection]; (2) reduce time to decide on an appropriate screening modality [save time]; and (3) make them more receptive to patient preferences and possibly order a screening test other than colonoscopy [receptive to patient preferences]. Responses were assigned a point value ranging from 5= strongly agree and 1 = strongly disagree."|Two years|The difference in the number of providers reflect provider attrition during the 2-year study period.|||units on a scale||Standard Deviation|Mean
2658657|NCT01596582|Secondary|Screening Test Completion|Test completion rates were tracked using BMC's electronic medical record, which captures results for all endoscopic procedures, imaging studies, and stool blood tests.|6 months||||Participants|||Count of Participants
2658658|NCT01596582|Secondary|Screening Intentions|Screening intentions were assessed on the posttest. Patients were asked how sure they were that they would complete the screening test that got scheduled Scores ranged from 5 = ''completely'' to 1 = ''not at all sure.'' Data was missing for 11 patients in the concordant group and 6 patients in the discordant group.|3 months||||units on a scale||Standard Deviation|Mean
2658659|NCT01596582|Secondary|Satisfaction With Decision-making Process (SDMP)|SDMP was assessed on the posttest using the validated 12-item Satisfaction with the Decision-Making Process scale. Individual items are assigned a point value ranging from 1 for ''strongly disagree'' (or ''poor'') to 5 for ''strongly agree'' (or ''excellent''). A cumulative score is then calculated based on the summed response scores for each item (maximum score = 60). Data was missing for 11 patients in the concordant group and 6 patients in the discordant group|One month|The subgroup of patients who had their preferred test ordered, regardless of study arm or risk-category. The subgroup of patients who had a non-preferred test ordered, regardless of study arm or risk-category.|||units on a scale||Standard Deviation|Mean
2658660|NCT01596582|Secondary|Concordance Between Patient Preference and Test Ordered for High vs. Low Risk Patients|Concordance between patient preference and test ordered for high versus low risk patients. It is defined as the number of patients who had their preferred test ordered.|3 months|Patients with cumulative ACNI scores of 5 to 12 were classified as intermediate/high risk (hereafter referred to as high risk), with a mean ACN rate of 8.3% (95% CI, 7.1% - 29.6%). Patients with cumulative scores of less than 5 were classified as low risk, with a mean ACN rate of 3.1% (95% confidence interval [CI], 2.4% - 24.1%).|||Participants|||Count of Participants
2658661|NCT01596582|Primary|Concordance Between Patient Preference and Test Ordered|Concordance is a measure of the agreement between the patient's test preference and actual test ordered for standard care vs. risk assessment patients. It is defined as the number of patients who had their preferred test ordered.|3 months||||Participants|||Count of Participants
2658662|NCT01596504|Secondary|Change From Baseline to Day 56 in the Cumulative Score Mean on the Appetite Perception Using a Visual Analogue Scale After Standardized Solid Breakfast|Visual Analogue Scale, 100 mm in length with words anchored at each end, expressing the most positive (100 mm) and the most negative rating (0 mm), was used to assess hunger, satiety, fullness and prospective food consumption. Responses were measured as distance from the left end of the line to the mark. Mean change from baseline was calculated for each parameter separately.|0.5 (8:00 clock time, prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours on Day -3; 0 (prior to standardized breakfast), 1.5, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed=participants with appetite perception assessment at specified time-points.|||mm||Standard Deviation|Mean
2658663|NCT01596504|Secondary|Change From Baseline to Day 57 in Waist Circumference||0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to IMP administration on Day 57|PD population. Number of participants analyzed = participants with waist circumference assessment at specified time-points.|||cm||Standard Deviation|Mean
2658664|NCT01596504|Secondary|Change From Baseline to Day 57 in Body Weight||0.5 hours prior to standardized breakfast on Day -1 (Baseline); 0.5 hours prior to study drug administration on Day 57|PD population. Number of participants analyzed = participants with body weight assessment at specified time-points.|||kg||Standard Error|Least Squares Mean
2658665|NCT01596504|Secondary|Change From Baseline to Day 57/58 in 24-Hour Mean Systolic Blood Pressure and Diastolic Blood Pressure|The baseline value was the 24-hour means on Day -2/-1 determined as overall, night and day-time mean. Measurements were made every 15 minutes from 07:00 to 23:00 (day-time) and every 30 minutes from 23:00 to 07:00 (night-time) at baseline and at Day 57/58. Measurements were obtained after 10 minutes in the supine resting position.|Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/ -1 (Baseline) and Day 57/58|PD population. Number of participants analyzed = participants with blood pressure assessment at specified time-points.|||mmHg||Standard Deviation|Mean
2658666|NCT01596504|Secondary|Change From Baseline to Day 57/58 in 24-Hour Mean Heart Rate|The baseline value was the 24-hour mean on Day -2/-1 determined as overall, night and daytime mean. Measurements were made every 15 minutes from 07:00 to 23:00 (daytime) and every 30 minutes from 23:00 to 07:00 (night-time) at baseline and Day 57/58. Measurements were obtained after 10 minutes in the supine resting position.|Every 15 minutes from 07:00 clock time to 23:00 clock time (day-time) and every 30 minutes from 23:00 clock time to 07:00 clock time (night-time) on Day -2/-1 (Baseline) and Day 57/58|PD population. Number of participants analyzed = participants with heart rate assessment at specified time-points.|||beats per minute||Standard Error|Least Squares Mean
2658667|NCT01596504|Secondary|Change From Baseline to Day 55 in Gastric Emptying Coefficient|Gastric emptying was measured using 13C-octanoic acid breath test by isotope-selective non-dispersive infrared spectrometry. Gastric emptying coefficient was derived from a mathematical formula that describes the gastric emptying rate and gives an overall index of gastric emptying.|0 (7:30 clock time, prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55|PD population. Number of participants analyzed = participants with gastric emptying at specified time-points.|||coefficient (unit-less)||Standard Deviation|Mean
2658668|NCT01596504|Secondary|Change From Baseline to Day 55 in Gastric Emptying Half Life (t1/2)|Gastric emptying was measured using 13C-octanoic acid breath test by isotope-selective non-dispersive infrared spectrometry.|0 (prior to standardized breakfast), 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 3.5, 4, 4.5, 5, 5.5 hours on Day -4 (baseline) and on Day 55|PD population. Number of participants analyzed=participants with gastric emptying assessment at specified time-points.|||minutes (min)||Standard Error|Least Squares Mean
2658669|NCT01596504|Secondary|Change From Baseline to Day 56 in Average Daily Insulin Glargine Dose||Day -7 (Baseline), Day 56|PD population. Number of participants analyzed=participants with insulin glargine dose assessment at specified time-points.|||units||Standard Deviation|Mean
2658670|NCT01596504|Secondary|Change From Baseline to Day 56 in HbA1c|HbA1C was assessed using the high performance liquid chromatography method.|Pre-dose (Hour 0) on Day 1 (Baseline) and Day 56|Number of participants analyzed = participants with HbA1c assessment at specified time-points.|||percentage of HbA1c||Standard Error|Least Squares Mean
2658684|NCT01596283|Secondary|Total Volume of Fluid Used Perioperatively|Assess the impact of GDT compared to standard fluid therapy on the total volume of fluid given intraoperatively|Up to the first 72 hours postoperatively||||liter||Standard Deviation|Mean
2658671|NCT01596504|Secondary|Change From Baseline to Day 56 in Corrected Glucagon AUC From Time 0.5 Hours to 5.5 Hours|Glucagon was assessed using the radioimmunoassay. The range of the method was 4.7 to 150 picomole per litre (pmol/L). Measurement was done on Day -3 (Baseline) and Day 56 as the maximum change in glucagon from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration.|0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed = participants with glucagon assessment at specified time-points.|||h*ng/L||Standard Error|Least Squares Mean
2658672|NCT01596504|Secondary|Change From Baseline to Day 56 in Corrected C-Peptide AUC From Time 0.5 Hours to 5.5 Hours|C-peptide was assessed using the Electro Chemiluminescence Immuno Assay.The range of the method was 0.2 to 25 nanogram per millilitre (ng/mL) and the LOD was 0.07 ng/mL. Measurement was done on Day -3 (Baseline) and Day 56 as the maximum change in C-peptide from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration.|0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day-3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed = participants with C-peptide assessment at specified time-points.|||h*nmol/L||Standard Error|Least Squares Mean
2658673|NCT01596504|Secondary|Change From Baseline to Day 56 in Average 7-Point Self-Monitored Plasma Glucose (SMPG)|Seven-point SMPG (before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime) was measured using Freestyle Precision glucometer and average of the 7 measurements was calculated.|Before breakfast, 2 hours post breakfast, before lunch, 2 hours post lunch, before dinner, 2 hours post dinner, and at bedtime on Day -3 (Baseline) and on Day 56|PD population. Number of participants analyzed = participants with 7 point SMPG assessment at specified time-points.|||mmol/L||Standard Deviation|Mean
2658674|NCT01596504|Secondary|Change From Baseline to Day 56 in Fasting Plasma Glucose (FPG)|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. The value of FPG on Day -3 was the baseline.|0.5 hour (prior to standardized breakfast) on Day -3; 0.5 hour (prior to standardized breakfast) on Day 56|PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.|||mmol/L||Standard Error|Least Squares Mean
2658675|NCT01596504|Secondary|Change From Baseline to Day 56 in PPG Excursion|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. PPG excursion was determined on Day -3 (Baseline) and Day 56 as the maximum change in PPG from time of breakfast start (time: 0.5 hours) until 5 hours later (time: 5.5 hours) subtracted from pre-meal plasma concentration.|0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.|||mmol/L||Standard Error|Least Squares Mean
2658676|NCT01596504|Secondary|Number of Participants With 2-Hour Post-prandial Plasma Glucose (PPG) <7.77 (mmol/L) at Day 56|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as LOD. The 2-hour PPG test measured blood glucose 2 hours after start of a standardised breakfast.|Day 56|PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.|||participants|||Number
2658677|NCT01596504|Secondary|Change From Baseline to Day 56 in Plasma Glucose Corrected AUC From Time 0.5 Hours to 5.5 Hours|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 mg/dL with 1 mg/dL as limit of detection (LOD). Calculation of the AUC was made on Day -3 (baseline) and on Day 56 using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours]) to 5 hours after breakfast start (time: 5.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours).|0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5, 5.5 hours post study drug administration on Day 56|PD population. Number of participants analyzed = participants with plasma glucose assessment at specified time-points.|||h*mmol/L||Standard Error|Least Squares Mean
2658678|NCT01596504|Primary|Change From Baseline to Day 56 in Plasma Glucose Corrected Area Under The Plasma Concentration-Time Curve (AUC) From Time 0.5 Hours to 4.5 Hours|Plasma glucose was assessed using the Gluco-quant Glucose/hexokinase assay. The range of the method was 3 to 1000 milligram per decilitre (mg/dL) with 1 mg/dL as limit of detection (LOD). Calculation of the AUC was made on Day -3 (baseline) and on Day 56 using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours]) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours).|0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -3 (baseline); 0.5 (prior to standardized breakfast), 0.67, 0.84, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 56|Pharmacodynamic (PD) population defined as all randomized participants, who received at least one dose of lixisenatide 20 μg, liraglutide 1.2 mg or liraglutide 1.8 mg, and had both a baseline assessment and at least one post-baseline assessment of any primary or secondary PD variables, irrespective of compliance with study protocol and procedures.|||h*mmol/L||Standard Error|Least Squares Mean
2658679|NCT01596335|Secondary|Incidence of Coronary Artery Lesions||Day 3, Day 7, Day14, Day 21, Day56|The analysis population is evaluation patients.|||percentage of patients|||Number
2658680|NCT01596335|Secondary|Duration of Fever||Up to Day56||||hour||Inter-Quartile Range|Median
2658681|NCT01596335|Primary|Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration||Up to 48hours||||percentage of patients|||Number
2658682|NCT01596283|Secondary|Postoperative Length of Stay|Assess the impact of GDT compared to standard fluid therapy on net fluid balance for the total admission time|Postoperatively for the total admission time, up to 8 days||||days||Full Range|Median
2658683|NCT01596283|Secondary|Total Volume of Fluid Used Postoperatively|Postoperative fluid volume|Postoperatively for the total admission time, up to 8 days||||liter||Standard Deviation|Mean
2658687|NCT01596231|Primary|Drinking Behaviors|A variety of measures describing the drinking behavior will be analyzed with appropriate parametric tests (t-test, analysis of variance): number of beers consumed, weight and volume consumed, sip analysis (number, interlude), and latency (time to open first and subsequent drinks).|Study end||||beers consumed||Standard Deviation|Mean
2658688|NCT01596127|Secondary|Maximum Tolerated Dose (MTD) of Rituximab|MTD is dose level at which at least 1 of 3 participants experiences a dose-limiting toxicity (DLT). DLTdefined as clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and meeting the NCI common terminology criteria that are CTCAE Grade 3 or 4.|2 weeks|Multiple dose levels were designed with a starting dose of 10 mg per injection followed by 25 mg once safety was established in the first 3 patients treated at the first dose level. The study moved tot he next dose level. Due to lack of response and slow accrual, participants were never treated on the next dose level and the study was terminated||||||
2658689|NCT01596127|Primary|Response Rate|The percentage of participants whose cancer shrinks or disappears after treatment where participants are considered as responding to therapy if the Cerebrospinal fluid (CSF) is without evidence of blast cells after four lumbar punctures with rituximab.|2 weeks||||percentage of Participants|||Number
2658690|NCT01596088|Primary|Adverse Events|Number of participants experienced adverse events|4 weeks||||participants|||Number
2658691|NCT01596062|Secondary|Estimated Glomerular Filtration Rate (eGFR) at Day 8 and Week 24|(MDRDa formula) with imputation by last observation carried forward (LOCF)|Day 8, Week 24|Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.|||mL/min/1.73m^2||Standard Deviation|Mean
2658692|NCT01596062|Secondary|Percentage of Participants With of Treatment Failures|Treatment failure was defined either as a BPAR, a graft loss, a death or a loss to follow-up. An extended treatment failure was also defined including treated borderline lesions, BPAR, graft loss, death or loss to follow-up. Treated borderline lesions were considered as acute rejection by investigators and DMC experts.|Day 84 (Week 12), Week 24|Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.|||Percentage of participants|||Number
2658693|NCT01596062|Secondary|Percentage of Participants With Biopsy Proven Acute Rejection (BPAR) According to Type and Severity|Antibody mediated acute rejection: C4d deposition, presence of circulating antidonor antibody, morphologic evidence of acute tissue injury such as acute tubular necrosis-like minimal inflammation or capillary and/or glomerular inflammation and/or thromboses or arterial inflammation. Cellular acute rejection: acute T-cell mediated rejection Type IA: Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells) Type IB: Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells) Type IIA: Mild to moderate intimal arteritis. Type IIB: Severe intimal arteritis comprising > 25% of the lumenal area. Type III: Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation).|Day 84 (Week 12), Week 24 post-transplantation|Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.|||Percentage of participants|||Number
2658694|NCT01596062|Secondary|Percentage of Participants With of Biopsy Proven Acute Rejection (BPAR)|BPAR is one of the components of treatment failure. One assessment of efficacy was BPAR. Renal graft biopsies were performed and the renal tissue was examined to determine if there was acute rejection of the renal transplant.|Day 84 (Week 12), Week 24 post-transplantation|Intent to treat (ITT) population: All randomized patients having received at least one Simulect® injection and who had been transplanted. This population is the reference population for the efficacy analyses.|||Percentage of participants|||Number
2658695|NCT01596062|Secondary|Proportion of CD3+, CD4+, CD8+, CD19+ and CD56+ T Cells|Cell counts of various subpopulations of T, B and NK lymphocytes (CD3, CD4, CD8, CD19 and CD56) (flow cytometry).|Day 0, Day 6, Day 42, Day 84 (Week 12)|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.|||10^9 cells/L||Standard Deviation|Mean
2658696|NCT01596062|Secondary|Percentage of T-cells That Bind Basiliximab to CD25 Receptors|This is the percentage of T cells binding basiliximab at all timepoints.|Day 0, Day 1, Day 4, Day 6, Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 (Week 12) post-transplantation|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.|||Percentage of T cells||Standard Deviation|Mean
2658697|NCT01596062|Secondary|AUC of Basiliximab Binding to CD25 Receptors From Day 0 to Day 84|Mean AUC was calculated only for patients who received two Simulect injections.|Day 84 (Week 12) post-transplantation|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.|||Weeks * Percentage of T cells||Standard Deviation|Mean
2658698|NCT01596062|Primary|Saturation Rate of CD25 Antigen Saturation by Basiliximab|CD25 saturation is the percentage of T cells expressing CD25|Day 0, Day 1, Day 4, Day 6, Day 14, Day 21, Day 28, Day 42, Day 56 and Day 84 (Week 12) post-transplantation|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.|||percentage of T cells||Standard Deviation|Mean
2658699|NCT01596062|Primary|Area Under the Curve (AUC) of CD25 Saturation by Basiliximab From Day 0 to Day 84|CD25 saturation is the percentage of T cells expressing CD25. Mean AUC of CD25 was calculated only for patients who received two Simulect® injections.|Day 84 (Week 12) after transplantation|PK/PD population: Patients included in the ITT population for whom at least one blood sample for PK/PD analyses was collected. This population is the reference population for the PK and PD analyses.|||Weeks * Percentage of saturated CD25||Standard Deviation|Mean
2658700|NCT01595854|Secondary|Number of Participants With Drug Related Adverse Events|The number of participants with drug related adverse events|From screening until the end-of-study examination|Treated set|||participants|||Number
2658701|NCT01595854|Primary|Total Dabigatran: Maximum Measured Concentration (Cmax)|Maximum measured concentration of total dabigatran in plasma, per period.|-1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours|Pharmacokinetic (PK) set defined as all subjects of Part 3 who received at least 1 dose of trial medication and provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2658702|NCT01595854|Primary|Total Dabigatran (Dabi): Area Under the Curve 0 to Infinity (AUC0-∞)|Area under the concentration-time curve of the analyte in plasma, over the time interval from 0 extrapolated to infinity, of dabigatran.|-1/-0.5, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours|Pharmacokinetic (PK) set defined as all subjects of Part 3 who received at least 1 dose of trial medication and provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of bioavailability.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2658703|NCT01595646|Other Pre-specified|Glucose Tolerance|Subjects will undergo oral glucose tolerance test (OGTT) to assess glucose tolerance|Change from Baseline in Glucose Tolerance at 16 Weeks|||||||
2658704|NCT01595646|Other Pre-specified|Cerebral Blood Flow|Functional MRI and arterial-spin labeling perfusion MRI|Change from Baseline in Cerebral Blood Flow at 16 Weeks|||||||
2658705|NCT01595646|Other Pre-specified|Plasma Biomarkers of AD|Plasma Abeta (ABeta 38, ABeta 40, and Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject.|Change from Baseline in Plasma Biomarkers at 16 Weeks|||||||
2658706|NCT01595646|Other Pre-specified|Executive Function Composite|Sum of Z Scores from Dot Counting Test (test of executive functioning) and Benton Visual Retention Test Form F&G (a test of visual working memory)|Change from Baseline in Executive Functioning at 16 Weeks|||||||
2658707|NCT01595646|Secondary|The Alzheimer's Disease Assessment Scale-Cognitive [ADAS-Cog/Alzheimer's Disease Cooperative Study (ADCS)] - MCI Revision|This cognitive screening measure contains measures of confrontational naming, following commands, constructional praxis, ideational praxis, orientation, and language production and comprehension. Total scores range from 0-70, with higher scores indicating greater cognitive impairment.|Baseline, Month 2 and Month 4||||units on a scale||Standard Deviation|Mean
2658708|NCT01595646|Secondary|Functional Ability|Subjects will have a collateral informant (i.e., spouse or friend) rate the subjects' ability to carry out activities of daily living on the Dementia Severity Rating Scale. The Dementia Severity Rating Scale is made up of sub-scales and the scores from each are summed to produce one score. The scale assess memory, ability to get from place to place, and speech and language each with a range from 0-6; recognition of family members and social and community both having a range from 0-5; orientation of time, orientation to place, ability to make decisions, home activities and responsibilities, and control of urination and bowels each having a range of 0-4; personal care- cleanliness and eating both with a range of 0-3. The total score range is from 0-54 and lower scores denotes better outcomes.|baseline, month 2, and month 4||||units on a scale||Standard Deviation|Mean
2658709|NCT01595646|Secondary|Cerebral Spinal Fluid (CSF) Biomarkers of AD TTau-P181/Abeta42 Ratio|CSF Abeta (ABeta 38, ABeta 40, and Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject. A pre and post ratio of TTau-P181/Abeta42 will be given.|Change from Baseline in CSF Biomarkers at 16 Weeks||||ratio||Standard Deviation|Mean
2658710|NCT01595646|Secondary|Cerebral Spinal Fluid (CSF) Biomarkers of AD|CSF Abeta (Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject.|Change from Baseline in CSF Biomarkers at 16 Weeks||||pg/mL||Standard Deviation|Mean
2658711|NCT01595646|Primary|Verbal Memory Composite|The composite will consist of the sum of Z scores for Delayed Story Recall and Buschke Selective Reminding Test. In the Story Recall test subjects listen to a story containing 44 informational bits that is read once. Subjects will be asked to recall the story immediately after the reading and after a 20-min delay. Credit is awarded for each bit recalled verbatim or accurately paraphrased. The Buschke Selective Reminding Test measures verbal memory through multiple trials of a list learning task. A list of 12 words is audibly presented to the subject, and subjects recall as many words as possible. On subsequent trials, subjects are only told those words they omitted on the previous trial. The procedure continues until the subject recalls all words on two successive trials or to the twelfth trial. After a 30-minute delay, subjects recall as many items as possible. Number of items recalled after the delay will be summed. Higher scores indicate better performance.|Change from Baseline in Verbal Memory at 16 weeks|The study is in data analysis and manuscript write-up.|||Change in Z score memory composite||Standard Error|Mean
2658712|NCT01595516|Primary|Endothelial t-PA Release in Response to BDK and BDK+C Before and After 12 Weeks of Metoprolol Therapy.|Net endothelial release of t-PA antigen in response to BDK and BDK+C was calculated using the following equation: Net Release of t-PA Antigen=(Cv-Ca) x (FBF x [101-hematocrit/100]) where Cv and Ca represent the concentration of t-PA in the vein and artery respectively. A positive difference indicates a net release and a negative difference net uptake. Arterial and venous blood samples are collected simultaneously at baseline and each dose of the drug (BDK) and BDK+Vit C. t-PA concentration were determined by enzyme immunoassay. Hematocrit was measured in triplicate using the standard microhematocrit technique and corrected for trapped plasma volume within the trapped red blood cells.|t-PA release was measured before the 12 week drug intervention and after the 12 week drug intervention.||||ng/100 mL tissue/min||Standard Error|Mean
2658713|NCT01595516|Primary|Endothelial t-PA Release in Response to Bradykinin (BDK) and Bradykinin+Vitamin C (BDK+C) Before and After 12 Weeks of Nebivolol Therapy.|Net endothelial release of t-PA antigen in response to bradykinin (BDK) and bradykinin+vitamin C (BDK+C) was calculated using the following equation: Net Release of t-PA Antigen=(Cv-Ca) x (FBF x [101-hematocrit/100]) where Cv and Ca represent the concentration of t-PA in the vein and artery respectively. A positive difference indicates a net release and a negative difference net uptake. Arterial and venous blood samples are collected simultaneously at baseline and each dose of the drug (BDK) and BDK+Vit C. t-PA concentration were determined by enzyme immunoassay. Hematocrit was measured in triplicate using the standard microhematocrit technique and corrected for trapped plasma volume within the trapped red blood cells.|t-PA release was measured before the 12 week drug intervention and after the 12 week drug intervention.||||ng/100 mL tissue/min||Standard Error|Mean
2659092|NCT01591681|Secondary|Percent of Mornings With Blood Ketones >1.0 mmol/L|Blood ketones measured with a study blood ketone meter.|42 mornings following night of system use||||percentage of mornings|Participants||Number
2658714|NCT01595516|Primary|Endothelial t-PA Release in Response to Bradykinin (BDK) Before and After the 12 Week Intervention|Net endothelial release of t-PA antigen in response to bradykinin (BDK) was calculated using the following equation: Net Release of t-PA Antigen=(Cv-Ca) x (FBF x [101-hematocrit/100]) where Cv and Ca represent the concentration of t-PA in the vein and artery respectively. A positive difference indicates a net release and a negative difference net uptake. Arterial and venous blood samples are collected simultaneously at baseline and each dose of the drug (BDK). t-PA concentration were determined by enzyme immunoassay. Hematocrit was measured in triplicate using the standard microhematocrit technique and corrected for trapped plasma volume within the trapped red blood cells.|t-PA release was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.||||ng/100 mL tissue/min||Standard Error|Mean
2658715|NCT01595516|Primary|Diastolic Blood Pressure||Diastolic blood pressure was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.||||mmHg||Standard Error|Mean
2658716|NCT01595516|Primary|Systolic Blood Pressure||Systolic blood pressure was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.||||mmHg||Standard Error|Mean
2658717|NCT01595516|Primary|Heart Rate|Resting heart rate in the seated position|Heart rate was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.||||bpm||Standard Error|Mean
2658718|NCT01595438|Secondary|Plasma Concentrations for Avibactam Between 300 to 360 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 300 to 360 minutes after dose|PK analysis set (avibactam between 300 to 360 minutes after dose)|||NG/ML||Full Range|Geometric Mean
2658719|NCT01595438|Secondary|Plasma Concentrations for Avibactam Between 30 to 90 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 30 to 90 minutes after dose|PK analysis set (avibactam between 30 to 90 minutes after dose)|||NG/ML||Full Range|Geometric Mean
2658720|NCT01595438|Secondary|Plasma Concentrations for Avibactam Within 15 Minutes Before/After Dose (PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|within 15 minutes before/after dose|PK analysis set (avibactam within 15 minutes before/after dose)|||NG/ML||Full Range|Geometric Mean
2658721|NCT01595438|Secondary|Plasma Concentrations for Ceftazidime Between 300 to 360 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 300 to 360 minutes after dose|PK analysis set (ceftazidime between 300 to 360 minutes after dose)|||NG/ML||Full Range|Geometric Mean
2658722|NCT01595438|Secondary|Plasma Concentrations for Ceftazidime Between 30 to 90 Minutes After Dose(PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|Between 30 to 90 minutes after dose|PK analysis set (ceftazidime between 30 to 90 minutes after dose)|||NG/ML||Full Range|Geometric Mean
2658723|NCT01595438|Secondary|Plasma Concentrations for Ceftazidime Within 15 Minutes Before/After Dose (PK Analysis Set)|Blood samples were taken on Day 3 for ceftazidime (CAZ) and avibactam (AVI) plasma concentration.|within 15 minutes before/after dose|PK analysis set (ceftazidime within 15 minutes before/after dose)|||NG/ML||Full Range|Geometric Mean
2658724|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participant|||Number
2658725|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Extended microbiological evaluable analysis set at TOC (EME at TOC)|||Participant|||Number
2658726|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by Doripenem MIC for Baseline Pathogen (mMITT Analysis Set)|Per pathogen microbiological response at TOC by Doripenem MIC for baseline pathogen in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
2658727|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participant|||Number
2658728|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Extended microbiological evaluable analysis set at TOC (EME at TOC)|||Participant|||Number
2658729|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC by CAZ AVI MIC for Baseline Pathogen (mMITT Analysis Set)|Per pathogen microbiological response at TOC by CAZ-AVI MIC for baseline pathogen in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
2658730|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)|||Participant|||Number
2658731|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participant|||Number
2658732|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set for blood only|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))|||Participant|||Number
2658733|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (Extended ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (EME at LFU)|||Participant|||Number
2658734|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (Extended ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (EME at TOC)|||Participant|||Number
2658735|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (Extended ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set for blood only|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))|||Participant|||Number
2658736|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set for blood only|At LFU visit. LFU visit is 45 to 52 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
2658737|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set for blood only|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
2658738|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Blood Only (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set for blood only|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
2658739|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the ME at LFU analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)|||Participant|||Number
2658740|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participant|||Number
2658741|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the ME at EOT (IV) analysis set|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))|||Participant|||Number
2658742|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (Extended ME at LFU Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the Extended ME at LFU analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (EME at LFU)|||Participant|||Number
2658743|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (Extended ME at TOC Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the Extended ME at TOC analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (EME at TOC)|||Participant|||Number
2658744|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (Extended ME at EOT (IV) Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the Extended ME at EOT (IV) analysis set|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))|||Participant|||Number
2658745|NCT01595438|Secondary|Per-pathogen Microbiological Response at LFU for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the LFU visit in the mMITT analysis set|At LFU visit. LFU visit is 45 to 52 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
2658746|NCT01595438|Secondary|Per-pathogen Microbiological Response at TOC for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the TOC visit in the mMITT analysis set|At TOC visit. TOC visit is 21 to 25 days from Randomization|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
2658747|NCT01595438|Secondary|Per-pathogen Microbiological Response at EOT (IV) for Baseline Pathogen (mMITT Analysis Set)|Number of favorable per-pathogen microbiological responses at the EOT (IV) visit in the mMITT analysis set|At EOT IV visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)|||Participant|||Number
2658748|NCT01595438|Secondary|Time to First Defervescence While on IV Study Therapy (CE at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the CE at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Clinically evaluable analysis set at TOC(CE at TOC)|||Participants|||Number
2658749|NCT01595438|Secondary|Time to First Defervescence While on IV Study Therapy (Extended ME at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the Extended ME at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)|||Participants|||Number
2658750|NCT01595438|Secondary|Time to First Defervescence While on IV Study Therapy (ME at TOC Analysis Set)|Time to first defervescence while on IV study therapy in patients in the ME at TOC analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Microbiological evaluable analysis set at TOC(ME at TOC)|||Participants|||Number
2658751|NCT01595438|Secondary|Time to First Defervescence While on IV Study Therapy (mMITT Analysis Set)|Time to first defervescence while on IV study therapy in patients in the mMITT analysis set who have fever at study entry.|Time to first defervescence is defined as the time (in days) from the first dose of IV study therapy to first absence of fever, which is temperature ≤ 37.8 C in a 24-hour period.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658752|NCT01595438|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)|||Participants|||Number
2658753|NCT01595438|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC(ME at TOC)|||Participants|||Number
2658754|NCT01595438|Secondary|Per-patient Microbiological Response at TOC in Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)|Favorable per-patient microbiological response at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658755|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (Extended ME at TOC Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the Extended ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC(Extended ME at TOC)|||Participants|||Number
2658756|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (ME at TOC Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the ME at TOC analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC(ME at TOC)|||Participants|||Number
2658757|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC for Patients Infected by Ceftazidime-resistant Gram-negative Pathogen (mMITT Analysis Set)|Clinical cure at the TOC visit for patients infected with a ceftazidime resistant pathogen in the mMITT analysis set. Includes patients infected by at least one ceftazidime-resistant Gram-negative pathogen.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658758|NCT01595438|Secondary|Investigator Determined Clinical Response at LFU (CE at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Clinically evaluable analysis set at LFU (CE at LFU)|||Participants|||Number
2658759|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC (CE at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Clinically evaluable analysis set at TOC (CE at TOC)|||Participants|||Number
2658760|NCT01595438|Secondary|Investigator Determined Clinical Response at EOT (IV) (CE at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Clinically evaluable analysis set at EOT (IV) (CE at EOT (IV))|||Participants|||Number
2658761|NCT01595438|Secondary|Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)|||Participants|||Number
2658762|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)|||Participants|||Number
2658839|NCT01594515|Primary|Number (%) of Subjects With Drug Related Adverse Events|Percentage of subjects with drug related adverse events.|From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.|||Percentage of Participants|||Number
2658763|NCT01595438|Secondary|Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (Extended ME at EOT (IV))|||Participants|||Number
2658764|NCT01595438|Secondary|Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)|||Participants|||Number
2658765|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC )|||Participants|||Number
2658766|NCT01595438|Secondary|Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))|||Participants|||Number
2658767|NCT01595438|Secondary|Investigator Determined Clinical Response at LFU (mMITT Analysis Set)|Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658768|NCT01595438|Secondary|Investigator Determined Clinical Response at TOC (mMITT Analysis Set)|Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658769|NCT01595438|Secondary|Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set)|Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response.|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658770|NCT01595438|Secondary|Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Extended microbiological evaluable analysis set at LFU (Extended ME at LFU)|||Participants|||Number
2658771|NCT01595438|Secondary|Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set)|Number of patients with a favorable per patient microbiological response at TOC|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Extended microbiological evaluable analysis set at TOC (Extended ME at TOC)|||Participants|||Number
2658772|NCT01595438|Secondary|Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Extended microbiological evaluable analysis set at EOT (IV) (EME at EOT (IV))|||Participants|||Number
2658773|NCT01595438|Secondary|Per-patient Microbiological Response at LFU (ME at LFU Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological evaluable analysis set at LFU (ME at LFU)|||Participants|||Number
2658774|NCT01595438|Secondary|Per-patient Microbiological Response at TOC (ME at TOC Analysis Set)|Number of patients with a favorable per patient microbiological response at TOC|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological evaluable analysis set at TOC (ME at TOC)|||Participants|||Number
2658775|NCT01595438|Secondary|Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological evaluable analysis set at EOT (IV) (ME at EOT (IV))|||Participants|||Number
2658776|NCT01595438|Secondary|Per-patient Microbiological Response at LFU (mMITT Analysis Set)|Number of patients with a favorable per patient microbiological response at LFU|At LFU visit. LFU visit is 45 to 52 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658777|NCT01595438|Secondary|Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set)|Number of patients with a favorable per-patient microbiological response at EOT (IV)|At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658778|NCT01595438|Primary|Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set.|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658779|NCT01595438|Primary|Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).|At TOC visit. TOC visit is 21 to 25 days from Randomization.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658780|NCT01595438|Primary|Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test|Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)).|At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time.|Microbiological modified intent to treat analysis set (mMITT)|||Participants|||Number
2658781|NCT01595386|Secondary|ACTH Stimulation Test|AdrenoCorticoTropic Hormone stimulation test will be performed at least 24 hours pre-bypass and immediately after successful discontinuation of bypass and compared. These outcomes will be used as a secondary outcome.|24 hours prebypass and 0 hours post-bypass||||microg/dL||Inter-Quartile Range|Median
2658782|NCT01595386|Secondary|Mortality|Subject mortality will in the CICU will be used as a secondary outcome.|Duration of CICU stay, approximately 1 week||||percentage of patients|||Number
2658783|NCT01595386|Secondary|CICU Length of Stay|CICU length of stay will be calculated from the time the subject is admitted to the CICU post-op until they are discharged from the unit. This will be used as a secondary outcome.|approximately 1 week||||hours||Inter-Quartile Range|Median
2658784|NCT01595386|Secondary|Time Until First Extubation|Respiratory values such as duration of intubation will be used as a secondary outcome.|Until discharge from hospital, approximately 2 weeks||||hours||Inter-Quartile Range|Median
2658785|NCT01595386|Secondary|Changes in Baseline Arterial-venous Oxygen Saturation Difference|Respiratory values such as changes in baseline arterial-venous oxygen saturation difference at admission to the pediatric cardiac intensive care unit will be used as a secondary outcome.|admit to the CICU||||percentage of arterial-venous saturation||Inter-Quartile Range|Median
2658786|NCT01595386|Secondary|Fluid Balance|Hemodynamic variable such as total fluid balance within the first 48 hours post-op will be used as a secondary outcome. Fluid balance is a calculation of the overall fluid status for a given time period. The total input (fluid, medications, etc) that are given to a patient during a given time frame (24 hours) minus the total output (urine, stool, drainage, etc. ) that comes out of a patient during a given time frame.|1st 48 hours post-op||||mL/kg||Inter-Quartile Range|Median
2658787|NCT01595386|Secondary|Average Inotrope Score|Average inotrope score over first 48 hours after Cardiac Intensive Care Unit admission was used as a secondary outcome. Inotrope Score is calculated based on the dose of inotropes currently infusing at a given time points. The formula for calculation is as follows: Epinephrine/Norepinephrine (mcg/kg/min) dose x100, plus Dopamine/Dobutamine (mcg/kg/min) dose x 1, plus Neosynephrine (mcg/kg/min) dose x10, plus Vasopressin (units/kg/hr) [(dose x60)/10,000] = Inotrope Score. Our institution does not include Milrinone in our inotrope score calculation because every patient receives a continuous infusion in the immediate post-operative period. The higher the inotrope score the more cardiac support the patient is requiring or the worse their cardiac function is becoming.|first 48 hours post-op||||Inotrope Score||Inter-Quartile Range|Median
2658788|NCT01595386|Secondary|Changes in Baseline Inflammatory Mediators|Changes in pre-op inflammatory mediators will be assessed at 0, 4, 12, 24 and 48 hours post bypass and used as a secondary outcome.|0, 4,12, 24, and 48 hours post bypass||||pg/mL||Inter-Quartile Range|Median
2658789|NCT01595386|Secondary|Hospital Length of Stay|The average length of hospital stay from the time the subject is admitted to the CICU post-op until they are discharged will be used as a secondary outcome.|Admit to CICU till hospital discharge, approximately 3 weeks||||days||Inter-Quartile Range|Median
2658790|NCT01595386|Secondary|Mean Number of Days Subjects Alive and Ventilator Free|Respiratory variables include such as alive, ventilator free days at 28 days post-op will be used as secondary outcome. The mean number of days subjects were live and ventilator free up to the 28 days after surgery.|up to 28 days post op||||days||Inter-Quartile Range|Median
2658791|NCT01595386|Primary|Incidence of Low Cardiac Output Syndrome (LCOS)|Low Cardiac Output Syndrome (LCOS) within the first 48 hours after post-operative admission to the Pediatric Cardiac Intensive Care Unit was used as the primary outcome. This was defined as a double in inotropic support from post-operative admit, requiring Extracorporeal Membrane Oxygenation (ECMO) support, receiving Cardiopulmonary Resuscitation, or death.|first 48 hours after cardiac intensive care unit (CICU) admission post-op||||percentage of patients|||Number
2658792|NCT01595282|Secondary|Pain Scores 15 Minutes Post-procedure|21-point 0 to 100 scale, where 0 = no pain and 100 = worst possible pain (in increments of five)|Fifteen minutes after the procedure||||units on a scale||Standard Deviation|Mean
2658793|NCT01595282|Secondary|Pain Scores Immediately After Cervical Dilation|21-point 0 to 100 scale where 0 = no pain and 100 = worst possible pain (in increments of five)|Immediately (within 1 minute) after cervical dilation prior to the introduction of the suction cannula||||units on a scale||Standard Deviation|Mean
2659093|NCT01591681|Secondary|Percent of Mornings With Glucose >250 mg/dL|Measured with a study home blood glucose meter.|42 mornings following night of system use||||percentage of mornings|Participants||Number
2658794|NCT01595282|Primary|Immediate Post-procedure Pain Score|The primary endpoint is subjects' immediate post-procedure pain score on a 21-point 0 to 100 scale, 0 = no pain and 100 = worst possible pain (in increments of five). This scale has been previously validated and used for research purposes, including for pain research evaluating suction curettage elsewhere and at our institution (Jensen 1986, Williamson 2004, Allen 2009).|Immediately (within 1 minute) after suction and speculum removal||||units on a scale||Standard Deviation|Mean
2658795|NCT01595009|Secondary|Investigator-assessed Best Overall Response During the Extension Phase (E1)|Best overall response was determined from the sequence of investigator overall lesions responses according to Response Evaluation Criteria in Solid Tumors (RECIST). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progression, a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|from the start of treatment, every 12 weeks for the first year and then every 6 months up to 4 years|The full analysis set, which consisted of all participants who received at least one dose of everolimus during the extension, was analyzed|||Participants|||Count of Participants
2658796|NCT01595009|Secondary|Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1)|The EQ-5D contains 2 sections:1st section has 1 item addressing each of 5 dimensions (mobility, self-care, usual activity, pain/discomfort, anxiety/depression). Each dimension has 3 levels: no problems, some problems, extreme problems, 1-3, respectively. A health state is defined by combining 1 level from each dimension. 243 health states are possible. Each state is referred to in a 5 digit code. E.g., state 11111 indicates no problems on any dimension, while state 11223 indicates no problems with mobility and self-care, some problems with performing usual activities, moderate pain or discomfort and extreme anxiety or depression. The 2nd section measures self-rated health status using a visual analogue scale (VAS) where 100 represents best possible health and 0 represents worst possible health. Patients are asked to rate their current health by placing a mark on the VAS. Scores from each section are then transformed into an overall score of 0 or 1, with 0= higher level of dysfunction.|baseline, every 12 weeks and up to 4 years|Only participants from the full analysis set, who had both baseline and end of treatment measurements, were included in the analysis. The full analysis set, which consisted of all participants who received at least one dose of everolimus during the extension, was analyzed.|||units on a scale||Standard Deviation|Mean
2658797|NCT01595009|Secondary|Change in EORTC QLQ-G.I. NET21 Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1)|The EORTC QLQ-G.I. NET21 contains 21 questions and has three defined multi-item symptom scales (endocrine - 3 questions, gastrointestinal - 5 questions, and treatment related side effects - 3 questions), two single item symptoms (bone/muscle pain and concern about weight loss), two psychosocial scales (social function - 3 questions, disease-related worries - 3 questions) and two other single items (sexuality and communication). For each of the 9 domains, final scores are transformed such that they range from 0-100, where higher scores indicate worsening outcomes. A positive change from baseline indicates worsening.|baseline, every 12 weeks and up to 4 years|Only participants from the full analysis set, who had both baseline and end of treatment measurements, were included in the analysis. The full analysis set, which consisted of all participants who received at least one dose of everolimus during the extension, was analyzed.|||units on a scale||Standard Deviation|Mean
2658798|NCT01595009|Secondary|Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score at the End of Treatment From Baseline (Baseline = First Day of Treatment in the Extension) (E1)|"The EORTC QLQ-C30 contains 30 questions assessed by the participant. There are 9 multiple-item scales: 5 scales that assess aspects of functioning (physical, role, cognitive, emotional, and social); 3 symptom scales (Fatigue, Pain, and Nausea and Vomiting); and a global health status and QOL scale. There are 5 single-item measures assessing additional symptoms (i.e., dyspnea, loss of appetite, insomnia, constipation, and diarrhea) and a single item concerning perceived financial impact of the disease. All but two questions have 4-point scales ranging from Not at all to Very much. The two questions concerning global health status and QOL have 7 point scales with ratings ranging from Very poor to Excellent. For each of the 14 domains, changes are calculated as value at later time point minus value at baseline, and final scores are transformed such that they range from 0-100, where higher scores indicate better outcomes. A positive change from baseline indicates improvement."|baseline, every 12 weeks and up to 4 years|Only participants from the full analysis set, who had both baseline and end of treatment measurements, were included in the analysis. The full analysis set, which consisted of all participants who received at least one dose of everolimus during the extension, was analyzed.|||score on a scale||Standard Deviation|Mean
2658799|NCT01595009|Secondary|Investigator-assessed Progression Free Survival (PFS) (E1)|PFS was defined as the time from the date of the start of therapy in the extension study to the date of the first radiologically documented disease progression or death due to any cause. If a participant had not progressed or died at the analysis cut-off date or when he/she received any further anti-neoplastic therapy, PFS was censored at the time of the last adequate tumor evaluation before the cut-off date or the anti-neoplastic therapy start date.|from first date of treatment in the extension up to 4 years|The full analysis set, which consisted of all participants who received at least one dose of everolimus during the extension, was analyzed|||Days||95% Confidence Interval|Median
2658800|NCT01595009|Secondary|Investigator-assessed Best Overall Response (Core)|Best overall response was determined from the sequence of investigator overall lesions responses according to Response Evaluation Criteria in Solid Tumors (RECIST). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progression, a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|from the start of treatment, every 12 weeks for the first year and then every 6 months up to 19 months|The full analysis set, which consisted of all participants who received at least one dose, was analyzed.|||Participants|||Count of Participants
2659094|NCT01591681|Secondary|Median Morning Blood Glucose|Measured with a study home blood glucose meter.|42 mornings following night of system use||||mg/dl|Participants|Inter-Quartile Range|Median
2658801|NCT01595009|Secondary|Mean EQ-5D Visual Analogue Scale (VAS) Score (Core)|"The EQ-5D is divided into two distinct sections. The first section includes one item addressing each of five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). Patients rate each of these items from no problem, some problem, or extreme problem. A composite health index is then defined by combining the levels for each dimension. The second section of the questionnaire measures self-rated (global) health status utilizing a vertically oriented visual analogue scale where 100 represents the best possible health state and 0 represents the worst possible health state. Respondents are asked to rate their current health by placing a mark along this continuum. The scores from each section are then transformed into a single health utility score. Overall scores range from 0 to 1 with lower scores representing a higher level of dysfunction."|Baseline, weeks 4, 8, 20, 32, 44, and end of treatment (EOT) up to week 82|The full analysis set, which consisted of all participants who received at least one dose of everolimus, was considered for the analysis. Only participants with measurement at each given time point were analyzed for that time point.|||units on a scale||Standard Deviation|Mean
2658802|NCT01595009|Secondary|Number and Percentage of Participants With Ratings of 'no Problem, 'Some Problem' and 'Extreme Problem' in the EuroQol Five Dimensions Questionnaire (EQ-5D) (Core)|"The EQ-5D is divided into two distinct sections. The first section includes one item addressing each of five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). Patients rate each of these items from no problem, some problem, or extreme problem. A composite health index is then defined by combining the levels for each dimension. The second section of the questionnaire measures self-rated (global) health status utilizing a vertically oriented visual analogue scale where 100 represents the best possible health state and 0 represents the worst possible health state. Respondents are asked to rate their current health by placing a mark along this continuum. The scores from each section are then transformed into a single health utility score. Overall scores range from 0 to 1 with lower scores representing a higher level of dysfunction."|Baseline, weeks 4, 8, 20, 32, 44, and end of treatment (EOT) up to week 82|The full analysis set, which consisted of all participants who received at least one dose of everolimus, was analyzed.|||Participants|||Count of Participants
2658803|NCT01595009|Secondary|Mean EORTC QLQ-G.I. NET21 Score (Core)|The EORTC QLQ-G.I. NET21 contains 21 questions and has three defined multi-item symptom scales (endocrine - 3 questions, gastrointestinal - 5 questions, and treatment related side effects - 3 questions), two single item symptoms (bone/muscle pain and concern about weight loss), two psychosocial scales (social function - 3 questions and disease-related worries - 3 questions) and two other single items (sexuality and communication). For each of the 9 domains, final scores are transformed such that they range from 0-100, where higher scores indicate worsening.|Baseline, weeks 4, 8, 20, 32, 44, and end of treatment (EOT) up to week 82|The full analysis set, which consisted of all participants who received at least one dose of everolimus, was considered for the analysis. Only participants with measurement at each given time point were analyzed for that time point.|||units on a scale||Standard Deviation|Mean
2658804|NCT01595009|Secondary|Mean European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Score (Core)|"The EORTC QLQ-C30 contains 30 questions assessed by the participant. There are 9 multiple-item scales: 5 scales that assess aspects of functioning (physical, role functioning, cognitive, emotional, and social); 3 symptom scales (Fatigue, Pain, and Nausea and Vomiting); and a global health status/Quality of Life (QOL) scale. There are 5 single-item measures assessing additional symptoms (i.e., dyspnea, loss of appetite, insomnia, constipation, and diarrhea) and a single item concerning perceived financial impact of the disease. All but two questions have 4-point scales ranging from Not at all to Very much. The two questions concerning global health status/ QOL have 7 point scales with ratings ranging from Very poor to Excellent. For each of the 14 domains, final scores are transformed such that they range from 0-100, where higher scores indicate improvement."|Baseline, weeks 4, 8, 20, 32, 44, and end of treatment (EOT) up to week 82|The full analysis set, which consisted of all participants who received at least one dose of everolimus, was considered for the analysis. Only participants with measurement at each given time point were analyzed for that time point.|||units on a scale||Standard Deviation|Mean
2658805|NCT01595009|Secondary|Investigator-assessed Progression Free Survival (PFS) (Core)|PFS was defined as the time from the date of the first dose to the date of the first radiologically documented disease progression or death due to any cause. If a participant had not progressed or died at the study end date or when he/she received any further anti-neoplastic therapy, PFS was censored at the time of the last tumor assessment before the end of study date. Progression was defined,using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|from the day of first treatment up to 19 months|The full analysis set, which consisted of all participants who received at least one dose, was analyzed.|||Months||95% Confidence Interval|Median
2658806|NCT01595009|Primary|Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths During the Extension Phase (E1)|The number of participants with AEs, SAEs and deaths were assessed.|from the first day of treatment in the extension up to 4 years|The safety set, which consisted of all participants who received at least one dose of everolimus during the extension and had at least one post-baseline safety assessment during the extension, was analyzed.|||Participants|||Count of Participants
2658807|NCT01595009|Primary|Number and Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths (Core)|The number of participants with AEs, SAEs and deaths were assessed.|from the day of first treatment up to 19 months|The safety population, which consisted of all patients who received at least one dose of everolimus and had at least one post-baseline safety assessment, was analyzed.|||Participants|||Count of Participants
2658825|NCT01594749|Secondary|Percentage of Participants With No Vomiting From 0 to 120 Hours After Initiation of MEC|No Vomiting was defined as no emetic (vomiting) episodes, including no vomiting and no retching or dry heaves (attempts to vomit that are not productive of stomach contents), regardless of use of rescue medication.|0 to 120 hours after initiation of MEC|The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.|||Percentage of participants|||Number
2658808|NCT01594970|Other Pre-specified|Change From Baseline in Hyperemia Severity in the Study Eye|Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia was graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). 'Lower' categories refer to grades 0, 0.5 and 1, and 'higher' categories refer to grades 2 and 3. Change in hyperemia severity was classified as improved, no change or worsened based on the change in the hyperemia grading category from higher to lower, no change in category or lower to higher, respectively. The numbers of participants in each category are presented.|Baseline, Week 12|Intent to Treat: all treated subjects with data at this time point|||Participants|||Number
2658809|NCT01594970|Secondary|Overall Percent Change From Baseline in IOP|IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement).|Baseline, Week 6, Week 12|Intent to Treat: all treated subjects with data at this time point|||Percent Change||Standard Deviation|Mean
2658810|NCT01594970|Secondary|Change From Baseline in Intraocular Pressure (IOP)|IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).|Baseline, Week 6, Week 12|Intent to Treat: all treated subjects|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2658811|NCT01594970|Primary|Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale|Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of participants in each severity grade are presented.|Week 12|Intent to Treat: all treated subjects with data at this time point|||Participants|||Number
2658812|NCT01594853|Primary|Change in Maximal Voluntary Contraction of the Hip Flexors From Baseline to End of Training and to Post-training|Here, we will assess whether the degree of a person's white matter integrity (i.e. for tracts of interest as measured from MRI) predicts their ability to benefit from exercise. Our prediction is that those individuals with preserved white matter integrity will show the greatest improvement in hip flexor strength.|Participants are assessed at baseline (visit 1, enrollment), end of training (visit 2, week 12) and post-training (visit 3, week 18).|For the follow up visit, there are fewer participants in the analysis because 5 female carriers and 1 control were unable to return for the third follow up visit due to burden to travel costs.|||kg||Standard Deviation|Mean
2658813|NCT01594827|Secondary|Time to First Anti-MRSA Antibiotics (After Treatment Period)|Time between completion of Study Drug and need for anti-MRSA antibiotics to control or treat symptoms|Completion of Study Drug to Day 118||||days||Standard Deviation|Mean
2658814|NCT01594827|Secondary|Development of Antibiotic Resistance|Number of patients with newly developed MRSA resistance to vancomycin, TMP/SMX, doxycycline, or rifampin.|Day 58 (Visit 5)|No resistance to doxycycline or TMP/SMX. All developed resistance was to rifampin.|||Participants|||Count of Participants
2658815|NCT01594827|Secondary|Change in Patient Reported Quality of Life (CFQ-R)(Respiratory)|Change in Patient Reported Quality of Life (CFQ-R)(respiratory) from baseline to Days 29 and 58. CFQ-R stands for Cystic Fibrosis Quality of Life Measure, Respiratory Domain. Overall range of absolute score 0 to +80. Higher score means better quality of life. Positive change in score means improvement in quality of life. Minimally clinically significant difference: +/- 4.0 units.|Days 29 and 58||||units on a scale||Standard Error|Mean
2658816|NCT01594827|Secondary|Change if FEV1% Predicted From Screening|Change in FEV1% predicted from Screening at Days 29, 58, and 118 in treatment vs. standard care group|Days 29, 58, and 118||||FEV1% predicted||Standard Error|Mean
2658817|NCT01594827|Secondary|Total Number of Pulmonary Exacerbations|Total Number of Pulmonary Exacerbations using a standardized exacerbation definition at Days 58 and Days 118 in treatment vs. standard care group|Days 58 and 118||||Exacerbations|||Number
2658818|NCT01594827|Secondary|Time to First CF Exacerbation|Time to First CF Exacerbation using a standardized exacerbation definition from Day 1 to Day 118|Day 1 to Day 118||||Days||Standard Deviation|Mean
2658819|NCT01594827|Secondary|Change in Forced Expiratory Volume (FEV1)% Predicted From Baseline to Day 58|Change in Forced Expiratory Volume (FEV1)% predicted from baseline to day number 58|Baseline, Day 58||||% predicted FEV1||Inter-Quartile Range|Median
2658820|NCT01594827|Secondary|Percentage of Patients MRSA Free by Induced Sputum Respiratory Tract Culture|Percentage of patients MRSA free by induced sputum respiratory tract culture one day after completion of four-week eradication protocol (Day 29) in intervention arm vs standard treatment arm|Day 29||||Participants|||Count of Participants
2658821|NCT01594827|Primary|Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture|The hypothesis for our primary outcome is that the aggressive treatment arm will result in significantly greater eradication of persistent MRSA from the respiratory tract of CF adolescents and adults on day 58 (1 month after completion of therapy) compared to the placebo/standard treatment arm. Our primary outcome will be comparing the proportion of CF patients in the treatment arm who have a negative induced sputum MRSA culture at Day 58 to the proportion of patients in the placebo arm who have a negative induced sputum MRSA culture at Day 58.|Day 58 (Visit 5), approximately 1 month after completion of the MRSA treatment protocol||||Participants|||Count of Participants
2658822|NCT01594762|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAE)|The number of participants with TEAEs, including Serious TEAEs, are reported|28 days|Safety|||Participants|||Count of Participants
2658823|NCT01594762|Secondary|Number of Participants With Microbiological Response|The numbers of participants with Microbiological Response, defined are eradication of all baseline pathogens, are reported.|28 days|Intent-To-Treat Microbiological (positive for baseline pathogens)|||Participants|||Count of Participants
2658824|NCT01594762|Primary|Number of Participants With Clinical Response|The numbers of participants with Clinical Response, defined as resolution of infection, are reported.|28 days|Intent-To-Treat|||Participants|||Count of Participants
2658854|NCT01594385|Other Pre-specified|Patient Mortality|Assessment of patient mortality at 28 days, with subsequent determination of survival (i.e., patient status at last known follow-up)|28 days & end of follow-up|Note: Both mortalities in the Seprafilm group involved withdrawal of care as per previously stated patient wishes.|||Mortalities|||Number
2658826|NCT01594749|Secondary|Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC|A Complete Response was defined as no vomiting and no use of rescue medication.|0 to 24 hours after initiation of MEC|The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.|||Percentage of Participants|||Number
2658827|NCT01594749|Secondary|Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC|A Complete Response was defined as no vomiting and no use of rescue medication.|0 to 120 hours after initiation of MEC|The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.|||Percentage of Participants|||Number
2658828|NCT01594749|Primary|Percentage of Participants With Severe Infusion-site Reactions|The percentages of participants with severe infusion-site reactions, including severe site pain, or severe site redness (erythema) or severe site hardness (induration) are presented.|Day 1 through Day 17, inclusive|The Safety population consisted of all randomized participants who received study drug as treated.|||Percentage of Participants|||Number
2658829|NCT01594749|Primary|Percentage of Participants With Infusion-site Thrombophlebitis|The percentages of participants with infusion-site thrombophlebitis are presented. Thrombophlebitis was defined as a condition affecting a superficial vein used for an IV infusion, associated with red color, hardness upon palpation, and the presence of a tender cord and possible fever.|Day 1 through Day 17, inclusive|The Safety population consisted of all randomized participants who received study drug as treated.|||Percentage of Participants|||Number
2658830|NCT01594749|Primary|Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC)|A Complete Response was defined as no vomiting and no use of rescue medication.|25 to 120 hours after initiation of MEC|The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.|||Percentage of Participants|||Number
2658831|NCT01594528|Primary|Indicators / Minute|number of corporal mobility, facial expression and sound indicators|during pain tests (average 1 hour)||||indicators/minute||95% Confidence Interval|Median
2658832|NCT01594515|Secondary|AUC0-infinity of BI 1015550|Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity|−0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing|The pharmacokinetic analysis set (PKS) included all subjects in the TS who provided at least 1 evaluable observation for a PK endpoint. A subject was considered to be evaluable if he provided sufficient data, did not vomit at or before 2x median tmax and completed the trial without any iPV relevant to the PK evaluation.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2658833|NCT01594515|Secondary|Cmax of BI 1015550|Maximum measured concentration of the analyte in plasma.|−0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing|The pharmacokinetic analysis set (PKS) included all subjects in the TS who provided at least 1 evaluable observation for a PK endpoint. A subject was considered to be evaluable if he provided sufficient data, did not vomit at or before 2x median tmax and completed the trial without any iPV relevant to the PK evaluation.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2658834|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in Physical Examinations|Percentage of subjects with clinically relevant abnormalities in physical examinations.|From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.|||Percentage of Participants|||Number
2658835|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability|Percentage of subjects with clinically relevant abnormalities in tolerability assessed by the investigator.|From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.|||Percentage of Participants|||Number
2658836|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs|Percentage of subjects with clinically relevant abnormalities in 12-lead ECGs.|Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.|||Percentage of Participants|||Number
2658837|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs|Percentage of subjects with clinically relevant abnormalities in vital signs (blood pressure, pulse rate, respiratory rate, oral body temperature, orthostasis test).|Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.|||Percentage of Participants|||Number
2658838|NCT01594515|Primary|Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests|Percentage of subjects with clinically relevant abnormalities in clinical laboratory tests (haematology, clinical chemistry, haemoccult® test, and urinalysis).|Day -21 to -2, upto -72 hours, 4h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).|The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment.|||Percentage of Participants|||Number
2658908|NCT01593592|Secondary|The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements.|Severe adverse effects to the used medications and dietary supplements, these may expose the participants to major morbidity and may change the outcomes in them.|8 weeks||||participants|||Number
2658840|NCT01594476|Secondary|Pain With IUD Placement|"Subjects were asked to record their current pain immediate at the time of the IUD placement on a 100 millimeter (mm) visual analog scale (VAS). A VAS is a 100 mm horizontal line with anchors stating no pain and worst pain in my life. The VAS score is calculated by measuring the distance in millimeters between the left end of the scale and the intersection of a vertical mark placed by the subject. Maximum score is 100 (range 0-100). Higher scores indicate higher pain. The distance from the left side of the 10 cm line to the mark will be measured in millimeters and compared between randomization groups if they received an IUD at the allocated timing of 18-24 or 39-45 days."|At the time of IUD placement.|Subjects analyzed by actual timing of IUD insertion|||mm||Standard Deviation|Mean
2658841|NCT01594476|Secondary|Number of Subjects With Adverse Events|Subjects will be followed for 6 months each. Over the 6 month study period, the number and proportion of subjects who experience adverse events including treatment for infection, IUD expulsion or IUD perforation will be assessed.|Six months after delivery|All subjects analyzed. This includes all subjects enrolled on protocol and allocated. There were no adverse events in the subjects excluded after allocation.|||Participants|||Count of Participants
2658842|NCT01594476|Secondary|Subjects With an IUD at 6 Months Postpartum|Subjects will return to clinic for an ultrasound and exam at six months after delivery. We will compare the proportion of subjects with an IUD at this time of those randomized to each placement timing.|Six months after delivery|Population is subject randomization groups.|||Participants|||Count of Participants
2658843|NCT01594476|Secondary|Uterine Thickness at the Fundus|Transvaginal ultrasound will be performed immediately following IUD placement. The thickness of the uterine myometrium at the fundus from the endometrium to the outer edge of the serosa will be measured in centimeters using an ultrasound caliper in the sagittal view.|At IUD placement|Subjects who had their IUD placed at the allocated timing of 18-24 days versus 39-45 days|||cm||Standard Deviation|Mean
2658844|NCT01594476|Secondary|Satisfaction With the Timing of IUD Placement.|"Subjects were asked to record their overall satisfaction with the timing of the IUD placement on a 100 millimeter (mm) visual analog scale (VAS). A VAS is a 100 mm horizontal line with anchors stating very dissatisfied and very satisfied. The VAS score is calculated by measuring the distance in millimeters between the left end of the scale and the intersection of a vertical mark placed by the subject. Maximum score is 100 (range 0-100). Higher scores indicate higher satisfaction."|Immediately following IUD placement.|Includes all subjects enrolled on protocol who underwent IUD placement at a study visit at any timing prior to 3 months postpartum. Comparison is based on randomization timing but actual timing of placement may have differed. Numbers differ from primary outcome due to removals and expulsion prior to 3 months, and placement outside study visits.|||mm on VAS||Standard Deviation|Mean
2658845|NCT01594476|Primary|Subjects With an IUD at 3 Months Postpartum|Subjects will be contacted by phone or email at 3 months after delivery. We will compare the proportion of subjects who report having an IUD in place at 3 months after delivery of those who are randomized to each group (placement at either 3 weeks or 6 weeks) .|Three months after delivery|Data analyzed as intent to treat regardless of when they had their IUD placed. This is IUD placed by 3 months in each group.|||Participants|||Count of Participants
2658846|NCT01594424|Primary|Number of Participants With Serious Infectious Complications Following Transplantation|patients will be in the study for up to 2 years|24 months||||participants|||Number
2658847|NCT01594411|Primary|Change in Clinicians' Treatment Decision After Age/Sex/Gene Expression Score|The primary objective was to assess whether the Age/Sex/Gene Expression Score (ASGES) altered clinicians' evaluations, defined by a change in patient management from preliminary to final decision. The change was prospectively defined as a downgrade or upgrade in intensity of the diagnostic plan based on the following hierarchical categories:(1) no further cardiac testing or treatment, (2) lifestyle changes or medical therapy, (3) stress testing (with or without imaging) or computed tomography/coronary angiography, or (4) invasive coronary angiography. The ASGES algorithm comprises expression values for 23 genes from peripheral blood cells in 6 terms, patient age, and sex. The changes in gene expression are quantified using an algorithm that generates a ASGES ranging from 1 to 40. A score <=15 indicates a low risk of underlying obstructive coronary disease. The ASGES has a negative predictive value of 96% for ASGES <=15 in a population referred to myocardial perfusion imaging.|pre- and post- gene expression testing results (on average 2-3 days to receive ASGES)|The study sites included 9 clinicians at 4 community-based primary care practices who assessed all participants with a valid ASGES.|||number of subjects|||Number
2658848|NCT01594385|Other Pre-specified|Would Complication|Tracking of wound infection, dehiscence, hernia, or any other would-related complication of complaint|Up to 1 year follow-up period||||Wound complication|||Number
2658849|NCT01594385|Other Pre-specified|Patient Functional Outcomes|"Assessment of Glasgow Outcome Scale (GOS) and the Functional Outcome Measures (FOM) during the available follow-up period.~FOM Source: [1] Ohio Dept of Public Safety. Ohio Trauma Registry Data Dictionary. Columbus: 2004.~FOM Scale range: 1 (worst) to 4 (best); GOS Scale: 1 (worst) to 5 (best)~FOM Feeding Subscale~Fully dependent~Partially dependent~Independent w/device~Fully independent~FOM Locomotion Subscale~Fully dependent~Partially dependent~Independent w/device~Fully independent~FOM Expression/Communication Subscale~Fully dependent~Partially dependent~Independent w/device~Fully independent~Glasgow Outcome Scale:~Death~Persistent vegetative state: Minimal responsiveness~Severe disability: Conscious but disabled; dependent on others for daily support~Moderate disability: Disabled but independent; can work in sheltered setting~Good recovery: Resumption of normal life despite minor deficits"|Up to 1 year follow-up|Please see Outcome Measure Description [above] for exact measure(s) utilized, including measurement scale(s).|||units on a scale||Standard Deviation|Mean
2658850|NCT01594385|Other Pre-specified|Bowel Obstruction|Determination of bowel obstruction during the entire available study follow-up period|Up to 1 year follow-up||||Bowel obstruction|||Number
2658851|NCT01594385|Other Pre-specified|Infection / Abscess / Sepsis|Assessment of any infection, abscess, or sepsis during the initial and the follow-up periods|Up to 1 year||||Total events|||Number
2658852|NCT01594385|Other Pre-specified|Ventral Hernia|Determination of ventral hernia presence during follow-up visits|Up to 1 year follow-up||||Hernia|||Number
2658853|NCT01594385|Other Pre-specified|Enterocutaneous and Other Fistula|Determination of enterocutaneous/other fistula among study patients during the hospitalization and the follow-up interval|Up to 1 year post-injury||||Total events|||Number
2658855|NCT01594385|Secondary|Wound Healing Characteristics|There will not be a fixed duration of outpatient follow-up (fixed follow-up in trauma patients is not practical due to the unpredictable nature of trauma population), an average (mean) follow-up will be determined for the entire cohort of patients for the purposes of the study, up to a maximum of 1 year (if available) following hospital discharge.|Participants will be followed until their open abdomen is closed. Depending on the nature and severity of the wound, this period may last as long as 1 year after the patient has been discharged.|"Wound areas for Seprafilm and No Seprafilm groups were obtained serially, by measuring each wound horizontally and vertically and multiplying measurements (in centimeters) to determine the estimated area in cm squared."|||Square Centimeters (cm2)||Standard Deviation|Mean
2658856|NCT01594385|Primary|Adhesion Characteristics|"Zuhlke adhesion score (1 - minimum to 4 - maximum)~= filmy adhesions, easy to separate by blunt dissection~= stronger adhesions; blunt dissection possible, partly sharp dissection necessary; beginning of vascularization~= strong adhesions; lysis possible by sharp dissection only; clear vascularization~= very strong adhesions; lysis possible by sharp dissection only; organs strongly attached with severe adhesions; damage to organs hardly preventable"|Up to 1 year||||Scores on a scale|Zuhlke Adhesion Score|Standard Error|Mean
2658857|NCT01594294|Secondary|Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis. Contact lenses were on-eye for this assessment.|Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.|||seconds|Participants|Standard Deviation|Mean
2658858|NCT01594294|Primary|Mean Upper Eyelid Margin Staining|The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.|Baseline (Day 0), Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.|||square millimeters|Participants|Standard Deviation|Mean
2658859|NCT01594294|Primary|Mean Upper Eyelid Redness|The contact lenses were removed and upper eyelid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.|Baseline (Day 0), Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.|||percentage of total surface measured|Participants|Standard Deviation|Mean
2658860|NCT01594294|Primary|Maximum Eyelid Hyperaemia|Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale: 0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.|Baseline (Day 0), Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.|||units on a scale|Participants|Full Range|Median
2658861|NCT01594294|Primary|Maximum Papillae|Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale: 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis. Contact lenses were not worn for this assessment.|Baseline (Day 0), Month 3|This analysis population includes all participants who completed the study as per the protocol, minus missing responses.|||Units on a scale|Participants|Full Range|Median
2658862|NCT01594281|Secondary|Number of PRP Laser Spots Until EOCS|The total number of PRP laser spots from baseline until EOCS was calculated. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.|Baseline to EOCS|Safety Set. Only patients with at least 1 laser therapy until EOCS are included in the analysis. This outcome measure was pre-specified for the PRP and the ranibizumab+PRP arms only.|||PRP laser spots||Standard Deviation|Mean
2658863|NCT01594281|Secondary|Number of Ranibizumab Injections Until EOCS|The total number of ranibizumab injections until EOCS was calculated. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.|Baseline to EOCS|Safety Set. This outcome measure was pre-specified for the ranibizumab mono and ranibizumab+PRP arms only.|||injections||Standard Deviation|Mean
2658864|NCT01594281|Secondary|Change From Baseline in Foveal Center Point Retinal Thickness at EOCS|Foveal center point retinal thickness was assessed by a central reading center using Optical Coherence Tomography images. A positive change value may indicate disease progression. One eye (study eye) contributed to the analysis.|Baseline, EOCS|FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included.|||micrometer||Standard Deviation|Mean
2658865|NCT01594281|Secondary|Change From Baseline in Central Subfield Thickness at EOCS|Central subfield retinal thickness was assessed by a central reading center using Optical Coherence Tomography images. A positive change value may indicate disease progression. One eye (study eye) contributed to the analysis.|Baseline, EOCS|FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included.|||micrometer||Standard Deviation|Mean
2658879|NCT01593852|Secondary|Physician Professional Judgment on Adequacy of Images for Performing the EP Procedure|If fluoroscopy time (see results in other secondary outcomes), number of exposure frames (see below) and procedure duration (see results in other secondary outcomes) are equivalent between the two groups, this will indicate that image quality (IQ) is equally adequate in both groups.|Day 0||||Number of exposure frames||Standard Deviation|Mean
2658880|NCT01593852|Secondary|Fluoroscopy Time||Day 0||||minutes||Standard Deviation|Mean
2658881|NCT01593852|Secondary|Procedure Duration||Day 0||||minutes||Standard Deviation|Mean
2658909|NCT01593592|Secondary|Severe Adverse Effects to the Used Medications and Dietary Supplements.||4 weeks||||percentage of participants|||Number
2658866|NCT01594281|Secondary|Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS|"The severity level of diabetic retinopathy was determined using the ETDRS severity scale. However, in contrast to the original ETDRS severity scale, wide field fluorescein angiography images were used in addition to color fundus photography for identification of NVs and prior PRP treatment was not considered for determining the severity level. Eyes could be graded in the following classes: DR absent (10), questionable DR (14,15), NPDR (20-53), mild PDR (60-61), moderate PDR (65), high risk PDR (71-75), advanced PDR (81-85) and cannot grade (90). One eye (study eye) contributed to the analysis. No statistical analysis was conducted for ≥ 1 class deterioration or ≥ 2 class deterioration from Baseline at EOCS because ratios could not be calculated in case of zero frequencies in at least one of the three treatment groups."|Baseline, EOCS|FAS. Only patients with both values at baseline and any post-baseline value were included.|||participants|||Number
2658867|NCT01594281|Secondary|Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS|BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at a testing distance of 4 meters. No clinically relevant change was defined as <5 letters gain or loss. A higher positive change value may indicate a greater improvement in visual acuity. One eye (study eye) contributed to the analysis.|Baseline, EOCS|FAS; LOCF|||percentage of participants|||Number
2658868|NCT01594281|Secondary|Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at EOCS|BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at a testing distance of 4 meters. A higher number of ETDRS letters may indicate better visual acuity. One eye (study eye) contributed to the analysis.|EOCS|FAS; LOCF|||letters||Standard Deviation|Mean
2658869|NCT01594281|Secondary|Change From Baseline in Area of Neovascularizations (NVs) at Month 3|The area of neovascularizations (NV) was assessed by a central reading center via fluorescein angiography (FA) images. The area of NV was calculated as the sum of area of neovascularization of the disc (NVD) and neovascularization elsewhere (NVE) and was recorded in square millimeters. A higher positive change value may indicate a greater formation of new, abnormal blood vessels and thus disease progression. One eye (study eye) contributed to the analysis.|Baseline, Month 3|FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included.|||square millimeters||Standard Deviation|Mean
2658870|NCT01594281|Primary|Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS)|The area of neovascularizations (NV) was assessed by a central reading center via fluorescein angiography (FA) images. The area of NV was calculated as the sum of area of neovascularization of the disc (NVD) and neovascularization elsewhere (NVE) and was recorded in square millimeters. A higher positive change value may indicate a greater formation of new, abnormal blood vessels and thus disease progression. One eye (study eye) contributed to the analysis.|Baseline, EOCS|FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included.|||square millimeters||Standard Deviation|Mean
2658871|NCT01594125|Secondary|Number of Participants With Response by Alpha Fetoprotein (AFP)|Response by AFP is defined as 20% or more decline in AFP between the baseline value and the AFP value after three courses (12 weeks) of therapy. If patients only receive two courses of therapy the AFP value after two courses (8 weeks) will be used for the analysis.|up to 28 months|Patients from TS and AFP evaluation (>20μg/L) at baseline and post-baseline AFP assessment after two or three courses.|||participants|||Number
2658872|NCT01594125|Secondary|Time to Progression (TTP)|TTP is defined as the duration from the start date of the study treatment to PD according to RECIST 1.0.|up to 28 months|Patients from TS|||months||Inter-Quartile Range|Median
2658873|NCT01594125|Secondary|Progression Free Survival (PFS)|PFS is defined as the duration from start date of the study treatment to PD according to RECIST 1.0, or any death whichever occurs earlier.|up to 28 months|Patients from TS|||months||Inter-Quartile Range|Median
2658874|NCT01594125|Secondary|Number of Participants With Objective Tumour Response According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|"Objective response (Complete response (CR) + Partial response (PR), regardless of confirmation) is derived from a patient's best objective response by RECIST. Best objective response is calculated based on the overall visit response from each assessment. Best objective response represents the best response a patient has had during their time in the study up until progression, last evaluable assessment in the absence of progression or the start of subsequent anti-cancer therapy. For patients whose progression event is death, best objective response will be calculated based on data up until the last evaluable RECIST assessment prior to death."|up to 28 months|Treated Set (TS): The treated set includes all patients who were administered at least one dose of any study medication.|||participants|||Number
2658875|NCT01594125|Primary|Number of Participants With Dose Limiting Toxicities to Determine Maximum Tolerated Dose (MTD) of Nintedanib|The MTD is based on the incidence of Dose Limiting Toxicities (DLTs). A drug-related AE was considered as a DLT if one of the following met: CTCAE grade 4 thrombocytopenia of any duration, CTCAE grade 4 neutropenia lasting for ≥8 days, CTCAE grade 4 febrile neutropenia of any duration, CTCAE grade 3 or 4 non-haematologic toxicity (with the following exception: Alopecia, Vomiting, nausea, or diarrhoea with no adequate supportive care, Transient electrolyte abnormality, which resolves spontaneously or can be corrected with appropriate treatment within 3 days, Liver toxicity), Liver enzyme toxicity of AST, ALT, alkaline phosphatase [ALP] elevation >5x ULN, or total bilirubin >3x ULN if baseline liver enzymes are within the normal range, or AST, ALT or ALP > baseline value + 4x ULN if the baseline value is elevated. The MTD was determined to be 200mg bid.|up to 28 days|Patients from the MTD set: The MTD set contains only treated patients from the dose escalation that were not replaced for MTD determination.|||participants|||Number
2658876|NCT01593852|Primary|Cumulative Air Kerma (AK) Value|Percentage reduction of reducted X-ray dose settings (Allura Clarity) vs. regular X-ray dose settings (AlluraXper) in AK.|Day 0||||mGy||Inter-Quartile Range|Median
2658877|NCT01593852|Secondary|Serious Adverse Events||Day 0 if any||||participants|||Number
2658878|NCT01593852|Secondary|Usage of Physician Controlled Dose Settings|In both groups, default fluoroscopy dose settings were 'low', but could be changed by the operator to a medium or high setting for better imaging. The necessity to increase fluoroscopy dose for better imaging to medium or high was registered as a percentage of total number of fluoroscopy frames.|Day 0||||percentage of total # of fluoro frames||Standard Deviation|Mean
2658882|NCT01593852|Secondary|Physician Professional Judgment on Procedural Success|Measurement of professional judgment (yes/no) of the treating physician.|Day 0||||percentage of procedural success|||Number
2658891|NCT01593787|Secondary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8|Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements.|baseline, 8 weeks|Full Analysis Set (FAS): This set included all participants who entered the treatment epoch. Patients who were not qualified to enter the treatment epoch were excluded from the FAS provided those participants did not receive LCZ696.|||mmHg||Standard Deviation|Mean
2658892|NCT01593787|Primary|Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death)|Percentage of patients with total adverse events, serious adverse events and death were reported.|8 weeks|Safety Set: This set included all participants who received at least one dose of LCZ696. AE analysis was determined by actual treatment, i.e. the LCZ696 dose on the day in which the corresponding summary was targeting. Other safety analysis was determined by the maximum treatment.|||Percentage of participants|||Number
2658893|NCT01593748|Secondary|Response Rate|"Response rate is defined as follows:~Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study"|minimum of 18 months||||Participants|||Count of Participants
2658894|NCT01593748|Secondary|Average Score of Quality of Life|"To estimate the quality of life of patient with metastatic an/or locally advanced recurrent STS using the Quality of Life Questionnaire (QLQ-C30). The QLQ-C30 is scored on a scale from 0-100 with 0 indicating never and 100 indicating always in regard the the participants' experience of fatigue, nausea/vomiting, pain, disponae, insomnia, appetite loss, constipation, diarrhea, financial concerns at 4 time points through the study."|Baseline, Cycle 2, Cycle 6 and End of Treatment||||score on a scale||Standard Deviation|Mean
2658895|NCT01593748|Secondary|Hazard Ratio|Hazard ratio is defined as the rate of survival in the experimental group versus the standard of care group. A hazard ratio of greater than one or less than one means that survival was better in one of the groups.|minimum of 18 months||||hazard ratio||95% Confidence Interval|Number
2658896|NCT01593748|Primary|Rate of Participants With Grade 3 or Higher Toxicity|Toxicity is graded according to the CTCAE v 4.|30 days post end of treatment||||Participants|||Count of Participants
2658897|NCT01593748|Primary|Average Number of Months of Progression-free Survival|To estimate the PFS of the combination of G+P or G+T in patients with metastatic and/or locally advanced or recurrent STS. Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.|minimum of 18 months||||months||95% Confidence Interval|Median
2658898|NCT01593722|Other Pre-specified|Treatment Efficacy|Proportion of subjects without signs of infection|6 months|Microfilarial count and symptoms|||participants|||Number
2658899|NCT01593722|Secondary|Proportion of Subjects Who Clear Microfilaremia||14 days||||participants|||Number
2658900|NCT01593722|Secondary|Eosinophil Activation|Levels of surface marker expression on eosinophils|3 days||||% cells expressing CD69||Full Range|Geometric Mean
2658901|NCT01593722|Secondary|The Frequency of Adverse Events|Symptoms, signs and laboratory abnormalities occurring in the 7 days post-treatment|7 days||||events|||Number
2658902|NCT01593722|Primary|The Peak % of Baseline Eosinophil Count Measured During the First 7 Days Post-treatment.||7 days||||percentage of baseline||Full Range|Geometric Mean
2658903|NCT01593670|Secondary|Overall Survival|Patients alive at 1 year.|1 Year||||Participants|||Count of Participants
2658904|NCT01593670|Secondary|Number of Patients Who Had Natural Killer (NK) Cell Expansion|NK cell expansion is defined as the presence of donor NK cells in the recipient at Day 8 post NK cell infusion.|After Cycle 2 (approx. 3 months)||||Participants|||Count of Participants
2658905|NCT01593670|Secondary|Number of Patients Who Became Transfusion Independent||4-6 Months Post Start of Cycle 1|7 of the 9 patients were not evaluable for this outcome measure - 5 went on to stem cell transplant and 2 died before reaching the 4-6 month post start of cycle 1 milestone.This left 2 evaluable patients for the outcome measure, and thus this endpoint is not informative due to lack of evaluable patients.|||Participants|||Count of Participants
2658906|NCT01593670|Secondary|Number of Patients Who Experienced Grade 3 or Higher Non-hematologic Adverse Events|Adverse events (AEs) will be graded using Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Non-hematologic adverse events are defined as untoward medical occurrences associated with the use of a study drug whether or not considered study drug related, excluding those events involving white blood cells, neutrophils, red blood cells or platelets. In general, grade 3 AEs are defined as 1) being severe or medically significant but,not immediately life-threatening; 2) requiring hospitalization or prolongation of hospitalization; 3) disabling; or 4) limiting self care activities. Grade 4 AEs are defined as 1) having life-threatening consequences; or 2) requiring urgent intervention. Grade 5 AEs are defined as causing death related to an adverse event.|Day 1 through Month 3||||Participants|||Count of Participants
2658907|NCT01593670|Primary|The Number of Patients Who Achieved a Clinical Response|Clinical response includes: Complete Response (less than 5% myeloblasts present in the bone marrow and in the peripheral blood a hemoglobin of at least 11g/dl, platelets of at least 100 X 10E9/L, neutrophils of at least 1.0 X 10E9/L, and blasts 0%); Partial Response (all Complete Response criteria if previously abnormal except bone marrow myeloblasts are decreased by more than 50% over pre-treatment, but still greater than 5%); and hematologic improvement (a hemoglobin increase of greater than 1.5g/dl or decreased red blood cell transfusions by at least 4 per 8 week period, a platelet increase of more than 30 X 10E9/L for patients with a baseline of more than 20 X 10E9/L or an increase by 100% for those with a baseline of less than 20 X 10E9/L, and a neutrophil increase of at least 100% and an absolute increase of greater than 0.5 X 10E9/L.|After 2 Courses of Treatment (Approx. 3 months)||||Participants|||Count of Participants
2659095|NCT01591681|Secondary|Proportion of Nights With a Sensor Glucose Value </= 50 mg/dL||Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use||||percentage of nights|Participants||Number
2658910|NCT01593592|Primary|Eradication of H Pylori Infection 4 Weeks After Completion of Therapy|H. pylori eradication is defined in this study as concomitant negativity to all previously positive tests (H. pylori antigen in stool; histopathological confirmation of H. pylori bacilli; and rapid urease test.) 4 weeks after the end of therapy.|4 weeks therapy|It is assessment of all the 70 participants about H pylori eradication status|||participants|||Number
2658911|NCT01593254|Secondary|Overall Survival (OS)|OS is how long patients are likely to remain alive. It is the time from randomization date to death date.|Up to 10 years||2023-02-28|02/2023||||
2658912|NCT01593254|Secondary|Progression Free Survival (PFS)|PFS is how long patients are likely to live without progression of their disease. It is the time from randomization date to progression date or death date, whichever occurs first.|Up to 10 years||2023-02-28|02/2023||||
2658913|NCT01593254|Secondary|Time to Molecular Response (MR)^4.5|Time to MR^4.5 is how fast patients achieve a deeper response. It is the time between randomization date and first date that MR^4.5 criteria are satisfied.|Up to 10 years||2023-02-28|02/2023||||
2658914|NCT01593254|Secondary|Median Time to Major Molecular Response (MMR)|Time to MMR is how fast patients achieve optimal response. It is the time between randomization date and first date that MMR criteria are satisfied.|Up to 10 years||2023-02-28|02/2023||||
2658915|NCT01593254|Primary|Percentage of Patients Achieving Major Molecular Response (MMR) After 12 Months of CML Treatment|"Major Molecular Response, is defined as a 3-log reduction in BCR-ABL transcripts from the standardized baseline, which represents 100% on the international scale, so a 3-log reduction is fixed at 0.1% for MMR; N/A = not applicable. 95% CI is Clopper-Pearson(Exact) two-sided 95% confidence intervals.~P-value is based on Cochran-Mantel-Haenszel (CMH) test stratified by Sokal score(high, intermediate, low, and unknown) and time between 3 month molecular analysis and randomization (<=4 weeks vs >4 weeks). Month 12 is calculated fro"|At 12 months after Day 1 initiation of 1st line treatment with imatinib or imatinib at any dose, after less than optimal response to first-line imatinib.|All Randomized Participants|||Percentage of Patients||95% Confidence Interval|Number
2658916|NCT01593215|Secondary|Glucose|Plasma glucose will be measure (mMole) in response to an oral glucose tolerance test. Patients will receive the capsules 1 h before the glucose test, and the glucose levels 30 minutes after the oral glucose will be used as a secondary outcome measure. The glucose levels at the highest tolerated dose of yohimbine will be used.|30 minutes after oral glucose|||||||
2658917|NCT01593215|Primary|Insulin Secretion|insulin secretion will be measured (nMole) in response to an oral glucose tolerance test. Patients will receive the capsules 1 h before the glucose test, and the insulin levels 30 minutes after the oral glucose will be used as a primary outcome measure. The insulin levels at the highest tolerated dose of yohimbine will be used.|30 minutes after oral glucose||||% increase of Ins30||95% Confidence Interval|Mean
2658918|NCT01592864|Secondary|Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4|Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the subject was able to tolerate, the less sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached. Change from baseline in tactile response to Week 4 was calculated|Baseline to 4 weeks post administration of study treatment|ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.|||grams||Standard Deviation|Mean
2658919|NCT01592864|Secondary|Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8|"Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10 grams (g) to an upper threshold of 80 g, in increments of 10g since the values below represents adjusted mean change in baseline, the value can fall below scale range. The greater the pressure the subject was able to tolerate, the less. Change from baseline in tactile response to Week 8 was calculated.~sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached."|Baseline to 8 weeks post administration of study treatment|ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.|||grams||Standard Deviation|Mean
2658920|NCT01592864|Secondary|Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4|Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.|Baseline to 4 weeks post administration of study treatment|ITT Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.|||Score on a scale||Standard Deviation|Mean
2658921|NCT01592864|Primary|Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8|Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.|Baseline to 8 weeks post administration of study treatment|Intent to Treat (ITT) Population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy. Missing values were not imputed.|||Score on a scale||Standard Deviation|Mean
2659437|NCT01588496|Secondary|Part A: Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12||Baseline and Week 12|Part A full analysis set|||percent change||Standard Error|Mean
2658922|NCT01592851|Secondary|Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment|"The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity."|Baseline to immediately post treatment administration|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.|||Force (grams)||Standard Deviation|Mean
2658923|NCT01592851|Secondary|Change From Baseline in Tactile Pain Threshold Score at Day 3|"The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity."|Baseline to Day 3|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.|||Force (grams)||Standard Deviation|Mean
2658924|NCT01592851|Secondary|Change From Baseline in Tactile Pain Threshold Score at Day 14|"The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a yes response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity"|Baseline to Day 14|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.|||Force (grams)||Standard Deviation|Mean
2658925|NCT01592851|Secondary|Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3|Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 3. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.|Baseline to Day 3|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.|||Score on a scale||Standard Deviation|Mean
2658926|NCT01592851|Secondary|Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment|Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and immediately after treatment. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.|Baseline to immediately post treatment administration|ITT population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.|||Score on a scale||Standard Deviation|Mean
2658927|NCT01592851|Primary|Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14|Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 14. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.|Baseline to Day 14|Intent To Treat (ITT) population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.|||Score on a scale||Standard Deviation|Mean
2658928|NCT01592799|Secondary|Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever)|This outcome assessed the proportion of influenza like illness (ILI) among household members of children < 15 years with and without laboratory-confirmed influenza.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Percentage of household members||95% Confidence Interval|Number
2659438|NCT01588496|Secondary|Part A: Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Part A full analysis set|||percent change||Standard Error|Mean
2658929|NCT01592799|Secondary|Number of Subjects With Household Members With Influenza-like Illness|This outcome assessed the number of cases with household contacts presenting influenza like illness symptoms during the follow-up period by laboratory-confirmed influenza status.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Household members|||Number
2658930|NCT01592799|Secondary|Number of Days of Parent or Caregiver Time Off Work|This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Days||Standard Deviation|Mean
2658931|NCT01592799|Secondary|Number of Days of School Absenteeism|School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Days||Standard Deviation|Mean
2658932|NCT01592799|Secondary|Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit|ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Participants|||Count of Participants
2658933|NCT01592799|Secondary|Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status|ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Participants|||Count of Participants
2658934|NCT01592799|Secondary|Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status|ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Participants|||Count of Participants
2658935|NCT01592799|Secondary|Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status|ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Participants|||Count of Participants
2658936|NCT01592799|Secondary|Number of Days of Hospitalization|The outcomes was assessed in subjects with laboratory-confirmed influenza status|Day 0 till Day 28-37 (between October 2010 until May 2011)|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Days||Standard Deviation|Mean
2658937|NCT01592799|Secondary|Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status|Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Participants|||Count of Participants
2658938|NCT01592799|Secondary|Number of Subjects With Secondary Bacterial Infections|The outcome assessed the various complications by laboratory-confirmed influenza status.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Participants|||Count of Participants
2658939|NCT01592799|Secondary|Number of Subjects With Fatal Outcomes|Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Participants|||Count of Participants
2658940|NCT01592799|Secondary|Number of Subjects With Other Laboratory-confirmed Respiratory Viruses|Among the other laboratory-confirmed respiratory viruses there were:adenovirus, respiratory syncytial virus, parainfluenza virus 1, 2 and 3, metapneumovirus, bocavirus, rhinovirus or coronavirus. The outcome was assessed in subjects with an acute respiratory illness (ARI) and/or isolated fever episode.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Participants|||Count of Participants
2658995|NCT01592396|Primary|Time to Reach Maximum Observed Serum Concentration (Tmax)||0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|Pharmacokinetic (PK) population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.|||days||Full Range|Median
2658941|NCT01592799|Primary|Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza|Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available and who were hospitalized or visited an emergency room.|||Euros||Standard Deviation|Mean
2658942|NCT01592799|Primary|Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever|ARI was defined as one or more of the following symptoms: sore throat (in children greater than or equal to (≥) 3 years old), coryza (runny nose), cough, breathing difficulties. Isolated fever was defined as: oral temperature ≥37.5°C / axillary temperature ≥37.5°C / Rectal temperature ≥38°C / tympanic temperature on oral setting ≥37.5°C / tympanic temperature on rectal setting ≥38°C without an obvious cause.|Day 0 till Day 28-37|The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available.|||Participants|||Count of Participants
2658943|NCT01592786|Primary|Number of Confirmed Social Responsiveness Scale (SRS) Responders|"A confirmed SRS responder was defined as a patient who had at least 12 weeks of exposure to memantine, and a ≥ 10-point reduction in the SRS total raw score relative to baseline at 2 consecutive visits separated by at least 2 weeks.~The SRS is a 65-item, caregiver-rated assessment scale that measures observable items on social behavior and social language use, as well as characteristics of autism in a naturalistic social setting. Each item is rated on a scale from 0 (never true) to 3 (almost always true). The SRS total raw score ranges from 0 to 195; a higher score indicates greater severity of social impairment."|Visit 1 (Baseline) to Visit 8 (week 48/Final Visit)|Of the 906 patients who enrolled in the study 903 received at least 1 dose of open-label treatment to comprise the Safety Population. The Intent to Treat (ITT) population included the 868 patients in the Safety population who also had at least 1 post–Visit 1 assessment of the SRS total raw score.|||participants|||Number
2658944|NCT01592773|Primary|Patients With Any Treatment-emergent Adverse Event|Number of patients who experienced 1 or more Treatment Emergent Adverse Event|Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit|Analysis was performed on the 747 patients who took at least 1 dose of investigational product (Safety Population).|||participants|||Number
2658945|NCT01592760|Secondary|Oropharyngolaryngeal Morbidity at 24 Hours Post-operatively|Perioperative oropharyngolaryngeal morbidity is assessed by the subject's response to standardized questions regarding oropharyngeal complaints.|Measured at 24 hours after device placement/study initiation||||participants|||Number
2658946|NCT01592760|Secondary|Oropharyngolaryngeal Morbidity at Discharge|Perioperative oropharyngolaryngeal morbidity is assessed by the subject's response to standardized questions regarding oropharyngeal complaints.|Measured prior to discharge from phase II of the post-anesthesia care unit/recovery room||||participants|||Number
2658947|NCT01592760|Secondary|Overall Clinical Usefulness|Excellent, good, fair, or inadequate. Scale defined by clinical measures and observations.|Reported by the device operator at the time of device removal||||participants|||Number
2658948|NCT01592760|Secondary|Incidence of Oropharyngeal Injury|Oropharyngeal injury is defined as a new lip, tongue, buccal, or pharyngeal abrasion or laceration or dental damage observed in the immediate recovery area after use of a study device.|Measured in the post-anesthesia care unit/recovery room within 15 minutes after device removal||||participants|||Number
2658949|NCT01592760|Secondary|Incidence of Gastric Aspiration|Gastric aspiration is present when gross gastric contents or bile is observed on or within the device or within the subject's oropharynx. The outcome is the proportion of study subjects in whom the outcome measure was observed.|Measured between successful device placement and device removal for any reason.||||participants|||Number
2658950|NCT01592760|Secondary|Incidence of Gastric Insufflation|Gastric insufflation is present when audible air sounds are heard by stethoscope over the subject's epigastrium.|Measured within 5 minutes of device placement/study initiation||||participants|||Number
2658951|NCT01592760|Secondary|Device Use Time (Min)|Device Use Time is the time recorded to the nearest minute of the period bounded by the time the device placement was determined to be adequate in the study subject to its withdrawal from the study subject.|Measured between successful device placement and device removal for any reason, approximately 2 hours||||minutes||Standard Deviation|Mean
2658952|NCT01592760|Secondary|Device Position in Relation to the Vocal Cords|Device position in relation to the vocal cords is assessed with a flexible fiberoptic camera and graded as follows: 1 = full view of the vocal cords, 2 = partial view of the vocal cords including the arytenoids, 3 = view of the epiglottis only, and 4 = other (device cuff, pharynx or other structures).|Measured within 5 minutes of successful study device placement||||participants|||Number
2658953|NCT01592760|Secondary|Device Ease of Insertion|Device ease of insertion is graded as either easy, slightly difficult, difficult, or impossible. The outcome measure is the proportion of successful study device placements recorded as easy versus slightly difficult versus difficult versus impossible.|Reported by the device operator at the time successful device placement is recorded.||||participants|||Number
2658954|NCT01592760|Secondary|Device Placement Success Rate|Device placement success rate is defined as the proportion of devices successfully placed within three attempts at device placement.|Measured at the time of attempted study device placement immediately after the induction of general anesthesia||||participants|||Number
2658955|NCT01592760|Secondary|Device Placement Time|Device placement time is the time measured in seconds from when the study investigator picks up the airway device to confirmation of ventilation by the presence of an adequate end-tidal carbon dioxide tracing on the monitor.|Measured at device placement/study initiation||||seconds||Standard Deviation|Mean
2658956|NCT01592760|Primary|Airway Seal Pressure After Device Placement|Airway seal pressure is defined as the pressure in cmH2O at which the needle of a manometer attached to the anesthesia circuit reaches equilibration, associated with an audible air leak from the subject's oropharynx or gastric insufflation, limited to a maximum pressure of 40 cmH2O. It is measured with the subject's head and neck in neutral position, the expiratory valve on the anesthesia machine closed, and the fresh gas flow set to five liters per minute.|Measured within 5 minutes after device placement/study initiation||||cmH2O||Standard Deviation|Mean
2658957|NCT01592747|Secondary|Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Interests Subscale at Week 12|The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. The Children's Communication Checklist-2 (CCC-2) Interests Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).|Baseline (Visit 1) to week 12|Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).|||units on a scale||Standard Error|Least Squares Mean
2658958|NCT01592747|Secondary|Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Social Relations Subscale at Week 12|The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. The Children's Communication Checklist-2 (CCC-2) Social Relations Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).|Baseline (Visit 1) to week 12|Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).|||units on a scale||Standard Error|Least Squares Mean
2658959|NCT01592747|Secondary|Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale at Week 12|The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. The Children's Communication Checklist-2 (CCC-2) Nonverbal communication Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).|Baseline (Visit 1) to week 12|Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).|||units on a scale||Standard Error|Least Squares Mean
2658960|NCT01592747|Secondary|Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Context Subscale at Week 12|The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. The Children's Communication Checklist-2 (CCC-2) Context Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).|Baseline (Visit 1) to week 12|Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).|||units on a scale||Standard Error|Least Squares Mean
2658961|NCT01592747|Secondary|Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Scripted Language Subscale at Week 12|The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. The Children's Communication Checklist-2 (CCC-2) Scripted language Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).|Baseline (Visit 1) to week 12|Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).|||units on a scale||Standard Error|Least Squares Mean
2658962|NCT01592747|Secondary|Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale at Week 12|The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. The Children's Communication Checklist-2 (CCC-2) Initiation Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).|Baseline (Visit 1) to week 12|Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).|||units on a scale||Standard Error|Least Squares Mean
2658963|NCT01592747|Secondary|Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale at Week 12|The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. The Children's Communication Checklist-2 (CCC-2) Coherence Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).|Baseline (Visit 1) to week 12|Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).|||units on a scale||Standard Error|Least Squares Mean
2658964|NCT01592747|Secondary|Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale at Week 12|The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. The Children's Communication Checklist-2 (CCC-2) Semantics Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).|Baseline (Visit 1) to week 12|Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).|||units on a scale||Standard Error|Least Squares Mean
2659096|NCT01591681|Secondary|Percentage of Nights With a Sensor Glucose Value </= 70 mg/dL||Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use||||percentage of nights|Participants||Number
2658965|NCT01592747|Secondary|Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale at Week 12|The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. The Children's Communication Checklist-2 (CCC-2) Syntax Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).|Baseline (Visit 1) to week 12|Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).|||units on a scale||Standard Error|Least Squares Mean
2658966|NCT01592747|Secondary|Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Speech Subscale at Week 12|The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties (items 1-50) and strengths (items 51-70) in communication. There are 10 sub-scales consisting of 7 items each. The Children's Communication Checklist-2 (CCC-2) Speech Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).|Baseline (Visit 1) to week 12|Of the 479 randomized patients, 471 patients were included in the Intent to Treat (ITT) Population. Within the ITT population, 466 patients had post-baseline assessment of the Children's Communication Checklist-2 (CCC-2).|||units on a scale||Standard Error|Least Squares Mean
2658967|NCT01592747|Secondary|Time to First Loss of Therapeutic (LTR) Response|Time to the first visit when a patient shows LTR following randomization to memantine or placebo.|Baseline to week 12|All efficacy analyses were based on the Intent-to-treat (ITT) Population. Of the 479 randomized patients, 471 patients were in the ITT Population (ie, had at least 1 dose of double-blind investigational product and at least 1 assessment of the Social Responsiveness Scale (SRS) total raw score during the double-blind treatment period.)|||Days||95% Confidence Interval|Median
2658968|NCT01592747|Primary|Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases)|Loss of Therapeutic response is defined as a worsening (increase) of at least 10 points in Social Responsiveness Scale (SRS) total raw score relative to the Visit 1 (randomization) score. The Social Responsiveness Scale (SRS) is a 65-item informant-rated assessment with total raw score ranging from 0 (no impairment) to 195 (severe social impairment). Each item is associated with 1 of 5 subscales (social awareness, social cognition, social communication, social motivation and autistic mannerisms). Each item is rated on a 4-point scale from 1 (not true) to 4 (almost always true). The scores are then transposed to a scale from 0 to 3 and scores are summed within each of the 5 subscales. A higher score indicates greater severity of social impairment.|Baseline (Visit 1) to week 12|All efficacy analyses were based on the Intent-to-treat (ITT) Population. Of the 479 randomized patients, 471 patients were in the ITT Population (ie, had at least 1 dose of double-blind investigational product and at least 1 assessment of the Social Responsiveness Scale (SRS) total raw score during the double-blind treatment period.)|||Percentage of patients with LTR|||Number
2658969|NCT01592708|Secondary|Post-discharge Vomiting||1 week post discharge|This analysis only possible with patients who successfully completed the post-discharge diary. Therefore, the participant number differs from the total patients enrolled.|||percentage of subjects with PDV|||Number
2658970|NCT01592708|Primary|Post-operative Vomiting||End of surgery to discharge from hospital||||percentage of subjects with POV|||Number
2658971|NCT01592708|Secondary|Post-discharge Nausea|To be assessed based on patient diary completed daily for 1 week following discharge to home from the hospital|1 week from discharge from hospital|This analysis only possible with patients who successfully completed the post-discharge diary. Therefore, the participant number differs from the total patients enrolled.|||percentage of subjects with PDN|||Number
2658972|NCT01592708|Secondary|Hospital Length of Stay|Anesthesia start time determined from anesthesia portion of the medical record. Time at which discharge order was placed will serve as time of discharge.|Anesthesia start time to placement of hospital discharge order - average 26 - 28 hours||||hours||Inter-Quartile Range|Median
2658973|NCT01592708|Primary|Post-operative Nausea|End of surgery time determined by anesthesia portion of the medical record. PONV to be assessed by review of surgeons' and nurses' notes in the medical record as well as through review of patient diaries. Vomiting constitutes a safety issue and, as such, associated adverse events will be noted.|End of surgery to discharge from hospital||||percentage of subjects with PON|||Number
2658974|NCT01592695|Secondary|Treatment Attendance|The number of treatment calls completed (out of six total) will be calculated for all participants in the Tailored Intervention group as an indicator of the feasibility of the treatment approach.|End of treatment (seven weeks after baseline)|Attendance rate (number of counseling calls completed out of 6) among those assigned to the tailored intervention condition.|||Calls||Full Range|Mean
2658975|NCT01592695|Secondary|Retention|The number of participants who remain in the study throughout the seven-week treatment period will be computed as an indicator of the feasibility of the treatment approach.|End of treatment (seven weeks after baseline)|Participants assigned to the tailored intervention condition who completed the intervention calls.|||Participants|||Count of Participants
2658976|NCT01592695|Secondary|Enrollment Rate|The number of participants enrolled will be tracked as a measure of the feasibility of the intervention approached for the entire six-month recruitment period.|6 months after study initiation|Total number of participants randomized to each treatment condition.|||Participants|||Count of Participants
2658977|NCT01592695|Secondary|Body Weight|Self-reported body weight.|Six-month follow-up|Assessed among participants in the tailored intervention group who received the weight management module and those in the enhanced standard of care condition who would have been eligible for the weight management module if they had been assigned to the tailored intervention condition.|||Pounds||Standard Deviation|Mean
2658978|NCT01592695|Secondary|Depressive Symptoms|Depressive symptoms as measured using the Patient Health Questionnaire 9 (PHQ-9). Possible scores range from 0 to 27, with higher scores indicating greater levels of depressive symptoms.|Six-month follow-up|Participants in the tailored intervention group who receive the mood management module and those in the enhanced standard of care condition who would have been eligible for the mood management module if they had been assigned to the tailored intervention condition.|||units on a scale||Standard Deviation|Mean
2658979|NCT01592695|Secondary|Alcohol Use|Alcohol use during the previous seven days will be assessed among those receiving the risky alcohol use treatment module and those in the quitline referral condition who would have been eligible for the intervention if assigned to the tailored treatment group.|Six-month follow-up|Participants in the tailored intervention group who received the alcohol intervention and those in the enhanced standard of care group who would have been eligible for the alcohol intervention if they had been assigned to the tailored intervention group.|||Drinks consumed per day||Standard Deviation|Mean
2658980|NCT01592695|Secondary|Number of Participants Abstinent From Tobacco Use|At the six-month follow-up contact, participants will be questioned regarding self-reported tobacco use over the past seven days (point prevalence abstinence).|Six-month follow-up|7-day point prevalence abstinence at 6 months. Those with missing data treated as smokers (penalized imputation).|||Participants|||Count of Participants
2658981|NCT01592695|Primary|Treatment Satisfaction|Participants' impressions of and satisfaction with the intervention will be assessed by interview at the end of treatment.|End of treatment (seven weeks after baseline)|Participants who completed treatment satisfaction items on three-month follow-up|||Participants|||Count of Participants
2658982|NCT01592500|Secondary|Change in IGF-1 Standard Deviation Score|Change in IGF-1 standard deviation score from reference population mean of same age group and sex (WHO source). IGF-1 SDS was calculated as IGF-1 result minus reference mean IGF-1 result divided by SD of the reference mean IGF-1 value.|Once monthly on day 4 after the last dose|No data were scheduled to be collected for Week 23 in the Genotropin Arm/Group|||score on a scale||Standard Deviation|Mean
2658983|NCT01592500|Secondary|Change in Height Standard Deviation Score (SDS)|Change in height standard deviation score from baseline (compared to normal population of same age group and sex). Height SDS was calculated as height minus reference mean height divided by SD of the reference mean height|After 6 and 12 months of treatment|Per Protocol Population|||score on a scale||Standard Deviation|Mean
2658984|NCT01592500|Secondary|Height Velocity at 6 Months|Annualized Height Velocity in cm/year measured after 6 months of treatment|After 6 months of treatment|Per Protocol Population|||cm/year||Standard Deviation|Mean
2658985|NCT01592500|Primary|Annual Height Velocity|Annual Height Velocity in cm/year measured after 12 months of treatment|12 months of treatment|Per Protocol Population|||cm/year||Standard Deviation|Mean
2658986|NCT01592435|Primary|Radlex Scale for Diagnostic Capability Ratings - Carestream DR LLI Software (Investigational)|1-Non-diagnostic - Unacceptable for diagnostic purposes. 2-Limited - Acceptable, with some technical defect. 3-Diagnostic - Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary - Good, most adequate for diagnostic purposes.|5 weeks after completion of data collection||||units on a scale||Standard Error|Mean
2658987|NCT01592435|Primary|Radlex Scale for Diagnostic Capability Ratings - Cedara Accustitch Software (Predicate)|1-Non-diagnostic - Unacceptable for diagnostic purposes. 2-Limited - Acceptable, with some technical defect. 3-Diagnostic - Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary - Good, most adequate for diagnostic purposes.|5 weeks after completion of data collection||||units on a scale||Standard Error|Mean
2658988|NCT01592409|Primary|Psychomotor Impairment (Driving)|The driving simulator will objectively measure driving behaviour during a number of pre-programmed driving scenarios. Zone/ Hazard performance measure: Mean Speed.|Approximate: at baseline (30 minutes before smoking), 30 minutes after smoking|Zone/Hazard performance measure: Mean Speed (Change from drug-free baseline to 30 minutes after smoking cannabis in kilometres per hour (kph)|||change in kph||Standard Deviation|Mean
2658989|NCT01592396|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit|Immunogenicity assessment included determination of anti-drug antibodies to tralokinumab (CAT-354) antibodies in serum samples. Immunogenicity results were summarized together for all participants.|Day 1 and Day 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.|||participants|||Number
2658990|NCT01592396|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Day 57 that were absent before treatment or that worsened relative to pre-treatment state. Adverse events were summarized together for all participants.|Day 1 to Day 57|Safety population included all participants who received investigational product.|||participants|||Number
2658991|NCT01592396|Primary|Terminal Phase Elimination Half Life (t1/2)|Terminal phase elimination half-life is the time measured for the serum concentration to decrease by one half.|0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.|||days||Standard Deviation|Mean
2658992|NCT01592396|Primary|Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t])||0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.|||mcg*day/mL||Standard Deviation|Mean
2658993|NCT01592396|Primary|Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity])|AUC (0 - infinity) = Area under the serum concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).|0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.|||(microgram*day)/milliliter (mcg*day/mL)||Standard Deviation|Mean
2658994|NCT01592396|Primary|Maximum Observed Serum Concentration (Cmax)||0 (predose), 3, 8 and 24 hours postdose on Day 1; Day 4, 6, 8, 10, 15, 22, 36 and 57|PK population included all participants who received the investigational product and had at least 1 detectable post dosing tralokinumab (CAT-354) serum concentration.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2658997|NCT01592383|Secondary|Disease Control Rate - SD + PR + CR|Disease Control Rate - SD + PR + CR is calculated as the percentage of patients with either complete response (CR: disappearance of all target lesions), or with partial response (PR: at least 30% decrease in the sum of longest diameter of target lesions, taking as reference the baseline sum longest diameter of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease of an increase of at least 20% in the sum of the longest diameter of the target lesions taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions).|1 year|The study was terminated early after the enrollment of two participants and the data were not collected.||||||
2658998|NCT01592383|Secondary|Toxicity|Toxicity is calculated in terms of adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) criteria version 4.0|30 days from the last dose of study drug|The study was terminated early after the enrollment of two participants and the data were not collected.||||||
2658999|NCT01592383|Secondary|OS|Overall survival measured as the time from study enrollment until death.|1 year|The study was terminated early after the enrollment of two participants and the data were not collected.||||||
2659000|NCT01592383|Secondary|PFS|Progression free survival (PFS) defined as time from study enrollment until disease progression or death.|1 year|The study was terminated early after the enrollment of two participants and the data were not collected.||||||
2659001|NCT01592383|Primary|Objective Response Rate|Objective Response Rate is calculated according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1|1 year|The study was terminated early after the enrollment of two participants and the data were not collected.||||||
2659002|NCT01592344|Secondary|Patient Satisfaction Will be Assessed Using a Patient Satisfaction Survey|Patient satisfaction with the StimRouter System was rated on a numerical rating scale (range 0 to 10), with 0 indicating not satisfied at all and 10 indicating completely satisfied.|at the 3-month follow-up|All subjects who completed the survey at Month 3 were included in this analysis. Four subjects in each study arm (4/45 Treatment; 4/49 Control) failed to complete the satisfaction survey.|||units on a scale||Standard Deviation|Mean
2659003|NCT01592344|Secondary|Worst Pain in the Last 24 Hours Will be Assessed Using 7-day Patient Pain Diary Scores for BPI SF #3.|"Worst pain in the last 24 hours assessed using 7-day patient pain diary scores for BPI ranging from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine. Change from baseline to Month 3 was compared."|at baseline and 3 month follow-up|All available data were analyzed from both treatment arms.|||units on a scale||Standard Deviation|Mean
2659004|NCT01592344|Secondary|Patient Global Impression of Improvement With Treatment Will be Assessed Using the Patient Global Impression of Change Scale (PGIC).|Patient Global Impression of Change in activity limitations, symptoms, emotions and overall life quality related to their painful condition (Range 1 to 7, with 1 indicating no change and 7 indicating a great deal better/considerable improvement).|at 3 month follow-up|All patients who completed the 3 month Global Impression of Change questionnaire were included. Four patients in each study arm failed to complete the questionnaire.|||units on a scale||Standard Deviation|Mean
2659005|NCT01592344|Primary|Brief Pain Inventory (BPI): Number of Participants With a Pain Reduction of Greater Than or Equal to 30%|The average pain at rest was assessed using a numerical (0-10) rating scale (NRS) on the Brief Pain Inventory (BPI) Short Form (SF). A higher score indicates worse pain (10=worst pain imaginable) and zero indicates 'no pain at all'. A pain reduction of greater than or equal to 30% on the NRS was considered to be clinically relevant.|Baseline and at 3-month follow-up.|Intent to treat (ITT) population was analyzed.|||participants|||Number
2659006|NCT01592292|Secondary|Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|Baseline up to Month 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria.|||participants|||Number
2659007|NCT01592292|Secondary|Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS)|The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.|Month 6|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here number of participants analyzed is the total participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2659008|NCT01592292|Secondary|Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population|The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.|Month 6|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here number of participants analyzed is the total participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2659266|NCT01589978|Secondary|Target Vessel Revascularization (TVR) Rate|Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
2659009|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS)|CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.|Baseline, Month 6 and 12|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.|||mg/dL||Standard Deviation|Mean
2659010|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population|CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.|Baseline, Month 6 and 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
2659011|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS)|ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.|Baseline, Month 6 and 12|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.|||mm/hr||Standard Deviation|Mean
2659012|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population|ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.|Baseline, Month 6 and 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.|||millimeter/hour (mm/hr)||Standard Deviation|Mean
2659013|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS)|SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).|Baseline, Month 6 and 12|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.|||number of swollen joints||Standard Deviation|Mean
2659014|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population|SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).|Baseline, Month 6 and 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.|||number of swollen joints||Standard Deviation|Mean
2659015|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS)|TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).|Baseline, Month 6 and 12|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.|||number of tender joints||Standard Deviation|Mean
2659016|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population|TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).|Baseline, Month 6 and 12|The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.|||number of tender joints||Standard Deviation|Mean
2659017|NCT01592292|Secondary|Efficacy: Mean Change From Baseline in DAS28 at Month 12|DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Month 12|Analysis was performed on participants who were administered with secondary biological agent continuously without change or suspension for 12 months. Here, 'n' represents the participants who were evaluable at specific time point.|||units on a scale||Standard Deviation|Mean
2659018|NCT01592292|Primary|Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS)|DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Month 6|The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set.|||units on a scale||Standard Deviation|Mean
2659019|NCT01592292|Primary|Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population|DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Month 6|The ITT set included participants who offered end-point results among participants who received study drugs after enrollment and met all inclusion/exclusion criteria.|||units on a scale||Standard Deviation|Mean
2659020|NCT01592240|Secondary|Percentage of Participants With Low Density Lipoprotein-cholesterol Less Than (<) 100, <70, <40 and <25 Milligram Per Deciliter (mg/dL)||Week 12, 24|"FAS included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percentage of participants|||Number
2659021|NCT01592240|Secondary|Plasma Concentration of PF-04950615 at Week 12 and 24||Week 12, 24|"Analysis set included all participants who received at least 1 dose of PF-04950615. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||Microgram per milliliter||Standard Deviation|Mean
2659022|NCT01592240|Secondary|Percentage of Participants With Injection Site Adverse Events|Injection site adverse events included injection site bruising, discomfort, erythema, hemorrhage, induration, inflammation, pain, paresthesia, pruritus, swelling, urticaria, reaction and rash.|Baseline up to Day 211 for 28 days groups and Baseline up to Day 225 for 14 days groups|Safety analysis set included all participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
2659023|NCT01592240|Secondary|Percentage of Participants With Positive Anti-drug (Anti-PF-04950615) Antibodies (ADA)|Participants with titer value greater than or equal to 4.32 nanogram per milliliter were considered positive.|Baseline up to Day 211 for every 28 days groups and Baseline up to Day 225 for every 14 days groups|Analysis set included all participants who received at least 1 dose of PF-04950615.|||percentage of participants|||Number
2659024|NCT01592240|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||Standard Deviation|Mean
2659025|NCT01592240|Secondary|Change From Baseline in Non-High Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||milligram per deciliter||Standard Deviation|Mean
2659026|NCT01592240|Secondary|Percent Change From Baseline in Triglycerides at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||Standard Deviation|Mean
2659027|NCT01592240|Secondary|Change From Baseline in Triglycerides at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||milligram per deciliter||Standard Deviation|Mean
2659028|NCT01592240|Secondary|Percent Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||Standard Deviation|Mean
2659029|NCT01592240|Secondary|Change From Baseline in Very Low Density Lipoprotein (VLDL) Cholesterol at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||milligram per deciliter||Standard Deviation|Mean
2659030|NCT01592240|Secondary|Percent Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||Standard Deviation|Mean
2659031|NCT01592240|Secondary|Change From Baseline in Lipoprotein (a) (Lp [a]) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||milligram per deciliter||Standard Deviation|Mean
2659032|NCT01592240|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||Standard Deviation|Mean
2659033|NCT01592240|Secondary|Change From Baseline in Total Cholesterol at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||milligram per deciliter||Standard Deviation|Mean
2659034|NCT01592240|Secondary|Percent Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||95% Confidence Interval|Mean
2659035|NCT01592240|Secondary|Change From Baseline in Apolipoprotein AII (ApoAII) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||milligram per deciliter||95% Confidence Interval|Mean
2659036|NCT01592240|Secondary|Percent Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||95% Confidence Interval|Mean
2659037|NCT01592240|Secondary|Change From Baseline in Apolipoprotein A1 (ApoA1) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||milligram per deciliter||95% Confidence Interval|Mean
2659038|NCT01592240|Secondary|Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||95% Confidence Interval|Mean
2659039|NCT01592240|Secondary|Change From Baseline in Apolipoprotein B (ApoB) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||milligram per deciliter||95% Confidence Interval|Mean
2659040|NCT01592240|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||95% Confidence Interval|Mean
2659041|NCT01592240|Secondary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||milligram per deciliter||95% Confidence Interval|Mean
2659042|NCT01592240|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 and 24||Baseline, Week 12, 24|"Full analysis set included all participants who were randomized. Here, Number Analyzed signifies number of participants evaluable at specified time points."|||percent change||95% Confidence Interval|Mean
2659043|NCT01592240|Secondary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 24||Baseline, Week 24|"Full analysis set included all participants who were randomized. Here Overall Number of Participants Analyzed, signifies number of participants those who were evaluable for this outcome measure."|||milligram per deciliter||95% Confidence Interval|Mean
2659044|NCT01592240|Primary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12||Baseline, Week 12|"Full analysis set included all participants who were randomized. Here Overall Number of Participants Analyzed, signifies number of participants those who were evaluable for this outcome measure."|||milligram per deciliter (mg/dL)||95% Confidence Interval|Mean
2659045|NCT01592071|Primary|Waist-Hip Ratio (WHR)|Measure of body composition: hip and waist circumference to calculate waist/hip ratio (WHR).|30, 60 or 90 days from baseline||||ratio||Standard Deviation|Mean
2659046|NCT01592071|Primary|Hip Circumference|Measure of body composition: hip circumference (cm).|30, 60 or 90 days from baseline||||centimeters||Standard Deviation|Mean
2659047|NCT01592071|Secondary|Quality of Life|Quality of life categories measured with the SF-36 Health Survey. The SF-36 Health Survey provides psychometrically-based physical and mental health summary measures and a preference-based health utility index.The SF-36 provides a t-score for each scale or domain ranging from 0-100 with higher scores representing better perceived quality of life.|30, 60 or 90 days from baseline||||Scores on a scale||Standard Deviation|Mean
2659048|NCT01592071|Secondary|Heart Rate|Heart rate measured.|30, 60 and 90 days from baseline||||bpm||Standard Deviation|Mean
2659049|NCT01592071|Primary|Waist Circumference|Measure of body composition: waist circumference (cm).|30, 60 and 90 days from baseline||||centimeters||Standard Deviation|Mean
2659050|NCT01592071|Primary|Body Mass Index|Measure of body composition: height and weight to assess BMI.|30, 60 and 90 days from baseline||||kg/m^2||Standard Deviation|Mean
2659051|NCT01592071|Secondary|Blood Pressure|Systolic and diastolic blood pressure measured.|30, 60 and 90 days from baseline||||mm Hg||Standard Deviation|Mean
2659052|NCT01592071|Primary|Weight (kg)|Measure of body composition: weight (kg).|30, 60 and 90 days from baseline||||kilograms||Standard Deviation|Mean
2659053|NCT01592045|Primary|Peak Plasma Concentration (Cmax)|"Twenty-two PK samples will be obtained at the following timepoints:~Courses 1 and 3:~Day: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample~Courses 2 and 4:~Day 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin"|PK samples obtained during Courses 1 and 3: Days 0, 3, 4, 5, 6, 7, 9, 10, 11, 14, 15, 16, 17; PK samples obtained during Courses 2 and 4: Days 0, 7, 10; End of Treatment||||ng/mL||Standard Deviation|Mean
2659054|NCT01592045|Primary|Area Under the Plasma Concentration Curve (AUC)|"Twenty-two PK samples will be obtained at the following timepoints:~Courses 1 and 3:~Day: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample~Courses 2 and 4:~Day 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin"|PK samples obtained during Courses 1 and 3: Days 0, 3, 4, 5, 6, 7, 9, 10, 11, 14, 15, 16, 17; PK samples obtained during Courses 2 and 4: Days 0, 7, 10; End of Treatment||||mcg*hr/mL||Standard Deviation|Mean
2659055|NCT01592006|Secondary|Safety of Triple Antiviral Therapy in HCV Infected OLT Recipients|Tolerability and Safety will be measured and reported by serious adverse events.|6 years from the start of the study||||participants|||Number
2659056|NCT01592006|Primary|The Efficacy of Triple Antiviral Therapy|To evaluate the efficacy of triple antiviral therapy, consisting of pegylated interferon alfa-2a (Pegasys®), ribavirin, and telaprevir therapy in liver transplant recipients with hepatitis C. This will be measured and reported by sustained virologic response (defined as undetectable HCV RNA in the blood 24 weeks after completing therapy [SVR24])|3 years from start of study||||percentage of participants|||Number
2659057|NCT01591954|Secondary|Data Recording for Retrospective Analysis|"The secondary outcome variable of this study is the data recorded by the video augmentation system during pertinent portions of the operation. We will be targeting steps in the procedure that would have the greatest benefit from an augmented video scene to be used later for further studies. Such data will form the subject of retrospective analysis of workflow.~Three sets of data will be collected to be able to reconstruct the video scene for analysis of the system:~- Tracked Endoscope information.~- Video from endoscopy~- Planning CT/MRI data"|Data is recorded during case.|The study was terminated following 1 subject accrual. The system encountered basic software incompatibility and would not function reliably. The problem could not be resolved even with extensive technical troubleshooting, so the study was terminated. Data was collected for one participant but could not be analyzed due to software incompatibility.||||||
2659279|NCT01589926|Secondary|Difference in Respiratory Rate.||48hrs after initiation of treatment|Study was terminated due to low enrollment. Only three participants were enrolled and none initiated treatment.||||||
2659058|NCT01591954|Primary|Qualitative Assessment of Video Augmentation Software by Post-operative Survey of Neurosurgeon and Otolaryngologist|"The qualitative assessment of new video augmentation software by the three surgeons surveys the effect of video augmentation overlay on overall surgical confidence, procedure, approach, and visualization.~= Significant hindrance / Negative effect;~= Minor hindrance / Slightly negative effect;~= Not helpful / No benefit or hindrance;~= Somewhat helpful / Slight benefit;~= Very helpful / Major benefit. Evaluation of safety is determined by collecting data regarding additional time, personnel and possible contamination."|Assessment is immediate, following operation.|The study was terminated following 1 subject accrual. The system encountered basic software incompatibility and would not function reliably. The problem could not be resolved even with extensive technical troubleshooting, so the study was terminated. Data was collected for one participant but could not be analyzed due to software incompatibility.||||||
2659059|NCT01591863|Primary|Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.|End of therapy fecal levels of OP-1118 (mean)|End of Therapy; Day 10-11|Treated subjects with evaluable fecal data|||microgram/g||Standard Deviation|Mean
2659060|NCT01591863|Primary|Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.|3-5 hour plasma levels of OP-1118 (mean)|3-5 hours after administration|Treated subjects with evaluable plasma pharmacokinetic data|||ng/mL||Standard Deviation|Mean
2659061|NCT01591863|Secondary|Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response.|Positive clinical response without recurrence through the follow-up period|28 days post-treatment|Treated subjects with positive toxin assay result within 24 hours of enrollment|||percentage of participants||95% Confidence Interval|Number
2659062|NCT01591863|Secondary|Evaluate the Clinical Outcome by Assessment of Clinical Response.|Positive clinical response defined as resolution of diarrhea|Day 10|Treated subjects with positive toxin assay result within 24 hours of enrollment|||percentage of subjects||95% Confidence Interval|Number
2659063|NCT01591863|Primary|Investigate Concentrations of Fidaxomicin in Fecal Samples.|End of therapy fecal levels of fidaxomicin (mean)|End of Therapy; Day 10-11|Treated subjects with evaluable fecal data|||microgram/g||Standard Deviation|Mean
2659064|NCT01591863|Primary|Investigate Concentrations of Fidaxomicin in Plasma Samples.|3-5 hour plasma levels of fidaxomicin (mean)|3-5 hours after administration|Treated subjects with evaluable plasma pharmacokinetic data|||ng/mL||Standard Deviation|Mean
2659065|NCT01591863|Primary|Number of Participants With Adverse Events.|Number of participants with adverse events, as categorized by MedDRA.|Enrollment through end of study (Day 38-41)|Subjects receiving any amount of study drug|||participants|||Number
2659066|NCT01591837|Secondary|Frequency of Any Unsolicited AEs.|The percentage of participants reporting any unsolicited AEs. Unsolicited AEs included AEs other than those specifically solicited.|After vaccination until the end of the study; approximately 21 days|The Safety Population included all participants who received CSL Influenza Vaccine and provided follow-up safety data.|||percentage of participants|||Number
2659067|NCT01591837|Secondary|Frequency and Intensity of Any Solicited Adverse Events (AEs).|"The percentage of participants reporting any solicited AEs and the percentage of participants reporting any solicited AEs with severe intensity. Note: Intensity of solicited AEs was collected for temperature only.~Solicited local AEs collected included induration >50 mm, erythema, ecchymosis, and pain at the vaccination site.~Solicited systemic AEs collected included temperature above 38.0°C, chills, and malaise.~Solicited AE intensity grading: Mild: symptoms were easily tolerated and there was no interference with daily activities; Moderate: enough discomfort to cause some interference with daily activities; Severe: symptoms that prevented normal, everyday activities."|During the 4 days after vaccination (Day 0 plus 3 days)|The Safety Population included all participants who received CSL Influenza Vaccine and provided follow-up safety data.|||percentage of participants|||Number
2659068|NCT01591837|Primary|The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.|For the H1N1, H3N2, and B influenza virus strains. Note: No SRH data were collected.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with CSL Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.|||percentage of participants||95% Confidence Interval|Number
2659069|NCT01591837|Primary|The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.|GMFI (H1N1, H3N2, and B influenza virus strains) was defined as the geometric mean of the fold increases of post-vaccination antibody titre over the pre-vaccination antibody titre.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with CSL Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.|||geometric mean fold increase||95% Confidence Interval|Geometric Mean
2659070|NCT01591837|Primary|The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.|As per the criteria specified in the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines. For haemagglutination inhibition (HI), seroconversion (H1N1, H3N2, and B influenza virus strains) was defined as achieving a post-vaccination titre of ≥ 40 for those participants with a pre-vaccination HI titre of < 10. A significant increase (H1N1, H3N2, and B influenza virus strains) was defined as a four-fold or greater increase in HI titre for those participants with a pre-vaccination HI titre of ≥ 10.|Approximately 21 days after vaccination|The Evaluable Population included all participants who were vaccinated with CSL Influenza Vaccine, provided both pre- and post-vaccination antibody titer results, did not use a prohibited medication as per the protocol, and were not excluded from the analysis according to the elimination criteria.|||percentage of participants||95% Confidence Interval|Number
2659071|NCT01591746|Secondary|Rate of Reconstruction Failure|The rate of reconstruction failure will be measured by the number of subjects who have tissue expander removal.|6 months after first surgery||||Participants|||Count of Participants
2659072|NCT01591746|Secondary|Total Volume of Tissue Expansion|Measurement of total expansion volume in milliliters (mL).|Up to 24 weeks post-operatively|Volume measurement were not captured on all subjects.|||mL||Inter-Quartile Range|Median
2659073|NCT01591746|Secondary|Number of Tissue Expansion Visits|The total number of tissue expansion visits completed post-operatively.|up to 24 weeks post-operatively||||visits||Inter-Quartile Range|Median
2659074|NCT01591746|Secondary|Initial Intraoperative Fill Volume in Milliliters (mL)|The amount of initial intraoperative fill volume in milliliters (mL) in the tissue expander at the time of surgery divided by the manufacturers recommended total tissue expander volume will be measured. Each breast will be measured separately.|Single intra-operative measurement at first surgery|Volume measurements were not captured for all subjects.|||mL||Standard Deviation|Mean
2659075|NCT01591746|Primary|Physical Well-Being Using the BREAST-Q, Reconstruction Module|The Physical Well-Being scale of the BREAST-Q, Reconstruction module, will be used for this purpose. The BREAST-Q is a validated patient-reported outcome measure to accurately assess quality of life and patient satisfaction. The Reconstruction module Physical Well-Being scale has questions on the function and participation in activities before and after breast reconstruction. For this study, subjects were asked to answer 16 questions on how often they experienced each symptom, using score of 1 to 5, where 1 was none of the time and 5 was very often. Answers from these questions were combined to provide a total physical well-being score (for a total possible range of 16-80) for each patient at each visit. Lower scores reflected fewer symptoms and higher satisfaction where higher scores reflected more symptoms and less satisfaction.|first post-operative visit (1-2 weeks post surgery)||||score on a scale||Inter-Quartile Range|Median
2659076|NCT01591746|Primary|Change From Baseline in Average Pain Scores Using a Numeric Pain Intensity Scale|The numeric pain intensity scale (NPIS) will be completed at the preoperative visit and again at the first postoperative visit. The NPIS is a visual analog scale (VAS) commonly used to assess clinical pain. Subjects are asked to rate their pain on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.|preoperative visit, first postoperative visit (1-2 weeks post surgery)||||score on a scale||Inter-Quartile Range|Median
2659077|NCT01591733|Secondary|Utilization of Health Services (Emergency Room, Hospital and Intensive Care Unit)|Summary of the number of hospitalizations, intensive care unit (ICU) stays, emergency department (ED) stays, and palliative care use for the study population.|2 years||2020-01-31|01/2020||||
2659078|NCT01591733|Secondary|Quality of Life, Symptom Burden, and Mood|Patient-reported outcomes: We will use descriptive statistics to describe Quality of Life (QOL) (EORTC QLQ-C30), symptom burden (ESAS-r) and mood (HADS) for the entire study cohort.|2 years||2020-01-31|01/2020||||
2659079|NCT01591733|Secondary|Correlation of Mutational Analysis Biomarkers|To correlate mutational analysis biomarkers (SNaPSHOT assay) with response to treatment|2 years||2020-01-31|01/2020||||
2659080|NCT01591733|Secondary|Local Control Rates|The number of participants that achieved local control. Local control was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors). Local Failure is defined as progression of the primary tumor, or to the reappearance of tumor at the primary site.|From the start of treatment until the end of treatment with FOLFIRINOX, or until disease progression (median duration of follow-up of approximately 14 months)|The first 5 participants treated who only received 4 cycles of FOLFIRINOX instead of 8 were not included in the analysis of local control.|||Participants|||Count of Participants
2659081|NCT01591733|Secondary|Rate of Pathologic Downstaging|To determine the rate of pathologic down-staging among participants that underwent pancreaticoduodenectomy or distal pancreatectomy. The pathologic downstaging rate is the proportion of patients with the primary tumor and nodes downstaged based on final pathology of the surgical specimen.|Baseline, Post surgery||2020-01-31|01/2020||||
2659082|NCT01591733|Secondary|30 Day Post-operative Mortality Rate|The number of participants that died within 30 days after undergoing pancreaticoduodenectomy or distal pancreatectomy.|30 days post surgery (about 6 months from baseline)|The number of participants that underwent surgery|||Participants|||Count of Participants
2659083|NCT01591733|Secondary|The Proportion of Participants With Surgery Related Adverse Events|The number of participants with surgery related any grade adverse events following pancreaticoduodenectomy or distal pancreatectomy after receiving preoperative FOLFIRINOX and preoperative short course radiation therapy. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).|At the time of surgery, 30 days post-surgery|The participants that underwent surgery|||proportion of participants||90% Confidence Interval|Number
2659084|NCT01591733|Secondary|Preoperative Toxicity of Grade 3 or Worse Related to FOLFIRINOX and Chemoradiation|Frequency of grade 3 or greater adverse events deemed related to FOLFIRINOX+short course radiation therapy. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).|From the start of treatment until the end of chemoradiation, about 4 months||||Participants|||Count of Participants
2659085|NCT01591733|Secondary|Median Overall Survival|Median overall survival, as measured from the start of treatment until the time of death.|From the start of treatment until the time of death, median duration of follow-up of 37.7 months||||Months||95% Confidence Interval|Median
2659086|NCT01591733|Secondary|Median Progression-Free Survival|The median progression free survival as measured from the start of treatment until the time of disease progression or death, whichever occurs first. Disease status was evaluated using RECIST (Response Evaluation Criteria in Solid Tumors). Disease progression is defined as having at least a 20% increase in the sum of the longest diameter (LD) of target lesion, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|From the start of treatment until death or disease progression, median duration of follow-up of 14.7 months||||Months||95% Confidence Interval|Median
2659087|NCT01591733|Primary|Rate of R0 Resection|The rate of R0 resection of patients with borderline-resectable adenocarcinoma of the head of the pancreas, along with borderline-resectable and resectable adenocarcinoma of the body and tail of the pancreas. R0 resection means that following surgery, no cancer cells are seen microscopically at the resection margin.|Post-surgery (about 4 months post baseline)||||Participants|||Count of Participants
2659088|NCT01591681|Secondary|Percent of Nights With Sensor Glucose >250 mg/dL||Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use||||percentage of nights|Participants||Number
2659089|NCT01591681|Secondary|Overnight Area Under the Curve 250 mg/dl Per 8 Hour|The measure is reporting area under the curve for glucose concentrations below 250 mg/dL and above 60 mg/dL. Overall time below and above a threshold and area under a curve was divided by total time and multiplied by 8 hours.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use||||mg*hr/dL|Participants|Inter-Quartile Range|Median
2659280|NCT01589926|Secondary|Rate of PCCU Transfers.||Diagnosis until discharge. Average 7 days.|Study was terminated due to low enrollment. Only three participants were enrolled and none initiated treatment.||||||
2659097|NCT01591681|Secondary|Percentage of Sensor Glucose Values 71 to 180 mg/dL|The median percentages of the number of glucose values with values of 71-180 mg/dL overall.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use||||percentage glucose values|Participants|Inter-Quartile Range|Median
2659098|NCT01591681|Primary|Hypoglycemia Outcome: Percentage of Nights With Sensor Glucose Value </=60 mg/dl|Each night is categorized as to whether hypoglycemia occurred. Hypoglycemia is defined as the occurrence of one or more CGM glucose values ≤60 mg/dL. The percentage of hypoglycemic nights will be tabulated separately with versus without the closed-loop control system in use. A repeated measures logistic regression model will be used to compare intervention versus control nights accounting for correlated data from the same subject and adjusting for the baseline (bedtime) sensor glucose.|Overnight from system activation to deactivation in the morning upon awakening for 42 nights of system use||||percentage of nights|Participants||Number
2659099|NCT01591616|Secondary|ECGs (QTcB Interval)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.||||milliseconds||Standard Deviation|Mean
2659100|NCT01591616|Secondary|ECGs (QT Interval)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.||||milliseconds||Standard Deviation|Mean
2659101|NCT01591616|Secondary|ECGs (QRS Duration)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.||||milliseconds||Standard Deviation|Mean
2659102|NCT01591616|Secondary|ECGs (PR Interval)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.||||milliseconds||Standard Deviation|Mean
2659103|NCT01591616|Secondary|ECGs (Ventricular Heart Rate)|Ventricular heart rate, PR interval, QRS duration, QT interval, and QTcB intervals were calculated.|Pre-dose, 1 hour, 2 hour, 4 hour post-dose.||||Beats per minute||Standard Deviation|Mean
2659104|NCT01591616|Secondary|Vital Signs (Diastolic Pressure)||Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose||||mmHg||Standard Deviation|Mean
2659105|NCT01591616|Secondary|Vital Signs (Systolic Pressure)||Pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.||||mmHg||Standard Deviation|Mean
2659106|NCT01591616|Secondary|Vital Signs (Pulse)|Vital signs (pulse, systolic and diastolic pressure) were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.|Pre-dose and every 10 minute to 240 minutes post-dose.||||Beats per minute||Full Range|Mean
2659107|NCT01591616|Primary|Pharmacokinetics|The study focused on the pharmacokinetics of prilocaine and lidocaine, o-toluidine (metabolite of prilocaine) and 2, 6-xylidine (metabolite of lidocaine). We evaluated blood samples of15 subjects at the following time points: pre-dose, at 5,10,15,30, 60, 90, 120 and 240 min post dose. We calculated Cmax (maximum observed plasma concentration) and Tmax (time to maximum plasma concentration).|5, 10, 15, 30, 60, 90, 120, and 240 minutes||||hours||Full Range|Geometric Mean
2659108|NCT01591616|Secondary|Safety|"The % MetHb levels and vital signs (pulse, systolic and diastolic pressure) were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.~ECG taken at pre-dose and 1, 2 and 4h post dose, measurement of heart rate and PR, QRS, QT and QTcB intervals.~Visual analogue scale conducted at pre-dose (immediately before Oraqix administration), immed. post extraction, at 0.25, 0.5, 1 and 2h post dose and prior to discharge just after 4h post dose.~For each subject, phone call was made at +24h as follow up pursuant to the protocol."|blood draws pre-dose, 2 and 4 hours postdose||||Percentage MetHb||Standard Deviation|Mean
2659109|NCT01591616|Primary|Pharmacokinetics|The study focused on the pharmacokinetics of prilocaine and lidocaine, o-toluidine (metabolite of prilocaine) and 2, 6-xylidine (metabolite of lidocaine). We evaluated blood samples of15 subjects at the following time points: pre-dose, at 5,10,15,30, 60, 90, 120 and 240 min post dose. We calculated Cmax (maximum observed plasma concentration) and Tmax (time to maximum plasma concentration).|5, 10, 15, 30, 60, 90, 120, and 240 minutes||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2659110|NCT01591499|Secondary|Lens Preference - Ophthalmologist|"Ophthalmologists preference in terms of lenses rated by questionnaire with a limited selected response. (Choice of Lens? First pair of lenses, Second pair of lenses) (Biofinity, Air Optix, or Purevision)~Measured at completion of V5 (lens pair two evaluation). Both lenses have been worn. Total time since base line is 34-48 days."|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal/Air Optix Aqua Multifocal N=70, 8 missing values; Biofinity Multifocal/Purevision Multifocal N=68, 8 missing values; Evaluated at least one lens N=138, 16 missing values.)|||percentage of investigators|Participants||Number
2659111|NCT01591499|Secondary|Lens Preference - Participant|"The number of participants who preferred a lens pair rated by diary questionnaire with a limited selected response.(Which pair of lenses did you prefer? The first pair, the second pair). Reported per lens.~Measured at completion of V5 (lens pair two evaluation). Both lenses have been worn. Total time since base line is 34-48 days."|Measured at V5|(Participant Flow: Biofinity Multifocal/Air Optix Aqua Multifocal N=70, 8 missing values; Biofinity Multifocal/Purevision Multifocal N=68, 7 missing values; Evaluated at least one lens N=138, 15 missing values.)|||percentage of participants|||Number
2659112|NCT01591499|Secondary|Clinical Performance - Lens Wettability|"The ophthalmologist's rating of lens wettability by questionnaire as a limited selected response (Zero, Low, Acceptable, Good or Excellent). Assessed with the slit lamp and reported per lens.~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 6 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)|||percentage of investigators|||Number
2659124|NCT01591499|Secondary|Visual Performance - Near, Low Contrast Vision|"The number of letters read at a near of 40 centimeters under 10% low contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 4 missing values; Purevision Multifocal N=68, 4 missing values)|||number of letters read||Standard Deviation|Mean
2659113|NCT01591499|Secondary|Geometric Performance - Lens Mobility|"The ophthalmologist's rating of lens movement during blinking by questionnaire as a limited selected response (Optimal, Acceptable with a tendency to be tight, Acceptable with a tendency to be Flat, Unacceptable and too tight, or Unacceptable too flat). Assessed with the slit-lamp and reported per lens.~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 6 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)|||Investigators|||Number
2659114|NCT01591499|Secondary|Geometric Performance - Lens Centration|"Description: The ophthalmologist's rating of lens centration during Focus and Shift When Blinking by questionnaire as a limited selected response (Optimal, Decentration Acceptable or Decentration Unacceptable). Assessed with the slit lamp and reported per lens.~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 12 missing values; Air Optix Aqua Multifocal N=70, 9 missing values; Purevision Multifocal N=68, 6 missing values)|||Investigators|||Number
2659115|NCT01591499|Secondary|Comfort of Use - Average Wearing Time|"The average numbers of hours per day of lens wear by patient. Reported per lens. Calculated by number of hours worn.~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two Patients' subjective rating for lens comfort of use by patient diary and reported per lens. (Average Wearing Time in hours per day)"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 11 missing values; Air Optix Aqua Multifocal N=70, 10 missing values; Purevision Multifocal N=68, 4 missing values)|||hours/day||Standard Deviation|Mean
2659116|NCT01591499|Secondary|Subjective Rating of Lens Comfort - General Comfort|"Patients' subjective rating for lens comfort by patient diary and reported per lens. (General Comfort, Scale 0-100, 0=very uncomfortable, 100=very comfortable).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 4 missing values)|||units on a scale||Standard Deviation|Mean
2659117|NCT01591499|Secondary|Subjective Rating of Lens Comfort - End of Day|"Patients' subjective rating for lens comfort by patient diary and reported per lens. (At End of Day, Scale 0-100, 0=very uncomfortable, 100=very comfortable).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)|||units on a scale||Standard Deviation|Mean
2659118|NCT01591499|Secondary|Subjective Rating of Lens Comfort - During Day|"Patients' subjective rating for lens comfort by patient diary and reported per lens. (During the Day, Scale 0-100, 0=very uncomfortable, 100=very comfortable).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 4 missing values)|||units on a scale||Standard Deviation|Mean
2659119|NCT01591499|Secondary|Subjective Rating of Lens Comfort, Fitting|"Patients' subjective rating for lens comfort by patient diary and reported per lens. (After lens fitting, Scale 0-100, 0=very uncomfortable, 100=very comfortable).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 7 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 5 missing values)|||units on a scale||Standard Deviation|Mean
2659120|NCT01591499|Secondary|Visual Performance - Near Stereoscopic Vision|"The mean number of occurrences where the number of the last figure where the patient equipped with analyzers can make out the raised circle (from number 1 to 9), performed at a distance of 40 centimeters, using Wirt Vectographic Stereopsis Test. Reported per lens.~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 10 missing values; Air Optix Aqua Multifocal N=70, 7 missing values; Purevision Multifocal N=68, 4 missing values)|||number of occurrances||Standard Deviation|Mean
2659121|NCT01591499|Secondary|Visual Performance: Distance, High Contrast Vision|"The number of letters read at a distance of 5 meters under 90% high contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 5 missing values; Air Optix Aqua Multifocal N=70, 5 missing values; Purevision Multifocal N=68, 4 missing values)|||number of letters read||Standard Deviation|Mean
2659122|NCT01591499|Secondary|Visual Performance: Distance, Low Contrast Vision|"The number of letters read at a distance of 5 meters under 10% low contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 4 missing values; Purevision Multifocal N=68, 4 missing values)|||number of letters read||Standard Deviation|Mean
2659123|NCT01591499|Secondary|Visual Performance: Near, High Contrast Vision|"The number of letters read at a near of 40 centimeters under 90% high contrast. Measured by objective assessment and reported per lens. Rated on a visual chart (La Galinet- number of letters read).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 4 missing values; Purevision Multifocal N=68, 4 missing values)|||number of letters read||Standard Deviation|Mean
2659125|NCT01591499|Secondary|Visual Performance - Quality of Distance Vision|"Patients' subjective rating for quality of distance vision by patient diary and reported per lens. (driving, looking at a landscape, etc. 0-100, 0=totally blurred, 100=perfectly clear).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at 17-24 days V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 3 missing values; Purevision Multifocal N=68, 2 missing values)|||units on a scale||Standard Deviation|Mean
2659126|NCT01591499|Secondary|Visual Performance - Quality of Intermediate Vision|"Patients' subjective rating for quality of intermediate vision by patient diary and reported per lens. (distance equivalent to an arm's length. 0-100, 0=totally blurred, 100=perfectly clear).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 3 missing values; Air Optix Aqua Multifocal N=70, 3 missing values; Purevision Multifocal N=68, 3 missing values)|||units on a scale||Standard Deviation|Mean
2659127|NCT01591499|Secondary|Visual Performance - Quality of Near Vision|"Patients' subjective rating for quality of near vision by patient diary and reported per lens. (40cm away: reading a newspaper, looking at your watch etc. 0-100, 0=totally blurred, 100=perfectly clear).~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 3 missing values; Air Optix Aqua Multifocal N=70, 3 missing values; Purevision Multifocal N=68, 2 missing values)|||units on a scale||Standard Deviation|Mean
2659128|NCT01591499|Secondary|Visual Performance - Distance Visual Acuity|"Description: The participant's distance binocular visual acuity (at 5 meters) using the La Galinet method. (Decimal scale, Excellent=between 5 and 20 tenths at 5 metres and between 1 and 20 tenths at 40 cm)~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measure at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 5 missing values; Air Optix Aqua Multifocal N=70, 6 missing values; Purevision Multifocal N=68, 6 missing values)|||decimal units on a scale||Standard Deviation|Mean
2659129|NCT01591499|Primary|Visual Performance - Comparison of Initial Refraction to Multifocal Lenses|"The percentage of participants who obtained binocular distance and near visual acuities (VA) at least as good as their initial refraction assessment. Measured by Initial Refraction. Distance binocular VA (at 5 meters) using the Snellen chart decimal scale and near binocular VA (at 40 cm) using the Parinaud chart (smallest to largest letters, Score P1.5, P2, P4, P5).~Change over time measured at V1 (initial refraction) and at V3 (lens pair one evaluation) and V5 (lens pair two evaluation):~V1 = initial refraction at baseline, V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Change over time measured at V1, V3 and V5|"Percentage of patients who obtained distance and near binocular visual acuities at least as good as their initial refraction visual acuities.~(Participant Flow: Biofinity Multifocal N=138, 14 missing values; Air Optix Aqua Multifocal N=70, 12 missing values; Purevision Multifocal N=68, 13 missing values)"|||percentage of participants|||Number
2659130|NCT01591499|Secondary|Visual Performance - Near Visual Acuity|"Description: The participant's near binocular visual acuity (at 40 cm) using the Parinaud chart (smallest to largest letters, Score P1.5, P2, P4, P5) and reported per lens.~Measured at V3 (lens pair one evaluation) or V5 (lens pair two evaluation):~V3 = after 17-24 days of lens wear pair one, V5 = after 17-24 days of lens wear pair two"|Measured at V3 or V5|(Participant Flow: Biofinity Multifocal N=138, 4 missing values; Air Optix Aqua Multifocal N=70, 8 missing values; Purevision Multifocal N=68, 8 missing values)|||participants|||Number
2659131|NCT01591460|Secondary|Percentage of Participants Using Concomitant Medications During Treatment and Follow-Up|Use of concomitant prescription or nonprescription medications during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant medications was calculated as [number of participants reporting concomitant use divided by the number of participants analyzed] multiplied by 100. Medication classes reported by >10% of participants included analgesics, nonsteroidal anti-inflammatory drugs (NSAIDs), antihistamines, corticosteroids, proton pump inhibitors, vitamins and minerals, and beta-adrenoceptor blocking agents as reported here.|Up to 72 weeks (from Baseline until 24 weeks after EOT)|Safety Population.|||percentage of participants|||Number
2659132|NCT01591460|Secondary|Percentage of Participants With a Concomitant Disease Prior to or During the Study|The prevalence of concomitant disease at any time from Screening through the end of follow-up was documented. The percentage of participants with a concomitant disease was calculated as [number of participants reporting or diagnosed with concomitant disease divided by the number of participants analyzed] multiplied by 100. Diseases documented for ≥5% of participants included hypertension, diabetes mellitus, hypothyroidism, and vitamin D deficiency as reported here.|Up to 76 weeks (from Screening until 24 weeks after EOT)|Safety Population.|||percentage of participants|||Number
2659133|NCT01591460|Secondary|Percentage of Participants Using Concomitant Hematopoietic Stimulants During Treatment and Follow-Up|Use of concomitant hematopoietic stimulants (such as epoetin) during the 48-week treatment period and/or within 24 weeks of follow-up was documented. The percentage of participants using concomitant hematopoietic stimulants was calculated as [number of participants reporting concomitant use divided by the number of participants analyzed] multiplied by 100.|Up to 72 weeks (from Baseline until 24 weeks after EOT)|Safety Population.|||percentage of participants|||Number
2659134|NCT01591460|Secondary|Time to Safety-Related Dose Modification|Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Median time to safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was estimated using Kaplan-Meier and expressed in weeks.|Up to 48 weeks (from Baseline until EOT)|Safety Population.|||weeks||95% Confidence Interval|Median
2659135|NCT01591460|Secondary|Number of Participants With a Safety-Related Dose Modification|Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. The percentage of participants with a safety-related dose modification (eg, modification due to adverse event or laboratory abnormality) of any study drug was calculated as [number of participants with dose modification divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (from Baseline until EOT)|Safety Population.|||participants|||Number
2659136|NCT01591460|Secondary|Percentage of Participants Receiving Target Administrations of PEG-IFN, RBV, and Boceprevir|The frequency of missed treatments was examined using the number of administrations received as a percentage of target administrations for each study drug. The maximum number of possible administrations was considered in terms of once-weekly injections with PEG-IFN and in terms of treatment days with RBV and boceprevir. The percentage of target administrations each participant received was separated into ranges of <60%, 60 to <80%, 80 to <95%, and ≥95% for each study drug. The percentage of participants who received each range of target administrations was calculated as [number of participants in each range divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (from Baseline until EOT)|Safety Population; only participants providing evaluable data were included in the analysis. Arms were not mutually exclusive.|||percentage of participants|||Number
2659137|NCT01591460|Secondary|Percentage of Participants With a Dose Modification of PEG-IFN, RBV, or Boceprevir By Reason|Dose modifications for each study drug included any dose reduction, treatment interruption, or premature withdrawal. Adverse event (AE)-related reasons were documented, as well as reasons related to insufficient efficacy ('Poor efficacy') or other safety-related reasons ('Safety/other'). The percentage of participants with a dose modification documented for each reason was calculated as [number of participants with dose modification divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (from Baseline until EOT)|Safety Population; n = number of participants who received the respective study medication. Arms were not mutually exclusive.|||percentage of participants|||Number
2659138|NCT01591460|Secondary|Duration of Treatment With PEG-IFN, RBV, and Boceprevir|The duration of treatment with each study drug was determined as the time from treatment start until the last dose of PEG-IFN, RBV, or boceprevir. Median duration of treatment was determined using the actual duration of treatment among individual participants and expressed in weeks.|Up to 48 weeks (from Baseline until EOT)|Safety Population: All participants who received at least one dose of study medication and had at least one post-baseline safety assessment; n = number of participants who received the respective study medication. Arms were not mutually exclusive.|||weeks||Full Range|Median
2659139|NCT01591460|Secondary|Percentage of Participants With Treatment Discontinued Based Upon Elevated (Week 12) or Detectable (Week 24) HCV RNA|Treatment was to be discontinued for participants who met prespecified criteria, termed the futility rule, after 12 or 24 weeks of treatment. Participants were discontinued from treatment for one of the following reasons: HCV RNA viral load ≥100 IU/mL (Week 12) or a detectable HCV RNA viral load (Week 24). HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with treatment discontinued for each reason was calculated as [number of participants meeting one of the above criteria divided by the number of participants analyzed] multiplied by 100.|At 12 and 24 weeks|All-Treated Population. Arms were not mutually exclusive.|||percentage of participants|||Number
2659140|NCT01591460|Secondary|Percentage of Participants With Virological Rebound Following On-Treatment Decline in HCV RNA|Virological rebound was defined as an HCV RNA viral load >1000 IU/mL and a ≥1-log increase from nadir following a decline in HCV RNA from Baseline at any time during treatment (ie, on-treatment decline). Participants who ultimately achieved an EOT response were not considered for virological rebound. The percentage of participants with virological rebound was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)|All-Treated Population; only participants with a previous on-treatment decline in HCV RNA were included in the analysis. Arms were not mutually exclusive.|||percentage of participants||95% Confidence Interval|Number
2659141|NCT01591460|Secondary|Percentage of Participants With Virological Breakthrough Following On-Treatment Response|Virological breakthrough was defined as an HCV RNA viral load greater than (>) 1000 IU/mL following a previously undetectable level at any time during treatment (ie, virological response). Participants who ultimately achieved an EOT response were not considered for virological breakthrough. The percentage of participants with virological breakthrough was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100.|Up to 48 weeks (at Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT)|All-Treated Population; only participants with a previous on-treatment virological response were included in the analysis. Arms were not mutually exclusive.|||percentage of participants||95% Confidence Interval|Number
2659142|NCT01591460|Secondary|Percentage of Participants With Virological Relapse Following EOT Response|Virological relapse was defined as a detectable post-treatment HCV RNA viral load following a previously undetectable EOT level (ie, virological response). The percentage of participants with virological relapse was calculated as [number of participants meeting the above criteria divided by the number of participants analyzed] multiplied by 100.|Up to 72 weeks (at 12 and 24 weeks after EOT)|All-Treated Population; only participants with a previous EOT virological response were included in the analysis. Arms were not mutually exclusive.|||percentage of participants||95% Confidence Interval|Number
2659143|NCT01591460|Secondary|Percentage of Participants With at Least a 1-Log, 2-Log, or 3-Log Reduction in HCV RNA|HCV RNA levels were obtained routinely during and after treatment. Reductions in HCV RNA viral load by 1-log, 2-log, or 3-log increments were determined relative to Baseline HCV RNA. Each increment represents a reduction greater than or equal to (≥) the specified log value, including results for which HCV RNA was below the limit of quantification (25 IU/mL). The percentage of participants with each log reduction in HCV RNA was calculated as [number of participants with log reduction divided by the number of participants analyzed] multiplied by 100.|At Weeks 2, 4, 6, 8, 12, 16, 24, and 28|All-Treated Population. Arms were not mutually exclusive.|||percentage of participants||95% Confidence Interval|Number
2659144|NCT01591460|Secondary|Percentage of Participants With Virological Response|HCV RNA levels were obtained routinely during and after treatment. The percentage of participants with undetectable HCV RNA viral load (ie, virological response) was calculated as [number of participants with undetectable HCV RNA at each timepoint divided by the number of participants analyzed] multiplied by 100.|At Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; and EOT (up to 48 weeks)|All-Treated Population. Arms were not mutually exclusive.|||percentage of participants||95% Confidence Interval|Number
2659160|NCT01591317|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Loading Dose||Day 1 predose up to 24 hours post dose|All randomized participants|||nanogram/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2659145|NCT01591460|Secondary|HCV RNA Levels|HCV RNA levels were obtained routinely during and after treatment. Mean HCV RNA levels were calculated by averaging the HCV RNA levels among all participants analyzed at each collection timepoint and expressed in log10 IU/mL.|At Baseline; Weeks 2, 4, 6, 8, 12, 16, 24, 28, and 36; EOT; and 12 and 24 weeks after EOT (up to 72 weeks)|All-Treated Population; number (n) = number of participants who provided evaluable data at the respective visit. Arms were not mutually exclusive.|||log10 IU/mL||Standard Deviation|Mean
2659146|NCT01591460|Secondary|Percentage of Participants With SVR at 24 Weeks After EOT|SVR at 24 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 24 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower LOD of 10 to 15 IU/mL. The percentage of participants with SVR was calculated as [number of participants with undetectable HCV RNA at 24 weeks after EOT divided by the number of participants analyzed] multiplied by 100.|At 24 weeks after EOT (up to 72 weeks)|All-Treated Population. Arms were not mutually exclusive.|||percentage of participants||95% Confidence Interval|Number
2659147|NCT01591460|Primary|Percentage of Participants With Sustained Virological Response (SVR) at 12 Weeks After End of Treatment (EOT)|SVR at 12 weeks after EOT was defined as an undetectable HCV RNA viral load obtained 12 weeks following completion of treatment. HCV RNA viral load was measured using the Roche COBAS TaqMan 2.0 HCV Test, with a lower limit of detection (LOD) of 10 to 15 international units per milliliter (IU/mL). The percentage of participants with SVR was calculated as [number of participants with undetectable HCV RNA at 12 weeks after EOT divided by the number of participants analyzed] multiplied by 100.|At 12 weeks after EOT (up to 60 weeks)|All-Treated Population. Arms were not mutually exclusive.|||percentage of participants||95% Confidence Interval|Number
2659148|NCT01591408|Primary|Improved Symptom Ratings|"Will test whether subjects receiving real EEG biofeedback report decreased anxiety and irritability relative to subjects receiving sham biofeedback. The scale for each rating was a 0-10, with 0 meaning not at all and 10 being extremely anxious/irritable."|4 weeks|Subjects were active duty military with PTSD diagnosis currently in residential treatment facility|||Rating on scale||Standard Deviation|Mean
2659149|NCT01591382|Secondary|Number of Participants With Treatment Related Adverse Events (AEs)|"Participants were asked to complete a Side Effects Checklist to assess for any unwanted side effects (AEs) of drugs that were administered. The determination of whether or not an AE was treatment related was at the discretion of the Investigator."|Participants were followed for the duration of hospital stay, an average of approximately 3 days.|All randomized participants who completed the study and also completed the Side Effects Checklist.|||participants|||Number
2659150|NCT01591382|Secondary|24-Hour Postoperative Opioid Use|Opioid use is defined as the total milligrams of hydromorphone plus other home or oral opioid used per 24 hours, converted to oral morphine equivalents.|For 24 hours following surgery|All randomized participants who completed the study.|||oral morphine mg equivalents||Standard Deviation|Mean
2659151|NCT01591382|Secondary|Least Postoperative Pain Score|"Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for worst, average, and least pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average least postoperative pain score for each treatment arm is reported."|Participants were followed for the duration of hospital stay, an average of approximately 3 days.|All randomized participants who completed the study.|||units on a scale||Standard Deviation|Mean
2659152|NCT01591382|Secondary|Worst Postoperative Pain Score|"Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for worst, average, and least pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average worst postoperative pain score for each treatment arm is reported."|Participants were followed for the duration of hospital stay, an average of approximately 3 days.|All randomized participants who completed the study.|||units on a scale||Standard Deviation|Mean
2659153|NCT01591382|Primary|Average Postoperative Pain Score|"Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for worst, average, and least pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average postoperative pain score for each treatment arm is reported."|Participants were followed for the duration of hospital stay, an average of approximately 3 days.|All randomized participants who completed the study.|||units on a scale||Standard Deviation|Mean
2659154|NCT01591317|Secondary|Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)|PRU device reported VerifyNow percent inhibition is reported by Accumetrics VerifyNow™ P2Y12 (VN-P2Y12) assay, a point-of-care device that measures platelet aggregation with single-use, disposable cartridges|Predose up to 24 hours post dose on Day 12|All randomized participants|||Percent inhibition of PRU||Standard Deviation|Mean
2659155|NCT01591317|Primary|Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose||Day 11 predose to 24 hours post dose|All randomized participants|||hours||Full Range|Median
2659156|NCT01591317|Primary|Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Maintenance Dose||Day 11 predose to 24 hours post dose|All randomized participants|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2659157|NCT01591317|Primary|Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose|AUC from time zero to the last quantifiable plasma concentration (tlast)|Day 11 predose to 24 hours post dose|All randomized participants|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2659158|NCT01591317|Secondary|Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation|ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition|Predose up to 24 hours post dose on Day 12|All randomized participants|||PRU||Standard Deviation|Mean
2659159|NCT01591317|Primary|Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Loading Dose||Day 1 predose up to 24 hours post dose|All randomized participants|||hours||Full Range|Median
2659439|NCT01588496|Secondary|Part A: Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Part A full analysis set|||percent change||Standard Error|Mean
2659161|NCT01591317|Primary|Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Loading Dose|AUC from time zero to the last quantifiable plasma concentration (tlast)|Day 1 predose up to 24 hours post dose|All randomized participants|||nanogram times hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2659162|NCT01591096|Secondary|Pharmacokinetics of tPA|TIPS will determine the pharmacokinetics of tPA and its inhibitor, plasminogen activator inhibitor, including free tPA, PAI-1, and tPA antigen in children receiving IV tPA for acute AIS. In addition, TIPS will measure the 3-month neurological outcome in children treated with IV tPA.|24 hours|Data cannot be reported in the data table as no data was collected||||||
2659163|NCT01591096|Secondary|Pharmacokinetics of tPA|TIPS will determine the pharmacokinetics of tPA and its inhibitor, plasminogen activator inhibitor, including free tPA, PAI-1, and tPA antigen in children receiving IV tPA for acute AIS. In addition, TIPS will measure the 3-month neurological outcome in children treated with IV tPA.|24 hours|Data cannot be reported in the data table as no data was collected||||||
2659164|NCT01591096|Primary|Symptomatic Intracranial Hemorrhage|Any PH 2 OR, Any intracranial hemorrhage which is judged to be the most important cause of neurological deterioration (a minimum of change of 2 or more points on the PedNIHSS from the lowest PedNIHSS). At the time of each PedNIHSS assessment, the site PI or co-PI will review the patient's course with the care team to ensure that all changes in neurologic status, including improvements since the last assessment by the study team, are captured, OR, Any hemorrhage that results in the need for transfusion, need to discontinue study drug, surgical evacuation of hemorrhage, or death.|36 hours|Data cannot be reported in the data table as no data was collected||||||
2659165|NCT01591044|Primary|Change in FEV1|Change from baseline in pre-BD FEV1 (% predicted) at Week 8.|Baseline and Week 8|All efficacy endpoints were analyzed based on the intent to treat population consisting of all randomized patients.|||percentage of change||Standard Deviation|Mean
2659166|NCT01591018|Secondary|Number of Participants With Clinical Manifested Brain Infarction|to demonstrate an effect of sonolysis on the reduction of risk of clinically stroke due to the activation of endogenous fibrinolytic system during cardiac surgery|30 days after intervention|All enrolled participants were analyzed|||participants|||Number
2659167|NCT01591018|Secondary|Cognitive Decline|"To demonstrate an effect of sonolysis on the reduction of cognitive decline after cardiac surgery measured by ACE-R.~Adenbook´s cognitive examination - revised (ACE-R) can aquire value 0 to 100. Higher value represents better cognitive functions."|30 days after intervention|"50 out of 60 participants completed all cognitive tests in cardiac surgery with sonolysis group.~50 out of 60 participants completed all cognitive tests in cardiac surgery without sonolysis group."|||units on a scale||Inter-Quartile Range|Median
2659168|NCT01591018|Primary|Number od Participants With New Brain Infarction in the Monitored MCA Territory Detected Using MRI|to demonstrate a twenty-percent risk reduction of number and volume of brain infarctions and brain infarctions > 0.5 cm3 in the monitored MCA territory in sonolysis group detected using MRI examination 24 hours after cardiac surgery in 5% level of statistical significance|24 hours after intervention||||participants|||Number
2659169|NCT01591005|Other Pre-specified|Number of Participants With Complications|Any complication during carotid endarterectomy and carotid stenting, sonolysis or 30 days after intervention in all subgroups.|24 hours and 30 days after intervention||||participants|||Number
2659170|NCT01591005|Secondary|Number of Participants With Clinical Vascular Event or Death|"The risk of the occurrence of death, any stroke, or myocardial infarction within 30 days (myocardial infarction was defined as a post-interventional cardiac troponin T level increase >2-fold the upper limit of normal in addition to either chest pain or symptoms consistent with ischemia or electrocardiographic evidence of ischemia) after carotid endarterectomy and carotid stenting using periprocedural sonolysis.~Substudy: The risk of the occurrence of death, any stroke, or myocardial infarction within 30 days (myocardial infarction was defined as a post-interventional cardiac troponin T level increase >2-fold the upper limit of normal in addition to either chest pain or symptoms consistent with ischemia or electrocardiographic evidence of ischemia) between carotid endarterectomy and carotid stenting groups."|30 days after intervention||||participants|||Number
2659171|NCT01591005|Secondary|Number of Participatns With New Ipsilateral Brain Infarctions Detected Using MRI in Endarterectomy and Stenting Groups|"The number of patients with the ipsilateral brain infarctions detected using MRI examination 24 hours after intervention between endarterectomy and stenting using periprocedural sonolysis.~Substudy: The number of patients with the ipsilateral brain infarctions detected using MRI examination 24 hours after intervention between carotid endarterectomy and carotid stenting groups."|24 hours after intervention||||participants|||Number
2659172|NCT01591005|Secondary|Number of Participants With Clinical Manifested Brain Infarction|"The risk of stroke or transient ischemic attack (at 24 hours and 30 days) due to the activation of endogenous fibrinolytic system during carotid endarterectomy and carotid stenting using periprocedural sonolysis.~Substudy: The risk of stroke or transient ischemic attack (at 24 hours and 30 days) due to the activation of endogenous fibrinolytic system between carotid endarterectomy and carotid stenting groups."|24 hours and 30 days after intervention||||participants|||Number
2659173|NCT01591005|Secondary|Cognitive Decline|"The changes in cognitive functions after carotid endarterectomy and carotid stenting measured by Mini-Mental State Examination using periprocedural sonolysis.~Substudy: The changes in cognitive functions after intervention measured by Mini-Mental State Examination between carotid endarterectomy and carotid stenting groups.~Range of scores possible for the Mini-Mental State Examination: 0 - 30 points. Higher values in this range are considered to be a better outcome."|24 hours after intervention|only patients with performed Mini Mental State examination|||Scores on a scale||Inter-Quartile Range|Median
2659174|NCT01591005|Secondary|Participants With a New Brain Infarctions Detected Using Magnetic Resonance in Endarterectomy and Stenting Groups|"The number of participants with a new brain infarctions >0.5 cm3 detected using magnetic resonance examination 24 hours after intervention between endarterectomy and stenting using periprocedural sonolysis.~Substudy: The number of participants with a new brain infarctions >0.5 cm3 detected using magnetic resonance examination 24 hours after intervention between carotid endarterectomy and carotid stenting groups."|24 hours after intervention||||participants|||Number
2659281|NCT01589926|Secondary|Determine Parent and Patient Acceptability of BLPAP Administration in the Setting of ACS.||Upon completion of intervention at 48hrs.|Study was terminated due to low enrollment. Only three participants were enrolled and none initiated treatment.||||||
2659175|NCT01591005|Primary|Participants With a New Brain Infarction Detected Using Magnetic Resonance|"The number of participants with a new brain infarctions in sonolysis group detected using magnetic resonance examination 24 hours after carotid endarterectomy or carotid stenting.~Substudy: The number of participants with a new brain infarctions on brain diffusion-weighted magnetic resonance imaging performed 24 hours after intervention in carotid endarterectomy and carotid stenting groups."|24 hours after intervention||||participants|||Number
2659176|NCT01590979|Primary|Incidence of New Onset Atrial Fibrillation Rate in Post-Operative Cardiac Surgery Patients||3 weeks after surgery|Fifty-four patients were randomized with a mean follow-up of 25 months and none were lost to follow-up. The study was terminated due to slow rate of accrual resulting in a sample size of 27 ranolazine and 27 placebo.|||Participants|||Count of Participants
2659177|NCT01590888|Secondary|Change From Baseline in Cognitive Test Battery - TMT Part B|"Trail Making Test Part B was assessed by the number of seconds to complete the test (from 0 to 240 seconds).~The Trails Making Test Part B actual change from baseline at Week 26 was analysed."|Baseline to 26 weeks|Intent to Treat|||seconds||Standard Deviation|Mean
2659178|NCT01590888|Secondary|Change From Baseline in Brain Function (MRI)|Measure of the structural brain volume as assessed by the left caudate volume.|Baseline to 26 weeks|ITT population. MRI was performed at one site only, resulting in a subset of participants available for analysis.|||mm^3||Standard Deviation|Mean
2659179|NCT01590888|Secondary|Change From Baseline in Urine Biomarkers|Biomarkers assessed primarily with 8-hydroxy-2'-deoxyguanosine, normalised to creatinine concentrations, as a change from baseline.|Baseline to 26 weeks|ITT population|||ng/mL||Standard Deviation|Mean
2659180|NCT01590888|Secondary|Change From Baseline in Blood Biomarkers - Selenium|Biomarkers assessed primarily with plasma selenium as a change from baseline.|Baseline to 26 weeks|ITT population|||ug/L||Standard Deviation|Mean
2659181|NCT01590888|Secondary|Change From Baseline in Blood Biomarkers|Biomarkers assessed primarily with soluble huntingtin protein, normalised to lysate protein concentrations, as a change from baseline.|Baseline to 26 weeks|ITT population|||mg/mL||Standard Deviation|Mean
2659182|NCT01590888|Secondary|Change From Baseline in Brain Function (MRI)|Measure of whole brain iron concentrations.|Baseline to 26 weeks|ITT population. MRI was performed at one site only, resulting in a subset of participants available for analysis.|||mm^3||Standard Deviation|Mean
2659183|NCT01590888|Secondary|Change From Baseline in Blood Biomarkers|Biomarkers assessed primarily with mutant huntingtin protein, normalised to lysate protein concentrations, as a change from baseline.|Baseline to 26 weeks|ITT population|||ratio||Standard Deviation|Mean
2659184|NCT01590888|Secondary|Change From Baseline in Investigator Global Assessments by Efficacy Index|Global function was assessed by the Investigator using the clinical global impression (CGI) scale which included assessing the severity of illness and global improvement and calculating the efficacy index for each participant. The efficacy index aims to relate therapeutic effects to reported side effects as assessed by the Investigator (range from 0 [marked improvement and no side effects] to 4 [unchanged or worse] and side effects outweigh therapeutic effects) and is calculated for each participant by dividing the therapeutic effect score by the side effects score. An improvement is reflected by CGI scale Efficacy Index values >1.|Baseline to 26 weeks|Intent to Treat|||ratio||Standard Deviation|Mean
2659185|NCT01590888|Secondary|Change From Baseline in Behaviour|Total Behavioural score from the Unified Huntington Disease Rating Scale. The behavioural assessment measures the frequency and severity of symptoms related to affect, thought content and coping styles. The total behaviour score is the sum of all responses, with scale range of 0 to 8. Higher scores on the behaviour assessments indicate more severe disturbance than lower scores.|Baseline to 26 weeks|Intent to Treat population analysed|||units on a scale||Standard Deviation|Mean
2659186|NCT01590888|Secondary|Change From Baseline in Functional Abilities|"Total Functional Capacity (TFC) assessment was based on an individual's ability to perform common daily tasks. TFC score range was 0 to 13.~Higher scores on the function scales indicate better functioning than lower scores."|Baseline to 26 weeks|Intent to Treat Population analysed|||units on a scale||Standard Deviation|Mean
2659187|NCT01590888|Secondary|Change From Baseline in Motor Function|Total motor score calculated from the Unified Huntington Disease Rating Scale - Motor Function. The motor section of the UHDRS assesses motor features of HD with standardized ratings of oculomotor function, dysarthria, chorea, dystonia, gait, and postural stability. The total motor impairment scores is the sum of all the individual motor ratings, with higher scores indicating more severe motor impairment than lower scores. A maximum score of 60 is possible (range 0-60).|Baseline to 26 weeks|Intent to Treat population analysed, and defined as all participants who received at least one dose of study and underwent at least one post baseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
2659188|NCT01590888|Secondary|Change From Baseline in Cognitive Test Battery - Composite z Scores|Cognition composite z-scores were calculated for each participant. The composite scores were defined as the mean of the individual z-scores for the various cognition assessments. The Main Composite z-score was calculated for Category Fluency Test, Trail Making Test Part B, Map Search, Symbol Digit Modalities Test and Stroop Word Reading Test. The Exploratory Composite z-score was calculated for Category Fluency Test, Trail Making Test Part B, Map Search, Symbol Digit Modalities Test, Stroop Word Reading Test and Speeded Tapping test. The Executive Function Composite z-score was calculated from Category Fluency Test and Trail Making Test Part B. There is no unit of measure for the z score as it is the pure number calculated from the SD from the mean. A higher z score indicates an improvement.|Baseline to 26 weeks|Intent to Treat|||z score||Standard Deviation|Mean
2659189|NCT01590888|Primary|Safety and Tolerability of PBT2 in Patients With HD|As measured by the total number of participants in each dose group who reported at least one adverse events during the study,|Baseline to 26 weeks|Safety population as defined as all participants who received at least one dose of study drug.|||participants|||Number
2659226|NCT01590771|Secondary|Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin|This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.|Baseline and Week 24|Full analysis set (on metformin) consists of all participants on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2659190|NCT01590875|Primary|Pulmonary Vein Reconnection|In treatment group, 30 minutes after all veins confirmed to be isolated with lasso catheter, 12 mg IV adenosine will be given to treatment group subjects, will monitor with lasso catheter for pulmonary vein reconnection for 5 minutes, if no reconnection, a second dose adenosine will be given and will monitor for additional 5 minutes for pulmonary vein reconnection. Criteria for pulmonary vein reconnection will be recurrence of local pulmonary vein electrical recordings noted on lasso catheter located within the vein. Pulmonary vein isolation is defined as disappearance of all local intracardiac electrograms within a pulmonary vein recorded on a 10 electrode circular catheter or lasso catheter positioned within the vein.|Pulmonary vein reconnection will be monitored for 5 minutes post second dose of adenosine, or on average for 15 minutes after initial electrical isolation of the pulmonary vein.||||Participants|||Count of Participants
2659191|NCT01590875|Primary|Pulmonary Vein Reconnection|In treatment group, 30 minutes after all veins confirmed to be isolated with lasso catheter, 12 mg IV adenosine will be given to treatment group subjects, will monitor with lasso catheter for pulmonary vein reconnection for 5 minutes after adenosine administration.|5 minutes post infusion first dose adenosine||||Participants|||Count of Participants
2659192|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)|||mm Hg||Standard Error|Least Squares Mean
2659193|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pDBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population|||mm Hg||Standard Error|Least Squares Mean
2659194|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||mm Hg||Standard Error|Least Squares Mean
2659195|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|pDBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pDBP value by that pDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||mm Hg||Standard Error|Least Squares Mean
2659196|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)|||mm Hg||Standard Error|Least Squares Mean
2659227|NCT01590771|Secondary|Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone|This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.|Baseline and Week 24|Full analysis set (not on metformin) consists of all participants not on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2659282|NCT01589926|Secondary|Rate of Exchange Transfusions.||Diagnosis until discharge. Average 7 days.|Study was terminated due to low enrollment. Only three participants were enrolled and none initiated treatment.||||||
2659197|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pSBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population|||mm Hg||Standard Error|Least Squares Mean
2659198|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||mm Hg||Standard Error|Least Squares Mean
2659199|NCT01590810|Primary|Change From Baseline in TWA0-24hrs pSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|pSBP was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all pSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each pSBP value by that pSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified pSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||mm Hg||Standard Error|Least Squares Mean
2659200|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)|||mm Hg||Standard Error|Least Squares Mean
2659201|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cDBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population|||mm Hg||Standard Error|Least Squares Mean
2659202|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||mm Hg||Standard Error|Least Squares Mean
2659228|NCT01590771|Secondary|Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and a Sulfonylurea in Combination With Metformin|This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.|Baseline and Week 24|Full analysis set (on metformin) consists of all participants on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2659317|NCT01589497|Secondary|AUC0-24hour for Ethambutol (EMB)|PK AUCs of Ethambutol (EMB) from 0 to 24 hours obtained at Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Ethambutol dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis.|||h*ng/mL||Inter-Quartile Range|Median
2659203|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cDBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|cDBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cDBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cDBP value by that cDBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cDBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||mm Hg||Standard Error|Least Squares Mean
2659204|NCT01590810|Primary|Change From Baseline in TWA0-12hrs HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)|||beats per minute||Standard Error|Least Squares Mean
2659205|NCT01590810|Primary|Change From Baseline in TWA0-12hrs HR in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose|Per-Protocol population|||beats per minute||Standard Error|Least Squares Mean
2659206|NCT01590810|Primary|Change From Baseline in TWA0-12hrs HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||beats per minute||Standard Error|Least Squares Mean
2659207|NCT01590810|Primary|Change From Baseline in Time-weighted Average Across 12 Hours (TWA0-12hrs) HR in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|HR was measured with a validated automatic measuring device. Time-weighted average was obtained as follows: For all HR values obtained over the 12-hour observation period, multiply the length of time that the participant spent at each HR value by that HR value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified HR value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||beats per minute||Standard Error|Least Squares Mean
2659208|NCT01590810|Primary|Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)|||percentage of central pulse pressure||Standard Error|Least Squares Mean
2659229|NCT01590771|Secondary|Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone|A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.|Baseline and Week 24|Full analysis set (not on metformin) consists of all participants not on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.|||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
2659209|NCT01590810|Primary|Change From Baseline in TWA0-24hrs AIx in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population|||percentage of central pulse pressure||Standard Error|Least Squares Mean
2659210|NCT01590810|Primary|Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||percentage of central pulse pressure||Standard Error|Least Squares Mean
2659211|NCT01590810|Primary|Change From Baseline in TWA0-24hrs AIx in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|AIx was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Augmentation index is the percentage of the central pulse pressure attributed to the reflected pulse wave, and is an indirect measure of systemic arterial stiffness. Time-weighted average was obtained as follows: For all AIx values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each AIx value by that AIx value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified AIx value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement. AIx was adjusted for HR.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose; except Period 1: Pre-dose and 2, 4, 12 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||percentage of central pulse pressure||Standard Error|Least Squares Mean
2659212|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel D)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. The same 2 participants received placebo throughout all treatment periods of Panel D. Data for all administrations of placebo in these participants are included (i.e., for placebo, analysis includes 8 observations from 2 participants)|||mm Hg||Standard Error|Least Squares Mean
2659213|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cSBP in Male Participants With Mild to Moderate Hypertension Administered Single Doses of MK-8150 and Placebo (Panel C)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population|||mm Hg||Standard Error|Least Squares Mean
2659214|NCT01590810|Primary|Change From Baseline in TWA0-24hrs cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel B)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of initial administration of MK-8150 120 mg dose and again received placebo during the period of repeat administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||mm Hg||Standard Error|Least Squares Mean
2659215|NCT01590810|Primary|Change From Baseline in Time-weighted Average Across 24 Hours (TWA0-24hrs) cSBP in Healthy Male Participants Administered Single Doses of MK-8150 and Placebo (Panel A)|cSBP was measured by applanation tonometry of the radial artery, using the SphygmoCor System. The central pressure waveform was determined from the peripheral pressure waveform by a transfer function. Time-weighted average was obtained as follows: For all cSBP values obtained over the 24-hour observation period, multiply the length of time that the participant spent at each cSBP value by that cSBP value, add these products together, and then divide by duration of the observation period. The length of time spent at an identified cSBP value was defined as the time elapsed since previous post-dose measurement, or time elapsed since drug administration, if there is no previous post-dose measurement.|Pre-dose and 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose|Per-Protocol population. 2 participants received placebo in period of fasted administration of MK-8150 24 mg dose and again received placebo during the period of fed administration of that dose. Data for both administrations of placebo in these participants are included (i.e., for placebo, analysis includes 10 observations from 8 participants)|||mm Hg||Standard Error|Least Squares Mean
2659216|NCT01590810|Primary|Number of Participants Who Discontinued Study Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.|Up to 14 days after the last dose (Up to approximately 42 days)|All participants who received a dose of study drug|||participants|||Number
2659217|NCT01590810|Primary|Number of Participants With an Adverse Event (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.|Up to 14 days after the last dose (Up to approximately 42 days)|All participants who received a dose of study drug|||participants|||Number
2659218|NCT01590797|Primary|Number of Participants Discontinuing Study Medication Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 24|The APaT population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.|||Participants|||Number
2659219|NCT01590797|Primary|Number of Participants With One or More Adverse Events|An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to Week 26|The All Patients as Treated (APaT) population consisted of all randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the study treatment they actually received for the analysis of safety data.|||Participants|||Number
2659220|NCT01590797|Secondary|Change From Baseline in 2-Hour Post Meal Glucose Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin||Baseline and Week 24|The FAS consisted of all randomized participants receiving insulin alone or in combination with metformin, took at least one dose of study treatment, had at least one observation for the analysis endpoint subsequent to the first dose of study treatment, and had baseline data for the analysis endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
2659221|NCT01590797|Secondary|Change From Baseline in HbA1C Levels at Week 24 in Participants Receiving Insulin in Combination With Metformin||Baseline and Week 24|The FAS consisted of all randomized participants receiving insulin in combination with metformin, took at least one dose of study treatment, had at least one observation for the analysis endpoint subsequent to the first dose of study treatment, and had baseline data for the analysis endpoint.|||A1C %||95% Confidence Interval|Least Squares Mean
2659222|NCT01590797|Primary|Change From Baseline in Hemoglobin A1C (HbA1C) Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin||Baseline and Week 24|The Full Analysis Set (FAS) consisted of all randomized participants receiving insulin alone or in combination with metformin, took at least one dose of study treatment, had at least one observation for the analysis endpoint subsequent to the first dose of study treatment, and had baseline data for the analysis endpoint.|||A1C %||95% Confidence Interval|Least Squares Mean
2659223|NCT01590771|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 24 weeks|All participants as treated population defined as all randomized participants who received at least one dose of study medication. Participants are included in the treatment group corresponding to the study treatment actually received.|||Participants|||Number
2659224|NCT01590771|Primary|Number of Participants Who Experienced an Adverse Event|An adverse event is any untoward medical occurrence in a participant administered study drug which does not necessarily have a causal relationship with the treatment. Adverse events may include the onset of new illness and the exacerbation of pre-existing conditions.|Up to 26 weeks|All participants as treated population defined as all randomized participants who received at least one dose of study medication. Participants are included in the treatment group corresponding to the study treatment actually received.|||Participants|||Number
2659225|NCT01590771|Secondary|Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone|This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.|Baseline and Week 24|Full analysis set (not on metformin) consists of all participants not on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2659230|NCT01590771|Secondary|Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin|A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.|Baseline and Week 24|Full analysis set (on metformin) consists of all participants on metformin who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.|||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
2659231|NCT01590771|Secondary|Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin|This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0.|Baseline and Week 24|Full analysis set consists of all participants who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2659232|NCT01590771|Secondary|Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin|This change from baseline reflects the 2-hr PMG level at Week 24 minus the 2-hr PMG level at Week 0.|Baseline and Week 24|Full analysis set consists of all participants who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.|||mg/dL||95% Confidence Interval|Least Squares Mean
2659233|NCT01590771|Primary|Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin|A1C was measured as a percent. This change from baseline reflects the A1C percent at Week 24 minus the A1C percent at Week 0.|Baseline and Week 24|Full analysis set consists of all participants who received at least one dose of study drug, have a baseline measurement, and have at least one post-randomization measurement.|||Percent of glycosylated hemoglobin (A1C)||95% Confidence Interval|Least Squares Mean
2659234|NCT01590758|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAE)|The numbers of participants with TEAEs, including those with Serious TEAEs, are reported|28 days|Safety|||Participants|||Count of Participants
2659235|NCT01590758|Secondary|Number of Participants With Microbiological Success|The numbers of participants with Microbiological Response, defined as eradication of all initial pathogens, are reported.|28 days|Intent-To-Treat Microbiological (positive for baseline pathogens)|||Participants|||Count of Participants
2659236|NCT01590758|Primary|Number of Participants With Clinical Response|The numbers of participants with Clinical Response, defined as resolution of infection, are reported.|28 days|Intent-To-Treat|||Participants|||Count of Participants
2659237|NCT01590563|Secondary|Occurrence of Malposition, Expulsion.|Expulsion and malposition are established risks involved with IUD use. Occurrence of these risks may drastically reduce effectiveness. It is expected that the IUB(tm) form will reduce these risks.|12 months||||Number of cases|||Number
2659238|NCT01590563|Primary|Efficacy in Preventing Pregnancy|Prevention of pregnancy will be measured. Pregnancy rates are expected to be comparable to current IUDs.|12 months||||Number of pregnancies|||Number
2659239|NCT01590563|Primary|Rates of Uterine Perforation|Uterine perforation is an established risk of IUD deployment which may cause certain health hazards. It is anticipated that the IUB(tm), through its form and deployment pattern, will reduce this risk.|During installation||||Number of cases|||Number
2659240|NCT01590550|Secondary|Heparin Use Rate|The heparin use rate will be assessed as the percentage of hemodialysis treatments that required additional use of heparin to maintain circuit patency. This will be assessed from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued based on clinical indications, upto a maximum period of 6 months|Patients will be followed until inpatient hemodialysis sessions with Citrasate® are discontinued||||percentage of hemodialysis treatments|||Number
2659241|NCT01590550|Secondary|Saline Flush Rate|Saline flush rate will be assesed as the percentage of hemodialysis treatments that require one or more saline flushes to maintain circuit patency from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued based on clinical indications, upto a maximum period of 6 months|Patients will be followed until HD Citrate dialysate is discontinued, average 3 weeks||||percentage of hemodialysis treatments|||Number
2659242|NCT01590550|Primary|Dialyzer Clotting Rate|Dialyzer clotting rate will be assessed as the percent of hemodialysis treatments that developed a clot in the dialyzer from the time that the patient is enrolled in the study until the time hemodialysis treatments with Citrasate® are discontinued.|Followed until HD with Citrate dialysate is discontinued, average 3 weeks|18 patients and 119 HD treatments|||percentage of total treatments|||Number
2659243|NCT01590433|Secondary|Metabolic Characteristics That Predict Robust Response to Exenatide Treatment|"The secondary objective of this study is:~- To identify metabolic characteristics that predict robust response to exenatide treatment"|6 years||2020-01-31|01/2020||||
2659244|NCT01590433|Primary|Change in Body Weight|Change in body weight after 12 weeks of treatment with exenatide or placebo twice daily injections. This outcome compares baseline and 12 week body weight.|12 weeks|subjects randomized to exenatide or placebo|||percentage weight loss||Standard Deviation|Mean
2659245|NCT01590433|Primary|Mechanisms and Patterns of Weight Loss With Exenatide Treatment|"The primary objectives of this study is:~- To investigate mechanisms and patterns of weight loss with exenatide treatment, especially among individuals who have robust early weight loss (greater than 5% weight loss in 12 weeks) with exenatide"|6 years||2020-01-31|01/2020||||
2659246|NCT01590394|Primary|Large Plastic Biliary Stents Will Have a Longer Patency Time Than Conventionally Used 10 Fr Stents in Subjects as Compared to Well-known Published Historical Control Data.||6 months|Data were not analyzed, because there were too few subjects to make the outcome measure meaningful. Principal investigator retired before any analysis could be performed.||||||
2659247|NCT01590264|Secondary|Change in Tinnitus Handicap Inventory|Participant will complete the Tinnitus Handicap Inventory (THI)at the end of 2 weeks of treatment. Difference of the THI post treatmement minus baseline THI was calculated. Scale ranges in scores from 0 to 100 with 0 = no bother and 100 being the most bothered.|Baseline, 2 weeks|Pilot study convenience sample|||units on a scale||Full Range|Median
2659248|NCT01590264|Primary|Adverse Events|Subject will be queried for Adverse Events daily for 2 weeks of treatment. This is foremost a feasibility study, so measure of Adverse Events and relation to treatment is primary outcome.|Daily for 2 weeks.|Pilot study based on convenience sample.|||participants|||Number
2659249|NCT01590238|Primary|Hair Density Change After Three Treatments|Hair density index at calibrated distance from glabella in a 2 cm x 2 cm midline square at 6 month follow up visit as a percentage of initial (pre-treatment) hair density index, measured using a proprietary hair densitometer.|6 months after initial visit||||percentage of pre-treatment hair density||Standard Deviation|Mean
2659250|NCT01590212|Primary|Depression Measured on EPDS|"Depression scores as measured on the EPDS post-birth (approximately 8-12 weeks postnatal)~Edinburgh Postnatal Depression Scale (EPDS): is a standardised questionnaire which generates a single score. Normal score=0-9, Borderline=10-12, Probable depression=13-30."|Post-birth (8-12 weeks postnatal)||||scores on a scale||Full Range|Mean
2659251|NCT01590212|Primary|Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale|"Anxiety, depression and irritability measured on the Adult Wellbeing Scale post-birth (approximately 8-12 weeks postnatal)~The Adult Wellbeing scale (AWS): a validated questionnaire which generates scores in four domains - depression, anxiety, outward-directed irritability and inward-directed irritability. The sub-scales have different cut-off scores that indicate a possible problem in that area: Anxiety (normal=0-5, borderline=6-8, problem 9-15), Depression (normal=0-3, borderline=4-6, problem 7-15), Outward directed irritability (normal=0-4, borderline=5-7, problem 8-12), Inward directed irritability (normal=0-3, borderline=4-6, problem 7-12),"|Post-birth (8-12 weeks postnatal)||||scores on a scale||Full Range|Mean
2659252|NCT01590212|Primary|Depression Measured on EPDS|"Depression as measured on the EPDS at 9-12 weeks after baseline~Edinburgh Postnatal Depression Scale (EPDS): is a standardised questionnaire which generates a single score. Normal score=0-9, Borderline=10-12, Probable depression=13-30."|Post-intervention (approximately 9 -12 weeks after baseline)||||scores on a scale||Full Range|Mean
2659253|NCT01590212|Primary|Anxiety, Depression and Irritability Measured on Adult Wellbeing Scale|"Anxiety, depression and irritability measured on Adult Wellbeing Scale at 9-12 weeks after baseline.~The Adult Wellbeing scale (AWS): a validated questionnaire which generates scores in four domains - depression, anxiety, outward-directed irritability and inward-directed irritability. The sub-scales have different cut-off scores that indicate a possible problem in that area: Anxiety (normal=0-5, borderline=6-8, problem 9-15), Depression (normal=0-3, borderline=4-6, problem 7-15), Outward directed irritability (normal=0-4, borderline=5-7, problem 8-12), Inward directed irritability (normal=0-3, borderline=4-6, problem 7-12),"|Post intervention (approximately 9-12 weeks after baseline)||||Scores on a scale||Full Range|Mean
2659254|NCT01590017|Primary|Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria (CTC) Version 4.0 Will be Tabulated|Number of patients who experienced one or more adverse events|12 months||||Participants|||Count of Participants
2659255|NCT01590017|Primary|Treatment Completion Rate Using the Binomial Proportion and Its 95% Confidence Interval|Number of participants who completed therapy|8 weeks||||Participants|||Count of Participants
2659256|NCT01589978|Secondary|ARC ST Rate in PLATINUM-like Population.|Using the Academic Research Consortium (ARC) definition, the (definite/probable) stent thrombosis (ST) rate in the PLATINUM-like* population will be analyzed. Statistical testing will be used to determine if the annual increase after the first year in ST rates observed in PLATINUM-like patients meets the performance goal of 1.0% (expected rate of 0.4% + a delta of 0.6%).|Annually through 5 years|Note: PLATINUM-like population for the Primary Endpoint at 12 months includes PROMUS Element patients from the PLATINUM trials (WH and SV) (N=862), PLATINUM-like patients from PE-Prove (N=269), and PLATINUM-like patients from PROMUS Element Plus US Post-Approval Study (N=776) (as stated as a subgroup in the Participant Flow Module.|||percentage of participants|||Number
2659257|NCT01589978|Secondary|Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients|Any revascularization of the target vessel, myocardial infarction related to the target vessel, or death related to the target vessel. See individual components for descriptions. Statistical testing will determine if the rate meets the performance goal (12.6%)|12 Months||||percentage of patients|||Number
2659258|NCT01589978|Secondary|All Death or Myocardial Infarction Rate|See description of individual events.|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
2659259|NCT01589978|Secondary|Non-cardiac Death Rate|"Non-cardiac death is defined as death not due to cardiac causes.~Cardiac death is death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded."|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
2659260|NCT01589978|Secondary|All Death Rate|All death includes cardiac death and non-cardiac death.|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
2659261|NCT01589978|Secondary|Rate of Target Vessel Failure (TVF) Related to the PROMUS Element Stent|"Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel.~For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF."|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
2659262|NCT01589978|Secondary|Target Vessel Failure (TVF) Rate|"Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel.~For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF."|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
2659263|NCT01589978|Secondary|Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent|See individual descriptions of events.|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
2659264|NCT01589978|Secondary|Cardiac Death or Myocardial Infarction (MI) Rate|See individual descriptions of events.|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
2659265|NCT01589978|Secondary|Rate of Target Vessel Revascularization (TVR) Events Related to the PROMUS Element Stent|Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
2659267|NCT01589978|Secondary|Rate of Cardiac Death Events Related to the PROMUS Element Stent|Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
2659268|NCT01589978|Secondary|Cardiac Death Rate|Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
2659269|NCT01589978|Secondary|Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
2659270|NCT01589978|Secondary|Myocardial Infarction (MI) Rate|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
2659271|NCT01589978|Secondary|Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent|Composite of cardiac death, myocardial infarction, and target vessel revascularization related to the PROMUS Element stent|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
2659272|NCT01589978|Secondary|Major Adverse Cardiac Event Rate (MACE)|Composite of cardiac death, myocardial infarction, and target vessel revascularization|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
2659273|NCT01589978|Secondary|Rate of Longitudinal Stent Deformation|Compression/elongation of a stent along its long axis resulting from interaction with an ancillary device (e.g., guide catheter) which catches the stent end or an internal stent strut; can occur with advancement or withdrawal of ancillary device. Under fluoroscopy, longitudinal compression usually results in increased strut density and elongation in decreased strut density ('pseudo-fracture'); both can occur in the same stent.|Index Procedure||||stents|||Number
2659274|NCT01589978|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|≤24 hours, 30 days, 180 days, annually through 5 years||||percentage of patients|||Number
2659275|NCT01589978|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients|ARC definite/probable ST rate in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if the annual ST rate increase after the first year meets the performance goal (1.0%)|12 months|PROMUS Element PLATINUM-Like patients (a subgroup of the overall population as described in the Participant Flow Module), N=776.|||percentage of patients|||Number
2659276|NCT01589978|Primary|Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients|Cardiac death or myocardial infarction rate at 12 months post implantation in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if rate meets the performance goal (3.2%)|12 months|Note: PLATINUM-like population for the Primary Endpoint at 12 months includes PROMUS Element patients from the PLATINUM trials (WH and SV) (N=862), PLATINUM-like patients from PE-Prove (N=269), and PLATINUM-like patients from PROMUS Element Plus US Post-Approval Study (N=776) (as stated as a subgroup in the Participant Flow Module.|||percentage of patients|||Number
2659277|NCT01589926|Secondary|Difference in Mean SpO2 Recording During Sleep.|Peripheral capillary oxygen saturation (SpO2) is an estimate of the amount of oxygen in the blood. It is the percentage of haemoglobin containing oxygen compared to the total amount of haemoglobin in the blood (i.e. oxygenated haemoglobin vs oxygenated and non-oxygenated haemoglobin).|48hrs after initiation of treatment|Study was terminated due to low enrollment. Only three participants were enrolled and none initiated treatment.||||||
2659278|NCT01589926|Secondary|Difference in Pulmonary Function Tests.||48hrs after initiation of treatment|Study was terminated due to low enrollment. Only three participants were enrolled and none initiated treatment.||||||
2659283|NCT01589926|Primary|Length of Stay as Measured by the Time From Initial Diagnosis of ACS Until Meeting Discharge Criteria.|Length of stay as measured by the time from initial diagnosis of ACS until meeting discharge criteria. It is anticipated length of stay will correlate to efficacy of treatment: shorter stay is theorized to indicate more efficient treatment.|From diagnosis of ACS until meeting discharge criteria- Average 7 days.|Study was terminated due to low enrollment. Only three participants were enrolled and none initiated treatment.||||||
2659284|NCT01589822|Secondary|Incidence of Stricture||up to Day 90||||participants|||Number
2659285|NCT01589822|Secondary|Incidence of GI Leak||90 days|The primary endpoint was absence of leak (success) within 40 days. Any data missing was considered failures. 3 EVICEL and 2 SoC subjects had missing data. These subjects were considered failures for the primary endpoint. The secondary endpoint was incidence of leak within 90 days post operatively. Missing data was not assumed to be leaks.|||participants|||Number
2659286|NCT01589822|Secondary|Incidence of Adverse Events||up to Day 90||||number of adverse events|||Number
2659287|NCT01589822|Primary|Absence of Gastrointestinal (GI) Leak||40 days||||participants|||Number
2659288|NCT01589770|Secondary|Left Atrium Size, mm|left atrium size, measured in millimeters|one scan, cross sectional comparison||||mm||Inter-Quartile Range|Median
2659289|NCT01589770|Primary|Left Ventricular Mass Indexed to BSA, g/m^2|Left Ventricular Mass (LVM) is known to increase in proportion to overall body size and differs by gender. To assess an individual's risk for a cardiovascular event based on LVM,an adjustment for the patient's body size should be done. LVM in grams was divided by body surface area in meters squared, to adjust for body size. Body surface area was calculated by square root (height (cm) X weight (kg)/3600).|one scan, cross sectional comparison||||g/m^2||Inter-Quartile Range|Median
2659290|NCT01589653|Secondary|Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden|Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores. The score measured treatment satisfaction which included a subscale score -treatment burden. The scores were transformed to a 0−100 scale with higher scores indicating a better health state.|Week 0, week 20|Full analysis set (FAS) included all randomised subjects.|||scores on a scale||Standard Deviation|Mean
2659291|NCT01589653|Secondary|Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)|Mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) scores. The score measured treatment satisfaction which included an overall score as well the subscale scores (daily life, diabetes management, compliance and psychological health). The scores were transformed to a 0−100 scale with higher scores indicating a better health state.|Week 0, week 20|Full analysis set (FAS) included all randomised subjects.|||scores on a scale||Standard Deviation|Mean
2659292|NCT01589653|Secondary|Number of Hypoglycaemic Episodes During the Trial From Baseline|The number of hypoglycaemic episodes (a blood glucose level of approximately 2.8 mmol/L [50 mg/dL] or plasma glucose level 3.1 mmol/L [56 mg/dL]) during the trial.|Week 20|Full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF). 154 subjects contributed to the analysis.|||episodes|||Number
2659293|NCT01589653|Secondary|Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline|Change in FPG (laboratory values) from baseline to the end of the treatment period|Week 0, week 20|Full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF). A total of 150 subjects contributed to the analysis.|||mg/dL||Standard Deviation|Mean
2659294|NCT01589653|Primary|Change in HbA1c From Baseline|Change in HbA1c (%) from baseline to the end of the treatment period.|Week 0, week 20|Full analysis set (FAS) included all randomised subjects.|||percentage change in HbA1c||Standard Error|Least Squares Mean
2659295|NCT01589601|Secondary|Utilization and Cost Measured by Hospital Readmissions|We evaluated the total burden of all-cause, cardiovascular and Heart Failure-specific readmissions with the palliative care intervention compared to usual care.|Baseline (2 weeks post hospital discharge), 6 months||||Number of readmissions|||Number
2659296|NCT01589601|Secondary|Utilization and Cost Measured by the Aggregate Cost of Care|"The investigators will use administrative data from Duke Health System to estimate costs of care to determine the cost effectiveness of palliative care versus normal care. At all follow-up points in the study (2 weeks, 6 weeks, 3 months, 6 months, and every 6 months thereafter), patients will be asked if they received care outside of the Duke Health System and to estimate the number of physician visits and/or days in the hospital. The cost of such care will be estimated using the Medical Expenditure Panel Survey and included in the aggregate cost of care from randomization until completion of the study.~Due to administrative delays, constraints and time to access the cost data, the study team is still working through the data aggregation for full utilization comparison as well as cost comparison."|time of randomization until end of follow-up, approximately 3.5 years|Data not collected.||||||
2659297|NCT01589601|Secondary|Change in FACIT-Sp|Spiritual well-being will be assessed using the Functional Assessment of Chronic Illness Therapy Spiritual Well-Being Scale (FACIT-Sp) at 2 weeks, 3 months, and 6 months. The FACIT-Sp is a 12 item scale which assesses the role of faith in illness and meaning, peace, and purpose in life. The range of FACIT-Sp 12 score is 0-48, with higher values representing an increased spirituality across the range of religious traditions.|Baseline (2 weeks post hospital discharge), 3 months, 6 months|Participants that completed the baseline, 3 month, and 6 month FACIT-Sp.|||units on a scale||Standard Deviation|Mean
2659298|NCT01589601|Secondary|After-Death Bereaved Family Member Interview - Hospice Version|A structured interview with the caregiver of those subjects that die during the study will be conducted 6 weeks following the study subject's death using the After-Death Bereaved Family Member Interview - Hospice Version. The interview provides an assessment of patient-focused, family-centered care and assesses overall quality of care received. An overall rating is derived from the ratings questions. The scoring is calculated using a pre-formatted Microsoft Excel spreadsheet for data entry and analysis. For scoring, the 5 rating questions were summed and the final scale varied between 0 (indicating worst possible care) to 50 (best possible care).|6 weeks after patient's death|Overall rating scale 6 weeks after patient's death.|||units on a scale||Standard Deviation|Mean
2659440|NCT01588496|Secondary|Part A: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Part A full analysis set|||percent change||Standard Error|Mean
2659299|NCT01589601|Secondary|Change in Hospital Anxiety and Depression Scale (HADS) - Depression and Anxiety|"Depression and anxiety will be assessed in all patients using the self-administered Hospital Anxiety and Depression Scale (HADS) at 2 weeks, 3 months, and 6 months.~Range of HADS total score is 0-42. It is divided into depression and anxiety. Each is 0-21. A score of 11 or higher indicates the possible presence of the mood disorder (clinical caseness) with a score of 8 to 10 being suggestive of the presence of the respective state. The two subscales, anxiety and depression, have been found to be independent measures. In its current form the HADS in this study is divided into 3 ranges: normal (0-7), borderline (8-10), abnormal (11-21). Movement between categories would constitute a clinically significant change in the health status."|Baseline (2 weeks post hospital discharge), 3 months, 6 months|Participants that completed the baseline, 3 month, and 6 month HADS.|||units on a scale||Standard Deviation|Mean
2659300|NCT01589601|Primary|Change in Functional Assessment of Chronic Illness Therapy - Palliative Care Scale (FACIT-Pal)|"The primary endpoint is health-related quality of life as measured by the FACIT-Pal.~The FACIT-Pal is a 46-item measure of self-reported quality of life (27 general quality of life; 19 palliative care) that assesses quality of life in several domains. The range of FACIT-Pal total score is 0-184, a higher score is better."|Baseline, 6 months|Participants who completed the baseline and 6 month FACIT-Pal.|||units on a scale||Standard Deviation|Mean
2659301|NCT01589601|Primary|Change in Kansas City Cardiomyopathy Questionnaire (KCCQ)|"The primary endpoint is health-related quality of life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).~The KCCQ is a 23-item, disease-specific questionnaire scored from 0-100 with high scores representing better health status."|Baseline, 6 months|Participants that completed the baseline and 6 month KCCQ|||units on a scale||Standard Deviation|Mean
2659302|NCT01589510|Primary|IOP at Week 14|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 14.|Week 14|All patients with data for this outcome measure|||Millimeters of Mercury||Standard Deviation|Mean
2659303|NCT01589510|Secondary|Physician Assessment of Patient Compliance Compared to Previous Therapy|Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.|Week 14|All patients with data for this outcome measure|||Patients|||Number
2659304|NCT01589510|Secondary|Percentage of Patients Who Continue Lumigan® 0.01% Treatment|Patients who will continue Lumigan® 0.01% after 14 weeks of treatment was assessed as Yes or No.|Week 14|All patients|||Percentage of Patients|||Number
2659305|NCT01589510|Secondary|Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment|Patients who discontinued Lumigan® 0.01% prior to 14 weeks was assessed as Yes or No.|14 Weeks|All patients|||Percentage of Patients|||Number
2659306|NCT01589510|Secondary|Physician Assessment of Tolerability on a 4-Point Scale|Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|Week 14|All patients with data for this outcome measure|||Patients|||Number
2659307|NCT01589510|Secondary|Patient Assessment of Tolerability on a 4-Point Scale|Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.|Week 14|All patients with data for this outcome measure|||Patients|||Number
2659308|NCT01589510|Secondary|Physician Evaluation of IOP Lowering in the Study Eye(s)|IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.|Week 14|All patients with data for this outcome measure|||Eyes|Participants||Number
2659309|NCT01589510|Primary|Intraocular Pressure (IOP) at Baseline|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.|Baseline|All patients with data for this outcome measure|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2659310|NCT01589497|Secondary|Moxifloxacin PK Parameter CLast at Day 14|Moxifloxacin PK parameter CLast obtained Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Moxifloxacin dosing at Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis. Only the participants in the RHZE-RMZE arm received Mox from Day 3 through Day 14.|||ng/mL||Inter-Quartile Range|Median
2659311|NCT01589497|Secondary|Moxifloxacin PK Parameter Cmax at Day 14|Moxifloxacin PK parameter Cmax obtained Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Moxifloxacin dosing at Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis. Only the participants in the RHZE-RMZE arm received Mox from Day 3 through Day 14|||ng/mL||Inter-Quartile Range|Median
2659312|NCT01589497|Secondary|Moxifloxacin PK Parameter CL/F at Day 14|Moxifloxacin PK parameter CL/F obtained Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Moxifloxacin dosing at Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis. Only the participants in the RHZE-RMZE arm received Mox from Day 3 through Day 14|||L/hour||Inter-Quartile Range|Median
2659313|NCT01589497|Secondary|AUC0-24hour for Moxifloxacin (Mox) at Day 14|PK AUCs of Moxiflozacin (Mox) from 0 to 24 hours obtained at Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Moxifloxacin dosing at Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis. Only the participants in the RHZE-RMZE arm received Mox from Day 3 through Day 14|||h*ng/mL||Inter-Quartile Range|Median
2659314|NCT01589497|Secondary|Ethambutol PK Parameter CLast|Ethambutol PK parameter CLast obtained Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Ethambutol dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis.|||ng/mL||Inter-Quartile Range|Median
2659315|NCT01589497|Secondary|Ethambutol PK Parameter Cmax|Ethambutol PK parameter Cmax obtained Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Ethambutol dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis.|||ng/mL||Inter-Quartile Range|Median
2659316|NCT01589497|Secondary|Ethambutol PK Parameter CL/F|Ethambutol PK parameter CL/F obtained Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Ethambutol dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis.|||L/hour||Inter-Quartile Range|Median
2659318|NCT01589497|Secondary|Pyrazinamide PK Parameter CLast|Pyrazinamide PK parameter CLast obtained Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Pyrazinamide dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis.|||ng/mL||Inter-Quartile Range|Median
2659319|NCT01589497|Secondary|Pyrazinamide PK Parameter Cmax|Pyrazinamide PK parameter Cmax obtained Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Pyrazinamide dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis.|||ng/mL||Inter-Quartile Range|Median
2659320|NCT01589497|Secondary|Pyrazinamide PK Parameter CL/F|Pyrazinamide PK parameter CL/F obtained Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Pyrazinamide dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis.|||L/hour||Inter-Quartile Range|Median
2659321|NCT01589497|Secondary|AUC0-24hour for Pyrazinamide (PZA)|PK AUCs of Pyrazinamide (PZA) from 0 to 24 hours obtained at Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Pyrazinamide dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis.|||h*ng/mL||Inter-Quartile Range|Median
2659322|NCT01589497|Secondary|Isoniazid PK Parameter CLast at Day 14|Isoniazid (INH) PK parameter CLast obtained Day 14. The lower limit of quantification of the assay (LLOQ) for INH was 100 ng/mL. The results below the lower limit of quantification were assigned as one-half the value of the LLOQ, which was 50 ng/mL.|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RHZE-RZE and RHZE-RMZE arms did not receive INH from Day 3 through Day 14 and the participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.|||ng/mL||Inter-Quartile Range|Median
2659323|NCT01589497|Secondary|Isoniazid PK Parameter Cmax at Day 14|Isoniazid PK parameter Cmax obtained Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RHZE-RZE and RHZE-RMZE arms did not receive INH from Day 3 through Day 14 and the participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.|||ng/mL||Inter-Quartile Range|Median
2659324|NCT01589497|Secondary|Isoniazid PK Parameter CL/F at Day 14|Isoniazid PK parameter CL/F obtained Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RHZE-RZE and RHZE-RMZE arms did not receive INH from Day 3 through Day 14 and the participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.|||L/hour||Inter-Quartile Range|Median
2659325|NCT01589497|Secondary|AUC0-24hour for Isoniazid at Day 14|PK AUCs of Isoniazid from 0 to 24 hours obtained at Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RHZE-RZE and RHZE-RMZE arms did not receive INH from Day 3 through Day 14 and the participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.|||h*ng/mL||Inter-Quartile Range|Median
2659326|NCT01589497|Secondary|Isoniazid PK Parameter CLast at Day 1|Isoniazid (INH) PK parameter CLast obtained Day 1. The lower limit of quantification of the assay (LLOQ) for INH was 100 ng/mL. The results below the lower limit of quantification were assigned as one-half the value of the LLOQ, which was 50 ng/mL.|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 1|63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.|||ng/mL||Inter-Quartile Range|Median
2659327|NCT01589497|Secondary|Isoniazid PK Parameter Cmax at Day 1|Isoniazid PK parameter Cmax obtained Day 1|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 1|63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.|||ng/mL||Inter-Quartile Range|Median
2659328|NCT01589497|Secondary|Isoniazid PK Parameter CL/F at Day 1|Isoniazid PK parameter CL/F obtained Day 1|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 1|63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.|||L/hour||Inter-Quartile Range|Median
2659329|NCT01589497|Secondary|AUC0-24hour for Isoniazid (INH) at Day 1|PK AUCs of Isoniazid (INH) from 0 to 24 hours obtained at Day 1|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Isoniazid dosing at Day 1|63 with qualified samples were included in the primary and secondary analyses including PK analysis. The participants in the RZE-RZE arm did not receive INH from Day 1 through Day 14.|||h*ng/mL||Inter-Quartile Range|Median
2659330|NCT01589497|Secondary|Rifampicin PK Parameter Last Concentration (CLast)|Rifampicin (RIF) PK parameter Last Concentration (CLast) obtained Day 1 and Day 14. The lower limit of quantification of the assay (LLOQ) for RIF was 40 ng/mL. The results below the lower limit of quantification were assigned as one-half the value of the LLOQ, which was 20 ng/mL.|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Rifampicin dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis|||ng/mL||Inter-Quartile Range|Median
2659331|NCT01589497|Secondary|Rifampicin PK Parameter Maximum Plasma Concentration (Cmax)|Rifampicin PK parameter Parameter Maximum Plasma Concentration (Cmax) obtained Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Rifampicin dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis|||ng/mL||Inter-Quartile Range|Median
2659332|NCT01589497|Secondary|Rifampicin PK Parameter Clearance (CL/F)|Rifampicin PK parameter Clearance (CL/F) obtained Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Rifampicin dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis|||L/hour||Inter-Quartile Range|Median
2659441|NCT01588496|Secondary|Part A: Change From Baseline in LDL-C at Week 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Week 12|Part A full analysis set|||mg/dL||Standard Error|Mean
2659333|NCT01589497|Secondary|Pharmacokinetic Parameter (PK) Area Under the Concentration-time Curve (AUC0-24hour) for Rifampicin (RIF)|Pharmacokinetic Parameter Area Under the Concentration-time Curve (AUCs) of Rifampicin from 0 to 24 hours obtained at Day 1 and Day 14|-0.5 hour (pre-dose), 1, 2, 3, 5, 7, 10, 12 and 24 hours after Rifampicin dosing at Day 1 and Day 14|63 with qualified samples were included in the primary and secondary analyses including PK analysis|||h*ng/mL||Inter-Quartile Range|Median
2659334|NCT01589497|Secondary|Correlation Between Time to Positivity (TTP) and log10 Transformed Colony-forming Unit (CFU) Counts Per mL|Pearson correlation coefficient was used to examine the correlation between TTP and log10 CFU among all qualified samples obtained on study|Pre-entry, Day 0, Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11 and Day 14|Participants with qualified sputum samples who had results available at least one time point specified in the time-frame|||correlation coefficient|||Number
2659335|NCT01589497|Secondary|Log10 Transformed Colony-forming Unit (CFU) Count Per mL From Sputum Samples at Baseline and Day 14|The log10 CFU count per mL from sputum samples processed by standard method or decontaminated method.|Pre-entry, Day 0 and Day 14|Participants with qualified sputum samples who had results available at least one time point specified in the time-frame|||log10 CFU/ mL||Inter-Quartile Range|Median
2659336|NCT01589497|Secondary|Daily Change in Time to Positivity (TTP) From Day 2 to Day 14|"The daily change in TTP was calculated as follows:~EBA2-14(TTP) = (TTP at day 2 - TTP at day 14)/12."|Day 2 and Day 14|Participants with qualified sputum samples who had results available at all time points specified in the time-frame|||hours||Inter-Quartile Range|Median
2659337|NCT01589497|Secondary|Daily Change in Time to Positivity (TTP) From Baseline (Study Treatment Initiation) to Day 2|"The daily change in TTP was calculated as follows:~EBA0-2(TTP) = (baseline TTP (mean of TTP at pre-entry and day 0) - TTP at day 2)/2."|Pre-entry, Day 0 and Day 2|Participants with qualified sputum samples who had results available at all time points specified in the time-frame|||hours||Inter-Quartile Range|Median
2659338|NCT01589497|Secondary|Daily Change in log10 Colony-forming Unit (CFU) Counts Per mL Sputum From Day 2 to Day 14|"The daily change in log10 CFU/mL sputum was calculated as follows:~EBA2-14(CFU) = (log10 CFU/mL at day 2 - log10 CFU/mL at day 14)/12.~For a CFU/mL count of 0, the log10 CFU/mL was set to 0."|Day 2 and day 14|Participants with qualified sputum samples who had results available at all time points specified in the time-frame|||log10 CFU/ mL||Inter-Quartile Range|Median
2659339|NCT01589497|Secondary|Daily Change in log10 Transformed Colony-forming Unit (CFU) Counts Per mL Sputum From Baseline (Study Treatment Initiation) to Day 2|"The daily change in log10 CFU/mL sputum was calculated as follows:~EBA0-2(CFU) = (baseline log10 CFU/mL sputum (mean of log10 CFU/mL at pre-entry and day 0) - log10 CFU/mL at day 2)/2.~For a CFU/mL count of 0, the log10 CFU/mL was set to 0."|Pre-entry, Day 0 and Day 2|Participants with qualified sputum samples who had results available at all time points specified in the time-frame|||log10 CFU/ mL||Inter-Quartile Range|Median
2659340|NCT01589497|Secondary|Daily Change in Time to Positivity (TTP) From Baseline (Study Treatment Initiation) to Day 14|"The daily change in TTP was calculated as follows:~EBA0-14(TTP) = [baseline TTP (mean of TTP at pre-entry and day 0) - TTP at day 14]/14."|Pre-entry, Day 0 and Day 14|Participants with qualified sputum samples who had results available at all time points specified in the time-frame|||hours||Inter-Quartile Range|Median
2659341|NCT01589497|Primary|Daily Decrease in log10 Transformed Colony-forming Unit (CFU) Counts Per ml Sputum From Baseline (Study Treatment Initiation) to Day 14|"The daily decrease was calculated as follows:~EBA0-14(CFU)= [baseline log10 CFU/mL sputum (mean of log10 CFU/mL at pre-entry and day 0) - log10 CFU/mL at day 14]/14. For a CFU/ml count of 0, the log10 CFU/mL was set to 0.~No formal statistical testing was conducted to compare the arms. Please refer to the explanation in the Protocol Section."|Pre-entry, Day 0 and Day 14|Participants with qualified sputum samples who had results available at all time points specified in the time-frame|||log10 CFU/ mL||Inter-Quartile Range|Median
2659342|NCT01589484|Secondary|SWL Complications|Secondary endpoint will be SWL complications (i.e. pain, hematuria, urinary tract infection, Steinstrasse)|12 weeks after SWL||||participants|||Number
2659343|NCT01589484|Primary|Stone Clearance|After 12 weeks, all patients will be submitted to a new NCCT scan to evaluate stone fragmentation and stone clearance.|12 weeks after SWL|Fragmentation|||participants|||Number
2659344|NCT01589445|Primary|Comparison of Changes in Fasting Serum Insulin (FSI)With Pioglitazone and Metformin|Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.|||μU/ml||Standard Deviation|Mean
2659345|NCT01589445|Primary|Comparison of Changes in HOMA Percent B and HOMA Percent S With Pioglitazone and Metformin|"Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.~Analysis 1: Homeostatic Model Assessment of Beta cell function(HOMA percent B) Analysis 2: Homeostatic Model Assessment of Insulin Sensitivity (Homa percent S)"|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.|||percentage||Standard Deviation|Mean
2659346|NCT01589445|Primary|Comparison of Changes in Insulin Levels (HOMA IR,QUICKI) With Pioglitazone and Metformin|"Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.~Analysis 1: Homeostasis Model Assessment Insulin Resistance(HOMA IR) Analysis 2: Quantitative Insulin sensitivity Check Index(QUICKI)"|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.|||Score on a scale ( SI unit)||Standard Deviation|Mean
2659759|NCT01586364|Primary|Change From Baseline in Hemoglobin Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.|||g/dL||Standard Deviation|Mean
2659347|NCT01589445|Primary|Comparison of Changes in Glycosylated Hemoglobin (HbA1c)With Pioglitazone and Metformin|Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.|||percentage||Standard Deviation|Mean
2659348|NCT01589445|Primary|Comparison of Changes in Fasting Serum Glucose (FSG)With Pioglitazone and Metformin|Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.|||mmol/l||Standard Deviation|Mean
2659349|NCT01589445|Secondary|Comparison of Changes in Lipid Profiles With Pioglitazone and Metformin|"Response rate was defined by ≥10% decrease of FSG or/and ≥1% decrease of HbA1c from the baseline values after 3 months treatment.48 responded to pioglitazone and 32 responded to metformin.~Analysis 1:Total Cholesterol(TC) Analysis 2:Triglyceride(TG) Analysis 3:High Density Lipoprotein(HDL) Analysis 4:Low Density Lipoprotein(LDL)"|3 months for each drug|After completion of both of the treatments, it is found in the 3rd month some patients didn't response according to the response rate and during result analysis the responded numbers (48 and 32)were considered only. That's why the number of participant in both the trials didn't match with number of participants analyzed.|||mg/dl||Standard Deviation|Mean
2659350|NCT01589315|Primary|Remission Based on HDRS, Hamilton Depression Rating Scale, 24 Item.|"The number of treatment sessions is not fixed and could extend up to 12 provided that patients show continued improvement and tolerate the treatment. With 3 FEAST sessions per week, the course may take up to 12 weeks to be completed.~The Hamilton Rating Scale for Depression is a widely used clinician administered rating.Scores range from (Min) 0 to (Max) 52. Higher score means worse depression. The definition of remission was a Ham Depression Score (24 item) of < or equal to 10."|up to 4 weeks||||Participants|||Count of Participants
2659351|NCT01589302|Secondary|Physical Health Quality of Life as Measured by a 12 Item Short-Form Health Survey|Physical Health Quality of life measures were administered during screening and on Days 1 (±3), of Cycle 1, Day 1 (±3), of Cycle 2 and on day 1 (±7) of Cycles 3, 6, and then every 3 months thru Cycle 24 and at time of progression and /or end of treatment. SF-12 assesses aspects of quality of life including physical functioning, role functioning-physical, bodily pain, general health perceptions, vitality, social functioning, role functioning-emotional, and mental health. Subscale raw scores are transformed to put each subscale on a 0-100 range with higher scores indicative of greater functioning. Subscale scores are standardized based on US General Population norms and aggregated based on factor score coefficients into two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Component scores are norm-based t-scores meaning scores above 50 indicate better functioning than average functioning while scores below 50 indicate worse functioning.|up to 5 months|Data was reported for month 5 from start of treatment|||units on a scale||Standard Deviation|Mean
2659352|NCT01589302|Secondary|Sleep Through Quality of Life as Measured by a Medical Outcomes Study-Sleep Scale|Sleep problems quality of life measures is a six-item sleep problems index I of the Medical Outcomes Study-Sleep Scale used to assess sleep problems. Participants reported how often they experience six specific difficulties with sleep on a 6-point Likert scale (1=All of the time to 6=None of the time). Scores transformed into a 0-100 scale with higher scores indicating greater sleep problems.|at 5 months|Data was reported for month 5 from start of treatment|||units on a scale||Standard Deviation|Mean
2659353|NCT01589302|Secondary|Fatigue Symptom Inventory (FSI) Interference Quality of Life as Measured by a 11-item Total Disruption Index Sub Scale of Fatigue Symptoms Inventory|The Fatigue Interference quality of life measures is a 11-item self reported questionnaire used to measure frequency, severity and daily pattern of fatigue Symptoms as well as impact of QOL in the past week. The Total Disruption Index (TDI) an 7 item subset of FSI was used. Items were rated on a 11-point Likert scale from 0=no interference to 10=extreme interference. Total scores could range from 0 to 70, with higher scores indicating greater fatigue interference.|at 5 months|Data was reported for month 5 from the start of treatment|||units on a scale||Standard Deviation|Mean
2659354|NCT01589302|Secondary|Mental Health Quality of Life Was Measured by the Mental Component Summary Score of the Medical Outcomes Study|SF-12 assesses aspects of quality of life including physical functioning, role functioning-physical, bodily pain, general health perceptions, vitality, social functioning, role functioning-emotional, and mental health. Subscale raw scores are transformed to put each subscale on a 0-100 range with higher scores indicative of greater functioning. Subscale scores are standardized based on US General Population norms and aggregated based on factor score coefficients into two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Component scores are norm-based t-scores meaning scores above 50 indicate better functioning than average functioning while scores below 50 indicate worse functioning.|at 5 months||||units on a scale||Standard Deviation|Mean
2659355|NCT01589302|Secondary|Negative Mood Quality of Life Measured by a 37-item Questionnaire|The Profile of Mood States-Short Form (POMS-SF) yields six subscales, Tension, Depression, Anger, Vigor, Fatigue, and Confusion. A total mood disturbance score is found by summing the six subscales. Total Mood Disturbance (TMD) scores range from -24 to 124 with higher scores indicating greater mood disturbance.|at 5 months|Data was reported for month 5 from start of treatment|||units on a scale||Standard Deviation|Mean
2659356|NCT01589302|Secondary|Cognitive-Affective Depressive Symptoms as Measured by the Beck Depression Inventory-2nd Edition (BDI-II)|The Beck Depression Inventory-2nd edition is a 21-item measure of depressive symptoms. Scores were calculated representing the cognitive-affective and the somatic symptoms associated with depression (e.g. sadness, pessimism, loss of pleasure) during past month on scale from 0 to 3. Items were summed, with higher scores indicating more depressive symptoms. The scores on the scale from range from 0 to 42.|at 5 months|Data was reported for month 5 from start of treatment|||units on a scale||Standard Deviation|Mean
2659357|NCT01589302|Secondary|Cancer-Specific Stress as Measured by the Impact of Event Scale-Revised (IES-R)|Cancer-Specific Stress was measured by the Impact of Event Scale-Revised Participants rated the intensity of these feelings using a five-point Likert scale ranging from 0=not at all to 4=extremely. Patients rated the frequency of their feelings or events for the previous week before treatment. The items were summed for a total score that ranged from 0 to 64|Up to 2 years|Data was reported for start of treatment only|||units on a scale||Standard Deviation|Mean
2659358|NCT01589302|Secondary|Effectiveness of Ibrutinib Bridging Patients to Allogeneic Stem Cell Transplant and Outcome of Patients Following This Intervention|The number of participants with successful Allogenic Stem Cell Transplant|Up to 2 years||||participants|||Number
2659359|NCT01589302|Secondary|Decrease in Immune Suppression of CLL Cells||up to 3 months|Data was not collect and analyzed for this outcome measure||||||
2659360|NCT01589302|Secondary|Resistance Studies of Ibrutinib|Percentage of patients with BTK C481S mutation or PLCG2 mutation|Up to 4 years||||percentage of patients||95% Confidence Interval|Number
2659361|NCT01589302|Secondary|Number of Patients With Adverse Events, Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Adverse events grade 3 or higher using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 with the attribution of either definite, possible or probable related.|Up to 2 years post treatment||||patients|||Number
2659362|NCT01589302|Secondary|2-year Kaplan-Meier Estimate of OS for Relapsed and Refractory CLL Patients Treated With Single Agent PCI-32765|Time from date of first treatment with ibrutinib until the date of progression or death from any cause. Those alive and progression free are censored at the date of last clinical assessment.|2 years|There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients|||percent of patients||95% Confidence Interval|Number
2659363|NCT01589302|Secondary|Percentage of Patients With Overall Survival (OS)|Time from date of first treatment with ibrutinib until the date of death from any cause or the date of last contact for those alive.|2 years|There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients|||percent of patients||95% Confidence Interval|Number
2659364|NCT01589302|Secondary|Number of Patients With 6 Month ORR of Single Agent Ibrutinib in Relapsed and Refractory CLL Patients|The 6 month overall response rates overall response rate (ORR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 6 months|There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients|||patients||95% Confidence Interval|Number
2659365|NCT01589302|Secondary|Best Overall Response Rate Using the Revised International Workshop on Chronic Lymphocytic Leukemia (IWCLL) Working Group Guidelines|Responders were subjects who achieved a complete response (CR), partial response (PR) or PR with persistent lymphocytosis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 2 years|There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients|||percentage of patients||95% Confidence Interval|Number
2659366|NCT01589302|Primary|Determine the 2 Year Progression-free Survival (PFS) of Single Agent PCI-32765 in Patients With Relapsed and Refractory CLL.|We will summarize our findings for this endpoint independently as well within each cohort (del17p vs other cytogenetic groups). We will evaluate the proportion of patients who are progression-free and alive at two years or have gone on to transplant (treatment successes) over the total number of evaluable patients; eligible patients who received at least one dose of therapy are considered evaluable. Assuming that the number of treatment successes as defined above is binomially distributed, we will also include 95% binomial confidence intervals for the estimates corresponding to each cohort.|up to 2 years|There are 2 different cohorts Del (17p) and Non-Del (17p) each with 76 patients|||percentage of patients||95% Confidence Interval|Number
2659367|NCT01589237|Secondary|Changes From Baseline in Apolipoprotein B-100 Levels up to 52 Weeks|Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein B-100. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.|||percentage change||Geometric Coefficient of Variation|Geometric Mean
2659368|NCT01589237|Secondary|Changes From Baseline in Apolipoprotein B-48 Levels up to 52 Weeks|Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein B-48. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.|||percentage change||Geometric Coefficient of Variation|Geometric Mean
2659377|NCT01589185|Secondary|Efficacy: All-Cause Mortality (Day 7)|A summary of the number (%) of patients who died on or before timepoints Day 7 visit (mITT population) is provided, by treatment group (overall) and placebo.|Patients who died during the specified timepoints (Day 7)|The modified intent to treat (mITT) population corresponded to the safety (ITT) population minus one patient for which infection by S. aureus was not confirmed.|||Participants|||Count of Participants
2659369|NCT01589237|Secondary|Changes From Baseline in Apolipoprotein A1 Levels up to 52 Weeks|Fasting blood samples were collected by direct venipuncture or an indwelling cannula to evaluate the drug effect on lipoprotein biomarkers such as Apolipoprotein A1. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.|||percentage change||Geometric Coefficient of Variation|Geometric Mean
2659370|NCT01589237|Secondary|Changes From Baseline in Free Fatty Acid Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including free fatty acid level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.|||percentage change||Geometric Coefficient of Variation|Geometric Mean
2659371|NCT01589237|Secondary|Changes From Baseline in Glycerol Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including glycerol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.|||percentage change||Geometric Coefficient of Variation|Geometric Mean
2659372|NCT01589237|Secondary|Changes From Baseline in HDL and Non HDL Cholesterol Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including HDL and non HDL cholesterol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.|||percentage change||Geometric Coefficient of Variation|Geometric Mean
2659373|NCT01589237|Secondary|Changes From Baseline in Cholesterol Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including cholesterol level. Lipid measurements were collected after a 12 hour (overnight) fast. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.|||percentage change||Geometric Coefficient of Variation|Geometric Mean
2659374|NCT01589237|Secondary|Changes From Baseline in Triglyceride Levels up to 52 Weeks|Blood samples were collected for a fasting lipid panel, including total triglycerides. Lipid measurements were collected after a 12 hour (overnight) fast. The maintenance of effect was assessed on triglyceride levels during continued therapy with LCQ908 for up to 52 weeks. For patients from LCQ908 arm of study CLCQ908A2212, baseline was the assessment obtained at Week 0 of current study. For patients from study CLCQ908B2302, baseline is defined as the average of values taken Day -3 and Week 0 (randomization) in study CLCQ908B2302. The geometric mean for the percentage (%) change is calculated from back-transforming the mean of the log transformed ratio to baseline values: (exp(mean of the log-transformed ratio to baseline values) -1)*100.|Baseline, Week 12, 24 and 52|Full analysis set (FAS) – All subjects in the extension study who were in FAS in either study LCQ908A2212 or LCQ908B2302. At each time point post-baseline, only patients with a value at both baseline and the post-dose time point are included.|||percentage change||Geometric Coefficient of Variation|Geometric Mean
2659375|NCT01589237|Primary|Number of Patients With Any Adverse Events, Serious Adverse Events and Death||52 weeks|Safety set (SAF) - All subjects who received at least one dose of study drug and had at least one post-baseline safety assessment in this extension study.|||Participants|||Number
2659376|NCT01589185|Secondary|Efficacy: All-Cause Mortality (Day 21)|A summary of the number (%) of patients who died on or before timepoints Day 21 visit (mITT population) is provided, by treatment group (overall) and placebo.|Patients who died during the specified timepoints (Day 21)|The modified intent to treat (mITT) population corresponded to the safety (ITT) population minus one patient for which infection by S. aureus was not confirmed.|||Participants|||Count of Participants
2659442|NCT01588496|Primary|Part A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Week 12|Part A full analysis set (all enrolled participants who received at least 1 dose of evolocumab)|||percent change||Standard Error|Mean
2659378|NCT01589185|Secondary|Efficacy: All-Cause Mortality (Day 14)|A summary of the number (%) of patients who died on or before timepoints Day 14 visit (mITT population) is provided, by treatment group (overall) and placebo.|Patients who died during the specified timepoints (Day 14)|The modified intent to treat (mITT) population corresponded to the safety (ITT) population minus one patient for which infection by S. aureus was not confirmed.|||Participants|||Count of Participants
2659379|NCT01589185|Secondary|Efficacy: All-Cause Mortality (End Of Study [EOS])|A summary of the number (%) of patients who died on or before timepoints Day EOS (mITT population) is provided, by treatment group (overall) and placebo.|Patients who died during the specified timepoints (by EOS), up to day 107|The modified intent to treat (mITT) population corresponded to the safety (ITT) population minus one patient for which infection by S. aureus was not confirmed.|||Participants|||Count of Participants
2659380|NCT01589185|Primary|Efficacy Endpoint: All-Cause Mortality by Day 28|A summary of the number (%) of patients who died on or before Day 28 (mITT population) is provided, by treatment group and overall.|At Day 28 post infusion (Day 0)|The modified intent to treat (mITT) population corresponded to the safety (ITT) population minus one patient for which infection by S. aureus was not confirmed.|||Participants|||Count of Participants
2659381|NCT01589094|Secondary|2 Year Recurrence Free Survival (RFS) Rate for Nonresponders|Defined as the time from treatment initiation to disease progression, local-regional or metastatic recurrence, or death analyzed using the Kaplan Meier method.|2 years|20 out of 46 total participants were responders.|||percentage of participants|||Number
2659382|NCT01589094|Secondary|2 Year Recurrence Free Survival (RFS) Rate for Responders|Defined as the time from treatment initiation to disease progression, local-regional or metastatic recurrence, or death analyzed using the Kaplan Meier method.|2 years|26 out of 46 total participants were responders.|||percentage of participants|||Number
2659383|NCT01589094|Secondary|Number of Participants With Toxicity|Toxicity will be graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events version 4.0.|1 year||||Participants|||Count of Participants
2659384|NCT01589094|Primary|Pathologic Response Rate|Defined as the absence of muscle invasive carcinoma (<pT2 disease) and the absence of lymph node metastases (N0) on the final cystectomy specimen. Pathologists will assess surgical specimens systematically using criteria agreed upon for all conventional neoadjuvant treatment based on the AJCC TNM staging system.|1 year|5 participants who completed 3 or more cycles of treatment did not undergo radical cystectomy: 1 refused surgery, 1 developed metastatic progression after 4 cycles, 1 withdrew consent, 1 was lost to follow-up, and 1 patient was incidentally diagnosed with moyamoya and discontinued the study because of the risk for vascular thrombotic events|||percentage of participants||95% Confidence Interval|Number
2659385|NCT01588990|Secondary|FACT-C Score: Phase B|FACT-C is one part of the FACIT Measurement System, which comprehensively assesses the health-related QoL of cancer participants and participants with other chronic illnesses. It is composed of 27 items of the general version of the FACT-C as a general core QoL measure and has a disease-specific subscale containing 9 colorectal cancer-specific items. It consists of total 36 items, summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range from 0 to 28, emotional well-being (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL.|Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]|"Phase B FAS population. Number Analyzed = participants who were evaluable at the specified time point for this outcome."|||units on a scale||Standard Deviation|Mean
2659386|NCT01588990|Secondary|Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Score: Phase A|FACT-C is one part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System, which comprehensively assesses the health-related QoL of cancer participants and participants with other chronic illnesses. It is composed of 27 items of the general version of the FACT-C as a general core QoL measure and has a disease-specific subscale containing 9 colorectal cancer-specific items. It consists of total 36 items, summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range from 0 to 28, emotional well-being (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL.|Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]|"FAS population. Number Analyzed = participants who were evaluable at the specified time point for this outcome."|||units on a scale||Standard Deviation|Mean
2659387|NCT01588990|Secondary|AQoL-8D Global Utility Score: Phase B|AQoL-8D provides a global utility score and consists of 8 separately scored dimensions including Independent Living, Life Satisfaction, Mental Health, Coping, Relationships, Self Worth, Pain, and Senses. Each of the 8 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 [worst] to 1 [best]) and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health).|Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]|"Phase B FAS population. Number Analyzed = participants who were evaluable at the specified time point for this outcome."|||units on a scale||Standard Deviation|Mean
2659394|NCT01588990|Secondary|Association Between NLR (NLR ≤5 Versus NLR >5) and OS as Assessed by Hazard Ratio|NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. OS was defined as the time from the start of initial treatment to the date of death, regardless of the cause of death. The association between NLR (NLR ≤ 5 vs > 5) and OS was reported as hazard ratio.|Baseline up to disease progression, death or end of study (up to 4 years)|FAS population. “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||hazard ratio||95% Confidence Interval|Number
2668022|NCT01509677|Secondary|Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (MMP Type 9 (ng/mL))||Baseline to 14 weeks||||ng/mL||Standard Error|Least Squares Mean
2659388|NCT01588990|Secondary|Assessment of Quality of Life - Eight Dimensions (AQoL-8D) Global Utility Score: Phase A|AQoL-8D provides a global utility score and comprised of 35 questions from which 8 dimensions (Independent Living, Life Satisfaction, Mental Health, Coping, Relationships, Self Worth, Pain, and Senses) are derived. Each of the 8 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 [worst] to 1 [best]) and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health).|Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]|"FAS population. Number Analyzed = participants who were evaluable at the specified time point for this outcome."|||units on a scale||Standard Deviation|Mean
2659389|NCT01588990|Secondary|EuroQol-5D Utility Score: Phase B|"EQ-5D is a standardized generic preference based health related quality of life instrument. It records how one's health is today and consists of a descriptive system. The descriptive system is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension on the EQ-5D involves a 3-point response scale which indicates the level of impairment (level 1 = no problem; level 2 = some or moderate problem[s] and level 3 = unable, or extreme problems). Level of problem reported in each EQ-5D dimension determines a unique health state which is converted into a weighted health state index by applying scores from EQ-5D preference weights elicited from general population samples. This generates a unique description of the subjects' health status, which is valued between 0 (representing death) and 1 (representing perfect health). Higher the score, the better the quality of life."|Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]|"Phase B FAS population. Number Analyzed = participants who were evaluable at the specified time point for this outcome."|||units on a scale||Standard Deviation|Mean
2659390|NCT01588990|Secondary|European Quality of Life 5-Dimension (EuroQol-5D) Utility Score: Phase A|"EQ-5D is a standardized generic preference based health related quality of life instrument. It records how one's health is today and consists of a descriptive system. The descriptive system is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension on the EQ-5D involves a 3-point response scale which indicates the level of impairment (level 1 = no problem; level 2 = some or moderate problem[s] and level 3 = unable, or extreme problems). Level of problem reported in each EQ-5D dimension determines a unique health state which is converted into a weighted health state index by applying scores from EQ-5D preference weights elicited from general population samples. This generates a unique description of the subjects' health status, which is valued between 0 (representing death) and 1 (representing perfect health). Higher the score, the better the quality of life."|Baseline, every 8-9 weeks thereafter, end of treatment (EOT) (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]|"FAS population. Number Analyzed = participants who were evaluable at the specified time point for this outcome."|||units on a scale||Standard Deviation|Mean
2659391|NCT01588990|Secondary|Association Between Longitudinal NLR (Longitudinal NLR ≤5 Versus NLR >5) and OS as Assessed by Hazard Ratio|NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. Longitudinal NLR was assessed by treating the NLR measurements taken over the time-course of treatment as a time-dependent covariate. OS was defined as the time from the start of initial treatment to the date of death, regardless of the cause of death. The association between longitudinal NLR (longitudinal NLR ≤5 vs NLR >5) and OS was reported as hazard ratio.|Baseline up to death or end of study (up to 4 years)|FAS population. “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||hazard ratio||95% Confidence Interval|Number
2659392|NCT01588990|Secondary|Association Between Longitudinal NLR (Longitudinal NLR ≤5 Versus NLR >5) and PFS as Assessed by Hazard Ratio|NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. Longitudinal NLR was assessed by treating the NLR measurements taken over the time-course of treatment as a time-dependent covariate. PFS was defined as time from the start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as: an unequivocal and clinically meaningful increase in size of known tumors, appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. The association between longitudinal NLR (longitudinal NLR ≤5 vs N>5) and PFS was reported as hazard ratio.|Baseline up to disease progression, death or end of study (up to 4 years)|FAS population. “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||hazard ratio||95% Confidence Interval|Number
2659393|NCT01588990|Secondary|Association Between NLR Normalization (First NLR Post-Baseline ≤5 Versus NLR >5) and PFS as Assessed by Hazard Ratio|NLR was calculated from laboratory values as ratio of Neutrophils to Lymphocytes. NLR normalization was assessed by adding first post-baseline measurement of NLR to the primary model. This is equivalent to testing whether first change in NLR is significantly associated with outcome. PFS was defined as time from start of initial treatment to documentation of first disease progression or death from any cause. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was defined as: an unequivocal and clinically meaningful increase in size of known tumors, appearance of ≥1 new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration.The association between NLR normalization (first NLR post-baseline ≤5 vs >5) and PFS was reported as hazard ratio.|Baseline up to disease progression, death or end of study (up to 4 years)|FAS population. “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||hazard ratio||95% Confidence Interval|Number
2659395|NCT01588990|Secondary|Percentage of Participants Who Underwent Liver Resection: Overall|The results include percentage of participants who underwent potentially curative liver resection.|Baseline up to disease progression, death or end of study (up to 4 years)|FAS population.|||percentage of participants|||Number
2659396|NCT01588990|Secondary|Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Overall|Percentage of participants with best overall response of confirmed complete response or partial response based on the investigator assessment of the response as per routine clinical practice was reported. The confirmation of response must be no less than 4 weeks after initial assessment.|Baseline up to disease progression, death or end of study (up to 4 years)|FAS population.|||percentage of participants|||Number
2659397|NCT01588990|Secondary|Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Phase B|Percentage of participants with best overall response of confirmed complete response or partial response based on the investigator assessment of the response as per routine clinical practice was reported. The confirmation of response must be no less than 4 weeks after initial assessment.|From the start of Phase B treatment to disease progression, death or end of study (up to 4 years)|Phase B FAS population.|||percentage of participants|||Number
2659398|NCT01588990|Secondary|Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Phase A|Percentage of participants with best overall response of confirmed complete response or partial response based on the investigator assessment of the response as per routine clinical practice was reported. The confirmation of response must be no less than 4 weeks after initial assessment.|Baseline up to disease progression, death or end of study (up to 4 years)|FAS population.|||percentage of participants|||Number
2659399|NCT01588990|Secondary|OS: Phase B|Overall Survival in Phase B was defined as the time from the start of treatment in Phase B to death due to any cause. Kaplan-Meier methodology was used to estimate OS.|From the start of Phase B treatment death or end of study (up to 4 years)|Phase B FAS population.|||months||95% Confidence Interval|Median
2659400|NCT01588990|Secondary|Survival Beyond First Disease Progression: Overall|Survival beyond first progression was defined as the time from the date of first disease progression to death due to any cause. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate survival beyond first disease progression.|Baseline until death or end of study (up to 4 years)|FAS population. “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||months||95% Confidence Interval|Median
2659401|NCT01588990|Secondary|Overall Survival (OS) From the Start of Treatment to Study Completion: Overall|OS was defined as the time from the start of initial treatment to the date of death, regardless of the cause of death. Kaplan-Meier methodology was used to estimate OS.|Baseline until death or end of study (up to 4 years)|FAS population.|||months||95% Confidence Interval|Median
2659402|NCT01588990|Secondary|Duration of Disease Control (DDC) as Assessed by the Investigator Based on Routine Clinical Practice: Overall|DDC was defined as PFS + PFS-B. In cases where a participant did not enter Phase B, then DDC was defined as PFS. PFS was defined as time from start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. PFS-B was time from start of Phase B treatment to documentation of second disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate DDC.|Baseline up to disease progression, death or end of study (up to 4 years)|FAS population.|||months||95% Confidence Interval|Median
2659403|NCT01588990|Secondary|Time to Failure of Strategy (TFS): Overall|TFS was defined as time from the start of initial treatment to documentation of first disease progression without entering Phase B, or second disease progression having entered Phase B. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate TFS.|Baseline up to disease progression, death or end of study (up to 4 years)|FAS population.|||months||95% Confidence Interval|Median
2659404|NCT01588990|Secondary|PFS Until Second Disease Progression as Assessed by the Investigator Based on Routine Clinical Practice: Phase B|PFS in Phase B (PFS-B) was defined as the time from the start of Phase B treatment to documentation of second disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate PFS.|From the start of Phase B treatment to disease progression, death or end of study (up to 4 years)|Phase B FAS population included participants who received at least 1 dose of bevacizumab in Phase B.|||months||95% Confidence Interval|Median
2659432|NCT01588496|Secondary|Part B: Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 6 and 12||Baseline and Weeks 6 and 12|Part B full analysis set|||percent change||Standard Error|Least Squares Mean
2659433|NCT01588496|Secondary|Part B: Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Part B full analysis set|||percent change||Standard Error|Least Squares Mean
2659434|NCT01588496|Secondary|Part B: Percent Change From Baseline in LDL-C at the Mean of Weeks 6 and 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Weeks 6 and 12|Part B full analysis set|||percent change||Standard Error|Least Squares Mean
2659405|NCT01588990|Secondary|PFS Until First Disease Progression as Assessed by the Investigator Based on Routine Clinical Practice: Phase A|PFS until first progression was defined as the time from the start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate PFS.|Baseline up to first disease progression, death or end of study (up to 4 years)|FAS population.|||months||95% Confidence Interval|Median
2659406|NCT01588990|Primary|Association Between Neutrophil to Lymphocyte Ratio (NLR) [NLR ≤5 Versus NLR >5] and Progression-Free Survival (PFS) as Assessed by Hazard Ratio|NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. PFS was defined as the time from the start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (carcinoembryonic antigen [CEA]) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. The association between NLR (NLR less than or equal to [≤] 5 vs greater than [>] 5) and PFS was reported as hazard ratio.|Baseline up to disease progression, death or end of study (up to 4 years)|FAS population. “Overall Number of Participants Analyzed” = participants who were evaluable for this outcome.|||hazard ratio||95% Confidence Interval|Number
2659407|NCT01588951|Primary|Relapse Free Survival|Percentage of participants alive and without relapsed disease at two years.|2 years||||percentage of participants|||Number
2659408|NCT01588821|Secondary|Time to SRE|Time to SRE in patients treated with cabozantinib (SRE defined as pathologic fracture, cord compression, radiation or surgery to bone, hypercalcemia)|2 years||2020-05-31|05/2020||||
2659409|NCT01588821|Secondary|Response to Cabozantinib in Bone Metastatic Disease|Response to cabozantinib in bone metastatic disease as measured by bone scan or PET-CT scan|2 years||2020-05-31|05/2020||||
2659410|NCT01588821|Secondary|MET Amplification in Tumor Sample|Response will be correlated with specific tumor genotype (MET amplification).|2 years||2020-05-31|05/2020||||
2659411|NCT01588821|Secondary|Overall Tumor Response Rate|"The number of participants with a complete or partial response as measured by bone scan or PET-CT scan using. Response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.1).~Complete Response (CR): Disappearance of all target lesions~Partial Response (PR): At least a 30% decrease in the sum of the Longest Diameter (LD) of target lesions, taking as reference the baseline sum LD"|2 years|The 20 participants that were able to be evaluated for response. The other 17 participants had bone only disease|||Participants|||Count of Participants
2659412|NCT01588821|Secondary|Quality of Life|Quality of life as measured by pain and analgesic scores and the Functional Assessment of Cancer Therapy - General (FACT-G)|2 years||2020-05-31|05/2020||||
2659413|NCT01588821|Secondary|Rate of Skeletal-related Event (SRE)|Rate of SRE in patients treated with cabozantinib (SRE defined as pathologic fracture, cord compression, radiation or surgery to bone, hypercalcemia)|2 years||2020-05-31|05/2020||||
2659414|NCT01588821|Primary|Number of Participants With Bone Bio-marker Response|Effect of cabozantinib on bone biomarkers of osteoblast and osteoclast activity. The bio-markers of interest were serum C-terminal telopeptide (Ctx), urine N-terminal telopeptide (Ntx), serum (Ntx). Participants were considered to have a response if there was at least a 40% decrease in the bio-marker concentration.|8 Weeks|Only 19 participants were evaluable for determination of response by bone bio-markers|||Participants|||Count of Participants
2659415|NCT01588561|Secondary|Final Nicotine Levels|Final nicotine level in each participant|30 minutes post-infusion|One participant had incomplete serum nicotine results and was not included.|||ng/ml||Standard Deviation|Mean
2659416|NCT01588561|Secondary|Number of Brain Regions With a Change in Brain Activity Relative to Saline When Analyzed With Smoking History Controlling for Nicotine|PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with smoking history (pack years) controlling for nicotine. The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum—it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps.|40 minutes after infusion|The data from three subjects were not included in the imaging results, one due to incomplete serum nicotine results, one due to a misalignment of the head in the scanner, which resulted in incomplete brain coverage, and one subject had a combination of excessive motion and abnormal anatomy.|||brain regions|||Number
2659417|NCT01588561|Secondary|Number of Brain Regions With a Change in Brain Activity Relative to Saline When Analyzed With the Nicotine Time Course Controlling for Smoking History|"PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with the nicotine time course controlling for smoking history (pack years).~The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum—it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps."|40 minutes after infusion|The data from three subjects were not included in the imaging results, one due to incomplete serum nicotine results, one due to a misalignment of the head in the scanner, which resulted in incomplete brain coverage, and one subject had a combination of excessive motion and abnormal anatomy.|||brain regions|||Number
2659435|NCT01588496|Secondary|Part A: Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) at Week 12||Baseline and Week 12|Part A full analysis set|||ng/mL||Standard Error|Mean
2659418|NCT01588561|Primary|Number of Brain Regions With a Change in Brain Activity Relative to Saline|"PhMRI analysis of the differential response of nicotine compared to the saline condition when analyzed with the nicotine time course.~The main dependent variable in this study, Blood Oxygen Level Dependent (BOLD) measures of brain activity (via fMRI) data does not exist in a vacuum—it is always relative to another measure of brain activity, typically collected at rest or after a placebo injection. So we collected the data after the IV placebo injection alone and the IV nicotine injection alone, but then need applied mathematical CONTRASTS to the data. This procedure results in the brain activity maps."|40 minutes after infusion|The data from three subjects were not included in the imaging results, one due to incomplete serum nicotine results, one due to a misalignment of the head in the scanner, which resulted in incomplete brain coverage, and one subject had a combination of excessive motion and abnormal anatomy.|||brain regions|||Number
2659419|NCT01588561|Primary|Peak Nicotine Levels|Peak nicotine level in each participant|0, 2, 4, 6, 8, 10, 12, 14, 16, 20, 30 minutes post-infusion|Peak nicotine levels were only measured during the nicotine study intervention. One participant had incomplete serum nicotine results and was not included.|||ng/ml||Standard Deviation|Mean
2659420|NCT01588548|Primary|Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions (TL)s since baseline and any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of TLs; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD), at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm; Not Evaluable (NE), this is only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit, also note that if the sum of diameters meets the progressive disease criteria, progressive disease overrides not evaluable as a TL response. Best objective response is the best response a patient experiences over the randomised treatment period.|Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1|All patients who were evaluable for Response analysis set for RECIST criteria|||Participants|||Number
2659421|NCT01588509|Secondary|Mean Serum Concentration of Romosozumab||Days 4, 15, 29, 43, 57, 71 and 85|All participants who received study drug with available data at each time point.|||ng/mL||Standard Deviation|Mean
2659422|NCT01588509|Secondary|Number of Participants Who Developed Anti-romosozumab Antibodies|Two validated assays were used to detect the presence of anti-romosozumab antibodies. An electrochemiluminescent bridging immunoassay was used to detect binding antibodies (screening assay) and confirm antibodies (confirmatory assay) capable of binding romosozumab. Samples testing positive in the immunoassay were further tested in a competitive binding bioassay for neutralizing activity against romosozumab. If a sample was positive for binding antibodies and demonstrated neutralizing activity, the participant was defined as positive for neutralizing antibodies. Participants who developed anti-romosozumab antibodies were those with a negative result at baseline and a positive result at any time postbaseline.|Baseline and days 29, 57, and 85|All participants who received study drug|||Participants|||Count of Participants
2659423|NCT01588509|Secondary|Number of Participants With Adverse Events|"An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial participant.~Laboratory value changes that required treatment or adjustment in current therapy were considered adverse events.~A treatment-related adverse event (TRAE) was an adverse event assessed by the investigator as possibly related to the investigational product, indicated by a yes response to the question: Is there a reasonable possibility that the event may have been caused by the investigational product?~A serious adverse event was defined as an adverse event that met at least 1 of the following serious criteria:~fatal,~life-threatening,~required in-patient hospitalization or prolongation of existing hospitalization,~resulted in persistent or significant disability/incapacity,~congenital anomaly/birth defect, and/or~other medically important serious event."|From first dose of study drug up to day 85|All participants who received study drug|||Participants|||Count of Participants
2659424|NCT01588509|Secondary|Percent Change From Baseline in Serum C-telopeptide (sCTX)||Baseline and days 4, 15, 29, 43, 57, 71, and 85|All participants who received study drug and with available data at each time point|||percent change||Standard Error|Mean
2659425|NCT01588509|Secondary|Percent Change From Baseline in Serum Type-1 Aminoterminal Propeptide (P1NP)||Baseline and days 4, 15, 29, 43, 57, 71, and 85|All participants who received study drug and with available data at each time point|||percent change||Standard Error|Mean
2659426|NCT01588509|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) at the Total Hip|Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab.|Baseline and day 85|All participants who received study drug and with non-missing baseline and day 85 measurements.|||percent change||Standard Error|Mean
2659427|NCT01588509|Secondary|Percent Change From Baseline in Bone Mineral Density (BMD) at the Femoral Neck|Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans and analyzed by a central imaging lab.|Baseline and day 85|All participants who received study drug and with non-missing baseline and day 85 measurements.|||percent change||Standard Error|Mean
2659428|NCT01588509|Primary|Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine|Bone mineral density was assessed by dual energy X-ray absorptiometry (DXA) scans of the lumbar spine (L1-L4) and analyzed by a central imaging lab.|Baseline and day 85|All participants who received study drug and with non-missing baseline and day 85 measurements.|||percent change||Standard Error|Mean
2659429|NCT01588496|Primary|Part B: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was quantified using the ultracentrifugation method.|Baseline and Week 12|Part B full analysis set (all enrolled participants who received at least 1 dose of investigational product)|||percent change||Standard Error|Least Squares Mean
2659430|NCT01588496|Secondary|Part B: Percent Change From Baseline in Lipoprotein (a) at the Mean of Weeks 6 and 12||Baseline and Weeks 6 and 12|Part B full analysis set|||percent change||Standard Error|Least Squares Mean
2659431|NCT01588496|Secondary|Part B: Percent Change From Baseline in Lipoprotein (a) at Week 12||Baseline and Week 12|Part B full anlaysis set|||percent change||Standard Error|Least Squares Mean
2659443|NCT01588470|Secondary|Change in Hemoglobin A1c|Change in hemoglobin A1c levels measured at 6 months|Baseline and 6-months Post Treatment|Enrolled subjects that meet eligibility criteria as type 2 diabetics or non diabetic subjects with coronary heart disease|||percent||Standard Deviation|Mean
2659444|NCT01588470|Primary|Myocardial Glucose Uptake|Measurement of change in myocardial glucose uptake from baseline to 6 months of treatment with pitoglitazone|Baseline and 6-months Post Treatment|Study participants who met eligibility criteria|||uM/min/g||Standard Deviation|Mean
2659445|NCT01588470|Primary|Change in E to A Ratio|The E to A ratio is a marker of the function of the left ventricle of the heart. It represents the ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by the atrial contraction (the A wave) This is measured using ultrasound-based cardiac imaging. In a healthy heart the E velocity is greater than the A velocity.|Baseline and 6-months Post Treatment||||Ratio||Standard Deviation|Mean
2659446|NCT01588444|Primary|Histologic Percentage of Vital Bone Formation|Histologic percentage of vital bone formation in bone cores|18-20 weeks after grafting||||percentage of vital bone||Inter-Quartile Range|Median
2659447|NCT01588418|Secondary|Effect of Exenatide on the Liver and Adipose Tissue Glucose Uptake|we evaluated the acute effects of exenatide on hepatic (Hep-IR) and adipose (Adipo-IR) insulin resistance and glucose uptake.|60 minutes after exenatide or placebo injection|Outcome data was not collected||||||
2659448|NCT01588418|Primary|Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism|To study the acute effect of exenatide on brain glucose metabolism after the glucose load. Brain glucose uptake will be determined from serial FDG PET-imaging, by using graphical methods to quantify both global and regional results. The results obtained after Exenatide injection will be compared with the ones obtained after injection of placebo in the same subject.|120 minutes after exenatide or placebo injection|We studied, in the same subject, the acute effect of injection of exenatide vs placebo on brain glucose metabolism (CMRglu) after the glucose load. We used FDG PET-imaging to quantify global and regional results.|||μmol/(ml*min)||Standard Error|Mean
2659449|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance (PVR) (mmHg*Min/L)|pulmonary vascular resistance (PVR) is the resistance the right ventricle must overcome to pump blood into the pulmonary arteries. The change in PVR values from Baseline to Week 24 at peak exercise were measured by Swan-Ganz right heart catheterization.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.|||mmHg*min/L||Standard Deviation|Mean
2659450|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance Index (PVRI) (mmHg*Min*m^2/L)|Pulmonary Vascular Resistance Index (PVRI) is calculated using Mean Pulmonary Arterial Pressure(PAPm), Pulmonary Capillary Wedge Pressure (PCWP) and Cardiac Index (CI ), to provide information about right ventricular overload. The PVRI values and their respective changes from Baseline to Week 24 at peak exercise was measured by Swan-Ganz right heart catheterization.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.|||mmHg*min*m^2/L||Standard Deviation|Mean
2659451|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Index (CI) (L/Min/m^2)|Cardiac Index (CI) relates the cardiac output (CO) from left ventricle to body surface area (BSA), thus relating heart performance to the size of the individual. The CI values and their respective changes from Baseline to Week 24 at peak exercise was measured by Swan-Ganz right heart catheterization.|Baseline and week 24|Both the Thermodilution (n=6) and Fick (n=29) methods were used to determine CO and in some cases both methods were utilized; however, only the Fick method was used for (CI) for the purpose of this analysis and included only 29 subjects.|||L/min/m^2||Standard Deviation|Mean
2659452|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Output (CO) (L/Min)|Cardiac Output (CO) is the volume of blood ejected by the heart per minute, as measured by right heart catheterization. The value and change from Baseline to Week 24 at peak exercise was measured by Swan-Ganz right heart catheterization.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.|||L/min||Standard Deviation|Mean
2659453|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Arterial Oxygen Saturation (SaO2) (%) and Mixed Venous Oxygen Saturation (SvO2) (%)|SaO2 measured by Arterial Blood Draw and Blood Gas Analyzer and SvO2 measured via Pulmonary Artery Catheter, are both Hemodynamics Parameters collected during right heart catheterization. Mixed venous oxygen saturation (SvO2) can help to determine whether the cardiac output and oxygen delivery is high enough to meet a patient's needs|Baseline and Week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.|||Percent of Oxygen saturation||Standard Deviation|Mean
2659454|NCT01588405|Secondary|Change From Baseline to Week 24 in Hemodynamics Parameters: Mean Pulmonary Artery Pressure (PAPm), Mean Right Atrial Pressure (RAPm) and Mean Pulmonary Capillary Wedge Pressure (PCWPm)|Pulmonary hypertension (PH) is an increase in pressure in the pulmonary vasculature defined as a mean pulmonary artery pressure (PAPm) greater than 25 mmHg at rest or greater than 30 mmHg with exercise, as measured by right heart catheterization. Right Atrial Pressure (RAP) is the pressure of blood in the right atrium of the heart. Pulmonary Capillary Wedge Pressure (PCWP) is used to calculated pulmonary vascular resistance and can help guide therapeutic efficacy. The PAPm, RAPm and PCWPm values and their respective changes from Baseline to Week 24 at peak exercise were measured by Swan-Ganz right heart catheterization.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo these assessments. As such, the evaluable data at Week 24 was summarized using an N of 30 subjects, which is why the number of participants analyzed is inconsistent with the participant flow module.|||mmHg||Standard Deviation|Mean
2659466|NCT01588366|Secondary|Change From Baseline to Day 29 in Glucose Response to an Arginine Stimulation Test (AST) (Part A)|Acute glucose response to an AST at a blood glucose level of approximately 250 milligrams per deciliter (mg/dL).|Baseline, Day 29|Zero participants were analyzed for this outcome measure because glucose response data was not collected or included in the data analysis plan.||||||
2659467|NCT01588366|Secondary|Change From Baseline to Day 28 in Transaminase Levels||Baseline, Day 28|All participants who had evaluable transaminase levels at Baseline and on Day 28.|||units per liter (U/L)||Standard Deviation|Mean
2659455|NCT01588405|Secondary|Change From Baseline to Week 24 in Pharmacokinetics Parameters: Area Under the Plasma Concentration Curve (AUC) [h(ng/mL)]|Treprostinil pharmacokinetics (PK) were evaluated on two occasions during this study, once while the subject was still receiving Remodulin and again at Week 24 when the subject was receiving a stable dose of oral treprostinil. Blood samples were scheduled to be drawn from each subject initially at time 0 and the following subsequent times: 2, 4, 5, 6, 8, 10 and 12 hours after time of study drug administration (time 0) for a total of eight samples.|Baseline and Week 24|The number of participants analyzed is inconsistent with participant flow because it includes data from an early termination patient. A pharmacokinetics sample collected at early termination was included in the analysis.|||[h(ng/mL)]||Full Range|Median
2659456|NCT01588405|Secondary|Change From Baseline to Week 24 in Pharmacokinetics Parameter: Peak Time to Reach Peak Plasma Concentration [Tmax (h)]|Treprostinil pharmacokinetics (PK) were evaluated on two occasions during this study, once while the subject was still receiving Remodulin and again at Week 24 when the subject was receiving a stable dose of oral treprostinil. Blood samples were scheduled to be drawn from each subject initially at time 0 and the following subsequent times: 2, 4, 5, 6, 8, 10 and 12 hours after time of study drug administration (time 0) for a total of eight samples.|Baseline and Week 24|Dosing frequency was modified for BID to TID during the study, reported separately for patients on BID vs TID dosing at week 24. The number of participants analyzed is inconsistent with participant flow because it includes data from an early termination patient. A pharmacokinetics sample collected at early termination was included in the analysis.|||[Tmax (h)]||Full Range|Mean
2659457|NCT01588405|Secondary|Change From Baseline to Week 24 in Pharmacokinetic Parameters: Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), and Trough Plasma Concentration (Cmin)|Treprostinil pharmacokinetics (PK) were evaluated on two occasions during this study, once while the subject was still receiving Remodulin and again at Week 24 when the subject was receiving a stable dose of oral treprostinil. Blood samples were scheduled to be drawn from each subject initially at time 0 and the following subsequent times: 2, 4, 5, 6, 8, 10 and 12 hours after time of study drug administration (time 0) for a total of eight samples.|Baseline and Week 24|Dosing frequency was modified for BID to TID during the study, reported separately for patients on BID vs TID dosing at week 24. The number of participants analyzed is inconsistent with participant flow because it includes data from an early termination patient. A pharmacokinetics sample collected at early termination was included in the analysis.|||(ng/mL)||Full Range|Median
2659458|NCT01588405|Secondary|Change in Dyspnea-fatigue Index From Baseline to Week 24|The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best.|Baseline and Week 24||||units on a scale||Full Range|Median
2659459|NCT01588405|Secondary|Change in World Health Organization (WHO) Functional Classification From Baseline to Week 24|Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms.|Baseline and Week 24|The World Health Organization (WHO) Functional Classification was only conducted at baseline for one subject, because the subject discontinued the study prior to the collection of this assessment at the next visit. One subject had this assessment prior to study discontinuation.|||participants|||Number
2659460|NCT01588405|Secondary|Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 24|The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning) and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements.|Baseline and week 24||||units on a scale||Full Range|Median
2659461|NCT01588405|Secondary|Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 24|The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea (difficulty in breathing) experienced during the six-minute walk test (6MWT). The Borg dyspnea score was assessed immediately following the 6MWT. Scores ranged from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced).|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.|||units on a scale||Full Range|Median
2659462|NCT01588405|Secondary|Change From Baseline in Six-minute Walk Distance at Week 24|The purpose of the 6MWT is to evaluate exercise capacity associated with carrying out activities of daily living. Patients were instructed to walk down a corridor at a comfortable speed as far as they could manage for six minutes, resting whenever they needed. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation.|Baseline and week 24|One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects.|||meters||Full Range|Median
2659463|NCT01588405|Primary|Number of Participants That Were Succesfully Transitioned From Parenteral Remodulin to UT-15C.|Successful transition was based on the number of participants that completely transitioned to oral treprostinil by the week 4 study visit and clinically maintained on oral treprostinil treatment through Week 24.|Up to 24 weeks||||participants|||Number
2659464|NCT01588366|Secondary|Change From Baseline to Day 29 in Insulin Response to an Arginine Stimulation Test (AST) (Part A)|Acute insulin response to an AST at a blood glucose level of approximately 250 mg/dL.|Baseline, Day 29|All participants in Part A who received 60 mg LY2409021 and had an evaluable insulin response at Baseline and on Day 29.|||pmol/L||95% Confidence Interval|Mean
2659465|NCT01588366|Secondary|Change From Baseline to Day 29 in Glucagon Response to an Arginine Stimulation Test (AST) (Part A)|Acute glucagon response to an AST at a blood glucose level of approximately 250 mg/dL.|Baseline, Day 29|All participants in Part A who received 60 mg LY2409021 and had an evaluable glucagon response at Baseline and on Day 29.|||pmol/L||95% Confidence Interval|Mean
2659468|NCT01588366|Primary|Change From Baseline to Day 28 in Hepatic Glycogen Content|Measured by MR scanning.|Baseline, Day 28 (Pre-meal)|All participants in Part A who received 60 mg LY2409021 and had evaluable MR scans at Baseline and on Day 28.|||millimoles per liter (mmol/L)||95% Confidence Interval|Mean
2659469|NCT01588366|Primary|Change From Baseline to Day 28 in Liver Fat Average Percent (%)|Measured by magnetic resonance (MR) scanning.|Baseline, Day 28 (Pre-meal)|All participants who had evaluable MR scans at Baseline and on Day 28.|||percentage of liver fat average||95% Confidence Interval|Mean
2659470|NCT01588353|Secondary|Time to First Achieve and Maintain Clinical Success After the Last Injection|"The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the time to first achieve and maintain clinical success after the last injection where clinical success was defined as reduction in the contracture of the first treated joint to 5° or less. The injection was allowed up to 3 times."|First evaluation visit on which clinical success is achieved and maintained through the Day 30 evaluation of each injections, assessed up to 3 months|The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.|||Days||Inter-Quartile Range|Median
2659471|NCT01588353|Secondary|Change From Baseline Range of Motion After the Last Injection|The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the change from baseline range of motion in primary joints after the last injection. The injection was allowed up to 3 times.|30 days after last treatment|The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.|||Degrees||Standard Deviation|Mean
2659472|NCT01588353|Secondary|Percent Reduction From Baseline Contracture After the Last Injection|The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the mean percent decrease from baseline degree of contracture in primary joints after the last injection. The injection was allowed up to 3 times.|30 days after last treatment|The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.|||% of change from baseline||Standard Deviation|Mean
2659473|NCT01588353|Secondary|Clinical Improvement After the Last Injection|"The Secondary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the percentage of 77 participants that were clinically improved where clinically improved was defined as reduction in the contracture of the first treated joint by 50% or more from the baseline. The injection was allowed up to 3 times."|30 days after the last injection|The secondary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.|||% Participants||95% Confidence Interval|Number
2659474|NCT01588353|Primary|"The Percentage of Participants That Were Successfully Treated With a Successful Reduction in Contracture to 5°or Less"|"The Primary Outcome Measure for participants who were enrolled at Step1 through Step2 and treated with AK160 is the percentage of 77 participants that were successfully treated where successfully treated was defined as reduction in the contracture of the first treated joint to 5° or less. The injection was allowed up to 3 times."|30 days after the last injection|The primary efficacy analysis population was the full analysis set (FAS) comprising subjects treated with study drug in Steps 1 and 2.|||% Participants|||Number
2659475|NCT01588236|Secondary|Subject's Overall Satisfaction at the End of the 3-cycle Follow-up Period|"The subject's evaluation of overall satisfaction was recorded in the electronic subject diary at the end of the 3 treatment cycles and at the end of the 3-cycle follow-up period (at the end of the day before the subject goes to bed) using the numeric rating scale provided below:~0=None, Not satisfied with the treatment outcome；~Mild, Mildly satisfied with the treatment outcome；~Most, Mostly satisfied with the treatment outcome；~Complete, Completely satisfied with the treatment outcome."|Base line and end of follow-up (9 months)|Full analysis set|||percentage of complete satisfaction|||Number
2659476|NCT01588236|Secondary|Rescue Medication Consumption at the End of Treatment and Follow-up Period|The change from baseline to the end of treatment and follow-up period in rescue medication consumption|Baseline, end of treatment (6 months) and end of follow-up (9 months)|FAS: all randomized subjects who received at least 1 dose of study treatments, and had at least 1 valid postbaseline assessment of dysmenorrheic pain VAS score|||pills||Standard Deviation|Mean
2659477|NCT01588236|Secondary|Average Daily Dysmenorrheic Pain VAS Score at the End of Treatment and Follow-up Period|"VAS is represented by a straight line with extreme limits: from no pain and an associated image of a happy face at the left endpoint to unbearable pain and an associated image of an unhappy face at the right endpoint. The left endpoint is the minimum pain score of zero while the right endpoint is the maximum pain score of 100.~The dysmenorrheic pain (lower abdominal cramping pain) that usually occurs just before and/or during menstruation was measured in this study using a The Visual Analogue Scale (VAS). Pain was assessed during 9 menstrual cycles from the beginning of the screening to the end of follow-up."|Baseline, end of treatment (6 months) and end of follow-up (9 months)|FAS: all randomized subjects who received at least 1 dose of study treatments, and had at least 1 valid postbaseline assessment of dysmenorrheic pain VAS score|||pills||Standard Error|Least Squares Mean
2659478|NCT01588236|Primary|The Number of Days of Dysmenorrheic Pain at the End of Follow-up Period Compared With Baseline|The change from baseline in the number of days with dysmenorrheic pain at the end of a 3-cycle follow-up period|Baseline and end of follow-up (9 months)|FAS: all randomized subjects who received at least 1 dose of study treatments, and had at least 1 valid postbaseline assessment of dysmenorrheic pain VAS score|||days||Standard Error|Least Squares Mean
2659479|NCT01588236|Primary|The Change From Baseline to the End of Follow-up Period in the Maximum VAS Score|"VAS is represented by a straight line with extreme limits: from no pain and an associated image of a happy face at the left endpoint to unbearable pain and an associated image of an unhappy face at the right endpoint. The left endpoint is the minimum pain score of zero while the right endpoint is the maximum pain score of 100.~The dysmenorrheic pain (lower abdominal cramping pain) that usually occurs just before and/or during menstruation was measured in this study using a The Visual Analogue Scale (VAS). Pain was assessed during 9 menstrual cycles from the beginning of the screening to the end of follow-up."|Baseline and end of follow-up (9 months)|FAS: all randomized subjects who received at least 1 dose of study treatments, and had at least 1 valid postbaseline assessment of dysmenorrheic pain VAS score|||unit of a scale||Standard Error|Least Squares Mean
2659480|NCT01588236|Primary|The Change From Baseline in Number of Days With Dysmenorrheic Pain at the End of Treatment|The change from baseline in number of days with dysmenorrheic pain at the end of 3 treatment cycles|Baseline and end of treatment (6 months)|Full analysis set: all randomized subjects who received at least 1 dose of study treatments, and had at least 1 valid postbaseline assessment of dysmenorrheic pain VAS score|||days||Standard Error|Least Squares Mean
2659481|NCT01588236|Primary|The Change From Baseline to the End of Treatment Period in Maximum Dysmenorrheic Pain VAS Score|"VAS is represented by a straight line with extreme limits: from no pain and an associated image of a happy face at the left endpoint to unbearable pain and an associated image of an unhappy face at the right endpoint. The left endpoint is the minimum pain score of zero while the right endpoint is the maximum pain score of 100.~The dysmenorrheic pain (lower abdominal cramping pain) that usually occurs just before and/or during menstruation was measured in this study using a The Visual Analogue Scale (VAS). Pain was assessed during 9 menstrual cycles from the beginning of the screening to the end of follow-up."|Baseline and end of treatment (6 months)|Full analysis set: all subjects who received at least one treatment dose and had one post-baseline assessment|||units on a scale||Standard Error|Least Squares Mean
2659482|NCT01588197|Primary|Ability to Distract|"All participants will undergo thermal pain threshold testing before and after fMRI paradigm. Participants will rate the ability to distract themselves from the thermal stimuli, on a scale of 0-10, before fMRI paradigm (Baseline) and after fMRI paradigm, 0=not able to distract at all and 10=completely able to distract. A Higher rating represents greater ability to distract from thermal pain stimuli."|Before and After fMRI Paradigm, an average of 2 hours||||units on a scale||Standard Deviation|Mean
2659483|NCT01588197|Primary|Average Pain Rating|"All participants will undergo thermal pain threshold testing directly before (Baseline) and after MRI scan.Participants will be asked to rate painfulness of the thermal stimuli applied, on a scale of 0-10, before the fMRI Paradigm (Baseline) and directly after the fMRI paradigm (after MRI). 0=no pain and 10=worst pain imaginable"|Before and After fMRI Paradigm, an average of 2 hours||||units on a scale||Standard Deviation|Mean
2659484|NCT01588197|Primary|Average Unpleasantness|"All participants will undergo thermal pain threshold testing directly before (Baseline) and after MRI. Participants will be asked to rate pain unpleasantness, on a scale of 0-10, before the fMRI Paradigm (Baseline) and directly after the fMRI paradigm (after MRI).~0=no unpleasantness and 10=worst unpleasantness imaginable"|Before and After fMRI Paradigm, an average of 2 hours||||units on a scale||Standard Deviation|Mean
2659485|NCT01588158|Secondary|Pain Scale|11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had.|At the follow-up 2 weeks after the surgery with suture removal||||units on a scale||Standard Deviation|Mean
2659486|NCT01588158|Secondary|QuickDASH|The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.|At the follow-up 2 weeks after the surgery with suture removal||||units on a scale||Standard Deviation|Mean
2659487|NCT01588158|Secondary|Pain Scale|11-point ordinal pain scale to assess the amount of pain. The scale range is from 0-10, where 0 is no pain at all and 10 is the worst pain ever had.|At enrollment prior to surgery||||units on a scale||Standard Deviation|Mean
2659488|NCT01588158|Secondary|Expectation of Pain Relief|An 11-point ordinal scale to assess the expectation of how well the pain medication will work after surgery. The scale range is from 0-10, where 0 is not effective at all and 10 is completely effective.|1 day||||units on a scale||Standard Deviation|Mean
2659489|NCT01588158|Secondary|Pain Patients Expect After Surgery|an 11-point ordinal scale to assess the amount of pain the patients expect after surgery. The scale range is from 0-10, where 0 is no pain expected and 10 is the worst pain expected|1 day||||units on a scale||Standard Deviation|Mean
2659490|NCT01588158|Secondary|PHQ-9|Patient Health Questionnaire-9 to assess symptoms of depression. The scale range is from 0-27, where 0 is no symptoms of depression and 27 is severe depression.|1 day||||units on a scale||Standard Deviation|Mean
2659491|NCT01588158|Secondary|PSEQ|The pain self efficacy questionnaire measures a patient's belief about his/her ability to complete a task despite his/her pain. The scale range is from 0-60, where 60 represents higher self-efficacy beliefs.|1 day||||units on a scale||Standard Deviation|Mean
2659492|NCT01588158|Secondary|QuickDASH|The short form of the Disabilities of Arm Shoulder and Hand to assess upper extremity disability. The scale range is from 0-100, where 0 is no difficulty performing tasks and 100 is the most difficulty or unable to complete any tasks.|At enrollment prior to surgery|Due to early termination of the study, the participants were not analyzed so we do not have data to enter in the outcome measure data table.|||units on a scale||Standard Deviation|Mean
2659493|NCT01588158|Primary|Satisfaction With Pain Relief|an 11-point ordinal scale to ask for the satisfaction of the patients with pain relief. The scale range is from 0-10, where 0 is complete dissatisfaction with pain relief and 10 is complete satisfaction.|at the follow-up, 2 weeks after the operation with suture removal||||units on a scale||Standard Deviation|Mean
2659494|NCT01588106|Primary|Reduction in HbA1c||Baseline, after 9 months|All participants from whom HbA1c measurements were recorded at baseline and after 9 months.|||% (unit of HbA1c)||Standard Deviation|Mean
2659495|NCT01587989|Secondary|Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score|TSQM scores were obtained by scoring participants' responses to a 14-item questionnaire. TSQM evaluated 4 aspects of treatment satisfaction: effectiveness, side effects, convenience, and global satisfaction from a range of 0 to 100 percent (%), with 100% being the best possible result.|Week 24|ITT population|||score on a scale||Standard Deviation|Mean
2659496|NCT01587989|Secondary|Change From Week 12 (Randomization) to Week 24 in Visual Analog Scales (VAS) Scores|VAS scores were obtained by scoring participants' disease activity as assessed on a 0-100 millimeter (mm) horizontal visual scale. The left-hand extreme of the line = 0 mm (no disease activity = symptom-free and no arthritis symptoms), and the right-hand extreme of the line = 100 mm (maximum disease activity). A negative change from randomization indicated improvement.|Weeks 12 and 24|ITT population|||score on a scale||Standard Deviation|Mean
2659760|NCT01586364|Primary|Change From Baseline in Erythrocyte Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.|||(x10(12)/L)||Standard Deviation|Mean
2659497|NCT01587989|Secondary|Change From Week 12 (Randomization) to Week 24 in Short Form-36 Health Survey (SF-36) Score|SF-36 scores were obtained by scoring participants' responses to a 36-item questionnaire. SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst). The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). These 8 aspects were summarized as physical and mental component scores. A negative change from randomization indicated improvement.|Weeks 12 and 24|ITT population|||score on a scale||Standard Deviation|Mean
2659498|NCT01587989|Secondary|Change From Week 12 (Randomization) to Week 24 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score|HAQ-DI scores were obtained by scoring participants' responses to a 20-item questionnaire. HAQ-DQ evaluated 8 domains of health: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities from a range of 0 (without any difficulty) to 3 (unable to do). The sum of scores was divided by the number of domains for a total score of 0 (best) to 3 (worst). A negative change from randomization indicated improvement.|Weeks 12 and 24|ITT population|||score on a scale||Standard Deviation|Mean
2659499|NCT01587989|Secondary|Percentage of Participants With Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) Remission at Week 24|The RADAI-5 is a combined index for measuring disease activity in RA. RADAI-5 is comprised of the following 5 questions: how active was your arthritis the last 6 months? (0 = completely inactive to 10 = extremely active); how active is your arthritis today with respect to joint tenderness and swelling? (0 = completely inactive to 10 = extremely active); how severe is your arthritis pain today? (0 = no pain to 10 = unbearable pain); how would you describe your general health today? (0 = very good to 10 = very bad); and did you experience joint (hand) stiffness on awakening yesterday morning? If yes, how long did this stiffness last? (0 = no stiffness to 10 = stiffness the whole day). RADAI was calculated according to the following formula: [question (Q) 1 + Q2 + Q3 + Q4 + Q5]/5. RADAI-5 from 0-1.4 = remission.|Week 24|ITT population|||percentage of participants|||Number
2659500|NCT01587989|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 24|The SDAI is a combined index for measuring disease activity in RA. SDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), PGA and EGA of disease activity, both scored 0 to 10 cm as assessed by VAS, and C-reactive protein level (CRP) in milligrams per deciliter (mg/dL) where normal < 1 mg/dL. CDAI was calculated according to the following formula: SDAI = TJC + SJC + PGA + EGA + CRP. SDAI < 3.3 = remission.|Week 24|ITT population|||percentage of participants|||Number
2659501|NCT01587989|Secondary|vPercentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24|The CDAI is a combined index for measuring disease activity in RA. CDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), as well as patient global assessment (PGA) and evaluator global assessment (EGA) of disease activity, both scored 0 to 10 centimeter (cm) as assessed by VAS. CDAI was calculated according to the following formula: CDAI = SJC + TJC + PGA + EGA. CDAI < 2.8 = remission.|Week 24|ITT population|||percentage of participants|||Number
2659502|NCT01587989|Secondary|Percentage of Participants With DAS28 Remission at Week 24|The DAS28 is a combined index for measuring disease activity in RA. The index includes SJC and TJC, both scored 0-28 (higher scores indicate higher disease activity, as well as APR determined as ESR, and GH, both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 = 0.56 * √ of TJC + 0.28 * √ of SJC + 0.70 * ln ESR mm/hr + 0.014 * GH in mm VAS. DAS28 < 2.6 = remission.|Week 24|ITT population|||percentage of participants|||Number
2659503|NCT01587989|Primary|Change From Week 12 (Randomization) to Week 24 in DAS28|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR), and general health (GH), both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + (0.70 * the natural logarithm (ln) ESR in millimeters per hour (mm/h)] + [0.014 * GH in mm visual analogue assessment (VAS)]. A negative change from randomization indicated improvement.|Weeks 12 and 24|ITT population|||score on a scale||Standard Deviation|Mean
2659504|NCT01587963|Primary|Efficacy of High Dose Vitamin C Therapy in Shock Patients|Given the grim prognosis of septic and hypovolemic shock, we aim to study the efficacy on an alternative treatment modality by implementing high dose vitamin C therapy in our patient population. Through previous investigations, especially research in the burn patient population, we expect that high dose vitamin C therapy will be beneficial to patients with hypovolemic or septic shock.|30 days|Study terminated prior to data collection completion. No data analysis performed.||||||
2659505|NCT01587950|Primary|Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 20 Minute Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 20 minutes post treatment.|Baseline, 20 minutes post administration of treatment|ITT population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to missing values, there were differences in number of participant analyzed per treatment group.|||Units on a scale||95% Confidence Interval|Mean
2659506|NCT01587950|Primary|Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 10 Minutes Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 10 minutes post treatment.|Baseline, 10 minutes post administration of treatment|ITT population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to missing values, there were differences in number of participant analyzed per treatment group.|||Units on a scale||95% Confidence Interval|Mean
2659507|NCT01587950|Primary|Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a Visual Analogue Scale (VAS) Immediately Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water|Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score immediately post treatment.|Baseline, immediately post administration of treatment|Intent to treat (ITT) population: All randomized subjects with at least one post baseline assessment of efficacy were included in analysis. Missing data was not imputed. Due to drop outs, there was difference in number of participant analyzed.|||Units on a scale||95% Confidence Interval|Mean
2659508|NCT01587924|Secondary|Number of Participants With Electrocardiogram (ECG) Findings Over Period|Participants were analyzed for any abnormality in ECG and was categorized as abnormal clinically significant and abnormal and clinically insignificant. The parameters that were analyzed for ECG were atrial fibrillation, Atrial premature complex, Bigeminy, First degree AV block (PR interval > 200 msec), Incomplete right bundle branch block, Junctional rhythm, Junctional tachycardia (heart rate >100 beats/min), Left anterior hemi block (synonymous to left anterior fascicular block), Left atrial abnormality, Left axis deviation (QRS axis more negative than -30 degrees), Left bundle branch block, Left ventricular hypertrophy, Myocardial infarction, anterior, Myocardial infarction, inferior, Non-specific ST-T changes, Normal sinus rhythm, Poor R wave progression, Right atrial abnormality, Right QRS axis deviation, bundle block, ventricular hypertrophy, ST depression or abnormality, AV block, arrhythmia, short PR interval, bradycardia, tachycardia, and T-wave abnormality.|Up to 6 weeks|Safety population. Only the participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
2659509|NCT01587924|Secondary|Number of Participants With Abnormal Vital Signs of PCI|Vital signs include systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR). Three measurements of SBP, DBP and HR were recorded from the participant in a supine position for at least 5 minutes (allowing enough time between measurement to completely deflate and loosen the inflatable cuff). Data has been presented for vital signs with values high and low from the reference range.|Up to 6 weeks|Safety population. Only the participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
2659510|NCT01587924|Secondary|Number of Participants With Abnormal Hematology and Clinical Chemistry Parameters of Potential Clinical Concern (PCI)|Participants were analyzed up to 6 weeks for hematological and clinical chemistry parameters of PCI whether they had any higher or lower values than the reference range post screening. Normal alkaline phosphatase (ALP) was 0-46 U/L, aspartate amino transferase (AST) 0-42 U/L, ALP 20-125 U/L, total bilirubin 0-1.3 mg/dL, troponin 0-0.1ng/mL, Hgb 12 - 16 g/dL, platelets 140-450 G/L, creatine phosphokinase 29-168 U/L, creatinine 0.57 - 1.25 mg/dL, Potassium 3.6-5.0 mmol/L, hematocrit 38-45%; however, no participants with abnormal hematology and clinical chemistry parameters were recorded.|Up to 6 weeks (including follow-up)|Safety population included all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2659511|NCT01587924|Secondary|Mean Plasma Concentration of GSK1278863 and GSK1278863 Metabolites Over 4 Weeks|Each of the plasma concentration-time plot contained one plot on the untransformed scale (i.e. a linear plot) and one plot on the log transformed scale (i.e. log-linear plot). Plasma concentrations were analyzed for the study drug (GSK1278863), and its metabolites namely GSK2391220 (M2), GSK2531403 (M3), GSK2487818A (M4), GSK2506102A (M5), GSK2531398 (M6), and GSK2531401A (M13). Pharmacokinetic analysis was done on Weeks (W) 2 and 4 at a fixed timely interval of 5 hours (h) on W2 and every hour on W4. Only the data for last visit for W2 and last visit of W4 has been presented.|Up to 4 weeks|Pharmacokinetic (PK) population included all the participants who received at least one dose of the study drug and from whom at least one sample was withdrawn for PK analysis. Only those participants available at the specified time points were analyzed.|||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2659512|NCT01587924|Secondary|Number of Participants Discontinuing the Study Treatment Due to AEs|Discontinuation of the study drug could be due to safety-related reasons AE. The AEs responsible included anemia, gastrointestinal hemorrhage, and nausea.|Up to 4 weeks|Safety population|||Participants|||Count of Participants
2659513|NCT01587924|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. An SAE is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above. Only on-treatment data has been presented.|Up to 4 weeks|Safety population.|||Participants|||Count of Participants
2659514|NCT01587924|Secondary|Number of Participants Reaching Hgb Stopping Criteria|Participants were analyzed whether they had any increase or decrease from the Baseline Hgb. Hgb increase based stopping criteria included analysis of Increase or decrease of more than or equal to (>=) 2 g/dL from the Baseline (pre-dose on Day 1) was recorded and also the participants with hemoglobin >=13 g/dL were recorded.|Up to 4 weeks|ITT population. Only those participants available at the time of assessment were analyzed.|||Participants|||Count of Participants
2659515|NCT01587924|Secondary|Change From Baseline (Pre-dose on Day 1) for Reticulocytes Over 4 Weeks|Evaluation of change from Baseline for reticulocytes was a PD parameter. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline value was recorded pre-dose on Day 1.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Percentage change||Standard Deviation|Mean
2659516|NCT01587924|Secondary|Change From Baseline (Pre-dose on Day 1) for Red Blood Cells (RBCs) Over 4 Weeks|Change from Baseline in RBCs was a pharmacodynamic (PD) biomarker. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was recorded pre-dose on Day 1. Change from Baseline (pre-dose on Day 1) in RBCs was calculated over 4 weeks.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||10^12 cells per Liter (Giga cells per L)||Standard Deviation|Mean
2659517|NCT01587924|Secondary|Change From Baseline (Pre-dose on Day 1) in Total Iron Binding Capacity Over 4 Weeks|Evaluation of change from Baseline in total iron binding capacity was performed over 4 weeks. Baseline was recorded pre-dose on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Adjusted means are presented as LS means.|Baseline (pre-dose on Day 1) and Week 4|ITT population. Only those participants available at the specified time points were analyzed.|||Micromoles per Liter||Standard Error|Least Squares Mean
2659518|NCT01587924|Secondary|Change From Baseline (Pre-dose on Day 1) for Total Iron Over 4 Weeks|Evaluation of change from Baseline for total iron was performed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was recorded pre-dose on Day 1. Adjusted mean was presented as LS mean.|Baseline (pre-dose on Day 1) and at Week 4|ITT population. Only those participants available at the specified time points were analyzed.|||Micromoles per Liter||Standard Error|Least Squares Mean
2659519|NCT01587924|Secondary|Change From Baseline (Pre-dose on Day 1) for Transferrin Saturation Over 4 Weeks|Transferrin saturation is a medical laboratory test and is the ratio of serum iron and total iron-binding capacity, multiplied by 100 and expressed as a ratio. Evaluation of change from baseline for transferrin saturation was performed up to 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline value was recorded pre-dose on Day 1. Model adjusted mean values are presented as LS mean values.|Baseline (pre-dose on Day 1) and Week 4|ITT population. Only those participants available at the specified time points were analyzed..|||Ratio||Standard Error|Least Squares Mean
2659520|NCT01587924|Secondary|Evaluation of Change From Baseline (Pre-dose on Day 1) for Transferrin Over 4 Weeks|Evaluation of change from Baseline for ferritin was performed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Model adjusted mean has been presented as LS mean.|Baseline (pre-dose on Day 1) and Week 4|ITT population. Only those participants available at the specified time points were analyzed.|||Grams per liter||Standard Error|Least Squares Mean
2659521|NCT01587924|Secondary|Evaluation of Change From Baseline (Pre-dose on Day 1) in Ferritin Over 4 Weeks|Change from Baseline (pre-dose on Day 1) in ferritin over 4 weeks was analyzed. Change from Baseline is the value at indicated time point minus the Baseline value. Model adjusted mean has been presented as LS mean.|Baseline (pre-dose on Day 1) and Week 4|ITT population. Only those participants available at the specified time points were analyzed.|||Micrograms per liter||Standard Error|Least Squares Mean
2659522|NCT01587924|Secondary|Number of Days Spent Within Hgb Range ( ±0.5 g/dL and ±1 g/dL ) From Baseline Hgb|Time spent with Hgb within range (where range was defined as +-0.5 g/dL and +-1 g/dL from baseline Hgb ) was analyzed. Baseline value of Hgb was recorded pre-dose on Day 1.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Days||Inter-Quartile Range|Median
2659523|NCT01587924|Secondary|Residual Standard Deviation in Hgb (From the Linear Regression)|Residual standard deviation was derived by linear regression. Hgb of participants was recorded over 4 weeks|Up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||g/L||Standard Deviation|Mean
2659524|NCT01587924|Secondary|Evaluation of Change From Baseline (Pre-dose on Day 1) for Hematocrit Over 4 Weeks|Evaluation of change from Baseline for hematocrit over 4 weeks was performed. Change from Baseline is the value at indicated time point minus the Baseline value.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Percentage||Standard Deviation|Mean
2659525|NCT01587924|Secondary|Evaluation of Change From Baseline (Pre-dose on Day 1) for Peak Vascular Endothelial Growth Factor (VEGF) Over 4 Weeks|Evaluation of change from Baseline for peak VEGF was analyzed up to 4 weeks. Baseline assessment was performed pre-dose on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Absolute mean change and peak change from Baseline in peak VGEF were also calculated; however, only model adjusted peak change in peak VGEF from Baseline has been presented as LS means.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Nanograms per liter (ng/L)||Standard Error|Least Squares Mean
2659526|NCT01587924|Secondary|Change From Baseline for Erythropoeitin (EPO) Over Period|Evaluation of change from Baseline (pre-dose on Day 1) for EPO was analyzed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was the pre-dose Day 1 value. Adjusted means are presented as LS means.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Units per liter (U/L)||Standard Error|Least Squares Mean
2659527|NCT01587924|Secondary|Evaluation of Change From Baseline (Pre-dose on Day 1) in High Sensitivity C-Reactive Protein (hsCRP) Over 4 Weeks|Evaluation of change from Baseline for hsCRP was analyzed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was the last pre-dose value. Peak change from Baseline also was calculated; however adjusted mean change from Baseline has been presented here as LS means.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Milligrams per liter (mg/L)||Standard Error|Least Squares Mean
2659528|NCT01587924|Secondary|Evaluation of Change From Baseline in Hepcidin Over Period|Evaluation of change from baseline for hepcidin was performed over 4 weeks. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was the last pre-dose value. Adjusted mean change from Baseline is presented as Least square (LS) mean.|Baseline (pre-dose on Day 1) and up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||Micrograms per liter (mcg/L)||Standard Error|Least Squares Mean
2659529|NCT01587924|Secondary|Hgb Variability Over 4 Weeks|Within participant standard deviation for Hgb acts as a measure of Hgb variability. Hgb of participants was recorded over 4 weeks.|Up to 4 weeks|ITT population. Only those participants available at the specified time points were analyzed.|||g/dL||Standard Deviation|Mean
2659540|NCT01587898|Secondary|Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6|Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 were reported.|Baseline (Day 1), Week 1, 2, 3, 4, and 6|Safety Population. Only those participants available at the specified time points were analyzed.|||FL||Standard Deviation|Mean
2659530|NCT01587924|Primary|Modeled Hemoglobin (Hgb) Change From Baseline (Pre-dose on Day 1) at 4 Weeks of Treatment|Modeled Hgb change from Baseline over 4 weeks of treatment. Change from Baseline is the actual value of Hgb at Week 4 minus the Baseline value. For modeled change at Week 4 participants required a Baseline and two or more non missing post-baseline values. Baseline is the average of Week -2, -1 and Day 1 values. The model included fixed effects for Baseline Hgb, treatment, and treatment by day interaction. Covariate analysis for modeled Hgb change was performed. Random effects were fitted in the intercept and the slope over time.|Baseline (pre-dose on Day 1) and up to week 4|ITT population. Only those participants available at the specified time points were analyzed.|||Grams per deciliter (g/dL)||Standard Deviation|Mean
2659531|NCT01587898|Secondary|Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites|Mean Steady state AUC of GSK1278863 and GSK1278863 metabolites (M1, M2, M3, M4, M5 and M6) were reported. For pharmacokinetic parameter assessment blood samples were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this fist sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose).|Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose)|Pharmacokinetic population.|||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2659532|NCT01587898|Secondary|Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites|Cmax of GSK1278863 and GSK1278863 metabolites (M1, M2, M3, M4, M5 and M6) were reported. For assessment of Pharmacokinetics parameters blood samples were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose).|Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose).|All participants from whom a pharmacokinetic sample had been obtained and analyzed were included in the pharmacokinetic population.|||nanogram per millilitre (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2659533|NCT01587898|Secondary|Change From Baseline in ECG Parameters at Week 2, 4 and 6|Full 12-lead ECGs were recorded in participants who were rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. Full 12-lead ECGs were recorded on the provided ECG machine that automatically calculates heart rate, PR, QRS, QT and QTc intervals. Baseline ECG values were defined as measurements taken at screening. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values.|Baseline (Screening), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||msec||Standard Deviation|Mean
2659534|NCT01587898|Secondary|Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6|Full 12-lead ECGs were recorded in participants who were rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. Full 12-lead ECGs were recorded on the provided ECG machine that automatically calculates heart rate, PR, QRS, QT and QTc intervals. Absolute ECG parameters including PR interval, QT interval and QRS duration values at Baseline (Screening), Week 2, 4, and 6 were reported.|Baseline (Screening), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||Milliseconds (msec)||Standard Deviation|Mean
2659535|NCT01587898|Secondary|Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6|Three measurements of heart rate were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff). Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. change from baseline in heart rate at Week 1, 2, 3, 4, and 6 were reported.|Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2659536|NCT01587898|Secondary|Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6|Absolute values of heart rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 were reported as vital parameter. Three measurements of heart rate were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff).|Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2659537|NCT01587898|Secondary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6|Three measurements of SBP and DBP were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff). Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in systolic blood pressure and diastolic blood pressure at Week 1, 2, 3, 4, and 6 were reported.|Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||mmHg||Standard Deviation|Mean
2659538|NCT01587898|Secondary|Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6|Absolute values of systolic blood pressure and diastolic blood pressure Baseline (Day 1), Week 1, 2, 3, 4, and 6 as vital parameters were reported. Three measurements of systolic blood pressure and diastolic blood pressure were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff).|Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||Millimeter mercury (mmHg)||Standard Deviation|Mean
2659539|NCT01587898|Secondary|Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6|Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 were reported.|Baseline (Day 1), Week 1, 2, 3, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||G/L||Standard Deviation|Mean
2659541|NCT01587898|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6|Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet count, WBC count (absolute) at Week 1, 2, 3, 4, and 6 were reported.|Baseline (Day 1), Week 1, 2, 3, 4, and 6|Safety Population. Only those participants available at the specified time points were analyzed.|||10^9 cells/L||Standard Deviation|Mean
2659542|NCT01587898|Secondary|Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6|Hematology parameter reticulocyte were assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).|Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2659543|NCT01587898|Secondary|Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6|Hematology parameter Mean Corpuscle Hgb Concentration was assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).|Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||G/L||Standard Deviation|Mean
2659544|NCT01587898|Secondary|Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6|Hematology parameter mean corpuscle volume was assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).|Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||Femtolitre (FL)||Standard Deviation|Mean
2659545|NCT01587898|Secondary|Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6|Hematology parameters including Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet count, WBC count (absolute) were assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).|Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||10^9 cells/L||Standard Deviation|Mean
2659546|NCT01587898|Secondary|Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6|Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of urine total protein/creatinine ratio at Week 2, 4, and 6 were reported.|Baseline (Day 1), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||MG/MMOL||Standard Deviation|Mean
2659547|NCT01587898|Secondary|Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6|Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of creatinine, direct bilirubin, indirect bilirubin, total bilirubin at Week 2, 4, and 6 were reported.|Baseline (Day 1), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||Micromol/L||Standard Deviation|Mean
2659548|NCT01587898|Secondary|Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6|Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of calcium, chloride, cholesterol, glucose, inorganic phosphorus, potassium, sodium at Week 2, 4, and 6 were reported.|Baseline (Day 1), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||MMOL/L||Standard Deviation|Mean
2659549|NCT01587898|Secondary|Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6|Baseline values were recorded on Day 1 (Pre dose). If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of albumin, apolipoprotein A1, apolipoprotein total, total protein at Week 2, 4, and 6 were reported.|Baseline (Day 1), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||G/L||Standard Deviation|Mean
2659550|NCT01587898|Secondary|Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6|Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the Baseline value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. Change from Baseline values of ALT, AST, ALP and CK at Week 2, 4, and 6|Baseline (Day 1), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||IU/L||Standard Deviation|Mean
2659551|NCT01587898|Secondary|Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6|Absolute values of urine total protein/creatinine ratio at Baseline (Day 1), Week 2, 4, and follow-up (week 6) were reported.|Baseline (Day 1), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||mg/MMOL||Standard Deviation|Mean
2659552|NCT01587898|Secondary|Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6|Clinical chemistry parameters including creatinine, direct bilirubin, indirect bilirubin, total bilirubin were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).|Baseline (Day 1 pre-dose), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||Micromol/L||Standard Deviation|Mean
2659587|NCT01587703|Secondary|Volume of Distribution of GSK525762-Part 1 QD|Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.|pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4|PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Liters||Geometric Coefficient of Variation|Geometric Mean
2659553|NCT01587898|Secondary|Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6|Clinical chemistry parameters including calcium, chloride, cholesterol, glucose, inorganic phosphorus, potassium, sodium were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).|Baseline (Day 1 pre-dose), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed.|||Millimol per Litre (MMOL/L)||Standard Deviation|Mean
2659554|NCT01587898|Secondary|Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6|Clinical chemistry parameters including albumin, apolipoprotein A1, apolipoprotein total, total protein were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).|Baseline (Day 1 pre-dose), Week 2, 4, and 6|Safety population. Only those participants available at the specified time points were analyzed|||G/L||Standard Deviation|Mean
2659555|NCT01587898|Secondary|Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6|Clinical chemistry parameters including ALT, ALP, AST, CK were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).|Baseline (Day 1 pre-dose), Week 2, 4, and 6|Safety Population. Only those participants available at the specified time points were analyzed.|||International Units per litre (IU/L)||Standard Deviation|Mean
2659556|NCT01587898|Secondary|Number of Participants Discontinuing the Study Treatment Due to AEs|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. number of participants discontinuing the study treatment due to AEs.|Up to 6 weeks|Safety Population|||Participants|||Count of Participants
2659557|NCT01587898|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Up to 6 weeks|The Safety Population comprised of all participants who received at least one dose of study medication.|||Participants|||Count of Participants
2659558|NCT01587898|Secondary|Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4|Blood samples for VEGF were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1 and 3 h after this fist sample) and Week 4 (Pre-dose and 3 h post-dose). Baseline was the Day 1 pre-dose value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values.|Baseline (Pre-dose), week 2 and 4|ITT population. Only those participants available at the specified time points were analyzed.|||Nanogram per litre (ng/L)||Standard Deviation|Mean
2659559|NCT01587898|Secondary|Change From Baseline in Red Blood Cells Count Over 4 Weeks|Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (Day 1 pre-dose), week 1, 2, 3, 4|ITT population. Only those participants available at the specified time points were analyzed.|||10^12 cells /L||Standard Deviation|Mean
2659560|NCT01587898|Secondary|Change From Baseline in Erythropoietin at Week 2 and Week 4|Blood samples for erythropoietin were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1 and 3 h after this fist sample) and Week 4 (Pre-dose and 3 h post-dose). The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (Day 1 Pre-dose), Week 2 and 4|ITT Population. Only those participants available at the specified time points were analyzed.|||Units per litre (U/L)||Standard Deviation|Mean
2659561|NCT01587898|Secondary|Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks|Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (Day 1 pre-dose), Week 1, 2, 3, and 4|ITT Population. Only those participants available at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2659562|NCT01587898|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 2 and Week 4|Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (Day 1 Pre-dose), Week 2 and 4|ITT population. Only those participants available at the specified time points were analyzed|||miligram per litre (mg/L)||Standard Deviation|Mean
2659563|NCT01587898|Secondary|Change From Baseline in Total Iron at Week 2 and Week 4|Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (Day 1 Pre-dose), Week 2 and 4|ITT Population. Only those participants available at the specified time points were analyzed.|||micromol/L||Standard Deviation|Mean
2659564|NCT01587898|Secondary|Change From Baseline in Total Iron Binding Capacity at Week 2 and Week 4|Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (Day 1 Pre-dose), Week 2 and 4|ITT population. Only those participants available at the specified time points were analyzed.|||Micromol per litre (micromol/L)||Standard Deviation|Mean
2659765|NCT01586364|Primary|Change From Baseline in Erythrocyte Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.|||(x10(12)/L)||Standard Deviation|Mean
2659565|NCT01587898|Secondary|Change From Baseline in Transferrin Saturation at Week 2 and Week 4|Transferrin saturation was measured as a percentage, and is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation was the pre-dose value on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (Day 1 Pre-dose), Week 2 and 4|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of transferrin saturation||Standard Deviation|Mean
2659566|NCT01587898|Secondary|Change From Baseline in Transferrin at Week 2 and Week 4|Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (Day 1 Pre-dose), Week 2 and 4|ITT population. Only those participants available at the specified time points were analyzed.|||Grams per litre (G/L)||Standard Deviation|Mean
2659567|NCT01587898|Secondary|Change From Baseline in Ferritin at Week 2 and Week 4|Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (Day 1 Pre-dose), Week 2 and 4|ITT Population. Only those participants available at the specified time points were analyzed.|||mcg/L||Standard Deviation|Mean
2659568|NCT01587898|Secondary|Change From Baseline in Hepcidin at Week 2 and Week 4|Blood samples for hepcidin were collected at Day 1 (pre-dose), Week 2 (approximately between 4 to 8 h) and Week 4 (pre-dose). Hepcidin is a regulator of iron metabolism. Baseline was the last pre-dose value on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. Where hepcidin values were missing because the value was below the quantification limit (BQL), the BQL value was imputed.|Baseline (Pre-dose on Day 1), Week 2 and 4|ITT Population. Only those participants available at the specified time points were analyzed.|||Microgram per Litre (mcg/L)||Standard Deviation|Mean
2659569|NCT01587898|Secondary|Number of Participants Who Reached Hgb Stopping Criteria|The Hgb stopping criteria was defined as reaching to value <8.0 g/dL, >=8.0 - <13.0 (>= 2g/dL absolute Hgb change over 1 week ) or >=13.0 g/dL. The number of participants who reached the Hgb stopping criteria of Hgb concentration were presented.|Up to Week 4|ITT Population.|||Participants|||Count of Participants
2659570|NCT01587898|Secondary|Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb|Percentage of participants achieving an increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb from baseline were reported. Entry into the study requires a target stable Hgb of 8.5-11.0 g/dL. A stable Hgb value was confirmed from three Hgb values taken during the screening period at Week -2, Week -1 and Day 1 (randomization). The average of these three values was used for Baseline Hgb.|Up to 4 weeks|ITT population.|||Percentage of participants|||Number
2659571|NCT01587898|Secondary|Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb|Number of participants achieving an increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb from baseline were reported. Entry into the study required a target stable Hgb of 8.5-11.0 g/dL. A stable Hgb value was confirmed from three Hgb values taken during the screening period at Week -2, Week -1 and Day 1 (randomization). The average of these three values was used for Baseline Hgb.|Up to 4 weeks|ITT Population.|||Participants|||Count of Participants
2659572|NCT01587898|Secondary|Model-Adjusted Maximum Hgb Changes Over 4 Weeks|Maximum Hgb change over 4 weeks was analyzed using an ANCOVA model with terms included for treatment and baseline Hgb value. Least square mean estimates and 95% CI for each treatment group were reported. Baseline was the average of Week -2 , Week -1 and Day 1 visits. The change from Baseline was calculated by subtracting the baseline value from the individual post-dose visit values.|Baseline (average of Week -2 , -1 and Day 1 visits) and 4 weeks|ITT population.|||g/dL||Standard Error|Least Squares Mean
2659573|NCT01587898|Primary|Modeled Hgb Change From Baseline Over 4 Weeks of Treatment|Modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model. The model included fixed effects for baseline Hgb, treatment and a treatment by day interaction. Random effects was fitted in the intercept and the slope over time. All data up until investigational product discontinuation was included for Hgb efficacy evaluable participants; where efficacy evaluable was defined as having a baseline and at least 2 on-treatment Hgb assessments. Baseline was the average of Week -2 , Week -1 and Day 1 visits. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.|Baseline (average of Week -2, -1 and Day 1) and Week 4|The ITT population comprised of all randomized participants who received at least one dose of study medication, and had a baseline and at least one corresponding on treatment laboratory assessment. Only those participants with data available at the indicated time points were analyzed.|||gram per decilitre (g/dL)||Standard Deviation|Mean
2659574|NCT01587885|Secondary|Percentage of Participants Affected By Heartburn Symptoms: End of Treatment Quality of Life Questionnaire|End of Treatment Quality of Life was based on a questionnaire regarding quality-of-life issues associated with heartburn, completed by participants at the end of treatment period 1 and the end of treatment period 2.|End of treatment period 1 and end of treatment period 2|Participants in the mITT population, consisting of all randomized participants who received study drug and who provided efficacy data for at least one of the study drugs for the variable and time point analyzed.|||percentage of partcipants|||Number
2659575|NCT01587885|Secondary|Number of Participants Preferring Each Treatment Overall: Final Subjective Questionnaire|Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 3 asked participants to compare the 2 treatments for their overall preference.|At end of study (approx. Study Day 40)|Participants in the ITT population, consisting of all participants who were randomized, took study medication at the beginning of treatment period 1, and provided data.|||participants|||Number
2659576|NCT01587885|Secondary|Number of Participants Preferring Each Treatment for Heartburn Relief: Final Subjective Questionnaire|Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 2 asked participants to compare the 2 treatments for Heartburn Relief.|At end of study (approx. Study Day 40)|Participants in the ITT population, consisting of all participants who were randomized, took study medication at the beginning of treatment period 1, and provided data.|||participants|||Number
2659761|NCT01586364|Primary|Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.|||(x10(9)/L)||Standard Deviation|Mean
2659577|NCT01587885|Secondary|Number of Participants Preferring Each Treatment for Heartburn Control: Final Subjective Questionnaire|Participants completed a Final Subjective Questionnaire for Treatment Preference. Question 1 asked participants to compare the 2 treatments for Heartburn Control.|At end of study (approx. Study Day 40)|Participants in the Intent-to-Treat (ITT) population, consisting of all participants who were randomized, took study medication at the beginning of treatment period 1, and provided data.|||participants|||Number
2659578|NCT01587885|Secondary|Percentage of Participants Experiencing Onset and Demonstrating Duration of Heartburn Relief Over Time|"Onset of heartburn relief was defined as a reduction of at least one grade from baseline in the severity of heartburn following start of treatment. Severity of heartburn was evaluated by the participant using the 4-point Likert Scale, which rated heartburn severity as follows:~Absent (0): Heartburn is not present.~Mild (1): Heartburn did not last long or was easily tolerated.~Moderate (2): Heartburn caused discomfort and interrupted usual activities.~Severe (3): Heartburn caused great interference with usual activities and may have been incapacitating."|Start of treatment until onset of heartburn relief, up to 72 hours|"Participants in the mITT population, consisting of all randomized participants who received study drug and who provided efficacy data for at least one of the study drugs for the variable and time point analyzed.~One participant completed the study but the participant's data was corrupted and therefore not included."|||percentage of participants|||Number
2659579|NCT01587885|Primary|Time-to-onset of Heartburn Relief|"Time-to-onset of heartburn relief was defined as earliest time following start of treatment that participant experienced a reduction of at least one grade from baseline in the severity of heartburn. Severity of heartburn was evaluated by the participant using the 4-point Likert Scale, which rated heartburn severity as follows:~Absent (0): Heartburn is not present.~Mild (1): Heartburn did not last long or was easily tolerated.~Moderate (2): Heartburn caused discomfort and interrupted usual activities.~Severe (3): Heartburn caused great interference with usual activities and may have been incapacitating."|Start of treatment until onset of heartburn relief, up to 24 hours|"Participants in the modified Intent-to-Treat (mITT) population, consisting of all randomized participants who received study drug and who provided efficacy data for at least one of the study drugs for the variable and time point analyzed.~One participant completed the study but the participant's data was corrupted and therefore not included."|||Minutes||Inter-Quartile Range|Median
2659580|NCT01587703|Primary|Number of Participants With Non-serious AEs and SAEs-Besylate Sub-study|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment|Median of 1.87 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659581|NCT01587703|Secondary|Volume of Distribution of GSK525762-Part 1 BID|Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.|pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4|PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Liters||Geometric Coefficient of Variation|Geometric Mean
2659582|NCT01587703|Secondary|Apparent Clearance of GSK525762-Part 1 BID|Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.|pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4|PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
2659583|NCT01587703|Secondary|Tmax for GSK525762-Part 1 BID|Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.|pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4|PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Hour||Full Range|Median
2659584|NCT01587703|Secondary|Lambda z for GSK525762-Part 1 BID|Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.|pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4|PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Per hour||Geometric Coefficient of Variation|Geometric Mean
2659585|NCT01587703|Secondary|Maximum Observed Concentration of GSK525762-Part 1 BID|Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.|pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4|PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Nanogram per milliter||Geometric Coefficient of Variation|Geometric Mean
2659586|NCT01587703|Secondary|AUC (0 to Inf), AUC (0 to 24) and AUC (0 to t) of GSK525762-Part 1 BID|Blood samples were collected at indicated time points post ante-meridiem (AM) and post-meridiem (PM) dose for pharmacokinetic analysis of GSK525762.|pre-dose,0.25,0.5,1,2,4,8,12 hours post-AM dose at Week1Day1 and Week3 Day 4; Week1 Day5(0.5, 3 hours post-AM dose); pre-dose, 0.25,0.5,1,2,4,8,12, 36 hours post-PM dose at Week1Day1 and Week3 Day4|PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Hours*nanogram per milliter||Geometric Coefficient of Variation|Geometric Mean
2659588|NCT01587703|Secondary|Apparent Clearance of GSK525762-Part 1 QD|Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.|pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4|PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Liter per hour||Geometric Coefficient of Variation|Geometric Mean
2659589|NCT01587703|Secondary|Tmax for GSK525762-Part 1 QD|Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.|pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4|PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Hours||Full Range|Median
2659590|NCT01587703|Secondary|Lambda z for GSK525762-Part 1 QD|Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.|pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4|PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Per hour||Geometric Coefficient of Variation|Geometric Mean
2659591|NCT01587703|Secondary|Maximum Observed Concentration for GSK525762-Part 1 QD|Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762.|pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4|PK Parameter Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles)|||Nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2659592|NCT01587703|Secondary|AUC (0 to t), AUC (0 to 24) and AUC (0 to Inf) of GSK525762-Part 1 QD|Blood samples were collected at the indicated time points for pharmacokinetic analysis of GSK525762. PK parameter population comprised of all participants in the PK Concentration Population (all participants in the All Treated Population for whom a blood sample for pharmacokinetics is obtained and analyzed) for whom a PK parameter has been obtained.|pre-dose,0.25,0.5,1,2,4,8,12,24 and 48 hours post-dose at Week1 Day1 and Week 3 Day 4|PK Parameter Population. Only those participants with data available at the specified time points were available (indicated by n=X in category titles)|||Hours*nanogram per milliliter||Geometric Coefficient of Variation|Geometric Mean
2659593|NCT01587703|Secondary|Overall Survival-Besylate Sub-study|Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.|Median of 1.87 months of drug exposure|All Treated Population. Data for Besylate sub-study participants were combined for analysis to provide useful interpretation of study data as pre-specified in RAP.|||Months||95% Confidence Interval|Median
2659594|NCT01587703|Secondary|Overall Survival-Part 2|Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.|Median of 1.41 months of drug exposure|All Treated Population|||Months||95% Confidence Interval|Median
2659595|NCT01587703|Secondary|Overall Survival-Part 1 BID|Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.|Median of 1.41 months of drug exposure|All Treated Population|||Months||95% Confidence Interval|Median
2659596|NCT01587703|Secondary|Overall Survival-Part 1 QD|Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.|Median of 1.38 months of drug exposure|All Treated Population|||Months||95% Confidence Interval|Median
2659597|NCT01587703|Secondary|Duration of Response-Besylate Sub-study|Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve a confirmed CR or PR. Duration of response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.|Median of 1.87 months of drug exposure|All Treated Population. Participants with incomplete response dates were excluded from the analysis.||||||
2659598|NCT01587703|Secondary|Duration of Response-Part 2|Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve a confirmed CR or PR. Duration of response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.|Median of 1.41 months of drug exposure|All Treated Population. Participants with incomplete response dates were excluded from the analysis.||||||
2659599|NCT01587703|Secondary|Duration of Response-Part 1 BID|Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve a confirmed CR or PR. Duration of response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.|Median of 1.41 months of drug exposure|All Treated Population. Participants with incomplete response dates were excluded from the analysis.||||||
2659600|NCT01587703|Secondary|Duration of Response-Part 1 QD|Duration of response is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause among participants who achieve a confirmed CR or PR. Duration of response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.|Median of 1.38 months of drug exposure|All Treated Population. Participants with incomplete response dates were excluded from the analysis.||||||
2659601|NCT01587703|Secondary|Time to Response-Besylate Sub-study|Time to response is defined, for participants with a confirmed CR or PR, as the time from first dose to the first documented evidence of CR or PR. Time to response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.|Median of 1.87 months of drug exposure|All Treated Population. Participants with incomplete response dates were excluded from the analysis.||||||
2659950|NCT01585441|Secondary|Change in Central Retinal Thickness in the Study Eye at the Safety Visit Compared to Baseline|Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT).|Final Study Visit||||μm|Participants|Standard Deviation|Mean
2659602|NCT01587703|Secondary|Time to Response-Part 2|Time to response is defined, for participants with a confirmed CR or PR, as the time from first dose to the first documented evidence of CR or PR. Time to response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.|Median of 1.41 months of drug exposure|All Treated Population. Participants with incomplete response dates were excluded from the analysis.||||||
2659603|NCT01587703|Secondary|Time to Response-Part 1 BID|Time to response is defined, for participants with a confirmed CR or PR, as the time from first dose to the first documented evidence of CR or PR. Time to response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.|Median of 1.41 months of drug exposure|All Treated Population. Participants with incomplete response dates were excluded from the analysis.||||||
2659604|NCT01587703|Secondary|Time to Response-Part 1 QD|Time to response is defined, for participants with a confirmed CR or PR, as the time from first dose to the first documented evidence of CR or PR. Time to response is not derived for participants with incomplete response dates. Confidence intervals were estimated using Brookmeyer Crowley method.|Median of 1.38 months of drug exposure|All Treated Population. Participants with incomplete response dates were excluded from the analysis.||||||
2659605|NCT01587703|Secondary|Progression Free Survival-Besylate Sub-study|Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and the date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.|Median of 1.87 months of drug exposure|All Treated Population. Data for Besylate sub-study participants were combined for analysis to provide useful interpretation of study data as pre-specified in RAP.|||Months||95% Confidence Interval|Median
2659606|NCT01587703|Secondary|Progression Free Survival-Part 2|Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and the date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.|Median of 1.41 months of drug exposure|All Treated Population|||Months||95% Confidence Interval|Median
2659607|NCT01587703|Secondary|Progression Free Survival-Part 1 BID|Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.|Median of 1.41 months of drug exposure|All Treated Population|||Months||95% Confidence Interval|Median
2659608|NCT01587703|Secondary|Progression Free Survival-Part 1 QD|Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.|Median of 1.38 months of drug exposure|All Treated Population|||Months||95% Confidence Interval|Median
2659609|NCT01587703|Secondary|Number of Participants With Increase in QTcF-Besylate Sub-study|ECG measurements were done using 12-lead ECG machine that automatically calculated the heart rate and measured PR, QRS, QT and QTcF intervals. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.|Median of 1.87 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659610|NCT01587703|Secondary|Number of Participants With Increase in QTcF-Part 2|ECG measurements were done using an automated 12-lead ECG machine. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.|Median of 1.41 months of drug exposure|All Treated Population. Only those participants with data available at the specified time point were analyzed.|||Participants|||Count of Participants
2659611|NCT01587703|Secondary|Number of Participants With Increase in QTcF-Part 1 BID|ECG measurements were done using an automated 12-lead ECG machine. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.|Median of 1.41 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659612|NCT01587703|Secondary|Number of Participants With Increase in QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)-Part 1 QD|Electrocardiogram (ECG) measurements were done using an automated 12-lead ECG machine. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.|Median of 1.38 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659613|NCT01587703|Primary|Time to Reach Cmax (Tmax) for GSK525762-Besylate Sub-study|Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points.|Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)|Besylate Sub-Study PK Parameter Population. Only those participants with data available at the specified time points were analyzed.|||Hours||Full Range|Median
2659614|NCT01587703|Primary|Apparent Terminal Phase Elimination Rate Constant (Lambda z) for GSK525762-Besylate Sub-study|Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points.|Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)|Besylate Sub-Study PK Parameter Population. Only those participants with data available at the specified time points were analyzed.|||Per hour||Geometric Coefficient of Variation|Geometric Mean
2668023|NCT01509677|Secondary|Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (IL-8 (pg/mL))||Baseline to 14 weeks||||pg/mL||Standard Error|Least Squares Mean
2659615|NCT01587703|Primary|Maximum Observed Concentration (Cmax) of GSK525762-Besylate Sub-study|Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points.|Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)|Besylate Sub-Study PK Parameter Population. Only those participants with data available at the specified time points were analyzed.|||Nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2659616|NCT01587703|Primary|Area Under the Concentration-time Curve (AUC) From Time Zero to 24 Hours(AUC[0 to 24]); AUC From Time 0 to Last Quantifiable Concentration (AUC [0 to t]) and AUC Extrapolated to Infinity (AUC[0 to Inf]) of GSK525762-Besylate Sub-study|Blood samples for pharmacokinetic analysis of GSK525762 were collected at the indicated time points. Besylate sub-study pharmacokinetic (PK) Parameter Population consisted of all participants in the PK Parameter Population who participated in the besylate substudy.|Week1 Day1, Day3 and Week2 Day1 (pre-dose,0.25,0.5,1,1.5,2,3,4,6,8,24,48 hours post-dose)|Besylate Sub-Study PK Parameter Population. Only those participants with data available at the specified time points were analyzed.|||Hours*nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2659617|NCT01587703|Primary|Number of Participants With PSA50 Response-Besylate Sub-study|PSA 50 Response rate is defined as the response rate that a PSA reduction from Baseline >=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA >=50% reduction is presented along with 95% confidence intervals.|Median of 1.87 months of drug exposure|All Treated Population|||Participants||95% Confidence Interval|Number
2659618|NCT01587703|Primary|Number of Participants With PSA50 Response-Part 2|PSA 50 response rate is defined as the response rate that a PSA reduction from Baseline >=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA >=50% reduction is presented along with 95% confidence intervals.|Median of 1.41 months of drug exposure|All Treated Population|||Participants||95% Confidence Interval|Number
2659619|NCT01587703|Primary|Number of Participants With PSA50 Response Rate-Part 1 BID|PSA 50 Response rate is defined as the response rate that a PSA reduction from Baseline >=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA >=50% reduction is presented along with 95% confidence intervals.|Median of 1.41 months of drug exposure|All Treated Population|||Participants||95% Confidence Interval|Number
2659620|NCT01587703|Primary|Number of Participants With Prostate Specific Antigen (PSA)50 Response-Part 1 QD|PSA 50 response rate is defined as the response rate that a PSA reduction from Baseline >=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA >=50% reduction is presented along with 95% confidence intervals.|Median of 1.38 months of drug exposure|All Treated Population|||Participants||95% Confidence Interval|Number
2659621|NCT01587703|Primary|Overall Response Rate-Besylate Sub-study|Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.|Median of 1.87 months of drug exposure|All Treated Population. Data for Besylate sub-study participants were combined for analysis to provide useful interpretation of study data as pre-specified in RAP.|||Percentage of participants||95% Confidence Interval|Number
2659622|NCT01587703|Primary|Overall Response Rate-Part 2|Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.|Median of 1.41 months of drug exposure|All Treated Population|||Percentage of participants||95% Confidence Interval|Number
2659623|NCT01587703|Primary|Overall Response Rate-Part 1 BID|Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.|Median of 1.41 months of drug exposure|All Treated Population|||Percentage of participants||95% Confidence Interval|Number
2659624|NCT01587703|Primary|Overall Response Rate-Part 1 QD|Overall response rate is defined as the percentage of participants who achieved a confirmed complete response (CR) or partial response (PR) from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST version (v) 1.1). CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeters (mm) in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.|Median of 1.38 months of drug exposure|All Treated Population|||Percentage of participants||95% Confidence Interval|Number
2659625|NCT01587703|Primary|Number of Participants With Changes in Temperature From Baseline-Besylate Sub-study|Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is <=35 degree Celsius and >=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.|Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659762|NCT01586364|Primary|Change From Baseline in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.|||fL||Standard Deviation|Mean
2659626|NCT01587703|Primary|Number of Participants With Changes in Temperature From Baseline-Part 2|Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is <=35 degree Celsius and >=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.|Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure|All Treated Population. Only those participants with data available at Baseline and the specified time points were analyzed.|||Participants|||Count of Participants
2659627|NCT01587703|Primary|Number of Participants With Changes in Temperature From Baseline-Part 1 BID|Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is <=35 degree Celsius and >=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.|Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659628|NCT01587703|Primary|Number of Participants With Changes in Temperature From Baseline-Part 1 QD|Temperature was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for temperature is <=35 degree Celsius and >=38 degree Celsius. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.|Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659629|NCT01587703|Primary|Number of Participants With Increase in Blood Pressure From Baseline-Besylate Sub-study|SBP and DBP were measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (>=160) and DBP: Grade 0 (<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.|Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659630|NCT01587703|Primary|Number of Participants With Changes in Blood Pressure From Baseline-Part 2|SBP and DBP were measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (>=160) and DBP: Grade 0 (<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.|Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure|All Treated Population. Only those participants with data available at Baseline and the specified time points were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2659631|NCT01587703|Primary|Number of Participants With Increase in Blood Pressure From Baseline-Part 1 BID|SBP and DBP were measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (>=160) and DBP: Grade 0 (<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented|Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure|All Treated Population. Only those participants with data available at Baseline and the specified time point were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2659632|NCT01587703|Primary|Number of Participants With Increase in Blood Pressure From Baseline-Part 1 QD|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (>=160) and DBP: Grade 0 (<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented|Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659633|NCT01587703|Primary|Number of Participants With Changes in Pulse Rate From Baseline-Besylate Sub-study|Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for pulse rate is <60 beats per minute and >100 beats per minute. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.|Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659634|NCT01587703|Primary|Number of Participants With Changes in Pulse Rate From Baseline-Part 2|"Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for pulse rate is <60 beats per minute and >100 beats per minute. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented. Participants were counted twice if the participant Decreased to <60 and Increased to >100 post-baseline."|Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure|All Treated Population. Only those participants with data available at Baseline and the specified time points were analyzed.|||Participants|||Count of Participants
2659635|NCT01587703|Primary|Number of Participants With Changes in Pulse Rate From Baseline-Part 1 BID|Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.|Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659636|NCT01587703|Primary|Number of Participants With Changes in Pulse Rate From Baseline-Part 1 QD|"Pulse rate was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. The clinical concern range for pulse rate is <60 beats per minute and >100 beats per minute. Participants were counted twice if the participant Decreased to <60 and Increased to >100 post-baseline. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented"|Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure|All Treated Population. Only those participants with data available at Baseline and the specified time point were analyzed.|||Participants|||Count of Participants
2659637|NCT01587703|Primary|Number of Participants With Maximum Urinalysis Change From Baseline-Besylate Sub-study|Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented.|Baseline (pre-dose Week1 Day1), Weeks 5,9,17,25 and disc/prog|All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2659638|NCT01587703|Primary|Number of Participants With Maximum Urinalysis Change From Baseline-Part 2|Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented.|Baseline (pre-dose Week1 Day1), Weeks 5,9,13,25,37, 49, 73, 85 and discharge/progression|All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2659639|NCT01587703|Primary|Number of Participants With Maximum Urinalysis Change From Baseline Data-Part 1 BID|Urine samples were collected for the analysis of following urine parameters: pH, glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented.|Baseline (pre-dose Week1 Day1) and Weeks 5,9,17 and discharge/progression|All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2659640|NCT01587703|Primary|Number of Participants With Maximum Urinalysis Change From Baseline-Part 1 QD|Urine samples were collected for the analysis of following urine parameters: potential of hydrogen (pH), glucose, protein, occult blood, ketones, specific gravity, erythrocytes and leukocytes. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Only parameters and time points with non-zero values for any increase have been presented.|Baseline (pre-dose Week1 Day1) and Weeks 5, 9, 17, 25, 33, 41, 49 and discharge/progression (disc/prog)|All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2659641|NCT01587703|Primary|Number of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-study|Blood samples were collected for the analysis of hematology parameters: aPTT, platelet count, RBC, WBC, INR, PT, Fib, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.|Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659642|NCT01587703|Primary|Number of Participants With Grade Change From Baseline in Hematology Data-Part 2|Blood samples were collected for the analysis of hematology parameters: aPTT, platelet count, RBC, WBC, INR, PT, Fib, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.|Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure|All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2659643|NCT01587703|Primary|Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 BID|Blood samples were collected for the analysis of hematology parameters: aPTT, platelet count, RBC, WBC, INR, PT, Fib, hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.|Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure|All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2659644|NCT01587703|Primary|Number of Participants With Grade Change From Baseline in Hematology Data-Part 1 QD|Blood samples were collected for the analysis of hematology parameters: activated partial thromboplastin time (aPTT), platelet count, red blood cell count (RBC), white blood cell count (WBC), prothrombin international normalized ratio (INR), prothrombin time (PT), fibrinogen (Fib), hemoglobin, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.|Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure|All Treated Population. Only those participants with data available at the specified time points were analyzed.|||Participants|||Count of Participants
2668024|NCT01509677|Secondary|Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (Alfa- 2-Macroglobulin (µg/mL))||Baseline to 14 weeks||||µg/mL||Standard Error|Least Squares Mean
2659645|NCT01587703|Primary|Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-study|Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented.|Baseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposure|All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2659646|NCT01587703|Primary|Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2|Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides (triglyc), troponin I and T, urate and urea. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post-Baseline is presented.|Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure|All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2659647|NCT01587703|Primary|Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BID|Blood samples were collected for the analysis of clinical chemistry parameters: glucose, albumin, ALP, ALT, amylase, AST, Dir bil, bilirubin, NT-BNP, calcium, cholesterol, CK, chloride, CO2, creatinine, GGT, HDL and LDL cholesterol, insulin, potassium, LDH, lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post-Baseline is presented.|Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposure|All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2659648|NCT01587703|Primary|Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QD|Blood samples were collected for the analysis of: glucose, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), amylase, aspartate aminotransferase (AST), direct bilirubin (Dir bil), bilirubin, N-Terminal proB-type natriuretic peptide (NT-BNP), calcium, cholesterol, creatine kinase (CK), chloride, carbon dioxide (CO2), creatinine, gamma glutamyl transferase (GGT), high and low density lipoprotein (HDL and LDL), insulin, potassium, lactate dehydrogenase (LDH), lipase, magnesium, protein, sodium, thyroxine, testosterone, triglycerides, troponin I and T, urate and urea. Grading was done according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death. Baseline is the most recent, non-missing value prior to or on first study treatment dose date. Data for worst case post-Baseline is presented.|Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure|All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).|||Participants|||Count of Participants
2659649|NCT01587703|Primary|Number of Participants Withdrawn Due to Toxicities-Besylate Sub-study|Number of participants withdrawn due to toxicities is presented.|Median of 1.87 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659650|NCT01587703|Primary|Number of Participants Withdrawn Due to Toxicities-Part 2|Number of participants withdrawn due to toxicities is presented.|Median of 1.41 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659651|NCT01587703|Primary|Number of Participants Withdrawn Due to Toxicities-Part 1 BID|Number of participants withdrawn due to toxicities is presented.|Median of 1.41 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659652|NCT01587703|Primary|Number of Participants Withdrawn Due to Toxicities-Part 1 QD|Number of participants withdrawn due to toxicities is presented.|Median of 1.38 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659653|NCT01587703|Primary|Number of Participants With Dose Reductions or Delays-Besylate Sub-study|The number of participants who had any dose reductions or delays is presented.|Median of 1.87 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659654|NCT01587703|Primary|Number of Participants With Dose Reductions or Delays-Part 2|The number of participants who had any dose reductions or delays is presented.|Median of 1.41 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659655|NCT01587703|Primary|Number of Participants With Dose Reductions or Delays-Part 1 BID|The number of participants who had any dose reductions or delays is presented.|Median of 1.41 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659656|NCT01587703|Primary|Number of Participants With Dose Reductions or Delays-Part 1 QD|The number of participants who had any dose reductions or delays is presented.|Median of 1.38 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659689|NCT01587040|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters|Biochemical parameters assessed were hyperglycemia, aspartate aminotransferase (ASAT) increased, alanine aminotransferase (ALAT) increased, hyperbilirubinemia, hypocalcemia, creatinine increased. Parameters were assessed as per the NCI-CTCAE v 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.|From Baseline up to 30 days after the last dose (maximum exposure: 1959 days)|"Analysis was performed on safety population. Here, number analyzed= participants with available data for specified category."|||Participants|||Count of Participants
2659657|NCT01587703|Primary|Number of Participants With AEs and SAEs-Part 2|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment.|Median of 1.41 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659658|NCT01587703|Primary|Number of Participants With AEs and SAEs-Part 1 BID|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment|Median of 1.41 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659659|NCT01587703|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD|An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment. All Treated Population comprised of all participants who received at least one dose of study treatment.|Median of 1.38 months of drug exposure|All Treated Population|||Participants|||Count of Participants
2659660|NCT01587651|Secondary|Percentage of Subjects With High On-treatment Platelet Reactivity|"Percentage of subjects with High on-treatment Platelet Reactivity (HPR) defined as a) >= 208 PRU and b) >= 230 PRU by the VerifyNow P2Y12 assay and c) >50% PRI by the VASP assay, 2, 4, 24, and 48 hours and 7 days after first randomized study treatment.~A poor response of the platelets to drug, called High Residual Platelet Reactivity (HRPR), has been incriminated to account for a recurrence of ischemic events"|2, 4, 24, 48 hours, 7 days after first randomized dose|Primary population|||percentage of subjects|||Number
2659661|NCT01587651|Secondary|PRU Percent Inhibition (Calculated)|"Analysis of Mean Calculated Percent Inhibition by time point~Calculated percent inhibition at time point t is defined as: 100 × (baseline PRU - PRUt)/baseline PRU where baseline PRU is the VerifyNow PRU value at pre-run-in baseline and PRUt is the VerifyNow PRU value at time t."|2, 4, 24, 48 hours, 7 days after first randomized dose|Primary population|||Percent Inhibition||Standard Error|Least Squares Mean
2659662|NCT01587651|Secondary|PRU Percent Inhibition (Device-reported)|"PRU VerifyNow P2Y12 assay device-reported percent inhibition 2, 4, 24, and 48 hours, and 7 days after first randomized study treatment~VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. The percent inhibition reported by VerifyNow device represents the percentage inhibition relative to maximal P2Y12-independent platelet aggregation achieved with the same sample in the presence of the iso-thrombin receptor activating peptide."|2, 4, 24, 48 hours, 7 days after first randomized dose|Primary population|||percent inhibition||Standard Error|Least Squares Mean
2659663|NCT01587651|Secondary|Platelet Reactivity Index|"Platelet Reactivity Index (PRI) by the Vasodilator-Stimulated Phosphoprotein(VASP) assay 2, 4, 24, 48 hours and 7 days after first randomized study treatment.~The VASP assay is an indirect, but relatively specific measure of inhibition of P2Y12-induced platelet activation. The assay quantifies the level of phosphorylation of the intracellular protein VASP, which undergoes phosphorylation when platelet P2Y12 receptors are blocked. The level of VASP phosphorylation, expressed as the PRI, represents the percentage inhibition relative to an assay baseline/maximal P2Y12-independent platelet aggregation."|2, 4, 24, 48 hours, 7 days after first randomized dose|Primary Population|||percentage PRI||Standard Error|Least Squares Mean
2659664|NCT01587651|Secondary|P2Y12 Reaction Units|P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay measured at 2, 4, 24, 48 hours after first randomized study treatment|2, 4, 24, 48 hours after first randomized dose|Primary Population|||PRU||Standard Error|Least Squares Mean
2659665|NCT01587651|Primary|P2Y12 Reaction Units|P2Y12 Reaction Units (PRU) measured by VerifyNow P2Y12 assay VerifyNow P2Y12 assay, developed by Accumetrics, Inc. (San Diego, CA, USA), has been approved by the FDA to assess clopidogrel response using whole blood in a point-of-care testing fashion. Platelet aggregation with this system is defined by PRU, with a higher PRU indicative of greater platelet aggregation, and a lower PRU indicative of inhibition.|7 days after first randomized dose|Primary Population includes all subjects who received at least 1 dose of randomized study drug and have valid PRU data at both randomization visit pre-dosing and end-of-treatment visit. A subject is considered to have valid PRU data for primary PD analyses if he/she does not have certain protocol deviations listed in Statistical Analysis Plan.|||PRU (P2Y12 Reaction Units)||Standard Error|Least Squares Mean
2659704|NCT01586910|Secondary|Percentage of Participants With Early Safety Endpoint|Percentage of participants with VARC II early safety composite at 30 days|30 Days|Participant Population= Consisted of all randomized subjects with an attempted implant procedure.|||percentage of participants|||Number
2659763|NCT01586364|Primary|Change From Baseline in Hematocrit and Red Blood Cell (RBC) Distribution Width at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.|||percent change||Standard Deviation|Mean
2659666|NCT01587274|Primary|Change in Functional Disability as Measured by the Roland Morris Disability Questionnaire|"The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a yes or no. The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score."|Baseline and one week after discharge from emergency department|Multiple imputation used to account for participants lost to follow-up|||units on a scale||Inter-Quartile Range|Median
2659667|NCT01587118|Secondary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS)|BPRS is the clinician rating of psychiatric symptoms; higher score indicates higher severity; 18-items scored 1-7; highest score 126. Overall JE and Gorham DR. The Brief Psychiatric Rating Scale (BPRS): recent developments in ascertainment and scaling. Psychopharmacol Bulletin 1993; 24:97-99.|Baseline, week 4, 8, 12|Open label treatment, all participants included.Overall change in values from baseline to week 12, including weeks 4 and 8, using a simple one-way analysis of variance; because the sample size was small, p-values for the paired t-test and one-way results were recalculated using the signed rank test and Kruskal Wallis procedure, respectively|||units on a scale||Standard Deviation|Mean
2659668|NCT01587118|Primary|Change From Baseline in Clinical Administered PTSD Scale (CAPS) Total|CAPS is the clinician rating of posttraumatic stress disorder (PTSD) symptoms; higher scores indicate higher severity of PTSD; 17-item score range 0 to 136. Blake DD, Weathers FW, Nagy LM, et al. The development of a Clinician-Administered PTSD Scale. J Trauma Stress 1995; 8:75-90.|baseline, week 4, 8, and 12|Open label treatment, all participants included.Overall change in values from baseline to week 12, including weeks 4 and 8, using a simple one-way analysis of variance; because the sample size was small, p-values for the paired t-test and one-way results were recalculated using the signed rank test and Kruskal Wallis procedure, respectively|||units on a scale||Standard Deviation|Mean
2659669|NCT01587105|Secondary|Physician Satisfaction|Primary care provider (PCP)'s satisfaction with the care coordination program was measured on a scale of 0-100, where the higher number indicates more satisfaction. This variable was collected at baseline and 12-months but was dropped from the 18 month follow-up as previous analysis suggested it was not relevant to the stated objective.|Baseline, 12 Months, 18 months||||units on a scale||Standard Deviation|Mean
2659670|NCT01587105|Primary|Hospital Days Per Child|Number of days each participant stayed in the hospital; assessed from hospital administrative discharge data|Baseline, 12-Month, 18-Month||||days||95% Confidence Interval|Mean
2659671|NCT01587105|Primary|Inpatient Admissions Per Child||Baseline, 12 month, 18 month||||admissions per child||95% Confidence Interval|Mean
2659672|NCT01587105|Primary|ED Visits Per Child||Baseline, 12-month, 18-month||||ED visits||95% Confidence Interval|Mean
2659673|NCT01587105|Primary|Health Care Quality Ranking|For Healthcare Quality Rating, the construct is Parent Satisfaction. Parents were asked to rate the quality of the health care their child received. Overall range is 0-100. Higher values equal a better outcome or more satisfaction. Sub scales are not combined. The scale is considered continuous.|Baseline, 12-months, 18-months||||units on a scale||95% Confidence Interval|Mean
2659674|NCT01587105|Primary|Cost of Care|The investigators will examine whether the children in the CCM group experience decreased annual costs of care.|Baseline, 12 month, 18 month||||US Dollars||95% Confidence Interval|Mean
2659675|NCT01587079|Secondary|Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7|Change from baseline in mean evening post-dose daily peak flow readings (12 Hours post-dose for Spiriva)|Day 7|MITT|||L/min||95% Confidence Interval|Least Squares Mean
2659676|NCT01587079|Secondary|Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7|Change from baseline in mean evening pre-dose daily peak flow readings (BID treatments only)|Day 7|MITT|||L/min||95% Confidence Interval|Least Squares Mean
2659677|NCT01587079|Secondary|Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7|Change from baseline in mean morning post-dose daily peak flow readings on|Day 7|MITT|||L/min||95% Confidence Interval|Least Squares Mean
2659678|NCT01587079|Secondary|Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7|Change from baseline in mean morning pre-dose daily peak flow readings|Day 7|MITT|||L/min||95% Confidence Interval|Least Squares Mean
2659679|NCT01587079|Secondary|Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7|Change from baseline at evening 12-hour post-dose trough FEV1|Day 7|MITT|||Millliters||95% Confidence Interval|Least Squares Mean
2659680|NCT01587079|Secondary|Peak Change From Baseline IC on Day 7|Peak change from baseline IC|Day 7|MITT|||Millliters||95% Confidence Interval|Least Squares Mean
2659681|NCT01587079|Secondary|Change From Baseline in Morning Pre-dose Trough IC on Day 7|Change from baseline in morning pre-dose trough IC|Day 7|MITT|||Millliters||95% Confidence Interval|Least Squares Mean
2659682|NCT01587079|Secondary|Peak Change From Baseline in FEV1 on Day 7|Peak change from baseline in FEV1 Day 7|Day 7|MITT|||Millliters||95% Confidence Interval|Least Squares Mean
2659683|NCT01587079|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7|Change from baseline in morning pre-dose trough FEV1|Day 7|MITT|||Milliliters||95% Confidence Interval|Least Squares Mean
2659684|NCT01587079|Secondary|Peak Change From Baseline in Inspiratory Capacity on Day 1|Peak change from baseline in Inspiratory Capacity|Day 1|MITT|||Milliliters||95% Confidence Interval|Least Squares Mean
2659685|NCT01587079|Secondary|Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1|Proportion of subjects achieving >=12% improvement in FEV1|Day 1|MITT|||Percentage|||Number
2659686|NCT01587079|Secondary|Time to Onset of Action (>10% Improvement in FEV1) on Day 1|Time to onset of action (>10% improvement in FEV1)|Day 1|MITT|||Percentage|||Number
2659687|NCT01587079|Secondary|Peak Change From Baseline in FEV1 on Treatment Day 1|Peak change from Baseline in FEV1 on Treatment|Day 1|MITT|||Milliliters||95% Confidence Interval|Least Squares Mean
2659688|NCT01587079|Primary|FEV1 AUC 0-12 on Day 7|FEV1 AUC 0-12|Day 7|MITT|||Liters||95% Confidence Interval|Least Squares Mean
2659764|NCT01586364|Primary|Change From Baseline in Hemoglobin Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.|||g/dL||Standard Deviation|Mean
2659690|NCT01587040|Primary|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters|Hematological parameters assessed were anemia, neutropenia and thrombocytopenia. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.|From Baseline up to 30 days after the last dose (maximum exposure: 1959 days)|"Analysis was performed on safety population. Here, Overall number of participants analyzed = participants with available data for this outcome measure."|||Participants|||Count of Participants
2659691|NCT01587040|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. Serious adverse event (SAE): any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial/prolonged in-patient hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAEs: AEs that developed/worsened/became serious during on-treatment period (time from IMP until 30 days after last dose of any IMP). Any TEAE included participants with both SAE & non-SAEs. TEAE included participants with any treatment-emergent SAE (TESAE). TEAEs that led to death, dose reduction and/or delay, discontinuation & AEs related to treatment were reported. Grades (3=severe, 4=life-threatening/disabling) represents severity of AEs.|From Baseline up to 30 days after the last dose (maximum exposure: 1959 days)|Analysis was performed on safety population that included all participants who took at least 1 dose of study drug during the study.|||Participants|||Count of Participants
2659692|NCT01587027|Primary|Adverse Events.|Adverse event data was evaluated for incidence and severity for 6 days.|6 days.|All enrolled participants were analyzed for adverse events.|||Events|||Number
2659693|NCT01587014|Secondary|Determine Research Subject's Baseline Temperature.|Using intermittent temperature data obtained with Prima-Temp temperature patch and wireless transmission to a receiver box and PC, researchers will compare research subject's baseline temperature with temperatures taken in the ICU in the normal course of care.|0-14 days||||data unavailable|||Number
2659694|NCT01587014|Primary|Total Number of Adverse Events Experienced by Participants Between Day 0 and Day 14 After Receiving the Prima-Temp Temparature Patch|The nursing staff will complete a thermometer skin site assessment daily. If the patch is removed or dislodged prior to study day 7 and 14 data points for any reason other than temporary transfer from the floor for a medical study, the nursing staff will be asked to complete an additional comfort skin site assessment. The area evaluated by the nurse will include skin in contact with both the Covidien/Kendall Lifetrace® belt and the thermometer patch.|0-14 days||||Adverse event|||Number
2659695|NCT01587001|Secondary|Bronchoalveolar Lavage (BAL) Cell Glutathione (GSH) Levels|We measured changes at baseline and at 8 weeks in BAL whole cell total GSH levels and cellular 8-OHdG before and after treatment with NAC/placebo.|8 weeks of anti-oxidant therapy||||nmol/mg protein||Standard Deviation|Mean
2659696|NCT01587001|Primary|Bronchoalveolar Lavage (BAL) and Peripheral Blood Mononuclear Cells (PBMC) TNF-α Levels|Baseline peripheral blood mononuclear cells and bronchoalveolar lavage (BAL) lymphocyte percentages and lipopolysaccharide (LPS) stimulated tumor necrosis factor-α levels (pg/ml)|8 weeks of anti-oxidant therapy||||pg/ml||Standard Deviation|Mean
2659697|NCT01586975|Primary|PFA1|"Platelet Function Analysis (PFA) lab results: PFA was performed using the PFA 100 device (Dade-Behring), which uses a higher sheer stress flow cytometry paradigm to measure the time in seconds to closing of an aperture. Normal is defined as <172 seconds."|3-6 months (Collected once between regulalary scheduled follow-up visit between 3-6 months)||||seconds||Standard Error|Mean
2659698|NCT01586962|Secondary|Safety and Tolerability of the Syrup|Number of participants with adverse events.|1 hour||||Participants|||Number
2659699|NCT01586962|Secondary|Subject Acceptability of the Syrup|"How do you like the warming sensation you have experienced for this product?~Possible responses are :~Like extremely Like very much Like moderately Like slightly Neither like nor dislike Dislike slightly Dislike moderately Dislike very much Dislike extremely"|1 hour||||Participants|||Number
2659700|NCT01586962|Primary|Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Pseudoephedrine 30 mg Per 30 ml Syrup|Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0 = no warming sensation and 100 = strongest possible warming sensation|1 minute||||mm||Standard Deviation|Mean
2659701|NCT01586910|Secondary|Resheath and Recapture Success (Evolut R Only)|The Evolut™ R system provides operators with the ability to resheath or recapture the valve before it is completely deployed in the event of initial suboptimal positioning. Successful resheath was defined as successfully retrieving a portion of the valve into the capsule of the delivery catheter, and successful recapture was defined as successfully recapturing the entirety of the valve into the capsule of the delivery catheter.|Procedure|Participant Population= Consisted of all subjects in whom the resheath or recapture feature of the Evolut R system was attempted|||percentage of attempts|attempts||Number
2659702|NCT01586910|Secondary|Percentage of Participants With Time-Related Safety|The VARC II time-related valve safety composite was defined as the rate of valve-related dysfunction (mean aortic valve gradient ≥ 20 mm Hg, EOA ≤ 0.9-1.1 cm2 depending on body surface area and/or DVI <0.35, AND/ OR moderate or severe prosthetic valve regurgitation), aortic valve reintervention, prosthetic valve endocarditis, prosthetic valve thrombosis, thromboembolic events, and VARC II bleeding events.|30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is available.|Participant Population= Consisted of all randomized subjects with an attempted implant procedure.|||percentage of participants|||Number
2659703|NCT01586910|Secondary|Percentage of Participants With Clinical Efficacy (After 30 Days)|Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, all strokes (disabling and non-disabling), hospitalization for valve-related symptoms or worsening congestive heart failure, NYHA III or IV, and valve-related dysfunction.|6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete|Participant Population= Consisted of all randomized subjects with an attempted implant procedure.|||percentage of participants|||Number
2668025|NCT01509677|Secondary|Change From V1 to V5 in Differential Cell Count in Induced Sputum(10^6 Lymphocytes)/mL)||Baseline to 14 weeks||||10^6 lymphocytes)/mL||Standard Error|Least Squares Mean
2659705|NCT01586910|Secondary|Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only)|"Prosthetic Valve Dysfunction (PVD) was defined according to Valve Academic Research Consortium (VARC) II using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total aortic regurgitation (AR) reported as moderate or severe was considered~PVD defined as:~Mean aortic valve gradient ≥20 mmHg AND ((EOA ≤0.9 cm2 if BSA <1.6 or ≤1.1 cm2 if BSA ≥1.6) OR DVI <0. 35 m/s) OR~moderate or severe total AR"|6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.|Participant Population= Consisted of all subjects with a valve implanted|||percentage of participants|||Number
2659706|NCT01586910|Secondary|Procedural Success (Medtronic CoreValve® System Subjects Only)|Defined by device success and absence of in-hospital major adverse cardiovascular and cerebrovascular events (MACCE)|Number of days from admission to discharge (expected average of 7 days)|Participant Population= Consisted of all randomized subjects with a TAVR index procedure who were evaluable for procedural success.|||percentage of participants|||Number
2659707|NCT01586910|Secondary|Device Success (Medtronic CoreValve® System Subjects Only)|"Absence of procedural mortality~Correct positioning of a single prosthetic heart valve into the proper anatomical location~Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation)"|Number of days from admission to discharge (expected average of 7 days)|Participant Population =Consisted of all randomized subjects with a TAVR index procedure who were evaluable for device success.|||percentage of participants|||Number
2659708|NCT01586910|Secondary|Presence of Atrial Fibrillation||post-procedure, discharge, 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.|Participant Population= Consisted of all randomized subjects with an attempted implant procedure.|||percentage of participants|||Number
2659709|NCT01586910|Secondary|Length of Index Procedure Hospital Stay||Number of days from admission to discharge (expected average of 7 days)|Participant Population= Consisted of all randomized subjects with an index procedure|||days||Standard Deviation|Mean
2659710|NCT01586910|Secondary|Index Procedure Related Major Adverse Events (MAEs)|Index procedure related MAEs were defined as events occurring during, or as a direct result of, the index procedure.|Procedure through 30 day visit|Participant Population= Consisted of all randomized subjects with an index procedure|||percentage of participants|||Number
2659711|NCT01586910|Secondary|Peri-procedural Neurological Injury|Neurological injury (stroke, TIA, or encephalopathy)|discharge or 7 days post index procedure (whichever occurred first)|Participant Population= Consisted of all randomized subjects with an index procedure|||percentage of participants|||Number
2659712|NCT01586910|Secondary|Percentage of Participants With Stroke and TIAs|Strokes (of any severity) and Transient Ischemic Attacks (TIAs)|30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.|Participant Population= Consisted of all randomized subjects with an attempted implant procedure.|||percentage of participants|||Number
2659713|NCT01586910|Secondary|Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths||30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete|Participant Population= Consisted of all randomized subjects with an attempted implant procedure.|||percentage of participants|||Number
2659714|NCT01586910|Secondary|Percentage of Participants With Aortic Valve Disease Related Hospitalizations||30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.|Participant Population= Consisted of all randomized subjects with an attempted implant procedure.|||percentage of particpants|||Number
2659715|NCT01586910|Secondary|Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance|"Using the following measure:~- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)"|discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete|Participant Population= Consisted of all randomized subjects with a valve implanted|||Percentage of participants|||Number
2659716|NCT01586910|Secondary|Effective Orifice Area as an Assessment of Prosthetic Valve Performance|"Using the following measure:~-Effective Orifice Area (cm^2)"|discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete|Participant Population= Consisted of all randomized subjects with a valve implanted|||cm^2||Standard Deviation|Mean
2659717|NCT01586910|Secondary|Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance|"Using the following measure:~-Transvalvular mean gradient"|discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete|Participant Population= Consisted of all randomized subjects with a valve implanted|||mmHg||Standard Deviation|Mean
2659718|NCT01586910|Secondary|Quality of Life (QoL) Change From Baseline|"QoL summary score change from baseline using the following measures:~Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.~36 Item Short Form Health Survey (SF-36): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.~European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state."|Baseline, 30 days, 3 months, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.|Participant Population= Consisted of all randomized subjects with an attempted implant procedure.|||units on a scale||Standard Deviation|Mean
2659719|NCT01586910|Secondary|Ratio of Days Alive Out of Hospital Versus Total Days Alive||12 and 24 months|Participant Population= Consisted of all randomized subjects with an attempted implant procedure.|||ratio||Standard Deviation|Mean
2659720|NCT01586910|Secondary|Change in Distance Walked During 6-minute Walk Test (6MWT)|Change in distance walked during 6MWT from baseline|From baseline to 30 days, baseline to 12 months, and baseline to 24 months|Participant Population= Consisted of all randomized subjects with an attempted implant procedure.|||meters||Standard Deviation|Mean
2659756|NCT01586364|Primary|Change From Baseline in Albumin and Total Protein Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.|||g/dL||Standard Deviation|Mean
2659721|NCT01586910|Secondary|Change in NYHA Class From Baseline|"Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement.~New York Heart Association (NYHA) Classification:~Class I: Subjects with cardiac disease but without resulting limitations of physical activity.~Class I: Subjects with cardiac disease resulting in slight limitation of physical activity.~Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.~Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort."|Baseline to 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.|Participant Population= Consisted of all randomized subjects with an attempted implant procedure.|||units on a scale||Standard Deviation|Mean
2659722|NCT01586910|Secondary|Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation||30 day, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.|Participant Population= Consisted of all randomized subjects with an attempted implant procedure.|||percentage of participants|||Number
2659723|NCT01586910|Secondary|Percentage of Participants With Major Adverse Events (MAE)|Major Adverse Events (MAE) include all death, MI, all stroke, reintervention, cardiac perforation, cardiac tamponade, cardiogenic shock, valve malpositioning, prosthetic valve dysfunction, acute kidney injury, major vascular complication, life threatening or disabling bleed, major bleed, and valve endocarditis.|30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.|Participant Population= Consisted of all randomized subjects with an attempted implant procedure.|||percentage of participants|||Number
2659724|NCT01586910|Secondary|Percentage of Participants With Individual MACCE Components|"MACCE is defined as a composite of:~All-cause death~Myocardial infarction (MI)~All stroke, and~Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.|Participant Population= Consisted of all randomized subjects with an attempted implant procedure.|||percentage of participants|||Number
2659725|NCT01586910|Secondary|Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)|"MACCE is defined as a composite of:~All-cause death~Myocardial infarction (MI)~All stroke, and~Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.|Participant Population= Consisted of all randomized subjects with an attempted implant procedure.|||percentage of participants|||Number
2659726|NCT01586910|Primary|All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability|"All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths.~Disabling Stroke: a modified rankin (mRS) score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-strike baseline."|24 months|Participant Population= Consisted of all randomized subjects with an attempted implant procedure.|||Percentage of Participants||95% Confidence Interval|Median
2659727|NCT01586897|Primary|Medication Safety Monitoring - ACE/ARB, Thiazide|Percentage of laboratory tests (potassium for thiazides, renal/potassium for ACE/ARBs that have been measured within 4-weeks following prescription. Treatment guidelines for prescription of ACE/ARBs recommend renal/potassium testing and potassium testing for prescription of thiazides. We chose 4-weeks following the prescription to represent successful safety monitoring.|Within 4 weeks following prescription|Patients prescribed ACE/ARB, thiazide|||percentage of tests within 4 weeks|||Number
2659728|NCT01586897|Primary|Medication Safety Monitoring - Metformin|Percentage of renal function laboratory tests that have been measured within 4-weeks following prescription. Treatment guidelines for prescription of metformin recommend renal function testing. We chose 4- weeks following the prescription to represent successful safety monitoring.|Within 4 weeks following prescription|Patients prescribed metformin|||percentage of tests within 4 weeks|||Number
2659729|NCT01586897|Primary|Medication Safety Monitoring - Statins|Percentage of laboratory tests (liver function tests after a new statin prescription or a change in statin dose) that have been measured within 4 weeks following prescription. Treatment guidelines for prescription of statins recommend follow-up liver function testing. We chose 4-weeks following the prescription to represent successful safety monitoring.|Within 4 weeks following prescription|Patients prescribed statins|||percentage of tests within 4 weeks|||Number
2659730|NCT01586897|Primary|Primary Effectiveness Outcome - A1c|Percentage of follow-up time (from initial prescription to final laboratory result available during the 18-month study period) that a patient is at or below risk factor goal for HbA1c(HbA1c ≤ 7.0%).|1 year|Patients prescribed oral medications for diabetes control during the study period|||percentage of time spent at goal||Standard Deviation|Mean
2659731|NCT01586897|Primary|Primary Effectiveness Outcome - LDL|Percentage of follow-up time (from initial prescription to final laboratory result available during the 18-month study period) that a patient is at or below risk factor goal for LDL(LDL-cholesterol ≤ 130 mg/dL for patients without cardiovascular risk and ≤ 100 mg/dl for patients with cardiovascular risk).|1 year|Patients prescribed statins during the study period|||percentage of time spent at goal||Standard Deviation|Mean
2659732|NCT01586819|Primary|Change From Pre- to Post-treatment Scores of Chemical Peel if Botox A is Added as Pre-treatment|The primary objective of this study is to determine if there is a significant difference between the change from pre- to post-treatment scores on the facial wrinkle severity scale between the chemical peel control group and the chemical peel plus Botox A treatment group. The primary dependent variable is the four-point Facial Wrinkle Severity Scale (FWSS): Grade 0 = no wrinkles; Grade 1 = mild wrinkles; Grade 2 = moderate wrinkles; and Grade 3 = severe wrinkles.|Baseline and 12 weeks|Twenty-six female subjects ages 30 to 75 years old were enrolled in this study.|||Units on a wrinkle severity scale||Inter-Quartile Range|Median
2659757|NCT01586364|Primary|Change From Baseline in MCV and MPV at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.|||fL||Standard Deviation|Mean
2659758|NCT01586364|Primary|Change From Baseline in Hematocrit and RBC Distribution Width at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.|||percent change||Standard Deviation|Mean
2659733|NCT01586819|Primary|Posttreament Results of Chemical Peel if Botox A is Added as Pre-treatment|The primary objective of this study is to determine if pre-treating the orbicularis oculi muscles with botulinum toxin A improves the results of medium depth chemical peels when treating lateral canthal rhytides. The primary dependent variable is the four-point Facial Wrinkle Severity Scale (FWSS): Grade 0 = no wrinkles; Grade 1 = mild wrinkles; Grade 2 = moderate wrinkles; and Grade 3 = severe wrinkles.|Baseline and 12 weeks|Twenty-six female subjects ages 30 to 75 years old were enrolled in this study.|||Units on a wrinkle severity scale||Inter-Quartile Range|Median
2659734|NCT01586806|Secondary|Opioid-Related Side Effects (Drowsiness)|Data collector will administer the Opioid-Related Distress Scale (OR-SDS) to determine if patients experience any opioid-related side effects (i.e. drowsiness). The OR-SDS score is on a scale of 0 to 4, with a higher number representing more severe symptoms.|Up to 2 days following surgery||||units on a scale||Inter-Quartile Range|Median
2659735|NCT01586806|Secondary|Postoperative Morphine Consumption|Data collector will record how many opioids (i.e. Percocet, Vicodin) the patient has used since discharge.|Up to 2 days following surgery||||milligrams||Inter-Quartile Range|Median
2659736|NCT01586806|Secondary|Patient Satisfaction|Patients will be asked to rate satisfaction on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied);|Up to 2 days following surgery||||units on a scale||Inter-Quartile Range|Median
2659737|NCT01586806|Secondary|NRS (Numerical Rating Scale) Pain Scores|Patients will be asked to rate, on a scale of 0-10, their pain while at rest. 0 indicates no pain, and 10 indicates the worst pain imaginable.|Postoperative day 1||||units on a scale||Inter-Quartile Range|Median
2659738|NCT01586806|Primary|Patient-perceived Duration of Analgesia|After discharge, patients will be called and given instructions to help determine length of time of analgesia in the saphenous nerve distribution.|Up to 2 days following surgery||||hours||95% Confidence Interval|Median
2659739|NCT01586364|Primary|Change From Baseline in Testosterone Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.|||ng/dL||Standard Deviation|Mean
2659740|NCT01586364|Primary|Change From Baseline in SHBG Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.|||nmol/L||Standard Deviation|Mean
2659741|NCT01586364|Primary|Change From Baseline in FSH and LH Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.|||IU/L||Standard Deviation|Mean
2659742|NCT01586364|Primary|Change From Baseline in E2 Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 196 out of 301 subjects were analyzed.|||pg/mL||Standard Deviation|Mean
2659743|NCT01586364|Primary|Change From Baseline in Testosterone Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.|||ng/dL||Standard Deviation|Mean
2659744|NCT01586364|Primary|Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.|||nmol/L||Standard Deviation|Mean
2659745|NCT01586364|Primary|Change From Baseline in Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.|||IU/L||Standard Deviation|Mean
2659746|NCT01586364|Primary|Change From Baseline in Estradiol (E2) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.|||pg/mL||Standard Deviation|Mean
2659747|NCT01586364|Primary|Change From Baseline in Specific Gravity of Urine at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 195 out of 301 subjects were analyzed.|||units||Standard Deviation|Mean
2659748|NCT01586364|Primary|Change From Baseline in pH of Urine at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 195 out of 301 subjects were analyzed.|||pH||Standard Deviation|Mean
2659749|NCT01586364|Primary|Change From Baseline in Specific Gravity of Urine at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 239 out of 301 subjects were analyzed.|||units||Standard Deviation|Mean
2659750|NCT01586364|Primary|Change From Baseline in pH of Urine at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 239 out of 301 subjects were analyzed.|||pH||Standard Deviation|Mean
2659751|NCT01586364|Primary|Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and BUN Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.|||mg/dL||Standard Deviation|Mean
2659752|NCT01586364|Primary|Change From Baseline in ALT, AST and CK Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.|||U/L||Standard Deviation|Mean
2659753|NCT01586364|Primary|Change From Baseline in Albumin and Total Protein Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 197 out of 301 subjects were analyzed.|||g/dL||Standard Deviation|Mean
2659754|NCT01586364|Primary|Change From Baseline in Bilirubin, Creatinine, Glucose, Uric Acid and Blood Urea Nitrogen (BUN) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.|||mg/dL||Standard Deviation|Mean
2659755|NCT01586364|Primary|Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase (CK) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.|||U/L||Standard Deviation|Mean
2659766|NCT01586364|Primary|Change From Baseline in Leukocyte, Lymphocyte, Monocyte and Platelet Count Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 240 out of 301 subjects were analyzed.|||(x10(9)/L)||Standard Deviation|Mean
2659767|NCT01586364|Primary|Change From Baseline in Fibrinogen (Plasma) Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.|||mg/dL||Standard Deviation|Mean
2659768|NCT01586364|Primary|Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.|||s||Standard Deviation|Mean
2659769|NCT01586364|Primary|Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 194 out of 301 subjects were analyzed.|||percent change||Standard Deviation|Mean
2659770|NCT01586364|Primary|Change From Baseline in Fibrinogen (Plasma) Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.|||mg/dL||Standard Deviation|Mean
2659771|NCT01586364|Primary|Change From Baseline in Activated Partial Thromboplastin Time (Plasma) at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.|||s||Standard Deviation|Mean
2659772|NCT01586364|Primary|Change From Baseline in Coagulation Parameters (Antithrombin Antigen, Protein C Antigen, Protein S Antigen) at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 242 out of 301 subjects were analyzed.|||percent change||Standard Deviation|Mean
2659773|NCT01586364|Primary|Assessment of Breast Palpation at Visit 3|Breast palpation was used to assess breast abnormalities.|Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.|||Participants|||Number
2659774|NCT01586364|Primary|Assessment of Breast Palpation at Visit 2|Breast palpation was used to assess breast abnormalities.|Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.|||Participants|||Number
2659775|NCT01586364|Primary|Assessment of Cervical Pap Smear Samples (if Cervix is Intact)|Cervical Pap smear samples are used to evaluate: atypical squamous cells of undetermined significance (ASC-US), squamous intraepithelial lesions (SILs), intraepithelial lesions or malignancy, and reactive endocervical cells and/or metaplastic cells.|Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 16 out of 301 subjects were analyzed.|||Participants|||Number
2659776|NCT01586364|Primary|Change From Baseline in Visual Evaluation of Vagina at Visit 3|Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)|Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 198 out of 301 subjects were analyzed.|||units on a scale||Standard Deviation|Mean
2659777|NCT01586364|Primary|Change From Baseline in Visual Evaluation of Vagina at Visit 2|Each of the categories in the table was assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe)|Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 243 out of 301 subjects were analyzed.|||units on a scale||Standard Deviation|Mean
2659778|NCT01586364|Primary|Change From Baseline in BMI at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.|||kg/m^2||Standard Deviation|Mean
2659779|NCT01586364|Primary|Change From Baseline in Weight at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.|||kg||Standard Deviation|Mean
2659780|NCT01586364|Primary|Change From Baseline in Pulse Rate at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.|||bpm||Standard Deviation|Mean
2659781|NCT01586364|Primary|Change From Baseline in Blood Pressure at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, at week 52, 199 out of 301 subjects were analyzed.|||mmHg||Standard Deviation|Mean
2659782|NCT01586364|Primary|Change From Baseline in Body Mass Index (BMI) at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.|||kg/m^2||Standard Deviation|Mean
2659783|NCT01586364|Primary|Change From Baseline in Weight at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.|||kg||Standard Deviation|Mean
2659784|NCT01586364|Primary|Change From Baseline in Pulse Rate at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.|||bpm||Standard Deviation|Mean
2659785|NCT01586364|Primary|Change From Baseline in Blood Pressure at Visit 2|Systolic blood pressure (SBP), diastolic blood pressure (DBP)|Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, at week 26, 244 out of 301 subjects were analyzed.|||mmHg||Standard Deviation|Mean
2659786|NCT01586364|Primary|Change From Baseline in Serum Lipid Levels at Visit 3||Baseline to Week 52 (Visit 3)|The ITT population was used for the analysis. For this particular outcome measure, 195 out of 301 subjects were analyzed.|||percent change||Standard Deviation|Mean
2659787|NCT01586364|Primary|Change From Baseline in Serum Lipid Levels at Visit 2||Baseline to Week 26 (Visit 2)|The ITT population was used for the analysis. For this particular outcome measure, 241 out of 301 subjects were analyzed.|||percent change||Standard Deviation|Mean
2659788|NCT01586364|Primary|Incidence of Adverse Events (AEs)||Week 13 (Phone Contact) to Week 56 (Visit 4)||||Participants|||Number
2659789|NCT01586338|Secondary|Percentage of Participants With Change in Concomitant Medication of Osteoarthritis Therapy at Week 26|Participants were asked about their perception regarding any additional Osteoarthritis medications or treatments or any changes in regimen or dosages compared to their baseline (Day 1) state. Any change in the therapy (less use of other therapies, more use of other therapies and no change in use of other therapies) during the study was reported.|Baseline up to Week 26|FAS population.|||percentage participants|||Number
2659790|NCT01586338|Secondary|Clinical Observer Global Assessment (COGA) Score|COGA (assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by the physician to rate participant's osteoarthritis condition. Percentage of participants with different categories of COGA score at baseline,Week 8, 12 and 26 are reported.|Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)|FAS population.|||percentage of participants|||Number
2659791|NCT01586338|Secondary|Patient Global Assessment (PTGA) Score|PTGA (self-assessment of target knee osteoarthritis condition) was measured using the 5 point Likert scale (0=very well, 1=well, 2=fair, 3=poor, 4=very poor) by participants to rate the osteoarthritis condition. Percentage of participants with different categories of PTGA score at baseline, Week 8, 12 and 26 are reported.|Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)|FAS population.|||percentage of participants|||Number
2659792|NCT01586338|Secondary|Change From Baseline in WOMAC A, B and C Score at Weeks 8, 12 and 26|WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). Each question was measured on a scale of 0-100 mm where lower score represents lower pain (better condition) and higher score represents higher pain. WOMAC A (measure of pain during walking on a flat surface) was sum of first five items with total score ranging from 0-500 mm, Lower score represents lower pain and higher score represents higher pain. WOMAC B (Stiffness) is the sum of the sixth and seventh item, it is in the range of 0-200 mm. WOMAC C (function) is the sum of the eighth to twenty-forth item, the score is in the range of 0-1700 mm.|Baseline, Week 8, 12 and 26 (missing data imputed by LOCF)|FAS population.|||mm||Standard Deviation|Mean
2659793|NCT01586338|Secondary|Change From Baseline in WOMAC A1 Subscore (Walking Pain) at Week 8 and 12|WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (walking pain) was measured on a scale of 0-100 mm, where lower score represents lower pain and higher score represents higher pain.|Baseline, Week 8 and Week 12 (missing data imputed by LOCF)|FAS population.|||mm||Standard Deviation|Mean
2659794|NCT01586338|Primary|Overview of Adverse Events (AE)|"An AE could be any unfavorable and unintended symptom, sign, disease or condition, or test abnormality whether or not considered related to the investigational product. A serious adverse event (SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAE): AEs that developed/worsened during the 'on treatment period' (from first dose of study drug until the end of study period). Category AE included participant with both serious and non-serious AE."|Up to Week 26|Safety Set included all participants who received at least one injection of Synvisc.|||percentage of participants|||Number
2659795|NCT01586338|Primary|Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) at Week 26|WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (walking pain) was measured on a scale of 0-100 mm, where lower score represents lower pain and higher score represents higher pain.|Baseline, Week 26 (missing data imputed by Last Observation Carried Forward [LOCF])|Full Analysis Set (FAS) included all participants who received at least one injection of Synvisc®. 5 participants were excluded from total enrolled (3 participant due to informed consent filled by family, and 2 participant due to no efficacy data after treatment).|||mm||Standard Deviation|Mean
2659796|NCT01586312|Secondary|Evolution of Cartilage Degeneration by T2 Relaxation Measurements in MRI (Cartigram)|"Magnetic Resonance imaging measurements of T2 relaxation (Cartigram) performed at 0, 6 and 12 months to quantify articular cartilage degeneration. The values (in milliseconds) are T1/2 for decay of the T2 MRI signals. Normal values are below 50 ms; values above 50 ms correspond to inflamed cartilage.~Mean (SD) are expressed as the number of values (of a total of 88 measurements) that are between 50 and 90 ms. A value =<4.4 is considered normal (can be attained by chance). Values above 4.4 are considered pathological. The worst possible is 88."|up to one year|The efficacy endpoint analysis will be based on all patients who have not committed major protocol violations, and have at least one assessment of efficacy of the end graft. 3 patients of the allogenic MSC treatment group were excluded from this analysis because of incomplete measurements.|||number of values (range 0-88)||Standard Deviation|Mean
2659797|NCT01586312|Secondary|Pain and Disability Evolution (WOMAC, Visual Analogue Scale, Lequesne Index and SF-12 Scores)|"Clinical review, questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months.~WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index): Questionnaire to quantify the pain, stiffness and physical function in patients with osteoarthritis of the knee or hip.~SF-12 (Short Form 12, an abbreviated form of SF36) is a questionnaire for the detection of changes in quality of life.~The visual analogue scale (VAS) is a psychometric response scale which can be used for subjective measurements of knee pain.~LEQUESNE algofunctional index: is a composite measure of pain and disability, with specific self-report questionnaires for knee (osteoarthritis).~All the scale ranges ranges (minimum and maximum scores) are between 0 and 100%.~Values are given in differences from baseline (usually negative values). More negative values show more improvement on both scales."|up to one year||||units on a scale||Standard Deviation|Mean
2659798|NCT01586312|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Adverse events reported. Clinical review and questionaires for pain, disability and quality of life at 0, 3, 6 and 12 months|Up to one year|"Efficacy evaluable patients (EEP): A patient has been considered evaluable whenever it has undergone the specified interventions (injection of hyaluronic acid or allogeneic MSC).~and~Safety population (SP): The population that includes all evaluable patients who have undergone one of the two study treatments."|||participants|||Number
2659815|NCT01586091|Primary|Flaire Diameter (mm)|Flaire diameter was measured with a transparent ruler as the mean of the largest diameter and the diameter at right angles to this.|24 hours per treatment|Please see Outcome measure description. Flair Diameter was measured in mm.|||mm||Standard Error|Mean
2659799|NCT01586195|Secondary|Number of Participants With an Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution.|Up to 42 months|Safety population defined as all enrolled participants who received any amount of vemurafenib on study.|||participants|||Number
2659800|NCT01586195|Secondary|Percentage of Participants With 12-Month Survival||Baseline to Month 12|ITT population defined as all enrolled participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
2659801|NCT01586195|Secondary|Percentage of Participants With 6-Month Survival||Baseline to Month 6|ITT population defined as all enrolled participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
2659802|NCT01586195|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first treatment to the date of death due to any cause. OS was summarized using Kaplan-Meier method.|Date of first treatment to date of death due to any cause (up to 42 months)|ITT population defined as all enrolled participants who received any amount of study drug.|||months||95% Confidence Interval|Median
2659803|NCT01586195|Secondary|Progression-free Survival (PFS)|PFS was assessed by the investigators according to RECIST v1.1 and defined as the time interval between the date of the first treatment dose and the date of disease progression or death due to any cause, whichever occurred first. PD was defined as a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions. PFS was summarized using Kaplan-Meier method.|From start of treatment up to first documentation of disease progression or death (up to 42 months)|ITT population defined as all enrolled participants who received any amount of study drug.|||months||Full Range|Median
2659804|NCT01586195|Secondary|Duration of Response|In participants with a confirmed CR or PR, duration of response was defined as the time interval between the date of the earliest qualifying response and the date of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a >/=30% decrease under baseline of the sum of diameters of all target lesions. PD was defined as a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions. Duration of response was summarized using Kaplan-Meier method.|From date of earliest qualifying response up to date of disease progression or death (up to 42 months)|ITT population defined as all enrolled participants who received any amount of study drug. Participants with a confirmed CR or PR were analyzed.|||months||Full Range|Median
2659805|NCT01586195|Secondary|Time to BORR|In participants with a confirmed CR or PR, time to BORR was defined as the interval between the date of first treatment and the date of first documentation of confirmed CR or PR (whichever occurred first). BORR was assessed by the investigators according to RECIST v1.1. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a >/=30% decrease under baseline of the sum of diameters of all target lesions. Participants without confirmed CR or PR were censored at the date of last tumor assessment. The time to response was summarized using univariate statistics.|From start of treatment up to first documentation of confirmed CR or PR (up to 42 months)|ITT population defined as all enrolled participants who received any amount of study drug. Participants with a confirmed CR or PR were analyzed.|||months||Full Range|Median
2659806|NCT01586195|Primary|Best Objective Response Rate (BORR)|BORR was assessed by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. BORR was defined as the number of participants whose best overall response was a complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a >/=30% decrease under baseline of the sum of diameters of all target lesions. BORR was summarized along with the associated exact 95% confidence interval (CI) using the method of Clopper-Pearson.|Up to 42 months|ITT population defined as all enrolled participants who received any amount of study drug.|||percentage of participants||95% Confidence Interval|Number
2659807|NCT01586156|Other Pre-specified|Echocardiogram Left Ventricular Cardiac Output|We hypothesized that carvedilol would be safe and tolerable and thus that Left ventricular cardiac output, a measure of heart function, would not decrease in participants on carvedilol.|6 months||||L/min||Standard Deviation|Mean
2659808|NCT01586156|Other Pre-specified|NT-proBNP (N-terminal Pro-B Type Natriuretic Peptide)|We hypothesized that carvedilol would be safe and tolerable and thus that NT-BNP, a measure of heart failure, would not increase in participants on carvedilol.|6 months||||pg/ml||Inter-Quartile Range|Median
2659809|NCT01586156|Other Pre-specified|6 Minute Walk Test|We hypothesized that carvedilol would not worsen 6 minute walk distance.|6 months||||meters||Standard Deviation|Mean
2659810|NCT01586156|Other Pre-specified|Echocardiogram Right Ventricular Systolic Pressure (RVSP)|We hypothesized that RVSP might decrease in participants on carvedilol.|6 months||||mm Hg||Standard Deviation|Mean
2659811|NCT01586156|Secondary|Beta-Adrenergic Receptor (Alprenolol Binding Assay)|We hypothesize that use of carvedilol in patients with PAH will increase beta- adrenergic receptor availability, and this will be measurable as a increase in alprenolol binding over time of drug use.|6 months||||abritrary units||Standard Deviation|Mean
2659812|NCT01586156|Secondary|Urinary cAMP (Cyclic Adenosine Monophosphate)/Creatinine|We hypothesize that use of carvedilol in patients with PAH will increase beta adrenergic receptor function and this will be measurable as an increase in cAMP measured in the urine at 6 months in participants in dose escalation carvedilol.|6 months||||umol/g||Inter-Quartile Range|Median
2659813|NCT01586156|Primary|Cardiac Glucose Uptake in FDG-PET (Fluorodeoxyglucose-Positron Emission Tomography)|We hypothesize that use of carvedilol in patients with PAH (Pulmonary Arterial Hypertension) will decrease the cardiac glucose utilization, and this will be measurable as a drop in fasting FDG-PET standardized uptake values of the heart at 6 months as compared to baseline|6 months|Paired analyses of baseline to 6 month FDG-PET SUV (standardized uptake value) within each group.|||standardized uptake value (SUV)||Inter-Quartile Range|Median
2659814|NCT01586091|Primary|Wheal Volume (cm3)|Wheal volume was measured by a non-contact three dimensional measurement system (PRIMOS contact, GFM Messtechnik GmbH, Teltow, Germany).|24 hours per treatment|Please see Outcome Measure Description. Wheal volume was measured in cm3. The units of measure are provided in the report of the this study protocol.|||cm3||Standard Error|Mean
2659816|NCT01586091|Primary|Pruritus as Assessed by the VAS Score|"We measured drug concentrations and various aspects of skin provocation testing such as itch intensity and wheal size. Measurements made at each time point were as followed: Pruritus was assessed every 30 s for 10 min after SPT using a visual analogue scale (VAS) score with a 0 and 100 at the two ex- tremes of an unmarked 100 mm line with higher values indicating greater puritus. The mean VAS for each 10 min was calculated and used as a primary end Point."|up to 10 minutes after skin prick test performed 24 hours after drug administration|Please see Outcome Measure Description. Itch was measured using a 10 point VAS.|||mm||Standard Error|Mean
2659817|NCT01586026|Primary|The Rate of Adverse Events in Group A (1-28 Day Flushing Interval) Versus Extended Accession Intervals in Group B (29-56 Day Flushing Interval), and Group C (57+ Days).|Subjects' maintenance flush intervals were collected by calculating the number of days since a previous flush. A total of 1,035 maintenance flush intervals were recorded at all sites. The numbers of flushing intervals available for analysis are 1,035 representing 49,696 patient days were recorded in 171 subjects.|100 days||||adverse events|||Number
2659818|NCT01585987|Secondary|Percentage of Participants With Immune-Related Best Overall Response (irBOR)|IrBOR rate was defined as the number of participants whose Immune-related Best Overall Response (irBOR) criteria was Immune-related Complete Response (irCR) or Immune-related Partial Response (irPR), divided by the total number of participants. The immune-related sum of products of diameters (irSPD) incorporates - in addition to the index lesions - measurable new lesions that may have developed on-study, providing an assessment that includes both index and new lesions. irCR=Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR=A 50% or greater decrease, relative to baseline of the irSPD, (based on irSPD of all index lesions and any measurable new lesions).|Randomization up to 91 irPFS events (Approximately 19 months)|All participants randomized to a treatment group were summarized.|||percentage of participants|||Number
2659819|NCT01585987|Secondary|Overall Survival (OS) at Study Completion|OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.|Randomization up to end of study, April 2015 (Approximately 28 months)|All participants randomized to a treatment group and who received at least one dose of active drug were summarized.|||Months||95% Confidence Interval|Median
2659820|NCT01585987|Secondary|Overall Survival (OS) at Primary Endpoint|OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.|Randomization up to 91 irPFS events (Approximately 19 months)|All participants randomized to a treatment group and who received at least one dose of active drug were summarized.|||Months||95% Confidence Interval|Median
2659821|NCT01585987|Secondary|Progression Free Survival (PFS) Per Modified World Health Organization (mWHO) Criteria|PFS per mWHO was defined as the time between the randomization date and the time of disease progression per mWHO criteria or death, whichever occurred first and was measured in months. mWHO criteria: New lesions always mean progression; Changes in non-measurable lesions contribute in the definitions of Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD).|Randomization up to 91 irPFS events (Approximately 19 months )|All participants randomized to a treatment group were summarized.|||Months||95% Confidence Interval|Median
2659822|NCT01585987|Primary|Immune-related Progression Free Survival (irPFS) as Per Assessment of a Blinded Independent Review Committee (IRC) According to Immune Related Response Criteria (irRC) Guidelines|irPFS is defined as the time between the randomization date and the time of disease progression per irRC or death, whichever occurs first. irRC criteria=Measurable new lesions: incorporated into the tumor burden (eg, added to the index lesions); do not define progression unless the total measurable tumor burden increases by the required amount (25%). New non-measurable lesions: not considered progression if the total measurable tumor burden is stable or shrinking. irPFS was measured in months.|Randomization up to 91 irPFS events (Approximately 19 months )|All participants who were randomized were summarized.|||Months||95% Confidence Interval|Median
2659823|NCT01585961|Secondary|Change in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score|"Change is calculated as 12 month overall AFEQT score minus score at screening. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding extremely limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding not at all limited, difficult or bothersome to all questions answered). Therefore a positive change in score corresponds to improvement in AF symptoms."|Screening to 12 Month Visit|Subset of Safety Population with non-missing AFEQT data at 12 months.|||units on a scale||Standard Deviation|Mean
2659824|NCT01585961|Secondary|Number of Patients With Outpatient Emergency Visits Related to Atrial Fibrillation||12 Month Visit|Population with Utilization Data|||participants|||Number
2659825|NCT01585961|Secondary|Number of Patients With Inpatient Hospital Visit(s) Related to Atrial Fibrillation||12 Month Visit|Population with Utilization Data|||participants|||Number
2659826|NCT01585961|Secondary|Number of Subjects With Lost Work Days, Related to AF, at 12 Month Visit||12 Month Visit|Subset of Safety Population with non-missing endpoint data.|||participants|||Number
2659827|NCT01585961|Secondary|Post-procedure AF Symptoms|Symptoms attributed to paroxysmal atrial fibrillation reported at 12 month visit|12 Month Visit|Subset of Safety Population with non-missing endpoint data.|||participants|||Number
2659828|NCT01585961|Secondary|Number of Patients With Repeat Ablations||1 year|Safety Population|||participants|||Number
2659829|NCT01585961|Secondary|Fluid Volume Delivered Via Ablation Catheter||Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.|||mL||Standard Deviation|Mean
2659830|NCT01585961|Secondary|Total Radiofrequency (RF) Time|Total RF time is defined as the total time that RF energy is delivered during the procedure.|Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.|||minutes||Standard Deviation|Mean
2659831|NCT01585961|Secondary|Mean Number of Radiofrequency (RF) Applications|RF applications is defined as the number of times RF energy is delivered during the procedure.|Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.|||number of applications||Standard Deviation|Mean
2659832|NCT01585961|Primary|Acute Procedural Success|Confirmation of entrance and/or exit block across all targeted pulmonary veins.|Day 0 (procedure)|Safety population|||participants|||Number
2659834|NCT01585961|Primary|Total Fluoroscopy Time|The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total time.|Day 0 (procedure)|Subset of Safety Population with non-missing endpoint data.|||minutes||Standard Deviation|Mean
2659835|NCT01585779|Secondary|Change in New York Heart Association (NYHA) Classification .|Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.|Preimplant through 12 months||||participants|||Number
2659836|NCT01585779|Secondary|Change in New York Heart Association (NYHA) Classification|Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.|Preimplant through 6 months||||participants|||Number
2659837|NCT01585779|Secondary|Change in New York Heart Association (NYHA) Classification|Assess the effect of TV repair with the study ring on the tricuspid valve functional status by analysis of the New York Heart Association (NYHA) classification from pre-implant through 12 months post-implant.|Preimplant through Discharge||||participants|||Number
2659838|NCT01585779|Secondary|Demographic Data|Characterize the patient population for which an annuloplasty ring is chosen to repair TV insufficiency and assess the effect of TV repair with the study ring on the tricuspid valve functional status|Baseline||||participants|||Number
2659839|NCT01585779|Secondary|Change in the RV Fractional Area|The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.|Preimplant through 12 Months||||percent||Inter-Quartile Range|Median
2659840|NCT01585779|Secondary|Change in the RV Fractional Area|The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.|Preimplant through 6 Months||||percent||Inter-Quartile Range|Median
2659841|NCT01585779|Secondary|Change in the RV Fractional Area|The secondary objective is the evaluation of effect of TV repair with the study ring on RV fractional area. Change in the RV fractional area preimplant through 12 months post-implant.|Preimplant through Discharge||||percent||Inter-Quartile Range|Median
2659842|NCT01585779|Secondary|Change in the Tricuspid Annular (Basal) Diameter|The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant|Preimplant through 12 Months||||mm||Inter-Quartile Range|Median
2659843|NCT01585779|Secondary|Change in the Tricuspid Annular (Basal) Diameter|The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant|Preimplant through 6 Months||||mm||Inter-Quartile Range|Median
2659844|NCT01585779|Secondary|Change in the Tricuspid Annular (Basal) Diameter|The secondary objective is the evaluation of effect of TV repair with the study ring on Tricuspid annular (basal) diameter. Change in the tricuspid annular (basal) diameter from preimplant through 12 months post-implant|Preimplant through Discharge||||mm||Inter-Quartile Range|Median
2659845|NCT01585779|Secondary|Change in the Right Ventricle (RV) Diastolic Area|The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant|Preimplant through 12 Months||||mm^2||Inter-Quartile Range|Median
2659846|NCT01585779|Secondary|Change in the Right Ventricle (RV) Diastolic Area|The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant.|Preimplant through 6 Months||||mm^2||Inter-Quartile Range|Median
2659847|NCT01585779|Secondary|Change in the Right Ventricle (RV) Diastolic Area|The secondary objective is the evaluation of effect of TV repair with the study ring on Right ventricle (RV) diastolic area at end diastole. Change in the Right ventricle (RV) diastolic area from preimplant through 12 months post-implant.|Preimplant through Discharge||||mm^2||Inter-Quartile Range|Median
2659848|NCT01585779|Primary|Change in the Degree of TV Leaflet Tethering Height|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant|Preimplant through 12 Months||||mm||Inter-Quartile Range|Median
2659849|NCT01585779|Primary|Change in the Degree of TV Leaflet Tethering Height|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant.|Preimplant through 6 Months||||mm||Inter-Quartile Range|Median
2659850|NCT01585779|Primary|Change in the Degree of TV Leaflet Tethering Height|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet tethering height. Change in the degree of TV leaflet tethering height from pre-implant through 12 months post-implant.|Preimplant through Discharge||||mm||Inter-Quartile Range|Median
2659851|NCT01585779|Primary|Change in the Degree of TV Leaflet Coaptation Length|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.|Preimplant through 12 Months||||mm||Inter-Quartile Range|Median
2659852|NCT01585779|Primary|Change in the Degree of TV Leaflet Coaptation Length|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.|Preimplant through 6 Months||||mm||Inter-Quartile Range|Median
2659951|NCT01585441|Secondary|Change in Central Retinal Thickness in the Study Eye at Month 3 Compared to Baseline|Central retinal thickness was assessed by spectral-domain optical coherence tomography (SD-OCT).|Month 3||||μm|Participants|Standard Deviation|Mean
2659853|NCT01585779|Primary|Change in the Degree of TV Leaflet Coaptation Length|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the TV leaflet coaptation length. Change in the degree of TV leaflet coaptation length from preimplant through 12 months postimplant.|Preimplant through Discharge||||mm||Inter-Quartile Range|Median
2659854|NCT01585779|Primary|The Mean Gradient Across the Tricuspid Valve|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant|12 months||||mmHg||Inter-Quartile Range|Median
2659855|NCT01585779|Primary|The Mean Gradient Across the Tricuspid Valve|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant|6 months||||mmHg||Inter-Quartile Range|Median
2659856|NCT01585779|Primary|The Mean Gradient Across the Tricuspid Valve|The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment by analysis of the mean gradient across the tricuspid valve. The mean gradient across the tricuspid valve measured at discharge, 6 months, and 12 months post-implant|Discharge||||mmHg||Inter-Quartile Range|Median
2659857|NCT01585779|Primary|Change in the Degree of Tricuspid Regurgitation|"The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment.~Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant."|Preimplant through 12 Months||||participants|||Number
2659858|NCT01585779|Primary|Change in the Degree of Tricuspid Regurgitation|"The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment.~Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant."|Preimplant through 6 Months||||participants|||Number
2659859|NCT01585779|Primary|Change in the Degree of Tricuspid Regurgitation|"The primary objective is the evaluation of hemodynamic performance of the TV postimplant of a tricuspid annuloplasty ring in a postmarket environment.~Degree of TV regurgitation - Change in the degree of tricuspid regurgitation from preimplant through 12 months postimplant."|Preimplant through Discharge||||participants|||Number
2659860|NCT01585766|Secondary|Number of Participants Positive for Anti-Drug Antibodies to MEDI-551|A participant was considered anti-drug antibody positive across the study if they had a positive reading at any time point during the study.|Days 1, 29, 85 and 169|Safety Population|||Participants|||Count of Participants
2659861|NCT01585766|Secondary|Maximum Change From Baseline in Absolute CD20 of Peripheral Blood B-cell Count to LTFU|The maximum degree of depletion (intensity) measured during the course of the study for each participant by subtracting 100 from the lowest observed percent of baseline value.|Baseline (Days -28 to -1) to LTFU (Up to 18 months after EDV or 24 Week treatment period)|Safety Population|||Percentage of cells||Standard Deviation|Mean
2659862|NCT01585766|Secondary|Duration of Suppression Greater Than or Equal to 90 % of CD20 B-cell Count|Time in days of last observation where CD20 counts remain at or below 10% of baseline. Participants whose samples are available were analyzed for this outcome measure.|Baseline (Days -28 to -1) to LTFU (Up to 18 months after EDV or 24 Week treatment period)|Safety Population. No participants were included in placebo-IV-SC group since no participant reached 90% depletion.|||Day||Full Range|Median
2659863|NCT01585766|Secondary|Time to 90 Percent (%) CD20 B-cell Depletion|Time in days of first observation where CD20 counts fall to or below 10 percent (%) of baseline.|Baseline (Days -28 to -1) to long-term follow-up (LTFU) (Up to 18 months after EDV or 24 Week treatment period)|Safety Population. No participants in placebo-IV-SC group reached 90% CD20 B-cell depletion.|||Day||Full Range|Median
2659864|NCT01585766|Secondary|Absolute CD20 B-cell Count at Baseline|Baseline absolute CD20 count is measured as the average between screening and predose on Day 1.|Baseline (Days -28 to -1)|Safety Population|||cells/mcL||Standard Deviation|Mean
2659865|NCT01585766|Secondary|Absolute Subcutaneous Bioavailability (F%) of MEDI-551|Bioavailability (F%) is the fraction of the study drug absorbed through non-intravenous administration compared with the corresponding intravenous administration of the same drug.|Predose (Day 1) and Days 4, 8, 15, 29, 57, 85, 113, 141, and 169|Safety Population|||Percentage of bioavailability|||Number
2659866|NCT01585766|Secondary|Terminal Elimination Half-life (t1/2) of MEDI-551|The terminal elimination half-life (t1/2) was estimated based on the plasma concentrations of MEDI-551.|Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169|Safety Population|||Day||Standard Deviation|Mean
2659867|NCT01585766|Secondary|Clearance of MEDI-551|Systemic clearance (CL) for MEDI-551 IV cohorts and apparent clearance (CL/F) for MEDI-551 SC cohorts were calculated|Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169|Safety Population|||mL/day||Standard Deviation|Mean
2659868|NCT01585766|Secondary|Dose Normalized Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC 0-infinity/D) of MEDI-551|The AUC (0-infinity)/D is the area under concentration-time curve extrapolated to infinity post dose normalized by MEDI-551.|Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169|Safety Population|||mcg*day/mL/mg||Standard Deviation|Mean
2659869|NCT01585766|Secondary|Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC 0-infinity) of MEDI-551|The area under the concentration-time curve from dosing extrapolated to infinity (AUC 0-infinity) of MEDI-551.|Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169|Safety Population|||mcg*day/mL||Standard Deviation|Mean
2659886|NCT01585558|Primary|Change From Baseline in Weight||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||kg||Standard Deviation|Mean
2659870|NCT01585766|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC 0-last) of MEDI-551|The area under the concentration time curve from time 0 (dosing time) to the last measurable concentration (AUC 0-last) of MEDI-551.|Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169|Safety Population|||microgram*day per milliliter(mcg*day/mL)||Standard Deviation|Mean
2659871|NCT01585766|Secondary|Maximum Observed Serum Concentration (Cmax) of MEDI-551|The maximum observed serum concentration (Cmax) of MEDI-551.|Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169|Safety Population|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2659872|NCT01585766|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-551|The time to reach the maximum observed serum concentration of MEDI-551.|Predose (Day 1) and Postdose (IV Cohorts only), Days 4 (SC Cohorts only), 8, 15 Predose and Postdose (IV Cohorts only), 29, 57, 85, 113, 141, and 169|Safety Population|||Day||Full Range|Median
2659873|NCT01585766|Primary|Number of Participants With Vital Sign Abnormalities Reported as TEAEs|Vital sign parameters included blood pressure, temperature, pulse rate, and respiratory rate. The number of participants with TEAEs related to vital signs in participants were reported.|From study drug administration (Day 1) through the end of treatment period (Day 169)|Safety Population|||Participants|||Count of Participants
2659874|NCT01585766|Primary|Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs|Any clinically significant change in laboratory evaluations were recorded as AEs. The following parameters were analyzed for laboratory evaluations: haematology, serum chemistry, and urinalysis. Number of participants with TEAEs related to laboratory evaluations were reported.|From study drug administration (Day 1) through the end of treatment period (Day 169)|Safety Population|||Participants|||Count of Participants
2659875|NCT01585766|Primary|Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)|A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, life-threatening, initial or prolonged inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect in the offspring of a participant who received the study drug. The TESAEs were the events between administration of study drug (Day 1) and long term follow up period (up to 18 months after early discontinuation visit or 24-week treatment period) that were absent before treatment or that worsened relative to pre-treatment state. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0|From study drug administration (Day 1) through the long term follow up period (up to 18 months after early discontinuation visit or 24 week treatment period).|Safety Population|||Participants|||Count of Participants
2659876|NCT01585766|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A TEAE were the events between administration of study drug (Day 1) and Day 169 that were absent before treatment or that worsened relative to pre-treatment state. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0|From study drug administration (Day 1) through the end of treatment period (Day 169)|Safety Population is defined as all participants who received any amount of study drug.|||Participants|||Count of Participants
2659877|NCT01585597|Secondary|Modified Rankin Scale 0-2|"Modified Rankin Score 0=no symptoms~no significant disability~slight disability needs help~moderate disability~moderate serve disability~severe disability 0-2 = good outcome 3-5= poor outcome"|90 days post hospitalization||||participants Modified Rankin Scal 0-2|||Number
2659878|NCT01585597|Primary|Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation|Asymptomatic and symptomatic Hemorrhages defined as homogenous density occupying >30% of the infarct zone with mass effect|24 Hours||||participants|||Number
2659879|NCT01585584|Primary|Sustained Virologic Response (SVR) at 24 Weeks Post Treatment|Sustained Virologic Response (SVR) is evaluated 24 weeks after end of treatment and defined as undetectable plasma HCV-RNA at follow up week 24. HCV RNA is measured using Cobas TaqMan.Of the 6 subjects who completed the treatment, 3 obtained SVR at 24 weeks post treatment.|24 weeks after treatment|Patients who completed full course of treatment|||participants|||Number
2659880|NCT01585558|Primary|Change From Baseline in BMI||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||kg/m^2||Standard Deviation|Mean
2659881|NCT01585558|Primary|Change From Baseline in Weight||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||kg||Standard Deviation|Mean
2659882|NCT01585558|Primary|Change From Baseline in Pulse Rate||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||bpm||Standard Deviation|Mean
2659883|NCT01585558|Primary|Change From Baseline in DBP||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||mmHg||Standard Deviation|Mean
2659884|NCT01585558|Primary|Change From Baseline in SBP||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||mmHg||Standard Deviation|Mean
2659885|NCT01585558|Primary|Change From Baseline in BMI||Baseline to Week 26|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||kg/m^2||Standard Deviation|Mean
2659887|NCT01585558|Primary|Change From Baseline in Pulse Rate||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||bpm||Standard Deviation|Mean
2659888|NCT01585558|Primary|Change From Baseline in Diastolic Blood Pressure (DBP)||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||mmHg||Standard Deviation|Mean
2659889|NCT01585558|Primary|Change From Baseline in Systolic Blood Pressure (SBP)||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 66 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||mmHg||Standard Deviation|Mean
2659890|NCT01585558|Primary|Change From Baseline in Specific Gravity of Urine||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 57 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||units||Standard Deviation|Mean
2659891|NCT01585558|Primary|Change From Baseline in pH of Urine||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 57 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||pH||Standard Deviation|Mean
2659892|NCT01585558|Primary|Change From Baseline in Specific Gravtiy of Urine||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 64 subjects in the ospemifene 30 mg group, 64 out of 69 subjects in the ospemifene 60 mg group, and 41 out of 49 subjects in the placebo group were analyzed.|||units||Standard Deviation|Mean
2659893|NCT01585558|Primary|Change From Baseline in pH of Urine||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 64 subjects in the ospemifene 30 mg group, 64 out of 69 subjects in the ospemifene 60 mg group, and 41 out of 49 subjects in the placebo group were analyzed.|||pH||Standard Deviation|Mean
2659894|NCT01585558|Primary|Change From Baseline in Hematocrit Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||percent change||Standard Deviation|Mean
2659895|NCT01585558|Primary|Change From Baseline in Hemoglobin Levels||Baseine to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||g/dL||Standard Deviation|Mean
2659896|NCT01585558|Primary|Change From Baseline in Erythrocyte (RBC) Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||(x10(12)/L)||Standard Deviation|Mean
2659897|NCT01585558|Primary|Assessment of Hematology Test Values|Change from baseline|Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||(x10(9)/L)||Standard Deviation|Mean
2659898|NCT01585558|Primary|Change From Baseline in Hematocrit Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||percent change||Standard Deviation|Mean
2659899|NCT01585558|Primary|Change From Baseline in Hemogobin Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||g/dL||Standard Deviation|Mean
2659900|NCT01585558|Primary|Change From Baseline in Erythrocyte (RBC) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||(x10(12)/L)||Standard Deviation|Mean
2659901|NCT01585558|Primary|Assessment of Hematology Tests|Change from baseline|Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 51 out of 62 subjects in the ospemifene 30 mg group, 61 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||(x10(9)/L)||Standard Deviation|Mean
2659902|NCT01585558|Primary|Assessment of Breast Palpation|Breast palpation was done by the investigator to assess abnormalities in the breast.|Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||Participants|||Number
2659903|NCT01585558|Primary|Assessment of Breast Palpation|Breast palpation was done by the investigator to assess abnormalities in the breast.|Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 65 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||Participants|||Number
2659904|NCT01585558|Primary|Change From Baseline in Thromboplastin Time||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||s||Standard Deviation|Mean
2659905|NCT01585558|Primary|Change From Baseline in Protein S Ag (Free), P Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||percent change||Standard Deviation|Mean
2659906|NCT01585558|Primary|Change From Baseline in Protein C Ag, P Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||percent change||Standard Deviation|Mean
2659907|NCT01585558|Primary|Change From Baseline in Fibrinogen Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||mg/dL||Standard Deviation|Mean
2659908|NCT01585558|Primary|Change From Baseline in Antithrombin Antigen, P Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||percent change||Standard Deviation|Mean
2659909|NCT01585558|Primary|Change From Baseline in Thromboplastin Time||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||s||Standard Deviation|Mean
2659910|NCT01585558|Primary|Change From Baseline in Protein S Ag (Free), P Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||percent change||Standard Deviation|Mean
2659911|NCT01585558|Primary|Change From Baseline in Protein C Ag, P Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||percent change||Standard Deviation|Mean
2659912|NCT01585558|Primary|Change From Baseline in Fibrinogen Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||mg/dL||Standard Deviation|Mean
2659913|NCT01585558|Primary|Change From Baseline in Antithrombin Antigen, P Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||percent change||Standard Deviation|Mean
2659914|NCT01585558|Primary|Change From Baseline in Testosterone (Free) Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||ng/dL||Standard Deviation|Mean
2659915|NCT01585558|Primary|Change From Baseline in Testosterone (Total) Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||ng/dL||Standard Deviation|Mean
2659916|NCT01585558|Primary|Assessment of Mammography|Mammography was done for the detection of characteristic masses and microcalcifications in the breast.|Week 52 (Visit 6)||||Participants|||Number
2659917|NCT01585558|Primary|Change From Baseline in SHBG Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||nmol/L||Standard Deviation|Mean
2659918|NCT01585558|Primary|Change From Baseline in FSH Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||IU/L||Standard Deviation|Mean
2659919|NCT01585558|Primary|Change From Baseline in LH Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||IU/L||Standard Deviation|Mean
2659920|NCT01585558|Primary|Change From Baseline in E2 Levels||Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||pg/mL||Standard Deviation|Mean
2659921|NCT01585558|Primary|Change From Baseline in Testosterone (Free) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||ng/dL||Standard Deviation|Mean
2659922|NCT01585558|Primary|Change From Baseline in Testosterone (Total) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||ng/dL||Standard Deviation|Mean
2659944|NCT01585441|Secondary|Change in Urinary Levels of Cortisol at the Safety Visit Compared to Baseline|The mean change is reported in micrograms (μg).|Final Study Visit|One finasteride participant's cortisol lab value could not be calculated due to Cortisol, Urine <1.5 ng/mL.|||μg||Standard Deviation|Mean
2659923|NCT01585558|Primary|Change From Baseline in Sex Hormone Binding Globulin (SHBG) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||nmol/L||Standard Deviation|Mean
2659924|NCT01585558|Primary|Change From Baseline in Follicle Stimulating Hormone (FSH) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||IU/L||Standard Deviation|Mean
2659925|NCT01585558|Primary|Change From Baseline in Luteinizing Hormone (LH) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||IU/L||Standard Deviation|Mean
2659926|NCT01585558|Primary|Change From Baseline in Estradiol (E2) Levels||Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 63 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||pg/mL||Standard Deviation|Mean
2659927|NCT01585558|Primary|Change From Baseline in Visual Evaluation of the Vagina|Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).|Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 35 out of 49 subjects in the placebo group were analyzed.|||Units on a scale||Standard Deviation|Mean
2659928|NCT01585558|Primary|Change From Baseline in Visual Evaluation of the Vagina|Petechiae, pallor, friability, dryness in the mucosa, and redness in the mucosa were assessed on a 4-point scale (0=None, 1=Mild, 2=Moderate, 3=Severe).|Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 52 out of 62 subjects in the ospemifene 30 mg group, 65 out of 69 subjects in the ospemifene 60 mg group, and 42 out of 49 subjects in the placebo group were analyzed.|||Units on a scale||Standard Deviation|Mean
2659929|NCT01585558|Primary|Assessment of Endometrial Safety With a TVU|Mean change in endometrial thickness from baseline|Baseline to Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 46 out of 62 subjects in the ospemifene 30 mg group, 52 out of 69 subjects in the ospemifene 60 mg group, and 30 out of 49 subjects in the placebo group were analyzed.|||mm||Standard Deviation|Mean
2659930|NCT01585558|Primary|Assessment of Endometrial Safety With a Transvaginal Ultrasound (TVU)|Mean change in endometrial thickness from baseline|Baseline to Week 26 (Visit 5)|The ITT population was used for the analysis. For this particular outcome measure, at Week 26, 50 out of 62 subjects in the ospemifene 30 mg group, 60 out of 69 subjects in the ospemifene 60 mg group, and 37 out of 49 subjects in the placebo group were analyzed.|||mm||Standard Deviation|Mean
2659931|NCT01585558|Primary|Mean Change in Blood Chemistry Parameters||Baseline to Week 52 (Visit 6)||||U/L||Standard Deviation|Mean
2659932|NCT01585558|Primary|Mean Change in Blood Chemistry Parameters||Baseline to Week 26 (Visit 5)||||U/L||Standard Deviation|Mean
2659933|NCT01585558|Primary|Mean Percent Change From Baseline in Serum Lipids||Baseline to Week 52 (Visit 6)||||percent change||Standard Deviation|Mean
2659934|NCT01585558|Primary|Mean Percent Change From Baseline in Serum Lipids||Baseline to Week 26 (Visit 5)||||percent change||Standard Deviation|Mean
2659935|NCT01585558|Primary|Assessment of Endometrial Biopsy|Assessments were based on Blaustein's classification.|Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, at Week 52, 46 out of 62 subjects in the ospemifene 30 mg group, 55 out of 69 subjects in the ospemifene 60 mg group, and 32 out of 49 subjects in the placebo group were analyzed.|||Participants|||Number
2659936|NCT01585558|Primary|Assessment of Cervical Pap Smear Samples|Cervical Pap smear samples were used to evaluate: atypical squamous cells of undetermined significance (ASC-US), squamous intraepithelial lesions (SILs), intraepithelial lesions or malignancy, and reactive endocervical cells and/or metaplastic cells.|Week 52 (Visit 6)|The ITT population was used for the analysis. For this particular outcome measure, 49 out of 62 subjects in the ospemifene 30 mg group, 58 out of 69 subjects in the ospemifene 60 mg group, and 34 out of 49 subjects in the placebo group were analyzed.|||Participants|||Number
2659937|NCT01585558|Primary|Incidence of Adverse Events (AEs)||Week 20 (Phone Contact) to Week 56 (Visit 7)||||Participants|||Number
2659938|NCT01585441|Secondary|Number of Participants Presenting No Change in Fluid Leakage at the Safety Visit Compared to Baseline|Changes in leakage as observed on fluorescein angiography (FA)|Final Study Visit||||participants|||Number
2659939|NCT01585441|Secondary|Number of Participants Presenting No Change in Fluid Leakage at Month 3 Compared to Baseline|Changes in leakage as observed on fluorescein angiography (FA)|Month 3||||participants|||Number
2659940|NCT01585441|Secondary|Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at the Safety Visit Compared to Baseline||Final Study Visit|One placebo participant was not evaluated at the final safety visit, as the participant completed the study at the Month 3 visit.|||participants|||Number
2659941|NCT01585441|Secondary|Number of Participants Presenting No Change in Size of Existing Plaque(s) on Indocyanine Green (ICG) Angiography at Month 3 Compared to Baseline||Month 3||||participants|||Number
2659942|NCT01585441|Secondary|Number of Participants Presenting No Change in Autofluorescence Patterns at the Safety Visit Compared to Baseline|Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging|Final Study Visit|One placebo participant was not evaluated at the final safety visit, as the participant completed the study at the Month 3 visit.|||participants|||Number
2659943|NCT01585441|Secondary|Number of Participants Presenting No Change in Autofluorescence Patterns at Month 3 Compared to Baseline|Autofluorescence patterns as observed on Fundus Autofluorescence (FAF) imaging|Month 3||||participants|||Number
2659945|NCT01585441|Secondary|Change in Urinary Levels of Cortisol at Month 3 Compared to Baseline|The mean change is reported in micrograms (μg).|Month 3||||μg||Standard Deviation|Mean
2659954|NCT01585441|Secondary|Percent Change in Subretinal Fluid Volume in the Study Eye at Month 3 Compared to Baseline|"Subretinal fluid volume will be determined by manually moving the segmentation lines of the optical coherence tomography (OCT) image using the Edit Segmentation function of the Cirrus™ HD-OCT software. The segmentation lines will be edited to outline the inner and outer borders of the subretinal fluid pocket. This will be done manually for all the individual B-scans of each OCT image, after which the software algorithm automatically calculates the subretinal fluid volume."|Month 3||||percent change|Participants|Standard Deviation|Mean
2659955|NCT01585441|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at the Safety Visit Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Final Study Visit||||ETDRS letters|Participants|Standard Deviation|Mean
2659956|NCT01585441|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Month 3 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Month 3||||ETDRS letters|Participants|Standard Deviation|Mean
2659957|NCT01585441|Secondary|Number of Participants Who Withdrew From the Study||Duration of the study, up to 1.5 years||||participants|||Number
2659958|NCT01585441|Secondary|Number of Participants With Adverse Reactions Related to the Investigational Product|The outcome measure refers only to events that were classified as related to the investigational product.|Duration of the study, up to 1.5 years||||participants|||Number
2659959|NCT01585441|Primary|Proportion of Participants With a Reduction in Subretinal Fluid Volume ≥ 50% at 3 Months Compared to Baseline|"This is the primary outcome measure for publication of study results. Subretinal fluid volume will be determined by manually moving the segmentation lines of the optical coherence tomography (OCT) image using the Edit Segmentation function of the Cirrus™ HD-OCT software. The segmentation lines will be edited to outline the inner and outer borders of the subretinal fluid pocket. This will be done manually for all the individual B-scans of each OCT image, after which the software algorithm automatically calculates the subretinal fluid volume."|Month 3||||participants|Participants||Number
2659960|NCT01585441|Primary|Proportion of Participants With an Improvement in Best-corrected Visual Acuity (BCVA) ≥ 15 Letters at 3 Months Compared to Baseline.|This is the regulatory filing primary outcome measure. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Month 3||||participants|Participants||Number
2659961|NCT01585428|Secondary|Number of Patients With Serious and Non-serious Adverse Events|Here is the number of serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v3.0). A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. A non-serious adverse event is any untoward medical occurrence.|51 months and 18 days||||Participants|||Count of Participants
2659962|NCT01585428|Primary|Number of Participants With an Objective Clinical Response|Patients must have a partial response (PR) or complete response (CR) at least 4 months after cell infusion to count towards clinical response. Clinical response is assessed by the Response Criteria in Solid Tumors (RECIST) v1.0. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Complete response is disappearance of all target lesions. Progression is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.|4 months after cell infusion||||Participants|||Count of Participants
2659963|NCT01585324|Secondary|Number of Participants With Thrombocytopenia Among Participants With or Without SVR||Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2659964|NCT01585324|Secondary|Number of Participants With Neutropenia Among Participants With or Without SVR||Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2659965|NCT01585324|Secondary|Number of Participants With Reduction in Ribavirin Dose Due to Drop in Hemoglobin Among Participants With or Without SVR||Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2659966|NCT01585324|Secondary|Lowest Hemoglobin Level During Treatment Among Participants With or Without SVR|The mean minimum hemoglobin value achieved during the treatment was assessed in the group of participants who achieved SVR and in the group of participants without SVR.|Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.|||g/L||Standard Deviation|Mean
2659967|NCT01585324|Secondary|Number of Participants With Decrease in Hemoglobin|The drop in hemoglobin level at Week 12 compared to level at baseline was assessed and categorized in pre-defined categories (up to 20, 20-40, greater than [>] 40 g/L) for the group of participants who achieved SVR and in the group of participants without SVR.|Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2659968|NCT01585324|Primary|Change From Baseline in Hemoglobin Level at Week 12 of Treatment Among Participants With or Without SVR|Change in hemoglobin level from a baseline level was assessed in the group of participants who achieved SVR and in the group of participants without SVR.|Baseline and Week 12|ITT population included all enrolled participants who received at least 1 dose of study drug.|||grams per liter (g/L)||Standard Deviation|Mean
2659969|NCT01585324|Primary|Percentage of Participants With Sustained Virological Response (SVR) 24 Weeks After End of Treatment|SVR was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.|24 weeks after the end of treatment (72 weeks)|ITT population included all enrolled participants who received at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2659970|NCT01585298|Secondary|Number of Patients With Cardiac Adverse Events|The number of participants with the occurrence of subsequent cardiac adverse events (AEs) and serious cardiac AEs during study was assessed. Cardiac events were defined as the following Medical Dictionary for Regulatory Activities (MedDRA) preferred terms: angina pectoris, chest discomfort, dizziness, dyspnoea, dyspnoea exertional, fatigue, palpitations, syncope, vertigo, vertigo positional and vision blurred.|7 days|Safety set: The safety set consisted of all enrolled participants for whom safety information was collected. Two patients of the safety analysis set discontinued the study without having received treatment, but safety information was collected on these two patients.|||Participants|||Number
2659971|NCT01585298|Secondary|Number of Participants With Bradyarrhythmic Electrocardiogram (ECG) Events|The number of participants with bradyarrhythmic electrocardiogram (ECG) events was assessed. Bradyarrhythmic ECG events are defined as QTc Fridericia time > 450 ms for males and > 470 ms for females.|up to day 7|Safety set: The safety set consisted of all enrolled participants for whom safety information was collected. Two patients of the safety analysis set discontinued the study without having received treatment, but safety information was collected on these two patients.|||Participants|||Number
2659972|NCT01585298|Secondary|Number of Participants With Prolonged QTc Interval (Friderica)|"Number of patients with conduction abnormalities such as QT prolongation, first degree AV block during treatment initiation.~The QT interval is a period between the activation and the regeneration of ventricular contraction. A prolonged QT interval can be a potential marker of cardiac arrhythmias.~Two patients of the safety analysis set discontinued the study without having received treatment, but safety information was collected on these two patients."|baseline post-dose|"The safety set, which consisted of all enrolled participants for whom safety information was collected, was considered for the analysis. Only participants, who had baseline post-dose QTc interval data, were analyzed.~Of the 6998 patients, 6844 patients had complete baseline post-dose QTc interval data."|||Participants|||Number
2659973|NCT01585298|Primary|Number of Patients With Heart Rate Below 45 Beats Per Minute (BPM)|Number of patients with heart rate below 45 beats bpm in ECG during first dose observation|baseline during 6 hour monitoring post dose|Safety set: The safety set consisted of all enrolled participants for whom safety information was collected. Two patients of the safety analysis set discontinued the study without having received treatment, but safety information was collected on these two patients.|||Participants|||Number
2659974|NCT01585298|Primary|Participants With 2nd or 3rd Degree Atrioventricular (AV) Block|AV Blocks/Heart block is an abnormal heart rhythm where the heart beats too slowly; the electrical signals that tell the heart to contract are partially intermittent (Type 2:1) or slowed (1st and 2nd degree) or blocked (3rd degree) between the upper chambers (atria) and the lower chambers (ventricles). In 2nd degree AV Blocks, electrical impulses are intermittent (type 2:1) or delayed w/ each subsequent heartbeat (Mobitz type I) until a beat fails to reach the ventricles entirely. This type of block often is physiologic and observed in a highly relaxed state & during sleep. In 2nd degree AV Blocks type II, the atria electrical impulses are unable to reach the ventricles, a more serious condition. In 3rd degree AV Blocks (complete heart block), none of the electrical impulses reach either the atria or the ventricles. Patients can experience simultaneously both types of 2nd or 3rd degree AV Blocks without any symptoms.|baseline, during 6 hour monitoring post first dose observation|Safety set: The safety set consisted of all enrolled participants for whom safety information was collected. Two patients of the safety analysis set discontinued the study without having received treatment, but safety information was collected on these two patients.|||Participants|||Number
2659975|NCT01585272|Secondary|Percentage of Patients Successfully Titrated to Rivastigmine Patch 10 cm^2|The percentage of patients successfully titrated to rivastigmine patch 10 cm2|Baseline through week 52|Safety population: All enrolled subjects who received 3 mg b.i.d Exelon capsule for more than 4 weeks and used at least one dose of Exelon patch therapy.|||Percentage of participants|||Number
2659976|NCT01585272|Secondary|The Discontinuation Rate Due to the Treatment Switching From Oral Capsule to Rivastigmine Patch Treatment|The discontinuation rate due to the treatment switching from oral capsule to patch treatment. For patients who discontinue earlier due to intolerance of patch treatment, the proportion will be analyzed. Both the discontinuation rate of 5 cm2 and 10 cm^2 patch therapy will be presented.|Baseline through week 52|Of the patients treated, N=121, number of patients analyzied were those who received 5cm patch (n=114) and those who received 10cm patch (n=96)|||Participants|||Number
2659977|NCT01585272|Secondary|Change From Baseline in Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)|The changes in Alzheimer Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) of patients with Alzheimer's disease treated with Exelon 5 cm^2 Patch at Week 28 and Exelon 10 cm^2 Patch at Week 52 versus baseline, the treatment-switching day at Week 4. ADAS-Cog has been used as the major cognitive measure of anti-dementia drugs. The total score range is 0 to 70 points, with higher scores indicating greater cognitive impairment. The assessments will be conducted at Visit, 2, 8, 11 and 17 (Week 4 (baseline), 16, 28 and 52).|Baseline, week 16, 28 and 52|ITT population: All enrolled subjects who received 3 mg b.i.d Exelon capsule orally for 4 weeks and at least one dose of Exelon patch therapy.|||Score||Standard Deviation|Mean
2659978|NCT01585272|Secondary|Change From Baseline in Mini-Mental Status Examination (MMSE)|The changes in Mini-Mental Status Examination (MMSE) of patients with Alzheimer's disease treated with Exelon 5 cm^2 Patch at Week 28 and Exelon 10 cm2 Patch at Week 52 versus baseline, the treatment-switching day at Week 4. MMSE is a multi-item instrument that examines orientation, registration, attention, calculation, recall, visuospatial ability and language. The total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline. The assessments will be conducted at Visit 1, 2, 8, 11 and 17 (screening, Week 4 (baseline), 16, 28 and 52).|Baselin, week 16, 28 and 52|ITT population: All enrolled subjects who received 3 mg b.i.d Exelon capsule orally for 4 weeks and at least one dose of Exelon patch therapy|||Score||Standard Deviation|Mean
2660977|NCT01575275|Secondary|Overall Survival, by Periodic Follow up Review of the Patient Charts and by Correlation With the Social Security Death Index||From the date of surgery with aminolevulinic acid to the date of death, assessed up to 4 years||||months||Full Range|Median
2659979|NCT01585272|Primary|Number of Patients With Adverse Events, Serious Adverse Events, and Death|The overall rate of adverse events reported from initiation through the first 28-week treatment period|Baseline through week 28|Safety population: All enrolled subjects who received 3 mg b.i.d Exelon capsule for more than 4 weeks and used at least one dose of Exelon patch therapy.|||Participants|||Number
2659980|NCT01585246|Primary|Number of Participants With Dose Limiting Toxicities to Determine the Maximum Tolerated Dose|Dose limiting toxicities was defined as the Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher for gastrointestinal symptoms (nausea, gastritis, anorexia). The maximum tolerated dose (MTD) was established among 320mg, 640mg,or 960mg, at which less than 10% of men report less than a grade 2 of gastrointestinal symptoms.|Baseline to Week 12|Number of participants reporting adverse events at grade 2 or higher, according to the TITE-CRM algorithm|||participants|||Number
2659981|NCT01585246|Primary|Efficacy|Evaluate preliminary efficacy of Saw Palmetto at the MTD as compared to the placebo group with respect to Health-Related Quality of life (HRQOL) including physical functioning and symptoms. The outcomes were measured using 1) the International Prostate Symptoms Score (IPSS) and 2) the total and subscales of the Functional Assessment of Cancer Therapy-Prostate (FACT-P). The IPSS which ranges from 0-35. A lower score indicates better symptoms. The FACT-P has the following subscores and ranges: emotional well-being (0-24), functional well-being (0-28), physical well-being (0-28), social well-being (0-28), and prostate-specific concerns (0-48). The FACT-P total is comprised of the sum of the subscales and ranges from 0-156. For the FACT-P, a higher score indicates better quality of life. Each values was created as an average over time from a linear mixed effects model that adjusted for baseline values.|HRQOL: Baseline, week 12, 14, & 22. IPSS: Baseline, week 3-12, 14, & 22.||||units on a scale||Standard Deviation|Least Squares Mean
2659982|NCT01585246|Primary|Feasibility|Assess a Saw Palmetto supplementation protocol for feasibility by evaluation if at least 70% of eligible men consent, and if at least 70% of men enrolled at each dose complete the study.|Baseline to Week 12 for each phase.|Number of men who started|||Participants|||Count of Participants
2659983|NCT01585207|Primary|Global Severity Score on the Y-GTSS|The Global Severity score is the sum of the Total Tic score and the TD Impairment score. It is rated by the Investigator on the Yale Global Tic Severity Score ( Y-GTSS, a widely accepted measure of drug efficacy in TD. Scale from 0- 100. Higher score indicates more impairment.|weekly from baseline to end of study (10weeks)||||units on a scale||Full Range|Mean
2659984|NCT01585168|Primary|"Change in Blood Oxygenation Level Dependent (BOLD) Activation in Anterior Cingulate Cortex During Loss Condition of Monetary Incentive Delay (MID) Task Between Placebo and Study Medication"|"All participants completed the fMRI Monetary Incentive Delay task on each study day. During the task, participants needed to select the correct response during win and lose conditions by pressing a button on a button box in the MRI. Participant's BOLD activation response (A measurement of oxygen level that is released to neurons since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen to perform the tasks.) was measured while they performed the task in MRI scanner."|4 hours post intervention on each study day, separated by 1 week to 1 month|The number of subjects analyzed differs from the overall number of subjects because analyses for this measure occurred about 48 months into recruitment.|||mean of voxel wise BOLD response||Standard Deviation|Mean
2659985|NCT01585168|Secondary|Change in Impulsive Behavior as Measured on the Experimental Discounting Delay (EDT) Computerized Task Between Placebo and Study Medication|All participants completed the EDT task approximately 3 hours post drug administration on both study visits. Study days were approximately 1 week to 1 month a part. EDT is a delay-discounting task that exposes participants to choice consequences during test administration. The EDT involves multiple blocks of choices, one for each delay. Choices are made between a standard amount that is delivered immediately and is certain and a probable amount that is delayed and uncertain.|3 hours post intervention on each study day, separated by 1 week to 1 month||||responses||Standard Deviation|Mean
2659986|NCT01585168|Secondary|Change in Impulsive Behavior as Measured on the Balloon Analog Risk Task (BART) Computerized Task Between Placebo and Study Medication|"All participants completed the BART task approximately 3 hours post drug administration on both study visits. Study days were approximately 1 week to 1 month a part. BART is a computer decision-making task that measures risk taking. Participants are presented with a series of balloons. The object is to earn as much money as possible by pumping the balloon without popping it. The point of explosion varies from trial to trial and costs participants the money they have earned in that trial."|3 hours post intervention on each study day, separated by 1 week to 1 month|Participants with a family history of alcoholism (family history positive) and without a history of alcoholism (family history negative) who completed BART task.|||total pumps||Standard Deviation|Mean
2659987|NCT01585168|Primary|"Change in Blood Oxygenation Level Dependent (BOLD) Activation in the Amygdala During Win Monetary Incentive Delay (MID) Task Between Placebo and Study Medication"|"All participants completed the fMRI Monetary Incentive Delay task on each study day. During the task, participants needed to select the correct response during win and lose conditions by pressing a button on a button box in the MRI. Participant's BOLD activation response (A measurement of oxygen level that is released to neurons since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen to perform the tasks.) was measured while they performed the task in MRI scanner."|4 hours post intervention on each study day, separated by 1 week to 1 month|The number of subjects analyzed differs from the overall number of subjects because analyses for this measure occurred about 48 months into recruitment.|||mean of voxel wise BOLD response||Standard Deviation|Mean
2659988|NCT01585155|Secondary|Pediatric Ulcerative Colitis Activity Index (PUCAI) Score|PUCAI score was determined as a total of the subscores for each of the six evaluation items (0 to 85), including abdominal pain, rectal bleeding, stool consistency of most stools, number of stools per 24 hours, nocturnal stools and activity level. A higher score indicates greater disease activity.|Baseline,Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30|Five patients were discontinued. The reasons for discontinuation were adverse event in 1 patient, lack of efficacy in 2 patients, and worsening ulcerative colitis in 2 patients. Two non-responders were observed, and both of them completed the efficacy evaluation at Week 8.|||units on a scale||Standard Deviation|Mean
2668026|NCT01509677|Secondary|Change From V1 to V5 in Differential Cell Count in Induced Sputum(10^6 Eosinophils/mL)||Baseline to 14 weeks||||10^6 eosinophils/m||Standard Error|Least Squares Mean
2659989|NCT01585155|Secondary|Partial Mayo Score|Mayo score consists of four subscores (stool frequency, rectal bleeding, physician's global assessment and findings of endoscopy), each of which was assessed according to a four-level rating scale (0 to 3 points), and was determined from a total of the four subscores (0 to 12 points). In addition, the sum of the subscores (0 to 9 points) for stool frequency, rectal bleeding and physician's global assessment was used as a partial Mayo score. A higher score indicates greater disease activity.|Baseline,Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30|Five patients were discontinued. The reasons for discontinuation were adverse event in 1 patient, lack of efficacy in 2 patients, and worsening ulcerative colitis in 2 patients. Two non-responders were observed, and both of them completed the efficacy evaluation at Week 8.|||units on a scale||Standard Deviation|Mean
2659990|NCT01585155|Secondary|CAI Score|CAI score was an activity index to evaluate disease activity, which is calculated as the sum (0 to 29 points) of subscores for 7 clinical conditions, consisting of the number of stools per week, blood in stools (based on weekly average), investigator's global assessment of the symptomatic state, abdominal pain/cramps, temperature elevation due to ulcerative colitis, extraintestinal manifestations, and laboratory findings (hemoglobin or ESR). A higher score indicates greater disease activity.|Baseline,Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30|Five patients were discontinued. The reasons for discontinuation were adverse event in 1 patient, lack of efficacy in 2 patients, and worsening ulcerative colitis in 2 patients. Two non-responders were observed, and both of them completed the efficacy evaluation at Week 8.|||units on a scale||Standard Deviation|Mean
2659991|NCT01585155|Primary|Percent of Patients Who Achieved CAI Remission|"Clinical activity index (CAI) remission was defined as a case where a CAI score was not more than 4 on the evaluation day.~CAI score was an activity index to evaluate disease activity, which is calculated as the sum (0 to 29 points) of subscores for 7 clinical conditions, consisting of the number of stools per week, blood in stools (based on weekly average), investigator's global assessment of the symptomatic state, abdominal pain/cramps, temperature elevation due to ulcerative colitis, extraintestinal manifestations, and laboratory findings (hemoglobin or ESR). A higher score indicates greater disease activity."|Weeks 2, 6, 8, 10, 14, 18, 22, 26, 30, and the last time point during the period from administration of the study drug to Week 30|Five patients were discontinued. The reasons for discontinuation were adverse event in 1 patient, lack of efficacy in 2 patients, and worsening ulcerative colitis in 2 patients. Two non-responders were observed, and both of them completed the efficacy evaluation at Week 8.|||percentage of participants|||Number
2659992|NCT01585129|Secondary|Duration of Hospital Stay After Cesarean Delivery|This is the duration of hospital stay (in days) after their cesarean delivery.|Up to 7 Days||||days||95% Confidence Interval|Mean
2659993|NCT01585129|Secondary|Number of Participants With Infection-related Complications|Infection related complications will include common complications attributed to infections there are not the primary outcome (endometritis). This will include infections of the wound and pelvic abscesses.|7 days post-partum||||Participants|||Count of Participants
2659994|NCT01585129|Primary|Number of Paricipants With Endometritis|Endometritis is defined as uterine infection and is diagnosed by maternal temp > 38.0C on two occasions over a 4 hour period or any temp > 39.0C after delivery > 12 hours after delivery. Endometritis will be managed per currently accepted endometritis protocol - (Amp 2 gQ6, Gentamicin 5 mg/kg q24, Clindamycin 900 mg q8).|7 days post-partum||||Participants|||Count of Participants
2659995|NCT01585038|Secondary|Oxidative Stress Markers|Change in F2-isoprostane levels|Change from baseline to 4 weeks||||pg/mL||Standard Deviation|Mean
2659996|NCT01585038|Secondary|Endothelial Activation Markers|Change in soluble vascular cell adhesion molecule-1 levels|Change from baseline to 4 weeks||||pg/mL||Standard Deviation|Mean
2659997|NCT01585038|Secondary|Inflammatory Markers|Change in high sensitivity C-reactive protein levels|Change from baseline to 4 weeks||||mg/L||Standard Deviation|Mean
2659998|NCT01585038|Primary|Change in Flow-mediated Dilation of the Brachial Artery|This is a measure of in vivo endothelial function|Change from baseline to 4 weeks||||absolute percentage change||Standard Deviation|Mean
2659999|NCT01585025|Secondary|Change in Stool Index|"Change in index calculated on a weekly basis, between week 2 (baseline) and week 4 (week 2 of treatment).~Index calculated as ([weekly stool frequency x mean Bristol Stool Form Scale score] = Loperamide use [weekly mg x 3]).~Individual scores ranged from 25 to 1095, with higher scores being worst."|Week 2, Week 4|Missing data in Idiopathic diarrhoea controls|||index score||Inter-Quartile Range|Median
2660000|NCT01585025|Secondary|Changes in Mean Stool Form|Change in mean stool form reported per week between week 2 (baseline) and week 4 (week 2 of treatment) using the Bristol Stool Form Scale (range of scores 1 to 7). High scores are a worse outcome (7=liquid stools).|Week 2, Week 4|Missing data in Idiopathic diarrhoea controls|||Score on Bristol scale||Inter-Quartile Range|Median
2660001|NCT01585025|Secondary|Changes in Stool Frequency|Change in total number of stool episodes reported per week between week 2 (baseline) and week 4 (week 2 of treatment)|Week 2, Week 4|Missing data in Idiopathic diarrhoea controls|||stools per week||Inter-Quartile Range|Median
2660002|NCT01585025|Secondary|Changes in Serum Total Bile Acids.|Dynamic changes of total bile acids over 6 hour period following OCA administration before and after 15 day OCA period.|Day 0, Day 15||||micromol/L||Inter-Quartile Range|Median
2660003|NCT01585025|Secondary|Changes in Fasting 7α-hydroxy-4-cholesten-3-one|Change in fasting 7α-hydroxy-4-cholesten-3-one before and after 15 day administration of OCA.|Day 0, Day 15|Missing data in Primary BAD|||microgram/L||Inter-Quartile Range|Median
2660004|NCT01585025|Secondary|Changes in Non-fasting Response of FGF19 to OCA|Change in dynamic response of FGF19 in 6 hours following OCA administration; at start and end of 15 day OCA test period.|Day 0, Day 15||||percentage change||Inter-Quartile Range|Median
2660005|NCT01585025|Primary|Changes in Fasting FGF19|The primary outcome measure is the change over 2 weeks in fasting serum fibroblast growth factor (FGF19) in 3 groups of patients: primary bile acid diarrhoea, secondary bile acid diarrhoea, and a control population of patients with chronic diarrhoea but with normal bile acid retention.|Day 0, Day 15||||percentage increase of baseline||Inter-Quartile Range|Median
2661040|NCT01574157|Secondary|Change in Estimated Glomerular Filtration (eGFR)|eGFR is a measure of kidney function|The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.||||ml/min per 1.73m2||95% Confidence Interval|Mean
2660006|NCT01584843|Secondary|Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. All participants with paralytic strabismus did not receive a second injection so there were no participants to analyse for this outcome measure.|Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 Population||||||
2660007|NCT01584843|Secondary|Change From Baseline in the Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP (up to a maximum of 52 weeks of the FTP)|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population.|||Scores on a scale||Standard Deviation|Mean
2660008|NCT01584843|Secondary|Change From Baseline in the Severity of Duction Limitation at Weeks 1 and 4 of the FTP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Weeks 1 and 4 of the FTP|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population.|||Scores on a scale||Standard Deviation|Mean
2660009|NCT01584843|Secondary|Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction was limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline. All participants with paralytic strabismus did not receive a second injection so there were no participants to analyse for this outcome measure.|Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 Population||||||
2660010|NCT01584843|Secondary|Severity of Duction Limitation at Weeks 1, 4, 8, 12, 16, 20, and 24 After the Final Injection of the FTP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction is limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline.|Weeks 1, 4, 8, 12, 16, 20, and 24 after the final injection of the FTP (up to a maximum of 52 weeks of the FTP)|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population.|||Scores on a scale||Standard Deviation|Mean
2660011|NCT01584843|Secondary|Severity of Duction Limitation at Weeks 1 and 4 of the FTP|The severity of duction limitation was calculated for participants with paralytic strabismus. For each evaluable participant, assessment was done by taking a frontal photo of the condition of the affected eye to determine the maximum movement toward the direction to which duction is limited while the non-affected eye was masked with eye-patch. The evaluation was performed in the same eye (left or right) throughout the study period. Based on the photos, the severity of the duction limitation was assessed on a 6-point scale, with scores ranging from 0=no duction limitation to -5=cannot rotate eye to midline.|Week 1 and Week 4 of the FTP|FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 Population.|||Scores on a scale||Standard Deviation|Mean
2660048|NCT01584544|Primary|Number of Participants Experienced Dose Limited Toxicity|Dose related toxicity is defined as follows:1. luecopenia > grade 2; granular cell decrease > grade 2; anemia > grade 1; platelet > grade 1;SGPT/SGOT elevation > grade 1; ALP > grade 1; GGT > grade 1; Tbil > grade 1;renal function damag > grade 2;Non-gradular cell decreased fever > grade 1;nausea/vomiting > grade 1; fatigue > grade 2; weight loss > grade 2;gastritis > grade 2; dairrea > grade 2; abdominal pain > grade 2; upper gastrointestinal bleeding > grade 1;other toxic reaction > grade 2;KPS < 50 during the treatment|up to 7 weeks from start of the treatment||||participants|||Number
2660012|NCT01584843|Secondary|Duration of Effect|Duration of effect is defined as the number of days after the final injection of the FTP (after randomization in the non-treatment groups) until the date of the first recording of a value smaller than 50% in percent correction compared to the maximum change in the strabismus angle in the primary position. The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Percent correction compared to the maximum change in the strabismus angle was calculated as: (absolute angle [strabismus angle at Baseline minus the strabismus angle after injection]/absolute angle [strabismus angle at Baseline minus the strabismus angle at maximum change]) multiplied by 100.|Up to Week 48 after the final injection of the FTP (up to Study Week 52)|FAS1 Population|||Days||95% Confidence Interval|Median
2660013|NCT01584843|Secondary|Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. Percent change from Baseline in the strabismus angle was calculated as: (absolute angle [strabismus angle at Baseline minus the strabismus angle after the final injection] divided by the absolute strabismus angle at Baseline) multiplied by 100.|Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 Population|||Percent change in prism dioptre||Standard Deviation|Mean
2660014|NCT01584843|Secondary|Percent Change From Baseline in the Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for observed cases for percent change from Baseline in the strabismus angle in the primary position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in non-treatment groups; up to a maximum of 52 weeks of the FTP). Percent change from Baseline in the strabismus angle was calculated as: (absolute angle [strabismus angle at Baseline minus the strabismus angle after the final injection] divided by the absolute strabismus angle at Baseline) multiplied by|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 of the FTP|FAS1 Population|||Percent change in prism dioptre||Standard Deviation|Mean
2660015|NCT01584843|Secondary|Percent Change From Baseline in the Strabismus Angle in the Primary Position at Week 1 and Week 4 in Observed Cases (OC) of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for observed cases for the percent change from Baseline in the strabismus angle in the primary position at Week 1and Week 4 after the initial injection in the FTP. Percent change from Baseline in the strabismus angle was calculated as: absolute angle ([strabismus angle at Baseline minus strabismus angle after the final injection] divided by the absolute strabismus angle at Baseline) multiplied by 100.|Baseline and Weeks 1 and 4 of the FTP|FAS1 Population|||Percent change in prism dioptre||Standard Deviation|Mean
2660016|NCT01584843|Secondary|Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period.|Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 population.|||prism dioptre||Standard Deviation|Mean
2660017|NCT01584843|Secondary|Absolute Strabismus Angle in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The absolute values of the strabismus angle in the primary position were summarized for observed cases at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in the non-treatment groups).|Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP|FAS1 Population|||prism dioptre||Standard Deviation|Mean
2660018|NCT01584843|Secondary|Absolute Strabismus Angle in the Primary Position at Weeks 1 and 4 of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The absolute values of the strabismus angle in the primary position at Week 1 and Week 4 of the FTP were summarized for observed cases without imputation of missing values.|Weeks 1 and 4 of the FTP|FAS1 Population|||prism dioptre||Standard Deviation|Mean
2660019|NCT01584843|Secondary|Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, and 24 of the Second Treatment Period (STP)|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Weeks 1, 4, 8, 12, 16, 20, and 24 of the STP (up to Study Week 52)|FAS2 Population: all participants who were included in the FAS1 Population, received reinjection of the investigational product, and had at least one efficacy assessment after the reinjection|||prism dioptre||Standard Deviation|Mean
2660020|NCT01584843|Secondary|Change From Baseline in the Strabismus Angle PD in the Primary Position at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 After the Final Injection of the FTP|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. The values were summarized for the observed cases for the change in the strabismus angle in the primary position from Baseline at Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 (before reinjection of the second treatment period if applicable) after the final injection of the FTP (after randomization in the non-treatment groups). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 after the final injection of the FTP|FAS1 Population|||prism dioptre||Standard Deviation|Mean
2660021|NCT01584843|Secondary|Change From Baseline in the Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 1 After the Initial Injection of the FTP in Observed Cases (OC)|The strabismus angle in the primary position was measured using the APCT. The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 m) and the near-view strabismus angle (measured at a distance of 33 cm). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the value at Week 1minus the value at Baseline.|Baseline and Week 1 of the FTP|FAS1 Population|||prism dioptre||Standard Deviation|Mean
2660022|NCT01584843|Primary|Change From Baseline in Strabismus Angle Prism Dioptre (PD) in the Primary Position at Week 4 of the FTP in Observed Cases (OC)|The strabismus angle in the primary position was measured using the alternative prism cover test (APCT). The strabismus angle was evaluated as the mean value of the distant-view strabismus angle (measured at a distance of 5 meters [m]) and the near-view strabismus angle (measured at a distance of 33 centimeters [cm]). Every participant's evaluation was performed in the same affected eye (left or right) throughout the study period. Change from Baseline was calculated as the value at Week 4 minus the value at Baseline.|Baseline and Week 4 of the FTP|Full Analysis Set (FAS1) Population: all participants who were randomized and had at least one post-Baseline efficacy assessment. Values were summarized for OC of the FTP without imputation of missing values. Only those participants available at the specified time points were analyzed.|||prism dioptre||Standard Deviation|Mean
2660023|NCT01584648|Secondary|Plasma Concentrations of Dabrafenib and Its Metabolites|Blood samples were collected for PK analysis in all participants. Three blood samples were collected at Week 8: pre-dose, 1-3 hours post dose, and 4-6 hours post dose. One pre-dose blood sample was obtained at Weeks 16 and 24. Plasma concentrations of dabrafenib (GSK2118436) and its metabolites (GSK2285403, GSK2298683, and GSK2167542) were determined using the currently approved analytical methodology.|Week 8: pre-dose, 1-3 hours and 4-6 hours post dose; Week 16 pre-dose and Week 24 pre-dose|PK Population.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2660024|NCT01584648|Secondary|Plasma Concentrations of Trametinib|Blood samples were collected for Pharmacokinetic (PK) analysis in all participants. Three blood samples were collected at Week 8: pre-dose, 1-3 hours post dose, and 4-6 hours post dose. One pre-dose blood sample was obtained at Weeks 16 and 24.|Week 8: pre-dose, 1-3 hours and 4-6 hours post dose; Week 16 pre-dose and Week 24 pre-dose|Pharmacokinetic (PK) Population: all participants included in the safety population for whom a PK sample was obtained and analyzed. Only participants with data available at the specified time points were analyzed.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2660025|NCT01584648|Secondary|Number of Participants With Incidence of Squamous Cell Carcinoma|Participants were evaluated for the event of squamous cell carcinoma including Keratoacanthoma.|From Baseline up to end of study (average of 9 study months)|Safety Population|||participants|||Number
2660026|NCT01584648|Secondary|Number of Participants With Worst-case On-therapy Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Assessed by Echocardiogram|Absolute change from Baseline in LVEF were summarized at each scheduled assessment time and in the worst-case post Baseline. Only the post Baseline assessments that used the same method (ECHO or Multi Gated Acquisition Scan [MUGA]) as the Baseline assessments were used to derive the change from Baseline. The change from Baseline was categorized as any increase; no change; and any decrease and as 0-10 decrease, 10 - 19 decrease, >= 20 decrease, >=10 decrease and >= lower limit of normal (LLN), >=10 decrease and <LLN, >10 decrease and <LLN, >= 20 decrease and >= LLN, >= 20 decrease and <LLN. Only those participants with LVEF values for worst-case on-therapy are presented.|From Baseline up to Week 60|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2660027|NCT01584648|Secondary|Number of Participants With a Worse-case On-therapy Change From Baseline in the Bazett's QTc to Grade 2 or Grade 3|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. Bazett's QTc is categorized as: Grade 0 (<450 milliseconds [msec]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), and Grade 3 (>=501 msec). An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values were assumed to have a Baseline value of grade 0. Only those participants with Bazett's QTc values for worst-case on-therapy are presented.|From Baseline up to Week 60|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2660028|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline in Temperature|Change from Baseline in temperature is categorized as a decrease to <=35 degrees celsius (C), change to normal or no change as 35-38 degrees C, and increase to >=38 degrees C. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant temperature value decreased to <=35 degrees C and increased to >=38 degrees C post-Baseline. Only those participants with temperature values for worst-case on-therapy are presented.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2660049|NCT01584518|Primary|Length of Stay|The subjects will be evaluated preoperatively and followed post-operatively until discharge from the hospital. Length of stay|From date of admission until date of discharge, assessed up to 1 month||||days||Standard Deviation|Mean
2660050|NCT01584479|Secondary|Change in Evaluation for Dental Caries and Oral Cancer Within the Risk Categories||10 and 15 years|||||||
2660029|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline in Systolic and Diastolic Blood Pressure to Grade 2 or Grade 3|Change from Baseline in systolic blood pressure (SBP) is categorized as: Grade 0 (<120 millimeters of mercury [mmHg]), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), and Grade 3 (>=160 mmHg). Change from Baseline in diastolic blood pressure (DBP) is categorized as: Grade 0 (<80 mmHg), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), and Grade 3 (>=100 mmHg). An increase is defined as an increase in the CTCAE grade relative to the Baseline grade. Participants with missing Baseline values were assumed to have a Baseline value of grade 0. Only those participants with blood pressure values for worst-case on-therapy are presented.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2660030|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline in Heart Rate|Change from Baseline in heart rate is categorized as decrease to <60 beats per minute (bpm), change to normal or no change, and increase to >100 bpm. Participants with a missing Baseline value are assumed to have a normal Baseline value. Participants were counted twice if the participant heart rate value decreased to <60 bpm and increased to >100 bpm post-Baseline. Only those participants with heart rate values for worst-case on-therapy are presented.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2660031|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline With Respect to the Normal Range for the Indicated Clinical Chemistry Parameters|Clinical chemistry tests where the toxicity grade is not defined by NCI-CTCAE includes chloride, creatinine clearence, lactate dehydrogenase, urea, protein and carbon dioxide. Change from Baseline is categorized as decrease to low, change to normal or no change, increase to high in reference to the normal range. Only those participants with laboratory values for worst-case on-therapy are presented. For the worst-case on-therapy, participants were counted twice if the participant lab value decreased to low and increased to high during the on-therapy period.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
2660032|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Change From Baseline With Respect to the Normal Range for the Indicated Hematology Parameters|Hematology tests where the toxicity grade is not defined by NCI-CTCAE includes basophils, eosinophils and monocytes. Change from Baseline is categorized as a decrease to low, change to normal or no change, increase to high in reference to the normal range. Only those participants with laboratory values for worst-case on-therapy are presented. For the worst-case on-therapy, participants were counted twice if the participant lab value decreased to low and increased to high during the on-therapy period.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
2660033|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Grade Change From Baseline to Grade 3 and 4 for the Indicated Hematology Parameters|Hematology data were summarized according to NCI-CTCAE grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe, or disabling; Grade 4, Life-threatening; Grade 5, Death related to AE. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Hematology tests where the toxicity grade is defined by NCI-CTCAE includes hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. Only those participants with laboratory values for worst-case on-therapy are presented. Worst-case on-therapy included both scheduled and unscheduled visits.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
2660034|NCT01584648|Secondary|Number of Participants With a Worst-case On-therapy Grade Change From Baseline to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters|Clinical chemistry data were summarized according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade, version 4.0. Grade 1, Mild; Grade 2, Moderate; Grade 3, Severe or disabling; Grade 4, Life-threatening; Grade 5, Death related to AE. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred. Clinical chemistry tests where the toxicity grade is defined by NCI-CTCAE includes albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, calcium, glucose, potassium, sodium, creatinine and phosphate. Participants with missing Baseline grades were assumed to have a Baseline grade of 0. Only those participants with laboratory values for worst-case on-therapy are presented. Worst-case on-therapy included both scheduled and unscheduled visits.|From Baseline up to Week 64|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population.|||Participants|||Number
2660051|NCT01584479|Secondary|Change in Relationship of Risk Category & Tooth Loss Rate With Systemic Disease History on Questionnaire.||10 and 15 years|||||||
2660052|NCT01584479|Secondary|Change in Periodontal Surgery Claims||10 and 15 years|||||||
2660053|NCT01584479|Secondary|Change in Total Periodontal Claims During the Monitoring Period||10 and 15 years|||||||
2660054|NCT01584479|Secondary|Change in Total Dental Claims During Monitoring Period||10 and 15 years|||||||
2660055|NCT01584479|Primary|Percentage of Participants With Tooth Loss Over 16 Year Period|Tooth loss rate over 16 years was calculated as the cumulative percentage of participants with tooth loss over 16 years.|16 years||||percentage of participants|||Number
2660056|NCT01584388|Secondary|Time to Complete Remission|Treatment phase up to 52 weeks (365 days)|Days||||Days||Standard Deviation|Mean
2660057|NCT01584388|Secondary|Time to Relapse|Treatment phase up to 52 weeks (365 days)|Days||||Days||Standard Deviation|Mean
2660058|NCT01584388|Secondary|Time to Disease Response|Treatment phase up to 52 weeks (365 days)|Mean days +/- standard deviation||||Days||Standard Deviation|Mean
2660035|NCT01584648|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a par., temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Protocol specific SAEs included: ALT≥3XULN and total bilirubin ≥2XULN (35% direct) or ALT ≥3XULN and INR >1.5 (if INR is measured); any new malignancy with a histology different from the primary tumor; left ventricular ejection fraction that met stopping criteria; central serous retinopathy or retinal vein occlusion; pyrexia accompanied by ≥grade 3 hypotension, or hypotension that is clinically significant as judged by the investigator, dehydration requiring IV fluids, or severe rigor/chills. Refer to the general AE/SAE module for a list of AEs and SAEs.|From the time the first dose of study treatment administered until 30 days after discontinuation of study treatment (average of 9 study months)|Safety Population: all randomized participants who received at least one dose of study medication and were based on the actual treatment received if this differed from that to which the participant was randomized.|||Participants|||Number
2660036|NCT01584648|Secondary|Duration of Response for Participants With a Confirmed Response (Complete Response or Partial Response)|Duration of response is defined as the time (in months) from the first documented complete response (CR: the disappearance of all target lesions and any pathological lymph nodes must have a short axis of <10 mm and the disappearance of all non-target lesions) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm) until disease progression (PD). PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5mm or the appearance of one or more new lesions, or the worsening of non target lesions significant enough to require study treatment discontinuation. PD was based on the radiological evidence by investigator.|From the time of the first documented response (CR or PR) until disease progression (average of 9 study months)|ITT population. Only those participants with a confirmed CR or PR were analyzed (with or without measurabe disease at Baseline).|||Months||95% Confidence Interval|Median
2660037|NCT01584648|Secondary|Number of Participants With a Confirmed Response (Complete Response or Partial Response)|A participant was defined as a responder if he/she sustained a complete response (CR: the disappearance of all target lesions and any pathological lymph nodes must have a short axis of <10 mm and the disappearance of all non-target lesions) or partial response (PR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters or the persistence of 1 or more non-target lesions or lymph nodes identified as a site of disease at Baseline with a short axis of ≥10mm).|From randomization until the first documented complete response or partial response (average of 9 study months)|ITT Population. Only participants with measurable disease at Baseline per RECIST were analyzed.|||Participants|||Number
2660038|NCT01584648|Secondary|Overall Survival (OS)|OS is defined as the interval of time (in months) between the date of randomization and the date of death due to any cause. For participants who did not die, time of death was censored at the date of last contact.|From randomization until death due to any cause (average of 9 study months)|ITT Population|||Months||95% Confidence Interval|Median
2660039|NCT01584648|Primary|Progression-Free Survival (PFS) as Assessed by the Investigator|Progression-free survival (PFS) is defined as the time (in months) from the date of randomization to the first documented occurrence of PD or death. Investigator PFS was summarized per response evaluation criteria in solid tumors (RECIST, version 1.1) which is a set of published criteria defining when cancer patients improve (respond), stay the same (stable) or worsen (progress). PD is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5mm or the appearance of one or more new lesions, or the worsening of non target lesions significant enough to require study treatment discontinuation. For participants who had not progressed or died at the time of the analysis, censoring was performed at the last adequate disease assessment.|From randomization until the earliest date of disease progression (PD) or death due to any cause (average of 9 study months)|Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not they received the study treatment. Any participant who received a treatment randomization number was considered to have been randomized.|||Months||95% Confidence Interval|Median
2660040|NCT01584609|Secondary|Good Neurological Outcome at 90 Days|Defined by an mRS score of 0-2, or equal to the pre-stroke mRS score if the pre-stroke mRS score was higher than 2, or an improvement of 10 or more points on the NIHSS score|At 90 days post-procedure||||Participants|||Count of Participants
2660041|NCT01584609|Secondary|Number of Symptomatic Intracranial Hemorrhage||Within 24 hours post-procedure||||Symptomatic Intracranial Hemorrhage|||Number
2660042|NCT01584609|Secondary|All Cause Mortality||At 90 days post-procedure||||Participants|||Count of Participants
2660043|NCT01584609|Secondary|Number of Participants With 90 Day mRS Score 0-2||at 90 days post-procedure||||Participants|||Count of Participants
2660044|NCT01584609|Secondary|Good Clinical Outcome at 30 Days|Defined by a 10 points or more improvement in the NIHSS at Discharge, a NIHSS score of 0-1 at Discharge; or a 30-day mRS score of 0-2. The NIHSS is a stroke scale that measures impairment caused by stroke. The Modified Rankin scale (mRS) measures neurological disability or dependence for stroke patients.|30 days post-procedure|Analysis population demonstrate outcomes of number of subjects that met endpoint.|||Participants|||Count of Participants
2660045|NCT01584609|Primary|Number of Procedure-related Serious Adverse Event||Within 24 hours post-procedure||||Procedure-related Serious Adverse Events|||Number
2660046|NCT01584609|Primary|Number of Device-related Serious Adverse Events||Within 24 hours post-procedure||||Device-Related Serious Adverse Events|||Number
2660047|NCT01584609|Primary|Number of Participants With Angiographic Revascularization of the Occluded Target Vessel|Number of Participants with Angiographic revascularization of the occluded target vessel defined by mTICI grade 2-3|At immediate post-procedure|Analysis population demonstrate outcomes of number of subjects that met endpoint.|||Participants|||Count of Participants
2660059|NCT01584388|Secondary|Complete Remission (Any Timepoint), Exclusive of Serum IgG4|IgG4-RD RI = 0 (exclusive of serum IgG4) at any point in the trial|12 months||||Participants|||Count of Participants
2660066|NCT01584388|Primary|No Disease Flares During Rituximab Treatment Phase|"Disease flare measured by responder Index score:~At each assessment, the physician enters a 0-4 score after the organ/site listed with:~0 = Normal or resolved~= Improved but still present~= Persistent (still active; unchanged from previous visit)~= New or recurrent disease activity while patient is off treatment~= Worsened or new disease despite treatment Definitions Organ/Site score: The overall level of IgG4-RD activity within a specific organ system Symptomatic: Is the disease manifestation in a particular organ system symptomatic? (Y = yes; N = no) Urgent disease: Disease that requires treatment immediately to prevent serious organ dysfunction (Y = yes; N = no) (Presence of urgent disease within an organ leads to DOUBLING of that organ system score) Damage: Organ dysfunction that has occurred as a result of IgG4-RD and is considered permanent (Y = yes; N = no)"|Month 6|number of subjects without disease flares during baseline to 6 month of treatment|||Participants|||Count of Participants
2660067|NCT01584388|Primary|Cumulative Glucocorticoid Use at Baseline and 6 Months|Cumulative glucocorticoid therapy between baseline and 6 months.|6 months|cumulative glucocorticoid use at 6 and compare them to baseline using paired T tests.|||mg||Full Range|Mean
2660068|NCT01584388|Primary|IgG4-RD RI Score at Baseline and Six Months After Rituxan Treatment|"The IgG4-RD RI is then calculated by adding the individual organ scores.At each assessment, the physician enters a 0-4 score after the organ/site listed with:~0 = Normal or resolved~= Improved but still present~= Persistent (still active; unchanged from previous visit)~= New or recurrent disease activity while patient is off treatment~= Worsened or new disease despite treatment Definitions Organ/Site score: The overall level of IgG4-RD activity within a specific organ system Symptomatic: Is the disease manifestation in a particular organ system symptomatic? (Y = yes; N = no) Urgent disease: Disease that requires treatment immediately to prevent serious organ dysfunction (Y = yes; N = no) (Presence of urgent disease within an organ leads to DOUBLING of that organ system score) Damage: Organ dysfunction that has occurred as a result of IgG4-RD and is considered permanent (Y = yes; N = no)~The Responder Index ranges from 0-60."|6 months||||units on a scale||Standard Deviation|Mean
2660069|NCT01584232|Secondary|Percentage of Participants With Hypoglycemic Episodes|The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least one hypoglycemic episode over the 26-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 Weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine. Only pre-rescue data was used.|||percentage of participants|||Number
2660070|NCT01584232|Secondary|Change From Baseline in Body Weight at 26 Weeks|Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline body weight as a covariate, and participant as a random effect.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable body weight data. Only pre-rescue measurements were used.|||kilograms (kg)||Standard Error|Least Squares Mean
2660071|NCT01584232|Secondary|Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks|Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal, at bedtime, and before breakfast the next morning (second pre-morning meal). Least squares (LS) means were calculated using analysis of covariance (ANCOVA) model with treatment, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects and baseline SMBG as a covariate.|Baseline, Up to 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable SMBG data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), using only postbaseline data.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2660072|NCT01584232|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks|Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline FBG as a covariate, and participant as a random effect.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable fasting blood glucose data. Only pre-rescue measurements were used.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2660073|NCT01584232|Secondary|Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a longitudinal logistic regression model with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.|Up to 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable HbA1c data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), using only postbaseline data.|||percentage of participants|||Number
2660074|NCT01584232|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks|Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, oral antihyperglycemic medication regimen (sulfonylureas only, biguanides only, or both), and baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.|Baseline, 26 weeks|Participants who were randomized and received at least 1 dose of LY2189265 or insulin glargine with evaluable HbA1c data. Only pre-rescue measurements were used.|||percentage of HbA1c||Standard Error|Least Squares Mean
2660075|NCT01584024|Secondary|Number of Lesions With Progression as Measured by Depth Category (N=Lesions)|Radiographic lesion depth categories: E2 (inner enamel), D1 (outer dentin) and D2-rest (middle dentin or restored). Lesion depth assessment on single radiograph (baseline, 3 yr).|3 Years||||Lesions|Lesions||Count of Units
2660076|NCT01584024|Primary|Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions)|Cumulative lesion progression as measured by PW comparison of radiographs (baseline versus 3 year)|3 Years||||Lesions|Lesions||Count of Units
2660077|NCT01583985|Secondary|Hospitalizations|All cause, EMR-confirmed hospitalizations|12 months|All randomized participants|||Participants|||Count of Participants
2660078|NCT01583985|Secondary|Falls|Number of falls in 12 months after enrollment|12 months|Patients reporting falls at any outcome timepoint|||Participants|||Count of Participants
2660079|NCT01583985|Secondary|Medication-related Symptom Checklist|Checklist of bothersome medication-related symptoms (0-19, higher number = more symptoms)|3 months, 6 months, 9 months, and 12 months|those with any follow-up outcomes|||symptoms||Standard Deviation|Mean
2660080|NCT01583985|Secondary|Brief Pain Inventory Severity Scale|Measure of pain intensity (range 0-10; higher score is worse)|3 months, 6 months, 9 months, and 12 months|patients with at least one follow-up assessment|||units on a scale||Standard Deviation|Mean
2660081|NCT01583985|Primary|Brief Pain Inventory Interference Scale|Measure of pain-related functional interference (range 0-10; higher score is worse)|3 months, 6 months, 9 months, and 12 months|Patients with at least one follow-up outcome assessment|||units on a scale||Standard Deviation|Mean
2660082|NCT01583894|Primary|Multi-site Pain Index|"Multiple Site Pain Index (MSPI) was developed by collating multiple pain descriptors into a single index. Pain descriptors used for developing this index were percent body area in pain, number of painful areas, span of painful areas, and Regional Pain Ratings (RPRs) which includes data on pain severity and pain continuity for 47 body regions.~MSPI score ranged from 0 to 1; 0 representing no pain and 1 representing extreme continuous pain over entire body, except the head and face regions."|single-visit|MSPI was calculated using multiple pain descriptors which were obtained from pain drawings. 810 of the 813 patients that completed the study provided complete pain drawing data, and so MSPI could be calculated only in 810 patients.|||units on a scale||Standard Deviation|Mean
2660083|NCT01583686|Primary|Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.||||Participants|||Count of Participants
2660084|NCT01583686|Primary|Number of Patients With Objective Tumor Regression|Objective tumor regression response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.0. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|3.5 mos.||||Participants|||Count of Participants
2660085|NCT01583647|Primary|Plasma Cmax of Nicotinuric Acid (NUA)||Predose on Day 1 up to 48 hours postdose|The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.||||||
2660086|NCT01583647|Primary|Total Urinary Excretion of Niacin and Niacin Metabolites||Predose on Day 1 up to 72 hours postdose|The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.||||||
2660087|NCT01583647|Primary|Plasma Maximum Concentration (Cmax) of Laropiprant||Predose on Day 1 up to 48 hours postdose|The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.||||||
2660088|NCT01583647|Primary|Plasma Area Under the Concentration Curve From 0 to Infinity (AUC0-∞) of Laropiprant||Predose Day 1 up to 24 hours postdose|The study was terminated during Panel A and the decision was made to not analyze the blood and urine pharmacokinetic samples collected during Panel A; Panel B was not conducted.||||||
2660089|NCT01583543|Secondary|Number of Participants Experiencing a Grade 3 or 4 Clinically Significant and Related Adverse Event|Adverse events were graded according to CTCAE v.4 (Common Terminology Criteria for Adverse Events). Events are graded on a scale of 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = fatal. Only events that are clinically significant and which the treating investigator considers to be related to administration of olaparib are counted for this outcome measure.|2 years||||Participants|||Count of Participants
2660090|NCT01583543|Secondary|Overall Survival|Number of patients survived for 2 years after enrolling onto this study.|Two years||||Participants|||Count of Participants
2660091|NCT01583543|Secondary|Progression-Free Survival|Number of patients with progression free survival after two years from starting the trial.|Two years||||Participants|||Count of Participants
2660092|NCT01583543|Primary|Objective Response Rate of Olaparib|"Number of participants with objective response rate as defined as PR+CR as determined by RECIST vs. 1.1.~Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|2 years||||Participants|||Count of Participants
2660732|NCT01576783|Other Pre-specified|Long-term Efficacy in Improving Cognition|Long-term (26-32 months of age) cognitive outcome. This will be evaluated based on scores from the cognitive section of the Developmental Profile - 3.|Long-term effect (6 months +) after intervention completion|||||||
2660093|NCT01583530|Secondary|Number of Participants Who Experienced Adverse Events|Includes AEs reported in participants from the first dose of belimumab throughout the study through Day 70/Exit (single dose groups) or Day 119/Exit (multiple dose groups).|Up to Day 119|Analyses were performed on the as-treated population, defined as the set of all participants who received at least 1 partial or full dose of treatment with the assignment to treatment group that was based on the actual treatment administered to the participants.|||participants|||Number
2660094|NCT01583530|Secondary|Absolute Bioavailability of Weekly (x 4) SC Injections of Belimumab|Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability following weekly (x 4) SC injections of belimumab was calculated by comparing the bioavailability of belimumab administered IV to the bioavailability of belimumab administered via 4 weekly SC injections.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||percentage bioavailability||90% Confidence Interval|Mean
2660095|NCT01583530|Secondary|Terminal Elimination Half-life (t1/2,Term) Following Weekly (x 4) SC Injections of Belimumab|Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||days||Standard Deviation|Mean
2660096|NCT01583530|Secondary|Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following Weekly (x 4) SC Injections of Belimumab|AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||µg∙day/mL||Geometric Coefficient of Variation|Geometric Mean
2660097|NCT01583530|Secondary|Maximum Serum Drug Concentration (Cmax) Following Weekly (x 4) SC Injections of Belimumab||Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2660098|NCT01583530|Primary|Absolute Bioavailability of a Single Dose of Belimumab Given as IV or SC|Bioavailability (F) is a measurement of the rate and extent to which a drug reaches the systemic circulation. The bioavailability of belimumab administered by IV is compared to the bioavailability of belimumab administered via single-SC injection.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||percentage bioavailability||90% Confidence Interval|Mean
2660099|NCT01583530|Primary|Terminal Elimination Half-life (t1/2,Term) Following a Single Dose of Belimumab Given as IV or SC|Terminal elimination half-life is the time measured for the serum drug concentration of belimumab to decrease by one half.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||days||Standard Deviation|Mean
2660100|NCT01583530|Primary|Area Under the Serum Drug Concentration-time Curve From Time 0 to Infinite Time (AUC0-∞) Following a Single Dose of Belimumab Given as IV or SC|AUC (0-∞) = Area under the serum drug concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-last) plus C (last)/λz. C (last) is the last measurable concentration. λz was determined by linear regression (r2 ≥ 0.8) with uniform weighting of all data in the terminal linear portion of the log-transformed drug concentration-time profile.|Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||µg∙day/mL||Geometric Coefficient of Variation|Geometric Mean
2660101|NCT01583530|Primary|Maximum Serum Drug Concentration (Cmax) Following a Single Dose of Belimumab Given as IV or SC||Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2660102|NCT01583530|Secondary|Time to Reach Maximum Serum Drug Concentration (Tmax) Following Weekly (x 4) SC Injections of Belimumab||Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 22, 23, 24, 25, 26, 27, 28, 31, 35, 42, 49, 63, 77, 91, and 119|The pharmacokinetic parameter analysis set included all participants who had received 4 weekly doses of belimumab and had serum concentration data available through 7 weeks from first dose. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||days||Standard Deviation|Mean
2668027|NCT01509677|Secondary|Change From V1 to V5 in Differential Cell Count in Induced Sputum(10^6 Macrophages/mL)||Baseline to 14 weeks||||10^6 macrophages/mL||Standard Error|Least Squares Mean
2660103|NCT01583530|Primary|Time to Reach Maximum Serum Drug Concentration (Tmax) Following a Single Dose of Belimumab Given as Intravenous Infusion (IV) or Subcutaneous Injection (SC)||Pre-dose, Post-dose on Days 0, 1, 2, 3, 4, 5, 6, 7, 10, 14, 21, 28, 42, 56, and 70|The pharmacokinetic parameter analysis set included all participants who had received at least 1 dose of belimumab and had serum concentration data available through the Day 28 visit. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||days||Full Range|Median
2660104|NCT01583452|Secondary|Time to Tolerate Feedings (Oral Intake)|The time between the end of surgery to the moment in which the patient can tolerate the intake of fluids or any type of food.|End of surgery to oral intake tolerance (from 1 to 3 days)|Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.|||hours||Standard Deviation|Mean
2660105|NCT01583452|Secondary|Time to First Bowel Movement|The time between the end of surgery and the moment in which the patient presents first bowel movement.|End of surgery to first bowel motion (from 1 to 7 days)|Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.|||hours||Standard Deviation|Mean
2660106|NCT01583452|Secondary|Time to First Flatus|The time between the end of surgery and the moment in which the patient passes first flatus|End of surgery to first flatus (from 1 to 3 days)|Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.|||hours||Standard Deviation|Mean
2660107|NCT01583452|Primary|Post-Operative Hospital Stay|The time between the end of surgery and hospital discharge, measured in hours|End of surgery to hospital discharge (from 4 to 7 days)|Patients who underwent open or laparoscopic appendectomy and received chewing gum plus standard pharmacologic care, or just pharmacologic care (control group), as a measure to prevent post-operative ileus.|||hours||Standard Deviation|Mean
2660108|NCT01583374|Secondary|Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period|A TEAE was an adverse event (AE) with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. A serious AE = results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; or constitutes an important medical event. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = symptoms causing severe pain discomfort.|Week 0 to week 260; overall mean duration of exposure to apremilast 20 mg and 30 mg BID was 160.96 weeks|Apremilast Subjects as Treated (AAT) were those who received at least 1 dose of apremilast at any time during the study. Participants were included in the treatment group corresponding to the apremilast dosing regimen they actually received, irrespective of the treatment group to which they were randomized or re-randomized.|||Participants|||Count of Participants
2660109|NCT01583374|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase|A TEAE was an adverse event (AE) with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. A serious AE = results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; or constitutes an important medical event. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = symptoms causing severe pain discomfort.|From Week 0 to Week 24; the median duration of exposure was 23.57 weeks for the placebo arm, 23.71 weeks for the apremilast 20 mg arm and 24.00 weeks for the apremilast 30 mg arm.|Safety population includes all participants who were randomized and received at least one dose of IP. Includes data through Week 16 for placebo-treated and apremilast 20 mg BID treated participants who escaped early and data up to Week 24 for all other participants.|||Participants|||Count of Participants
2660110|NCT01583374|Secondary|Change From Baseline in the Radiographic Score Using the Modified Stoke Ankylosing Spondylitis Spine Score (m-SASSS) at Week 104 and Week 260|"The Modified Stoke Ankylosing Spondylitis Spine Score is a scoring method used to determine the amount or degree of ankylosing spondylitis disease that is in the spine based on x-ray radiographs of the spine. The m-SASSS scores 0-3.~0 = No abnormality, 1 = Erosion, Sclerosis or Squaring, 2 = Syndesmophyte, 3 = Total bony Bridging at each Site. An increase in the m-SASSS indicated a worsening of AS disease."|Baseline to Week 104 and 260|The radiograph subset analysis population included randomized participants who received at least one dose of IP and had at least a baseline radiograph available. Includes apremilast participants as treated who had a baseline and at least one post-baseline score. Missing scores were imputed using the LOCF.|||Units on a Scale||Standard Deviation|Mean
2660111|NCT01583374|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Metrology Index-Linear (BASMI-Linear) at Week 24|The BASMI-Linear was designed to assess axial status (ie, cervical, dorsal and lumbar spine, hips, and pelvic soft tissue) and to define clinically significant changes in spinal movement. Five dimensions of movement (lateral lumbar flexion, tragus to wall, forward lumbar flexion, maximal intermalleolar distance, and cervical rotation) were measured and normalized on 0 to 10 unit NRS. The average of these scores was the total BASMI score, ranging from 0-10 with higher values indicating more severe limitation in spinal mobility.|Baseline and Week 24|The mITT population included those who were randomized and received at least one dose of IP. Missing data were imputed as baseline carried forward for participants who escaped early or discontinued early (prior to Week 24) due to lack of efficacy and LOCF for other early discontinuations|||Units on a Scale||Standard Error|Least Squares Mean
2660128|NCT01583166|Secondary|Post-operative Pain Scale at 6-7 Hours Post op|Visual analog score at 6 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain)|6-7 hours|Study team failed to obtain 6-7 hour pain score for 24 out of the 80 participants. The overall number of participants analyzed reflects this occurence.|||units on a scale||Standard Deviation|Mean
2668028|NCT01509677|Secondary|Change From V1 to V5 in Differential Cell Count in Induced Sputum(10^6 Neutrophils/mL)||Baseline to 14 weeks||||10^6 neutrophils/mL||Standard Error|Least Squares Mean
2660112|NCT01583374|Secondary|Change From Baseline in the Physical Component Summary Score (PCS) of Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) at Week 24|The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) was a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores (based on US general population with mean of 50 and standard deviation of 10) were used in analyses. Higher scores indicate a higher level of functioning. The PCS encompasses physical functioning, role-physical, and bodily pain, as well as general health and vitality. A positive change from baseline score indicates an improvement|Baseline and Week 24|The mITT included those who were randomized and received at least one dose of IP. Missing data were imputed as baseline carried forward for participants who escaped early or discontinued early (prior to Week 24) due to lack of efficacy and LOCF for other early discontinuations.|||Units on a Scale||Standard Error|Least Squares Mean
2660113|NCT01583374|Secondary|Change From Baseline in the Ankylosing Spondylitis Quality of Life (ASQoL) Summary Score at Week 24|The ASQoL is a validated disease specific patient reported outcomes instrument to assess the impact of ankylosing spondylitis on the quality of life of individuals with emphasis on the ability of the person to fulfill his or her needs. It consisted of 18 items requesting a yes (score=1) or no (score=0) response to questions related to the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. The summary score ranges 0-18 with higher scores indicating worse quality of life.|Baseline and Week 24|The mITT included those who were randomized and received at least one dose of IP. Missing data were imputed as baseline carried forward for participants who escaped early or discontinued early (prior to Week 24) due to lack of efficacy and LOCF for other early discontinuations.|||Units on a Scale||Standard Error|Least Squares Mean
2660114|NCT01583374|Secondary|Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS) Response at Week 24|"ASAS 20 was defined as achieving an improvement from baseline of ≥ 20% and ≥ 1 unit in at least 3 of 4 ASAS domains on a scale of 0 to 10 units and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains are:~Patient Global Assessment of Disease (0 - 10 unit Numerical Rating Scale [NRS]); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = not active and the right-hand box = very active~Total Back Pain (0 to 10 unit NRS); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = no pain and the right-hand box = most severe pain~Function (Bath AS Functional Index [BASFI] NRS 0 - 10 unit); participant provides a self-administered survey of 10 questions assessing for degree of mobility and functional ability~Inflammation domain is determined by the mean of 2 Bath AS Disease Activity Index NRS Questions #5 and #6 for morning stiffness) (0 - 10 unit)"|Baseline and Week 24|The mITT population included participants who were randomized and received at least one dose of investigation product (IP). Participants who discontinued early due to lack of efficacy were counted as nonresponders, and last observation carried forward (LOCF) imputation was used for participants who discontinued for other reasons.|||Percentage of Participants|||Number
2660115|NCT01583374|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24|The BASDAI is a composite score based on a participant self-administered survey of six questions measured using a 0 to 10 unit numerical rating scale (NRS) that assessed the participants' five major symptoms of AS: 1) fatigue; 2) spinal pain; 3) peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. The participant was asked to mark the box with an X on a 0 to 10 unit NRS for each of the 6 questions. To give each of the five symptoms equal weighting, the mean of the two scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score of 4 or greater was considered to be indicative of active AS disease.|Baseline and Week 24|The mITT population included those who were randomized and received at least one dose of IP. Missing data were imputed as baseline carried forward for participants who escaped early or discontinued early (prior to Week 24) due to lack of efficacy and LOCF for other early discontinuations.|||Units on a Scale||Standard Error|Least Squares Mean
2660116|NCT01583374|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24|The BASFI is a composite score based on a self-administered survey of 10 questions using a 0 to 10 unit numerical rating scale (NRS) that assesses the degree of mobility and functional ability. The survey consists of 8 questions regarding function in AS and the last 2 reflect the ability to manage everyday life. The patient marks a box with an X on a 0 to 10 unit NRS for 10 questions; the left-hand box of 0 = easy; the right-hand box = impossible. The resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. The overall score is the mean of the 10 items and ranges from 0 to 10. A higher score correlates to reduced functional ability.|Baseline and Week 24|The mITT population included those who were randomized and received at least one dose of IP. Missing data were imputed as baseline carried forward for participants who escaped early or discontinued early (prior to Week 24) due to lack of efficacy and LOCF for other early discontinuations|||Units on a Scale||Standard Error|Least Squares Mean
2660117|NCT01583374|Primary|Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) Response at Week 16|"ASAS 20 was defined as achieving an improvement from baseline of ≥ 20% and ≥ 1 unit in at least 3 of 4 ASAS domains on a scale of 0 to 10 units and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains are:~Patient Global Assessment of Disease (0 - 10 unit Numerical Rating Scale [NRS]); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = not active and the right-hand box = very active~Total Back Pain (0 to 10 unit NRS); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = no pain and the right-hand box = most severe pain~Function (Bath AS Functional Index [BASFI] NRS 0 - 10 unit); participant provides a self-administered survey of 10 questions assessing for degree of mobility and functional ability~Inflammation domain is determined by the mean of 2 Bath AS Disease Activity Index NRS Questions #5 and #6 for morning stiffness) (0 - 10 unit)"|Baseline and Week 16|The mITT population included participants who were randomized and received at least one dose of investigation product (IP). Participants who discontinued early due to lack of efficacy were counted as nonresponders, and last observation carried forward (LOCF) imputation was used for participants who discontinued for other reasons.|||Percentage of Participants|||Number
2660118|NCT01583218|Secondary|mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3|mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).|mITT: Between randomization and Day 42 (max)|The mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components.|||Percentage of Participants||95% Confidence Interval|Number
2660119|NCT01583218|Secondary|mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3|mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).|mITT Cohort 2: Between randomization and Day 42 (max)|"Cohort 2 (encompasses both participants over 75 and participants with baseline D-dimer ≥ 2 x ULN as determined by the local lab) of the mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components."|||Percentage of Participants||95% Confidence Interval|Number
2660120|NCT01583218|Secondary|mITT Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3|mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).|mITT Cohort 1: Between randomization and Day 42 (max)|Cohort 1 (participants with baseline D-dimer ≥ 2 x ULN as determined by the local lab) of the mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components.|||Percentage of Participants||95% Confidence Interval|Number
2660121|NCT01583218|Primary|Percentage of Participants Experiencing Major Bleeding Through Seven Days After Discontinuation of All Study Medication|Percentage of participants experiencing at least one major bleeding adjudicated by a blinded independent CEC between randomization (day 1) and up to seven days after discontinuation of all study medication.|Between randomization and Day 49 (max)|Safety population which consisted of all participants who had taken at least one dose of study drug.|||Percentage of Participants||95% Confidence Interval|Number
2660122|NCT01583218|Primary|mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3|mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).|mITT: Between randomization and Day 47 (max)|The mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components.|||Percentage of Participants||95% Confidence Interval|Number
2660123|NCT01583218|Primary|mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3|mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).|mITT Cohort 2: Between randomization and Day 47 (max)|"Cohort 2 (encompasses both participants over 75 and participants with baseline D-dimer ≥ 2 x ULN as determined by the local lab) of the mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components."|||Percentage of Participants||95% Confidence Interval|Number
2660124|NCT01583218|Primary|Modified Intent-to-Treat (mITT) Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic Deep Vein Thrombosis (DVT), Non-fatal Pulmonary Emboli (PE), VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3|mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, venous thromboembolism (VTE) related death adjudicated by a blinded independent Clinical Events Committee (CEC) between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).|mITT Cohort 1: Between randomization and Day 47 (max)|Cohort 1 (participants with baseline D-dimer ≥ 2 x upper limit normal (ULN) as determined by the local lab) of the mITT population which consisted of all participants who had taken at least one dose of study drug and who had follow-up assessment data on one or more primary or secondary efficacy components.|||Percentage of Participants||95% Confidence Interval|Number
2660125|NCT01583179|Secondary|Pain Score on Post Operative Day 1|pain score on post operative day 1 was measured on a scale 1-10. higher scores correlates with more severe pain. score range is from '0' (no pain) to 10 (pain as severe as it can be)|1 day postoperative|The study was closed prematurely due to low enrollment and anticipation of future barriers in enrollment|||score on a scale||Inter-Quartile Range|Median
2660126|NCT01583179|Primary|Time Until First Pain Medication Post-operatively|Time in minutes until first pain medication was take by participant post-operatively|48 hrs|The study was closed prematurely due to low enrollment and anticipation of future barriers in enrollment.The Overall Number of Participants Analyzed represents the Number of Participants with evaluable data.|||Time in minutes||Standard Deviation|Mean
2660127|NCT01583166|Secondary|Visual Analog Scale for Pain: Pre-operative.|Participants asked to report on pre-operative level of pain using a Visual Analog Scale. The scale is participant reported and ranges from 0 representing no pain to 10 representing unbearable pain.|At enrollment|Please noticed that there is a discrepancy with the number of subjects. We include the data from all subjects who were randomized and had the intervention.|||Reported Pain Level score on VAS||Standard Deviation|Mean
2660129|NCT01583166|Secondary|Post-operative Pain Scores at 2-3 Hours Post op|Visual analog score at 2 hours post op will be compared in the two groups. The scale ranges from 0 (no pain) to a maximum of 10 (unbearable pain)|2-3 hours|Please notice that the number of subjects is different because we only analyzed the pain scores from the subjects who were randomized and had the surgery. We also had some missing pain scores|||units on a scale||Standard Deviation|Mean
2660130|NCT01583166|Primary|Number of Subjects Who Passed the Voiding Trial After a Midurethral Sling|Study team assessment of whether the use of local anesthetic has any affect on the percentage of patients who pass their post-operative bladder challenge. This is determined by their voided volume and post-void residual.|2 weeks|Passed void trial|||Participants|||Count of Participants
2660131|NCT01583101|Primary|The Number of Prompts That Were Responded to|The main outcome of interest is whether or not a prompt was answered (discussed/not discussed).|1 year||||Participants|||Count of Participants
2660132|NCT01582971|Primary|Use of Unscheduled Health Service|Measured by Conventional Health Service and Productivity Costs to assess the number of unscheduled times the patient visits an emergency room, urgent care center, and hospitalization.|Week 11|Participant outcome data collected at week 11|||unscheduled visits||Standard Deviation|Mean
2660133|NCT01582971|Primary|Quality of Life Index (QLI)|The QLI assesses perceived quality of life including health and functioning domain, psychological/spiritual domain, social and economic domain, and family domain. The QLI consists of two sections: one measures respondent's satisfaction with the various domain of life and the other measures the importance of those domains. The satisfaction scores are centered and weighed by the importance scores to obtain the QLI composite score that ranges from 0 to 30 with higher scores representing better outcomes.|Week 5 and week 11|Participant outcome data collected at week 5 and week 11|||units on a scale||Standard Error|Least Squares Mean
2660134|NCT01582971|Primary|Patient Reported Outcomes Measurement Information System (PROMIS) V 1.0|"PROMIS-Physical functioning subscale contains four items. Score for each item ranging from 1 to 5, yielding a total score ranges from 4 to 20. Raw score is converted to a T-score using PROMIS scoring rules. The T-scores have mean 50 and standard deviation 10 for the general population.~PROMIS-Satisfaction with participation in social roles subscale contains four items. Score for each item ranges from 0 to 4, yielding a total score ranges from 0 to 16. Raw score is converted to a T-score using PROMIS scoring rules. The T-scores have mean 50 and standard deviation 10 for the general population.~Higher scores representing better outcomes in each subscale."|Week 5 and week 11|Participant outcome data collected at week 5 and week 11|||units on a scale||Standard Error|Least Squares Mean
2660135|NCT01582971|Primary|The M.D. Anderson Symptom Inventory (MDASI)|"The M.D. Anderson Symptom Inventory (MDASI) evaluates severity of 13 symptoms experienced by cancer patients (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, decreased appetite, drowsiness, dry mouth, sadness, vomiting, numbness/tingling) on the scale from 0=symptom not present to 10=as bad as you can imagine. Summed symptom severity score ranging from 0 to 130 was derived. MDASI also assesses how much symptoms interfered with 6 aspects of daily life: general activity, mood, work (including work around the house), relations with other people, walking, and enjoyment of life on the scale from 0=did not interfere to 10=interfered completely. Summed interference score ranging from 0 to 60 was derived.~Higher symptom severity and interference scores represent worse outcome."|Week 5 and week 11|Patient outcome data collected at week 5 and week 11|||units on a scale||Standard Error|Least Squares Mean
2660136|NCT01582945|Primary|Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28)|Patients will be assessed with HAMD-28 weekly for the first 8 weeks, then every two weeks for another 8 weeks. Participants were considered as responders if there was a ⩾50% improvement on the HAM-D28.|Weekly for total duration of 4 months|The subjects received a total of 6 infusions, twice a week for three weeks.|||participants who met response criteria|||Number
2660137|NCT01582880|Secondary|Systemic Safety|Incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported).|measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52|52 year old white male|||Incidences|||Number
2660138|NCT01582880|Secondary|Ocular Safety|Incidence and severity of ocular adverse events during the study (ophthalmic examination, adverse events spontaneously reported)|measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52|52 year old white male|||Incidences|||Number
2660139|NCT01582880|Secondary|Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers|Number of occurrence of vitritis (sterile or infectious) ulcers. Incidences of ulcers were collected by way of slit lamp photography from time of surgery to final visit.|post op week 52|52 year old white male|||occurrences|||Number
2660140|NCT01582880|Primary|Changes in Corneal Thickness at 2 Millimeter|The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 2 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.|measured at week 4, 6, 26, 32, 52|52 year old white male patient|||micrometer|||Number
2660141|NCT01582880|Primary|Changes in Corneal Thickness at 1 Millimeter|The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 1 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.|measured at week 4, 6, 26, 32, 52|52 year old white male patient|||micrometer|||Number
2660142|NCT01582854|Secondary|Percentage of Participants With a Diagnosis of Dementia|Diagnosis of dementia will be evaluated after 6 and 12 months classified according to International Statistical Classification of Diseases and related Health Problems 10th Revision (ICD-10) [Classification of Mental and Behavioural Disorders, Diagnostic Criteria for Research].|Month 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||percentage of participants|||Number
2660166|NCT01582490|Secondary|Total Postsurgical Opioid Consumption in the Surgical Center|Total amount of opioids (morphine-equivalent mg) administered postsurgically in each group.|10 days|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.|||mg||Standard Deviation|Mean
2660143|NCT01582854|Secondary|Beck Depression Inventory, Version II (BDI-II) at Months 3, 6 and 12|"The BDI-II is a 21-question multiple-choice self-report inventory for measuring the severity of depression. is composed of items relating to symptoms of depression such as hopelessness and irritability, cognitions such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and lack of interest in sex. Each answer is scored on a scale 0 (best) to 3 (worst). Total scores range from 0 to 63 with higher scores indicating more severe depression.~BDI II scale:~0-13 minimal depression~14-19 mild depression~20-28 moderate depression~29-63 severe depression"|Months 3, 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||score on a scale||Standard Deviation|Mean
2660144|NCT01582854|Secondary|EuroQol EQ-5D (EQ-5D) General Health at Months 6 and 12|The EuroQoL included a visual analogue scale where the subject marks how they feel at that moment on a scale from 0 (the worst health that can be imagined) to 100 (the best health that can be imagined).|Months 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||score on a scale||Standard Deviation|Mean
2660145|NCT01582854|Secondary|EuroQol EQ-5D (EQ-5D) at Month 12|EQ-5D is a standardized measure of health status consisting of 5 dimensions: mobility, self -care, usual activities, pain/discomfort and anxiety/depression. The participant rates their level of function in each area using a 5 point scale where 1=no problems (best) to 5=extreme problems (worst). The percentage of participants in each category is reported.|Month 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||percentage of participants|||Number
2660146|NCT01582854|Secondary|EuroQol EQ-5D (EQ-5D) at Month 6|EQ-5D is a standardized measure of health status consisting of 5 dimensions: mobility, self -care, usual activities, pain/discomfort and anxiety/depression. The participant rates their level of function in each area using a 5 point scale where 1=no problems (best) to 5=extreme problems (worst). The percentage of participants in each category is reported.|Month 6|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||percentage of participants|||Number
2660147|NCT01582854|Secondary|Barthel Index at Months 3 and 6|The Barthel Index consists of 10 items that measure a person's daily functioning, specifically the activities of daily living and mobility. The items include: feeding, transfers (bed to chair and back), grooming, toilet use, bathing, mobility (walking on level surface), going up and down stairs, dressing, continence of bowels and bladder. Each performance item is rated, with a given number of points assigned to each level or ranking. Individual scores are summed for a total possible scores ranging from 0 (worst) to 100 (best) with higher scores indicating more independent daily living.|Months 3 and 6|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||score on a scale||Full Range|Median
2660148|NCT01582854|Secondary|Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) at End of Infusion Period, Months 3, 6 and 12|The NIHSS is a tool to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 (normal) to 4 (some level of impairment). The individual scores from each item are summed in order to calculate total possible NIHSS score from 0 (best) to 42 (worst). A negative change from Baseline indicates improvement. ANCOVA model was used for analyses that included treatment and pooled centre as factors and Baseline NIHSS score as a covariate.|Baseline and End of Infusion and Months 3, 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
2660149|NCT01582854|Secondary|Percentage of Participants With a Diagnosis of Dementia|Diagnosis of dementia will be evaluated after 6 and 12 months classified according to International Statistical Classification of Diseases and related Health Problems 10th Revision (ICD-10) [Classification of Mental and Behavioural Disorders, Diagnostic Criteria for Research]. The proportion of participants with dementia was compared between treatments using a Fisher's exact test.|Month 6|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||percentage of participants|||Number
2660150|NCT01582854|Secondary|Percentage of ADAS-cog+ Responders at Time Points 3, 6 and 12 Months|Responder was defined as an improvement of 4 or more from baseline on the ADAS-cog+ scale using observed data. The proportion of responders was compared between treatments using a chi-square test.|Baseline and Months 3, 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||percentage of responders|||Number
2660151|NCT01582854|Secondary|Change From Baseline in Montreal Cognitive Assessment Scale (MoCA) at End of Infusion Period, Months 3, 6 and 12|"The MoCA is a rapid screening test to assess mild cognitive impairment. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 0 to 30 points; a score of 26 or above is considered normal. A positive change from Baseline (BL) indicates improvement.~ANCOVA model was used for analyses that included treatment and pooled centres as factors, plus years of education and baseline MoCA score as covariates."|Baseline, End of Infusion and Months 3, 6 and 12|Participants from the Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analyses at the given time-point.|||score on a scale||Standard Error|Least Squares Mean
2660167|NCT01582490|Primary|Duration of Analgesia|The primary outcome measure is the duration of analgesia, measured by the time (hours) from the end surgery to the subject's first postsurgical opioid administration.|10 days|Of the 8 subjects in the Infiltration - EXPAREL group (efficacy analysis set), 5 were censored, leaving 3 subjects who were administered an opioid. Of the 9 subjects in the Instillation - EXPAREL group (efficacy analysis set), 7 were censored, leaving 2 subjects who were administered an opioid.|||hours|||Number
2668029|NCT01509677|Secondary|Change From V1 to V5 in Absolute Cell Count inInduced Sputum (10^6 Lymphocytes/mL): Between-Treatment Difference||BAseline to 14 weeks||||10^6 lymphocytes/mL||Standard Error|Least Squares Mean
2660152|NCT01582854|Secondary|Change From Baseline in ADAS-cog+ at Month 3 and Month 12|"The ADAS-cog measures cognitive performance by combining the ratings of 11 items. The cognitive domains mainly addressed by ADAS-cog are: memory (short term), language, ability to orientate (reflects memory), construction/planning of simple designs and performance. The extended version of the ADAS-cog (ADAS-cog+) includes 3 additional items: a 2-number cancellation task to test for attention, a delayed recall task to test for memory consolidation and a maze test for executive performance. Each item is scored and then the item scores are totaled. Total scores range from 0 (best) to 90 (worst). Higher scores indicate greater cognitive impairment. A negative change from Baseline indicates improvement.~ANCOVA model was used for analyses that included treatment, pooled centre, and their interaction as factors and Baseline ADAS-cog+ score as a covariate."|Baseline and Months 3 and 12|Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analysis. Missing individual item scores (where only some item scores missing) imputed with worst possible score.|||score on a scale||Standard Error|Least Squares Mean
2660153|NCT01582854|Primary|Change From Baseline in Alzheimer's Disease Assessment Scale + Cognitive Subscale Extended Version (ADAS-cog+) at Month 6|"The ADAS-cog measures cognitive performance by combining the ratings of 11 items. The cognitive domains mainly addressed by ADAS-cog are: memory (short term), language, ability to orientate (reflects memory), construction/planning of simple designs and performance. The extended version of the ADAS-cog (ADAS-cog+) includes 3 additional items: a 2-number cancellation task to test for attention, a delayed recall task to test for memory consolidation and a maze test for executive performance. Each item is scored and then the item scores are totaled. Total scores range from 0 (best) to 90 (worst). Higher scores indicate greater cognitive impairment. A negative change from Baseline indicates improvement.~Analysis of Covariance (ANCOVA) model was used for analyses that included treatment, pooled centre, and their interaction as factors and Baseline ADAS-cog+ score as a covariate."|Baseline and Month 6|Intent-to-treat population, all enrolled participants who received at least one dose of study drug, with data available for analysis. Missing individual item scores (where only some item scores missing) imputed with worst possible score and missing total scores (where all item scores missing) imputed by last observation carried forward.|||score on a scale||Standard Error|Least Squares Mean
2660154|NCT01582789|Primary|Comfortable Wearing Time - Second Intervention|Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for second intervention at week two visit.|2 Weeks|one drop out at first 2 week follow up|||hours||Standard Deviation|Mean
2660155|NCT01582789|Primary|Comfortable Wearing Time - First Intervention|Comfortable Wearing Time. (Participant response in number of hours) Obtained at 2 weeks wear for first intervention at week two visit.|2 Weeks|one drop out at first 2 week follow up|||hours||Standard Deviation|Mean
2660156|NCT01582789|Primary|Comfort - Second Intervention|Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).|2 Weeks|1 subject withdrew from study.|||units on a scale||Standard Deviation|Mean
2660157|NCT01582789|Primary|Comfort - First Intervention|Participant response of comfort for first intervention of study lenses assessed at 2 weeks. Comfort at insertion, comfort at end of day, comfort at 2 weeks, and overall comfort were rated on subjective response scale. (Scale 0-10, 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt).|2 Weeks|one drop out at first 2 week follow up|||units on a scale||Standard Deviation|Mean
2660158|NCT01582789|Primary|Comfort - Second Intervention|Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,|Baseline|one drop out at first 2 week follow up|||units on a scale||Standard Deviation|Mean
2660159|NCT01582789|Primary|Comfort - First Intervention|Comfort - on insertion and overall assessed at baseline for first intervention on a scale 0-10. 0=uncomfortable/cannot tolerate, 10=very comfortable/cannot be felt,|Baseline|one drop out at first 2 week follow up|||units on a scale||Standard Deviation|Mean
2660160|NCT01582490|Secondary|Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Day 10|"Subject-reported satisfaction with postsurgical pain control in the categories of extremely dissatisfied, dissatisfied, neither satisfied nor dissatisfied, satisfied, and extremely satisfied."|Day 10 after surgery|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.|||participants|||Number
2660161|NCT01582490|Secondary|Overall Rating of Subject Satisfaction With Postsurgical Pain Control at Hospital Discharge|"Subject-reported satisfaction with postsurgical pain control in the categories of extremely dissatisfied, dissatisfied, neither satisfied nor dissatisfied, satisfied, and extremely satisfied."|At the time of hospital discharge|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.|||participants|||Number
2660162|NCT01582490|Secondary|Incidence of Opioid-Related Adverse Events|The incidence of adverse events that were assessed as opioid-related|Through 10 Days Post Surgery|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.|||participants|||Number
2660163|NCT01582490|Secondary|Time to Hospital Discharge Being Written|The time (hours) to the hospital discharge being written for subjects in each group,|At the time of hospital discharge|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.|||hours||Standard Deviation|Mean
2660164|NCT01582490|Secondary|Pain Intensity Assessment at the Time of Hospital Discharge|Subject-reported pain assessment at the time of hospital discharge (assessed an average of 3.11 hours after surgery for the Instillation group and 3.20 hours after surgery for the Infiltration group) on a scale from 0 to 10 where 0 = no pain and 10 = worst possible pain.|At the time of hospital discharge|There were 8 subjects in the Infiltration - EXPAREL efficacy analysis set and 9 subjects in the Instillation - EXPAREL efficacy analysis set.|||units on a scale||Standard Deviation|Mean
2660165|NCT01582490|Secondary|Pain Intensity Assessment Upon Waking in the PACU|Subject-reported pain assessment upon waking in the PACU on a scale of 0 to 10 where 0 = no pain and 10 = worst possible pain.|Upon waking in the PACO post surgery|There were 9 subjects in the Infiltration - EXPAREL efficacy analysis set and 8 subjects in the Instillation - EXPAREL efficacy analysis set.|||units on a scale||Standard Deviation|Mean
2660168|NCT01582477|Secondary|Overall Rating of Subject Satisfaction With Postsurgical Pain Control|Mean of subject satisfaction offered on a 5-point Likert scale (1 = extremely dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = extremely satisfied)|24 hours, 72 hours, and day 10|72 hour reported subject satisfaction at|||units on a scale||Standard Deviation|Mean
2660169|NCT01582477|Secondary|Incidence of Prespecified Opioid-related Adverse Events|Number of subjects|Until hospital discharge order was written, anticipated at 24 hours.||||Number of subjects|||Number
2660170|NCT01582477|Secondary|Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.|Number of pills|48, 72, 96 hours, and 10 days|96 hour measurement given|||Number of tablets||Standard Deviation|Mean
2660171|NCT01582477|Secondary|Physician/Healthcare Professional Assessed Postsurgical Pain|11-point NRS (0-10, 0=no pain, 10=worst possible pain)|1, 2, 6, 12, 24 hours after TAP|24 hour NRS is reported|||units on a scale||Standard Deviation|Mean
2660172|NCT01582477|Secondary|Subject Reported Postsurgical Pain|11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain)|1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP|Data shown are from the 72-hour time point|||units on a scale||Standard Deviation|Mean
2660173|NCT01582477|Primary|The Duration of Abdominal Analgesia From Infiltration Into the TAP||First postsurgical administration of an opioid|Per protocol|||hours||Inter-Quartile Range|Median
2660174|NCT01582451|Secondary|Number of Participants With Change in Anti-LY2605541 Antibodies|The number of participants with a treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable, or from detectable to the value with at least 130% relative increase from baseline.|Baseline through 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable anti-LY2605541 antibody data at baseline and post-baseline.|||participants|||Number
2660175|NCT01582451|Secondary|Change From Baseline in Lipid Profile|Concentrations of cholesterol, high-density lipoprotein cholesterol (HDL-C), LDL-C, and triglycerides are summarized. LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], LDL-C [<100 mg/dL and ≥100 mg/dL, except for the LDL-C outcome variable], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable.|Baseline, 26 weeks, 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable lipid data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2660176|NCT01582451|Secondary|Change From Baseline in Body Weight|LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], LDL-C [<100 mg/dL and ≥100 mg/dL, except for the LDL-C outcome variable], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline body weight.|Baseline, 26 weeks, 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable body weight data at both baseline and post-baseline.|||kilograms (kg)||Standard Error|Least Squares Mean
2660177|NCT01582451|Secondary|Adult Low Blood Sugar Survey (LBSS) Score|LBSS (also referenced as Hypoglycemia Fear Survey - II [HFS-II]) is a 33-item questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using ANCOVA with treatment and stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], and SU or meglitinide use) as fixed effects and baseline value of the LBSS score as a covariate.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable LBSS data at both baseline and post-baseline. Missing endpoints were imputed by applying the LOCF method to the post-baseline data.|||units on a scale||Standard Error|Least Squares Mean
2660178|NCT01582451|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ) Score|ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where a higher score indicate better treatment satisfaction. LS means were calculated using ANCOVA with treatment and stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], and SU or meglitinide use) as fixed effects and baseline value of the ITSQ score as a covariate.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable ITSQ data at both baseline and post-baseline. Missing endpoints were imputed by applying the LOCF method to the post-baseline data.|||units on a scale||Standard Error|Least Squares Mean
2660179|NCT01582451|Secondary|European Quality of Life - 5 Dimension (EuroQol-5D) Score|The EuroQol-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a 3-level scale of 1-3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using an analysis of covariance (ANCOVA) model adjusting for treatment, stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], and SU or meglitinide use), and baseline EuroQol-5D score.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable EuroQol-5D data at both baseline and post-baseline. Missing endpoints were imputed by applying the LOCF method to the post-baseline data.|||units on a scale||Standard Error|Least Squares Mean
2660180|NCT01582451|Secondary|Number of Insulin Dose Adjustments to Steady-state|The number of dose adjustments required to reach a steady dose is presented. LS means were calculated from negative binomial regression models, where the number of dose adjustments = treatment + stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use).|Baseline through 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable insulin dose data at both baseline and post-baseline.|||number of dose adjustments||Standard Error|Least Squares Mean
2660181|NCT01582451|Secondary|Insulin Dose Per Kilogram of Body Weight|Daily basal insulin dose is presented. LS means were calculated using MMRM adjusting for the stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), treatment, visit, treatment-by-visit interaction, and baseline insulin dose.|26 and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable insulin dose data.|||units per kilogram per day (U/kg/day)||Standard Error|Least Squares Mean
2660182|NCT01582451|Secondary|HbA1c|LS means were calculated using MMRM adjusting for stratification factors (country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.|26 and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
2660183|NCT01582451|Secondary|6-point Self-monitored Blood Glucose (SMBG)|SMBG measurements were taken at 6 time points (pre-morning meal [fasting], pre-midday meal, pre-evening meal, bedtime, approximately 0300 hours, and pre-morning meal [fasting] on the next day) and were performed on 2 non-consecutive days in the week prior to next office visit. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline BG values.|26 and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2660184|NCT01582451|Secondary|Intra-participant Variability in Fasting Blood Glucose (FBG)|FBG was measured by self-monitored blood glucose (SMBG). Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM adjusting for the stratification factors (country, baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), treatment, visit, treatment-by-visit interaction, and baseline FBG intra-participant variability.|26 and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FBG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2660185|NCT01582451|Secondary|Fasting Blood Glucose (FBG) (by Self Monitoring)|LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.0% and >8.0%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline FBG.|26 and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FBG data at both baseline and post-baseline.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2660186|NCT01582451|Secondary|Fasting Serum Glucose (FSG) (by Laboratory)|LS means were calculated using MMRM adjusting for stratification factors (country, baseline HbA1c [≤8.0% and >8.0%], baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline FSG.|26 and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FSG data at both baseline and post-baseline.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2660187|NCT01582451|Secondary|Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia|Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with HbA1c <7.0% without nocturnal hypoglycemia by the total number of participants analyzed, multiplied by 100.|26 and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with by applying the LOCF method to the post-baseline data.|||percentage of participants|||Number
2660188|NCT01582451|Secondary|Percentage of Participants With HbA1c Equal to or Less Than (≤) 6.5% and Less Than (<) 7.0%|The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.|26 and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with by applying the last observation carried forward (LOCF) method to the post-baseline data.|||percentage of participants|||Number
2660189|NCT01582451|Secondary|Percentage of Participants That Have Total and Nocturnal Hypoglycemic Events|Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||percentage of participants|||Number
2660190|NCT01582451|Secondary|Rate of Total and Nocturnal Hypoglycemia Events (Adjusted by 30 Days)|Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event occurred between bedtime and waking. Group mean rates of total and nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline hypoglycemia rate + baseline SU or meglitinide use, with log [exposure in days/30] as an offset variable). Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||events/participant/30 days||Standard Error|Least Squares Mean
2660191|NCT01582451|Secondary|Change From Baseline to 52 Weeks in HbA1c|LS means were calculated using MMRM adjusting for stratification factors (country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and SU or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.|Baseline, 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
2660192|NCT01582451|Primary|Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c)|HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for stratification factors (country, baseline low-density lipoprotein cholesterol [LDL-C, <100 milligrams per deciliter (mg/dL) and ≥100 mg/dL], and sulfonylurea (SU) or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.|Baseline, 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
2660193|NCT01582308|Secondary|Pharmacokinetic Analysis: Time to the Peak Plasma Drug Concentration (Tmax)|Measurement of the time to the peak plasma drug concentration following the Day 5 morning dose.|Predose (0 hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20, 24, 36, 48 and 96 hours after the morning dose on Day 5|All participants who had at least at least one measurement.|||hr||Full Range|Median
2660194|NCT01582308|Secondary|Pharmacokinetic Analysis: Peak Plasma Drug Concentration (Cmax)|Measurement of the peak plasma drug concentration following the Day 5 morning dose.|Predose (0 hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20, 24, 36, 48 and 96 hours after the morning dose on Day 5|All participants who had at least at least one measurement.|||nM||Geometric Coefficient of Variation|Geometric Mean
2660195|NCT01582308|Secondary|Pharmacokinetic Analysis: Area Under the Curve 0-12 Hours (AUC 0-12hr) for Vildagliptin 50 mg BID|AUC 0-12hr is the area under the plasma drug concentration-time curve calculated for the 12 hour interval after the Day 5 morning dose for the vildagliptin 50 mg BID dose only.|Predose (0 hours) and 0.5, 1, 2, 4, 8 and 12 hours after the morning dose on Day 5|All participants who had at least at least one measurement. This outcome measure is for the vildagliptin 50 mg BID dose only; therefore, results are only presented for vildagliptin 50 mg BID dose.|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
2660196|NCT01582308|Secondary|Pharmacokinetic Analysis: Area Under the Curve 0-24 Hours (AUC 0-24hr)|AUC 0-24hr is the area under the plasma drug concentration-time curve calculated for the 24 hour interval after the Day 5 morning dose.|Predose (0 Hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20 and 24 hours after the morning dose on Day 5|All participants who had at least at least one measurement.|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
2660197|NCT01582308|Primary|Percent Inhibition of Dipeptidyl Peptidase IV (DPP-4) Activity at Trough|Percent inhibition of DPP-4 activity at 24 hours after the Day 5 morning dose (i.e., at trough) was determined by analysis of blood samples collected from the study participants.|24 hours following the final morning dose on Day 5|All participants who had at least at least one measurement.|||Percent inhibition||95% Confidence Interval|Least Squares Mean
2660198|NCT01582282|Primary|Triglyceride Change From Baseline|Change is defined as Post-Baseline minus Baseline|12 weeks|Analysis of Covariance of Cholesterol Measures Intent-to-Treat|||mg/dL||Standard Error|Mean
2660199|NCT01582282|Primary|Total Cholesterol Change From Baseline|Change is defined as Post-Baseline minus Baseline|12 weeks|Analysis of Covariance of Cholesterol Measures Intent-to-Treat|||mg/dL||Standard Error|Mean
2660200|NCT01582282|Primary|Change From Baseline in Fasting LDL Cholesterol|Change is defined as Post-Baseline minus Baseline|12 weeks|The LDL cholesterol values for two subjects at week 12 were unreportable.|||mg/dL||Standard Error|Mean
2660201|NCT01582282|Primary|Change From Baseline in Fasting HDL Cholesterol|Change is defined as Post-Baseline minus Baseline|12 weeks|Analysis of Covariance of Cholesterol Measures Intent-to-Treat|||mg/dL||Standard Error|Mean
2660202|NCT01582282|Primary|Change From Baseline in Fasting HbA1c|Change is defined as Post-Baseline minus Baseline|12 weeks||||percentage of total hemoglobin||Standard Error|Mean
2660203|NCT01582282|Primary|Change From Baseline in Fasting Glucose|Change from Baseline is defined as the Post-Baseline value subtracted from the Baseline value|12 weeks|Intent-to-Treat|||mg/dL||Standard Error|Mean
2660204|NCT01582243|Secondary|The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment|Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively.|week 12, week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement|||percentage of participants|||Number
2660205|NCT01582243|Secondary|Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week|Mean amplitude of glycemic excursions (MAGE), which was used to quantify major swings of glycaemia and assess intra-day glycemic variability, was measured by inserting continuous glucose monitoring system (CGMS) in patients for 72 consecutive hours before Day 1 (Visit 2) and Week 24 (Visit 5). In order to unify the different initial time and time of completion in each patient, only the data recorded from Day 2 00:00 to Day 3 23:59 with total 48 hours were analyzed.|Baseline, week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement|||mg/dL||Standard Deviation|Mean
2660206|NCT01582243|Secondary|Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24|PPG analysis will be performed on a blood sample obtained by study personnel.|Baseline, week, week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement|||mg/dL||Standard Deviation|Mean
2660207|NCT01582243|Secondary|Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24|FPG analysis will be performed on a blood sample obtained by study personnel.|Baseline, week 12, week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement|||mg/dL||Standard Deviation|Mean
2660208|NCT01582243|Secondary|Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c analysis will be performed on a blood sample obtained by study personnel.|Baseline, week 12|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement|||percentage||Standard Deviation|Mean
2660209|NCT01582243|Primary|Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|HbA1c analysis will be performed on a blood sample obtained by study personnel.|Baseline, Week 24|Intent to Treat (ITT) population: all enrolled patients who took at least one tablet of vildagliptin plus metformin 50/500 mg, and had Baseline and at least one post treatment evaluation for efficacy measurement|||percentage||Standard Deviation|Mean
2660210|NCT01582178|Primary|Cecal Intubation Time|= time between introduction of the colonoscope into the anus and reaching the cecum.|1-30||||minute||Standard Deviation|Mean
2660211|NCT01582178|Secondary|Patient Comfort During Insertion Phase of the Colonoscopy||3 months|||||||
2660212|NCT01582178|Primary|Cecal Intubation Time||3 months|||||||
2660213|NCT01582152|Secondary|Objective Response Rate (ORR)|ORR is number participants who experience complete response (CR) or partial response (PR) analyzed for completion of at least one cycle in all treatment arms, including exploratory treatment arm. CR requires: 1) complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks; 2) no new lesions; 3) stable or improved non-enhancing (T2/FLAIR) lesions; 4) off corticosteroids (or on physiologic replacement doses only); 5) stable or improved clinically. Partial response (PR) requires: 1) >50% decrease compared with baseline in sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; 2) No progression of non-measurable disease; 3) No new lesions; 4) Stable or improved non-enhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; 5) corticosteroid dose at time of scan should be < dose at baseline scan; 6) Improved or stable clinically|1 year|Two participants, one in each arm was not evaluable for response.|||percentage of participants|||Number
2660214|NCT01582152|Primary|Progression Free Survival (PFS)|Progression free survival (PFS) measured from time of registration until date of progression or death (whichever is earlier) (event time) or last date participant was known to be alive without progression (censoring time).|PFS will be evaluated as a continuous variable, up to one year||||weeks||Full Range|Median
2660215|NCT01582139|Secondary|Time in Range|Percent time spent within target (70-180 mg/dL) range.|26 hours (x2 admissions)|Twelve subjects completed the study. The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented below.|||percentage of time spent in range||Standard Error|Mean
2660216|NCT01582139|Secondary|Average Glucose Drop|Average glucose drops at specific time points after the onset of exercise; defined as the difference between plasma glucose at onset of exercise and the glucose values reached at 40 and 60 min post onset of exercise.|26 hours (2x admissions)|The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented.|||mg/dL||Standard Deviation|Mean
2660217|NCT01582139|Secondary|Low Blood Glucose Index|"A measure of the risk of hypoglycemia. It quantifies the frequency and the extent of low BG readings.~A LBGI < 2.5 is associated with a low-risk of hypoglycemia, LBGI 2.5-5 is associated with a moderate risk of hypoglycemia, and LBGI > 5 is associated with a high-risk of hypoglycemia."|26 hours (x2 admissions)|Twelve subjects completed the study. The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented below.|||index score||Standard Error|Mean
2660218|NCT01582139|Primary|Hypoglycemic Events|Plasma glucose based number of hypoglycemic events, defined as consecutive plasma readings below 70mg/dl to measure the capacity of the system to protect patients against the risk of hypoglycemia. Two events separated by only one Yellow Springs Instrument (YSI) value over 70 are considered to form a single event.|26 hours (x2 admissions)|Twelve subjects completed the study. The first two subjects were excluded from the analysis because of protocol violations during the exercise session (the intensity chosen was very high: rating of perceived exertion of 9 out of 10 instead of rating of perceived exertion of 9 out of 20). Results from the 10 remaining subjects are presented below.|||hypoglycemic events|||Number
2660219|NCT01582100|Primary|Incidence of Nausea in Patients With GERD|number of events of nausea with or without vomiting in patients with GERD in 4 weeks|4 weeks|||||||
2660220|NCT01582061|Secondary|Percent Change From Baseline in Insulin Growth Factor - 1 (IGF - 1) Values|Descriptive summary of the effect of pasireotide on IGF-1|Baseline, week 12, 24 and 48|Number of patients with available data differed at visits|||percent change of ng/ml||Standard Deviation|Mean
2660221|NCT01582061|Secondary|Percent Change From Baseline in Growth Hormone (GH) Values|Descriptive summary of the effect of pasireotide on GH.|Baseline, week 12, 24 and 48|Number of patients with available data differed at visits|||percent change of µg/L||Standard Deviation|Mean
2660222|NCT01582061|Secondary|Percent Change in Cushing's Disease Clinical Signs and Symptoms - Hirsutism|Change from baseline is shown as: Percent change from baseline (BL) =((Post BL value - BL value)/ BL value)*100. Ferriman-Gallway scoring was used: 0=minimum and 36 was maximum in females only.|Baseline, week 12, 24 and 48|Number of patients with available data differed at visits|||percent change in scores||Standard Deviation|Mean
2660223|NCT01582061|Secondary|Percent Change in Cushing's Disease Clinical Signs and Symptoms - Waist Circumference|Clinically relevant threshold (at any time point). Reduction of ≥ 5%, Reduction of ≥ 10%|Baseline, week 12, 24 and 48|Number of patients with available data differed at visits|||percent change of centimeters||Standard Deviation|Mean
2660224|NCT01582061|Secondary|Percent Change in Cushing's Disease Clinical Signs and Symptoms - Muscle Strength|Direct observation of ability to stand unaided: 0=able to stand easily with arms extended, 1=able to stand after several efforts without using arms as assistance, 2=able to stand only by using arms as assistance 3=completely unable to stand|Baseline, week 12, 24 and 48|Number of patients with available data differed at visits|||percent change in scores||Standard Deviation|Mean
2660225|NCT01582061|Secondary|Percent Change in Cushing's Disease Clinical Signs and Symptoms - Weight|Clinically relevant threshold (at any time point) was reduction of ≥ 5%|Baseline, week 12, 24 and 48|Number of patients with available data differed at visits|||percent change in kg||Standard Deviation|Mean
2660226|NCT01582061|Secondary|Percent Change in Cushing's Disease Clinical Signs and Symptoms - Body Mass Index (BMI)|Percent change in patients reducing by at least one class level. Class levels: <25.0, 25.0 to <30.0, ≥ 30.0. Percent change from baseline (BL) =((Post BL value - BL value)/ BL value)*100|Baseline, week 12, 24 and 48|Number of patients with available data differed at visits|||percent change in kg/m2||Standard Deviation|Mean
2660227|NCT01582061|Secondary|Percent Change in Cushing's Disease Clinical Signs and Symptoms - Temperature|degrees celius|Baseline week 12, 24 and 48|Number of patients with available data differed at visits|||percent change in celius||Standard Deviation|Mean
2660228|NCT01582061|Secondary|Percent Change in Cushing's Disease Clinical Signs and Symptoms - Pulse|Change from baseline is shown as: Percent change from baseline (BL) =((Post BL value - BL value)/ BL value)*100|Baseline, week 12, 24 and 48|Number of patients with available data differed at visits|||percent change in bpm||Standard Deviation|Mean
2660229|NCT01582061|Secondary|Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP)|Standing systolic and diastolic BP based on 1 assessment and sitting systolic and diastolic BP was mean of 3 assessments.|Baseline, week 12, 24 and 48|Number of patients with available data differed at visits|||percent change of mmhg||Standard Deviation|Mean
2660230|NCT01582061|Secondary|Percent Change in Cushing Quality of Life and Work Productivity and Activity Impairment-General Health (WPAI-GH) Scores|"A 12-item Cushing's syndrome HRQoL questionnaire (CushingQoL, cf. Webb et al 2008) was implemented and patients who completed 9 or more items at a visit were considered evaluable for that visit. The standardized scores were calculated as follows: 1) Obtain raw scores, denoted by X, as the sum of all the ratings on all the HRQoL questions for a single patient and the score can range from 12 (worst HRQoL) to 60 points (best HRQoL). Therefore, the lower the score, greater the negative impact on HRQoL and 2) obtain standardized score, Y, for a single patient~• Y = 100 (X-12) / (60-12) = 100 (X-12)/48. For example, if a patient answers all 12 items with 'Sometimes' or 'Somewhat', X = 36 and Y = 100 ∙ 24/48 = 50 The WPAI-GH questionnaire was used to assess work productivity and activity impairment. However, there was very limited baseline data and therefore the results and outcomes of the objective, 'change from baseline in WPAI-GH scores' are not included."|Baseline, week 12, 24 and 48|Only patients who completed at least 9 questions on questionnaire were included for that visit.|||percent change in score||Standard Deviation|Mean
2660231|NCT01582061|Secondary|Percentage of Patients Achieving a Reduction of Mean UFC ≥ 50% From Baseline|The 24h-UFC concentration results from three samples during screening were averaged to obtain baseline. After baseline, mean 24h UFC was determined at week 24. At Week 4, 8, 16 and 20, mean 24h UFC was determined from two 24 hour urine collections collected on two consecutive days occurring before the visit. At Week 12, 24 and 48, the mean 24h-UFC from three 24 hour urine collections, collected over the week before the visit, was determined. After Week 24, the mean 24h UFC was determined at 12-week intervals until end of study visit, from two 24 hour collections during two consecutive days prior to each respective visit (except at Week 48). UFC was determined by liquid chromatography tandem mass spectroscopy (LC/MS/MS). The normal ranges were determined by the central laboratory's own reference range. All samples, including screening samples, were analyzed by a central laboratory.|Baseline, week 12, 24 and 48|LOCF Week 24: last available mean 24h-UFC of at least two samples between and including week 12 and week 24; LOCF Week 48: last available mean 24h-UFC of at least two samples between and including week 12 and week 48. Two-sided 95% confidence intervals for proportions are calculated using the exact method|||percentage of participants||95% Confidence Interval|Number
2660232|NCT01582061|Secondary|Percentage of Patients With Mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN)|The 24h-UFC concentration results from three samples during screening were averaged to obtain baseline. After baseline, mean 24h UFC was determined at week 24. At Week 4, 8, 16 and 20, mean 24h UFC was determined from two 24 hour urine collections collected on two consecutive days occurring before the visit. At Week 12, 24 and 48, the mean 24h-UFC from three 24 hour urine collections, collected over the week before the visit, was determined. After Week 24, the mean 24h UFC was determined at 12-week intervals until end of study visit, from two 24 hour collections during two consecutive days prior to each respective visit (except at Week 48). UFC was determined by liquid chromatography tandem mass spectroscopy (LC/MS/MS). The normal ranges were determined by the central laboratory's own reference range. All samples, including screening samples, were analyzed by a central laboratory.|Baseline, week 12, 24 and 48|LOCF Week 24: last available mean 24h-UFC of at least two samples between and including week 12 and week 24; LOCF Week 48: last available mean 24h-UFC of at least two samples between and including week 12 and week 48. Two-sided 95% confidence intervals for proportions are calculated using the exact method|||percentage of participants||95% Confidence Interval|Number
2660233|NCT01582061|Primary|Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE)|Only AEs occurring on or after the start of study treatment and no more than 28 days after the discontinuation of study treatment. A patient with multiple occurrences of an AE under one treatment is counted only once in the AE category for that treatment. A patient with multiple severity grades for an AE while on a treatment, is only counted under the maximum grade.|Baseline up to approximately 256 weeks|Three additional arms were created to display subset of subjects with specific criteria.|||percentage of participants|||Number
2660234|NCT01582009|Secondary|6-month Overall Survival Rate|6-month overall survival rate|The time from registration up to 3 years|All treated and eligible patients. Assessed using Kaplan Meier and Proportional Hazards.|||percentage of participants||95% Confidence Interval|Number
2660235|NCT01582009|Secondary|Median Progression Free Survival|Median progression free survival. Assessed using Kaplan Meier and Proportional Hazards.|The time from registration up to 3 years|All treated and eligible patients|||months||95% Confidence Interval|Median
2660236|NCT01582009|Secondary|Number of Participants With an Adverse Event.|Number of participants with an adverse event. Please refer to the adverse event reporting for more detail.|The time from registration up to 3 years|All treated and eligible patients|||Participants|||Count of Participants
2660237|NCT01582009|Primary|Number of Participants With Clinical Response|Number of participants with clinical response. Response will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors ver 1.0 Committee [JNCI 92(3):205-216, 2000]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST ver. 1.0 criteria.|The time from registration up to 3 years|All treated and eligible patients|||Participants|||Count of Participants
2660238|NCT01582009|Primary|Progression-free Survival (PFS)|6 month PFS survival rate. Calculated as the total number of failures (deaths or progression) divided by the total follow-up or exposure time of patients on study. Assessed using Kaplan Meier and Proportional Hazards.|The time from registration to documentation of disease progression up to 3 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2660239|NCT01581970|Secondary|Overall Survival|Defined as the number of patients alive two years out from study enrollment.|2 years||||Participants|||Count of Participants
2660240|NCT01581970|Secondary|Quality of Life Scores|"Comparison of health related quality of life scores as measured by FACT-G: Functional Assessment of Cancer Therapy - General (constitutes the core of all subscales; the FACT-G can be used with patients of any tumor type)questionnaire.~At this point, the data is not able to be analyzed because the PI left the institution and did not respond to requests for data."|Comparison from Baseline to Week 6 and Week 12|At this point, the data is not able to be analyzed because the PI left the institution and did not respond to requests for data.||||||
2660241|NCT01581970|Secondary|Myeloid-derived Suppressor Cells in Tumor Tissue|Myeloid-derived suppressor cells in tumor tissue as measured by immune-histochemistry (IHC)|Week 6|This outcome measure was considered to not be helpful and the data was not collected.||||||
2660242|NCT01581970|Secondary|Aggregate Ratio of Tregs to Natural Killer (NK) Cells for All Participants|the Ratio of Tregs to NK cells in peripheral blood as measured by flow cytometry for all Participants. Measure of central tendency was collected but the data is not accessible anymore because the PI left institution and did not respond to requests for data.|6 Weeks Post Treatment with Cyclophosphamide|Measure of central tendency could not be used as the data was not originally reported in this manner and is not accessible anymore because the PI left institution and did not respond to requests for data.|||ratio|||Number
2660243|NCT01581970|Secondary|Aggregate Ratio of Tregs to Effector Cells for All Participants|The ratio of Tregs to effector cells (NK cells, CD 8+ lymphocytes, macrophages/monocytes) in tumor tissue as measured by immune-histochemistry (IHC) of tumor tissue for all Participants. Measure of central tendency was collected but the data is not accessible anymore because PI left institution and did not respond to requests for data.|6 Weeks Post Treatment with Cyclophosphamide||||ratio|||Number
2660244|NCT01581970|Primary|Progression|The number of patients without disease progression two years out from study enrollment. Progression of disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria and is as at least a 20% increase in size of the lesion(s) being followed and/or the appearance of one or more new lesions.|At 2 Years||||Participants|||Count of Participants
2660245|NCT01581931|Primary|Maximum Concentration (Cmax) of Metformin|Cmax represents the maximum concentration of metformin in plasma. Note, the geometric mean is actually an adjusted geometric mean.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2660246|NCT01581931|Primary|Area Under Curve From 0 to tz Hours (AUC0-tz) of Metformin|AUC0-tz represents the area under the concentration curve of metformin in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte. Note, the geometric mean is actually an adjusted geometric mean.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
2660247|NCT01581931|Secondary|Terminal Half-life t1/2 of Metformin|The terminal half-life of metformin in plasma is denoted by t1/2.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication|||Hours||Geometric Coefficient of Variation|Geometric Mean
2660248|NCT01581931|Secondary|Time to Maximum Concentration (Tmax) of Metformin|Time from dosing to the maximum concentration of metformin in plasma.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication|||Hours||Full Range|Median
2660249|NCT01581931|Secondary|Area Under Curve From 0 to Infinity Hours (AUC0-infty) of Metformin|AUC0-infty represents the area under the concentration curve of metformin in plasma from time 0 extrapolated to infinity. Note, the geometric mean is actually an adjusted geometric mean.|0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours|Treated set - all subjects taking at least 1 dose of trial medication|||ng·h/mL||Geometric Coefficient of Variation|Geometric Mean
2660250|NCT01581710|Secondary|Relative Change (%) of FEV1 After the Bronchodilator|Relative change in percentage of FEV1 after the bronchodilator, 2weeks after placebo and montelukast administration Relative change (%) in FEV1 = (((FEV1 post-bronchodilator)-(FEV1 pre-bronchodilator))/baseline FEV1) x 100|up to 2 weeks||||% (relative change)||Standard Deviation|Mean
2660251|NCT01581710|Primary|Baseline Lung Function in MMEF|Baseline lung function in maximal mid-expiratory flow before the administration of bronchodilator|up to 2 weeks||||L/s||Standard Deviation|Mean
2660252|NCT01581710|Primary|Baseline Lung Function of FEV1/FVC Before the Bronchodilator|baseline lung function in forced expiratory volume in 1 second/forced vital capacity before the administration of bronchodilator|up to 2 weeks||||none (ratio)||Standard Deviation|Mean
2660253|NCT01581710|Primary|Baseline Lung Function of FEV1 Before the Bronchodilator|baseline lung function in forced expiratory volume in 1 second before the administration of bronchodilator|up to 2 weeks||||L/s||Standard Deviation|Mean
2660254|NCT01581710|Primary|Baseline Lung Function of Xrs10 With IOS Before the Bronchodilator (Pre-Xrs10)|Pre Xrs 10: Reactance at 10Hz before the administration of bronchodilator|up to 2 weeks||||kPa/L/s||Standard Deviation|Mean
2660255|NCT01581710|Primary|Baseline Lung Function of Rrs10 With IOS Before the Bronchodilator|Pre Rrs10: Resistance at 10Hz before the administration of bronchodilator|up to 2 weeks||||kPa/L/s||Standard Deviation|Mean
2660256|NCT01581710|Primary|Baseline Lung Function of Xrs5 With IOS Before the Bronchodilator (Pre-Xrs 5)|Pre Xrs 5: Reactance at 5Hz before the administration of bronchodilator|up to 2 weeks||||kPa/L/s||Standard Deviation|Mean
2660257|NCT01581710|Primary|Baseline Lung Function of Rrs 5 With IOS Before the Bronchodilator (Pre-Rrs5)|Pre Rrs 5: Resistance at 5Hz before the administration of bronchodilator|up to 2 weeks||||kPa/L/s||Standard Deviation|Mean
2660346|NCT01580306|Secondary|Number of Participants With Drug Related Adverse Events|number of participants with investigator-defined drug related adverse events.|drug administration until end-of-study examination (7 to 14 days after drug administration)|treated set|||participants|||Number
2660258|NCT01581684|Primary|Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests|Clinically relevant abnormalities for physical examinations, vital signs (blood pressure, pulse rate, oral body temperature, orthostasis test), 12-lead electrocardiogram (ECG) and clinical laboratory tests. Clinically relevant abnormalities are reported by the investigator as adverse events (AEs).|From drug administration until end of trial examination, up to 13 days|Treated set|||participants|||Number
2660259|NCT01581684|Primary|Number of Participants With Drug Related AEs|Number of participants with drug related adverse events (AEs)|From drug administration until end of trial examination, up to 13 days|Treated set which included all subjects who were administered trial medication and were documented to have taken the dose of investigational treatment|||participants|||Number
2660260|NCT01581684|Secondary|Amount of Analyte Eliminated in Urine From 0h to 4h (Ae0-4)|Amount of analyte (BI 411034) eliminated in urine from the time point 0h to time point 4h.|2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration|PK analysis set|||nmol||Geometric Coefficient of Variation|Geometric Mean
2660261|NCT01581684|Secondary|Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity)|Area under the concentration-time curve of the analyte (BI 411034) in plasma over the time interval from 0 extrapolated to infinity|2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration|PK analysis set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2660262|NCT01581684|Secondary|Time to Maximum Measured Concentration (Tmax)|Time from dosing to maximum measured concentration|2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration|PK analysis set|||h||Full Range|Median
2660263|NCT01581684|Secondary|Maximum Measured Concentration (Cmax )|Maximum measured concentration of the analyte (BI 411034) in plasma|2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration|PK analysis set which included all subjects who were administered trial medication and were documented to have taken the dose of investigational treatment and who provided at least one observation for at least one pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2660264|NCT01581658|Primary|Maximum Concentration|Maximum concentration of the analyte in plasma|Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration|Treated patients|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2660265|NCT01581658|Primary|Area Under the Concentration Time Curve of the Analyte in Plasma|Area under the concentration time curve of the analyte in plasma over the time interval from 0 to infinity|Predose and 20 minutes (min), 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 24h, 36h 48h, 72h and 96h after drug administration|Treated patients|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2660266|NCT01581658|Primary|Change From Baseline in Total Urinary Glucose Excretion (UGE)|change from baseline in total urinary glucose excretion (UGE) to 24 hours|baseline and 24 hours|Treated patients who had complete urine sample (baseline and 24 hours) for analyses.|||mg||95% Confidence Interval|Least Squares Mean
2660267|NCT01581619|Secondary|Breast Cosmesis|"Breast Cosmesis was assessed using a cosmetic scoring system. The data shown represent the latest assessment for each participant at the time of analysis. Cosmetic changes were assessed using the following the following criteria.~Excellent: Little or no observable change~Good: Minimal but identifiable changes~Fair: Significant results of radiotherapy noted~Poor: Severe normal tissue sequelae"|End of treatment, 4-9 weeks post treatment, every six months for first 5 years, then annually for 5 years|The one participant that withdrew consent before outcomes were met was excluded from the analysis.|||Participants|||Count of Participants
2660268|NCT01581619|Secondary|Distant Control Rates|The number of participants that achieved distant control. Distant control is defined as a lack of distant metastasis following the completion of treatment. Distant metastasis refers to the development of disease at distant body sites like the lung, liver, bone, or brain.|2 years|The one participant that withdrew consent before the outcome was met was excluded from the analysis|||Participants|||Count of Participants
2660269|NCT01581619|Secondary|Local Control Rates|The local control rates (analyzed separately for patients with DCIS and invasive cancer). Local control is defined as lack of recurrence in the treated breast and ipsilateral axillary, supraclavicular and internal mammary lymph nodes. Recurrence is defined as the regrowth of tumor cells left following initial therapy and/or the development of new primary tumors unrelated to the original one. DCIS stands for 'Ductal Carcinoma In Situ'.|2 years|The one participant that withdrew consent before the outcome was met was excluded from the analysis|||Participants|||Count of Participants
2660270|NCT01581619|Primary|Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks|"The safety of external-beam PBI in selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions over two weeks. The study will be deemed too toxic if >10% of enrolled patients have at least one of the following outcomes within 24 months of completion of PBI.~Grade 3 or 4 skin/subcutaneous or pulmonary toxicity.~The development of clinical fat necrosis.~The development of rib fracture on the ipsilateral treated side, detected either clinically and/or radiographically.~The data is shown as the number of participants that experienced each of the specific toxicities."|2 years|Analysis does not include the one participant who withdrew consent before outcome was met.|||Participants|||Count of Participants
2660271|NCT01581541|Secondary|Clearance|Clearance was calculated from drug dose and AUC(0-∞).|Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1.||||L/h/kg||Standard Deviation|Mean
2660272|NCT01581541|Secondary|Urinary Excretion (%)|Elimination of the drug was investigated by analysis of an aliquot of the total urine collected in 24 h.|Every void post-treatment on day 1 of cycle 1||||percent of dose recovered||Standard Deviation|Mean
2660733|NCT01576783|Other Pre-specified|Other Long-term Outcomes: Sleep|Long-term (26-32 months of age) outcomes. This will be evaluated using scores on the Children's Sleep Habits Questionnaire (CSHQ).|Long-term effect (6 months +) after intervention completion||2021-06-30|06/2021||||
2660273|NCT01581541|Secondary|Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)]|Area Under the Concentration-Time Curve From Time 0 to Infinity was estimated by trapezoidal rule calculations|Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1.||||µM*min||Standard Deviation|Mean
2660274|NCT01581541|Secondary|Area Under the Concentration-Time Curve From Time 0 to 24 Hours [AUC(0-24)]|Area Under the Concentration-Time Curve From Time 0 to 24 Hours was estimated by trapezoidal rule calculations|Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1.||||µM*min||Standard Deviation|Mean
2660275|NCT01581541|Secondary|Terminal Half-life (T1/2)|The terminal half-life (t1/2) was derived from the plasma concentration vs. time data.|Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1.||||hours||Standard Deviation|Mean
2660276|NCT01581541|Secondary|Maximum Observed Plasma Concentration (Cmax)|The maximum concentration (Cmax) was determined by visual inspection of the concentration versus time data.|Before the start of infusion, 30 minutes after the start of infusion, 5 minutes before completion of infusion, and at 1.5, 2, 3, 4, 7, 10, and 24 hours after the start of infusion on day 1 during cycle 1.||||µM||Standard Deviation|Mean
2660277|NCT01581541|Secondary|Number of Days on Treatment||up to 126 days|All participants who continued further treatment and did not start an alternative treatment were considered evaluable for response.|||days||Full Range|Median
2660278|NCT01581541|Secondary|Number of Participants According to Best Response Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)|Number of Participants According to Best Response Per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by computed tomography (CT): Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions.|Baseline and every 6 weeks up to 18 weeks|All participants who continued further treatment and did not start an alternative treatment were considered evaluable for response.|||Participants|||Count of Participants
2660279|NCT01581541|Primary|Maximum Tolerated Dose (MTD) of PU-H71|The MTD is the dose level at which no more than 1 of 6 patients experience DLT during the first cycle of treatment, and the dose below that at which at least 2 (of ≤ 6) patients have DLT as a result of the drug.|Cycle 1 (21 days)||||mg/m^2|||Number
2660280|NCT01581541|Primary|Number of Participants With Adverse Events Possibly, Probably, or Definitely Related to Study Drug|Severity of adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1 Mild adverse event (AE), Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, and Grade 5 Death related to AE.|3 years and two months and 11 days||||Participants|||Count of Participants
2660281|NCT01581541|Primary|Number of Participants With Cycle 1 Dose-limiting Toxicities (DLTs)|A DLT was defined as an adverse event that occurred during cycle 1, was thought to be related to study drug administration, and met one of the following criteria: grade ≥ 3 non-hematologic toxicities (except diarrhea, nausea, vomiting without maximal supportive therapy; alopecia), grade 4 hematologic toxicities (except lymphopenia), and grade 2 ocular toxicity that did not resolve to ≤ grade 1 within 2 weeks. Occurrence of a DLT resulted in a dose reduction following resolution to grade ≤ 2. No more than 2 dose reductions were allowed per patient on study.|Cycle 1 (21 days)||||Participants|||Count of Participants
2660282|NCT01581437|Secondary|Percentage of All Patients Who Underwent Ablation of Rotor/Focal Sources of Atrial Fibrillation|percentage of all patients who had ablation perfornmed|1 year|all patients participating undergo mapping using the 64 pole basket catheter|||percentage of all patients undergoing ab|||Number
2660283|NCT01581437|Secondary|Single-procedure Freedom From Atrial Fibrillation|percentage of patients without prior ablation|one year|percentage of patients who underwent mapping with 64 pole basket catheter|||percentage of patients with no prior abl|||Number
2660284|NCT01581437|Secondary|Mean Time to Recurrence of Atrial Fibrillation|mean time to recurrence of atrial fibrillation|1 year|patients participating undergo mapping using the 64 pole basket catheter|||days||Full Range|Mean
2660285|NCT01581437|Secondary|Number of Participants With Successful Use of 64 Pole Basket Catheter at Non-University of California San Diego Electrophysiology Labs|To determine if the 64 pole basket catheter will be successfully used to gather information on Atrial Fibrillation drivers.|30 min||||participants|||Number
2660286|NCT01581437|Primary|Average Number of Rotors/Focal Drivers in Diverse Locations||30 minutes||||rotor/focal drivers||Standard Deviation|Mean
2660287|NCT01581437|Primary|Percentage of Patients With Greater Than One Right Atrial Source of Rotor/Focal Sources|percentage of patients|30 minutes||||percentage of patients|||Number
2660288|NCT01581437|Primary|Time to Ablation of All Sources|total time taken to ablate all sources of rotors/focal sources in driver locations|30 minutes|patients participating undergo mapping using the 64 pole basket catheter|||minutes||Standard Deviation|Mean
2660289|NCT01581437|Primary|Percentage of Drivers in Right Atrial|To determine where atypical areas of drivers might be.|30 min||||percentage of rotor sources|||Number
2660290|NCT01581307|Secondary|Overall Response Rate (ORR)|The overall response: ORR = complete response (CR) + partial response (PR). Rate will be summarized using both point estimates and exact confidence intervals based on the binomial distribution by groups.|Up to 29 months|All participants evaluable at time of analysis|||Participants|||Count of Participants
2660291|NCT01581307|Secondary|Rate of Progression Free Survival (PFS)|PFS defined as the time from study enrollment to progression in the liver by modified Response Evaluation Criteria in Solid Tumors (RECIST) or death, whichever occurs first will be analyzed and summarized with the survival probabilities over time using Kaplan-Meier method. Confidence intervals for the median PFS rates at different time points will be constructed when appropriate.|Up to 29 months|All participants evaluable at time of analysis|||Participants|||Count of Participants
2660292|NCT01581307|Primary|Median Overall Survival (OS)|OS, defined as the time from study enrollment to death from any cause, will be analyzed and summarized with the survival probabilities over time using Kaplan-Meier method. Confidence intervals for the median OS rates at different time points will be constructed when appropriate.|Up to 29 months|All participants evaluable at time of analysis|||months||95% Confidence Interval|Median
2660293|NCT01581281|Secondary|Occurrence of Treatment Emergent Serious Adverse Events|To determine if amitriptyline or topiramate differ from placebo on the occurrence of treatment emergent serious adverse events.|24 weeks of the trial||||serious adverse events|||Number
2660294|NCT01581281|Secondary|Tolerability, as Indicated by the Number (Percentage) of Participants That Completed the 24-week Treatment Phase|To assess tolerability, the percentage of subjects who complete the entire 24-week treatment period will be estimated in each of the three groups.|24 weeks|Tolerability was assessed for all participants included in the primary analysis. Of those randomized, 33 were not included in the primary analysis due to early trial closure.|||Participants|||Count of Participants
2660295|NCT01581281|Secondary|Change in Number of Headache Days|"This outcomes measure examines whether the rate of absolute number of headache days, per 28 day period, differs between treatment groups over time. This was assessed longitudinally based on the actual number of headache days from the 28 days prior to randomization to the last 28 days of this 24 week trial. The change in absolute headache days was compared between:~Amitriptyline vs. placebo~Topiramate vs. placebo~Amitriptyline vs. Topiramate"|4 week baseline period and last 4 weeks of the 24-week trial|The analysis population included all participants who had observed end-point data: 101 in the topiramate group, 59 in the placebo group, and104 in the amitriptyline group.|||days||Standard Deviation|Mean
2660296|NCT01581281|Secondary|Change in Absolute Headache Disability Score on PedMIDAS|"The PedMIDAS scale which evaluated the impact of headaches in school, home, play, and social activities, is comprised of six items that pertain to days missed in various activities over the past 90 days. Questions were answered by the youth in consultation with their parents and reviewed by study staff. The PedMIDAS scale was administered at baseline (covering the three months prior to enrollment) and at the 24-week endpoint visit (the end of the maintenance period, covering three months of enrollment). A total PedMIDAS score (sum of items 1-6) was used in this trial. Scores range from 0-240; with a score of 0-10 indicating no disability, 11-30 mild disability, 31-50 moderate disability, and more than 50 severe disability in daily activities. The main outcome measure for this comparison will be the difference in the baseline and endpoint (24 week) PedMIDAS total scores for:~Amitriptyline vs. Placebo~Topiramate vs. Placebo~Amitriptyline vs Topiramate"|baseline and 24 week endpoint||||units on a scale||Standard Deviation|Mean
2660297|NCT01581281|Primary|Number (Percentage) of Participants Reporting a ≥ 50% Reduction in Headache Days|"The primary endpoint was a ≥ 50% reduction in headache frequency from the 28 days (4 weeks) baseline period prior to randomization to the last 28 days (4 weeks) of the trial. Headache frequency was defined as the number of days with headache for a given four week 28 day (4 week) period. A headache day was defined as any day during which any headache occurs within a 24 hour period, starting and ending at midnight.~For each participant, the primary endpoint involved a determination of whether a 50% or greater reduction in headache frequency was observed during the last 4 weeks of active treatment as compared with the headache frequency during the 4-week baseline period. Results were compared across the three treatment groups."|4 week baseline period and last 4 weeks of the 24-week trial|The primary endpoint involved a determination of whether a 50% or greater reduction in headache frequency was observed during the last 4 weeks of active treatment as compared with the headache frequency during the 4-week baseline period between the participants receiving amitriptyline and participants receiving placebo.|||Participants|||Count of Participants
2660298|NCT01581021|Secondary|Mobilization and Pain Survey|Using a numeric rating scale (0 = no pain and 10 = unbearable pain), patients were asked to estimate their experienced pain while at rest and when mobile by specifying a number on the scale.|24 months post-operative||||units on a scale||Standard Deviation|Mean
2660299|NCT01581021|Primary|Scoliosis Research Society-30 Survey|Participants were administered a validated survey for evaluating patient quality of life and satisfaction with treatment. Total SRS-30 scores (max = 150) and the domains: function (max = 35), pain (max = 30), self-image (max = 45), mental health (max = 25), and satisfaction with management (max = 15) were analyzed on a scale from 1 (worst) to 5 (best). The mean was obtained by dividing maximum possible score by the number of questions answered.|24 months post-operative||||units on a scale||Standard Deviation|Mean
2660300|NCT01581021|Primary|Rotation|The degree to which the spinal column is rotated from its normal position will be assessed.|24 months post-operative||||degree||Standard Deviation|Mean
2660301|NCT01581021|Primary|Main Thoracic Cobb|X-rays measures the degree of curve in the thoracic spine.|24 months post-operative||||Degree||Standard Deviation|Mean
2660302|NCT01581008|Secondary|Adherence to the Study Protocol (CASA Arm Only)|"The investigators will calculate percentage adherence to pre-specified tasks on the intervention protocol, such as:~how often is depression addressed with a treatment plan?~how often are care team recommendations placed as orders in the medical record?~how often are orders completed?"|3 months|"A variety of process information was analyzed. Please see Bekelman DB et al, Feasibility and acceptability of a collaborative care intervention to improve symptoms and quality of life in chronic heart failure: mixed methods pilot trial Journal of Palliative Medicine 2014, PMID 14329424 for details."|||%in arm severe target symptoms addressed|||Number
2660303|NCT01581008|Secondary|Participation Rates|The investigators will use a CONSORT diagram to display participant flow, and determine how many of those who were approached enrolled in the trial.|7 months|The total population approached was 72 people. 31 consented to be randomized for a participate rate of 43%. Of these, one was a screen failure, and 17 and 13 were randomized to arm 1 and arm 2 respectively.|||participants|||Number
2660304|NCT01581008|Secondary|Was Depression Addressed?|"The Patient Health Questionnaire-9 (PHQ-9) rates nine DSM-IV criteria of depression on a 0 (not at all) to 3 (nearly every day) scale. Scale range is 0-27, with depression severity scored: 0-4 (none), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), 20-27 (severe). The suicidal item is thoughts that you would be better off dead, or of hurting yourself in some way?"|3 months|This analysis was only conducted in CASA participants|||participants|||Number
2668030|NCT01509677|Secondary|Change From V1 to V5 in Absolute Cell Count inInduced Sputum (10^6 Eosinophils/mL): Between-Treatment Difference||Baseline to 14 weeks||||10^6 eosinophils/mL||Standard Error|Least Squares Mean
2660305|NCT01581008|Primary|Cohort Retention|Cohort retention will be determined by examining the proportion of patients who complete the final study visit (at 3-month follow-up) over the total number of patients enrolled in the study (including deceased and lost-to-follow-up). Our goal is an 80% retention rate for this pilot study.|3 months||||participants|||Number
2660306|NCT01580995|Primary|Change in HCV RNA Viral Load|Measure change in HCV RNA viral load in treatment group as compared with placebo|Baseline, 12 weeks|patients who completed 12 weeks of follow up|||log(IU/mL)||Standard Deviation|Mean
2660307|NCT01580969|Secondary|Cognitive Change Over Time - GMLT|The Cogstate software was used to assess cognitive function at baseline, 4 weeks post-radiation, 12 weeks post-radiation, and 26 weeks post-radiation. Mean scores and standard deviations from baseline and 26 weeks post-radiation are reported here. Groton Maze Learning Test (GMLT) measures special learning and executive functioning, including working memory, error monitoring, and ability to integrate feedback to modify problem solving. GMLT score is the number of errors made (lower score indicates better performance).|From start of study treatment until 26 weeks after radiation therapy (29-30 weeks)|16 patients completed the baseline assessment and 3 patients completed the 26 weeks post radiation therapy assessment. Patients were not required to complete the Cogstate assessment if they took more than one hour to complete it, or if they could not operate a computer or if they could not complete the practice tests.|||errors||Standard Deviation|Mean
2660308|NCT01580969|Secondary|Cognitive Change Over Time - OCLT|The Cogstate software was used to assess cognitive function at baseline, 4 weeks post-radiation, 12 weeks post-radiation, and 26 weeks post-radiation. Mean scores and standard deviations from baseline and 26 weeks post-radiation are reported here. One Card Learning Test (OCLT) measures visuoperceptual learning and memory. OCLT is a score defined as the arcsine transformation of the square root of the proportion of correct responses to 80 OCLT questions. The transformed score ranges from 0 to 1.5708 where a higher score means better performance.|From start of study treatment until 26 weeks after radiation therapy (29-30 weeks)|16 patients completed the baseline assessment and 3 patients completed the 26 weeks post radiation therapy assessment. Patients were not required to complete the Cogstate assessment if they took more than one hour to complete it, or if they could not operate a computer or if they could not complete the practice tests.|||Arcsine [(sqrt) proportion correct]||Standard Deviation|Mean
2660309|NCT01580969|Secondary|Cognitive Change Over Time - IDN|The Cogstate software was used to assess cognitive function at baseline, 4 weeks post-radiation, 12 weeks post-radiation, and 26 weeks post-radiation. Mean scores and standard deviations from baseline and 26 weeks post-radiation are reported here. Identification Test (IDN) measures basic information processing and decision speed. IDN is scored based on the speed of performance: mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance.|From start of study treatment until 26 weeks after radiation therapy (29-30 weeks)|16 patients completed the baseline assessment and 3 patients completed the 26 weeks post radiation therapy assessment. Patients were not required to complete the Cogstate assessment if they took more than one hour to complete it, or if they could not operate a computer or if they could not complete the practice tests.|||log10 MS||Standard Deviation|Mean
2660310|NCT01580969|Secondary|Cognitive Change Over Time - DET|The Cogstate software was used to assess cognitive function at baseline, 4 weeks post-radiation, 12 weeks post-radiation, and 26 weeks post-radiation. Mean scores and standard deviations from baseline and 26 weeks post-radiation are reported here. Detection Test (DET) measures sensory registration, vigilance, and reaction time. DET is scored based on the speed of performance: mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance.|From start of study treatment until 26 weeks after radiation therapy (29-30 weeks)|14 patients completed the baseline assessment and 3 patients completed the 26 weeks post radiation therapy assessment. Patients were not required to complete the Cogstate assessment if they took more than one hour to complete it, or if they could not operate a computer or if they could not complete the practice tests.|||log10 ms||Standard Deviation|Mean
2660311|NCT01580969|Secondary|Quality of Life Change Over Time|The M. D. Anderson Symptom Inventory - Brain Tumors (MDASI-BT) scale was used to assess patients at baseline, 4 weeks post-radiation, 12 weeks post-radiation, and 26 weeks post-radiation. Means and standard deviations from baseline and 26 post-radiation are reported here. MDASI-BT is a 28 item assessment using a 0-10 scale. Part 1 contains 22 items and assesses severity of symptoms, with a score range from 0 to 220. Part 2 contains 6 items and assesses the degree to which symptoms interfere with daily life, with a score range from 0 to 60. The Total score adds Part 1 and Part 2 together to assess total symptom burden, with a score range from 0 to 280. For all parts of the assessment, higher scores indicate a lower quality of life and worse symptom burden.|From start of study treatment until 26 weeks after radiation therapy (29-30 weeks)|22 patient completed the baseline questionnaire, and 4 patients completed the 26 week post-radiation questionnaire.|||units on a scale||Standard Deviation|Mean
2660312|NCT01580969|Secondary|Tabulation of Tumor Best Responses|Tabulation of the best tumor response participants achieved from baseline through 26 weeks after the end of radiation therapy. Radiographic Assessment in Neurooncology (RANO) criteria will be used to assess progression and response.|From start of study treatment until 26 weeks after radiation therapy (29-30 weeks)|In Dose Level 0, three patients did not complete any follow-up scans and were excluded from analysis. In Dose Level 2, six patients did not complete any follow-up scans and were excluded from analysis.|||Participants|||Count of Participants
2660313|NCT01580969|Secondary|Progression Free Survival (PFS) at 6 Months|Proportion of patients who have not progressed 26 weeks after the end of radiation therapy. Radiographic Assessment in Neurooncology (RANO) criteria will be used to assess progression and response. Estimates were done by Kaplan-Meier methods to account for patients whose data was censored prior to progression.|From start of study treatment until 26 weeks after radiation therapy (29-30 weeks)|Patients who did not complete the DLT period (3 patients in Dose Level 0) were excluded from PFS analysis.|||probability of survival||95% Confidence Interval|Number
2660347|NCT01580306|Secondary|Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG|Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|from drug administration up to 2 weeks|treated set|||participants|||Number
2660314|NCT01580969|Secondary|Progression Free Survival (PFS) at 3 Months|Proportion of patients who have not progressed 12 weeks after the end of radiation therapy. Radiographic Assessment in Neurooncology (RANO) criteria will be used to assess progression and response. Estimates were done by Kaplan-Meier methods to account for patients whose data was censored prior to progression.|From start of study treatment until 12 weeks after radiation therapy (15-16 weeks)|Patients who did not complete the Dose Limiting Toxicity (DLT) evaluation period (3 patients in Dose Level 0) were excluded from PFS analysis.|||probability of survival||95% Confidence Interval|Number
2660315|NCT01580969|Primary|Number of Participants With Adverse Events|Adverse Events were assessed from start of minocycline treatment (one day prior to start of radiation therapy) until 28 days following the end of radiation therapy. Adverse events were assessed using the Common Terminology for Adverse Events (CTCAE) version 4.0. Each event was assigned a grade (1-5), with lower grades indicating milder events. Events were categorized as severe (grade 3-4) or non-severe (grade 1-2). All adverse events were recorded, regardless of attribution to study treatment. Reported below are the number of patients who experienced any non-severe AE and the number of patients who experienced any severe AE. A full listing of AEs (severe and non-severe) are listed in the Adverse Events module of the Results section.|From first dose of study treatment to 28 days following radiation therapy (7-8 weeks)|In dose level 0, three patients were withdrawn prior to completing the reporting period for the primary objective, making them unevaluable, and they were replaced.|||Participants|||Count of Participants
2660316|NCT01580904|Secondary|LDL Cholesterol|average LDL cholesterol over 24 weeks|Up to 24 weeks||||mg/dL||Standard Deviation|Mean
2660317|NCT01580904|Secondary|Total Cholesterol|average total cholesterol over 24 weeks|Up to 24 weeks||||mg/dL||Standard Deviation|Mean
2660318|NCT01580904|Primary|Fasting Glycemia|average fasting glycemia over 24 weeks|Up to 24 weeks||||mg/dL||Standard Deviation|Mean
2660319|NCT01580904|Primary|Glycated Hemoglobin|average glycated hemoglobin over 24 weeks|Up to 24 weeks|Data are glycated hemoglobin means of all patients per group.|||percent (%)||Standard Deviation|Mean
2660320|NCT01580670|Secondary|The Percent of the Patients Who Experienced an Adverse Event||Until the last time point during the period from administration of the study drug to Week 54|The analysis population is overall patients receiving at least one dose of TA-650 5 mg/kg or 10 mg/kg.|||percentage of participants|||Number
2660321|NCT01580670|Secondary|Serum TA-650 Concentration|Median, Min and Max of serum TA-650 concentration at each evaluation point after dose of 5 mg/kg TA-650.|After dose of Week 0 to 54 or at the timing of discontinuation. On the blood sampling day, before administration of the study drug. Week 0, 22 and 46, before administration and one hour after the administration. Week 14, 30 and 38, before administration.|This table does not include the data after an increased dose of 10 mg/kg. In the case of missing examination values or the case where measurement was impossible due to problems with test samples, the relevant measurement result was treated as a missing value.|||μg/mL||Full Range|Median
2660322|NCT01580670|Secondary|Percent of Patients Who Achieved PCDAI-Based Remission Rate.|"Crohn's Disease Activity Index(PCDAI)-based remission was defined as a case where PCDAI on the evaluation day was decreased to not more than 10. Patients who satisfied the criterion for PCDAI response at least once in the evaluation at Week 2, 6 and 10 were defined as responders at Week 10.~PCDAI was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10)."|Week 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54 and the last time point during the period from administration of the study drug to Week 54|2 patients were discontinued because of an adverse event and a lack of efficacy respectively.|||percentage of participants|||Number
2660323|NCT01580670|Secondary|Change From Baseline of PCDAI Score|Crohn's Disease Activity Index (PCDAI) was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10).|Week 0, 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54|2 patients were discontinued because of an adverse event and a lack of efficacy respectively.|||units on a scale||Standard Deviation|Mean
2660324|NCT01580670|Secondary|PCDAI Score|Crohn's Disease Activity Index (PCDAI) was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10).|Week 0, 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54|2 patients were discontinued because of an adverse event and a lack of efficacy respectively.|||units on a scale||Standard Deviation|Mean
2660325|NCT01580670|Primary|Percent of Patients Who Achieved PCDAI Response|"Crohn's Disease Activity Index(PCDAI) response was defined as a case where PCDAI on the evaluation day was decreased by at least 15 points compared to PCDAI in the screening period and decreased to not more than 30.~PCDAI was the sum (0 to 100) of the scores of 5 large categories. A larger PCDAI score represented higher disease activity. 5 large categories were as follows, i.e. history score (0 to 30), laboratory score (0 to 20), growth score (0 to 20), physical examination score (0 to 20) and extraintestinal manifestation score (0 to 10)."|Week 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, 54, and the last time point during the period from administration of the study drug to Week 54|2 patients were discontinued because of an adverse event and a lack of efficacy respectively.|||percentage of participants|||Number
2660326|NCT01580618|Secondary|Duration of Hospital Stay From the Time of Initiation of Infusion Therapy for the Loculated Effusion|This measures the number of hospital days for each participant after they were started on their infusion therapy.|30 days||||days||Standard Deviation|Mean
2660327|NCT01580618|Secondary|Percentage of Patients Able to Undergo Pleurodesis to Prevent Recurrent Pleural Effusion.||30 days||||percentage of participants|||Number
2660348|NCT01580306|Primary|Cmax|maximum concentration of Faldaprevir in plasma. In this endpoint, the data of Cmax show inter-individual variabilities.|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00h after administration|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2660328|NCT01580618|Secondary|Percentage of Patients Who Fail Initial Therapy (TNK or Saline) Who at the Request of the Hospital-based Doctor Are Then Switched to the Other Arm/Group AND Who Then Achieve Satisfactory Drainage (Saline or TNK) Therapy.|Only one patient who was on normal saline arm/group was switched (by request of the referring hospital-based doctor) to TNKase, but did not have complete clearing of their effusion. No patient in the TNKase arm/group was switched to normal saline. Therefore, we have removed the TNKase arm/group from this portion of the analysis since there are no participants in this group to analyze this outcome measure.|3-5 days||||percentage of participants|||Number
2660329|NCT01580618|Primary|Percentage of Patients With Hemorrhagic Complications Associated With Catheter Drainage|This is the percentage of patients in each arm of the study (Normal saline or TNKase) who suffered a hemorrhagic complication directly associated with instillation of normal saline or TNKase|3-5 days||||percentage of participants|||Number
2660330|NCT01580618|Primary|Percentage of Patients Achieving Complete or Near Complete Drainage of Loculated Pleural Effusion as Determined From Chest Radiography After Three Days or Five Days of Intrapleural Therapy.||3-5 days||||percentage of participants|||Number
2660331|NCT01580592|Secondary|Number of Participants With Abnormal Physical Examinations, Laboratory Assessments, Vital Signs, and Adverse Events|This includes physical examination, routine safety laboratory assessments, vital signs and adverse event reporting|day 70||||participants|||Number
2660332|NCT01580592|Primary|Change in Critical Temperature Thresholds (CTT) From Baseline to Day 70 After Treatment With Omalizumab Compared to Placebo|The primary efficacy outcome was the change in trigger thresholds from baseline to week ten using TempTest® to assess critical temperature thresholds in °C.|day 70|female and male|||degree celcius||Standard Deviation|Mean
2660333|NCT01580488|Secondary|Change in Skin Thickness From Baseline to Day 22|Change in skin thickness - echo-poor band measured by ultrasound from baseline to end of treatment|Baseline to Day 22||||millimeters||Standard Deviation|Mean
2660334|NCT01580488|Secondary|Change in Lesion Thickness From Baseline to Day 22|Change in total skin thickness measured by ultrasound from baseline to end of treatment|Baseline to Day 22||||millimeters||Standard Deviation|Mean
2660335|NCT01580488|Secondary|Change in Scaling From Baseline to Day 22|Investigator's rating of the clinical appearance of scaling . Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to Day 22||||units on a scale||Standard Deviation|Mean
2660336|NCT01580488|Secondary|Change in Infiltration From Baseline to Day 22|Investigator's rating of the clinical appearance of infiltration. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to Day 22||||units on a scale||Standard Deviation|Mean
2660337|NCT01580488|Secondary|Change in Erythema From Baseline to Day 22|Investigator's rating of the clinical appearance of erythema. Maximum score is 3 (most severe); minimum score is 0 (absent).|Baseline to Day 22||||units on a scale||Standard Deviation|Mean
2660338|NCT01580488|Primary|Change in the Total Clinical Score From Baseline to Day 22|Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score. Total Clinical Score range from 0 (all symptoms absent) to 9 (all symptoms severe)|Baseline to Day 22||||units on a scale||Standard Deviation|Mean
2660339|NCT01580423|Primary|Unpleasantness of Breathlessness|"Time-weighted averages of unpleasantness of breathlessness.~Subject rating of unpleasantness of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Unpleasantness and at the top by Greatest Unpleasantness."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)||||units on a scale||Standard Deviation|Mean
2660340|NCT01580423|Secondary|Intensity of Pain|"Time-weighted averages for intensity of pain.~Subject rating of intensity of pain on a 100 mm Visual Analog Scale anchored at the bottom by No Intensity and at the top by Greatest Intensity was obtained during immersion of the subject's non-dominant hand in cold water."|Every 15 seconds during immersion of hand in cold water for up to 5 minutes at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)||||units on a scale||Standard Deviation|Mean
2660341|NCT01580423|Primary|Intensity of Breathlessness|"Time-weighted averages of intensity of breathlessness.~Subject rating of intensity of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Intensity and at the top by Greatest Intensity."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)||||units on a scale||Standard Deviation|Mean
2660342|NCT01580410|Secondary|Quality of Life as Assessed by Functional Assessment of Cancer Therapy: General (FACT-G)|"The FACT-G (Functional Assessment of Cancer Therapy - General) consists of 27 core items assessing patient well-being in four components: Physical (7 items), Social/Family (7 items), Emotional (6 items), and Functional (7 items). Items are rated on a five-point scale: 0-not at all, 1- a little bit, 2-somewhat, 3- quite a bit and 4-very much. The score of each component is the mean times the number of items in the component. The range of the physical, social/family, and functional components I 0-28 and the range of the emotional component is 0-24. The sum of the component scores creates the overall score which has a range of 0-108. For all component scores and overall score, the higher the score the better the QOL."|Throughout study completion, up to 3 years||||units on a scale||Standard Error|Mean
2660343|NCT01580410|Secondary|The Difference in Percentage of Overall Survival Between the Two Treatment Arms up to 3 Years||Interval between surgery and death or date of last contact, assessed up to 3 years||||overall survival rate (%)||Standard Error|Mean
2660344|NCT01580410|Secondary|The Difference in Percentage of Disease-free Survival Between the Two Treatment Arms up to 3 Years||Time to first progression unless the patient's resection status is R2b or 2c, regardless of toxicity or response to study drug, assessed up to 3 years||||disease-free survival rate (%)||Standard Error|Mean
2660345|NCT01580410|Primary|The Difference in the Number of Grade 3 or 4 Hematologic Toxicities (Leukopenia, Thrombocytopenia, and Neutropenia) Between the Mitomycin C and Oxaliplatin Treatments|If a patient has a grade 3 or 4 standard hematologic toxicity (leukopenia, thrombocytopenia, and neutropenia), the patient will be considered to be an event. The observed rates of the 2 treatments will be the primary outcome, and the rates will be analyzed using a 2-sided chi-square test.|Within 4 weeks of surgery||||number of patients with toxicities|||Number
2660349|NCT01580306|Primary|AUC0-∞|"area under the concentration time curve of Faldaprevir in plasma over the time interval from 0 to infinity.~In this endpoint, the data of AUC0-∞ show inter-individual variabilities."|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00,16:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours (h) after administration|Pharmacokinetic (PK) set: This subject set included all subjects in the treated set who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK, and who did not vomit at or before 2 times median tmax of unmetabolised faldaprevir.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2660350|NCT01580293|Other Pre-specified|Volume of Blood Transfused in Major Surgery - Part B|Major surgery was defined as any surgical or invasive procedure (elective or emergent) in which the overall bleeding risk was excessive, required a general anesthetic in an individual without a bleeding disorder, penetrated or exposed a major body cavity, resulted in substantial impairment of physical or physiological functions, or required special anatomic knowledge or manipulative skill.|Up to 3 weeks post-surgery during Part B|Part B ITT population who had blood transfusions during major surgery|||milliliter|surgeries|Full Range|Median
2660351|NCT01580293|Other Pre-specified|Number of Participants Who Took Anti-fibrinolytic Medications During Major Surgery - Part B|Major surgery was defined as any surgical or invasive procedure (elective or emergent) in which the overall bleeding risk was excessive, required a general anesthetic in an individual without a bleeding disorder, penetrated or exposed a major body cavity, resulted in substantial impairment of physical or physiological functions, or required special anatomic knowledge or manipulative skill.|Up to 3 weeks post-surgery during Part B|Part B ITT population with participants treated for major surgery|||Participants|||Count of Participants
2660352|NCT01580293|Other Pre-specified|Maximum Blood Loss During Major Surgery - Part B|Major surgery was defined as any surgical or invasive procedure (elective or emergent) in which the overall bleeding risk was excessive, required a general anesthetic in an individual without a bleeding disorder, penetrated or exposed a major body cavity, resulted in substantial impairment of physical or physiological functions, or required special anatomic knowledge or manipulative skill.|day of surgery|Part B ITT population with participants treated for major surgery|||milliliter|surgeries||Number
2660353|NCT01580293|Other Pre-specified|Number of Participants With Change/Drop in Hemoglobin/Hematocrit Laboratory Assessments - Part B|Hematocrit is defined as the volume percentage (%) of red blood cells in blood.|Up to 3 weeks post-surgery during Part B|Part B Safety population (N=17) included all participants who received at least 1 dose of study drug during Part B of the study.|||Participants|||Count of Participants
2660354|NCT01580293|Other Pre-specified|Number of Surgeries According to Physician's Assessment of Response to Hemostasis, Post-surgery - Part B Main Trial|Response to treatment during surgery was assessed by investigator/surgeon as excellent, good, moderate, poor or missing during Part B of the study.|Up to 3 weeks post-surgery during Part B|Part B ITT population|||surgeries|surgeries||Number
2660355|NCT01580293|Other Pre-specified|Number of Minor Surgeries According to Physician's Assessment of Adequacy of Hemostasis - Part A|Minor surgery was defined as any surgical procedure that did not meet the definition of major, and included simple dental extractions, incision and drainage of abscesses, or simple excisions.|Weeks 0 to 36 during Part A|Part A ITT population|||minor surgeries|minor surgeries||Number
2660356|NCT01580293|Other Pre-specified|Recombinant Human Factor VIII (rFVIII) Usage Expressed as Dose Per Kilogram With Prophylaxis Treatment - Part A|For prophylaxis patients, the dose per kilogram is related to prophylaxis infusions.|Weeks 10 - 36 during Part A|ITT population part A week 10-36, 4 participants dropped out during week 0-10.|||IU/kg||Full Range|Median
2660357|NCT01580293|Other Pre-specified|Recombinant Human Factor VIII (rFVIII) Usage Expressed as Number of Infusions- Part A|For prophylaxis patients, the dose is related to all infusions.|On-demand: Weeks 0 -36 and Prophylaxis: Weeks 10 - 36 during Part A|ITT population part A week 10-36, 4 participants dropped out during week 0-10.|||infusions||Full Range|Median
2660358|NCT01580293|Other Pre-specified|Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire at Week 36 - Part A|The WPAI is a validated instrument to assess the effect of hemophilia on ability to work, attend classes, and perform regular daily activities in participants aged 12 and above. The WPAI also contained classroom impairment questions (CIQ). The questionnaire was self-administered and comprised of nine questions that elicited information on work, classroom, and daily activity impairment during the previous seven days. WPAI outcomes that are overall work and activity impairment, transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Week 0 (baseline) and Week 36 during Part A|Analysis population includes participants evaluable in each category for this outcome.|||scores on a scale||Standard Deviation|Mean
2660359|NCT01580293|Other Pre-specified|Change From Baseline in Overall Pain Severity and Interference Due to Pain at Week 36 - Part A|Brief Pain Inventory (BPI) - Short Form (BPI-SF) was a 15-item, self-administered, validated tool developed to assess pain used in the study for patient reported outcomes. Scores ranged from 0 to 10 and a higher score indicates a higher level of pain/interference.|Week 0 (baseline) and Week 36 during Part A|Analysis population includes participants evaluable in each category for this outcome.|||scores on a scale||Standard Deviation|Mean
2660360|NCT01580293|Secondary|Change From Baseline in Quality of Life by Hemophilia Specific Quality of Life Instrument or Questionnaire for Adults (Haemo-QoL-A) Overall Score at Week 36 - Part A|Quality of life (QoL) was measured by the Haemo-QoL-A overall score, which ranged from 0 (the worst condition) to 100 (the best condition).|Week 0 (baseline) and Week 36 during Part A|Part A ITT population with participants evaluable for this outcome|||scores on a scale||Standard Deviation|Mean
2660361|NCT01580293|Secondary|Overall Human Coagulation Factor VIII (FVIII) Recovery Value by Chromogenic Assay - Part A|Recovery was calculated by the following formula: Recovery = (post-infusion FVIII activity - pre-infusion FVIII activity ) * weight / dose (in IU). Recovery is the increase of FVIII activity after the injection normalized by dose: IU/dl per IU/kg = kg/dL|Weeks 0 to 36 during Part A|Part A ITT population|||Kilogram per deciliter||Standard Deviation|Mean
2660362|NCT01580293|Secondary|Terminal Elimination Half Life (t1/2) Following Single and Multiple Doses of BAY94-9027, Chromogenic Assay - Part A|t1/2: Terminal half-life is the time the plasma concentration during terminal phase is halved following an infusion of 60 IU/kg .|Weeks 0 and 36: pre-infusion (0 hours), post-infusion 15, 30 minutes, 1, 3, 6, 8, 24, 48, 72, 96 hours|PKS with participants evaluable for this outcome|||Hours||Geometric Coefficient of Variation|Geometric Mean
2660363|NCT01580293|Secondary|Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC) Following Single and Multiple Doses of BAY94-9027, Chromogenic Assay - Part A|AUC: The total area under the plasma concentration versus time curve following an infusion of 60 IU/kg .|Weeks 0 and 36: pre-infusion (0 hours), post-infusion 15, 30 minutes, 1, 3, 6, 8, 24, 48, 72, 96 hours|PKS with participants evaluable for this outcome|||h*IU/dL||Geometric Coefficient of Variation|Geometric Mean
2660364|NCT01580293|Secondary|Maximum Drug Plasma Concentration (Cmax) Following Single and Multiple Doses of BAY94-9027, Chromogenic Assay - Part A|Cmax: Maximum observed drug concentration following an infusion of 60 IU/kg|Weeks 0 and 36: pre-infusion (0 hours), post-infusion 15, 30 minutes, 1, 3, 6, 8, 24, 48, 72, 96 hours|Pharmacokinetic Analysis Set (PKS) with participants evaluable for this outcome, PKS included all participants with a valid profile of BAY94-9027 during Part A of the study.|||IU/dL||Geometric Coefficient of Variation|Geometric Mean
2660365|NCT01580293|Secondary|Recombinant Human Factor VIII (rFVIII) Usage Expressed as Number of Infusions for Major Surgery - Part B|Major surgery was defined as any surgical or invasive procedure (elective or emergent) in which the overall bleeding risk was excessive, required a general anesthetic in an individual without a bleeding disorder, penetrated or exposed a major body cavity, resulted in substantial impairment of physical or physiological functions, or required special anatomic knowledge or manipulative skill.rFVIII usage expressed as number of infusions and IU/kg per year, as well as IU/kg per event (surgery) was assessed by investigator.|Up to 3 weeks post-surgery during Part B|Part B ITT population|||infusions|surgeries|Full Range|Median
2660366|NCT01580293|Secondary|Recombinant Human Factor VIII (rFVIII) Usage Expressed as Dose Per Kilogram Per Infusion for Major Surgery - Part B|Major surgery was defined as any surgical or invasive procedure (elective or emergent) in which the overall bleeding risk was excessive, required a general anesthetic in an individual without a bleeding disorder, penetrated or exposed a major body cavity, resulted in substantial impairment of physical or physiological functions, or required special anatomic knowledge or manipulative skill. Total dose per kilogram per Infusion was expressed in international units per kilogram per infusion (IU/kg/infusion).|Up to 3 weeks post-surgery during Part B|Part B ITT population|||IU/kg/infusion|surgeries|Full Range|Median
2660367|NCT01580293|Secondary|Number of Surgeries According to Physician's Assessment of Adequacy of Hemostasis in Major Surgery - Part B|Major surgery was defined as any surgical or invasive procedure (elective or emergent) in which the overall bleeding risk was excessive, required a general anesthetic in an individual without a bleeding disorder, penetrated or exposed a major body cavity, resulted in substantial impairment of physical or physiological functions, or required special anatomic knowledge or manipulative skill. Adequacy of hemostasis was assessed as excellent, good, moderate or poor, by the surgeon or interventionalist during Part B of the study.|Day of surgery|17 participants were included in the Part B ITT population.|||surgeries|surgeries||Number
2660368|NCT01580293|Secondary|Number of Participants Requiring an Increase in Dose Frequency, or Dose Increase, During Weeks 10 to 36 - Part A||Weeks 10 to 36 during Part A|ITT population part A week 10-36, 4 participants dropped out during week 0-10.|||Participants|||Count of Participants
2660369|NCT01580293|Secondary|Recombinant Human Factor VIII (rFVIII) Usage Expressed as Dose Per Kilogram Per Infusion - Part A|For prophylaxis patients, the dose per infusion related to prophylaxis infusion.|On-demand: Weeks 0 -36 and Prophylaxis: Weeks 10 - 36 during Part A|ITT population part A week 10-36, 4 participants dropped out during week 0-10.|||IU/kg/infusion||Full Range|Median
2660370|NCT01580293|Secondary|Recombinant Human Factor VIII (rFVIII) Usage Expressed as Total Dose Per Kilogram Per Year - Part A|For prophylaxis patients, the dose is related to all infusions.|On-demand: Weeks 0 -36 and Prophylaxis: Weeks 10 - 36 during Part A|ITT population part A week 10-36, 4 participants dropped out during week 0-10.|||IU/kg/year||Full Range|Median
2660371|NCT01580293|Secondary|Number of Bleeds According to Participant's Assessment of Response to Treatment - Part A|Response to treatment was assessed by participant as excellent, good, moderate, poor or missing during Part A of the study.|Weeks 0 to 36 during Part A|Analysis population includes participants who presented >=1 bleeding event.|||bleeds|bleeds||Number
2660372|NCT01580293|Secondary|Number of Bleeds Over Time Since Previous Prophylaxis Infusion - Part A||Weeks 0 to 36|Analysis population includes participants who presented >=1 bleeding event.|||bleeds|bleeds||Number
2660373|NCT01580293|Secondary|Number of Bleeds According to Locations - Part A|Bleed locations were categorised as joint, muscle, skin/mucosa, internal, others and missing.|Weeks 0 -36|Analysis population includes participants who presented >=1 bleeding event.|||bleeds|bleeds||Number
2660374|NCT01580293|Secondary|Number of Bleeds Requiring 1, 2 or >= 3 Infusions to Control the Bleed - Part A|Number of bleeds requiring 1, 2 or >= 3 infusions to control the bleeding|Weeks 0 to 36|Part A ITT population, analysis population includes participants who presented >=1 bleeding event.|||bleeds|bleeds||Number
2660375|NCT01580293|Secondary|Number of Participants Developed Human Coagulation Factor VIII (FVIII) Inhibitor - Part A|FVIII inhibitor testing was done according to the Nijmegen modified Bethesda assay. A positive inhibitor test was defined with a threshold of ≥0.6 Bethesda unit (BU) at the central laboratory.|Weeks 0 to 36 during Part A|Part A safety population (N=134) included all participants who received at least 1 dose of study drug during Part A of the study.|||Participants|||Count of Participants
2660376|NCT01580293|Secondary|Annualized Number of Total Bleeds in On-demand Treatment Arm and in Each Prophylaxis Arm, Part A, Extension|Annualized number of total bleeds was defined as the annualized sum of spontaneous bleeds and trauma bleeds.|at least 100 total exposure days acquired, Median (range) time in extension: 464 days (45-700)|ITT extension population. Participants in each regimen stayed on this regimen without switch. Participants who switched regimen were analyzed in the variable frequency arm.|||bleeds||Inter-Quartile Range|Median
2660377|NCT01580293|Secondary|Annualized Number of Joint Bleeds, Trauma, Spontaneous Bleeds in On-demand Treatment Arm (Weeks 0 -36) and in Each Prophylaxis Arm (Weeks 10 - 36, Excluding Rescue Bleeds) - Part A|A participant who had the one-time increase in dose frequency was regarded as rescued. A rescue bleed was a bleed that occured after the dose frequency was increased. Rescue bleeds and periods were not considered for the ABR.|On-demand: Weeks 0 -36 and Prophylaxis: Weeks 10 - 36 during Part A|ITT population part A week 10-36, 4 participants dropped out during week 0-10.|||bleeds||Inter-Quartile Range|Median
2668031|NCT01509677|Secondary|Change From V1 to V5 in Absolute Cell Count inInduced Sputum (10^6 Macrophages/mL): Between-Treatment Difference||Baseline to 14 weeks||||10^6 macrophages/mL||Standard Error|Least Squares Mean
2660378|NCT01580293|Primary|Annualized Number of Total Bleeds in On-demand Treatment Arm (Weeks 0 -36) and in Each Prophylaxis Arm (Weeks 10 - 36, Excluding Rescue Bleeds) - Part A, Main Trial|Annualized number of total bleeds was defined as the annualized sum of spontaneous bleeds and trauma bleeds. A participant who had the one-time increase in dose frequency was regarded as rescued. A rescue bleed was a bleed that occured after the dose frequency was increased. Rescue bleeds and periods were not considered for the annualized bleeding rate (ABR).|On-demand: Weeks 0 -36 and Prophylaxis: Weeks 10 - 36 during Part A|Intent to treat (ITT) population part A week 10-36, 4 participants dropped out during week 0-10.|||bleeds||Inter-Quartile Range|Median
2660379|NCT01580098|Secondary|Number of Hospitalisations|The number of inpatient stays comparing intervention and control group was conducted.|12 months||||number of inpatient stays||Standard Deviation|Mean
2660380|NCT01580098|Secondary|Presence of Diabetic Complications||12 months|No data about the presence of diabetic complications could be analysed at the end of the study, no data was collected for this secondary outcome.||||||
2660381|NCT01580098|Secondary|Medication Changes|Insulin, Change? -> Yes/No|12 months|No data about medical changes could be analysed at the end of the study, no data were collected.||||||
2660382|NCT01580098|Secondary|Body Weight||12 months|baseline demographic characteristics; No patients of the Nurse-Monitoring Group finished the study, as a consequence no Body weight after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.|||kilograms||Standard Deviation|Mean
2660383|NCT01580098|Secondary|Blood Lipids||12 months|Not all Participants delivered reliable data; Measurements at the beginning of the trial and after 12 months; No patients of the Nurse-Monitoring Group finished the study, as a consequence no blood lipids after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.|||mg/dL||Standard Deviation|Mean
2660384|NCT01580098|Secondary|Blood Pressure||12 months|Not all Participants delivered data, reliable data was used. No patients of the Nurse-Monitoring Group finished the study, as a consequence no blood pressure after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.|||mmHg||Standard Deviation|Mean
2660385|NCT01580098|Primary|HbA1c|HbA1c was taken at the beginning of the study and after 12 months.|12 months|No patients of the Nurse-Monitoring Group finished the study, as a consequence no HbA1c after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.|||HbA1c [%]||Standard Deviation|Mean
2660386|NCT01580098|Primary|Health Related Quality of Life as Measured by the Short Form 36 Version 2 Questionnaire|"The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status.~Mearurement at the beginning and after 12 months, Scales from 0 to 100, higher values represent a better outcome; Data are mean scores (SD); differences between groups after 12 month were compared by using Mann-Whitney-U-tests."|12 months|No patients of the Nurse-Monitoring Group finished the study, as a consequence no SF36 after 12 months were delivered, so a calculation and evaluation for this group could not be conducted.|||units on a scale (General health score)||Standard Deviation|Mean
2660387|NCT01580072|Secondary|BODE Index (Carinthia)||12 months|||||||
2660388|NCT01580072|Secondary|St. George's Respiratory Questionnaire SGRQ (Carinthia)|"The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction.~Scores are calculated for three domains:~Symptoms, Activity and Impacts as well as a total score. Psychometric testing has demonstrated its repeatability, reliability and validity. Sensitivity has been demonstrated in clinical trials.~A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. The SGRQ has been used in a range of disease groups including asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis, and in a range of settings such as randomised controlled therapy trials and population surveys.Due to missing data not all questoinnaires could be taken into consideration. Normal distribution is not given for SGRQ scales; Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best pos"|12 months||||units on a scale||Standard Deviation|Mean
2660389|NCT01580072|Secondary|COPD Assessment Test CAT (Carinthia)|No data available|12 months|||||||
2660390|NCT01580072|Secondary|All Cause Mortality|deceased patients in respect to participating patients, by obituary column|12 months|||||||
2660391|NCT01580072|Secondary|Number of Consultations of Emergency Doctor||12 months||||consultations ED||Standard Deviation|Mean
2660392|NCT01580072|Secondary|Number of Specialist Visits||12 months||||visits specialists||Standard Deviation|Mean
2660393|NCT01580072|Secondary|Number of Primary Care Visits|Not all data were available, so only participants with consistent data were taken into comparison, this lead to a lower number of patients in this outcome measurement.|12 months||||visits GP||Standard Deviation|Mean
2660394|NCT01580072|Secondary|Number of Bed Days for Hospitalised Patients||12 months||||bed days||Standard Deviation|Mean
2660395|NCT01580072|Primary|Number of Inpatient Stays||12 months||||inpatient stays||Standard Deviation|Mean
2660396|NCT01580072|Primary|Health Related Quality of Life as Measured by the Short-Form 36 Version 2 Questionnaire; The Short Form (36) Health Survey is a 36-item, Patient-reported Survey of Patient Health. The SF-36 is a Measure of Health Status.|Baseline analyses and analyses after 12 months were conducted. Normal distribution is not given for SF-36 scales, means and Standard Deviation are reported. A high score defines a more favorable health state, items are scored on a 0 to 100 range. Scale scores represent the average for all items in the scale that the respondent answered.|12 months||||units on a scale||Standard Deviation|Mean
2660397|NCT01580020|Secondary|Time to the First Retreatment of Both Treatment Arms|Time to the first retreatment|6 months|The Safety Set consisted of all patients from the safety sets of the respective core study who had received at least one application of study treatment and had at least one safety assessment during the extension study. Patients were analyzed according to treatment received.|||Days||95% Confidence Interval|Median
2660408|NCT01579916|Secondary|Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 180 Days Post Vaccination|An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant. Such events were assessed between Day 1 and Day 181. Investigational product was administered on Day 1.|Study Days 1 - 181|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).|||Percentage of participants|||Number
2660398|NCT01580020|Secondary|Change in Euro Quality of Life Questionnaire (EQ-5D) VAS Summary Scores|"The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participants self-rate their health on a visual, vertical analogue scale from 0 to 100 where the endpoints are labeled Best imaginable health state (100) and worst imaginable health state (0)."|Baseline, month 12|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.|||Score on a scale||Standard Deviation|Mean
2660399|NCT01580020|Secondary|Change in SF-36 Summary Scores|The SF-36 measures the impact of disease on overall quality of life and consists of eight subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health. A positive change from Baseline score indicates improvement in quality of life.|Baseline, month 12|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.|||Score on a scale||Standard Deviation|Mean
2660400|NCT01580020|Secondary|Change in Mean Visual Function Questionnaire (VFQ-25)|The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.|Baseline, 12 months|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.|||Scores on a scale||Standard Deviation|Mean
2660401|NCT01580020|Secondary|Change of Foveal Center Point Thickness (FCPT) From Baseline to Month 12|FCPT (foveal center point thickness) was assessed by central reading center to ensure error- corrected measurements of retinal thickness and volumes,|Baseline, Month 12|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.|||um||Standard Deviation|Mean
2660402|NCT01580020|Secondary|Change in Central Subfield Thickness (CSRT) From Baseline to Month 12|High Resolution OCT was performed at every study visit by Spectral Domain OCT (if not available Time Domain OCT was acceptable) and the images were transferred to a digital video disc. These assessments were performed by trained and adequately qualified experts at the sites and prior to any study drug administration. CSFT is the average retinal thickness of the circular area with 1 mm diameter around the foveal center.|Baseline , Month 12|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.|||um||Standard Deviation|Mean
2660403|NCT01580020|Secondary|Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters at Month 12 Compared to Baseline|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who were gaining/losing ≥15, 10 or 5 more letters of visual acuity at month 12 as compared with baseline|12 month|Full Analysis Sets (FAS) consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Percentage of participants|||Number
2660404|NCT01580020|Secondary|Raw Mean Best Corrected Visual Acuity (BCVA) by Treatment Group|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. The range of BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement|Baseline, 6 months and 12 months|FAS consisted of all patients from the FAS of the respective core study who had received at least one application of study treatment and had at least one post- baseline assessment for BCVA during the extension study. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned.|||Letters read correctly||Standard Deviation|Mean
2660405|NCT01580020|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|The number of participants who experienced Adverse events, serious AE and death|6 months|The Safety Set consisted of all patients from the safety sets of the respective core study who had received at least one application of study treatment and had at least one safety assessment during the extension study. Patients were analyzed according to treatment received.|||Participants|||Number
2660406|NCT01579916|Secondary|Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 14 Days Post Vaccination|Percentage of participants who used an antipyretic or analgesic agent between Days 1 and 15. Investigational product administration occurred on Day 1.|Study Days 1 - 15|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).|||Percentage of Participants|||Number
2660407|NCT01579916|Secondary|Percentage of Participants Who Used Antipyretic or Analgesic Agents Within 7 Days Post Vaccination|Percentage of participants who used an antipyretic or analgesic agent between Days 1 and 8. Investigational product administration occurred on Day 1.|Study Days 1 - 8|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).|||Percentage of Participants|||Number
2660409|NCT01579916|Secondary|Percentage of Participants Reporting Any New Onset Chronic Diseases (NOCDs) Within 28 Days Post Vaccination|An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature and assessed by the investigator as medically significant. Such events were assessed between Day 1 and Day 29. Investigational product was administered on Day 1.|Study Days 1 - 29|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).|||Percentage of participants|||Number
2660410|NCT01579916|Secondary|Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 180 Days Post Vaccination|Percentage of participants reporting at least one SAE between Days 1 and 181. Investigational product was administered on Day 1.|Study Days 1 - 181|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).|||Percentage of participants|||Number
2660411|NCT01579916|Secondary|Percentage of Participants Reporting Any Serious Adverse Event (SAE) Within 28 Days Post Vaccination|Percentage of participants reporting at least one SAE between Days 1 and 29. Investigational product was administered on Day 1.|Study Days 1 - 29|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).|||Percentage of participants|||Number
2660412|NCT01579916|Secondary|Percentage of Participants Reporting Any Adverse Event (AE) Within 14 Days Post Vaccination|Percentage of participants reporting at least one AE between Days 1 and 15. Investigational product was administered on Day 1.|Study Days 1 - 15|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).|||Percentage of participants|||Number
2660413|NCT01579916|Secondary|Percentage of Participants Reporting Other Solicited Symptoms Within 14 Days Post Vaccination|Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.|Study Days 1 - 15|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).|||Percentage of participants|||Number
2660414|NCT01579916|Secondary|Percentage of Participants Reporting Any Adverse Event (AE) Within 7 Days Post Vaccination|Percentage of participants reporting at least one AE between Days 1 and 8. Investigational product was administered on Day 1.|Study Days 1 - 8|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60).|||Percentage of participants|||Number
2660415|NCT01579916|Secondary|Percentage of Participants Reporting Other Solicited Symptoms Within 7 Days Post Vaccination|Solicited symptoms were events that were considered likely to occur post dosing. Solicited symptoms for this study are listed below.|Study Days 1- 8|All participants who received a single dose of investigational product (trivalent influenza virus vaccine = 241; placebo = 60)|||Percentage of Participants|||Number
2660416|NCT01579916|Primary|Percentage of Participants Reporting Fever Within 7 Days Post Vaccination|A comparison of the rate of fever, defined as oral temperature greater than or equal to 101 degrees Fahrenheit, reported during the 7 days post administration of investigational product between the trivalent influenza virus vaccine and placebo groups.|Study Days 1 - 8|All participants who received a single dose of investigational product (trivalent influenza vaccine = 241; placebo = 60).|||Percentage of Participants|||Number
2660417|NCT01579812|Secondary|Overall Survival|Determine the median overall survival time for all patients who complete treatment as well as for patients presenting with stage IIc/ III and stage IV ovarian cancer.|Up to 3 Years|90 patients were enrolled and only 38 patients completed treatment. 25 of the 38 patients had stage IIc/III ovarian cancer. 13 of the 38 patients had stage IV ovarian cancer.|||months||95% Confidence Interval|Median
2660418|NCT01579812|Primary|Recurrence-Free Survival|"Determine the percentage of patients alive without recurrence at 18 months. Investigators will also determine recurrence free survival when patients with persistent disease are excluded.~Definition of progression or recurrence and survival will be defined as increasing clinical, radiological or histological evidence of disease since study entry or two serum values of CA-125 greater than or equal to two times the upper limits of normal (ULN) performed at least one week apart, regardless of CT scan results.~Recurrence-Free Interval will be defined as date from start of chemotherapy to the date of first clinical, biochemical, or radiological evidence of progression or death due to any cause."|18 months|90 patients were enrolled, only 38 completed treatment and were analyzed. Patients found to have persistent disease were censored at the time they were found to have progressive disease. 11 patients had persistent disease.|||percentage of patients||95% Confidence Interval|Number
2660419|NCT01579747|Secondary|Number of Redirections|Number of needle redirections defined as needle withdrawal followed by advancement as an intentional movement.|6 months||||passes||Inter-Quartile Range|Median
2660420|NCT01579747|Primary|Procedural Time|Time taken to complete a sciatic nerve block via the lateral popliteal approach using ultrasound vs nerve stimulation technique|less than 30 minutes||||seconds||Standard Deviation|Mean
2660421|NCT01579669|Secondary|Change in Patient Healthcare Self-Efficacy|"Autistic participants completed a 21-item healthcare self-efficacy scale before and 1 month after use of the toolkit. The scale was created de novo for this study, based on our prior qualitative work. Items addressed aspects related to healthcare navigation (e.g. How confident are you that you can make an appointment with your healthcare provider when needed?), successful interactions with providers, (e.g. How confident are you that you can describe your symptoms or healthcare concerns to your provider?), and self-management (e.g. How confident are you that you can take medications the way you are supposed to take them?). Response options used a 4-point Likert scale with anchors of 0 - Not at all confident to 3 - Totally confident. We scored self-efficacy by adding responses from the 21 items, resulting in a possible range of 0 to 63, with higher scores corresponding to higher self-efficacy. Cronbach's alpha was 0.92."|Before and 1 month after use of toolkit|Participants completing pre- and post-intervention survey themselves (not via a supporter), who had complete data on the self-efficacy scales on both surveys.|||units on a scale||Standard Error|Mean
2660447|NCT01579474|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||participants|||Number
2660422|NCT01579669|Secondary|Change in Patient's Perceived Barriers to Healthcare|Autistic participants were presented with a list of 16 barriers to healthcare and asked which ones keep them from obtaining good care. We compared the total number of barriers endorsed by participants in the pre- and post-intervention surveys. The proxy version of the survey included a few modified items to differentiate between barriers faced by the autistic individuals and those faced by the supporter. Due to differences in the wording, we could not combine results from those who participated directly with those who participated by proxy. Only data from autistic adults who participated directly is shown.|Before and 1 month after use of toolkit|Participants completing the pre and post-test themselves (not via a supporter).|||number of barriers||Standard Error|Mean
2660423|NCT01579669|Secondary|Change in Patient Satisfaction With Healthcare|"Patients completed an 8-item instrument assessing satisfaction with their primary healthcare experiences. The scale was previously adapted from the 2007 Health Information National Trends Survey (HINTS). In the pre-intervention survey autistic participants were asked to think about their last visit with their primary care provider. We did not assess patient-provider communication for those who were participating via a proxy as we did not feel that a proxy could adequately rate how satisfied the patient was with communication. Only autistic participants who said they had seen their PCP since using the healthcare toolkit were re-asked these items in the post-intervention survey. Responses used a 5-point Likert scale with anchors of 1 - Strongly Disagree to 5 - Strongly Agree. We analyzed items by summing the responses into a composite score (range 8-40; higher scores indicate higher satisfaction). Cronbach's alpha = 0.92."|before and 1 month after use of toolkit|Autistic adults who participated directly (not via a proxy) and who saw their provider in the 1 month between when they participated in the baseline assessment and they completed the post-intervention survey.|||units on a scale||Standard Error|Mean
2660424|NCT01579669|Secondary|Patient Use of Toolkit Components|We collected data on whether or not participants completed the Autism Healthcare Accommodations Tool (AHAT) survey and whether or not they allowed the research team to send a copy of the report to their primary care provider.|1 month after use of toolkit||||percentage of participants|||Number
2660425|NCT01579669|Secondary|Provider Satisfaction|Providers participated in a brief survey to assess satisfaction with the toolkit. Items addressed overall satisfaction and if they would or would not use the tools with other patients.|1-2 months after patient uses toolkit|Participants' primary care providers. Primary care providers were included in the study to assess their impression of the toolkit, but all other outcomes (e.g. change in barriers, self-efficacy, or satisfaction with healthcare) only apply to the autistic participants, not their primary care providers.|||percentage of PCPs|||Number
2660426|NCT01579669|Primary|Patient Satisfaction|Autistic participants completed an online survey about their satisfaction with the tool, including if they feel the tool is useful, how they think the tool will affect their healthcare, if and how they plan to use it with providers, and if they would recommend it to others.|1 month after use of toolkit||||percentage of participants|||Number
2660427|NCT01579578|Secondary|The Objective Response Rate (ORR) Was Analysed for Investigating the Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone|The number of subjects with at least one visit response of CR or PR. (Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Not Evaluable (NE), All target lesion measurements are missing or >1/3 target lesion measurements are missing and sum of diameters of non-missing target lesions does not qualify for PD; Not applicable (NA), No target lesions are recorded at baseline)|Baseline and 8 weeks, accessed up to data cut off on 4 December 2012|Full analysis set|||Participants|||Number
2660428|NCT01579578|Secondary|Progression-free Survival (PFS) Were Analysed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone|Time from the date of randomization until the date of objective disease progression (as per RECIST1.1) or the date of death (by any cause in absence of progression).|Baseline and every 8 weeks, accessed up to data cut off on 4 December 2012||||months|Participants|Inter-Quartile Range|Median
2660429|NCT01579578|Primary|Change in Tumour Size at 8 Weeks Were Analyzed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone||Baseline and 8 weeks, accessed up to data cut off on 4 December 2012|Full Analysis Set|||percentage change|Participants|Standard Error|Least Squares Mean
2660430|NCT01579565|Secondary|Systemic Pharmacokinetics (PK) of OMS302|Systemic pharmacokinetics (PK) of phenylephrine (PE) and ketorolac (KE) were performed in a subset of subjects. Descriptive summary statistics for area-under-the-serum-concentration-time curve (AUC), maximum concentration (Cmax), time to Cmax (Tmax), and terminal phase half-life (t1/2) were to be generated if measured plasma concentrations were adequate for analysis. Descriptive statistics for pharmacokinetics were not performed as detected concentrations were low and insufficient for analysis.|24 hours|Subset of subjects randomized to OMS302 treatment.|||participants|||Number
2660431|NCT01579565|Secondary|Postoperative Best Corrected Visual Acuity (BVCA) on Day 1|Best Corrected Visual Acuity (BCVA) summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. The reason for missing scores (e.g., subject could not read enough letters to obtain a score or refraction was not completed) was also summarized. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis.|One day postoperatively|Subjects with score at time point.|||Log score||Standard Deviation|Mean
2660448|NCT01579474|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||participants|||Number
2660449|NCT01579474|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|EOT (up to Week 24 or 48)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||participants|||Number
2660432|NCT01579565|Secondary|Postoperative Ocular Inflammation - Mean Summed Ocular Inflammation Score (SOIS) on Day 1|"Postoperative inflammation as measured using the Summed Ocular Inflammation Score (SOIS), summarized by treatment arm and time point. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|One day postoperatively|Subjects with scores at time point.|||units on a scale||Standard Deviation|Mean
2660433|NCT01579565|Secondary|Ocular Symptoms Using Numerical Rating System (NRS) - Photophobia 1 Day Post-Surgery|Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point.|One day postoperatively|Subjects with scores at time point.|||participants|||Number
2660434|NCT01579565|Secondary|Ocular Symptoms Using Numerical Rating System (NRS) - Photophobia 6 Hours Post-Surgery|Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at each time point.|Six hours postoperatively|Subjects with scores at time point.|||participants|||Number
2660435|NCT01579565|Secondary|Ocular Pain VAS Score on Day 1|VAS pain scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery summarized by treatment arm and time point.|One day postoperatively|Subjects with score at time point.|||units on a scale||Standard Deviation|Mean
2660436|NCT01579565|Secondary|Ocular Pain-Free (VAS Equal to 0) at All Time Points During 12 Hours Postoperatively|The number of subjects who report ocular pain-free status (VAS equal to 0) at all time points during 12 hours postoperatively summarized by treatment arm. Subjects with missing VAS scores during the 12 hours postoperatively were considered as not being pain-free.|12 hours postoperatively|Subjects with scores at time points.|||participants|||Number
2660437|NCT01579565|Secondary|Moderate-to-Severe Pain (VAS Greater Than or Equal to 40) at Any Time Point During 12 Hours Postoperatively|The number of subjects with moderate -to-severe pain (VAS greater than or equal to 40) at any time point during 12 hours postoperatively summarized by treatment arm.|12 hours postoperatively|Subjects with VAS scores at time points.|||participants|||Number
2660438|NCT01579565|Secondary|Pupil Diameter Less Than 6 mm Anytime During Surgery|The number of subjects with pupil diameter less than 6 mm at any time during surgery summarized by treatment arm.|Intraoperative|Subjects with interpretable video images obtained during ILR procedure.|||participants|||Number
2660439|NCT01579565|Secondary|Pupil Diameter Greater Than or Equal to 6 mm at Completion of Cortical Clean up|The number of subjects with pupil diameter of at least 6 mm at the completion of cortical clean up summarized by treatment arm. The last pupil diameter was used if not available at completion of cortical clean up.|at time of cortical clean-up (i.e., end of surgical procedure)|Subjects with interpretable video images obtained during ILR procedure.|||participants|||Number
2660440|NCT01579565|Primary|Mean Area Under the Curve Analysis of Ocular Pain VAS Score Within 12 Hours Postoperatively|The co-primary analysis of the ocular pain VAS (where 0 = no pain and 100 = worst possible pain) based on the mean area under the curve (AUC). The AUC of the ocular pain VAS during 12 hours postoperatively was calculated by the trapezoidal rule in which the hour 11 was used to represent the time-point 10-12 hour. The mean AUC was defined as the AUC divided by the number of hours with ocular pain VAS results during the first 12 hours postoperatively.|12 hours postoperatively|Subjects with scores at time points.|||units on a scale||Standard Deviation|Mean
2660441|NCT01579565|Primary|Mean Area Under the Curve Analysis of Change-from-Baseline in Pupil Diameter (mm) During Surgery|The co-primary analysis of the change in pupil diameter based on the mean area under the curve (AUC) pupil diameter change from baseline. First, the AUC of the pupil diameter from surgical baseline to wound closure was calculated using the trapezoidal rule. Second, the mean AUC was obtained by dividing the AUC by the total time of surgery. Third, the mean AUC of change from baseline was calculated by subtracting the baseline pupil diameter from the mean AUC.|From surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure)|Subjects with interpretable video images obtained during intraocular lens replacement (ILR) procedure.|||mm||Standard Deviation|Mean
2660442|NCT01579513|Secondary|Neurodevelopmental Outcome|Bayley Scales of Infant and Toddler Development version 3 at 1 year. Cognitive, language, and motor composite scores will be used. The general population has a mean of 100 with a standard deviation of 15 for each composite score. Higher scores are better. The minimum composite score is 46 and maximum 154.|1 year||||score on a scale||Standard Deviation|Mean
2660443|NCT01579513|Secondary|Hospital Stay|Total duration of hospital stay following cardiac surgery|Participants will be followed for the duration of hospital stay, an expected average of 5 weeks||||Days||Inter-Quartile Range|Mean
2660444|NCT01579513|Secondary|Intensive Care Unit Stay|Amount of time in the intensive care unit following cardiac surgery|Participants will be followed for the duration of hospital stay, an expected average of 5 weeks||||Days||Inter-Quartile Range|Mean
2660445|NCT01579513|Secondary|Duration of Mechanical Ventilation Post Cardiac Surgery.|Amount of time on mechanical ventilation following cardiac surgery|Participants will be followed for the duration of hospital stay, an expected average of 5 weeks||||Days||Inter-Quartile Range|Median
2660446|NCT01579513|Primary|Number of Participants With a Clinically Derived Composite Morbidity-mortality Outcome|The composite morbidity-mortality outcome will be met if any of the following occur after surgery but before hospital discharge: death, cardiac arrest, extracorporeal membrane oxygenation, renal insufficiency (creatinine more than two times normal), hepatic insufficiency (aspartate aminotransferase or alanine aminotransferase more than two times normal), or rising lactic acidosis (>5mmol/L). This outcome was choosen because death rarely occurs in this population. We have found this endpoint to be highly associated with other important clinical outcomes in this population.|Participants will be followed for the duration of hospital stay, an expected average of 5 weeks||||Participants|||Count of Participants
2660450|NCT01579474|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|EOT (up to Week 24 or 48)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||participants|||Number
2660451|NCT01579474|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||participants|||Number
2660452|NCT01579474|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||participants|||Number
2660453|NCT01579474|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|EOT (up to Week 24 or 48)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||participants|||Number
2660454|NCT01579474|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|EOT (up to Week 24 or 48)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||participants|||Number
2660455|NCT01579474|Secondary|Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8|Plasma HCV RNA level <25 IU/mL (detected or undetected) at Week 4 and HCV RNA <25 IU/mL (undetected) at Week 8|up to 8 weeks|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||percentage of participants|||Number
2660456|NCT01579474|Secondary|Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT)|Plasma HCV RNA level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration|EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||percentage of participants||95% Confidence Interval|Number
2660457|NCT01579474|Secondary|Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)|Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration|EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)|FAS (All patients who were randomized and received at least 1 dose of the trial medication)|||percentage of participants||95% Confidence Interval|Number
2660458|NCT01579474|Primary|Number of Patients With Investigator Defined Drug-related Adverse Events|Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.|Up to 52 weeks|Safety analyses were based on the safety analysis set (SAF) that included all patients who took the trial medication and were documented to have taken at least 1 dose of the trial medication.|||participants|||Number
2660459|NCT01579318|Primary|Objective Response Rate Assessed by Modified Severity Weighted Assessment Tool (mSWAT) Composite Global Score|ORR is defined as the percentage of participants that achieved a complete response (CR) or partial response (PR) as assessed by mSWAT Composite Global Score. This assessment evaluated skin, lymph node, blood and visceral involvement. The response generated in each category was used to determine the Global ORR: CR=complete disappearance of all clinical evidence of disease or, no involvement of disease at baseline through time of response evaluation (NI); PR=regression of measurable disease as follows: 100% clearance of skin lesions, all other categories do not have CR/NI and no category has progressive disease (PD) -OR- 50%-99% clearance of skin disease from baseline without new tumors ( ≥1.0 cm in diameter) in patients with T1, T2 or T4 only skin disease, and if any other category was involved at baseline, at least one has CR/PR and no category has PD.|Every 28 days for the first 24-weeks of treatment|mSWAT Composite Score was not collected and reported due to early termination of the study.||||||
2660460|NCT01579318|Other Pre-specified|Immunologic Effects of IL-12 Plasmid Electroporation in Peripheral Blood|"This outcome measure was erroneously entered as secondary but is truly an exploratory endpoint.~Planned analyses were:~Changes in the proportion of circulating regulatory and effector T cells in peripheral blood.~Changes in phenotype of leukocyte subsets and T cell receptor clonal expansion"|2 years|Due to early termination of the study immunologic effects of IL-12 plasmid electroporation in peripheral blood data was not collected and reported.||||||
2660461|NCT01579318|Other Pre-specified|Immunologic Effects of IL-12 Plasmid Electroporation in Tissue|"This outcome measure was erroneously entered as secondary but is truly an exploratory endpoint.~Planned analyses were:~Transcriptional analysis of interferon pathway activation, antigen presentation and processing machinery (APM) upregulation, and immune cell infiltration in tissue at baseline and post-treatment.~Changes in the characterization of local tissue effects, proportion and phenotype, of intratumoral leukocyte subsets post-treatment.~Changes in T cell receptor clonal expansion and persistence of initial clones post- treatment.~Changes in FOXP3 methylation and quantification of regulatory T cells post- treatment."|2 years|Due to early termination of the study immunologic effects of IL-12 plasmid electroporation in tissue data was not collected and reported.||||||
2660462|NCT01579318|Secondary|Quality of Life (QoL)|Participants were to complete the following QoL assessments prior to clinical evaluations every 4 weeks: Skindex29, FACT-G (Functional Assessment of Cancer Therapy -General) and VAS-P (Visual Analog for Pruritus) questionnaires.|Every 28 days for up to 340 days|Due to early termination of the study QoL data was not collected and reported.||||||
2660506|NCT01579006|Secondary|Percentage of Participants With Type of Previous Biologic RA Treatments|Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment). Same participants may be counted in more than one previous biologic RA treatment category.|Up to 6 months|FAS population.|||percentage of participants|||Number
2660463|NCT01579318|Secondary|Time to Overall Objective Response Assessed by mSWAT Skin Score|Time to overall objective response (CR or PR) is the number of days from the start of therapy to the first documentation of objective response assessed by mSWAT Skin Score: CR=100% clearance of skin lesions; PR= 50%-99% clearance of skin disease from baseline without new tumors ( ≥1.0 cm in diameter) in patients with T1, T2 or T4 only skin disease.|From start of study treatment until overall objective response (Up to 340 days)|All enrolled participants who achieved an objective response.|||days|||Number
2660464|NCT01579318|Secondary|Duration of Overall Objective Response Assessed by mSWAT Skin Score|Duration of overall objective response (CR or PR) is defined as the number of days from the initial documentation of an objective response to the most current evaluation of that response or to documentation of progression assessed by mSWAT Skin Score: CR=100% clearance of skin lesions; PR= 50%-99% clearance of skin disease from baseline without new tumors ( ≥1.0 cm in diameter) in patients with T1, T2 or T4 only skin disease.|From first documented response until disease progression (Up to 340 days)|All enrolled participants who achieved an objective response.|||days|||Number
2660465|NCT01579318|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, medical treatment or procedure and which did not necessarily have to have had a causal relationship with this treatment. An adverse event could have, therefore, been any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, medical treatment or procedure whether or not considered related to the medicinal product. An SAE was defined an any untoward medical occurrence that at any dosage resulted in one or more of the following: death, A life-threatening adverse event (real risk of dying), inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly, required intervention to prevent permanent impairment of damage.|From the start of study treatment up to 340 days|All enrolled participants.|||percentage of participants|||Number
2660466|NCT01579318|Primary|Objective Response Rate Assessed by Modified Severity Weighted Assessment Tool (mSWAT) Score in the Skin|ORR is defined as the percentage of participants that achieved a complete response (CR) or partial response (PR) as assessed by mSWAT score. The mSWAT defines 3 lesion types and assigns each a weighing factor: patch (no induration or significant elevation)=1; plaque (induration, crusting, ulceration or poikiloderma)=2; tumor (solid or nodular ≥ 1 cm in diameter with evidence of deep infiltration and/or vertical growth)=4. Lesions are assessed by body surface area (BSA) where palm + fingers = approximately 1% BSA in each of 12 areas (head, neck, anterior trunk, arms, forearms, hands, posterior trunk, buttocks, thighs, legs, feet, groin), and the sum of each area of BSA is multiplied by its weighing factor. An overall sum of each subtotal represents the mSWAT score (0=no lesions; 400=lesions covering all areas). CR=100% clearance of skin lesions; PR= 50%-99% clearance of skin disease from baseline without new tumors ( ≥1.0 cm in diameter) in patients with T1, T2 or T4 only skin disease.|Every 28 days for the first 24-weeks of treatment|All enrolled participants.|||percentage of participants|||Number
2660467|NCT01579305|Primary|Month 3 Overall Lip Fullness Scale Responder Rate Based on Independent Central Reviewer's Assessment|The primary effectiveness variable is the responder rate (percentage of subjects who show ≥ 1-point improvement on the 5-point Lip Fullness Scale (Minimal, Mild, Moderate, Marked, Very Marked) compared to baseline assessment, as determined by Independent Central Reviewer evaluation of 3D photographic images).|3 months|Per-protocol population (all subjects who are randomized, received at least 1 study treatment, and have no protocol deviations that affect the primary effectiveness endpoint)|||Percentage of subjects||95% Confidence Interval|Number
2660468|NCT01579214|Secondary|Clinic Return Within 28 Days of Abnormal CD4 Count Result|Number of participants who returned to clinic within 28 days of abnormal CD4 count result|28 days||||Participants|||Count of Participants
2660469|NCT01579214|Primary|Participants Initiating Antiretroviral Therapy (ART) Within 28 Days of Abnormal Result|Number of Antiretroviral Therapy (ART) naive participants (subgroup of the sample) who initiated ART within 28 days of receiving abnormal result|28 days|These are participants who were Antiretroviral Therapy naive, and so analysis of this measurement is using this subgroup only.|||Participants|||Count of Participants
2660470|NCT01579084|Primary|Percentage of Responders With at Least a 2-Grade Decrease From Baseline on Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 5|The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 5. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 5-hour 6|Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.|||Percentage of responders|Facial sides||Number
2660471|NCT01579084|Secondary|Percentage of Responders With at Least a 2-Grade Decrease From Baseline on SSA|The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 1 and Day 5. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day1-hour 6, Day 5-hour 6|Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.|||Percentage of responders|Facial sides||Number
2660568|NCT01578551|Primary|Progression Free Survival (PFS)|Number of months without evidence of progression after 1 year of the combination of metformin and standard chemotherapy in patients with previously untreated advanced or metastatic pulmonary adenocarcinoma.|1 year||||months||95% Confidence Interval|Median
2660472|NCT01579084|Secondary|Percentage of Responders With at Least a 2-Grade Decrease From Baseline on CEA|The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score at Day 1 and Day 5. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness.|Baseline, Day 1-hour 6, Day 5-hour 6|Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.|||Percentage of responders|Facial sides||Number
2660473|NCT01579084|Primary|Percentage of Responders With at Least a 2-Grade Decrease From Baseline in Both Clinician Erythema Assessment (CEA) and Subject's Self Assessment (SSA) at Day 1|The percentage of responders was determined by facial sides with at least a 2-grade decrease from Baseline (Improvement) in the CEA score and at least a 2-grade decrease from Baseline (Improvement) in the SSA score at Day 1. The investigator evaluated the severity of the participant's erythema (redness of the skin) as measured by the CEA using a 5-point scale where 0=clear skin with no signs of erythema; 1=almost clear of erythema, slight redness; 2=mild erythema, definite redness; 3=moderate erythema, marked redness and 4=severe erythema, fiery redness. The participant assessed the severity of their erythema as measured by the SSA using a 5-point scale where 0=clear of unwanted redness; 1=nearly clear of unwanted redness; 2=somewhat more redness than I prefer; 3=more redness than I prefer and 4=completely unacceptable redness.|Baseline, Day 1-hour 6|Modified Intent-to-treat population consisted of all randomized patients who received study medication and who had measurements at Baseline and at least 1 post-baseline measurement for both CEA and SSA.|||Percentage of responders|Facial Sides||Number
2660474|NCT01579045|Secondary|Monocular Visual Acuity in Recumbent Position|Visual Acuity measured in LogMAR units. High contrast visual acuity (VA) was measured in both eyes using a 3m LogMAR test chart at 2.5m testing distance (subsequently converted).|up to 60 minutes in recumbent position|Analysis is on those who were enrolled, randomized, and whom completed the study.|||units on a scale (LogMAR)||95% Confidence Interval|Least Squares Mean
2660475|NCT01579045|Primary|Lens Orientation in Recumbent Position|rotation from zero position also described as absolute value of the rotation.|up to 60 minutes in recumbent position|Subjects analyzed were those enrolled, randomized, and whom completed the study.|||degrees||95% Confidence Interval|Least Squares Mean
2660476|NCT01579006|Primary|Percentage of Participants on TCZ Treatment at 5-6 Months After Treatment Initiation||5-6 months|FAS population|||percentage of participants||95% Confidence Interval|Number
2660477|NCT01579006|Secondary|Change From Baseline in Morning Stiffness as Assessed Using VAS at Month 6|Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||mm||Standard Deviation|Mean
2660478|NCT01579006|Secondary|Change From Administration 1 in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Questionnaire at Month 6|The FACIT Measurement System was a collection of health-related quality of life questionnaires targeted to the management of chronic illness and included questions on Physical Well-Being, Social/Family Well-Being, Emotional Well-Being and Functional Well-Being. The FACIT Fatigue Scale was a 13-item tool that measured an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue was measured on a five-point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score of FACIT ranged from 0 to 160. An increase of 4 points in the FACIT-Fatigue score was considered clinically meaningful. Change from Administration 1 was reported for individual administration schedules. TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|Administration 1 (Baseline), 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.|||Score on a scale||Standard Deviation|Mean
2660479|NCT01579006|Secondary|Change From Baseline in Participant's Assessment of RA-Related Pain at Month 6|Severity of pain was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the severity of pain that they had experienced because of their RA, ranging from 0 (no pain) to 100 (unbearable pain). A decrease of 10 points was considered clinically meaningful.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||mm||Standard Deviation|Mean
2660480|NCT01579006|Secondary|Change From Baseline in Participant's Assessment of Fatigue Using VAS at Month 6|Fatigue was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the level of fatigue that they have experienced, ranging from 0 (no fatigue) to 100 (extreme fatigue).|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||mm||Standard Deviation|Mean
2660481|NCT01579006|Secondary|Change From Baseline in HAQ-DI at Month 6|"The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from no difficulty to unable to do, corresponding to scores from 0 to 3. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity. A score of <0.5 represented clinical remission. A participant achieved a clinically meaningful improvement in HAQ-DI if they had a reduction from baseline of >=0.22."|Baseline, 6 months|ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
2660482|NCT01579006|Secondary|Change From Baseline in PGH of Disease Activity at Month 6|"The PGH of disease activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equaled 0 mm, and was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from baseline indicated improvement."|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||mm||Standard Deviation|Mean
2660483|NCT01579006|Secondary|Change From Baseline in PhGH at Month 6|"The PhGH was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equaled 0 mm, and was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from baseline indicated improvement."|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||mm||Standard Deviation|Mean
2660484|NCT01579006|Secondary|Change From Baseline in ESR at Month 6|ESR was a laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube. ESR was measured in mm/hr. A reduction in the level was considered an improvement.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||mm/hr||Standard Deviation|Mean
2660485|NCT01579006|Secondary|Change From Baseline in CRP at Month 6|The test for CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. The serum concentration of CRP was measured in mg/dL. A reduction in the level was considered an improvement.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||mg/dL||Standard Deviation|Mean
2660486|NCT01579006|Secondary|Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response at Month 6|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR70 response required at least a 70% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2660487|NCT01579006|Secondary|Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response at Month 6|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR50 response required at least a 50% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: (participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), and acute phase reactant (CRP or ESR). A reduction in the level of acute phase reactants was considered an improvement.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2660488|NCT01579006|Secondary|Percentage of Participants Who Achieved 20% Improvement in ACR (ACR20) Response at Month 6|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: participant's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2660489|NCT01579006|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 6|The CDAI was a combined index for measuring disease activity in RA and used to evaluate disease activity in the absence of laboratory testing of CRP and ESR. It was the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH (assessed on 0-100 mm); VAS (0 = no disease activity and 100 = worst disease activity). CDAI total score = 0-76. A CDAI score of <=2.8 represented clinical remission, a score of <=10.0 represented low disease activity, a score of <=22.0 represented moderate disease activity and a score of >22.0 represented high (or severe) disease.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
2660490|NCT01579006|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 6|The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician's global assessment (PhGH) of disease activity, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP) (milligrams per deciliter [mg/dL]). SDAI total score = 0-86. A SDAI score of <=3.3 represented clinical remission, a score of <=11.0 represents low disease activity, a score of <=26.0 represented moderate disease activity and a score of >26.0 represented high (or severe) disease.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
2660491|NCT01579006|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6|Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH (mm), and ESR (mm/hr). DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB >=-0.6, DAS28 >3.2 to <=5.1 or CFB >=-0.6 and DAS28 >5.1 or CFB >=-0.6.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2660492|NCT01579006|Secondary|Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) at Month 6|DAS28 was calculated from SJC and TJC using an assessment of 28 joints, the erythrocyte sedimentation rate (ESR) (milliliter per hour [mm/hr]), and Patient's Global Assessment (PGH) of disease activity (measured on a 0 to 100 mm Visual Analogue Scale [VAS] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using the following formula: DAS28 = 0.56*square root (sqrt) (TJC28) + 0.28*sqrt(SJC28) + 0.70*natural logarithm (ln) (ESR) + 0.014*PGH of disease activity. Total score range: 0-10, with a higher score indicated more disease activity. DAS28 <=3.2 implied low disease activity, DAS >3.2 to 5.1 implied moderate disease activity and DAS >5.1 implied high disease activity, and DAS28 <2.6 = clinical remission.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||Score on a scale||Standard Deviation|Mean
2660493|NCT01579006|Secondary|Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Month 6|The number of swollen joints was recorded on the joint assessment form, with no swelling = 0, and swelling =1, for 66 joints, giving a total possible SJC score of 0 to 66.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||Swollen Joint Count||Standard Deviation|Mean
2660494|NCT01579006|Secondary|Change From Baseline in Tender Joint Count (TJC) (68 Joints) at Month 6|The number of tender joints was recorded on the joint assessment form, with no tenderness = 0, and tenderness = 1, for 68 joints, giving a total possible TJC score of 0 to 68.|Baseline, 6 months|FAS population. Here, number of participants analyzed = participants with valid data to calculate TJC at the end of study (6 months).|||Tender Joint Count||Standard Deviation|Mean
2660495|NCT01579006|Secondary|Percentage of Participants on TCZ Monotherapy|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. Only those participants who had TCZ as monotherapy were reported.|Up to 6 months|FAS population. Here, “n”= participants who were evaluable for each category.|||percentage of participants||95% Confidence Interval|Number
2660496|NCT01579006|Secondary|Percentage of Participants Who Adhered to the Dosing Regimen Recommended by Physician|A participant's adherence was calculated based on the adverse event or laboratory abnormality experienced by the participants who required dose modifications as per local TCZ label or protocol.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2660497|NCT01579006|Secondary|Time to Restoration of Initial Dosing Regimen||6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||days||Standard Deviation|Mean
2660498|NCT01579006|Secondary|Percentage of Participants Who Discontinued From TCZ for Safety Versus Efficacy|The safety variable measured the number of participants who discontinued TCZ due to adverse reactions to TCZ, and the efficacy variable measured the participants who discontinued from TCZ due to lack of efficacy according to criteria of the treating physician.|6 months|FAS population.|||percentage of participants||95% Confidence Interval|Number
2660499|NCT01579006|Secondary|Mean Dosing Interval of Treatment at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. The mean dosing interval between different TCZ administrations (Adm) by participants within 6 months observational period was presented.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.|||days||Standard Deviation|Mean
2660500|NCT01579006|Secondary|Mean Number of Dose Modifications at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||dose modification||Standard Deviation|Mean
2660501|NCT01579006|Secondary|Mean Dose at 6 Months|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.|||milligrams per kilogram (mg/kg)||Standard Deviation|Mean
2660502|NCT01579006|Secondary|Percentage of Participants With Reasons for Dose Modification|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations. Only those participants who had dose modifications were reported.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2660503|NCT01579006|Secondary|Percentage of Participants With Dose Modifications|TCZ was administered every 4 weeks according to the label. Due to the observational nature of the study, the suggested schedule was subject to changes according to physician and participant considerations.|6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.|||percentage of participants||95% Confidence Interval|Number
2660504|NCT01579006|Secondary|Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments|Lack of efficacy was determined by physician discretion. Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment).|Up to 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.|||percentage of participants|||Number
2660505|NCT01579006|Secondary|Duration of Previous Biologic RA Treatments|Previous biologic RA treatment included adalimumab, infliximab, golimumab, etanercept, certolizumab, and other (any other previous biologic RA treatment).|Up to 6 months|FAS population. Here, number of participants analyzed = participants who were evaluable for this outcome measure and “n”= participants who were evaluable for each category.|||years||Standard Deviation|Mean
2660507|NCT01579006|Secondary|Percentage of Participants Who Received Biological RA Treatment Prior to Start of Study|"Biological RA treatment exposure was evaluated for all participants. Prior biological RA treatment included participants who were treated with biological RA treatment 8 weeks before being included in the study. Percentage of participants who did not receive any biological RA treatment and percentage of participants who received one or more biologic RA treatments were reported."|Prior to study start (8 weeks)|FAS population.|||percentage of participants|||Number
2660508|NCT01579006|Secondary|Percentage of Participants With Reason for DMARD Withdrawal|Objective intolerance was determined by medical observation; subjective intolerance was determined by the participant; lack of efficacy was determined by physician discretion.|Up to 6 months|FAS population.|||percentage of participants||95% Confidence Interval|Number
2660509|NCT01579006|Secondary|Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study|"DMARDs exposure was evaluated for all participants. Prior DMARDs treatment included participants, who were treated with DMARDs 8 weeks and according to physician's discretion before being included in the study. DMARDs treatment at baseline included participants who were receiving DMARDs when they were included in the study and continued with this concomitant medication in addition to TCZ. Only those participants who received DMARDs prior to start of study and at Baseline up to 6 months were reported."|Prior to study start (8 weeks) and Baseline up to 6 months|FAS population.|||percentage of participants|||Number
2660510|NCT01579006|Secondary|Percentage of Participants With Systemic Manifestations of RA at Baseline|Systemic manifestations included fibromyalgia, osteoporosis, sjogren's syndrome, anemia, rheumatoid nodules, pulmonary fibrosis, vasculitis, peripheral neuropathy or mononeuropathy, scleritis, episcleritis, hypertension, hyperlipidemia, low high-density lipoproteins, diabetes type 1 and type 2, metabolic syndrome, carotid artery disease, transient ischemic attacks, embolic stroke, atherothrombotic stroke, atrial fibrillation, heart failure New York Heart Association (NYHA) Class l/ll, coronary heart disease(angina pectoris/myocardial), aortic aneurism, peripheral arterial occlusive disease, percutaneous coronary interventions, coronary artery bypass, carotid endarterectomy and peripheral arterial bypass.|Baseline|FAS population.|||percentage of participants|||Number
2660511|NCT01579006|Primary|Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation||6 months|FAS population|||percentage of participants||95% Confidence Interval|Number
2660512|NCT01578993|Primary|Rate of PICC Line Occlusions|The incidence, severity and management of PICC line occlusions were recorded for each of the enrolled subjects.|Insertion to Removal / maximum 3 months||||percentage of enrolled subjects|||Number
2660513|NCT01578980|Secondary|Frequency of Unplanned System Resets or Restarts|"Frequency of unplanned system resets or restarts~Secondary endpoints include the estimation of the failure rates of system components, frequency analysis of lost or inaccurate CGM records, and percent time of active CTR. The failure/missing data records will be compared to failure/missing data records from our past in-clinic studies."|42 hours|The three pilot subjects (one for each country) were not included in the analysis.|||events per 24 hours|||Number
2660514|NCT01578980|Primary|Percent Time of Active CTR|The main endpoint will be the percent time with all expected data from CGM, pump and patient manual inputs that should be available on Artificial Pancreas platform and monitoring stations. To be considered as successful, this percent time will have to reach more than 80% of total time of investigation for the entire arm.|42 hours|The three pilot subjects (one for each country) were not included in the analysis.|||percentage of time of active CTR|||Number
2660515|NCT01578967|Other Pre-specified|Exploratory Objective Whether the Cytokine Profile Changes After Treatment|To determine whether the cytokine profile changes after treatment, and to correlate serum levels of cytokines with the overall response after ABVD followed by brentuximab vedotin consolidation|12 months|||||||
2660516|NCT01578967|Secondary|Number of Adverse Events Attributed to Brentuximab Vedotin With a Grade 3 or Higher|Number of adverse events attributed to Brentuximab Vedotin with a grade 3 or higher. Toxicity assessed via the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term.The higher the grade the more severe the adverse event.|12 months|Please note all grade 4 or higher events were experienced by one patient. The patient developed fever and hepatic dysfunction after 1 dose of Brentuximab Vedotin (BV). Patient also developed pancreatitis and eventually died of sepsis.|||Number of events|||Number
2660517|NCT01578967|Secondary|Time to Progression|Defined as the time from ABVD treatment initiation until the time of disease progression or death due to progressive disease.|5 years|||||||
2660518|NCT01578967|Secondary|Progression Free Survival|Defined as the time from ABVD treatment start until disease progression or death from any cause.|5 years|||||||
2660519|NCT01578967|Secondary|Conversion Rate to Complete Response. Number of Participants Who Had a Partial Response Post ABVD Who Converted to a Complete Response.|Conversion rate to Complete Response after brentuximab vedotin in patients with partial response at the end of ABVD therapy. Response criteria based on the International Workshop to standardize response criteria for malignant lymphomas. Complete Response is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. These nodes or masses should be selected according to all of the following: they should be clearly measurable in at least 2 perpendicular dimensions; if possible they should be from disparate regions of the body; and they should include mediastinal and retroperitoneal areas of disease whenever these sites are involved.|12 months|4 subjects had a partial response (PR) (Deauville score of 3)|||Participants|||Count of Participants
2660520|NCT01578967|Secondary|Number of Participant Who Achieved a Complete Response|Response criteria based on the International Workshop to standardize response criteria for malignant lymphomas. Complete Response is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.|12 months|One patient was not evaluable due to change in diagnosis during ABVD treatment (HL --> gray zone lymphoma). There was one death due to sepsis and hepatic failure, a very rare but known complication of brentuximab vedotin. Leaving 39 evaluable patients|||Participants|||Count of Participants
2660521|NCT01578967|Primary|Percentage of Patients With Positron Emission Tomography (PET) Negative Disease|"Percentage of patients who convert to PET negative disease post consolidation. This is defined by PET with Deauville <=2.~The Deauville 5-point scoring system is a five-point scoring system for the Fluorodeoxyglucose (FDG) avidity of a Hodgkin's lymphoma or Non-Hodgkin's lymphoma tumor mass as seen on FDG Positron emission tomography:~Score 1: No uptake above the background Score 2: Uptake ≤ mediastinum Score 3: Uptake > mediastinum but ≤ liver Score 4: Uptake moderately increased compared to the liver at any site Score 5: Uptake markedly increased compared to the liver at any site Score X: New areas of uptake unlikely to be related to lymphoma"|12 months|One patient was not evaluable due to change in diagnosis during ABVD treatment (HL --> gray zone lymphoma). There was one death due to sepsis and hepatic failure, a very rare but known complication of brentuximab vedotin. Leaving 39 evaluable patients|||Participants|||Count of Participants
2660522|NCT01578850|Secondary|Change in CRP and ESR at Each Visit During Period 2|The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||units on a scale||Standard Deviation|Mean
2660523|NCT01578850|Secondary|Change in CRP and ESR at Each Visit During Period 1|The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||units on a scale||Standard Deviation|Mean
2660524|NCT01578850|Secondary|Change in the Subject General Health VAS and Pain VAS at Each Visit During Period 2|"Participants were asked to answer the question In general how would you rate your health over the last 2-3 weeks? by marking a vertical line at the appropriate position through the 100 mm VAS. The length on the line was measured from the left (in mm). For Pain VAS, participants assessed the severity of their arthritis pain during the last 2 to 3 days using a 100 mm VAS by marking a vertical line at the appropriate position on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain."|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||units on a scale||Standard Deviation|Mean
2660525|NCT01578850|Secondary|Change in the Subject General Health Visual Analog Scale (VAS) and Pain VAS at Each Visit During Period 1|"Participants were asked to answer the question In general how would you rate your health over the last 2 3 weeks? by marking a vertical line at the appropriate position through the 100 mm VAS. The length on the line was measured from the left (in mm). For Pain VAS, participants assessed the severity of their arthritis pain during the last 2 to 3 days using a 100 mm VAS by marking a vertical line at the appropriate position on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain."|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||units on a scale||Standard Deviation|Mean
2660526|NCT01578850|Secondary|Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 2|Morning stiffness was defined as stiffness in and around the joints, lasting at least 1 hour before maximal improvement. Participants assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||minutes||Standard Deviation|Mean
2660527|NCT01578850|Secondary|Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 1|Morning stiffness was defined as stiffness in and around the joints, lasting at least 1 hour before maximal improvement. Participants assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||minutes||Standard Deviation|Mean
2660528|NCT01578850|Secondary|Change in the Subject Global Assessment of Arthritis in Period 2|Subjects assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||units on a scale||Standard Deviation|Mean
2660529|NCT01578850|Secondary|Change in the Subject Global Assessment of Arthritis in Period 1|Subjects assessed their overall disease activity over the last 2 to 3 days using a scale between 0 (no disease activity) and 10 (extreme disease activity), which corresponded to the magnitude of their pain) and marked one number with an 'X'.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||units on a scale||Standard Deviation|Mean
2660530|NCT01578850|Secondary|Change in the Physician Global Assessment of Arthritis at Each Visit During Period 2|The investigator estimated the subject's overall disease activity over the last 2 to 3 days (independent of the Subject Global Assessment of arthritis) using a scale between 0 (no disease activity) and 10 (extreme disease activity) and marking one number with an 'X'.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||units on a scale||Standard Deviation|Mean
2660531|NCT01578850|Secondary|Change in the Physician Global Assessment of Arthritis at Each Visit During Period 1|The investigator estimated the subject's overall disease activity over the last 2 to 3 days (independent of the Subject Global Assessment of arthritis) using a scale between 0 (no disease activity) and 10 (extreme disease activity) and marking one number with an 'X'.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||units on a scale||Standard Deviation|Mean
2660532|NCT01578850|Secondary|Change in the Tender and Swollen Joint Counts at Each Visit During Period 2 (Using 28 Joint Count as Well as 66/68 Joint Counts).|A total of 66 swollen and 68 tender joints were assessed for tenderness/pain and swelling by the same qualified personnel (when possible) at each visit. For ACR responses, a 66/68 joint count was used. For DAS28-ESR, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) calculations, the 28 joint count was used, which included: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||units on a scale||Standard Deviation|Mean
2660533|NCT01578850|Secondary|Change in the Tender and Swollen Joint Counts at Each Visit During Period 1 (Using 28 Joint Count as Well as 66/68 Joint Counts).|A total of 66 swollen and 68 tender joints were assessed for tenderness/pain and swelling by the same qualified personnel (when possible) at each visit. For ACR responses, a 66/68 joint count was used. For DAS28-ESR, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI) calculations, the 28 joint count was used, which included: shoulders, elbows, wrists, metacarpophalangeal (MCP) joints, proximal interphalangeal (PIP) joints, and knees.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||Units on a scale||Standard Deviation|Mean
2660534|NCT01578850|Secondary|Percentage of Participants Achieving ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 2 at Each Visit.|A 66 swollen and 68 tender joint count was used for calculating ACR responses. The ACR's definition for calculating improvement in RA (ACR20) was calculated as a 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: subject and physician global assessments of arthritis, pain, disability, and an acute phase reactant. Similarly, ACR50, ACR70 and ACR90 were calculated with the respective percent improvement. This efficacy measurement was made at every study visit.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||Percentage of participants|||Number
2660535|NCT01578850|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 1 at Each Visit.|A 66 swollen and 68 tender joint count was used for calculating ACR responses. The ACR's definition for calculating improvement in RA (ACR20) was calculated as a 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: subject and physician global assessments of arthritis, pain, disability, and an acute phase reactant. Similarly, ACR50, ACR70 and ACR90 were calculated with the respective percent improvement. This efficacy measurement was made at every study visit.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||percentage of participants|||Number
2660536|NCT01578850|Secondary|Change of CDAI and SDAI at Each Visit During Period 2|"SDAI and CDAI are defined as:~1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 2. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 2."|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||units on a scale||Standard Deviation|Mean
2660537|NCT01578850|Secondary|Change of CDAI and SDAI at Each Visit During Period 1.|"SDAI and CDAI are defined as:~1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 1. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 1."|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||units on a scale||Standard Deviation|Mean
2660538|NCT01578850|Secondary|Percentage of Participants Achieving LDA or Remission Based on CDAI and SDAI at Each Visit During Period 2.|"SDAI and CDAI are defined as:~1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 2. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 2."|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization|||Percentage of participants|||Number
2660539|NCT01578850|Secondary|Percentage of Participants Achieving LDA or Remission Based on Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) at Each Visit During Period 1.|"SDAI and CDAI are defined as:~1) SDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0-28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) + hs CRP (in mg/dL) in Period 1. 2) CDAI = DAS28 prorated Swollen Joint Count (0-28) + DAS28 prorated Tender Joint Count (0 28) + Physician Global Assessment of arthritis (0-10) + Subject Global Assessment of arthritis (0-10) in Period 1."|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||Percentage of participants|||Number
2660540|NCT01578850|Secondary|Percentage of Participants Achieving EULAR Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 2.|EULAR response is based on DAS28-ESR scores. The following good and moderate response is defined based on DAS28-ESR at endpoint (DAS28-ESR improvement at from Baseline in parenthesis): ≤3.2 units (>1.2 units) is good response; ≤3.2 units (0.6-1.2 units) are moderate response; ≤3.2 units (≤0.6 units) are no response.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||Percentage of participants|||Number
2660541|NCT01578850|Secondary|Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 1.|EULAR response is based on DAS28-ESR scores. The following good and moderate response is defined based on DAS28-ESR at endpoint (DAS28-ESR improvement at from Baseline in parenthesis): ≤3.2 units (>1.2 units) is good response; ≤3.2 units (0.6-1.2 units) are moderate response; ≤3.2 units (≤0.6 units) are no response.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||Percentage of participants|||Number
2660542|NCT01578850|Secondary|Percentage of Participants Who Had a Recurrence of Disease Symptoms During Period 2, Based on the Protocol Criteria|Flare is defined as the criteria of loss of LDA plus ≥0.6 unit worsening in DAS28-ESR score during period 2.|Baseline and Week 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||Percentage of participants|||Number
2660543|NCT01578850|Secondary|Change From Baseline in DAS28-CRP and DAS28-ESR in Period 2|The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 2. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||units on a scale||Standard Deviation|Mean
2660544|NCT01578850|Secondary|Change From Baseline in DAS28-CRP and DAS28-ESR in Period 1|The DAS assessment is a derived measurement with differential weight given to each component. The DAS28-ESR and DAS28-CRP was calculated at every visit within the clinical database in period 1. The components of the DAS28 ESR score assessment are: Tender/ Painful Joint Count (28), Swollen Joint Count (28); ESR, Subject General Health VAS assessment. The components of the DAS28 CRP score assessment were: Tender/Painful Joint Count (28); Swollen Joint Count (28), hsCRP, and the Subject General Health VAS assessment. This efficacy measurement was made at every study visit.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||units on a scale||Standard Deviation|Mean
2660545|NCT01578850|Secondary|Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2|Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 2 is presented below.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||Percentage of participants|||Number
2660546|NCT01578850|Secondary|Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 1|Proportion of participants who achieved remission (DAS28-ESR and DAS28-CRP at each visit during period 1 is presented below.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||Percentage of participants|||Number
2660547|NCT01578850|Secondary|Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2|Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 2 is presented below.|Baseline, Weeks 24, 28, 36, 44 and 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||Percentage of participants|||Number
2660548|NCT01578850|Secondary|Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-C-reactive Protein [CRP]) at Each Visit During Period 1|Proportion of participants who achieved LDA (DAS28-ESR and DAS28-CRP at each visit during period 1 is presented below.|Baseline, Weeks 4, 8, 16 and 24|The FAS for Period 1 (Open Label FAS) included all randomized participants who had at least one dose of open label study drug during Period 1 (ie, ETN or MTX).|||Percentage of participants|||Number
2660549|NCT01578850|Secondary|Percentage of Participants Who Remained in Remission at Week 52 (DAS28-ESR)|Proportion of participants who remained in Remission (DAS28-ESR <2.6) at Week 52.|Baseline and Week 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||Percentage of participants|||Number
2660550|NCT01578850|Primary|Percentage of Participants Who Remained in Low Disease Activity (LDA) (Disease Activity Score in 28 Joints-erythrocyte Sedimentation Rate [DAS28-ESR] <3.2) at Week 52.|Proportion of participants who remained in LDA DAS28-ESR <3.2 at Week 52 is presented below.|Baseline and Week 52|The FAS included all randomized participants who met the period 2 DAS28-ESR inclusion criteria, had at least one dose of study drug during Period 2 (ie, ETN, MTX or PBO) and had at least one valid efficacy (DAS28-ESR) evaluation after randomization.|||percentage of participants|||Number
2660551|NCT01578785|Secondary|Percent Change From Baseline to Month 12 (End of Placebo Controlled Period) in Brain Volume|Brain atrophy was defined by the percent brain volume change from baseline to Month 12|Day 1 up to Month 12|Intent to treat population was planned. However analysis was not performed due to early termination of the study.||||||
2660552|NCT01578785|Secondary|The Cumulative Number of Gadolinium-enhancing Lesions on T1-weighted Images Measured at Months 6 and 12 (End of Placebo Controlled Period)|Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.|Day 1 up to Month 12|Intent to treat population was planned. However analysis was not performed due to early termination of the study.||||||
2660553|NCT01578785|Secondary|The Cumulative Number of New or Enlarging T2 Lesions Measured at Months 6 and 12 (End of Placebo Controlled Period)|Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions.|Day 1 up to Month 12|Intent to treat population was planned. However analysis was not performed due to early termination of the study.||||||
2660554|NCT01578785|Primary|The Annualized Relapse Rate During the Placebo Controlled Period|The total number of confirmed relapses during the placebo-controlled phase is divided by the sum of the number of days on study in the placebo-controlled phase and then multiplied by the number of days in the year to calculate the annualized relapse rate.|Day 1 up to Month 12|Intent to treat population was planned. However analysis was not performed due to early termination of the study.||||||
2660555|NCT01578772|Primary|6-week Change in Maximum Relative Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy|Flow-mediated dilatation (FMD) testing of the brachial artery was performed for all participants on Telmisartan treatment at baseline and 6 weeks.|6 weeks (after baseline)||||percentage of maximum relative FMD||Inter-Quartile Range|Median
2660556|NCT01578772|Primary|6-week Change in Diameter and Flow Mediated Dilatation (FMD) of the Brachial Artery With Telmisartan Therapy|Flow-mediated dilatation (FMD) testing of the brachial artery was performed for all participants on Telmisartan treatment at baseline and 6 weeks.|6 weeks (after baseline)||||mm||Inter-Quartile Range|Median
2660557|NCT01578707|Other Pre-specified|Overall Response Rate (ORR) by Investigator|Overall response per the IWCLL 2008 criteria as assessed by Investigator with up to 6 years of study follow-up|From study initiation to study closure, including up to 6 years of study follow-up||||percentage of participants|||Number
2660558|NCT01578707|Other Pre-specified|Progression Free Survival (PFS) by Investigator With up to 6 Years of Study Follow-up|Long-Term Progression Free Survival as assessed by the investigator with up to 6 years of study follow-up|From study initiation to study closure, including up to 6 years of study follow-up||||months||95% Confidence Interval|Median
2660559|NCT01578707|Secondary|Rate of Sustained Hemoglobin and Platelet Improvement|Proportion of subjects with hemoglobin (HgB) increase >=20 g/L and platelet (PLT) increase >=50% over baseline continuously for >=56 days without blood transfusions or growth factors.|From study initiation to study closure, including up to 6 years of study follow-up||||percentage of participants|||Number
2660560|NCT01578707|Secondary|OS (Overall Survival)|OS analysis was conducted at the time of study closure, with no adjustment for crossover from the ofatumumab arm to the ibrutinib arm|OS analysis was conducted at the time of study closure, including up to 6 years of study follow-up||||months||95% Confidence Interval|Median
2660561|NCT01578707|Secondary|Overall Response Rate (ORR) by Independent Review Committee (IRC)|Overall Response Rate per the IWCLL 2008 criteria as assessed by IRC, limited to the time of primary analysis 06 November 2013|About 18 months after the first subject was enrolled||||percentage of participants|||Number
2660562|NCT01578707|Primary|PFS (Progression Free Survival) by Independent Review Committee (IRC), Limited to the Time of Primary Analysis 06 November 2013|The primary objective of this study was to evaluate the efficacy of ibrutinib compared to ofatumumab based on independent review committee (IRC) assessment of progression-free survival (PFS) according to 2008 IWCLL guidelines.|Analysis was conducted after observing approximately 117 PFS events, which occurred about 18 months after the first subject was enrolled.||||months||95% Confidence Interval|Median
2660563|NCT01578577|Secondary|Effects of These Strategies by Patients' Literacy Skills|"We will measure how the effects of the interventions vary based on the participants' literacy levels.~SBP at 12 months reported below."|Baseline, 3 months, 6 months,12 months||||mm Hg||Standard Deviation|Mean
2660564|NCT01578577|Secondary|Effectiveness of the Electronic Health Record-based Health Literacy Medication Therapy Management Strategy (EHMI), With and Without a Nurse Educator, Compared to Standard Care.|"This will be assessed by measuring patient medication understanding, medication reconciliation, adherence, and health outcomes (diastolic blood pressure, and among the diabetic subgroup Hemoglobin A1c <8.0 and LDL Cholesterol <100).~Reported here: HbA1c <8 at 12 months. Full secondary outcomes have been published. Persell SD, Karmali KN, MD, Lazar D, Friesema EM, Lee JY, Rademaker A, Kaiser D, Eder M, French DD, Brown T, Wolf MS. Effect of electronic health record-based medication support and nurse-led medication therapy management on hypertension and medication self-management: a randomized clinical trial. JAMA Intern Med. 2018;178:1069-1077."|Baseline, 3 months, 6 months, 12 months||||Participants|||Count of Participants
2660565|NCT01578577|Primary|Systolic Blood Pressure|The primary outcome is the systolic blood pressure measured approximately one year after the baseline interview is conducted.|one year||||mm Hg||Standard Deviation|Mean
2660566|NCT01578551|Secondary|Overall Survial|Number of months alive after 1 year of the combination of metformin with standard chemotherapy in patients with previously untreated advanced or metastatic pulmonary adenocarcinoma.|up to 2 years||||months||95% Confidence Interval|Median
2660567|NCT01578551|Secondary|Response to Therapy|Percentage of participants with complete or partial response to combination of metformin with standard chemotherapy in patients with previously untreated advanced or metastatic pulmonary adenocarcinoma as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1|2 years||||percentage of participants||95% Confidence Interval|Number
2660569|NCT01578499|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AEs and SAEs were assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.|First dose of study drug through 30 days after last dose of study drug (Up to 450 days)|The Safety population included participants who received at least one dose of study drug.|||participants|||Number
2660570|NCT01578499|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy General Questionnaire (FACT-G) Score|FACT-G is a 27-item general cancer QOL instrument completed by participants receiving cancer treatment. FACT-G incorporates a 7-day recall period and contains 4 primary subscales: Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28); Fact-G total score=sum of PWB, SWB, EWB, FWB, point range 0-108. Higher scores for the total scales and subscales indicate better quality of life. A negative change (reduction) from Baseline indicates improvement.|Day 1 of Cycles 1, 2, 4, 6, 8, 10, 12, 14, 16, at EOT and during posttreatment (LTFU) - (Median follow-up 38.8 months)|The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.|||score on a scale||Standard Deviation|Mean
2660571|NCT01578499|Secondary|Change From Baseline in the Skindex-29 Questionnaire Total Score|Skindex-29 is a 29-item dermatology-specific health-related quality of life (HRQoL). The Skindex-29 incorporates a 28-day recall period and consists of 3 domains: symptoms, emotions, and functioning. The domain scores and an overall score are expressed on a 100-point scale, 0 to 100 with higher scores indicating lower levels of health- HRQoL. A negative change (reduction) from Baseline indicates improvement.|Day 1 of Cycles 1, 2, 4, 6, 8, 10, 12, 14, 16, at End of Treatment (EOT) and during posttreatment long treatment follow-up (LTFU) - (Median follow-up 38.8 months)|The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.|||score on a scale||Standard Deviation|Mean
2660572|NCT01578499|Secondary|Number of Participants With Antitherapeutic Antibodies (ATA) to Brentuximab Vedotin|Blood was collected and evaluated for ATA and neutralizing ATA in all participants who received brentuximab vedotin to assess immunogenicity.|Baseline up to End of Treatment (Week 52)|The Safety population included participants who received at least one dose of study drug.|||participants|||Number
2660573|NCT01578499|Secondary|Ctrough: Observed Concentration at the End of a Dosing Interval for MMAE for Brentuximab Vedotin||Day 1 pre-dose of Cycles 2 and 4|The PK population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.|||ng/mL||Standard Deviation|Mean
2660574|NCT01578499|Secondary|Cmax: Maximum Observed Concentration for Monomethyl Auristatin (MMAE) for Brentuximab Vedotin||Day 1 pre-dose and 30 minutes after infusion ended in Cycles 1 and 3|The PK population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.|||ng/mL||Standard Deviation|Mean
2660575|NCT01578499|Secondary|Ctrough: Observed Concentration at the End of a Dosing Interval for Brentuximab Vedotin||Day 1 pre-dose of Cycles 2 and 4|The PK population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.|||ug/mL||Standard Deviation|Mean
2660576|NCT01578499|Secondary|Cmax: Maximum Observed Concentration for Brentuximab Vedotin||Day 1 pre-dose and 30 minutes after infusion in Cycles 1 and 3|The pharmacokinetic (PK) population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.|||ug/mL||Standard Deviation|Mean
2660577|NCT01578499|Secondary|Event-Free Survival (EFS)|EFS was assessed by the IRF and is defined as the time from randomization until any cause of treatment failure: disease progression, discontinuation of treatment for any reason, or death due to any cause, whichever occurs first. Disease progression was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).|From randomization until disease progression, death or data cutoff (Median follow-up 36.8 months)|The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.|||months||95% Confidence Interval|Median
2660578|NCT01578499|Secondary|DOR of Skin Response|Duration of skin response (CR and PR) was assessed by the investigator and is defined as the time between the first skin response to progressive disease in skin. Per mSWAT, CR is defined as 100% clearance of skin lesions. PR is defined as 50%-99% clearance of skin disease from Baseline; No new tumors in participants without tumors at Baseline -MF; No new tumors-primary cutaneous anaplastic large cell lymphoma (pcALCL).Progressive disease is defined as ≥ 25% increase in skin disease from baseline, or loss of response: in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score, or new tumors in participants without tumors at baseline (MF).|Until disease progression, death or data cutoff (Median follow-up 38.8 months)|The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Skin responders in ITT population were analyzed in this outcome measure.|||months||95% Confidence Interval|Median
2660613|NCT01577758|Primary|Cmax: Maximum Observed Serum Concentration for MLN0264|Maximum observed serum concentration (Cmax) is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve. Cmax is reported for the 1.8 mg/kg dose, which is the MTD, where there is adequate data to provide robust parameter information reliably.|Cycle 1: Day 1 pre-dose to Day 21 post-dose|Participants from the Pharmacokinetic (PK)-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameters.|||μg/mL||Full Range|Geometric Mean
2660579|NCT01578499|Secondary|Duration of Response (DOR)|Duration of response was assessed by the IRF in participants with confirmed response [CR or Partial Response (PR)] and is defined as the time between first documentation of response and disease progression. Response Criteria was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).|Until disease progression, death or data cutoff (Median follow-up 38.8 months)|The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Responders in ITT population were analyzed in this outcome measure.|||months||95% Confidence Interval|Median
2660580|NCT01578499|Secondary|Maximum Change From Baseline in Symptom Domain Score of the Skindex-29 Questionnaire|Skindex-29 is a 29-item dermatology-specific health-related quality of life (HRQoL). The Skindex-29 incorporates a 28-day recall period and consists of 3 domains: symptoms, emotions, and functioning. The domain scores and an overall score are expressed on a 100-point scale, from 0 to 100 with higher scores indicating lower levels of health- HRQoL. A negative change (reduction) from Baseline indicates improvement.|Baseline up to End of Treatment (Week 52)|The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Here number of participants analyzed are participants evaluable for this outcome measure.|||score on a scale||Standard Deviation|Mean
2660581|NCT01578499|Secondary|Progression-Free Survival (PFS)|PFS was assessed by the IRF and is defined as the time from randomization until disease progression or death due to any cause, whichever occurs first. Disease progression was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).|Until disease progression, death or data cutoff (Median PFS follow-up of 38.8 months)|The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.|||months||95% Confidence Interval|Median
2660582|NCT01578499|Secondary|Percentage of Participants Achieving a CR|Complete Response (CR) was determined by the IRF based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Response Criteria was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).|Each Cycle until disease progression, death or data cutoff (Median overall follow-up 38.8 months)|The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.|||percentage of participants||95% Confidence Interval|Number
2660583|NCT01578499|Primary|Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4)|ORR4 was determined by an Independent Review Facility (IRF) based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic assessment by an IRF and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Participants whose first response occurred after the start of subsequent anticancer therapy were excluded. Response Criteria was based on International Society for Cutaneous Lymphomas (ISCL), United States Cutaneous Lymphoma Consortium (USCLC) and Cutaneous Lymphoma Task Force (CLTF) of the European Organisation for Research and Treatment of Cancer (EORTC) Consensus guidelines (Olsen, 2011).|Each Cycle until disease progression, death End of treatment (Median overall follow-up 38.8 months)|The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.|||percentage of participants||95% Confidence Interval|Number
2660584|NCT01578486|Secondary|IL-6|IL-6 (interleukin 6) is a marker used to measure inflammation.|Baseline, week 12||||pg/mL||Standard Deviation|Mean
2660585|NCT01578486|Secondary|TNF-alpha|Tumor necrosis-alpha factor will be measured to assess inflammation levels.|Baseline,12 weeks||||pg/ml||Standard Deviation|Mean
2660586|NCT01578486|Secondary|Hs-CRP|High-sensitivity C-reactive protein (hs-CRP) will be measured in mg/L in order to detect inflammation. Higher hs-CRP values correspond to higher levels of inflammation.|Baseline, 12 weeks||||mg/L||Standard Error|Mean
2660587|NCT01578486|Primary|PANSS- Negative Score|Subscale of Positive and Negative Syndrome Scale that specifically measures negative symptoms. The scores range from 7-49, with higher scores representing a worse outcome.|Baseline, 12 weeks||||units on a scale||Standard Deviation|Mean
2660588|NCT01578486|Primary|PANSS Positive Score|Subscale of Positive and Negative Syndrome Scale that specifically measures positive symptoms. The scores range from 7-49, with higher scores representing a worse outcome.|Baseline, 12 weeks||||units on a scale||Standard Deviation|Mean
2660589|NCT01578486|Primary|MATRICS Composite Score|Improved cognition will be measured using the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) assessment. The MATRICS assessment includes a battery of tests, and the composite t-score measures cognition across 7 domains including speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. A higher score indicates better cognition.|Baseline, 12 weeks||||t-score||Standard Deviation|Mean
2660590|NCT01578486|Primary|SANS Total Score|Negative symptoms of schizophrenia will be measured by total score on the Scale for Assessment of Negative Symptoms (SANS; score range 0-100). Higher scores correspond with worse outcomes.|Baseline, 12 weeks||||units on a scale||Standard Deviation|Mean
2660591|NCT01578486|Primary|PANSS Total Score|Positive and negative symptoms of schizophrenia will be measured by total score on all subscales of the Positive and Negative Syndrome Scale (PANSS; score range 30-210). Higher scores correspond with worse outcomes.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2660612|NCT01577758|Primary|Cmax: Maximum Observed Plasma Concentration for Monomethyl Auristatin E (MMAE)|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Cmax is reported for the 1.8 mg/kg dose, which is the MTD, where there is adequate data to provide robust parameter information reliably.|Cycle 1: Day 1 pre-dose to Day 21 post-dose|Participants from the Pharmacokinetic (PK)-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameters.|||ng/mL||Full Range|Geometric Mean
2660614|NCT01577758|Secondary|Number of Participants With Antitherapeutic Antibodies (ATA)|Blood was collected and sent to a laboratory to determine the immunogenicity, whether binding antibodies to MLN0264 were present (ATA development).|Day 1 of every 21 days cycle and at End of study (EOS) approximately 9 months||||participants|||Number
2660592|NCT01578330|Secondary|Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|Month 12|Per Protocol Population: included all patients who had evaluable data for the primary variable from first to last visit|||score on scale||Standard Deviation|Mean
2660593|NCT01578330|Secondary|Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|Month 6|Per Protocol Population: included all patients who had evaluable data for the primary variable from first to last visit|||score on scale||Standard Deviation|Mean
2660594|NCT01578330|Secondary|Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36).|The SF-36v2 is a validated health-related quality of life instrument used in numerous disease states, including MS. It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Additionally, two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). If half or more questions within a domain were answered, then a score was calculated for that domain. Otherwise, the patient score for that domain was set to missing. If the patient was missing any 1 of the 8 scale scores, then the physical and mental component scores were set to missing. An algorithm was used to create a score from 0 to 100 for each domain score and component score. A positive change from baseline indicates improvement.|Month 1|Per Protocol Population: included all patients who had evaluable data for the primary variable from first to last visit|||score on scale||Standard Deviation|Mean
2660595|NCT01578330|Primary|Mean Patient-Reported Treatment Satisfaction Questionnaire for Medication Scores (TSQM-9)|The Treatment Satisfaction Questionnaire for Medication (TSQM-9) is a psychometric measure of a patient's satisfaction with medication. It consists of 3 subscales: effectiveness, convenience and global satisfaction. The scores were computed by adding items for each domain, i.e. 1 to 3 for effectiveness, 4 - 6 for convenience and 7 to 9 for global satisfaction. The lowest possible score (1 for each item and 3 for all 3 subscales) was subtracted from the composite score and divided by the greatest possible score range. The greatest range was (7-1) X 3 items = 18 for the effectiveness and convenience, and (5-1) x 3 items = 12 for global satisfaction. This provided a transformed score between 0 and 1 that was then multiplied by 100. A positive change from baseline indicates improvement.|Baseline and month 12|Per Protocol Population: included all patients who had evaluable data for the primary variable from first to last visit|||Scores on a scale||Standard Deviation|Mean
2660596|NCT01578317|Primary|Flu Antibody Titers|Flu Antibody titers at days 0, 21, 42, 100. Antibody-neutralization titers by microneutralization were measured against five different H5N1 virus strains (i.e., A/Vietnam/1194/2004 (clade 1), A/Indonesia/5/2005 (clade 2.1), A/Turkey/15/2006 (clade 2.2), A/Egypt/3072/2010 (clade 2.2), and A/Anhui/1/2005 (clade 2.3.4)) at day 0 (prevaccination), day 21 (post first vaccination), day 42 (post second vaccination) and day 100 postvaccination for AS03-adjuvanted group and unadjuvanted group. Sera were tested at an initial dilution of 1:20, and those that were negative (<1:20) were assigned a titer of 10.|Days 0, 21, 42, and 100||||Titers||Standard Deviation|Geometric Mean
2660597|NCT01578239|Other Pre-specified|Exploratory Objectives|• To explore the correlation of toxicity outcomes and administered radioactivity corrected for body weight and body surface area; • To explore the correlation of clinical efficacy outcomes with the levels of the biomarkers Chromogranin-A (CgA) in the serum and 5-Hydroxyindoleacetic acid (5-HIAA) in the urine; • To evaluate dosimetry, pharmacokinetics (PK) and ECG in a subset of 20 patients; • To explore the correlation of clinical efficacy outcomes with OctreoScan® tumour uptake score; • To explore the correlation of clinical outcomes with serum levels of Alkaline Phosphatase (AP): • To evaluate the Duration of Response (DoR) in the two study arms; • To evaluate the Time to Second Progression (PFS2) in the two study arms|Study Treatment Phase|||||||
2660598|NCT01578239|Secondary|Long-term Safety and Efficacy Assessment|Any progressive patient ceases treatment/assessment and proceeds to long-term follow-up assessment. Any non-progressive patients continues treatment/assessments until the PFS Primary End-Point, then: a. Patients who have 76week or more treatment/assessment stop treatment but continue the long-term follow-up assessments for 5 years overall from the date of randomization of the last randomized. b. Remaining randomized patients continue in the fixed 76-week treatment/assessment phase unless progression occurs, then proceed to the long-term follow-up assessment phase for 5 years overall from the date of randomization of the last randomized patient. During the long-term follow-up assessment phase, toxicities suspected in relation with the study drug (including haematology, biochemistry, urine analyses), anti-tumour treatment administered after progression/discontinuation, disease status based on local CT/MRI assessment, and OS data will be collected every 6 months.|Every 6 months for a period of up to 5 years after the end of the study|||||||
2668032|NCT01509677|Secondary|Change From V1 to V5 in Absolute Cell Count in Induced Sputum (10^6 Neutrophils/mL): Between-Treatment Difference||Baseline to 14 weeks||||10^6 neutrophils/mL||Standard Error|Least Squares Mean
2660599|NCT01578239|Secondary|Safety Assessments (Adverse Events, Laboratory Parameters, Cancer Related Symptoms, Physical Examination, Vital Signs, Karnofsky Performance Status, ECG)|The following parameters will be monitored: - Changes from Baseline in Hematology (WBC, platelets, haemoglobin, MCV), Blood chemistry (BUN, serum creatinine and creatinine clearance, uric acid, albumin, total bilirubin, AP, aspartate aminotransferase [AST/ASAT], alanine aminotransferase [ALT/ALAT], gamma-glutamyl transferase [γ-GT], [Na], [K], lactic dehydrogenase [LDH], glycosylated hemoglobin/hemoglobin A1c [glycoHb], free thyroxine [fT4]) and Urinalysis (RBC/hpf, WBC/hpf, casts/lpf, protein, 5-HIAA), - Cancer related symptoms, - Physical Examination, including heart rate, blood pressure and weight, - Karnofsky Performance Status, - ECG intervals. All AEs and SAEs reported (spontaneously or not) by the patient will be collected during the study.|Data for this outcome measure are posted in the Adverse Events section below. Adverse Events table includes all treatment emergent adverse events collected from date of first enrollment (10 Jul 2012) to 30 June 2016.|||||||
2660600|NCT01578239|Primary|Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. CT/MRI tumour assessment in both arms are performed every 12±1 weeks from the first treatment date.|after 74 centrally confirmed cases disease progression or death|Full analysis data set|||months||95% Confidence Interval|Median
2660601|NCT01578187|Primary|Percentage of Participants Performing Critical/Non-critical Errors|"Study staff will record the number of errors according to the following:~Critical error: an error that may cause a serious adverse event or an adverse event from a single occurrence~Non critical error: An error that, if repeated without correction/intervention, may cause an adverse event."|1-2 hours|Subjects who were not self-excluders in the label comprehension phase and consented to continue to the usability phase (product use).|||percentage of participants with errors|||Number
2660602|NCT01578187|Primary|Percent of Participants Correctly Determining Eligibility for Use of the Device (Responders)|"Label comprehension will be based on responses to a questionnaire. Questions will be based on a tiered system by level of importance in responding correctly according to the following:~Questions regarding safe use of the system.~Questions regarding correct use of the system(not related to safety).~In order to demonstrate how well the label instruction, as a whole, was understood by all subjects, the proportion of subjects who correctly understood the label as a whole was calculated by classifying each subject as either a responder or non-responder based on the following criteria regarding all questions:~A subject was considered a responder if he/she correctly answered 11/12 questions related to safety AND 5/6 low category questions not related to safety.~The study was considered a success if the response rate (i.e., the proportion of subjects correctly understanding the label based on the responder criteria) was at least 90%."|1 hour|Sample size was discussed with the FDA during a pre-IDE teleconference|||percentage of participants|||Number
2660603|NCT01578044|Primary|Gaps Days Between Prescription Refills for Dabigatran, Rivaroxaban, and Apixaban|The investigators will calculate the # of gap days between refills for dabigatran/rivaroxaban/apixaban for each3 and 6 months of the pilot intervention. This will be based on pharmacy refill data and calculated using the date dabigatran/rivaroxaban/apixaban was dispensed and the # of days supplied for that prescription. We will add the # of gap days for each 3 and 6 months of the pilot for each patient, and compare the total # of gaps days between intervention and usual care patients. The gap days between refills is a validated measure of adherence and identifies patients with sub-optimal adherence.A negative gap day value indicates that participants received the refill prior to completion of the previous prescription.|3 and 6 months||||days|||Number
2660604|NCT01578031|Secondary|Change From Baseline in Oxidative Stress|Overnight urinary excretion of 8-isoprostane.|4 months|Data were not collected.||||||
2660605|NCT01578031|Secondary|Change From Baseline in Circulating Inflammatory Biomarker|Change from Baseline in Circulating Inflammatory Biomarker: IL-6.|4 months|These numbers reflect the overall number of participants who completed 4 months of CPAP treatment (i.e., the completer’s analysis) and have complete data for this outcome.|||pg/mL||Standard Deviation|Mean
2660606|NCT01578031|Secondary|Change From Baseline in Sympathetic Nervous System Activity|Change from Baseline in Sympathetic Nervous System Activity as measured by 24-hour urine collection for norepinephrine levels.|4 months|These numbers reflect the overall number of participants who completed 4 months of CPAP treatment (i.e., the completer’s analysis) and have complete data for this outcome.|||mcg/24 hours||Standard Deviation|Mean
2660607|NCT01578031|Secondary|Change From Baseline in Psychomotor Vigilance Task|Change from Baseline in Psychomotor Vigilance Task as measured by number of lapses during 10-minute Reaction time test.|4 months|These numbers reflect the overall number of participants who completed 4 months of CPAP treatment (i.e., the completer’s analysis) and have complete data for this outcome.|||lapses||Standard Deviation|Mean
2660608|NCT01578031|Primary|Change From Baseline in Mean Arterial Blood Pressure|Change in mean 24-hour ambulatory blood pressure from baseline following 4-months of PAP treatment|4 months|These numbers reflect the overall number of participants who completed 4 months of CPAP treatment (i.e., the completer’s analysis) and have complete data for this outcome.|||mm Hg||Inter-Quartile Range|Mean
2660609|NCT01577966|Primary|Percent Decrease in Central Nervous System Bioavailability of Sulfasalazine|To determine the ability of sulfasalazine to alter glioma glutamate levels. These levels will be measured by Magnetic Resonance Spectroscopy (MRS). The percent change is noted per subject. The measure is a % decrease of glioma glutamate levels|up to 2 years post baseline||||percentage of change|||Number
2660610|NCT01577758|Primary|AUC0-21 Days: Area Under the Curve Day 0 to Day 21 for MMAE|Area under the plasma drug concentration versus time curve from time 0 to Day 21. AUC0-21 is reported for the 1.8 mg/kg dose (the MTD), where there is adequate data to provide robust parameter information reliably.|Cycle 1: Day 1 pre-dose to 21 Days post-dose|Participants from the PK-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameter AUC0-21 days.|||day*ng/mL||Full Range|Geometric Mean
2660611|NCT01577758|Primary|AUC0-21 Days: Area Under the Curve Day 0 to Day 21 for MLN0246|Area under the drug concentration versus time curve from time 0 to Day 21. AUC0-21 is reported for the 1.8 mg/kg dose (the MTD), where there is adequate data to provide robust parameter information reliably.|Cycle 1: Day 1 pre-dose to 21 Days post-dose|Participants from the PK-evaluable Population, all participants with sufficient dosing and reliable PK data to estimate PK parameters.|||day*μg/mL||Full Range|Geometric Mean
2660615|NCT01577758|Secondary|Best Overall Response|"The percentage of participants in each best overall response category, was determined using the Modified Response Evaluation Criteria in Solid Tumors (RECIST).~Complete Response: Disappearance of all target lesions and all non-target lesions and normalization of tumor marker level.~Partial Response: At least a 30% decrease in the sum of the Longest Diameter (LD) of target lesions, taking as reference the baseline sum LD.~Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the start or the appearance of one or more new lesions. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.~Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits."|At the completion of every second cycle up to 12 cycles (approximately 9 months). Each cycle is a 21 days cycle|Response Evaluable Population is defined as patients with measureable disease who receive any amount of MLN0264 and have at least 1 post-Baseline response assessment.|||percentage of participants|||Number
2660616|NCT01577758|Primary|Maximum Tolerated Dose (MTD) of MLN0264|MTD of MLN0264 was determined. Decisions regarding dose escalation were made based on any DLT that occurred during the first cycle of treatment.|Every 3 weeks until MTD is established, approximately 9 months|DLT evaluable Population: participants enrolled in the Dose Escalation phase of the study who either experienced a DLT during Cycle 1 or received a scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT.|||mg/kg|||Number
2660617|NCT01577758|Primary|Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events|"An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.~A Serious Adverse Event (SAE) was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.~A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug."|From the time informed consent is signed through 30 days after the last dose of study drug, approximately 9 months|Safety Analysis Set included all participants who received at least one dose of study drug.|||participants|||Number
2660618|NCT01577758|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|"DLT was defined as any of the following Adverse Events (AEs) that occur and are considered by the investigator to be related to therapy.~Grade 4 neutropenia (Absolute Neutrophil Count < 500 cells/mm^3).~Grade 3 or greater neutropenia with fever and/or infection.~Grade 4 thrombocytopenia (platelets < 25,000/mm^3).~Grade 3 or greater thrombocytopenia with clinically meaningful bleeding at any time.~Grade 3 or greater nausea and/or emesis that occurs despite of prophylaxis.~Grade 3 or greater diarrhea that occurs despite supportive care.~Any other Grade 3 or greater non-hematological toxicity other than Grade 3 fatigue or Grade 3 Alopecia.~Inability to start the next cycle of therapy due to treatment delay of more than 2 weeks because of lack of recovery.~Other MLN0264-related non-hematologic toxicities Grade 2 or greater requiring discontinuation of therapy."|From the time informed consent is signed through 30 days after the last dose of study drug, approximately 9 months|DLT evaluable Population: participants enrolled in the Dose Escalation phase of the study who either experienced a DLT during Cycle 1 or received a scheduled Cycle 1 dose and completed all study procedures in Cycle 1 without DLT.|||participants|||Number
2660619|NCT01577745|Secondary|Overall Survival|Overall survival defined as the time from the first dose of MEDI0639 until death due to any cause. OS (months) = (Date of death or censoring - Date of the first dose of MEDI0639 + 1) / (365.25/12).|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639.|||Months||95% Confidence Interval|Median
2660620|NCT01577745|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) is defined as the time from the first dose of MEDI0639 until the first documentation of disease progression or death due to any cause, whichever occurs first. PFS (months) = (Date of PD/death or censoring - Date of the first dose of MEDI0639 + 1) / (365.25/12).|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639.|||Months||95% Confidence Interval|Median
2660621|NCT01577745|Secondary|Duration of Response (DR)|DR defined as time from start of first documented objective response [confirmed Complete Response (CR) or confirmed Partial Response (PR)] to first documented disease progression or death due to any cause, whichever occurs first. DR calculated as (months) = (Date of PD/death or censoring - Date of first disease response + 1)/ (365.25/12).|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639. All participants with an objective response were included.|||Months||95% Confidence Interval|Median
2660622|NCT01577745|Secondary|Time to Response|Time to response (TTR) defined as the time from the first dose of MEDI0639 until the first documentation of a subsequently confirmed objective response. Only participants who have achieved objective response (confirmed CR or confirmed PR) was evaluated for TTR. TTR (months) = (Date of first disease response - Date of the first dose of MEDI0639 + 1) / (365.25/12).|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639. All participants with an objective response were included.|||Months||95% Confidence Interval|Median
2660623|NCT01577745|Secondary|Percentage of Participants With Disease Control|Disease control rate (DCR) defined as the percentage of participants with a BOR of confirmed CR, confirmed PR or SD.|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639.|||Percentage of Participants||95% Confidence Interval|Number
2660624|NCT01577745|Secondary|Percentage of Participants With Objective Response|Objective response rate (ORR) defined as the percentage of participants with a BOR of confirmed CR or confirmed PR.|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639. All participants with an objective response were included.|||Percentage of Participants||95% Confidence Interval|Number
2660625|NCT01577745|Secondary|Percentage of Participants With Best Overall Response|Percentage (%) of participants who were responders with BOR documented as confirmed CR, PR, stable disease (SD), progressive disease (PD) and non-evaluable (NE). CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. PR: At least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|From study entry through the end of the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639.|||Percentage of Participants|||Number
2660626|NCT01577745|Secondary|Number of Participants Positive With Antidrug Antibodies (ADA) for MEDI0639|Blood samples were measured for the presence of ADA for MEDI0639 using a validated bridging immunoassay. Only the number of participants positive for anti-MEDI-575 antibodies at any visit were presented.|On Day 1 of Cycles 1, 2, 3, and every other cycle thereafter, end of treatment, 30 days, and 3 and 6 months after the last dose of MEDI0639. Maximum time frame across participants was 14 months.|All participants who received any treatment with MEDI0639.|||Participants|||Number
2660627|NCT01577745|Secondary|Half-life (t1/2) After Cycle 1 Treatment Administration of MEDI0639|The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639.|Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1|All the participants who received dose of MEDI0639 in Cycle 1 and for whom PK blood samples were collected and evaluated.|||Days||Standard Deviation|Mean
2660628|NCT01577745|Secondary|Clearance (CL) After Cycle 1 Treatment Administration of MEDI0639|The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639. Clearance was estimated as dose divided by the area under serum concentration-time curve from time zero to infinity.|Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1|All the participants who received dose of MEDI0639 in Cycle 1 and for whom PK blood samples were collected and evaluated.|||Liter per day (L/d)||Standard Deviation|Mean
2660629|NCT01577745|Secondary|Maximum Observed Concentration (Cmax) After Cycle 1 Treatment Administration of MEDI0639|The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639.|Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1|All the participants who received dose of MEDI0639 in Cycle 1 and for whom PK blood samples were collected and evaluated.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2660630|NCT01577745|Secondary|Area Under the Concentration‑Time Curve From Time 0 to Infinity (AUCinf) After Cycle 1 Treatment Administration of MEDI0639|The pharmacokinetics (PK) parameter was estimated using the noncompartmental analysis methods, based on the individual serum concentration-time data. The concentration-time curve is the result of blood sampling at specified time points and its measured concentration of MEDI0639.|Days 1 (prior to start of infusion and 30 mins, 2, and 6 hours post end of infusion), 2, 5 , 8, and 15 of Cycle 1|All the participants who received dose of MEDI0639 in Cycle 1 and for whom Pharmacokinetic (PK) blood samples were collected and evaluated.|||microgram*day per milliliter (mcg*d/mL)||Standard Deviation|Mean
2660631|NCT01577745|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Echocardiogram Evaluations|Echocardiogram parameters included left ventricular ejection fraction (LVEF) and pulmonary arterial pressure (PAP). The TEAEs related to echocardiogram evaluations in participants were reported.|From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.|All participants who received at least one dose of MEDI0639.|||Participants|||Number
2660632|NCT01577745|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (ECG) Evaluations|ECG parameters included QT interval and corrected QT (QTc) interval. Electrocardiogram (ECG) parameters were assessed at baseline as well as throughout the study. All 12-lead ECGs performed during the study were obtained in triplicate. The TEAEs related to ECG evaluations in participants were reported.|From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.|All participants who received at least one dose of MEDI0639.|||Participants|||Number
2660633|NCT01577745|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs and Physical Examination|Vital signs (temperature, blood pressure, pulse rate, and respiratory rate) were performed at baseline and throughout the study. The TEAEs related to vital signs in participants were reported.|From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.|All participants who received at least one dose of MEDI0639.|||Participants|||Number
2660634|NCT01577745|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Laboratory Parameters|Laboratory evaluations of blood and urine samples were performed, including hematology (white blood cell [WBC] count with differential, red blood cell [RBC] count, hematocrit, hemoglobin, platelet count, mean corpuscular volume [MCV], and mean corpuscular hemoglobin concentration [MCHC]); serum chemistry (calcium, chloride, magnesium, potassium, sodium, bicarbonate, aspartate transaminase [AST], alanine transaminase [ALT], alkaline phosphatase, total bilirubin, liver function test, gamma glutamyl transferase [GGT], lactate dehydrogenase, uric acid, creatinine, blood urea nitrogen [BUN], glucose, albumin, total protein, triglycerides, cholesterol, and troponin); and routine urinalysis. The TEAEs related to laboratory evaluations in participants were reported.|From the first dose of MEDI0639 until 90 days after last dose of MEDI0639. Maximum time frame across participants was 11 months.|All participants who received at least one dose of MEDI0639.|||Participants|||Number
2660635|NCT01577745|Primary|Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs)|A serious AE (SAE) is any AE that results in death (refers to an event, which risk of death at the time of the event; it does not refer to an event that may have led to death), is immediately life threatening, require (or prolong) inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. Treatment-emergent SAEs defined as SAEs present at baseline that worsened in intensity after administration of study drug or SAEs absent at baseline that emerged after administration of study drug. The SAEs were summarized using MedDRA version 18.1.|From the first dose of MEDI0639 until the end of participation in the study. Maximum time frame across participants was 4 years.|All participants who received at least one dose of MEDI0639.|||Participants|||Number
2660636|NCT01577745|Primary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. Treatment-emergent AEs (TEAEs) were events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug, for the period extending to 90 days after the last dose of study drug. The AEs were summarized using Medical Dictionary for Regulatory Activities (MedDRA) version 18.1.|From the first dose of MEDI0639 until 90 days after the last dose of MEDI0639. Maximum time frame across participants was 11 months.|All participants who received at least one dose of MEDI0639.|||participants|||Number
2660637|NCT01577745|Primary|Maximum Tolerated Dose (MTD) of MEDI0639|The MTD evaluation was based on the dose-limiting toxicity (DLT) evaluable population. DLT is defined as any Grade 3 or higher treatment-related toxicity that occurred during the DLT evaluation period (defined as the time from the first dose of MEDI0639 to 21 days after the first dose), except for National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 hypertension that could be controlled within 96 hours; Grade 3 symptomatic hypertension of greater than (>) 180 millimetre of mercury (mm Hg) systolic or >120 mm Hg diastolic or asymptomatic hypertension of >200 mm Hg systolic or >120 mm Hg diastolic was considered a DLT.|From the first dose of MEDI0639 to 21 days after the first dose|All participants enrolled in the dose-escalation phase who received at least 1 full cycle of MEDI0639 and completed safety follow-up through the DLT evaluation period or experienced any DLT.|||milligram (mg)|||Number
2660638|NCT01577732|Primary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Days 0-30).|Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.|||Participants|||Count of Participants
2660639|NCT01577732|Primary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination.|Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.|||Participants|||Count of Participants
2660640|NCT01577732|Primary|Number of Subjects Reporting Solicited General Symptoms|Solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss of Appetite and Fever, defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C). Any = occurrence of a general symptom regardless of intensity grade or relationship to study vaccination.|Within the 4-day (Days 0-3) follow up period after vaccination.|Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.|||Participants|||Count of Participants
2660641|NCT01577732|Primary|Number of Subjects Reporting Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|Within the 4-day (Days 0-3) follow up period after vaccination.|Analyses were performed on the Total Vaccinated cohort, which included all the subjects with documented administration of the study vaccine.|||Participants|||Count of Participants
2660642|NCT01577706|Primary|Right Temporal: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.~GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)|One participant is missing GABA level at t4 while on Dextroamphetamine. Another participant is missing GABA levels both at t2 and t4 while on Dextroamphetamine. Another participant is missing GABA levels at both t2 and t4 while on Alprazolam.|||percent change||Inter-Quartile Range|Median
2660643|NCT01577706|Primary|Right Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.~GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)|One participant is missing GABA level at t4 while on Dextroamphetamine.|||percent change||Inter-Quartile Range|Median
2660658|NCT01577628|Primary|Proportion of Infants Who Develop Atopic Dermatitis|Proportion of infants who develop atopic dermatitis at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
2660644|NCT01577706|Primary|Right Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.~GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)|One participant ismissing GABA level at t4 while on Dextroamphetamine|||percent change||Inter-Quartile Range|Median
2660645|NCT01577706|Primary|Parieto-Occipital: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.~GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)||||percent change||Inter-Quartile Range|Median
2660646|NCT01577706|Primary|Left Temporal: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.~GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)|One participant is missing GABA level at t4 while on Placebo, and one participant is missing GABA level at t2 while on Alprazolam.|||percent change||Inter-Quartile Range|Median
2660647|NCT01577706|Primary|Left Basal-Ganglia: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.~GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)||||percent change||Inter-Quartile Range|Median
2660648|NCT01577706|Primary|Left Thalamus: Percent Change in GABA Levels After an Acute Drug Challenge|"The primary goal of this study is to assess the efficacy of an advanced spectroscopic imaging protocol in detecting changes in the levels of brain GABA in response to an acute drug challenge.~GABA levels are expressed as a ratio to total creatinine: GABA/Cr percent change = 100*(later timepoint - earlier timepoint) / earlier timepoint"|from 45 minutes post-dose to 102 minutes post-dose in 19-minute intervals (4 time points at t1: 45, t2: 64, t3: 83, t4: 102 minutes post-dose)||||percent change||Inter-Quartile Range|Median
2660649|NCT01577628|Secondary|Time of Onset of Atopic Dermatitis|Time of onset of atopic dermatitis in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
2660650|NCT01577628|Secondary|Adverse Events (AEs) Collection|Adverse events (Skin AEs, asthma, food allergies, allergic rhinitis and any AE related to Lipikar Syndet, Lipikar Balm AP (group 1) or any other moisturizer application (group 2) will be collected.|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
2660651|NCT01577628|Secondary|Time of Onset of Food Allergy in Infants|Time of onset of food allergy in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
2660652|NCT01577628|Secondary|Time of Onset of Asthma in Infants|Time of onset of asthma in infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
2660653|NCT01577628|Secondary|Influence of the Presence of Mutation in the Filaggrin Gene on the Proportion of Infants Who Develop a Food Allergy|Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop a food allergy at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
2660654|NCT01577628|Secondary|Influence of the Presence of Mutation in the Filaggrin Gene on the Proportion of Infants Who Develop Asthma|Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop asthma at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
2660655|NCT01577628|Secondary|Influence of the Presence of Mutation in the Filaggrin Gene on the Proportion of Infants Who Develop Atopic Dermatitis|Influence of the presence of mutation in the filaggrin gene on the proportion of infants who develop atopic dermatitis at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
2660656|NCT01577628|Secondary|Proportion of Infants Who Develop a Food Allergy|Proportion of infants who develop a food allergy at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
2660657|NCT01577628|Secondary|Proportion of Infants Who Develop Asthma|Proportion of infants who develop asthma at two years for infants randomized to Lipikar Balm AP as compared to infants randomized to the no intervention control group|2 years|Subjects were not randomized to either treatment prior to study termination and therefore no data was collected for this Outcome Measure||||||
2660659|NCT01577537|Secondary|Adverse Events Potentially Related to Treatment|Number of participants experiencing adverse events considered potentially related to study treatment.|Screening/baseline through TOC visit, Day 1-30|Safety population. Two participants of those randomized to the 1% SPL7013 Gel group withdrew consent, did not use study medication, and therefore were not included in the Safety population.|||Participants|||Count of Participants
2660660|NCT01577537|Secondary|Number of Women With Nugent Cure at the TOC Visit|Nugent Cure is defined as a Nugent score of 0-3 (normal)|Day 21-30|mITT|||Participants|||Count of Participants
2660661|NCT01577537|Secondary|Number of Women With Clinical Cure at the Test of Cure Visit (TOC)|Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)|Day 21-30|mITT|||Participants|||Count of Participants
2660662|NCT01577537|Secondary|Number of Women With Nugent Cure at the EOT Visit|Nugent Cure is defined as a Nugent score of 0-3 (normal)|Day 9-12|mITT|||Participants|||Count of Participants
2660663|NCT01577537|Primary|Number of Women With Clinical Cure at the End of Treatment Visit (EOT)|Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)|Day 9-12|mITT|||Participants|||Count of Participants
2660664|NCT01577381|Secondary|Change From Baseline in Amyloid Beta (A-Beta) 1-42 Plasma Concentration at End of Study (Day 449)|Concentration of amino acid peptide, known as A-Beta 1-42, in plasma.|Baseline, Day 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660665|NCT01577381|Secondary|Change From Baseline in Amyloid Beta (A-Beta) 1-40 Plasma Concentration at End of Study (Day 449)|Concentration of amino acid peptide, known as A-Beta 1-40, in plasma.|Baseline, Day 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660666|NCT01577381|Secondary|Change From Baseline in Total Amyloid Beta (A-Beta) 1-x Plasma Concentration at End of Study (Day 449)|Concentration of total amino acid peptide, known as A-Beta 1-x, in plasma.|Baseline, Day 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660667|NCT01577381|Secondary|Plasma Population PK Parameters|Population PK parameters were to be evaluated for Cmax, AUCt, Cmin, CLss, and Rac for AUCt between the first and last (11th) doses.|Days 1, 28, 57, 85, 169, 253, 281, 309, 337 and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660668|NCT01577381|Secondary|Accumulation Ratio (Rac) for AUCt||Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660669|NCT01577381|Secondary|Clearance at Steady State (CLss)|Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug (R0/Css)|Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660670|NCT01577381|Secondary|Area Under the Concentration-Time Curve From Time Zero Until Last Sampling Time (AUCt)||Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660671|NCT01577381|Secondary|Minimum Observed Plasma Trough Concentration (Cmin)||Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660672|NCT01577381|Secondary|Maximum Observed Plasma Concentration (Cmax)||Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660673|NCT01577381|Secondary|Number of Participants With Treatment-Related TEAEs|An AE was an untoward medical occurrence in a participant who received study drug without regard to causal relationship. An investigator's relationship assessment is the determination of whether there exists a reasonable possibility that the investigational product caused or contributed to an AE.|Days 28, 57, 85, 113, 141 and 169|The safety analysis set included all participants who received at least one dose of study product.|||Participants|||Number
2660695|NCT01577381|Primary|Mean Reduction (in Study Eye) in Rate of Growth of GA at Day 449 (End of Study)|GA is the advanced form of dry AMD. The reduction in GA area in the study eye was based on FAF at end of study (Day 449).|Baseline and Day 449|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660674|NCT01577381|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to Seriousness|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Days 28, 57, 85, 113, 141 and 169|The safety analysis set included all participants who received at least 1 dose of study drug.|||Participants|||Number
2660675|NCT01577381|Secondary|Number of Participants With Positive Anti-Drug Antibody (ADA)|The number of participants with positive ADA was to be summarized for each treatment arm.|Day 57 and Day 169|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660676|NCT01577381|Secondary|Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings|Clinically significant ECG findings include: corrected QT (QTc) > 450 msec, QTc >500 msec, change in QTc between 30 and 60 msec, change in QTc greater than or equal to 60 msec.|Days 28, 57, 85, 113 and 169|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660677|NCT01577381|Secondary|Number of Participants With Abnormal Change From Baseline in Vital Signs|Vital sign assessments include: supine systolic and diastolic blood pressure, pulse rate and body temperature.|Screening, Days 28, 57, 85, 113, 141, and 169|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660678|NCT01577381|Secondary|Number of Participants With Treatment-Emergent Laboratory Abnormalities|Laboratory assessments include: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); coagulation assessments.|Day 85 and Day 169|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660679|NCT01577381|Secondary|Change From Placebo in Critical Print Size Reading at 9, 12, 15 Months and End of Study|The critical print size is the smallest print size at which participants can read with their maximum reading speed.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660680|NCT01577381|Secondary|Change From Baseline in Critical Print Size Reading at 9, 12, 15 Months and End of Study|The critical print size is the smallest print size at which participants can read with their maximum reading speed.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660681|NCT01577381|Secondary|Percentage Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study|Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660682|NCT01577381|Secondary|Change From Placebo in Reading Acuity at 9, 12, 15 Months and End of Study|Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660683|NCT01577381|Secondary|Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study|Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD (logrithmic Reading Acuity Determination).|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660684|NCT01577381|Secondary|Percentage Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study|Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660685|NCT01577381|Secondary|Change From Placebo in Reading Speed at 9, 12, 15 Months and End of Study|Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660686|NCT01577381|Secondary|Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study|Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660687|NCT01577381|Secondary|Percentage Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study|Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Subjects were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660688|NCT01577381|Secondary|Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study|Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Participants were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660689|NCT01577381|Secondary|Percentage Change From Baseline in LL-BCVA Correct Number of Lines at 9, 12, 15 Months and End of Study|LL-BCVA is the measure of visual acuity under low light conditions.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660690|NCT01577381|Secondary|Percentage Change From Baseline in LL-BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study|LL-BCVA is the measure of visual acuity under low light conditions.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660691|NCT01577381|Secondary|Mean Low Luminance Best Corrected Visual Acuity (LL-BCVA) at 9, 12, 15 Months and End of Study|LL-BCVA is the measure of visual acuity under low light conditions.|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660692|NCT01577381|Secondary|Percentage Change From Baseline in BCVA Correct Number of Lines at Months 9, 12, 15 Months and End of Study|BCVA is measured using an eye chart and is reported as the number of lines read correctly in the study eye. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity).|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660693|NCT01577381|Secondary|Percentage Change From Baseline in BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660694|NCT01577381|Secondary|Mean Best Corrected Visual Acuity (BCVA) at 9, 12, 15 Months and End of Study|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).|Baseline, Month 9, Month 12, Month 15, and End of Study|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660696|NCT01577381|Primary|Mean Reduction (in Study Eye) in Rate of Growth of Geographic Atrophy (GA) at Day 309|GA is the advanced form of dry age-related macular degeneration (AMD). The reduction in GA area of the study eye was based on Fundus Autofluorescence (FAF) at 30 days post last dose administration (Day 309).|Baseline and Day 309|Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo).||||||
2660697|NCT01577329|Primary|Changes in Respiratory Rate|Breathing patterns will be measured at baseline using inductive plethysmography at baseline and at week eight. During that eight week time period the treatment group will have been exposed to a once a week mindfulness meditation class and the control group will have been exposed to health care as usual.|baseline and at week eight||||Breaths per minute||Standard Deviation|Mean
2660698|NCT01577238|Secondary|Adverse Events Potentially Related to Treatment|Number of participants with adverse events considered potentially related to study treatment|Screening/baseline through TOC visit, Day 1-30|Safety population. One participant of those randomized to the 1% SPL7013 Gel was lost to follow-up, and two participants of those randomized to Placebo did not use study medication, and therefore were not included in the Safety population.|||Participants|||Count of Participants
2660699|NCT01577238|Secondary|Number of Women With Nugent Cure at the TOC Visit|Nugent Cure is defined as a Nugent score of 0-3 (normal)|Day 21-30|mITT|||Participants|||Count of Participants
2660700|NCT01577238|Secondary|Number of Women With Clinical Cure at the Test of Cure Visit (TOC)|Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)|Day 21-30|mITT|||Participants|||Count of Participants
2660701|NCT01577238|Secondary|Number of Women With Nugent Cure at the EOT Visit|Nugent Cure is defined as a Nugent score of 0-3 (normal)|Day 9-12|mITT|||Participants|||Count of Participants
2660702|NCT01577238|Primary|Number of Women With Clinical Cure at the End of Treatment Visit (EOT)|Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)|Day 9-12|mITT|||Participants|||Count of Participants
2660703|NCT01577186|Other Pre-specified|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
2660704|NCT01577186|Other Pre-specified|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
2660705|NCT01577186|Primary|Percentage of Participants Achieving Improvement in Personal and Social Performance (PSP) Score by at Least One Category on PSP Scale|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.|End of study (Up to Week 12)|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment.|||percentage of participants||95% Confidence Interval|Number
2660706|NCT01577186|Secondary|Social Functioning Scale (SFS) Score|The SFS is a 36-item scale designed to assess social functioning in schizophrenia. It assesses abilities and performance in seven areas: social engagement, interpersonal communication, activities of daily living, recreation, social activities, competence at independent living, and occupation/employment. Total score ranges from 1 to 100 where higher score indicates a more favorable health state.|End of study (Up to Week 12)|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2660707|NCT01577186|Primary|Percentage of Participants Achieving Symptomatic Remission by Means of Positive and Negative Syndrome Scale (PANSS)|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity.|End of study (Up to Week 12)|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment.|||percentage of participants||95% Confidence Interval|Number
2660708|NCT01577160|Secondary|Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12|The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response (SR). A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive SR; a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
2660709|NCT01577160|Secondary|Change From Baseline in Personal and Social Performance (PSP) Score at Week 12|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
2660710|NCT01577160|Secondary|Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score|The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants evaluable for this measure.|||participants|||Number
2660711|NCT01577160|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|Baseline, Week 12|ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point.|||units on a scale||Standard Deviation|Mean
2660712|NCT01577160|Primary|Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale|"The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Responders were defined as participants evaluated as 1: very much improved or 2: much improved on the CGI-I scale at Week 12."|Week 12|Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants evaluable for this measure.|||percentage of participants||95% Confidence Interval|Number
2660713|NCT01577108|Primary|Number of GBS-Positive Pregnant Women Who Became GBS-Negative at Childbirth|To exam the GBS colonization in both vagina and rectum when childbirth. The purpose of this study is to examine whether oral taking Lactobacillus-containing probiotics can reduce the GBS colonization rate of vagina and rectum in pregnant women who present with GBS-positive.|2 weeks after taking probiotic|The GBS colonization results changed from positive to negative in 21 women in the probiotic group (42.9%) and in nine women in the placebo group (18.0%) during this period.|||Participants|||Count of Participants
2660714|NCT01576952|Primary|Ocular Inflammation|"Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells, and no rescue medications."|15 days|Modified Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method.|||participants|||Number
2660715|NCT01576939|Secondary|How Does Increase in Pain Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose?|"The quality of life questionnaire was the HNC adaptation of the Oral Mucositis Daily Questionnaire (OMDQ). It is designed to assess the severity and impact of the oral mucositis by evaluating mouth and throat soreness and the degree to which the mouth and throat soreness interferes with activities of daily life such as eating, swallowing, drinking, talking and sleeping.~This outcome measures pain in the mouth only.~This outcome is not a combination of several sub-scales. This outcome was the response to a single question: On a scale from 0 to 10, what number best describes the MOUTH PAIN that you experienced in the past 24 hours?~Mouth pain scale was measured as a single scale from 0 (no pain) to 10 (worst pain imaginable)."|3 years|Only 29 out of the 30 subjects filled out the pain surveys|||units on pain scale||95% Confidence Interval|Mean
2660716|NCT01576939|Secondary|How Does Increase in Soreness Scores Affect Quality of Life Questionnaire While Adjusting for the Measured Lateral Tongue Mucosal Dose|"The quality of life questionnaire was the HNC adaptation of the Oral Mucositis Daily Questionnaire (OMWQ). It is designed to assess the severity and impact of the oral mucositis by evaluating mouth and throat soreness and the degree to which the mouth and throat soreness interferes with activities of daily life such as eating, swallowing, drinking, talking and sleeping.~This outcome measures soreness in both the mouth and throat.~This outcome is not a combination of several sub-scales. This outcome was the response to the single question: On a scale from 0 to 10, how would you rate your OVERALL MOUTH AND THROAT SORENESS during the past 24 hours?~Mouth and throat soreness was measured as a single scale from 0 (no soreness) to 10 (worst soreness possible)."|3 years||||units on soreness scale||95% Confidence Interval|Mean
2661041|NCT01574157|Secondary|Change in Urinary Albumin Levels|Urinary albumin is a marker of kidney damage|The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.||||percent change||95% Confidence Interval|Geometric Mean
2660717|NCT01576939|Secondary|Relationship Between the Measured Lateral Tongue Mucosal Dose and the Amount of Narcotic Use|The narcotics use was a patient reported measurement that was documented in the medical note in the patient chart. Patient self reported measurements are generally known to be unreliable.|3 years||||mg||95% Confidence Interval|Mean
2660718|NCT01576939|Primary|Duration of Grade 2 or Higher Oral Mucositis After First Oral Mucositis Was Observed.|"The duration of grade 2 or higher oral mucositis was measured as the time from the first time oral mucositis was observed by a clinician at the weekly checkup until the oral mucositis was resolved.~The data was analyzed in a mixed effects model to account for the within subject correlation, since each patient contributed two measurements to the data set. The model was limited to those subjects who had experienced mucositis and then the outcome was the duration of grade 2 or higher mucositis. This allowed us to model the data in a mixed effects model with the continuous outcome of duration of grade 2 or higher mucositis."|3 years|For each subject, both left and right sides were included as two measurements from the same individual.|||Days||95% Confidence Interval|Mean
2660719|NCT01576939|Primary|Time Until the Maximum Oral Mucositis Measured From the Start of Radiation Treatment.|"The time to onset of oral mucositis was measured from the start of radiation treatment until oral mucositis was visual observed by a clinician during the weekly checkup for the first time. Analysis done by Kaplan-Meier.~Adverse events were graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version (V) 4.0. Medical doctor performed evaluation and grading of clinical and functional mucositis for the measured site weekly during the radiation treatment course and biweekly after completion of radiation until oral mucositis was < grade 2. A pain medication assessment was done for each mucositis time point. Patients completed the Oral Mucositis Weekly Questionnaire-Head and Neck cancer (OMWQ-HN) during and after treatment until oral mucositis is < grade 2."|3 years|The entire cohort was analyzed|||Days||95% Confidence Interval|Median
2660720|NCT01576874|Secondary|Cortisol Response to Trier Social Stress Task|Cortisol measured immediately following the Trier Social Stress Task, to evaluate physiological stress response.|Immediately following the Trier Social Stress Task||||micrograms per deciliter||Standard Deviation|Mean
2660721|NCT01576874|Secondary|Stress Response to Trier Social Stress Task|"The TSST is the gold standard for evoking stress response in the laboratory. The participant must deliver a speech as though speaking to a group of hiring managers. The participant has 5 min to prepare, then three individuals unfamiliar to the participant (the audience) enter the room and are seated; the participant is instructed give the speech (without notes). The speech is delivered for 5 min, then the participant is instructed to serially subtract 13 from 1,022 as quickly and accurately as possible. The mental math recitation continues for 5 min, and at its conclusion, the spokesperson instructs the participant to stop and be seated, and the audience leaves the room. The total time for the TSST is 15 min.~The single stress item is derived from the CREMA Mood/Stress Assessment (Warthen & Tiffany, 2009), asking how stressed the participant felt at that time, on a 5-point Likert scale, ranging 1-5 with higher score indicating feeling more stressed"|Immediately after the conclusion of the TSST||||units on a scale||Standard Deviation|Mean
2660722|NCT01576874|Primary|Craving Response to Trier Social Stress Task|"The TSST is the gold standard for evoking stress response in the laboratory. The participant must deliver a speech as though speaking to a group of hiring managers. The participant has 5 min to prepare, then three individuals unfamiliar to the participant (the audience) enter the room and are seated; the participant is instructed give the speech (without notes). The speech is delivered for 5 min, then the participant is instructed to serially subtract 13 from 1,022 as quickly and accurately as possible. The mental math recitation continues for 5 min, and at its conclusion, the spokesperson instructs the participant to stop and be seated, and the audience leaves the room. The total time for the TSST is 15 min.~The Craving Questionnaire (Carter & Tiffany, 2001) is the sum of 4 items, each rated 1-5 on a Likert scale, with total score ranging 4-20, and higher scores indicating higher craving."|Immediately after the conclusion of the TSST||||units on a scale||Standard Deviation|Mean
2660723|NCT01576809|Secondary|Safety and Tolerability of the Syrup|Number of participants with adverse events.|1 hour||||participants|||Number
2660724|NCT01576809|Secondary|Subject Acceptability of the Syrup|"In response to the question How did you like the warming sensation you have experienced for this product?, the number of patients answering Like extremely or Like very much or Like moderately or Like slightly~Possible responses are :~Like extremely Like very much Like moderately Like slightly Neither like nor dislike Dislike slightly Dislike moderately Dislike very much Dislike extremely"|1 hour||||participants|||Number
2660725|NCT01576809|Primary|Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Phenylephrine 10mg + Guaifenesin 200 mg Per 30 ml Syrup|Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0= no warming sensation and 100= strongest possible warming sensation|1 minutes||||mm||Standard Deviation|Mean
2660726|NCT01576783|Other Pre-specified|Other Long-term Outcomes: Behavior|Long-term (26-32 months of age) outcomes. This will be evaluated using reports/diagnoses of behavioral difficulties.|Long-term effect (6 months +) after intervention completion|||||||
2660727|NCT01576783|Other Pre-specified|Other Long-term Outcomes: Developmental Delay|Long-term (26-32 months of age) outcomes. This will be evaluated using reports/diagnoses of developmental delay.|Long-term effect (6 months +) after intervention completion|||||||
2660728|NCT01576783|Other Pre-specified|Other Long-term Outcomes: Language|Long-term (26-32 months of age) outcomes. This will be evaluated using scores on the Communicative Development Inventory (CDI).|Long-term effect (6 months +) after intervention completion|||||||
2660729|NCT01576783|Other Pre-specified|Other Long-term Outcomes: Pervasive Developmental Problems|Long-term (26-32 months of age) outcomes. This will be evaluated using scores on the Pervasive Developmental Problems DSM oriented scale on the Child Behavior Checklist 1.5-5 (CBCL).|Long-term effect (6 months +) after intervention completion|||||||
2660730|NCT01576783|Other Pre-specified|Long-term Efficacy in Improving Executive Functions|Long-term (26-32 months of age) executive function outcomes. This will be evaluated using scores on the ADHD DSM oriented subscale and the Attention syndrome subscale of the Child Behavior Checklist 1.5-5 (CBCL).|Long-term effect (6 months +) after intervention completion||2020-12-31|12/2020||||
2660731|NCT01576783|Other Pre-specified|Long-term Efficacy in Improving Executive Functions|Long-term (26-32 months of age) executive function outcomes. This will be evaluated using scores on the Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P).|Long-term effect (6 months +) after intervention completion|||||||
2660734|NCT01576783|Other Pre-specified|Other Long-term Outcomes: Sleep|Long-term (26-32 months of age) outcomes. This will be evaluated using scores on the Brief Infant Sleep Questionnaire (BISQ).The following sleep characteristics were captured based on caregiver-report: nocturnal sleep duration (hours), daytime sleep duration (hours), total sleep duration within a 24-hour period (hours). Larger values represent more time spent in each type of sleep. BISQ scores were measured at baseline and then again at post-intervention follow-up (approximately 8 months after the trial ended). The scores were calculated as a change between two time points (the BISQ value at post-intervention follow-up minus the BISQ value at baseline).|Long-term effect (6 months +) after intervention completion||||hours||Standard Deviation|Mean
2660735|NCT01576783|Other Pre-specified|Pervasive Developmental Disorders Screening Test - II, Stage 2 (PDDST-II)|The PDDST-II is a clinically derived, caregiver-completed screener to assist in differentiating an ASD diagnosis from other disorders in children with developmental concerns, including those born preterm. The PDDST-II comprised 14 yes/no items that indicate the presence (1) or absence (0) of developmental concerns. Items were summed (possible range: 0-14) and higher scores represented greater developmental concern, with a cut-score >5 signifying concern for ASD.|180 days post-randomization||2020-12-31|12/2020||||
2660736|NCT01576783|Other Pre-specified|Brief Infant Toddler Social Emotional Assessment (BITSEA)|BITSEA measures socioemotional development in toddlerhood. Scores were summed to provide competence (range: 0-22) and problem (range: 0-62) scores, respectively. The problem scale is further divided into subscales: externalizing (6 items; range: 0-12), internalizing (8 items; range: 0-16), and dysregulation (8 items; range: 0-16). Additionally, 14 items comprise a red flag scale (range: 0-28). Eight items from the competence and nine items from the problem subscales are indicative of behaviors often seen in children with ASD. Each of the 17 ASD items was dichotomized to illustrate the presence (1) (i.e., competence items absent, problem items present) or absence (0) (i.e., competence items present, problem items absent) of each ASD behavior. Items were then summed to derive an ASD score (range: 0-17). Higher competence scores represent better functioning, whereas higher problem (including the problem subscales), red flag, and ASD scores were indicative of poorer functioning.|180 days post-randomization||2020-12-31|12/2020||||
2660737|NCT01576783|Other Pre-specified|Body Composition|Changes in body composition from baseline to 6 months post-randomization (weight, recumbent length, head circumference, mid-upper arm circumference, triceps and subscapular skinfolds).|Baseline to 180 days post-randomization|||||||
2660738|NCT01576783|Other Pre-specified|Brief Infant Sleep Questionnaire (BISQ)|The following sleep characteristics were captured based on caregiver-report: nocturnal sleep duration (hours), daytime sleep duration (hours), total sleep duration within a 24-hour period (hours). Larger values represent more time spent in each type of sleep. BISQ scores were measured at baseline and then again at study completion (180 days post randomization). The scores were calculated as a change between two time points (the BISQ value at 180 days minus the BISQ value at baseline).|Baseline to 180 days post-randomization||||hours||Standard Deviation|Mean
2660739|NCT01576783|Secondary|(Development) Bayley Scales of Infant and Toddler Development, Third Edition(Bayley-III)|Bayley Scales of Infant and Toddler Development, third edition, (Bayley-III) is an instrument designed to measure the developmental functioning of infants and toddlers between the ages of 1 month and 42 months (age adjustments for prematurity are accommodated with the tool). It provides age specific composite scores for cognitive (91 items,score min 55 max 145), language (98 items, score min 47 max 153), and motor (138 items, score min 46 max 154) skills. For all scales, higher scores are better and lower scores indicate possible delay/deficit. Bayley-III scores were measured at baseline and then again at study completion (180 days post randomization). The scores were calculated as a change between two time points (the Bayley-III value at 180 days minus the Bayley-III value at baseline). Secondary Outcome for 1st stage of project funded by Allen Foundation, Inc; Primary Outcome for 2nd stage of project funded by March of Dimes and Health Resources and Services Administration|Baseline to 180 days post-randomization||||units on a scale||Standard Deviation|Mean
2660740|NCT01576783|Secondary|(Behavior) Infant Behavior Questionnaire-Revised (IBQ-R; Short Form)|Infant Behavior Questionnaire-Revised (IBQ-R; short form) was used to assess effortful control (12 items) and activity level (3 items). The IBQ-R measures early temperament-based inhibitory control,a key component of executive function as children mature. Scores range from 1 to 7, with higher scores indicating greater frequency of behaviors. IBQ-R scores were measured at baseline and then again at study completion (180 days post randomization). The scores were calculated as a change between two time points (the IBQ-R value at 180 days minus the IBQ-R value at baseline).|Baseline to 180 days post-randomization||||units on a scale||Standard Deviation|Mean
2660741|NCT01576783|Primary|Adherence|The mean (average) percentage of packets consumed by the children assigned to the supplement or placebo. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc|Baseline to 180 days post-randomization||||average percentage of packets consumed||Standard Deviation|Mean
2660742|NCT01576783|Primary|Enrollment and Trial Completion|The number of children who enroll in the trial and the number of those children who return for study visits 2 and 3. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc.|Baseline to 180 days post-randomization||||Participants|||Count of Participants
2660743|NCT01576783|Primary|Erythrocyte Fatty Acid Levels (Additional Data)|This outcome measure involved an examination of change in plasma and RBC fatty acid concentrations from the first study visit to the final study visit. The changes were calculated as the fatty acid level at 180 days minus the fatty acid level at baseline. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc|Baseline to 180 days post-randomization|"Rows titles are fatty acids with different C:D ratio where, C= Carbohydrate; D = Double bond; C:D is the ratio of the total amount of Carbon atoms of the fatty acid in relation to the number of double (unsaturated) bonds in it. Funding allotted for 205 children to be randomized to provide blood specimens but only 173 gave pre and post samples"|||ratio||Standard Deviation|Mean
2660752|NCT01576718|Secondary|Maximum Observed Plasma Concentration (Cmax)||Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose|Pharmacokinetic analysis set. Two participants in the Fp MDPI 100 mcg treatment arm did not have AUC data. PK tests not run on participants in the Placebo MDPI arm.|||pg/mL||Standard Deviation|Mean
2661042|NCT01574157|Secondary|Change in Urinary Levels of Fibronectin|Fibronectin is a marker of kidney injury.|The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.||||percent change||95% Confidence Interval|Geometric Mean
2660744|NCT01576783|Primary|Erythrocyte Fatty Acid Levels|This outcome measure involved an examination of change in plasma and RBC fatty acid concentrations from the first study visit to the final study visit. The changes were calculated as the fatty acid level at 180 days minus the fatty acid level at baseline. Primary Outcome for 1st stage of project funded by Allen Foundation, Inc|Baseline to 180 days post-randomization|"Rows titles are fatty acids with different C:D ratio where, C= Carbohydrate; D = Double bond; C:D is the ratio of the total amount of Carbon atoms of the fatty acid in relation to the number of double (unsaturated) bonds in it. Funding allotted for 205 children to be randomized to provide blood specimens but only 173 gave pre and post samples"|||nmol/mL||Standard Deviation|Mean
2660745|NCT01576718|Other Pre-specified|Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period (Including the Flovent Diskus Treatment Arm)|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.~PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake.~The p-values for the treatment comparisons to Flovent Diskus are from an MMRM model that included data for all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns.|||liters/minute||Standard Error|Least Squares Mean
2660746|NCT01576718|Other Pre-specified|Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period (Including the Flovent Diskus Treatment Arm)|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.~On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit.~Baseline trough AM PEF was defined as the average of recorded (nonmissing) trough AM PEF assessments over the 7 days directly preceding first study drug intake.~The p-values for the treatment comparisons to Flovent Diskus are from an MMRM model that included data for all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns.|||liters/minute||Standard Error|Least Squares Mean
2660747|NCT01576718|Other Pre-specified|Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period (Including the Flovent Diskus Treatment Arm)|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.~On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit.~Baseline trough AM PEF was defined as the average of recorded (nonmissing) trough AM PEF assessments over the 7 days directly preceding first study drug intake.~The p-values for the treatment comparisons to Flovent Diskus are from an MMRM model which includes data from all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns.|||liters||Standard Error|Least Squares Mean
2660748|NCT01576718|Secondary|24-Hour Urinary Cortisol Excretion at Baseline, Week 12 and Endpoint|24-hour urinary cortisol excretion was determined from 24-hour pooled-urine samples; urine was refrigerated until return to the investigational site after each 24-hour collection period. Urine was collected within 7 days of Day 1 and within 7 days of Week 12. Urine cortisol sample collection was not required at endpoint visit for subjects who terminated early from the study.|Baseline (Day 1), Week 12, Endpoint|Urine cortisol analysis set|||nmol/day||Standard Deviation|Mean
2660749|NCT01576718|Secondary|Patients With Positive Swab Test Results for Oral Candidiasis|"Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at each visit. Any visual evidence of oral candidiasis during the oropharyngeal exam was evaluated by obtaining and analyzing a swab of the suspect area.~This outcomes indicates how many patients had positive swab test results. The total number of patients who had oropharyngeal exams at each timepoint are specified in the timepoint field. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Subjects with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol."|Screening (Days -21 to -14), Randomization (Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12|Safety analysis set|||participants|||Number
2660750|NCT01576718|Secondary|Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 12|Safety analysis set|||participants|||Number
2660751|NCT01576718|Secondary|Time Of Maximum Observed Plasma Concentration (Tmax)||Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose|Pharmacokinetic analysis set. Two participants in the Fp MDPI 100 mcg treatment arm did not have AUC data. PK tests not run on participants in the Placebo MDPI arm.|||hours||Standard Deviation|Mean
2660753|NCT01576718|Secondary|Area Under The Plasma Concentration-Time Curve From Time Zero To The Time Of The Last Measurable Concentration (AUC0-t)||Day 1 predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose|Pharmacokinetic analysis set. Two participants in the Fp MDPI 100 mcg treatment arm did not have AUC data. PK tests not run on participants in the Placebo MDPI arm.|||pg*hr/mL||Standard Deviation|Mean
2660754|NCT01576718|Secondary|Change From Baseline In The Percentage Of Rescue-Free 24-Hour Periods|"The change from baseline in the percentage of rescue-free 24-hour periods was analyzed with a marginal (also called population averaged) logistic model, with the response being the proportion of rescue-free 24-hour periods. The model included 2 time points of measurement for each subject: the baseline (the last 7 days before the treatment period) and the treatment period. The model contained covariates for sex, age, and treatment. Rescue-free days were as indicated in patient diaries.~Data values are estimated means."|Baseline (Day -6 to Day 1 predose), Treatment (Day 1 to Week 12)|Full analysis set including participants who contributed at least once to the analysis.|||percentage of total 24 hour periods||Standard Error|Mean
2660755|NCT01576718|Secondary|The Kaplan-Meier Estimate Of The Probability Of Remaining In The Study At Week 12|"The analysis of probability of remaining in the study at Week 12 used the time to patient withdrawal for worsening asthma. Worsening asthma was defined as:~clinic visit FEV1 below the FEV1 stability limit value calculated on Day 1.~any 7-day run-in or treatment window (using information from the patient diary) during which the subject experienced:~3 or more days in which the highest PEF has fallen below the PEF stability limit calculated on Day 1~3 or more days in which ≥12 inhalations/day of albuterol/salbutamol was used~2 or more days in which the subject experienced a nighttime asthma symptom score of >2~clinical asthma exacerbation, defined as worsening asthma requiring any treatment other than study drug or rescue albuterol/salbutamol including the use of systemic corticosteroids and/or ER visit or hospitalization.~Patients who had withdrawn due to reasons other than worsening asthma were right-censored at the date of last assessment."|Day 1 to Week 12|Full analysis set|||probability||95% Confidence Interval|Number
2660756|NCT01576718|Secondary|Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.~PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake.~The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints; evening PEF data for Flovent Diskus is reported in outcome #14.|||liters/minute||Standard Error|Least Squares Mean
2660757|NCT01576718|Secondary|Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.~On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit.~Baseline trough AM PEF was defined as the average of recorded (non-missing) trough AM PEF assessments over the 7 days directly preceding first study drug intake.~The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -6 to Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints; morning PEF data for Flovent Diskus is reported in outcome #13.|||liters/minute||Standard Error|Least Squares Mean
2660758|NCT01576718|Primary|Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period|"Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug, and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation.~The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Day 1 pre-dose), Weeks 1, 2, 3, 4, 6, 8, 10 and 12|Full analysis set, including participants who contributed at least once to the analysis. Based on blinded data review, data from one site are excluded due to good clinical practice (GCP) concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints; FEV1 data for Flovent Diskus is reported in outcome #12.|||liters||Standard Error|Least Squares Mean
2660759|NCT01576588|Secondary|Overall Survival|Overall survival (OS) will be defined as the interval from date of randomization until the date of death from any cause, assessed up to 100 months.|from date of randomization until the date of death from any cause, assessed up to 100 months||||months||Full Range|Median
2660760|NCT01576588|Secondary|Number of Participants With Adverse Events|Adverse events NCI CTCAE, version 4.0. Hematological toxicity was evaluated according to IWCLL 2008 guidelines.|6 months.|Patient, who experienced any AE - 23.|||Participants|||Count of Participants
2660761|NCT01576588|Secondary|Progression Free Survival|Progression free survival (PFS) will be defined as the interval from entry into the study to disease progression or death.|up to 12 months||||months||Full Range|Median
2660846|NCT01575873|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 24|Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).|Baseline and month 24|Randomized participants with a baseline and month 24 measurement for the lumbar spine BMD.|||percent change||95% Confidence Interval|Least Squares Mean
2660762|NCT01576588|Primary|Overall Response Rate|Overall response rate (ORR) is defined according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL 2008) guidelines, as the proportion of patients achieving complete response (CR), CR with minimal residual disease (MRD) negativity (complete molecular remission), nodular partial remission (nPR) and partial response (PR).|3 months +/- 2 weeks after the last treatment cycle.||||Participants|||Count of Participants
2660763|NCT01576575|Primary|Plasma Cmax of Buprenorphine||96 hr|0 participants analyzed. The PI has left the institution. Sincere efforts were made to contact the PI but were unsuccessful. No study data are available.||||||
2660764|NCT01576549|Secondary|Percent Change in Various Cell Types in the Blood From Baseline up to Week 24|Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.|Baseline up to Week 24|No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.||||||
2660765|NCT01576549|Primary|Percent Change in Synovial Immunoglobulin (Ig) Synthesis From Baseline up to Week 16|Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.|Baseline up to Week 16|No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.||||||
2660766|NCT01576549|Primary|Percent Change in Synovial B Cell Mass From Baseline up to Week 16|Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.|Baseline up to Week 16|No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.||||||
2660767|NCT01576549|Primary|Percent Change in Synovitis Scores From Baseline up to Week 16|Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.|Baseline up to Week 16|No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.||||||
2660768|NCT01576536|Secondary|Percentage, Collagen Induced Platelet Aggregation|Blood samples were taken from participants and centrifuged. Collagen at a fixed concentration of 2.5 ug/ml was added. Agonist-induced platelet aggregation was expressed as the percentage aggregation after 6 minutes of stimulation.|at 6am and 930am|Some outcome date could not be collected for all subjects, unable to draw enough blood at a particular time point.|||percentage of platelet aggregation||Standard Deviation|Mean
2660769|NCT01576536|Secondary|Percentage, Adenosine Diphosphate (ADP) Induced Platelet Aggregation|Blood samples were taken from participants and centrifuged. Adenosine Diphosphate (ADP) at a fixed concentration of 2.5 uM was added. Agonist-induced platelet aggregation was expressed as the percentage aggregation after 6 minutes of stimulation.|at 6am and 930am|some outcome data could not be collected for all subjects, unable to draw enough blood for a particular timepoint|||percentage of aggregation||Standard Deviation|Mean
2660770|NCT01576536|Primary|LogEC50 Platelet Aggregation|EC50 represents the epinephrine concentration that produced 50% of maximal platelet aggregation (representing sensitivity to epinephrine) EC50 values were not normally distributed and were log-transformed for analyses.|at 6am and 930am|outcome data could not be collected on all subjects, since unable to draw enough blood at a particular timepoint|||nM||Standard Deviation|Mean
2660771|NCT01576471|Primary|Evaluate the Effects of TSO on the Induction of Response in Crohn's Disease, as Measured Primarily by Crohn's Disease Activity Index (CDAI)|CDAI >= 100 point reduction from baseline|12 weeks|all patients randomized and treated with at least 1 dose of study medication|||Participants|||Count of Participants
2660772|NCT01576406|Other Pre-specified|Duration of Response (DR)|DR was defined as the time from date of first documentation of CR or PR to first documentation of objective tumor progression or death due to any cause, whichever occurred first. In case of target lesions CR was defined as the disappearance of all target lesions and in case nodal disease included in the sum of target lesions. The nodes decreased to normal size (<10 mm). In case of non-target lesions disappearance of all non-target lesions and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Objective tumor progression as per RECIST version 1.1 was defined as >=20% increase in sum of diameters of target lesions taking as a reference smallest sum of diameters recorded since treatment started, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. DR was estimated using Kaplan-Meier method.|Baseline, every 8 weeks until disease progression or unacceptable toxicity up to end of treatment (up to 728 days)|Response evaluable population. Here, ‘N’ signifies participants who were evaluable for this outcome measure. Data for normal hepatic function (200 mg), moderate (250 mg) and severe (250 mg) hepatic impairment arms was not estimable since no participants had achieved CR or PR in these reporting arms.|||week||95% Confidence Interval|Median
2660773|NCT01576406|Other Pre-specified|Objective Response Rate (ORR)|ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version 1.1. In case of target lesions CR was defined as the disappearance of all target lesions and in case nodal disease included in the sum of target lesions. The nodes decreased to normal size (<10 mm). In case of non-target lesions disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Confirmed responses were those who persisted on repeat imaging study at least 4 weeks after the initial documentation of response.|Baseline, every 8 weeks until disease progression or unacceptable toxicity up to end of treatment (up to 728 days)|Response-evaluable population was defined as all participants in the safety analysis population who had an adequate baseline tumor assessment.|||percentage of participants||95% Confidence Interval|Number
2660774|NCT01576406|Other Pre-specified|Number of Participants With Abnormal Fundoscopy Examination Findings|Fundoscopy examination included an examination of the vitreous body, retina macula, retina non-macula, optic nerve head, optic disc notching and fundus using the category of the examination status (normal, mild, moderate, or severe). In this outcome measure, number of participants with abnormal fundoscopy values identified by investigator were reported.|Baseline up to end of treatment (up to 728 days)|Safety analysis population included all enrolled participants who received at least 1 dose of Crizotinib on Cycle 1, Day 1.|||participants|||Number
2661043|NCT01574157|Secondary|Change in Urinary Levels of Neutrophil Gelatinase-associated Lipocalin (NGAL)|NGAL is a marker of kidney injury|The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.||||percent change||95% Confidence Interval|Geometric Mean
2660775|NCT01576406|Other Pre-specified|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Criteria for abnormal value of ECG parameters: maximum increase from baseline (IFB) in QT interval using Fridericia's correction (QTcF)/QT interval using Bazett's correction (QTcB) range from less than (<)30 millisecond (msec), 30 to <60, greater than or equal to (>=)60 msec; maximum post-dose QTcF/QTcB ranges from <450 msec, 450 to <480 msec, 480 to <500, and >=500 msec; PR interval: >=50 percent (%) increase when baseline <200 msec; or increase >=25% when baseline less than or equal to (<=)200 msec; QRS interval: >=50% increase when baseline <100 msec; >=25% increase when baseline >=100 msec. Only categories which included atleast 1 participant with abnormality are reported in this outcome measure.|Baseline up to end of treatment (up to 728 days)|Safety analysis population included all enrolled participants who received at least 1 dose of Crizotinib on Cycle 1, Day 1.|||participants|||Number
2660776|NCT01576406|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities: NCI CTCAE (Version 4.0) Grade 1 to 4 Chemistry Test Abnormalities|ALT/AST(grade[g]1:>ULN-3*ULN,g2:>3-5*ULN,g3:>5-20*ULN,g4:>20*ULN);AP(g1:>ULN-2.5*ULN,g2:>2.5-5*ULN,g3:>5-20*ULN,g4:>20*ULN);CR(g1:>ULN-1.5*ULN,g2:>1.5-3*ULN,g3:>3-6*ULN,g4:>6*ULN);hyperglycemia(g1:>ULN-160mg/dL,g2:>160-250mg/dL,g3:>250-500mg/dL,g4:>500mg/dL);bilirubin(total)(g1:>ULN-1.5*ULN,g2:>1.5-3*ULN,g3:>3-10*ULN,g4:>10*ULN);hypoglycemia(g1:<LLN-55mg/dL,g2:<55-40mg/dL,g3:<40-30mg/dL,g4:<30mg/dL);hyperkalemia(g1:>ULN-5.5mmol/L,g2:>5.5-6mmol/L,g3:>6-7mmol/L,g4:>7mmol/L);hypokalemia(g1:<LLN-3mmol/L,g2:<LLN-3mmol/L,g3:<3-2.5mmol/L,g4:<2.5mmol/L);hypermagnesemia(g1:>ULN-3mg/dL,g3:>3-8mg/dL,g4:>8mg/dL);hypocalcemia(g1:<LLN-8mg/dL,g2:<8-7mg/dL,g3:<7-6mg/dL,g4:<6mg/dL);hypomagnesemia(g1:<LLN-1.2mg/dL,g2:<1.2-0.9mg/dL,g3:<0.9-0.7mg/dL,g4:<0.7mg/dL);hyponatremia(g1:<LLN-130mmol/L,g3:<130-120mmol/L,g4:<120mmol/L);hypoalbuminemia(g1:<LLN-3g/dL,g2:<3-2g/dL,g3:<2g/dL,g4:lifethreatening);hypophosphatemia(g1:<LLN-2.5mg/dL,g2:<2.5-2mg/dL,g3:<2-1mg/dL,g4:<1mg/dL).Participant>=1abnormality given.|Baseline up to end of treatment (up to 728 days)|Safety analysis population included all enrolled participants who received at least 1 dose of Crizotinib on Cycle 1, Day 1.|||participants|||Number
2660777|NCT01576406|Other Pre-specified|Number of Participants With Laboratory Test Abnormalities: NCI CTCAE (Version 4.0) Grade 1 to 4 Hematological Test Abnormalities|Anemia(grade[g]1:Less than[<] Lower limit of normal[LLN] to 10gram per[/] deciliter[g/dL],g2:<10 to 8g/dL,g3:<8g/dL,g4:lifethreatening);platelet (g1:<LLN to 75*10^3/millimeter[mm]^3,g2:<75*10^3/mm^3 to 50*10^3/mm^3,g3:<50*10^3/mm^3 to 25*10^3/mm^3,g4:<25*10^3/mm^3);lymphopenia(g1:<LLN to 8*10^2/mm^3,g2:<8*10^2 to 5*10^2/mm^3,g3:<5*10^2 to 2*10^2/mm^3,g4:<2*10^2/mm^3);neutrophil (Absolute)(g1:<LLN to 15*10^2/mm^3,g2:<15*10^2 to 10*10^2/mm^3,g3:<10*10^2 to 5*10^2/mm^3,g4:<5*10^2/mm^3);white blood cell count(g1:<LLN to 3*10^3/mm^3,g2:<3*10^3 to 2*10^3/mm^3,g3:<2*10^3 to 1*10^3/mm^3,g4:<1*10^3/mm^3);hemoglobin(g1:increase in hemoglobin level>0 to 2 g/dL above ULN or above baseline if baseline is above ULN,g2:increase in hemoglobin level>2 to 4g/dL above ULN or above baseline if baseline is above ULN,g3:increase in hemoglobin level>4 g/dL above ULN or above baseline if baseline is above ULN). Only categories with atleast 1 participant with abnormality are reported in this outcome measure.|Baseline up to end of treatment (up to 728 days)|Safety analysis population included all enrolled participants who received at least 1 dose of Crizotinib on Cycle 1, Day 1.|||participants|||Number
2660778|NCT01576406|Other Pre-specified|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious and non-serious adverse events.|From initiation of treatment up to follow-up period (up to 4 years)|Safety analysis population included all enrolled participants who received at least 1 dose of Crizotinib on Cycle 1, Day 1.|||participants|||Number
2660779|NCT01576406|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events, by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events [CTCAE] Version 4.0. Grade 1 =mild; Grade 2 =moderate; Grade 3 =severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4 =life-threatening or disabling, urgent intervention indicated; Grade 5 =death. Treatment-emergent events were events between first dose of study drug and up to 4 years that were absent before treatment that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 adverse event, only the maximum CTCAE was reported.|From initiation of treatment up to follow-up period (up to 4 years)|Safety analysis population included all enrolled participants who received at least 1 dose of Crizotinib on Cycle 1, Day 1.|||participants|||Number
2660780|NCT01576406|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 4 years that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|From initiation of treatment up to follow-up period (up to 4 years)|Safety analysis population included all enrolled participants who received at least 1 dose of Crizotinib on Cycle 1, Day 1.|||participants|||Number
2660781|NCT01576406|Other Pre-specified|Unbound Area Under the Plasma Concentration Time Curve as Daily Exposure (AUCdaily) of PF-06260182: Cycle 2 Day 1|Unbound AUCdaily of PF-06260182, (a metabolite of Crizotinib) is reported in this outcome measure, where AUCdaily was area under the plasma concentration time curve as daily exposure post-dose.|Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2660782|NCT01576406|Other Pre-specified|Area Under the Plasma Concentration Time Curve as Daily Exposure (AUCdaily) of PF-06260182: Cycle 2 Day 1|AUCdaily of PF-06260182, (a metabolite of Crizotinib) is reported in this outcome measure.|Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2660783|NCT01576406|Other Pre-specified|Unbound Area Under the Plasma Concentration Time Curve as Daily Exposure (AUCdaily) of Crizotinib: Cycle 2 Day 1||Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2660784|NCT01576406|Other Pre-specified|Area Under the Plasma Concentration Time Curve as Daily Exposure (AUCdaily) of Crizotinib: Cycle 2 Day 1||Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2660785|NCT01576406|Secondary|Unbound Maximum Observed Plasma Concentration (Cmax) of PF-06260182: Cycle 2 Day 1|Unbound Cmax of PF-06260182, (a metabolite of Crizotinib) is reported in this outcome measure.|Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2660786|NCT01576406|Secondary|Unbound Area Under Plasma Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06260182: Cycle 2 Day 1|Unbound area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval (tau hours post-dose, where tau was 12 hours for twice daily dosing and 24 hours for once daily dosing) of Cycle 2 Day 1. Unbound AUCtau of PF-06260182, (a metabolite of Crizotinib) is reported in this outcome measure.|Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2660787|NCT01576406|Secondary|Unbound Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Plasma Concentration (AUClast) of PF-06260182: Cycle 2 Day 1|Unbound AUClast of PF-06260182 (a metabolite of Crizotinib) is reported in this outcome measure.|Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|Data for this outcome measure was not estimated, since few secondary PK parameters listed in the protocol and/or SAP were not estimated, due to change in planned analysis. However, it did not affect the interpretation of the final PK data.||||||
2660788|NCT01576406|Secondary|Fraction of Unbound PF-06260182 in Plasma: Cycle 2 Day 1|Fraction of unbound PF-06260182 (a metabolite of Crizotinib) in plasma was defined as the ratio of unbound PF-06260182 concentration in plasma to the total PF-06260182 concentration.|Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2660789|NCT01576406|Secondary|Metabolite Ratio for Maximum Observed Plasma Concentration (Cmax) of PF-06260182: Cycle 2 Day 1|Metabolite ratio for Cmax was defined as the ratio of Cmax of metabolite (PF-06260182) to Cmax of parent drug (Crizotinib), where Cmax was maximum observed plasma concentration post-dose of Cycle 2 Day 1.|Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2660790|NCT01576406|Secondary|Metabolite Ratio for Maximum Observed Plasma Concentration (Cmax) of PF-06260182: Cycle 1 Day 1|Metabolite ratio for Cmax was defined as the ratio of Cmax of metabolite (PF-06260182) to Cmax of parent drug (Crizotinib), where Cmax was maximum observed plasma concentration post-dose of Cycle 1 Day 1.|Cycle 1 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set. Here, ‘N’ signifies those participants who were evaluable for this measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2660847|NCT01575873|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12|Bone mineral density at the total hip was measured by dual-energy x-ray absorptiometry (DXA).|Baseline and month 12|Randomized participants with a baseline and month 12 measurement for the total hip BMD.|||percent change||95% Confidence Interval|Least Squares Mean
2661044|NCT01574157|Secondary|Change in Urinary Levels of Kidney Injury Molecule-1 (KIM-1)|KIM-1 is a marker of of kidney injury.|The mean of the 3-month and 6-month measurements will be compared to the baseline values between the groups.||||percent change||95% Confidence Interval|Mean
2660791|NCT01576406|Secondary|Metabolite Ratio for Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUClast) of PF-06260182: Cycle 1 Day 1|Metabolite ratio for AUClast was defined as the ratio of AUClast of metabolite (PF-06260182) to AUClast of parent drug (Crizotinib), where AUClast was area under the plasma concentration-time curve from time zero to the last quantifiable plasma concentration post-dose of Cycle 1 Day 1.|Cycle 1 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set. Here, ‘N’ signifies those participants who were evaluable for this measure.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2660792|NCT01576406|Secondary|Metabolite Ratio for Area Under Plasma Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06260182: Cycle 2 Day 1|Metabolite ratio for AUCtau was defined as the ratio of AUCtau of metabolite (PF-06260182) to AUCtau of parent drug (Crizotinib), where AUCtau was the area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval (tau was 12 hours for twice daily dosing and 24 hours for once daily dosing) of Cycle 2 Day 1.|Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2660793|NCT01576406|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06260182: Cycle 2 Day 1|Tmax of PF-06260182, (a metabolite of Crizotinib) is reported in this outcome measure.|Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.|||hour||Full Range|Median
2660794|NCT01576406|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06260182: Cycle 1 Day 1|Tmax of PF-06260182, (a metabolite of Crizotinib) is reported in this outcome measure.|Cycle 1 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set. Here, ‘N’ signifies those participants who were evaluable for this measure.|||hour||Full Range|Median
2660795|NCT01576406|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-06260182: Cycle 2 Day 1|Cmax of PF-06260182, (a metabolite of Crizotinib) is reported in this outcome measure.|Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2660796|NCT01576406|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-06260182: Cycle 1 Day 1|Cmax of PF-06260182, (a metabolite of Crizotinib) is reported in this outcome measure.|Cycle 1 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set. Here, ‘N’ signifies those participants who were evaluable for this measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2660797|NCT01576406|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Plasma Concentration (AUClast) of PF-06260182: Cycle 1 Day 1|AUClast of PF-06260182, (a metabolite of Crizotinib) is reported in this outcome measure.|Cycle 1 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set. Here, ‘N’ signifies those participants who were evaluable for this measure.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2660798|NCT01576406|Secondary|Area Under Plasma Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06260182: Cycle 2 Day 1|Area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval (tau hours postdose, where tau was 12 hours for twice daily dosing and 24 hours for once daily dosing) of Cycle 2 Day 1. AUCtau of PF-06260182, (a metabolite of Crizotinib) is reported in this outcome measure.|Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2660799|NCT01576406|Secondary|Unbound Maximum Observed Plasma Concentration (Cmax) of Crizotinib: Cycle 2 Day 1||Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2660800|NCT01576406|Secondary|Unbound Area Under Plasma Concentration-Time Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib: Cycle 2 Day 1|Unbound area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval (tau hours post-dose, where tau was 12 hours for twice daily dosing and 24 hours for once daily dosing) of Cycle 2 Day 1.|Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2660801|NCT01576406|Secondary|Unbound Area Under the Plasma Concentration Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUClast) of Crizotinib: Cycle 2 Day 1|Unbound area under the plasma concentration-time curve from time zero to the last quantifiable plasma concentration post-dose of Cycle 2 day 1.|Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|Data for this outcome measure was not estimated, since few secondary PK parameters listed in the protocol and/or SAP were not estimated, due to change in planned analysis. However, it did not affect the interpretation of the final PK data.||||||
2660802|NCT01576406|Secondary|Fraction of Unbound Crizotinib in Plasma: Cycle 2 Day 1|Fraction of unbound Crizotinib concentration in plasma was defined as the ratio of unbound Crizotinib concentration to the total Crizotinib concentration.|Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2660803|NCT01576406|Secondary|Apparent Oral Clearance (CL/F) of Crizotinib: Cycle 2 Day 1|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent oral clearance was obtained by dividing study drug dose with AUCtau, where AUCtau was area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval (tau hours post-dose, where tau was 12 hours for twice daily dosing and 24 hours for once daily dosing) of Cycle 2 Day 1.|Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.|||Liter/hour||Geometric Coefficient of Variation|Geometric Mean
2660804|NCT01576406|Secondary|Plasma Accumulation Ratio (Rac) of Crizotinib|Rac was defined as the ratio of AUCtau of Cycle 2 Day 1 to AUCtau of Cycle 1 Day 1, where AUCtau was area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval (tau hours post-dose, where tau was 12 hours for twice daily dosing and 24 hours for once daily dosing).|Cycle 1 Day 1 and Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|Data for this outcome measure was not estimated, since few secondary PK parameters listed in the protocol and/or SAP were not estimated, due to change in planned analysis. However, it did not affect the interpretation of the final PK data.||||||
2660805|NCT01576406|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUClast) of Crizotinib: Cycle 2 Day 1||Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|Data for this outcome measure was not estimated, since few secondary PK parameters listed in the protocol and/or SAP were not estimated, due to change in planned analysis. However, it did not affect the interpretation of the final PK data.||||||
2660806|NCT01576406|Secondary|Minimum Observed Plasma Concentration (Cmin) of Crizotinib: Cycle 2 Day 1||Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2660807|NCT01576406|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Crizotinib: Cycle 1 Day 1||Cycle 1 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set. Here, ‘N’ signifies those participants who were evaluable for this measure.|||hour||Full Range|Median
2660808|NCT01576406|Secondary|Maximum Observed Plasma Concentration (Cmax) of Crizotinib: Cycle 1 Day 1||Cycle 1 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set. Here, ‘N’ signifies those participants who were evaluable for this measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2660809|NCT01576406|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUClast) of Crizotinib: Cycle 1 Day 1||Cycle 1 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2660810|NCT01576406|Primary|Maximum Observed Plasma Concentration (Cmax) of Crizotinib: Cycle 2 Day 1||Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set: C2D1 full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2660811|NCT01576406|Primary|Area Under Plasma Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib: Cycle 2 Day 1|Area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval (tau hours post-dose, where tau was 12 hours for twice daily dosing and 24 hours for once daily dosing) of Cycle 2 Day 1.|Cycle 2 Day 1- Twice daily dosing: pre-dose and 1, 2, 4, 6, 8, 12 hours post-dose; Once daily dosing: pre-dose and 1, 2, 4, 6, 8, 24 hours post-dose|PK evaluable set:Cycle 2 Day 1(C2D1)full PK collected;no dose change;atleast 14 days of constant dosing before C2D1 or>80% of Crizotinib during 14 days prior to C2D1;not vomited Crizotinib on same day of PK collection on C2D1;no prior major GI surgery;11 days of constant dosing instead of 14 days before C2D1 but met all other PK evaluable criteria.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2660812|NCT01576367|Secondary|Number of Vaccination Cases With Protective Antibody Levels Following Immunization With Inactivated Vaccines|Participants who received any inactivated vaccines during the study were assessed for their ability to attain protective antibody levels against the vaccine (antigen) post immunization. Participants vaccinations were not assessed for a response if the antibody titre was already sufficient at pre-dose and maintained during the study.|pre-vaccine dose, Day 28 post-vaccine|Extension Full analysis set (FAS) consisted of all patients who received at least one dose of study drug in the extension study. Out of 20 unique patient-vaccination cases, 17 cases were assessable for a vaccination response due to availability of pre dose antibody titer.|||vaccination cases|patient-vaccination cases||Number
2660813|NCT01576367|Secondary|Frequency Counts of Physician's Global Assessment of Autoinflammatory Disease and Skin Disease|Participants were assessed based by physician on Physician's Global Assessment measured on a 5--point scale for auto inflammatory disease activity as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe|minimum of 6 months and maximum of 24 months|Extension Full analysis set (FAS) consisted of all patients who received at least one dose of study drug in the extension study|||Percentage of participants|||Number
2660814|NCT01576367|Secondary|Change From Baseline (Core Study Baseline) in C--Reactive Protein (CRP) and Serum Amyloid A (SAA) Concentrations|CRP and SAA were used as serologic inflammatory markers. The target level concentrations for CRP and SAA was ≤15 mg/L and ≤10 mg/L, respectively. Negative change in concentration of inflammatory markers indicated improvement.|Week 0, 80, 104, 128 and 152, last assessment|Extension Full analysis set (FAS) consisted of all patients who received at least one dose of study drug in the extension study|||(mg/L)||Standard Deviation|Mean
2660815|NCT01576367|Secondary|Immunogenicity of Canakinumab (ACZ885). Number of Participants With Anti-canakinumab Antibodies|Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system, with detection based on surface plasmon resonance technique.|minimum of 6 months and maximum of 24 months|Extension Safety set consisted of all patients from the core study who received at least one dose of study drug in the extension study and had at least one post-treatment safety assessment. Of note, the statement that a patient had no AE also constituted a safety assessment.|||Participants|||Number
2660816|NCT01576367|Primary|The Percentage of Participants Without Disease Relapse as Determined by the Physician's Global Assessment of Autoinflammatory Disease Activity, Assessment of Skin Disease and Serological Inflammation Markers.|Disease relapse following complete response is defined as inflammation markers: C-Reactive Protein (CRP) and/or Serum Amyloid A (SAA) result > 30 mg/L AND Physician's Global Assessment of Autoinflammatory Disease Activity > minimal or Physician's Global Assessment >= minimal AND Skin Disease Assessment > minimal. Physician's Global Assessment of Autoinflammatory Disease Activity and Skin Disease Assessment (urticarial skin rash) are completed by the investigator using a 5 point rating scale: absent, minimal, mild, moderate and severe.|Week /80, 104, 128, and 152 (A minimum of 6 months and maximum of 24 months)|Extension Full analysis set (FAS) consisted of all patients who received at least one dose of study drug in the extension study|||Percentage of participants|||Number
2660817|NCT01576341|Secondary|Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study)|Actual values of hemoglobin levels at end of study visit and change from Baseline Period (Week -4 to Week -1)|52 weeks|Per-protocol population (all patients that received at least one dose of study drug) with non-missing Hemoglobin value at Visit 16 (end of study).|||g/dL||Standard Deviation|Mean
2660818|NCT01576341|Primary|Anti-Erythropoietin (EPO) Antibodies|The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay|52 weeks|Safety population: The safety population consists of all patients that received at least one dose of study drug|||percentage of participants||95% Confidence Interval|Number
2660819|NCT01576276|Primary|Pain Ratings|The primary endpoint was the morphine and ketorolac conditioning effects as indicated by subjective pain rating changes between pain only (a control condition with no injection of glucose, but subject's did see an image of an hour glass displaying how much time they had before receiving a painful stimulus) and pain+glucose (subjects received a glucose injection accompanied by an injection schematic followed by a painful stimulus) within the morphine and ketorolac groups. We used the Gracely pain rating scale (ranging from 0, no sensation to 20, extremely painful).|One day||||units on a scale||Standard Deviation|Mean
2660820|NCT01576276|Primary|fMRI Signal Changes|Obtain information about brain activity, including BOLD (Blood-oxygen-level dependent) signal, using an fMRI system. Data analysis was applied using SPM 12 with a standard pipeline.|one day|Here we present the average fMRI (functional MRI) signal changes of clusters that survived a threshold of 0.005 with10 continuous voxels. We only reported beta values in pain related areas.|||Beta value||Standard Deviation|Mean
2660821|NCT01576159|Secondary|Physiological (Maximum Oxygen Consumption) Changes of Participants||Baseline and 12 weeks||||ml/kg/min||Standard Deviation|Mean
2660822|NCT01576159|Secondary|Physical (Body Mass Index) Changes of Participants||Baseline and 12 weeks||||kg/m^2||Standard Deviation|Mean
2660823|NCT01576159|Primary|Changes in Serum COMP Accumulation, Triggered by Acute Exercise, After 12 Weeks of Different Regular Exercises||Baseline and 12 weeks||||U/l||Standard Deviation|Mean
2660824|NCT01576146|Secondary|Percent Change From Baseline in Serum Phosphorus|"Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331).~The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13."|Baseline and Weeks 13, 26 and 52|The full analysis set (all participants who received at least 1 dose during the extension study) with data collected on or before the last non-missing dose of etelcalcetide (defined as on-treatment approach).|||percent change||Standard Error|Mean
2660825|NCT01576146|Secondary|Percent Change From Baseline in Serum Corrected Calcium|"Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331).~The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13."|Baseline and Weeks 13, 26 and 52|The full analysis set (all participants who received at least 1 dose during the extension study) with data collected on or before the last non-missing dose of etelcalcetide (defined as on-treatment approach).|||percent change||Standard Error|Mean
2660826|NCT01576146|Secondary|Percent Change From Baseline in Parathyroid Hormone|"Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of etelcalcetide in the parent study (20120331).~The week numbering for this study continued from the parent study 20120331 hence the first measurement for all parameters in the extension study started at week 13."|Baseline (of the parent study 20120331) and Weeks 13, 26 and 52|The full analysis set (all participants who received at least 1 dose during the extension study) with data collected on or before the last non-missing dose of etelcalcetide (defined as on-treatment approach).|||percent change||Standard Error|Mean
2660827|NCT01576146|Primary|Number of Participants With Adverse Events||From the first dose of study drug in the parent study (20120331) through 30 days after the last dose in the extension study; actual median duration of treatment was 439 days.|Participants who received at least one dose of etelcalcetide in the extension study|||participants|||Number
2660828|NCT01576120|Primary|• Evaluate the Effectiveness of the PillCam COLON 2 Bowel Prep Regimen in Crohn's Disease Patients|"effectiveness of the PillCam COLON 2 bowel prep regimen in Crohn's Disease patients will be evaluated by the folloiwng: • Bowel preparation cleansing level assessment~The duration of the procedure in this study is 1 day of colon preparation and~1 day of Capsule Endoscopy (CE) procedure. 5-9 days after the CE procedure a follow up call to the subjects will be conducted."|The end points and outcomes measures will be evaluated within 4 months from end of enrollment||||percentage of participants||95% Confidence Interval|Number
2660829|NCT01576055|Secondary|Number of Participants With Device Success|Successful delivery of stent to the intended site and successful stent deployment.|Immediately following initial device implant (usually within a few minutes to an hour).|Per Protocol Population|||participants|||Number
2660830|NCT01576055|Secondary|Number of Participants With Procedural Success|Successful device implantation with a residual stenosis <30% without acute (within 48 hours) serious adverse events.|Within 48 hours of initial device implant|Per Protocol Population|||participants|||Number
2660831|NCT01576055|Primary|Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months|Primary patency is defined by a Peak Systolic Velocity Ratio (PSVR) ≤2.5 without target lesion revascularization (TLR) at 12 months after implantation.|12 Months|Per Protocol Population (Participants Available for 12-Month Follow-Up)|||participants|||Number
2660832|NCT01576055|Primary|Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days|Defined as any adverse event (occurring within 30 days of the initial procedure) that causes death, target vessel revascularization (TVR), and amputation above the metatarsals in the treated leg (index limb amputation).|30 Days|Per Protocol Population (Participants Available for 30-Day Follow-Up)|||participants|||Number
2660833|NCT01576042|Secondary|Number of Participants Received Treatment Assigned|Records participants who received study randomized treatment during the study|6 months||||participants|||Number
2660834|NCT01576042|Secondary|Time to First Recurrent ICD Therapy for VT|Days from the date of the first study treatment to the date of first ICD recurrent therapy for VT.|Baseline, 6 months||||Days||Standard Deviation|Mean
2660835|NCT01576042|Secondary|Number of Participants Switched to Other Arm|Records participants who received study treatment as randomized and later switched to other treatment arm during the study|6 months||||participants|||Number
2660836|NCT01576042|Secondary|Number of Participants Remained on Randomized Treatment Assignment|Records participants who only received study treatment as randomized during the entire study|6 month||||participants|||Number
2660837|NCT01576042|Secondary|Cardiovascular Hospitalizations|Records participants hospitalized for VT during the study|Baseline, 6 months||||participants|||Number
2660838|NCT01576042|Secondary|Number of Participants Had at Least One of the Efficacy Outcome Measurement|Records participants who had at least one of the efficacy outcome measurement (including death, hospitalization due to VT)|6 Months||||participants|||Number
2660839|NCT01576042|Secondary|Number of Participants Completed Month 6 Follow-Up|Records participants who completed Month 6 Follow-Up Visit|6 Months||||participants|||Number
2660840|NCT01576042|Primary|Number of Participants Completed Month 3 Follow-Up|Records participants who completed Month 3 Follow-Up Visit|3 months||||participants|||Number
2660841|NCT01575912|Primary|Visual Analog Scale Evaluation for the Pre-fixed Pressure Test|"pain tests will be realized during the first week of hospitalization for the persons hospitalized for major depression, and during the period of hospitalization (after stabilization) for the persons presenting schizophrenia.~The controls are tested within one month of the study information. total range : 0 - 10. The intensity of pain increases with the value of VAS. 10 corresponds to an unbearable pain."|one month|analysis per arm group|||units on a scale||Standard Deviation|Mean
2660842|NCT01575899|Secondary|Eradication Rate of Participants Living in Rural Area.|Subgroup analysis on eradication rate (percentage of participants with a negative result of C13 or CLO test at least four weeks after treatment) according to resident area of participants, especially who are living in rural area.|4 weeks after complete use of drug for treatment|Subgroup analysis (intent-to-treat) on eradication rate of participants who are living in rural area of Taiwan.|||percentage of eradicated participants|||Number
2660843|NCT01575899|Other Pre-specified|Re-eradication Rate|Re-eradication successful rate (percentage of participants with a negative result of C13 or CLO test at least four weeks after the 2nd treatment) with 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.|4 weeks after complete use of drug for treatment|This intent-to treat analysis is without control group, including patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.|||percentage of successful re-eradication|||Number
2660844|NCT01575899|Primary|Eradication Rate (Participants Naive to Anti-H. Pylori Treatment)|A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment.|4 weeks after complete use of drug for treatment|Intent to treat analysis of eradication (negative result of follow up method) measured 4 weeks after complete the treatment, for participants never received anti-H. pylori treatment before.|||percentage of eradicated participants|||Number
2660845|NCT01575873|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density at Month 24|Bone mineral density at the total hip was measured by dual-energy x-ray absorptiometry (DXA).|Baseline and month 24|Randomized participants with a baseline and month 24 measurement for the total hip BMD.|||percent change||95% Confidence Interval|Least Squares Mean
2660848|NCT01575873|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Superiority Analysis)|Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).|Baseline and month 12|Randomized participants with a baseline and month 12 measurement for the lumbar spine BMD.|||percent change||95% Confidence Interval|Least Squares Mean
2660849|NCT01575873|Primary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Non-inferiority Analysis)|Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).|Baseline and month 12|Randomized participants with a baseline and month 12 measurement for the lumbar spine BMD.|||percent change||95% Confidence Interval|Least Squares Mean
2660850|NCT01575834|Secondary|Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 24|Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and Month 24|Primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
2660851|NCT01575834|Secondary|Percent Change From Baseline in Bone Mineral Density of the Femoral Neck at Month 12|Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and Month 12|Primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
2660852|NCT01575834|Secondary|Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 24|Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and Month 24|Primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
2660853|NCT01575834|Secondary|Percent Change From Baseline in Bone Mineral Density of the Total Hip at Month 12|Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and Month 12|Primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
2660854|NCT01575834|Secondary|Percent Change From Baseline In Bone Mineral Density at the Lumbar Spine at Month 24|Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and Month 24|Primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
2660855|NCT01575834|Secondary|Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 12|Bone mineral density (BMD) was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.|Baseline and Month 12|Primary efficacy analysis set for BMD includes all randomized participants who had a baseline and ≥ 1 post-baseline evaluation at or before the time point under consideration in the study period; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
2660856|NCT01575834|Secondary|Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 24|A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4. A participant had multiple new or worsening vertebral fractures when there were ≥ 2 vertebrae from T4 to L4 with ≥ 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit.|24 Months|Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 24 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. LOCF imputation was used.|||percentage of participants|||Number
2660857|NCT01575834|Secondary|Percentage of Participants With Multiple New or Worsening Vertebral Fractures Through Month 12|A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4. A participant had multiple new or worsening vertebral fractures when there were ≥ 2 vertebrae from T4 to L4 with ≥ 1 grade increase from the previous grade. The multiple new or worsening vertebral fractures need not have occurred at the same visit.|12 Months|Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 24 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. LOCF imputation was used.|||percentage of participants|||Number
2660858|NCT01575834|Secondary|Percentage of Participants With a Major Osteoporotic Fracture Through Month 24|Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded.|24 Months|Full analysis set|||percentage of participants|||Number
2660859|NCT01575834|Secondary|Percentage of Participants With a Major Osteoporotic Fracture Through Month 12|Major osteoporotic fractures included clinical vertebral fractures and fractures of the hip, forearm and humerus. Fractures associated with high trauma severity or pathologic fractures were excluded.|12 Months|Full analysis set|||percentage of participants|||Number
2660860|NCT01575834|Secondary|Percentage of Participants With a Hip Fracture Through Month 24|Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.|24 Months|Full analysis set|||percentage of participants|||Number
2660861|NCT01575834|Secondary|Percentage of Participants With a Hip Fracture Through Month 12|Hip fractures were defined as a subset of nonvertebral fractures including fractures of the femur neck, femur intertrochanter, and femur subtrochanter.|12 Months|Full analysis set|||percentage of participants|||Number
2660917|NCT01575808|Secondary|Percent of Participants Not Experiencing an Adverse Event|% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown|24 months|||||||
2660862|NCT01575834|Secondary|Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 24|A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4.|24 Months|Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 24 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. LOCF imputation was used.|||percentage of participants|||Number
2660863|NCT01575834|Secondary|Percentage of Participants With a New or Worsening Vertebral Fracture Through Month 12|A new or worsening vertebral fracture was identified when there was a ≥ 1 grade increase from the previous grade in any vertebra from T4 to L4.|12 Months|Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 24 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. LOCF imputation was used|||percentage of participants|||Number
2660864|NCT01575834|Secondary|Percentage of Participants With a Major Nonvertebral Fracture Through Month 24|A major nonvertebral fracture was a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip.|24 Months|Full analysis set|||percentage of participants|||Number
2660865|NCT01575834|Secondary|Percentage of Participants With a Major Nonvertebral Fracture Through Month 12|A major nonvertebral fracture was a subset of nonvertebral fractures including pelvis, distal femur (ie, femur excluding hip), proximal tibia (ie, tibia excluding ankle), ribs, proximal humerus (ie, humerus excluding elbow), forearm, and hip.|12 Months|Full analysis set|||percentage of participants|||Number
2660866|NCT01575834|Secondary|Percentage of Participants With a Clinical Fracture Through Month 24|Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.|24 Months|Full analysis set; LOCF imputation was used|||percentage of participants|||Number
2660867|NCT01575834|Secondary|Percentage of Participants With a Nonvertebral Fracture Through Month 24|A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date as recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.|24 Months|Full analysis set|||percentage of participants|||Number
2660868|NCT01575834|Secondary|Percentage of Participants With a Nonvertebral Fracture Through Month 12|A nonvertebral fracture was defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging confirming the fracture within 14 days of reported fracture image date recorded by the study site, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.|12 Months|Full analysis set|||percentage of participants|||Number
2660869|NCT01575834|Secondary|Percentage of Participants With a Clinical Fracture Through Month 12|Clinical fractures included clinical vertebral and nonvertebral fractures (excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges) that were associated with signs and/or symptoms indicative of a fracture. Clinical vertebral fractures were included regardless of trauma severity or pathologic fractures; nonvertebral fractures associated with high trauma severity or pathologic fractures were excluded.|12 Months|Full analysis set; Last observation carried forward imputation (LOCF) was used.|||percentage of participants|||Number
2660870|NCT01575834|Primary|Percentage of Participants With New Vertebral Fracture Through Month 24|"New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant semiquantitative scoring method.~The Genant semiquantitative scoring method was based on assessment of x-rays according to the following scale:~Grade 0 (Normal) = no fracture;~Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);~Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;~Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height."|24 months|Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 24 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. Last observation carried forward imputation was used.|||percentage of participants|||Number
2660871|NCT01575834|Primary|Percentage of Participants With New Vertebral Fracture Through Month 12|"New vertebral fractures occurred when there was ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4 using the Genant semiquantitative scoring method.~The Genant semiquantitative scoring method was based on assessment of x-rays according to the following scale:~Grade 0 (Normal) = no fracture;~Grade 1 (Mild) = mild fracture, 20 to 25% reduction in vertebral height (anterior, middle, or posterior);~Grade 2 (Moderate) = moderate fracture, 25 to 40% reduction in anterior, middle, and/or posterior height;~Grade 3 (Severe) = severe fracture, greater than 40% reduction in anterior, middle, and/or posterior height."|12 Months|Primary efficacy analysis set includes all participants who had a baseline and ≥ 1 postbaseline evaluation of vertebral fracture during the 12 months, including participants with missing baseline Genant scores whose first postbaseline spinal radiograph showed no fracture on the same vertebrae. Last observation carried forward imputation was used.|||percentage of participants|||Number
2660872|NCT01575808|Secondary|Rate of Avoidance of Blood Transfusion||Post-Procedure||||Participants|||Count of Participants
2660873|NCT01575808|Secondary|Walking Impairment Questionnaire-WIQ|WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.|24 months|||||||
2660874|NCT01575808|Secondary|Walking Impairment Questionnaire-WIQ|WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.|12 months||||units on a scale||Standard Deviation|Mean
2660875|NCT01575808|Secondary|Walking Impairment Questionnaire-WIQ|WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.|6 months||||units on a scale||Standard Deviation|Mean
2660876|NCT01575808|Secondary|Walking Impairment Questionnaire-WIQ|WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.|3 months||||units on a scale||Standard Deviation|Mean
2660877|NCT01575808|Secondary|Walking Impairment Questionnaire-WIQ|WIQ Distance Score - Higher score reflects a better quality of life（Scores range: 0 to 100.）The difficulty of walking with each specific distance(from walking indoor to 450 meter) is ranked on 0 to 4 and these rank value are converted to score according to the difficulty of walking. The distance score is determained by dividing the total score by greatest score and multiplying by 100.|1 month||||units on a scale||Standard Deviation|Mean
2660878|NCT01575808|Secondary|Vascular Quality of Life Questionnaire - VascuQOL|"VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of Activity, Symptom, Pain, Emotional and Social scores as subscales. The total score is calculated as the average value of all scores."|24 months|||||||
2660879|NCT01575808|Secondary|Vascular Quality of Life Questionnaire - VascuQOL|"VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of Activity, Symptom, Pain, Emotional and Social scores as subscales. The total score is calculated as the average value of all scores."|12 months||||units on a scale||Standard Deviation|Mean
2660880|NCT01575808|Secondary|Vascular Quality of Life Questionnaire - VascuQOL|"VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of Activity, Symptom, Pain, Emotional and Social scores as subscales. The total score is calculated as the average value of all scores."|6 months||||units on a scale||Standard Deviation|Mean
2660881|NCT01575808|Secondary|Vascular Quality of Life Questionnaire - VascuQOL|"VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of Activity, Symptom, Pain, Emotional and Social scores as subscales. The total score is calculated as the average value of all scores."|3 months||||units on a scale||Standard Deviation|Mean
2660882|NCT01575808|Secondary|Vascular Quality of Life Questionnaire - VascuQOL|"VascuQOL Score - Higher score reflects a better quality of life(Score range: 1 to 7). This score is composed of Activity, Symptom, Pain, Emotional and Social scores as subscales. The total score is calculated as the average value of all scores."|1 month||||units on a scale||Standard Deviation|Mean
2660883|NCT01575808|Secondary|Change in Ankle-Brachial Index From Baseline|Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)|Baseline and 1, 3, 6, 12, 24 months, change from baseline at 24 months presented|||||||
2660884|NCT01575808|Secondary|Change in Ankle-Brachial Index From Baseline|Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)|Baseline and 1, 3, 6, 12, 24 months, change from baseline at 12 months presented||||ABI||Standard Deviation|Mean
2660885|NCT01575808|Secondary|Change in Ankle-Brachial Index From Baseline|Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)|Baseline and 1, 3, 6, 12, 24 months, change from baseline at 6 months presented||||ABI||Standard Deviation|Mean
2660886|NCT01575808|Secondary|Change in Ankle-Brachial Index From Baseline|Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure)|Baseline and 1, 3, 6, 12, 24 months, change from baseline at 3 months presented||||ABI||Standard Deviation|Mean
2660887|NCT01575808|Secondary|Change in Ankle-Brachial Index From Baseline|Ankle-Brachial Index of each time frame (1, 3, 6, 12, 24 months) compared to baseline (pre-procedure),|Baseline and 1, 3, 6, 12, 24 months, change from baseline at 1 month presented||||ABI||Standard Deviation|Mean
2660888|NCT01575808|Secondary|Clinical Success|"The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene~The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results."|24 months|||||||
2660889|NCT01575808|Secondary|Clinical Success|"The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene~The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results."|12 months||||Participants|||Count of Participants
2660918|NCT01575808|Secondary|Percent of Participants Not Experiencing an Adverse Event|% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown|12 months|Kaplan-Meier estimate done at end of follow-up visit window|||percent of participants||95% Confidence Interval|Number
2660890|NCT01575808|Secondary|Clinical Success|"The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene~The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results."|6 months||||Participants|||Count of Participants
2660891|NCT01575808|Secondary|Clinical Success|"The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene~The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results."|3 months||||Participants|||Count of Participants
2660892|NCT01575808|Secondary|Clinical Success|"The Rutherford Classification is a system used to score Chronic Limb Ischemia in Peripheral Artery Disease (PAD). The stages follow (higher numbers are worse):~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene~The percentage of people improving by at least one stage (moving frm higher number to lower number) is listed in the results."|1 month||||Participants|||Count of Participants
2660893|NCT01575808|Secondary|Avoidance of Target Lesion Revascularization||24 months|||||||
2660894|NCT01575808|Secondary|Avoidance of Target Lesion Revascularization||12 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
2660895|NCT01575808|Secondary|Avoidance of Target Lesion Revascularization||6 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
2660896|NCT01575808|Secondary|Avoidance of Target Lesion Revascularization||3 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
2660897|NCT01575808|Secondary|Avoidance of Target Lesion Revascularization||1 month|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
2660898|NCT01575808|Secondary|Rate of Avoidance of Stent Fracture|X-ray for stent fracture evaluated by Core Lab|24 months|||||||
2660899|NCT01575808|Secondary|Rate of Avoidance of Stent Fracture|X-ray for stent fracture evaluated by Core Lab|12 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
2660900|NCT01575808|Secondary|Rate of Avoidance of Stent Fracture|X-ray for stent fracture evaluated by Core Lab|6 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
2660901|NCT01575808|Secondary|Rate of Avoidance of Stent Fracture|X-ray for stent fracture evaluated by Core Lab|3 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
2660902|NCT01575808|Secondary|Rate of Avoidance of Stent Fracture|X-ray for stent fracture evaluated by Core Lab|1 month|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
2660903|NCT01575808|Secondary|Secondary Patency|No bypass surgery and no occlusion at the target site|24 months|||||||
2660904|NCT01575808|Secondary|Secondary Patency|No bypass surgery and no occlusion at the target site|12 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
2660905|NCT01575808|Secondary|Secondary Patency|No bypass surgery and no occlusion at the target site|6 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
2660906|NCT01575808|Secondary|Secondary Patency|No bypass surgery and no occlusion at the target site|3 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
2660907|NCT01575808|Secondary|Secondary Patency|No bypass surgery and no occlusion at the target site|1 month|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
2660908|NCT01575808|Secondary|Primary Patency|Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization|24 months|||||||
2660909|NCT01575808|Secondary|Primary Patency|Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization|12 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
2660910|NCT01575808|Secondary|Primary Patency|Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization|6 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
2660911|NCT01575808|Secondary|Primary Patency|Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization|3 months|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
2660912|NCT01575808|Secondary|Primary Patency|Hemodynamic blood flow through GP1101 that had not required a target lesion revascularization|1 month|Kaplan-Meier estimate done at end of follow-up visit window|||Probability of having an event||95% Confidence Interval|Number
2660913|NCT01575808|Secondary|Technical Success|Placement of GP1101 with residual stenosis of less than 30%|Post-procedure||||Participants|||Count of Participants
2660914|NCT01575808|Secondary|Rate of Avoidance of Adverse Events|% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown|60 months|||||||
2660915|NCT01575808|Secondary|Percent of Participants Not Experiencing an Adverse Event|% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown|48 months|||||||
2660916|NCT01575808|Secondary|Percent of Participants Not Experiencing an Adverse Event|% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown|36 months|||||||
2660919|NCT01575808|Secondary|Percent of Participants Not Experiencing an Adverse Event|% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown|6 months|Kaplan-Meier estimate done at end of follow-up visit window|||percent of participants||95% Confidence Interval|Number
2660920|NCT01575808|Secondary|Percent of Participants Not Experiencing an Adverse Event|% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown at 12 months.|3 months|Kaplan-Meier estimate done at end of follow-up visit window|||Percent of participants||95% Confidence Interval|Number
2660921|NCT01575808|Secondary|Percent of Participants Not Experiencing an Adverse Event|% Avoidance of serious adverse events that are device or procedure-related or for which the relationship is unknown|1 month|Kaplan-Meier estimate done at end of follow-up visit window|||percent of participants||95% Confidence Interval|Number
2660922|NCT01575808|Secondary|Number of Participants Who Did Not Experience Any Critical Events(Death, Target Vessel Revascularization, Major Amputation of the Target Limb)|Composite endpoint of all subjects experiencing death, target vessel revascularization and/or a major amputation of the target limb (above transmetatarsals) within one month of the index procedure.|1 month||||Participants|||Count of Participants
2660923|NCT01575808|Primary|Rate of Avoidance of General Anesthesia|Percentage of study subjects avoiding general anesthesia|Day 0||||Participants|||Count of Participants
2660924|NCT01575808|Primary|Duration of Stay|Duration (in days) of post-procedure hospital stay|Up to discharge||||Days||95% Confidence Interval|Median
2660925|NCT01575808|Primary|Primary Assisted Patency|"Primary Efficacy Endpoint >~> Primary assisted patency at 12 months, defined as hemodynamic evidence by Angiography or ultrasound of flow through a device that had not required a Target Lesion Revascularization (TLR) to restore blood flow after total occlusion"|12 months||||Participants|||Count of Participants
2660926|NCT01575769|Secondary|Absolute C-Reactive Protein Levels||Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||milligrams per Liter||Standard Deviation|Mean
2660927|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Walking) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Walking component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
2660928|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Reach) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Reach component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
2660929|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Hygiene) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Hygiene component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
2660930|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Grip) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Grip component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
2660931|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Eating) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Eating component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
2660932|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Dressing and Grooming) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Dressing and Grooming component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
2660933|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Arising) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Arising component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
2660972|NCT01575522|Secondary|To Evaluate the Incidence of c-Met Positive Circulating Tumor Cells.||Baseline||||participants|||Number
2660934|NCT01575769|Secondary|Change From Baseline in CHAQ-DI (Activitiy) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Activity component was measured on 0-3 scale (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do).|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
2660935|NCT01575769|Secondary|Percentage of Participants With Minimally Important Improvement in the CHAQ-DI Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the participant must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability. A minimally important improvement was defined as at least a 0.13 improvement in CHAQ-DI score from baseline.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population|||percentage of participants||95% Confidence Interval|Number
2660936|NCT01575769|Secondary|Change From Baseline in Childhood Health Assessment - Disability Index (CHAQ-DI) at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|The CHAQ-DI, as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the participant must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||units on a scale||Standard Deviation|Mean
2660937|NCT01575769|Secondary|Change From Baseline in ESR at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up||Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||millimeters per hour (mm/hour)||Standard Deviation|Mean
2660938|NCT01575769|Secondary|Change From Baseline in PtGA of Overall Well-Being at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|The participant or parent/guardian, as appropriate, provides a rating of the participant's well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents 'very well' (ie, symptom-free and no arthritis disease activity) and the extreme right end represents 'very poor' (ie, maximum arthritis disease activity). A higher score indicates poorer well-being. A negative change score indicates improvement.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||mm||Standard Deviation|Mean
2660939|NCT01575769|Secondary|Change From Baseline in PGA of Disease Activity at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|The physician provides a rating of the participant's arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents 'arthritis inactive' (ie, symptom-free and no arthritis symptoms) and the extreme right end represents 'arthritis very active'. A higher score indicates more disease activity. A negative change score indicates improvement.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||mm||Standard Deviation|Mean
2660940|NCT01575769|Secondary|Change From Baseline in Number of Joints With Limitation of Movement at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|The maximum number of joints with limitation of movement is 67 and these were defined as those with 'limitation of motion'.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||Joints||Standard Deviation|Mean
2660941|NCT01575769|Secondary|Change From Baseline in Joints With Active Arthritis at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up|Joint with active arthritis was defined as a joint with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both.|Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)|Safety population. Here, 'n' signifies the number of participants with available data for specified category.|||Joints||Standard Deviation|Mean
2660942|NCT01575769|Secondary|Percentage of Participants With Clinical Remission at Week 12, 24 and End of Follow up|Clinical remission: inactive disease for minimum of 6 continuous months while on medication (Level 1); off oral corticosteroid medications but still on tocilizumab (Level 2); off both methotrexate and oral corticosteroids but still on tocilizumab (Level 3); or off all anti-arthritis medications-oral corticosteroids, methotrexate, non-steroidal anti-inflammatory drugs but still on tocilizumab (Level 4). Inactive disease: No joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); No fever, rash, serositis, splenomegaly, hepatomegaly (by physical exam) or generalized lymphadenopathy attributable to sJIA; Normal ESR (<20 mm/hour); PGA of disease activity indicated no disease activity (score ≤10 mm on a 100 mm VAS where 0 [inactive arthritis] and 100 [very active arthritis]). Overall percentage of participants with clinical remission (any level) are reported.|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population|||percentage of participants||95% Confidence Interval|Number
2660973|NCT01575522|Secondary|To Evaluate Phospho c-Met Expression in Archival Tumor Tissue.|MET amplification was defined as a MET/CEP7 ratio ≥ 2. Samples having a MET/CEP7 ratio from 1.5 and up to 2 were defined as having relative MET gain. Samples with a MET/CEP7 ratio of 1 but with more than two copies of each probe were defined as having polysomy of chromosome 7.|Baseline||||participants|||Number
2661045|NCT01574157|Primary|Change in Urinary Transforming Growth Factor Beta 1 (TGF-b1)|Urinary TGF-b1 is considered a marker of renal fibrosis|The mean of the 3-month and 6-month urinary TGF-b1 measurement will be compared to the baseline value between the groups.||||percent change||95% Confidence Interval|Geometric Mean
2660943|NCT01575769|Secondary|Percentage of Participants With Inactive Disease at Week 12, 24 and End of Follow up|Criteria for Inactive Disease: 1) No joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both), 2) No fever, rash, serositis, splenomegaly, hepatomegaly (by physical exam) or generalized lymphadenopathy attributable to systemic juvenile idiopathic arthritis (sJIA), 3) Normal ESR (less than [<] 20 millimeters per hour [mm/hour]), and 4) PGA of disease activity using VAS indicated no disease activity (where no disease activity is considered to be a score less than or equal to [≤]10 mm on a 100 mm VAS where left end of line 0 [inactive arthritis] to right end of line 100 [very active arthritis]).|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population|||percentage of participants||95% Confidence Interval|Number
2660944|NCT01575769|Secondary|Percentage of Participants With JIA ACR 90 Response at Weeks 12, 24 and End of Follow up|JIA ACR90 response was defined as 3 of any 6 core outcome variables improved by at least 90% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: PGA of disease activity using VAS from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); PtGA of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and ESR.|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population|||percentage of participants||95% Confidence Interval|Number
2660945|NCT01575769|Secondary|Percentage of Participants With JIA ACR 70 Response at Weeks 12, 24 and End of Follow up|JIA ACR70 response was defined as 3 of any 6 core outcome variables improved by at least 70% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: PGA of disease activity using VAS from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); PtGA of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and ESR|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population|||percentage of participants||95% Confidence Interval|Number
2660946|NCT01575769|Secondary|Percentage of Participants With JIA ACR 50 Response at Weeks 12, 24 and End of Follow up|JIA ACR50 response was defined as 3 of any 6 core outcome variables improved by at least 50% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: PGA of disease activity using VAS from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); PtGA of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and ESR.|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population|||percentage of participants||95% Confidence Interval|Number
2660947|NCT01575769|Secondary|Percentage of Participants With JIA ACR 30 Response at Weeks 12, 24 and End of Follow Up|JIA ACR30 response was defined as 3 of any 6 core outcome variables improved by at least 30% of the baseline assessments, with no more than 1 of the remaining variables worsened by more than 30%. Six core variables were: Physician global assessment (PGA) of disease activity using Visual Analog Scale (VAS) from left end of line 0 (inactive arthritis) to right end of line 100 (very active arthritis); Patient/parent global assessment (PtGA) of overall well-being using a VAS from left end of line 0 (very well) to right end of line 100 (very poor); Number of joints with active arthritis (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness or both); Number of joints with limitation of movement; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and Erythrocyte Sedimentation Rate (ESR).|Baseline, Week 12, 24, End of Follow up (up to 101 weeks)|Safety population|||percentage of participants||95% Confidence Interval|Number
2660948|NCT01575769|Primary|Percentage of Participants With Adverse Events (AEs)|AE: unfavorable and unintended sign, symptom, or disease associated with use of treatment, regardless of treatment relation. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from treatment were reported as AEs. Serious AE: resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically significant. Severe AE: AE that caused inability to work or perform normal daily activity. AEs of special interest: Serious infections (including opportunistic infections), Myocardial infarction/Acute coronary syndrome, Gastrointestinal perforations and related AE, Malignant neoplasms, Anaphylaxis event, Demyelination-related events, Stroke, Spontaneous or serious bleeding, Serious/medically significant hepatic events. Any AE included serious and non-serious AE.|Baseline to 12 weeks after last actual study medication (up to 101 weeks)|Safety population|||percentage of participants|||Number
2660974|NCT01575522|Secondary|To Evaluate c-Met Expression in Archival Tumor Tissue.|Assessment of ploidy status was done by visual screening of all tumor area; cells with maximum number of signals were recorded. MET amplification was defined as a MET/CEP7 ratio ≥ 2. Samples having a MET/CEP7 ratio from 1.5 and up to 2 were defined as having relative MET gain. Samples with a MET/CEP7 ratio of 1 but with more than two copies of each probe were defined as having polysomy of chromosome 7.|Baseline||||participants|||Number
2660975|NCT01575522|Secondary|Overall Response Using RECIST v1.1|The 95% confidence intervals should be provided. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Conventional CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >/=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 1 year||||percentage of participants||95% Confidence Interval|Number
2660949|NCT01575756|Secondary|Volume of Distribution at Steady State (Vss)|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||mL/kg||Standard Deviation|Mean
2660950|NCT01575756|Secondary|Clearance|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||mL/h/kg||Standard Deviation|Mean
2660951|NCT01575756|Secondary|Mean Residence Time (MRT)|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||h||Standard Deviation|Mean
2660952|NCT01575756|Secondary|Terminal Half-life (t½)|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||h||Standard Deviation|Mean
2660953|NCT01575756|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||h||Standard Deviation|Mean
2660954|NCT01575756|Secondary|Classical in Vivo Recovery|Classical in vivo recovery was calculated as: 100 x the maximum increase in plasma fibrinogen (fibrinogen activity assay data) within 4 hours post-treatment as compared with pre-treatment (expressed as an absolute mg/dL concentration in plasma) x the plasma volume (mL), divided by the exact dose of Octafibrin/FIBRYGA® or Haemocomplettan® P/RiaSTAP(TM) (expressed as mg).|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||percentage||Standard Deviation|Mean
2660955|NCT01575756|Secondary|Incremental in Vivo Recovery|Incremental in vivo recovery was calculated as the maximum increase in plasma fibrinogen (fibrinogen activity assay data) within 4 hours post-treatment as compared with pre-treatment (expressed as an absolute mg/dL concentration in plasma), divided by the exact dose of Octafibrin/FIBRYGA® or Haemocomplettan® P/RiaSTAP(TM) (expressed as mg/kg dosed).|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||mg/dL/(mg/kg)||Standard Deviation|Mean
2661759|NCT01566838|Primary|Number of Participants With and Without 30-Day Pain Medication Usage|The primary outcome will measure narcotics usage from post-operative day 1 through post-operative day 30.|Postoperative day 1 through postoperative day 30|30-day pain medication usage|||participants|||Number
2660956|NCT01575756|Secondary|Maximum Plasma Concentration (Cmax) Standardized|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. The maximum plasma concentration was standardized to a dose of 70 mg/kg.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses; had any post-T data; did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||g•h/L||Standard Deviation|Mean
2660957|NCT01575756|Secondary|Maximum Plasma Concentration (Cmax) Unstandardized|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||g/L||Standard Deviation|Mean
2660958|NCT01575756|Secondary|Maximum Plasma Concentration Normalized (Cmaxnorm)|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||kg•g/L/mg||Standard Deviation|Mean
2660959|NCT01575756|Secondary|Fibrinogen Activity Normalized Area Under the Curve Standardized|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. The normalized area under the curve was standardized to a dose of 70 mg/kg.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses; had any post-T data; did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||g•h/L||Standard Deviation|Mean
2660960|NCT01575756|Secondary|Fibrinogen Activity Normalized Area Under the Curve Unstandardized|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||h•kg•g/L/mg||Standard Deviation|Mean
2660961|NCT01575756|Primary|Comparison of Maximum Clot Firmness Between Octafibrin/FIBRYGA® and Haemocomplettan® P/RiaSTAP(TM) at 1 hr Post Infusion|Thromboelastometry (ROTEM®) was used to measure maximum clot firmness. Thromboelastometry is a method for the continuous measurement of clot formation. Maximum clot firmness is a functional parameter that depends on the activation of coagulation, the platelet and fibrinogen content of the blood sample, and the polymerisation and cross-linking of the fibrin network. In order to obtain comparable results from all study centres, maximum clot firmness data were assessed from frozen citrated plasma samples in a central laboratory. As these samples did not contain platelets that would be found in the whole blood assay, the fibrinogen content primarily defined the maximum clot firmness.|1 hour post-treatment|Full analysis set: All randomised participants who received at least 1 infusion of study medication (Octafibrin/FIBRYGA®) and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)) and for whom any post-treatment data were available.|||mm||95% Confidence Interval|Mean
2660976|NCT01575522|Primary|PFS Status|Analyzed using the Kaplan-Meier method. 95% confidence intervals (CI) will be determined. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Time from start of treatment to time of progression or death, assessed up to 6 months||||months||95% Confidence Interval|Median
2668473|NCT01505764|Secondary|Body Composition.|Body composition as measured by Total body nitrogen. Percentage of change day 84-baseline|day 84|only two subjects in each group completed this outcome|||percentage change||Standard Deviation|Mean
2660962|NCT01575756|Primary|Ratio of Octafibrin/FIBRYGA® to Haemocomplettan® P/RiaSTAP(TM) for Fibrinogen Activity Normalized Area Under the Curve Unstandardized|Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. The mean ratio of normalized area under the curve was calculated as Octafibrin/FIBRYGA® over Haemocomplettan® P/RiaSTAP(TM)|Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment|Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.|||ratio||90% Confidence Interval|Mean
2660963|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the SDS Total Score|The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient's life are impaired by depressive symptoms. The SDS total score is calculated as the sum of the 3 items. The SDS total score ranges from 0 to 30. Higher scores are associated with greater severity of global functional impairments. If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.|baseline, week 12 (LOCF)|only 297 of the 377 subjects had the SDS total score at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
2660964|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Depression Scale|The CGI-BP-S depression score is a single value, clinician-rated assessment of depression illness severity and range from 1=normal, not at all ill to 7=Among the most extremely ill patients. A higher score is associated with greater illness severity.|baseline, week 12 (LOCF)|only 375 of the 377 subjects had the CGI-BP-S depression assessment at Week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
2660965|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Mania Score|The CGI-BP-S mania score is a single value, clinician-rated assessment of mania illness severity and ranges from 1=Normal, not at all ill to 7= Among the most extremely ill patients. A higher score is associated with greater illness severity|baseline, week 12 (LOCF)|Only 375 of the 377 subjects had the CGI-BP-S mania assessment at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
2660966|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the CGI-BP-S Overall Score- Severity of Illness as Assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S)|Severity of illness as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) -The CGI-BP-S overall score is a single value, clinician-rated assessment of overall bipolar illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.|baseline, week 12 (LOCF)|only 375 of the 377 subjects had the CGI-BP-S overall assessment at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
2660967|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the MADRS Total Score- Depression as Assessed by Montgomery-Asberg Depression Rating Scale (MADRS)|"Depression as assessed by Montgomery-Asberg Depression Rating Scale (MADRS) -The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity of depression."|baseline ,Week 12 (LOCF)|Only 375 of the 377 subjects had the MADRS assessment at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
2660968|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the YMRS Total Score -Mania as Assessed by Young Mania Rating Scale (YMRS)|Movement disorders as assessed by Young Mania Rating Scale (YMRS) The YMRS is an 11-item instrument used to assess the severity of mania in subjects with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score). The YMRS total score is calculated as the sum of the 11 items. The YMRS total score ranges from 0 to 60. Higher scores are associated with greater severity of mania.|Baseline, 12 weeks (LOCF)|only 375 of the 377 subjects had the YMRD assessment at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
2660969|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the Positive and Negative Syndrome Scale Positive Subscale (PANSS P) Score|The PANSS-P is a subset of items in the PANSS, an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS-P subscale score is the sum of the 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.|baseline, 12 weeks (LOCF)|only 359 of the 377 subjects had the PANSS-P assessment at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
2660970|NCT01575561|Secondary|Change From Baseline to Week 12 (LOCF) in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) Total Score|The QIDS-SR16 is a 16-item self-report measure of depressive symptomatology which uses a computerized assessment interface for administration. The scoring system for the QIDS-SR16 converts responses to 16 separate items into nine DSM-IV symptom criterion domains. The nine domains comprise: depressed mood (Item 5); concentration/decision making (Item 10); self outlook (Item 11); suicidal ideation (Item 12); decreased interest (Item 13); decreased energy (Item 14); sleep disturbance (initial, middle, and late insomnia or hypersomnia) (highest score of Items 1 to 4); appetite/weight disturbance (highest score of Items 6 to 9); and psychomotor disturbance (highest score of Items 15 and 16). The QIDS-SR16 total score is calculated as the sum of the 9 domain scores. The QIDS-SR16 total score ranges from 0 to 27 with a high score indicating more severe symptoms.|baseline, 12 weeks (LOCF)|only 351 of the 377 subjects had the QIDS-SR16 assessment at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
2660971|NCT01575561|Primary|Treatment-emergent Adverse Events and Treatment-emergent Adverse Events Leading to Discontinuation and Serious Adverse Events|Number of subjects with treatment emergent AEs, SAEs, and TEAEs leading to discontinuation|12 weeks||||participants|||Number
2660978|NCT01575275|Secondary|Time to Disease Progression (TTP), Determined by Review of MRIs Performed Post Operatively as Clinically Indicated, Evaluated With Use of the New International Criteria Proposed by the Response in NeuroOncology (RANO) Committee||From the date of surgery with aminolevulinic acid to the date of progression, assessed up to 1 year|Outcome never analyzed. Closed with the IRB in 2014||||||
2660979|NCT01575275|Primary|Comparison Between the Volume of Resected Tissue (Defined as the Volume of the Resection Cavity) and the Pre-operative Enhancing Tumor Volume|Volume of enhancing tumor (initial and residual) will be determined by use of a software-based volumetric analysis method. Intra- and post-op definitions of residual tumor volume need to be adjusted for the presence of T1 hyperintensity due to signal from blood and blood products (as determined on pre-gadolinium volume study).|Up to day 1|Outcome never analyzed. Study closed with the IRB in 2014||||||
2660980|NCT01575275|Primary|Change in Volume of Residual Enhancing Tumor, as Determined by Intraoperative Volume MRI at a Single Time Point Without and With Gadolinium, Following Maximal Resection With Use of Aminolevulinic Acid|Volume of enhancing tumor (initial and residual) will be determined by use of a softwarebased volumetric analysis method. Intra- and post-op definitions of residual tumor volume need to be adjusted for the presence of T1 hyperintensity due to signal from blood and blood products (as determined on pre-gadolinium volume study).|Day 1||||cc||Full Range|Median
2660981|NCT01575197|Secondary|SAE Assessment|Serious adverse events (SAEs) occurring at anytime during the study will be measured as observed by study staff and/or reported by parent at any time. SAEs will be subcategorized according to treatment group as those deemed related to vaccination or not by an independent study monitor.|Throughout study period; Group 1: from enrollment through approximately 8 weeks of study participation, Groups 2 & 3: from enrollment through approximately 12 weeks of study participation|||||||
2660982|NCT01575197|Secondary|Vaccine-type Rotavirus Shedding in Stool|Vaccine-type rotavirus shedding in the stool at 4 (±1 day) and 7 days (±1 day) following each Rotarix vaccination will be identified using EIA for rotavirus antigens and compared to baseline levels obtained just prior to each study vaccination. If shedding in stool is detected at either time point (per manufacturer's specifications) following each Rotarix vaccination, this will be considered evidence of vaccine take.|Days 4 and 7 post each study vaccination|||||||
2660983|NCT01575197|Secondary|Baseline Immunoglobulin G (IgG) Levels: Impact on IgA Seroconversion Post-vaccination|The number and percentage of participants demonstrating IgA seroconversion post-vaccination as defined above in infants seronegative for anti-rotavirus IgA pre- vaccination using the EIA assay) by EIA pre- and post-vaccination will be compared between participants in each group who had low as compared to high rotavirus immunoglobulin G (IgG) antibody levels pre-vaccination (i.e., at 6 weeks in Groups 1 and 3 and at 10 weeks in Group 2) as measured by Enzyme linked immunosorbent assay (ELISA). Low and high IgG categories will be determined based on the IgG antibody level distribution.|Baseline, 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)|||||||
2660984|NCT01575197|Secondary|IgA GMTs: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedule|IgA GMTs measured by EIA will be compared post-vaccination between participants receiving Rotarix at 6 and 10 weeks of age and those receiving Rotarix at 10 and 14 weeks of age. For participants in Group 1, where post-vaccination response was measured at both 14 and 18 weeks of age, the highest response between these two visits was used as the final response for comparison.|4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)|Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and OPV according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results.|||titers||95% Confidence Interval|Geometric Mean
2660985|NCT01575197|Secondary|IgA Geometric Mean Titers (GMTs): 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules|IgA GMTs measured by EIA will be compared post-vaccination between participants receiving Rotarix at 6 and 10 weeks of age and those receiving Rotarix at 6, 10, and 14 weeks of age. For participants in Group 1, where post-vaccination response was measured at both 14 and 18 weeks of age, the highest response between these two visits was used as the final response for comparison.|4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)|Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and OPV according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results.|||titers||95% Confidence Interval|Geometric Mean
2660986|NCT01575197|Secondary|IgA Seroconversion: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedules|Anti-rotavirus IgA seroconversion will be defined as the detection of anti-rotavirus IgA antibodies at a concentration ≥20 U/mL post-vaccination in infants seronegative for anti-rotavirus IgA pre- vaccination as measured by EIA.|4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)|Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and OPV according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results.|||percentage of participants||95% Confidence Interval|Number
2660987|NCT01575197|Primary|Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules|Anti-rotavirus IgA seroconversion will be defined as the detection of anti-rotavirus IgA antibodies at a concentration ≥20 U/mL post-vaccination in infants seronegative for anti-rotavirus IgA pre-vaccination as measured by Enzyme Immunoassay (EIA).|4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group)|Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and oral polio vaccine (OPV) according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results.|||percentage of participants||95% Confidence Interval|Number
2661010|NCT01574703|Secondary|Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.|This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.|||percentage of participants|||Number
2660988|NCT01575106|Primary|fMRI Signal Changes in the Dorsal Anterior Cingulate Cortex|We used fMRI to investigate the signal changes associated with administration of identical pain stimuli before (pre) and after the treatment (post) with different creams in session 3. It is important to note that the subjects had multiple weeks to complete the study, but this measure was only taken during one session. The change was calculated from two time points as the value at the later time point (post treatment) minus the value at the earlier time point (pre treatment).|Week 4|The neutral cream is omitted from the data table below because we were only concerned about the direct comparison between positive expectancy (“Lidocaine”) and negative expectancy (“Capsaicin”) conditions. Data were only collected for the Lidocaine and Capsaicin creams.|||Post-Pre treatment peak beta||Standard Deviation|Mean
2660989|NCT01575106|Primary|Subjective Response to Pain (0-20 Visual Analogue Scale)|Subjects received heat pain before and after the application of a neutral cream (told one application of neutral cream was lidocaine, one was capsaicin, and one was neutral) and rated pain intensity on a 0-20 Visual Analogue Scale (0-no pain, 20-intolerable pain). We only measure this outcome measure in session 3. The pain intensity for each cream was averaged amongst all participants for both the pre and post treatment in session 3. Subjects have up to 3 weeks to complete the 3 sessions.|Weeks 1-3||||units on a scale||Standard Error|Mean
2660990|NCT01575080|Secondary|Number of Subject Responses That 'Agree' or 'Strongly Agree' With Questionnaire Statements|Subjects will complete short questionnaires to provide feedback on the labeling materials and system ease of use. Subjects may respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' 'Strongly Disagree'.|1 hour||||participants|||Number
2660991|NCT01575080|Secondary|Number of Self-Test Alternative Site (Forearm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Forearm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST forearm results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST forearm BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma).|1 hour|102 untrained subjects tested one test strip lot using the Contour TS BG Monitoring System. One subject was unable to obtain sufficient sample volume to test. Another subject's meter displayed|||Number of BG Test Results|Participants||Number
2660992|NCT01575080|Secondary|Number of Self-Test Alternative Site (Palm) Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using the Blood Glucose Monitoring System (BGMS). BGMS AST palm results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST palm BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma).|1 hour|102 untrained subjects tested one test strip lot on the Contour TS Blood Glucose Monitoring System|||Number of BG Test Results|Participants||Number
2660993|NCT01575080|Primary|Number of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<100mg/dL) or Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using the Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma).|1 hour|102 untrained subjects tested one test strip lot on the Contour TS Blood Glucose Monitoring System.|||Number of BG Test Results|Participants||Number
2660994|NCT01575054|Secondary|Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale|The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the optional muscles by passively moving the muscles through their range of motion. Optional muscles treated include: Rectus Femoris, Flexor Digitorum Longus, Flexor Hallucis Longus, and Extensor Hallucis. The scores range from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
2660995|NCT01575054|Secondary|Change From Baseline in Average Pain Score While Walking on the 11-Point Pain Scale|"The patient is asked to select a number that best describes his/her pain while walking on an 11-point scale from 0 = no pain to 10 = pain as bad as can be imagined. Patients are instructed to recall their average pain in the study limb during the 48-hour period prior to the visit. Patients with a baseline pain score >0 are included in the analyses."|Baseline, Week 6|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
2660996|NCT01575054|Secondary|Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS)|The physician-assessed GAS is an individualized, goal-oriented 6-point scale used to track functional improvement toward active and passive goals. GAS scoring ranged from −3 to 2 (−3 = worse than start; 0 = expected goal/attained the defined therapeutic goal; 2 = much more than expected/improvements clearly exceeded the defined therapeutic goal). Active and Passive Goal scores are presented.|Week 8|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
2660997|NCT01575054|Secondary|Clinical Global Impression (CGI) of Overall Change by Physician Using a 9-Point Scale|The CGI is a 9-point scale evaluating change from baseline status by the Physician. Scores range from +4 (very marked improvement) to -4 (very marked worsening). The average of the weeks 4 and 6 CGI by Physician score is used as a secondary end point. Higher scores indicate a greater improvement from baseline.|Baseline, 6 weeks|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
2661034|NCT01574248|Secondary|Number of Participants With Requirement for Intubation||T0 to T48 hours||||Participants|||Count of Participants
2661035|NCT01574248|Secondary|Number of Participants With Admission to Intensive Care Unit||T0 to T48 hours||||Participants|||Count of Participants
2660998|NCT01575054|Primary|Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale|The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the ankle flexors by passively moving the ankle plantar flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. The average of the weeks 4 and 6 MAS-B ankle change from baseline is the primary end point. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.|Baseline, 6 Weeks|Intent-to-Treat: all randomized patients who were analyzed according to randomization assignment, regardless of treatment actually received|||Scores on a Scale||Standard Deviation|Least Squares Mean
2660999|NCT01575028|Primary|Post-operative Pain Relief|Prospectively compare post-operative pain relief in pediatric patients undergoing laparoscopic appendectomy who have received either a transversus abdominis plane (TAP) block or local anesthetic infiltration by the surgeon for analgesia.|12 hours post-operatively|Due to changes in surgical technique & protocols by the general surgeons, we were only able to recruit 3 study subjects and the study was terminated. No analysis was performed.||||||
2661000|NCT01574716|Secondary|Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels||Up to approximately 3 years|The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS.|||participants|||Number
2661001|NCT01574716|Secondary|Part 2: Radiologic Progression-free Survival Rate (PFR)|Radiologic progression-free survival rate was defined as the percentage of subjects achieving radiologic PFS at the pre-specified time points.|Weeks 12, 24, 48 and 52|The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS.|||percentage of participants|||Number
2661002|NCT01574716|Secondary|Part 2: Overall Response Rate (ORR)|ORR was defined as the percentage of subjects with either a complete response (CR) or a partial response (PR) based on RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters.|From date of first dose until disease progression (up to approximately 3.5 years)|The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS.|||percentage of participants|||Number
2661003|NCT01574716|Secondary|Part 2: Overall Survival (OS)|OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause.|From date of first dose until date of death from any cause (up to approximately 3.5 years)|The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS.|||months||95% Confidence Interval|Median
2661004|NCT01574716|Secondary|Part 2: Symptomatic Progression-free Survival|PFS including symptomatic progression was defined as the time (in weeks) from the date of randomization to the date of the first observation of disease progression according to RECIST 1.1, symptomatic progression, or death due to any cause.|From date of first dose until date of first observation of disease progression, symptomatic progression, or death due to any cause (up to approximately 3 years)|The ITT population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS.|||weeks||95% Confidence Interval|Median
2661005|NCT01574716|Primary|Part 2: Radiologic Progression-free Survival (PFS)|PFS was defined as the time (in weeks) from the date of randomization to the date of first observation of disease progression according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or date of death, regardless of the cause.|From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years)|The ITT population consisted of all randomized participants and were analyzed according to the treatment assigned by the IxRS.|||weeks||95% Confidence Interval|Median
2661006|NCT01574703|Secondary|Incidence of MACE+ Assessed Until End of Study NCT01574703.|This is an adjudicated endpoint. MACE+ is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.|Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.|||percentage of participants|||Number
2661007|NCT01574703|Secondary|Incidence of MACE Assessed Until End of Study NCT01574703.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study.|Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.|||percentage of participants|||Number
2661008|NCT01574703|Secondary|Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.|This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.|||percentage of participants|||Number
2661009|NCT01574703|Secondary|Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up.|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.|||percentage of participants|||Number
2661036|NCT01574248|Primary|Time to Resolution of Angioedema|Time interval between initiation of treatment and when there is no symptom, by visual analog scale <1 cm. Data provided are for worst symptom.|48 hours||||hours||95% Confidence Interval|Median
2661011|NCT01574703|Secondary|Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug).|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.|||percentage of participants|||Number
2661012|NCT01574703|Secondary|Time to MACE Until the End of Study NCT01574703.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study. The measure type mentioned in the outcome data table is Hazard Ratio.|Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.|||Unitless||95% Confidence Interval|Number
2661013|NCT01574703|Secondary|Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up. The measure type mentioned in the outcome data table is Hazard Ratio.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days.|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.|||Unitless||95% Confidence Interval|Number
2661014|NCT01574703|Primary|Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.|This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). The measure type mentioned in the outcome data table is Hazard Ratio relative to Placebo.|Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).|The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.|||Unitless||95% Confidence Interval|Number
2661015|NCT01574651|Secondary|"Symptoms Score Reported by the Patients Using Part I Symptoms of SGRO-C"|"Part I of the SGRQ-C covers symptoms and is concerned with respiratory symptoms, their frequency and severity. Each questionnaire response has a unique empirically derived weight. A score was calculated from these weights. The lowest possible value is zero and the highest 100. A higher value corresponds to greater impairment of health status."|Baseline, Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated|||Score on a scale||Standard Deviation|Mean
2661016|NCT01574651|Secondary|FEV1 30 Min After the Morning Dose at Baseline and Week 26|FEV1 30min is the forced expiratory volume in one second measured 30 min after the morning dose.|Baseline, Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated|||Liters||Standard Deviation|Mean
2661017|NCT01574651|Secondary|Trough FEV1 at Baseline and Week 26|Trough FEV1 is the mean value of FEV1 (forced expiratory volume in one second) measured at 23:15h and 23:45h after the morning doses. The baseline value was measured at day 1 prior to the first dose.|Baseline, Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated|||Liters||Standard Deviation|Mean
2661018|NCT01574651|Secondary|Time- Event Analysis, Number of Participants With at Least One COPD Exacerbation (Moderate or Severe) During the Treatment Period|The number of participants with at least one moderate or severe COPD exacerbation. COPD exacerbations are considered to be moderate if treatment with systemic corticosteroids and/or antibiotics was required. COPD exacerbations are considered to be severe if hospitalizations were required.|Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated|||Participants|||Number
2661019|NCT01574651|Secondary|Percent of Participants With at Least One Exacerbation Requiring Hospitalization|The percent of patients with at least one severe exacerbation within the 26 weeks that required hospitalization. COPD exacerbations were considered to be severe if hospitalization were required.|Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated|||Percent of participants|||Number
2661020|NCT01574651|Secondary|Percent of Participants With at Least One Exacerbation Requiring Systemic Corticosteroids and/or Antibiotics Over 26 Weeks|The percent of participants with at least one moderate exacerbation within the 26 weeks that required systemic corticosteroids and/or antibiotics during the treatment|Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated|||Percent of participants|||Number
2661037|NCT01574183|Secondary|Marijuana Craving and Withdrawal|The Marijuana Craving Questionnaire (MCQ) is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1 (least craving) - 7 (most craving) with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. It was administered weekly to all participants. Reported here is the mean MCQ purposefulness subscale score across 8 weeks.|8 weeks||||units on a scale||95% Confidence Interval|Mean
2661038|NCT01574183|Secondary|Weekly Cannabis Use Sessions|Self-report of weekly cannabis use sessions was measured using the Time Line Followback, a calendar-based instrument designed to assess substance consumption.|8 weeks||||weekly cannabis sessions||95% Confidence Interval|Mean
2661021|NCT01574651|Secondary|Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment.|Baseline Dyspnea Index (BDI)/Transition Dyspnea Index (TDI) focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort and captures changes from baseline. BDI was measured at day 1 prior to the first dose with domain scores ranging from 0=very severe to 4=no impairment and a total score ranging from 0 to 12(best). TDI captures changes from baseline. Each domain is scored from -3=major deterioration to 3=major improvement to give an overall TDI focal score of -9 to 9. Higher numbers indicate a better score. missing values were replaced by the latest observed value (LOCF)|Week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated|||Units on a scale||Standard Deviation|Mean
2661022|NCT01574651|Secondary|St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Superiority Analysis).|SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative. Superiority of QVA 110/50 μg to tiotropium 18 μg q.d. plus formoterol 12 μg b.i.d. in terms of health related quality of life as assessed by St George's Respiratory Questionnaire (SGRQ-C) after 26 weeks of treatment|Baseline, week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated|||Score on a scale||Standard Deviation|Mean
2661023|NCT01574651|Primary|St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis).|SGRQ is a health related quality of life questionnaire consisting of 40 items in three areas: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). The total score is 0 to 100 with a higher score indicating poorer health status. For patients who completed the study but with missing SGRQ-C during treatment, the missing SGRQ-C were replaced by the last observation carried forward (LOCF). Symptom scores were expected to improve over treatment, therefore the replacement of missing values with earlier measurements did not result in overoptimistic imputation and this procedure could be regarded as conservative.|Baseline, week 26|Full analysis set (FAS): all randomized patients who received at least one dose of randomized study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned to. The FAS was used for all efficacy variables unless otherwise stated.|||Score on a scale||Standard Deviation|Mean
2661024|NCT01574612|Primary|Reporting of Adverse Events|treatment period is for 5 days and follow up visits at 7days and 21 days after first dose|day 1 to day 21||||participants|||Number
2661025|NCT01574326|Secondary|Change From Baseline (Week 0) to Week 28/Early Termination in Serum Phosphorus|Full analysis set for dose titration period (FAS-DTP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to Week 28/Early Termination was calculated.|Baseline, Week 28/Early Termination|FAS-DTP population included all treated participants with a baseline phosphorus value and at least 1 post-baseline phosphorus assessment after Week 2. Five participants (3 in sevelamer carbonate group and 2 in the placebo group) were excluded from the FAS-DTP due to no baseline phosphorus value or no phosphorus assessment after Week 2.|||mg/dL||Standard Deviation|Mean
2661026|NCT01574326|Primary|Treatment - Emergent Adverse Events (AEs)|A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs from the time of signing the informed consent through the end of the study for all participants. SAEs occurring during the 15 days following study completion or early termination were also to be collected.|Up to 32 weeks (up to 4 weeks washout period, 2 weeks FDP and 26 weeks DTP)|Analysis was performed on safety set, which included all enrolled participants who received at least 1 dose of study drug. Participants were analyzed according to actual received treatment.|||participants|||Number
2661027|NCT01574326|Primary|Change From Baseline (Week 0) to Week 2 in Serum Phosphorus|Full analysis set for fixed dose period (FAS-FDP) participants were analyzed according to their randomized treatment. The change in serum phosphorus (mg/dL) from baseline to week 2 was calculated.|Baseline, Week 2|FAS-FDP population included all treated participants with a baseline phosphorus value and at least 1 post-baseline assessment after the first dose of study drug and on or before Week 2. Three participants (1 in sevelamer carbonate group and 2 in placebo group) were excluded from FAS-FDP due to no baseline phosphorus value at week 2.|||mg/dL||Standard Deviation|Mean
2661028|NCT01574287|Secondary|Target-to-background Ratio (TBR) of Anti-3-[18F]FACBC for Blood Pool|To evaluate uptake mechanisms of anti-3-[18F]FACBC, target-to-background ratio (TBR) of anti-3-[18F]FACBC is assessed|5-10 min after intravenous bolus injection of [18F]fluciclovine||||SUVmax||Standard Deviation|Mean
2661029|NCT01574287|Primary|Detection Rate of Parathyroid Adenomas of Anti-3-[18F]FACBC Modality|Detection rate of parathyroid adenomas using anti-3-[18F]FACBC modality is assessed by comparing [18F]FACBC and surgical findings.|At approximately 1 month post scan (time of surgery and pathologic analysis)||||percentage of adenomas detected|||Number
2661030|NCT01574248|Secondary|Systolic Blood Pressure|Average of blood pressure measurements from zero to forty-eight hours provided.|T0 to T48 hours||||mmHg||Standard Deviation|Mean
2661031|NCT01574248|Secondary|Number of Participants Given Epinephrine||T0 to T48 hours||||Participants|||Count of Participants
2661032|NCT01574248|Secondary|Number of Participants Given Histamine Receptor Type 1 (H1) and Type 2 (H2) Blockers||T0 to T48 hours||||Participants|||Count of Participants
2661033|NCT01574248|Secondary|Number of Participants Given Steroids||T0 to T48 hours||||Participants|||Count of Participants
2661046|NCT01574144|Secondary|Change in Body Weight Per Unit Change in Thoracic Impedance|Change in body weight per unit change in thoracic impedance. The regression coefficients between body weight and thoracic impedance.|Discharge to 30 days post discharge|All subjects with changes of body weight and impedance from discharge to 30 days post discharge.|||lbs/Ohm||95% Confidence Interval|Mean
2661047|NCT01574144|Primary|Percentage of Participants With Health Care Utilizations|Percentage of Participants with health care utilizations. Healthcare utilizations include hospitalizations, urgent care visits and emergency department visits.|30 days post-discharge||||percent||95% Confidence Interval|Number
2661048|NCT01574105|Secondary|Transfusion Events|Transfusion events to recorded will be the number of patients receiving units of red blood cells, units of platelets, units of plasma and units of cryoprecipitate.|Data collection begins with patient arrival in the operating room and ends with discharge from the ICU (normally less than 24hrs)||||Participants|||Number
2661049|NCT01574105|Primary|Chest Tube Losses|Chest tube losses will be measured in millilitres upon arrival in the Intensive Care unit (ICU) after six hours in the ICU and total chest tube losses during the ICU stay. Chest tube losses are the amount of blood collected in a graduated chest tube collection reservoir from chest tubes placed in the patient's chest wound at the end of surgery.|Chest tube losses are recorded from departure from operating room to chest tube removal in the ICU (normally less than 24 hrs)||||millilters||Standard Deviation|Mean
2661050|NCT01574079|Secondary|Stroke Rehabilitation Assessment of Movement|The Stroke Rehabilitation Assessment of Movement (STREAM)is designed to measure mobility and motor ability after stroke. There are three subscales with 10 items each assessing the upper extremity, lower extremity, and basic mobility. Only the lower extremity and basic mobility items were used in this study. The lower extremity scores ranged from 0 - 18 with higher scores indicating a higher level of motor control. The basic mobility scores ranged from 0 - 30 with high numbers indicating a higher level of functional mobility.|measured at admission and discharge with estimated length of stay 14 days||||outcome score||Standard Deviation|Mean
2661051|NCT01574079|Secondary|Timed Up and Go|The Timed Up and Go (TUG) is used to assess balance and gait, and to estimate fall risks in patients with deficits. The participant rises from a seated position in a chair, walks 3 meters, turns around, returns to the chair, and sits down. The test is measured in seconds, with a lower number indicating a higher level of independence and the least risk for falls.|Measured at admission and discharge with estimated length of stay 14 days||||seconds||Standard Deviation|Mean
2661052|NCT01574079|Primary|Functional Independence Measure - Locomotor Score|The Functional Independence Measure (FIM)assesses level of disability and measures progress toward independence with rehabilitational intervention. The tool consists of 18 items. Only the the locomotor score was used to assess gait ability in this study. The locomotor score ranges from 1 - 7 with a higher score indicating a higher level of functional independence.|measured at admission and discharge from rehab estimated length of stay 14 days|Thirty-three participants enrolled in the study with 3 dropping out before completion. Two of these were due to medical issues, and one was discharged unexpectedly|||outcome score||Standard Deviation|Mean
2661053|NCT01573910|Primary|Microbiological Success Rate|Microbiological specimen(s) from the affected eye(s) were collected according to a protocol-defined process. Microbiological success rate is presented as the percentage of participants for which the pre-therapy pathogens at Visit 1 (Day 1) were eradicated at Day 9 TOC/Exit Visit.|Day 9|This analysis population includes all patients who received study medication, had no major protocol deviations, had bacteria present at Day 1 visit, and had baseline and TOC/exit data or early exit data.|||percentage of participants|||Number
2661054|NCT01573910|Primary|Clinical Cure Rate|Ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) were rated by the investigator on a 4-point scale, with 0=normal/absent; 1=mild; 2=moderate, and 3=severe. Clinical cure rate is presented as the percentage of participants for which the sum of the numerical scores for the 2 cardinal ocular signs of bacterial conjunctivitis was 0 at Day 9 TOC/Exit Visit.|Day 9|This analysis population includes all patients who received study medication, had no major protocol deviations, had bacteria present at Day 1 visit, and had baseline and TOC/exit data or early exit data.|||percentage of participants|||Number
2661055|NCT01573767|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the 4-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline symptom-free value is defined as the value at Visit 3 (randomization). Change from Baseline was calculated as the averaged value during the 4-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline; Week 1 up to Week 4|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
2661056|NCT01573767|Secondary|Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 4)|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline is calculated as the value of the averaged daily AM PEF over the 4-week Treatment Period (at Week 4) minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline; Week 4|ITT Population. Only those participants available at the specified time points were analyzed.|||L/min||Standard Error|Least Squares Mean
2661083|NCT01573442|Secondary|Number of Participants With Grade 3 Or Higher Adverse Events Considered At Least Possibly Related to Treatment|"The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below."|Up to 6 months|Only patients who received at least one cycle of treatment and had adverse events assessed were included in this analysis.|||Participants|||Count of Participants
2661057|NCT01573767|Secondary|Change From Baseline in Evening (PM) PEF Over the Last 7 Days of the Treatment Period (Week 4)|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline is calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline; Week 4|ITT Population. Only those participants available at the specified time points were analyzed.|||L/min||Standard Error|Least Squares Mean
2661058|NCT01573767|Secondary|Change From Baseline in Daily Morning (AM) PEF Averaged Over the 4-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 4-week Treatment Period (at Week 4) minus the Baseline value. The Baseline value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, age, and treatment group.|Baseline; Week 1 up to Week 4|ITT Population. Only those participants available at the specified time points were analyzed.|||L/min||Standard Error|Least Squares Mean
2661059|NCT01573767|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 4-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night) was recorded by the participants in a daily diary. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 4-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline is calculated as the average value during the 4-week Treatment Period minus the value at Baseline. The Baseline value is defined as the value at Visit 3 (randomization). Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline; Week 1 up to Week 4|ITT population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
2661060|NCT01573767|Secondary|Change From Baseline in Evening Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 4-week Treatment Period in Children Who Could Perform the Maneuver|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on treatment. Change from Baseline in trough FEV1 at the end of the 4-week Treatment Period was defined using the pre-dose FEV1 measurement taken at the Week 4 clinic visit. Change from Baseline was calculated as the Week 4 trough FEV1 value minus the Baseline value. The Baseline FEV1 value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline; Week 4|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2661061|NCT01573767|Primary|Change From Baseline in Daily Pre-dose Evening (PM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 4-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use each morning. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 4-week Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Phase. The analysis was performed using an analysis of covariance (ANCOVA) model with covariates of Baseline, region, sex, age, and treatment. Only those participants contributing data per the daily eDiary were analyzed.|Baseline; Week 1 up to Week 4|ITT Population: participants randomized to treatment who received >=1 dose of study medication|||Liters per minute (L/min)||Standard Error|Least Squares Mean
2661062|NCT01573624|Secondary|Mean Change From Baseline in Rescue Albuterol/Salbutamol Use of Each Treatment Period.|Short-Acting Beta2-Agonists albuterol/salbutamol was provided to participants as rescue medication, to use in morning and evening. Participants recorded number of puffs of salbutamol MDI used in last 24 hours (sum of night time and day time puffs) daily for relief of symptoms in eDiary. Mean change from baseline was calculated where, baseline was defined as measurement from (Week 0), includes Day 1 and six days immediately preceding Day 1 (for night time puffs) and seven days (for day time puffs) for each treatment period. Change from baseline values for each participant in each treatment period were differences between on-treatment week (last 7 days of each treatment period) values and the baseline week. Analysis was done using a mixed model, including treatment, period, period baseline rescue albuterol use, and mean baseline rescue albuterol use as fixed effects and participant as random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.|Baseline (Week 0) and last 7 days of each treatment period|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Number of puffs||Standard Error|Least Squares Mean
2661084|NCT01573442|Primary|Change in BPI Average Pain From Baseline to Month 1-6|Change in BPI Average Pain from baseline to month 1-6. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.|Baseline and months 1-6|Number analyzed below are based on patients who completed the BPI Average Pain item at baseline and specified month.|||score on a scale||Standard Deviation|Mean
2661760|NCT01566773|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14|Change from Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14|Day 1 through Day 14|MITT Population|||Liter||95% Confidence Interval|Least Squares Mean
2661063|NCT01573624|Secondary|Mean Change From Baseline in Daily Evening (Pre-dose and Pre-rescue Bronchodilator) PEF of Each Treatment Period|PEF is a measure of lung function and measures how fast a person can breathe out. Evening PEF was measured pre-dose and pre-rescue bronchodilator use with an electronic Peak Flow Meter. Participants were issued an electronic diary (eDiary) for daily use throughout the study and instructed on how to complete it. Best of 3 attempts were recorded in eDiary. Mean change from baseline was calculated where, baseline was defined as the measurement from (Week 0), includes Day 1 and seven days immediately preceding Day 1 for each treatment period. The change from baseline values for each participant in each treatment period were differences between on-treatment week (last 7 days of each treatment period) values and baseline week. Analysis was done using a mixed model, including treatment, period, period baseline evening PEF and mean baseline evening PEF as fixed effects and participant as a random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.|Baseline (Week 0) and last 7 days of each treatment period|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||L/min||Standard Error|Least Squares Mean
2661064|NCT01573624|Secondary|Mean Change From Baseline in Daily Morning (Pre-dose and Pre-rescue Bronchodilator) Peak Expiratory Flow (PEF) of Each Treatment Period|PEF is a measure of lung function and measures how fast a person can breathe out. Morning PEF was measured pre-dose and pre- rescue bronchodilator use with an electronic Peak Flow Meter. Participants were issued an electronic diary (eDiary) for daily use throughout the study and instructed on how to complete it. Best of 3 attempts were recorded in eDiary. Mean change from baseline was calculated where, baseline was defined as the measurement from (Week 0), includes Day 1 and six days immediately preceding Day 1 for each treatment period. The change from baseline values for each participant in each treatment period were differences between on-treatment week (last 7 days of each treatment period) values and baseline week. Analysis was done using a mixed model, including treatment, period, period baseline morning PEF and mean baseline morning PEF as fixed effects and participant as a random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.|Baseline (Week 0) and last 7 days of each treatment period|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Litres per min (L/min)||Standard Error|Least Squares Mean
2661065|NCT01573624|Primary|Mean Change From Baseline in Trough FEV1 on Day 15 of Each of the 3 Treatment Periods|FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. The highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 AM and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as the FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. The change from baseline value for each participant in each treatment period was the difference between the observed on-treatment value obtained 24 hours after morning dosing on Day 14 and the baseline value for that period. Analysis was done using a mixed model, including treatment, period, period baseline FEV1, and mean baseline FEV1 as fixed effects and participant as a random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.|Baseline (Day 1) and Day 15 of each treatment period|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Litres (L)||Standard Error|Least Squares Mean
2661066|NCT01573624|Primary|Percentage of Chance That FF 100 mcg Alone Corrected Change From Baseline FEV1 Response Would Exceed a Target Response by Dose of UMEC Combined With FF 100 mcg|FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. Highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 AM and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. Change from baseline value for each participant in each treatment period was the difference between the observed on-treatment value obtained 24 hours after morning dosing on Day 14 and the baseline value for that period. Data is presented as percentage chance that FF 100 mcg alone corrected change from baseline trough FEV1 response would exceed a target response of 50 mL, 75 mL, 100 mL and 150 mL by doses of UMEC combined with FF 100 mcg.|Baseline (Day 1) and Day 15 of each treatment period|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Percentage chance|||Number
2661067|NCT01573624|Primary|Model Predicted Change From Baseline Trough Force Expiratory Volume in 1 Second (FEV1)|FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. Highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 ante meridiem (AM) and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. Change from baseline value for each participant in each treatment period was the difference between the observed on-treatment value obtained 24 hours after morning dosing on Day 14 and the baseline value for that period. Slope-intercept on log dose model was used to predict trough FEV1 change from baseline for each of the FF+UMEC doses adjusted by FF 100 mcg alone. Mean value for the expected response and associated 95% confidence interval (CI) in change from baseline trough FEV1 is presented.|Baseline (Day 1) and Day 15 of each treatment period|The primary endpoint was analyzed using Intent -to -Treat (ITT) Population defined as all participants randomized to treatment and who received at least one dose of study medication. Only those participants with data available at the indicated time points were analyzed.|||Litres (L)||95% Confidence Interval|Mean
2661068|NCT01573533|Secondary|Number of Subjects With Complete or Partial Remission Following Treatment|"Total number of subjects with complete or partial remission following treatment using the following criteria:~Complete Remission - Proteinuria < 0.5 g/day~Partial Remission - Improvement in proteinuria by > 50% and to a level between 0.5-3.5g/day~Incomplete Remission - Improvement in proteinuria equal to or >50%, but residual proteinuria still >3.5g/day"|12 months||||Participants|||Count of Participants
2661085|NCT01573442|Primary|Change in BPI Average Change From Baseline Pain Score to Month Six Average Pain Score|Change in BPI Average Change from Baseline Pain Score to Month Six Average Pain Score. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.|Baseline and 6 months|Patients who completed item #3 (average) of the BPI at baseline and month 6 time points are included in this analysis.|||score on a scale||Standard Deviation|Mean
2661069|NCT01573533|Secondary|Change in Activation of Podocyte β3 Integrin|To quantitatively examine the effect of FSGS patient sera on podocyte β3 integrin activity, a human podocyte cell line is cultured at 37 degrees Celsius for 14 days for complete differentiation. The cells are then incubated in 5-10% of FSGS patient serum for 24 hours with recombinant suPAR protein as a positive control. Cells are fixed with 4% paraformaldehyde (PFA) and proceeded for immunofluorescence staining for AP5 and paxillin. After immunostaining, confocal images are taken to quantify the AP5 and paxillin intensity for each sample treatment. Paxillin signal is used to correct AP5 signal. The relative AP5 signal (AP5/paxillin ratio) from each patient serum is then normalized against that of normal blood donor included in each assay for final report.|Baseline, 1, 3, 6, 12 months||||AP5/paxillin ratio||Standard Deviation|Mean
2661070|NCT01573533|Secondary|Change in suPAR Levels|SuPAR concentrations will be determined by quantitative ELISA immunoassay reported in picograms per milliliters (pg/ml)|Baseline, 1, 3, 6 and 12 months||||pg/ml||Standard Deviation|Mean
2661071|NCT01573533|Primary|Changes in Proteinuria (With Stable Renal Function)|"The amount of protein in excreted urine measured by grams per day (g/day). Remission status defined by the following criteria at 12 months:~Complete Remission - Proteinuria < 0.5 g/day~Partial Remission - Improvement in proteinuria by > 50% and to a level between 0.5-3.5g/day~Incomplete Remission - Improvement in proteinuria equal to or >50%, but residual proteinuria still >3.5g/day"|Baseline, 12 months||||g/day||Standard Deviation|Mean
2661072|NCT01573442|Secondary|The Intrapatient Change in Activity Level (Interference of Activity) for Each Month From Baseline as Measured by Item#6 (Interference) of the BPI-AIA.|The intrapatient change in activity level (interference of activity) for each month from baseline as measured by item#6 (interference) of the BPI-AIA. Change in general activity from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.|baseline and month 3|Patients who completed the BPI item #6 at baseline and month 3 are included in this analysis.|||score on a scale||Standard Deviation|Mean
2661073|NCT01573442|Secondary|Change in Average Joint Stiffness From Baseline to Month 3 as Measured by BPI Item #5 (Joint Stiffness)|Change in average joint stiffness from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.|baseline and month 3|Patients who completed the BPI item #5 on joint stiffness at baseline and month 3 are included in this analysis.|||score on a scale||Standard Deviation|Mean
2661074|NCT01573442|Secondary|Change in BPI Pain Right Now From Baseline to Month 3|Change in BPI Pain right now from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.|baseline and month 3|Patients who completed the BPI pain right now item at baseline and month 3 are included in this analysis.|||score on a scale||Standard Deviation|Mean
2661075|NCT01573442|Secondary|Change in BPI Least Pain From Baseline to Month 3|Change in BPI Least Pain from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.|baseline and month 3|Patients who completed the BPI Least pain item at baseline and month 3 are included in this analysis.|||score on a scale||Standard Deviation|Mean
2661076|NCT01573442|Secondary|Change in BPI Worst Pain From Baseline to Month 3|Change in BPI Worst Pain from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.|baseline and month 3|Patients who complete the BPI Worst item at baseline and month 3 are included in this analysis.|||score on a scale||Standard Deviation|Mean
2661077|NCT01573442|Secondary|"The Change of Menopause Specific Quality of Life From Baseline to Month 3 as Measured by MENQOL How Bothered Are You by Hot Flashes"|"The change of menopause specific quality of life from baseline to month 3 as measured by MENQOL how bothered are you by Hot Flashes. This is one question from the MENQOL (Menopause-Specific Quality of Life) questionnaire. The question asks How bothered are you by hot flashes or flushes. This is collected on a scale ranging from 0=Not at all bothered t 6=Extremely bothered, with higher values being worse."|baseline and month 3||||score on a scale||Standard Deviation|Mean
2661078|NCT01573442|Secondary|The Change of Libido From Baseline to Month 3 as Measured by the MENQOL|"Change in how bothered are you by decreased sex drive from baseline to month 3. This is assessed using one question off of the MENQOL (Menopause-Specific Quality of Life) questionnaire. The question asks How bothered are you by a decrease in your sexual drive. This is collected on a scale ranging from 0=Not at all bothered to 6=Extremely bothered, with higher values being worse."|baseline and month 3|Patients who completed MENQOL libido question 'how bothered are you by decreased sex drive' at baseline and month 3 are included in this analysis.|||score on a scale||Standard Deviation|Mean
2661079|NCT01573442|Secondary|Change in Hot Flash Frequency From Baseline to Week 8|Change in hot flash frequency from baseline to week 8. Hot flash frequency is a count of the number of hot flashes per day and is a number from 0 to infinity. Higher values are worse.|baseline and week 8|Patients who completed the questionnaire at baseline and week 8 are included in this analysis.|||hot flashes/day||Standard Deviation|Mean
2661080|NCT01573442|Secondary|Number of Patients Who Reported Hirsutism Using CTCAE 4.0|The number of patients who reported hirsutism using CTCAE 4.0 is reported below for each arm by grade.|Up to 6 months|Only patients who received at least one cycle of treatment and had adverse events assessed were included in this analysis.|||Participants|||Count of Participants
2661081|NCT01573442|Secondary|Number of Patients Who Reported Acne Using CTCAE 4.0|The number of patients who reported acne using CTCAE 4.0 is reported below for each arm.|Up to 6 months|Only patients who received at least one cycle of treatment and had adverse events assessed were included in this analysis.|||Participants|||Count of Participants
2661082|NCT01573442|Secondary|Number of Patients Who Reported Alopecia Using CTCAE 4.0|The number of patients who reported alopecia using CTCAE 4.0 is reported below for each arm.|Up to 6 months|Only patients who received at least one cycle of treatment and had adverse events assessed were included in this analysis.|||Participants|||Count of Participants
2661086|NCT01573442|Primary|Improvement in BPI Average Pain From Baseline to Month 3|"2. Was there an improvement in BPI Average Pain from baseline to month 3?"|Up to 3 months||||Participants|||Count of Participants
2661269|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital|Question 3b: nights stayed in the hospital|Randomization Baseline, Weeks 4, 8, and 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Number of nights||Standard Deviation|Mean
2661087|NCT01573442|Primary|Change in Item #3 (Average) of the Brief Pain Inventory (BPI) Average Pain From Baseline to Month 3|The average change in Brief Pain Inventory (BPI) Average Pain scores between baseline and month 3 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.|From baseline to 3 months|Patients who completed item #3 (average) of the BPI at baseline and month 3 time points are included in this analysis.|||score on a scale||Standard Deviation|Mean
2661088|NCT01573325|Secondary|Percentage of Subjects With Depressive Scores Who Had a Poor HRQoL|Identify clinical characteristics such as environmental factors, patient biology, liver-disease related symptoms, functional status, general health perception, characteristics of the individual associated with perceived HRQoL in patients with low MELD scores (≤15) pre-transplant. What characteristics were found to be predictive of poor HRQoL. Tools utilized each assessed the specific variables including patient biology, liver disease symptoms, functional status, general health perception, and characteristics of the individual.|2-3 months|Entire study population was analyzed|||percentage of participants|||Number
2661089|NCT01573325|Primary|Perceived HRQoL Score. Overall Qualty of Life Index Tool Was Utilized.|Describe perceived HRQoL in patients with low MELD scores (≤15) pre-liver transplant patient population. Overall Qualty of Life Index tool was utilized. The subscales were not utilized. The unit of measurement was scores on a scale. QLI tool has a range of 0-30 for total possible score. With the higher the score the higher the HRQoL.|2-3 months|Entire study population was analyzed|||scores on a scale||Standard Deviation|Mean
2661090|NCT01573273|Secondary|Subject Cocaine Craving MRI 2|Subjects rated craving on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower craving.|Subjects rated craving immediately following the second of two MRI scans on Day 3 of 3.||||units on a scale||Standard Deviation|Mean
2661091|NCT01573273|Secondary|Subject Cocaine Craving MRI 1|Subjects rated craving on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower craving.|Subjects rated craving immediately following the first of two MRI scans on Day 2 of 3.||||units on a scale||Standard Deviation|Mean
2661092|NCT01573273|Secondary|Subject Cocaine Craving TSST|Subjects rated craving on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower craving.|Subjects rated craving immediately following a Social Stress task on Day 1 of 3.||||units on a scale||Standard Deviation|Mean
2661093|NCT01573273|Primary|Subjective Stress Response MRI 2|Subjects rated stress levels on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower stress levels.|Subjects rated stress immediately following the second of two MRI scans on Day 3 of 3.||||units on a scale||Standard Deviation|Mean
2661094|NCT01573273|Primary|Subjective Stress Response MRI 1|Subjects rated stress levels on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower stress levels|Subjects rated Stress immediately following the first of two MRI scans on Day 2 of 3.||||units on a scale||Standard Deviation|Mean
2661095|NCT01573273|Primary|Subjective Stress Response TSST|Subjects rated stress levels on a 0-10 Likert Scale where 0 is Not at All and 10 is Extremely so that lower scores indicate lower stress levels.|Subjects rated stress immediately following a Social Stress task on Day 1 of 3.||||units on a scale||Standard Deviation|Mean
2661096|NCT01573260|Secondary|Adverse Events|Adverse events will be queried week 12 through a semi structured interview querying increase in falls, fatigue, pain, cramps or pain, in addition to open-ended questions regarding other potential adverse events. Events will be rated by the patient and investigator as mild, moderate, or serious. All serious adverse events will be reported to the research ethics board|12 weeks||||percentage of participants|||Number
2661097|NCT01573260|Secondary|Exit Questionnaire|An exit questionnaire ranking level of enjoyment and overall satisfaction with their dance/exercise program, scored from 1 (strongly agree) to 5 (strongly disagree), with open questions about willingness continuing practicing tango.|12 weeks||||units on a scale||Standard Deviation|Mean
2661098|NCT01573260|Secondary|Clinical Global Impression of Change|"Completed by both the examiner and the patient, the scale is a single question Since you have enrolled in the study, how has your Parkinson's disease changed?. It will be scored as very much improved (6), much improved (5), minimally improved (4), no change (3), minimally worse (2), much worse (1), or very much worse(0)."|26 weeks||||units on a scale||Standard Deviation|Mean
2661099|NCT01573260|Secondary|Adherence to Treatment|Compliance with dance therapy will be conducted by reconfirming the regular assistance to the dance sessions at week 12, to compare how many sessions were attended by the participants. The dance instructors will keep the track of dance classes' assistance.|12 weeks||||participants|||Number
2661100|NCT01573260|Secondary|The Parkinson's Disease Questionnaire is a Quality of Life(PDQ-39)|The PDQ-39 is a quality of life index for PD. It consists of a 39-item questionnaire that asks about the impact of PD on a person's motor function, gait, mood, cognition, and activities of daily living. Patients are asked to indicate the frequency of each event by selecting one of 5 options: never/occasionally/sometimes/often/always or cannot do at all. Total score is ranging from 0 (best possible outcome) to 156 (worst possible quality of life).|26 weeks||||score||Standard Deviation|Mean
2661101|NCT01573260|Secondary|The Krupp Fatigue Severity Scale|The fatigue severity scale measures impact of fatigue with a 9-item questionnaire, with a 7-point Likert scale for each question It has been validated, and has been used in PD studies. Total score is ranging from 0 (best possible outcome) to 63 (worst possible fatigue).|26 weeks||||score||Standard Deviation|Mean
2661102|NCT01573260|Secondary|Apathy Evaluation Scale (AES)|This is a 14-item patient-rated scale which measures cognitive, emotional, and behavioural symptoms of apathy. All items are rated on a 0 to 3 Likert Scale. The original 18-item scale has been shortened by four items, and wording simplified and it was reported to have excellent psychometric properties in PD (internal consistency reliability = 0.76, test-retest 1 week r = 0.90). Total score is ranging from 0 (best possible outcome) to 42 (worst possible symptoms).|26 weeks||||score||Standard Deviation|Mean
2661103|NCT01573260|Secondary|The Beck Depression Inventory (BDI)|"The BDI is a self-administered scale of 21 items (scored 0-3) which assesses depression symptoms. The Beck Inventory is one of the most commonly-used scales for depression in PD, and a recent consensus panel of the Movement Disorders Society concluded it was a scale of first choice for assessing depression in PD. Total score for the BDI is the sum of 21 items, ranging from 0 (best possible outcome) to 63 (worst possible symptoms)"|26 weeks||||score||Standard Deviation|Mean
2661104|NCT01573260|Secondary|The Montreal Cognitive Assessment|"This tool was designed to screen for mild cognitive impairment. This includes visuospatial tests (clock drawing, trail making, cube copying), confrontation naming, attention (digit span, backwards digit span, A test, sentence repetition), tests of verbal fluency, abstraction, short term memory, and orientation. Recently, it has been used widely in PD, and demonstrates excellent sensitivity for subtle cognitive deficits. Alternate versions (7.1 to 7.3, with a randomly-distributed order) will be administered to prevent training effects. Total score for the MoCA is the sum of eight subscales, ranging from 0 (worst possible outcome) to 30 (best possible symptoms)"|26 weeks||||score||Standard Deviation|Mean
2661105|NCT01573260|Secondary|The Purdue Pegboard|The Purdue Pegboard, a test of dexterity and speed in the hands will be assessed over 1 minute. We calculate the number of pins correctly placed on the board in a minute.|26 weeks||||correct pins per 60 sec||Standard Deviation|Mean
2661106|NCT01573260|Secondary|Freezing of Gait Questionnare (FOG_Q)|Freezing of gait will be assessed using the Freezing of Gait Questionnare (FOG_Q), a 6-item tool measuring walking and freezing episodes. Higher scores indicate greater difficulty with walking and freezing. Six items each scored from 0 to 6 were summed to obtain the total score, ranging from 0 (best possible outcome) to 36 (worst possible outcome).|26 weeks||||units on a scale||Standard Deviation|Mean
2661107|NCT01573260|Secondary|Number of Participants With a Fall in the Past 3 Months Using the Falls Questionnaire From the Canadian Longitudinal Study of Aging|Falls will be assessed using an adapted version of the falls questionnaire from the Canadian Longitudinal Study of Aging focusing on the past 3 months. This questionnaire includes 2 questions to assess if the participants felt during the past year and then it assess if this fall happened within the last 3 months. If a participant answered 'yes' to both questions, then the participant screened positive for this outcome. In the results section, we reported the number of participant who answered 'Yes' to both questions.|26 weeks||||participants|||Number
2661108|NCT01573260|Secondary|MiniBESTest|Balance will be assessed using a 14-item tool measuring performance of dynamic balance tasks. This test has high interrater and test-retest reliability in PD (intraclass correlation coefficient ≥ .92 and intraclass correlation coefficient ≥.88 respectively). Total score for MiniBESTest is the sum of foursubscales, ranging from 0 (worst possible balance) to 28 (best possible balance). Lower scores indicate greater deficits in balance. Two items have right and left assessment in which the lower score is used within the total score (directions specify which to use). For research, we used of both left and right data, thus calculating data based on 32 (vs 28) points.|26 weeks||||units on a scale||Standard Deviation|Mean
2661109|NCT01573260|Primary|Severity of PD (Unified Parkinson Disease Rating Scale - UPDRS, 2008 Version)|This is the standard scale used for grading severity of PD. It starts with a patient self-administered questionnaire covering activities of daily living, motor symptoms, and non-motor domains. It also includes a systematic rated clinical interview assessing cognitive and psychiatric symptoms and motor complications of disease. A Hoehn and Yahr scale (5-point overall disease severity index) is included. Finally, there is a formal examination component (Part III) (performed in the medication 'on' state for this study). Total score for Unified Parkinson Disease Rating Scale is the sum of six subscales, ranging from 0 (best possible outcome) to 60 (worst possible symptoms)|26 weeks||||units on a scale||Standard Deviation|Mean
2661110|NCT01573000|Secondary|Time to Human Anti-Murine Antibodies (HAMA) Positivity From the First Dosimetric Dose|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants in this study were evaluated to determine whether they developed an immune response to study treatment as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I 131 tositumomab. A positive HAMA value indicates that the participant developed human anti-mouse antibodies above the HAMA assay threshold, and a negative HAMA value indicates either the absence or below threshold level of human anti-mouse antibodies.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Participants who converted from being negative for HAMA at Baseline to being positive for HAMA following treatment were evaluated.|||days||Standard Deviation|Mean
2661111|NCT01573000|Secondary|Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|"ITT-Exposed Population. All participants with Grade 3 or Grade 4 hematologic toxicities were analyzed. The n in the category titles reflects the number of participants with the indicated Grade 3 or Grade 4 hematologic toxicity."|||days||Full Range|Median
2661112|NCT01573000|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities|Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population|||participants|||Number
2661113|NCT01573000|Secondary|Nadir Values for the Hematologic Parameters Platelets and WBC Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population|||cells/microliter||Full Range|Median
2661114|NCT01573000|Secondary|Nadir Values for Hemoglobin, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population|||Grams/dL||Full Range|Median
2661445|NCT01570192|Secondary|Clinical Response|Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)|End of treatment - up to 28 days after enrollment|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.|||Participants|||Count of Participants
2661115|NCT01573000|Primary|Number of Participants With Confirmed Partial Response (PR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST confirmed PR. Confirmed PR is defined as a >=50 percent reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.|||participants|||Number
2661116|NCT01573000|Secondary|Nadir Values for ANC, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights against infection.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with hematological toxicity were evaluated.|||Cells/millimeters cubed (mm^3)||Full Range|Median
2661117|NCT01573000|Secondary|Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations|Nadir is defined as the lowest laboratory value recorded following the administration of the study medication. Time to recovery to baseline in hematologic laboratory evaluations is the time required for recovery from nadir values to baseline values. Hematologic laboratory evaluations included ANC, hemoglobin (Hb), platelets (Plt), and WBC count.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with hematological toxicity were evaluated. The numbers analyzed in the category titles reflect the number of participants with the event of interest plus the number of participants who were censored. A censored value indicates that the participant did not have the event of interest.|||days||Full Range|Median
2661118|NCT01573000|Secondary|Number of Participants With the Indicated Fatal SAEs Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants who experienced any fatal SAE were analyzed.|||participants|||Number
2661119|NCT01573000|Secondary|Number of Participants With the Indicated Serious Adverse Events (SAE) Related to Study Drug|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants who experienced any SAE were analyzed.|||participants|||Number
2661120|NCT01573000|Secondary|Number of Participants With a Time to Death From the Last Dose of Study Drug Less Than or Equal to 30 Days or More Than 30 Days|"Time to death from the last dose of study drug is the time from the last dose of study drug administered to the date of death. Deaths due to progressive disease or to another reason (Other) were not captured as serious adverse events (SAEs) and are thus not included in the SAE module."|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants who died by the completion of LTFU were analyzed.|||participants|||Number
2661121|NCT01573000|Secondary|Number of Participants With the Indicated Primary Cause of Death|"Participants were categorized according to their primary cause of death. Deaths due to progressive disease or to another reason (Other) were not captured as serious adverse events (SAEs) and are thus not included in the SAE module."|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants who died by the completion of LTFU were analyzed.|||participants|||Number
2661122|NCT01573000|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Drug-related AEs Experienced by 3 or More Participants|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with any Grade 3 or Grade 4 drug-related AEs experienced by 3 or more participants were analyzed.|||participants|||Number
2661123|NCT01573000|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 AEs Experienced by 3 or More Participants|AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with any Grade 3 or Grade 4 AEs experienced by 3 or more participants were analyzed.|||participants|||Number
2661124|NCT01573000|Secondary|Number of Participants With an Infection for Which Anti-infectives Were Administered|Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants who had an infection during the study and during the follow-up period were analyzed.|||participants|||Number
2661125|NCT01573000|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population|||participants|||Number
2661126|NCT01573000|Secondary|Number of Participants With the Indicated Drug-Related (DR) Adverse Events (AEs) Experienced by 3 or More Participants|"An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Causality of AEs was determined by the investigators as none, remote, possible, probable, or highly probable. AEs considered by the investigator as being at least remotely related to the study treatment were considered to be DR AEs. White blood cell (WBC) count and absolute neutrophil count (ANC) were measured as cells per millimeters cubed (mm^3); hemoglobin was measured in grams per deciliter (g/dL)."|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants with any drug-related adverse events were analyzed.|||participants|||Number
2661127|NCT01573000|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death by any cause.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.|||months||95% Confidence Interval|Median
2661128|NCT01573000|Secondary|MIRROR Panel Assessed Progression-free Survival|Time from the date of enrollment (the date of randomization) to the first documented progression or death.|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||months||95% Confidence Interval|Median
2661129|NCT01573000|Secondary|MIRROR Panel Assessed Time to Response (Time From the Date of Enrollment to the First Documented Response (PR, CR, CCR)|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||days||95% Confidence Interval|Median
2661130|NCT01573000|Secondary|Time to Progression of Disease or Death in Participants Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment and those who progressed/died were analyzed. Participants who experienced progression or died (n=18, 17) and participants who were censored (n=1, 2) were analyzed. A censored value indicates that the participant did not have the event of interest.|||months||95% Confidence Interval|Median
2661131|NCT01573000|Secondary|Time to Progression of Disease or Death as Assessed by the Investigator|Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Participants who experienced progression or died (n=36, 33) and participants who were censored (n=6, 3) were analyzed. A censored value indicates that the participant did not have the event of interest.|||months||95% Confidence Interval|Median
2661132|NCT01573000|Secondary|MIRROR Panel Assessments of Duration of Confirmed Response (Time From the First Documented Response to the First Documented Progression)|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||months||95% Confidence Interval|Median
2661133|NCT01573000|Secondary|MIRROR Panel Assessments of Duration of Complete Response (Time From the First Documented Response to the First Documented Progression)|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for confirmed response were analyzed.|||months||95% Confidence Interval|Median
2661337|NCT01571362|Secondary|Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for least pain at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
2661134|NCT01573000|Secondary|Duration of Response for All Confirmed Responders, Confirmed Complete Responders, and Confirmed Partial Responders|For all participants with CR, CCR, or PR, duration of response was defined as the time from first documented response to first documented progression. All confirmed responders included participants with CR, CCR, and PR, whereas confirmed complete responders included participants with CR and CCR.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for CR, CCR, or PR were analyzed.|||months||95% Confidence Interval|Median
2661135|NCT01573000|Secondary|Number of Participants (Par.) With a Confirmed Response (CR, CCR, or PR) as Assessed by the MIRROR Panel|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
2661136|NCT01573000|Primary|Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator|Confirmed PR is defined as a >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
2661137|NCT01573000|Primary|Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST for CR + CCR.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.|||participants|||Number
2661138|NCT01573000|Primary|Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator|CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 cm in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations. If the extent of disease was unchanged or if further decreases occurred for 6 months or longer, the participant was reclassified as having a CR.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
2661139|NCT01573000|Primary|Number of Participants With Confirmed Clinical Complete Response (CCR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST for CCR. CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 cm in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.|||participants|||Number
2661140|NCT01573000|Primary|Number of Participants With Confirmed Clinical Complete Response (CCR) as Assessed by the Investigator|CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =<2 cm in diameter by radiographic evaluation or =<1 cm in diameter by physical examination can be considered scar tissue.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
2661141|NCT01573000|Primary|Number of Participants With Confirmed Complete Response (CR) Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease were assessed separately before and after receiving the crossover treatment of I 131 TST for CR. CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.|||participants|||Number
2661142|NCT01573000|Primary|Number of Participants (Par.) With a Confirmed Complete Response as Assessed by the Masked Independent Randomized Radiology and Oncology Review (MIRROR) Panel|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|The MIRROR panel reviewed responses of participants from 17 July 1998 to 17 January 2001|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
2661143|NCT01573000|Primary|Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator|CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
2661144|NCT01573000|Primary|Number of Participants With Confirmed Response Before and After Crossover From Unlabeled TST to TST and Iodine I 131 TST as Assessed by the Investigator|Participants receiving Unlabeled TST with progressive disease (defined as a >=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measureable lesions or the appearance of any new lesion. Individual lesions must be >2 centimeters [cm] in diameter by radiographic evaluation or >1 cm in diameter by physical examination.) were assessed separately before and after receiving the crossover treatment of I 131 TST for confirmed response, which included participants with CR, CCR, and PR.|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|ITT-Exposed Population. All participants receiving Unlabeled TST who received the crossover treatment were analyzed.|||participants|||Number
2661145|NCT01573000|Primary|Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants were evaluated for up to two years in Study BEX104515 and for up to 11.9 years in Study BEX104526.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
2661146|NCT01572948|Secondary|Induced Sputum Neutrophil Count||3 months after baseline||||percentage of sputum neutrophils||Standard Error|Mean
2661147|NCT01572948|Secondary|Induced Sputum Neutrophil Count||baseline||||percentage of sputum neutrophils||Standard Error|Mean
2661148|NCT01572948|Primary|Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization||3 months after baseline||||ng/ml||Standard Deviation|Mean
2661149|NCT01572948|Primary|Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization.||1 month after baseline||||ng/ml||Standard Deviation|Mean
2661150|NCT01572948|Secondary|Induced Sputum Neutrophil Count||1 month||||percentage of sputum neutrophils||Standard Error|Mean
2661151|NCT01572948|Primary|Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline||baseline||||ng/ml||Standard Deviation|Mean
2661152|NCT01572922|Secondary|Transferrin Saturation Measurements|Iron Transferrin Saturation in % measurements Transferrin Saturation measurements from eligible patients had 1.5T R2*-UTE and serum iron and transferrin saturation measurements.|Up to 30 days after MRI|Iron-overloaded patients had 1.5T R2*-UTE and serum iron and transferrin saturation measurements.|||percentage||Full Range|Median
2661153|NCT01572922|Secondary|Serum Iron Measurements Compared With 1.5T R2* UTE|Serum iron measurements from eligible patients had 1.5T R2*-UTE and serum iron and transferrin saturation measurements.|Up to 30 days after MRI|Iron-overloaded patients had 1.5T R2*-UTE and serum iron and transferrin saturation measurements.|||ug/dL||Full Range|Median
2661154|NCT01572922|Secondary|R2* Using 1.5T UTE Technique for Patients With Serum Iron and Transferrin Saturation Measurements|"MRI-derived R2* value using 1.5T R2*-UTE in Hz for patients who have had serum iron and transferrin saturation measurements. R2* is a measure obtained with MRI, i.e., MRI R2*. It is measured in hertz (Hz). In lay terms, the MRI machine picks up a signal back from the tissue during the process of scanning the tissues. With every picture taken, this signal is strong in the beginning and then wanes off. R2* reflects how fast the signal wanes off. If there is too much iron in the tissue, the signal disappears faster, making the T2* value low. T2* is the reciprocal of R2* (R2*= 1/T2*). So, if the signal drops fast, the T2* is low and the R2* is high. In this study, we are measuring the R2* value. The higher the R2*, the more iron in the liver tissue. We can compare the R2* value with that of a liver biopsy to then use the R2* value to tell us how much iron is in the liver without having to biopsy the liver."|Up to 30 days after MRI|1.5T R2*-UTE from eligible patients who had 1.5T R2*-UTE, serum iron, and transferrin saturation measurements.|||Hz||Full Range|Median
2661155|NCT01572922|Secondary|MRI Derived R2* Using 1.5T UTE Technique|"MRI-derived R2* value using 1.5T R2*-UTE in Hz. R2* is a measure obtained with MRI, i.e., MRI R2*. It is measured in hertz (Hz). In lay terms, the MRI machine picks up a signal back from the tissue during the process of scanning the tissues. With every picture taken, this signal is strong in the beginning and then wanes off. R2* reflects how fast the signal wanes off. If there is too much iron in the tissue, the signal disappears faster, making the T2* value low. T2* is the reciprocal of R2* (R2*= 1/T2*). So, if the signal drops fast, the T2* is low and the R2* is high. In this study, we are measuring the R2* value. The higher the R2*, the more iron in the liver tissue. We can compare the R2* value with that of a liver biopsy to then use the R2* value to tell us how much iron is in the liver without having to biopsy the liver."|up to 30 days after MRI|Iron-overloaded patients had 1.5T R2*-UTE-measurement.|||HZ||Full Range|Median
2661156|NCT01572922|Secondary|MRI-derived R2* Using 1.5T GRE Technique|"MRI-derived R2* Using 1.5T GRE Technique in Hz. R2* is a measure obtained with MRI, i.e., MRI R2*. It is measured in hertz (Hz). In lay terms, the MRI machine picks up a signal back from the tissue during the process of scanning the tissues. With every picture taken, this signal is strong in the beginning and then wanes off. R2* reflects how fast the signal wanes off. If there is too much iron in the tissue, the signal disappears faster, making the T2* value low. T2* is the reciprocal of R2* (R2*= 1/T2*). So, if the signal drops fast, the T2* is low and the R2* is high. In this study, we are measuring the R2* value. The higher the R2*, the more iron in the liver tissue. We can compare the R2* value with that of a liver biopsy to then use the R2* value to tell us how much iron is in the liver without having to biopsy the liver."|Up to 30 days after MRI|Iron-overloaded patients had 1.5T R2*-GRE measurements.|||Hz||Full Range|Median
2661176|NCT01572740|Secondary|Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 36|Estimated mean change from baseline in mean prandial PG increment of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 36 Weeks of treatment.|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 13 subjects did not contribute to the statistical analysis at Week 36 due to missing data.|||mmol/L||Standard Error|Mean
2661157|NCT01572922|Primary|MRI-derived R2* Values Using 1.5T UTE Technique|"Hepatic iron content of the liver using MRI-derived 1.5T R2*-UTE measurement, with results in Hz. R2* is a measure obtained with MRI, i.e., MRI R2*. It is measured in hertz (Hz). In lay terms, the MRI machine picks up a signal back from the tissue during the process of scanning the tissues. With every picture taken, this signal is strong in the beginning and then wanes off. R2* reflects how fast the signal wanes off. If there is too much iron in the tissue, the signal disappears faster, making the T2* value low. T2* is the reciprocal of R2* (R2*= 1/T2*). So, if the signal drops fast, the T2* is low and the R2* is high. In this study, we are measuring the R2* value. The higher the R2*, the more iron in the liver tissue. We can compare the R2* value with that of a liver biopsy to then use the R2* value to tell us how much iron is in the liver without having to biopsy the liver."|Up to 30 days after MRI|Eligible iron-overloaded patients with both liver biopsy measurement and 1.5T R2*-UTE measurement.|||Hz||Full Range|Median
2661158|NCT01572922|Primary|Hepatic Iron Content in the Liver Using Liver Biopsy|Hepatic iron content in the liver using liver biopsy|up to 30 days after MRI|Eligible iron-overloaded patients with both liver biopsy measurement and 1.5T R2*-UTE measurement.|||mcg||Full Range|Median
2661159|NCT01572844|Secondary|Change in Patient Functionality and/or Quality of Life.|This will be assessed through the use of the Dermatology Life Quality Index (DLQI), Health Assessment Questionnaire (HAQ)/Childhood Health Assessment Questionnaire (CHAQ), Manual Muscle Testing (MMT8), and range of motion evaluations. DLQI index scores range from 0 to 30. The higher the score, the more quality of life is impaired.Change in scores from baseline to final assessment yielding a negative percent change indicate an improvement in DLQI. HAQ scales range from 0 to 3. The higher the score, the greater the disability. Change in scores from baseline to final assessment yielding a negative percent change indicate an improvement in the HAQ. MMT8 testing results in a score between 0 and 150. The higher the score, the more normal the function of the muscle. A positive percent change would indicate an improvement in MMT8 testing results.|Change from Visit 1 to Visit 12 (week 20)|The arms/groups does not apply to this outcome measure. Lesions were not analyzed in these assessments. Overall Patient functionality and quality of life were evaluated via questionnaires, manual muscle testing, and range of motion evaluations. No changes in range of motion were noted for either subject.|||percentage of change from baseline|||Number
2661160|NCT01572844|Secondary|Change in Size of Dermatomyositis-associated Calcinosis Area on Lesions as Measured by a Difference in Plain Film (X-ray) Studies.|Change in dermatomyositis-associated calcinosis as measured by a difference in centimeters in plain film (x-ray) studies. X rays were compared between baseline and final assessment for any changes.|Change from Visit 2 to Visit 12 (week 20)|No change was observed for any lesion.|||cm|lesion|Standard Deviation|Mean
2661161|NCT01572844|Secondary|Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Patient Calcinosis Visual Analog Scales.|Change in dermatomyositis-associated calcinosis of a single lesion by assessing its severity as measured by a difference in Patient Calcinosis Visual Analog Scales. The scale ranges from zero (0) to ten (10). Zero (0) being no evidence of disease activity and ten (10) being extremely active or severe disease activity. A negative change would indicate improvement in the disease activity. A positive change would indicate worsening of disease activity.|Change from Visit 2 to Visit 12 (week 20)||||Percentage of change|lesions||Number
2661162|NCT01572844|Secondary|Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Hardness as Measured by a Difference in Durometer (Rex Durometer Model 1600, Type OO) Measurements.|Change in dermatomyositis-associated calcinosis of a single lesion by assessing its hardness as measured by a difference in durometer (Rex durometer Model 1600, Type OO) measurements. The range of a durometer is from 0 to 100. The higher the durometer reading, the harder the lesion. Improvement in the lesion hardness would result in a negative change over time.|Change from Baseline (Visit 1) at Final Assessment (Visit 12, week 20).|2 subjects were enrolled and each subject has 2 lesions that were followed through the study. Each subject has one area that was marked as treatment lesion and also has an area that was used as a control (no treatment lesion). Overall, there were 2 subjects, 2 treatment lesions and 2 no treatment lesions.|||percentage of change|lesions||Number
2661163|NCT01572844|Primary|Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Physician Calcinosis Visual Analog Scales.|Change in dermatomyositis-associated calcinosis of a single lesion by assessing its severity as measured by a difference in Physician Calcinosis Visual Analog Scales. The Visual Analog Scale range is from zero (0) to ten (10). Zero (0) being no evidence of disease activity and ten (10) being extremely active or severe disease activity. A negative percent change indicates improvement in the lesion.|Change from Visit 2 to Visit 12 (week 20)||||percentage change|lesion||Number
2661164|NCT01572792|Secondary|Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Vital Signs (Pulse Rate, Systolic or Diastolic Blood Pressure or Weight)|"Potentially clinically significant change:~Systolic BP ≥180 mmHg and increase ≥20 mmHg from baseline or ≤90 mmHg and decrease ≥20 mmHg from baseline Diastolic BP ≥105 mmHg and increase ≥15 mmHg from baseline or ≤50 mmHg and decrease ≥15 mmHg from baseline Pulse rate ≥110 bpm and increase ≥15% from baseline or ≤50 bpm and decrease ≥15% from baseline Weight increase or decrease ≥7% from baseline~The last assessment made before the first dose of investigational product in the lead-in study was used as the baseline for all safety analyses in the extension study"|Baseline of lead-in study to end of treatment (up to Week 52)|The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study|||Percentage of participants|||Number
2661165|NCT01572792|Other Pre-specified|Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score|St George's Respiratory Questionnaire (SGRQ) measures COPD-specific health outcomes and consists of 3 dimension scores (symptom, activity and impact). SGRQ total score is the sum of these scores and ranges from 0 (best health status) to 100 (worst health status).|Baseline of lead-in study to Week 52 of treatment|The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31|||Scores on a scale||Standard Error|Least Squares Mean
2661166|NCT01572792|Other Pre-specified|Transition Dyspnea Index (TDI) Focal Score at End of Study|"The TDI measures the change from baseline in severity of breathlessness in symptomatic patients. The TDI contains a rating for 3 categories (functional impairment, magnitude of task, magnitude of effort). TDI scale ranges from -3 (major deterioration) to +3 (major improvement) including a 0 score to indicate no change. The 3 categories are added to obtain a focal score ranging from -9 (including 0) to +9."|Baseline of lead-in study to Week 52 of treatment|The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31|||Scores on a scale||Standard Error|Least Squares Mean
2661167|NCT01572792|Other Pre-specified|Change From Baseline in Morning Predose (Trough) Forced Expiratory Volume in One Second (FEV1)||Baseline of lead-in study to Week 52 of treatment|The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31|||Liters||Standard Error|Least Squares Mean
2661168|NCT01572792|Other Pre-specified|Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)||Baseline of lead-in study to Week 52 of treatment|The Combined intent to treat (ITT) Population defined as all patients randomized to a treatment group who took at least 1 dose of double-blind investigational product in the lead-in study (LAC-MD-31) and who had a baseline assessment and at least 1 post-baseline assessment of forced expiratory volume in 1 second (FEV1) in LAC-MD-31|||Liters||Standard Error|Least Squares Mean
2661169|NCT01572792|Secondary|Percentage of Patients to Experience a Potentially Significant Post-baseline 12-lead ECG Value||Baseline of lead-in study to end of treatment (up to Week 52)|The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study|||Percentage of participants|||Number
2661170|NCT01572792|Secondary|Percentage of Patients to Experience Potentially Clinically Significant Post-baseline Clinical Laboratory Values for Hematology, Chemistry or Urinalysis|"Potentially clinically significant change:~>1.15 × upper limit of normal (ULN) for absolute cell count of basophils, eosinophils or monocytes, blood alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total bilirubin, blood urea nitrogen, total cholesterol, creatine kinase, creatinine, gamma glutamyl transferase, lactate dehydrogenase, triglycerides or uric acid <0.85 x lower limit of normal (LLN) or > 1.15 ULN for hematocrit ratio, haemoglobin, lymphocytes or neutrophils absolute cell count, platelet count (thrombocytes), red or white blood cell count, calcium, fasting glucose, phosphorus, total protein, or urinary pH <0.95 x LLN or >1.05 x ULN for chloride, potassium, sodium Urinary glucose ≥0.015, blood or ketones or protein ≥1 or specific gravity >1.1 × ULN~The last assessment made before the first dose of investigational product in the lead-in study was used as the baseline for all safety analyses in the extension study"|Baseline of lead-in study to end of treatment (up to Week 52)|The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study|||Percentage of participants|||Number
2661171|NCT01572792|Primary|Percentage of Patients to Experience Any Treatment-emergent Adverse Event|For each safety parameter, the last assessment made before the first dose of investigational product in the lead-in study (LAC MD-31) was used as the baseline for all analyses of that safety parameter in this extension study|Baseline of lead-in study to follow-up call 14±3 days after last dose of investigational product (up to Week 52)|The Extension Safety Population defined as all patients from the lead-in study (LAC-MD-31) who signed informed consent at Visit 1 of this extension study (last visit of the lead-in study) and who took at least 1 dose of double-blind investigational product in this extension study|||Percentage of participants|||Number
2661172|NCT01572740|Secondary|Number of Confirmed Hypoglycaemic Episodes|"A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and until the last day on randomised treatment. Confirmed hypoglycaemic episode was defined as hypoglycaemic episodes categorised to severe and/or minor hypoglycaemic episodes.~Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded PG < 3.1 mmol/L (56 mg/dL). Minor: PG < 3.1 mmol/L (56 mg/dL)."|Week 0 to week 36 (inclusive)|Safety analysis set includes all subjects who received at least one dose of the trial products.|||Episodes/100 years of patient exposure|||Number
2661173|NCT01572740|Secondary|Number of Adverse Events (AEs)|An AE was defined as treatment emergent if the onset date was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.|Week 0 to Week 36 (inclusive)|Safety analysis set includes all subjects who received at least one dose of the trial products.|||Events/100 years of patient exposure|||Number
2661174|NCT01572740|Secondary|Change in Body Weight From Baseline to Week 36|Estimated mean change in body weight after 36 Weeks of treatment|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 36 as subject was withdrawn from the trial before sampling for any efficacy data.|||kg||Standard Error|Mean
2661175|NCT01572740|Secondary|Change in Body Weight From Baseline to Week 16|Estimated mean change in body weight after 16 Weeks of treatment|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 16 as subject was withdrawn from the trial before sampling for any efficacy data.|||kg||Standard Error|Mean
2661210|NCT01572675|Primary|Duration of Prescription for Arcoxia® and Celebrex® at Enrollment|The mean duration of prescription at enrollment for participants treated with Arcoxia® and Celebrex® was determined using the participant's record.|Up to 3 months prior to study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (duration of prescription)|||Days||Standard Deviation|Mean
2661177|NCT01572740|Secondary|Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16|Estimated mean change from baseline in mean prandial PG increment of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment.|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 9 subjects did not contribute to the statistical analysis at Week 16 due to missing data.|||mmol/L||Standard Error|Mean
2661178|NCT01572740|Secondary|Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36|Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 36 Weeks of treatment.|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 8 subjects did not contribute to the statistical analysis at Week 36 due to missing data.|||mmol/L||Standard Error|Mean
2661179|NCT01572740|Secondary|Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16|Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment.|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 9 subjects did not contribute to the statistical analysis at Week 16 due to missing data.|||mmol/L||Standard Error|Mean
2661180|NCT01572740|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36|Estimated mean change from baseline in FPG after 36 Weeks of treatment.|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 36 as subject was withdrawn from the trial before sampling for any efficacy data.|||mmol/L||Standard Error|Mean
2661181|NCT01572740|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16|Estimated mean change from baseline in FPG after 16 Weeks of treatment.|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 16 as subject was withdrawn from the trial before sampling for any efficacy data.|||mmol/L||Standard Error|Mean
2661182|NCT01572740|Secondary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36|Estimated mean change from baseline in HbA1c after 36 Weeks of treatment|Week 0, Week 36|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 36 as subject was withdrawn from the trial before sampling for any efficacy data.|||percentage of glycosylated haemoglobin||Standard Error|Mean
2661183|NCT01572740|Primary|Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16|Estimated mean change from baseline in HbA1c after 16 Weeks of treatment.|Week 0, Week 16|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products. Missing data were imputed using last observation carried forward (LOCF). 1 subject in the placebo group did not contribute to the statistical analysis at Week 16 as subject was withdrawn from the trial before sampling for any efficacy data.|||percentage of glycosylated haemoglobin||Standard Error|Mean
2661184|NCT01572727|Secondary|Time to Definitive Deterioration of ECOG Performance Status (Phase Lll)|Time to definitive deterioration of the ECOG performance status from baseline|every 4 weeks|PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, the time to definitive deterioration of ECOG performance status was removed as a secondary endpoint in the final analysis and consequently not analyzed.||||||
2661185|NCT01572727|Secondary|Plasma Concentration-time Profiles of BKM120 - Pharmacokinetics (PK) (Phase Lll)|Summary statistics for PK: plasma concentration-time profiles of BKM120 and appropriate individual PK parameters based on population PK model , if deemed appropriate; each cycle = 28 days|Cycle 1 day 1, 15, 16, 22 and Cycle 2 day 1.|PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, the plasma concentration-time profiles was removed as a secondary endpoint in the final analysis and consequently not analyzed.||||||
2661186|NCT01572727|Secondary|Clinical Benefit Rate (CBR) (Phase ll)|CBR was defined as the percentage of patients with an overall response of CR or PR or SD or non-CR/non-PD lasting more than 24 weeks based on local Investigator's assessment according to RECIST v1.1.|every 8 weeks after randomization Up to 3 months after end of Treatment|FAS per Expert Report: All pts randomized to study treatment. Per ITT principle, pts were analyzed according to treatment & strata. FAS was primary population for analysis of efficacy endpoints at interim. 338 pts were randomized (between 16-Aug-2012 & 07-Jun-2014) in 1:1 ratio to buparlisib + paclitaxel arm N=168 or placebo + paclitaxel arm N=170.|||Percentage of participants||95% Confidence Interval|Number
2661187|NCT01572727|Secondary|Time to Response (Phase Lll)|time from date of randomization until first documented response (CR or PR, which has to be confirmed subsequently).|every 8 weeks after randomization Up to 3 months after end of Treatment|PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, time to response was removed as a secondary endpoint in the final analysis and consequently not analyzed.||||||
2661188|NCT01572727|Secondary|Duration of Response (Phase Lll)|time from the date of the first documented response (CR or PR, which had to be confirmed subsequently) to the date of the first radiologically documented disease progression or death due to disease|every 8 weeks after randomization Up to 3 months after end of Treatment|PFS, ORR and CBR were analyzed and reported at the interim analysis. Given the study met the futility analysis per protocol, the duration of response was removed as a secondary endpoint in the final analysis and consequently not analyzed.||||||
2662589|NCT01561313|Secondary|Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale|Hemorrhage/petechiae (bleeding/spots of bleeding underneath the skin) was assessed.|10 minutes and 30 minutes after injection||||Percentage of Participants|||Number
2661189|NCT01572727|Secondary|Overall Response Rate (Phase ll)|Percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST v1.1. According to this criteria, CR = at least two determinations of CR at least 4 weeks apart before progression; PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|every 8 weeks after randomization Up to 3 months after end of Treatment|FAS per Expert Report: All pts randomized to study treatment. Per ITT principle, pts were analyzed according to treatment & strata. FAS was primary population for analysis of efficacy endpoints at interim. 338 pts were randomized (between 16-Aug-2012 & 07-Jun-2014) in 1:1 ratio to buparlisib + paclitaxel arm N=168 or placebo + paclitaxel arm N=170.|||Percentage of participants||95% Confidence Interval|Number
2661190|NCT01572727|Secondary|Overall Survival by Kaplan-Meier Estimate (Phase ll)|Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last contact.|every 3 months until death, lost to follow-up, or withdrawal of consent to survival follow-up, up to 10 months after futility was analyzed|Full analysis set (FAS) comprises all patients who were randomized to study treatment.|||Months||95% Confidence Interval|Median
2661191|NCT01572727|Primary|Progression-free Survival (PFS)Assessed by Local Investigator's Assessment (Phase ll)|PFS was defined as the time from the date of randomization to the date of the event, defined as the first radiologically documented disease progression or death due to any cause. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Every 8 weeks from randomization until disease progression up to 10 months after futility was analyzed|FAS per Expert Report: All pts randomized to study treatment. Per ITT principle, pts were analyzed according to treatment & strata. FAS was primary population for analysis of efficacy endpoints at interim. 338 pts were randomized (between 16-Aug-2012 & 07-Jun-2014) in 1:1 ratio to buparlisib + paclitaxel arm N=168 or placebo + paclitaxel arm N=170.|||Months||95% Confidence Interval|Median
2661192|NCT01572675|Secondary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to 12 months|The safety population consisting of all participants who enrolled in the study|||Participants|||Number
2661193|NCT01572675|Secondary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Up to 12 months|The safety population consisting of all participants who enrolled in the study|||Participants|||Number
2661194|NCT01572675|Secondary|Number of Participants With Contraindications for Use of Arcoxia®|Participants noted with contraindications for use of Arcoxia® according to the MA during initiation of treatment are described. CHF = congestive heart failure. HA = hepatic impairment. IBD = inflammatory bowel disease. IHD = ischemic heart disease. PAD = peripheral artery disease.|At study entry|The safety population consisting of all participants who enrolled in the study with data of sufficient quality for analysis of the endpoint (contraindications)|||Participants|||Number
2661195|NCT01572675|Secondary|Number of Participants Switching to Another Treatment With the Same Reason for Prescription|Participants who switched to another NSAID or other therapy for the same reason for prescription upon discontinuation of treatment with Arcoxia® or Celebrex® were determined.|Up to 12 months|All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.|||Participants|||Number
2661196|NCT01572675|Secondary|Number of Participants Treated With Other Agents Prior to Initiation of Arcoxia® and Celebrex®|Other prescribed agents for the same study indication within 3 months preceding the decision to initiate treatment with selective COX-2 inhibitors (Arcoxia® or Celebrex®) were determined using the participant's medical record. NSAIDS = Non-steroidal inflammatory agents.|Up to 3 months prior to study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (other prior agents)|||Participants|||Number
2661197|NCT01572675|Secondary|Medications Co-Prescribed Over the Course of Follow-up With Arcoxia® and Celebrex®|Concomitant medications prescribed during the course of follow-up to participants treated with Arcoxia® and Celebrex® were extracted from participants' medical records. NSAIDS = Non-steroidal anti-inflammatory agents.|Up to 12 months|All participants in compliance with study inclusion criteria with at least one follow-up visit (with an available prescription file) other than the end-of-study visit were used for analysis of the endpoint|||Participants|||Number
2661198|NCT01572675|Secondary|Medications Co-Prescribed at Study Entry in Participants Treated With Arcoxia® and Celebrex®|Concomitant medications prescribed to participants treated with Arcoxia® and Celebrex® were collected via the physician prescription note at time of participant's study entry. NSAIDS = Non-steroidal anti-inflammatory agents.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (co-prescriptions at entry)|||Participants|||Number
2661235|NCT01571453|Secondary|Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10)||Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.|||percentage of patients|||Number
2661236|NCT01571453|Secondary|MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline)||Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.|||percentage of patients|||Number
2661199|NCT01572675|Secondary|Significant Past Treatments Prior to Initiating Treatment With Arcoxia® or Celebrex®|'Significant' treatments that preceded the use of selective COX-2 inhibitors (Arcoxia® or Celebrex®) were identified using a closed-ended (yes/ no/ do not know) questionnaire. Significant is defined as associated with a chronic disease or having a potential link with participant's current use of a selective COX-2 inhibitors (Arcoxia® or Celebrex®). ARBs = Angiotensin 2 receptor blockers. ACEIs = Angiotensin-converting enzyme inhibitors. SSRIs = Selective serotonin reuptake Inhibitors. PAIs = Platelet aggregation inhibitors.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (past treatments)|||Participants|||Number
2661200|NCT01572675|Secondary|Co-morbidities in Participants Treated With Arcoxia® and Celebrex®|Associated co-morbidities at study entry (baseline) in participants treated with Arcoxia® or Celebrex® were recorded by the Investigating Physician. CHF/IHD/PAD = Congestive heart failure/Ischemic heart disease/Peripheral artery disease|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (co-morbidities)|||Participants|||Number
2661201|NCT01572675|Secondary|Medical History of Participants Treated With Arcoxia® and Celebrex®|Relevant medical history of participants treated with Arcoxia® or Celebrex® was recorded by the Investigating Physician.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (medical history)|||Participants|||Number
2661202|NCT01572675|Secondary|Blood Pressure at Study Entry in Participants Treated With Arcoxia® and Celebrex®|Participants' BP (SBP/DBP) was assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.|At study entry (baseline)|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (BP)|||Participants|||Number
2661203|NCT01572675|Secondary|Mean Systolic and Diastolic Blood Pressure (BP) at Study Entry in Participants Treated With Arcoxia® and Celebrex®|Mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) were assessed at study entry by the Investigating Physician. Definition of controlled BP: SBP <140 mmHg and DBP <90 mmHg. Definition of uncontrolled BP: SBP ≥140 mmHg and/or DBP ≥90 mmHg.|At study entry (baseline)|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (SBP and DBP)|||mmHG||Standard Deviation|Mean
2661204|NCT01572675|Secondary|Mean Body Mass Index (BMI) at Study Entry in Participants Treated With Arcoxia® and Celebrex®|Participants' BMI was assessed at study entry by the Investigating Physician. BMI is calculated as the participant's weight in kilograms (kg) divided by height in meters squared. BMI under 18.5 is commonly considered underweight; within the range (18.5 to 25) as normal weight; within the range (25 to 30) as overweight; and over 30 as obese.|At study entry (baseline)|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (BMI)|||kg/m^2||Standard Deviation|Mean
2661205|NCT01572675|Primary|Type of Arcoxia® and Celebrex® Use According to Duration of Treatment|Use of selective cyclooxygenase-2 (COX-2) inhibitors (Arcoxia® and Celebrex®) as assessed by the Investigating Physician at time of treatment discontinuation was correlated to the overall duration of treatment experienced by the participant (i.e., intermittent or continuous selective COX-2 inhibitor use vs. total participant time on treatment). Type of use was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days). Four successive treatment intervals were assessed in this endpoint: 1) Up to thirty days of treatment 2) From one to three months of treatment 3) From three months to one year of treatment and 4) More than one year of treatment.|Up to 12 months|All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.|||Participants|||Number
2661206|NCT01572675|Primary|Type of Arcoxia® and Celebrex® Use|The type of Arcoxia® or Celebrex® use during the study was classified as continuous (without interruption >7 days) or intermittent (with interruption >7 days) by the Investigating Physician at time of treatment discontinuation.|Up to 12 months|All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.|||Participants|||Number
2661207|NCT01572675|Primary|Reasons for Discontinuation of Treatment With Arcoxia® and Celebrex®|The individual reasons for discontinuation of treatment with Arcoxia® or Celebrex® were identified over the course of study through either physician selection from a pre-determined list or verbatim entry by the physician with subsequent re-codification by Sponsor.|Up to 12 months|All participants who discontinued treatment during follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.|||Participants|||Number
2661208|NCT01572675|Primary|Maximum Dosage Prescribed During Treatment With Arcoxia® and Celebrex®|Mean maximum dosage prescribed during follow-up in participants treated with Arcoxia® or Celebrex®. Dosage is expressed as total daily dose.|Up to 12 months|All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.|||mg/day||Standard Deviation|Mean
2661209|NCT01572675|Primary|Total Duration of Treatment With Arcoxia® and Celebrex®|The total duration of treatment (DoT) with Arcoxia® or Celebrex® was determined for populations that achieved end-of study and end-of-protocol or that were categorized as lost to follow-up. Participants enumerated as end-of-study had their treatment discontinued during the protocol-specified one year of follow-up. Participants enumerated as end-of-protocol were ongoing treatment at end of the protocol-specified one year of follow-up. Participants categorized as lost to follow-up had no follow-up visit where a determination of discontinuation from treatment could be made.|Up to 12 months|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (duration of prescription)|||Days||Standard Deviation|Mean
2661465|NCT01569815|Primary|Elimination Half-life (t1/2) After Multiple Dose (Day 5) Administration|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 5|FAS|||hr||Standard Deviation|Mean
2661211|NCT01572675|Primary|Number of Participants Requiring Dose Modification of Arcoxia® and Celebrex®|Participants requiring modifications to their Arcoxia® or Celebrex® dose regimens during their on study treatment course were identified. Dose modifications were defined as an increase, decrease followed by increase, decrease, or increase followed by decrease in the participant's daily dose; all categorizations were exclusive. If the maximum dose at discontinuation of treatment was greater than that at initiation, the participant was considered as having had an increase in dose during treatment. Alternatively, if data obtained from a participant's prescription records showed a successive lowering of dosage, the participant was considered as having had a decrease in dose during treatment. Dosages at baseline were included in the dose modification determination for treatment renewal participants.|Up to 12 months|All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.|||Participants|||Number
2661212|NCT01572675|Primary|Mean Dosage of Arcoxia® and Celebrex® During Treatment|The mean dosage of Arcoxia® and Celebrex® during treatment was determined. For participants who stopped treatment after their initial study visit, the maximum dose recorded at their final study visit was considered when calculating their mean dosage during treatment.|Up to 12 months|All participants who discontinued treatment during follow-up or were still on treatment after one year of follow-up under protocol; participants who were lost to follow-up were excluded from this analysis.|||mg/day||Standard Deviation|Mean
2661213|NCT01572675|Primary|Dosage of Arcoxia® and Celebrex® at Initiation|Dosage at initiation of treatment with Arcoxia® or Celebrex® was identified. MA compliant dosage at initiation corresponds to a (starting) dose of 30 mg daily for Arcoxia® or a (starting) dose of 200 mg daily for Celebrex®. The dose for initiation was calculated by multiplying the number of doses per day with the dose level (total daily dose) as noted in the prescription record.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (dosage at initiation)|||Participants|||Number
2661214|NCT01572675|Primary|Indications for Which Arcoxia® and Celebrex® Were Prescribed|The reasons (indications) for prescribing of Arcoxia® or Celebrex® were collected in open-field forms by the Investigator; category assignment (i.e, re-codification) of verbatim entries was conducted by a group of medical experts under the guidance approved by the MA. This endpoint gives the number of participants treated per indication.|At study entry|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (indication)|||Participants|||Number
2661215|NCT01572675|Primary|Reasons for Misuse of Arcoxia® and Celebrex®|Proper use of study medication is defined as administration of medication in terms of indication and dosage according to MA. Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.|Up to 12 months|The per protocol analysis population consisting of all participants in compliance with study inclusion criteria with data of sufficient quality for analysis of the endpoint (misuse)|||Participants|||Number
2661216|NCT01572675|Primary|Number of Participants Demonstrating Proper Use of Arcoxia® and Celebrex®|Proper use of study medication is defined as administration of medication in terms of indication and dosage according to Market Authorization (MA). Proper use of Arcoxia® is defined as administration of a starting dose of 30 mg daily, not to exceed 60 mg daily during follow-up, for the treatment of symptoms of osteoarthritis. Proper use of Celebrex® is defined as administration of a starting dose of 200 mg daily, not to exceed 400 mg daily during follow-up, for easing symptoms in the treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Data to assess proper use were collected through use of a medical questionnaire and patient form. Data pertaining to indication was collected by open-field to allow physicians to precisely indicate the reason for prescription. Recorded indications were then analyzed by two medical experts (an independent expert and a member of the Scientific Community) to assess proper use or misuse.|Up to 12 months|All participants with complete data relative to correct use of the coxib and at least 1 data point relative to misuse of the coxib.|||Participants|||Number
2661217|NCT01572428|Secondary|Patients With 1 or More Conventional Adenomas|Patient had to have at least 1 polyp that was an adenoma.|During the colonoscopy procedure||||Participants|||Count of Participants
2661218|NCT01572428|Secondary|Number of Conventional Adenomas Per Patient in Entire Colon|Average number of adenomas (located anywhere throughout the colon) found per patient.|During the colonoscopy procedure||||Adenomas per patient||Standard Deviation|Mean
2661219|NCT01572428|Secondary|Total Number of Conventional Adenomas in Entire Colon|Total quantity of adenomas found during colonoscopy procedure.|During the colonoscopy procedure||||Conventional Adenomas|||Number
2661220|NCT01572428|Secondary|Patients With 1 or More Serrated Lesions Proximal to the Sigmoid Colon|Patient had to have at least 1 polyp that had serrated histology and was located proximal to the sigmoid colon (cecum to transverse colon).|During the colonoscopy procedure||||Participants|||Count of Participants
2661221|NCT01572428|Primary|Number of Serrated Lesions Proximal to the Sigmoid Colon Per Patient|Average number of polyps per patient that had serrated histology and were located proximal to the sigmoid colon (cecum to transverse colon).|During the colonoscopy procedure||||Number of serrated lesions||Standard Deviation|Mean
2661222|NCT01572428|Primary|Total Number of Serrated Lesions Proximal to the Sigmoid Colon|Total quantity of serrated lesions found proximal to the sigmoid colon during colonoscopy.|During the colonoscopy procedure||||Serrated Lesions|||Number
2661466|NCT01569815|Primary|Area Under the Concentration-time Curve (AUC0-24) From Time Zero to 24- Hour Post-dose (Day 1), and After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 1 and day 5|FAS|||ng*hr/mL||Standard Deviation|Mean
2661223|NCT01572389|Primary|Change in Patient Health Questionnaires-9 During Intervention|"The Patient Health Questionnaires-9 assesses depressive symptoms during the course of the intervention. The PHQ-9 ranges in score from 0 - 27; where higher numbers represent increase levels of depression. Scores from 5 - 9 represent minimal symptoms of depression; 10 - 14 represent minor depression, dysthymia, or major depression - mild; 15 - 19 represent major depression, moderately severe; and scores of 20 and above is considered major depression, severe. Participants with that scored a 10 or above were eligible for the study."|PHQ-9 will be assessed at baseline, 6-, and 12- months.|The number analyzed at each timepoint decreased due to non-completion of the assessment by participants.|||units on a scale||Standard Deviation|Mean
2661224|NCT01572389|Primary|Change in Hemoglobin A1C|Measures of Hemoglobin A1C will be taken to assess average blood glucose levels throughout the study as an indicator of diabetes control. Hemoglobin A1C is a blood test taken to assess average blood glucose levels in the body. Normal range of A1C level is below 5.7. Eligible participants had an A1C of 7.5 or higher. The higher the A1C the more a person's diabetes is uncontrolled.|Hemoglobin A1C levels will be measured at baseline, 6-, and 12- months.|The number analyzed at each timepoint decreased due to non-completion of the A1C blood draw by participants.|||percentage of glycated hemoglobin||Standard Deviation|Mean
2661225|NCT01572298|Secondary|Percentage of New Bone Formation (Histologic)||5 months after surgery|No data were collected for this outcome||||||
2661226|NCT01572298|Primary|Gain in Horizontal Ridge Dimension||5 months after surgery||||gain in ridge width (mm)||Standard Deviation|Mean
2661227|NCT01572207|Secondary|Changes From Baseline in Quality of Life|The Multiple Sclerosis Impact Scale will be administered. The total score is a sum of individual question scores, ranging from 29 (best possible outcome) to 145 (worst possible outcome). Therefore, the lower the number, the better the outcome.|Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).||||scores on a scale||Full Range|Mean
2661228|NCT01572207|Secondary|Changes From Baseline in Physical Fitness|The physical assessment will include measuring the 6-minute walk test. The units reported are in meters for distance traveled by each participant during the six minutes. For this scale, the higher number is the better score as it is a direct measure of distance traveled.|Each patient will be given the assessment at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).||||meters||Full Range|Mean
2661229|NCT01572207|Primary|Changes From Baseline in Physical Activity Behavior|"Physical activity behavior will be measured with the Godin Leisure-Time Exercise Questionnaire. The Godin Leisure-Time Exercise Questionnaire calculates total weekly leisure activity by summing the products of separate intensities. Weekly leisure activity score = (9 x time/week) + (5 x times/week) + (3 x times/week) for strenuous, moderate and light activities, respectively. The scale is summed to equal the Total Units Mean.~With this scale, higher numbers are considered to be the better outcome as it indicates more physical activity."|Each subject will be given the questionnaire at 3 points during the study, at baseline, interim test (an average of 12 weeks from baseline) and at posttest (an average of 24 weeks from baseline).||||scores on a scale||Full Range|Mean
2661230|NCT01571557|Secondary|Mean Change From Baseline in Central Retinal Thickness|Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening.|Baseline, Week 24|All enrolled patients with complete data at this time point|||micrometers (μm)||Standard Deviation|Mean
2661231|NCT01571557|Secondary|Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye|"BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are approximate ETDRS letters to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 3 letters or more indicates an improvement in BCVA."|Baseline, 48 Weeks|All enrolled patients|||Percentage of Patients|||Number
2661232|NCT01571557|Secondary|Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye|"BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are approximate ETDRS letters to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 2 letters or more indicates an improvement in BCVA."|Baseline, 48 Weeks|All enrolled patients|||Percentage of Patients|||Number
2661233|NCT01571557|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|"BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are approximate ETDRS letters to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number change from baseline in the number of letters read means vision has improved and a negative number change from baseline means vision has worsened."|Baseline, Week 12|All enrolled patients with complete data at this time point|||Approximate EDTRS Letters||Standard Deviation|Mean
2661234|NCT01571453|Secondary|Number of Adverse Events||Baseline to Week 12|||||||
2661237|NCT01571453|Secondary|Change in HAM-A Total Score From Baseline to Week 8|Hamilton Anxiety Rating Scale (HAM-A) is a 14-item rating scale designed to assess the global anxiety. Each symptom is rated from 0 (absent) to 4 (maximum severity). The total score of the 14 items ranges from 0 to 56. Higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.|||units on a scale||Standard Error|Mean
2661238|NCT01571453|Secondary|CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not. Higher score = more affected.|Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.|||units on a scale||Standard Error|Mean
2661239|NCT01571453|Secondary|Change in CGI-S Score From Baseline to Week 8|Clinical Global Impression Scale - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.|||units on a scale||Standard Error|Mean
2661240|NCT01571453|Primary|Change From Baseline in MADRS Total Score at Week 8|Montgomery and Asberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|The full-analysis set (FAS) comprises all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the MADRS total score.|||units on a scale||Standard Error|Mean
2661241|NCT01571427|Primary|Changes in CAMCI Total Score (Post-study Test Score - Baseline Test Score)|"Computer Assessment of Mild Cognitive Assessment (CAMCI) is a battery of computerized tasks to assess cognitive performance, developed by the Psychology Software Tools. The software provides standardized score (z-score) based on subject's age, sex and education.* The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Higher Z-score means better cognitive function. A positive change in Z-scores here indicates a favorable outcome. Total score (global cognitive function measure) is used here. Pre-post trial changes in test results among the experimental group are compared with pre-post changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM)~*: Saxton J, Morrow L, Eschman A, Archer G, Luther J, Zuccolotto A. Computer assessment of mild cognitive impairment. Postgrad Med. 2009;121(2):177-85."|6 weeks (primary endpoint) from baseline|Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.|||z-score (standardized score)||Standard Error|Mean
2661242|NCT01571427|Primary|Changes in Cogstate Two Back Accuracy (Post-study Test Score - Baseline Test Score)|"In this test, the on-screen instructions ask: Is the card the same as that shown two cards ago?. A playing card is presented face up in the center of the screen. The participant must decide whether the card is the same as the card shown two cards previously. If the card is the same the participant should press Yes, and if it is not the same the participant should press No. The participant is encouraged to work as quickly as they can and be as accurate as possible. Accuracy of performance (arcsine transformation of the square root of the proportion of correct responses) is reported here. Pre-post trial changes in test results among the experimental group will be compared with pre-post changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM)"|6 weeks (primary endpoint) from baseline|Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.|||arcsine transformed values (see above)||Standard Error|Mean
2661243|NCT01571427|Primary|Changes in Cogstate One Back Accuracy (Post-study Test Score - Baseline Test Score)|"In this test, the on-screen instructions ask: Is the previous card the same?. A playing card is presented face up in the center of the screen. The participant must decide whether the card is the same as the previous card. If the card is the same the participant should press Yes, and if it is not the same the participant should press No. The participant is encouraged to work as quickly as they can and be as accurate as possible. Accuracy of performance (arcsine transformation of the square root of the proportion of correct responses) is reported here. Pre-post trial changes in test results among the experimental group will be compared with pre-post changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM). Larger changes mean the score improved at the post trial assessment."|6 weeks (primary endpoint) from baseline|Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.|||arcsine transformed values (see above)||Standard Error|Mean
2661268|NCT01571362|Secondary|Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire|Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?|Screening, Weeks 4, 8, and 12|ITT Population; the denominator for the percentage calculation is the number of participants who had both Screening value and Post Screening value for each treatment and visit. Imputation using the LOCF method.|||Percentage of participants|||Number
2661244|NCT01571427|Primary|Changes in Cogstate Computerized Test: Detection Test (Post-study Test Score - Baseline Test Score)|"In detection test, the on-screen instructions ask: Has the card turned over?. A playing card is presented face down in the center of the screen. The card flips over so it is face up. As soon as the card flips over the participant must press Yes. The participant is encouraged to work as quickly as they can and be as accurate as possible.Speed of performance (mean of the log10 transformed reaction times for correct responses) is used here. Pre-post trial changes in test results among the experimental group were compared with pre-post changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM). Larger changes mean subjects got slower in reaction at the post-trial assessment. Negative changes indicates subjects got faster in reaction at the post-trial assessment."|6 weeks (primary endpoint) from baseline|Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.|||log 10 milliseconds||Standard Error|Mean
2661245|NCT01571427|Primary|Changes in the Stroop Color and Word Test (Stroop Test C) Scores (Post-study Test Scores - Baseline Test Scores)|"In the Stroop test, subjects are required to read three different pages of stimuli in a designated time as quickly as possible. First, the individual is asked to name a series of colored squares (Color Naming task, Stroop Test A). Second, the individual is asked to read color words (Word Reading task, Stroop Test B). The final task is the Color-Word Naming task (Stroop Test C) on which the individual is shown the names of colors printed in conflicting ink colors (e.g., the word red in blue ink) and is asked to name the color of the ink rather than the word. Each test (A, B, C) is administered for 45 seconds. The number of words correctly named for the Stroop Test C was used here. The maximum score of this test is 100 (range: 0 - 100). The higher score indicates better functions. The changes (post-study - baseline test scores) among the experimental group are compared with those among the control group. The higher change scores mean improved function."|6 weeks (primary endpoint) from baseline|Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.|||Number of words correctly named||Standard Deviation|Mean
2661246|NCT01571427|Primary|Changes in Trail Making Test B Scores (Post-study Test Score - Baseline Test Score)|In Trail Making test B, the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy within 300 seconds. In Test B, the circles include both numbers (1 - 13) and letters (A - L). Time to complete is used here. Pre-post trial changes in test results among the experimental group are compared with pre-post changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM). Larger changes mean subjects got slower to complete the test at the post-trial assessment. Negative changes indicates subjects completed the test faster at the post-trial assessment.|6 weeks (primary endpoint) from baseline|Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.|||Seconds||Standard Deviation|Mean
2661247|NCT01571427|Primary|Changes in Trail Making Test A Scores (Post-study Test Score - Baseline Test Score)|In Trail Making test A, the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy within 150 seconds. Time to complete is used here. Pre-post trial changes in test results among the experimental group are compared with pre-post changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM). Larger changes mean subjects got slower to complete the test at the post-trial assessment. Negative changes indicates subjects completed the test faster at the post-trial assessment.|6 weeks (primary endpoint) from baseline|Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.|||Seconds||Standard Deviation|Mean
2661248|NCT01571427|Primary|Changes in the Consortium to Establish a Registry for Alzheimer's Disease Word List Delayed Recall (Post-study Test Score - Baseline Test Score)|Consortium to Establish a Registry for Alzheimer's Disease Word List Delayed Recall (CERAD Word List Delayed Recall) total score counts number of words correctly recalled in one trial (10 words) and it ranges from 0 to 10. Pre-post trial changes in test results among the experimental group was compared with pre-post changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM)|6 weeks (primary endpoint) from baseline|Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.|||Number of words||Standard Deviation|Mean
2661249|NCT01571427|Primary|Changes in the Consortium to Establish a Registry for Alzheimer's Disease Word List Immediate Recall (Post-study Test Score - Baseline Test Score)|Consortium to Establish a Registry for Alzheimer's Disease Word List Immediate Recall (CERAD Word List Immediate Recall) total score counts number of words correctly recalled over 3 trials (with each trial having 10 words), and ranges from 0 to 30. Pre-post changes in test results among the experimental group were compared with pre-post changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM)|6 weeks (primary endpoint) from baseline|Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.|||Number of words||Standard Deviation|Mean
2661250|NCT01571427|Primary|Changes in Verbal Fluency Letter Test Scores (Post-study Test Score - Baseline Test Score)|Verbal fluency letter test is a neuropsychological test. In the test, participants have to produce as many words as possible which start with a letter F, A and S (3 separate test for each letter) within 60 seconds. Each test score ranges from 0 to 40. Total of 3 tests scores (F, A and S) ranges from 0 to 120. Changes in test results among the experimental group are compared with changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM) Higher values mean decline is less or test scores improved at post-study assessment.|6 weeks (primary endpoint) from baseline|Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.|||Number of words||Standard Deviation|Mean
2661251|NCT01571427|Primary|Changes in Category Fluency (Animals) Test Scores (Post-study Test Score - Baseline Test Score)|Verbal fluency Animals test is a neuropsychological test. In the test, participants have to produce as many words as possible from a category of animals within 60 seconds. Total score ranges from 0 to 70. Changes in test results among the experimental group are compared with changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM). Higher values mean decline is less or score improve at post-study assessment.|6 weeks (primary endpoint) from baseline|Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.|||Number of words||Standard Deviation|Mean
2661252|NCT01571427|Primary|Changes in Global Cognitive Function Using Mini Mental State Examination Score (Post-study Test Score - Baseline Test Score)|Mini Mental State Examination assess global cognitive function. Possible score ranges from 0 to 30. In this study, score ranges from 24 to 30 (those with MMSE <24 at baseline were excluded according to the study exclusion criteria). Changes in test results among the experimental group are compared with changes among the control group using linear regression models. (no drop out reported and therefore no need to use mixed effects models or MMRM) Higher values (post-pre) indicate that decline was less or test score improved more.|6 weeks (primary endpoint) from baseline|Sampling frame consists of retirement communities and Layton Aging Alzheimer's Disease research center volunteer lists. The survey asking whether they would like to participate in the study was distributed among 2000 subjects.|||score on a scale||Standard Deviation|Mean
2661253|NCT01571362|Secondary|Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period|Observed steady-state plasma concentration (Cobs) of naltrexone and 6-β-naltrexol|Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12|Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||pg/mL||Standard Deviation|Mean
2661254|NCT01571362|Secondary|Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period|Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone|Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12|Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||ng/mL||Standard Deviation|Mean
2661255|NCT01571362|Secondary|Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period|Cobs of naltrexone and 6-β-naltrexol|Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline|Titration Period Safety Population; participants assessed at Week 6 had not been randomized to the Double-Blind Period; participants assessed at Randomization Baseline had been randomized to the Double-Blind Period.|||pg/mL||Standard Deviation|Mean
2661256|NCT01571362|Secondary|Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period|Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone.|Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline|Titration Period Safety Population; participants assessed at Week 6 had not been randomized to the Double-Blind Period; participants assessed at Randomization Baseline had been randomized to the Double-Blind Period.|||ng/mL||Standard Deviation|Mean
2661257|NCT01571362|Secondary|Median Oxycodone Duration of Treatment During the Double-Blind Treatment Period||Double-Blind Period|Double-Blind Safety Population|||days||Inter-Quartile Range|Median
2661258|NCT01571362|Secondary|Median Oxycodone Average Daily Dose During the Double-Blind Treatment Period||Double-Blind Period|Double-Blind Safety Population|||mg||Inter-Quartile Range|Median
2661259|NCT01571362|Secondary|Mean Oxycodone Duration of Treatment During the Double-Blind Treatment Period||Double-Blind Period|Double-Blind Safety Population|||days||Standard Deviation|Mean
2661260|NCT01571362|Secondary|Mean Oxycodone Average Daily Dose During the Double-Blind Treatment Period||Double-Blind Period|Double-Blind Safety Population|||mg||Standard Deviation|Mean
2661261|NCT01571362|Secondary|Median Oxycodone Duration of Titration During the Open-Label Titration Period||Open-Label Period|Titration Period Safety Population|||days||Inter-Quartile Range|Median
2661262|NCT01571362|Secondary|Median Oxycodone Average Daily Dose During the Open-Label Titration Period||Open-Label Period|Titration Period Safety Population|||mg||Inter-Quartile Range|Median
2661263|NCT01571362|Secondary|Mean Oxycodone Duration of Titration During the Open-Label Titration Period||Open-Label Period|Titration Period Safety Population|||days||Standard Deviation|Mean
2661264|NCT01571362|Secondary|Mean Oxycodone Average Daily Dose During the Open-Label Titration Period||Open-Label Period|Titration Period Safety Population|||mg||Standard Deviation|Mean
2661265|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain|Question 3b: nights stayed in the hospital|Screening, Weeks 4, 8, and 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Number of nights||Standard Deviation|Mean
2661266|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain|Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain|Screening, Weeks 4, 8, and 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Dollars||Standard Deviation|Mean
2661267|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain|Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain|Screening, Weeks 4, 8, and 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Number of visits||Standard Deviation|Mean
2661467|NCT01569815|Primary|Maximum Peak Plasma Concentration (Cmax) Observed After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 1, day 5||||ng/mL||Standard Deviation|Mean
2661270|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments|Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain.|Randomization Baseline, Weeks 4, 8, and 12|ITT Population, imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Dollars||Standard Deviation|Mean
2661271|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain|Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain|Randomization Baseline, Weeks 4, 8, and 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Number of visits||Standard Deviation|Mean
2661272|NCT01571362|Secondary|Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire|Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?|Randomization Baseline, Weeks 4, 8, and 12 (or Early Termination)|ITT Population; the denominator for the percentage calculation is the number of participants who had both Randomization Baseline value and Post Randomization value for each treatment and visit. Imputation using the LOCF method.|||Percentage of participants|||Number
2661273|NCT01571362|Secondary|Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital|Question 3b: nights stayed in the hospital, if answer to Q3a was yes.|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Number of days||Standard Deviation|Mean
2661274|NCT01571362|Secondary|Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks|Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Dollars||Standard Deviation|Mean
2661275|NCT01571362|Secondary|Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain|Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Number of visits||Standard Deviation|Mean
2661276|NCT01571362|Secondary|Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital|Question 3b: nights stayed in the hospital, if answer to Q3a was yes.|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Number of days||Standard Deviation|Mean
2661277|NCT01571362|Secondary|Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks|Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Dollars||Standard Deviation|Mean
2661278|NCT01571362|Secondary|Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain|Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain.|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Number of visits||Standard Deviation|Mean
2661279|NCT01571362|Secondary|Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire|Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?|Screening, Randomization Baseline|ITT Population; the denominator for the percentage calculation is the number of participants who had both Screening value and Randomization Baseline value.|||Percentage of participants|||Number
2661280|NCT01571362|Secondary|Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire|Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain?|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; the denominator for the percentage calculation is the number of participants who had both Screening value and End of Open-Label value.|||Percentage of participants|||Number
2661281|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Screening, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Error|Least Squares Mean
2661297|NCT01571362|Secondary|Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS|The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Deviation|Mean
2661282|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Screening, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Error|Least Squares Mean
2661283|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Screening, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Error|Least Squares Mean
2661284|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Screening, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Error|Least Squares Mean
2661285|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Randomization Baseline, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Error|Least Squares Mean
2661286|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism).~Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Randomization Baseline, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Error|Least Squares Mean
2661287|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5).~Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Randomization Baseline, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Error|Least Squares Mean
2661288|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~% work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4).~Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Randomization Baseline, Weeks 4, 8, and 12|ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Error|Least Squares Mean
2661335|NCT01571362|Secondary|Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain right now at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
2661289|NCT01571362|Secondary|Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.~work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4).~impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5).~overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism).~activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6).~Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Deviation|Mean
2661290|NCT01571362|Secondary|Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain|"A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment /absenteeism+presenteeism); and activity impairment.~work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4).~impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5).~overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism).~activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity."|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage||Standard Deviation|Mean
2661291|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D VAS|The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.|Screening, Week 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2661292|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index|Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|Screening, Week 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2661293|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using the EQ-5D VAS|The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.|Randomization Baseline, Week 12|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2661294|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index|Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health|Randomization Baseline, Week 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2661295|NCT01571362|Secondary|Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS|The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion.|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Deviation|Mean
2661296|NCT01571362|Secondary|Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index|Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Deviation|Mean
2661298|NCT01571362|Secondary|Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index|The EQ 5D Health Questionnaire is a self completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Deviation|Mean
2661299|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey|SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.|Screening, Week 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2661300|NCT01571362|Secondary|Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey|SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.|Randomization Baseline, Week 12|ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Error|Least Squares Mean
2661301|NCT01571362|Secondary|Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score|SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state.|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Deviation|Mean
2661302|NCT01571362|Secondary|Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score|SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher scores indicates a better health state.|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Score on a scale||Standard Deviation|Mean
2661303|NCT01571362|Secondary|Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period|Participants used an electronic tablet at the center to rate their overall treatment satisfaction with study drug during study participation using a 5-point categorical scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied).|Week 12 or Early Termination|ITT Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage of participants|||Number
2661304|NCT01571362|Secondary|Satisfaction With Treatment at Randomization Baseline|Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied.|Randomization Baseline|ITT Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage of participants|||Number
2661305|NCT01571362|Secondary|Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants|Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied.|End of Open-Label Titration Period (Week 4, 5, or 6 or Early Termination)|Titration Period Safety Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage of participants|||Number
2661306|NCT01571362|Secondary|Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor|Represents the score at Randomization Baseline / score at Week 8 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.|Randomization Baseline, Week 8|ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Week 8 for each treatment.|||Percentage of participants|||Number
2661307|NCT01571362|Secondary|Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor|Represents the score at Randomization Baseline / score at Week 4 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.|Randomization Baseline, Week 4|ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Week 4 for each treatment.|||Percentage of participants|||Number
2661308|NCT01571362|Secondary|Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor|Represents the score at Screening / score at to end of the titration period in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.|Screening, Randomization Baseline, or Early Termination|Titration Period Safety Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Screening.|||Percentage of participants|||Number
2661309|NCT01571362|Secondary|Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor|Represents the score at Screening / score at Randomization Baseline in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities.|Screening, Randomization Baseline|ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Screening.|||Percentage of participants|||Number
2661310|NCT01571362|Secondary|Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score|RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.|Randomization Baseline, Weeks 2, 4, and 8|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Error|Least Squares Mean
2661311|NCT01571362|Secondary|Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score|RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.|Screening, Weeks 2, 4, 8, and 12|ITT Population; imputation using the LOCF method for Week 12 only; Weeks 2, 4, 8 included observed cases. n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Error|Least Squares Mean
2661312|NCT01571362|Secondary|Change From Screening Period to Randomization Baseline in RMDQ Total Score|RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function.|Screening, Randomization Baseline|ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Deviation|Mean
2661313|NCT01571362|Secondary|Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants|RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher scores indicating greater disability.|Screening, Week 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Deviation|Mean
2661314|NCT01571362|Secondary|SOWS Total Score During the Post-Treatment Period|The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.|Follow-Up Weeks 1 and 2|Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Deviation|Mean
2661315|NCT01571362|Secondary|SOWS Total Score During the Double-Blind Treatment Period|The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.|Randomization Baseline, Weeks 1, 2, 4, 8, and 12|Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Deviation|Mean
2661468|NCT01569815|Primary|Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 1 and day 5||||hr||Full Range|Median
2661316|NCT01571362|Secondary|Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period|The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome.|Screening, Weeks 1, 2, 3, 4, 5, and 6|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Deviation|Mean
2661317|NCT01571362|Secondary|Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category|The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.|Follow-Up Weeks 1 and 2|Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage of participants|||Number
2661318|NCT01571362|Secondary|Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category|The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.|Randomization Baseline, Weeks 1, 2, 4, 8, 12 (or Early Termination)|Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage of participants|||Number
2661319|NCT01571362|Secondary|Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category|The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.|Screening, Weeks 1, 2, 3, 4, 5, 6 (or Early Termination)|Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint.|||Percentage of participants|||Number
2661320|NCT01571362|Secondary|COWS Total Score During the Post-Treatment Period|The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.|Follow-Up (FU) Weeks 1 and 2|Double-Blind Safety Population. Only participants with values at both Randomization Baseline and each respective visit were included in the change from Randomization Baseline analysis; n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Deviation|Mean
2661321|NCT01571362|Secondary|COWS Total Score During the Double-Blind Treatment Period|The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.|Randomization Baseline, Weeks 1, 2, 4, 8, and 12|Double-Blind Safety Population. Only participants with values at both Randomization Baseline and each respective visit were included in the change from Randomization Baseline analysis; n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Deviation|Mean
2661322|NCT01571362|Secondary|Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period|The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal.|Screening, Weeks 1, 2, 3, 4, 5, and 6|Titration Period Safety Population. Only participants with values at both Screening and each respective visit were included in the change from screening analysis; n=number of participants analyzed for the given parameter at the specified timepoint.|||Units on a scale||Standard Deviation|Mean
2661323|NCT01571362|Secondary|Median Time to Treatment Discontinuation for Investigator-Reported Lack of Efficacy During the Double-Blind Treatment Period|If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason. The survival duration begins on the date of first dose in the Double-Blind period and is calculated as the [date of event or discontinuation - date of first dose in Double-Blind Period +1].|Week 1 up to Week 12|ITT Population; an event was defined as a participant with treatment discontinuation for investigator-reported lack of efficacy.|||days||95% Confidence Interval|Median
2661324|NCT01571362|Secondary|Percentage of Participants Discontinuing Treatment for Investigator-Reported Lack of Efficacy|If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason.|Week 1 up to Week 12|ITT Population; an event was defined as a participant with treatment discontinuation for investigator-reported lack of efficacy.|||Percentage of participants|||Number
2661336|NCT01571362|Secondary|Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for average pain at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
2661469|NCT01569763|Post-Hoc|Subjects With Amenorrhea at 12 Months|Amenorrhea at 12 Months- Number of Subjects experiencing no menstrual bleeding|12 Months|Randomized subjects|||participants|||Number
2661325|NCT01571362|Secondary|Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period|The percentage of lost analgesic response was defined as: (rolling seven day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the [date of event or last diary pain score - date of first dose in Double-Blind Treatment +1].|Randomization Baseline, up to Week 12|ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% loss of analgesic response from Randomization Baseline.|||days||95% Confidence Interval|Median
2661326|NCT01571362|Secondary|Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period|The percentage of lost analgesic response is defined as: (rolling 7-day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the [date of event or last diary pain score - date of first dose in Double-Blind Treatment +1].|Randomization Baseline, up to Week 12|ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% loss of analgesic response from Randomization Baseline.|||Percentage of participants|||Number
2661327|NCT01571362|Secondary|Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline|The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the [date of event or last diary pain score - date of first dose in Titration Period +1].|Screening, Randomization Baseline (up to 6 weeks)|ITT Population; an event was defined as a participant with 20%, 30%, 40% or 50% analgesic response from Screening.|||days||95% Confidence Interval|Median
2661328|NCT01571362|Secondary|Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline|The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100.|Screening, Randomization Baseline (up to 6 weeks)|ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening.|||Percentage of participants|||Number
2661329|NCT01571362|Secondary|Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment|The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period minus (-) Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. An event was defined as a participant with 20, 30, 40, or 50% analgesic response from Screening. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the [date of event or last diary pain score - date of first dose in Titration Period +1].|Screening, Week 4, 5, or 6|Titration Period Safety Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening.|||days||95% Confidence Interval|Median
2661330|NCT01571362|Secondary|Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment|The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times100.|Screening, Week 4, 5 or 6|Titration Period Safety Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening.|||Percentage of participants|||Number
2661331|NCT01571362|Secondary|Average Daily Use of Rescue Acetaminophen (Milligrams Per Day [mg/Day]) During the Double-Blind Treatment Period|The amount of acetaminophen administered for each treatment during the Double-Blind Treatment Period. Average daily use calculated as: total dose of rescue medication during Double-Blind Period divided by the number of days in Double-Blind Period.|Daily from Day 1 of the Double-Blind Period through Week 12|ITT Population|||Average mg/day||Standard Error|Least Squares Mean
2661332|NCT01571362|Secondary|Area Under the Curve (AUC) of eDiary NRS-Pain Scores From Randomization Baseline to Final 2 Weeks of the Double-Blind Treatment Period (Weeks 11 and 12)|NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). AUC was calculated using daily change from Baseline scores from Baseline until the last dose date in the Double-Blind Treatment Period. AUC was calculated for each participant using the linear trapezoidal method. Higher scores indicate greater pain.|Randomization Baseline, Weeks 11 and 12|ITT Population; linear interpolation was used for internal missing values, with addition of 0 to the AUC for missing values from early discontinuation.|||Change in units on a scale*days||Standard Error|Least Squares Mean
2661333|NCT01571362|Secondary|Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index|Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain interference index at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
2661334|NCT01571362|Secondary|Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index|Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain severity index at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
2661338|NCT01571362|Secondary|Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.|Weeks 2, 4, 8 and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for worst pain at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
2661339|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index|Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain interference index at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
2661340|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index|Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain severity index at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
2661341|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain right now at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
2661342|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for average pain at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
2661343|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation by LOCF; n=number of participants assessed for least pain at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
2661344|NCT01571362|Secondary|Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain.|Weeks 2, 4, 8, and 12|ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for worst pain at the specified timepoint.|||Units on a Scale||Standard Error|Least Squares Mean
2661345|NCT01571362|Secondary|Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index|BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.|Screening, Randomization Baseline|ITT Population - observed cases; n=number of participants assessed for the given parameter at the specified timepoint.|||units on scale||Standard Deviation|Mean
2661346|NCT01571362|Secondary|Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index|BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes.|Screening, Week 4, 5, or 6|Titration Period Safety Population: defined as all participants who received any amount of ALO-02 capsules during the Open-Label Conversion and Titration Period; imputation using the LOCF method. n=number of participants contributing to the mean for the specified parameter.|||Units on a Scale||Standard Deviation|Mean
2661347|NCT01571362|Secondary|Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥50%|Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.|Weeks 11 and 12|ITT Population|||percentage of participants|||Number
2661348|NCT01571362|Secondary|Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥40%|Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.|Weeks 11 and 12|ITT Population|||percentage of participants|||Number
2661349|NCT01571362|Secondary|Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥30%|Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain.|Weeks 11 and 12|ITT Population|||percentage of participants|||Number
2661350|NCT01571362|Secondary|Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction of Greater or Equal to (≥) 20%|Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 equals (=) no pain to 10 = worst possible pain. Higher scores indicate greater pain.|Weeks 11 and 12|ITT Population|||percentage of participants|||Number
2661351|NCT01571362|Secondary|Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit).|Measure represents the score at Randomization Baseline / score at Week 12 (or Early Termination) in PGA, a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor).|Randomization Baseline, Week 12|ITT Population; percentage based on the number of participants who had non-missing values at Randomization Baseline and Week 12/early termination for each treatment. Imputation using LOCF method.|||Percentage of participants|||Number
2661352|NCT01571362|Secondary|Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit).|The RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain. An individual participant's score can vary from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher score indicating greater disability.|Week 12|ITT Population; imputation using last observation carried forward (LOCF) method.|||Units on a Scale||Standard Error|Least Squares Mean
2661353|NCT01571362|Primary|Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12)|Weekly average diary NRS-Pain scores were derived from the daily NRS-pain scale and calculated as the mean of the last 7 days. NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.|Weeks 11 and 12|Intent-to-Treat (ITT) Population: all participants who were randomized into the Double-Blind Treatment Period and received at least 1 dose of study drug after randomization; the averaged value for each participant from the 100 imputed datasets were used. Hybrid multiple and single imputation were applied, depending on reason for discontinuation.|||Units on a Scale||Standard Error|Least Squares Mean
2661354|NCT01571284|Secondary|Change From Baseline in HRQL EQ-5D-3L VAS Score|EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and VAS. EQ-5D descriptive system comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on 3 levels (no problem, some problems & severe problems) within a particular EQ-5D dimension. 5 dimensional 3-level system was converted into single index utility score. The VAS recorded the respondent's self-rated health on a vertical visual analogue scale. The VAS 'thermometer' has endpoints of 100 (Best imaginable health state) at the top and 0 (Worst imaginable health state) at the bottom. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.|Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at EOT (within 30 days of last treatment) (maximum exposure: 214 weeks)|EQ-5D analysis population. Here, 'Number Analyzed' = participants analyzed at specified timepoints.|||units on a scale||Standard Deviation|Mean
2661355|NCT01571284|Secondary|Change From Baseline in HRQL EQ-5D-3L Quality of Life: Single Index Utility Score|EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D descriptive system comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on 3 levels (no problem, some problems & severe problems) within a particular EQ-5D dimension. 5 dimensional 3-level system was converted into single index utility score. Possible values for single index utility score ranged from -0.594 (severe problems in all dimensions) to 1.0 (no problem in all dimensions) on scale where 1 represented best possible health state.|Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at EOT (within 30 days of last treatment) (maximum exposure: 214 weeks)|EQ-5D analysis population: participants who signed informed consent form, had an evaluable EQ-5D questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment (either Aflibercept or FOLFIRI). Here, 'Number Analyzed' = participants analyzed at specified timepoints.|||units on a scale||Standard Deviation|Mean
2661356|NCT01571284|Secondary|Change From Baseline in HRQL EORTC QLQ-C30 Score: Symptom Scales|EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) & other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health & quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best quality of life for participant.|Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at EOT (within 30 days of last treatment) (maximum exposure: 214 weeks)|"EORTC QLQ-C30 analysis population. Here, Number Analyzed = participants analyzed at specified timepoints."|||units on a scale||Standard Deviation|Mean
2661365|NCT01571284|Primary|Number of Participants With Other Abnormal Biochemistry Parameters|Other abnormal biochemistry parameters included: hypoglycemia, hyperglycemia and hypoalbuminemia. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4) as per NCI CTCAE Version 4.03, where Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population. Here, 'Number Analyzed' = participants with available data for specified categories.|||Participants|||Count of Participants
2661470|NCT01569763|Secondary|Procedure Time|Procedure time is defined as the time from device insertion to time of device removal.|< 1 hour|Subjects completing treatment|||Minutes||Standard Deviation|Mean
2661357|NCT01571284|Secondary|Mean Change From Baseline in HRQL EORTC QLQ-C30 Score: Functional Scales|EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) & other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health & quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28).Answers were converted into grading scale, with values between 0 and 100. A high score represented a favourable outcome with a best quality of life for participant.|Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at EOT (within 30 days of last treatment) (maximum exposure: 214 weeks)|EORTC QLQ-C30 analysis population. Here, ‘Number Analyzed’ = participants analyzed at specified timepoints.|||units on a scale||Standard Deviation|Mean
2661358|NCT01571284|Secondary|Mean Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment for Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30 Score): Global Health Status|EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) & other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health & quality of life, coded on 7-point scale (1=very poor to 7=excellent).EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 & 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favourable outcome with a best quality of life for participant.|Pre-dose at Baseline, Day 1 of every odd cycle (from Cycle 3 to 35); at the end of treatment (EOT) (within 30 days of last treatment) (maximum exposure: 214 weeks)|EORTC QLQ-C30 analysis population: participants who signed informed consent form; had an evaluable QLQ-C30 questionnaire at baseline and at least one evaluable assessment post baseline and received at least part of one dose of study treatment (either Aflibercept or FOLFIRI). Here, 'Number Analyzed' = participants analyzed at specified timepoints.|||units on a scale||Standard Deviation|Mean
2661359|NCT01571284|Primary|Number of Participants With Cycle Delay and/or Dose Modification|A theoretical cycle is a 2 week period i.e. 14 days. A cycle is delayed if duration of previous cycle is greater than 14+2 days ; dose modification includes dose reduction and dose omission.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population defined as the participants who signed the informed consent form and received at least one dose of study treatment.|||Participants|||Count of Participants
2661360|NCT01571284|Primary|Number of Participants With Proteinuria (Grade>=2) Concomitant With Hematuria and /or Hypertension|Proteinuria is defined as the presence of excess proteins in the urine (assessed either by spot sample, dipstick/ urine protein or 24 hour urine collection). Hematuria is defined as the presence of blood in urine (positive dipstick for RBC or reported AE). Number of participants with proteinuria grade >=2 (graded as per NCI CTCAE Version 4.03), where Grade>=2 represents moderate to life-threatening/disabling event. Hypertension (high blood pressure) is defined as having a blood pressure reading of more than 140/90 mmHg over a number of weeks.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population.|||Participants|||Count of Participants
2661361|NCT01571284|Primary|Number of Participants With Urinary Protein-Creatinine Ratio (UPCR)|Urinary protein creatinine ratio (UPCR) corresponds to the ratio of the urinary protein and urinary creatinine concentration (expressed in mg/dL). This ratio provides an accurate quantification of 24-hours urinary protein excretion. There is a high correlation between morning UPCR and 24-hour proteinuria in participants with normal or reduced renal functions. Normal ratio is < or = 1.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population. Here, 'Number Analyzed = participants with available data for specified categories.|||Participants|||Count of Participants
2661362|NCT01571284|Primary|Number of Participants With Proteinuria Grade >=2|Proteinuria is defined as the ratio of protein to creatinine. Number of participants with proteinuria grade >=2 (graded as per NCI CTCAE Version 4.03), where Grade>=2 represents moderate to life-threatening/disabling event.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population|||participants|||Number
2661363|NCT01571284|Primary|Number of Participants With Proteinuria Events|Proteinuria is defined as the ratio of protein to creatinine. Number of participants with proteinuria were analyzed by grades (Grades 1, 2, 3 ,4) as per NCI CTCAE Version 4.03 where Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population.|||Participants|||Count of Participants
2661364|NCT01571284|Primary|Number of Participants With Abnormal Non-Gradable Biochemistry Parameters|Non-gradeable biochemistry parameters included; chloride, urea, total protein, blood urea nitrogen (BUN) and lactate dehydrogenase (LDH). Number of participants with <lower limit of normal ranges (LLN) and >upper limit of normal ranges (ULN) for each of these parameters were reported.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population. Here, 'Number Analyzed = participants with available data for specified categories.|||Participants|||Count of Participants
2661379|NCT01570868|Primary|Number of Participants With Complete Cytogenetic Response (CCyR)|Proportion of participants with previously-untreated accelerated phase CML attaining complete cytogenetic response (CCyR) at 6 months of treatment with Ponatinib classified according to suppression of the Philadelphia chromosome (Ph) by cytogenetics (FISH if cytogenetic analysis not informative, e.g., insufficient metaphases). CCyR defined as Ph positive 0%.|6 months||||Participants|||Count of Participants
2661366|NCT01571284|Primary|Creatinine Clearance of Aflibercept Plus FOLFIRI|Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance was calculated using the Cockroft-Gault or Modification of Diet in Renal Disease (MDRD).|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population. Overall number of participants analyzed = participants evaluable for this outcome measure.|||mL/min||Standard Deviation|Mean
2661367|NCT01571284|Primary|Number of Participants With Abnormal Renal and Liver Function Parameters|Renal and liver function parameters included: creatinine, hyperbilirubinemia, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4) as per NCI CTCAE version 4.03, where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population. Here, 'Number Analyzed' = participants with available data for specified categories.|||Participants|||Count of Participants
2661368|NCT01571284|Primary|Number of Participants With Abnormal Electrolytes Parameters|Abnormal electrolytes parameters included: hyponatremia, hypernatremia, hypocalcemia, hypercalcemia, hypokalemia, and hyperkalemia. Number of participants with each of these parameters were analyzed by grades ( All Grades and Grades 3-4 as per NCI CTCAE Version 4.03, where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population. Here, 'Number Analyzed' = participants with available data for specified categories.|||Participants|||Count of Participants
2661369|NCT01571284|Primary|Number of Participants With International Normalized Ratio (INR)|The INR is a derived measure of the prothrombin time. The INR is the ratio of a participant's prothrombin time to a normal control sample. Normal range (without anti coagulation therapy): 0.8-1.2; Targeted range (with anti coagulation therapy) 2.0-3.0.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population. Here, 'Number Analyzed' = participants with available data for specified categories.|||Participants|||Count of Participants
2661370|NCT01571284|Primary|Number of Participants With Abnormal Hematological Parameters|Abnormal hematological parameters included: anaemia, thrombocytopenia, leukopenia and neutropenia. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4 as per NCI CTCAE (Version 4.03), where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population. Here, 'Number Analyzed = participants with available data for specified categories.|||Participants|||Count of Participants
2661371|NCT01571284|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. A serious AE (SAE): Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Version 4.03 was used to assess severity (Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling) of AEs.|Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks)|Safety population defined as the participants who signed the informed consent form and received at least part of one dose of study treatment.|||Participants|||Count of Participants
2661372|NCT01571232|Secondary|The Change in Mean Central Amplitude on Multi-focal ERG From Baseline.|To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm.|6 months||||nV/deg2||Standard Error|Mean
2661373|NCT01571232|Secondary|The Change in Mean Macular Sensitivity on Microperimetry From Baseline|To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.|6 months|||||||
2661374|NCT01571232|Secondary|The Change in Macular Leakage on Fluorescein Angiography From Baseline|To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm.|6 months|||||||
2661375|NCT01571232|Primary|The Change in Central Foveal Thickness (Microns on High Resolution OCT).|The measure the change in central foveal thickness for each treatment group from baseline to 6 months.|6 months||||microns||Standard Error|Mean
2661376|NCT01571232|Primary|The Change in Visual Acuity (Number of ETDRS Letters).|The measure the change in ETDRS letters for each treatment group from baseline to 6 months.|6 months||||ETDRS letters||Standard Error|Mean
2661377|NCT01570868|Secondary|Toxicity Profile: Most Common Grade 3-4 Non-Hematologic Adverse Events (AEs) Seen in More Than 1 Participant|Time to toxicity monitoring defined as any grade 3 or 4 drug-related non-hematologic adverse event that has not resolved to grade 2 or less after 6 weeks of optimal therapeutic management, or drug-related toxicity of any grade that in the opinion of the investigator prevents further therapy with ponatinib. Time to toxicity monitored using the Bayesian method of Thall, et al.|3 months|One participant was not included in analysis.|||Participants|||Count of Participants
2661378|NCT01570868|Primary|Number of Participants With Complete Cytogenetic Response (CCyR)|Proportion of participants with previously-untreated accelerated phase CML receiving treatment of Ponatinib achieving a Complete cytogenetic response (CCyR). Classified according to suppression of the Philadelphia chromosome (Ph) by cytogenetics (FISH if cytogenetic analysis not informative, e.g., insufficient metaphases. CCyR is defined as Ph positive 0%.|Up to 24 months||||Participants|||Count of Participants
2661408|NCT01570387|Primary|Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 3 Milligram Dose|Number of patients in Phase I cohort 2 experiencing dose limiting toxicity in the 3 milligram dose level, cohort 2.|One month||||Participants|||Count of Participants
2661380|NCT01570751|Secondary|Number of Adverse Events (AEs)|Number of treatment emergent adverse events (TEAEs) from week 0 to week 16 of the randomised treatment periods. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. TEAEs were attributed to the treatment given in the period in which the event occurred.|From baseline to the end of each 16 week treatment period.|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.|||events|||Number
2661381|NCT01570751|Secondary|Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B|Values of FPG in mmol/L from the end of treatment period A until after 4 weeks of treatment in treatment period B.|Week 16, week 20|The FAS included all randomised subjects and missing data was imputed using LOCF. For 19 subjects the FPG values were missing.|||mmol/L||Standard Deviation|Mean
2661382|NCT01570751|Secondary|Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period|Values of FPG in mmol/L from baseline to each 16 weeks of treatment periods.|Week 0, week 16, week 32|The FAS included all randomised subjects and missing data was imputed using LOCF. For 17 subjects in IDeg treatment A and 16 subjects in IGlar treatment B, FPG values were missing at the period of baseline and did not contribute to the analysis.|||mmol/L||Standard Deviation|Mean
2661383|NCT01570751|Secondary|Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B|SF-36 and TRIM-DD total scores were measured at the end of treatment A (week 16) and 4 weeks into treatment B (week 20). Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively.|Week 16, week 20|The FAS included all randomised subjects. For 10 subjects, the PRO scores were missing.|||scores on a scale||Standard Deviation|Mean
2661384|NCT01570751|Secondary|Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period|Changes in subjects quality of life and insulin device satisfaction were evaluated using the following PROs: the Short-Form 36 Health Survey version 2 (SF-36) and the Treatment Related Impact Measure-Diabetes Device (TRIM-DD). PRO total scores were measured from baseline to the end of each 16-week treatment period. Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively.|Week 0, week 16 of each treatment period.|The FAS included all randomised subjects and missing data was imputed using LOCF. For 8 subjects in each treatment group the values were missing at the period of baseline and did not contribute to the analysis.|||scores on a scale||Standard Deviation|Mean
2661385|NCT01570751|Primary|Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period|Values for change in HbA1c after each 16 weeks of treatment periods A and B.|Week 0, week 16 of each treatment period.|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 7 subjects in IDeg treatment A and 7 subjects in IGlar treatment B, HbA1c values were missing at the period of baseline and did not contribute to the analysis.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2661386|NCT01570686|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death||8 weeks|Safety Set (SAF): consisted of all patients who received at least one dose of randomized study medication.|||Patients|||Number
2661387|NCT01570686|Secondary|Change From Baseline to Week 8 in Plasma Renin Concentration (PRC)|Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin concentration (PRC). Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8). The difference between baseline and week 8 was calculated.|Baseline, Week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with both baseline and week 8 measurement for PRC are included in this analysis.|||ng/L||Standard Deviation|Mean
2661388|NCT01570686|Secondary|Change From Baseline to Week 8 in Plasma Renin Activity (PRA)|Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin activity (PRA) . Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8).The difference between baseline and week 8 was calculated.|Baseline, Week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with both baseline and week 8 measurement for PRA are included in this analysis.|||ng/mL/hr||Standard Deviation|Mean
2661389|NCT01570686|Secondary|Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration in Fasted vs. Fed|Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.|Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)|Pharmacokinetics set included all patients who had evaluable aliskiren concentration data with no protocol deviations that presumably affect PK results were included in the pharmacokinetic evaluations.|||Hour||Standard Deviation|Mean
2661390|NCT01570686|Secondary|Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) in Fasted vs. Fed|Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.|Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)|Pharmacokinetics set included all patients who had evaluable aliskiren concentration data with no protocol deviations that presumably affect PK results were included in the pharmacokinetic evaluations.|||ng*h/mL||Standard Deviation|Mean
2661391|NCT01570686|Secondary|Pharmacokinetic (PK) of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration in Fasted vs. Fed|Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.|Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)|Pharmacokinetics set included all patients who had evaluable aliskiren concentration data with no protocol deviations that presumably affect PK results were included in the pharmacokinetic evaluations|||ng/mL||Standard Deviation|Mean
2661409|NCT01570387|Primary|Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 2 Milligram Dose|Number of patients in Phase I cohort 1 experiencing dose-limiting toxicity at the 2 milligram dose of pomalidomide combined with dexamethasone in subjects with previously- treated light-chain amyloidosis|one month||||Participants|||Count of Participants
2661392|NCT01570686|Secondary|Percentage of Patients Achieving a Successful Response in Systolic Blood Pressure Reduction|Successful response in systolic blood pressure reduction at end of 8-week treatment was defined as msSBP <140 mmHg or a reduction in msSBP ≥ 20 mmHg from baseline.|Baseline, Week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with mean sitting SBP measurement at baseline and over 8 weeks were included in this analysis.|||Percentage of patients|||Number
2661393|NCT01570686|Secondary|Change From Baseline (Visit 3) to End of Study (8 Weeks) in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)|Sitting blood pressure (BP) was measured at trough (approximately 24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the BP was checked in both arms and the arm with higher systolic BP (SBP) was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures (msSBP and msDBP) were measured four times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 2 minute intervals and the mean of all four sitting blood pressure measurements was used as the average sitting office blood pressure for that visit. The analysis of covariance (ANCOVA) model used treatment, region as factors, and baseline as covariate.|Baseline, Week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with official mean sitting blood pressure measurements both at baseline and week 8 were icluded in this analysis.|||mmHg||Standard Error|Least Squares Mean
2661394|NCT01570686|Secondary|Percentage of Patients Achieving Blood Pressure Control|Patients achieving blood pressure control were patients who, at week 8, had a mean sitting systolic blood pressure (msSBP)/ mean sitting diastolic blood pressure (msDBP) < 140/90 mmHg|8 weeks|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with mean sitting blood pressure measurement over 8 weeks were included in this analysis.|||Percentage of patients|||Number
2661395|NCT01570686|Secondary|Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)|24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maDBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate.|Baseline, week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with ABPM measurements at both baseline and week 8 were included in this analysis.|||mmHg||Standard Error|Least Squares Mean
2661396|NCT01570686|Primary|Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)|24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maSBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate.|Baseline, week 8|Full Analysis Set (FAS): consisted of all randomized patients. Mis-randomized patients were excluded from the FAS. Patients with ABPM measurements at both baseline and week 8 were included in this analysis.|||mmHg||Standard Error|Least Squares Mean
2661397|NCT01570634|Secondary|Side-effects and Complications|Compare side-effects and complications|42 days|The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.||||||
2661398|NCT01570634|Secondary|Absence of Relapse|Compare sustained clinical response|42 days|The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.||||||
2661399|NCT01570634|Secondary|Resolution of Abdominal Pain|Compare time to resolution of abdominal pain|14 days|The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.||||||
2661400|NCT01570634|Secondary|Stools Per Day|Compare the number of liquid stools per day during treatment period|14 days|The study was terminated early due to slow enrollment. One of the two patients enrolled took less than 50% of the prescribed study drug.||||||
2661401|NCT01570634|Primary|Resolution of Diarrhea|To evaluate the safety and efficacy of CASAD added to the standard-of-care for the therapy of Clostridium difficile infection (C. difficile).|42 days|The study was terminated early due to slow enrollment. Of the 2 patients enrolled, one took less than 50% of the prescribed study drug. The results are not evaluable.||||||
2661402|NCT01570491|Secondary|Time to Perform Block (Second)|Time to perform block (from first needle insertion to injection of medication)|as measured in seconds after needle insertion, surgical date||||second||Inter-Quartile Range|Median
2661403|NCT01570491|Secondary|Patient Satisfaction|Record patient satisfaction on a five-point Likert scale, where a value of 1 indicates extremely unsatisfied and a value of 5 indicates extremely satisfied.|after insert the block but before the surgery||||units on a scale||Inter-Quartile Range|Median
2661404|NCT01570491|Secondary|Difficulty of Block Insertion|Difficulty of insertion, was rated by the performing anesthesiologist on a 10-point Likert scale from one (easy) to ten (extremely difficult)|10-15 minutes before the surgery||||units on a scale||Inter-Quartile Range|Median
2661405|NCT01570491|Primary|Number of Attempts|Number of attempts (defined as number of needle reinsertions form the skin and NOT number of redirection of the needle) at the beginning of surgery|10-15 minutes before the surgery||||Attempts||Inter-Quartile Range|Median
2661406|NCT01570387|Secondary|Response to the Maximal Tolerated Dose|Number of participants with a response to treatment at that maximal tolerated dose (including partial, very good, or complete responses)|one year|Number of evaluable patients treated at the maximal tolerated dose of 4mg including the Phase I cohort 3 participants and the Phase II expansion participants|||Participants|||Count of Participants
2661407|NCT01570387|Primary|Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 4 Milligram Dose|Number of patients in Phase I cohort 3 experiencing dose-limiting toxicity at the 4 milligram dose for participants within the third dose cohort|One month||||Participants|||Count of Participants
2668474|NCT01505764|Secondary|Functional Performance.|Functional performance using stair-climbing power day 84 percent change from baseline|day 84|only two subjects in each group completed this measure.|||percentage change||Standard Deviation|Mean
2661410|NCT01570348|Secondary|Treatment-related Mortality (TRM)|A stopping rule will be imposed for TRM occurring within one year of transplant. The study will be stopped if at any point there is moderately strong evidence that the rate of TRM exceeds 10%. Moderately strong evidence will be taken to mean that the lower bound of a one-sided 80% confidence interval for the true rate of TRM is above 10%.|Time from BMT to death definitely or probably resulting from treatment, assessed up to 5 years||||Participants|||Count of Participants
2661411|NCT01570348|Secondary|Regimen-related Toxicity Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4|Characterized by the rates of reportable events as functions of all patients enrolled and at risk of the event, with exact confidence intervals. With the exception of adverse events (AEs) that are universal and expected following conditioning therapy, all reportable AEs will be tabulated for each patient from the time that the subject starts mobilization of hematopoietic cells until day +365 after transplant.|Up to 1 year post-BMT||||Participants|||Count of Participants
2661412|NCT01570348|Secondary|Quality of Life Measured Using the Previously Validated Short Inflammatory Bowel Disease Questionnaire||Up to 5 years||||Participants|||Count of Participants
2661413|NCT01570348|Secondary|Overall Survival|Characterized by the event rates as functions of all patients enrolled and at risk of the event, with exact confidence intervals.|Time of treatment assignment until death due to any cause, assessed up to 5 years||||Participants|||Count of Participants
2661414|NCT01570348|Secondary|Incidence of Graft Rejection|Engraftment is defined as achieving > 5% donor peripheral blood CD3 T cell chimerism by day 84 after HCT. Primary graft failure is defined as a donor peripheral blood CD3 T cell chimerism peak of < 5% by Day 84 post-HCT. Secondary graft failure is defined as documented engraftment followed by loss of the graft with donor peripheral blood CD3 T cell chimerism < 5% as demonstrated by a chimerism assay.|Up to 5 years||||Participants|||Count of Participants
2661415|NCT01570348|Secondary|Incidence of Disease-modifying Drugs for CD Initiated Post-transplant|Includes the administration of any therapy (drugs, biologics, or any other treatments) clearly given as immunomodulatory therapy for underlying CD.|Up to 5 years||||Participants|||Count of Participants
2661416|NCT01570348|Secondary|Incidence and Severity of GVHD|The grading of acute and chronic GVHD will follow previously published guidelines but will also include capture of symptoms and characterization of alternative causes. The highest level of organ abnormalities, the etiologies contributing to the abnormalities and biopsy results pertaining to GVHD will be identified. Since both GVHD and CD involve the gastrointestinal tract, all diagnostic biopsies of these organs will be reviewed by pathologists experienced in the diagnosis of GVHD and IBD, respectively.|Up to 5 years||||Participants|||Count of Participants
2661417|NCT01570348|Secondary|EFS|Described graphically using a Kaplan-Meier estimate. Generated with confidence intervals using Greenwood's formula to calculate the standard error. Estimated with exact 90% confidence intervals.|Up to 5 years post-transplant||||Participants|||Count of Participants
2661418|NCT01570348|Secondary|Disease Activity|Evaluated using a standardized tool for evaluating CD (CDAI).|Up to 5 years||||Participants|||Count of Participants
2661419|NCT01570348|Secondary|Development of Infectious Complications|The incidence of definite and probable viral, fungal and bacterial infections will be tabulated for each patient.|Up to 5 years||||Participants|||Count of Participants
2661420|NCT01570348|Primary|Event-free Survival (EFS)|Defined as alive and free of active CD. Described graphically using a Kaplan-Meier estimate. Generated with confidence intervals using Greenwood's formula to calculate the standard error. Estimated with exact 90% confidence intervals.|At 1 year post-transplant||||Participants|||Count of Participants
2661421|NCT01570309|Primary|Inflammation|Median within subject change in IL-12 levels between baseline and week 12 in active and placebo groups|Baseline to week 12||||pg/ml||Inter-Quartile Range|Median
2661422|NCT01570309|Primary|Inflammation|Median within subject change in cxcl-10 .levels between baseline and week 12 in active and placebo groups|Baseline to 12 weeks||||pg/ml||Inter-Quartile Range|Median
2661423|NCT01570309|Primary|Inflammation|Median within subject change in interferon-gamma levels between baseline and week 12 in active and placebo groups|Baseline to 12 weeks||||pg/ml||Inter-Quartile Range|Median
2661424|NCT01570309|Primary|Inflammation -|Median within subject change in hs-CRP levels between baseline and week 12 in active and placebo groups|Baseline and 12 weeks||||mg/dl||Inter-Quartile Range|Median
2661425|NCT01570309|Primary|Endothelial Function|Endothelial function was measured using peripheral arterial tonometry expressed as the reactive hyperemia index. The index is derived from the ratio of the post-to-pre occlusion peripheral arterial tonometry signal amplitude of the tested arm, divided by the post -to-pre occlusion ratio of the control arm. Median within subject change in endothelial function as measured by reactive hyperemia peripheral arterial tonometry index in each group is presented.|Baseline and 12 weeks|Assuming a standard deviation of 0.6 in the change in RH-PAT score from baseline to 12 weeks, we estimated that the study would need a sample size of 45 patients per treatment group to have 80% power at a two tailed alpha=0.05 level to detect a minimum difference in change in RH-PAT score of 0.36 between treatment groups.|||reactive hypermia index||Inter-Quartile Range|Median
2661426|NCT01570283|Secondary|Median Peak Frequency of Specific T Cells Post-infusion|Median peak frequency of specific T cells as measured by Elispot to assess reconstitution of antiviral immunity.|3 months|Data is reported for all participants who received multivirus-specific CTLs for treatment of EBV, CMV, adenovirus, HHV6 and BK virus.|||spot forming cells/5 * 10^5 input cells||Full Range|Median
2661427|NCT01570283|Secondary|Percentage Change of Viral Load From Baseline to Follow-up|Percentage change of viral load by PCR from baseline to follow-up. A positive number indicates a percentage decrease and a negative number indicates a percentage increase.|3 months|Data is reported for all participants who received multivirus-specific CTLs for treatment of EBV, CMV, adenovirus, HHV6 and BK virus.|||percentage change||Full Range|Median
2661428|NCT01570283|Secondary|Percentage of Patients Who Have a Response in Anti-viral Activity|Percentage of patients who have a response in anti-viral activity that is defined as a viral load reduction to the normal level for at least one of the five virus types|42 days|Data is reported for all participants who received multivirus-specific CTLs for treatment of EBV, CMV, adenovirus, HHV6 and BK virus.|||percentage of participants||95% Confidence Interval|Number
2661429|NCT01570283|Primary|Number of Participants With a DLT|DLT is defined as acute GvHD grades III-IV within 42 days of the last dose of CTLs, # of patients with Grade 3-5 infusion-related adverse events within 30 days of the last dose of CTLs, and # of patients with Grade 4-5 non-hematological adverse events within 30 days of the last dose of CTLs. GVHD grade III-IV scoring is based on the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) GVHD scoring stamp or equivalent. Grade 3-5 infusion-related adverse events and Grade 4-5 non-hematological adverse events are graded by the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.X.|42 days|Data is reported for all participants who received multivirus-specific T cells. A participant is not evaluable for DLT if the participant was removed from the study before 42 days follow up due to a reason other than DLT.|||Participants|||Count of Participants
2661430|NCT01570244|Primary|C24,ss of Levonorgestrel|measured concentration of the analyte at the end of dosing interval under steady state conditions of levonorgestrel|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2661431|NCT01570244|Primary|Cmax,ss of Levonorgestrel|maximum measured concentration over the uniform dosing interval under steady state conditions of levonorgestrel|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2661432|NCT01570244|Primary|AUCτ,ss of Levonorgestrel|Area under the curve over the dosing interval τ under steady state conditions of levonorgestrel|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2661433|NCT01570244|Secondary|Number of Participants With Drug Related Adverse Events|number of participants with investigator-defined drug related adverse events|from drug administration up to 14 days|treated set|||participants|||Number
2661434|NCT01570244|Secondary|Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG.|Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|from drug administration up to 14 days|Treated set: This subject set included all 16 subjects who were administered trial medication and were documented to have taken at least 1 dose of investigational treatment.|||participants|||Number
2661435|NCT01570244|Primary|C24,ss of Ethinylestradiol|measured concentration of the analyte at the end of dosing interval under steady state conditions of ethinylestradiol|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2661436|NCT01570244|Primary|Cmax,ss of Ethinylestradiol|maximum measured concentration over the uniform dosing interval under steady state conditions of ethinylestradiol|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration|PK set|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2661437|NCT01570244|Primary|AUCt,ss of Ethinylestradiol|Area under the curve over the dosing interval t under steady state conditions of ethinylestradiol|on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 hours (h) after drug administration|Pharmacokinetic (PK) set: all subjects in the treated set who provided at least 1 observation for at least 1 primary pharmacokinetic endpoint, who did not have important protocol violations relevant to the evaluation of PK endpoints, and who did not have vomiting until 2·median tmax,ss of ethinylestradiol or levonorgestrel on Day 13 or on Day 8.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2661438|NCT01570192|Secondary|Mortality|Percentage of patients who died by efficacy endpoint, treatment group and population (n/N)|28 days|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.|||Participants|||Count of Participants
2661439|NCT01570192|Secondary|Mortality|Percentage of patients who died by efficacy endpoint, treatment group and population (n/N)|14 days|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.|||Participants|||Count of Participants
2661440|NCT01570192|Secondary|Occurrence of Repeat Negative Cultures|Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)|Day 5/Early Extubation|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.|||Participants|||Count of Participants
2661441|NCT01570192|Secondary|Suppression of the Emergence of Resistance in Other Gram-negative Pathogens|Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)|Day 5/Early Extubation|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.|||Participants|||Count of Participants
2661442|NCT01570192|Secondary|Pretreatment Pathogen Response|Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)|End of treatment - up to 28 days after enrollment|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.|||Participants|||Count of Participants
2661443|NCT01570192|Secondary|Overall Microbiologic Response|Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)|End of treatment - up to 28 days after enrollment|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.|||Participants|||Count of Participants
2661444|NCT01570192|Secondary|Clinical Response in Subjects Who Received Prior Antibiotics|Percentage of patients with successful responses by efficacy endpoint, treatment group and population (n/N)|End of treatment - up to 28 days after enrollment|The ME population, 19 subjects were analyzed and the m-MITT population, 24 were analyzed. Not all subjects were evaluable for each endpoint.|||Participants|||Count of Participants
2661761|NCT01566773|Secondary|Mean Number of Puffs of Rescue Medication (End of Treatment)|Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated|Day 14 (End of treatment)|MITT Population|||Puffs||95% Confidence Interval|Mean
2661446|NCT01570192|Primary|Number of Participants With Suppression and Emergence of Resistance|The emergence of resistance is defined as a change of meropenem MIC or aminoglycoside MIC by two tube dilutions (fourfold) from baseline when assessed at the second BAL procedure on day 5/early extubation. Patients are evaluable for this endpoint IF they had baseline BAL and Day 5/early extubation and if they had positive cultures on baseline and Day/EE.|up to 28 days after enrollment|All patients in the ME population with BAL at baseline and at Day 5/EE and pathogens collected at baseline BAL and at Day 5/EE BAL.|||participants|||Number
2661447|NCT01569841|Secondary|Number of Treatment Emergent Confirmed Hypoglycaemic Episodes|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of investigational medicinal product (IMP), and no later than 7 days after the last day on trial product. Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia or minor hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L.|Hypoglycemic episodes reported within each 6 week treatment period.|The SAS included all subjects who received at least one dose of the investigational product or its comparator.|||events|||Number
2661448|NCT01569841|Secondary|Number of Treatment Emergent Adverse Events (AEs)|Number of treatment emergent adverse events (TEAEs). An AE was defined as treatment emergent if the onset date was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.|Within each week 6 treatment period|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.|||events|||Number
2661449|NCT01569841|Secondary|Glycosylated Haemoglobin (HbA1c)|HbA1c after 6 weeks of treatment in each treatment period.|At the end of each 6 week treatment period.|The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2661450|NCT01569841|Secondary|Fasting Plasma Glucose (FPG)|FPG after 6 weeks of treatment in each treatment period.|At the end of each 6 week treatment period.|The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.|||mmol/L||Standard Deviation|Mean
2661451|NCT01569841|Secondary|Mean Interstitial Glucose (IG) Based on 14 Days of CGM|The observed mean of IG profile was obtained as the average value of area under the IG profile divided by the actual assessment time interval during the last 2 weeks of the 6-week treatment period.|CGM monitoring occurred during the last 2 weeks of the 6-week treatment period.|The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.|||mmol/L||Standard Deviation|Mean
2661452|NCT01569841|Primary|Average Time Within Glycaemic Target Range (Above 70 mg/dL and Below 130 mg/dL)|Time within the glycaemic target range [> 70 mg/dL (3.9 mmol/L) and < 130 mg/dL (7.2 mmol/L)] measured by Continuous Glucose Monitoring (CGM) in the last four hours of each dosing interval during the last 2 weeks of the 6-week treatment period.|CGM occured during the last 2 weeks of the 6 weeks treatment period.|The FAS included all randomised subjects. One subject from the IGlar to IDeg treatment sequence withdrew from the trial during treatment period A while taking IGlar.|||hours||Standard Deviation|Mean
2661453|NCT01569828|Primary|CLr After Multiple Dose Administration (Day 5)|Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696|5 days|Pharmacokinetic analysis set|||(ml/hr)||Standard Deviation|Mean
2661454|NCT01569828|Primary|CL/F After Multiple Dose Administration (Day 5)|Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696|5 days|Pharmacokinetic analysis set|||(ml/hr)||Standard Deviation|Mean
2661455|NCT01569828|Primary|T1/2 After Multiple Dose Administration (Day 5)|Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696|5 days|Pharmacokinetic analysis set|||(hr)||Standard Deviation|Mean
2661456|NCT01569828|Primary|AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)||1 and 5 days|Pharmacokinetic analysis set|||(hr*ng/mL)||Standard Deviation|Mean
2661457|NCT01569828|Primary|(Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)||1 and 5 days|Pharmacokinetic analysis set|||ng/mL||Standard Deviation|Mean
2661458|NCT01569828|Secondary|24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers||5 days||||mmol/day||Standard Deviation|Mean
2661459|NCT01569828|Primary|Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)||1 and 5 days|Pharmacokinetic analysis set|||hour||Full Range|Median
2661460|NCT01569815|Secondary|Change in Mean 24-hours Sodium Clearance From Baseline to Day 7|Sodium clearance will be measured in urine from baseline until Day 7|From baseline to Day 7|FAS|||mmol/day||Standard Deviation|Mean
2661461|NCT01569815|Primary|Amount of Drug Excreted Into the Urine From Time Zero to 24-hours Post-dose (Ae0-24) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 1 and Day 5||||ug||Standard Deviation|Mean
2661462|NCT01569815|Primary|Renal Clearance From Plasma (CLr) After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 5|FAS|||mL/hr||Standard Deviation|Mean
2661463|NCT01569815|Primary|Accumulation Ratio (Racc) After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 5|FAS|||Ratio (AUC0-24, day 5)/(AUC0-24, day 1)||Standard Deviation|Mean
2661464|NCT01569815|Primary|Systemic Clearance From Plasma Following Extravascular Administration (CL/F) After Multiple Dose Administration (Day 5)|Blood samples will be collected for the determination of plasma concentrations of VAL489 (valsartan), AHU377( Sacubitril) and LBQ657 (a human metabolite of sacubitril)|Day 5||||mL/hr||Standard Deviation|Mean
2662675|NCT01560260|Secondary|Progression Free Survival (PFS)|Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.|Time from date of enrollment to time of progression or death due to any cause, estimates at 9 months||||percentage of participants|||Number
2661471|NCT01569763|Primary|Reduction of Menstrual Bleeding to Normal or Below Normal at 12 Months|Clinical success was defined as a reduction in menstrual bleeding volume to ≤ 80 ml as measured by the alkaline hematin method (AH). Clinical success was not achieved if: (1) at one year post-treatment menstrual blood loss is greater than 80ml, as measured by AH; (2) an acute failure occurred (e.g., aborted procedure, etc.); or (3) the subject required additional therapy to control menorrhagia.|12 months|All Randomized subjects in whom treatment was attempted|||participants|||Number
2661472|NCT01569737|Primary|Number of Participants Who Experienced Assessed Pregnancy Outcomes|"Live birth outcomes:~Healthy baby; Congenital anomaly: a baby born with a congenital anomaly; Neonatal death: a newborn who died during the first 28 days of life; Preterm birth: a baby born at less than 37 weeks of gestational age;~Pregnancy loss outcomes:~Ectopic pregnancy: implantation of the fertilized egg and pregnancy development in a location outside the uterus and attempt to develop in this location; Spontaneous abortion: early fetal death (i.e. less than 20 completed weeks of gestation);~Fetal death:~Intermediate fetal death (between greater than 20 and less than 28 completed weeks of gestation); Late fetal death (greater or equal to 28 completed weeks of gestation);~Induced abortions can be either:~An induced abortion for non-medical reason; An induced abortion for medical reasons (termination of pregnancy for fetal anomaly, or for other pregnancy or maternal health complications)"|up to 9 months after pregnancy diagnosis|Pregnancy outcomes were described for pregnancies with known outcome (patients with missing outcomes and patients lost to follow-up were excluded from the descriptive analyses).|||Participants|||Count of Participants
2661473|NCT01569607|Secondary|Mean Wolf Motor Function Test (WMFT) Grip Strength|Participants attempt to grip the dynamometer with greatest grip strength possible. The test should be conducted 3 times with a 1-minute rest between trials. The mean of grip strength exerted (kg) on 3 trials is then calculated.|Baseline, Post-Training (1 Week), Post-Training (4 Weeks)|Analysis was conducted for participants that completed all study procedures.|||kilograms||Standard Deviation|Mean
2661474|NCT01569607|Secondary|Mean Wolf Motor Function Test Functional Ability (WMFT-FS) Scale Score|The WMFT is a 17 item scale that quantifies upper extremity (UE) motor ability through timed and functional tasks. The items are rated on a 6-point scale.Total scores can range from 17 to 102. Lower scores indicate debilitating mobility (such as no or limited functionality), while higher score indicate greater mobility (such as slow movement and normal movement).|Baseline, Post-Training (1 Week), Post-Training (4 Weeks)|One participant from both arms was removed from the data analysis due to errors in data collection yielding uninterpretable results.|||units on a scale||Standard Deviation|Mean
2661475|NCT01569607|Secondary|Mean Wolf Motor Function Test (WMFT) Total Time|The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks. There are 15 timed tasks included with a time cap of 120 seconds. The max amount of time to completion is 1800 seconds if all tasks are failed. The time in seconds were summed across all the tasks to obtain the total duration. Values in the table represent the time taken in seconds to successfully complete all 15 tasks).|Baseline, Post-Training (1 Week), Post-Training (4 Weeks)|Analysis was conducted for participants that completed all study procedures.|||seconds||Standard Deviation|Mean
2661476|NCT01569607|Secondary|Mean Motor Activity Log (MAL): How Well Subtest|"Individuals are asked to rate quality of movement during 30 daily functional tasks. Items are scored on a 6-point ordinal scale as follows:~0=The weaker arm was not used at all for that activity (never); 1=The weaker arm was moved during that activity, but was not helpful (very poor); 2=The weaker arm was of some use during the activity, but needed help from the stronger arm or moved very slowly or with difficulty (poor); 3=The weaker arm was used for the purpose indicated, but movements were slow or were made with only some effort (fair); 4=The movements made by the weaker arm were almost normal, but were not quite as fast or accurate as normal (almost normal); 5=The ability to use the weaker arm for that activity was as good as before the stroke (normal)~Total scores range from 0 to 140; 0 indicating the least movement and 140 indicating the most movement."|Baseline, Post-Training (1 Week), Post-Training (4 Weeks)|Analysis was conducted for participants that completed all study procedures.|||units on a scale||Standard Deviation|Mean
2661477|NCT01569607|Secondary|Mean Motor Activity Log (MAL) Score: Amount Subtest|"Individuals are asked to rate amount of movement during 30 daily functional tasks. Items are scored on a 0 to 6-point ordinal scale as follows:~0 = The weaker arm was not used at all for that activity (never)~1 = Occasionally used weaker arm, but only very rarely (very rarely)~2= Sometimes used weaker arm, but did the activity most of the time with stronger arm (rarely)~3 = Used weaker arm about half as much as before the stroke (half pre-stroke)~4 = Used weaker arm almost as much as before the stroke (3/4 pre-stroke)~5 = The ability to use the weaker arm for that activity was as good as before the stroke (normal)~Total scores range from 0 to 140; 0 indicating the least movement 140 indicating the most movement. The scores were converted into percentage scores where higher percent score indicate more movement and lower percent score less movement."|Baseline, Post-Training (1 Week), Post-Training (4 Weeks)|Analysis was conducted for participants that completed all study procedures.|||units on a scale||Standard Deviation|Mean
2661478|NCT01569607|Secondary|Mean Reaction Time of Wrist Extension Movements|Subjects will be asked to perform 7 auditory-cued ballistic wrist extensions before and after motor training. Electromyographic (EMG) activity recorded during the ballistic wrist extensions will be used to measure reaction time. Reaction time is the length of time between the auditory cue and the onset of the movement-related EMG burst of the extensor carpi ulnaris muscle. A longer time indicated longer time to reaction.|Baseline, Post-Training (1 Week), Post-Training (4 Weeks)|Three participants from both arms were removed from the data analysis due to errors in data collection yielding uninterpretable results.|||milliseconds||Standard Deviation|Mean
2661479|NCT01569607|Secondary|Mean Peak Acceleration of Wrist Extension Movements|Mean peak acceleration was measured at baseline, one week after the treatment (post-training 1), and four weeks after the treatment (post-training 2). Increases in the mean peak acceleration of the trained wrist extension movements indicate motor learning. Acceleration was measured in g; a symbol for the average acceleration produced by gravity at the Earth's surface.|Baseline, Post-Training (1 Week), Post-Training (4 Weeks)|Three participants from both arms were removed from the data analysis due to errors in data collection yielding uninterpretable results.|||g||Standard Deviation|Mean
2662488|NCT01562327|Secondary|Reason for DMARDs Withdrawal at Baseline||Baseline|FAS defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure.|||participants|||Number
2661480|NCT01569607|Secondary|Mean Time to Completion for Jebsen Hand Function Test (JTT)|The JTT provides a standardized and objective evaluation of fine and gross motor hand function using simulated activities of daily living assessing the speed of performance. Total score is the sum of time taken for each sub-test, which were normalized to standard scores (also expressed in seconds).Total scores range from +1 to -1 where -1 indicates best function.|Baseline, Post-Training (1 Week), Post-Training (4 Weeks)|Analysis was conducted for participants that completed all study procedures.|||units on a scale||Standard Deviation|Mean
2661481|NCT01569607|Primary|Primary Motor Cortex (M1) Excitability Derived From Stimulus Response Curve|Motor evoked potential (MEP) amplitudes were measured prior to treatment (baseline), one week after the treatment (post-training 1), and 4 weeks after treatment (post-training 2).The MEP is elicited by transcranial magnetic stimulation (TMS) at increased intensity. Its amplitude is measured from peak to peak and expressed in millivolts (mV). Measured MEP amplitudes were plotted against the intensity to create a stimulus response curve (SRC). Long-lasting increases in MEP amplitude indicate increases in motor cortex excitability and are associated with motor learning.|Baseline, Post-Training 1 (1 Week), Post-Training 2 (4 Weeks)|Analysis was conducted for participants that completed all study procedures.|||millivolts||Standard Deviation|Mean
2661482|NCT01569594|Primary|Carotid Procedure and Device Related Adverse Events to Determine Device Performance||2 years||||Device related adverse events|||Number
2661483|NCT01569568|Secondary|Neuropsychological Assessment|Testing consisted of the Wechsler Abbreviated Scale of Intelligence (WASI), Comprehensive Trail Making Test (CTMT) (range 17-87), and the Behavioral Rating Inventory of Executive Function (BRIEF) (range GEC: 70-210; BRI:39-82 ; MI:41-92). The WASI includes three measures of intelligence; including, performance IQ (sum of block design and matrices sub scales; range: 40-160), verbal IQ (sum of vocabulary and similarities sub scales; range 40-160), and total IQ (sum of all four subscales; range: 80-320). The CTMT measures simple attention and executive function, it consists of five dot to dots that increase with complexity and difficulty. Higher values indicate better outcomes for all scales.|Baseline||||units on a scale||Standard Deviation|Mean
2661484|NCT01569568|Primary|Fractional Anisotropy Assessed Using DTI|Fractional Anisotropy (FA) is a measure of the diffusion asymmetry within a voxel as defined by its eigenvalues. In our study, FA is being used as a measure of white matter integrity, because FA is very sensitive to small microstructural changes.Fractional anisotropy (FA) is a scalar value between zero and one (0-1) that describe anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions.|Baseline||||units on a scale||Standard Deviation|Mean
2661485|NCT01569568|Primary|Functional Connectivity of Assessed by Resting-state fMRI|Investigation of differences in functional connectivity of OTCD patients compared to healthy controls, particularly in the default-mode network (DMN) and the set-maintenance network (SMN). Participants underwent a resting-state scan using 3T fMRI. Combining independent component analysis (ICA) and region-of-interest (ROI) analyses, identified the nodes that comprised each network in each group, and assessed internodal connectivity. For each subject, this analysis generated a correlation value, which reflected the strength of functional connectivity between each ROI pair.The correlation r-values were normalized using Fisher's r-to-Z-transform, generating z-scores. The DMN was composed of 1) anterior cingulate/medial prefrontal cortex (ACC/mPFC), 2) posterior cingulate cortex (PCC), and 3) bilateral inferior parietal lobule (IPL). The SMN was composed of 1)ACC, 2) bilateral superior frontal gyrus (SFG), and 3) bilateral anterior insula/frontal operculum (aI/fO).|Baseline|Resting state data was not acquired for several of our participants (7 controls and 4 patients). Furthermore, 3 OTCD patients were excluded from the analyses due to excessive head motion.|||z-scores||Standard Deviation|Mean
2661486|NCT01569568|Primary|Concentration of Glutamine and Myoinositol|"Concentration based on area under curve on 1H Magnetic Resonance Spectroscopy(MRS) and quantitated by LCModel (a method that allows automatic quantitation of spectroscopy data). A metabolite's tissue concentration is related to the integrated amplitude, the area under the curve of the MRS signal, it produces. While MRS signals are usually acquired in the time domain as free induction decays or echoes, they are usually viewed and analyzed in the frequency domain. The frequency domain representation is derived from the acquired time domain data by the Fourier Transform. The protocol we use selects 257 averages. The machine summates the data at each time point to generate one value for the area under the curve. Therefore, we don't have the measurement at each time point.~Furthermore, we measured voxels in two different brain areas containing different kinds of brain matter: one voxel was located in posterior cingulate gray matter (PCGM) and the other in parietal white matter (PWM)."|Baseline|Two OTCD patients and one healthy control were excluded due to excessive head motion.|||mM||Standard Deviation|Mean
2661487|NCT01569529|Primary|Program Enrollment|Rates of enrollment will be calculated as the proportion of visitors who enroll in treatment (e.g., number of enrollments/number of click-throughs from banner ads).|1-month intervals over 7 months||||proportion of click-throughs who enroll|Click-through from advertisements||Number
2661488|NCT01569464|Secondary|Change From Baseline in SF-36 Physical Component Summary Score|"The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm-based scores (based on the US general population) were used for analysis. For the PCS, the lowest and highest possible scores are 1 and 81 (rounded).~The SF-36 domains (subscores) are scored so that a higher score indicates a better health state."|Baseline to End of Maintenance Period (7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
2661641|NCT01568424|Primary|Survival|"In patients who recover and do not go on to transplantation or a long-term device: Survival to 30 days post-support or to hospital discharge (whichever is longer).~In patients who do not recover and are bridged to transplant or a long-term system: Survival to induction of anesthesia for implantation of a long-term device or heart transplant."|30 days post device removal||||percentage of survival at 30 days|||Number
2661489|NCT01569464|Secondary|Change From Baseline in SF-36 Mental Component Summary Score|"The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm-based scores (based on the US general population) were used for analysis. For the MCS, the lowest and highest possible scores are -9 and 82 (rounded).~The SF-36 domains (subscores) are scored so that a higher score indicates a better health state."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
2661490|NCT01569464|Secondary|Change In Total Score From Baseline To The End of Maintenance Period On Profile Of Mood States Questionnaire (POMS)|"The Profile of Mood States questionnaire (POMS) total score will be calculated as the sum of the scores for the following 5 scale scores (Tension-Anxiety, Depression-Dejection, Anger-Hostility, Fatigue-Inertia, and Confusion-Bewilderment) and then subtracting the Vigor-Activity score. All factors have to be available for the total score to be calculated; otherwise the total score will be set to missing. The range for the POMS is 0 - 200 with a high score being negative and a low score being positive.~For the POMS questionnaire total score, descriptive statistics will be presented on both the observed and the change from Baseline to the end of the Maintenance Period values for the Full Analysis Set (FAS)."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
2661491|NCT01569464|Secondary|Change From Baseline To The End of Maintenance Period In Sleep Quantity Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (Sleep Scale-R)|"The Medical Outcomes Study (MOS) Sleep Scale-Revised (MOS Sleep-R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.~The MOS Sleep-R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from all of the time to none of the time. The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
2661492|NCT01569464|Secondary|Change From Baseline To The End of Maintenance Period In Sleep Adequacy Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R)|"The Medical Outcomes Study (MOS) Sleep Scale-Revised (MOS Sleep-R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.~The MOS Sleep-R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from all of the time to none of the time. The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
2661493|NCT01569464|Secondary|Change From Baseline To The End of Maintenance Period In Sleep Disturbance Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R)|"The Medical Outcomes Study (MOS) Sleep Scale-Revised (MOS Sleep-R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.~The MOS Sleep-R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from all of the time to none of the time. The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
2661515|NCT01569438|Secondary|Genitourinary Pain Index (GUPI)|The GUPI is an instrument that is used to assess the degree of symptoms in women with genitourinary pain complaints. The sum of the items yields three subscales and a total score. The subscales are pain (0-23), urinary (0-10), and quality of life (0-12). The sum of the subscales is the total score (0-45). Higher scores indicate more severe symptoms.|Baseline and 4 Weeks|Titration Completers Population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase|||units on a scale||Standard Deviation|Mean
2661494|NCT01569464|Secondary|Change From Baseline To The End Of Maintenance Period In Daytime Somnolence Domain Score Of The Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R)|"The Medical Outcomes Study (MOS) Sleep Scale-Revised (MOS Sleep-R) is a self-administered questionnaire measuring several important aspects of sleep that have been validated in both general and patient populations.~The MOS Sleep-R consists of 12-items. Responses for 10 of the 12 items are on a 5-point frequency scale with options ranging from all of the time to none of the time. The other two items ask about the length of time to fall asleep and the average number of hours slept per night. The sleep problems index I allows for the summary of sleep problems using an abbreviated six-item index, whereas the sleep problems index II uses nine of the 12 items of the scale to compute an overall sleep problem summary. A higher score on each scale in summary index represents a lack of sleep problems (better sleep quality). All scores are transformed linearly to range from 0 to 100, with the exception of the sleep quantity subscale, which is scored in hours."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
2661495|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Daytime Tiredness (Item 6 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = not at all) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
2661496|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Severity of Restless Legs Syndrome (RLS) At Daytime In Activity (Item 5 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
2661497|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) At Daytime At Rest (Item 4 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
2661498|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) During The Night (Item 3 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
2661499|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Severity Of Restless Legs Syndrome (RLS) At Bedtime (Item 2 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = none) to (10 = very severe).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
2661500|NCT01569464|Secondary|Change In Item Score From Baseline To The End Of The Maintenance Period In Satisfaction With Sleep (Item 1 of Restless Legs Syndrome 6 Rating Scales [RLS-6])|The RLS-6 is an 11-point scale. This 11-point scale was provided with ranges between (0 = completely satisfied) to (10 = completely dissatisfied).|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
2661501|NCT01569464|Secondary|Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) Change In Average Of Means Of Periodic Limb Movement During Wakefulness Index (PLMWI) For The Combination Of Multiple Suggested Immobilization Test (m-SIT)|"During each single Suggested Immobilization Test (SIT) PLMWI was measured using a validated actigraphy device. Simultaneous actigraphy of the legs was performed by an actigraphy device, which was attached to the ankle prior to the start of the SIT. The PLMWI was recorded while the subject was awake.~Scores ranged from 0 (no symptoms) to 10 (very severe symptoms) and were assessed every 10 minutes within each SIT."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 149 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
2661516|NCT01569438|Secondary|O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)|The ICSI contains 4 items that measured how problematic symptoms were for subjects with bladder pain syndrome. Each question in the ICPI was on a scale of 0-4, where each answer was given a specific rating. The sum of the item scores indicated more problematic symptoms. The index score ranged from 0-16 where higher scores indicated more problematic symptoms.|Baseline and 4 Weeks|Titration Completers Population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase|||units on a scale||Standard Deviation|Mean
2661502|NCT01569464|Primary|Change In Average Of Means Of Multiple Suggested Immobilization Test Discomfort Scale (m-SIT-DS) Values Of Each Individual Suggested Immobilization Test (SIT) For The Combination Of Multiple Suggested Immobilization Test (m SIT)|"The Multiple Suggested Immobilization Test Discomfort Scale (m-SIT-DS) was used for assessment of the sensory components of Restless Legs Syndrome (RLS) symptoms in order to provide a subjective score of the severity of RLS symptoms during each Suggested Immobilization Test (SIT).~Scores ranged from 0 (no symptoms) to 10 (very severe symptoms) and were assessed every 10 minutes within each SIT."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
2661503|NCT01569464|Primary|Change From Baseline To The End Of The Maintenance Period in International Restless Legs Scale (IRLS) Sum Score|"The International Restless Legs Scale (IRLS) was intended to evaluate, in a standardized way, the subjective intensity of major symptoms of Restless Legs Syndrome (RLS) and, in 2 items (9 and 10), the impact of the disease on subjects functioning in daytime activities by use of a 5-point scale for each of a total of 10 items.~In all items, the scores ranged from 0 (not present) to 4 (severe). A sum score across all 10 items was calculated for analysis, which varied between 0 (no RLS symptoms present at all) to 40 (maximum severity in all symptoms)."|Baseline to End of Maintenance Period (approximately 7 weeks)|"Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).~Out of the 150 patients in the FAS, 150 were included in this analysis.~The FAS includes all randomized, treated subjects having valid Baseline measurements for both primary efficacy variables."|||units on a scale||Standard Error|Least Squares Mean
2661504|NCT01569451|Post-Hoc|Exposure Time|Values represent mean duration of treatment.|Measured in three month intervals from baseline to end of study.||||years||Standard Deviation|Mean
2661505|NCT01569451|Secondary|Change in Mean Score on Performance Scales (Baseline to 24 Months)|Performance scales measures patient assessments of disability in mobility (1-6), hand (1-5), vision (1-5), fatigue (1-5), cognitive (1-5), bladder and bowel, sensory (1-5), and spasticity (1-5). The overall measure of performance is the sum of subscales, ranging from 0 to 41. Larger numbers mean more disability, with 0 being no disability and the maximum number being total disability.|Baseline through 24 months|At 24 months (2 years); the end of the study follow up period compared with baseline.|||units on a scale||95% Confidence Interval|Mean
2661506|NCT01569451|Secondary|Percentage of Subjects Worsening One Point or More on the Patient Determined Disease Steps (PDDS) Questionnaire|For PDDS the patient selects an integer 0-8 according to their personal assessment of their degree of ambulatory disability. Larger numbers mean more disability, with 0 being no disability and 8 being bedridden. There is an unclassifiable category as well.|Baseline through 24 months|At any time within the follow up period of 24 months (2 years) out to the last observation.|||Participants|||Count of Participants
2661507|NCT01569451|Secondary|Change From Baseline to 24 Months on the Multiple Sclerosis Functional Composite (MSFC) Z-score|The MSFC consists of Timed 25 Foot Walk Tests, 9 Hole Peg Tests, and the Paced Auditory Serial Addition Test (PASAT), administered by clinicians. The subscales are then converted into Z-scores and averaged to create the MSFC Z-score. Larger values denote improvements.|Observations were recorded at baseline and 24 months.||||units on a scale (MSFC Z score)||95% Confidence Interval|Mean
2661508|NCT01569451|Secondary|Number of Patients That Develop Sustained Accumulation of Disability|Sustained accumulation of disability is defined as a 1 point change or more on the Expanded Disability Status Scale (EDSS); sustained for at least three months. Physicians assess patients' cerebral, optic, brainstem, pyramidal, sensory, cerebellar, and bowel and bladder neurological symptoms. The physician then subjectively rates the patient on the ordinal EDSS scale. The EDSS scale emphasizes ambulatory ability. The EDSS scale ranges in half integer increments from 0.0 to 10.0. Larger numbers mean more disability, with 0.0 being everything normal and 10.0 being death due to MS.|Baseline through 24 months|At any observation within the follow up period of 24 months (2 years) out to the last observation.|||participants|||Number
2661509|NCT01569451|Secondary|Number of Subjects Who Experience Multiple Relapses||Baseline through 24 months|At any time within the follow up period of 24 months (2 years) out to the last observation.|||participants|||Number
2661510|NCT01569451|Secondary|Number of Patients Treated for Relapse With Corticosteroid||Baseline through 24 months|At any time within the follow up period of 24 months (2 years) out to the last observation.|||participants|||Number
2661511|NCT01569451|Secondary|Number of Relapse-free Subjects|Change in neurological symptoms in association with EDSS change is defined as relapse.|Baseline through 24 months|Out to the last observation for each patient within 24 months (2 years) of follow up.|||participants|||Number
2661512|NCT01569451|Secondary|Number of Subjects That Fail Treatment||Baseline through 24 months|At any time within the follow up period of 24 months (2 years) out to the last observation.|||participants|||Number
2661513|NCT01569451|Secondary|Time to Treatment Failure|Time itself is the outcome. Whenever treatment failure occurs for the first time within the follow up period of 24 months (2 years).|Baseline through 24 months|Time itself is the outcome. Whenever treatment failure occurs for the first time within the follow up period of 24 months (2 years). Exposure time varies by patient. See exposure time outcome (post hoc).|||months||95% Confidence Interval|Median
2661514|NCT01569451|Primary|Number of Disease-free Patients|Defined as patients without new lesions on brain MRI using the combined unique lesion approach (CUL), without sustained change in EDSS score over any 3-month period and without relapse. If a clear treatment effect is sustained in the R-GA arm, defined as a ≥ 70% decrease in brain lesions on MRI, using a CUL approach, attributable to MS and ≥ 70% reduction in annual relapse rates, compared to the GA arm, the study will continue under the extension protocol. If induction therapy fails to show superiority, at any point, the study will be stopped.|Baseline through 24 months|Out to the last observation for each patient within 24 months (2 years) of follow up.|||participants|||Number
2661529|NCT01569152|Secondary|Change From Baseline in Hemoglobin at Week 12|Hemoglobin is the iron-containing oxygen-transport metalloprotein in red blood cells. Change from Baseline is hemoglobin at Week 12 minus hemoglobin at Baseline. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had non-missing Baseline and Week 12 hemoglobin values|||gm/dL||Standard Deviation|Mean
2661517|NCT01569438|Secondary|Painful Bladder/Interstitial Cystitis Symptom Diary (PBIC-SD)|The PBIC-SD was an 8-item subject self-report measure for assessing the severity of bladder pain syndrome. All items were graded on a scale from 0 (good condition) to 4 (poor condition) for a total score between 0 and 32.|Baseline and 4 Weeks|Titration Completers Population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase|||units on a scale||Standard Deviation|Mean
2661518|NCT01569438|Primary|The Primary Efficacy Endpoint of This Study is Change in the 'Average Pain' NPRS Score.|Subjects were instructed to select a number on a scale that best described the severity of bladder pain during the past 24 hours. The scale was between 0 and 10 where 0 was no pain and 10 was the worst pain possible. The scale was completed by telephone (an interactive voice response system[IVRS]) every evening at bedtime.|Baseline and 4 Weeks|Titration Completers Population - defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, who titrated the dose in Week 1 of the treatment phase, and who completed the 4-week treatment phase|||units on a scale||Standard Deviation|Mean
2661519|NCT01569295|Secondary|Complete Response Rate|Complete response (CR) rate was defined as the percentage of participants who achieved a CR.|Up to 84 months|Participants in the ITT Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2661520|NCT01569295|Secondary|Overall Survival|Overall survival (OS) was defined as the interval from randomization to death from any cause. Overall survival (months) = (date of death - date of randomization + 1)/30.4375.|Up to 84 months|Participants in the ITT Analysis Set were analyzed.|||months||95% Confidence Interval|Median
2661521|NCT01569295|Secondary|Lymph Node Response Rate|Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lesions.|Up to 84 months|Participants in the ITT Analysis Set with available data were analyzed.|||percentage of particpants||95% Confidence Interval|Number
2661522|NCT01569295|Secondary|Overall Response Rate (ORR)|"ORR was the percentage of participants who achieved a complete response (CR), CR with incomplete marrow recovery (CRi,) or partial response (PR) and maintained the response for at least 12 weeks. CR was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.~PR was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors. CRi was defined as all criteria for CR met but with persistent anemia, thrombocytopenia, neutropenia or a hypocellular bone marrow."|Up to 84 months|Participants in the ITT Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2661523|NCT01569295|Primary|Progression-Free Survival (PFS)|PFS was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. PFS (months) = (minimum (date of disease progression, date of death) - date of randomization + 1)/30.4375.|Up to 84 months|The intent-to-treat (ITT) Analysis Set included all participants randomised in the study regardless of whether study drug was administered and with treatment group designated according to initial randomisation.|||months||95% Confidence Interval|Median
2661524|NCT01569191|Primary|Ocular Temperature|Ocular surface temperature will be measured with an infra-red camera|1 hour||||degrees centrigrade||Standard Deviation|Mean
2661525|NCT01569191|Primary|Ocular Redness|"Bulbar and limbal redness will be observed with a slit lamp biomicroscope and graded using a validated scale~• The 'Efron' grading scale consists of 5 pictures of eyes of increasing severity of blood vessels over the white of the eye, with the clinician selecting the image closest to what they observe on the patient (0 indicating a white eye and 4 a very irritated eye). There are no subscales"|1 hour||||units on a scale||Standard Deviation|Mean
2661526|NCT01569191|Primary|Symptoms|Short questionnaire Ocular allergy symptomology was also measured using the eye symptom section from the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) on a 0 to 6 scale, with the summed score for itching, watering, swelling and soreness resulting in a summed score between 0 and 24. A higher score indicates a worse outcome (more severe symptoms)|1 hour||||Units on a scale||Standard Deviation|Mean
2661527|NCT01569152|Secondary|Percentage of Participants With an ACR20 Response Over Time|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR20 response is defined as a ≥20% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥20% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 1, Week 2, Week 4, Week 6, Week 18 and Week 24|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline ACR20 measurement|||Percentage of participants|||Number
2661528|NCT01569152|Secondary|Percentage of Participants Achieving an ACR50 Response at Week 12|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR50 response is defined as a ≥50% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥50% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline ACR50 assessment|||Percentage of participants|||Number
2661530|NCT01569152|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 12|The ESR is the rate at which red blood cells sediment in a period of one hour, and is a non-specific measure of inflammation. Change from Baseline is ESR at Week 12 minus ESR at Baseline. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline ESR assessment|||mm/hr||95% Confidence Interval|Least Squares Mean
2661531|NCT01569152|Secondary|Change From Baseline in Serum C-Reactive Protein (CRP) at Week 12|C-Reactive Protein is an inflammatory marker with a normal reference range of less than 0.9 mg/dL. Change from Baseline in CRP at Week 12 (Week 12 concentration minus Baseline concentration). This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline serum CRP assessment|||mg/dL||95% Confidence Interval|Least Squares Mean
2661532|NCT01569152|Secondary|Change From Baseline in the Health Assessment Questionnaire Disability (HAQ Disability Index) at Week 12|The functional status of the participant was assessed using the Disability Index of the HAQ on a Likert scale. This 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area. The overall score for the Disability Index is the mean of the 8 functional area scores and also ranges from 0 to 3, with a lower score indicating less disability. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline HAQ Disability Index assessment|||Units on a scale||95% Confidence Interval|Least Squares Mean
2661533|NCT01569152|Secondary|Change From Baseline in the Patient's Global Assessment of Pain (PGAP) at Week 12|"A participant's overall assessment of pain was assessed from the amount of pain due to arthritis experienced during the past 48 hours on a VAS where 0 mm = no pain and 100 mm = extreme pain. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only."|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline PGAP assessment|||Units on a scale||95% Confidence Interval|Least Squares Mean
2661534|NCT01569152|Secondary|Change From Baseline in the Investigator's Global Assessment of Disease Status/Activity (IGADSA) at Week 12|The Investigator's Global Assessment of Disease Status/Activity (IGADSA) is measured with scores ranging from 0 to 100 mm (VAS, 0 mm = doing very well to 100 mm = doing very poor). A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline IGADSA assessment|||Units on a scale||95% Confidence Interval|Least Squares Mean
2661535|NCT01569152|Secondary|Change From Baseline in the Patient's Global Assessment of Disease Status/Activity (PGADSA) at Week 12|A participant's overall assessment of pain was assessed from the amount of pain due to arthritis experienced during the past 48 hours on a VAS, where 0 mm = doing very well to 100 mm = doing very poor. A negative change from Baseline indicates improvement. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline PGADSA assessment|||Units on a scale||95% Confidence Interval|Least Squares Mean
2661536|NCT01569152|Secondary|Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 12|The FACIT-F is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). The higher the participant's response to the questions the greater the participant's fatigue. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
2661537|NCT01569152|Secondary|Change From Baseline in the Short Form Health Survey (SF-36) at Week 12|The SF-36 is a health-related quality of life instrument that consists of 8 multi-item scales: limitations in physical functioning due to health problems, limitations in usual role activities due to physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities due to personal or emotional problems, limitations in social functioning due to physical or mental health problems, vitality (energy and fatigue), and general health perception. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. The lower the score the greater the disability i.e., a score of 0 corresponds to maximum disability and a score of 100 corresponds to no disability. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
2661538|NCT01569152|Secondary|Change From Baseline in the Simplified Disease Activity Index (SDAI) at Week 12|SDAI is the simple linear sum of the following parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, Patient's Global Assessment of Disease Activity [PGA, VAS 0 to 10 cm], Investigator's Global Assessment of Disease Activity (MDGA, VAS 0 to 10 cm) and CRP levels (mg/dL). SDAI =TJC + SJC + PGA + MDGA + CRP. Overall scores can range from 0.0 to 86.0. A higher score indicated greater disease severity. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline SDAI assessment|||Units on a scale||95% Confidence Interval|Least Squares Mean
2661687|NCT01568008|Secondary|Physician Assessment of Treatment Tolerability Using a 4-Point Scale|The Physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported.|12 weeks|All patients with data available for this outcome measure.|||Participants|||Number
2668475|NCT01505764|Secondary|Resting Energy Expenditure.|% change between day 84 and baseline|day 84|cancer cachexia patients|||percentage change||Standard Deviation|Mean
2661539|NCT01569152|Secondary|Change From Baseline in Swollen Joint Count at Week 12|Swollen joint count included 66 joints (same joints as for tender joint count except this excluded evaluation of hips) that were assessed for the presence of swelling. Soft tissue swelling was considered to be present if there was palpable or visible evidence of capsular distention considered to be due to either synovial thickening and/or a joint effusion. Bony swelling, nodule formation, and joint deformity were excluded from consideration. A swollen joint was scored as 0 = Absent; 1 = Present for each joint. The overall swollen joint count ranged from 0 to 66. A higher score indicated greater disease severity. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline swollen joint count|||Swollen joints||95% Confidence Interval|Least Squares Mean
2661540|NCT01569152|Secondary|Change From Baseline in Tender Joint Count at Week 12|Tender Joint Count was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A higher score indicated greater disease severity. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline tender joint count|||Tender joints||95% Confidence Interval|Least Squares Mean
2661541|NCT01569152|Secondary|DAS28-CRP Area Under the Curve (AUC)|DAS28-CRP AUC was to be calculated from the DAS28-CRP score versus time curve, which provided an assessment of changes in disease activity over time. The DAS28-CRP AUC was to be calculated using the trapezoidal rule as the DAS28-CRP multiplied by the duration of the assessment period (in weeks) and was to be expressed as %-weeks. A higher calculated AUC value indicates higher disease activity (worse). This outcome measure applied to Base Study participants only.|Up to 12 weeks|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
2661542|NCT01569152|Secondary|DAS28-ESR Area Under the Curve (AUC)|DAS28-ESR AUC was to be calculated from the DAS28-ESR score versus time curve, which provided an assessment of changes in disease activity over time. The DAS28-ESR AUC was to be calculated using the trapezoidal rule as the DAS28-ESR multiplied by the duration of the assessment period (in weeks) and was to be expressed as %-weeks. A higher calculated AUC value indicates higher disease activity (worse). This outcome measure applied to Base Study participants only.|Up to 12 weeks|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
2661543|NCT01569152|Secondary|Percentage of Participants Achieving DAS28-CRP Remission at Week 12|The DAS28-CRP is a continuous parameter derived from the formula: 0.56 × the square root of the tender joint count (0-28) + 0.28 × the square root of the swelling joint count (0-28) + 0.36 × the C reactive protein value (in mg/L +1) + 0.014 × Patient's Global Assessment of Disease Activity VAS of 0-100 mm + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. DAS28-CRP remission is defined as a value <2.6 at the visit. This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline DAS28-CRP measurement|||Percentage of participants|||Number
2661544|NCT01569152|Secondary|Percentage of Participants Achieving DAS28-ESR Remission at Week 12|The DAS28-ESR is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), ESR, and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-ESR = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.70 × ln (ESR) + 0.014 × GH. SQRT = square root. The DAS28-ESR is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. DAS28-ESR remission is defined as a value <2.6 at the visit. This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline DAS28-ESR measurement|||Percentage of participants|||Number
2661545|NCT01569152|Secondary|Percentage of Participants Achieving a DAS28-CRP Response at Week 12|The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), CRP, and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. Depending upon the DAS28-CRP value for a given visit, change in DAS28-CRP is categorized as follows: No Response (reduction from Baseline ≤0.6), No response or Moderate Response (reduction >0.6 - 1.2), and Moderate or Good Response (reduction >1.2). The percentage of participants with a Moderate or Good change in DAS28-CRP was reported. This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline DAS28-CRP measurement|||Percentage of participants|||Number
2661546|NCT01569152|Secondary|Percentage of Participants Achieving a DAS28-ESR Response at Week 12|The DAS28-ESR is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), ESR, and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-ESR = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.70 × ln (ESR) + 0.014 × GH. SQRT = square root. The DAS28-ESR is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. Depending upon the DAS28-ESR value for a given visit, change in DAS28-ESR is categorized as follows: No Response (reduction from Baseline ≤0.6), No response or Moderate Response (reduction >0.6 - 1.2), and Moderate or Good Response (reduction >1.2). The percentage of participants with a Moderate or Good change in DAS28-ESR was reported. This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline DAS28-ESR measurement|||Percentage of participants|||Number
2661688|NCT01568008|Secondary|Patient Assessment of Treatment Tolerability Using a 4-Point Scale|Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported.|12 weeks|All patients with data available for this outcome measure.|||Participants|||Number
2661689|NCT01567943|Secondary|Psychiatric Symptomology|Brief Symptom Inventory; Positive and Negative Symptom Scale|throughout 7 months of study|||||||
2661547|NCT01569152|Secondary|Percentage of Participants Achieving an ACR-N Response at Week 12|"The ACR-N response is the minimum of the following: 1) the percent decrease from Baseline in tender joint counts (68 joints, 0 = absent, 1 = present); 2) the percent decrease from Baseline in swollen joint counts (66 joints, 0 = absent, 1 = present); and 3) the median percent decrease from Baseline for the following: a) Patient's Global Assessment of Pain (VAS, 0 mm = no pain and 100 mm = extreme pain); b) Patient's Global Assessment of Disease Activity (VAS, 0 mm = doing very well to 100 mm = doing very poor); c) Investigator's Global Assessment of Disease Activity (VAS, 0 mm = doing very well to 100 mm = doing very poor); d. physical function as measured by the HAQ (Likert scale, 0 to 3 with a lower score indicating less disability); and e) CRP. This outcome measure applied to Base Study participants only."|Week 12|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
2661548|NCT01569152|Secondary|Percentage of Participants Achieving Hybrid ACR Response at Week 12|Hybrid ACR Response evaluates the improvement in active RA by combining elements of the ACR20/50/70 with a categorical score of the mean change in the core set measures (tender joint count, swollen joint count, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, disability index of the HAQ, and CRP). The mean percentage improvement from Baseline in the core set measures was computed and used with the participant's ACR20, ACR50, and ACR70 status to determine the hybrid ACR response in a lookup table. The range of values was -100 to 100, with a positive change indicating improvement. This outcome measure applied to Base Study participants only.|Week 12|Due to the early termination of the study, analysis for this outcome measure was not performed according to the protocol because complete data were not available.||||||
2661549|NCT01569152|Secondary|Percentage of Participants Achieving an ACR70 Response at Week 12|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR70 response is defined as a ≥70% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥70% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline ACR70 measurement|||Percentage of participants|||Number
2661550|NCT01569152|Secondary|Change From Baseline in DAS28 as Measured by C-Reactive Protein (CRP) at Week 12|The DAS28-CRP is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), CRP (an inflammatory marker), and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-CRP = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.36 × ln (CRP+1) + 0.014 × GH + 0.96. The DAS28-CRP is a scale ranging from 0 to 10 with higher values indicating greater RA disease activity. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had both Baseline and Week 12 DAS28-CRP measurements|||Units on a scale||95% Confidence Interval|Least Squares Mean
2661551|NCT01569152|Secondary|Change From Baseline in Disease Activity Score (DAS28) as Measured by Erythrocyte Sedimentation Rate (ESR) at Week 12|The DAS28-ESR is a continuous parameter based upon a statistically-derived index combining tender joints (28 joints, TEN28), swollen joints (28 joints, SW28), ESR (an inflammatory marker), and Patient's Global Assessment of Disease Activity VAS (GH). It is defined as follows: DAS28-ESR = 0.56 × SQRT(TEN28) + 0.28 × SQRT(SW28) + 0.70 × ln (ESR) + 0.014 × GH. SQRT = square root. The DAS28-ESR is a scale ranging from 0 to 10 with higher values indicating greater rheumatoid arthritis (RA) disease activity. This outcome measure applied to Base Study participants only.|Baseline and Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had both Baseline and Week 12 DAS28-ESR measurements|||Units on a scale||95% Confidence Interval|Least Squares Mean
2661552|NCT01569152|Primary|Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12|ACR responses are numerical measurements of improvement in multiple disease assessment criteria. An ACR20 response is defined as a ≥20% improvement in 1) swollen joint count (66 joints) and tender joint count (68 joints) (0 = Absent; 1 = Present) and 2) ≥20% improvement in 3 of the following 5 assessments: a) a participant's overall assessment of pain on a visual analog scale (VAS, no pain =0 to extreme pain =100); b) Patient's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100); c) Investigator's Global Assessment of Disease Activity VAS (doing very well =0 to doing very poor =100 ; d) participant's assessment of function across 8 functional areas as measured by Health Assessment Questionnaire (HAQ), total scores ranging from no difficulty =0 to inability to perform tasks =24; and e) serum C-Reactive Protein (decrease indicates improvement). This outcome measure applied to Base Study participants only.|Week 12|Randomized participants in Base Study Phase IIa who received at least one dose of study drug and had at least one post-baseline ACR20 measurement (last observation carried forward)|||Percentage of participants|||Number
2661553|NCT01569126|Secondary|Change From Baseline in Bazett's and Fridericia's Corrected QT (QTcB and QTcF) Intervals|The number of participants with a maximum increase from baseline in 12-lead electrocardiogram (ECG) QTcB and QTcF intervals >30 milliseconds (ms) and >60 ms for the single-dose (SD) and multiple-dose (MD) periods is reported.|Baseline, up to Day 43 (SD period) and Baseline, up to Day 70 (MD period)|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||participants|||Number
2661554|NCT01569126|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Multiple Doses (MD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(tau,steady state) of plasma total fluoxetine and norfluoxetine during the MD period is reported.|Predose up to Day 28|Randomized participants, in Cohorts 4 and 5, who received at least 1 dose of study drug (excluding placebo) and had evaluable pharmacokinetic data.|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2661555|NCT01569126|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to 24 Hours [AUC(0-24)] of Multiple Doses (MD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(0-24) of plasma total fluoxetine and norfluoxetine on Day 1 of the MD period is reported.|Day 1|Randomized participants, in Cohorts 4 and 5, who received at least 1 dose of study drug (excluding placebo) and had evaluable pharmacokinetic data.|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2661556|NCT01569126|Secondary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Multiple Doses (MD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The Cmax of plasma total fluoxetine and norfluoxetine on Day 1 and Day 28 of the MD period is reported.|Days 1 and 28|Randomized participants, in Cohorts 4 and 5, who received at least 1 dose of study drug (excluding placebo) and had evaluable pharmacokinetic data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2661557|NCT01569126|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-infinity)] of Single Dose (SD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(0-infinity) of plasma total fluoxetine and norfluoxetine during the SD period is reported.|Predose up to Day 43|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had evaluable pharmacokinetic data.|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2661558|NCT01569126|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve From Zero to Last Time Point [AUC(0-tlast)] of Single Dose (SD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The AUC(0-tlast) of plasma total fluoxetine and norfluoxetine during the SD period is reported.|Predose up to Day 43|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had evaluable pharmacokinetic data.|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2661559|NCT01569126|Secondary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Single Dose (SD) of LY110140|Study drug was administered as LY110140 (fluoxetine hydrochloride) and its active portion, fluoxetine, was metabolized to norfluoxetine in the body. The Cmax of plasma total fluoxetine and norfluoxetine during the SD period is reported.|Predose up to Day 43|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had evaluable pharmacokinetic data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2661560|NCT01569126|Primary|Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Multiple-Dose (MD) Period|A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to Day 70|Randomized participants, in Cohorts 4 and 5, who received at least 1 dose of study drug or placebo and had at least 1 postdose safety assessment.|||participants|||Number
2661561|NCT01569126|Primary|Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs During the Single-Dose (SD) Period|A drug-related AE was an AE that occurred postdose or was present predose and became more severe postdose and was considered to be related to study treatment. A summary of AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to Day 43|Randomized participants, in Cohorts 1, 2, and 3, who received at least 1 dose of study drug and had at least 1 postdose safety assessment.|||participants|||Number
2661562|NCT01569087|Secondary|Incidence of Febrile Neutropenia||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)|||participants|||Number
2661563|NCT01569087|Secondary|Duration of Neutropenia From Nadir to ANC < 2,0 x 10^9 Cells/L on the First Cycle of Chemotherapy||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)|||days||Standard Deviation|Mean
2661564|NCT01569087|Secondary|Low Level (Nadir) ANC x 10^9/L||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)|||cells x 10^9/L||Inter-Quartile Range|Median
2661565|NCT01569087|Secondary|The Duration of Any Grade Neutropenia||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)|||days||Standard Deviation|Mean
2661566|NCT01569087|Secondary|Mean Duration of CTCAE Grade 4 Neutropenia||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)|||days||Standard Deviation|Mean
2661567|NCT01569087|Primary|CTCAE Grade 3/4 Neutropenia Incidence||21 days|Modified intention-to-treat population (analysis included patients who received at least 1 injection of study drug. Patients who had missed blood sampling on visit 5 [expected time of nadir] were excluded from analysis)|||participants|||Number
2661576|NCT01569074|Secondary|Proportion of Patients Achieving ACR20 at Week 1, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally.|1 week|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle. The fostamatinib 100 mg BID combined group contains 31 patients from Dosing Group A and 33 patients from Dosing Group B.|||Percentage of responders|||Number
2661690|NCT01567943|Secondary|Community Outcomes|(jail bookings, ER visits, mental health and substance abuse service utilization)|entire study period, and three month prior and after study involvement|||||||
2661568|NCT01569074|Secondary|SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 12|SF-36 = 36-item Short Form Health Survey, as a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50, standard deviation of 10. A higher score represents better quality of life. Mean changes from baseline are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in scores at Week 12. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|Baseline and 12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
2661569|NCT01569074|Secondary|SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 12|SF-36 = 36-item Short Form Health Survey, as a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0 to 100. The physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50, standard deviation of 10. A higher score represents better quality of life. Mean changes from baseline are presented as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. Mean refers to change in scores at Week 12. ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|Baseline and 12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Units on a scale||Standard Deviation|Mean
2661570|NCT01569074|Secondary|Proportion of Patients With HAQ-DI Response at Week 12, Comparison Between Fostamatinib and Placebo|HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with higher score indicating greater disability. HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2661571|NCT01569074|Secondary|Proportion of Patients With DAS28-CRP EULAR Response at Week 12, Comparison Between Fostamatinib and Placebo|Change from baseline in DAS28-CRP at Week 12 was derived and categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice a day, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2661572|NCT01569074|Secondary|Proportion of Patients Achieving DAS28-CRP<=3.2 at Week 12, Comparison Between Fostamatinib and Placebo|DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. DAS28-CRP score of <=3.2 indicates low disease activity. BID = twice daily, CRP = C-reactive protein, , DMARD = disease modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once daily.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2661573|NCT01569074|Secondary|ACRn - Comparison Between Fostamatinib and Placebo at Week 12|ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as C-Reactive Protein) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. Mean refers to change at Week 12. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|Baseline and 12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage improvement from baseline||Standard Deviation|Mean
2661574|NCT01569074|Secondary|Proportion of Patients Achieving ACR70 at Week 12, Comparison Between Fostamatinib and Placebo|ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2661575|NCT01569074|Secondary|Proportion of Patients Achieving ACR50 at Week 12, Comparison Between Fostamatinib and Placebo|ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2661577|NCT01569074|Primary|Proportion of Patients Achieving ACR20 at Week 12, Comparison Between Fostamatinib and Placebo|ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as C-Reactive Protein) and the physician and patient's own assessments of disease activity, pain and physical function. BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.|12 weeks|The full analysis set includes those patients who received at least 1 dose of investigational product. Patients were analysed by randomised treatment in accordance with the intention to treat principle.|||Percentage of responders|||Number
2661578|NCT01569022|Secondary|Adherence to Therapy|comparison of the number of hours per night used while on CPAP versus MAD|12 weeks||||hours per night||Standard Deviation|Mean
2661579|NCT01569022|Secondary|General Health SF-36|The SF-36 is a generic 36-item Short Form Medical Outcomes Survey (SF-36) 16. It has eight main domains: physical functioning, role limitation due to physical problems, role limitation due to emotional problems, social functioning, mental health, energy/vitality, bodily pain, and general health perception. General Health SF36 score is coded, summed, and transformed onto a scale from 0 to 100 (worst to best possible health).|12 weeks||||units on a scale||Standard Deviation|Mean
2661580|NCT01569022|Secondary|Health Outcomes|"Health outcomes including ESS, PCL-M, and PSQI. ESS is a short questionnaire validated to measure excessive daytime sleepiness in patients with OSA 17. It measures the likelihood of falling asleep in eight different situations, with a score of 0-3 for each situation. The sum of individual scores for the eight items gives the final ESS score, ranging from 0-21. An ESS score >10 suggests excessive daytime sleepiness (EDS). The PSQI is a self-rating questionnaire that consists of seven dimensions. The possible scores range from 0-21, with greater than five indicative of impaired sleep quality. The PTSD Checklist is a 17-item self-report measure (1-5 points each) that assesses PTSD symptoms in relation to stressful military experiences. PTSD symptom severity scores are determined by summing the participants' answers to all 17 items from 1 (not at all) to 5 (extremely)(range 17-85) 14 with 5-10 point change indicating statistically significant response to treatment"|12 weeks||||units on a scale||Standard Deviation|Mean
2661581|NCT01569022|Primary|Residual Apnea Hypopnea Index|The primary endpoint of the study was tested by comparing the upper limit of the 95% confidence interval for the CPAP-MAD difference in residual AHI with the a priori noninferiority margin using the paired t test|up to 12 weeks||||events per hour||Standard Deviation|Mean
2661582|NCT01568905|Secondary|Comparison of Number of Cigarettes Smoked|Subjects were given a daily diary to collect the number of study and/or conventional cigarettes they have smoked each day. Cigarettes smoked (both usual brand and experimental) in a given week were summed over the first 7 reported days. If the number of cigarettes smoked was missing for 1 day, the average of the other days in that week was used in its place and reported as total number of cigarettes per week.|1 week||||cigarettes per week||Standard Deviation|Mean
2661583|NCT01568905|Secondary|Change From Baseline of Perceived Health Risk Scale Response to Test Cigarettes|Questionnaire: Perceived Health Risk Scale asks subjects to rate their perception of health risks for lung cancer for the study product to which they have been randomly assigned. This is a 100 mm visual analog scale; 0=very low risk of disease, 100=very high risk of disease.|Baseline (Day 1) Compared to Second Visit (Week 1)||||units on a scale||Standard Error|Mean
2661584|NCT01568905|Secondary|Responses on Modified Cigarette Evaluation Scale|Modified Cigarette Evaluation Scale [CES] is a 100 mm visual analog scale (0=not at all or very little nicotine; 100=extremely or high in nicotine) of 20 questions assessing different dimensions of responses to usual brand cigarettes (e.g., psychological reward, satisfaction and aversiveness) and includes additional 5 point likert-type questions (definitely agree to definitely disagree) on perceptions of satisfaction and willingness to use the product. Results satisfaction subscale.|Baseline usual brand cigarettes (Day 1) compared to when using study cigarettes (Week 1)||||units on a scale||Standard Error|Mean
2661585|NCT01568905|Primary|Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1|Two urine TNE levels are taken, one at baseline and one at week 1, to assess TNE levels for nicotine exposure. TNE is the sum of nicotine, cotinine, trans 3'-hydroxycotinine and their respective glucuronide conjugates. Values reported in nmols/ml.|Second Visit (Week 1) minus Baseline (Day 1)||||nmols/ml||Standard Error|Mean
2661586|NCT01568892|Secondary|Change From Baseline in Red Blood Cell Count|Blood samples were collected for the analysis of hematology parameters such as RBC. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)|||Trillion cells per liter||Standard Deviation|Mean
2661587|NCT01568892|Secondary|Change From Baseline in Mean Corpuscle Volume|Blood samples were collected for the analysis of hematology parameters such as mean corpuscle volume. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)|||Femtoliter||Standard Deviation|Mean
2661588|NCT01568892|Secondary|Change From Baseline in Hematocrit Level|Blood samples were collected for the analysis of hematology parameters such as hematocrit level. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)|||Proportion of red blood cells in blood||Standard Deviation|Mean
2661589|NCT01568892|Secondary|Change From Baseline in Hemoglobin Level|Blood samples were collected for the analysis of hematology parameters such as hemoglobin. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|||Grams per liter||Standard Deviation|Mean
2661691|NCT01567943|Secondary|Other Drug Use as Measured by Urinalysis||through 7 months of study|||||||
2661590|NCT01568892|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count|Blood samples were collected for the analysis of hematology parameters such as basophils, eosinophils. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)|||Giga cells per liter||Standard Deviation|Mean
2661591|NCT01568892|Secondary|Change From Baseline in Lipase Levels|Blood samples were collected for the analysis of clinical chemistry parameters such as lipase level. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|||Units per liter||Standard Deviation|Mean
2661592|NCT01568892|Secondary|Change From Baseline in Creatinine Clearance|Creatinine clearance was calculated using Cockcroft-Gault formula. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline, Day 8, Day 28, Week 8, Week 16, Week 24, Week 32 and Week 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)|||Milliliters per minute||Standard Deviation|Mean
2661593|NCT01568892|Secondary|Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen|Blood samples were collected for the analysis of clinical chemistry parameters such as cholesterol, chloride, CO2/HCO3, glucose, high density lipoprotein (HDL) cholesterol, potassium, LDL cholesterol, sodium, phosphorus inorganic, triglycerides and urea/blood urea nitrogen (BUN). Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|Safety Population. Lipid and glucose parameters were only summarized on fasting data. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)|||Millimoles per liter||Standard Deviation|Mean
2661594|NCT01568892|Secondary|Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels|Blood samples were collected for the analysis of clinical chemistry parameters such as T. Bil and creatinine. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)|||Micromoles per liter||Standard Deviation|Mean
2661595|NCT01568892|Secondary|Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase|Blood samples were collected for the analysis of clinical chemistry parameters such as ALP, ALT, AST and creatine kinase. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|||International units per liter||Standard Deviation|Mean
2661596|NCT01568892|Secondary|Change From Baseline in Albumin Level|Blood samples were collected for the analysis of clinical chemistry parameters such as albumin. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline, Week 24 and 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|||grams per liter||Standard Deviation|Mean
2661597|NCT01568892|Secondary|Change From Baseline in Heart Rate|Vital signs including heart rate was measured at Baseline, Week 24 and Week 48. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline and Weeks 24 and 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|||beats per minute||Standard Deviation|Mean
2661598|NCT01568892|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital signs including SBP and DBP were measured at Baseline, Week 24 and Week 48. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline and Weeks 24 and 48|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|||millimeters of mercury||Standard Deviation|Mean
2661599|NCT01568892|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings|Twelve lead ECG was performed using an automated ECG machine. The number of participants with abnormal-clinically significant ECG findings at any time on-treatment is reported.|Up to Week 24|Safety Population. Only those participants with data available at the specified time point was analyzed.|||Participants|||Count of Participants
2661600|NCT01568892|Secondary|Number of Participants Who Discontinued Study Treatment Due to AEs|The number of participants who permanently discontinued study treatment due to AEs is presented.|From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)|Safety Population|||Participants|||Count of Participants
2661616|NCT01568892|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA Over Time|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, and Week 84. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.|Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84|ITT-E Population. The Observed Case dataset, in which only the data that are available at the particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Log10 c/mL||Standard Deviation|Mean
2661601|NCT01568892|Secondary|Number of Participants With the Indicated Fold Increase in Fold Change (FC) in the 50% Inhibitory Concentration Relative to Wild-type Virus for DTG (i.e. PDVF FC/Baseline FC Ratio) at the Time of PDVF, as a Measure of Phenotypic Resistance|For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.|From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)|PDVF Genotypic/Phenotypic Population: all participants in the ITT-E population with protocol-defined virologic failure. Only participants with Baseline integrase mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.|||Participants|||Count of Participants
2661602|NCT01568892|Secondary|Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance|For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline.|From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)|PDVF Genotypic/Phenotypic Population: all participants in the ITT-E population with protocol-defined virologic failure. Only participants with Baseline integrase mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.|||Participants|||Count of Participants
2661603|NCT01568892|Secondary|Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24|Blood samples for the determination of plasma DTG pre-dose concentration were collected pre-dose on Day 8, Day 28, and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed. C0 Avg was calculated at Week 24 as the mean of the concentration at Day 8, Day 28, and Week 24.|Day 8, Day 28, and Week 24|PK Parameter Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Parameter Population.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2661604|NCT01568892|Secondary|Cmax of DTG|The maximal concentration (Cmax) of DTG was assessed by a population PK modeling approach using pooled DTG PK data from multiple studies. Blood samples for the determination of plasma DTG concentration were collected at the following time points: pre-dose and 1-3 hours post-dose on Day 8; pre-dose and within a post-dose window (1-3 hours or 4-12 hours) on Day 28 and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed.|Day 8, Day 28, and Week 24|PK concentration Population comprised of all participants who received DTG, underwent PK sampling during the study, and provided evaluable DTG plasma concentration data.|||Micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2661605|NCT01568892|Secondary|AUC(0-tau) of DTG|The area under the time concentration curve over the dosing interval (AUC[0-tau]) of DTG was assessed by a population pharmacokinetic (PK) modeling approach using pooled DTG PK data from multiple studies. Blood samples for the determination of plasma DTG concentration were collected at the following time points: pre-dose and 1-3 hours post-dose on Day 8; pre-dose and within a post-dose window (1-3 hours or 4-12 hours) on Day 28 and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed.|Day 8, Day 28, and Week 24|PK concentration Population comprised of all participants who received DTG, underwent PK sampling during the study, and provided evaluable DTG plasma concentration data.|||µg*hour per mL (µg*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2661606|NCT01568892|Secondary|Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade|Participants with post-Baseline-emergent hematology toxicities were analyzed. Hematology toxicities were graded for severity according to the DAIDS toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).|From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)|Safety Population|||Participants|||Count of Participants
2661607|NCT01568892|Secondary|Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade|Participants with post-Baseline-emergent clinical chemistry toxicities were analyzed. Clinical chemistry toxicities were graded for severity according to the DAIDS toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).|From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)|Safety Population|||Participants|||Count of Participants
2661617|NCT01568892|Secondary|Absolute Values in Plasma HIV-1 RNA Over Time|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, and Week 84. NA indicates data was not available.|Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Log10 c/mL||Standard Deviation|Mean
2661692|NCT01567943|Secondary|Self Report Drug Use||through 7 months of study|||||||
2661608|NCT01568892|Secondary|Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity; or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in other situations. Adverse events were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).|From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)|Safety Population: all randomized participants who received at least one dose of study medication|||Participants|||Count of Participants
2661609|NCT01568892|Secondary|Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])|The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|From the day of the first dose of study drug until early withdrawal or the Week 48 analysis cut-off date (median of 55 study weeks)|ITT-E Population|||Participants|||Count of Participants
2661610|NCT01568892|Secondary|Median Change From Baseline in CD8+ Cell Counts Over Time|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 28; and Weeks 12, 24, and 48. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline; Day 28; Weeks 12, 24, and 48|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Cells per cubic millimeter||Inter-Quartile Range|Median
2661611|NCT01568892|Secondary|Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts Over Time|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 28; and Weeks 12, 24, and 48.|Baseline; Day 28; Weeks 12, 24, and 48|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Cells per cubic millimeter||Inter-Quartile Range|Median
2661612|NCT01568892|Secondary|Median Change From Baseline in CD4+ Cell Counts Over Time|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.|Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84|ITT-E Population. Observed dataset was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Cells per cubic millimeters||Inter-Quartile Range|Median
2661613|NCT01568892|Secondary|Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time|Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84.|Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84|ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).|||Cells per cubic millimeters||Inter-Quartile Range|Median
2661614|NCT01568892|Secondary|Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1); Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48. Number of participants with plasma HIV-1 RNA level <400 c/mL was obtained using FDA's snapshot algorithm, where all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) were treated as non-responders. Also, participants who switch their concomitant ART prior to the visit of interest as follows were also treated as non-responders: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol; however the decision to switch is not documented as being before or at the first On-treatment visit after switching to OBR (i.e. Day 28) where HIV-1 RNA is assessed.|Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48|ITT-E Population. The Snapshot dataset was used for analysis.|||Participants|||Count of Participants
2661615|NCT01568892|Secondary|Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1); Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, and 48. Number of participants with plasma HIV-1 RNA level <50 c/mL was obtained using Food and Drug Administration's (FDA's) snapshot algorithm, where all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) were treated as non-responders. Also, participants who switched their concomitant antiretroviral therapy (ART) prior to the visit of interest as follows were also treated as non-responders: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol; however, the decision to switch is not documented as being before or at the first On-treatment visit after switching to optimized background regimen (OBR) (i.e. Day 28) where HIV-1 RNA is assessed.|Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48|ITT-E Population. The Snapshot dataset was used for analysis.|||Participants|||Count of Participants
2661693|NCT01567943|Secondary|Change in Intensive Outpatient Substance Abuse Treatment Attendance||During 16 weeks of treatment||||percentage of addiction tx attended||Standard Deviation|Mean
2661618|NCT01568892|Primary|Mean Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at Day 8|Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1) and Day 8. Change from Baseline was calculated as the value at Day 8 minus the value at Baseline (Day 1). The analysis was performed using statistical modeling correcting for Baseline plasma HIV-1 RNA, Baseline Dolutegravir (DTG) fold change (FC), the overall susceptibility score (OSS) of the failing regimen, and the interaction between DTG FC and treatment. Means and differences were calculated using the average Baseline DTG FC of the entire Intent-to-Treat Exposed (ITT-E) Population. The last observation carried forward with discontinuation equals Baseline (LOCFDB) dataset was used for the analysis. For the LOCFDB dataset, missing values were carried forward from the previous, non-missing, available on-treatment assessment, except formissing values due to premature withdrawal or Day 8 missing values, which had the Baseline value imputed.|Baseline and Day 8|ITT-E Population: all randomized participants who received at least one dose of study medication. One participant receiving DTG 50 mg BID was excluded from analysis because they had no Baseline DTG FC value.|||Log 10 copies per milliliter (c/mL)||Standard Error|Least Squares Mean
2661619|NCT01568866|Secondary|Change From Baseline in Pulmonary Artery Systolic Pressure (PASP)|Pulmonary artery pressure was measured using transthoracic echocardiogram.|Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).|"Cardiopulmonary Safety Evaluable subgroup with available PASP data at baseline; n indicates participants whose results were available at both the baseline and the specified post-baseline visit."|||mmHg||Standard Deviation|Mean
2661620|NCT01568866|Secondary|Change From Baseline in Right Ventricular Fractional Area Change (FAC)|Right ventricular function was assessed by measuring fractional area change (FAC) on echocardiogram.|Baseline and Weeks 12, 24 and 36 and at end of treatment (median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group).|"Cardiopulmonary Safety Evaluable subgroup with available FAC data at baseline; n indicates participants whose results were available at both the baseline and the specified post-baseline visit."|||percent fractional area change||Standard Deviation|Mean
2661621|NCT01568866|Secondary|Percentage of Participants With a Significant Reduction in Left Ventricular Ejection Fraction (LVEF)|"A significant reduction in LVEF was defined as a ≥ 10% decrease (absolute change) from baseline in participants whose baseline LVEF is ≤ 55%.~For participants with LVEF > 55% at baseline, a significant change was defined as a decrease in LVEF to < 45%."|Baseline and 24 weeks|Cardiopulmonary Safety Evaluable subgroup (all randomized participants who enrolled in the cardiopulmonary substudy with evaluable baseline echocardiogram scans per the central laboratory) and with both baseline and at least one post-baseline LVEF measurement within 24 weeks.|||percentage of participants|||Number
2661622|NCT01568866|Secondary|Percentage of Participants With ≥ Grade 2 Peripheral Neuropathy|"Neuropathy events were defined as Grade 2 or higher peripheral neuropathy as specified by peripheral neuropathy Standardised Medical Dictionary for Regulatory Activities (MedDRA) Query, narrow (scope) (SMQN) terms.~Peripheral neuropathy was assessed by neurologic exam and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03:~Grade 1: Asymptomatic; Grade 2: Moderate symptoms, limiting instrumental activities of daily living (ADL) Grade 3: Severe symptoms; limiting self-care ADL; Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death."|From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.|Safety population (all participants who received at least 1 dose of study treatment)|||percentage of participants||95% Confidence Interval|Number
2661623|NCT01568866|Secondary|Duration of Response|Duration of response (DOR) was calculated for participants who achieved an sCR, CR, VGPR, or PR. Duration of response is defined as the time from first evidence of PR or better to confirmation of disease progression or death due to any cause. Median duration of response was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored.|From randomization until the data cut-off date of 10 November 2014; median follow-up time for DOR was 9.4 and 10.4 months for each treatment group respectively.|Intent-to-treat population with an overall response|||months||95% Confidence Interval|Median
2661624|NCT01568866|Secondary|Overall Response|"Disease response was evaluated according to the IMWG-URC by the IRC. Overall response was defined as the percentage of participants with a best overall response of partial response (PR), very good PR (VGPR), complete response (CR) or stringent CR (sCR).~sCR: As for CR, normal serum free light chain (SFLC) ratio and no clonal cells in bone marrow (BM).~CR: No immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasma cells in BM biopsy; VGPR: Serum and urine M-protein detectable by immunofixation but not electrophoresis or ≥ 90% reduction in serum M-protein with urine M-protein <100 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline.~PR: ≥ 50% reduction of serum M-protein and reduction in urine M-protein by ≥ 90% or to < 200 mg/24 hours. A ≥ 50% reduction in the size of soft tissue plasmacytomas if present at baseline."|Disease response was assessed every 28 days until end of treatment or the data cut-off date of 10 November 2014; median duration of treatment was 27 weeks in the bortezomib group and 40 weeks in the carfilzomib treatment group.|Intent-to-treat population|||percentage of participants||95% Confidence Interval|Number
2661625|NCT01568866|Secondary|Overall Survival|"Overall survival (OS) is defined as the time from randomization to the date of death (whatever the cause). Participants who were alive or lost to follow-up as of the data analysis cut-off date were censored at the patient's date of last contact (last known to be alive).~Median overall survival was estimated using the Kaplan-Meier method."|From randomization until the data cut-off date of 03 January 2017; median follow-up time for OS was 36.9 and 37.5 months for each treatment group respectively.|Intent-to-treat population|||months||95% Confidence Interval|Median
2661640|NCT01568424|Secondary|Central Venous Pressure (CVP)|CVP is a measure of right heart filling pressure, or the preload to the right ventricle. During RVAD support, the CVP decreases as blood is drawn into the pump and then ejected into the pulmonary artery.|Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal|Patients with continuous RVAD support.|||mmHg||Full Range|Median
2661626|NCT01568866|Primary|Progression-free Survival|"Progression-free survival (PFS) was defined as the time from randomization to the earlier of disease progression or death due to any cause. Participants were evaluated for disease response and progression according to the International Myeloma Working Group-Uniform Response Criteria (IMWG-URC) as assessed by an Independent Review Committee (IRC).~Median PFS was estimated using the Kaplan-Meier method. Participants with no baseline disease assessments, starting a new anticancer therapy before documentation of disease progression or death, death or disease progression immediately after more than 1 consecutively missed disease assessment visit, or alive without documentation of disease progression before the data cut-off date were censored."|From randomization until the data cut-off date of 10 November 2014; median follow-up time for PFS was 11.1.and 11.9 months in the bortezomib and carfilzomib arms respectively|Intent-to-treat population|||months||95% Confidence Interval|Median
2661627|NCT01568827|Primary|Serum IL-6|Area Under the time-concentration Curve (AUC) of IL-6|acute (0-12 hours) after inflammation-causing challenge meal||||(pg*hr)/mL||95% Confidence Interval|Mean
2661628|NCT01568606|Primary|Number of Participants With Arrhythmia as Detected by ICD|Subjects with HF and ICD had their ICD interrogated and continually monitored by an electrophysiologist before, during, and after 30-50 seconds of bioimpedance analysis, which involves standing on the InBody 520 scale. Outcome measure was assessed during a one day visit. There is no further follow-up.|1 day, on day of study ICD interrogated and continually monitored before, during, and after 30-50 seconds of bioimpedance analysis||||participants|||Number
2661629|NCT01568593|Primary|Global Ocular Staining (With Oxford Scale - Ranges :0-15)|Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)|Baseline and 35 days|Per Protocol Population|||scores on a scale||Standard Deviation|Mean
2661630|NCT01568528|Primary|Facial Emotion Identification Task|The stimuli are 19 standard black and white pictures of faces showing one of six different emotions (happy, sad, angry, surprise, disgusted, ashamed) that were developed by Ekman and Friesen (1976). The pictures are shown for 15 sec, with 10 sec between each face. After the presentation of each face the subject is asked to choose which of the six emotions was displayed. The score on the test is the sum of correct responses. Subjects in the two groups (oxytocin vs. placebo) will be compared.|Day 1|The analysis includes participants for which valid measurements are available: 16 participants in the Healthy Control Group, 11 in the Oxytocin Group and 9 in the Placebo Group.|||Correct responses||Standard Deviation|Mean
2661631|NCT01568528|Primary|Non-Social Reward Ball-tossing Game|Social reward trials will be interleaved with non-social trials where subjects will play with random geometric shapes or landscape scenes associated with positive and negative non-social rewards. The outcome measure reported herein is the number of ball tosses the subject sends to shape A minus the number of ball tosses sent to shape B.|Day 1|The analysis includes participants for which valid measurements are available: 16 participants in the Healthy Control Group, 11 in the Oxytocin Group and 9 in the Placebo Group.|||number of ball tosses||Standard Deviation|Mean
2661632|NCT01568528|Primary|Social Reward Ball-tossing Task|Subjects will perform a computerized Social Reward Ball-Tossing Task in which they decide to return the ball to one of three fictional partners. The photos of the partners and their reciprocity in returning the ball to the subject will be manipulated. The number of balls sent to each of the partners will be quantified to assess socially reinforced learning. The result is expressed in number of ball tosses sent to the subject by a fictional player with a positive expression MINUS the number of ball tosses sent to the subject by a fictional player with a negative expression. These measures will be compared between the control subjects, oxytocin and placebo group.|Day 1|The analysis includes participants for which valid measurements are available: 16 participants in the Healthy Control Group, 11 in the Oxytocin Group and 9 in the Placebo Group.|||Number of Ball tosses||Standard Deviation|Mean
2661633|NCT01568528|Primary|Eye Tracking: Dwell Duration Time|Refers to the amount of time that an individual spent looking at the face of the stimulus presented to the participant during the eye-tracking assessment.|Day 1|The analysis includes participants for which valid measurements are available: 16 participants in the Healthy Control Group, 11 in the Oxytocin Group and 9 in the Placebo Group.|||milliseconds||Standard Deviation|Mean
2661634|NCT01568528|Primary|Eye Tracking: Fixation Count|In order to assess the processing of social stimuli, subjects will be presented with a series of human faces of mixed sex and race showing neutral emotions and instructed to visually scan each face. Six regions of interest (ROIs) will be defined for each face stimulus: eyes, nose mouth, forehead, cheeks, and outside the contours of the face. The data will be processed off line for each face stimulus as the total time of fixation inside each of the ROIs. Refers to the number of fixations that occurred on the face of the stimulus presented to the participant during the eye-tracking assessment.|Day 1|The analysis includes participants for which valid measurements are available: 16 participants in the Healthy Control Group, 11 in the Oxytocin Group and 9 in the Placebo Group.|||Number of face fixations||Standard Deviation|Mean
2661635|NCT01568424|Secondary|Total Bilirubin|Total bilirubin is a measure of hepatic function|Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removal|Patients with continuous RVAD support|||mg/dl||Full Range|Median
2661636|NCT01568424|Secondary|Creatinine|Creatinine is a measure of renal function|Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removal|Patients with continuous RVAD support|||mg/dl||Full Range|Median
2661637|NCT01568424|Secondary|Blood Urea Nitrogen (BUN)|BUN is a measure of renal function|Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal, 30 days after RVAD removal|Patients with continuous RVAD support|||mg/dl||Full Range|Median
2661638|NCT01568424|Secondary|Cardiac Index (CI)|Cardiac output (L/min) divided by the body surface area (m2)|Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal.|Patients with continuous RVAD support|||L/min/m2||Full Range|Median
2661639|NCT01568424|Secondary|Mean Arterial Pressure (MAP)|MAP is the mean value for the blood pressure in the arterial circulation. During RVAD support, this value provides information regarding the adequacy of cardiac output from the left ventricle.|Baseline, Day 1, Day 2, Day 3, Week 1, Prior to Explant, 1 day after RVAD removal, 2 days after RVAD removal.|Patients with continuous RVAD support.|||mmHg||Full Range|Median
2661642|NCT01568112|Secondary|Duration of Acute GI Episodes During Weeks 5 to 8 (Combined), Based on MAGISS|Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.|Week 5 to Week 8|Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.|||hours||Standard Deviation|Mean
2661643|NCT01568112|Secondary|Duration of Acute GI Episodes During Weeks 1 to 4 (Combined), Based on MAGISS|Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.|Week 1 to Week 4|Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.|||hours||Standard Deviation|Mean
2661644|NCT01568112|Secondary|Duration of Acute GI Episodes During the Overall Treatment Period, Based on MAGISS|Duration is calculated as follows: [(GI side effect) end date/time - (GI side effect) start date/time]/3600. For GI side effects with no end date, the end date is imputed using the last diary date/time. For subjects with more than 1 GI episode during a visit interval, the average duration for the study visit interval is used. The average duration is calculated as the total duration of the GI side effect / the total number of GI side effects.|Day 1 to Week 8|Participants in the safety population who have at least 1 diary entry of the relevant questionnaire data during the visit interval; n=number of participants with the given GI episode during the visit interval.|||hours||Standard Deviation|Mean
2661645|NCT01568112|Secondary|Duration of Flushing Events During the Weeks 5 to 8 (Combined), Based on MFSS|For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.|Week 5 to Week 8|Participants with a flushing event.|||minutes||Standard Deviation|Mean
2661646|NCT01568112|Secondary|Duration of Flushing Events During the Weeks 1 to 4 (Combined), Based on MFSS|For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.|Week 1 to Week 4|Participants with a flushing event.|||minutes||Standard Deviation|Mean
2661647|NCT01568112|Secondary|Duration of Flushing Events During the Overall Treatment Period, Based on MFSS|For participants with more than 1 flushing episode during a visit interval, the average duration for the visit interval was used. The average duration is calculated as: the total duration of all flushing episodes / the total number of flushing episodes.|Day 1 to Week 8|Participants with a flushing event.|||minutes||Standard Deviation|Mean
2661648|NCT01568112|Secondary|Number of Participants With Shifts From Baseline in Electrocardiogram (ECG) Results|Shift to 'abnormal, not adverse event' includes unknown or normal to 'abnormal, not adverse event.' Shift to 'abnormal, adverse event' includes unknown or normal to 'abnormal, adverse event.'|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not abnormal and who had at least 1 post-baseline value.|||participants|||Number
2661649|NCT01568112|Secondary|Number of Participants With Abnormalities in Vital Signs|↑=increase; ↓=decrease; BL=baseline; bpm=beats per minute; SBP=systolic blood pressure; DBP=diastolic blood pressure; b/m=breaths per minute|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants who had a baseline value and had at least 1 post-baseline value.|||participants|||Number
2661650|NCT01568112|Secondary|Clinical Laboratory Shifts From Baseline in Reported Values: Urinalysis|Number of participants with clinical laboratory shifts from baseline in urinalysis values.Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. Shift to positive includes negative to positive and unknown to positive. RBC=red blood cells, WBC=white blood cells.|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high or positive) and who had at least 1 post-baseline value.|||participants|||Number
2661651|NCT01568112|Secondary|Clinical Laboratory Shifts From Baseline in Reported Values: Blood Chemistry|Number of participants with clinical laboratory shifts from baseline in blood chemistry values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. ALP=alkaline phosphatase, ALT=alanine aminotransferase, AST=aspartate aminotransferase, GGT=gamma-glutamyl transferase, LDH=lactate dehydrogenase, BUN=blood urea nitrogen.|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.|||participants|||Number
2661652|NCT01568112|Secondary|Clinical Laboratory Shifts From Baseline in Reported Values: Hematology|Number of participants with clinical laboratory shifts from baseline in hematology values. Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. abs=absolute|Day 1 to Week 8|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo); n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.|||participants|||Number
2661694|NCT01567943|Primary|Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine|Mean EtG value (in ng/mL). 150ng/mL or above = EtG-positive, 149ng/mL or below = EtG-negative. EtG = ethyl glucuronide, alcohol biomarker detectable in urine.|Over 16 weeks of treatment (repeated measure)||||EtG Value (nanograms per milileter)||Standard Error|Mean
2662489|NCT01562327|Secondary|Percentage of Participants Who Previously Received DMARDs||Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.|||percentage of participants|||Number
2661653|NCT01568112|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious AEs (SAEs)|AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes. An AE was considered treatment-emergent if it occurred after the start of study treatment or was present prior to the start of study treatment but subsequently worsened.|Day 1 up to end of Safety Follow-up (9 weeks)|Safety population: participants who received at least 1 dose of study treatment (BG00012/BG00012 placebo).|||participants|||Number
2661654|NCT01568112|Primary|Percentage of Participants Reporting GI Events During Weeks 5 to 8 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)|The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
2661655|NCT01568112|Primary|Percentage of Participants Reporting GI Events During Weeks 1 to 4 (Combined), as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)|The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.|Week 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
2661656|NCT01568112|Primary|Percentage of Participants Reporting GI Events During the Overall Treatment Period, as Assessed by the Modified Overall Gastrointestinal Symptom Scale (MOGISS)|The MOGISS is a questionnaire about overall side effects related to the gastrointestinal system (including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) during the 24 hours prior to each AM dose. Participants were to answer the questions at the same time each day, before the morning drug administration.|Day 1 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
2661657|NCT01568112|Primary|Worst Severity Scores of Acute GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS|Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||units on a scale||Standard Deviation|Mean
2661658|NCT01568112|Primary|Worst Severity Scores of Acute GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS|Severity of GI-related events using the MAGISS to measure GI symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, flatulence), based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms.|Day 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||units on a scale||Standard Deviation|Mean
2661659|NCT01568112|Primary|Percentage of Participants Reporting GI Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MAGISS|The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
2661660|NCT01568112|Primary|Percentage of Participants Reporting GI Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MAGISS|The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.|Day 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
2661661|NCT01568112|Primary|Percentage of Participants Reporting Gastrointestinal (GI) Events During the Overall Treatment Period, as Assessed by the Modified Acute Gastrointestinal Scale (MAGISS)|The MAGISS is a participant-reported questionnaire about side effects of the gastrointestinal system following drug administration, and is based on a 0- to 10-point scale, with 0 representing absence of symptoms and 10 representing the most severe symptoms. A participant was considered having overall GI side effect if he/she had a score of >=1 for at least one of the GI side effects including nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating and flatulence.|Day 1 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
2661722|NCT01567462|Secondary|Number of Participants With Disease Recurrence|The number of participants who had disease recurrence within the four month follow up period.|Post-Intervention (Up to 4 Months)|Participants who completed all study procedures per protocol.|||participants|||Number
2661662|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 of Treatment (Combined), as Assessed by MGFSS|Participant-reported flushing events during Weeks 5 to 8 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to last 24 hours flushing score.|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
2661663|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 of Treatment (Combined), as Assessed by MGFSS|Participant-reported flushing events during Weeks 1 to 4 of treatment (combined), recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1.|Day 2 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
2661664|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Global Flushing Severity Scale (MGFSS)|Participant-reported flushing events during the overall treatment period, recorded on the hand-held participant reporting device (eDiary) as assessed by MGFSS. The MGFSS measures the side effects related to flushing during the past 24 hours. Flushing means redness, warmth, tingling or itching of the skin. Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects). Day 1 data are not included in the analysis because MGFSS question refers to events reported in the 24 hours after the first dose on Day 1.|Day 2 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
2661665|NCT01568112|Primary|Worst Severity Scores of Overall Flushing During Weeks 5 to 8 of Treatment (Combined), as Assessed by MFSS|Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin.This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||units on a scale||Standard Deviation|Mean
2661666|NCT01568112|Primary|Worst Severity Scores of Overall Flushing During Weeks 1 to 4 of Treatment (Combined), as Assessed by MFSS|Worst severity of participant-reported flushing events during Weeks 1-4 of treatment combined, recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||units on a scale||Standard Deviation|Mean
2661667|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During Weeks 5 to 8 (Combined), as Assessed by MFSS|Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 5 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
2661668|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During Weeks 1 to 4 (Combined), as Assessed by MFSS|Participant-reported flushing side effect events during Weeks 1 to 4 recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Week 1 to Week 4|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
2661669|NCT01568112|Primary|Percentage of Participants Reporting Overall Flushing Events During the Overall Treatment Period, as Assessed by the Modified Flushing Severity Scale (MFSS)|Participant-reported flushing side effect events during the treatment period recorded on the eDiary as assessed by MFSS. MFSS questionnaire measures the side effects related to flushing following drug administration. Flushing means redness, warmth, tingling or itching of the skin. This questionnaire relates only to the period of time since the investigational drug was administered and was to be completed within 10 hours of taking the study drug (2 times/day). Each question is rated on a scale from 0 (no flushing side effects) to 10 (extreme flushing side effects).|Day 1 to Week 8|Participants who received at least 1 dose of study medication and who had at least 1 diary entry of the relevant questionnaire data during the visit interval.|||percentage of participants|||Number
2661723|NCT01567462|Secondary|Mean Catheterization Time|The average duration of the catheterization time was measured through study completion.|After Surgery Completion, Up to 336 Hours|Participants who required catheterization after the operative procedure.|||hours||Standard Deviation|Mean
2661670|NCT01568073|Secondary|Non-motor Symptoms Scale (NMSS)|"The Non-motor Symptoms Scale (NMSS) consists of 30 questions, covering 9 dimensions, whereby each item is scored for severity and frequency: Severity None 0 Mild (symptoms present but causes little distress) 1 Moderate (some distress or disturbance to subject) 2 Severe (major source of distress or disturbance to subject) 3~Frequency Rarely (<1/wk) 1 Often (1/wk) 2 Frequent (several times per week) 3 Very Frequent (daily or all the time) 4~The product of frequency and severity is calculated for each item and each dimension score is defined as the sum of the frequency*severity of the respective items. If frequency or severity of a single item is missing, the domain score will not be calculated. The NMSS total score is defined as the sum of all domain scores.~The NMSS total score is calculated by adding all domain scores (0-360), and lower scores mean less disability."|14 to 15 weeks||||units on a scale||Standard Deviation|Mean
2661671|NCT01568073|Secondary|Parkinson's Disease Sleep Scale (PDSS)|"The Parkinson's disease Sleep Scale (PDSS) is a specific scale for the assessment of sleep disturbances in subjects with PD. The PDSS score is calculated as the sum of all single items. If one or two items are missing, they will be imputed with the mean of the non-missing items. If three or more items are missing, no imputation will be done and the score will be set to missing.~Subscale has 0-10 ratings, where 0 = severe and 10 = normal~The PDSS total score is a sum score of all 15 questions and ranges from 0 to 150, with lower scores meaning more disability."|14 to 15 weeks||||units on a scale||Standard Deviation|Mean
2661672|NCT01568073|Secondary|Total UPDRS SCORE (I, II (ON), and III)|"Total UPDRS (Part I, II (ON) and III)~UPDRS I evaluation of mentation, behavior, and mood~UPDRS II self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food~UPDRS III clinician-scored monitored motor evaluation The UPDRS I, II and III scores and subscores are calculated as the sum of all individual items. If one or two items in a scale are missing, they will be imputed with the mean of the non-missing items of that scale.~Subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe~The final cumulative score will range from 0 (no disability) to 199 (total disability)."|14 to 15 weeks||||units on a scale||Standard Deviation|Mean
2661673|NCT01568073|Primary|Efficacy of 3 BIA 9-1067 (5 mg, 25 mg, and 50 mg) Compared With 200 mg of Entacapone or Placebo,|The primary efficacy variable will be the change from baseline in absolute OFF-time at the end of the DB period, This results refers when administered with the existing treatment of L-DOPA plus a DDCI, in patients with PD and end-of-dose motor fluctuations|14 to 15 weeks||||minutes||Standard Error|Mean
2661674|NCT01568047|Primary|Tmax - Time to Observed Maximum Concentration|"Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses.~Test Period - After the baseline period during the 21 to 28 days"|28 days||||ng/mL||Full Range|Median
2661675|NCT01568047|Secondary|AUC0-6 - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to to 6 h Postdose (AUC [0-6])|"Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses.~Test Period - After the baseline period during the 21 to 28 days"|28 days||||ng.h/mL||Standard Deviation|Mean
2661676|NCT01568047|Primary|Cmax - Observed Maximum Concentration|"Baseline period - to be switched respectively to standard-release levodopa/carbidopa 100/25 mg (Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) and to adjust the number of daily doses.~Test Period - After the baseline period during the 21 to 28 days"|28 days||||ng/mL||Standard Deviation|Mean
2661677|NCT01568034|Primary|Tmax = Time to Cmax Day 3|tmax = time to Cmax (values are median)|Day 3||||hours||Full Range|Median
2661678|NCT01568034|Secondary|AUC0-6 - Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours Post-dose (Day 3)|AUC0-6 - area under the plasma concentration-time curve from time 0 to 6 hours post-dose (ng.h/mL)|Day 3||||ng.h/mL||Standard Deviation|Mean
2661679|NCT01568034|Primary|Cmax - Maximum Plasma Concentration Day 3|Cmax - Maximum plasma concentration (ng/mL)|Day 3||||ng/ml||Standard Deviation|Mean
2661680|NCT01568021|Secondary|Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT)|Central Retinal Thickness was measured in the study eye using OCT, a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicated an improvement.|Baseline, Weeks 12, 24 and 48|All participants with complete data at the given time-point.|||microns||Standard Deviation|Mean
2661681|NCT01568021|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) Score|BCVA was measured in the study eye using an eye chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision improved.|Baseline, Weeks 12, 24 and 48|All participants with complete data at the given time-point.|||letters||Standard Deviation|Mean
2661682|NCT01568021|Primary|Time to First Re-treatment|Time to first re-treatment was defined as the time in days between the first administration of Ozurdex® and the following administration of Ozurdex® (re-treatment) in the study eye.|1 Year|All Participants with complete data.|||days||95% Confidence Interval|Median
2661683|NCT01568008|Primary|Intraocular Pressure (IOP) at Week 12|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left eye and the right eye at Week 12. The lower the IOP values the greater the improvement.|Week 12|All patients with complete data available for IOP.|||mm Hg||Standard Deviation|Mean
2661684|NCT01568008|Primary|Intraocular Pressure (IOP) at Baseline|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at Baseline.|Baseline|All patients with complete data available for IOP.|||mm Hg||Standard Deviation|Mean
2661685|NCT01568008|Secondary|Number of Patients Continuing Treatment After 12 Weeks|The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment?|12 weeks|All patients with data available for this outcome measure.|||Participants|||Number
2661686|NCT01568008|Secondary|Physician Reported Reasons for Treatment Discontinuation|The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient.|12 weeks|All patients with data available for this outcome measure.|||Participants|||Number
2661695|NCT01567891|Secondary|Correlate NY-ESO-1 Expression in Tumor Tissue Before Treatment With Archival Tumor Tissue to Assess Impact of Therapy on Expression of NY-ESO-1 Protein|"NY-ESO-1 expression as determined by Histoscore (H score). Histoscore (0-300) represents the amount of NY-ESO-1 protein present in the tissue sample.~H-Score formula:~[1 × (% cells 1+) + 2 × (% cells 2+) + 3 × (% cells 3+)]~(It is not clearly established if NY-ESO-1 H score has an association with prognosis.)"|Screening and at Baseline|Data is presented for 2 subjects, 4 subjects declined Baseline biopsy or biopsy wasn't collected due to safety concerns|||H score|||Number
2661696|NCT01567891|Secondary|Determine Functional Properties and Phenotype of Modified T-cells From Peripheral Blood.|Percentage of CD4+pentamer+ or CD8+pentamer+ cells expressing LAG-3, PD-1, TIM-3 in the functionality of NY-ESO-1ᶜ²⁵⁹T cells in the manufactured product and post-treatment blood.|Weeks 4 and 8 post T-cell infusion||||percentage of T cell sub population|T-cell sub population||Number
2661697|NCT01567891|Secondary|Peak Persistence of Modified T-cells in the Peripheral Blood|Measurement of NY-ESO-1ᶜ²⁵⁹T cells in blood|Days: 1, 2-4, weeks 1 to 4, Week 8, 12 and Month 6, then every 3 months thereafter until progression then during LTFU|Participants who received NY-ESO-1ᶜ²⁵⁹T|||copies of WPRE/mcg of genomic PBMC DNA||Full Range|Mean
2661698|NCT01567891|Secondary|Tumor Response|Number of participants with response as assessed by Immune-related Response Criteria (irRC)|Change from baseline, every 4 weeks until month 3 and then every 3 month until disease progression|Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T|||Participants|||Count of Participants
2661699|NCT01567891|Primary|Adverse Events Related to Study Treatment|Number of Participants with Adverse Events related to study treatment|Up to 12 months|Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T|||Participants|||Count of Participants
2661700|NCT01567865|Secondary|Number/Percentage of Subjects With Other Adverse Events (AE) During the Study|Adverse events other than solicited reactogenicities were obtained through review of medical history when subject returned to clinic. They were graded for severity and rated by the PI for possible relationship to vaccination throughout the 28 days study period.|Between 7 and 28 days of vaccination|All subjects receiving the vaccine were evaluated for this measure.|||Participants|||Count of Participants
2661701|NCT01567865|Secondary|Number/Percentage of Subjects With a Solicited Local or Systemic Reactogenicity Event Within 7 Days After Vaccination|Collected by a home visit to observe the subject and interview his/her parent or guardian occurrence and severity of solicited injection site reactogenicity events (REs) related to vaccination and solicited systemic REs or other AEs that might or might not be related to the prior receipt of vaccine|Within 7 days of vaccination|All subjects receiving the vaccine were assessed for this measure.|||Participants|||Count of Participants
2661702|NCT01567865|Secondary|Number/Percentage of Subjects With an Immediate Solicited Local or Systemic Reactogenicity Event (RE)|"Subjects were monitored for the following adverse events and categorized as events almost certainly related to receipt of the vaccine:~Redness Swelling Tenderness Dyspnea Cyanosis Loose Stools Vomiting Convulsion Fever (37 degrees Celsius or greater, axillary) Hives (urticaria) Angioedema"|Within 30 minutes of vaccination|All study subjects receiving vaccine were included in this measure.|||Participants|||Count of Participants
2661703|NCT01567865|Primary|Geometric Mean Titers (GMT)|Geometric Mean Titers of Neutralizing anti-JEV antibody|28 days post-vaccination|Per-Protocol Population|||titer||95% Confidence Interval|Geometric Mean
2661704|NCT01567865|Primary|Number/Percentage of Subjects With Demonstrated Seroprotection|"Seroprotection was defined as a serum antibody titer equal to or greater than 1:10, as measured by Plaque reduction neutralization test (PRNT). The end point for neutralization was the highest dilution of serum reducing the number of plaques by 50%, compared with a negative serum control.~In 2004, a group of experts under the leadership of the WHO recommended that seroprotection (SP) against JEV be defined as a neutralizing anti-JEV antibody serum titer ≥1:10 as determined by PRNT [Hombach et al. 2005]. Accordingly, a titer of ≥1:10 was adopted as an indicator of seroprotection in this study."|28 days post-vaccination|Per protocol population|||Participants|||Count of Participants
2661705|NCT01567852|Primary|Recovery Time|Recovery was assessed using 5 criteria (blood pressure, voluntary movement, oxygen requirement, consciousness, respiratory effort). Each criteria was scored from 0-2, with a full score of 10. The patient is scored at baseline, and is deemed recovered when all criteria has reached baseline score again.|1 hour|Please see description from outcome 1|||minutes||Standard Deviation|Mean
2661706|NCT01567852|Primary|Re-orientation Time|Patients will be scored based on 5 questions (name, age, year, day of week, location). Each patient will be scored prior to induction as to how many questions they score correctly. Patient is deemed re-oriented when they score the same as baseline after the treatment.|1 hour|Since this was a crossover study, all patients received both drugs, except for 2 patients who dropped out after receiving the first drug. For one of these patients the drug was ketamine, for the other the drug was methohexital. Number of total trials analyzed was 69, with 35 Ketamine trials and 34 Methohexital trials|||minutes||Standard Deviation|Mean
2661707|NCT01567839|Primary|Successful Pulpal Anesthesia.|Two consecutive 80/80 readings (no patient response) during 60 minutes of testing with an electric pulp tester.|60 minutes||||participants|||Number
2661708|NCT01567826|Secondary|Blood Chemistry - HsCRP|Correlation of yellow plaque index with changes in levels of blood HsCRP as compared from baseline to 6-8 weeks after intervention|at baseline and at 6-8 weeks after intervention||||mg/l||Inter-Quartile Range|Median
2661709|NCT01567826|Secondary|Major Adverse Cardiac Events (MACE)|MACE defined as a combined clinical endpoint of death, MI (Q wave or non Q-wave with CK-MB >3 times above the upper normal limit (48 U/L), urgent revascularization or stroke at 30 days and 1 year. Details reported in adverse events section.|at 6-8 weeks after intervention||||participants|||Number
2661710|NCT01567826|Secondary|Post PCI Cardiac Enzymes|Correlation of yellow plaque index with post procedure CK-MB, Troponin-I release.|at 6-8 weeks after intervention||||ng/mL||Standard Deviation|Mean
2661711|NCT01567826|Secondary|Diameter Stenosis|Percentage stenosis of vessel diameter in the analysis segment of nontarget lesions as measured by angiography that remained >70%, after successful PCI of the target lesion.|Baseline and 6-8 weeks post intervention||||percentage of lesions|||Number
2661724|NCT01567462|Secondary|Mean Operative Time|The average operative time was measured through study completion.|After Surgery Completion, Up to 174 Minutes|Participants who completed all study procedures per protocol.|||minutes||Standard Deviation|Mean
2661712|NCT01567826|Secondary|Fractional Flow Reserve (FFR) Value|Change in FFR as related to change in yellow plaque index as compared from baseline to 6-8 weeks after intervention. Fractional flow reserve (FFR), defined as the ratio of maximum flow in the presence of a stenosis to normal maximum flow, is a lesion-specific index of stenosis severity that can be calculated by simultaneous measurement of mean arterial, distal coronary, and central venous pressure.|at baseline and at 6-8 weeks after intervention||||ratio||Standard Deviation|Mean
2661713|NCT01567826|Secondary|Intravascular Ultrasound (IVUS) Parameters|"Change in atheroma volume and lumen CSA on IVUS as related to change in yellow plaque index as compared from baseline to 6-8 weeks after intervention.~Data not analyzed. Data not available."|at baseline and at 6-8 weeks after intervention||||mm^2||Standard Deviation|Mean
2661714|NCT01567826|Primary|Change in LCBI, Lesion|Change in LCBI at 6-8 weeks after intervention as compared to baseline|at baseline and at 6-8 weeks post intervention|Data were not available in 17 patients because of loss to follow-up (n = 5), incorrect image formatting that could not be recovered at the time of core laboratory analysis (n = 5), NIRS console/catheter malfunction at the time of index PCI (n = 3), and loss of disc integrity or corruption before core laboratory analysis (n = 4).|||ratio||95% Confidence Interval|Median
2661715|NCT01567826|Primary|Change in LCBI4mm Max|Change in LCBI4mm max at 6-8 weeks after intervention as compared to baseline. LCBI4mm max = change in lipid-core burden index at the 4-mm maximal segment.|at baseline and at 6-8 weeks after intervention|Data were not available in 17 patients because of loss to follow-up (n = 5), incorrect image formatting that could not be recovered at the time of core laboratory analysis (n = 5), NIRS console/catheter malfunction at the time of index PCI (n = 3), and loss of disc integrity or corruption before core laboratory analysis (n = 4).|||ratio||95% Confidence Interval|Median
2661716|NCT01567826|Primary|LCBI4mm Max|LCBI4mm max = change in lipid-core burden index at the 4-mm maximal segment. Spectroscopic information obtained from raw spectra was transformed into a probability of lipid core that was mapped to a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow. Yellow pixels within the analyzed segment were divided by all viable pixels to generate the lipid-core burden index (LCBI). The maximal value of LCBI for each nonculprit obstructive lesion was recorded and used for comparison.|at baseline and at 6-8 weeks after intervention|Data were not available in 17 patients because of loss to follow-up (n = 5), incorrect image formatting that could not be recovered at the time of core laboratory analysis (n = 5), NIRS console/catheter malfunction at the time of index PCI (n = 3), and loss of disc integrity or corruption before core laboratory analysis (n = 4).|||ratio||Inter-Quartile Range|Median
2661717|NCT01567826|Primary|Lipiscan - Lipid Core Burden Index (LCBI)|The regression of yellow plaque content from the atherosclerotic lipid pool after statin therapy by utilizing NIR spectroscopy as compared from baseline to 6-8 weeks after intervention. Spectroscopic information obtained from raw spectra was transformed into a probability of lipid core that was mapped to a red-to-yellow color scale, with the low probability of lipid shown as red and the high probability of lipid shown as yellow. Analyses were performed offline using the Matlab-based software, as previously published. Yellow pixels within the analyzed segment were divided by all viable pixels to generate the lipid-core burden index (LCBI). The maximal value of LCBI for each nonculprit obstructive lesion was recorded and used for comparison.|at baseline and at 6-8 weeks after intervention|Data were not available in 17 patients because of loss to follow-up (n = 5), incorrect image formatting that could not be recovered at the time of core laboratory analysis (n = 5), NIRS console/catheter malfunction at the time of index PCI (n = 3), and loss of disc integrity or corruption before core laboratory analysis (n = 4).|||ratio||Inter-Quartile Range|Median
2661718|NCT01567527|Secondary|Time From Randomization to Recurrence Defined by Hospitalization for a Mood Episode.|"Analysis of time from randomization to recurrence defined by hospitalization for a mood episode (Double-blind, Placebo-controlled Phase efficacy sample).~Time to recurrence is presented in the following table."|Baseline of the Double-blind, Placebo-controlled Phase up to the end of the study (Week 52).|All randomized subjects who received at least one injection of IMP and had at least one post-baseline efficacy assessment in the Double-blind, Placebo-controlled Phase, eg, modified ITT population.|||Days||95% Confidence Interval|Median
2661719|NCT01567527|Secondary|Mean Change From Randomization to Endpoint in the CGI-BP-S (Mania) Score.|CGI-BP-S assessed the subject's severity of Illness (mania) based on a 7-point scale ranging from 1 (normal/ not ill at all) to 7 (very severely ill).|Baseline of the Double-blind, Placebo-controlled Phase up to the end of the study (Week 52).|All randomized subjects who received at least one injection of IMP and had at least one post-baseline efficacy assessment in the Double-blind, Placebo-controlled Phase, eg, modified ITT population.|||Units on a scale||Standard Error|Least Squares Mean
2661720|NCT01567527|Secondary|Number of Subjects Meeting Criteria for Recurrence of Any Mood Episode.|To assess the proportion of subjects who met criteria for recurrence of any mood episode (manic, mixed or depressive). Hierarchical procedure was used to preserve the overall Type I error at 0.05.|Baseline of the Double-blind, Placebo-controlled Phase Up to the end of the study (Week 52).|All randomized subjects who received at least one injection of IMP and had at least one post-baseline efficacy assessment in the Double-blind, Placebo-controlled Phase, eg, modified ITT population.|||Participants|||Count of Participants
2661721|NCT01567527|Primary|Time From Randomization to Recurrence of Any Mood Episode During Double-bind Placebo-controlled Phase.|"This endpoint was defined as meeting any of the following criteria:~Hospitalization for any mood episode OR~Any of the following:~YMRS total score ≥ 15 OR~MADRS total score ≥ 15 OR~CGI-BP-S score > 4 (overall score) OR~SAE of worsening disease (bipolar I disorder) OR~Discontinuation due to lack of efficacy or discontinuation due to an AE of worsening disease OR~Clinical worsening with the need for treatment of symptoms of an underlying mood disorder by addition of a mood stabilizer, antidepressant treatment, antipsychotic medication, or increase greater than the allowed benzodiazepine doses, or~Active suicidality, which is defined as a score of 4 or more on the MADRS item 10 OR an answer of yes on question 4 or 5 on the C-SSRS.~The time to event is presented in the following table."|Baseline of the Double-blind, Placebo-controlled Phase Up to the end of the study (Week 52).|All randomized subjects who received at least one injection of investigational medicinal product (IMP) and had at least one post-baseline efficacy assessment in the Double-blind, Placebo-controlled Phase, eg, modified intent-to-treat (ITT) population.|||Days||95% Confidence Interval|Median
2661725|NCT01567462|Primary|Number of Procedural Complications|The number of procedural complications describes the total number of post-operative bleeding, need for blood transfusion, bladder perforation, obturator nerve stimulation, catheterization time, or need for hospitalization or bladder irrigation events that occur within thirty days of the procedure.|Post-Intervention (Up to 30 Days)|Participants who completed all study procedures per protocol.|||complications|||Number
2661726|NCT01567371|Secondary|Difference in Stroke Volume Variability From Baseline to Post ANH.|The difference in stroke volume variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.|1 Day||||% variability||Standard Deviation|Mean
2661727|NCT01567371|Primary|Difference in Pulse Pressure Variability From Baseline to Post-ANH|The difference in pulse pressure variability during a period of phlebotomy and graded blood loss, measured before phlebotomy or acute normovolemic hemodilution (ANH) and immediately after.|1 Day||||% variability||Standard Deviation|Mean
2661728|NCT01567306|Secondary|All Adverse Reactions and or Events Will be Recorded Both by the Patient and the Health Care Personnel Responsible for the Administration of the Subcutaneous Immunotherapy.|All adverse reactions and/or events were recorded both by the patient and the health care personnel responsible for the administration of the subcutaneous immunotherapy. The incidence and intensity of adverse events was compared among the treatment groups.|From baseline (V0) to final visit (VF). The Final Visit will be conducted within 7 plus minus 2 days after the last dose is administered. All AE should be monitored until they are satisfactorily resolved or stabilized after the final visit of the study|||||||
2661729|NCT01567306|Primary|Variation of the Concentration of Phleum Pratense Extract Needed to Produce a Positive Nasal Provocation Test From Baseline (V0) to Final Visit (FV).|Variation of the concentration of Phleum pratense extract needed to produce a positive nasal provocation test from baseline (V0) to final visit (FV). The changes will be compared among groups (including the placebo group).|Baseline (V0) and Final Visit (FV). The Final Visit will be conducted within 7 plus minus 2 days after the last dose is administered. The study will be carried out outside the pollination season of Phleum pratense.|Intent-to-treat population (ITT): This population included all randomized patients who received at least one treatment dose and who presented baseline and post-baseline values for the primary efficacy variable.|||SPT||Standard Deviation|Mean
2661730|NCT01567163|Secondary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Docetaxel||Cycle 2: 1 hour prior to ramucirumab infusion, 0, 1, 2, 2.5, 3, 4, 6, 8, 25, 49, 73, 169, 265 and 337 hours post ramucirumab infusion|All enrolled participants who received ramucirumab and had sufficient concentration data to calculate ramucirumab Cmax in Cycle 2.|||micrograms/milliliter (mcg/mL)||Geometric Coefficient of Variation|Geometric Mean
2661731|NCT01567163|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Docetaxel||Cycle 2: 1 hour prior to ramucirumab infusion, 0, 1, 2, 2.5, 3, 4, 6, 8, 25, 49, 73, 169, 265 and 337 hours post ramucirumab infusion|All enrolled participants who received ramucirumab and had sufficient concentration data to calculate ramucirumab AUC(0-∞) in Cycle 2.|||micrograms*hour/milliliter (mcg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2661732|NCT01567163|Secondary|Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies|Participants with treatment-emergent anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).|Cycle 1, Day 1 through Cycle 2, Day 1 and 30 days after last dose of study drug|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment who had immunogenicity samples collected at the specified time points.|||participants|||Number
2661733|NCT01567163|Primary|Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 2||Cycle 2: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel Cmax in Cycle 2.|||nanograms/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
2661734|NCT01567163|Primary|Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 1||Cycle 1: 0, 1, 1.5, 2, 3, 5, 7, 24, 48, and 72 hours post docetaxel infusion|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel Cmax in Cycle 1.|||nanograms/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
2661735|NCT01567163|Primary|Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Docetaxel From Time Zero to Infinity [AUC(0-∞)] Following a Single Dose in Cycle 2||Cycle 2: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel AUC(0-∞) in Cycle 2.|||nanograms*hour/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
2661736|NCT01567163|Primary|Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Docetaxel From Time Zero to Infinity [AUC(0-∞)] Following a Single Dose in Cycle 1||Cycle 1: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion|All participants who completed Cycle 1, Day 1 and Cycle 2, Day 1 treatment and had sufficient concentration data to calculate docetaxel AUC(0-∞) in Cycle 1.|||nanograms*hour/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
2661737|NCT01567150|Secondary|Wound Healing|change in wound area mean was calculated for each subject Mean and sd were calculated for each group|12 weeks|average across 12 week time frame|||square cm||Standard Deviation|Mean
2661738|NCT01567150|Primary|Matrix Metalloproteinase Level in Wound Fluid|"Wound fluid will be collected and analyzed at baseline and approximately every 7 days.~Mean was calculated for each subject. Means and standard deviation were calculated for the treatment and control groups."|8 weeks|Overall mean across 8 week timeframe|||mcg/ml||Standard Deviation|Mean
2661739|NCT01567085|Other Pre-specified|Participants That Developed Severe ACR (Other AE Of Interest) At Month 12|This outcome measure focuses on the other AE of interest, severe ACR, which occurred at Month 12. It pertains specifically to the number of participants who developed severe ACR that did not respond to thymoglobulin or other lymphocyte-depleting agents. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline, Month 12|Safety Population: participants who received at least 1 dose of eculizumab.|||Participants|||Count of Participants
2661740|NCT01567085|Other Pre-specified|Cumulative Incidence Function (CIF) Of Other Adverse Events (AEs) Of Interest At Month 12|Specific analyses of other AEs of interest that occurred at Month 12 included cumulative incidence of clinically significant infection (CSI); post-transplant lymphoproliferative disease (PTLD); malignancies; biopsy-proven acute cellular rejection (ACR) of any grade meeting Banff 2007 criteria; allograft loss for reasons other than AMR. CSIs were defined as infections (confirmed by culture, biopsy, genomic, or serologic findings) that required hospitalization or anti-infective treatment, or otherwise deemed significant by the Investigator. CSI subcategories of interest included cytomegalovirus (CMV) disease; BK virus disease; encapsulated bacterial infection; fungal infections; aspergillus infections. Results are reported as CIF, where a larger CIF indicates a higher incidence of an AE, and were calculated using Statistical Analysis System software and macro CIF. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline, Month 12|Safety Population: enrolled participants who received at least 1 dose of eculizumab.|||Proportion of Adverse Events||95% Confidence Interval|Number
2661741|NCT01567085|Primary|Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation|Results are reported for post-transplantation treatment failure and composite endpoints, defined as the occurrence of biopsy-proven acute antibody-mediated rejection (AMR), graft loss, death, or loss to follow-up (including discontinuation) in the first 9 weeks post transplantation. The diagnosis of acute AMR (occurring within the first 9 weeks post transplantation) was based on kidney allograft dysfunction and a biopsy performed due to suspected rejection, proteinuria, increased serum creatinine, or acute tubular necrosis. Treatment failure was the occurrence of at least 1 of the composite endpoint components by Week 9 post transplantation. A participant experiencing multiple events was only counted once for the composite endpoint.|Baseline, Week 9|Full Analysis Population: participants who were enrolled, received a deceased donor kidney transplant, and received at least 1 dose of eculizumab.|||Participants|||Count of Participants
2661742|NCT01567020|Secondary|Percent Change in P2 Component of Electrophysiological Response|Average change in amplitude of the P2 component of the electrophysiological response to paired clicks. Habituation to the clicks is anticipated, resulting in a large percentage change in amplitude to the second click.|six months|This analysis was only conducted on a subset of the sample, as not all were available for further testing.|||Percent Change||Standard Deviation|Mean
2661743|NCT01567020|Secondary|Functional Hearing Ability in Multitalker Environments|The Functional Hearing Questionnaire (FHQ), developed for veterans with brain injuries was used to evaluate self perceived hearing difficulties. The FHQ is a nine item questionnaire that asks participants to rate their level of difficulty hearing in different circumstances on a four point scale. Scores range from 9 to 36, with higher scores indicating a greater level of difficulty.|six months|Not all participants were available for further testing.|||scores on a scale||Standard Deviation|Mean
2661744|NCT01567020|Secondary|Ratings of Self-reported Ability to Process Auditory Information in Various Settings|Hearing Health Inventory for Adults is a 25 item questionnaire that asks participants to rank how often auditory issues create problems in daily life. Scores range from 0 to 100, with higher scores indicating greater perceived levels of handicap.|six months|Not all participants were available for further testing.|||score on a scale||Standard Deviation|Mean
2661745|NCT01567020|Primary|Number of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory Processing|"Tests to be administered:~Dichotic Digits Test: Percentage of digits reported correctly from 0 (worst performance) to 100 (best performance) Gaps in Noise Test: Approximate threshold in milliseconds from 2 (best) to 20 (worst) Staggered Spondaic Words Test: Total number of errors from 0 (best) to 40 (worst) Masking Level Differences Test: Difference in threshold between diotic and dichotic stimuli in decibels from 0 (worst) to 24 (best) Frequency Pattern Test: Percentage of sequences reported correctly from 0 (worst performance) to 100 (best performance) Adaptive Tests of Temporal Resolution: Not reported due to software error in stimulus presentation"|six months|Note that some of the participants finished all of the primary outcome measures but withdrew without finishing all of the secondary tests. They are thus listed as having withdrawn but are still included here for completeness.|||units on a scale||Standard Deviation|Mean
2661746|NCT01566981|Secondary|Change of the Following Parameter : HbA1C||baseline and six months|||||||
2661747|NCT01566981|Secondary|Change of Blood Lipid Level ( Low Density Cholesterol)||baseline and six months|||||||
2661748|NCT01566981|Secondary|Change of Patients' Functional Health Status Via WONCA-COOP Questionnaire.||baseline and one year||2013-11-30|11/2013||||
2661749|NCT01566981|Secondary|Quality of Patients' Life Via WONCA-COOP Questionnaire.||baseline and one year|||||||
2661750|NCT01566981|Secondary|Change of Blood Lipid Level ( Low Density Cholesterol)||baseline and one year|||||||
2661751|NCT01566981|Secondary|Patients' Functional Health Status Via WONCA-COOP Questionnaire.|WONCA COOP questionnaire measure seven core aspects of functional status, therefore this instrument consists of 7 five-point ordinal sub-scales. Each scale ranging from 1 ('no limitation at all') to 5 ('severely limited'); for 'change in health' score 1 means 'much better' and score 5'much worse'. Sub-scales are averaged to compute a total score.|one year||||units on a scale||Standard Deviation|Mean
2661752|NCT01566981|Secondary|Body Mass Index at 1 Year||one year||||Kg/m2||Standard Deviation|Mean
2661753|NCT01566981|Primary|Change From Baseline in HbA1C at 1 Year.||1 year||||percentage of glycated haemoglobin||Standard Deviation|Mean
2661754|NCT01566838|Secondary|Resumed Physical Activity|Did the patient resume physical activity.|30 days|Resuming of physical activity|||participants|||Number
2661755|NCT01566838|Secondary|Return to Work|Returned to work in 30 days?|30 days|30 day return to work|||participants|||Number
2661756|NCT01566838|Secondary|30-day Incidence of Parasthesia|30-day incidence of paresthesia (tingling or pricking sensation, usually caused by pressure or nerve damage)|30 days|30-day incidence of paresthesia|||participants|||Number
2661757|NCT01566838|Secondary|Length of Stay|Hospital length of stay for this operation will be recorded and analyzed for each arm of the study.|Participants will be followed for the duration of hospital stay, an expected average of 5 days|In-hospital length of stay (days)|||days||Inter-Quartile Range|Median
2661758|NCT01566838|Secondary|7-day Paresthesia|Participants experiencing parasthesia (a tingling or pricking sensation usually caused by pressure or damage to nerves) through postoperative day 7|Postoperative day 1 through day 7|7-day paresthesia|||participants|||Number
2661762|NCT01566773|Secondary|Change From Baseline in Mean Evening Post-dose Daily PEFR|Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)|Through the end of the 14-Day Treatment|MITT Population|||L/min||95% Confidence Interval|Least Squares Mean
2661763|NCT01566773|Secondary|Change From Baseline in Mean Evening Pre-dose Daily PEFR|Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)|Treatment Day 1 to the end of the 14-Day Treatment, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)|MITT Population|||L/min||95% Confidence Interval|Least Squares Mean
2661764|NCT01566773|Secondary|Change From Baseline in Mean Morning Post-dose Daily PEFR|Change from baseline in mean morning post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1]|Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period 30 minutes post dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)|MITT Population|||L/min||95% Confidence Interval|Least Squares Mean
2661765|NCT01566773|Secondary|Change From Baseline in Mean Morning Pre-dose Daily PEFR|Change from baseline in mean morning pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1]|Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period before dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)|MITT Population|||L/min||95% Confidence Interval|Least Squares Mean
2661766|NCT01566773|Secondary|Change From Baseline in 12-hour Post-dose Trough FEV1|12-hour post-dose trough FEV1 was defined as the mean of the FEV1 assessments taken at 11.5 and 12 hours post-dose minus the baseline|Day 14 (Baseline, 11.5 and 12 hours post dose)|MITT Population|||mL||95% Confidence Interval|Least Squares Mean
2661767|NCT01566773|Secondary|Peak Change From Baseline in IC|Peak change from baseline in IC (mean of 1 and 2 hour post-dose assessments minus the baseline)|Day 14 (mean of 1 and 2 hour post-dose assessments minus the baseline)|MITT Population|||mL||95% Confidence Interval|Least Squares Mean
2661768|NCT01566773|Secondary|Change From Baseline for Mean Morning Pre-dose Trough IC|Change from baseline for mean morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)|Day 14 (average of the 60 and 30-minute pre-dose assessments minus the baseline)|MITT Population|||mL||95% Confidence Interval|Least Squares Mean
2661769|NCT01566773|Secondary|Peak Change From Baseline in FEV1|Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)|Day 14|MITT Population|||mL||95% Confidence Interval|Least Squares Mean
2661770|NCT01566773|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1|Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)|Day 14 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)|MITT Population|||mL||95% Confidence Interval|Least Squares Mean
2661771|NCT01566773|Secondary|Mean Number of Puffs of Rescue Medication|Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated|Day 7|MITT Population|||Puffs||95% Confidence Interval|Mean
2661772|NCT01566773|Secondary|Change From Baseline in Mean Evening Post-dose PEFR|Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)|Day 7|MITT Population|||L/min||95% Confidence Interval|Least Squares Mean
2661773|NCT01566773|Secondary|Change From Baseline in Mean Evening Pre-dose PEFR|Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)|Day 7|MITT Population|||L/min||95% Confidence Interval|Least Squares Mean
2661774|NCT01566773|Secondary|Change From Baseline in Morning Post-dose Daily PEFR|Change from baseline in morning post-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1])|Day 7 (30 minutes post-dose)|MITT Population|||L/min||95% Confidence Interval|Least Squares Mean
2661775|NCT01566773|Secondary|Change From Baseline in Mean Morning Pre-dose Daily PEFR|Change from baseline in mean morning pre-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1])|Day 7 (60 minutes pre-dose, 30 minutes pre-dose)|MITT Population|||L/min||95% Confidence Interval|Least Squares Mean
2661776|NCT01566773|Secondary|Peak Change From Baseline in IC|Peak change from baseline in IC (mean of 1 hr and 2 hr post-dose assessments)|Day 7 (mean of 1 hr and 2 hr post-dose assessments)|MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.|||mL||95% Confidence Interval|Least Squares Mean
2661777|NCT01566773|Secondary|Change From Baseline in Morning Pre-dose Trough Inspiratory Capacity (IC)|Change from baseline in morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)|Day 7|MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.|||mL||95% Confidence Interval|Least Squares Mean
2661778|NCT01566773|Secondary|Peak Change From Baseline in FEV1|Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)|Day 7|MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.|||mL||95% Confidence Interval|Least Squares Mean
2661915|NCT01566461|Secondary|Primary Sustained Clinical Improvement|Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
2661779|NCT01566773|Secondary|Change From Baseline in Morning Pre-dose Trough FEV1|Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)|Day 7 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)|MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.|||mL||95% Confidence Interval|Least Squares Mean
2661780|NCT01566773|Secondary|Peak Change From Baseline in Inspiratory Capacity (IC)|Peak change in Inspiratory Capacity (IC) mean of 1 and 2 hour post-dose assessments minus the baseline|Day 1 (1 hr and 2 hr post-dose )|MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.|||mL||95% Confidence Interval|Least Squares Mean
2661781|NCT01566773|Secondary|Percentage of Subjects Achieving at Least 12% Improvement in FEV1|Percentage of subjects achieving at least 12% improvement in FEV1.|Day 1|MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.|||Percentage of participants|||Number
2661782|NCT01566773|Secondary|Time to Onset of Action (>10% Improvement in FEV1) on Day 1|Time to Onset of Action (>10% Improvement in FEV1) on Day 1.|Day 1 (15 min, 30 min, 1 hr, 2 hrs, no onset within 2 hrs)|MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.|||% of participants|||Number
2661783|NCT01566773|Secondary|Peak Change From Baseline in FEV1|Highest value of FEV1 post dose on day 1|Day 1|MITT Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.|||mL||95% Confidence Interval|Least Squares Mean
2661784|NCT01566773|Primary|FEV1 AUC0-12|Forced expiratory volume in 1 second (FEV1) normalized area under the curve 0-12 hours (AUC0-12) following chronic dosing for 14 days.|Day 14 (-1 hr, -30 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, 11.5 hr, 12 hr)|MITT (Modified Intent to Treat) Population: Subjects who completed at least 2 treatment periods with minimally 2 hours post-dosing on Day 14 for each of the treatment periods.|||Liter||95% Confidence Interval|Least Squares Mean
2661785|NCT01566721|Secondary|Percentage of Participants by Item Response to SID Satisfaction Questionnaire|"The SID satisfaction questionnaire was administered twice during the study and asked participants to respond to five statements using a Likert scale from Strongly Disagree to Strongly Agree. Questionnaire items were as follows: I felt comfortable injecting the study drug by myself (Comfortable), The SID was convenient and easy to use (Easy to Use), I am confident giving myself an injection in the thigh with the SID (Confident), Taking all things into account I find self-administration using the SID satisfactory (Satisfactory), If given the opportunity I would choose to continue self-injecting the study drug using the SID in the future (Continue). Participants could only select one response per questionnaire item. There was no calculation of any score, but rather, descriptive summaries were generated by item response. The percentage of participants was reported by the response given for each item on the SID satisfaction questionnaire."|Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)|Safety Population. Only participants who performed self-administration were included. The number of participants who responded to the questionnaire item at each assessment (n) is shown in the table.|||percentage of participants|||Number
2661786|NCT01566721|Secondary|Overall Survival (OS)||From Baseline to time of event (up to approximately 8 years)|||||||
2661787|NCT01566721|Secondary|Percentage of Participants Who Died by Data Cutoff of 10 March 2015|The percentage of participants who died from any cause was reported.|From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)|ITT Population|||percentage of participants|||Number
2661788|NCT01566721|Secondary|Disease-Free Survival (DFS)|DFS is defined as the time from first dose of SC Herceptin to the first event of local, regional or distant recurrence, contralateral invasive breast cancer (including ipsilateral ductal carcinoma in situ) or death due to any cause.|From Baseline to time of event (up to approximately 8 years)|||||||
2661789|NCT01566721|Primary|Percentage of Participants Who Received Concomitant Non-Cancer Therapy|Concomitant non-cancer treatment included any pharmacologic interventions administered during the study other than chemotherapy, radiotherapy, or hormone therapy. The percentage of participants who received any concomitant non-cancer therapies was reported.|From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)|Safety Population|||percentage of participants|||Number
2661790|NCT01566721|Primary|Percentage of Participants Who Received Concomitant Cancer Therapy|Concomitant cancer treatment included chemotherapy, radiotherapy, and hormone therapy administered during the study. The percentage of participants who received any of these concomitant therapies was reported.|From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)|Safety Population|||percentage of participants|||Number
2661791|NCT01566721|Primary|Percentage of Participants by Total Number of Herceptin Cycles Received|Participants were planned to receive a total of 18 cycles of SC Herceptin. The percentage of participants was reported by the total number of cycles actually received. Because the data are presented non-cumulatively, this table reflects participant distribution by the highest number of cycles received.|From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)|Safety Population. The endpoint also included an analysis of a subgroup of participants from Cohort B who received doses of self-administered SC Herceptin via SID.|||percentage of participants|||Number
2661792|NCT01566721|Primary|Number of Herceptin Cycles Received|Participants were planned to receive a total of 18 cycles of SC Herceptin. The median number of cycles actually received was reported.|From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)|Safety Population. The endpoint also included an analysis of a subgroup of participants from Cohort B who received doses of self-administered SC Herceptin via SID.|||cycles||Full Range|Median
2661793|NCT01566721|Primary|Percentage of Participants With Treatment Interruption Due to an AE|Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with SC Herceptin treatment interrupted to assess or treat AEs was reported.|From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)|Safety Population|||percentage of participants|||Number
2661794|NCT01566721|Primary|Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period|Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. AEs were graded according to National Cancer Institute Common Terminology Criteria Version 4.0. Grade 3 AEs were those considered severe or medically significant but not immediately life-threatening. Grade 4 AEs were those considered life-threatening and/or for which urgent intervention was indicated. Grade 5 AEs were those resulting in death. The percentage of participants with a Grade 3 or higher (i.e., Grade 3 to 5) AE during the treatment period was reported.|From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)|Safety Population|||percentage of participants||95% Confidence Interval|Number
2661795|NCT01566721|Primary|Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period|Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with at least 1 AE during the treatment period (regardless of severity or seriousness) was reported.|From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)|Safety Population: All enrolled participants who received at least one dose of study medication according to assigned treatment.|||percentage of participants|||Number
2661796|NCT01566695|Secondary|Healthcare Resource Utilization (HRU): Total Number of Days Hospitalized Per Total Patient-Years|The number of days hospitalized per total patient years. HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient.|From date of randomization up to 28 days after the last dose of study drug; up to data cut off date of 25 January 2019; median duration of treatment to oral azacitaidine was 5.29 months and 5.36 months for placebo|The safety population includes all randomized participants who received at least one dose of study drug.|||Days Per Total Patient Years|||Number
2661797|NCT01566695|Secondary|Healthcare Resource Utilization (HRU): Total Number of Days Hospitalized Due to Any Reason During the Treatment Period|The total number of days hospitalized due to any reason during the treatment period was monitored. HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient.|From date of randomization up to 28 days after the last dose of study drug; up to data cut off date of 25 January 2019; median duration of treatment to oral azacitaidine was 5.29 months and 5.36 months for placebo|The safety population includes all randomized participants who received at least one dose of study drug.|||Days|||Number
2661798|NCT01566695|Secondary|Healthcare Resource Utilization (HRU): Number of Participants Who Were Hospitalized During the Treatment Period|The number of reasons for hospitalizations and hospital admissions during the treatment period were monitored and include those associated with: AEs, protocol-driven procedures, transfusions, non-protocol procedures, elective procedures or those associated with social, practical or technical reasons in the absence of AEs. HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient.|From date of randomization up to 28 days after the last dose of study drug; up to data cut off date of 25 January 2019; median duration of treatment to oral azacitaidine was 5.29 months and 5.36 months for placebo|The safety population includes all randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2661799|NCT01566695|Secondary|Percentage of Participants With Improved, Worsened, or No Change in the European Quality of Life-Five Dimension-Three Level in the Anxiety/Depression Dimension Responses at Cycle 6|The EQ-5D-3L is a generic, self-administered questionnaire that consists of 5 dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has 3 levels of severity corresponding to no problems, some problems, and extreme problems. It also includes a Visual Analog Scale that recorded the respondent's self-rated health on a vertical, 0-100 scale, where 100 = Best imaginable health state and 0 = Worst imaginable health state. Distribution of the observed responses (i.e., no problems, moderate problems, severe problems, and missing) of the 5 dimensions at each visit was summarized per arm. The denominator for the percentage calculation per group was based on the number of the EQ-5D-3L evaluable population at baseline. The distribution of change in responses (i.e., improved [by ≥1 level], no change, worsened [by ≥1 level], and missing) from baseline are reported.|From Baseline to Cycle 6 Day 1|The HRQoL evaluable population was defined as participants with a EQ-5D-3L health utility at baseline and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661800|NCT01566695|Secondary|Percentage of Participants With Improved, Worsened, or No Change in the European Quality of Life-Five Dimension-Three Level in the Pain/Discomfort Dimension Responses at Cycle 6|The EQ-5D-3L is a generic, self-administered questionnaire that consists of 5 dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has 3 levels of severity corresponding to no problems, some problems, and extreme problems. It also includes a Visual Analog Scale that recorded the respondent's self-rated health on a vertical, 0-100 scale, where 100 = Best imaginable health state and 0 = Worst imaginable health state. Distribution of the observed responses (i.e., no problems, moderate problems, severe problems, and missing) of the 5 dimensions at each visit was summarized per arm. The denominator for the percentage calculation per group was based on the number of the EQ-5D-3L evaluable population at baseline. The distribution of change in responses (i.e., improved [by ≥1 level], no change, worsened [by ≥1 level], and missing) from baseline are reported.|From Baseline to Cycle 6 Day 1|The HRQoL evaluable population was defined as participants with a EQ-5D-3L health utility at baseline and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661835|NCT01566695|Secondary|Time to Platelet Transfusion Independence|Time to platelet transfusion independence was defined as the time between randomization and the first documented date of onset of transfusion independence (ie, Day 1 of 56 without any platelet transfusions).|From the date of randomization of study drug up to the treatment period; up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo|Intent to Treat population; includes participants who achieved platelet transfusion independence for at least 56 days.|||Months||Full Range|Median
2661801|NCT01566695|Secondary|Percentage of Participants With Improved, Worsened, or No Change in the European Quality of Life-Five Dimension-Three Level Usual Activities Dimension Responses at Cycle 6|TThe EQ-5D-3L is a generic, self-administered questionnaire that consists of 5 dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has 3 levels of severity corresponding to no problems, some problems, and extreme problems. It also includes a Visual Analog Scale that recorded the respondent's self-rated health on a vertical, 0-100 scale, where 100 = Best imaginable health state and 0 = Worst imaginable health state. Distribution of the observed responses (i.e., no problems, moderate problems, severe problems, and missing) of the 5 dimensions at each visit was summarized per arm. The denominator for the percentage calculation per group was based on the number of the EQ-5D-3L evaluable population at baseline. The distribution of change in responses (i.e., improved [by ≥1 level], no change, worsened [by ≥1 level], and missing) from baseline are reported.|From Baseline to Cycle 6 Day 1|The HRQoL evaluable population was defined as participants with a EQ-5D-3L health utility at baseline and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661802|NCT01566695|Secondary|Percentage of Participants With Improved, Worsened, or No Change in the European Quality of Life-Five Dimension-Three Level of Self-Care Dimension Responses at Cycle 6|The EQ-5D-3L is a generic, self-administered questionnaire that consists of 5 dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has 3 levels of severity corresponding to no problems, some problems, and extreme problems. It also includes a Visual Analog Scale that recorded the respondent's self-rated health on a vertical, 0-100 scale, where 100 = Best imaginable health state and 0 = Worst imaginable health state. Distribution of the observed responses (i.e., no problems, moderate problems, severe problems, and missing) of the 5 dimensions at each visit was summarized per arm. The denominator for the percentage calculation per group was based on the number of the EQ-5D-3L evaluable population at baseline. The distribution of change in responses (i.e., improved [by ≥1 level], no change, worsened [by ≥1 level], and missing) from baseline are reported.|From Baseline to Cycle 6 Day 1|The HRQoL evaluable population was defined as participants with a EQ-5D-3L health utility at baseline and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661803|NCT01566695|Secondary|Percentage of Participants With Improved, Worsened, or No Change in the European Quality of Life-Five Dimension-Three Level (EQ-5D-3L) Mobility Dimension Responses at Cycle 6|The EQ-5D-3L is a generic, self-administered questionnaire that consists of 5 dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has 3 levels of severity corresponding to no problems, some problems, and extreme problems. It also includes a Visual Analog Scale that recorded the respondent's self-rated health on a vertical, 0-100 scale, where 100 = Best imaginable health state and 0 = Worst imaginable health state. Distribution of the observed responses (i.e., no problems, moderate problems, severe problems, and missing) of the 5 dimensions at each visit was summarized per arm. The denominator for the percentage calculation per group was based on the number of the EQ-5D-3L evaluable population at baseline. The distribution of change in responses (i.e., improved [by ≥1 level], no change, worsened [by ≥1 level], and missing) from baseline are reported.|From Baseline to Cycle 6 Day 1|The HRQoL evaluable population was defined as participants with a EQ-5D-3L health utility at baseline and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661804|NCT01566695|Secondary|Percentage of Participants With Change From Baseline in Responses to the Fact-Anemia Item GP-5|"The distribution (frequency and percentage) of the observed responses (i.e., Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4), and missing) to Item GP-5 (I am bothered by side effects of treatment in the past seven days) of the FACT-An at each scheduled visit were summarized for each treatment group. The denominator for the percentage calculation per treatment group was based on the number of the FACT-An evaluable population at baseline. The distribution of change in responses (improved [i.e., change score from 1 to 4], no change [0], worsened by one level [-1], worsened by ≥2 levels [-2 to -4], and missing) from baseline at each post-baseline scheduled visit were summarized by treatment group."|From Baseline to End of Treatment|The HRQoL evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score baseline visit and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661805|NCT01566695|Secondary|Percentage of Participants With Change From Baseline in Responses to the Fact-Anemia Item GP-5|"The distribution (frequency and percentage) of the observed responses (i.e., Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4), and missing) to Item GP-5 (I am bothered by side effects of treatment in the past seven days) of the FACT-An at each scheduled visit were summarized for each treatment group. The denominator for the percentage calculation per treatment group was based on the number of the FACT-An evaluable population at baseline. The distribution of change in responses (improved [i.e., change score from 1 to 4], no change [0], worsened by one level [-1], worsened by ≥2 levels [-2 to -4], and missing) from baseline at each post-baseline scheduled visit were summarized by treatment group."|From Baseline to Cycle 7 Day 1 (C7D1)|The HRQoL evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score baseline visit and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661806|NCT01566695|Secondary|Percentage of Participants With Change From Baseline in Responses to the Fact-Anemia Item GP-5|"The distribution (frequency and percentage) of the observed responses (i.e., Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4), and missing) to Item GP-5 (I am bothered by side effects of treatment in the past seven days) of the FACT-An at each scheduled visit were summarized for each treatment group. The denominator for the percentage calculation per treatment group was based on the number of the FACT-An evaluable population at baseline. The distribution of change in responses (improved [i.e., change score from 1 to 4], no change [0], worsened by one level [-1], worsened by ≥2 levels [-2 to -4], and missing) from baseline at each post-baseline scheduled visit were summarized by treatment group."|From Baseline to Cycle 6 Day 1 (C6 D1)|The HRQoL evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score baseline visit and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661916|NCT01566461|Secondary|Thrombosis at the Target Lesion||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
2661807|NCT01566695|Secondary|Percentage of Participants With Change From Baseline in Responses to the Fact-Anemia Item GP-5|"The distribution (frequency and percentage) of the observed responses (i.e., Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4), and missing) to Item GP-5 (I am bothered by side effects of treatment in the past seven days) of the FACT-An at each scheduled visit were summarized for each treatment group. The denominator for the percentage calculation per treatment group was based on the number of the FACT-An evaluable population at baseline. The distribution of change in responses (improved [i.e., change score from 1 to 4], no change [0], worsened by one level [-1], worsened by ≥2 levels [-2 to -4], and missing) from baseline at each post-baseline scheduled visit were summarized by treatment group."|From Baseline to Cycle 5 Day 1 (C5D1)|The HRQoL evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score baseline visit and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661808|NCT01566695|Secondary|Percentage of Participants With Change From Baseline in Responses to the Fact-Anemia Item GP-5|"The distribution (frequency and percentage) of the observed responses (i.e., Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4), and missing) to Item GP-5 (I am bothered by side effects of treatment in the past seven days) of the FACT-An at each scheduled visit were summarized for each treatment group. The denominator for the percentage calculation per treatment group was based on the number of the FACT-An evaluable population at baseline. The distribution of change in responses (improved [i.e., change score from 1 to 4], no change [0], worsened by one level [-1], worsened by ≥2 levels [-2 to -4], and missing) from baseline at each post-baseline scheduled visit were summarized by treatment group."|From Baseline to Cycle 4 Day 1 (C4D1)|The HRQoL evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score baseline visit and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661809|NCT01566695|Secondary|Percentage of Participants With Change From Baseline in Responses to the Fact-Anemia Item GP-5|"The distribution (frequency and percentage) of the observed responses (i.e., Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4), and missing) to Item GP-5 (I am bothered by side effects of treatment in the past seven days) of the FACT-An at each scheduled visit were summarized for each treatment group. The denominator for the percentage calculation per treatment group was based on the number of the FACT-An evaluable population at baseline. The distribution of change in responses (improved [i.e., change score from 1 to 4], no change [0], worsened by one level [-1], worsened by ≥2 levels [-2 to -4], and missing) from baseline at each post-baseline scheduled visit were summarized by treatment group."|From Baseline to Cycle 3 Day 1 (C3D1)|The HRQoL evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score baseline visit and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661810|NCT01566695|Secondary|Percentage of Participants With Change From Baseline in Responses to the Fact-Anemia Item GP-5|"The distribution (frequency and percentage) of the observed responses (i.e., Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4), and missing) to Item GP-5 (I am bothered by side effects of treatment in the past seven days) of the FACT-An at each scheduled visit were summarized for each treatment group. The denominator for the percentage calculation per treatment group was based on the number of the FACT-An evaluable population at baseline. The distribution of change in responses (improved [i.e., change score from 1 to 4], no change [0], worsened by one level [-1], worsened by ≥2 levels [-2 to -4], and missing) from baseline at each post-baseline scheduled visit were summarized by treatment group."|From Baseline to Cycle 2 Day 1 (C2D1)|The HRQoL evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score baseline visit and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661811|NCT01566695|Secondary|Percentage of Participants With a Clinically Meaningful Improvement (CMI) From Baseline in the Functional Assessment of Cancer Therapy Anemia-Total Score Domain Within the FACT-An Instrument at Cycle 6|A clinically meaningful improvement or deterioration was defined by domain specific thresholds of change from baseline. The FACT-An questionnaire is a 47-item, cancer specific questionnaire consisting of a core 27 items measuring 4 general domains physical well being, social/family, emotional well being and Functional Well-Being and an additional 20-item anemia questionnaire that measures fatigue and 7 non-fatigue items. The scales are formatted on 4 pages for self-administration using a 5-point Likert rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a Bit and 4 = Very much). Also, general HRQoL measures the impact of fatigue and other anemia-related symptoms on patient functioning and is used to assess the effect of treatments in various areas, including MDS. The instrument and the fatigue and non-fatigue subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 = the poorest QOL and 100 = the highest QOL.|Cycle 6 Day 1|Health Related Quality of Life (HR-QoL) evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score at C1D1 and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661812|NCT01566695|Secondary|Percentage of Participants With a Clinically Meaningful Improvment (CMI) From Baseline in the Functional Assessment of Cancer Therapy-Anemia-General Subscale Domain Within the FACT-An Instrument at Cycle 6|A clinically meaningful improvement or deterioration was defined by domain specific thresholds of change from baseline. The FACT-An questionnaire is a 47-item, cancer specific questionnaire consisting of a core 27 items measuring 4 general domains physical well being, social/family, emotional well being and Functional Well-Being and an additional 20-item anemia questionnaire that measures fatigue and 7 non-fatigue items. The scales are formatted on 4 pages for self-administration using a 5-point Likert rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a Bit and 4 = Very much). Also, general HRQoL measures the impact of fatigue and other anemia-related symptoms on patient functioning and is used to assess the effect of treatments in various areas, including MDS. The instrument and the fatigue and non-fatigue subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 = the poorest QOL and 100 = the highest QOL.|Cycle 6 Day 1|The HRQoL evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score baseline visit and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661917|NCT01566461|Secondary|Major Target Limb Amputation||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
2661813|NCT01566695|Secondary|Percentage of Participants With a Clinically Meaningful Improvment (CMI) From Baseline in the Functional Assessment of Cancer Therapy-Anemia Trial Outcome Index Subscale Domain Within the FACT-An Instrument at Cycle 6|A clinically meaningful improvement or deterioration was defined by domain specific thresholds of change from baseline. The FACT-An questionnaire is a 47-item, cancer specific questionnaire consisting of a core 27 items measuring 4 general domains physical well being, social/family, emotional well being and Functional Well-Being and an additional 20-item anemia questionnaire that measures fatigue and 7 non-fatigue items. The scales are formatted on 4 pages for self-administration using a 5-point Likert rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a Bit and 4 = Very much). Also, general HRQoL measures the impact of fatigue and other anemia-related symptoms on patient functioning and is used to assess the effect of treatments in various areas, including MDS. The instrument and the fatigue and non-fatigue subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 = the poorest QOL and 100 = the highest QOL.|Cycle 6 Day 1|Health Related Quality of Life (HR-QoL) evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score at C1D1 and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661814|NCT01566695|Secondary|Percentage of Participants With a Clinically Meaningful Improvment (CMI) From Baseline in the Fatigue Related Symptoms Subscale Domain Within the FACT-An Instrument at Cycle 6|A clinically meaningful improvement or deterioration was defined by domain specific thresholds of change from baseline. The FACT-An questionnaire is a 47-item, cancer specific questionnaire consisting of a core 27 items measuring 4 general domains physical well being, social/family, emotional well being and Functional Well-Being and an additional 20-item anemia questionnaire that measures fatigue and 7 non-fatigue items. The scales are formatted on 4 pages for self-administration using a 5-point Likert rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a Bit and 4 = Very much). Also, general HRQoL measures the impact of fatigue and other anemia-related symptoms on patient functioning and is used to assess the effect of treatments in various areas, including MDS. The instrument and the fatigue and non-fatigue subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 = the poorest QOL and 100 = the highest QOL.|Cycle 6 Day 1|Health Related Quality of Life (HR-QoL) evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score at C1D1 and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661815|NCT01566695|Secondary|Percentage of Participants With a Clinically Meaningful Improvment (CMI) From Baseline on the Anemia Subscale Domain Within the FACT-An Instrument at Cycle 6|A clinically meaningful improvement or deterioration was defined by domain specific thresholds of change from baseline. The FACT-An questionnaire is a 47-item, cancer specific questionnaire consisting of a core 27 items measuring 4 general domains physical well being, social/family, emotional well being and Functional Well-Being and an additional 20-item anemia questionnaire that measures fatigue and 7 non-fatigue items. The scales are formatted on 4 pages for self-administration using a 5-point Likert rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a Bit and 4 = Very much). Also, general HRQoL measures the impact of fatigue and other anemia-related symptoms on patient functioning and is used to assess the effect of treatments in various areas, including MDS. The instrument and the fatigue and non-fatigue subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 = the poorest QOL and 100 = the highest QOL.|Cycle 6 Day 1|Health Related Quality of Life (HR-QoL) evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score at C1D1 and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661816|NCT01566695|Secondary|Percentage of Participants With a Clinically Meaningful Improvment (CMI) From Baseline on the Functional Well-Being Domain Within the FACT-An Instrument at Cycle 6|A clinically meaningful improvement or deterioration was defined by domain specific thresholds of change from baseline. The FACT-An questionnaire is a 47-item, cancer specific questionnaire consisting of a core 27 items measuring 4 general domains physical well being, social/family, emotional well being and Functional Well-Being and an additional 20-item anemia questionnaire that measures fatigue and 7 non-fatigue items. The scales are formatted on 4 pages for self-administration using a 5-point Likert rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a Bit and 4 = Very much). Also, general HRQoL measures the impact of fatigue and other anemia-related symptoms on patient functioning and is used to assess the effect of treatments in various areas, including MDS. The instrument and the fatigue and non-fatigue subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 = the poorest QOL and 100 = the highest QOL.|Cycle 6 Day 1|Health Related Quality of Life (HR-QoL) evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score at C1D1 and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661817|NCT01566695|Secondary|Percentage of Participants With a Clinically Meaningful Improvment (CMI) From Baseline on the Emotional Well-Being Domain Within the FACT-An Instrument at Cycle 6|A clinically meaningful improvement or deterioration was defined by domain specific thresholds of change from baseline. The FACT-An questionnaire is a 47-item, cancer specific questionnaire consisting of a core 27 items measuring 4 general domains physical well being, social/family, emotional well being and Functional Well-Being and an additional 20-item anemia questionnaire that measures fatigue and 7 non-fatigue items. The scales are formatted on 4 pages for self-administration using a 5-point Likert rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a Bit and 4 = Very much). Also, general HRQoL measures the impact of fatigue and other anemia-related symptoms on patient functioning and is used to assess the effect of treatments in various areas, including MDS. The instrument and the fatigue and non-fatigue subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 = the poorest QOL and 100 = the highest QOL.|Cycle 6 Day 1|Health Related Quality of Life (HR-QoL) evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score at C1D1 and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661918|NCT01566461|Secondary|Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)|Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post procedure baseline.|12 month|Includes all subjects who experienced a CD-TLR.|||Days||Standard Deviation|Mean
2661818|NCT01566695|Secondary|Percentage of Participants With a Clinically Meaningful Improvment (CMI) From Baseline on the Social Well-Being Domain Within the FACT-An Instrument at Cycle 6|A clinically meaningful improvement or deterioration was defined by domain specific thresholds of change from baseline. The FACT-An questionnaire is a 47-item, cancer specific questionnaire consisting of a core 27 items measuring 4 general domains physical well being, social/family, emotional well being and Functional Well-Being and an additional 20-item anemia questionnaire that measures fatigue and 7 non-fatigue items. The scales are formatted on 4 pages for self-administration using a 5-point Likert rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a Bit and 4 = Very much). Also, general HRQoL measures the impact of fatigue and other anemia-related symptoms on patient functioning and is used to assess the effect of treatments in various areas, including MDS. The instrument and the fatigue and non-fatigue subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 = the poorest QOL and 100 = the highest QOL.|Cycle 6 Day 1|Health Related Quality of Life (HR-QoL) evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score at C1D1 and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661819|NCT01566695|Secondary|Percentage of Participants With a Clinically Meaningful Improvment (CMI) From Baseline on the Physical Well-Being Domain Within the FACT-An Instrument at Cycle 6|A clinically meaningful improvement or deterioration was defined by domain specific thresholds of change from baseline. The FACT-An questionnaire is a 47-item, cancer specific questionnaire consisting of a core 27 items measuring 4 general domains physical well being, social/family, emotional well being and Functional Well-Being and an additional 20-item anemia questionnaire that measures fatigue and 7 non-fatigue items. The scales are formatted on 4 pages for self-administration using a 5-point Likert rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a Bit and 4 = Very much). Also, general HRQoL measures the impact of fatigue and other anemia-related symptoms on patient functioning and is used to assess the effect of treatments in various areas, including MDS. The instrument and the fatigue and non-fatigue subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 = the poorest QOL and 100 = the highest QOL.|Cycle 6 Day 1|Health Related Quality of Life (HR-QoL) evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score at C1D1 and at least one post-baseline assessment visit.|||Percentage of Participants|||Number
2661820|NCT01566695|Secondary|Mean Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia-Total Score at Cycle 6|"The FACT-G and the anemia subscale (AnS) are summed to form the FACT-An total score and the total score ranges from 0 to 188. The FACT-G measures the 4 domains on a 5-point scale ranging from 0 (not at all) to 4 (very much). The 4 domains are:~Physical Well-being (PWB; 7 items; score range, 0-28),~Social/Family Well-being (SWB; 7 items; score range, 0-28),~Emotional Well-being (EWB; 6 items; score range, 0-24), and~Functional Well-being (7 items; score range, 0-28). The AnS consists of 20 items on the same 5-point scale, with 13 of them measuring fatigue-related symptoms (FS) and 7 measuring non-FS. The AnS and FS scores can range from 0-80 and 0-52, respectively. For all domains and summary subscales, a higher score indicates better HRQoL or lower level of symptoms."|Baseline to Cycle 6 Day 1|Health Related Quality of Life (HR-QoL) evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score at C1D1 and at least one post-baseline assessment visit.|||Units on a Scale||Standard Deviation|Mean
2661821|NCT01566695|Secondary|Mean Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia-General (FACT-G) Summary Scale Within the FACT-An Instrument at Cycle 6|"The FACT-An is a 47-item, cancer-specific questionnaire consisting of a core 27-item general questionnaire (i.e., the Functional Assessment of Cancer Therapy-General [FACT-G]) The FACT-G measures the 4 domains on a 5-point scale ranging from 0 (not at all) to 4 (very much). The 4 domains are:~Physical Well-being (PWB; 7 items; score range, 0-28),~Social/Family Well-being (SWB; 7 items; score range, 0-28),~Emotional Well-being (EWB; 6 items; score range, 0-24), and~Functional Well-being (7 items; score range, 0-28). The FACT-G is a summation composed of a summary scale including the PWB, SWB, EWB and FWB. The FACT-G score range is from 0 to 108. For all summary scales including FACT-G, a higher score indicates better HRQoL or lower level of symptoms."|Baseline to Cycle 6 Day 1|Health Related Quality of Life (HR-QoL) evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score at C1D1 and at least one post-baseline assessment visit.|||Units on a Scale||Standard Deviation|Mean
2661822|NCT01566695|Secondary|Mean Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia Trial Outcome Index (FACT-An TOI) Summary Scale Within the FACT-An Instrument at Cycle 6|"The FACT-G and FACT-An score are summed to form the FACT-An total score. The FACT-An Trial Outcome Index (TOI) consists of the summation of a summary scale and includes the Physical Well-being, (PWB; 7 items; score range, 0-28), the Functional Well-being (7 items; score range, 0-28) and the Anemia subscale consisting of 20 items on the same five-point scale, with 13 of them measuring fatigue related symptoms (FS) and seven measuring non-FS. The FACT-An TOI has been demonstrated to be a sensitive indicator of clinical outcomes in a number of diseases including MDS. The Fact-TOI score ranges from 0 to 136. Higher scores on all scales of the Fact-An and subscales on the FACT-TOI reflect better quality of life or fewer symptoms."|Baseline to Cycle 6 Day 1|Health Related Quality of Life (HR-QoL) evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score at C1D1 and at least one post-baseline assessment visit.|||Units on a Scale||Standard Deviation|Mean
2661836|NCT01566695|Secondary|Percentage of Participants Who Achieved Platelet Transfusion Independence With a Duration of ≥ 8 Weeks (56 Days)|"Platelet transfusion independence was defined as the absence of any platelet transfusion during any consecutive rolling 56 days during the treatment period, (ie, Day 1 to 56, Day 2 to 57, Days 3 to 58, etc.). Participants were considered platelet transfusion dependent at baseline if they had received ≥ 2 platelet transfusions during the 56 days immediately preceding randomization and had no consecutive 28-day period during which no platelet transfusions were administered."|From the date of randomization of study drug up to the treatment period; up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo|ITT population; includes participants were were platelet transfusion dependent.|||Percentage Participants|||Number
2661919|NCT01566461|Secondary|Target Lesion Revascularization (TLR)||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
2661823|NCT01566695|Secondary|Mean Change From Baseline in the Fatigue-Related Subscale Within the FACT-An Instrument at Cycle 6|The FACT-An questionnaire is a 47-item, cancer specific questionnaire consisting of a core 27 items measuring 4 general domains physical well being (PWG), social/family (SWB), emotional well being (EWB) and Functional Well-Being (FWB) and an additional 20-item anemia questionnaire that measures fatigue associated items and 7 non-fatigue items. The scales are formatted on 1 to 4 pages for self-administration using a 5-point Likert rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a Bit and 4 = Very much). Also, general health related quality of life (HRQoL), the FACT-An measures the impact of fatigue and other anemia-related symptoms on patient functioning and is used to assess the effect of treatments in various therapeutic areas, including MDS. The instrument and the fatigue and non-fatigue subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 indicates the poorest QOL and 100 denotes the highest QOL.|Baseline to Cycle 6 Day 1|Health Related Quality of Life (HR-QoL) evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score at C1D1 and at least one post-baseline assessment visit.|||Units on a Scale||Standard Deviation|Mean
2661824|NCT01566695|Secondary|Mean Change From Baseline in the Anemia Subscale Within FACT-An Instrument at Cycle 6|The FACT-An questionnaire is a 47-item, cancer specific questionnaire consisting of a core 27 items measuring 4 general domains physical well being (PWG), social/family (SWB), emotional well being (EWB) and Functional Well-Being (FWB) and an additional 20-item anemia questionnaire that measures fatigue associated items and 7 non-fatigue items. The scales are formatted on 1 to 4 pages for self-administration using a 5-point Likert rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a Bit and 4 = Very much). Also, general health related quality of life (HRQoL), the FACT-An measures the impact of fatigue and other anemia-related symptoms on patient functioning and is used to assess the effect of treatments in various therapeutic areas, including MDS. The instrument and the fatigue and non-fatigue subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 indicates the poorest QOL and 100 denotes the highest QOL.|Baseline to Cycle 6 Day 1|Health Related Quality of Life (HR-QoL) evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score at C1D1 and at least one post-baseline assessment visit.|||Units on a Scale||Standard Deviation|Mean
2661825|NCT01566695|Secondary|Mean Change From Baseline in the Functional Well-Being Component of the FACT-An Instrument at Cycle 6|The FACT-An questionnaire is a 47-item, cancer specific questionnaire consisting of a core 27 items measuring 4 general domains physical well being (PWG), social/family (SWB), emotional well being (EWB) and Functional Well-Being (FWB) and an additional 20-item anemia questionnaire that measures fatigue associated items and 7 non-fatigue items. The scales are formatted on 1 to 4 pages for self-administration using a 5-point Likert rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a Bit and 4 = Very much). Also, general health related quality of life (HRQoL), the FACT-An measures the impact of fatigue and other anemia-related symptoms on patient functioning and is used to assess the effect of treatments in various therapeutic areas, including MDS. The instrument and the fatigue and non-fatigue subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 indicates the poorest QOL and 100 denotes the highest QOL.|Baseline to Cycle 6 Day 1|The FACT-Anemia evaluable population was defined as all ITT participants with a non-missing FACT-An Trial Outcome Index (TOI) score at C1D1 and at least one post-baseline assessment visit.|||Units on a Scale||Standard Deviation|Mean
2661826|NCT01566695|Secondary|Mean Change From Baseline in the Emotional Well-Being Component of the Functional Assessment of Cancer Therapy-Anemia Instrument at Cycle 6|The FACT-An questionnaire is a 47-item, cancer specific questionnaire consisting of a core 27 items measuring 4 general domains physical well being (PWG), social/family (SWB), emotional well being (EWB) and Functional Well-Being (FWB) and an additional 20-item anemia questionnaire that measures fatigue associated items and 7 non-fatigue items. The scales are formatted on 1 to 4 pages for self-administration using a 5-point Likert rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a Bit and 4 = Very much). Also, general health related quality of life (HRQoL), the FACT-An measures the impact of fatigue and other anemia-related symptoms on patient functioning and is used to assess the effect of treatments in various therapeutic areas, including MDS. The instrument and the fatigue and non-fatigue subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 indicates the poorest QOL and 100 denotes the highest QOL.|Baseline to Cycle 6 Day 1|The Health Related Quality of Life (HR-QoL) evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score at C1D1 and at least one post-baseline assessment visit.|||Units on a Scale||Standard Deviation|Mean
2661827|NCT01566695|Secondary|Mean Change From Baseline in the Social Well-Being Component of the Functional Assessment of Cancer Therapy-Anemia Instrument at Cycle 6|The FACT-An questionnaire is a 47-item, cancer specific questionnaire consisting of a core 27 items measuring 4 general domains physical well being (PWG), social/family (SWB), emotional well being (EWB) and Functional Well-Being (FWB) and an additional 20-item anemia questionnaire that measures fatigue associated items and 7 non-fatigue items. The scales are formatted on 1 to 4 pages for self-administration using a 5-point Likert rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a Bit and 4 = Very much). Also, general health related quality of life (HRQoL), the FACT-An measures the impact of fatigue and other anemia-related symptoms on patient functioning and is used to assess the effect of treatments in various therapeutic areas, including MDS. The instrument and the fatigue and non-fatigue subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 indicates the poorest QOL and 100 denotes the highest QOL.|Baseline to Cycle 6 Day 1|The Health Related Quality of Life (HR-QoL) evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score at C1D1 and at least one post-baseline assessment visit.|||Units on a Scale||Standard Deviation|Mean
2661863|NCT01566630|Primary|Number of Patients With Adverse Events, Serious Adverse and Death During Part 1 of the Study|Safety and tolerability was assessed by adverse events/serious adverse event and death monitoring.|Prior to delivery until 4-6 weeks post partum (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed.|||Participants|||Number
2661920|NCT01566461|Secondary|Target Vessel Revascularization (TVR)||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
2661828|NCT01566695|Secondary|Mean Change From Baseline in the Physical Well-Being Component of the Functional Assessment of Cancer Therapy-Anemia (FACT-An) Endpoints at Cycle 6|The FACT-An questionnaire is a 47-item, cancer specific questionnaire consisting of a core 27 items measuring 4 general domains physical well being (PWG), social/family (SWB), emotional well being (EWB) and Functional Well-Being (FWB) and an additional 20-item anemia questionnaire that measures fatigue associated items and 7 non-fatigue items. The scales are formatted on 1 to 4 pages for self-administration using a 5-point Likert rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a Bit and 4 = Very much). Also, general health related quality of life (HRQoL), the FACT-An measures the impact of fatigue and other anemia-related symptoms on patient functioning and is used to assess the effect of treatments in various therapeutic areas, including MDS. The instrument and the fatigue and non-fatigue subscales are scored by summing points from all questions, then converting this sum to a 100 point scale; 0 indicates the poorest QOL and 100 denotes the highest QOL.|Baseline to Cycle 6 Day 1|The Health Related Quality of Life (HR-QoL) evaluable population was defined as participants with a non-missing FACT-An Trial Outcome Index (TOI) score at C1D1 and at least one post-baseline assessment visit.|||Units on a Scale||Standard Deviation|Mean
2661829|NCT01566695|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|"A TEAE was defined as an adverse event that begins or worsens in intensity of frequency on or after the first dose of study drug through 28 days after last dose of study drug.~A serious adverse event (SAE) is any:~Death;~Life-threatening event;~Any inpatient hospitalization or prolongation of existing hospitalization;~Persistent or significant disability or incapacity;~Congenital anomaly or birth defect;~Any other important medical event The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death."|From first dose of IP up to 28 days after the last dose of IP; up to data cut-off date of 25 Jan 2019; median duration of treatment to oral azacitaidine was 5.29 months and 5.36 months for placebo|The safety population includes all randomized participants who received at least one dose of study drug.|||Participants|||Count of Participants
2661830|NCT01566695|Secondary|Percentage of Participants With Significant Bleeding Events|Clinically significant bleeding event was defined as: any intracranial or retroperitoneal bleed; bleeding requiring transfusions of > 2 units of blood/blood products; bleeding associated with a decrease in hemoglobin of > 2 g/dL; or bleeding from any site requiring transfusions of > 2 units of blood.|From date of randomization until 28 days after the last dose of IP; up to data cut off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo|The intent-to-treat (ITT) population included all participants who were randomized, regardless of whether they received treatment or not.|||Percentage of Participants|||Number
2661831|NCT01566695|Secondary|Time to Progression to Acute Myeloid Leukemia (AML) Among Participants Who Progressed to AML|"Time to AML progression was defined as the time from the date of randomization until the date the subject has documented progression to AML. For participants who had progression to AML documented in MLL central lab report, the earliest sample collection date with the diagnosis of s-AML arising from previous MDS was used as the date to AML progression."|From randomization of study drug to progression of AML; up to final data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo|The intent-to-treat (ITT) population who progressed to AML.|||Months||Full Range|Median
2661832|NCT01566695|Secondary|Percentage of Participants Who Progressed to Acute Myeloid Leukemia (AML)|Participants with a documented diagnosis of AML arising from previous MDS documented diagnosis.|From randomization of study drug to the end up to final data cut-off date of 25 January 2019; maximum follow-up time was 67.9 months for azacitidine and 64.8 months for placebo group|The intent-to-treat (ITT) population included all participants who were randomized, regardless of whether they received treatment or not.|||Percentage of Participants|||Number
2661833|NCT01566695|Secondary|Percentage of Participants With a Hematologic Response According to the 2006 IWG Criteria for MDS|"Hematologic response was defined as:~A complete response (CR): <5% myeloblasts, and normal maturation of all cell lines; Peripheral blood (PB) shows: hemoglobin >10 g/dL, neutrophils ≥1.0x10^9/L, platelets ≥100x10^9/dL, blasts (0%)~Partial Response (PR): same as CR bone marrow (BM) shows blasts decreased by ≥ 50% over pre-treatment but still > 5%; Cellularity and morphology not relevant~Marrow CR: BM: ≤ 5% myeloblasts and decrease by ≥ 50% over pre-treatment PB~Stable disease (SD): failure to achieve at least PR, but no evidence of progression for > 8 wks~Failure: death during treatment or disease progression~Disease Progression for those with:~Less than 5% blasts: ≥ 50% increase in blasts to > 5% blasts~5%-10% blasts:≥ 50% increase to > 10% blasts~10%-20% blasts:≥ 50% increase to > 20% blasts~20%-30% blasts ≥ 50% increase to > 30% blasts~Any of the following:~≥ 50% decrease from maximum remission/response in granulocytes or platelets"|Response was assessed every 3 cycles; up to the data cut-off date of 25 Jan 2019; median duration of exposure to oral azacitidine was 86.0 days and 119.0 days for placebo|Population includes participants with a CR, PR and mCR who had baseline bone marrow blasts > 5%. ITT population.|||Percentage of Participants|||Number
2661834|NCT01566695|Secondary|Kaplan-Meier Estimate of Overall Survival (OS)|Overall survial was defined as the time from randomization to death from any cause, and was calculated using randomization date and date of death, or date of last follow-up for censored participants. All subjects were followed until drop out (withdrawal of consent from further data collection or lost to follow-up), death, or study closure. Participants who dropped out or were alive at study closure (or at the time of the interim analysis) had their OS times censored at the time of last contact, as appropriate. Overall survival was assessed as an interim analysis at the time of the primary analysis.|From randomization to death from any cause; up to the data cut-off of date of 25 January 2019; maximum follow-up time for all participants was 67.9 months for the oral azacitidine arm and 64.8 months for placebo arm||2022-12-31|12/2022||||
2661913|NCT01566461|Secondary|Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4)||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
2661837|NCT01566695|Secondary|Percentage of Participants With a Hematological Improvement Response in Platelets (HI-P) According to 2006 IWG Criteria|HI-P response was defined according to IWG 2006 criteria (Cheson, 2006) and as: 1. Absolute increase of ≥ 30 X 10^9/L for participants^ starting with > 20 X 10^9/L platelets; 2. Increase from < 20 X 10^9/L to > 20 X 10^9/L and by at least 100%. HI-P must have lasted at least 8 weeks.|From the date of randomization of study drug up to the treatment period; up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo|The ITT population included all participants who were randomized, regardless of whether they received treatment or not.|||Percentage of Participants||95% Confidence Interval|Number
2661838|NCT01566695|Secondary|Percentage of Participants With an Erythroid Hematological Improvement (HI-E) Response According to 2006 IWG Criteria|Erythroid HI-E improvement was defined as a hemoglobin increase of ≥ 1.5 g/dL; or a reduction in units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks. Only RBC transfusions given for a hemoglobin of ≤ 9.0 g/dL on treatment were counted in the RBC transfusion response evaluation.|From the date of randomization of study drug up to the treatment period; up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo|The ITT population included all participants who were randomized, regardless of whether they received treatment or not.|||Percentage of Participants||95% Confidence Interval|Number
2661839|NCT01566695|Secondary|Time to RBC Transfusion Independence for at Least 84 Days Among Participants Who Achieved RBC Transfusion Independence for at Least 84 Days|Time to RBC transfusion independence of ≥ 84 days was defined as the time between randomization and the date onset of transfusion independence was first observed (ie, Day 1 of 84 without any RBC transfusions).|From the date of randomization of study drug up to the treatment period; up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo|Participants who achieved a 84-day TI response. Responders in the intent to treat population.|||Months||Full Range|Median
2661840|NCT01566695|Secondary|Duration of RBC Transfusion Independence Among Participants Who Achieved RBC Transfusion Independence for at Least 84 Days|Duration of RBC transfusion independence was analyzed only for participants who achieved RBC transfusion independence of ≥ 84 days on treatment. Duration of RBC transfusion independence was defined as the time from the date transfusion independence is first observed (day 1 of a ≥ 84 days period without a transfusion) until the date the participants had a subsequently documented RBC transfusion. In case a participant had more than one ≥84 days rolling periods which met the RBC independence criteria, the duration with the longest rolling period was used in the analysis.|From the date of randomization of study drug up to the treatment period; up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo|Intent to Treat population. Participants who achieved RBC transfusion independence for at least 84 days on treatment.|||months||95% Confidence Interval|Median
2661841|NCT01566695|Secondary|Percentage of Participants Who Achieved Red Blood Cell Transfusion Independence for ≥ 84 Days|"RBC transfusion independence was defined as the absence of any RBC transfusion during any consecutive rolling 84 days within the treatment period. Participants who did not receive any RBC transfusion during a consecutive rolling 84 days (i.e., day 1 to day 84, day 2 to day 85) were considered as a 84-day RBC transfusion independent responder."|From the date of randomization of study drug up to the treatment period; up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo|The ITT population includes all participants who were randomized, regardless of whether they received treatment or not.|||Percentage of Participants||95% Confidence Interval|Number
2661842|NCT01566695|Secondary|Duration of RBC Transfusion Reduction for Participants Who Achieved RBC Transfusion Reduction of at Least 4 Units of RBCs for at Least 8 Weeks|A participant was considered as a RBC transfusion reduction responder if the participant had at least 4 units reduction in transfusion units over any consecutive 56 days period compared to the baseline transfusion units in 56 days.|From the date of randomization of study drug up to the treatment period; up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo|Intent to Treat population; includes participants who achieved RBC transfusion reduction of at least 4 units for at least 8 weeks.|||months||95% Confidence Interval|Median
2661843|NCT01566695|Secondary|Time to RBC Transfusion Independence for at Least 56 Days Among Participants Who Achieved RBC Transfusion Independence for at Least 56 Days|Time to RBC transfusion independence of ≥ 56 days was defined as the time between randomization and the date onset of transfusion independence was first observed (ie, Day 1 of 56 without any RBC transfusions).|From the date of randomization of study drug up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo|Participants who achieved a 56-day TI response. Responders in the intent to treat population.|||Months||Full Range|Median
2661844|NCT01566695|Secondary|Duration of RBC Transfusion Independence Among Participants Who Achieved RBC Transfusion Independence for at Least 56 Days|Duration of RBC transfusion independence was analyzed only for participants who achieved RBC transfusion independence of ≥ 56 days on treatment. Duration of RBC transfusion independence was defined as the time from the date transfusion independence is first observed (day 1 of a ≥ 56 days period without a transfusion) until the date the participants had a subsequently documented RBC transfusion. In the event a participant had more than one ≥56 days rolling periods which met the RBC independence criteria, the duration with the longest rolling period was used in the analysis. Participants who maintained RBC TI through the end of the treatment period were censored at the date of treatment discontinuation, death, or 1 day before the start of the subsequent MDS treatment (if any), whichever occurred first, or the particiapnts latest available assessment date in the database if the treatment was still on-going.|From the date of randomization of study drug up to the data cut-off date of 25 January 2019; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo|Intent to Treat population. Participants who achieved RBC transfusion independence of ≥ 56 days on treatment.|||months||95% Confidence Interval|Median
2661914|NCT01566461|Secondary|Secondary Sustained Clinical Improvement|Freedom from target amputation and increase in Rutherford class.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of particpants|||Number
2661845|NCT01566695|Primary|Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for ≥ 56 Days|"RBC transfusion (tfx) independence was defined as the absence of any RBC transfusion during any consecutive rolling 56 days within the treatment period. Participants who did not receive any RBC transfusion during a consecutive rolling 56 days (i.e., day 1 to day 56, day 2 to day 57) were considered as a 56-day RBC transfusion independent responder."|Each participant was assessed for at least 56 days or more; from the date of randomization of study drug up to the data cut-off date of 25 January 2019, approximately 5 months.|The intent-to-treat (ITT) population included all participants who were randomized, regardless of whether they received treatment or not.|||Percentage of Participants||95% Confidence Interval|Number
2661846|NCT01566682|Primary|Clinical Efficacy in the Risk Stratification of Patients With Indeterminate Lesions|Demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer.|The ProLung Test will be performed within 60 days of a CT Scan that identifies a lung lesion suspicious for lung cancer and evaluated once a patient diagnosis is obtained.|Validation set of patients with indeterminate lung nodules|||percentage||95% Confidence Interval|Number
2661847|NCT01566630|Secondary|Mean Number of Days Before Delivery||From randomization until delivery (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
2661848|NCT01566630|Primary|Pharmacokinetics of RLX030: Mean Residence Time (MRT)|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
2661849|NCT01566630|Primary|Pharmacokinetics of RLX030: Terminal Elimination Half-life (T1/2)- Part 1|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
2661850|NCT01566630|Primary|Pharmacokinetics of RLX030: Blood Concentration at 24 Hour (C 0-24h) After Administration- Part 1|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
2661851|NCT01566630|Primary|Pharmacokinetics of RLX030: Area Under the Blood Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)-Part 1|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
2661852|NCT01566630|Primary|Pharmacokinetics of RLX030: Area Under the Blood Concentration-time Curve From Time Zero to Infinity (AUCinf)-Part 1|Blood concentrations of RLX-030 was assayed to determine this PK parameter.|Baseline, 2, 6, 24,48,72, 76, 80 and 90 hours after initiation of infusion during part 1|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
2661853|NCT01566630|Primary|Number of Patients With Abnormalities in Fetal Cardiotocography and Biophysical Profile||Randomization to delivery (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
2661854|NCT01566630|Primary|Number of Patients With Abnormalities in Birth Weight, Gestational Age, Appearance, Pulse, Grimace, Activity, Respiration (APGAR) Score, Umbilical Cord Gases, and Days in Neonatal Intensive Care Unit (NICU)||up to 4 - 6 weeks post partum (maximum of 8 weeks )|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
2661855|NCT01566630|Primary|Number of Patients With Absence of Anti-serelaxin Antibodies||From Randomization until 4-6 weeks post partum (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
2661856|NCT01566630|Primary|Rate of Spontaneous Delivery and/or Mode of Delivery||From randomization to delivery (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
2661857|NCT01566630|Primary|Improvement in Renal Function Assessed by Increase in Creatinine Clearance||From randomization until 4-6 weeks post partum (maximum 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
2661858|NCT01566630|Primary|Change in Fetal Heart Rate (Part 1)|Heart rate of fetus was monitored continuously throughout 72 hour treatment period using a cardiotocograph.|During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
2661859|NCT01566630|Primary|Decrease in Utero-placental Blood Flow (Part 1)|Blood flow to the fetus was monitored using via a Doppler.|During treatment period of a maximum 72 hours infusion prior to delivery and up to delivery in part 1 (maximum of 3 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
2661860|NCT01566630|Primary|Change From Baseline on Maternal Proteinuria (Part 1)|Pre-eclampsia was monitored by checking levels of protein in urine and by urinary protein/creatinine ratio (UPCR)|From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
2661861|NCT01566630|Primary|Change From Baseline in Mean Maternal Arterial Pressure (Part 1)|Maternal safety assessment to monitor pre-eclampsia by checking mean arterial pressure during 72 hour treatment period as well as post-dose.|From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
2661862|NCT01566630|Primary|Change From Baseline in Maternal Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in Part 1of the Study (Part 1)|Maternal safety assessment to monitor pre-eclampsia by checking blood pressure during 72 hour treatment period as well as post-dose.|From baseline to during treatment period of a maximum 72 hours infusion prior to delivery until 4-6 weeks post partum in part 1 (maximum of 8 weeks)|No formal analysis was performed as the study was terminated after three patients were enrolled and dosed||||||
2661864|NCT01566604|Secondary|The Total Score of the St George's Respiratory Questionnaire (SGRQ)|SGRQ is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity and impacts. The lowest possible score is zero and the highest possible score is 100. Higher scores correspond to greater impairment in quality of life. The health-related quality of life was measured using SGRQ. It was completed by the participant at the investigators site.|Week 12, week 26|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12 or week 26.|||Score||Standard Error|Least Squares Mean
2661865|NCT01566604|Secondary|Number of Moderate and Severe COPD Exacerbations|COPD exacerbations were recorded in the patient diary and other source documents. The rate of COPD exacerbations during the 26 week treatment period was analyzed using a generalized linear model assuming a negative binomial distribution.|26 weeks|Full Analysis Set: The full analysis set included all randomized patients who received at least one dose of study medication.|||Number of exacerbations||Standard Deviation|Mean
2661866|NCT01566604|Secondary|Time to First Moderate or Severe COPD Exacerbation|A COPD exacerbation was defined as a worsening of the following two or more major symptoms for at least 2 consecutive days:1) dyspnea; 2) sputum volume; 3) sputum purulence; or defined as a worsening of any 1 major symptom together with an increase in any 1 of the following minor symptoms for at least 2 consecutive days: 1) sore throat; 2) colds (nasal discharge and/or nasal congestion); 3) fever without other cause; 4) cough; 5) wheeze. COPD exacerbations were recorded in the patient diary and other source documents.|26 weeks|Full Analysis Set: The full analysis set included all randomized patients who received at least one dose of study medication.|||Days||Full Range|Median
2661867|NCT01566604|Secondary|Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptoms (Cough, Wheezing, Shortness of Breath, Sputum Volume, Sputum Color and Night Time Awakenings)|In an electronic diary, the participant responded to 6 questions twice daily to report on the degree of symptoms over the past 12 hours of the morning and evening. The questions covered the participant's degree of overall symptoms, and degrees of individual symptoms of coughing, wheezing, amount of sputum, color of sputum and breathlessness. Each question scored from 0 to 3 where 0 represented no symptom present and 3 represented the worst degree of that symptom. A negative change in symptom score indicates improvement.|Baseline, 26 weeks|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given symptom category, analyzed participants had both baseline and week 26 values.|||score||Standard Error|Least Squares Mean
2661868|NCT01566604|Secondary|Standardized FEV1 Area Under the Curve (AUC(5 Min-4 h)) Post-dose|The standardized (with respect to time) AUC for FEV1 was calculated between 5 min and 4h post morning dose at day 1, week 12 and week 26. The AUC (5 min-4 h) for FEV1 at each visit was analyzed using the same MIXED model as specified for the primary analysis.|Day 1, week 12, week 26|The number of participants considered for the analysis was from a Serial Spirometry subgroup of the full analysis set where N = 134 and 58, respectively. However, analyzed participants had values at both baseline and the corresponding time frame, i.e. day 1, week 12 or week 26.|||Liters||Standard Error|Least Squares Mean
2661869|NCT01566604|Secondary|Peak FEV1|Peak FEV1 was defined as the maximum FEV1 0-4 h post-dose. Peak Fev1 was measured at 45min and 15min pre-dose and up to 4h post dose at day 1, week 12 and week 26, using central spirometry according to ATS/ERS standardization. It was analyzed using the same MIXED model as specified for the primary analysis.|Day 1, week 12, week 26|The number of participants considered for the analysis was from a Serial Spirometry subgroup of the full analysis set where N = 134 and 58, respectively. However, analyzed participants had values at both baseline and the corresponding time frame, i.e. day 1, week 12 or week 26.|||Liters||Standard Error|Least Squares Mean
2661870|NCT01566604|Secondary|FEV1 and Forced Vital Capacity (FVC)|FEV1 and FVC were measured using central spirometry according to ATS/ERS standardization. Both were analyzed using the same MIXED model as specified for the primary analysis.|Day 1 at 5, 15, 30 minutes (min) and 1 hour (h) post dose; days 2, 86, 184 at 23 (h) 15 min and 23 h 45 min post dose; days 29, 85, 183 at -45 and -15 min pre-dose and 5, 15, and 30 min post dose|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, e.g. day 1, 5 min; day 1, 15 min, etc..|||Liters||Standard Error|Least Squares Mean
2661871|NCT01566604|Secondary|24h Trough FEV1|Trough FEV1 was defined as the mean of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. This was measured using central spirometry according to ATS/ERS standardization. This was analyzed using the same MIXED model as specified for the primary analysis.|Day 1, Week 26|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. day 1 or week 26.|||Liters||Standard Error|Least Squares Mean
2661872|NCT01566604|Secondary|Change From Baseline in Daily Rescue Medication Use (Number of Puffs)|The participant recorded the rescue medication taken in an electronic diary between visits and in the spirometry device during study visits. Daytime and nighttime rescue medication use (number of puffs) over 26 weeks was analyzed.|Baseline, 26 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study medication.|||Number of puffs||Standard Error|Least Squares Mean
2661873|NCT01566604|Secondary|Transition Dyspnea Index (TDI) Score|Dyspnea was measured at baseline using the Baseline Dyspnea Index (BDI) and during the treatment period using the TDI, which captures changes from baseline. The BDI and TDI each have three domains: functional impairment, magnitude of task and magnitude of effort, and each domain scored from -3 (major deterioration) to +3 (major improvement), giving an overall score of -9 to +9. A negative score indicates deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline.|Baseline, week 12, week 26|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 12 or week 26.|||score||Standard Error|Least Squares Mean
2661874|NCT01566604|Primary|Trough Forced Expiratory Volume in One Second (FEV1)|Baseline FEV1 was defined as the average of the -45 min and -15 min FEV1 values taken on day 1 prior to the first dose of study medication. Trough FEV1 was defined as the mean of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. FEV1 was measured using central spirometry according to ATS/ERS standardization. Trough FEV1 was analyzed using a MIXED model for the full analysis set population. The model contained treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation of short acting bronchodilator, FEV1 45 min post inhalation of short acting bronchodilator and baseline inhaled corticosteroids (ICS) use as covariates.|12 weeks|The number of participants considered for the analysis was from the full analysis set (randomized participants who received at least one dose of study medication). However, participants analyzed had both baseline and week 12 values.|||Liters||Standard Error|Least Squares Mean
2661875|NCT01566539|Other Pre-specified|Healthy Volunteers Groups: Mean Testosterone Plasma Level|Peripherals levels of testosterone will be assessed via assay of plasma collected.|Visit 1 (Up to 3 Hours)|Analysis was completed in the first batch of data collection from Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Due to the lack of funds, no subsequent analysis has been done on the samples collected.|||ng/dl||Standard Deviation|Mean
2661876|NCT01566539|Other Pre-specified|Healthy Volunteers Groups: Mean Oxytocin (OT) Plasma Level|Peripheral levels of OT will be assessed via assay of plasma collected.|Visit 1 (Up to 3 Hours)|Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with unreliable or missing data were excluded from the analysis.|||pg/ml||Standard Error|Mean
2661877|NCT01566539|Other Pre-specified|Healthy Volunteers Groups: Mean Vasopressin (AVP) Plasma Level|Peripheral levels of AVP will be assessed via assay of plasma collected.|Visit 1 (Up to 3 Hours)|Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with unreliable or missing data were excluded from the analysis.|||pg/ml||Standard Error|Mean
2661878|NCT01566539|Secondary|Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Men|The effect of the drug treatment will be assessed by determining differences in brain activation between OT and PL group when participants are viewing animations.|Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month)|Data was collected per protocol in the OT and placebo empathy task groups.|||percent signal change||Standard Deviation|Mean
2661879|NCT01566539|Secondary|Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Women|The effect of the drug treatment will be assessed by determining differences in brain activation between OT and PL group when participants are viewing animations.|Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month)|Data was collected per protocol in the OT and placebo empathy task groups.|||percent signal change||Standard Deviation|Mean
2661880|NCT01566539|Secondary|Faces Task Groups: Mean Attractiveness Rating of Faces in Women|Attractiveness is rated by a study specific seven point scale where -3 indicates least attractive and +3 indicates most attractive. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in attractiveness ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)|Data was collected per protocol in the AVP and placebo faces groups.|||units on a scale||Standard Deviation|Mean
2661881|NCT01566539|Secondary|Faces Task Groups: Mean Attractiveness Rating of Faces in Men|Attractiveness is rated by a study specific seven point scale where -3 indicates least attractive and +3 indicates most attractive. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in attractiveness ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)|Data was collected per protocol in the AVP and placebo faces groups.|||units on a scale||Standard Deviation|Mean
2661882|NCT01566539|Secondary|Faces Task Group: Mean Approachability Rating of Faces in Women|Approachability is rated by a study specific seven point scale where -3 indicates threatening and unapproachable and +3 indicates friendly and approachable. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in approachability ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)|Data was collected per protocol in the AVP and placebo faces groups.|||units on a scale||Standard Deviation|Mean
2661883|NCT01566539|Secondary|Faces Task Groups: Mean Approachability Rating of Faces in Men|Approachability is rated by a study specific seven point scale where -3 indicates threatening and unapproachable and +3 indicates friendly and approachable. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in approachability ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)|Data was collected per protocol in the AVP and placebo faces groups.|||units on a scale||Standard Deviation|Mean
2661884|NCT01566539|Secondary|Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Women|The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)|Analysis was completed for the Faces Task - Vasopressin (AVP) and Faces Task - Placebo groups per protocol. Subjects with missing data were excluded from the analysis.|||percent signal change||Standard Deviation|Mean
2661885|NCT01566539|Secondary|Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Men|The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)|Analysis was completed for the Faces Task - Vasopressin (AVP) and Faces Task - Placebo groups per protocol. Subjects with missing data were excluded from the analysis.|||percent signal change||Standard Deviation|Mean
2661886|NCT01566539|Secondary|Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Female During the Prisoners Dilemma Game|"The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered cooperative. The higher the total number, the more cooperative choices made."|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)|Analysis was completed for the Within Subject Group per protocol. Subjects with missing data were excluded from the analysis.|||number of choices||Standard Deviation|Mean
2661887|NCT01566539|Secondary|Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Male During the Prisoners Dilemma Game|"The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered cooperative. The higher the total number, the more cooperative choices made."|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)|Analysis was completed for the Within Subject Group per protocol. Subjects with missing data were excluded from the analysis. The difference between OT and PL visits is reported here (OT-PL).|||number of choices||Standard Deviation|Mean
2661888|NCT01566539|Secondary|Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Women During the Prisoners Dilemma Game|"The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered cooperative. The higher the total number, the more cooperative choices made."|Visit 1 (40-100 Minutes Post-Intervention)|Analysis was completed for the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with missing data were excluded from the analysis.|||number of choices||Standard Error|Mean
2661889|NCT01566539|Secondary|Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Men During the Prisoners Dilemma Game|"The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered cooperative. The higher the total number, the more cooperative choices made."|Visit 1 (40-100 Minutes Post-Intervention)|Analysis was completed for the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with missing data were excluded from the analysis.|||number of choices||Standard Error|Mean
2661890|NCT01566539|Primary|Within Subject Group: Mean Percent Signal Change in Left Caudate Nucleus in Men and Women|The effect of the drug will be assessed by determining changes in brain activation between the visit where the participant received drug and the visit where the participant received PL in the right caudate during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.|Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)|Analysis was completed for the within subject group per protocol. Subjects with excessive motion during scanning were excluded from the analysis.|||percent signal change||Standard Deviation|Mean
2661891|NCT01566539|Primary|Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Women|The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and placebo groups in the left insula during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.|Visit 1 (40-100 Minutes Post-Intervention)|Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis.|||percent signal change||Standard Error|Mean
2661892|NCT01566539|Primary|Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Men|The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and placebo groups in the left insula region during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.|Visit 1 (40-100 Minutes Post-Intervention)|Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis.|||percent signal change||Standard Error|Mean
2661893|NCT01566539|Primary|Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Women|The effect of the drug treatment will be assessed by determining differences in brain activation between OT and placebo groups in the right caudate nucleus region during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.|Visit 1 (40-100 Minutes Post-Intervention)|Analysis was completed in the Healthy Volunteers - Intranasal Oxytocin (OT) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis.|||percent signal change||Standard Error|Mean
2661894|NCT01566539|Primary|Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Men|The effect of the drug treatment will be assessed by determining differences in brain activation between OT and placebo groups in the right caudate nucleus region during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.|Visit 1 (40-100 Minutes Post-Intervention)|Analysis was completed in the Healthy Volunteers - Intranasal Oxytocin (OT) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis.|||percent signal change||Standard Error|Mean
2661895|NCT01566526|Secondary|Time to Improvement of 3 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement.|Baseline, Up to 12 Months|All enrolled patients with data for this data point who had an improvement of ≥ 3 lines in BCVA.|||Days||Full Range|Median
2661896|NCT01566526|Secondary|Time to Improvement of 2 Lines or More in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement.|Baseline, Up to 12 Months|All enrolled patients with data for this data point who had an improvement of ≥ 2 lines in BCVA.|||Days||Full Range|Median
2661897|NCT01566526|Secondary|Change From Baseline in Central Retinal Thickness in the Study Eye by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following Last Injection|OCT is measured in the study eye following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement. Data are reported for the 7-12 week period following the last injection.|Baseline, 7 to 12 weeks following the last injection|All enrolled patients with data for this data point.|||Micrometers (µm)||Standard Deviation|Mean
2661898|NCT01566526|Secondary|Percentage of Patients With an Increase of 3 Lines or More in BCVA From Baseline in the Study Eye|BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 3 lines or more indicates an improvement.|Baseline, Up to 12 Months|All enrolled patients with data for this data point.|||Percent of Participants|||Number
2661899|NCT01566526|Secondary|Percentage of Patients With an Increase of 2 Lines or More in BCVA From Baseline in the Study Eye|BCVA following the first injection of OZURDEX® is measured in the study eye using a special eye chart and is reported as the number of lines (5 letters per line) read correctly. An increase of 2 lines or more indicates an improvement.|Baseline, Up to 12 Months|All enrolled patients with data for this data point.|||Percent of Participants|||Number
2661900|NCT01566526|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following Last Injection in the Study Eye|BCVA is measured in the study eye following each injection of OZURDEX® using a special eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). A positive number improvement in the number of letters read means that the vision has improved. Data are reported for the 7-12 week period following the last injection.|Baseline, 7 to 12 weeks following the last injection|All enrolled patients with data for this data point.|||Letters||Standard Deviation|Mean
2661901|NCT01566526|Primary|Time to OZURDEX® Re-Injection in the Study Eye|The time interval is measured from the first OZURDEX® injection to the second OZURDEX® injection in the study eye.|Up to 12 Months|All enrolled patients.|||Days||Standard Deviation|Mean
2661902|NCT01566500|Secondary|Score of Psychosocial Predictors of Adherence|The Fisher IMB (Information-Seeking, Motivation and Behavior) adherence questionnaire will measure what psychosocial factors that act as predictive of medication adherence. The items pertaining to barriers to medication adherence were assessed the same day as enrollment and have a twelve month recall period.|Enrollment|||||||
2661903|NCT01566500|Secondary|Score on Barriers to Medication Adherence|The Chesney Adherence Questionnaire will be used to measure side effects, drug use and other barriers to medication adherence. The items pertaining to barriers to medication adherence were assessed the same day as enrollment and have a four-week recall period.|Enrollment|||||||
2661904|NCT01566500|Primary|Raw Count of Number of Days of Medication Nonadherence|"The primary outcome of this study is medication adherence as measured by self report with a 4 day recall adherence questionnaire (Chesney, Ickovics, Chambers, et al., 2000).~The total number of Nonadherence days were counted, then divided by the total number of days for all participants."|Enrollment|Adults with self-reported epilepsy.|||% of nonadherence days|||Number
2661905|NCT01566461|Secondary|Days of Hospitalization Due to the Index Lesion|Days of hospitalization from procedure through 12 month.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Days||Standard Deviation|Mean
2661906|NCT01566461|Secondary|Clinical Success|Clinical success is defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or Target vessel revascularization (TVR)) prior to discharge.|Day 1|Intention-to-Treat (n=331)|||Percentage of participants|||Number
2661907|NCT01566461|Secondary|Procedural Success|Procedural success is defined as residual stenosis of ≤50% (non-stented subjects) or ≤30% (stented subjects) by core lab assessment.|Day 1|Intention-to-Treat (n=331)|||Percentage of participants|||Number
2661908|NCT01566461|Secondary|Device Success|Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below rated burst pressure (RBP).|Day 1|Total number of devices used in the ITT population (n=331).|||Percentage of devices|Devices||Number
2661909|NCT01566461|Secondary|Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ)|"Walking capacity assessment by WIQ at 1 year compared to baseline. WIQ is a quality of life questionnaire that was specifically designed to assess the degree of impairment experienced by patients with claudication.~Clinical outcomes were assessed by patients responses to question 1A. Question 1A is specific for calf or buttocks claudication and is used to create a summary score for analysis. Question 1A is expressed on a scale of 0% (unable to perform because of severe claudication) to 100% (no impairment)."|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Units on a scale||Standard Deviation|Mean
2661910|NCT01566461|Secondary|Change in Walking Distance as Assessed by Six Minute Walk Test (6MWT)|Change from baseline in walking distance by Six Minute Walk Test (6MWT) at 12 month.|From baseline to 12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe. Data not collected in IN.PACT SFA I phase.|||Meters||Standard Deviation|Mean
2661911|NCT01566461|Secondary|Quality of Life Assessment by EuroQol Group 5-Dimension Self-Report Questionnaire (EQ5D)|"Quality of life assessment by EQ5D at 1 year compared to baseline. EQ5D is a standardised measure of health status and economic appraisal. The EQ5D consists of the EQ5D descriptive system which comprises the following variables for the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. A complex algorithm that took individual dimensions and generated an overall score was used.~EQ5D health state is used in the algorithm to calculate an overall score where - 0.109 = 'worst possible outcome' and 1.000 = 'best possible outcome'."|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Units on a scale||Standard Deviation|Mean
2661912|NCT01566461|Secondary|Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >3.4)||12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
2661922|NCT01566461|Secondary|Major Adverse Event (MAE) Composite|Major Adverse Event (MAE) composite is defined as all cause death, clinically-driven target vessel revascularization, major target limb amputation, thrombosis at the target lesion site.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
2661923|NCT01566461|Primary|Primary Safety Composite|Primary safety composite is defined as freedom from death through 30 days or target limb major amputation or clinically-driven target vessel revascularization (CD-TVR) within 12 months post index procedure.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of particpants|||Number
2661924|NCT01566461|Primary|Primary Patency|Primary patency is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤2.4.|12 month|Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.|||Percentage of participants|||Number
2661925|NCT01566435|Secondary|Progression-free Survival (PFS)|-Progression: at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|2 years||||percentage of participants|||Number
2661926|NCT01566435|Secondary|Disease-free Survival (DFS) Rate||2 years||||percentage of participants|||Number
2661927|NCT01566435|Secondary|Changes in Ki-67 Expression by Immunohistochemistry (IHC) in Primary Tumor Tissue|Ki-67 expression will be assessed at this institution by IHC stains performed on clinically available tumor specimens (paraffin blocks). The specimens will be collected retrospectively from prior biopsies (pre treatment and following 2 cycles of ACF) that will have consisted of a minimum of two needle cores (16-18 gauge) or two small incisional/excisional pieces of tumor. These will have been placed in 2% buffered formalin and transported to the surgical pathology processing lab.|6 weeks (2 cycles of therapy)||2023-10-31|10/2023||||
2661928|NCT01566435|Secondary|Complete Response (CR) or Partial Response (PR) at Regional (Neck) Nodes as Measured by Clinical Exam||6 weeks (2 cycles of therapy)|2 participants were not evaluable for this outcome measure.|||participants|||Number
2661929|NCT01566435|Secondary|Quality of Life (QOL)|"Assessed using questionnaires administered at 6 time points starting at baseline.~4 page questionnaire will assess physical, social, emotional, and functional well-being through questions designed specifically for patients with head and neck cancer.~An additional 4 question QOL survey will assess symptoms of peripheral neuropathy."|Through one year after completion of treatment||2023-10-31|10/2023||||
2661930|NCT01566435|Secondary|Changes in Secreted Protein Acidic and Rich in Cysteine (SPARC) Expression by Immunohistochemistry (IHC) in Primary Tumor Tissue|SPARC and Ki-67 expression will be assessed at this institution by IHC stains performed on clinically available tumor specimens (paraffin blocks). The specimens will be collected retrospectively from prior biopsies (pre treatment and following 2 cycles of ACF) that will have consisted of a minimum of two needle cores (16-18 gauge) or two small incisional/excisional pieces of tumor. These will have been placed in 2% buffered formalin and transported to the surgical pathology processing lab.|6 weeks (2 cycles of therapy)||2023-10-31|10/2023||||
2661931|NCT01566435|Secondary|Adverse Events as Measured by Number of Participants That Experienced Each Common Adverse Event During ACF Induction Therapy|Assessed by NCI-CTCAE version 3|From start of treatment through 30 days after end of treatment||||participants|||Number
2661932|NCT01566435|Secondary|Overall Survival Rate|-Overall survival rate is the percentage of participants who are alive at 2 years.|2 years||||percentage of participants|||Number
2661933|NCT01566435|Secondary|Metabolic Tumor Responses as Measured by FDG-PET/CT|"Complete metabolic response (CMR): Complete resolution of all metabolically active target and non-target lesions, and no interval development of new lesions~Partial metabolic response (PMR): 20% or greater decrease in max SUV from baseline, no metabolic progression of non-target lesions and no new lesions and/or decrease in total number of non-target lesions, no new lesions~Stable metabolic disease (SMD) - does not qualify for CMR, PMR, or PMD~Progressive metabolic disease (PMD): development of one or more metabolically active lesions or 20% or greater increased in max SUV from baseline, new metabolically active lesions"|6 weeks (2 cycles of therapy)|29 participants out of 30 participants were evaluable for this outcome measure.|||participants|||Number
2661934|NCT01566435|Secondary|Number of Participants Per Anatomic Tumor Response by CT Scan|"Response assessed using RECIST criteria version 1.0~Complete response: disappearance of all target lesions~Partial response: at least 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter~Non-complete response/non-progression: persistence of one or more non-target lesion and/or maintenance of tumor marker level above the upper limits of normal.~Progression: at least a 20% increase in the sum of the LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions."|6 weeks (2 cycles of therapy)||||participants|||Number
2661935|NCT01566435|Secondary|Percentage of Participants With Partial Response (PR) at Primary Tumor Site|"Response will be assessed by laryngoscopy.~PR: at least 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter"|6 weeks (2 cycles of therapy)||||percentage of participants|||Number
2661936|NCT01566435|Primary|Percentage of Participants With Complete Response (CR) by Clinical Exam at Primary Tumor Site|"Response will be assessed by laryngoscopy.~CR: disappearance of all lesions"|6 weeks (2 cycles of therapy)||||percentage of participants|||Number
2661937|NCT01566409|Secondary|Usage of Laxative||½ year|||||||
2661938|NCT01566409|Primary|Treatment Recovery|Recovery is defined as the child having no symptoms of constipation according to the Rome III criteria.|½ year||||participants|||Number
2661939|NCT01566370|Secondary|Change in Number of Drinks Per Week by Time|Comparison between medication and placebo groups on the change in number of drinks per week via interaction with time (from baseline to endpoint) using repeated measures|14 weeks (baseline to endpoint)|None of the subjects completed the study or made it to the 12 week endpoint.||||||
2661940|NCT01566370|Secondary|Change in Number of Heavy Drinking Days Per Week by Time|A comparison between medication and placebo on the measure of number heavy drinking days per week over the course of the study (baseline to endpoint) via interaction with time using repeated measures|14 weeks (baseline to endpoint)|None of the subjects completed the study or made it to the 12 week endpoint.||||||
2661941|NCT01566370|Secondary|Percentage of Total Drinking Days|The percentage of total drinking days compared between groups (zonisamide and placebo) during the time spent on the target dose of the medication (i.e., not including the titration or taper periods), which includes week 11, 12, 13, and 14.|4 weeks|None of the subjects completed the study or made it to the 12 week endpoint.||||||
2661942|NCT01566370|Secondary|Change in Beck Depression Inventory (BDI) Scores|Comparison between groups on change in BDI scores over the 14 weeks of the study, measured weekly, using repeated measures|14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.||||||
2661943|NCT01566370|Secondary|Change in Gamma Glutamyl Transferase (GGT)|Difference between groups on change in levels of GGT over time, measured at baseline, week 5, week 9, week 13, and endpoint, using repeated measures|14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.||||||
2661944|NCT01566370|Secondary|Change in Alcohol Urge Questionnaire Score|This is the change in AUQ scores (urge to drink) measured weekly compared between groups using repeated measures|from baseline to endpoint, 14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.||||||
2661945|NCT01566370|Secondary|Percentage of Abstinent Days|The difference in total percentage of abstinent compared between groups (zonisamide and placebo) during the time spent on the target dose of the medication (i.e., not including the titration or taper periods), which includes week 11, 12, 13, and 14.|over four weeks, from week 11 through 14|None of the subjects completed the study or made it to the 12 week endpoint.||||||
2661946|NCT01566370|Primary|Change in Clinician Assisted Rating Scale for Mania (CARS-M) Scores|Comparison between groups on change in scores on the CARS-M over 14 weeks from baseline to endpoint, measured weekly and analyzed with repeated measures|14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.||||||
2661947|NCT01566370|Primary|Change on Hamilton Depression Rating Scale|Change from baseline to endpoint in Hamilton scores compared between medication and placebo, using repeated measures|14 weeks|None of the subjects completed the study or made it to the 12 week endpoint.||||||
2661948|NCT01566370|Primary|Percentage of Total Heavy Drinking Days|The percentage of total heavy drinking days compared between groups (zonisamide and placebo) during the time spent on the target dose of the medication (i.e., not including the titration or taper periods), totaled between the time-points of weeks 11 and 14 (4 weeks time frame).|from week 11 through 14 (over 4 weeks)|None of the subjects completed the study or made it to the 12 week endpoint.||||||
2661949|NCT01566331|Primary|Partecipant With Perineal Laceration|The following types of lacerations were recorded during delivery: cervical laceration; mild perineal lacerations (defined as 1-2 lacerations); severe perineal lacerations (defined as 3-4 lacerations)|after delivery|intervention in normal pregnancies at term during labor and delivery|||participants|||Number
2661950|NCT01566214|Primary|Seattle Angina Questionnaire Disease Perception Scale|Disease Perception Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.|Change from baseline to 3-months post hospital discharge||||units on a scale||Standard Deviation|Mean
2661951|NCT01566214|Primary|Seattle Angina Questionnaire Treatment Satisfaction Scale|Treatment Satisfaction Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.|Change from baseline to 3-months post hospital discharge||||units on a scale||Standard Deviation|Mean
2661952|NCT01566214|Primary|Seattle Angina Questionnaire Angina Frequency Scale|Angina Frequency Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.|Change from baseline to 3-months post hospital discharge||||units on a scale||Standard Deviation|Mean
2661953|NCT01566214|Primary|Seattle Angina Questionnaire Angina Stability Scale|Angina Stability Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.|Change from baseline to 3-months post hospital discharge|Note that because 4 participants in the Usual Care group reported that they did not experience chest pain in the prior four weeks, their responses could not be included in the analysis, as the scale measures changes in the severity of chest pain. Therefore, only 2 participants in the Usual Care group contributed to the analysis.|||units on a scale||Standard Deviation|Mean
2661954|NCT01566214|Primary|Seattle Angina Questionnaire Physical Limitations Scale|Physical Limitations Subscale from the Seattle Angina Questionnaire. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.|Change from baseline to 3-months post hospital discharge||||units on a scale||Standard Deviation|Mean
2661955|NCT01566214|Primary|SF-36v General Health Scale|General Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.|Change from baseline to 3-months post hospital discharge||||units on a scale||Standard Deviation|Mean
2661956|NCT01566214|Primary|SF-36v Pain Scale|Pain Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.|Change from baseline to 3-months post hospital discharge||||units on a scale||Standard Deviation|Mean
2661957|NCT01566214|Primary|SF-36v Social Functioning Scale|Social Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.|Change from baseline to 3-months post hospital discharge||||units on a scale||Standard Deviation|Mean
2661958|NCT01566214|Primary|SF-36v Emotional Well-Being Scale|Emotional Well-Being Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.|Change from baseline to 3-months post hospital discharge||||units on a scale||Standard Deviation|Mean
2661959|NCT01566214|Primary|SF-36v Energy-Fatigue Scale|Energy-Fatigue Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.|Change from baseline to 3-months post hospital discharge||||units on a scale||Standard Deviation|Mean
2661960|NCT01566214|Primary|SF-36v Role Limitations Due to Emotional Problems Scale|Role Limitations Due to Emotional Problems Scale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.|Change from baseline to 3-months post hospital discharge||||units on a scale||Standard Deviation|Mean
2662490|NCT01562327|Secondary|Number of Participants Who Stopped Disease-Modifying Antirheumatic Drugs (DMARDs) Prior to Start of Tocilizumab||Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.|||participants|||Number
2661961|NCT01566214|Primary|SF-36v Role Limitations Due to Physical Health Scale|Role Limitations Due to Physical Health Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.|Change from baseline to 3-months post hospital discharge||||units on a scale||Standard Deviation|Mean
2661962|NCT01566214|Primary|SF-36v Physical Function Scale|Physical Functioning Subscale from the SF-36v. Possible scores range from 0 to 100, with higher scores indicating a better level of functioning.|Change from baseline to 3-months post hospital discharge|Participants who completed the SF-36v at baseline, 1 month, and 3 months.|||units on a scale||Standard Deviation|Mean
2661963|NCT01566162|Secondary|Intent to Attend Assessment|"The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = Not at all and 9 = Extremely. The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the baseline visit: How likely is it that you will complete the study?"|12 weeks|Only 1825 subjects answered the questionnaire.|||units on a scale||Standard Deviation|Mean
2661964|NCT01566162|Secondary|Smoking Questionnaire|Smoking questionnaire - average number of cigarettes per day at week 12 (LOCF).|12 weeks|Only 36 subjects who were smokers had the smoker questionnaire assessments.|||number of cigarettes smoked daily||Standard Deviation|Mean
2661965|NCT01566162|Secondary|Brief Adherence Rating Scale (BARS)|The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 100%) of doses taken by the subject in the previous month.|12 weeks||||percentage of monthly doses taken||Standard Deviation|Mean
2661966|NCT01566162|Secondary|Modified Specific Levels of Functioning (SLOF) Total Score.|The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items, each item is rated on a 5-point scale and mapped to 0 to 4. The total score will be the sum of all 24 items and ranges from 0 to 96. A higher score indicates worse condition.|12 weeks|Only 174 subjects had SLOF assessments at week 12 LOCF.|||units on a scale||Standard Deviation|Mean
2661967|NCT01566162|Secondary|Short Form-12 Health Survey (SF-12)|The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales. Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Baseline to week 12 LOCF endpoint|Only 182 subjects had post-baseline SF-12.v2 assessments.|||units on a scale||Standard Deviation|Mean
2661968|NCT01566162|Secondary|Change From Baseline in Montgomery -Asberg Depression Rating Scale Total Score|"The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity."|Baseline to week 12 LOCF endpoint|Only 182 subjects had post-baseline MADRS assessments.|||units on a scale||Standard Deviation|Mean
2661969|NCT01566162|Primary|Efficacy - Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Score.|The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.|Baseline to week 12 LOCF endpoint||||units on a scale||Standard Deviation|Mean
2661970|NCT01566162|Primary|Efficacy - Change in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|Baseline to week 12 LOCF endpoint||||units on a scale||Standard Deviation|Mean
2661971|NCT01566162|Primary|Safety - Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation, and Serious AEs (SAEs)|Number of subjects with treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation, and serious AEs (SAEs)|12 weeks||||participants|||Number
2661972|NCT01566149|Secondary|Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12|Baseline was defined as the highest FEV1 value of three assessments prior to first dose of study drug. If two (or all three) spirometry efforts had identical FEV1, the FEV1 from the effort with the highest Forced Vital Capacity (FVC) was to be recorded. Week 12 FEV1 was assessed as the morning FEV1 at the end of the dosing interval (trough FEV1). For participants who discontinued prior to Week 12, the FEV1 measurement from the discontinuation visit was to be be carried forward to Week 12 if (and only if) the participant's study medication compliance rate prior to discontinuation was at least 85%.|Baseline and Week 12|The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication and had at least one efficacy measurement post-dose.|||liters||Standard Deviation|Mean
2661973|NCT01566149|Primary|Number of Participants Who Discontinued From the Study Due to an AE|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to Week 12|The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.|||participants|||Number
2661974|NCT01566149|Primary|Number of Participants With At Least One Serious AE|"A serious AE was defined as any untoward medical occurrence or effect that at~any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; and/or cancer."|Up to Week 14|The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.|||participants|||Number
2662525|NCT01562132|Secondary|Number of Individuals With Treatment Related Serious Adverse Events||24 weeks|||||||
2661975|NCT01566149|Primary|Number of Participants With At Least One Drug-Related AE|A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.|Up to Week 14|The FAS population consisted of all participants assigned treatment who received at lease one dose of study medication.|||participants|||Number
2661976|NCT01566149|Primary|Number of Participants With At Least One Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to Week 14|The Full Analysis Set (FAS) population consisted of all participants assigned treatment who received at lease one dose of study medication.|||participants|||Number
2661977|NCT01566084|Secondary|BH4 Bioavailability|Change in FMD following acute oral tetrahydrobiopterin (BH4) is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability.|Immediately following acute administration of BH4 on Weeks 5 and 10|BH4 could not be administered to 3 participants due to canceled visits.|||percentage dilation||Standard Deviation|Mean
2661978|NCT01566084|Secondary|Vascular Oxidative Stress|Change in FMD following acute infusion of ascorbic acid (a dose known to scavenge superoxide) is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of vascular oxidative.|Immediately following acute infusion of ascorbic acid on Weeks 5 and 10|Ascorbic acid is missing in one participant due to a failed i.v.|||percentage dilation||Standard Deviation|Mean
2661979|NCT01566084|Primary|Improved Flow Mediated Dilation|FMD is analyzed at weeks 5 and 10 or after each condition in this cross-over study design. Subjects are randomly assigned to a low salt or normal salt condition for the first set of 5 weeks and then crossed over to the other condition for the second set of 5 weeks.|Week 5 (after first condition of low salt or normal salt), Week 10 (after second condition, opposite to first)|All subjects are analyzed under each condition because of the cross-over design.|||percentage dilation||Standard Deviation|Mean
2661980|NCT01565993|Secondary|Difficult to Place the Clip|The hemoclips which were incorrectly placed, mainly because the pedicles were very thick and/or short.|During endoscopic procedure was performed (between 2007 and 2010: period over which the study was conducted)|||||||
2661981|NCT01565993|Primary|The Number of Polyps With Complications After Polypectomy (The Total Complication Rate)|"In order to test the ability of prophylactic hemoclipping to prevent post-polypectomy bleeding, the investigators were required to register all the adverse events that occurred. These adverse events were called complications, despite their severity and clinical significance"|Between four and six weeks after the polypectomy, the patients were contacted by phone in order to confirm the absence of delayed bleeding|Based on an anticipated decrease of at least 12% in the rate of adverse bleeding events between the group A and the group B, there was an alpha error of 0.05 and a statistical power of 80% with a patient inclusion rate of 1:1. The number of polyps required is 146 per group. Using the Fleiss correction, the final number is 164 per group.|||polyps|Participants||Number
2661982|NCT01565980|Other Pre-specified|Baseline Values for All Measures.|Description of all measures are described elsewhere. Provided are the means and standard deviations for baseline comparisons.|Baseline.||||units on a scale||Standard Deviation|Mean
2661983|NCT01565980|Other Pre-specified|Pittsburgh Sleep Symptom Questionnaire-Insomnia (PSSQ_I)|The PSSQ_I has 13 self rated questions. The first 5 items, used to determine sleep quality (presence; frequency of insomnia problems) are rated [0 = never to 5 = always, 5-7 days per week; (range 0-25)] and items 6 to 13 are aimed at identifying the degree of interference experienced from sleep impairment (rated 0=not at all to 4=extremely on Likert scale; range 0 - 32).|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.||||units on a scale||Standard Error|Least Squares Mean
2661984|NCT01565980|Other Pre-specified|Worry (Cancer-related and General)|"Both cancer-related and general worry were measured with 3 item scales. Cancer-related worry had three statements asking about level of worry related to diagnosis, treatment, and worry interference using a 1 = not at all to 5 = most or all the time scale, range 3-15. Items are summed. General worry used an abbreviated brief Penn State Worry questionnaire with 3 statements that measure how typical that statements are in describing the person. Uses a 3 item scale with 1 = not at all typical to 5 = very typical. the range is 3-15. Items are summed."|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.||||units on a scale||Standard Error|Least Squares Mean
2661985|NCT01565980|Other Pre-specified|Cancer Dyspnea Scale|"The cancer dyspnea scale (CDS) has 12 Likert scale items ( 1 = Not at all, 5 = Very much) that ask questions about breathlessness or difficulty in breathing during the past few days. The CDS has an overall score (range 0-42) and 3 subscales that measure the amount of effort with breathing, anxiety associated with breathing, and discomfort associated with breathing.~The 3 subscales are calculated by: 1) effort (items 4+6+8+10+12) - 5 [range 0 (no dyspnea effort)-20 (worst dyspnea effort)]; 2) anxiety (items 5+7+9+11) - 4 [range 0 (no dyspnea anxiety) - 16 (worst dyspnea anxiety)]; 3) discomfort [15 - (items 1+2+3) {range 0 (no dyspnea discomfort) - 12 (worst dyspnea discomfort)}]. The total dyspnea score is derived by adding the total subscale scores. The subscale score subtractions are to make adjustments for 0 as a state of absence of dyspnea (thus total dyspnea summary scores range from 0 to 42)."|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.||||units on a scale||Standard Error|Least Squares Mean
2661986|NCT01565980|Other Pre-specified|Center for Epidemiologic Studies Depression (CES-D)|The score is the sum of the 20 questions. Each item has a range of 1 - 4 for frequency of a behavior or mental state in the past week ; 1 - Rarely or none of the time (less than 1 day); 2 = Some or a little of the time (1-2 days); 3 = Occasionally or a moderate amount of time (3-4 days); 4 = Most or all of the time (5-7 days). Possible range is 0-60. There are 4 reverse-scored items (questions 4, 8, 12, and 16). A score of 16 points or more is considered depressed.|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.||||units on a scale||Standard Error|Least Squares Mean
2661987|NCT01565980|Primary|SF-36|Health-related Quality of Life (HRQOL) Indices (Physical/Emotional Function, Role Function, Pain, General Health, Vitality, Mental/Physical Health)HRQOL(SF-36) calculated using Quality Metric, Inc. an algorithm producing normal scores (1-100 range). With normed scoring, general population has mean=50, SD=10. For the minimum and maximum values in each of the scale ranges provided, higher values represent a better outcome.|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.|Adjusted means of outcomes and standards error provided for T2 & 3, folllowed by summary of linear mixed effects models for the outcomes for group comparisons.|||units on a scale||Standard Error|Least Squares Mean
2661988|NCT01565980|Primary|M.D. Anderson Symptom Inventory (MDASI)|"Symptom Severity and interference were measured with the M.D. Anderson Symptom Inventory (MDASI) . The MDASI is a multisymptom patient-reported outcome measure. The MDASI has 13 core items include symptoms found to have the highest frequency and/or severity in patients with various cancers and treatment types (pain, fatigue, nausea, vomiting, disturbed sleep, distress, shortness of breath, memory difficulties, lack of appetite, drowsiness, dry mouth, sadness,numbness and tingling. Patients rate the severity of each symptom at its worst using 0-10 numerical rating scales with 0 = not present and 10 = as bad as you can imagine. The measure includes 5 symptom interference items which ask how much all symptoms, interfere with domains (walking, work, general activity, mood, relations with others, enjoyment of life) also rated on a 0-10 scale (0 = did not interfere; 10 = interfered completely). The 13 severity (range 0 - 130) and 5 interference items (range 0 - 50) are summed."|Time 2 (week 8), Time 3 (week 11), and overall average for group comparisons.|Adjusted means of outcomes and their standard errors are reported for times 2 and 3. The summary of linear mixed effects for group comparisons are then presented.|||units on a scale||Standard Error|Least Squares Mean
2661989|NCT01565941|Secondary|Insulin Algorithm Performance: Time-Weighted Glucose Average|Performance of the algorithm across diverse ages, weights and disease processes will be critical to measure and compare to other published algorithm performance. We will track the overall glycemic profile using time-weighted glucose average because it is uniquely unaffected by the increased frequency of BG determinations that occur when glucose is abnormally low or high.|Until study discharge, up to 28 days following randomization||||mg/dL||Inter-Quartile Range|Median
2661990|NCT01565941|Secondary|Insulin Algorithm Performance: Time in the Target Range|Performance of the algorithm across diverse ages, weights and disease processes will be critical to measure and compare to other published algorithm performance. Ideally, the algorithm will maximize time spent in the glucose target range. We will track the overall glycemic profile using time-weighted glucose average because it is uniquely unaffected by the increased frequency of BG determinations that occur when glucose is abnormally low or high.|Until study discharge, up to 28 days following randomization||||Percentage of time||Inter-Quartile Range|Median
2661991|NCT01565941|Secondary|Insulin Algorithm Performance: Time to the Target Range|Performance of the algorithm across diverse ages, weights and disease processes will be critical to measure and compare to other published algorithm performance. Ideally, the algorithm will minimize time to glucose target range. We will track the overall glycemic profile using time-weighted glucose average because it is uniquely unaffected by the increased frequency of BG determinations that occur when glucose is abnormally low or high.|Until study discharge, up to 28 days following randomization||||Hours||Inter-Quartile Range|Median
2661992|NCT01565941|Secondary|Nursing Workload|The cognitive burden placed upon bedside nurses when managing a patient on TGC will be described. Bedside nurses will be randomly selected to complete an anonymous survey describing their perceptions of workload burden associated with managing a patient on TGC. Nurses' perceptions of their capacity to complete both TGC‐related and non TGC-related nursing activities over several intervals of the study period will be described via qualitative and summary statistics.|Multiple intervals during the study period|||||||
2661993|NCT01565941|Secondary|Participants With Hypokalemia (<2.5 mmol/L)|Hypoglycemia will be tracked and reported according to three ranges: severe (<40 mg/dL), moderate (40-49 mg/dL) and mild (50-59 mg/dL). As insulin infusion can cause slight changes to serum potassium concentration, hypokalemia <2.5 mmol/L will also be tracked.|Participants will be followed for the duration of ICU stay, an expected average of 8 days||||Participants|||Count of Participants
2661994|NCT01565941|Secondary|Participants With Any Hypoglycemia (<60 mg/dL), Related to Insulin Infusion (Insulin Algorithm Safety)|Hypoglycemia will be tracked and reported according to three ranges: severe (<40 mg/dL), moderate (40-49 mg/dL) and mild (50-59 mg/dL). As insulin infusion can cause slight changes to serum potassium concentration, hypokalemia <2.5 mmol/L will also be tracked.|Participants will be followed for the duration of ICU stay, an expected average of 8 days||||Participants|||Count of Participants
2661995|NCT01565941|Secondary|Participants With Any Hypoglycemia (<60 mg/dL), Unrelated to Insulin Infusion (Insulin Algorithm Safety)|Hypoglycemia will be tracked and reported according to three ranges: severe (<40 mg/dL), moderate (40-49 mg/dL) and mild (50-59 mg/dL). As insulin infusion can cause slight changes to serum potassium concentration, hypokalemia <2.5 mmol/L will also be tracked.|Participants will be followed for the duration of ICU stay, an expected average of 8 days||||Participants|||Count of Participants
2661996|NCT01565941|Secondary|Participants With Severe Hypoglycemia (<40 mg/dL), Related to Insulin Infusion (Insulin Algorithm Safety)|Hypoglycemia will be tracked and reported according to three ranges: severe (<40 mg/dL), moderate (40-49 mg/dL) and mild (50-59 mg/dL). As insulin infusion can cause slight changes to serum potassium concentration, hypokalemia <2.5 mmol/L will also be tracked.|Participants will be followed for the duration of ICU stay, an expected average of 8 days||||Participants|||Count of Participants
2661997|NCT01565941|Secondary|Participants With Severe Hypoglycemia (<40 mg/dL), Unrelated to Insulin Infusion (Insulin Algorithm Safety)|Hypoglycemia will be tracked and reported according to three ranges: severe (<40 mg/dL), moderate (40-49 mg/dL) and mild (50-59 mg/dL). As insulin infusion can cause slight changes to serum potassium concentration, hypokalemia <2.5 mmol/L will also be tracked.|Participants will be followed for the duration of ICU stay, an expected average of 8 days||||Participants|||Count of Participants
2661998|NCT01565941|Secondary|Incidence of Wound Infection Incidence of Wound Infection|We will use Centers for Disease Control's (CDC) most recently published definition for the following nosocomial infection attributable to the ICU stay: wound infections that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. This non-device-related infection will be counted per 1,000 ICU days.|Up to 48 hours after ICU discharge||||Infections/1000 ICU days|||Number
2661999|NCT01565941|Secondary|Incidence of Ventilator-Associated Pneumonia|We will use Centers for Disease Control's (CDC) most recently published definition for the following nosocomial infection attributable to the ICU stay: respiratory tract infections including ventilator-associated pneumonias that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. This device-related infection will be counted per 1,000 device days.|Up to 48 hours after ICU discharge||||Infections/1000 ventilator days|||Number
2662526|NCT01562132|Secondary|Number of Individuals With Treatment Related Adverse Events||24 weeks|||||||
2662527|NCT01562132|Secondary|Proportion of Individuals Requiring Dose Reduction||24 weeks|||||||
2662000|NCT01565941|Secondary|Incidence of Catheter-Associated Urinary Tract Infection|We will use Centers for Disease Control's (CDC) most recently published definition for the following nosocomial infection attributable to the ICU stay: urinary tract infections that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. This device-related infection will be counted per 1,000 device days.|Up to 48 hours after ICU discharge||||Infections/1000 bladder catheter days|||Number
2662001|NCT01565941|Secondary|Incidence of Catheter-Associated Bloodstream Infection|We will use Centers for Disease Control's (CDC) most recently published definition for the following nosocomial infection attributable to the ICU stay: Central Venous Line (CVL)-associated bloodstream infections (BSI) that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit. This device-related infection will be counted per 1,000 device days.|Up to 48 hours after ICU discharge||||Infections/1000 CVC days|||Number
2662002|NCT01565941|Secondary|Participants With Device-Related or Non-Device Related Nosocomial Infection|We will use Centers for Disease Control's (CDC) most recently published definitions for the following nosocomial infections attributable to the ICU stay: total bloodstream infections including Central Venous Line (CVL)-associated bloodstream infections (BSI), respiratory tract infections including ventilator-associated pneumonias, urinary tract infections, and wound infections that occur in the ICU or within 48 hours of discharge to the non-ICU inpatient unit.|Up to 48 hours after ICU discharge||||Participants|||Count of Participants
2662003|NCT01565941|Secondary|Developmental Neurobehavioral Outcomes: VABS-II Composite|Reliable, reproducible measures of adaptive functioning, behavior and quality of life will be used to determine outcomes at baseline (CBCL, PedsQL) and at one year after ICU discharge (Vineland-II, CBCL, PedsQL). The goal of baseline data collection is to assess pre-ICU health and quality of life. The results of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II) are reported. Scores range from 20-160, with higher scores being better.|One year after ICU course||||Score on a scale||Standard Deviation|Mean
2662004|NCT01565941|Secondary|Ventilator-Free Days|Ventilator-free days during the 28 days following randomization encompasses both reduction in the duration of ventilation and improvement in mortality. The end of the subject's duration of ventilation is defined as the date/time of extubation for subjects who are intubated, or the date/time of the discontinuation of mechanical ventilation for subjects with tracheostomy.|28 days following randomization||||Days||Inter-Quartile Range|Median
2662005|NCT01565941|Secondary|Accumulation of Multiple Organ Dysfunction Syndrome (MODS)|Accumulation of MODS during the 28 days following randomization will be measured. MODS is defined as the concurrent dysfunction of two or more organ systems (e.g., acute lung injury and renal failure). The clinical relevance of MODS as a surrogate outcome measure is well recognized in the intensive care community, and there is a clear relationship between the number of dysfunctional organ systems and the risk of death in critically ill children.|28 days after randomization||||Participants|||Count of Participants
2662006|NCT01565941|Secondary|28-day Hospital Mortality|We will collect data on 28-day hospital mortality.|28 days after randomization||||Participants|||Count of Participants
2662007|NCT01565941|Secondary|90-day Hospital Mortality|In order to enable direct comparisons between data gathered in HALF-PINT and the prior adult NICE-SUGAR trial, we will collect data on 90-day hospital mortality.|90 days after randomization||||Participants|||Count of Participants
2662008|NCT01565941|Primary|ICU-Free Days|28-day hospital mortality-adjusted ICU length of stay.|Study day 28||||Days||Inter-Quartile Range|Median
2662009|NCT01565928|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of Docetaxel With and Without Enzalutamide Treatment|AUCinf was observed using a linear mixed-effects model.|Docetaxel without Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 1; Docetaxel with Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 2|PK population included all enrolled participants who received at least 2 doses of Docetaxel (75 mg/m^2) and underwent PK sampling after both doses. Here, 'Number analyzed' signifies number of participants who were evaluable for the specified category.|||nanograms*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2662010|NCT01565928|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUClast) of Docetaxel With and Without Enzalutamide Treatment|AUClast was observed using a linear mixed-effects model.|Docetaxel without Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 1; Docetaxel with Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 2|PK population included all enrolled participants who received at least 2 doses of Docetaxel (75 mg/m^2) and underwent PK sampling after both doses. Here, 'Number analyzed' signifies number of participants who were evaluable for the specified category.|||nanograms*hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2662011|NCT01565928|Secondary|Maximum Plasma Concentration (Cmax) of Docetaxel With and Without Enzalutamide Treatment||Docetaxel without Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 1; Docetaxel with Enzalutamide: Predose, 0.5, 1, 1.5, 2, 4, 8 and 24 hour post docetaxel infusion on Day 1 of Treatment Period 2|Pharmacokinetic (PK) population included all enrolled participants who received at least 2 doses of Docetaxel (75 mg/m^2) and underwent PK sampling after both doses. Here, 'Number analyzed' signifies number of participants who were evaluable for the specified category.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2662012|NCT01565928|Secondary|Number of Participants With Clinically Significant Change From Baseline in Electrocardiograms (ECG)|"Clinically significant changes from baseline in ECG findings was based up on investigator's discretion. T1 = Timeframe for Combination Therapy: Docetaxel 75 mg/m^2+ Enzalutamide 160 mg and T2 = Time frame for Post-Docetaxel Enzalutamide 160 mg."|T1= Baseline (Day 1) up to a maximum of approximately Month 12; T2 = From Month 10.6 up to a maximum of approximately Month 71.5|Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).|||Participants|||Count of Participants
2662172|NCT01564732|Secondary|Quantitative Change in Diabetes|Blood Sugar will be measured over the scheduled visits and the change in preoperative and postoperative glucose levels will be determined. We will also assess the need for medications to treat diabetes before and after surgery.|36 months|Data not collected||||||
2662528|NCT01562132|Secondary|Proportion of Individuals Requiring Treatment Discontinuation||4 weeks|||||||
2662013|NCT01565928|Secondary|Number of Participants With Clinically Significant Abnormalities in Vital Signs|"Criteria:1)systolic blood pressure (SBP):a) absolute result(AR)>=180millimeters of mercury(mmHg) and increase from baseline(BL)greater than(>)40mmHg,b)less than(<)90mmHg and decrease from BL>30mmHg,c)most extreme post-BL result>=140mmHg,d)most extreme post-BL result>=180mmHg,e)most extreme result(MER)>=180mmHg and >=20mmHg change from BL,f)MER>=140mmHg and >=20mmHg change from BL;2)diastolic blood pressure(DBP):a)AR>105mmHg and increase from BL,b)AR<50mmHg and decrease from BL>20mmHg;c)most extreme post-BL result>=90mmHg,d)MER>=90mmHg and >=15mmHg change from BL,e)most extreme post-BL result>=105mmHg,f)MER>=105mmHg and>=15mmHg change from BL;3)heart rate:a)AR>120 beats per minute(bpm) and increase from BL>30bpm,b) AR<50 bpm and decrease from BL>20bpm.Only those categories in which at least 1 participant had clinically significant vital sign abnormality, were reported in this outcome measure.T1 = Timeframe for Combination Therapy and T2 = Time frame for Post-Docetaxel Enzalutamide."|T1= Baseline (Day 1) up to a maximum of approximately Month 12; T2 = From Month 10.6 up to a maximum of approximately Month 71.5|Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).|||Participants|||Count of Participants
2662014|NCT01565928|Primary|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)|AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Percentage of participants that discontinued study drug due to adverse events were reported in this outcome measure.|Treatment Period 1 (Day 1) up to end of study treatment (maximum 70 months)|Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).|||percentage of participants|||Number
2662015|NCT01565928|Primary|Percentage of Participants Who Required Study Drug Dose Reduction During Treatment Periods 1 and 2|Percentage of participants that required dose reductions of Docetaxel and Enzalutamide treatment were reported in this outcome measure. Dose modifications (interruptions or dose reductions) were permitted for participants who had adverse events that were intolerable or could not be improved by other means. Dose reductions or delays were determined according to the prescribing information and at the discretion of the investigator.|Treatment Period 1 (Day 1) up to end of Treatment Period 2 (42 days)|Safety population included all enrolled participants who received at least 1 dose or partial dose of study drug (Enzalutamide and/or Docetaxel).|||percentage of participants|||Number
2662016|NCT01565902|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death Adverse Events (Frequency of Adverse Events, Serious Adverse Events, and Notable Laboratory Abnormalities) of of BAF312 After a Single Dose of BAF312|Physical examination, vital signs, body temperature, standard safety laboratory evaluations (hematology, clinical chemistry, coagulation, Hepatitis B and C and HIV serology, α-fetoprotein [in hepatically impaired subjects only], pregnancy test, alcohol and drug screen), standard 12-lead electrocardiogram , cardiac monitoring, 24-h Holter ECG, suicidality assessment (C-SSRS), (serious) adverse event monitoring.|Day -1 to 22|The safety analysis set consists of all subjects that received study drug and with no protocol deviations with relevant impact on safety.|||Participants|||Number
2662017|NCT01565902|Primary|Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax)|The pharmacokinetics of BAF312 were studied in plasma up to 504 hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose|pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose|The PK analysis set consists of all completed subjects with quantifiable pharmacokinetic (PK) measurements. To reduce the number of healthy subjects exposed to BAF312, study allowed matching of subjects with hepatic impairment to healthy subjects. A healthy subject served as matching partner for up to 3 subjects with hepatic impairment|||(ng/mL)||Standard Deviation|Mean
2662018|NCT01565902|Primary|Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)|The pharmacokinetics of BAF312 were studied in plasma up to 504 hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.|pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.|The PK analysis set consists of all completed subjects with quantifiable pharmacokinetic (PK) measurements. To reduce the number of healthy subjects exposed to BAF312, study allowed matching of subjects with hepatic impairment to healthy subjects. A healthy subject served as matching partner for up to 3 subjects with hepatic impairment|||h*ng/mL||Standard Deviation|Mean
2662019|NCT01565902|Primary|Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)|The pharmacokinetics of BAF312 were studied in plasma up to 504 hours post-dose at the following time points: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.|pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 144, 216, 312, 408 and 504 hours post dose.|The PK analysis set consists of all completed subjects with quantifiable pharmacokinetic (PK) measurements. To reduce the number of healthy subjects exposed to BAF312, study allowed matching of subjects with hepatic impairment to healthy subjects. A healthy subject served as matching partner for up to 3 subjects with hepatic impairment|||h*ng/mL||Standard Deviation|Mean
2662020|NCT01565889|Primary|Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)|The percentage of participants discontinuing any study drug due to an adverse event was summarized.|Up to 12 weeks|Safety Analysis Set: participants who received at least 1 dose of study drug(s)|||percentage of participants|||Number
2662021|NCT01565889|Other Pre-specified|Part B: On-treatment HIV RNA|Data for this outcome measure were collected for participants in Part B only.|Up to 8 weeks|Part B Safety Analysis Set: participants enrolled in Part B and received at least one dose of study drug(s).|||copies/mL||Standard Deviation|Mean
2662022|NCT01565889|Other Pre-specified|Part B: On-treatment HCV RNA|Data for this outcome measure were collected for participants in Part B only.|Up to 8 weeks|Part B Full Analysis Set|||log10 IU/mL||Standard Deviation|Mean
2662529|NCT01562132|Secondary|Achieve Targeted Recruitment, Retention and Adherence Rates||24 weeks|||||||
2662676|NCT01560260|Secondary|Overall Survival (OS)|Analyzed using Kaplan-Meier curves for the all treated and per protocol populations.|Estimates at 9 months||||percentage of participants|||Number
2662023|NCT01565889|Secondary|Part B: Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse|"Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA > LLOQ) on treatment after having previously had undetectable HCV RNA levels (HCV RNA < LLOQ) while on treatment.~Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.~Data for this outcome measure were collected for participants in Part B only."|Posttreatment Weeks 4 and 24|Part B Full Analysis Set|||percentage of participants|||Number
2662024|NCT01565889|Secondary|Part B: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)|"SVR4 and SVR24 was defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.~Data for this outcome measure were collected for participants in Part B only."|Posttreatment Weeks 4 and 24|Part B Full Analysis Set|||percentage of participants|||Number
2662025|NCT01565889|Primary|Part B: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)|"SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.~Data for this outcome measure were collected for participants in Part B only."|Posttreatment Week 12|Part B Full Analysis Set: participants enrolled into Part B of the study and dosed with at least 1 dose of study drug(s)|||percentage of participants|||Number
2662026|NCT01565889|Primary|Part A: Plasma Pharmacokinetics of SOF, EFV, TFV, and FTC: Cmax at Day 7|"Cmax: maximum observed concentration of drug in plasma.~Data for this outcome measure were collected for participants in Part A only."|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose|Participants in the PK Analysis Set with available data were included.|||ng/mL||Standard Deviation|Mean
2662027|NCT01565889|Primary|Part A: Plasma Pharmacokinetics of SOF, EFV, Tenofovir (TFV), and FTC: AUCtau at Day 7|"AUCtau: concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).~Data for this outcome measure were collected for participants in Part A only."|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours postdose|"Pharmacokinetics (PK) Analysis Set: participants with evaluable PK profiles who enrolled into Part A of the study and received study drug.~Participants in the PK Analysis Set with available data were included."|||h*ng/mL||Standard Deviation|Mean
2662028|NCT01565850|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with Week 48 data were analyzed.|||cells/µL||Standard Deviation|Mean
2662029|NCT01565850|Secondary|Change From Baseline in CD4+ Cell Count at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with Week 24 data were analyzed.|||cells/µL||Standard Deviation|Mean
2662030|NCT01565850|Secondary|Change From Baseline in HIV-1 RNA at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with Week 48 data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2662031|NCT01565850|Secondary|Change From Baseline in HIV-1 RNA at Week 24||Baseline; Week 24|Participants in the Full Analysis Set with Week 24 data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2662032|NCT01565850|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The snapshot algorithm was used which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set|||percentage of participants|||Number
2662033|NCT01565850|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24|The snapshot algorithm was used which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: participant who were randomized;enrolled and received at least one dose of study drug|||percentage of participants|||Number
2662034|NCT01565707|Secondary|Change From Baseline in Post Void Residual (PVR) Volume|Post Void Residual (PVR) Volume was assessed by ultrasonography or bladder scan.|Baseline and Week 12|The study analysis population for this endpoint consisted of the SAF.|||mL||Standard Deviation|Least Squares Mean
2662035|NCT01565707|Secondary|Number of Participants With Adverse Events (AEs)|A treatment emergent adverse event (TEAE) was defined as an AE that occurred after the first dose of study drug and within 7 days after last dose of study medication.|From the first dose of study drug until 7 days after last dose of study medication (13 weeks).|The study analysis for this endpoint consisted of the Safety Analysis Set (SAF), the SAF consisted of all patients who received at least 1 dose of double-blind study medication and for whom any safety data were reported after first dose of study drug.|||participants|||Number
2662036|NCT01565707|Secondary|Apparent Volume of Distribution (Vz/F) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.|||L||Standard Deviation|Mean
2662037|NCT01565707|Secondary|Apparent Total Body Clearance (CL/F) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.|||L/h||Standard Deviation|Mean
2662038|NCT01565707|Secondary|Apparent Terminal Elimination Half-Life (T1/2) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.|||hours||Standard Deviation|Mean
2662039|NCT01565707|Secondary|Area Under the Plasma Concentration - Time to Curve (AUC) for a Dose Interval (AUCtau) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.|||ng*h/mL||Standard Deviation|Mean
2662173|NCT01564732|Secondary|Quantitative Change in Hypertension|Systolic and Diastolic Blood Pressure will be measured over the scheduled visits and the change in preoperative and postoperative blood pressure will be determined. We will also assess the need for medications to treat hypertension before and after surgery.|36 months|Data not collected.||||||
2662040|NCT01565707|Secondary|Plasma Concentration Before Drug Administration (Ctrough) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment. Ctrough could not be calculated for 2 children and 1 adolescent in the PKAS.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.|||ng/mL||Standard Deviation|Mean
2662041|NCT01565707|Secondary|Time to Attain Maximum Concentration (Tmax) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment. Tmax could not be calculated for 2 children and 1 adolescent in the PKAS.|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS.|||hours||Standard Deviation|Mean
2662042|NCT01565707|Secondary|Maximum Concentration (Cmax) of Solifenacin|Pharmacokinetic sampling was performed at steady state at the end of treatment. Cmax could not be calculated for 2 children and 1 adolescent in the Pharmacokinetic Analysis Set (PKAS).|Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).|The study analysis population for this endpoint consisted of the PKAS. The PKAS consisted of the subset of the Safety Analysis Set (SAF) for which plasma concentration data were available to facilitate derivation of at least 1 pharmacokinetic parameter and for whom the time of last dose prior to sampling was known.|||ng/mL||Standard Deviation|Mean
2662043|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents|Adolescent participants were asked to record the degree of urgency associated with each micturition and incontinence episode according to the Patient Perception of Intensity of Urgency Scale (PPIUS) scale (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). The mean number of grade 3 or 4 urgency episodes was determined using using diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS including participants for whom data were available (adolescents only). Missing values at EoT were imputed using the last observation carried forward (LOCF) method.|||urgency episodes||Standard Error|Least Squares Mean
2662044|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Nighttime Micturitions Per 24 Hours|The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Nighttime is defined as the time between going to bed and waking up the following morning.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.|||nighttime micturitions||Standard Error|Least Squares Mean
2662045|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Daytime Micturitions Per 24 Hours|The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Daytime is defined as the time between waking up in the morning and going to bed later the same day.|Baseline and week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.|||daytime micturitions||Standard Error|Least Squares Mean
2662046|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours|The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.|||micturitions||Standard Error|Least Squares Mean
2662047|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Nighttimes Per 7 Days|The mean number of dry nights was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.|||Dry Nights||Standard Error|Least Squares Mean
2662048|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Days Per 7 Days|The mean number of dry days was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.|||Dry Days||Standard Error|Least Squares Mean
2662049|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Nighttime Incontinence Episodes Per 24 Hours|The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Nighttime is defined as the time between going to bed and waking up the following morning.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.|||nighttime incontinence episodes||Standard Error|Least Squares Mean
2662050|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Daytime Incontinence Episodes Per 24 Hours|The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Daytime is defined as the time between waking up in the morning and going to bed later the same day.|Baseline and Week 12|Full analysis set including patients for whom data were available. Missing values at EoT were imputed using the last observation carried forward (LOCF) method.|||daytime incontinence episodes||Standard Error|Least Squares Mean
2662174|NCT01564732|Secondary|Quality of Life||36 months|data not collected||||||
2662175|NCT01564732|Primary|Weight Loss||36 months|Data not collected.||||||
2662051|NCT01565707|Secondary|Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.|||incontinence episodes||Standard Error|Least Squares Mean
2662052|NCT01565707|Secondary|Change From Baseline to End of Treatment in Daytime Maximum Volume Voided (DMaxVV) Per Micturition|The mean daytime maximum volume voided (DMaxVV) was determined using the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the Baseline and end of treatment visits. The daytime maximum volume voided (DMaxVV) is the largest (non-zero) volume recorded over both of the 2 measuring days in the diary. The first morning void is excluded from the calculation. Daytime is defined as the time between waking up in the morning and going to bed later the same day. A micturition is any voluntary urination, excluding episodes of incontinence.|Baseline and Week 12|The study analysis population for this endpoint consisted of the FAS population. Missing values at EoT were imputed using the LOCF method.|||mL||Standard Error|Least Squares Mean
2662053|NCT01565707|Primary|Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition|The mean voided volume was calculated from the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the baseline and end of treatment visits. The MVV is equal to the mean of the non-zero volumes recorded over the 2 measuring days. A micturition is any voluntary urination, excluding episodes of incontinence.|Baseline and Week 12|Full Analysis Set (FAS) consists of all randomized patients that took at least one dose of double-blind study medication after randomization and provided both valid baseline and post-baseline values for the primary efficacy endpoint. Missing values at EoT were imputed using the last observation carried forward (LOCF) method.|||mL||Standard Error|Least Squares Mean
2662054|NCT01565694|Secondary|Number of Participants With Adverse Events|A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the first dose of study medication on Day 1. All adverse events collected within 7 days after taking the last dose of study drug were counted as a TEAE.|Baseline to End of Study Visit (Week 52)|The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug.|||Participants|||Count of Participants
2662055|NCT01565694|Secondary|Change From Baseline in Quality of Life [QoL] (PinQ Questionnaire Score)|Pediatric Incontinence Questionnaire (PinQ) is a 20-item questionnaire addressing quality of life for participants with bladder disorders. Each question was answered on a scale from 0 (no, never) to 4 (all the time). The total score ranged from 0 to 80, with higher scores indicated more impact on the quality of life.|Baseline to Week 24|The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.|||Units on a Scale||Standard Deviation|Mean
2662056|NCT01565694|Secondary|Change From Baseline in Number of Dry (Incontinence-Free) Nights Per 7 Days|The number of incontinence-free nights was calculated from the 7-day micturition diary.|Baseline to Week 24|The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.|||Nights||Standard Deviation|Mean
2662057|NCT01565694|Secondary|Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days|The number of incontinence-free days was calculated from the 7-day micturition diary.|Baseline to Week 24|The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.|||Days||Standard Deviation|Mean
2662058|NCT01565694|Secondary|Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours|The mean of the number of incontinence episodes per 24h was calculated as the mean over the valid diary days in the 7-day diary.|Baseline to Week 24|The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.|||Incontinence Episodes||Standard Deviation|Mean
2662059|NCT01565694|Secondary|Change From Baseline in Average First Morning Catheterized Volume|The average first morning catheterized volume was calculated as the average of the available first morning catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days are concurrent.|Baseline to Week 24|The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.|||mL||Standard Deviation|Mean
2662060|NCT01565694|Secondary|Change From Baseline in Maximum Catheterized Volume|The maximum catheterized volume per day was calculated using all available (non-zero) catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days were concurrent. The maximum value was calculated separately for each measuring day and the mean of these two values was used.|Baseline to Week 24|The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.|||mL||Standard Deviation|Mean
2662061|NCT01565694|Secondary|Change From Baseline in Average Catheterized Volume Per Catheterization|The average catheterized volume per catheterization was calculated using all available (non-zero) catheterized volumes recorded over both of the 2 measuring days in the diary, whether or not these 2 days are concurrent.|Baseline to Week 24|The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.|||mL||Standard Deviation|Mean
2662677|NCT01560260|Secondary|Clinical Benefit Rate Defined as Stable Disease (SD) >= 9 Months, Partial Response (PR) or Complete Response (CR)|Prolonged non-progression is of clinical benefit (CR + PR + SD at 9 months).|Up to 2 years||||percentage of participants|||Number
2662062|NCT01565694|Secondary|Change From Baseline in Detrusor Pressure at the End of Bladder Filling|The bladder was filled until voiding/leakage began or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. Pressure was recorded for an extra 5 minutes after leakage began or the end of bladder-filling, whichever is sooner.|Baseline to Week 24|The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.|||cmH2O||Standard Deviation|Mean
2662063|NCT01565694|Secondary|Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until End of Bladder Filling|"Change from baseline in number of overactive detrusor contractions until end of bladder filling was measured by urodynamic testing. If leakage occurred, the Detrusor pressure at leakage was recorded otherwise the volume of fluid instilled into the bladder was recorded."|Baseline to Week 24|The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.|||Detrusor Contractions||Standard Deviation|Mean
2662064|NCT01565694|Secondary|Change From Baseline in Bladder Volume at 40 cmH2O Detrusor Pressure|Bladder volumes at 40 cm H2O detrusor pressure were calculated using urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached.|Baseline and Week 24|The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized. Only participants who reached 40 cmH20 detrusor pressure were included in the analysis.|||mL||Standard Deviation|Mean
2662065|NCT01565694|Secondary|Change From Baseline in Bladder Volume at 30 cmH2O Detrusor Pressure|Bladder volumes at 30 cm H2O detrusor pressure was calculated using the urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the participants experiences pain or discomfort or 135% of expected bladder capacity for age has been reached.|Baseline and Week 24|The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized. Only participants who reached 30 cmH20 detrusor pressure were included in the analysis.|||mL||Standard Deviation|Mean
2662066|NCT01565694|Secondary|Change From Baseline in Bladder Volume (mL) Until First Detrusor Contraction > 15 cmH2O as a Percentage of Expected Bladder Capacity (EBC)|Change from baseline in the bladder volume was calculated using urodyanamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. If no detrusor contraction of at least 15 cmH2O occurs, the bladder volume was imputed with MCC.|Baseline and Week 24|The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug.|||Percentage of EBC||Full Range|Median
2662067|NCT01565694|Secondary|Change From Baseline in Bladder Compliance|Bladder compliance gives an indication of the elasticity of the bladder wall and was calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder.|Baseline and Week 24|The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.|||mL/cmH2O||Standard Deviation|Mean
2662068|NCT01565694|Secondary|Change From Baseline to Last Possible Titration Step in Maximum Cystometric Capacity|During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed. Based on study requirements, the last possible titration step was Week 9 for participants enrolled under versions 1.0 and 1.1 and Week 12 under later versions.|Baseline, Week 9 or Week 12|The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. The number of participant analyzed represents participants with a non-missing change from baseline to last possible titration step.|||mL||Standard Deviation|Mean
2662069|NCT01565694|Primary|Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)|During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed.|Baseline and Week 24|The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.|||mL||Standard Deviation|Mean
2662070|NCT01565668|Secondary|Percentage of Participants With Grade 2 or Higher QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Prolongation After Receiving Quizartinib (Safety Analysis Set)|QT interval corrected for heart rate using Fridericia's formula (QTcF) grading was to be done according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 and the definition of Grade 2 or higher prolongation is QTcF more than 480 msec.|Evaluated at end of study, up to 6 months (approximately 3 years post treatment)|QTcF prolongation was assessed in the Safety Analysis Set.|||percentage of participants|||Number
2662071|NCT01565668|Secondary|Percentage of Participants Undergoing Hematopoietic Stem Cell Transplantation (HSCT) After Approximately 3 Years (Intent-to-Treat Population)|Transplantation rate was defined as the percentage of participants who underwent HSCT directly after treatment with quizartinib (no other intervening acute myeloid leukemia therapies other than conditioning regimens for the HSCT).|Evaluated at end of study, up to 6 months (approximately 3 years post treatment)|Transplantation rate was assessed in the intent-to-treat (ITT) analysis set.|||percentage of participants|||Number
2662072|NCT01565668|Secondary|Time to Composite Complete Remission (CRc) in Participants Who Achieved CRc After Approximately 3 Years (Intent-to-Treat Population)|Time to CRc was defined as the time from the date of randomization until the first disease assessment of CRc. Time to CRc was only evaluated in participants who achieved CRc.|Evaluated at end of study, up to 6 months (approximately 3 years post treatment)|Time to CRc was assessed in the intent-to-treat (ITT) analysis set.|||weeks||95% Confidence Interval|Median
2662073|NCT01565668|Secondary|Duration of Remission After Approximately 3 Years (Intent-to-Treat Population)|Duration of remission was defined as the time from first documented remission until documented relapse. CRc was defined as composite complete remission and CRi was defined as complete remission with incomplete hematological recovery.|Evaluated at end of study, up to 6 months (approximately 3 years post treatment)|Duration of remission was assessed in the intent-to-treat (ITT) analysis set.|||weeks||95% Confidence Interval|Median
2662074|NCT01565668|Secondary|Leukemia Free Survival (LFS) After Approximately 3 Years (Intent-to-Treat Population)|LFS was defined as the time from the date of first CRc until the date of documented relapse or death for participants who achieved CRc.|Evaluated at end of study, up to 6 months (approximately 3 years post treatment)|LFS was assessed in the intent-to-treat (ITT) analysis set.|||weeks||95% Confidence Interval|Median
2662075|NCT01565668|Secondary|Event Free Survival (EFS) After Approximately 3 Years (Intent-to-Treat Population)|EFS was defined as the time from the date of randomization until the date of documented relapse or death.|Evaluated at end of study, up to 6 months (approximately 3 years post treatment)|EFS was assessed in the intent-to-treat (ITT) analysis set.|||weeks||95% Confidence Interval|Median
2662076|NCT01565668|Secondary|Overall Survival (OS) After Approximately 3 Years (Intent-to-Treat Population)|OS was defined as the time from the date of randomization until the date of death from any cause.|Evaluated at end of study, up to 6 months (approximately 3 years post treatment)|OS was assessed in the intent-to-treat (ITT) analysis set.|||weeks||95% Confidence Interval|Median
2662077|NCT01565668|Secondary|Number of Participants Who Achieved Complete Remission (CR) (Intent-to-Treat Population)|Participant must have bone marrow regenerating normal hematopoietic cells and achieve a morphologic leukemia-free state (< 5% bone marrow blasts in bone marrow, no blasts with Auer rods and no persistence of extramedullary disease) and must have an absolute neutrophil count (ANC) ≥ 1x10^9/L and platelet count ≥ 100 x 10^9/L and they will be red blood cell (RBC) and platelet transfusion independent (defined as 4 weeks without RBC transfusions and 1 week without platelet transfusion).|At end of treatment visit (approximately 3 years post treatment)|Complete remission was assessed in the intent-to-treat (ITT) analysis set.|||Participants|||Count of Participants
2662078|NCT01565668|Primary|Number of Participants Who Achieved Composite Complete Response (CRc) (Intent-to-Treat Population)|"CRc is defined as Complete remission (CR) + Complete remission with incomplete platelet recovery (CRp) + Complete remission with incomplete hematological recovery (CRi).~Participants with CR must have normal hematopoietic cells and achieved a morphologic leukemia-free state (<5% bone marrow blasts in bone marrow, no blasts with Auer rods and no persistence of extramedullary disease) and must have had an absolute neutrophil count (ANC) ≥1 × 10^9/L and platelet count ≥100 × 10^9/L and were red blood cell (RBC) and platelet transfusion independent. Blasts in the peripheral blood was to be ≤1% (if blood sample was available).~Participants with CRp must have achieved CR except for incomplete platelet recovery (< 100 ×10^9/L).~Participants with CRi must have fulfilled all the criteria for CR except for incomplete hematological recovery with residual neutropenia <1 × 10^9/L with or without complete platelet recovery. RBC and platelet transfusion independence were not required."|At end of Cycle 2 (after two complete 28-day cycles post treatment)|Composite complete remission was assessed in the intent-to-treat (ITT) analysis set.|||Participants|||Count of Participants
2662079|NCT01565642|Secondary|Hospitalizations|Number and timing of transfer to hospital from nursing home care, measured as hospital transfers per 90 person-days of follow-up, with follow-up censored at death.|9 months||||Hospital transfers per 90 person-days|||Number
2662080|NCT01565642|Secondary|Hospice Referral|Number of participants with a referral to hospice services|9 months||||Participants|||Count of Participants
2662081|NCT01565642|Secondary|Frequency of Communication|Number of participants who report discussions of goals of care with providers -- physicians, nurse practitioners, physician assistants or nursing home staff -- counted during follow-up|9 months||||Participants|||Count of Participants
2662082|NCT01565642|Secondary|Quality of Dying|Quality of Dying in Long-term Care (QOD-LTC) instrument has 11 items in 3 subscales measuring personhood, closure and preparation for dying, for total scores ranging 5-55. Higher scores indicate better quality of the dying experience.|9 months|Decedents only--this measure applies only to residents who die during Follow-Up.|||units on a scale||Standard Deviation|Mean
2662083|NCT01565642|Secondary|Alzheimer Disease Related Quality of Life|The Alzheimer Disease Related Quality of Life scale (ADRQL) ranges from 0-100 with higher scores indicating better quality of life.|9 months|This measure applies only to those persons with dementia who remained alive through the 9 month follow-up. In addition there were 3 withdrawals from the study by 9 months. Thus the overall number of participants for this outcome measure are n=239 (n=302 after removal of 60 decedents and 3 withdrawn participants).|||units on a scale||Standard Deviation|Mean
2662084|NCT01565642|Secondary|Comfort in Dying|Comfort Assessment in Dying for Dementia (CAD-EOLD) includes 14 items rated on a 3 point scale, summed for a total potential score of 14-42. Higher scores indicate better comfort.|9 months|Decedents only--this outcome measure applies only to residents who die during Follow-Up.|||units on a scale||Standard Deviation|Mean
2662085|NCT01565642|Secondary|Satisfaction With Care|Satisfaction with Care at the End of Life in Dementia (SWC-EOLD) scale; 10 items rated 1-4 and summed with total potential range 10-40. Higher scores indicate better satisfaction.|9 months||||units on a scale||Standard Deviation|Mean
2662086|NCT01565642|Secondary|Number of Palliative Care Domains in Care Plan|Index score ranging from 0-10 with one point given for care plan addressing each domain: prognosis, goals of care, physical symptoms, emotional needs, spiritual needs, resuscitation, artificial feeding, intravenous fluids, antibiotics, hospitalization. Higher scores indicate better palliative care.|9 months||||units on a scale||Standard Deviation|Mean
2662087|NCT01565642|Primary|Quality of Communication and Decision-making|The Quality of Communication (QOC) score with its End of Life (EOL) subscale score. Scores range 0-10 on QOC and its subscales, with higher scores indicating better communication quality.|3 months||||units on a scale||Standard Deviation|Mean
2662088|NCT01565616|Post-Hoc|PROMIS-57 Scores Health Related Quality of Life|"Health related quality of life was measured with the 57 item Patient-Reported Outcomes Measurement Information System (PROMIS-57). The PROMIS-57 includes 8 domains of health. The domains of Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Satisfaction with Social Role, and Sleep Disturbances each include 8 items. Respondents indicate the degree to which statements about specific health issues are problematic on a scale of 1 to 5 and responses are converted to a t-score metric. A score of 50 is the mean score for the general population in the United States, with a standard deviation of 10. Scores above 50 indicate the topic of the domain is being experienced more than average while scores below 50 mean that it is less than average.~The domain of Pain Intensity is measured with a single item asking participants to rate their average pain on a scale from 0 (no pain) to 10 (worst imaginable pain). The raw mean score is used."|Baseline, 1 year after transplant|This outcome measure compared quality of life scores one year post-HCT to baseline in the 17 participants who completed the surveys.|||units on a scale||Standard Deviation|Mean
2662089|NCT01565616|Secondary|Transplant Related Outcomes|Common transplant related complications were monitored as a secondary outcome measure of this study. These transplant related complications include hepatic veno-occlusive disease (VOD), idiopathic pneumonia syndrome (IPS), central nervous system (CNS) toxicity complications of posterior reversible encephalopathy syndrome (PRES), hemorrhage, and seizures, cytomegalovirus (CMV) infection, adenovirus infection, Epstein-Barr virus (EBV) infection, post-transplant lymphoproliferative disease (PTLD), and invasive fungal infection.|1 year after transplant||||Participants|||Count of Participants
2662090|NCT01565616|Secondary|Time to Neutrophil and Platelet Engraftment|Time to neutrophil engraftment is defined as the first of 3 measurements on different days when the patient has an absolute neutrophil count of at least 500/µL after conditioning. Time to Platelet engraftment is defined as the first day of a minimum of 3 measurements on different days that the patient has achieved a platelet count > 50,000/µL, without receiving a platelet transfusion in the previous 7 days.|1 year after transplant||||Days||Full Range|Median
2662091|NCT01565616|Secondary|Overall Survival|Overall survival is defined as survival with or without sickle cell disease after hematopoietic cell transplantation (HCT).|1 year after transplant||||Participants|||Count of Participants
2662092|NCT01565616|Secondary|Chronic Graft Versus Host Disease (GVHD)|Chronic GVHD was graded according to the National Institutes of Health (NIH) 2014 Consensus Criteria Diagnosis and scoring the severity of chronic GVHD is determined by evaluating symptoms of the skin, nails, hair, mouth, eyes, genitalia, gastrointestinal tract, liver, lungs, muscles, fascia and joints, immune function as well as other symptoms such as ascites and neuropathy. Chronic GVHD is graded as mild, moderate or severe based on the number of organ sites impacted and the severity of symptoms.|1 year after transplant||||Participants|||Count of Participants
2662093|NCT01565616|Secondary|Acute Graft Versus Host Disease (GVHD)|"Acute GVHD was graded according to the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus criteria. Clinical manifestations of acute GVHD include skin, liver, and gastrointestinal symptoms. Grading of acute GVHD is determined by size of maculopapular rash, bilirubin and stool output. Acute GVHD grades range from 0 to 4 with 0 indicating no GVHD and 4 representing the most severe grade.~Grade II is defined as a maculopapular rash over 25-50% of body surface area (BSA), bilirubin of 3.1 to 6 mg/dL, and stool output of 1000-1500 mL/d (for adults).~Grade III is defined as a maculopapular rash over more than 50% of BSA, bilirubin of 6.1 to 15 mg/dL, and stool output of greater than 1500 mL/d (for adults).~Grade IV is defined as generalized erythroderma with bullous formation, bilirubin greater than 15 mg/dL, and severe abdominal pain with or without ileus."|1 year after transplant||||Participants|||Count of Participants
2662094|NCT01565616|Secondary|Graft Failure|Primary graft failure occurs when a transplant recipient does not achieve donor chimerism following a bone marrow transplant. Secondary graft failure occurs when graft fails after donor chimerism had initially occurred.|1 year after transplant||||Participants|||Count of Participants
2662095|NCT01565616|Primary|Event -Free Survival Rate|Event-free survival is defined as stable donor erythropoiesis with no new clinical evidence of sickle cell disease. Primary or late graft rejection, disease recurrence, and death are considered events for this endpoint.|1 year after transplant||||Participants|||Count of Participants
2662096|NCT01565564|Secondary|The Rate of Pregnancy-induced Hypertension.|Pregnancy-induced hypertension includes gestational hypertension and preeclampsia/eclampsia.|From enrolment at 24-28 gestational weeks till after delivery, an average of 12 weeks.||||participants|||Number
2662097|NCT01565564|Primary|The Rate of Macrosomia.|Macrosomia is defined as birthweight ≥ 4000 gram.|At the time of birth.||||participants|||Number
2662098|NCT01565551|Primary|Glasgow Outcome Scale Extended (GOSE)|The GOSE provides and overall measure of disability based on information on cognition, independence, employability, and social/community participation collected via structured interview. Individuals are described by one of the eight outcome categories: Dead (1); Vegetative State (2); Lower Severe Disability (3); Upper Severe Disability (4); Lower Moderate Disability (5); Upper Moderate Disability (6); Lower Good Recovery (7) and Upper Good Recovery (8). Good Recovery is defined as a score of 7-8, Moderate Disability is defined by a score of 5-6 and Severe Disability is defined by a score of 3-4.|6 Months Post-Injury||||Glasgow Outcome Scale Extended (GOSE)||Inter-Quartile Range|Median
2662099|NCT01565538|Secondary|Overall Survival||From date of randomization until the date of death from any cause, assessed until at least 12 months after randomization.||||months||95% Confidence Interval|Median
2662100|NCT01565538|Secondary|Best Tumor Response|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From the date of randomization, assessed every 6 weeks, until at least 12 months after randomization.||||participants|||Number
2662101|NCT01565538|Primary|Progression-Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From the date of randomization to the date of tumour progression or death from any cause, assessed until at least 12 months after randomization.||||months||95% Confidence Interval|Median
2662102|NCT01565382|Secondary|Overall Inter-reader Agreement - Fleiss' Kappa|Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Fleiss' kappa was calculated across all inter-reader comparisons.|50-60 min after injection|Seven private practice nuclear medicine physicians with no prior training in reading florbetapir-PET scans each rated 40 florbetapir-PET scans (7 readers x 40 scans = 280 scan reads)as either amyloid positive or negative.|||Fleiss' kappa|Participants||Number
2662103|NCT01565382|Primary|Inter-reader Agreement - Median Kappa Statistic|Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Simple kappa statistics were calculated for each reader versus the other 6 readers. Primary outcome measure was the median kappa of each reader versus the other 6 readers.|50-60 min after injection|Seven private practice nuclear medicine physicians with no prior training in reading florbetapir-PET scans each rated 40 florbetapir-PET scans (7 readers x 40 scans = 280 scan reads)as either amyloid positive or negative.|||median kappa|Participants||Number
2662104|NCT01565369|Secondary|Inter-reader Agreement|Percentage of individual scan reads that agreed or disagreed with the majority read across nine readers|50-60 min after injection|315 scans = 35 subjects x 9 readers|||percentage of scans|Participants||Number
2662105|NCT01565369|Primary|Specificity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque|Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Specificity will be calculated as the percent of true negatives (as determined by the reference standard, no or sparse amyloid plaque at autopsy) that are correctly identified as amyloid negative by the PET scan read. Reported as the median specificity of the nine readers.|50-60 min after injection|16 of the 35 subjects had none or sparse plaques at autopsy|||percentage of true negatives||Full Range|Median
2662106|NCT01565369|Primary|Sensitivity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque|Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Sensitivity will be calculated as the percent of true positives (as determined by the reference standard, moderate or frequent amyloid plaque at autopsy) that are correctly identified as amyloid positive by the PET scan read. Reported as the median sensitivity of the nine readers.|50-60 min after injection|19 of the 35 subjects had moderate or frequent plaques at autopsy|||percentage of true positives||Full Range|Median
2662107|NCT01565356|Secondary|Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation|Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported the results using a 5-point scale (0=no amyloid; 4=high levels of amyloid deposition). Results are reported as a weighted kappa statistic.|Scans acquired 30-40 min and 50-60 min post-injection||||weighted kappa||95% Confidence Interval|Number
2662108|NCT01565356|Primary|Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation|Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported as amyloid positive or amyloid negative. Results show the percentage of agreement between the majority read of 30-40 min scan and the majority read of the 50-60 min scan.|Scans acquired 30-40 min and 50-60 min after injection||||percentage of agreement|||Number
2662109|NCT01565343|Primary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.|50-70 min after injection|Due to poor subject positioning that resulted in an incomplete brain image on the retest image day, accurate quantitative analysis for one healthy control was not possible, and the subject was excluded from the SUVR-based analyses.|||SUVR||Standard Deviation|Mean
2662110|NCT01565330|Secondary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.|0-90 min after injection||||SUVR||Standard Deviation|Mean
2662111|NCT01565330|Primary|Florbetapir-PET Scan Quality|Visual evaluation of image quality by nuclear medicine specialist blinded to dose and clinical information; reported on a 5-point scale (5=excellent and 1=poor).|0-90 min after injection|One subject in the 370 MBq (10 mCi) AD Group did not complete all imaging time periods|||florbetapir scans|||Number
2662112|NCT01565291|Secondary|Precuneus to Cerebellum SUVR|Ratio of uptake in the precuneus to uptake in the cerebellum.|50-60 min after injection|4 subjects in AD group and 1 subject in the healthy elderly group were excluded due to poor placement and/or excessive movement in the scanner during the 200-minute procedure.|||SUVR||Standard Deviation|Mean
2662113|NCT01565291|Primary|Mean Cortical to Cerebellum SUVR|Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the cerebellum gray matter. Total scan length was 200 min.|50-60 min after injection|4 subjects in AD group and 1 subject in the healthy elderly group were excluded due to poor placement and/or excessive movement in the scanner during the 200-minute procedure.|||SUVR||Standard Deviation|Mean
2662114|NCT01565148|Secondary|Peak Plasma Concentration (Cmax)of iCo-007 After Multiple Injections|cmax|Baseline to month 12|The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12||||||
2662115|NCT01565148|Secondary|Duration of iCo-007 Treatment Effect|treatment effect as measured by VA and OCY thickness|Baseline to month 12|The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12||||||
2662116|NCT01565148|Secondary|Change in Retinal Thickness Measured|measured by OCT|Baseline to month 12|The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12||||||
2662117|NCT01565148|Secondary|Change in Retinal Thickness Measured by OCT From Baseline to Month 8|Group 1|Baseline to month 8|Some participants opted out of the month 8 OCT.|||microns||Standard Deviation|Mean
2662118|NCT01565148|Secondary|Change in VA From Baseline to Month 12|The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 12|Baseline to month 12|The study was terminated prior to month 12. No data was collected and 0 participants were analyzed at month 12||||||
2662177|NCT01564693|Primary|ACTIVATION/NON ACTIVATION OF SPECIFIC BRAIN AREAS, EVALUATED BY FUNCTIONAL MAGNETIC RESONANCE|We observed different BOLD signal in the region of the hypothalamus between the 3 groups. The BOLD signal and the activation/no activation areas were statistically analyzed by a specific statistical method (i.e., parametric mapping).|TIME 0 (BASELINE)||||BOLD||Standard Deviation|Mean
2662119|NCT01565148|Secondary|Number of Participants in a Given Study Arm Experiencing the Same Drug-related Serious Adverse Event as a Measure of Safety and Tolerability|Safety of repeated iCo-007 intravitreal injections in treatment of subjects with Diabetic Macular Edema (DME) as monotherapy and in combination with ranibizumab or laser photocoagulation. Serious consideration will be given if 2 or more patients in a particular treatment arm experience the same drug-related serious adverse event;|Baseline to month 8||||Participants|||Count of Participants
2662120|NCT01565148|Primary|Change in VA From Baseline to Month 8|The primary efficacy variable is the change in visual acuity (mean change in number of letters) from baseline to month 8|Baseline to month 8|The results are from the participants which completed the primary end point and for which the data is available.|||Letters||Standard Deviation|Mean
2662121|NCT01565083|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score|FACT-B questionnaire is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.|Baseline, thereafter every 3 cycles from Cycle 3 to Cycle 45 (each cycle = 21 days)|ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||units on a scale||Standard Deviation|Mean
2662122|NCT01565083|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Visual Analogue Scale (VAS) Score|EQ-5D VAS: participant rated questionnaire to assess health-related quality of life (QoL) in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, thereafter every 3 cycles from Cycle 3 to Cycle 45 (each cycle = 21 days)|ITT population. Here, 'Number of Participants Analyzed' signifies the number of participants evaluable for this outcome measure and 'n' signifies the number of participants evaluable at specified time point.|||units on a scale||Standard Deviation|Mean
2662123|NCT01565083|Secondary|Overall Survival (OS)|OS was defined as the time from first intake of any study medication to the date of death, regardless of the cause of death. Participants who were known to be alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study treatment, and participants with no post-baseline information were censored at the date of first study treatment plus 1 day. Participants who died due to any cause were considered as having an event. The median OS was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation.|Baseline until death (up to approximately 3.5 years)|ITT population|||months||95% Confidence Interval|Median
2662124|NCT01565083|Secondary|Percentage of Participants Who Died From Any Cause|Percentage of participants who died due to any cause was reported.|Baseline until death (up to approximately 3.5 years)|ITT population|||percentage of participants|||Number
2662125|NCT01565083|Secondary|Time to Progression (TTP) as Assessed by Investigator According to RECIST v 1.1|TTP was defined as the time from first intake of any study medication until the first radio-graphically documented PD as assessed by investigator according to RECIST v1.1. Participants who did not have a radio-graphically documented PD and had died due to reason other than PD were censored on the last available tumor assessment prior to the death date. Participants with no baseline or no tumor assessment after the baseline visit were censored on the date of first study treatment. PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Participants who had radio-graphically documented PD as assessed by investigator according to RECIST v1.1 were considered as having an event. The median TTP was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population|||months||95% Confidence Interval|Median
2662126|NCT01565083|Secondary|Percentage of Participants With Disease Progression as Assessed by Investigator According to RECIST v1.1|PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Percentage of participants with radio-graphically documented PD as assessed by investigator according to RECIST v1.1 was reported.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population|||percentage of participants|||Number
2662127|NCT01565083|Secondary|Progression-free Survival (PFS) as Assessed by Investigator According to RECIST v 1.1|PFS was defined as the time from first intake of any study medication until the first radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or death due to any cause, whichever occurred first. Participants with no PFS events were censored at the time of the last evaluable tumor assessment. Participants with no baseline or no tumor assessment after the baseline visit were censored on the date of first study treatment. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Participants who had radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or died due to any cause were considered as having an event. The median PFS was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population|||months||95% Confidence Interval|Median
2662176|NCT01564706|Primary|Whole Body Radiation Dosimetry|Radiation dose values (millisieverts/megabecquerel [mSv/MBq]) for regions of the whole body. Target organs included the adrenals, brain, breasts, gall bladder wall, lower large intestine wall, small intestine wall, stomach wall, upper large intestine wall, heart wall, kidneys, liver, lungs, muscle, ovaries, pancreas, osteogenic cells, skin, spleen, testes, thymus, thyroid, urinary bladder wall, uterus, and total body.|0-380 min after injection||||mSv/MBq||Standard Deviation|Mean
2662128|NCT01565083|Secondary|Percentage of Participants With Disease Progression as Assessed by Investigator According to RECIST v1.1 or Death From Any Cause|PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Percentage of participants with radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or death due to any cause was reported.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population|||percentage of participants|||Number
2662129|NCT01565083|Secondary|Duration of Response (DOR) as Assessed by Investigator According to RECIST v 1.1|DOR, in participants with a BOR of CR or PR, was defined as the period from the date of initial PR or CR until the date of PD or death from any cause. Participants with no documented PD or death after CR or PR were censored at the last date at which they were known to have had the CR or PR, respectively (regardless of the response at intermediate assessments). CR: the disappearance of all TLs and SA reduction to <10 mm for nodal TLs/ non-TLs. PR: >/=30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. The 95% CI was computed using log-log transformation.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population. Only participants with a BOR of CR or PR and with measurable disease at baseline were included in the analysis.|||months||95% Confidence Interval|Median
2662130|NCT01565083|Secondary|Time to Response as Assessed by Investigator According to RECIST v 1.1|For participants with a BOR of CR or PR, time to response = (Date of first confirmed CR/PR - Date of first study treatment) + 1. For participants without a CR or PR, time to response = (Date of adequate last tumor assessment - Date of first study treatment) + 1. For participant with no tumor assessment (or if all assessments were progressive disease [PD]) the censoring day was set to date of first study treatment +1. CR: the disappearance of all TLs and SA reduction to <10 mm for nodal TLs/ non-TLs. PR: >/=30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. The 95% CI was computed using log-log transformation.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population. Only participants with measurable disease at baseline were included in the analysis.|||months||95% Confidence Interval|Median
2662131|NCT01565083|Primary|Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|Tumor response was assessed by investigator according to RECIST v1.1. BOR was defined as percentage of participants with a confirmed complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total or pathological nodes (with short axis [SA] of at least (>/=) 15 millimeter [mm]) were identified as target lesions (TLs) and measured and recorded at baseline. A sum of diameters (longest for non-nodal lesions, SA for nodal lesions) for all TLs was calculated and reported as baseline sum of diameters (SD). All other lesions (or sites of disease) were identified as non-TLs. CR: disappearance of all TLs and SA reduction to less than (<) 10 mm for nodal TLs/ non-TLs. PR: >/=30 percent (%) decrease in SD of TLs, taking as reference baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. The 95% confidence interval (CI) was computed using Clopper-Pearson approach.|Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)|ITT population. Only participants with measurable disease at baseline were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2662132|NCT01564953|Secondary|Quality of Life|Quality of life measured by Chronic Obstructive Pulmonary Disease Assesment Test. Minimum score was 0 (no symptoms) and maximum score was 40 (many symptoms).|One year||||units on a scale||Full Range|Mean
2662133|NCT01564953|Secondary|Serum Calcium|Serum ionized calcium, in mmol/L|One year||||mmol/L||Standard Deviation|Mean
2662134|NCT01564953|Secondary|Serum Magnesium|Serum magnesium in plasma, in mmol/L|One year||||mmol/L||Standard Deviation|Mean
2662135|NCT01564953|Secondary|Lung Function Test|Forced expiratory ventilation in 1 second, in percent of predicted|one year||||percentage of predicted||Full Range|Mean
2662136|NCT01564953|Primary|Serum Vitamin D|vitamin D measured by p-25-hydroxy-vitamin D2 + D3, in mmol/L|one year||||mmol/L||Standard Deviation|Mean
2662137|NCT01564914|Secondary|Number of Patients Who Respond to Study Treatment According to Modified RANO Criteria (Objective Response Rate (ORR)).|Number of patients who respond to study treatment according to modified RANO criteria was calculated (Objective Response Rate (ORR)). Modified RANO criteria is defined as follows: The largest cross-sectional area on the T1-weighted contrast-enhanced images was selected and measured in 2 dimensions with linear measures on the baseline MRI axial sequence. In addition, the largest cross-sectional area of a contiguous hyperintense lesion on FLAIR sequences was measured on the baseline MRI axial sequence. All subsequent scans were compared against these baseline measures (for both CE and FLAIR). New foci of FLAIR signal abnormality were recorded on each subsequent evaluation. Response was scored.|Patients are scanned every 8 weeks|Nineteen patients had measurable disease at baseline and received at least one follow up scan and were evaluable for the secondary efficacy outcome measure of PFS by modified RANO criteria. None of the patients treated on this study had a reduction in tumor burden compared to baseline.|||Participants|||Count of Participants
2662138|NCT01564914|Secondary|Number of Participants With Adverse Events|Adverse event frequency per patient according to CTCAE version 4.0.|Patients were followed for at least 28 days after the last dose of TRC105 study drug for adverse events, an average of 4 months|Patients who received at least a portion of a dose of TRC105 and/or Bevacizumab|||Participants|||Count of Participants
2668476|NCT01505764|Secondary|Appetite.|Appetite measured by a visual analogue scale ASAS. Percentage of change day84-baseline|day 84|cancer cachexia patients|||percentage change||Standard Deviation|Mean
2662139|NCT01564914|Secondary|Median Duration That Patients Remained Progression Free on Study|The median number of months that patients remained progression free was calculated using modified RANO criteria to determine progression. Modified RANO criteria is defined as follows: The largest cross-sectional area on the T1-weighted contrast-enhanced images was selected and measured in 2 dimensions with linear measures on the baseline MRI axial sequence. In addition, the largest cross-sectional area of a contiguous hyperintense lesion on FLAIR sequences was measured on the baseline MRI axial sequence. All subsequent scans were compared against these baseline measures (for both CE and FLAIR). New foci of FLAIR signal abnormality were recorded on each subsequent evaluation. Response was scored.|Patients are scanned every 8 weeks for approximately 6 months|Patients with at least 1 on study scan were included in the efficacy population. The number of months that patients remained progression free was calculated for 5 evaluable monotherapy patients and 14 evaluable combination therapy patients.|||months||95% Confidence Interval|Median
2662140|NCT01564914|Primary|Median Overall Survival (OS)|Overall survival assessed by determination from time of informed consent on trial to the date of death of each patient enrolled in the trial|6 Months|Patients treated with TRC105 and bevacizumab who expired. Overall survival was not captured in the monotherapy portion of the study.|||months||95% Confidence Interval|Median
2662141|NCT01564862|Secondary|Change From Baseline to Week 8 in the Clinical Global Impressions-Severity (CGI-S) Score|"The CGI-S assesses the clinician's impression of the subject's current state of mental illness and consists of one question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill). A MMRM model with baseline*week, center, week, treatment and week*treatment as factors was used for analyses."|Baseline, Week 1, Week 4 and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy,with data available for analysis. Repeated Measures Analysis.|||score on a scale||Standard Error|Least Squares Mean
2662142|NCT01564862|Secondary|Percentage of Participants in MADRS Remission at Week 8|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. MADRS Remission was defined as a MADRS total score ≤10.|Week 8|Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Last Observation Carried Forward.|||percentage of participants|||Number
2662143|NCT01564862|Secondary|Percentage of Participants With MADRS Response at Week 8|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. MADRS Response was defined as a ≥50% decrease in MADRS Total Score from Baseline.|Baseline and Week 8|Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Last Observation Carried Forward.|||percentage of participants|||Number
2662144|NCT01564862|Secondary|Change From Baseline to Week 8 in the MADRS Total Score|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement.|Baseline, Week 1, Week 4 and Week 8|Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Last Observation Carried Forward.|||score on a scale||Standard Deviation|Mean
2662145|NCT01564862|Secondary|Proportion of Cognitive Dysfunction Improvement Due to Improvement of Depression|Improvement of Cognitive Dysfunction is determined using the change from Baseline to Week 8 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score and the Digital Symbol Substitution Test (DSST) total number of correct symbols. The MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression). The DSST assesses relative contributions of speed, memory, executive function and visual scanning. The proportion of direct effect from treatment = DSST difference / (DSST difference + coefficient*MADRS difference).|Baseline and Week 8|Full Analysis Set included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment.|||proportion of direct effect|||Number
2662146|NCT01564862|Secondary|Change From Baseline to Week 8 in the One-Back Task|The One-Back test measures the cognitive domain of attention and working memory through yes or no responses to 30 trials. The task requires participants to report when a stimulus item presented serially is the same as an item one step back from the item at hand for a total correct responses 0 to 100. It usually takes 2-3 minutes to be administered. Higher scores equal better performance. An increase in score over the course of the study indicates improved attention/working memory. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.|||Log 10 milliseconds||Standard Error|Least Squares Mean
2662147|NCT01564862|Secondary|Change From Baseline to Week 8 in the Identification Task (IT)|"The IT measured choice reaction time: the participant pressed a yes button whenever an onscreen playing card turned face up and was red, or a no button if the card was not red. The IT took on average 2 minutes to complete. Lower scores equal better performance. A decrease in score over the course of the study indicates improved visual attention/vigilance. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate."|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.|||Log10 milliseconds||Standard Error|Least Squares Mean
2662148|NCT01564862|Secondary|Change From Baseline to Week 8 in the Detection Task (DT)|"The DT is a computerized test that measures simple reaction time and psychomotor speed. The task requires participants to respond by pressing a yes button as soon as an onscreen playing card is turned over and is red, and by pressing a no button if the card is not red. It takes 2 minutes to be administered. There is no minimum or maximum scores since it is a time-based assessment. Lower score equals better performance. A decrease in score over the course of the study indicates improved speed of processing and psychomotor function. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate."|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.|||Log10 milliseconds||Standard Error|Least Squares Mean
2662149|NCT01564862|Secondary|Change From Baseline to Week 8 in the Groton Maze Learning Test (GMLT)|"The GMLT measures executive functioning and spatial problem solving. Participants learn a hidden pathway through a maze of 10 x 10 grid of tiles on a computer touch screen using step-by-step guess, with trial and error feedback after each step. Once the pathway is learned, participants repeat the same pathway four more times. It usually takes 5-6 minutes to administer this test. Lower score equals better performance. A decrease in score over the course of the study indicates improved executive function.~An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate."|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.|||Errors||Standard Error|Least Squares Mean
2662150|NCT01564862|Secondary|Change in Time From Baseline to Week 8 in the Stroop Test|The STROOP test assesses the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. It comprises of 2 sheets with 50 words each, up to 50 correct responses for each of the congruent and incongruent Stroop tests. Participants have 4 minutes to name the ink color of each word. Lower time to complete the test indicates better performance. Higher number of correct responses indicates better responses. A decrease in the time to complete the tests and an increase in the number of correct responses both indicate improvement over the course of the study. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.|||seconds||Standard Deviation|Mean
2662151|NCT01564862|Secondary|Change From Baseline to Week 8 in the Trail Making Test B (TMT-B)|The TMT is a two-part cognitive test. TMT-B assesses executive functioning and consists of 25 circles distributed over a sheet of paper. Participants have 4 minutes to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Tester informs participant immediately whenever they make an error and allows for corrections by participants. Lower score for TMT-B represents better executive function. A decrease in score over the study represents an improvement in executive function. An ANCOVA model was used with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.|||seconds||Standard Error|Least Squares Mean
2662152|NCT01564862|Secondary|Change From Baseline to Week 8 in the Trail Making Test (TMT-A)|The TMT is a two-part cognitive test. TMT-A assesses cognitive processing speed and consists of 25 circles distributed over a sheet of paper. Participants have 4 minutes to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Tester informs participant immediately whenever they make an error and allows for corrections by participants. Lower scores represent better speed of processing. A decrease in score over the study represents an improvement in speed in processing. An ANCOVA model was used with treatment and center as fixed factors and the baseline value as a covariate.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.|||seconds||Standard Error|Least Squares Mean
2662153|NCT01564862|Secondary|Clinical Global Impressions-Improvement (CGI-I) Score at Week 8|"The CGI-I assesses the clinician's impression of the subject's state of mental illness improvement and consists of one question for the investigator: Compared to his condition at the start of the study, how much has this patient changed? which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change relative to baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater worsening of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. A MMRM model was used with baseline*week, center, week, treatment and week*treatment as factors in the analysis."|Baseline, Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analysis.|||score on a scale||Standard Error|Least Squares Mean
2662154|NCT01564862|Secondary|Change From Baseline to Week 8 in the Perceived Deficits Questionnaire (PDQ) Attention/Concentration and Planning/Organization Subscore|PDQ is a patient-rated scale designed to subjectively assess cognitive dysfunction, comprising four 5-item subscales: Attention/Concentration, Retrospective Memory, Prospective Memory, and Planning/Organization for a total possible score of 0 to 40. The subscale Attention/Concentration is the sum of items 1, 5, 9, 13, and 17 with a range of 0-20; while the subscale Planning/Organization is the sum of items 4, 8, 12, 16, and 20 with the score range of 0 to 20. The scores of the subscales Attention/Concentration and Planning/Organization were summed. Higher scores reflect greater participant-perceived cognitive dysfunction in the domains identified. A decrease in score represents an improvement in subjective cognitive function in the domains identified. A Mixed Model Repeated Measures (MMRM) model was used with baseline*week, center, week, treatment and week*treatment as factors in the analysis.|Baseline and Week 8|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy,with data available for analysis.|||score on a scale||Standard Error|Least Squares Mean
2662155|NCT01564862|Primary|Change From Baseline to Week 8 in the Digit Symbol Substitution Test (DSST)|The DSST assesses relative contributions of speed, memory, executive function and visual scanning. Participants are required to copy symbols that are paired with simple geometric shapes or numbers within a specific time for a total possible score of 0 to 133. Higher scores-correct number of symbols reflects greater objective cognitive functioning. An increase in score represents an improvement in an integrated measure of cognitive function. An Analysis of Covariance (ANCOVA) model was used with treatment and center as fixed factors and the Baseline value as a covariate.|Baseline and Week 8|Full Analysis Set included all randomized participants who received at least one dose of study drug and had at least 1 valid post-baseline value for assessment of primary efficacy. Participants with scores of > 70 at Baseline were excluded.|||Correct symbols||Standard Error|Least Squares Mean
2662156|NCT01564784|Secondary|Percentage of Participants With Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Following Post Study HSCT|VOD/SOS was defined as the occurrence of 2 out of the following 3 clinical criteria: 1) total serum bilirubin level >34 micromoles per liter (μmol/L) (>2.0 milligrams per deciliter [mg/dL]), 2) an increase in liver size from baseline or development of right upper quadrant pain of liver origin and 3) sudden weight gain >2.5% (eg, within a 72 hour period) because of fluid accumulation in the weeks following infusion of study drug or chemotherapy, or HSCT conditioning/preparative therapy, or development of ascites not present at baseline following such exposures AND the absence of other explanations for these signs and symptoms, OR development of bilirubin elevation, weight gain, or hepatomegaly plus histologic abnormalities on liver biopsy demonstrating hepatocyte necrosis in zone 3 of the liver acinus, sinusoidal fibrosis, and centrilobular hemorrhage, with or without fibrosis of the terminal hepatic venules.|Up to 2 years from randomization|Participants in the Safety population with post-study HSCT. A site visit in July 2017 (after clinical database lock), confirmed a fourth case of VOD/SOS occurred in the Defined Investigators Choice of Chemotherapy arm in March 2013 (approximately 3 months after the last dose).This was not entered on the CRF and therefore, is not included below.|||Percentage of Participants|||Number
2662157|NCT01564784|Secondary|Change From Baseline in EQ-5D VAS|"The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting no problems, some problems, and extreme problems. The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state."|Day 1 of each cycle prior to dosing and EoT|ITT population. Although only 143 participants were treated in the Defined Investigator’s Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population.|||Score on a scale||Standard Error|Mean
2662158|NCT01564784|Secondary|Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score|"The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting no problems, some problems, and extreme problems. The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health)."|Day 1 of each cycle prior to dosing and EoT|ITT population. Although only 143 participants were treated in the Defined Investigator’s Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population.|||Score on a scale||Standard Error|Mean
2662159|NCT01564784|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score|This questionnaire comprised 30 questions within which are 9 multi-item scales & 6 single-item measures. There are 5 functional scales; physical, role, cognitive, emotional & social, 3 symptom scales; fatigue, pain, & nausea & vomiting, & a global health status/quality of life (QoL) scale. There are 5 single item measures assessing additional symptoms commonly reported by cancer patients (loss of appetite, insomnia, constipation, diarrhea, & dyspnea) & a single item concerning perceived financial impact of the disease. Most questions used a 4 point scale (1='not at all' to 4='very much'); 2 questions used a 7-point scale (1='very poor' to 7='excellent'). Scores were averaged & transformed to a scale ranging from 0 to 100; a higher score indicates a better level of functioning or greater degree of symptoms.|Day 1 of each cycle prior to dosing and EoT|ITT population. Although only 143 participants were treated in the Defined Investigator’s Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population|||Score on a scale||Standard Error|Mean
2662160|NCT01564784|Secondary|Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) and Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing|Blood samples were collected and analyzed for inotuzumab ozogamicin serum concentrations using a validated high performance liquid chromatography with tandem mass spectrometry (HPLC/MS/MS) method with a lower limit of quantification of 1.0 nanograms per milliliter (ng/mL). Cmax was the maximum observed concentration occurring between 0-8 hours post-dose. Ctrough was the concentration prior to subsequent dose (pre-dose) occurring after 8 hours. n = number of observations (non-missing concentrations).|Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4|Pharmacokinetic (PK) evaluable population - included all participants with available PK data.|||ng/mL||Standard Deviation|Mean
2662161|NCT01564784|Secondary|Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment)|Karyotyping was required locally, at screening and at least once during the study in participants who had abnormal cytogenetics at baseline and who achieved CR/CRi. Data presented below are for participants who achieved CR/CRi per EAC and had abnormal karyotype at screening.|Up to approximately 4 weeks (EoT) from last dose of study drug|Participants in the ITT218 population who had abnormal cytogenetics at baseline and who achieved CR/CRi|||Percentage of Participants||95% Confidence Interval|Number
2662992|NCT01557166|Secondary|Change From Baseline in Body Weight (kg)|Observed mean change from baseline in fasting body weight (kg) after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) - included all randomised subjects. 353 subjects contributed to the statistical analysis.|||kg||Standard Deviation|Mean
2662162|NCT01564784|Secondary|Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment)|MRD analysis was performed at least once in participants with prior assessment of CR or CRi. Bone marrow aspirates, collected at screening and during the study, were sent to the central laboratory and analyzed using multiparametric flow cytometry. The antibody combinations were designed to maximize discrimination between normal and abnormal cells of B-cell lineage and similar maturational stage and included antibodies detecting cluster of differentiation (CD) 9, CD10, CD13, CD19, CD20, CD33, CD34, CD38, CD45, CD58, CD66c, and CD123. A peripheral blood sample was provided if a participant had an inadequate bone marrow aspirate at screening. MRD negativity was considered to have been achieved if the lowest value of MRD from the first date of CR/CRi to EoT was <1 × 10^-4 blasts/nucleated cells.|Up to approximately 4 weeks (EoT) from last dose of study drug|Participants in the ITT218 population achieving CR/CRi (per EAC Assessment)|||Percentage of Participants||95% Confidence Interval|Number
2662163|NCT01564784|Secondary|Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT)|HSCT rate was defined as the percentage of participants who underwent SCT following treatment with inotuzumab ozogamicin or Investigator's choice of chemotherapy.|Up to 19 weeks from last dose|ITT population. Although only 143 participants were treated in the Defined Investigator’s Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population.|||Percentage of Participants||95% Confidence Interval|Number
2662164|NCT01564784|Secondary|Progression-Free Survival (PFS)|PFS was defined as time from date of randomization to earliest date of the following events: death, progressive disease (objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status) and starting new induction therapy or post-therapy SCT without achieving CR/CRi. Participants without a PFS event at time of analysis were censored at the last valid disease assessment. In addition, participants with documentation of an event after an unacceptably long interval (>28 weeks if there was post-baseline disease assessment, or >12 weeks if there was no post-baseline assessment) since the previous disease assessment were censored at the time of the previous assessment (date of randomization if no post-baseline assessment). Post-study treatment follow-up disease assessments was included. Kaplan-Meier method used and 2-sided 95% confidence interval (CI) calculated based on the Brookmeyer and Crowley method.|Up to 2 years from randomization|ITT population. Although only 143 participants were treated in the Defined Investigator’s Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population.|||Months||95% Confidence Interval|Median
2662165|NCT01564784|Secondary|Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment)|DoR was defined as time from date of first response in responders (CR/CRi per Investigator assessment) to date of PFS event (i.e. death, progressive disease [objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status] or starting new induction therapy or post-therapy stem cell transplant [SCT] without achieving CR/CRi). Responders without PFS events were censored at the last valid disease assessment including follow-up.|Up to 2 years from randomization|Participants in the ITT218 population who achieved CR/CRi|||Months||95% Confidence Interval|Median
2662166|NCT01564784|Primary|Overall Survival (OS)|OS was defined as the time from randomization to date of death due to any cause. Participants last known to be alive were censored at date of last contact.|Up to 5 years after randomization or 2 years from randomization of the last participant, whichever occurs first.|ITT population - included all participants randomized. Although only 143 participants were treated in the Defined Investigator’s Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population.|||Months||95% Confidence Interval|Median
2662167|NCT01564784|Primary|Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC)|CR was the disappearance of leukemia indicated by less than (<) 5 percent (%) marrow blasts & absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) greater than or equal to (≥)1000 per microliter (/μL) & platelets ≥100,000/μL. C1 extramedullary disease status (i.e. complete disappearance of measurable & non-measurable extramedullary disease with the following exceptions: for participants with at least 1 measurable lesion, all nodal masses greater than (>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) at baseline must have regressed to less than or equal to (≤) 1.5 cm in GTD; all nodal masses ≥1 cm & ≤1.5 cm in GTD at baseline must have regressed to <1 cm GTD or reduced by 75% in sum of products of greatest diameters, no new lesions, spleen & other previously enlarged organs must have regressed in size & must not be palpable) was required. CRi was defined as CR except ANC <1000/μL &/or platelets <100,000/μL.|Screening, Day 16 to 28 of Cycles 1, 2 and 3, then every 1 to 2 cycles (or as clinically indicated) up to approximately 4 weeks (end of treatment [EoT]) from the last dose|ITT218 population - included the ITT population (all participants randomized) for the initial 218 participants.|||Percentage of Participants||95% Confidence Interval|Number
2662168|NCT01564758|Secondary|Number of Participants With Clinical Response|Clinical response assessed by Investigator at EOT visit as Cure: complete resolution of signs or symptoms of infection and no need to start another antibiotic. Improvement: incomplete resolution of signs or symptoms of infection but no need to start another antibiotic. Failure: death, or need to start another antibiotic. For participants previously assessed as failures, the outcome was failure at subsequent time points.|EOT (Day 10 up to 28)|Efficacy was evaluated for the safety analysis set which included all the participants who received at least 1 dose of study medication|||participants|||Number
2662169|NCT01564758|Primary|Number of Participants With Adverse Events (AEs)|Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.|Baseline up to End of Treatment (EOT) (Day 10 up to 28)|Safety analysis set included all the participants who received at least 1 dose of study medication.|||participants|||Number
2662170|NCT01564732|Secondary|Quantitative Change in Hypertriglyceridemia|Triglyceride levels will be measured annually for 3 years and the change in preoperative and postoperative levels will be determined. We will also assess the need for medications to treat hypertriglyceridemia before and after surgery.|36 months|Data not collected.||||||
2662171|NCT01564732|Secondary|Quantitative Change in Hyperlipidemia|Lipid levels will be measured annually for 3 years and the change in preoperative and postoperative levels will be determined. We will also assess the need for medications to treat hyperlipidemia before and after surgery.|36 months|Data not collected.||||||
2662178|NCT01564628|Primary|The Area Under the Receiver Operating Characteristic Curve of the CAD-score to Separate CAD From Non-CAD Patients.|"Cardiac noise marker (CAD-score) ability to separate CAD from non-CAD patients is estimated as the area under the receiver operating characteristic curve.~The area under the receiver operating characteristic curve is plottet as sensitivity versus 1-specificity as a function of different CAD-score cut-off values.~The area under the receiver operating characteristic curve is on a scale from 0-100%, the higher value means a better separation of CAD from non-CAD patients.~CAD and non-CAD patients are defined by the CTA and CAG evaluations."|Heart sound recordings measured on testday (25 minutes study period)|Per protocol analysis|||percentage of 100||95% Confidence Interval|Mean
2662179|NCT01564537|Secondary|Association Between Response or Resistance to Ixazomib Treatment and Proteasome and Nuclear Factor-kB (NF-kB)-Related Genes||At the time of screening; Day 1 of each cycle; at EOT; every 4 weeks until disease progression and thereafter every 12 weeks until death or study termination||2020-12-31|12/2020||||
2662180|NCT01564537|Secondary|Pharmacokinetic Parameters (Including Cmax, AUC and Tmax) of Ixazomib||Days 1 & 14 of Cycles 1 & 2. Day 1 of Cycles 3 to 10||2020-12-31|12/2020||||
2662181|NCT01564537|Secondary|PFS in High-Risk Participants|Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first. Response was assessed by independent review committee (IRC) using IMWG response criteria. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are no longer considered to be high-risk abnormalities and are not included in the analysis.|From date of randomization until disease progression or death up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|Participants from the ITT population, all randomized participants, with cytogenic abnormalities.|||months||95% Confidence Interval|Median
2662182|NCT01564537|Secondary|OS in High-Risk Participants|Overall survival (OS) is defined as the time from the date of randomization to the date of death. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are no longer considered to be high-risk abnormalities and are not included in the analysis. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.|At the time of screening; Day 1 of each cycle; every 4 weeks until disease progression and thereafter every 12 weeks until death or study termination||2020-12-31|12/2020||||
2662183|NCT01564537|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Multiple Myeloma Module (QLQ-MY-20)|The EORTC-QLQ-MY-20 is a patient-completed, 20-question quality of life questionnaire that has 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). The participant answers questions about their health during the past week using a 4-point scale where 1=Not at All to 4=Very Much. A negative change from Baseline indicates improvement.|Baseline and Every 2 Cycles beginning with Cycle 2 during treatment period, End of Treatment (EOT), and every 4 Weeks in follow-up||2020-12-31|12/2020||||
2662184|NCT01564537|Secondary|Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) Questionnaire (EORTC-QLQ-C30)|The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer participants. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).The EORTC-QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement.|Baseline and Every 2 Cycles beginning with Cycle 2 during treatment period, End of Treatment (EOT), and every 4 Weeks in follow-up||2020-12-31|12/2020||||
2662185|NCT01564537|Secondary|Percentage of Participants Achieving Pain Response|"Pain response was defined as 30% reduction from Baseline in Brief Pain Inventory-Short Form (BPI-SF) worst pain score over the last 24 hours without an increase in analgesic (oral morphine equivalents) use at 2 consecutive evaluations. The BPI-SF contains 15 items designed to capture the pain severity (worst, least, average, and now [current pain]), pain location, medication to relieve the pain, and the interference of pain with various daily activities including general activity, mood, walking activity, normal work, relations with other people, sleep, and enjoyment of life. The pain severity items are rated on a 0 to 10 scale where: 0=no pain and 10=pain as bad as you can imagine and averaged for a total score of 0 (best) to 10 (Worst)."|At screening; Day 1 of each cycle; and thereafter every 4 weeks until disease progression||2020-12-31|12/2020||||
2662186|NCT01564537|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Eastern Cooperative Oncology Group (ECOG) performance score, laboratory values, vital sign measurements and reported adverse events (AEs) were collected and assessed to evaluate the safety of therapy throughout the study. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|From the date of signing of the informed consent form through 30 days after the last dose of study drug up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|Safety population included all randomized participants who received at least 1 dose of ixazomib.|||participants|||Number
2662590|NCT01561313|Secondary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|The secondary response variable is participant's pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm) recorded 15 minutes after the injection, with 0 representing no pain and 10 representing the worst possible pain.|15 minutes post injection||||cm||Standard Deviation|Mean
2662187|NCT01564537|Secondary|Time to Progression (TTP) as Assessed by the IRC|TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD) as assessed by the IRC using IMWG criteria.|Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|ITT population included all randomized participants|||months||95% Confidence Interval|Median
2662188|NCT01564537|Secondary|Duration of Response (DOR)|DOR was measured as the time in months from the date of first documentation of a confirmed response of PR or better (CR [including sCR] + PR+ VGPR) to the date of the first documented disease progression (PD) among participants who responded to the treatment. Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria.|Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|Response-Evaluable population included all participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post-baseline response assessment, all responders.|||months||95% Confidence Interval|Median
2662189|NCT01564537|Secondary|Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) as Assessed by the IRC|Response was assessed by the IRC using International Myeloma Working Group (IMWG) Criteria. CR is defined as negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; < 5% plasma cells in bone marrow. VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours.|Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|ITT population included all randomized participants.|||percentage of participants|||Number
2662190|NCT01564537|Secondary|Overall Response Rate (ORR) as Assessed by the IRC|ORR was defined as the percentage of participants with Complete Response (CR) including stringent complete response (sCR), very good partial response (VGPR) and Partial Response (PR) assessed by the IRC using IMWG criteria.|Day 1 of each cycle (every 4 weeks) until disease progression up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|ITT population included all randomized participants.|||percentage of participants|||Number
2662191|NCT01564537|Secondary|Overall Survival in High-Risk Participants Carrying Deletion 17 [Del(17)]|Overall survival is defined as the time from the date of randomization to the date of death. The high-risk participants whose myeloma carried del(17) subgroup was defined as the cases reported as positive for del(17) by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17) by local laboratory. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.|At the time of screening; Day 1 of each cycle (every 4 weeks) until disease progression and thereafter every 12 weeks until death or study termination||2020-12-31|12/2020||||
2662192|NCT01564537|Secondary|Overall Survival (OS)|Overall survival is defined as the time from the date of randomization to the date of death. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.|Date of randomization until death up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|ITT population was defined as all randomized participants.|||months||95% Confidence Interval|Median
2662193|NCT01564537|Primary|Progression Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)|Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression (PD) or death due to any cause, whichever occurs first. Response including PD was assessed by independent review committee (IRC) using the International Myeloma Working Group (IMWG) response criteria. PD requires 1 of the following: Increase of ≥ 25% from nadir in: Serum M-component (absolute increase ≥ 0.5 g/dl); Urine M-component (absolute increase ≥ 200 mg/24 hours); In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 10 mg/dl); Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease. Status evaluated every 4 weeks until disease progression (PD) was confirmed.|From date of randomization until disease progression or death up to data cut-off: 30 October 2014 (approximate median follow-up 15 months)|Intent-to-Treat (ITT) population was defined as all randomized participants.|||months||95% Confidence Interval|Median
2662194|NCT01564459|Primary|Percentage of Participants Who Were Discontinued Form the Study Due to an AE|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. Adverse Events that were reported as the cause for discontinuation of the study drug were recorded.|up to 7 days for run-in; up to 14 days for active treatment period)|All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.|||Percentage of Participants|||Number
2662195|NCT01564459|Primary|Percentage of Participants Who Experienced 1 or More Adverse Events (AE)|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE.|up to 42 days (up to 14 days for run-in; up to 28 days for active treatment period)|All participants who received at least 1 dose of study drug. One participant who was randomly assigned to placebo for double-blind treatment period actually received MK-6096 10 mg. AEs are reported by treatment received and not by randomly assigned treatment arm.|||Percentage of Participants|||Number
2662207|NCT01564394|Primary|FACIT-Fatigue Change From Baseline to 13-weeks.|Our primary outcome of change in fatigue was assessed with the Functional Assessment Chronic Illness Therapy (FACIT)-Fatigue scale. This 13-item scale assesses levels of fatigue during daily activities over the past seven days. Higher scores indicate less fatigue (score range = 0 - 52). Positive change scores indicate improved fatigue.|Baseline to 13-weeks|Data is presented for Qigong participants (n=16) and family members (n=8 ) and for Stretching participants (n=13) and family members (n=7) .|||Units on scale||Inter-Quartile Range|Median
2662196|NCT01564459|Secondary|Change in Pain Intensity Scores - All Responders|Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant's average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A responder was defined as a participant who had a ≥20% decrease in treatment baseline score relative to run-in baseline score. The final value was the participant's average evening pain intensity score over the last 3 days of treatment period. The change in the final average evening pain intensity score from treatment baseline was summarized for the responders.|End of Single-Blind Period (Baseline) and end of Double-Blind Period|All randomized participants (continued into double-blind treatment period) who met criteria as a responder.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2662197|NCT01564459|Secondary|Change in Pain Intensity Scores - Primary Responders|Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant's average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A primary responder was defined as a participant who had a ≥30% decrease in treatment baseline score relative to run-in baseline score. The final value was the participant's average evening pain intensity score over the last 3 days of treatment period. The change in the final average evening pain intensity score from treatment baseline was summarized for the primary responders.|End of Single-Blind Period (Baseline) and end of Double-Blind Period|All randomized participants (continued into double-blind treatment period) who met criteria as a primary responder.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2662198|NCT01564459|Secondary|TTEF - All Responders|Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant's average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A responder was defined as a participant who had a ≥20% decrease in treatment baseline score relative to run-in baseline score. Efficacy failure was defined as an occurrence of 3 consecutive days, or 4 days in a row with only one day missing and the other 3 days with a daily evening pain intensity score ≥4 and an increase of ≥20% in daily evening pain intensity score relative to treatment baseline score. The time to efficacy failure for responders was summarized.|Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days)|All randomized participants (continued into double-blind treatment period) who met criteria as a responder.|||Days||95% Confidence Interval|Median
2662199|NCT01564459|Primary|Time to Efficacy Failure (TTEF) - Primary Responders|Participants rated their pain twice daily using a 0 to 10 scale with 0=no pain and 10=worst pain you can imagine. The participant's average evening pain intensity scores over the last 3 days of screening period and of run-in period were defined as the run-in baseline score and treatment baseline score, respectively. A primary responder was defined as a participant who had a ≥30% decrease in treatment baseline score relative to run-in baseline score. Efficacy failure was defined as an occurrence of 3 consecutive days, or 4 days in a row with only one day missing and the other 3 days with a daily evening pain intensity score ≥4 and an increase of ≥30% in daily evening pain intensity score relative to treatment baseline score. The time to efficacy failure for primary responders was summarized.|Day 1 of double-blind treatment phase to the first documented efficacy failure (up to 28 days)|All randomized participants (continued into double-blind treatment period) who met criteria as a primary responder.|||Days||95% Confidence Interval|Median
2662200|NCT01564407|Secondary|Quality of Life Measurement - Satisfaction With Appearance Scale (SWAP)|SWAP is a psychological test for personality diagnosis. there are 9 questions evaluated by a score of 7 (most descriptive to the patient) to 0 (not descriptive or irrelevant) for a total scoring range of 0-63.|12 weeks||||units on a scale||Standard Deviation|Mean
2662201|NCT01564407|Secondary|Disability Index-Disability of Arm, Shoulder and Hand|The six subjects suffering from upper extremity and cervical scar contractures were evaluated with the Disability of Arm, Shoulder and Hand (DASH) questionnaire. The DASH questionnaire evaluates symptoms and functional status. A lowest score of 0 indicates normal skin and highest score of 100 represents the greatest possible morbidity.|12 weeks||||scores on a scale||Standard Deviation|Mean
2662202|NCT01564407|Secondary|Patient and Observer Scar Assessment Scale (POSAS)|POSAS aims to measure scar quality, it is a comprehensive scale designed for the evaluation of all types of scars by professionals and patients. It contains two scales with six items, scored numerically from 0-10, where 0 is normal skin and 10 is the worst scar imaginable. the total scoring range is from 0-120.|12 weeks||||scores on a scale||Standard Deviation|Mean
2662203|NCT01564407|Secondary|Vancouver Scar Scale|Vancouver scar scale will be evaluated for each cohort. The Vancouver scar scale is the most frequently cited assessment of scar severity used in clinical studies. Pigmentation, vascularity, pliability, and scar height are graded producing a composite score. A score of 0 represents normal skin with higher grades representing greater deformity with a maximum possible rating of 14.|12 weeks||||scores on a scale||Standard Deviation|Mean
2662204|NCT01564407|Secondary|Percentage of Subjects Worse Hypertrophic Scars|The secondary objectives of this study are to evaluate improvement in symptoms of hypertrophic scars.|Endpoints assessed at Day 84.||||percentage of paricipants|||Number
2662205|NCT01564407|Primary|Number of Participants With Serious Adverse Events Reported|The evaluation of tolerability of ICX-RHY-013 in the treatment of stable, restrictive hypertrophic scars through regular assessment of adverse events.|12 weeks||||participants|||Number
2662206|NCT01564407|Primary|Number of Participants With Adverse Events|The evaluation of safety of ICX-RHY-013 in the treatment of stable, restrictive hypertrophic scars through assessment of adverse events. The primary objective of the safety (no injection) cohort is to evaluate initial safety of multiple doses through assessment of adverse events. The primary objective of remaining cohorts is to evaluate the ongoing safety of ICX-RHY-013 in post-burn hypertrophic scars that are not planned for excision through assessment of adverse events.|Days 0, 7, 14, 28, 56, 84||||participants|||Number
2662208|NCT01564394|Primary|Attendance Rates in Study (Feasibility Outcome)|The class attendance rates were the number of classes attended by participants divided by the total number of classes offered. Range of attendance rate is 0 to 1. Prostate cancer survivors were the population targeted in this intervention, therefore, the retention and attendance rates only include prostate cancer survivors (i.e., family members were not included in these calculations).|13-weeks||||Proportion of classes|||Number
2662209|NCT01564394|Primary|Retention Rate in Study (Feasibility Outcome)|The retention rate was the proportion of participants who remained enrolled in the study and completed post-intervention measures. Range of retention rate is 0 to 1. Prostate cancer survivors were the population targeted in this intervention, therefore, the retention and attendance rates only include prostate cancer survivors (i.e., family members were not included in these calculations).|13-weeks||||proportion of participants|||Number
2662210|NCT01564394|Secondary|Brief Symptom Inventory (BSI)-18 Change From Baseline to 13-weeks|The BSI-18 assesses global distress and three subscales (anxiety, depression, & somatization). Scores are converted to T-scores based on US population norms. Negative change scores indicate improvement in distress. We report data separately for prostate cancer survivors and family members. Based on the population norm a T-score of 63 or above indicates heightened global distress.|Baseline to 13-weeks|Data is presented for Qigong participants (n=16) and family members (n=8 ) and for Stretching participants (n=13) and family members (n=7) .|||T-Score||Inter-Quartile Range|Median
2662211|NCT01564277|Secondary|Number of Patients Experiencing a Doubling of Serum Creatinine|Count of participants experiencing a doubling of serum creatinine|up to day 6|All treated and eligible patients|||Participants|||Count of Participants
2662212|NCT01564277|Secondary|Safety of Low Single-doses of Rasburicase.|The number of patients with any adverse events .|up to day 7|All treated and eligible patients|||Participants|||Count of Participants
2662213|NCT01564277|Secondary|Area Under the Plasma Uric Acid Concentration-time Curve (AUC) From Baseline (Day 1) to Day 7|The mean area under the plasma uric acid concentration-time curve (AUC) from baseline (Day 1) to Day 7|Up to day 7|All treated and eligible patients|||days*mg/dL||Standard Deviation|Mean
2662214|NCT01564277|Secondary|Baseline White Blood Cell Count by Response|The mean baseline white blood cell count of patients with a complete response (CR) (patients who achieved uric acid level =< 7.5mg/dL) and no CR (patients with uric acid level > 7.5mg/dL).|Up to day 7|All treated and eligible patients|||cells x 10^9/L||Standard Deviation|Mean
2662215|NCT01564277|Secondary|Number of Patients Requiring Additional Doses of Rasburicase to Maintain a Uric Acid Level =< 7.5mg/dL|Count of partcicpants requiring additional doses of rasburicase to maintain a uric acid level =< 7.5mg/dL by treatment arm.|Up to day 7|All treated and eligible patients|||Participants|||Count of Participants
2662216|NCT01564277|Primary|Probability of Obtaining a Uric Acid Level =< 7.5mg/dL|The proportion of patients able to achieve and/or maintain a uric acid level =< 7.5mg/dL for each treatment arm.|Within 24 hours of rasburicase treatment|All treated and eligible patients|||proportion of participants||95% Confidence Interval|Number
2662217|NCT01563978|Secondary|DAS28-CRP Improvement|ANCOVA=analysis of covariance, BID=twice daily, DAS28-CRP=Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (C-reactive protein [CRP]) and the patient's own assessment, FAS=full analysis set, IP=investigational product. Scores can take any positive value with a lower value indicative of a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicating a better clinical condition.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. The analysis population for each endpoint includes those patients from the FAS who were still on IP at 4 weeks and had a valid measurement for this type of assessment.|||Units on a scale||Standard Deviation|Mean
2662218|NCT01563978|Secondary|Mean Change From Completion/Discontinuation to Follow-up in Clinical Measurement of SBP and DBP|BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|Day 29 to Day 36|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. The analysis population for each endpoint includes patients from the FAS still on IP at Day 36 and with a valid measurement for this type of blood pressure assessment.|||mmHg||Standard Deviation|Mean
2662219|NCT01563978|Secondary|Mean Change From Baseline in Evening Post-dose Home SBP and DBP|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.|||mmHg||Standard Deviation|Mean
2662220|NCT01563978|Secondary|Mean Change From Baseline in Morning Pre-dose Home SBP and DBP|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.|||mmHg||Standard Deviation|Mean
2662221|NCT01563978|Secondary|Mean Change From Baseline in Clinic SBP and DBP|Blood pressure was measured in the clinic using an automated blood pressure machine (oscillometric method). Three separate measurements were taken 2 to 5 minutes apart and the mean of the 2nd and 3rd measurements calculated. ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.|||mmHg||Standard Deviation|Mean
2662222|NCT01563978|Secondary|Change From Baseline in Mean Sleeping SBP and DBP by Ambulatory Blood Pressure Monitoring|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.|||mmHg||Standard Deviation|Mean
2662223|NCT01563978|Secondary|Change From Baseline in Mean Awake SBP and DBP by Ambulatory Blood Pressure Monitoring|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.|||mmHg||Standard Deviation|Mean
2662224|NCT01563978|Secondary|Change From Baseline in Mean Daytime and Night-time SBP and DBP by Ambulatory Blood Pressure Monitoring|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.|||mmHg||Standard Deviation|Mean
2662225|NCT01563978|Secondary|Change From Baseline in 24-hour Mean Ambulatory DBP|ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and had a valid measurement for this type of blood pressure assessment.|||mmHg||Standard Deviation|Mean
2662226|NCT01563978|Primary|Change From Baseline in 24-hour Mean Ambulatory SBP|ANCOVA=analysis of covariance, BID=twice daily, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.|4 weeks|The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.|||mmHg||Standard Deviation|Mean
2662227|NCT01563913|Secondary|Forceplate Measured Dyskinesia|Dyskinesia are abnormal movements caused by levodopa. These abnormal movements will be measured with a forceplate (a device that is similar to a door mat). Dyskinesia will be examined at all inpatient visits and area under the curves will be compared with a clinical rating scale to measure the development of dyskinesia after starting levodopa therapy.|baseline and 1.5 years|Docosahexaenoic Acid Arm: 2 participants withdrew after the 6 week visit, 4 didn't complete visit 5 due to: wife's death, too busy, new diagnosis of cancer.|||Participants|||Count of Participants
2662228|NCT01563913|Primary|Efficacy of DHA - Number of Participants With An Abnormal Safety Lab (CBC)|This study is seeking to determine the safety/efficacy of DHA in Parkinson's disease patients. The safety/efficacy of DHA will be determined using periodic safety lab information. Safety labs for complete blood count (CBC) were performed at each inpatient visit, reviewed by the PI, and marked as normal or abnormal.|Year 1|3 participants did not complete year 1 visit (2 withdrew prior to year 1, 1 refused to travel for visit), 2 blood samples were hemolyzed and could not be analyzed.|||Participants|||Count of Participants
2662229|NCT01563913|Primary|Efficacy of DHA - Change in Blood ng/dL Levels|Therapeutic level monitoring will be accomplished by analyzing blood levels for DHA.|baseline and 1.5 years||||ng/dL - Blood||Standard Deviation|Mean
2662230|NCT01563536|Other Pre-specified|Resistance-Associated Variants and Phenotypic Resistance|Baseline (pre-dose on Day 1) samples were analyzed for resistance-associated amino acid (AA) variants using population sequencing. Phenotypic resistance to ABT-267 at Baseline was assessed by calculating the fold difference in the the half maximal effective concentration (EC50) compared with the EC50 for the appropriate reference replicon (1a-H77 or 1b-Con1). Day 3 samples were analyzed using population sequencing and were compared with the baseline and appropriate prototypic reference sequences to assess AA changes. Phenotypic resistance at Day 3 was assessed by calculating the fold difference in the EC50 compared with the EC50 for the corresponding Baseline sample. The number of participants with variants at resistance-associated AA positions and phenotypic resistance at Baseline and Day 3 are presented.|Day 1 Pre-dose (Baseline) and Day 3 Pre-dose|All participants who received at least one dose of study drug (ITT population) and had evaluable data were analyzed for baseline resistance-associated amino acid variants; the development of viral resistance was analyzed in all participants who received at least 1 dose of ABT-267 whose samples had sufficient viral titer to allow analysis.|||participants|||Number
2662231|NCT01563536|Primary|Mean Maximal Decrease From Baseline in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During ABT-267 Monotherapy|The baseline value was the last measurement before the first dose of ABT-267 monotherapy (Day 1). The maximal decrease during monotherapy was the change from baseline to the lowest log10 IU/mL HCV RNA level any time from the first dose of ABT-267 on Day 1 to the last log10 HCV RNA level before the first dose of ABT-267 combination therapy (Study Day 3).|Pre-dose on Days 1, 2, and 3|All participants who received at least one dose of study drug (ITT population).|||log10 IU/mL||Standard Error|Least Squares Mean
2662232|NCT01563536|Secondary|Mean Change in Viral Load From Baseline to Pre-dose on Day 2 and Day 3 of ABT-267 Monotherapy|The relationship between ABT-267 dose, ABT-267 concentration, and response was analyzed as the change in viral load (measured as log10 IU/mL) from baseline (pre-dose on Day 1) to pre-dose on Days 2 and 3. Plasma concentrations of ABT-267 pre-dose on Days 2 and 3 are presented above in 4. Primary Outcome: Plasma Concentration of ABT-267 Pre-dose (Ctrough) on Day 2 and Day 3.|Predose on Days 1, 2, and 3|All participants who received at least one dose of study drug (ITT population).|||log10 IU/mL||Standard Deviation|Mean
2662233|NCT01563536|Secondary|Percentage of Participants With Extended Rapid Virologic Response|The percentage of participants with virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) at Weeks 4 through 12 of combination therapy.|Weeks 4 to 12|All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
2662234|NCT01563536|Secondary|Percentage of Participants With End-of-Treatment Response|The percentage of participants with virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) at the end of combination therapy (12 weeks).|12 weeks|All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
2662235|NCT01563536|Secondary|Percentage of Participants With Rapid Virologic Response|The percentage of participants with virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) after 4 weeks of combination therapy.|4 weeks|All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
2662236|NCT01563536|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks and 24 Weeks After Combination Therapy|The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 and 24 weeks after the last dose of combination study drug. The LLOQ for the assay was 25 IU/mL.|12 and 24 weeks after last dose of combination study drug|All participants who received at least one dose of study drug (ITT population); participants with missing data were counted as non-responders.|||percentage of participants|||Number
2662237|NCT01563536|Primary|Number of Participants With Adverse Events (AEs)|"An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.~The investigator assessed the relationship of each AE to the use of direct-acting antiviral agents (DAAs), and rated the severity of each event as either: Mild: The AE was transient and easily tolerated by the participant; Moderate: The AE caused the participant discomfort and interrupted usual activities; Severe: The AE caused considerable interference with the participant's usual activities and could have been incapacitating or life-threatening.~A serious adverse event was any event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in a congenital anomaly or persistent or significant disability or was any other important medical event requiring medical or surgical intervention."|All AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks).|All participants who received at least one dose of study drug (safety population).|||participants|||Number
2662238|NCT01563536|Primary|Plasma Concentration of ABT-267 Pre-dose (Ctrough) on Day 2 and Day 3|Blood samples were collected pre-dose on Day 2 (prior to second dose of ABT-267 monotherapy) and pre-dose on Day 3 (prior to first dose of combination therapy). The samples were analyzed for ABT-267 using validated analytical methods. Pre-dose plasma concentrations on Day 2 and Day 3 (Ctrough, measured in ng/mL) are reported.|Day 2 (pre-dose) and Day 3 (pre-dose)|All participants who received at least one dose of study drug (ITT population).|||ng/mL||Standard Deviation|Mean
2662239|NCT01563536|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[24]) of ABT-267 Following Monotherapy on Day 1|Blood samples were collected pre-dose (time 0) and at 2, 4, and 6 hours post-dose on Day 1 and pre-dose on Day 2 (ABT-267 monotherapy). The samples were analyzed for ABT-267 using validated analytical methods. Area under the plasma concentration-time curve from time 0 to 24 hours (AUC[24]; measured in ng multiplied by hour/mL) was estimated using noncompartmental analyses.|Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose)|All participants who received at least one dose of study drug (ITT population).|||ng*hr/mL||Standard Deviation|Mean
2662240|NCT01563536|Primary|Time of Maximum Plasma Concentration (Tmax) of ABT-267 Following Monotherapy on Day 1|Blood samples were collected pre-dose (time 0) and at 2, 4, and 6 hours post-dose on Day 1 and pre-dose on Day 2 (ABT-267 monotherapy). The samples were analyzed for ABT-267 using validated analytical methods. Time of maximum plasma concentration (Tmax; measured in hours) was estimated using noncompartmental analyses.|Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose)|All participants who received at least one dose of study drug (ITT population).|||hours||Standard Deviation|Mean
2662241|NCT01563536|Primary|Maximum Plasma Concentration (Cmax) of ABT-267 Following Monotherapy on Day 1|Blood samples were collected pre-dose (time 0) and at 2, 4, and 6 hours post-dose on Day 1 and pre-dose on Day 2 (ABT-267 monotherapy). The samples were analyzed for ABT-267 using validated analytical methods. Maximum plasma concentration (Cmax; measured in ng/mL) was estimated using noncompartmental analyses.|Day 1 (pre-dose [time 0] and at 2, 4, and 6 hours post-dose) and Day 2 (pre-dose)|All participants who received at least one dose of study drug (intent-to-treat [ITT] population).|||ng/mL||Standard Deviation|Mean
2662242|NCT01563406|Secondary|Median Number of Microbial Colony Forming Units Per Hub Interior|This will be a quantitative outcome. It will be reported as the median number of microbial colony forming units isolated per hub interior. The median number of microbial colony forming units isolated per hub interior will be compared for the four study arms.|15 months||||colony forming units (CFU) per hub|Participants|Inter-Quartile Range|Median
2662243|NCT01563406|Secondary|Number of Contaminated Central Venous Catheter Tips|"This will be a qualitative measure for central venous catheter tip contamination. The results will be reported as yes or no."|10 months|Unable to collect a sufficient number of catheter tips to analyze. Therefore, this outcome was dropped early in the study.||||||
2662244|NCT01563406|Primary|Number of Central Venous Catheter Hubs With Internal Contamination|"This will be a qualitative outcome. It will be reported as yes or no for central venous catheter hub internal contamination. The number of hubs with internal contamination will be compared for the four study arms."|15 months|140 participants were recruited through 149 separate medical intensive care unit (MICU) admissions. Each MICU admission is treated as a separate enrollment.|||contaminated hubs|Participants||Number
2662245|NCT01563198|Secondary|Change in No-Show Rates of Patients From the Average of the Baseline Year to the Average of One Year Post Training|The sites will be followed for an average of one year after training in Comfort Talk and no-show rates will be compared to the baseline values of non-completion among all scheduled patients which were also collected over 1 year.|Baseline average of one year plus post training average one year = 2 years|Participants were from MRI 3 sites whose teams were trained in Comfort Talk®. In this analysis all patients who were scheduled for scans during the baseline year and the year after training were included.|||Percentage of participants|||Number
2662246|NCT01563198|Primary|Change in Non-completion Rate of MRI Scans From the Average of the Baseline Year to the Average of One Year Post Training (Showing-Up Patients Only)|The change in non-completion rate of MRI scans, obtained for the year prior to Comfort Talk® training at baseline, to the average one year post training was assessed|Baseline average of one year plus post training average one year = 2 years|Participants were from 3 MRI sites whose teams were trained in Comfort Talk®. In this analysis only patients who showed up at the MRI sites at baseline year and the year after training were included (all participants minus no-shows).|||Percentage of showing-up participants|||Number
2662247|NCT01563198|Primary|Change in Non-completion Rate of MRI Scans From the Average of the Baseline Year to the Average of One Year Post Training (All Scheduled Patients)|The sites will be followed for an average of one year after training in Comfort Talk and non-completion rates will be compared to the baseline values of non-completion among all scheduled patients.|Baseline average of one year plus post training average one year = 2 years|Participants were from MRI 3 sites whose teams were trained in Comfort Talk®. In this analysis all patients who were scheduled for scans during the baseline year and the year after training were included|||Percentage of participants|||Number
2662248|NCT01563185|Secondary|Multiple Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Volume Distribution (V/F)|V/F were estimated in ibuprofen and famotidine.|Pre-dose and 0.5, 1, 2, 4, and 8 hours post-dose in the single dose group; sparse samples at random times in the multiple dose group||||L/70 kg||Standard Deviation|Mean
2662249|NCT01563185|Secondary|Multiple Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Individual Oral Clearance (CL/F)|CL/F was estimated in ibuprofen and famotidine.|Pre-dose and 0.5, 1, 2, 4, and 8 hours post-dose in the single dose group; sparse samples at random times in the multiple dose group|The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 of the patients was not evaluable and all 9 were in the multiple dose pharmacokinetic group).|||L/h/70 kg||Standard Deviation|Mean
2662250|NCT01563185|Secondary|Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Area Under the Concentration-time Curve From the Time of Dosing to the Last Measurable Concentration (AUC(0-t))|AUC(0-t) was estimated for ibuprofen and famotidine. The PK parameters for ibuprofen and famotidine represent average AUC values following a single oral dose of DUEXIS. Samples were collected pre-dose and at 0.5, 1, 2, 4, and 8 to 10 hours following study drug administration.|Pre-dose, and 0.5, 1, 2, 4, 8 hours post-dose|The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 patient was not evaluable, and all 9 were in the multiple dose pharmacokinetic group).|||ug*h/mL||Standard Deviation|Mean
2662251|NCT01563185|Secondary|Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Maximum Observed Concentration (Cmax)|Cmax was estimated for ibuprofen and famotidine. The PK parameters for ibuprofen and famotidine represent average Cmax values following a single oral dose of DUEXIS. Samples were collected pre-dose and at 0.5, 1, 2, 4, and 8 to 10 hours following study drug administration.|Pre-dose, and 0.5, 1, 2, 4, 8 hours post-dose|The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 of the patients was not evaluable, and all 9 were in the multiple dose pharmacokinetic group).|||ug/mL||Standard Deviation|Mean
2662252|NCT01563185|Secondary|Single Dose Pharmacokinetic Characteristics of DUEXIS in JIA Patients: Time of Maximum Observed Concentration (Tmax)|Tmax was estimated for ibuprofen and famotidine.The PK parameters for ibuprofen and famotidine represent average Tmax values following a single oral dose of DUEXIS. Samples were collected pre-dose and at 0.5, 1, 2, 4, and 8 to 10 hours following study drug administration.|Pre-dose, 0.5, 1, 2, 4, 8 hours post-dose|The initial 9 patients met the PK objective of the study (4 were in the single dose pharmacokinietic group, however, 1 of the patients was not evaluable, and all 9 were in the multiple dose pharmacokinetic group).|||hours||Standard Deviation|Mean
2662253|NCT01563185|Secondary|American College of Rheumatology (ACR) Pediatric Core Measures: Serum C Reactive Protein (CRP) Concentration|The following ACR pediatric Core Measure of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: CRP Concentration. This ACR value represents the average change in Serum C Reactive Protein (CRP) Concentration from the baseline visit to the week 24/ET visit. The normal range referenced was 0 mg/L - 4.99 mg/L.|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).||||mg/L||Standard Error|Mean
2662254|NCT01563185|Secondary|ACR Pediatric Components by Time Point: Number of Joints With Active Arthritis and the Number of Joints With Limited Range of Motion Number of Joints With Active Arthritis|"The following 2 ACR pediatric Core Measures of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: number of joints with active arthritis and the number of joints with limited range of motion. These ACR values represent the average change in number of joints with active arthritis and the number of joints with limited range of motion from the baseline visit to the week 24/ET visit.~The joints that were assessed include the right and left temporomandibular, sternoclavicular, arcomiclavicular, shoulder, elbow, wrist, MCP - 1. MCP - 2, MCP - 3, MCP - 4, MCP - 5, PIP - 1, PIP - 2, PIP - 3, PIP - 4, PIP - 5, DIP - 1, DIP - 2, DIP - 3, DIP - 4, and DIP - 5."|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).||||Number of joints||Standard Error|Mean
2662255|NCT01563185|Secondary|American College of Rheumatology (ACR) Pediatric Core Measures: CHAQ - Disability Index|The following ACR pediatric Core Measure of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: CHAQ - Disability Index. This ACR measurement represents the average change in the Childhood Health Assessment Questionnaire (CHAQ) - Disability Index from the baseline visit to the week 24/ET visit. The CHAQ disability index is measured on a scale of 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do).|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).||||units on a scale||Standard Error|Mean
2662256|NCT01563185|Secondary|American College of Rheumatology (ACR) Pediatric Core Measures: Physician's Global Assessment of Disease Activity and Parent's Assessment of Overall Well-being|The following 2 ACR pediatric Core Measures of JIA activity and the parent's assessment of discomfort were quantitatively assessed at baseline and each study visit: the physician's global assessment of disease activity and the parent's global assessment of overall well-being. These ACR values represent the average change in the physician's global assessment of disease activity and the parent's global assessment of overall well-being from the baseline visit to the week 24/ET visit. The ACR pediatric core measure: Physician's global assessment of disease activity and parent's assessment of overall well being was measured on a scale of 0-100 mm (0 = very good, 100=very poor).|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).||||units on a scale||Standard Error|Mean
2662257|NCT01563185|Secondary|Childhood Health Questionnaire Parent Form 50 (CHQ-PF50) Scores|"To assess patient quality of life while on study medication, the CHQ was administered to the patients' parent or guardian on Day 0 and at the Week 24/ET visit. The raw scale scores were transformed into scores on a 0 to 100 scale, 100 indicating best health and 0 indicating worst health. The algorithm is:~Transformed Score = ((Actual Raw Score - Lowest Possible Raw Score)/(Possible Raw Score Range)) x100. The actual raw score is the mean of the item responses in a scale (sum of item responses/number of completed items). The possible raw score range is the highest possible raw score minus the lowest possible raw score. The outcome measure data table shows the average change in the CHQ concepts from Baseline to the week 24 visit. The average change in the CHQ concepts is on a -100 to 100 scale, -100 representing a negative change in health and 100 indicating a positive change in health."|Baseline to Endpoint (Endpoint is the last post-baseline value obtained, as two subjects did not complete the study up until week 24).||||units on a scale||Standard Deviation|Mean
2662258|NCT01563185|Primary|Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs)|Safety assessments included AE monitoring, concomitant medication review, physical examinations (including vital signs and weight), and clinical laboratory assessments, including pregnancy testing for female patients. The outcome measure data table below describes the TEAEs experienced by patients.|Day 0 through Week 26/ET (adverse event data was collected at every visit, including telephone visits)||||participants|||Number
2662259|NCT01563172|Secondary|Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Control Dentifrice.|EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.|At Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||μg×F/cm2||Standard Error|Least Squares Mean
2662260|NCT01563172|Secondary|Enamel Fluoride Uptake (EFU) After Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.|EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.|At Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||μg×F/cm2||Standard Error|Least Squares Mean
2662261|NCT01563172|Secondary|Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.|EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.|At Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||μg×F/cm2||Standard Error|Least Squares Mean
2662262|NCT01563172|Secondary|Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.|EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.|At Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||μg×F/cm2||Standard Error|Least Squares Mean
2662263|NCT01563172|Secondary|Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.|EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.|At Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||micrograms (μg)×F/centimeters(cm)2||Standard Error|Least Squares Mean
2662264|NCT01563172|Secondary|Percent Surface Micro-hardness (% SMH) Recovery, of Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of an Control Dentifrice.|SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.|At Baseline and at Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||% SMH||Standard Error|Least Squares Mean
2662265|NCT01563172|Secondary|Percentage Surface Micro-hardness Recovery (% SMH), of Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.|SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.|At Baseline and at Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||% SMH||Standard Error|Least Squares Mean
2662266|NCT01563172|Secondary|Percentage Surface Micro Hardness (% SMH) Recovery, of Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.|SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.|At Baseline and at Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||% SMH||Standard Error|Least Squares Mean
2662267|NCT01563172|Secondary|Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.|SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.|At Baseline and at Day 14|PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||% SMH||Standard Error|Least Squares Mean
2662268|NCT01563172|Primary|Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.|SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer [μm]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): [D1-R/D1-B] ×100.|At Baseline and at Day 14|Per Protocol (PP) population: Included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.|||% SMH||Standard Error|Least Squares Mean
2662269|NCT01563081|Secondary|Cmax and Cmin of Levocetirizine in Plasma|Cmax is defined as the peak plasma concentration of a drug after administration. Cmin is defined as the lowest (trough) concentration that a drug reaches before the next dose is administered. For both age cohorts, blood samples were collected 1.5-2.5 hours after the last drug administration for assessment of Cmax at either Week 1 or 2/EW. For participants in the >=6 months and <12 months cohort, blood samples were collected 22.5-25.5 hours after the last drug administration for Cmin at a different visit from Cmax sampling. For participants in the >=12 months and <24 months cohort, blood samples were collected 10.5-13.5 hours after the final drug administration for Cmin at a different visit from Cmax sampling. For all participants, if Cmin sampling occurred at Week 1, then Cmax sampling occurred at Week 2/EW, and vice versa.|Weeks 1 and 2/Early Withdrawal|Pharmacokinetic Concentration Population: all participants who underwent blood sampling, who provided data at the time of the last dose and the time of blood sampling, and who provided valid drug concentrations|||nanograms per milliliter||Full Range|Median
2662270|NCT01563081|Secondary|Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal|The investigator comprehensively assessed the pariticipant's severity of pruritus on the first day of treatment (FDOT), at Week 1, and at Week 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) by using the following scale: 4, severe; 3, moderate; 2, mild; 1, slight; 0, none.|First day of treatment; Weeks 1 and 2/Early Withdrawal|FAS. Only those participants with pruritis associated with skin diseases at Baseline were assessed for pruritis severity.|||participants|||Number
2662271|NCT01563081|Secondary|Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator|The investigator or sub-investigator comprehensively assessed the participants' improvement in nasal symptoms (allergic rhinitis [AR]) and pruritus associated with skin diseases (PAWSD) at Weeks 1 and 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) compared to the first day of treatment by using the following scale: 1, markedly improved; 2, moderately improved; 3, slightly improved; 4, no change; 5, worsened.|First day of treatment; Weeks 1 and 2/Early Withdrawal|"FAS. Only those participants with AR and PAWSD at Baseline were assessed for improvement in the conditions at Weeks 1 and 2/Early Withdrawal. The ns in the category titles reflect the number of participants in the Full Analysis Set (FAS) who had AR and PAWSD at Baseline."|||participants|||Number
2662272|NCT01563081|Secondary|Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression|"The investigator or sub-investigator made an overall assessment of nasal symptoms (allergic rhinitis [AR]) and pruritus associated with skin diseases (PAWSD) at Weeks 1 and 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) by asking the participants' legal representatives to provide feedback using the following scale: 1, significantly improved; 2, moderately improved; 3, mildly improved; 4, no change; 5, mildly worse; 6, moderately worse; 7, significantly worse. Only those participants with AR and PAWSD at Baseline were assessed for improvement in the conditions at Weeks 1 and 2. The ns in the category titles reflect the number of participants in the Full Analysis Set (FAS) who had AR and PAWSD at Baseline."|First day of treatment; Weeks 1 and 2/Early Withdrawal|Full Analysis Set (FAS): all participants, excluding those with any major good clinical practice deviation, those who did not meet the primary criteria for enrollment, those who received no dose of study medication, and those with no data after supply of the investigational product|||participants|||Number
2662273|NCT01563081|Primary|Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs)|A non-serious AE is defined as any untoward medical occurrence in a participant/clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is a possible drug-induced liver injury. For a list of all SAEs/non-serious AEs occurring at a frequency of >=5%, please see the SAE/non-serious AE module of this record.|up to Week 2/Early Withdrawal (EW)|Safety Population : all participants who participated in this study and who received at least one dose of medication|||participants|||Number
2662274|NCT01563055|Secondary|AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D and AUC (0-tau)/D of Phenyl Acetic Acid Mustard|Dose adjusted AUC for the indicated time points were assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hr*ng/mL/mg||95% Confidence Interval|Geometric Mean
2662275|NCT01563055|Secondary|AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D, and AUC (0-tau)/D of Chlorambucil|Dose adjusted AUC for the indicated time points were assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hr*ng/mL/mg||95% Confidence Interval|Geometric Mean
2662276|NCT01563055|Secondary|Cmax/D for Phenyl Acetic Acid Mustard|Cmax/D is defined as the maximum plasma concentration (Cmax) per unit dose. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||ng/mL/mg||95% Confidence Interval|Geometric Mean
2662277|NCT01563055|Secondary|Dose Normalized Cmax (Cmax/D) for Chlorambucil|Cmax/D is defined as the maximum plasma concentration (Cmax) per unit dose. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4 and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||ng/mL/mg||95% Confidence Interval|Geometric Mean
2662278|NCT01563055|Secondary|AUC (0-t) of Phenyl Acetic Acid Mustard|AUC (0-t) represents the area under the concentration curve of phenyl acetic acid mustard in serum from 0 to time t hours. AUC (0-t) was assessed at 6 hours and 24 hours.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hr*ng/mL||95% Confidence Interval|Geometric Mean
2662279|NCT01563055|Secondary|AUC (0-t) of Chlorambucil|AUC (0-t) represents the area under the concentration curve of chlorambucil in serum from 0 to time t hours. AUC (0-t) was assessed at 6 hours and 24 hours.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hr*ng/mL||95% Confidence Interval|Geometric Mean
2662280|NCT01563055|Secondary|AUC (0-t) of Ofatumumab|AUC (0-t) represents the area under the concentration curve of ofatumumab in plasma from 0 to time t hours. AUC (0-t) was assessed at 168 hours and 672 hours post-dose.|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hr*µg/mL||95% Confidence Interval|Geometric Mean
2662281|NCT01563055|Secondary|%AUC_extrap of Phenyl Acetic Acid Mustard|%AUC_extrap is defined as the area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||percentage of AUC after extrapolation||95% Confidence Interval|Geometric Mean
2662293|NCT01563055|Secondary|Plasma Half-life (t1/2) of Phenyl Acetic Acid Mustard|t1/2 is the time required for the plasma/serum concentration of phenylacetic acid mustard to decrease by half. Blood samples for serum concentration of phenylacetic acid mustard was collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population|||hours||95% Confidence Interval|Geometric Mean
2662282|NCT01563055|Secondary|%AUC_extrap of Chlorambucil|%AUC_extrap is defined as the area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||percentage of AUC after extrapolation||95% Confidence Interval|Geometric Mean
2662283|NCT01563055|Secondary|%AUC_extrap of Ofatumumab|%AUC_extrap is defined as the area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population|||percentage of AUC after extrapolation||95% Confidence Interval|Geometric Mean
2662284|NCT01563055|Secondary|Apparent Volume of Distribution During Terminal Phase (Vz/F) of Chlorambucil|Vz/F of chlorambucil is defined as the apparent volume of distribution during terminal phase after non-intravenous (oral) administration of chlorambucil. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||L/m^2||95% Confidence Interval|Geometric Mean
2662285|NCT01563055|Secondary|Apparent Total Clearance of the Drug From Plasma (CL/F) for Chlorambucil|CL/F is defined as the apparent total clearance of the drug from plasma after oral administration of chlorambucil. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||L/hr/m^2||95% Confidence Interval|Geometric Mean
2662286|NCT01563055|Secondary|Volume of Distribution (Vz) of Ofatumumab|Vz for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body during the terminal phase to the plasma concentration during the terminal phase. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population|||mL||95% Confidence Interval|Geometric Mean
2662287|NCT01563055|Secondary|Mean Residence Time Inf (MRTinf) of Phenyl Acetic Acid Mustard|MRTinf is the average amount of time that phenyl acetic acid mustard spends in the body. Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hours||95% Confidence Interval|Geometric Mean
2662288|NCT01563055|Secondary|Mean Residence Time Inf (MRTinf) of Chlorambucil|MRTinf is the average amount of time that chlorambucil spends in the body. Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hours||95% Confidence Interval|Geometric Mean
2662289|NCT01563055|Secondary|Mean Residence Time to Infinity (MRTinf) of Ofatumumab|MRTinf is the average amount of time that ofatumumab spends in the body. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population|||hours||95% Confidence Interval|Geometric Mean
2662290|NCT01563055|Secondary|Time to Maximum Concentration (Tmax) of Phenyl Acetic Acid Mustard|Tmax is the time required for reaching maximum concentration of drug (Cmax). Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hours||Full Range|Median
2662291|NCT01563055|Secondary|Time to Maximum Concentration (Tmax) of Chlorambucil|Tmax is the time required for reaching maximum concentration of drug (Cmax). Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hours||Full Range|Median
2662292|NCT01563055|Secondary|Time to Maximum Concentration (Tmax) of Ofatumumab|Tmax is the time required for reaching maximum concentration of drug (Cmax). Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr) and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hours||Full Range|Median
2662294|NCT01563055|Secondary|Plasma Half-life (t1/2) of Chlorambucil|t1/2 is the time required for the serum concentration of chlorambucil to decrease by half. Blood samples for serum concentration of chlorambucil was collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hours||95% Confidence Interval|Geometric Mean
2662295|NCT01563055|Secondary|Plasma Half-life (t1/2) of Ofatumumab|t1/2 is the time required for the plasma concentration of ofatumumab to decrease by half. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr) and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||hours||95% Confidence Interval|Geometric Mean
2662296|NCT01563055|Secondary|Volume of Distribution at Steady State (Vss) of Ofatumumab|Volume of distribution at steady state (Vss) is defined as the distribution of a drug between plasma and the rest of the body at steady state. Samples were collected at Cycle 1-Day1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population|||mL||95% Confidence Interval|Geometric Mean
2662297|NCT01563055|Secondary|AUC(0-infinity) for Phenyl Acetic Acid Mustard|The total AUC or AUC(0-infinity) is the area under the curve from time 0 extrapolated to infinite time. It was assesed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hr*ng/mL||95% Confidence Interval|Geometric Mean
2662298|NCT01563055|Secondary|AUC(0-infinity) for Chlorambucil|The total AUC or AUC0-infinity is the area under the curve from time 0 extrapolated to infinite time. It was assesed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hr*ng/mL||95% Confidence Interval|Geometric Mean
2662299|NCT01563055|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab|The total AUC or AUC0-infinity is the area under the curve from time 0 extrapolated to infinite time. It was assesed on Cycle 1-Day 1. The samples were collected at Cycle 1-Day1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population|||Hr*ug/mL||95% Confidence Interval|Geometric Mean
2662300|NCT01563055|Secondary|AUC(0-tau) of Phenyl Acetic Acid Mustard|Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the drug plasma/serum concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of the drug. It was assesed at 1st (Cycle 1-Day 1), 4th (Cycle 1-Day 4), and 15th (Cycle 3-Day 57) chlorambucil administration. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hr*ng/mL||95% Confidence Interval|Geometric Mean
2662301|NCT01563055|Secondary|AUC(0-tau) of Chlorambucil|Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the drug plasma/serum concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of the drug. It was assesed at 1st (Cycle 1-Day 1), 4th (Cycle 1-Day 4), and 15th (Cycle 3-Day 57) chlorambucil administration. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hr*ng/mL||95% Confidence Interval|Geometric Mean
2662302|NCT01563055|Secondary|Area Under the Drug Plasma Concentration-time Curve From Dosing to Time Tau (AUC[0-tau]) of Ofatumumab|Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the drug plasma/serum concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of the drug. For ofatumumab it was assesed at Cycle 1-Day 1 and Cycle 3-Day 57. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr) and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Hours*nanogram/milliliter (hr*ng/mL||95% Confidence Interval|Geometric Mean
2662303|NCT01563055|Secondary|Total Plasma Clearance (CL) of Ofatumumab|Plasma clearance is defined as the plasma volume which is totally cleared of drug per unit of time. Blood samples were collected at Cycle 1-Day1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr).|Cycle 1-Day 1|PK Population|||Milliliters/hour (mL/hr)||95% Confidence Interval|Geometric Mean
2662304|NCT01563055|Secondary|Cmin of Phenyl Acetic Acid Mustard|Cmin of chlorambucil metabolite phenyl acetic acid mustard was assesed at Cycle 1-Day 4 and Cycle 3-Day 57. Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 4 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||ng/mL||95% Confidence Interval|Geometric Mean
2662305|NCT01563055|Secondary|Cmin of Chlorambucil|Cmin of chlorambucil was assesed at Cycle 1-Day 4 and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 4 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||ng/mL||95% Confidence Interval|Mean
2662306|NCT01563055|Secondary|Minimum Plasma Concentration (Cmin) of Ofatumumab|Minimum plasma drug concentration of ofatumumab was determined at Cycle 1-Day 8, Cycle 2-Day 29, Cycle 3-Day 57, Cycle 4-Day 85, Cycle 5-Day 113, and Cycle 6-Day 141. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr), Cycle 2-Day 29 (pre-dose), Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr), Cycle 4-Day 85 (pre-dose, 30 min post end of infusion), Cycle 5-Day 113 (pre-dose and end of infusion) and Cycle 6-Day 141 (pre-dose and end of infusion).|Cycle 1-Day 8, Cycle 2-Day 29, Cycle 3-Day 57, Cycle 4-Day 85, Cycle 5-Day 113, and Cycle 6-Day 141|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Micrograms/milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2662307|NCT01563055|Secondary|Cmax of Serum Phenyl Acetic Acid Mustard|Cmax of chlorambucil metabolite phenyl acetic acid mustard was assesed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||ng/mL||95% Confidence Interval|Geometric Mean
2662308|NCT01563055|Secondary|Cmax of Serum Chlorambucil|Cmax of serum chlorambucil was assesed at Cycle 1-Day 1, Cycle 1-Day 4 and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr.|Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||ng/mL||95% Confidence Interval|Geometric Mean
2662309|NCT01563055|Secondary|Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab|Maximum (peak) plasma drug concentration of ofatumumab was determined at Cycle 1-Day 1 and Cycle 3-Day 57. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr), and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr).|Cycle 1-Day 1 and Cycle 3-Day 57|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population.|||Micrograms/milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2662310|NCT01563055|Secondary|Complement (CH50) at Cycle 1-Day 1 and Cycle 4-Day 85|The CH50 is the serum complement to lyse 50% of sensitized red blood cells; it is a marker of complement activation. A high CH50 level suggests evidence for complement activation, whereas a low CH50 level suggests lack of complement activation. Peripheral blood samples were collected for analysis at Cycle 1-Day 1 and Cycle 4-Day 85.|Cycle 1-Day 1 and Cycle 4-Day 85|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects pPopulation.|||Kilo units per liter (KU/L)||Standard Deviation|Mean
2662311|NCT01563055|Secondary|Beta-2 Microglobulin at Cycle 1-Day 1|Beta-2-microglobulin is a protein present on the surface of most cells. Higher levels indicate a poor prognosis of CLL. Beta-2 microglobulin was measured at Cycle 1-Day 1.|Cycle 1-Day 1|All Subjects Population|||Nanomoles per liter (NMOL/L)||Standard Deviation|Mean
2662312|NCT01563055|Secondary|Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points|CD5+CD19+ cells were counted in peripheral blood by flow cytometry. Baseline CD5+CD19+ and CD5-CD19+ cell count value is the last pre-dose assessment values performed on Cycle 1-Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. B-cell monitoring (CD5+CD19+ and CD5-CD19+) was performed at Cycle 1 (Day 1, Day 15) and Cycle 2 (Day 29, Day 43), on Day 1 of Cycle 3, 4, 5, 6, 9 and 12 (Day 57, Day 85, Day 113, Day 141, Day 225, Day 309), 28 days after the first day of the last treatment cycle (FU 1-PDFU 1) for all participants depending on the number of cycles administered, and 84 and 168 days after the day of FU 1-PDFU 1 for participants in CR, PR, and SD.|Baseline, C1-D15, C2-D29, C2-D43, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9-D225, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), FU 85-PDFU 85 (84 days after FU-1), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects population.|||Cells per microliter||Standard Deviation|Mean
2662329|NCT01563029|Secondary|Number of Withdrawals Due to Lack of Efficacy Throughout the 12-week Treatment Period|The number of participants whose primary reason for withdrawal from the study was due to lack of efficacy is presented together with p-values for the treatment comparisons.|Up to Week 12|ITT Population|||Participants|||Number
2662313|NCT01563055|Secondary|Number of Participants Who Were Positive or Negative for Minimal Residual Disease (MRD), as Assessed by IRC With CT|MRD refers to small number of leukemic cells that remain in the participant's body during treatment or after treatment in participants who achieved a confirmed complete remission. MRD assessment in bone marrow aspiration sample was perfrmed by flow cytometry (cluster of differentiation [CD]5, CD19, CD20, CD23). The absence of MRD was defined as less than one CLL cell per 10,000 leukocytes. The number of participants who were positive and negative for MRD are presented.|FU 85-PDFU 85 (84 days after FU-1)|All Subjects Population. Only those participants who were positive and negative for MRD were analyzed.|||Participants|||Number
2662314|NCT01563055|Secondary|Mean Change From Baseline in the Immunoglobulins (Ig) Antibodies IgA, IgG, and IgM at the Indicated Time Points|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1-Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Immunoglobulins were measured at Cycle 1-Day 1, FU 1-PDFU 1, and FU 169-PDFU 169 for participants in CR, PR, and stable disease (SD).|Baseline (Cycle 1-Day 1), FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects population.|||Grams per liter||Standard Deviation|Mean
2662315|NCT01563055|Secondary|Number of Participants With the Indicated Results for Human Anti-human Antibody (HAHA) at the Indicated Time Points|HAHA are indicators of immunogenicity induced by ofatumumab. Blood samples were taken from participants at Screening, Cycle 4-Day 85, FU 1-PDFU 1, and FU 169-PDFU 169. The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. The results are presented as participants with HAHA results as positive, negative or confirmation required.|Screening, Cycle 4-Day 85, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Participants|||Number
2662316|NCT01563055|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events|"Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.03 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death). AEs not in the list of CTCAE were graded at discretion of the investigator. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. Participants with Grade (G)3 or G4 adverse event of infection and myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Also presented are number of participants with autoimmune hemolytic anemia (AIHA). AIHA is a disease where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells."|From start of treatment until follow-up for survival (up to Week 62.3)|All Subjects Population|||Participants|||Number
2662317|NCT01563055|Secondary|Number of Participants With AEs of Maximum Severity|Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.03 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death). AEs not in the list of CTCAE were graded at discretion of the investigator.|From start of treatment until follow-up for survival (up to Week 62.3)|All Subjects Population|||Participants|||Number
2662318|NCT01563055|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed.|From start of treatment until follow-up for survival (up to Week 62.3)|All Subjects Population|||Participants|||Number
2662319|NCT01563055|Secondary|Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|ECOG PS is a scale to assess disease progression, extent to which disease affects the daily living abilities and determines appropriate treatment and prognosis. It is scored on a scale of 0 to 5 as, 0 (fully active), 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2 (ambulatory and capable of all self cares but unable to carry out any work activities, up and about > 50% of waking hours), 3 (capable of only limited self cares, confined to bed or chair > 50% of waking hours), 4 (completely disabled, cannot carry on any self cares, totally confined to bed or chair), 5 (death). Improvement is defined as decrease from Baseline by at least one step on the ECOG performance status scale (yes/no). Baseline was the last pre-dose assessment performed on Cycle 1-Day 1(C1-D1). When C1-D1 was missing, the last assessment performed prior to pre-dose C1-D1 was used. It was performed on Day 1 of each cycle and follow-up (FU).|Baseline, C2-D29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9 -D225, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), FU 85-PDFU 85 (84 days after FU-1), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects population.|||Participants|||Number
2662351|NCT01562782|Secondary|Peak Gastric Inhibitory Protein (GIP) Levels in the 2 Study Groups|A comparison of the mean peak gastric inhibitory protein (GIP) at 2 hours in each group. GIP is expected to increase after ingestion of glucose/fructose.|2 hours||||ng/L||Standard Deviation|Mean
2662352|NCT01562782|Secondary|Peak Insulin Levels in 2 Study Groups|A comparison of the mean peak insulin level at one hour in each group. Insulin is expected to increase after ingestion of glucose/fructose.|1 hour||||IU/L||Standard Deviation|Mean
2662320|NCT01563055|Secondary|Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points|The number of participants with no B-symptoms (no night sweat [without signs of infection], no unexplained, unintentional weight loss >= 10% within the previous 6 months, no recurrent, unexplained fever of greater than 38 degrees celcius for 2 weeks and no extreme fatigue) and the number of participants with at least one of the B-symptoms are summarized by assessment time. The presence of the B-symptoms was assessed at Baseline, Day 1 of each treatment cycle and follow-up (FU). Baseline was the last pre-dose assessment performed at Cycle (C) 1-Day (D) 1.|Baseline, C2-D29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9 -D225, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), FU 85-PDFU 85 (84 days after FU-1), and FU 169-PDFU 169 (168 days after FU-1)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Participants|||Number
2662321|NCT01563055|Secondary|Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy|Time to next CLL therapy is defined as the time from start of treatment until the first administration of the next CLL treatment other than chlorambucil administrations scheduled in this study. Time to next CLL therapy was restricted to the subgroup of the population who receive a next CLL therapy after experiencing disease progression.|From start of treatment until the first administration of the next CLL therapy (up to Week 62.3)|All Subjects Population. Only those participants who received next CLL therapy were evaluated.|||Weeks||95% Confidence Interval|Median
2662322|NCT01563055|Secondary|Duration of Response, as Assessed by the IRC|Duration of response is defined as the time from the first documented evidence of CR, CRi, nPR or PR until the first documented sign of PD or death in participants with CR, CRi, nPR or PR. For participants who did not progress or die, duration of response was censored on the date of last assessment.|From initial response (CR/CRi/nPR/PR) until disease progression or death (up to Week 62.3)|All Subjects Population. Only those participants classified as responders (CR, CRi, PR, nPR) were evaluated.|||Weeks||95% Confidence Interval|Median
2662323|NCT01563055|Secondary|Time to Response, as Assessed by the IRC|Time to response is defined as the time from start of treatment until the first response (CR/CRi/nPR/PR). Response was determined according to the IWCLL updated NCI-WG guidelines, 2008. This analysis only included participants who had a response while in the study, there was no censoring.|From start of treatment until the first response (CR/CRi/nPR/PR) (up to Week 62.3)|All Subjects Population. Only those participants classified as responders (CR, CRi, PR, nPR) were evaluated.|||Weeks||95% Confidence Interval|Median
2662324|NCT01563055|Secondary|Overall Survival|Overall survival is defined as time from start of treatment until death due to any cause. For participants who did not die, time to death was censored at the time of the last date of contact.|From start of treatment until death (up to Week 62.3|All Subjects Population|||Weeks||95% Confidence Interval|Median
2662325|NCT01563055|Secondary|Progression-free Survival (PFS), as Assessed by the IRC and the Investigator|Progression free survival is defined as the time from start of treatment until disease progression (PD) or death due to any cause. PD was determined by the IRC or investigator according to the definitions of response in the IWCLL updated NCI-WG guidelines, 2008. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (>1.5 centimeter [cm]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 per microliter B-lymphocytes; transformation to a more aggressive histology; or occurrence of cytopenia attributable to chronic lymphocytic leukemia. PFS was censored at the last visit with adequate assessment for participants who were alive and had not progressed.|From start of treatment until disease progression or death (up to Week 62.3)|All Subjects Population. Only participants who progressed or died were analyzed.|||Weeks||95% Confidence Interval|Median
2662326|NCT01563055|Secondary|Number of Participants With CR, as Assessed by the IRC, IRC With CT, and the Investigator|Response was determined according to the IWCLL updated NCI-WG guidelines, 2008. According to the guidelines, CR (all the criteria at least 2 months after last treatment): peripheral blood lymphocytes below < 4,000/μL, no Ly > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; Neu >1500 /µL, PL >100,000/µL, Hb >11 g/dL, BM sample must be normocellular for age, <30% lymphocytes, no LN. PR: >=50% decrease in peripheral blood lymphocytes, Ly, size of liver and spleen; and blood count showing at least one of the following results: Neu>1500/μL, PL >100,000/µL or 50% improvement over BL, Hb >11 g/dL or 50% improvement over BL. No increase in LN and no new LN.|From start of treatment until disease progression or death (up to Week 62.3)|All Subjects Population|||Participants|||Number
2662327|NCT01563055|Primary|Number of Participants With Overall Response, as Assessed by the Independent Review Committee (IRC) With CT, IRC and Investigator|Response evaluated as per International Workshop for Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-sponsored Working Group (NCI-WG) Guidelines, 2008. Overall response rate (ORR) is defined as percentage of par. achieving complete remission (CR), nodular partial remission (nPR), CR-incomplete (CRi) or PR. CR (>=2 months after last treatment): lymphocytes (LC) <4000 per microliter (μL), no lymphadenopathy (Ly)>1.5 cm/hepatomegaly/splenomegaly/constitutional symptoms; neutrophils (N)>1500/µL, platelets (PL)>100,000/µL, hemoglobin (Hb)>11 grams/deciliter (g/dL), bone marrow (BM) sample must be normocellular for age,<30% LC, no lymphoid nodule (LN). PR:>=50% decrease in LC, Ly, size of liver and spleen; and at least one of these: N>1500/μL, PL>100,000/µL or 50% improvement over Baseline (BL), Hb>11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity.|From start of treatment until disease progression or death (up to Week 62.3)|All Subjects Population|||Participants|||Number
2662328|NCT01563055|Primary|Number of Participants Who Developed Toxicity Requiring Discontinuation From Study Treatment During Cycle 1|Tolerability of ofatumumab in combination with chlorambucil was evaluated based on the number of participants who developed toxicity requiring discontinuation from study treatment during Cycle 1. The treatment was considered tolerable when 0 of 3 participants, or <=2 of 6 participants developed toxicity which required discontinuation of study treatment during Cycle 1. The toxicity requiring discontinuation was determined based on the pre-defined withdrawal criteria.|From start of treatment through Cycle 1 (Week 4)|All Subjects Population: all participants who received at least one dose of investigational product.|||Participants|||Number
2662330|NCT01563029|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the PEF measurement. A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. The Baseline symptom-free value is defined as the percentage of symptom free 24-hr periods in the last 7 days of the run-in period. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. The analysis was performed using an ANCOVA model with covariates of Baseline, region, sex, actual pre-screening ICS use, age, and treatment group.|Baseline; Week 1 up to Week 12|ITT Population. Only participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
2662331|NCT01563029|Secondary|Change From Baseline in AM PEF Over the Last 7 Days of the Treatment Period (Week 12)|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline in AM PEF was calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, pre-screening ICS use, region, sex, age, and treatment. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurements.|Baseline; Week 12|ITT Population. Only participants available at the specified time points were analyzed.|||L/min||Standard Error|Least Squares Mean
2662332|NCT01563029|Secondary|Change From Baseline in PM PEF Over the Last 7 Days of the Treatment Period (Week 12)|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline in PM PEF was calculated as the value over the last 7 days of the Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, actual pre-screening ICS use, region, sex, age, and treatment. The LOCF method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement was used to impute the missing measurements.|Baseline; Week 12|ITT Population. Only participants available at the specified time points were analyzed.|||L/min||Standard Error|Least Squares Mean
2662333|NCT01563029|Secondary|Change From Baseline in Daily Evening (PM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period (at Week 12) minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using ANCOVA model with covariates of Baseline, actual pre-screening ICS use, region, sex, age, and treatment. Particpants analyzed included those who have PEF data for at least 2 non-missing days in the Baseline week prior to randomisation and at least 2 non-missing days after randomisation.|Baseline; Week 1 up to Week 12|ITT Population. Only participants available at the specified time points were analyzed.|||liters per minute (L/min)||Standard Error|Least Squares Mean
2662334|NCT01563029|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol aerosol (medication used to relieve symptoms immediately) used during the day and night) was recorded by the participants in a daily diary. A 24-hour (hr) period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. The Baseline rescue-free value was defined as the percentage of rescue-free 24-hr periods from the last 7 days of the Run-in Period. Change from Baseline was calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, actual pre-screening ICS use, age, and treatment.|Baseline; Week 1 up to Week 12|ITT Population. Only participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
2662335|NCT01563029|Secondary|Change From Baseline in Evening Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period in Children Who Could Perform the Maneuver|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as a pre-dose FEV1 measurement taken at a clinic visit while still on treatment. Change from Baseline was calculated as the Week 12 trough FEV1 value minus the Baseline value. The Baseline FEV1 value is defined as the value at Visit 3 (randomization). The analysis was performed using an ANCOVA model with covariates of Baseline trough FEV1, region, actual pre-screening ICS use, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing measurements. Only those participants available at the specified time points were analyzed.|Baseline, Week 12|ITT Population. Only participants available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2662353|NCT01562782|Secondary|Peak Glucose Levels in 2 Study Groups|A comparison of peak levels of glucose at one hour. Glucose is expected to increase after ingestion of glucose/fructose.|1 hour||||mmol/L||Standard Deviation|Mean
2662354|NCT01562782|Secondary|Fold Changes in VLDL Triglycerides in South Asians and Caucasians|1) A comparison of the fold changes in very low density lipoprotein triglycerides (VLDL TG)in the 2 study groups between 0 and 4 hours.|4 hours||||fold change||Standard Deviation|Mean
2662355|NCT01562782|Primary|Fold Change in Plasma Very Low Density Lipoprotein (VLDL) Triglyceride Palmitate|Fold change in plasma very low density lipoprotein (VLDL) triglyceride palmitate between South Asians and Caucasians from baseline to 4 hours after an oral challenge of fructose:glucose, 1:1.|4 hours||||fold change||Standard Deviation|Mean
2662336|NCT01563029|Primary|Change From Baseline in Daily Pre-dose Morning (AM) Peak Expiratory Flow (PEF) From Participant Electronic Daily Diary Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. The best of three measurements was recorded. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. The Baseline PEF value is defined as the average of the last 7 days of the Run-in Period. Statistical analysis was performed using an analysis of covariance (ANCOVA) model with covariates of Baseline AM PEF, actual pre-screening inhaled corticosteroid (ICS) use, region, sex, age, and treatment. Particpants analyzed included those who have PEF data for at least 2 non-missing days in the Baseline week prior to randomisation and at least 2 non-missing days after randomisation.|Baseline; Week 1 up to Week 12|ITT Population: participants randomized to treatment who received at least 1 dose of study medication. Only participants available at the specified time points were analyzed.|||Liters per minute (L/min)||Standard Deviation|Least Squares Mean
2662337|NCT01563003|Secondary|Clinical Global Impression - Severity Scale|Scale range - 0 (minimum) to 6 (maximum). Higher scores represent worse anxiety symptom severity.|After an average of 16 weeks (Post-treatment)||||units on a scale||Standard Deviation|Mean
2662338|NCT01563003|Secondary|Anxiety Disorders Interview Schedule Clinical Severity Rating|Scale range - 0 (minimum) to 8 (maximum). Higher scores represent worse anxiety symptom severity.|After an average of 16 weeks (Post-treatment)||||units on a scale||Standard Deviation|Mean
2662339|NCT01563003|Primary|Pediatric Anxiety Rating Scale|Scale range - 0 (minimum) to 25 (maximum). Higher scores represent worse anxiety symptom severity.|After an average of 16 weeks (Post-treatment)||||units on a scale||Standard Deviation|Mean
2662340|NCT01562886|Secondary|Number of Subjects With HIV Viral Load Above 50 Copies Per mL|Plasma viral load will be measured at all study visits to assess if viral load is above the lower limit of detection (50 copies mL)|Day 3,14, 28, 60, 80-100||||participants|||Number
2662341|NCT01562886|Primary|CSF:Plasma Ratio of Rilpivirine Levels|The levels of rilpivirine will be measured in the cerebral spinal fluid and plasma after 60 days of exposure|Day 60||||ratio expressed as a percentage||95% Confidence Interval|Geometric Mean
2662342|NCT01562873|Secondary|Progression-Free Survival|Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or equivocal progression of non-target lesions.|Disease was evaluated radiologically every 8 weeks on treatment through 12 cycles and in long-term follow-up every 4 months for up to 2 years. Median follow-up in this study cohort was 4.5 months (range 0.6-21.9).|The analysis dataset is comprised all enrolled patients.|||months||95% Confidence Interval|Median
2662343|NCT01562873|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.|In long-term follow-up, patients were followed for survival every 4 months for up to 2 years. Median follow-up in this study cohort was 4.5 months (range 0.6-21.9).|The analysis dataset is comprised all enrolled patients.|||months||95% Confidence Interval|Median
2662344|NCT01562873|Secondary|Clinical Benefit Rate|Clinical benefit rate (CBR) was defined as achieving complete response (CR), partial response (PR), or stable disease (SD) for 24 weeks or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria. SD needed to be a minimum 24 weeks in duration.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity up to 12 cycles. Treatment duration was a median of 2 cycles range (1-5).|The analysis dataset is comprised all enrolled patients.|||proportion of patients||90% Confidence Interval|Number
2662345|NCT01562873|Primary|Objective Response Rate|The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity up to 12 cycles. Treatment duration was a median of 2 cycles range (1-5).|The analysis dataset is comprised all enrolled patients.|||proportion of patients||90% Confidence Interval|Number
2662346|NCT01562782|Secondary|Peak Glucose in 2 Study Groups|A comparison of peak levels of glucose at 1 hour. Glucose is expected to increase after ingestion of glucose/fructose.|1 hour||||mmol/L||Standard Deviation|Mean
2662347|NCT01562782|Secondary|Nadir Non-esterified Fatty Acids (NEFA) Levels in 2 Study Groups|A comparison of the nadir level of non-esterified fatty acids (NEFA at 2 hours). NEFA are expected to decrease.|2 hours||||mmol/L||Standard Deviation|Mean
2662348|NCT01562782|Secondary|Peak Lactate Levels in 2 Study Groups|A comparison of peak levels of lactate (at one hour). Lactate is expected to increase after ingestion of glucose/fructose.|1 hour||||mmol/L||Standard Deviation|Mean
2662349|NCT01562782|Secondary|Fold Changes in Triglycerides in 2 Study Groups|1) A comparison of the fold changes in total triglycerides (TG) in the 2 study groups between 0 and 4 hours.|4 hours||||fold change||Standard Deviation|Mean
2662350|NCT01562782|Secondary|Correlations Between Fold Change in VLDL TG Palmitate and Other Biomarkers of Carbohydrate and Fat Metabolism|Correlations between fold change in VLDL TG palmitate at 4 hours with other biomarkers of carbohydrate and fat metabolism in each study group.|4 hours||||r (correlation coefficient)|||Number
2662356|NCT01562756|Primary|Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Study Duration.|Feasibility was measured by the study duration from study launch to collection of final study outcomes. This pilot study allowed for testing of equipment, finalizing the data collection protocol, and training study personnel before conducting the full-scale trial.|Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits||||months|months||Number
2662357|NCT01562756|Primary|Feasibility of Conducting a Full-scale Randomized Control Trial to Evaluate Patient Response to Spinal Manipulation: Number of Participants Who Were Recruited, Consented, Enrolled, and Completed the Study|Feasibility was measured by the numbers of participants: recruited, consented, enrolled, and retained. This pilot study allowed for testing of equipment, finalizing the data collection protocol, and training study personnel before conducting the full-scale trial.|Approximately 4-6 weeks including initial eligibility screening, baseline visits, and 2 weeks of treatment visits||||participants|||Number
2662358|NCT01562743|Secondary|Change of Short-Form 36-Item Health Survey (SF-36) From Baseline to Each Visit|SF-36 is a scale for assessing health status in clinical practice and research. The scores of 36 questions are summarized into 7 sub-scales. In each sub-scale which range is 0-100, a higher score indicates a better health status. Thus a increase in the scores means improvement.|Baseline, Up to 53 weeks|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2662359|NCT01562743|Primary|Change of the Pittsburgh Sleep Quality Index (PSQI) From Baseline to Each Visit|"PSQI is a scale for assessing severity of sleep disorders. The score ranges from 0 to 21. 0 indicates no difficulty and 21 indicates severe difficulty. A decrease in the scores means improvement."|Baseline, Up to 53 weeks|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2662360|NCT01562743|Secondary|Change of Augmentation Severity Rating Scale (ASRS) Sum Score From Baseline to Each Visit|"ASRS is a scale for assessing severity of augmentation. ASRS consists of 3 items (one item containing 4 sub-items). The sum of the score of each question serves as the scale score (each question score: 0-3, sum score 0-24).~A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement."|Baseline, Up to 52 weeks|FAS, LOCF|||Scores on a scale||Standard Deviation|Mean
2662361|NCT01562743|Secondary|Efficacy Rate in IRLS Sum Score|Efficacy rate (percentage of subjects with 50% decrease) (LOCF) in IRLS sum score.|Baseline, Up to 53 weeks|FAS, LOCF|||Percentage of participants||95% Confidence Interval|Number
2662362|NCT01562743|Secondary|Change of IRLS Sum Score From the Baseline to Each Visit|"IRLS is a scale for assessing severity of restless legs syndrome symptoms. IRLS consists of ten questions. Each question is scored from 4 for the first (top) answer (usually 'very severe') to 0 for the last answer (usually none).~The sum of the score of each question serves as the scale score. The scale scoring criteria are: Mild (score 1-10); Moderate (score 11-20); Severe (score 21-30); Very severe (score 31-40). A decrease in the scores means improvement."|Baseline, Up to 53 weeks|Full analysis set (FAS), last observation carried forward (LOCF)|||Scores on a scale||Standard Deviation|Mean
2662363|NCT01562743|Primary|Augmentation|"Augmentation is the main complication during long-term dopaminergic treatment of restless legs syndrome (RLS) and reflects an overall increase in RLS severity.~Augmentation is clinically significant when at least one of the following occurs:~Change in daily activities and/or behavior (e.g., the patient stops riding in cars in the afternoon) due to augmentation;~Negative impact on the patient's quality of life (sleep, mood, etc.) due to augmentation;~Need to change the treatment dose or the patienｔ needs to take the dose earlier in the day (e.g., dividing the dose);~Adjustments in concomitant medication are made to compensate for augmented RLS symptoms (e.g., an increased intake of analgesics or hypnotics to cover an increase in symptom intensity);~Any other aspect as judged by the evaluator (should be specified)."|Up to 53 weeks|SS|||participants|||Number
2662364|NCT01562743|Primary|The Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters|"The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of adverse events, vital signs, and laboratory parameters.~AEs of special interest (1-3) are defined as below:~sudden onset of sleep~obsessive-compulsive disorder or impulse-control disorder~hallucination, delusion"|Up to 54 weeks|Safety set (SS)|||participants|||Number
2662365|NCT01562678|Primary|Change Between Highly Desirable vs. Less Desirable Food Cues in the Effect Size of Cortical Activation During Food Visualization|Effect size (region of interest z-scores, derived from z-maps of the brain) shown below is the difference in parietal cortex activation to highly desirable (high fat or high calorie, e.g. cakes, pies, fries) versus less desirable (low fat or low calorie, e.g. vegetables, fruits) food cues for each treatment condition (liraglutide or placebo) at the end of the treatment period.|18 days of Liraglutide or placebo treatment|Participants with incomplete MRI scans were excluded from the analysis.|||z-scores of activation in cortex||Standard Error|Mean
2662366|NCT01562613|Secondary|Change in Framingham Stroke Risk Profile Scores of the Participating Patients|"The Framingham Stroke Risk Profile assesses the Probability of Stroke Within 10 Years separately for a) Women Aged 55-84 Years and Free of Previous Stroke AND b) for Men Aged 55-85 Years and Free of Previous Stroke.~First the Framingham Stroke Risk Profile Score is calculated as the sum of points obtained from each of the following factors: age, treated or untreated SBP, presence of diabetes, cigarette smoking, cardiovascular disease, atrial fibrillation, hypertension, and left ventricular hypertrophy according to the gender-specific tables provided by D'Agostino et al (Stroke 1994: 40-43). Subsequently the total score obtained yields the 10-year probability of stroke from gender-specific tables provided in D'Agostino et al.~The score can range from 0-38 (according to the scales of D' Agostino et al) with higher scores yielding increased 10-year probability of stroke."|Baseline up to 6 months|"Excluded from Framingham calculation were patients with either~a history of cerebrovascular accident~any of the parameters missing for the calculation of the Framingham~age <54 years or > 84 years for females & <54 or > 85 years for males"|||score on a scale||Full Range|Median
2662367|NCT01562613|Primary|The Absolute Change in Systolic Blood Pressure From Baseline|The absolute change in systolic Blood Pressure from baseline|Baseline up to 6 months||||mmHg||Standard Deviation|Mean
2662431|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
2662368|NCT01562613|Primary|The Percentage of Hypertensive Patients Who Achieve Regulated BP Levels According to the ESC/ESH Guidelines, After They Have Been Treated With Eprosartan for 6 Months Under Standard Daily Medical Practice Conditions.|"The percentage of hypertensive patients who achieve regulated BP levels according to the ESC/ESH (European Society of Cardiology/European Society of Hypertension) Guidelines, after they have been treated with eprosartan for 6 months under standard daily medical practice conditions.~Rate of responders (%) who reach the ESH/ESC Guidelines BP levels of <140 mmHg/90 mmHg [systolic BP (SBP)/diastolic BP (DBP)] for the general population of hypertensive patients OR of <130 mmHg/80 mmHg in case of diabetics and high or very high risk patients such as those with associated clinical conditions [stroke, myocardial infarction, coronary artery disease (CAD)]"|Baseline up to 6 months||||Percentage of participants||95% Confidence Interval|Number
2662369|NCT01562548|Secondary|Global Assessment of Headache Intensity (GAHI)|Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||participants|||Number
2662370|NCT01562548|Secondary|Global Assessment of Headache Frequency (GAHF)|Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||participants|||Number
2662371|NCT01562548|Secondary|Global Assessment of Sleep Disturbance (GASD)|Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||participants|||Number
2662372|NCT01562548|Secondary|Global Assessment of Treatment Helpfulness (GATH)|Measured as an overall qualitative score on a 5 point categorical scale: 0-poor, 1-fair, 2-good, 3-very good and 4-excellent.|4 Days, 7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2662373|NCT01562548|Secondary|Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores|Vernon-Mior upper back/neck/shoulder components were assessed before the treatment and at Days 4 and 7. Each component (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation) was assessed based on a 6-point categorical scale (1 to 6), with 1 being the most positive and 6 being the worst.|Before treatment, 4 Days, 7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2662374|NCT01562548|Secondary|Muscle Relaxation Scores|The score was measured as mean of both AM and PM assessment scores at Days 4 and 7. Measurements were based on a 5 categorical scale: 0 - no relaxation, 1- a little relaxation, 2 - fair relaxation, 3 - good relaxation, 4 - complete muscle relaxation.|4 Days, 7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2662375|NCT01562548|Secondary|Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no discomfort to 10 - unbearable discomfort.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2662376|NCT01562548|Secondary|Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no pain to 10 - unbearable pain.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2662377|NCT01562548|Secondary|Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no tension to 10 - unbearable tension.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2662378|NCT01562548|Secondary|Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no stiffness to 10 - unbearable stiffness.|7 Days|Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who receive at least one dose of study medication and who had at least one post-baseline efficacy assessment.|||Score on a scale||Standard Deviation|Mean
2662379|NCT01562548|Primary|Mean Change From Baseline of Both AM and PM Spasm Assessment Scores|The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no spasm to 10 - unbearable spasm.|7 Days|Efficacy analysis was conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment. Subjects were analyzed according to the treatment to which they were randomized.|||Score on a Scale||Standard Deviation|Mean
2663018|NCT01556763|Primary|EVP-6124 Time to Maximum Concentration (Tmax), Patients on Paliperidone/Risperidone|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving paliperidone/risperidone.|||hr||Full Range|Median
2662380|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662381|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662382|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662383|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662384|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662385|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662386|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662387|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662388|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662389|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662390|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662391|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662392|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662393|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662394|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662395|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662396|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662397|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662398|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662399|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662400|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662401|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662402|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662403|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662404|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662405|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662406|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662407|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662408|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662409|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662410|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 60 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662411|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 60 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662457|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2|Antibody titers were measured by GSK NT assay.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
2662412|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 60 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662413|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 60 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662414|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 60 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662415|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 50 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662416|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 50 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662417|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 50 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662418|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 50 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662419|NCT01562444|Primary|Evaluation of GMTs in the Age Group of ≥ 50 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662432|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
2662420|NCT01562444|Primary|Evaluation of GMTs in the Age Group of 15-49 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662421|NCT01562444|Primary|Evaluation of GMTs in the Age Group of 15-49 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662422|NCT01562444|Primary|Evaluation of GMTs in the Age Group of 15-49 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662423|NCT01562444|Primary|Evaluation of GMTs in the Age Group of 15-49 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662424|NCT01562444|Primary|Evaluation of GMTs in the Age Group of 15-49 Years|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662425|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
2662426|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
2662427|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
2662428|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Number of subjects||95% Confidence Interval|Number
2662429|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
2662430|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
2662433|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
2662434|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups|Age groups defined based on age at entry to V48P7E1 study: 15 to 49 years, ≥ 50 years, and ≥ 60 years.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
2662435|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662436|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662437|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662438|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662439|NCT01562444|Primary|GMRs Calculated to Post Booster Baselines|GMR values were tabulated by vaccine schedule using post booster vaccination titers as baseline. Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662440|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662441|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662442|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662443|NCT01562444|Primary|GMRs Calculated to Pre Booster Baselines|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662444|NCT01562444|Primary|Geometric Mean Ratios (GMRs) Calculated to Pre Booster Baselines|GMR values were tabulated by vaccine schedule using pre booster vaccination titers as baseline. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start).|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Ratios||95% Confidence Interval|Geometric Mean
2662445|NCT01562444|Primary|Evaluation of GMTs|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662446|NCT01562444|Primary|Evaluation of GMTs|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662447|NCT01562444|Primary|Evaluation of GMTs|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662448|NCT01562444|Primary|Evaluation of GMTs|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate GMRs. Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662449|NCT01562444|Primary|Evaluation of Geometric Mean Antibody Titers (GMTs)|GMTs by visit were tabulated for each vaccine schedule. Baselines pre booster and post booster vaccination titers were used as denominators to calculate Geometric Mean Ratios (GMRs). Pre booster vaccination titer: GMT at Day 0 of V48P7E1 prior to booster vaccine administration (excluding subjects who received the booster before V48P7E1 study start). Post booster vaccination titer: GMT at Day 21 of V48P7E1 (for subjects who received booster in V48P7E1); Day 0 for subjects who received booster before V48P7E1 study start.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Titers||95% Confidence Interval|Geometric Mean
2662450|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10|Antibody titers were measured by GSK NT assay.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
2662451|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10|Antibody titers were measured by GSK NT assay.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
2662452|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10|Antibody titers were measured by GSK NT assay.|At Year 8|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
2662453|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10|Antibody titers were measured by GSK NT assay.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
2662454|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10|Antibody titers were measured by GSK NT assay.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
2662455|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2|Antibody titers were measured by GSK NT assay.|At Year 10|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
2662456|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2|Antibody titers were measured by GSK NT assay.|At Year 9|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
2662458|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2|Antibody titers were measured by GSK NT assay.|At Year 7|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
2662459|NCT01562444|Primary|Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2|Antibody titers were measured by GlaxoSmithKline (GSK) neutralizing antibody (NT) assay.|At Year 6|This analysis was performed on All Screened Set which included all subjects who were screened for participation of this study, including screening failures and withdrawals due to insufficient antibody levels or confirmed exposure to a TBE vaccine.|||Percentage of subjects||95% Confidence Interval|Number
2662460|NCT01562379|Other Pre-specified|Maternal Knowledge, Attitude and Practice Related to Infant and Young Child Feeding|Maternal KAP|At 6, 12 and 18 months of age|||||||
2662461|NCT01562379|Secondary|Intestinal Function|Intestinal function using L:M and other biomarkers will be assessed by intervention group and its association with child growth|At 24 months of age|||||||
2662462|NCT01562379|Secondary|Micronutrient Status|Iron, vitamin A, zinc and other micronutrient status of children will be examined by intervention group.|18 months of age|||||||
2662463|NCT01562379|Secondary|Cognitive and Motor Function|Using Bayley III|At 18 months of age|||||||
2662464|NCT01562379|Secondary|Developmental Milestones|Age-specific developmental milestones will be assessed|At 6, 12, and 18 months of age|||||||
2662465|NCT01562379|Secondary|Body Composition|Bioelectrical impedance analysis will be used to look at body composition changes from baseline until 18 months of age|At 6, 9 and 12 months of age|||||||
2662466|NCT01562379|Secondary|Morbidity|weekly morbidity will be assessed for a year and episodes of diarrhea, dysentery ALRI, and fever will be recorded.|weekly from 6 to 18 months of age|||||||
2662467|NCT01562379|Primary|Stunting in Children at 18 mo|Prevalence of stunting at 18 months of age.|18 months of age|Children followed after 1 year of supplementation from 6 months at 18 months of age|||Participants|||Count of Participants
2662468|NCT01562327|Secondary|Percentage of Participants With an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug.|approximately 3 years|Safety population was defined as all participants who received at least one dose of Tocilizumab.|||percentage of participants|||Number
2662469|NCT01562327|Secondary|Change From Baseline in Patient's Severity of Morning Stiffness at Month 3 and Month 6|Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.|||units on a scale||Full Range|Median
2662470|NCT01562327|Secondary|Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6|The Patient Global Assessment of pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.|||units on a scale||Full Range|Median
2662471|NCT01562327|Secondary|Change From Baseline in Patient's Global Assessment of Fatigue at Month 3 and Month 6|The Patient Global Assessment of fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue and 100 indicates extreme fatigue. A decrease in the score indicates improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.|||units on a scale||Full Range|Median
2662472|NCT01562327|Secondary|Percentage of Participants With Clinical Remission in Health Assessment Questionnaire Disability Index (HAQ-DI)|The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ-DI scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measure at the specified time point.|||percentage of participants|||Number
2662473|NCT01562327|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6|The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.|||units on a scale||Full Range|Median
2662474|NCT01562327|Secondary|Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6|"The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.|||units on a scale||Full Range|Median
2662487|NCT01562327|Secondary|Number of Participants Who Stopped Biologic Agents Prior to Start of Tocilizumab||Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.|||participants|||Number
2662475|NCT01562327|Secondary|Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6|ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement. ACR50, ACR70, ACR90 require a 50%, 70%, 90% improvement from baseline respectively.|Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure. Here, 'n' represents the number of participants with a measure at the specified time point.|||percentage of participants|||Number
2662476|NCT01562327|Secondary|European League Against Rheumatism (EULAR) Response|Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH, and ESR. DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (>=) -0.6, DAS28 >3.2 to <=5.1 or CFB>=-0.6 and DAS28 >5.1 or CFB >=-0.6.|Month 3, Month 6|Data was not collected, hence not reported.||||||
2662477|NCT01562327|Secondary|Simplified Disease Activity (SDAI) Response Classification|The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP). SDAI total score = 0-86. A SDAI score </= 3.3 represented clinical remission, a score of between 3.4 and 11.0 represented low disease activity, a score between 11 and 26.0 represented moderate disease activity and a score > 26.0 represented high (or severe) disease.|Month 3, Month 6|Data was not collected, hence not reported.||||||
2662478|NCT01562327|Secondary|Clinical Disease Activity Index (CDAI) Response Classification at Month 3 and Month 6|CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician global assessment of disease activity (PhGH) assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.|Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure.|||participants|||Number
2662479|NCT01562327|Secondary|Disease Activity Score-28 (DAS 28) Response Classification at Month 3 and Moth 6|DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and patient global assessment of disease activity (PGH) (measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 is a measurement of RA activity on a 0 to 10 scale: a score greater than (>) 5.1 indicates high disease activity; a score between 3.2 and 5.1 indicates moderate disease activity; a score of less than 3.2 indicates low disease activity; a score of less than (<) 2.6 is considered remission.|Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure. Here, 'n' represents the number of participants with a measure at the specified time point.|||participants|||Number
2662480|NCT01562327|Secondary|Change From Baseline in Swollen Joint Count (SJC) at Month 3 and Month 6|The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 28 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28. A decrease in score indicates improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measure at the specified time point.|||units on a scale||Full Range|Median
2662481|NCT01562327|Secondary|Change From Baseline in Tender Joint Count (TJC) at Month 3 and Month 6|The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 28 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28. A decrease in score indicated improvement.|Baseline, Month 3, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measure at the specified time point.|||units on a scale||Full Range|Median
2662482|NCT01562327|Secondary|Percentage of Participants on Tocilizumab as Monotherapy or Combination Therapy|Percentage of participants on Tocilizumab as monotherapy or combination therapy (with DMARDs) were reported at start of treatment and at 6 months from the start of treatment.|Baseline, Month 6|FAS was defined as all participants who received at least one dose of Tocilizumab.|||percentage of participants|||Number
2662483|NCT01562327|Secondary|Percentage of Participants Who Discontinued From Tocilizumab for Safety Versus Efficacy||Approximately 3 years|FAS was defined as all participants who received at least one dose of Tocilizumab.|||percentage of participants|||Number
2662484|NCT01562327|Secondary|Reasons for Dose Modifications||approximately 3 years|FAS was defined as all participants who received at least one dose of Tocilizumab.|||participants|||Number
2662485|NCT01562327|Secondary|Reason for Biologic Agent Withdrawal at Baseline||Baseline|FAS defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure.|||participants|||Number
2662486|NCT01562327|Secondary|Percentage of Participants Who Previously Received Biologic Agents||Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.|||percentage of participants|||Number
2662491|NCT01562327|Secondary|Percentage of Participants With Systemic Manifestations of RA at Baseline|Systemic manifestations of RA included anemia, fatigue, conventional risk factors for cardiovascular disease, C-Reactive Protein (CRP) above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis and interstitial lung disease. Participants were included if they experienced at least one of the conditions.|Baseline|FAS was defined as all participants who received at least one dose of Tocilizumab.|||percentage of participants|||Number
2662492|NCT01562327|Primary|Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation||6 months after treatment initiation|The Full Analysis Set (FAS) was defined as all participants who received at least one dose of Tocilizumab.|||percentage of participants||95% Confidence Interval|Number
2662493|NCT01562314|Post-Hoc|Change From Baseline To EOT In Levels Of Fecal Calprotectin- PP Analysis|Fecal calprotectin is a marker of inflammation. Standard methods were used to measure the levels of calprotectin in fecal samples collected at the end of baseline and treatment periods. A negative change from Baseline indicates that levels of fecal calprotectin decreased.|Baseline to EOT (10 weeks) or ET|PP analysis set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy. Not all participants contributed data for this outcome measure.|||ug/g||Standard Deviation|Mean
2662494|NCT01562314|Post-Hoc|Change From Baseline To EOT In The Mayo Partial Score - PP Analysis Set|The Mayo score is an assessment of ulcerative colitis activity. The Mayo partial score does not include the endoscopy findings sub-score and ranges from 0 to 9 points with higher scores indicating more severe disease. The partial score is made up of 3 sub-scores (assessed by using a 0 to 3 scale). The sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; PGAS: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. A negative change from Baseline indicates that symptoms improved.|Baseline to EOT (10 weeks) or ET|PP Analysis Set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy.|||units on a scale||Standard Deviation|Mean
2662495|NCT01562314|Post-Hoc|Change From Baseline To EOT In The Mayo Total Score - PP Analysis|The Mayo score is an assessment of ulcerative colitis activity. The Mayo total score ranges from 0 to 12 points with higher scores indicating more severe disease. The total score is made up of 4 sub-scores (assessed using a 0 to 3 scale). The sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; Findings on Endoscopy: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration); PGAS: 0 = none, 1 = mild, 2 = moderate, and 3 = severe. A negative change from Baseline indicates that symptoms improved.|Baseline to EOT (10 weeks) or ET|PP analysis set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy. Not all participants contributed data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2662496|NCT01562314|Secondary|Change From Baseline To EOT In Levels Of Fecal Calprotectin|Fecal calprotectin is a marker of inflammation. Standard methods were used to measure the levels of calprotectin in fecal samples collected at the end of baseline and treatment periods. A negative change from Baseline indicates that levels of fecal calprotectin decreased.|Baseline to EOT (10 weeks) or ET|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized. Not all participants contributed data for this outcome measure.|||microgram calprotectin/gram feces (ug/g)||Standard Deviation|Mean
2662497|NCT01562314|Secondary|Change From Baseline To EOT In The Mayo Partial Score|The Mayo score is an assessment of ulcerative colitis activity. The Mayo partial score does not include the endoscopy findings sub-score and ranges from 0 to 9 points with higher scores indicating more severe disease. The partial score is made up of 3 sub-scores (assessed by using a 0 to 3 scale). The sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; PGAS: 0 = none, 1 = mild, 2 = moderate and 3 = severe. A negative change from Baseline indicates that symptoms improved.|Baseline to EOT (10 weeks) or ET|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized. Not all participants contributed data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2662498|NCT01562314|Secondary|Change From Baseline To EOT In The Mayo Total Score|The Mayo score is an assessment of ulcerative colitis activity. The Mayo total score ranges from 0 to 12 points with higher scores indicating more severe disease. The total score is made up of 4 sub-scores (assessed using a 0 to 3 scale). The sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; Findings on Endoscopy: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration); PGAS: 0 = none, 1 = mild, 2 = moderate and 3 = severe. A negative change from Baseline indicates that symptoms improved.|Baseline to EOT (10 weeks) or ET|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized. Not all participants contributed data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2662591|NCT01561313|Primary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|The primary response variable is participant's immediate pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm), with 0 representing no pain and 10 representing the worst possible pain.|Immediately after injection||||cm||Standard Deviation|Mean
2662499|NCT01562314|Secondary|Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Rectal Bleeding NRS - PP Analysis|Participants were required to record their rectal bleeding during the baseline and treatment periods in a daily diary. Participants graded rectal bleeding with a 4-point NRS as follows: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes. For analysis, the baseline value was defined as the mean rectal bleeding score of the last 7 available days of the baseline period; the EOT value was defined as the mean rectal bleeding score of last 7 days of the treatment period, or last 7 days for which study drug was taken, where earlier. A negative change from Baseline indicates that symptoms improved.|Baseline to EOT (last 7 days) or ET|PP analysis set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy.|||units on a scale||Standard Deviation|Mean
2662500|NCT01562314|Secondary|Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Rectal Bleeding NRS|Participants were required to record their rectal bleeding during the baseline and treatment periods in a daily diary. Participants graded rectal bleeding with a 4-point NRS as follows: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes. For analysis, the baseline value was defined as the mean rectal bleeding score of the last 7 available days of the baseline period; the EOT value was defined as the mean rectal bleeding score of last 7 days of the treatment period, or last 7 days for which study drug was taken, where earlier. A negative change from Baseline indicates that symptoms improved.|Baseline to EOT (last 7 days) or ET|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized. Not all participants contributed data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2662501|NCT01562314|Secondary|Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Stool Frequency NRS - PP Analysis|Participants were required to record their stool frequency during the baseline and treatment periods in a daily diary. Participants graded stool frequency with a 4-point NRS as follows: 0 = Normal number of stools; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal. For analysis, the baseline value was defined as the mean stool frequency score of the last 7 available days of the baseline period; the EOT value was defined as the mean stool frequency score of last 7 days of the treatment period, or last 7 days for which study drug was taken, where earlier. A negative change from Baseline indicates that symptoms improved.|Baseline to EOT (last 7 days) or ET|PP analysis set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy.|||units on a scale||Standard Deviation|Mean
2662502|NCT01562314|Secondary|Change From Baseline To The Last Week Of Treatment In Ulcerative Colitis Symptoms, As Measured By Scores On The Stool Frequency Numerical Rating Scale (NRS)|Participants were required to record their stool frequency during the baseline and treatment periods in a daily diary. Participants graded stool frequency with a 4-point NRS as follows: 0 = Normal number of stools; 1 = 1 to 2 stools more than normal; 2 = 3 to 4 stools more than normal; 3 = 5 or more stools more than normal. For analysis, the baseline value was defined as the mean stool frequency score of the last 7 available days of the baseline period; the EOT value was defined as the mean stool frequency score of last 7 days of the treatment period, or last 7 days for which study drug was taken, where earlier. A negative change from Baseline indicates that symptoms improved.|Baseline to EOT (last 7 days) or ET|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized. Not all participants contributed data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2662503|NCT01562314|Secondary|Number Of Participants Who Reported An Improvement In The SGIC Questionnaire At EOT - PP Analysis|"Participants were asked to answer the following question by using a 7-point scale (1 = very much better to 7 = very much worse): Please assess the change in your ulcerative colitis symptoms since immediately before receiving the first dose of study treatment. Improvement was considered as very much better, much better, or minimally better."|Visit 4 (Day 43) to EOT (10 weeks) or ET|PP analysis set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy. Not all participants contributed data for this outcome measure.|||Participants|||Count of Participants
2662504|NCT01562314|Secondary|Number Of Participants Who Reported An Improvement In The Subject Global Impression Of Change (SGIC) Questionnaire At EOT|"Participants were asked to answer the following question by using a 7-point scale (1 = very much better to 7 = very much worse): Please assess the change in your ulcerative colitis symptoms since immediately before receiving the first dose of study treatment. Improvement was considered as very much better, much better, or minimally better."|Visit 4 (Day 43) to EOT (10 weeks) or ET|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized. Not all participants contributed data for this outcome measure.|||Participants|||Count of Participants
2662505|NCT01562314|Secondary|Change From Baseline To EOT In The IBDQ Total Score - PP Analysis|The IBDQ is a validated and reliable tool to measure health-related quality of life in adult participants with IBD. Each of the 32 questions falls into 1 of 4 domains (bowel symptoms, systemic symptoms, emotional status and social function). The 32 questions each have 7 possible responses. Each response is assigned a score ranging from 1 to 7, indicating the severity (1 being least favorable and 7 being the most favorable). Individual question scores were summed to give the IBDQ total score (range: 32 to 224 points). A positive change from Baseline indicates that symptoms improved.|Baseline to EOT (10 weeks) or ET|PP analysis set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy. Not all participants contributed data for this outcome measure.|||units on a scale||Standard Deviation|Mean
2662543|NCT01561989|Secondary|Occurrences of Flu-like Illnesses (Intervention Component)|occurrences of flu like illness (intervention arm)|From initial treatment until the end of study (April 1, 2012); up to 24-weeks.|No subjects were treated prior to study closure due to lack of accrual. Therefore, no outcome measures were recorded and no statistical analyses were performed.||||||
2662506|NCT01562314|Secondary|Change From Baseline To EOT In The Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score|The IBDQ is a validated and reliable tool to measure health-related quality of life in adult participants with inflammatory bowel disease (IBD). Each of the 32 questions falls into 1 of 4 domains (bowel symptoms, systemic symptoms, emotional status and social function). The 32 questions each have 7 possible responses. Each response is assigned a score ranging from 1 to 7, indicating the severity (1 being least favorable and 7 being the most favorable). Individual question scores were summed to give the IBDQ total score (range: 32 to 224 points). A positive change from Baseline indicates that symptoms improved.|Baseline to EOT (10 weeks) or ET|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized. Not all participants contributed data for the outcome measure.|||units on a scale||Standard Error|Mean
2662507|NCT01562314|Secondary|Change From Baseline To EOT In The PGAS Score - PP Analysis|The PGAS required the physician to assess participants' disease severity on a 4-point scale (0=normal [no disease], 1 = mild disease, 2 = moderate disease, 3 = severe disease). A negative change from Baseline indicates that symptoms decreased.|Baseline to EOT (10 weeks) or ET|PP analysis set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy.|||units on a scale||Standard Deviation|Mean
2662508|NCT01562314|Secondary|Change From Baseline To EOT In The PGAS Score|The PGAS required the physician to assess participants' disease severity on a 4-point scale (0=normal [no disease], 1 = mild disease, 2 = moderate disease, 3 = severe disease). A negative change from Baseline indicates that symptoms decreased.|Baseline to EOT (10 weeks) or ET|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized. Not all participants contributed data to this outcome measure.|||units on a scale||Standard Deviation|Mean
2662509|NCT01562314|Secondary|Distribution On The PGAS At EOT - PP Analysis|The PGAS required the physician to assess participants' disease severity on a 4-point scale (0 = normal [no disease], 1 = mild disease, 2 = moderate disease, 3 = severe disease).|EOT (10 weeks) or ET|PP analysis set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy.|||Participants|||Count of Participants
2662510|NCT01562314|Secondary|Distribution On The PGAS At EOT|The PGAS required the physician to assess participants' disease severity on a 4-point scale (0=normal [no disease], 1 = mild disease, 2 = moderate disease, 3 = severe disease).|EOT (10 weeks) or ET|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized. Not all participants contributed data for this outcome measure.|||Participants|||Count of Participants
2662511|NCT01562314|Primary|Number Of Participants With A Mayo Score Of 2 Or Less (With No Sub-score >1) At EOT - PP Analysis|The Mayo score is an assessment of ulcerative colitis activity. The Mayo total score ranges from 0 to 12 points with higher scores indicating more severe disease. The total score is made up of 4 sub-scores, each of which is assessed using a 0 to 3 scale. Sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; Findings on Endoscopy: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration); PGAS: 0 = none, 1 = mild, 2 = moderate, and 3 = severe.|Baseline to EOT (10 weeks) or ET|PP analysis set: all participants who completed the 10-week randomized phase of the study with no protocol violations deemed to compromise the assessments of efficacy.|||Participants|||Count of Participants
2662512|NCT01562314|Primary|Number Of Participants With A Mayo Score Of 2 Or Less (With No Sub-score >1) At EOT|The Mayo score is an assessment of ulcerative colitis activity. The Mayo total score ranges from 0 to 12 points with higher scores indicating more severe disease. The total score is made up of 4 sub-scores, each of which is assessed using a 0 to 3 scale. Sub-scores are graded as follows: Stool Frequency: 0 = Normal number of stools, 1 = 1 to 2 stools more than normal, 2 = 3 to 4 stools more than normal, 3 = 5 or more stools more than normal; Rectal Bleeding: 0 = No blood seen, 1 = Streaks of blood with stool less than half the time, 2 = Obvious blood with stool most of the time or more, 3 = Blood alone passes; Findings on Endoscopy: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration); Physician's Global Assessment of Illness Severity (PGAS): 0 = none, 1 = mild, 2 = moderate, and 3 = severe.|Baseline to End of Treatment (EOT) (10 weeks) or Early Termination (ET)|ITT analysis set: all participants who were randomized and received at least 1 dose of study drug. Participants were analyzed according to the group to which they were randomized.|||Participants|||Count of Participants
2662513|NCT01562275|Secondary|Progression-Free Survival (PFS) Time for Participants With Measurable Disease According to RECIST v1.1|PFS is defined as the time from study treatment initiation to the first occurrence of disease progression, as determined by investigator review of tumor assessments using RECIST 1.1, or death from any cause during the study (i.e., within 30 days after the last dose of study treatment).|Screening, Days 21-28 of Cycle 2, Day 25 (± 3 days) of Cycle 4 and every 8 weeks thereafter till study completion (Up to 33 months)|This outcome measure was not analyzed as per changes in planned analysis due to very few participants with measurable response.||||||
2662514|NCT01562275|Secondary|Duration of Objective Response for Participants With Measurable Disease According to RECIST v1.1|Duration of response, defined as the time from first occurrence of a documented objective response until the time of disease progression, as determined by investigator review of tumor assessments using RECIST 1.1, or death from any cause during the study (i.e., within 30 days after the last dose of study treatment).|Screening, Days 21-28 of Cycle 2, Day 25 (± 3 days) of Cycle 4 and every 8 weeks thereafter till study completion (Up to 33 months)|This outcome measure was not analyzed as per changes in planned analysis due to very few participants with measurable response.||||||
2663019|NCT01556763|Primary|EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Paliperidone/Risperidone|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving paliperidone/risperidone.|||pg/mL||Standard Deviation|Mean
2662515|NCT01562275|Secondary|Number of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|RECIST v1.1 (for measurable disease), CR: disappearance of all target lesions, reduction in short axis <10 millimeters in pathological lymph nodes (target and non-target lesions); PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were confirmed by repeat assessments ≥4 weeks after initial documentation.|Screening, Days 21-28 of Cycle 2, Day 25 (± 3 days) of Cycle 4 and every 8 weeks thereafter till study completion (Up to 33 months)|Safety analysis population.|||participants|||Number
2662516|NCT01562275|Secondary|Last Measurable Concentration (Clast) of Ipatasertib and Cobimetinib on Day 1 and Day 15||Predose (0 hour), 1, 2, 4, 6 and 24 hours postdose on Day 1 and Day 15 of Cycle 1|"Pharmacokinetic analysis population. n represents the number of participants who were evaluable for that particular assessment."|||ng/mL||Standard Deviation|Mean
2662517|NCT01562275|Secondary|Time Taken to Reach Cmax (Tmax) of Ipatasertib and Cobimetinib on Day 1 and Day 15||Predose (0 hour), 1, 2, 4, 6 and 24 hours postdose on Day 1 and Day 15 of Cycle 1|"Pharmacokinetic analysis population. n represents the number of participants who were evaluable for that particular assessment."|||hours||Full Range|Median
2662518|NCT01562275|Secondary|Maximum Plasma Concentration (Cmax) of Ipatasertib and Cobimetinib on Day 1 and Day 15||Predose (0 hour), 1, 2, 4, 6 and 24 hours postdose on Day 1 and Day 15 of Cycle 1|"Pharmacokinetic analysis population. n represents the number of participants who were evaluable for that particular assessment."|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2662519|NCT01562275|Secondary|Area Under Concentration-Time Curve From Time Zero to Last Measurable Concentration After Dose [AUC0-Last] of Ipatasertib and Cobimetinib on Day 1 and Day 15||Predose (0 hour), 1, 2, 4, 6 and 24 hours postdose on Day 1 and Day 15 of Cycle 1|"Pharmacokinetic analysis population: Included all participants who received study treatment and had at least 1 cobimetinib and ipatasertib plasma concentration available. n represents the number of participants who were evaluable for that particular assessment."|||nanograms*hours/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2662520|NCT01562275|Primary|Number of Participants With At Least One AE Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version (V) 4.0|AE was defined in Outcome Measure 3. AEs were graded as per NCI CTCAE V 4.0 as follows: G 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL) (instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money and others); G 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL (refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden); G 4: Life-threatening consequences, urgent intervention indicated; G 5: Death related to AE. If a participant had multiple events of different grades, the highest grade that occurred in that participant was counted.|From Baseline up to 30 days after the last dose of study treatment or until initiation of another anticancer treatment whichever occurred first (Up to 33 months)|Safety analysis population.|||participants|||Number
2662521|NCT01562275|Primary|Maximum Tolerated Doses (MTDs) in Combination of Cobimetinib and Ipatasertib During Dose-Escalation Stage 1|An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. On the basis of AEs that did not meet protocol-defined DLT criteria (defined in Outcome measure 1) but indicated intolerability of a given dose combination, the combination MTDs were determined (as per investigator) during Stage 1 of the study.|Cycle 1 (28 Days)|Safety analysis population participants from dose escalation cohorts.|||milligrams|||Number
2662522|NCT01562275|Primary|Number of DLTs Categorized as Per the Nature|DLT is defined as 1 of the following toxicities considered by the investigator to be possibly related to study drugs: a) G ≥3 febrile neutropenia, b) G ≥4 neutropenia (ANC <500/μL) lasting >5 days , c) G ≥4 thrombocytopenia lasting >2 days, d) G ≥4 anemia, e) G ≥3 elevation of total bilirubin or hepatic transaminase or ALP lasting >3 days, f) Hepatic transaminases >3 × ULN and an increase in total bilirubin >2 × ULN without any findings of cholestasis and in the absence of other contributory factors, g) G ≥2 visual changes that do not resolve to baseline within 14 days, h) 1 episode of fasting G 4 hyperglycemia or 3 episodes of fasting, i) G 3 hyperglycemia on separate days within 7 days, j) G ≥4 fasting hypercholesterolemia or triglyceridemia for ≥2 weeks, k) G ≥3 nausea, vomiting, or diarrhea despite maximal supportive medications lasting for ≥3 days. Hematologic, Hepatic and non-hematologic and non-hepatic DLT categories were to be reported.|Cycle 1 (28 Days)|Data for this outcome measure was not analyzed as no participant experienced DLT.||||||
2662523|NCT01562275|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT is defined as 1 of the following toxicities considered by the investigator to be possibly related to study drugs: a) Grade (G) ≥3 febrile neutropenia, b) G ≥4 neutropenia (absolute neutrophil count [ANC] <500/ microliter [μL]) lasting >5 days , c) G ≥4 thrombocytopenia lasting >2 days, d) G ≥4 anemia, e) G ≥3 elevation of total bilirubin or hepatic transaminase or alkaline phosphatase (ALP) lasting >3 days, f) Hepatic transaminases >3 × Upper Limit of Normal (ULN) and an increase in total bilirubin >2 × ULN without any findings of cholestasis and in the absence of other contributory factors, g) G ≥2 visual changes that do not resolve to baseline within 14 days, h) 1 episode of fasting G 4 hyperglycemia or 3 episodes of fasting, i) G 3 hyperglycemia on separate days within 7 days, j) G ≥4 fasting hypercholesterolemia or triglyceridemia for ≥2 weeks, k) G ≥3 nausea, vomiting, or diarrhea despite maximal supportive medications lasting for ≥3 days.|Cycle 1 (28 Days)|Safety analysis set included all participants who received at least 1 dose of study treatment. This outcome was analyzed in safety analysis population participants in dose escalation cohorts.|||participants|||Number
2662524|NCT01562132|Secondary|Cryptococcal Meningitis-free Survival at 24 Weeks|"Clinical meningitis AND at least one of the following: cryptococcal antigen in the cerebrospinal fluid (CSF), cryptococcal organisms on India Ink stain, or fungal culture of CSF.~Clinical meningitis will be defined as:~fever>39.0°C, AND~severe headache, AND~At least one of the following:~meningismus,~photophobia,~new onset seizure,~focal neurological deficit localizable to the central nervous system~papilledema~confusion, delirium, or decreased level of consciousness."|24 weeks|||||||
2662530|NCT01562132|Secondary|Number of Individuals Who Develop Immune Reconstitution Inflammatory Syndrome Due to Cryptococcus|"Individuals who develop clinical meningitis without evidence of fungal, bacterial, or parasitic (e.g. malaria) organisms in the cerebrospinal fluid. Clinical meningitis will be defined as:~fever>39.0°C, AND~severe headache, AND~At least one of the following:~meningismus,~photophobia,~new onset seizure,~focal neurological deficit localizable to the central nervous system~papilledema~confusion, delirium, or decreased level of consciousness."|24 weeks|||||||
2662531|NCT01562132|Secondary|Number of Individuals Who Develop Cryptococcal Meningitis|"Clinical meningitis AND at least one of the following: cryptococcal antigen in the cerebrospinal fluid (CSF), cryptococcal organisms on India Ink stain, or fungal culture of CSF.~Clinical meningitis will be defined as:~fever>39.0°C, AND~severe headache, AND~At least one of the following:~meningismus,~photophobia,~new onset seizure,~focal neurological deficit localizable to the central nervous system~papilledema~confusion, delirium, or decreased level of consciousness."|24 weeks|||||||
2662532|NCT01562132|Secondary|Survival at 24 Weeks||24 weeks|||||||
2662533|NCT01562132|Secondary|Survival at 2 Weeks||2 weeks|||||||
2662534|NCT01562132|Primary|Survival at 12 Weeks||12 weeks||||participants|||Number
2662535|NCT01562028|Secondary|Adverse Events|Adverse events graded according to NCI CTCAE V4.|Assessed across all time-points until end of treatment (30 +/-5 days following the last dose of study drug) (max 48 months).|Three patients never started treatment (2 lost to follow-up, one from each arm and 1 withdrawal from T790M negative arm).|||Participants|||Count of Participants
2662536|NCT01562028|Secondary|Duration of Response|"Interval from the date of first documentation of objective response (CR or PR) to the date of first documented progression or relapse. Assessment of Objective response and Progressive Disease (PD) is based on the RECIST 1.1 criteria:~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.~Progression (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on the trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on the trial."|Assessed across all time-points from enrollment to to the date of first documented progression or relapse (max 48 months).||||months||95% Confidence Interval|Median
2662537|NCT01562028|Secondary|Disease Control|"Disease control is defined as achieving objective response (CR or PR, across all time-points from enrollment to termination of trial treatment) or stable disease for at least 6 weeks. Objective response, along with SD (disease control) and PD (no disease control), will be determined using RECIST 1.1 criteria:~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.Progression (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on the trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on the trial."|Assessed across all time-points from enrollment to termination of trial treatment (max 48 months).||||Participants|||Count of Participants
2662538|NCT01562028|Secondary|Objective Response|"Objective response is defined as best overall response (CR or PR) across all assessment time-points during the period from enrollment to termination of trial treatment. Objective response, along with progressive and stable disease, will be determined using RECIST 1.1 criteria:~Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.~Progression (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on the trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on the trial."|Assessed across all time-points from enrollment to termination of trial treatment (max 48 months).|Patients with only 1 tumor assessment are classified as “Non-Evaluable”, because they cannot be accounted for the Objective Response rate.|||Participants|||Count of Participants
2662539|NCT01562028|Secondary|Time to Treatment Failure|Time from the date of enrollment to discontinuation of treatment for any reason including progression of disease (based on RECIST v1.1), treatment toxicity (adverse events classified according to NCI CTCAE version 4.), refusal and death.|From the date of enrollment until discontinuation of treatment, assessed up to 48 months.||||months||95% Confidence Interval|Median
2662540|NCT01562028|Secondary|Overall Survival|Time from the date of enrollment until death from any cause.|From the date of enrollment until death, assessed up to 48 months.||||months||95% Confidence Interval|Median
2662541|NCT01562028|Primary|Progression Free Survival|"Time from the date of enrollment until an investigator-documented progression or death, whichever occurs first.~Assessment of Progressive Disease (PD) is based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum recorded on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm."|From the date of enrollment until documented progression or death, whichever occurs first, assessed up to 48 months.||||months||95% Confidence Interval|Median
2662542|NCT01561989|Secondary|Association Between SNPs and Polymorphisms in the DNA Sequence of Vitamin-D3 Metabolizing Enzymes, Measures of Vitamin-D3 Metabolism (24,25 OH Vitamin D3) and Response to Seasonal (2012-201) Trivalent Influenza Vaccine (Intervention Component)|Association between SNPs and polymorphisms in the DNA sequence of vitamin-D3 metabolizing enzymes, measures of vitamin-D3 metabolism (24,25 OH vitamin D3) and response to seasonal (2012-201) trivalent influenza vaccine (Intervention component)|Up to 24 weeks|No subjects were treated prior to study closure due to lack of accrual. Therefore, no outcome measures were recorded and no statistical analyses were performed.||||||
2662574|NCT01561469|Secondary|Duration of Hospital Stay|Duration of hospital stay was assessed as number of days from VAP diagnosis to discharge from the hospital.|Up to 28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.|||days||Inter-Quartile Range|Median
2662544|NCT01561989|Secondary|Relationship Between 25-hydroxy Vitamin D3 Levels at Time of Vaccination and Immunologic Responses Following Administration of the Injected Seasonal (2012-2013) Trivalent Influenza Vaccine (Intervention Component)|Relationship between 25-hydroxy vitamin D3 levels at time of vaccination and immunologic responses following administration of the injected seasonal (2012-2013) trivalent influenza vaccine (Intervention component)|Up to week 24|No subjects were treated prior to study closure due to lack of accrual. Therefore, no outcome measures were recorded and no statistical analyses were performed.||||||
2662545|NCT01561989|Secondary|Occurrences of Flu-like Illness (Observational Component)|occurrences of flu-like illness|Up to April 1, 2012|No subjects were treated prior to study closure due to lack of accrual. Therefore, no outcome measures were recorded and no statistical analyses were performed.||||||
2662546|NCT01561989|Primary|Effect of Cholecalciferol Supplementation on Immunologic Response (Antibody Response) to Injectable Seasonal (2012-2013) Trivalent Influenza Vaccine (Intervention Component)|Descriptive statistics will be used to assess for differences in the occurrence of self-reported flu-like illnesses in the study population. Will be estimated with confidence intervals at each time point. Tested by Wald Chi-square test, and the odds ratio (with confidence intervals) will be reported.|Up to 24 weeks post-vaccination|unable to accrue participants, study closed, no analyses completed.||||||
2662547|NCT01561989|Primary|Effect of 25-hydroxy Vitamin D3 Levels on Immunologic Response (Antibody Responses) to Injectable Seasonal (2011-2012) Trivalent Influenza Vaccine (Observational Component)|Descriptive statistics and chi-square tests will be used to assess for differences in the occurrence of self-reported flu-like illnesses in the study population.|At 4 weeks post-vaccination|No subjects were treated prior to study closure due to lack of accrual.||||||
2662548|NCT01561976|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect, medically significant or possible drug-induced liver injury.|Up to approximately 24 days (during treatment and washout) after initiation of study|PK Population.|||Participants|||Count of Participants
2662549|NCT01561976|Secondary|Terminal Phase Half Life (t1/2)|PK blood samples for estimation of t1/2 were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population. Only those participants available at the indicated time points were analyzed.|||Hour||Full Range|Median
2662550|NCT01561976|Secondary|Elimination Constant (Kel)|PK blood samples for estimation of Kel were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population. Only those participants available at the indicated time points were analyzed.|||Fraction/hour||Full Range|Median
2662551|NCT01561976|Secondary|PK Lag Time (Tlag)|PK blood samples for estimation of Tlag were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population. Only those participants available at the indicated time points were analyzed.|||Hour||Full Range|Median
2662552|NCT01561976|Secondary|Time of Occurrence of Cmax (Tmax)|PK blood samples for estimation of Tmax were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population. Only those participants available at the indicated time points were analyzed.|||Hour||Full Range|Median
2662553|NCT01561976|Secondary|AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration Within a Participant Across All Treatments [AUC (0-t)]|PK blood samples for estimation of AUC (0-t) were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population. Only those participants available at the indicated time points were analyzed.|||µ.hr/mL||Geometric Coefficient of Variation|Geometric Mean
2662554|NCT01561976|Primary|Area Under Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC (0-infinity)]|PK blood samples for estimation of AUC (0-infinity) were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population. Only those participants available at the indicated time points were analyzed.|||Micrograms hour per milliliter (µ.hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2662575|NCT01561469|Secondary|Number of Participants With Microbiological Outcome|Microbiological outcome was defined as superinfections (infections diagnosed within 72 hours of the diagnosis of HAP and until day 28) and colonization (positive cultures with a multi-drug resistant organism).|28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.|||participants|||Number
2662555|NCT01561976|Primary|Maximum Observed Concentration (Cmax)|Pharmacokinetic (PK) blood samples for estimation of Cmax were collected at 0.0 (pre-dose) and 0.5,1,2,2.5,3,3.5,4,4.5,5,6,7,8,10, 12, 16,24 and 30 hours after dosing. Point estimates and corresponding 90% confidence interval was constructed for the ratio of the geometric mean of the test treatment (fed condition) to the geometric mean of the reference treatment (fasting condition).|0.0 (pre-dose) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 24 and 30 hours after dosing|PK Population included participants who received study medication. Only those participants available at the indicated time points were analyzed.|||Nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2662556|NCT01561898|Primary|Incidence of Adverse Events|The incidence of adverse events was measured by the percentage of patients who presented one or more adverse events.|48 weeks|Intent-to-treat (ITT) population|||percentage of patients|||Number
2662557|NCT01561898|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S)|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill patients."|Baseline, Week 48|Intent-to-treat (ITT) population|||scores on a scale||Standard Deviation|Mean
2662558|NCT01561898|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS)|PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline, Week 48|Intent-to-treat (ITT) population|||scores on a scale||Standard Deviation|Mean
2662559|NCT01561755|Secondary|Impression of Change Score - Clinician|The clinician measure of Global Impression of Change reflects the clinician's view about the efficacy of treatment as measured by 1. Marked improvement; 2 Moderate Improvement; 3 Minimal Improvement; 4 No Change; 5 Minimal Worsening; 6 Moderate Worsening; 7 Marked worsening|at 2 months||||units on a scale||Full Range|Mean
2662560|NCT01561755|Secondary|Impression of Change Score - Participant|The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment 1. Marked improvement; 2 Moderate Improvement; 3 Minimal Improvement; 4 No Change; 5 Minimal Worsening; 6 Moderate Worsening; 7 Marked worsening|at 2 months||||units on a scale||Full Range|Mean
2662561|NCT01561755|Secondary|Hughes Function Score|0 = Normal strength; 1 = minor symptoms but capable of running; 2 = The subject is able to walk 30 ft. but unable to run; 3 = The subject is able to walk 30 ft. with the assistance of one person; 4 = A walker or cane; 5 = The subject is unable to walk.|at 2 months||||units on a scale||Full Range|Mean
2662562|NCT01561755|Secondary|Bowel Function|0 = No bowel problems, 1 = Asymptomatic on current drug tx or constipation not requiring any tx, 2 = Constipation requiring laxative or suppositories or fecal urgency, 3 = Constipation requiring the use of an enema, 4 = Constipation requiring manual evacuation of stools or occasional fecal incontinence (once or more during the last month but not every week, 5 = Weekly fecal incontinence|2 months||||units on a scale||Full Range|Mean
2662563|NCT01561755|Secondary|Urinary Function|0 = Normal bladder function, 1 = Asymptomatic on current treatment, 2 = Urinary frequency, hesitancy, urgency, with no incontinence, 3 = Occasional urinary incontinence (once or more during the last month but not every week) or intermittent catheterization, 4 = Frequent urinary incontinence, or occasional incontinence despite regular catheterization, 5 = Daily urinary incontinence or permanent catheter|2 months||||units on a scale||Full Range|Mean
2662564|NCT01561755|Secondary|Walking Test|2 minute walking test|at 2 months|One participant in placebo group in wheelchair and unable to complete the walking test|||meters||Standard Deviation|Mean
2662565|NCT01561755|Primary|Strength Scores|Strength score as measured by pounds of force sustained in lower extremity strength.|at 2 months||||pounds of force||Standard Deviation|Mean
2662566|NCT01561716|Primary|Energy Expenditure|Energy expenditure is measured using continuous, computerized open-circuit indirect calorimetry (oxygen consumption and carbon dioxide production) and converted to metabolic equivalents (METs).|30 min continuous monitoring at rest and during each physical activity||||METs||Standard Deviation|Mean
2662567|NCT01561703|Primary|Healthcare Utilization|Questionnaire designed to evaluate healthcare utilization following surgery. Unit of measure will be the number of participants utilizing each category of healthcare.|6 wks post-operative appointment||||participants|||Number
2662568|NCT01561560|Primary|End-of-day Comfort|"End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, Please rate the study lenses you have been wearing the in the following area: End-of-day comfort and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent)."|Week 2|This reporting group includes all participants who finished the study, minus any major protocol deviations as determined by masked review.|||Units on a scale||Standard Deviation|Mean
2662569|NCT01561495|Primary|Number of Adverse Events|Given this is initially a feasibility study- the primary measure is number of AEs (Adverse Events).|4 years|Investigator and study team are unreachable after having left Penn despite multiple efforts to contact for more information- as such no data is available to present||||||
2662570|NCT01561469|Secondary|Number of Antibiotic Free Days||Up to 28 days after diagnosis of VAP|Data was not analyzed for this outcome because other reported measures (that is, duration of antimicrobial treatment, duration of mechanical ventilation, duration of ICU stay, duration of hospital stay) were considered to represent a more strict and useful reflection of resource utilization.||||||
2662571|NCT01561469|Secondary|Duration of Antimicrobial Treatment||Up to 28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.|||days||Standard Deviation|Mean
2662572|NCT01561469|Secondary|Duration of Mechanical Ventilation|Duration of mechanical ventilation was assessed as number of days from VAP diagnosis to extubation or to discharge if not extubated.|Up to 28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.|||days||Inter-Quartile Range|Median
2662573|NCT01561469|Secondary|Duration of Intensive Care Unit (ICU) Stay|Duration of ICU stay was assessed as number of days from VAP diagnosis to discharge from the ICU.|Up to 28 days after diagnosis of VAP|Analysis population included all participants who met the eligibility criteria for this study.|||days||Inter-Quartile Range|Median
2662576|NCT01561469|Primary|Percentage of Participants With Clinical Success|Clinical success was assessed as number of participants cured or improved. Cure = complete resolution of signs and symptoms of pneumonia; Improvement = partial resolution of signs and symptoms of pneumonia.|14 days after diagnosis with VAP or hospital discharge, whichever occurred first|Analysis population included all participants who met the eligibility criteria for this study.|||percentage of participants|||Number
2662577|NCT01561430|Secondary|Change From Baseline in Cerebrospinal Fluid (CSF) Tau and Phosphorylated Tau (Ptau)-181 Concentrations|Percent change in lumbar CSF tau and ptau-181 concentrations from baseline at 12 weeks post-dose and 26 weeks post-dose was calculated. The units for CSF were picograms per milliliter (pg/mL). Least Squares (LS) means of percent change in concentration from baseline was calculated using analysis of covariance (ANCOVA) with baseline as a covariate and treatment as a fixed effect.|Baseline, 12 weeks, 26 weeks|"All randomized participants at 12 weeks with evaluable post-baseline CSF Tau or Ptau data.~Zero participants analyzed for 26 week CSF Tau or Ptau as data was not collected for analysis."|||percent change in tau and ptau-181||Standard Error|Least Squares Mean
2662578|NCT01561430|Secondary|Change From Baseline to 26 Weeks in Mini Mental State Examination (MMSE)|The MMSE (Folstein et al. 1975) is one of the most widely used screening instruments for cognitive impairment. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and provides a total score ranging from 0 to 30, with lower scores indicative of greater cognitive impairment. LS means were calculated using MMRM with Treatment + Visit + Treatment*Visit + Baseline + Baseline*Visit.|Baseline, 26 weeks|All randomized participants with evaluable MMSE data.|||units on a scale||Standard Error|Least Squares Mean
2662579|NCT01561430|Secondary|Change From Baseline to 26 Weeks in the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)|The CDR-SB is a composite measure of 6 domains of cognitive and functional performance: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Scores ranged from 0 to 18, with higher scores indicating greater impairment. LS means were calculated using MMRM with Treatment + Visit + Treatment*Visit + Baseline + Baseline*Visit.|Baseline, 26 weeks|All randomized participants with evaluable CDR-SB data.|||units on a scale||Standard Error|Least Squares Mean
2662580|NCT01561430|Secondary|Change From Baseline to 26 Weeks in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)|ADAS-Cog11 is an 11-item instrument measuring impairment in memory (Items 1-4, 7, 11), praxis (Items 4 and 5), orientation (Item 6), and language (Items 8-10). Item 1 ranged 0 (all items recalled correctly)-10 (none recalled correctly); Items 2-5 and 8-11 ranged 0 (all items named, performed, drawn, spoken, remember correctly/clearly)-5 (none correct/not clearly spoken); Item 6 ranged 0 (no incorrect responses)-8 (all incorrect); and Item 7 ranged 0 (all words remembered correctly)-12 (no words remembered correctly) for a total ADAS-Cog11 score of 0-70 with higher scores indicating greater disease severity. A score of 0-10 for delayed free recall and a conversion code of 0-5 for digit cancellation and maze completion was added to the total ADAS-Cog11 score for a total ADAS‑Cog14 score ranging 0-90 with higher scores indicating greater impairment. LS means were calculated using Mixed Model Repeated Measures (MMRM) with Treatment + Visit + Treatment*Visit + Baseline + Baseline*Visit.|Baseline, 26 weeks|All randomized participants with evaluable ADAS-Cog data.|||units on a scale||Standard Error|Least Squares Mean
2662581|NCT01561430|Secondary|Change From Baseline to 26 Weeks in Neuropsychological Test Battery (NTB)|The NTB is a composite cognitive measure in clinical Alzheimer's disease studies and is a collection of several written and oral tests that examines verbal and nonverbal brain functions. NTB Z-score typically ranges from -3 to 3, with lower scores suggesting greater cognitive impairment. LS means were calculated using ANCOVA with baseline as a covariate and treatment as a fixed effect.|Baseline, 26 weeks|All randomized participants with evaluable NTB data.|||units on a scale||Standard Error|Least Squares Mean
2662582|NCT01561430|Secondary|Change From Baseline in Plasma Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations|Percent change in plasma concentrations of Aβ1-40 and Aβ1-42 from baseline at 12 weeks and 26 weeks post-dose was calculated. The units for CSF were picograms per milliliter (pg/mL).|Baseline, 12 weeks, 26 weeks|All randomized participants with evaluable post-baseline CSF Aβ1-40 or Aβ1-42 data.|||percent change in Aβ1-40 and Aβ1-42||Standard Deviation|Mean
2662583|NCT01561430|Primary|Change From Baseline to 26 Weeks in CSF Aβ1-40 and Aβ1-42 Concentrations|Percent change in lumbar CSF concentrations of Aβ1-40 and Aβ1-42 from baseline at 26 weeks post-dose was to be calculated. The units for CSF were picograms per milliliter (pg/mL). LS means of percent change in concentration from baseline was calculated using ANCOVA with baseline as a covariate and treatment as a fixed effect.|Baseline, 26 weeks|Zero participants analyzed. CSF Aβ1-40 and Aβ1-42 concentrations data was not collected for analysis at 26 weeks.||||||
2662584|NCT01561430|Primary|Change From Baseline to 12 Weeks in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations|Percent change in lumbar CSF concentrations of Aβ1-40 and Aβ1-42 from baseline at 12 weeks post-dose was calculated. The units for CSF were picograms per milliliter (pg/mL). Least Squares (LS) means of percent change in concentration from baseline was calculated using analysis of covariance (ANCOVA) with baseline as a covariate and treatment as a fixed effect.|Baseline, 12 weeks|All randomized participants with evaluable post-baseline CSF Aβ1-40 or Aβ1-42 data.|||percent change in Aβ1-40 and Aβ1-42||Standard Error|Least Squares Mean
2662585|NCT01561313|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.|Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. Serious Adverse Events were collected from the time the participant signed the informed consent.||||participants|||Number
2662586|NCT01561313|Secondary|Percentage of Participants With no Pruritus in the Draize Scale|Pruritus (itching) was assessed.|10 minutes and 30 minutes after injection||||Percentage of Participants|||Number
2662587|NCT01561313|Secondary|Percentage of Participants With no Edema in the Draize Scale|Edema (swelling) was assessed.|10 minutes and 30 minutes after injection||||Percentage of Participants|||Number
2662588|NCT01561313|Secondary|Percentage of Participants With no Erythema in the Draize Scale|Erythema (redness) was assessed.|10 minutes and 30 minutes after injection||||Percentage of Participants|||Number
2662592|NCT01561300|Secondary|Chronic Effect of Tea vs Control|"Change in flow mediated dilation (FMD) due to tea consumption when compared to control.~FMD measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (baseline)~5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease~4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion"|From baseline at day 1 to baseline on day 8|Per protocol based on the full data set excluding one subject who did produce relevant data (AE) and three subjects who were removed during blind review (operator comments, hypertension and increase in body weight). Single data points were removed for 6 subjects (all single data points) based on operator comments.|||Percentage change in flow mediated dilat||95% Confidence Interval|Least Squares Mean
2662593|NCT01561300|Secondary|Acute Effect of Tea vs Control|"Change in flow mediated dilation due to tea consumption when compared to control.~FMD measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (baseline)~5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease~4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion"|From baseline on day 1 to 2 hours post consumption on day 1|Per protocol based on the full data set excluding one subject who did produce relevant data (AE) and three subjects who were removed during blind review (operator comments, hypertension and increase in body weight). Single data points were removed for 6 subjects (all single data points) based on operator comments.|||percent change in flow mediated dilation||95% Confidence Interval|Least Squares Mean
2662594|NCT01561300|Primary|'Acute-upon-chronic Effect' of Tea vs Control|"Change in flow mediated dilation (FMD) due to tea consumption when compared to control.~FMD measurement included the following steps:~1 minute base scan to measure the baseline diameter of artery (baseline)~5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease~4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion"|Baseline day 1 to 2 hours post consumption on day 8.|Per protocol based on the full data set excluding one subject who did produce relevant data (AE) and three subjects who were removed during blind review (operator comments, hypertension and increase in body weight). Single data points were removed for 6 subjects (all single data points) based on operator comments.|||percentage of change in diameter||95% Confidence Interval|Least Squares Mean
2662595|NCT01561079|Primary|Fetal Movement - Fetal Heart Rate Coupling|The integration between fetal movements and heart rate (FM-FHR coupling) was quantified as the proportion of time individual movements were associated with a change in FHR, using previously developed criteria. FM-FHR coupling reflects coactivation of the sympathetic and parasympathetic components of the autonomic nervous system.|24, 28, 32, 36 weeks of gestation||||percentage of time FM assoc w FHR change||Standard Deviation|Mean
2662596|NCT01561079|Primary|Fetal Movement|Fetal movement (number x duration of fetal movements) during the 60 minute recordings at times of trough and peak maternal buprenorphine levels|24, 28, 32, 36 weeks of gestation||||seconds||Standard Deviation|Mean
2662597|NCT01561079|Primary|Accelerations of Fetal Heart Rate|Number of accelerations of fetal heart rate exhibited during the 60 minute recordings|24, 28, 32 36 weeks of gestation||||accelerations||95% Confidence Interval|Mean
2662598|NCT01561079|Primary|Fetal Heart Rate Variability|Fetal heart rate variability at 24, 28, 32 and 36 weeks of gestation at times of trough and peak maternal buprenorphine levels|24, 28, 32 and 36 weeks of gestation|Per protocol|||msec||Standard Deviation|Mean
2662599|NCT01561079|Primary|Fetal Heart Rate|Fetal heart rate in beats per minute at time of trough and peak maternal buprenorphine levels|24, 28, 32 and 36 weeks of gestation|Participants active in the protocol at 24, 28, 32 and 36 weeks, respectively|||beats per minute||Standard Deviation|Mean
2662600|NCT01561053|Other Pre-specified|ADCS-ADL Total Score (Changes From Baseline to 14 Months) in Patients With Baseline MMSE:18-21|"ADCS-ADL total score as a change from baseline to 14 months in patients with baseline Mini-Mental State Examination (MMSE):18-21~The ADCS-ADL comprises 23 questions covering a wide array of activities of daily living. Many of the activities begin with an assessment of whether that activity is relevant and then, if yes, follow with an assessment of the difficulty. The total score over all activities ranges from 0-78 where a higher score indicates more autonomy (better outcome)."|Baseline and 14 months|Evaluable population with baseline MMSE:18-21 and with ADCS-ADL measurement at 14 months|||units on a scale||Standard Error|Least Squares Mean
2662601|NCT01561053|Other Pre-specified|ADAS-Cog Total Score (Changes From Baseline to 14 Months) in Patients With Baseline MMSE:18-21|"ADAS-Cog score as a change from baseline to 14 months in patients with baseline Mini-Mental State Examination (MMSE):18-21~The ADAS-Cog Scale is a questionnaire that assesses cognitive performance in 12 different domains. The domains are: word recall, commands, constructional praxis, delayed word-recall task, naming objects/figures, ideational praxis, orientation, word recognition, remembering test instructions, comprehension, word finding difficulty, and spoken language ability. The total score ranges from 0-80 where a higher score indicates more cognitive impairment"|Baseline and 14 months|Evaluable population with baseline MMSE:18-21 and with ADAS-Cog measurement at 14 months|||units on a scale||Standard Error|Least Squares Mean
2662602|NCT01561053|Other Pre-specified|ADCS-ADL Total Score (Changes From Baseline to 14 Months) in Patients With Baseline MMSE:22-26|"ADCS-ADL total score as a change from baseline to 14 months in patients with baseline Mini-Mental State Examination (MMSE):22-26~The ADCS-ADL comprises 23 questions covering a wide array of activities of daily living. Many of the activities begin with an assessment of whether that activity is relevant and then, if yes, follow with an assessment of the difficulty. The total score over all activities ranges from 0-78 where a higher score indicates more autonomy (better outcome)."|Baseline and 14 months|Evaluable population with baseline MMSE:22-26 and with ADCS-ADL measurement at 14 months|||units on a scale||Standard Error|Least Squares Mean
2662625|NCT01560871|Secondary|Six-minute Walk Test Distance|The six-minute walk test is a measure of cardiovascular endurance which measures how far a person can walk in 6 minutes. This test was conducted twice respectively at pre-training and at post-training to account for potential learning effect. A longer distance walked on the six-minute walking test indicates a better cardiovascular endurance.|Baseline and 6 Weeks||||meters||Full Range|Mean
2662603|NCT01561053|Other Pre-specified|ADAS-Cog Total Score (Changes From Baseline to 14 Months) in Patients With Baseline MMSE:22-26|"ADAS-Cog total score as a change from baseline to 14 months in patients with baseline Mini-Mental State Examination (MMSE):22-26~The ADAS-Cog Scale is a questionnaire that assesses cognitive performance in 12 different domains. The domains are: word recall, commands, constructional praxis, delayed word-recall task, naming objects/figures, ideational praxis, orientation, word recognition, remembering test instructions, comprehension, word finding difficulty, and spoken language ability. The total score ranges from 0-80 where a higher score indicates more cognitive impairment."|Baseline and 14 months|Evaluable population with baseline MMSE:22-26 and with ADAS-Cog measurement at 14 months|||units on a scale||Standard Error|Least Squares Mean
2662604|NCT01561053|Primary|Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score (Changes From Baseline to 14 Months)|"ADCS-ADL total score as a change from baseline to 14 months~The ADCS-ADL comprises 23 questions covering a wide array of activities of daily living. Many of the activities begin with an assessment of whether that activity is relevant and then, if yes, follow with an assessment of the difficulty. The total score over all activities ranges from 0-78 where a higher score indicates more autonomy (better outcome)."|Baseline and 14 Months|Evaluable population with ADCS-ADL measurement at 14 months|||units on a scale||Standard Error|Least Squares Mean
2662605|NCT01561053|Primary|Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score (Changes From Baseline to 14 Months)|"ADAS-Cog total score as a change from baseline to 14 months~The ADAS-Cog Scale is a questionnaire that assesses cognitive performance in 12 different domains. The domains are: word recall, commands, constructional praxis, delayed word-recall task, naming objects/figures, ideational praxis, orientation, word recognition, remembering test instructions, comprehension, word finding difficulty, and spoken language ability. The total score ranges from 0-80 where a higher score indicates more cognitive impairment."|Baseline and 14 months|Evaluable population with ADAS-Cog measurement at 14 months|||units on a scale||Standard Error|Least Squares Mean
2662606|NCT01560988|Secondary|Genotype-specific Differences in Change in Lung Function While Receiving Borage and Echium Oils Versus Corn Oil.|FEV1 was measured in all subjects at the beginning and end of both study arms. Subjects were genotyped at LTC4S locus and those bearing at least one A to C polymorphism were compared with those bearing two A alleles.|0, 42, 84, and 126 days|We analyzed all samples available including subjects who did not complete the entire protocol. Therefore the number of subjects analyzed differs from the total number of subjects per arm.|||Liters||Standard Deviation|Mean
2662607|NCT01560988|Secondary|Change in Activity of LTC4 Synthase|Differences in LTC4S activity while receiving borage/echium oils versus corn oil stratified by LTC4S genotype. We analyzed the genotype for 32 subjects for the borage arm and 30 subjects for the placebo arm.|Days 0, 42, 84, and 126|Since this is a crossover study, 30 of 32 who completed the borage arm also completed the corn oil arm. The data presented reflect the effects of borage/echium versus corn oil for individuals with two wild type alleles (AA) versus those with one variant allele (CC or AC).|||ng/million cells||Standard Deviation|Mean
2662608|NCT01560988|Secondary|Measure of EPA in Cell Pellets|Secondary outcome measures include changes in concentrations of omega 3 fatty acids in cell pellets, indicating incorporation of botanical oil metabolites in cell membrane lipids.. This was calculated by the difference between the amount present at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta).|Assessed at 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm|||ng||Standard Deviation|Mean
2662609|NCT01560988|Secondary|Asthma Control|Changes in asthma control will be assessed via the Asthma Control Questionnaire (ACQ) at each visit. The ACQ is a 6-point questionnaire that reflects the degree of asthma activity. Each point is assigned a scale of 0-5, with 5 being the worst. Thus, the range is from 0 (no asthma symptoms) to 30 (severe asthma symptoms). For each arm, we generate two values (week 2 vs. week 8 and week 14 vs.week 20). These values are then averaged for each arm to obtain the final single value. A negative number implies improved symptoms.|Assessed at 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm|||Change in ACQ points||Standard Deviation|Mean
2662610|NCT01560988|Secondary|Number of Subjects Bearing a Polymorphic Variant of LTC4 Synthase|All individuals will be genotyped at the LTC4S locus.|two weeks|We analyzed all samples available including those who did not complete both arms of the protocol. Therefore the number of subjects in the two arms are not identical.|||participants|||Number
2662611|NCT01560988|Secondary|Plasma Level of Gamma Linolenic Acid (GLA)|Changes in plasma level of gamma linolenic acid (GLA), a major constituent of Borage oil, as a measure of compliance. This was calculated by the difference between the amount produced at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta).|Measurements obtained at 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm|||ng||Standard Deviation|Mean
2662612|NCT01560988|Secondary|Lung Function|Changes in lung function (forced expiratory volume in 1 second) will be assessed via spirometry at each visit. This was calculated by the difference between the FEV1 at weeks 2 and 8 versus weeks 14 and 20. The differences were compared as a delta-delta. A negative number for this parameter means that the FEV1 was lower at the end of the arm than at the beginning, while a positive number means that the FEV1 was higher at the end.|Assessed at 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm|||Percent change||Standard Deviation|Mean
2662613|NCT01560988|Secondary|Measure of DHA in Cell Pellets|Secondary outcome measures include changes in concentrations of omega 3 fatty acids in cell pellets, indicating incorporation of botanical oil metabolites in cell membrane lipids.. This was calculated by the difference between the amount present at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta).|Assessed at 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm|||ng||Standard Deviation|Mean
2662614|NCT01560988|Primary|Change in LTB4 Production|Primary outcome measures will be changes in the generation of LTB4 production by granulocytes. This was calculated by the difference between the amount produced at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta). A negative number implies that the level of LTB4 produced by granulocytes at the end of the arm was less than the amount produced at the start of the arm, while a positive number means that more was generated at the end than at the beginning.|At 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm|||ng||Standard Deviation|Mean
2662615|NCT01560988|Primary|Cellular Changes That Occur With Borage and Echium Seed Oil Supplementation|Primary outcome measures will be changes in the generation of LTC4 production by granulocytes. This was calculated by the difference between the amount produced at the start of each arm and at the end of each arm (i.e., two values were obtained in each arm and used to calculate the difference, and the differences were compared as a delta-delta).|Assessed at 2, 8, 14, and 20 weeks|We analyzed all samples available, including from subjects who did not complete the entire protocol (i.e., 40 subjects crossed over and completed both arms, but 44 completed the corn oil and 44 completed the borage and echium arm, and the overlap was incomplete). Thus, the number of subjects differs from the total number of subjects per arm.|||ng||Standard Deviation|Mean
2662616|NCT01560975|Secondary|Effect After CPAP Removal on the IOP Pattern|IOP pattern immediately after CPAP removal upon waking in patients with or without POAG|30 min||||mvEq||Standard Deviation|Mean
2662617|NCT01560975|Secondary|Relationship Between the 24-hour IOP Fluctuation Patterns and Physiologic Parameters|"Heart rate and ocular pulsation rate during sleep:~using CPAP in patients with or without POAG~not using CPAP in patients with or without POAG"|24-hours||||Correlation||Standard Deviation|Mean
2662618|NCT01560975|Primary|Relationship Between IOP Fluctuation Pattern With or Without CPAP Therapy in Patients With Moderate to Severe OSAS With or Without POAG|"24-hour IOP fluctuation pattern recorded using Triggerfish in patients with moderate to severe OSAS.~using CPAP in patients with or without POAG~not using CPAP in patients with or without POAG"|24 hours||||mVEq/h||Standard Deviation|Mean
2662619|NCT01560923|Secondary|Ratio of Antibodies to PA2024|"Assess the augmentation of immune response (PA2024) to sipuleucel-T measured at 14 weeks from first leukapheresis, in response to twice daily oral Indoximod at a dose of 1200 mg/day or an identical looking placebo.~The frequency of antigen specific, cytokine producing cells will be determined by an ELISPOT assay. ELISPOT assay will use whole PBMC to assess interferon gamma production in response to the immunizing protein PA2024.~Antibodies to PA2024 is measured by ELISA. The ratio of antibodies to ELISPOT responses to PBMC in patients in the treatment arm will be compared to those in control arm."|14 Weeks from First Leukapheresis||||Ratio||95% Confidence Interval|Geometric Mean
2662620|NCT01560923|Secondary|Quality of Life Scale Results|measured by the performance status with scale of 0-5 0 being 'normal activity' and 5 'being dead'|6 Months||||Participants|||Count of Participants
2662621|NCT01560923|Secondary|Overall Survival|To evaluate 2 year overall survival|2 years||||Participants|||Count of Participants
2662622|NCT01560923|Secondary|Objective Response Rate|"rate as defined by Prostate Cancer Working Group -2 (PCWG2). ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST)(version 1.1) Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesion.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|4 weeks||||Participants|||Count of Participants
2662623|NCT01560923|Secondary|Number of Participants With Progression Free Survival at 6 Months|"Progression free survival (PFS) is a composite endpoint defined as disease progression in bone or soft tissues, PSA progression, worsening pain, or death. PFS will be measured in months from the time of study enrollment until the date of disease progression.~Progression is evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009]. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria."|6 Months||||Participants|||Count of Participants
2662624|NCT01560923|Primary|Immune Response to Sipuleucel-T|"Assess the augmentation of immune response (PA2024) to sipuleucel-T measured at 14 weeks from first leukapheresis, in response to twice daily oral Indoximod at a dose of 1200 mg/day or an identical looking placebo.~The frequency of antigen specific, cytokine producing cells will be determined by an ELISPOT assay. ELISPOT assay will use whole PBMC to assess interferon gamma production in response to the immunizing protein PA2024. Increase in number of ELISPOT responses to PBMC in patients in the treatment arm will be compared to those in control arm."|14 Weeks from First Leukapheresis||||Spots per ml||95% Confidence Interval|Geometric Mean
2662626|NCT01560871|Secondary|Respiratory Muscle Strength is Indicated by Maximal Inspiratory Pressure (PImax)|The inspiratory muscle strength will be measured in the unit of cmH2O by the Respiratory Muscle Pressure Meter (Micro Direct). A higher inspiratory pressure indicates a better inspiratory breathing strength.|Baseline and 6 weeks||||cm H2O||Full Range|Mean
2662628|NCT01560871|Primary|Change From Baseline in Mean Score of Physical Component of the SF-36 Questionnaire|The SF-36 quality of life questionnaire (short form) was used. A higher score of the SF-36 questionnaire indicates a better outcome (i.e., lower disability). The range of overall score on the SF-36 questionnaire is from 0 to 100.|Baseline and 6 weeks||||score on a scale||Full Range|Mean
2662629|NCT01560871|Primary|Change From Baseline in Mean Minnesota Living With Heart Failure Questionnaire Score|This questionnaire includes 21 questions which ask how much the heart condition affected the patient's life during the past month. Each question has 5 optional answers with the scores ranging from 0 to 5. A higher score indicates a worse outcome. The minimum overall score of the questionnaire is 0 and the maximum score is 105. A higher overall score on the Minnesota Living with Heart Failure Questionnaire indicates a worse outcome.|Baseline and 6 weeks||||score on a scale||Full Range|Mean
2662630|NCT01560819|Primary|Clinical Response|Clinical response (i.e. improvement in Pediatric Ulcerative Colitis Activity Index (PUCAI) score by greater than or equal to 15 points from baseline) at 4 weeks following GMT treatment|4 weeks following GMT Treatment|One participant showed intolerance to the treatment (immediate leaking of enema) and was not included in post-treatment disease activity evaluation.|||Participants|||Number
2662631|NCT01560780|Secondary|Normalized Total Target Saphenous Vein Graft Atheroma Volume, as Assessed by Intravascular Ultrasonography|"On IVUS images, atheroma volume was defined as the sum of the cross-sectional areas between the leading edges of the lumen and external elastic membrane. Total Target SVG atheroma volume was calculated as:~∑(EEM area - Lumen area).~Normalized atheroma volume represents the atheroma volume corrected for pullback length, and this parameter was calculated as:~∑(EEM area - Lumen area)/number of frames in pullback"|12 months|"In the prasugrel arm, 29 of the 42 patients underwent SVG angiography at 12 months (2 died, 11 did not want to undergo SVG angiography). Of these, 25 had interpretable IVUS.~In the placebo arm, 30 of the 42 patients underwent SVG angiography at 12 months (1 died, 11 did not wish to undergo SVG angiography). Of these, 27 had interpretable IVUS."|||mm3/frame||Standard Deviation|Mean
2662632|NCT01560780|Secondary|Major Adverse Cardiac Events, Defined as the Composite of Death, Acute Coronary Syndrome, or Coronary Revascularization) During Follow-up|Number of patients with the composite outcome of death, acute coronary syndrome, or coronary revascularization.|12 months||||Participants|||Count of Participants
2662633|NCT01560780|Secondary|Saphenous Vein Graft Lipid Core Burden Index, as Assessed at Near-infrared Intracoronary Spectroscopy|Lipid core burden as measured by Lipid Core Burden Index on near infrared intracoronary spectroscopy imaging of saphenous vein graft. Lipid Core Burden Index is defined as the fraction of pixels within the scanned region with a probability >0.60 that a lipid core plaque is present (calculated by an algorithm developed to identify the NIRS signals associated with the molecular structure of lipids), multiplied by 1000 using EchoPlaque software (INDEC Medical Systems; Los Altos, CA) . Thus, the lipid core burden index (LCBI) is a quantitative summary metric of the probability of the presence of lipid within the scanned region, with a range of 0-1000, with higher indices indicating a higher proportion of pixels with a >0.6 probability of lipid being present in the pullback of the catheter along the length of the entire vessel.|12 months|"In the prasugrel arm, 29 of the 42 patients underwent SVG angiography at 12 months (2 died, 11 did not want to undergo SVG angiography). Of these, 12 had interpretable NIRS.~In the placebo arm, 30 of the 42 patients underwent SVG angiography at 12 months (1 died, 11 did not wish to undergo SVG angiography). Of these, 20 had interpretable NIRS."|||units on a scale||Standard Deviation|Mean
2662634|NCT01560780|Secondary|Total Target Saphenous Vein Graft Atheroma Volume, as Assessed by Intravascular Ultrasonography|Total target saphenous vein graft atheroma volume (mm3) as assessed by Intravascular ultrasound imaging in imaged saphenous vein grafts.|12 months|"In the prasugrel arm, 29 of the 42 patients underwent SVG angiography at 12 months (2 died, 11 did not want to undergo SVG angiography). Of these, 25 had interpretable IVUS.~In the placebo arm, 30 of the 42 patients underwent SVG angiography at 12 months (1 died, 11 did not wish to undergo SVG angiography). Of these, 27 had interpretable IVUS."|||mm3||Standard Deviation|Mean
2662635|NCT01560780|Secondary|Number of Patients With Angiographic Saphenous Vein Graft Failure|Number of patients with angiographic saphenous vein graft failure (defined as =75% SVG diameter stenosis in at least one saphenous vein graft)|12 months|"In the prasugrel arm, 29 of the 42 patients underwent SVG angiography at 12 months (2 died, 11 did not want to undergo SVG angiography).~In the placebo arm, 30 of the 42 patients underwent SVG angiography at 12 months (1 died, 11 did not wish to undergo SVG angiography)."|||Participants|||Count of Participants
2662636|NCT01560780|Secondary|Number of Patients With Severe Bleeding Using the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) Criteria|Number of patients with major bleeding defined by the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries criteria.|12 months||||Participants|||Count of Participants
2662637|NCT01560780|Primary|Prevalence of Intragraft Thrombus at 12-month Follow-up Optical Coherence Tomography Imaging|Number of patients with intragraft thrombus seen at 12 month follow-up by optical coherence tomography in imaged saphenous vein graft|12 months|"In the prasugrel arm, 29 of the 42 patients underwent SVG angiography at 12 months (2 died, 11 did not want to undergo SVG angiography). Of these, 25 had interpretable OCT.~In the placebo arm, 30 of the 42 patients underwent SVG angiography at 12 months (1 died, 11 did not wish to undergo SVG angiography). Of these, 28 had interpretable OCT."|||Participants|||Count of Participants
2662638|NCT01560624|Secondary|Change in World Health Organization Functional Class (WHO FC) From Baseline to Week 48|The WHO FC for PAH was assessed at Baseline prior to starting study drug, at all subsequent scheduled study visits, and every time the 6MWT was performed for purposes of assessing clinical worsening status.|Baseline to Week 48||||Participants|||Count of Participants
2662639|NCT01560624|Secondary|Change in Plasma N-Terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Week 24|Plasma NT-proBNP concentration is a useful biomarker for the severity of PAH as it is associated with changes in right heart morphology and function. NT-proBNP sample collection occurred at Baseline (prior to starting study drug), Week 12, Week 24, the first Continued Visit, and every other Continued Visit thereafter (ie, Continued Visits 3, 5, 7, etc). NT-proBNP was also assessed at the Study Drug Termination Visit. The change between Baseline and Week 24 is reported.|From Baseline to Week 24|Subjects who did not have a valid NT-proBNP measurement at Baseline or Week 24 were excluded from the analysis.|||Ratio to baseline||Standard Error|Least Squares Mean
2662640|NCT01560624|Secondary|Change in 6-Minute Walk Distance|The intent of the 6-Minute Walk Test (6MWT) is to evaluate exercise capacity associated with carrying out activities of daily living. A baseline 6MWT was performed prior to initiation of study drug on the day of randomization. 6MWTs were conducted at Weeks 4, 8, 12, 24, and every 12 weeks thereafter. The change between Baseline and Week 24 is reported.|From Baseline to Week 24||||meters||Standard Deviation|Mean
2662641|NCT01560624|Primary|Time to First Clinical Worsening Event|Clinical worsening was assessed continuously from randomization until the subject's last study visit. Clinical worsening events were defined as death (all causes), hospitalizations due to worsening pulmonary arterial hypertension (PAH), initiation of an inhaled or infused prostacyclin (PGI2) for the treatment of worsening PAH, disease progression, or unsatisfactory long-term clinical response. All clinical worsening events reported by the study sites were reviewed by the Sponsor Medical Monitors. Once a clinical worsening event occurred, it was entered in the eCRF and a narrative was submitted for review by the Sponsor's Medical Monitor within 48 hours after the event became known to the Investigator or designee. Subsequently, the narratives for subjects with the reported clinical worsening events were sent to an independent adjudication committee. The independent adjudication committee reviewed and adjudicated all clinical worsening events throughout the study.|From randomization to approximately 4 years||||weeks||Standard Deviation|Mean
2662642|NCT01560507|Secondary|Quit Success Genotype Score|"Study was terminated early due to difficulties with enrollment. No outcome measures were assessed."|After 6 month Follow-Up|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.||||||
2662643|NCT01560507|Primary|Cost-effectiveness of the Adaptive Treatment Approach to Smoking Cessation|Study was terminated early due to difficulties with enrollment. No outcome measures were assessed.|End of study drug treatment period (11-12 weeks)|||||||
2662644|NCT01560429|Primary|Anesthetic Consumption (mg)|amount of anesthetic consumed was calculated for each group over time.|4,8,12, 24 and 48 hours postoperatively||||mg||Standard Error|Mean
2662645|NCT01560429|Secondary|Worst Pain While Coughing|Worst pain on a numerical rating scale(0-10 worst) at 24 and 48 hours following thoracotomy|48 hours postoperatively|||||||
2662646|NCT01560429|Secondary|Worst Pain Scores|worst pain scores on numerical rating scale (0-10, where 10 is the worst) at 24 & 48 hours following surgery|48 hours postoperatively|||||||
2662647|NCT01560429|Primary|Local Anesthetic Consumption|Amount of anesthetic consumed (either through epidural catheter or as rescue bolus at 48 hours following thoracotomy administered either through CEA or PCEA.|48 hours postoperatively||||ug||Standard Error|Mean
2662648|NCT01560416|Secondary|Overall Survival (OS)|OS based on Kaplan-Meier is defined as the time from study entry to death or date last known alive or censored at date last known alive.|Participants were followed long-term for survival every 3 months from the end of treatment until death, lost to follow-up or up to 4 years from treatment end. Median survival follow-up was 28 months for the study cohort.|The analysis dataset is comprised of all enrolled participants.|||months||95% Confidence Interval|Median
2662649|NCT01560416|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants with measurable disease at baseline achieving complete response (CR), partial response (PR), or stable disease (SD) for 24 weeks or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria. SD needed to be a minimum 24 weeks in duration.|Disease was assessed radiographically every 2 cycles for year 1 and every 2-4 cycles thereafter on treatment. Maximum treatment duration was 41 cycles (Arm A) and 42 cycles (Arm B) which approximates 38 months.|The analysis dataset is comprised of all enrolled participants.|||percentage of participants||95% Confidence Interval|Number
2662650|NCT01560416|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with measurable disease at baseline achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was assessed radiographically every 2 cycles for year 1 and every 2-4 cycles thereafter on treatment. Maximum treatment duration was 41 cycles (Arm A) and 42 cycles (Arm B) which approximates 38 months.|The analysis dataset is comprised of all enrolled participants.|||percentage of participants||95% Confidence Interval|Number
2662651|NCT01560416|Secondary|Grade 3-4 Toxicity Rate|All grade 3-4 adverse events (AE) with treatment attribution of possibly, probably or definite based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) as reported on case report forms were counted to calculate the percentage of participants experiencing at least one treatment-related grade 3 or 4 AE of any type on treatment.|AEs were assessed every cycle on treatment (weeks 2-3 on cycle 1). Median treatment duration was 4 cycles/~4 months on each arm. Maximum treatment duration was 41 cycles (Arm A) and 42 cycles (Arm B) which approximates 38 months.||||percentage of participants|||Number
2662652|NCT01560416|Primary|Progression-Free Survival (PFS)|PFS based on Kaplan-Meier is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD are censored at the date of last disease assessment. Participants who receive non-protocol anti-cancer therapy before disease progression are censored at time of last disease assessment.|Disease was assessed radiographically every 2 cycles for year 1 and every 2-4 cycles longer-term. Participants in this study cohort were followed for survival up to 4 years from treatment end.||||months||95% Confidence Interval|Mean
2662653|NCT01560403|Primary|Summary of Treatment-emergent Adverse Events|As the primary intent of this study was to collect additional safety data, this outcomes measure will provide a summary of the treatment emergent adverse events. Based on the start date of each subject in this study and the study end date, not all subjects reached 12 months.|12 months|Safety Population|||participants|||Number
2668477|NCT01505764|Secondary|Quality of Life.|Quality of life as assessed using the FACIT-F Patient Reported Outcome assessments - percentage of change day 84-baseline|day 84|cancer cachexia patients|||percentage change||Standard Deviation|Mean
2662654|NCT01560377|Secondary|Safety of the PINPOINT System|To assess safety related outcomes of the laparoscopic left colectomies with intra-operative assessment of perfusion using the PINPOINT Endoscopic Fluorescence Imaging System for guidance.|Through hospital discharge or at 30 days post procedure, whichever is later||||Participants|||Count of Participants
2662655|NCT01560377|Primary|PINPOINT System Utility in Left Colectomy Surgery|To demonstrate the utility of intra-operative assessment of colon perfusion, using the PINPOINT System to optimize the location at which to transect the colon in laparoscopic left colectomies and to assess mucosal perfusion of the completed anastomosis following proximal anastomosis in laparoscopic left colectomy.|Day of Operation - Day 1||||Participants|||Count of Participants
2662656|NCT01560286|Secondary|Percentage of Participants With Positive Anti-PAL-PEG IgE Antibodies|Antibody positivity|Baseline, Week 24|The safety population will consist of all subjects who receive any amount of study drug throughout the study duration.|||percentage|||Number
2662657|NCT01560286|Secondary|Percentage of Participants With Positive Anti-PAL-IgE Antibodies|Antibody positivity|Baseline, Week 24|The safety population will consist of all subjects who receive any amount of study drug throughout the study duration.|||percentage|||Number
2662658|NCT01560286|Secondary|Percentage of Participants With Positive Neutralizing Antibodies [Nab]|Antibody positivity|Baseline, Week 24|The safety population will consist of all subjects who receive any amount of study drug throughout the study duration.|||percentage|||Number
2662659|NCT01560286|Secondary|Percentage of Participants With Positive Anti-PEG-IgM|Antibody positivity|Baseline, Week 24|The safety population will consist of all subjects who receive any amount of study drug throughout the study duration.|||percentage|||Number
2662660|NCT01560286|Secondary|Percentage of Participants With Positive PAL-IgM|Antibody Positivity|Baseline, Week 24|The safety population will consist of all subjects who receive any amount of study drug throughout the study duration.|||percentage|||Number
2662661|NCT01560286|Secondary|Percentage of Participants With Positive Anti-PEG IgG|Antibody Positivity|Baseline, Week 24|The safety population will consist of all subjects who receive any amount of study drug throughout the study duration.|||percentage|||Number
2662662|NCT01560286|Secondary|Trough Concentration of BMN 165|PK assessment from pre-dose blood draw.|Week 1, Week 24|The PK population will consist of all subjects who received any amount of study drug and have post-treatment plasma BMN 165 concentration measurements.|||ng/mL||Standard Deviation|Mean
2662663|NCT01560286|Secondary|Percentage of Participants With Positive Anti-PAL Immunoglobulin G [IgG]|Antibody Positivity|Baseline, Week 24|The safety population will consist of all subjects who receive any amount of study drug throughout the study duration.|||percentage|||Number
2662664|NCT01560286|Secondary|Number of Participants With Study Drug Related Adverse Events||Minimum Weekly Assessment of Injection Sites, Vital Signs and Adverse Events. Other Safety Assessments will be performed at other intervals (below):|The safety population will consist of all subjects who receive any amount of study drug throughout the study duration.|||Participants|||Count of Participants
2662665|NCT01560286|Primary|Blood Phenylalanine Concentration|"All patients will have their plasma Phenylalanine (Phe) assessed. Please note that Pharmacokinetics Sub-study was not performed, and thus no results are available."|Baseline, Week 24|The efficacy population will consist of all subjects who received any amount of study drug and have post-treatment blood Phe concentration measurements.|||umol/L||Standard Deviation|Mean
2662666|NCT01560260|Other Pre-specified|Determine the Number of Participants With Tumor Metabolic Response Correlating With Anatomic Response and Clinical Benefit.|To determine if the number of participants with tumor metabolic response correlates with anatomic response and clinical benefit.|Up to 37 weeks||||Participants|||Count of Participants
2662667|NCT01560260|Other Pre-specified|Time to Progression|Time to progression will be evaluated using cumulative incidence.|Up to 3 years||||months||Full Range|Median
2662668|NCT01560260|Secondary|Correlations Between Glucose, Insulin, Tumor Tissue and Blood Biomarkers With FDG-PET Metabolic Response.|To investigate correlations between glucose, insulin, tumor tissue and blood biomarkers with FDG-PET metabolic response.|Up to 37 weeks|Data was not collected in correlation to FDG-PET response results.||||||
2662669|NCT01560260|Secondary|Changes in Tumor Metabolism by FDG-PET Qualitatively and Semi-quantitatively With Standard Uptake Value (SUV)|"To measure changes in tumor metabolism by FDG-PET qualitatively and semi-quantitatively with SUV from baseline to first CT response evaluation and correlate the findings with size changes as defined by conventional cross-sectional imaging scans.~SUVmax determined by: SUVmax = [VOI activity (mCi/ml) * body wt (g)]/injected dose (mCi) SUVpeak determined by identifying the hottest cubic centimeter within a VOI centered on the lesion with the highest FDG."|Baseline and 8 weeks||||Standard uptake value (SUV)||Full Range|Mean
2662670|NCT01560260|Secondary|Number of Participants With Metabolic Response to Linsitinib Using FDG-PET.|Evaluate the number of participants with metabolic response to OSI-906 using fluorodeoxyglucose positron emission tomography (FDG-PET). Evaluation of metabolic response to linsitinib based on two criteria (EORTC and PERCIST).|Up to 37 weeks||||Participants|||Count of Participants
2662671|NCT01560260|Secondary|Patterns of Protein Expression in Serum and Tumor Tissues as Predictors of Response and PFS|To explore patterns of protein expression in serum and tumor tissues as predictors of response and progression-free survival in advanced WT GIST treated with OSI-906. All Insulin Growth Factor Receptor (IGFR) and phosphorylated AKT (pAKT) evaluation was performed in a blinded manner. Distribution and intensity of positive tumor cell staining was assessed for these markers. Loss of succinate dehydrogenase complex flavoprotein subunit A (SDHA) protein expression has been correlated with the presence of a mutation in SDHA. Loss of succinate dehydrogenase complex iron sulfur subunit B (SDHB) protein expression occurs from bi-allelic inactivation of any of the succinate dehydrogenase (SDH) subunit genes. Loss of expression of one member of the complex alters the structure or production of SDH proteins such that the complex is no longer able to form. This results in elevated intracellular levels of succinate as well as loss of demethylase activity.|Up to 37 weeks|Depending on the patient samples available, the available samples varied from 17 to 14.|||Participants|||Count of Participants
2662672|NCT01560260|Secondary|Tolerability and Adverse Event Profile of Linsitinib|To determine the tolerability and adverse event profile of OSI-906 in patients with advanced GIST.|Up to 37 weeks|285 Adverse Events reported during the study.|||Adverse Events|Adverse Events||Count of Units
2662678|NCT01560260|Primary|Number of Participants With Complete Response or Partial Response Using Response Evaluation Criteria in Solid Tumors Guideline Version 1.1|Determine the response rate, Complete Response (CR) or Partial Response (PR), to treatment with linsitinib (OSI-906) in patients with advanced wild-type (WT) gastrointestional stromal tumor (GIST) as determined by RECIST 1.1.|At 6 months|0 out of 20 patients had a response|||participants|||Number
2662679|NCT01560234|Secondary|Statistical Assessment of CXCL10 Ratio-to-baseline- Sputum|Summarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix|Baseline, 24 Hours.|Pharmacodynamic Population Set|||ratio||95% Confidence Interval|Least Squares Mean
2662680|NCT01560234|Primary|Summary for Lymphocytes Laboratory Results||Baseline, Day 1, Day 2, Day 3, and Follow up (up to Day 13)|Safety Analysis Set|||cells*10^9/L||Standard Deviation|Mean
2662681|NCT01560234|Secondary|Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma|Smmarize the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix|Baseline, 48 Hours|Pharmacodynamic Population Set|||ratio||95% Confidence Interval|Least Squares Mean
2662682|NCT01560234|Secondary|Statistical Assessment of CXCL10 Ratio-to-baseline - Plasma|Smmarizes the statistical assessment comparing active CXCL10 ratio to baseline to placebo at each dose level, sampling time, and matrix|Baseline, 24 Hours.|Pharmacodynamic Population Set|||ratio||95% Confidence Interval|Least Squares Mean
2662683|NCT01560234|Secondary|Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - Cmax (Nmol/L)||On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h|Pharmacokinetic Population|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2662684|NCT01560234|Secondary|Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC(0-t) (Nmol*h/L)||On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h|Pharmacokinetic Population|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2662685|NCT01560234|Secondary|Summary (Geometric Mean and GCV%) of Pharmacokinetic Parameters of Total AZ12432045 - AUC (Nmol*h/L)||On Day 1 at 0min, 2min, 5min, 10min, 20min, 30min, 45min, 60min, 90min, 2h, 4h, 6h, 8h, 12h, 24h and 48h|Pharmacokinetic Population|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2662686|NCT01560234|Primary|Adverse Events|Summary of number of subjects who had at least one adverse event|Screening up to Day 13|Safety Analysis Set|||participants|||Number
2662687|NCT01560143|Primary|Single-dose Serum AUC of Tigecycline Between Time 0 and 96 Hours|The AUC is the area under the concentration time curve in serum measured in the unit of concentration in milligram of tigeycline per liter of plasma multiplied by the time interval in hours (hour*mg/L)|4 days (96 hours)||||hour*mg/L||Standard Deviation|Mean
2662688|NCT01559948|Secondary|Percent Change of Muscle Thickness for Internal Oblique|The percent change of muscle thickness of the Internal Oblique will be assessed using ultrasound imaging. The deep abdominal muscles will be imaged in brightness mode (b-mode) using the SonoSite M-Turbo Ultrasound System. A 2-5 MHz broad spectrum curvilinear transducer will be used to obtain the images. Images were saved for offline analysis using ImageJ software. The muscle thickness for was determined by the linear distance between the upper and lower fascial lines at the midpoint of the muscle as measured by ImageJ Software. The percent change of muscle thickness was calculated using the following formula: (contracted thickness - resting thickness)/ resting thickness x 100%.|Baseline, 4 weeks, 12 weeks||||percentage change||Standard Deviation|Mean
2662689|NCT01559948|Secondary|Change in Global Rating of Change (GROC) Scale|"The GROC scale will be used to assess the participants' overall perception of improvement since the beginning the interventions. This is a scale ranging from -7 (a very great deal worse) to 0 (about the same) to +7 (a very great deal better)."|4 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2662690|NCT01559948|Secondary|Percent Change of Muscle Thickness for the Transverse Abdominis (TrA)|The percent change of muscle thickness of the TrA will be assessed using ultrasound imaging. The deep abdominal muscles will be imaged in brightness mode (b-mode) using the SonoSite M-Turbo Ultrasound System. A 2-5 MHz broad spectrum curvilinear transducer will be used to obtain the images. Images were saved for offline analysis using ImageJ software. The muscle thickness for each muscle was determined by the linear distance between the upper and lower fascial lines at the midpoint of the muscle as measured by ImageJ Software. The percent change of muscle thickness was calculated using the following formula: (contracted thickness - resting thickness)/ resting thickness x 100%.|Baseline, 4 weeks, 12 weeks||||percentage change||Standard Deviation|Mean
2662691|NCT01559948|Secondary|Numeric Pain Rating Scale (NPRS)|"The numeric pain rating scale (NPRS) is an 11-point scale with 0 representing no pain and 10 representing worst imaginable pain. This scale will be used to assess pain intensity."|Baseline, 4 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2662692|NCT01559948|Primary|Oswestry Low Back Pain Questionnaire|The Modified Oswestry Back Pain Questionnaire(OSW) will be used to determine Low back pain-related disability. The OSW consists of 10 items assessing different aspects of pain and function related to LBP. Each item is scored 0-5. The item scores are summed and multiplied by 2 to get the total disability score. The total score reported can range from 0-100 with 0 representing no disability and higher scores representing greater disability.|Baseline, 4 weeks, 12 weeks||||units on a scale||Standard Deviation|Mean
2662693|NCT01559935|Secondary|Stem Cells Collection|At the end of the Car Phase, all participants underwent stem cell collection.|At the end of the Car Phase, prior to the start of the BiRD Phase, on average after 162 days.|58 participants reached the end of the Car Phase. From those 58 participants, 52 were collected, 5 participants declined stem cell collection and 1 participant's results were not evaluable.|||Number of stem cells collected per Kg||Standard Deviation|Mean
2662694|NCT01559935|Secondary|Progression Free Survival|Progression was defined using the IMWG criteria.|From start of study drug until first incidence of progression, up to 1222 days.|21 participants had an incidence of progression.|||months||Full Range|Median
2662695|NCT01559935|Secondary|MRD Negativity Following CarBiRD Regimen|"Minimal Residual Disease (MRD) was assessed for all participants as soon as they achieved CR/sCR, regardless of what phase they were on.~MRD negativity is defined as the complete absence of plasma cells on bone marrow biopsy.~MRD positivity is defined as the presence of residual plasma cells (<5%) on bone marrow biopsy.~The IMWG criteria were used to determine CR and sCR."|From start of study up to Revlimid Maintenance Cycle 4.|28 participants achieved CR or sCR.|||Participants|||Count of Participants
2662696|NCT01559935|Secondary|Event Free Survival|an event is defined by coming off protocol for any reason, including progression of disease, lack of disease response, regimen intolerability, withdrawal of consent or death.|From date of study enrollment until the date of removal of study due to progression of disease, toxicity or withdrawal of consent, up to 1222 days.|44 participants analyzed out of the 72 participants initially enrolled in the study. 28 participants are active and therefore have not experienced any events leading to removal from study.|||Days||Full Range|Median
2662697|NCT01559935|Primary|Response to Car-BiRD Treatment.|"The best response for all patients who had at least one dose of drug was measured.~Response categories:~Stringent Complete Response (sCR), Complete Remission(CR), Very Good Partial Remission(VGPR), Partial Remission (PR), Progressive Disease (PD), Stable Disease (SD).~The response is evaluated based on the IMWG criteria."|From baseline to best response, up to 116 weeks.||||Participants|||Count of Participants
2662698|NCT01559922|Primary|ASRS Responder Rate at 6 Months|"Subject considered to be a responder if at least 50% of treated scars demonstrate an ASRS improvement of ≥ 2-point (Blinded Evaluator assessment)."|6 months post-treatment|Full Analysis Population included only subjects that passed screening|||percentage of participants||95% Confidence Interval|Number
2662699|NCT01559857|Secondary|Change in HDRS-21: From Baseline to 12 Weeks|The HDRS-21 was administered at baseline and at the end of 12 weeks, and the mean difference between the two time points was calculated. The HDRS-21 is scored on a scale from 0 to 21, where 0 is the lowest level of depression severity and 21 is the highest level of depression severity.|12 weeks||||units on a scale||Standard Deviation|Mean
2662700|NCT01559857|Secondary|Fasting Insulin Measurements at Baseline|The fasting plasma insulin measurements taken at baseline are shown in the data table below.|Baseline||||uIU/mL||Standard Deviation|Mean
2662701|NCT01559857|Primary|Hamilton Depression Rating Scale at Baseline|The HDRS-21 was used to screen for unremitted depression. The HDRS-21 is scored on a scale from 0 to 21, where 0 is the lowest level of depression severity and 21 is the highest level of depression severity. Unremitted depression is characterized by a score of ≥7. The HDRS-21 scores at baseline are shown in the data table below.|Baseline||||units on a scale||Standard Deviation|Mean
2662702|NCT01559844|Primary|Number of Participants Who Died|"Treatment-emergent deaths were those that occurred while taking study drug or to the minimum of 1) date of transplantation, 2) retreatment 1st dose date, or 3) last dose date + 30 days.~Only those participants who underwent liver transplantation were analyzed for death post-transplantation."|Up to 48 weeks following transplant|Safety Analysis Set|||participants|||Number
2662703|NCT01559844|Secondary|Proportion of Participants With Virologic Failure Prior to Transplant|"Virologic failure (VF) in the pretransplant phase was defined by:~Breakthrough (HCV RNA ≥ 25 IU/ml after having previously had HCV RNA < 25 IU/ml, while on treatment)~Rebound (breakthrough or > 1 log10 IU/ml increase in HCV RNA from nadir while on treatment)~Non-response (HCV RNA ≥ 25 IU/ml through 8 weeks of treatment)~Pre-transplant relapse (HCV RNA ≥ 25 IU/ml during the Pre-Transplant off-treatment follow-up period after having achieved HCV RNA < 25 IU/ml at last observed HCV RNA on treatment)"|Up to 48 weeks prior to transplant|On-treatment VF: Full Analysis Set. Posttreatment/Pretransplant VF - 24 Weeks or 48 Weeks: Participants who completed 24 or 48 weeks of treatment and had an observed or imputed Week 4 posttreatment follow-up HCV RNA value relapsed during posttreatment follow-up were analyzed.|||percentage of participants|||Number
2662704|NCT01559844|Secondary|HCV RNA and Change From Baseline in HCV RNA Through Week 8||Up to 8 weeks prior to transplant|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2662705|NCT01559844|Secondary|Percentage of Participants With HCV RNA < LLOQ (ie, 25 mL/IU) During Treatment Through Week 48||Up to 48 weeks prior to transplant|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2662706|NCT01559844|Secondary|Percentage of Participants With Posttransplant Virologic Response (pTVR) Through Posttransplant Week 48|pTVR was defined as HCV RNA < the lower limit of quantification (LLOQ, ie, 25 mL/IU) at the relevant time point after transplant.|Up to 48 weeks following transplant|Participants in the Full Analysis Set who underwent liver transplantation and who had ≥ 12 weeks treatment and HCV RNA < LLOQ at last measurement prior to transplant were analyzed.|||percentage of participants|||Number
2662707|NCT01559844|Primary|Percentage of Participants With Graft Loss Following Transplant||Up to 48 weeks following transplant|Participants in the Safety Analysis Set who underwent liver transplantation were analyzed.|||percentage of participants|||Number
2662708|NCT01559844|Primary|Percentage of Participants Experiencing Any Adverse Event Leading to Permanent Discontinuation of Sofosbuvir Prior to Receiving Transplant||Up to 48 weeks prior to transplant|Safety Analysis Set|||percentage of participants|||Number
2662709|NCT01559844|Primary|Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12|pTVR was defined as HCV RNA < the lower limit of quantification (LLOQ, ie, 25 mL/IU) at Week 12 after transplant.|Posttransplant Week 12|Participants in the Full Analysis Set (enrolled and received at least 1 dose of study drug) who underwent liver transplantation, and who had HCV RNA < LLOQ at last measurement prior to transplant were analyzed.|||percentage of participants|||Number
2662710|NCT01559675|Primary|Orthostatic Hypotension||Postoperative Day 1||||participants|||Number
2662711|NCT01559649|Secondary|Reliability of Nurse Interpretation of Each Screening Items and the Valid Combination of Items|Determine if stroke-ward staff nurses can make reliable inter-rater judgments of swallowing (e.g. cough after swallow, wet voice after swallow) and nonswallowing features (e.g. decreased volitional cough, dysarthria) historically used by SLPs to make judgments of aspiration.|3 years||||kappa||95% Confidence Interval|Number
2662712|NCT01559649|Secondary|Average Accuracy Rate for Nurse Administration for All Screening Procedures|Determine if current stroke-ward staff nurses can accurately administer screening items.|3 years||||percentage of accuracy||Full Range|Mean
2662713|NCT01559649|Primary|Negative Predictive Value of Screening Items|Identify the combination of screenings items that provide the highest level of negative predictive value in the identification of aspiration risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke.|3 years|Nurses were not assessed for this outcome measure|||percentage of agreement||95% Confidence Interval|Number
2668478|NCT01505764|Secondary|Body Weight.|percent change from day 84-baseline|day 84|cancer cachexia patients|||percentage change||Standard Deviation|Mean
2662714|NCT01559649|Primary|Specificity of Screening Items|Identify the combination of screenings items that provide the highest level of specificity in the identification of aspiration risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke.|3 years|Nurses were not assessed for this outcome measure|||percentage of agreement||95% Confidence Interval|Number
2662715|NCT01559649|Primary|Sensitivity of Screening Items|Identify the combination of screenings items that provide the highest level of sensitivity in the identification of aspiration risk as measured by a videofluoroscopic swallow study (VFSS) in individuals admitted with suspected stroke.|3 years|Nurses were not assessed for this outcome measure|||percentage of agreement||95% Confidence Interval|Number
2662716|NCT01559506|Primary|CFU Density|Colony-forming unit density at incision site (CFU/m3)|Surgical case CFU density will be determined at up to 1 month from completion of surgical cases||||CFU/m^3||95% Confidence Interval|Mean
2662717|NCT01559454|Secondary|Treatment Retention|Number of participants that completed the study protocol|6 months||||participants|||Number
2662718|NCT01559454|Secondary|Depression|"Depression will be assessed using the Beck Depression Inventory, a 63 point scale with 0 being none and 63 being severe."|at 6 months||||units on a BDI scale||Standard Deviation|Mean
2662719|NCT01559454|Secondary|Functioning|"Functioning will be assessed using the Visual Analogue Scale (VAS) with 0 being no limits and 100 being bedridden."|at 6 months||||units on a VAS scale||Standard Deviation|Mean
2662720|NCT01559454|Secondary|Cravings|Cravings will be assessed using the Visual Analogue Scale (VAS) with 0 being no cravings and 100 being worse possible cravings|at 6 months||||units on a VAS scale||Standard Deviation|Mean
2662721|NCT01559454|Secondary|Illicit Drug Use|Illicit opioid use will be measured by self-report and confirmed with urine toxicology.|6 months|19 participants were enrolled in the study, and 10 were available at the 6-month follow-up|||participants|||Number
2662722|NCT01559454|Primary|Analgesia|Pain severity will be measured using the Visual Analogue Scale (VAS) which has a range of 0-100 with 0 being no pain and 100 being worse possible pain.|6 months|19 participants were enrolled in the study, and 10 were available for the 6-month follow-up.|||units on a VAS scale||Standard Deviation|Mean
2662723|NCT01559389|Secondary|Change in Overall Sexual Satisfaction Among Healthy Male Partners|Healthy male partners of female participants complete the Golombok Rust Inventory of Sexual Satisfaction (GRISS) survey. For this outcome, their baseline score is subtracted from their follow-up score which is collected after their female partner completes approximately 12-16 weeks of solifenacin treatment for UUI symptoms. This change score is compared between male partners of female participants who respond to solifenacin versus male partners of female participants who do not respond to solifenacin. The GRISS is a 28-item self-administered questionnaire that assess the quality of the sexual relationship of a heterosexual couple. Scores range from 0 to 10 with higher scores indicating greater sexual dysfunction.|Baseline and 12-16 weeks|The analysis population comprises the 49 male partners of the female participants who received up to 16 weeks of solifenacin for the treatment of UUI symptoms|||score on a scale||Inter-Quartile Range|Median
2662724|NCT01559389|Secondary|Change in Overall Sexual Satisfaction Among Females|Females presenting with UUI complete the Golombok Rust Inventory of Sexual Satisfaction (GRISS) at baseline (0 weeks) and after 12-16 weeks of treatment with solifenacin. For this outcome, the baseline score is subtracted from the follow-up score and this change score is compared between those who respond and do not respond to treatment with solifenacin. The GRISS is a 28-item self-administered questionnaire that assess the quality of the sexual relationship of a heterosexual couple. Scores range from 0 to 10 with higher scores indicating greater sexual dysfunction.|Baseline and 12-16 weeks|The analysis population comprises 49 female participants who received up to 16 weeks of solifenacin for the treatment of UUI symptoms|||score on a scale||Inter-Quartile Range|Median
2662725|NCT01559389|Primary|Baseline Sexual Satisfaction Between Matched Female and Male Partners|Prior to beginning treatment with solifenacin, females presenting with UUI complete the Golombok Rust Inventory of Sexual Satisfaction (GRISS). Their male partners also complete the GRISS at the baseline visit. The GRISS is a 28-item self-administered questionnaire that assess the quality of the sexual relationship of a heterosexual couple. Scores range from 0 to 10 with higher scores indicating greater sexual dysfunction.|0 Weeks||||score on a scale||Standard Deviation|Mean
2662726|NCT01559311|Primary|LVESV|Left ventricular end-systolic volume (LVESV) for assessment of LV remodeling|12 months|From Feb 2013 to Dec 2014, only 98 subjects out of 177 target enrolments were recruited into the study.|||ml||Standard Deviation|Mean
2662727|NCT01559311|Primary|LVEF|Left Ventricular Ejection Fraction (LVEF) for assessment of Left ventricular (LV) systolic function|12 months|From Feb 2013 to Dec 2014, only 98 subjects out of 177 target enrolments were recruited into the study.|||% LVEF||Standard Deviation|Mean
2662728|NCT01559129|Secondary|Pharmacokinetic Parameters of Pomalidomide in Plasma|Pharmacokinetic (PK) analyses were not conducted as there were too few participants with available data.|Day 1 and week 4 pre-dose and up to 24 hours post-dose.|PK analyses were not conducted as there were too few participants with available data. No data was analyzed.||||||
2662729|NCT01559129|Secondary|Oxygen Saturation Over Time|Oxygen saturation was measured by pulse oximetry.|Baseline and Weeks 12, 24, 52 (or at the Treatment Phase Early Termination visit), 64, 76, and 156 (or the Extension Phase Early Termination visit).|FAS participants with a value at each time point.|||percent saturation||Standard Deviation|Mean
2662730|NCT01559129|Secondary|Change From Baseline in Dyspnea Magnitude of Effort at Week 156/Early Termination|The Transition Dyspnea Index (TDI) provides interview-based measurements of breathlessness related to activities of daily living. The TDI is an evaluative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) to measure changes from a baseline state. At Baseline magnitude of task was assessed on a scale from Grade 0 (becomes short of breath at rest, while sitting or lying) to Grade 4 (becomes short of breath only with greatest imaginable effort). Changes in dyspnea magnitude of task were assessed on a scale from Major Deterioration (severe decrease in effort from Baseline to avoid shortness of breath, activities take 50-100% longer to complete) to Major Improvement (able to do things with much greater effort than previously with few, if any, pauses). Further impairment for other reasons includes participants with reduced exertion capacity for reasons other than shortness of breath.|Week 156 or at the Extension Phase Early Termination visit|FAS participants with available data|||Participants|||Number
2662731|NCT01559129|Secondary|Change From Baseline in Dyspnea Magnitude of Effort at Week 76|The Transition Dyspnea Index (TDI) provides interview-based measurements of breathlessness related to activities of daily living. The TDI is an evaluative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) to measure changes from a baseline state. At Baseline magnitude of task was assessed on a scale from Grade 0 (becomes short of breath at rest, while sitting or lying) to Grade 4 (becomes short of breath only with greatest imaginable effort). Changes in dyspnea magnitude of task were assessed on a scale from Major Deterioration (severe decrease in effort from Baseline to avoid shortness of breath, activities take 50-100% longer to complete) to Major Improvement (able to do things with much greater effort than previously with few, if any, pauses). Further impairment for other reasons includes participants with reduced exertion capacity for reasons other than shortness of breath.|Week 76|FAS participants with available data|||Participants|||Number
2662732|NCT01559129|Secondary|Change From Baseline in Dyspnea Magnitude of Effort at Week 64|The Transition Dyspnea Index (TDI) provides interview-based measurements of breathlessness related to activities of daily living. The TDI is an evaluative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) to measure changes from a baseline state. At Baseline magnitude of task was assessed on a scale from Grade 0 (becomes short of breath at rest, while sitting or lying) to Grade 4 (becomes short of breath only with greatest imaginable effort). Changes in dyspnea magnitude of task were assessed on a scale from Major Deterioration (severe decrease in effort from Baseline to avoid shortness of breath, activities take 50-100% longer to complete) to Major Improvement (able to do things with much greater effort than previously with few, if any, pauses). Further impairment for other reasons includes participants with reduced exertion capacity for reasons other than shortness of breath.|Week 64|FAS participants with available data|||Participants|||Number
2662733|NCT01559129|Secondary|Change From Baseline in Dyspnea Magnitude of Effort at Week 52/Early Termination|The Transition Dyspnea Index (TDI) provides interview-based measurements of breathlessness related to activities of daily living. The TDI is an evaluative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) to measure changes from a baseline state. At Baseline magnitude of task was assessed on a scale from Grade 0 (becomes short of breath at rest, while sitting or lying) to Grade 4 (becomes short of breath only with greatest imaginable effort). Changes in dyspnea magnitude of task were assessed on a scale from Major Deterioration (severe decrease in effort from Baseline to avoid shortness of breath, activities take 50-100% longer to complete) to Major Improvement (able to do things with much greater effort than previously with few, if any, pauses). Further impairment for other reasons includes participants with reduced exertion capacity for reasons other than shortness of breath.|Week 52 or at the Treatment Phase Early Termination visit|FAS participants with available data|||Participants|||Number
2662734|NCT01559129|Secondary|Change From Baseline in Dyspnea Magnitude of Effort at Week 24|The Transition Dyspnea Index (TDI) provides interview-based measurements of breathlessness related to activities of daily living. The TDI is an evaluative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) to measure changes from a baseline state. At Baseline magnitude of task was assessed on a scale from Grade 0 (becomes short of breath at rest, while sitting or lying) to Grade 4 (becomes short of breath only with greatest imaginable effort). Changes in dyspnea magnitude of task were assessed on a scale from Major Deterioration (severe decrease in effort from Baseline to avoid shortness of breath, activities take 50-100% longer to complete) to Major Improvement (able to do things with much greater effort than previously with few, if any, pauses). Further impairment for other reasons includes participants with reduced exertion capacity for reasons other than shortness of breath.|Week 24|FAS participants with available data|||Participants|||Number
2662735|NCT01559129|Secondary|Change From Baseline in Dyspnea Magnitude of Effort at Week 12|The Transition Dyspnea Index (TDI) provides interview-based measurements of breathlessness related to activities of daily living. The TDI is an evaluative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) to measure changes from a baseline state. At Baseline magnitude of task was assessed on a scale from Grade 0 (becomes short of breath at rest, while sitting or lying) to Grade 4 (becomes short of breath only with greatest imaginable effort). Changes in dyspnea magnitude of task were assessed on a scale from Major Deterioration (severe decrease in effort from Baseline to avoid shortness of breath, activities take 50-100% longer to complete) to Major Improvement (able to do things with much greater effort than previously with few, if any, pauses). Further impairment for other reasons includes participants with reduced exertion capacity for reasons other than shortness of breath.|Week 12|FAS participants with available data|||Participants|||Number
2662736|NCT01559129|Secondary|Change From Baseline in Dyspnea Magnitude of Task at Week 156/Early Termination|The Transition Dyspnea Index (TDI) provides interview-based measurements of breathlessness related to activities of daily living. The TDI is an evaluative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) to measure changes from a baseline state. At Baseline magnitude of task was assessed on a scale from Grade 0 (becomes short of breath at rest, while sitting or lying) to Grade 4 (becomes short of breath only with extraordinary activity such as running or carry very heavy loads). Changes in dyspnea magnitude of task were assessed on a scale from Major Deterioration (deteriorated ≥ 2 grades from Baseline) to Major Improvement (Improved ≥ 2 grades from Baseline). Further impairment for other reasons includes participants with reduced exertion capacity for reasons other than shortness of breath, for example musculoskeletal problems or chest pain.|Week 156 or the Extension Phase Early Termination visit|FAS participants with available data|||Participants|||Number
2662759|NCT01559129|Primary|Change From Baseline in the Modified Rodnan Skin Score (mRSS) at Week 52/Early Termination|Improvement in skin thickening is associated with improved survival and may be useful as a surrogate measurement in clinical studies. The mRSS is an assessment tool which is used to evaluate the extent and severity of the skin thickening associated with systemic sclerosis (SSc). Seventeen body areas were evaluated on a 4-point scale (0 [normal], 1 [mild], 2 [moderate]), or 3 [severe]). The total score, which is the sum of the 17 individual body assessments, can range from 0 to 51.|Baseline and Week 52 (or the Treatment Phase Early Termination visit)|FAS participants with a Baseline value and a post-baseline value at Week 52 or Early Termination|||units on a scale||Standard Deviation|Mean
2662737|NCT01559129|Secondary|Change From Baseline in Dyspnea Magnitude of Task at Week 76|The Transition Dyspnea Index (TDI) provides interview-based measurements of breathlessness related to activities of daily living. The TDI is an evaluative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) to measure changes from a baseline state. At Baseline magnitude of task was assessed on a scale from Grade 0 (becomes short of breath at rest, while sitting or lying) to Grade 4 (becomes short of breath only with extraordinary activity such as running or carrying very heavy loads). Changes in dyspnea magnitude of task were assessed on a scale from Major Deterioration (deteriorated ≥ 2 grades from Baseline) to Major Improvement (Improved ≥ 2 grades from Baseline). Further impairment for other reasons includes participants with reduced exertion capacity for reasons other than shortness of breath, for example musculoskeletal problems or chest pain.|Week 76|FAS participants with available data|||Participants|||Number
2662738|NCT01559129|Secondary|Change From Baseline in Dyspnea Magnitude of Task at Week 64|The Transition Dyspnea Index (TDI) provides interview-based measurements of breathlessness related to activities of daily living. The TDI is an evaluative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) to measure changes from a baseline state. At Baseline magnitude of task was assessed on a scale from Grade 0 (becomes short of breath at rest, while sitting or lying) to Grade 4 (becomes short of breath only with extraordinary activity such as running or carrying very heavy loads). Changes in dyspnea magnitude of task were assessed on a scale from Major Deterioration (deteriorated ≥ 2 grades from Baseline) to Major Improvement (Improved ≥ 2 grades from Baseline). Further impairment for other reasons includes participants with reduced exertion capacity for reasons other than shortness of breath, for example musculoskeletal problems or chest pain.|Week 64|FAS participants with available data|||Participants|||Number
2662739|NCT01559129|Secondary|Change From Baseline in Dyspnea Magnitude of Task at Week 52/Early Termination|The Transition Dyspnea Index (TDI) provides interview-based measurements of breathlessness related to activities of daily living. The TDI is an evaluative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) to measure changes from a baseline state. At Baseline magnitude of task was assessed on a scale from Grade 0 (becomes short of breath at rest, while sitting or lying) to Grade 4 (becomes short of breath only with extraordinary activity such as running or carrying very heavy loads). Changes in dyspnea magnitude of task were assessed on a scale from Major Deterioration (deteriorated ≥ 2 grades from Baseline) to Major Improvement (Improved ≥ 2 grades from Baseline). Further impairment for other reasons includes participants with reduced exertion capacity for reasons other than shortness of breath, for example musculoskeletal problems or chest pain.|Week 52 or at the Treatment Phase Early Termination visit|FAS participants with available data|||Participants|||Number
2662740|NCT01559129|Secondary|Change From Baseline in Dyspnea Magnitude of Task at Week 24|The Transition Dyspnea Index (TDI) provides interview-based measurements of breathlessness related to activities of daily living. The TDI is an evaluative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) to measure changes from a baseline state. At Baseline magnitude of task was assessed on a scale from Grade 0 (becomes short of breath at rest, while sitting or lying) to Grade 4 (becomes short of breath only with extraordinary activity such as running or carrying very heavy loads). Changes in dyspnea magnitude of task were assessed on a scale from Major Deterioration (deteriorated ≥ 2 grades from Baseline) to Major Improvement (Improved ≥ 2 grades from Baseline). Further impairment for other reasons includes participants with reduced exertion capacity for reasons other than shortness of breath, for example musculoskeletal problems or chest pain.|Week 24|FAS participants with available data|||Participants|||Number
2662741|NCT01559129|Secondary|Change From Baseline in Dyspnea Magnitude of Task at Week 12|The Transition Dyspnea Index (TDI) provides interview-based measurements of breathlessness related to activities of daily living. The TDI is an evaluative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) to measure changes from a baseline state. At Baseline magnitude of task was assessed on a scale from Grade 0 (becomes short of breath at rest, while sitting or lying) to Grade 4 (becomes short of breath only with extraordinary activity such as running or carrying very heavy loads). Changes in dyspnea magnitude of task were assessed on a scale from Major Deterioration (deteriorated ≥ 2 grades from Baseline) to Major Improvement (Improved ≥ 2 grades from Baseline). Further impairment for other reasons includes participants with reduced exertion capacity for reasons other than shortness of breath, for example musculoskeletal problems or chest pain.|Week 12|FAS participants with available data|||Participants|||Number
2662742|NCT01559129|Secondary|Change From Baseline in Dyspnea Functional Impairment at Week 156/Early Termination|The Transition Dyspnea Index (TDI) provides interview-based measurements of breathlessness related to activities of daily living. The TDI is an evaluative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) to measure changes from a baseline state. Changes in dyspnea functional impairment were assessed on a scale from Major Deterioration (formerly working but had to stop working and abandoned usual activities due to shortness of breath) to Major Improvement (able to return to work at former pace and return to full activities with only mild restriction due to improvement of shortness of breath). Further impairment for other reasons includes participants who gave up or reduced work or other activities for reasons other than shortness of breath.|Week 156 or the Extension Phase Early Termination visit|FAS participants with available data|||Participants|||Number
2662743|NCT01559129|Secondary|Change From Baseline in Dyspnea Functional Impairment at Week 76|The Transition Dyspnea Index (TDI) provides interview-based measurements of breathlessness related to activities of daily living. The TDI is an evaluative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) to measure changes from a baseline state. Changes in dyspnea functional impairment were assessed on a scale from Major Deterioration (formerly working but had to stop working and abandoned usual activities due to shortness of breath) to Major Improvement (able to return to work at former pace and return to full activities with only mild restriction due to improvement of shortness of breath). Further impairment for other reasons includes participants who gave up or reduced work or other activities for reasons other than shortness of breath.|Week 76|FAS participants with available data|||Participants|||Number
2662744|NCT01559129|Secondary|Change From Baseline in Dyspnea Functional Impairment at Week 64|The Transition Dyspnea Index (TDI) provides interview-based measurements of breathlessness related to activities of daily living. The TDI is an evaluative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) to measure changes from a baseline state. Changes in dyspnea functional impairment were assessed on a scale from Major Deterioration (formerly working but had to stop working and abandoned usual activities due to shortness of breath) to Major Improvement (able to return to work at former pace and return to full activities with only mild restriction due to improvement of shortness of breath). Further impairment for other reasons includes participants who gave up or reduced work or other activities for reasons other than shortness of breath.|Week 64|FAS participants with available data|||Participants|||Number
2662745|NCT01559129|Secondary|Change From Baseline in Dyspnea Functional Impairment at Week 52/Early Termination|The Transition Dyspnea Index (TDI) provides interview-based measurements of breathlessness related to activities of daily living. The TDI is an evaluative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) to measure changes from a baseline state. Changes in dyspnea functional impairment were assessed on a scale from Major Deterioration (formerly working but had to stop working and abandoned usual activities due to shortness of breath) to Major Improvement (able to return to work at former pace and return to full activities with only mild restriction due to improvement of shortness of breath). Further impairment for other reasons includes participants who gave up or reduced work or other activities for reasons other than shortness of breath.|Week 52 or at the Treatment Phase Early Termination visit|FAS participants with available data|||Participants|||Number
2662746|NCT01559129|Secondary|Change From Baseline in Dyspnea Functional Impairment at Week 24|The Transition Dyspnea Index (TDI) provides interview-based measurements of breathlessness related to activities of daily living. The TDI is an evaluative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) to measure changes from a baseline state. Changes in dyspnea functional impairment were assessed on a scale from Major Deterioration (formerly working but had to stop working and abandoned usual activities due to shortness of breath) to Major Improvement (able to return to work at former pace and return to full activities with only mild restriction due to improvement of shortness of breath). Further impairment for other reasons includes participants who gave up or reduced work or other activities for reasons other than shortness of breath.|Week 24|FAS participants with available data|||Participants|||Number
2662747|NCT01559129|Secondary|Change From Baseline in Dyspnea Functional Impairment at Week 12|The Transition Dyspnea Index (TDI) provides interview-based measurements of breathlessness related to activities of daily living. The TDI is an evaluative instrument that includes specific criteria for each of three components (functional impairment, magnitude of task and magnitude of effort) to measure changes from a baseline state. Changes in dyspnea functional impairment were assessed on a scale from Major Deterioration (formerly working but had to stop working and abandoned usual activities due to shortness of breath) to Major Improvement (able to return to work at former pace and return to full activities with only mild restriction due to improvement of shortness of breath). Further impairment for other reasons includes participants who gave up or reduced work or other activities for reasons other than shortness of breath.|Week 12|FAS participants with available data|||Participants|||Count of Participants
2662748|NCT01559129|Secondary|Change From Baseline in UCLA SCTC GIT 2.0 Constipation Subscale Score Over Time|The UCLA SCTC GIT 2.0 is a 34-item, health-related quality of life self-administered evaluation tool, which targets GI activity and severity in patients with SSc. Individual scales include reflux, distention/bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation. The items are scored on a scale from 0 to 3, where 0 indicates better health and 3 indicates worse health. The constipation subscale score is calculated as the average of three questions regarding the frequency of constipation (scored from 0 [no days] to 3 [5-7 days/week] and one question about the presence of stools becoming harder (scored as 0 [No] or 1 [Yes]); the score ranges from 0 to 2.5, where higher scores indicate more frequent symptoms.|Baseline and Weeks 12, 24, 52 (or at the Treatment Phase Early Termination visit), 64, 76, and 156 (or the Extension Phase Early Termination visit).|FAS participants with a Baseline value and post-baseline value at each time point.|||units on a scale||Standard Deviation|Mean
2662749|NCT01559129|Secondary|Change From Baseline in UCLA SCTC GIT 2.0 Emotional Well Being Subscale Score Over Time|The UCLA SCTC GIT 2.0 is a 34-item, health-related quality of life self-administered evaluation tool, which targets GI activity and severity in patients with SSc. Individual scales include reflux, distention/bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation. The items are scored on a scale from 0 to 3, where 0 indicates better health and 3 indicates worse health. The emotional well-being subscale score is calculated as the average of nine questions regarding the impact of bowel problems on emotional status; the score ranges from 0 to 3, where higher scores indicate more frequent problems.|Baseline and Weeks 12, 24, 52 (or at the Treatment Phase Early Termination visit), 64, 76, and 156 (or the Extension Phase Early Termination visit).|FAS participants with a Baseline value and post-baseline value at each time point.|||units on a scale||Standard Deviation|Mean
2662750|NCT01559129|Secondary|Change From Baseline in UCLA SCTC GIT 2.0 Social Functioning Subscale Score Over Time|The UCLA SCTC GIT 2.0 is a 34-item, health-related quality of life self-administered evaluation tool, which targets GI activity and severity in patients with SSc. Individual scales include reflux, distention/bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation. The items are scored on a scale from 0 to 3, where 0 indicates better health and 3 indicates worse health. The social functioning subscale score is calculated as the average of six questions about how often symptoms interfered with social activities; the score ranges from 0 to 3, where higher scores indicate more frequent symptoms.|Baseline and Weeks 12, 24, 52 (or at the Treatment Phase Early Termination visit), 64, 76, and 156 (or the Extension Phase Early Termination visit).|FAS participants with a Baseline value and post-baseline value at each time point.|||units on a scale||Standard Deviation|Mean
2662784|NCT01559012|Secondary|Morning Urine Ketonuria|Morning urine ketonuria is a simple direct marker of starving associated to nausea and vomiting|participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days||||Proportion of person-days||95% Confidence Interval|Mean
2662751|NCT01559129|Secondary|Change From Baseline in UCLA SCTC GIT 2.0 Diarrhea Subscale Score Over Time|The UCLA SCTC GIT 2.0 is a 34-item, health-related quality of life self-administered evaluation tool, which targets GI activity and severity in patients with SSc. Individual scales include reflux, distention/bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation. The diarrhea subscale score is calculated as the average of one diarrhea question about the frequency of loose stools (on a scale from 0 [none] to 3 [5-7 days/week] and one question about the presence of watery stools (scored as 0 [No] or 1 [Yes]); the score ranges from 0 to 2, where a higher score indicates more frequent symptoms.|Baseline and Weeks 12, 24, 52 (or at the Treatment Phase Early Termination visit), 64, 76, and 156 (or the Extension Phase Early Termination visit).|FAS participants with a Baseline value and post-baseline value at each time point.|||units on a scale||Standard Deviation|Mean
2662752|NCT01559129|Secondary|Change From Baseline in UCLA SCTC GIT 2.0 Fecal Soilage Subscale Score Over Time|The UCLA SCTC GIT 2.0 is a 34-item, health-related quality of life self-administered evaluation tool, which targets GI activity and severity in patients with SSc. Individual scales include reflux, distention/bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation. The items are scored on a scale from 0 to 3, where 0 indicates better health and 3 indicates worse health. The fecal soilage subscale score is calculated from one soilage question; the score ranges from 0 to 3, where higher scores indicate more frequent symptoms.|Baseline and Weeks 12, 24, 52 (or at the Treatment Phase Early Termination visit), 64, 76, and 156 (or the Extension Phase Early Termination visit).|FAS participants with a Baseline value and post-baseline value at each time point.|||units on a scale||Standard Deviation|Mean
2662753|NCT01559129|Secondary|Change From Baseline in UCLA SCTC GIT 2.0 Distension/Bloating Subscale Score Over Time|The UCLA SCTC GIT 2.0 is a 34-item, health-related quality of life self-administered evaluation tool, which targets GI activity and severity in patients with SSc. Individual scales include reflux, distention/bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation. The items are scored on a scale from 0 to 3, where 0 indicates better health and 3 indicates worse health. The distension/bloating subscale score is calculated as the average of four distension/bloating-related questions; the score ranges from 0 to 3, where higher scores indicate more frequent symptoms.|Baseline and Weeks 12, 24, 52 (or at the Treatment Phase Early Termination visit), 64, 76, and 156 (or the Extension Phase Early Termination visit).|FAS participants with a Baseline value and post-baseline value at each time point.|||units on a scale||Standard Deviation|Mean
2662754|NCT01559129|Secondary|Change From Baseline in UCLA SCTC GIT 2.0 Reflux Subscale Score Over Time|The UCLA SCTC GIT 2.0 is a 34-item, health-related quality of life self-administered evaluation tool, which targets GI activity and severity in patients with SSc. Individual scales include reflux, distention/bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation. The items are scored on a scale from 0 to 3, where 0 indicates better health and 3 indicates worse health. The reflux subscale score is calculated as the average of eight reflux-related questions; the score ranges from 0 to 3, where higher scores indicate more frequent symptoms.|Baseline and Weeks 12, 24, 52 (or at the Treatment Phase Early Termination visit), 64, 76, and 156 (or the Extension Phase Early Termination visit).|FAS participants with a Baseline value and post-baseline value at each time point.|||units on a scale||Standard Deviation|Mean
2662755|NCT01559129|Secondary|Change From Baseline in UCLA SCTC GIT 2.0 Total Score Over Time|The UCLA SCTC GIT 2.0 is a 34-item, health-related quality of life self-administered evaluation tool, which targets GI activity and severity in patients with SSc. Individual scales include reflux, distention/bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation. The items are scored on a scale from 0 to 3, where 0 indicates better health and 3 indicates worse health (except for Questions 15 and 31 which are scored as 0 (better health) or 1 (worse health). The total score is calculated as the average of the first 6 scale scores (excluding constipation) which captures overall burden (severity) of SSc-associated GIT. The overall score ranges from 0 to 3, where higher scores indicate more severe symptoms.|Baseline and Weeks 12, 24, 64, 76, and 156 (or the Extension Phase Early Termination visit).|FAS participants with a Baseline value and post-baseline value at each time point.|||units on a scale||Standard Deviation|Mean
2662756|NCT01559129|Secondary|Change From Baseline in Modified Rodnan Skin Score Over Time|Improvement in skin thickening is associated with improved survival and may be useful as a surrogate measurement in clinical studies. The mRSS is an assessment tool which is used to evaluate the extent and severity of the skin thickening associated with systemic sclerosis (SSc). Seventeen body areas were evaluated on a 4-point scale (0 [normal], 1 [mild], 2 [moderate], or 3 [severe]). The total score, which is the sum of the 17 individual body assessments, can range from 0 to 51.|Baseline and Weeks 12, 24, 64, 76, and 156 (or the Extension Phase Early Termination visit).|FAS participants with a Baseline value and a post-baseline value at each time point.|||units on a scale||Standard Deviation|Mean
2662757|NCT01559129|Secondary|Change From Baseline in Percent Predicted Forced Vital Capacity Over Time|Forced vital capacity (FVC) is a pulmonary function test and is the volume of air in the lungs that can forcibly be blown out after a full inhalation. Percent predicted values are based comparison between the participant's measured value with expected FVC for someone of the same sex, age and height (reference value).|Baseline (defined as the average of all values between Screening and Baseline) and Weeks 12, 24, 36, 64, 76, and 156|FAS participants with a Baseline value and post-baseline value at the time point.|||percent predicted||Standard Deviation|Mean
2662758|NCT01559129|Primary|Change From Baseline in University of California, Los Angeles, Scleroderma Clinical Trial Consortium Gastrointestinal Tract (UCLA SCTC GIT 2.0) Total Score at Week 52/Early Termination|The UCLA SCTC GIT 2.0 is a 34-item, health-related quality of life self-administered evaluation tool, which targets gastrointestinal (GI) activity and severity in patients with SSc. Individual scales include reflux, distention/bloating, fecal soilage, diarrhea, social functioning, emotional well-being and constipation. The items are scored on a scale from 0 to 3, where 0 indicates better health and 3 indicates worse health (except for Questions 15 and 31 which are scored as 0 (better health) or 1 (worse health). The total score is calculated as the average of the first 6 scale scores (excluding constipation) which captures overall burden (severity) of SSc-associated GIT. The overall score ranges from 0 to 3, where higher scores indicate more severe symptoms.|Baseline and Week 52 (or Treatment Phase Early Termination visit)|FAS participants with a Baseline value and a Week 52 value|||units on a scale||Standard Deviation|Mean
2662760|NCT01559129|Primary|Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52|Forced vital capacity (FVC) is a pulmonary function test and is the volume of air in the lungs that can forcibly be blown out after a full inhalation. Percent predicted values are based comparison between the participant's measured value with expected FVC for someone of the same sex, age and height (reference value). For the analysis of FVC, the baseline value was defined as the average of all values between Screening and Baseline (inclusive), and the average of Weeks 48 and 52 was treated as the Week 52 value, to reduce the total data variability at the key time points.|Baseline (defined as the average of all values between Screening and Baseline) and Weeks 48 and 52|The Full Analysis Set (FAS) consisted of all randomized participants who received at least one dose of study drug. Participants with a Baseline value and a Week 52 were included in the analysis.|||percent predicted||Standard Deviation|Mean
2662761|NCT01559129|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. A TEAE is any AE that began or worsened on or after the start of study drug through 28 days after the last dose. A treatment-related TEAE is a TEAE which was considered by the investigator to be related to study drug. The severity/intensity of AEs was assessed by the investigator as Mild (asymptomatic or mild symptoms; intervention not indicated), Moderate (symptoms cause moderate discomfort, intervention may be required), or Severe (symptoms cause severe discomfort/pain, requiring medical intervention, inability to perform daily activities). A serious AE is any AE that: - Resulted in death; - Was life-threatening; - Required inpatient hospitalization or prolongation of existing hospitalization - Resulted in persistent or significant disability/incapacity; - Was a congenital anomaly/birth defect; - Constituted an important medical event.|From the start of study drug to 28 days after last dose; Treatment Phase median duration of treatment was 358 and 320 days for Placebo and Pomalidomide; Extension phase median duration of treatment was 161 days and 194 days for Placebo and pomalidomide.|All randomized participants who received at least one dose of the study treatment (either pomalidomide or placebo).|||participants|||Number
2662762|NCT01559116|Secondary|Peak (0-3h) FVC Response [L] After 6 Weeks Treatment.|"Peak (0-3h) Forced Vital Capacity (FVC) responses after 6 weeks treatment.~Peak was defined as the maximum value measured within the first 3 h post dosing and response was defined as the change from patient baseline.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS)|||Litres (L)||Standard Error|Mean
2662763|NCT01559116|Secondary|Trough FVC Response [L] After 6 Weeks Treatment.|"Trough Forced Vital Capacity (FVC) response after 6 weeks treatment period.~The trough was defined as the mean of the 23 h and 23 h50 min measurements and response was defined as the change from patient baseline.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day1 and week 6|Full Analysis Set (FAS).|||Litres (L)||Standard Error|Mean
2662764|NCT01559116|Secondary|FVC AUC12-24h Response [L] After 6 Weeks Treatment.|"Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 12 to 24 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).|||Litres (L)||Standard Error|Mean
2662765|NCT01559116|Secondary|FVC AUC0-12h Response [L] After 6 Weeks Treatment.|"Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS)|||Litres (L)||Standard Error|Mean
2662766|NCT01559116|Secondary|FVC AUC0-24h Response [L] After 6 Weeks Treatment.|"Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).|||Litres(L)||Standard Error|Mean
2662767|NCT01559116|Secondary|Peak(0-3h) FEV1 Response [L] After 6 Weeks Treatment.|"Peak (0-3h) Forced Expiratory Volume in 1 second (FEV1) response.~The peak was defined as the maximum value measured within the first 3 h post dosing and response was defined as the change from patient baseline.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).|||Litres (L)||Standard Error|Mean
2662785|NCT01559012|Primary|VAS Score for Assessment of Severity in Hyperemesis Gravidarum|VAS is a Visual Analogic Scale formulated in 5 items. Every item has a score from 0 (best) to 10 (worst). The sum range swings from 0 (best ) to 50 (worst). Participants are followed for the whole duration of hospital stay (10 days) asking them to score their symptoms daily.|Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.||||units on a scale||95% Confidence Interval|Mean
2662768|NCT01559116|Secondary|Trough FEV1 Response [L] After 6 Weeks Treatment.|"Trough Forced Expiratory Volume in 1 second (FEV1) response after 6 weeks treatment period.~The trough was defined as the mean of the 23 h and 23 h50 min measurements and Response was defined as the change from patient baseline.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS)|||Litres||Standard Error|Mean
2662769|NCT01559116|Secondary|FEV1 AUC12-24h Response [L] After 6 Weeks Treatment.|"Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 12 to 24 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).|||Litres (L)||Standard Error|Mean
2662770|NCT01559116|Secondary|FEV1 AUC0-12h Response [L] After 6 Weeks Treatment.|"Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 12 h post-dose, using the trapezoidal rule, divided by the duration (12h) to report in litres.~Mean is actually the Adjusted mean.~The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS).|||Litres (L)||Standard Error|Mean
2662771|NCT01559116|Primary|Forced Expiratory Volume in 1 Second (FEV1) AUC0-24h Response [L] After 6 Weeks Treatment.|"Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 24 h post-dose, using the trapezoidal rule, divided by the duration (24 h) to report in litres.~Mean is actually the Adjusted mean.~The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within−patient variation and Kenward−Roger approximation of denominator degrees of freedom."|day 1 and week 6|Full Analysis Set (FAS): This patient set included patients in the Treated Set (TS) who had any period baseline and any evaluable post-dose data for the primary efficacy endpoint at any Week 6 visits.|||Litres (L)||Standard Error|Mean
2662772|NCT01559090|Secondary|Anti-drug Antibody (ADA)|MEDI-546 antibody detection measured by electrochemiluminescence (ECL).|Stage I (up to Week 48)||||Participants|||Count of Participants
2662773|NCT01559090|Secondary|Pharmacokinetic Parameters of MEDI-546 After Single Dose: AUClast||Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29||||ug.day/mL||Geometric Coefficient of Variation|Geometric Mean
2662774|NCT01559090|Primary|Overall Summary of Adverse Events||Stage I (up to 48 weeks)||||Participants|||Count of Participants
2662775|NCT01559090|Secondary|Pharmacokinetic Parameters of MEDI-546 After Single Dose: Cmax||Pre-dose and within 30 minutes after end of infusion on Day 1, Days 2, 8, 15, and 22, and pre-dose on Day 29||||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2662776|NCT01559064|Primary|Subject Experience Measured by Patient Satisfaction Questionnaire|Subject satisfaction with treatment, based on a 5-point scale: (1) Delighted, (2) Happy, (3) Neutral, (4) Unhappy, (5) Very Unhappy|3 weeks||||Units on a scale||Standard Deviation|Mean
2662777|NCT01559012|Secondary|Diastolic Blood Pressure|Diastolic BP was recorded every day during clonidine (5 days) and placebo (5 days) cycle|10 days||||mmHg||95% Confidence Interval|Mean
2662778|NCT01559012|Secondary|Systolic Blood Pressure|Systolic BP was measured every day during the clonidine treatment (5 days) and placebo (5 days)|10 days||||mmHg||95% Confidence Interval|Mean
2662779|NCT01559012|Secondary|Newborn Outcome Measure: APGAR Score.|"The APGAR score is the most common indicator of neonatal status immediately after delivery.~The test is done by a doctor, midwife, or nurse. The health care provider will examine the baby's:~Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition. The APGAR rating is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth."|at 1 minute and at 5 minutes after delivery|APGAR score of newborns at 1 minute and at 5 minutes|||units on a scale||Full Range|Mean
2662780|NCT01559012|Secondary|Pregnancy Outcome Measures: Birth Weight.|Birth weight adjusted for gestational age at delivery is a measure of pregnancy outcome after treatment of HG.|at delivery|no determination of sample size Recording for safety issue|||grams||Full Range|Mean
2662781|NCT01559012|Secondary|Number of Patients Choosing Active Treatment for Off-label, Compassionate Use.|the patients were asked to choose between two transdermal systems (active drug versus placebo) as the most effective|at 10 days since start of treatment|no determination of sample size|||participants|||Number
2662782|NCT01559012|Secondary|Number of Days Off i.v. Therapy, the TD System (Clonidine/Placebo) Being Applied Only|if the symptoms improve the patient and her doctors may decide to stop parenteral drugs continuing the TD system therapy.|participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days||||Proportion of person-days||95% Confidence Interval|Mean
2662783|NCT01559012|Secondary|Daily Doses of Standard Antiemetic Drugs Required in the Two Different Periods.|"The patients were randomly treated with and without TD clonidine (5mg patch) for 2 consecutive periods of 5 days , other antiemetic drugs (promethazine, prochlorperazine, metoclopramide, ondansetron) and anti reflux drugs (ranitidine, omeprazole) being administered on a scheduled or as-needed basis.~All patients received intravenous hydration and supplementation with thiamine, during both periods. The use of steroids was allowed as a rescue medication in case of further worsening of symptoms."|participants are followed for the whole duration of hospital stay (10 days) comparing the first period of 5 days with the second period of 5 days||||daily doses of antiemetics||95% Confidence Interval|Mean
2662786|NCT01559012|Primary|PUQE Score for Assessment of Severity in Hyperemesis Gravidarum|"PUQE in an acronym for Pregnancy Unique Quantification of Emesis, a validated clinical score for assessment of severity of emesis in pregnancy.~It is composed of three items; every item has a score from 1 (best) to 5 (worst).~The sum range varies from 3 (best) to 15 (worst). Participants are followed for the whole duration of hospital stay (10 days) asking them to score their symptoms daily."|Mean values of first period of five days are compared with mean values of second period of five days. Change is reported as baseline value - value at day 5 or at day 10.|A sample size calculation for crossover studies using a model available on line (MGH Mallinckrodt General Clinical Research Center - Harvard Medical School) showed that a total of 12 patients were needed in order to detect a difference of 2 points of PUQE score between the two groups at P < 0.01 and a beta > 0.90.|||units on a scale||95% Confidence Interval|Mean
2662787|NCT01558791|Secondary|Feasibility Questionnaire|A brief feasibility questionnaire will be used to evaluate provider feedback regarding administering the educational handout as part of the TBI clinical reminder.|One month- Providers complete a questionnaire within 1 month after data collection ends for the site.|PI and project staff no longer have access to this data to report results.||||||
2662788|NCT01558791|Primary|Illness Perception - Duration of Symptoms|Participants rate on a Likert Scale from 0-10 how long they think their current symptoms will continue with 0 being a very short time and 10 being forever.|One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.|All veterans screened who accepted questionnaire|||units on a scale||Standard Deviation|Mean
2662789|NCT01558791|Primary|Illness Perception - Current Symptoms|Participants rate on a Likert Scale from 0-10 how much their current symptoms affect their life, with 0 being no affect, and 10 being severe.|One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.|All veterans who accepted questionnaire|||units on a scale||Standard Deviation|Mean
2662790|NCT01558791|Primary|mTBI Questionnaire|The primary outcome is knowledge gained about mTBI and illness perception. This is evaluated by number correct out of 10 true or false questions.|One day- Participants complete a questionnaire within 1 day of TBI screening. There is no follow up assessment.|All veterans screened who accepted the questionnaire.|||correct answers out of 10||Standard Deviation|Mean
2662791|NCT01558739|Secondary|Percentage of Participants With Transfusion Dependency Status|Transfusion dependency status from baseline through the end of study was assessed. New onset of transfusion dependency was defined as the use of 2 or more units of red blood cell products during the 8 weeks prior to a study visit. New onset of transfusion independency was defined as the use of 0 or 1 unit of red blood cell products during the 8 weeks prior to a study visit.|baseline (BL), end of treatment (up to 28 days post last treatment) (EOT)|Full analysis set (FAS): The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.|||Percentage of participants|||Number
2662792|NCT01558739|Secondary|Number of General Practitioner (GP), Specialists' and Urgent Care Visits|MRU was assessed according to the number of GP, specialists', and urgent care visits.|baseline to week 12, week 12 to, week 24, week 24 to week 36, week 36 to week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at each timeframe, e.g. from baseline to week 12, were included in the analysis for that timeframe. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.|||number of visits||Full Range|Median
2662793|NCT01558739|Secondary|Number of Accident & Emergency Visits From Baseline|MRU was assessed according to the number of accidents and emergency room visits.|baseline to week 12, week 12 to week 24, week 24 to week 36, week 36 to week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at each timeframe, e.g. from baseline to week 12, were included in the analysis for that timeframe. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.|||Number of visits||Full Range|Median
2662794|NCT01558739|Secondary|Duration of Hospitalizations|MRU was assessed according to the mean duration of hospitalization visits.|week 48|Participants from the full analysis set, who were hospitalized between baseline and week 48, were included in the analysis.|||days||Standard Deviation|Mean
2662795|NCT01558739|Secondary|Number of Hospitalizations|Medical resource utilization (MRU) was assessed according to the number of hospitalizations.|week 12, week 24, week 26, week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at the post-baseline week time point, were included in the analysis for that time point. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.|||number of hospitalizations||Standard Deviation|Mean
2662796|NCT01558739|Secondary|Change From Baseline in EQ5D Preference Index (5 Level EuroQol Questionnaire Determining Quality of Life) From Baseline|The EQ-5D is a standardized instrument used for measuring health outcomes in a wide range of health conditions and treatment. It consists of a descriptive system and a visual analogue scale (EQ-VAS). The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The EQ-VAS records the participant's self-rated health on a vertical, VAS where the endpoints are labeled 'best imaginable health state' and 'worst imaginable health state'. The EQ-5D health state was converted to a single summary index by applying a formula that attaches a weight to each of the levels in each dimension. The final EQ5D preference index scores range from 0 to 1 with higher scores indicating better health.|Baseline, week 4, week 12, week 24, week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at both baseline and the post-baseline week time point, was included in the analysis for that time point. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.|||unit on a scale||Standard Deviation|Mean
2662820|NCT01558635|Secondary|Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 12 Months Post-procedure or Prior to Hospital Discharge, Whichever Came Last|"The composite MAE was defined as a subject experiencing any of the following adverse events:~Stroke~Transient ischemic attack (TIA)~Pulmonary embolism~Peripheral arterial embolism~Myocardial infarction (MI)~Mediastinitis~Esophageal injury~Death~Cardiac injury related to the use of the Cardioblate CryoFlex System that required additional surgical or catheter intervention"|12 months||||Participants|||Count of Participants
2662797|NCT01558739|Secondary|Change From Baseline in Myelofibrosis Symptoms Assessment Form (MF-SAF)|The MF-SAF consists of seven questions about key symptoms and impact of MF. Questions are scored on a scale of 0-10, with higher scores indicating more severe symptoms and greater inactivity. Questions 1-6, which together comprise a Total Symptom Score (TSS), investigate the following symptoms: night sweats, pruritus/itching, abdominal discomfort, pain under the ribs, early satiety and bone/muscle pain. Question 7 asks patients to report levels of inactivity. The TSS reflects the sum of the scores of these symptoms excluding inactivity, with the maximum possible score being 60 (most severe symptom experienced).|Baseline, week 4, week 12, week 24, week 48|Only participants from the full analysis set (FAS), who had evaluable measurements at both baseline and the post-baseline week time point, was included in the analysis for that time point. The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.|||score on a scale||Standard Deviation|Mean
2662798|NCT01558739|Secondary|Percentage of Participants With Best Overall Response|Response to treatment and disease progression was assessed by physical examination, specifically assessing changes in spleen size by palpation. Disease response and progression was evaluated using the International Working Group for myelofibrosis Research and Treatment Response Criteria.|week 48|Full Analysis Set (FAS): The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.|||Percentage of participants|||Number
2662799|NCT01558739|Primary|Percentage of Participants With Treatment Success|Treatment success was defined as a 50% or greater reduction in palpable spleen length versus baseline at 48 weeks and/or a 50% or greater improvement in total symptom score (derived from the MF symptom assessment form (MFSAF) questionnaire) versus baseline at the week 48 time point. The MFSAF assesses the following symptoms (all scored from absent (0) to worst imaginable (10)): general fatigue, abdominal pain (and discomfort), inactivity (ability to move and walk around), cough, night sweats, itching (pruritus), bone pain (diffuse not joint pain or arthritis), fever, change in appetite/unintentional weight loss (or gain) in past 6 months, overall quality of life (QoL).|48 Weeks|Full analysis set (FAS): The FAS included all participants who received at least one administration of study drug and had at least one post-baseline efficacy assessment.|||Percentage of participants|||Number
2662800|NCT01558700|Secondary|Change in Pain Magnitude|The Western Ontario and McMaster Osteoarthritis Index (WOMAC) score change was assess by subtracting WOMAC score after treatment (week 16) to the baseline WOMAC score. WOMAC score has a range from 0 up to 96, higher score meaning worse condition. The outcome is the decrease in WOMAC scores, meaning that the higher is the decrease, the most improvement in the condition.|16 weeks compared to baseline||||Scores on a scale||Standard Deviation|Mean
2662801|NCT01558700|Primary|Change in Brain Gray Matter Volume|The change in gray matter volume is evaluated by subtracting the volume after the treatment (week 16) to the volume before treatment (baseline)|16 weeks compared to baseline||||percentage of change||Standard Deviation|Mean
2662802|NCT01558674|Secondary|Apparent Terminal Half-life (t1/2) of MK-7145 (Part 2)|Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 to determine the t1/2.|up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4|No participants were enrolled in Part 2 of the study.||||||
2662803|NCT01558674|Secondary|Time to Cmax (Tmax) of MK-7145(Part 2)|Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 to determine the Tmax.|up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4|No participants were enrolled in Part 2 of the study.||||||
2662804|NCT01558674|Secondary|Trough Plasma Concentration (Ctrough) of MK-7145 (Part 2)|Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4 to determine the Ctrough.|up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4|No participants were enrolled in Part 2 of the study.||||||
2662805|NCT01558674|Secondary|Maximum Plasma Concentration (Cmax) of MK-7145 (Part 2)|Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 2-4 to determine the Cmax.|up to 24 hours post morning dose on up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4|No participants were enrolled in Part 2 of the study.||||||
2662806|NCT01558674|Secondary|Area Under the Concentration-time Curve From Time Zero to 24 Hours After Dosing (AUC0-24hr) of MK-7145 (Part 2)|Blood samples taken at predose, 0.5, 1, 2, 5, 8, 12, 14 and 24 hours postdose on Days 1 and 14 of Period 2 and Day 14 of Periods 3-4 to determine the AUC0-24hr|up to 24 hours post morning dose on Days 1 and 14 of Period 2 and Day 14 of Periods 3 and 4|No participants were enrolled in Part 2 of the study.||||||
2662807|NCT01558674|Secondary|Serum Creatinine Measured at 24 Hours Post Last Morning Dose of Each Period (Part 2)|Blood samples were collected at 24 hours post last morning dose of each period to determine serum creatinine levels|Day 15 for Periods 1, 2, and 3; Day 29 for Period 4|No participants were enrolled in Part 2 of the study.||||||
2662808|NCT01558674|Secondary|Apparent Terminal Half-life (t1/2) of MK-7145 (Part 1)|Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24, 96, 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The t1/2 was calculated.|Treatment Day 1 and Treatment Day 5|All participants who received at least 1 dose of MK-7145 and who complied with the protocol sufficiently and had data available for endpoint. t1/2 could not be estimated due to insufficient terminal phase sample. Part 1: Period 3 was not conducted.|||hours||95% Confidence Interval|Median
2662809|NCT01558674|Secondary|Time to Cmax (Tmax) of MK-7145(Treatment Days 1 and 5: Part 1)|Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24, 96 , 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The time to Cmax (Tmax) calculated for Treatment Days 1 and 5|Treatment Day 1 and Treatment Day 5|All participants who received at least 1 dose of MK-7145 who complied with the protocol sufficiently and had data available for endpoint. Part 1: Period 3 was not conducted.|||hours||Full Range|Median
2663020|NCT01556763|Primary|EVP-6124 Half-life (T[1/2]), Patients on Aripiprazole|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|Patients receiving aripiprazole for whom blood samples were available for analysis.|||hr||Standard Deviation|Mean
2662810|NCT01558674|Secondary|Trough Plasma Concentration (Ctrough) of MK-7145 (Treatment Days 1 and 5: Part 1)|Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24 , 96 , 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The Ctrough for was calculated for Treatment Days 1 and 5|Treatment Day 1 and Treatment Day 5|All participants who received at least 1 dose of MK-7145, who complied with the protocol sufficiently and had data available for endpoint. Ctrough for MK-7145 8 mg arm could not be estimated due to insufficient terminal phase sample. Part 1: Period 3 was not conducted.|||nM||Geometric Coefficient of Variation|Geometric Mean
2662811|NCT01558674|Secondary|Maximum Plasma Concentration (Cmax) of MK-7145 (Treatment Days 1 and 5: Part 1)|Blood samples for pharmacokinetic analysis were collected on Treatment Day 1 through Treatment Day 5 at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24, 96, 101, 104, 106, 108, 110 and 120 hours (relative to Treatment Day 1 dosing). The Cmax was calculated for Treatment Days 1 and 5.|Treatment Day 1 and Treatment Day 5|All participants who received at least 1 dose of MK-7145, who complied with the protocol sufficiently and had data available for endpoint. Part 1: Period 3 was not conducted|||nM||Geometric Coefficient of Variation|Geometric Mean
2662812|NCT01558674|Secondary|Area Under the Concentration-time Curve From Time Zero to 24 Hours After Dosing (AUC0-24hr) of MK-7145 (Treatment Days 1 and 5: Part 1)|Blood samples for pharmacokinetic analysis were collected on Day 4 (Treatment Day 1) through Day 8 (Treatment Day 5) at the following time points: Predose, 3, 5, 6, 8, 10, 12, 14, 18, 24 , 96, 101, 104, 106, 108, 110 and 120 hours (relative to Day 4 dosing). The AUC0-24 was calculated for Days 1 and 5|up to 24 hours post-dose on Treatment Day 1 and Treatment Day 5|All participants who received at least 1 dose of MK-7145, who complied with the protocol sufficiently and had data available for endpoint. Part 1: Period 3 was not conducted|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
2662813|NCT01558674|Secondary|Fold Change From Baseline for Serum Creatinine at 24-hours Post Treatment Day 5 Morning Dose (Part 1)|Blood was collected predose on Treatment Day 1 and at 24 hours post morning dose on Treatment Day 5 to determine serum creatinine levels. Creatinine levels were log transformed and then fold change from baseline was calculated.|Baseline (predose Treatment Day 1) and 24 hours post morning dose on Treatment Day 5 of each treatment period (Part I)|All participants who received at least 1 dose of study drug , who complied with the protocol sufficiently and had data available for endpoint. Part 1: Period 3 was not conducted.|||mg/dL||95% Confidence Interval|Geometric Mean
2662814|NCT01558674|Primary|N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) Values at 24 Hours Post Last Morning Dose of Each Period (Part 2)|B-type natriuretic peptide (BNP) is a substance secreted from the ventricles or lower chambers of the heart in response to changes in pressure that occur when heart failure develops and worsens. The level of BNP in the blood increases when heart failure symptoms worsen, and decreases when the heart failure condition is stable. The BNP level in a person with heart failure is higher than in a person with normal heart function. Levels of BNP levels were assessed 24 hours post last morning dose of study drug for each treatment period.|Day 15 for Periods 1, 2, and 3; Day 29 for Period 4|Part 2 of the study was not conducted. No participants were enrolled.||||||
2662815|NCT01558674|Primary|Change From Baseline in First 24hr Urinary Sodium (UNa) (Part 1)|Urine was collected at Treatment Day -1 and Treatment Day 1 at 0-2, 2-4, 4-6, 6-8, 8-12, 12-24 hour. The 24-hour cumulative natriuresis will be estimated by the amount of sodium excreted into urine over 24 hour period postdose, where amount of sodium is the product of sodium concentration and the volume of urine. The change from baseline in UNa from baseline (Treatment Day -1) and 24 hours post-dose on Treatment Day 1 were calculated.|Baseline (Day -1) and 0-24 hours postdose on Treatment Day 1 of each treatment period|All participants who received at least 1 dose of study drug and who complied with the protocol sufficiently. One participant did not participate for several time intervals on Period 2: Day 8 due to being unwell, and data from this day of this participant were excluded from the analysis. Part 1: Period 3 was not conducted.|||mEq||95% Confidence Interval|Least Squares Mean
2662816|NCT01558661|Secondary|Number of Participants With Next Generation Sequencing (NGS)|Next generation sequencing the t(6;9) translocation (MYBNFIB gene product) status will be analyzed by Fluorescent In-Situ Hybridization (FISH) assay and correlated to clinical response. The number of participants with NGS will be recorded.|2 years|One patient enrolled in the second stage was determined to be ineligible and was replaced after two doses. This patient was considered evaluable for Best Overall Response, but not Progression Free Survival.|||Participants|||Count of Participants
2662817|NCT01558661|Secondary|MYB Immunohistochemistry (IHC)||2 years|MYB immunohistochemistry (IHC) was carried out on tumors from 33 patients. MYB quantification was assessed as: 2+ for strong staining in >50% of cancer cells, 1+ for weak or strong staining in <50% of the cells and 0 for <5% staining.|||Participants|||Count of Participants
2662818|NCT01558661|Secondary|Median Progression-free Survival (PFS).|"Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|2 years|One patient enrolled in the second stage was determined to be ineligible and was replaced after two doses. This patient was considered evaluable for Best Overall Response, but not Progression Free Survival.|||months||95% Confidence Interval|Median
2662819|NCT01558661|Primary|Overall Response Rate|Best overall response rate documented by RECIST v1.1 criteria of patients with progressive, recurrent/metastatic ACC treated with axitinib. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions|2 years|One patient enrolled in the second stage was determined to be ineligible and was replaced after two doses. This patient was considered evaluable for Best Overall Response, but not for Progression Free Survival.|||Participants|||Count of Participants
2668479|NCT01505764|Secondary|Muscle Strength as Measured by Grip Strength.|Dominant hand grip strength day 84 - percent change from baseline|day 84|Cancer cachexia patients|||percentage change||Standard Deviation|Mean
2662821|NCT01558635|Secondary|Assessment of Quality of Life as Measured by the SF-12 at Baseline, 6 and 12 Months After the Procedure|The 12-Item Short Form Health Survey (SF-12) is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Ten summary scores are reported from the SF-12. The scale range for each of the ten subscales is from 0 to 100, with higher scores corresponding to a better outcome. Subjects average unit score (with standard deviation) are reported at baseline, 6 and 12 months. As unit of measure we used units on a scale.|6 and 12 months||||units on a scale||Standard Deviation|Mean
2662822|NCT01558635|Secondary|AF Burden in Subjects Diagnosed With Longstanding Persistent AF as Measured by Reveal XT Recordings at 3, 6 and 12 Months|AF burden is defined as percentage of time the patient is in AF during 24 hours.|3, 6 and 12 Months||||percentage of AF burden||Standard Deviation|Mean
2662823|NCT01558635|Secondary|Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs||6 Months||||Participants|||Count of Participants
2662824|NCT01558635|Secondary|Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs||3 Months||||Participants|||Count of Participants
2662825|NCT01558635|Secondary|Number of Participants With Freedom From AF Regardless of Use of Anti-Arrhythmic Drugs||12 Months|All subjects who underwent ablation therapy and who had data from the Reveal XT Insertable Cardiac Monitor|||Participants|||Count of Participants
2662826|NCT01558635|Primary|Safety: Rate of Device and Procedure Related Acute Major Adverse Events (MAE) Within 30 Days Post-procedure or Prior to Hospital Discharge, Whichever Came Last|"The composite MAE was defined as a subject experiencing any of the following adverse events:~Stroke~Transient ischemic attack (TIA)~Pulmonary embolism~Peripheral arterial embolism~Myocardial infarction (MI)~Mediastinitis~Esophageal injury~Death~Cardiac injury related to the use of the Cardioblate CryoFlex System that required additional surgical or catheter intervention"|30 days|All subjects treated with the Cardioblate Cryoflex Surgical Ablation System.|||Participants|||Count of Participants
2662827|NCT01558635|Primary|Efficacy: Percentage of Treated Subjects Diagnosed With Longstanding Persistent AF Off Class I or III Antiarrhythmic Drugs and Out of AF at 12 Months, and Who Did Not Receive Additional Ablation Therapy for AF Prior to the 12-month Evaluation.|The primary efficacy endpoint was defined as the percentage of subjects diagnosed with longstanding persistent AF off Class I or III antiarrhythmic drugs and out of AF, as determined by Reveal XT recordings (AF burden < 0.5% per 24h) at 12 months and who did not receive additional ablation therapy for AF prior to the 12-month evaluation. An additional ablation therapy could include percutaneous catheter ablation or AV nodal ablation (cauterizing or freezing the AV node). Cardioversions were allowed only during the 12 week blanking period.|12 months|There were 11 subjects with data at 12 months, including antiarrhythmic drug, ablation, and cardioversion data. However, only six subjects had the AF burden data required for the primary efficacy endpoint.|||Participants|||Count of Participants
2662828|NCT01558596|Primary|Troponin I Elevation Above the Upper Reference Limit (URL)|Troponin I is a biomarker of myocardial necrosis that may indicate myocardial damage or injury that occurs during the perioperative period|Within 3 days of the vascular operation||||participants|||Number
2662829|NCT01558492|Secondary|Change in Survival Status||6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months and 48 months.|This study was terminated early due to poor accrual. There were no publications as a result. Data were not collected.||||||
2662830|NCT01558492|Primary|Change in Tumor Size|Assessed by CT or MRI scan and/or bone scan.|Baseline, week 12, week 24 and end of study.|This study was terminated early due to poor accrual. There were no publications as a result. Data were not collected.||||||
2662831|NCT01558492|Primary|Change in Prostate-specific Antigen (PSA) Level||Baseline, week 4, week 8, week 12, week 16, week 20, week 24 and end of study.|This study was terminated early due to poor accrual. There were no publications as a result. Data were not collected.||||||
2662832|NCT01558297|Primary|Body Weight in Pounds.|Body weight lost in pounds measured 6 months after first treatment session (3 month follow-up after active treatment ends).|6 months after treatment start (Baseline)|Intent-to-treat data are presented, with the last observation carried forward, and outliers beyond 3 standard deviations replaced with highest recorded value within the 3 standard deviation range.|||pounds||Standard Deviation|Mean
2662833|NCT01558297|Primary|Body Weight in Pounds.|Body weight lost in pounds measured 3 months after first treatment session.|3 months after treatment start (Baseline)|Intent-to-treat data are presented, with the last observation carried forward, and outliers beyond 3 standard deviations replaced with highest recorded value within the 3 standard deviation range.|||pounds||Standard Deviation|Mean
2662834|NCT01558297|Primary|Body Weight in Pounds.|Body weight lost in pounds measured 1.5 months after first treatment session.|1.5 months after treatment start (Baseline)|Intent-to-treat data are presented, with the last observation carried forward, and outliers beyond 3 standard deviations replaced with highest recorded value within the 3 standard deviation range.|||pounds||Standard Deviation|Mean
2662835|NCT01558271|Secondary|Change From Baseline in Electrocardiogram Parameters at 26 Weeks and 52 Weeks|Fridericia Corrected QT (QTcF) Interval and PR Interval are summarized. The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. LS means were calculated using ANCOVA model with treatment as a fixed effect and the baseline ECG parameter as the covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable ECG data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||milliseconds (msec)||Standard Error|Least Squares Mean
2662836|NCT01558271|Secondary|Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26 Weeks and 52 Weeks|Additional intervention was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. The number of participants requiring additional intervention due to hyperglycemia is summarized cumulatively at 26 and 52 weeks.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication.|||participants|||Number
2662837|NCT01558271|Secondary|Number of Participants With Treatment-Emergent LY2189265 Anti-Drug Antibodies (ADAs) at 26 Weeks and 52 Weeks|A participant was considered to have treatment-emergent LY2189265 ADAs if the participant had at least 1 titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from the baseline measurement.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication and had LY2189265 evaluable ADA data.|||participants|||Number
2662838|NCT01558271|Secondary|Change From Baseline in Serum Calcitonin at 26 Weeks and 52 Weeks||Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable serum calcitonin data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||picograms/milliliter||Inter-Quartile Range|Median
2662839|NCT01558271|Secondary|Change From Baseline in Pancreatic Enzymes at 26 Weeks and 52 Weeks|Pancreatic enzyme (lipase and total amylase) concentrations were measured.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable pancreatic enzyme data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||units/liter||Inter-Quartile Range|Median
2662840|NCT01558271|Secondary|Number of Participants With Adjudicated Pancreatitis at 26 Weeks and 52 Weeks|Events of pancreatitis (including suspected pancreatitis and severe or serious abdominal pain) were adjudicated by a committee of expert physicians external to the Sponsor. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication.|||participants|||Number
2662841|NCT01558271|Secondary|Change From Baseline in Blood Pressure at 26 Weeks and 52 Weeks|Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline blood pressure as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable blood pressure data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||milliliters of mercury (mmHG)||Standard Error|Least Squares Mean
2662842|NCT01558271|Secondary|Change From Baseline in Pulse Rate at 26 Weeks and 52 Weeks|Sitting pulse rate was measured. LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline pulse rate as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable pulse rate data. Only pre-rescue measurements were used. LOCF was used to impute missing postbaseline values. If there were no data after the date of randomization, the endpoint was considered missing.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2662843|NCT01558271|Secondary|Number of Participants With Adjudicated Cardiovascular Events at 26 Weeks and 52 Weeks|Deaths and nonfatal cardiovascular adverse events were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular events subjected to adjudication included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication.|||participants|||Number
2662844|NCT01558271|Secondary|30-Day Rate of Hypoglycemic Episodes|The 30-day total hypoglycemia rate over 26 weeks and 52 weeks of treatment is summarized. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication. One participant in the Liraglutide reporting group received study drug but discontinued from the study on the same day and, therefore, was not included in the analysis.|||events per participant per 30 days||Standard Deviation|Mean
2662845|NCT01558271|Secondary|Percentage of Participants With Hypoglycemic Episodes|The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least one hypoglycemic episode over the 26-week or 52-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through 26 weeks and Baseline through 52 weeks|Participants who received at least one dose of study medication.|||percentage of participants|||Number
2662846|NCT01558271|Secondary|Change From Baseline in Beta-cell Function Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks|HOMA 2 quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state beta-cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Change in beta-cell function was assessed based on change from baseline of HOMA2-%B using fasting insulin (FI) and fasting C-peptide (FCP). LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline HOMA2-%B as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable HOMA2-%B data. Only pre-rescue measurements were used. Missing endpoints were imputed with the LOCF method, using only postbaseline data.|||percentage of HOMA2||Standard Error|Least Squares Mean
2668480|NCT01505764|Secondary|Lean Mass Measured by Densitometry.|lean body mass measured by DEXA. Percentage of change day 84-baseline.|day 84|only two subjects in each group completed this measure.|||percentage change||Standard Deviation|Mean
2662847|NCT01558271|Secondary|Change From Baseline in Insulin Sensitivity Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks|HOMA 2 quantifies insulin resistance and beta-cell function. HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. Change in insulin sensitivity was assessed based on change from baseline of HOMA2-%S using fasting insulin (FI) and fasting C-peptide (FCP). LS means were calculated using ANCOVA model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline HOMA2-%S as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable HOMA2-%S data. Only pre-rescue measurements were used. Missing endpoints were imputed with the LOCF method, using only postbaseline data.|||percentage of HOMA2||Standard Error|Least Squares Mean
2662848|NCT01558271|Secondary|Change From Baseline in Body Weight at 26 Weeks and 52 Weeks|LS means were calculated using MMRM analysis with treatment, visit, treatment-by-visit, prestudy therapy (OAM yes/no), baseline BMI group (<25 or >=25 kg/m^2) as fixed effects, baseline body weight as a covariate, and participant as a random effect.|Baseline, 26 weeks, 52 weeks|Participants who received at least one dose of study medication with evaluable body weight data. Only pre-rescue measurements were used.|||kilograms (kg)||Standard Error|Least Squares Mean
2662849|NCT01558271|Secondary|Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks|Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal, and at bedtime. LS means were calculated using analysis of covariance (ANCOVA) model with treatment, prestudy therapy (OAM yes/no), and baseline BMI group (<25 or >=25 kg/m^2) as fixed effects and baseline SMBG as a covariate.|Baseline, 26 weeks, 52 weeks|Participants who received at least one dose of study medication with evaluable SMBG data. Only pre-rescue measurements were used. Missing endpoints were imputed with the LOCF method, using only postbaseline data.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2662850|NCT01558271|Secondary|Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks|LS means were calculated using MMRM analysis with treatment, visit, treatment-by-visit, prestudy therapy (OAM yes/no), baseline BMI group (<25 or >=25 kg/m^2) as fixed effects, baseline FBG as a covariate, and participant as a random effect.|Baseline, 26 weeks, 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable FBG data. Only pre-rescue measurements were used.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2662851|NCT01558271|Secondary|Percentage of Participants Who Achieved HbA1c <=6.5% or <7%|The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% at Week 26 and Week 52 was analyzed with a Cochran-Mantel-Haenszel test stratified by prestudy therapy (OAM yes/no) and baseline BMI group (<25 or >=25 kg/m^2).|Up to 26 and 52 weeks|Participants who were randomized and received at least one dose of study medication with evaluable HbA1c data. Only pre-rescue measurements were used. Missing endpoints were imputed with the last observation carried forward (LOCF), using only postbaseline data.|||percentage of participants|||Number
2662852|NCT01558271|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weeks|LS means were calculated using MMRM analysis with treatment, visit, treatment-by-visit, prestudy therapy (OAM yes/no), baseline BMI group (<25 or >=25 kg/m^2) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.|Baseline, 52 weeks|Participants who received at least one dose of study medication with evaluable HbA1c data. Only pre-rescue measurements were used.|||percentage of HbA1c||Standard Error|Least Squares Mean
2662853|NCT01558271|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks|Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis with treatment, visit, treatment-by-visit, prestudy therapy (oral antihyperglycemic medication [OAM] yes/no), baseline body mass index (BMI) group (<25 or >=25 kilograms per meter squared [kg/m^2]) as fixed effects, baseline HbA1c as a covariate, and participant as a random effect.|Baseline, 26 weeks|Participants who received at least one dose of study medication with evaluable HbA1c data. Only pre-rescue measurements were used.|||percentage of HbA1c||Standard Error|Least Squares Mean
2662854|NCT01558128|Primary|Subject Rhythm|Measuring change from baseline cardiac rhythm.|Participants will be followed for the duration of their hospital stay post surgery with an expected average of 7 to 10 days and again at surgical follow up appointment up to 6 weeks.|Converted to normal sinus rhythm|||Participants|||Count of Participants
2662855|NCT01558089|Secondary|Predictor of Good EULAR Response Versus Moderate/No Response at Visit 4 (Month 6) - DAS28 (LOCF)|In a first step a univariate logistic regression model was fit for the following baseline variables: DAS28 (n=48), Physician's Global Assessment of Disease Activity (VAS) (n=47), Patient's Global Assessment of Disease Activity (VAS) (n=47), CRP (n=46), Patient Pain (VAS) (n=47), HAQ-DI (n=47), EQ-5D (n=47). Only those variables that were significant at a 10% level were then included in the second step: a multivariate analysis with stepwise regression (entry level=10%, stay level=5%). The final model presented in the Basic Results table displays those covariates which were significant at the 2-sided 5% level (baseline value for DAS28; n=48). Note that DAS28 is not a categorical variable; therefore no stratified results for this variable are presented.|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.|||Odds Ratio (per unit increase)||95% Confidence Interval|Number
2662856|NCT01558089|Secondary|Change From Baseline in HAQ-DI at Visit 4 (Month 6)|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is composed of 20 items. It is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; common activities over past week. Each item scored on 4-point scale from 0-3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score ranges from 0-3: 0=least difficulty and 3=extreme difficulty.|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.|||units on scale||Standard Deviation|Mean
2668481|NCT01505764|Primary|Total Body Potassium.|percentage change from baseline|day 84|cancer cachexia patients|||percentage change||Standard Deviation|Mean
2662857|NCT01558089|Secondary|Change From Baseline in EQ-5D Health Index at Visit 4 (Month 6)|The European Quality of Life-5 Dimensions (EQ-5D) was measured on a 5 item scale. The scores for the 5 items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) ranged from 1 (no problem) to 3 (extreme problems). For EQ-5D, participants rate questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each of the 5 dimensions is divided into 3 levels of perceived problems: Level 1=no problem; level 2=some problem; level 3=extreme problem. A unique health state is defined by combining 1 level from each dimension. A total of 243 possible health states are defined in this way. Each state is referred to in terms of a 5 digit code. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.|||units on scale||Standard Deviation|Mean
2662858|NCT01558089|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Visit 4 (Month 6)||Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.|||mm/hour||Standard Deviation|Mean
2662859|NCT01558089|Secondary|Change From Baseline in Patient's Assessment of General Health (VAS) at Visit 4 (Month 6)|The patients used a 100 mm Visual Analogue Scale (VAS) to score their general health during the last week. The scale ranged from 0 (no pain) to 100 mm (severe pain)|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.|||mm||Standard Deviation|Mean
2662860|NCT01558089|Secondary|Change From Baseline in Swollen Joint Count at Visit 4 (Month 6)|In order to calculate the DAS28 the number of swollen joints and tender joints were assessed using the 28 Joint Count (TJC28 and SJC28). A joint was counted as tender/swollen if the tender/swelling code was 'Present'. Swollen and tender 28 joint counts will be performed at visit 1 (baseline), visit 2, visit 3 and visit 4 or early withdrawal.|Baseline and Visit 4 (Month 6)|The analysis was based on the FAS population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.|||Joints||Standard Deviation|Mean
2662861|NCT01558089|Secondary|Change From Baseline in Tender Joint Count at Visit 4 (Month 6)|In order to calculate the DAS28 the number of swollen joints and tender joints were assessed using the 28 Joint Count (TJC28 and SJC28). A joint was counted as tender/swollen if the tender/swelling code was 'Present'. Swollen and tender 28 joint counts will be performed at visit 1 (baseline), visit 2, visit 3 and visit 4 or early withdrawal.|Baseline and Visit 4 (Month 6)|The analysis was based on the Full Analysis Set (FAS) population. The FAS comprised participants who received at least 1 dose of Methotrexate + Etanercept, and completed at least 1 assessment following first dose.|||Joints||Standard Deviation|Mean
2662862|NCT01558089|Primary|Primary: Participants With EULAR (Good)|Good European League Against Rheumatism (EULAR) response at 6 months based on DAS28 EULAR response criteria defined as Good response = DAS28 change >1.2 with DAS28 ≤3.2; Moderate response = DAS28 change >0.6 with DAS28 >3.2-5.1; Non-response = DAS28 change ≤0.6 and absolute DAS28 >5.1|Visit 4 (Month 6)|Last observation carried forward (LOCF) was applied where data were available. Participants where a EULAR response value could not be calculated, were omitted from the analysis. Only 48 Participants had available EULAR response data at 6 months.|||participants|||Number
2662863|NCT01558063|Secondary|Change in Gamma-Amino Butyric Acid (GABA) Levels|The dose-response curve as it refers to ketamine inducing a dose-dependent increase in GABA levels measured with 1H Magnetic Resonance Spectroscopy (MRS) will be analyzed.|Baseline and 120 minutes after infusion|This data was not collected and therefore was not analyzed.||||||
2662864|NCT01558063|Secondary|Change in Glutamate Levels|The dose-response curve as it refers to ketamine inducing a dose-dependent increase in glutamate levels with 1H Magnetic Resonance Spectroscopy (MRS) will be analyzed.|Baseline and 120 minutes after infusion|The data was not collected at 120 minutes and therefore was not analyzed for this outcome measure.||||||
2662865|NCT01558063|Primary|Number of Responders 24-hours Post-ketamine Infusion|"The quantitative depressive symptom ratings were collected at Baseline, Day 1 (post ketamine), Day 3 using HDRS-24 (a 24-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery). The total score can range from 0 to a maximum score of 15 with a higher score indicating a worse outcome. A responder was defined as an individual exhibiting a reduction in the HDRS score from baseline to 24 hours (day 1) post-treatment, and all other individuals were classified as non-responders."|Day 1 (post ketamine)||||participants|||Number
2662866|NCT01557959|Secondary|Median Survival Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood||2 years||||Months||Standard Error|Median
2662867|NCT01557959|Secondary|Response Rate Among Subgroups of Patients According to Molecular Profiles Including Tumor Characteristics and Genetic Polymorphisms From Peripheral Blood|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Pre-specified that data is only presented for the subgroups Low Cyclin D1 and High Cyclin D1."|2 years||||Participants|||Count of Participants
2662868|NCT01557959|Primary|Time to Progression|Determined using RECIST. Estimated using the Kaplan-Meier method. Log-rank tests will be used to test for differences and Cox proportional hazards regression modeling will be used to adjust for patient demographics and characteristics such as smoking status at baseline (actively/non-actively smoking). Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|2 years||||months||95% Confidence Interval|Median
2663014|NCT01556763|Secondary|P50 Amplitude Difference|P50 auditory evoked potential response (amplitude measured in microvolts) using sensory gating paradigm. Measured by EEG as amplitude difference (conditioning stimulus minus test stimulus). Plotted on a scale of -0.2 to 0.8 microvolts. Normalization is suggested by a higher value.|Days -1 to 20|Subjects providing valid and measurable P50 responses.|||microvolts||Standard Error|Mean
2662869|NCT01557946|Secondary|Mean Difference From Baseline to Day 7 in Glutamine/Glutamate (Gln/Glu) Ratio Within Depressed Group|Estimated mean difference (day 7 minus baseline) in the glutamine/glutamate (Gln/Glu) ratio in the rostral anterior cingulate cortex as measured by proton magnetic resonance spectroscopy from baseline to day 7 of citalopram treatment within the depressed group. The change in metabolites from baseline to each time point was assessed by random regression analysis, adjusting for age and sex, using generalized estimating equations to account for the correlation of observations within individuals.|Change from baseline to day 7|One participant's day 7 scan was corrupted during data transfer and could not be recovered. Results are only presented for participants with depression as healthy control participants were only scanned once.|||arbitrary units||Standard Error|Mean
2662870|NCT01557946|Primary|Mean Difference From Baseline to Day 3 in Glutamine/Glutamate (Gln/Glu) Ratio Within Depressed Group|Estimated mean difference (day 3 minus baseline) in the glutamine/glutamate (Gln/Glu) ratio in the rostral anterior cingulate cortex as measured by proton magnetic resonance spectroscopy from baseline to day 3 of citalopram treatment within the depressed group. The change in metabolites from baseline to each time point was assessed by random regression analysis, adjusting for age and sex, using generalized estimating equations to account for the correlation of observations within individuals.|Change from Baseline to Day 3|One participant lacked a day 3 scan; one participant's day 3 scan was corrupted during data transfer and could not be recovered; and one participant's day 3 scan data was judged to be unusable due to poor spectral quality. Results are only presented for participants with depression as healthy control participants were only scanned once.|||arbitrary units||Standard Error|Mean
2662871|NCT01557920|Post-Hoc|Frequency of Spontaneous Swallows During Anesthesia vs Wakefulness|The number of swallows were counted during wakefulness and anesthesia. The frequency of swallowing was calculated per hour|swallows were measured during steady state conditions (mean±SEM, 2.6±0.6h)|224 swallows in 11 out of 12 subjects were analyzed (1 excluded due to faulty recording of swallows). If the pathological swallow incidence between sevoflurane and propofol anesthesia had a p-value >0.05, subsequent analyses were conducted to evaluate depth of anesthesia related differences rather than compound specific ones.|||number of swallows/hr||Standard Deviation|Mean
2662872|NCT01557920|Secondary|Duty Cycle|(T(ins)/T(total))*100|Will be measured before and during anesthesia until emergence from anesthesia, an expected average of 6 hours|In one subject we could not record high quality biologically plausible recordings of Duty cycle.|||percentage of Ttotal||Standard Deviation|Mean
2662873|NCT01557920|Secondary|Minute Ventilation (Tidal Volume and Respiratory Rate)|Measured by spirometry. Subjects wear a full-face mask. Reported in L/min|Will be measured before and during anesthesia until emergence from anesthesia, an expected average of 6 hours|In one subject we could not record high quality biologically plausible recordings of minute ventilation.|||L/min||Standard Deviation|Mean
2662874|NCT01557920|Secondary|Genioglossus Muscle Electromyogram|will be measured during steady state anesthesia as well as during carbon dioxide reversal, and during recovery from anesthesia.|participants will be followed for the duration of anesthesia until full recovery, an expected average of 9 hours|The number of participants in this group are only 9 since the genioglossus EMG signals were poor in 2 participants and these were excluded from the analysis.|||percentage of maximum recorded activity||Standard Error|Mean
2662875|NCT01557920|Secondary|Airway Diameter|Using acoustic pharyngometry, we intend to measure the cross-sectional area of the airway at several points during recovery from anesthesia.|participants will be followed for the duration of anesthesia until full recovery, an expected average of 9 hours|No data were obtained.||||||
2662876|NCT01557920|Primary|Proportion of Pathological Swallows|A pathological swallow was defined as a swallow that was followed by inspiratory flow. A physiological swallow was defined as a swallow that was followed by expiratory flow. The number of pathological and physiological swallows were measured during wakefulness and anesthesia. The pathological swallows are presented as percentage of path. swallows calculated as path.sw/[path.sw+phys.sw]*100 (%).|swallows were measured during steady state conditions (mean±SEM, 2.6±0.6h)|224 swallows in 11 out of 12 subjects were analyzed (1 excluded due to faulty recording of swallows).|||percentage of pathological swallows|||Number
2662877|NCT01557920|Primary|Upper Airway Closing Pressure|Upper airway closing pressure will be measured during steady state anesthesia as well as during carbon dioxide reversal.|participants will be followed for the duration of anesthesia, an expected average of 6 hours|Ten out of 12 subjects were analyzed. In two subjects we could not record high quality biologically plausible recordings of upper airway closing pressure. Data from multiple measurements per participant were combined to calculate an average upper airway closing pressure per subject.|||cm H20||Standard Deviation|Mean
2662878|NCT01557894|Secondary|Anxiety Sensitivity Index (ASI)|The Anxiety Sensitivity Index (ASI) is a 16-item questionnaire that measures the beliefs about the social and somatic consequences of anxiety symptoms. The total ASI score ranges from 0 to 64, with higher scores corresponding to greater anxiety sensitivity.|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)||||units on a scale||Standard Deviation|Mean
2662879|NCT01557894|Secondary|Attitude and Belief Scale-II (ABS-II)|"The Attitude and Belief Scale-II (ABS-II) measures rational and irrational thinking as described by Albert Ellis. The scale was designed to capture four cognitive processes (i.e., demandingness, awfulizing, low frustration tolerance, and self-downing/global evaluation) in three content areas (i.e., achievement, approval, and comfort). We selected the 72-item ABS-II because preliminary psychometrics are available for the Romanian population.~The total ABS-II score range from 0 to 360, with higher scores corresponding to greater irrationality."|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)||||units on a scale||Standard Deviation|Mean
2662880|NCT01557894|Secondary|Beck Depression Inventory-II (BDI-II)|"Beck Depression Inventory-II (BDI-II) is a 21-item self-report inventory widely used to assess DSM-IV depressive symptoms. Each item consists of four statements, scored 0-3, indicating increasing symptom severity.~Thus, for BDI-II the range of scores is 0-63, with higher scores reflecting higher levels of depression."|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)||||units on a scale||Standard Deviation|Mean
2663015|NCT01556763|Secondary|N100 Gating Ratio|N100 auditory evoked potential response (amplitude measured in microvolts) using the sensory gating paradigm. Measured by electroencephalography (EEG) as the amplitude ratio of test stimulus to conditioning stimulus. Plotted on a unitless scale of 0 to 2. Normalization is suggested by a lower value.|Days -1 to 20|Subjects providing valid and measurable N100 responses.|||ratio||Standard Error|Mean
2662881|NCT01557894|Primary|Social Phobia Inventory (SPIN)|"The Social Phobia Inventory (SPIN) is a brief (i.e., 17-item) self-report instrument measuring fear in social situations, avoidance of performance/social events, and physiological discomfort in social situations. Each item is rated on a 4-point scale.~Thus, for SPIN the range of scores is 0-68, with higher scores reflecting higher levels of social anxiety symptomatology"|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)||||units on a scale||Standard Deviation|Mean
2662882|NCT01557894|Primary|Leibowitz Social Anxiety Scale - Self Report (LSAS-SR)|"The Leibowitz Social Anxiety Scale - Self Report (LSAS-SR) measures social anxiety.~LSAS-SR presents 24 commonly anxiety-provoking situations, and asks participants to rate their fear and avoidance for each situation.~In order to obtain the total LSAS-SR score the Anxiety and Avoidance subscales scores are added together.~The LSAS-SR total score ranges from 0-144, with higher scores corresponding to greater social anxiety"|pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)||||units on a scale||Standard Deviation|Mean
2662883|NCT01557881|Primary|Comparison of Quality Scores (PET/CT vs PET/MRI), Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.|A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test.|After PET/MRI|Not available because data not collected.||||||
2662884|NCT01557881|Primary|Individual Quality Scores, Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.|A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test.|After PET/MRI|Not available because data not collected.||||||
2662885|NCT01557881|Primary|Standardized Uptake Value (SUV) on PET/CT Compared to PET/MRI|SUVs for various normal tissues such as liver, cardiac blood pool, and bone will be used. Selected lesions will be assessed as well. Maximum and mean SUVs will be measured for each imaging device. The SUVs and tumor/background ratios will be measured.|After PET/MRI|Not available because SUV data not collected.||||||
2662886|NCT01557868|Secondary|Visual Analogue Scale (VAS) at 6 Months|The VAS is a patient-reported assessment of knee pain. Patients mark on a line (0-100mm) their current level of knee pain while moving where 0 represent no pain and 100 represents maximum pain. We report changes in VAS pain rating between baseline and 6 month follow-up. Therefore scores can theoretically range from -100 (moving from maximum pain to no pain) to 100 (moving from no pain to maximum pain). Negative change scores represent decreases in perceived pain or improvement.|Assessments were at baseline to 6 month follow-up|The discrepancy between the number of subjects included in this analysis (140) and the number of subjects reported completing the study (141) is due to a missing values for one subject for this variable.|||units on a scale||Standard Deviation|Mean
2662887|NCT01557868|Primary|Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Scale|"The KOOS is 42-item patient-report questionnaire that assesses symptoms and problems associated with knee injury and osteoarthritis. It yields scores for five scales including Pain, Other Symptoms, Function in Daily Living, Function in Sport/Recreation, and Knee-Related Quality of Life. We used only the Pain scale which has a range of 0 to 100 where 100 represents the best score, i.e., no pain. We reported differences in baseline Pain scale score from Pain scale score at 6 months so these scores could theoretically range from -100 (moving from no pain to maximum pain) to 100 (moving from maximum pain to no pain). Positive change scores represent improvement from baseline."|Baseline and at 6 month follow-up||||units on a scale||Standard Deviation|Mean
2662888|NCT01557842|Primary|Cardiac-related Death|Subjects with cardiac-related death|2 years follow up|All enrolled subjects|||percentage of participants|||Number
2662889|NCT01557842|Primary|Percentage of Subjects Who Had Hospitalization for Ventricular Tachycardia (VT) Related Causes/Events|The hospital admission date must occur after completing the 1-month follow-up visit for the event to be considered an effectiveness failure.|From one month to 2 years follow up|All enrolled subjects|||percentage of participants|||Number
2662890|NCT01557790|Primary|Number of Serious Adverse Events||5 years||||Participants|||Count of Participants
2662891|NCT01557751|Primary|NRS-Pain With Movement on POD 2|"The primary endpoint is the pain reported by subjects, using the NRS-Pain with movement on the second day after surgery.The assumption behind this study is that certain genetic variants (e.g. single-nucleotide polymorphism (SNP) are responsible for part of total variation of certain clinical phenotypes (e.g. post-operative pain here).~Numeric Rating Score Pain Assessment (0-10 scale where 0 indicates no pain at all and 10 indicates the worst pain imaginable) on Post Op Day 2, Pain with Movement"|Postoperative day (POD) 2||||units on a scale||Full Range|Mean
2662892|NCT01557699|Secondary|Geometric Mean Titre (GMT) by PRNT on Day -7, 28 and 84|Geometric Mean Titre by Plaque Reduction Neutralization Test were assessed on Day -7, 28 and 84 at CDC, Atlanta. Titers are expressed as IU/ml.|Day -7, Day 28 and Day 84|Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples.|||IU/ml||95% Confidence Interval|Geometric Mean
2662893|NCT01557699|Secondary|Geometric Mean Concentration (GMC) for Anti-Measles IgG Antibodies|Geometric Mean Concentration (GMC) for anti-Measles IgG antibodies were measured on Day -7, Day 28 and Day 84 by ELISA using Trinity ELISA Kits for Measles.|Day -7, Day 28 and Day 84|Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples.|||IU/ml||95% Confidence Interval|Geometric Mean
2662894|NCT01557699|Secondary|The Proportion of Subjects in Each Group With Seroconversion for PRNT|The proportion of subjects in each group who show a seroconversion for PRNT on Day 28 and Day 84 was assessed.|Day 28 and Day 84|Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples.|||percentage of participants|||Number
2663016|NCT01556763|Primary|EVP-6124 Half-life (T[1/2]), Patients on Paliperidone/Risperidone|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|Patients receiving paliperidone/risperidone for whom blood samples were available for analysis.|||hr||Standard Deviation|Mean
2662895|NCT01557699|Secondary|The Proportion of Subjects in Each Group With Seroconversion for Serum Anti-Measles IgG|The proportion of subjects in each group who show a seroconversion for serum anti-Measles IgG on Day 28 and Day 84 was assessed.|Day 28 and Day 84|Per Protocol Population was used for the Immunogenicity analysis which included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 blood samples.|||percentage of participants|||Number
2662896|NCT01557699|Secondary|The Proportion of Subjects in Each Group With Seroprotective Plaque-reduction Neutralization Test (PRNT) Titre|The proportion of subjects in each group with seroprotective plaque-reduction neutralization test (PRNT) titre on Day -7, Day 28 and Day 84 was assessed.|Day -7, Day 28 and Day 84|Per Protocol (PP) Population was used for the Immunogenicity analysis which included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 blood samples.|||percentage of participants|||Number
2662897|NCT01557699|Secondary|The Proportion of Subjects in Each Group With Seropositive Anti-Measles IgG Antibodies|The proportion of subjects in each group with seropositive anti-Measles IgG antibodies on Day -7, Day 28 and Day 84 was assessed.|Day -7, Day 28 and Day 84|Per Protocol (PP) Population was for the Immunogenicity analysis & included subjects who received a dose of the study vaccine and met all inclusion/ exclusion criteria and complied with study procedures as defined in the study protocol, did not show any major protocol violation and gave baseline (Day -7) and Day 28 immunogenicity blood samples.|||percentage of participants|||Number
2662898|NCT01557699|Primary|Incidence of Serious Adverse Events (SAEs) and New Onset Chronic Medical Conditions|Incidence of serious adverse events (SAEs) and new onset chronic medical conditions throughout the entire study period of 180 days in each group was assessed.|Day 180|Intention-To-Treat (ITT) Population was used for safety and immunogenicity analysis. ITT population included subjects who had blood drawn to confirm a measles protective titer at Day -7 and met all inclusion/ exclusion criteria and did not receive a vaccine forbidden in the study protocol within the previous 30 days.|||participants|||Number
2662899|NCT01557699|Primary|Incidence of Unsolicited Adverse Events Within 84 Days|Incidence of unsolicited adverse events for a period of 84 days in each group was assessed.|Day 84|Intention-To-Treat (ITT) Population was used for safety analysis.|||participants|||Number
2662900|NCT01557699|Primary|Incidence of Solicited Reactions|Incidence of solicited local and systemic reactions within 14 days of vaccine administration in each group was assessed.|Day 14|Intention-To-Treat (ITT) Population included all subjects who received at least one dose of study vaccine and had at least one post-baseline assessment, regardless of whether they adhered to the study eligibility criteria or whether their study medication administration and study procedure visits are within the protocol-specified windows.|||participants|||Number
2662901|NCT01557595|Primary|Pittsburgh Sleep Quality Index (PSQI) at 2 Weeks After Baseline|"The PSQI is a validated self-rating instrument assessing aspects of sleep quality.Minimum score 0 (better); maximum score 21 (worse) < or = 5 associated with good sleep quality; > 5 associated with poor sleep quality. The PSQI is considered appropriate in identifying new-onset insomnia in the clinical setting."|2 weeks post baseline||||units on a scale||Standard Deviation|Mean
2662902|NCT01557582|Secondary|Intra-Observer Variability|Intra-Observer Variation: Directional Difference within Observer (Reading 2-Reading 1)|VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.||||Percent difference||Standard Deviation|Mean
2662903|NCT01557582|Secondary|Inter-Observer Variability|A VMS/echo inter-observer analysis of VMS between-Observer Variation for N=75 Studies.|VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.|All evaluable subjects.|||Percent difference||Standard Deviation|Mean
2662904|NCT01557582|Primary|Observed Mean (Std Err) for % Difference Between VMS and MRI.|% Difference was measured for right ventricular EDV, ESV and EF.|VMS occured on day 1 and required 15 minutes and MRI occurred on day 1 and required 1 hour.|Only evaluable participants were analyzed|||Percent difference||Standard Error|Mean
2662905|NCT01557569|Primary|Time Till Relapse|The number of days until a participant has a relapse, which will be measured by qualitative urine drug screens. To ensure a large enough sample, those who drop out prior to completing the residential stay will be included in this analysis (with minus days until relapse)|57 days|Only 4 of 13 finished the 2-week residential stay. Since subjects who drop out are deemed relapsed, all subjects receiving >/=1 dose of study med were included in the analyses. Those who dropped out before completing the residential stay were considered relapsed by the second day and the date of discharge was subtracted from this relapse date.|||Days to Relapse||Full Range|Median
2662906|NCT01557517|Secondary|Area Under the Plasma Concentration vs Time Curve for All Time Points|Steady-state pharmacokinetics of systemic clobetasol were assessed following a single 2 min oral rinse of 0.05% clobetasol on day 14 (1 patient collected on day 12). A noncompartmental pharmacokinetic assessment was performed using WinNonlin v5 (Pharsight Corp, Mountain View, CA) from three sampling times (pre-rinse, 15-45 min post-rinse, and 90-120 min post-rinse). Plasma concentrations of clobetasol were measured using a newly designed and validated LC-MS/MS assay, with a lower limit of quantification of 0.05 ng/mL. The maximum plasma concentrations (CMAX) were recorded as observed values and the area under the plasma-concentration time curve using all three sampling time points (AUCALL) was calculated using the Linear Trapezoidal rule.|pre-rinse, 15-45 min post-rinse, and 90-120 min post-rinse|Per protocol, pharmacokinetics testing was only done on the first 10 patients in the clobetasol group.|||Hr*ng/mL||Standard Deviation|Mean
2662915|NCT01557504|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an IMP, regardless of causal relationship and even if no IMP has been administered.|Up to 9 days|All participants as treated defined as all participants who received at least one dose of study drug.|||Participants|||Number
2662916|NCT01557504|Primary|Number of Participants Who Experienced an Abnormal Vital Sign Value|Vital sign measurements included blood pressure, heart rate, respiratory rate, and oral temperature.|Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)|All participants as treated defined as all participants who received at least one dose of study drug.|||Participants|||Number
2662907|NCT01557517|Secondary|Time to Maximum Plasma Concentration (Cmax) of Clobetasol|Steady-state pharmacokinetics of systemic clobetasol were assessed following a single 2 min oral rinse of 0.05% clobetasol on day 14 (1 patient collected on day 12). A noncompartmental pharmacokinetic assessment was performed using WinNonlin v5 (Pharsight Corp, Mountain View, CA) from three sampling times (pre-rinse, 15-45 min post-rinse, and 90-120 min post-rinse). Plasma concentrations of clobetasol were measured using a newly designed and validated LC-MS/MS assay, with a lower limit of quantification of 0.05 ng/mL. The maximum plasma concentrations (CMAX) were recorded as observed values and the area under the plasma-concentration time curve using all three sampling time points (AUCALL) was calculated using the Linear Trapezoidal rule.|pre-rinse, 15-45 min post-rinse, and 90-120 min post-rinse|Per protocol, pharmacokinetic testing was only done on the first 10 patients in the clobetasol group. We are reporting a calculation based on these 3 time points, not a number that can be reported at 3 discrete times.|||hours||Standard Deviation|Mean
2662908|NCT01557517|Secondary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 62 months and 12 days.|18/19 are analyzed in the Clobetasol arm/group because one participant declined participation before treatment started.|||Participants|||Count of Participants
2662909|NCT01557517|Secondary|Plasma Concentrations of Clobetasol Mouth Rinse in cGVHD Patients at Baseline (Day 0) and Day 28|Peripheral blood was drawn at baseline and day 28 of clobetasol rinse use, and clobetasol levels were measured in the blood sample. Plasma concentrations of clobetasol were measured using a validated LC-MS/MS assay with a lower limit of quantification of 0.05 ng/mL. Any values below detectable limit or with no peak were adjusted to 0.|Baseline Day 0 and Day 28|37/40 participants are included in this laboratory assessment as interpretable data was not available for 3 patient samples.|||ng/mL||Standard Deviation|Mean
2662910|NCT01557517|Secondary|Maximum Plasma Concentration (Cmax) of Clobetasol During Pharmacokinetic Testing|Steady-state pharmacokinetics of systemic clobetasol were assessed following a single 2 min oral rinse of 0.05% clobetasol on day 14 (1 patient collected on day 12). A noncompartmental pharmacokinetic assessment was performed using WinNonlin v5 (Pharsight Corp, Mountain View, CA) from three sampling times (pre-rinse, 15-45 min post-rinse, and 90-120 min post-rinse). Plasma concentrations of clobetasol were measured using a newly designed and validated LC-MS/MS assay, with a lower limit of quantification of 0.05 ng/mL. The maximum plasma concentrations (CMAX) were recorded as observed values and the area under the plasma-concentration time curve using all three sampling time points (AUCALL) was calculated using the Linear Trapezoidal rule.|pre-rinse, 15-45 min post-rinse, and 90-120 min post-rinse|Per protocol, pharmacokinetic testing was only done on the first 10 patients in the clobetasol group. We are reporting a calculation based on these 3 time points, not a number that can be reported at 3 discrete times.|||ng/mL||Standard Deviation|Mean
2662911|NCT01557517|Secondary|Percent Change in Participants' Raw Score of Oral cGVHD Related Dryness on a 0-10 Rating Scale|Oral cavity dryness was assessed by an oral cavity specific quality of life questionnaire. Dryness was rated based on a 0-10 rating scale on which subjects selected a single integer. 0 = no dryness and 10 = worst dryness. A negative value indicates an increase in patient-perceived oral dryness. A positive value indicates an improvement in patient-perceived oral dryness.|Baseline and 4 weeks on active treatment|18/19 are analyzed in the Clobetasol grp because one participant declined participation before treatment started.|||Percent change||Standard Deviation|Mean
2662912|NCT01557517|Secondary|Percent Change in Participants' Raw Score of Oral cGVHD Related Sensitivity on a 0-10 Rating Scale|Oral cavity sensitivity was assessed by an oral cavity specific quality of life questionnaire. Sensitivity was rated based on a 0-10 rating scale on which subjects selected a single integer. 0 = no sensitivity and 10 = worst sensitivity. A negative value indicates an increase in oral sensitivity. A positive value indicates an improvement in patient-perceived oral sensitivity.|Baseline and 4 weeks on active treatment|18/19 are analyzed in the Clobetasol grp because one participant declined participation before treatment started.|||Percent change||Standard Deviation|Mean
2662913|NCT01557517|Secondary|Percent Change in Participants' Raw Score of Oral cGVHD Related Pain on a 0-10 Rating Scale|Oral cavity pain was assessed by an oral cavity specific quality of life questionnaire. Pain was rated based on a 0-10 rating scale on which subjects selected a single integer. 0 = no pain and 10 = worst pain. A negative value indicates an increase in oral pain. A positive value indicates an improvement in patient-perceived oral pain.|Baseline to Day 14 and baseline to Day 28|18/19 are analyzed in the Clobetasol grp because one participant declined participation before treatment started. Clobetasol and Placebo grps were not assessed separately at Day 28. Only those pts who completed 4 wks of active clobetasol treatment and did not have an active oral infection at the 4 week timepoint were included in the final analysis.|||Percent change||Standard Deviation|Mean
2662914|NCT01557517|Primary|Percentage of Participants With a Response as Assessed by the 273-point Oral Mucositis Rating Scale (OMRS) Who Received Topical Clobetasol 0.05% Oral Rinse for Oral Chronic Graft-versus-host-disease (cGVHD) During a Four-week Treatment Period|Mucosal changes were assessed by the Oral Mucositis Rating Scale. The primary endpoint was evaluated using the OMRS. Oral tissue changes are rated on a scale of 0-3 compared with normal oral tissue (0-normal/no change, 1-mild change, 2-moderate change, and 3-severe change). Total score is the sum of all OMRS items with a possible range of 0. Total score is the sum of all OMRS items with a possible range of 0-273. Lower score=more normal oral mucosa. There is no standard definition of response in this field. Definitions we used in this pilot study to grade the response to study intervention are: Progress of 25% of initial score (rounded to the closest number) on the OMRS scale. Completion (PD) is defined as an increase of 25% of initial score (rounded to the closest number). Partial Response (PR) is defined as a decrease Response (CR) is defined as a PR plus a score of 0 on the erythema and ulceration components. Stable Disease (SD) does not meet criteria for progression or response.|At 4 weeks on active treatment|18/19 are analyzed in the Clobetasol arm/group because one participant declined participation before treatment started.|||percentage of participants|||Number
2662917|NCT01557504|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.|Up to 23 days (including approximately 10 to 14 days after the last dose of study drug)|All participants as treated defined as all participants who received at least one dose of study drug.|||Participants|||Number
2662918|NCT01557504|Primary|Apparent Terminal Half Life (t1/2) of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Owing to resumption of therapeutic metformin administration 24 hours after sitagliptin/metformin XR administration for all participants, metformin pharmacokinetic analyses were restricted to Cmax, Tmax and AUC0-24hr. Therefore, metformin arm is not included in this outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.|||Hour||Geometric Coefficient of Variation|Geometric Mean
2662919|NCT01557504|Primary|Tmax of Sitagliptin and Metformin Following Single Dose Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.|||Hour||Full Range|Median
2662920|NCT01557504|Primary|Cmax of Metformin Following Single Dose Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Due different units of measure for sitagliptin and metformin, sitagliptin data are presented in another outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2662921|NCT01557504|Primary|Cmax of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR|Due different units of measure for sitagliptin and metformin, metformin data are presented in another outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.|||nM||Geometric Coefficient of Variation|Geometric Mean
2662922|NCT01557504|Primary|Area Under the Curve 0 to Infinity (AUC 0-∞) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Owing to resumption of therapeutic metformin administration 24 hours after sitagliptin/metformin XR administration for all participants, metformin pharmacokinetic analyses were restricted to Cmax, Tmax and AUC0-24hr. Therefore, metformin arm is not included in this outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
2662923|NCT01557504|Primary|AUC 0-24 of Metformin Following Single Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hours post study drug administration. Due different units of measure for sitagliptin and metformin, sitagliptin data are presented in another outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.|||nM*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2662924|NCT01557504|Primary|AUC 0-24 of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR|Due different units of measure for sitagliptin and metformin, metformin data are presented in another outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
2662925|NCT01557504|Primary|Area Under the Curve 0 to Last (AUC 0-last) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR|In this study, metformin products were withheld 24 hours (hrs) prior to sitagliptin/metformin XR administration and were permitted to re-initiate 24 hrs post study drug administration. Owing to resumption of therapeutic metformin administration 24 hrs after sitagliptin/metformin XR administration for all participants, metformin pharmacokinetic analyses were restricted to maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax) and area under the curve 0 to 24 hrs (AUC0-24hr). Therefore, metformin arm is not included in this outcome measure.|Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose|Per protocol population defined as all participants who completed at least one period of treatment and had available data.|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
2662926|NCT01557504|Primary|Number of Participants Who Successfully Swallowed Study Med on Day 9|The Swallowing Ability Questionnaire was completed on Day 9 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.|Day 9|Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 9, all participants received matching placebo, so the two treatment groups were pooled on Day 9.|||Participants|||Number
2662936|NCT01557348|Secondary|Percentage of Participants Who Remained on Their Second Biologic Therapy at Months 6 and 12 After Start of Second Biologic Therapy|Percentage of participants who remained on their second biologic therapy at 6 and 12 months after start of second biologic therapy were reported.|Month 6 and Month 12|Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy (i.e,Treatment Group) and reason for changing biologic therapy was known.|||Percentage of participants|||Number
2662927|NCT01557504|Primary|Number of Participants Who Successfully Swallowed Study Med on Day 6|The Swallowing Ability Questionnaire was completed on Day 6 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.|Day 6|Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 6, all participants received matching placebo, so the two treatment groups were pooled on Day 6.|||Participants|||Number
2662928|NCT01557504|Primary|Number of Participants Who Successfully Swallowed Study Med on Day 4|The Swallowing Ability Questionnaire was completed on Day 4 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.|Day 4|Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 4, all participants received matching placebo, so the two treatment groups were pooled on Day 4.|||Participants|||Number
2662929|NCT01557504|Primary|Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2|The Swallowing Ability Questionnaire was completed on Day 2 after the participant received two matching placebo tablets (excluding marking) following consumption of a low- to moderate-fat meal in pediatric participants aged 10 to 17 years. The questionnaire consisted of five parts: could only swallow study med with help, easy to start swallowing study med, easy to swallow study med, felt like study med got stuck in throat, and had to swallow study med more than once. The number of participants who strongly agreed or agreed in each of the five parts is reported.|Day 2|Per protocol population defined as all participants who completed at least one period of treatment and had available data. On Day 2, all participants received matching placebo, so the two treatment groups were pooled on Day 2.|||Participants|||Number
2662930|NCT01557348|Secondary|Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi|The factors included participant characteristics and the reasons that led to the selection of second biologic therapy following an insufficient response or intolerance to a single previous TNFi. The participant characteristics included participant's option for treatment and option for follow-up. The other reasons included RA disease (rheumatoid factor [RF] and cyclic citrullinated peptide [CCP] status), primary failure, and new treatment characteristics (rapidity of action, route of administration, frequency of administration, low infectious risk, and no lymphoma risk). Participants were included in more than one of these factors.|Baseline|Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy and reason for changing biologic therapy was known.|||participants|||Number
2662931|NCT01557348|Secondary|Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy|The previous disease-modifying anti-rheumatic drugs therapy included auranofin, aurothioglucose, aurotioprol, azathioprine, chloroquine, ciclosporin, gold, hydroxychloroquine, infliximab, leflunomide, methotrexate, methotrexate sodium, minocycline, penicillamine, sodium aurothiomalate, sodium aurotiosulfate, sulfasalazine, and tiopronin. Number of participants with previous disease-modifying anti-rheumatic drugs therapy was reported.|Day 1 (Study entry visit)|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points are denoted as ‘n’.|||participants|||Number
2662932|NCT01557348|Secondary|Number of Participants With Previous TNFi Therapy|The previous TNFi therapy included adalimumab, etanercept, infliximab, and others (certolizumab, and golimumab). Number of participants with previous TNFi therapy history was reported.|Day 1 (Study entry visit)|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points are denoted as ‘n’.|||participants|||Number
2662933|NCT01557348|Secondary|Number of Participants With Reasons for Discontinuation of the First TNFi Therapy|The reasons for discontinuation of first TNFi therapy included inefficacy, intolerance and other reasons. The other reasons included complete remission and participants' non-compliance.|Day 1 (Study entry visit)|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis.|||participants|||Number
2662934|NCT01557348|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Event, Adverse Events Leading to Withdrawal, and Death|An Adverse event is defined as any unfavorable and unintended medical occurrence/sign (including an abnormal laboratory finding), symptom or disease in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.|Up to 12 Months|Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy and reason for changing biologic therapy was known.|||participants|||Number
2662935|NCT01557348|Secondary|Reasons for Stopping the Second Biologic Therapy and Subsequent Therapy Choice||Up to 12 months|Safety analysis population included all enrolled participants with only one previous TNFi whose second biologic therapy (ie,Treatment Group) and reason for changing biologic therapy was known.|||Number of participants|||Number
2662967|NCT01557322|Primary|Time Since Recalled Symptom Onset|RA symptoms include joint pain, stiffness, and swelling.|Baseline|Results not reported as this outcome was not evaluated due to lack availability of information on the outcome in BSRBR used for analysis.||||||
2662937|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Duration of Morning Stiffness at Months 6 and 12|Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. Participants with available data at the time of assessment were included in the analysis.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.|||minutes||Standard Error|Least Squares Mean
2662938|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Health Assessment Questionnaire-Disability Index at Months 6 and 12|Health Assessment Questionnaire-Disability Index (HAQ-DI) is participant reported assessment of ability to perform tasks in 8 categories of daily living activities as dress/groom, arise, eat, walk, reach, grip, hygiene, and common activities over past week. Each item was scored on a 4-point scale from 0 to 3, where 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible score range was 0-3, where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.|||scores on a scale||Standard Error|Least Squares Mean
2662939|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Participant's VAS Pain Score at Months 6 and 12|"Participants were asked to assess their pain intensity (severity of pain) on a 100-millimeter (mm) VAS with the left edge (0 mm) defined as no pain and the right edge (100 mm) defined as severest pain. Higher scores indicate worsening of disease."|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.|||mm||Standard Error|Least Squares Mean
2662940|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Patient Global Assessment of Disease at Months 6 and 12|Patient Global Assessment of Disease was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity. Higher scores indicate worsening of disease.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.|||mm||Standard Error|Least Squares Mean
2662941|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Physician Global Assessment of Disease at Months 6 and 12|Physician global assessment of disease was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity. Higher scores indicate worsening of disease.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.|||mm||Standard Error|Least Squares Mean
2662942|NCT01557348|Secondary|Least Squares Mean Change From Baseline in ESR at Months 6 and 12|The ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells sediment in a period of one hour. Normal range is 0-30 mm/hr. A reduction in the level of ESR is considered as an improvement in disease activity.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.|||mm/hr||Standard Error|Least Squares Mean
2662943|NCT01557348|Secondary|Least Squares Mean Change From Baseline in C-reactive Protein at Months 6 and 12|C-reactive protein (CRP) is an inflammation marker. Normal range is from 0-10 milligram/Liter. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in disease activity.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.|||milligram/Liter||Standard Error|Least Squares Mean
2662944|NCT01557348|Secondary|Least Squares Mean Change From Baseline in SJC at Months 6 and 12|The SJC is the most specific clinical method to quantify abnormalities in participants with RA. A total of 28 joints were assessed for swelling. Decrease in the score indicated improvement in disease activity.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.|||swollen joints||Standard Error|Least Squares Mean
2662945|NCT01557348|Secondary|Least Squares Mean Change From Baseline in TJC at Months 6 and 12|The TJC is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). A total of 28 joints were assessed for tenderness. Decrease in score indicated an improvement in disease activity.|Baseline, Month 6, and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis. Participants with available data at specified time points were analyzed and are denoted as ‘n’.|||tender joints||Standard Error|Least Squares Mean
2662968|NCT01557322|Primary|Time Since First Rheumatologist Visit||Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||years||Standard Error|Mean
2662946|NCT01557348|Secondary|Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month12|The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour [mm/hr]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity.|Baseline (Day of change in biologic therapy [<=Day 1]) and Month 12|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis.|||scores on a scale||Standard Error|Least Squares Mean
2662947|NCT01557348|Primary|Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month 6|The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour [mm/hr]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity.|Baseline (Day of change in biologic therapy [<=Day 1]) and Month 6|The primary effectiveness population included all participants who received at least one dose of a second biologic therapy at Baseline, had only one previous biologic therapy, and contributed to 24-week DAS28-ESR primary endpoint analysis.|||scores on a scale||Standard Error|Least Squares Mean
2662948|NCT01557322|Other Pre-specified|Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) at Month 6|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Month 6|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.||||||
2662949|NCT01557322|Other Pre-specified|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 6|The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). Total of 3 variables were analyzed (2 composite subscales and vitality score). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Month 6|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||units on a scale||Standard Error|Mean
2662950|NCT01557322|Other Pre-specified|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 6|Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 6|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Mean
2662951|NCT01557322|Other Pre-specified|Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 6|DAS28 calculated from the SJC and PJC using the 28 joints count, acute phase reactants (ESR, millimeters per hour or CRP, milligram per liter) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <2.6: remission, DAS28 <=3.2: low disease activity, DAS28 >3.2 to <=5.1: moderate disease activity, DAS28 >5.1: progression.|Baseline, Month 6|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||units on a scale||Standard Error|Mean
2662952|NCT01557322|Other Pre-specified|Number of Participants Who Died or Hospitalized Due to Adverse Events|Number of participants who died or hospitalized due to AEs is reported by each follow-up time point up to Month 60.|Month 6, 12, 18, 24, 30, 36, 48, 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable for specified category for each treatment arm, respectively.|||participants|||Number
2662953|NCT01557322|Other Pre-specified|Number of Participants With Malignancy|Malignancy included lymphoproliferative tumors, Hodgkins lymphoma, myeloma, leukaemia, non-melanoma skin cancer, and solid tumor. Number of participants with each of these malignancies is reported by each follow-up time point up to Month 60.|Month 6, 12, 18, 24, 30, 36, 48, 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable for specified category for each treatment arm, respectively.|||participants|||Number
2662954|NCT01557322|Other Pre-specified|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs is reported by each follow-up time point up to Month 60.|Month 6, 12, 18, 24, 30, 36, 48, 60|Analysis population included all enrolled participants with moderate RA at baseline.|||participants|||Number
2662969|NCT01557322|Primary|Duration of Disease (Rheumatoid Arthritis)||Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||years||Standard Error|Mean
2662955|NCT01557322|Primary|Direct and Indirect Cost of Rheumatoid Arthritis (RA) Treatment|Direct costs included: outpatient costs, physician visits, outpatient surgery, emergency room visits, visits to healthcare professionals other than physicians, medications, diagnostic and/or therapeutic procedures, medical devices, inpatient costs, admission to acute-care nonsurgical departments, admission to acute-care surgical departments, admission to extended-care facilities, and other direct costs (travel expenses, home care, home remodeling, medical devices, non-physician healthcare professionals, alternative medicine practitioner, participant time). Indirect cost (related to lost productivity through morbidity and death) included: lost productivity in employed participants (disability, sick-leaves), lost opportunities (lost productivity in family members caring for the patient, disability requiring changes to everyday activities), and lost wages.|Baseline|Results not reported as this outcome was not evaluated due to lack of availability of information on the outcome in BSRBR used for analysis.||||||
2662956|NCT01557322|Primary|Number of Rheumatoid Arthritis (RA) Related Visits|Number of RA-related visits to doctor/healthcare professional in previous 3 months was to be reported.|Baseline|Results not reported as this outcome was not evaluated due to lack of availability of information on the outcome in BSRBR used for analysis.||||||
2662957|NCT01557322|Primary|Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 60|ACR70 response: >=70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 60|Result not reported as no participants were evaluable at this time-point.||||||
2662958|NCT01557322|Primary|Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 60|ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.|Month 60|Result not reported as no participants were evaluable at this time-point.||||||
2662959|NCT01557322|Primary|Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 60|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Month 60|Result not reported as no participants were evaluable at this time-point.||||||
2662960|NCT01557322|Primary|Change From Baseline in Pain Visual Analog Scale (VAS) Score at Month 60|The pain VAS is a horizontal line; 100 millimeter (mm) in length, self-administered by the participant to rate pain from 0 mm (no pain) to 100 mm (worst possible pain).Change = mean scores at observation minus mean scores at baseline.|Baseline, Month 60|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.||||||
2662961|NCT01557322|Primary|Time to Therapeutic Goal|Therapeutic goal achievement was based on physician's discretion.|Baseline up to Month 60|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.||||||
2662962|NCT01557322|Primary|Time to Disease Worsening|Disease worsening (severe RA diagnosis) was defined as DAS28 score >5.1.|Baseline up to Month 60|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.||||||
2662963|NCT01557322|Primary|Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) at Month 60|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.|Baseline, Month 60|Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.||||||
2662964|NCT01557322|Primary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 60|The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). Total of 3 variables were analyzed (2 composite subscales and vitality score). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||units on a scale||Standard Error|Mean
2662965|NCT01557322|Primary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 60|Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||units on a scale||Standard Error|Mean
2662966|NCT01557322|Primary|Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs)|Number of participants who previously received DMARDs or were currently on DMARDs at baseline is reported.|Baseline|Analysis population included all enrolled participants with moderate RA at baseline.|||participants|||Number
2662970|NCT01557322|Primary|Change From Baseline in Patient's Global Assessment (PtGA) of Disease Activity at Month 60|"Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||mm||Standard Error|Mean
2662971|NCT01557322|Primary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 60|ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||mm/hour||Standard Error|Mean
2662972|NCT01557322|Primary|Change From Baseline in C-Reactive Protein (CRP) Level at Month 60|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. Normal range of CRP is <10 milligram/liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||mg/L||Standard Error|Mean
2662973|NCT01557322|Primary|Change From Baseline in Swollen Joints Count (SJC) at Month 60|Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||swollen joints||Standard Error|Mean
2662974|NCT01557322|Primary|Change From Baseline in Tender Joints Count (TJC) at Month 60|Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||tender joints||Standard Error|Mean
2662975|NCT01557322|Primary|Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 60|DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, acute phase reactants (erythrocyte sedimentation rate [ESR, millimeters per hour] or C-reactive protein [CRP, milligram per liter]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <2.6: remission, DAS28 <=3.2: low disease activity, DAS28 >3.2 to <=5.1: moderate disease activity, DAS28 >5.1: progression.|Baseline, Month 60|Analysis population included all enrolled participants with moderate RA at baseline. Here “n” signifies participants evaluable at each time-point for each treatment arm, respectively.|||units on a scale||Standard Error|Mean
2662976|NCT01557322|Primary|Blood Pressure (BP)|BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).|Baseline|"Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable for specified category for each treatment arm, respectively."|||millimeter of mercury (mmHg)||Standard Error|Mean
2662977|NCT01557322|Primary|Body Mass Index (BMI)|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2).|Baseline|"Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure."|||kg/m^2||Standard Error|Mean
2662978|NCT01557322|Primary|Number of Participants With Comorbidities|Comorbidities included: hypertension, moderate or severe heart failure, angina, stroke, epilepsy, asthma, chronic bronchitis/emphysema, peptic ulcer, tuberculosis, pre-existing or recent onset of central nervous system demyelinating disorders, chronic infectious disease such as chronic renal infection, chronic chest infection with bronchiectasis or sinusitis, active tuberculosis, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease, malignancy or history of malignancy, hyperthyroidism, depression and/or anxiety, recent substance abuse (drug or alcohol), human immunodeficiency virus (HIV) infection or active hepatitis B/C infection (including associated chronic active hepatitis). Participants suffering from any of the comorbidity are reported.|Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable for specified category for each treatment arm, respectively.|||participants|||Number
2662979|NCT01557322|Primary|Number of Participants With Chest X-Ray Prior to New Therapy||Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2662991|NCT01557166|Secondary|Change From Baseline in Fasting Plasma Glucose|Observed mean change from baseline in fasting plasma glucose (mmol/L) after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) - included all randomised subjects. 355 subjects contributed to the statistical analysis.|||mmol/L||Standard Deviation|Mean
2662980|NCT01557322|Primary|Number of Participants With Prior Joint Replacement or Surgery|Participants who had prior total knee replacement, total hip replacement, total shoulder replacement, total elbow replacement, wrist/hand/ankle/foot surgery, and neck surgery are reported.|Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2662981|NCT01557322|Primary|Number of Participants With Systemic Features|Systemic features included sicca syndrome, serosal involvement (pleurisy/pericarditis), eye involvement, systemic vasculitis, nailfold vasculitis, pulmonary fibrosis, and others (other than those specified).|Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure and “n” signifies participants evaluable for specified category for each treatment arm, respectively.|||participants|||Number
2662982|NCT01557322|Primary|Number of Participants With American College of Rheumatology (ACR) Criteria|ACR criteria: 1) Morning stiffness: in and around joints, lasting at least (>=) 1 hour; 2) Arthritis/deformity of >=3 joint areas: presence of soft tissue swelling or fluid (not bony overgrowth alone), 14 possible areas are right/left proximal interphalangeal (PIP), metacarpophalangeal (MCP), wrist, elbow, knee, ankle, metatarsophalangeal (MTP) joints; 3) Arthritis of hand joints: >=1 area swollen in wrist, MCP, PIP joint; 4) Symmetric arthritis: simultaneous involvement of same joint areas (as defined in 2) on both sides of body; 5): Rheumatoid nodules: subcutaneous nodules over bony prominences or extensor surfaces or in juxtaarticular regions; 6): Rheumatoid factor (RF): abnormal amounts of RF by any method for which result has been positive in <5% of normal control participants; 7) Radiographic changes: typical of RA on posteroanterior hand and wrist radiographs, which must include erosions/unequivocal bony decalcification localized in or most marked adjacent to involved joints.|Baseline|Analysis population included all enrolled participants with moderate RA at baseline. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2662983|NCT01557283|Other Pre-specified|Number of Participants Who Received Intermittent Treatment|Number of participants who received etanercept treatment in cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
2662984|NCT01557283|Other Pre-specified|Number of Participants Who Received Continuous Treatment|Number of participants who were treated continuously with etanercept without any treatment discontinuation as per dermatologist's discretion was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure.|||participants|||Number
2662985|NCT01557283|Secondary|Number of Participants With Reasons for Treatmant Discontinuation|Number of participants who discontinued etanercept before completing the study was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol.|||participants|||Number
2662986|NCT01557283|Secondary|Percentage of Body Surface Area (BSA) Affected by Psoriasis|Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb = 1 percent (%) of total BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck = 10% (10 palms), upper extremities = 20% (20 palms), Trunk (axillae and groin) = 30% (30 palms), lower extremities (buttocks) = 40% (40 palms)]. The total BSA affected was the summation of individual regions affected.|Start and end of cycle 1, 2, 3|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. 'N' (number of participants analyzed) signifies participants evaluable for this measure; ‘n’ signifies participants evaluable for this measure at specified time points.|||percentage of BSA||Standard Deviation|Mean
2662987|NCT01557283|Secondary|Psoriasis Area and Severity Index (PASI) Score|Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, and legs. For each section, percent (%) area of skin involved was estimated: 0 = 0%, 1 = less than (<) 10%, 2 = 10 to <30%, 3 = 30 to <50%, 4 = 50 to <70%, 5= 70 to <90%, 6 = 90 to 100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0 = none to 4 = maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.|Start and end of cycle 1, 2, 3|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. 'N' (number of participants analyzed) signifies participants evaluable for this measure; ‘n’ signifies participants evaluable for this measure at specified time points.|||units on a scale||Standard Deviation|Mean
2662988|NCT01557283|Secondary|Number of Weeks of Off-Treatment|Total duration of time in weeks for which participants discontinued etanercept treatment was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol. Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure.|||weeks||Standard Deviation|Mean
2662989|NCT01557283|Primary|Number of Weeks of Etanercept Treatment|Average duration of time in weeks for treatment with etanercept was reported.|Baseline up to end of study (90 weeks)|Per protocol (PP) population included participants who completed at least 1 treatment cycle, for whom study conclusion was duly filled in, and who had not deviated from protocol.|||weeks||Standard Deviation|Mean
2662990|NCT01557166|Secondary|Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%)|Observed mean change from baseline in glycosylated haemoglobin (HbA1c) (%) after 32 weeks of treatment.|Week 0, week 32|Full analysis set (FAS) - included all randomised subjects. 345 subjects contributed to the statistical analysis|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2662993|NCT01557166|Primary|Change From Baseline in Apnoea-hypopnoea Index (AHI)|Observed mean change from baseline in AHI (events/hour) after 32 weeks of treatment. AHI (apnoea and hypopnoea events per hour of sleep) is a measure used for the diagnosis and severity classification of obstructive sleep apnoea. AHI severity category: none ≤4.9; mild 5.0−14.9; moderate 15.0−29.9; severe ≥30.0 events/hour.|Week 0, Week 32|Full analysis set (FAS) - included all randomised subjects. 334 subjects contributed to the statistical analysis.|||events/hour||Standard Deviation|Mean
2662994|NCT01556997|Secondary|Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Systolic Blood Pressure (SBP).||Day 0 to Day 42|The Analysis Population for the Secondary Outcome (Change from baseline to end of treatment in the mean seated trough cuff systolic blood pressure (SBP)) consists of the Intent-to-treat population for the study|||mmHg||Standard Deviation|Mean
2662995|NCT01556997|Primary|Change From Baseline to End of Treatment in the Mean Seated Trough Cuff Diastolic Blood Pressure (DBP).||Day 0 to Day 42|The Analysis Population for the Primary Outcome (Change from baseline to end of treatment in the mean seated trough cuff diastolic blood pressure (DBP)) consists of the Intent-to-treat population for the study|||mmHg||Standard Deviation|Mean
2662996|NCT01556932|Primary|The Change in Numeric Rating Scale in Self-reported Nausea From Baseline Minus 60 Minutes of Treatment.|"The outcome measure for change was calculated from value at baseline minus value at 60 minutes. Subjects were asked to rate their nausea on a 0 (no nausea) to 10 (worst possible nausea) scale. Subjects who were eligible were randomly assigned to two sequences: one sequence used ABH gel first and then placebo; and the other sequence used placebo first and then ABH gel. We assumed that there was no carry-over effect from the first treatment to the second. A paired t-test was used to compare if ABH gel is not better than the placebo gel. A repeated measure analysis was used to compare the two treatment sequences. This endpoint was chosen as the drug gel because it is typically used as a prn (as needed) gel in actual practice, when relief is needed in short order."|60 minutes after application|25 participants were consented, two subjects declined treatment, one expired subject. Two subjects refused to continue after first treatment and did not complete the second treatment. Only 20 patients were analyzed because of missing data not done by those two subjects on the second treatment.|||units on a scale||Standard Deviation|Mean
2662997|NCT01556906|Secondary|Absolute Change From Baseline in Linoleic Acid (LA)|Absolute Change From Baseline in LA|Baseline and 16 weeks of treatment|All patients treated|||mg/mL||Standard Deviation|Mean
2662998|NCT01556906|Secondary|Absolute Change From Baseline in Docosahexaenoic Acid (DHA)|Absolute Change From Baseline in DHA|Baseline and 16 weeks of treatment|All patients treated|||mg/mL||Standard Deviation|Mean
2662999|NCT01556906|Secondary|Absolute Change From Baseline in Eicosapentaenoic Acid (EPA)|Absolute Change From Baseline in EPA|Baseline and 16 weeks of treatment|All patients treated|||mg/mL||Standard Deviation|Mean
2663000|NCT01556906|Secondary|Absolute Change From Baseline in Alpha Linoleic Acid (ALA)|Absolute Change From Baseline in ALA|Baseline and 16 weeks of treatment|All patients treated|||mg/mL||Standard Deviation|Mean
2663001|NCT01556906|Secondary|Absolute Change From Baseline in Ratio of Vitamin E to Total Lipids|Absolute Change From Baseline in ratio of vitamin E to total lipids|Baseline and 16 weeks of treatment|All patients treated|||ratio||Standard Deviation|Mean
2663002|NCT01556906|Secondary|Absolute Change From Baseline in Vitamin D|Absolute Change From Baseline in Vitamin D|Baseline and 16 weeks of treatment|All patients treated|||nmol/L||Standard Deviation|Mean
2663003|NCT01556906|Secondary|Absolute Change From Baseline in Vitamin E|Absolute change from Baseline in vitamin E|Baseline and 16 weeks of treatment|All patients treated|||umol/L||Standard Deviation|Mean
2663004|NCT01556906|Secondary|Absolute Change From Baseline in Vitamin A|Absolute change from Baseline in vitamin A|Baseline and 16 weeks of treatment|All patients treated|||µmol/L||Standard Deviation|Mean
2663005|NCT01556906|Secondary|Absolute Change From Baseline in Carbon Monoxide Lung Diffusing Capacity (DLCO)(a Pulmonary Function Test)|Absolute change from Baseline in DLCO|Baseline and 16 weeks of treatment|All patients treated|||mL CO/min/mm Hg||Standard Deviation|Mean
2663006|NCT01556906|Secondary|Absolute Change From Baseline in Forced Expiratory Volume During 1 Second (FEV1)|Absolute change from Baseline in FEV1|Baseline and 16 weeks of treatment|All patients treated|||Liters||Standard Deviation|Mean
2663007|NCT01556906|Secondary|Absolute Change From Baseline in Hepatic Fat Percent|Absolute change from Baseline in hepatic fat percent|Baseline and 16 weeks of treatment|All patients treated|||percent of hapatic fat||Standard Deviation|Mean
2663008|NCT01556906|Secondary|Absolute Change From Baseline in Total Bilirubin|Absolute change from Baseline in total bilirubin|Baseline and 16 weeks of treatment|All patients treated|||mg/dL||Standard Deviation|Mean
2663009|NCT01556906|Secondary|Absolute Change From Baseline in Aspartate Aminotransferase (AST)|Absolute change from Baseline in AST|Baseline and 16 weeks of treatment|All patients treated|||U/L||Standard Deviation|Mean
2663010|NCT01556906|Secondary|Absolute Change From Baseline in Alanine Aminotransferase (ALT)|Absolute change from Baseline in ALT|Baseline and 16 weeks of treatment|All patients treated|||U/L||Standard Deviation|Mean
2663011|NCT01556906|Primary|LDL-C|Percent change in LDL-C compared to Baseline.|Up to 16 weeks of treatment comapred to Baseline|All patients treated|||percentage change in LDL-C||Standard Deviation|Mean
2663012|NCT01556763|Secondary|P300 Peak Amplitude|P300 auditory evoked potential response (amplitude in microvolts) using orienting paradigm. Measured by EEG and calculated as the peak amplitude over 250-500 msec following stimulus onset (rare stimulus minus frequent stimulus). Plotted on a scale of -0.4 to 1.2 microvolts. Normalization is suggested by a more positive value.|Days -1 to 20|Subjects providing valid and measurable P300 responses.|||microvolts||Standard Error|Mean
2663013|NCT01556763|Secondary|MMN Summed Amplitude|Mismatch negativity (MMN) auditory evoked potential response (amplitude in microvolts) using orienting paradigm. Measured by EEG and calculated as the voltage difference over 100-200 msec following stimulus onset (rare stimulus minus frequent stimulus). Plotted on a scale of -1.2 to 0.2 microvolts. Normalization is suggested by a more negative value.|Days -1 to 20|Subjects providing valid and measurable MMN responses.|||microvolts||Standard Error|Mean
2663017|NCT01556763|Primary|EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Paliperidone/Risperidone|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving paliperidone/risperidone.|||pg*hr/ml||Standard Deviation|Mean
2663021|NCT01556763|Primary|EVP-6124 Area Under the Curve (AUC[0-24 h]), Patients on Aripiprazole|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving aripiprazole.|||pg*hr/mL||Standard Deviation|Mean
2663022|NCT01556763|Primary|EVP-6124 Time to Maximum Concentration (Tmax), Patients on Aripiprazole|Blood samples for PK analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving aripiprazole.|||hr||Full Range|Median
2663023|NCT01556763|Primary|EVP-6124 Maximum Plasma Concentration (Cmax), Patients on Aripiprazole|Blood samples for pharmacokinetic (PK) analyses were taken before dosing with EVP-6124 on Days 1 and 21.|Days 1 and 21|All patients receiving aripiprazole.|||pg/mL||Standard Deviation|Mean
2663024|NCT01556763|Primary|Number of Participants With Serious and Non-serious Adverse Events Spontaneously Reported by Subject and/or Observed by Investigator.|Safety and tolerability was measured by number of reported adverse events (serious and non-serious) and repeated clinical evaluation of physical examinations, vital signs, 12-lead electrocardiogram (ECG), 24-hour continuous cardiac monitoring, and laboratory tests (hematology/blood chemistry/urinalysis).|Screening (Day -5 for continuous cardiac monitoring) to Day 22|All randomized patients who ingested at least one dose of study drug or placebo.|||participants|||Number
2663025|NCT01556724|Secondary|Number of Participants With Decreased Infusion Rates|Number of patient requiring decreased infusion rates decreased to 5 mL/hour due to increased motor blockade.|Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters)|Number of patient requiring decreased infusion rates.|||Participants|||Count of Participants
2663026|NCT01556724|Secondary|Number of Participants With Increased Infusion Rates|Number of patients requiring increased infusion rates to 9 mL/hour to better optimize pain control.|Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters)|The number of participants with requiring increased infusion rates.|||Participants|||Count of Participants
2663027|NCT01556724|Secondary|Numeric Rating Scale Pain Score With Movement at 24 Hours|Numeric rating scale (NRS) pain score with movement were assessed at 24 hours. Pain scores were followed using an 11-point NRS (0 = no pain and 10 = worst imaginable pain). Scores at 24 hours were not averaged with any other scores.|24 hours postoperatively|NRS pain scores at 24 hours postoperatively at rest and in movement.|||units on a scale||95% Confidence Interval|Median
2663028|NCT01556724|Secondary|Patient Satisfaction With Pain Control|Patient satisfaction with pain control at 24 hours (0-10 scale). Patients' satisfaction was assessed using an 11-point numeric scale (0-10, 0 = unsatisfied and 10 = very satisfied). Scores at 24 hours were not averaged with any other scores.|24 hours postoperatively|Patient satisfaction with pain control at 24 hours.|||units on a scale||95% Confidence Interval|Median
2663029|NCT01556724|Primary|Opiate Consumption Postoperatively|Postoperative opiate consumption at 24 hours|24 hours postoperatively|Forty-one patients signed informed consent and underwent primary THA. Eleven patients were excluded: six for inability to achieve <0.5mA quadriceps stimulation for lumbar plexus block and five for general anesthesia. The study was completed after pharmacy randomization 30 patients: 16 in 0.2% and 14 in 0.1% group.|||mg||95% Confidence Interval|Mean
2663030|NCT01556633|Secondary|Number of Participants With Abnormal Shifts in Vital Signs|"Vital signs included pulse rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), and body temperature.~Vital sign with abnormal shifts from normal at baseline to high or low at post-baseline time points were recorded. Blood pressure was recorded in millimeter of mercury (mmHg), and temperature in degrees Celsius. Low blood pressure defined as <=70 mmHg (SBP) and <=40 mmHg (DBP); high blood pressure defined as >=140 mmHg (SBP) and >=90 mmHg (DBP); low temperature defined as <=36.5 degrees Celsius and high temperature defined as >=37.5 degrees Celsius."|Days 1 (post-dose), 2, 3, 4, 5, 6, 7, 8; and Follow-up visit (Days 15 to 22)|Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.|||participants|||Number
2663031|NCT01556633|Secondary|Number of Participants With Change From Baseline in Marked Abnormality in Electrocardiogram (ECG) Parameters at Follow-up Visit|ECG parameter included QT interval, QTcB interval and QTcF interval (all intervals are measured in millisecond [msec]). Marked abnormality in ECG is predefined for QT, QTcB, and QTcF interval as <=30, >30-60, and >60 msec increase from baseline.|From Baseline (Day -1) to Follow-up visit (Days 15 to 22)|Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.|||participants|||Number
2663032|NCT01556633|Secondary|Number of Participants With Marked Abnormality in Laboratory Measurements|"Laboratory analysis included: hematology (hemoglobin, hematocrit, reticulocyte, red blood cell, platelet and white blood cell count, mean corpuscular volume, mean corpuscular hemoglobin), prothrombin and activated partial thromboplastin time, biochemistry (sodium, potassium, bicarbonate, phosphate, chloride, calcium, urea, serum creatinine, bilirubin, cholesterol, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase [ALT], gamma-glutamyl transferase, protein, albumin, amylase, creatinine, lipase), random glucose, and urinalysis.~Laboratory test result values falling outside of the marked abnormality range that also represent a defined change from baseline were considered as marked laboratory abnormalities. A marked reference range for sodium is 130-150 millimole (mmol)/L, chloride is 95-115 mmol/L, phosphate is 0.75-1.60 mmol/L, calcium is 2-2.90 mmol/L, glucose is 2.8-11.10 mmol/L, bicarbonate is 18-28 mmol/L, and ALT is 0-110 Unit/L."|Approximately 7 weeks|Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.|||participants|||Number
2663033|NCT01556633|Primary|Renal Clearance (CLR) of Oseltamivir and Oseltamivir Carboxylate|CLR is calculated as the cumulative amount of drug excreted into urine from 0 to time t hours (Ae0-tlast) / area under the concentration-time curve from time zero through the last quantifiable concentration time (AUC0-t).|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose for blood; pre-dose and 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, and 144-168 hrs post-dose for urine.|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."|||L/h||Geometric Coefficient of Variation|Geometric Mean
2668502|NCT01505673|Secondary|Number of Daily Injections|The 3 days average of the number of daily injections performed within 3 consecutive days prior office visit 6 month.|6-months||||number/day||Standard Deviation|Mean
2663034|NCT01556633|Primary|Tmax and T1/2 of Oseltamivir and Oseltamivir Carboxylate|"The Time of observed maximum plasma concentration (Tmax) is defined as actual sampling time to reach maximum observed analyte concentration.~The Elimination Half-Life Period (T1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir."|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."|||h||Full Range|Median
2663035|NCT01556633|Primary|C120h, C168h and Clast of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose|"C120h is defined as the plasma concentration at 120 hours post-dose. C168h is defined as the plasma concentration at 168 hours post-dose. Clast is defined as the plasma concentration corresponding to the time of the last measureable (positive) plasma concentration.~Oseltamivir carboxylate is a clinically active metabolite of oseltamivir."|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis.|||ng/mL||Standard Deviation|Mean
2663036|NCT01556633|Primary|Cmax of Oseltamivir and Oseltamivir Carboxylate|The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2663037|NCT01556633|Primary|AUCinf of Oseltamivir and Oseltamivir Carboxylate for 30 mg Dose|AUCinf is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2663038|NCT01556633|Primary|AUC120, AUC168 and AUCinf of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose|AUC120 is defined as the area under the plasma concentration-time curve from time zero through 120 hours post-dose, AUC168 is defined as the area under the plasma concentration-time curve from time zero through 168 hours post-dose, and AUCinf is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity. Oseltamivir carboxylate is a clinically active metabolite of oseltamivir.|Pre-dose; 0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48, 72, 96, 120, 144, and 168 hrs post-dose|"PK population was used for this outcome measure. Only 9 participants were included, who did not significantly violate the inclusion/exclusion criteria, deviate significantly from protocol or with unavailable or incomplete data which influence PK analysis. Numbers of participants analyzed for the indicated drug/metabolite were denoted by n."|||nanogram (ng)*h/ milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
2663039|NCT01556633|Secondary|Number of Participants With Any Adverse Event (AEs) and Any Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with the intervention. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Approximately 7 weeks|Safety population: All participants who received the study drug, whether prematurely withdrawn from the study or not, were included.|||participants|||Number
2663040|NCT01556633|Primary|Total Dialysate Clearance for Automated Peritoneal Dialysis (CLDAPD) of Oseltamivir and Oseltamivir Carboxylate for 75 mg Dose|"CLDAPD is the total dialysate clearance for automated peritoneal dialysis, attributable to both continuous cycler-assisted peritoneal dialysis (CCPD) and continuous ambulatory peritoneal dialysis (CAPD), which was calculated with the recovery method over the dense blood sampling collection interval from 0 to 48 hours post-dose.~CLDAPD = the amount excreted into dialysate from 0 to 48 hours (Aed[0-48])/ plasma area under the concentration-time curve from time zero through 48 hours (AUC[0-48])~CLDCCPD = mean of CLDCCPD from the 2 CCPD sessions, calculated as CLDCCPD = (Aed[0-8]/AUC[0-8] + Aed[24-32]/AUC[24-32]) / 2~CLDCAPD = mean of CLDCAPD from the 3 CAPD sessions, calculated as CLDCAPD = (Aed[8-16]/AUC[8-16] + Aed[16-24]/AUC[16-24] + Aed[32-48]/AUC[32-48]) / 3"|CCPD: pre-dose (0)-2.67, 2.67-5.33, 5.33-8; CAPD: 8-16, 16-24; CCPD: 24-26.67, 26.67-29.33, 29.33-32; CAPD: 32-40, 40-48 hrs post-dose for urine; CCPD and CAPD:0.5, 1.33, 2, 2.5, 3, 4, 5, 6.67, 8, 10, 12, 14, 16, 20, 24, 28, 32, 48 hrs post-dose for blood|Pharmacokinetic (PK) population: Only 9 participants were included for this analysis as they did not significantly violate the inclusion or exclusion criteria, deviate significantly from the protocol or if data was unavailable or incomplete which influence the PK analysis were excluded from the PK analysis population.|||Litre (L)/hour (h)||Geometric Coefficient of Variation|Geometric Mean
2663041|NCT01556594|Secondary|Area Under the Curve (AUC0-last) of Baseline Adjusted Glucagon||Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration|Participants who received at least one dose of glucagon (SC Glucagon or NG) with available pharmacokinetic data.|||hour*picogram per millilitre (hr*pg/mL)||Standard Deviation|Mean
2663042|NCT01556594|Secondary|Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon||Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration|Participants who received at least one dose of glucagon (SC Glucagon or NG) with available pharmacokinetic data.|||hours (hr)||Full Range|Median
2663043|NCT01556594|Secondary|Maximum Change From Baseline Concentration (Cmax) of Glucagon||Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration|Participants who received at least one dose of glucagon (SC Glucagon or NG) with available pharmacokinetic data.|||picograms per millilitre (pg/mL)||Standard Deviation|Mean
2663044|NCT01556594|Secondary|Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose||Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration|Participants who received at least one dose of glucagon (SC Glucagon or NG).|||hours (hr)||Full Range|Median
2663045|NCT01556594|Secondary|Maximum Concentration (Cmax) of Baseline-Adjusted Glucose||Pre-dose; 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2.0, 2.5 and 3.0 hours after glucagon administration|Participants who received at least one dose of glucagon (SC Glucagon or NG).|||millimole per liter (mmol/L)||Standard Deviation|Mean
2663046|NCT01556594|Primary|Number of Participants With at Least One Adverse Event|Safety and tolerability evaluated through the assessment of adverse events. An AE was defined as any untoward medical occurrence in a clinical investigation subject administered the investigational product and which did not necessarily have a causal relationship with this treatment. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Within 3 hours post glucagon administration|Participants who received at least one dose of glucagon (SC Glucagon or NG).|||Participants|||Count of Participants
2663047|NCT01556594|Primary|Percentage of Responders|Participants with a blood glucose increment of ≥1.5 millimole per liter [mmol/L) within 15 of nadir (5 minutes post dose) and for at least 10 minutes following nadir.|Pre-dose; 30 minutes following glucagon administration|All enrolled participants.|||percentage of participants|||Number
2663048|NCT01556451|Primary|Percentage of Participants Discontinued Due to Clinical Adverse Experiences||Up to 42 days postvaccination|Safety population which included all vaccinated participants who had any safety follow-up|||Percentage of Participants|||Number
2663049|NCT01556451|Primary|Percentage of Participants With Clinical Adverse Experiences|An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.|Up to 42 days postvaccination|Safety population which included all vaccinated participants who had any safety follow-up|||Percentage of Participants|||Number
2663050|NCT01556451|Primary|Geometric Mean Titer (GMT) of VZV Antibody|Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a gpELISA to detect Immunoglobulin G antibody to VZV|Day 1 (Baseline) and 4 weeks postvaccination|The population analyzed included all participants who received Zoster Vaccine Live and were not excluded at the request of the Institutional Review Board and did not have major deviations from the protocol procedures|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2663051|NCT01556451|Primary|Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody|Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) to detect Immunoglobulin G antibody to VZV. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 4 postvaccination / Day 1 (Baseline).|Day 1 (Baseline) and Week 4 postvaccination|The population analyzed included all participants who received Zoster Vaccine Live and were not excluded at the request of the Institutional Review Board and did not have major deviations from the protocol procedures|||Ratio||95% Confidence Interval|Geometric Mean
2663052|NCT01556438|Secondary|Pharmacodynamics (PD): Change From Baseline in B-cell Subset Fractions|CD19+ peripheral B-cells counts are based on the percentage of total leukocyte population and absolute cell counts.|Baseline, Cycle 1 and Cycle 7: prior to first tabalumab dose.|All participants who received at least 1 dose of study drug and had evaluable PD. 300 mg tabalumab IV and SC dose were analyzed together.|||percentage of b-cell change||Standard Deviation|Mean
2663053|NCT01556438|Secondary|Pharmacodynamics (PD): Change From Baseline in Absolute B-cell Count||Baseline through study completion (up to 455 days)|Zero participants analyzed as no post baseline data collected.||||||
2663054|NCT01556438|Secondary|Time to Progression (TTP)|TTP is defined as the time from the date of study enrollment to the date of objectively determined progressive disease. TTP will be censored at the date of the last objective progression free disease assessment.|Baseline to date of Progressive Disease (up to 455 days)|All participants who received at least 1 dose of study drug and didn't have AEs . 300 mg tabalumab group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants. Participants that were censored prior to PD and not included in analysis:100 mg tabalumab n=4, 300 mg tabalumab n=8.|||months||Full Range|Median
2663055|NCT01556438|Secondary|Duration of Response (DoR)|DoR is defined as the time from the date when the measurement criteria are met for CR, CRu, or PR (whichever status is recorded first) until the date of first observation of measured progressive disease. For responding participants who die without progressive disease (including death from study disease),DoR will be censored at the date of death. For responding participants not known to have died as of the data cut-off date and who do not have progressive disease, DoR will be censored at the last objective progression-free assessment date prior to the data cut-off date.|Time from Response until measured Progressive Disease (up to 455 days)|All participants who received at least 1 dose of study drug, 4 participants were censored from Cohort 1 and 5 participants from Cohort 2. 300 mg tabalumab group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.|||months|||Number
2663056|NCT01556438|Secondary|Number of Participants With Tumor Response (Tumor Response Rate)|"Stringent Complete Response- Complete response in addition to normal free light chain ration and no clonal cells in bone marrow.~Complete Response- no monoclonal protein (mp) in blood, no serum or urine mp, less than 5% plasma cells in bone marrow.~Very Good Partial Response-more than 90% decrease in mp and urine protein. Partial Response- over 50% decrease in serum mp. Stable Disease- less than 25 percent decrease of monoclonal protein. Progressive Disease- 25% increase compared to lowest value of serum mp, urine mp, no measurable mp."|Baseline to disease progression (up to 421 days)|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2668503|NCT01505673|Secondary|Total Daily Insulin Dose|The 3 days average of the total daily dose of insulin used within 3 consecutive days prior office visit 6 month.|6-months||||IU||Inter-Quartile Range|Median
2663057|NCT01556438|Secondary|Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Tabalumab (LY2127399)||Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab|All participants who received at least 1 dose of any study drug and had evaluable PK data. Participants in the 300 mg tabalumab group may have received IV and SC BTZ and may be counted in the IV and SC group for analysis.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2663058|NCT01556438|Secondary|Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Plasma Concentration (AUC0-tlast) of Tabalumab (LY2127399)||Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab|All participants who received at least 1 dose of any study drug and had evaluable PK data.|||hours times nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2663059|NCT01556438|Secondary|Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) for Tabalumab (LY2127399)||Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab|All participants who received at least 1 dose of any study drug and had evaluable PK data.|||microgram per milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2663060|NCT01556438|Primary|Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs|A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.|Baseline through 8 months|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2663061|NCT01556425|Secondary|Percent of Weekly Urine Samples Negative for Cocaine|Was the participant's urine sample negative for cocaine at each of the 24 weekly assessments scheduled after random assignment (Y/N)? The outcome measure was the percentage of weekly urine samples that was negative for cocaine.|24 weeks||||percentage of cocaine negative samples||Full Range|Mean
2663062|NCT01556425|Primary|Percent of Weekly Urine Samples Negative for Opiates|Was the participant's urine sample negative for opiates at each of the 24 weekly assessments scheduled after random assignment (Y/N)? The outcome measure was the percentage of weekly urine samples that was negative for opiates.|24 weeks||||percentage of negative urine samples||Full Range|Mean
2663063|NCT01556347|Secondary|Percentage of Patients Who Receive Transplants Who Then Suffer Serious Post-transplant Complications|Percentage of study patients who receive transplants within the study period who then experience death, allograft loss, hospitalization due to infection, and non-fatal serious adverse cardiac event (defined as acute myocardial infarction, congestive heart failure, need for percutaneous cardiac intervention, coronary artery bypass grafting, cardiac defibrillator placement, cerebral vascular accident, peripheral vascular disease) within 1 year of transplantation.|730 days|No patients were transplanted within the study period so no patients could be analyzed for these potential outcomes||||||
2663064|NCT01556347|Secondary|Percentage of Patients With a CPRA <20%, But Were Not Transplanted During the Study Period|Proportion of patients who achieve a Calculated Panel Reactive Antibody test CPRA of < 20%, but are not transplanted within the study period.|583 days|No patients met this criteria since no patient had a CPRA of less than 20%.||||||
2663065|NCT01556347|Secondary|The Percentage of Allografts That Endure Acute Rejection Within One Year of Transplantation|The percentage of allografts that have an acute rejection episode per the criteria of the International Society of Heart and Lung Transplantation (ISHLT) within one year of transplantation. Allografts implanted during the Recovery Phase are monitored for a year for acute rejection per the study protocol. An allograft potentially implanted on the last day of a patient's recovery period would still be monitored for a year, so the potential outcome measure time would be 730 days. Since no allografts were implanted during the recovery period, there are no results to report.|730 days|No patients met the criteria for this group. The one patient who received a transplant did not have the transplant during the study period, and she did not have signs of rejection at the time of her autopsy.||||||
2663066|NCT01556347|Secondary|Percentage of Allograft Survival|The percentage of allografts transplanted during the study period that survive to 6 and 12 months post transplant.|730 days|No patients received a transplant during the study period. The one patient who was transplanted outside of the study period did not survive to 6 months.||||Allografts||
2663067|NCT01556347|Secondary|Percentage of Patients Post-Transplant That Are DSA Negative|Percentage of patients who receive a transplant within the study period who are then DSA negative at 1 year following transplantation.|730 days|No patients were in this group||||||
2663068|NCT01556347|Secondary|Percentage of Patients Who Develop De Novo Alloantibody or DSA Alloantibody After Transplant|Percentage of patients who are transplanted with the study period who then develop de novo or donor-specific alloantibody (DSA) within one year post-transplant. The patients would be eligible for transplant after day 218 in the study protocol and the study had 365 days in which to be transplanted. If a patient was transplant on day 583,( the last day of eligibility), and then followed for one year, then the outcome time frame would be a total of two years. No patient was transplanted within the study period.|730 days|No patients met the criteria for this measure since the one patient eventually transplanted did not live long enough to develop donor specific antibodies.||||||
2663069|NCT01556347|Secondary|The Percentage of Patients With Antibody Mediated Rejection After Transplantation|The percentage of patients who experience antibody mediated rejection at 6 months and 1 year post transplant. The study period was 583 days, during which a patient was eligible for transplant during the last 365 days. If a patient was transplanted on day 583, then the patient is followed for one year after the transplant, then the total time to assess the two patients would have been a period of two years or 730 days. In fact, neither patient was transplanted within the study period.|730 days|No study patient met the criteria for this measure since no patients were transplanted during the study period. The one patient who was eventually transplanted did not live to 6 months after the transplant.||||||
2663070|NCT01556347|Primary|Percentage of Patients With Grade 4 Hematologic Toxicities|A Grade 4 hematologic toxicity includes a platelet count < 25,000/mm3 or an absolute neutrophil count < 500/mm3|583 days|The two patient who entered the study were evaluated|||Participants|||Count of Participants
2663071|NCT01556347|Primary|The Percentage of Patients Who Experience Exacerbations Cardiac Dysrhythmias or Heart Failure|The percentage of study patients who experience an exacerbation of cardiac dysrhythmias and heart failure during the study period|583 days|The two patients entered into the study were evaluated.|||Participants|||Count of Participants
2663072|NCT01556347|Primary|The Percentage of Patients Who Experience Either a Respiratory Tract Infection or a Urinary Tract Infection|The percentage of study patients who experience infectious complications in either the respiratory or urinary tracts during the study period.|583 days|The two patients who entered the study were evaluated|||Participants|||Count of Participants
2663073|NCT01556347|Primary|Percentage of Patients Who Experience CMV, PTLD, and PML|Percentage of patients who experience cytomegalovirus (CMV), post-transplant lymphoproliferative disease (PTLD), or progressive multifocal leukoencephalopathy (PML) during the study period.|583 days|The two patients who entered the study were evaluated.|||Participants|||Count of Participants
2663074|NCT01556347|Primary|The Percentage of Patients Who Experience Any Grade of Peripheral Neuropathy|The percentage of patients in the study who experience any grade of peripheral neuropathy during the study period|583 days|The two patients entered into the study were analyzed.|||Participants|||Count of Participants
2663075|NCT01556347|Primary|Percentage of Patients Who Experience Grade 3 and Above Non-Hematologic Toxicities|Percentage of patients who experience of grade 3 and above non-hematologic toxicities as measured by the incidence of hypersensitivity reaction, fever, nausea and vomiting or dehydration during the study period.|583 days|There were two patients entered into the study and both were analyzed.|||Participants|||Count of Participants
2663076|NCT01556347|Primary|Percentage of Patients Who Suffer Mortality, a Serious Adverse Event, or Other Adverse Event During the Study Period|Percentage of study patients who experience a serious safety issue during the three phases of the study as measured by all cause mortality, serious adverse reactions and other adverse reactions.|583 days|Two patients were entered into the study and both were analyzed|||Participants|||Count of Participants
2663077|NCT01556347|Primary|Percentage of Patients Transplanted|Percentage of patients, who are transplanted within one year of finishing the Bortezomib treatment phase.|365 days|The two patients who were entered into the study were analyzed.|||Participants|||Count of Participants
2663078|NCT01556347|Primary|Percentage of Patients With a Reduction in CPRA to Less Than 20%|Percentage of highly sensitized heart transplant candidates, (patients with a CPRA greater than 50%), who have desensitization therapy, and then achieve a reduction in alloantibody such that their CPRA falls below 20%. For an individual patient, the outcome measure time frame is the one year of the Recovery Phase which begins after 218 days from the time that the patient begins the Induction Immunotherapy Phase, which is the same as the end of the Bortezomib Treatment Phase.|365 days|There were two patients entered into the study and therefore two patients analyzed.|||Participants|||Count of Participants
2663079|NCT01556204|Secondary|Pain|Pain as estimated by endometriosis, Endometriosis Health Profile-30 (EHP-30). Score ranges from 0-100. Lower score denotes improvement. Pain: As score decreases, pain decreases. No subscales.|Baseline, 6-weeks, 6-months||||units on a scale||Standard Deviation|Mean
2663080|NCT01556204|Primary|Operative Time|Operative time is defined as skin incision to skin closure.|1st 24 hours||||minutes||Standard Deviation|Mean
2663081|NCT01556165|Secondary|Levodopa Administration Within 26 Weeks|It was stated in the statistical analysis plan (SAP) that if >10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, levodopa administration within 26 Weeks was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.|Baseline to Week 26|||||||
2663082|NCT01556165|Secondary|Time to Onset of Levodopa Therapy|It was stated in the statistical analysis plan (SAP) that if >10% of FAS patients were considered to have taken levodopa during the treatment period, the endpoint, time to onset of levodopa treatment was to be analysed. However, since only one patient (in the placebo group) had levodopa administered during the treatment period, this endpoint was not analysed, as had been defined a priori in the SAP.|Baseline to Week 26|||||||
2663083|NCT01556165|Secondary|Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III)|The Unified Parkinson's Disease Rating Scale (UPDRS) Part III evaluates motor function, it comprises 14 parts and the score ranges from 0 (normal) to 108 (severe impairement and disability)|Baseline to Week 26|The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.|||units on a scale||Standard Error|Mean
2663084|NCT01556165|Secondary|Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II)|The Unified Parkinson's Disease Rating Scale (UPDRS) Part II evaluates activities of daily living, it comprises 13 parts and the score ranges from 0 (normal) to 52 (severe impairement and disability)|Baseline to Week 26|The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.|||units on a scale||Standard Error|Mean
2663085|NCT01556165|Secondary|Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I)|The Unified Parkinson's Disease Rating Scale (UPDRS) Part I evaluates mentation, behaviour and mood symptoms, it comprises 4 parts and the score ranges from 0 (normal) to 16 (severe impairement)|Baseline to Week 26|The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.|||units on a scale||Standard Error|Mean
2663086|NCT01556165|Primary|Change From Baseline to Week 26 in UPDRS Total Score|The Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's disease-related disability and impairment. The scale comprises four parts: Part I evaluates mentation, behaviour, and mood symptoms; Part II evaluates activities of daily living (ADL); Part III evaluates motor function; and Part IV evaluates complications of dopaminergic therapy. The total score is the sum of the subscale scores for Parts I to III and ranges from 0 (no disability) to 176 (total dependence).|Baseline to Week 26|The full-analysis set (FAS) comprised all patients in the APTS who had a valid baseline assessment and at least one valid post-baseline assessment of the primary efficacy variable.|||units on a scale||Standard Error|Mean
2663125|NCT01555463|Secondary|Participants' Global Assessment of Treatment Response at End of Treatment|At the end of treatment, participants assessed the change of papulopustular rosacea from baseline (how it looked, felt, appeared to others) as excellent improvement, good improvement, fair improvement, no improvement, or worse. The number of participants in each category of this assessment is presented.|At end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.|||Participants|||Number
2663087|NCT01556100|Secondary|To Determine the Test/Retest 18F-DTBZ PET Measurements of Vesicular Monoamine Transporter II Binding in PD Patients.|"The test/retest reliability will be estimated from a subgroup of the study subjects (10 subjects) who receive additional scan within 4 weeks since baseline image.~In order to refine the definition of a positive 18F-DTBZ in patient with PD as compared to healthy control, quantitative measurement will be used. The standard uptake value (SUV) of each brain regions will be calculated. The SUV is a widely used, simple PET quantifier, calculated as a ratio of tissue radioactivity concentration (e.g. in units kBq/ml) at time t, CPET(t) and injected dose (e.g. in units MBq) at the time of injection divided by body weight (e.g. in units kg).SUV = CPET(t) / (Injected dose / Patient's weight), t =90min, and the unit of SUV is g/ml."|three years|A subgroup of 10 subjects receive additional scan for a test/retest reliability study|||g/mL||80% Confidence Interval|Mean
2663088|NCT01556100|Primary|Change in 18F-DTBZ Uptake in a Cohort of Parkinson's Disease Patients From Baseline to Month 36|To expand the database of 18F-DTBZ PET imaging in Parkinson's Disease patients to refine the definition of a positive scan in patient with PD.|three years||||SUVR||80% Confidence Interval|Mean
2663089|NCT01556061|Secondary|Second Laryngoscopy|A second laryngoscopy will be performed in patients with the video laryngoscope from the other group. Patients will be intubated after second laryngoscopy with with this same video laryngoscope.|30 seconds||||seconds||Inter-Quartile Range|Median
2663090|NCT01556061|Secondary|First Laryngoscopy|Patients underwent laryngoscopy first with their assigned randomized laryngoscope. Time measured was from the time from the moment the anesthesiologist had the laryngoscope in hand to time to optimal visualization of vocal cords.|30 seconds||||seconds||Inter-Quartile Range|Median
2663091|NCT01556061|Primary|Time for Intubation|Time taken for successful placement of endotracheal tube after a successful laryngoscopy. Typically a successful laryngoscopy will range from few seconds to no more than 90 seconds. A successful intubation will not range more than 90 seconds.|90 seconds|The unit of measure of time in seconds from D-MAC larynogoscopy to intubation in the (C-MAC Laryngoscopy First, Then DMAC Video Laryngoscopy) group and from C-MAC laryngoscopy to intubation in the (D-MAC Laryngoscopy First, Then C-MAC Video Laryngoscopy) group.|||seconds||Inter-Quartile Range|Median
2663092|NCT01555983|Primary|Number of Participants Achieving a Reduction in Pain Intensity of 30% or More|Number of participants achieving a reduction of pain intensity of 30% or more, a level believed to be clinically important, was estimated for each treatment dose.|hourly pain assessments for 8 hours||||participants|||Number
2663093|NCT01555931|Secondary|LNG-IUS Expulsion or Removal|Expulsion or indicated removal of the originally placed LNG-IUS at any point during the study|up to 6 months||||participants|||Number
2663094|NCT01555931|Primary|Breastfeeding|Reported any breastfeeding at the final 6 month visit|6 months||||participants|||Number
2663095|NCT01555762|Secondary|Percentage of Participants With Balducci Score|Balducci score defines an algorithm for the individual participant according to age, ADL and modified IADL 4-items scores, estimated performance status and comorbidities, particularly cardiovascular, cancer, depression or anemia. Balducci score is categorized in the following- Type 1 (Harmonious), Type 2 (Intermediate) and Type 3 (Frail). Type 1 indicates better results and Type 3 indicates worse outcomes.|Baseline, Month 6, 12, 24|The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in the study was collected for overall participants and not as per dose administered to participants.|||Percentage of participants|||Number
2663096|NCT01555762|Secondary|Lawton Instrumental Activities of Daily Living Score (IADL)|The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. The instrument is most useful for identifying how a participant is functioning at the present time and for identifying improvement or deterioration over time. There are 8 domains of function measured with the Lawton IADL scale (telephone use, shopping, cooking, housekeeping, laundry, mode of transportation, responsibility of own medications, and ability to handle finances). Participants are scored according to their level of functioning from 0 (low function, dependent) to 8 (high function, independent). Higher score for each domain represents better functional performance of the older people.|Baseline, Month 6, 12, 24|The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in the study was collected for overall participants and not as per dose administered to participants.|||units on a scale||Standard Deviation|Mean
2663097|NCT01555762|Secondary|Percentage of Participants With Activities of Daily Living (ADL)|The Katz Activity of Daily Living (ADL) questionnaire scale contains 6 items evaluating in terms of autonomy or dependence the patient's ability to carry out basic activities of daily living (bathing, dressing, toileting, transfer, continence, feeding). Total score range 0 (low) to 6 (high). High score indicates participant is independent.|Baseline, Month 6, 12, 24|The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in the study was collected for overall participants and not as per dose administered to participants.|||Percentage of participants|||Number
2663098|NCT01555762|Secondary|Percentage of Participants With Adverse Events (AEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|Up to 53 months|Safety population included all participants who had at least one infusion of bevacizumab. Data in the study was collected for overall participants and not as per dose administered to participants.|||Percentage of participants|||Number
2663099|NCT01555762|Secondary|Percentage of Participants With Bevacizumab Administration||Up to 36 months|The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation.|||Percentage of participants|||Number
2663196|NCT01554982|Other Pre-specified|Ferritin- Baseline||Baseline||||ng/mL||Standard Deviation|Mean
2663197|NCT01554982|Other Pre-specified|Serum Phosphorus- Week 48||48 weeks||||mg/dL||Standard Deviation|Mean
2663198|NCT01554982|Other Pre-specified|Serum Phosphorus- Baseline||Baseline||||mg/dL||Standard Deviation|Mean
2663100|NCT01555762|Secondary|Overall Survival|Overall survival was defined as the time between the treatment start date (date of the first infusion of bevacizumab) and date of all-cause death.|From the time of first dose of study treatment to the time of death from any cause (Up to 53 months)|The EFF included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in the study was collected for overall participants and not as per dose administered to participants.|||Months||95% Confidence Interval|Median
2663101|NCT01555762|Primary|Progression-Free Survival|Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From the time of first dose of study treatment to the time of disease progression or death from any cause (Up to 53 months)|The efficacy population (EFF) included all participants who had at least one infusion of bevacizumab, without exclusion criteria and excluding participants with no intake of chemotherapy, or intake of bevacizumab before or 2 months after chemotherapy initiation. Data in study was collected for overall participants and not as per dose administered.|||Months||95% Confidence Interval|Median
2663102|NCT01555567|Secondary|Central Activation Ratio|CAR = maximal voluntary isometric contractions force / maximal voluntary isometric contractions force + stimulated force|Time of return to activity (~6 months following surgery)||||ratio||Standard Deviation|Mean
2663103|NCT01555567|Primary|Quadriceps Strength||Time of return to activity (~6 months following surgery)||||Nm/kg||Standard Deviation|Mean
2663104|NCT01555541|Secondary|Unanticipated CTCAE Grade 3 or Higher Adverse Events|NCI CTCAE v 4.0 grade 3 or higher adverse events in the first 24 months NOT anticipated to occur with autologous stem cell transplantation|~ Month 26||2020-01-31|01/2020||||
2663105|NCT01555541|Secondary|Minimal Residual Disease (MRD)|Minimal Residual Disease (MRD), based on the number of positive copies assessed by polymerase chain reaction (PCR)|~ Month 26||2020-01-31|01/2020||||
2663106|NCT01555541|Secondary|Fluorodeoxyglucose-positron Emission Tomography (FDG-PET) Conversion Rate|Number of patients who advance from PR to CR following OVA|~ Month 5|patients with PR after salvage who converted to CR after OVA|||Participants|||Count of Participants
2663107|NCT01555541|Secondary|CR/ Partial Response (PR) Proportion|"CR: See above~PR requires:~Post-treatment PET positive in at least one previously involved site~≥ 50% decrease in sum of product of the diameters (SPD) of up to 6 of largest dominant nodes/nodal masses~No increase in size of other nodes, liver, spleen~Splenic & hepatic nodules must regress ≥ 50% in their sum of the product of the greatest diameters (SPD) or, for single nodules, in the greatest transverse diameter~Involvement of other organs assessable; no measurable disease present (except splenic or hepatic nodules)~Bone marrow assessment irrelevant for PR determination if sample positive before treatment. Patients who achieve CR by above criteria, but with persistent morphologic bone marrow involvement will be considered partial responders. If bone marrow was involved before therapy and clinical CR was achieved, but with no bone marrow assessment after treatment, patients should be considered partial responders~New sites of disease to be observed"|~ Month 5|patients who received OVA and then met criteria to proceed to auto and achieved a CR after auto|||Participants|||Count of Participants
2663108|NCT01555541|Secondary|Overall Survival (OS)|Defined as the time to death for any reason|Up to 5 years after ASCT||2023-01-31|01/2023||||
2663109|NCT01555541|Secondary|Event-Free Survival (EFS)|Measured from day 0 to any treatment failure including disease progression, discontinuation of treatment for any reason, initiation of new therapy without documented progression, incidence of secondary Acute Myeloid Leukemia (AML) or Myelodysplastic syndromes (MDS), or death related to treatment.|Up to 48 months after ASCT||2020-01-31|01/2020||||
2663110|NCT01555541|Secondary|Time to Progression|Defined as time from study entry until documented lymphoma progression or receipt of anti-lymphoma therapy (except for planned post-ASCT radiotherapy) or death due to lymphoma.|Up to 48 months after ASCT||2020-01-31|01/2020||||
2663111|NCT01555541|Secondary|Progression Free Survival|Defined as time from day 0 until lymphoma progression, receipt of anti-lymphoma therapy (except for planned post-ASCT radiotherapy), or death as a result of any cause.|Up to 48 months after ASCT||2020-01-31|01/2020||||
2663112|NCT01555541|Secondary|Time to Platelet Engraftment Following Autologous Stem Cell Transplantation (ASCT)|Platelet engraftment is defined as the first of three consecutive measurements for which the platelet count was > 20,000/uL, and must be at least 24 hours following the last platelet transfusion.|Response evaluation will occur at day +90 after ASCT, and at 6, 12 and 24 months thereafter||2020-01-31|01/2020||||
2663113|NCT01555541|Secondary|Time to Neutrophil Engraftment Following Autologous Stem Cell Transplantation (ASCT)|Neutrophil engraftment is defined as the first day of 3 consecutive days with absolute neutrophil count of >500 cells/microliter (uL).|Response evaluation will occur at day +90 after ASCT, and at 6, 12 and 24 months thereafter||2020-01-31|01/2020||||
2663114|NCT01555541|Primary|Number of Patients Achieving Mobilization-adjusted Complete Response (maCR)|Number of patients achieving complete response to the treatment upon successful stem cell mobilization, defined as at least 2 x10^6 cluster of differentiation 34 (CD34)+cells/Kg of actual body weight. Subjects who require use of plerixafor or an autologous bone marrow harvest are considered mobilization failures and will be treated as non- responders.|Day 42||||Participants|||Count of Participants
2663115|NCT01555541|Primary|Number of Patients Achieving Complete Response (CR) to the Treatment Upon Successful Stem Cell Mobilization|"CR requires:~Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.~Post-treatment residual mass of any size is permitted as long as it is PET negative.~Spleen and/or liver, if enlarged before therapy based on physical examination or CT scan, should not be palpable on physical examination and should be considered normal size by imaging studies, and nodules related to lymphoma should disappear.~If bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. The biopsy sample on which this determination is made must be adequate (with a goal of > 20 mm unilateral core). If the sample is indeterminate by morphology, it should be negative by immunohistochemistry. A sample that is negative by immunohistochemistry but that demonstrates a small population of clonal lymphocytes by flow cytometry will be considered a CR."|Day 42||||Participants|||Count of Participants
2668504|NCT01505673|Secondary|Glucagon|Measured during mixed meal challenge test.|6-months||||pg/mL||Standard Deviation|Mean
2663116|NCT01555489|Secondary|Evaluate Quality of Life Using Functional Assessment of Cancer Therapy-General (FACT-G) Quality Assessment Instrument|1) To evaluate quality of life using Functional Assessment of Cancer Therapy-General (FACT-G) quality assessment instrument. The FACT-G questionnaire as well as the Patient Reported Outcomes Measurement Information System (PROMIS-29) will be used to assess quality-of-life longitudinally. Quality-of-life scores obtained from the FACT-G and PROMIS-29 will be summarized at multiple time points using means and standard deviations.|15 weeks|The trial was closed due to lack of accrual. The standard of care treatment that was part of the study as initially written changed to a different chemotherapy regimen thus not enabling the team to enroll additional patients. The data were not collected.||||||
2663117|NCT01555489|Primary|Safety of Ascorbic Acid in Combination With Gemcitabine and Erlotinib for Stage IV Pancreatic Cancer|Safety: to assess safety of IVAA in combination with gemcitabine and erlotinib by evaluating the number of adverse events and serious adverse events occurring among study participants.|15 weeks|The trial was closed due to lack of accrual. The standard of care treatment that was part of the study as initially written changed to a different chemotherapy regimen thus not enabling the team to enroll additional patients. The data were not collected.||||||
2663118|NCT01555463|Secondary|Change From Baseline in Index Value at End of Treatment|"The EuroQol Group Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L) is a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. It is used to assess the level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension is evaluated using 5 levels: no problems (level 1), slight problems (level 2), moderate problems (level 3), severe problems (level 4), and extreme problems (level 5). A scoring formula developed by EuroQol Group calculates a single index value from the results from all 5 domains along a continuum of 0 (death) to 1 (full health). The median (range) change, defined as the index value at end of treatment minus the index value at baseline, is presented."|Baseline and end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.|||Scores on a scale||Full Range|Median
2663119|NCT01555463|Secondary|Change From Baseline in EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) at End of Treatment|"The EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) is a standardized instrument for use as a measure of health outcome. The EQ-VAS asks for a judgment of the overall health status assessed by the participant her/himself. The 20-cm visual analog scale (VAS) has endpoints labeled best imaginable health state and worst imaginable health state that are anchored at 100 and 0, respectively. Respondents are asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS, which best represents their own health on that day; higher scores indicate a better health state. The median (range) of the change, defined as EQ-VAS at end of treatment minus EQ-VAS at baseline, is presented."|Baseline and end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.|||Scores on a scale||Full Range|Median
2663120|NCT01555463|Secondary|Number of Participants With Change From Baseline in Dermatology Life Quality Index (DLQI) Questionnaire at End of Treatment - Overall Score|"The Dermatology Life Quality Index (DLQI) is a questionnaire consisting of a set of 10 questions that evaluate the degree to which the participant's skin has affected certain behaviors and quality of life over the past week. Possible responses to each question are: very much (question 7: yes) (score=3), a lot (score=2), a little (score=1), or not at all/not relevant (score=0). The DLQI overall score is the sum of the results from all 10 questions, with possible scores ranging from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The number of participants with score changes (end of treatment - baseline) in DLQI overall score from baseline to end of treatment <=-5 and >-5 are presented."|Baseline and end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.|||Participants|||Number
2663121|NCT01555463|Secondary|Change From Baseline in Rosacea Quality of Life (RosaQoL) Questionnaire at End of Treatment - Overall Quality of Life Score|"The Rosacea Quality of Life (RosaQoL) is a questionnaire to evaluate the effect of rosacea on a participant's quality of life. Each of the 21 items in this questionnaire asks about the frequency with which a particular aspect of living with rosacea affects the participant: possible responses for each item are never (score=1), rarely (score=2), sometimes (score=3), often (score=4), or all the time (score=5). The overall score is the sum of the results from all 21 questions, with possible scores ranging from 21 (best) to 105 (worst); the higher the score, the more quality of life is impaired. The mean (standard deviation) of the change, defined as end of treatment overall score minus baseline overall score, is presented."|Baseline and end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.|||Scores on a scale||Standard Deviation|Mean
2663122|NCT01555463|Secondary|Participants' Opinion on Practicability of Product Use in Facial Areas Next to the Hairline at End of Treatment|At the end of treatment, participants provided their opinion on the practicability of the use of the investigational product in facial areas next to the hairline as very good, good, satisfactory, poor, or no opinion. The number of participants in each category of this assessment is presented.|At end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.|||Participants|||Number
2663123|NCT01555463|Secondary|Participants' Opinion on Cosmetic Acceptability at End of Treatment|At the end of treatment, participants provided their opinion on cosmetic acceptability of the investigational product as very good, good, satisfactory, poor, or no opinion. The number of participants in each category of this assessment is presented.|At end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.|||Participants|||Number
2663124|NCT01555463|Secondary|Participants' Global Assessment of Tolerability at End of Treatment|At the end of treatment, participants provided their opinion on local tolerability of the investigational product as excellent, good, acceptable despite minor irritation, less acceptable due to continuous irritation, non-acceptable, or no opinion. The number of participants in each category of this assessment is presented.|At end of treatment, up to 12 weeks|All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.|||Participants|||Number
2663126|NCT01555463|Secondary|Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF)|Facial skin color (as compared with skin outside the treatment area) was rated as: normal; barely visible skin lightening; mild skin lightening; moderate skin lightening; severe skin lightening. The percentage of participants in each category of facial skin color at the end of study is presented.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Percentage of participants|||Number
2663127|NCT01555463|Secondary|Grouped Changes From Baseline in Telangiectasia Intensity Score at End of Treatment (LOCF)|Telangiectasia was rated as: no; mild; moderate; or severe. At the end of study, a participant was considered to have an 'improved' telangiectasia rating if the telangiectasia rating was lower compared to the baseline rating, 'no change' if the rating was identical, and 'worsened' if the rating was higher. The percentage of participants in each category is presented.|Baseline and end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Percentage of participants|||Number
2663128|NCT01555463|Secondary|Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF)|The percentage of participants in each rating category of erythema (clear or almost clear; mild; moderate; severe) at the end of treatment is provided.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Percentage of participants|||Number
2663129|NCT01555463|Secondary|Nominal Value of Inflammatory Lesion Count at End of Treatment (LOCF)|The mean (standard deviation) lesion count at the end of treatment is provided.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Inflammatory lesions||Standard Deviation|Mean
2663130|NCT01555463|Secondary|Percentage of Participants With Investigator's Global Assessment (IGA) Scores at End of Treatment (LOCF)|The IGA consists of 5 scores: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. The percentage of participants with each score at the end of treatment is provided.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Percentage of participants|||Number
2663131|NCT01555463|Secondary|Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF)|Erythema was rated as: clear or almost clear; mild; moderate; or severe. For the assessment of the grouped change in erythema ratings, the baseline examination was used to group into 'improved', 'no change', or 'worsened'. A participant was considered to have an 'improved' erythema rating if the erythema rating was lower compared to the baseline rating, 'no change' if the rating was identical, and 'worsened' if the rating was higher. The percentage of participants in each of these categories is presented.|Baseline and end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Percentage of participants|||Number
2663132|NCT01555463|Secondary|Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Response at End of Treatment (LOCF)|Participants achieving a clear, minimal, or mild IGA at the end of treatment were considered as 'responder'. Participants with an IGA of moderate or severe at the end of treatment were considered as 'non-responder'. Participants who prematurely withdraw from study treatment because of lack of efficacy were coded as 'non-responders'. The percentage of responders is presented.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Percentage of participants|||Number
2663133|NCT01555463|Secondary|Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF)|The mean (standard deviation) percentage change in inflammatory lesion count from baseline to end of study is provided.|Baseline and end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Percent change of inflammatory lesions||Standard Deviation|Mean
2663134|NCT01555463|Primary|Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF)|The mean (standard deviation) change from baseline in the inflammatory lesion count at the end of treatment is provided.|Baseline and end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Inflammatory lesions||Standard Deviation|Mean
2663135|NCT01555463|Primary|Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)|Static evaluation of overall severity of papulopustular rosacea at a given time: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal.|At end of treatment (LOCF), up to 12 weeks|All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.|||Percentage of participants|||Number
2663378|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: Total Cholesterol|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on total cholesterol.|Baseline - Week 12||||mg/dL||Standard Deviation|Mean
2663136|NCT01555164|Secondary|Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24|"The average (mean) change from baseline in 2-hour postprandial serum glucose at Week 24 was analyzed.~Mixed Meal Tolerance Test (MMTT) Full Analysis Set: randomized participants who received at least one dose of study treatment with a baseline and at least one postbaseline measurement of serum glucose at T=120 minutes during the MMTT, administered under fasting conditions, excluding participants with major eligibility protocol violations; analyzed based on the randomized treatment regardless of actual treatment received."|Baseline; Week 24|Participants in the MMTT Full Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
2663137|NCT01555164|Secondary|Change From Baseline in Fasting Serum Glucose at Week 24|The average (mean) change from baseline in fasting serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
2663138|NCT01555164|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|The average (mean) change from baseline in HbA1c at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set (randomized participants who received ≥ 1 dose of study treatment with a baseline and at least one postbaseline measurement of HbA1c, excluding participants with major eligibility violations, and analyzed based on randomized treatment, regardless of actual treatment received) with available data were analyzed.|||percent of HbA1c in blood||Standard Deviation|Mean
2663139|NCT01555151|Secondary|Plasma Cortisol Concentrations|Blood samples were taken from each subject participating in the study post dose at day 1 and week 4. Cortisol concentrations were evaluated. Results are presented as nmol/L|Baseline, days 1 and 28|The safety set includes all subjects who received at least one dose of study drug.|||nmol/L||Standard Deviation|Mean
2663140|NCT01555151|Secondary|Fractional Exhaled Nitric Oxide (FeNO)|FeNO is widely accepted as a non-invasive marker for airway inflammation such as asthma and conducted according to published guideline. FeNO was measured on days 15 and 29 after treatment.|Days 15 and 29|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||ppm||Standard Error|Mean
2663141|NCT01555151|Secondary|Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment|"Mixed model used: percentage of days with no rescue medication use = treatment + age + gender + baseline percentage of days with no rescue use + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.~A day with no rescue use is defined from diary data as any day where the subject does not use any puffs of rescue medication.~The total number of days with no rescue use over the 4 week treatment period is divided by the total number of evaluable days in order to derive the percentage of days with no rescue use."|4 weeks|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||percentage days||Standard Error|Least Squares Mean
2663142|NCT01555151|Secondary|Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment|Rescue medication data recorded during the 14 day run-in period is used to calculate the baseline. - Total number of puffs of rescue medication per day over the full 4 weeks is calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the subject. - MIXED model: Change = treatment + gender + baseline mean daily number of puffs + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.|Baseline and 4 weeks|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||number of puffs||Standard Error|Least Squares Mean
2663143|NCT01555151|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit|Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ-5 has five questions of the asthma symptoms to be answered by the patient. The overall score is the average of the 5 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. - Baseline ACQ-5 is defined as the questionnaire completed on Day 1 (randomization).|Baseline, days 8,15,22 and 29|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||Units on a scale||Standard Error|Least Squares Mean
2663144|NCT01555151|Secondary|Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment|Peak expiratory flow rate (PEFR) was measured via electronice Peak flow meter by patient at home. Mixed model used: change from baseline in the mean evening PEFR = treatment + age + gender + baseline evening PEFR + level of asthma control + region + center (region)+ error. Center is included as a random effect nested within region.|Baseline and week 4|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||Liters per min||Standard Error|Least Squares Mean
2663145|NCT01555151|Secondary|Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points|Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. Data within 6 hr of rescue medication use is excluded from this analysis.|Days 1, 8, 15, 22, 28 and 29 at all time points|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||Percent||Standard Error|Least Squares Mean
2663146|NCT01555151|Secondary|Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points|The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.|Days 1, 8, 15, 22, 28 and 29 at all time points|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||Liters per second||Standard Error|Least Squares Mean
2663199|NCT01554982|Primary|Safety Parameters|Safety was assessed by recording and monitoring adverse events (AEs), serious adverse events (SAEs), and sequential laboratory data. Rates of AEs were summarized by system organ class, preferred term, severity, and suspected relationship to KRX-0502 (ferric citrate).|48 Weeks|Safety Population; Treatment Emergent Adverse Events (TEAEs), not including SAEs, reported include only those occurring at a frequency >5%|||participants|||Number
2663147|NCT01555151|Secondary|Forced Vital Capacity (FVC) at All Time Points|Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data within 6 hr of rescue medication use is excluded from this analysis. Mixed model: FVC = treatment + gender+ baseline FVC + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.|Days 1, 8, 15, 22, 28 and 29 at all time points|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||Liters||Standard Error|Least Squares Mean
2663148|NCT01555151|Secondary|Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment|Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on days 8, 15 and 22 after treatment. Data within 6 hr of rescue medication use is excluded from this analysis.|Days 8, 15 and 22|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||Liters||Standard Error|Least Squares Mean
2663149|NCT01555151|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1)|Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment.|Day 29|The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study drug with available data for analysis.|||Liters||Standard Error|Least Squares Mean
2663150|NCT01555138|Secondary|St Georges Respiratory Questionnaire for COPD|A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.|12 and 26 weeks|Full Analysis set|||scores on a scale||Standard Error|Least Squares Mean
2663151|NCT01555138|Secondary|Rescue Medication Use Over 26 Weeks: Percentage of 'Days With no Rescue Use'|A 'day with no rescue use' is defined from diary data as any day where the patient has taken no puffs of rescue medication. The percentage of 'days with no rescue use' will be derived and analyzed as for the percentage of 'nights with no nighttime awakenings'.|26 weeks|Full Analysis Set|||% of Days||Standard Error|Least Squares Mean
2663152|NCT01555138|Secondary|Mean Daily Number of Puffs of Rescue Medication Used Over 26 Weeks of Treatment|The mean daily number of puffs of rescue medication taken by the patient will be derived. If the number of puffs is missing for part of the day (either morning or evening) then a half day will be used in the denominator. Rescue medication data recorded during the 14 day run-in period will be used to calculate the baseline. The mean change from baseline in the daily number of puffs of rescue medication will be analyzed using the same mixed model as specified for the primary analysis, with the baseline FEV1 replaced with the baseline daily rescue use.|12 and 26 weeks||||number of puffs||Standard Deviation|Mean
2663153|NCT01555138|Secondary|Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set)|The number of exacerbations during the 26 week treatment period will be analyzed using a generalized linear model assuming a negative binomial distribution.|26 weeks||||participants|||Number
2663154|NCT01555138|Secondary|TDI Focal Score at Week 12 and Week 26: Treatment Comparisons|The Transition Dyspnea Index (TDI) total score after 12 and 26 weeks of treatment will be analyzed using the same mixed model as specified for the primary analysis with the Baseline Dyspnea Index (BDI) total score as the baseline.Total score ranging - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea. One additional option in each category, which does not contribute to the score, allows for circumstances in which impairment is due to reasons other than dyspnea.|12 and 26 weeks||||Units on a scale||Standard Error|Least Squares Mean
2663155|NCT01555138|Secondary|Analysis of AUC (5 Min - 4 h) for FEV1 (L) at Week 12 and Week 26: Treatment Comparison|The standardized (with respect to the length of time) AUC for FEV1 will be calculated between 5 min and 4 h post morning dose as the sum of trapezoids divided by the length of time at Day 84 (Visit 6) and Day 182 (Visit 10). Scheduled (not actual) time points are to be used. FEV1 measurements taken within 6 h of rescue use will be set to missing before the standardized AUC is calculated.|12 and 26 weeks|Full analysis set|||Liters||Standard Error|Least Squares Mean
2663156|NCT01555138|Secondary|FVC Over 26 Weeks of Treatment|FVC at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group.|12 and 26 weeks|Full analysis set|||Liters||Standard Error|Least Squares Mean
2663157|NCT01555138|Secondary|FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons|FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group .|26 weeks|Full analysis set|||Liters||Standard Error|Least Squares Mean
2663158|NCT01555138|Secondary|FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons|FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group.|12 weeks|Full analysis set|||Liters||Standard Error|Least Squares Mean
2663159|NCT01555138|Secondary|Trough FEV1 (L) at Week 26 (Imputed With LOCF): Treatment Comparisons|Trough FEV1 is defined as the average of the 23 h 10 min and the 23 h 45 min values taken in the clinic at Visit 11.|26 weeks|Full analysis set|||Liters||Standard Error|Least Squares Mean
2663200|NCT01554904|Secondary|Apnea-Hypopnea Index (AHI)|The number of apneas and hypopneas per hour of monitoring|baseline and after 6 weeks of facial muscle training|Participants completing 6 weeks of training and second sleep study|||events per hour||Standard Deviation|Mean
2663485|NCT01552213|Secondary|Number of Participants With Neonatal Hypoglycemia|Infants treated for neonatal hypoglycemia-- Glucose of <36 mg/dl; <2 millimoles (mM)|1 week after delivery|Participants with available data included in the analysis.|||Participants|||Count of Participants
2663160|NCT01555138|Primary|Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons|Spirometry conducted to internationally accepted standards. Trough FEV1 defined as the mean of the FEV1 measurements at 23 h 10 min and 23 h 45 min post the Day 84 morning dose. The primary variable (imputed with last observation carried forward) will be analysed using a mixed model for the Per Protocol Set (PPS). The model will contain treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 10-15 min post inhalation of salbutamol (components of reversibility at Visit 1) as covariates.|12 weeks|full analysis set|||Liters||Standard Error|Least Squares Mean
2663161|NCT01555125|Secondary|Number of Participants Developing Treatment Emergent Anti-secukinumab Antibodies, Immunogenicity|The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to 8 weeks after last treatment|Baseline and at Week 12, 24, 52, 100, 148, and 196, 204||||Number of participants|||Number
2663162|NCT01555125|Secondary|Number of Participants in Each IGA Mod 2011 Category After Week 52 (Observed Data)|The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe. The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe|Week 172|Full analysis set (FAS) - All patients to whom study treatment was assigned. Results after Week 172 and beyond cannot be interpreted meaningfully due to low number of evaluable patients at these visits.|||Number of participants|||Number
2663163|NCT01555125|Secondary|Absolute Change From Baseline for PASI Score After Week 52, (Observed Data)|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)|Week 172|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
2663164|NCT01555125|Secondary|Number of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 After Week 52|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline.|Week 172|Full analysis set (FAS) - All patients to whom study treatment was assigned. Results after Week 172 and beyond cannot be interpreted meaningfully due to low number of evaluable patients at these visits.|||Number of participants|||Number
2663165|NCT01555125|Secondary|Percentage of Participants Achieving a DLQI Score of 0 or 1 Over Time up to Week 52, (Maintenance)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percentage of participants|||Number
2663166|NCT01555125|Secondary|Percentage of Participants Achieving a DLQI Score of 0 or 1 at Week 12, (Induction)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Week 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percentage of participants|||Number
2663167|NCT01555125|Secondary|Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Score Over Time up to Week 52, (Maintenance)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. This result was reflected in the percentage change from baseline at Week 12, higher reductions (improvements) in DLQI scores (median treatment difference)."|Baseline and week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percent change||95% Confidence Interval|Median
2663168|NCT01555125|Secondary|Median Percentage Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score, (Induction)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. This result was reflected in the percentage change from baseline at Week 12, higher reductions (improvements) in DLQI scores (median treatment difference)."|Baseline and week 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percent change||95% Confidence Interval|Median
2663263|NCT01553851|Primary|Number of Participants With Changes in TumorCell Surface CD44 Expression After Treatment With GSK1120212.|Pre-post measure of CD44 expression using IHC.|Baseline and Day 15||||Participants|||Number
2668505|NCT01505673|Secondary|Beta-Cell Function|Fasting Glucose as a Measure of Beta-Cell Function|6-months||||mg/dL||Standard Deviation|Mean
2663169|NCT01555125|Secondary|Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Over Time up to Week 52, (Maintenance)|"ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example confined to bed) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)"|Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
2663170|NCT01555125|Secondary|Change From Baseline in EQ-5D at Week 12 (Induction)|"ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example confined to bed) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)"|Week 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
2663171|NCT01555125|Secondary|Percentage of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category Over Time up to Week 52, (Maintenance; Observed Data)|The IGA mod 2011 category scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percentage of participants|||Number
2663172|NCT01555125|Secondary|Number of Participants in Each Investigator's Global Assessment (IGA) Mod 2011 Category at Week 12, (Induction)|The IGA mod 2011 category scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe|Week 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Number of participants|||Number
2663173|NCT01555125|Secondary|Absolute Change From Baseline for PASI Score Over Time up to Week 52, (Maintenance; Observed Data)|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)|Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
2663174|NCT01555125|Secondary|Absolute Change From Baseline for PASI Score at Week 12, (Induction)|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)|Week 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
2663175|NCT01555125|Secondary|Percent of Responders With Investigator's Global Assessment (IGA) Mod 2011 Score of 0 or 1, (Maintenance; Observed Data)|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percentage of participants|||Number
2663176|NCT01555125|Secondary|Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Maintenance; Observed Data)|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline.|Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percentage of participants|||Number
2663177|NCT01555125|Secondary|Percent of Responders With Psoriasis Area and Severity Index (PASI) Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100, (Induction) With Non-responder Imputation|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline.|Week 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percentage of participants|||Number
2663178|NCT01555125|Secondary|Percentage of Subjects With Successful Self Administration of Study Drug at Week 1|To assess the subject's ability to follow instructions for use with the secukinumab PFS|Week 1|Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received|||Percentage of participants|||Number
2663179|NCT01555125|Secondary|Number of Subjects With Potential Use Related Hazards at Week 1|To assess potential use-related hazards with the secukinumab PFS for the subject|Week 1|Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received|||Number of participants|||Number
2663180|NCT01555125|Secondary|Absolute Change From Baseline in Self-Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 48|The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Baseline, week 48|Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received.|||Score||Standard Deviation|Mean
2663181|NCT01555125|Secondary|Absolute Change From Baseline in Self Injection Assessment Questionnaire (SIAQ) Domain Scores at Week 12|The three domains of the POST SIAQ are feelings about injections, self-image, self-confidence, injection-site reactions, ease of use, and satisfaction with self-injection. The SIAQ items are scored on a semantic Likert-type scale where lower numbers indicate a worse experience. Domain scores range from 0 to 10. Subjects self-injecting at this visit completed this SIAQ questionnaire. The POST-SIAQ is taken after the injection at that visit.|Week 12|Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were analyzed according to treatment received|||Score||Standard Deviation|Mean
2663182|NCT01555125|Primary|Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) With a 0 or 1 Response at Week 12|The IGA scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit. IGA has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe|12 weeks|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percentage of Participants|||Number
2663183|NCT01555125|Primary|Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis at Week 12 Measure: PASI 75 (Psoriasis Area and Severity Index) Response.|A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis|12 weeks|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percentage of participants|||Number
2663184|NCT01555073|Secondary|Quality of Life|To register the quality of life of patients receiving the four study arms following uterine artery embolisation during immediate and long term time periods.|Expected average of 12 weeks|Early termination due to lost of follow-up for primary outcome at 3 months||||||
2663185|NCT01555073|Primary|Post Operative Pain Control|To evaluate the post operative pain control of the four groups in immediate postoperative period and months following uterine artery embolisation procedure.|Expected average of 12 weeks|Early termination due to lost of follow-up for primary outcome at 3 months||||||
2663186|NCT01555021|Secondary|Adverse Events (Side Effects)|"To determine the impact of AGT versus TAU on total number of side effects determined by using the Udvalg for Kliniske Undersogelser (UKU).~TAU group reported a total of 8 different side effects, but 11 total events with two subjects over the time frame listed below; the events were expected. (see itemized adverse events)~AGT group reported a total of four different side effects and 4 events with one subject over the time frame listed; the events were expected.(see itemized adverse events)"|Measures at discharge, 1 month, 3 months, and 6 months|Missing data on one AGT subjects|||Number of side effects|||Number
2663187|NCT01555021|Secondary|Treatment Adherence|To determine the impact on adherence of AGT versus TAU at 7-10 days after admission|To determine the impact on adherence of AGT versus TAU at 7-10 days after admission|Number of subjects adherent to antidepressant medications|||Participants|||Count of Participants
2663188|NCT01555021|Secondary|Clinician's Report That AGT Modified His/Her Decision Regarding Which Antidepressant to Prescribe.|Clinicians randomized to receive AGT results were asked to report whether the AGT results impacted their decision making with regards to their choice of antidepressant and/or dosing of the antidepressant.|Measured: +/- 24 hours of baseline assessments and +/- 24 hours of receiving assay results|2 of 4 clinicians received AGT results for antidepressant decision making. One of two clinicians randomized to receive AGT results reported that his choice of antidepressant was definitely influenced by AGT results; the other clinician randomized to receive AGT results did not receive the AGT information within the defined time limit.|||participants|||Number
2663189|NCT01555021|Primary|Change in Quick Inventory of Depressive Symptoms-Self Rating (SR) 16 Item|To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU), in terms of depression severity as measured by change in the Quick Inventory of Depressive Symptoms (QIDS-SR 16), adjusted for baseline severity, upon discharge, and at 1, 3, and 6 months post discharge from inpatient treatment. The QUIDS-SR 16 is a self rating 16 item multiple-choice questionnaire that measure severity of depression over the past week. The range on the QIDS-SR IS 0-27, with 0-5 indicating no depression; 6-10, mild depression; 11-15; moderate depression; 16-20 severe depression; and greater than or equal to 21, very severe depression.|Measured: Baseline (within 72 hours of admission), once weekly (+/- 24 hours), discharge (7-10 days after admission +/- 24 hours), and 1, 3, 6 months after discharge (+/- 4 weeks)|Quick Inventory of Depression symptom-16 (QIDS-SR 16) Baseline. Data was not collected for all time points for all participants.|||Score on QIDS-SR||Full Range|Mean
2663190|NCT01554982|Other Pre-specified|IV Iron Use|Percent of subjects with No IV iron intake from first dose of study drug to Week 48|48 weeks||||percentage of participants|||Number
2663191|NCT01554982|Other Pre-specified|Hemoglobin- Week 48||48 weeks||||g/dL||Standard Deviation|Mean
2663192|NCT01554982|Other Pre-specified|Hemoglobin- Baseline||Baseline||||g/dL||Standard Deviation|Mean
2663193|NCT01554982|Other Pre-specified|TSAT- Week 48||48 weeks||||percentage of saturation||Standard Deviation|Mean
2663194|NCT01554982|Other Pre-specified|Transferrin Saturation (TSAT) - Baseline||Baseline||||percentage of saturation||Standard Deviation|Mean
2663195|NCT01554982|Other Pre-specified|Ferritin- Week 48||48 weeks||||ng/mL||Standard Deviation|Mean
2663201|NCT01554904|Primary|Snore Index|The snore index is the number of snores per hour of monitoring. The pre-treatment and post-treatment (6 weeks) values will be compared. A snore is a vibratory noise usually noted during inspiration and associated with vibration of the uvula and palate. The snore sensor in this study is the nasal pressure cannula connected to a sensitive pressure transducer. Snoring is detected as a fine (high frequency) oscillation superimposed on the nasal pressure waveform. The device [Sleep Scout (ClevMed, Cleveland Ohio)] has an automated scoring detection algorithm to identify breaths with snoring. Each breath with vibration is counted as a snore. As the algorithm is automated and the same snore threshold was used for both baseline and 6 week sleep studies, this prevents technologist bias in detecting snores (breaths with vibration).|baseline and after 6 weeks of facial muscle training|Subjects completing 6 weeks of training and Home Sleep Test # 2|||snores per hour of monitoring||Standard Deviation|Mean
2663202|NCT01554891|Primary|Sensitivity and Specificity of the SAFE-TBI|Sensitivity = True Positives/(True Positive + False Negatives) Specificity = True Negatives/(True Negative + False Positives) Cutoff 2 = At least moderate evidence of TBI vs. no or weak evidence of TBI|6-months after medical evacuation|Data were only collected for cohort 3.|||percentage|||Number
2663203|NCT01554891|Primary|Concordance Rate of Current VA Screening Instruments and the SAFE-TBI.|Concordance rate of current VA TBI screening instruments and the SAFE-TBI in 100 OEF/OIF/OND veterans who have screened positive for TBI (Cohort 2) Cohort 2: The primary endpoint for this sub-study is the distribution of SAFE-TBI outcome (percent assigned to each evidence category of the SAFE-TBI) in a group of veterans who have screened positive on the VA TBI screen. (Speciﬁc Aim 2).|baseline|Analyses done for Cohort 2 only.|||percentage of participants||95% Confidence Interval|Number
2663204|NCT01554891|Primary|Test-retest Reliability SAFE-TBI|Reliability of SAFE-TBI, as determined by test-retest and inter-rater reliability, in a sample of 100 veterans recently returned from deployment (Cohort 1) Cohort 1: The primary endpoints for this sub-study (cohort) are the degree of agreement for SAFE-TBI outcome (no evidence of TBI vs. at least, weak evidence of TBI) across the two assessment time points (initial vs. 4 to 6 weeks) as well as the two rater types TRC vs. TBIC. (Speciﬁc Aim 1).|Up to 6 weeks|Analyses done on Cohort 1, and a subset of Cohort 2 and 3 who got repeat interview.|||kappa (reliability)||95% Confidence Interval|Number
2663205|NCT01554579|Secondary|SF-36|The SF-36 (acute version 2) was a 36 question survey administered at Baseline and at the end of study or early termination (Week 4). The questionnaire contained numerous domain scores to evaluate physical function, mental function, general health, bodily pain, social functioning and vitality. The question of interest for the analysis was question #1 regarding walking pain. Scores range from 0 - 100. A lower score means decreased pain while walking and a higher score means increased pain while walking.|4 Weeks|Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores.|||units on a scale||Standard Deviation|Mean
2663206|NCT01554579|Secondary|WOMAC Scores|This is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). This is a questionnaire that asks subjects to evaluate their pain, stiffness, and physical activities affecting their knee over the past 48 hours. Subjects evaluate their pain, stiffness and physical activities by selecting a number between 0 and 10 where 0 is no pain/no stiffness/no difficulty doing physical activities and 10 is extreme pain/extreme stiffness/extreme difficulty doing physical activities. The questionnaire was administered at Screening, Baseline and at the end of Week 4 by telephone (an interactive voice response system [IVRS]) before bedtime. The scores for each category are totaled (range is 0-100). A lower total score means less pain and a higher total score means greater pain.|4 Weeks|Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores.|||units on a scale||Standard Deviation|Mean
2663207|NCT01554579|Primary|The Primary Efficacy Endpoint of This Study is the Weekly Average Daily NPRS (Average Pain)|Subjects were instructed to select a number on a scale that best described their knee arthritis pain during the past 24 hours. The scale was between 0 and 10 where 0 was no pain and 10 was the worst possible pain. The scale was completed by telephone (an interactive voice response system [IVRS]) every evening before bedtime.|2 Weeks|Per protocol population defined as subjects who received at least 1 dose of drug, had at least 1 post-baseline efficacy measure, complied with protocol and did not have major protocol deviations. Compliance with the protocol defined as having (in the last week of the study) a weekly average NPRS score w/ at least 50% non-missing dairy NPRS scores.|||units on a scale||Full Range|Mean
2663208|NCT01554527|Other Pre-specified|Change in Cognition After AT as Shown by Academic Achievement|Academic achievement mean score is a standardized score with a mean of 100 and SD 15. Minimum value 40 and Maximum value 160. Higher scores are better|assessed as change from baseline to 6 months of CPAP therapy or no-CPAP|Data from two participants are not available|||units on a scale||Standard Deviation|Mean
2663209|NCT01554527|Other Pre-specified|Change in Cognition as Measured by Fluid Cognition Scores|Scores are reported as standardized scores with a mean of 100 and SD of 15. Minimum value 40, Maximum value 160. Higher scores are better|assessed as change from baseline to 6 months of CPAP therapy or no-CPAP|Lower numbers are shown here as the tool is not appropriate for younger children|||score on a scale||Standard Deviation|Mean
2663210|NCT01554527|Secondary|CPAP Adherence as Measured by Number of Participants Who Used the CPAP Consistently.|CPAP adherence data will be downloaded from CPAP machines. It is defined for this study as using the CPAP machine for at least an average of 4 hours per night during the last 60 days of the assignment.|Starting at 4 months after AT and continuing through 10 months after AT||||Participants|||Count of Participants
2663211|NCT01554527|Secondary|Change in Quality of Life as Measured by Peds QL|Peds-QL is a quality of life symptom measurement with a score range of 0 to 100. Higher scores are better quality of life|assessed as change from baseline to 6 months of CPAP therapy or no-CPAP|Data for one participant is not available|||score on a scale||Standard Deviation|Mean
2663392|NCT01552928|Secondary|Maximum Plasma Concentration (Cmax) of 0.5 mg Anagrelide in Males and Females||Over 12 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.|||ng/ml||Standard Deviation|Geometric Mean
2663212|NCT01554527|Secondary|Change in Sleepiness After AT as Measured by Multiple Sleep Latency Test (MSLT)|Multiple Sleep Latency Test (MSLT) is an objective measure of sleepiness determined by measure of brain waves and other physiological signals over a 30 minute period. This is measured for five 30 minute periods across the day and average latency to sleep for each participant across those times were used to calculate the mean sleep latency. The score is measured in how quickly one would fall asleep, measured in minutes, so a negative number of minutes in the change score means that participants fell asleep more quickly than previously.|assessed as change from baseline to 6 months of CPAP therapy or no-CPAP|Data for one participant are not available|||minutes||Standard Deviation|Mean
2663213|NCT01554527|Secondary|Change in Sleepiness as Measured by Epworth Sleepiness Scale|Epworth Sleepiness Scale scores range from 0 to 24 where higher scores mean greater sleepiness.|assessed as change from baseline to 6 months of CPAP therapy or no-CPAP|Data for two participants are not available|||score on a scale||Standard Deviation|Mean
2663214|NCT01554527|Secondary|Change in Cognition as Shown by NIH Toolbox Composite Score|Scores are reported as standardized scores with a mean of 100 and SD of 15. Minimum value 40 and Maximum value 160. Higher scores are better|assessed as change from baseline to 6 months of CPAP therapy or no-CPAP|Lower numbers of participants analyzed are shown here because the tool is not appropriate for younger children|||score on a scale||Standard Deviation|Mean
2663215|NCT01554527|Primary|Change in Behavioral Index After 6 Months of CPAP or No-CPAP|"The sum of the T-scores of The Conners' Parent Rating Scales (CPRS-R:L, ADHD index) and the Child Behavior Checklist (CBCL, Attention Deficit/Hyperactivity Problems) are used to construct the primary study outcome measure Behavioral Index. Behavioral index is a T score (adjusted for age and gender) with a range of <10 to >90 - where higher scores mean worse behavior and lower scores mean better behavior, so a negative change score represents an improvement in behavior. T-scores with a mean of 50 and SD of 10 are computed."|assessed as change from baseline to 6 months of CPAP therapy or no-CPAP|Data for two participants in the control group are not available.|||T score||Standard Deviation|Mean
2663216|NCT01554488|Other Pre-specified|Percentage Fat Content (Fat Fraction) of Pharyngeal Upper Airway Surrounding Structures at Week 16|Pharyngeal upper airway fat content was assessed on Magnetic Resonance (MR) imaging, as we published (1). We scanned the area extending from the level of the roof of the hard palate to the vocal cords, with the subject awake and lying on their back, We used a specialized technique called Iterative Decomposition of water and fat with Echo Asymmetry and Least squares estimation Fast Spin-Echo (IDEAL-FSE). In brief, at first, the method provides well co-registered, separate water and fat images, which are free from the artifact that corrupts the usual MR images. Subsequently, these separate images are recombined in new high resolution images which provide: 1) comprehensive anatomical reference to delineate the tongue and measure its volume, and; 2) unambiguous separation of adipose tissue, to allow determination of fat volume and fraction in the upper airway structures.|16-week randomized controlled phase|1 subject in High dose and 2 subjects in Low dose inhaled fluticasone groups had contraindications, eg, metal in their bodies (2) or claustrophobia (1) and could not undergo MRI testing, per the set exclusion criteria.|||percentage of total airway volume||Standard Deviation|Mean
2663217|NCT01554488|Other Pre-specified|Volume of Pharyngeal Upper Airway Surrounding Structures at Week 16|The volume of pharyngeal upper airway surrounding structures was assessed on Magnetic Resonance (MR) imaging, as we published (1). We scanned the area extending from the level of the roof of the hard palate to the vocal cords, with the subject awake and lying on their back, We used a specialized technique called Iterative Decomposition of water and fat with Echo Asymmetry and Least squares estimation Fast Spin-Echo (IDEAL-FSE). In brief, at first, the method provides well co-registered, separate water and fat images, which are free from the artifact that corrupts the usual MR images. Subsequently, these separate images are recombined in new high resolution images which provide: 1) comprehensive anatomical reference to delineate the tongue and measure its volume, and; 2) unambiguous separation of adipose tissue, to allow determination of fat volume and fraction in the upper airway structures.|16-week randomized controlled phase|1 subject in High dose and 2 subjects in Low dose inhaled fluticasone groups had contraindications, eg, metal in their bodies (2) or claustrophobia (1) and could not undergo MRI testing, per the set exclusion criteria.|||mm^3||Standard Deviation|Mean
2663218|NCT01554488|Other Pre-specified|Percentage Fat Content (Fat Fraction) of the Tongue at Week 16|Tongue fat content was assessed on Magnetic Resonance (MR) imaging of the area extending from the level of the roof of the hard palate to the vocal cords, with the subject awake and lying on their back. We used a specialized technique called Iterative Decomposition of water and fat with Echo Asymmetry and Least squares estimation Fast Spin-Echo (IDEAL-FSE), developed at University of Wisconsin by our collaborator and used for assessing the tongue (2). In brief, at first, the method provides well co-registered, separate water and fat images, which are free from the artifact that corrupts the usual MR images. Subsequently, these separate images are recombined in new high resolution images which provide: 1) comprehensive anatomical reference to delineate the tongue and measure its volume, and; 2) unambiguous separation of adipose tissue, to allow determination of fat volume and fraction in the tongue.|16-week randomized controlled phase|1 subject in High dose and 2 subjects in Low dose inhaled fluticasone groups had contraindications, eg, metal in their bodies (2) or claustrophobia (1) and could not undergo MRI testing, per the set exclusion criteria.|||percentage of total tongue volume||Standard Deviation|Mean
2663219|NCT01554488|Other Pre-specified|Tongue Volume at Week 16|Tongue volume was assessed on Magnetic Resonance (MR) imaging of the area extending from the level of the roof of the hard palate to the vocal cords, with the subject awake and lying on their back. We used a specialized technique called Iterative Decomposition of water and fat with Echo Asymmetry and Least squares estimation Fast Spin-Echo (IDEAL-FSE), developed at University of Wisconsin by our collaborator and used for assessing the tongue (2). In brief, at first, the method provides well co-registered, separate water and fat images, which are free from the artifact that corrupts the usual MR images. Subsequently, these separate images are recombined in new high resolution images which provide: 1) comprehensive anatomical reference to delineate the tongue and measure its volume, and; 2) unambiguous separation of adipose tissue, to allow determination of fat volume and fraction in the tongue.|16-week randomized treatment phase|1 subject in High dose and 2 subjects in Low dose inhaled fluticasone groups had contraindications, eg, metal in their bodies (2) or claustrophobia (1) and could not undergo MRI testing, per the set exclusion criteria.|||mm^3||Standard Deviation|Mean
2668506|NCT01505673|Secondary|Weight||6-months||||Kilograms||Standard Deviation|Mean
2663220|NCT01554488|Secondary|Tongue Fatigability of Posterior Location at Week 16|Wakefulness tongue function was measured using the Iowa Oral Performance Instrument (IOPI) at anterior and posterior tongue locations, as described in the referenced citation. In brief, this instrument has a small-sized, air-filled plastic balloon, called sensor or bulb, which was inserted between the tongue blade and the roof of the mouth. At each location, the tongue strength was determined as the maximum pressure generated against the IOPI bulb during a forced tongue contraction. Then, tongue fatigability was measured through a submaximal task, as the time (in seconds) able to maintain > 50% of the above measured strength, at each location. Several standardized trials were conducted for each measure and at each location, to ensure reproducibility.|16-week randomized treatment phase||||seconds||Standard Deviation|Mean
2663221|NCT01554488|Secondary|Tongue Fatigability at Anterior Location at Week 16|Wakefulness tongue function was measured using the Iowa Oral Performance Instrument (IOPI) at anterior and posterior tongue locations, as described in the referenced citation. In brief, this instrument has a small-sized, air-filled plastic balloon, called sensor or bulb, which was inserted between the tongue blade and the roof of the mouth. At each location, the tongue strength was determined as the maximum pressure generated against the IOPI bulb during a forced tongue contraction. Then, tongue fatigability was measured through a submaximal task, as the time (in seconds) able to maintain > 50% of the above measured strength, at each location. Several standardized trials were conducted for each measure and at each location, to ensure reproducibility.|16-week randomized treatment phase||||seconds||Standard Deviation|Mean
2663222|NCT01554488|Secondary|Tongue Strength at Posterior Location at Week 16|Wakefulness tongue function was measured using the Iowa Oral Performance Instrument (IOPI) at anterior and posterior tongue locations, as described in the referenced citation. In brief, this instrument has a small-sized, air-filled plastic balloon, called sensor or bulb, which was inserted between the tongue blade and the roof of the mouth. At each location, the tongue strength was determined as the maximum pressure generated against the IOPI bulb during a forced tongue contraction. Several standardized trials were conducted to ensure reproducibility.|16-week randomized phase||||KiloPascals||Standard Deviation|Mean
2663223|NCT01554488|Secondary|Tongue Strength at Anterior Location at Week 16|Wakefulness tongue function was measured using the Iowa Oral Performance Instrument (IOPI) at anterior and posterior tongue locations, as described in the referenced citation. In brief, this instrument has a small-sized, air-filled plastic balloon, called sensor or bulb, which was inserted between the tongue blade and the roof of the mouth. At each location, the tongue strength was determined as the maximum pressure generated against the IOPI bulb during a forced tongue contraction. Several standardized trials were conducted to ensure reproducibility.|16-week randomized phase||||KiloPascals||Standard Deviation|Mean
2663224|NCT01554488|Primary|Upper Airway Critical Closing Pressure (Pcrit) at Week 16|Pressure at which the pharyngeal upper airway closes during stable non-REM sleep, measured as described in the referenced citation.|16-week randomized controlled phase||||cmH2O||Standard Deviation|Mean
2663225|NCT01554241|Secondary|Free 25-OH Vitamin D3|circulating free 25-OH vitamin D3 concentration|16 weeks||||pg/mL||Standard Deviation|Mean
2663226|NCT01554241|Primary|Total 25-OH Vitamin D3 Level|circulating total 25-OH vitamin D concentration|16 weeks||||ng/mL||Standard Deviation|Mean
2663227|NCT01554176|Primary|Number of Participants Who Discontinued Study Drug Due to an AE During Run-out Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) or a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants who discontinued study drug treatment due to an AE during the 2-week run-out phase are counted once in this summary.|From first run-out dose (following Week 6 visit) up to Week 8 (2 weeks)|All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.|||Participants|||Number
2663228|NCT01554176|Primary|Number of Participants With an AE During Run-out Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants with one or more AEs during the 2-week run-out phase and/or during the 2-week follow up after the last dose of study drug, are counted once in this summary.|From first run-out dose (following Week 6 visit) up to 14 days after last dose of study drug (approximately 4 weeks)|All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.|||Participants|||Number
2663229|NCT01554176|Primary|Number of Participants Who Discontinued Study Drug Due to an AE During Treatment Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants who discontinued study drug treatment due to an AE during the treatment phase (up to study Week 6) are counted once in this summary.|Up to Week 6|All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.|||Participants|||Number
2663230|NCT01554176|Primary|Number of Participants With an Adverse Event (AE) During Treatment Phase|An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration, whether or not considered related to the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with study drug administration, is also an AE. Participants with one or more AEs during the treatment phase (up to study Week 6) are counted once in this summary.|Up to Week 6|All Participants as Treated (APaT): Population includes participants who took ≥1 dose of study drug.|||Participants|||Number
2663264|NCT01553851|Primary|Number of Participants With Changes in Putative Tumor Initiating Cell Populations as Defined by Cell Surface CD44 and Intracellular Phospho-ERK1/2 Staining After Treatment With GSK1120212.|Pre-post measure of p-EKP expression was measured by change in staining intensity and quartile distribution.|Baseline and Day 15|Only15 of the 17 participants had sufficient pre- and post-treatment biopsies with sufficient tumor content to be evaluated for this biomarker assessment.|||participants|||Number
2663231|NCT01554176|Secondary|Percentage of Participants With HAM-D17 Remission (HAM-D17 Total Score ≤7) at Week 6|The HAM-D, an instrument for evaluating severity of symptoms of depression, was completed by the participant. The instrument used in this study was the 17-item version (HAM-D17). Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4), with higher scores indicating greater symptom severity. Total score ranged from 0 to 54. The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), suicidal thoughts, work and interests, psychomotor retardation, psychomotor agitation, anxiety (psychic), anxiety (somatic), and hypochondriasis (somatization). The following symptoms were rated on a 3-point scale (0-2): insomnia (initial), insomnia (middle), insomnia (late), gastrointestinal symptoms (appetite), somatic symptoms (general), sexual disturbances, insight, and weight loss. A participant with HAM-D17 total score ≤7 at Week 6 of the Treatment Phase was defined to have achieved HAM-D17 remission.|Week 6|Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 HAM-D17 score.|||percentage of participants|||Number
2663232|NCT01554176|Secondary|Change From Baseline to Week 6 in the Hamilton Depression Rating Scale, 17-item Version (HAM-D17) Bech Subscale Score|The HAM-D, an instrument for evaluating severity of symptoms of depression, was completed by the participant. The instrument used in this study was the 17-item version (HAM-D17). The Bech subscale of the HAM-D17 is composed of 6 identified items out of the 17 items rated. Each item is rated on either a 3-point scale (0 to 2) or a 5-point scale (0 to 4). Total score ranged from 0 to 22, with a higher score indicating greater symptom severity. The following symptoms were rated on a 5-point scale (0-4): depressed mood, low self-esteem (guilt), work and interests, psychomotor retardation, and anxiety (psychic). The following symptom was rated on a 3-point scale (0-2): somatic symptoms (general). The reported measure is the change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.|Baseline and Week 6|Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 HAM-D17 Beck Subscale score.|||score on a scale||Standard Deviation|Mean
2663233|NCT01554176|Secondary|Change From Baseline to Week 6 in MADRS Total Score Excluding the Sleep Item|"The MADRS is a 10-item clinician-rated instrument for evaluating severity of symptoms of depression. Each item is rated on a scale from 0 to 6, with higher scores indicating greater symptom severity. The total score ranged from 0 to 54, with higher scores corresponding to greater symptom severity. This measure considered 9 of the 10 MADRS items: apparent sadness, reported sadness, inner tension, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. It excluded reduced sleep. The reported measure is the mean change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values."|Baseline and Week 6|Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 MADRS score.|||score on a scale||Standard Deviation|Mean
2663234|NCT01554176|Primary|Change From Baseline to Week 6 in Montgomery Asberg Depression Rating Scale (MADRS) Total Score|The MADRS is a 10-item clinician-rated instrument for evaluating severity of symptoms of depression. Each item is rated on a scale from 0 to 6, with total scores ranging from 0 to 60; higher scores correspond to greater symptom severity. The reported measure is the mean change from baseline to Week 6 of the Treatment Phase; improvement in symptoms is represented by negative values.|Baseline and Week 6|Full Analysis Set (FAS) - population included participants who took ≥1 dose of study drug and had a baseline and Week 6 value.|||score on a scale||Standard Deviation|Mean
2663235|NCT01554163|Secondary|Time-Weighted Mean Response on the Investigator Global Assessment of Response to Therapy|Study investigators were asked to rate the global assessment of participant response to therapy on a Likert scale from 0 to 4, with 0 = excellent, 1 = good, 2 = fair, 3 = poor, 4 = none. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a value at Week 6 and Week 12 for the Investigator Global Assessment of Response to Therapy.|||Score on a Scale||Standard Error|Least Squares Mean
2663236|NCT01554163|Secondary|Time-Weighted Mean Change From Baseline in the WOMAC Stiffness Subscale|The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The stiffness subscale rates stiffness after first waking and later in the day using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of stiffness and 100 is the highest level of stiffness. The stiffness subscale is calculated as the average of the responses to the 2 questions related to stiffness. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline, Week 2, Week 6, Week 12|The population consisted of all paricipants that received one dose of study medication and had a baseline value for the WOMAC stiffness subscale, and had at least one post-randomization observation.|||Score on a Scale||Standard Error|Least Squares Mean
2663237|NCT01554163|Secondary|Time-Weighted Mean Change From Baseline in the Investigator Global Assessment of Disease Status|Study investigators were asked to rate the global assessment of participant disease status on a Likert scale from 0 to 4, with 0 = very well, 1 = good, 2 = fair, 3 = poor and 4 = very poor. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline, Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a baseline value for the Investigator Global Assessment of Disease Status, and had at least one post-randomization observation.|||Score on a Scale||Standard Error|Least Squares Mean
2663238|NCT01554163|Secondary|Time-Weighted Mean Response in the Participant Global Assessment of Response to Therapy|Participants were asked to rate their global assessment of response to therapy on a Likert scale from 0 to 4, with 0 = excellent, 1 = good, 2 = fair, 3 = poor, 4 = none. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a Week 2, Week 6, and Week 12 value for the Participant Global Assessment of Response to Therapy.|||Score on a Scale||Standard Error|Least Squares Mean
2663239|NCT01554163|Secondary|Time-Weighted Mean Change From Baseline in the Participant Global Assessment of Disease Status|"The Participant Global Assessmet of Disease was a one item questionnaire that asked participants to answer the following question, Considering all the ways your arthritis affects you, mark (X) on the scale for how well you are doing. The questionnaire employed a 0-100 mm visual analog scale (VAS) to record participant responses, with 0 representing the best possible assessment and 100 representing the worst possible assessment. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average."|Baseline, Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a baseline value for the Participant Global Assessment of Disease Status, and had at least one post-randomization observation.|||Score on a Scale||Standard Error|Least Squares Mean
2663240|NCT01554163|Secondary|Time-Weighted Mean Change From Baseline in the WOMAC Physical Function Subscale|The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The physical function subscale rates participant pain during stair use, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/taking off socks, rising from bed, lying in bed, getting in/out of the bath, sitting, getting on/off the toilet, heavy household duties, and light household duties using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of functioning and 100 is the highest level of functioning. The physical function subscale was calculated as the average of the responses to the 17 questions related to functional status. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline, Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a baseline value for the WOMAC physical function subscale, and had at least one post-randomization observation.|||Score on a Scale||Standard Error|Least Squares Mean
2663241|NCT01554163|Primary|Time-Weighted Mean Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale|The WOMAC osteoarthritis scale consists of 24 items in 3 subscales: pain, stiffness, and physical function. The pain subscale rates participant pain during walking, using stairs, in bed, sitting or lying, and standing using a visual analog scale (VAS) from 0-100mm where 0 is the best possible level of pain and 100 is the highest level of pain. The pain subscale is calculated as the average of the responses to the 5 questions related to pain. The calculation of the time-weighted average was done by taking the time between adjacent observations divided by the time from the randomization visit to the last observation in the period of interest, and using it as the weight for computation of the average.|Baseline, Week 2, Week 6, Week 12|The population consisted of all participants that received one dose of study medication and had a baseline value for the WOMAC pain subscale, and had at least one post-randomization observation.|||Score on a Scale||Standard Error|Least Squares Mean
2663242|NCT01553916|Secondary|Rate of Overall Survival|-Overall survival is defined as the time between date of on study and date of death due to any cause|12 months|7 participants were not evaluable for this outcome measure|||Participants|||Count of Participants
2663243|NCT01553916|Secondary|Number of Central Nervous System (CNS) Adverse Events|Adverse events will be tabulated by type and grade using NCI CTCAE v 4.|Through 12 months||||CNS adverse events|||Number
2663244|NCT01553916|Secondary|Number of Participants With Brain Metastases|1-year rate of brain metastases|12 months|7 participants were not evaluable for this outcome measure|||Participants|||Count of Participants
2663245|NCT01553916|Secondary|Change in Hippocampal Morphology Following Lithium + PCI as Measured by Total Hippocampal Volume||Baseline through 12 months|"10 participants were evaluable for this outcome measure~Originally the outcome measure time frame was baseline through 12 months but there was insufficient data to statistically analyze the change in hippocampal morphology at 12 months due to the number of participants still alive for the 12 month scan."|||cc||Full Range|Median
2663246|NCT01553916|Secondary|Feasibility of Performing Serial Neurocognitive Testing and Quality of Life Exams as Measured by Number of Patients Who Complete the Neurocognitive Testing and Quality of Life Exams|-Defined as at least 4 of 6 patients successfully completing pre-treatment and 3 month post-treatment testing|3 months|(1) participant is not evaluable as the participant did not start treatment due to pre-treatment MRI showing metastatic disease in spine.|||Participants|||Count of Participants
2663247|NCT01553916|Secondary|Changes in Quality-of-life as Measured by Overall Quality of Life Using the Total Score of the EORTC QLQ-BN20|"Assessed by comparing questionnaire test scores to baseline; BN20 (future uncertainty and communications deficit scales)~20 questions with answers ranging from 1-4 with 1=not at all and 4=very much~Raw scores will be transformed to a 100-point scale (0=lowest score, 100=highest score)~The higher the score the lower quality of life"|12 months|5 participants were not evaluable for this outcome measure|||scores on a scale||Standard Deviation|Mean
2663248|NCT01553916|Secondary|Changes in Quality-of-life as Measured by Overall Quality of Life Using the EORTC QLQ30|"Assessed by comparing questionnaire test scores to baseline; European Organization for Research and Treatment of Cancer (EORTC) QLQ30 (global health/QOL, cognitive functioning, and fatigue scales)~30 total questions with 28 questions having answers ranging from 1-4 with 1=not at all and 4= very much and 2 questions ranging from 0-7 with 1-very poor and 7=excellent~Raw scores will be transformed to a 100-point scale (0=lowest score, 100=highest score)~The higher the score the lower the quality of life"|3 months|5 participants were not analyzed for this outcome measure|||scores on a scale||Standard Deviation|Mean
2663249|NCT01553916|Secondary|Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score|"The HVLT is a word learning test measuring episodic visual memory~The delayed recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages)~The words were read aloud and the participants was asked to freely recall them 20-25 minutes later.~The words recalled were recorded and a total recall score tallied (range: 0-36).~The higher the score the better the recall"|12 months|13 participants were not evaluable for this outcome measure|||scores on a scale||Standard Deviation|Mean
2663466|NCT01552369|Secondary|Neutropenia|Incidence of neutropenia less than 1000/µL while on valganciclovir treatment|Day 1 through Day 107|ITT population|||Participants|||Count of Participants
2663250|NCT01553916|Secondary|Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score|"The HVLT is a word learning test measuring episodic visual memory~The delayed recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages)~The words were read aloud and the participants was asked to freely recall them 20-25 minutes later.~The words recalled were recorded and a total recall score tallied (range: 0-36).~The higher the score the better the recall"|6 months|11 participants were not evaluable for this outcome measure|||scores on a scale||Standard Deviation|Mean
2663251|NCT01553916|Secondary|Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score|"The HVLT is a word learning test measuring episodic visual memory~The delayed recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages)~The words were read aloud and the participants was asked to freely recall them 20-25 minutes later.~The words recalled were recorded and a total recall score tallied (range: 0-36).~The higher the score the better the recall"|3 months|-8 participants were not evaluable for this outcome measure|||scores on a scale||Standard Deviation|Mean
2663252|NCT01553916|Secondary|Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score|"The HVLT is a word learning test measuring episodic visual memory~The immediate recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages)~The words were read aloud and the participants was asked to freely recall them immediately. The list was read a second time followed by a second free recall trial. This was followed by a third reading and third free recall.~The words recalled for each trial were recorded and a total recall score tallied (range: 0-36).~The higher the score the better the recall"|12 months|13 participants were not evaluable for this outcome measure|||scores on a scale||Standard Deviation|Mean
2663253|NCT01553916|Secondary|Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score|"The HVLT is a word learning test measuring episodic visual memory~The immediate recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages)~The words were read aloud and the participants was asked to freely recall them immediately. The list was read a second time followed by a second free recall trial. This was followed by a third reading and third free recall.~The words recalled for each trial were recorded and a total recall score tallied (range: 0-36).~The higher the score the better the recall"|6 months|11 participants were not evaluable for this outcome measure|||scores on a scale||Standard Deviation|Mean
2663254|NCT01553916|Primary|Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score|"The HVLT is a word learning test measuring episodic visual memory~The immediate recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages)~The words were read aloud and the participants was asked to freely recall them immediately. The list was read a second time followed by a second free recall trial. This was followed by a third reading and third free recall.~The words recalled for each trial were recorded and a total recall score tallied (range: 0-36).~The higher the score the better the recall"|3 months|6 participants were not evaluable for this outcome measure|||scores on a scale||Standard Deviation|Mean
2663255|NCT01553916|Primary|Safety of Lithium Carbonate as Measured by Number of Patients in the Safety lead-in Who Experienced a Dose-limiting Toxicity (DLT)|-Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4. Safety will be defined as < 2 patients experiencing DLTs of the first 6 treated.|3 weeks|-Only patients enrolled in the safety lead-in were evaluable for this outcome measure|||Participants|||Count of Participants
2663256|NCT01553851|Secondary|Percent of Participants With Metabolic Changes in OCSCC Using FDG-PET/CT Imaging.|Intratumarol metabolic changes were evaluated by changes in in SUVmax in the primary tumor; quantitative analysis SUVmax with the primary tumor site was determined within a volume of interest around the tumor using a Siemens eSoft workstation.|Baseline and Day 14|Seven patients did not meet protocol-defined tumor size criteria (n=3), withdrew from study (n=3) or declined post GSK1120212 FDG-PET/CT(n=1)|||percentage of participants|||Number
2663257|NCT01553851|Secondary|Percent Change in Tumor Size Area||Baseline and Day 15|Quantitative changes in tumor size based on clinical examination of area of tumor at baseline and after GSK1120212 based on two dimensional measurements.|||percent change in tumor size area||Full Range|Median
2663258|NCT01553851|Secondary|Safety of GSK1120212|Number of adverse events were monitored for 30 day following last dose of GSK1120212|1st 4-6 week follow-up visit||||Adverse events|||Number
2663259|NCT01553851|Secondary|Percent Change in Maximum Standard Uptake Value in Oral Cavity Saqumous Cell Carcinoma (OCSCC) Using F18-Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography (FDG-PET/CT).||Baseline and Day 14|Seven patients did not meet protocol-defined tumor size criteria (n=3), withdrew from study (n=3) or declined post GSK1120212 FDG-PET/CT(n=1)|||percentage change in SUVmax||Full Range|Median
2663260|NCT01553851|Secondary|Flow Cytometric Analysis of the Peripheral Blood and Tumor.|"Peripheral blood - baseline and Day 14~Tumor - baseline and Day 15"|Baseline, Day 14, and Day 15|There was an insufficient amount of tissue to collected. The data was not collected and the outcome measure was not analyzed.||||||
2663261|NCT01553851|Secondary|Percentage of Participants With Clinical Response Induced by GSK1120212, as Determined by Change in Tumor Size.|Clinical Response was evaluted by quantitative changes in tumor size based on clinical examination of area of tumor at baseline and after GSK1120212 based on two dimensional measurements.|Baseline and Day 15||||percentage of participants|||Number
2663262|NCT01553851|Secondary|Tumor Specific Findings for Pathologic Changes Including Proliferation (Ki-67 Staining), Tumor Vasculature Staining (Microvessel Density), ERK1/2 Mediated Changes in p27 (Kip1) & Flow Cytometric Analysis of the Peripheral Blood & Tumor.||Baseline and Day 15|There was an insufficient amount of tissue to collected. The data was not collected and the outcome measure was not analyzed.||||||
2663265|NCT01553747|Secondary|Change From Baseline in IBS-QoL Total Scores|The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation. A positive change from Baseline indicates that quality of life improved.|Baseline, Weeks 4, 8, 12, 18, 26 and 30/EOT|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||score on a scale||Standard Deviation|Mean
2663266|NCT01553747|Secondary|Number of Urgency Episodes Per Day|Participants recorded the number of urgency episodes over 24 hours daily throughout the treatment.|Weeks 4, 12 and 26|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||episodes per day||Standard Deviation|Mean
2663267|NCT01553747|Secondary|Number of Bowel Incontinence Free Days|An incontinence free day was one where the participant reports zero incontinence episodes. The number of incontinence free days for a participant was assessed each week based on the number of reported days.|Weeks 4, 12 and 26|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||days||Standard Deviation|Mean
2663268|NCT01553747|Secondary|Number of Bowel Incontinence Episodes|Participants recorded the number of incontinence episodes over 24 hours daily throughout the treatment.|Weeks 4, 12 and 26|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||incontinence episodes||Standard Deviation|Mean
2663269|NCT01553747|Secondary|Number of Bowel Movements Per Day|Participants recorded the number of bowel movements over 24 hours daily throughout the treatment.|Weeks 4, 12 and 26|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||bowel movements per day||Standard Deviation|Mean
2663270|NCT01553747|Secondary|Change From Baseline in Daily Abdominal Bloating Scores|Symptoms of abdominal bloating were recorded on a 0 to 10 scale, where 0 corresponded to no bloating and 10 corresponded to worst imaginable bloating. A negative change from Baseline indicates the bloating decreased.|Baseline, Weeks 4, 12 and 26|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||score on a scale||Standard Deviation|Mean
2663271|NCT01553747|Secondary|Change From Baseline in Daily Abdominal Discomfort Scores|Symptoms of abdominal discomfort were recorded on a 0 to 10 scale, where 0 corresponded to no discomfort and 10 corresponded to worst imaginable discomfort. A negative change from Baseline indicates the discomfort decreased.|Baseline, Weeks 4, 12 and 26|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||score on a scale||Standard Deviation|Mean
2663272|NCT01553747|Secondary|Percentage of Participants With Irritable Bowel Syndrome - Adequate Relief (IBS-AR) Scale|"Adequate relief of IBS symptoms was assessed once weekly by participants answering the IBS-AR item in the electronic diary. IBS-AR responders were defined as participants with a weekly response of Yes to adequate relief of their IBS symptoms for at least 50% of the total weeks during the interval. A participant must have had a positive response on ≥6 weeks for the 12-week interval and ≥13 weeks for the 26-week interval, regardless of diary compliance, to be a responder."|12-week interval (Weeks 1-12) and 26-week interval (Weeks 1-26)|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
2663273|NCT01553747|Secondary|Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale|IBS-QoL responders were defined as participants who achieved at least a 14-point improvement in IBS-QoL total score from baseline to the applicable visit. The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100-point (0= worst; 100=better) scale for ease of interpretation.|Weeks 4, 8, 12, 18, 26 and 30 (End of Treatment [EOT])|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
2663274|NCT01553747|Secondary|Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals|IBS-d global symptom responders were defined as those participants who met the daily IBS-d global symptom response criteria (ie, IBS-d global symptom score of 0 [none] or 1 [mild]; or a daily IBS-d global symptom score improved by ≥2.0 compared to the baseline average) for at least 50% of days with diary entries during each interval. IBS-d Global Symptom Scale was a 5-point scale, score ranging from 0 to 4. 0= no symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms and 4 = very severe symptoms. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder.|12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
2663304|NCT01553318|Primary|Change From Baseline in Weekly Average Pain Score on the Visual Analog Scale at Week 10|Change in weekly average pain score from baseline to week 10 (range from -10 to +10): interpretation= the more negative the value is, the larger reduction in pain severity at week 10 is|baseline and week 10||||units on a scale||Standard Deviation|Mean
2663275|NCT01553747|Secondary|Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals|Stool consistency responders: Participants who met daily stool consistency response criterion (ie,score of 1, 2, 3, or 4 or absence of bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain) for at least 50% of days with diary entries during each interval. BSS was defined as 7-point Scale in which score of 1= separate hard lumps, 2= sausage shaped but lumpy, 3= sausage-like with cracks on the surface, 4= sausage-like but smooth and soft, 5= soft blobs with clear cut edges, 6= fluffy pieces with ragged edges, and 7= watery with no solid pieces. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over 12-week interval, and a minimum of 110 days of diary entries over 26-week interval to be a responder.|12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
2663276|NCT01553747|Secondary|Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals|Pain responders were defined as participants who met the daily pain response criteria (ie, the worst abdominal pain score in the past 24 hours improved by ≥30% compared to baseline) for at least 50% of days with diary entries during each interval. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder.|12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
2663277|NCT01553747|Secondary|Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores|Composite responders were defined as participants who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.|Up to 26 weeks|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
2663278|NCT01553747|Primary|Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain and Daily Stool Consistency Scores|Composite responders were defined as participants who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.|Up to 12 weeks|Intention-to-treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
2663279|NCT01553708|Secondary|Clinical Safety of Epidermal Growth Factor With Silver Sulfadiazine Cream for Treatment of Partial Thickness Burn Wound.|"Pain and itching assessment is evaluated by patients themselves in every time of wound observations using Visual Analog Scale.~% Wound contraction.~Time and type of analgesic or itching medication after treatment.~Laboratory measurement such as CBC, blood glucose, electrolyte, hepatic and renal functions will be analyzed to find any changes or any systemic effect after treatment.~Adverse reaction such as swelling, edema and redness at wound site."|On 28th day after admission|||||||
2663280|NCT01553708|Primary|Time of Healing by Monitoring Duration (Days) at the Beginning of Treatment and the Day of Completely Epithelialization (Complete Epithelialization Means no Open Wound Exists as Confirmed by Two Surgeons).|Time (days)for complete epithelialization (no open wound exists as determined by 2 surgeons) is the duration between the day of admission and the wound completely close without fluid leakage and are able to expose to environment without pain.|On 28th day after admission||||Days||Standard Deviation|Mean
2663281|NCT01553591|Secondary|Change From Baseline in IBS-QoL Total Scores|The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation. A positive change from Baseline indicates that quality of life improved.|Baseline, Weeks 4, 8, 12, 18, 26, 36, 44, and 52/EOT|Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||score on a scale||Standard Deviation|Mean
2663305|NCT01553292|Secondary|Needs for Intubation During the Procedure|The needed for interruption or stop of ECALMIST to give PPV (positive pressure ventilation or mechanical ventilation though intubation by ETT (endotracheal intubation)|10 minutes|The number of preterm infants that needed intubation by ETT (endotracheal intubation) during ECALMIST|||Number of participants|||Number
2663467|NCT01552369|Secondary|Major Non-CMV Viral Infections|Incidence of non-CMV viral infections|Up to 365 days post-transplant||||Participants|||Count of Participants
2663282|NCT01553591|Secondary|IBS-QoL Total Scores|The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100- point scale (0=worst; 100=better) for ease of interpretation.|Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (EOT)|Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||score on a scale||Standard Deviation|Mean
2663283|NCT01553591|Secondary|Number of Urgency Episodes Per Day|Participants recorded the number of urgency episodes over 24 hours daily throughout the treatment.|Weeks 4, 12 and 26|Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||episodes per day||Standard Deviation|Mean
2663284|NCT01553591|Secondary|Number of Bowel Incontinence Free Days|An incontinence free day was one where the participant reports zero incontinence episodes. The number of incontinence free days for a participant was assessed each week based on the number of reported days.|Weeks 4, 12 and 26|Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||days||Standard Deviation|Mean
2663285|NCT01553591|Secondary|Number of Bowel Incontinence Episodes|Participants recorded the number of incontinence episodes over 24 hours daily throughout the treatment.|Weeks 4, 12 and 26|Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||incontinence episodes||Standard Deviation|Mean
2663286|NCT01553591|Secondary|Number of Bowel Movements Per Day|Participants recorded the number of bowel movements over 24 hours daily throughout the treatment.|Weeks 4, 12 and 26|Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||bowel movements per day||Standard Deviation|Mean
2663287|NCT01553591|Secondary|Change From Baseline in Daily Abdominal Bloating Scores|Symptoms of abdominal bloating were recorded on a 0 to 10 scale, where 0 corresponded to no bloating and 10 corresponded to worst imaginable bloating. A negative change from Baseline indicates the bloating decreased.|Baseline, Weeks 4, 12 and 26|Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||score on a scale||Standard Deviation|Mean
2663288|NCT01553591|Secondary|Change From Baseline in Daily Abdominal Discomfort Scores|Symptoms of abdominal discomfort were recorded on a 0 to 10 scale, where 0 corresponded to no discomfort and 10 corresponded to worst imaginable discomfort. A negative change from Baseline indicates the discomfort decreased.|Baseline, Weeks 4, 12 and 26|Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment. Here, number analyzed is the participants who were evaluable at specific time point.|||score on a scale||Standard Deviation|Mean
2663289|NCT01553591|Secondary|Percentage of Participants With Irritable Bowel Syndrome - Adequate Relief (IBS-AR) Scale|"Adequate relief of IBS symptoms was assessed once weekly by participants answering the IBS-AR item in the electronic diary. IBS-AR responders were defined as participants with a weekly response of Yes to adequate relief of their IBS symptoms for at least 50% of the total weeks during the interval. A participant must have had a positive response on ≥6 weeks for the 12-week interval and ≥13 weeks for the 26-week interval, regardless of diary compliance, to be a responder."|12-week interval (Weeks 1-12) and 26-week interval (Weeks 1-26)|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
2663290|NCT01553591|Secondary|Percentage of Participants Who Were Responders to the Irritable Bowel Syndrome Quality of Life Measure (IBS-QoL) Scale|IBS-QoL responders were defined as participants who achieved at least a 14-point improvement in IBS-QoL total score from baseline to the applicable visit. The IBS-QoL consists of 34 items each with a 5-point response scale, where 1 generally represents better responses on items and 5 represents worse responses. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0- to 100-point (0= worst; 100=better) scale for ease of interpretation.|Weeks 4, 8, 12, 18, 26, 36, 44, and 52 (End of Treatment [EOT])|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
2663291|NCT01553591|Secondary|Percentage of Participants Who Were Responders In Irritable Bowel Syndrome, Diarrhea Predominant (IBS-d) Global Symptom Scale by Intervals|IBS-d global symptom responders were defined as those participants who met the daily IBS-d global symptom response criteria (ie, IBS-d global symptom score of 0 [none] or 1 [mild]; or a daily IBS-d global symptom score improved by ≥2.0 compared to the baseline average) for at least 50% of days with diary entries during each interval. IBS-d Global Symptom Scale was a 5 point scale, score ranging from 0 to 4. 0= no symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms and 4 = very severe symptoms. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder.|12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
2663306|NCT01553292|Secondary|Oxygen Requirements After the Procedure|Oxygen requirement is expressed as proportion out of one (decimal) which is equal to percentage of 100. The measurment can be any where between 0.21 to 1 and this equal to percentage of 21-100%.|4 hours|The mean of oxygen level (proportion) of all participant after ECALMIST|||Proportion of oxygen saturation||Standard Deviation|Mean
2663292|NCT01553591|Secondary|Percentage of Participants Who Were Responders In Daily Stool Consistency Scores by Intervals|Stool consistency responders: participants who met daily stool consistency response criterion (ie,score of 1, 2, 3, or 4 or absence of bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain) for at least 50% of days with diary entries during each interval. BSS was defined as 7-point Scale in which score of 1= separate hard lumps, 2= sausage shaped but lumpy, 3= sausage-like with cracks on the surface, 4= sausage-like but smooth and soft, 5= soft blobs with clear cut edges, 6= fluffy pieces with ragged edges, and 7= watery with no solid pieces. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over 12-week interval, and a minimum of 110 days of diary entries over 26-week interval to be a responder.|12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
2663293|NCT01553591|Secondary|Percentage of Participants Who Were Pain Responders In Daily Worst Abdominal Pain Scores by Intervals|Pain responders were defined as participants who met the daily pain response criteria (ie, the worst abdominal pain score in the past 24 hours improved by ≥30% compared to baseline) for at least 50% of days with diary entries during each interval. A participant must have had a minimum of 20 days of diary entries over any 4-week interval, a minimum of 60 days of diary entries over the 12-week interval, and a minimum of 110 days of diary entries over the 26-week interval to be a responder.|12-week interval (Weeks 1-12), 26-week interval (Weeks 1-26), and 4-week interval (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, and 21-24)|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
2663294|NCT01553591|Secondary|Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores|Composite responders were defined as a participant who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.|Up to 26 Weeks|ITT analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
2663295|NCT01553591|Primary|Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores|Composite responders were defined as a participant who met the daily response criteria for at least 50% of the days with diary entries during the interval of interest. A participant must had met both of the following criteria on a given day to be a daily responder: 1) Daily pain response: worst abdominal pain scores in the past 24 hours improved by ≥30% compared to baseline (average of daily worst abdominal pain the week prior to randomization). 2) Daily stool consistency response: Bristol Stool Scale (BSS) score <5 (ie, score of 1, 2, 3, or 4) or the absence of a bowel movement if accompanied by ≥30% improvement in worst abdominal pain compared to baseline pain. Bristol stool scale was defined as 7-point Scale in which a score of 1 = separate hard lumps, 2 = sausage shaped but lumpy, 3 = sausage-like with cracks on the surface, 4 = sausage-like but smooth and soft, 5 = soft blobs with clear cut edges, 6 = fluffy pieces with ragged edges, and 7 = watery with no solid pieces.|Up to 12 Weeks|Intent to Treat (ITT) analysis set included all participants who were randomized into a treatment group and presents data for participants according to their randomization assignment.|||percentage of participants|||Number
2663296|NCT01553539|Secondary|Plasma Levels of Angiogenic Peptides Including Placental Growth Factor (PlGF)||Baseline and Day 22||||pg/mL||Standard Deviation|Median
2663297|NCT01553539|Secondary|Overall Survival||Approximately 5 years||||months||95% Confidence Interval|Median
2663298|NCT01553539|Secondary|Time to Disease Progression||Approximately 5 years||||months||95% Confidence Interval|Median
2663299|NCT01553539|Primary|Number of Participants Who Experienced Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|See the adverse event tables for specifics.|Approximately 1 year||||Participants experiencing adverse events|||Number
2663300|NCT01553539|Primary|Antitumor Activity as Assessed by Number of Patients Showing an Objective Tumor Response|'Activity' will be operationalized using objective tumor response, which will be estimated as the proportion of partial and complete responders (according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria) among all evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Approximately 1 year||||participants|||Number
2663301|NCT01553318|Secondary|Change From Baseline in the Blood Levels of IL-8, MCP-1 and Eotaxin at Week 10|Change in peripheral blood levels of IL-8, MCP-1 and Eotaxin from baseline to week 10|baseline and week10|We do not have data on the chemokines because of the problems we had with the assays. Indeed, IL-8, MCP-1 and Eotaxin were all secondary outcomes.||||||
2663302|NCT01553318|Secondary|Fibromyalgia Impact Questionnaire|Change in global symptom severity [scale range from -100 to +100] = the more negative the value is, the greater the improvement in overall symptom severity|baseline and week 10|Indeed, fibromyalgia impact questionnaire is a secondary outcome.|||units on a scale||Standard Deviation|Mean
2663303|NCT01553318|Secondary|Change From Baseline in Evoked Pain Score at Week 10|Change in evoked pain score from baseline to week 10 (scale range -20 to +20): interpretation= the more negative the value is, the larger the reduction in sensitivity to pressure pain stimuli|baseline and week 10||||units on a scale||Standard Deviation|Mean
2663307|NCT01553292|Secondary|Oxygen Saturation Before the Procedure|Oxygen saturation is measured by pulse oximetry and express as proportion out of one which equal to percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.|1 hour|The mean of saturation of all participants before ECALMIST|||Proportion of oxygen saturation||Standard Deviation|Mean
2663308|NCT01553292|Secondary|CPAP Pressure Before the Proceudre|Continuous positive airway pressure (CPAP) pressure is measured in centimeter of water as recorded from CPAP machine (continuous positive airway pressure)|1 hour|The mean of CPAP pressure that is measured by centimeter of water of all the participant before ECALMIST|||Centimeter of water||Standard Deviation|Mean
2663309|NCT01553292|Secondary|Index After the Procedure|"The index is an arbitrary number calculated by equation that is author defined which is(FiO2 * CPAP/ Sat)*100.~FiO2: Fraction of inspired oxygen CPAP: continuous positive airway pressure Sat: saturation The equation is similar to the Oxygen index (OI) equation with replacement of Mean airway pressure (MAP) by continuous positive airway pressure (CPAP. It comprehensive view about the 3 parameters (FiO2, CPAP and Sat) during the procedure."|4 hours|The mean of ECALMIST index of all the participants after ECALMIST|||Score||Standard Deviation|Mean
2663310|NCT01553292|Secondary|Oxygen Saturation After the Procedure|Oxygen saturation is measured by pulse oximetry. It is express as proportion out of 1 (decimal) that is equal to percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.|4 hours|The mean of oxygen saturation after ECALMIST for all the participants|||Proportion of oxygen saturation||Standard Deviation|Mean
2663311|NCT01553292|Secondary|Oxygen Requirement Before the Procedure|Oxygen requirement or FiO2 (Fraction of inspired oxygen) is expressed as proportion out of one (decimal) or percentage of 100. The number can be any where between 0.21 to 1 which is equal to percentage of 21 to 100.|1 hour|The mean of oxygen requirement of all the participants before ECALMIST|||Proportion of oxygen requirement||Standard Deviation|Mean
2663312|NCT01553292|Secondary|CPAP Pressure After the Procedure|Continuous positive airway pressure (CPAP) is measured in centimeter of water|4 hours|The mean of CPAP pressure express as centimeter of water of all participants after completion of ECALMIST|||Centimeter of water||Standard Deviation|Mean
2663313|NCT01553292|Secondary|Index Before the Procedure|"The index is an arbitrary number calculated by equation that is author defined which is(FiO2 * CPAP/ Sat)*100.~FiO2: Fraction of inspired oxygen CPAP: continuous positive airway pressure Sat: saturation The equation is similar to the Oxygen index (OI) equation with replacement of Mean airway pressure (MAP) by continuous positive airway pressure (CPAP. It comprehensive view about the 3 parameters (FiO2, CPAP and Sat) during the procedure."|1 hour|The mean of index of all participants before ECALMIST|||Score||Standard Deviation|Mean
2663314|NCT01553292|Primary|Incidence of Early Ventilation Hours|The need for mechanical ventilation due to various reasons like sepsis, Apnea (pause of respiration for more than 20 seconds) or Respiratory dysfunction evidenced by abnormal blood gas or desaturation or increase work of breathing|72 hours|The number of preterm infants that need intubation by ETT within 72 hours of life(early ventilation). This is includes all infants intubated whether during or after the ECALMIST procedure in the 1st 3 days of life (after delivery)|||Number of participants|||Number
2663315|NCT01553292|Secondary|Failure to Catheterized the Trachea by the Vascular Catheter|Failure define as inability to pass the vascular catheter to the trachea after 2 trials within 20 seconds time frame for each trial.|20 seconds|Number of infatns that failed to pass the angiocath to the trachea after 2 trials, 20 seconds each trial.|||Number of participants|||Number
2663316|NCT01553292|Secondary|Saturation During the Procedure|Level of oxygen which is measured by oxygen pulse Oximetry. It is express as proportion out of one which is equal to percentage of 100. The number can be anywhere between 0.21 to 1 which is equal to percentage of 21 to 100.|10 minutes|The mean of oxygen saturation of all participants during ECALMIST(measured by minutes which is variable according participant tolerance of the ECALMIST procedure)|||Proportion of oxygen saturation||Standard Deviation|Mean
2663317|NCT01553292|Secondary|Incidence of Bradycardia During Procedure|Bradycardia is persistent heart rate below 100 beat per minute for more than 20 seconds during the procedure as seen by the monitor or Heart rate below 60 beat per minute for any time if chest compression is needed or if associated with desaturation or apnea.|Range of 10 minutes|The mean of heart beat per minute of all participants during ECALMIST(measured by minutes which is variable according participant tolerance of the ECALMIST procedure)|||Number of participants|||Number
2663318|NCT01553279|Secondary|Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Part 1]|An SAE is an event that results in death; is life-threatening; results in or prolongs hospitalization; is a congenital anomaly/birth defect; is a cancer; is an overdose; or is another important medical event that may jeopardize the participant.|Up to 4.5 months (up to 15 days after the final Part 1 vaccination)|All randomized participants who received ≥1 dose of study medication in Part 1 are included.|||Percentage of Participants||95% Confidence Interval|Number
2663319|NCT01553279|Secondary|Percentage of Participants Experiencing Increased Temperature [Part 1]|The percentage of participants experiencing temperatures ≥38.0° Celsius (C), >38.5° C, and >39.5° C following any Part 1 vaccination was determined.|Up to 4.5 months (up to 15 days after the final Part 1 vaccination)|All randomized participants who received ≥1 dose of study medication in Part 1 are included.|||Percentage of Participants|||Number
2663320|NCT01553279|Secondary|Percentage of Participants Experiencing a Solicited Systemic Adverse Event (AE) [Part 1]|The percentage of participants with solicited systemic AEs was determined for each arm. Solicited systemic AEs consisted of crying, decreased appetite, irritability, pyrexia, somnolence, and vomiting.|Up to 4.5 months (up to 15 days after the final Part 1 vaccination)|All randomized participants who received ≥1 dose of study medication in Part 1 are included.|||Percentage of Participants|||Number
2663321|NCT01553279|Secondary|Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)|The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs consisted of bruising, dermatitis, erythema, induration, mass, pain, rash, and warmth.|Up to 4.5 months (up to 15 days after the final Part 1 vaccination)|All randomized participants who received ≥1 dose of study medication in Part 1 are included.|||Percentage of Participants|||Number
2663345|NCT01553240|Secondary|Vineland Maladaptive Behavior Scale||during screening|P.I. has left the institution and NYSPI has no access to the data. Results will not be analyzed or presented.||||||
2663322|NCT01553279|Secondary|Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the MCC-TT or MCC-CRM Injection Site (Part 1)|The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling.|Up to 4.5 months (up to 15 days after the final Part 1 vaccination)|All randomized participants who received ≥1 dose of study medication in Part 1 are included.|||Percentage of Participants||95% Confidence Interval|Number
2663323|NCT01553279|Secondary|Percentage of Participants Experiencing an Unsolicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)|The percentage of participants with unsolicited ISRs was determined for each arm. Unsolicited ISRs were any injection-site ISRs not considered solicited.|Up to 4.5 months (up to 15 days after the final Part 1 vaccination)|All randomized participants who received ≥1 dose of study medication in Part 1 are included.|||Percentage of Participants||95% Confidence Interval|Number
2663324|NCT01553279|Secondary|Percentage of Participants Experiencing a Solicited Injection Site Reaction (ISR) at the V419 Injection Site (Part 1)|The percentage of participants with solicited ISRs was determined for each arm. Solicited ISRs consisted of injection site pain, erythema, and swelling.|Up to 4.5 months (up to 15 days after the final Part 1 vaccination)|All randomized participants who received ≥1 dose of study medication in Part 1 are included.|||Percentage of Participants||95% Confidence Interval|Number
2663325|NCT01553279|Secondary|Percentage of Participants Experiencing an Injection Site (Vaccine-Related) Systemic Adverse Event (AE) [Part 1]|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. As per protocol, all injection site AEs were considered vaccine-related.|Up to 4.5 months (up to 15 days after the final Part 1 vaccination)|All randomized participants who received ≥1 dose of study medication in Part 1 are included.|||Percentage of Participants||95% Confidence Interval|Number
2663326|NCT01553279|Secondary|Percentage of Participants Experiencing an Adverse Event (AE) [Part 1]|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product.|Up to 4.5 months (up to 15 days after the final Part 1 vaccination)|All randomized participants who received ≥1 dose of study medication in Part 1 are included.|||Percentage of Participants||95% Confidence Interval|Number
2663327|NCT01553279|Secondary|Geometric Mean Titres (GMTs) for Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) One Month After Anti-Haemophilus Influenzae Type B (HiB) MCC Vaccination (Part 2)|Anti-PRP Ab GMTs were determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA) and are expressed as µg/mL..|Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)|All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.|||µg/mL||95% Confidence Interval|Geometric Mean
2663328|NCT01553279|Secondary|Percentage of Participants With Anti-Polyribosylribitol Phosphate (PRP) Antibody (Ab) Titres ≥0.15 µg/mL and ≥1.0 µg/mL One Month After Anti-Haemophilus Influenzae Type B MCC Vaccination (Part 2)|The percentage of participants with anti-PRP Ab titres ≥0.15 µg/mL and ≥1.0 µg/mL was determined prior to, and 1 month after, administration of the anti-Hib vaccination at Month 12. Anti-PRP Ab titres were measured with radioimmunoassay (RIA).|Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)|All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.|||Percentage of Participants||95% Confidence Interval|Number
2663329|NCT01553279|Secondary|Antibody (Ab) Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Meningococcal Serogroup C (MCC) Vaccination (Part 2)|Antibody GMTs were were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.|Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)|All randomized and treated participants with data available, who had no protocol violations that could interfere with results, and received all Part 1 vaccinations are included.|||tire (1/dil)||95% Confidence Interval|Geometric Mean
2663330|NCT01553279|Secondary|Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8(1/Dil) and Titre ≥1:28 (1/Dil) One Month After Anti-Haemophilus Influenzae Type B (Anti-Hib) Vaccination (Part 2)|The percentage of participants with anti-Hib Ab titres ≥1:8 (1/dil) and ≥1:28 (1/dil) were determined prior to, and 1 month after, administration of the single HiB-MCC vaccine at 12 months of age. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.|Month 12 and Month 13 (Prior to anti-Hib MCC and 1 month after anti-HiB MCC)|All randomized and treated participants with data available, who had no protocol violations that could interfere with results, and received all Part 1 vaccinations are included.|||Percentage of Participants||95% Confidence Interval|Number
2663331|NCT01553279|Secondary|Antibody (Ab) Geometic Mean Titres (GMTs) for Polio Types 1, 2, and 3 One Month After V114 Dose 3 (Part 2)|The GMTs for polio types 1, 2, and 3 were determined for each arm. Antibody titres for polio types 1, 2, and 3 were measured by micrometabolic inhibition test (MIT).|Month 5 (1 month after V419 Dose 3)|All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.|||titre (1/dil)||95% Confidence Interval|Geometric Mean
2663332|NCT01553279|Secondary|Antibody (Ab) Geometic Mean Titres (GMTs) for Fimbrae Types 2 and 3 (FIM) One Month After V114 Dose 3 (Part 2)|The GMTs for FIM were determined for each arm. Antibody titres for FIM were measured by enhanced chemiluminescence (ECi) assay.|Month 5 (1 month after V419 Dose 3)|All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.|||EU/mL||95% Confidence Interval|Geometric Mean
2663333|NCT01553279|Secondary|Antibody (Ab) Geometic Mean Titres (GMTs) for Pertactin (PRN) One Month After V114 Dose 3 (Part 2)|The GMTs for PRN were determined for each arm. Antibody titres for PRN were measured by enhanced chemiluminescence (ECi) assay.|Month 5 (1 month after V419 Dose 3)|All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.|||EU/mL||95% Confidence Interval|Geometric Mean
2663334|NCT01553279|Secondary|Antibody (Ab) Geometic Mean Titres (GMTs) for Filamentous Haemagglutinin (FHA) One Month After V114 Dose 3 (Part 2)|The GMTs for FHA were determined for each arm. Antibody titres for FHA were measured by enhanced chemiluminescence (ECi) assay.|Month 5 (1 month after V419 Dose 3)|All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.|||EU/mL||95% Confidence Interval|Geometric Mean
2663335|NCT01553279|Secondary|Antibody (Ab) Geometic Mean Titres (GMTs) for Pertussis Toxoid (PT) One Month After V114 Dose 3 (Part 2)|The GMTs for PT Ab titres were determined for each arm. Antibody titres for PT were measured with enzyme-linked immunosorbent assay (ELISA).|Month 5 (1 month after V419 Dose 3)|All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.|||EU/mL||95% Confidence Interval|Geometric Mean
2663336|NCT01553279|Secondary|Antibody (Ab) Geometic Mean Titres (GMTs) for Tetanus One Month After V114 Dose 3 (Part 2)|The GMTs for tetanus Ab titres were determined for each arm. Antibody titres for tetanus were determined with enzyme-linked immunosorbent assay (ELISA).|Month 5 (1 month after V419 Dose 3)|All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.|||IU/mL||95% Confidence Interval|Geometric Mean
2663337|NCT01553279|Secondary|Antibody (Ab) Geometic Mean Titres (GMTs) for Diptheria One Month After V114 Dose 3 (Part 2)|The GMTs for diphtheria Ab titres were determined for each arm. Antibody titres for diptheria were measured by enhanced micrometabolic inhibition test (MIT).|Month 5 (1 month after V419 Dose 3)|All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.|||IU/mL||95% Confidence Interval|Geometric Mean
2663338|NCT01553279|Secondary|Antibody (Ab) Geometic Mean Titres (GMTs) for Hepatitis B Surface Antigen (HBsAg) One Month After V114 Dose 3 (Part 2)|The GMTs for HBsAg Ab titres were determined for each arm. Antibody titres for HBsAg were measured by enhanced chemiluminescence (ECi) assay.|Month 5 (1 month after V419 Dose 3)|All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.|||mIU/mL||95% Confidence Interval|Geometric Mean
2663339|NCT01553279|Secondary|Antibody (Ab) Geometic Mean Titres (GMTs) for Haemophilus Influenza Type B (Polyribosylribitol Phosphate [PRP]) One Month After V114 Dose 3 (Part 2)|The GMTs for PRP Ab titres were determined for each arm. Antibody titres for PRP were measured by radioimmunoassay (RIA).|Month 5 (1 month after V419 Dose 3)|All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.|||µg/mL||95% Confidence Interval|Geometric Mean
2663340|NCT01553279|Secondary|Antibody (Ab) Response Rates for V114 Antigens One Month After V114 Dose 3 (Part 1)|The percentage of participants meeting Ab response rates for V14 antigens was determined after V114 Dose 3. Antibody response rate criteria for Haemophilus influenza Type B (PRP); hepatitis B (HBsAg); diphtheria; tetanus; and polio types 1, 2, and 3 are shown in the rows below. The percentage of seroresponders to pertussis seroresponders (pertussis toxoid [PT]; filamentous haemagglutinin (FHA); fimbrae types 2 and 3 [FIM]; and pertactin [PRN]) was determined as 1) if pre-vaccination Ab concentration <lower limit of quantification (LLoQ) but post-vaccination Ab concentration ≥LLoQ; or 2) if pre-vaccination Ab concentration was ≥LLoQ but post-vaccination Ab concentration was ≥pre-immunization levels. Antibody titres were measured by RIA for PRP, enhanced chemiluminescence assay (ECi) for HBsAg, micrometabolic inhibition test (MIT) for diphtheria and poliovirus, and enzyme-linked immunosorbent assay (ELISA) for tetanus, PT, FHA, FIM, and PRN.|Month 5 (1 month after V419 Dose 3)|All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.|||Percentage of Participants||95% Confidence Interval|Number
2663341|NCT01553279|Secondary|Geometric Mean Titres (GMTs) for Meningococcal Serogroup C (MCC) One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)|Anti-MCC antibody GMTs were determined 1 month after MCC-TT or MCC-CRM Doses 1 and 2 in participants also treated with V419. Serum antibody levels were assayed using the Meningo C rabbit complement serum bactericidal antibody (rSBA) assay.|Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)|All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.|||Titres||95% Confidence Interval|Geometric Mean
2663342|NCT01553279|Secondary|Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil and ≥1:128 Dil One Month After MCC-TT or MCC-CRM Doses 1 and 2 (Part 1)|The percentage of participants with anti-MCC Ab titres ≥1:8 dil and ≥1:128 dil 1 month after MCC-TT or MCC-CRM Doses 1 and 2 was determined in participants also treated with V419. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.|Month 4 and Month 5 (1 month after MCC-TT/MCC-CRM Doses 1 and 2)|All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.|||Percentage of Participants||95% Confidence Interval|Number
2663343|NCT01553279|Secondary|Percentage of Participants With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody (Ab) Titre ≥0.15 µg/mL One Month After V419 Dose 3 (Part 1)|The acceptability (i.e., percentage of participants with anti-PRP Ab titre ≥0.15 µg/mL) of the seroprotection rate (SPR) to Haemophilus influenza type b (Hib) was determined 1 month after the third dose of V419 in participants also treated with MCC-TT or MCC-CRM. The pooled (i.e., all V419-treated participants) SPR was considered acceptable if the lower bound of the 2-sided 95% CI was >80%. Serum Ab levels were determined with radioimmunoassay (RIA).|Month 5 (1 month after V419 Dose 3)|All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.|||Percentage of Participants||95% Confidence Interval|Number
2663344|NCT01553279|Primary|Percentage of Participants With Anti-Meningococcal Serogroup C (Anti-MCC) Antibody (Ab) Titre ≥1:8 Dil One Month After MCC-TT or MCC-CRM (Part 1)|The acceptability (i.e., percentage of participants with anti-MCC Ab titre ≥1:8 dil) of the seroprotection rate (SPR) to MCC was determined 1 month after MCC-TT or MCC-CRM Dose 2. The SPR was considered acceptable if the lower bound of the 2-sided 95% CI was >90%. Serum Ab levels were assayed using the Meningo C rabbit complement serum bactericidal Ab (rSBA) assay.|Month 5 (1 month after MCC-TT/MCC-CRM Dose 2)|All randomized and treated participants with data available and who had no protocol violations that could interfere with results are included.|||Percentage of Participants||95% Confidence Interval|Number
2663347|NCT01553188|Other Pre-specified|Dose Limiting Toxicity (DLT)|DLTs are defined as any grade 3 or higher hematologic (excluding anemia) or non-hematologic toxicity considered to be possible related to AMG 386. Any treatment related adverse events that lead tor reduction of dose exposure of either agent (duration or dose) by >50% in cycle 1 will be considered a DLT.|First 28 days of treatment|Per protocol, only participants in the Run-in phase were evaluated for DLT.|||Participants|||Count of Participants
2663348|NCT01553188|Other Pre-specified|Maximum Tolerated Dose (MTD)|The MTD is defined as the highest dose studied for which the incidence of dose limiting toxicity was less than 33%.|First 28 days of treatment||||mg/kg|||Number
2663349|NCT01553188|Secondary|Count of Participants With Serious and Non-serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 65 months and 7 days||||Participants|||Count of Participants
2663350|NCT01553188|Secondary|Overall Survival|Overall Survival is the time between the first day of treatment to the day of death.|Time between the first day of treatment to the day of death, approximately 50.3 months.|One patient of the 9 (i.e., Run-in in Participant Flow) was not evaluable for responses as we previously defined through the document. Thus, it cannot be included in the PFS assessment. Patient came off the trial early for other reasons.|||Months||95% Confidence Interval|Median
2663351|NCT01553188|Secondary|Radiographic Progression Free Survival|Radiographic progression free survival is defined as the duration of time from start of treatment to time of radiographic progression by computed tomography (CT) scan (or magnetic resonance imaging (MRI)) or bone scan. Progression is a minimum of two new lesions observed on bone scan. The minimum size for a measurable lesion on CY and MRI should be twice the slice thickness based on the assumption that CT slice thickness is 500 or less.|Median potential follow-up of 50.3 months|One patient of the 9 (i.e., Run-in in Participant Flow) was not evaluable for responses as we previously defined through the document. Thus, it cannot be included in the PFS assessment. Patient came off the trial early for other reasons.|||Months||95% Confidence Interval|Median
2663352|NCT01553188|Primary|Progression Free Survival (PFS)|PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Clinical progression is assessed by the Response Criteria in Solid Tumors (RECIST) and is at least a 20% increase in the sum of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).|Median potential follow-up of 50.3 months|One patient of the 9 (i.e., Run-in in Participant Flow) was not evaluable for responses as we previously defined through the document. Thus, it cannot be included in the PFS assessment. Patient came off the trial early for other reasons.|||Months||95% Confidence Interval|Median
2663353|NCT01553136|Secondary|Drinking Related Consequences|A self-report measure of negative consequences from drinking will be administered and the total score are analyzed. The ImBIBe, a measure of alcohol consequences based on the Drinker Inventory of Consequences (DRINC) was used. The DRINC total score has a range from 0-45, 45 being the highest score (or greatest number of negative consequences).|End of treatment (Week 17)||||units on a scale||Standard Error|Least Squares Mean
2663354|NCT01553136|Secondary|Smoking Abstinence|Smoking abstinence is defined by self-reported abstinence from smoking for the last four weeks of treatment (weeks 13-16) and a urine cotinine level less than 15ng/mL measured at week 17.|Weeks 13-16||||Participants|||Count of Participants
2663355|NCT01553136|Primary|Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment|The percentage of days of heavy drinking will be examined over the final 8 weeks of the study. A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol. Presented here is the average of the 8 weeks (reported as week 17 originally).|8 weeks||||percentage of heavy drinking days||Standard Error|Least Squares Mean
2663356|NCT01553136|Primary|Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment|The percentage of days of heavy drinking will be examined over the final 8 weeks of the study averaged by month (weeks 9-12 and weeks 13-16). A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.|weeks 13-16||||log transformed percentage of days||Standard Error|Mean
2663357|NCT01553136|Primary|Percentage of Heavy Drinking Days During the Last 8 Weeks of Treatment|The percentage of days of heavy drinking will be examined over the final 8 weeks of the study averaged by month (weeks 9-12 and weeks 13-16). A heavy drinking day is defined as 5 or more standard drinks for men and 4 or more standard drinks for women. A standard drink contains approximately 0.6 fluid ounces of pure alcohol.|weeks 9-12||||log transformed percentage of days||Standard Error|Mean
2663358|NCT01553084|Secondary|The Effects of Quitting Smoking vs. Continued Smoking on Change in Carotid Intima-media Thickness (CIMT).|Change in carotid intima-media thickness (CIMT) from Baseline to Year 3 as a function of smoking status (abstinent versus smoking) at Year 3. Change is calculated as Baseline CIMT score minus Year 3 CIMT score. CIMT score is thickness of the carotid intima-media in millimeters (mm). Lower CIMT values indicate a better outcome.|Assessed at Baseline and Year 3|Includes only participants who completed both Baseline and Year 3 CIMT measurements.|||millimeters (mm)||Standard Deviation|Mean
2663359|NCT01553084|Secondary|Number of Participants With Initial Cessation in the First 7 Days Post-quit|Defined as at least 1 day of abstinence during the first 7 days after the target quit day.|Assessed for the first seven days after the target quit date.||||Participants|||Count of Participants
2663360|NCT01553084|Secondary|Number of Days to Relapse|The number of days to relapse is defined as the number of days from the target quit day until the first of seven consecutive days of smoking.|Assessed from the target quit day through 26 weeks.|Participants who did not relapse were censored in the survival analysis.|||Days||Standard Deviation|Mean
2663361|NCT01553084|Primary|Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks|Self-reported total abstinence from any tobacco use (even a single puff) for the seven days preceding the target follow-up day, confirmed with an exhaled carbon monoxide reading of <10 ppm..|Assessed 26 weeks after the target quit day.||||Participants|||Count of Participants
2663362|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: GlycA|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on GlycA|Baseline - Week 12||||log(pg/mL)||Standard Deviation|Mean
2663363|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: Log Interleukin 6|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log interleukin 6.|Baseline - Week 12||||log(pg/mL)||Standard Deviation|Mean
2663364|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: Log Tumor Necrosis Factor-alpha|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log Tumor necrosis factor-alpha.|Baseline - Week 12||||log(pg/mL)||Standard Deviation|Mean
2663365|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: Log C-reactive Protein|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log C-reactive protein (CRP).|Baseline - Week 12||||log(pg/mL)||Standard Deviation|Mean
2663366|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: Log Leptin|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log leptin.|Baseline - Week 12||||log(pg/mL)||Standard Deviation|Mean
2663367|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: Log Adiponectin|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log adiponectin.|Baseline - Week 12||||log(ug/mL)||Standard Deviation|Mean
2663368|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: Log Insulin|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on log insulin.|Baseline - Week 12||||log(pg/mL)||Standard Deviation|Mean
2663369|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: High Density Lipoprotein Particle Total|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on high density lipoprotein particle total.|Baseline - Week 12||||umol/L||Standard Deviation|Mean
2663370|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: Low Density Lipoprotein Particle Total|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on low density lipoprotein particle total.|Baseline - Week 12||||nmol/L||Standard Deviation|Mean
2663371|NCT01553058|Primary|Change in Cardiometabolic Biomarkers: Cholesterol Efflux|To assess the effects of adalimumab, as compared to NB-UVB phototherapy or placebo, in patients with moderate to severe psoriasis on cholesterol efflux capacity. The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: [(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)]. The pooled plasma was obtained from five healthy volunteers.|Baseline - Week 12||||unitless||Standard Deviation|Mean
2663372|NCT01553058|Secondary|Number of Patients With Adverse Events.|Safety will be assessed by comparing how many patients have adverse events depending on whether they are on adalimumab, as compared to NB-UVB phototherapy or placebo.|Baseline - Week 12||||Participants|||Count of Participants
2663373|NCT01553058|Secondary|Change in Patient-reported Outcomes-International Physical Activity Questionnaire (IPAQ)|Patient reported physical activity will be assessed using IPAQ. IPAQ is an instrument designed primarily for population surveillance of physical activity among adults with activity measured in metabolic equivalent (MET)-minutes per week.|Baseline week 4, 8 and 12||||MET-minutes/week||Standard Deviation|Mean
2663374|NCT01553058|Secondary|Change in Patient-reported Outcomes-MEDFICTS Dietary Assessment)|Patient reported dietary outcomes will be assessed using MEDFICTS (Meats, Eggs, Dairy, Fried foods, fat In baked goods, Convenience foods, fats added at the Table, and Snacks), a brief dietary assessment instrument for properly assessing cardiovascular diet. The questionnaire yields a continuous score (ranging from 0 to 216), with a score of <40 indicating adherence to the Therapeutic Lifestyle Changes (TLC) diet (intake of <7% of energy from saturated fat, <30% of energy from total fat, and <200 mg dietary cholesterol/day).|Baseline to Week 12||||units on a scale||Standard Deviation|Mean
2663375|NCT01553058|Secondary|Change in Patient-reported Outcomes-Dermatology Life Quality Index (DLQI)|Patient reported quality of life outcomes will be assessed using DLQI. The DLQI is calculated by summing the score of 10 questions regarding impact of skin condition on daily life resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.|Baseline - Week 12||||units on a scale||Standard Deviation|Mean
2663376|NCT01553058|Secondary|Change in Patient-reported Outcomes-EuroQol EQ-5D|EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a scale ranging from 1 (no health state problem) to 3 (extreme health state problems). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale ranging from 0, worst health state, to 100, best health state. A scoring function is used to assign a value (i.e., EQ-5D™ index score) to self-reported health states from a set of population-based preference weights. For the U.S. general population, the possible EQ-5D index scores range from -0.11 to 1.0 where 0.0 = death and 1.0 = perfect health.|Baseline -Week 12||||units on a scale||Standard Deviation|Mean
2663377|NCT01553058|Secondary|Change in Psoriasis Activity (PASI-75 and PGA)|Psoriasis activity will be assessed using standard psoriasis measurements, PASI75 and PGA Clear/Almost Clear|Baseline - Week 12||||Participants|||Count of Participants
2663379|NCT01553058|Primary|Change in Vascular Inflammation|Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between baseline and week 12. The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUV mean yielding a target to background ratio (TBR).|Baseline - Week 12||||Tissue-to-background ratio (TBR)||Standard Deviation|Mean
2663380|NCT01552954|Secondary|Systolic and Diastolic Blood Pressure Change Between Weeks 8 and 16|Change in Systolic and Diastolic Blood Pressure from Week 8 to Week 16 in the Intensive Education Group compared to the Conventional Education Group|week 8 and week 16||||mm Hg||Standard Deviation|Mean
2663381|NCT01552954|Secondary|Na Excretion Change in 24 Hour-urine Collection Between Weeks 8 and 16|Change of sodium excretion rate in 24 hour-urine collection by intensive education for low salt diet at week 16|week 8 and week 16||||mEq/day||Standard Deviation|Mean
2663382|NCT01552954|Secondary|∆Hemoglobin (0 Week - 16 Weeks)|The change of hemoglobin after prescription of Olmesartan|0 week, 16 weeks||||g/dL||Standard Deviation|Mean
2663383|NCT01552954|Primary|∆Albuminuria by 24-hour Urine Protein Excretion|"Change in albuminuria as a 24-hour urine protein excretion by intensive education of low salt diet during taking olmesartan~*In outcome measure data table, the 24-hour urine collection at 16th week was omitted in 3 out of 245 patients (1 for intensive education group and 2 for conventional education group). Values of each study week were mean of all participants on specific study week, but ∆albuminuria (week 8 - week 16) value was mean of ∆ values of 8 weeks-16 weeks in each individuals. Therefore, values of 3 patients were excluded in mean of ∆albuminuria (week 8 - week 16). That's why simple subtraction (week 8 - week 16) of values are not matched with the data."|changes from week 8 at week 16 (week 8 - week 16)||||mg/day||Standard Deviation|Mean
2663384|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in QT Intervals From Time-Matched Analysis by Largest Time Point|"The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.~The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points."|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||90% Confidence Interval|Least Squares Mean
2663385|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals From Time-Matched Analysis by Largest Time Point|"QT interval corrected for heart rate using Bazett's method (QTcB) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.~The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points."|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||90% Confidence Interval|Least Squares Mean
2663386|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals From Time-Matched Analysis by Largest Time Point|"QT interval corrected for heart rate using Fridericia's method (QTcF) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.~The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points."|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||90% Confidence Interval|Least Squares Mean
2663387|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in Heart Rate From Time-Matched Analysis by Largest Time Point|The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||beats per minute||90% Confidence Interval|Least Squares Mean
2663388|NCT01552928|Primary|Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals From Time-Matched Analysis by Largest Time Point|"QT interval corrected for heart rate using the subject-specific method (QTcNi) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.~The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points."|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||90% Confidence Interval|Least Squares Mean
2663389|NCT01552928|Secondary|Maximum Plasma Concentration (Cmax) of Metabolite of 2.5 mg Anagrelide (BCH24426) in Males and Females||Over 12 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.|||ng/ml||Standard Deviation|Geometric Mean
2663390|NCT01552928|Secondary|Maximum Plasma Concentration (Cmax) of Metabolite of 0.5 mg Anagrelide (BCH24426) in Males and Females||Over 12 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.|||ng/ml||Standard Deviation|Geometric Mean
2663391|NCT01552928|Secondary|Maximum Plasma Concentration (Cmax) of 2.5 mg Anagrelide in Males and Females||Over 12 hours post-dose|Pharmacokinetic Analysis Set consists of all subjects in the Safety Analysis Set who had evaluable concentration-time profiles for anagrelide, BCH24426, or moxifloxacin.|||ng/ml||Standard Deviation|Geometric Mean
2663393|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in QT Intervals at Subject-Specific Tmax|The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||90% Confidence Interval|Least Squares Mean
2663394|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in QTcB Intervals at Subject-Specific Tmax|QT interval corrected for heart rate using Bazett's method (QTcB) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||90% Confidence Interval|Least Squares Mean
2663395|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in QTcF Intervals at Subject-Specific Tmax|QT interval corrected for heart rate using Fridericia's method (QTcF) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||90% Confidence Interval|Least Squares Mean
2663396|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in Heart Rate at Subject-Specific Tmax||Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||beats per minute||90% Confidence Interval|Least Squares Mean
2663397|NCT01552928|Secondary|Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals at Subject-Specific Time of Maximum Plasma Concentration (Tmax)|QT interval corrected for heart rate using the subject-specific method (QTcNi) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value.|Over 12 hours post-dose|Full Analysis Set (FAS) consists of subjects in the Safety Analysis Set who had at least 1 electrocardiogram (ECG). Safety Analysis Set consists of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||90% Confidence Interval|Least Squares Mean
2663398|NCT01552915|Secondary|Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment||Baseline and up to 8 weeks|Safety Set: All randomized subjects who took at least 1 dose of investigational product.|||bpm||Standard Deviation|Mean
2663399|NCT01552915|Secondary|Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment||Baseline and up to 8 weeks|Safety Set: All randomized subjects who took at least 1 dose of investigational product.|||mmHg||Standard Deviation|Mean
2663400|NCT01552915|Secondary|Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment||Baseline and up to 8 Weeks|Safety Set: All randomized subjects who took at least 1 dose of investigational product.|||mmHg||Standard Deviation|Mean
2663401|NCT01552915|Secondary|Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Week 8|Full Analysis Set: All subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline primary efficacy assessment.|||percentage of participants|||Number
2663402|NCT01552915|Primary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8|The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Higher score indicates more severe symptoms.|Baseline and week 8|Full Analysis Set: All subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline primary efficacy assessment.|||units on a scale||Standard Error|Least Squares Mean
2663403|NCT01552902|Other Pre-specified|Change From Baseline in Pulse Rate at Week 6||Baseline, Week 6|Safety set. Not all Safety set participants were evaluable for this outcome measure.|||Beats per minute||Standard Deviation|Mean
2663404|NCT01552902|Other Pre-specified|Change From Baseline in Blood Pressure at Week 6||Baseline, Week 6|Safety set. Not all Safety set participants were evaluable for this outcome measure.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2663405|NCT01552902|Other Pre-specified|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered as a pharmaceutical product that did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events between first dose of double-blind investigational product and up to 3 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to 3 days after last dose (last dose at Week 6)|Safety set.|||participants|||Number
2663406|NCT01552902|Secondary|Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6|The Clinical Global Impressions Scale permits a global evaluation of the participant's severity of illness and improvement over time. The scale included a severity of illness item and a global improvement item. The investigator performed the CGI-I to rate the improvement of a participant's ADHD symptoms based on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse.). Percentage of participants with an improved measurement (response of very much improved and much improved) is reported.|Week 6|FAS.|||percentage of participants|||Number
2663407|NCT01552902|Primary|Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6|The ADHD-RS-IV was developed to measure the behaviors of children with ADHD and is commonly used in clinical studies of ADHD. The ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, Higher score = more severe symptoms.|Baseline, Week 6|Full Analysis Set (FAS) was defined as all participants in the Safety set who had at least 1 post-baseline measurement of the ADHD-RS-IV. Not all FAS participants were evaluable for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2663408|NCT01552889|Secondary|PROMIS Physical Functioning Scale 10a Short Form|This is a 10 item questionnaire that assesses the respondent's ability to perform common physical activities as rated on a 1-5 scale. The total score is converted to a T score which expresses where the individual ranks relative to the reference group.|12 months||||units on a scale||Standard Deviation|Mean
2663409|NCT01552889|Secondary|Treatment Satisfaction Scale.|This one item scale asks patients to rate their satisfaction with their depression treatment on a one (very dissatisfied) to 5 (very satisfied) scale.|12 months||||units on a scale||Standard Deviation|Mean
2663410|NCT01552889|Primary|Beck Depression Inventory 2|Self report depression symptom inventory. Scale ranges from 0-63. The higher the score the more depression symptoms. A score of 12 or greater is considered to indicate a clinically significant depression.|12 months||||units on a scale||Standard Deviation|Mean
2663411|NCT01552876|Other Pre-specified|Phase II: Absolute Rotation|Absolute rotation of the lens (degrees) at 1-minute post-fit on both eyes. Filcon II 3 lens was only used for comparison in phase II of the study per study protocol.|1-minute during Phase II|Analysis was on those subjects who were enrolled, randomized, and completed the study.|||Degrees|eyes|Standard Deviation|Mean
2663412|NCT01552876|Primary|Phase I: Absolute Lens Rotation|Lens orientation position as assessed on a scale of 0-180 on both eyes.|3 min after lens insertion during Phase I|Analysis was on those subjects who were enrolled, randomized, and completed the study.|||Degrees|eyes|95% Confidence Interval|Least Squares Mean
2663413|NCT01552876|Secondary|Phase I: Number of Blinks Until Settled|Number of blinks for the right eye was counted until lens settling using headcam video.|Baseline to 5 minutes during Phase I|Subjects analyzed are those who were enrolled, randomized, and completed the study.|||Blinks||Standard Error|Least Squares Mean
2663414|NCT01552876|Secondary|Phase I: Time to Lens Settling|With random insertion and natural blinking, the slit lamp video was used to measure the time of lens settling.|5 minutes after lens insertion during Phase I|Subjects analyzed were those who were enrolled, randomized, and completed the study.|||minutes||95% Confidence Interval|Least Squares Mean
2663415|NCT01552876|Primary|Phase I: Absolute Lens Rotation|At 1-min after lens insertion, lens orientation position was assessed on a scale of 0-180 degree on both eyes.|At 1-min after lens insertion during Phase I|Subjects included in the analysis were those who were enrolled, randomized, and completed the study.|||Degrees|eyes|95% Confidence Interval|Least Squares Mean
2663416|NCT01552772|Secondary|CGI-I Scale Score in LOCF Data.|The efficacy of trial medication were rated for each participant using the Clinical Global Impression Improvement (CGI-I) scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition a baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.|Week 1, 2 and 4|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.|||Units on a scale||Standard Deviation|Mean
2663417|NCT01552772|Secondary|Clinical Global Impression Improvement (CGI-I) Scale Score in OC Data.|The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition a baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.|Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).|||Units on a scale||Standard Deviation|Mean
2663418|NCT01552772|Secondary|Change From Baseline in CGI-S Score in LOCF Data.|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the rater or investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline, Week 1, 2 and 4.|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.|||Units on a scale||Standard Deviation|Mean
2663419|NCT01552772|Secondary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Score in OC Data.|"The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline, Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).|||Units on a scale||Standard Deviation|Mean
2663420|NCT01552772|Secondary|Change From Baseline in PANSS Negative Sub-scale Score for LOCF Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2 and 4|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.|||Units on a scale||Standard Deviation|Mean
2663421|NCT01552772|Secondary|Change From Baseline in PANSS Negative Sub-scale Score for OC Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).|||Units on a scale||Standard Deviation|Mean
2663422|NCT01552772|Secondary|Change From Baseline in PANSS Positive Sub-scale Score for LOCF Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2 and 4|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety EPS assessment scales.|||Units on a scale||Standard Deviation|Mean
2663423|NCT01552772|Secondary|Change From Baseline in PANSS Positive Sub-scale Score for OC Data.|The Positive and Negative Syndrome Scale (PANSS) consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).|||Units on a scale||Standard Deviation|Mean
2663424|NCT01552772|Secondary|Change From Baseline in Total Score of PANSS for Last Observation Carried Forward (LOCF) Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2 and 4|The efficacy analyses dataset consisted of enrolled participants who have at least one efficacy measurement. The LOCF method was used to impute missing data at visits after Baseline for the efficacy analysis and for the safety extrapyramidal symptoms (EPS) assessment scales.|||Units on a scale||Standard Deviation|Mean
2663425|NCT01552772|Secondary|Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) for Observed Cases (OC) Data.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Week 1, 2, 4 and Last visit (Day 28).|The efficacy analyses dataset consisted of enrolled participants who had at least one efficacy measurement. The OC dataset are participants who were evaluated at that visit on the efficacy variable under analysis (i.e. participants who had missing data due to drop out or other reasons were not included in the OC dataset).|||Units on a scale||Standard Deviation|Mean
2663426|NCT01552772|Primary|Number of Participants With Adverse Events (AE).|An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the study physician. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. TEAE stands for treatment emergent adverse events.|From the time the informed consent (ICF) was signed until follow-up at 30 days after the last trial visit (Day 28).|The safety analyses dataset consisted of data from all enrolled participants who received one dose of trial medication, regardless of any protocol deviation. All observed data for these participants were included.|||Participants|||Number
2663468|NCT01552369|Secondary|Major Fungal Infections|Opportunistic fungal infections|Up to 365 days post-transplant|ITT population|||Participants|||Count of Participants
2663469|NCT01552369|Secondary|Bacterial Infections|Incidence of bacterial opportunistic infections|Up to 365 days post-transplant||||Participants|||Count of Participants
2663427|NCT01552694|Secondary|Percent Change in Blood Endothelial Progenitor Cells|Monocytes (PBMC) are isolated from 20 mL blood. CD34+/VEGFR2+/KDR+ monocytes represent cell markers for endothelial progenitor cells (EPC). CD34+/VEGFR2+/KDR+ monocytes are counted (flow cytometry) and expressed as a percentage of PBMC number. Percent change between population averages from baseline to 2 months for the EPC/PBMC ratio is calculated and reported as the outcome measure.|Baseline to 2 months|CD34+/VEGFR2+/KDR+ monocytes (EPC) are a very rare cell type (<1% of PBMC). Not all blood samples contain EPC cells, or there are too few to count reliably. This measure was obtained in a subset of the total participants.|||Percent change|||Number
2663428|NCT01552694|Secondary|Fold Change in Adipose Inflammation Marker CCL2 (MCP-1) mRNA Expression|Adipose tissue from obese, insulin resistant subjects is characterized by increased macrophage infiltration and overexpression of inflammatory cytokines/chemokines. In adipose samples, mRNA expression for the macrophage inflammation marker CCL2 (MCP-1) was quantified. Fold change between population averages from baseline to 2 months for adipose macrophage CCL2 (MCP-1) mRNA expression is the outcome measure.|Baseline to 2 months|Adipose tissue samples were not available from all participants. This secondary outcome includes fewer participants analyzed than the primary outcome.|||fold change|||Number
2663429|NCT01552694|Primary|Inflammatory Biomarker 3: Serum D-dimer Concentration|There are 3 levels of the primary outcome measure, hsCRP, IL-6, and D-dimer|2 months||||µg FEU/mL||Standard Deviation|Mean
2663430|NCT01552694|Primary|Inflammatory Biomarker 2: Plasma IL-6 Concentration|There are 3 levels of the primary outcome measure; hsCRP, IL-6, and D-dimer concentrations measured at baseline and week 8|2 months||||pg/mL||Standard Deviation|Mean
2663431|NCT01552694|Primary|Inflammatory Biomarker 1: Plasma hsCRP Concentration|Fasting serum and plasma samples obtained at baseline and week 8 are batched for ELISA analysis (end of sudy) of hsCRP, IL-6 and D-dimer concentrations.|2 months||||mg/L||Standard Deviation|Mean
2663432|NCT01552681|Secondary|Percent of Participants With Injection Site Reaction or Any Grade 2 or Higher Adverse Event Within 24 Hours of Injection|Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0 over the duration of the study. Participants who experienced at least one injection site reaction or Grade 2 or higher adverse event within 24 hours of injection are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.|From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.|The Safety population included all randomized subjects who received at least one dose of either baminercept or placebo.|||Percent of participants|||Number
2663433|NCT01552681|Secondary|Percent of Participants With Grade 3 or Higher Infection Adverse Event|Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0 over the duration of the study. Participants who experienced at least one grade 3 or higher infection adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.|From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.|The Safety population included all randomized subjects who received at least one dose of either baminercept or placebo.|||Percent of participants|||Number
2663434|NCT01552681|Secondary|Percent of Participants With Adverse Events of Grade 3 or Higher|Grades are based on National Cancer Institute--Common Terminology Criteria (NCI-CTCAE) Version 4.0 over the duration of the study. Participants who experienced at least one grade 3 or higher adverse event (AE) are counted only once. The adverse events are treatment-emergent, which means that the AE occurred after taking the first dose of study drug.|From the time of administration of the first dose of study drug until the participant completed study participation, an average of 48 weeks.|The Safety population included all randomized subjects who received at least one dose of either baminercept or placebo.|||Percent of participants|||Number
2663435|NCT01552681|Secondary|Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 48|The SF-36 questionnaire completed by the subject measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Summary measures were standardized to have a mean of 50 and a standard deviation of 10 in the 1998 general US population. Change from baseline is computed as the value at Week 48 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had SF-36 data at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.|||units on a scale||Standard Deviation|Mean
2663436|NCT01552681|Secondary|Change From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Week 24|The SF-36 questionnaire completed by the subject measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Summary measures were standardized to have a mean of 50 and a standard deviation of 10 in the 1998 general US population. Change from baseline is computed as the value at Week 24 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had SF-36 data at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo.|||units on a scale||Standard Deviation|Mean
2663470|NCT01552369|Secondary|Late-onset CMV Disease|Incidence of late-onset CMV disease (occurring after 100 days post-randomization) as adjudicated by end point committee|Up to 365 days post-transplant|ITT population|||Participants|||Count of Participants
2663471|NCT01552369|Secondary|Graft Loss|Incidence of graft loss (re-transplantation)|Up to 365 days post-transplant|ITT population|||Participants|||Count of Participants
2663437|NCT01552681|Secondary|Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 48|Lissamine green stain was dropped into the participant's eyes and then an ophthalmologist used a slit lamp to examine the eye surface. Six areas of the eye surface were evaluated and scored from 0 to 3, with 0 being no tear film damage to 3, extensive tear film damage. The scores of all six areas in both eyes were totaled to obtain an overall score between 0 and 18. A higher score indicates insufficient tear flow and excessive dryness. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from Baseline indicates an improvement and a positive value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Lissamine Green Staining data at Baseline and Week 48. Data were not available for eight participants who received baminercept and one participant who received placebo.|||units on a scale||Standard Deviation|Mean
2663438|NCT01552681|Secondary|Change From Baseline in Tear Secretion as Measured by Lissamine Green Staining at Week 24|Lissamine green stain was dropped into the participant's eyes and then an ophthalmologist used a slit lamp to examine the eye surface. Six areas of the eye surface were evaluated and scored from 0 to 3, with 0 being no tear film damage to 3, extensive tear film damage. The scores of all six areas in both eyes were totaled to obtain an overall score between 0 and 18. A higher score indicates insufficient tear flow and excessive dryness. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from Baseline indicates an improvement and a positive value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Lissamine Green Staining data at Baseline and Week 24. Data were not available for six participants who received baminercept and three participants who received placebo.|||units on a scale||Standard Deviation|Mean
2663439|NCT01552681|Secondary|Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 48|A paper strip was placed within each lower eyelid and the participant's eyes were closed for 5 minutes. The wet paper was removed after 5 minutes and the length of wetting was recorded to the nearest 0.5 mm. Change from baseline was computed as the value at Week 48 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Schirmer's I test data at Baseline and Week 48. Data were not available for eight participants who received baminercept and one participant who received placebo.|||mm/5 min||Standard Deviation|Mean
2663440|NCT01552681|Secondary|Change From Baseline in Tear Secretion as Measured by Schirmer's I Test at Week 24|A paper strip was placed within each lower eyelid and the participant's eyes were closed for 5 minutes. The wet paper was removed after 5 minutes and the length of wetting was recorded to the nearest 0.5 mm. Change from baseline was computed as the value at Week 24 minus the baseline value. A positive value in change from Baseline indicates an improvement and a negative value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Schirmer's I test data at Baseline and Week 24. Data were not available for six participants who received baminercept and three participants who received placebo.|||mm/5 min||Standard Deviation|Mean
2663441|NCT01552681|Secondary|Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 48|A participant's overall rating of Disease Activity and a physician's rating of the participant's disease activity. A vertical mark made on a 100 mm line rated 0 (no symptoms) to 100 (severe symptoms) determines the score. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Patient and Physician Global assessments of Disease Activity at Baseline and Week 48. Data were not available for six participants|||mm||Standard Deviation|Mean
2663442|NCT01552681|Secondary|Change From Baseline in Patient and Physician Global Assessments of Disease Activity at Week 24|A participant's overall rating of Disease Activity and a physician's rating of the participant's disease activity. A vertical mark made on a 100 mm line rated 0 (no symptoms) to 100 (severe symptoms) determines the score. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had Patient and Physician Global assessments of Disease Activity at Baseline and Week 24. Data were not available for six participants|||mm||Standard Deviation|Mean
2663443|NCT01552681|Secondary|Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48|Three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 3 questions. The range is 0 to 100, with 100 as the highest perceived tiredness, dryness, or joint pain. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS scores at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.|||mm||Standard Deviation|Mean
2663444|NCT01552681|Secondary|Change From Baseline in Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24|Three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 3 questions. The range is 0 to 100, with 100 as the highest perceived tiredness, dryness, or joint pain. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS scores at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo.|||mm||Standard Deviation|Mean
2663445|NCT01552681|Secondary|Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 48|On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 14 questions about salivary and ophthalmic function. The range is 0 to 100, with 100 as the highest perceived difficulty, dryness, discomfort, swelling, thirst, dryness, severity, or sensitivity. Change from baseline was computed as the value at Week 48 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS scores at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.|||mm||Standard Deviation|Mean
2663446|NCT01552681|Secondary|Change From Baseline in Visual Analog Scale (VAS) Scores for Sjogren's Syndrome Symptom Survey at Week 24|On a 100-mm horizontal line the participant places a vertical mark to indicate responses to 14 questions about salivary and ophthalmic function. The range is 0 to 100, with 100 as the highest perceived difficulty, dryness, discomfort, swelling, thirst, dryness, severity, or sensitivity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS results at Baseline and Week 24. Data were not available for four participants who received baminercept and two participants who received placebo.|||mm||Standard Deviation|Mean
2663447|NCT01552681|Secondary|Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 48|Response is defined by 30% or more improvement (decrease) from baseline to week 48 in at least two of the three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate a response. The range is 0 to 100, with 100 as the highest perceived overall fatigue, overall dryness, or joint pain.|Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS results at Baseline and Week 48. Data were not available for five participants who received baminercept and one participant who received placebo.|||Percent of participants|||Number
2663448|NCT01552681|Secondary|Percent of Subjects Classified as Responders According to the Patient Self-Assessment of Fatigue, Overall Dryness, and Joint Pain at Week 24|Response is defined by 30% or more improvement (decrease) from baseline to week 24 in at least two of the three Visual Analog Scale (VAS) scores for patient self-assessment of symptoms of overall dryness, fatigue, and joint pain. On a 100-mm horizontal line the participant places a vertical mark to indicate a response. The range is 0 to 100, with 100 as the highest perceived overall fatigue, overall dryness, or joint pain.|Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had VAS results at Baseline and Week 24. Data were not available for four participants who received baminercept and one participant who received placebo.|||Percent of participants|||Number
2663449|NCT01552681|Secondary|Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 24|The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening.|Baseline to Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had an ESSDAI score at Baseline and Week 24. Data were not available for five participants who received baminercept and two participants who received placebo.|||units on a scale||Standard Deviation|Mean
2663450|NCT01552681|Secondary|Change From Screening in Unstimulated Whole Salivary Flow at Week 48|The participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the unstimulated salivary flow rate (mL/min). Cholinergic stimulants such as pilocarpine or cevimeline were discontinued for 48 hours prior to the assessment and nothing was taken by mouth for 60 minutes or longer before or during saliva collection. Change from screening was computed as the value at Week 48 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.|Screening to Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received at least one dose of either baminercept or placebo and who had unstimulated salivary flow results at Screening and Week 48. Data were not available for six participants who received baminercept and one participant who received placebo.|||mL/min||Standard Deviation|Mean
2663451|NCT01552681|Secondary|Change From Screening in Unstimulated Whole Salivary Flow at Week 24|The participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the unstimulated salivary flow rate (mL/min). Cholinergic stimulants such as pilocarpine or cevimeline were discontinued for 48 hours prior to the assessment and nothing was taken by mouth for 60 minutes or longer before or during saliva collection. Change from screening was computed as the value at Week 24 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.|Screening to Week 24|The Modified Intent-to-Treat with available data population included all randomized subjects who received >=1 dose of either baminercept or placebo and who had an unstimulated salivary flow assessment at screening and week 24. Data were not available for N=7 subjects (e.g., N=5 in baminercept and N=2 in placebo group).|||mL/min||Standard Deviation|Mean
2663472|NCT01552369|Secondary|Incidence of Allograft Rejection|Number of subjects with allograft rejection|Up to 365 days post-transplant||||Participants|||Count of Participants
2663452|NCT01552681|Secondary|Change From Screening in Stimulated Whole Salivary Flow at Week 48|After an unstimulated salivary flow assessment the participant was administered a single 5-mg dose of pilocarpine to stimulate saliva production. One hour after the administration of pilocarpine the participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the stimulated salivary flow rate (mL/min). Change from screening was computed as the value at Week 48 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.|Screening to Week 48|The Modified Intent-to-Treat with available data population included all randomized subjects who received >=1 dose of either baminercept or placebo and who had stimulated salivary flow results at screening and Week 48. Wk 48 stimulated salivary flow results were not available for N=7 subjects (e.g., N=6 in baminercept and N=1 in placebo group).|||mL/min||Standard Deviation|Mean
2663453|NCT01552681|Primary|Change From Screening in Stimulated Whole Salivary Flow at Week 24|After an unstimulated salivary flow assessment the participant was administered a single 5-mg dose of pilocarpine to stimulate saliva production. One hour after the administration of pilocarpine the participant spit into a preweighed 50-cm centrifuge tube for 15 minutes. The sample was weighed to determine the volume (1 g = 1 mL) of saliva. The volume of saliva (mL) was divided by the duration of the test (minutes) to calculate the stimulated salivary flow rate (mL/min). Change from screening was computed as the value at Week 24 minus the screening value. A positive value in change from screening indicates an improvement and a negative value indicates worsening.|Screening to Week 24|The Modified Intent-to-Treat population included all randomized subjects who received at least one dose of either baminercept or placebo with screening and post-screening stimulated salivary flow results. Participants missing Week 24 assessment were imputed from last post-screening assessment. Salivary flow results unavailable for one subject.|||mL/min||Standard Deviation|Mean
2663454|NCT01552603|Secondary|Mean Deviation From Target Blood Glucose|Mean difference of venous blood glucose from glucose target. Daytime venous blood glucose values (7am-11pm) subtracted from daytime target of 115 mg/dl. Nighttime venous blood glucose values (11pm-7am) subtracted from nighttime target of 140 mg/dl. This is a metric of how successful the closed loop algorithm was at controlling glucose.|all 28 hour studies||||mg/dl||Standard Deviation|Mean
2663455|NCT01552603|Primary|Mean Percent of Time in Target Blood Glucose Range|Mean percent of time venous blood glucose was sampled between 70-180 mg/dl|all 28 hour studies||||percentage of time||Standard Deviation|Mean
2663456|NCT01552408|Secondary|Mean Change in Peripheral Visual Field as Measured by Goldmann Visual Field at Screen and Month and 36.|Mean change in peripheral visual field as measured by Goldmann visual field at screen and Month 36 in the ranibizumab and targeted PRP with ranibizumab cohorts.|36 Months|Participants that had poor fix (resulting in inaccurate results), missing baseline results, or missing Month 36 results were excluded.|||degrees squared||Standard Deviation|Mean
2663457|NCT01552408|Secondary|Patients With Persistent Macular Edema Post-intravitreal Injection.|Percentage of patients with persistent macular edema post-intravitreal injection in the ranibizumab and targeted PRP with ranibizumab cohorts.|Month 36|All participants were included in analysis. Due to participant attrition and missed visits, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||Participants|||Count of Participants
2663458|NCT01552408|Secondary|Evaluate Mean Change in Central Retinal Thickness Over Time Through Month 12, 24, and 36 as Assessed by High Resolution OCT's.|Evaluate mean change in central retinal thickness in the ranibizumab and targeted PRP with ranibizumab cohorts over time through Month 12, 24, and 36 as assessed by high resolution OCT's.|Month 12, 24, and 36|All participants were included in analysis. Due to participant attrition and missed visits, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||microns||Standard Deviation|Mean
2663459|NCT01552408|Secondary|Determine Percentage of Patients Who Experience a Gain of 15 or More Letters From Baseline to Month 12, 24, and 36 in ETDRS BCVA|Determine percentage of patients who experience a gain of 15 or more letters from Baseline to Month 12, 24, and 36 in ETDRS BCVA in the ranibizumab and targeted PRP with ranibizumab cohorts.|Month 12, 24, and 36|All participants were included in analysis. Due to participant attrition and missed visits, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||Participants|||Count of Participants
2663460|NCT01552408|Secondary|Patients Who Experience a Loss of 15 or More Letters From Baseline to Month 12, 24, and 36 in ETDRS BCVA.|Percentage of patients in the ranibizumab and targeted PRP with ranibizumab cohorts who experience a loss of 15 or more letters from Baseline to Month 12, 24, and 36 in ETDRS BCVA.|Month 12, 24, and 36|All participants were included in analysis. Due to participant attrition and missed visits, the population analyzed at each time point is equal to or smaller than the population still enrolled at that time point.|||Participants|||Count of Participants
2663461|NCT01552408|Primary|Incidence and Severity of Ocular and Non-ocular Adverse Events (AE's) Through Month 36.|Incidence and severity of ocular and non-ocular adverse events (AE's) in the monotherapy and combination cohorts through Month 36.|36 Months||||Participants|||Count of Participants
2663462|NCT01552408|Primary|Mean Change Over Time in Early Treatment Diabetic Retinopathy Study Best Corrected Visual Acuity (ETDRS BCVA) Through Month 36|Evaluate the mean change over time in ETDRS BCVA in the ranibizumab and targeted PRP with ranibizumab cohorts through Month 36.|36 Months|All participants were included in analysis. Among participants who failed to complete the study, the last observation was carried forward for analysis at Month 36.|||letters||Standard Deviation|Mean
2663463|NCT01552408|Primary|Total Number of Ranibizumab Injections in Each of the Two Cohorts in a 36 Month Period|Assess the number of ranibizumab injections in the ranibizumab and targeted panretinal photocoagulation (PRP) with ranibizumab cohorts through Month 36.|36 Months|All participants were included in analysis. Among participants who failed to complete the study, the last observation was carried forward for analysis at Month 36.|||injections||Full Range|Mean
2663464|NCT01552369|Secondary|Hematopoietic Growth Factors|Hematopoietic growth factor receipt for ANC less than 500 during valganciclovir treatment.|Day 1 through Day 107||||Participants|||Count of Participants
2663465|NCT01552369|Secondary|Neutropenia Less Than 500|ANC less than 500 while on valganciclovir|prior to day 107|ITT population|||Participants|||Count of Participants
2663475|NCT01552343|Secondary|Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE was any adverse event occurring after start of treatment and within the time of residual drug effect, i.e. within one day of the last dose of desmopressin.|Day 1 up to 1 month|Safety analysis set|||participants|||Number
2663476|NCT01552343|Secondary|Minimum Post-Treatment Serum Sodium Levels|Serum sodium levels were monitored since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time.|Day 1 up to 1 month|Safety analysis set|||participants|||Number
2663477|NCT01552343|Secondary|Change From Baseline to Month 1 on Nocturia Impact (NI) Total Score|The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). Responses are scored from 0 (no impact) to 4 (highest impact); the NI total score is the sum of the 11 core items scores (range of 0-44) which is then transformed to a 0-100 scale (high score indicates high impact). The NI total score was analyzable only if all 11 items (Q1-Q11) had non-missing responses. Otherwise, it was defined as missing. Missing values were not imputed. The average over the 3-day diary period prior to baseline (Day 1) and Month 1 was used for the overall impact score. Negative change from baseline scores indicate a decrease in impact caused by nocturia.|Baseline (Day -2 to Day 1), Treatment (Day 28-30)|Full analysis set. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.|||units on a scale||Standard Deviation|Mean
2663478|NCT01552343|Secondary|Construct Validity For the Nocturia Impact (NI) Total Scores and Overall Impact Question (Q12) for Participants With High/Low Number of Nocturnal Voids|"The known group validity was assessed by comparing participants who experienced ≥3 nocturnal voids to those who experienced <3 nocturnal voids, using the average over 3 days for the Screening and Baseline diaries. Results are reported for the NI Total Scores and the Overall Impact Question (Q12).~The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). The NI total score is defined as the sum of the 11 core items scores.~The overall impact question (Q12) and the NI total score were transformed using Fisher's z transformation, i.e. the scores were based on a standardized scale from 0 (lowest impact) to 100 (highest impact)."|Screening (Day -20), Baseline (Day 1)|Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.|||units on a scale||Standard Deviation|Mean
2663479|NCT01552343|Secondary|Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values|"Cronbach's alpha (CA) is a measure of the internal consistency of the Nocturia Impact (NI) Total scores. Higher scores indicate a more reliable (precise) instrument. A value of 0.70 set as the benchmark for declaring the scale as internally consistent.~Cronbach's alpha was assessed for each of the three consecutive days NI diaries were completed during screening (Day -20 to Day -18), baseline (Day -2 to Day 1) and Month 1 (Day 28 to Day 30)."|Screening (Day -20 to Day -18), Baseline (Day -2 to Day 1) and Treatment (Day 28 to Day 30)|Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.|||ratio of variance||95% Confidence Interval|Number
2663480|NCT01552343|Primary|Cohen's D Effect Size in Responsiveness in the Nocturia Impact (NI) Total Scores and Overall Impact Question as Measured From Baseline (Day 1) to Month 1|"The responsiveness of the NI Diary was measured with Cohen's D effect size. The effect size was calculated for active treatment versus placebo, based on change from Baseline to Month 1. The effect size was evaluated as small, medium, or large if D was <=0.35, >0.35 - 0.65, or >0.65, respectively.~Mean values are the Cohen's D effect size. Standard deviation is the pooled standard deviation."|Day 1 (Baseline), Month 1|Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.|||units on a scale||Standard Deviation|Mean
2663481|NCT01552343|Primary|Difference in Mean Change From Baseline to Month 1 in Nocturia Impact (NI) Total Scores and Overall Impact Question for Responders and Non-Responders|"This outcome is a measure of sensitivity of the NI Diary to change in nocturia.~The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). The NI total score is defined as the sum of the 11 core items scores.~The overall impact question (Q12) and the NI total score were transformed using Fisher's z transformation, i.e. the scores were based on a standardized scale from 0 (lowest impact) to 100 (highest impact).~The difference in mean change in NI total score for subjects who experienced a reduction from baseline of <33% in nocturnal voids at the Month 1 visit (non-responders) versus those with a reduction in nocturnal voids from Baseline of ≥33% (responders) was estimated."|Day 1 (Baseline), Month 1|Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.|||units on a scale||Standard Deviation|Mean
2663482|NCT01552343|Primary|The Pearson Correlation Coefficient Between Change From Baseline to Month 1 in Number of Nocturnal Voids and Change From Baseline to Month 1 in Nocturia Impact (NI) Diary Total Score|"This outcome is a measure of sensitivity of the NI Diary to change in nocturia.~The NI Diary is a 12-item instrument consisting of 11 core items and an overall impact question (Q12). Responses are scored from 0 (no impact) to 4 (highest impact); a lowering of score equals a decrease in impact caused by nocturia. The NI total score is the sum of the 11 core items scores. The NI total score was analyzable only if all 11 items (Q1-Q11) had non-missing responses. Otherwise, it was defined as missing. Missing values were not imputed. The average over the 3-day diary period prior to baseline (Day 1) and Month 1 was used for the overall impact score.~The correlation was estimated using Fisher's z transformation, i.e. the NI total score was based on a standardized scale from 0 (lowest impact) to 100 (highest impact).~Corresponding adjusted partial correlation coefficients were based on adjustments for mean number of Baseline voids, Baseline NI total score, age, and gender."|Day 1 (Baseline), Month 1|Full analysis set. Study results are reported as per the pre-planned statistical analysis plan on combined treatment groups. The study is a psychometric evaluation of a new PRO tool and is not designed to show treatment difference between active and placebo.|||correlation coefficient||95% Confidence Interval|Number
2663486|NCT01552213|Secondary|Mean Level of Umbilical Cord C-peptide >=90th Percentile in the Whole Cohort|C-peptide test is a tool for monitoring and treating diabetes.|Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation|Participants with available data included in the analysis.|||Participants|||Count of Participants
2663487|NCT01552213|Secondary|Mean Ponderal Index|The Corpulence Index (CI) or Ponderal Index (PI) is a measure of leanness (corpulence) of a person calculated as a relationship between mass and height.|Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation|Participants with available data included in the analysis.|||kg/m3||Standard Deviation|Mean
2663488|NCT01552213|Secondary|Mean Neonatal Birth Weight||Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation|Participants with available data included in the analysis.|||grams||Standard Deviation|Mean
2663489|NCT01552213|Secondary|Number of Participants With Need for Insulin Therapy|Insulin required during pregnancy|Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation|Participants with available data included in the analysis.|||Participants|||Count of Participants
2663490|NCT01552213|Secondary|Mean Level of Postpartum Oral Glucose-tolerance-test at 6 Weeks Postpartum||6 weeks after delivery|Participants with available data included in the analysis.|||mg/dL||Standard Deviation|Mean
2663491|NCT01552213|Secondary|Number of Patients With Pre-eclampsia|Blood pressure greater than or equal to 140/90 with 300 mg of protein on a 24-hour urine collection.|Up to 6 weeks after delivery|Participants with available data included in the analysis.|||Participants|||Count of Participants
2663492|NCT01552213|Secondary|Number of Patients With Gestational Hypertension|Hypertensive disorder in pregnancy with blood pressure greater than or equal to 140/90 after 20 weeks gestation|Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation|Participants with available data included in the analysis.|||Participants|||Count of Participants
2663493|NCT01552213|Secondary|Mean Fasting Triglyceride Level||Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation|Participants with available data included in the analysis.|||mg/dL||Standard Deviation|Mean
2663494|NCT01552213|Secondary|Mean Hemoglobin A1C Value at Delivery||Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation|Participants with available data included in the analysis.|||percent||Standard Deviation|Mean
2663495|NCT01552213|Secondary|Number of Participants With Excessive Gestational Weight Gain|Excessive weight gain greater than the Institute of Medicine guidelines|Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation|Participants with available data included in the analysis.|||Participants|||Count of Participants
2663496|NCT01552213|Secondary|Number of Participants With Different Modes of Delivery|Modes of delivery investigated were: cesarean delivery, vaginal delivery, assisted vaginal delivery, spontaneous delivery and termination of pregnancy.|Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestation|Participants with available data included in the analysis.|||Participants|||Count of Participants
2663497|NCT01552213|Primary|Number of Patients With a Diagnosis of Gestational Diabetes at 26 Weeks Gestation.|Diagnosis based on criteria recommended by the ADA (Oral GTT with one abnormal value, fasting greater than or equal to 92, on hour greater than or equal to 180, two hour greater than or equal to 153)|26 weeks of gestation||||Participants|||Count of Participants
2663498|NCT01552057|Primary|Change From Baseline up to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (ANCOVA)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an analysis of covariance (ANCOVA) approach including administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates.|Baseline, up to 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity); Last Observation Carried Forward (LOCF) values were used.|||units on a scale||Standard Error|Least Squares Mean
2663499|NCT01552057|Primary|Change From Baseline to 10 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 10 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
2663500|NCT01552057|Primary|Change From Baseline to 6 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 6 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
2663501|NCT01552057|Primary|Change From Baseline to 4 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 4 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
2663502|NCT01552057|Primary|Change From Baseline to 2 Weeks in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 2 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
2663503|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Brief Pain Inventory-Severity (BPI-S) and Brief Pain Inventory-Interference (BPI-I) Scores on the BPI-Modified Short Form|BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function, respectively. Severity scores ranged from 0 (no pain) to 10 (severe pain) for each question assessing worst pain, least pain, and pain right now. Interference scores ranged from 0 (does not interfere) to 10 (completely interferes) for each question assessing interference of pain in past 24 hours with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference was the average of non-missing scores of individual interference items. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
2663504|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Average Pain and Worst Pain Severity Score Within 24-Hours in Participant Diary|Each morning participants rated their average pain and worst pain within the past 24 hours on separate 11-point Likert scales with scores ranging from 0 (no pain) through 10 (worst possible pain). These scores were then averaged for the week and compared to baseline. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
2663505|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Widespread Pain Index (WPI) and Symptom Severity (SS) in American College of Rheumatology (ACR) Fibromyalgia Diagnostic Criteria 2010|WPI: Participant-reported areas (out of 19 points on the body) in which the participant had pain in the past week. WPI scores ranged from 0 (no areas) to 19 (all areas). SS: The sum of severity scores for fatigue, waking unrefreshed, and cognitive symptoms [each rated from 0 (no problem) to 3 (severe; life-disturbing problems)] plus the severity of somatic symptoms in general [rated from 0 (no symptoms) to 3 (a great deal of symptoms)]. The total SS score ranged from 0 and 12. LS mean was calculated using an MMRM approach including administration groups, observation points, interaction between the administration groups and the observation points as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
2663506|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Beck Depression Inventory-II (BDI-II)|The BDI-II is a 21-item self-administered questionnaire designed to assess the characteristics of depression. Each item was scored on a 4-point scale ranging from 0 (not present) to 3 (present in the extreme) and was summed to give a total BDI-II score. A total BDI-II score of 0 through 13 was considered minimal, 14 through 19 was mild, 20 through 28 was moderate, and 29 through 63 was severe depression symptoms. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups and as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
2663507|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in 36-Item Short-Form (SF-36) Health Survey Domain Scores|The SF-36 Health Survey is a generic, health-related survey assessing the participant's quality of life on 8 domains: physical functioning, daily functioning (physical), bodily pain, general health, vitality, social functioning, daily functioning (emotional), and mental health. Each domain was scored by summing individual items pertaining to that domain and transforming scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. LS mean was calculated using an ANCOVA approach including administration groups as fixed effects, and baseline as well as the presence or absence of complication by major depressive disorder as covariates.|Baseline, up to 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity); LOCF values were used.|||units on a scale||Standard Error|Least Squares Mean
2663515|NCT01551979|Primary|Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) General Subscale|Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) General Subscale, a 16 item subscale measuring the presence/absence and severity of general psychopathology of schizophrenia. The minimum score is 16 and the maximum score is 112, with higher values representing greater psychopathology severity. Change from baseline on the PANSS General Subscale can range from -96 to +96; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.|Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment|Participant drop out|||units on a scale||Standard Deviation|Mean
2663508|NCT01552057|Secondary|Change From Baseline to 14-Week Endpoint in Fibromyalgia Impact Questionnaire (FIQ)|FIQ is a 20-item, self-administered questionnaire using Likert-type scales to measure participant (pt) outcomes over the past week. Items 1 through 11 measured physical functioning on 4-point scales. Items 12 and 13 measured the number of days a pt felt well and days a pt was unable to work due to fibromyalgia symptoms. Items 14 through 20 were 11-point scales on which a pt rated work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. If a pt did not do all the tasks listed, those items were deleted from scoring. Algorithms were used to determine total FIQ scores which ranged from 0 to 100; higher scores indicated a more negative impact. LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between administration groups as fixed effects, and baseline as well as the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
2663509|NCT01552057|Secondary|Clinical Global Impression of Improvement (CGI-I) at Endpoint|CGI-I measures the clinician's perception of participant improvement at the time of assessment (compared with the start of treatment). Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
2663510|NCT01552057|Secondary|Patients Global Impression of Improvement (PGI-I) at Endpoint|PGI-I measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores ranged from 1 (very much better) to 7 (very much worse). LS mean was calculated using an MMRM approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
2663511|NCT01552057|Primary|Change From Baseline to 14-Week Endpoint in the BPI 24-Hour Average Pain Severity Item of the BPI-Modified Short Form Score (MMRM)|BPI 24-hour average pain severity is a self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. Severity scores ranged from 0 (no pain) to 10 (severe pain). Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including administration groups, observation points, and interaction between the administration groups as fixed effects, and BPI average pain severity at baseline and the presence or absence of major depressive disorder as covariates; a linear model with unstructured error variance was applied.|Baseline, 14 weeks|Randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline measurement of primary efficacy (BPI 24-hour average pain severity).|||units on a scale||Standard Error|Least Squares Mean
2663512|NCT01551979|Secondary|Change From Baseline on the Calgary Depression Scale for Schizophrenia|The Calgary Depression Scale for Schizophrenia is a 9-item scale that assesses depressive symptoms in patients with schizophrenia. Each item is rated separately and ratings range from 0 to 3. Higher values represent more severe depressive symptoms: 0 indicates an absent symptom and 3 indicates a severe symptom. The overall Calgary Depression Scale score is computed by summing each item. The total Calgary Depression Scale score ranges from 0 to 27, with higher values representing more severe depression in patients with schizophrenia. Change from baseline on the Calgary Depression Scale can range from -27 to +27, with negative values representing an improvement in depressive symptoms and positive values representing worsening depressive symptom severity. Depression was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.|Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment|Participant drop out|||units on a scale||Standard Deviation|Mean
2663513|NCT01551979|Primary|Clinical Global Impression (CGI) Global Improvement|Treatment response was evaluated with the Clinical Global Impressions (CGI) Scale, which is comprised of two companion one-item measures that use 7-point scales to evaluate severity of psychopathology and improvement from the initiation of treatment; each component is rated separately and the CGI does not yield a global score. The CGI Global Improvement is a 7-point subscale in which a clinician assesses how much a patient's illness has changed compared to baseline. Ratings range from 1 to 7, with 1 indicating very much improved and 7 indicating very much worse. Change from baseline on the CGI Global Improvement subscale can range from -6 to +6, with negative values representing an improvement in psychopathology and positive values representing worsening psychopathology. Global Improvement was assessed after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.|Last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment|Participant drop out|||units on a scale||Standard Deviation|Mean
2663514|NCT01551979|Primary|Change From Baseline on the Clinical Global Impression (CGI) Severity of Illness|Treatment response was evaluated with the Clinical Global Impressions (CGI) Scale, which is comprised of two companion one-item measures that use 7-point scales to evaluate severity of psychopathology and improvement from the initiation of treatment; each component is rated separately and the CGI does not yield a global score. The CGI Severity of Illness is a 7-point subscale in which a clinician rates the severity of the patient's illness at the time of assessment. Ratings range from 1 to 7 and higher values represent more severe psychopathology: 1 indicates a normal and not at all ill patient and 7 indicates among the most extremely ill patients. Change from baseline on the CGI Severity of Illness subscale can range from -6 to +6, with negative values representing an improvement in psychopathology and positive values representing worsening psychopathology. Severity of Illness was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.|Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment|Participant drop out|||units on a scale||Standard Deviation|Mean
2663567|NCT01551212|Secondary|Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death|Percentage of Participants with Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death at Month 12|12 months|FAS|||Percent of Patients|||Number
2663516|NCT01551979|Primary|Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Negative Subscale|Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Negative Subscale, a 7 item subscale measuring the presence/absence and severity of negative symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Change from baseline on the PANSS Negative Subscale can range from -42 to +42; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.|Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment|Participant drop out|||units on a scale||Standard Deviation|Mean
2663517|NCT01551979|Primary|Change From Baseline on the Positive and Negative Syndrome Scale (PANSS) Positive Subscale|Therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Positive Subscale, a 7 item subscale measuring the presence/absence and severity of positive symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Change from baseline on the PANSS Positive Subscale can range from -42 to +42; negative values represent an improvement in symptom severity, and positive values represent worsening symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, 1 week post treatment, and 3 weeks post treatment.|Before treatment (baseline), last day of treatment (after 5 days of treatment), 1 and 3 weeks post treatment|Participant drop out|||units on a scale||Standard Deviation|Mean
2663518|NCT01551888|Primary|Maximum Formoterol Plasma Drug Concentration (Cmax) Following a Single Dose|The standard deviation of the measure is expressed as the coefficient of variation (%)|Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose|The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters|||pg/mL||Standard Deviation|Mean
2663519|NCT01551888|Secondary|Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval Following a Single Dose|The standard deviation of the measure is expressed as the coefficient of variation (%)|Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose|The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters|||pg*hr/mL||Standard Deviation|Mean
2663520|NCT01551888|Primary|Maximum Formoterol Plasma Drug Concentration (Cmax) at Steady State|The standard deviation of the measure is expressed as the coefficient of variation (%)|Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose; Days 2-4: 0, 5 and 15 min post dose; Day 5: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (post AM dose)|The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters|||pg/mL||Standard Deviation|Mean
2663521|NCT01551888|Primary|Area Under the Formoterol Plasma Concentration Versus Time Curve (AUC) Over Dosing Interval at Steady State|The standard deviation of the measure is expressed as the coefficient of variation (%)|Day 1: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (5 min before PM dose) and 5 and 15 min post PM dose; Days 2-4: 0, 5 and 15 min post dose; Day 5: 0, 5, 15 and 30 min and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours (post AM dose)|The pharmacokinetic (PK) analysis population included all patients who completed the study and had evaluable PK parameters|||pg*hr/mL||Standard Deviation|Mean
2663522|NCT01551758|Secondary|Number of Participants With Serious Adverse Drug Reactions|A serious adverse drug reactions (SADR) is any untoward medical occurrence suspected to be medicinal product-related that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.|Upto 12 months|ITT Population|||Participants|||Number
2663523|NCT01551758|Secondary|Number of Participants With Serious Adverse Events|SAEs assessed included medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a significant medical event in the investigator's judgment, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. SAEs were includes if the onset date was on or after the treatment start date and on or before the treatment stop date. However, the window for an SAE of pneumonia was longer and included 28 days post study treatment stop date.|Up to 56 weeks|ITT Population|||Participants|||Number
2663524|NCT01551758|Secondary|Number of Participants With Non-serious Adverse Drug Reactions (ADR)|The number of participants with non-serious ADRs was assessed for up to 54 weeks. An ADR is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, for which there is a reasonable possibility that the untoward occurrence is causally related to the medicinal product. A non-serious ADR included one of the following: exacerbation of chronic or intermittent pre-existing condition; signs, symptoms, or the clinical sequelae of a suspected interaction; signs, symptoms, or new conditions detected or diagnosed after study treatment administration.|Up to 54 weeks|ITT Population|||Participants|||Number
2663525|NCT01551758|Secondary|Number of Participants With Fatal Serious Adverse Events of Pneumonia|"All SAEs included in the AE subgroup of special interest of pneumonia were considered as an SAE of pneumonias. A fatal SAE was defined as a SAE with outcome of fatal for study participant. The number of participants with fatal SAEs of pneumonia was assessed over 14 months."|Upto 58 weeks|ITT Population|||Participants|||Number
2663526|NCT01551758|Secondary|Time to First Severe Exacerbations Occurring in a Year|"The date of an event for severe exacerbation was defined as the exacerbation onset date. Participants who completed the study without a severe exacerbation were censored. The analysis method was a Cox proportional hazards model adjusted for randomized treatment.~The probability of first severe exacerbation was measured from the date of randomisation (i.e., treatment initiation) to the onset date of first severe exacerbation, as recorded on eCRF, or date of treatment termination (Visit 6 or early withdrawal visit) for participants who completed the study without any severe exacerbations (censored). At Day 364, all participants who have not experienced a severe exacerbation are considered censored, regardless of whether their on-treatment phase continues beyond day 364, including those who withdrew early. Number of participants with event is presented."|Up to 364 days|ITT Population|||Participants|||Number
2663527|NCT01551758|Secondary|Time to First Moderate/Severe Exacerbations on Initial Therapy Occurring in a Year|The date of an event for moderate / severe COPD exacerbation was defined as the exacerbation onset date. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. The probability of first moderate / severe exacerbation on initial therapy was measured from the date of randomisation (i.e., exposure start date) to the onset date of first moderate or severe COPD exacerbation, or to the date of discontinuation of initial therapy (analysis was censored at date of discontinuation of initial therapy) for participants who completed the study without any moderate or severe exacerbations on initial therapy. Number of participants with event is presented.|Up to 364 days|ITT Population|||Participants|||Number
2663528|NCT01551758|Secondary|Time to First Moderate/Severe Exacerbations Occurring in a Year|The date of an event for moderate / severe COPD exacerbation was defined as the exacerbation onset date. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. The probability of a first moderate / severe exacerbation was measured from the date of randomisation (i.e., treatment initiation) to the onset date of first moderate or severe COPD exacerbation, as recorded on eCRF, or date of treatment termination (Visit 6 or early withdrawal visit) for participants who completed the study without any moderate or severe exacerbations (censored). Participants who completed the study without a moderate or severe COPD exacerbation and analyses of time to first moderate/severe exacerbation were censored at Day 364. Number of participants with event is presented.|Up to 364 days|ITT Population|||Participants|||Number
2663529|NCT01551758|Secondary|Time to the Addition of a Further COPD Controller Medication Occurring in a Year|The date of an event for addition of a further COPD controller medication was defined as the exposure start date of the first modified treatment medication that included a new COPD maintenance therapy of a new class of drug (to the initial therapy) during the study treatment period, as collected on the investigational product page of the eCRF. Participants who did not add any COPD controller medication during the study were censored at the end of the treatment period (Day 364). This was equivalent to stepping up, defined as the addition of at least one new class of drug. The probability of an event was measured from the date of randomisation (i.e., treatment initiation) to the date of a change event. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. Number of participants with event is presented.|Up to 364 days|ITT Population|||Participants|||Number
2663530|NCT01551758|Secondary|Time to an Event of Discontinuation of Initial Therapy Occurring in a Year|Initial therapy was defined as the treatment that the subject was randomised to at randomisation. Discontinuation of initial therapy was defined as any modification of initial therapy. These included stepping up, stepping down or switching to another class/class combination, or withdrawal from the study. Switching within the same drug class did not count unless participant switched from FF/VI to a different ICS/LABA. The analysis method was a Cox proportional hazards model adjusted for randomized treatment. The probability of discontinuation of initial therapy was measured from the date of randomisation (i.e., exposure start date) to the date of discontinuation of initial therapy to which the participant was randomized, or date of treatment termination (Visit 6 or early withdrawal visit) for participants who completed the study without discontinuing the initial therapy (censored). Number of participants with event is presented.|Up to 364 days|ITT Population|||Participants|||Number
2663531|NCT01551758|Secondary|Number of All Primary Care Contacts Expressed Using Least Square Mean|A primary care contact was defined as contact with a either a nurse, general practitioner, or other healthcare professional. The analysis method was General Linear Model assuming an underlying negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in the previous year to randomisation and smoking status at baseline.|Up to 54 weeks|ITT Population.|||Contacts per participant per year||95% Confidence Interval|Least Squares Mean
2663532|NCT01551758|Secondary|Number of All Secondary Care Contacts Expressed Using Least Square Mean|A secondary care contact was defined as an inpatient admission or a specialist outpatient visit or an A&E contact. A participant with an A&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. In the situation where inpatient admissions were recorded at two hospitals on the same day, this was counted as a single secondary care contact. The analysis method was General Linear Model assuming an underlying negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomization stratification, number of moderate/severe COPD exacerbations in the previous year to randomization and smoking status at baseline.|Up to 54 weeks|ITT Population.|||Contacts per participant per year||95% Confidence Interval|Least Squares Mean
2663533|NCT01551758|Secondary|Number of COPD-related Primary Care Contacts Expressed Using Least Square Mean|A COPD-related primary care contact was defined as a primary care contact on a given calendar date with either a nurse, general physician (GP) or other healthcare professional that were considered as COPD-related, if the most prominent signs and symptoms the participant was presenting were as a direct result of the participant's COPD, as per Readcodes recorded in the patients electronic health record (EHR). The analysis method was General Linear Model assuming an underlying negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in the previous year to randomisation and smoking status at baseline.|Up to 54 weeks|ITT Population.|||Contacts per participant per year||95% Confidence Interval|Least Squares Mean
2663534|NCT01551758|Secondary|Number of COPD-related Secondary Care Contacts Expressed as Least Square Mean|A COPD-related secondary care contact was defined as an inpatient admission or a specialist outpatient visit or an accident & emergency (A&E) contact. A participant with an A&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. Inpatient admissions recorded at two hospitals on the same day, this was counted as a single (inpatient admission) secondary care contact. COPD-related contacts were identified using predefined lists of ICD-10 codes, specialty descriptions and diagnosis codes recorded in the patients electronic health record (EHR). GLM assuming the negative binomial distribution with log-link function and logarithm of time on treatment as an offset variable and adjusted for randomised treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in the previous year to randomisation and smoking status at baseline.|Up to 54 weeks|ITT Population.|||Contacts per participant per year||95% Confidence Interval|Least Squares Mean
2663535|NCT01551758|Secondary|Time to the First Serious Adverse Event of Pneumonia Occuring in a Year|The analysis method was a Cox proportional hazards model adjusted for randomized treatment. Analyses included those on-treatment SAEs of pneumonia that had an onset over the first 364 days of exposure, as defined. Participants who did not have an SAE of pneumonia during the first 364 days of the treatment period (start date of exposure to end date of exposure + 28 days were considered censored. Number of participants with event is presented.|Up to 52 weeks|ITT Population|||Participants|||Number
2663536|NCT01551758|Secondary|Mean Number of Serious Adverse Events of Pneumonia During the Study|The mean number of SAE of pneumonia over the treatment period (from first date of exposure to last date of exposure + 28 days was calculated. Analysis was performed using a negative binomial regression model with covariates of randomised treatment and with logarithm of time on treatment as an offset variable.|Up to 58 weeks|ITT Population.|||Mean Number of SAE||95% Confidence Interval|Least Squares Mean
2663537|NCT01551758|Secondary|Number of Participants With Serious Adverse Events (SAEs) of Pneumonia During the Study|Incidence of SAE of pneumonia was defined for each randomized treatment group as the proportion (number) of participants in that group who experienced at least one SAE of pneumonia in the Pneumonia Adverse Event of Special Interest subgroup during the treatment period (from start date of exposure to stop date of exposure + 28 days). Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2. Serious Adverse Events of pneumonia are defined by the Pneumonia Special Interest Group, which for SAEs of pneumonia collected for these subjects includes the following preferred terms: Pneumonia, Pneumonia aspiration, Aspergillus infection, Empyema, Pneumonia streptococcal, Pneumonitis, Pulmonary tuberculosis.|Up to 58 weeks|The Intent-to-Treat (ITT) Population: Defined as all participants who were randomised and received at least one prescription of study medication|||Participants|||Number
2663538|NCT01551758|Primary|Mean Annual Rate of Moderate or Severe COPD Exacerbations|Mean annual rate of moderate or severe COPD exacerbations during treatment were assessed. Moderate exacerbation: participant received exacerbation-related prescription of oral corticosteroids and/ or antibiotic (with/without National Health Service [NHS] contact) not requiring hospitalisation. Severe exacerbation: an exacerbation-related hospitalisation. Analysis method was Generalised Linear Model (GLM) assuming the negative binomial distribution with a log-link function and logarithm of time on treatment as an offset variable, adjusted for randomized treatment, baseline COPD maintenance therapy per randomisation stratification, number of moderate/severe COPD exacerbations in previous year and smoking status at baseline. Intent to treat (ITT) population: all randomised participants who received a prescription of study medication. Primary Efficacy Analysis Population: all ITT participants who had at least one moderate/severe exacerbation in the year prior to randomization|Up to 54 weeks|Primary Efficacy Analysis Population.|||Exacerbations per participant per year||95% Confidence Interval|Least Squares Mean
2663539|NCT01551745|Secondary|Enzyme-Linked ImmunoSorbent Spot (ELISPOT)|To determine if subjects will have a positive (defined as >10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until 30 days after last dose.|Baseline, End of Treatment (30 days after last dose) up to 12 months|5 subjects were enrolled and started Vigil treatment. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1). After 12 months, all 5 subjects had positive ELISPOT response. Statistical analysis was not done. This study was terminated.|||Participants|||Count of Participants
2663540|NCT01551745|Secondary|Number of Alive Subjects|Survival status of patients after treatment was determined by following these patients up to 24 months.|24 months|5 subjects were enrolled and started Vigil treatment. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1). After 24 months, only 1 of the 5 subjects was alive. Statistical analysis was not done. This study was terminated.|||Participants|||Count of Participants
2663541|NCT01551745|Primary|Response Rate|Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.|Up to 12 months|5 subjects were enrolled and started Vigil treatment. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1). There is no Outcome Measure Data table because Time to Progression (TTP) and Response Rate (RR) were not collected and analyzed. This study was terminated.||||||
2663542|NCT01551745|Primary|Time to Progression|Time to progression (TTP) following bevacizumab integrated with Vigil vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production. This will be measured from the treatment start date (date of first dose) to either the date the patient is first recorded as having disease recurrence (even if the patient went off treatment because of toxicity), or the date of death if the patient dies due to any causes before progression.|24 months|5 subjects were enrolled and started Vigil treatment. 2 subjects completed treatment and 3 did not complete treatment due to disease progression (2) and withdrawal of consent (1). There is no Outcome Measure Data table because Time to Progression (TTP) and Response Rate (RR) were not collected and analyzed. This study was terminated.||||||
2663543|NCT01551693|Secondary|Overall Survival|Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.|Patients were followed every 4 weeks for survival until death, lost to follow-up or study closure (approximately 6 months after the last patient ended treatment). In this study cohort, patients were followed up to 13 weeks.|Overall survival was not estimated given the limited sample size.||||||
2663544|NCT01551693|Secondary|Best Overall Response|Best overall response (BOR) on treatment was based on RECIST 1.0 criteria. For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR confirmation required within 4 weeks. Progressive disease (PD) is at least a 20% increase in the sum LD of target lesions from smallest sum LD as reference or the appearance of one or more new lesions. Stable disease (SD) is neither meeting PR or PD. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions. CR is disappearance of all non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment. Median (range) treatment duration was 1 cycle/4 weeks (1-2 cycles; 4-8 weeks).||||participants|||Number
2663568|NCT01551212|Secondary|Estimated GFR - PP Set|This was a sensitivity analysis for the primary outcome measure based on the per-protocol set of patients.|month 12|Per Protocol Set (PP)|||mL/min||Standard Deviation|Mean
2663545|NCT01551693|Primary|6-month Progression-Free Survival Rate|6-month progression-free survival rate was defined as the proportion of patients absent death or progression based on Response Evaluation Criteria In Solid Tumors Criteria (RECIST) before 6 months. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.|Disease was evaluated radiologically at baseline and every 8 weeks on treatment; Treatment continued until evidence of disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 6 months.||||proportion of participants|||Number
2663546|NCT01551550|Secondary|GDD Failure|GDD Failure, based on reoperation to control the IOP, and also include the defined by the following criteria: (1) IOP ≥21 mm Hg or not reduced by 30% below baseline on two consecutive follow-up visits after 3 months. (2) IOP ≤5 mm Hg on two consecutive follow-up visits after 3 months. (3) Additional glaucoma surgery. (4) Loss of light perception vision.|2 years|||||||
2663547|NCT01551550|Primary|Tube Exposure|Impending conjunctival erosion can be indicated by loss of conjunctival capillaries over the tube, usually 1 to 3 mm from the corneoscleral junction. Definitive tube exposure is accompanied by conjunctival tissue loss, graft melting.|2 years||||Participants|||Count of Participants
2663548|NCT01551420|Secondary|The Community Reintegration of Service Members Computer Adaptive Test (CRIS-CAT)|The CRIS measures community reintegration. It consists of three scales extent and frequency, perceived limitations, and satisfaction. Higher scores (range 0-100) indicate better community integration.|Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)|Baseline participants and completers at End of A and End of B|||score on a scale||Standard Deviation|Mean
2663549|NCT01551420|Secondary|Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS)|The UEFS is a self-report measure developed for use with upper limb adult amputees. It includes 23 activities: selfcare, instrumental, and daily living tasks using a 5-point scale from 1=Very Easy to 5=Cannot perform. Total score was calculated using IRT methods and ranged from 0 to 100 with lower scores reflecting better function.|Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)|Baseline participants and completers at End of A and End of B.|||score on a scale||Standard Deviation|Mean
2663550|NCT01551420|Secondary|Timed Measure of Activity Performance (T-MAP)|The T-MAP is a performance measure of daily activities for persons with upper limb amputation utilizing 5 every day activities. Time (seconds) to completion of activity is measured and summed to obtain overall timed score. Lower overall scores (less time taken) indicate better / faster activity performance|Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)|Baseline participants and completers at End of A and End of B|||Seconds||Standard Deviation|Mean
2663551|NCT01551420|Secondary|University of New Brunswick Test of Prosthetic Function (UNB)|This test is performed with unilateral amputees only. The subtest used includes wrapping a parcel, sewing a button on cloth, cutting meat, drying dishes, sweeping floor, and using a dustpan and brush. Each task was rated for both spontaneity and skill. UNB Spontaneity: Spontaneity rates spontaneity of prosthesis use (0=prosthesis not used to 4=immediate, consistent use of terminal device. UNB Skill: rates skill of performing the activities (0 = prothesis not used to 4 = active terminal device is quick & smooth). Summary scores are calculated for each subscale by averaging items and range from 0 to 4 with higher scores reflecting higher spontaneity and skill.|Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)|Prosthesis users only, at baseline, completers at End of A and End of B.|||score on a scale||Standard Deviation|Mean
2663552|NCT01551420|Secondary|Jebsen-Taylor Hand Function Test (JTHFT) 7 Subtests|"JTHFT Writing: Evaluates the time needed to print a 24-letter, third-grade reading difficulty sentence. JTHFT Page turning: Evaluates the time needed to turn over 7.6 x 12.7 cm (3x5) cards in simulated page turning. JTHFT Small objects: Evaluates the time needed to perform pick up small common objects including pennies, paper clips, bottle caps and placing them in a container. JTHFT Stacking checkers: Evaluates the time needed to stack four checkers. JTHFT Simulated feeding: Evaluates the time needed to perform simulated feeding. JTHFT Moving large empty cans: Evaluates the time needed to move large empty cans. JTHFT Moving large 1 lb. cans: Evaluates the time needed to move 1 lb. cans. All subtests are modified to cap the maximal time for the subtask at 120 seconds and is scored as the number of items completed per second."|Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)|Prosthesis users only, at baseline, completers at End of A and End of B.|||items completed per second||Standard Deviation|Mean
2663553|NCT01551420|Secondary|Three Scales of the Veterans Version of the SF-36|Role Physical: measures role physical function with 4 items referring to role limitations due to physical health. Items are rated from 1=none of the time to 5=All of the time. Social Functioning: measures social functioning with 2 items referring to problems interfering with socializing with friends and family. One item is rated extent of problems as 1=Not at all to 5=Extremely and is reverse coded. All other items are rated as problem frequency from 1=All of the time to 5=None of the time. The mean score is scaled to range between 0 to 100. Physical Functioning: measures physical functioning with 10 items pertaining to moving, lifting and walking. Items are rated from 1=Limited a lot to 3=Not limited at all. The mean score is scaled to range between 0 to 100. In all scales, higher scores correspond to higher quality of life.|Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)|Baseline participants and completers at End of A and End of B|||score on a scale||Standard Deviation|Mean
2663554|NCT01551420|Secondary|Activities Measure for Upper Limb Amputees (AM-ULA)|The AM-ULA is an 18-item measure assessing functional performance with a prosthesis: ability of the amputee to complete daily activities, speed of the performance, movement quality, skillfulness of prosthetic use and independence. Items are rated 0=Unable to perform task to 4=Excellent Performance. Average score is multiplied by 10 and has a range from 0 (lowest functional performance) to 40 (highest functional performance).|Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)|Prosthesis users only, at baseline, completers at End of A and End of B.|||units on a scale||Standard Deviation|Mean
2663555|NCT01551420|Secondary|Trinity Amputations and Prosthetics Experience Scale (TAPES) Satisfaction Scale|The TAPES Satisfaction scale is a 10-item scale measuring extent of satisfaction regarding functional characteristics of the artificial limb: reliability, comfort, fit, and overall satisfaction, contentment with cosmetic characteristics of the device. Each item is rated from 1-5 (1=Very Dissatisfied to 5=Very Satisfied). The average score is used.|Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)|Prosthesis users only, at baseline, completers at End of A and End of B.|||score on a scale||Standard Deviation|Mean
2663556|NCT01551420|Secondary|Upper Extremity Functional Scale (UEFS) From the Orthotics and Prosthetics Users Survey (OPUS) Use Scale|Measures the engagement of the prosthesis in everyday activities using 23 items from the OPUS UEFS. Respondents indicate which activities they performed using a prosthesis. The score is the proportion of activities performed using a prosthesis.|Baseline, end of Part A (variable time frame depending on training schedule), after 9-12 weeks of home use (end of Part B)|Prosthesis users only, at baseline, completers at End of A and End of B.|||proportion of activities performed||Standard Deviation|Mean
2663557|NCT01551420|Primary|Change in Quality of Life (QOL) Scale|The QOL consists of 16 questions that assess satisfaction with independent living and self-care activities. Each item is rated (1=Terrible to 7=Delighted). The average of these 16 items is the summary score with higher values reflecting higher satisfaction. The primary outcome is the net change in summary score between baseline and end of Part B.|baseline and after 9-12 weeks of home use (end of Part B)||||score on a scale||Standard Deviation|Mean
2663558|NCT01551355|Secondary|Body Mass Index - BMI|The body mass index (BMI), or Quetelet index, is a measure of relative weight based on an individual's mass and height = Kg/m²|baseline||||Kg/m²||Standard Deviation|Mean
2663559|NCT01551355|Secondary|KAH Score for Teachers|"Change in Weighted knowledge, attitude, habit (KAH) score (70/20/10) among teachers after 5 months of intervention as compared to prior to intervention.~Because we hypothesized that the mean change in knowledge scores associated with this short intervention period would be larger than the mean changes in scores due to attitudes and habits, we a priori gave differential weights (70, 20, and 10, respectively) to the scores to compose a standardized weighted total score (WTS).~We developed questionnaires to measure knowledge, attitudes, and habits on healthy eating and living an active lifestyle in children, parents, and teachers.~Scale range: 0-100 Knowledge scale range: 0-100 Attitude scale range: 0-100 Habit scale range: 0-100 WTS (weighted total score) scale range: 0-100 Higher values represent a better outcome"|at baseline and at 6 months|Change in weighted total score controlling for Cluster Effect, Sex, Age, Children’s Weight, and Teacher’s Educational Level after 5-Month Intervention. Data available only for 37 teachers in healthy habits arm and 35 teachers in usual curriculum arm.|||units on a scale||95% Confidence Interval|Mean
2663560|NCT01551355|Secondary|KAH Score for Parents|"Change in Weighted knowledge, attitude, habit (KAH) score (70/20/10) among parents after 5 months of intervention as compared to prior to intervention.~Because we hypothesized that the mean change in knowledge scores associated with this short intervention period would be larger than the mean changes in scores due to attitudes and habits, we a priori gave differential weights (70, 20, and 10, respectively) to the scores to compose a standardized weighted total score (WTS).~Questionnaires were developedheae to measure knowledge, attitudes, and habits on healthy eating and living an active lifestyle in children, parents, and teachers.~Scale range: 0-100 Knowledge scale range: 0-100 Attitude scale range: 0-100 Habit scale range: 0-100 WTS (weighted total score) scale range: 0-100 Higher values represent a better outcome"|at baseline and at 6 months|Change in weighted total score controlling for Cluster Effect, Sex, Age, Children’s Weight, and Teacher’s Educational Level after 5-Month Intervention. Data available only for 402 parents in healthy habits arm and 360 parents in usual curriculum arm.|||units on a scale||95% Confidence Interval|Mean
2663561|NCT01551355|Primary|Change in KAH Score for Children|"Change in weighted knowledge, attitude, habit (KAH) (70/20/10) score among children after 5 months of intervention as compared to prior to intervention.~The study hypothesized that the mean change in knowledge scores associated with this short intervention period would be larger than the mean changes in scores due to attitudes and habits, differential weights (70, 20, and 10, respectively) were given to the scores a priori to compose a standardized weighted total score (WTS).~The developed questionnaires measured knowledge, attitudes, and habits on healthy eating and living an active lifestyle in children, parents, and teachers.~Scale range: 0-100 Knowledge scale range: 0-100 Attitude scale range: 0-100 Habit scale range: 0-100 WTS (weighted total score) scale range: 0-100~Higher values represent a better outcome"|at baseline and at 6 months|"The analysis was done with children that answered al questions in 3 topics: knowledge, attitudes and habits.~Change Score in Weighted total score controlling for Cluster Effect, Sex, Age, Children’s Weight, and Teacher’s Educational Level after 5-Month Intervention."|||units on a scale||95% Confidence Interval|Mean
2663562|NCT01551303|Primary|Affective Ratings in Affective Learning Task|"We will measure the effect of the drug on affective learning, using the Affective Learning Task. Participants viewed 30 neutral faces, each paired with one sentence describing a negative positive, or neutral behavior, counterbalanced across participants. During the test phase, participants will rate the faces as negative, neutral, or positive. These ratings were averaged. Responses were coded as: negative = -1, neutral = 0, positive =1, so the averaged scores have a possible range between -1 and 1. Since this is not a treatment study for a disease, there is so better or worse outcome."|30 minutes after drug administration||||units on a scale||Standard Error|Mean
2663563|NCT01551212|Secondary|Incidence and Severity of CMV Viral Infections.|Incidence and severity of cytomegalovirus (CMV) viral infections assessed as treatment emergent adverse events of special interest.|12 months|Safety Set|||Participants|||Count of Participants
2663564|NCT01551212|Secondary|Incidence of de Novo HCC Malignancies|Incidence of de novo Hepatocellular Carcinoma (HCC) malignancies assessed as treatment emergent adverse events of special interest|12 months|Safety Set|||Participants|||Count of Participants
2663565|NCT01551212|Secondary|Incidence of HCV Related Fibrosis|Incidence of hepatitis C virus (HCV) related fibrosis assessed as treatment emergent adverse events of special interest|12 months|Safety Set|||Participants|||Count of Participants
2663566|NCT01551212|Secondary|Number of Participants With HCV|Number of Participants with HCV (hepatitis C virus) assessed as treatment emergent adverse events of special interest|12 months|Safety Set|||Participants|||Count of Participants
2663569|NCT01551212|Primary|Estimated Glomerular Filtration Rate (GFR)|The estmated GFR was calculated using MDRD-4 formula (Modification of Diet in Renal Disease Study Group).|month 12|FAS (Full Analysis Set - All Randomized AND Treated Patients) with LOCF (last observation carried forward)|||mL/min||Standard Deviation|Mean
2663570|NCT01551199|Primary|Clinician Administered PTSD Scale (CAPS)|The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (daily/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.|3-month follow-up (approximately week 26)||||units on a scale||Standard Deviation|Mean
2663571|NCT01551199|Secondary|Anxiety Disorders Interview Schedule- DSM-IV (ADIS-IV)|The ADIS-IV is a semi-structured diagnostic interview for anxiety disorders (based on DSM-IV criteria). DSM-IV criteria for panic disorder include recurrent unexpected panic attacks and (1) persistant concern or worry about additional panic attacks or their consequences or (2) significant change in behavior related to panic attacks.|3 Months||||percentage of participants|||Number
2663572|NCT01551199|Primary|Clinician Administered PTSD Scale (CAPS)|The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (daily/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.|1-week post-treatment (approximately week 14)||||units on a scale||Standard Deviation|Mean
2663573|NCT01551186|Primary|Number of Participants With Combination of Gastrointestinal Tract Colonization With Multi-drug Resistant Gram-negative Bacteria, C. Difficile and VRE|Colonization of the gastrointestinal tract with C. difficile, vancomycin-resistant enterococci, multidrug-resistant Acinetobacter baumannii, and multidrug- resistant Pseudomonas. Colonization occurs when the subject acquires the above organism while in the study.|Participants will be followed while Intubated, an expected average of 7 days. The outcome will be measured 3 days after enrollment and at the end of intubation, average time 7 days)||||Participants|||Count of Participants
2663574|NCT01551173|Secondary|Proportion of Patients Achieving Their LDL-C Treatment Goals at Week 4, Week 8, Week 12, and Endpoint|LDL-C treatment goal is defined as patients at moderate CV risk with LDL-C levels < 3.37 mmol/L (130 mg/dL) or patients at high CV-risk with LDL-C levels < 2.59 mmol/L (100 mg/dL). The proportion of patients in each treatment group achieving their LDL-C goal during the double-blind period will be compared at Week 4, Week 8, Week 12 and Endpoint using a logistic regression model with treatment and center as factors and baseline LDL-C as a covariate. Odds ratio estimates derived from the logistic regression model and 95%CI will be used to quantify the treatment effect.|Baseline, week 4, week 8, week 12, Endpoint|FAS: all randomized patients who received at least one dose of double-blind study medication and one post-randomization efficacy parameter measurement. The intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Endpoint: final available post-baseline assessment to last scheduled visit|||Percent of participants|||Number
2663575|NCT01551173|Secondary|Change From Baseline at Week 4, Week 8, Week 12, and Endpoint for Lipid Variables Low Density Lipoprotein Cholesterol (LDL-C) , Total Cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C) , Non HDL-C, Triglycerides (TG)|After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn. An analogous ANCOVA model to that used in the analysis of the primary variable will be used to compare the change in LDL-C, TC, HDL-C, non HDL-C and TG from baseline between treatment groups at Week 4, Week 8, and Week 12|Baseline, week 4, week 8, week 12, Endpoint|FAS: all randomized patients who received at least one dose of double-blind study medication and one post-randomization efficacy parameter measurement. The intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Endpoint: final available post-baseline assessment to last scheduled visit|||mmol/L||Standard Error|Mean
2663576|NCT01551173|Primary|Mean Percent Change in LDL-C From Baseline at Study Endpoint, Week 12 (LOCF)|After the patient has been sitting for at least 5 minutes, a 12 hour fasting blood sample will be withdrawn at baseline and endpoint. An analysis of covariance (ANCOVA) with treatment, center, and indication category as factors and baseline LDL-C as a covariate will be used to analyze percent change from baseline in LDL-C.|Baseline, week 12|FAS: all randomized patients who received at least one dose of double-blind study medication and one post-randomization efficacy parameter measurement. The intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization. Endpoint: final available post-baseline assessment to last scheduled visit|||Percent change||Standard Error|Mean
2663577|NCT01551095|Secondary|Number of Participants With Retrograde Migration of PEGJ Feeding Tube Within 3 Weeks of Placement|An Abdominal X-ray was obtained 3 weeks after the procedure to check whether or not there was any PEGJ feeding tube migration.|From date of PEGJ placement up to 3 weeks||||participants|||Number
2663578|NCT01551095|Primary|Safety: Number of Participants With Adverse Events|One week after the procedure patients were called by one of the study investigators and were asked whether or not they had Abdominal pain, Nausea or Vomiting after the procedure.|From date of PEGJ placement up to 3 weeks||||participants|||Number
2663579|NCT01551082|Primary|Outpatient Chest Tube Management Following Thoracic Resection Improves Patient Length of Stay and Satisfaction Without Compromising Outcomes|Outcome measures for this study were to correlate outpatient chest tube management with patient satisfaction. Also to correlate decreased length of stay without compromising any patient outcomes.|2 years|Study was terminated and no data were collected for the outcome||||||
2663580|NCT01551056|Secondary|Tolerability of Study Medication at Visit 3A|Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.|upon instillation, 1 minute and 2 minutes post instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2663648|NCT01550367|Secondary|T-cell Lymphocytes|Percentage of T-cell lymphocytes in blood as cells per ml. T-cells are a subtype of white blood cells which play a key role in the immune system and fighting cancer.|Up to 3 years|Patients that received study treatment for whom T-Cells were able to be measured.|||percentage of cells/mL||Full Range|Mean
2663581|NCT01551056|Secondary|Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||%participants with at least 1 nasal symp|||Number
2663582|NCT01551056|Secondary|Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||%participants with at least 1 nasal symp|||Number
2663583|NCT01551056|Secondary|Nasal Congestion at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
2663584|NCT01551056|Secondary|Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
2663585|NCT01551056|Secondary|Ear or Palate Pruritis at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
2663586|NCT01551056|Secondary|Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
2663587|NCT01551056|Secondary|Nasal Pruritis at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
2663588|NCT01551056|Secondary|Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
2663589|NCT01551056|Secondary|Rhinorrhea at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
2663590|NCT01551056|Secondary|Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
2663591|NCT01551056|Secondary|Tearing at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
2663592|NCT01551056|Secondary|Tearing at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
2663593|NCT01551056|Secondary|Eyelid Swelling at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
2663594|NCT01551056|Secondary|Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
2663595|NCT01551056|Secondary|Chemosis at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
2663688|NCT01550224|Secondary|Overall Survival (OS) at 2 Years|Overall Survival (OS) is defined as survival regardless of clinical status. OS is reported as the percentage without dispersion of participants in Groups 1 and 2 that remained alive 2 years after induction chemotherapy.|2 years||||Participants|||Count of Participants
2663596|NCT01551056|Secondary|Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
2663597|NCT01551056|Secondary|Episcleral Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
2663598|NCT01551056|Secondary|Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
2663599|NCT01551056|Secondary|Ciliary Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
2663600|NCT01551056|Secondary|Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT) with observed data only.|||units on a scale||Standard Deviation|Mean
2663601|NCT01551056|Primary|Conjunctival Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2663602|NCT01551056|Primary|Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2663603|NCT01551056|Primary|Ocular Itching at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2663604|NCT01551056|Primary|Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose)|A treatment efficacy Conjunctival Allergen Challenge (CAC) was performed 16 hours + 1 hour after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2663605|NCT01550965|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Activity Impairment|WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.|||percentage of activity impairment||Standard Deviation|Mean
2663606|NCT01550965|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Overall Work Impairment Percentage|WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The overall work impairment data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.|||percentage of overall work impairment||Standard Deviation|Mean
2663607|NCT01550965|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Impairment While Working|WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. The scores on the WPAI questionnaire are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change in WPAI-SHP was calculated by deducting the final score from the baseline score. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The percentage of impairment while working data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.|||percentage of impairment while working||Standard Deviation|Mean
2663757|NCT01549041|Primary|Patient Acceptance|A Patient Acceptance Likert Scale (1= Very Acceptable to 7 = Completely Unacceptable, i.e., individual refuses further doses) will be administered to the patient by the Research Nurse on day 14 of treatment.|At day 14||||units on a scale||Standard Error|Mean
2663608|NCT01550965|Secondary|Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Work Time Missed|WPAI-SHP is a questionnaire used to assess the effect of the participant's health problems on their ability to work and perform regular activities. A higher score indicates an increased impairment. A positive value of change indicates an increased impairment of work productivity and the limitation of activities of daily life, while a negative value indicates an improvement. The percentage of work time missed data was applicable to employed participants only. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.|||percentage of work time missed||Standard Deviation|Mean
2663609|NCT01550965|Secondary|Mean Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Total Score|EQ-5D-5L Total Score provides a descriptive profile of health status. It comprises of 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores ranging from 1 (no problems) through 5 (extreme problems). A unique EQ-5D-5L health state was defined by combining the numeric level scores for each of the 5 dimensions and the total score ranges from -0.594 to 1, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
2663610|NCT01550965|Secondary|Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI)|The SCCAI measures disease activity as assessed by the investigator and includes the following 6 items: bowel frequency (day), bowel frequency (night), urgency of defecation, blood in stool, general well-being and extra colonic features. The score ranges from 0 (best) to 19 points (worst).|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
2663611|NCT01550965|Secondary|Mean Change From Baseline in Physician's Global Assessment (PGA)|The Physician's Global Assessment was used to measure the participant's disease activity. The physician considered the participant's reported information such as number of stools, rectal bleeding, abdominal discomfort, and functional assessment during the previous day prior to the visit, and other observations such as physical findings, and the participant's performance status at the time of the visit. Based on the above information the investigator made an overall assessment of participant's current severity of UC using the ordinal scale from 0 (normal) to 3 (severe disease).|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
2663612|NCT01550965|Secondary|Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score Over Time|The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, used to detect changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL). N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
2663613|NCT01550965|Secondary|Percentage of Participants With Absence of Blood in Stool|Participants with absence of blood in stool were reported.|Week 26|All participants in the ITT population with evaluable data.|||percentage of participants|||Number
2663614|NCT01550965|Secondary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Outpatient Utilization, Including Emergency Department Visits, Unscheduled Consultation, Exam Procedures|UC-related outpatient utilization was determined from the health care utilization information. Outpatient utilization was the number of procedures/surgeries performed during outpatient visits. Participants without any outpatient utilization were excluded.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.|||Procedures/ Surgeries||Standard Deviation|Mean
2663615|NCT01550965|Secondary|Mean Change From Baseline in Participant's Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM)|TSQM is a questionnaire to be completed by the participants to determine their satisfaction of the medications for ulcerative colitis including the study drug. The TSQM is a 14-item subject-rated scale that evaluates the effectiveness, side effects, convenience, and global satisfaction of the medication over the past 2-3 weeks. Each of the 14 questions are scored from 1 (worst) to 7 points (best); and each of the domains are scored from 0 (less satisfaction) to 100 (better satisfaction). N = participants with evaluable baseline and post-baseline data.|Week 0 (baseline) and Week 26|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
2663616|NCT01550965|Secondary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related and All-cause Hospitalization|Hospitalization was defined as number of bed days in hospital as determined from the health care utilization information.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.|||Days||Standard Deviation|Mean
2663617|NCT01550965|Secondary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Direct and Indirect Health Care Costs|UC-related direct and indirect health care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments, medications and indirect costs based on WPAI.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.|||Pound Sterling (GBP)||Standard Deviation|Mean
2663646|NCT01550510|Primary|Number of Participants That Experience Serious Adverse Events as Defined by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.|Safety: The primary aim is to assess whether or not (IV) Ascorbic Acid (AA) with irinotecan therapy is relatively safe and well-tolerated according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0.|9 weeks +/- 2 weeks|The study was closed early due to lack of accrual. The data were not collected or analyzed.||||||
2663618|NCT01550965|Secondary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Total All-cause Direct Health Care Costs (Excluding Adalimumab Costs)|Medical care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments and medications.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.|||Pound Sterling (GBP)||Standard Deviation|Mean
2663619|NCT01550965|Primary|Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Costs of UC-related Medical Care Excluding Adalimumab Costs|Medical care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments and medications.|6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)|All participants in the ITT population with evaluable data.|||Pound Sterling (GBP)||Standard Deviation|Mean
2663620|NCT01550965|Primary|Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score|The SIBDQ is a disease-specific health-related quality of life (HRQOL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions; each question is scored on a scale from 1 (poor QOL) to 7 (optimum QOL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL).|Week 0 (baseline) and Week 26|All participants in the ITT population with evaluable data.|||units on a scale||Standard Deviation|Mean
2663621|NCT01550952|Secondary|Total Oral Opioid Intake in 48hrs|Opioid Usage|0-48hrs||||mg||Standard Deviation|Mean
2663622|NCT01550952|Secondary|Numeric Rating Scale (NRS) Pain Scores With Movement|NRS pain scores (0-10; 0 = no pain, 10 = worst pain possible) assessed.|2 days postoperatively||||units on a scale||Inter-Quartile Range|Median
2663623|NCT01550952|Secondary|Number of Participants With Reduced Sensation in a Dermatome|Pin-prick sensation assessed.|2 days postoperatively|Dermatomes could not be assessed for one patient due to sedation|||participants|||Number
2663624|NCT01550952|Primary|Hand Grip Strength|Hand grip strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).|2 days postoperatively|One participant declined assessment due to soreness in the shoulder muscle.|||percent||Inter-Quartile Range|Median
2663625|NCT01550952|Primary|Anterior Deltoid Strength|Anterior deltoid strength as measured by a dynamometer. Percentage change in measure as compared to post-surgery (with post-surgery measure at 0%).|2 days postoperatively|One participant declined assessment due to soreness in the shoulder muscle.|||percent||Inter-Quartile Range|Median
2663626|NCT01550809|Secondary|The Area Under the Curve (AUC) of Plasma Glucose (PG) Above the Threshold of 140 mg/dl (AUC-PG>140).|"The AUC-PG>140 during the 5-hour period following the meal test represents the hyperglycemic risk related to the modality of prandial insulin administration.~Plasma glucose (PG) for calculation of AUC-PG>140 was measured every 15 minutes following the insulin administration and during the whole 5-hour postprandial period (300 minutes)."|The whole experiment, i.e. the 5-hour postprandial period||||mg*h/dl||Standard Deviation|Mean
2663627|NCT01550809|Primary|The Area Under the Curve (AUC) of the Glucose Infusion Rate (GIR) During the 5-hour Postprandial Period (AUC-GIR0-5h).|"The amount of glucose infused during the 5-hour postprandial period (AUC-GIR0-5h) is a measure of the hypoglycemic exposure associated with the modality of prandial insulin administration. Indeed, glucose will be infused only when patients are under a predefined blood glucose values (80 mg/dl) with a descending trend.~Glucose infusion rate (GIR) for calculation of AUC-GIR was measured every minute following the insulin administration and during the whole 5-hour postprandial period (300 minutes)."|The whole experiment, i.e. 5 hours.||||mg/kg||Standard Deviation|Mean
2663628|NCT01550809|Primary|The Area Under the Curve (AUC) of Plasma Glucose (PG) Concentrations During the 5-hour Postprandial Period (AUC-PG0-5 h).|"AUC-PG0-5 h (5-hour postprandial glucose following the mixed meal test) is a measure of the overall glucose-lowering efficacy of the insulin bolus. The lower the AUC-PG0-5 h without hypoglycemia, the greater the effectiveness of the prandial insulin administration to control the meal related glucose excursion.~Plasma glucose (PG) for calculation of AUC-PG was measured every 15 minutes following the insulin administration and during the whole 5-hour postprandial period (300 minutes)."|The whole experiment, i.e. 5 hours|This was a proof-of-concept study. However, as an estimation of N, a two-sided t-test achieved 84% power to infer that the mean difference was not 0 when the total sample size of a 2x2 crossover design was 12, the actual mean difference in the AUC-PG0-5 h was 100mg*dl-1*h, the square root of the within mean square error was 75.0 and alpha was 0.05.|||mg*h/dl||Standard Deviation|Mean
2663629|NCT01550757|Primary|A Primary Outcome for This Study is the Number of Non-acute Emergency Department Visits.|A primary outcome for this study is non-acute emergency department visits.|Two years.|Veterans enrolled in the study based on the type of care they received at VA and then randomized to receive a peer or not.|||number of visits||Standard Deviation|Mean
2663630|NCT01550744|Secondary|The Percentage of Participants With a PASI 75 Response Over Time|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (>=) 75 percent (%) improvement in PASI score from baseline.|Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112|The Analysis population was “subjects randomized at Week 28 data set”. 'n' signifies number of participants who were evaluable at each specific timepoint, for each arm, respectively.|||percentage of participants|||Number
2663631|NCT01550744|Secondary|The Number of Visits for Which Participants Achieved a Psoriasis Area and Severity Index (PASI) 75 Response|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 to 72. A PASI 75 response is defined as greater than or equal to (>=) 75 percent (%) improvement in PASI score from baseline.|Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])|The “subjects randomized at Week 28 data set” was defined as the population of enrolled participants who were randomized to either Group 1 or Group 2 at Week 28.|||number of visits||Standard Deviation|Mean
2663632|NCT01550744|Secondary|The Percentage of Participants With a Static PGA Score of Cleared (0) or Minimal (1) Over Time|Clinical responses for week (wk) 28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe.|Week 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112|The Analysis population was “subjects randomized at Week 28 data set”. 'n' signifies number of participants who were evaluable at each specific timepoint, for each arm, respectively.|||percentage of participants|||Number
2663633|NCT01550744|Primary|The Number of Visits at Which Participants Achieved a Static Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1)|Clinical responses for week (wk)28 sPGA responders randomized to every 12 weeks (q12wk) fixed-interval dosing (Group 1) vs. patient-tailored fixed-interval dosing (Group 2) were assessed using the static PGA (sPGA) measure. Investigators graded psoriasis lesions for induration (0=no plaque elevation to 5=severe plaque elevation), erythema (0=no evidence of erythema to 5=dusky to deep red coloration), and scaling (0=no evidence of scaling to 5=severe scaling). The sum of the 3 scales is divided by 3 and rounded to obtain a final sPGA score, defined as 0=cleared (except for residual discoloration), 1=minimal, 2=mild, 3=moderate, 4=marked or 5=severe.|Up to 24 weeks (Week 88 up to Week 112 [total 7 visits])|The “subjects randomized at Week 28 data set” was defined as the population of enrolled participants who were randomized to either Group 1 or Group 2 at Week 28.|||number of visits||95% Confidence Interval|Mean
2663634|NCT01550731|Secondary|Self-reported Engagement in Advance Care Planning (ACP) Behaviors|Secondary outcome was chosen to measure the full process of Advance Care Planning (ACP) using validated questionnaires, such as the patient-reported ACP Engagement Survey. This questionnaire includes Behavior Change Process measures. Behavior Change Process measures include knowledge, contemplation, self-efficacy, and readiness for several ACP actions. The Process measures are assessed on an average 5-point Likert scale with a low of 1 and a high of 5, with high scores indicating more ACP engagement. The investigators used mixed effects models to create an overall adjusted score.|6 months||||score on a scale||Standard Deviation|Mean
2663635|NCT01550731|Primary|New Advance Care Planning Documentation in the Medical Record at 9 Months|The primary outcome is documentation of advance care planning wishes in the medical record. ACP documentation for the purposes of this study includes the easy-to-read advance directive or other valid advance directives or living wills, a durable power of attorney for healthcare document (DPOAHC), a physicians orders for life sustaining treatment (POLST) form, or other documentation of patients wishes for medical care (ie, documentation of oral directives by a physician, or code status, such as full code or do not resuscitate or do not intubate orders or notes by a physician).|9 months after study enrollment||||percentage of participants|||Number
2663636|NCT01550705|Secondary|Participants With Increased Sun Sensitivity|Study participants were asked to report after 3 months if they had experienced an increase in subjective measures of sun sensitivity during the trial. Reported outcome is the number of study participants who reported increased sun sensitivity|Baseline and 3 Months||||participants|||Number
2663637|NCT01550705|Primary|Change in Plasma Protoporphyrin IX Level|Plasma Protoporphyrin IX will be measured at baseline and at 3 months|Baseline and 3 Months||||µg/dL||Standard Deviation|Mean
2663638|NCT01550549|Post-Hoc|Individual Reader Results (Autopsy Within 1 Year of Scan)|Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 28 positive and 18 negative scans based on histopathology at autopsy.|Baseline scan||||florbetapir scans|||Number
2663639|NCT01550549|Post-Hoc|Individual Reader Results (All Scans With Autopsy)|Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 39 positive and 20 negative scans based on histopathology at autopsy.|Baseline scan||||florbetapir scans|||Number
2663640|NCT01550549|Other Pre-specified|Median Sensitivity and Specificity vs. CERAD Diagnosis|Median sensitivity and specificity for 5 independent readers to detect moderate to frequent amyloid plaques (per CERAD criteria).|Baseline scan||||percentage of true positives/negatives||Full Range|Median
2663641|NCT01550549|Post-Hoc|Inter-reader Reliability|Measure of agreement among multiple readers using binary read method (Fleiss' kappa). Where available, histopathology analysis at autopsy was the truth standard (TS).|Scan acquired 50-60 min post-injection|59 from study A07(NCT00857415)/A16(NCT01447719) and 92 from study A05(NCT00702143)|||kappa statistic||95% Confidence Interval|Number
2663642|NCT01550549|Secondary|Specificity of Florbetapir-PET to Detect no or Sparse Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease)|Calculated as the percent of true negatives which are correctly identified|at autopsy, within 2 years of scan||||percentage of negative cases IDed||95% Confidence Interval|Number
2663643|NCT01550549|Secondary|Sensitivity of Florbetapir-PET to Detect Moderate to Frequent Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease)|Calculated as the percent of true positives which are correctly identified|at autopsy, within 2 years of scan||||percentage of positive cases IDed||95% Confidence Interval|Number
2663644|NCT01550549|Primary|Inter-rater Reliability|Measure of agreement among five readers using a binary read method (amyloid positive/negative) calculated using Fleiss' kappa. All scans were read in a blinded fashion without access to clinical information.|Scan acquired 50-60 min post-injection|59 autopsy subjects (study A07[NCT00857415]/A16[NCT01447719]) + 20 healthy controls + 20 mild cognitive impairment + 20 AD (from study A05[NCT00702143])|||kappa statistic||95% Confidence Interval|Number
2663645|NCT01550510|Secondary|Number of Participants That Are Alive After 11 Weeks.|To evaluate progression-free survival related to treatment of patients with advanced or recurrent colorectal cancer|9 weeks +/- 2 weeks|The study was closed early due to lack of accrual. The data were not collected or analyzed.||||||
2663647|NCT01550367|Secondary|Conventional Dendritic Cells (cDC)|Percentage of Conventional Dendritic Cells (cDC) per ml of blood. cDC reside in tissues and once activated, migrate to draining lymph nodes to promote adaptive immune responses.|Up to 3 years|Patients that received study treatment for whom Conventional Dendritic Cells (cDC) were able to be measured.|||percentage of cells/mL||Full Range|Mean
2663649|NCT01550367|Secondary|Plasmacytoid Dendritic Cells (pDC)|Percentage of Plasmacytoid dendritic cells per ml of blood. In cancer, pDC are malignant immune cells that demonstrate an impaired response that can contribute to the establishment of an immunosuppressive tumor microenvironment.|Up to 3 years|Patients that received study treatment for whom Plasmacytoid dendritic Cells (pDC) were able to be measured.|||percentage of cells/mL||Full Range|Mean
2663650|NCT01550367|Secondary|Regulatory T Cells (Treg)|Percentage of Regulatory T cells per ml of blood. High levels of Tregs in the tumor microenvironment are associated with poor prognosis in many cancers by suppressing the body's anti-tumor immune response.|Up to 3 years|Patients that received study treatment for whom Regulatory T cells (Treg) were able to be measured.|||percentage of cells/mL||Full Range|Mean
2663651|NCT01550367|Secondary|Myeloid Derived Suppressor Cell (MDSC)|Percentage of Myeloid Derived Suppressor Cell per ml of blood. MDSC immune cells originate from bone marrow stem cells and strongly expand in cancer.|Up to 3 years|Patients that received study treatment for whom MDSC were able to be measured.|||percentage of cells/mL||Full Range|Mean
2663652|NCT01550367|Secondary|Natural Killer (NK) Cells|Percentage of Natural Killer (NK) cells per ml of blood. NK cells are lymphocytes with the ability to kill tumor cells without deliberate immunization or activation.|Up to 3 years|Patients that received study treatment for whom Natural Killer (NK) cells were able to be measured.|||percentage of cells||Full Range|Mean
2663653|NCT01550367|Secondary|Number of Participants With Low Karnofsky Performance Status|Karnofsky performance status is a standard way of measuring the ability of cancer patients to perform ordinary tasks. The Karnofsky Performance Status scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities. Karnofsky Performance Status may be used to determine a patient's prognosis, to measure changes in a patient's ability to function, or to decide if a patient should be included in the trial. A low Karnofsky performance status (<80%) is considered to be unfavorable.|Up to 3 years|Patient that received study treatment for whom Karnofsky performance status was able to be assessed.|||Participants|||Count of Participants
2663654|NCT01550367|Secondary|Prior Nephrectomy|Number of patients with history of a prior nephrectomy (surgical removal of a kidney) or no history of a prior nephrectomy.|Up to 3 years|Patients that received study treatment, with or without a history of nephrectomy (surgical removal of a kidney).|||Participants|||Count of Participants
2663655|NCT01550367|Secondary|Serum Calcium Levels (Corrected)|Number of patients with either normal or high serum calcium levels. High serum calcium levels are considered to be clinically unfavorable.|Up to 3 years|Patients that received study treatment for whom serum calcium levels were able to be measured from clinical samples and determined to be either normal or high.|||Participants|||Count of Participants
2663656|NCT01550367|Secondary|Hemoglobin Levels|Low hemoglobin levels (less than the lower limit of normal (13.2 g/dL)) are considered to be unfavorable.|Up to 3 years|Patient that received study treatment for whom hemoglobin levels were able to be measured from clinical samples and determined to be either normal or low.|||Participants|||Count of Participants
2663657|NCT01550367|Secondary|Serum Lactate Dehydrogenase|Number of participants with either high serum lactate dehydrogenase (> 1.5 times upper limit of normal) or normal lactate dehydrogenase.|Up to 2 years|Patients that received study treatment for whom LDH was able to be measured from clinical samples and determined to be either normal or high.|||Participants|||Count of Participants
2663658|NCT01550367|Secondary|Worst Grade of Adverse Event At Least Probably Related to Treatment Experienced|Number of participants who experienced Grade 2-5 adverse events that were at least probably related to study treatment.|Up to 3 years|Patients that received at least one dose of study treatment (IL-2 + either 1,200 HCQ or 600 mg/d HCQ).|||Participants|||Count of Participants
2663659|NCT01550367|Secondary|Worst Grade of Adverse Event At Least Possibly Related to Treatment Experienced|Number of participants who experienced Grade 2-5 adverse events that were at least possibly related to study treatment.|Up to 3 years|Patients that received at least one dose of study treatment (IL-2 + either 1,200 HCQ or 600 mg/d HCQ).|||Participants|||Count of Participants
2663660|NCT01550367|Secondary|Worst Grade of Adverse Event Experienced|Number of participants who experienced Grade 2-5 adverse events.|Up to 3 years|Patients that received at least one dose of study treatment (IL-2 + either 1,200 HCQ or 600 mg/d HCQ).|||Participants|||Count of Participants
2663661|NCT01550367|Secondary|Frequency of Grade III and Grade IV Toxicities|Number of specified categories of grade III and IV or unexpected or rare toxicities occurring during the first course (up until the end of cycle 1) of IL-2 treatment.|Up to 3 years|Patients that received at least one dose (cycle) of study treatment (IL-2 + either 1,200 HCQ or 600 mg/d HCQ) and experienced specified categories of toxicities.|||events|||Number
2663662|NCT01550367|Secondary|Number of Doses of IL-2 + HCQ|Number of doses of IL-2 administered during the first course of therapy.|Up to 3 years|Patients that received at least one dose of study treatment (IL-2 + either 1,200 HCQ or 600 mg/d HCQ).|||doses||95% Confidence Interval|Mean
2663663|NCT01550367|Secondary|Progression-free Survival (PFS)|Time from the date of first protocol treatment until the date disease progression criteria are met (in responding patients progression criteria uses the reference of the smallest measurements recorded since the treatment started) or is censored at date of last disease assessment for those who have not progressed. Per RECIST 1.1, Progressive Disease (PD) is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.|Up to 3 years|Patients with metastatic RCC treated with IL-2 combined with hydroxychloroquine (HCQ) at either 600 mg/d or 1,200 mg/d.|||months||95% Confidence Interval|Median
2663664|NCT01550367|Secondary|Overall Survival (OS)|Time from date of first protocol treatment until the date of death, or censored at date of last contact.|Up to 3 years|Patients with metastatic RCC treated with IL-2 combined with hydroxychloroquine (HCQ).|||months||95% Confidence Interval|Median
2663701|NCT01549977|Primary|Change From Baseline in Exercise Treadmill Testing (ETT) Duration at Week 12|The change between the duration of ETT at Week 12 relative to Baseline. ETTs were conducted using the modified Bruce Protocol. Participants exercised on a treadmill, starting at 1.7 mph and 0% incline. The intensity of exercise (speed and/or incline) was increased at 3 minute intervals.|Baseline and Week 12|This analysis was not performed since only one participant completed the study prior to study termination.||||||
2663665|NCT01550367|Primary|Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at 600 mg/d|Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.|Up to 3 years|Patients with metastatic RCC treated with IL-2 combined with hydroxychloroquine (HCQ) 600 mg/d who were evaluable for clinical response.|||Participants|||Count of Participants
2663666|NCT01550367|Primary|Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at 1,200 mg/d|Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.|Up to 3 years|Patients with metastatic RCC treated with IL-2 combined with hydroxychloroquine (HCQ) 1,200 mg/d who were evaluable for clinical response.|||Participants|||Count of Participants
2663667|NCT01550367|Primary|Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at Either 1,200 mg/d or 600 mg/d) (All Patients)|Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.|Up to 3 years|Patients with metastatic RCC treated with IL-2 combined with hydroxychloroquine (HCQ at either 1,200 mg/d or 600 mg/d) who were evaluable for clinical response. Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dosing was reduced to 600 mg/d.|||Participants|||Count of Participants
2663668|NCT01550302|Secondary|Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension||24 and 48 hours after the surgery|Hypotension data not collected|||Participants|||Count of Participants
2663669|NCT01550302|Secondary|Number of Participants Requiring Post-operative Ibuprofen as a Rescue Medication||48 hours after the surgery||||number of participants|||Number
2663670|NCT01550302|Secondary|Numeric Response Scale Pain Scores Around Chest Tube Insertion Site at Rest and During Coughing|Data collected on an interval scale ranging from 0 (no pain) to 10 (highest or most pain). Reported data shows an average of scores across participants|6, 12, 18, 24 and 48 hours after the surgery|Data not collected for 6, 12, and 18 hours at rest or with movement/cough|||units on a scale||Standard Deviation|Mean
2663671|NCT01550302|Secondary|Numeric Response Scale Pain Scores at Incision Site at Rest and During Coughing|Data collected on an interval scale ranging from 0 (no pain) to 10 (highest or most pain). Reported data shows an average of scores across participants|6, 12, 18, 24 and 48 hours after the surgery|Data not collected for 6, 12, and 18 hours at rest or moving/with cough|||units on a scale||Standard Deviation|Mean
2663672|NCT01550302|Secondary|Numeric Response Scale Pain Scores Around Ipsilateral Shoulder at Rest and During Movement|Data collected on an interval scale ranging from 0 (no pain) to 10 (highest or most pain). Reported data shows an average of scores across participants|6, 12, 18, 24 and 48 hours after the surgery|Data not collected for 6, 12, and 18 hours at rest or with movement/coughing|||units on a scale||Standard Deviation|Mean
2663673|NCT01550302|Secondary|Post-operative Opioid Consumption Expressed in Morphine Equivalents||24 hours after the surgery||||mg||Standard Deviation|Mean
2663674|NCT01550302|Primary|Incidence of Post-thoracotomy/Scopy Ipsilateral Shoulder Pain||24 hours after lung surgery||||Participants|||Count of Participants
2663675|NCT01550289|Secondary|Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers ratios were assessed in the Full Analysis Set with available data for each time point.|||Titer ratio||95% Confidence Interval|Geometric Mean
2663676|NCT01550289|Secondary|Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus Non-immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
2663721|NCT01549873|Primary|Amplitude Required to Elicit the MEP|Compare the data obtained from neuromonitoring including the amplitude required to elicit the MEP from patients receiving general anesthesia with an inhalational anesthetic agent to those receiving total intravenous anesthesia (TIVA).|at time of surgery||||milliamperes||Standard Deviation|Mean
2663677|NCT01550289|Secondary|Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers ratios were assessed in the Full Analysis Set with available data for each time point.|||Titer ratio||95% Confidence Interval|Geometric Mean
2663678|NCT01550289|Secondary|Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype In Flavivirus-Immune Participants Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
2663679|NCT01550289|Secondary|Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.|||Percentage of participants|||Number
2663680|NCT01550289|Secondary|Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Serotypes Before and After Each Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.|||Percentage of participants|||Number
2663681|NCT01550289|Secondary|Percentage of Flavivirus-non Immune Participants With Antibody Titer < 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) non-immune participants at baseline are defined as those participants with <10 (1/dil) for all serotypes with parental dengue virus strains and for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.|||Percentage of participants|||Number
2663682|NCT01550289|Secondary|Percentage of Flavivirus-Immune Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Serotype Before and After Each Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT). Flavivirus (FV) immune participants at baseline are defined as those participants with ≥10 (1/dil) for at least one serotype with the parental dengue virus strain or for Japanese encephalitis (JE) virus.|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.|||Percentage of participants|||Number
2663683|NCT01550289|Primary|Percentage of Participants With Solicited Injection-site and Systemic Reactions After Any and Each Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo|Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 Solicited Injection site reactions: Pain Significant; prevents daily activities; Erythema and Swelling >100 mm. Grade 3 Solicited systemic reactions: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Asthenia Significant; prevents daily activities.|Day 0 up to Day 14 post each injection|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set with available data for each time point.|||Percentage of participants|||Number
2663684|NCT01550289|Primary|Summary of Geometric Mean Titer Ratios of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titer ratios were assessed in the Full Analysis Set with available data for each time point.|||Titer ratio||95% Confidence Interval|Geometric Mean
2663685|NCT01550289|Primary|Summary of Geometric Mean Titers of Antibodies Against Each Dengue Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Geometric mean titers were assessed in the Full Analysis Set with available data for each time point.|||Titers (1/dilutions)||95% Confidence Interval|Geometric Mean
2663686|NCT01550289|Primary|Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against at Least 1, 2, 3, or 4 Dengue Virus Serotypes Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.|||Percentage of participants|||Number
2663687|NCT01550289|Primary|Percentage of Participants With Antibody Titer ≥ 10 1/Dil Against Each Dengue Virus Serotype Before and After Each Vaccination With Either Tetravalent Dengue Vaccine or a Placebo|Dengue neutralizing antibody levels were measured by dengue plaque reduction neutralization test (PRNT).|Pre-injection 1 and 28 days post each injection (up to 13 months post-injection 1)|Dengue neutralizing antibody titers were assessed in the Full Analysis Set with available data for each time point.|||Percentage of participants|||Number
2663689|NCT01550224|Secondary|Relapse-Free Survival (RFS) at 2 Years|"Relapse-free survival (RFS) is defined as survival after complete response (CR) or (PR) without further disease progression. RFS is reported as the percentage without dispersion of participants in Groups 1 and 2 that experienced CR or PR, and were alive without progression 2 years after induction chemotherapy. CR and PR are defined as the following.~CR = < 5% blasts in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods; no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL~PR = 5% to 25% blasts (must be ≥ 50% reduction of blasts) in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL"|2 years||||Participants|||Count of Participants
2663690|NCT01550224|Secondary|Disease-free Survival (DFS) at 2 Years|"Disease-Free Survival (DFS) is defined as survival after complete response (CR) without disease progression. DFS is reported as the percentage without dispersion of participants in Groups 1 and 2 that experienced CR and were alive without progression (ie, without disease) 2 years after induction chemotherapy. CR is defined as all of the following.~CR = < 5% blasts in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods; no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL"|2 years||||Participants|||Count of Participants
2663691|NCT01550224|Secondary|Treatment Failure (TF)|"Treatment failure (TF) is defined as failing to achieve either a complete remission (CR) or partial remission (PR) after induction chemotherapy. The outcome is reported as the percentage without dispersion of participants in Groups 1 and 2 that experienced TF. CR and PR are defined as the following.~CR = < 5% blasts in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods; no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL~PR = 5% to 25% blasts (must be ≥ 50% reduction of blasts) in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL"|up to 10 weeks||||Participants|||Count of Participants
2663692|NCT01550224|Secondary|Partial Remission (PR)|"Partial remission (PR) is reported as the percentage without dispersion of participants in Groups 1 and 2 that demonstrated PR. PR is defined as all of the following.~PR = 5% to 25% blasts (must be ≥ 50% reduction of blasts) in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL"|up to 10 weeks||||Participants|||Count of Participants
2663693|NCT01550224|Secondary|Cytogenetic Response (CyR)|"Cytogenetic response (CyR) is defined as complete remission (CR), PLUS a documented decrease or absence of cytogenetic abnormalities, when analyzed microscopically for 20 cellular metaphases (actively dividing cells). The outcome is reported as the percentage without dispersion of participants in Groups 1 and 2 that demonstrated CyR. CR is defined as all of the following.~CR = < 5% blasts in bone marrow aspirate containing marrow spicules; > 200 nucleated cells no blasts with Auer rods; no persistence of extramedullary disease absolute neutrophil count (ANC) ≥ 1,000/µL platelets (PLT) ≥ 100,000/µL"|up to 10 weeks||||Participants|||Count of Participants
2663694|NCT01550224|Secondary|Complete Remission With Incomplete Blood Count Recovery (CRp)|"The rate of complete remission with incomplete blood count recovery (CRp) for Groups 1 and 2 was assessed as the rate of morphologic leukemia-free state (MLFS) but with EITHER residual neutropenia (ANC < 1,000/µL) OR residual thrombocytopenia (PLT < 100,000/µL). MLFS is defined as follows.~MLFS = < 5% blasts in bone marrow aspirate containing marrow spicules > 200 nucleated cells no blasts with Auer rods no persistence of extramedullary disease"|up to 10 weeks||||Participants|||Count of Participants
2663695|NCT01550224|Secondary|Morphologic Leukemia-free State (MLFS)|"The rate of morphologic leukemia-free state (MLFS) is reported as the percentage without dispersion of participants in Groups 1 and 2 that achieve MLFS. The outcome is reported as the percentage without dispersion of participants in Groups 1 and 2 that demonstrated MLFS. This assessment is independent of absolute neutrophil count (ANC) or platelets (PLT) recovery status. MLFS is defined below.~MLFS = < 5% blasts in bone marrow aspirate containing marrow spicules > 200 nucleated cells no blasts with Auer rods no persistence of extramedullary disease"|up to 10 weeks||||Participants|||Count of Participants
2663696|NCT01550224|Primary|Complete Remission (CR)|"This study evaluates the clinical efficacy of temozolomide + vorinostat as administered to Groups 1 and 2, assessed as the rate of complete remission [CR, aka morphologic complete remission (mCR)], defined as the morphologic leukemia-free state (MLFS), WITH absolute neutrophil count (ANC) ≥ 1,000/µL AND platelets (PLT) ≥ 100,000/µL. The outcome is reported as the percentage without dispersion of participants in Groups 1 and 2 that demonstrated CR. CR is defined as all of the following.~MLFS = < 5% blasts in bone marrow aspirate containing marrow spicules > 200 nucleated cells no blasts with Auer rods no persistence of extramedullary disease ANC = ≥ 1,000/µL PLT = ≥ 100,000/µL"|up to 10 weeks||||Participants|||Count of Participants
2663697|NCT01549977|Secondary|Percentage of Participants Stopping ETT Due to Angina at Week 12|The percentage of participants who had to stop exercise treatment testing (ETT) due to experiencing angina symptoms at Week 12.|Week 12|This analysis was not performed since only one participant completed the study prior to study termination.||||||
2663698|NCT01549977|Secondary|Change From Baseline in Maximum ST-segment Depression During ETT at Week 12|The change between the maximum ST-segment depression during ETT at Week 12 relative to Baseline. ST-segment is measured by electrocardiography (ECG) and represents the interval between ventricular depolarization and repolarization.|Baseline and Week 12|This analysis was not performed since only one participant completed the study prior to study termination.||||||
2663699|NCT01549977|Secondary|Change From Baseline in Time to Onset of ≥1 mm ST-segment Depression During ETT at Week 12|The change between the time to onset of ≥1 mm ST-segment depression during exercise treadmill test (ETT) at Week 12 relative to Baseline. ST-segment is measured by electrocardiography (ECG) and represents the interval between ventricular depolarization and repolarization.|Baseline and Week 12|This analysis was not performed since only one participant completed the study prior to study termination.||||||
2663700|NCT01549977|Secondary|Change From Baseline in Time to Onset of Angina During ETT at Week 12|The change between the time to onset of angina during the exercise treadmill test (ETT) at Week 12 relative to Baseline.|Baseline and Week 12|This analysis was not performed since only one participant completed the study prior to study termination.||||||
2663702|NCT01549964|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|The change between FPG collected at week 24 relative to Baseline. A MMRM model was used for analysis with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure.|Baseline and Week 24|Full Analysis Set included all randomized participants who received at least 1 dose of study drug analyzed according to the treatment group to which they were randomized. A participant was included in the analyses when there was both a Baseline and at least 1 Post-baseline value at Week 24.|||mg/dL||Standard Error|Least Squares Mean
2663703|NCT01549964|Secondary|Incidence of HbA1c <7%|Incidence (percentage) of participants with glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than 7% at Week 24.|24 Weeks|Full Analysis Set included all randomized participants who received at least 1 dose of study drug analyzed according to the treatment group to which they were randomized|||percentage of participants|||Number
2663704|NCT01549964|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to Baseline. A Mixed Model Repeated Measures (MMRM) model was used for analysis with treatment, country, schedule, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure.|Baseline and Week 24|Full Analysis Set included all randomized participants who received at least 1 dose of study drug analyzed according to the treatment group to which they were randomized. A participant was included in the analyses when there was both a Baseline and at least 1 Post-baseline value at Week 24.|||Percent||Standard Error|Least Squares Mean
2663705|NCT01549951|Secondary|Number of Participants Reporting Clinically Significant Abnormalities in ECG|The number of participants who reported clinically significant abnormalities in ECG were measured throughout study. ECGs were performed after the participant had been supine for at least 10 minutes.|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
2663706|NCT01549951|Secondary|Number of Participants Reporting Clinically Significant Abnormalities in Physical Findings|Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10).|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
2663707|NCT01549951|Secondary|Number of Participants Reporting Clinically Significant Abnormalities in Vital Signs|The number of participants with any clinically significant abnormalities in vital signs collected throughout study. Vital signs included body temperature (oral), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
2663708|NCT01549951|Secondary|Number of Participants Reporting Clinically Significant Abnormalities in Laboratory Values|The number of participants with any clinically significant abnormalities in safety laboratory values collected throughout study.|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
2663709|NCT01549951|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 30 days after last dose of study drug (Day 86)|Safety analysis set was defined as all participants who received at least 1 dose of any study drug.|||participants|||Number
2663710|NCT01549951|Secondary|Cmax: Maximum Observed Plasma Concentration for Orteronel and M-I Metabolite|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|PK population was defined as all participants who had sufficient dosing data and plasma concentration-time data to permit calculations of PK parameters.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2663711|NCT01549951|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Orteronel and M-I Metabolite|Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|PK population was defined as all participants who had sufficient dosing data and plasma concentration-time data to permit calculations of PK parameters.|||hours||Full Range|Median
2663720|NCT01549873|Secondary|Amplitude of the SSEPs|SSEPs (somatosensory evoked potentials) are most commonly elicited by bipolar transcutaneous electrical stimulation applied on the skin over the trajectory of peripheral nerves of the upper limb (e.g., the median nerve) or lower limb (e.g., the posterior tibial nerve), and then recorded from the scalp. The amplitude is the voltage of the electrical stimulation recorded.|day of surgery||||microvolt||Standard Deviation|Mean
2668507|NCT01505673|Secondary|Pancreatic and Hepatic Triglyceride Content|Liver Triglyceride and Pancreatic Triglyceride|6-months||||Percent Triglyceride||Standard Deviation|Mean
2663712|NCT01549951|Secondary|AUC(0-6): Area Under the Plasma Concentration-Time Curve From Time 0 to 6 Hours Postdose for Orteronel and M-I Metabolite|AUC(0-6) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval - 6 hours in this study). Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|Pharmacokinetic (PK) population was defined as all participants who had sufficient dosing data and plasma concentration-time data to permit calculations of PK parameters.|||nanogram hours per milliliter (ng*hr/mL)||Standard Deviation|Mean
2663713|NCT01549951|Secondary|Correlation Between the QTcF Change From Baseline and Plasma Concentrations of Orteronel|Coefficient of correlation was measured using linear mixed effects model for the association between two variables; change from baseline versus the plasma concentration. Participant's effects on the intercept and plasma concentration slope were included in the model as random effects terms. Plasma concentrations were re scaled for model convergence. Average results at each time point were analyzed and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.|||correlation coefficient||Standard Error|Least Squares Mean
2663714|NCT01549951|Secondary|Number of Participants Reporting Change From Baseline in ECG Morphology|Participants with incidence of ECG morphology abnormalities were observed. Types of abnormalities included appearance of abnormal U waves, T waves inversion, elevation of ST segment, depression of ST segment, second or third degree heart block, right or left bundle branch block, atrial fibrillation/flutter, and myocardial infarction. New morphological changes were observed in abnormal U waves, depression of ST segment, and T waves inversion. Here, 'new' refers to change not present at baseline, ie, at any evaluation predose, and only seen postbaseline. Results of change in ECG morphology analyzed from 12-lead ECGs at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.|||participant|||Number
2663715|NCT01549951|Secondary|Changes From Baseline in Heart Rate|Triplicate 12-lead Electrocardiogram (ECG) measurements were performed and average was calculated. Supine heart rate was measured as beats per minute (bpm). Results of change in heart rate analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.|||bpm||Standard Deviation|Mean
2663716|NCT01549951|Secondary|Maximum Change From Baseline in QTc Based on the Bazett Correction (QTcB) Method, PR, QRS and Uncorrected QT Interval|Triplicate 12-lead ECG measurements (each recording separated by approximately 1 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Bazette's formula (QTcB = QT divided by square root of RR). Results of change in QTcB, PR, QRS and uncorrected QT analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.|||msec||Standard Deviation|Mean
2663717|NCT01549951|Primary|Maximum Change From Baseline in QTc Interval Based on the Fridericia Correction (QTcF) Method|Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 1 minute) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR). Results of change in QTcF analyzed from 12-lead ECGs performed at each time point were averaged for analysis and a maximum across all post-dosing time points was used. Baseline is defined as the average of the triplicate 12-lead ECG measurements taken at the specified time prior to dosing.|Cycle 1 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose; Cycle 2 (28 day cycle), Day 1: pre-dose and at multiple timepoints (up to 6 hours) post-dose|ECG analysis population was defined as all participants with at least 1 available baseline and at least 1 on-treatment ECG who received at least 1 dose of any study drug.|||millisecond (msec)||Standard Deviation|Mean
2663718|NCT01549925|Primary|Surgical Time|To evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical ligatures|at time of surgery, up to 10 minutes||||SECONDS||95% Confidence Interval|Mean
2663719|NCT01549873|Secondary|Latency of the SSEP's|SSEPs (somatosensory evoked potentials) are most commonly elicited by bipolar transcutaneous electrical stimulation applied on the skin over the trajectory of peripheral nerves of the upper limb (e.g., the median nerve) or lower limb (e.g., the posterior tibial nerve), and then recorded from the scalp. Latency is the time interval between the stimulation and response.|day of surgery||||milliseconds||Standard Deviation|Mean
2668508|NCT01505673|Primary|Glycemic Control Measured by HbA1c|HbA1c (%)|6-months||||Percent HbA1c||Standard Deviation|Mean
2663722|NCT01549860|Secondary|Change in Pain VAS Scores|"Compare VAS Pain Scores between arms at baseline and 4 weeks post randomization~Subjects indicate their pain level by drawing a mark on a 10 cm line on a visual analog scale (VAS) at randomization and 4 week post treatment visit. The left end of the line indicates no pain and the right end of line indicates worst pain imaginable. VAS score is determined by using a ruler placed at 0 (left end of scale) and measuring the distance from zero to the patient's mark . The objective is to compare the change in VAS values in MIST+SC to SC alone.~H0: The average change in pain level is not different between MIST and SC HA: The average change in pain level is different between MIST and SC H0: µMIST = µSC vs HA: µMIST ≠ µSC,~Statistical Analysis. A repeated measures ANCOVA will be used to test for differences in change in VAS with an indicator variable to indicate treatment, any demographic variables which were significant in the baseline comparisons."|Baseline, 2 weeks and 4 weeks post randomization|Eligible Subjects Randomized|||VAS pain level measured in centimeters||Full Range|Median
2663723|NCT01549860|Secondary|Heal Rates|Compare rate of wound closure between study arms for 12 weeks post randomization. Descriptive statistics as not a powered endpoint.|12 weeks post randomization|Eligible subjects randomized|||participants|||Number
2663724|NCT01549860|Primary|Wound Area Mean Percent Reduction|"Compare between the treatment groups percent wound area reduction at four weeks of study treatment.~H0: µMIST+SC -- µSC = 0 HA: µMIST+SC -- µSC ≠ 0 Where µ = percent reduction in wound size."|4 weeks post baseline visit (randomization visit)|eligible subjects that were randomized|||percentage of mean area reduction||Standard Deviation|Mean
2663725|NCT01549652|Secondary|Change in Roland-Morris Disability (RMDI) Index From Baseline (Prevention of Physical Dependence)|The Roland-Morris Disability Index is a 24-question instrument used to assess level of disability from lower back pain. Scores range from 0-24 with lower scores corresponding to fewer symptoms. Change is from baseline score (taken at the beginning of the first study visit, prior to beginning of titration into morphine) to the score taken after taking morphine for 30 days (score taken at the beginning of second study visit).|2 study days 1 month apart (at the start of each study visit)|Participants in the Prevention of Physical Dependence Arm were analyzed.|||units on a scale||Standard Deviation|Mean
2663726|NCT01549652|Secondary|Change in Pain Visual Analog Scale (VAS) From Baseline (Prevention of Physical Dependence)|The VAS is a 0 to 100 millimeter scale where 0 corresponds to no pain and 100 to extreme pain, used by participants to indicated their level of pain over the last two weeks. Change is from baseline score for average level of pain (taken at the beginning of the first study visit, prior to beginning of titration into morphine) to the score taken after taking morphine for 30 days (score taken at the beginning of second study visit).|2 study days 1 month apart (at the start of each study visit)|Participants in the Prevention of Physical Dependence Arm were analyzed.|||units on a scale||Standard Deviation|Mean
2663727|NCT01549652|Secondary|Profile of Mood States (POMS) Change in Score From Baseline (Prevention of Physical Dependence)|(Profile of Mood States) POMS is a 65-question survey of how participants have been feeling over the past week, assessing tension, depression, anger, fatigue, confusion and vigor. Each question is on a 5-point scale: 0 (not at all) to 4 (extremely). Overall score range: 0 to 200 (lower scores corresponding to fewer symptoms), calculated by adding total scores for tension, depression, anger, fatigue and confusing, and subtracting that total score from the total score for vigor. Immediately prior to ondansetron or placebo administration a baseline POMS score was taken. 30 minutes later participants received naloxone, then 15 minutes later a POMS score was taken. If necessary (as deemed by the clinician), participants may have received a second naloxone dose (25 minutes following 1st naloxone dose), then 15 minutes later an POMS score was taken. Change from the baseline POMS score to the score assessed following the last naloxone dose is reported.|Baseline; 15 minutes following last naloxone dose|Participants in the Prevention of Physical Dependence Arm were analyzed.|||units on a scale||Standard Deviation|Mean
2663728|NCT01549652|Secondary|Beck Depression Inventory Score (BDIS) Change From Baseline (Prevention of Physical Dependence)|The Beck Depression Inventory (a 21-item self-report multiple-choice inventory) yields a single summed score between 0 and 63; higher scores indicate more severe depression. Change is from baseline score (taken at the beginning of the first study visit, prior to beginning of titration into morphine) to the score taken after taking morphine for 30 days (score taken at the beginning of second study visit).|2 study days 1 month apart (at the start of each study visit)|Participants in the Prevention of Physical Dependence Arm were analyzed.|||units on a scale||Standard Deviation|Mean
2663729|NCT01549652|Secondary|Change in Subjective Opioid Withdrawal Score From Baseline (Prevention of Physical Dependence)|The SOWS score is composed of 16 subjective symptoms rated on a scale of 0 to 4 (0=not at all, 4=extremely) based on what subjects were experiencing at the time of testing. A maximum score of 64 would suggest the patient is experiencing the symptoms of withdrawal to the maximum extent possible while the lowest score of 0 would suggest the patient is not experiencing any of the symptoms of withdrawal. Immediately prior to ondansetron or placebo administration a baseline SOWS score was taken. 30 minutes later participants received naloxone, then 15 minutes later an SOWS score was taken. If necessary (as deemed by the clinician), participants may have received a second naloxone dose (25 minutes following 1st naloxone dose), then 15 minutes later an SOWS score was taken. Change from the baseline SOWS score to the score assessed following the last naloxone dose is reported|Baseline; 15 minutes following last naloxone dose|Participants in the Prevention of Physical Dependence Arm were analyzed.|||units on a scale||Standard Deviation|Mean
2663730|NCT01549652|Primary|Change in Objective Opioid Withdrawal Score From Baseline (Prevention of Physical Dependence)|"Originally developed by Handelsman, the OOWS score is a well-characterized measure of opioid withdrawal in humans, calculated as the sum of a 13-item physician assessment documenting physically observable signs of withdrawal, which are rated as present (1) or absent (0) during the observation period. The maximum score is 13 and suggests the patient is showing all signs of opioid withdrawal to the largest extent possible. The minimum score of 0 suggests the patient is not showing any signs of opioid withdrawal.~Immediately prior to ondansetron or placebo administration a baseline OOWS score was taken. 30 minutes later participants received naloxone, then 15 minutes later an OOWS score was taken. If necessary (as deemed by the clinician), participants may have received a second naloxone dose (25 minutes following 1st naloxone dose), then 15 minutes later an OOWS score was taken. Change from the baseline OOWS score to the score assessed following the last naloxone dose is reported."|Baseline; 15 minutes following last naloxone dose|Participants in the Prevention of Physical Dependence Arm were analyzed.|||units on a scale||Standard Deviation|Mean
2663731|NCT01549652|Secondary|Change in Roland-Morris Disability Index (RMDI) From Baseline (Prevention of Opioid Withdrawal)|The Roland-Morris Disability Index is a 24-question instrument used to assess level of disability from lower back pain. Scores range from 0-24 with lower scores corresponding to fewer symptoms. Change is from baseline score (taken at the beginning of the first study visit, prior to beginning of titration into morphine) to the score taken after taking morphine for 30 days (score taken prior to receiving ondansetron or placebo, at the beginning of second study visit).|2 study days 1 month apart (at the start of each study visit)|Participants in the Prevention of Opioid Withdrawal Arm were analyzed.|||units on a scale||Standard Deviation|Mean
2663732|NCT01549652|Secondary|Change in Pain Visual Analog Scale (VAS) From Baseline (Prevention of Opioid Withdrawal)|The VAS is a 0 to 100 millimeter scale where 0 corresponds to no pain and 100 to extreme pain, used by participants to indicated their level of pain over the last two weeks. Change is from baseline score for average level of pain (taken at the beginning of the first study visit, prior to beginning of titration into morphine) to the score taken after taking morphine for 30 days (score taken prior to receiving ondansetron or placebo, at the beginning of second study visit).|2 study days 1 month apart (at the start of each study visit)|Participants in the Prevention of Opioid Withdrawal Arm were analyzed.|||units on a scale||Standard Deviation|Mean
2663733|NCT01549652|Secondary|Profile of Mood States (POMS) Change in Score From Baseline (Prevention of Opioid Withdrawal)|Profile of Mood States (POMS) is a 65-question survey of how participants have been feeling over the past week, assessing tension, depression, anger, fatigue, confusion and vigor. Each question is on a 5-point scale: 0 (not at all) to 4 (extremely). Overall score range: 0 to 200 (lower scores corresponding to fewer symptoms), calculated by adding total scores for tension, depression, anger, fatigue and confusing, and subtracting that total score from the total score for vigor. Immediately prior to ondansetron or placebo administration a baseline POMS score was taken. 30 minutes later participants received naloxone, then 15 minutes later a POMS score was taken. If necessary (as deemed by the clinician), participants may have received a second naloxone dose (25 minutes following 1st naloxone dose), then 15 minutes later an POMS score was taken. Change from the baseline POMS score to the score assessed following the last naloxone dose is reported.|Baseline; 15 minutes following last naloxone dose|Participants in the Prevention of Opioid Withdrawal Arm were analyzed.|||units on a scale||Standard Deviation|Mean
2663734|NCT01549652|Secondary|Beck Depression Inventory Score (BDIS) Change From Baseline (Prevention of Opioid Withdrawal)|The Beck Depression Inventory (a 21-item self-report multiple-choice inventory) yields a single summed score between 0 and 63; higher scores indicate more severe depression. Change is from baseline score (taken at the beginning of the first study visit, prior to beginning of titration into morphine) to the score taken after taking morphine for 30 days (score taken prior to receiving ondansetron or placebo, at the beginning of second study visit).|2 study days 1 month apart (at the start of each study visit)|Participants in the Prevention of Opioid Withdrawal Arm were analyzed.|||units on a scale||Standard Deviation|Mean
2663735|NCT01549652|Secondary|Change in Subjective Opioid Withdrawal Score (SOWS) From Baseline (Prevention of Opioid Withdrawal)|The Subjective Opioid Withdrawal Score (SOWS) score is calculated as the sum of 16 subjective patient-reported symptom scores rated on a scale of 0 to 4 (0=not at all, 4=extremely) based on what subjects were experiencing at the time of testing. A maximum score of 64 would suggest the patient is experiencing the symptoms of withdrawal to the maximum extent possible while the lowest score of 0 would suggest the patient is not experiencing any of the symptoms of withdrawal. Immediately prior to ondansetron or placebo administration a baseline SOWS score was taken. 30 minutes later participants received naloxone, then 15 minutes later an SOWS score was taken. If necessary (as deemed by the clinician), participants may have received a second naloxone dose (25 minutes following 1st naloxone dose), then 15 minutes later an SOWS score was taken. Change from the baseline SOWS score to the score assessed following the last naloxone dose is reported|Baseline; 15 minutes following last naloxone dose|Participants in the Prevention of Opioid Withdrawal Arm were analyzed.|||units on a scale||Standard Deviation|Mean
2663736|NCT01549652|Primary|Change in Objective Opioid Withdrawal Score (OOWS) From Baseline (Prevention of Opioid Withdrawal)|"Originally developed by Handelsman, the Objective Opioid Withdrawal Scale (OOWS) score is a well-characterized measure of opioid withdrawal in humans, calculated as the sum of a 13-item physician assessment documenting physically observable signs of withdrawal, which are rated as present (1) or absent (0) during the observation period. The minimum score of 0 means the patient is not showing any signs of opioid withdrawal. The maximum score of 13 signifies all signs of opioid withdrawal to the largest extent possible.~Immediately prior to ondansetron or placebo administration a baseline OOWS score was taken. 30 minutes later participants received naloxone, then 15 minutes later an OOWS score was taken. If deemed necessary by the clinician, participants may have received a second naloxone dose (25 minutes following 1st naloxone dose), then 15 minutes later an OOWS score was taken. Change from the baseline OOWS score to the score assessed following the last naloxone dose is reported."|Baseline; 15 minutes following last naloxone dose|Participants in the Prevention of Opioid Withdrawal Arm were analyzed.|||units on a scale||Standard Deviation|Mean
2663737|NCT01549613|Secondary|Digital and Infrared Imaging|Change in lesion area and temperature|Time frame begins on admission to RDTC for cellulitis and measurements will be taken every 2hour times 2 and every 4 hours until discharge from the RDTC.|||||||
2663738|NCT01549613|Primary|Satisfaction of Discharge Criteria|RDTC cellulitis protocol discharge criteria|Time point at which outcome measure is assessed 30 days from the date of admission.||||participants|||Number
2663739|NCT01549405|Primary|Total Consumption of Tramadol Will be Measured for the First 24 Hours||Postoperative 24th hour||||mg||Standard Deviation|Mean
2663740|NCT01549405|Secondary|Postoperative Pain Will be Evaluated.|"The pain score (VAS)(visual analog scale) will be evaluated for the first 24 hours.(0 no pain, to 10, the maximum pain )Pain score less then 4 is acceptable."|24 hours||||units on a scale||Inter-Quartile Range|Median
2663741|NCT01549405|Primary|Postoperative Analgesic (Tramadol) Consumption|Total consumption of tramadol will be measured for the first 24 hours.|Postoperative 24th hour|||||||
2663742|NCT01549392|Primary|3 Month Response|participants who had reduction of tumor size from avastin at 3 months|at 3 months after initial DECT and MR spectroscopy||||participants who had tumor reduction|||Number
2665081|NCT01536405|Secondary|Percentage of Participants With Zoster-like Rash||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data|||Percentage of participants|||Number
2663743|NCT01549340|Secondary|Duration of SCIT or SLIT Treatment for Participants With AR and Asthma or AR Alone|The mean duration in years of SCIT or SLIT treatment for all participants with AR and asthma and for all participants with AR only was calculated. Duration of SCIT or SLIT treatment was based on dates when allergy extract prescriptions were refilled.|Up to 5 years|The analysis population consisted of those participants with AR and asthma or AR alone who were advised by their physician to receive AIT to treat their AR and who initiated AIT.|||years||Standard Deviation|Mean
2663744|NCT01549340|Secondary|Percentage of Participants With a Co-morbidity of Asthma Who Initiated SCIT or SLIT|The percentage of participants who had AR and asthma and initiated SCIT or SLIT was calculated.|Up to 5 years|The analysis population consisted of those participants with AR and asthma who were advised by their physician to receive AIT to treat their AR and who initiated SCIT or SLIT.|||percentage of participants|||Number
2663745|NCT01549340|Primary|Reason for Discontinuation of SCIT or SLIT More Than 6 Months Before Completion of the Recommended Course|The reason for discontinuation of SCIT or SLIT treatment more than 6 months before completion of the recommended course of therapy was recorded. The percentage of participants whose records were reveiwed and who discontinued SCIT or SLIT due to different reasons was calculated.|Up to 5 years|The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR, who initiated and subsequently discontinued AIT, and had their charts reviewed for the reason for discontinuation.|||percentage of participants|||Number
2663746|NCT01549340|Primary|Duration of Treatment With SCIT or SLIT|The mean duration in years of SCIT or SLIT treatment for all participants with AR who initiated SCIT or SLIT was calculated. Duration of SCIT or SLIT was based on dates when allergy extract prescriptions were refilled.|Up to 5 years|The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR and who initiated AIT.|||years||Standard Deviation|Mean
2663747|NCT01549340|Primary|Percentage of Participants Who Initiated SCIT or SLIT and Completed 5 Years of Treatment|The percentage of participants who initiated SCIT or SLIT and completed 5 years of treatment was calculated. Duration of SCIT or SLIT was based on dates when allergy extract prescriptions were refilled. If extract refills continued past the recommended time for therapy (e.g. 5 years from the start of therapy), the participant was deemed successful in completing the recommended course. If the extract refills stopped prior to the end of the recommended time for therapy, but the last refill occurred within 6 months of the recommended time for therapy, this participant was deemed successful in completing the recommended course.|At 5 years|The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR and who initiated AIT.|||percentage of participants|||Number
2663748|NCT01549340|Primary|Percentage of Participants Advised to Start AIT Who Elected Subcutaneous Immunotherapy (SCIT) Shots or Sublingual Immunotherapy (SLIT) Drops|The percentage of participants who were advised by their physician to start AIT and elected to initiate AIT was calculated. AIT initiation was broken down by type of AIT initiated (SCIT or SLIT).|Up to 5 years|The analysis population consisted of those participants with AR who were advised by their physician to receive AIT to treat their AR.|||percentage of participants|||Number
2663749|NCT01549314|Secondary|Bone Turnover Markers|Change in osteocalcin|Baseline and 24 months|Subjects who were lost to follow up prior to the 24 month visit were not included in the analyses|||ng/ml||Standard Deviation|Mean
2663750|NCT01549314|Secondary|Areal Bone Mineral Density as Measured by DXA|Change in PA spine bone mineral density|Baseline and 24 months|Subjects who were lost to follow up prior to the 24 month visit were not included in the analyses|||g/cm2||Standard Deviation|Mean
2663751|NCT01549314|Primary|Bone Microarchitecture and Strength Measures of the Radius and Tibia|Change in cortical volumetric bone mineral density at the radius|Baseline and 24 months|Subjects who were lost to follow up prior to the 24 month visit were not included in the analyses|||mgHA/cm3||Standard Deviation|Mean
2663752|NCT01549275|Secondary|Correlation Between the Growth Speeds of Cultured Cells and Worsening of AJCC TNM Stages or HCC Related Death 6 Months After Plating of Cells|104 Patients with complete follow-up data were further divided into receiving (1) curative treatment of HCC including operative resection and local ablation therapy, (2) palliative transcatheter arterial chemoembolization (TACE), and (3) supportive treatment.|6 months after plating of cells|Correlation between the growth speeds of cultured cells and worsening of AJCC TNM stages or HCC related death 6 months after plating of cells|||participants|||Number
2663753|NCT01549275|Primary|Correlation Between the Growth Speeds of the Cultured Cells and the AJCC TNM Stage (7th Eds) at Entering of the Study.|Patients were divided into AJCC TNM staging < = IIIA and > = IIIB two groups. The incidences of patients with rapidly proliferative cultured cells in these two groups were compared. Rapidly proliferative group was defined as (1) growth area of cultured cells at the 28th day of primary culture exceeded two times of the growth area measured at the 14th day, or (2) growth area of cultured cells at the 28th day reached > 70% growth area of the flask. Based on the results from special stain, patients in rapidly proliferative group were further divided into patients with rapid proliferation of HCC cells alone, rapid proliferation of HCC cells with concomitant cancer-associated fibroblasts (CAFs) (HCC + CAFs) and CAFs alone.|28 days after plating of cells|Comparison the incidence of patients with rapidly proliferative cultured cells between two groups|||participants|||Number
2663754|NCT01549223|Secondary|Side Effects (Hypotension, Flushing, Nausea and Emesis) Associated With Uterotonic Drug Use|Number of subjects experiencing hypotension, flushing, nausea, and emesis reported after administration of uterotonic agents.|Up to 15 min from time of infant delivery|All side effects: hypotension, flushing, nausea and emesis|||Participants|||Count of Participants
2663755|NCT01549223|Primary|1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone.|Will measure total amount of oxytocin to achieve satisfactory uterine tone, as determined by the operating obstetrician.|Up to 15 min from time of infant delivery||||IU||Standard Deviation|Mean
2663756|NCT01549041|Secondary|Change in Brief Psychiatric Rating Scale (BPRS) Total Score|The BPRS will be completed by the Principle Investigator at baseline and at day 14. The BPRS has 18 items each rated 1-7 with 1 representing the lowest severity of symptoms and 7 representing the highest severity; thus the lowest and highest possible total scores are 18 and 126|From baseline to day 14||||units on a scale||Standard Error|Mean
2668585|NCT01504997|Secondary|Incidence of Adverse Events||Participants will be followed for the duration of hospital stay, an expected average of 10 days|||||||
2663758|NCT01549002|Secondary|Number of Patients Satisfied With Analgesia Administered|"Number of patients satisfied with analgesia administered will be evaluated by determining the number of patients who report a Likert scale response of somewhat satisfied, very satisfied, or extremely satisfied (i.e. any patient who selects any of these three responses will be considered to have been satisfied with analgesia administered). Patients will be asked 10 minutes after procedure completion. If the patient is 8 years of age and older, both the patient and the parent or guardian will complete a satisfaction survey. If the patients is younger than 8 years, their parent or guardian will complete the satisfaction survey."|10 minutes after procedure completion|Patient satisfied with analgesia administered|||Participants|||Count of Participants
2663759|NCT01549002|Secondary|Score on the Faces Pain Scale Revised (FPS-R)|"The Faces Pain Scale - Revised (FPS-R) is a self-report measure of pain has strong validity and reliability in children 4 - 17 years of age undergoing painful procedures, and will be used to assess patients' self reported pain. A score of 0 means no pain, a score of 10 means very much pain. Therefore, a lower score indicates that a patient is experiencing a lower degree of pain intensity.~Patients will complete the FPS-R at four times during their medical encounter: (1) before analgesia administration, (2) ten minutes after analgesia administration but before beginning I&D, (3) immediately post I&D procedure (to ascertain the pain perceived during procedure), and (4) ten minutes after procedure completion."|Up to 10 minutes after procedure completion|(1) before analgesia administration, (2) ten minutes after analgesia administration but before beginning I&D, (3) immediately post I&D procedure (to ascertain the pain perceived during procedure), and (4) ten minutes after procedure completion.|||units on a scale||Inter-Quartile Range|Median
2663760|NCT01549002|Primary|Score on the Observational Scale of Behavioral Distress Revised (OSBD-R)|Our primary outcome is the Observational Scale of Behavioral Distress - Revised (OSBD-R) to assess observed intra-procedural pain. The total OSBD-R score is a summation of the OSBD-R score of each individual phase. The score in each phase can range from 0 to 23.5. There were four phases in our study, so the range of scores for the total OSBD-R was 0 to 94, with a higher score indicating a greater degree of pain and distress. The four phases in the study are (1) before analgesia administration, (2) ten minutes after analgesia administration but before beginning I&D, (3) immediately post I&D procedure (to ascertain the pain perceived during procedure), and (4) ten minutes after procedure completion. The scores documented here are the total OSBD-R scores.|Up to 10 minutes after the procedure completion||||units on a scale||Standard Deviation|Mean
2663761|NCT01548885|Secondary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL)|"Using fresh and glycolyzed samples with Blood Glucose(BG) below 70 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)| / (BG Reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all five BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value . Higher MARD value indicates larger difference between meter value and the reference value."|10 hours|Same number (190) of BG results was possible for each BGMS. Subjects provided 1,2,or 3 capillary samples, of which 190 samples were less than 70 mg/dL.|||percentage|Participants|95% Confidence Interval|Mean
2663762|NCT01548885|Primary|MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range|"Using the overall Blood Glucose(BG) range (24 to 386mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD is calculated from the sum of all |(BG meter)-(BG reference)| / (BG Reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all five BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value . Higher MARD value indicates larger difference between meter value and the reference value."|10 hours|Same number 388(393-3-2)BG results possible for each BGMS.Subjects provided 1,2,or 3 capillary samples-total 393 samples. 3 glycolyzed samples were not analyzed - glycolysis exceeded the protocol-defined time. All meter data for 2 glycolyzed samples were not evaluable (not analyzed)- their YSI results were less than the meter operating ranges.|||percentage|Participants|95% Confidence Interval|Mean
2663763|NCT01548833|Primary|Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT)|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time.|Day 7, 16 hours after lens insertion||||seconds||Standard Deviation|Mean
2663764|NCT01548742|Other Pre-specified|Clinically Significant Improvement in Clinician Administered PTSD Scale (CAPS)|% of participants with clinically significant improvement in interviewer-rated PTSD symptom severity defined as a reduction of 10 points or more on the CAPS.|Weeks 9 and 17|Intent to treat analysis|||percentage clinical responders||95% Confidence Interval|Number
2663765|NCT01548742|Secondary|Depression Symptom Severity on the Patient Health Questionnaire-9 (PHQ-9) at Baseline, After Treatment, and at 2-Month Follow-up|The PHQ-9 is a valid and reliable measure of depression symptom severity. Score range from 0-27; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 5 or more points on the PHQ-9.|Baseline, Weeks 9 and 17|Intent to treat population (all participants randomized to treatment).|||units on a scale||95% Confidence Interval|Mean
2663766|NCT01548742|Secondary|PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up|The CAPS is a valid and reliable measure of PTSD symptom severity. Score range from 0-136; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 10 or more points on the CAPS.|Baseline, Weeks 9 and 17|Intent to treat population (all participants randomized to treatment).|||units on a scale||95% Confidence Interval|Mean
2668586|NCT01504997|Secondary|Completion Rate of Robot Assisted Surgery||During the surgery, an expected average of 5 hours|||||||
2668587|NCT01504997|Secondary|Relapse Free Survival||5 years|||||||
2663767|NCT01548742|Other Pre-specified|Clinically Significant Improvement in Self-reported PTSD Symptoms as Measured by the PCL|% of participants with clinically significant improvement in self-reported PTSD symptoms defined as a reduction of 10 points or more on the PCL.|Weeks 9 and 17|Intent to treat analysis|||percentage clinical responders||95% Confidence Interval|Number
2663768|NCT01548742|Primary|PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up|The PCL is a valid and reliable measure of PTSD symptoms. Score range from 17-85; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 10 or more points on the PCL.|Baseline, Weeks 3, 6, 9 and 17|Intent to treat population (all participants randomized to treatment).|||units on a scale||95% Confidence Interval|Mean
2663769|NCT01548690|Secondary|Neurological Function Measured by the Orientation Log (O-log)|The orientation log focuses on orientation to place, time, and circumstance. There are 10 items on the orientation log, which are scored 0-3. A spontaneous correct response is awarded 3 points. A spontaneous response that is lacking or incorrect, but a correct response is provided following a logical cue is awarded 2 points. A score of 1 is given if spontaneous and cued responses are lacking or incorrect, but a correct response is provided in a recognition format. A score of 0 is given if the spontaneous, cued, or recognition format does not generate a correct answer. Scores from the 10 items are summed and the final score ranges from 0 to 30.|30 Days|All patients who consented to the study and had the intravenous infusion of study drug initiated and Orientation log (O-log) assessment scores available.|||units on a scale||Standard Deviation|Mean
2663770|NCT01548690|Secondary|Neurological Function Measured by the West Haven Criteria (WHC) for Hepatic Encephalopathy|The West Haven Criteria (WHC) for Hepatic Encephalopathy measures the severity of encephalopathy and patient's level of consciousness. The scale ranges from 0 to 4; a minimum score of 0 represents a better outcome, and a maximum total score of 4 represents a worse outcome. A score of 0 corresponds to normal consciousness and behavior and normal neurological examination. A score of 1 corresponds to mild lack of awareness, shortened attention span, and impaired addition or subtraction; mild asterixis or tremor. A score of 2 corresponds to lethargy, disorientated or inappropriate behavior, obvious asterixis; slurred speech. A score of 3 corresponds to somnolent but arousable, gross disorientation or bizarre behavior, muscle rigidity and clonus; hyperreflexia. A score of 4 corresponds to coma and decerebrate posturing.|120 hours from start of infusion|All patients who consented to the study and had the intravenous infusion of study drug initiated and West Haven Criteria (WHC) for Hepatic Encephalopathy assessment scores available.|||units on a scale||Standard Deviation|Mean
2663771|NCT01548690|Secondary|Change in Ammonia|To evaluate the effect of OCR-002 on ammonia levels in patients with acute liver failure/severe acute liver injury|Baseline and 72 Hours|All patients who consented to the study and had the intravenous infusion of study drug initiated for up to 72 hours and available venous or arterial ammonia levels.|||Percent Change||Standard Deviation|Mean
2663772|NCT01548690|Secondary|Measurement of OCR-002 Plasma Concentration|To evaluate the steady state pharmacokinetic and pharmacodynamic profile of OCR-002 in patients with impaired and intact renal function using urinary phenylacetylglutamine (PAGN) as a surrogate marker|24 Hours after last infusion|All patients who consented to the study and had the intravenous infusion of study drug initiated for up to 120 hours and had results available from serum and urine samples measuring the pharmacokinetic (PK), pharmacodynamic profile (phenylacetic acid (PAA), ornithine) and urinary phenylacetylglutamine (PAGN) levels.|||micrograms per millileter||Standard Deviation|Mean
2663773|NCT01548690|Primary|Number of Participants That do Not Tolerate the Administered Dose and Had Grade 3 or 4 Treatment Emergent Adverse Events as a Measure of Safety and Tolerability|To evaluate the safety and tolerability of OCR-002 in patients with acute liver failure/severe acute liver injury|30 Days|All patients who consented to the study, completed screening and had the intravenous infusion of study drug initiated|||Participants|||Count of Participants
2663774|NCT01548651|Secondary|Monocyte Inflammatory Protein NFkappaB(%)|The percentage change in monocyte inflammatory proteins NFkappaB (%) from baseline.|6 months|This data was not collected.||||||
2663775|NCT01548651|Secondary|Left Ventricular Ejection Fraction (LVEF)(%).|The change in Left ventricular function measured as the percentage change in left ventricular ejection fraction (LVEF)(%) from baseline as measured by by magnetic resonance imaging.|6 months|This data was not collected.||||||
2663776|NCT01548651|Primary|Myocardial and Hepatic Fat Content (Percentage)|The percentage change in hepatic fat (%) and myocardial fat (%) from baseline as measured by magnetic resonance imaging and spectroscopy (MRS).|6 months|This data was not collected.||||||
2663777|NCT01548638|Secondary|Subjective Symptoms (Nicotine Withdrawal)|"Subjects were asked to complete the Minnesota Nicotine Withdrawal Scale - Revised version (MNWS). The scale assesses eight DSM-IV items of nicotine withdrawal. The subjective symptoms listed above were assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt).~The range of possible total scores on the MNWS is 0-60, with higher values indicating an increased nicotine withdrawal. This range of scores represent a total score; there are no subscales."|Days 7, 14, 21, 28, 35, and 43; Baseline session||||units on a scale||Standard Deviation|Mean
2663778|NCT01548638|Secondary|Subjective Symptoms (Negative Affect)|"Subjects were asked to complete the Positive and Negative Affect Scale (PANAS) to assess symptoms of negative affect (the positive affect scale was not administered). This 10-item scale assesses was assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt).~The range of possible total scores on the PANAS negative affect scale is 10-50, with higher values indicating an increased nicotine withdrawal. This range of scores represent a total score; there are no subscales within the negative affect scale of the PANAS."|Days 7, 14, 21, 28, 35, and 43; Baseline session||||units on a scale||Standard Deviation|Mean
2663792|NCT01548573|Primary|Identification of Drug Resistant Genes|To determine whether repeated bone marrow samples analyzed for gene expression profiling (GEP) can identify genes related to drug resistance in myeloma. The drug resistant genes or the gene products might then be targeted specifically to eradicate myeloma cells surviving tandem transplantation.|5 years|"Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).~Data for outcome measure 2 were not collected."||||||
2668588|NCT01504997|Secondary|Overall Survival||5 years|||||||
2663779|NCT01548638|Secondary|Side Effects of Galantamine|"Side effects of galantamine were assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt). A 37-item checklist of side effects based on the product insert (e.g., Nausea, Vomiting, Diarrhea, Loss of appetite, Stomach pain, Constipation, Gastroesophageal Reflux Problems (Heartburn)) was administered to participants at all study visits after the Intake. An open-ended side effects question was also be included.~Items were measured on a scale from 0 (None) to 3 (Severe).~The side effect summary score (total side effects averaged from the 37 item checklist) at each visit is reported below. Each score ranges from 0 (None) to 3 (Severe)."|Days 7, 14, 21, 28, 35, 37, 39, and 43; Baseline session||||units on a scale||Standard Deviation|Mean
2663780|NCT01548638|Secondary|Subjective Symptoms (Smoking Urges)|"During each visit, we asked subjects to complete the Questionnaire for Smoking Urges-Brief (QSU-B). This measure is an index of urges to smoke, or cigarette craving. The subjective symptoms listed above will be assessed at the following in-person sessions: Baseline session, Days 7, 14, 21, and 28 (brief monitoring visits), Day 35 (Day before Target Quit Day), and Days 37, 39, and 43 (during the 7-day quit attempt).~The range of possible scores on the QSU-B is 10-70, with higher values indicating increased urges to smoke. This range of scores represents a total score; there are no subscales."|Days 7, 14, 21, 28, 35, and 43; Baseline session||||units on a scale||Standard Deviation|Mean
2663781|NCT01548638|Secondary|Cognitive Performance: Working Memory Accuracy|"Participants will complete neurocognitive test designed to test working memory and attention and are similar to computer games, in that participants will push a button in response to the pictures they see. Working memory was measured using a computerized N-back task. During the N-back, participants are instructed to remember the location of a stimulus, a grey circle that is approximately 5 cm in diameter, as it appears randomly in 8 possible locations around the perimeter of a computer screen. Stimulus duration is 200 ms, followed by an interstimulus interval (ISI) of 2800 ms. The N-back task includes 4 conditions of varying difficulty levels: the 0-back, 1-back, 2-back, and 3-back.~Number of correct responses (true positives) is described below.~The maximum number of correct responses is 60."|At Baseline (Day 0), Day 35 (Day before Target Quit Day), and Day 43||||correct responses||Standard Deviation|Mean
2663782|NCT01548638|Secondary|Cognitive Performance: Working Memory Reaction Time|"Participants will complete neurocognitive test designed to test working memory and attention and are similar to computer games, in that participants will push a button in response to the pictures they see. Working memory was measured using a computerized N-back task. During the N-back, participants are instructed to remember the location of a stimulus, a grey circle that is approximately 5 cm in diameter, as it appears randomly in 8 possible locations around the perimeter of a computer screen. Stimulus duration is 200 ms, followed by an interstimulus interval (ISI) of 2800 ms. The N-back task includes 4 conditions of varying difficulty levels: the 0-back, 1-back, 2-back, and 3-back.~Median reaction time to correct responses is described below.~Typical responses range from 250 ms to 1500 ms."|At Baseline (Day 0), Day 35 (Day before Target Quit Day), and Day 43||||ms||Standard Deviation|Mean
2663783|NCT01548638|Primary|Number of Days of Abstinence During a 7-day Quit Attempt|Participants will undergo a 6-week study medication period. Day 36 will be the beginning of a 7-day practice quit attempt, during which number of days of abstinence will be assessed.|Days 36-43; following a 5-week dose run-up||||days||Full Range|Mean
2663784|NCT01548599|Secondary|Change From Baseline in Weekly Household Food Expenditures at Year 1|Assess weekly household food expenditures in Kenyan shillings. A modification of the World Bank Living Standards Measurement Study (LSMS) questionnaire will be used to measure expenditures for food consumption.|1 year|All 140 participants enrolled|||Kenyan shillings/week||Standard Error|Mean
2663785|NCT01548599|Secondary|Change From Baseline in Food Insecurity at Year 1|Collect and analyze measures of food insecurity as assessed by the Household Food Insecurity Access Scale (HFIAS). Minimum=9, maximum=36. A higher score means worse outcomes (i.e. greater food insecurity).|Baseline and 1 year|All 140 enrolled participants|||Units on a scale||Standard Error|Mean
2663786|NCT01548599|Secondary|Percentage of Participants Who Engaged in Unprotected Sex With a Sero-Negative Partner at 1 Year|Assess sexual risk behaviors including unprotected sex with a partner that is HIV-negative or of unknown serostatus.|1 year|118 sexually active participants who completed endline data collection.|||Percentage of participants|||Number
2663787|NCT01548599|Secondary|Change From Baseline in Frequency of Food Consumption at 1 Year|Food frequency will be measured as the number of different foods or food groups and the frequency consumed over a given reference period, as adapted from the World Food Programme Food Consumption Score. Minimum = 0, maximum = 392. Higher scores reflect more frequent food consumption.|Baseline and 1 year|All 140 enrolled participants|||Total times consumed/week||Standard Error|Mean
2663788|NCT01548599|Primary|Change From Baseline in CD4 Count at 1 Year|Compare change in cluster of differentiation 4 (CD4) count from baseline to 1 year among intervention and control arms.|1 year|All 140 enrolled participants|||cells/microliter||Standard Error|Mean
2663789|NCT01548599|Primary|Number of Participants With HIV Viral Load < 40 Copies/ML at 1 Year|Compare the percentage of participants who achieve HIV viral suppression (defined as <40 copies/mL) at 1 year among intervention and control arms.|1 year|All 140 enrolled participants|||Participants|||Count of Participants
2663790|NCT01548573|Secondary|Overall Survival|To determine the median overall survival based on an intent-to-treat analysis, which should exceed 10 years, based on the projected 10-year survival of Total Therapy III, keeping in mind that participants are included in this protocol with up to 12 months of prior therapy.|10 years|"Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).~Data for outcome measure 4 were not collected."||||||
2663791|NCT01548573|Secondary|Number of Grade 3 Non-hematologic and Grade 4 Hematologic Serious Adverse Events Associated With the Addition of Bortezomib, Thalidomide, and Dexamethasone Into Autologous Transplant Regimens.|To determine whether bortezomib, thalidomide and dexamethasone with transplant 1 and velcade/gemcitabine with transplant 2 can be safely incorporated into well-tested pre-transplant regimens of high-dose melphalan and carmustine/melphalan in doses equivalent to the BEAM(BCNU, etoposide, arabinoside, melphalan)regimen. Treatment-related toxicities will be compared to those reported in the literature using similar intensive approaches.|2 years|"Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).~Data for outcome measure 3 were not collected."||||||
2663793|NCT01548573|Primary|Event-Free Survival (EFS)|To determine whether, in comparison to Total Therapy II, the median Event-Free Survival (EFS) can be increased from 4.8 years to 7.2 years, which represents an increase in median EFS of approximately 50%, based on an intent-to-treat analysis.|8 years|"Enrollment halted prematurely. Study met stopping rules (3 or more of the first 20 participants died due to treatment-related toxicity).~Data for outcome measure 1 were not collected."||||||
2663794|NCT01548417|Secondary|Drinking|Number of standard drinks per week using the Timeline Followback Interview. Total number of alcoholic drinks consumed per week with a minimum value of 0 and a maximum value of 70.|2 weeks|Three randomized subjects who met exclusionary criteria were not included in the regression analysis for drinking: two subjects were excluded for unreliable reporting and one subject was excluded for being treatment seeking.|||alcoholic drinks per week||Standard Error|Mean
2663795|NCT01548417|Primary|Craving to Drink|Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.|1 week|1 participant who completed the study had missing VAS scores.|||units on a scale||Standard Error|Mean
2663796|NCT01548404|Secondary|Change From Baseline in 5-D Pruritus Scale at Week 12|The 5-D Pruritus Scale is a 1-page, 5-question tool used in clinical trials to assess 5 dimensions of background itch: degree, duration, direction, disability, and distribution. Each question corresponds to 1 of the 5 dimensions of itch; participants were to rate their symptoms over the preceding 2-week period on a 1 to 5 scale, with 5 being the most affected. After the summation of individual score, the total score ranges from 5 (least affected) to 25 (most affected).|Baseline to Week 12|FAS population.|||units on a scale||Standard Deviation|Mean
2663797|NCT01548404|Secondary|Change From Baseline in Pruritus Numerical Rating Scale (NRS) to Week 12- LOCF|Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]). The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF.|Baseline to Week 12|FAS population. Number of participants analyzed = participants with available data for this endpoint.|||units on a scale||Standard Deviation|Mean
2663798|NCT01548404|Secondary|Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 12- LOCF|SCORAD is a clinical tool for assessing the severity of AD developed by the European Task Force on Atopic Dermatitis (Severity scoring of atopic dermatitis: the SCORAD index). Consensus Report of the European Task Force on Atopic Dermatitis. Dermatology (Basel) 186 (1): 23-31. 1993. Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease). The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF.|Baseline to Week 12|FAS population.|||Units on a scale||Standard Deviation|Mean
2663799|NCT01548404|Secondary|Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 12 - LOCF|BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]). It was reported as a percentage of all major body sections combined. The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF.|Baseline to Week 12|FAS population.|||Percentage of BSA||Standard Deviation|Mean
2663800|NCT01548404|Secondary|Percent Change From Baseline in IGA Score at Week 12- LOCF|IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF.|Baseline to Week 12|FAS population.|||Percent change||Standard Deviation|Mean
2663801|NCT01548404|Secondary|Change From Baseline in EASI Score at Week 12- LOCF|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF.|Baseline to Week 12|FAS population.|||Units on a scale||Standard Deviation|Mean
2663802|NCT01548404|Secondary|Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI-50) at Week 12- LOCF|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-50 responders were the participants who achieved ≥50% overall improvement in EASI score from baseline to Week 12. The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF.|Week 12|FAS population.|||Percentage of participants|||Number
2663803|NCT01548404|Secondary|"Percentage of Participants With Investigator's Global Assessment (IGA) Score of 0 or 1 at Week 12- LOCF"|IGA is an assessment scale used to determine severity of AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear). The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF.|Week 12|FAS population.|||percentage of participants|||Number
2668589|NCT01504997|Primary|The Incidence of Post-operative Intra-abdominal Infectious Complications||Participants will be followed for the duration of hospital stay, an expected average of 10 days||||participants||90% Confidence Interval|Number
2663804|NCT01548404|Primary|Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 12- Last Observation Carried Forward (LOCF)|The EASI score was used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. The efficacy data were set to be missing after use of rescue medication and after early termination visit for participants who prematurely discontinued study treatment. All missing values were imputed by LOCF.|Baseline to Week 12|Full analysis set (FAS) population included all randomized participants who received at least one dose of study drug and had at least 1 post-baseline efficacy assessment.|||percent change||Standard Deviation|Mean
2663805|NCT01548339|Secondary|Length of Stay|total in hospital stay|30 postoperative days||||days||Inter-Quartile Range|Median
2663806|NCT01548339|Secondary|Postoperative Complications|postoperative complications graded according to Clavien classification|30 postoperative days||||Participants|||Count of Participants
2663807|NCT01548339|Primary|"Number of Participants With Adverse Event (Global Morbidity)."|any adverse event occurring from time of diagnosis until the 30th postoperative day|30 postoperative days||||Participants|||Count of Participants
2663808|NCT01548287|Secondary|Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on Actigraphy Recording.|Change from baseline in sleep efficiency after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data|Baseline and Week 4.|Subset of Primary Analysis Population with valid actigraphy data|||% (efficiency=% of time asleep)||90% Confidence Interval|Least Squares Mean
2663809|NCT01548287|Secondary|Change From Baseline in Latency of Persistent Sleep After 4 Weeks of Treatment, Based on Actigraphy Recording.|Change from baseline in latency of persistent sleep after 4 weeks of treatment, based on participants with valid baseline and week 4 actigraphy data|Baseline and Week 4.|Subset of Primary Analysis Set with valid actigraphy data|||Minutes||90% Confidence Interval|Least Squares Mean
2663810|NCT01548287|Secondary|Change From Baseline in Night Total Sleep Time After 4 Weeks of Treatment, Based on Actigraphy Recording.|Change from baseline in night total sleep time after 4 weeks of treatment: assessed if valid baseline and week 4 actigraphy data|Baseline and Week 4.|Subset of Primary Analysis Set with valid actigraphy data|||Minutes||90% Confidence Interval|Least Squares Mean
2663811|NCT01548287|Secondary|Change From Baseline in Latency to Persistent Sleep After 4 Weeks of Treatment, Based on PSG Measurements.||Baseline and Week 4.|Primary analysis set|||Rank transformed duration (minutes)||90% Confidence Interval|Least Squares Mean
2663812|NCT01548287|Secondary|Change From Baseline in Sleep Efficiency After 4 Weeks of Treatment, Based on PSG Measurements.||Baseline and Week 4.|Primary analysis set|||% change||90% Confidence Interval|Least Squares Mean
2663813|NCT01548287|Primary|Change From Baseline in Total Sleep Time (TST) After 4 Weeks of Treatment, Based on PSG Measurement.|Total sleep time (TST) is defined as the total time in minutes, that subjects were determined to be in a sleep state by polysomnography (PSG) measurement.|Baseline and Week 4.|Primary analysis set|||Minutes||90% Confidence Interval|Least Squares Mean
2663814|NCT01548040|Other Pre-specified|Visual Analogue Scales (VAS)|Pain change score in VAS from baseline to week 6 post-surgery|1 wk pre-operatively,3,6,12 and 52 post operatively|||||||
2663815|NCT01548040|Other Pre-specified|Stair Climb Test|Change in scores of physical performance measures|1 wk pre-operatively, 3,6,12,52 week post operatively|||||||
2663816|NCT01548040|Other Pre-specified|Timed to Get up and go|Change in scores of physical performance measures|1 wk pre-operatively, 3,6,12,52 week post operatively|||||||
2663817|NCT01548040|Other Pre-specified|Range of Motion|Change in scores of functional and physical performance scores|1 wk pre-operatively, 3,6,12,52 week post operatively|||||||
2663818|NCT01548040|Other Pre-specified|Questionnaires|Change in scores in patient outcome measures, functional measures and physical performance measures|1 wk pre-operatively, 3,6,12,52 week post operatively|||||||
2663819|NCT01548040|Other Pre-specified|Physical Therapy Sessions|Change in patient functional measures and number of therapy sessions required.|1 wk pre-operatively, 3,6,12,52 week post operatively|||||||
2663820|NCT01548040|Secondary|Percentage of Patients With Positive PASS|To determine whether Kneehab XP leads to earlier recovery (measured at the 6 week post-operative time point) when compared to a control group in patients undergoing total knee arthroplasty. Patient Acceptable Symptom State (PASS) is a yes/no answer to a specifically stated question about the patients satisfaction with their state. For clarity, Positive PASS implies that the answer that is given is Positive i.e. Yes|measured at the 6 week post-operative time point||||% of participants|||Number
2663821|NCT01548040|Primary|Isometric Strength Test|To determine the efficacy of Kneehab XP in promoting early quadriceps strength improvement (measured as the difference between the baseline time point and the 6 week post-operative time point) when compared to a control group in patients undergoing total knee arthroplasty. Isometric strength was measured using a Biodex Isokinetic Dynamometer machine on patients seated and secured to a chair and who performed 3 maximal voluntary contractions (MVC) for which the maximal torque is measured and a mean taken of 3 consecutive MVC's.|measured at the 6 week post-operative time point||||Newton-metres||Standard Deviation|Mean
2663822|NCT01547806|Secondary|Impact of Plerixafor in the Degree of Tumor Cell Contamination in the Final Product|Flow cytometry to detect tumor contamination.|Day 1 of apheresis|Because no data from any participant was sufficiently collected to assess tumor cell contamination, we were not able to determine the effect of plerixafor on this parameter.||||||
2663823|NCT01547806|Secondary|Degree of Tumor Cell Contamination in the Final Product|Flow cytometry to detect tumor contamination.|Day 1 of apheresis|No data from any participant was sufficiently collected to assess tumor cell contamination.||||||
2663824|NCT01547806|Secondary|Percentage of Patients That Achieved ≥ 2 x 10^6 But Less Than 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg (Day One Collection)|Percentage of patents achieving collecting the minimum but not optimal CD34 cell number.|Day one of collection||||percentage of patients|||Number
2663825|NCT01547806|Secondary|Percentage of Patients That Achieved or Did Not Achieve 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg|Here is the percentage of patients that achieved or did not achieve 5 x 10^6 CD34 cells/kg in a single apheresis.|Through Day 2 of collection||||percentage of patients|||Number
2663826|NCT01547806|Secondary|Percentage of Patients That Required Plerixafor + Granulocyte-colony Stimulating Factor (G-CSF) And Only G-CSF (no Plerixafor)|Percentage of patients that required Plerixafor injection in addition to G-CSF mobilization or none at all|One week of mobilization therapy||||percentage of patients|||Number
2663827|NCT01547806|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|27 months and 27 days||||Participants|||Count of Participants
2663828|NCT01547806|Primary|Number of Hematopoietic Progenitor Cell (HPC) Apheresis Products Collected and Cryopreserved for Subsequent Use in Autologous Hematopoietic Cell Transplantation (AHCT) in Subjects With Plasma Cell Myeloma (PCM)|The cryopreserved stem cells are stored under Good Manufacturing Practice (GMP) conditions in the National Institutes of Health (NIH) Department of Transfusion Medicine until a referring physician requests the products for standard clinical care.|Indefinitely until a referring physician requests the product for standard clinical care or until product(s) is no longer needed and disposed of||||products|||Number
2663829|NCT01547806|Primary|25th and 75th Percentile Values of Cluster of Differentiation 34 (CD34) Cells Collected|Progenitor cells by apheresis was determined by flow cytometry.|Through Day 2 of collection||||Number of CD34 cells per kg/BW (x 10EE6)|||Number
2663830|NCT01547806|Primary|Range of Cluster of Differentiation 34 (CD34) Cells Collected|Progenitor cells by apheresis was determined by flow cytometry.|Through Day 2 of collection||||Number of CD34 cells per kg/BW (x 10EE6)||Full Range|Median
2663831|NCT01547806|Primary|Median and Standard Deviation of Cluster of Differentiation 34 (CD34) Cells Collected (Per Kg Recipient Body Weight) (BW)|Progenitor cells by apheresis was determined by flow cytometry.|Through Day 2 of collection||||Number of CD34 cells per kg/BW (x 10EE6)||Standard Deviation|Median
2663832|NCT01547806|Primary|Average Number of Cluster of Differentiation 34 (CD34) Cells Collected (Per kg Recipient Body Weight (BW))|Progenitor cells by apheresis was determined by flow cytometry.|Through Day 2 of collection||||Number of CD34 cells per kg/BW (x 10EE6)||Standard Deviation|Mean
2663833|NCT01547806|Primary|Percentage of Patients Requiring 2 Days to Achieve at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight|Progenitor cells by apheresis was determined by flow cytometry.|Through Day 2 of collection||||percentage of patients|||Number
2663834|NCT01547806|Primary|Percentage of Patients Achieving at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight on Day 1 of Apheresis|Progenitor cells by apheresis was determined by flow cytometry. The stated goal was a minimum dose of 2x10EE^6/kg following apheresis.|Day 1 of apheresis||||percentage of patients|||Number
2663835|NCT01547728|Primary|Percentage of Patients Whose Activated Clotting Time (ACT) is Prolonged Beyond 480 Seconds With Recombinant Human Antithrombin Concentrate (rhAT) Administration|Restored antithrombin level is defined as an activated clotting time > 480 seconds 3 minutes after the initial dose of 500 units of rhAT is administered. The percentage of patients who meet this criterion will be summarized using a point estimate and a 95% confidence interval.|3 minutes after the initial dose of rhAT, Day 1 of the study|The study was terminated because there were too many barriers to enroll participants.||||||
2663836|NCT01547715|Secondary|Number of Subjects With Unsolicited Adverse Events|The safety of one dose of MenACWY -CRM was assessed in terms of the number of subjects reporting unsolicited adverse events. All AEs were recorded from day 1 to day 7; SAE, medically attended AEs and AEs Leading to premature withdrawal were recorded throughout the entire study period.|Day 1 through day 29|The analysis was performed on the safety analysis dataset.|||participants|||Number
2663837|NCT01547715|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination|The safety of one dose of MenACWY - CRM was assessed in terms of the number of subjects reporting solicited local and systemic reactions.|From day 1 to Day 7 post vaccination|The analysis was performed on the safety analysis set.|||Participants|||Number
2663838|NCT01547715|Secondary|Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination|The safety of one dose of MenACWY - CRM was assessed in terms of the number of subjects reporting any solicited local and systemic reactions.|From day 1 to Day 7 post vaccination|The analysis was performed on the safety analysis set, ie, all subjects in the exposed population who provided any post-baseline safety data.|||Participants|||Number
2663839|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup Y at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.|||Titer||95% Confidence Interval|Geometric Mean
2663840|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup Y at day 1.|Day 1|Analysis was done on the FAS.|||Titer||95% Confidence Interval|Geometric Mean
2663841|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.|||Titer||95% Confidence Interval|Geometric Mean
2663842|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 1.|Day 1|Analysis was done on the FAS.|||Titer||95% Confidence Interval|Geometric Mean
2663843|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.|||Titer||95% Confidence Interval|Geometric Mean
2668590|NCT01504971|Secondary|Association of Each Endoscopic Finding With Treatment Effect of PPI|Treatment effect of PPI is assessed by changes of symptom score|2 month|||||||
2663844|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 1.|Day 1|Analysis was done on the FAS.|||Titer||95% Confidence Interval|Geometric Mean
2663845|NCT01547715|Secondary|hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 29.|Day 29 ( ie, 1 month post vaccination)|Analysis was done on the FAS.|||Titer||95% Confidence Interval|Geometric Mean
2663846|NCT01547715|Secondary|hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 1.|Day 1|Analysis was done on the FAS.|||Titer||95% Confidence Interval|Geometric Mean
2663847|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
2663848|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 1.|Day 1|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
2663849|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W.|Day 29|Analysis was done on the FAS.|||Percentage of subjects||95% Confidence Interval|Number
2663850|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W at day 1.|Day 1|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
2663851|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
2663852|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 1.|Day 1|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
2663853|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 29.|Day 29 (ie, 1 month post vaccination)|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
2663854|NCT01547715|Secondary|Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1.|To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 1.|Day 1|Analysis was done on the FAS|||Percentage of subjects||95% Confidence Interval|Number
2663855|NCT01547715|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y.|The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup Y.|Day 29 (1 month post vaccination)|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
2663856|NCT01547715|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W.|The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup W.|Day 29 (1 month post vaccination)|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
2663857|NCT01547715|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C|The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup C.|Day 29 (1 month post vaccination)|Analysis was done on the FAS.|||Percentages of subjects||95% Confidence Interval|Number
2663858|NCT01547715|Primary|Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A.|"The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup A. Seroresponse is defined as:~For subjects with a pre-vaccination hSBA titer <1:4, a postvaccination hSBA titer≥1:8~For subjects with a pre-vaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the pre-vaccination titer."|Day 29 (1 month post vaccination)|Analysis was done on the Full Analysis Set (FAS), ie, all subjects in the exposed population who provided at least one evaluable serum sample whose assay result is available for at least one serogroup.|||Percentages of subjects||95% Confidence Interval|Number
2663859|NCT01547598|Secondary|Change From Baseline in Mean IOP at Week 6|IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 6. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.|Baseline, Week 6|Participants from the Full Analysis Set IOP population, all randomized participants who received at least one dose of study treatment and met study inclusion criteria, with IOP data available for analysis at the given time-point.|||mmHg||Standard Deviation|Mean
2663860|NCT01547598|Secondary|Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg|IOP is a measure of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.|Week 12|Participants from the mITT population, all randomized participants who received at least one dose of study treatment and met inclusion criteria, with data available for analysis.|||percentage of participants|||Number
2663861|NCT01547598|Secondary|Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline|IOP is a measurement of the fluid pressure in the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) measured at 8 AM, 12 Noon and 4 PM. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.|Baseline, Week 12|Participants from the mITT population, all randomized participants who received at least one dose of study treatment and met inclusion criteria, with data available for analysis.|||percentage of participants|||Number
2663862|NCT01547598|Secondary|Change From Baseline in Mean IOP at Week 12|IOP is a measurement of the fluid pressure inside the eye. IOP of the study eye (worse eye) was measured at 8 AM, 12 Noon and 4 PM at Week 12. For each eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements. A negative change from Baseline indicated improvement.|Baseline, Week 12|Participants from the Full Analysis Set IOP population, all randomized participants who received at least one dose of study treatment and met study inclusion criteria, with IOP data available for analysis at the given time-point.|||mmHg||Standard Deviation|Mean
2663863|NCT01547598|Primary|Mean Diurnal Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each study eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.|Week 12|Participants from the modified Intent-to-treat (mITT) population, all randomized participants who received at least one dose of study treatment and met inclusion criteria, with data available for analysis.|||mmHg||Standard Deviation|Mean
2663864|NCT01547390|Secondary|Number of Participants With IUGR, Early Preeclampsia, Severe Preeclampsia, Gestational Hypertension, Preterm Birth, Stillbirth, Placental Abruption, Antepartum Hemorrhage, Neonatal Death, NICU Admission, Miscarriage|"Intrauterine growth restriction (IUGR) - estimated fetal weight less than 10th percentile early preeclampsia - preeclampsia delivered prior to 34 weeks severe preeclampsia - blood pressure greater then 160/110 gestational hypertension - hypertension without features of preeclampsia preterm birth, stillbirth, placental abruption, antepartum hemorrhage, neonatal death, NICU admission, miscarriage.~Statistical significance not reported due to the low recruitment and poor patient compliance."|within 3 months of delivery||||participants|||Number
2663865|NCT01547390|Primary|Number of Participants With Preeclampsia|Preeclampsia diagnosed per ACOG criteria: Blood pressure greater than 140/90 on 2 occasions 6 hrs apart and significant proteinuria (greater than 300mg in 24hrs).|within 3 months prior to delivery||||Participants|||Count of Participants
2663866|NCT01547299|Secondary|Number of Participants With Adverse Events (AEs) That Led to Dose Interruption, Dose Reduction, and Study Drug Discontinuation|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|From baseline up to 210 days|All participants who received at least 1 partial dose of enzalutamide (safety population).|||participants|||Number
2663867|NCT01547299|Secondary|Change From Baseline in Serum Testosterone at Day 180|To determine serum hormone effects as measured by change in testosterone at baseline and at completion of therapy.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a serum testosterone result at baseline and 180 days post baseline. Here, N signifies number of participants evaluable for this specified outcome measure."|||ng/mL||Full Range|Median
2663868|NCT01547299|Secondary|Serum Testosterone: Day 180||Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a 180 days post baseline serum testosterone result. Here, N signifies number of participants evaluable for this specified outcome measure."|||ng/mL||Full Range|Median
2663869|NCT01547299|Secondary|Serum Testosterone: Baseline||Baseline|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline serum testosterone result. Here, N signifies number of participants evaluable for this specified outcome measure."|||ng/mL||Full Range|Median
2663870|NCT01547299|Secondary|Change From Baseline in Serum Dihydrotestosterone (DHT) at Day 180|To determine serum hormone effects as measured by change in DHT values from baseline to the completion of therapy.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a serum DHT result at baseline and 180 days post baseline. Here, N signifies number of participants evaluable for this specified outcome measure."|||ng/mL||Full Range|Median
2663871|NCT01547299|Secondary|Serum Dihydrotestosterone (DHT): Day 180||Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with 180 days post baseline serum DHT result. Here, N signifies number of participants evaluable for this specified outcome measure."|||ng/mL||Full Range|Median
2663872|NCT01547299|Secondary|Serum Dihydrotestosterone (DHT): Baseline||Baseline|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline serum DHT result. Here, N signifies number of participants evaluable for this specified outcome measure."|||ng/mL||Full Range|Median
2663873|NCT01547299|Secondary|Pharmacodynamic Effects: Assessment of Androgen Receptor Signaling as Measured by Intensity of Androgen Receptor Immunohistochemical (IHC) Staining|To determine the effects of triplet therapy and enzalutamide alone on androgen receptor signaling in prostatectomy specimens. Androgen receptor (AR) was a type of nuclear receptor that was activated by binding either of the androgenic hormones, testosterone, or dihydrotestosterone in the cytoplasm and then translocating into the nucleus. Androgen receptor (AR) signaling represented the major therapeutic target for treating metastatic prostate cancer. Assessment of androgen receptor signaling was measured by intensity of androgen receptor IHC staining and were graded as 0 (absent), 1 (weak), 2 (moderate) and 3 (strong). Percentage of participants within each grade are reported below.|Day 180|All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local pathologist.|||percentage of participants|||Number
2663874|NCT01547299|Secondary|Pharmacodynamic Effects: Assessment of Mitotic Index|Assessment was performed to determine the effects of triplet therapy and enzalutamide alone on mitotic index. Mitotic index was defined as the ratio between the numbers of cells in a population undergoing mitosis to the number of cells in a population not undergoing mitosis in prostatectomy specimens.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local pathologist. Here, N signifies number of participants evaluable for this specified outcome measure."|||ratio||Standard Deviation|Mean
2663875|NCT01547299|Secondary|Pharmacodynamic Effects: Assessment of Apoptosis|To determine the effects of triplet therapy and enzalutamide alone on apoptosis in prostatectomy specimens. Apoptosis was a process of biochemical events that lead to characteristic cell changes and death.|Day 180|Data for this outcome measure was not collected as assessment of apoptosis was not performed due to limited amounts of tissue samples available.||||||
2663876|NCT01547299|Secondary|Pharmacodynamic Effects: Tissue Testosterone|To determine pharmacodynamic effects as measured by the amount of tissue testosterone in prostatectomy specimens following radical prostatectomy.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the central pathologist. Here, N signifies number of participants evaluable for this specified outcome measure."|||picogram per milligram||Standard Deviation|Mean
2663877|NCT01547299|Secondary|Pharmacodynamic Effects: Tissue Dihydrotestosterone (DHT)|To determine pharmacodynamic effects as measured by the amount of tissue DHT in prostatectomy specimens following radical prostatectomy.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the central pathologist. Here, N signifies number of participants evaluable for this specified outcome measure."|||picogram per milligram||Standard Deviation|Mean
2663878|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Mental Component Summary|The Twelve-Item Short Form Version 2 was HRQoL instrument that measured general health and well-being across physical and mental components. The mental health domain score had 2 items scored on a scale of 1 to 5 where for 1 item 1=all of the time person felt calm and peaceful to 5=none of the time person felt calm and peaceful. The score ranged from 1 to 5, where higher scores meant worse mental status. For other item 1=all of the time person felt downhearted and blue to 5=none of the time person felt downhearted and blue. The score ranged from 1 to 5, where higher scores meant better mental status. Best change from baseline category in mental component summary ranged from worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference was defined as one-half the standard deviation of the score of interest at baseline.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
2663879|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Role-Emotional Domain Score|The Twelve-Item Short Form Version 2 was HRQoL instrument that measured general health and well-being across physical and mental components. The mental health domain score had 2 items scored on a scale of 1 to 5, where higher scores indicated worse mental status. The total score ranged from 1 to 10, where higher scores indicated worse mental status. Best change from baseline category in mental component summary ranged from worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference was defined as one-half the standard deviation of the score of interest at baseline.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
2663880|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 Physical Functioning Domain Score|The Twelve-Item Short Form Version 2 was HRQoL instrument that measured general health and well-being across physical and mental components. The physical functioning domain score contained 2 items each scored on a scale of 1 to 5 where 1=excellent physical functioning to 5=poor physical functioning. Physical functioning domain total score ranged from 1 to 10, where higher scores indicated poor physical functioning. Best change from baseline category in physical functioning domain score ranged from worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference was defined as one-half the standard deviation of the score of interest at baseline.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
2663881|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With Twelve-Item Short Form Version 2 General Health Domain Score|The Twelve-Item Short Form Version 2 was HRQoL instrument that measured general health and well-being across physical and mental components. The general health domain score contained 1 item scored on a scale of 1 to 5 where 1=excellent to 5=poor health, where higher score indicated worse health status. Best change from baseline category in general health domain score ranged from worsened (decrease of at least 1 minimally important difference), stable (changed by less than 1 minimally important difference), or improved (increase of at least 1 minimally important difference). Minimally important difference was defined as one-half the standard deviation of the score of interest at baseline.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
2663888|NCT01547299|Secondary|Percentage of Participants With Reduction in Prostate-Specific Antigen (PSA)|To determine the effects on PSA as measured by the percentage of participants with PSA less than (<) 0.2 nanogram per milliliter (ng/mL), and a 50 percent (%) and 90% decrease in PSA value prior to prostatectomy. Prostate-specific antigen (PSA) was a protein produced by normal, as well as malignant, cells of the prostate gland.|Day 195|All participants randomly assigned to study treatment (intent-to-treat population) with a baseline PSA and at least one post baseline PSA.|||percentage of participants||95% Confidence Interval|Number
2663882|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Bother Subscale Score|EPIC hormonal bother subscale score was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's hormonal function. EPIC hormonal bother subscale was a component of hormonal domain that was evaluated on a distinct set of questions. It was measured on a scale ranged from 0 (worst) to 100 (best) scale with higher scores representing less hormonal bothering. Best change from baseline category in EPIC hormonal bother subscale score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicated changed by less than 1 minimally important difference and improved indicated increase of at least 1 minimally important difference. Minimally important difference was defined as one-half of the standard deviation baseline score. Number of participants within each category are reported below.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
2663883|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Function Subscale Score|EPIC hormonal function subscale score was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's hormonal function. EPIC hormonal function subscale was a component of hormonal domain that was evaluated on a distinct set of questions. It was measured on a scale ranged from 0 (worst) to 100 (best) scale with higher scores representing better hormonal function. Best change from baseline category in EPIC hormonal function subscale score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicated changed by less than 1 minimally important difference and improved indicated increase of at least 1 minimally important difference. Minimally important difference was defined as one-half of the standard deviation baseline score. Number of participants within each category are reported below.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
2663884|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Hormonal Domain Summary Score|EPIC Hormonal Domain was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's hormonal function. It was measured on a scale ranged from 0 (worst) to 100 (best) scale with higher scores representing better hormonal function. Best change from baseline category in EPIC hormonal domain summary score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicated changed by less than 1 minimally important difference and improved indicated increase of at least 1 minimally important difference. Minimally important difference was defined as one-half of the standard deviation baseline score. Number of participants within each category are reported below.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
2663885|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Sexual Bother Subscale Score|EPIC sexual bother subscale was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's sexual function and sexual satisfaction. EPIC sexual bother subscale was a component of sexual domain that was evaluated on a distinct set of questions. It was measured on a scale ranged from 0 (worst) to 100 (best) with higher scores representing less sexual bother and difficulty. Best change from baseline category in EPIC sexual bother subscale score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicated changed by less than 1 minimally important difference and improved indicated increase of at least 1 minimally important difference. Minimally important difference was defined as one-half of the standard deviation of baseline score. Number of participants within each category are reported below.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
2663886|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With Expanded Prostate Cancer Index Composite (EPIC) Sexual Function Subscale Score|EPIC sexual function subscale was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's sexual function and sexual satisfaction. EPIC sexual function subscale was a component of sexual domain that was evaluated on a distinct set of questions. It was measured on a scale ranged from 0 (worst) to 100 (best) with higher scores representing better sexual function. Best change from baseline category in EPIC sexual function subscale score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicated changed by less than 1 minimally important difference and improved indicated increase of at least 1 minimally important difference. Minimally important difference was defined as one-half of the standard deviation of baseline score. Number of participants within each category are reported below.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
2663887|NCT01547299|Secondary|Health-Related Quality of Life (HRQoL): Number of Participants With The Expanded Prostate Cancer Index Composite (EPIC) Sexual Domain Summary Score|EPIC sexual domain was HRQoL instrument that measured the effects of prostate cancer treatment on a participant's sexual function and sexual satisfaction. Sexual domain summary score was measured on a scale ranged from 0 (worst) to 100 (best) with higher scores representing better sexual function and satisfaction. Best change from baseline category in EPIC sexual domain summary score ranged from worsened to improved where worsened indicated decrease of at least 1 minimally important difference, stable indicated changed by less than 1 minimally important difference and improved indicated increase of at least 1 minimally important difference. Minimally important difference was defined as one-half of the standard deviation of baseline score. Number of participants within each category are reported below.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline and at least one post baseline score. Here, N signifies number of participants evaluable for this specified outcome measure."|||participants|||Number
2663889|NCT01547299|Secondary|Time to Prostate-Specific Antigen (PSA) Nadir|To determine the effects on PSA as measured by the time to the lowest post baseline PSA value prior to prostatectomy. Prostate-specific antigen (PSA) was a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA nadir was the participant's lowest observed post baseline PSA value.|Day 195|All participants randomly assigned to study treatment (intent-to-treat population) with a baseline PSA and at least one post baseline PSA.|||days||Full Range|Median
2663890|NCT01547299|Secondary|Prostate-Specific Antigen (PSA) Nadir|To determine the effects on PSA as measured by the lowest post baseline PSA value prior to prostatectomy. Prostate-specific antigen (PSA) was a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA nadir was the participant's lowest observed post baseline PSA value.|Day 195|"All participants randomly assigned to study treatment (intent-to-treat population) with a baseline PSA and at least one post baseline PSA. Here, N signifies number of participants evaluable for this specified outcome measure."|||microgram per liter (mcg/L)||Full Range|Median
2663891|NCT01547299|Secondary|Percentage of Participants With Positive Lymph Nodes|To determine the percentage of participants with positive lymph nodes at prostatectomy as assessed by the local and central pathologist. Lymph nodes were small clumps of immune cells that act as filters for the lymphatic system. Lymph nodes with cancer cells in them were called positive lymph nodes.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist. Here, N signifies number of participants evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
2663892|NCT01547299|Secondary|Percentage of Participants With Positive Seminal Vesicles|To determine the percentage of participants with positive seminal vesicles at prostatectomy as assessed by the local and central pathologist. Seminal vesicles or seminal glands, were defined as a pair of simple tubular glands located within the pelvis. They secrete fluid that partly composes the semen. Seminal vesicles with cancer cells in them were called positive seminal vesicles.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist. Here, N signifies number of participants evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
2663893|NCT01547299|Secondary|Percentage of Participants With Extracapsular Extension: Central Review|To determine the percentage of participants with extracapsular extension at prostatectomy as assessed by the central pathologist. Extracapsular extension was defined as prostate cancer cells when extended into the prostate capsule or outer lining of the prostate gland.|Day 180|"All participants randomly assigned to study treatment with a prostatectomy sample evaluated by the central pathologist. One participant in the Enzalutamide treatment arm was excluded from the analysis because the result reported by the central lab was indeterminate. Here, N signifies number of participants evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
2663894|NCT01547299|Secondary|Percentage of Participants With Extracapsular Extension: Local Review|To determine the percentage of participants with extracapsular extension at prostatectomy as assessed by the local pathologist. Extracapsular extension was defined as prostate cancer cells when extended into the prostate capsule or outer lining of the prostate gland.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local pathologist. Here, N signifies number of participants evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
2663895|NCT01547299|Secondary|Percentage of Participants With Positive Surgical Margins|To determine the percentage of participants with positive surgical margins at prostatectomy as assessed by the local and central pathologist. Surgical margin, also known as tumor free margin referred to the visible normal tissue or skin margin that was removed with the surgical excision of a tumor, growth, or malignancy. The margin was described as positive when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist. Here, N signifies number of participants evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
2663896|NCT01547299|Primary|Pathologic Complete Response Rate|Pathologic complete response rate was defined as percentage of participants with pathologic complete response. Pathologic complete response rate following triplet therapy (enzalutamide in combination with leuprolide and dutasteride) and enzalutamide alone when administered as neoadjuvant therapy for 180 days prior to prostatectomy in participants with localized prostate cancer. Pathologic complete response was defined as the absence of morphologically identifiable carcinoma in the prostatectomy specimen, as assessed by the local and central pathologist.|Day 180|"All participants randomly assigned to study treatment (intent-to-treat population) with a prostatectomy sample evaluated by the local and central pathologist. Here, N signifies number of participants evaluable for this specified outcome measure."|||percentage of participants||95% Confidence Interval|Number
2663897|NCT01547286|Secondary|Coefficient of Variation Squared of Perfusion|Coefficient of variation squared of the perfusion in the imaged lung. This measures the overall heterogeneity of perfusion in the imaged lung.|7 hours after allergen administration||||unitless||Standard Deviation|Mean
2663898|NCT01547286|Secondary|Coefficient of Variation Squared of Perfusion|Coefficient of variation squared of the perfusion in the imaged lung. This measures the overall heterogeneity of perfusion in the imaged lung.|3 hours after allergen administration||||unitless||Standard Deviation|Mean
2663899|NCT01547286|Primary|Percentage Change in the Ratio of Mean-normalized Perfusion Within Ventilation Defective Regions Relative to Outside|Blood flow relative to the mean blood flow of the lung (mean normalized perfusion) inside areas that have reduced ventilation (Vdefs) relative to outside the Vdefs. Or, another way of writing this is: (Blood flow inside Vdefs/mean blood flow of the lung)/(Blood flow outside Vdefs/mean blood flow of the lung).|7 hours after allergen administration||||percentage||Standard Deviation|Mean
2663900|NCT01547286|Primary|Percentage Change in the Ratio of Mean-normalized Perfusion Within Ventilation Defective Regions Relative to Outside|Blood flow relative to the mean blood flow of the lung (mean normalized perfusion) inside areas that have reduced ventilation (Vdefs) relative to outside the Vdefs. Or, another way of writing this is: (Blood flow inside Vdefs/mean blood flow of the lung)/(Blood flow outside Vdefs/mean blood flow of the lung).|3 hours after allergen administration||||percentage||Standard Deviation|Mean
2663901|NCT01547247|Secondary|Success Rate of Minimal Sedation Colonoscopy|A successful minimal sedation colonoscopy was defined as reaching the cecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam.|3 months||||percentage of all subjects in arm|||Number
2663902|NCT01547247|Secondary|Patient Comfort During Insertion Phase of the Colonoscopy||3 months|||||||
2663903|NCT01547247|Primary|Cecal Intubation Time|The primary endpoint (cecal intubation time) was defined as a time between introduction of the colonoscope into the anus and reaching the cecum.|3 months|Statistical power was calculated for the primary endpoint. A sample size of 93 subjects per arm was calculated using two-tailed alfa 0.05, beta 0.2, assuming that difference 20 % in intubation times would have been clinically relevant.|||minutes||95% Confidence Interval|Number
2663904|NCT01547130|Secondary|Total Preparation Time|Patients in both groups were provided with a questionnaire to record the total time required from start of assigned prep to completion of the prep.|Upto 24 weeks|Patients in both groups were provided with a questionnaire to record the total time required from start of assigned prep to completion of the prep.|||hours||Full Range|Mean
2663905|NCT01547130|Secondary|Patient-reported Adverse Events.|Patients from both groups reported adverse events in a symptom questionnaire.|Upto 24 weeks|Patients from both groups reported adverse events in a symptom questionnaire.|||participants|||Number
2663906|NCT01547130|Secondary|Subjective Grading by Patients on Willingness to Repeat the Large Bowel Preparation.|"Subjects rated the SCC as Willingness to repeat the same prep in future"|Upto 24 weeks|Patients completed a questionnaire where they rated willingness to repeat the preps on a 1-5 Likert scale.|||participants|||Number
2663907|NCT01547130|Secondary|Palatability of Bowel Prep|"Patients completed a symptom questionnaire where they rated solution palatability of their assigned prep on a 1-5 Likert scale. A rating of more than 3 was considered as Palatable."|Upto 24 weeks|All subjects enrolled and completed the bowel preparation. .|||participants|||Number
2663908|NCT01547130|Primary|Efficacy of Large Bowel Cleansing as Assessed by the Physician Performing the Colonoscopy|"The primary endpoint was the success rate of the preparations. Preparation efficacy was evaluated by a single, blinded endoscopist (V.A.), who performed all of the colonoscopies. The evaluation involved the rating of six anatomical segments of the colon (rectum, sigmoid, descending colon, transverse colon, ascending colon and cecum) on the 5 point Arya Bowel Prep Scale (ABPS). Aggregating the segmental scores resulted in overall scores. Grade A was defined as a total overall score of 19-24, grade B as a score of 13-18, grade C as a score of 7-12, and grade D as a score of 0-6. Grade A or B preparation was considered successes, while grade C or D was considered failures. To assess the reliability of ABPS, we trained 4 gastroenterologists and 3 fellows."|Within 48 hours of bowel preparation|The non-inferiority margin was set at -15%. This means the intervention will be considered non-inferior if the difference in success rates is less than 15%. The study was designed to have 90% power to establish non-inferiority when the two treatment groups are equivalent using a one-tailed test at the 5% significance level.|||Score||Standard Deviation|Mean
2663909|NCT01547000|Primary|Yale Global Tic Severity Scale (YGTSS)|The YGTSS is a clinician-rated scale that begins with a systematic inquiry of tic symptoms in the preceding week. Current motor and phonic tics are rated separately according to number, frequency, intensity, complexity, and interference, each rated on 0 to 5 scale with higher scores indicating greater severity/worse outcome (Leckman et al. 1989). The YGTSS yields a total motor score (0-25), a total phonic score (0-25), a total tic score (sum of total motor and total phonic scores; 0-50), and an impairment score (0-50). Higher scores indicate greater severity/worse outcome.|8 weeks||||units on a scale||Standard Deviation|Mean
2663910|NCT01546922|Secondary|Change in Perceived Common Somatic Complaints After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|The patients report common somatic complaints by filling in structured daily diaries.|during treatment period 1 (that is from week 1 to week 10 from baseline) and during treatment period 2 (that is from week 11 to week 20 from baseline).|||||||
2663911|NCT01546922|Secondary|Change in Somatosensation After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|Measures of somatosensation: the mechanical detection threshold, the mechanical pain threshold, mechanical pain sensitivity, dynamic mechanical allodynia, wind up ratio and the pressure pain threshold.|After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).|||||||
2663912|NCT01546922|Secondary|Change in Metabolic Profile After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|Cardiovascular and metabolic risk factors, (pituitary) hormones and bone markers.|After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).|||||||
2663913|NCT01546922|Secondary|Change in Quality of Life After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|Quality of life questionnaires have to be filled in by the participant at his/her home place and have to be returned by post.|After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).|||||||
2663914|NCT01546922|Primary|Change in Cognition After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.|"Cognitive domains to be tested: memory, executive functioning, attention and social cognition.~The psychological tests consist of oral and written questions or computer tasks.~Data is given as Z-scores based on normative data. Higher Z-scores represent a better performance."|After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).|The participants completing both study periods were analyzed|||Z-scores based on normative data.||Standard Deviation|Mean
2663915|NCT01546883|Primary|Percentage of Fibrosis|We will measure the change in percentage of fibrosis over a one-year period when drug is taken. We will calculate the results as percentage of fibrosis measured using MRI at 12 months minus the percentage of fibrosis measured using MRI at baseline to clarify if there is a decrease in fibrosis in the one year period.|MRI at baseline and MRI at 12 months post-enrollment|Data were not collected for the analysis population and therefore could not be summarized to include in this report.||||||
2668591|NCT01504971|Secondary|Association of Each Endoscopic Finding With pH Monitoring Result||1 month|||||||
2663916|NCT01546688|Secondary|Percentage of Responders During Last 28 Days of Maintenance Period|Seizure frequency was assessed by a seizure diary, maintained daily from Baseline, in which the subject recorded the occurrence of any seizure. A responder is a subject who had at least a 50 percent or greater reduction in the seizure frequency of all seizures during the last 28 days of the Maintenance Period compared to the Baseline Period seizure frequency. Due to the exploratory nature of the objective for efficacy and the truncated study size, analysis of efficacy was based on observed cases, without imputation for missing data. As a result, there are some variations in sample sizes for efficacy at different visits, depending on if particular efficacy variables were missing for particular visits.|Baseline and Month 4|Intent-to-Treat Population. Percentages are based on the number of subjects present in the Maintenance Phase.|||Percentage of Participants|||Number
2663917|NCT01546688|Secondary|Percent Change in Seizure Frequency From Baseline to the Last 28 Days of the Maintenance Period|Seizure frequency was assessed by a seizure diary, maintained daily from Baseline, in which the subject recorded the occurrence of any seizure.|Baseline and Month 4|Intent-to-Treat Population.|||Percent Change||Full Range|Median
2663918|NCT01546688|Primary|Change From Baseline in Bond and Lader Visual Analogue Scale (VAS) Mood Sub-Scores for Sedation by Visit During Titration and Maintenance Period|The Bond-Lader mood rating scale measured sedation, with scores ranging from 0 to 100. A high score reflects a high level of sedation.|Baseline, Week 4, Week 8, Week 12, Week 16|Intent-to-Treat Population|||Scores on a Scale||Standard Deviation|Mean
2663919|NCT01546688|Primary|Change From Baseline in CVST of the FePsy Test (Mean Reaction Time) by Visit During Titration and Maintenance Period|The Computer Visual Search Task (CVST) of the Ferrum Psyche (FePsy)measured cognition. A decrease from Baseline (negative change value) signifies an improvement in the mean reaction time of CVST.|Baseline, Week 4, Week 8, Week 12, Week 16|Intent-to-Treat Population: All randomized subjects who received at least one dose of study medication.|||Seconds||Standard Deviation|Mean
2663920|NCT01546675|Secondary|Prosthetic Evaluation Questionnaire (PEQ) - Residual Limb Health Subscale|The 6-item residual limb health scale includes items about the bothersome of sweating, smell, swelling, ingrown hairs, rashes and blisters. All items were scored using a 1 to 7 Likert scale average with lower scores indicated worse ratings and higher scores indicated better ratings. The scores for each item were added and the total score was the average of scores for all items, thus scores could range from 1 to 7.|After 4 weeks of home use (2 weeks for each socket style)||||units on a scale|||Number
2663921|NCT01546675|Primary|Degrees of Shoulder Displacement Within the Prosthetic Socket|A shoulder shrug task was achieved by pulling up on a strap attached to the load cell, which was mounted on the vertical face of the concrete pedestal. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)|After 4 weeks of home use (2 weeks for each socket style)||||degrees|||Number
2663922|NCT01546675|Primary|Degrees of Shoulder Internal Rotation Within the Prosthetic Socket|Isometric internal rotation was performed with the prosthetic elbow flexed to 90 degrees and shoulder in neutral position. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)|After 4 weeks of home use (2 weeks for each socket style)||||degrees|||Number
2663923|NCT01546675|Secondary|Prosthetic Evaluation Questionnaire (PEQ) - Utility Subscale|The 8-item utility subscale includes items related to prosthetic socket utility including: comfort, fit, ease of donning and doffing and feel on the residual limb. All items were scored using a 1 to 7 Likert scale average with lower scores indicated worse ratings and higher scores indicated better ratings. The scores for each item were added and the total score was the average of scores for all items, thus scores could range from 1 to 7.|after 2 weeks of home use of each socket type||||units on a scale|||Number
2663924|NCT01546675|Secondary|Trinity Amputations and Prosthetics Experience Satisfaction Scale (TAPES)|This 10 item scale includes items related to satisfaction with aspects of the prosthesis. It includes questions about extent of satisfaction regarding functional characteristics of the artificial limb: reliability, comfort, fit, and overall satisfaction, contentment with cosmetic characteristics of the device. Each item is rated on a 5 point scale from very dissatisfied to very satisfied. Scores are summed and the average of the 10 items are calculated. Higher scores indicate greater satisfaction. Scores range from 1-5.|After 4 weeks of home use (2 weeks for each socket style)||||units on a scale|||Number
2663925|NCT01546675|Primary|Degrees of Shoulder Abduction Within the Prosthetic Socket|Shoulder abduction was performed to the subject's maximum elevation. Skeletal and socket kinematics were calculated using the markerless auto-registration algorithm and X-Ray Reconstruction of Moving Morphology (XROMM)|After 4 weeks of home use (2 weeks for each socket style)|One male and one female with traumatic amputation at the transhumeral level.|||degrees|||Number
2663926|NCT01546649|Secondary|QT Interval Measured by 12-lead Electrocardiogram (ECG)|12-lead electrocardiography measurement was performed in supine position after 5 minutes at rest. Each measurement was recorded continuously for 10 seconds at the recording speed of 25 millimeter/second (mm/second).|Baseline, Hour 1, 3, 6 on Day 1, Day 29, 85, 169 and 337|Safety evaluation was conducted in the safety analysis set (SAS). Here ‘N’ represents evaluable baseline and post-baseline assessment population.|||millisecond (msec)||Standard Deviation|Mean
2663927|NCT01546649|Secondary|Serum Unchanged TAP-144 Level|This measure indicates the unchanged TAP-144 level in serum.|Baseline, Hour 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309 and 337|FAS included all randomized participants who had received at least a single dose of study treatment. Here ‘N’ represents evaluable baseline and post-baseline assessment population.|||nanogram per deciliter (ng/dL)||Standard Deviation|Mean
2663928|NCT01546649|Secondary|Distant Disease Free Survival (DDFS) Rate at Week 96|DDFS is defined as time from randomization to earliest day of onset the events, distant recurrence, secondary cancer [including breast cancer in the contralateral breast] and death. DDFS at week 96 was defined as the percentage calculated with Kaplan-Meier method, of participants did not experience any events at week 96 since the randomization.|Week 96|FAS included all randomized participants who had received at least a single dose of study treatment.|||percentage of participants|||Number
2663945|NCT01546623|Secondary|Time Course of Changes in Serum Luteinizing Hormone (LH)||From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||mIU/mL|Participants|Full Range|Median
2663929|NCT01546649|Secondary|Disease Free Survival (DFS) Rate at Week 96|DFS is defined as time from randomization to earliest day of onset the events, recurrence [including recurrence in the ipsilateral breast], secondary cancer [including breast cancer in the contralateral breast] and death. DFS at Week 96 was defined as the percentage, calculated with Kaplan-Meier method, of participants did not experience any events at Week 96 since the randomization.|Week 96|FAS included all randomized participants who had received at least a single dose of study treatment.|||percentage of participants|||Number
2663930|NCT01546649|Secondary|Concentration of Follicle Stimulating Hormone (FSH)|This measure indicates serum FSH concentration at baseline and post-baseline time points.|Baseline, Hour 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673|FAS included all randomized participants who had received at least a single dose of study treatment. Here ‘N’ represents evaluable baseline and post-baseline assessment population.|||mIU/mL||Full Range|Median
2663931|NCT01546649|Secondary|Concentration of Serum Luteinizing Hormone (LH)|This measure indicates serum LH concentration at baseline and post-baseline time points. It was measured in milli-international units per milliliter (mIU/mL).|Baseline, Hour 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673|FAS included all randomized participants who had received at least a single dose of study treatment. Here ‘N’ represents evaluable baseline and post-baseline assessment population.|||mIU/mL||Full Range|Median
2663932|NCT01546649|Secondary|Concentration of Serum E2|The measure indicates serum E2 concentration at baseline and post-baseline time points.|Baseline, Hour (hr) 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673|FAS included all randomized participants who had received at least a single dose of study treatment. Here ‘N’ represents evaluable baseline and post-baseline assessment population.|||pg/mL||Full Range|Median
2663933|NCT01546649|Primary|Percentage of Participants With Suppressive Effect of Serum Estradiol (E2) to Menopausal Level (=<30 pg/mL) From Week 4 Through Week 48|Comparison of both the treatment groups was done by assessing the suppressive effect on serum E2 concentration maintained at menopausal level (=<30pg/mL). Suppression rate was calculated as proportion of participants maintained at menopausal level.|Week 4 up to Week 48|Full analysis set (FAS) included all randomized participants who had received at least a single dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2663934|NCT01546636|Secondary|Postanesthesia Care Unit Length of Stay (Total Time)||Approximately 5 hours||||minutes||Full Range|Median
2663935|NCT01546636|Secondary|Number of Patients Experiencing Nausea and Vomiting|Assessed by recovery nurses|Postanesthesia care unit-first 2 hours||||participants|||Number
2663936|NCT01546636|Primary|Incidence of Cerebral Desaturation Events|Cerebral desaturation events were measured with near-infrared spectroscopy|Intraoperative-first 2 hours||||number of events|||Number
2663937|NCT01546623|Secondary|12-lead ECG||At 1 hour, week 24, and week 48 after administration|Safety evaluation was conducted in the safety analysis set (SAS), which includes all 160 patients who received the study drug [TAP-144-SR (&M) group: 81 patients, TAP-144-SR (3M) group: 79 patients|||msec||Standard Deviation|Mean
2663938|NCT01546623|Secondary|Serum Unchanged TAP-144 Level||From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||ng/dL||Standard Deviation|Mean
2663939|NCT01546623|Secondary|Bone Lesion Response|"Partially revised assessment based on the criteria for therapeutic effect from the General Rule for Clinical and Pathological Studies on Prostate Canter, 4th edition. Response is measured using bone scintigraphy. Increase in new (2 or more) bone lesion is considered as progression"|At Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||Percentage of participants|||Number
2663940|NCT01546623|Secondary|Soft Tissue Response|"Assessment in accordance with the criteria for therapeutic effect from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition. Soft tissue response was evaluated in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|At week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||Percentage of participants|||Number
2663941|NCT01546623|Secondary|Percentage of Participants With Progression by PSA (FAS)|"Evaluation according to the Criteria for therapeutic effect from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by PSA)"|From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||percentage of participants|Participants||Number
2663942|NCT01546623|Secondary|The Maximum Rate of Change in PSA Suppression (FAS)|"Evaluation according to the Criteria for therapeutic effect from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by PSA)"|From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||percent change||Full Range|Median
2663943|NCT01546623|Secondary|Time Course of Change Rate in Serum PSA (FAS)|"Evaluation according to the Criteria for therapeutic effect from the General Rule for Clinical Pathological Studies on Prostate Cancer, 4th edition (determination of therapeutic effect by prostate-specific antigen [PSA])"|From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||percent change||Full Range|Median
2663944|NCT01546623|Secondary|Time Course of Changes in Serum Follicle-stimulating Hormone (FSH)||From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||mIU/mL||Full Range|Median
2663946|NCT01546623|Secondary|Time Course of Changes in Serum Testosterone||From baseline to Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of open-label study drug) with both Baseline and a post-baseline value; last observation carried forward was used.|||ng/dL||Full Range|Median
2663947|NCT01546623|Primary|The Rate of Suppression of Serum Testosterone to Castrate Level|Comparison of the proportion of patients maintained at castration level (≤100 ng/dL)|From the start of study drug administration through Week 48|Full analysis set participants (all randomized participants who received at least 1 dose of study drug) was used.|||Participants|||Number
2663948|NCT01546519|Secondary|Apparent Non-renal Clearance (CLNR/F) of Vismodegib|Apparent Non-Renal Clearance (CLNR) describes the removal of vismodegib by organs other than the kidneys. This was a pre-specified PK parameter. However, due to minimal fluctuation of vismodegib concentrations at steady state, this parameter could not be determined.|Up to 8 days|PK population was the anticipated population for analysis. However, this outcome measure was not analyzed due to the minimal fluctuation of vismodegib concentrations at steady state.||||||
2663949|NCT01546519|Secondary|Apparent Clearance (CL/F) of Vismodegib|CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in liter/hour (L/hr). This was a pre-specified PK parameter. However, due to minimal fluctuation of vismodegib concentrations at steady state, this parameter could not be determined.|Up to 8 days|PK population was the anticipated population for analysis. However, this outcome measure was not analyzed due to the minimal fluctuation of vismodegib concentrations at steady state.||||||
2663950|NCT01546519|Secondary|Minimum Plasma Concentration (Cmin) of Vismodegib|Cmin is defined as the minimum observed plasma concentration of Vismodegib. This was a pre-specified PK parameter. However, due to minimal fluctuation of Vismodegib concentrations at steady state, this parameter could not be determined.|Up to 8 days|PK population was the anticipated population for analysis. However, this outcome measure was not analyzed due to the minimal fluctuation of vismodegib concentrations at steady state.||||||
2663951|NCT01546519|Secondary|Time to Maximum Plasma Concentration (Tmax) of Vismodegib|Tmax is the time to reach maximum plasma concentration of vismodegib. This was a pre-specified PK parameter. However, due to minimal fluctuation of Vismodegib concentrations at steady state, this parameter could not be determined.|Up to 8 days|PK population was the anticipated population for analysis. However, this outcome measure was not analyzed due to the minimal fluctuation of vismodegib concentrations at steady state.||||||
2663952|NCT01546519|Secondary|Amount of Vismodegib Excreted Into Urine in 24 Hours (Ae0-24hr)|The amount of total vismodegib excreted in urine over a 24-hr total interval (Ae0-24hr) was estimated.|24 hr total interval on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples. Participants available at particular time point for assessment were included in the analysis.|||milligrams/24 hour||Standard Deviation|Mean
2663953|NCT01546519|Secondary|Renal Clearance of Vismodegib|Renal clearance (CLR) is defined as the apparent total clearance of the drug from plasma after oral administration.|0, 0.5, 1, 2, 4, 8 and 24 hours postdose on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples. Participants available at particular time point for assessment were included in the analysis.|||Liter/hour||Standard Deviation|Mean
2663954|NCT01546519|Secondary|The Percentage of Dose of Vismodegib in 24-hour Total Urine|The percentage of dose vismodegib excreted in urine over a 24-hr total interval was estimated|24 hr total interval on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples. Participants available at particular time point for assessment were included in the analysis.|||% Dose Excreted in 24 hr||Standard Deviation|Mean
2663955|NCT01546519|Primary|The Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC[0-24hours]) Following Multiple Doses of Vismodegib|The steady state pharmacokinetic profile following oral administration of multiple doses of vismodegib included determining the area under the curve over the dosing interval (AUC[0-24 hours]). The AUC[0-24 hrs]) was determined by standard non-compartmental analysis using WinNonlin. Blood samples were collected at pre-dose and at 0.5, 1, 2, 4, 8 and 24 hours post-dose on Day 8 to estimate AUC(0-24 hrs).|Day 1, 2, 4 and 0, 0.5, 1, 2, 4, 8 and 24 hours postdose on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples|||Micromolar*hour||Standard Deviation|Mean
2663956|NCT01546519|Primary|Maximum Observed Plasma Concentration and Concentration at Steady-state Following Multiple Doses of Vismodegib|Maximum observed plasma Concentration (Cmax) & Concentration at steady-state (Css) following multiple doses of vismodegib (150 mg QD) were analyzed. At steady state the amount of drug administered (in a given time period) is equal to the amount of drug eliminated. Blood samples for assessing Cmax and Css for analysis were collected following multiple oral doses of vismodegib at pre-dose and at 0.5, 1, 2, 4, 8 and 24 hours post-dose on Day 8. From the plasma concentration-time curve, the PK parameter Cmax and Css were determined by standard non-compartmental analysis using WinNonlin|Day 1,2,4 and 0, 0.5, 1, 2, 4, 8 and 24 hours post dose on Day 8|Pharmacokinetic (PK) Population: A participant was considered evaluable for the PK analyses if he or she had a full profile of vismodegib samples|||micromolar||Standard Deviation|Mean
2663957|NCT01546454|Primary|Total to HDL Cholesterol Ratio||Entire Study||||Total to HDL Cholesterol Ratio||95% Confidence Interval|Mean
2663958|NCT01546402|Secondary|Change in the Visual Acuity|Change in the visual acuity as measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity scale (number of letters at 6 months - number of letters at baseline) The number of letters read on the ETDRS scale will be measured, with 0 being the worst and 35 being the best|Difference in number of letters read (6 months minus baseline)||||Number of letters on ETDRS scale||Standard Deviation|Mean
2663959|NCT01546402|Primary|Change in the Central Macular Thickness|The primary outcome is the change in the central macular thickness, either an increase or decrease, as measured by optical coherence tomography as compared to the preoperative thickness.|Baseline and 6 MONTHS||||Microns||Standard Deviation|Mean
2664115|NCT01545232|Primary|Coagulation as Indicated by Number of Participants With Reported Venous Thrombolic Events (VTE)|Blood samples were collected at time of ED admission and over time to determine the incidence of reported venous thrombolic events (VTE).|From time of ED admission, for up to 72 hours|Number of subjects who were randomized to each group|||participants|||Number
2663960|NCT01546285|Primary|Difference Between the B40 Monitor and Reference Device DINAMAP PRO1000 on NIBP Measurements|The primary endpoints are the difference in systolic, diastolic and mean blood pressure values between the B40 Monitor and PRO1000. The mean of the difference should be no more than 5mmHg and the standard deviation of the difference should be no more than 8mmHg per the AAMI SP-10 standard.|End of each blood pressure reading|66 subjects were enrolled. 64 subjects contributed data to the study. Subject 058 had a lateral difference of the reference diastolic blood pressure more than 10mmHg, and NIBP data was excluded from final analysis as specified in AAMI SP-10 standard. And Subject 046 had circulation issues and no data was collected.|||mmHg||Standard Deviation|Mean
2663961|NCT01546207|Secondary|Signal-Average ECG|Relationship between change in pre/post saECG and success of the step-wise ablation strategy|baseline and post-op day one after procedure|||||||
2663962|NCT01546207|Secondary|Procedural Safety|2) Procedural safety as defined by the number of complication within 1week associated with the procedure.|1 week post-op|||||||
2663963|NCT01546207|Secondary|ICD Interrogation|Chronic success will be defined as no recurrence of sustained VT or VT resulting in ICD therapies (ATP and/or ICD shocks) at 6 months follow-up as compared to baseline.|baseline and 6 months follow-up|||||||
2663964|NCT01546207|Primary|Catheter Ablation|The procedural efficacy as defined as acute success of a standardized step-wise approach for substrate-based catheter ablation of recurrent ventricular tachycardia in patients with coronary artery disease and prior ventricular tachycardia or appropriate therapy. Acute success will be defined as the ability to render VT non-inducible with a standardized complete stimulation protocol. catheter ablation - a medical procedure used to treat some types of arrhythmia|at time of catheter ablation procedure (intraoperative)|Given the small sample size, we did not analyze the data as there would be no statistical significance.||||||
2663965|NCT01546194|Primary|Overall Patient Satisfaction With the Same-day Consent Process-total Number of Questions Answered With a Score of 0 to 10 (on a 11-point Scale From 0=Strongly Disagree to 10=Strongly Agree).|Subjects will reply using a 11-point scale from 0=strongly disagree to 10=strongly agree.|First postoperative day||||units on a scale||Full Range|Median
2663966|NCT01546168|Secondary|Swallowing Impairment Score|Swallowing impairment during procedure - Scale from 0 (no impairment) to 4 (severe impairment).|during AF ablation procedure (intraoperative)|17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.|||units on a scale||Full Range|Mean
2663967|NCT01546168|Secondary|Temperature|Extent of temperature rise on the temperature monitoring probe|during AF ablation procedure (intraoperative)|17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.|||Celsius||Standard Deviation|Mean
2663968|NCT01546168|Secondary|Procedure Time|Procedure time and fluoroscopic imaging with barium contrast time|day 1, duration ofAF ablation procedure|17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.|||minutes||Standard Deviation|Mean
2663969|NCT01546168|Primary|Number of Participants With Presence of Esophageal Injury|The presence of esophageal injury as assessed by upper gastrointestinal endoscopy that is performed within 1 week of the procedure.|within 1 week of AF ablation procedure|17 roll-in patients and two pre-procedure withdrawals are removed from the analysis.|||Participants|||Count of Participants
2663970|NCT01546155|Primary|PET/MRI Brain Activation|"Simultaneously collect fMRI-PET data in humans to investigate the change between bold signal evoked by pressure pain and bold signal evoked by non-painful pressure.~The PET analyses generates one value per 120 minutes. This value is compared to the other 120 minute scan PET value in order to reflect the change."|day one||||percentage BOLD signal change||Standard Deviation|Mean
2663971|NCT01546142|Secondary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat population; missing values were imputed using a multiple imputation process.|||units on a scale||Standard Deviation|Mean
2663972|NCT01546142|Secondary|Percentage of Participants With a Magnetic Resonance Imaging (MRI) Response|An MRI responder is a participant who exhibited at least a 10% reduction in submental fat volume as measured by MRI from Baseline to 12 weeks after last treatment. Magnetic resonance imaging was evaluated in a subset of participants at selected centers.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|The ITT-MRI population consisted of all randomized participants who participated in the MRI cohort and had evaluable Baseline MRI data. A multiple imputation process was used.|||percentage of participants|||Number
2663973|NCT01546142|Primary|Percentage of Participants Who Achieved a Composite 2-grade Response|"A composite 2-grade response is defined as at least a 2-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat population; missing values were imputed using a multiple imputation process.|||percentage of participants|||Number
2663989|NCT01546038|Secondary|Ratios of mRNA Levels to Baseline at Phase 2 Fit - Induction Cycle 1/Day 3|Whole blood mRNA analyses were performed on 21 mRNA candidates. Values showing statistically significant, ≥2-fold differences compared with baseline are reported here. CDKN1A: cyclin-dependent kinase inhibitor 1A; SMO: mRNA encoding the glasdegib target Smoothened; PTCH2: Patched 2; MYCN: Neuroblastoma Myc oncogene.|Baseline (Induction Cycle 1/Day -3 pre-dose); Induction Cycle 1/Day 3, 1 Hour Post dose|PD analysis set: all enrolled participants in Phase 2 Fit who received at least 1 dose of glasdegib, had at least 1 PD parameter with a baseline and an adequate post treatment assessment.|||ratio||Full Range|Median
2663974|NCT01546142|Primary|Percentage of Participants Who Achieved a Composite 1-grade Response|"A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat (ITT) population; missing values were imputed using a multiple imputation process.|||percentage of participants|||Number
2663975|NCT01546038|Secondary|Number of Participants With Treatment-emergent AEs Categorized by Seriousness at Phase 2 Fit and Unfit|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not necessarily had a causal relationship with the treatment or usage. Treatment Emergent AEs were those with initial onset or increasing in severity after the first dose of study medication and occurred within 28 days post last dose. An serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect.|4 years|Safety analysis set: all enrolled participants who received at least 1 dose of any of the study medications for each drug combination.|||Participants|||Number
2663976|NCT01546038|Secondary|Number of Participants With Treatment-emergent AEs at Phase 2 Fit and Unfit (Treatment-related)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not necessarily had a causal relationship with the treatment or usage. Treatment Emergent AEs were those with initial onset or increasing in severity after the first dose of study medication and occurred within 28 days post last dose. Treatment-related AEs were AEs related to glasdegib and/or backbone chemotherapy. AEs were graded by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 : Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.|4 years|Safety analysis set: all enrolled participants who received at least 1 dose of any of the study medications for each drug combination.|||Participants|||Number
2663977|NCT01546038|Secondary|Number of Participants With Treatment-emergent AEs at Phase 2 Fit and Unfit (All Causality)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not necessarily had a causal relationship with the treatment or usage. Treatment Emergent AEs were those with initial onset or increasing in severity after the first dose of study medication and occurred within 28 days post last dose. AEs were graded by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 : Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.|4 years|Safety analysis set: all enrolled participants who received at least 1 dose of any of the study medications for each drug combination.|||Participants|||Number
2663978|NCT01546038|Secondary|Number of Participants With Treatment-emergent AEs Categorized by Seriousness at Phase 1B|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not necessarily had a causal relationship with the treatment or usage. Treatment Emergent AEs were those with initial onset or increasing in severity after the first dose of study medication and occurred within 28 days post last dose. An serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect.|4 years|Safety analysis set: all enrolled participants who received at least 1 dose of any of the study medications for each drug combination.|||Participants|||Number
2663979|NCT01546038|Secondary|Number of Participants With Treatment-emergent AEs at Phase 1B (Treatment-related)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not necessarily had a causal relationship with the treatment or usage. Treatment Emergent AEs were those with initial onset or increasing in severity after the first dose of study medication and occurred within 28 days post last dose. Treatment-related AEs were AEs related to glasdegib and/or backbone chemotherapy. AEs were graded by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 : Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.|4 years|Safety analysis set: all enrolled participants who received at least 1 dose of any of the study medications for each drug combination.|||Participants|||Number
2663980|NCT01546038|Secondary|Number of Participants With Treatment-emergent Adverse Events (AEs) at Phase 1B (All Causality)|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not necessarily had a causal relationship with the treatment or usage. Treatment Emergent AEs were those with initial onset or increasing in severity after the first dose of study medication and occurred within 28 days post last dose. AEs were graded by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 : Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.|4 years|Safety analysis set: all enrolled participants who received at least 1 dose of any of the study medications for each drug combination.|||Participants|||Number
2664021|NCT01546038|Secondary|Tmax of Decitabine in Participants Receiving Glasdegib and Decitabine at Phase 1B on Cycle 1/Day 1 and Cycle 1/Day 2||Pre-dose, 0.5 hour from start of infusion, 1 hour (at end of infusion) and 2, 3 and 4 hours from start of infusion on Cycle 1/Day 1 and Cycle 1/Day 2|PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.|||Hours||Full Range|Median
2663981|NCT01546038|Secondary|Number of Participants With Corrected QT Interval Using Fridericia's Formula (QTcF) Values Meeting Predefined Criteria at Phase 2 Fit and Unfit|Maximum absolute values and increases from baseline were summarized for QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula). Number of participants with QTcF meeting the following criteria is presented:QTcF interval:<450 msec; QTcF interval: 450 to <480 msec; QTcF interval: 480 to <500 msec; QTcF interval >=500 msec; QTcF interval increase from baseline: <30 msec; QTcF interval increase from baseline: 30 to <60 msec; QTcF interval increase from baseline >=60 msec. End of treatment in the time frame were defined as: maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first.|1 year|QTc analysis set: all participants enrolled in the study having at least 1 ECG assessment after receiving at least 1 dose of glasdegib.|||Participants|||Number
2663982|NCT01546038|Secondary|Number of Participants With Corrected QT Interval Using Fridericia's Formula (QTcF) Values Meeting Predefined Criteria at Phase 1B|Maximum absolute values and increases from baseline were summarized for QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula). Number of participants with QTcF meeting the following criteria is presented: QTcF interval:<450 msec; QTcF interval: 450 to <480 msec; QTcF interval: 480 to <500 msec; QTcF interval >=500 msec; QTcF interval increase from baseline: <30 msec; QTcF interval increase from baseline: 30 to <60 msec; QTcF interval increase from baseline >=60 msec. Arms in the time frame description are defined as: Arm A, Glasdegib +LDAC; Arm B, Glasdegib + Decitabine; Arm C, Glasdegib + Cytarabine/Daunorubicin. End of treatment in the time frame were defined as: maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first.|1 year|QTc analysis set: all participants enrolled in the study having at least 1 ECG assessment after receiving at least 1 dose of glasdegib.|||Participants|||Number
2663983|NCT01546038|Secondary|Ratios of mRNA Levels Associated With Best Overall Response at Phase 2 Unfit|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. Whole blood mRNA analyses were performed on 21 mRNA candidates. Ratios of mRNA level to baseline showing statistically significant correlation with clinical response are reported. Ratios of mRNA levels to baseline statistically significant associated with best overall response was only seen for MYCN (Neuroblastoma Myc oncogene) at Cycle 1/Day 1.|Baseline (Cycle 1/Day 1 pre-dose); Cycle 1/Day 1, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 2 Unfit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||ratio||Full Range|Median
2663984|NCT01546038|Secondary|Ratios of mRNA Levels to Baseline Associated With Best Overall Response at Phase 2 Fit|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. Whole blood mRNA analyses were performed on 21 mRNA candidates. Ratios of mRNA level to baseline showing statistically significant correlation with clinical response are reported.|Baseline (Induction Cycle 1/Day -3 pre-dose); End of Treatment (maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first, an average of 1 year)|PD analysis set: all enrolled participants in Phase 2 Fit who received at least 1 dose of glasdegib, had at least 1 PD parameter with a baseline and an adequate post treatment assessment.|||ratio||Full Range|Median
2663985|NCT01546038|Secondary|Baseline mRNA Levels Associated With Best Overall Response at Phase 2 Unfit|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. Whole blood mRNA analyses were performed on 21 mRNA candidates. Baseline mRNA level showing statistically significant correlation with clinical response are reported. FOXM1: Forkhead box M1; PTCH1: Patched 1.|Baseline (Cycle 1/Day 1 pre-dose)|PD analysis set:all enrolled participants in Phase 2 Unfit who received at least 1 dose of glasdegib, had at least 1 PD parameter with a baseline and an adequate post treatment assessment.|||Normalized expression units||Full Range|Median
2663986|NCT01546038|Secondary|Baseline mRNA Levels Associated With Best Overall Response at Phase 2 Fit|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. Whole blood mRNA analyses were performed on 21 mRNA candidates. Baseline mRNA level showing statistically significant correlation with clinical response are reported. Baseline mRNA levels statistically significant associated with best overall response was only seen for CCND2 (G1/S-Specific Cyclin D2).|Baseline (Induction Cycle 1/Day -3 pre-dose)|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||Normalized expression units||Full Range|Median
2663987|NCT01546038|Secondary|Ratios of mRNA Levels to Baseline at Phase 2 Unfit - End of Treatment|Whole blood mRNA analyses were performed on 21 mRNA candidates. Only the analytes showing statistically significant change from baseline are reported here.|Baseline (Cycle 1/Day 1 pre-dose); End of Treatment (maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first, an average of 1 year)|PD analysis set:all enrolled participants in Phase 2 Unfit who received at least 1 dose of glasdegib, had at least 1 PD parameter with a baseline and an adequate post treatment assessment.|||ratio||Full Range|Median
2663988|NCT01546038|Secondary|Ratios of mRNA Levels to Baseline at Phase 2 Fit - End of Treatment|Whole blood mRNA analyses were performed on 21 mRNA candidates. Selected values showing statistically significant differences compared with baseline are reported here. CCND2:G1/S-Specific Cyclin D2; MSI2: Musashi RNA Binding Protein 2; PTCH2: Patched 2.|Baseline (Induction Cycle 1/Day -3 pre-dose); End of Treatment (maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first, an average of 1 year)|PD analysis set: all enrolled participants in Phase 2 Fit who received at least 1 dose of glasdegib, had at least 1 PD parameter with a baseline and an adequate post treatment assessment.|||ratio||Full Range|Median
2663990|NCT01546038|Secondary|Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Unfit - End of Treatment|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. Selected data of analyte for which the serum level showed statistically significant correlation with clinical response are reported.|End of Treatment (maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first, an average of 1 year)|PD analysis set: all enrolled participants in the Phase 2 Unfit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
2663991|NCT01546038|Secondary|Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Unfit - Cycle 1/Day 1|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. Selected data of analytes for which the serum level showed statistically significant correlation with clinical response are reported.|Cycle 1/Day 1, 1 Hour Post-dose|PD analysis set: all enrolled participants in the Phase 2 Unfit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
2663992|NCT01546038|Secondary|Baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Unfit|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. The data of analytes for which the serum level showed statistically significant correlation with clinical response are reported.|Baseline (Cycle 1/Day 1 pre-dose)|PD analysis set: all enrolled participants in the Phase 2 Unfit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
2663993|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 2 Unfit - Cycle 1/Day 10|Serum levels were determined for 38 circulating proteins. Selected values showing statistically significant differences compared with baseline are reported here. ITAC (Interferon-inducible T-cell α chemoattractant) level in LDAC alone arm at Cycle 1/Day 10 exhibited non-significant change from baseline but similar trends as in Glasdegib 100 mg+LDAC arm.|Cycle 1/Day 10, Pre-dose|PD analysis set: all enrolled participants in the Phase 2 Unfit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
2663994|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 2 Unfit - Cycle 1/Day 1|Serum levels were determined for 38 circulating proteins. Selected value showing statistically significant difference compared with baseline is reported here.|Cycle 1/Day 1, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 2 Unfit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
2663995|NCT01546038|Secondary|Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Fit - End of Treatment|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. Selected data of analytes for which the serum level showed statistically significant correlation with clinical response are reported.|End of Treatment (maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first, an average of 1 year)|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
2663996|NCT01546038|Secondary|Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Fit - Induction Cycle 1/Day 10|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. Selected data of analyte for which the serum level showed statistically significant correlation with clinical response are reported.|Induction Cycle 1/Day 10, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Mean
2663997|NCT01546038|Secondary|Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Fit - Induction Cycle 1/Day 3|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. Selected data of analyte for which the serum level showed statistically significant correlation with clinical response are reported.|Induction Cycle 1/Day 3, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Mean
2663998|NCT01546038|Secondary|Baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 2 Fit|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. Selected data of analyte for which the serum level showed statistically significant correlation with clinical response are reported.|Baseline (Induction Cycle 1/Day -3 pre-dose)|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
2663999|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 2 Fit - End of Treatment|Serum levels were determined for 38 circulating proteins. Selected values showing statistically significant difference compared with baseline are reported here.|End of Treatment (maximum of 12 cycles from start of therapy or until disease progression or relapse, participant refusal or unacceptable toxicity occurred, whichever came first, an average of 1 year)|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
2664000|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 2 Fit - Consolidation Cycle 1/Day 10|Serum levels were determined for 38 circulating proteins. Selected values showing statistically significant difference compared with baseline are reported here.|Consolidation Cycle 1/Day 10, Pre-dose|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
2664001|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 2 Fit - Consolidation Cycle 1/Day 1|Serum levels were determined for 38 circulating proteins. Selected values showing statistically significant difference compared with baseline are reported here.|Consolidation Cycle 1/Day 1, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
2664002|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 2 Fit - Induction Cycle 1/Day 10|Serum levels were determined for 38 circulating proteins. Selected values showing statistically significant difference compared with baseline are reported here.|Induction Cycle 1/Day 10, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
2664003|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 2 Fit - Induction Cycle 1/Day 3|Serum levels were determined for 38 circulating proteins. Selected values showing statistically significant difference compared with baseline are reported here.|Induction Cycle 1/Day 3, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 2 Fit portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
2664004|NCT01546038|Secondary|Number of Participants With Disease-related Gene Mutations at Phase 2 Fit and Unfit|Peripheral blood and bone marrow aspirate were collected for baseline mutational analyses. Genetic abnormalities frequently associated with AML were analyzed. These genetic abnormalities included known mutations in the genes NPM1, CEBPA, FLT3, RUNX1, IDH1, IDH2, KIT, K Ras, N Ras and WT1. Additional genes with mutations known to be associated with AML and MDS such as TET2 and DNMT3A were also evaluated.|Baseline (Induction Cycle 1/Day -3 pre-dose for Phase 2 Fit; Cycle 1/Day 1 pre-dose for Phase 2 Unfit)|PD analysis set: all enrolled participants in the Phase 2 Fit and Unfit portion who received at least 1 dose of glasdegib; responders and non-responders in each arm with at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||Participants|||Number
2664005|NCT01546038|Secondary|Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 1B - Induction Cycle 1/Day 3|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. The data of analytes for which the serum level showed statistically significant correlation with clinical response are reported. Post-baseline levels statistically significant associated with best overall response was only seen for SDF-1 (Stromal cell-derived factor 1) at Induction Cycle 1/Day 3.|Induction Cycle 1/Day 3, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 1B portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
2664006|NCT01546038|Secondary|Post-baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 1B - Induction Cycle 1/Lead-In|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. The data of analytes for which the serum level showed statistically significant correlation with clinical response are reported. Post-baseline levels statistically significant associated with best overall response was only seen for MMP-3 (Matrix metalloproteinase-3) at Induction Cycle 1/Lead-in.|Induction Cycle 1/Lead-in, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 1B portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||ng/mL||Full Range|Median
2664007|NCT01546038|Secondary|Baseline Levels of Serum Circulating Protein Analytes Associated With Best Overall Response at Phase 1B|Responders were AML participants who achieved CR, CRi, MLFS, PR or PRi based on investigator-reported best overall response and MDS participants who achieved CR, mCR, PR or SD based on investigator-reported best overall response. A total of 38 proteins were analyzed. The data of analytes for which the serum level showed statistically significant correlation with clinical response in Arm C are reported. Baseline levels statistically associated with best overall response was only seen in SDF-1 (stromal cell-derived factor 1) in glasdegib+cytarabine/daunorubicin arm.|Baseline (Cycle 1/Day 1 pre-dose for Glasdegib + LDAC and Glasdegib + Decitabine Arms; Induction Cycle 1/Day -3 pre-dose for Glasdegib +Cytarabine/Daunorubicin Arm)|PD analysis set: all enrolled participants in the Phase 1B portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
2664022|NCT01546038|Secondary|Cmax of Decitabine in Participants Receiving Glasdegib and Decitabine at Phase 1B on Cycle 1/Day 1 and Cycle 1/Day 2||Pre-dose, 0.5 hour from start of infusion, 1 hour (at end of infusion) and 2, 3 and 4 hours from start of infusion on Cycle 1/Day 1 and Cycle 1/Day 2|PK concentration population: all treated participants who had at least 1 concentration of any of the study drugs.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2664008|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 1B - Induction Cycle 1/Day 10|Serum levels were determined for 38 circulating proteins. Values showing statistically significant, ≥2-fold difference compared with baseline are reported here.|Induction Cycle 1/Day 10, 1 Hour Post dose|PD analysis set: all enrolled participants in the Phase 1B portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
2664009|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 1B - Induction Cycle 1/Day 3|Serum levels were determined for 38 circulating proteins. Values showing statistically significant, ≥2-fold difference compared with baseline are reported here. Statistically significant, >=2-fold baseline difference was only seen for MMP-3 (Matrix metalloproteinase-3) at Induction Cycle 1/Day 3.|Induction Cycle 1/Day 3, 1 Hour Post dose|Pharmacodynamic (PD) analysis set: all enrolled participants in the Phase 1B portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
2664010|NCT01546038|Secondary|Serum Levels of Circulating Protein Analytes at Phase 1B - Baseline|Serum levels were determined for 38 circulating proteins. Values showing statistically significant, ≥2-fold difference compared with baseline are reported here.|Baseline (Induction Cycle 1/Day -3 pre-dose)|Pharmacodynamic (PD) analysis set: all enrolled participants in the Phase 1B portion who received at least 1 dose of glasdegib, and had at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||pg/mL||Full Range|Median
2664011|NCT01546038|Secondary|Number of Participants With Disease-related Gene Mutations at Phase 1B|Peripheral blood and bone marrow aspirate were collected for baseline mutational analyses. Genetic abnormalities frequently associated with AML were analyzed. These genetic abnormalities included known mutations in the genes NPM1, CEBPA, FLT3, RUNX1, IDH1, IDH2, KIT, K Ras, N Ras and WT1. Additional genes with mutations known to be associated with AML and MDS such as TET2 and DNMT3A were also evaluated.|Baseline (Cycle 1/Day 1 pre-dose for Glasdegib + LDAC and Glasdegib + Decitabine Arms; Induction Cycle 1/Day -3 pre-dose for Glasdegib +Cytarabine/Daunorubicin Arm)|Pharmacodynamic (PD) analysis set: all enrolled participants in the Phase 1B portion who received at least 1 dose of glasdegib; responders and non-responders in each arm with at least 1 PD parameter from the corresponding assay sample with a baseline and an adequate post treatment assessment.|||Participants|||Number
2664012|NCT01546038|Secondary|AUCtau of Glasdegib in Participants Receiving Glasdegib and LDAC at Phase 2 Unfit on Cycle 1/Day 10||Pre-dose, 1, 2, 4, and 6 hour post-dose on Cycle 1/Day 10|Dose compliant, non CYP3A4 group: dose compliant group participants who did not have administration of any strong or moderate CYP3A4 inhibitors.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2664013|NCT01546038|Secondary|Tmax of Glasdegib in Participants Receiving Glasdegib and LDAC at Phase 2 Unfit on Cycle 1/Day 10||Pre-dose, 1, 2, 4, and 6 hour post-dose on Cycle 1/Day 10|Dose compliant, non CYP3A4 group: dose compliant group participants who did not have administration of any strong or moderate CYP3A4 inhibitors.|||Hours||Full Range|Median
2664014|NCT01546038|Secondary|Cmax of Glasdegib in Participants Receiving Glasdegib and LDAC at Phase 2 Unfit on Cycle 1/Day 10||Pre-dose, 1, 2, 4, and 6 hour post-dose on Cycle 1/Day 10|Dose compliant, non CYP3A4 group: dose compliant group participants who did not have administration of any strong or moderate CYP3A4 inhibitors.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2664015|NCT01546038|Secondary|Pre-dose Plasma Concentration (Ctrough) of Glasdegib in Phase 2 Fit on Induction Cycle 1/Day 10||Pre-dose, 1 and 4 hours post-dose on Induction Cycle 1/Day 10|Dose compliant, non CYP3A4 group: dose compliant group participants who did not have administration of any strong or moderate CYP3A4 inhibitors.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2664016|NCT01546038|Secondary|AUCtau of Daunorubicin and Daunorubicinol in Participants Receiving Glasdegib and Cytarabine/Daunorubicin at Phase 1B on Induction Cycle 1/Day 3|Daunorubicinol is the major metabolite of daunorubicin, which has anti-neoplastic activity. AUCtau values of daunorubicin and daunorubicinol are reported.|Pre-dose, 0.25, 0.5, 1, 4, 6, 24 hours post administration of daunorubicin on Induction Cycle 1/Day 3|PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2664017|NCT01546038|Secondary|Tmax of Daunorubicin and Daunorubicinol in Participants Receiving Glasdegib and Cytarabine/Daunorubicin at Phase 1B on Induction Cycle 1/Day 3|Daunorubicinol is the major metabolite of daunorubicin, which has anti-neoplastic activity. Tmax values of daunorubicin and daunorubicinol are reported.|Pre-dose, 0.25, 0.5, 1, 4, 6, 24 hours post administration of daunorubicin on Induction Cycle 1/Day 3|PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.|||Hours||Full Range|Median
2664018|NCT01546038|Secondary|Cmax of Daunorubicin and Daunorubicinol in Participants Receiving Glasdegib and Cytarabine/Daunorubicin at Phase 1B on Induction Cycle 1/Day 3|Daunorubicinol is the major metabolite of daunorubicin, which has anti-neoplastic activity. Cmax values of daunorubicin and daunorubicinol are reported.|Pre-dose, 0.25, 0.5, 1, 4, 6, 24 hours post administration of daunorubicin on Induction Cycle 1/Day 3|PK concentration population: all treated participants who had at least 1 concentration of any of the study drugs.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2664019|NCT01546038|Secondary|AUCtau of Cytarabine and Ara-U in Participants Receiving Glasdegib and Cytarabine/Daunorubicin at Phase 1B on Induction Cycle 1/Day 3|Ara-U is the major metabolite of cytarabine. LDAC (low dose cytarabine) is rapidly degraded to the stable metabolite Ara-U, levels of both cytarabine and Ara-U were reported.|Pre-dose, 6 and 24 hours post start of cytarabine infusion on Induction Cycle 1/Day 3|PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2664020|NCT01546038|Secondary|AUCinf of Decitabine in Participants Receiving Glasdegib and Decitabine at Phase 1B on Cycle 1/Day 1 and Cycle 1/Day 2||Pre-dose, 0.5 hour from start of infusion, 1 hour (at end of infusion) and 2, 3 and 4 hours from start of infusion on Cycle 1/Day 1 and Cycle 1/Day 2|PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2664116|NCT01545232|Primary|30-day Mortality||First 30 days after ED admission|Number of subjects enrolled into each group.|||participants|||Number
2664023|NCT01546038|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of LDAC and Ara-U in Participants Receiving Glasdegib and LDAC at Phase 1B on Cycle 1/Day 2 and Cycle 1/Day 10|Ara-U is the major metabolite of cytarabine. LDAC (low dose cytarabine) is rapidly degraded to the stable metabolite Ara-U. Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) levels of both LDAC and Ara-U were reported.|Pre-dose, 0.25, 0.5, 1, 2, 4 and 6 hours post-dose on Cycle 1/Day 2 and Cycle 1/Day 10|PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2664024|NCT01546038|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to Infinity (AUCinf) of LDAC in Participants Receiving Glasdegib and LDAC at Phase 1B on Cycle 1/Day 2 and Cycle 1/Day 10||Pre-dose, 0.25, 0.5, 1, 2, 4 and 6 hours post-dose on Cycle 1/Day 2 and Cycle 1/Day 10|PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2664025|NCT01546038|Secondary|Tmax of LDAC and Ara-U in Participants Receiving Glasdegib and LDAC at Phase 1B on Cycle 1/Day 2 and Cycle 1/Day 10|Ara-U is the major metabolite of cytarabine. LDAC (low dose cytarabine) is rapidly degraded to the stable metabolite Ara-U, Tmax levels of both LDAC and Ara-U were reported.|Pre-dose, 0.25, 0.5, 1, 2, 4 and 6 hours post-dose on Cycle 1/Day 2 and Cycle 1/Day 10|PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.|||Hours||Full Range|Median
2664026|NCT01546038|Secondary|Cmax of LDAC and Ara-U in Participants Receiving Glasdegib and LDAC at Phase 1B on Cycle 1/Day 2 and Cycle 1/Day 10|Ara-U is the major metabolite of cytarabine. LDAC (low dose cytarabine) is rapidly degraded to the stable metabolite Ara-U, Cmax levels of both LDAC and Ara-U were reported.|Pre-dose, 0.25, 0.5, 1, 2, 4 and 6 hours post-dose on Cycle 1/Day 2 and Cycle 1/Day 10|PK concentration population: all treated participants who had at least 1 concentration of any of the study drugs.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2664027|NCT01546038|Secondary|AUCtau of Glasdegib in Participants Receiving Glasdegib and Cytarabine/Daunorubicin at Phase 1B on Induction Cycle 1/Day 3 and Day 10||Pre-dose, 0.5, 1, 6 and 24 hours post-dose on Induction Cycle 1/Day 3; pre-dose, 0.5, 1, 4, 6 and 24 hours post-dose on Induction Cycle 1/Day 10|Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the “dose compliant” group.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2664028|NCT01546038|Secondary|Tmax of Glasdegib in Participants Receiving Glasdegib and Cytarabine/Daunorubicin at Phase 1B on Induction Cycle 1/Day 3 and Day 10||Pre-dose, 0.5, 1, 6 and 24 hours post-dose on Induction Cycle 1/Day 3; pre-dose, 0.5, 1, 4, 6 and 24 hours post-dose on Induction Cycle 1/Day 10|Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the “dose compliant” group.|||Hours||Full Range|Median
2664029|NCT01546038|Secondary|Cmax of Glasdegib in Participants Receiving Glasdegib and Cytarabine/Daunorubicin at Phase 1B on Induction Cycle 1/Day 3 and Day 10||Pre-dose, 0.5, 1, 6 and 24 hours post-dose on Induction Cycle 1/Day 3; pre-dose, 0.5, 1, 4, 6 and 24 hours post-dose on Induction Cycle 1/Day 10|Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the “dose compliant” group.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2664030|NCT01546038|Secondary|AUCtau of Glasdegib in Participants Receiving Glasdegib and Decitabine at Phase 1B on Cycle 1/Day 10 and Cycle 2/Day 1||Pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post-dose on Cycle 1/Day 10; pre-dose, 0.5, 1, 2, 6 and 24 hours post-dose on Cycle 2/Day 1|Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the “dose compliant” group.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2664031|NCT01546038|Secondary|Tmax of Glasdegib in Participants Receiving Glasdegib and Decitabine at Phase 1B on Cycle 1/Day 10 and Cycle 2/Day 1||Pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post-dose on Cycle 1/Day 10; pre-dose, 0.5, 1, 2, 6 and 24 hours post-dose on Cycle 2/Day 1|Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the “dose compliant” group.|||Hours||Full Range|Median
2664032|NCT01546038|Secondary|Cmax of Glasdegib in Participants Receiving Glasdegib and Decitabine at Phase 1B on Cycle 1/Day 10 and Cycle 2/Day 1||Pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post-dose on Cycle 1/Day 10; pre-dose, 0.5, 1, 2, 6 and 24 hours post-dose on Cycle 2/Day 1|Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the “dose compliant” group.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2664033|NCT01546038|Secondary|Area Under the Plasma Concentration-time Profile From Time 0 to Dosing Interval (AUCtau) of Glasdegib in Participants Receiving Glasdegib and LDAC at Phase 1B on Cycle 1/Day 10 and Cycle 1/Day 21||Pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post-dose on Cycle 1/Day 10 and Cycle 1/Day 21|Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the “dose compliant” group.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2664034|NCT01546038|Secondary|Time to Cmax (Tmax) of Glasdegib in Participants Receiving Glasdegib and LDAC at Phase 1B on Cycle 1/Day 10 and Cycle 1/Day 21||Pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post-dose on Cycle 1/Day 10 and Cycle 1/Day 21|Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the “dose compliant” group.|||Hours||Full Range|Median
2664035|NCT01546038|Secondary|Maximum Observed Plasma Concentration (Cmax) of Glasdegib in Participants Receiving Glasdegib and LDAC at Phase 1B on Cycle 1/Day 10 and Cycle 1/Day 21||Pre-dose, 0.5, 1, 2, 4, 6 and 24 hours post-dose on Cycle 1/Day 10 and Cycle 1/Day 21|Dose compliant group:Participants who had at least 4 days of uninterrupted dosing for a multiple dose PK assessment were considered to be at steady state,part of the “dose compliant” group.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2664055|NCT01545817|Secondary|Overall Survival of Everolimus (OSE)|Time from first everolimus dose until death due to any cause|Throughout the study period, up to 4 years|ITT|||months||95% Confidence Interval|Median
2664036|NCT01546038|Secondary|Percentage of Participants With Disease-specific Efficacy for Myelodysplastic Syndrome (MDS) at Phase 2 Fit and Unfit|For all MDS participants, disease specific efficacy measures included: CRi (bone marrow showing <5% myeloblasts with platelets <100,000/mcL or neutrophils <1000/mcL, including confirmed and unconfirmed responses); PR (repeat bone marrow myeloblasts showing decreased by >= 50% decrease but still >5%, peripheral blood showing neutrophils >= 1,000/mcL, platelets >= 100,000/mcL and Hgb>=11g/dL; including confirmed and unconfirmed responses); SD (including confirmed and unconfirmed responses, failure to achieve PR and no evidence of progression for >8 weeks); marrow complete response (mCR) (bone marrow showing <=5% myeloblasts and decreased by >= 50%), partial cytogenetic response (>=50% reduction of chromosomal abnormality) and complete cytogenetic response (CRc) (disappearance of chromosomal abnormality with no appearance of now ones).|4 years|MDS participants in the Full analysis set: all enrolled participants of Phase 2 Fit arm who received at least 1 dose of study medication, and all randomized participants of Phase 2 Unfit arm.|||Percentage of participants||80% Confidence Interval|Number
2664037|NCT01546038|Secondary|Percentage of Participants With Disease-specific Efficacy for Acute Myeloid Leukemia (AML) at Phase 2 Fit and Unfit|AML participants,disease specific efficacy measures included:CRi;Morphologic Leukemia Free State(MLFS)(bone marrow<5%myeloblasts with spicules and no blasts with auer rods,neutrophils<1000/mcL and platelets<100,000/mcL);partial remission(PR)(bone marrow myeloblasts decrease to 5-25&>=50%decrease from start, neutrophils>=1000/mcL, platelets>=100,000/mcL);PR with incomplete blood count recovery(PRi)(bone marrow myeloblasts decrease to 5-25&>=50%decrease from start,neutrophils<1000/mcL or platelets<100,000/mcL);minor response(MR)(bone marrow myeloblasts decrease to>=25% from start);stable disease(SD)(bone marrow myeloblasts stable+/-25% from screening value);cytogenetic complete response(CRc)(bone marrow<5%myeloblasts, neutrophils>1000/mcL, platelets>100,000/mcL and normal cytogenetics),molecular complete response(CRm)(bone marrow<5%myeloblasts, neutrophils>1000/mcL, platelets>100,000/mcL and molecular-negative).|4 years|AML participants in the Full analysis set: all enrolled participants of Phase 2 Fit arm who received at least 1 dose of study medication, and all randomized participants of Phase 2 Unfit arm.|||Percentage of participants||80% Confidence Interval|Number
2664038|NCT01546038|Secondary|Percentage of Participants With Complete Response (CR) at Phase 2 Unfit|For AML participants:CR were those with repeat bone marrow showing <5% myeloblasts,spicules present and no Auer rods, peripheral blood showing neutrophils>=1000/mcL and platelets>=100,000/mcL, transfusion independent and no extramedullary disease. For MDS participants:CR were those with repeat bone marrow showing <=5% myeloblasts, peripheral blood showing neutrophils>=1000/mcL, platelets>=100,000/mcL, 0% blast and hemoglobin (Hgb)>= 11 g/dL, normal maturation of all cell lines.|4 years|Full analysis set: all randomized participants of Phase 2 Unfit arm.|||Percentage of participants||80% Confidence Interval|Number
2664039|NCT01546038|Secondary|Percentage of Participants With CR / Complete Response With Incomplete Blood Count Recovery (CRi) at Phase 1B|For AML participants:CR were those with repeat bone marrow showing <5% myeloblasts,spicules present and no Auer rods, peripheral blood showing neutrophils>=1000/mcL and platelets>=100,000/mcL, transfusion independent and no extramedullary disease. For MDS participants:CR were those with repeat bone marrow showing <=5% myeloblasts, peripheral blood showing neutrophils>=1000/mcL, platelets>=100,000/mcL, 0% blast and hemoglobin (Hgb)>= 11 g/dL, normal maturation of all cell lines.For AML and MDS participants, complete response with incomplete blood count recovery(CRi)were those with repeat bone marrow showing <5% myeloblasts with either platelets or neutrophils not recovered (platelets <100,000/mcL or neutrophils <1000/mcL).|4 years|Full analysis set: all enrolled participants of Phase 1B portion who received at least 1 dose of study medication.|||Percentage of participants||80% Confidence Interval|Number
2664040|NCT01546038|Secondary|Overall Survival (OS) at Phase 2 Fit|OS was defined as duration from the date of randomization to the date of death from any cause. Kaplan-Meier (KM) method was used to estimate median OS. In this method, every participant had a follow-up time which was associated with an indicator, 1=event (death in our case), and 0 =censored. If the participants were not known to have died, time to date of last known to be alive was used as to calculate the follow-up time and indicator was 0 for these participants. KM method estimates the median OS based on the K-M curve. The K-M curve only drops when we had an event and censor data are the ticks in the graph. To estimate median OS, the K-M curve usually will be smoothed first and a line will be drawn at 50%. The median OS is the point when K-M curve and the horizontal hit. Survival status was collected every month for the first 2 months after discontinuation of study treatment and thereafter every 2 months until death or 4 years from each participant's first dose.|First dose to Follow-up (4 years)|Full analysis set: all enrolled participants of Phase 2 Fit arm who received at least 1 dose of study medication. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Months||80% Confidence Interval|Median
2664041|NCT01546038|Secondary|Overall Survival (OS) at Phase 1B|OS was defined as duration from the date of randomization to the date of death from any cause. Kaplan-Meier (KM) method was used to estimate median OS. In this method, every participant had a follow-up time which was associated with an indicator, 1=event (death in our case), and 0 =censored. If the participants were not known to have died, time to date of last known to be alive was used as to calculate the follow-up time and indicator was 0 for these participants. KM method estimates the median OS based on the K-M curve. The K-M curve only drops when we had an event and censor data are the ticks in the graph. To estimate median OS, the K-M curve usually will be smoothed first and a line will be drawn at 50%. The median OS is the point when K-M curve and the horizontal hit. Survival status was collected every month for the first 2 months after discontinuation of study treatment and thereafter every 2 months until death or 4 years from each participant's first dose.|First dose to Follow-up (4 years)|Full analysis set: all enrolled participants of Phase 1B portion who received at least 1 dose of study medication.|||Months||80% Confidence Interval|Median
2664056|NCT01545817|Secondary|Objective Response Rate (ORR) for the Pazopanib Treatment Period Using RECIST|"Percentage of patients with Complete or Partial Response at any time following the start of first-line pazopanib treatment.~RECIST Complete Response is defined to be a disappearance of all target lesion(s). RECIST Partial Response is defined to be at least a 30% decrease in the sum of the target lesion LDs."|Throughout the study period, up to 4 years|Intent to treat (ITT) population included all patients who received at least one dose of pazopanib and at least one dose of everolimus.|||Percentages of participants||95% Confidence Interval|Number
2664117|NCT01545232|Primary|24-hour Mortality||First 24 hours after ED admission|Number of subjects who were randomized to each group|||participants|||Number
2664042|NCT01546038|Primary|Overall Survival (OS) at Phase 2 Unfit|OS was defined as duration from the date of randomization to the date of death from any cause. Kaplan-Meier (KM) method was used to estimate median OS. In this method, every participant had a follow-up time which was associated with an indicator, 1=event (death in our case), and 0 =censored. If the participants were not known to have died, time to date of last known to be alive was used as to calculate the follow-up time and indicator was 0 for these participants. KM method estimates the median OS based on the K-M curve. The K-M curve only drops when we had an event and censor data are the ticks in the graph. To estimate median OS, the K-M curve usually will be smoothed first and a line will be drawn at 50%. The median OS is the point when K-M curve and the horizontal hit. Survival status was collected every month for the first 2 months after discontinuation of study treatment and thereafter every 2 months until death or 4 years from time of randomization for each participant.|Randomization to Follow-up (4 years)|Full analysis set: all randomized participants of Phase 2 Unfit arm.|||Months||80% Confidence Interval|Median
2664043|NCT01546038|Primary|Percentage of Participants With Complete Response (CR) at Phase 2 Fit|For AML participants:CR were those with repeat bone marrow showing <5% myeloblasts,spicules present and no Auer rods, peripheral blood showing neutrophils>=1000/mcL and platelets>=100,000/mcL, transfusion independent and no extramedullary disease. For MDS participants:CR were those with repeat bone marrow showing <=5% myeloblasts, peripheral blood showing neutrophils>=1000/mcL, platelets>=100,000/mcL, 0% blast and hemoglobin (Hgb)>= 11 g/dL, normal maturation of all cell lines.|4 years|Full analysis set: all enrolled participants of Phase 2 Fit arm who received at least 1 dose of study medication. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.|||Percentage of participants||80% Confidence Interval|Number
2664044|NCT01546038|Primary|Number of Participants With Dose-limiting Toxicities (DLTs) at Phase 1B|A DLT was any of the following adverse events (AEs) in Cycle 1 and considered by the investigator possibly related to glasdegib in combination with chemotherapy: (1) Grade >= 3 non-hematologic toxicity, excluding Grade >= 3 infection, fever (including febrile neutropenia), infusion related AEs, electrolyte abnormalities and ALT/AST elevation that returned to Grade <= 1 or baseline within 7 days; (2) prolonged myelosuppression that lasted longer than 42 days from the point of detection, defined as absolute neutrophil count (ANC) < 500/microliter(mcL) or platelet count < 10 *10^9/L with a normal bone marrow (<5% blasts and no evidence of disease or dysplasia); (3) inability to deliver at least 80% of the planned study doses for all agents in a combination due to non-hematologic toxicities; (4) Delay of >28 days in receiving the next scheduled cycle due to persisting non-hematologic toxicities. Arm A: Glasdegib+LDAC; Arm B: Glasdegib+Decitabine; Arm C: Glasdegib+Cytarabine/Daunorubicin.|Arms A and B: Cycle 1, Day 1 to Day 28; Arm C: Cycle 1, Day -3 to Day 21 or to Day 28 depending on when the next chemotherapy cycle was started|Per protocol analysis set: all enrolled participants in the dose escalation component who received at least 1 dose of glasdegib and of the co-administered chemotherapeutics and who did not have major treatment deviations during the DLT monitoring period.|||Participants|||Number
2664045|NCT01545843|Secondary|Neurological Function (Emotional Perception)|Emotional Perception is measured based on the percent of faces whose emotions are correctly identified using the Facial Emotion Perception Test (FEPT)|0 weeks, 2 weeks, 8 weeks|At some time points, some participants did not show up to appointments or allow a particular test to be employed.|||percentage of emotions accurately ID'ed||Standard Deviation|Mean
2664046|NCT01545843|Secondary|Change in Neurologic Functioning: Reaction Time|Reaction Time is measured using a modified Go/No-go test of inhibitory control|0, 2, 8 weeks|At some time points, some participants did not show up to appointments or allow a particular test to be employed.|||milliseconds||Standard Deviation|Mean
2664047|NCT01545843|Secondary|Change in Neuropsychological Functioning: Memory|Change in different aspects of thinking (e.g., memory, attention, executive functioning)|Baseline, 2 weeks, 8 weeks|At some time points, some participants did not show up to appointments or allow a particular test to be employed.|||words||Standard Deviation|Mean
2664048|NCT01545843|Secondary|Change in EEG Sleep Measures II (Sleep Efficiency)|Measurement of EEG activity during sleep using polysomnography: Sleep efficiency [(total sleep time/time in bed)*100]|Baseline, 2 weeks, 8 weeks|Subsequent rows have lower numbers of participants analyzed due to participant flow and/or unusable data.|||percent of sleep time||Standard Deviation|Mean
2664049|NCT01545843|Secondary|Change in EEG Sleep Measures I: Total Sleep Time|Measurement of EEG activity during sleep using polysomnography: Total Sleep Time is the length of time from sleep onset to final wake up minus any wakefulness during the night. It reflects the total amount of time asleep during the night.|Baseline, 2 weeks, 8 weeks|Number of participants analyzed decreases in subsequent rows, as some participants dropped out or had unusable data.|||minutes||Standard Deviation|Mean
2664050|NCT01545843|Secondary|Pittsburgh Sleep Quality Index|Self-report measure of sleep quality. The Pittsburgh Sleep Quality Index is a validated scale which measures self-reported sleep quality based on a wide variety of questions (duration, quality, disturbances, medication, etc.) and converts them to a scale which ranges from 0 to 21 where 6 or higher denotes poor sleep quality.|Baseline, 2 weeks and 8 weeks post-treatment|At some time points, some participants did not show up to appointments or allow a particular test to be employed.|||units on a scale||Standard Deviation|Mean
2664051|NCT01545843|Secondary|Quick Inventory of Depressive Symptoms (QIDS)|Patient-reported depression symptom severity at post-treatment, total score. Total scores range from 0 to 27. Higher scores represent more severe depression.|Post-treatment (8 weeks)||||units on a scale||Standard Deviation|Mean
2664052|NCT01545843|Primary|Hamilton Rating Scale for Depression-17 Item Minus Sleep Items|Total score on a clinician-rated measure of depressive symptoms, minus 3 sleep items Total score range: 0-46. Higher scores represent more severe depression.|Post-treatment (8 weeks)||||units on a scale||Standard Deviation|Mean
2664053|NCT01545817|Secondary|PFS for the Pazopanib Treatment Period Using RECIST|Time from first pazopanib dose until disease progression or death from any cause (whichever occurred earlier), provided this occurred prior to the start of everolimus and within 6 months of last dose of pazopanib|Throughout the study period, up to 4 years|ATS|||Months||95% Confidence Interval|Number
2664054|NCT01545817|Secondary|Overall Survival From the Start (OSS) of Study Treatment|Time from first pazopanib dose until death due to any cause in patients who received at least one dose of pazopanib followed by everolimus|Throughout the study, up to 4 years|ATS|||Months||95% Confidence Interval|Median
2664057|NCT01545817|Secondary|Objective Response Rate (ORR) for the Everolimus Treatment Period Using RECIST|"Percentage of patients with Complete or Partial Response at any time following the start of second-line everolimus treatment as per RECIST.~RECIST Complete Response is defined to be a disappearance of all target lesion(s). RECIST Partial Response is defined to be at least a 30% decrease in the sum of the target lesion LDs."|Throughout the study, up to 4 years|Intent to treat (ITT) population included all patients who received at least one dose of pazopanib and at least one dose of everolimus.|||Percentages of Participants||95% Confidence Interval|Number
2664058|NCT01545817|Secondary|Progression Free Survival (PFS) Rates|PFS rates 3 and 6 months after date of first dose of second-line everolimus treatment.|3 months, 6 months|Intent to treat (ITT) population included all patients who received at least one dose of pazopanib and at least one dose of everolimus.|||Survival probability||95% Confidence Interval|Number
2664059|NCT01545817|Primary|Progression Free Survival (PFS) for the Everolimus Treatment Period Using RECIST|"Time between the date of first everolimus dose and date of disease progression or death (whichever comes first) in patients treated initially with pazopanib.~Disease progression is measured by RECIST (Response Evaluation Criteria in Solid Tumors), which is at least a 20% increase in the sum of the target lesion longest diameters (LDs)."|Throughout the study period, up to 4 years|Intent to treat (ITT) population included all patients who received at least one dose of pazopanib and at least one dose of everolimus.|||months||95% Confidence Interval|Median
2664060|NCT01545765|Primary|Duration of Anesthesia(Minutes)|Onset and end of anesthesia are evaluated by Pinprick tests. Duration of anesthesia is calculated as: difference between onset and end of anesthesia (minutes).|From T0 (product removal) up to T8 hours after product removal|A standard sample size for this type of study is 30 subjects. The analyses are performed on the safety population (APT), corresponding to the enrolled and randomized population, after exclusion of subjects who never applied the treatments with certainty. Missing data were to be treated as missing for all analyses.|||Minutes||Full Range|Median
2664061|NCT01545765|Secondary|Adverse Events|Incidence of adverse events was to be reported during the study period|During the study|A standard sample size for this type of study is 30 subjects. The analyses are performed on the safety population (APT), corresponding to the enrolled and randomized population, after exclusion of subjects who never applied the treatments with certainty. Missing data were to be treated as missing for all analyses.|||participants|||Number
2664062|NCT01545700|Primary|Serum Blood Glucose Concentrations|Serum blood glucose concentrations|Patient were followed for the duration of hospitalization, for an average of 6 days|per protocol|||mg/dl||Standard Deviation|Mean
2664063|NCT01545700|Secondary|Pain Scores|VAS pain scoes at rest 0=no pain, 100=worst pain imaginable|Patients were followed for the duration of hospitalization, for an average of 6 days||||0-100 VAS scale scores on a scale||Standard Deviation|Mean
2664064|NCT01545648|Secondary|Correlation of Local Recurrence With DTC|Correlate breast cancer recurrence risk with individual values for DTC at each time point|Up to 12 months|Low accrual resulted in insufficient data to power statistical analyses for this outcome||||||
2664065|NCT01545648|Primary|Disseminated Tumor Cell Counts|Changes from baseline in disseminated tumor cell counts|Up to 12 months|Low accrual resulted in insufficient data to power statistical analyses for this outcome||||||
2664066|NCT01545648|Primary|Percentage of Change in Reduction of Disseminated Tumor Cells (DTC)/Mililitre (ml)|Reduction of disseminated tumor cells (DTC)/ mililitre (ml) from >10DTC/ml to ≤ 10DTC/ml. DTC measured by IE/FC in patients with early stage|Up to 12 months|Low accrual resulted in insufficient data to power statistical analyses for this outcome||||||
2664067|NCT01545583|Secondary|Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) of LY3016859 From Time Zero to Infinity (AUC0-inf)||Predose up to 8 weeks post dose|All randomized participants who received at least one dose of study drug and had sufficient LY3016859 pharmacokinetic data to calculate AUC0-inf.|||hour*nanograms/milliliter (h*ng/mL)||Standard Deviation|Mean
2664068|NCT01545583|Secondary|Pharmacokinetics: Maximum Serum Concentration (Cmax) of LY3016859||Predose up to 8 weeks post dose|All randomized participants who received at least one dose of study drug and had sufficient LY3016859 pharmacokinetic data to estimate Cmax.|||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
2664069|NCT01545583|Secondary|Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Epiregulin||Predose up to 8 weeks post dose|All randomized participants who received at least one dose of study drug and had serum epiregulin measurements.|||hour*picograms/milliliter (h*pg/mL)||Standard Deviation|Mean
2664070|NCT01545583|Secondary|Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Transforming Growth Factor Alpha (TGFα)||Predose up to 8 weeks post dose|All randomized participants who received at least one dose of study drug and had TGFα measurements.|||hour*nanograms/milliliter (h*ng/mL)||Standard Deviation|Mean
2664071|NCT01545583|Primary|Number of Participants With One or More Drug-Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAE)|Drug-related TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. A summary of SAEs and other nonserious AEs, regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.|From baseline up to 8 weeks post dose|All randomized participants who received at least one dose of study drug.|||participants|||Number
2664072|NCT01545518|Primary|Immune Abnormalities|neuronal nuclear, cytoplasmic, and cell surface autoantibodies|Screening visit|No analysis occurred and study was terminated early due to subject numbers not eligible for the 2nd phase of the study.||||||
2664073|NCT01545388|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event||Up to 24 weeks|All participants as treated defined as all randomized participants who received at least one dose of study treatment.|||Participants|||Number
2664074|NCT01545388|Primary|Percentage of Participants Who Experienced at Least One Adverse Event||Up to 26 weeks|All participants as treated defined as all randomized participants who received at least one dose of study treatment.|||Percentage of participants|||Number
2664114|NCT01545232|Secondary|Hospital Free Days||first 30 days after ED admission|Number of hospital free days for each group.|||days||Inter-Quartile Range|Median
2664118|NCT01545193|Secondary|PACU Length of Stay|The time required to meet discharge criteria and achieve actual discharge will be noted.|Early postoperative period, up to 24 hours||||minutes||Inter-Quartile Range|Median
2664075|NCT01545388|Secondary|Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)|Based on a cLDA model with terms for treatment, other prior AHA therapy status other than sitagliptin (yes/no), study drug regimen (just before meal/after meal), sitagliptin dosage (50 mg/100 mg), time and the interaction of time by treatment, time by other prior AHA therapy status, time by study drug regimen, time by sitagliptin dosage and study drug regimen by sitagliptin dosage, with a constraint that the mean baseline is the same for all treatment groups.|Baseline and Week 24|Per-protocol population defined as all randomized participants who had at least one measurement (baseline or post-randomization), with participants and/or selected data excluded due to protocol violations.|||mg/dL||95% Confidence Interval|Least Squares Mean
2664076|NCT01545388|Primary|Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)|Based on a constrained longitudinal data analysis (cLDA) model with terms for treatment, other prior antihyperglycemic agent (AHA) therapy status other than sitagliptin (yes/no), study drug regimen (just before meal/after meal), sitagliptin dosage (50 mg/100 mg), time and the interaction of time by treatment, time by other prior AHA therapy status, time by study drug regimen, time by sitagliptin dosage and study drug regimen by sitagliptin dosage, with a constraint that the mean baseline is the same for all treatment groups.|Baseline and Week 24|Per-protocol population defined as all randomized participants who had at least one measurement (baseline or post-randomization), with participants and/or selected data excluded due to protocol violations.|||Percent of glycosylated hemoglobin||95% Confidence Interval|Least Squares Mean
2664077|NCT01545375|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.|From Day 0 to Month 22|Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose.|||Participants|||Count of Participants
2664078|NCT01545375|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) After Booster Vaccination - Immuno/Reacto Sub-cohort|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.|Within the 31-day (Days 0-30) period post booster vaccination|Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom the booster vaccination dose was documented.|||Participants|||Count of Participants
2664079|NCT01545375|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs) After Primary Vaccination - Immuno/Reacto Sub-cohort|An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. The Immuno/reacto sub-cohort was composed of 200 vaccinated subjects from each study group.|Within the 31-day (Days 0-30) period post primary vaccination, across doses|Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom at least one vaccination dose was documented.|||Participants|||Count of Participants
2664080|NCT01545375|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Booster Vaccination - Immuno/Reacto Sub-cohort|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (axillary route - temperature equal or higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (>) 40.0°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.|Within the 4-day (Days 0-3) post-booster vaccination period|Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom the booster vaccination dose was documented.|||Participants|||Count of Participants
2664081|NCT01545375|Secondary|Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort|Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (axillary route - temperature equal or higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (>) 40.0°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.|Within the 4-day (Days 0-3) post-primary vaccination period following each dose|Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom at least one vaccination dose was documented.|||Participants|||Count of Participants
2668592|NCT01504971|Secondary|Association of Each Endoscopic Finding With Symptom Score|Symptom score is assessed by a self-reported questionnaire|1 month|||||||
2664082|NCT01545375|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Booster Vaccination - Immuno/Reacto Sub-cohort|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.|Within the 4-day (Days 0-3) post-booster vaccination period|Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom the booster vaccination dose was documented.|||Participants|||Count of Participants
2664083|NCT01545375|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort|Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.|Within the 4-day (Days 0-3) post-primary vaccination period following each dose|Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom at least one vaccination dose was documented.|||Participants|||Count of Participants
2664084|NCT01545375|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine-related pneumococcal serotypes 6C (OPA-6C). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 145.|One month post-dose 3 [PIII(Month 5)] and one month post-booster dose [Post-booster(Month 11)]|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2664085|NCT01545375|Secondary|Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes|Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) LLOQ: 8 for OPA-1, OPA-3 and OPA-6B; 33 for OPA-4, and OPA-14; 50 for OPA-5; 151 for OPA-6A; 330 for OPA-7F; 275 for OPA-9V; 11 for OPA-18C; 143 for OPA-19A; 36 for OPA-19F; 101 for OPA-23F.|One month post-dose 3 [PIII(Month 5)] and one month post-booster dose [Post-booster(Month 11)]|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2664086|NCT01545375|Secondary|Antibody Concentrations Against Vaccine-related Serotypes 6C|No analysis was performed on antibody concentrations against vaccine-related serotype 6C as no specific qualified/validated assay was available.|One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one month post-booster dose [Post-booster(Month 11)]|The analysis was to be performed on the ATP cohort for immunogenicity. But no analysis was performed for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.||||||
2664087|NCT01545375|Secondary|Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F|Antibody concentrations were measured by Electro-chemiluminescence assay (ECL), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was a serotype-specific antibody concentration higher than or equal to (≥) LLOQ (Lower Limit of Quantification) expressed in µg/mL: 0.08 for Anti-1; 0.075 for anti-3; 0.061 for Anti-4; 0.198 for Anti-5; 0.111 for Anti-6A and Anti-18C; 0.102 for Anti-6B; 0.063 for Anti-7F; 0.066 for Anti-9V; 0.160 for Anti-14; 0.199 for Anti-19A; 0.163 for Anti-19F; 0.073 for Anti-23F.|One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one month post-booster dose [Post-booster(Month 11)]|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2664088|NCT01545375|Secondary|Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Immuno/Reacto Sub-cohort|Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL.|1 month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)], 1 month post-booster dose [Post-booster(Month 11)], 12 months post-booster dose [Post-booster(Month 22)]|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2664089|NCT01545375|Secondary|Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies|Inhibition of Ply hemolysis activity was not evaluated due to assay stability issues.|One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one and twelve months post-booster dose [Post-booster(Month 11) and Post-booster(Month 22)], respectively|The analysis was to be performed on the according to protocol cohort for immunogenicity. But inhibition of Ply hemolysis activity was not evaluated due to assay stability issues.||||||
2664090|NCT01545375|Secondary|Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Immuno/Reacto Sub-cohort|Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations equal to (=) 12 EL.U/mL for anti-Ply antibodies and = 17 EL.U/mL for anti-PhtD antibodies.|One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one and twelve months post-booster dose [Post-booster(Month 11) and Post-booster(Month 22)], respectively|Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2664091|NCT01545375|Secondary|Number of Subjects With S. Pneumoniae (Any and Serotype Specific) in the Nasopharynx - Carriage Sub-cohort|Positive cultures of S. pneumoniae (any and serotype specific) identified in the nasopharynx were analyzed.|At 7 months of age (Month 5), 12-15 months of age (Month 10),18-22 months of age (Month 16) and 24-27 months of age (Month 22)|Analysis was performed on the Total vaccinated cohort for carriage which included around 400 subjects not included in the immuno/reacto sub-cohort, who had received at least one vaccination dose and for whom data concerning carriage outcome measures were available.|||Participants|||Count of Participants
2664092|NCT01545375|Secondary|Time to Occurrence of Any Medically Attended Healthcare-provider-diagnosed ALRI With Fever Documented at the Visit or History of Fever Within 3 Days Preceding a Given Episode.|Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/ sum of follow-up expressed in years (T[year)]). A healthcare-provider-diagnosed ALRI with fever case was defined as, but not limited to, chest infection, bronchiolitis, pneumonia, bronchopneumonia, pleural effusion or empyema diagnosed by a treating physician or equivalent licensed medical professional with fever documented at the time of visit or history of fever within 3 days preceding a given episode and with or without other clinical symptoms documented in the routine medical record.|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.|||Episodes per person-year|||Number
2664093|NCT01545375|Secondary|Time to Occurrence of Medically Attended ALRI With Fever Documented at the Visit or History of Fever Within 3 Days Preceding a Given Episode|Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/ sum of follow-up expressed in years (T[year)]). ALRI was defined by the presence of tachypnea (respiratory rate >50 amongst children 2 to 12 months of age, and respiratory rate >40 in children over 1 year of age) and at least two of the following signs and symptoms: cough; fever documented at visit or reported within preceding 3 days (Fever is defined as temperature ≥100.4°F (38.0°C) regardless of the route of measurement); increased work of breathing: grunting, nasal flaring, and intercostal and/or subcostal retractions; auscultatory abnormalities: wheezing, crackles, rhonchi, decreased breath sounds.|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.|||Episodes per person-year|||Number
2664094|NCT01545375|Secondary|Time to Occurrence of Medically Attended Acute Lower Respiratory Tract Infection (ALRI)|Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/ sum of follow-up expressed in years (T[year)]). ALRI was defined by the presence of tachypnea (respiratory rate >50 amongst children 2 to 12 months of age, and respiratory rate >40 in children over 1 year of age) and at least two of the following signs and symptoms: cough; fever documented at visit or reported within preceding 3 days (Fever was defined as temperature ≥100.4°F (38.0°C) regardless of the route of measurement); increased work of breathing: grunting, nasal flaring, and intercostal and/or subcostal retractions; auscultatory abnormalities: wheezing, crackles, rhonchi, decreased breath sounds.|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.|||Episodes per person-year|||Number
2664095|NCT01545375|Secondary|Number of Subjects With Any Acute Otitis Media (AOM) With Temporally Related Carriage|AOM with temporally related carriage was defined as AOM with nasopharyngeal swab taken within 3 days before or after an AOM episode.|From the administration of dose 1 up to Month 22|Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose.|||Participants|||Count of Participants
2664096|NCT01545375|Secondary|Time to Occurrence of Any Draining Pneumococcal Acute Otitis Media (AOM)|Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]). Draining AOM was defined as AOM with otorrhea or with spontaneously perforated tympanic membrane. In this case, middle ear fluid (MEF) was to be swabbed with no tympanocentesis needed and tested for the presence of S. pneumoniae and other pathogens as part of the routine clinical practice. Draining pneumococcal AOM were defined as draining AOM cases with S. pneumoniae identified in MEF.|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.|||Episodes per person-year|||Number
2664097|NCT01545375|Secondary|Time to Occurrence of Any Draining Acute Otitis Media (AOM)|Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]). Draining AOM was defined as AOM with otorrhea or with spontaneously perforated tympanic membrane. In this case, middle ear fluid (MEF) was to be swabbed with no tympanocentesis needed and tested for the presence of S. pneumoniae and other pathogens as part of the routine clinical practice. Draining pneumococcal AOM were defined as draining AOM cases with S. pneumoniae identified in MEF.|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.|||Episodes per person-year|||Number
2664098|NCT01545375|Secondary|Number of Subjects With Any Recurrent Healthcare Provider Diagnosed Acute Otitis Media (AOM)|Recurrent AOM was defined as at least 3 AOM episodes diagnosed by a physician or equivalent licensed medical professional and occurring within 6 months or at least 4 episodes within one year, regardless of the etiology.|From the administration of dose 1 up to Month 22|Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose.|||Participants|||Count of Participants
2664099|NCT01545375|Secondary|Time to Occurrence of Any Clinical Acute Otitis Media (AOM) Diagnosed and Verified Against Modified American Academic of Pediatrics (AAP) Criteria|Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]). Definition of clinical AOM diagnosed and verified against modified AAP criteria required a history of acute disease (i.e. AAP criterion 1) together with abnormal tympanic membrane (i.e. one of the AAP criteria 2 or 3a), as per the judgment of a treating physician or equivalent licensed medical professional: 1. A history of acute (recent, usually abrupt) onset of signs and symptoms of middle-ear inflammation and middle-ear effusion (MEE).AND 2. The presence of MEE that is indicated by any of the following: a) Bulging of tympanic membrane, b) Limited or absent mobility of tympanic membrane, c) Air-fluid level behind tympanic membrane, d) Otorrhea OR 3. Signs or symptoms of middle-ear inflammation as indicated by: a) Distinct erythema of tympanic membrane.|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.|||Episodes per person-year|||Number
2664100|NCT01545375|Secondary|Time to Occurrence of Any Episodes of AOM Diagnosed by Healthcare-provider|Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]). A healthcare-provider-diagnosed clinical AOM case was defined as an AOM event diagnosed by a treating physician or equivalent licensed medical professional with or without clinical symptoms documented in the routine medical record.|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.|||Episodes per person-year|||Number
2664101|NCT01545375|Primary|Time to Occurrence of Any Acute Otitis Media (AOM) Diagnosed and Verified Against American Academic of Pediatrics (AAP) Criteria|Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]). Definition of clinical AOM diagnosed and verified against AAP criteria required meeting three criteria based on the guidelines from the AAP [AAP, 2004], as per the judgment of a treating physician or equivalent licensed medical professional: A history of acute (recent, usually abrupt) onset of signs and symptoms of middle-ear inflammation and middle-ear effusion (MEE).AND The presence of MEE indicated by any of the following: a) Bulging of tympanic membrane; b) Limited or absent mobility of tympanic membrane; c) Air-fluid level behind tympanic membrane; d) Otorrhea AND Signs or symptoms of middle-ear inflammation as indicated by either: a) Distinct erythema of tympanic membrane or b) Distinct otalgia (discomfort clearly referable to the ear[s] that resulted in interference with or precluded normal activity or sleep).|Any time from 2 weeks after the administration of dose 3 up to Month 22|Analysis was performed on the modified according to protocol cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort.|||Episodes per person-year|||Number
2664102|NCT01545336|Secondary|Six Minute Walk Distance||Baseline, 3 months||||% change from baseline||Inter-Quartile Range|Median
2664103|NCT01545336|Primary|Tricuspid Annular Plane Systolic Excursion (TAPSE)||Baseline, 3 months||||% change from baseline||Inter-Quartile Range|Median
2664104|NCT01545336|Primary|Plasma Estradiol (E2) Level||Baseline, 3 months||||% change from baseline||Inter-Quartile Range|Median
2664105|NCT01545232|Secondary|Amount of Blood Products Given From Hemostasis to 24 Hours After ED Admission||24 hours after ED admission|Unit of measure for outcome measures below is median number of blood product units that given in each group (1:1:1 or 1:1:2) from time initial hemostasis was complete (PROPPR randomized study products stopped) up to 24 hours following ED admission. Number of participants is based on those who survived up to 24 hours, not participants randomized.|||units of blood products||Inter-Quartile Range|Median
2664106|NCT01545232|Secondary|ICU Free Days||first 30 days after ED admission|Number of ICU free days for each group.|||days||Inter-Quartile Range|Median
2664107|NCT01545232|Secondary|Ventilator Free Days||first 30 days after ED admission|Number of ventilator free days for each group.|||days||Inter-Quartile Range|Median
2664108|NCT01545232|Secondary|Initial Hospital Discharge Status||Hospital discharge or 30 days, whichever comes first|Disposition of subject at time of hospital discharge|||participants|||Number
2664109|NCT01545232|Secondary|Incidence of Transfusion Related Serious Adverse Events||ED admission to hospital discharge or 30 days, whichever comes first|Incidence of transfusion related serious adverse events-Reportable to FDA|||participants|||Number
2664110|NCT01545232|Secondary|Incidence of Primary Surgical Procedure||ED admission to hospital discharge or 30 days, whichever comes first|Incidence of primary surgical procedure|||participants|||Number
2664111|NCT01545232|Secondary|Functional Status at Time of Hospital Discharge|The Glasgow Outcome Extended Score (GOSE) is a tool used to measure recovery following brain injury and assists with prediction of long-term rehabilitation. The 8 scoring categories are death, vegetative state, lower severe disability, upper severe disability, lower moderate disability, upper moderate disability, lower good recovery and upper good recovery. A higher GOSE score correlates with better outcome.|Hospital discharge or 30 days, whichever comes first|Glasgow Outcome Extended Score (GOSE) Score on discharged patients who had a head injury (Abbreviated Injury Score (AIS) > 1) ranging from 1 to 8. The AIS is a coding scale to classify the injury severity. A score is created for each body region, type of anatomic structure (i.e. whole area, vessels,organs), and severity(minor to maximum).|||units on the GOSE scale||Inter-Quartile Range|Median
2664112|NCT01545232|Secondary|Amount of Randomized Blood Products Given to Hemostasis||24 hours from randomization||||units of blood products||Inter-Quartile Range|Median
2664113|NCT01545232|Secondary|Time to Hemostasis|Time to hemostasis refers to the time that the subject achieved hemorrhage control (anatomic hemostasis and resuscitation complete)following emergency department (ED) arrival.|ED admission to hospital discharge or 30 days, whichever comes first|Time to anatomic hemostasis|||minutes||Inter-Quartile Range|Median
2664119|NCT01545193|Secondary|Respiratory Events Potentially Related to Residual Neuromuscular Blockade|Pulse oximetry will be used to continuously monitor arterial oxygen saturations (Sp02) during patient transport and in the PACU. Data reported are the number of patients developing hypoxemia (oxygen saturation < 94% on pulse oximetry) in the PACU|Early postoperative period, up to 24 hours||||participants|||Number
2664120|NCT01545193|Secondary|Signs and Symptoms of Residual Neuromuscular Blockade|A standardized examination form will be used to determine the presence or absence of muscle weakness in a variety of muscle groups. The examination will be performed on arrival to the PACU and again 15 minutes after admission. Reported data is the total number of symptoms (0-16) at PACU admission|Early postoperative period, up to 24 hours||||symptoms||Inter-Quartile Range|Median
2664121|NCT01545193|Primary|Incidence of Residual Neuromuscular Blockade|The TOF-Watch SX will be used to determine the incidence of residual neuromuscular blockade. The TOF-Watch SX consists of a nerve stimulator and a sensor to quantify the TOF ratio. Two consecutive responses to train-of-four (TOF) stimulation will be obtained, and the average of the two values recorded. If the measurements differ by greater than 10%, additional TOF ratios can be obtained (up to a total of 4 TOF values), and the closest two ratios averaged. The number of patients with TOF ratios < 0.9 in each group will be compared.|Early postoperative period, up to 24 hours||||participants|||Number
2664122|NCT01545076|Secondary|Change in INCAT During IgPro10 Rescue Therapy|"The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 (No upper limb problems) to 5 (Inability to use either arm for any purposeful movement), and scores for leg disability range from 0 (Walking not affected) to 5 (Restricted to wheelchair, unable to stand and walk a few steps with help). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the adjusted INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant."|Before first rescue IgPro10 infusion and up to 13 weeks|RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure.|||units on a scale||Standard Deviation|Mean
2664123|NCT01545076|Secondary|Change in R-ODS During IgPro10 Rescue Therapy|The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).|Before first rescue IgPro10 infusion and up to 13 weeks|RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure.|||units on a scale||Standard Deviation|Mean
2664124|NCT01545076|Secondary|Change in MRC Sum Score During IgPro10 Rescue Therapy|An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength).|Before first rescue IgPro10 infusion and up to 13 weeks|RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure.|||units on a scale||Standard Deviation|Mean
2664125|NCT01545076|Secondary|Change in Mean Grip Strength During IgPro10 Rescue Therapy|The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength median score of the dominant hand was determined.|Before first rescue IgPro10 infusion and up to 13 weeks|RSDS. Not all subjects from the RSDS were available for data collection for this outcome measure.|||kPa||Standard Deviation|Mean
2664126|NCT01545076|Secondary|Percent of Subjects With Adverse Events During IgPro10 Rescue Therapy||Up to 13 weeks|RSDS|||percentage of subjects|||Number
2664127|NCT01545076|Secondary|Number of Subjects With Adverse Events During IgPro10 Rescue Therapy||Up to 13 weeks|RSDS|||participants|||Number
2664128|NCT01545076|Secondary|Number of Adverse Events Per IgPro10 Infusion During Rescue Therapy||Up to 13 weeks|RSDS|||Adverse events/Infusion|||Number
2664129|NCT01545076|Secondary|Time to Improvement After CIDP Relapse During IgPro10 Rescue Therapy|"Improvement is defined as a decrease in INCAT score (except for the decrease from 1 to 0 in the upper limb score) back to or below the baseline score..The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 (No upper limb problems) to 5 (Inability to use either arm for any purposeful movement), and scores for leg disability range from 0 (Walking not affected) to 5 (Restricted to wheelchair, unable to stand and walk a few steps with help). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the adjusted INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant."|Up to 13 weeks|Rescue Medication Safety Data Set (RSDS): The RSDS consists of subjects of the SDS who received at least 1 dose of IgPro10 rescue medication.|||Days||95% Confidence Interval|Median
2664130|NCT01545076|Secondary|Percent of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy||Up to 13 weeks|PSDS|||percentage of subjects|||Number
2664131|NCT01545076|Secondary|Number of Subjects With Adverse Events During IgPro10 Re-stabilization Therapy||Up to 13 weeks|PSDS|||participants|||Number
2664132|NCT01545076|Secondary|Number of Adverse Events Per IgPro10 Infusion During Re-stabilization Therapy||Up to 13 weeks|PSDS|||Adverse events/Infusion|||Number
2664133|NCT01545076|Secondary|Change in INCAT During IgPro10 Re-stabilization Therapy|"The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 (No upper limb problems) to 5 (Inability to use either arm for any purposeful movement), and scores for leg disability range from 0 (Walking not affected) to 5 (Restricted to wheelchair, unable to stand and walk a few steps with help). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the adjusted INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant."|Reference visit and up to 13 weeks|PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure.|||units on a scale||Standard Deviation|Mean
2664134|NCT01545076|Secondary|Change in R-ODS During IgPro10 Re-stabilization Therapy|The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).|Reference visit and up to 13 weeks|PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure.|||units on a scale||Standard Deviation|Mean
2664135|NCT01545076|Secondary|Change in MRC Sum Score During IgPro10 Re-stabilization Therapy|An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength).|Reference visit and up to 13 weeks|PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure.|||units on a scale||Standard Deviation|Mean
2664136|NCT01545076|Secondary|Change in Mean Grip Strength During IgPro10 Re-stabilization Therapy|The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength median score of the dominant hand was determined.|Reference visit and up to 13 weeks|PSDS. Not all subjects from the PSDS were available for data collection for this outcome measure.|||kPa||Standard Deviation|Mean
2664137|NCT01545076|Secondary|Time to Improvement During IgPro10 Re-stabilization Therapy|Improvement is defined as an INCAT score decrease by 1 point (except for the decrease from 1 to 0 in the upper limb score), R-ODS improvement by at least 4 points, Mean Grip strength improvement by at least 8 kPa in one hand, or MRC Sum score >=3.|Up to 13 weeks|Pre-randomization Safety Data Set (PSDS): The PSDS was based on all subjects enrolled into the study who received at least 1 dose of IgPro10 (in the re-stabilization period) before randomization into the subcutaneous period. One subject withdrew from the re-stabilization period prior to receiving IgPro10, therefore n=207 for the PSDS.|||Days||95% Confidence Interval|Median
2664138|NCT01545076|Secondary|Percentage of Subjects With Adverse Events During the SC Treatment Period||Up to 28 weeks|SDS|||percentage of subjects|||Number
2664139|NCT01545076|Secondary|Number of Subjects With Adverse Events During the SC Treatment Period||Up to 28 weeks|SDS|||Participants|||Count of Participants
2664140|NCT01545076|Secondary|Number of Adverse Events Per IgPro20 Infusion During the SC Treatment Period||Up to 28 weeks|Safety Data Set (SDS): The SDS consists of all randomized subjects who received at least 1 dose of IgPro20 or placebo.|||Adverse events/Infusion|||Number
2664141|NCT01545076|Secondary|Time to CIDP Relapse or Withdrawal Due to Any Other Reason During the SC Treatment Period||Up to 25 weeks|ITTS|||Days||95% Confidence Interval|Median
2664142|NCT01545076|Secondary|Change in Rasch-built Overall Disability Scale (R-ODS) Scores During the SC Treatment Period|The R-ODS centile score captures activity and social participation in subjects with CIDP. The R-ODS centile score ranges from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations).|Baseline and up to 25 weeks|ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure.|||units on a scale||Full Range|Median
2664143|NCT01545076|Secondary|Change in the Medical Research Council (MRC) Sum Scores During the SC Treatment Period|An adapted version of the MRC sum score was used in the study. The MRC sum score is the sum of all 16 muscle scores, and ranges from 0 (paralysis) to 80 (normal strength).|Baseline and up to 25 weeks|ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure.|||units on a scale||Full Range|Median
2664144|NCT01545076|Secondary|Median Change From Baseline in the Mean Grip Strength Scores of the Dominant Hand During the SC Treatment Period|The hand-held Vigorimeter is a device that measures the strength of small muscles in the hand; ie, grip strength. Subjects squeezed a rubber bulb lying between the palm of the hand and the thumb and index fingers. The pressure was recorded via a rubber tube on a nanometer and expressed in kilopascal. At each assessment, the subjects squeezed 3 times with each hand. The mean grip strength median score of the dominant hand was determined.|Baseline and up to 25 weeks|ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure..|||Kilopascal (kPa)||Full Range|Median
2664145|NCT01545076|Secondary|Change in Inflammatory Neuropathy Cause and Treatment (INCAT) Scores During the SC Treatment Period|"The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 (No upper limb problems) to 5 (Inability to use either arm for any purposeful movement), and scores for leg disability range from 0 (Walking not affected) to 5 (Restricted to wheelchair, unable to stand and walk a few steps with help). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the adjusted INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant."|Baseline and up to 25 weeks|ITTS. Not all subjects from the ITTS were available for data collection for this outcome measure.|||units on a scale||Full Range|Median
2664146|NCT01545076|Primary|Percentage (%) of Subjects With CIDP Relapse or Are Withdrawn for Any Other Reason During the Subcutaneous (SC) Treatment Period|"Relapse is defined as an increase of at least 1 INCAT score point (except for the increase from 0 to 1 in the upper limb score). The INCAT score is a 10-point scale that covers the functionality of legs and arms, and has been successfully used to measure treatment effects in various CIDP studies. Scores for arm disability range from 0 (No upper limb problems) to 5 (Inability to use either arm for any purposeful movement), and scores for leg disability range from 0 (Walking not affected) to 5 (Restricted to wheelchair, unable to stand and walk a few steps with help). The INCAT (total) score is the sum of these 2 scores and ranges from 0 to 10. For the adjusted INCAT score, changes in the function of the upper limbs from 0 (normal) to 1 (minor symptoms) or from 1 to 0 were not recorded as deterioration or improvement because these changes are not considered clinically significant."|Up to 25 weeks|Intention-to-treat Set (ITTS): The ITTS consists of all randomized subjects who received at least 1 dose of IgPro20 / placebo and satisfied inclusion criterion #1 (diagnosis of CIDP).|||percentage of subjects|||Number
2664147|NCT01544998|Secondary|Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes for Preclinical Diastolic Dysfunction (PDD) Reporting Group|Value at 60 minutes minus value at baseline.|Baseline, 60 minutes after saline load|This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.|||pmol/min||Standard Deviation|Mean
2664148|NCT01544998|Secondary|Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes for Preclinical Systolic Dysfunction (PSD) Reporting Group|Value at 60 minutes minus value at baseline.|Baseline, 60 minutes after saline load|This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.|||pmol/min||Standard Deviation|Mean
2664149|NCT01544998|Secondary|Change in Glomerular Filtration Rate (GFR) at 60 Minutes for Preclinical Diastolic Dysfunction (PDD) Reporting Group|Value at 60 minutes minus value at baseline.|Baseline, 60 minutes after saline load|This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.|||mL/min/1.73 m^2||Standard Deviation|Mean
2664150|NCT01544998|Secondary|Change in Glomerular Filtration Rate (GFR) at 60 Minutes for Preclinical Systolic Dysfunction (PSD) Reporting Group|Value at 60 minutes minus value at baseline.|Baseline, 60 minutes after saline load|This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.|||mL/min/1.73 m^2||Standard Deviation|Mean
2664151|NCT01544998|Primary|Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes for Preclinical Diastolic Dysfunction (PDD) Reporting Group|Value at 60 minutes minus value at baseline.|Baseline, 60 minutes after saline load|This was a within PDD reporting group comparison; between PSD and PDD groups were not compared.|||mEq/min||Standard Deviation|Mean
2664152|NCT01544998|Primary|Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes for Preclinical Systolic Dysfunction (PSD) Reporting Group|Value at 60 minutes minus value at baseline.|Baseline, 60 minutes after saline load|This was a within PSD reporting group comparison; between PSD and PDD groups were not compared.|||mEq/min||Standard Deviation|Mean
2664153|NCT01544920|Secondary|Percentage of Participants Who Had Undetectable HCV RNA at Week 4 Achieving SVR24|SVR24 rates were determined for only participants that had undetectable HCV RNA at Week 4 of treatment (Arm 1a and Arm 2a). HCV RNA viral load was determined using the Roche COBAS® AmpliPrep/COBAS® TaqMan HCV Test v1.0, which has a lower limit of quantification of 43 IU/mL.|Up to Week 48|The Full Analysis Set (FAS) consisted of all participants who completed the 4-week peg-IFN + RBV lead-in, who were randomized at Week 4, and also had undetectable HCV RNA at Week 4.|||Percentage of participants|||Number
2664154|NCT01544920|Primary|Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) 24 Weeks After Completing Study Treatment (SVR24)|SVR24 rates were determined for all participants in Arm 1 and Arm 2. HCV RNA viral load was determined using the Roche COBAS® AmpliPrep/COBAS® TaqMan HCV Test v1.0, which has a lower limit of quantification of 43 IU/mL.|Up to Week 74|The Full Analysis Set (FAS) consisted of all participants who completed the 4-week peg-IFN + RBV lead-in and who were randomized at Week 4.|||Percentage of participants|||Number
2664155|NCT01544595|Secondary|Electrocardiogram: Number of Participants With ECG Test Results - Entire Treatment Period|QTcB: QT interval corrected using Bazett's formula QTcF: QT interval corrected using Fridericia's formula A patient with multiple variable measurements is counted only once under the worst condition.|Approximately 4 years|Safety set|||Participants|||Number
2664156|NCT01544595|Secondary|Electrocardiogram: Incidence of Participants With ECG Test Results - Randomized Withdrawal Period|"QTcB: QT interval corrected using Bazett's formula QTcF: QT interval corrected using Fridericia's formula A patient with multiple variable measurements is counted only once under the worst condition.~IR=incidence rate per 100 subject years."|Week 52 - 156|Safety set|||IR||95% Confidence Interval|Number
2664157|NCT01544595|Secondary|Clinical Laboratory Evaluation: Number of Participants With Clinically CTCAE - Entire Study Period|CTCAE: common terminology criteria for adverse events. A subject with multiple variable measurements is counted only once under the worst condition. LLN = lower limit of normal.|approximately 4 years|Safety set: The safety set included all patients who took at least one dose of study treatment during the treatment period. Patients were be analyzed according to treatment received.|||Participants|||Number
2664158|NCT01544595|Secondary|Clinical Laboratory Evaluation - Hematology Parameters: Incidence Rate for Participants With Clinically CTCAE - Randomized Withdrawal Period|"CTCAE: common terminology criteria for adverse events. A subject with multiple variable measurements is counted only once under the worst condition. LLN = lower limit of normal.~IR=incidence rate per 100 subject years"|Week 52-156|Safety set|||IR||95% Confidence Interval|Number
2664159|NCT01544595|Secondary|EQ-5D Health State Assessment (Observed Value) - Entire Study Period|EQ-5D: EuroQOL 5-Dimension Health Status Questionnaire. The EQ-5D© is a generic instrument to assess each patient's health status. It provides a simple descriptive profile and a single index value for health status. The EQ visual analog scale records the respondent's self-rated health on a vertical scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.|week 64, 76, 88, 104, 116, 128, 140, and 156|FAS|||Percent change||Standard Deviation|Mean
2664160|NCT01544595|Secondary|EQ-5D Health State Assessment (Observed Value) - Randomized Withdrawal Period|EQ-5D: EuroQOL 5-Dimension Health Status Questionnaire. The EQ-5D© is a generic instrument to assess each patient's health status. It provides a simple descriptive profile and a single index value for health status. The EQ visual analog scale records the respondent's self-rated health on a vertical scale where the endpoints are labeled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.|Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156|FAS|||Percent change||Standard Deviation|Mean
2664161|NCT01544595|Secondary|Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Entire Treatment Period|Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment.|Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156|FAS|||Number of participants|||Number
2664162|NCT01544595|Secondary|Number of Participants With Dermatology Life Quality Index Response (DLQI 0 or 1) - Randomized Withdrawal Period (Observed Data)|Dermatology Life Quality Index (DLQI) scores range from 0 to 30. Lower absolute scores on DLQI indicate better/improved health-related quality-of life impairment.|Week 52 (baseline), 64, 76, 88, 104, 116, 128, 140, and 156|FAS|||Number of participants|||Number
2664316|NCT01544062|Secondary|24 Hour Postoperative Pain Scores at Rest|Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).|24 hours after arriving in ICU|Missing data for 3 study subjects in normal saline group.|||units on a scale||Standard Deviation|Mean
2664163|NCT01544595|Secondary|Percent of Participants With Rebound After Last Injection|Rebound: PASI increases to > 125% of baseline (where baseline is the PASI at the randomization of the core study) or presence of new pustular psoriasis, new erythrodermic psoriasis or more inflammatory psoriasis occurring within 8 Weeks of stopping therapy (after the last dose of study treatment received). Rebound like event (RLE) was defined as increase of PASI of > 125% from baseline value or occurrence of new pustular, new erythrodermic or more inflammatory psoriasis any time after stopping therapy (last treatment administered) up to Week 68. Rebound was evaluated for the patients randomized to the placebo groups in the extension study; hence these patients received the last dose of secukinumab during the core studies.|up to week 68|FAS|||Percent of participants with rebound||95% Confidence Interval|Number
2664164|NCT01544595|Secondary|Percent of Participants With Relapse After Last Injection|"Relapse: when the achieved maximal PASI improvement from baseline of core study was reduced by >50%.~Time 0 = week 52"|up to week 16|FAS|||Percent of participants with relapse||95% Confidence Interval|Number
2664165|NCT01544595|Secondary|Percent pf Participants With Relapse Over Time - Randomized Withdrawal Period|Time 0 = week 52|up to week 156|FAS|||Percent of participants with relapses||95% Confidence Interval|Number
2664166|NCT01544595|Secondary|Percent of Participants With IGA Mod 0 or 1 Response - Treatment Period for Re-treated After Relapse|"IGA mod 2011 0 or 1 response since reinitiating treatment after relapse for subjects with IGA 0 or 1 response at week 52 and not have IGA 0 or 1 response at relapse.~time = 0 refers to Week 52"|up to week 260|FAS|||Percent of participants||95% Confidence Interval|Number
2664167|NCT01544595|Secondary|Percent of Participants With PASI 75 Response - Treatment Period for Re-treated After Relapse|PASI 75 response since reinitiating treatment after relapse. time = 0 refers to Week 52|up to week 260|FAS|||Percent of participants||95% Confidence Interval|Number
2664168|NCT01544595|Secondary|Percent of Participants With Loss of IGA Mod 2011 0 or 1 Response Over Time for Subjects With IGA Mod 2011 0 or 1 Response at Week 52 - Randomized Withdrawal Period|"Summary for loss of IGA mod 2011 0 or 1 response over time for patients with response at Week 52.~time = 0 refers to Week 52"|Week 68|FAS|||Percent of participants||95% Confidence Interval|Number
2664169|NCT01544595|Secondary|Number of Participants With IGA Mod 2011 0/1 Response (Observed Data) - Entire Study Period|Investigator's Global Assessment (IGA) mod 2011 0/1. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions) Based on this scale, a patient was considered as IGA mod 2011 0/1 responder if the patient achieved a score of 0 or 1 and improved by at least 2 points on the IGA scale compared to baseline.|Week 52, Week 104, Week 156, week 208, week 260|FAS|||Number of participants|||Number
2664170|NCT01544595|Secondary|Number of Participants in Each IGA Mod 2011 Category (Observed Data) - Entire Study Period|Investigator's Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0= clear (no signs of psoriasis) Score 1 = almost clear no to minimal local scaling) Score 2 = mild (predominantly fine scaling) Score 3 = moderate (moderate scaling) Score 4 = severe (severe/coarse scaling covering almost all or all lesions)|Week 52, Week 104, Week 156, week 208, week 260|FAS|||Number of participants|||Number
2664171|NCT01544595|Secondary|Number of Participants in Each IGA Mod 2011 Category (Observed Data)- Randomized Withdrawal Period|"Investigator Global Assessment (IGA) mod 2011; scale from 0 - 4. Score 0: Clear (No signs of psoriasis. Post-inflammatory hyperpigmentation could be Present). Score 1: Almost clear (Normal to pink coloration of lesions; no thickening; no to minimal focal scaling), Score 2: Mild (Pink to light red coloration; just detectable to mild thickening; predominantly fine scaling). Score 3: Moderate (Dull bright red, clearly distinguishable erythema; clearly distinguishable to moderate thickening; moderate scaling). Score 4: Severe (Bright to deep dark red coloration; severe thickening with hard edges; severe /coarse scaling covering almost all or all lesions).~Patients in the placebo groups were not evaluable after re-treatment with Secukinumab"|Week 52 (baseline), 104, and 156|FAS|||Number of participants|||Number
2664172|NCT01544595|Secondary|Percent Change From Baseline for PASI Score Over Time (Observed Data) - Entire Study Period|Perc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included.|Week 52, Week 104, Week 156, week 208, week 260|FAS|||Percent change in PASI score||Standard Deviation|Mean
2664173|NCT01544595|Secondary|Percent Change From Baseline for PASI Score Over Time (Observed Data) - Randomized Withdrawal Period|"The improvement (decrease from baseline) in PASI total scores observed at Week 52.~Perc. change = 100 x Abs. change /Base. (Abs. change = Post - Base) For each post-baseline visit only patients with a value at both baseline and the respective post-baseline visit are included."|Week 52, 104, and 156|FAS|||Percent change in PASI score||Standard Deviation|Mean
2664174|NCT01544595|Secondary|Number of Participants With PASI 50, PASI 75, PASI 90, and PASI 100 (Observed Data) - Entire Study Period|Psoriasis Area and Severity Index (PASI) scoring system: The average degree of severity of each sign in each of the four body regions was assigned a score of 0-4. The area covered by lesions on each body region was estimated as a percentage of the total area of that particular body region.|Week 52, Week 104, Week 156, week 208, week 260|FAS|||Number of participants|||Number
2664175|NCT01544595|Secondary|Number of Participants With PASI 50, PASI 75, PASI 90, PASI 100 and IGA Mod 2011 0 or 1 (Observed Data) - Randomized Withdrawal Period|"Psoriasis Area and Severity Index (PASI) 75 responder at week 52. Patients in the placebo groups were not evaluable after re-treatment with Secukinumab.~PASI 75 Responders: patients with a PASI 75 response (patients achieving ≥75% improvement [reduction] in PASI score compared to baseline of the core study).~PASI 50 response: patients achieving ≥ 50% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 50 responders.~PASI 90 response: patients achieving ≥ 90% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 90 responders.~PASI 100 response/remission: complete clearing of psoriasis (PASI=0)"|Week 52, 104, and 156|FAS|||Number of participants|||Number
2664230|NCT01544179|Secondary|Improvement in Lung Cancer Subscale|An improvement is defined as a change from baseline of ≥ +2 (0-28 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL|||Number of participants improving|||Number
2664176|NCT01544595|Primary|Percent of Participants With Loss of Psoriasis Area and Severity Index (PASI) 75 Response up to Week 68|"The primary variable was the cumulative rate of patients who lost PASI 75 response up to Week 68 (time=0 being defined as Week 52).~Loss of PASI 75 response was analyzed by means of a survival analysis defining loss of PASI 75 response as failure. The term cumulative rate corresponded to 1 minus the survival function within this survival analysis, and the cumulative rate and the survival functions were dependent on time t.~PASI 75 response: patients achieving ≥ 75% improvement (reduction) in PASI score compared to baseline of the core study were defined as PASI 75 responders."|At week 68 (16 weeks after week 52)|Full analysis set (FAS): patients from randomized set with at least 1 post baseline efficacy assessment.|||Cummulative rate||95% Confidence Interval|Number
2664177|NCT01544582|Secondary|Incidence of Anemia, Grade 3/4 Neutropenia, Grade 3/4 Thrombocytopenia, and Serious Skin Rash|The incidence (events per 1000 participant-days) of the protocol-defined HOIs (anemia, grade 3/4 neutropenia, grade 3/4 thrombocytopenia, and serious skin rash) was calculated over the 48-week period following the start of CHC treatment exposure. All protocol-defined HOIs were taken into account (serious and non-serious HOIs). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The incidence per 1000 participant-days of anemia, grade 3/4 neutropenia, grade 3/4 thrombocytopenia, and serious skin rash were reported by CHC treatment group of exposure with 95% confidence intervals.|Up to 48 weeks of treatment|Participants in Analysis Population (CHC genotype-1 participants meeting eligibility criteria and treated with boceprevir+PR, telaprevir+PR, or PR alone) with available data who did not already experience HOI during 3 months preceding CHC treatment regimen. Participants categorized by treatment group of exposure further described in Arm Description|||events per 1000 participant-days||95% Confidence Interval|Number
2664178|NCT01544582|Primary|Percentage of Serious Rash Episodes Managed by Each Clinical Intervention Out of All Managed Episodes|"Clinical interventions used to manage episodes of serious rash in participants could include topical corticosteroid (TC), intravenous (IV) and/or oral (PO) corticosteroids (IV/PO CS), emollients/moisturizers (E/M), antihistamines (AH), other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).~For each CHC treatment exposure group, the percentage of serious rash episodes managed by a particular intervention are reported out of the total number of managed serious rash episodes with data available for that intervention (i.e. serious rash episodes with missing data for an intervention were excluded)."|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of serious rash. Participants categorized by treatment group of exposure (further described in Arm Description).|||percentage of episodes|Participants||Number
2664179|NCT01544582|Primary|Percentage of Serious Rash Episodes Managed by at Least One Clinical Intervention|Serious rash was considered a HOI for this study and included rash > 50% of body surface area, rash associated with significant systemic symptoms, or rash resulting in hospitalization or urgent care visit. Clinical interventions used to manage episodes of serious rash in participants could include topical corticosteroid use, intravenous (IV) and/or oral corticosteroids, emollients/moisturizers, antihistamines, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of serious rash episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of serious rash. Participants categorized by treatment group of exposure (further described in Arm Description).|||percentage of episodes|Participants|95% Confidence Interval|Number
2664180|NCT01544582|Primary|Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes|"Clinical interventions used to manage episodes of grade 3/4 thrombocytopenia in participants could include thrombopoietin (TPO), platelet transfusion (PT), other treatment (OT) , and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).~For each CHC treatment exposure group, the percentage of grade 3/4 thrombocytopenia episodes managed by a particular intervention are reported out of the total number of managed grade 3/4 thrombocytopenia episodes with data available for that intervention (i.e. grade 3/4 thrombocytopenia episodes with missing data for an intervention were excluded)."|Up to 48 weeks of a treatment regimen|Participants in Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 thrombocytopenia. Participants categorized by treatment group of exposure (further described in Arm Description).|||percentage of episodes|Participants||Number
2664186|NCT01544582|Primary|Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Grade for Child-Pugh Score|The Child-Pugh Score is used to determine the prognosis of chronic liver disease, in particular cirrhosis. It is classified into Classes A (best prognosis) to C (worst prognosis). Child-Pugh scores assessed within 3 months before CHC treatment regimen initiation were recorded from the eCRF, and the number of participants who were Grade A, Grade B, Grade C, not assessed, or unknown whether assessed were reported.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (Child Pugh score).|||participants|||Number
2664181|NCT01544582|Primary|Percentage of Grade 3/4 Thrombocytopenia Episodes Managed by at Least One Clinical Intervention|Grade 3/4 thrombocytopenia (Grade 3: platelet count 25 - <50 × 10^9/L, Grade 4: <25 × 10^9/L) was considered a HOI for this study. Clinical interventions used to manage episodes of grade 3/4 thrombocytopenia in participants could include thrombopoietin, platelet transfusion, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of grade 3/4 thrombocytopenia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.|Up to 48 weeks of a treatment regimen|Participants in Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 thrombocytopenia. Participants categorized by treatment group of exposure (further described in Arm Description).|||percentage of episodes|Participants|95% Confidence Interval|Number
2664182|NCT01544582|Primary|Percentage of Grade 3/4 Neutropenia Episodes Managed by Each Clinical Intervention Out of All Managed Episodes|"Clinical interventions used to manage episodes of grade 3/4 neutropenia in participants could include Granulocyte colony-stimulating factor (G-CSF) use, other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). More than one treatment modification could have been performed. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).~For each CHC treatment exposure group, the percentage of grade 3/4 neutropenia episodes managed by a particular intervention are reported out of the total number of managed grade 3/4 neutropenia episodes with data available for that intervention (i.e. grade 3/4 neutropenia episodes with missing data for an intervention were excluded)."|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 neutropenia. Participants categorized by treatment group of exposure (further described in Arm Description).|||percentage of episodes|Participants||Number
2664183|NCT01544582|Primary|Percentage of Grade 3/4 Neutropenia Episodes Managed by at Least One Clinical Intervention|Grade 3/4 neutropenia (Grade 3: neutrophil count 0.5 - <0.75 × 10^9/L, Grade 4: <0.5 × 10^9/L) was considered a HOI for this study. Clinical interventions used to manage episodes of grade 3/4 neutropenia in participants could include Granulocyte colony-stimulating factor (G-CSF) use and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of grade 3/4 neutropenia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of grade 3/4 neutropenia. Participants categorized by treatment group of exposure (further described in Arm Description).|||percentage of episodes|Participants|95% Confidence Interval|Number
2664184|NCT01544582|Primary|Percentage of Anemia Episodes Managed by Each Clinical Intervention Out of All Managed Anemia Episodes|"Clinical interventions used to manage episodes of anemia in participants could include erythropoiesis stimulating agent (ESA), blood transfusion (BT), other treatment (OT), and CHC treatment regimen modifications including drug dose reduction (DDR), drug discontinuation (DD), and drug interruption (DI). Interventions could be used in combination (e.g. ESA plus blood transfusion) and more than one treatment modification could have been performed. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive).~For each CHC treatment exposure group, the percentage of anemia episodes managed by a particular intervention are reported out of the total number of managed anemia episodes with data available for that intervention (i.e. anemia episodes with missing data for an intervention were excluded)."|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of anemia. Participants categorized by treatment group of exposure (further described in Arm Description).|||percentage of episodes|Participants||Number
2664185|NCT01544582|Primary|Percentage of Anemia Episodes Managed by at Least One Clinical Intervention|Anemia (hemoglobin <10 g/dL) was considered a Health Outcome of Interest (HOI) for this study. Clinical interventions used to manage episodes of anemia in participants could include erythropoiesis stimulating agent (ESA), blood transfusion, drug dose reduction, other treatment, and CHC treatment regimen modifications (drug dose reduction, drug discontinuation, and drug interruption). For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment groups were not mutually exclusive). The percentage of anemia episodes that were managed by at least one intervention is reported for each CHC treatment exposure group with 95% confidence intervals.|Up to 48 weeks of a treatment regimen|Participants in the Analysis Population (all CHC genotype-1 participants included on study meeting eligibility criteria and treated with boceprevir plus PR, telaprevir plus PR, or PR alone) who experienced at least one episode of anemia. Participants categorized by treatment group of exposure (further described in Arm Description).|||percentage of episodes|Participants|95% Confidence Interval|Number
2664227|NCT01544309|Primary|Change in HbA1c Level||Baseline, 12 months after administration|Participants in FAS except the ones who had no HbA1c data at 12 months.|||Amount of change (%)||Standard Deviation|Mean
2664228|NCT01544309|Primary|Percent Change in Non-high-density Lipoprotein Cholesterol (HDL-C) Level||Baseline, and 12 months after administration|Participants in full analysis set (FAS) except the ones who had no HDL-C data at 12 months.|||Percent change||Standard Deviation|Mean
2664187|NCT01544582|Primary|Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Viral Load|"Participant baseline HCV viral load was recorded from the eCRF and categorized as either Low (<800,000 IU/mL or <2,000,000 RNA copies/mL) or High (≥800,000 IU/mL or ≥2,000,000 RNA copies/mL)."|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (viral load).|||participants|||Number
2664188|NCT01544582|Primary|Baseline Disease Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Baseline Hepatitis C Virus (HCV) Genotype|Baseline HCV genotype was recorded from the eCRF and the number of participants who were 1a genotype, 1b genotype, or unknown/other was reported.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (HCV genotype).|||participants|||Number
2664189|NCT01544582|Primary|Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Body Mass Index (BMI)|Baseline mean body mass index (SD) in Kg/m^2 was recorded from the eCRF.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (BMI).|||Kg/m^2||Standard Deviation|Mean
2664190|NCT01544582|Primary|Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Height|Baseline mean height (SD) in centimeters (cm) was recorded from the eCRF.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (height).|||centimeters||Standard Deviation|Mean
2664191|NCT01544582|Primary|Baseline Characteristics of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone: Weight|Baseline mean weight (standard deviation [SD]) in kilograms (Kg) was recorded from the eCRF.|Before initiation of CHC treatment (Week 0 baseline)|Participants in the Analysis Population (all CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone) with available demographic data (weight).|||kilograms (Kg)||Standard Deviation|Mean
2664192|NCT01544582|Primary|Percentage of Participants Initiating Boceprevir Plus PR Treatment, Telaprevir Plus PR Treatment, or PR Treatment Alone (Drug Utilization Pattern)|The percentage of CHC participants initiating boceprevir plus PR treatment, telaprevir plus PR treatment, or PR treatment alone was determined from a Drug Utilization questionnaire that was administered to physicians using an electronic Case Report Form (eCRF) to collect site level information and reported with 95% confidence intervals.|Up to 37 months|Analysis Population: All CHC genotype-1 participants included in study meeting eligibility criteria and receiving boceprevir plus peginterferon and ribavirin (PR), telaprevir plus PR, or PR alone.|||percentage of participants||95% Confidence Interval|Number
2664193|NCT01544491|Secondary|To Evaluate Renal Function, Assessed by Glomerular Filtration Rate (eGFR) and Estimated by the Schwartz Formula (Extended), at Month 12|To evaluate renal function assessed by Glomerular Filtration Rate (eGFR) estimated by the Schwartz Formula (extended) (Schwartz, 2009). Results given as change from randomization|12 months post-transplantation|Full Analysis set 12 months months|||mL/min/1.73m2||Standard Deviation|Mean
2664194|NCT01544491|Secondary|Evaluation of Evolution of Renal Allograft Function Over Time|results given as eGFR values by time interval|baseline, 6 months, 12 months , 24 months, 36 months|full Analysis set 36 months|||ml/min/1.73m2||Standard Deviation|Mean
2664195|NCT01544491|Secondary|Growth/Development : Weight, Height, BMI : Change From Baseline|Evaluation of the potential effects upon the bone growth. The Z-score is a statistical tool which helps to assess data (here child growth parameters) relative to a reference or standard population. The Z-score describes the distance and direction of an observation away from the population median (or mean, however, here the median was used). A negative Z-score shows that data are lower than the median of the standard population, a positive Z-score shows that data are higher than the median of the standard population, and a Z-score of zero shows that the data are equal to the median of the standard population. The more the Z-score is distant from 0, the more expressed is for example underweight or overweight.|month 12 , month 36 post transplantation.|safety set, 36 months analysis|||z score||Standard Deviation|Mean
2664196|NCT01544491|Secondary|Proteinuria (Urinary Protein/Creatinine Ratio)|The urinary protein/creatinine ratio will be descriptively summarized by treatment group at each visit. The incidence rate of patients with proteinuria will be categorized in <0.2 g/mg/mg, 0.2<2.0 mg/mg and ≥ 2.0 mg/mg and summarized by treatment groups at each visit.|at 12 and 36 months post-transplantation|full analysis set 36 months analysis|||Participants|||Count of Participants
2664197|NCT01544491|Secondary|Chronic Allograft Nephropathy / Interstitial Fibrosis and Tubular Atrophy|To evaluate the proportion of patients with chronic allograft nephropathy (interstitial fibrosis and tubular atrophy, IF/TA) by histopathology and its progression.The term chronic allograft nephropathy was used inappropriately in the protocol and therefore, replaced by interstitial fibrosis and tubular atrophy|at 12 and 36 months post-transplantation.||||Participants|||Count of Participants
2664198|NCT01544491|Secondary|Incidence of Biopsy Proven Antibody Mediated Rejection.|To evaluate the proportion of patients with the following efficacy events: biopsy proven antibody mediated rejection/Steroid resistant BPAR and BPAR treated with T cell depleting therapy.|at 12 and 36 months post-transplantation|Full Analysis set|||Participants|||Count of Participants
2664199|NCT01544491|Secondary|To Evaluate the Time to Event of BPAR|Time to incidence of Event, given in terms of number of participants with an Event according to time interval up to 36 months|36 months|full Analysis set, 36 month analysis|||Participants|||Count of Participants
2664351|NCT01543958|Secondary|Change in Blood Phosphate Levels|Change in blood phosphate levels from baseline to week 8|Baseline to Week 8|Among 40 subjects enrolled in A5296, 37 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
2664200|NCT01544491|Secondary|To Evaluate the Severity of BPAR (Acute T-cell Mediated Rejection Only) (Banff 2009)|"T-cell mediated rejection severity :~Type IA - Significant interstitial infiltration (> 25% of parenchyma) and foci of moderate tubulitis (> 4 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IB - Significant interstitial infiltration (> 25% of parenchyma) and foci of severe tubulitis (> 10 mononuclear cells/tubular cross section or group of 10 tubular cells).~Type IIA - Mild to moderate intimal arteritis Type IIB - Severe intimal arteritis comprising > 25% of the lumenal area Type III - Transmural (full vessel wall thickness) arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells (with accompanying lymphocytic inflammation)"|month 12, month 36|full Analysis set 36 months|||Participants|||Count of Participants
2664201|NCT01544491|Secondary|Composite Efficacy Endpoint|To evaluate the proportion of patients with the following efficacy events: Biopsy Proven Acute Rejection (BPAR), graft loss or death. The efficacy events will be descriptively summarized by treatment group.|at 12 and 36 months post-transplantation|full Analysis set 36 month analysis Results given as number of participants with composite efficacy failures|||Participants|||Count of Participants
2664202|NCT01544491|Primary|To Evaluate Renal Function, Assessed by Glomerular Filtration Rate (eGFR) and Estimated by the Schwartz Formula (Abbreviated), at Month 12 and 36|To evaluate renal function assessed by Glomerular Filtration Rate (eGFR) estimated by the Schwartz Formula (abbreviated) (Schwartz, 2009).|12 months and 36 months post-transplantation|Full Analysis set 12 months and 36 months|||mL/min/1.73m2||Standard Error|Mean
2664203|NCT01544491|Primary|Number of Participants Having Reached the Composite Efficacy Endpoint of Biopsy-proven Acute Rejection|To estimate the rate of the composite efficacy endpoint of biopsy-proven acute rejection (BPAR), graft loss or death at 12 months post transplantation in primary paediatric kidney transplant recipients converted at 4-6 weeks post-transplantation from MMF + standard TAC regimen and steroids, to everolimus + reduced dose TAC regimen and steroid withdrawal at 6 months, versus continuation of MMF + standard TAC regimen and steroids.|12 months, 36 months|Full Analysis set (12 months and 36 months) Results given as number of participants with composite efficacy failures|||Participants|||Count of Participants
2664204|NCT01544478|Primary|Combined Incidence of Cervical Intraepithelial Neoplasia (CIN) 2/3 or Worse Related to Human Papillomavirus (HPV) Type 6, 11, 16, or 18|The endpoint included pathology panel consensus diagnosis of CIN 2 or 3, adenocarcinoma in situ, invasive squamous cervical carcinoma, or invasive adenocarcinoma of the cervix, and HPV type 6, 11, 16, or 18 detected in an adjacent section from the same tissue block. The point estimates and exact 95% confidence intervals for incidence rate were based on the Poisson distribution.|Up to Month 48|The population analyzed included participants who received the full vaccination series, had at least 1 visit after Month 7, had no general protocol violations, and were seronegative at Baseline and polymerase chain reaction-negative from Baseline through Month 7 for the relevant HPV type.|||Cases per 100 person-years at risk|Person-years at risk|95% Confidence Interval|Number
2664205|NCT01544361|Secondary|Number of Participants With Anti-Drug Antibodies (ADAs) for MEDI7814||Day 1, 29, 57, 85, and 106|Analyses of immunogenicity was not performed as the clinical development of MEDI7814 had been discontinued because the indication was no longer being pursued.||||||
2664206|NCT01544361|Secondary|Pharmacokinetic (PK) Parameters of MEDI7814|Individual MEDI7814 plasma concentration data and descriptive statistics of the PK parameters were to be tabulated by treatment group. Non-compartmental PK data analysis were to be performed for MEDI7814-treated participants to estimate PK parameters if data allowed.|Predose, end of infusion, 2, 6, 12 hours post-end of infusion on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 106|Analyses of PK was not performed as the clinical development of MEDI7814 had been discontinued because the indication was no longer being pursued.||||||
2664207|NCT01544361|Primary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 106 that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.|Day 1 to Day 106|Safety population included all randomized participants who received MEDI7814 and had safety data available.|||Participants|||Number
2664208|NCT01544348|Secondary|Free Immunoglobulin E (IgE) Serum Concentration||Day -28 (Screening), -1, 1 (pre-dose), 2, 3, 5, 8, 15, 22, 29, 43, 57, and 85 for all groups; 2 hours post-dose on Day 1 for MEDI4212 300 mg Intravenous group only|Safety population included all participants who received any amount of investigational product and had safety data available. 'n' signifies those participants who evaluable for this outcome measure at specified time point for each group, respectively.|||ng/mL||Standard Deviation|Mean
2664209|NCT01544348|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit|Anti-drug antibodies for MEDI4212 were analyzed for participants who received placebo or MEDI4212 as per planned analysis.|Days 1 (pre-dose), 15, 43, and 85|Immunogenicity population included all participants who received any investigational product and had at least one valid immunogenicity test result.|||participants|||Number
2664210|NCT01544348|Secondary|Observed Serum Concentration|Serum concentration of omalizumab and MEDI4212 were measured for participants who received omalizumab and MEDI4212, respectively.|Pre-dose and post-dose on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57 and 85|Pharmacokinetic (PK) population included all participants who received any investigational product and had a sufficient number of serum concentration measurements for computing PK parameters. Here 'n' signifies participants evaluable for this outcome measure at specified time point, for each group respectively|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2664229|NCT01544179|Secondary|Time to Worsening in Lung Cancer Subscale|A worsening is defined as a change from baseline of ≤ -2 (0-28 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL|||Weeks||95% Confidence Interval|Median
2664394|NCT01543568|Secondary|Average Time to Resolution of Intraretinal Cysts and Sub Retinal Fluid on OCT||6 months||||months||Full Range|Mean
2664211|NCT01544348|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 85 that were absent before treatment or that worsened relative to pre-treatment state.|Day 1 to 85|Safety population included all participants who received any amount of investigational product and had safety data available.|||participants|||Number
2664212|NCT01544309|Secondary|Change From Baseline in 1,5-AG Level|An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa|Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）||||μg/mL||Standard Deviation|Mean
2664213|NCT01544309|Secondary|Rate of Patients Who Have Reached the Target LDL-C Level Specified in Japan Atherosclerosis Society Guidelines (JASGL) 2007|Percentage of participants achieving the target LDL-C levels <100 mg/dL for participants with history of coronary artery diseases (CAD) and <120 mg/dL for participants without history of CAD are presented.|3 months after administration, the end of starting dose and the end of study treatment|Full analysis set except participants who have reached the target LDL-C level specified at the treatment start|||Percentage of participants||95% Confidence Interval|Number
2664214|NCT01544309|Secondary|Percent Changes in Lipids and Inflammatory Marker (Hs-CRP) and Their Correlation|Correlation between percent changes in lipids (LDL-C, HDL-C, non-HDL-C, TG, non-HDL-C/HDL-C ratio, LDL-C/HDL-C ratio, TC and FFA) and inflammatory marker (hs-CRP)|Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment|||||||
2664215|NCT01544309|Secondary|Percent Change in Non-HDL-C Level||Baseline, 3 and 6 months after administration, the end of starting dose and the end of study treatment|Participants in FAS except the ones who had no non-HDL-C level data at 12 months.|||Percent change||Standard Deviation|Mean
2664216|NCT01544309|Secondary|Percent Changes in Lipids (LDL-C, HDL-C, TC, TG, Non-HDL-C/HDL-C Ratio, and FFA)||Baseline, 3, 6, 12 months after administration, the end of starting dose and the end of study treatment|Participants in FAS except the ones who had no lipids level data at 12 months.|||Percent change||Standard Deviation|Mean
2664217|NCT01544309|Secondary|Frequency of Serious Adverse Events (SAE)||Up to 12 months||||Number of patients with SAE|||Number
2664218|NCT01544309|Secondary|Frequency of Cardiovascular Events (Coronary Artery Disease, Heart Failure, Cerebrovascular Disease, Peripheral Artery Disease and Aortic Disease)||From the start of the treatment to the end of study treatment||||Number of patients with any events|||Number
2664219|NCT01544309|Secondary|Change From Baseline in Insulin Level|An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa|Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）|Full analysis set - All participants who received at least 1 dose of open-label study drug.|||μU/mL||Standard Deviation|Mean
2664220|NCT01544309|Secondary|Percent Change in Insulin Level|An inverse relationship exists between mean change in insulin level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa.|Baseline, 3, 6, 12 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）|Full analysis set - All participants who received at least 1 dose of open-label study drug|||Percent change||Standard Deviation|Mean
2664221|NCT01544309|Secondary|Change in Blood Glucose Level (Fasting)||Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）||||mg/dL||Standard Deviation|Mean
2664222|NCT01544309|Secondary|Percent Change in Blood Glucose Level (Fasting)||Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）|Participants in FAS except the ones who had no blood glucose level data at 12 months.|||Percent change||Standard Deviation|Mean
2664223|NCT01544309|Secondary|Change in HbA1c Level||Baseline, 3, 6 months after administration and the end of study treatment （or at the occurrence of deterioration of diabetic treatment status）|Full analysis set - All participants who received at least 1 dose of open-label study drug.|||Amount of change (%)||Standard Deviation|Mean
2664224|NCT01544309|Secondary|Percent Change in 1,5-AG Level|An inverse relationship exists between mean change in 1,5-AG level and the mean rate of change when the degree of standard deviation is large, wherein the mean change is negative although the mean rate of change is positive or vice versa|Baseline, 3, 6, 12 months after administration and the end of study treatment（or at the occurrence of deterioration of diabetic treatment status）|Participants in FAS except the ones who had no 1,5-AG data at 12 months.|||Percent change||Standard Deviation|Mean
2664225|NCT01544309|Secondary|Number of Participants Stratified by Time to the Occurrence of Deterioration of Diabetic Treatment Status|"Deterioration of diabetic treatment status is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%."|Baseline, 3, 6, 12 months after administration|Full analysis set - All participants who received at least 1 dose of open-label study drug except the ones who had no HbA1c or non-HDL-C data or a protocol deviation of the administration of study drugs.|||participants|||Number
2664226|NCT01544309|Secondary|Occurrence of Deterioration of Diabetic Treatment Status|"Deterioration of diabetic treatment status is defined as addition of new drug, increase in dosage, drug changes (therapy intensification), and deterioration in HbA1c of > 0.5%."|Baseline, 12 months after administration|Full analysis set - All participants who received at least 1 dose of open-label study drug except the ones who had no HbA1c or non-HDL-C data or a protocol deviation of the administration of study drugs.|||Participants|||Number
2664395|NCT01543568|Secondary|Mean Change in OCT Central Foveal Thickness||6 Months||||micrometers||Full Range|Mean
2664231|NCT01544179|Secondary|Time to Worsening in FACT-L Total Score|A worsening is defined as a change from baseline of ≤ -6 (0-136 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL|||Weeks||95% Confidence Interval|Median
2664232|NCT01544179|Secondary|Improvement in FACT-L Total Score|An improvement is defined as a change from baseline of ≥ +6 (0-136 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL|||Number of patients improving|||Number
2664233|NCT01544179|Secondary|Time to Worsening in Trial Outcome Index|A worsening is defined as a change from baseline of ≤ -6 (0-84 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL|||Weeks||95% Confidence Interval|Median
2664234|NCT01544179|Secondary|Improvement in Trial Outcome Index|An improvement is defined as a change from baseline of ≥ +6 (0-84 score range). Measured by the Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) questionnaire.|At visits 2-8, then every 6 weeks until progression, at progression or treatment discontinuation, and every 8 weeks after progression until PFS analysis data cut off.|Evaluable-for-QoL|||Number of participants improving|||Number
2664235|NCT01544179|Secondary|Disease Control Rate (DCR)|DCR is the percentage of patients who achieve disease control at 6 weeks following randomisation. DCR is defined as a Best Objective Response (BOR) of Complete Response, Partial Response or Stable Disease, as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions; SD, neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for Progressive Disease (PD); PD, ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and the sum must have shown an absolute increase of ≥5mm|Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis.|Full analysis set|||Percentage of Participants|||Number
2664236|NCT01544179|Secondary|Objective Response Rate (ORR) (Site Read Data)|ORR rate is defined as the number (%) of subjects with at least one visit response of Complete Response (CR) or Partial Response (PR) , as defined by Response Evaluation Criteria in Solid Tumours (RECIST v1.1) for target lesions and assessed by CT or MRI. CR, Disappearance of all target lesions; PR, ≥30% decrease in the sum of the longest diameter of target lesions. Data obtained up until progression, or last evaluable assessment in the absence of progression, was included in the assessment of ORR.|Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis.|Full analysis set|||Percentage of Participants|||Number
2664237|NCT01544179|Secondary|Median Overall Survival (OS) at Time of PFS Analysis||Baseline and then every 6 weeks after randomization until objective disease progression. OS is then assessed 8 weekly following PFS progression up to PFS analysis data cut off.|Full analysis set|||Months||95% Confidence Interval|Median
2664238|NCT01544179|Secondary|Overall Survival (OS)|OS is the time from the date of randomisation until death due to any cause. Any subject not known to have died at the time of analysis will be censored based on the last recorded date on which the subject was known to be alive.|Following progression survival data was collected every 8 weeks until documentation of death, withdrawal of consent, loss to follow-up or the final data cut-off, whichever occurs first.|Full analysis set|||Number of patients with an OS event|||Number
2664239|NCT01544179|Primary|Median Progression-Free Survival (Site Read, Investigator Assessment)|PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.|Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks|Full analysis set (all treated patients)|||Months||95% Confidence Interval|Median
2664240|NCT01544179|Primary|Progression-Free Survival (Site Read, Investigator Assessment)|PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST (v1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm.|Radiologic evaluations were carried out every 6 weeks from randomization until documented progression, withdrawal of consent, loss to follow up, death or the primary data cut off (DCO) for the analysis, assessed up to 50 weeks|Full analysis set (all treated patients)|||Patients with a progression event|||Number
2664241|NCT01544166|Other Pre-specified|Number of Subjects With Drug Related Serious and Non- Serious Adverse Events|"An Adverse Event (AE) was any untoward medical occurrence in a subject who received study drug. A Serious AE (SAE) was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly, or deemed significant for any other reason. The drug-relatedness of AEs was determined by the Investigator based on his/her clinical decision based on all available information, and was based on the question whether there was a reasonable causal relationship to the study treatment."|From baseline to approximately 7 days after injection|SAF included all subjects who received any amount of gadobutrol.|||subjects|||Number
2664317|NCT01544062|Secondary|48 Hour Postoperative Opioid Consumption|48 hour postoperative opioid consumption will be obtained from the electronic medication administration record and expressed in morphine equivalents.|48 hours after arriving in ICU|Missing data for 1 study subject in normal saline group.|||mg||Standard Deviation|Mean
2664242|NCT01544166|Secondary|Estimated Glomerular Filtration Rate (eGFR) Prior to Gadobutrol Injection|eGFR was calculated based on the Schwartz formula with blood sampling for serum creatinine (Scr) not exceeding 14 days prior to gadobutrol injection. Otherwise, the eGFR was obtained from the original Schwartz formula: eGFR = k * height / Scr where k = 0.45 in term newborn infants < 1 year of age, and k = 0.55 in children up to 13 years of age. If Scr was measured by an enzymatic creatinine method that had been calibrated to be traceable to Isotope dilution mass spectroscopy (IDMS), the updated Schwartz formula was used: eGFR = 0.413*height/Scr.|Before gadobutrol injection|"SAF included all subjects who received any amount of gadobutrol. Here n included subjects who were evaluable at specified age group."|||milliliter/minute/1.73 square||Standard Deviation|Mean
2664243|NCT01544166|Secondary|Number of Subjects With Clinically Significant Abnormal Laboratory Values|Change in post-injection test values, such as resulting in a change in subject management or which were not the result of laboratory error and were considered clinically significant by the investigator was reported.|Baseline (not exceeding 24 hours before Gadobutrol injection) up to 24 hours post injection|Safety Analysis Set (SAF) included all subjects who received any amount of gadobutrol.|||subjects|||Number
2664244|NCT01544166|Secondary|Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region|"The subject management was indicated based on the unenhanced images alone. The analysis value for change in subject management was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664245|NCT01544166|Secondary|Number of Subjects With Change in Management From Unenhanced to Combined MRI|"The subject management was indicated based on the unenhanced images alone. The analysis value for change in subject management was recorded as yes/no. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664246|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region|"The analysis value for change in diagnosis was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664247|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis|"The analysis value for change in diagnosis was recorded as yes/no. Evaluation was done on pre- injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664248|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region|"The analysis value for change in diagnosis was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664249|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis|"The analysis value for change in diagnosis was recorded as yes/no. Evaluation was done on pre- injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664250|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region|"The analysis value for change in diagnosis was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664251|NCT01544166|Secondary|Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI|"The analysis value for change in diagnosis was recorded as yes/no. Evaluation was done on pre- injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664252|NCT01544166|Secondary|Number of Subjects With Final Diagnosis by Body Region|The final diagnosis of the subjects was based on all clinical information available and was provided separately within 4 weeks after MRI. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images. Only subjects with final diagnosis were reported.|Up to 4 weeks post-injection|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664253|NCT01544166|Secondary|Number of Subjects With Final Diagnosis|The final diagnosis of the subjects was based on all clinical information available and was provided separately within 4 weeks after MRI. Evaluation was done on pre-injection and combined (pre- and post- injection) images.|Up to 4 weeks post-injection|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664254|NCT01544166|Secondary|Number of Subjects With Confidence in Diagnosis by Body Region|Diagnostic confidence based on the unenhanced MRI image sets and thereafter on the combined MRI image sets were assessed on a 3-point scale, as 3 = Very confident, 2 = Confident, and 1 = Not confident. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664255|NCT01544166|Secondary|Number of Subjects With Confidence in Diagnosis|Diagnostic confidence based on the unenhanced MRI image sets and thereafter on the combined MRI image sets were assessed on a 3-point scale, as 1 = Not confident, 2 = Confident and 3 = Very confident. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664256|NCT01544166|Secondary|Number of Subjects With Additional Diagnostic Gain by Body Region|Additional diagnostic gain by the contrast-enhanced image set was assessed on a 3-point scale: scale 1 = Initial diagnosis unchanged, scale 2 = Initial diagnosis changed - improved, i.e. more specific, and scale 3 = Initial diagnosis changed -new diagnosis. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664257|NCT01544166|Secondary|Number of Subjects With Additional Diagnostic Gain|Additional diagnostic gain by the contrast-enhanced image set was assessed on a 3-point scale: scale 1 = Initial diagnosis unchanged, scale 2 = Initial diagnosis changed - improved, i.e. more specific, and scale 3 = Initial diagnosis changed -new diagnosis. Evaluation was done on combined (pre- and post- injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664258|NCT01544166|Secondary|Number of Subjects With Diagnoses by Body Region|The following diagnoses were reported for both the unenhanced MRI and the combined MRI image sets: Other diagnoses, No lesions/normal, Congenital disease/syndrome, Malignant lesion, Inflammation, Structural malformation, Benign lesion, and Vascular malformation. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664259|NCT01544166|Secondary|Number of Subjects With Diagnoses|The following diagnoses were reported for both the unenhanced MRI and the combined MRI image sets: Other diagnoses, No lesions/normal, Congenital disease/syndrome, Malignant lesion, Inflammation, Structural malformation, Benign lesion, and Vascular malformation. Evaluation was done on pre- injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664260|NCT01544166|Secondary|Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region|The degree of visualization of internal morphology and structure was recorded on a 3-point scale: 1 = Poor, the structure and internal morphology of the lesion or vessel is poorly visible; 2 = Moderate, the structure and internal morphology of the lesion or vessel is visible but sufficient information cannot be obtained; 3 = Good, the structure and internal morphology of the lesion or vessel is sufficiently visible for diagnostic purposes. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664261|NCT01544166|Secondary|Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement|The degree of visualization of internal morphology and structure was recorded on a 3-point scale: 1= Poor, the structure and internal morphology of the lesion or vessel is poorly visible; 2 = Moderate, the structure and internal morphology of the lesion or vessel is visible but sufficient information cannot be obtained; 3 = Good, the structure and internal morphology of the lesion or vessel is sufficiently visible for diagnostic purposes.Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664262|NCT01544166|Secondary|Number of Subjects With Border Delineation of Lesion of Vessel by Body Region|The border delineation for each lesion or vessel was recorded on a 4-point scale: 1 = None, no or unclear delineation of the boundary between the lesion or vessel and the surrounding tissue; 2 = Moderate, some aspects of border delineation covered; 3 = Good, almost clear delineation, but not complete on relevant slices; 4 = Excellent, clear and complete delineation.The results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664263|NCT01544166|Secondary|Number of Subjects With Border Delineation of Lesion of Vessel|The border delineation for each lesion or vessel was recorded on a 4-point scale: 1 = None, no or unclear delineation of the boundary between the lesion or vessel and the surrounding tissue; 2 = Moderate, some aspects of border delineation covered; 3 = Good, almost clear delineation, but not complete on relevant slices; 4 = Excellent, clear and complete delineation.Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664264|NCT01544166|Secondary|Contrast Enhancement in Lesion or Vessel by Body Region|The contrast-enhancement for each lesion or vessel was recorded on a 4-point scale: 1 = None, lesion or vessel is not enhanced; 2 = Moderate, lesion or vessel is weakly enhanced; 3 = Good, lesion or vessel is clearly enhanced; 4 = Excellent, lesion or vessel is clearly and brightly enhanced. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664265|NCT01544166|Secondary|Contrast Enhancement in Lesion or Vessel|The contrast-enhancement for each lesion or vessel was recorded on a 4-point scale: 1 = None, lesion or vessel is not enhanced; 2 = Moderate, lesion or vessel is weakly enhanced; 3 = Good, lesion or vessel is clearly enhanced; 4 = Excellent, lesion or vessel is clearly and brightly enhanced. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664266|NCT01544166|Secondary|Number of Subjects With Number of Lesions Detected by Body Region|"Presence of pathology included presence of lesions and was recorded as yes/no. If yes the number of subjects with specified lists of lesions and body region was reported. Evaluation was done on pre- injection and combined (pre- and post-injection) images. Data of subjects with missing number of lesions or at least one lesion in unenhanced and combined MRI sets were reported."|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation. 44 subjects in the FAS were analyzed. The number of subjects with presence of pathology was 33.|||subjects|||Number
2664267|NCT01544166|Secondary|Number of Subjects With Number of Lesions Detected|"Presence of pathology included presence of lesions and was recorded as yes/no. If yes the number of subjects with specified lists of lesions and body region was reported. Evaluation was done on pre- injection and combined (pre- and post-injection) images."|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation. 44 subjects in the FAS were analyzed. The number of subjects with presence of pathology was 33.|||subjects|||Number
2664268|NCT01544166|Secondary|Number of Subjects With Presence of Pathology by Body Region|"Presence of pathology was assessed for unenhanced and combined MRI sets and recorded as yes/no. The number of lesions identified for each MRI set was recorded. Results per body region were reported."|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664269|NCT01544166|Secondary|Number of Subjects With Presence of Pathology|"Presence of pathology was assessed for unenhanced and combined MRI sets and recorded as yes/no. The number of lesions identified for each MRI set was recorded."|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664270|NCT01544166|Secondary|Number of Subjects by Overall Contrast Quality by Body Region|A qualitative assessment of the overall contrast using the following pre-defined 5-point scale: 1= None (for example, in case of a non-enhancing vessel), 2= Poor, 3= Moderate, 4= Good, 5= Excellent, was done in the postcontrast MRI only, which is evaluated together with the unenhanced, this is why it is called combined. Data for combined MRI set was reported.|Images were taken post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664271|NCT01544166|Secondary|Number of Subjects by Overall Contrast Quality|A qualitative assessment of the overall contrast using the following pre-defined 5-point scale: 1= None (for example, in case of a non-enhancing vessel), 2= Poor, 3= Moderate, 4= Good, 5= Excellent, was done. This parameter was assessed in the postcontrast MRI only, which is evaluated together with the unenhanced, this is why it is called combined. Data for combined MRI set was reported.|Images were taken post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664272|NCT01544166|Secondary|Number of Subjects With Technical Adequacy for Diagnosis by Body Region|The technical adequacy of the the unenhanced image set and the combined unenhanced and enhanced image set was assessed based 4-point scale and body region. Four-point scale: 1=Region visualized with artifacts compromising quality and interpretability of images, 2=Only partial evaluation of images possible, region not covered adequately anatomically, 3=Region visualized with artifacts, partially compromising image quality but evaluation and diagnosis still possible, 4=Region clearly visualized, excellent quality. Evaluation was done on pre-injection and combined images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664273|NCT01544166|Secondary|Number of Subjects With Technical Adequacy for Diagnosis|The technical adequacy of the unenhanced image set and the combined unenhanced and enhanced image set was assessed based on the following 4 point scale: 1=Region visualized with artifacts compromising quality and interpretability of images, 2=Only partial evaluation of images possible, region not covered adequately anatomically, 3=Region visualized with artifacts, partially compromising image quality but evaluation and diagnosis still possible, 4=Region clearly visualized, excellent quality. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664274|NCT01544166|Secondary|Number of Subjects With Anatomical Area Evaluated|Subjects were referred for MRI of any body region. The primary anatomical area to be evaluated by MRI was assessed. Anatomical Area was recorded prior to gadobutrol injection for the unenhanced MRI procedure and after gadobutrol injection for the gadobutrol-enhanced MRI procedure. Evaluation was done on pre-injection and combined (pre- and post-injection) images.|Images were taken pre-injection and post-injection (within about 15 minutes)|Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.|||subjects|||Number
2664287|NCT01544127|Primary|Number of Participants With Suicidal Ideation|The number of participants with suicidal ideation and severity of suicidal ideation was measured using the Scale for Suicidal Ideation (SSI) at 1, 3, and 6 months after discharge. Scores range from 0-38, with scores of 1 or greater indicating the presence of suicidal ideation.|6 months|Analytical sample consists of participants who completed at least one follow-up.|||Participants|||Count of Participants
2664275|NCT01544166|Primary|Simulation of Plasma Concentration of Gadobutrol at 30 Minutes Post-Injection (C30)|Simulation is the use of the model to predict data other than observed data, in this case early Gadobutrol plasma concentration after intravenous injection. Plasma concentration serves as a surrogate for efficacy (signal and contrast enhancement) in MRI. C30 was simulated for virtual pediatric subjects with homogenous distribution over age. Simulated median (5th and 95th percentile in parenthesis) gadolinium plasma concentrations for a dose of 0.1 mmol/kg body weight were presented.|30 minutes post-injection|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample. C30 was simulated for 2400 virtual paediatric participants.|||micromole/L||Full Range|Median
2664276|NCT01544166|Primary|Simulation of Plasma Concentration of Gadobutrol at 20 Minutes Post-Injection (C20)|Simulation is the use of the model to predict data other than observed data, in this case early Gadobutrol plasma concentration after intravenous injection. Plasma concentration serves as a surrogate for efficacy (signal and contrast enhancement) in MRI. C20 was simulated for virtual pediatric subjects with homogenous distribution over age. Simulated median (5th and 95th percentile in parenthesis) gadolinium plasma concentrations for a dose of 0.1 mmol/kg body weight were presented.|20 minutes post-injection|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample. Here number of subjects analysed= 43. C20 was simulated for 2400 virtual paediatric participants.|||micromole/L||Full Range|Median
2664277|NCT01544166|Primary|Terminal Elimination Half-Life (t1/2) of Gadobutrol From Plasma: Individual|Half-life refers to the elimination of the drug, that is, the time it takes for the blood plasma concentration to reach half the concentration. Terminal elimination half-life of gadobutrol from plasma is expressed in hours and is derived from the terminal slope of the concentration versus time curve.|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.|||hours||Full Range|Median
2664278|NCT01544166|Primary|Mean Residence Time (MRT) of Gadobutrol in Plasma: Individual|MRT is the average time that the molecules introduced into the body stay in the body. MRT of Gadobutrol is expressed in hours.|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.|||hours||Full Range|Median
2664279|NCT01544166|Primary|Body Weight-Normalized Apparent Volume of Distribution at Steady State (Vss) of Gadobutrol in Plasma: Individual|Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.|||L/kg||Full Range|Median
2664280|NCT01544166|Primary|Body Weight-Normalized Total Body Clearance (CL) of Gadobutrol From Plasma: Individual|Clearance is the volume of the fluid presented to the eliminating organ that is effectively completely cleared of drug per unit time and depends on the rate of elimination. CL of gadobutrol normalized for body weight, was reported in Liter per hour per kilogram (L/(h*kg).|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.|||L/(h*kg)||Full Range|Median
2664281|NCT01544166|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Infinity of Gadobutrol: Individual|AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC from time 0 (start of injection) to infinity was reported in micromole*hour per liter (micromole*h/L).|Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol|Per-protocol set (PPS) included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.|||micromole*h/L||Full Range|Median
2664282|NCT01544153|Secondary|Self-reported 30-day Point Prevalence Abstinence|"In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding No, 30day point prevalence abstinence"|3 months post-randomization|Intent to treat|||Participants|||Count of Participants
2664283|NCT01544153|Primary|Self-reported 30-day Point Prevalence Abstinence|"In the past 30 days, have you smoked any cigarettes at all, even a puff? Number of participants responding No, 30day point prevalence abstinence."|9 months post-randomization|Intent to treat|||Participants|||Count of Participants
2664284|NCT01544127|Other Pre-specified|Number of Participants With a Suicide Attempt|Presence of a suicide attempt was measured with the Columbia Suicide Severity Rating Scale (C-SSRS) at 1, 3, and 6 months after discharge.|1, 3, and 6 months|All participants were entered into analyses and censored at suicide attempt or the last follow-up assessment. Follow-up assessments were completed by 122 participants.|||Participants|||Count of Participants
2664285|NCT01544127|Secondary|Number of Participants With Two Outpatient Mental Health or Substance Treatment Sessions|Treatment engagement was measured using the Treatment Services Review-6 (TSR-6) at 1 month after discharge.|1 month|Analyses were limited to participants who were immediately discharged to outpatient treatment.|||Participants|||Count of Participants
2664286|NCT01544127|Primary|Severity of Suicidal Ideation Among Those With It|Severity of suicidal ideation was measured by the Scale for Suicidal Ideation at 1, 3, and 6 months after discharge. Scores range from 0 to 38, with higher scores indicating more severe suicidal ideation.|6 months|Analyses were limited to the participants who reported suicidal ideation over follow-up.|||score on a scale||Standard Deviation|Mean
2664396|NCT01543568|Primary|The Number of Patients With no Fluid on OCT||6 months||||participants|||Number
2664288|NCT01544114|Secondary|PK of Naproxen: Trough Plasma Concentrations|Trough concentration was defined as lowest plasma concentration from pre-dose to 3 hours post-dose, for each individual participant.|Month 1 and Month 3: pre-dose, and up to 3 hours post-dose|PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2664289|NCT01544114|Secondary|PK of Esomeprazole: Oral Volume of Distribution (V/F)||pre-dose, and up to 3 hours post-dose|PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.|||L||Geometric Coefficient of Variation|Geometric Mean
2664290|NCT01544114|Secondary|PK of Esomeprazole: Absorption Rate Constant (Ka)||pre-dose, and up to 3 hours post-dose|PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.|||h^-1||Geometric Coefficient of Variation|Geometric Mean
2664291|NCT01544114|Secondary|PK of Esomeprazole: Oral Plasma Clearance (CL/F)||pre-dose, and up to 3 hours post-dose|PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2664292|NCT01544114|Secondary|Pharmacokinetics (PK) of Esomeprazole: Area Under the Concentration-Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC[0-t])||pre-dose, and up to 3 hours post-dose|PK Analysis Set: all participants who received at least 1 dose of study drug and had at least 1 post-baseline PK blood sample result and no protocol deviations that would have an impact on any PK assessment; participants were categorized according to the treatment medication they actually took.|||hr*µmol/L||Geometric Coefficient of Variation|Geometric Mean
2664293|NCT01544114|Primary|Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation (DC) of Study Drug|An AE is defined as the development of an undesirable medical condition or the deterioration of a preexisting medical condition, whether or not considered causally related to treatment. An SAE is defined as an AE occurring during any study phase (ie, run-in, treatment, washout, follow-up), that fulfils one or more of the following criteria: results in death; is immediately life-threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital abnormality or birth defect; is an important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. AEs were considered treatment-emergent if they occurred after the first dose of study drug. Events were categorized as mild, moderate, and severe; participants were represented only with the maximum reported intensity.|SAEs were collected from signing of informed consent through Month 6 (or end of treatment) plus 14 days. AEs were collected from administration of VIMOVO through Month 6 (or end of treatment) plus 14 days.|Safety analysis set: all participants who received at least 1 dose of study drug; participants were categorized according to the treatment medication they actually took.|||participants|||Number
2664294|NCT01544088|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self-report measure of general anxiety symptom severity. Total score range = 0-63; higher scores indicate greater symptom severity.|12 months||||units on a scale||Standard Deviation|Mean
2664295|NCT01544088|Secondary|Short-Form Health Survey (SF-36)|The SF-36 is a measure of functional impairment. Total score range = 0-200; higher scores indicate greater functioning.|12 months||||units on a scale||Standard Deviation|Mean
2664296|NCT01544088|Secondary|Beck Depression Inventory, II (BDI-II)|The BDI is a self-report inventory that indexes depression symptom severity. Total score range = 0-63; higher scores indicate greater symptom severity.|12 months||||units on a scale||Standard Deviation|Mean
2664297|NCT01544088|Primary|Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)|The CAPS-5 is a semi-structured interview to assess presence and severity of PTSD symptoms. The total score on the CAPS will be used as the primary outcome measure in this study. Total score range = 0-80; higher scores indicate greater symptom severity.|12 months|Primary treatment outcomes were examined using hierarchical linear modeling.|||units on a scale||Standard Deviation|Mean
2664298|NCT01544062|Secondary|48 Hour Dizziness|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of dizziness was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU|Missing data on 7 study subjects in normal saline group and 4 study subjects in IV acetaminophen group.|||participants|||Number
2664299|NCT01544062|Secondary|24 Hour Dizziness|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of dizziness was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.|||participants|||Number
2664300|NCT01544062|Secondary|48 Hour Respiratory Depression|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of respiratory depression was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU|Missing data on 6 study subjects in normal saline group and 3 study subjects in IV acetaminophen group.|||participants|||Number
2664301|NCT01544062|Secondary|24 Hour Respiratory Depression|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of respiratory depression was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.|||participants|||Number
2664302|NCT01544062|Secondary|48 Hour Sedation|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of sedation was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU|Missing data on 6 study subjects in normal saline group and 3 study subjects in IV acetaminophen group.|||participants|||Number
2664303|NCT01544062|Secondary|24 Hour Sedation|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of sedation was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.|||participants|||Number
2664304|NCT01544062|Secondary|48 Hour Pruritus|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of pruritus was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU|Missing data on 8 study subjects in normal saline group and 6 study subjects in IV acetaminophen group.|||participants|||Number
2664305|NCT01544062|Secondary|24 Hour Pruritus|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of pruritus was defined as numeric scale response 1 (mild adverse effects not requiring treatment), 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.|||participants|||Number
2664306|NCT01544062|Secondary|48 Hour Nausea|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of nausea was defined as numeric scale response 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|48 hours after arriving in ICU||||participants|||Number
2664307|NCT01544062|Secondary|24 Hour Nausea|Opioid related adverse effects were recorded using a numeric scale (0 = no adverse effects, 1 = mild adverse effects not requiring treatment, 2 = moderate adverse effects requiring treatment and 3 = severe adverse effects refractory to treatment). Presence of nausea was defined as numeric scale response 2 (moderate adverse effects requiring treatment) or 3 (severe adverse effects refractory to treatment).|24 hours after arriving in ICU||||participants|||Number
2664308|NCT01544062|Secondary|48 Hour Patient Satisfaction|"The extent to which subjects overall pain experience met their expectations question responses were converted to the Likert scale with the following values: not at all (1), a little (2), a fair amount (3), very much (4) and extremely well (5)."|48 hours after arriving in ICU|Questionnaire not completed by 12 study subjects in normal saline group and 10 study subjects in IV acetaminophen group.|||units on a scale||Standard Deviation|Mean
2664309|NCT01544062|Secondary|Length of ICU Stay|"The length of ICU stay will be determined based on the ICU Discharge Criteria checklist that will be completed by nursing staff every 4 hours until ICU discharge."|From the time of arrival in ICU until ICU discharge||||hours||Standard Deviation|Mean
2664310|NCT01544062|Secondary|Length of Mechanical Ventilation|"The length of mechanical ventilation will be determined based on the Extubation Criteria checklist that will be completed by nursing staff every 2 hours until extubation."|From the time of arrival in ICU until extubation||||minutes||Standard Deviation|Mean
2664311|NCT01544062|Secondary|48 Hour Wound Hyperalgesia|Wound hyperalgesia will be determined by testing the right side of the chest along five horizontal lines vertically separated by 2 cm at right angles to the incision using 180 gram von Frey filament (# 6.45).|48 hours after arriving in ICU|Missing data on 2 study subjects in normal saline group.|||cm||Standard Deviation|Mean
2664312|NCT01544062|Secondary|24 Hour Wound Hyperalgesia|Wound hyperalgesia will be determined by testing the right side of the chest along five horizontal lines vertically separated by 2 cm at right angles to the incision using 180 gram von Frey filament (# 6.45).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.|||cm||Standard Deviation|Mean
2664313|NCT01544062|Secondary|48 Hour Postoperative Pain Scores With Movement|Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).|48 hours after arriving in ICU|Missing data on 2 study subjects in normal saline group.|||units on a scale||Standard Deviation|Mean
2664314|NCT01544062|Secondary|24 Hour Postoperative Pain Scores With Movement|Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).|24 hours after arriving in ICU|Missing data on 3 study subjects in normal saline group.|||units on a scale||Standard Deviation|Mean
2664315|NCT01544062|Secondary|48 Hour Postoperative Pain Scores at Rest|Pain scores at rest will be recorded on Numeric Rating Scale by nursing staff. The Numeric Rating Scale ranges from 0 to 10 (0 - no pain, 1-2-3 - mild pain, 4-5-6 - moderate pain, 7-8-9 - severe pain, 10 - worst pain imaginable).|48 hours after arriving in ICU|Missing data on 2 study subjects in normal saline group.|||units on a scale||Standard Deviation|Mean
2664318|NCT01544062|Primary|24 Hour Postoperative Opioid Consumption|The 24 hour postoperative opioid consumption will be obtained from the electronic medication administration record and expressed in morphine equivalents.|24 hours after arriving in ICU|Missing data for 1 study subject in normal saline group.|||mg||Standard Deviation|Mean
2664319|NCT01544023|Secondary|Complication Rate|Secondary study outcome was the prevalence of complications.|2 years||||percentage of participants|||Number
2664320|NCT01544023|Primary|Participants Who Received TiLOOP Mesh Reconstruction|Primary study endpoint was the identification of patient- and surgical factors predictive of adverse outcome and to develop recommendations for patients eligible for implant based breast reconstruction (IBBR) using TCPM.|1 month||||Patients with TiLOOP mesh reconstruction|||Number
2664321|NCT01543958|Secondary|Primary Adverse Events|Number of subjects experiencing primary adverse events, defined as all reported Grade ≥ 2 signs and symptoms, Grade ≥ 2 laboratory abnormalities and other serious adverse events (SAEs)|baseline and week 16|All 40 subjects enrolled in A5296 were included in this analysis.|||participants|||Number
2664322|NCT01543958|Secondary|Change in Fasting Glucose|Change in fasting glucose from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
2664323|NCT01543958|Secondary|Change in Fasting Glucose|Change in fasting glucose from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
2664324|NCT01543958|Secondary|Change in Non-HDL Cholesterol|Change in non-HDL cholesterol from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
2664325|NCT01543958|Secondary|Change in Non-HDL Cholesterol|Change in non-HDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
2664326|NCT01543958|Secondary|Change in HDL Cholesterol|Change in fasting HDL cholesterol from week 8 to week 16|from week 8 to week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
2664327|NCT01543958|Secondary|Change in HDL Cholesterol|Change in fasting HDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
2664328|NCT01543958|Secondary|Change in LDL Cholesterol|Change in fasting LDL cholesterol from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 32 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
2664329|NCT01543958|Secondary|Change in LDL Cholesterol|Change in fasting LDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
2664330|NCT01543958|Secondary|Change in Total Cholesterol|Change in total cholesterol from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
2664331|NCT01543958|Secondary|Change in Total Cholesterol|Change in total cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
2664332|NCT01543958|Secondary|Change in Tissue Factor|Change in levels of coagulation biomarker tissue factor from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||pg/mL||Inter-Quartile Range|Median
2664333|NCT01543958|Secondary|Change in Tissue Factor|Change in levels of coagulation biomarker tissue factor from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 were included in this secondary analysis.|||pg/mL||Inter-Quartile Range|Median
2664334|NCT01543958|Secondary|Change in Tissue Factor|Change in levels of coagulation biomarker tissue factor from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 4 were included in this secondary analysis.|||pg/mL||Inter-Quartile Range|Median
2664335|NCT01543958|Secondary|Change in D-dimer|Change in levels of coagulation biomarker d-dimer from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||ng/mL||Inter-Quartile Range|Median
2664336|NCT01543958|Secondary|Change in D-dimer|Change in levels of coagulation biomarker d-dimer from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||ng/mL||Inter-Quartile Range|Median
2664337|NCT01543958|Secondary|Change in D-dimer|Change in levels of coagulation biomarker d-dimer from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 4 were included in this secondary analysis.|||ng/mL||Inter-Quartile Range|Median
2664338|NCT01543958|Secondary|Change in CRP|Changes in levels of systemic inflammation marker CRP from week 8 to week 16, where baseline is the average of pre-entry and entry|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||ng/mL||Inter-Quartile Range|Median
2664339|NCT01543958|Secondary|Change in CRP|Changes in levels of systemic inflammation marker CRP from baseline to week 8, where baseline is the average of pre-entry and entry|Baseline and Week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||ng/mL||Inter-Quartile Range|Median
2664340|NCT01543958|Secondary|Change in C-reactive Protein (CRP)|Changes in levels of systemic inflammation marker CRP from baseline to week 4, where baseline is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 4 were included in this secondary analysis.|||ng/mL||Inter-Quartile Range|Median
2664341|NCT01543958|Secondary|Change in IL-6|Changes in levels of systemic inflammation marker IL-6 from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||pg/mL||Inter-Quartile Range|Median
2664342|NCT01543958|Secondary|Change in IL-6|Changes in levels of systemic inflammation marker IL-6 from baseline to week 8, where baseline is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||pg/mL||Inter-Quartile Range|Median
2664343|NCT01543958|Secondary|Change in IL-6|Changes in levels of systemic inflammation marker IL-6 from baseline to week 4, where baseline is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All subjects had valid data at both baseline and week 4 and were included in this secondary analysis.|||pg/mL||Inter-Quartile Range|Median
2664344|NCT01543958|Secondary|Change in CD4+ T-cell Counts|Change in CD4+ T-cell counts from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||cells/mm^3||Inter-Quartile Range|Median
2664345|NCT01543958|Secondary|Change in CD4+ T-cell Counts|Change in CD4+ T-cell counts from baseline to week 8, where baseline is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 36 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||cells/mm^3||Inter-Quartile Range|Median
2664346|NCT01543958|Secondary|Change in CD4+ T-cell Counts|Change in CD4+ T-cell counts from baseline to week 4, where baseline is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at both baseline and week 4 were included in this secondary analysis.|||cells/mm^3||Inter-Quartile Range|Median
2664347|NCT01543958|Secondary|Change in log10 HIV RNA Levels|Change in log10 HIV RNA levels from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||log10(copies/mL)||Inter-Quartile Range|Median
2664348|NCT01543958|Secondary|Change in log10 HIV RNA Levels|Change in log10 HIV RNA levels from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in this secondary analysis.|||log10(copies/mL)||Inter-Quartile Range|Median
2664349|NCT01543958|Secondary|Change in log10 HIV RNA Levels|Change in log10 HIV RNA levels from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 4 and were included in this secondary analysis.|||log10(copies/mL)||Inter-Quartile Range|Median
2664350|NCT01543958|Secondary|Change in Blood Phosphate Levels|Change in blood phosphate levels from week 8 to week 16|from week 8 to week 16|Among 40 subjects enrolled in A5296, 34 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
2664352|NCT01543958|Secondary|Change in Blood Phosphate Levels|Change in blood phosphate levels from baseline to week 4, where baseline value is the average of pre-entry and entry|from baseline to week 4|Among 40 subjects enrolled in A5296, 39 subjects with valid data at both baseline and week 4 were included in this secondary analysis.|||mg/dL||Inter-Quartile Range|Median
2664353|NCT01543958|Secondary|Change in Proportion of Cycling CD4+|Change from week 8 to week 16 in cycling CD4+ , defined as the %Ki67+|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 29 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
2664354|NCT01543958|Secondary|Change in Proportion of Cycling CD4+|Change from baseline to week 8 in cycling CD4+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 32 subjects with valid data at both baseline and week 8 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
2664355|NCT01543958|Secondary|Change in Proportion of Cycling CD4+|Change from baseline to week 4 in cycling CD4+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 4 and were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
2664356|NCT01543958|Secondary|Change in Proportion of Cycling CD8+|Change from week 8 to week 16 in cycling CD8+ , defined as the %Ki67+|from week 8 to week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 29 subjects with valid data at both week 8 and week 16 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
2664357|NCT01543958|Secondary|Change in Proportion of Cycling CD8+|Change from baseline to week 8 in cycling CD8+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 32 subjects with valid data at baseline and week 8 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
2664358|NCT01543958|Secondary|Change in Proportion of Cycling CD8+|Change from baseline to week 4 in cycling CD8+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects have valid data at baseline and week 4 and were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
2664359|NCT01543958|Secondary|Change in CD8+ T-cell Activation|Change in CD8+ T-cell activation defined as the %CD38+/HLA-DR+ from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 30 subjects with valid data at week 8 and week 16 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
2664360|NCT01543958|Secondary|Change in CD8+ T-cell Activation|Change in CD8+ T-cell activation defined as the %CD38+/HLA-DR+ from baseline to week 8, where baseline is the average of pre-entry and entry|Baseline and Week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at baseline and week 8 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
2664361|NCT01543958|Secondary|Change in CD8+ T-cell Activation|Change from baseline to week 4 in CD8+ T-cell activation, defined as the %CD38+/HLA-DR+, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at baseline and week 4 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
2664362|NCT01543958|Secondary|Change in CD4+ T-cell Activation|Change from week 8 to week 16 in CD4+ T-cell activation, defined as the %CD38+/HLA-DR+|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 30 subjects with valid data at week 8 and week 16 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
2664363|NCT01543958|Secondary|Change in CD4+ T-cell Activation|Change from baseline to week 4 in CD4+ T-cell activation, defined as the %CD38+/HLA-DR+, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 35 subjects with valid data at baseline and week 4 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
2664364|NCT01543958|Secondary|Change in CD4+ T-cell Activation|Change from baseline to week 8 in CD4+ T-cell activation, defined as the %CD38+/HLA-DR+, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid data at baseline and week 8 were included in this secondary analysis.|||percentage||Inter-Quartile Range|Median
2664365|NCT01543958|Secondary|Change in sCD14|Change in sCD14 from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 34 subjects had valid data at both week 8 and week 16 and were included in this secondary analysis.|||ug/mL||Inter-Quartile Range|Median
2664366|NCT01543958|Secondary|Change in sCD14|Change in sCD14 from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects have valid data at baseline and week 4 and were included in this secondary analysis.|||ug/mL||Inter-Quartile Range|Median
2664367|NCT01543958|Secondary|Change in Endotoxin|Change in endotoxin from week 8 to week 16|week 8 and week 16|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. Among these 36 subjects, 33 subjects with valid endpoint at both week 8 and week 16 were included in this secondary analysis.|||pg/mL||Inter-Quartile Range|Median
2664368|NCT01543958|Secondary|Change in Endotoxin|Change in endotoxin from baseline to week 4, where baseline value is the average of pre-entry and entry|baseline and week 4|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 4 and were included in this secondary analysis.|||pg/mL||Inter-Quartile Range|Median
2664369|NCT01543958|Primary|Change in Soluble CD14 (sCD14)|Change in soluble CD14 (sCD14) from baseline to week 8, where baseline value is the average of pre-entry and entry|baseline and week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in primary analysis.|||ug/mL||Inter-Quartile Range|Median
2664370|NCT01543958|Primary|Change in Endotoxin|Change in LPS from baseline to week 8, where baseline value is the average of pre-entry and entry values.|baseline and Week 8|This is an as-treated analysis, limited to 36 subjects who have data for baseline and week 8 and who remain on study treatment through week 8. All 36 subjects had valid data at both baseline and week 8 and were included in primary analysis.|||pg/mL||Inter-Quartile Range|Median
2664371|NCT01543828|Primary|Time (in Minutes) to Patient's Perception of Onset of Effect|"Defined as the first time point that the patient responds yes to the following self-administered question:~I feel that the drug is working in improving my breathing?"|5, 7.5, 10, 15, 20, 30, 40, 50, and 60 minutes post dose for treatment 1 and treatment 2|Full Analysis Set included all participants who received one dose of study drug.|||Minutes||Standard Deviation|Mean
2664372|NCT01543776|Secondary|Peak Plasma Concentration of Abiraterone|Analyzed on a log scale due to skewness of distribution|Up to 4 months|Three patients had missing data.|||log(ng/mL)||Standard Error|Mean
2664373|NCT01543776|Secondary|Number of Participants With Adverse Events (AEs)|Patients with grade 3 or higher AE (CTCAE Version 4.03)|Assessed up to 1 year||||Participants|||Count of Participants
2664374|NCT01543776|Secondary|Adrenal Androgen Production (DHEA-S)|Extragonadal serum adrogen|Cycle 4 (4 months)|29 patients had missing data|||microgram per deciliter||Standard Error|Mean
2664375|NCT01543776|Secondary|Progression-free Survival (PFS)|Time to PSA progression (25% increase from baseline), radiographic progression, or death.|Assessed up to 3 years||||Months||95% Confidence Interval|Median
2664376|NCT01543776|Primary|Change in PSA Level|Data were analyzed on a log scale: log(week 12) - log(baseline) = log ratio. Smaller (more negative) values indicate a better outcome.|From baseline to 12 weeks|Two patients in each arm had missing data at 12 weeks.|||log ratio||Standard Error|Mean
2664377|NCT01543685|Secondary|TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 192 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 48 hours|Intent to Treat Population|||units on a scale*hour||Standard Deviation|Mean
2664378|NCT01543685|Secondary|TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 96 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 24 hours|Intent to Treat Population|||units on a scale*hour||Standard Deviation|Mean
2664379|NCT01543685|Secondary|TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 32 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 8 hours|Intent to Treat Population|||units on a scale*hour||Standard Deviation|Mean
2664397|NCT01543503|Secondary|Change From Baseline in Patient Global Assessment of Disease Activity|"The patient's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point|||scores on a scale||95% Confidence Interval|Least Squares Mean
2664380|NCT01543685|Secondary|Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4).|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 16 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 4 hours|Intent to Treat Population|||units on a scale*hour||Standard Deviation|Mean
2664381|NCT01543685|Secondary|VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as a time-weighted sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 24 hours|Intent to Treat Population|||mm*hour||Standard Deviation|Mean
2664382|NCT01543685|Secondary|VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 8 hours|Intent to Treat Population|||mm*hour||Standard Deviation|Mean
2664383|NCT01543685|Secondary|VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 4 hours|Intent to Treat Population|||mm*hour||Standard Deviation|Mean
2664384|NCT01543685|Primary|The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48)|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 48 hours|Intent to Treat Population|||mm*hour||Standard Deviation|Mean
2664385|NCT01543607|Secondary|Effectiveness: Change From Baseline in Bile Duct Diameter.|Effectiveness will be determined by change in stricture diameter (increase or decrease) after RFA procedure. This will be measure as percentage change in improvement of the stricture.|2 years||||percentage of improvement:|||Number
2664386|NCT01543607|Secondary|Feasibility: Ease of the Radiofrequency Ablation Catheter Placement|Determine the feasibility of radiofrequency ablation catheter placement across malignant strictures with using a subjective scale, 0 is being impossible to place the catheter and 10 is being very easy to place the catheter.|2 years||||units on a scale|||Number
2664387|NCT01543607|Primary|Safety: Number of Bile Leak After RFA Procedure|Determination of safety will be measured by the presence of a bile leak( bile leak will be defined by contrast cholangiography)|2 years||||bile leak|||Number
2664388|NCT01543581|Secondary|Complete Response Rate|A secondary variable is the complete response rate, defined as the proportion of patients with no histological evidence of basal cell carcinoma on the post treatment MMS excision of the target tumor area. For this analysis, the placebo data will be pooled together to calculate the complete response rate for the placebo group.|12 to 14 weeks||||participants|||Number
2664389|NCT01543581|Primary|Mohs Micrographic Surgery (MMS)|The final wound size taken immediately after the completion of Mohs surgery (i.e., upon reaching tumor-free tissue margins) was determined using pre treatment lesion outlined plus one additional concentric 2mm margin removed to establish an objective consistent measure for wound size. The diameter of the final wound size was measured in mm.|The Mohs surgical excision of the target tumor was performed within two weeks, after the last day of treatment.||||mm|||Number
2664390|NCT01543568|Secondary|Mean Number of 0.2 mg Aflibercept Injections Administered||at 6 months||||injections||Full Range|Mean
2664391|NCT01543568|Secondary|Quantitative Change in Area (μ) From Baseline in Choroidal Neovascular Lesion Characteristics/Size as Measured by FA/Fundus Photos||6 Months|Given lack of visual benefit upon switching to aflibercept (Eylea), such analyses were not performed.||||||
2664392|NCT01543568|Secondary|Mean Change in Visual Acuity (BCVA)|Change in Early Treatment of Diabetic Retinopathy Study Best Corrected Visual Acuity (ETDRS-BCVA) from baseline to month 6. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|6 Months||||ETDRS BCVA letters||Full Range|Mean
2664393|NCT01543568|Secondary|The Percentage of Patients Who Lose > 15 Letters Visual Acuity||6 Months||||Percentage of patients|||Number
2664398|NCT01543503|Secondary|Shift From Baseline in Morning Stiffness|Shift tables presenting the number of participants in each bivariate category Week (W) 0 versus Week 24 and Week 52, with regards to morning stiffness at the different time points, was presented for each treatment arm. For participants who experienced joint stiffness while waking up in the morning, duration of morning stiffness was categorized as follows: Less than 30 minutes (min), Between 30 and 60 minutes, Between 60 and 120 minutes, Between 120 to 240 minutes, More than 240 minutes and the whole day. Baseline = BL|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis.|||participants|||Number
2664399|NCT01543503|Secondary|Mean Change From Baseline in Visual Analogue Scale Pain Score|VAS is a 100 mm scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change from baseline =scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.|||units on a scale||95% Confidence Interval|Least Squares Mean
2664400|NCT01543503|Secondary|Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score|Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2664401|NCT01543503|Secondary|Mean Change From Baseline in Health Assessment Questionnaire Disability Index Score|The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2664402|NCT01543503|Secondary|Number of Participants With Serious and Non-serious Adverse Events of Special Interest, Including Infections, During the Study|Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events. Based on seriousness criteria, they were categorized as serious and non-serious adverse events of special interest.|Up to Week 52|The safety population was used for analysis.|||participants|||Number
2664403|NCT01543503|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Non-serious Adverse Events|An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Week 52|The safety population was used for analysis.|||participants|||Number
2664404|NCT01543503|Secondary|Number of Participants of Infusion Reactions or Injection Site Reactions During the Study Following the Start of the First Biologic Therapy|An infusion reaction was defined as an adverse event (AE) occurring during and within 24 hours after the infusion, which may include hypersensitivity reactions or anaphylactic reactions. Injection site reactions were included in the summaries for infusion reactions.|Up to Week 52|The safety population was used for analysis.|||participants|||Number
2664405|NCT01543503|Secondary|Cumulative Number of Participants Who Discontinued Biologic Therapy at the End of Each Study Period|The total number of participants who discontinued biologic therapy at the end of each study period (Week 0 - 24, Week 24 - 52, Week 52 - 57 and Week 57 - end of treatment) is presented. Participants who did not have a biologic therapy discontinuation or discontinued before having one, were considered as 'censored' at the date study termination.|Up to end of treatment|The safety population was used for analysis.|||participants|||Number
2664406|NCT01543503|Secondary|Reasons for Treatment Discontinuation|The reasons for discontinuation of tocilizumab or TNF inhibitor is presented.|Up to Week 52|The safety population was used for analysis.|||participants|||Number
2664407|NCT01543503|Secondary|Proportion of Participants Who Terminated Biologic Treatment|The proportion of participants who discontinued biologic treatment was compared between tocilizumab-treated and TNF inhibitor-treated participants.|Up to Week 52|The safety population was used for analysis.|||Percentage of participants|||Number
2664408|NCT01543503|Secondary|Loss of Efficacy or Development of Intolerance to Biologic Therapy|Events that are clearly consistent with the expected pattern of progression of the underlying disease may contribute to lack of efficacy. Lack of efficacy was one of the reasons for termination of biology therapy. The number of participants showing lack of efficacy to biologic therapy is presented.|Up to Week 52|The safety population included all recruited participants who received at least one dose of a TNF inhibitor or tocilizumab during the study.|||participants|||Number
2664439|NCT01543204|Secondary|Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).|Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data|||units on a scale||Standard Deviation|Mean
2664409|NCT01543503|Secondary|Mean Change From Baseline in Physician Global Assessment Score|"The Physician's Global Assessment of disease activity was assessed using a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). Change from baseline = scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement."|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.|||scores on a scale||95% Confidence Interval|Least Squares Mean
2664410|NCT01543503|Secondary|Mean Change From Baseline in Clinical Disease Activity Index and Simplified Disease Activity Index Score|Clinical Disease Activity Index (CDAI) was calculated as the sum of the following parameters: SJC + TJC + VAS Patient Global Assessment of Disease Activity + VAS Physician Global Assessment of Disease Activity. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity'. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. Simplified Disease Activity Index (SDAI) was calculated as the sum of the following parameters: SJC +TJC + Patient Global Assessment of Disease Activity + Physician Global Assessment of Disease Activity + CRP. SDAI scores ranged from 0 to 86, with higher scores also indicating increased disease activity.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.|||units on a scale||95% Confidence Interval|Least Squares Mean
2664411|NCT01543503|Secondary|Mean Change From Baseline in Tender Joint Count|A tender joint count (TJC) is the most specific clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.|||Number of tender joints||95% Confidence Interval|Least Squares Mean
2664412|NCT01543503|Secondary|Mean Change From Baseline in Swollen Joint Count|A swollen joint count (SJC) is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/ not swollen (0) giving a total possible SJC score of 0 to 28.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.|||Number of swollen joints||95% Confidence Interval|Least Squares Mean
2664413|NCT01543503|Secondary|Mean Change From Baseline in C-reactive Protein|Blood samples were collected for C-reactive protein (CRP). CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point|||mg/L||95% Confidence Interval|Least Squares Mean
2664414|NCT01543503|Secondary|Mean Change From Baseline in Erythrocyte Sedimentation Rate|Blood samples were collected for ESR, which is an acute phase reactant and a measure of inflammation. BL = baseline.|Baseline, Week 24, Week 52|The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.|||mm/hr||95% Confidence Interval|Least Squares Mean
2664415|NCT01543503|Secondary|Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52|Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient's Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker (ESR in mm/h, or CRP in mg/L). For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of </= 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 52|The effectiveness analysis population was used for analysis. Data of participants available at the time of the assessment were included in the analysis.|||units on a scale||95% Confidence Interval|Least Squares Mean
2664416|NCT01543503|Primary|Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24|Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient's Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker [erythrocyte sedimentation rate (ESR) in millimeter/hour (mm/h), or C-reactive protein (CRP) in milligram/liter (mg/L)]. For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of less than or equal to (</=) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.|Baseline and Week 24|Participants belonging to the safety population who had first biologic administration within 60 days after the last Rheumatoid Arthritis (RA) disease activity assessment were included in the effectiveness analysis population. Data of participants available at the time of the assessment were included in the analysis.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2664417|NCT01543204|Secondary|Number of Participants With Adverse Events|A treatment-related adverse event is defined as an event that is deemed by the investigator to be related to investigational product.|From first dose of study drug until 30 days after the last dose (up to 28 weeks)|Primary analysis set|||participants|||Number
2664418|NCT01543204|Secondary|Change From Baseline in Patient Assessment of Flaking|"The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their flaking, with 0 indicating no flaking at all and 10 indicating worst flaking imaginable. Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement."|Baseline and Week 12 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.|||units on a scale||Standard Deviation|Mean
2664419|NCT01543204|Secondary|Change From Baseline in Patient Assessment of Pain|"The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe how much their psoriasis hurts today, with 0 indicating does not hurt at all and 10 indicating worst hurt imaginable. Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement."|Baseline and Week 12 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.|||units on a scale||Standard Deviation|Mean
2664420|NCT01543204|Secondary|Change From Baseline in Patient Assessment of Itch|"The severity of the participants itch was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their itch, with 0 indicating no itch at all and 10 indicating worst itch imaginable. Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement."|Baseline and Week 12 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.|||units on a scale||Standard Deviation|Mean
2664421|NCT01543204|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI)|The impact of disease severity on the participant's ability to participate in work and other activities was evaluated using the WPAI. WPAI consists of six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.|Baseline and Weeks 12 and 24|Primary analysis set participants with at least 1 post-baseline value and who were employed (for the first 3 scores); LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.|||units on a scale||Standard Deviation|Mean
2664422|NCT01543204|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score|The dermatology life quality index (DLQI) is a skin disease-specific instrument to evaluate health-related quality of life. The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answered 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is from 0 (best possible score) to 30 (worst possible score). Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.|Baseline and Weeks 12 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used. n indicates the number of participants included in the analysis at each time point.|||units on a scale||Standard Deviation|Mean
2664423|NCT01543204|Secondary|Patient Satisfaction With Treatment at Week 24|"Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from very dissatisfied to very satisfied."|Week 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percentage of participants||95% Confidence Interval|Number
2664424|NCT01543204|Secondary|Patient Satisfaction With Treatment at Week 12|"Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from very dissatisfied to very satisfied."|Week 12|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percentage of participants||95% Confidence Interval|Number
2664425|NCT01543204|Secondary|Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status|A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data|||percent change||Standard Deviation|Mean
2664426|NCT01543204|Secondary|Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis|A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percent change||Standard Deviation|Mean
2664427|NCT01543204|Secondary|Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status|The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data|||percent change||Standard Deviation|Mean
2664440|NCT01543204|Secondary|Static Physician Global Assessment (sPGA) at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema).|Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2664428|NCT01543204|Secondary|Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)|The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percent change||Standard Deviation|Mean
2664429|NCT01543204|Secondary|Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data|||percentage of participants||95% Confidence Interval|Number
2664430|NCT01543204|Secondary|Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 2 grades is reported.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percentage of participants||95% Confidence Interval|Number
2664431|NCT01543204|Secondary|Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data|||percentage of participants||95% Confidence Interval|Number
2664432|NCT01543204|Secondary|Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with an improvement from baseline of ≥ 1 grade is reported.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percentage of participants||95% Confidence Interval|Number
2664433|NCT01543204|Secondary|Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit|A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data|||percentage of participants||95% Confidence Interval|Number
2664434|NCT01543204|Secondary|Percentage of Participants With a PASI 90 Response at Each Visit|A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percentage of participants||95% Confidence Interval|Number
2664435|NCT01543204|Secondary|Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit|A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data|||percentage of participants||95% Confidence Interval|Number
2664436|NCT01543204|Secondary|Percentage of Participants With a PASI 75 Response at Each Visit|A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percentage of participants||95% Confidence Interval|Number
2664437|NCT01543204|Secondary|Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit|A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data|||percentage of participants||95% Confidence Interval|Number
2664438|NCT01543204|Secondary|Percentage of Participants With a PASI 50 Response at Each Visit|A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.|Baseline and Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percentage of participants||95% Confidence Interval|Number
2664441|NCT01543204|Secondary|Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.|Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with available data|||percentage of participants||95% Confidence Interval|Number
2664442|NCT01543204|Secondary|Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.|Weeks 4, 8, 12, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percentage of participants||95% Confidence Interval|Number
2664443|NCT01543204|Secondary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Weeks 4, 8, 16, 20 and 24|Primary analysis set participants with available data|||percentage of participants||95% Confidence Interval|Number
2664444|NCT01543204|Secondary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Weeks 4, 8, 16, 20 and 24|Primary analysis set participants with at least 1 post-baseline value; LOCF imputation was used.|||percentage of participants||95% Confidence Interval|Number
2664445|NCT01543204|Primary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 12|The primary analysis set with available data|||percentage of participants||95% Confidence Interval|Number
2664446|NCT01543204|Primary|Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12|The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).|Week 12|The primary analysis set (all participants who received at least one dose of investigational product during the study) with at least 1 post-baseline value. Participants with missing post-baseline data were imputed using the last observation carried forward (LOCF) method.|||percentage of participants||95% Confidence Interval|Number
2664447|NCT01543178|Primary|Repeat Treatment Responders|Subjects who respond to repeat treatment in both IBS-related abdominal pain and stool consistency. The proportion of patients who responded to repeat treatment during the first double-blind repeat treatment phase is presented. Response is defined as improvement from baseline in abdominal pain AND reduction from baseline in diarrhea.|4-week treatment-free follow-up in double-blind repeat treatment phase.|Intent-to-treat population, defined as patients who received ≥ 1 dose of study drug in the double-blind period.|||percentage of patients|||Number
2664448|NCT01543087|Primary|Number of Days Participants Missed Work or School Due to AE From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 Through Visit 9)|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of days participants missed work or school due to AE occurred following booster vaccination were reported here.|From Visit 7 (time of booster vaccination, Month 48) Through Visit 9 (6 months after booster vaccination, Month 54)|"Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available. Here, “Overall number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."|||days||Standard Deviation|Mean
2664449|NCT01543087|Primary|Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Booster Vaccination|Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.|Within 30 minutes after Booster Vaccination in Month 48|Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available.|||percentage of participants||95% Confidence Interval|Number
2664450|NCT01543087|Primary|Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Booster Vaccine Through 26 Months After Booster Vaccination (Visit 7 to Visit 11)|An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC. Participants who received bivalent rLP2086 in primary study B1971012 on a 0-, 2-, and 6-month or a 0- and 6-month vaccination schedule were eligible to be follow up for 26 months after booster vaccination.|From Visit 7 (time of booster vaccination, Month 48) to Visit 11 (26 months after booster vaccination, Month 74)|"Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available. Here, “Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
2664473|NCT01543074|Primary|Cmax of Sulforaphane and Its Metabolites in Blood|"The levels of Sulforaphane and its metabolites (combined) in blood was measured using Liquid Chromatrography-Mass Spectrometry (LC-MS) methods. Cmax (mean +/- SD) values are shown in the Outcome Measure Data Table."|Before breakfast (0 hours) and 1, 3 and 6 hours after breakfast & pills on Days 1 & 7, and before breakfast on Days 8, 9 and 14.||||micromoles/L||Standard Deviation|Mean
2664525|NCT01542255|Primary|Progression Free Survival|Tumor evaluation will be performed every 8 weeks from day 1 of cycle 1 (+/- 1 week) while on therapy assessed by RECIST 1.0 criteria.|From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months||||weeks||Full Range|Median
2664451|NCT01543087|Primary|Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Booster Vaccination Through 26 Months After Booster Vaccination (Visit 8 to Visit 11)|An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC. Participants who received bivalent rLP2086 in primary study B1971012 on a 0-, 2-, and 6-month or a 0- and 6-month vaccination schedule were eligible to be follow up for 26 months after booster vaccination.|From Visit 8 (1 month after booster vaccination, Month 49) to Visit 11 (26 months after booster vaccination, Month 74)|"Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available. Here, “Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants||95% Confidence Interval|Number
2664452|NCT01543087|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From Booster Stage Vaccination Through 12 Months After Booster Vaccination (Visit 7 to Visit 10)|An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC.|From Visit 7 (time of booster vaccination, Month 48) to Visit 10 (12 months after booster vaccination, Month 60)|Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available.|||percentage of participants||95% Confidence Interval|Number
2664453|NCT01543087|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Booster Vaccination Through 12 Months After Booster Vaccination (Visit 8 to Visit 10)|An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC.|From Visit 8 (1 month after booster vaccination, Month 49) to Visit 10 (12 months after booster vaccination, Month 60)|Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available.|||percentage of participants||95% Confidence Interval|Number
2664454|NCT01543087|Primary|Percentage of Participants With Newly Diagnosed Chronic Medical Condition;(NDCMC) From the 6-Month Safety Telephone Call in the Primary Study Through 48 Months After the Last Dose in the Primary Study (Visit 6 in Stage 1)|An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC.|Visit 1 of B1971033 (6-month safety telephone call after last dose in primary study) to Visit 6 of B1971033 (6 months after last primary dose to 48 months after last primary dose in primary study)|Stage 1 safety population included all participants who had at least 1 blood draw in the study.|||percentage of participants||95% Confidence Interval|Number
2664455|NCT01543087|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 to Visit 9)|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An MAE was defined as a nonserious AE (AE other than SAE) that resulted in an evaluation at a medical facility.|From Visit 7 (time of booster vaccination, Month 48) to Visit 9 (6 months after booster vaccination, Month 54)|Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.|||percentage of participants||95% Confidence Interval|Number
2664456|NCT01543087|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Follow-Up Phase (Visit 8 to Visit 9)|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility.|Visit 8 (Month 49) to Visit 9 (Month 54) in Booster stage|Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.|||percentage of participants||95% Confidence Interval|Number
2664457|NCT01543087|Primary|Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8)|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious AEs and serious adverse events (SAEs). An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility.|From Visit 7 (Month 48) to Visit 8 (Month 49) in Booster stage|Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.|||percentage of participants||95% Confidence Interval|Number
2664475|NCT01542957|Secondary|Change From Baseline in Hamilton-Depression Rating Scale-17 Items|This clinician-administered measure was only applied to 78 patients at pre- and posttreatment. It measures severity of depressive symptoms. The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 54, with higher scores indicating more severity of depressive symptoms.|End of therapy and 12-month follow-up|The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified.|||units on a scale||Standard Deviation|Mean
2664458|NCT01543087|Primary|Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination|Systemic reactions included: fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site and joint pain, all other systemic reactions were recorded by using an e-diary. Fever was categorized as: 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and > 40.0 degree C. Vomiting was graded as: mild (1 to 2 times in 24 hours [hrs]), moderate (>2 times in 24 hrs) and severe (requires intravenous [IV] hydration); Diarrhea was graded as: mild (2 to 3 loose stools in 24 hrs), moderate (4 to 5 loose stools in 24 hrs) and severe (6 or more loose stools in 24 hrs); Headache, fatigue, chills, muscle pain and joint pain was graded as: mild (does not interfere with daily activities), moderate (some interference with activity) and severe (prevents daily routine activity).|Within 7 days after booster vaccination on Month 48|Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.|||percentage of participants||95% Confidence Interval|Number
2664459|NCT01543087|Primary|Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination|Local reactions were collected by using an e-diary and included pain at injection site, redness and swelling. Redness and swelling were graded as: none (0-2.0 centimetre [cm]), mild (2.5-5.0 cm), moderate (greater than [>] 5.0-10.0 cm) and severe (>10.0 cm). Pain was graded as: mild (does not interfere with activity), moderate (Interferes with activity) and severe (prevents daily activity).|Within 7 days after booster vaccination on Month 48|Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.|||percentage of participants||95% Confidence Interval|Number
2664460|NCT01543087|Primary|Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to(>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 26 Months After the Booster Vaccination(Visit 11)|For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage. only participants who received bivalent rLP2086 in primary study B1971010 were not analysed for this endpoint. Only participants who received bivalent rLP2086 in primary study B1971012 on a 0-, 2-, and 6-month or a 0- and 6-month vaccination schedule were eligible to be followed for 26 months after booster vaccination|Visit 11 (26 months following the booster vaccination on Month 74)|Evaluable population:eligible participants who received scheduled investigational products, received no prohibited vaccines or treatment, had pre and post vaccination blood drawn with valid, determinate assay results and had no important protocol deviation. ’Number analyzed’=number of participants with valid,determinatehSBA titers for given strain.|||percentage of participants||95% Confidence Interval|Number
2664461|NCT01543087|Primary|Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10)|For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage.|Visit 10 (12 months following the booster vaccination on Month 60)|Evaluable population:eligible participants who received scheduled investigational products, received no prohibited vaccines or treatment, had pre and post vaccination blood drawn with valid, determinate assay results and had no important protocol deviation. ’Number analyzed’=number of participants with valid,determinatehSBA titers for given strain.|||percentage of participants||95% Confidence Interval|Number
2664462|NCT01543087|Primary|Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8)|For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage.|Visit 8 (1 month following the booster vaccination on Month 49)|Evaluable population:eligible participants who received scheduled investigational products, received no prohibited vaccines or treatment, had pre and post vaccination blood drawn with valid, determinate assay results and had no important protocol deviation. ’Number analyzed’=number of participants with valid,determinatehSBA titers for given strain.|||percentage of participants||95% Confidence Interval|Number
2664463|NCT01543087|Primary|Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6])|For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage.|Visit 6 of study B1971033 (48 months after last vaccination in primary study)|Evaluable population:eligible participants who received scheduled investigational products, received no prohibited vaccines or treatment, had pre and post vaccination blood drawn with valid, determinate assay results and had no important protocol deviation. ’Number analyzed’=number of participants with valid,determinatehSBA titers for given strain.|||percentage of participants||95% Confidence Interval|Number
2664474|NCT01542957|Secondary|Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up|To assess subjective well-being, symptoms or problems, life functioning, and risk. The Total score is reported, which is the sum of the ratings of all items divided by the number of items (34). The score and ranges from 0 to 4, with higher scores indicating more severity of psychological distress.|End of therapy, 3 and 12 month follow-up|The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified|||units on a scale||Standard Deviation|Mean
2664561|NCT01541891|Primary|Tear Film Break-up Time (TBUT)|TBUT was evaluated at baseline and end of the study|During 60 days||||seconds||Standard Deviation|Mean
2664464|NCT01543087|Primary|Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study|For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage.|1 month after last vaccination in primary study|Evaluable population:eligible participants who received scheduled investigational products, received no prohibited vaccines or treatment, had pre and post vaccination blood drawn with valid,determinate assay results and had no important protocol deviation. ’Number analyzed’=number of participants with valid,determinate hSBA titers for given strain.|||percentage of participants||95% Confidence Interval|Number
2664465|NCT01543087|Primary|Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations|For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).|Month 48 (Visit 6 of study B1971033)|mITT population included participants who had at least 1 valid and determinate assay result in Stage 1 of Study B1971033. Here, ’Number analyzed’ signifies number of participants with valid and determinate hSBA titers for the given strain.|||percentage of participants||95% Confidence Interval|Number
2664466|NCT01543087|Primary|Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations|For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).|Month 36 (Visit 5 of study B1971033)|mITT population included participants who had at least 1 valid and determinate assay result in Stage 1 of Study B1971033. Here, ’Number analyzed’ signifies number of participants with valid and determinate hSBA titers for the given strain.|||percentage of participants||95% Confidence Interval|Number
2664467|NCT01543087|Primary|Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations|For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).|Month 24 (Visit 4 of study B1971033)|mITT population included participants who had at least 1 valid and determinate assay result in Stage 1 of Study B1971033. Here, ’Number analyzed’ signifies number of participants with valid and determinate hSBA titers for the given strain.|||percentage of participants||95% Confidence Interval|Number
2664468|NCT01543087|Primary|Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations|For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).|Month 18 (Visit 3 of study B1971033)|mITT population included participants who had at least 1 valid and determinate assay result in Stage 1 of Study B1971033. Here, ’Number analyzed’ signifies number of participants with valid and determinate hSBA titers for the given strain.|||percentage of participants||95% Confidence Interval|Number
2664469|NCT01543087|Primary|Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations|For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 % CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).|Month 12 (Visit 2 of study B1971033)|mITT population included participants who had at least 1 valid and determinate assay result in Stage 1 of Study B1971033. Here, ’Number analyzed’ signifies number of participants with valid and determinate hSBA titers for the given strain.|||percentage of participants||95% Confidence Interval|Number
2664470|NCT01543087|Primary|Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations|For immunogenicity assessment, serum bactericidal assay using human complement (hSBA) was performed with 4 primary Neisseria meningitidis serogroup B (MnB) test strains. Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95 percent (%) confidence interval (CIs). LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Participants who received bivalent rLP2086 in primary study B1971012, entered in this study at Month 12 (Visit 2). Hence, no participants enrolled from primary study B1971012 had serology results at Month 6.|Month 6 (Visit 1 of study B1971033)|Modified intent-to-treat (mITT) population included participants who had at least 1 valid and determinate assay result in Stage 1 of Study B1971033. Here, ’Number analyzed’ signifies number of participants with valid and determinate hSBA titers for the given strain.|||percentage of participants||95% Confidence Interval|Number
2664471|NCT01543074|Secondary|Histone Acetylation|"Histone acetylation was measured by immunoblotting the levels of acetylated histone H4K12 in the circulating peripheral blood mononuclear cells (PBMCs) of subjects who consumed either placebo, garlic oil, BSE, or BSE+garlic oil. The fold increase in acetylated histone H4K12 in the different groups is shown in the Outcome Measure Data Table."|6 h|The data were obtained by analyzing 'representative' patient samples (n=3 per group) using immunoblotting.|||Fold change||Standard Deviation|Mean
2664472|NCT01543074|Primary|Tmax of Sulforaphane and Its Metabolites in Blood|"The levels of Sulforaphane and its metabolites (combined) in blood was measured using Liquid Chromatrography-Mass Spectrometry (LC-MS) methods. The time to achieve highest plasma concentration (Tmax) is shown in the Outcome Measure Data Table."|Before breakfast (0 hours) and 1, 3 and 6 hours after breakfast & pills on Days 1 & 7, and before breakfast on Days 8, 9 and 14.||||hours||Standard Deviation|Mean
2664476|NCT01542957|Primary|Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up|To assess change in severity of depressive symptoms. The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 63, with higher scores indicating more severity of depressive symptoms.|End of therapy (16 weeks), 3 and 12-month follow-up|The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified|||units on a scale||Standard Deviation|Mean
2664477|NCT01542788|Secondary|Percentage of Participants Experiencing Viral Relapse|Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement|End of treatment to post-treatment Week 24|Participants in the Full Analysis Set who had an end-of-treatment response (HCV RNA < LLOQ as the last observed on-treatment value) were analyzed.|||percentage of participants|||Number
2664478|NCT01542788|Secondary|Percentage of Participants Experiencing Viral Breakthrough|Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values|Baseline to Week 12|Full Analysis Set|||percentage of participants|||Number
2664479|NCT01542788|Secondary|Percentage of Participants Achieving SVR24|SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy|Post-treatment Week 24|Full Analysis Set|||percentage of participants|||Number
2664480|NCT01542788|Secondary|Percentage of Participants Achieving SVR4|SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy|Post-treatment Week 4|Full Analysis Set|||percentage of participants|||Number
2664481|NCT01542788|Primary|Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug|The number of subjects experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment.|Baseline to Week 12|Safety Analysis Set: participants were randomized and received at least 1 dose of study drug|||participants|||Number
2664482|NCT01542788|Primary|Percentage of Participants Achieving SVR12|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy|Post-treatment Week 12|Full Analysis Set: participants with genotype 2 or 3 HCV infection who were randomized into the study and received at least 1 dose of study drug|||percentage of participants|||Number
2664483|NCT01542684|Primary|Overall Response Rate (ORR)|ORR is percentage total participants with overall response (Complete Response (CR) or Partial Response (PR)) within two treatment cycles. Response based on modified International Working Group (IWG) criteria: Complete response - Bone marrow: 5% myeloblasts with normal maturation of all cell lines, Persistent dysplasia noted, Peripheral blood Hgb 11 g/dL, Platelets 100x109/L, Neutrophils 1.0x109/L, Blasts 0%. Partial response: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by 50% over pretreatment but still > 5% , Cellularity and morphology not relevant; Stable disease - Failure to achieve at least PR, but no evidence of progression for > 8 weeks; No Response or Failure - Death during treatment or disease progression characterized by worsening of cytopenias, increase in percentage of bone marrow blasts, or progression to a more advanced MDS French-American-British (FAB) classification subtype than pretreatme|Baseline up to 2 treatment cycles (8 weeks)||||percentage of participants|||Number
2664484|NCT01542645|Secondary|12 Months-Chronic Pain-weekly Frequency of Pain|0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant|12 months|A home postal survey was sent to participants in the clinical trial 12 month after surgery. 31 patients in the methadone group and 34 patients in the fentanyl group returned the surveys|||score on a scale||Inter-Quartile Range|Median
2664485|NCT01542645|Secondary|6 Months-Chronic Pain-weekly Frequency of Pain|0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant|6 months|A home postal survey was sent to participants in the clinical trial 6 months after surgery. 42 patients in the methadone group and 39 patients in the fentanyl group returned the surveys|||score on a scale||Inter-Quartile Range|Median
2664486|NCT01542645|Secondary|3 Months-Chronic Pain-weekly Frequency of Pain|0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant|3 months|A home postal survey was sent to participants in the clinical trial 3 months after surgery. 46 patients in the methadone group and 54 patients in the fentanyl group returned the surveys|||score on a scale||Inter-Quartile Range|Median
2664487|NCT01542645|Secondary|Marker of Myocardial Injury (Troponin I)|In a cohort of patients undergoing only coronary artery bypass graft surgery (n=75), serum troponins will be measured postoperatively to determine whether methadone has a potential cardioprotective effect.|12 hours after surgery||||nanograms per millimeter||Full Range|Median
2664488|NCT01542645|Secondary|Chronic Postoperative Pain Scores-Weekly Frequency of Pain|0=< once per week; 1=once per week; 2=twice per week; 3=daily; 4=constant|1 months after surgery|A home postal survey was sent to participants in the clinical trial 1 month after surgery. 46 patients in the methadone group and 58 patients in the fentanyl group returned the surveys|||score on a scale||Inter-Quartile Range|Median
2664489|NCT01542645|Secondary|Postoperative Pain Scores|Pain was assessed on a 11-point verbal analogue scale with 0=no pain, 10=worst pain imaginable|2 hours after cardiac surgery||||units on a scale||Full Range|Median
2664490|NCT01542645|Primary|Total Opioid Consumption in the Postoperative Period|Total intravenous morphine used first three days (72 hours after ICU admission)|First 3 days after surgery||||milligrams||Full Range|Median
2664491|NCT01542632|Primary|Rate of Seroconversion to Each of Four Dengue Serotypes|Rate of seroconversion was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plagues (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.|Up to 30 days after the last immunization (Up to Day 120)|Participants from the Full Analysis Set, all enrolled participants, with data available at the given time-point.|||percentage of participants|||Number
2664492|NCT01542632|Secondary|Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes||Days 30, 90 and 120 after 1st vaccination|Participants from the Full Analysis, all enrolled participants, with data available for analysis at the given time-point.|||titer||Standard Deviation|Geometric Mean
2664493|NCT01542632|Primary|Number of Participants With at Least 1 Adverse Events Related to TDV Following Either Vaccine Dose|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. Some AEs are automatically considered related because of temporal relationship to vaccination.|For 30 days after each dose (Up to Day 120)|Safety Population included all enrolled participants who received at least one dose of study drug.|||participants|||Number
2664494|NCT01542632|Primary|Number of Participants With at Least 1 Adverse Event Following Either Vaccine Dose|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.|For 30 days after each dose (Up to Day 120)|Safety Population included all enrolled participants who received at least one dose of study drug.|||participants|||Number
2664495|NCT01542632|Secondary|Percentage of Participants With Serotype-Specific TDV Viral RNA Detected After First and Second Vaccinations|Serotype-Specific TDV Viral RNA was assessed for the four dengue serotypes: Dengue-1, Dengue-2, Dengue-3 and Dengue-4 . Only those serotypes and time-points where at least 1 participant had Serotype-Specific TDV Viral RNA Detected is reported.|various timepoints up to 30 days after each dose (Up to Day 120)|Full Analysis Set included all enrolled participants.|||percentage of participants|||Number
2664496|NCT01542632|Primary|Number of Participants With Injection Site Reactions Following Either Vaccine Dose Worst Severity Reported|Erythema and Edema Were Graded Per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Where Grade 0=none to Grade 4=Severe. Pain and Itching were graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where Grade 0=no pain or itching to Grade 4= Life-threatening/severe. Only those score categories for which there was at least 1 participant are reported.|Day 0 to Day 104|Safety population included all enrolled participants who received at least one dose of study drug.|||participants|||Number
2664497|NCT01542541|Secondary|SUVavg in Each Colonic Segment||Day 2||||SUV||Standard Deviation|Mean
2664498|NCT01542541|Primary|SUVmax of FDG in Each Colonic Segment||Day 2||||SUV||Standard Deviation|Mean
2664499|NCT01542528|Secondary|Overall Improvement|Clinical Global Improvement Scale (CGI-I) - responders vs. non-responders. CGI is a seven point scale with the following anchor point: 1=Very Much Improved, 2=Much Improved, 3=Improved, 4=No change, 5=Minimally worse, 6=Much worse, 7=Very much worse. Participants with a score of 1, 2, or 3 at Endpoint were considered Responders; all others were considered non-responders.|15 weeks for a total of 60 IBBS sessions vs. treatment as usual (TAU)|The analysis population are those with matched cases at 15 weeks.|||Percentage of participants|||Number
2664500|NCT01542528|Primary|Improvement in ADHD Severity From Baseline to End of Intervention|ADHD severity was measured by the Swanson, Nolan, and Pelham Rating Scale (SNAP)-IV-ADHD consists of 18 items that closely parallel in wording the diagnostic symptoms for ADHD as they appear in the DSM-IV. The range of scores are from 0 to 54. Higher scores indicate greater ADHD severity . The blinded assessors (Clinicians) used clinical judgement to provide an overall rating, based on all available information from the parents, teachers, and the assessors' own direct interactions with the child on the day of the assessment.|End of intervention is at a maximum of 15 weeks from baseline.|The analysis population are those with matched cases at 15 weeks.|||units on a scale||Standard Deviation|Mean
2664501|NCT01542502|Other Pre-specified|Ventilatory Efficiency (VE/VCO2 [Carbon Dioxide] Slope)|Interval change from baseline in ventilatory efficiency (VE/VCO2 slope) upon completion of 2 weeks treatment.|14 days|||||||
2664502|NCT01542502|Other Pre-specified|Inflammatory Biomarkers|Interval change from baseline in high-sensitivity C-reactive protein upon completion of 2 weeks treatment.|28 days|||||||
2664503|NCT01542502|Other Pre-specified|Adverse Events|Additional endpoints will include assessment of adverse events and hospitalizations during 4-week duration of study.|28 days|||||||
2664504|NCT01542502|Other Pre-specified|Heart Failure Symptoms (DASI)|Interval change from baseline in Heart Failure (HF) symptoms as measured by Duke Activity Status Index (DASI) upon completion of 2 weeks treatment.|28 days|||||||
2664505|NCT01542502|Other Pre-specified|Correlation Between Endpoints|Correlation between interval change in peak VO2 and high sensitivity C-reactive protein|28 days|||||||
2664506|NCT01542502|Secondary|Exercise Time|Interval change from baseline in duration of exercise during a standardized cardiopulmonary exercise test upon completion of 2 weeks treatment|14 days||||minutes||Inter-Quartile Range|Median
2664507|NCT01542502|Primary|Peak Oxygen Consumption (Peak VO2)|The primary endpoint is the change in peak oxygen consumption among stable heart failure patients (n = 12) following 14-days treatment with daily doses of Anakinra 100 mg (SC, subcutaneous).|14 days||||ml*kg^-1*min^-1||Inter-Quartile Range|Median
2664508|NCT01542398|Secondary|African Youth Psychosocial Assessment Inventory - Depression and Anxiety Subscales|Internalising symptoms were assessed using the African Youth Psychosocial Assessment Instrument (AYPA) (Betancourt et al., 2009).This 17 item Likert (0 = minimum, 51 = maximum) measure was developed in northern Uganda after extensive qualitative consultation with young people, caregivers and mental health workers. A high score on the AYPA indicates a high level of internalizing symptoms. It is the only African developed, validated questionnaire available, had been used in separate studies with war-affected children in the DR Congo (McMullen et al., 2013; O'Callaghan, McMullen, Shannon, Rafferty & Black; 2013) and includes symptoms of distress which do not appear in Western-developed measures (e.g. muttering to oneself, feeling pain in your heart, sitting with your head in your hand etc.). Test-retest reliability (carried out with a subset of 30 participants) for the AYPA was 0·91, inter-rater reliability was 0·58 (n = 26) and internal consistency was 0·787 (internalising symptoms).|pre-intervention, 3 weeks later||||units on a scale||Standard Deviation|Mean
2664562|NCT01541865|Secondary|Reduction in Estimated Glomerular Filtration Rate (eGFR) >25%||2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 25 participants were not evaluable.|||participants|||Number
2664509|NCT01542398|Primary|Reduction in Post-traumatic Stress Reaction Symptoms Among Participants|To assess post-traumatic stress reaction symptoms the 8-item Impact of Events Scale (CRIES-8) was used (Yule, 1997). Respondents indicating how frequently they experience a symptom on a 4-point Likert scale (0, 1, 2, 3). Thus the minimum score was 0 while the maximum score was 24. A high score indicates a high level of post-traumatic stress symptoms. This 8-item CRIES, which was designed for children over 7 years of age, has an identical factor structure to the 22-item version (Yule, 1997) which was previously validated with a sample of 1,046 war-affected adolescents in the eastern Democratic Republic of Congo (Mels, Derluyn, Broekaert & Rosseel, 2010) (internal reliability range: 0·79 to 0·84; Cronbach's alpha for the total scale: 0·93). In the current study, internal consistency was 0·557.|1-week before intervention, 3-weeks later||||units on a scale||Standard Deviation|Mean
2664510|NCT01542372|Secondary|Change in the SF-12 at 12 Weeks in Step II|A measure of severity of self-perceived functioning. Total score ranges from 0 to 100, with a higher score indicating better self-perceived functioning. Change scores were calculated.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2664511|NCT01542372|Secondary|Change in the Cambodian Culturally Sensitive Complaint Profile at 12 Weeks in Step II|A measure of somatic symptoms and cultural syndromes commonly found among distressed Cambodian refugees. Each item is rated on a 0-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 0 and a maximum of 4. Change scores were calculated.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2664512|NCT01542372|Secondary|Change in the SCL Anger Severity at 12 Weeks in Step II|A measure of anger severity, which is the SCL Anger Scale. Each item is rated on a 0-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 0 and a maximum of 4. Change scores were calculated.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2664513|NCT01542372|Secondary|Change in the HSCL Depression Scale at 12 Weeks in Step II|A measure of depression severity, which is the HSCL Depression Scale. Each item is rated on a 1-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 1 and a maximum of 4. Change scores were calculated.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2664514|NCT01542372|Secondary|Change in the HSCL Anxiety Scale at 12 Weeks in Step II|A measure of anxiety severity, which is the HSCL Anxiety Scale. Each item is rated on a 1-4 Likert-type scale, with a higher score indicating worse psychopathology. Mean scale scores were used, giving a minimum of 1 and a maximum of 4. Change scores were calculated.|Baseline and 12 weeks||||units on a scale||Standard Deviation|Mean
2664515|NCT01542372|Primary|Change in the PTSD Checklist (PCL) at 12 Weeks in Step II|A measure of PTSD severity, which is the PTSD Checklist. Total score range is 17 to 85, with a higher score indicating greater psychopathology. Change scores were calculated.|Baseline and 12 weeks|Patients with PTSD checklist scores of 30 or above were eligible for Step II, which was medication augmentation or CBT augmentation.|||units on a scale||Standard Deviation|Mean
2664516|NCT01542307|Other Pre-specified|Post-gas Therapy Medication Use|The percentage of migraine attacks requiring the use of one or more anti-migraine medications after the period of gas inhalation, was selected as a secondary outcome measure.|60 minutes||||percentage of attacks|Migraine attacks||Number
2664517|NCT01542307|Secondary|Final Nausea Score 0-1 on the Visual Analog Scale (VAS)|"The percentage of migraine attacks with the final (60 minute) VAS nausea score 0-1 was selected as a secondary outcome measure.~The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|60 minutes||||percentage of attacks|Migraine attacks||Number
2664518|NCT01542307|Secondary|Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS)|"The percentage of migraine attacks with the final (60 minute) VAS visual symptom score 0-1 was selected as a secondary outcome measure.~The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|60 minutes||||percentage of attacks|Migraine attacks||Number
2664519|NCT01542307|Secondary|Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS)|"The percentage of migraine attacks with the final (60 minute) VAS pain score either 0-1, or a 3-point improvement from baseline, was selected as a secondary outcome measure.~The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|60 minutes||||percentage of attacks|Migraine attacks||Number
2664520|NCT01542307|Secondary|Final Pain Severity Score 0-1 on the Visual Analogue Scale (VAS)|"The percentage of migraine attacks with the final (60 minute) VAS pain score 0-1 was selected as a secondary outcome measure.~The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|60 minutes||||percentage of attacks|Migraine attacks||Number
2664521|NCT01542307|Secondary|Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS)|"The mean change in VAS pain scores from 0 minutes to 60 minutes was selected as a secondary outcome measure.~The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|Baseline (0 minutes) to 60 minutes||||units on a scale|Migraine attacks|Standard Deviation|Mean
2664522|NCT01542307|Secondary|Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS)|"The mean change in VAS pain scores from 0 minutes to 15 minutes was selected as a secondary outcome measure.~The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|Baseline (0 minutes) to 15 minutes||||units on a scale|Migraine attacks|Standard Deviation|Mean
2664523|NCT01542307|Primary|Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS)|"The mean change in VAS pain scores from 0 minutes to 30 minutes was selected as the primary outcome measure.~The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms."|From baseline (0 minutes) to 30 mins|Number of migraine attacks treated with Oxygen or Medical Air|||units on a scale|Migraine attacks|Standard Deviation|Mean
2664524|NCT01542255|Secondary|Clinical Response Rate|To be assigned a status of partial response or complete response, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of stable disease, follow-up measurements must have met the stable disease criteria at least once after study entry at a minimum interval (in general, not less than 6-8 weeks) that is defined in the study protocol|Tumor evaluation will be performed every 8 weeks from day1 of cycle 1 (+ 1 week) while on therapy, clinical response will be assessed no less than 4 weeks after response criteria met.||||Participants|||Count of Participants
2664526|NCT01542229|Post-Hoc|Young Mania Scale|The Young Mania Rating Scale (YMRS) is a commonly used measure to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition. Additional information is based upon clinical observations made during the course of the clinical interview. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Scores range from 0 to 60 and are summed with higher scores reflective of higher symptom severity.|pre to post treatment (12 weeks)|A subset of participants were administered the HAM-D as an exploratory analysis.|||units on a scale||Standard Error|Mean
2664527|NCT01542229|Post-Hoc|The Difficulties in Emotion Regulation Scale|"The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report questionnaire designed to assess multiple aspects of emotion dysregulation. It yields a total score as well as 6 scale scores: Non-acceptance of emotional responses; Difficulties engaging in goal directed behavior; Impulse control difficulties; Lack of emotional awareness; Limited access to emotion regulation strategies; and Lack of emotional clarity. Item scores range from 1 almost never to 5 almost always with total summed scores ranging from 36 to 180, and higher scores reflective of greater emotion regulation difficulties."|baseline|The DERS was added at a later time as an exploratory variable.|||score on a scale||Standard Deviation|Mean
2664528|NCT01542229|Post-Hoc|Psychotic Symptom Rating Scales|The Psychotic Symptom Rating Scales (PSYRATS) is an instrument designed to quantify the severity of delusions and hallucinations. The measure has 17 items scored from 0 to 4 (11 items measure auditory hallucinations; 6 items measure delusions). Scores range from 0 to 68 and are summed with higher scores reflective of more severe psychosis.|pre to post treatment (12 weeks)|A subset of participants were administered the HAM-D as an exploratory analysis.|||score on a scale||Standard Error|Mean
2664529|NCT01542229|Post-Hoc|Hamilton Depression Scale|The Hamilton Depression Scale (HAM-D) is a 17, 21, or 24 item measure of depression severity. In the 17-item version, which was used, nine of the items are scored on a five-point scale, ranging from 0 to 4; and 8 of the items are scored on a 3-point scale, ranging from 0 to 2. Total scores on the HAM-D are summed and range from 0-53 with higher scores reflective of more severe depressive symptoms.|pre to post treatment (12 weeks)|A subset of participants were administered the HAM-D as an exploratory analysis.|||score on a scale||Standard Error|Mean
2664530|NCT01542229|Secondary|Pittsburgh Seep Quality Index|The Pittsburgh Sleep Quality Index (PSQI) is a 19-item commonly used and well validated self-report measure of sleep quality and disturbance. Scores on the PSQI range from 0 to 21, with ratings of 5 or higher indicative of poor sleep quality. Item 9, assessing overall quality of sleep, was used in current analyses. Scores on this item range from 0 to 3, with higher scores indicative of worse sleep quality.|pre to post treatment (12 weeks)|Variability in sample size for primary outcomes pre to post due to attrition (i.e., treatment dropout and/or lost to follow-up).|||score on a scale||Standard Error|Mean
2664531|NCT01542229|Secondary|Veterans SF 12 Health Survey (SF-12)|The Veterans SF 12 Health Survey (SF-12) is a valid and reliable instrument to measure quality of life and/or functional status in Veterans. The SF-12 was used to track changes in general mental [MCS mental component score) and physical health (PCS physical component score) functioning. Scores on the SF-12 scales range from 0 to 100 once converted and higher scores are indicative of better mental and physical health. The MCS score was used in the current analyses.|pre to post treatment (12 weeks)|Variability in sample size for primary outcomes pre to post due to attrition (i.e., treatment dropout and/or lost to follow-up).|||score on a scale||Standard Error|Mean
2664532|NCT01542229|Secondary|Brief Psychiatric Rating Scale-Extended (BPRS-E)|The Brief Psychiatric Rating Scale-Extended (BPRS-E) is a 24 item measure of psychopathology across several dimensions (i.e., delusions, motor hyperactivity, withdrawal and blunted affect, self-neglect, etc.) and is a commonly used measure for severely and persistently ill patient populations. Total BPRS scores were used and can range from 24 (score of 1 on all items, symptom not present) to 168 (score of 7 on all items, extremely severe).|pre to post treatment (12 weeks)|Variability in sample size for primary outcomes pre to post due to attrition (i.e., treatment dropout and/or lost to follow-up).|||score on a scale||Standard Error|Mean
2664533|NCT01542229|Secondary|Beck Depression Inventory-II (BDI-II)|The Beck Depression Inventory-II is a 21 item measure of depressive severity. Total BDI-II scores were used. Scores on the BDI-II range from 0 to 63 with higher scores indicative of greater symptom severity.|pre to post treatment (12 weeks)|Variability in sample size for primary outcomes pre to post due to attrition (i.e., treatment dropout and/or lost to follow-up).|||score on a scale||Standard Error|Mean
2664534|NCT01542229|Primary|Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)|The Clinician Administered PTSD (Posttraumatic Stress Disorder; PTSD) Scale (CAPS) is a 30-item structured interview that corresponds to DSM-IV criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assess symptoms over the past week/month. The CAPS was used to measure current PTSD (yes/no diagnosis) as well as total PTSD severity (scores range 0-136, with higher scores indicative of more severe PTSD).|pre to post treatment (12 weeks)|Variability in sample size for primary outcomes pre to post due to attrition (i.e., treatment dropout and/or lost to follow-up).|||score on a scale||Standard Error|Mean
2664535|NCT01542229|Primary|Posttraumatic Stress Disorder (PTSD) Checklist (PCL)|The PTSD Checklist (PCL) is a 17-item self-report measure of PTSD symptoms based on DSM-IV criteria. Total scores on the PCL were used, and total scores range from 17 to 85 with higher scores indicative of greater PTSD severity.|pre to post treatment (12 weeks)|Variability in sample size for primary outcomes pre to post due to attrition (i.e., treatment dropout and/or lost to follow-up).|||score on a scale||Standard Error|Mean
2664536|NCT01542125|Primary|Pain|"A horizontal 100 mm anchored Visual Analogue Scale (0 = no pain, 100 = worst possible pain) was used by the adult caregiver and the orthopedic technician to document the pain associated with Perc Pin removal for participant children.~The Oucher Scale was used to assess pain intensity in participant children and included two separate scales. 6 photographs were assigned scores of 0, 20, 40, 60, 80, and 100 (in increasing increments of pain), such that these would be the scores averaged for participants unable to count by number. Children able to count to 100 by ones or tens and who could identify the larger of 2 numbers used the second scale; a vertical numeric one (0-100) that was printed next to the faces."|Before the application of Liposomal Lidocaine and immediately after Pin Perc removal, approximately 30 minutes||||units on a scale||Standard Deviation|Mean
2664537|NCT01542034|Secondary|Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat population; missing values were imputed using a multiple imputation process.|||units on a scale||Standard Deviation|Mean
2664538|NCT01542034|Secondary|Percentage of Participants With a Magnetic Resonance Imaging (MRI) Response|An MRI responder is a participant who exhibited at least a 10% reduction in submental fat volume as measured by MRI from Baseline to 12 weeks after last treatment. Magnetic resonance imaging was evaluated in a subset of participants at selected centers.|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|The ITT-MRI population consisted of all randomized participants who participated in the MRI cohort and had evaluable Baseline MRI data. A multiple imputation process was used.|||percentage of participants|||Number
2664539|NCT01542034|Primary|Percentage of Participants Who Achieved a Composite 2-grade Response|"A composite 2-grade response is defined as at least a 2-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat population; missing values were imputed using a multiple imputation process.|||percentage of participants|||Number
2664540|NCT01542034|Primary|Percentage of Participants Who Achieved a Composite 1-grade Response|"A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) 12 weeks after the last treatment.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.~The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat."|Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)|Intent-to-treat (ITT) population; missing values were imputed using a multiple imputation process.|||percentage of participants|||Number
2664541|NCT01541969|Secondary|Tinnitus Handicap Questionnaire (THQ)|Change in the global score on a 27 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 10' and so a positive change score indicates a reduction of tinnitus symptoms.|Baseline (visit 2) and 36 weeks (visit 10)|We have analyzed both complete case and multiple imputed data for the mean change in global THQ score from baseline (visit 2) to 36 weeks (visit 10). Here we report complete case data.|||units on a scale||Standard Deviation|Mean
2664542|NCT01541969|Secondary|Percent Change From Baseline in Normalized Oscillatory Power in the Delta Brainwave Pattern as Measured by Electroencephalography (EEG)|"Non-invasive recording to measure rhythmic patterns of spontaneous brain activity at rest. An a priori hypothesis targeted normalized delta rhythm. Band powers were calculated as percent change in delta brainwave pattern relative to change in total (1-90 Hz) EEG band. Comparison made between 'visit 2' and 'visit 6'.~We used a Neuroscan system (SynAmps2 model 8050, Compumedics Neuroscan, Charlotte, NC, USA) and custom cap with 66 equidistant scalp electrodes (Easycap, GmbH, Germany). A central frontal electrode was used as ground and a nose-tip electrode as reference. Electrode impedances were maintained at 5 kΩ prior to recordings. Recording was done with an offline filter of 0.5 to 200 Hz pass-band and 1 kHz sampling rate. Recording was over a continuous 10-minute period. Participants were seated in a quiet, darkened soundproof booth and were instructed to relax, keep eyes open and fix gaze on a marker point."|Baseline (visit 2) and 12 weeks (visit 6)|The EEG assessment was offered only to the first 50 participants enrolled at the Nottingham site. We have analyzed only complete case data for the mean change in delta band power from baseline (visit 2) to 12 weeks (visit 6).|||Percent change||Standard Deviation|Mean
2664543|NCT01541969|Secondary|World Health Organization Quality of Life Questionnaire (WHOQOL-BREF)|The WHOQOL-BREF is a 26-item, multi-attribute questionnaire measure of health related quality of life. Outcome was measured as a change on Question 1: 'How would you rate your quality of life (over the past 4 weeks)?' There are 5 response options (Very poor=1; Poor=2; Neither poor nor good=3; Good=4; Very good=5). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction in self-perceived quality of life.|Baseline (visit 2) and 12 weeks (visit 6)|We have analyzed both complete case and multiple imputed data for the mean change in Q1 score from baseline (visit 2) to 12 weeks (visit 6). Here we report complete case data.|||units on a scale||Standard Deviation|Mean
2664544|NCT01541969|Secondary|Tinnitus Functional Index (TFI)|Change in the global score on a 25 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction of tinnitus symptoms.|Baseline (visit 2) and 12 weeks (visit 6)|We have analyzed both complete case and multiple imputed data for the mean change in global TFI score from baseline (visit 2) to 12 weeks (visit 6). Here we report complete case data.|||units on a scale||Standard Deviation|Mean
2664545|NCT01541969|Secondary|Tinnitus Handicap Inventory (THI)|Change in the global score on a 25 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction of tinnitus symptoms.|Baseline (visit 2) and 12 weeks (visit 6)|We have analyzed both complete case and multiple imputed data for the mean change in global THI score from baseline (visit 2) to 12 weeks (visit 6). Here we report complete case data.|||units on a scale||Standard Deviation|Mean
2664546|NCT01541969|Primary|Tinnitus Handicap Questionnaire (THQ)|Change in the global score on a 27 item, multi-attribute questionnaire measure of the functional impact of tinnitus (0-100 scale). Change was computed as 'visit 2' - 'visit 6' and so a positive change score indicates a reduction of tinnitus symptoms.|Baseline (visit 2) and 12 weeks (visit 6)|We have analyzed both complete case and multiple imputed data for the mean change in global THQ score from baseline (visit 2) to 12 weeks (visit 6). Here we report complete case data.|||units on a scale||Standard Deviation|Mean
2664547|NCT01541930|Secondary|Pain (Visual Analogue Scale)|The pain linked to the fungating tumour over the last 24 hours was evaluated by the patient. The pain was graded using a 100 mm linear visual analogical scale (graded from 0 mm = no pain to 100 mm = severe pain).|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.|||mm||Standard Deviation|Mean
2664548|NCT01541930|Secondary|Appearance (Volume and Nature of Discharge at Cutaneous Ulcer)|Appearance score was evaluated by the Study Investigator using the following scale; 0: None (No discharge, e.g. frequency of dressing change: once daily), 1: Mild (Dressing need to be Changed twice daily), 2: Moderate (Dressing need to be Changed 3 times daily), 3: Marked (Dressing need to be Changed >3 times daily / Bloody).|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.|||participants|||Number
2664549|NCT01541930|Secondary|Smell Score by Patient|Tumour smell score was evaluated by the Patient using the following scale; 0: No smell, 1: Smell present but not offensive, 2: Mildly offensive smell,3: Moderately offensive smell, 4: Extremely offensive smell|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.|||participants|||Number
2664550|NCT01541930|Secondary|Smell Score by Nurse|Tumour smell score was evaluated by the Nurse using the following scale; 0: No smell, 1: Smell present but not offensive, 2: Mildly offensive smell,3: Moderately offensive smell, 4: Extremely offensive smell|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.|||participants|||Number
2664551|NCT01541930|Secondary|Smell Score by Investigator|Tumour smell score was evaluated by the Study Investigator using the following scale; 0: No smell, 1: Smell present but not offensive, 2: Mildly offensive smell, 3: Moderately offensive smell, 4: Extremely offensive smell|on Days 0 (baseline), 7, and 14|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.|||participants|||Number
2664552|NCT01541930|Primary|The Success Rate|The success rate, where success for a patient is defined as a smell score of 0 or 1 (0: No smell, 1: Smell present but not offensive) as assessed by the Study Investigator|at Day 14 (end of treatment)|All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses. Only observed cases were part of the analyses. If the primary endpoint was missing, an additional analysis of this endpoint was performed using the last observation carried forward (LOCF) to impute the missing data.|||percentage of participants||90% Confidence Interval|Number
2664553|NCT01541917|Secondary|Change in Approach Coping|"Scores on the Approach Coping sub-scale of the Pain Coping Questionnaire were used to measure approach coping, which is a type of coping considered to be adaptive and helpful for pain. Responses to items on this subscale are on a 5-point scale (never use to very often use) and are averaged together for the subscale score, such that scores range from a worst possible value of 1 to a best possible value of 5."|Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up||||units on a scale||Standard Deviation|Mean
2664554|NCT01541917|Secondary|Change in Children's Arthritis Self-Efficacy (CASE) Scores|"Confidence in managing arthritis was measured by patient self-report using an electronic version of the Children's Arthritis Self-Efficacy (CASE) scale. Responses on a 5-point scale (not at all sure to very sure) are averaged together to form a total score, with 0 being the worst possible value and 5 being the best possible value."|Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up||||units on a scale||Standard Deviation|Mean
2664555|NCT01541917|Secondary|Change in Disease Activity|Disease activity was assessed by the treating physician based on a complete joint count (count of the number of joints that are swollen, painful, tender, or restriction in motion). The lowest (best) value is 0, and the highest (worst) possible value is 300.|Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up||||joints||Standard Deviation|Mean
2664556|NCT01541917|Secondary|Change in Medical Issues, Exercise, Pain and Social Support Questionnaire (MEPS) Education Score|Knowledge about Juvenile Idiopathic Arthritis was measured by patient self-report using an electronic version of the Medical Issues, Exercise, Pain and Social support (MEPS) Questionnaire. Responses on this scale are measured on a 0-10 numeric rating scale and averaged together to form a summary score, with 0 being the worst possible score and 10 being the best possible score.|Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up||||units on a scale||Standard Deviation|Mean
2664557|NCT01541917|Primary|Change in PedsQL Rheumatology Health-Related Quality of Life Total Score|Health-related quality of life was measured by patient self-report using an electronic version of the PedsQL Rheumatology Module. Responses on this scale are transformed into a 0-100 scale, with 0 being the worst value for health-related quality of life and 100 being the best possible value for health-related quality of life.|Pre-intervention, post-intervention, 6-month follow-up, 12-month follow-up||||units on a scale||Standard Deviation|Mean
2664558|NCT01541917|Primary|Change in Pain Intensity|"Pain intensity was assessed by patient-self report using an electronic numeric rating scale ranging from 0-10, with 0 being the lowest value (no pain) and 10 being the highest value (very much pain)."|Baseline, post-treatment, 6-month follow-up, 12-month follow-up|All randomized patients were analyzed regardless of whether or not they completed treatment (intent to treat analyses).|||Units on a scale||Standard Deviation|Mean
2664559|NCT01541891|Other Pre-specified|Evaluation of Visual Acuity|The LogMAR scale evaluates the visual acuity of subjects with a logarithmic scale where base 0 is the best visual acuity and 1 is the worst. This variable will be reported with means for comparison between groups.|60 days||||units on LogMAR scale||Standard Deviation|Mean
2664560|NCT01541891|Secondary|Presence of Adverse Events|The presence of adverse events will be reported in both treatment arms. This variable will be reported by the number of events presented.|60 days||||number of cases|||Number
2664563|NCT01541865|Secondary|Hypertensive Emergency Necessitating Hospital Admission (Unrelated to Medication and/or Non-compliance)||2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.|||participants|||Number
2664564|NCT01541865|Secondary|Chronic Symptomatic Orthostatic Hypotension||2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.|||participants|||Number
2664565|NCT01541865|Secondary|Angiographically-documented Renal Stenosis Requiring an Intervention||2 Years|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.|||participants|||Number
2664566|NCT01541865|Secondary|Sudden Cardiac Death at Time of Procedure||Duration of the procedure (average of 65 minutes)||||participants|||Number
2664567|NCT01541865|Secondary|Myocardial Infarction at Time of Procedure||Duration of the procedure (average of 65 minutes)||||participants|||Number
2664568|NCT01541865|Secondary|Cerebrovascular Accident (CVA) at Time of Procedure||Duration of the procedure (average of 65 minutes)||||participants|||Number
2664569|NCT01541865|Secondary|Renal Artery Infarction or Embolus||Duration of the procedure (average of 65 minutes)||||participants|||Number
2664570|NCT01541865|Secondary|Renal Artery Dissection or Perforation During the Procedure That Requires Stenting or Surgery||Duration of the procedure (average of 65 minutes)||||participants|||Number
2664571|NCT01541865|Primary|Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by 24-hour Ambulatory Blood Pressure|Change in systolic and diastolic blood pressure at six (6) months as measured by 24-hour ambulatory blood pressure monitoring (ABPM) following therapeutic renal denervation compared to baseline using a validated ABPM device.|Baseline and 6 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 76 participants were not evaluable at either the baseline or 6 month assessment.|||mm Hg||Standard Deviation|Mean
2664572|NCT01541865|Secondary|Absence of Flow Limiting Stenosis in the Renal Artery|Absence of flow limiting stenosis in the renal artery at six (6) months follow up time point as measured by renal duplex ultrasound|6 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 3 participants were not evaluable.|||participants w/o flow limiting stenosis|||Number
2664573|NCT01541865|Primary|Change in Systolic and Diastolic Blood Pressure at Six (6) Months as Measured by Office-based Blood Pressure Assessment|Change in systolic and diastolic blood pressure at six (6) months as measured by office-based blood pressure assessment following therapeutic renal denervation compared to baseline. Office blood pressure will be measured using a validated electronic device according to a standardized procedure. .|Baseline and 6 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 3 participants were not evaluable.|||mm Hg||Standard Deviation|Mean
2664574|NCT01541826|Secondary|Energy-adjusted Vitamin A Intake|Energy-adjusted vitamin A intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|"Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose."|||retinol equivalent mcg/day||Standard Error|Mean
2664575|NCT01541826|Secondary|Intake of Dietary Antioxidant Capacity|Energy-adjusted intake of dietary antioxidant capacity determined by 3-day dietary recalls at baseline and 12 weeks. Values reported as average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|"Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose."|||Vitamin C equivalents||Standard Error|Mean
2664576|NCT01541826|Secondary|Polyphenol Intake|Energy-adjusted polyphenol intake assessed by 3-day dietary recalls at baseline and 12 weeks, values determined by average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|"Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose."|||mg/day||Standard Error|Mean
2664577|NCT01541826|Secondary|Energy-adjusted Micronutrient Intake|Energy-adjusted micronutrient intake from 3-day dietary recalls at baseline and 12 weeks. Values reported as the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|"Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose."|||mg/day||Standard Error|Mean
2664578|NCT01541826|Secondary|Energy Intake|Energy intake reported from 3-day dietary recalls at baseline and 12 weeks, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|"Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose."|||kcal/d||Standard Error|Mean
2664579|NCT01541826|Secondary|Energy-adjusted Nutrient Intake: Carbohydrate, Protein, Fat, Fiber|Energy-adjusted intake based on 3-day dietary recalls, determined by the average of baseline and 12 weeks. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|"Survey data were not available for two participants in the Color-matched rice powder pill group. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose."|||g/day||Standard Error|Mean
2664580|NCT01541826|Secondary|Urinary Polyphenol Excretion|Overnight urinary polyphenol excretion after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||mg/mg creatinine||Inter-Quartile Range|Median
2664581|NCT01541826|Secondary|Superoxide Dismutase Activity|Fasting plasma superoxide dismutase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||units/mL||Standard Error|Mean
2664582|NCT01541826|Secondary|Glutathione Peroxidase Activity|Fasting plasma glutathione peroxidase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||nmol/min/mL||Standard Error|Mean
2664583|NCT01541826|Secondary|Catalase Activity|Catalase activity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||nmol/min/mL||Standard Error|Mean
2664584|NCT01541826|Secondary|Total Antioxidant Capacity|Fasting plasma total antioxidant capacity after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||micrograms vitamin C equivalents/mL||Standard Error|Mean
2664585|NCT01541826|Secondary|P-selectin|Fasting plasma P-selectin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||ng/mL||Standard Error|Mean
2664586|NCT01541826|Secondary|Soluble Vascular Cell Adhesion Molecule 1|Fasting plasma soluble vascular cell adhesion molecule 1 after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||ng/mL||Standard Deviation|Mean
2664587|NCT01541826|Secondary|Intercellular Adhesion Molecule 1|Fasting plasma intercellular adhesion molecule 1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||ng/mL||Standard Error|Mean
2664588|NCT01541826|Secondary|C-reactive Protein|Fasting plasma C-reactive protein after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||pg/mL||Standard Error|Mean
2664589|NCT01541826|Secondary|Tumor Necrosis Factor-alpha|Fasting plasma Tumor necrosis factor-alpha after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||pg/mL||Standard Error|Mean
2664590|NCT01541826|Secondary|Monocyte Chemoattractant Protein-1|Fasting plasma monocyte chemoattractant protein-1 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||pg/mL||Standard Error|Mean
2664591|NCT01541826|Secondary|Interleukin-6|Fasting plasma interleukin-6 after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||pg/mL||Standard Error|Mean
2664592|NCT01541826|Secondary|Interleukin-1 Beta|Fasting plasma interleukin-1 beta after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||pg/mL||Standard Error|Mean
2664593|NCT01541826|Secondary|Adiponectin|Fasting plasma adiponectin after chronic consumption. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||micrograms/mL||Standard Error|Mean
2664594|NCT01541826|Secondary|Urinary Excretion of Polyphenols|Urinary excretion of polyphenols, from 0 to 24 h after consumption of extract, area under the curve (AUC) in Chokeberry Extract Capsule (acute) arm only.|0 to 24 h after consumption of extract|Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule) as this analysis required additional collection time-points that were not utilized in the other arms.|||mg x h/mg creatinine||Standard Error|Mean
2664595|NCT01541826|Secondary|Plasma Area Under the Curve of Chokeberry Polyphenols and Their Metabolites.|Plasma area under the curve of chokeberry polyphenols and their metabolites. Measurement (time 0) began at study baseline. Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule).|0, 0.5, 1, 2, 4, 6, 9, 12, and 24 hours following dose|Not determined in chronic arms (Color-matched Rice Powder Pill or Chokeberry Extract Capsule) as this analysis required additional collection time-points that were not utilized in the other arms.|||micrograms x h/mL||Standard Error|Mean
2664596|NCT01541826|Secondary|LDL Receptor (LDLR) Protein|Monocyte LDL receptor protein by Western blot, normalized to β-actin after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||relative expression (LDLR/β-actin)||Standard Error|Mean
2664597|NCT01541826|Secondary|LDL Receptor (LDLR)|Monocyte LDL receptor mRNA normalized to glyceraldehyde-3-phosphate dehydrogenase after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Change from baseline at 12 weeks|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||relative expression (LDLR/GAPDH)||Standard Error|Mean
2664598|NCT01541826|Secondary|3-hydroxy-3-methyl-glutaryl Coenzyme A Reductase (HMGR)|Monocyte messenger ribonucleic acid (mRNA) expression normalized to glyceraldehyde-3-phosphate dehydrogenase (GAPDH) after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 12 wk|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||relative expression (HMGR/GAPDH)||Standard Error|Mean
2664599|NCT01541826|Secondary|Urinary F2-isoprostanes|Change in resting urinary F2-isoprostanes after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline and 12 weeks following intervention|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||ng/mmol creatinine||Standard Error|Mean
2664600|NCT01541826|Secondary|Resting Diastolic Blood Pressure|Change in resting diastolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, and 12 weeks following intervention|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||mmHg||Standard Error|Mean
2664601|NCT01541826|Secondary|Resting Systolic Blood Pressure|Change in resting systolic blood pressure after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, and 12 weeks following intervention|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||mmHg||Standard Error|Mean
2664602|NCT01541826|Secondary|Triglycerides|Change in fasting plasma triglycerides from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|6 and 12 weeks after supplementation|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||mg/dL||Standard Error|Mean
2664603|NCT01541826|Secondary|HDL-cholesterol|Change in fasting plasma cholesterol from baseline after chronic supplemenation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|6 and 12 weeks after supplementation|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||mg/dL||Standard Error|Mean
2664604|NCT01541826|Secondary|Total Cholesterol|Change in fasting total cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|6 and 12 weeks after supplementation|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||mg/dL||Standard Error|Mean
2664605|NCT01541826|Primary|LDL Cholesterol|Change in LDL cholesterol from baseline after chronic supplementation. Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|Baseline, 6 weeks, 12 weeks of intervention|Not determined in Chokeberry Extract Capsule (Acute) arm as this arm was a one-time dose.|||mg/dL||Standard Error|Mean
2664606|NCT01541735|Primary|Total Insulin Secretion|The hyperglycemic-hyperinsulinemic clamp technique is performed to assess the total insulin secretion|Change from baseline of total insulin secretion at 45 day (plus or minus 3 days)||||µU/ml||Standard Deviation|Mean
2664607|NCT01541735|Primary|Second Phase of Insulin Secretion|Change from baseline in first phase insulin secretion at 45 day. (plus or minus 3 days)|Baseline and 45 day||||µU/ml||Standard Deviation|Mean
2664608|NCT01541735|Secondary|Glycated Hemoglobin A1C||Change from Baseline in glycated hemoglobin A1C at 45 day.||||percentage||Standard Deviation|Mean
2664609|NCT01541735|Primary|First Phase of Insulin Secretion|The hyperglycemic-hyperinsulinemic clamp technique is perform to assess the phases of insulin secretion: first, late and total insulin secretion.|Change from Baseline at 45 days. (plus or minus 3 days)|The analysis was determined per protocol and sample size was calculated whit the formula for clinical trial|||µU/ml||Standard Deviation|Mean
2664610|NCT01541644|Primary|To Determine the Response Rate (Via FACT/GOG-Ntx Scores) Effectiveness and Safety of Acupuncture in Alleviating Neuropathic Symptoms When Treating Patients With Moderate to Severe Bortezomib-induced Peripheral Neuropathy (BIPN)|The Neuropathic Pain Scale (NPS) uses self-report visual analogue scales (VAS) to quantify on a scale of 0-10 (with total NPS score of 1-100), global pain intensity and unpleasantness and 8 other descriptive qualities of neuropathic pain. Response defined as average change of Clinical Total Neuropathy Score (TNSc) greater than or equal to 10% over 10 weeks compared to baseline. Effect defined as as average change of Functional Assessment of Cancer Therapy-Neurotoxicity/ Gynecologic Oncology Group (FACT/GOG-Ntx)over 10 weeks as compared to baseline. Safety will be assessed by recording side effects from acupuncture treatment. Please note TNSc results deemed invalid as original validation of TNSc was performed by 2 neuromuscular trained physicians & the TNSc in our trial was performed by a research nurse. The reliability & validity of research nurse's TNSc not established pre-trial. For the scale range, the higher the score the worse the symptoms and function. No subscales were used.|Baseline and 10 weeks||||units on a scale (1 - 100)||Standard Deviation|Mean
2664611|NCT01541553|Secondary|Partial Clearance of AKs at Week 11|Partial clearance of AKs at Week 11, defined as 75% or greater reduction from baseline in the number of clinically visible AKs in the selected treatment area at Week 11|Week 11||||participants|||Number
2664612|NCT01541553|Secondary|Percentage Change From Baseline in Number of AKs at Week 11|Percentage change from baseline in number of AKs at Week 11|Baseline to week 11||||percentage of change||Standard Deviation|Mean
2664613|NCT01541553|Primary|Complete Clearance of AKs at Week 11|To determine the 11-week rate of complete clearance of AKs (defined as no clinically visible AKs) in the selected treatment area using sequential cryotherapy and field treatment with PEP005 Gel compared to cryotherapy alone.|11 weeks||||participants|||Number
2664614|NCT01541397|Secondary|Plasma Phenylalanine Levels|Plasma phenylalanine levels will be monitored to determine effectiveness of Kuvan therapy.|weekly for 6 weeks, then at least every three months up to 1 year|Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants).||||||
2664615|NCT01541397|Secondary|Diet Analysis|Subjects will provide a 3 day diet record for every plasma amino acid evaluation. Diets will be analyzed to determine phenylalanine, protein, calories, fat, vitamins and minerals.|every 3 months up to 1 year|Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants).||||||
2664616|NCT01541397|Secondary|Plasma Amino Acid Profile|Evaluation of levels of plasma amino acids.|every three months up to 1 year|Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants).||||||
2664617|NCT01541397|Primary|Bone Mineral Density|A DXA scan will be conducted one year after Kuvan therapy is initiated.|1 year after initiation of Kuvan therapy|Zero participants were analyzed because the study was ended early (due to an insufficient number of enrolled participants).||||||
2667071|NCT01519518|Primary|Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization||28 days||||percentage of total participants|||Number
2664618|NCT01541384|Primary|Immunosuppression (Tacrolimus) Adherence|"The primary outcome will be the percentage of tacrolimus doses taken as directed during the final 90 days of this 180 day trial as measured by the GlowCap. This includes a 14 day wash-in period for device acclimatization."|90 days||||percentage of correct tacrolimus doses||Standard Deviation|Mean
2664619|NCT01541371|Secondary|Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Week 12|The self-administered sleep VAS scale (0-100 milimeter [mm]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time).|Baseline and Week 12|"FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here N (Number of Participants Analyzed): number of participants who were evaluable for this measure. ‘n’: number of participants who were evaluable at given time point for each arm group, respectively."|||mm||Standard Deviation|Mean
2664620|NCT01541371|Secondary|Number of Participants With Satisfaction With the Study Treatment|Participants assessed their satisfaction with paliperidone ER on a 5-point scale: 1 (very good), 2 (good), 3 (moderate), 4 (poor) and 5 (very poor).|Baseline and Week 12|"FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here N (Number of Participants Analyzed): number of participants who were evaluable for this measure. ‘n’: number of participants who were evaluable at given time point for each arm group, respectively."|||Participants|||Number
2664621|NCT01541371|Secondary|Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12|PSP assesses the degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =<30, functioning so poorly as to require intensive supervision.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here ‘n’: number of participants who were evaluable at given time point for each arm group, respectively.|||Units on a scale||Standard Deviation|Mean
2664622|NCT01541371|Secondary|Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 12|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to normal, not at all ill and a rating of 7 is equivalent to among the most extremely ill participants. Higher change scores indicate worsening."|Baseline and Week 12|"FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement. Here N (Number of Participants Analyzed): number of participants who were evaluable for this measure. ‘n’: number of participants who were evaluable at given time point for each arm group, respectively."|||units on a scale||Standard Deviation|Mean
2664623|NCT01541371|Secondary|Percentage of Participants With Response to Positive and Negative Syndrome Scale (PANSS) Total Score|PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Percentage of participants with at least 20 percent improvement of PANSS total score was measured.|Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.|||Percentage of participants||95% Confidence Interval|Number
2664624|NCT01541371|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 12|The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28. Higher change score indicates greater severity.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.|||Units on a scale||Standard Deviation|Mean
2664625|NCT01541371|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 12|PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Positive syndrome subscale ranges from 7 to 49, higher change scores indicate worsening. Negative syndrome subscale ranges from 7 to 49, higher change scores indicate worsening. General Psychopathology subscale ranges from 16 to112, higher change scores indicate worsening.|Baseline and Week 12|FAS included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.|||Units on a scale||Standard Deviation|Mean
2664626|NCT01541371|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12|PANSS is a medical scale that assesses various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions [a false belief held in the face of strong differing evidence, especially as a symptom of psychiatric disorder] and hallucinations [imagining things], and withdrawal into the self). The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).|Baseline and Week 12|Full analysis set (FAS) included all participants who received at least 1 dose of study medication and had at least 1 post baseline efficacy measurement.|||unit on a scale||Standard Deviation|Mean
2664665|NCT01541215|Secondary|Ratio to Baseline: Free Fatty Acids|Ratio to baseline (free fatty acids) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664627|NCT01541358|Secondary|Sensitivity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy|"Sensitivity is the ability of a test to correctly identify those with the disease (true positive rate). This study determined how many lesions were detected by F18 NaF PET/CT compared to the known results. The calculation for sensitivity is TP / (TP+FN), where:~TP = true positive (the lesion was accurately detected on both F18 NaF and comparison study) FN = false negative (the lesion was not detected on the PET/CT but was detected on the comparison study)~The result is expressed as the percentage of confirmed lesions across all participants that were also detected by F18 NaF PET/CT."|an estimated average of 2 hours|Both participants were included in the analysis.|||percentage of sensitivity|||Number
2664628|NCT01541358|Secondary|Specificity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy|"Specificity is the ability of a test to correctly determine the absence of disease (true negative). This study determined how accurately F18 NaF PET/CT performed at detecting the absence of disease.~The calculation for specificity is TN / (TN + FP), where:~TN = the participant was a true negative (the lesion was not detected on F18 NaF PET/CT and the patient does not have the disease) FP = the participant was a false positive (the lesion was falsely detected on the F18 NaF PET/CT and the patient does not have the disease) The result is expressed as a percentage."|an estimated average of 2 hours|Both participants were included in the analysis.|||percentage of specificity|||Number
2664629|NCT01541358|Primary|Total Number of Lesions Identified by F-18 NaF PET/CT in Patients With Suspected Skeletal Malignancy|F-18 NaF is a positron emission tomography (PET) bone imaging agent that targets changes in the bone. The fluoride ions are taken up in areas of the bone that have increased bone remodeling (bone repair) and increased blood flow, which is indicative of diseases such as cancer.|an estimated average of 2 hours|Includes all study participants.|||lesions detected by F18 NaF|||Number
2664630|NCT01541254|Secondary|Unplanned Embolization Coiling Within 6 Months|If the target lesion(aneurysm)treated needed further embolization within 6 months of initial treatment(detected during follow up or unscheduled visit ),data will be recorded and analyzed.|Day 1-6 months|||||||
2664631|NCT01541254|Secondary|Device and Procedure Related Serious Adverse Events|All Serious Adverse events will be reported per protocol|Day 1-6months(± 4 months)|||||||
2664632|NCT01541254|Secondary|Stent Migration at 6 Months|Angiographic images will be comparing post procedure sent position to 6 months|6 months|||||||
2664633|NCT01541254|Secondary|Significant Stenosis(>50%) of the Treated Artery at 6 Months|Parent Artery will be measured baseline and compared at 6 months post procedure per review by the Independent Core Lab.|6 months|||||||
2664634|NCT01541254|Secondary|Successful Delivery of the LVIS™ Device Measures by Technical Success|Technical success being defined as: access to the lesion, successful deployment of the LVIS™ device.|24 hours|||||||
2664635|NCT01541254|Secondary|Parent Artery Patency Measured Angiographically at 6 Months|To be assessed by Independent Core Lab.|6 months|||||||
2664636|NCT01541254|Primary|Safety Measures as Any Major Stroke or Death Within 30 Days, or Major Ipsi-lateral Stroke or Neurological Death Within 6 Months|A major stroke is defined as a new neurological event that persists for >24 hours and results in a ≥ 4 point increase in the National Institutes of Health Stroke Scale (NIHSS) score compared to baseline or compared to any subsequent lower score.|30 days-6 months||||patients|||Number
2664637|NCT01541254|Primary|Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 6 Months (± 4 Weeks)|Imaging from each subject to be reviewed by an independent core lab who will be comparing with baseline and post procedure images.|6 months ± 4 weeks||||percent occlusion of aneurysm||Standard Deviation|Mean
2664638|NCT01541215|Secondary|Change in Bone Age Assessment (X-ray of Left Hand and Wrist)||Week 0, week 156 (2 year follow-up)||2021-05-31|05/2021||||
2664639|NCT01541215|Secondary|Change in Bone Age Assessment (X-ray of Left Hand and Wrist)||Week 0, week 104 (1 year follow-up)||2020-05-31|05/2020||||
2664640|NCT01541215|Secondary|Change in Pubertal Assessment/Progression (Tanner Staging)||Week 0, week 156 (2 year follow-up)||2021-05-31|05/2021||||
2664641|NCT01541215|Secondary|Change in Pubertal Progression/Progression (Tanner Staging)||Week 0, week 104 (1 year follow-up)||2020-05-31|05/2020||||
2664642|NCT01541215|Secondary|Growth (Height) Velocity in cm/Year (if Subject is Still Growing)||Week 156 (2 year follow-up)||2021-05-31|05/2021||||
2664643|NCT01541215|Secondary|Growth (Height) Velocity in cm/Year (if Subject is Still Growing)||Week 104 (1 year follow-up)||2020-05-31|05/2020||||
2664644|NCT01541215|Secondary|Number of Serious Adverse Events||0-156 weeks||2021-05-31|05/2021||||
2664645|NCT01541215|Secondary|Number of Serious Adverse Events||0-104 weeks||2020-05-31|05/2020||||
2664646|NCT01541215|Secondary|Number of Adverse Events||0-156 weeks||2021-05-31|05/2021||||
2664647|NCT01541215|Secondary|Number of Adverse Events||0-104 weeks||2020-05-31|05/2020||||
2664648|NCT01541215|Secondary|Number of Serious Adverse Events|Total number of serious adverse events during entire treatment period.|0-52 weeks|Safety analysis set|||events|||Number
2664649|NCT01541215|Secondary|Number of Serious Adverse Events|Total number of serious adverse events during 26 weeks.|0-26 weeks|Safety analysis set|||events|||Number
2664650|NCT01541215|Secondary|Number of Adverse Events|Total number of adverse events during entire treatment period.|0-52 weeks|Safety analysis set|||events|||Number
2664651|NCT01541215|Secondary|Number of Adverse Events|Total number of adverse events during 26 weeks.|0-26 weeks|Safety analysis set|||events|||Number
2664652|NCT01541215|Secondary|Number of Hypoglycaemic Episodes|Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 52.|0-52 weeks|Safety analysis set|||hypoglycaemic episodes|||Number
2664653|NCT01541215|Secondary|Number of Hypoglycaemic Episodes|Total number of hypoglycaemic episodes according to American Diabetes Association (ADA) classification from baseline (week 0) to week 26.|0-26 weeks|Safety analysis set|||hypoglycaemic episodes|||Number
2664666|NCT01541215|Secondary|Ratio to Baseline: Triglycerides|Ratio to baseline (triglycerides) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664654|NCT01541215|Secondary|Height Velocity SDS|Height velocity SDS scores at week 52. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below −3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Safety analysis set. Number of participants analysed=participants with available data.|||SDS score||Standard Deviation|Mean
2664655|NCT01541215|Secondary|Height Velocity SDS|Height velocity SDS scores at week 26. Height velocity is change in height per year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by time between those measurement time points and multiplied by 365 days. Height velocity SDS was calculated using following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below −3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Safety analysis set. Number of participants analysed=participants with available data.|||SDS score||Standard Deviation|Mean
2664656|NCT01541215|Secondary|Growth (Height Velocity)|Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.|Week 0, week 52|Safety analysis set. Number of participants analysed=participants with available data.|||cm/year||Standard Deviation|Mean
2664657|NCT01541215|Secondary|Growth (Height Velocity)|Growth (i.e., height velocity) is the change in height per year and is measured in cm/year. The height velocity was calculated as the difference between current height and height at baseline (week 0) divided by the time (in days) between those measurement time points and multiplied by 365 days.|Week 0, week 26|Safety analysis set. Number of participants analysed=participants with available data.|||cm/year||Standard Deviation|Mean
2664658|NCT01541215|Secondary|Pubertal Assessment/Progression (Tanner Staging)|Pubertal development was assessed in 3 areas (breast, penis and pubic hair development) by the Tanner staging in accordance with stages I-V. The Tanner staging assessment was no longer required to be performed once a subject reached the Tanner stage V, as judged by the investigator. Reported results are number of participants at different Tanner stages at week 0, week 26 and week 52.|Week 0, week 26, week 52|Safety analysis set. Number of participants analysed=participants with available data|||Participants|||Count of Participants
2664659|NCT01541215|Secondary|Change in Bone Age Assessment (X-ray of Left Hand and Wrist)|Change in bone age from baseline to week 52. If the baseline (week 0) bone age assessment indicated that all epiphyses were fused, then the assessment was not repeated at week 52.|Week 0, week 52|Safety analysis set. Number of participants analysed=participants with available data.|||years||Standard Deviation|Mean
2664660|NCT01541215|Secondary|Change From Baseline in Height SDS|Change in height SDS from baseline to week 52. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below −3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Safety analysis set. Number of participants analysed=participants with available data.|||SDS score||Standard Deviation|Mean
2664661|NCT01541215|Secondary|Change From Baseline in Height SDS|Change in height SDS from baseline to week 26. Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below −3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Safety analysis set. Number of participants analysed=participants with available data.|||SDS score||Standard Deviation|Mean
2664662|NCT01541215|Secondary|Change From Baseline in Pulse|Change from baseline in pulse 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Safety analysis set. Number of participants analysed=participants with available data.|||beats/minute||Standard Deviation|Mean
2664663|NCT01541215|Secondary|Change From Baseline in Pulse|Change from baseline in pulse 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Safety analysis set – included all subjects receiving at least one dose of liraglutide/placebo (134 subjects). Number of participants analysed=participants with available data.|||beats/minute||Standard Deviation|Mean
2664664|NCT01541215|Secondary|Ratio to Baseline: Free Fatty Acids|Ratio to baseline (free fatty acids) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664667|NCT01541215|Secondary|Ratio to Baseline: Triglycerides|Ratio to baseline (triglycerides) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664668|NCT01541215|Secondary|Ratio to Baseline: HDL Cholesterol|Ratio to baseline (HDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664669|NCT01541215|Secondary|Ratio to Baseline: High-density Lipoprotein (HDL) Cholesterol|Ratio to baseline (HDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664670|NCT01541215|Secondary|Ratio to Baseline: VLDL Cholesterol|Ratio to baseline (VLDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664671|NCT01541215|Secondary|Ratio to Baseline: Very Low-density Lipoprotein (VLDL) Cholesterol|Ratio to baseline (VLDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664672|NCT01541215|Secondary|Ratio to Baseline: LDL Cholesterol|Ratio to baseline (LDL cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664673|NCT01541215|Secondary|Ratio to Baseline: Low Density Lipoprotein (LDL) Cholesterol|Ratio to baseline (LDL cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664674|NCT01541215|Secondary|Ratio to Baseline: Total Cholesterol|Ratio to baseline (total cholesterol) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664675|NCT01541215|Secondary|Ratio to Baseline: Total Cholesterol|Ratio to baseline (total cholesterol) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664676|NCT01541215|Secondary|Ratio to Baseline: HOMA-IR|Ratio to baseline (HOMA-IR) after 52 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664677|NCT01541215|Secondary|Ratio to Baseline: Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)|Ratio to baseline (HOMA-IR) after 26 weeks. HOMA-IR is an index of insulin resistance and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664678|NCT01541215|Secondary|Ratio to Baseline: HOMA-B|Ratio to baseline (HOMA-B) after 52 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664679|NCT01541215|Secondary|Ratio to Baseline: Homeostasis Model Assessment of Beta-cell Function (HOMA-B)|Ratio to baseline (HOMA-B) after 26 weeks. HOMA-B is an index of beta-cell function and was calculated from fasting insulin. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664680|NCT01541215|Secondary|Ratio to Baseline: Fasting C-peptide|Ratio to baseline (fasting C-peptide) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664681|NCT01541215|Secondary|Ratio to Baseline: Fasting C-peptide|Ratio to baseline (fasting C-peptide) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664682|NCT01541215|Secondary|Ratio to Baseline: Fasting Glucagon|Ratio to baseline (fasting glucagon) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664875|NCT01538862|Secondary|Surface Area of Nonhealing Erosions|Change in surface area of one or two nonhealing erosions|7 days|Time frame was originally entered as 30 days. This was not consistent with the protocol which listed a 7 day time frame for this Outcome|||percentage change||Standard Deviation|Mean
2664683|NCT01541215|Secondary|Ratio to Baseline: Fasting Glucagon|Ratio to baseline (fasting glucagon) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664684|NCT01541215|Secondary|Ratio to Baseline: Pro-insulin/Insulin Ratio|Ratio to baseline (Pro-insulin/insulin ratio) after week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664685|NCT01541215|Secondary|Ratio to Baseline: Pro-insulin/Insulin Ratio|Ratio to baseline (Pro-insulin/insulin ratio) after week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664686|NCT01541215|Secondary|Ratio to Baseline: Fasting Pro-insulin|Ratio to baseline (fasting pro-insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664687|NCT01541215|Secondary|Ratio to Baseline: Fasting Pro-insulin|Ratio to baseline (fasting pro-insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664688|NCT01541215|Secondary|Ratio to Baseline: Fasting Insulin|Ratio to baseline (fasting insulin) at week 52. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664689|NCT01541215|Secondary|Ratio to Baseline: Fasting Insulin|Ratio to baseline (fasting insulin) at week 26. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set. Number of participants analysed=participants with available data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2664690|NCT01541215|Secondary|Change in Blood Pressure (Systolic and Diastolic Blood Pressure)|Change in blood pressure (systolic and diastolic blood pressure) after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of participants analysed=participants with available data.|||mmHg||Standard Deviation|Mean
2664691|NCT01541215|Secondary|Change in Blood Pressure (Systolic and Diastolic Blood Pressure)|Change in blood pressure (systolic and diastolic blood pressure) after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set. Number of participants analysed=participants with available data.|||mmHg||Standard Deviation|Mean
2664692|NCT01541215|Secondary|Change From Baseline in BMI Standard Deviation Score (SDS)|Change in BMI SDS from baseline to week 52. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below −3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of participants analysed=participants with available data.|||SDS score||Standard Deviation|Mean
2664693|NCT01541215|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of participants analysed=participants with available data.|||kg||Standard Deviation|Mean
2664694|NCT01541215|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set. Number of participants analysed=participants with available data.|||kg||Standard Deviation|Mean
2664695|NCT01541215|Secondary|Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)|Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of analysed=participants with available data.|||mmol/L||Standard Deviation|Mean
2664696|NCT01541215|Secondary|Change in Mean Post-prandial Increment Across All Three Meals (Breakfast, Lunch, and Dinner)|Change in mean post-prandial increment across all three meals (breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set. Number of analysed=participants with available data.|||mmol/L||Standard Deviation|Mean
2664709|NCT01541215|Secondary|Number of Subjects Having HbA1c Below 7.0%|Number of subjects achieving HbA1c <7.0% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 52|Full analysis set. Number of participants analysed=participants with available data.|||Participants|||Count of Participants
2664697|NCT01541215|Secondary|Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)|Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 52 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of analysed=participants with available data for specified timepoints.|||mmol/L||Standard Deviation|Mean
2664698|NCT01541215|Secondary|Change in Post-prandial Increments (From Before Meal to 90 Min After Breakfast, Lunch, and Dinner)|Change in post-prandial increments (from before meal to 90 min after breakfast, lunch, and dinner) after 26 weeks. Post-prandial increment for each meal (breakfast, lunch, and dinner) was derived from the 7-point SMPG profile as the difference between post-prandial plasma glucose values and the plasma glucose values before the meal. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set. Number of analysed=participants with available data for specified timepoints.|||mmol/L||Standard Deviation|Mean
2664699|NCT01541215|Secondary|Change From Baseline in 7-point Self-measured Plasma Glucose|Change in mean 7-point self-measured plasma glucose after 52 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of participants analysed=participants with available data.|||mmol/L||Standard Deviation|Mean
2664700|NCT01541215|Secondary|Change in Mean 7-point Self-measured Plasma Glucose|Change in mean 7-point self-measured plasma glucose after 26 weeks. Subjects were instructed to measure their plasma glucose at following timepoints: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner and at bedtime. Mean 7-point SMPG was defined as the area under the profile (calculated using the trapezoidal method) divided by time. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set. Number of participants analysed=participants with available data.|||mmol/L||Standard Deviation|Mean
2664701|NCT01541215|Secondary|Change in FPG|Change in FPG from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of participants analysed=participants with available data.|||mmol/L||Standard Deviation|Mean
2664702|NCT01541215|Secondary|Change in HbA1c|Change in HbA1c from baseline to week 52. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 52|Full analysis set. Number of participants analysed=participants with available data.|||percentage of HbA1c||Standard Deviation|Mean
2664703|NCT01541215|Secondary|Number of Subjects Having HbA1c Below 7.5%|Number of subjects achieving HbA1c <7.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 52|Full analysis set. Number of participants analysed=participants with available data.|||Participants|||Count of Participants
2664704|NCT01541215|Secondary|Number of Subjects Having HbA1c Below 7.5%|Number of subjects achieving HbA1c <7.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 26|Full analysis set. Number of participants analysed=participants with available data.|||Participants|||Count of Participants
2664705|NCT01541215|Secondary|Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes|"Number of subjects achieving HbA1c <7.0% without severe or minor hypoglycaemic episodes after 52 weeks.~Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.~Minor hypoglycaemia was defined as meeting either of the below criteria:~an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself~any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication."|Week 52|Full analysis set. Number of participants analysed=participants with available data.|||Participants|||Count of Participants
2664706|NCT01541215|Secondary|Number of Subjects Having HbA1c Below 7.0% Without Severe or Minor Hypoglycaemic Episodes|"Number of subjects achieving HbA1c <7.0% without severe or minor hypoglycaemic episodes after 26 weeks.~Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.~Minor hypoglycaemia was defined as meeting either of the below criteria:~an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or plasma glucose <3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself~any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or plasma glucose value <3.1 mmol/L (56 mg/dL) All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication."|Week 26|Full analysis set. Number of participants analysed=participants with available data.|||Participants|||Count of Participants
2664707|NCT01541215|Secondary|Number of Subjects Having HbA1c Maximum 6.5%|Number of subjects achieving HbA1c <=6.5% after 52 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 52|Full analysis set. Number of participants analysed=participants with available data.|||Participants|||Count of Participants
2664708|NCT01541215|Secondary|Number of Subjects Having HbA1c Maximum 6.5%|Number of subjects achieving HbA1c <=6.5% after 26 weeks. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 26|Full analysis set. Number of participants analysed=participants with available data.|||Participants|||Count of Participants
2664710|NCT01541215|Secondary|Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS)|Change in BMI SDS from baseline to week 26. BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below −3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set.|||SDS score||Standard Error|Least Squares Mean
2664711|NCT01541215|Secondary|Number of Subjects Having HbA1c Below 7.0%|Percentage of subjects having HbA1c <7.0%. All available data were used for the analysis including data collected after treatment discontinuation and initiation of rescue medication.|Week 26|Full analysis set.|||Percentage of subjects|||Number
2664712|NCT01541215|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change in FPG from baseline to week 26. All available data were used for the analysis, including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set.|||mmol/L||Standard Error|Least Squares Mean
2664713|NCT01541215|Primary|Change in HbA1c (Glycosylated Haemoglobin)|Change in HbA1c from baseline to week 26. All available data were used for the primary analysis, including data collected after treatment discontinuation and initiation of rescue medication.|Week 0, week 26|Full analysis set.|||Percentage of HbA1c||Standard Error|Least Squares Mean
2664714|NCT01540981|Secondary|Change in Mean Wound Area|Measured from randomization to last visit (14 days or at discharge from hospital)|14 days||||square centimeters||Standard Deviation|Mean
2664715|NCT01540981|Primary|Effectiveness|"To compare between the treatment groups the effect of the assigned study treatment on the rate of progression of DTI to advanced stage pressure ulcer (Stage III or greater, continued DTI, or a pressure ulcer that is unable to be staged due to necrotic tissue).~Stage I - Intact skin with non-blanchable redness of a localized area Stage II - Partial thickness loss of dermis Stage III - Full thickness loss, subcutaneous fat may be visible Stage IV - Full thickness tissue loss with exposed bone, tendon or muscle Unstageable - Full thickness tissue loss in which the base of the ulcer is covered by slough or eschar Continues deep tissue injury - purple or maroon localize area of discolored intact skin that may be mushy or boggy"|14 days||||participants|||Number
2664716|NCT01540851|Secondary|Range of Motion|Percentage of participants able to bend knee at least 120 degrees|6 months after TKA|Percentage of participants who self-reported on their 6 month questionnaire that they were able to bend their index knee to greater than 120 degrees|||percentage of participants|||Number
2664717|NCT01540851|Secondary|Satisfaction|Percentage of patients in each study arm who reported being very satisfied with the results of TKA|Measured at 6 months post TKA|The proportion of participants who reported being very satisfied with the results of TKA was assessed using a 5-item Likert scale on the 6 month follow-up questionnaire|||percentage of participants|||Number
2664718|NCT01540851|Primary|Change in WOMAC Physical Function|The change in functional status will be measured using the WOMAC Physical Function scale at Baseline and 6 months|Change in functional status from baseline to 6 months|The WOMAC Physical Function scale is scaled from 0 to 100, with 100 worst. Change in function was calculated as the WOMAC Physical Function score at 6 months minus the WOMAC Physical Function score at baseline|||units on a scale||95% Confidence Interval|Mean
2664719|NCT01540838|Secondary|Death or Severe Neurological Sequelae at Discharge|Death or severe neurological sequelae, defined as blindness, tetraplegia/paresis, hydrocephalus requiring a shunt and severe psychomotor retardation|Examined at discharge from hospital. The longest hospital stay was 84 days.|All patients who received at least one dose of treatment, and of whom information on severe neurological sequelae was available at discharge from hospital.|||Participants|||Count of Participants
2664720|NCT01540838|Secondary|Death or Any Neurological Sequelae at Discharge From Hospital.|Defined as death or any severe neurological sequelae, or hemi- or monoparesis, or ataxia, or psychomotor retardation of any degree.|Examined at discharge from hospital. The longest hospital stay was 84 days.|All patients who hade received at least one dose of treatment, and of whom information on any neurological sequelae was available at discharge from hospital.|||Participants|||Count of Participants
2664721|NCT01540838|Secondary|Number of Participants With Deafness|Hearing thresholds (in decibel, dB) were determined by brainstem evoked response audiometry (BERA), for each ear separately. Deafness was defined as a hearing threshold >80 dB in the better ear.|This outcome includes hearing thresholds determined at earliest seven days after the institution of treatment, during the hospital stay. The longest hospital stay was 84 days.|We were finally able to perform post-treatment audiological examinations in solely 37 participants.|||Participants|||Count of Participants
2664722|NCT01540838|Secondary|Death or Severe Neurological Sequelae on Day 7|Death or severe neurological sequelae, defined as blindness, tetraplegia/paresis, hydrocephalus requiring a shunt and severe psychomotor retardation|Examined on day 7 since institution of treatment|All patients who received at least one dose of treatment, and of whom information on severe neurological sequelae was available on day 7.|||Participants|||Count of Participants
2664723|NCT01540838|Secondary|A Change in Hearing Threshold Compared to the First Test Result|Hearing thresholds (in decibel, dB) were determined by brainstem evoked response audiometry (BERA), for each ear separately. The better ear's hearing threshold, obtained on admission or shortly thereafter, was compared with the better ear's hearing threshold obtained at earliest after one week of treatment.|Hearing thresholds obtained during any of the first three days after hospital admission were compared with hearing thresholds obtained on day seven or later, during the hospital stay. The longest hospital stay was 84 days.|We were finally able to perform post-treatment audiological examinations in solely 37 participants, and 10 of these lacked primary audiological examinations. Thus, this outcome is reported for 27 participants.|||dB||Inter-Quartile Range|Median
2664724|NCT01540838|Secondary|Death or Any Neurological Sequelae on Day 7|Defined as death or any severe neurological sequelae, or hemi- or monoparesis, or ataxia, or psychomotor retardation of any degree.|Examined on day 7 since institution of treatment.|All patients who had received at least one dose of treatment, and from whom the information on any neurological sequelae was available on day 7.|||Participants|||Count of Participants
2664725|NCT01540838|Secondary|Status on the Modified Glasgow Outcome Scale|"Scores on the modified Glasgow Outcome Scale which range from a maximum of 5 (best) to a minimum of 1 (worst) points.~The Glasgow Outcome Scale categorizes the outcome after brain injury into five categories, based on the level and severeness of disability. As hearing impairment is one of the most common sequelae of bacterial meningitis, an assessment of hearing should be included when estimating the grade of disability.~Hearing thresholds (in decibel, dB) were determined by brainstem evoked response audiometry (BERA), for each ear separately."|Examined at discharge from hospital, except for hearing evaluations which were performed at earliest seven days since the institution of treatment, during the hospital stay. The longest hospital stay was 84 days.|We were finally able to perform post-treatment audiological examinations in solely 37 participants, of whom one lacked information on the neurological outcome. Thus, the Glasgow Outcome Scale score could be estimated for 36 participants.|||score on a scale||Inter-Quartile Range|Median
2664726|NCT01540838|Secondary|All Deaths During Hospital Stay|All patients who had received at least one dose of treatment and died during the hospital stay.|The outcome was assessed each day until the patient was discharged from the hospital. The longest hospital stay was 84 days, while the last death occurred 39 days after treatment initiation.|All patients who had received at least one dose of treatment.|||Participants|||Count of Participants
2664727|NCT01540838|Primary|Day 7 Mortality|All patients who had received at least one dose of treatment and were dead on day 7 from the institution of treatment on day 1.|On day 7 from the institution of treatment|All participants who received at least one dose of treatment.|||Participants|||Count of Participants
2664728|NCT01540825|Primary|Assessment of Tolerability by the Investigator|Assessment of tolerability by the investigator assessed according to the categories good, satisfactory, not satisfactory, bad and not assessable.|End of study visit, up to day 10|Treated set|||Percentage of participants|||Number
2664729|NCT01540825|Primary|Percentage of Participants With Drug-related Adverse Events|Percentage of participants with drug-related adverse events|From administration of study drug until end-of-study visit, up to 10 days|Treated set|||Percentage of participants|||Number
2664730|NCT01540825|Secondary|t1/2|Terminal half-life of the analyte in plasma (t1/2)|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set|||Hours||Geometric Coefficient of Variation|Geometric Mean
2664731|NCT01540825|Secondary|AUC0-infinity|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2664732|NCT01540825|Secondary|AUC0-tz|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2664733|NCT01540825|Secondary|Tmax|Time from dosing to maximum measured concentration of the analyte in plasma (Tmax)|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set|||Hours||Full Range|Median
2664734|NCT01540825|Secondary|Cmax|"Maximum measured concentration of the analyte in plasma (Cmax).~The analysis population was the pharmacokinetic (PK) set which included all subjects randomised and treated with study medication who provided at least 1 evaluable observation for a PK endpoint of Area Under the Concentration-time Curve from 0 to infinity (AUC0-inf), Area Under the Concentration-time Curve from 0 to the last quantifiable data point (AUC0-tz) and Cmax and who had no important protocol violations relevant to the evaluation of PK."|Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration|PK set|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2664735|NCT01540825|Primary|Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test|Clinically relevant abnormalities for clinical laboratory evaluation, vital signs, lung function, carbon monoxide Diffusing Capacity Of the Lung (DLCO), Electrocardiogram (ECG), physical examination, orthostasis test, oxygen saturation or haemoccult test|From administration of study drug until end-of-study visit, up to 10 days|Treated set|||Percentage of participants|||Number
2664736|NCT01540773|Secondary|Insulin-like Growth Factor 1|Measure IGF-1 8 hours following the administration of the capsules containing the proprietary amino acid derivative blend or placebo|8 hours following administration||||ng/mL||Standard Deviation|Mean
2664737|NCT01540773|Primary|Area Under the Curve of Growth Hormone Over Baseline|Measure human growth hormone at times 0-120 minutes on two occasions about one week apart. On one occasion, the proprietary amino acid derivative blend will be given orally at time 0 in capsule form, and on the other occasion the capsules will contain no amino acids.|0-120 minutes, at Baseline and post dose, week 1 and week 3||||min*ng/mL||95% Confidence Interval|Mean
2664738|NCT01540773|Primary|Change From Baseline of Growth Hormone|Measure human growth hormone at times 0-120 minutes on two occasions about one week apart. On one occasion, the proprietary amino acid derivative blend will be given orally at time 0 in capsule form, and on the other occasion the capsules will contain no amino acids.|0-120 minutes, at Baseline and post dose, week 1 and week 3||||nanograms/ml||95% Confidence Interval|Mean
2664739|NCT01540565|Other Pre-specified|BRCA Mutation in Primary Tumor Tissue|BRCA mutational status will be tabulated against the germline mutation to see what proportion of patients have a mutation reversal within the tumor and whether such reversals can explain resistance to the regimen under study.|Baseline|Data not collected||||||
2664755|NCT01540487|Primary|Maximum Measured Concentration (Cmax) of Linagliptin.||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|Treated Set.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2664740|NCT01540565|Other Pre-specified|SNPs With DNA Repair Genes, Tumor Response, PFS, OS, and Patient Demographics (e.g. Age, Race, Tumor Grade)|If the clinical trial goes to the second stage and there is sufficient variability in the SNPs, then patients can be categorized by the nature of their SNPs and assessed for prognostic value through survival analysis (e.g. log-rank tests and Cox proportional hazards modeling). If the variability in SNPs is relatively low, assessment of prognostic value can be conducted with odds ratios of patients responding or surviving progression-free for at least 6 months. These techniques will use exact methods such as Fisher's exact test.|Baseline|Data not collected||||||
2664741|NCT01540565|Secondary|The Proportion of Patients Who Survive Progression-free for at Least 6 Months|This outcome captures whether or not the patient survived progression-free for at least 6 months, and is displayed as a proportion.|6 months|Eligible and evaluable|||Proportion of patients||95% Confidence Interval|Number
2664742|NCT01540565|Secondary|Duration of OS|Overall survival|Every cycle while patient is receiving protocol therapy. Patients will be monitored for survival after going off therapy for a 5 year period, every 3 months for the first 2 years, then every 6 months for the last 3 years.|Eligible and evaluable|||Months||Inter-Quartile Range|Median
2664743|NCT01540565|Secondary|Duration of PFS|The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (and >= 5 mm increase of target lesions), or a measurable increase in a non-target lesion, or the appearance of new lesions.|CT scan/MRI if used to follow lesion for measurable disease every other cycle for the first 6 months, then every 3 months until progression. Patients who begin subsequent therapy without progression will be monitored for PFS for 5 years.|Eligible and evaluable|||months||90% Confidence Interval|Median
2664744|NCT01540565|Primary|Proportion of Patients With Adverse Events as Assessed by CTCAE v4.0|Patients with grade 3 or greater Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.|After every cycle while on study therapy. Followed for late adverse events up to 30 days after completing therapy.|Eligible and evaluable|||Proportion of patients||95% Confidence Interval|Number
2664745|NCT01540565|Primary|Proportion of Patients With Complete and Partial Tumor Response|Patients with complete and partial tumor response by RECIST V1.1 (per response evaluation criteria in Solid Tumors Criteria (RECIST V1.1) for target lesions and assessed by MRI (CT scan): Complete Response (CR), disappearance of all target lesions (confirmed at >= 4 weeks); Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions (confirmed at >= 4 weeks); Overall Response = CR + PR.|CT scan/MRI if used to follow lesion for measurable disease every other cycle for the first 6 months, then every 3 months until progression. Repeat at other times if clinically indicated.Responses require confirmation at >= 4 wks from first documentation.|Eligible and evaluable|||Proportion of patients||95% Confidence Interval|Number
2664746|NCT01540513|Primary|Tumor to Blood Pool Ratios Post-imaging for Confirmed Malignant Tumors|Tumor to blood pool ratio (tumor SUVmax to superior sinus SUVmean) was calculated at each time point. Tumor to blood pool is calculated by using tumor/lesion SUVmax and dividing by blood pool SUVmean from placing a region of interest in the posterior sagittal sinus near the confluence of sinuses. Imaging performed at 24-, and 48 hours post injection.|24- and 48 hours post injection|Of 12 participants, 8 had evaluable tumor to blood pool ratio data.|||Ratio of PET SUV||Standard Deviation|Mean
2664747|NCT01540513|Primary|Tumor to Blood Pool Ratios Post-imaging for All Lesions With PET Uptake|Tumor to blood pool ratio (tumor SUVmax to superior sinus SUVmean) was calculated at each time point. Tumor to blood pool is calculated by using tumor/lesion SUVmax and dividing by blood pool SUVmean from placing a region of interest in the posterior sagittal sinus near the confluence of sinuses. Imaging performed at 24- and 48 hours post injection.|24- and 48 hours post injection|Of 12 participants, 8 had evaluable TBR data.|||Ratio of PET SUV||Standard Deviation|Mean
2664748|NCT01540513|Primary|Tumor to Background Ratios (TBR) Post-imaging for Confirmed Malignant Tumors|TBR is calculated by using tumor/lesion SUVmax and dividing by contralateral normal brain background SUVmean value. Imaging performed at 24-, and 48 hours post injection.|24- and 48 hours post injection|Of 12 participants, 8 had evaluable TBR data.|||Ratio of PET SUV||Standard Deviation|Mean
2664749|NCT01540513|Primary|Tumor to Background Ratios (TBR) Post-imaging for All Lesions With PET Uptake|TBR is calculated by using tumor/lesion SUVmax and dividing by contralateral normal brain background SUVmean value. Imaging performed at 24- and 48 hours post injection.|24- and 48 hours post injection|Of 12 subjects, only 8 had evaluable data.|||Ratio of PET SUV||Standard Deviation|Mean
2664750|NCT01540487|Secondary|AUC0-tz for Linagliptin||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|Treated Set|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2664751|NCT01540487|Secondary|AUC(0-infinity) for Metformin|AUC0-infinity is based on predicted last concentration values.|1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2664752|NCT01540487|Secondary|Area Under the Concentration Time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) for Linagliptin|AUC0-infinity is based on predicted last concentration values.|1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.||||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2664753|NCT01540487|Primary|Maximum Measured Concentration (Cmax) of Metformin||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2664754|NCT01540487|Primary|Area Under the Concentration-time Curve of Metformin in Plasma Over the Time Interval 0 to the Last Quantifiable Concentration (AUC0-tz)||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2664782|NCT01540045|Secondary|Body Mass Index|Body mass index, using the formula kg/m^2|Change from Baseline in threshold of perception and recognition at 6 weeks||||kg/m^2||Standard Deviation|Mean
2664756|NCT01540487|Primary|Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72)||1 hour (h) prior to drug administration, 20 minutes (min), 40 min, 1 h, 1 h 30 min, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 24 h, 34 h, 48 h and 72 h thereafter.|Treated Set.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2664757|NCT01540409|Primary|Change From Baseline in the Percentage of Dystrophin Positive Fibers (PDPF) at Week 48|Dystrophin expression as assessed by percent dystrophin positive fibers was measured by immunohistochemistry (IHC) technique using primary anti-dystrophin antibody. Percent change from baseline is the arithmetic difference of the treatment time point minus baseline divided by baseline calculated for individual subjects. Baseline here corresponds to the baseline in the parent study (4658-us-201, NCT01396239).|Parent Baseline and Week 48|The ITT population included all participants randomized into parent study 4658-us-201. Results are reported below in 3 reporting groups of placebo to eteplirsen, eteplirsen 30 mg/kg, and eteplirsen 50 mg/kg, respectively, based on evaluation period (Week 48) as applicable for this outcome measure.|||Percentage of Dystrophin Positive Fibers||Standard Deviation|Mean
2664758|NCT01540409|Primary|Change From Baseline in the 6 Minute Walk Test (6MWT) at Week 240|This study used a modified version of the 6MWT test procedure described in American Thoracic Society (ATS) 2002 guidelines, specifically adapted for patients with Duchenne muscular dystrophy. The participant was asked to walk a set course of 25 meters for 6 minutes (timed) and the distance walked in meters was recorded. Increases from baseline in 6MWT distance are indicative of improvement and decreases from baseline indicate worsening. Baseline here corresponds to the baseline in the parent study (4658-us-201, NCT01396239).|Parent Baseline and Week 240|The Intent-to-Treat Population (ITT) population included all participants randomized into parent study 4658-us-201. Here, “Overall Number of Participants Analyzed” signifies participants evaluable for this outcome measure. Results are reported below in 2 reporting groups based on evaluation period (Week 240) as applicable for this outcome measure.|||Meters||Standard Deviation|Mean
2664759|NCT01540370|Primary|Inter- Examiner Agreement in Angle Width by Goniometric Lens|Inter-rater agreement (among 6 raters) of Large Step angle width (range: 0.5 to 5.5 with 0.5 unit intervals) was evaluated using weighted kappa (Fleiss-Cohen) statistics. The angle is the area between the iris and cornea of the eye. Each examiner performed a pair of angle-width measurements by goniometric lens predilation (ie, 2 measurements per examiner). The degree of agreement within raters was interpreted according to Landis and Koch, where: <0:poor, 0.00-0.20:slight, 0.21-0.40:fair, 0.41-0.60:moderate, 0.61-0.80:substantial, and 0.81-1.00:almost perfect.|Day 1|Modified Intent to Treat: enrolled patients with unobstructed and measurable inferior angles by goniometric reading and anterior segment optical coherence tomography (OCT)|||Kappa statistics|||Number
2664760|NCT01540370|Primary|Intra- Examiner Agreement in Angle Width by Goniometric Lens|Intra-rater agreement (for each of the 6 raters) of Large Step angle width (range: 0.5 to 5.5 with 0.5 unit intervals) was evaluated using weighted kappa (Fleiss-Cohen) statistics. The angle is the area between the iris and cornea of the eye. Each examiner performed a pair of angle-width measurements by goniometric lens predilation (ie, 2 measurements per examiner). The degree of agreement within raters was interpreted according to Landis and Koch, where: <0:poor, 0.00-0.20:slight, 0.21-0.40:fair, 0.41-0.60:moderate, 0.61-0.80:substantial, and 0.81-1.00:almost perfect.|Day 1|Modified Intent to Treat: enrolled patients with unobstructed and measurable inferior angles by goniometric reading and anterior segment optical coherence tomography (OCT)|||Kappa statistics|||Number
2664761|NCT01540266|Secondary|Estimates of the Current Status||5 minutes|||||||
2664762|NCT01540266|Secondary|Estimates of the Quality of the Communication||5 minutes|||||||
2664763|NCT01540266|Primary|Number of Items Recalled From the Communication in the Video|The students in the structured condition and the students in the non-structured condition were independently shown a video in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form. The key memory measure of interest was immediate recall performance expressed as the number of items recalled from the overall 28 items in the two videos. Participants' recall protocols were evaluated by two independent raters, one of whom rated all protocols and the other, only a subset of them. Analyses of the agreement between the two raters resulted in a Cohen's kappa of 0.74, indicating substantial interrater reliability according to Landis and Koch (35). In case of disagreement between the two raters, consensus was reached through joint analysis and discussion of the protocols.|5 minutes||||number of items recalled||Standard Deviation|Mean
2664764|NCT01540162|Secondary|The Number (Rate) of Patients With Acute Respiratory Infections|ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia|first 12 month of life||||participants|||Number
2664765|NCT01540162|Secondary|The Number (Rate) of Patients With Acute Respiratory Infections|ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia|first 6 month of life||||participants|||Number
2664766|NCT01540162|Primary|The Number (Rate) of Patients With Acute Respiratory Infections|ARI: Acute Rhinitis, Acute Rhinopharyngitis, Acute Bronchitis, Acute Bronchiolitis and Pneumonia|first 28 days of life||||participants|||Number
2664767|NCT01540045|Primary|Dysgeusia (BITTER Dilutions Dichotomized)|We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami, bitter and sweet tastes|pre - post chemotherapy (6 weeks)||||participants|||Number
2664768|NCT01540045|Primary|Dysgeusia (SWEET Dilutions Dichotomized)|We divide dilutions in two groups and dichotomized the patients into high and low sensibility to sweet taste.|pre - post chemotherapy (6 weeks)|we dichotomized the patients into high or low sensibility to umami, bitter and sweet tastes pre-postchemotherapy|||participants|||Number
2664769|NCT01540045|Primary|Dysgeusia (UMAMI Dilutions Dichotomized)|We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami taste. (perception)|pre - post chemotherapy (6 weeks)||||participants|||Number
2664783|NCT01540045|Secondary|BODY COMPOSITION|fat mass and lean body mass pre-post chemotherapy|Change from Baseline in perception and recognition thresholds at 6 weeks||||kg||Standard Deviation|Mean
2664864|NCT01539083|Secondary|Overall Survival (OS)|OS was defined as the time between randomization and death. Death of a participant regardless of the cause was considered as an event.|Up to 5 years|All randomized analysis set was defined as participants in the all enrolled set (all participants with a non-missing informed consent date and were not screen failures) who were randomized to receive consolidation treatment.|||months||95% Confidence Interval|Median
2664770|NCT01540045|Primary|Dysgeusia (BITTER Recognition)|"Describe the recognition threshold (RT) of bitter taste with 5 dilutions with different concentrations.~The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks||||μmol/ml||Full Range|Median
2664771|NCT01540045|Primary|Dysgeusia (BITTER Perception)|"Describe the perception threshold (PT) of bitter taste with 5 dilutions with different concentrations.~The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks||||μmol/ml||Full Range|Mean
2664772|NCT01540045|Primary|Dysgeusia (SWEET Recognition)|"Describe the recognition threshold (RT) of sweet taste with 5 dilutions with different concentrations.~The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks||||μmol/ml||Full Range|Median
2664773|NCT01540045|Primary|Dysgeusia (SWEET Perception)|"Describe the threshold perception (PT) of sweet taste with 5 dilutions with different concentrations.~The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks|For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.|||μmol/ml||Full Range|Median
2664774|NCT01540045|Secondary|Global Status of Quality of Life (C-30,LC13 EORTC)|"differences in global status of QoL scale (C-30,LC13 EORTC) between those with more or less sensibility to recognize the umami taste.~score of scale 0-100, a higher score represents better overall state."|time between baseline and before 2 cycles of chemotherapy, an average of 6 weeks||||units on a scale||Inter-Quartile Range|Median
2664775|NCT01540045|Secondary|Peripheral Neuropathy (QLQ-C30 Version 3, EORTC)|comparison of peripheral neuropathy patients who increased or decreased their sensibility to the PT of umami taste The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating.|participants were followed for the duration of 2 cycles of chemotherapy, an average of 6 weeks||||Units on a scale||Full Range|Median
2664776|NCT01540045|Secondary|Change From Baseline in Albumin After 2 Cycles of Chemotherapy|comparison of patients who increased or decreased their sensibility to the PT of umami taste|participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks||||g/dL||Standard Deviation|Mean
2664777|NCT01540045|Secondary|Quality o f Life|The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). [18, 19] Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating.|participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks||||Scores on a scale||Full Range|Median
2664778|NCT01540045|Primary|Dysgeusia (UMAMI Recognition)|"Describe the threshold recognition (RT) of umami with 5 dilutions with different concentrations.~The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks|For the paired analysis of taste acuity we used Wilcoxon for difference between baseline and 6 weeks later.|||μmol/ml||Full Range|Median
2664779|NCT01540045|Secondary|IRON Consumption|IRON consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy|participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks||||mg||Standard Deviation|Mean
2664780|NCT01540045|Secondary|PROTEIN AND FAT Consumption|energy and nutrimental consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs < Sweet perception thresholds after chemotherapy|participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks||||gr||Standard Deviation|Mean
2664781|NCT01540045|Secondary|Subjective Global Assessment|validated questionnaire to identify patients with malnutrition or risk of malnutrition Subjective global assessment (PG-SGA) was used to assess and classify patients as having severe or moderate malnourishment (B or C) or as being well nourished (A).|descriptive values before chemotherapy||||participants|||Number
2664784|NCT01540045|Primary|Dysgeusia (UMAMI Perception)|"Describe the threshold of perception and recognition (PT and RT, respectively) umami) with 5 dilutions with different concentrations.~The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste."|Change from Baseline in threshold of perception at 6 weeks||||μmol/ml||Full Range|Median
2664785|NCT01539980|Secondary|Liver Enzyme (AST)|Large, open wound may absorb some materials from wound dressing. If those materials are toxic, liver enzyme (a major organ for elimination of any toxicities) will be increased.|Within 14 days after operation||||u/L||Standard Deviation|Mean
2664786|NCT01539980|Secondary|Proinflammatory Cytokines (IL)|The proinflammatory cytokines from wound exudate will be measured for predicting the inflammatory level. ELISA kit is used.|Within 14 days after operation||||pg/mL||Standard Deviation|Mean
2664787|NCT01539980|Secondary|Pain Levels of Wounds|Pain may occur on operation wounds. Visual analog scale is used by patients themselves for monitoring the pain level with 0 = no pain, 10 = worst possible pain.|Within 14 days after operation||||units on a scale||Standard Deviation|Mean
2664788|NCT01539980|Secondary|Clinical Safety of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment|Number of patients with infected wound|Within 14 days after operation||||Number of patients with infected wound|||Number
2664789|NCT01539980|Primary|Clinical Efficacy of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment|Time for complete epithalization is duration between finishing surgical procedure and the dressing spontaneously peeling off from donor sites without causing pain. The wounds completely close and without fluid leakage and are able to exposed to the environment without pain. This duration should not exceed than 14 days.|Within 14 days after operation||||Days||Standard Deviation|Mean
2664790|NCT01539811|Secondary|Length of Antibiotics|Length of antibiotic|6 weeks|||||||
2664791|NCT01539811|Secondary|Hospital Stay|Length of hospital stay, total cost of hospital stay|2 weeks|||||||
2664792|NCT01539811|Secondary|Clearance of Infection|Clearance of infection (as determined by negative culture, normal complete blood count (CBC), erythrocyte sedimentation rate (ESR), and C-Reactive protein (CRP)|6 weeks|||||||
2664793|NCT01539811|Secondary|Reinfection/Reintervention|Reinfection or Reintervention to the operative site|3 months|||||||
2664794|NCT01539811|Primary|Wound Healing|Wound healing at 3 months (75% epithelialization) from the time of the final definitive operation.|3 months|||||||
2664795|NCT01539759|Secondary|Women's Satisfaction With IUDs||0-6 months postpartum||||percentage of participants satisfied|||Number
2664796|NCT01539759|Secondary|IUD Expulsion||0-6 months postpartum||||participants|||Number
2664797|NCT01539759|Primary|IUD Use|The use of an IUD at 6 months postpartum is the primary outcome measure|6 months postpartum||||participants|||Number
2664798|NCT01539642|Primary|Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48).|"SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. The range of SPID48 scores were -232 to 326.~Time-weighted SPID48 = ∑ [T(i) - T(i-1)] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 hours.~Note: Active group n=114 and placebo group n=58, instead of active n=115 and placebo n=57, due to one active patient receiving placebo inadvertently."|48 hours||||Units on a scale||Standard Error|Least Squares Mean
2664799|NCT01539590|Secondary|Symptoms and Clinical Signs of CHF|Symptoms and clinical signs of CHF measured by NYHA classification|6 months|||||||
2664800|NCT01539590|Secondary|Change in Body Weight||6 months|||||||
2664801|NCT01539590|Secondary|Change From Baseline eCrCl||6 months|||||||
2664802|NCT01539590|Secondary|Development of Ventricular Fibrillation or Other Life-threatening Arrhythmia||6 months|||||||
2664803|NCT01539590|Secondary|All-cause Mortality||6 months|||||||
2664804|NCT01539590|Secondary|Frequency of MACCE||6 months|||||||
2664805|NCT01539590|Secondary|Frequency of AE, SAEs||6 months|||||||
2664806|NCT01539590|Secondary|Incidence of Complete ST Segment Resolution 60 ± 30 Minutes After Last Angiogram||6 months|||||||
2664807|NCT01539590|Secondary|Number of Hospitalizations for CHF Through 6 Months||6 months|||||||
2664808|NCT01539590|Secondary|Frequency of New Onset CHF Through 6 Months||6 months|||||||
2664809|NCT01539590|Secondary|Frequency of MACE||6 months|||||||
2664810|NCT01539590|Secondary|Change in Regional Myocardial Radial, Circumferential and Longitudinal Strain||1 and 6 months|||||||
2664811|NCT01539590|Secondary|Change Between Initial Semi-quantitative Regional Wall Motion Score (17 Segment Model) by Echocardiography||1 and 6 months|||||||
2664812|NCT01539590|Secondary|LVEDVI, LVESVI and LVEF After MI Assessed by 2D and 3D Echocardiography||6 months|||||||
2664813|NCT01539590|Secondary|Change in LVEDVI, LVESVI and LV Ejection Fraction (EF) After MI Assessed by Cine MR (SSFP Imaging)||6 months|||||||
2664814|NCT01539590|Secondary|Change in Symptoms and Clinical Signs of CHF||6 months|||||||
2664815|NCT01539590|Secondary|Change in BNP Levels||6 months|||||||
2664816|NCT01539590|Secondary|Change in CK-MB and Troponin||6 months|||||||
2664817|NCT01539590|Primary|Evaluation of the Degree of Late Ventricular Remodeling|Evaluation of the degree of late ventricular remodeling between the BB3 and placebo treatment groups at 6 months, as measured by increase in LV end-diastolic volume index (LVEDVI) from initial MR image (day 5±1) to late MR image (6 months).|6 months|||||||
2668593|NCT01504971|Primary|Diagnostic Ability of Each Endoscopic Finding for GERD Symptom.|Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month|1 month||||percentage of participants||95% Confidence Interval|Number
2664818|NCT01539590|Primary|Evaluation of Reduction in Infarct Size|Evaluation of reduction in infarct size by MRI between the BB3 and placebo treatment groups at 6 months based on index of myocardial salvage|6 month|Five subjects were enrolled into the study; 3 subjects were randomized to BB3 and 2 subjects to placebo. Of the 3 subjects randomized to BB3, 1 completed study treatment; all three subjects discontinued the study prematurely. The two subjects randomized to placebo completed study treatment and neither discontinued the study prematurely.||||||
2664819|NCT01539538|Primary|Patient Global Satisfaction|Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control|48 hours||||% patients reporting good or excellent||95% Confidence Interval|Number
2664820|NCT01539525|Secondary|Mean Cost for Each Intervention|The data table includes the mean cost for implementation of each intervention from the societal perspective. The costs do not include the research costs|6 months|This outcome was restricted to participants who had a time stamp for their intervention (n=11 were missing) and had all 6 months of follow-up data.|||dollars|participants|Standard Deviation|Mean
2664821|NCT01539525|Secondary|Rates of STDs|rates of incident std's per patient's medical records|baseline to 6 months||||participants|||Number
2664822|NCT01539525|Primary|Treatment Utilization|Treatment utilization assessed via participant self-report at each follow-up interview, and with the exception of self-help groups, verified with providers. We also reviewed the medical record for use of medication indicative of treatment (e.g., nicotine replacement therapy).|baseline to 6 months||||participants|||Number
2664823|NCT01539525|Primary|Days Per Month of Primary Substance Use|Participants completed a timeline followback at each assessment, reporting days of primary substance use. Outcomes reported are raw means and standard deviations.|7 non-overlapping monthly intervals from baseline to month 6||||days per month||Standard Deviation|Mean
2664824|NCT01539512|Secondary|Complete Response Rate|Complete response rate was defined as the percentage of participants who achieved a complete response.|Up to 17 months|ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.|||percentage of participants|||Number
2664825|NCT01539512|Secondary|Overall Survival|Overall survival was defined as the interval from randomization to death from any cause.|Up to 17 months|ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.|||months||95% Confidence Interval|Median
2664826|NCT01539512|Secondary|Lymph Node Response Rate|Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the SPD of index lymph nodes.|Up to 17 months|ITT Analysis Set: randomized participants with treatment group designated according to initial randomization|||percentage of participants||95% Confidence Interval|Number
2664827|NCT01539512|Secondary|Overall Response Rate|"Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response.~Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate & biopsy.~Partial response was defined as >1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, > 100000/μL platelets, > 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors."|Up to 17 months|ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.|||percentage of participants||95% Confidence Interval|Number
2664828|NCT01539512|Primary|Progression-Free Survival|Progression-free survival was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. Definitive disease progression was CLL progression based on standard criteria (other than lymphocytosis alone) as defined by the 2008 update of the International Workshop on CLL guidelines, ie, appearance of any new lesion; increase by ≥ 50% in the sum of the products of the perpendicular diameters of measured lymph nodes (SPD); new or ≥ 50% enlargement of liver or spleen; transformation to a more aggressive histology (eg, Richter's or prolymphocytic transformation); reduction in the number of blood cells (cytopenia) attributable to CLL.|Up to 17 months|Intent-to-Treat (ITT) Analysis Set: randomized participants with treatment group designated according to initial randomization.|||months||95% Confidence Interval|Median
2664829|NCT01539317|Secondary|Improvement of Quality of Sexual Life - Visit 3|To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by average scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function).|Visit 3 (End of Study)|Averaged scores of Sexual Function Questionnaire at Visit 1 scoring from the prior 30 days.|||Units on a scale||Inter-Quartile Range|Mean
2664830|NCT01539317|Secondary|Improvement of Quality of Sexual Life - Visit 2|To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by averaged scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function).|Visit 2 (Week 4)|Averaged scores of Sexual Function Questionnaire at Visit 2 scoring from the prior 30 days.|||Units on a scale||Inter-Quartile Range|Mean
2664849|NCT01539291|Secondary|Duration of Response (DOR)|DOR was defined as the time interval from the first documentation of CR or PR to the earlier of the first documentation of definitive disease progression or death from any cause. DOR was analyzed using KM estimates.|From first documentation of CR or PR to end of study GS-US-312-0117 (maximum: up to 67.6 months)|Participants in the Full Analysis Set who achieved a CR or PR were analyzed.|||months||95% Confidence Interval|Median
2664831|NCT01539317|Primary|Location of Pain in Postmenopausal Dyspareunia|"To determine the specific site of vulvovaginal tenderness in menopausal breast cancer survivors who have entry dyspareunia. Examine the vulvar vestibule with a swab test to determine locations and severity of touch tenderness. Eight sites were evaluated around the vaginal opening and there location was in reference to a clock face. Measured using the Numerical Rating Scale, a scale which measures pain from 0 to 10 with 0=no pain and 10=the worst pain you have ever felt."|Enrollment visit||||units on a scale from 0 to 10||Inter-Quartile Range|Median
2664832|NCT01539317|Secondary|Improvement of Quality of Sexual Life - Visit 1|To determine whether women's quality of sexual life is improved by use of this local therapy to prevent pain with intercourse. Measured by average scores on the Sexual Function Questionnaire. There are 8 domains measured in the Sexual Function Questionnaire each asking for a score for the prior 30 days: Desire (score range 5-31; ≥23 considered normal function), Arousal-sensation (score range 4-20; ≥14 considered normal function), Arousal-lubrication (score ranges 2-10; ≥8 considered normal function), Arousal-cognitive (score range 2-10; ≥8 considered normal function), Orgasm (score range 1-15; ≥12 considered normal function), Pain (2-15; ≥12 considered normal function), Enjoyment (score range 6-30; ≥23 considered normal function) and Partner (score range 2-10; ≥8 considered normal function).|Visit 1 (Enrollment)|Averaged scores of Sexual Function Questionnaire Visit 1 each time scoring from the prior 30 days.|||units on a scale||Inter-Quartile Range|Mean
2664833|NCT01539317|Primary|Prevention of Entry Dyspareunia With Non-hormonal Therapy|"Mean intercourse pain reported by subjects using the Numerical Rating Scale pain ratings (range 0-10, 0 being no pain and 10 being worst possible pain). Testing was during weeks 0-4 (Phase II) (with blinded randomization for placebo vs active intervention medication) and testing was during weeks 5-12 (Phase III) (with open-label active medication for 8 weeks after completing the blinded 4 weeks). Subjects agreed to try penetration twice per week and score their pain using the Numerical Rating Scale pain ratings.The scores were averaged during each phase."|During Phase II (0-4 weeks) and during Phase III (5-12 weeks)||||Units on a scale||Inter-Quartile Range|Mean
2664834|NCT01539291|Secondary|Change in Health Status as Assessed Using the EuroQoL Five-Dimension (EQ-5D) Utility Measure|Change in health status was defined as the change from baseline in overall health and single-item dimension scores as assessed using the EQ-5D utility measure. Percentage of participants with different level of problem were reported. Level 1: indicated no problem; Level 2: indicated some problems; and Level 3: indicated extreme problems. For participants who did not enter Study GS-US-312-0117, baseline values were from Study GS-US-312-0116.|Study GS-US-312-0116 or GS-US-312-0117 Baseline; Weeks 24 and 48|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2664835|NCT01539291|Secondary|Plasma Trough (Predose) and Peak (1.5 Hours Postdose) Concentrations of Idelalisib||Weeks 4, 12, and 24|Participants in the pharmacokinetic (PK) Analysis Set (participants in the Full Analysis Set who had the necessary baseline and on-study measurements to provide interpretable results for the specific parameters of interest) with available data were analyzed.|||ng/mL||Inter-Quartile Range|Median
2664836|NCT01539291|Secondary|Study Drug Compliance as Assessed by the Percentage of Participants Adhering to Treatment|Adherence percentage was calculated as the sum of tablets dispensed - the sum of tablets returned divided by the sum of the overall dosing period (total daily tablets x dosing duration), taking into account investigator-prescribed interruptions.|First IDL dose date in study GS-US-312-0116 or GS-US-312-0117 to last IDL dose date in study GS-US-312-0117 (maximum: 67.3 months)|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2664837|NCT01539291|Secondary|Overall Change From Baseline in the Plasma Concentrations of Disease-Associated Chemokines and Cytokines|The percent of average on-treatment biomarker concentration of baseline (%Baseline) was used to evaluate the overall pharmacodynamics change on the biomarkers with IDL treatment. The average on-treatment biomarker concentration is calculated using area under curve (AUC) following the trapezoidal rule. The biomarkers with median AUC value of 100 indicated no overall on-treatment biomarker changes compared to the baseline. The biomarkers with median AUC value greater than 100 or less than 100 indicated an increase or decrease, respectively, on-treatment biomarker changes from the baseline.|GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)|The cytokine and T-cell subsets biomarker analysis set included all participants who received at least one dose of study drug, consented for optional future study, and had at least one evaluable measurement for any biomarker at any visit on IDL treatment. Available samples were batched for analysis as prespecified.|||percentage of baseline||Full Range|Median
2664838|NCT01539291|Secondary|Changes From Baseline in Phosphatidylinositol 3-kinase (PI3Kδ)/Akt/Mammalian Target of Rapamycin (mTOR) Pathway Activation as a Measure of PI3Kδ Pathway Activity||GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)|Data were not collected because there was insufficient volume of sample (not enough material) to perform the analysis for any participant.||||||
2664839|NCT01539291|Secondary|Best Change From Baseline in Karnofsky Performance Status (KPS)|KPS is a tool used to measure the ability to perform ordinary tasks. The score ranges from 0 to 100, with a higher score indicating that the participant is better able to carry out daily activities. Best change from baseline was defined as the highest value of change from baseline among all postbaseline visits. For participants who did not enter Study GS-US-312-0117, baseline values were from Study GS-US-312-0116.|Study GS-US-312-0116 or GS-US-312-0117 Baseline up to Week 190|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2664850|NCT01539291|Secondary|Time to Response (TTR)|TTR was defined as the time interval from start of study therapy to the first documentation of CR or PR.|GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)|Participants in the Full Analysis Set who achieved a CR or PR were analyzed.|||months||Inter-Quartile Range|Median
2664851|NCT01539291|Secondary|Complete Response (CR) Rate|CR rate was defined as the percentage of participants who achieved a CR (full definition in Protocol Amendment 9, Section 7.5.1). The determination of CLL response and progression were based on standardized IWCLL criteria, as specifically modified for this study to reflect current recommendations which considered the mechanism of action of idelalisib and similar drugs.|GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2664840|NCT01539291|Secondary|Best Change From Baseline in Health-Related Quality of Life (HRQL) Domain and Symptom Scores Based on the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) Questionnaire|"The FACT-Leu questionnaire included subscales for physical well-being (PWB, 7 items), social/family well-being (SWB, 7 items), emotional well-being (EWB, 6 items), functional well-being (FWB, 7 items), and additional concerns or Leukemia-Specific Subscale (LeuS, 17 items). The FACT-Leu scoring guide identified those negatively stated items that must have been reversed before being added to obtain subscale totals. Negatively stated items were reversed by subtracting the response from 4. After reversing proper items, all subscale items were summed to get total subscale scores with the range of 0-28, 0-28, 0-24, 0-28, 0-68 for PWB, SWB, EWB, FWB, and LeuS, respectively. FACT-Leu total score ranged from 0 to 176. Higher scores indicated a better quality of life. Best change from baseline was defined as the highest value of change from baseline among all postbaseline visits. For participants who did not enter Study GS-US-312-0117, baseline values were from Study GS-US-312-0116."|Study GS-US-312-0116 or GS-US-312-0117 Baseline up to Week 184|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2664841|NCT01539291|Secondary|Overall Survival|Overall survival was defined as the time interval from start of study therapy to death from any cause. Overall survival was analyzed using KM estimates. Data presented includes all available survival information from Study GS-US-312-0116 (including data in long-term follow-up) and Study GS-US-312-0117 (including any data in long-term follow-up) up to the database finalization dates. Data from surviving participants were censored at the last time that the participant was known to be alive on study or long-term follow-up. Data presented includes all participants who were randomized to Study GS-US-312-0116 regardless if they entered Study GS-US-312-0117 or not.|GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)|Per the analysis plan, overall survival data was analyzed in the ITT Analysis Set (participants who were randomized in the study) by treatment group according to the original randomization in Study GS-US-312-0116, regardless of whether participants received any study drug, or received a different regimen from the regimen they were randomized to.|||months||95% Confidence Interval|Median
2664842|NCT01539291|Secondary|Neutrophil Response Rate|Neutrophil response rate was defined as the percentage of participants with baseline neutropenia (absolute neutrophil count [ANC] ≤ 1.5 x 10^9/L) who achieved an ANC > 1.5 x 10^9/L or demonstrated a ≥ 50% increase in ANC from baseline; ANC values within 4 weeks of post-baseline or after 2 weeks of receiving exogenous growth factors (eg, filgrastim, granulocyte-colony stimulating factor [G-CSF], lenograstim) or after 4 weeks of receiving Neulasta® were excluded from response evaluation.|GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)|Participants in the Full Analysis Set who had neutropenia (ANC ≤ 1.5 × 10^9/L) at baseline and at least 1 evaluable postbaseline value were analyzed.|||percentage of participants||95% Confidence Interval|Number
2664843|NCT01539291|Secondary|Hemoglobin Response Rate|Hemoglobin response rate was defined as the percentage of participants with baseline anemia (hemoglobin < 110 g/L [11.0 g/dL]) who achieved an on-study hemoglobin ≥ 110 g/L (11.0 g/dL) or demonstrated a ≥ 50% increase in hemoglobin from baseline; hemoglobin values within 4 weeks post-baseline or after 4 weeks of receiving packed cell/whole blood transfusion or after 6 weeks of receiving exogenous growth factors (eg, darbepoetin alfa) were excluded from the hemoglobin response evaluation.|GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)|Participants in the Full Analysis Set who had anemia (hemoglobin < 110 g/L [11 g/dL]) at baseline and at least 1 evaluable postbaseline value were analyzed.|||percentage of participants||95% Confidence Interval|Number
2664844|NCT01539291|Secondary|Platelet Response Rate|Platelet response rate was defined as the percentage of participants with baseline thrombocytopenia (platelet count < 100 x 10^9/L) who achieved an on-study platelet count ≥ 100 x 10^9/L or demonstrated a ≥ 50% increase in platelet count from baseline; platelet values within 4 weeks post-baseline or after 8 days post transfusion were excluded from the platelet response rate evaluation.|GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)|Participants in the Full Analysis Set who had thrombocytopenia (platelet count < 100 × 10^9/L) at baseline and at least 1 evaluable postbaseline value were analyzed.|||percentage of participants||95% Confidence Interval|Number
2664845|NCT01539291|Secondary|Absolute Lymphocyte Count (ALC) Response Rate|ALC response rate was defined as the percentage of participants with baseline lymphocytosis (ALC ≥ 4 x 10^9 cells/L) who achieved an on-study ALC < 4 x 10^9 cells/L or demonstrated a ≥ 50% decrease in ALC from baseline; ALC values within 4 weeks post-baseline were excluded from the ALC response rate evaluation.|GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)|Participants in the Full Analysis Set who had lymphocytosis (ALC ≥ 4 × 10^9/L) at baseline and at least 1 evaluable postbaseline value were analyzed.|||percentage of participants||95% Confidence Interval|Number
2664846|NCT01539291|Secondary|Hepatomegaly Response Rate|Hepatomegaly response rate was defined as the percentage of participants with baseline hepatomegaly who achieved an on-study normalization or a 50% decrease (minimum 2 cm) from baseline in the hepatic LVD (by imaging).|GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)|Participants in the Full Analysis Set who had hepatomegaly at baseline and at least 1 evaluable postbaseline liver measurement were analyzed.|||percentage of participants||95% Confidence Interval|Number
2664847|NCT01539291|Secondary|Splenomegaly Response Rate|Splenomegaly response rate was defined as the percentage of participants with baseline splenomegaly who achieved an on-study normalization or a 50% decrease (minimum 2 cm) from baseline in the enlargement of the splenic longest vertical dimension (LVD) (by imaging).|GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)|Participants in the Full Analysis Set who had splenomegaly at baseline and at least 1 evaluable postbaseline spleen measurement were analyzed.|||percentage of participants||95% Confidence Interval|Number
2664848|NCT01539291|Secondary|Best Percent Change in Lymph Node Area|The best percent change from baseline in lymph node area (SPD) was defined as the largest decrease in tumor size during the study. The baseline SPD was the last value prior to the baseline reference date. For the participants who only had increases in tumor size from baseline, the smallest increase was considered as the best change from baseline in SPD.|GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)|Participants in the Full Analysis Set with available data were analyzed.|||percent change||Inter-Quartile Range|Median
2664852|NCT01539291|Secondary|Lymph Node Response Rate|Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lymph nodes.|GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2664853|NCT01539291|Secondary|Overall Response Rate (ORR)|ORR was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR). The determination of CLL response and progression were based on standardized International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria, as specifically modified for this study to reflect current recommendations which considered the mechanism of action of idelalisib and similar drugs. CR and PR are defined in Protocol Amendment 9, Sections 7.5.1 and 7.5.2.|GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2664854|NCT01539291|Primary|Safety: Percentage of Participants With Any Treatment-Emergent Adverse Events (TEAE), ≥ Grade 3 TEAE, Study Drug-Related TEAE, ≥ Grade 3 Study Drug-Related TEAE, Serious TEAE, Study Drug-Related Serious TEAE, and TEAE Leading to Study Drug Discontinuation|"The TEAEs were defined as events in a given study period that met one of the following criteria:~Events with onset dates on or after the start of treatment and up to 30 days after the permanent discontinuation of the study treatment.~The continuing adverse events (AEs) diagnosed prior to the start of treatment and worsened in severity grade, or non-serious AEs at baseline which became serious, or AEs resulting in treatment discontinuation after the start of treatment.~The severity of AEs was graded by the investigator according to the common terminology criteria for adverse events (CTCAE), Version 4.03, whenever possible. The relationship of an AE to study drug (idelalisib) was assessed using clinical judgment by the investigator, describing the event as either unrelated or related. Events for which the investigator did not record relationship to study drug were considered related to study drug."|First IDL dose date in study GS-US-312-0116 or GS-US-312-0117 to last IDL dose date in study GS-US-312-0117 (maximum: 67.3 months) plus 4 weeks|Participants in the Full Analysis Set were analyzed.|||percentage of participants|||Number
2664855|NCT01539291|Primary|Progression-Free Survival (PFS)|PFS was defined as the interval from the start of study therapy to the earlier of the first documentation of definitive disease progression or death from any cause; definitive disease progression is chronic lymphocytic leukemia (CLL) progression based on standard criteria other than lymphocytosis alone. PFS was analyzed using Kaplan-Meier (KM) estimates.|GS-US-312-0116 Baseline to end of study GS-US-312-0117 (maximum: up to 67.6 months)|Full Analysis Set included participants in the Intent-to-Treat (ITT) Analysis Set (all participants randomized in Study GS-US-312-0116) who received ≥ 1 dose of IDL, with treatment assignments designated according to randomization in Study GS-US-312-0116.|||months||95% Confidence Interval|Median
2664856|NCT01539239|Secondary|Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups.|Mean diurnal IOP change from baseline at 24 months between both groups after washout of topical glaucoma medications.|Baseline and 24 months|Intent-to-Treat (ITT)|||mmHg||Standard Deviation|Mean
2664857|NCT01539239|Primary|Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout.|Percentage of eyes in which diurnal IOP was reduced by greater than or equal to 20% at 24 months postoperative compared to baseline after washout of topical glaucoma medications.|Baseline and 24 months|Intent-to-Treat (ITT)|||percentage of eyes|Eyes||Number
2664858|NCT01539135|Secondary|Number of Participants With Unanticipated Intensive Care Unit Admission|Incidence of unscheduled Intensive Care Unit admission after surgery and length of ICU stay if applicable.|Time from discharge from PACU to discharge from hospital up to 72 hours||||participants|||Number
2664859|NCT01539135|Secondary|Number of Participants With Postoperative Pneumonia|Diagnosis of postoperative pneumonia during the 30 day follow up period after surgery|Up to 30 days after surgery||||participants|||Number
2664860|NCT01539135|Secondary|Length of Hospital Stay|Time of readiness for discharge from PACU, defined as when an Aldrete score of greater than or equal to 8 is given, to the time at which discharge (from the hospital) orders are written. The inpatient period may extend up to 72 hours.|Time from discharge from PACU to discharge from hospital up to 72 hours||||hours||Standard Deviation|Mean
2664861|NCT01539135|Primary|Number of Participants With Dye Leakage|Blue dye will be instilled above the endotracheal tube cuff immediately after intubation where it will remain for the duration of the surgery. The presence of dye leakage past the endotracheal tube cuff will be determined via analysis of bronchoscopic images taken at the end of the surgical procedure when surgical closure has begun.|Duration of surgical procedure - from 2 to 12 hours||||participants|||Number
2664862|NCT01539083|Secondary|Consolidation Phase: Change From Baseline in FACT/GOG-NTX Total Score at the End of the Consolidation Phase|Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) consists of 10 items and evaluates symptoms and concerns associated specifically with chemotherapy-induced neuropathy. 1 FACT/GOG-NTX total score has a range of 0 to 108 with a higher score indicating better quality of life.|Baseline, Month 12|All treated randomized analysis set was defined as participants in the all enrolled set (participants with non-missing informed consent date,not screen failures) received at least 1 dose of any study drug and randomized to receive consolidation treatment. Here, 'N'(number of participants analyzed) participants who were evaluable for this endpoint.|||units on a scale||Standard Deviation|Mean
2664863|NCT01539083|Secondary|Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase|The assessment of quality of life-6D (AQoL-6D) is a multi-attribute health-related quality of life instrument (QoL). It comprises dimension scores for independent living, relationships, mental health, coping, pain, senses, and utility score for AQol-6D. Each scale ranges between 1 (best QoL) and -0.04 (worst possible QoL).|Baseline, Month 12|All treated randomized analysis set was defined as participants in the all enrolled set (participants with non-missing informed consent date,not screen failures) received at least 1 dose of any study drug and randomized to receive consolidation treatment. Here, 'N'(number of participants analyzed) participants who were evaluable for this endpoint.|||units on a scale||Standard Deviation|Mean
2664874|NCT01538862|Secondary|Overall Improved Symptomatology|Overall clinical improvement in symptomatology and/or findings, as assessed by either the patient or parent. This would include decrease in the number and size of blister and erosions, decreased pain, improved comfort of the patient.|28 days||||Participants|||Count of Participants
2664865|NCT01539083|Secondary|Disease-free Survival (DFS)|DFS, defined as the duration from the start of CR to the time of relapse from CR. DFS applied only to participants in CR. CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow. Relapse from CR: reappearance of serum or urine M-protein by immunofixation or electrophoresis; development of >= 5 percent plasma cells in the bone marrow; appearance of any other sign of progression (ie, new plasmacytoma, lytic bone lesion, or hypercalcaemia).|Up to 5 years|Response-evaluable-randomized analysis set defined as all participants in the response-evaluable-induction set (who received at least 1 dose of study medication;had measurable disease at baseline) who were randomized to receive consolidation treatment. Here, ‘N’ (number of participants analyzed) signifies the participants who had complete response.|||months||95% Confidence Interval|Median
2664866|NCT01539083|Secondary|Progression Free Survival (PFS)|PFS, calculated as the time between randomization to disease progression or death (regardless of cause), whichever occurred first. Progressive disease as per IMWG criteria: increase of >= 25 percent from lowest response level in Serum M-component and/or (the absolute increase must be >=0.5 gram per deciliter [g/dL]) Urine M-component and/or (the absolute increase must be >=200 mg/24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: the absolute percent must be >=10 percent. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.65 millimole per liter (mmol/L) that can be attributed solely to the plasma cell proliferative disorder.|Baseline until progressive disease (up to 5 years)|All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.|||months||95% Confidence Interval|Median
2664867|NCT01539083|Secondary|Consolidation Phase: Percentage of Participants With Stringent Complete Response (sCR) at Months 3, 6, 9 and 12|sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow. CR is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow.|Months 3, 6, 9 and 12|All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.|||percentage of participants|||Number
2664868|NCT01539083|Secondary|Consolidation Phase: Percentage of Participants With Complete Response (CR) at Months 3, 6, 9 and 12|CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5 percent plasma cells in bone marrow.|Months 3, 6, 9 and 12|All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.|||percentage of participants|||Number
2664869|NCT01539083|Primary|Consolidation Phase: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) at Month 12|CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90 percent or greater reduction in serum M-protein plus urine M-protein level <100 milligram (mg) per 24 hours.|Month 12|All response-evaluable-randomized analysis set was defined as all participants in the response-evaluable-induction set (all participants who received at least 1 dose of study medication in the induction phase and had measurable disease at baseline) who were randomized to receive consolidation treatment.|||percentage of participants|||Number
2664870|NCT01539070|Primary|Change in Score z of Body Mass Index From Baseline to 3 Months by Intervention Assignment|In order to calculate children's BMI and age and sex specific BMI z-scores at baseline and 3 month follow-up, study staff assessed child's height in meters and weight in kilograms. BMI was calculated as weight in kilograms divided by the square of height in meters.|0, 3 month||||z score||Standard Error|Mean
2664871|NCT01539070|Secondary|Number of Families That Completed 3 Month Follow-up in Intervention Group and Usual Care Group|We assessed the compliance with the study through attendiance appointments for assessing diet and physical activity.|3 months||||participants|||Number
2664872|NCT01539070|Primary|Change in Children´s Time of Physical Activity From Baseline to 3 Months by Intervention Assignment|Staff assisted parents in reporting the average time the participating child spent in pre-specified active and sedentary activities during the week and on weekends. For each of the pre-specified activities parents reported time spent in open-ended response format. From these responses we derived total hours/week of physical activity composed of active play (e.g. running, jumping, walking, playing ball, playing in the park, biking, swimming, dancing), as well as total hours/week of screen time, composed of television, DVD/video, and video and computer games.|0, 3 months|In intent-to-treat analyses, we used unadjusted and adjusted multivariate regression models, to examine differences from baseline to 3 and to 6 months between the intervention and usual care groups.|||hours/week||Standard Deviation|Mean
2664873|NCT01539070|Primary|Change in Children´s Consumption of Foods From Baseline to 3 Months by Intervention Assignment|We asked parents about the average number of servings in the week or month the child consumed each food. We constructed grouped diet variables corresponding to food categories : sweet snacks (sugar-sweetened dairy, sugary cereal, cookies, sweet bread, cake, packaged pastries ], caramel pops, candies and chocolates); fast food (hamburgers, pizza, hot dogs, quesadillas, fried tacos, French fries); savory snacks (packaged snack foods, corn or potato chips); fruit (orange, mango, papaya, watermelon, grapes, apple, banana); vegetables (chard, broccoli, jitomate [tomato], nopales [cactus], chayote [squash], spinach, lettuce, zucchini, carrot); sugar-sweetened beverages (soda, flavored milk, homemade [agua fresca] and packaged fruit drinks); and added sugar in beverages (teaspoons sugar or sweet flavoring added to milk, coffee, tea, or fruit juice).|0, 3 months|Intent-to-treat analyses with multiple imputation to account for missing data. Were included in the analysis of children between 0 and 3 BMI z score, age between 24 and 59 months and parents signed letter of consent to participate in the study|||servings/week||Standard Error|Mean
2664876|NCT01538862|Primary|Percent Change of Active Blisters and in Total Blister/Erosion Counts|Percent change of active blisters and in total blister/erosion counts from baseline to 7 days|7 days|Time frame was originally entered as 30 days. This was not consistent with the protocol which listed a 7 day time frame for this Outcome|||percent change||Standard Deviation|Mean
2664877|NCT01538719|Secondary|Change in Modified Rodnan Skin Score|Change in Modified Rodnan Skin Score over time. The fully validated modified version of the Rodnan skin thickness score was used. On this scale, a total of 17 skin sites are evaluated, including the face, upper arms, forearms, dorsum of the hands, fingers, chest, abdomen, thighs, forearms and feet. The total score can range from 0 to 51, with higher scores indicating greater severity of skin thickening and involvement (MRSS-51). Each of the 17 skin sites are scored from 0 to 3, where the following criteria apply: 0, normal skin; 1, thickened skin; 2, thickened and unable to pinch; and 3, thickened and unable to move. Scores from visit 3 (Day 42) and visit 1 (Day 0) were compared.|Visit 3 (Day 42) - Visit 1 (Day 0)||||Units on the Modified Rodnan Skin Score||Full Range|Mean
2664878|NCT01538719|Primary|Change in 2- Gene Biomarker|To investigate the effect of rilonacept on 2-gene biomarker expression in skin after treatment with rilonacept compared to pre-treatment 2-gene biomarker expression. These were measured at visit 3 (Day 42) and visit 1 (Day 0). This was calculated using a previously validated equation (MRSS = −27.6844 + [4.46(baseline THBS1)] + [5.31(ΔMS4A4A) + 4.96(ΔTHBS1)]). In this equation the expression of two genes (THBS1 and MS4A4) in collected samples are measured via nanostring, and then the expression levels of each gene are inserted into the equation in order to obtain the 2- gene biomarker score. A high biomarker score is equivalent to a high skin score, suggesting a higher severity of the disease.|Visit 3 (Day 42) - Visit 1 (Day 0)|Analysis run on 4 available samples in placebo arm.|||2- gene biomarkers score||95% Confidence Interval|Mean
2664879|NCT01538615|Secondary|Change in Number of Fruits and Vegetables Available in the Home|The HOME Food Inventory assesses which foods families currently have in their home from a list of items. Analyses controlled for child age and parent education.|Change from Baseline at 12 and 21 months|Numbers reported are for the child in the parent/child dyad. At post-intervention (12 months after baseline), 74 intervention children and 75 control children were measured. At follow-up (21 months after baseline) 70 intervention children and 73 control children were measured.|||number of fruits and vegetables||Standard Error|Least Squares Mean
2664880|NCT01538615|Secondary|Change in Target Children's Hours of Screen Time (Television Viewing, Video and Computer Game Playing) Per Week|Screen time will be measured with survey questions asking children how many hours per day they spend doing each sedentary activity (such as watching TV, using the computer, playing video games). Separate questions will be asked for week days and weekend days then the will be weighted to determine the hours of sedentary activity per week. Analyses controlled for child age and parent education at baseline.|Change from Baseline at 12 and 21 months|Numbers reported are for the child in the parent/child dyad. At post-intervention (12 months after baseline), 74 intervention children and 75 control children were measured. At follow-up (21 months after baseline) 70 intervention children and 73 control children were measured.|||hours per week||Standard Error|Least Squares Mean
2664881|NCT01538615|Secondary|Change in Target Children's Daily Intakes of Fruits and Vegetables|A trained interviewer will complete three 24-hour dietary recalls at each data collection time point with the child. The three days will be averaged to get an estimate of usual intake. Analyses controlled for child age and parent education at baseline.|Change from Baseline at 12 and 21 months|Numbers reported are for the child in the parent/child dyad. At post-intervention (12 months after baseline), 74 intervention children and 75 control children were measured. At follow-up (21 months after baseline) 70 intervention children and 73 control children were measured.|||average servings||Standard Error|Least Squares Mean
2664882|NCT01538615|Primary|Change in Child Body Mass Index (BMI Z-score)|Trained study staff will measure parent and child height and weight and use this to calculate body mass index (BMI). BMI values were than standardized for age and gender using CDC guidelines to obtain BMI z-scores. Analyses controlled for child age and parent education at baseline.|Change from Baseline at 12 and 21 months|Numbers reported are for the child in the parent/child dyad. At post-intervention (12 months after baseline), 74 intervention children and 75 control children were measured. At follow-up (21 months after baseline) 70 intervention children and 73 control children were measured.|||z-score||Standard Error|Least Squares Mean
2664883|NCT01538472|Primary|3-Year Overall Survival|Number of participants alive 3 years following treatment. Evaluations done every 3 months for 1 year and then every 6 months to check on the status of the disease.|3 years||||percentage of participants|||Number
2664884|NCT01538472|Primary|Overall Survival Median|Overall survival reported as number of days participants alive following treatment up to 5 years with annual follow up till disease progression. Evaluations done every 3 months for 1 year and then every 6 months for 5 years to check on the status of the disease, with long-term follow up as needed.|Participant followed from baseline treatment to 5 years, with study total period 8 years (study duration)||||days||Full Range|Median
2664885|NCT01538199|Post-Hoc|Change in Quick Inventory of Depressive Symptomatology-Self Rated Scale (QIDS-SR) Score|This is a brief (16-item) self-report inventory of core depressive symptoms such as sleep, depressed mood, appetite, concentration, suicidal ideation, interest, energy, psychomotor retardation or agitation. QIDS scores range from 0-27. Severity of depression can be judged based on the total score: 1-5 = No depression, 6-10 = Mild depression, 11-15 = Moderate depression. 16-20 = Severe depression, 21-27 = Very severe depression. Analyses were done for all evaluable subjects (participants who met the a priori cut-off of a minimum of four t-PBM sessions for inclusion in the study analyses) and treatment completers (participants who were followed for the entire 8-week study period and who received a clinical assessment immediately after). Pilot Study Group 2 excluded because no analyses were completed for this group (see participant flow)|Visit 1 (Baseline) and Visit 17 (Week 9)|Excluded: 3 randomized subjects who had <4 t-PBM treatments; 1 from Group 1 (unreliable reporting); 2 from Group 1 (started new treatment),1 from Group 2 (started therapy). 1 from Pilot study group 1 (no final visit). Pilot Study Group 2 excluded because there was no data (2 subjects dropped out, 1 subject ineligible--see Participant Flow).|||units on a scale||Standard Deviation|Mean
2665082|NCT01536405|Secondary|Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data|||Percentage of participants|||Number
2664886|NCT01538199|Secondary|Number of Participants With Adverse Events|"To assess the safety and tolerability of the TLT in depressed subjects: We predict that the TLT will be safe and well-tolerated by depressed patients, as assessed by the following rating scales: ADVERSE EVENTS FORM. We anticipate no significant differences in between TLT and Sham treatment as concerns side-effects.~Due to the small sample size and the variability of reported adverse events, we decided that descriptive reporting (i.e. reporting each subject's adverse events individually) was more appropriate than analysis. All adverse events were reported in the adverse events section. In the outcome measure data table below we report the number of participants in each group who experienced an adverse event."|Visits 1, 3, 5, 7, 9, 11, 13, 15, and 17|3 randomized subjects excluded from TLT analyses because they received <4 t-PBM treatments.|||Participants|||Count of Participants
2664887|NCT01538199|Secondary|Systematic Assessment for Treatment Emergent Events-systematic Inquiry (SAFTEE-SI)|"To assess the safety and tolerability of TLT in depressed subjects: We predict that TLT will be safe and well-tolerated, as assessed by the SAFTEE-SI. We anticipate no significant differences between TLT and Sham in side-effects.The SAFTEE is a commonly used instrument developed by the NIMH and adapted into a self-report instrument. The version we used is the same used by the NIMH-sponsored CO-MED trial. It examines all possible treatment-emergent side effects and adverse symptoms, including suicidal thoughts and behaviors, and self-injurious behavior.~The SAFTEE analyses are ongoing and will be reported in a second paper (they are not included in the primary outcomes paper). The single value analyzed is the total number of distinct treatment-emergent side-effects (a side effect is defined as any item on the SAFTEE for which severity increased by two or more levels from baseline to any visit) that occurred for each subject. Range: 0 to 165; higher values represent worse outcomes."|Assessed at odd-numbered Visits 1-17. The single value to be analyzed is the number of distinct side effects that occurred at least once during these assessment visits for each subject.|3 subjects excluded from TLT because they received <4 t-PBM treatments.1 excluded from Group 1 due to unreliable reporting.1 Group 1 and 1 Group 2 excluded due to no final visit score.1 excluded from Pilot Study Treatment Group 1 due to no final visit score.Pilot Study Treatment Group 2 excluded due to no data(drop out, post screen ineligibility).|||units on a scale||Standard Deviation|Mean
2664888|NCT01538199|Primary|Change in Hamilton Depression Rating Scale (HAM-D 17) Score|"We anticipate that TLT will decrease HAM-D17 scores in study subjects significantly more than Sham treatment. We expect that we will be also able to estimate the effect size of the antidepressant action of TLT. Analyses were done for all evaluable subjects (participants who met the a priori cut-off of a minimum of 4 t-PBM sessions for inclusion in the study analyses) and treatment completers (participants followed for the entire 8-week study period and who received a clinical assessment immediately after).~HAM-D17 questions are rated on a scale of 0-4 or 0-2 (total score: 0-50) with higher scores indicating more severe pathology. Scores typically fall into the following ranges: not depressed = 0-7; mildly depressed = 8-13; moderately depressed = 14-18; severely depressed = 19-22; very severely depressed = 23 and over.~For the pilot study, we analyzed subjects from Baseline to Week 8. A last observation carried forward (LOCF) was performed to account for one week 8n missing value."|Visit 1 (Baseline) and Visit 17 (Week 9); Pilot Phase: Visit 1 (Baseline) and Week 8|3 randomized subjects excluded from TLT analyses because they received <4 t-PBM treatments. 2 study completers from Group 1(last visit out of window,started new treatment ),1 subject from Group 2(started therapy)excluded as completers in analyses. Pilot Study Treatment Group 2 excluded because there was no data(drop out, post screen ineligibility).|||units on a scale||Standard Deviation|Mean
2664889|NCT01537900|Secondary|Plasma t½ of GZR|t1/2 is a measure of time for the maximum plasma concentration of GZR to decrease by 50%.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.||||||
2664890|NCT01537900|Secondary|Time to Maximum Plasma Concentration (Tmax) of GZR|Tmax is a measure of time to reach maximum post-dose plasma drug concentration.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.||||||
2664891|NCT01537900|Secondary|Lowest Plasma Concentration (Ctrough) of GZR|Ctrough is a measure of drug concentration 24 hours post-dose.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.||||||
2664892|NCT01537900|Secondary|Maximum Plasma Concentration (Cmax) of GZR|Cmax is a measure of the maximum plasma concentration post-dose.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.||||||
2664893|NCT01537900|Secondary|Plasma AUC[0-24 hr] of GZR|AUC0-24hr is a measure of the mean concentration of drug in plasma after dosing to 24 hours post-dose.|Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post-dose on Day 7|Plasma PK data were not collected due to liver PK results being deemed physiologically impossible.||||||
2664894|NCT01537900|Primary|Apparent Terminal Hepatic Half-life (t[H]½ ) of GZR|t(H)1/2 is a measure of the time required for the maximum post-dose liver concentration of GZR to decrease by 50%.|4, 8, 24, and 72 hours post-dose on Day 7|Apparent t(h)1/2 could not be estimated due to insufficient data in the terminal phase.||||||
2664895|NCT01537900|Primary|Hepatic Concentration of GZR (C[H]Xhr)|C(H)Xhr of GZR was expressed as liver concentration (μmol GZR/L liver) using the concentration of the extracted liver sample (mass of the liver biopsy/0.2 mL solvent), and assuming that liver has the specific gravity of water (1 g/mL). The arithmetic mean C(H)Xhr concentration is based on the means of 4 FNA passes per participant in all 4 participants.|4, 8, 24, and 72 hours post-dose on Day 7|The PPP includes all participants who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment.|||µM||Standard Deviation|Mean
2664908|NCT01537666|Secondary|Plasma Pharmacokinetics - Maximum Plasma Concentration (Cmax)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.~Cmax is the maximum observed concentration of a drug."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.|||ng/ml||Standard Deviation|Mean
2664896|NCT01537900|Primary|Estimated Area Under the Liver Concentration-time Curve for 24 Hours Post-dose (AUC[H]0-24hr) of Grazoprevir|Each participant was assigned to undergo Fine Needle Aspiration (FNA) to obtain liver tissue at different time points. Specifically, one participant underwent FNA at 4 hr post-dose only, another participant underwent FNA at 8 hr post-dose only, and a third participant underwent FNA at 24 hr post-dose only. (The fourth participant underwent FNA at 72 hr post-dose and therefore was not included in the calculation of AUC0-24hr.) Therefore, in calculating AUC0-24hr, there were only 3 data points: 1 data point at 4 hr post-dose, 1 data point at 8 hr post-dose, and 1 data point at 24 hr post-dose. The model assumed that drug concentration was at steady-state, and that the concentration at 24 hr post-dose was equal to the concentration at 0 hr post-dose.|4, 8, and 24 hours post-dose on Day 7|The per protocol population (PPP) includes all participants (4, 8, and 24 hr time points) who complied with the protocol sufficiently to ensure that the data were likely to exhibit the effects of treatment. As each data point was obtained from unique participants, there is no measure of variability.|||µM*hr|||Number
2664897|NCT01537887|Secondary|Percentage Change From Baseline to Day 11 in Fasting Lipids and Apolipoproteins||Baseline, Day 11|All participants who received at least one dose of study drug and had both baseline and post-baseline lipid or apolipoprotein (Apo) measurements on Day 11.|||percentage change||Standard Deviation|Mean
2664898|NCT01537887|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2484595 During One Dosing Interval at Steady State||Predose, 1, 2, 3, 4, 6, 12, 24, 72, and 168 Hours Postdose|Participants who received at least one dose of LY2484595 and had pharmacokinetic data.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2664899|NCT01537887|Secondary|Pharmacokinetics: Maximum Drug Concentration (Cmax) of LY2484595 During One Dosing Interval at Steady State||Predose, 1, 2, 3, 4, 6, 12, 24, 72, and 168 Hours Postdose|Participants who received at least one dose of LY2484595 and had pharmacokinetic data.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2664900|NCT01537887|Primary|Change From Baseline to Day 10 in QT Interval Corrected for Heart Rate (QTc) for LY2484595 Versus Placebo|Data were collected using a 12-lead electrocardiogram (ECG). The QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle and corrected for heart rate. Population-corrected QT interval (QTcP) formula: QTcP = QT / RR^ß, where ß is the population correction factor.|Predose of Day 1, Day 10|All participants who received at least one dose of study drug and had both baseline and post-baseline ECG measurements on Day 10.|||milliseconds (msec)||Standard Deviation|Mean
2664901|NCT01537835|Secondary|Assess for Methicillin Resistent Staphylococcus Aureus, Vancomycin Resistant Enterococci, and Gram-negative Bacterial Contamination on Healthcare Worker Uniform With Antimicrobial Properties Compared to Standard Healthcare Worker Uniform.|Number of healthcare workers with methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and resistant gram-negative bacteria on the three scrub types, all obtained after the eight-hour workday.|8 hours|Healthcare workers randomized to one of three types of uniform|||participants|||Number
2664902|NCT01537835|Primary|Total Bacterial Contamination of Healthcare Worker Uniform With Antimicrobial Properties Compared to Standard Healthcare Worker Uniform After an 8-hour Workday.|Total bacterial colony count of samples obtained from the breast or lower front pocket, the sleeve cuff of the dominant hand and the pant leg at the mid-thigh of the dominant leg on all scrubs after an eight-hour workday.|8 hours|healthcare workers randomized to one of three types of uniform.|||colony formation units||Inter-Quartile Range|Median
2664903|NCT01537783|Primary|Recurrence of Cutaneous Abscess|A patient's description that they have had another abscess since their index emergency department visit.|6 months||||Participants|||Count of Participants
2664904|NCT01537666|Secondary|Lung Pharmacokinetics - Minimum Sputum Concentration (Cmin)|"Sputum samples were obtained from the patients with cystic fibrosis to evaluate lung pharmacokinetics of vancomycin after a single dose administration of AeroVanc.~Cmin is the minimum observed concentration of a drug."|1, 8 and 24 hours post-dose|All CF patients who received a 32 mg dose of AeroVanc followed at least one week later by an 80 mg dose of AeroVanc (N=5). One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.|||µg/ml||Standard Deviation|Mean
2664905|NCT01537666|Secondary|Lung Pharmacokinetics - Maximum Sputum Concentration (Cmax)|"Sputum samples were obtained from the patients with cystic fibrosis to evaluate lung pharmacokinetics of vancomycin after a single dose administration of AeroVanc.~Cmax is the maximum observed concentration of a drug."|1, 8 and 24 hours post-dose|All CF patients who received a 32 mg dose of AeroVanc followed at least one week later by an 80 mg dose of AeroVanc (N=5). One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.|||µg/ml||Standard Deviation|Mean
2664906|NCT01537666|Secondary|Plasma Pharmacokinetics - Area Under the Plasma Concentration-time Curve From Time 0 to Infinite Time (AUCinf)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.~AUCinf is a way of estimating the total amount of drug exposure over an infinite time period."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.|||h*ng/ml||Standard Deviation|Mean
2664907|NCT01537666|Secondary|Plasma Pharmacokinetics - Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUCt)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.~AUCt is a way of expressing the total amount of drug exposure over a specified time period."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.|||h*ng/ml||Standard Deviation|Mean
2664940|NCT01537211|Secondary|Change in Berg Balance Score From Baseline|The Berg balance scale is used to assess balance during functional activities. It is a performance-based tool, scored between 0 and 56 with higher numbers indicating better balance.|After 3 month acclimation period to device||||score on a scale||Standard Deviation|Mean
2664909|NCT01537666|Secondary|Plasma Pharmacokinetics - Time to Reach the Maximum Plasma Concentration (Tmax)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.~Tmax is the time it takes to reach the maximum plasma concentration of a drug."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.|||Hours||Standard Deviation|Mean
2664910|NCT01537666|Secondary|Plasma Pharmacokinetics - Elimination Half Life (t½)|"Blood samples were obtained from the healthy volunteers to evaluate systemic pharmacokinetics of vancomycin after a single dose administration of AeroVanc or a single dose of IV vancomycin.~Half-life is the time it takes for the concentration of drug to decline by 50%."|Pre-dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose|All healthy volunteers (N=18) who received a single 16, 32, or 80 mg inhaled dose of AeroVanc. Subset (N=6 comprised of 2 patients from each of the AeroVanc groups) who received a single 250 mg IV dose of vancomycin.|||Hours||Standard Deviation|Mean
2664911|NCT01537666|Primary|Safety and Tolerability - Number of Participants With Treatment Emergent Adverse Events (TEAEs = Adverse Events That Started During or After the First Dose of Study Drug)|"Each participant was monitored regularly for Adverse Events (AEs) throughout the study. The Investigator or designee enquired about AEs by asking participants non-leading questions such as: How do you feel? or Have you had any (other) medical problems since your last visit/assessment? Additionally, several safety procedures (physical examinations, vital signs, safety laboratory tests, 12-lead ECGs, and spirometry) were conducted on participants at regular intervals. All AEs reported spontaneously by participants or in response to questioning or observation by the Investigator, including those related to safety procedures, were recorded. For each AE, the Investigator recorded the following assessments: seriousness, severity (Mild, Moderate, or Severe), and relationship to study drug (Not Related, Remote, Possible, Probable, or Highly Probable). AEs were considered drug-related if given a relationship of Possible, Probable, or Highly Probable."|Healthy volunteers = 2 weeks; CF Patients = 1 week|All 18 healthy volunteers who received single doses of AeroVanc, 6 of which also received a single dose of IV vancomycin. All 7 Cystic Fibrosis patients who received at least one single dose of AeroVanc.|||participants|||Number
2664912|NCT01537549|Secondary|Cerebral Oxidative Stress Markers|changes of cerebral lactate and glutathione levels as determined by magnetic resonance spectroscopy|at baseline and at week 5|per Protocol|||Ratio||Standard Deviation|Mean
2664913|NCT01537549|Primary|Adverse Events|Incidence and severity of adverse events|at 25 weeks|ITT|||Number of Adverse Events|||Number
2664914|NCT01537432|Secondary|Percentage of Participants Achieving Skin Histological Disease Reversal at Week 52|"Histological sections of lesional and nonlesional skin biopsies at Week 52 were examined. For each visit, each patient's lesional skin biopsy was scored for the degree of histological improvement compared to that patient's baseline disease on a five point scale; -~1 (worse) to +3 (excellent). Histological disease reversal or excellent improvement (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met."|Week 52|PharmacoDynamic PD -All patients with at least one evaluable post-treatment PD measurement and no protocol deviations with relevant impact on PD data.|||percentage of participants|||Number
2664915|NCT01537432|Primary|Percentage of Participants Achieving Skin Histology Response After Secukinumab Treatment From Baseline to Week 12|"Histological sections of lesional and nonlesional skin biopsies at baseline and at Week 12 were examined. For each visit, each patient's lesional skin biopsy was scored for the degree of histological improvement compared to that patient's baseline disease on a five point scale; -~1 (worse) to +3 (excellent). Histological disease reversal or excellent improvement (histological disease reversal score = 3) was declared at the endpoint when all of the following four criteria were met."|Baseline, Week 12|PharmacoDynamic PD -All patients with at least one evaluable post-treatment PD measurement and no protocol deviations with relevant impact on PD data.|||percentage of participants|||Number
2664916|NCT01537419|Secondary|Change in the Evidence of Family Conflict Between Parent and Youth After Intervention Between Intake and End of Treatment|The Self-Report of Family Functioning consists of 10 items selected from a number of well-known family assessment measures (Family Environment Scale, Family Concept Q-Sort, Family Adaptability and Cohesion Scale, and Family Assessment Measure). The scale ranges from 10 to 40, with a score of 10 being representative of no family conflict and a score of 40 being representative of the greatest magnitude of family conflict. Therefore, a decrease in score represents and decrease in self-reported family conflict.|16 weeks (end of treatment)||||units on a scale||Standard Deviation|Mean
2664917|NCT01537419|Primary|Change in the Severity of Depression Symptoms Between Intake and End of Treatment|Beck Depression Inventory-II. The second edition of the BDI is a widely-used, 21-item self-report instrument designed to assess the severity of depressive symptoms in adults and adolescents. The BDI-II has 21 items and takes approximately 5 minutes to complete. The scale ranges from 0 to 63, with a higher score being representative of a greater clinical magnitude of depression: a total score of 0-13 is considered minimal depression, 14-19 is mild depression, 20-28 is moderate depression, and 29-63 is severe depression.|16 weeks (end of treatment)||||units on a scale||Standard Deviation|Mean
2664918|NCT01537419|Primary|Change in the Intensity of Suicidal Ideation Between Intake and End of Treatment|The Suicidal Ideation Questionnaire-JR is a 15-item self-report assessment. It is based on Reynolds' theoretical notion of suicidality forming a continuum ranging from thoughts of death, thoughts of wanting to be dead, general and specific suicidal plans, preparations for carrying out plans, and actual suicide attempts. The scale ranges from 0 to 90, with a score of 0 being representative of no suicidal ideation, and a score of 31 or greater indicating severe suicidal ideation.|16 weeks (end of treatment)||||units on a scale||Standard Deviation|Mean
2664919|NCT01537393|Primary|Endothelial Cell Density (ECD)|Endothelial cell density at 3 years from surgery, conditional on graft survival at 3 years from surgery.|3 years from surgery|Eyes with graft success and a gradable image at 3 year (945 eyes of 769 unique participants)|||Cells per square millimeter|eyes|Standard Deviation|Mean
2664982|NCT01536704|Secondary|Elimination Rate Constant for Plasma Nicotine: K (el)|Kel was calculated with the help of plasma time concentration values.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.|||1/hr||Full Range|Median
2664920|NCT01537393|Primary|Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery|"Graft failure, defined as the occurrence of one of the following within 3 years of surgery:~Regrafting of the study eye for any reason~Cornea which remains cloudy without clearing, according to the following:~cloudy cornea on the first postoperative day which does not clear within 8 weeks OR~cloudy cornea which was initially clear postoperatively but becomes and remains cloudy for 3 months without clearing."|Study eye will be assessed for this outcome for 3 years following surgery|Analyzed number of eyes in each group (Overall 1090 unique participants)|||Eyes|Eyes||Count of Units
2664921|NCT01537367|Primary|The Percentage of Kept Divided by Scheduled Primary Care Visits, Excluding Cancelled (Second Measure).|Primary care visits are scheduled appointments for HIV-positive patients to see a physician, nurse practitioner, or physician assistant (a provider who can prescribe medication) at the HIV clinic.|12 months after enrollment|Intention to Treat (ITT)|||Percentage of Pt kept visits/#scheduled|||Number
2664922|NCT01537367|Secondary|Mean Counts Per Person (Rates) of Kept Visits.|The rate of kept clinic visits per person over 12 months.|12 months after enrollment||||# kept visits/person/12 months||Standard Error|Mean
2664923|NCT01537367|Primary|The Percentage of Patients Attending a Primary Care Visit in Each of 3 Four-month Periods (First Measure)|Kept visits for each patient were assessed in 4-month periods over the 12 months of the intervention. This is a binary measure, requiring attendance at least once in each of the three 4-month periods.|12 months after enrollment|Intention to Treat (ITT)|||percent in care each 4 month period|||Number
2664924|NCT01537315|Primary|Change From Baseline in Inflammatory Marker, Hs-C Reactive Protein, at 6 Months|Hs-CRP will be measured at baseline (before study drug) and at end of study (6 months). This marker is measured by ELISA assay from serum.|Baseline and 6 months||||ng/ml||Standard Deviation|Mean
2664925|NCT01537302|Secondary|Contrast/Flush Volumes|Evaluation of the contrast/flush volumes.|Day 0|||||||
2664926|NCT01537302|Secondary|Use of Assist Devices|Evaluation of the use of assist devices.|Day 0|||||||
2664927|NCT01537302|Secondary|Crossing Times|Evaluation of crossing times.|Day 0|||||||
2664928|NCT01537302|Secondary|Fluoroscopic Times|Evaluation of fluoroscopic times.|Day 0|||||||
2664929|NCT01537302|Secondary|Procedural Times|Evaluation of procedural times.|Day 0|||||||
2664930|NCT01537302|Secondary|Device Performance|Device performance as assessed by Investigator's input by evaluating both performance of the device and quality of the OCT image as it relates to the ability to identify layered and non-layered structures and the ability of the directional marker bands to aid in orientation of the catheter while advancing through the CTO.|Day 0|||||||
2664931|NCT01537302|Secondary|Technical Success|Successful delivery, crossing and retrieval of the investigational device without the use of an assist device.|Day 0|201 Enrolled|||participants|||Number
2664932|NCT01537302|Secondary|Procedural Success|Successful delivery, crossing and retrieval of the investigational device in the absence of in-hospital MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections.|Day 0|201 Enrolled|||participants|||Number
2664933|NCT01537302|Primary|Primary Efficacy Endpoint|Successful femoropopliteal CTO crossing using the Ocelot System as identified by guidewire placement in the distal true lumen confirmed by angiography.|Day 0|201 Enrolled|||participants|||Number
2664934|NCT01537302|Primary|Primary Safety Endpoint|No evidence of in-hospital MAEs, 30 day MAEs, clinically significant perforations, clinically significant embolizations or Grade C or greater dissections after Ocelot System CTO crossing confirmed by angiography.|Day 30|201 Enrolled, 2 Not Completed, 199 Analyzed|||participants|||Number
2664935|NCT01537211|Secondary|Change in Prosthesis Evaluation Questionnaire (PEQ) From Baseline|The Prosthesis Evaluation Questionnaire (PEQ) will be used to determine prosthesis preference. It is a questionnaire filled out by the subject that is sectioned into validated scales related to usage of the given prosthesis. These validated scales are ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility, and well being. Items included in these scales are scored between a minimum score of 0 and a maximum score of 100. Reported below are the averages of the validated scales. Thus, the average of each scale has a maximum score of 100 and a minimum score of 0, with a larger value indicating a more positive response.|After 3 month acclimation period to device||||score on a scale||Standard Deviation|Mean
2664936|NCT01537211|Secondary|Change in Community Participation Indicators From Baseline|The Community Participation Indicators questionnaire will be used to determine community and social participation. It is self-reported outcome measure for community participation. Different questions within the questionnaire correspond to two different aspects of community participation: involvement in life situations and control over participation. These two items are reported first in the table below. The minimum score is 0, and the maximum score is 100. Higher values correspond to higher levels of community participation. These two aspects can be further broken down into percentages of productive activities, social activities, and low-frequency activities performed often enough (the remaining reported values). Each of these percentages has a minimum score of zero and a maximum score of 100, with higher percentages indicating greater satisfaction with the frequency to which the activities are performed.|After 3 month acclimation period to device||||score on a scale||Standard Deviation|Mean
2664937|NCT01537211|Secondary|Change in Modified Falls Efficacy Scale From Baseline|The Modified Falls Efficacy Scale is used to determine falls and near-falls. It is a self-reported 14-item questionnaire filled out by the subject. Subjects answer questions about how confident they are in safely completing various tasks on a scale from 0 to 10, with 10 indicating greater confidence. The score below is the average item-score for the assessment.|After 3 month acclimation period to device||||score on a scale||Standard Deviation|Mean
2664938|NCT01537211|Secondary|Change in Four Square Step Test Time From Baseline|The four square step test assesses stepping and change of direction. The subject is asked to walk in a sequence across canes arranged to form four squares. The time to complete the sequence is reported in seconds.|After 3 month acclimation period to device||||seconds||Standard Deviation|Mean
2664939|NCT01537211|Secondary|Change in Timed Up and Go Test Time From Baseline|The Timed Up and Go (TUG) test is administered to quantify fall risk and functional mobility. TUG is the time taken for the subject to get up from a chair, walk 3 meters, and sit down. The time for the test to be completed is reported in seconds.|After 3 month acclimation period to device||||seconds||Standard Deviation|Mean
2664941|NCT01537211|Secondary|Change in Amputee Mobility Predictor Score From Baseline|The Amputee Mobility Predictor (AMP) instrument is used to asses the functional mobility through a standardized sequence of mobility tests while using the prosthesis. Individual tasks are scored and combined, resulting in a total assessment, which is scored out of 47. The minimum score is zero and maximum score on this scale is 47. Higher scores indicate better mobility.|After 3 month acclimation period to device||||score on a scale||Standard Deviation|Mean
2664942|NCT01537211|Secondary|Change in 10 Meter Walk Test Gait Speed From Baseline|"Measure of self selected walking speed by measuring the time it takes an individual to walk 10 meters. The test is performed using a flying start, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line."|After 3 month acclimation period to device||||meters per second||Standard Deviation|Mean
2664943|NCT01537211|Secondary|Change in 6 Minute Walk Test From Baseline|The 6 Minute Walk Test (6MWT) is an endurance test, which measures the distance a subject can walk indoors on a flat, hard surface over a period of 6 minutes, using assistive devices as necessary. The distance covered during the test is measured with a measuring wheel.|After 3 month acclimation period to device||||Feet||Standard Deviation|Mean
2664944|NCT01537211|Primary|Change in Community Physical Activity as Measured by GPS|The difference in social mobility (as seen by GPS) between the 2 devices will be measured.|baseline, 1 month with mechanical knee, 1 month with microprocessor knee||||Steps per day||Standard Deviation|Mean
2664945|NCT01537198|Primary|Number of Subjects With Adverse Events (AEs), Serious AEs (SAEs), and Adverse Drug Reactions (ADRs)|An AE was defined as any untoward medical occurrence that did not necessarily have a causal relationship with treatment. An SAE was an event that resulted in death, was life-threatening, required or prolonged hospitalization, resulted in congenital anomaly or persistent or significant disability, important medical event requiring medical or surgical intervention to prevent serious outcome, or a spontaneous or elective abortion. AEs considered to be related to Synagis were classified as ADRs. The causality of ADRs were assessed by the investigator as 'Probable,' 'Possible' and 'others (unknown). 'Unexpected' AEs are those that are unlabeled.|From the time of informed consent until 30 days after the final administration of Synagis, an expected average of 6 months from the start of Synagis||||participants|||Number
2664946|NCT01537185|Secondary|Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG|• Determination of a humoral immune response to whole cell antigen as determined by ELISA of sera collected on Day 0, 28, 56, and 84.|28, 56 and 84 days following initial vaccination|only subjects with both baseline and day 84 samples were included in the analysis.|||participants|||Number
2664947|NCT01537185|Primary|Unsolicited Adverse Event Reports|"Safety and Tolerability assessed by cohort and product received measured by:~•Number of unsolicited AEs within four weeks after each vaccination"|within 1 week (0-7 days) following each vaccinations||||participants|||Number
2664948|NCT01537133|Primary|Microbial Community Evenness|Pielou's evenness index is a scaled measure of biodiversity and is equal to the observed Shannon diversity index divided by the maximum possible Shannon diversity index, which would occur if all of the species in the sample were equally abundant. Evenness = D/log(S), where D is the Shannon Diversity index and log(S) is the maximum diversity of the sample.|baseline and after 6 weeks of treatment|Only baseline samples were collected from atopic non-asthmatics and healthy controls. Data was not available for all participants due to insufficient amplification in some samples.|||Pielou’s evenness index||Inter-Quartile Range|Median
2664949|NCT01537133|Primary|Microbial Community Diversity|The Shannon diversity index is a type of entropy measure and is a function of the distribution of the total number of organisms across all of the species. If S is the total number of species in the sample and p_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = −Σ p_i log(p_i).|baseline and after 6 weeks of treatment|Only baseline samples were collected from atopic non-asthmatics and healthy controls. Data was not available for all participants due to insufficient amplification in some samples.|||Shannon Diversity Index||Inter-Quartile Range|Median
2664950|NCT01537133|Primary|Microbial Community Richness|Richness is the total number of different bacterial taxa detected in the sample.|baseline and after 6 weeks of treatment|Only baseline samples were collected from atopic non-asthmatics and healthy controls. Data was not available for all participants due to insufficient amplification in some samples.|||number of bacterial taxa||Inter-Quartile Range|Median
2664951|NCT01537120|Secondary|HbA1C At 12 Weeks|Blood samples were taken after 2 weeks of placebo treatment, and again after 12 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%).|At 2 weeks after Placebo treatment and again at 12 weeks after Vildagliptin treatment|Per-Protocol Population: all participants who complied with the assigned medication during each period of study.|||HbA1c (%)||Standard Deviation|Mean
2664952|NCT01537120|Secondary|Hemoglobin A1C (HbA1C) At 2 Weeks|Blood samples were taken after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment to measure the percentage of glycated hemoglobin, HbA1C. Units are therefore presented as HbA1c (%).|At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment|Per-Protocol Population: all participants who complied with the assigned medication during each period of study.|||HbA1c (%)||Standard Deviation|Mean
2664953|NCT01537120|Primary|24 Hour Weighted Mean Glucose (WMG) At 2 Weeks|The 24 hour WMG was measured after 2 weeks of placebo treatment, and again after 2 weeks of vildagliptin treatment. Glucose was measured over a 24 hour period by having participants wear two continuous glucose monitors (CGM), which produced an average glucose value approximately every 5 minutes. Using these values, the concentration of glucose was calculated from Area Under the Curve 0-24 hours (AUC 0-24hr), and was expressed as 24 hour WMG.|At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment|Per-Protocol Population: all participants who complied with the assigned medication during each period of study.|||mg/dL||Geometric Coefficient of Variation|Geometric Mean
2664983|NCT01536704|Secondary|Apparent Elimination Half-life of Nicotine T(1/2)|T(1/2) was calculated using plasma time-concentration values.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.|||hr||Full Range|Median
2665083|NCT01536405|Primary|Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)||Up to 5 days after vaccination 1|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data|||Percentage of participants|||Number
2664954|NCT01537081|Primary|Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 5|Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.|Day 5|Modified Intent-to-Treat(i.e., all randomized and treated subjects who had a baseline and at least 1 post-baseline set of assessments). Only participants who completed Daily Cough and Phlegm Diary Cards on the morning of Day 5 are included.|||units on a scale||Standard Deviation|Mean
2664955|NCT01537081|Primary|Summary Scores on the SUM8 Daily Cough and Phlegm Diary Card On the Morning of Day 4|Participants completed diary cards twice a day that asked questions about their cough and phlegm status. The Daily Cough and Phlegm Diary Card consisted of eleven questions, eight core questions plus three questions that were answered dependent upon the response to core questions. The SUM8 consisted of the sum of the answers to the eight core questions. Each question was answered on a scale of 0-4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.|Day 4|Modified Intent-To-Treat (i.e., all randomized and treated subjects who had a baseline and at least 1 post-baseline set of assessments). Only participants who completed Daily Cough and Phlegm Diary Cards on the morning of Day 4 are included.|||units on a scale||Standard Deviation|Mean
2664956|NCT01537068|Secondary|Response Rate|Assessment of overall improvement: based on HDRS and Clinical Global Improvement Scale Response Rate is defined as 50% improvement of Hamd24 summary scores from baseline.|12 weeks||||Participants|||Count of Participants
2664957|NCT01537068|Primary|Hamilton Rating Scale for Depression (HDRS24)|HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression|Week 12||||units on a scale||Standard Deviation|Mean
2664958|NCT01537068|Primary|Hamilton Rating Scale for Depression (HDRS24)|HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression|Baseline||||units on a scale||Standard Deviation|Mean
2664959|NCT01537042|Secondary|Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) to the End of the Maintenance Period|"The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm-based scores (based on the US general population) were used for analysis. For the PCS, the lowest and highest possible scores are 1 and 81 (rounded).~The SF-36 domains (subscores) are scored so that a higher score indicates a better health state."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||units on a scale||Standard Deviation|Mean
2664960|NCT01537042|Secondary|Change From Baseline in the Short-Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) to the End of the Maintenance Period|"The SF-36 is a 36 item generic human research quality of life instrument that uses a recall period of 4 weeks. Items are grouped into 8 domains as follows: Physical Functioning (10 items), Role Physical (4 items), Bodily Pain (2 items), General Health (5 items), Vitality (4 items), Social Functioning (2 items), Role Emotional (3 items), Mental Health (5 items), and a further unscaled single item (question 2) for perceived stability or change in health (Health Transition) during the last year. The norm based scores (based on the US general population) were used for analysis. For the MCS, the lowest and highest possible scores are -9 and 82 (rounded).~The SF-36 domains (subscores) are scored so that a higher score indicates a better health state."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||units on a scale||Standard Deviation|Mean
2664961|NCT01537042|Secondary|Change From Baseline in the Restless Legs-Quality of Life (RLS-QoL) Total Score to the End of the Maintenance Period|"The RLS-QoL is a disease-specific questionnaire to evaluate quality of life. It consists of 12 items. A total score will be calculated from all of the 12 items. The overall sum score can be from 0 (highest QoL) to 60 (lowest QoL).~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||scores on a scale||Standard Deviation|Mean
2664962|NCT01537042|Secondary|Change From Baseline in Sleep Efficiency to the End of the Maintenance Period|"Sleep stages and time spent in each sleep stage are determined from Electroencephalogram (EEG) readings. Sleep stage data will be used to calculate sleep efficiency. Sleep efficiency will be presented as percentages. Sleep efficiency is the percentage of time in bed spent asleep.~A postive value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||sleep time/ total time in bed||Standard Deviation|Mean
2664984|NCT01536704|Secondary|Time to Reach Maximum Plasma Nicotine Concentration (Tmax)|Tmax was time at which Cmax of nicotine was reached.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.|||hr||Full Range|Median
2664963|NCT01537042|Secondary|Change From Baseline in the Periodic Limb Movement During Sleep Arousal Index (PLMSAI) to the End of the Maintenance Period|"The Periodic Limb Movement during Sleep Arousal Index (PLMSAI) reflects the influence of the PLM on subject's sleep. Arousal is defined as sudden change in the Electroencephalogram (EEG) activity and the index illustrates to what degree the PLMs contribute to arousal from sleep.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||movement per hour||Standard Deviation|Mean
2664964|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 6 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.~Scale 6 measures the severity of daytime tiredness/ sleepiness on an 11-point scale that ranges between 0 (not at all) to 10 (very severe). The ratings are given by the subjects.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||units on a scale||Standard Deviation|Mean
2664965|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 5 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.~Scale 5 measures the severity of RLS symptoms during the last seven days engaged in activities on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||units on a scale||Standard Deviation|Mean
2664966|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 4 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.~Scale 4 measures the severity of RLS symptoms during the last seven days at rest on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||units on a scale||Standard Deviation|Mean
2664967|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 3 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.~Scale 3 measures the severity of RLS symptoms during the last seven nights on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||units on a scale||Standard Deviation|Mean
2664968|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 2 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.~Scale 2 measures the severity of RLS symptoms during the last 7 nights in the situation of falling asleep. This is measured on an 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||units on a scale||Standard Deviation|Mean
2664969|NCT01537042|Secondary|Change From Baseline in the Restless Legs-6 (RLS-6) Rating Scale 1 to the End of the Maintenance Period|"The RLS-6 consists of six scales of which four scales are designed to assess severity of RLS and two scales cover sleep and daytime tiredness.~Scale 1 measures satisfaction with sleep during the last seven nights on an 11-point scale that ranges between 0 (completely satisfied) to 10 (completely dissatisfied). The ratings are given by the subjects.~A negative value in Change from Baseline indicates an improvement from Baseline."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||units on a scale||Standard Deviation|Mean
2664970|NCT01537042|Secondary|Change From Baseline in Clinical Global Impressions (CGI) Item 1 Score|The CGI Item 1 score measures the severity of illness on a scale that ranges from 0 (Not assessed) to 7 (Among the most extremely ill).|Visit 2 (Baseline); Visit 6 (End of Maintence Period)|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||participants|||Number
2664985|NCT01536704|Secondary|AUC [0-infinity (Inf)]|AUC (0-inf) was evaluated using the trapezoid rule.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.|||ng.hr/mL||Standard Deviation|Mean
2664986|NCT01536704|Primary|Maximum Observed Plasma Concentration [Cmaximum (Max)]|Cmax was depicted from plasma concentration of nicotine.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.|||ng/mL||Standard Deviation|Mean
2664971|NCT01537042|Secondary|Change From Baseline in the International Restless Legs Syndrome Study Group Rating Scale (IRLS) Sum Score to the End of the Maintenance Period|"The IRLS is a subject based scale that consists of 10 items to evaluate the severity of major RLS symptoms and the impact of the disease on subjects' functioning in daytime activities. Each of the 10 items is measured on a scale that ranges from 0 (not present) to 4 (severe). A sum score between 0 (no RLS symptoms present at all) and 40 (maximum severity in all symptoms) across all 10 items will be calculated.~A negative value in Change from Baseline indicates an improvement from Baseline in IRLS."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||units on a scale||Standard Deviation|Mean
2664972|NCT01537042|Secondary|Change From Baseline in the Periodic Limb Movements Index (PLMI) to the End of the Maintenance Period|The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). A negative value in change from Baseline indicates an improvement from Baseline to the end of the Maintenance Period.|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||movement/ hour||Standard Deviation|Mean
2664973|NCT01537042|Primary|Ratio From Baseline to the End of the 2-week Maintenance Period in Periodic Limb Movement Index (PLMI)|"The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG).~The reduction of the PLMI is reflected in terms of the ratio from Baseline to the end of the Maintenance Period and was calculated as [PLMI at end of Maintenance Period (MP)] / [PLMI at Baseline].~A PLMI Ratio <1 indicates an improvement from Baseline to the end of the 2-week MP."|From Baseline over the Up-Titration Period (up to 3 Weeks) to the end of the 2-Week Maintenance Period|Full Analysis Set (FAS), which included all randomized subjects with at least 1 patch applied during the Treatment Period, and had evaluable PSG data at Baseline and at the end of the 2-week Maintenance Period.|||ratio||95% Confidence Interval|Least Squares Mean
2664974|NCT01537029|Primary|Clearance (Cl) for Doxorubicin and Cyclophosphamide|Cyclophosphamide analysis was not possible due to rapid drug degradation|0-48 hours||||L/hr||Full Range|Median
2664975|NCT01536951|Primary|Number of Participants With 1 or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)|The number of participants with treatment-emergent adverse events (TEAEs) or treatment-emergent SAEs considered by the investigator to be related to study drug is reported. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through study completion and 30-day follow-up|Enrolled participants who had at least 1 dose of study drug (LY3009104, moxifloxacin, or placebo) during the study.|||Participants|||Count of Participants
2664976|NCT01536951|Primary|Pharmacokinetics: Area Under the Concentration Curve From Time 0 to Infinity [AUC(0-inf)] of LY3009104||Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug|Randomized participants who received at least 1 dose of LY3009104 and had a predose and at least 1 postdose blood draw for AUC assessment.|||hours*nanomoles per liter (h*nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2664977|NCT01536951|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104||Parts A and B, Periods 1 through 3: Predose and 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after administration of study drug|Randomized participants who received at least 1 dose of LY3009104.|||nanomoles per liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2664978|NCT01536951|Primary|Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using the population-corrected formula: QTcP = QT/RR^beta, where beta is the population correction factor computed from a log-linear model (ln) QT = alpha+beta*ln RR fitted to all Day -1 and Day 1 predose QT and RR measurements in all periods for all participants. Baseline is the average of data collected for 2 hours before dosing on Day 1 of each period [-2 hours (h), -1.5 h, -1 h, -0.5 h, and 0 h]. The QTcP interval was not assessed during Part A of the study, as specified in the protocol. The QTcP interval at 1 h, 2 h, and 4 h postdose for moxifloxacin was compared to placebo to establish assay sensitivity.|Part B, Periods 1 through 3: Baseline, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 12 h, and 24 h postdose|Participants enrolled in Part B of the study who had at least 1 dose of study drug (LY3009104, moxifloxacin, or placebo).|||milliseconds (msec)||Standard Deviation|Mean
2664979|NCT01536938|Primary|Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4.|Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation.|4 weeks||||participants|||Number
2664980|NCT01536886|Primary|Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4.|Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation.|4 weeks||||participants|||Number
2664981|NCT01536860|Primary|Glycemic Response Measured as the Positive Incremental Area Under the Time-concentration Curve(iAUC) Calculated From Individual Glucose Measurements Upon Consumption of Control and Experimental Test Food Products|The individual glucose measurements were collected at baseline (prior to consumption of each test food product and 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of each test food product. The positive incremental area under the time-concentration curve (iAUC) was then calculated for the entire 120 minutes after consumption of each test food product. The results show the differential treatment-related effect on the time-concentration curve (iAUC) for the entire 120 minutes post consumption of each test food product.|0-120 minutes||||mmol*min/L||Standard Error|Mean
2664987|NCT01536704|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Time t [AUC(0-t)]|AUC(0-t) was evaluated using the trapezoid rule.|Blood samples taken pre-dose and post-dose at 3, 5, 10, 15, 20, 30, 40, and 50 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours|Analysis was done per intention to treat (ITT) population.|||nanogram (ng).hour (hr)/millilitre (mL)||Standard Deviation|Mean
2664988|NCT01536587|Secondary|Arterial Stiffness at Baseline (Week 0) and at Week 4|Arterial stiffness occurs as a consequence of age and arteriosclerosis. Carotid-femoral pulse wave velocity (PWV), a measure of arterial stiffness, is determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. PWV was evaluated in terms of meters per second (m/s). PWV after salmeterol inhalation at Baseline (Week 0, [Visit 1, before any inhalation]) and at Week 4 (Visit 2, after inhalation of salmeterol) was assessed.|Baseline and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||m/s||Standard Deviation|Mean
2664989|NCT01536587|Secondary|Number of Participants With Diastolic Dysfunction on Echocardiography at Baseline (Week 0) and at Week 4|Diastolic dysfunction refers to the decline in performance of one (usually the left ventricle) or both (left and right) ventricles during diastole. The number of participants with diastolic dysfunction on echocardiography was evaluated at Baseline (Week 0, [Visit 1, before any inhalation]) and at Week 4 (Visit 2, after salmeterol inhalation).|Baseline and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||participants|||Number
2664990|NCT01536587|Secondary|Lung Function (Forced Vital Capacity [FVC], Functional Residual Capacity [FRC; Body and Helium], Total Lung Capacity [TLC], and Residual Volume [RV]) at Baseline (Week 0) and at Week 4|FVC is defined as the volume of air that can be forcibly blown out from the lungs after a full inspiration. FRC is defined as the volume of air present in the lungs, specifically the parenchyma tissues, at the end of a passive expiration. TLC is defined as the maximum volume to which the lungs can be expanded with the greatest possible inspiratory effort; it is equal to VC plus the RV and is approximately 5800 milliliters. RV is defined as the amount of gas remaining in the lungs at the end of a maximal exhalation. All parameters describing lung function are expressed in terms of liters (L). Lung function (FVC, FRC [body and helium], TLC, and RV) was evaluated at Baseline (Week 0, [Visit 1, before any inhalation]) and at Week 4 (Visit 2, after salmeterol inhalation).|Baseline and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||L||Standard Deviation|Mean
2664991|NCT01536587|Secondary|Change From Baseline in Transcutaneous Carbon Dioxide (tCO2) at 2 Hours (Week 0) and at Week 4|Transcutaneous carbon dioxide monitoring is a noninvasive way of continuously measuring the tension of these gases in the skin. This methodology provides a continuous noninvasive estimation of the arterial CO2 value. Change in tCO2 after salmeterol inhalation is expressed in terms of millimeters of mercury (mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|Safety Population. Only those participants available at the indicated time points were assessed.|||mmHg||Standard Deviation|Mean
2664992|NCT01536587|Secondary|Change From Baseline in Oxygen Saturation Measured Via Pulse Oxymetry (SpO2) at 2 Hours (Week 0) and at Week 4|Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen. The percentage is called blood oxygen saturation, or SpO2. Change in SpO2 after salmeterol inhalation is expressed in terms of percent. Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|Safety Population: all participants included in the study who received at least one dose of study medication. Only those participants available at the indicated time points were assessed.|||percent||Standard Deviation|Mean
2664993|NCT01536587|Secondary|Change From Baseline in Catecholamines (Brain Natriuretic Peptide [BNP]) at 2 Hours (Week 0) and at Week 4|Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (BNP) after salmeterol inhalation is expressed in terms of picograms per milliliter (pg/mL). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||pg/mL||Standard Deviation|Mean
2664994|NCT01536587|Secondary|Change From Baseline in Catecholamines (Plasma Epinephrine) at 2 Hours (Week 0) and at Week 4|Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (plasma epinephrine) after salmeterol inhalation is expressed in terms of nanograms per milliliter (ng/mL). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||ng/mL||Standard Deviation|Mean
2665010|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Absolute High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (absolute HF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms^2). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population|||ms^2||Standard Deviation|Mean
2664995|NCT01536587|Secondary|Change From Baseline in Catecholamines (Plasma Norepinephrine) at 2 Hours (Week 0) and at Week 4|Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (plasma norepinephrine) after salmeterol inhalation is expressed in terms of nanogramms per liter (ng/L). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||ng/L||Standard Deviation|Mean
2664996|NCT01536587|Secondary|Change From Baseline in Respiratory Minute Volume at 2 Hours (Week 0) and at Week 4|Respiratory minute volume is defined as the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute. Change in respiratory minute volume after salmeterol inhalation is expressed in terms of milliliters per minute (mL/min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||mL/min||Standard Deviation|Mean
2664997|NCT01536587|Secondary|Change From Baseline in Tidal Volume at 2 Hours (Week 0) and at Week 4|Tidal volume is defined as the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied (normal value is approximately 500 milliliters or 7 milliliters per kilogram of body weight). Change in tidal volume after salmeterol inhalation is expressed in terms of milliliters (mL). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||mL||Standard Deviation|Mean
2664998|NCT01536587|Secondary|Change From Baseline in Respiratory Rate at 2 Hours (Week 0) and at Week 4|Respiratory rate is defined as the number of breaths taken within a set amount of time (typically within 60 seconds). Change in respiratory rate after salmeterol inhalation is expressed in terms of respiratory rate (breaths) per minute (min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||breaths per minute||Standard Deviation|Mean
2664999|NCT01536587|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at 2 Hours (Week 0) and at Week 4|Systolic and diastolic BP was manually measured. Change in BP after salmeterol inhalation is expressed in terms of millimeters of mercury (mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||mmHg||Standard Deviation|Mean
2665000|NCT01536587|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|Pulmonary function was measured by FEV1, defined as the volume of air that which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change in FEV1 after salmeterol inhalation is expressed in terms of liters (L). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population. Only those participants available at the indicated time points were assessed.|||L||Standard Deviation|Mean
2665001|NCT01536587|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 2 Hours (Week 0) and at Week 4 (ITT Population)|Pulmonary function was measured by FEV1, defined as the volume of air that which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change in FEV1 after salmeterol inhalation is expressed in terms of liters (L). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||L||Standard Deviation|Mean
2665002|NCT01536587|Secondary|Change From Baseline in Spontaneous Baroreflex Sensitivity (BRS) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|BRS is an important characteristic of baroreflex control and is often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Change in BRS after salmeterol inhalation is expressed in terms of milliseconds per millimeters of mercury (ms/mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population. Only those participants available at the indicated time points were assessed.|||ms/mmHg||Standard Deviation|Mean
2665019|NCT01536587|Secondary|Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/Minute) at 2 Hours (Week 0)|Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. The change in MSNA (bursts per minute [bursts/minute]) was calculated as the difference in MSNA change from Baseline to after the inhalation of salmeterol (2 hours, Week 0, Visit 1) minus the MSNA change from Baseline to after the inhalation of placebo (1 hour, Week 0, Visit 1).|Baseline and 2 hours (Week 0)|ITT-MSNA Population|||Bursts/minute||Standard Deviation|Mean
2665003|NCT01536587|Secondary|Change From Baseline in Spontaneous Baroreflex Sensitivity (BRS) at 2 Hours (Week 0) and at Week 4 (ITT Population)|BRS is an important characteristic of baroreflex control and is often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Change in BRS after salmeterol inhalation is expressed in terms of milliseconds per millimeters of mercury (ms/mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||ms/mmHg||Standard Deviation|Mean
2665004|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Heart Rate at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|Heart rate refers to the speed of the heartbeat, specifically the number of heartbeats per unit of time. Change in HRV (heart rate) after salmeterol inhalation is expressed in terms of the heart rate (beats) per minute (heart rate/min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population|||beats per minute (bpm)||Standard Deviation|Mean
2665005|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Heart Rate at 2 Hours (Week 0) and at Week 4 (ITT Population)|Heart rate refers to the speed of the heartbeat, specifically the number of heartbeats per unit of time. Change in HRV (heart rate) after salmeterol inhalation is expressed in terms of the heart rate (beats) per minute (heart rate/min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||beats per minute (bpm)||Standard Deviation|Mean
2665006|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Normalized High Frequency Power (HF) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (normalized HF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of HF power component in proportion to the total power minus the very LF (VLF) component (HF/(Total Power-VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population|||percent change||Standard Deviation|Mean
2665007|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Normalized High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (normalized HF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of HF power component in proportion to the total power minus the very LF (VLF) component (HF/(Total Power-VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||percent change||Standard Deviation|Mean
2665008|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Normalized Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: The LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (normalized LF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of LF power component in proportion to the total power minus the very LF (VLF) component (LF/(Total Power-VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population|||percent change||Standard Deviation|Mean
2665009|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Normalized Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (normalized LF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of LF power component in proportion to the total power minus the very LF (VLF) component (LF/(Total Power-VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||percent change||Standard Deviation|Mean
2665029|NCT01536561|Secondary|Nadir Values for Hemoglobin, a Hematologic Parameter|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population|||G/dL||Full Range|Median
2665011|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Absolute High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (absolute HF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms^2). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||ms^2||Standard Deviation|Mean
2665012|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Absolute Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (N-N) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: The LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (absolute LF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms2). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation), respectively.|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population|||ms^2||Standard Deviation|Mean
2665013|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Absolute Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (absolute LF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms^2). Change from Baseline were calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||ms^2||Standard Deviation|Mean
2665014|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Square Root of the Mean Squared Difference of Successive NNs (RMSSD) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. Compared with SDNN, RMSSD is a short-term variation of heart rate. Change in HRV (RMSSD) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population|||ms||Standard Deviation|Mean
2665015|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Square Root of the Mean Squared Difference of Successive NNs (RMSSD) at 2 Hours (Week 0) and at Week 4 (ITT Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. Compared with SDNN, RMSSD is a short-term variation of heart rate. Change in HRV (RMSSD) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||ms||Standard Deviation|Mean
2665016|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Standard Deviation of NN Intervals (SDNN) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)|HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. SDNN reflects all the cyclic components responsible for variability in the period of recording; therefore, it represents total variability. Change in HRV (SDNN) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT-MSNA Population|||ms||Standard Deviation|Mean
2665017|NCT01536587|Secondary|Change From Baseline in Heart Rate Variability (HRV): Standard Deviation of NN Intervals (SDNN) at 2 Hours (Week 0) and at Week 4 (ITT Population)|Heart rate variability (HRV) refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. SDNN reflects all the cyclic components responsible for variability in the period of recording; therefore, it represents total variability. Change in HRV (SDNN) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline, 2 hours (Week 0), and Week 4|ITT Population. Only those participants available at the indicated time points were assessed.|||ms||Standard Deviation|Mean
2665018|NCT01536587|Secondary|Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/Minute) at Week 4|Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. Change in MSNA is expressed in terms of bursts per minute (bursts/minute). Change from Baseline was calculated as the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline and Week 4|ITT-MSNA Population. Only those participants available at the indicated time points were assessed.|||Bursts/minute||Standard Deviation|Mean
2665067|NCT01536496|Secondary|Deaths Specified as Early Mortality (<6 Hours Post-injury) and Delayed Mortality (6-24 Hours Post-injury).||Within 24 hours post-injury.||||deaths|||Number
2665020|NCT01536587|Secondary|Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/100 Heart Beats) at Week 4|Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. Change in MSNA is expressed in terms of bursts per 100 heart beats (bursts/100 heart beats). Change from Baseline was calculated as the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).|Baseline and Week 4|ITT-MSNA Population. Only those participants available at the indicated time points were assessed.|||Bursts/100 heart beats||Standard Deviation|Mean
2665021|NCT01536587|Primary|Change in Muscle Sympathetic Nerve Activity (MSNA) at 2 Hours (Week 0)|Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. The change in MSNA (bursts per 100 heart beats [bursts/100 heart beats]) was calculated as the difference in MSNA change from Baseline to after the inhalation of salmeterol (2 hours, Week 0, Visit 1) minus the MSNA change from Baseline to after the inhalation of placebo (1 hour, Week 0, Visit 1).|Baseline and 2 hours (Week 0)|ITT-MSNA Population: all participants who received at least one dose of study medication and who had a valid data registration period of the primary endpoint.|||Bursts/100 heart beats||Standard Deviation|Mean
2665022|NCT01536574|Secondary|Mean Change From Baseline in the Gambling Symptom Assessment Scale (G-SAS) Score at Week 24|The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe. Change from Baseline is calculated as the value at Week 24 minus the Baseline value.|Baseline and Week 24|Safety Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method.|||Scores on a scale||Standard Deviation|Mean
2665023|NCT01536574|Secondary|Mean Gambling Symptom Assessment Scale (G-SAS) Score at Week 24|The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe.|Week 24|Safety Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the last observation carried forward (LOCF) method: the last available on-therapy observation for a participant was used to estimate missing data points.|||Scores on a scale||Standard Deviation|Mean
2665024|NCT01536574|Primary|Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase|An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase.|4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)|Safety Population|||Participants|||Number
2665025|NCT01536574|Primary|Number of Participants With the Indicated Adverse Events During the Follow-up Phase|An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase.|4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)|Safety Population|||Participants|||Number
2665026|NCT01536574|Primary|Number of Participants With an Adverse Event During the Follow-up Phase|AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition.|4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)|Safety Population|||Participants|||Number
2665027|NCT01536574|Primary|Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase|An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. The On-Treatment Phase is comprised of the Open-label Treatment Phase and the Down-titration Phase.|From the start of treatment (Baseline) up to Week 25|Safety Population|||Participants|||Number
2665028|NCT01536574|Primary|Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase)|AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition.|From the start of treatment (Baseline) up to Week 25|Safety Population: all participants who received at least one dose of study drug|||Participants|||Number
2665068|NCT01536496|Primary|28 Day In-hospital Mortality||28 days in hospital||||participants|||Number
2665030|NCT01536561|Secondary|Nadir Values for the Hematologic Parameters ANC, Platelets, and WBC Count|Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of WBC that fights against infection. Platelets and WBCs are types of blood cells.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants for which nadir could be calculated were analyzed. Some participants did not have post-baseline data available.|||1000 cells/millimeters cubed (mm^3)||Full Range|Median
2665031|NCT01536561|Secondary|Time to Recovery to Baseline for the Indicated Hematologic Laboratory Parameters|Time to recovery to baseline is the time required for recovery from nadir values to baseline values.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants for which nadir could be calculated were analyzed. Some participants did not have post-baseline data available.|||days||95% Confidence Interval|Median
2665032|NCT01536561|Secondary|Time to Nadir for the Indicated Hematologic Laboratory Parameters|Nadir is defined as the lowest laboratory value recorded following the administration of the study medication.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants for which nadir could be calculated were analyzed. Some participants did not have post-baseline data available.|||days||Full Range|Median
2665033|NCT01536561|Secondary|Number of Participants With the Indicated Type of Infection|An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population|||participants|||Number
2665034|NCT01536561|Secondary|Time to HAMA Positivity From the First Dosimetric Dose (Time From Baseline [Dosimetric Dose] to the First Reported Presence of HAMA)|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants in this study were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I 131 tositumomab. A positive HAMA value indicates that the participant developed human anti-mouse antibodies above the HAMA assay threshold, and a negative HAMA value indicates either the absence or a below threshold level of human anti-mouse antibodies.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Participants who converted to HAMA positivity were analyzed.|||days||Full Range|Median
2665035|NCT01536561|Secondary|Number of Participants Who Developed Human Anti-mouse Antibodies (HAMA Postivitiy) After Receiving Tositumomab|Tositumomab is a murine (mouse) antibody (immunoglobulin) of the IgG2a subclass. Participants in this study were evaluated to determine whether they developed an immune response to study treatment, as evident by human anti-mouse antibodies (HAMA) after administration of tositumomab and iodine I 131 tositumomab. A positive HAMA value indicates that the participant developed human anti-mouse antibodies above the HAMA assay threshold, and a negative HAMA value indicates either the absence or a below threshold level of human anti-mouse antibodies.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants evaluable for HAMA were analyzed.|||participants|||Number
2665036|NCT01536561|Secondary|Volume of Distribution at Steady State (Vss) of I 131 TST for the Indicated Antibody Predose Levels|Vss is defined as the volume of distribution of the drug at steady state.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.|||liters|infusions|Standard Deviation|Mean
2665037|NCT01536561|Secondary|Maximum Blood Concentration (Cmax) of I 131 TST for the Indicated Antibody Predose Levels|Cmax is defined as the maximum observed concentration of the drug in blood.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.|||% Injected Dose per milliliter (%ID/mL)|infusions|Standard Deviation|Mean
2665038|NCT01536561|Secondary|Area Under the Concentration Time Curve (AUC) of I 131 TST for the Indicated Antibody Predose Levels|Area under the concentration-time curve from the end of the infusion extrapolated to infinite time. AUC measures how much drug is in the system over time after infusion. ID, injected dose.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion.|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.|||%ID * hours per milliliter (%ID.hr/mL)|infusions|Standard Deviation|Mean
2665039|NCT01536561|Secondary|Clearance (CL) of I 131 TST for the Indicated Antibody Predose Levels|Clearance is defined as the volume of blood from which drug is removed per unit time and is a measure of the rate at which drug is removed from the body after the dose.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion.|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.|||Milliliters per hour (mL/hr)|infusions|Standard Deviation|Mean
2665040|NCT01536561|Secondary|Half-life: Initial Half-life (t1/2 Alpha) and Terminal Half-life (t1/2 Beta) of I 131 TST for the Antibody Predose Levels of 0 mg, 95 mg, and 475 mg|t1/2 alpha is the estimated initial or alpha phase half-life in a two-compartmental pharmacokinetic model . t1/2 beta is the estimated terminal or beta phase half-life in a two-compartmental pharmacokinetic model; also denoted as t1/2. Half-life measures how long it takes for the concentration of drug in the blood to decrease by half.|Blood samples were collected at the end of the infusion (Study Day 0) and at 0.5, 1, 2, 4, 12, 24, 36, 48, 72, 96, and 120 hours following the end of the infusion.|ITT Exposed Population. The sample size (“n”) in the category titles is the number of infusions (dosing occasions) with parameter results.|||hours (hr)|infusions|Standard Deviation|Mean
2665041|NCT01536561|Secondary|Overall Survival|Overall survival is defined as the time from the treatment start date to the date of death from any cause.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.|||months||95% Confidence Interval|Median
2665042|NCT01536561|Secondary|Time to Progression of Disease or Death|Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants who experienced progression were evaluated.|||months||95% Confidence Interval|Median
2665043|NCT01536561|Secondary|Duration of Response for All Unconfirmed Responders (CR, CCR, or PR) as Assessed by the Investigator|Duration of response is defined as the time from the first documented response until disease progression.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants with unconfirmed response (CR, CCR, or PR) and those who experienced progressive disease were analyzed.|||months||95% Confidence Interval|Median
2665044|NCT01536561|Secondary|Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator|Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.|||participants|||Number
2665045|NCT01536561|Secondary|Number of Participants (Par.) With the Indicated Response as Assessed by the Investigator|Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population. Only those participants evaluable for response were analyzed.|||participants|||Number
2665046|NCT01536561|Secondary|Tumor/Organ Dosimetry at the Indicated Predoses of 475 mg, 95 mg, and 0 mg (Initial Treatment)|The effect of unlabeled TST pre-treatment on targeting of radioactive TST was evaluated. Serial whole body sodium iodide scintillation probe counts were obtained from participants approximately 1 hour after the administration of the dosimetric dose (DD) and then daily for at least 5 days. Initially, participants received either two or three DDs, each of which was preceded by a pre-dose of unlabeled tositumomab (0, 95, or 475 mg) to determine the dose of unlabeled tositumomab that optimized the radiation dose to tumor. The tumor radiation absorbed dose was determined using gamma camera images.|Serial anterior and posterior gamma whole body scans were obtained 1 hour after the administration of the dosimetric dose (on Day 0), and then daily for at least 5 days until Day 7|"ITT Exposed Population. Participants who received unlabelled doses of 0 mg, 95 mg, or 475 mg were analyzed. Of the 59 participants analyzed, 23 received 2 or 3 dosimetric doses (DD); tumor/organ dosimetry was calculated for all 86 DD. The n in the category title reflects the number of DD, which will differ for each target organ."|||cGy/75 cGy TBD|dosimetric doses|Standard Deviation|Mean
2665047|NCT01536561|Primary|Tumor/Organ Dosimetry of TST/I 131 TST for All Predoses (Initial Treatment)|Serial whole body sodium iodide scintillation probe counts were obtained from participants approximately 1 hour after the administration of the dosimetric dose and then daily for at least 5 days. Gamma camera images of participants were used to calculate the amount of radiation that accumulated in the target tumor and normal organs (tumor/organ dosimetry). Spleen volume may vary based on disease status, and volume correction allows for a comparison of spleen dose across participants.|Serial anterior and posterior gamma whole body scans were obtained 1 hour after the administration of the dosimetric dose (on Day 0), and then daily for at least 5 days until Day 7|"ITT Exposed Population. Of the 59 participants analyzed, 23 received 2 or 3 dosimetric doses (DD); tumor/organ dosimetry was calculated for all 86 DD. The n in the category title reflects the number of DD, which will differ for each target organ depending on whether adequate gamma camera images were available for analysis after each of the 86 DD."|||cGy/75 cGy TBD|dosimetric doses|Standard Deviation|Mean
2665079|NCT01536405|Secondary|Percentage of Participants With Measles-like Rash||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data|||Percentage of participants|||Number
2665080|NCT01536405|Secondary|Percentage of Participants With Mumps-like Symptoms||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data|||Percentage of participants|||Number
2665048|NCT01536561|Primary|Maximum Tolerated Dose (MTD) of TST/I 131 TST Evaluated in the Study|Participants who had prior bone marrow transplantation (BMT) initiated TD at 65 cGy TBD, whereas those who had no prior BMT initiated TD at 25 cGy TBD. The MTD was defined as the highest dose level at which 0/3 or 1/6 par. experienced DLT: any Grade 4 hematologic toxicity (National Cancer Institute criteria) lasting >7 days, any Grade 3 hematologic toxicity lasting >2 weeks, or any Grade 3/4 nonhematologic toxicity. Not Applicable (NA) indicates that no par. were re-dosed.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population|||Total body radiation dose in cGy|||Number
2665049|NCT01536561|Primary|Number of Participants During Retreatment Exposed to the Indicated Dose Levels of the TD, Re-dose, and Total Dose (TD + Re-dose)|Retreatment was administered to participants either at the initial TD of TST/I 131 TST or at a reduced dose if a >=Grade 2 toxicity had occurred after initial treatment, until the MTD was achieved. The MTD was defined as the highest dose level at which 0/3 or 1/6 participants experienced DLT: any Grade 4 hematologic toxicity (National Cancer Institute criteria) lasting >7 days, any Grade 3 hematologic toxicity lasting >2 weeks, or any Grade 3/4 nonhematologic toxicity. Not Applicable (NA) indicates that no participants were re-dosed.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|ITT Exposed Population|||participants|||Number
2665050|NCT01536561|Primary|Number of Participants (Par.) During Initial Treatment Exposed to the Indicated Dose Levels of the Therapeutic Dose (TD), Re-dose, and Total Dose (TD + Re-dose)|Par. (groups of 3-6) received the TD at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (par. who had bone marrow transplantation), increasing by 10 cGy increments at each dose level, until the maximum tolerated dose (MTD) was achieved. The MTD was defined as the highest dose level at which 0/3 or 1/6 par. experienced dose-limiting toxicity (DLT): any Grade 4 hematologic toxicity (National Cancer Institute criteria) lasting >7 days, any Grade 3 hematologic toxicity lasting >2 weeks, or any Grade 3/4 nonhematologic toxicity. Not Applicable (NA) indicates that no par. were re-dosed.|Participants who completed at least 2 years of follow-up in Study BEX104728 were invited to enroll in BEX104526 for long-term follow-up. Participants were evaluated in Study BEX104728 and Study BEX104526 for up to 15.6 years.|Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug.|||participants|||Number
2665051|NCT01536535|Secondary|Number of Participants Receiving a Colectomy|Number of participants who received a colectomy within 52 weeks|Within 52 weeks||||Participants|||Count of Participants
2665052|NCT01536535|Primary|Number of Participants Who Needed Additional Therapy or Colectomy|Number of participants who needed additional therapy or colectomy. Additional therapy included Anti-Tumour Necrosis Factor alpha (TNFα), Calcineurin inhibitor, Immunomodulator|Within 52 weeks||||Participants|||Count of Participants
2665053|NCT01536535|Primary|Number of Participants With Corticosteroid Free Remission (SFR)|"Week 52 CS-free remission: Number of participants with a PUCAI < 10 and no corticosteroids (CS) for 28 days without additional therapy or colectomy. Participants in both groups received corticosteroids, biologics, or colectomies, if symptomatic.~The Pediatric Ulcerative Colitis Activity Index (PUCAI) is a non-invasive disease activity index. The index measures include abdominal pain, rectal bleeding, stool consistency, number of stools per 24 hours, nocturnal stools, and activity level. A total score less than 10 indicates remission, Mild disease activity is 10-30, Moderate 35-60, Severe disease activity 65-85."|52 weeks||||Participants|||Count of Participants
2665054|NCT01536496|Secondary|Number of Participants With Multiple Organ Failure (MOF) During This Hospitalization.|Multiple Organ Failure (MOF) score (Denver method) was calculated for the participants. This score rates the dysfunction of four organ systems (pulmonary, renal, hepatic, and cardiac), which are evaluated daily throughout the patient's intensive care unit stay and graded on a scale from 0 to 3, with the total score ranging from 0-12. Higher values on the score represent worse outcome. Participants with score above 3 were considered to have MOF.|Up to 30 days post-injury.||||participants|||Number
2665055|NCT01536496|Secondary|Length of Stay (Days) in the Surgical Intensive Care Unit (SICU) Reported as ICU-free Days and Number of Days on the Ventialator Reported as Ventilator Free Days.||28 days.||||days||Inter-Quartile Range|Median
2665056|NCT01536496|Secondary|Composition and Quantity of Blood Products Transfused at 24 Hours Post-injury|Amount of blood product (red blood cells, plasma, cryoprecipitate and platelets) in units.|24 hours post-injury||||units||Inter-Quartile Range|Median
2665057|NCT01536496|Secondary|Change in r-TEG LY30 Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.||||percent of clot lysis at 30 min.||Inter-Quartile Range|Median
2665058|NCT01536496|Secondary|Change in r-TEG Maximal Amplitude (MA) Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.||||mm||Inter-Quartile Range|Median
2665059|NCT01536496|Secondary|Change in r-TEG Angle Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.||||degrees||Inter-Quartile Range|Median
2665060|NCT01536496|Secondary|Change in r-TEG ACT (Activated Clotting Time) Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.||||seconds||Inter-Quartile Range|Median
2665061|NCT01536496|Secondary|Change in D-dimer Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.||||ug/mL||Inter-Quartile Range|Median
2665062|NCT01536496|Secondary|Change in Platelet Count Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.||||k/uL||Inter-Quartile Range|Median
2665063|NCT01536496|Secondary|Change in Fibrinogen Test Results.||Within first 6 hours post-injury, 12 and 24 hours post-injury.||||mg/dL||Inter-Quartile Range|Median
2665064|NCT01536496|Secondary|Change in INR Test Results.|A high International Normalized Ratio (INR) indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.|Within first 6 hours post-injury, 12 and 24 hours post-injury.||||units on a scale||Inter-Quartile Range|Median
2665065|NCT01536496|Secondary|Time to Death From Injury in Hours.||From time of injury to 28th day of hospitalization.||||hours||Inter-Quartile Range|Median
2665066|NCT01536496|Secondary|Deaths Related to Coagulopathic Bleeding Based Upon Clinical Impressions of the Treating Surgeons and Review of Operative Records and Outcome (Hours Since Injury).||Up to 28 days post-injury.||||deaths|||Number
2665069|NCT01536418|Secondary|Pharmacogenetic Analyses|Sample for the pharmacogenetic analyses was collected during any one of the Treatment Phase visit (Week 2, 4, 6, or 8 ). The pharmacogenetic analyses was planned to perform to investigate the relationship between the genetic markers with the safety and efficacy response to GSK1605786A. These pharmacogenetic analyses was not conducted following the early termination of the study. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data was not collected for this outcome measure.|Post randomization any time during early two weeks|ITT population.||||||
2665070|NCT01536418|Secondary|Pharmacokinetics (PK) of GSK1605786A|The PK analyses was planned to perform to characterize the PK of the study drug GSK1605786A, in the participant population. PK is defined as the concentration of drug in a participant's blood at certain time points after the drug was taken by mouth. PK sampling was to be conducted at week 2, 4, 6 ,8, 10 and week 12 (pre-dose, post-dose 0.5 hour (hr) to 2 hr, 3 to 6 hr, and 6 to 28 hr post-dose. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus the data for this outcome measure was not collected.|Baseline (Screening) and Week 12|The PK population consisted of the participants having received investigational product (i.e., participants in the Safety population) and for whom a sample was obtained and analyzed.||||||
2665071|NCT01536418|Secondary|Change From Baseline in Faecal Calprotectin at Week 12|Stool samples were planned to be collected for the measurement faecal calprotectin level at Baseline (Screening) and Week 12. Baseline is defined as the measurement at Screening (Day -21 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time point minus the value at Baseline. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data for this outcome measure was not collected.|Baseline (Screening) and Week 12|ITT Population.||||||
2665072|NCT01536418|Secondary|Change From Baseline in C-reactive Protein Concentration at Weeks 4, 8, and 12|Blood samples were planned to be collected for the measurement of C-reactive protein at Baseline (Screening) and at Weeks 4, 8, and 12. Baseline is defined as the measurement at Screening (Day -21 to Day -1). Change from Baseline was calculated as the value at the post-Baseline time points (Week 4, week 8 and week 12) minus the value at Baseline respectively. The study was terminated prematurely due to absence of favorable benefit-to-risk profile of GSK1605786A, and thus data for this outcome measure was not collected.|Baseline (Screening) and Weeks 4, 8, and Week 12|ITT Population.||||||
2665073|NCT01536418|Secondary|Percentage of Participants With a Clinical Response at Week 8 and at Both Week 8 and Week 12|"Clinical response, defined as decrease in Crohn's disease activity index (CDAI) score, from Baseline value of >=100 points. Baseline defined as Week 0. CDAI is scoring system measuring disease severity with scores of >=220 to <=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn's disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn's disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using no effect imputation where missing was no response or no change in response (were non-responders). If baseline CDAI, < 100,participant was considered non-responder."|Both Week 8 and Week 12|ITT population|||Percentage of participants|||Number
2665074|NCT01536418|Secondary|Percentage of Participants Achieving Clinical Remission at Week 8, Week 12 and at Both Week 8 and Week 12|"Clinical remission is defined as a CDAI score of <150 points. CDAI is scoring system measuring disease severity with scores of >=220 to <=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn's disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn's disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using no effect imputation where missing was no response or no change in response (were non-responders). If the Baseline value was <150, the participant was not considered to have achieved remission."|Week 8 and Week 12|ITT population|||Percentage of participants|||Number
2665075|NCT01536418|Primary|Percentage of Participants Achieving Clinical Response at Week 12|"Clinical response, defined as decrease in Crohn's disease activity index (CDAI) score, from Baseline value of >=100 points. Baseline defined as Week 0. CDAI is scoring system measuring disease severity with scores of >=220 to <=450 describing moderately-to-severely active population(higher score indicated severe disease). Contains 8 questions related to disease symptoms; soft tools in 7 days (weightage (Wt)as 2; abdominal pain over 7 days Wt= 5; general well being Wt= 7;Crohn's disease symptoms Wt=20; antidiarrhoeal medication used Wt=30; abdominal mass Wt=10; Anemia Wt=10; standard weight with Wt=1.Total CDAI score algorithmically derived from participants-reported above Crohn's disease symptoms and investigator recorded assessments, calculated by Interactive Voice Response System. Missing efficacy data, imputed using no effect imputation where missing was no response or no change in response (were non-responders). If baseline CDAI, < 100,participant was considered non-responder."|At Week 12|The Intent-to-Treat (ITT) population comprised of all participants who have satisfied the eligibility criteria and were assigned with study medication.|||Percentage of participants|||Number
2665076|NCT01536405|Secondary|Percentage of Participants With an Injection-site Adverse Event|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs reported were solicited with a Vaccine Report Card.|Up to 5 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data|||Percentage of participants|||Number
2665077|NCT01536405|Secondary|Percentage of Participants With Varicella-like Rash||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data|||Percentage of participants|||Number
2665078|NCT01536405|Secondary|Percentage of Participants With Rubella-like Rash||Up to 42 days after each vaccination|The population analyzed included participants who received >=1 study vaccination and had follow-up safety data|||Percentage of participants|||Number
2665084|NCT01536405|Primary|Geometric Mean Titer (GMT) of Rubella Virus Antibodies|Sera were tested for rubella virus IgG antibody levels by ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination rubella virus serology results|||IU/mL||95% Confidence Interval|Geometric Mean
2665085|NCT01536405|Primary|Geometric Mean Titer (GMT) of Mumps Virus Antibodies|Sera were tested for mumps virus IgG antibody levels by ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination mumps virus serology results|||Mumps Ab units/mL||95% Confidence Interval|Geometric Mean
2665086|NCT01536405|Primary|Geometric Mean Titer (GMT) of Measles Virus Antibodies|Sera were tested for measles virus IgG antibody levels by ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination measles virus serology results|||mIU/mL||95% Confidence Interval|Geometric Mean
2665087|NCT01536405|Primary|Geometric Mean Titer (GMT) of VZV Antibodies|Sera were tested for VZV IgG antibody levels by gpELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results|||ELISA units/mL||95% Confidence Interval|Geometric Mean
2665088|NCT01536405|Primary|Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)|Sera were tested for rubella virus IgG antibody levels by an ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination rubella serology results|||Percentage of participants||95% Confidence Interval|Number
2665089|NCT01536405|Primary|Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL|Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination mumps virus serology results|||Percentage of participants||95% Confidence Interval|Number
2665090|NCT01536405|Primary|Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL|Sera were tested for measles virus IgG antibody levels by an ELISA|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination measles virus serology results|||Percentage of participants||95% Confidence Interval|Number
2665091|NCT01536405|Primary|Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL|Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)|Six weeks after vaccination 1|The per protocol population included participants who received >=1 dose of study vaccine, were seronegative at baseline and had postvaccination VZV serology results|||Percentage of participants||95% Confidence Interval|Number
2665092|NCT01536379|Secondary|Mean Prednisolone Use at Week 24|Adjusted mean difference (treatment-placebo) for Prednisolone use and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction at Week 24. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments Only those participants available at indicated timepoints were analyzed (represented by n=X, X in the category titles).|Week 24|mITT Population|||mg/day||Standard Error|Least Squares Mean
2665093|NCT01536379|Secondary|Mean eGFR at Week 24 and Week 52|The estimated glomerular filtration rate (eGFR) were calculated by the abbreviated Modification of Diet in Renal Disease (MDRD) equation. Adjusted mean difference(treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction at Week 24 and Week 52. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the indicated time points were analyzed (represented by n= X, X in the category titles).|Week 24 and Week 52|mITT Population|||mL/minute/1.73 square meter (m^2)||Standard Error|Least Squares Mean
2665094|NCT01536379|Secondary|Mean Serum Creatinine at Week 24 and Week 52|Adjusted mean difference for serum creatinine values (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction, at Week 24 and Week 52. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||micromole/L||Standard Error|Least Squares Mean
2665095|NCT01536379|Secondary|Proportion of Participants With Episodes of Acute Rejection at Week 24 and Week 52|The endpoint diagnosis was made by a proven biopsy result. Number of rejections only counted once per participant. The proportion of participants with episodes of acute rejection was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population. Participants analyzed had at least one biopsy.|||Proportion of participants|||Number
2665096|NCT01536379|Secondary|Mean Activated: Regulatory T Cell Ratio at Week 24 and Week 52|Activated: regulatory T cell ratio is Activated T cell CD4+CD25hi CD45RA IL 7Rhi (absolute number)/ Regulatory T cell CD4+CD25hi CD45RA IL 7Rlo (absolute number). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||Ratio||Standard Error|Least Squares Mean
2665128|NCT01536366|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.||||ng.h/mL||Standard Deviation|Mean
2665097|NCT01536379|Secondary|Regulatory T Cell (%CD4) at Week 24 and Week 52|Regulatory T cell (%CD4) = CD4+ CD25hi IL-7Rlo (% of CD4+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||Percentage of Regulatory T cell||Standard Error|Least Squares Mean
2665098|NCT01536379|Secondary|Regulatory T Cell Count at Week 24 and Week 52|Regulatory T cell count is CD4+ CD25hi IL-7Rlo (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||cells/mL||Standard Error|Least Squares Mean
2665099|NCT01536379|Secondary|Activated T Cell Percentage at Week 24 and Week 52|Activated T cell percentage (Codarri)= CD4+ CD25hi CD45RA- IL 7Rhi (% of CD4+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||Percentage of activated T cell||Standard Error|Least Squares Mean
2665100|NCT01536379|Secondary|Activated T Cell Count at Week 24 and Week 52|A T cell is a type of lymphocyte that plays a central role in cell-mediated immunity. Activated T cell count Codarri is CD4+ CD25hi CD45RA- IL 7Rhi (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||cells/mL||Standard Error|Least Squares Mean
2665101|NCT01536379|Secondary|Transitional B Cells Percentage at Week 24 and Week 52|Transitional B cell percentage (Newell) is CD19+CD24b+CD38b+IgD+ (%CD19+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||Percentage of transitional B cells||Standard Error|Least Squares Mean
2665102|NCT01536379|Secondary|Transitional B Cells Count at Week 24 and Week 52|Transitional B cell count (Newell) is CD19+CD24b+CD38b+IgD+ (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||cells/mL||Standard Error|Least Squares Mean
2665103|NCT01536379|Secondary|Activated Memory B Cells Percentage at Week 24 and Week 52|Activated memory B cell-CD95% percentage is CD19+CD27+CD95+ (%CD19/CD27). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||Percentage of activated memory B cells||Standard Error|Least Squares Mean
2665104|NCT01536379|Secondary|Activated Memory B Cells Count at Week 24 and Week 52|Activated memory B cell-CD95% count is CD19+CD27+CD95 conc-cells/mL. Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||cells/mL||Standard Error|Least Squares Mean
2665105|NCT01536379|Secondary|Median Percent Change From Baseline in Memory B Cell Count at Week 24 and Week 52|Memory B cells are B cell sub-type that are formed within germinal centres following primary infection and are important in generating an accelerated and more robust antibody-mediated immune response in the case of re-infection. Memory B cell count included CD20+CD27+ cells/mm^3. Baseline value used in the analysis was of Day 0 (Day of transplant). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Percent change from Baseline in Memory B cell count was calculated as the value at Week 24 and Week 52 minus the value at Baseline multiplied by 100. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Median Difference and 95% confidence interval of difference obtained using the Hodges-Lehmann method.|Baseline, Week 24 and Week 52|mITT Population|||Percent change||Full Range|Median
2665129|NCT01536366|Secondary|Tmax - Time of Occurrence of Cmax||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.||||hours||Full Range|Median
2665130|NCT01536366|Primary|Cmax - Maximum Observed Plasma Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.||||ng/mL||Standard Deviation|Mean
2665106|NCT01536379|Primary|Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 24 and Week 52|Change from Baseline in immunoglobulins IgA, IgG and IgM was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||G/L||Standard Deviation|Mean
2665107|NCT01536379|Primary|Change From Baseline in Clinical Chemistry Parameter- Glomerular Filtration Rate (GFR) at Week 24 and Week 52|Change from Baseline in GFR was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||milliliter (mL)/Minute (min)||Standard Deviation|Mean
2665108|NCT01536379|Primary|Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52|Clinical chemistry parameters included calcium (Ca), carbon dioxide content/bicarbonate (CO2/Bicar), glucose (Gl), potassium (K), sodium (Na), phosphorus inorganic (PhI), urea/blood urine nitrogen (U/BUN). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Millimole (MMOL)/L||Standard Deviation|Mean
2665109|NCT01536379|Primary|Change From Baseline in Clinical Chemistry Parameter- Direct Bilirubin, Total Bilirubin and Creatinine at Week 24 and Week 52|Clinical chemistry parameters included direct bilirubin (DB), total bilirubin (TB) and creatinine (C). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Micromole per Liter (umol/L)||Standard Deviation|Mean
2665110|NCT01536379|Primary|Change From Baseline in Clinical Chemistry Parameter- ALP, ALT, AST at Week 24 and Week 52|Clinical chemistry parameter included alkaline phosphatase (ALP), alanine amino Transferase (ALT) and aspartate amino transferase (AST). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||International Unit (IU)/L||Standard Deviation|Mean
2665111|NCT01536379|Primary|Change From Baseline in Clinical Chemistry Parameter- Albumin at Week 24 and Week 52|Change from Baseline in albumin was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||G/L||Standard Deviation|Mean
2665112|NCT01536379|Primary|Change From Baseline in Haematology Parameter- Red Blood Cell (RBC) at Week 24 and Week 52|Change from Baseline in RBC was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Tera (TI)/L||Standard Deviation|Mean
2665113|NCT01536379|Primary|Change From Baseline in Haematology Parameter- Mean Corposcular Volume (MCV) at Week 24 and Week 52|Change from Baseline in MCV was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Femtoliter (FL)||Standard Deviation|Mean
2665114|NCT01536379|Primary|Change From Baseline in Haematology Parameter- Mean Corposcular Hemoglobin (MCH) at Week 24 and Week 52|Change from Baseline in MCH was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Picogram (pg)||Standard Deviation|Mean
2665115|NCT01536379|Primary|Change From Baseline in the Hematology Parameter- Hematocrit at Week 24 and Week 52|Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Percentage of blood||Standard Deviation|Mean
2665116|NCT01536379|Primary|Change From Baseline in the Haematology Parameter- Hemoglobin at Week 24 and Week 52|Change from Baseline in hemoglobin was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Grams per Liter (G/L)||Standard Deviation|Mean
2665173|NCT01536093|Secondary|Episodes of Culture Positive Sepsis|numbers of documented sepsis events defined as isolation of the microorganism from ≥ 1 blood culture + ≥ 1 clinical symptoms or sign (fever, hypothermia, apnea, bradycardia, hypo-/hyperglycemia)|from date of randomization up to 4 months of age|||||||
2665117|NCT01536379|Primary|Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52|Hematology parameters included: basophils (B), eosinophils (E), lymphocytes (L), monocytes (M), total neutrophils (N), platelet count (PC) and white blood cells (WBC). Change from Baseline in haematology parameter was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Gills/Liter (GI/L)||Standard Deviation|Mean
2665118|NCT01536379|Primary|Number of Participants Outside the Normal Range (NR) for Body Temperature at Week 24 and Week 52|Number of participants outside the normal range (NR) for body temperature was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (<) normal range and greater than (>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||Participants|||Number
2665119|NCT01536379|Primary|Number of Participants Outside the Normal Range (NR) for Heart Rate at Week 24 and Week 52|Number of participants outside the normal range (NR) for heart rate was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (<) normal range and greater than (>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||Participants|||Number
2665120|NCT01536379|Primary|Number of Participants Outside the Normal Range (NR) for SBP and DBP at Week 24 and Week 52|Number of participants outside the normal range (NR) for SBP and DBP was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (<) normal range and greater than (>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Week 24 and Week 52|mITT Population|||Participants|||Number
2665121|NCT01536379|Primary|Change From Baseline in Body Temperature From Baseline at Week 24 and Week 52|Change from Baseline in body temperature was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Degree Centigrade||Standard Deviation|Mean
2665122|NCT01536379|Primary|Change From Baseline in Heart Rate From Baseline at Week 24 and Week 52|Change from Baseline in heart rate was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||Beats per minute (BPM)||Standard Deviation|Mean
2665123|NCT01536379|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24 and Week 52|Change from Baseline in SBP and DBP were assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24 and Week 52|mITT Population|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2665124|NCT01536379|Primary|Number of Incidence of All Infections and Serious Infections|All infections included: 1. Opportunistic infections per-clinical assessment, 2. Herpes Zoster, a. Recurrent, b. Disseminated, 3. Sepsis. Opportunistic infections were identified using list of preferred terms as per Medical Dictionary for Regulatory Activities (MedDRA) version 18.1. Any events falling under these preferred terms were adjudicated to determine if criteria was met for an opportunistic infection.|Up to 1 year|mITT Population|||Infections|||Number
2665125|NCT01536379|Primary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)|Number of participants with AEs, SAEs and AESI are summarized. The On-treatment (OT) phase started on the day and time of receiving the start of the first infusion and ended on the last dose date plus 28 days. The Post-treatment (PT) phase started 29 days after day of last dose up to 1 year. An AE is any untoward medical occurrence, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in, death, is life threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, Is a congenital anomaly/birth defect or event that but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed. AESI included malignant neoplasms, infusion/anaphylaxis/hypersensitivity reactions, all infections, depression/suicide/self-injury, deaths.|Up to 1 year|mITT Population|||Participants|||Number
2665126|NCT01536379|Primary|Change From Baseline in naïve B Cells From Baseline to Week 24|Naive B cell is cell that is not exposed to antigen. Naïve B cell count is CD20+CD27 concentration of cells (conc-cell)/cubic millimeter (cumm). Change from Baseline in naïve B cells was calculated as the value at Week 24 minus the value at Baseline. MITT Population consisted of all participants randomized to treatment, who have had taken at least one dose of study. Participants analyzed included those who had data at Week 24 for naïve B cells count (MITT Population). Baseline value used in the analysis was of Day 0 (Day of transplant). Adjusted mean differences (treatment-placebo) and 95% confidence intervals for differences were obtained from mixed-models repeated-measures (MMRM) model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments.|Baseline and Week 24|Modified Intent to treat (MITT) Population|||cells/mm^3||Standard Error|Least Squares Mean
2665127|NCT01536366|Secondary|AUC0-∞ - Area Under the Plasma Concentration-time Curve From Time 0 to Infinity||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.||||ng.h/mL||Standard Deviation|Mean
2665131|NCT01536262|Secondary|Trough FEV1 Response|"Trough Forced Expiratory Volume in 1 second Response. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements after 52 weeks. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.~Note: The Mean presented is the unadjusted mean."|Baseline and 1 h, 10 min pre-dose after 52 weeks|Full analysis set (FAS)|||L||Standard Error|Mean
2665132|NCT01536262|Secondary|FEV1 AUC0-3h Response|"Forced Expiratory Volume in 1 second Area Under Curve (AUC0-3h) response. FEV1 AUC0-3h was calculated using the trapezoidal rule, divided by the duration (3 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.~Note: The Mean presented is the unadjusted mean."|Baseline and 1 h, 10 min pre-dose and 30 min, 1 h, 2 h, 3 h post-dose after 52 weeks|Full analysis set (FAS): This patient set included all randomised patients who received at least 1 dose of treatment and had both non-missing baseline and at least 1 non-missing post-baseline efficacy measurement. Assignment to FAS was done after implementation of any data handling rules which set measurements to missing.|||L||Standard Error|Mean
2665133|NCT01536262|Primary|Number (%) of Patients With Drug-related AEs|Number (%) of patients with drug-related Adverse Events (AEs).|From first drug administration until 21 days after the last administration, upto 392 days|Treated set: This patient set included all patients who received at least 1 dose of treatment.|||percentage of participants|||Number
2665134|NCT01536197|Secondary|Changes on Emotional, External and Restricted Eating Behavior and Food Craving After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding).|-Eating behavior will be measured with validated questionnaires including among others the Dutch Eating Behavior Questionnaire (DEBQ) and the Food Craving Inventory (FCI). The DEBQ measures three common psychological dimensions of eating behavior: 1) emotional eating , 2) external eating (an inclination to eat in response to external food cues such as the smell and taste of food), and 3) restrained eating (an inclination to consciously restrict food intake to control body weight). The FCI is a validated measure of the frequency of overall food cravings as well as cravings for specific types of foods (high fats, sweets, carbohydrates/ starches, and fast-food fats) during the past month. For the DEBQ and the FCI, subjects score their answers by using a 5-point Likert scale (1=never, 5=very often/always).Therefore, lower numbers means having less frequent food cravings (for FCI), or engaging less frequently in the particular type of eating behavior (for DEBQ).|we will measure the above outcomes before surgery and at 20% weight loss post surgery, which on average we expect will occur around 3 months post-surgery||||units on a scale||Standard Deviation|Mean
2665135|NCT01536197|Primary|Changes on Taste Detection Thresholds After Bariatric Surgery-induced Weight Loss (Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Banding).|-Taste detection thresholds measures the lowest concentration of a tastant that can be detected (mili molar amounts).|we will measure the above outcomes before surgery and at 20% weight loss post surgery, which on average we expect will occur around 3 months post-surgery||||mmol/L||Inter-Quartile Range|Median
2665136|NCT01536184|Secondary|The Strengths and Difficulties Questionnaire SDQ|The Emotional Symptoms (SDQ-ES), Conduct Problems (SDQ-CP), Hyperactivity (SDQ-HA), Peer Problems (SDQ-PP), and Prosocial (SDQ-PS) Scales each range from 0-10 Higher values in (ES, CP, HA, and PP) indicate a greater degree of abnormal behavior; low values indicate more normative behavior. For the PS scale, higher values indicate greater strengths in prosocial behaviour and lower values indicate more difficulties with prosocial behavior. A Total Difficulties Score ranges from 0 to 40 with higher scores reflecting higher levels of behavioral difficulty. The Total Impact Supplement Score (Total IS) ranges from 0 to 10 with higher values indicating greater behavioral difficulty and social impairment.|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)|Please see category specific n values below.|||units on a scale||Full Range|Mean
2665137|NCT01536184|Secondary|The Depression Anxiety Stress Scale (DASS)|"A self-report measure of depression, anxiety, and stress. The scales of the DASS show high internal consistency and produce meaningful discriminations in different settings, and are appropriate for measuring the emotional states of caregivers over time.~The score for each item ranges from 0 to 3, where 0 indicates did not apply to me at all and 3 indicates applied to me very much, or most of the time. The individual items are combined using a scoring template into measures of Depression (D), Anxiety (A), and Stress (S). Depression is scored out of 28 where 0-9 is normal and 10-28 reflect mild, moderate, and severe degrees of depression. Anxiety is scored out of 20 where 0-7 is normal and 8-20 reflect mild, moderate, and severe degrees of anxiety. Stress is scored out of 34 where 0-14 is normal and 15-34 reflect mild, moderate, and severe degrees of stress."|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)|Receives COS Intervention Pretest= 8; Post-test=6; Follow-up=5 Control Group Pretest=4; Post-test=2; Follow-up=2|||units on a scale||Full Range|Mean
2665138|NCT01536184|Secondary|The Parenting Stress Index (PSI)|"A parent-report questionnaire of parental stress reflecting parent-child interaction style and difficult child behaviour. There are two main domain scores, a Child Domain Score and Parent Domain Score from which a Total Stress Score is calculated.~Child and Parent Domain raw scores combine to form a Total Stress raw score. Higher scores for each item indicate a higher degree of negative attributes in the given scale while lower scores indicate lower relationship stress and a greater sense of enjoyment in the relationship.~Items include:~Defensive Responding (DR) Score range 7-35 Parental Distress (PD) Score range 12-60 Parent-Child Dysfunctional Interaction (PCDI) Score range 12-60 Difficult Child (DC) Score range 12-60 PSI Total Stress Score range 36-180"|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)||||units on a scale||Full Range|Mean
2665154|NCT01536145|Secondary|Single Dose Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504, 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the pharmacokinetic (PK) parameters of primary interest.|||milligram•hour/liter (mg•hr/L)||Standard Deviation|Mean
2665155|NCT01536145|Secondary|Single Dose End-of-infusion Concentration (Cinf) for CP-751,871||1 hour postdose in Cycle 1|All participants treated who had at least 1 concentration.|||milligram/liter (mg/L)||Standard Deviation|Mean
2665156|NCT01536145|Primary|Maximum Tolerated Dose (MTD)|The highest dose level at which not more than 1 dose-limiting toxicity (DLT) was observed during Cycle 1 in 6 participants|Baseline up to Cycle 1 (Week 4 or Week 8)|All participants who received at least 1 dose of study drug CP-751,871.|||mg/kg|||Number
2665139|NCT01536184|Secondary|The Parenting Scale (TPS)|"A self-report measure of dysfunctional parenting practices including laxness, over-reactivity, and verbosity. The scale has good internal consistency and test-restest reliability and scores are consistent with other measures of dysfunctional discipline and child misbehaviour.~Each subscale score, ranges from 1 to 7; for each subscale (Laxness, Overreactivity, Verbosity) lower values indicate a lower degree of self-perceived ineffective parenting behaviors and higher values indicate a greater degree of self perceived ineffective parenting behaviours. The total score is calculated from a combination of each subscale and also ranges from 1 to 7, reflecting the degree of ineffective parenting behaviours across all categories with lower values indicate a lower degree of self-perceived ineffective parenting behaviors and higher values indicate a greater degree of self perceived ineffective parenting behaviours."|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)|Number of Participants Analyzed Receives COS Intervention Pretest= 8; Post-test=6; Follow-up=5 Control Group Pretest=4; Post-test=2; Follow-up=2|||units on a scale||Full Range|Mean
2665140|NCT01536184|Primary|Attachment Classification|Attachment classified using Ainsworth's Strange Situation protocol: Secure, Anxious-Insecure, Anxious-Avoidant, Avoidant, Disorganized.|Administered 3 times: at baseline (pretest), 9 months (postest), 12 months (followup)|Number of participants analyzed Receives COS Intervention Pretest= 8; Post-test=3; Follow-up=4 Control Group Pretest=4; Post-test=1; Follow-up=1|||participants|||Number
2665141|NCT01536171|Primary|Metabolic Rate During Barefoot and Shod Running|"This study will measure the metabolic rate when a person runs on the treadmill with shoes (shod) and without shoes.~Each person will run for 20 minutes on the treadmill on two different days, one with and one day without shoes."|Study consists of two visits, approximately 2 hours for each visit||||kilojoules per minute||Standard Deviation|Mean
2665142|NCT01536171|Secondary|Peak Impact Forces During Barefoot and Shod Running|"This study will be measuring the peak impact forces that a runner produces when running on the treadmill with shoes (shod) and without shoes.~Each person will run for 20 minutes on the treadmill on two different days, one with and one day without shoes."|Study consists of two visits, approximately 2 hours for each visit||||Newtons||Standard Deviation|Mean
2665143|NCT01536145|Secondary|Time to Disease Progression|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever came first. Tumor progression was determined from oncologic assessment data (where data met the criteria for progressive disease [PD])|Baseline up to end of treatment|A substantial number of participants were not followed-up prior to disease progression, therefore time to disease progression was not estimated.||||||
2665144|NCT01536145|Secondary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Southwest Oncology Group (SWOG) criteria. CR were those with absence of bone marrow or blood findings of multiple myeloma. PR were those with a 50-74% reduction in the quantitative immunoglobulin, and if present, a 50-89% reduction in the urine M-component (Bence-Jones protein).|Baseline, Day 1 at predose/cycle, end of study (30-60 days post last dose)|All participants who completed a minimum of 1 cycle of treatment were evaluable for response. Participants who developed early progressive disease (regardless of the duration of study treatment) prior to response evaluation were also evaluable for response.|||percentage of participants|||Number
2665145|NCT01536145|Secondary|Human Anti-human Antibody (HAHA) Response to CP-751,871||30 minutes predose in Cycle 1 and subsequent cycles, end of study visit (Days 30 and 60) for dose levels below 0.8 mg/kg; 30 minutes predose in Cycle 1 and last scheduled follow-up visit for dose levels greater than or equal to 0.8 mg/kg|All treated participants with HAHA samples collected at time points when circulating CP-751,871 concentrations were below the lower limit of quantification.||||||Number
2665146|NCT01536145|Secondary|Pharmacodynamic-based Dose|The dose associated with PK exposure that was associated with 80% of the maximal effect based on down-regulation of insulin-like growth factor 1 receptor (IGF-1R) expression|Cycle 1 (Week 4 or Week 8)|Data from analysis of the PK/pharmacodynamic relationship could not permit a reliable estimate of the pharmacodynamic-based dose.||||||
2665147|NCT01536145|Secondary|Multiple Dose Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871||0 hour (predose) in Cycles 2 up to 16|Multiple dose Cmin data were listed for individual subjects, however were not summarized by descriptive statistics.||||||
2665148|NCT01536145|Secondary|Multiple Dose Cinf for CP-751,871||1 hour postdose in Cycles 2 up to 16|Multiple dose Cinf data were listed for individual subjects, however were not summarized by descriptive statistics.||||||
2665149|NCT01536145|Secondary|Single Dose Systemic Clearance (CL) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.|||milliliter/day/kilogram (mL/day/kg)||Standard Deviation|Mean
2665150|NCT01536145|Secondary|Single Dose Volume of Distribution at Steady State (Vss) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.|||mL/kg||Standard Deviation|Mean
2665151|NCT01536145|Secondary|Single Dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.|||mg•hr/L||Standard Deviation|Mean
2665152|NCT01536145|Secondary|Single Dose Plasma Decay Half-life (t1/2) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.|||days||Standard Deviation|Mean
2665153|NCT01536145|Secondary|Single Dose Volume of Distribution (Vz) for CP-751,871||Cycle 1: predose; 1; 24; 48; 72; 168; 336; 504 and 672 and 1008 (for participants with an up to 8-week Cycle 1 only) hours postdose|All participants treated who had at least 1 of the PK parameters of primary interest.|||milliliter/kilogram (mL/kg )||Standard Deviation|Mean
2665172|NCT01536093|Secondary|Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2||from date of randomization up to 4 months of age|||||||
2665174|NCT01536093|Secondary|Total Hospital Admission Duration|days from admission to discharge from NICU|up to 4 months of age|||||||
2665157|NCT01536119|Secondary|Paternal Infant Feeding Attitude|Paternal infant feeding attitude will be assessed using the Iowa Infant Feeding Attitude Scale. This scale consist of 17 items with a five point response range (1-5). The total scores range from 17-85. Negative items were reverse scored. Lower scores indicate a preference for formula feeding, while higher scores indicating a preference for breastfeeding.|6 weeks postpartum|Analysis population included only fathers who completed the scale at 6 weeks postpartum|||units on a scale||Standard Deviation|Mean
2665158|NCT01536119|Secondary|Paternal Breastfeeding Self-Efficacy|"Breastfeeding Self-Efficacy Scale- Short Form will be adapted and used to assess fathers' confidence with assisting their partner with breastfeeding.~This instrument has 14 items, with responses ranging from 1-5. The total scores range from 14-70 with higher scores indicating higher breastfeeding self-efficacy."|6 weeks postpartum|Analysis population included fathers completed the scale and who had infants breastfeeding at 6 weeks postpartum (fathers of infants fed expressed breastmilk were not included).|||units on a scale||Standard Deviation|Mean
2665159|NCT01536119|Secondary|Breastfeeding Support|Breastfeeding support is defined as the appraisal, emotional, informational and instrumental support the mother receives from her partner. This component of coparenting will be measured using the Postpartum Partner Support Scale (PPSS), which is a 24-item self-report instrument. The items are rated on a 4 point scale to produce a summative score ranging from 25-100. Two negative items are reversed scored and the higher scores indicate higher levels of postpartum-specific partner support.|12 weeks|Analysis population included only mothers who completed the scale at 12 weeks postpartum|||units on a scale||Standard Deviation|Mean
2665160|NCT01536119|Secondary|Breastfeeding Support|Breastfeeding support is defined as the appraisal, emotional, informational and instrumental support the mother receives from her partner. This component of coparenting will be measured using the Postpartum Partner Support Scale (PPSS), which is a 24-item self-report instrument. The items are rated on a 4 point scale to produce a summative score ranging from 25-100. Two negative items are reversed scored and the higher scores indicate higher levels of postpartum-specific partner support.|6 weeks|Analysis population included only mothers who completed the scale at 6 weeks postpartum.|||units on a scale||Standard Deviation|Mean
2665161|NCT01536119|Secondary|Coparenting Relationship|Coparenting is the degree to which parents work together to achieve parenting goals. This will be measured using Feinberg, Brown and Kan (2010) Coparenting Relationship Scale (CRS). There are 35 items in total in this tool. There is a 7 point response scale ranging from 0 to 6. Total scores range from 0 - 210. Negative items are reversed. Higher scores indicated positive coparenting.|12 weeks postpartum|Analysis population included only mothers who completed the scale at 12 weeks postpartum.|||units on a scale||Standard Deviation|Mean
2665162|NCT01536119|Secondary|Coparenting Relationship|Coparenting is the degree to which parents work together to achieve parenting goals. This will be measured using Feinberg, Brown and Kan (2010) Coparenting Relationship Scale (CRS) Brief Form. There are 14 items in total in this tool. There is a 7 point response scale ranging from 0 - 6. The total score ranges from 0 - 84. Negative items are reversed and the higher scores indicate positive coparenting.|6 weeks|Analysis population included only mothers who completed the questionnaire at 6 weeks postpartum.|||units on a scale||Standard Deviation|Mean
2665163|NCT01536119|Secondary|Any Breastfeeding|Any breastfeeding was measured by asking the mother what she had fed her infant in the last 24 hours and what she usually feeds her baby. Any breastfeeding indicated the mother was breastfeeding or providing her infant with expressed breastmilk and this included combined feeding with formula. If the mother responded she was only formula feeding this indicated the infant she was not doing any breastfeeding or being fed any breast milk.|12 weeks|Analysis population included only mothers|||participants|||Number
2665164|NCT01536119|Secondary|Any Breastfeeding|Any breastfeeding was measured by asking the mother what she had fed her infant in the last 24 hours and what she usually feeds her baby. Any breastfeeding indicated the mother was breastfeeding or providing her infant with expressed breastmilk and this included combined feeding with formula. If the mother responded she was only formula feeding this indicated the infant she was not doing any breastfeeding or being fed any breast milk.|6 weeks|Analysis population included only mothers|||participants|||Number
2665165|NCT01536119|Secondary|Exclusive Breastfeeding|Exclusive breastfeeding will be determined by asking the mother what she has fed her baby in the last 24 hrs and what she usually feeds her baby. This is consistent with the World Health Organizations definition of exclusive breastfeeding and full breastfeeding described by Labbok and Krasovec (1990). This is defined as no food or liquid other than breast milk given to the infant; however, undiluted drops or syrups consisting of vitamins, minerals supplements or medicines are included (Breastfeeding Committee for Canada, 2006; WHO, 2010).|6 weeks|Analysis population included only mothers|||percentage of participants|||Number
2665166|NCT01536119|Primary|Exclusive Breastfeeding Rate at 12 Weeks Postpartum|Exclusive breastfeeding will be determined by asking the mother what she has fed her baby in the last 24 hrs and what she usually feeds her baby. This is consistent with the World Health Organizations definition of exclusive breastfeeding and full breastfeeding described by Labbok and Krasovec (1990). This is defined as no food or liquid other than breast milk given to the infant; however, undiluted drops or syrups consisting of vitamins, minerals supplements or medicines are included (Breastfeeding Committee for Canada, 2006; WHO, 2010).|12 weeks postpartum|Analysis population included only mothers|||percentage of participants|||Number
2665167|NCT01536093|Secondary|Development of Adverse Effects|"category of adverse effects~general - fever or hypothermia, rash~respiratory & cardiovascular - apnea, tachypnea, desaturation, hypotension, bradycardia, tachycardia~gastrointestinal - abdominal distension, bilious gastric remain, vomiting, bloody stool, necrotizing enterocolitis~renal - oliguria (urine output < 1.0cc/kg/day)~laboratory - hypo-/hyper-natremia, acidosis, hypercarbia"|from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age|||||||
2665168|NCT01536093|Secondary|In-hospital Death||up to 4 months of age|||||||
2665169|NCT01536093|Secondary|Development of Intraventricular Hemorrhage ≥ Grade 3||up to 4 months of age|||||||
2665170|NCT01536093|Secondary|Development of Bronchopulmonary Dysplasia ≥ Moderate||up to 4 months of age|||||||
2665171|NCT01536093|Secondary|Episodes of Pneumonia|numbers of documented pneumonia events those accompanied with increased tracheal secretion, increased ventilatory setting and treated with antibiotics|from date of randomization up to 4 months of age|||||||
2665184|NCT01536067|Secondary|Frequency and Severity of Toxicity as Graded According to the Cancer Therapeutic Evaluation Program (CTEP) Common Toxicity Criteria (CTC) Version 4.0|Maximum grade per participant of any AE.|Every 30 days for 2 months|All treated and eligible patients|||participants|||Number
2665185|NCT01536067|Secondary|Duration of Response||From the observation of a response to the time of disease progression, assessed up to 12 months|Due to the study's early termination and low accrual, data were not collected for this assessment.||||||
2665186|NCT01536067|Secondary|Progression-free Survival||From start of treatment to disease progression or death (regardless of the cause of death), whichever comes first, assessed up to 12 months|Due to the study's early termination and low accrual, data were not collected for this assessment.||||||
2665187|NCT01536067|Secondary|Time to Progression||From start of treatment to disease progression, assessed up to 12 months|Due to the study's early termination and low accrual, data were not collected for this assessment.||||||
2665188|NCT01536067|Secondary|Frequency of PR||Every 28 days|Due to the study's early termination and low accrual, data were not collected for this assessment.||||||
2665189|NCT01536067|Secondary|Frequency of Very Good Partial Response (VGPR)||Every 28 days|Due to the study's early termination and low accrual, data were not collected for this assessment.||||||
2665190|NCT01536067|Secondary|Frequency of Near (n)CR||Every 28 days|Due to the study's early termination and low accrual, data were not collected for this assessment.||||||
2665191|NCT01536067|Secondary|Frequency of Complete Remission (CR)||Every 28 days|||||||
2665192|NCT01536067|Primary|Overall Response Rate (CR + PR + MR) of Ofatumumab in Combination With Bortezomib|Assessed using the Consensus Panel recommendations from the Third International Workshop on Waldenstrom Macroglobulinemia.|Every 28 days|Due to the study's early termination and low accrual, data were not collected for this assessment.||||||
2665193|NCT01536015|Secondary|Change in Score on Parkinson's Disease Questionnaire (PDQ8) From Baseline to the End of 7-week Maintenance Period|The Parkinson's Disease Questionnaire (PDQ-8) is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease. Each single item of the 8-item questionnaire ranges from 0 (never) to 4 (always).|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.||||||
2665194|NCT01536015|Secondary|Change in Score on Fatigue Severity Scale (FSS) From Baseline to the End of 7-week Maintenance Period|"The Fatigue Severity Scale is a 9-item scale measuring the impact of fatigue on everyday functioning (e.g. fatigue interferes with my work, each single item of the scale ranging from 1 (disagree) to 7 (agree)."|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.||||||
2665195|NCT01536015|Secondary|Change in Score on Gastrointestinal Neurodegenerative Scale (GIND) From Baseline to the End of the of the 7-week Maintenance Period|Gastrointestinal Neurodegenerative Scale (GIND) is an 18-item scale measuring gastrointestinal dysfunction with each single item of the scale ranging from 0 (never or not at all) to 5 (very severe).|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.||||||
2665196|NCT01536015|Secondary|"Change in Predictability of Off Time (Using MDS UPDRS Part IV Item 4.5) From Baseline to End of the 7-week Maintenance Period"|The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part IV is a 6-item scale with each single item of the scale ranging from 0 (normal) to 4 (severe).|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.||||||
2665197|NCT01536015|Secondary|"Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III (Motor Examination) in the on State From Baseline to the End of the 7-week Maintenance Period"|The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III is an 18-item scale with each single item of the scale ranging from 0 (normal) to 4 (severe).|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.||||||
2665198|NCT01536015|Primary|"Change in Rotigotine Versus Placebo in the Absolute Time Spent Off From Baseline to the End of the 7-week Maintenance Period"|"Mean number of hours marked off during a 24-hour period."|Baseline to 10 weeks|This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced.||||||
2665199|NCT01535976|Primary|Intraoperative Hypoventilation|Subjects receiving intraoperative ketamine in addition to propofol will demonstrate less hypoventilation during the surgical procedure.|8 hours|The median percentage of the sedation time with TCO2 > 50 mmHg|||% time||95% Confidence Interval|Median
2665200|NCT01535937|Primary|Abstinence|Abstinence is defined as 2 or greater weeks of no cocaine use, as ascertained by the TLFB and urine toxicology.|Abstinence will be assessed over 4 weeks starting at the last day of week 1 and continuing through the end of study at the last day of week 5||||Participants|||Count of Participants
2665201|NCT01535937|Primary|Number of Participants With Cocaine Use/Drop Out|Number of participants who use cocaine and drop from study. During phase 2, patients will be assessed twice weekly by TLFB and urine toxicology for cocaine use. The day of first use will determine the length of time that transpired from discharge to the first lapse onto cocaine.|Over the four week period following discharge from the inpatient unit at Day 5||||Participants|||Count of Participants
2665202|NCT01535807|Secondary|Post Operative Atrial Fibrillation|Post operative rhythm during hospital stay. Rhythm on discharge. Rhythm at cardiac surgery visit. Rhythm within 30 days of surgery.|Within 30 days|||||||
2665203|NCT01535807|Primary|Inflammatory Biomarkers|"The identification of global low molecular weight (LMW) serum proteomic changes associated with CorMatrix ECM treated patients.~Identification of porcine specific LMW and phosphoproteomic serum protein changes associated with CorMatrix ECM treated patients."|Blood and Pericardial Fluid Baseline draw. Pericardial Fluid Post-Op Draw. Blood Post-Op draw Day 1 and Day 3.||||participants|||Number
2665204|NCT01535729|Secondary|Median Overall Survival: Best Response to Prior Chemotherapy|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|Data for best response to prior chemotherapy could not be collected, as it was not recorded in the CRF, hence, the analysis could not be performed.||||||
2665205|NCT01535729|Secondary|Median Overall Survival: Smoking Status|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. Median survival based on the factor of smoking status (smoker, non-smoker and ex-smoker) were reported.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|SAF|||months||95% Confidence Interval|Median
2665206|NCT01535729|Secondary|Median Overall Survival: Gender|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. Median survival based on the factor of gender (male and female) were reported.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|SAF|||months||95% Confidence Interval|Median
2665207|NCT01535729|Secondary|Median Overall Survival: Overall|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|SAF|||months||95% Confidence Interval|Median
2665208|NCT01535729|Secondary|Median Progression Free Survival: Best Response to Prior Chemotherapy|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|Data for best response to prior chemotherapy could not be collected, as it was not recorded in the Case Report Form (CRF), hence, the analysis could not be performed.||||||
2665209|NCT01535729|Secondary|Median Progression Free Survival: Smoking Status|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Median progression-free survival based on the factor of smoking status (smoker, non-smoker and ex-smoker) were reported.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|SAF|||months||95% Confidence Interval|Median
2665210|NCT01535729|Secondary|Median Progression Free Survival: Gender|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Median progression-free survival based on the factor of gender (male and female) were reported.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|SAF|||months||95% Confidence Interval|Median
2665211|NCT01535729|Secondary|Median Progression Free Survival: Age|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression nor death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Median progression-free survival based on the factor of age (65-69, 70-74, 75-79, ≥80 years) were reported.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|SAF|||months||95% Confidence Interval|Median
2665212|NCT01535729|Secondary|Median Progression Free Survival: Overall|Progression-free survival time was defined as the time from the date of first medication to the date of disease progression or death from any cause. If neither progression no death was observed during the study, PFS time was censored at the last day of observation. PD was at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm.|From Baseline then every 3 months from Month 3 until disease progression (Maximum follow-up to Month 40)|SAF|||months||95% Confidence Interval|Median
2665213|NCT01535729|Secondary|Percentage of Participants With Remission of CR and PR|Remission was defined as participants with CR or PR. CR: disappearance of all TLs and non-TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters.|Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
2665214|NCT01535729|Secondary|Time to Start of Erlotinib Therapy After End of First Line Therapy||Baseline|SAF with number of participants evaluable for this outcome measure.|||months||Full Range|Median
2665215|NCT01535729|Secondary|Percentage of Participants With Complete Response (CR), Partial Response (PR) and Stable Disease (SD)|Response rate was observed during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST). It consisted of CR, PR, SD and progressive disease (PD). Participants with CR, PR and SD were reported. CR: disappearance of all target lesions (TLs) and non-TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). PR: at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the baseline (BL) sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that was the smallest on study). In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm.|Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
2665216|NCT01535729|Secondary|Percentage of Participants With Dyspnea by Severity|Severity of dyspnea was categorized as mild, moderate, severe, life-threatening and unknown. Only participants that were included in any of the specified categories in the course of time were reported. Participants with no dyspnea were not included.|Baseline, Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
2665217|NCT01535729|Secondary|Percentage of Participants With Cough by Severity|Severity of cough was categorized as mild, moderate, severe and unknown. Only participants that were included in any of the specified categories in the course of time were reported. Participants with no cough were not included.|Baseline, Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
2665218|NCT01535729|Secondary|Percentage of Participants With Dose Withdrawals by Reason|Reasons for dose withdrawals included progression, participants' wish, intolerance, others and not known. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
2665219|NCT01535729|Secondary|Percentage of Participants With Dose Modifications by Reason|Dose modification included increase or decreased in the dose of the drug and interrupted dose. Reasons for dose modification included progression, participants' wish, intolerance and others. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
2665220|NCT01535729|Secondary|Percentage of Participants With Fatigue Based on Severity During the Course of Time|Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4= life-threatening consequences; urgent intervention indicated. Grade 5= death related to adverse event. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
2665221|NCT01535729|Secondary|Percentage of Participants With Diarrhea Based on Severity During the Course of Time|Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4= life-threatening consequences; urgent intervention indicated. Grade 5= death related to adverse event. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
2665222|NCT01535729|Secondary|Percentage of Participants With Rash Based on Severity During the Course of Time|Severity was categorized as Grades 1, 2, 3, 4 and 5. Grade 1= mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2= moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3= severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4= life-threatening consequences; urgent intervention indicated. Grade 5= death related to adverse event. Only participants that were included in any of the specified categories were reported.|Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
2665223|NCT01535729|Secondary|Percentage of Participants With Diarrhea||Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
2665224|NCT01535729|Secondary|Percentage of Participants With Rash||Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
2665225|NCT01535729|Secondary|Percentage of Participants With Fatigue||Months 3, 6, 9, 12|SAF|||percentage of participants|||Number
2665226|NCT01535729|Secondary|Median Overall Survival: Age|Overall Survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall Survival was analyzed by means of Kaplan-Meier Methods. Median survival based on the factor of age (65-69, 70-74, 75-79, ≥80 years) were reported.|From Baseline then every 3 months from Month 3 until death (Maximum follow-up to Month 40)|SAF|||months||95% Confidence Interval|Median
2665227|NCT01535729|Primary|Percentage of Participants Who Were Alive 1 Year After Start of Treatment|Overall survival was defined as the time from the date of first medication to the date of death from any cause. If death was not observed during the study, survival time was censored at the last day of observation (latest at the end of study after one year). Overall percentage of participants who were alive 1 year after study treatment and those based on the factor of age (65-69, 70-74, 75-79, ≥ 80 years) were reported.|Year 1|SAF|||percentage of participants||95% Confidence Interval|Number
2665238|NCT01535560|Secondary|Median Time (in Days) to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guadian Via the Telephone Diary|Cessation of ear pain was defined as occurring the first time point that ear pain was absent (morning or evening) and did not reoccur in any subsequent diary entries.|Time to event (Day 1 to Day 11)|This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline, minus missing responses.|||Days||Standard Error|Median
2665228|NCT01535664|Primary|Composite Score Overall Balance After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|"The co-primary efficacy variable was overall balance. This novel composite score was created from standardized individual NeuroCom test results (Z-scores).~Overall balance is a weighted average of Sensory Organization Test (SOT) fixed surface eyes open, fixed surface eyes closed, walls moving eyes open, surface moving eyes open, surface moving eyes closed, surface and walls moving eyes open; Limits of Stability Test (LOS) measuring reaction time, movement velocity, endpoint excursion, maximum excursion and directional control; and Adaptation Test (ADT) measuring the averaged, raw sway and center of force during rotational disturbances. ZBAL (Z-Score Balance)= (ZSOT*0.5) + (ZADT*0.2) + (ZLOS*0.3)~Overall balance was calculated by transforming ZBAL into a percentile using the standard normal distribution. This rescales the Z-score to a scale from 0 to 100. A higher score is indicative of better performance."|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population (FAP)|||units on a scale||Standard Deviation|Mean
2665229|NCT01535664|Secondary|Change on the Timed 25 Foot Walk Test (T25FW) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|"The T25FW test is a measure of ambulatory function that provides quantitative data and is used widely in the MS population~A higher walking speed is indicative of better performance"|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population|||Feet per second (ft/s)||Standard Deviation|Mean
2665230|NCT01535664|Secondary|Change on the Two Minute Walk Test (2MWT) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|"Subjects will walk without assistance for 2 minutes and the distance will be measured and timed by the use of a stop watch.~A larger walking distance is indicative of better performance."|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population|||Meters||Standard Deviation|Mean
2665231|NCT01535664|Secondary|Change on the Berg's Balance Scale (BBS) After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|The BBS is a 14-item scale that evaluates subjects ability to sit, stand, reach, maintain single-leg stance, and turn. The scoring is rated from 0 (cannot perform task) to 4 (normal performance of task) for each of 14 items. The maximum possible score is 56 and the lowest 0. A higher total score is indicative of better performance.|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population|||units on a scale||Standard Deviation|Mean
2665232|NCT01535664|Primary|Composite Score Overall Gait After Withdrawal and Reinitiation of Dalfampridine-ER 10mg|"The co-primary efficacy variable was overall gait. This novel composite score was created from standardized individual NeuroCom test results (Z-scores).~ZGAIT (Z-Score Gait) is the average of Walk Across (WA) measuring step width, step length, speed; Tandem Walk (TW) measuring step width, speed and end sway, and Step/Quick turn (SQT) measuring turn time and turn sway).~Overall gait was calculated by transforming ZGAIT into a percentile using the standard normal distribution. This rescales the Z-score to a scale from 0 to 100. A higher score is indicative of better performance."|11 days on drug (day-7 to day 1 + day 11 to day 15) and 10 days withdrawn (day 1 to day 11)|Full Analysis Population (FAP)|||units on a scale||Standard Deviation|Mean
2665233|NCT01535638|Primary|Cmax|Maximum measured concentration of Deleobuvir in plasma. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities.|1:00 h before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 48:00 h after drug administration|The pharmacokinetic set (PKS).|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2665234|NCT01535638|Primary|AUC0-∞|"Area under the concentration-time curve of Deleobuvir in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities."|1:00 (h) hour before drug administration and 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 14:00, 24:00, 48:00 h after drug administration|The pharmacokinetic set (PKS) included all subjects in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK and no vomiting must have occurred at or before two times the median tmax.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2665235|NCT01535599|Secondary|Median Time to Cessation of Ear Pain as Reported by the Patient or Parent/Legal Guardian Via the Telephone Diary|Cessation of ear pain was defined as occurring on the first time point that ear pain was absent (morning or evening) and did not return in any subsequent diary entries. Day 1 was the starting point for this time-to-event analysis. For this analysis, all patients who did not complete the study and ear pain never ceased had their ear pain considered as being present throughout the planned duration of the study.|Time to event, up to Day 11|This analysis population includes the pathogen positive participants of the intent-to-treat (ITT) analysis set, ie, all participants who received study medication and were pathogen positive in the study ear at baseline. Patients who did not report ear pain at any diary entry during first 7 days of the study were excluded from the analysis.|||days||Standard Error|Median
2665236|NCT01535599|Secondary|Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit|Microbiological success was considered attained if all pretherapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. In this analysis, the microbiological success value at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage.|Day 11|This analysis population includes the pathogen positive participants of the intent-to-treat (ITT) analysis set, ie, all participants who received study medication and were pathogen positive in the study ear at baseline.|||percentage of participants|||Number
2665237|NCT01535599|Primary|Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit|An otoscopic exam was conducted by the physician. Clinical cure was considered attained if the sum of the numerical scores of the 3 signs and symptoms of AOE (tenderness, erythema, and edema) was 0 at Day 11. In this analysis, the clinical cure outcome at Day 11 (TOC) was considered a failure for all pathogen positive patients who did not complete the study (for any reason). Proportion of patients is reported as a percentage.|Day 11|This analysis population includes the pathogen positive participants of the intent-to-treat (ITT) analysis set, ie, all participants who received study medication and were pathogen positive in the study ear at baseline.|||percentage of participants|||Number
2665239|NCT01535560|Secondary|Proportion of Patients With Microbiological Successes at the Day 11 (TOC) Visit|Microbiological success was considered attained if all pre-therapy bacteria were absent from the exit otic specimen. The presence of fungi and/or yeast was not considered in the determination of microbiological success. Proportion of patients is reported as a percentage of participants.|Day 11|This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline.|||Percentage of participants|||Number
2665240|NCT01535560|Primary|Proportion of Patients With Clinical Cures at the Day 11 (TOC) Visit|An otoscopic exam was conducted by the physician. Clinical cure was considered attained if the sum of the numerical scores of the 3 signs and symptoms of AOE (tenderness, erythema, and edema) was 0 at Day 11. Proportion of patients is reported as percentage of participants.|Day 11|This reporting group includes the pathogen positive patients of the intent-to-treat (ITT) analysis set, ie. all patients who received study drug and were pathogen positive in the study ear at baseline.|||Percentage of participants|||Number
2665241|NCT01535443|Secondary|Corneal Damage by Lissamine Green Staining Test|Corneal damage will be reported by lissamine green staining using the following scale: absent, mild, moderate, and severe.|10 days|Intention-to-treat analysis (ITT)|||eyes|eyes||Number
2665242|NCT01535443|Secondary|Corneal Damage by Fluorescein Staining Test|Corneal damage will be reported by Fluorescein eye staining using the following scale: absent, mild, moderate, and severe.|10 days|Intention-to-treat analysis (ITT)|||eyes|eyes||Number
2665243|NCT01535443|Secondary|Chemosis|chemosis will be reported according to the following scale: absent, mild, moderate and severe.|10 days|Intention-to-treat analysis (ITT)|||eyes|eyes||Number
2665244|NCT01535443|Secondary|Photophobia|photophobia will be reported according to the following scale: absent, mild, moderate and severe.|10 days|Intention-to-treat analysis (ITT)|||eyes|eyes||Number
2665245|NCT01535443|Secondary|Foreign Body Sensation|Foreign body sensation will be reported according to the following scale: absent, mild, moderate and severe.|10 days|Intention-to-treat analysis (ITT)|||eyes|eyes||Number
2665246|NCT01535443|Secondary|Tearing|Tearing will be reported according to the following scale: absent, mild, moderate and severe.|10 days|Intention-to-treat analysis (ITT)|||eyes|eyes||Number
2665247|NCT01535443|Secondary|Burning|Eye ocular burning will be reported according to the following scale: absent, mild, moderate and severe.|10 days|Intention-to-treat analysis (ITT)|||eyes|eyes||Number
2665248|NCT01535443|Secondary|Hyperemia|The red eye will be evaluated by the absence or presence of hyperemia.|10 days|Intention to treat analysis (ITT)|||eyes|||Number
2665249|NCT01535443|Secondary|Intraocular Pressure (IOP)|Intraocular pressure (IOP) measurement by applanation tonometry. The unit of measurement will be millimeters of mercury (mmhg) the normal range will be considered 11 to 21 mmhg.|10 days|Analyze by intention to treat|||millimeters of mercury (mmhg)||Standard Deviation|Mean
2665250|NCT01535443|Secondary|Findings in Posterior Segment|Abnormal bores will be reported when assessing the integrity of the posterior segment, the unit of measure will be number of findings.|10 days||||abnormal findings|eyes||Number
2665251|NCT01535443|Secondary|Adverse Events|will be reported the presence of adverse events presented in the study group during the intervention period .|10 days|Analysis by intention to treat (ITT)|||events|eyes||Number
2665252|NCT01535443|Primary|Visual Acuity|A Snellen chart is an eye chart that can be used to measure visual acuity. consisting of a scale ranging from 20 to 200, where 20 is the best visual capacity and 200 is the worst|10 days|Per protocol|||units on a scale|eyes|Standard Deviation|Mean
2665253|NCT01535365|Secondary|Request for Rescue Analgesia|Number of participants requesting a rescue analgesic be given|30 minutes||||Participants|||Number
2665254|NCT01535365|Primary|Pain Score After Treatment|Pain measured with validated 100 mm VAS with 0 representing no pain and 100 representing most severe pain imaginable|30 minutes|this sample size gives 80% power to detect a size effect of one SD|||mm||95% Confidence Interval|Mean
2665255|NCT01535326|Other Pre-specified|Post-procedure Discomforts and 30 Day Complication Rate|telephone follow up for post-procedure discomforts and 30 day complication rate|one month|||||||
2665256|NCT01535326|Secondary|Number of Participants With at Least One Adenoma|the number of participants with at least one adenoma in each of the study groups.|9 to 12 months||||participants|||Number
2665257|NCT01535326|Secondary|Patient Satisfaction Score|satisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied|9 to 12 months||||units on a scale||Full Range|Median
2665258|NCT01535326|Secondary|Patient Pain Score|The maximal pain score during insertion phase of colonoscopy was assessed with 0 to 10 scale VAS score (0: no pain; 10: maximal pain)|9 to 12 months||||units on a scale||Full Range|Median
2665259|NCT01535326|Primary|Proportion of Patients Without Pain|proportion of patients without insertion pain during colonoscopy|up to 12 months||||participants|||Number
2665260|NCT01535287|Secondary|Muscle Pain|"Postoperative muscle pain or swelling at the drug injection site. The duration of the stay in the PACU will be retrospectively documented by the research team using EPIC. Data regarding postoperative muscle pain or swelling will be collected by a blinded individual in a telephone interview 3 days after the surgery. Any adverse event will also be documented by the telephone interview. Measurement will be obtained by yes/no by staff based on parent(s) response."|Participants will be followed for the duration immediately following surgery, approximately 30 minutes, through approximately Day 3 post-surgery. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.||||events|||Number
2665269|NCT01535261|Secondary|Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 and Month 24 in the Study Eye|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at month 12 as compared with baseline|Month 12 and Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. No data were excluded from the FAS analyses because of protocol deviations.|||Letters|||Number
2665261|NCT01535287|Secondary|Post-Operative Behavioral Disturbances|"Behavioral disturbances analyzed are: sleep disturbances, anxiety, eating disturbances. These post-operative behavioral disturbances are not considered an adverse event. Data regarding postoperative behavioral disturbances will be collected by a blinded individual in a telephone interview 3 days after the surgery. Any other adverse event (not including serious) will also be documented by the telephone interview. Measurement will be obtained by yes/no to each possible AE by staff based on parent(s) response. Other adverse events (not including serious) reported immediately post-operatively includes: 1. allergic reaction to medication, 2. Respiratory distress, 3. Bronchospasms 4. Laryngospasm, 5. Hemodynamic instability"|Participants will be followed for the duration immediately following surgery, approximately 30 minutes, through approximately Day 3 post-surgery. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.||||events|||Number
2665262|NCT01535287|Secondary|Hemodynamic Instability|"Postoperative adverse hemodynamic events: bradycardia-a decrease in heart rate, hypotension-a decrease in systolic blood pressure (both determined as a 30% decrease from baseline) during PACU duration to discharge. The adverse hemodynamic events will be documented by the anesthesia provider in the operating room and by the recovery room nurses in the PACU recovery room. All will be blinded to the drug administered.Measurement will be obtained by yes/no to each possible adverse respiratory event by anesthesia staff."|Participants will be followed for the duration immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.||||events||Standard Deviation|Mean
2665263|NCT01535287|Secondary|Respiratory Complications Peri-Operative|"Postoperative adverse respiratory events: moderate to severe coughing, oxygen desaturation (SPO2 <90%), breath holding, bronchospasm, aspiration, stridor and/or laryngospasm during PACU duration to discharge. The adverse respiratory events and the adverse hemodynamic events will be documented by the anesthesia provider in the operating room and by the recovery room nurses in the PACU recovery room. All will be blinded to the drug administered. Measurement will be obtained by yes/no to each possible adverse respiratory event by anesthesia staff."|Participants will be followed for the duration immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.||||events||Standard Error|Mean
2665264|NCT01535287|Secondary|Duration of Stay in PACU|Duration of stay in the PACU (Post-Op Area) until discharge criteria are met based on modified PADSS score: level of consciousness, physical activity, hemodynamic stability, respiratory stability, oxygen saturation status, post-operative pain, and post-operative emetic symptoms. Duration of time will be measured in total minutes participate is in PACU until discharged.|Participants will be followed immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia.||||minutes||Standard Deviation|Mean
2665265|NCT01535287|Primary|Participant's Severity of Emergent Agitation (EA) Using the Pediatric Anesthesia Emergence Delirium (PAED) Scale in PACU (Post-Op Area).|"The aim/measurement of the study is to determine whether or not a single IM injection of Dexmedetomidine will reduce the severity of Emergent Agitation (EA) in children undergoing Bilateral Myringotomy with/without tubes under general anesthesia.~We used the only validated scale to assess the severity of post operative emergence delirium in pediatrics. This Pediatric Anesthesia Emergence Delirium (PAED) scale is a composite score of the following items:~Makes eye contact with caregiver.~Child's actions are purposeful.~Child aware of his/her surroundings.~The child is restless.~The child is inconsolable.~Items 1, 2, and 3 are reversed scored as follows: 4-not at all, 3-a little, 2-quite a bit, 1-very much, 0-extremely. Items 4 and 5 are scored as follows: 0-not at all, 1-a little, 2-quite a bit, 3-very much, 4-extremely.~The total score will range from 0 to 20; with 0 indicating no emergence delirium and 20 indicating extreme emergence delirium."|Participants will be followed for the duration of first PACU recovery step, an expected average visit of 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia.||||units on a scale||Standard Deviation|Mean
2665266|NCT01535261|Secondary|Mean Change in Patient-reported Outcomes in NEI-VFQ-25 Composite and Subscale Scores at Month 12 and Month 24 Compared to Baseline|The survey consists of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranges from 0 (worst) to 100 which indicates the best possible response. The composite score and score of each of each construct also range from 0 to 100 as they are calculated as total scores divided by the number of questions. The higher the values of total scores represent better outcome. Scores per visit and of the change descriptively by visit.|Month 12 and Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. The number of patients shown was with a value for both baseline and the post-baseline visit.|||Score on a scale||Standard Deviation|Mean
2665267|NCT01535261|Secondary|Mean Change in Central Reading Center (CRC)-Assessed Central Subfield Thickness (CSFT) From Month 12 and Month 24 Compared to Baseline|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation|Baseline, Month 12 and Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. No data were excluded from the FAS analyses because of protocol deviations.|||Microns||Standard Deviation|Mean
2665268|NCT01535261|Secondary|Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 and Month 24|Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at month 12 and month 24 indicates a positive outcome.|Month 12 and Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. No data were excluded from the FAS analyses because of protocol deviations.|||Letters|||Number
2665270|NCT01535261|Secondary|Mean Average Change in BCVA From First Treatment Interruption (Due to BCVA Stabilization) to Month 12 and Month 24|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. Stability in visual acuity after treatment interruption indicates longer duration of the drug efficacy|Month 12 and Month 24|Full analysis set with use of LOCF consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. The number of patients shown was with a value at treatment interruption and an average for the post treatment interruption visits.|||Letters||Standard Deviation|Mean
2665271|NCT01535261|Secondary|Mean Average Change in Best Corrected Visual Acuity (BCVA From Baseline Month 12 and Month 24|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 12 (or Month 24). Then, mean average change is calculated as the average of average changes across all patients.|Baseline and Month 1 to 12 or Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. One patient was excluded from the FAS for not having ≥ 1 post-baseline study eye VA assessment.|||letters||Standard Deviation|Mean
2665272|NCT01535261|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) at Month 24 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement|Baseline to Month 24|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. One patient was excluded from the FAS for not having ≥ 1 post-baseline study eye VA assessment.|||Letters||Standard Deviation|Mean
2665273|NCT01535261|Primary|Mean Change in Best Corrected Visual Acuity (BCVA) at Month 12 Compared to Baseline|Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement|Baseline to month 12|The Full analysis set (FAS) with use of Last Observation Carried Forward (LOCF) consisted of all patients who received at least 1 administration of study treatment and had at least 1 post-baseline assessment for BCVA in the study eye. One patient was excluded from the FAS for not having ≥ 1 post-baseline study eye VA assessment.|||Letters||Standard Deviation|Mean
2665274|NCT01535235|Secondary|Change in HIV DNA (Copies/Million Rectal Cells)|Change in HIV DNA measured in GALT (gut-associated lymphoid tissue) from baseline|22 weeks|Three participants in the placebo group did not have sufficient cells for analysis for one of the time points.|||copies/million rectal cells||Inter-Quartile Range|Median
2665275|NCT01535235|Primary|Change in HIV RNA (Copies/Million Rectal Cells)|Change in HIV RNA measured in GALT (gut-associated lymphoid tissue) from baseline|22 weeks|Three participants in the placebo group did not have sufficient cells for analysis for one of the time points.|||copies/million rectal cells||Inter-Quartile Range|Median
2665276|NCT01535222|Primary|Incidence of Serious Adverse Events|Number of patients experiencing Serious Adverse Events|7 days (day of surgery to day 7)||||participants|||Number
2665277|NCT01535222|Primary|Incidence of Adverse Events|Number of patients experiencing Adverse Events|7 days (day of surgery to day 7)||||participants|||Number
2665278|NCT01535118|Secondary|Percentage of Participants Who Received Allergy Shots and Had a Co-morbid Condition of Asthma|Participants were asked about co-morbid health conditions. The percentage of participants who had received allergy shots to treat ARC and had asthma was calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey and received allergy shots.|||percentage of participants|||Number
2665279|NCT01535118|Primary|Percentage of Participants Who Received Allergy Shots and Required Supplemental Prescription Allergy Medication|Participants who received subcutaneous immunotherapy (allergy shots) were asked about prescription and over-the-counter medication use. The percentage of participants who received allergy shots to treat ARC, had not taken over-the-counter allergy medication and required supplemental prescription allergy medication for ARC was calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey, received immunotherapy (allergy shots) and had not taken over-the-counter allergy medication.|||percentage of participants|||Number
2665280|NCT01535118|Primary|Percentage of Participants Who Received Immunotherapy to Treat ARC|Participants who had ever received immunotherapy for ARC were asked about the type of immunotherapy - subcutaneous or sublingual - received. The percentage of participants who received immunotherapy to treat ARC was calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey.|||percentage of participants|||Number
2665281|NCT01535118|Primary|Percentage of Participants Who Used Medication to Treat ARC in the Past 12 Months|Participants were asked about prescription and over-the-counter medication use for ARC. The percentages of participants who used prescription and/or over-the-counter medication to treat ARC in the past 12 months were calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey.|||percentage of participants|||Number
2665282|NCT01535118|Primary|Percentage of Participants Who Experienced Work or School Absence Due to ARC in the Past 12 Months|Participants were asked about the impact of ARC on loss of work and school time. The percentage of participants who experienced work or school absence due to ARC in the prior 12 months was calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey.|||percentage of participants|||Number
2665298|NCT01535014|Primary|Average Relative Change in Body Weight After 24 Weeks of Treatment||assessed after 24 weeks of treatment|Intention to treat|||percentage of body weight||Standard Deviation|Mean
2665299|NCT01535014|Primary|Average Body Weight Change After 24 Weeks of Treatment||assessed after 24 weeks of treatment|Intention to treat|||kilogram||Standard Deviation|Mean
2665283|NCT01535118|Primary|Percentage of Participants Who Experienced Daily Symptoms Due to Allergic Rhinoconjunctivitis (ARC)|Participants were asked about the frequency and severity of ARC symptoms when allergies were at their worst. The percentages of participants who experienced different symptoms of ARC on a daily basis when allergies were at their worst were calculated.|Within 12 months prior to survey|The analysis population consisted of all participants who responded to the survey.|||percentage of participants|||Number
2665284|NCT01535053|Secondary|Patient-reported Quality of Life (QOL) After Baseline Visit.|Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements, reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL.|Prior to cycle 3 (4 weeks after cycle 1 if off study treatment prior to cycle 3). Prior to cycle 5, Prior to cycle 7, 26 weeks after starting study treatment.|Provided baseline and ≥1 follow-up assessments|||units on a scale||Standard Error|Least Squares Mean
2665285|NCT01535053|Secondary|Patient-reported Quality of Life (QOL) at Baseline|Patient reported quality of life was measured with the Functional Assessment of Cancer Therapy - Generic (FACT-G). The FACT-G is a scale for assessing general QOL of cancer patients. It consists of four subscales: Physical Well Being, Functional Well Being, Social/Family Well-Being, and Emotional Well-Being. Each item in the FACT-G was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements, reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The FACT-G score is calculated as the sum of the subscale scores. The FACT-G score ranges 0-108. A larger score suggests better QOL.|Prior to cycle 1|Provided baseline QOL questionnaire|||units on a scale||Standard Error|Mean
2665286|NCT01535053|Secondary|The Number of Participants With Post Protocol Multi-agent Chemotherapy Treatment for Each Arm.||Anytime during post treatment follow-up for up to 2 years from study entry.|Non-responding eligible patients in follow-up|||participants|||Number
2665287|NCT01535053|Secondary|The Number of Participants With Post Protocol Surgical Treatment for Each Arm.||Anytime during post treatment follow-up for up to 2 years from study entry.|Non-responding eligible patients in follow-up|||participants|||Number
2665288|NCT01535053|Secondary|Number of Participants With CTCAE v4 Graded Adverse Events With Low-risk Gestational Trophoblastic Neoplasia by Arm|Maximum grade of physician assessed adverse events reported during treatment|Assessed throughout the treatment period and within 2-4 weeks after discontinuation of treatment|Eligible and treated patients|||participants|||Number
2665289|NCT01535053|Primary|Percentage of Participants With Complete Response|Complete Response is defined as 3 consecutive bi-weekly values of hCG<5 over a minimum of 4 weeks of normal hCG values with no values greater than 5 mIU/ml|hCG testing is performed prior to each cycle to treatment until treatment is completed, up to 10 months. For patients who have responded to treatment hCG must be obtained every 4 weeks for 1 year after completing treatment.|Eligible patients|||percentage of participants||95% Confidence Interval|Number
2665290|NCT01535040|Secondary|Smoking Withdrawal|The Wisconsin Smoking Withdrawal Scale is a 28 item questionnaire that assesses nicotine withdrawal. It consists of seven subscales, each consisting of 3-5 questions all answered on a 0-4 scale. Subscale scores are the mean of the items comprising the scale. Some items are reverse scored. Higher scores indicate greater withdrawal symptoms. Subscales were scored if more than half the items were answered. A total score was calculated as the mean of the individual subscales (if more than half the subscales had scores).|12 weeks|Participants who provided data at any time|||units on a scale||Standard Error|Least Squares Mean
2665291|NCT01535040|Secondary|Nicotine Dependence|The Fagerstrom tolerance scale consists of 8 questions, each of which is scored on a 0 to 1 or 0 to 2 scale. The total score ranges from 0 to 11, with higher scores representing greater dependence.|12 weeks|Participants who reported any data|||units on a scale||Standard Error|Least Squares Mean
2665292|NCT01535040|Primary|Adherence|Adherence is the percentage of prescribed pills taken while on therapy.|12 weeks|Participants who returned pill diaries.|||percentage of prescribed pills||Full Range|Mean
2665293|NCT01535040|Primary|Retention|Retention is defined as the percentage of participants who complete the 12 week visit|12 weeks|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2665294|NCT01535014|Secondary|Change in the Quality of Life According to the Data of SF-36 Health Status Survey Questionnaire (SF-36) After 4, 12 and 24 Weeks of Treatment|"36 items of the questionnaire are grouped into eight subscales. The subscales are grouped in two scales: the physical component of health and mental health component. The scores of each scale range between 0 and 100: the higher the score, the better the quality of life and the better the patient's health.~The instruction is not given completely because of the large volume. For more information, see: Ware J.E., Snow K.K., Kosinski M., Gandek B. SF-36 Health Survey. Manual and interpretation guide //The Health Institute, New England Medical Center. Boston, Mass.-1993. In this instruction is explained how eight subscales are combined to compute a total score."|baseline, 4, 12 and 24 weeks|Intention to treat|||scores on a scale||Standard Deviation|Mean
2665295|NCT01535014|Secondary|Waist Hip Ratio After 4, 12 and 24 Weeks of Treatment||assessed after 4,12 and 24 weeks of treatment|Intention to treat|||waist hip ratio||Standard Deviation|Mean
2665296|NCT01535014|Secondary|Average Relative Weight Change After 4, 8, 12, 16, 20 and 24 Weeks of Treatment||assessed after 4, 8, 12, 16, 20 and 24 weeks of treatment|Intention to treat|||percentage of body weight||Standard Deviation|Mean
2665297|NCT01535014|Secondary|Percentage of Subjects With a Decrease in Body Weight by 5 or More Percent of Baseline Body Weight After 4, 8, 12, 16, 20 and 24 Weeks of Treatment||assessed after 4, 8, 12, 16, 20, and 24 weeks of treatment|Intention to treat|||percentage of participants|||Number
2665301|NCT01535001|Other Pre-specified|Exploratory Outcomes|"Pain intensities on a 100 mm VAS with terminal descriptors of 'no pain' and 'worst pain possible' in various situations.~Number of sites with pain in the previous 24 hours shaded on a region-divided body chart~Pain location and type assessed using the Knee Pain Map.~Maximum isometric muscle strength measured bilaterally in knee flexion and knee extension in a make test using a handheld dynamometer (Powertrack II TM Commander).~Pressure pain thresholds measured bilaterally using a handheld algometer (Algometer Type II) at five sites at the knee and the m. tibialis anterior muscle and the m. extensor carpi radialis longus.~Postural balance assessed using an instrumented force platform (Good Balance), measuring the centre of pressure excursion.~Self-efficacy in improving pain, function and QOL in various situations using a 100 mm VAS with terminal descriptors of 'very unsure' and 'very sure'."|Baseline, 3months, 6months, 12months and 24months|Since this is exploratory outcomes they will be analyzed in future publications.||||||
2665302|NCT01535001|Secondary|Change From Baseline in Time From the Timed Up and Go||Primary: 12 months.||||sec||95% Confidence Interval|Mean
2665303|NCT01535001|Secondary|Number of Serious Adverse Events Reported at Index Knee|Adverse events (AE) and seriously adverse events (SAE) will be registered in three ways and divided into index knee or sites other than index knee. The project physiotherapist will record any adverse events that the participant experiences or tells them about. For the participants allocated to, or crossing over to, TKA, a project worker will look through hospital records to register if any pre-defined perioperative and postoperative adverse events occurred. At all follow-ups, the assessor will use open-probe questioning to assess adverse events in all participants.|Primary: 12months.||||Serious adverse events related to knee|||Number
2665304|NCT01535001|Secondary|Proportion of Users of Pain Medication|With possible answers being yes and no|Baseline and 12months.||||proportion of participants||95% Confidence Interval|Number
2665305|NCT01535001|Secondary|Weight Change in kg From Baseline|Weight change in kg measured without shoes at the same time of day and on the same scale|Primary: 12months.|Only patients with a BMI equal to or >25 were included in this analysis.|||kg||95% Confidence Interval|Mean
2665306|NCT01535001|Secondary|Change in the Five KOOS Subscale Scores From Baseline|Range of all subscales are 0 to 100 (worst to best).|Primary: 12 months.||||units on a scale||95% Confidence Interval|Number
2665307|NCT01535001|Secondary|Change From Baseline in 20-meter Walk||Primary: 12months.||||sec||95% Confidence Interval|Mean
2665308|NCT01535001|Secondary|Change From Baseline in EQ-5D|"Between groups comparisons of the change from baseline to the 1 year follow-up in all secondary endpoint will be handled similar to the primary endpoint. See statistical analysis plan for further description (available under Links).~Range of EQ-5D Descriptive Index is -0.59 to 1.00 (worst to best), while the EQ VAS goes from 0 to 100 (worst to best)."|Primary: 12months.||||units on a scale||95% Confidence Interval|Mean
2665309|NCT01535001|Primary|Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score)|"The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best).~Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority."|Primary: 12months.||||units on a scale||95% Confidence Interval|Mean
2665310|NCT01534975|Primary|Image Quality of the CT Scans Using Different Contrast Agents|Attenuation (HU) in the ascending aorta, standard deviation (SD) of aorta, will be measured,.|1 year||||hounsfield units||Standard Deviation|Mean
2665311|NCT01534962|Secondary|Number of Patients in Sinus Rhythm 48 Hours After Cardioversion With Documented AF Recurrence|Documented AF recurrences in those patients who did not experience early relapses (within 48 hours after cardioversion)|16 weeks (112 days)|Modified Intention-to-Treat Population (N=217) excluding 21 patients with AF relapse within 48 hours post cardioversion|||participants|||Number
2665312|NCT01534962|Secondary|Time From Randomization to First Documented AF Recurrence in Patients With Sinus Rhythm 48 Hours After Cardioversion|Excluding patients with early relapses (within 48 hours) while the study drug, started after cardioversion, had not yet reached steady-state.|16 weeks (112 days)|Modified Intention-to-Treat Population (N=217) excluding 21 patients with AF relapse within 48 hours post cardioversion|||Days||95% Confidence Interval|Median
2665313|NCT01534962|Secondary|Number of Patients With Documented and Confirmed AF Recurrences||16 weeks (112 days)|Intention-to-Treat|||participants|||Number
2665314|NCT01534962|Secondary|Time From Randomization to First Documented and Confirmed AF Recurrence|A confirmed AF recurrence was defined as a documented AF recurrence which was confirmed by a consecutive ECG performed at least 1 hour after first AF documentation.|16 weeks (112 days)|Intention-to-Treat (N=238)|||Days||95% Confidence Interval|Median
2665315|NCT01534962|Secondary|Number of Patients With Documented AF Recurrences||16 weeks (112 days)|Intention-to-Treat (N=238)|||participants|||Number
2665316|NCT01534962|Primary|Time From Randomization to First Documented AF Recurrence.|"Time to first AF recurrence reported by patient-reported TT-ECG or 12-Lead ECG at the study site, whichever occurred first.~Patients discontinuing the study without AF were censored at the time of the last available ECG."|16 weeks (112 days)|Intention-to-treat-approach that analyzed all randomised patients who took at least one dose of study medication (N=238, i.e. excluding 3 randomized patients).|||Days||95% Confidence Interval|Median
2665317|NCT01534910|Secondary|Coronary Calcium|Agatston score is a semi-automated tool to calculate a score based on the extent of coronary artery calcification detected by an unenhanced low-dose CT scan. The calculation is based on the weighted density score given to the highest attenuation value (HU) multiplied by area of the calcification speck. The grading of coronary artery disease (based on total calcium score) is as follows: no evidence of CAD: 0 calcium score, minimal: 1-10, mild: 11-100, moderate: 101-400, and severe: >400|1 year|patients undergoing two calcium scores|||agatston units||95% Confidence Interval|Mean
2665640|NCT01531374|Secondary|Cardiovascular Deaths and Valve-Related Deaths||30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
2665318|NCT01534910|Primary|CT Angiography Plaque|"we will measure low attenuation plaque at baseline (in volume) and then again at 1 year. we will assess if there is a reduction in low attenuation plaque volume (percent change from baseline), defined as [followup-baseline]/baseline x100%.~Baseline was time zero, followup CT scan was 1 year."|baseline to 1 year||||percent change of low attenuation plaque||Standard Deviation|Mean
2665319|NCT01534897|Secondary|Clinical Benefit as Measured by Change in Thyroglobulin Level|To evaluate clinical benefit as measured by change in serum tumor marker, thyroglobulin. Rising thyroglobulin is generally indicative of tumor growth.|3 months after radioiodine therapy||||Participants|||Count of Participants
2665320|NCT01534897|Secondary|Number of Participants Who Complete the Study With Minimal Delays and no Dose Reductions|To determine the feasibility of: (a) administering GSK2118436 for 28 days in patients with BRAF V600E-mutant PTC, prior to whole body iodine scanning (all patients); and (b) administering GSK2118436 for an additional 14 days, prior to administering treatment doses of radioactive iodine (patients whose tumors demonstrate significant iodine uptake after 28 days of treatment).|2 years||||Participants|||Count of Participants
2665321|NCT01534897|Secondary|Clinical Benefit as Measured by Change in Tumor Size|To evaluate clinical benefit as measured by objective response rate per modified RECIST 1.1, which assesses changes in size of measurable tumors. (per RECIST, a partial response (PR) = at least 30% decrease in size of tumor; progressive disease (PD) = at least 20% increase in size of tumor; stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD).|2 years||||Participants|||Count of Participants
2665322|NCT01534897|Secondary|Safety Analysis as Number of Participants With Adverse Events|To evaluate the safety and tolerability, as determined by adverse event and serious adverse event reporting, of GSK2118436 in combination with whole body iodine scans (all patients) and treatment doses of radioactive iodine (patients whose tumors demonstrate significant iodine uptake).|2 years|All patients completed dabrafenib without dose modification.|||Participants|||Count of Participants
2665323|NCT01534897|Primary|Increased Radioiodine Uptake|Number of patients with radioiodine-refractory metastatic BRAF V600E-mutant PTC who have increased radioiodine uptake in their disease sites while on dabrafenib. Radioiodine uptake is assessed by whole body scan and areas of interest are identified by nuclear medicine physicians.|25 days after start of Dabrafenib (GSK2118436)||||Participants|||Count of Participants
2665324|NCT01534689|Secondary|Change in Percent (%) of mm Clear Nail|Millimeter (mm) of clear nail from the base of the lunula was measured from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there.|12 weeks||||percentage of change in mm clear nail||Standard Deviation|Mean
2665325|NCT01534689|Secondary|Change in Millimeter (mm) of Clear Nail Bed|Millimeter (mm) of clear nail from the base of the toenail lunula was determined from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. An increase in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has improved and is positive for study success. A decrease in mm of clear nail between the two measurement points indicates that the toenail onychomycosis has worsened and is negative for study success.|12 weeks||||millilmeters||Standard Deviation|Mean
2665326|NCT01534689|Primary|Proportion of Toenails Attaining 25 Percent (%) or More Increase in Clear Nail|"Millimeter (mm) of clear nail from the base of the lunula was measured from digital photographs of the toenail using a computer program. Change in mm of clear nail bed was calculated as the difference in mm of clear nail bed from baseline measurement to the measurement at 3 months post-procedure administration. The percent (%) of increase in clear nail from baseline was calculated from there. An increase in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has improved and is positive for study success. A decrease in mm or percent of clear nail between the two measurement points indicates the toenail onychomycosis has worsened and is negative for study success.~Individual toenail success criteria was defined as 25 percent (%) or more increase in clear nail growth at 3 months post-procedure relative to baseline. Overall study success criteria was defined as 60% or more of treated toenails meeting the individual success criteria."|12 weeks||||percentage of toenails|||Number
2665327|NCT01534676|Primary|Non-transferrin-bound Iron Level||2 hours after transfusion|Enrolled participants (recipients) were never randomized or received transfusion on study because study closed due to poor enrollment. No data was collected or analyzed.||||||
2665328|NCT01534637|Secondary|Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Taking Anti Nausea Drugs||Week 5||||participants|||Number
2665329|NCT01534637|Secondary|Impact of Aprepitant/5HT-3 Antagonist Therapy on the Patient Quality of Life as Measured by the Number of Patients Using Anti Nausea Drugs||Week 1||||participants|||Number
2665330|NCT01534637|Primary|Number of Patients With Gastrointestinal Toxicities (Grade 3 and 4 Nausea and Vomiting) Associated With Delivering Fluorouracil/Gemcitabine Hydrochloride-based Chemotherapy With Upper Abdominal Radiation|Toxicity will be determined using the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0 for Toxicity and Adverse Event Reporting. Descriptive statistics (means, standard deviations, frequencies, etc.) will be presented for pretreatment patient characteristics. The rate of grade 3 and 4 nausea will be compared to the cut points during interim and final analyses.|Over 10 weeks||||participants|||Number
2665331|NCT01534533|Secondary|Dietary Intake of Vitamin C,Vitamin E, Lutein Plus Zeaxanthin and Lycopene During the Study Periods|Dietary intake of Vitamin C,Vitamin E, Lutein plus zeaxanthin and Lycopene was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.|at baseline and 12 months||3333-12-31|12/3333||||
2665332|NCT01534533|Secondary|Dietary Intake of Energy During the Study Periods|Dietary intake was assessed at baseline and after 12months by using 3 consecutive 24-hour recalls.|at baseline and 12 months||3333-12-31|12/3333||||
2665333|NCT01534533|Secondary|Changes of Right Common Carotid Arterial Stiffness Parameter β(R-β) at Baseline and After 12 Months|Arterial stiffness was measured by using a high-resolution B-mode carotid ultrasound with echo-tracking system (Aloka prosound α-10, Aloka Co. Ltd., Tokyo, Japan).|at baseline and after 12 months||3333-12-31|12/3333||||
2665334|NCT01534533|Primary|Table 1 Study Specific Characteristic of Serum Carotenoids|serum major carotenoids, including lutein, zeaxanthin, beta-carotene, and lycopene concentration were measured by hyper-pressure liquid chromatography (HPLC)|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.|||μg/ml||Standard Deviation|Mean
2665335|NCT01534533|Primary|Table 1 Study Specific Characteristic of Blood Pressure (BP)|systolic BP and diastolic BP in four groups was measure twice between 15minutes|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.|||mm Hg||Standard Deviation|Mean
2665336|NCT01534533|Primary|Table 1 Study Specific Characteristic of Body Mass Index (BMI)|the mean and standard deviation of BMI in four groups was calculated|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.|||Kg/m^2||Standard Deviation|Mean
2665337|NCT01534533|Primary|Table 1 Study Specific Characteristic of Age|the mean and standard deviation of age was calculated in four groups|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.|||years||Standard Deviation|Mean
2665338|NCT01534533|Primary|Table 1 Study Specific Characteristic Part One|The percentage of female, race, hypertenion history, diabetes history, and hyperlipemia history was calculated.|at baseline|We conducted a per protocol analysis of all the subjects who completed the study.|||Percentage of Participants|||Number
2665339|NCT01534520|Secondary|Need for Pain Medication up to 7 Days|Number of women taking pain medication for at least one day following IUD insertion|7 days post-insertion||||participants|||Number
2665340|NCT01534520|Secondary|Percentage of IUDs Considered by Physicians Easy to Insert|"The physician who conducted the study visit and IUD insertion was asked about the difficulty/ease in placing the IUD immediately following the procedure and the percentage of IUD insertions considered to be easy was calculated for each study group."|Directly after IUD insertion|Participants in each group self-administered the study gel as per instruction followed by insertion of the IUD by the physician 5 to 15 minutes later.|||percentage of insertions declared easy||95% Confidence Interval|Number
2665341|NCT01534520|Secondary|To Evaluate Patient Experience of Self-inserting the Intravaginal Study Gel Prior to IUD|"Number of participants who rated self-application of study gel as some what easy or very easy on Likert scale"|After inserting the gel but prior to IUD insertion||||participants who found gel easy to use|||Number
2665342|NCT01534520|Primary|Change in Pain From Baseline to IUD Insertion|To assess change in pain from baseline to IUD insertion measured on a visual analog scale (VAS) from 0 mm (no pain) to 100 mm (worst pain in patient's life). This pain assessment was prior to (baseline) and at the time of IUD insertion following vaginal self-administration of study gel (either 2% lidocaine gel or placebo gel).|change in pain score from baseline (before IUD insertion) to time of IUD insertion||||change in visual analog scale score||Inter-Quartile Range|Median
2665343|NCT01534416|Secondary|Postoperative Day Pain Medication Use|Numbers of Patients Using Pain Medication on Postoperative Days 1-10. The subjects recorded at home the type and amount of pain medication they use for 10 days postoperatively.|Postoperative days 0-10|missing data from 5 participants in Bupivacaine Arm and 4 in Saline Arm|||participants|||Number
2665344|NCT01534416|Secondary|Postoperative Pain Score|Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff. On postoperative days 1 and 2 the subjects self-reported their pain level.|1, 2, 4 hour postoperatively, Day 1 post operatively, Day 2 postoperative|Only those subjects with pain analyzed|||units on a scale||Standard Deviation|Mean
2665345|NCT01534416|Secondary|Postoperative Pain Score|Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff.|1and 2 hour postoperatively|This doesn't include hospitalization for reasons other than pain management.|||units on a scale||Standard Deviation|Mean
2665346|NCT01534416|Primary|Number of Participants With Hospital Admission for Postoperative Pain Control|Unplanned hospital admissions and the hospital admissions at the request of the patients for pain management|Four hours after conclusion of surgery||||Participants|||Count of Participants
2665347|NCT01534351|Primary|Number of Participants Who Discontinued Treatment Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 52 weeks|All Participants as Treated (APaT) - population consists of all randomized participants who received at least one dose of study treatment. As only one participant was randomized in the study, no analyses were performed.|||Participants|||Number
2665348|NCT01534351|Primary|Number of Participants Who Experienced an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product.|Up to 54 weeks||||Participants|||Number
2665349|NCT01534351|Primary|Percent Change From Baseline in Prostate Volume|Prostate volume was assessed by trans-rectal ultrasound (TRUS).|Baseline and Month 12|Full Analysis Set (FAS) - population consists of all randomized participants who received at least one dose of study treatment, at least one post-randomization observation for the analysis endpoint, and baseline data for those analyses that require baseline data. As only one participant was randomized in the study, no analyses were performed.||||||
2665368|NCT01534195|Secondary|Ciliary Redness Change From Baseline to Day 6|Ciliary redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (least redness), and 4 was worst (most redness).|7 minutes post-CAC|All participants who completed the study|||score on a scale||Standard Deviation|Mean
2665369|NCT01534195|Secondary|Episcleral Redness Change From Baseline to Day 6|Episcleral redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC.0 was best (least redness), and 4 was worst (most redness).|7 minutes post-CAC|All participants who completed the study|||score on a scale||Standard Deviation|Mean
2665370|NCT01534195|Secondary|Conjunctival Redness Change From Baseline to Day 11|Conjunctival Redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (no redness), and 4 was worst (most redness)|7 Minutes post-CAC|All participants who completed the study|||score on a scale||Standard Deviation|Mean
2665350|NCT01534351|Primary|Change From Baseline in International Prostate Symptom Score (IPSS)|The IPSS is a self-administered questionnaire used to measure the severity of lower urinary tract symptoms among men suspected of having symptomatic Benign Prostatic Hyperplasia (BPH). The IPSS consists of 8 questions (7 urinary symptom questions + 1 quality of life question). The 7 symptom questions inquire about frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying and urgency. Each of the 7 questions has an ordered categorical response frame scored from 0 (not at all) to 5 (almost all the time). The total score is the sum of the 7 items and therefore has a range of 0 to 35. Higher scores indicate higher symptom severity. The quality of life question is a single global question rated on a scale of 0 (delighted) to 6 (terrible) asking the participant to rate how they feel about their current urinary symptom status. The IPSS-QoL question is not used in the calculation of the total symptom score.|Baseline and Month 12|Full Analysis Set (FAS) - population consists of all randomized participants who received at least one dose of study treatment, at least one post-randomization observation for the analysis endpoint, and baseline data for those analyses that require baseline data. As only one participant was randomized in the study, no analyses were performed.||||||
2665351|NCT01534273|Secondary|Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid 1-40 Concentration at 24 Hours Post-dose|LS mean percent changes from baseline to 24 hours post-dose in CSF amyloid 1-40 concentrations for participants in Cohort C are reported. LS means were calculated from an ANCOVA with treatment group and predose CSF amyloid 1-40 concentration as fixed effects. The 95% CI of the percent change from baseline was computed by back-transforming the mean difference between endpoint and baseline.|Baseline, 24 hours post-dose|All randomized participants in Cohort C who received placebo or LY2886721 and had measurable CSF amyloid 1-40 concentration data.|||Percent change||95% Confidence Interval|Least Squares Mean
2665352|NCT01534273|Secondary|Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid 1-40 Concentration at Day 15|Least squares (LS) mean percent changes from baseline to Day 15 in CSF amyloid 1-40 concentrations for participants in Cohort B are reported. LS means were calculated from an analysis of covariance (ANCOVA) with treatment group and predose CSF amyloid 1-40 concentration as fixed effects. The 95% confidence interval (CI) of the percent change from baseline was computed by back-transforming the mean difference between endpoint and baseline.|Baseline, Day 15|All randomized participants in Cohort B who received multiple doses of placebo or 70 mg LY2886721 and had evaluable CSF amyloid 1-40 concentrations.|||Percent change||95% Confidence Interval|Least Squares Mean
2665353|NCT01534273|Secondary|Pharmacokinetics: Plasma Area Under the Concentration Versus Time Curve (AUC) of LY2886721|AUC over the dosing interval at steady state (AUCtau,ss) is reported for participants who received multiple doses of LY2886721.|Day 14 predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose|All randomized participants who received LY2886721 and had evaluable steady-state plasma LY2886721 concentration data.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2665354|NCT01534273|Secondary|Pharmacokinetics: Plasma Maximum Observed Concentration at Steady State (Cmax,ss) of LY2886721||Day 14 predose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hours postdose|All randomized participants who received LY2886721 and had evaluable steady-state plasma LY2886721 concentration data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2665355|NCT01534273|Secondary|Pharmacokinetics: Plasma Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of LY2886721||Day 1 predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose|All randomized participants who received a single 70- or 140-mg dose of LY2886721 and had evaluable single-dose LY2886721 concentration data.|||nanograms*hours/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2665356|NCT01534273|Secondary|Pharmacokinetics: Plasma Maximum Observed Concentration (Cmax) of LY2886721||Day 1 predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose|All randomized participants who received a single 70- or 140-mg dose of LY2886721 and had evaluable single-dose LY2886721 concentration data.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2665357|NCT01534273|Primary|Number of Participants With Clinically Significant Effects|Data presented are the number of participants who experienced treatment-emergent adverse events. A summary of serious adverse events and other non-serious adverse events, regardless of causality is reported in the Adverse Events module.|Predose up to Day 23|All enrolled participants. Ten participants, 7 in Cohort B and 3 in Cohort C, received 70 mg LY2886721 as a single dose. Six of the participants in Cohort B went on to receive QD dosing for 14 consecutive days. These 6 participants are included in the 70 mg LY2886721 Single Dose arm and the 70 mg LY2886721 Multiple Dose arm.|||Participants|||Count of Participants
2665358|NCT01534260|Secondary|Phase II - Treatment-Related Adverse Events Grade 3 or Higher|Number of unique patients who had a treatment-related (possible, probable or definite) adverse events that were graded 3 or higher.|Up to one year|All Phase II patients who received treatment.|||Participants|||Count of Participants
2665359|NCT01534260|Secondary|Phase II - Time to Relapse|Will be examined using Kaplan-Meier estimates. Time from date of confirmed complete remission to date of relapse. The observations of patients who died or remained alive and relapse free were censored at date of death or last disease evaluation, respectively.|Up to one year|All Phase II patients who received at least one dose of study drug, had at least one evaluable post-baseline visit, and achieved complete remission|||days||95% Confidence Interval|Median
2665360|NCT01534260|Primary|Phase II - Percentage of Patients With a Partial Response or Greater|Evaluate the overall response rate of patients receiving therapy. Patients are considered as having a response if their overall response is Partial Response or better. The percentage of patients achieving this and the exact 95% confidence interval will be calculated. Responses will be defined using the response criteria determined by the International Working Group for AML.|up to 9 months|All Phase II patients who received at least one dose of study drug and had at least one evaluable post-baseline visit|||percentage of participants||95% Confidence Interval|Number
2665361|NCT01534260|Primary|Number of Patients With Dose Limiting Toxicity|The number of patients who had a DLT during the dose finding/confirming portion (Phase I) of the trial for the safety of the combination of sorafenib, vorinostat, and bortezomib.|up to 9 months|All Phase I patients receiving at least one dose of study drug and having at least one evaluable post-baseline visit|||Participants|||Count of Participants
2665362|NCT01534208|Primary|Change From Baseline in FSH|Change from baseline in FSH at end of treatment (26 weeks)|6 months||||U/L||Standard Deviation|Mean
2665371|NCT01534195|Primary|Ocular Itching Change From Baseline to Day 11|Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching).|5 minutes post-CAC|All participants who completed the study|||units on a scale||Standard Deviation|Mean
2665372|NCT01534182|Secondary|Change in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Acute (SF-36 v2 Acute)|The SF-36 is a health-related quality of life instrument used in numerous disease states, including MS (Brazier et al 1992). It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each domain was scored by adding the individual items from the domain and transforming the resulting scores into a 0 to 100 scale with higher scores indicating better health status or functioning.|Baseline, 6 months|Participants from the full analysis set were considered for this analysis. However, for a given time frame, participants analyzed had both baseline and 6 month asssessment values.|||scores on scale||Standard Deviation|Mean
2665373|NCT01534182|Secondary|Change in Patient-reported Depression|The Beck Depression Inventory (BDI-I) scale was used to measure this outcome. The scale consists of 21 items to assess the intensity of depression in clinical and normal patients. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. Each item was scored from 0 - 3. If more than one score was provided for an item, the maximum score was considered the item score. The total score was calculated as the sum of all individual items and then compared to a key to determine the depression's severity. The standard key ranges were: 0 - 9 indicated minimal depression; 10 - 18 indicated mild depression; 19 - 29 indicated moderate depression and 30 - 63 indicated severe depression. Higher total scores indicate more severe depressive symptoms.|Baseline, 6 months|FAS: The LOCF method was applied.|||scores on a scale||Standard Deviation|Mean
2665374|NCT01534182|Secondary|Changes in Patient-reported Effectiveness, Side Effects and Convenience|TSQM v 1.4 domains for effectiveness, side effects and convenience were used to evaluate this outcome. The effectiveness domain for items 1 - 3 was scored as: 1 (extremely dissatisfied) to 7 (extremely satisfied). For the side effects domain, item 4 scored as 0(no) or 1(yes); item 5 scored as 1 (extremely bothersome) to 5 (not at all bothersome); and items 6 - 8 scored as 1 (a great deal) to 5 (not at all). For the convenience domain, items 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy), and item 11 scored as 1 (extremely inconvenient) to 7 (extremely convenient). For each domain, scale scores were computed by adding the items loading on each domain. The lowest possible score was subtracted from the composite score and divided by the greatest possible score range. This provided a transformed score between 0 and 1 that was then multiplied by 100. The final transformed score ranges from 0 to 100, with higher scores indicating better treatment satisfaction.|Baseline, 6 months|FAS: The LOCF method was applied.|||scores on a scale||Standard Deviation|Mean
2665375|NCT01534182|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death|Participants were monitored for adverse events, serious adverse events and death throughout the study.|6 months|Safety Set: This set included all randomized participants who received at least one dose of study medication.|||Participants|||Number
2665376|NCT01534182|Primary|Change in Patient-reported Treatment Satisfaction|The Treatment Satisfaction Questionnaire for Medication (TSQM) contains 14 items assessing the following 4 domains: effectiveness (items 1 - 3), side effects (items 4 - 8), convenience (items 9 - 11) and global satisfaction (items 12 - 14). The primary outcome was measured on the global satisfaction domain. Item 12 scored as 1 (not at all confident) to 5 (extremely confident); item 13 scored as 1 (not at all certain) to 5 (extremely certain); and item 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). Responses to items were summed and transformed: specifically, TSQM v 1.4 domain scale scores were computed by adding the items loading on each domain. The lowest possible score was subtracted from the composite score and divided by the greatest possible score range. This provided a transformed score between 0 and 1 that was then multiplied by 100. The final transformed score ranges from 0 to 100, with higher scores indicating better treatment satisfaction.|Baseline, 6 months|Full Analysis Set (FAS): This set included all randomized participants who had taken at least one dose of study medication and had at least one post-baseline assessment of the TSQM. The last observation carried forward (LOCF) method was applied.|||scores on a scale||Standard Deviation|Mean
2665377|NCT01534143|Secondary|Recovery of T-cell, B Cell and NK Cell Phenotypes||Days 30, 60, 90, and at 6 months after transplant|||||||
2665378|NCT01534143|Secondary|Progression Free Survival||From the day of transplant to progression, death, or last contact, assessed up to 2 years|||||||
2665379|NCT01534143|Secondary|Overall Survival||Up to 2 years post transplant|||||||
2665380|NCT01534143|Secondary|Incidence of Opportunistic Infections Including CMV, HSV, and EBV Reactivation||Weekly to day 100|||||||
2665381|NCT01534143|Secondary|Incidence and Severity of Chronic GVHD||Up to 2 years post transplant|||||||
2665382|NCT01534143|Secondary|Incidence of SOS||Up to 2 years post transplant|||||||
2665383|NCT01534143|Secondary|Incidence of TTP||Up to 2 years post transplant|||||||
2665384|NCT01534143|Secondary|Incidence of Transplant Related Mortality and Morbidity||Up to 2 years post transplant|||||||
2665385|NCT01534143|Secondary|Incidence of Myeloma Progression||Time to the first observation of disease progression/relapse post transplant, assessed up to 2 years post transplant|||||||
2665386|NCT01534143|Primary|Grade III and IV Non Hematologic Toxicities|Based on NCI CTCAE version 4.|First 6 months post transplant|||||||
2665387|NCT01534143|Primary|Treatment Related Mortality Defined as Death in Continuous or Complete Remission|Based on National Cancer Institute (NCI) CTCAE version 4.|From the date of transplant to the date of death, assessed up to 6 months post transplant|||||||
2665388|NCT01534143|Primary|Time to Platelet Absolute Neutrophil Recovery (Engraftment)|Estimated using Kaplan-Meier method.|First 6 months post-transplant|||||||
2665516|NCT01532934|Secondary|Shortened Inventory of Problems With Alcohol and Drugs (SIP-AD)|A measure of consequences of drug and alcohol use across several domains (e.g., social, work, health), SIP-AD scores range from 0-45, with higher scores indicating higher levels of substance use consequences.|six months||||units on a scale||Standard Deviation|Mean
2665389|NCT01534143|Primary|Incidence and Severity of Acute GVHD Using Fludarabine Phosphate / Busulfan / Bortezomib Preparative Regimen and Triple Immune Suppression With Tacrolimus, Sirolimus and Anti-thymocyte Globulin|Graded using the Glucksberg scale. Proportions and confidence intervals will be estimated. Estimated using binary proportion estimates as well as competing risk method.|First 6 months post-transplant|Data was not collected, because funding was unavailable to continue study.||||||
2665390|NCT01534078|Secondary|Grade III or IV Adverse Events|A summary of the grade 3 or 4 adverse events experienced by participants as determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The data is shown as the number of participants that experienced at least one grade 3 or 4 adverse event for each of the specified toxicities.|2 years||||participants|||Number
2665391|NCT01534078|Secondary|Overall Response Rate|"The number of participants achieving a Partial Response (PR) or Complete Response (CR) at the end of therapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria.~CR: Disappearance of all evidence of disease~PR: Regression of measurable disease and no new sites"|End of Therapy (median duration of four months)|Two participants were not evaluated for response due to a death and a withdrawal.|||Participants|||Count of Participants
2665392|NCT01534078|Secondary|Overall Response Rate After One Cycle of Brentuximab|"The number of participants achieving a Partial Response (PR) or Complete Response (CR) after one cycle of Brentuximab monotherapy as measured via PET/CT response. Response is evaluated using the Revised International Working Group Criteria.~CR: Disappearance of all evidence of disease~PR: Regression of measurable disease and no new sites"|28 days||||Participants|||Count of Participants
2665393|NCT01534078|Primary|Complete Response Rate|Complete response rate at the end of therapy as measured by Positron emission tomography-computed tomography (PET/CT). Response is evaluated using Revised International Working Group Criteria. Complete response is defined as disappearance of all evidence of disease.|End of Therapy (median duration of four months)|Two participants were not evaluated for response due to a death and a withdrawal.|||Participants|||Count of Participants
2665394|NCT01534052|Primary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered study drug or who underwent study procedures and did not necessarily have a causal relationship with treatment. An abnormality identified during a medical test was defined as an AE only if the abnormality induced clinical signs or symptoms, required active intervention, required interruption, or discontinuation of study medication, or was clinically significant in the opinion of the investigator. An AE was defined as serious if it resulted in any of the following outcomes: Death, Was life-threatening, Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, Congenital anomaly, or birth defect, Inpatient hospitalization or prolongation of hospitalization, Other medically important event. Drug-related AEs were those assessed by the investigator as AEs whose relationship to the to the study drugs could not be ruled out.|From the date of the first dose of study drug to 30 days after last dose of study drug; the median duration of treatment was 392 days, and the maximum was 1926 days|The analysis population was the SAF.|||Participants|||Count of Participants
2665395|NCT01534013|Secondary|Insulin Requirement in Units/kg/hr|Calculation using average insulin delivered per hour and bodyweight|18 months|||||||
2665396|NCT01534013|Secondary|Glucose Area Under the Curve|Glucose area under the curve Calculation using CGM data|18 months|||||||
2665397|NCT01534013|Secondary|Closed Loop Error Grid Analysis|Closed loop error grid analysis Calculation using CGM data|18 months|||||||
2665398|NCT01534013|Secondary|Glycaemic Risk as Measured by LBGI and HBG|Glycaemic risk as measured by LBGI and HBG Calculation using CGM data|18 months|||||||
2665399|NCT01534013|Secondary|Glycaemic Variability as Measured by MAGE and SD|Glycaemic variability as measured by MAGE and SD Calculation using CGM data|18 months|||||||
2665400|NCT01534013|Secondary|% Time Spent in Hyperglycaemia|Interstitial blood glucose will be measured every 5 minutes and venous blood glucose every 15 minutes during patient visits 3, 4 and 5 when insulin is being delivered using the closed-loop insulin delivery system. The % time in euglycaemia is to be calculated using these blood glucose values.|18 months|||||||
2665401|NCT01534013|Secondary|% Time in Hypoglycaemia|Interstitial blood glucose will be measured every 5 minutes and venous blood glucose every 15 minutes during subject visits 3, 4 and 5 when insulin is being delivered using the closed-loop insulin delivery system. The % time in hypoglycaemia is to be calculated using these blood glucose values.|18 months|||||||
2665402|NCT01534013|Primary|Percentage Time in Euglycaemia|Interstitial blood glucose will be measured every 5 minutes and venous blood glucose every 15 minutes during subject visits 3, 4 and 5 when insulin is being delivered using the closed-loop insulin delivery system. The % time in euglycaemia is to be calculated using these blood glucose values.|18 months||||percentage of time|||Number
2665403|NCT01533974|Primary|Number of Participants Who Stopped Smoking by 12 Month Post Treatment|30 day point prevalence abstinence at 12 months. Missing = smoking and self report.|12 months||||participants|||Number
2665404|NCT01533948|Secondary|The Baseline Circulative Tumor Cells Value of Responders|The baseline Circulative tumor Cells values of patients with response to treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. CTC were evaluated at baseline, response was assessed up to 30 days.|Baseline|All treated and eligible patients that responded|||cells/mm^3||Standard Deviation|Mean
2665405|NCT01533948|Secondary|Median Overall Survival (OS)|The distribution will be described using Kaplan-Meier and proportional hazards methods.|From the date of study enrollment to the time of death within 30 days after last dose of study drug|All treated and eligible patients|||months||95% Confidence Interval|Median
2665406|NCT01533948|Secondary|Median Progression-free Survival (PFS)|The distribution will be described using Kaplan-Meier and proportional hazards methods. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From the date of study enrollment to the first observation of progressive disease or death within 30 days after last dose of study drug|All treated and eligible patients|||months||95% Confidence Interval|Median
2665407|NCT01533948|Secondary|Number of Patients That Experienced at Least One Grade 3 Adverse Event|Number of patients that experienced at least one grade 3 toxicity regardless of attribution. Incidence of toxicity of axitinib as a single agent as assessed by the severity of adverse effects by NCI CTCAE version 4. Please refer to the adverse event reporting for more detail.|Up to 30 days|All treated and eligible patients|||Participants|||Count of Participants
2665408|NCT01533948|Primary|Overall Response Rate (Complete Response + Partial Response) to Axitinib as Assessed Using RECIST Version 1.1|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 30 days|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2665409|NCT01533935|Secondary|FEV1 (1 Hour Post-dose)|"Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose).~The presented means are adjusted means from MMRM model."|6 weeks|All patients in FAS with available FEV1 data at baseline and week 6 are included in the analysis.|||Litres||Standard Error|Mean
2665410|NCT01533935|Secondary|Slope of the Intensity of Breathing Discomfort (Borg Scale) During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap|"Slope of the intensity of breathing discomfort (Borg Scale) during CWRCE to symptom limitation at 75% Wcap. The intensity of breathing discomfort was rated using the modified Borg scale with ratings from 0 (nothing at all) to 10 (maximal).~Slope is defined as : (intensity of breathing discomfort at the end of exercise minus intensity of breathing discomfort at rest) / endurance time.~A decrease in slope indicates improvement.~The presented means are adjusted means from MMRM model."|6 weeks|FAS|||units on a scale / s||Standard Error|Mean
2665411|NCT01533935|Primary|Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap|"Endurance time during constant work rate cycle ergometry (CWRCE) to symptom limitation at 75% Wcap~Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1.~The presented means are adjusted mean from the MMRM model."|6 weeks|FAS|||seconds||Standard Error|Geometric Mean
2665412|NCT01533935|Primary|Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity|"Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap).~Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1.~The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model."|6 weeks|Full Analysis Set (FAS) : This patient set included all patients in the TS who had the study baseline and at least 1 evaluable post-dose measurement for 1 of the primary endpoints. Assignment to the FAS was done after implementation of any data handling rules,which set measurements to missing.|||Litres||Standard Error|Mean
2665413|NCT01533922|Secondary|Forced Expiratory Volume in 1 Second (One Hour Post-dose)|"Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose)~The presented means are adjusted means from MMRM model."|6 weeks|FAS|||Litres||Standard Error|Mean
2665414|NCT01533922|Secondary|Slope of the Intensity of Breathing Discomfort During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity|"Slope of the intensity of breathing discomfort during Constant Work Rate Cycle Ergometry (CWRCE) to symptom limitation at 75% Work capacity (Wcap). The intensity of breathing discomfort was rated using the modified Borg scale with ratings from 0 (nothing at all) to 10 (maximal).~Slope of breathing discomfort is defined as: (intensity of breathing discomfort at the end of exercise minus intensity of breathing discomfort at rest) / endurance time.~A decrease in slope indicates improvement.~The presented means are adjusted means from MMRM model."|6 weeks|FAS|||units on a scale / second||Standard Error|Mean
2665415|NCT01533922|Primary|Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap|"Endurance time during constant work rate cycle ergometry (CWRCE) to symptom limitation at 75% work capacity (Wcap).~Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1.~The presented means are adjusted mean from the MMRM model."|6 weeks|FAS|||seconds||Standard Error|Geometric Mean
2665416|NCT01533922|Primary|Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap|"Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap).~Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1.~The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model."|6 weeks|Full Analysis Set (FAS) : This patient set included all patients in the TS who had the study baseline and at least 1 evaluable post-dose measurement for 1 of the primary endpoints. Assignment to the FAS was done after implementation of any data handling rules,which set measurements to missing.|||Litres||Standard Error|Mean
2665417|NCT01533753|Secondary|Assess Changes in Quality of Life Using the Hot Flash Related Daily Interference Scale (HFRDIS)|Assess percent change in quality of life from baseline to cycle 6, as measured by the Hot Flash Related Daily Interference Scale (HFRDIS) total score, between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes related to androgen deprivation therapy.|over the 6 month treatment period|Zero participants analyzed due to early termination of study||||||
2665418|NCT01533753|Secondary|Assess Changes in the Hot Flash Scores for the Two Arms|Assess percentage changes in the hot flash score from baseline to cycle 6 between gabapentin and venlafaxine in men with prostate cancer treated with for hot flashes related to androgen deprivation therapy|6 month treatment period|Zero participants analyzed due to early termination of study||||||
2665419|NCT01533753|Secondary|Compare Toxicity Rates Between the Gabapentin and Venlafaxine Treatment Groups|Toxicity rates will be compared between the two groups|over a 6 month treatment period|Zero participants analyzed due to early termination of study||||||
2665420|NCT01533753|Primary|Changes in Quality of Life|We will measure the absolute change in the Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score, between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes related to androgen deprivation therapy|observed over a 6 month treatment period|Zero participants analyzed due to early termination of study.||||||
2665421|NCT01533688|Secondary|Measure of Patients Who Develop (Tolerance)Side Effects of Taking Bowel Preparations.|Number of Participants Who Developed Side Effects of Taking Bowel Preparations|24 hours||||Participants|||Count of Participants
2665422|NCT01533688|Primary|Measure the % of Participants With Effective (How Well the Colon is Cleansed Using the Validated Boston Bowel Preparation Scale) for Various Bowel Preparations for Colonoscopy.|The investigators will measure the number/% of participants who will have good to excellent bowel preparations defined by the Boston Bowel Prep Scale(BBPS) with a score of 6 or more, rated by blinded colonoscopist.|Day 1|We have missing data regarding reporting of Boston bowel preparation scores (BBPS), some providers didn't provide the BBPS and provided only subjective assessment of the bowel preparation (for example, good or excellent)|||Participants|||Count of Participants
2665423|NCT01533597|Secondary|Change of Qmax|maximal urinary flow rate (Qmax) assessed by uroflowmetry|at week 24 relative to baseline||||mL/sec||95% Confidence Interval|Mean
2665424|NCT01533597|Secondary|Change of PVR|Change from baseline in Post-Void Residual (PVR) volume|at week 24 relative to baseline||||mL||95% Confidence Interval|Mean
2665425|NCT01533597|Secondary|Change in Score of IPSS|Total Score of IPSS(International Prostate Symptom Score) is the sum of 7 questions, ranging from 0 (best possible outcome) to 35 (worst possible outcome). The 7 symptom questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total of maximum 35 points.|at week 24 relative to baseline||||units on a scale||95% Confidence Interval|Mean
2665426|NCT01533597|Secondary|Change in Total Score of OABSS|Total Score of OABSS(Overactive Bladder Symptom Score) is the sum of 4 questions, ranging from 0 (best possible outcome) to 15 (worst possible outcome)|at week 24 relative to baseline||||units on a scale||95% Confidence Interval|Mean
2665427|NCT01533597|Secondary|Numeric Change of Urgency Episodes Per 24 Hours||at week 24 relative to baseline||||episodes||95% Confidence Interval|Mean
2665428|NCT01533597|Primary|Change in Mean Number of Micturition Episodes Per 24 Hours||at week 24 relative to baseline||||episodes||95% Confidence Interval|Mean
2665429|NCT01533493|Primary|Percent Change in Global Executive Composite T-Score on the Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)|"This is a 75-item checklist with a large normative sample, internal consistency, test-retest reliability, inter-rater reliability, and external and concurrent validity, divided into nine empirically and theoretically derived and T-scored subscales: Inhibit, Shift, Emotional Control, Self-Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Example item: I make careless errors when completing tasks. Items are rated 1 Never, 2 Sometimes, or 3 Often. The Global Executive Composite (GEC) Score is calculated by totaling all items on the scale. GEC T-scores range from 34-108, with higher scores indicating more difficulties with executive function."|baseline, 12 weeks||||percentage change from baseline score||Standard Deviation|Mean
2665430|NCT01533428|Secondary|Safety Assessed Through Adverse Events (AE) and Serious Adverse Events (SAE), Vital Signs, and Laboratory Analyses From Baseline to Week 12|Number of patients assessed for Safety through Adverse Events (AE) and Serious Adverse Events (SAE), vital signs, and laboratory analyses from baseline to week 12|Baseline to Week 12|Safety Analysis Set (SAF)|||participants|||Number
2665431|NCT01533428|Secondary|Number of Participants Who Used Rescue Pain Medication Days 1 Through 5|Summarized number of participants who used Rescue Pain Medications for Pain|Days 1 - 5|Safety Analysis Set (SAF)|||participants|||Number
2665432|NCT01533428|Secondary|"Change From Pre-application inPain Now Score"|"Change from pre-application inPain Now score was measured on a scale from 0-10 where 0 equates to No Pain and 10 to Pain as bad as you can imagine. Participants were asked to provide pain ratings relative only to the area of pain undergoing treatment."|Pre-application and 15 minutes and 60 minutes after patch removal|Safety Analysis Set (SAF)|||units on a scale||Standard Deviation|Mean
2665433|NCT01533428|Secondary|Tolerability of Patch Application Assessed by Dermal Assessment on Day 1, 15 Minutes and 60 Minutes After Patch Removal.|Tolerability of patch application was assessed by dermal assessment (0 to 7 point severity score on Dermal Assessment Scale). Data reported is based on the number of participants in the combined category with a score ≥ 4 (Definite edema or higher), 15 and 60 minutes after patch removal.|Day 1, 15 minutes and 60 minutes after patch removal|Safety Analysis Set (SAF)|||participants|||Number
2665434|NCT01533428|Secondary|Percent Change in Average Sleep Interference Score From Baseline to Between Weeks 2-8 and Weeks 2-12|"Percent change in average sleep interference was measured by Question 9F of the Brief Pain Inventory-Diabetic Neuropathy (BPI DN) and was used to assess pain and sleep interference index. Daily sleep interference rating scale consists of an 11-point numerical scale with which the patient describes how pain related to diabetes has interfered with their sleep during the past 24 hours. On a scale 0 identifies pain does not interfere with sleep and 10 identifies pain completely interferes with sleep. Average sleep interference score is assessed from baseline to Weeks 2-8 and Weeks 2-12."|Baseline, Weeks 2-8 and Weeks 2-12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.|||percentage of change||Standard Deviation|Mean
2665435|NCT01533428|Secondary|Treatment Satisfaction Assessment Based on Self-Assessment of Treatment (SAT II) Questionnaire at Baseline, Weeks 8 and 12|"Treatment satisfaction assessment based on Self-Assessment Treatment (SAT II) questionnaire and the question Over the past 7 days, how much has the study treatment improved your pain level?"|Baseline, Weeks 8 and 12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.|||participants|||Number
2665436|NCT01533428|Secondary|Change in Hospital Anxiety and Depression Scale (HADS) Depression Scale From Baseline to Weeks 2, 8 and 12.|The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, it contains 14 items rated on a 4-point Likert-type scale. There are 2 subscales,one assessing depression and the other anxiety. The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance.|Baseline to Weeks 2, 8 and 12|Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2665449|NCT01533259|Secondary|Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities|This outcome measure assessed the safety and tolerability profile of Stribild. Treatment-emergent adverse events (AEs) and graded laboratory abnormalities occurring from baseline up to 30 days following the last dose of study drug were summarized.|Up to 48 weeks plus 30 days|Safety Analysis Set|||percentage of participants|||Number
2665437|NCT01533428|Secondary|Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Scale From Baseline to Weeks 2, 8 and 12|The Hospital Anxiety and Depression Scale (HADS) is a self-report scale developed for the assessment of anxiety and depression, that contain 14 items rated on a 4-point Likert-type scale. There are 2 subscales,one assessing depression and the other anxiety. The 7-item depression and anxiety subscales yield scores of 0 to 21 that are interpreted with the following cut-off points: 0 to 7, normal; 8 to 10, mild mood disturbance; 11 to 14, moderate mood disturbance; and 15 to 21, severe mood disturbance.|Baseline to Weeks 2, 8 and 12|Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2665438|NCT01533428|Secondary|Change From Baseline in the European Quality Of Life (QOL) Questionnaire in 5 Dimensions (EQ-5D) With Visual Analog Scale (VAS) to Weeks 2, 8 and 12|Change from Baseline in the European Quality Of Life (QOL) questionnaire in 5 dimensions (EQ-5D) with Visual Analog Scale (VAS) to Weeks 2, 8 and 12. EQ-5D self-reported questionnaire is used to measure health-related quality of life by measuring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D questionnaire includes a visual analog scale (VAS) which records participants self-rated health status on a graduated (0-100) scale with higher scores indicating higher Health-Related Quality of Life (HRQoL).|Baseline to Weeks 2, 8 and 12|Intention to Treat (ITT); Baseline and Last Observation Carried Forward (BLOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2665439|NCT01533428|Secondary|Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 12|Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 12|Baseline to Week 12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.|||participants|||Number
2665440|NCT01533428|Secondary|Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 8|Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 8|Baseline to Week 8|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.|||participants|||Number
2665441|NCT01533428|Secondary|Overall Participant Status Assessed Using Patient Global Impression of Change (PGIC) Self-assessment Questionnaire in Week 2|Overall participant status assessed using Patient Global Impression of Change (PGIC) self-assessment questionnaire which was used by participants to report on 7 categories listed as follows; Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse and Very Much Worse in Week 2|Baseline to Week 2|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.|||participants|||Number
2665442|NCT01533428|Secondary|Percentage of Participants With 50% Reduction in Average Daily Pain Score.|Percentage of participants achieving 50% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, Weeks 2-8 and Weeks 2-12|Intention to Treat (ITT ); Baseline last observation carried forward(BLOCF) imputation was used.|||percentage of participants|||Number
2665443|NCT01533428|Secondary|Percentage of Participants With 30% Reduction in Average Daily Pain Score.|Percentage of participants achieving 30% decrease in the average daily pain score in Weeks 2 and 8 and Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline, Weeks 2-8 and Weeks 2-12|Intention to Treat (ITT ); Baseline last observation carried forward(BLOCF) imputation was used.|||percentage of participants|||Number
2665444|NCT01533428|Secondary|Weekly Average of Average Daily Pain at Baseline and Every Week After Baseline|Weekly average of average daily pain score at Baseline and Weeks 2,4,8 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline and Weeks 2, 4, 8 and 12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.|||units on a scale||Standard Deviation|Mean
2665445|NCT01533428|Secondary|Weekly Percent Change From Baseline in Average Daily Pain Score|Weekly Percent Change from baseline in average daily pain score from baseline to Week 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline to Weeks 2, 3, 4, 5, 6, 7, 8, 9,10, 11 and 12|Intention to Treat (ITT ); Baseline last observation carried forward (BLOCF) imputation was used.|||percentage change||Standard Deviation|Mean
2665446|NCT01533428|Secondary|Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 12|Percent Change in the Average Daily Pain Score from baseline to between Weeks 2 and 12 measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline to between Weeks 2 and 12|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.|||percentage change||Standard Deviation|Mean
2665447|NCT01533428|Primary|Percent Change in the Average Daily Pain Score From Baseline to Between Weeks 2 and 8|Percent change in the average daily pain score from baseline to between Weeks 2 and 8, measured using Question 5 of the Brief Pain Inventory-Diabetic Neuropathy (BPI-DN). Participants assessed their pain due to diabetes in the last 24 hours on a numeric rating scale from 0 (no pain) to 10 (pain as bad as you can imagine).|Baseline to between Weeks 2 to 8|Intention to Treat (ITT); Baseline Last Observation Carried Forward (BLOCF) imputation was used.|||percentage change||Standard Deviation|Mean
2665448|NCT01533259|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 48|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Weeks 24 and 48|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2665450|NCT01533259|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 12|Full Analysis Set: participants who received at least one dose of study drug and had no major protocol violations of study drug resistance at baseline.|||percentage of participants||95% Confidence Interval|Number
2665451|NCT01533246|Secondary|Progression Free Survival|Progression Free survival (PFS) time was measured as the time from the date of on study up to the date of occurrence of the first event defining a disease progression or death due to any cause, whichever occurred first.|assessed up to 2 years|Patients that received treatment|||Months||Full Range|Median
2665452|NCT01533246|Secondary|Overall Survival Based on the RECIST v1.1|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).|Up to 2 years|Patients that received treatment|||Months||Full Range|Median
2665453|NCT01533246|Secondary|Time to PSA Progression (TTPP) Analyzed Using the PCWG2 Definition|TTPP will be measured from protocol registration to appearance of PSA progression as defined by the criteria of the PSA Working Group response criteria. The end point for progression will be calculated at the time a 25% increase in PSA has been achieved.|assessed up to 12 weeks|Patients that received treatment.|||months||95% Confidence Interval|Median
2665454|NCT01533246|Secondary|Number of Patients With Bidimensional Measurable Disease RECIST-based Response|RECIST response categories: Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.|Up to 2 years|Patients with soft tissue disease only|||participants|||Number
2665455|NCT01533246|Secondary|Incidence of Toxicities Based on CTCAE Version 4.0 Criteria|Number of patients with at least possibly related to treatment toxicities grade 3 or higher based on Common Terminology Criteria for Adverse Events.|Up to 2 years|Patients that received treatment|||participants|||Number
2665456|NCT01533246|Primary|PSA Response Analyzed Using the PCWG2 Definition|Number of patients with a PSA Response will be evaluated according to the recommendations from National Cancer Institute Prostate-Cancer Working Group 2 (PCWG2) criteria. PSA decline of at least 50% from baseline confirmed by a second measurement at least 4 weeks later.|12 weeks|Patients that received treatment|||participants|||Number
2665457|NCT01533207|Other Pre-specified|Univariate and Multi-variable Prognostic Significance of Baseline Clinical, Pathologic, or Demographic Factors|Analyses will be carried out using proportional hazards models of both survival and recurrence.|Up to 5 years|||||||
2665458|NCT01533207|Secondary|Number of Participants With Recurrence|The duration of time from study entry to time of recurrence or death, whichever occurred first, or the date of last contact.|Follow-up every 4 months for 3 years, then every 6 months for 2 years.|Eligible and evaluable participants|||participants|||Number
2665459|NCT01533207|Secondary|Incidence of Grade 3 or Higher Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0||Approximately 4 years|eligible and randomized patients|||participants|||Number
2665460|NCT01533207|Primary|Number of Participants Who Experienced Death|The duration of time from study entry to time of death or the date of last contact.|Follow-up every 4 months for 3 years, then every 6 months for 2 years.|Eligible and evaluable participants|||Participants|||Number
2665461|NCT01533181|Other Pre-specified|Changes in Biomarker Expression|To be assessed by the Wilcoxon rank sum test.|Baseline to up to day 1 of course 3|||||||
2665462|NCT01533181|Secondary|Overall Survival (OS)|OS: Time from study enrollment to death from any cause. OS summarized similarly to PFS utilizing the K-M method.|Up to 2 years|All participants who received treatment|||months||95% Confidence Interval|Median
2665463|NCT01533181|Secondary|Incidence of Serious Adverse Events (SAEs) Possibly/Probably Definitely Related to Study Drugs|Participants with Grade 3 and 4 toxicities, possibly/probably/definitely related to study drugs. Number of Participants is per Event Category. Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.|1 year, 6 months|All participants who received treatment|||participants|||Number
2665464|NCT01533181|Secondary|Disease Control Rate (DCR)|DCR: Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) + Progressive Disease (PD). DCR summarized using both point estimates and exact confidence intervals based on the binomial distribution by arm.|Up to 2 years|All evaluable participants at time of analysis|||participants|||Number
2665465|NCT01533181|Primary|Median Progression Free Survival (PFS)|PFS: Time from randomization to time of disease progression or death. PFS summarized with the Kaplan-Meier (K-M) method by two arms (experimental versus control). Confidence intervals for the median PFS and PFS rates at different time points to be constructed when appropriate.|Up to 6 months|All participants who received treatment|||months||95% Confidence Interval|Median
2665466|NCT01533116|Primary|AUEC0-24 - Area Under the Effect-time Curve (AUEC) to 24 h Post-dose|AUEC0-24 - Area under the effect-time curve (AUEC) to 24 h post-dose.|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)|||pmol/mg Hb/h.h||Standard Deviation|Mean
2665467|NCT01533116|Primary|tEmax - Time of Occurrence of Maximum Observed Effect on S-COMT Activity|tEmax - time of occurrence of maximum observed effect on S-COMT activity COMT - Catechol-O-Methyltransferase|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)|||hours||Standard Deviation|Mean
2667680|NCT01513122|Primary|Mean Bone Mineral Density Changes From Baseline to 48 Weeks as Measured by DXA Scan||48 weeks|97 participants reached week 48 in 2-3N(t)RTI arm. 107 reached week 48 in the RAL arm (1 death)|||percentage change||95% Confidence Interval|Mean
2665468|NCT01533116|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point|AUC0-t - area under the plasma concentration-time curve from time 0 to last observed concentration 3-OMD - 3-O-methyl-dopa - metabolite of L-DOPA (levodopa) AUC0-t (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® AUC0-t (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® AUC0-t (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)|||ng.h/mL||Standard Deviation|Mean
2665469|NCT01533116|Primary|Tmax - Time to Maximum Plasma Concentration|Tmax - time to maximum plasma concentration Tmax (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Tmax (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Tmax (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)|||hours||Full Range|Median
2665470|NCT01533116|Primary|Cmax - Maximum Plasma Concentration|Cmax - maximum plasma concentration Cmax (Levodopa) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Cmax (3-OMD) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa® Cmax (BIA 9-1067) Sinemet® or Prolopa® - following administration of Sinemet® or Prolopa®|pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid levodopa pharmacokinetic data. In this study, 48 subjects completed the entire study and 49 had valid levodopa data (one subject had valid levodopa data until Day 21)|||ng/mL||Standard Deviation|Mean
2665471|NCT01533077|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (BIA 9-1067)|Mean pharmacokinetic parameters of BIA 9-1067|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng.h/mL||Standard Deviation|Mean
2665472|NCT01533077|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (BIA 9-1067)|Mean pharmacokinetic parameters of BIA 9-1067|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng.h/mL||Standard Deviation|Mean
2665473|NCT01533077|Primary|Tmax - Time to Occurrence of Cmax (BIA 9-1067)|Pharmacokinetic parameters of BIA 9-1067. For tmax = time to Cmax values are presented as median with range values.|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||hours||Full Range|Median
2665474|NCT01533077|Primary|Cmax - Maximum Observed Plasma Concentration (BIA 9-1067)|Mean pharmacokinetic parameters of BIA 9-1067|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng/mL||Standard Deviation|Mean
2665475|NCT01533077|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (Carbidopa)|Pharmacokinetic parameters of carbidopa. For tmax = time to Cmax values are presented as median with range values.|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng.h/mL||Standard Deviation|Mean
2665476|NCT01533077|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (Carbidopa)|Mean pharmacokinetic parameters of carbidopa|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng.h/mL||Standard Deviation|Mean
2665477|NCT01533077|Primary|Tmax - Time to Occurrence of Cmax (Carbidopa)|Pharmacokinetic parameters of carbidopa. For tmax = time to Cmax values are presented as median with range values.|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||hours||Full Range|Median
2665478|NCT01533077|Primary|Cmax - Maximum Observed Plasma Concentration (Carbidopa)|Mean pharmacokinetic parameters of carbidopa|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng/mL||Standard Deviation|Mean
2665479|NCT01533077|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (3-OMD)|Mean pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD)|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng.h/mL||Standard Deviation|Mean
2665480|NCT01533077|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (3-OMD)|Mean pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD)|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng.h/mL||Standard Deviation|Mean
2665481|NCT01533077|Primary|Tmax - Time to Occurrence of Cmax (3-OMD)|Pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD). For tmax = time to Cmax values are presented as median with range values.|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||hours||Full Range|Median
2665482|NCT01533077|Primary|Cmax - Maximum Observed Plasma Concentration (3-OMD)|Mean pharmacokinetic parameters of 3-O-methyl-levodopa (3-OMD)|Pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng/mL||Standard Deviation|Mean
2665483|NCT01533077|Primary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (L-DOPA)|Mean pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA)|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng.h/mL||Standard Deviation|Mean
2665484|NCT01533077|Primary|AUC0-t - Area Under the Plasma Concentration-time Curve to Last Measurable Time Point (L-DOPA)|Mean pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA)|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng.h/mL||Standard Deviation|Mean
2665485|NCT01533077|Primary|Tmax - Time of Occurrence of Cmax Maximum Observed Plasma Concentration (L-DOPA)|Pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA). For tmax = time to Cmax values are presented as median with range values.|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||hours||Full Range|Median
2665486|NCT01533077|Primary|Cmax - Maximum Observed Plasma Concentration (L-DOPA)|Mean pharmacokinetic parameters of L-beta-3,4-dihydroxyphenylalanine (levodopa) (L-DOPA)|pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 and 72 h after dose.|According to the protocol, the “pharmacokinetic population” should include all subjects who had valid data for all treatment periods. In this study, 18 subjects completed 2 treatment periods, 17 subjects completed 3 treatment periods and 16 subjects completed all 4 treatment periods.|||ng/mL||Standard Deviation|Mean
2665487|NCT01533038|Primary|Responder Analysis: A Subject is a Responder at the 12 Month Follow-up Time Point if All 6 Thresholds of the BPH-6 Endpoint Are Met|"LUTS: ≥ 30% reduction in IPSS compared to baseline~Recovery Experience: Return to pre-operative activity levels by 1 month~Erectile function: Less than 6-point reduction in SHIM compared to baseline.~Ejaculatory function: Response on MSHQ-EjD that indicates emission of semen. This excludes the response Could not ejaculate~Continence: ISI score of 4 points or less at all follow-up time points~Safety: No procedure-related adverse event greater than Grade I on the Clavien-Dindo classification system modified for TURP at any time during procedure or follow up."|Month 12||||% Responders of Participants|||Number
2665488|NCT01532999|Secondary|PTSD Remission|Total CAPS score of less than or equal to 45 at week 9 (single observation point)|Week 9|All participants who were randomized and attended at least one intervention session.|||percentage of participants|||Number
2665489|NCT01532999|Secondary|PTSD Response|Greater than or equal to 30% improvement on PTSD CAPS scale|Baseline to week 9|All participants who were randomized and attended at least one intervention session.|||percentage of participants|||Number
2665490|NCT01532999|Secondary|Change From Baseline in CAPS D Subscale|Clinician Administered PTSD Scale (CAPS) D subscale measures the hyperarousal cluster (i.e. D criterion) of PTSD symptoms and includes the items 13 - 17 of the CAPS, which is a clinician-administered assessment of posttraumatic stress disorder (PTSD) symptoms. Frequency and intensity scores for each item is summed for a range of 0 to 40 (higher score = more severe PTSD).|Baseline to week 9|All participants who were randomized and attended at least one intervention session.|||units on a scale||Standard Deviation|Mean
2665491|NCT01532999|Secondary|Change From Baseline in CAPS C Subscale|Clinician Administered PTSD Scale (CAPS) C subscale measures the avoidance and emotional numbing cluster (i.e. C criterion) of PTSD symptoms and includes the items 6 - 12 items of the CAPS, which is a clinician-administered assessment of posttraumatic stress disorder (PTSD) symptoms. Frequency and intensity scores for each item is summed for a range of 0 to 56 (higher score = more severe PTSD).|Baseline to week 9|All participants who were randomized and attended at least one intervention session.|||units on a scale||Standard Deviation|Mean
2665492|NCT01532999|Secondary|Change From Baseline in CAPS B Subscale|Clinician Administered PTSD Scale (CAPS) B subscale measures the re-experiencing cluster (i.e. B criterion) of PTSD symptoms and includes the first 5 items of the CAPS, which is a clinician-administered assessment of posttraumatic stress disorder (PTSD) symptoms. Frequency and intensity scores for each item is summed for a range of 0 to 40 (higher score = more severe PTSD).|Baseline to week 9|All participants who were randomized and attended at least one intervention session.|||units on a scale||Standard Deviation|Mean
2665639|NCT01531374|Secondary|Strokes and Transient Ischemic Attacks (TIAs)|Strokes (of any severity) and TIAs|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
2665493|NCT01532999|Secondary|Change From Baseline in Patient Health Questionnaire (PHQ-9)|Patient Health Questionnaire (PHQ-9) is a brief 9-item measure of depressive symptoms that has established reliability and validity in community and clinical populations. All items are summed for total score ranging from 0 to 27 (higher score = more severe depression).|Baseline to week 9|All participants who were randomized and attended at least one intervention session.|||units on a scale||Standard Deviation|Mean
2665494|NCT01532999|Secondary|Change From Baseline in Five Facet Mindfulness Questionnaire (FFMQ)|"Five Facet Mindfulness Questionnaire (FFMQ) is used to evaluate the effects of MBSR vs. PCGT on mindfulness (S1). The FFMQ is a 39-item self-report instrument that assesses the general tendency to be mindful in daily life through 5 facets: observing, describing, acting with awareness, non-judging of inner experience, non-reactivity to inner experience. Increases in FFMQ mediate improvements in well being in observational studies of MBSR. Each item is rated 1 to 5 (never or very rarely true to very often or always true). Some of the items are reverse scored (R). Scoring Information: Observe items:1, 6, 11, 15, 20, 26, 31, 36; Describe items: 2, 7, 12R, 16R, 22R, 27, 32, 37; Act with Awareness items: 5R, 8R, 13R, 18R, 23R, 28R, 34R, 38R; Nonjudge items: 3R, 10R, 14R, 17R, 25R, 30R, 35R, 39R; Nonreact items: 4, 9, 19, 21, 24, 29, 33. Total all subscales for score (higher score = greater degree of mindfulness). Score range 39-195 with higher=more mindfulness."|Baseline to week 9|All participants who were randomized and attended at least one intervention session.|||units on a scale||Standard Deviation|Mean
2665495|NCT01532999|Secondary|Change From Baseline in PTSD Checklist (PCL)|"PTSD Checklist (PCL) is a 17-item self-report scale intended to measure PTSD symptom severity. The PCL has demonstrated excellent internal consistency (alpha = .94-.97), and test-retest reliability over 2 to 3 days was .96 for Vietnam veterans. Respondents rate each item from 1 (not at all) to 5 (extremely) to indicate the degree to which they have been bothered by that particular symptom over the past month. Thus, total possible scores (items summed) range from 17 to 85 (higher score is more severe). A cut-off score of 50 indicates a probable diagnosis of PTSD."|Baseline to week 9|All participants who were randomized and attended at least one intervention session.|||units on a scale||Standard Deviation|Mean
2665496|NCT01532999|Primary|Change From Baseline in Clinician Administered PTSD Scale|Clinician Administered PTSD Scale (CAPS) is a 17-item standard rating scale that measures PTSD severity with scores ranging from 0-136 (higher score = more severe). Scores of frequency and intensity are summed for the 17-items to yield the total CAPS score.|Baseline to week 9|All participants who were randomized and attended at least one intervention session.|||units on a scale||Standard Deviation|Mean
2665497|NCT01532986|Secondary|Patient Healthcare Questionnaire-9 (PHQ-9)|"Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.~Range and direction of score: 0 (best) to 27 (worst). Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.~PHQ-9 was only administered to subjects who had a score of 3 or higher on the PHQ-2"|18 months|PHQ-9 was only administered to subjects who had a score of 3 or higher on the PHQ-2. At baseline, this was only 13 persons in usual care and 22 persons in the intervention group|||units on a scale||Standard Error|Mean
2665498|NCT01532986|Secondary|Percentage With a Patient Healthcare Questionnaire-2 (PHQ-2) Score ≥ 3|"Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.~PHQ-2 score ranges from 0 to 4. Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.~Higher scores indicate detection of depressive symptoms"|18 months||||Participants|||Count of Participants
2665499|NCT01532986|Secondary|World Health Organization Well-Being Index (WHO-5)|"Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.~Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.~Range and direction of score: 1 (worst) to 25 (best)"|18 months||||units on a scale||Standard Error|Mean
2665500|NCT01532986|Secondary|Patient Assessement of Care for Chronic Conditions (PACIC)|"Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.~Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.~Range and direction of score: 1 (worst) to 5 (best)"|18 months||||units on a scale||Standard Error|Mean
2665501|NCT01532986|Secondary|Consumer Assessment of Healthcare Providers and Systems (CAHPS)|"Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.~Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.~Range and direction of score: 0 (worst) to 100 (best)"|18 months||||units on a scale||Standard Error|Mean
2665502|NCT01532986|Secondary|General Self-Efficacy Scale (GSES)|"Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.~Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.~Range and direction of score: 10 (worst) to 40 (best)"|18 months||||units on a scale||Standard Error|Mean
2665503|NCT01532986|Secondary|Medical Outcomes Study (MOS)|"Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.~Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.~Range and direction of score: 1 (worst) to 5 (best)"|18 months||||units on a scale||Standard Error|Mean
2665504|NCT01532986|Secondary|Activities of Daily Living (ADL), (Speech and Swallowing Only)|"Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.~Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.~Range and direction of score: 0 (best) to 16 (worst)"|18 months||||units on a scale||Standard Deviation|Mean
2665505|NCT01532986|Secondary|Health Utilities Index (HUI3)|"Data collected at baseline, 6, 12, 18 months. Missing values imputed by last-value carried forward.~Reported results compared compared data of baseline and final survey results. Additional analyses included repeated-measures models that included data from all time points.~Range and direction of score: -0.36 (worst) to 1 (best)"|18 months||||units on a scale||Standard Deviation|Mean
2665506|NCT01532986|Primary|Proportion of Measures Adhered To in the PD Guidelines|"Adherence to quality measures for Parkinson's disease care during study period. We operationalized 18 quality measures: 12 were determined through chart review, and 6 were measured using patient survey data.~Range and direction of score: 0 (worst) to 1 (best)"|18 months||||proportion of quality measures followed||Standard Deviation|Mean
2665507|NCT01532973|Primary|Number of Participants Who Had Study Drug Discontinued Due to an Adverse Event|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. Participants who had study drug discontinued due to an AE were recorded.|Up to 5 days|All participants who received at least 1 dose of study drug. Event summarized by drug taken at time of event and not by panel or genotype|||Participants|||Number
2665508|NCT01532973|Primary|Number of Participants Experiencing an Adverse Event (AE) - Day 1 to Day 5|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE.|Up to 5 days|All participants who received at least 1 dose of study drug. Events reported by drug taken at time of event and not by panel or genotype|||Participants|||Number
2665509|NCT01532973|Primary|Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1a|HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.|Up to 5 days|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel.|||IU/mL||95% Confidence Interval|Least Squares Mean
2665510|NCT01532973|Primary|Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT3|HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.|Up to 5 days|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel H was not conducted.|||IU/mL||95% Confidence Interval|Least Squares Mean
2665511|NCT01532973|Primary|Mean Maximum Reduction in Log10 HCV Viral Load - HCV GT1|HCV RNA levels were assessed at baseline (predose Day 1) and 24 hours postdose on Days 1-5. using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. The change in log10 LS mean HCV RNA levels was calculated for each timepoint and the maximum change from baseline was recorded.|Up to 5 days|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel D was not conducted.|||IU/mL||95% Confidence Interval|Least Squares Mean
2665512|NCT01532973|Primary|Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT1a|HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction.|Baseline (Predose on Day 1) and 24-hour post-dose on Day 5|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel.|||IU/mL||95% Confidence Interval|Least Squares Mean
2665513|NCT01532973|Primary|Mean Reduction From Baseline in Log10 Plasma HCV RNA at Day 5 - HCV GT3|HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction|Baseline (Predose on Day 1) and 24-hour post-dose on Day 5|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel H was not conducted.|||IU/mL||95% Confidence Interval|Least Squares Mean
2665514|NCT01532973|Primary|Mean Reduction From Baseline in Log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Day 5 - HCV GT1|HCV RNA levels were assessed at baseline (predose on Day 1) and 24 hours postdose on Day 5 using the Roche TaqMan HCV 2.0 assay and transformed to Log10 values. The lower limits of quantification (LLOQ) and detection (LLD) were 25 and 9.3 IU/mL, respectively. Least squares means and confidence intervals obtained from the linear mixed model with log10 HCV RNA reduction as response and a fixed effect for treatment, time and treatment by time interaction.|Baseline (Predose on Day 1) and 24-hour post-dose on Day 5|All participants who complied with the protocol sufficiently to ensure that data would likely exhibit the effects of treatment, according to the underlying scientific model and had available data from at least 1 treatment. Data for placebo were grouped together regardless of genotype or randomly assigned panel. Panel D was not conducted.|||IU/mL||95% Confidence Interval|Least Squares Mean
2665515|NCT01532934|Secondary|New Criminal Charge|New criminal charge vs. no new criminal charge at follow-up as indicated by county database.|one year||||participants|||Number
2665517|NCT01532934|Primary|Percent Days Abstinent Per Month From Drug Use|Using timeline followback data, frequency of substance use was assessed for months three through six and presented as average percent days abstinent per month.|three to six months post baseline|105 adults (68 men and 37 women) were recruited in an urban pretrial jail diversion program. 78 (74.3%) were retained through six months. Of these, 73 were out of controlled environments (e.g., jail, inpatient treatment) for long enough to have their substance use data analyzed.|||percentage of days abstinent||Standard Deviation|Mean
2665518|NCT01532921|Secondary|Change in New York Heart Association (NYHA) Classification From Baseline Through 6 Months Post-implant|The New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. NYHA I implies no limitations. NYHA II implies slight limitation of physical activity. NYHA III implies marked limitation of physical activity and finally, NYHA IV implies patients are Unable to carry on any physical activity without discomfort.|Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant|Implanted cohort|||Participants|||Count of Participants
2665519|NCT01532921|Secondary|Change in the Right Ventricle (RV) Fractional Area From Baseline Through 6 Months Post-implant||Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant|Implanted cohort|||percentage of change||Standard Deviation|Mean
2665520|NCT01532921|Secondary|Change in the Tricuspid Annular Diameter Measured at Diastole From Baseline Through 6 Months Post-implant||Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant|Data were not collected||||||
2665521|NCT01532921|Secondary|Change in the Right Ventricle (RV) Diastolic Area From Baseline Through 6 Months Post-implant||Basline to Discharge (up to 5 days post-implant) and 6 months post-implant|Implanted Cohort|||mm2||Standard Deviation|Mean
2665522|NCT01532921|Primary|Change in the Degree of Tricuspid Valve (TV) Leaflet Tethering Height From Baseline Through 6 Months Post-implant|Change in the degree of TV leaflet tethering height measured via echocardiography from Baseline through 6 months post-implant|Baseline to Discharge (up to 5 days post-implant) and 6 months post-implant|Implanted cohort|||mm||Standard Deviation|Mean
2665523|NCT01532921|Primary|Change in Tricuspid Valve (TV) Leaflet Coaptation Length From Baseline Through 6 Months Post-implant|Change in the degree of TV leaflet coaptation length measured via echocardiography from Baseline through 6 months post-implant|Baseline to Discharge (up to 5 days post-implant) and to 6 months post-implant|Implanted cohort|||mm||Standard Deviation|Mean
2665524|NCT01532921|Primary|Change in the Degree of Tricuspid Regurgitation From Baseline Through Discharge (up to 5 Days Post-implant) and 6 Months Post-implant|"Change in the degree of tricuspid regurgitation measured via echocardiography from Baseline through 6 months post-implant. The severity of tricuspid regurgitation is graded by using several qualitative and quantitative methods. The degree of regurgitation is classified as none, Mild, Moderate or Severe."|Baseline to Discharge (up to 5 days post-implant) and through 6 months post-implant|Implanted cohort|||Participants|||Count of Participants
2665525|NCT01532921|Primary|Mean Gradient Across the Tricuspid Valve|The mean gradient across the Tricuspid Valve (TV) measured via echocardiography at discharge (up to 5 days post-implant) through 6 months post-implant|At Baseline, Discharge (up to 5 days post-implant) and 6 months post-implant|Implanted cohort|||mmHg||Standard Deviation|Mean
2665526|NCT01532869|Secondary|Percentage of Participants With Anti-Tocilizumab Antibody||Baseline, and post-baseline (up to Week 48)|Safety population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2665527|NCT01532869|Secondary|Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit|Observed data was presented for this outcome measure.|Baseline, Weeks 1, 2, 3, 8, 16, 24, and 48|Safety population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.|||pg/mL||Standard Deviation|Mean
2665528|NCT01532869|Secondary|Mean Serum Concentrations of Interleukin (IL)-6 by Visit|Observed data was presented for this outcome measure.|Baseline, Weeks 1, 2, 3, 8, 16, 24, and 48|Safety population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.|||picograms per milliliters (pg/mL)||Standard Deviation|Mean
2665529|NCT01532869|Secondary|Area Under the Concentration-Time Curve (AUC) From Time 0 to 168 Hour (AUC0-168)|AUC was a measure of the serum concentration of the drug over time which was measured in micrograms times (*) hour per milliliters (µg*hr/mL). It is used to characterize drug absorption.|Pre-dose, 24, 48, 72, 96, 120 or 144, and 168 hours post dose for Baseline and Week 16|Pharmacokinetic (PK) population included all participants who received at least one TCZ injection and had at least one PK sample with detectable results. Here, “n” = participants evaluable for the specific item at specified time point in specified time frame.|||µg*hr/mL||Standard Deviation|Mean
2665530|NCT01532869|Secondary|Change From Baseline in Tender Joint Count 28 (TJC28)|Joint tenderness was evaluated as per assessment of 28 joints. Joints on both sides of the body, including shoulders, elbows, wrists, 10 metacarpal phalangeal (MCP) joints, 10 proximal interphalangeal joint (PIP) joints, and both knees, were assessed. Joints were classified as not tender = 0 or tender = 1. Observed data was presented for this outcome measure.|Baseline, Weeks 3, 8, 16, 24, 32, 40, and 48|ITT population. Here, “n” = participants evaluable for the specific item at specified time point in specified time frame.|||joint count||Standard Deviation|Mean
2665539|NCT01532869|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 8 after last dose that were absent before treatment or that worsened relative to pretreatment state.|Week 48|Safety population.|||percentage of participants|||Number
2665531|NCT01532869|Secondary|Percentage of Participants Who Maintained or Improved in mRSS From Week 24 to Week 48|"Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement. Percentage of participants with an improvement in mRSS at Week 24 (change from baseline <0) that maintained or further improved at Week 48 were reported as Yes and No with Yes = improvers at week 24 that had a change from baseline in mRSS at Week 48 <= change from baseline at Week 24."|Week 48|ITT population. Here number of participants analyzed included those with mRSS change from baseline <0 at Week 24 and with non-missing change from baseline in mRSS at Week 48.|||percentage of participants|||Number
2665532|NCT01532869|Secondary|Change From Baseline in mRSS at Week 48|Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.|Baseline, Week 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure at specified time point up to 48 weeks.|||unit on a scale||95% Confidence Interval|Least Squares Mean
2665533|NCT01532869|Secondary|Change From Baseline in 5-D Itch Scale at Week 24 and Week 48|The 5-D Itch Scale contained five domains of duration, degree, direction, disability, and distribution. The endpoint of the scale was pruritus. Each domain was scored on a 5-point scale, the scores of each of the five domains were achieved separately and then summed together to obtain a total 5-D score. 5-D scores ranged between 5 (no pruritus) and 25 (most severe pruritus).|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.|||units on a scale||95% Confidence Interval|Least Squares Mean
2665534|NCT01532869|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy−Fatigue (FACIT-Fatigue) Score at Week 24 and Week 48|This FACIT-Fatigue Scale was a 13-item measure with participants scoring each item on a 5-point scale (0 to 4) up to 52 points. The endpoint measured was fatigue. On this scale, a numerical increase indicated an improvement in the participant's condition.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.|||units on a scale||95% Confidence Interval|Least Squares Mean
2665535|NCT01532869|Secondary|Change From Baseline in Patient's Global Assessment at Week 24 and Week 48|The Patient's Global Assessment was a patient's reported outcome that represented the participant's overall assessment of his or her current SSc on a 100 mm horizontal VAS scale (0 mm to 100 mm), with higher scores indicating worsening disease.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.|||mm||95% Confidence Interval|Least Squares Mean
2665536|NCT01532869|Secondary|Change From Baseline in Clinician's Global Assessment at Week 24 and Week 48|The Clinician's Global Assessment evaluated the overall impact of SSc on the participant as assessed by the physician on a VAS with scores ranging from 0 to 100 mm, with higher scores indicating worse disease in terms of severity, damage, or overall disease, but there was no standardization for the scale.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.|||mm||95% Confidence Interval|Least Squares Mean
2665537|NCT01532869|Secondary|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 48|The HAQ-DI scale consisted of 20 questions referring to eight component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The total score indicated the participant's self-assessed level of disability. There are four possible responses for each component: 0 = without any difficulty; 1 = with some difficulty; 2 = with much difficulty; 3 = unable to do. The HAQ-DI was the sum of the domain scores, divided by the number of domains that have a score (i.e. the average score), with total range of 0 to 3, higher scores showing larger functional limitation.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified time frame.|||units on a scale||95% Confidence Interval|Least Squares Mean
2665538|NCT01532869|Secondary|Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)|SHAQ-DI assessed five scleroderma-specific visual analogue scale (VAS) items to explore the impact of participant's disease. These items were developed to measure the effect of scleroderma on five elements of disease that could have a great impact on a participant's daily activities. Each VAS item was rated separately (0−100 millimeters [mm]), with higher scores indicating more severe disease. The five items were: 1) intestinal disease, 2) breathing problem, 3) Raynaud syndrome, 4) finger ulcers, and 5) overall disease.|Baseline, Weeks 24 and 48|ITT population. Here, number of participants analyzed included only those participants who were evaluable for this outcome measure and “n” included those who were evaluable for the specific item at specified time point in specified timeframe.|||mm||95% Confidence Interval|Least Squares Mean
2665565|NCT01532635|Secondary|Assessment of Dominance|If dominance is observed, to compare the 2 donors with regard to degree of HLA mismatch, KIR types, CD 34+ cell doses, infusion order, donor age, and donor alloreactivity points in an effort to identify potential biologic factors that predict for dominance. To determine if trends toward dominance occur in T cell, NK cell, or other cellular subsets prior to emerging in the graft as a whole.|1 year|||||||
2665540|NCT01532869|Primary|Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24|Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement.|Baseline, Week 24|Intent-to-treat (ITT) population included all participants randomized who had received any study drug at the time of the Week 24 cutoff date (14 January 2014). Here, number of participants analyzed included only those participants who were evaluable for this outcome measure at any time point up to Week 24.|||unit on a scale||95% Confidence Interval|Least Squares Mean
2665541|NCT01532830|Secondary|Mean Change in Functional Disability|Functional disability was captured in the diary and measured on a 4 point scale, where 0 = no disability, able to function normally and where 3 = performance of daily activities severely impaired, measured at baseline and 120 minutes.|Baseline and 120 minutes|Randomized population. Data was missing for 3 patients|||units on a scale||Full Range|Mean
2665542|NCT01532830|Secondary|Mean Change in Nausea From Baseline to 120 Minutes|Nausea was captured in the diary and measured on a 4 point scale, where 0 = no nausea, 1 = mild, 2 = moderate and 3 = severe nausea, at baseline and 120 minutes.|Baseline 120 minutes|Randomized population. Data was missing for 3 patients|||units on a scale||Full Range|Mean
2665543|NCT01532830|Secondary|Change in Phonophobia (Auditory) From Baseline to 120 Minutes|Presence of phonophobia (yes or no) was captured at baseline and 120 minutes.|Baseline and 120 minutes|Randomized population. Data was missing for 3 patients|||migraines with phonophobia|||Number
2665544|NCT01532830|Secondary|Change in Photophobia (Visual) From Baseline to 120 Minutes|Presence of photophobia (yes or no) was captured at baseline and 120 minutes.|Base line and 120 minutes|Randomized population. Data was missing for 3 patients|||migraines with photophobia|||Number
2665545|NCT01532830|Secondary|Mean Change in Headache Pain From Baseline to 120 Minutes|"Headache was measured on a 4 point scale where 0 = no pain, 1 = mild, 2 = moderate, 3 = severe pain at baseline (start of attack), 5, 15, 30, 45, 60, 90 and 120 minutes.~Data presented shows the average change from baseline to 120 minutes"|120 minutes|Randomized population. 2 subjects were excluded from the analysis due to protocol deviations|||units on a scale||Full Range|Mean
2665546|NCT01532830|Primary|Safety - Number of Participants With Adverse Effects|The primary outcome measure for this study was the assessment of adverse events as unanticipated or anticipated.|End of Study - 7 weeks|Randomized population|||Participants|||Count of Participants
2665547|NCT01532817|Primary|Safety- Number of Participants With Adverse Events|Safety- number of participants with adverse events, including device-related, serious or unanticipated|From time subject signs the consent through the 1-week follow-up visit|Open label study 30 participants|||Participants|||Count of Participants
2665548|NCT01532700|Secondary|Median Duration of Response|Duration of Response (DOR) is defined, for the subset of patients with a CR or PR, as the time from first documented evidence of CR or PR until first documented disease progression or death due to any cause. Duration of response will be summarized descriptively using Kaplan-Meier medians and quartiles.|36 months||||months||Inter-Quartile Range|Median
2665549|NCT01532700|Secondary|Median Progression Free Survival, Overall Survival|"Progression Free Survival (PFS) is defined as the length of time between the date of first dose of study treatment (GSK2110183) and the earliest date of disease progression or death due to any cause.~Overall survival is defined as the length of time between the date of first dose of study treatment (GSK2110183) and death due to any cause."|36 months||||months||95% Confidence Interval|Median
2665550|NCT01532700|Secondary|Stable Disease, Response Rate, Toxicity (as Graded Per NCI CTC Version 4.03)||36 months||||percentage of participants|||Number
2665551|NCT01532700|Primary|Overall Response Rate, as Per the IWCLL 2008 Response Criteria|IWCLL Response Criteria 2008-Hallek. Complete response (CR): requires peripheral blood lymphocytes < 4 x 109/L, absence of significant lymphadenopathy (>1.5cm), no organomegaly, normal CBC, bone marrow must be at least normocellular; Complete Remission with incomplete bone marrow recovery (CRi): fulfill all the criteria for CR but have persistent anemia, thrombocytopenia or neutropenia apparently unrelated to disease activity but related to drug toxicity; Partial Remission (PR): ≥ 50% decrease in the peripheral blood lymphocytes from baseline, > 50% reduction in the sum products of up to 6 lymph nodes, > 50% reduction in hepatomegaly and/or neutrophils > 1.5 x109/L, platelets > 100 x109/L, hemoglobin > 110 g/L; Stable Disease: Not CR, PR or PD (equivalent to nonresponse); Progressive Disease: Lymphadenopathy, or appearance of any new lesion/organomegaly, > 50% increase in the size of the liver and/or spleen, > 50% increase in the absolute number of circulating lymphocytes|36 months||||Participants|||Count of Participants
2665552|NCT01532648|Secondary|Change From Baseline in Inflammatory Bowel Disease-Quality of Life (IBD-QoL) Questionnaire Scores|The IBD-QoL questionnaire was self-completed by the participant. The IBD-QoL is a disease-specific instrument to evaluate the quality of life of participants with UC. This 32-item questionnaire has 4 dimensions: bowel function, emotional function, systemic symptoms, and social function. The total score is presented, which ranges from 32 to 224, with higher scores indicating a better quality of life. The scores of participants in remission usually range from 170 to 190. If >50% of the questionnaire answers for a particular dimension were missing, this dimension score was set to missing. The total score for the IBD-QoL was the sum of the domain scores, however, if any dimension score was missing, the total IBD-QoL score was set to missing.|Baseline, Days 14, 28, and 56|Participants who received at least 1 dose of study drug and had active UC at study entry as a cause of their symptoms (ITT Population) with evaluable IBD-QoL data.|||scores on a scale||Standard Deviation|Mean
2665566|NCT01532635|Secondary|Chimerism Assessment|To assess chimerism to ascertain whether one donor is emerging as dominant at regular intervals beginning at the time of engraftment.|1 year|||||||
2665567|NCT01532635|Primary|One Year Relapse-Free Survival|"To assess one year relapse-free survival (RFS) in patients undergoing HSCT (hematopoietic stem cell transplantation) using the TJU 2 step-approach with two donors.~Survival will be estimated by the Kaplan-Meier method. All estimates of rates will be presented with corresponding confidence intervals. For 1 year RFS rates, the method of Atkinson and Brown will be used to allow for the two-stage design; otherwise the method of Conover."|1 year|||||||
2665553|NCT01532648|Secondary|Number of Participants With Treatment Failure at Day 56|Treatment failure was defined as an unchanged, worsened, or missing UCDAI score at Day 56. UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Stool frequency and rectal bleeding was based on information recorded in daily participant diaries and mucosal appearance was based on endoscopy results. The diary entries were averaged for rectal bleeding and stool frequency for 3 days prior to (and closest to) Day 56 with non-missing diary data, within 5 days prior to (and closest to) Day 56. The 5 days did not include any days of the flexible sigmoidoscopy (or colonoscopy) or the preparation for the flexible sigmoidoscopy (or colonoscopy). These averages were rounded to integer values. If the subscore could not be calculated because of missing data, the score for that UCDAI component was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis.|Baseline up to Day 56|Participants who received at least 1 dose of study drug and had active UC at study entry as a cause of their symptoms (ITT Population) with evaluable UCDAI data.|||Participants|||Count of Participants
2665554|NCT01532648|Secondary|Number of Participants Who Achieved Histologic Healing at Day 56|Participants achieved histologic healing if histologic assessments of all biopsy specimens were graded as 0 (normal mucosa). If the score for ≥1 sample was missing, the overall score at that visit was set to missing. Participants with insufficient data at Day 56 were excluded from analysis.|Baseline and Day 56|Participants who received at least 1 dose of study drug and had active UC at study entry as a cause of their symptoms (ITT Population) with evaluable histologic healing data.|||Participants|||Count of Participants
2665555|NCT01532648|Secondary|Number of Participants Who Achieved Endoscopic Remission at Day 56|Endoscopic remission was defined as a score of 0 in the mucosal appearance component subscore of the UCDAI at Day 56. UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Mucosal appearance was based on endoscopy results. If the mucosal appearance subscore could not be calculated because of missing data, endoscopic remission was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis.|Screening and Day 56|Participants who received at least 1 dose of study drug and had active UC at study entry as a cause of their symptoms (ITT Population) with evaluable endoscopic response data.|||Participants|||Count of Participants
2665556|NCT01532648|Secondary|Number of Participants Who Achieved UCDAI Remission at Day 56|UCDAI remission was defined as a total UCDAI score ≤1 with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance of the colon. UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Stool frequency and rectal bleeding were based on information recorded in daily participant diaries and mucosal appearance was based on endoscopy results. The diary entries were averaged for rectal bleeding and stool frequency for 3 days prior to (and closest to) Day 56 with non-missing diary data, within 5 days prior to (and closest to) Day 56. The 5 days did not include any days of the flexible sigmoidoscopy (or colonoscopy) or the preparation for the flexible sigmoidoscopy (or colonoscopy). These averages were rounded to integer values. If the subscore could not be calculated because of missing data, the score for that UCDAI component was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis.|Baseline up to Day 56|Participants who received at least 1 dose of study drug and had active UC at study entry as a cause of their symptoms (ITT Population) with evaluable UCDAI remission data.|||Participants|||Count of Participants
2665557|NCT01532648|Secondary|Number of Participants of Who Achieved Clinical Response at Day 56|Clinical response defined as an improvement in UCDAI from Baseline of ≥3 points with a rectal bleeding score ≤1. UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Rectal bleeding was based on information recorded in daily participant diaries. The diary entries were averaged for rectal bleeding for 3 days prior to (and closest to) Day 56 with non-missing diary data, within 5 days prior to (and closest to) Day 56. The 5 days did not include any days of the flexible sigmoidoscopy (or colonoscopy) or the preparation for the flexible sigmoidoscopy (or colonoscopy). These averages were rounded to integer values. If either subscore could not be calculated because of missing data, the score for that UCDAI component was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis.|Baseline up to Day 56|Participants who received at least 1 dose of study drug and had active UC at study entry as a cause of their symptoms (ITT Population) with evaluable clinical response data.|||Participants|||Count of Participants
2665558|NCT01532648|Primary|Number of Participants Who Achieved Clinical Remission at Day 56|Clinical remission defined as a score of 0 for rectal bleeding and 0 for stool frequency components from the Ulcerative Colitis Disease Activity Index (UCDAI). UCDAI is the sum (0 to 12) of 4 severity scores (0 to 3). Stool frequency and rectal bleeding were based on information recorded in daily participant diaries. The diary entries were averaged for rectal bleeding and stool frequency for 3 days prior to (and closest to) Day 56 with non-missing diary data, within 5 days prior to (and closest to) Day 56. The 5 days did not include any days of the flexible sigmoidoscopy (or colonoscopy) or the preparation for the flexible sigmoidoscopy (or colonoscopy). These averages were rounded to integer values. If either subscore could not be calculated because of missing data, the score for that UCDAI component was set to missing. Participants with insufficient data at Day 56 were excluded from the analysis. Participants who had clinical remission at Baseline were classified as non-responders.|Baseline up to Day 56|Participants who received at least 1 dose of study drug and had active ulcerative colitis (UC) at study entry as a cause of their symptoms (Intent-To-Treat Population [ITT]) with evaluable clinical remission data.|||Participants|||Count of Participants
2665559|NCT01532635|Secondary|Assessment for Tumor Escape Mechanisms|To test for loss of one or both HLA haplotypes in patients who relapse post-transplant and examine the relapse in the context of the characteristics of the 2 donors|1 year post transplant|||||||
2665560|NCT01532635|Secondary|Tolerance of DLI|Assessment of the tolerance of the period of fever, diarrhea, and rash after the introduction of second donor and qualitatively compare it to prior patient groups or concurrent patient groups|2-6 days prior to transplant|||||||
2665561|NCT01532635|Secondary|Non-relapse Morbidity and Mortality|Assessment of regimen related toxicity, GVHD incidence and severity, and overall survival.|1 year|||||||
2665562|NCT01532635|Secondary|Immune Reconstitution|Assess T and B cell Reconstitution|1 year|||||||
2665563|NCT01532635|Secondary|Engraftment|To assess the consistency and pace of engraftment of both donors.|1 year|||||||
2665564|NCT01532635|Secondary|Relapse Rates|To assess if establishment of a dominant donor versus persistent chimerism of both donors is associated with a lower relapse rate.|1 year|||||||
2665568|NCT01532570|Secondary|Change From Baseline in Clinical Symptoms Associated With Vascular BD Patients|"The investigator assessed the clinical symptoms associated with vascular-BD at each time point of the evaluation in compared to Week 0, in accordance with the categories as No symptom, Improved, Unchanged or Worsened."|Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54||||participants|||Number
2665569|NCT01532570|Secondary|Change From Baseline in Clinical Symptoms Associated With Neuro-BD Patients|"The investigator assessed the clinical symptoms associated with neuro-BD at each time point of the evaluation in compared to Week 0, in accordance with the categories as No symptom, Improved, Unchanged or Worsened."|Week 2, 6, 10, then every 4 weeks after Week 14 to Week 54||||participants|||Number
2665570|NCT01532570|Secondary|The Number of Improved Intestinal BD Patients From Baseline|"The investigator assessed clinical symptoms associated with intestinal BD in one week before the day of evaluation as  No symptom, Very slightly poor, Slightly poor, Poor or Extremely poor.~We calculated improved patients in comparison with those for Week 0."|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54||||participants|||Number
2665571|NCT01532570|Secondary|Interleukin-6 (IL-6) Concentration in CSF for Neuro-BD||Week 0, Week 14, Week 30, Week 54||||pg/mL|||Number
2665572|NCT01532570|Secondary|Cell Counts in Cerebrospinal Fluid (CSF) for Acute Neuro-BD|The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.|Week 0, Week 14, Week 30, Week 54||||cells/mL|||Number
2665573|NCT01532570|Secondary|Level of Inflammatory Biomarker (Erythrocyte Sedimentation Rate) of Vascular BD|The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54||||mm/hr||Inter-Quartile Range|Median
2665574|NCT01532570|Secondary|Concentration of Inflammatory Biomarker (CRP) of Vascular BD|The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54||||mg/dL||Inter-Quartile Range|Median
2665575|NCT01532570|Secondary|Concentration of Inflammatory Biomarker (C-reactive Protein (CRP)) of Intestinal BD|The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study.|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54||||mg/dL||Inter-Quartile Range|Median
2665576|NCT01532570|Secondary|Imaging Findings: CT, PET/CT for Vascular-BD|"Changes in CT or PET/CT findings were scored at day of evaluation, in accordance with the following categories, Improves, Unchanged or Worsened by comparison with those at Week 0."|Week 14, Week 30, Week 54||||participants|||Number
2665577|NCT01532570|Secondary|Imaging Findings: Brainstem MRI for Chronic Neuro-BD|"Changes in brainstem MRI findings were scored at day of evaluation, in accordance with the following categories, Unchanged or Reduced in the brainstem area compared to Week 0."|Week 14, Week 30, Week 54||||participants|||Number
2665578|NCT01532570|Secondary|Imaging Findings: Brain Magnetic Resonance Imaging (MRI) for Acute Neuro-BD|"Changes in brain MRI findings were scored at day of evaluation, in accordance with the following categories, No high-intensity areas, Reduction or No changes/increase in the size of high-intensity areas compared to Week 0."|Week 14, Week 30, Week 54||||participants|||Number
2665579|NCT01532570|Secondary|Imaging Findings:Endoscopic Examination for Intestinal BD|"The investigator assessed the length of the major axis of the principal intestinal ulcer at day of evaluation and scored in accordance with the following categories, Healed/scarred, Reduced to =< 25%, Reduced to > 25% to =< 50% or Reduced to > 50%/no change/increased in the principal intestinal ulcer compared to size at Week 0."|Week 14, Week 30, Week 54||||participants|||Number
2665580|NCT01532570|Secondary|Patient General Visual Analogue Scale (VAS) for the Clinical Symptoms Associated With Each BD|"The VAS evaluation measured using the General VAS evaluation From and the range is from 0 to 100 mm. The best condition per one week before evaluation visit for the clinical symptoms associated with each BD is defined as 0 and the worst condition is defined as 100.~The time of final evaluation : Final time point for the 5 mg/kg patients, final time point during administration of 5 mg/kg for the 10 mg/kg patients, final time point during administration of 5 mg/kg for patients who discontinued the study."|Week 0, 2, 6, 10, then every 4 weeks after Week 14 to Week 54||||units on a scale||Standard Deviation|Mean
2665581|NCT01532570|Secondary|Percentage of Participants With Complete Response at Week 14 and 54|"We defined the patient who met the following criteria as the complete responders.~The criteria of complete responders are that clinical symptoms associated with each BD have disappeared and morphological characteristics (ex. ulcers area, CT or PET/CT findings etc) at the lesion site and inflammatory markers (ex. cerebrospinal fluid and serum inflammatory markers) are improved compared to Week 0."|Week 14, Week 54||||percentage of Complete Responders|||Number
2665582|NCT01532570|Primary|Percentage of Participants With Complete Response at Week 30|"We defined the patient who met the following criteria as the complete responders.~The criteria of complete responders are that clinical symptoms associated with each BD have disappeared and morphological characteristics (ex. ulcers area, Computed tomography (CT) or Positron emission tomography/Computed tomography (PET/CT) findings etc) at the lesion site and inflammatory markers (ex. cerebrospinal fluid and serum inflammatory markers) are improved compared to Week 0."|Week 30||||percentage of Complete Responders|||Number
2665583|NCT01532453|Secondary|Number of Patients With New Actinic Keratoses, Squamous Cell Carcinomas or Basal Cell Carcinomas||2 Years|"The Full analysis set (FAS) comprised 220 patients: 146 in the MD 3511356 group and 74 in the standard care group.~For patient 10018 (MD-3511356 group) the age of first organ transplant was not computable due to missing date."|||percentage of patients|||Number
2665584|NCT01532453|Primary|Number of New Clinically Diagnosed Actinic Keratoses or Squamous Cell Carcinomas||2 Years|241 patients were randomized: 160 to the MD 3511356 group and 81 to the standard care group. All 241 randomized patients received at least one dose of trial device and therefore were all included in the safety population. The Full analysis set (FAS) comprised 220 patients: 146 in the MD 3511356 group and 74 in the standard care group.|||new actinic keratoses or scc||Standard Deviation|Mean
2665585|NCT01532414|Primary|Subjects With 50% or Greater Decrease in Sperm Concentration Comparison of Proportion of Subjects With 50% or Greater Decrease in Sperm|"Proportion of subjects with a 50% or greater decrease in sperm concentration from baseline after 12 weeks of treatment in Androxal treated subjects to placebo.~The difference between the proportions (placebo minus Androxal) and corresponding 95% confidence interval was determined and compared to the equivalence limit of -20%. If the lower limit of the 95% confidence interval was greater than -20%, then Androxal would be concluded to be non-inferior to placebo in causing a 50% reduction in sperm concentrations."|3 months|ITT.|||percentage of participants|||Number
2665586|NCT01532414|Primary|Proportion (Percentage) of Androxal Treated Subjects With Testosterone in the Normal Range|"Proportion of pooled Androxal subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment. Cavg will be calculated as the numerical average of 24-hour serial testosterone assessments at 0, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours after dosing.~If the lower limit of the 95% confidence interval for the Androxal treatment group at Week 12 is at least 67%, then the co-primary endpoint based on the Cavg for testosterone has been achieved.~FDA specified primary endpoint did not include comparison to placebo, thus the proportion of placebo subjects with average serum concentration (Cavg) for T in the normal range (300 - 1040 ng/dL) after 12 weeks of treatment was not calculated."|3 months|ITT population.|||Percentage of Subjects|Participants|95% Confidence Interval|Number
2665587|NCT01532362|Secondary|Effect of Apricoxib on Levels of CD4+CD25+ T Regulatory Cells in Peripheral Blood.Also,Biomarkers of Apoptosis Resistance,Angiogenesis,Invasion and Immunity Will be Tested in the Lab to Check How Effective Apricoxib is in Inhibiting These Proteins.|Peripheral blood from patients with NSCLC has been reported to have an increase in the percentages of CD4+CD25+ T reg cells.In contrast <10% of the PBLs of normal donors have this phenotype. As such, CD4+CD25+ cells will be assessed in addition to FOXP3 levels in PBL. In addition, exploration of COX-2 dependent biomarkers of apoptosis resistance, angiogenesis, invasion, and immunity will be studied. COX-2, FOXP3, IL-10, IL-12, MDC, CXCR4 and survivin will be analyzed in plasma.|7 days|||||||
2665588|NCT01532362|Primary|Compare Level of CD4+CD25high T Lymphocyte Regulatory Cells in Peripheral Blood Lymphocytes and Tumor Infiltrating Lymphocytes From Surgical Resection Specimens of Subjects With Early Stage NSCLC Who Have Received Apricoxib to Those Who Have Not|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries. Peripheral blood and urine will be obtained on Days 0 and 7 from both groups (prior to surgical incision). Bronchoalveolar lavage (BAL) and lymph node tissue will be obtained on Days 0 and 7. TIL will be obtained from surgical resection specimens of the primary lung tumor only on Day 7|7 days|No analysis occurred||||||
2665589|NCT01532349|Primary|Change in Serum Hepcidin With Vitamin D Intervention for Children With Chronic Kidney Disease|The null hypothesis to be tested is that Vitamin D supplementation will not be associated with a decrease in serum hepcidin over the study period. Statistical analysis will be performed as intention-to-treat.|change from baseline to up to three months||||ng/ml||Inter-Quartile Range|Median
2665590|NCT01532141|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose||||ng.h/mL||Standard Deviation|Mean
2665591|NCT01532141|Secondary|Time of Occurrence of Cmax (Tmax)|6-mL blood samples for the determination of plasma concentrations of BIA 9-1067 and/or rasagiline will be drawn by direct venipuncture or via an intravenous catheter into potassium ethylenediaminetetraacetic acid(EDTA)Vacutainers|pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose||||hours||Full Range|Median
2665592|NCT01532141|Primary|Cmax - Maximum Observed Plasma Drug Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose||||ng/mL||Standard Deviation|Mean
2665593|NCT01532128|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose||||ng.h/mL||Standard Deviation|Mean
2665594|NCT01532128|Secondary|Tmax - Time of Occurrence of Cmax||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose||||hours||Full Range|Median
2665595|NCT01532128|Primary|Cmax - Maximum Observed Plasma Concentration||pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose||||ng/mL||Standard Deviation|Mean
2665596|NCT01532089|Other Pre-specified|Predictive Value of Plasma VEGF-A Levels on Progression Free Survival in Patients Treated With Erlotinib Hydrochloride Alone or in Combination With Bevacizumab|Evaluated using time-dependent receiver operating characteristic curve and area under curve.|Baseline|||||||
2665597|NCT01532089|Other Pre-specified|EGFR T790M Mutations|Detected from pre-treatment tumor specimen using allele specific quantitative polymerase chain reaction (PCR). The PFS of patients with EGFR T790M mutations will be estimated and the survival difference will be tested using Cox proportional hazard model after adjusting for treatment effect. The robustness of treatment effect in different subgroups will be examined in a Forest plot.|Up to 6 years|||||||
2665598|NCT01532089|Other Pre-specified|Prevalence of EGFR T790M Resistance Mutations From Pretreatment > Tumor Biopsies Using More Sensitive Mutation Detection Methods|Tested using Cox proportional hazard model after adjusting for treatment effect. The robustness of treatment effect in different subgroups will be examined in a Forest plot.|Baseline|||||||
2665599|NCT01532089|Other Pre-specified|EGFR Mutations Detected in Tumor Deoxyribonucleic Acid (DNA)|Agreement of EGFR mutations detected in plasma DNA with those detected in tumor DNA will be evaluated.|Up to 6 years|||||||
2665600|NCT01532089|Other Pre-specified|EGFR Mutations Detected in Plasma Deoxyribonucleic Acid (DNA)|Agreement of EGFR mutations detected in plasma DNA with those detected in tumor DNA will be evaluated.|Up to 6 years|||||||
2665601|NCT01532089|Secondary|Number of Patients Experiencing Toxicity|The number of patients experiencing toxicity defined as grade 3 or higher adverse events (using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0) considered at least possibly related to treatment is reported below.|Up to 42 days after treatment discontinuation||||Participants|||Count of Participants
2665638|NCT01531374|Secondary|Index Procedure Related MAEs||Procedure|Participant Population = Consisted of all subjects with an attempted implant procedure.|||percentage of participants|||Number
2665602|NCT01532089|Secondary|Progression Free Survival of Patients With Different Mutation Types (Exon Deletion 19 Versus Exon 21 L858R)|Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator by mutation type.|From the date of randomization to the date of disease progression or death of any cause, whichever comes first, assessed up to 6 years|This analysis includes all patients with EGFR exon mutation data available and primary endpoint data available.|||months||95% Confidence Interval|Median
2665603|NCT01532089|Secondary|Response Rate (Complete or Partial) to Each Treatment, Evaluated Using the New International Criteria Proposed by the Revised Response Evaluation Criteria in Solid Tumors Guidelines (Version 1.1)|The response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites).|Up to 6 years|Patients with tumor response data available were included in this analysis.|||percentage of patients||95% Confidence Interval|Number
2665604|NCT01532089|Secondary|Overall Survival|Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Time from randomization to death of any causes, assessed up to 6 years||||months||95% Confidence Interval|Median
2665605|NCT01532089|Primary|Progression Free Survival (PFS)|Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Time from randomization to disease progression and death of any cause, whichever comes first, assessed up to 6 years||||months||95% Confidence Interval|Median
2665606|NCT01531998|Secondary|Number of Participants With Response|Overall response defined as number of participants with International Myeloma Working Group Uniform Response Criteria: Complete Response (CR): Negative immunofixation serum & urine, Disappearance soft tissue plasmacytomas & =/<5% plasma cells in bone marrow; Stringent Complete Remission: CR + Normal Normal free light chain (FLC) ratio & Absence clonal cells in bone marrow by Immunohistochemistry/ immunofluorescence; Very Good Partial Response (VGPR): Serum & urine M-protein detectable by immunofixation but not on electrophoresis or 90%> reduction in serum M-protein +urine M-protein level <100mg per 24 hour; Partial Remission (PR): =/>50% reduction serum M-protein & reduction in 24-hour urinaryMprotein by >90% or to < 200mg per 24 hour, =/>50% reduction of serum M-protein & reduction in 24-hour urinary Mprotein by >90%/or <200mg, and if present at baseline, a >50% reduction in size of soft tissue plasmacytomas; Stable Disease: Not CR, VGPR, PR Or Progressive disease|Evaluated after eight cycles of 21 days.||||participants|||Number
2665607|NCT01531998|Primary|Maximum Tolerated Dose (MTD) of Siltuximab|Maximum tolerated dose (MTD) defined as follows: At first dose level, if greater than 1 out of 3 patients or greater than 1 out of 6 patients experience dose limiting toxicity (DLT), the dose level exceeds the maximum tolerated dose (MTD). Dose limiting toxicity (DLT) defined as toxicities graded in severity according to the guidelines outlined in the NCI-Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.|21 days||||mg/kg|||Number
2665608|NCT01531894|Primary|Number of Participants With at Least One Adverse Events (AEs)|Adverse Events (AEs) includes Summary of adverse events, drug related AEs, Serious adverse events, adverse events leading to study treatment discontinuation and death.|from the time of consent until the final study visit up to approx. 76 months|The ‘all treated subjects’ population consisted of all subjects that received at least one dose of afuresertib in this rollover study.|||Participants|||Count of Participants
2665609|NCT01531725|Secondary|Major Adverse Cardiac Events (MACE)|MACE is defined as a composite of death, myocardial infarction, target lesion revascularization and coronary artery bypass grafting.|at 180 days post procedure|Patients with follow up available either 180 or 360 days post procedure.|||participants|||Number
2665610|NCT01531725|Primary|Target Vessel Failure (TVF)|Target vessel failure is defined as composite of revascularization, recurrent myocardial infarction, or cardiac death.|at 180 days post procedure|Patients with follow up data available either 180 or 360 days post procedure.|||participants|||Number
2665611|NCT01531673|Secondary|AUC0-24h of VX-661 and AUC0-12h of Ivacaftor After Administration of VX-661 in Combination With Ivacaftor|Participants who received VX-661 in combination with Ivacaftor (Group 2b, 3b, 4, 5b, 6a, 6d and 7) were analyzed for this outcome measure. PK analysis was not planned for placebo reporting arms.|Day 28|The analysis was done using PK Set.|||ng*h/mL||Standard Deviation|Mean
2665612|NCT01531673|Secondary|Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24h) of VX-661 After Administration of VX-661 Monotherapy|Participants who received VX-661 monotherapy (Group 1, 2a, 3a and 5a) were analyzed for this outcome measure. PK analysis (AUC0-24h) was not planned for placebo reporting arms.|Day 28|The analysis was done using Pharmacokinetics (PK) Set.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Mean
2665613|NCT01531673|Secondary|Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 7|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Day 14, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, 'Number Analyzed' = those participants who were evaluable at the specified time points for each group, respectively.|||units on a scale||95% Confidence Interval|Least Squares Mean
2667701|NCT01512758|Secondary|Concentrations of Relevant Tumor Markers||Cycle 1, Day 1; at end of Cycle 2 and every 2 cycles thereafter; and at end treatment; approximately 12 months|Data was not analyzed as per the change in planned analysis (protocol amendment).||||||
2665614|NCT01531673|Secondary|Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 6|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. As per planned analysis, participants who received placebo in Group 4 and 6 were combined and compared with Group 6.|Baseline, Day 14, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, 'Number Analyzed' = those participants who were evaluable at the specified time points for each group, respectively.|||units on a scale||95% Confidence Interval|Least Squares Mean
2665615|NCT01531673|Secondary|Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 1-5b|The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.|Baseline, Day 14, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, 'Number Analyzed' = those participants who were evaluable at the specified time points for each group, respectively.|||units on a scale||95% Confidence Interval|Least Squares Mean
2665616|NCT01531673|Secondary|Change in FEV1 (L) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 7|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Day 7, Day 14, Day 21, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug.|||Liters||95% Confidence Interval|Least Squares Mean
2665617|NCT01531673|Secondary|Change in FEV1 (L) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 6|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. As per planned analysis, participants who received placebo in Group 4 and 6 were combined and compared with Group 6.|Baseline, Day 7, Day 14, Day 21, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, 'Number Analyzed' = those participants who were evaluable at the specified time points for each group, respectively.|||Liters||95% Confidence Interval|Least Squares Mean
2665618|NCT01531673|Secondary|Change in FEV1 (Liter [L]) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 1-5b|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Day 7, Day 14, Day 21, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here 'Number Analyzed' = those participants who were evaluable at the specified time points for each group, respectively.|||Liters||95% Confidence Interval|Least Squares Mean
2665619|NCT01531673|Secondary|Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 7|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Day 7, Day 14, Day 21, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug.|||percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
2665620|NCT01531673|Secondary|Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 6|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. As per planned analysis, participants who received placebo in Group 4 and 6 were combined and compared with Group 6.|Baseline, Day 7, Day 14, Day 21, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each group, respectively.|||percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
2665621|NCT01531673|Secondary|Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) From Baseline to Each Visit and From Baseline Through Study Day 28 for Group 1-5b|FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.|Baseline, Day 7, Day 14, Day 21, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each group, respectively.|||percent predicted of FEV1||95% Confidence Interval|Least Squares Mean
2665622|NCT01531673|Secondary|Change in Sweat Chloride From Baseline to Each Visit up to Study Day 28 for Group 7|Sweat samples were collected using an approved collection device. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug.|Baseline, Day 7, Day 14, Day 21, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each group, respectively.|||mmol/L||95% Confidence Interval|Least Squares Mean
2665623|NCT01531673|Secondary|Change in Sweat Chloride From Baseline to Each Visit up to Study Day 28 for Group 6|Sweat samples were collected using an approved collection device. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug. As per planned analysis, participants who received placebo in Group 4 and 6 were combined and compared with Group 6.|Baseline, Day 7, Day 14, Day 21, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each group, respectively.|||mmol/L||95% Confidence Interval|Least Squares Mean
2665624|NCT01531673|Secondary|Change in Sweat Chloride From Baseline to Each Visit up to Study Day 28 for Group 1-5b|Sweat samples were collected using an approved collection device. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug.|Baseline, Day 7, Day 14, Day 21, Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint and ‘Number Analyzed’ = those participants who were evaluable at the specified time points for each arm, respectively.|||mmol/L||95% Confidence Interval|Least Squares Mean
2665625|NCT01531673|Primary|Change in Sweat Chloride From Baseline Through Study Day 28 for Group 7|Sweat samples were collected using an approved collection device. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug.|Baseline through Day 28|The analysis was done using FAS which included all randomized participants who received at least 1 dose of study drug. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint.|||mmol/L||95% Confidence Interval|Least Squares Mean
2665626|NCT01531673|Primary|Change in Sweat Chloride From Baseline Through Study Day 28 for Group 6|Sweat samples were collected using an approved collection device. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug. As per planned analysis, participants who received placebo in Group 4 and 6 were combined and compared with Group 6.|Baseline through Day 28|The analysis was done using Full Analysis Set (FAS) which included all randomized participants who received at least 1 dose of study drug. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint.|||mmol/L||95% Confidence Interval|Least Squares Mean
2665627|NCT01531673|Primary|Change in Sweat Chloride From Baseline Through Study Day 28 for Group 1-5b|Sweat samples were collected using an approved collection device. Baseline was defined as the most recent non-missing measurement collected before initial administration of study drug.|Baseline through Day 28|The analysis was done using Full Analysis Set (FAS) which included all randomized participants who received at least 1 dose of study drug. Here, ‘Number of participants analyzed’ = those participants who were evaluable for this endpoint.|||millimole per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2665628|NCT01531673|Primary|Safety as Determined by Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the Informed Consent Form is signed. AE includes serious as well as non-serious AEs. Serious Adverse Event (SAE) is any AE that results in any of the following: death; life-threatening condition; inpatient hospitalization or prolongation of hospitalization; persistent or significant disability or incapacity; congenital anomaly or birth defect; or other important medical event. Treatment-emergent adverse events are defined as adverse events that were reported or worsened on or after start of study drug through the Follow-up Visit (28 days after last dose of study drug) or premature discontinuation.|Start of study drug through the Follow-up Visit (Up to Day 56)|Analysis was done using safety set which included all participants who received at least 1 dose of study drug.|||participants|||Number
2665629|NCT01531387|Secondary|Quality of Life|Standard Quality of Life measure will be taken during specific time points, as well as one newly-developed Sickle Cell Disease Quality of Life measure.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.||||||
2665630|NCT01531387|Secondary|Cumulative Incidence of Non-Neurological Events|The cumulative incidence of non-neurological sickle cell-related events, including vaso-occlusion and splenic sequestration, will be estimated over the treatment period for both standard and alternative arms.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.||||||
2665631|NCT01531387|Secondary|Cumulative Incidence of Neurological Events|The cumulative incidence of neurological events as a secondary endpoint, which include both stroke and non-stroke neurological events, will be determined over the treatment period for both standard and alternative arms.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.||||||
2665632|NCT01531387|Secondary|Serial TCD Velocities|This secondary outcome measure will be the highest TAMV obtained in specific arteries. Serial TCD velocities are measured throughout the SCATE trial and will be compared to the baseline value.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the secondary outcome measures were not analyzed.||||||
2665633|NCT01531387|Primary|Conversion to Abnormal Maximum TAMV|The primary endpoint of the SCATE trial is the cumulative incidence of conversion to abnormal maximum TAMV (time-averaged mean velocity) measured by transcranial doppler (TCD) ultrasonography. Subjects must have conditional velocities at baseline, defined as 170 - 199 cm/sec, which indicate moderate stroke risk. Abnormal velocities are defined as ≥ 200 cm/sec, which indicate high stroke risk. The number of conversions from conditional velocities to abnormal velocities in each treatment arm will be compared as the primary outcome.|30 months|No participants reached 30 months of treatment prior to study termination; therefore, the primary outcome measure was not analyzed.||||||
2665634|NCT01531374|Secondary|Prosthetic Valve Dysfunction (PVD)|"PVD was defined according to VARC using the site reported echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total AR reported as moderate or severe was considered PVD. AS was defined as significant stenosis and considered PVD if one of the following was met:~Peak velocity >4 m/s~Mean gradient >35 mmHg~EOA < 0.8 cm2~TVIV1 / TVIV2 < 0.25"|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with a valve implanted.|||Percentage of participants|||Number
2665635|NCT01531374|Secondary|Procedural Success|Defined as device success and absence of in-hospital MACCE.|Number of days from admission to discharge|Participant Population = Consisted of all subjects with an index procedure who were evaluable for procedural success.|||percentage of participants|||Number
2665636|NCT01531374|Secondary|Device Success|"Defined as:~Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system,~Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function),~Intended performance of the prosthetic valve (aortic valve area > 1.2 cm2 for 26, 29 and 31mm valves, ≥ 0.9 cm2 for 23mm valve (by echocardiography using the continuity equation) and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/sec, without moderate or severe prosthetic valve aortic regurgitation)~Only one valve implanted in the proper anatomical location"|Number of days from admission to discharge|Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for device success.|||percentage of participants|||Number
2665637|NCT01531374|Secondary|Length of Index Procedure Hospital Stay||Number of days from admission to discharge|Participant Population = Consisted of all subjects with an attempted implant procedure.|||days||Standard Deviation|Mean
2665641|NCT01531374|Secondary|Aortic Valve Hospitalizations||30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
2665642|NCT01531374|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measure:~- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular) analyzed overall per Extreme Risk or High Risk. Iliofemoral access and non-iliofemoral access are not reported separate because this is a valve performance measurement."|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with a valve implanted.|||percentage of participants|||Number
2665643|NCT01531374|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measure:~• Transvalvular Mean Gradient analyzed overall per Extreme Risk or High Risk. Iliofemoral access and non-iliofemoral access are not reported separate because this is a valve performance measurement."|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population= Consisted of all subjects with a valve implanted.|||mmHg||Standard Deviation|Mean
2665644|NCT01531374|Secondary|Echocardiographic Assessment of Valve Performance|"Using the following measure:~• Effective Orifice Area (EOA) analyzed overall per Extreme Risk or High Risk. Iliofemoral access and non-iliofemoral access are not reported separate because this is a valve performance measurement."|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with a valve implanted.|||cm^2||Standard Deviation|Mean
2665645|NCT01531374|Secondary|Quality of Life (QoL) Change|"QoL summary score change from baseline using the following measures:~Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.~12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.~European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state."|30 day, 6 month, 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.|||units on a scale||Standard Deviation|Mean
2665646|NCT01531374|Secondary|Ratio of Days Alive Out of Hospital at 365 Days Post Procedure Versus Total Days Alive||1 year|Participant Population= Consisted of all subjects with an attempted implant procedure.|||ratio of days alive and out of hospital||Standard Deviation|Mean
2665647|NCT01531374|Secondary|Change From Baseline in Distance Walked During 6-Minute Walk Test (6MWT)|Change in distance walked during 6MWT from baseline|Baseline to 30 days, baseline to 1 year|Participant Population = Consisted of all subjects with an attempted implant procedure.|||meters||Standard Deviation|Mean
2665648|NCT01531374|Secondary|Change From Baseline in NYHA Class|"Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement.~NYHA Classification:~Class I: Subjects with cardiac disease but without resulting limitations of physical activity.~Class I: Subjects with cardiac disease resulting in slight limitation of physical activity.~Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.~Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort."|Baseline to 30 days, baseline to 6 months, baseline to 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.|||average classification level change||Standard Deviation|Mean
2665649|NCT01531374|Secondary|Conduction Disturbance Requiring Permanent Pacemaker Implantation||30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
2665650|NCT01531374|Secondary|Major Adverse Events (MAEs)|"MAEs Include:~MACCE~Acute Kidney Injury~Cardiac Tamponade~Prosthetic Valve Dysfunction~Cardiogenic Shock~Valve Endocarditis~Life-Threatening, Disabling or Major Bleeding~Major Vascular Complication~Cardiac Perforation~Device Migration/Valve Embolism"|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
2665651|NCT01531374|Secondary|The Occurrence of Individual MACCE Components|"Individual MACCE Components Include:~All Cause Mortality~MI~All stroke~Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
2665652|NCT01531374|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~All-Cause Death~Myocardial Infarction (MI)~All Stroke~Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.|Participant Population = Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
2665653|NCT01531374|Primary|Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality|All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)|1 year|Participant Population = Consisted of all subjects with an attempted implant procedure.|||percentage of participants, Kaplan-Meier|||Number
2665654|NCT01531335|Secondary|Insulin Requirements|This is an indirect measure of glycemic control, and is reported as a daily average.|Daily until day 21 or discharge from ICU||||International Unit of insulin||Standard Deviation|Mean
2665779|NCT01529385|Primary|Cutaneous Water Content|Cutaneous water content was measured non-invasively by tissue dielectric constant (MoistureMeter) at a single location: 2 inches distal and 2 inches lateral to the fibular head.|change from baseline after 4 weeks of sock usage||||percentage change in dielectric constant||95% Confidence Interval|Mean
2665655|NCT01531335|Primary|SOFA (Sequential Organ Failure Assessment) Score|SOFA score evaluates six systems: respiratory, cardiovascular, coagulation, Central Nervous System, liver and renal. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality).|48 hours since nutritional regime starts||||units on a scale||Standard Deviation|Mean
2665656|NCT01531205|Secondary|Incidence of Detecting Circulating Tumor Cells (CTC)|To determine the feasibility of detecting circulating tumor cells in this patient population. CTC results per patient in milliliters.|One Year|All participants|||CTC/mL|||Number
2665657|NCT01531205|Secondary|Incidence of Perioperative and Postoperative Morbidity|Number of events. To access the perioperative and postoperative morbidity with salvage surgery after neoadjuvant hormonal ablation and Cabazitaxel.|One Year|Participants who proceeded to surgery|||events|||Number
2665658|NCT01531205|Secondary|Incidence of Complete Response (CR)|Percentage of participants with CR post surgery. To evaluate the pathological complete response rate to androgen ablation plus Cabazitaxel in patients with locally recurrent prostate cancer following radiation therapy. Pathological Complete Response (pCR): Participants with no residual cancer in the local resection specimen and pelvic lymph nodes will be considered pCR.|One Year|Participants who proceeded to surgery|||percentage of participants|||Number
2665659|NCT01531205|Secondary|Incidence of PSA Progression Free Survival (PFS)|Percentage of participants with stable (has not increased) or undetectable PSA post surgery. To assess Prostate-specific antigen(PSA)-progression free survival and prostate cancer specific survival for patients treated by chemohormonal therapy followed by salvage surgery for biopsy proven androgen-dependent high-risk locally recurrent prostate cancer following radiation therapy.|Four Months|Participants who proceeded to surgery|||percentage of participants|||Number
2665660|NCT01531205|Primary|Surgical Margin Negative Rate (SM Rate)|Post surgery percentage of participants with negative surgical margin. To determine the surgical margin negative rate in patients who have undergone chemohormonal therapy followed by surgery for biopsy proven androgen-dependent high risk locally recurrent prostate cancer following primary radiation therapy. Margin: The edge or border of the tissue removed in cancer surgery. The margin is described as negative or clean when the pathologist finds no cancer cells at the edge of the tissue, suggesting that all of the cancer has been removed. The margin is described as positive or involved when the pathologist finds cancer cells at the edge of the tissue, suggesting that all of the cancer has not been removed.|One Year|Participants who proceeded to surgery|||percentage of participants|||Number
2665661|NCT01531153|Secondary|Digit Span- DSB|Digit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Digit Span Forward (DSB) is the number of digit span trials participants got correct in the backward condition. Higher scores are better (Scale of 0 to 14).|Baseline and 12 Weeks|Complete cases at 12 weeks were analyzed.|||units on a scale||Standard Deviation|Mean
2665662|NCT01531153|Secondary|Digit Span- LDSB|Digit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Longest Digit Span Backward (LDSB) is the longest digit span participants got correct, in the backward condition. Higher scores are better (Scale of 0 to 8).|Baseline and 12 Weeks|Complete cases at 12 weeks were analyzed.|||units on a scale||Standard Deviation|Mean
2665663|NCT01531153|Secondary|Digit Span- DSF|Digit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Digit Span Forward (DSF) is the number of digit span trials participants got correct in the forward condition. Higher scores are better (Scale of 0 to 14).|Baseline and 12 Weeks|Complete cases at 12 weeks were analyzed.|||units on a scale||Standard Deviation|Mean
2665664|NCT01531153|Secondary|Digit Span- LDSF|Digit Span Task description: Orally administered (not computerized) task where subjects are read-aloud lists of digits and asked to repeat them in the same order they heard them (Forward condition). Subjects are given a pair of lists for each digit length - and given a point for each list they get entirely correct. If they get at least one out of the two correct for that length, then the researcher gives them another one of a longer length (one digit longer). If they get both wrong at a given length- that task is ended. The task is then repeated with different digit lists to recall, but they are asked to repeat them or in the reverse order that they heard them (Backward condition). Longest Digit Span Forward (LDSF) is the longest digit span a participant gets correct, in the forward condition. Higher scores are better (Scale of 0 to 9).|Baseline and 12 Weeks|Complete cases at 12 weeks were analyzed.|||units on a scale||Standard Deviation|Mean
2665679|NCT01530997|Secondary|The Eating Assessment Tool (EAT-10) Composite Score|The EAT-10 is a 10 item, validated self-administered instrument for documenting dysphagia severity. This questionnaire uses symptom-specific scores to assess dysphasia with solids, liquids, and pills as well as the impact of dysphagia on mental, social, and physical health. Higher raw scores represent worse QoL. All items have a 0-4 scale where 0 represents no problem and 4 represents severe problem. Total score can range from 0 to 40.|Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT||||units on a scale||95% Confidence Interval|Mean
2665665|NCT01531153|Secondary|Stroop- Effect Drug Neutral Mean Correct|Drug Stroop Task is a computerized task which presents words either cocaine-related ('drug') words or non-drug-related ('neutral') words written in colored font. The subject is asked to press a button to indicate the color of the font as quickly and accurately as possible. The task is thought to measure attentional bias to drug-related stimuli. Stroop Effect is difference in response time to drug versus neutral trials (i.e., RT Correct Drug - RT Correct Neutral). A larger stroop effect is 'worse' (thought to indicate more attentional bias to drug related stimuli).|weeks 0, 4, 8, 12, 16, 24, 36|Data are reported for those that were assessed at each visit.|||milliseconds||Standard Deviation|Mean
2665666|NCT01531153|Secondary|Stroop- RT Correct Drug|Drug Stroop Task is a computerized task which presents words either cocaine-related ('drug') words or non-drug-related ('neutral') words written in colored font. The subject is asked to press a button to indicate the color of the font as quickly and accurately as possible. The task is thought to measure attentional bias to drug-related stimuli. RT Correct Drug is the mean response time to drug trials where the subject pressed the correct color response.|weeks 0, 4, 8, 12, 16, 24, 36|Data are reported for those that were assessed at each visit.|||milliseconds||Standard Deviation|Mean
2665667|NCT01531153|Secondary|Stroop- RT Correct Neutral|Drug Stroop Task is a computerized task which presents words either cocaine-related ('drug') words or non-drug-related ('neutral') words written in colored font. The subject is asked to press a button to indicate the color of the font as quickly and accurately as possible. The task is thought to measure attentional bias to drug-related stimuli. RT Correct Neutral is the mean response time to neutral trials where the subject pressed the correct color response.|weeks 0, 4, 8, 12, 16, 24, 36|Data are reported for those that were assessed at each visit.|||milliseconds||Standard Deviation|Mean
2665668|NCT01531153|Secondary|CANTAB SST- SD Correct|This is the CANTAB SST measure which evaluates response inhibition. Stop Signal Reaction Time (SSRT): The estimate of the length of time between the go stimulus and the stop stimulus at which the subject is able to successfully inhibit their response on 50% of the trials. Range of scores from 0 to 1500 (unit=milliseconds) and lower scores are 'better'. SD Correct is the standard deviation of response times across 'go' trials where the subject has responded on the correct button (right or left).|Baseline and 12 Weeks|Complete cases analyzed at baseline and 12 weeks.|||milliseconds||Standard Deviation|Mean
2665669|NCT01531153|Secondary|CANTAB SST- Median Correct|This is the CANTAB SST measure which evaluates response inhibition. Stop Signal Reaction Time (SSRT): The estimate of the length of time between the go stimulus and the stop stimulus at which the subject is able to successfully inhibit their response on 50% of the trials. Range of scores from 0 to 1500 (unit=milliseconds) and lower scores are 'better'. Median correct is the median of response times across 'go' trials where the subject has responded on the correct button (right or left).|Baseline and 12 Weeks|Complete cases analyzed at baseline and 12 weeks.|||milliseconds||Standard Deviation|Mean
2665670|NCT01531153|Secondary|CANTAB SST- SSRT|This is the CANTAB SST measure which evaluates response inhibition. Stop Signal Reaction Time (SSRT): The estimate of the length of time between the go stimulus and the stop stimulus at which the subject is able to successfully inhibit their response on 50% of the trials. Range of scores from 0 to 1500 (unit=milliseconds) and lower scores are 'better'.|Baseline and 12 Weeks|Complete cases analyzed at baseline and 12 weeks.|||milliseconds||Standard Deviation|Mean
2665671|NCT01531153|Secondary|CANTAB RVIP Measure: RVP FALSE ALARM|RVIP is a computerized measure of attention. This is given at baseline and every 4 weeks over the course of the 12-week study. RVP FALSE ALARM is probability of false alarm. False alarms are responses to non-targets. Higher numbers are worse (i.e., could be seen as a measure of poor response inhibition). Scores range from 0-1 where 1 is the least desirable probablity.|Baseline and 12 Weeks|complete case analysis at 12 weeks|||units on a scale||Standard Deviation|Mean
2665672|NCT01531153|Secondary|CANTAB RVIP Measure: RVP B|"RVIP is a computerized measure of attention. This is given at baseline and every 4 weeks over the course of the 12-week study. RVP B: A measure of response bias (i.e., bias towards under-responding (to targets) versus over-responding (i.e., to non-targets)) range from -1 to +1, respectively."|Baseline and 12 Weeks|complete case analysis at 12 weeks|||units on a scale||Standard Deviation|Mean
2665673|NCT01531153|Secondary|CANTAB RVIP Measure: RVP A|RVIP is a computerized measure of attention. This is given at baseline and every 4 weeks over the course of the 12-week study. RVP A' (aka RVIP A PRIME): is a signal detection measure of target sensitivity (i.e., successful response to targets and withholding of responses to non-targets). Range of 0 to 1. Higher scores are better.|Baseline and 12 Weeks|complete case analysis at 12 weeks|||units on a scale||Standard Deviation|Mean
2665674|NCT01531153|Secondary|Blood Pressure- Diastolic|Blood Pressure is taken for safety reasons|2 times a week for 12 weeks|Data are reported for those that were measured at each assessment.|||mmHg||Standard Deviation|Mean
2665675|NCT01531153|Secondary|Blood Pressure- Systolic|Blood Pressure is taken for safety reasons|2 times a week for 12 weeks|Data are reported for those that were measured at each assessment.|||mmHg||Standard Deviation|Mean
2665676|NCT01531153|Secondary|Heart Rate|Pulse|once a day for up to two days over 12 Weeks|Summary data for only those measured at each week are presented (per protocol).|||beats per minute (bpm)||Standard Deviation|Mean
2665677|NCT01531153|Primary|Urine Toxicology|Presented are the average number of urine samples positive for cocaine over 12 weeks. This outcome was corrected from the protocol registration when the study data were entered.|12 weeks||||average cocaine positive urine samples||Standard Deviation|Mean
2665678|NCT01530997|Secondary|The Rosenbek Penetration Aspiration Scale|"The Rosenbek Penetration Aspiration Scale will be used to quantify dysphagia. It is an 8-point, equal-appearing interval scale to describe penetration and aspiration events. The measure was used for thin substances, pureed substances, and solid substances.~1. Material does not enter airway 2. Material enters the airway, remains above the vocal folds, and is ejected from the airway. 3. Material enters the airway, remains above the vocal folds, and is not ejected from the airway. 4. Material enters the airway, contacts the vocal folds, and is ejected from the airway. 5. Material enters the airway, contacts the vocal folds, and is not ejected from the airway. 6.Material enters the airway, passes below the vocal folds, and is ejected into the larynx or out of the airway. 7. Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal folds, and no effort is made to eject."|Prior to CRT and 4-8 weeks after completion of CRT||||units on a scale||Standard Deviation|Mean
2665680|NCT01530997|Secondary|European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL|The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions which incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. A higher score=better level of functioning or greater degree of symptoms.|Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT||||units on a scale||95% Confidence Interval|Mean
2665681|NCT01530997|Secondary|European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35|"The head & neck cancer module of the EORTC QLQ comprises 35 questions assessing symptoms and side effects of treatment, social function and body image/sexuality.~The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); several single item questions (Pain killers, nutritional supplements, feeding tube, weight loss, and weight gain) were just coded as no=1, yes=2. The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning)."|Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT||||units on a scale||95% Confidence Interval|Mean
2665682|NCT01530997|Secondary|Overall Survival Rate|The percentage of participants who are still alive from the start of treatment.|Median follow-up was 36 months with a range of 5-53 months.||||percentage of participants|||Number
2665683|NCT01530997|Secondary|Distant Metastases Free Survival|Distant metastases free survival is the percentage of subjects in a study who have survived without cancer spread.|the median follow-up was 36 months with a range of||||percentage of participants|||Number
2665684|NCT01530997|Secondary|Cause-Specific Survival|Cause-specific survival is the percentage of participants who have not died from low-risk low-risk OPSCC.|The median follow-up was 36 months with a range of 5-53 months||||percentage of participants|||Number
2665685|NCT01530997|Secondary|Regional Control|Regional control is the percentage of participants who displayed control of cancer in sites that represent the first stages of spread from the local origin.|Median follow-up was 36 months with a range of 5-53 months||||percentage of participants|||Number
2665686|NCT01530997|Secondary|Two-Year Local Control|Local control is the arrest of cancer growth at the site of origin.|Median follow-up was 36 months with a range of 5-53 months||||percentage of participants|||Number
2665687|NCT01530997|Primary|Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC).|Pathologic Complete Response Rate is defined as no evidence of residual viable cancer in the evaluated pathological specimens.|6 to 14 weeks after the last patient is enrolled, or approximately 24 to 32 months after study being opened|Following the completion of chemoradiation therapy (CRT), 1 patient refused the planned surgical evaluation and 43 patients were evaluated.|||Participants|||Count of Participants
2665688|NCT01530880|Secondary|Bleeding Incidence|Incidence of bleeding (defined by a priori criteria)|Up to 14 days|PI left before data could be analyzed and data collection was incomplete.||||||
2665689|NCT01530880|Secondary|Difference in Cost Between Ibuprofen and Acetaminophen|Cost analysis of aggressive fever control (AFC) between patients randomized to either intravenous ibuprofen infusion or standard of care (oral acetaminophen).|Up to 14 days|PI left before data could be analyzed and data collection was incomplete.||||||
2665690|NCT01530880|Secondary|Mean Difference in Inflammatory Markers|Mean difference in markers of inflammation between IV ibuprofen and standard of care groups|Up to 14 days|PI left before data could be analyzed and data collection was incomplete.||||||
2665691|NCT01530880|Primary|Prevalence of Fever Burden|Reduction in fever burden (degrees C x hours) with intravenous ibuprofen infusion as compared to oral acetaminophen over duration of treatment. Fever burden is calculated hourly by subtracting each patient's recorded temperature (from either a bladder or esophageal temperature probe) from 37 degrees C.|Up to14 days|PI left before data could be analyzed and data collection was incomplete.||||||
2665692|NCT01530477|Primary|Short Term Precision Comparison Across Three DXA Devices|"BMD precision will be reported across three DXA devices in major skeletal and body composition sites. The short-term precision was calculated as RMS-SD (root mean square standard deviation) over the mean for each cohort. The skeletal cohort will not have short-term precision value for body composition indexes due to the different region of measurement. The same will apply to the body composition cohort. As the result, the Skeletal & Body Composition cohort identified in participant flow and overall study summary will not have an analysis provided."|Less than 6 months||||Percentage of variance|||Number
2665693|NCT01530464|Primary|Area Under the Curve Post Dosing (AUC_0-infinity) of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|"Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)~Blood sample collections for plasma Ambrisentan and Theophylline determinations at 0-hour (pre-dose), and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose"|24h after dosing||||h*ng/ml||Standard Deviation|Median
2665694|NCT01530464|Primary|Area Under the Curve Within 24 Hours Post Dosing (AUC_0-24 Hours) of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|"Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)~Blood sample collections for plasma Ambrisentan and Theophylline determinations at 0-hour (pre-dose), and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose"|24h after dosing||||h*ng/ml||Standard Deviation|Median
2667772|NCT01512225|Secondary|Mean Breast Milk Volumes on Day 14|Mean milk volumes between the two groups at 14 days of study intervention|Day 0 and day 14||||millilitres||Standard Deviation|Mean
2665695|NCT01530464|Primary|Maximum Plasma Concentration (Cmax) of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)|24h after dosing||||ng/ml||Standard Deviation|Median
2665696|NCT01530464|Primary|Time Until Maximum Plasma Concentration (Tmax) of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|"Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)~Blood sample collections for plasma Ambrisentan and Theophylline determinations at 0-hour (pre-dose), and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose"|24h after dosing||||hours||Standard Deviation|Median
2665697|NCT01530464|Primary|Plasma Halflife of Theophylline (Aminophylline) and Ambrisentan When Administered Alone or in Combination|"Aminophylline Alone (Single Dose of 500mg Aminophylline) Aminophylline in Presence of Ambrisentan (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan in Presence of Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)~Blood sample collections for plasma Ambrisentan and Theophylline determinations at 0-hour (pre-dose), and at 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post dose"|24 hours after dosing||||hours||Standard Deviation|Median
2665698|NCT01530464|Primary|Mean Number of Adverse Events Following Each Dose|"Dosing schedule:~Aminophylline Alone (Single Dose of 500mg Aminophylline) Ambrisentan Alone (Single Dose of 5mg Ambrisentan) Ambrisentan and Aminophylline (Combined Single Dose of 500mg Aminophylline and 5mg Ambrisentan)"|48 h following each dose||||Mean number of adverse events||Standard Deviation|Mean
2665699|NCT01530399|Primary|Chest Tube Drainage at 12 Hours After Surgery||12 hours post CABG||||mL||Inter-Quartile Range|Median
2665700|NCT01530334|Secondary|Time to Worsening of Disease Related Symptoms|Time to worsening of disease related symptoms (LCS) Time to worsening of disease-related symptoms based on FACT-L LCS was defined as the interval from the date of enrollment to the first visit response of 'worsened' without a subsequent response of 'improved' or 'no change' within 21 days (or to the last assessment), death due to any cause, or early discontinuation from the study. Time to worsening was censored at the last non-missing assessment visit if the worsening was not observed.|every 6 weeks after the Start of Study Treatment until the worsening of desease related symptoms or time of data cut off (6 months after the last patient has started study treatment)|Analysis performed on EFS & FAS population|||days|Participants|95% Confidence Interval|Median
2665701|NCT01530334|Secondary|Treatment Duration With Gefitinib|Treatment duration was calculated from the date of the first to the date of the last intake.|every 6 weeks after the Start of Study Treatment until discontinuation of drug or time of data cut off (6 months after the last patient has started study treatment)|Analysis performed on EFS & FAS population|||days|Participants|95% Confidence Interval|Median
2665702|NCT01530334|Secondary|Overall Survival (OS)|OS was calculated as the time from the first dose until the day of death from any cause. Any patient not known to have died at the time of data analysis was censored at the time of the last follow-up date.|every 6 weeks after the Start of Study Treatment until death or time of data cut off (6 months after the last patient has started study treatment)|Analysis conducted both in FAS and EFS population|||days|Participants|95% Confidence Interval|Median
2665703|NCT01530334|Secondary|Progression Free Survival|Progression free Survival was calculated as the time from the first dose of gefitinib study treatment until the date of (i) progression or (ii) death from any cause in the absence of progression.|every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment)|PFS was analysed on FAS and EFS population|||Days|Participants|95% Confidence Interval|Median
2665704|NCT01530334|Primary|Clinical Benefit Rate|"Clinical benefit rate is the sum of patients with a best visit response of Complete Response, Partial Response or Stable Desease Objective Response Rate is the sum of Complete response (CR) and Partial Response (PR) response.~Evaluated by recist criteria v 1.1., for target lesions and assesed by CT or MRI: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR),>=30% decrease in the sum of longest diamteter of target lesions, Stable Desease (SD) defined as no progression for>= 6 weeks. Objective response rate (RR)=CR+PR"|every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment)|CBR was analyzed both on FAS and EFS population|||Patients|Participants||Number
2665705|NCT01530334|Primary|Objective Response Rate|"Objective Response Rate is the sum of Complete response (CR) and Partial Response (PR) response.~Evaluated by recist criteria v 1.1., for target lesions and assesed by CT or MRI: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR),>=30% decrease in the sum of longest diamteter of target lesions; Objective response rate (RR)=CR+PR"|every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment)|Analysis performed both in the FAS population (i.e. all enrolled patients into the study) and in EFS population (i.e. all screened patients who entered and received at least one dose of study agent)|||Patients|Participants||Number
2665706|NCT01530243|Other Pre-specified|Pain|The visual analogue scale (VAS) was used to evaluate the pain at the time of voiding. This VAS scoring ranges from 0 to 10. The higher values represent worse outcomes, having more pain.|Expected 2 weeks later||||units on a scale||Standard Deviation|Mean
2665707|NCT01530243|Secondary|Quality of Life|The Quality of life of patients was evaluated using single question in IPSS questionnaire in which each of patients received scoring from 0 to 6. The higher values represent the worse quality of life.|Expected 2 weeks later||||units on a scale||Standard Deviation|Mean
2665734|NCT01529645|Primary|GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens|The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.|Day 30 post vaccination/baseline (Day 1)|Analysis was done on the per-protocol population.|||Ratio||95% Confidence Interval|Geometric Mean
2665708|NCT01530243|Primary|Lower Urinary Tract Symptoms (LUTS)|LUTS was evaluated using the International Prostate Symptom Score (IPSS) questionnaire perioperatively. The IPSS constitutes of seven questions assigned score from 0 to 5 to evaluate the severity of LUTS in patients. Total scoring of IPSS ranges from 0 to 35, asymptomatic to very symptomatic. The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes.|Expected average of 2 weeks|The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes.|||units on a scale||Standard Deviation|Mean
2665709|NCT01530178|Primary|Better Targeted Blood Glucose Levels|The current trial is designed to detect a significant difference in the mean glucose levels in the treatment group|1 Year||||mg/dl||Standard Deviation|Mean
2665710|NCT01530087|Secondary|Security|wear time leakage barrier erosion|30 days|Study was stopped ; no data are available||||||
2665711|NCT01530087|Primary|Peristomal Skin Condition|mean irritation score using a categorical scale with range of 1(normal) to 5(eroded or heaemorrhagic dermatitis)|1 - 30 days|Study was stopped due to inability to inability to enroll. No data are available for any outcome measures.||||||
2665712|NCT01529827|Secondary|Median Time to Neutrophil Engraftment|Median time to recovery of absolute neutrophil count >=500/uL for 3 consecutive days. Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.|Day 100|All treated and eligible patients|||days||Full Range|Median
2665713|NCT01529827|Secondary|Progression Free Survival (PFS) at One Year|Assessed using Kaplan Meier and Proportional Hazards|day of transplant until progression up to 5 years|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2665714|NCT01529827|Secondary|Clinical Response|"Patients will be followed according to response criteria as referenced in BMT SOP Standards of Therapy last updated 2008. Clinical Response = CR + PR.~Complete Response Requires all of the following:~Serum and urine negative for monoclonal proteins by immunofixation~Normal free light chain ratio~Plasma cells in marrow < 5%~Partial Response (PR) Requires any of the following:~- ≥ 50% reduction in current serum monoclonal protein levels > 0.5 g/dL or urine light chain levels > 100 mg/day with a visible peak or free light chain levels > 10mg/dL~Progressive Disease (PD) Requires any of the following:~If progressing from CR, any detectable monoclonal protein or abnormal free light chain ratio (light chain must double)~If progressive from PR or SD, ≥ 50% increase in the serum M protein to > 0.5 g/dL,or ≥ 50% increase in urine M protein to > 200mg/day with visible peak present.~Free light chain increase of ≥ 50% to"|In the first 100 days from day 0 of transplant|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2665715|NCT01529827|Primary|Transplant Related Mortality (TRM)|Day 100 transplant related mortality (TRM). An exact 95% confidence interval will be provided.|In the first 100 days from day 0 of transplant|All treated and eligible patients|||percentage of participants||95% Confidence Interval|Number
2665716|NCT01529749|Secondary|Changes in CD4 CD38+ HLADR+ (%)|Marker of activation in CD4 T cells. This Outcome Measure is reporting a change in the percentage of CD4 CD38+ HLADR+ T cells at 48 months minus the percentage at 0 weeks (baseline)|0, 48 weeks||||percentage of CD4 T cells||Inter-Quartile Range|Median
2665717|NCT01529749|Secondary|Number of Participants With Adverse Events and Laboratory Abnormalities in the Different Groups.||up to 48 weeks||||participants|||Number
2665718|NCT01529749|Secondary|Proportion of Patients With Improvement in Neuropsychological Test||48 weeks||||participants|||Number
2665719|NCT01529749|Secondary|Proportion of Patients With Changes in Levels of Proteins.||48 weeks||||participants|||Number
2665720|NCT01529749|Secondary|Proportion of Patients With Changes in Levels of CSF Cells.||48 weeks||||participants|||Number
2665721|NCT01529749|Secondary|Proportion of Patients With Changes in Levels of beta2-microglobulin.||48 weeks||||participants|||Number
2665722|NCT01529749|Secondary|Proportion of Patients With Changes in Levels of Metalloproteinases||48 weeks||||participants|||Number
2665723|NCT01529749|Secondary|Proportion of Patients With Reduced Intima-media Complex in Carotid Ultrasound in Different Groups.||48 weeks|Carotid ultrasound was performed at baseline in 41 out the 42 patients. However, only 36 patients repeated the ultrasound at week 48, and were included in the analysis (9 in each randomised group).|||participants|||Number
2665724|NCT01529749|Secondary|Changes in the CD4/CD8 Ratio in Peripheral Blood in Different Groups.||48 weeks||||ratio||Inter-Quartile Range|Median
2665725|NCT01529749|Secondary|Proportion of Patients With Undetectable Viral Load in Lymphatic Tissue in Different Groups||week 48||||participants|||Number
2665726|NCT01529749|Secondary|Proportion of Patients With Undetectable Plasma Viral Load in Different Groups||48 weeks||||participants|||Number
2665727|NCT01529749|Secondary|Proportion of Patients With Increased CD4 in Lymphatic Tissue.||week 48||||participants|||Number
2665728|NCT01529749|Secondary|Proportion of Patients With Increased CD4 in Peripheral Blood.||48 weeks||||participants|||Number
2665729|NCT01529749|Secondary|Proportion of Patients With Changes in the Levels of D-dimer in Different Groups.||48 weeks||||participants|||Number
2665730|NCT01529749|Secondary|Proportion of Patients With Changes in the Levels of CRP in Different Groups.||48 weeks||||participants|||Number
2665731|NCT01529749|Secondary|Proportion of Patients With Changes in the Levels of IL-6 in Different Groups.||48 weeks||||participants|||Number
2665732|NCT01529749|Primary|Proportion of Patients With 50% Reduction of Fibrosis in Lymphatic Tissue.||48 weeks|Eligibility criteria were being older than 18 years, being on ART with a combined triple therapy regimen and having viral load under the limit of detection for at least the previous 48 weeks.|||participants|||Number
2665733|NCT01529645|Primary|Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination|The percentages of subjects demonstrating diphtheria and tetanus antitoxin units >= 0.1/mL following vaccination with different antigenic formulations of TdaP booster vaccine, is compared to the response to commercially available comparator.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population.|||percentages of subjects||95% Confidence Interval|Number
2665809|NCT01529268|Secondary|Resolution of NASH|Patients with a change from a histological diagnosis of definite NASH or indeterminate for NASH to not NASH at end of treatment|52 weeks|Analysis was limited to patients with a diagnosis of definite NASH at baseline.|||participants|||Number
2665735|NCT01529645|Primary|GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens|The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported.|Day 30 post vaccination/baseline (Day 1)|Analysis was done on the per-protocol population.|||Ratio||95% Confidence Interval|Geometric Mean
2665736|NCT01529645|Primary|Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens|The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for different antigenic formulations of aP booster vaccines and for licensed comparator are reported.|Day 30 post vaccination/baseline (Day 1)|Analysis was done on the per-protocol population.|||Ratio||95% Confidence Interval|Geometric Mean
2665737|NCT01529645|Secondary|GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens|The GMRs of post vaccination versus pre vaccination GMCs of antibodies against diphtheria and tetanus antigens for different formulations of TdaP booster and commercially available comparator versus GMCs at baseline are reported.|Day 30 post vaccination/Day 1|Analysis was done on the per-protocol population.|||Ratio||95% Confidence Interval|Geometric Mean
2665738|NCT01529645|Secondary|GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination|The GMCs of antibodies against diphtheria and tetanus antigens following vaccination with different formulations of TdaP booster are compared with the response to the commercially available comparator.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population.|||IU/mL||95% Confidence Interval|Geometric Mean
2665739|NCT01529645|Secondary|Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination.|Comparison of antibody responses against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of aP and TdaP booster vaccines and licensed comparator, are reported in terms of the percentages of subjects demonstrating 2- and 4-fold increase in GMCs from baseline.|Day 30 post vaccination|Analysis was done on the per-protocol population.|||percentage of subjects||95% Confidence Interval|Number
2665740|NCT01529645|Primary|GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination|The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP booster groups, against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population.|||µg/mL||95% Confidence Interval|Geometric Mean
2665741|NCT01529645|Primary|GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination|The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP Booster Groups against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population.|||µg/mL||95% Confidence Interval|Geometric Mean
2665742|NCT01529645|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination|The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) on aP booster groups, against pertussis antigens pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), following vaccination with different antigenic formulations of aP versus the response to the commercially available comparator are reported.|Day 1 (baseline) and Day 30 post vaccination|Analysis was done on the per-protocol population, ie, all subjects who correctly received the vaccine, and provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to unblinding.|||µg/mL||95% Confidence Interval|Geometric Mean
2665743|NCT01529645|Primary|The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine|The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed in terms of the number of subjects reporting any unsolicited adverse events (AEs) between day 1 to day 30 , serious adverse events (SAEs) and AEs leading to premature withdrawal between day 1 to day 365, after vaccination.|From day 1 to day 365|Analysis was done on the safety set.|||participants|||Number
2665744|NCT01529645|Primary|The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine|The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed and compared to that of licensed comparator in terms of the number of subjects reporting solicited local and systemic adverse events and other adverse events after vaccination.|Day 1 through 7 after vaccination|Analysis was done on the safety set, ie, all subjects who received the study vaccination and provided post vaccination safety data.|||participants|||Number
2665745|NCT01529632|Secondary|Change From Baseline in Percentage of Days With 'no Daytime Symptoms' Over 28 Days of Treatment|The mean total symptom scores and mean individual symptom scores for the patient were calculated for the whole study period. The mean change from baseline in the total scores and in the individual scores were summarized by treatment and were analyzed for the percentage of 'nights with no nighttime awakenings'. The symptom variables for the whole active treatment period was analyzed using the similar MIXED model as for the primary endpoint, with the baseline FEV1 term being replaced by the respective baseline symptom variables.|28 days|The Modified per protocol set (PPS) was defined post-DBL and included all patients with available data and without any major protocol deviations or criteria or GCP finding causing exclusion. Patients were analyzed according to the treatment to which they were randomized.|||percentage of days||Standard Deviation|Mean
2665756|NCT01529515|Secondary|Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase|The CGI-S rating scale is used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).|Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)|"Intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study agent. Missing data was imputed using LOCF method. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."|||Units on a Scale||Standard Deviation|Mean
2665746|NCT01529632|Secondary|Change From Baseline in the Mean Daily, (Daytime and Nighttime Combined) Number of Puffs of Rescue Medication Used Over 28 Days of Treatment|The number of puffs of rescue medication taken in the previous 12 hours was recorded in the Patient Diary in the morning and evening. The total number of puffs of rescue medication per day over the whole active treatment period was calculated and divided by the total number of days with non-missing rescue data to derive the mean daily number of puffs of rescue medication taken for the patient. If the number of puffs was missing for part of the day (either morning or evening) then a half day was used in the denominator.|Baseline and 28 days|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.~Patients were analyzed according to the treatment to which they were randomized."|||puffs||Standard Deviation|Mean
2665747|NCT01529632|Secondary|Time Course of Forced Expiratory Volume in One Second (FEV1) (Pre-dose to 4 Hours Post Dose) on Day 28|Time course of Forced Expiratory Volume in 1 second (FEV1) was measured at -45 min, -15 min predose, 5 min, 30 min, 1 hr, 2hr, 3hr and 4 hr post-dose on Day 28. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|-45 min, -15 min predose, 5 min, 30 min, 1 hr, 2hr, 3hr and 4 hr post-dose on Day 28|The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion. Patients were analyzed according to the treatment to which they were randomized.|||Liters||Standard Error|Least Squares Mean
2665748|NCT01529632|Secondary|Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 28 Post-dose|Spirometry was conducted according to internationally accepted standards. Peak FEV1 is the maximum FEV1 recorded in the period between 5 minutes and 4 hours post dose. Analysis of Covariance was carried out with a mixed model that used (period) baseline, defined as the value of FEV1 measured prior to the first study drug intake in the period, as a covariate.|5 min - 4 hr at Days 1 and 28|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.~Patients were analyzed according to the treatment to which they were randomized."|||Liters||Standard Error|Least Squares Mean
2665749|NCT01529632|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 28|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4h at Day 28 was measured via spirometry conducted according to internationally accepted standards. Measurements were made at 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. Mixed model used: AUC FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.|0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 28|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.~Patients were analyzed according to the treatment to which they were randomized."|||Liters||Standard Error|Least Squares Mean
2665750|NCT01529632|Secondary|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4 Hours at Day 1|Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-4h at Day 1 was measured via spirometry conducted according to internationally accepted standards. Measurements were made at 0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. Mixed model used: AUC FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.|0, 5, 15, and 30 minutes; and 1, 2, 3 and 4 hours post-dose at Day 1|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.~Patients were analyzed according to the treatment to which they were randomized."|||Liters||Standard Error|Least Squares Mean
2665751|NCT01529632|Primary|Trough Forced Expiratory Volume in 1 Second (FEV1) After 28 Days of Blinded Treatment|Spirometry was conducted according to internationally accepted standards. Trough FEV1 is defined as the average of the 23 hour 15 minute and 23 hour 45 minute post-dose FEV1 readings measured at day 29, after 28 days of treatment. Mixed model: Trough FEV1 = treatment + baseline FEV1 + FEV1 reversibility components + baseline smoking status + baseline ICS use + country + center (country) + error. Center was included as a random effect nested within country.|Day 29|"The Per Protocol Set includes the Full analysis Set patients with available data and without any major protocol deviations or criteria causing exclusion.~Patients were analyzed according to the treatment to which they were randomized."|||Liters||Standard Error|Least Squares Mean
2665752|NCT01529606|Primary|Restoration Failure Rate|Composite restoration evaluation for fracture or loss of filling partially or completely, with or without recurrent caries.|12 months|After 12 months, in standard care group, we had 27 participants remaining and lost 28 participants; in plasma treatment group, we had 21 participants remaining and lost 26 participants. Units of analysis for composite restoration failure is number of composite restorations in each group. A participant may have more than one composite restoration.|||composite fillings|composite fillings||Number
2665753|NCT01529606|Primary|Decayed and Filling Surfaces|Number of decayed and filling surfaces|12 months||||tooth surface||Standard Deviation|Mean
2665754|NCT01529606|Primary|Number of Decayed, Missing and Filling Teeth (DMFT)|Number of decayed, missing and filling teeth (DMFT) during 12 months|12 months|34 participants in standard care group and 29 in plasma group|||teeth||Standard Deviation|Mean
2665755|NCT01529515|Secondary|Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase|The PSP scale measures personal and social functioning in the domains of: a) Socially useful activities, b) Personal and social relationships, c) Self-care, and d) Disturbing and aggressive behavior. The results of the assessment were converted to a numerical score which ranges from 1 to 100. A score lying between 71 and 100 indicates a mild degree of dysfunction; scores between 31 and 70 indicate varying degrees of difficulty, and a participant with a score of <=30 had functioning so poor that he or she required intensive supervision.|Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)|"Intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study agent. Missing data was imputed using LOCF method. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."|||Units on a Scale||Standard Deviation|Mean
2665757|NCT01529515|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase|The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item is rated 1 (absent) to 7 (extreme). The total score ranging from 30 to 210. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia.|Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)|"Intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study agent. Missing data was imputed using LOCF method. Here N (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure."|||Units on a Scale||Standard Deviation|Mean
2665758|NCT01529515|Primary|Time to Relapse During the Double-Blind Phase|Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event. Median time to relapse was estimated by the Kaplan-Meier method.|Approximately Week 60|The intent-to-treat (ITT) double blind (DB) population included all participants who were randomly assigned to treatment during the Double-blind Phase and received at least one dose of Double-blind study agent.|||Days||95% Confidence Interval|Median
2665759|NCT01529502|Other Pre-specified|Endothelial Function|To assess Endothelial function by RHI at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|Before and after blood transfusion|||||||
2665760|NCT01529502|Other Pre-specified|Changes in Gene Expression|To assess concentration of changes in gene expression at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|Before and after blood transfusion|||||||
2665761|NCT01529502|Other Pre-specified|Activation of Inflammatory Lipid Mediators|To assess concentration of plasma activation of inflammatory lipid mediators at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|Before and after blood transfusion|||||||
2665762|NCT01529502|Other Pre-specified|Activation of Platelets|To assess concentration of plasma activation of platelets at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|Before and after blood transfusion|||||||
2665763|NCT01529502|Other Pre-specified|Concentration of Cytokines|To assess concentration of plasma cytokines at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|Before and after blood transfusion|||||||
2665764|NCT01529502|Other Pre-specified|Nitric Oxide Metabolites|To assess concentration of plasma Nitric oxide metabolites at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|Before and after blood transfusion|||||||
2665765|NCT01529502|Other Pre-specified|Hemolysis|To assess concentration of plasma Hemoglobin at baseline, 10 minutes after blood transfusion, 1 hour after blood transfusion, 2 hours after blood transfusion and 4 hours after blood transfusion.|before and after blood transfusion|||||||
2665766|NCT01529502|Secondary|Endothelial Function: Reactive Hyperemia Index|Reactive Hyperemia Index (RHI) measures Endothelial function and is assessed by digital pulse amplitude tonometry and it is a sensitive indicator of endothelial function. RHI is a calculated as a ratio between tested versus contralateral finger dilatation, thus there is no unit measure.|Post-transfusion||||LnRHI||Standard Error|Mean
2665767|NCT01529502|Primary|Systolic Pulmonary Artery Pressure|Pulmonary vasoconstriction was measured by estimation of Systolic Pulmonary Artery Pressure in millimeter of mercury (mmHg) by trans-thoracic echocardiography|Post-transfusion|"In the fresh blood only 9 volunteers estimation of Systolic Pulmonary Artery Pressure was successfully studied by trans-thoracic echocardiography. In the old blood only 11 volunteers and In the old blood + Inhaled Nitric Oxide only 12 volunteers estimation of Systolic Pulmonary Artery Pressure was successfully evaluated."|||mmHg||Standard Error|Mean
2665768|NCT01529450|Secondary|Molecular Markers Associated With Clinical Response|Following consent, historical biopsy samples were analyzed for molecular markers associated with clinical response. Tumors were analyzed and present of Smooth mutation (SMO [genetic changes which influence Ki 67 and Gli levels]). was determined. The number of participants with and without SMO were reported by clinical outcome (SD = stable disease; PD = progressive disease).|Assessed on day 1|Participants with tissue available for screening were analyzed.|||participants|||Number
2665769|NCT01529450|Primary|Progression Free Survival (PFS) of All Participants||End of treatment or at time of disease progression (up to 58 weeks)|Progression is defined using RECIST version 1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion or the appearance of new lesion.|||weeks||95% Confidence Interval|Median
2665770|NCT01529385|Primary|Microcirculation for Dorsum of Foot|microcirculation as measured by skin perfusion pressure|change from baseline after 4 weeks of sock usage||||mmHg||95% Confidence Interval|Mean
2665771|NCT01529385|Primary|Microcirculation for Lateral Calf|microcirculation as measured by skin perfusion pressure|change from baseline after 4 weeks of sock usage||||mmHg||95% Confidence Interval|Mean
2665772|NCT01529385|Primary|Microcirculation for Medial Calf|microcirculation as measured by skin perfusion pressure|change from baseline after 4 weeks of sock usage||||mmHg||95% Confidence Interval|Mean
2665773|NCT01529385|Secondary|Physical Activity Level|Physical activity monitors will be used to assess physical activity patters of participants for 48 hours prior to initiating sock usage and for 48 hours after the participants have worn the socks for four weeks.|baseline and after four weeks of wearing the socks|physical activity measurements were only made for a sub-sample of the study's complete sample|||steps||Standard Deviation|Mean
2665774|NCT01529385|Primary|Foot Edema|The circumference of the foot was measured by a tape measure.|change from baseline after 4 weeks of sock usage||||cm||95% Confidence Interval|Mean
2665775|NCT01529385|Primary|Ankle Brachial Index|ratio of systolic blood pressure of ankle relative to systolic blood pressure of arm|change from baseline after 4 weeks of sock usage||||unit-less ratio data||95% Confidence Interval|Mean
2665776|NCT01529385|Primary|Toe Brachial Index|ratio of systolic blood pressure of toe relative to systolic blood pressure of arm|change from baseline after 4 weeks of sock usage||||unit-less ratio data||95% Confidence Interval|Mean
2665780|NCT01529346|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities|Clinically significant ECG abnormalities: PR interval >=300 milliseconds (msec); 25% increase from baseline in PR interval when baseline PR was >200 msec; an increase from baseline of >=50% in PR interval when baseline PR was <=200 msec; QRS interval >=140 msec; an increase from baseline of >=50% in QRS interval; corrected QT interval (QTc) >=500 msec.|Baseline up to Day 7 to 10 (follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
2665781|NCT01529346|Secondary|Number of Participants With Clinically Significant Vital Signs|Clinically significant vital signs: supine/sitting pulse rate (PR) less than (<) 40 or more than (>) 120 beats per minute (bpm), standing PR <40 or >140 bpm; systolic blood pressure (BP) >=30 millimeters of mercury (mmHg) change from baseline; absolute systolic BP <90 mmHg; diastolic BP >=20 mmHg change from baseline; absolute systolic BP <50 mmHg.|Baseline up to Day 7 to 10 (follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
2665782|NCT01529346|Secondary|Number of Participants With Clinically Significant Laboratory Findings|Hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes), blood chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, creatinine, blood urea nitrogen, fasting glucose, uric acid, sodium, potassium, chloride, bicarbonate, calcium, albumin, total protein, creatine kinase), and urinalysis (urine white blood cells, urine red blood cells) were performed.|Baseline up to Day 7 to 10 (follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
2665783|NCT01529346|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to 28 days that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Day 28 (follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
2665784|NCT01529346|Secondary|Plasma Ibuprofen Concentration|Ibuprofen concentration was reported separately for 2 isomers of ibuprofen: (S)-Ibuprofen, and (R)-Ibuprofen, where S implied sinister (clockwise configuration) and R implied rectus (anti-clockwise configuration).|0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose|Pharmacokinetic analysis set included all randomized participants who received study treatment and had a pharmacokinetic sample analyzed within the treatment period.|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2665785|NCT01529346|Secondary|Plasma PF-05089771 Concentration||0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose|Pharmacokinetic analysis set included all randomized participants who received study treatment and had a pharmacokinetic sample analyzed within the treatment period.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2665786|NCT01529346|Secondary|Number of Participants With Study Medication Satisfaction|Participants provided assessment regarding satisfaction with study medication (SM) for pain relief (PR) and overall performance (OP) on a 5-point categorical scale, 1=very dissatisfied (VD), 2=somewhat dissatisfied (SD), 3=neither satisfied nor dissatisfied (NSND), 4=somewhat satisfied (SS) and 5=very satisfied (VS).|6, 24 hours, prior to rescue medication (assessed up to 24 hours)|FAS: all randomized participants who received >=1 dose of study treatment, had >=1 evaluable (>=90 minutes post-dose) PR score. Participants who received RM prior to 90 minutes were not included in FAS. N(number of participants analyzed): participants evaluable for this measure.|||participants|||Number
2665787|NCT01529346|Secondary|Number of Participants With Global Evaluation of Study Medication|Participant rated the study medication at 6 hours, 24 hours and immediately prior to rescue medication intake (only for participants who took rescue medication[RM]), on 5-point categorical scale: 1=poor, 2=fair, 3=good, 4=very good, and 5=excellent.|6, 24 hours, prior to rescue medication (assessed up to 24 hours)|FAS: all randomized participants who received >=1 dose of study treatment, had >=1 evaluable (>=90 minutes post-dose) PR score. Participants who received RM prior to 90 minutes were not included in FAS. N(number of participants analyzed): participants evaluable for this measure.|||participants|||Number
2665788|NCT01529346|Secondary|Time to First Use of Rescue Medication|Time to first use of rescue medication (acetaminophen 500 mg or hydrocodone 5 mg) was calculated by subtracting time of first administration of study medication from the rescue medication administration time.|0 to 24 hours|FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Participants who received rescue medication prior to 90 minutes were not included in FAS.|||hours||90% Confidence Interval|Median
2665789|NCT01529346|Secondary|Time to Onset of Meaningful Pain Relief|Participants evaluated the time to first meaningful relief by stopping a stopwatch labeled 'meaningful pain relief' at the moment they first began to experience meaningful relief.|0 to 24 hours|FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Participants who received rescue medication prior to 90 minutes were not included in FAS.|||hours||90% Confidence Interval|Median
2665790|NCT01529346|Secondary|Time to Onset of First Perceptible Pain Relief|Participants evaluated the time to first perceptible pain relief by stopping a stopwatch labeled 'first perceptible pain relief' at the moment they first began to experience any relief.|0 to 24 hours|FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Participants who received rescue medication prior to 90 minutes were not included in FAS.|||hours||90% Confidence Interval|Median
2665824|NCT01529203|Primary|Subject Satisfaction for the Full Face|based on the subject's satisfaction questionnaire|Month 6|only the 56 subjects who had provided answers in the subject's satisfaction questionnaire were included in the analysis|||percentage of total subjects|||Number
2666560|NCT01522456|Other Pre-specified|User Preference Survey (Subjects)|"Response from subjects when asked: Which side of the face feels less irritated? Data collected from available participants on each assessment day."|Day 5, day 12, day 19, and day 22|Safety population|||participants|||Number
2665791|NCT01529346|Secondary|Total Pain Relief From 0 to 24 Hours (TOTPAR[24])|TOTPAR(24) was defined as the total area under the PR curve through the first 24 hours after dosing, calculated using trapezoidal rule. PR was assumed to be 0 at 0 hour. PR assessed on a 5-point categorical scale: 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at different time points during the study up to 6 hours. Total score range for TOTPAR (24): 0 (worst) to 96 (best), higher value indicated greater degree of PR. The least square mean and standard error are based on ANCOVA model with treatment as a fixed effect and baseline pain intensity as a covariate|0 to 24 hours|FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Analysis excluded influential outliers. Participants who received rescue medication prior to 90 minutes were not included in FAS. Missing data were imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
2665792|NCT01529346|Secondary|Summed Pain Intensity Difference (SPID)|SPID: area under the PID effect curve from 0 to 6 hours (SPID[6]) and 0 to 24 hours (SPID[24]). AUC was calculated using the trapezoidal rule. Total score range: -6 (worst) to 18 (best) for SPID(6), and -24 (worst) to 72 (best) for SPID(24). Higher value of SPID indicated greater degree of pain relief. PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe).|0 to 6 hours; 0 to 24 hours|FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Analysis excluded influential outliers. Participants who received rescue medication prior to 90 minutes were not included in FAS. Missing data were imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
2665793|NCT01529346|Secondary|Pain Intensity Difference (PID)|PID was calculated as pain intensity at baseline (baseline pain severity score range 2 [moderate] to 3 [severe]) minus pain intensity at the respective post-baseline visit (pain severity score range 0 [none] to 3 [severe]). Total possible score range for PID: -1 (worst) to 3 (best).|15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours|FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Analysis excluded influential outliers. Participants who received rescue medication prior to 90 minutes were not included in FAS.|||units on a scale||Standard Error|Least Squares Mean
2665794|NCT01529346|Secondary|Pain Relief (PR) Score|PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).|15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours|FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Analysis excluded influential outliers. Participants who received rescue medication prior to 90 minutes were not included in FAS.|||units on a scale||Standard Error|Least Squares Mean
2665795|NCT01529346|Secondary|Number of Participants With Peak Pain Relief (PPR)|PPR was defined as the highest PR score achieved at any time point during the evaluation period, prior to rescue medication. PR was assessed on a 5-point categorical scale: 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).|0 to 24 hours|FAS included all randomized participants who received >=1 dose of study treatment and had >=1 evaluable (>=90 minutes post-dose) pain relief score. Participants who received rescue medication prior to 90 minutes were not included in FAS.|||participants|||Number
2665796|NCT01529346|Primary|Total Pain Relief From 0 to 6 Hours (TOTPAR[6])|TOTPAR(6) was defined as the total area under pain relief (PR) curve through first 6 hours after dosing, calculated using trapezoidal rule. PR was assumed to be 0 at 0 hour. PR assessed on a 5-point categorical scale: 0(none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at different time points during study up to 6 hours. Total score range for TOTPAR(6): 0 (worst) to 24 (best), higher value indicated greater degree of PR. Posterior mean, standard deviation were estimated based on analysis of covariance (ANCOVA) model with non-informative priors within outlier robust Bayesian framework.|0 to 6 hours|Full Analysis Set (FAS): all randomized participants who received at least (>=) 1 dose of study treatment and had >=1 evaluable (more than or equal to [>=] 90 minutes post-dose) PR score. Participants who received rescue medication prior to 90 minutes were not included in FAS. Missing data were imputed using Last Observation Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
2665797|NCT01529268|Secondary|Reduction in MRI-determined Hepatic Fat Fraction|Change from baseline in MRI Proton Density Fat Fraction (PDFF) (%).|52 weeks|The smaller number of observations is because MRI was an optional procedure. This is the number with MRI exams at both baseline and 52 weeks.|||percentage of PDFF||Standard Deviation|Mean
2665798|NCT01529268|Secondary|Change in Pediatric Quality of Life Inventory (PedsQL) Score|Pediatric Quality of Life Inventory (PedsQL) version 4.0 is completed by both the child and parent/caregiver, and is composed of 23 items comprising 4 dimensions: Physical Functioning, Emotional Functioning, Social Functioning, and School Functioning. Scores are transformed on a scale from 0 to 100, with higher scores indicating better health-related quality of life. Physical Health Summary Score =Physical Functioning Scale Score. Psychosocial Health Summary Score = Sum of items over the number of items answered in the Emotional, Social, and School Functioning Scales.|52 weeks||||units on a scale||Standard Deviation|Mean
2665799|NCT01529268|Secondary|Change in Diastolic Blood Pressure||52 weeks||||mmHg||Standard Deviation|Mean
2665800|NCT01529268|Secondary|Change in Systolic Blood Pressure||52 weeks||||mmHg||Standard Deviation|Mean
2665801|NCT01529268|Secondary|Change in HOMA-IR|(Glucose (mmol/L) x insulin (pmol/L))/22.5|52 weeks||||(10E-15 mol^2)/L^2||Standard Deviation|Mean
2665802|NCT01529268|Secondary|Change in Fasting Insulin||52 weeks||||μU/mL||Standard Deviation|Mean
2665803|NCT01529268|Secondary|Change in Fasting Serum Glucose||52 weeks||||mg/dL||Standard Deviation|Mean
2665804|NCT01529268|Secondary|Change in Waist Circumference||52 weeks||||cm||Standard Deviation|Mean
2665805|NCT01529268|Secondary|Change in Body-mass Index Z-score||52 weeks||||SD||Standard Deviation|Mean
2665806|NCT01529268|Secondary|Change in Body-mass Index||52 weeks||||kg/m^2||Standard Deviation|Mean
2665807|NCT01529268|Secondary|Change in Weight (kg)||52 weeks|Smaller number of patients analyzed due to missing 52-week weight measurement.|||kg||Standard Deviation|Mean
2665808|NCT01529268|Secondary|Change in Serum Aminotransferase and Gamma-glutamyl Transpeptidase||52 weeks|The smaller number of participants analyzed is due to missing 52-week laboratory data.|||U/L||Standard Deviation|Mean
2665810|NCT01529268|Secondary|Fibrosis: Change in Stage|Change from baseline in fibrosis stage. The amount of fibrosis is based on central pathologist grading of liver biopsies: 0=none; 1a=mild, zone 3 perisinusoidal, 1b=moderate, zone 3, perisinusoidal, 1c=portal/periportal only, 2=zone 3 and periportal, any combination, 3=bridging, 4=cirrhosis. Fibrosis stages 1a, 1b, 1c recoded as 1, so the possible range of values for fibrosis stage was 0-4. Change in fibrosis stage has a possible range of -4 to +4, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement).|52 weeks|The smaller number of participants analyzed is due to missing 52-week biopsies (complete case analysis).|||units on a scale||Standard Deviation|Mean
2665811|NCT01529268|Secondary|Fibrosis: Patients With Improvement|Improvement in fibrosis stage defined as any decrease in fibrosis stage comparing 52-week biopsy to baseline.|52 weeks|Analysis based on intention to treat; patients with missing 52-week biopsy were imputed as lack of improvement.|||participants|||Number
2665812|NCT01529268|Secondary|Portal Inflammation: Change in Score|Change from baseline in portal inflammation score. The amount of portal inflammation is based on central pathologist grading of liver biopsies: 0=none; 1=mild, 2=more than mild. Change in portal inflammation score has a possible range of -2 to +2, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement).|52 weeks|The smaller number of participants analyzed is due to missing 52-week biopsies (complete case analysis).|||units on a scale||Standard Deviation|Mean
2665813|NCT01529268|Secondary|Portal Inflammation: Patients With Improvement|Improvement in portal inflammation defined as any decrease in portal inflammation score comparing 52-week biopsy to baseline.|52 weeks|Analysis based on intention to treat; patients with missing 52-week biopsy were imputed as lack of improvement.|||participants|||Number
2665814|NCT01529268|Secondary|Hepatocellular Ballooning: Change in Score|Change from baseline in hepatocellular ballooning score. The amount of hepatocellular ballooning is based on central pathologist grading of liver biopsies: 0=none; 1=few ballooned hepatocytes, 2=many ballooned hepatocytes. Change in hepatocellular ballooning score has a possible range of -2 to +2, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement).|52 weeks|The smaller number of participants analyzed is due to missing 52-week biopsies (complete case analysis).|||units on a scale||Standard Deviation|Mean
2665815|NCT01529268|Secondary|Hepatocellular Ballooning: Patients With Improvement|Improvement in hepatocellular ballooning defined as any decrease in hepatocellular ballooning score comparing 52-week biopsy to baseline.|52 weeks|Analysis based on intention to treat; patients with missing 52-week biopsy were imputed as lack of improvement.|||participants|||Number
2665816|NCT01529268|Secondary|Lobular Inflammation: Change in Score|Change from baseline in lobular inflammation score. The amount of lobular inflammation is based on central pathologist grading of liver biopsies, and combines mononuclear, fat granulomas, and polymorphonuclear (pmn) foci: 0=none; 1=<2 under 20x magnification, 2=2-4 under 20x magnification, 3=>4 under 20x magnification. Change in lobular inflammation score has a possible range of -3 to +3, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement).|52 weeks|The smaller number of participants analyzed is due to missing 52-week biopsies (complete case analysis).|||units on a scale||Standard Deviation|Mean
2665817|NCT01529268|Secondary|Lobular Inflammation: Patients With Improvement|Improvement in lobular inflammation defined as any decrease in lobular inflammation grade comparing 52-week biopsy to baseline.|52 weeks|Analysis based on intention to treat; patients with missing 52-week biopsy were imputed as lack of improvement.|||participants|||Number
2665818|NCT01529268|Secondary|Steatosis: Change in Score|Change from baseline in steatosis score. Steatosis score is based on central pathologist grading of liver biopsies: 0=<5% steatosis; 1=5-33% steatosis, 2=34-66% steatosis, 3=>66% steatosis. Change in steatosis score has a possible range of -3 to +3, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome (no improvement).|52 weeks|The smaller number of participants analyzed is due to missing 52-week biopsies (complete case analysis).|||units on a scale||Standard Deviation|Mean
2665819|NCT01529268|Secondary|Steatosis: Patients With Improvement|Improvement in steatosis defined as any decrease in steatosis grade comparing 52-week biopsy to baseline.|52 weeks|Analysis based on intention to treat; patients with missing 52-week biopsy were imputed as lack of improvement.|||participants|||Number
2665820|NCT01529268|Secondary|Change in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)|Change from baseline in the NAFLD Activity Score (NAS), which is a composite score equal to the sum of the steatosis grade (0-3), lobular inflammation grade (0-3), and hepatocellular ballooning grade (0-2), from centralized pathologist scoring of liver biopsies. The overall scale of the NAS is 0-8, with higher scores indicating more severe disease. The outcome measure, change from baseline in NAFLD Activity Score (NAS), has a possible range from -8 to +8, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. Components of the NAS are scored as follows: Steatosis grade 0=<5% steatosis, 1=5-33% steatosis, 2=34-66% steatosis, 3=>66% steatosis. Lobular inflammation grade=amount of lobular inflammation (combines mononuclear, fat granulomas, and polymorphonuclear (pmn) foci): 0=0, 1=<2 under 20x magnification, 2=2-4 under 20x magnification, 3=>4 under 20x magnification. Hepatocellular ballooning 0=none, 1=mild, 2=more than mild.|52 weeks|The smaller number of participants analyzed is due to missing 52-week biopsies (complete case analysis).|||units on a scale||Standard Deviation|Mean
2665821|NCT01529268|Primary|Improvement in Nonalcoholic Fatty Liver Disease (NAFLD)|Centrally scored and masked assessment of histologic improvement in Nonalcholic Fatty Liver Disease (NAFLD) between the baseline liver biopsy and follow-up biopsy after 52 weeks of treatment, where improvement is defined as: (1) decrease in the NAFLD Activity Score (NAS) of 2 or more and (2) no worsening of fibrosis.|52 weeks|Analysis based on intention to treat; patients with missing 52-week biopsy were imputed as lack of improvement.|||participants|||Number
2665822|NCT01529203|Secondary|Related Adverse Event|Number of subjects reporting related adverse events|Month 6||||participants|||Number
2665823|NCT01529203|Secondary|Global Aesthetic Improvement From Baseline|"The scale responses are: -1 indicating worse, 0 indicating no change, 1 indicating improved, 2 indicating much improved and 3 indicating very much improved."|Week 3||||percentage of total subjects|||Number
2667773|NCT01512225|Secondary|Increase in Breast Milk Volume on Day 28|Number of mothers who achieved 50% increase in milk volume on day 28|day 0 to day 28||||Participants|||Count of Participants
2665825|NCT01529112|Secondary|Pharmacokinetic (PK) Profile of Lenvatinib in Subjects With Non Small Cell Lung Cancer (NSCLC)|Blood samples were collected for lenvatinib PK analysis. Lenvatinib concentrations from sparse PK sampling were measured. The data is presented as mean nanograms per milliliter +/- Standard deviation of lenvatinib serum concentration.|Cycle 1/Day 1 (between 0.5 and 4 hours postdose and 6 and 10 hours postdose), Cycle 1/Day 15 (predose, between 0.5 and 4 hours postdose, and 6 and 10 hours postdose), and Day 1 of Cycles 2 though 4 (predose and between 2 and 12 hours postdose)|The analysis was performed using the pharmacokinetic (PK) analysis set defined as all subjects who received at least one dose of study drug and had evaluable PK data.|||nanograms per milliliter||Standard Deviation|Mean
2665826|NCT01529112|Secondary|The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) Module QLQ-LC13 (Lung Cancer 13) Symptom Scores Achieving Clinically Significant Deterioration on QOL|The EORTC module QLQ-LC13 symptom score was a self-reporting cancer-specific questionnaire composed of 13 questions incorporated into 1 multi-item scale designed to evaluate dyspnea and a series of single items assessing different types of pain, as well as, cough, hemoptysis, dysphagia, sore mouth, alopecia, and peripheral neuropathy. For each domain and item, a linear transformation was applied to standardize the raw score to a range from 0 to 100, with 100 representing the best possible function/QOL, and highest burden of symptoms for symptom domains and single items. The data is presented as percentage of participants with EORTC module QLQ-C13 symptom score achieving clinically significant deterioration on QOL. Participants were considered as deteriorated for a given symptom if the change in score from Baseline was 10 points or higher at any time point after Baseline. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|Baseline (Day 1 of Cycle 1 (prior to treatment in Cycle 1)), every 4 weeks during treatment, and 4 weeks after completing treatment or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.|||Percentage of participants|||Number
2665827|NCT01529112|Secondary|The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Symptom Scores Achieving Clinically Significant Deterioration on Quality of Life (QOL)|The EORTC QLQ-C30 symptom score, a cancer specific self-reporting questionnaire was composed of 9-symptom scales assessing fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. All of the multi-item scales and single-item measures ranged in score from 0 to 100. For each domain and item, a linear transformation was applied to standardize the raw score to a range from 0 to 100, with a higher scale score representing a higher response level/ high level of symptomatology / problems. The data is presented as percentage of participants with EORTC QLQ-C30 symptom score achieving clinically significant deterioration on QOL. Participants were considered as deteriorated for a given symptom if the change in score from Baseline was 10 points or higher at any time point after Baseline. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|Baseline (Day 1 of Cycle 1 (prior to treatment in Cycle 1)), every 4 weeks during treatment, and 4 weeks after completing treatment or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.|||Percentage of participants|||Number
2665828|NCT01529112|Secondary|Disease Control Rate (DCR)|The percentage of participants with CR, PR, or stable disease (SD) for greater than or equal to 12 weeks. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on the study. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.|||Percentage of Participants||95% Confidence Interval|Number
2665829|NCT01529112|Secondary|Response Duration (RD)|Response duration, defined as the time from the date of the first assessment demonstrating a CR or PR to the date of the first assessment demonstrating progressive disease or death, whichever occurred first. This is an investigator assessed outcome, measured using RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Response duration was summarized by including only subjects with events. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using subjects with events.|||Weeks||95% Confidence Interval|Median
2665830|NCT01529112|Primary|Overall Survival (OS)|OS was defined as the time from the date of randomization until the date of death from any cause.|From date of randomization (Day 1) until occurrence of 90 deaths in the study (cut off date 26 November 2013), approximately 22 months|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.|||weeks||95% Confidence Interval|Median
2665831|NCT01529112|Secondary|Overall Response Rate (ORR)|ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator using RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.|||Percentage of Participants||95% Confidence Interval|Number
2665832|NCT01529112|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of the randomization until the date of first documented disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 or date of death from any cause (whichever occurred first), assessed based on investigator's assessment. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.|From date of randomization (Day 1) until date of first documentation of disease progression or death from any cause (whichever occurred first) or up to approximately 2 years (data cut-off date of 21 January 2014)|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.|||weeks||95% Confidence Interval|Median
2665833|NCT01529112|Secondary|1-year Survival Rate|Event-free survival rate was calculated using Kaplan Meier estimations. The percentage of participants with event free survival up to 1 year and the corresponding 95% confidence interval were estimated for each treatment group. The data presented is based on the data cut-off date of 26 November 2013 while the study is still ongoing.|From date of randomization (Day 1) up to 1 year|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.|||Percentage of Participants||95% Confidence Interval|Number
2665834|NCT01529112|Secondary|6-Month Survival Rate|Event-free survival rate was calculated using Kaplan Meier estimations. The percentage of participants with event free survival up to 6 months and the corresponding 95% confidence interval were estimated for each treatment group. The data presented is based on the data cut-off date of 26 November 2013 while the study is still ongoing.|From date of randomization (Day 1) up to 6 months|The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.|||Percentage of Participants||95% Confidence Interval|Number
2665835|NCT01529112|Secondary|Number of Participants With Treatment Emergent Non-serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A SAE was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (i.e., the subject was at a risk of death at the time of the event; this did not include an event that hypothetically might have caused death if it had been more severe), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, or was a congenital abnormality/birth defect. In this study, treatment emergent adverse events (TEAEs) (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.|For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)|Safety was analyzed in Safety Analysis Set defined as all subjects enrolled and randomized to treatment in study, except for those who (i) dropped out prior to receiving any study drug, or (ii) were without any safety assessment following the first dose of study drug.|||Participants|||Number
2665836|NCT01529060|Primary|Leucine CMax 0-24 Hours|Maximal leucine concentration in 0-24 hours|24 hours||||Micromoles/L||Standard Deviation|Mean
2665837|NCT01529060|Primary|0-24 Hour AUC Leucine (Samples Collected at 0, 2, 4, 8, 12, 16, 20, and 24 Hours)|Total Leucine exposure over 24 hours was calculated by serial blood draws at times 0, 2, 4, 8, 12, 16, 20, and 24 hours|24 Hours||||micromoles*hour/L||Standard Deviation|Mean
2665838|NCT01529034|Secondary|Number of Treated Seizure Clusters Meeting Criteria for Treatment Success|Number of Treated Seizure Clusters Meeting Criteria for Treatment Success: Termination of seizure(s) within 10 minutes and no recurrence within 6 hours after administration of first dose of USL261 (intranasal midazolam 5 mg)|6 hours after first dose of USL261 for each treated seizure cluster|Seizure cluster episodes treated with first dose of USL261|||Seizure cluster episodes|Seizure cluster episodes||Count of Units
2665839|NCT01529034|Primary|Emergency Room/Emergency Medical Service Visits|Participants requiring emergency room (ER)/emergency medical service (EMS) visit within 24 hours after any USL261 treated seizure cluster (including for continued seizures)|From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.|Participants who received at least 1 dose of USL261 5 mg on study|||Participants|||Count of Participants
2665840|NCT01529034|Primary|Participants With Suicidal Ideation|Participants with suicidal ideation reported on Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire at any post-baseline visit. Responses including: Wish to be Dead; Non-Specific Active Suicidal Thoughts; Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Active Suicidal Ideation with Specific Plan and Intent; and Any Suicidal Ideation Regardless of Type.|From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.|Participants who received at least 1 dose of USL261 5 mg on study|||Participants|||Count of Participants
2665841|NCT01529034|Primary|Participant Change in B-SIT Score|Change in participant Brief Smell Identification Test (B-SIT) score from baseline to last visit with assessment. The B-SIT is a self-administered 12-item test; the score indicates odors correctly identified (0 to 12). The B-SIT was added while the study was already ongoing (Protocol Amendment 4, 20 May 2015) in response to a regulatory request. The test was only implemented at sites in the United States and included only participants considered by the investigator to have adequate cognitive ability to perform the test. Baseline was defined as the latest non-missing value prior to administration of USL261 in the Test Dose Phase of Study P261-401.|From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.|Participants who received at least 1 dose of USL261 5 mg on study, had a baseline B-SIT in Study P261-401, and a post-baseline B-SIT in Study P261-402.|||score on a scale||Standard Deviation|Mean
2665842|NCT01529034|Primary|Participants With Clinically Significant Abnormalities on Nasal Examination|Participants with abnormal findings, at any time post baseline, on nasal examination considered clinically significant by the investigator|From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.|Participants who received at least 1 dose of USL261 5 mg on study|||Participants|||Count of Participants
2668318|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Mean Percentage Error)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)|study day 1|Final population for data analysis|||percentage error||Standard Deviation|Mean
2665843|NCT01529034|Primary|Participants With Clinically Significant Abnormalities on Neurologic Examination|Participants with abnormal findings, at any time post baseline, on neurologic examination considered clinically significant by the investigator|From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.|Participants who received at least 1 dose of USL261 5 mg on study|||Participants|||Count of Participants
2665844|NCT01529034|Primary|Participants With Clinically Significant Abnormalities Physical Examination|Participants with abnormal findings, at any time post baseline, on physical examination considered clinically significant by the investigator.|From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.|Participants who received at least 1 dose of USL261 5 mg on study|||Participants|||Count of Participants
2665845|NCT01529034|Primary|Participants With Laboratory Abnormalities Meeting Predefined Criteria|Participants with abnormal laboratory finding, at any time post baseline, meeting predefined criteria. Abnormal laboratory findings were assessed separately by investigator and recorded as adverse events if applicable. Alanine aminotransferase (ALT); Alkaline phosphatase (ALP); Aspartate aminotransferase (AST); Gamma glutamyl transferase (GGT); upper limit of normal (ULN)|From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.|Participants who received at least 1 dose of USL261 5 mg on study|||Participants|||Count of Participants
2665846|NCT01529034|Primary|Participants Meeting Predefined Safety Criteria for Vital Signs|Participants meeting predefined safety criteria for vital signs (systolic blood pressure [SBP] <85 mm Hg, SBP change from baseline >/= 40 mm Hg, diastolic BP [DBP] <50 mm Hg, DBP change from baseline >/=30 mm Hg, pulse rate <50 beats per minute (bpm), pulse rate >120 bpm, pulse rate change >/= 40 bpm at any visit post baseline or for caregiver recorded participant respiration rate [RR] <8 breaths per minute (brpm) or >24 brpm) after any USL261 treated seizure cluster episode. Abnormal vital signs were assessed separately by investigator and recorded as adverse events if applicable.|From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.|Participants who received at least 1 dose of USL261 5 mg on study|||Participants|||Count of Participants
2665847|NCT01529034|Primary|Duration of Safety Observation|Duration of participant study participation for collection of long term safety data|From Baseline/(Screening) to End of Safety-Follow-up (up to 56 months) as per assessment table of the study.|Participants who received at least 1 dose of USL261 5mg on study|||months||Full Range|Median
2665848|NCT01528969|Secondary|The Changes in the Counts of the 14 Other Bacterial Species|The bacterial species were measured from stimulated saliva at the beginning and after the intervention|5 weeks|||||||
2665849|NCT01528969|Primary|MS Counts of Stimulated Saliva|The MS counts were measured at the beginning and in the end of the 5 weeks intervention|5 weeks||||MS counts log CFU/ml||Standard Deviation|Mean
2665850|NCT01528891|Primary|Diastolic Blood Pressure (DBP)|"mmHg~Three subjects with missing data points for DBP were necessarily eliminated from repeated measures analysis."|Diastolic blood pressure (DBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. DBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).|Diastolic blood pressure values were compared between groups at each time point and within groups over time.|||mmHg||Standard Deviation|Mean
2665851|NCT01528891|Primary|Systolic Blood Pressure (SBP)|"mmHg~Two subjects with missing data points for SBP were necessarily eliminated from repeated measures analysis."|Systolic blood pressure (SBP) was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. SBP was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).|Systolic blood pressure values were compared between groups at each time point and within groups over time.|||mmHg||Standard Deviation|Mean
2665852|NCT01528891|Secondary|Incidence of Emergence Agitation (EA)|Using a Pediatric Anesthesia Emergence Delirium (PAED) score, emergence agitation scores will be recorded. The PAED score consists of 5 different criteria which are assessed from 0 to 4 once the patient has woken up. These criteria are then totaled; the total may range from 0 to 20, where 0 represents no emergence agitation and 20 represents maximal agitation. For this study, patients with a maximum PAED score of >10 and >12 were considered to be agitated.|The highest PAED score for each patient within the first 30 minutes after waking up was recorded.|There were 2 patients in the Dexmedetomidine group and 9 patients in the placebo group who were excluded from analysis of emergence agitation. These patients were excluded because they received medications that were not a part of the anesthetic protocol and could affect their PAED score.|||percentage of patients with EA|||Number
2665853|NCT01528891|Primary|Heart Rate (HR)|beats per minute (bpm)|Heart rate was measured immediately prior to study drug injection (baseline) and every minute thereafter for 5 minutes. Heart rate was also measured upon the patient's arrival to the Post-Anesthesia Care Unit (PACU).|Heart rate values were compared between groups at each time point and within groups over time.|||bpm||Standard Deviation|Mean
2665854|NCT01528878|Secondary|Overall Survival of Patients With Liver Cancer or Metastases to the Liver|Overall survival is defined as percentage of patients remaining alive from start of study treatment to 1 year.|1 year||||percentage of participants|||Number
2665855|NCT01528878|Secondary|Percentage of Local Response to Doses of Radiation in Patients With Liver Cancer or Metastases to the Liver|Complete response (CR) is defined as disappearance of the target lesion, partial response (PR) as regression of measureable disease, progressive disease (PD) as increase by >= 50% in product of the two perpendicular diameters of an irradiated lesion, and stable disease (SD) as all others not meeting criteria for CR, PR, or PD.|6 months||||percentage of participants|||Number
2665856|NCT01528878|Secondary|Local Tumor Control to Doses of Radiation in Patients With Liver Cancer or Metastases to the Liver|1 year local control defined as percentage of patients with freedom from local progression at a median follow-up time of 12.7 months. Progressive disease is defined as increase by >= 50% of product of the two perpendicular diameters of an irradiated lesion.|12.7 months||||percentage of participants|||Number
2665899|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of Faldaprevir|Maximum measured concentration of Faldaprevir (BI 201335 ZW) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2665857|NCT01528878|Primary|Tolerability of Stereotactic Body Radiotherapy (SBRT) Based on Number of Cumulative Acute Toxicities Occurring Within 90 Days of Treatment and Related to SBRT.|To determine a tolerable dose, cumulative acute toxicity was collected (defined as toxicity occurring within 90 days of treatment initiation). Adverse events were graded by the Common Terminology Criteria for Adverse Events version 3.0. Tolerability was based on hepatic toxicity. A grading (severity) scale is provided for each adverse event (AE) term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.|90 days||||Participants|||Count of Participants
2665858|NCT01528787|Primary|Intraocular Pressure (IOP)|"The primary efficacy outcome was the mean IOP across subjects within treatment group at each post-treatment timepoint of Day 8.~Instillation of study treatment commenced on Day 2 following measurement of IOP. IOP was measured at 0800, 1000, 1200 and 1600 hours on days 2 and 8. IOP was also measured at 0800 hours on Day 4."|Study treatment was administered for 7 days; starting on Day 2 and ending on Day 8.|Modified intent to treat (mITT) population (85 patients receiving investigational treatment). Participants who did not complete the study did not contribute data at later time points.|||mmHg||Standard Deviation|Mean
2665859|NCT01528735|Secondary|Predose Measured Concentration of RBV|Predose measured concentration of ribavirin (RBV) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2665860|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of RBV|"Mean residence time of ribavirin (RBV) in the body after oral administration at steady state (MRTpo,ss).~This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||||||
2665861|NCT01528735|Secondary|Cmax Accumulation Ratio (RA,Cmax,57) of RBV|Accumulation ratio of ribavirin (RBV) in plasma after the administration of the 57th day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the 57th day and after the first dose (RA,Cmax,57).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2665862|NCT01528735|Secondary|AUC Accumulation Ratio of RBV|Accumulation ratio of ribavirin (RBV) in plasma after the administration of the 57th day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the 57th day and after the first dose (RA,AUC,57).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2665863|NCT01528735|Secondary|Predose Measured Concentration of CD 6168-AG|Predose measured concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2665864|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of CD 6168-AG|"Mean residence time of CD 6168-AG (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss). AG=acylglucuronide.~This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||||||
2665865|NCT01528735|Secondary|AUC Accumulation Ratio of CD 6168-AG|Accumulation ratio of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of CD 6168-AG versus AUC,ss of Deleobuvir (RA,AUC,Met,ss). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2665866|NCT01528735|Secondary|Cmax Accumulation Ratio of CD 6168-AG|Accumulation ratio of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of CD 6168-AG versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2665867|NCT01528735|Secondary|Predose Measured Concentration of CD 6168|Predose measured concentration of CD 6168 (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2665868|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of CD 6168|"Mean residence time of CD 6168 (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).~This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||||||
2665869|NCT01528735|Secondary|AUC Accumulation Ratio of CD 6168|Accumulation ratio of CD 6168 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of CD 6168 versus AUC,ss of Deleobuvir (RA,AUC,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2665870|NCT01528735|Secondary|Cmax Accumulation Ratio of CD 6168|Accumulation ratio of CD 6168 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of CD 6168 versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2665871|NCT01528735|Secondary|Predose Measured Concentration of BI 208333|Predose measured concentration of BI 208333 (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2665872|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of BI 208333|"Mean residence time of BI 208333 (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).~This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||||||
2665873|NCT01528735|Secondary|AUC Accumulation Ratio of BI 208333|Accumulation ratio of BI 208333 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of BI 208333 versus AUC,ss of Deleobuvir (RA,AUC,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2665874|NCT01528735|Secondary|Cmax Accumulation Ratio of BI 208333|Accumulation ratio of BI 208333 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of BI 208333 versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2665875|NCT01528735|Secondary|Predose Measured Concentration of Faldaprevir|Predose measured concentration of Faldaprevir (BI 201335 ZW) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2665876|NCT01528735|Secondary|Apparent Clearance (CL/F,ss) of Faldaprevir|Apparent clearance of Faldaprevir (BI 201335 ZW) in plasma following extravascular administration on the 57th day (CL/F,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2665930|NCT01528332|Secondary|Change From Treatment in RMDQ at Follow up||Treatment (days +1 to +14) to Follow up (up to day +42)|||||||
2665931|NCT01528332|Secondary|Change From Baseline in RMDQ at Follow up||Baseline (days -7 to +1) to Follow-up (up to day +42)|||||||
2665877|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of Faldaprevir|"Mean residence time of Faldaprevir (BI 201335 ZW) in the body after oral administration at steady state (MRTpo,ss).~This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups."|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.||||||
2665878|NCT01528735|Secondary|AUC Accumulation Ratio of Faldaprevir|Accumulation ratio of Faldaprevir (BI 201335 ZW) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2665879|NCT01528735|Secondary|Cmax Accumulation Ratio (RA,Cmax,N) of Faldaprevir|Accumulation ratio of Faldaprevir (BI 201335 ZW) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2665880|NCT01528735|Secondary|Predose Measured Concentration of Deleobuvir|Predose measured concentration of BI 207127 (Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2665881|NCT01528735|Secondary|Apparent Clearance (CL/F,ss) of Deleobuvir|Apparent clearance of BI 207127 (Deleobuvir) in plasma following extravascular administration on the 57th day (CL/F,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.|||Litres per hour||Geometric Coefficient of Variation|Geometric Mean
2665882|NCT01528735|Secondary|Mean Residence Time (MRTpo,ss) of Deleobuvir|Mean residence time of BI 207127 (Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. Analysis includes patients with available data for this parameter.|||hours||Geometric Coefficient of Variation|Geometric Mean
2665883|NCT01528735|Secondary|AUC Accumulation Ratio of Deleobuvir|Accumulation ratio of BI 207127 (Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of Deleobuvir versus itself (RA,AUC,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2665884|NCT01528735|Secondary|Cmax Accumulation Ratio (RA,Cmax,N) of Deleobuvir|Accumulation ratio of BI 207127 (Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of Deleobuvir versus itself (RA,Cmax,Met,ss).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||Ratio||Geometric Coefficient of Variation|Geometric Mean
2665885|NCT01528735|Secondary|Area Under the Curve (AUC) of RBV|Area under the concentration time curve (AUC) of ribavirin (RBV) in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2665886|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of RBV|Time from last dosing to the maximum concentration of ribavirin (RBV) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
2665887|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of RBV|Maximum measured concentration of ribavirin (RBV) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2665888|NCT01528735|Secondary|Area Under the Curve (AUC) of CD 6168-AG|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ. AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2665889|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168-AG|Time from last dosing to the maximum concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
2665890|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of CD 6168-AG|Maximum measured concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N). AG=acylglucuronide.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2665891|NCT01528735|Secondary|Area Under the Curve (AUC) of CD 6168|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2665892|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168|Time from last dosing to the maximum concentration of CD 6168 (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
2665893|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of CD 6168|Maximum measured concentration of CD 6168 (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2665894|NCT01528735|Secondary|Area Under the Curve (AUC) of BI 208333|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2665895|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of BI 208333|Time from last dosing to the maximum concentration of BI 208333 (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
2665896|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of BI 208333|Maximum measured concentration of BI 208333 (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2665897|NCT01528735|Secondary|Area Under the Curve (AUC) of Faldaprevir|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2665898|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of Faldaprevir|Time from last dosing to the maximum concentration of Faldaprevir (BI 201335 ZW) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
2665932|NCT01528332|Secondary|Change From Treatment in VAS Pain Intensity at Follow up||Treatment (day +1 to +14) to Follow-up (up to day +42)|||||||
2665933|NCT01528332|Secondary|Change From Baseline in VAS Pain Intensity at Follow up||Baseline (day -7 to 1) to Follow-up (up to day +42)|||||||
2665900|NCT01528735|Secondary|Area Under the Curve (AUC) of Deleobuvir|Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2665901|NCT01528735|Secondary|Time From Last Dosing to the Maximum Concentration (Tmax) of Deleobuvir|Time from last dosing to the maximum concentration of Deleobuvir (BI 207127) in plasma after the morning dose of Nth day (Tmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|PK analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||hours||Full Range|Median
2665902|NCT01528735|Secondary|Maximum Measured Concentration (Cmax) of Deleobuvir|Maximum measured concentration of BI 207127 (Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).|10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57|Pharmacokinetic (PK) analysis set which included all evaluable patients. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2665903|NCT01528735|Secondary|Percentage of Participants With Virological Response at Week 8|Percentage of participants with plasma HCV RNA (hepatitis C virus ribonucleic acid ) level <25 IU/mL (undetected or detected) at week 8.|8 weeks|Full analysis set which included all patients with at least 1 on-treatment value of HCV RNA viral load|||percentage of participants|||Number
2665904|NCT01528735|Secondary|Percentage of Participants With Virological Response at Week 4|Percentage of participants with plasma HCV RNA (hepatitis C virus (HCV) ribonucleic acid (RNA)) level <25 IU/mL (undetected or detected) at week 4.|4 weeks|Full analysis set which included all patients with at least 1 on-treatment value of HCV RNA viral load|||percentage of participants|||Number
2665905|NCT01528735|Primary|Number of Patients With Drug-related Adverse Events|Number of patients with investigator defined drug-related Adverse Events|From first dose of study medication until 30 days after last dose of study medication, up to 199 days|Treated Set which included all patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
2665906|NCT01528709|Secondary|Vein Graft Stenosis 1 Year After CABG Based on CT Coronary Angiography|Vein graft stenosis 1 year after CABG based on CT coronary angiography|Within 1 year after CABG||||Vein grafts|Vein grafts||Count of Units
2665907|NCT01528709|Primary|Saphenous Vein Graft Occlusion (Percentage of Vein Grafts Occluded) Based on CT Coronary Angiography at 1 Year|Vein graft patency will be assessed in a blinded fashion by CT coronary angiography 1 year after CABG|1 year after CABG||||Vein grafts|Vein grafts||Count of Units
2665908|NCT01528696|Secondary|Patient Report of Pain Severity and Control|Self Reported pain, on a scale from 1 to 10, where 1 is little pain and 10 is extreme pain|6 weeks|For logistical reasons, we were unable to gather outcome data either by the intended survey or by chart review. When it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. Therefore no outcome data could be analyzed.||||||
2665909|NCT01528696|Secondary|Febrile Morbidity|Febrile morbidity would be measured by number of participants who experienced fever as a sign of infection at 2 days, and overall within 6 weeks of delivery.|2 days, 6 weeks|For logistical reasons, we were unable to gather outcome data either by the intended survey or by chart review. When it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. Therefore no outcome data could be analyzed.||||||
2665910|NCT01528696|Primary|Number of Patients Who Experience One or More Wound Complications|A composite of cellulitis, wound dehiscence, seroma, hematoma, abscess, and fascial dehiscence from wound evaluation at any point within six weeks, as pulled from the medical record or based on patient report.|6 weeks|For logistical reasons, we were unable to gather outcome data either by the intended survey or by chart review. When it became clear that we would be unable to complete the study, recruitment was terminated and further attempts at data gathering were stopped. Therefore no outcome data could be analyzed.||||||
2665911|NCT01528605|Secondary|Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention||at baseline, 24, 48 weeks and 2 years||2015-12-31|12/2015||||
2665912|NCT01528605|Secondary|Changes From Baseline in Microperimetry (MP) During the Intervention|Microperimetry (MP) was measured by the MP1 Microperimeter|at baseline, 24, 48 weeks and 2 years during the intervention||2015-12-31|12/2015||||
2665913|NCT01528605|Secondary|Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks||at baseline and 48 weeks during the intervention||2015-12-31|12/2015||||
2665914|NCT01528605|Secondary|Changes of Flash Recovery Time (FRT) Measured by MDD-2 Macular Adaptometer|Flash recovery time (FRT) was measured by MDD-2 macular adaptometer at baseline, 24, 48 and 96 weeks|at baseline, 24, 48 weeks and 2 years during the intervention||2015-12-31|12/2015||||
2665915|NCT01528605|Secondary|Changes of Contrast Sensitivity (CSF) Measured by CSV-100 During the Intervention||at baseline, 24, 48 weeks and 2 years during the intervention||2015-12-31|12/2015||||
2665916|NCT01528605|Secondary|Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention|best-spectacle corrected visual acuity (BSCVA) measured by ETDRS chart at baseline and 24 weeks, 48 weeks, 2 years during the intervention. Four participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.|at baseline and 24 weeks, 48 weeks, 2 years during the intervention||||letters||Standard Deviation|Mean
2665917|NCT01528605|Secondary|Changes of Serum Xanthophylls Concentrations During the Intervention|Changes of serum xanthophylls concentrations measured by high performance liquid chromatograph (HPLC)at baseline and 4, 12, 24 and 48 weeks during the first 48 weeks of intervention.Four participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.|at baseline and 4, 12, 24 and 48 weeks during the intervention||||μmol/L||Standard Deviation|Mean
2665918|NCT01528605|Primary|Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years|"Macular pigment is found in the center of the retina known as the macula and is made up of the carotenoids lutein and zeaxanthin. This pigment serves to protect the macula from harmful blue light. The MPOD ranges from 0 to 1, with higher scores corresponding with greater density (protection). The autofluorescence picture of subject's macular was analyzed for MPOD values.~4 participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer."|at baseline and 24 weeks, 48 weeks, 2 years during the intervention||||density units||Standard Deviation|Mean
2665919|NCT01528592|Primary|Correlation Coefficient Between UPDRS III Score and Independent Components Analysis Network Strength in Left Parietal Cortex.|Correlation coefficient between UPDRS III score and independent components analysis network strength in left parietal cortex. UPDRS III is the Unified Parkinson's Disease Rating Scale composite motor score.|1 hour||||unitless|||Number
2665920|NCT01528345|Secondary|Time to Worsening of ECOG Performance Status|Eastern Cooperative Oncology Group (ECOG) Performance Status (scales and criteria used by doctors and researchers to assess how a patient's disease is progressing and assess how the disease affects the daily living abilities of the patient.)|Screening, Every 4 weeks during treatment period, and every 8 weeks during follow-up (approximately 9-12 months)|This outcome measure was not analyzed as the study was terminated before time to worsening ECOG performance could be analyzed.||||||
2665921|NCT01528345|Secondary|Number of Participants With Adverse Events as a Measure of Safety|"The type, frequency and severity of adverse events, laboratory values, and Electrocardiograms (ECGs) experienced by patients will be assessed according to Common Terminology Criteria for Adverse Events.~The study enrollment was terminated early due to challenges in enrolling patients with FGF amplified status. See safety section for safety details."|Screening, Week 2, Week 4 and approximately every 4 weeks during treatment period (approximately 34 months)|Safety Set: Consisted of all patients who received at least one dose of any compound of the study treatment (dovitinib +fulvestrant or placebo+fulvestrant). Patients were analyzed according to the actual study treatment received. Actual treatment received was defined as the treatment the patient received at the first day of study medication.|||Participants|||Number
2665922|NCT01528345|Secondary|Overall Survival (OS) Using Kaplan- Meier Method|OS was defined as the time from the date of randomization to the date of death from any cause. If a patient is not known to have died at the date of analysis cut-off, the OS will be censored at the last date of contact.|From date of randomization to date of death from any cause whichever comes first, assessed up to 34 months|Full Analysis Set (FAS): Consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum to which they were assigned at randomization.|||Months||95% Confidence Interval|Median
2665923|NCT01528345|Secondary|Duration of Response (DOR)|DOR was defined as time from the date of the first documented response (CR or PR) to the date of the first documented or death due to disease. If a patient does not have a progression event, DOR will be censored on the date of the last adequate tumor assessment.|From date of first documented efficacy response (CR or PR) to time of documented progression (PD) whichever comes first, assessed up to 24 months|This outcome measure was not analyzed as the study was terminated before duration of response could be analyzed.||||||
2665924|NCT01528345|Secondary|Overall Response Rate (ORR)|ORR was defined as the percentage of patients with a best overall response of Complete Response (CR) or Partial Response (PR) as per RECIST v1.1. Responses include: Complete Response: Disappearance of all non-nodal target lesions; Partial Response: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; Progressive Disease: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline; Stable Disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.|Every 8 weeks assessed up to 34 months|Full Analysis Set (FAS): Consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum to which they were assigned at randomization.|||Percentage of participants||95% Confidence Interval|Number
2665925|NCT01528345|Primary|Progression Free Survival (PFS) Based on Local Investigator Assessment|PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause and was assessed based on RECIST v1.1. Responses include: Complete Response: Disappearance of all non-nodal target lesions; Partial Response: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; Progressive Disease: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline; Stable Disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; Unknown (UNK) Progression has not been documented and one or more target lesions have not been assessed or have been assessed using a different method than baseline.|Every 8 weeks assessed up to 34 months|Full Analysis Set (FAS): Consisted of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment and stratum to which they wereassigned at randomization.|||Months||95% Confidence Interval|Median
2665926|NCT01528332|Secondary|Average Visual Analog Scale Pain Relief Over 5 Treatments|The average pain relief scored on a 10.0 cm VAS pain relief scale (endpoints 0 = no pain, 10 = no relief|5 treatments (days +1 to +14)|||||||
2665927|NCT01528332|Secondary|Changes From Baseline in Skin Condition|Skin condition (erythema and hyperpigmentation as measured with the MX-18) and appearance (recorded with Polaroid photos) will be assessed once each at baseline and follow up, and before and after each treatment. The changes from baseline will be analysed using descriptive statistics and the two treatment arms compared.|Baseline (days -7 to -1) to Follow up (up to day +42)|||||||
2665928|NCT01528332|Secondary|Vital Sign Parameters|Vital signs (blood pressure and pulse)will be assessed at each visit and changes from baseline compared between the treatment groups|Baseline (days -7 to -1) to Follow up (up to day +42)|||||||
2665929|NCT01528332|Secondary|Frequency, Severity, Nature and Duration of Adverse Events During the Whole Duration of the Study|Adverse events will be assessed using descriptive statistical methods and compared between treatment arms.|Baseline (days -7 to -1) to Follow up (up to day +42)|||||||
2665934|NCT01528332|Secondary|Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) at Visit 5|The RMDQ is a 24 list of yes/no questions about the effects of back pain on the participants daily activities. Each positive answer is a point; maximum total score = 24.|Baseline (days -7 to +1) to Treatment 5 (day +14)|||||||
2665935|NCT01528332|Primary|Change From Baseline (Mean of Three Measurements at Screening, Prior to Treatment Visit 1 and Treatment Visit 1 Pretreatment) in the Average Visual Analog Scale (VAS) Pain Intensity Over the 5 Treatment Days|Pain intensity scored on a 10.0 cm VAS with the endpoints 0 = no pain; 10 = worst pain imaginable|Baseline (Visit 1/day -7, at home and Visit 2/day +1), Treatment (Visits 2-6 post treatment/days +1 to +14)||||cm||Standard Error|Mean
2665936|NCT01528319|Secondary|Adverse Event Evaluation|To evaluate all undesirable events which occurred between the time of obtainment of consent and 24 weeks after surgery|Between the time of obtainment of consent and 24 weeks after surgery||||participants|||Number
2665937|NCT01528319|Secondary|Number of Participants With Abnormal Changes in One or More Laboratory Tests|To evaluate changes over time in each laboratory test item from before surgery to 12 and 24 weeks after surgery regarding the presence or absence of abnormal changes, causal relationship with this product and causes for development|12 weeks and 24 weeks after surgery||||participants|||Number
2665938|NCT01528319|Secondary|Clinical Function Evaluation|"To evaluate the JSS-SIS score and Rowe score at 24 weeks after surgery~JSS-SIS Score (subscales are summed, higher values represent a better outcome):~Pain (0 to 20)~Function (0 to 20)~Range of Motion (0 to 20)~Evaluation of X-ray findings (0 to 10)~Stability (0 to 30)~Rowe Score (subscales are summed, higher values represent a better outcome):~Stability (0 to 50)~Motion (0 to 20)~Function (0 to 30)"|24 weeks||||units on a scale||Standard Deviation|Mean
2665939|NCT01528319|Secondary|Procedure Success|"The rate of successful cases when procedure success was defined as The anchors can be inserted into the burr holes without breakage and the glenohumeral ligament labral complex can be sutured without tear of the sutures"|12 weeks||||participants|||Number
2665940|NCT01528319|Primary|Clinical Function Evaluation|"To evaluate the Japan Shoulder Society Shoulder Instability Score (JSS-SIS) and Rowe Score at 12 weeks after surgery~JSS-SIS Score (subscales are summed, higher values represent a better outcome):~Pain (0 to 20)~Function (0 to 20)~Range of Motion (0 to 20)~Evaluation of X-ray findings (0 to 10)~Stability (0 to 30)~Rowe Score (subscales are summed, higher values represent a better outcome):~Stability (0 to 50)~Motion (0 to 20)~Function (0 to 30)"|12 weeks||||units on a scale||Standard Deviation|Mean
2665941|NCT01528319|Primary|Surgery Success|"The rate of successful cases when surgery success is defined as Procedure success is confirmed, the anchors are confirmed to be in the burr holes by the MRI examination, the glenohumeral ligament labral complex is maintained at the anterior edge of the glenoid cavity at 12 weeks after surgery, and there is no need of retreatment"|12 weeks after surgery||||participants|||Number
2665942|NCT01528293|Secondary|Degree of Take|Degree of split thickness skin graft taken or bioengineered alternative tissue induced wound shrinkage after 6 weeks of ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.|6 Weeks|Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.||||||
2665943|NCT01528293|Secondary|SF-12 Quality of Life Survey|Quality of life between ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.|9 weeks|Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.||||||
2665944|NCT01528293|Secondary|Compare the Time to Wound Bed Preparation, Quality of Life, Degree of Split Thickness Skin Graft/Bio-engineered Alternative Tissue Take|-Compare the time to wound bed preparation between the ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.|9 weeks|Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.||||||
2665945|NCT01528293|Primary|Compare Wound Healing|Wound healing between the ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.|6 weeks|Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.||||||
2665946|NCT01528254|Secondary|Percentage of Participants With Adverse Events, Serious Adverse Events and Death|Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) in each treatment arm to demonstrate that LAF237 is safe for the treatment of naïve patients with type 2 diabetes mellitus through the monitoring of relevant clinical and laboratory safety parameters.|From first dose of study treatment until End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)|Safety Set (SAF). Percentages are based on the number of patients starting each period.|||Percentage of Participants|||Number
2665947|NCT01528254|Secondary|Rate of Change in Insulin Sensitivity From Baseline to End of Study|The rate of change of insulin sensitivity is assessed using the slope of OGIS over time (years) where Oral glucose insulin sensitivity (OGIS) was calculated as a function of glucose and insulin, using meal-test data from 0 to 120 minutes. Baseline OGIS is derived based on samples obtained on day 1, or samples obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurements are missing. Three analyses were included, using data from Week 13 to the end of Period 1, end of Period 2 and end of study, respectively.|Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)|Full Analysis Set (FAS) meal-test subset|||Rate (%)||Standard Error|Mean
2665948|NCT01528254|Secondary|Rate of Loss of Beta Cell Function From Baseline to End of Study|The rate of change of beta cell function was assessed using the slope of AUC of ISR/G over time (years) where AUC of ISR/G is defined as (Area under curve of Insulin secretion rate (derived using c-peptide))/(Area under curve of Glucose), using meal-test data from 0 to 120 minutes. Baseline AUC of ISR/G was derived based on samples obtained on day 1, or samples obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurements were missing. Three analyses were included, using data from Week 13 to the end of Period 1, end of Period 2 and end of study, respectively.|Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)|Full Analysis Set (FAS) meal-test subset|||Rate (%)||Standard Error|Mean
2665949|NCT01528254|Secondary|Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) Over Time During Period 2|"Rate of loss in glycemic control was estimated using the slope of FPG over time (years).~FPG (fasting plasma glucose) data from 26 weeks after the start of Period 2 to then end of Period 2 was included in the analysis. Only participants who started insulin therapy in Period 3 or discontinued during Period 2 due to being unable or unwilling to initiate insulin therapy in period 3 were included. Participants who completed the study in Period 1 or Period 2 were not be included in the analysis."|From 26 weeks after start of Period 2 to end of Period 2|Full Analysis Set (FAS)|||Rate (%)||Standard Error|Mean
2665950|NCT01528254|Secondary|Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) During Period 1|"Rate of loss in glycemic control was estimated using the slope of FPG over time (years).~FPG (fasting plasma glucose) data from Week 26 to the end of Period 1 was included in the analysis. Baseline FPG was the sample obtained on day 1, or the sample obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurement is missing. Participants who completed the study in Period 1 or Period 2 were not be included in the analysis."|Visit 5 (Week 26) to End of Period 1|Full Analysis Set (FAS)|||Rate (%)||Standard Error|Mean
2665951|NCT01528254|Secondary|Rate of Loss in Glycemic Control in HbA1c Over Time During Period 2|"The rate of loss in glycemic control was estimated using the slope of HbA1c over time (years).~HbA1c data collected from 26 weeks after the start of Period 2 to the end of Period 2 were included in the analysis, for participants who started insulin therapy in Period 3 or discontinued during Period 2 due to being unable or unwilling to initiate insulin therapy in period 3. Participants who completed the study in Period 1 or Period 2 were not be included in the analysis."|From 26 weeks after start of Period 2 to end of Period 2|Full Analysis Set (FAS)|||Rate (%)||Standard Error|Mean
2665952|NCT01528254|Secondary|Rate of Loss in Glycemic Control During Period 1|"The rate of loss in glycemic control was estimated using the slope of HbA1c over time (years).~HbA1c data collected from Week 26 up to and including the end of Period 1 visit was included in the analysis. Baseline HbA1c was the sample obtained on day 1, or the sample obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurement was missing. End of Period 1 was defined as the final post-baseline assessment obtained at any visit within Period 1 (scheduled or unscheduled), up to the last scheduled visit."|Visit 5 (Week 26) to End of Period 1|Full Analysis Set (FAS)|||Rate (%)||Standard Error|Mean
2665953|NCT01528254|Primary|Time to Initial Treatment Failure|"Treatment failure was defined as two consecutive scheduled visits with HbA1c >= 7.0% (starting from 13 weeks after randomization) and the time to treatment failure was the number of days from randomization to the second of the consecutive scheduled visits.~Participants who discontinued the study for any reason during Period 1 were censored at the date of discontinuation. Participants who remained under the threshold (or whose measurement above the threshold was not confirmed at next scheduled visit) were censored at the date of last study visit."|Visit 4 (Week 13) up to End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)|Full Analysis Set (FAS)|||Rate (%)||95% Confidence Interval|Number
2665954|NCT01528228|Primary|Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.|The patient participant will record pain levels during the immediate post-op 2-week time period every day. Day 0 is pain level before surgery. Pain perception measured on a scale from 0-10 with 0 representing no or lowest level pain and 10 representing the highest level of pain|Two weeks postoperatively.||||score on 0-10 pain level scale||95% Confidence Interval|Least Squares Mean
2665955|NCT01528215|Secondary|Marginal Bone Level Change After 5 Years in Use.|Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 5 years follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).|Evaluated from implant loading to the 5 years follow-up after implant loading.|"In the EV group, 40 subjects (52 implants) completed the 5-year follow-up visit.~In the TX group, 45 subjects (64 implants) completed the 5-year follow-up visit."|||Millimeter|Implants|Standard Deviation|Mean
2665956|NCT01528215|Primary|Marginal Bone Level Change After 1 Year in Use.|Marginal bone level will be determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 1 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline). Positive value = bone gain, Negative value = bone loss.|Evaluated at implant loading and at the 1 year follow-up after implant loading.|"In the EV group, 55 subjects (73 implants) completed the 1 year follow-up visit.~In the TX group, 60 subjects (84 implants) completed the 1 year follow-up visit. Three of the radiographs were not possible to evaluate, giving an overall number of 59 subjects (81 implants) as basis for the analysis of marginal bone level change."|||Millimeter|Implants|Standard Deviation|Mean
2665957|NCT01528150|Primary|Freedom From RA and RV Lead-related Complications|Safety of the Accent MRI™ system with the Tendril MRI™ lead will be evaluated in terms of freedom from Right Atrial (RA) and Right Ventricular (RV) lead-related complications for the acute (implant to 2 month visit) and chronic (2 month visit through the 12 month visit) timeframes.|up to 12 months post-implant|A total of 464 patients were implanted. 463 patients (99.78%) were implanted with Accent MRI™ systems with the Tendril MRI™ leads while the remaining 1 patient (0.22%) was implanted with a device that was not an Accent MRI™ system. This patient was excluded from all primary endpoint analyses.|||percentage of participants||97.5% Confidence Interval|Number
2665958|NCT01528124|Secondary|Number of Participants Developing Anti-LY3025876 Antibodies|Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY3025876.|Day 28 post-dose|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2665959|NCT01528124|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876||Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose|PK Population: all participants who received at least 1 dose of study drug and had evaluable Cmax PK data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2666253|NCT01525563|Secondary|Amount of Menstrual Bleeding From Baseline to End of Treatment|Assessment of average number of pads changed per day at baseline and at the end of treatment (EOT).|6 months|The amount of menstrual bleeding (based on no. of pads used per day) was analyzed for all subjects completing EOT and change was noted from baseline to EOT|||pads/day||Standard Deviation|Mean
2665960|NCT01528124|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876|Area under the concentration-versus-time curve from time zero to infinity [AUC(0-∞)] of LY3025876.|Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose|Pharmacokinetic (PK) Population: all participants who received at least 1 dose of study drug and had evaluable AUC(0-∞) PK data.|||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2665961|NCT01528124|Primary|Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events|Possible drug-relatedness of an adverse event (AE) was in the opinion of the investigator. A summary of all serious and all other non-serious AEs, regardless of any possible causality, is located in the Reported Adverse Event Module.|Baseline up to 28 days post-dose|All enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2665962|NCT01528072|Primary|Fusion Rates|"Fusion was defined by meeting three criteria:~rotation < 5° between motion segments on flexion-extension radiographs~translation < 3 mm between motion segments on flexion-extension radiographs~presence of bridging bone. Fusion assessment for each patient was categorized as one of the four defined outcomes: fused, not fused, partial fusion, or UA (unable to assess). Efficacy was confirmed by the achievement of fusion in the experimental group when compared to the rate established in a literature control."|24 months post surgery date|Sixty-six (66) out of the original 140 implanted subjects completed their 24 month follow up. Sixty-one (61) subjects completed 24month radiograph for analysis of the primary end point.|||Participants|||Count of Participants
2665963|NCT01527942|Secondary|Response Rate - of 3=Excellent at Hour 24 Using 4-point Global Satisfaction With Regards to Overall Pain Management Rating Scale 0=Poor to 3= Excellent.|The 4-point patient global satisfaction of pain management scale is self-reported and scores range from 0=poor to 3=excellent. Response rate of 3=excellent at 24 hours after baseline.|24 hours after baseline|Study was terminated - data were determined to be unusable by IRB due to consent issues.||||||
2665964|NCT01527942|Secondary|Change in Pain Intensity on the 10-point Pain Intensity Scale Between Baseline and 24 Hours|The 10-point Pain Intensity Scale is self-reported and scores range from 0=no pain to10=worst possible. Change = (24 hour score - baseline)|baseline and 24 hours|Study was terminated - data were determined to be unusable by IRB due to consent issues.||||||
2665965|NCT01527942|Primary|Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours|The 5-point Pain Relief Score is self-reported and scores range from 0=none, 1=little, 2=some, 3=a lot, 4=complete. Change = (24 hour score - baseline)|baseline and 24 hours|Study was terminated - data were determined to be unusable by IRB due to consent issues.||||||
2665966|NCT01527682|Secondary|Number of Eyes With an Adverse Event (AE)|The occurrence of the following events will be monitored: growth of the eyelashes (hypertrichosis), changes iris colour, corneal epitheliopathy, allergic conjunctivitis, increase of central corneal thickness, non-serious and serious adverse event occurrence.|3 years|Eyes affected by Primary congenital glaucoma not sufficiently responder to a single surgical procedure|||eyes|eyes||Number
2665967|NCT01527682|Secondary|Time to Treatment Failure (TTF)|calculated as the time from the date of baseline visit to the date in which the medical treatment will be stopped, since IOP control will be considered not satisfactory|3 years||||eyes|eyes|Inter-Quartile Range|Median
2665968|NCT01527682|Primary|Percentage of Eyes With Response|defined as those eyes in which the decrease of intraocular pressure (IOP) of at least 20% with respect to baseline assessment will be achieved and maintained during the 3-year period of study duration|3 years||||eyes|eyes||Count of Units
2665969|NCT01527513|Secondary|Change From Baseline in Seizure Frequency During the One-year Open-Label (OL)|Overall Change from Baseline in Seizure Frequency per week for the One-Year Open-Label Period|Weeks 1 to ≥ 41 weeks|Modified Efficacy Intent-to-Treat (ITT) population– all randomized patients who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.|||Seizure per week||Standard Error|Mean
2665970|NCT01527513|Secondary|Change From Baseline in Standardized Seizure Frequency - Part I||Baseline; Titration Period (4 Weeks: V2-V3-V4)|Modified Efficacy ITT population – all randomized patients who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.|||Seizures per week||Standard Deviation|Mean
2665971|NCT01527513|Primary|Change From Baseline in Power of Attention Score to the End of the Double Blind (DB) Period|Power of Attention was defined as the sum of the reaction time measures from the attentional tasks (simple [dominant hand only] reaction time, choice reaction time and digit vigilance speed) in order to assess information processing speed and attention/psychomotor speed.Change from baseline to the end of the double-blind period in Power of Attention will be compared between the treatment groups using an ANCOVA. Non-inferiority of ESL vs Placebo will be assessed by comparing the 95% CI's upper bound of the difference of Least Squares Mean (LSmeans) between treatment groups (ESL-placebo) with 121 ms. If the upper bound is greater than 121 ms then the null hypothesis that the change from baseline in the Power of Attention score in ESL group is at least 121 ms inferior than the placebo group will be rejected. Single Values were calculated the average of post treatment visits (visits 5 and 7or EDV) minus average of baseline visits (visits 1 and 2)|Visit 1 (-4 weeks for training), Visit 2 (Day 1), Visit 5 (6 weeks), Visit 7 (12 weeks) or at early discontinuation visit (EDV)|The primary analysis was based on the Cognitive Per-protocol (PP) population – all patients in the Modified Cognitive Intent-to-Treat (ITT) population who completed the 8-week maintenance period and were not Important Protocol Deviations (IPDs) with respect to the primary cognitive endpoint.|||Milli seconds (ms)||Standard Error|Mean
2665972|NCT01527500|Secondary|Part B: Cmax_D - Summary Statistic for PK Parameters|Cmax_D=ng/mL/mg|Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85)|Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data.|||ng/mL/mg||Standard Deviation|Mean
2665973|NCT01527500|Secondary|Part B: Cmax - Summary Statistic for PK Parameters|Summary statistic for Part B of total LFG316 concentrations (pharmacokinetic analysis set) Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose|Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85)|Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data.|||ng/mL||Standard Deviation|Mean
2665974|NCT01527500|Secondary|Tmax (hr)|"PART B: Tmax (Time of Maximum concentration observed)~This is the highest concentration of drug in the blood that is measured after a dose. Cmax usually happens within a few hours after the dose is taken. The time that Cmax happens is referred to as Tmax. For some antiretroviral drugs, a high Cmax is thought to increase the risk of side effects from the drug."|Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85)|Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data.|||hours||Full Range|Median
2665975|NCT01527500|Primary|Part B: Safety and Tolerability of a Single Intravitreal (IVT) Dose of 10 mg/100 μL of LFG316 in Patients With Advanced AMD).|This primary outcome (for Part B) is reported under the Adverse Events section.|Day 1 to Day 85||||number of patients|||Number
2665976|NCT01527500|Secondary|Part B: AUC (Area Under the Curve) - Summary Statistics for PK Parameters|"Summary statistic of total LFG316 concentrations (pharmacokinetic analysis set)~n=number of participants, h=scheduled sampling time"|Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85)|Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data.|||hr*ng/mL||Standard Deviation|Mean
2665977|NCT01527500|Primary|Part A: Sensitivity Analysis of the Primary End Point: Mixed Effects Model for Repeated Measurements on GA Lesion Growth Measured by Fundus Autoflourescence|Number is the Estimated Difference (95% CI) in lesion size.|The primary objective was from Day 1 to Day 337, however data was captured to Day 505 as exploratory objective|PD Set which included patients who had at least one dose of study drug and had evaluable PD Data.|||mm^2||95% Confidence Interval|Mean
2665978|NCT01527500|Secondary|Part A: Concentrations of Total C5 in Blood During the Course of the Study|Summary statistic of total C5 concentrations n=number of participants, h=scheduled sampling time|Day 1 to Day 559 (starting from the day of first intravitreal injection to day 559)|PD Analysis includes patients who received at least one dose of study drug with evaluable PD data.|||ng/mL||Standard Deviation|Mean
2665979|NCT01527500|Secondary|Part A: Concentrations of Total LFG316 in Blood During the Course of the Study|"Summary statistic of total LFG316 concentrations (pharmacokinetic analysis set)~n=number of participants, h=hours after the last administered dose e.g.; 0.0 means just before dosing. If the mean concentration is 0.00, that means there is no drug in the bloodstream"|Day 1 to Day 559 (starting from the day of first intravitreal injection to day 559)|Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data.|||ng/mL||Standard Deviation|Mean
2665980|NCT01527500|Secondary|Part A: Summary of Best Corrected Visual Acuity Over Time, Statistical Analysis of Change in Best Corrected Visual Acuity Over Time Parameter: Visual Acuity (EDTRS Letter) BCVA Scale is 0-100, Worst is 0 and Best 100 Eye: FELLOW|Part A: Summary of best corrected visual acuity over time, statistical analysis of change in best corrected visual acuity over time Parameter: Visual Acuity (EDTRS letter) BCVA scale is 0-100, worst is 0 and best 100 Eye: FELLOW|Baseline Day 1, Day 169, Day 337 to Day 505|PD analysis set which includes all patients with at least one dose of study drug and evaluable PD data.|||ETDRS Letters||Standard Deviation|Mean
2665981|NCT01527500|Secondary|Part A: Change in Best Corrected Visual Acuity (BCVA) as Measured by the EDTRS (Early Treatment of Diabetic Retinopathy Study) Scale From Baseline to Days 169, 337 & 505 in Patients Receiving Every 28 Days, Successive IVT Doses of LFG316 Compared to Sham|Part A: Summary of best corrected visual acuity over time, statistical analysis of change in best corrected visual acuity over time Parameter: Visual Acuity (EDTRS letter) BCVA scale is 0-100, worst is 0 and best 100 Eye: STUDY|Baseline Day 1, Day 169, Day 337 to Day 505|PD analysis set which includes all patients with at least one dose of study drug and evaluable PD data.|||ETDRS letters||Standard Deviation|Mean
2665982|NCT01527500|Secondary|Part A: Change From Baseline in GA Lesions Growth Measured by Fundus Autofluorescence|Mean change in GA lesion growth from baseline to Day 169 and Day 505.|Day 1 to Day 169 and Day 505 (starting from the day of first intravitreal injection until Day 505)|PD Set which included patients who had at least one dose of study drug and had evaluable PD Data.|||mm^2||Standard Deviation|Mean
2665983|NCT01527500|Primary|Part A: Geographic Atrophy (GA) Lesion Growth Measured by Fundus Autofluorescence (FAF) From Baseline to Day 505|Geographic atrophy (GA) lesion growth measured by fundus autofluorescence (FAF) from baseline to Day 505.|Day 1 to Day 505 (starting from the day of first intravitreal injection until Day 505)|Pharmacodynamic analysis set (PD) which includes all patients with at least one dose of study drug and evaluable PD data.|||mm^2||Standard Deviation|Mean
2665984|NCT01527487|Secondary|Disease-Free Survival (DFS) at 2 Years|Defined as the percent probability that participants had not experienced disease recurrence or died from any cause at 2 years post-surgery, analyzed by Kaplan-Meier methodology.|24 months|Includes all patients that completed surgery.|||percent probability of survival||95% Confidence Interval|Number
2665985|NCT01527487|Secondary|Clinical Response Rate (cRR) of ErC as Neoadjuvant Therapy|Defined as the number of patients with a best response of clinical complete or partial response (cCR or cPR) divided by the number of patients qualified for tumor response analysis per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1 for target lesions and assessed by MRI or CT. Complete Response (CR) defined as disappearance of all target lesions; Partial Response (PR) defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD;|43 months|All patients evaluated/evaluable per RECIST v1.1|||percentage of participants|||Number
2665986|NCT01527487|Secondary|The Number of Adverse Events as a Measure of Safety and Tolerability.|Treatment-Related Adverse Events occurring in >= 15% of treated patients|43 months||||participants|||Number
2665987|NCT01527487|Primary|Pathologic Complete Response (pCR) Rate in Patients Treated With ErC for 6 Cycles Prior to Surgery|One cycle = 21 days. Pathologic CR is defined as the absence of invasive tumor in the breast and lymph node tissue removed at the time of definitive surgery as judged by the local pathologist.|18 weeks|Patients who completed 6 cycles and proceeded to surgery.|||percentage of surgical patients|||Number
2665988|NCT01527383|Secondary|Percentage of Participants With Elevated Temperature Prompted on the Vaccination Report Card|Elevated temperature is defined as ≥100.4 °F (≥38.0 °C), oral equivalent. The percentage of participants with VRC-prompted elevated temperature was assessed.|Up to ~28 days after Vaccination 4 (~Day 118)|All participants who received at least one dose of vaccine and had safety follow-up|||Percentage of participants|||Number
2665989|NCT01527383|Secondary|Percentage of Participants With a Systemic Adverse Event Prompted on the Vaccination Report Card|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. VRC-prompted systemic AEs included non-injection-site varicella-like and HZ-like rashes. The percentage of participants with one or more VRC-prompted systemic AE was assessed.|Up to ~28 days after Vaccination 4 (~Day 118)|All participants who received at least one dose of vaccine and had safety follow-up|||Percentage of participants|||Number
2665990|NCT01527383|Secondary|Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Vaccination Report Card (VRC)-prompted injection-site AEs were erythema, pain, and swelling. The percentage of participants with one or more VRC-prompted injection-site AE was assessed.|Up to Day 5 after any vaccination|All participants who received at least one dose of vaccine and had safety follow-up|||Percentage of participants|||Number
2665991|NCT01527383|Primary|Percentage of Participants With a Serious Adverse Event|A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants with one or more SAE was assessed.|Up to ~28 days after Vaccination 4 (~Day 118)|All participants who received at least one dose of vaccine and had safety follow-up|||Percentage of participants|||Number
2665992|NCT01527383|Primary|GMFR in VZV Antibody Response Measured by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay|Serum samples were tested for activity using a VZV ELISPOT assay. The assay detects IFN-γ-secreting, VZV-specific cells from peripheral blood mononuclear cells (PBMCs). The unit of measure of the assay is ELISPOT cell count / 10^6 PBMCs, and is expressed as geometric mean count (GMC). The GMFR is GMC at ~28 days after Vaccination 4 / GMC predose on Day 1.|Baseline and ~28 days after Vaccination 4 (~Day 118)|Participants with Day 1 and/or postdose data available. This outcome measure applied only to participants who received V212; placebo participants were not assessed for this outcome.|||Ratio||95% Confidence Interval|Geometric Mean
2665993|NCT01527383|Primary|Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA)|Serum samples were tested for antibody response using a gpELISA. The GMFR is response at approximately 28 days postdose 4 / response predose on Day 1.|Baseline and ~28 days after Vaccination 4 (~Day 118)|Participants with Day 1 and/or postdose data available. This outcome measure applied only to participants who received V212; placebo participants were not assessed for this outcome.|||Ratio||95% Confidence Interval|Geometric Mean
2665994|NCT01527370|Primary|Number of Participants With Serious Adverse Events|"A serious adverse event is one that results in death, is life-threatening, results in a persistent or significant disability, results in or prolongs hospitalization, results in a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgment."|Up to 42 days postvaccination|This endpoint was analyzed in all participants who were vaccinated and had any safety follow up data.|||Participants|||Number
2665995|NCT01527370|Primary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination|GMFR was analyzed as the geometric mean of the ratio of VZV antibody titer (gpELISA units/mL) at postvaccination week 6 over VZV antibody titer (gpELISA units/mL) at prevaccination day 1.|Prevaccination up to 6 weeks postvaccination|This endpoint was analyzed in the per-protocol population which included all participants who were vaccinated and had no major deviations from the protocol procedure. At the week 6 postvaccination timepoint, a total of 7 participants were excluded from the per-protocol immunogenicity analyses.|||Ratio||95% Confidence Interval|Geometric Mean
2665996|NCT01527370|Primary|The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination|Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA).|Prevaccination up to 6 weeks postvaccination|This endpoint was analyzed in the per-protocol population which included all participants who were vaccinated and had no major deviations from the protocol procedure. At the week 6 postvaccination timepoint, a total of 7 participants were excluded from the per-protocol immunogenicity analyses.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2665997|NCT01527357|Secondary|Number of Participants Who Required Red Blood Cells|"Red blood cells are defined as including World Health Organization (WHO) DRUG terms of Blood cells, packed human, Blood, whole, Red blood cells, Red blood cells, concentrated and Red blood cells, leucocyte depleted."|Within 29 days|Efficacy population|||Participants|||Count of Participants
2665998|NCT01527357|Secondary|Number of Participants Who Require Alternative Hemostatic Agents at 5 Minutes|If hemostasis is not achieved within 5 minutes, the treatment is considered to have failed, and the surgeon is to implement additional hemostatic measures.|At 5 minutes|Efficacy population|||Participants|||Count of Participants
2665999|NCT01527357|Secondary|Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)|An adverse event (AE) is any untoward medical occurrence (including clinically significant changes in laboratory values or other clinical tests) experienced by a participant administered a pharmaceutical product regardless of causal relationship with the treatment. A TEAE is any adverse event reported on the case report form that occurs after start of treatment or any adverse event with a missing start date.|Within 29 days|Safety population, defined as all participants who were randomized and received study treatment.|||Participants|||Count of Participants
2666000|NCT01527357|Secondary|Restricted Mean TTH|Restricted mean TTH over 5 minutes is computed using Irwin's estimator, based on data collected by surgery type and treatment.|Within 5 minutes|Efficacy population. Number analyzed is the number of participants with data available for analysis in each surgery type.|||minutes||Standard Error|Mean
2668319|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Mean Error)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)|study day 1|Final population for data analysis|||kilograms||Standard Deviation|Mean
2666001|NCT01527357|Primary|Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection|The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.|Within 5 minutes|Efficacy population|||minutes||95% Confidence Interval|Median
2666002|NCT01527357|Primary|Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection|The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.|Within 5 minutes|Efficacy population|||minutes||95% Confidence Interval|Median
2666003|NCT01527357|Primary|Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery|The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.|Within 5 minutes|Efficacy population|||minutes||95% Confidence Interval|Median
2666004|NCT01527357|Primary|Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery|The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.|Within 5 minutes|Efficacy population consists of all participants who were randomized, received study treatment, and had a TTH assessment. Number analyzed is the number of participants in the efficacy population who receive each type of surgery.|||minutes||Inter-Quartile Range|Median
2666005|NCT01527292|Secondary|Vertebra Measurement|To measure the dimensions of the treated vertebra(e) at 1 year|For 1 year post treatment|Data not analyzed due to low enrollment and early termination of study||||||
2666006|NCT01527292|Secondary|Toxicity Rate Estimation|To estimate the toxicities of the treatment|For 1 year post treatment|Data not analyzed due to low enrollment and early termination of study||||||
2666007|NCT01527292|Secondary|Feasibility Rate Estimation|To estimate the feasibility rate of the study procedure (the percentage of patients in overall and each arm that complete the treatment).|For 1 year post treatment|Data not analyzed due to low enrollment and early termination of study||||||
2666008|NCT01527292|Secondary|Quality of Life Estimate|To estimate the quality of life using the Oswestry Disability Questionnaire|For 1 year post treatment|Data not analyzed due to low enrollment and early termination of study||||||
2666009|NCT01527292|Secondary|Reduction of Pain Estimate|To estimate the relative quantitative reduction of pain from baseline in patients in each arm.|For 1 year post treatment|Data not analyzed due to low enrollment and early termination of study||||||
2666010|NCT01527292|Primary|Numerical Rating Pain Scale (NRPS) Change in Patients|To determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s)at 1 month, 2-4 months and 5-6 months post-treatment and to validate of the movement-related pain score|For 6 months post treatment|Data not analyzed due to low enrollment and early termination of study||||||
2666011|NCT01527162|Secondary|Assessment of Life Habits for Children (LIFE-H)|Participation in habits of daily life will be by parental report of the Life Habits questionnaire(Life-H for children) by the weighted total score on a scale of 0 to 9, with a higher score representing more participation in habits of daily life.|previous 7 day reference||||units on a scale||Standard Deviation|Mean
2666012|NCT01527162|Secondary|Physical Activity Scale for Kids - Performance Version (ASKp)|Physical activity will be by parental report of Physical Activities Scale for Kids performance version (ASKp) survey- total score. Scale ranges from 0 to 100 with higher scores representing more physical activity. A score of 100 on this criterion referenced evalutive measure is consistent with physical activity like that of a typically developing 5 year old.|previous 7 day reference||||units on a scale||Standard Deviation|Mean
2666013|NCT01527162|Primary|Walking Activity Levels|Daily walking activity will be measured with the StepWatch accelerometer documenting average strides/day.|average of 5 days of second week of intervention||||average total strides/day||Standard Deviation|Mean
2666014|NCT01527110|Secondary|Mean Change From Baseline in Quantitative Viral Load Measured by Viral Culture From Nasopharyngeal Swabs Over Period|Quantitative viral culture as 50 % tissue culture infectious dose (TCID50) defined as median tissue culture infective dose is that amount of a pathogenic agent that produces pathological change in 50% of cell cultures inoculated. It was carried out on nasopharyngeal swabs collected on Day 1 up to Day 33 (last day) depending on the extend of continuation of treatment and duration of hospitalization. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value. Any undetectable viral load values were calculated as x.x Log10 TCID50: x.x Log10 (1.5 or 7.5 was the lower or upper limit of quantification in TCID50). Data is presented for Day 3, Day 5 and last day.|Baseline (Day 1) up to Day 33 (follow-up)|ITT-E Population. Only those participants available at the specified time points were analyzed.|||LOG TCID50/mL||Standard Deviation|Mean
2666015|NCT01527110|Secondary|Mean Change From Baseline in Quantitative Viral Load Measured by RT-PCR From Nasopharyngeal Swabs Positive at Baseline Over Period|Quantitative RT-PCR was carried out on nasopharyngeal swabs collected on Day 1 up to Day 33 (last day) depending on the extend of continuation of treatment and duration of hospitalization. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value. Analysis was done for participants with positive Influenza A RNA and Influenza B RNA. Data is presented for Day 3, Day 5 and last day.|Baseline (Day 1) up to Day 33 (follow-up)|ITT-E Population. Only those participants available at the specified time points were analyzed.|||Logarithmic base 10 (log 10) copies/mL||Standard Deviation|Mean
2666016|NCT01527110|Secondary|Median Time to no Detectable Viral RNA by Quantitative RT-PCR and Viral Culture From Nasopharyngeal Samples Over Period|Quantitative RT-PCR and quantitative viral culture was carried out on nasopharyngeal swabs collected on Baseline (Day 1) up to Day 33 (follow-up) depending on the extend of continuation of treatment and duration of hospitalization.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population. Only those participants available at the specified time points were analyzed.|||Days||Full Range|Median
2669417|NCT01495858|Secondary|Cumulative Proportion of Participants Taking Rescue Medication by Hour|If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded|Up to 10 hours|Safety Population|||participants|||Number
2666017|NCT01527110|Secondary|Percentage of Participants With Undetectable Viral RNA and Absence of Cultivable Virus in Lower Respiratory Samples Over Period|Quantitative RT-PCR and quantitative viral culture was carried out on lower respiratory samples (endotracheal aspirates) collected on Baseline (Day 1) up to Day 33 (follow-up) depending on the extend of continuation of treatment and duration of hospitalization. Endotracheal aspirates were used in participants who were intubated. Undetectable RNA concentrations were below the level of quantification.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population.|||% of participants|||Number
2666018|NCT01527110|Secondary|Percentage of Participants With Undetectable Viral RNA and Absence Cultivable Virus From Samples Obtained From Nasopharyngeal Samples Over Period|Quantitative RT-PCR and quantitative viral culture was carried out on nasopharyngeal swabs collected from Baseline (Day 1) up to Day 33 (follow-up) depending on the extend of continuation of treatment and duration of hospitalization of the participants. Undetectable RNA concentrations were below the level of quantification.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population.|||% of participants|||Number
2666019|NCT01527110|Secondary|Median Time to Virologic Improvement Over Period|Virologic improvement was defined as a 2 log drop in viral load or sustained undetectable viral ribonucleic acid (RNA), on 2 successive occasions as measured by quantitative reverse transcriptase - polymerase chain reaction (RT-PCR) from nasopharyngeal samples. Assessment was done from Baseline (Day 1) up to Day 33 (follow-up).|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population. The number of participants available at that particular time point were used for analysis.|||Days||Full Range|Median
2666020|NCT01527110|Secondary|Number of Participants With Complications of Influenza and Associated Use of Antibiotics Over Period|"The details of complications of influenza like bacterial pneumonia, pneumothorax, pleural effusion, acute respiratory distress syndrome (ARDS), myositis, encephalitis, myocarditis and associated antibiotic use were assessed from Baseline (Day 1) to Day 33 (follow-up). Participants with complications of influenza, with associated use of antibiotics as  associated antibiotic use yes and without associated use of antibiotics as associated antibiotic use no were categorized."|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population.|||Participants|||Count of Participants
2666021|NCT01527110|Secondary|Median Duration of Clinical Symptoms of Influenza Over Period|Influenza symptoms were assessed at Baseline (pre-dose) and throughout the study period as presence of the following symptoms were recorded: nasal symptoms (rhinorrhea, congestion), feverishness, cough, myalgias, fatigue, diarrhea, anorexia, dyspnea, headache, sore throat, nausea and vomiting. The investigator assessed and recorded influenza symptoms based on interview with the participants. In cases where participants were not able to communicate their symptoms, in participants ventilated and/or sedated, the investigator recorded those signs/symptoms as 'unable to assess'.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population. Only those participants available at the specified time points were analyzed.|||Days||Full Range|Median
2666022|NCT01527110|Secondary|Number of Participants of Clinical Symptoms of Influenza Over Period|Influenza symptoms were assessed at Baseline (pre-dose): the presence of the following symptoms were recorded: nasal symptoms (rhinorrhea, congestion), feverishness, cough, myalgias, fatigue, diarrhea, anorexia, dyspnea, headache, sore throat, nausea and vomiting. The investigator assessed and recorded influenza symptoms based on interview with the participants. In cases where participants were not able to communicate their symptoms, in participants ventilated and/or sedated, the investigator recorded those signs/symptoms as 'unable to assess'.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population.|||Participants|||Count of Participants
2666023|NCT01527110|Secondary|Number of Participants With or Without Treatment Emergent Resistance or Suspected Treatment Emergent Resistance to Zanamivir Over Period|A total of 30 neuraminidase gene sequences (23 influenza A/H3N2, 5 influenza B and 2 negative) from 21 participants were obtained from 76 samples. There were no resistance associated neuraminidase mutations or mutations in the neuraminidase active site identified in viruses isolated during this study. Therefore the frequency of resistance emergence to zanamivir could not be determined.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population. The number of participants with Influenza A/H3N2 (17) and Influenzavirus B (3) were used for analysis.|||Participants|||Count of Participants
2666024|NCT01527110|Secondary|Mean 50% Inhibitory Concentration (IC50) for Phenotypes of Influenza for the Measure of Viral Susceptibility to Zanamivir at All Visits|IC50 value is defined as the concentration of zanamivir required to achieve half maximal inhibition of the influenza viral enzyme neuraminidase of influenza A and B to prevent the release and spread of influenza virus in the respiratory tract. Susceptibility analyses were performed on nasopharyngeal swabs collected on Baseline (Day 1) up to Day 33 (follow-up) depending on the extend of continuation of treatment and duration of hospitalization. Endotracheal aspirates were used in participants who were intubated. Data is categorized for participants with influenza A/H3N2 and influenza B.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population. The number of participants available at that particular time point were used for analysis.|||Nanomole per liter (nmol/L)||Standard Deviation|Mean
2666025|NCT01527110|Secondary|Median Duration of Hospital Stay for the Participants Over Period|The duration of hospital stay was assessed from the first day of dosing (Day 1) up to Day 33 (follow-up). The duration was calculated as duration in hospital = date/time of discharge - date/time of 1st day of dosing.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population. The number of participants available at that particular time point were used for analysis.|||hour||Full Range|Median
2666026|NCT01527110|Secondary|Median Duration of Intensive Care Unit (ICU) Stay for the Participants Over Period|The duration of ICU stay was assessed from the first day of dosing (Day 1) up to Day 33 (follow-up). Duration in ICU was captured from the eCRF. If the duration in ICU was missing, then the data was set to 0.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population.|||Days||Full Range|Median
2666027|NCT01527110|Secondary|Median Duration of Use of Invasive and Non-invasive Ventilatory Support and Oxygen Supplementation Over Period|The non-invasive ventilator support includes modalities of machine-assisted: CPAP and BiPAP. The invasive ventilator support included modalities of machine-assisted: ECMO and endotracheal mechanical ventilation. Participants with use of modality of invasive, non-invasive ventilatory support and oxygen supplementation was assessed from Baseline (Day 1) to Day 33 (follow-up).|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population. The number of participants with use of modality of invasive and non-invasive ventilatory support (3) and oxygen supplementation (11) were analysed.|||hour||Full Range|Median
2666028|NCT01527110|Secondary|Number of Participants With and Without Use of Modality of Invasive, Non-invasive Ventilatory Support and Oxygen Supplementation Over Period|The non-invasive ventilator support includes modalities of machine-assisted: continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP). The invasive ventilator support included modalities of machine-assisted: extra corporeal membrane oxygenation (ECMO) and endotracheal mechanical ventilation. Participants with and without use of modality of invasive, non-invasive ventilatory support and oxygen supplementation was assessed from Baseline (Day 1) to Day 33 (follow-up).|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population.|||Participants|||Count of Participants
2666029|NCT01527110|Secondary|Median Time to Return to Pre-morbid Level of Activity Over Period|Pre-morbid functional status was defined as the best functional status in the 4 weeks prior to enrolment and status at Baseline (Day 1). The participants were assessed on a 3-point scale by activity level (bed rest, limited ambulation or unrestricted) recorded in thee electronic case report form (eCRF). For participants who were unable to communicate their pre-morbid functional status, the information was requested from another close member of the household or close family member.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population. The number of participants available at that particular time point were used for analysis.|||hour||Full Range|Median
2666030|NCT01527110|Secondary|Median Time to Clinical Response Over Period|Clinical response was defined as resolution of at least 4 of the 5 vital signs within the respective resolution criteria of temperature <= 36.6 degree C-axilla or <= 37.2 degree C-oral or <= 37.7 degree C-rectal/ tympanic, without the use of antipyretics within 8 hour; OS of >= 95%; respiratory status of return to pre-morbid oxygen requirement (participants with chronic oxygen use) or need for supplemental oxygen (administered by any modality) to no need for supplemental oxygen or RR <= 24 breaths/min without supplemental oxygen; HR <=100 beats/min; SBP of >= 90 mmHg without inotropic support within 8 h, maintained for at least 24 hour, or hospital discharge, which ever occurred first. Participants discharged from hospital due to clinical improvement/resolution were considered to have met the clinical response endpoint at the time of hospital discharge and were not required to have documented resolution of at least 4 response criteria i.e. achieved success at the time of discharge.|Baseline (Day 1) to Day 33 (follow-up)|ITT-E Population. The number of participants available at that particular time point were used for analysis.|||hour||Full Range|Median
2666031|NCT01527110|Secondary|Median Time to Absence of Fever, Improved Respiratory Status, Improved OS, Improved HR and Improved SBP Over Period|Absence of fever, improved respiratory status, OS, HR and SBP was defined according to clinical response criteria as: temperature, <= 36.6 degree C-axilla or <= 37.2 degree C-oral or <= 37.7 degree C-rectal and tympanic, without the use of antipyretics within 8 hour; OS of >= 95%; respiratory status of return to pre-morbid oxygen requirement (participants with chronic oxygen use) or need for supplemental oxygen (administered by any modality) to no need for supplemental oxygen or RR <=24 breaths/min without supplemental oxygen; HR <=100 beats/min; SBP of >=90 mmHg without inotropic support within 8 hour. For OS, participants with a history of chronic hypoxia (without supplemental oxygen) satisfied normalization criteria for OS if the value without supplemental oxygen was <=2% from participants historical OS and waiver for participants with a history of chronic supplemental oxygen requirement with baseline OS <95% with supplemental oxygen, recorded within 12 months prior to enrolment.|Baseline (Day 1) to Day 33 (follow-up)|Intent-to-Treat Exposed (ITT-E) Population comprised of all participants who receive at least one dose of IV zanamivir. Only those participants available at the specified time points were analyzed.|||hour||Full Range|Median
2666032|NCT01527110|Primary|Percentage of Participants With Abnormal Clinically Significant ECG Findings Over Period|12-lead ECG assessments were obtained at Baseline (Day 1) and Day 4 of the treatment period. On Baseline (Day 1), 2 baseline ECGs were obtained. On Day 4, 2 ECGs were obtained, 1 ECG just prior to study drug infusion and 1 ECG at the end of infusion. Overall ECG findings were summarized at Day 1 (ECG 1 and ECG 2) and Day 4 (pre-dose and 30-min post dose).|Baseline ( pre-dose Day 1) and Day 4|Safety Population. Only those participants available at the specified time points were analyzed.|||% of participants|||Number
2666033|NCT01527110|Primary|Number of Participants With Abnormal Clinically Significant Electrocardiograph (ECG) Findings Over Period|12-lead ECG assessments were obtained at Baseline (Day 1) and Day 4 of the treatment period. On Baseline (Day 1), 2 baseline ECGs were obtained prior to study drug infusion. On Day 4, 2 ECGs were obtained, 1 ECG just prior to study drug infusion and 1 ECG at the end of infusion. Overall ECG findings were summarized with regard to visits at Day 1 (pre-dose [ECG 1 and ECG 2]) and Day 4 (pre-dose and 30-min post dose).|Baseline (Day 1, pre-dose) and Day 4|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2666034|NCT01527110|Primary|Mean Temperature of Participants Over Period|Vital signs of temperature was assessed three times daily during the treatment period/hospitalization at Day 1, Day 2, Day 3, Day 4, Day 5 and Day 6. The baseline assessments were referred to assessments at Day 1. Maximum value in a day is reported, where a'day' was defined as a 24 h period (Treatment Day).|Baseline (Day 1) to Day 6|Safety Population. Only those participants available at the specified time points were analyzed.|||Degrees celcius (C)||Standard Deviation|Mean
2666035|NCT01527110|Primary|Mean Respiratory Rate (RR) of Participants Over Period|Vital signs of RR was assessed three times daily during the treatment period/hospitalization at Day 1, Day 2, Day 3, Day 4, Day 5 and Day 6. The baseline assessments were referred to assessments at Day 1. Maximum value in a day is reported, where a 'day' was defined as a 24 h period (Treatment Day).|Baseline (Day 1) to Day 6|Safety Population. Only those participants available at the specified time points were analyzed.|||Breaths/min||Standard Deviation|Mean
2666036|NCT01527110|Primary|Mean Oxygen Saturation (OS) of Participants Over Period|Vital signs of OS was assessed three times daily during the treatment period/hospitalization at Day 1, Day 2, Day 3, Day 4, Day 5 and Day 6. The baseline assessments were referred to assessments at Day 1. Minimum value in a day is reported, where a 'day' is defined as a 24 h period (Treatment Day).|Baseline (Day 1) to Day 6|Safety Population. Only those participants available at the specified time points were analyzed.|||Percent oxygen saturation||Standard Deviation|Mean
2666058|NCT01527045|Secondary|Number of Non-relapse Mortalities|Number of patients who died without relapsed/progressive disease.|1 Year post-transplant|One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2666037|NCT01527110|Primary|Mean Systolic and Diastolic Blood Pressure (SBP and DBP) of Participants Over Period|Vital signs of SBP and DBP were assessed three times daily during the treatment period/hospitalization at Day 1, Day 2, Day 3, Day 4, Day 5 and Day 6. The baseline assessments were referred to assessments at Day 1. Minimum value in a day for SBP is reported where a 'day' is defined as a 24 h period (Treatment Day). DBP is measured at the same time as minimum SBP.|Baseline (Day 1) to Day 6|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2666038|NCT01527110|Primary|Mean Heart Rate (HR) of Participants Over Period|Vital sign of HR was assessed three times daily during the treatment period/hospitalization at Day 1, Day 2, Day 3, Day 4, Day 5 and Day 6. The baseline assessments were referred to assessments at Day 1. Maximum value in a day is reported where a 'day' is defined as a 24 h period (Treatment Day).|Baeline (Day 1) to Day 6|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats/min||Standard Deviation|Mean
2666039|NCT01527110|Primary|Number of Participants of Treatment Emergent Toxicities in Clinical Chemistry and Hematology Over Period|The normal reference ranges for clinical chemistry and hematology parameters were ALT 5 to 45 IU/L, ALP 100 to 325 IU/L, creatine kinase 60 to 270 IU/L, AST 10 to 40 IU/L, creatinine 41.548 to 69.836 µmol/L, direct bilirubin 0 to 5.13 µmol/L, total bilirubin 3.42 to 20.52 µmol/L, calcium 2.0958 to 2.5948 mmol/L, CO2/ bicarbonate 19.2 to 27.1 mmol/L, chloride 98 to 108 mmol/L, magnesium 0.7809 to 1.0275 mmol/L, potassium 3.5 to 5 mmol/L, sodium 137 to 147 mmol/L, urea/ BUN 2.856 to 8.211 mmol/L, basophils 0 to 2%, eosinophils 0 to 8%, lymphocytes 18 to 49%, monocytes 2 to 10%, total neutrophils 40 to 75%, platelet count 140 to 340 GI/L, WBC count 3.3 to 9 GI/L, hemoglobin 135 to 175 g/L and haematocrit 0.397 to 0.524 ratio. Participants with treatment emergent toxicities for grade 3 (severe) and grade 4 (potentially life threatening) were assessed at Day 1, Day 3 and Day 5. Classification of the toxicities as potentially drug-related was done based on the investigator's judgment.|Day 1, Day 3 and Day 5|Safety Population|||Participants|||Count of Participants
2666040|NCT01527110|Primary|Number of Participants With Toxicity Shifts From Baseline in Hematology Parameters Over Period|The reference ranges for hematology parameters were basophils 0 to 2%, eosinophils 0 to 8%, lymphocytes 18 to 49%, monocytes 2 to 10%, total neutrophils 40 to 75%, platelet count 140 to 340 GI/L, WBC count 3.3 to 9 GI/L, hemoglobin 135 to 175 g/L and haematocrit 0.397 to 0.524 ratio. The baseline assessments were referred to assessments at Day 1. Number of participants with shifts between NR high, within NR and NR low values in hematology parameters from baseline (Day 1) at Day 3 and Day 5 is reported.|Baseline (Day 1), Day 3 and Day 5|Safety Population. The number of participants available at that particular time point were used for analysis.|||Participants|||Count of Participants
2666041|NCT01527110|Primary|Number of Participants With Toxicity Shifts From Baseline in Clinical Chemistry Over Period|The reference ranges for clinical chemistry parameters were ALT 5 to 45 IU/L, ALP 100 to 325 IU/L, creatine kinase 60 to 270 IU/L, AST 10 to 40 IU/L, creatinine 41.548 to 69.836 µmol/L, direct bilirubin 0 to 5.13 µmol/L, total bilirubin 3.42 to 20.52 µmol/L, calcium 2.0958 to 2.5948 mmol/L, CO2/ bicarbonate 19.2 to 27.1 mmol/L, chloride 98 to 108 mmol/L, magnesium 0.7809 to 1.0275 mmol/L, potassium 3.5 to 5 mmol/L, sodium 137 to 147 mmol/L and urea/ BUN 2.856 to 8.211 mmol/L. The baseline assessments were referred to assessments at Day 1. Number of participants with shifts between normal range (NR) high, within NR and NR low values in hematology parameters from baseline (Day 1) at Day 3 and Day 5 is reported.|Baseline (Day 1), Day 3 and Day 5|Safety Population. The number of participants available at that particular time point were used for analysis.|||Participants|||Count of Participants
2666042|NCT01527110|Primary|Mean Change Baseline in Hematocrit at the Indicated Time Points|Hematocrit was measured at Baseline, Day 3 and Day 5 during the treatment period. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value.|Baseline (Day 1), Day 3 and Day 5|Safety Population. The number of participants available at that particular time point were used for analysis.|||Ratio||Standard Deviation|Mean
2666043|NCT01527110|Primary|Mean Change From Baseline in Hemoglobin at the Indicated Time Points|Hemoglobin was measured at Baseline, Day 3 and Day 5 during the treatment period. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value.|Baseline (Day 1), Day 3 and Day 5|Safety Population. The number of participants available at that particular time point were used for analysis.|||g/L||Standard Deviation|Mean
2666044|NCT01527110|Primary|Mean Change From Baseline in Counts of WBC and Platelets at the Indicated Time Points|WBC and platelet counts were measured at Baseline, Day 3 and Day 5 during the treatment period. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value.|Baseline (Day 1), Day 3 and Day 5|Safety Population. Only those participants available at the specified time points were analyzed.|||GI/L||Standard Deviation|Mean
2666045|NCT01527110|Primary|Mean Change From Baseline in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes and Total Neutrophils at the Indicated Time Points|Percentages of basophils, eosinophils, lymphocytes, monocytes and total neutrophils were measured at Baseline, Day 3 and Day 5 during the treatment period. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value.|Baseline, Day 3 and Day 5|Safety Population. The number of participants available at that particular time point were used for analysis.|||Percent of blood cells||Standard Deviation|Mean
2666046|NCT01527110|Primary|Mean Change From Baseline in Sodium, Calcium, Potassium, Chloride, Magnesium, Carbon Dioxide Content/Bicarbonate and Urea/BUN at the Indicated Time Points|Calcium, potassium, chloride, magnesium, carbon dioxide content/bicarbonate, sodium and urea/BUN were measured at Baseline, Day 3 and Day 5 during the treatment period. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value.|Baseline (Day 1), Day 3 and Day 5|Safety Population. The number of participants available at that particular time point were used for analysis.|||mmol/L||Standard Deviation|Mean
2666252|NCT01525563|Secondary|Evolution of Pain During Menstruation From Baseline to End of Treatment|The scores for pain during menstruation were recorded on 11-point Likert scale on baseline and end of treatment where 0 means no pain, and 10 means worst pain.|6 months|The scores for pain during menstruation were recorded on 11-point Likert scale on baseline for all enrolled subjects and end of treatment where 0 means no pain, and 10 means worst pain.|||participants|||Number
2666047|NCT01527110|Primary|Mean Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at the Indicated Time Points|Creatinine, direct bilirubin and total bilirubin were measured at Baseline, Day 3 and Day 5 during the treatment period. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value.|Baseline (Day 1), Day 3 and Day 5|Safety Population. The number of participants available at that particular time point were used for analysis.|||µmol/L||Standard Deviation|Mean
2666048|NCT01527110|Primary|Mean Change From Baseline in ALT, ALP, Creatine Kinase and AST at the Indicated Time Points|ALT, ALP, creatine kinase and AST were measured at Baseline, Day 3 and Day 5 during the treatment period. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value.|Baseline (Day 1), Day 3 and Day 5|Safety population. The number of participants available at that particular time point were used for analysis.|||IU/L||Standard Deviation|Mean
2666049|NCT01527110|Primary|Mean Change From Baseline in Albumin and Total Protein at the Indicated Time Points|Albumin and total protein were measured at Baseline , Day 3 and Day 5 during the treatment period. The baseline assessments were referred to assessments at Day 1. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value.|Baseline (Day 1), Day 3 and Day 5|Safety Population. The number of participants available at that particular time point were used for analysis.|||g/L||Standard Deviation|Mean
2666050|NCT01527110|Primary|Number of Participants With Hematology Parameters of Basophiles, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, White Blood Cell(WBC) Count, Hemoglobin and Hematocrit Outside the Normal Reference Range at Any Time During Treatment|The reference ranges for hematology parameters were basophils 0 to 2 percentage (%), eosinophils 0 to 8%, lymphocytes 18 to 49%, monocytes 2 to 10%, total neutrophils 40 to 75%, platelet count 140 to 340 giga cells per liter (GI/L), WBC count 3.3 to 9 GI/L, hemoglobin 135 to 175 g/L and haematocrit 0.397 to 0.524 ratio. The baseline assessments were referred to assessments at Day 1. Assessments were done at Day 1, 3, and 5.|Baseline (Day 1) to Day 5|Safety Population|||Participants|||Count of Participants
2666051|NCT01527110|Primary|Number of Participants With Clinical Chemistry Parameters of Albumin and Total Protein Outside the Normal Reference Range at Any Time During Treatment|The reference ranges for clinical chemistry parameters were albumin 38 to 53 grams per liter (g/L) and total protein 67 to 83 g/L. The baseline assessments were referred to assessments at Day 1. Assessments were done at Day 1, 3 and 5.|Baseline (Day 1) to Day 5|Safety Population|||Participants|||Count of Participants
2666052|NCT01527110|Primary|Number of Participants With Clinical Chemistry Parameters of Calcium, Carbon Dioxide Content/ Bicarbonate, Chloride, Magnesium, Potassium, Sodium and Urea/ Blood Urea Nitrogen (BUN) Outside the Normal Reference Range at Any Time During Treatment|The reference ranges for clinical chemistry parameters were calcium 2.0958 to 2.5948 millimole per litre (mmol/L), carbon dioxide content/ bicarbonate 19.2 to 27.1 mmol/L, chloride 98 to 108 mmol/L, magnesium 0.7809 to 1.0275 mmol/L, potassium 3.5 to 5 mmol/L, sodium 137 to 147 mmol/L and urea/BUN 2.856 to 8.211 mmol/L. The baseline assessments were referred to assessments at Day 1. Assessments were done at Day 1, 3 and 5.|Baseline (Day 1) to Day 5|Safety Population|||Participants|||Count of Participants
2666053|NCT01527110|Primary|Number of Participants With Clinical Chemistry Parameters of Creatinine, Direct Bilirubin and Total Bilirubin Outside the Normal Reference Range at Any Time During Treatment|The reference ranges for clinical chemistry parameters were creatinine 41.548 - 69.836 micromole per litre (µmol/L), direct bilirubin 0 to 5.13 µmol/L and total bilirubin 3.42 to 20.52 µmol/L. The baseline assessments were referred to assessments at Day 1. Assessments were done at Day 1, 3 and 5.|Baseline (Day 1) to Day 5|Safety Population|||Participants|||Count of Participants
2666054|NCT01527110|Primary|Number of Participants With Clinical Chemistry Parameters of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Creatine Kinase and Aspartate Amino Transferase (AST) Outside the Normal Reference Range at Any Time During Treatment|The reference ranges for clinical chemistry parameters were ALT 5 to 45 international units per litre [IU/L]), ALP 100 to 325 IU/L, creatine kinase 60 to 270 IU/L and AST 10 to 40 IU/L. The baseline assessments were referred to assessments at Day 1. Assessments were done at Day 1, 3 and 5.|Baseline (Day 1) to Day 5|Safety Population|||Participants|||Count of Participants
2666055|NCT01527110|Primary|Number of Participants With Any Adverse Event (AE), Drug-related AE, Grade 3 and Grade 4 AE, Grade 3 and 4 Drug-related AE , AE Leading to Discontinuation of Study Drug or From Study, Serious AE (SAE), Drug-related SAE, Fatal AE and Drug-related Fatal AE|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalised ratio >1.5. The grading of AEs and SAE's for 3/4 (3= severe, 4= potentially life threatening ) and its classification as potentially drug-related was done based on the investigator's judgment.|Start of treatment (Day 1) up to follow-up (Day 33)|Safety Population comprised of all participants who received at least one dose of IV zanamivir.|||Participants|||Count of Participants
2666056|NCT01527045|Secondary|Number of Donors Discontinuing Atorvastatin Due to Toxicity|"The number of donors who prematurely discontinue atorvastatin therapy due to toxicity. Donors will be assessed for the following events:~Musculoskeletal and connective tissue disorders: grade 2-5~Hepatobiliary disorders: grade 2-5~Other unexpected events thought related to the use of atorvastatin; grade 2-5~In cases where the NCI criteria do not apply, intensity will be defined as:~Mild: awareness of symptom or sign, but easily tolerated~Moderate: discomfort is enough to cause interference with normal activities~Severe: inability to perform normal daily activities~Life threatening: immediate risk of death from the reaction as it occurred"|Prior to stem cell collection||||Participants|||Count of Participants
2666057|NCT01527045|Secondary|Number of Patients Surviving Overall|Number of patients surviving overall post-transplant|1 Year post-transplant|One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2666059|NCT01527045|Secondary|Number of Patients With Recurrent or Progressive Malignancy|"CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.~AML, ALL, MDS >5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease.~CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.~NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.~MM~≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions."|1 Year post-transplant|One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2666060|NCT01527045|Secondary|Number of Patients With Chronic Extensive GVHD|Number of patients who developed chronic extensive GVHD post-transplant. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD. Patients were evaluated as described in the National Institutes of Health (NIH) consensus project guidelines.|1 Year post-transplant|One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2666061|NCT01527045|Secondary|Number of Patients Requiring Secondary Systemic Immunosuppressive Therapy|Number of patients requiring systemic immunosuppressive therapy other than those used for prophylaxis and initial therapy.|1 Year post-transplant|One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2666062|NCT01527045|Secondary|Number of Patients With Grades II-IV Acute Graft-versus-host-disease (GVHD)|"Number of patients who developed acute GVHD post allogeneic transplant.~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL~bilirubin 3 - 5.9 mg/100 mL~bilirubin 6 - 14.9 mg/100 mL~bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death"|100 days post-transplant|One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2666063|NCT01527045|Primary|Number of Patients With Grade III-IV Acute Graft-versus-host Disease (GVHD) Post-transplant|"Number of patients who developed acute GVHD post allogeneic transplant.~aGVHD Stages~Skin:~a maculopapular eruption involving < 25% BSA~a maculopapular eruption involving 25 - 50% BSA~generalized erythroderma~generalized erythroderma w/ bullous formation and often w/ desquamation~Liver:~bilirubin 2.0 - 3.0 mg/100 mL~bilirubin 3 - 5.9 mg/100 mL~bilirubin 6 - 14.9 mg/100 mL~bilirubin > 15 mg/100 mL~Gut:~Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.~aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death"|100 days post-transplant|One subject on Reg A aborted transplant during conditioning due to donor related medical issue and subsequently went on to transplant on a different study. This subject was counted towards accrual but not evaluated with respect to outcome measures.|||Participants|||Count of Participants
2666064|NCT01527006|Secondary|The Clinical Global Impression of Change During the Overall Treatment Duration by Visit and at EOT [Extension Phase]|The Clinical Global Impression (CGI) evaluated perceived seizure frequency and severity, the occurrence of AEs, and overall functional status of the participant. The investigator performed the Clinical Global Impression of Severity for all participants at Baseline (Week 0). The evaluation used a 7-point scale where 1=normal, not at all ill and 7=extremely ill. The investigator performed the Clinical Global Impression of Change for all participants at planned visit and at EOT (the duration after the day of first study drug dose up to 7 days after the Extension Phase drug dose, inclusive). The evaluation used a 7-point scale where 1=very much improved and 7=very much worse. This tool was used to assess the participant's status over the 4-week period prior to the planned/EOT visits compared to Baseline (Week 0).|Week 0 (Baseline), Week 11, Week 28, Week 52 or EOT|The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.|||Participants|||Number
2666077|NCT01527006|Secondary|Palatability Questionnaire Assessment - How Does This Medicine Smell [Core Study]|The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very good, good, not good-not bad, bad, very bad).|Week 5 or at the time of early discontinuation|The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.|||Participants|||Number
2666561|NCT01522456|Other Pre-specified|User Preference Survey (Investigator)|"Response from investigator when asked: Which side of the face appears to be less irritated? Data collected from available participants."|Day 5, day 12, day 19, and day 22|Safety population|||participants|||Number
2666065|NCT01527006|Secondary|Seizure-free Rate During the Overall Treatment Duration [Extension Phase]|Seizure-free rate, defined as the percentage of participants who were seizure-free during the Maintenance Period. The percentage of participants who were seizure free was assessed from Week 1 of perampanel treatment through successive 13-week intervals for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures with baseline as Pretreatment Phase (Visit 1) of 2 weeks plus 4 weeks Prior to Pretreatment Phase. The data is presented as the percentage of participants.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52|The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.|||Percentage of participants|||Number
2666066|NCT01527006|Secondary|50 % Responder Rate During the Overall Treatment Duration by 13-week Intervals [Extension Phase]|Responder rate was defined as the proportion of participants with a 50% decrease in 28-day seizure frequency during the overall treatment duration. The percentage of responders was assessed from Week 1 of perampanel treatment through successive 13-week intervals for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures with baseline as Pretreatment Phase (Visit 1) of 2 weeks plus 4 weeks Prior to Pretreatment Phase. The data is presented as percentage of responders.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52|The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.|||Percentage of responders|||Number
2666067|NCT01527006|Secondary|Percentage Change From Baseline in Seizure Frequency Per 28 Days During the Overall Treatment Duration by 13-week Intervals [Extension Phase]|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. The percent change in 28-day seizure frequency from baseline was assessed for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. The data is presented as mean percent change +/- standard deviation.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Weeks 1-13, Weeks 14-26, Weeks 27-39, and Weeks 40-52|The Full Analysis Set included all subjects who took at least 1 dose of perampanel during the Extension Phase, and had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to Pretreatment Phase (Visit 1) of the Core Study and had any seizure frequency data during the Extension Phase.|||Percent change||Full Range|Median
2666068|NCT01527006|Other Pre-specified|The Effect of the Most Common Concomitant AEDs on Population PK Parameters: Tmax|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.||||||
2666069|NCT01527006|Other Pre-specified|The Effect of the Most Common Concomitant AEDs on Population PK Parameters: Cmax|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.||||||
2666070|NCT01527006|Other Pre-specified|The Effect of the Most Common Concomitant AEDs on Population PK Parameters: AUC|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.||||||
2666071|NCT01527006|Other Pre-specified|The Effect of Demographics on Population PK Parameters: Tmax|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.||||||
2666072|NCT01527006|Other Pre-specified|The Effect of Demographics on Population PK Parameters: Cmax|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.||||||
2666073|NCT01527006|Other Pre-specified|The Effect of Demographics on Population PK Parameters: AUC|This outcome was not assessed in the study.|11 weeks|This outcome was not assessed in the study.||||||
2666074|NCT01527006|Secondary|Palatability Questionnaire Assessment - Would You/Your Child Have Preferred This Medicine to Have Been Flavored, e.g. Fruity [Core Study]|The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the three options (yes, no and don't mind).|Week 5 or at the time of early discontinuation|The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.|||Participants|||Number
2666075|NCT01527006|Primary|Steady-state Average Concentration (C av,ss) of Perampanel [Core Study]|C av,ss was calculated as 'Dose (mg)/Dosing Interval (24 h)/(CL/F [L/h]) x 1000'. C av,ss during a dosing interval was dose-normalized to 0.12 mg/kg in participants aged ≥ 2 to less than 12 years (intended to correspond to 8 mg/70 kg in adults/adolescents). Blood samples were collected at day 8, Day 36, Day 64 , and Day 78. C av,ss values were calculated for each visit and averaged to derive the total C av,ss value per arm. Data was analysed for 2 categories: CYP3A4/5 inducers (carbamazepine, oxcarbazepine and phenytoin) and non-inducers. Data is presented as mean Liter per hour +/- standard deviation.|From Day 8 up to Day 78|The PK analysis set, defined as participants with at least 1 pharmacokinetic assessment of perampanel with a documented dosing history.|||ng/mL||Standard Deviation|Mean
2666076|NCT01527006|Secondary|Palatability Questionnaire Assessment - Based on Its Taste, Smell, and How it Felt in the Mouth, How Easy or Difficult Was it for You / Your Child to Take This Medicine Every Day [Core Study]|The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very easy, easy, neither easy or difficult, difficult and very difficult).|Week 5 or at the time of early discontinuation|The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.|||Participants|||Number
2666123|NCT01526785|Primary|Percentage of Participants Who Were Clinically Stable or Improved at Week 52|Clinical stability was defined as absence of death due to disease progression or new dependency on invasive ventilation and; decline in cardiac status, motor function, and pulmonary function from baseline.|Week 52|Full analysis population. Number of participants analyzed = participants with available data at Week 52 for this outcome.|||percentage of participants||95% Confidence Interval|Number
2666078|NCT01527006|Secondary|Palatability Questionnaire Assessment - How Does This Medicine Taste [Core Study]|The Palatability Questionnaire was answered directly by participants in Cohort ( ≥ 7 to ≤ 12 years) and indirectly by participants in Cohort ( ≥ 2 to ≤ 7 years) via their parents/caregivers. Participants selected their response from one of the five options (very good, good, not good-not bad, bad, very bad).|Week 5 or at the time of early discontinuation|The Safety Analysis Set, defined as participants who received study drug treatment and had at least 1 postdose safety assessment.|||Participants|||Number
2666079|NCT01527006|Secondary|Number of Participants With Treatment Emergent Non-Serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Perampanel|An AE was defined as any untoward medical occurrence in a participant administered with the study drug. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The details of the adverse events are presented in the safety section of the results.|For each participant, from the first treatment dose till 30 days after the last dose or up to Week 15 for Core Study and Week 56 for the Extension Phase|The Safety Analysis Set included all subjects who took at least 1 dose of perampanel and had at least 1 postdose safety assessment during the Core Study and the Extension Phase.|||Participants|||Number
2666080|NCT01527006|Secondary|The Clinical Global Impression of Change at the End of Treatment (EOT) [Core Study]|The Clinical Global Impression (CGI) evaluated perceived seizure frequency and severity, the occurrence of AEs, and overall functional status of the participant. The investigator performed the Clinical Global Impression of Severity for all participants at Baseline (Week 0). The evaluation used a 7-point scale where 1=normal, not at all ill and 7=extremely ill. The investigator performed the Clinical Global Impression of Change for all participants at the EOT (the duration after the day of first study drug dose up to 7 days after the last Core Phase drug dose, inclusive). The evaluation used a 7-point scale where 1=very much improved and 7=very much worse. This tool was used to assess the participant's status over the 4-week period prior to its completion compared to Baseline (Week 0).|Week 0 (Baseline), Week 11 or EOT|The Full Analysis Set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.|||Participants|||Number
2666081|NCT01527006|Secondary|Seizure-free Rate During the Maintenance Period [Core Study]|Seizure-free rate, defined as the percentage of participants who were seizure-free during the Maintenance Period. SG = Secondary Generalization.|Week 9 to Week 11|The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.|||Percentage of participants|||Number
2666082|NCT01527006|Secondary|50% Responder Rate During the Maintenance Period-LOCF [Core Study]|Responder rate was defined as the proportion of participants with a 50% decrease in 28-day seizure frequency during the Maintenance Period compared to Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 Weeks Prior to Pretreatment Phase] for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. The data is presented as percent responders. LOCF = Last Observation Carried Forward.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 9 to 11|The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.|||Percent responders|||Number
2666083|NCT01527006|Primary|Apparent Clearance (CL/F) of Perampanel [Core Study]|CL/F was defined as the volume of plasma cleared of the drug per unit time. Blood samples were collected at day 8, Day 36, Day 64 , and Day 78. The CL/F values were calculated for each visit and averaged to derive the total CL/F value per arm. Data was analyzed for 2 categories: CYP3A4/5 inducers (carbamazepine, oxcarbazepine and phenytoin) and non-inducers. Data is presented as mean Liter per hour +/-standard deviation.|From Day 8 up to Day 78|The pharmacokinetic (PK) analysis set, defined as participants with at least 1 pharmacokinetic assessment of perampanel with a documented dosing history.|||Liter per hour||Standard Deviation|Mean
2666084|NCT01527006|Secondary|Percent Change From Baseline in Seizure Frequency Per 28 Days in Treatment Phase [Core Study]|Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated the number of seizures over the time interval multiplied by 28 and divided by the number of days in the interval. The percent change in 28-day seizure frequency from baseline was assessed for overall seizures, overall partial seizures, overall generalized seizures, and unclassified seizures. The data is presented as mean percent change +/- standard deviation.|Baseline [2 weeks Pretreatment Phase (Visit 1) plus 4 weeks Prior to Pretreatment Phase], Week 0 to Week 15|The full analysis set, defined as participants who received study drug, had any seizure frequency data during the 2-week Pretreatment Phase plus the 4 weeks prior to the Pretreatment Phase (Visit 1), and during the Treatment Phase of the Core Study.|||Percent change||Full Range|Median
2666085|NCT01526928|Secondary|Objective Response Rate (ORR), Duration of Response (DOR) and Progression-Free Survival (PFS) Per RECIST Version 1.1 as Determined by IRR|Objective response rate (ORR), duration of response (DOR) and progression-free survival (PFS) per RECIST Version 1.1 as determined by independent radiology review (IRR)|Cycle 1 Day 1 to End of Treatment / End of Follow-up|Tumor scans were collected for independent evaluation, however ORR, DOR and PFS analyses were not performed by the central reader since the sponsor deemed not necessary following early study termination. Therefore, all IRR outcome measures were not collected and can not be reported.||||||
2666156|NCT01526057|Secondary|Percentage of Participants by Anti-drug Antibody (ADA) Status|Presence of anti-rituximab antibodies in blood. Participants with a positive antibody status at any time during the study were defined as having overall positive antibody status; participants with a negative antibody status throughout the study were defined as having overall negative antibody status.|Days 1 up to Day 169.|mITT population.|||Percentage of participants|||Number
2666086|NCT01526928|Secondary|QTcF Value Change From Baseline|QTcF value change from baseline by daily dose (corrected using Fridericia's method, QTcF). To evaluate the effects of rociletinib on the QT (interval from Q wave to T wave)/QTc (interval corrected for heart rate) interval, all patients underwent serial ECG monitoring at Baseline, on Cycle 1 Day 1, Cycle 1 Day 15, on Day 1 of all subsequent cycles, at the EOT Visit, and as clinically indicated. Worst post-baseline QTcF value was used to categorize each patient.|Screening to End of Treatment, up to approximately 42 months|Safety population by daily dose|||Participants|||Count of Participants
2666087|NCT01526928|Secondary|QTcF Values Post Baseline by Daily Dose|Frequency of QT interval prolongation by daily dose (corrected using Fridericia's method, QTcF). To evaluate the effects of rociletinib on the QT (interval from Q wave to T wave)/QTc (interval corrected for heart rate) interval, all patients underwent serial ECG monitoring at Baseline, on Cycle 1 Day 1, Cycle 1 Day 15, on Day 1 of all subsequent cycles, at the EOT Visit, and as clinically indicated. Worst post-baseline QTcF value was used to categorize each patient.|Screening to End of Treatment, up to approximately 42 months|Safety population by daily dose|||Participants|||Count of Participants
2666088|NCT01526928|Secondary|Food Effect on PK of Rociletinib - T 1/2|T 1/2 = elimination half-life following administration of rociletinib. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.|Day -7 prior to Cycle 1 Day 1, or approximately 7 days|A subset of 3 patients treated with rociletinib 150 mg FB capsules. Data did not allow the calculation of half-life with high fat mean in 2 patients.|||Hours||Standard Deviation|Mean
2666089|NCT01526928|Secondary|Food Effect on PK of Rociletinib - C24|C24 = rociletinib plasma concentration at 24 hours post the morning dose. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.|Day -7 prior to Cycle 1 Day 1, or approximately 7 days|A subset of 3 patients treated with rociletinib 150 mg FB capsules|||ng/mL||Standard Deviation|Mean
2666090|NCT01526928|Secondary|Food Effect on PK of Rociletinib - AUC 0-24|AUC 0-24 = area under the curve from 0 to 24 hours. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.|Day -7 prior to Cycle 1 Day 1, or approximately 7 days|A subset of 3 patients treated with rociletinib 150 mg FB capsules. AUC could not be determined for 1 patient in the Fed arm.|||ng*hr/mL||Standard Deviation|Mean
2666091|NCT01526928|Secondary|Food Effect on PK of Rociletinib - Tmax|Tmax = time to maximum concentration following administration of rociletinib. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.|Day -7 prior to Cycle 1 Day 1, or approximately 7 days|A subset of 3 patients treated with rociletinib 150 mg FB capsules|||Hours||Full Range|Median
2666092|NCT01526928|Secondary|Food Effect on PK of Rociletinib - Cmax|Cmax = maximum concentration following administration of rociletinib. The effect of food on rociletinib PK parameters was assessed over a 24-hour period in blood samples from a subset of 3 patients. These patients were given a single dose of rociletinib 150mg FB 1 week prior (Day -7) to the start of continuous daily dosing after fasting. On Day 1 of Cycle 1, patients consumed a high-fat, high-calorie breakfast at the study site prior to receiving rociletinib. On each day, patients underwent blood sampling for PK at the specified time points.|Day -7 prior to Cycle 1 Day 1, or approximately 7 days|A subset of 3 patients treated with rociletinib 150 mg FB capsules|||ng/mL||Standard Deviation|Mean
2666093|NCT01526928|Secondary|PK Profile of Rociletinib - T 1/2|T 1/2 = elimination half-life following administration of rociletinib|Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days|PK parameters were assessed in a subset of patients treated with rociletinib. For some parameters, the number analyzed at Day 1 and Day 15 differs from the overall number analyzed based on the number of evaluable samples collected at each time point. Elimination half-life was not calculated for patients in the 400 mg TID treatment group.|||Hours||Standard Deviation|Mean
2666094|NCT01526928|Secondary|PK Profile of Rociletinib - AUC 0-24|AUC 0-24 = area under the curve from 0 to 24 hours|Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days|PK parameters were assessed in a subset of patients treated with rociletinib. For some parameters, the number analyzed at Day 1 and Day 15 differs from the overall number analyzed based on the number of evaluable samples collected at each time point. AUC was not calculated for patients in the 400 mg TID treatment group.|||ng*hr/mL||Standard Deviation|Mean
2666095|NCT01526928|Secondary|PK Profile of Rociletinib - Tmax|Tmax = time to maximum concentration following administration of rociletinib|Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days|PK parameters were assessed in a subset of patients treated with rociletinib. For some parameters, the number analyzed at Day 1 and Day 15 differs from the overall number analyzed based on the number of evaluable samples collected at each time point.|||Hours||Full Range|Median
2666096|NCT01526928|Secondary|PK Profile of Rociletinib - Cmax|Cmax = maximum concentration following administration of rociletinib|Cycle 1 Day 1 to Cycle 1 Day 15, or approximately 15 days|PK parameters were assessed in a subset of patients treated with rociletinib. For some parameters, the number analyzed at Day 1 and Day 15 differs from the overall number analyzed based on the number of evaluable samples collected at each time point.|||ng/mL||Standard Deviation|Mean
2666562|NCT01522456|Secondary|Tolerability at Day 22 (Dryness)|Tolerability assessments at day 22 for dryness|Day 22|Safety population|||participants|||Number
2666097|NCT01526928|Secondary|Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by Investigator Review (invPFS)|Progression-free survival was calculated as the number of days from the date of the first dose of study drug to the date of disease progression or death due to any cause + 1. Patients without a documented event of disease progression were censored on the date of their last adequate tumor assessment (i.e., radiologic assessment) or date of first dose of study drug if no tumor assessments have been performed. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|Cycle 1 Day 1 to End of Treatment, up to approximately 42 months|The overall number of patients analyzed contains centrally determined T790M positive patients only. There are 2 less patients in the <900 mg BID FB group, and 1 less patient in each of the 500 and 625 mg BID dose groups because they were not followed for PFS.|||months||95% Confidence Interval|Median
2666098|NCT01526928|Secondary|Overall Survival (OS) Determined by Investigator Assessment|Overall survival was calculated as 1+ the number of days from the first dose of study drug to death due to any cause. Patients without a documented date of death were censored on the date the patient was last known to be alive.|Cycle 1 Day 1 to date of death, assessed up to 42 months|The overall number of patients analyzed contains centrally determined T790M positive patients only. There are 2 less patients in the <900 mg BID FB group, and 1 less patient in each of the 500, 625 and 750 mg BID dose groups because they were not followed for OS.|||months||95% Confidence Interval|Median
2666099|NCT01526928|Primary|Dose Limiting Toxicity (DLT) Incidence|The number of Phase 1 patients who experienced dose limiting toxicities after one cycle (21 days) of study drug.|Cycle 1 Day 1 to Cycle 1 Day 21|The dose limiting toxicity (DLT) evaluable population includes all patients who have completed Cycle 1, and who were enrolled while the dose escalation (Phase 1) part of the study was ongoing.|||Participants|||Count of Participants
2666100|NCT01526928|Primary|Duration of Response (DOR) in T790M Positive Patients According to RECIST Version 1.1 as Determined by Investigator Assessment|Duration of Response in patients with a T790M mutation (determined by central lab) with confirmed response per investigator. The DOR for complete response (CR) and partial response (PR) was measured from the date that any of these best responses is first recorded until the first date that progressive disease (PD) is objectively documented. For patients who continue treatment post-progression, the first date of progression was used for the analysis.|Cycle 1 Day 1 to End of Treatment, up to approximately 36 months|The DOR was measured only in T790M positive patients with a Complete Response (CR) or Partial Response (PR). There were no responders in the Rociletinib <900 mg BID treatment group so DOR is not applicable and thus not reported.|||Days||95% Confidence Interval|Median
2666101|NCT01526928|Primary|Percentage of T790M Positive Patients With Confirmed Response Per Investigator|Percentage of patients with a T790M mutation (determined by central lab) with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression or recurrence. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR),at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.|Cycle 1 Day 1 to End of Treatment, up to approximately 42 months|Intent-to-treat: All randomized patients who are confirmed by central lab to be T790M positive|||Participants|||Count of Participants
2666102|NCT01526902|Secondary|Subjective Vision Assessments: High Contrast Near Visual Quality|Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.|After 1 hour of lens wear|Per Protocol|||units on a scale||Standard Deviation|Mean
2666103|NCT01526902|Primary|Objective Vision Assessments: High Contrast Near Visual Acuity|Tested with charts set at near point (40cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.|After 1 hour of lens wear|Per Protocol|||logMAR units||Standard Deviation|Mean
2666104|NCT01526902|Primary|Objective Vision Assessments: High Contrast Intermediate Visual Acuity|Tested with charts at intermediate distance (100cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.|After 1 hour of lens wear|Per Protocol|||logMAR units||Standard Deviation|Mean
2666105|NCT01526902|Secondary|Subjective Vision Assessments: High Contrast Intermediate Visual Quality|Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.|After 1 hour of lens wear|Per Protocol|||units on a scale||Standard Deviation|Mean
2666106|NCT01526902|Secondary|Subjective Overall Vision: High Contrast Distance Visual Quality|Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.|After 1 hour of lens wear|Per Protocol|||units on a scale||Standard Deviation|Mean
2666107|NCT01526902|Primary|Objective Vision Assessments: High Contrast Distance Visual Acuity|Tested with charts distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.|After 1 hour of lens wear|Per Protocol|||logMAR units||Standard Deviation|Mean
2666108|NCT01526889|Secondary|Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period|Percent change from baseline (using each patient's pre-dose value as baseline) in total C5 concentrations.|Day 2, 15, 29, 43, 57 and, 85 (end of the study)|Pharmacodynamic (PD) analysis set: All patients in the safety analysis set with EVALUABLE pharmacodynamics (PD) data (Total C5) and with no major protocol deviations that had an impact on PD data were included in the PD analysis set.|||Percent change in C5||Standard Deviation|Mean
2666109|NCT01526889|Secondary|Number of Participants With or Without Anti-LFG316 Antibodies|"Blood will be collected at each visit for the profiling of serum drug concentrations. The summary of immunogenicity (IG) by visit . The immunogenicity data (presence/absence of anti-LFG316 antibodies [anti-drug antibodies]).~NO: No immunogenicity; YES: Positive immunogenicity."|Throughout the study (treatment and extension period), up to day 271|Pharmacokinetic analysis set: All patients in the safety analysis set with evaluable PK data and with no protocol deviations affecting PK data.|||Participants|||Count of Participants
2666110|NCT01526889|Secondary|Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period|anterior chamber cells score (ACCS) with the scores being 0 (≤ 1 cell), 0.5 (1 to 5 aqueous cells), 1 (6 to 15 aqueous cells), 2 (16 to 25 aqueous cells), 3 (26 to 50 aqueous cells), 4 (>50 aqueous cells).|Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)|Efficacy 1 analysis set|||Participants|||Count of Participants
2666111|NCT01526889|Secondary|Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period|Chorioretinal lesions is a sign of uveitis.|Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)|Efficacy 1 analysis set|||Participants|||Count of Participants
2666112|NCT01526889|Secondary|Number of Patients With Macular Edema in Study Eye - Treatment Period|Macular edema is a sign of uveitis.|Day 85 (end of study)|Efficacy 1 analysis set|||Participants|||Count of Participants
2666113|NCT01526889|Secondary|Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period|"Visual acuity was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) eye charts under ETDRS conditions.~ETDRS best-corrected visual acuity was obtained in each eye separately under certified ETDRS conditions. This assessment was to be performed prior to pupil dilation. The number of letters read correctly (for each eye) was recorded.~BCVA is based on the number of letters read correctly."|Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)|Efficacy 1 analysis set|||letters||Standard Deviation|Mean
2666114|NCT01526889|Secondary|Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period|"Vitreous haze score (based on funduscopic exam): 0, 0.5/Trace, 1+, 2+, 3+, 4+~Vitreous haze score (scale of 0 to 4) with a score of 4 being the most hazed."|Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)|Efficacy 1 analysis set|||Participants|||Count of Participants
2666115|NCT01526889|Primary|Number of Participants With Remission in Study Eye - Treatment Period|"Remission (complete response) was defined as any patient who had:~a vitreous haze score of 0 or 0.5 (scale of 0 to 4) in the study eye, AND~an anterior chamber cell score of 0 (scale of 0 to 4), AND~no chorioretinal lesions in the study eye, AND~was off all immune modulatory therapy (systemic, corticosteroids and topical), AND~without any worsening of uveitis during the trial."|Day 85 (end of study)|Efficacy 1 analysis set|||Participants|||Count of Participants
2666116|NCT01526889|Primary|Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye|"Response rate as defined by:~An improvement of 2 or more steps in vitreous haze (scale of 0 to 4), relative to baseline OR~An improvement of 10 or more letters in visual acuity (VA), relative to baseline OR~An improvement of 2 or more steps in anterior chamber cells (ACC) score (scale of 0 to 4), relative to baseline OR~Absence of chorioretinal lesions as determined by the investigator"|Day 85 (end of study)|Efficacy 1 analysis set: All patients in the safety analysis set who received any study treatment (LFG316 or conventional treatment) with evaluable efficacy data for at least one efficacy endpoint(s) (ocular assessments) and with no major protocol deviations that had an impact on efficacy data.|||Participants|||Number
2666117|NCT01526785|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Week 52- At Sitting Position|Percent predicted FVC values are reported. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%.|Baseline, Week 52|Full analysis population. Number of participants analysed = participants with baseline and Week 52 FVC data.|||percent predicted FVC||Standard Deviation|Mean
2666118|NCT01526785|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Week 52- At Supine Position|Percent predicted FVC values are reported. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in litres. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%.|Baseline, Week 52|Full analysis population. Number of participants analysed = participants with baseline and Week 52 FVC data.|||percent predicted FVC||Standard Deviation|Mean
2666119|NCT01526785|Secondary|Change From Baseline on Gross Motor Function Measure-88 (GMFM-88) at Week 52|GMFM-88 (88-item measure to detect gross motor function) consists of 5 components, each measured on a 4-point Likert scale.The score for each dimension was expressed as a percentage of the maximum score for that dimension.Total score ranges from 0% to 100%, where higher scores indicate better motor functions.|Baseline, Week 52|Full analysis population. Number of participants analysed = participants with baseline and Week 52 GMFM-88 data.|||percentage of total score||Standard Deviation|Mean
2666120|NCT01526785|Secondary|Change From Baseline on Left Ventricular Mass Z-Score (LVM-Z) at Week 52|Z-Scores indicate the number of standard deviations (SD) from the mean in a normal distribution. A negative change from baseline indicates an increase in LVM-Z score. The normal range is -2 to 2 and greater than 2 may indicate left ventricular hypertrophy.|Baseline, Week 52|Full analysis population. Number of participants analyzed = participants with available data at Week 52 for this outcome.|||Z score||Standard Deviation|Mean
2666121|NCT01526785|Secondary|Invasive Ventilator-Free Survival Rate at Week 52|Percentage of participants, who were invasive ventilator-free at week 52, are reported. Invasive ventilation was defined as mechanical ventilatory support applied with the use of an endotracheal tube or tracheostomy. Invasive ventilator-free survival rate was calculated by Kaplan-Meier estimate.|Week 52|Full analysis population. Number of participants analyzed = participants with available data at Week 52 for this outcome.|||percentage of participants||95% Confidence Interval|Number
2666122|NCT01526785|Secondary|Survival Rate at Week 52|Percentage of participants who were alive at Week 52, were reported. Survival rate was calculated by Kaplan-Meier estimate.|Week 52|Full analysis population.|||percentage of participants||95% Confidence Interval|Number
2666563|NCT01522456|Secondary|Tolerability at Day 22 (Erythema)|Tolerability assessments at day 22 for erythema|Day 22|Safety population|||participants|||Number
2666124|NCT01526733|Secondary|Duration of Insulin Action (AUMC[0-360]/AUC[0-360])|Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC[0-360]) by the area under the concentration versus time curve (AUC[0-360]). AUCM is the total area under the first moment curve. First moment curve is obtained by plotting concentration-time versus time. It can be used to measure how long a drug stays in the body. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|10 minutes predose; 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable AUMC(0-360)/AUC(0-360) data.|||ratio||Standard Deviation|Mean
2666125|NCT01526733|Secondary|Area Under the Glucose Concentration Curve (AUC[0-360])|Area under the glucose concentration curve from 0 to 360 minutes (AUC[0-360]) is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|30 minutes and 10 minutes predose; 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable AUC(0-360) data.|||picomoles*minutes/liter||Standard Deviation|Mean
2666126|NCT01526733|Secondary|Time to 50% Total Glucose Infused (50%Gtot)|Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable 50%Gtot data.|||minutes||Standard Deviation|Mean
2666127|NCT01526733|Secondary|Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max)|Early and late tGIR50%max are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable early and late tGIR50%max data.|||minutes||Standard Deviation|Mean
2666128|NCT01526733|Secondary|Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax)|Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable tGIRmax data.|||minutes||Standard Deviation|Mean
2666129|NCT01526733|Secondary|Maximum Glucose Infusion Rate (GIRmax)|Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.|0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable GIRmax data.|||milligrams/kilogram/minute||Standard Deviation|Mean
2666130|NCT01526733|Primary|Early Insulin Exposure (%AUC[0-60])|Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve [AUC{0 360}]) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, and 60 minutes postdose during a euglycemic clamp.|10 minutes predose; 0, 5, 10, 15, 20, 30, 45, and 60 minutes postdose on Days 1 and 4|Participants who completed both phases of the study and with evaluable %AUC(0-60) data.|||percentage of AUC(0-60)||Standard Deviation|Mean
2666131|NCT01526629|Primary|Remote Follow-up as an Alternative to Onsite Visit|Evaluate the percentage of patients who had a successful remote follow up, as an alternative to onsite visit for patients implanted with a fully automatic ICD|13 months||||Participants|||Count of Participants
2666132|NCT01526577|Primary|Platelet Aggregation Test, Bleeding Test||pre-dose, up to 1 day post-dose|||||||
2666133|NCT01526577|Secondary|AUC||pre-dose, up to 3 days post-dose|||||||
2666134|NCT01526577|Primary|Pharmacodynamic Measurement|"Inhibition of platelet aggregation (IPA) was analized by the platelet aggregation test.~* Among the time points that platelet aggregation rate was meausred, the result only at 8h post dosing was provided in result section."|1D 0, 2, 8, 24h for single dose study / 1D and 7D 0, 2, 8, 12, 24h for multiple dose study||||percentage of platelet inhibition|||Number
2666135|NCT01526577|Primary|Adverse Events of LC23-1306||7 days (plus or minus 1 day)|||||||
2666136|NCT01526551|Primary|Number of Students Who Completed HPV Vaccination as a Result of the School-based Program|Number of students who returned a parental consent form and ultimately completed the full HPV vaccination series as a result of the school-based program|August 2012 -- June 2013||||participants|||Number
2666137|NCT01526551|Primary|Number of Students Who Initiated the HPV Vaccine Series as a Result of the School-based Program|Number of students who returned a parental consent form and ultimately initiated the HPV vaccine series as a result of the school-based program|August 2012-June 2013||||participants|||Number
2666138|NCT01526538|Secondary|Learning Task by Itami and Uno||At the baseline laboratory visit||||% correct||Standard Error|Mean
2666139|NCT01526538|Primary|Medication Side-effects|self-report of medication side effects (Units of Measure is the count of specific reported effects)|1 month post-treatment.||||Adverse event reports|||Number
2666140|NCT01526538|Primary|Urinalysis Benzoylecgonine (Cocaine Metabolite)(ng/ml)|The primary outcome for this study will be post-treatment continuous abstinence, as assessed by urinalysis results|1 month post-treatment||||ng/ml||Standard Deviation|Mean
2666141|NCT01526343|Primary|Freedom From Atrial Tachyarrhythmias (ATAs)||ILR monitoring at 12 months|Participants with available data at 1 year and who were compliant with use of each device.|||Participants|||Number
2666142|NCT01526343|Primary|Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals||ILR monitoring obtained at 3, 6 and 12 months||||ATA episodes|||Number
2666143|NCT01526213|Primary|Primary Pharmacokinetic Measure: Area Under the Curve (AUC)||0-72 hours||||micromolar*hr||Full Range|Geometric Mean
2666220|NCT01525628|Primary|Cmax of Caffeine|Maximum concentration of an analyte in plasma|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2666144|NCT01526148|Secondary|Lithium vs. Quetiapine Effects on General Cardiovascular Disease Risk as Measured by Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)|Change in homeostatic model assessment for insulin resistance (HOMA-IR) from screening to end of study. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone in the body. The HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. The higher the score, the higher the level of insulin resistance.|Screening and Week 16||||IR Score||Standard Deviation|Mean
2666145|NCT01526148|Primary|Time to Study Discontinuation|The time, as measured in number of days, for discontinuation due to all causes will be measured and used as the primary outcome measure|Week 16||||days||95% Confidence Interval|Mean
2666146|NCT01526057|Secondary|Percent Change From Baseline in HAQ-DI Score by Visit|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 3, 5, 9, 13, 17, 21 and 25|"mITT population. Overall Number of Participants Analyzed= participants evaluable for this outcome measure. Number Analyzed = participants evaluable at specified time points."|||Percentage change||Standard Deviation|Mean
2666147|NCT01526057|Secondary|Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Visit|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Baseline, Week 3, 5, 9, 13, 17, 21 and 25|"mITT population. Number Analyzed = participants evaluable at specified time points."|||Units on a scale||Standard Deviation|Mean
2666148|NCT01526057|Secondary|Percentage of Participants With DAS Remission (DAS <2.6) by Visit|DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP <2.6 implied remission. p-value of 9999 indicates p-value is not applicable.|Weeks 3, 5, 9, 13, 17, 21 and 25|"mITT population. Number Analyzed = participants evaluable at specified time points."|||Percentage of participants|||Number
2666149|NCT01526057|Secondary|Percentage of Participants With Low Disease Activity Score (DAS <=3.2) by Visit|DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity. p-value of 9999 indicates p-value is not applicable.|Weeks 3, 5, 9, 13, 17, 21 and 25|"mITT population. Number Analyzed = participants evaluable at specified time points."|||Percentage of participants|||Number
2666150|NCT01526057|Secondary|Percentage of Participants With No EULAR Response Based on DAS28 by Visit|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6, or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Weeks 3, 5, 9, 13, 17, 21 and 25|"mITT population. Number Analyzed = participants evaluable at specified time points."|||Percentage of Participants|||Number
2666151|NCT01526057|Secondary|Percentage of Participants With Moderate EULAR Response Based on Disease Activity Score Based on DAS28 by Visit|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6, or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Weeks 3, 5, 9, 13, 17, 21 and 25|"mITT population. Number Analyzed = participants evaluable at specified time points."|||Percentage of participants|||Number
2666152|NCT01526057|Secondary|Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on Disease Activity Score Based on 28-Joint Count (DAS28) by Visit|The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6, or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.|Weeks 3, 5, 9, 13, 17, 21 and 25|"mITT population. Number Analyzed = participants evaluable at specified time points."|||Percentage of participants|||Number
2666153|NCT01526057|Secondary|Percent Change From Baseline in DAS28-CRP by Visit|DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP less than or equal to (≤)3.2 implied low disease activity, DAS28-CRP greater than (>)3.2 to ≤5.1 implied moderate to high disease activity, and DAS28-CRP less than (<)2.6 implied remission.|Baseline and Weeks 3, 5, 9, 13, 17, 21 and 25|"mITT population. Number Analyzed = participants evaluable at specified time points."|||Percent change||Standard Deviation|Mean
2666154|NCT01526057|Secondary|Change From Baseline in Disease Activity Score Based on 28-Joint Count and C-Reactive Protein (DAS28-CRP)|DAS28-CRP was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP less than or equal to (≤)3.2 implied low disease activity, DAS28-CRP greater than (>)3.2 to ≤5.1 implied moderate to high disease activity, and DAS28-CRP less than (<)2.6 implied remission.|Baseline and Weeks 3, 5, 9, 13, 17, 21 and 25|"mITT population. Number Analyzed = participants evaluable at specified time points."|||Units on a scale||Standard Deviation|Mean
2666155|NCT01526057|Secondary|Percentage of Participants With Neutralizing Antibody (NAb) in Participants With a Positive ADA by Visit||Day 1 up to Day 169|mITT population. Only participants with a positive ADA status were included in the analysis.|||Percentage of participants|||Number
2666157|NCT01526057|Secondary|Percentage of Participants With ACR 50% Improvement (ACR50) Response by Visit|"ACR50 response: ≥50% improvement in tender joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.~Non-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participants who rolled over to the extension study were not included in the non-responder imputation from that point on."|Weeks 3, 5, 9, 13, 17, 21 and 25|"mITT population. Number Analyzed = participants evaluable at specified time points."|||Percentage of Participants|||Number
2666158|NCT01526057|Secondary|Percentage of Participants With ACR 70% Improvement (ACR70) Response by Visit|"ACR70 response: ≥70% improvement in tender joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.~Non-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participantss who rolled over to the extension study were not included in the non-responder imputation from that point on."|Weeks 3, 5, 9, 13, 17, 21 and 25 (EOT)|"mITT population. Number Analyzed = participants evaluable at specified time points."|||Percentage of participants|||Number
2666159|NCT01526057|Secondary|Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response by Visit|"ACR20 response: greater than or equal to (≥)20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).~Non-responder imputation categorized participants as having a non-response if they did not have data available at a visit due to missing data or study discontinuation. Participants who rolled over to the extension study were not included in the non-responder imputation from that point on."|Weeks 3, 5, 9, 13, 17, 21 and 25|"mITT population. Number Analyzed = participants evaluable at specified time points."|||Percentage of participants|||Number
2666160|NCT01526057|Secondary|Percent (%) Change From Baseline in Circulating IgM by Visit (g/L)|The percentage change from Baseline in circulating IgM by visit.|Baseline and Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21 and 25|"mITT population. Overall Number of Participants Analyzed= participants evaluable for this outcome measure. Number Analyzed = participants evaluable at specified time points."|||percent change||Standard Deviation|Mean
2666161|NCT01526057|Secondary|Baseline and Change From Baseline in Circulating Immunoglobulin-M (IgM) by Visit (Grams Per Liter (g/L])|The level of IgM in serum at Baseline and the change from Baseline at each subsequent visit.|Baseline and Weeks 1, 2, 3, 4, 5, 9, 13, 17, 21 and 25 (EOT)|"mITT population. Number Analyzed = participants evaluable at specified time points."|||g/L||Standard Deviation|Mean
2666162|NCT01526057|Secondary|Area Under the CD19+ B-cell Count Concentration-time Profile (AUC 0-T, B-cell)|The AUC 0-T, B-cell refers to the CD19+ B-cell count over time. It represents the total B-cells over time, from time 0 (the point of drug administration) to the last measured count at time T.|Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)|"mITT population. Overall Number of Participants Analyzed= participants evaluable for this outcome measure."|||cells*day/uL||Standard Deviation|Mean
2666163|NCT01526057|Secondary|Percentage of Participants With CD19+ B-cell Count Recovery|The percentage of participants with CD19+ B-cell counts which fell to <50% of Baseline value during treatment and which recovered to ≥50% of Baseline value at End of Treatment.|Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25|"mITT population. Overall Number of Participants Analyzed= participants evaluable for this outcome measure."|||Percentage of participants|||Number
2666164|NCT01526057|Secondary|Duration of B-cell Depletion (τB-cell) (Days)|The τB-cell is defined as the time interval over which the B-cell count was <0.3 cells/uL or the detection limit.|Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)|"mITT population. Overall Number of Participants Analyzed= participants evaluable for this outcome measure."|||days||Standard Deviation|Mean
2666165|NCT01526057|Secondary|Time to Minimum Post-Baseline CD19+ B-cell Count (Weeks)|The amount of time in weeks from baseline to the lowest observed CD19+ B-cell count.|Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)|"mITT population. Overall Number of Participants Analyzed= participants evaluable for this outcome measure."|||weeks||Standard Deviation|Mean
2666166|NCT01526057|Secondary|Minimum Post-Baseline CD19+ B-cell Count (/uL)|The lowest CD19+ B-cell count measured in a participant's blood post-baseline.|Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)|"mITT population. Overall Number of Participants Analyzed= participants evaluable for this outcome measure."|||cells/uL||Standard Deviation|Mean
2666167|NCT01526057|Secondary|CD19+ B-cell Count AUC From Time 0 to the Last Measurement at Time T (AUC 0-T,B-cell)|The AUC 0-T,B-cell refers to the concentration in serum of B-cells. It represents the total B-cells over time from time 0 (the point of drug administration) to the last measurement taken at time T.|Baseline and Weeks 2, 3, 5, 9, 13, 17, 21 and 25 (EOT)|"mITT population. Overall Number of Participants Analyzed= participants evaluable for this outcome measure."|||cells*day/mL||Standard Deviation|Mean
2666168|NCT01526057|Secondary|Rituximab AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUC 0-T)|The AUC 0-T refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) to the last measured concentration at time T.|Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion|PP population.|||ug*hr/mL||Standard Deviation|Mean
2666169|NCT01526057|Secondary|Rituximab AUC From Time 0 to 2 Weeks (AUC 0-2wk)|The AUC 0-2wk refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) to 2 weeks after drug administration.|Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion|PP population.|||ug*hr/mL||Standard Deviation|Mean
2666170|NCT01526057|Primary|AUC 0-inf of Rituximab|The AUC 0-inf refers to the concentration in serum of the drug over time. It represents the total drug exposure over time, from time 0 (the point of drug administration) extrapolated to infinity.|Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion|"PP population. Overall Number of Participants Analyzed= participants evaluable for this outcome measure."|||ug*hr/mL||Standard Deviation|Mean
2666171|NCT01526057|Primary|Maximum Serum Concentration (Cmax) of Rituximab|Cmax is the peak serum concentration of study drug (rituximab) after a dose has been administered.|Predose (Day 1) and 3, 4.25 (immediately before 1st infusion end), 72, 168, 335 (Day 15 within 1.5 hours before 2nd infusion), 337.5, 339.25 (Day 15 immediately before 2nd infusion end), 408, 504, 672, 1344, and 2016 hours after start of 1st infusion|Per protocol (PP) population: all participants who were randomized, received the full doses of the assigned study treatment, and had no major protocol violations that could impact the pharmacokinetic (PK) analysis. Exclusions from the PP population were based on a blinded data review by the Medical Monitor and Clinical Pharmacologist.|||micrograms per milliliter||Standard Deviation|Mean
2666172|NCT01525927|Secondary|Identify Additional Toxicity of Treatment|To identify additional toxicity of treatment|During therapy and up to 5 years following completion of treatment|No study intervention or data collected- Zero (0) participants analyzed||||||
2666173|NCT01525927|Secondary|Assessment of Quality of Life Outcomes|Serial evaluation of functional quality-of-life, including M. D. Anderson Dysphagia Inventory (MDADI) and Oropharyngeal swallowing efficiency (OPSE) measures of swallowing function, as well as formal sialometric measurement of parotid function.|Baseline, during therapy and up to two years following completion of radiation phase|No study intervention or data collected- Zero (0) participants analyzed||||||
2666174|NCT01525927|Secondary|Assess Distant Disease Control at 2 Years.|3.5 To assess distant disease control at 2 years.|At two years following completion of radiation phase|No study intervention or data collected- Zero (0) participants analyzed||||||
2666175|NCT01525927|Secondary|Assess Locoregional Disease Control at 2 Years|To assess locoregional disease control at 2 years|At two years following completion of radiation phase|No study intervention or data collected- Zero (0) participants analyzed||||||
2666176|NCT01525927|Secondary|Assess Overall Survival at 2 Years.|To assess overall survival at 2 years.|At two years following completion of radiation phase|No study intervention or data collected- Zero (0) participants analyzed||||||
2666177|NCT01525927|Secondary|Progression-free Survival at 2 Years|assess Progression-free survival at 2 years.|At two years following completion of radiation phase|No study intervention or data collected- Zero (0) participants analyzed||||||
2666178|NCT01525927|Secondary|To Define Objective Tumor Response Rates to Induction Chemotherapy and to Subsequent Radiation-based Treatment.|To define objective tumor response rates to induction chemotherapy and to subsequent radiation-based treatment, per RESIST version 1.1 criteria.|Three months following completion of radiation therapy phase.|||||||
2666179|NCT01525927|Primary|Response (CR+PR) Status at 3 Months Post-therapy|"The 3-month response rate will be estimated using standard methods for estimating proportions and their 95% one-sided confidence intervals (CIs). Comparison to the historical control data will be carried out using a chi-square test for comparing proportions (or a Fisher exact test if an expected cell frequency in the 2x2 table is less than 5).~Zero (0) participants analyzed"|3 months following completion of radiation phase|No study intervention or data collected.||||||
2666180|NCT01525875|Secondary|Central Retinal Thickness|Rate of disease progression observed through ophthalmologic examinations. (+) a decrease in this scores indicates improvement of the disease; (-) an increase in this scores indicates improvement of the disease.|2 years||||µm||Standard Error|Mean
2666181|NCT01525875|Secondary|VAS - Visual Acuity Score|Rate of disease progression observed through ophthalmologic examinations.(+) an increase in this score indicates improvement of the disease (-) a decrease in this score indicates worsening of the disease. VAS ranges from 10 to 200, with higher score indicating poorer visual acuity.|2 years||||units on a scale||Standard Error|Mean
2666182|NCT01525875|Secondary|LogMar|Rate of disease progression - Changes observed through ophthalmologic examinations. (+) a decrease in this score indicates improvement of the disease (-) an increase in this score indicates worsening of the disease. LogMAR: logarithm of the minimum angle of resolution. The LogMAR scale converts the geometric sequence of a traditional chart to a linear scale. It measures visual acuity loss: positive values indicate vision loss, while negative values denote normal or better visual acuity.|2 years||||LogMar||Standard Error|Mean
2666183|NCT01525875|Secondary|Number of Participants With a 1-point Decrease of Target Lesions|Changes in skin skin lesions observed through investigator evaluations and clinical photographs. The number of patients with a 1-point decrease of target lesions|up to 2 years||||Participants|||Count of Participants
2666184|NCT01525875|Primary|Von Kossa Staining Per Unit Area of Dermis|A blinded dermatopathologist graded skin biopsies on the density of Von Kossa staining, assessed changes in the amount of calcification of elastic fibers by assessing von Kossa staining per unit area of dermis|up to 2 years|Estimate: Estimated change from baseline and its standard error (SEM). After 1 year=M12-Baseline, After 2 year=M24-Baseline; during 2nd year =M24-M12.|||microns||Standard Error|Mean
2666185|NCT01525849|Secondary|Recovery Time|Mean time (days) after procedure for participants to return to normal activities|6-months|All treated participants with 6-month follow-up.|||days||Standard Deviation|Mean
2666186|NCT01525849|Secondary|Complication Rate|Number of participants experiencing 1 or more serious adverse events related to the device and/or procedure|Duration of study (minimum of 12 months)|All randomized participants|||Participants|||Count of Participants
2666187|NCT01525849|Secondary|Revision Rate|Number of participants requiring repeat sinus procedures|1-year|All treated participants with 1-year follow-up (or a revision surgery before 1-year follow-up if no 1-year follow-up).|||Participants|||Count of Participants
2666188|NCT01525849|Primary|Debridements|Number of postoperative debridements per participant|1-year|All treated participants|||debridements per participant||Standard Deviation|Mean
2666564|NCT01522456|Primary|Worst Postbaseline Tolerability (Erythema)|Worst postbaseline tolerability assessment for erythema.|Day 1 - Day 22|Safety population|||participants|||Number
2666189|NCT01525849|Primary|Sinus Symptom Improvement|Change from baseline in overall 20-item Sino-Nasal Outcome Test (SNOT-20) score. The SNOT-20 is a validated patient reported survey of 20 items related to sinonasal symptoms and severity assessed over the previous 2 weeks. Each item is scored from 0 (no problem) to 5 (problem as bad as it can be). The individual item scores are averaged to provide and overall score that ranges from 0 (best) to 5 (worst).|Baseline and 1-year|All treated participants with matched pair SNOT-20 data at baseline and 1-year.|||units on a scale||Standard Deviation|Mean
2666190|NCT01525745|Secondary|Survival|Progrsesion Free and Overall Survival|2 years|data not collected, therefore no analysis done||||||
2666191|NCT01525745|Secondary|Long Term Effects of Image-guided Radiosurgery/SBRT|Long term effects of image-guided radiosurgery/SBRT on the vertevral bone and spinal cord|2 years|data not collected, therefore no analysis done||||||
2666192|NCT01525745|Secondary|Quality of Life|Evaluate potential benefit of image-guided radiosurgery/SBRT on change in and overall quality of life as measured by FACT-G, BPI and EQ-5D|2 years|data not collected, therefore no analysis done||||||
2666193|NCT01525745|Secondary|Duration of Pain Response|Determine if image-guided radiosurgery/SBRT improves duration of pain as compared to conventional external beam radiotherapy|2 years|data not collected, therefore no analysis done||||||
2666194|NCT01525745|Primary|Pain Control as Measured by NPRS|Determine if image-guided radiosurgery/SBRT improves pain control as measured by NPRS as compared to conventional external beam radiotherapy|2 years|study was terminated by the local IRB due to slow accrual. 1 participant withdrew consent and 1 participant did not complete the assigned arm treatment per protocol and then removed from study. left with 4 participants and data were not collected for any participants therefore no analysis has been done.||||||
2666195|NCT01525667|Secondary|Change From Day 0 to Week 26 in the Visual Analog Scale (VAS) Pain Score.|Visual Analog Scale (VAS) Pain Score ranges from 0 mm (no pain) to 100 mm (worse possible pain)|Day 0 to Week 26||||mm||Standard Error|Least Squares Mean
2666196|NCT01525667|Secondary|Change From Day 0 to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift .|Change from Visit 2 (Day 0) to Week 26 in the Ratio of Injured to Contralateral Pelvic Shift as Measured by Gait Analysis|Day 0 to Week 26||||Ratio||Standard Error|Least Squares Mean
2666197|NCT01525667|Secondary|Change From Day 1 to Week 12 in Mean Fiber Diameter.|Change from Visit 3 (Day 1) to Week 12 in Mean Fiber Diameter as Measured by Muscle Biopsy.|Day 1 to Week 12||||microns||Standard Error|Least Squares Mean
2666198|NCT01525667|Secondary|Change From Day 0 to Week 26 in Muscle Volume.|Change from Visit 2 (Day 0) to Week 26 in Muscle Volume as Measured by MRI.|Day 0 to Week 26||||mm3||Standard Error|Least Squares Mean
2666199|NCT01525667|Primary|Change From Day 0 to Week 26 in the Maximal Voluntary Isometric Contraction (MVIC) Moment of the Injured Side to Assess Gluteus Medius Strength.|Change from Visit 2 (Day 0) to Week 26 in the maximal voluntary isometric contraction (MVIC) moment of the injured side as measured by isometric dynamometry to assess Gluteus Medius force strength.|Day 0 to Week 26||||Newtons||Standard Error|Least Squares Mean
2666200|NCT01525641|Secondary|Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA|Number of patients with onset or offset of wearing-off phenomena in patients with concomitant levodopa (L-DOPA). Wearing-off is when Parkinson's symptoms begin to reappear or become noticeably worse before it is time to take the next scheduled dose of medication.|Week 52|Patients in safety set and with concomitant L-DOPA|||participants|||Number
2666201|NCT01525641|Secondary|Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA|"Number of patients with onset or offset of on-off phenomenon in patients with concomitant levodopa (L-DOPA). On-off phenomenon is the unpredictable shift from mobility - on - to a sudden inability to move - off."|Week 52|Patients in safety set and with concomitant L-DOPA.|||participants|||Number
2666202|NCT01525641|Secondary|Change From Baseline in the Modified Hoehn & Yahr to Last Observation|Change from baseline at the last observation in the modified Hoehn and Yahr stage. Stages of the Parkinson's disease will be assessed on an 8-degree scale between stage 0 (no sign of the disease) and 5 (wheelchair bound or bedridden unless aided) in steps of 0, 1, 1.5, 2, 2.5, 3, 4 and 5. A reduction in the score over time represents an improvement.|Baseline and week 52|Efficacy set|||Units on a scale||Standard Deviation|Mean
2666203|NCT01525641|Secondary|Change From Baseline in Total Score of the UPDRS Part III to Last Observation|"Change from baseline at the last observation in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III total score.~UPDRS Part III (motor examination) measures the extent of physical impairment displayed by the patient. This evaluation consists of 14 separate components of patient's physical status.~The UPDRS part III score is the sum of the 14 individual components. The UPDRS Part III total score ranges from 0 to 108.A reduction in UPDRS part III score over time corresponds to an improvement in motor activities.~The following are the 14 separate components:1. Speech 2. Facial expression 3. Tremor at rest 4. Action or postural tremor of hands 5. Rigidity 6. Finger taps 7. Hand movements 8. Rapid alternating movements of hands 9. Leg agility 10. Arising from chair 11. Posture 12. Gait 13. Postural stability 14. Body bradykinesia and hypokinesia."|Baseline and week 52|Efficacy set|||units on a scale||Standard Deviation|Mean
2666204|NCT01525641|Secondary|Clinical Global Impression of Effect|Clinical global impression (CGI) of effect at the last observation, on a rating scale from very much improved to no effect.|Week 52|Efficacy set: included all patients in the “safety set” except those who had no available efficacy data and/or who did not suffer from Parkinsons Disease|||participants|||Number
2666205|NCT01525641|Primary|Percentage of Adverse Drug Reactions|Percentage of subjects with adverse drug reactions|From baseline up to week 52|Safety set|||percentage of participants|||Number
2666206|NCT01525628|Secondary|Number of Participants With Sustained Virological Response (SVR12)|Sustained virologic response (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) undetectable at 12 weeks after the end of treatment. SVR12 was analyzed in a descriptive manner using frequency of participants who achieved SVR12.|12 weeks post treatment|Treated set (TRT): This subject set includes all patients who were dispensed trial medication and were documented to have taken at least one dose of trial drug.|||Participants|||Number
2666251|NCT01525563|Secondary|Overall Patient Satisfaction|The overall patient satisfaction was recorded on a 5 point Clinical Global Impression of Severity scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat satisfied, 4 = satisfied, 5 = very satisfied).|6 months|Overall at the EOT, of 910 patients population the overall satisfaction was assessed|||participants|||Number
2666207|NCT01525628|Primary|AUC 0-12hr of Raltegravir|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 hours.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.||||||
2666208|NCT01525628|Primary|C12hr of Raltegravir|Concentration of an analyte in plasma at 12 hours.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.||||||
2666209|NCT01525628|Primary|Cmax of Raltegravir|Maximum concentration of an analyte in plasma.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.||||||
2666210|NCT01525628|Primary|AUC 0-24hr of Tenofovir|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.||||||
2666211|NCT01525628|Primary|C24hr of Tenofovir|Concentration of an analyte in plasma at 24 hours.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.||||||
2666212|NCT01525628|Primary|Cmax of Tenofovir|Maximum concentration of an analyte in plasma.|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9 and 17|PKS. Due to Boehringer Ingelheim’s decision not to pursue the development of this substance, the extent of the statistical analysis was limited to selected endpoints. No further analysis is planned for the endpoints which were not related to patient efficacy or safety.||||||
2666213|NCT01525628|Primary|AUC 0-infinity of 1-OH-Midazolam (1-hydroxy-midazolam)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2666214|NCT01525628|Primary|Cmax of 1-OH-Midazolam (1-hydroxy-midazolam)|Maximum concentration of an analyte in plasma|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2666215|NCT01525628|Primary|AUC 0-infinity of Midazolam|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2666216|NCT01525628|Primary|Cmax of Midazolam|Maximum concentration of an analyte in plasma|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2666217|NCT01525628|Primary|AUC 0-infinity of Tolbutamide|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2666218|NCT01525628|Primary|Cmax of Tolbutamide|Maximum concentration of an analyte in plasma|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2666219|NCT01525628|Primary|AUC 0-infinity of Caffeine|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|5 min before and 1 hour (h), 2h, 3h, 4h, 5h, 6h, 8h, 10h, 11:55h, 15h, 23:55h, 26h, 28h, 29:55h, 32h after first drug administration on day 1 also 5 min before, 1h, 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after drug on days 9, 17 and 66.|PKS. This endpoint was not planned to be analysed for groups C, D and E|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2667292|NCT01516879|Primary|Percent Change From Baseline in LDL-C at Week 52|Cholesterol was measured by means of ultracentrifugation.|Baseline and Week 52|Full Analysis Set (all randomized subjects who received at least 1 dose of study drug).|||percent change||Standard Error|Least Squares Mean
2666221|NCT01525628|Primary|AUC 0-6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2666222|NCT01525628|Primary|C6hr of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)|Concentration of an analyte in plasma at 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2666223|NCT01525628|Primary|Cmax of Deleobuvir Metabolite CD 6168 ag (Acylglucuronide)|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2666224|NCT01525628|Primary|AUC 0-6hr of Deleobuvir Reduction Metabolite CD 6168|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2666225|NCT01525628|Primary|C6hr of Deleobuvir Reduction Metabolite CD 6168|Concentration of an analyte in plasma at 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2666226|NCT01525628|Primary|Cmax of Deleobuvir Reduction Metabolite CD 6168|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2666227|NCT01525628|Primary|AUC 0-6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2666228|NCT01525628|Primary|C6hr of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)|Concentration of an analyte in plasma at 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2666229|NCT01525628|Primary|Cmax of Deleobuvir Metabolite Acyl-glucuronide (BI 208333)|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2666230|NCT01525628|Primary|AUC 0-6hr of Deleobuvir (BI 207127)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2666231|NCT01525628|Primary|C6hr of Deleobuvir (BI 207127)|Concentration of an analyte in plasma at 6 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2666232|NCT01525628|Primary|Cmax of Deleobuvir (BI 207127)|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2666233|NCT01525628|Primary|Area Under the Concentration-time Curve (AUC) of Faldaprevir (BI 201335) From 0 to 24 Hours|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2666234|NCT01525628|Primary|C24hr of Faldaprevir (BI 201335)|Concentration of an analyte in plasma at 24 hours|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2666235|NCT01525628|Primary|Cmax of Faldaprevir (BI 201335)|Maximum concentration of an analyte in plasma|PK plasma samples were taken at: 5 minutes before drug administration and 1 hour (h), 2h, 3h, 4h, 5h, 5:55h, 8h, 10h, 11:55h, 15h, 23:55h after first drug administration on days 9, 17 and 66.|The pharmacokinetic set (PKS): included all patients in the treated set who provided at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK. This endpoint was not planned to be analysed for groups C, D and E.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2666236|NCT01525615|Secondary|Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 12 Weeks|Secondary endpoint was adjusted mean 1-hour, post-dose Forced Expiratory Volume in one second (FEV1) observed after 12 weeks of treatment|12 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.|||liters||Standard Error|Least Squares Mean
2666237|NCT01525615|Secondary|Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 6 Weeks|Secondary endpoint was adjusted mean 1-hour, post-dose Forced Expiratory Volume in one second (FEV1) observed after 6 weeks of treatment|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.|||liters||Standard Error|Least Squares Mean
2666238|NCT01525615|Secondary|Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) on Day 1|Secondary endpoint was adjusted mean 1-hour, post-dose Forced Expiratory Volume in one second (FEV1) observed on day 1|1 day|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.|||liters||Standard Error|Least Squares Mean
2666239|NCT01525615|Secondary|Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 12|"Secondary endpoint was the slope of the intensity of breathing discomfort during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 12 weeks of treatment.~The intensity of breathing discomfort was rated on the Borg Scale with categories from 0 (nothing at all) to 10 (maximal). The slope of the intensity of breathing discomfort was defined as the Borg scale value of breathing discomfort at the end of exercise minus the Borg scale value of breathing discomfort at pre-exercise divided by the endurance time. A decrease in slope indicates favorable results."|12 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.|||units / seconds||Standard Error|Least Squares Mean
2666240|NCT01525615|Secondary|Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 6|"Secondary endpoint was the slope of the intensity of breathing discomfort during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment.~The intensity of breathing discomfort was rated on the Borg Scale with categories from 0 (nothing at all) to 10 (maximal). The slope of the intensity of breathing discomfort was defined as the Borg scale value of breathing discomfort at the end of exercise minus the Borg scale value of breathing discomfort at pre-exercise divided by the endurance time. A decrease in slope indicates favorable results."|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.|||units / seconds||Standard Error|Least Squares Mean
2666241|NCT01525615|Secondary|Adjusted Mean Slope of the Intensity of Breathing Discomfort on Day 1|"Secondary endpoint was the slope of the intensity of breathing discomfort during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 1 day of treatment.~The intensity of breathing discomfort was rated on the Borg Scale with categories from 0 (nothing at all) to 10 (maximal). The slope of the intensity of breathing discomfort was defined as the Borg scale value of breathing discomfort at the end of exercise minus the Borg scale value of breathing discomfort at pre-exercise divided by the endurance time. A decrease in slope indicates slowing down in decline in breathing, i.e., favorable results."|1 day|Visit 4 Set. All randomized patients dispensed medication, were documented to have taken any dose of study medication, and had evaluable measurements of endurance time at Baseline (Visit 3) and at Visit 4 (Day 1) during CWRCE. Patients were assigned to the Visit 4 set after implementation of data handling rules that set measurements to missing.|||units / seconds||Standard Error|Least Squares Mean
2667293|NCT01516749|Secondary|Change in C-reactive Protein|Change assessed from baseline to end of treatment phase.|Baseline, 8 weeks|Patients who completed 8 weeks of therapy|||mg/L||95% Confidence Interval|Mean
2666242|NCT01525615|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks|Secondary endpoint was pre-exercise inspiratory capacity (IC) during constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap) after 6 weeks of treatment.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.|||liters||Standard Error|Least Squares Mean
2666243|NCT01525615|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 1 Day|Secondary endpoint was pre-exercise inspiratory capacity (IC) during constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap) on Day 1.|1 day|Visit 4 Set. All randomized patients dispensed medication, were documented to have taken any dose of study medication, and had evaluable measurements of endurance time at Baseline (Visit 3) and at Visit 4 (Day 1) during CWRCE. Patients were assigned to the Visit 4 set after implementation of data handling rules that set measurements to missing.|||liters||Standard Error|Least Squares Mean
2666244|NCT01525615|Secondary|Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 6 Weeks Treatment|Secondary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment.The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.|6 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.|||seconds||Standard Error|Least Squares Mean
2666245|NCT01525615|Secondary|Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) on Day 1|Secondary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity on Day 1. Analysis of covariance model on log10 transformation data. Adjusted means are back transformed to report in original units. Standard errors (SEs) are calculated using the delta method.|1 day|Visit 4 Set. All randomized patients dispensed medication, were documented to have taken any dose of study medication, and had evaluable measurements of endurance time at Baseline (Visit 3) and at Visit 4 (Day 1) during CWRCE. Patients were assigned to the Visit 4 set after implementation of data handling rules that set measurements to missing.|||seconds||Standard Error|Least Squares Mean
2666246|NCT01525615|Secondary|Adjusted Mean Inspiratory Capacity at Pre-exercise After 12 Weeks|Secondary endpoint was pre-exercise inspiratory capacity (IC) before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap) after 12 weeks of treatment.|12 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.|||liters||Standard Error|Least Squares Mean
2666247|NCT01525615|Secondary|Adjusted Mean Endurance Time During Endurance Shuttle Walk Test (ESWT) After 12 Weeks|Key secondary endpoint was endurance time during endurance shuttle walk test to symptom limitation at 85% of predicted maximum oxygen consumption (VO2) peak after 12 weeks of treatment. The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.|12 weeks|Endurance shuttle walk test (ESWT) substudy set - This patient set included all patients in the Treated Set who had given informed consent for participating in the ESWT substudy and had a baseline and at least one post-baseline measurement during ESWT before or at Week 12 for the key secondary endpoint.|||seconds||Standard Error|Least Squares Mean
2666248|NCT01525615|Primary|Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks|Primary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 12 weeks of treatment. The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.|12 weeks|Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline and at least one post-baseline measurement before or at Week 12 for the primary endpoint.|||seconds||Standard Error|Least Squares Mean
2666249|NCT01525563|Secondary|Overall Clinical Response|Overall response (on a 7 point Clinical Global Impression of Severity scale, where 1 = Normal, not at all ill, 2 = Borderline ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Most extremely ill) at the EOT by assessing percentages of patients in each category at the EOT.|6 months|Overall response (on a 7 point Clinical Global Impression of Severity scale, where 1 = Normal, not at all ill, 2 = Borderline ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Most extremely ill) at the EOT by assessing percentages of patients in each category at the EOT.|||participants|||Number
2666250|NCT01525563|Secondary|Evolution of Duration of Menstrual Bleeding From Baseline to End of Treatment|To observe the evolution of duration of menstrual bleeding from baseline to end of treatment by assessing mean duration of menstrual bleeding (in days) at baseline and at the end of treatment.|6 months|To observe the evolution of duration of menstrual bleeding from baseline (all enrolled) to end of treatment by assessing mean duration of menstrual bleeding (in days) at baseline and at the end of treatment (EOT).|||Days||Standard Deviation|Mean
2667382|NCT01515696|Primary|Time to Complete Meconium Evacuation in Days|Time to complete meconium evacuation in days of life until the complete meconium evacuation from birth up to 40 days of life|days of life until until the complete meconium evacuation from birth up to 40 days of life|per protocol|||days of life||Full Range|Median
2666254|NCT01525563|Secondary|Change in Cycle Duration (in Days) From Baseline to End of Treatment (EOT)|The evolution of cycle duration from baseline to EOT was assessed by mean cycle duration (in days) at baseline, separately in polymenorrhea and oligomenorrhea groups, and at the EOT. The patients were included in polymenorrhea group in case the cycle duration at baseline was less than 21 days and in oligomenorrhea group in case the cycle duration at baseline was greater than 35 days.|6 months|All patients were assessed for overall reduction in cycle duration (910).|||Days||Standard Deviation|Mean
2666255|NCT01525563|Primary|Percentage of Patients Reporting a Regular Cycle|Regular cycle is defined as cycle duration between 21 to 35 days, inclusive at the end of treatment period.|6 months|Intent-to-Treat Population|||percentage of participants||95% Confidence Interval|Number
2666256|NCT01525550|Secondary|Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)|ECOG-PS performance status is used to assess how the disease affects the daily living abilities of the participant. It was measured on 6-point scale ranging from 0-5, where 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work; 2= ambulatory for more than 50 percent of waking hours and capable of all self-care but unable to carry out any work activities; 3= capable of limited self-care, confined to bed or chair >50 percent of waking hours; 4= completely disabled, not capable of any self-care, totally confined to bed or chair; 5= dead. A higher score indicated greater functional impairment. Only those ECOG-PS categories, in which at least one participant had data at any indicated time point were reported in this outcome measure. Not reported (NR) category included participants with unavailable ECOG performance status.|Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)|Safety analysis set included all participants who received at least 1 dose of study medication. Here, “0 participants” in the “number analyzed” field signifies none of the participants were evaluable in the given group at this time point, hence data was not reported.|||participants|||Number
2666257|NCT01525550|Secondary|Number of Participants With Change From Baseline in Body Weight|Participants with increase of >=5 percent and decrease of >=5 percent from baseline in body weight were reported in this outcome measure.|Baseline up to 1939 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2666258|NCT01525550|Secondary|Number of Participants With Change From Baseline in Physical Examinations Findings|Physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, extremities, thyroid and others.|Baseline up to 1939 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2666259|NCT01525550|Secondary|Number of Participants With Increase From Baseline in Corrected QT Interval (QTc)||Baseline up to 1939 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2666260|NCT01525550|Secondary|Number of Participants With Change From Baseline in Vital Signs Abnormalities|Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, body temperature and heart rate.|Baseline up to 1939 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2666261|NCT01525550|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities|Following parameters were analyzed for laboratory examination: hematology (hemoglobin, red blood cell count, platelet count, white blood cell count, total neutrophils, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine); electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate); urinalysis (urine protein), miscellaneous (pregnancy test, Chromogranin A). Clinically significant laboratory abnormalities were identified by the Investigator.|Baseline up to 1939 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2666262|NCT01525550|Secondary|Number of Participants With Adverse Events (AEs) According to Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death.|Baseline up to 1939 days|"Safety analysis set included all participants who received at least 1 dose of study medication. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2666263|NCT01525550|Secondary|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 1939 days that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.|Baseline up to 1939 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2666264|NCT01525550|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 1939 days that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to 1939 days|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2666265|NCT01525550|Secondary|Half Maximal Effective Concentration (EC50) of Sunitinib|Concentration of sunitinib in plasma at which 50 percent of the maximum effect was observed.|Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)|Due to insufficient data, there was substantial uncertainty associated with the parameter estimates; therefore, the population PK/PD analyses was not completed. Instead, the exposure response analyses with respect to different safety and efficacy endpoints were carried out and reported.||||||
2666266|NCT01525550|Secondary|Oral Clearance (CL/F) of Sunitinib and Its Metabolite SU012662|Clearance is a quantitative measure of the rate at which a drug substance is removed from the body.|Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)|Due to insufficient data, there was substantial uncertainty associated with the parameter estimates; therefore, the population PK/PD analyses was not completed. Instead, the exposure response analyses with respect to different safety and efficacy endpoints were carried out and reported.||||||
2666267|NCT01525550|Secondary|Area Under the Curve (AUC24) of Sunitinib and Its Metabolite SU012662|Area under the plasma concentration-time profile from time zero (pre-dose) to 24 hours post-dose. SU012662 is the metabolite of sunitinib.|Pre-dose (0 hour) and at multiple time points (up to 24 hours) post dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)|Due to insufficient data, there was substantial uncertainty associated with the parameter estimates; therefore, the population PK/PD analyses was not completed. Instead, the exposure response analyses with respect to different safety and efficacy endpoints were carried out and reported.||||||
2666268|NCT01525550|Secondary|Dose-Corrected Trough Plasma Concentration of Sunitinib and Its Metabolite SU012662|Dose-corrected plasma trough concentration is calculated as: trough plasma concentration*(intended dose divided by actual dose). Intended dose was defined as the starting dose in the study and actual dose was defined as the last dose which the participant had received. SU012662 is the metabolite of sunitinib.|Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5|PK population included all participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline value for each parameters.|||ng/mL||Standard Deviation|Mean
2666269|NCT01525550|Secondary|Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and Its Metabolite SU012662|Ctrough is the minimum observed plasma concentration of drug. SU012662 is the metabolite of sunitinib.|Pre-dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5|Pharmacokinetic (PK) population included all participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline value for each parameters.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2666270|NCT01525550|Secondary|Plasma Concentration of Soluble Protein Biomarker (sKIT)||Pre-dose on Day 1 and 15 of Cycle 1, Day 1 of Cycle 2, 3 and every 2 cycles thereafter (Cycle 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, 43), End of Treatment (up to maximum duration of 1226 days)|sKIT analysis set: enrolled participants who received at least 1 dose of study drug, had at least 1 biomarker parameter from corresponding assay sample with both baseline and post-treatment assessment. Here, “0 participants” in “number analyzed” field=none of the participants were evaluable in given group at this time point, hence data not reported|||picogram per milliliter (pcg/mL)||Standard Deviation|Mean
2666271|NCT01525550|Secondary|Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)|EORTC QLQ-GI-NET 21 was a 21-item questionnaire. These 21 questions assesses endocrine symptoms, gastrointestinal (G.I.) symptoms, treatment related symptoms, social functioning, disease related worries, muscle/bone pain, sexual function, information/communication function and body image. Each item was answered on a 4-point scale: 1 =not at all, 2 =a little, 3 =quite a bit, 4 =very much; where higher scores indicated more severe symptoms/problems. Scores averaged, transformed to 0-100 scale; higher score=more severe symptoms.|Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not. Here, “0 participants” in the “number analyzed” field signifies none of the participants were evaluable in the given group at this time point, hence data was not reported.|||units on a scale||Standard Deviation|Mean
2666272|NCT01525550|Secondary|Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)|EORTC QLQ-C30 is a cancer-specific instrument with 30 questions to assess the participant quality of life. First 28 questions used for evaluating 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, pain) and other single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Each question was assessed on 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much); high score represented high level of symptomatology/problem. Last 2 questions used for evaluating global health status (GHS)/quality of life. Each question was assessed on 7-point scale (1=very poor to 7=excellent). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning.|Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not. Here, “0 participants” in the “number analyzed” field signifies none of the participants were evaluable in the given group at this time point, hence data was not reported.|||units on a scale||Standard Deviation|Mean
2666273|NCT01525550|Secondary|Percentage of Participants With Chromogranin A (CgA) Response|CgA response in participants was defined as having confirmed CgA CR or CgA PR, relative to the population with an elevated baseline CgA value in the blood. CgA CR was defined as decrease from a high baseline value of CgA in the blood to one that fell within the normal range. CgA PR was defined as a decrease of greater than or equal to 50 percent from a high baseline value of CgA. Normal baseline value of CgA in blood was 39.0 ng/mL. Confirmed responses were those that persisted for at least 4 weeks after initial documentation of response. Blood levels of CgA were assessed and percentage of participants with CgA response were reported.|Baseline until CgA response or death due to any cause (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.|||percentage of participants||95% Confidence Interval|Number
2666274|NCT01525550|Secondary|Time to Tumor Response (TTR): Independent Radiological Review (IRR) Assessment|IRR assessed TTR was defined as the time (in months) from date of enrollment in study until first documentation of objective tumor response (CR or PR) that was subsequently confirmed. TTR was calculated as (first response date minus the date of enrollment plus 1) divided by 30.4. According to Choi criteria, CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as a decrease of >=10 percent in tumor size or a decrease in tumor density (HU) of 15 percent or more on CT with no new lesions and no obvious progression of non-measurable disease.|Baseline until first documented objective tumor response (up to 1226 days)|Analysis was performed on only those participants who had objective response as per IRR assessment.|||months||Full Range|Median
2666275|NCT01525550|Secondary|Duration of Response (DOR): Independent Radiological Review (IRR) Assessment|IRR assessed DOR was defined as the time (in months) from the date of first documented objective tumor response (CR or PR) that was subsequently confirmed to the first documented objective tumor progression or death due to any cause, whichever occurred first. According to Choi criteria, CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as a decrease of >=10 percent in tumor size or a decrease in tumor density (HU) of 15 percent or more on CT with no new lesions and no obvious progression of non-measurable disease.|Baseline until disease progression or death due to any cause (up to 1226 days)|Analysis was performed on only those participants who had objective response as per IRR assessment.|||months||95% Confidence Interval|Median
2666276|NCT01525550|Secondary|Percentage of Participants With Objective Response (OR): Independent Radiological Review (IRR) Assessment|IRR assessed OR in participants was defined as having a CR or PR according to Choi criteria and sustained for at least 4 weeks. According to Choi criteria, CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as a decrease of >=10 percent in tumor size or a decrease in tumor density (HU) of 15 percent or more on Computed tomography (CT) with no new lesions and no obvious progression of non-measurable disease. Percentage of participants with objective response were reported in this outcome measure.|Baseline until disease progression or death due to any cause (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.|||percentage of participants||95% Confidence Interval|Number
2666277|NCT01525550|Secondary|Time to Tumor Response (TTR): Investigator Assessment|Investigator assessed TTR was defined as the time (in months) from date of enrollment in study until date of first documentation of objective tumor response (CR or PR) that was subsequently confirmed. TTR was calculated as (first response date minus the date of enrollment plus 1) divided by 30.4. As per RECIST 1.0, CR was defined as disappearance of all target and non-target lesions and PR was defined as >=30 percent decrease in the sum of the LD of the target lesions taking as a reference the baseline sum LD.|Baseline until first documented objective tumor response (up to 1226 days)|Analysis was performed on only those participants who had objective response as per investigator assessment.|||months||Full Range|Median
2666278|NCT01525550|Secondary|Duration of Response (DOR): Investigator Assessment|Investigator assessed DOR was defined as the time (in months) from the date of first documented objective tumor response (CR or PR), that was subsequently confirmed, to the first documented objective tumor progression or death due to any cause, whichever occurred first. According to RECIST 1.0, CR was defined as disappearance of all target and non-target lesions. PR was defined as >=30 percent decrease in the sum of the LD of the target lesions taking as a reference the baseline sum LD. Progression as per RECIST version 1.0 was defined as >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.|Baseline until disease progression or death due to any cause (up to 1226 days)|Analysis was performed on only those participants who had objective response as per investigator assessment.|||months||95% Confidence Interval|Median
2666279|NCT01525550|Secondary|Percentage of Participants With Objective Response (OR): Investigator Assessment|Investigator assessed OR in participants was defined as having a complete response (CR) or partial response (PR) according to RECIST 1.0 and sustained for at least 4 weeks. CR was defined as disappearance of all target and non-target lesions. PR was defined as >=30 percent decrease in the sum of the LD of the target lesions taking as a reference the baseline sum LD. Percentage of participants with investigator assessed OR were reported.|Baseline until disease progression or death due to any cause (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.|||percentage of participants||95% Confidence Interval|Number
2666280|NCT01525550|Secondary|Overall Survival (OS)|OS was defined as the time (in months) from date of enrollment in study to the date of death due to any cause. If death was not observed, the participant was censored at the earliest of the last date the participant was known to be alive or the end of study. The analysis was performed by Kaplan-Meier method.|Baseline until death or end of study (up to 1939 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.|||Months||95% Confidence Interval|Median
2666281|NCT01525550|Secondary|Time to Tumor Progression (TTP): Investigator Assessment|Investigator assessed TTP was defined as the time (in months) from the date of enrollment in study until the date of first documentation of objective tumor progression. TTP calculated as (first event date minus date of enrollment plus 1)/30.4. Progression as per RECIST 1.0 was defined as >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. The analysis was performed by Kaplan-Meier method.|Baseline until first documented tumor progression (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.|||months||95% Confidence Interval|Median
2666313|NCT01525238|Primary|Mean Plasma Half-life (T-HALF) of Dapagliflozin|Plasma half-life (T-Half) for Dapagliflozin was derived from plasma concentrations versus time data. Means are reported in hours.|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||hours||Standard Deviation|Mean
2667439|NCT01515176|Secondary|Complete Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions|Up to 28 weeks||||patients with complete response||95% Confidence Interval|Number
2666282|NCT01525550|Secondary|Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment|IRR assessed PFS was defined as the time (in months) from the date of enrollment in study until the date of first documented objective tumor progression or death (due to any cause), whichever occurs first. PFS calculated as (first event date minus date of enrollment plus 1)/30.4. If progression or death was not observed, the participant was censored at the date of the participant's last progression-free tumor assessment prior to the study cut-off date. Progression as per RECIST 1.0 criteria was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. The analysis was performed by Kaplan-Meier method.|Baseline until disease progression or death due to any cause (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.|||months||95% Confidence Interval|Median
2666283|NCT01525550|Primary|Progression-Free Survival (PFS): Investigator Assessment|Investigator assessed PFS was defined as the time (in months) from the date of enrollment in study to the date of first documented objective tumor progression or death (due to any cause), whichever occurs first. PFS calculated as (first event date minus date of enrollment plus 1)/30.4. If progression or death was not observed, the participant was censored at the date of the participant's last progression-free tumor assessment prior to the study cut-off date. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria was defined as: greater than or equal to (>=) 20 percent increase in sum of longest diameter (LD) of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. The analysis was performed by Kaplan-Meier method.|Baseline until disease progression or death due to any cause (up to 1226 days)|FAS included all participants who were enrolled into the study regardless of whether participants received study drug or not.|||months||95% Confidence Interval|Median
2666284|NCT01525420|Secondary|7-day and 24-hour Point Prevalence Quit Rates|7-day and 24-hour point prevalence quit rates|6-month|||||||
2666285|NCT01525420|Primary|Number of Participants Who Stopped Smoking by 6 Month Post Treatment|30-Day point prevalence abstinence at 6 months post treatment|6 months||||participants|||Number
2666286|NCT01525407|Secondary|Recurrent or Progressive Malignancy|Cumulative incidence rate of recurrent or progressive malignancy with death as a competing risk, assessed at 3 years in the patients/recipients.|Up to 3 years||||probability||95% Confidence Interval|Number
2666287|NCT01525407|Secondary|Proportion of Patients Requiring Secondary Systemic Immunosuppressive Therapy||First 100 days after transplant||||Participants|||Count of Participants
2666288|NCT01525407|Secondary|Proportion of Donors Who Have to Discontinue Atorvastatin Because of Toxicity||Until completion of stem cell collection (on average 14 days)||||Participants|||Count of Participants
2666289|NCT01525407|Secondary|Overall Survival|Determined and presented as Kaplan-Meier estimates, assessed at 1 year in the patients/recipients.|1 year after transplant||||survival probability||95% Confidence Interval|Number
2666290|NCT01525407|Secondary|Non-relapse Mortality|Cumulative incidence rate of non-relapse mortalities, assessed at one year in the patients/recipients.|At 1 year after HCT||||probability||95% Confidence Interval|Number
2666291|NCT01525407|Secondary|Non-relapse Mortality|Cumulative incidence rate of non-relapse mortalities, assessed at day 100 in the patients/recipients.|At day 100||||probability||95% Confidence Interval|Number
2666292|NCT01525407|Secondary|Grades II-IV Acute GVHD|Cumulative incidence rate of grades II-IV acute GVHD with death as a competing risk, assessed at 100 days in the patients/recipients.|First 100 days after transplant||||probability||95% Confidence Interval|Number
2666293|NCT01525407|Secondary|Disease-free Survival|Evaluated as Kaplan-Meier estimate in the patients/recipients.|1 year after transplant||||disease free survival probability||95% Confidence Interval|Number
2666294|NCT01525407|Secondary|Chronic Extensive GVHD|Cumulative incidence rate of chronic extensive GVHD with death as a competing risk, assessed at 2 years in the patients/recipients.|2 years post transplant||||probability||95% Confidence Interval|Number
2666295|NCT01525407|Primary|Grade 3-4 Acute GVHD|Cumulative incidence rate of grade 3-4 acute GVHD with death as a completing risk, assessed at day 100 in the patients/recipients.|First 100 days after transplant||||probability||95% Confidence Interval|Number
2666296|NCT01525329|Secondary|Actinic Keratosis (AK) Clearance|Rate of AK clearance (Analyzed by linear mixed-effect model)|AK counts, over a 12-month period||||CR (% reduction)||95% Confidence Interval|Mean
2666297|NCT01525329|Primary|Accumulation of Porphyrin (PpIX)|"The primary endpoint of this study will be the accumulation of PpIX at 3 h after MAL application (measured noninvasively, in each treated region).~(Region refers to the half-face or half-scalp area treated with PDT monotherapy, or the contralateral area treated with the 5-FU/PDT combination regimen)."|Day 7 of the study||||Change in PpIX signal (arbitrary units)||95% Confidence Interval|Mean
2666298|NCT01525238|Secondary|Number of Participants With Marked Urinalysis Abnormalities|LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Blood, urine (Qualitative): >=2 (If Pre-Rx >= 1, >=2*Pre-Rx). Glucose, urine (Qualitative): >=1, (If Pre-Rx >=1, >=2*Pre-Rx). Protein, urine (Qualitative): >=2 (If Pre-Rx >=1, >=2*Pre-Rx). Red Blood Cells (RBC), urine (RBC per High Power Field (hpf)): >=2 (If Pre-Rx>=2, >=4). White Blood Cells (WBC), urine (hpf): >=2 (If Pre-Rx>=2, >=4).|Day 1 (Pre-dose) to Day 3|All treated participants with evaluable lab results|||participants|||Number
2666299|NCT01525238|Secondary|Number of Participants With Marked Abnormalities in Other Chemistry Testing|LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Glucose, fasting serum (mmol/L): <0.8*LLN, >1.3*ULN (if Pre-Rx<LLN: <0.8*Pre-Rx, >ULN. If Pre-Rx>ULN: >2.0*Pre-Rx, <LLN). Protein (grams per deciliter: g/L): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.1*Pre-Rx, <LLN). Albumin (g/L): <0.9*LLN (if Pre-Rx<LLN: <0.9*Pre-Rx). Uric Acid (mmol/L): >1.2*ULN (if Pre-Rx>ULN: >1.25*Pre-Rx). Lactate Dehydrogenase (U/L): >1.25*ULN (if Pre-Rx>ULN: >1.5*Pre-Rx)|Day 1 (Pre-dose) to Day 3|All treated participants|||participants|||Number
2670394|NCT01486966|Secondary|Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment||Week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.|||percentage (%) of subjects|||Number
2666300|NCT01525238|Secondary|Number of Participants With Marked Serum Chemistry Abnormalities|LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose. Lab values that met the following criteria were marked as abnormalities: Alkaline Phosphatase (units per liter: U/L), Aspartate Aminotransferase (U/L), Alanine Aminotransferase (U/L): >1.25*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx). Bilirubin (milligrams per deciliter: mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.25*Pre-Rx). Blood Urea Nitrogen (mg/dL): >1.1*ULN (if Pre-Rx>ULN, use >1.2*Pre-Rx). Creatinine (micromoles per Liter (umol/L)): >1.5*ULN if Pre-Rx missing or <= ULN, >1.33*Pre-Rx if PreRx > ULN. Sodium (mmol/L): >1.05*ULN, 1.05*Pre-Rx if Pre-Rx>ULN: <0.95*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.05*Pre-Rx, <LLN). Potassium(mmol/L), Chloride (mmol/L), Calcium(mmol/L): <0.9*LLN, >1.1*ULN (if Pre-Rx<LLN: <0.9*Pre-Rx, >ULN. If Pre-Rx>ULN: >1.1*Pre-Rx, <LLN). Phosphorus (mg/dL): <0.85*LLN, >1.25*ULN (if Pre-Rx<LLN, <0.85*Pre-Rx, >ULN. if Pre-Rx>ULN: >1.25*Pre-Rx, <LLN).|Day 1 (Pre-dose) to Day 3|All treated participants|||participants|||Number
2666301|NCT01525238|Secondary|Number of Participants With Marked Hematology Laboratory Abnormalities|LLN=Lower Limit of Normal, ULN=Upper Limit of Normal, Pre-Rx=Value before first dose (Day -1). Lab values that met the following criteria were marked as abnormalities: Hemoglobin (grams per deciliter:g/dL): <0.85*Pre-Rx. Hematocrit (%): <0.85*Pre-Rx. Platelet Count (x10^9 cells per liter:c/L): <0.85*LLN or >1.5*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx). Leukocytes (x10^3 cells per microliter: c/uL): <0.9*LLN, >1.2*ULN (if Pre-Rx<LLN, use <0.85*Pre-Rx or >ULN, if Pre- Rx>ULN, use >1.15*Pre-Rx or <LLN). Neutrophils (Absolute) (x10^3 c/uL): <=1.5. Lymphocytes (Absolute) (x10^3 c/uL): <0.75 or >7.5. Monocytes (Absolute) (x10^3 c/uL): >2.000. Basophils (x10^3 c/uL): >0.4. Eosinophils (Absolute) (x10^3 c/uL): >0.75. Blasts (Absolute) (x10^9 c/L) > 0.|Day 1 (Pre-dose) to Day 3|All treated participants|||participants|||Number
2666302|NCT01525238|Secondary|Number of Participants With Vital Sign Abnormalities, Electrocardiogram (ECG) Abnormalities, or Physical Examination Abnormalities Following Study Drug Administration.|Participants were followed from dosing on Day 1 until study discharge on Day 3. The number of participants with investigator-assessed clinically-important abnormalities in vital sign measurements, ECGs or physical examinations was reported.|Day 1 to Day 3|All treated participants|||participants|||Number
2666303|NCT01525238|Secondary|Mean Total Amount of Glucose Excreted in Urine Over 24 Hours|The total amount of glucose excreted in urine was measured for 24 hours following administration of Dapagliflozin. Means are reported in grams.|Time of dose to 24 hours post-dose, Day 1 to Day 2|All treated participants with evaluable PD profiles|||grams||Standard Deviation|Mean
2666304|NCT01525238|Secondary|Mean Change in Fasting Plasma Glucose From Baseline Until Day 2|Plasma glucose concentrations were evaluated in all treated subjects at Day 1 pre-dose and at Day 2 after fasting for 8 hours. Mean change from baseline to Day 2 is reported in milligrams per deciliter (mg/dL).|Day 1 (Pre-dose) to Day 2|All treated participants with evaluable PD profiles|||mg/dL||Standard Deviation|Mean
2666305|NCT01525238|Secondary|Mean Fasting Plasma Glucose Concentrations at Pre-dose on Day 1 and on Day 2 After an 8-hr Fasting|Plasma glucose concentrations were evaluated in all treated subjects at Day 1 pre-dose and at Day 2 after fasting for 8 hours. Means are reported in milligrams per deciliter (mg/dL).|Day 1 (Pre-dose) to Day 2|All treated participants with evaluable pharmacodynamic (PD) profiles|||mg/dL||Standard Deviation|Mean
2666306|NCT01525238|Secondary|Mean Plasma Half-life (T-HALF) of Dapagliflozin 3-O-Glucuronide|Plasma half-life (T-Half) for Dapagliflozin was derived from plasma concentration versus time data. Means are reported in hours.|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||hours||Standard Deviation|Mean
2666307|NCT01525238|Secondary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin 3-O-Glucuronide|Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of Dapagliflozin 3-O-Glucuronide over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2666308|NCT01525238|Secondary|Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin 3-O-Glucuronide|Area under the plasma concentration-time curve from time zero extrapolated to infinite time was derived from concentration versus time data. Geometric means are reported in nanogram hours per milliliter (ng*hr/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2666309|NCT01525238|Secondary|Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin 3-O-Glucuronide|Time of maximum observed plasma concentration (Tmax) for Dapagliflozin 3-O-Glucuronide was derived from plasma concentrations versus time data. Medians were reported in hours (h).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||hours||Full Range|Median
2666310|NCT01525238|Secondary|Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin 3-O-Glucuronide|Maximum observed plasma concentration (Cmax) was measured by plasma concentration of Dapagliflozin 3-O-Glucuronide over time. The geometric means are reported in nanograms per milliliter (ng/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2666311|NCT01525238|Primary|Geometric Mean of Apparent Volume of Distribution at Terminal Phase After Extravascular Administration (Vz/F) of Dapagliflozin|Geometric mean of apparent volume of distribution at terminal phase after extravascular administration of Dapagliflozin was derived from plasma concentration versus time data. Geometric means are reported in Liters (L)|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||Liters||Geometric Coefficient of Variation|Geometric Mean
2666312|NCT01525238|Primary|Geometric Mean of Apparent Clearance After Extravascular Administration (CL/F) of Dapagliflozin|Apparent clearance after extravascular administration (CL/F) of Dapagliflozin was derived from plasma concentrations versus time data. Geometric means are reported in milliliters per minute (mL/min).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2666314|NCT01525238|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin|Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2666315|NCT01525238|Primary|Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin|Area under the plasma concentration-time curve from time zero extrapolated to infinite time was derived from concentration versus time data. Geometric means are reported in nanogram hours per milliliter (ng*hr/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2666316|NCT01525238|Primary|Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin|Time of maximum observed plasma concentration (Tmax) for Dapagliflozin was derived from plasma concentrations versus time data. Medians were reported in hours (h).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable PK profiles.|||hours||Full Range|Median
2666317|NCT01525238|Primary|Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin|Maximum observed plasma concentration (Cmax) was measured by plasma concentration of Dapagliflozin over time. The geometric means are reported in nanograms per milliliter (ng/mL).|11 time points: Immediately pre-dose, 0.5, 0.75, 1.0, 1.5, 4, 8, 12, 14, 24, and 48 hours post-dose|All treated participants with evaluable pharmacokinetic (PK) profiles|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2666318|NCT01525225|Secondary|Number of Participants With Marked Chemistry or Hematology Laboratory Abnormalities|Lower limit of normal (LLN); upper limit of normal (ULN); treatment (RX); pre-treatment (Pre-Rx); units per liter (U/L); millimoles per liter (mmol/L). Alkaline phosphatase U/L:>1.25*Pre-RX if Pre-RX >ULN or >1.25*ULN if Pre-RX <=ULN; aspartate aminotransferase U/L: >1.25*Pre-RX if Pre-RX>ULN or 1.25*ULN if Pre-RX<=ULN;alanine aminotransferase U/L: >1.25*Pre-RX if Pre-RX>ULN or 1.25*ULN if Pre-RX<=ULN;blood urea nitrogen mmol/L: >1.1*ULN if Pre-RX <=ULN or >1.2*Pre-RX if Pre-RX >ULN; total bilirubin µmol/L: >1.1*ULN if Pre-RX <=ULN or >1.25*Pre-RX if Pre-RX >ULN; creatine phosphokinase U/L: >1.5*Pre-RX if Pre-RX>ULN or >1.5*ULN if Pre-RX <= ULN. Grams per liter (g/L); cells per liter (c/L). Hemoglobin (g/L): <0.85* pre-RX; hematocrit (%): <0.85*pre-RX;erythrocytes (*10^12 c/L): <0.85*pre-RX; platelet count (*10^9 c/L): <0.85*LLN if pre-RX>=LLN, or if Pre-Tx <LLN; leukocytes (*10^9 c/L): <0.85*LLN if pre-RX <LLN,or <0.9*LLN if LLN<=Pre-RX<=ULN.|Day 1 to Day 8|Participants who received at least one dose of study drug.|||participants|||Number
2666319|NCT01525225|Primary|Number of Participants With Adverse Events (AEs) , Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Death|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Day 1 up to Day 8, plus 30 days|All participants who received at least one dose of study drug.|||participants|||Number
2666320|NCT01525173|Primary|Change From Baseline in Mean Diurnal Intraocular Pressure (IOP)|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the study eye, defined as the worse eye at Baseline. The mean diurnal IOP is the average of all the IOP measurements in the study eye taken at 8 AM, 10 AM and 4 PM at Baseline and at Week 12. A negative change from Baseline indicated improvement.|Baseline, Week 12|Per protocol population included all qualified participants who completed three months of treatment.|||mm Hg||Standard Deviation|Mean
2666321|NCT01524991|Secondary|Number of Adverse Events Experienced by Patients|To determine the safety of treatment with gemcitabine, cisplatin, plus ipilimumab. The highest grade adverse event for each subject is presented.|12 months||||Participants|||Count of Participants
2666322|NCT01524991|Secondary|Best Overall Response Rate|To determine the best overall response rate to treatment with gemcitabine, cisplatin, plus ipilimumab, per RECIST 1.1 criteria.|12 months||||Participants|||Count of Participants
2666323|NCT01524991|Secondary|Progression-Free Survival|"To determine the progression-free survival (using irRC and RECIST v1.0) of patients with advanced/metastatic urothelial carcinoma treated with gemcitabine, cisplatin, and ipilimumab.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression is definied by IrRC as at least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 wk apart."|12 months||||months||95% Confidence Interval|Median
2666324|NCT01524991|Primary|Median Overall Survival|To determine the median overall survival of patients with advanced/metastatic urothelial cancer treated with gemcitabine, cisplatin, plus ipilimumab, calculated from the date of registration until the date of final analysis, projected to be 48 months from the start of the study.|48 months||||months||95% Confidence Interval|Median
2666325|NCT01524978|Secondary|Safety: Percentage of Participants With Adverse Event|An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to approximately 3 years|The safety population included all participants who received at least one dose of study medication.|||percentage of participants|||Number
2666344|NCT01524900|Secondary|Change in CD4+ Cell Count From Baseline to Week 24|The change in the Cluster of differentiation 4 (CD4+) cell count from baseline after 24 weeks was calculated by subtracting the baseline value from the value after 24 weeks. Therefore, a positive change represents an increase in CD4+ cell count.|baseline and week 24|Patients from FAS with documented CD4+ at baseline and after 24 weeks.|||cells/mm^3||Standard Deviation|Mean
2666326|NCT01524978|Secondary|Number of Dose-limiting Toxicities of Vemurafenib in Combination With Cetuximab|Cohort 3b included participants with colorectal cancer treated with escalating doses of vemurafenib and cetuximab. The escalating doses were as follows: Dose Level 1: 720 milligrams (mg) of vemurafenib orally twice daily starting on Day 2 of Cycle 1 and 300 milligrams per square meter (mg/m^2) loading dose of cetuximab by infusion and then 200 mg/m^2 weekly; Dose Level 2: 720 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m^2 loading dose of cetuximab and then 250 mg/m^2 weekly; Dose Level 3: 960 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m^2 loading dose of cetuximab and then 250 mg/m^2 weekly. Reported here are type and number of dose limited toxicities observed.|Up to 28 days|All participants from Cohort 3b who received at least one dose of study medication.|||dose-limiting toxicities|||Number
2666327|NCT01524978|Secondary|Maximum Tolerated Dose for Vemurafenib in Combination With Cetuximab|Cohort 3b included participants with colorectal cancer treated with escalating doses of vemurafenib and cetuximab. The escalating doses were as follows: Dose Level 1: 720 milligrams (mg) of vemurafenib orally twice daily starting on Day 2 of Cycle 1 and 300 milligrams per square meter (mg/m^2) loading dose of cetuximab by infusion and then 200 mg/m^2 weekly; Dose Level 2: 720 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m^2 loading dose of cetuximab and then 250 mg/m^2 weekly; Dose Level 3: 960 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m^2 loading dose of cetuximab and then 250 mg/m^2 weekly. Reported here are the maximum tolerated doses for each vemurafenib and cetuximab.|Up to approximately 3 years|All participants from Cohort 3b who received at least one dose of study medication.|||milligrams (mg)|||Number
2666328|NCT01524978|Secondary|Overall Survival (OS)|OS was defined as time between the first day of study treatment and date of death of any cause.|Up to approximately 3 years|ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.|||months||95% Confidence Interval|Median
2666329|NCT01524978|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the first day of study treatment, until the first documented PD or death from any cause, whichever occurs first. RECIST v1.1: PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. IMWG criteria: PD: increase of >/= 25% from lowest response value in serum or urine M-protein or bone marrow plasma cell percentage or development of new or increase in size of bone lesions or soft tissue plasmacytomas.|Up to approximately 3 years|ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.|||months||95% Confidence Interval|Median
2666330|NCT01524978|Secondary|Time to Tumor Progression (TTP)|TTP was defined as time from the first day of study treatment to the first occurrence of progressive disease (PD). RECIST v1.1: PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. IMWG: PD: increase of >/= 25% from lowest response value in serum or urine M-protein or bone marrow plasma cell percentage or development of new or increase in size of bone lesions or soft tissue plasmacytomas.|Up to approximately 3 years|ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.|||months||95% Confidence Interval|Median
2666331|NCT01524978|Secondary|Time to Response|Time to response was defined as the time from the first day of study treatment to the date of first CR, or PR for solid tumors according to RECISTv1.1 and CR, PR, VGPR or sCR for multiple myeloma according to IMWG criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of diameters of target lesions. IMWG criteria: CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and </= 5% plasma cells in bone marrow; PR: >/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >/= 90% or to < 200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hour; sCR: CR plus normal FLC ratio and no clonal cells in bone marrow.|Up to approximately 3 years|ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.|||months||95% Confidence Interval|Median
2666332|NCT01524978|Secondary|Duration of Response (DOR)|DOR was defined as the period from the date of initial PR or CR for solid tumors according to RECISTv1.1 and CR, PR, VGPR or sCR for multiple myeloma according to IMWG criteria, until the date of PD or death from any cause. RECIST v1.1: PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. IMWG: PD: increase of >/= 25% from lowest response value in serum or urine M-protein or bone marrow plasma cell percentage or development of new or increase in size of bone lesions or soft tissue plasmacytomas.|Up to approximately 3 years|ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.|||months||95% Confidence Interval|Median
2666333|NCT01524978|Secondary|Overall Response Rate (ORR)|ORR: percentage of participants with an objective response (OR) (CR, PR, sCR or VGPR) on 2 occasions >/= 4 weeks apart as assessed by the Investigator using RECIST v1.1. or IMWG criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: >/= 30% decrease in the sum of diameters of target lesions. IMWG: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and </= 5% plasma cells in bone marrow; PR: >/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >/= 90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hour; sCR: CR plus normal FLC ratio and no clonal cells in bone marrow.|Up to approximately 3 years|ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.|||percentage of participants||95% Confidence Interval|Number
2666358|NCT01524887|Primary|Change From Baseline to Month 18 in Alzheimer´s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL) Inventory|"The ADCS-ADL scale is a validated tool to assess instrumental and basic activities of daily living based on a 23 item structured interview of the caregiver or qualified study partner.~Scores on the ADCS-ADL range from 0-78 with lower scores indicating greater impairment; hence decreases from baseline reflect potential functional deterioration."|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.|||Scores on a scale||Standard Deviation|Mean
2666334|NCT01524978|Secondary|Percentage of Participants With Confirmed Clinical Benefit|Included were participants with confirmed PR or CR or Stable Disease (SD) that had lasted at least 6 months according to RECIST v1.1 or confirmed CR, PR, VGPR, sCR or SD for at least 6 months according to IMWG criteria. RECIST v1.1: PR: >/= 30% decrease in the sum of diameters of target lesions; CR: disappearance of all target lesions; SD: not meeting criteria for CR, PR or progressive disease (PD). IMWG: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and </= 5% plasma cells in bone marrow; PR: >/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >/= 90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hour; sCR: CR plus normal FLC ratio and no clonal cells in bone marrow; SD: not meeting criteria for CR, VGPR, PR or PD.|Up to approximately 3 years|ITT population included all participants enrolled in the study irrespective of whether they had received study medication or not.|||percentage of participants||95% Confidence Interval|Number
2666335|NCT01524978|Primary|Confirmed Best Overall Response Rate (BORR)|Confirmed BORR: percentage of participants with an objective response (OR) (complete response [CR], partial response [PR], stringent CR [sCR] or very good PR [VGPR]) on 2 occasions >/= 4 weeks apart as assessed by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. or International Myeloma Working Group (IMWG) criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: >/= 30% decrease in the sum of diameters of target lesions. IMWG: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and </= 5% plasma cells in bone marrow; PR: >/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >/= 90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hour; sCR: CR plus normal free light chain (FLC) ratio and no clonal cells in bone marrow.|Up to approximately 3 years|ITT population included all participants enrolled in the study irrespective of whether they had received study drug or not.|||percentage of participants||95% Confidence Interval|Number
2666336|NCT01524913|Secondary|Jaw Function Limitation Scale (JFLS) Score|"The Jaw Function Limitation Scale (JFLS) is an 8 item survey where respondents indicate the presence or absence of problems with chewing, drinking, eating hard food, eating soft food, smiling or laughing, yawning, swallowing, and talking. Responses of no are scored as 0 and responses of yes are scored as 1. The total score categorizes jaw limitation as: none (0), mild (1-3), moderate (4-6), and severe (7-8)."|Month 3|The population at this time point consists of study participants who received the intervention they were randomized to, were not lost to follow-up before the Month 3 visit, and completed assessments at the Month 3 visit (one participant did not provide JFLS data at the Month 3 time point).|||Participants|||Count of Participants
2666337|NCT01524913|Secondary|Jaw Function Limitation Scale (JFLS) Score|"The Jaw Function Limitation Scale (JFLS) is an 8 item survey where respondents indicate the presence or absence of problems with chewing, drinking, eating hard food, eating soft food, smiling or laughing, yawning, swallowing, and talking. Responses of no are scored as 0 and responses of yes are scored as 1. The total score categorizes jaw limitation as: none (0), mild (1-3), moderate (4-6), and severe (7-8)."|Month 1|The population at this time point consists of study participants who received the intervention they were randomized to and were not lost to follow-up before the Month 1 visit.|||Participants|||Count of Participants
2666338|NCT01524913|Secondary|Change in Maximum Incisal Opening (MIO) Between Baseline, Month 1, and Month 3|Range of motion was assessed at Baseline (preoperatively) and again at Months 1 and 3 using a millimeter ruler for maximum incisal opening. MIO was measurements were taken for maximum opening without and with pain.|Baseline (preoperation), Month 1, Month 3|The population for MIO analysis consists of participants having a measurement at each specified time point. The decline in the number of participants over time is due to participants who were lost to follow-up as the study progressed and one participant who attended the Month 3 visit but did not provide data for the MIO assessment.|||millimeters||Standard Deviation|Mean
2666339|NCT01524913|Primary|Change in Pain Between Baseline and Month 1 Scores|The change in pain level was assessed using a single-item visual analogue pain scale at Baseline (preoperatively) and at Month 1. Participants indicate their level on pain on a scale of 0 (no pain) to 10 (worst pain imaginable). The right and left side of each participant's jaw was evaluated separately. The change in pain score was obtained by subtracting the Month 1 score from the Baseline score and a negative value indicates a reduction in pain level.|Baseline (preoperation), Month 1|The population at this time point consists of study participants who received their assigned intervention and were not lost to follow up by the Month 1 assessment.|||units on a scale||Standard Deviation|Mean
2666340|NCT01524900|Primary|Number of Patients Reporting Hepatic Events|Number of patients reporting hepatic events either as adverse event (AE) or as laboratory abnormality of Grade 1 to Grade 4 in aspartate aminotransferase (AST), alanine transaminase (ALT), Gamma-Glutamyl-Transferase (Gamma-GT) and bilirubin.|up to 72 weeks||||participants|||Number
2666341|NCT01524900|Primary|Number of Patients Reporting Rash of Any Severity|Number of patients reporting rash of any severity as adverse event|up to 72 weeks|Patients TS|||participants|||Number
2666342|NCT01524900|Secondary|Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation|The number of patients reporting that they find the once daily nevirapine intake more / very much more convenient than the twice daily formulation.|24 weeks|Patients from FAS|||participants|||Number
2666343|NCT01524900|Secondary|Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks|The Morisky Medication Adherence scale (MMAS-8 scale) is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score after 24 weeks minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.|baseline and week 24|Patients from FAS with documented MMAS-8 score at baseline and after 24 weeks.|||units on a scale||Standard Deviation|Mean
2667774|NCT01512225|Primary|Increase in Breast Milk Production|The primary outcome is the difference in the proportion of women having a 50% increase in breast milk volume at the end of 14 days of treatment with domperidone compared to mothers receiving placebo (mean day 14 volume minus mean day 0 volume at entry).|Day 0 to day 14||||Participants|||Count of Participants
2666345|NCT01524900|Secondary|Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL)|Virologic response is defined as confirmed Human Immunodeficiency Virus (HIV) viral load of < 50 copies/mL (at two consecutive measurements after baseline) up to week 24 and without subsequent rebound or change of anti-retroviral (ARV) therapy up to week 24. A rebound is defined as two consecutive measurements of viral load (VL) ≥ 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL< 50 copies/mL. A change of ARV therapy is defined as a permanent discontinuation of nevirapine extended release, addition of new ARV drugs, or alteration in background therapy. A change in the background therapy due to toxicity or intolerance is not considered as treatment failure. If no follow-up viral load was available the virologic response is Missing.|24 weeks|Patients from the Full analysis set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.|||participants|||Number
2666346|NCT01524900|Primary|Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation|The primary endpoint is to evaluate the safety of a highly active antiretroviral therapy (HAART) that includes nevirapine extended release in routine clinical practice which is to assess the number of patients reporting non-serious adverse events (nSAEs), the number of patients with serious adverse events (SAE), the number of patients with non-serious adverse events leading to treatment discontinuation, and the number of patients with serious adverse events leading to discontinuation.|up to 72 weeks|Patients from TS.|||participants|||Number
2666347|NCT01524887|Secondary|Number of Infusions Discontinued, Slowed, or Interrupted Due to an AE||Throughout infusions, approximately 2-5 hours|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.|||infusions|Total number of infusions administered||Number
2666348|NCT01524887|Secondary|Number of Infusions Causally Associated With AEs and/or SAEs||Throughout the study period: 18 Months|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.|||infusions|Total number of infusions administered||Number
2666349|NCT01524887|Secondary|Number of Infusions Associated With AEs and/or SAEs Occurring During or Within 7 Days of Completion of an Infusion||During or within 7 days of completion of an infusion||||infusions|Total number of infusions administered||Number
2666350|NCT01524887|Secondary|Number of Infusions Temporally Associated With AEs and/or SAEs|A temporal association was defined as an AE and/or SAE occurring during or within 72 hours of completion of an infusion, regardless of causality.|During or within 72 hours of completion of an infusion|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.|||infusions|Total number of infusions administered||Number
2666351|NCT01524887|Secondary|Number of Participants Experiencing Any AEs and/or SAEs||Throughout the study period: 18 Months|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.|||participants|||Number
2666352|NCT01524887|Secondary|Number of Participants Experiencing Study Product-related Adverse Events (AEs) and/or Serious Adverse Events (SAEs)||Throughout the study period: 18 Months|The safety analysis population includes the 251 subjects who received at least 1 infusion of investigational product.|||participants|||Number
2666353|NCT01524887|Secondary|Change From Baseline to Month 18 in Impact of Alzheimer´s Disease on Caregiver Questionnaire (IADCQ)|The IADCQ is a 12-item validated questionnaire that has been developed to measure the emotional, physical, and social impact of care giving on AD caregivers. Higher scores on the IADCQ are associated with a higher impact. IADCQ total score range: 0 (no impact) - 48 (greatest impact). Each item can be scored either 0 (Not at all), 1 (A little), 2 (Somewhat), 3 (A lot), or 4 (Extremely). As this is a 12-item scale, the minimum possible score is 0 and the maximum possible score is 4x12 = 48.|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.|||Scores on a scale||Standard Deviation|Mean
2666354|NCT01524887|Secondary|Change From Baseline to Month 18 in Logsdon Quality of Life in Alzheimer´s Disease (QOL-AD)|The QOL AD is a validated, 13-item instrument developed specifically for individuals with dementia. The assessment rates the participant´s quality of life for physical, emotional, interpersonal, and environmental domains. The QOL-AD total score ranged 13-52, with lower scores associated with a lower quality of life.|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.|||Scores on a scale||Standard Deviation|Mean
2666355|NCT01524887|Secondary|Change From Baseline to Month 18 in Volumetric Magnetic Resonance Imaging (MRI) Parameters: Rate of Whole Brain Atrophy and Ventricular Enlargement||Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.|||mm^3||Standard Deviation|Mean
2666356|NCT01524887|Secondary|Change From Baseline to Month 18 in Neuropsychiatric Inventory (NPI)|The NPI is a validated instrument used to assess behavioral psychopathology in AD; it evaluates the frequency and severity of 10 neuropsychiatric features including delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, aberrant motor activity, sleep and night-time behavior change, and appetite and eating change. The NPI total score ranged 0-144, with higher scores indicating greater impairment.|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.|||Scores on a scale||Standard Deviation|Mean
2666357|NCT01524887|Secondary|ADCS-Clinical Global Impression of Change (CGIC) at 18 Months|The ADCS-CGIC is a validated categorical measure of change in a participant's global clinical status between baseline and follow-up visits, based on interview of the participant and the caregiver by a skilled and experienced clinician who was blinded to treatment assignment. The ADCS-CGIC score is based on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening).|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2668603|NCT01504867|Primary|Number of Participants Who Developed Acute Respiratory Distress Syndrome (ARDS) Within 7 Days|ARDS was defined by Berlin criteria (modified to require invasive mechanical ventilation) within 7 days of hospital admission.|Within seven days from hospital presentation|Intention-to-Treat|||participants|||Number
2666359|NCT01524887|Primary|Change From Baseline to Month 18 in Cognitive Subscale of the Alzheimer´s Disease Assessment Scale (ADAS-Cog)|"The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at each site.~Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater impairment; hence increases from baseline reflect potential cognitive deterioration."|Baseline to 9 Months (actual time frame)|Because this study was terminated early, 9-month analyses were conducted in the subset of participants that completed at least 9 months of treatment.|||Scores on a scale||Standard Deviation|Mean
2666360|NCT01524796|Secondary|Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)|Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category.|After Baseline, Month 1, 2, 3 visit|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. Here “n” signifies pharmacological treatments received at the specified time point.|||Participants|Participants||Number
2666361|NCT01524796|Secondary|Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit|Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category.|Before Baseline, Month 1, 2, 3 Visit|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. Here “n” signifies pharmacological treatments received at the specified time point.|||Participants|Participants||Number
2666362|NCT01524796|Secondary|Pregabalin Dose|"Here, n signifies Number of participants for Baseline and Month 3 telephone interview whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview."|After Baseline Visit; Prior to Month 1, 2, 3, Month 3 Telephonic Interview; After Month 1, 2, 3, Month 3 Telephonic Interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. For Baseline and Month 3 telephonic interview, “n” signifies those participants who were evaluable for this outcome. For Month 1 to Month 3, “n” signifies number of observations.|||Milligram (mg) per day||Standard Deviation|Mean
2666363|NCT01524796|Secondary|Work Productivity and Activity Impairment (WPAI) Questionnaire|"WPAI questionnaire assess work productivity and impairment. It is a patient-rated, six-item questionnaire regarding current employment, hours missed and actually worked, and degree to which a specified health problem affected work productivity and regular activities over the past seven days. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, n signifies Number of participants for Baseline whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview."|Baseline, Month 1, 2, 3|Safety analysis set included those participants who received at least 1 dose of the drug under study. Here number of participants analyzed “N” signifies those participants who were evaluable for this measure. For Baseline, “n”=those participants who were evaluable for this outcome. For Month 1 to Month 3, “n”=number of observations.|||Units on a scale||Standard Deviation|Mean
2666364|NCT01524796|Secondary|Health-related Quality of Life Scale Score|"Health-related Quality of Life was measured using Euro Quality of Life-5 dimensions (EQ-5D) scale. EQ-5D is a standardized generic instrument to assess health-related quality of life on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The scale rates current participant's health state on a scale from 0 (worst imaginable health state) to 1 (best imaginable health state); higher scores indicate a better health state. Here, n signifies Number of participants for Baseline whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview."|Baseline, Month 1, 2, 3|Safety analysis set included those participants who received at least 1 dose of the drug under study. Here number of participants analyzed “N” signifies those participants who were evaluable for this measure. For Baseline, “n”=those participants who were evaluable for this outcome. For Month 1 to Month 3, “n”=number of observations.|||Units on a scale||Standard Deviation|Mean
2666365|NCT01524796|Secondary|Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C)|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.|Month 3 telephonic interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.|||Participants|||Number
2666395|NCT01524302|Secondary|Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Community-Acquired Bacterial Pneumonia Patients|To determine the serum pharmacokinetic clearance of drug parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.|2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion||||liters per hour||Standard Deviation|Mean
2668284|NCT01507233|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order written or Day 30, whichever is sooner|As no subjects received EXPAREL in this study, statistical analyses were not performed.||||||
2666366|NCT01524796|Secondary|Sleep Interference Scale Score|"Sleep Interference was assessed on an 11-point Sleep Numeric Rating Scale (NRS-11) where a score of 0 indicated pain did not interfere with sleep and a score of 10 indicated pain completely interfered with sleep. Here, n signifies Number of participants for Baseline and Month 3 telephone interview whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview."|Baseline, Month 1, 2, 3, Month 3 telephonic interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up. For Baseline and Month 3 telephonic interview, “n” signifies those participants who were evaluable for this outcome. For Month 1 to Month 3, “n” signifies number of observations.|||Units on a scale||Standard Deviation|Mean
2666367|NCT01524796|Primary|Change From Baseline In Least Pain Level At Month 3 Telephonic Interview|"Pain was assessed on an 11-point NRS where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline, Month 3 Telephonic Interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.|||Units on a scale||Standard Deviation|Mean
2666368|NCT01524796|Primary|Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview|"Pain was assessed on an 11-point NRS where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline, Month 3 Telephonic Interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.|||Units on a scale||Standard Deviation|Mean
2666369|NCT01524796|Primary|Change From Baseline In Average Pain Level At Month 3 Telephonic Interview|"Pain was assessed on an 11-point numeric rating scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine."|Baseline, Month 3 Telephonic Interview|Analysis population included all participants on pregabalin (Lyrica) at three months follow-up.|||Units on a scale||Standard Deviation|Mean
2666370|NCT01524783|Secondary|Pharmacokinetics (PK)|A single blood sample to determine the exposure of everolimus at the steady-state pre-dose concentration (Cmin).|Visit 3 (Cycle 2, Study Day 29)||2020-07-31|07/2020||||
2666371|NCT01524783|Secondary|Time to Definitive Deterioration in WHO Performance Status Change During the Study|The estimated average duration is at least 5-8.5 months until disease progression. WHO Performance Status is a scale rated from 0 (normal) to 5 (dead) by a healthcare professional to assess the overall status of a patient. Deterioration is defined as an increase of at least one category compared to baseline.|Every visit up from randomization to 5 years||2020-07-31|07/2020||||
2666372|NCT01524783|Secondary|Change in Chromogranin A (CgA) and Neuron Specific Enolase (NSE) Levels During the Study|The estimated average treatment duration is at least 5-8.5 months until disease progression. CgA and NSE are potential biomarkers for tumor response. Change from baseline will be noted and correlated with tumor response.|Every visit from baseline up to 5 years||2020-07-31|07/2020||||
2666373|NCT01524783|Secondary|Disease Control Rate (DCR)|The estimated average treatment duration is at least 5-8.5 months until disease progression. DCR will be assessed per modified RECIST 1.0. DCR is the proportion of patients with best overall response of CR, PR or stable disease (SD).|5 years||2020-07-31|07/2020||||
2666374|NCT01524783|Secondary|Objective Response Rate (ORR)|ORR will be assessed per modified RECIST 1.0. ORR is the proportion of patients with a best overall response of complete response (CR) or partial response (PR).|Every Visit from randomization up to 5 years||2020-07-31|07/2020||||
2666375|NCT01524783|Secondary|FACT-G Total Score Over the Duration of the Study|FACT-G is a self-assessed health-related quality of life questionnaire. The questionnaire is comprised of 27 questions, scored 0 to 4, examining physical, social/family, emotional, and functional well-being. Deterioration is defined as a decrease by at least 7 points compared to baseline.|Every Visit from randomization up to 5 years||2020-07-31|07/2020||||
2666376|NCT01524783|Secondary|Overall Safety Evaluation of Everolimus Versus Placebo|The assessment of safety will be based mainly on the frequency and type of treatment emergent adverse events and on the number of laboratory values that fall outside of pre-determined ranges. Other safety data (e.g. vital signs) will be considered as appropriate. Safety events will be graded using the CTCAE V4.03 (Common Terminology Criteria for Adverse Events).|Every visit from randomization up to 5 years||2020-07-31|07/2020||||
2666377|NCT01524783|Secondary|Overall Survival (OS) Using Kaplan-Meier|OS is defined as the time from the date of randomization to date of death due to any cause.|Every visit from randomization up to 18 months|The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.|||Percentage of participants||95% Confidence Interval|Number
2666378|NCT01524783|Primary|Progression Free Survival (PFS) Based on Central Radiology Assessment Per Kaplan-Meier|PFS is defined as the time from randomization to the date of the first documented tumor progression as per modified RECIST 1.0 or death from any cause, whichever comes first. Progression is assessed by cat scan (CT) and/or magnetic resonance imaging (MRI).|From date of randomization to progression or death up to 18 months|The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.|||Percentage of participants||95% Confidence Interval|Number
2666379|NCT01524770|Secondary|Pharmacokinetics: Time to Maximum Concentration (Tmax) for Dulaglutide||Predose to 336 hours postdose|Participants who received at least 1 dose of dulaglutide with evaluable concentration-time data.|||hours||Full Range|Median
2666380|NCT01524770|Primary|Pharmacokinetics: Maximum Concentration (Cmax) for Dulaglutide||Predose to 336 hours postdose|Participants who received at least 1 dose of dulaglutide and have evaluable dulaglutide concentration data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2666381|NCT01524770|Primary|Pharmacokinetics: Area Under the Concentration Curve (AUC[0-336]) for Dulaglutide||Predose to 336 hours postdose|Participants who received at least 1 dose of dulaglutide and have evaluable dulaglutide concentration data.|||nanograms times hours per milliliters||Geometric Coefficient of Variation|Geometric Mean
2666382|NCT01524692|Secondary|Expression of MYB Protein and Chromosomal Rearrangements of the MYB Locus|Assess archival tumor samples for the expression of MYB protein and chromosomal rearrangements of the MYB locus.|Anticipated Reporting Date 2020||2020-12-31|12/2020||||
2666383|NCT01524692|Secondary|Feasibility of Measuring and Analyzing TKI258 Induced Changes in the Growth Rate of Adenoid Cystic Carcinomas.|Collect descriptive data about the change in tumor growth rates as measured by the change point method. Tumor growth rate is defined as the estimated slope (slope is then defined as Y1-Y0 divided by X1-X0) from tumor measurements taken prior to treatment (TG0). TG0 is compared with TG1 (tumor growth rate) as defined by the estimated slope after treatment (comparing time 0 to 4mo). Each patient's tumor growth profile is allowed one slope measured from pre-study (-6 months to time 0), and the other slope (time 0 to time 4 months). Change between those 2 slopes is reported. Slope is measured on a plot of time on the x axis and sum of longest diameters of RECIST target lesions on the y axis. The slope of the tumor growth curve (plotted as sum of longest diameters vs month since starting dovitinib) is measured at time points -6mo, 0, and 4 months. Pre-study scans (-6mo) were required of all patients and on-study scans were at times, 0, 2, 4months, 8months, 12mo, 16mo.|All patients provided pre-study scans with target lesions. The target lesions from pre-study scans were compared to the target lesions on the baseline scan at time 0. TG0 was measured from -6 months to time 0. TG1 is defined as time 0 to time 4 months.|All treated patients were required to submit pre-study cross sectional imaging from preceeding 6months in order to establish pre-study tumor growth rates. On-study scans were performed at time 0, 2, 4 months, 8, months, 12 months, 16 months.|||cm/month||Standard Error|Mean
2666384|NCT01524692|Secondary|Quality of Life Measurements During TKI258 Treatment.|Participants were asked to fill out FACT-G (Functional Assessment of Chronic Illness Therapy) quality of life questionnaires at baseline and off-treatment visit (average 8.2 months). This scale measures physical well-being, social/family well-being, emotional well-being, and functional well-being on a 5 point Likert scale. Scores range from 0 to 4 on a Likert scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The raw score range for each subscale is 0-28 points and the total score range is 0-108. Higher values represent higher well-being in each functional subscale. The mean difference from baseline to off-study assessment are presented with range from minimum to maximum.|Baseline FACT-G questionnaire and FACT-G questionnaire at time of off-treatment visit (average of 8.2 months)|All participants filled out quality of life questionnaires.|||units on a scale||Full Range|Mean
2666385|NCT01524692|Secondary|The Adverse Event Profile of TKI258 in Subjects Who Have ACC.|Adverse events were collected per CTCAE v3.|From enrollment up to 36months||||Participants|||Count of Participants
2666386|NCT01524692|Secondary|Estimate the Progression-free Survival Following Treatment With TKI258.|PFS is measured from enrollment up to first progression event (median= 8.2 months). 1 patient was not evaluable for response evaluation due to withdrawal prior to first interval scan.|From enrollment up to first progression event||||Months||90% Confidence Interval|Median
2666387|NCT01524692|Primary|Determine the Objective Tumor Response Rate Following Treatment With TKI258|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by cross sectional imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|From enrollment up to 36months|1 patient was not evaluable for response evaluation due to withdrawal prior to first interval scan.|||Participants|||Count of Participants
2666388|NCT01524679|Secondary|Change in Quantitative HBs Antigen at Week 24|Change in quantitative HBs antigen at week 24. The data were log transformed before analysis and the changes to baseline were analysed. Therefore, the reported values might be interpreted as percentage changes. Lower scores mean a better outcome.|week 24|Values were only available in 151 patients.|||IU/ml||95% Confidence Interval|Geometric Least Squares Mean
2666389|NCT01524679|Secondary|Change in Quantitative HBs Antigen at Week 12|Change in quantitative HBs antigen at week 12. The data were log transformed before analysis and the changes to baseline were analysed. Therefore, the reported values might be interpreted as percentage changes. Lower scores mean a better outcome.|week 12|Values were only available in 154 patients.|||IU/ml||95% Confidence Interval|Geometric Least Squares Mean
2666390|NCT01524679|Primary|Difference in Percentage of Patients Between Treatment and Comparator Arm Reaching a ≥ 1log10 Decline of Quantitative HBsAg After 48 Weeks|Difference in percentage of patients between treatment and comparator arm reaching a ≥ 1log10 decline (tenfold reduction) of quantitative HBsAg after 48 weeks|48 weeks|mITT population consisting of all randomized patients with at least one post-baseline measurement|||Participants|||Count of Participants
2666391|NCT01524627|Primary|Cigarettes Per Day|Cigarettes per day at Baseline versus 8 weeks of treatment, placebo-controlled|last week of treatment (1-8 weeks)|Population was the number of randomized subjects who participated in any treatment length. One subject per group was not included in this analysis as one withdrew a few days after their first scan and the other was lost to follow up after their first scan.|||cigarettes per day||Standard Error|Mean
2666392|NCT01524302|Primary|Serum Cidal Activity as Tested Against Staphylococcus Aureus Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)|"Serum cidal activity of serum collected at 2 hour (levofloxacin) and 12 hour (ceftaroline) time points from the patients was tested against methyicillin-sensitive staphylococcus aureus isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth).~These staphylococcus aureus isolates had a range of minimum inhibitory concentrations (MIC) to Levofloxacin, 0.5, 1.0, 2.0, and 4.0 and the MIC's to Ceftaroline were 0.125, 0.19, 0.094, 0.094, respectively."|2 hour (levofloxacin) and 12 hour (ceftaroline) after receiving the drug||||Log inhibition|||Number
2666393|NCT01524302|Secondary|Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Community-Acquired Bacterial Pneumonia Patients.|To determine the serum pharmacokinetic Area Under Serum Curve parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.|2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion||||mg*hr/L||Standard Deviation|Mean
2666394|NCT01524302|Secondary|Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic (PK) Half Life Parameter in Community-Acquired Bacterial Pneumonia Patients|To determine the serum pharmacokinetic half life parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.|2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion||||hours||Standard Deviation|Mean
2666396|NCT01524302|Secondary|Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic Volume of Distribution Parameter in Community-Acquired Bacterial Pneumonia Patients|To determine the serum pharmacokinetic volume of distribution of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.|2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion||||Liters||Standard Deviation|Mean
2666397|NCT01524289|Secondary|Percent Change From Baseline in Lipoprotein(a) (Lp[a]) Levels|The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of lipoprotein(a) (Lp[a]) for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.|Baseline and Week 52|The FAS population consisted of all randomized participants who received at least one dose of study treatment and had at least one post randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that require baseline data.|||Percent Change||95% Confidence Interval|Number
2666398|NCT01524289|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) A-1 Levels|The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of Apo A-1 for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.|Baseline and Week 52|The FAS population consisted of all randomized participants who received at least one dose of study treatment and had at least one post randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that require baseline data.|||Percent Change||95% Confidence Interval|Number
2666399|NCT01524289|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B Levels|The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of apolipoprotein (Apo) B for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.|Baseline and Week 52|The FAS population consisted of all randomized participants who received at least one dose of study treatment and had at least one post randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that require baseline data.|||Percent Change||95% Confidence Interval|Number
2666400|NCT01524289|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol Levels|The efficacy of adding anacetrapib 100 mg was evaluated relative to placebo on plasma concentrations of non-high-density lipoprotein cholesterol (HDL-C) for the FAS population at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.|Baseline and Week 52|The FAS population consisted of all randomized participants who received at least one dose of study treatment and had at least one post randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that require baseline data.|||Percent Change||95% Confidence Interval|Least Squares Mean
2666401|NCT01524289|Secondary|Percent Change From Baseline in High-Density Lipoprotein Cholesterol Levels|The efficacy of adding anacetrapib 100 mg relative to placebo on plasma concentrations of high-density lipoprotein cholesterol (HDL-C) was evaluated at Week 0 (start of treatment phase) and Week 52 (end of treatment phase) or at discontinuation.|Baseline and Week 52|The FAS population consisted of all randomized participants who received at least one dose of study treatment and had at least one post randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for those analyses that require baseline data.|||Percent Change||95% Confidence Interval|Least Squares Mean
2666402|NCT01524289|Primary|Percentage of Participants Who Died From Any Cause - Treatment Phase|The percentage of participants who died from any cause during the treatment phase is presented. All deaths were adjudicated by an expert committee independent of the Sponsor.|Up to 52 weeks|The APaT population consisted of all randomized participants who received at least one dose of study treatment.|||Percentage of Participants|||Number
2666403|NCT01524289|Primary|Percentage of Participants Adjudicated Cardiovascular (CV) SAE|An AE or suspected adverse reaction was considered an SAE if it resulted in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. All events were adjudicated by an expert committee independent of the Sponsor. The percentage of participants that experienced adjudicated SAEs of CV death, non-fatal stroke, non-fatal myocardial infarction, or unstable angina during the treatment phase is presented.|Up to 52 weeks|The APaT population consisted of all randomized participants who received at least one dose of study treatment.|||Percentage of Participants|||Number
2666404|NCT01524289|Primary|Percentage of Participants With CK Level >=10 x ULN With Muscle Spasms|Participants had CK levels assessed throughout the 52-week treatment period. The percentage of participants who had any CK level that was >=10 x ULN and had associated muscle spasms during the treatment phase is presented.|Up to 52 weeks|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one post-baseline test result that met pre-determined criteria.|||Percentage of Participants|||Number
2666405|NCT01524289|Primary|Percentage of Participants With Creatine Kinase (CK) Level >=10 x ULN|Participants had CK levels assessed throughout the 52-week treatment period. The percentage of participants who had any CK level that was >=10 x ULN during the treatment phase is presented.|Up to 52 weeks|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one post-baseline test result that met pre-determined criteria.|||Percentage of Participants|||Number
2666406|NCT01524289|Primary|Percentage of Participants With Consecutive Changes in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) of >=3 x ULN|Participants had AST and ALT levels assessed throughout the 52-week treatment period. The percentage of participants who had 2 consecutive assessments of either AST or ALT that were 3 x ULN or greater during the treatment phase is presented.|Up to 52 weeks|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one post-baseline test result that met pre-determined criteria.|||Percentage of Participants|||Number
2666441|NCT01523886|Secondary|Surgical Space Conditions|The surgical space conditions (VAS 0-100) assessed at the time during surgery, when they were poorest|From surgical incision to last suture has been placed, an expected average of 30 minutes.|||||||
2666407|NCT01524289|Primary|Percentage of Participants With Bicarbonate Levels > ULN|Participants had bicarbonate levels assessed throughout the 52-week treatment period. The percentage of participants who had any bicarbonate level that was > the ULN of 33 mEq/L during the treatment phase is presented.|Up to 52 weeks|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one post-baseline test result that met pre-determined criteria.|||Percentage of Participants|||Number
2666408|NCT01524289|Primary|Percentage of Participants With Potassium Levels < Lower Limit of Normal (LLN)|Participants had potassium levels assessed throughout the 52-week treatment period. The percentage of participants who had any potassium level that was < the LLN of 3.5 mEq/L during the treatment phase is presented.|Up to 52 weeks|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one post-baseline test result that met pre-determined criteria.|||Percentage of Participants|||Number
2666409|NCT01524289|Primary|Percentage of Participants With Chloride Levels > ULN|Participants had chloride levels assessed throughout the 52-week treatment period. The percentage of participants who had any chloride level that was > the ULN of 110 mEq/L during the treatment phase is presented.|Up to 52 weeks|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one post-baseline test result that met pre-determined criteria.|||Percentage of Participants|||Number
2666410|NCT01524289|Primary|Percentage of Participants With Sodium Levels > Upper Limit of Normal (ULN)|Participants had sodium levels assessed throughout the 52-week treatment period. The percentage of participants who had any sodium level that was greater than the ULN of 145 mEq/L during the treatment phase is presented.|Up to 52 weeks|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one post-baseline test result that met pre-determined criteria.|||Percentage of Participants|||Number
2666411|NCT01524289|Primary|Percentage of Participants With Changes in Diastolic Blood Pressure (DBP) >= 10 mm Hg|Participants had DBP assessed at baseline and throughout the 52-week treatment period. The percentage of participants who had a DBP reading that was >= 10 mm Hg higher than their baseline DBP for any assessment performed during the treatment phase is presented.|Up to 52 weeks|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one post-baseline test result that met pre-determined criteria.|||Percentage of Participants|||Number
2666412|NCT01524289|Primary|Percentage of Participants With Changes in SBP >= 15 mm Hg|Participants had SBP assessed at baseline and throughout the 52-week treatment period. The percentage of participants who had a SBP reading that was >= 15 mm Hg higher than their baseline SBP for any assessment performed during the treatment phase is presented.|Up to 52 weeks|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one post-baseline test result that met pre-determined criteria.|||Percentage of Participants|||Number
2666413|NCT01524289|Primary|Percentage of Participants With Changes in Systolic Blood Pressure (SBP) >= 10 mm Hg|Participants had SBP assessed at baseline and throughout the 52-week treatment period. Percentage of participants who had a SBP reading that was >= 10 mm Hg higher than their baseline SBP for any assessment performed during the treatment phase is presented.|Up to 52 weeks|The analysis population consisted of all randomized participants who received at least one dose of study treatment and had at least one post-baseline test result that met pre-determined criteria.|||Percentage of Participants|||Number
2666414|NCT01524289|Primary|Percentage of Participants Discontinuing Study Treatment Due to an Adverse Event - Treatment Phase|An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the drug. Any worsening of a preexisting condition which was temporally associated with the use of the study drug was also an AE. The percentage of participants who discontinued study treatment due to an AE during the treatment phase is presented.|Up to 52 weeks|The APaT population consists of all randomized participants who received at least one dose of study treatment.|||Percentage of Participants|||Number
2666415|NCT01524289|Primary|Percentage of Participants With Any Serious Adverse Event - Treatment Phase|A serious adverse experience (SAE) was any adverse event that occurred at any dose that resulted in death or was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, or was a congenital anomaly/birth defect. The percentage of participants with any serious adverse event during the treatment phase is presented.|Up to 52 weeks|The APaT population consisted of all randomized participants who received at least one dose of study treatment.|||Percentage of Participants|||Number
2666416|NCT01524289|Primary|Percentage of Participants With Any Treatment-Related Adverse Event - Treatment Phase|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the treatment. Any worsening of a preexisting condition which was temporally associated with the use of the study treatment was also an AE. AEs reported by the investigator as definitely, probably or possibly related to study treatment were considered treatment-related. The percentage of participants with any treatment-related adverse event during the treatment phase is presented.|Up to 52 weeks|The APaT population consisted of all randomized participants who received at least one dose of study treatment.|||Percentage of Participants|||Number
2666417|NCT01524289|Primary|Percentage of Participants With Any Adverse Event - Treatment Phase|An adverse event (AE) or experience was any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a study treatment, whether or not considered related to the use of the study treatment. Any worsening of a preexisting condition which was temporally associated with the use of the study treatment is also an AE. The percentage of participants with any adverse event during the treatment phase is presented.|Up to 52 weeks|The all participants as treated (APaT) population consisted of all randomized participants who received at least one dose of study treatment.|||Percentage of Participants|||Number
2666529|NCT01522937|Primary|The Percentage of Patients With Local Control at 1 Year Post Treatment|For this study, local control is defined as the lack of progressive local disease following CR (Complete Response) or PR (Partial Response), or lack of progressive local disease in patients with non-evaluable disease, who have no progressive elevation in serum tumor markers.|1 Year||||percentage of patients||95% Confidence Interval|Number
2666418|NCT01524289|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) - Treatment Phase|LDL-C levels were measured at baseline and week 52 (or at discontinuation) using a beta quantification method. The Treatment Phase was the period from the date of the participant's first dose of study treatment (randomization visit, Visit 3) to the participant's last visit on treatment (discontinuation visit or Visit 8 [Week 52]).|Baseline and Week 52|The full analysis set (FAS) population consisted of all randomized participants who received at least one dose of study treatment, had at least one post randomization observation for the analysis endpoint subsequent to at least one dose of study treatment and had baseline data for those analyses that require baseline data.|||Percent Change||95% Confidence Interval|Least Squares Mean
2666419|NCT01524224|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY2495655||Cycle 1 and Cycle 4 Days 1 (pre-dose, end of infusion, 2hr, 6hr, 10-12hr after the infusion ends) and Day 2, 3, 5, 8|All participants who received at least one dose of study drug and had evaluable pharmacokinetic data.|||nanomolar (nM)||Geometric Coefficient of Variation|Geometric Mean
2666420|NCT01524224|Secondary|Pharmacokinetics (PK): Area Under the Concentration-time Curve From Time 0 to 336 Hours (AUC[0-336]) of LY2495655|AUC(0-336h) is the area under the drug concentration versus time curve within a dosing interval (0-336 hours). Due to the small number per cohort (participants dropping out) calculations of the accumulation factor of exposure for repeated every-other-week dosing were based on simulated area under the drug concentration versus time curve within a dosing interval (AUCτ) instead of observed values. The 90-percentage confidence interval was calculated as the predictive interval.|Cycle 1 and Cycle 4 Days 1 (pre-dose, end of infusion, 2hr, 6hr, 10-12hr after the infusion ends) and Day 2, 3, 5, 8|All participants who received at least one dose of study drug and had evaluable pharmacokinetic data. Confidence Interval calculated as predictive interval and summarized from simulated PK profiles in 1000 virtual participants for each dose using a population PK model for LY2495655.|||micromolar*hr (µM*hr)||90% Confidence Interval|Median
2666421|NCT01524224|Primary|Number of Participants With One or More Drug-related Adverse Events|A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. An AE is summarized if the onset date is on or after the first dose of study drug and within 30 days after the last dose, or it occurred before the first dose of study drug and worsened while on the therapy.|Baseline through End of Study (up to 51 months)|All participants who received at least one dose of study drug.|||Participants|||Count of Participants
2666422|NCT01524198|Secondary|Change in Asthma Score From Baseline as Compared to the Score at Disposition|A negative change of asthma score from baseline measurement to measurement at disposition, which could be at 2, 3, or 4 hours time points would indicate a decrese in asthma severity. The asthma score ranged between 5 and 15 points as in the protocol, where 5 is the mildest and 15 is the most severe.|2, 3, or 4 hours from baseline||||units on asthma score||Standard Deviation|Mean
2666423|NCT01524198|Primary|Patients Hospitalization Rate|The number of patients hospitalized over the study period (17 months).|17 months||||participants|||Number
2666424|NCT01524133|Secondary|Patient Health Questionnaire-15|PHQ-15; measures somatization and ranges from 0 to 30 and 0-9 is considered minimal/low, 10-14 is moderate, and 15-30 is severe|24 weeks|All Randomized patients who received treatment and had the measure|||Scores on a scale||Standard Deviation|Mean
2666425|NCT01524133|Primary|Posttraumatic Stress Disorder (PTSD) Symptoms as Measured by the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)|Total Score; Range 0-136 with increasing PTSD severity as scores increase|24 weeks|All randomized patients who received treatment|||Scores on a scale||Standard Deviation|Mean
2666426|NCT01523964|Primary|Number of Subjects With an Adverse Event.|Adverse events will be assessed during the time the subject is enrolled in the trial.|1 day||||participants|||Number
2666427|NCT01523899|Secondary|Clinical Outcome at One or Three Months|Recurrence of abscess within a three month time period|3 months||||Participants|||Count of Participants
2666428|NCT01523899|Secondary|Participant Clinical Improvement Post-treatment at One Week|clinical improvement (decreasing erythema, pain, swelling, drainage, and presence or absence of fever) will be documented at 2-7 day phone follow up and 1 and 3 months|2 to 7 days||||Participants|||Count of Participants
2666429|NCT01523899|Primary|Number of Participants With Antibiotic Usage at the Time of the ED Visit|Number of Participants with Antibiotic Usage at the time of the ED visit (narrow spectrum, broad spectrum, or none) will be recorded at the time of the ED visit|Baseline||||Participants|||Count of Participants
2666430|NCT01523886|Secondary|Anti-emetics|Use of anti-emetics during the first 24 hours after surgery|During the first 24 hours after surgery|||||||
2666431|NCT01523886|Secondary|Nausea and Vomiting|The incidence of nausea and vomiting during the first 24 hours after surgery|The first 24 hours after surgery|||||||
2666432|NCT01523886|Secondary|Consumption of Analgesics|Consumption of analgesics during the first 24 hours after surgery|The first 24 hours after surgery|||||||
2666433|NCT01523886|Secondary|Duration of Anesthesia|Duration of anesthesia|From induction of anesthesia to patient ready to leave the operating theatre|||||||
2666434|NCT01523886|Secondary|Duration of Surgery|Duration of surgery|From surgical incision to last suture has been placed.|||||||
2666435|NCT01523886|Secondary|Surgical Procedures at Low Pneumoperitoneum|Number of procedures which can be done with pneumoperitoneum 8 mmHg|From surgical incision to last suture has been placed, an expected average of 30 minutes.|||||||
2666436|NCT01523886|Secondary|Normal Functional Level|Numer of days before re-establing normal functional level|from the day of surgery to re-establishing normal functional level - an expected average of 7 days.|||||||
2666437|NCT01523886|Secondary|Pain|Pain (shoulder, incision, deeop abdominal and general) at arrival to the postanesthesia care department, 2 hours and 1 day after surgery.|At arrival to the postanesthesia care department, 2 hours and 1 day after surgery|||||||
2666438|NCT01523886|Secondary|Pain|Pain (shoulder, incision, deep abdominal and general) as the area under the curve from preoperatively to 7 days after surgery.|Preoperatively to 7 days after surgery|||||||
2666439|NCT01523886|Secondary|Surgical Space Conditions|The surgical space conditions during dissection of the gallbladder (4-stage scale and VAS 0-100).|During dissection of the gallbladder|||||||
2666440|NCT01523886|Secondary|Surgical Space Conditions|The average surgical space conditions (VAS 0-100 and 4-stage scale) during the procedure.|From surgical incision to last suture has been placed, an expected average of 30 minutes.|||||||
2666442|NCT01523886|Primary|The Percentage of Patients With Optimal Surgical Space Conditions ( 1 at a 4-step Scale) Assessed at the Time During Surgery, When View Was Less|"The surgical space conditions (4-stage scale) assessed at the time during surgery, when view was less. The laparoscopies were performed by experienced surgeons, whom were asked to evaluate surgical space conditions with a 4-point scale : Grade 1 (optimal) = optimal surgical space conditions; Grade 2 (good) = non-optimal conditions, but an intervention was not considered; Grade 3 (acceptable) = an intervention was considered in order to improve surgical space; Grade 4 (poor) = inadequate conditions and an intervention was necessary in order to ensure acceptable surgical space."|From surgical incision to last suture has been placed, an expected average of 30 minutes||||percentage of patients|||Number
2666443|NCT01523873|Secondary|Diagnostic Quality|"Diagnostic quality was assessed by the radiologist by answering the question could you come to a diagnostic ? (answer : yes or no)."|Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour)|Data were missing for 308 patients.|||participants|||Number
2666444|NCT01523873|Secondary|Image Quality|Image quality was assessed by the radiologist using a scale with five classes: very poor, poor, fair, good and very good.|Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour)|Data were missing for 164 patients.|||participants|||Number
2666445|NCT01523873|Secondary|Nephrogenic Systemic Fibrosis Incidence|For any patient identified with moderate to severe impaired renal function at the time of inclusion, a specific safety follow-up was performed in order to detect any suspicion of Nephrogenic Systemic Fibrosis.|Follow-up of at least 3 months after magnetic resonance examination|Patients of the Safety Population with moderate to severe impaired renal function.|||participants|||Number
2666446|NCT01523873|Primary|Frequency of Adverse Events|Adverse Events were notified and described.|During the time of usual follow-up post Dotarem administration (from less than 30 min to 1 hour after magnetic resonance examination).||||Adverse Events|||Number
2666447|NCT01523834|Secondary|Overall Survival (OS)|OS is defined as the time from enrolment to death from any case|36 months|Adult patients with diffuse large B-cell lymphoma relapsed/refractory after high-dose chemotherapy with autologous stem cell transfusion (ASCT) or not eligible for ASCT|||months||95% Confidence Interval|Median
2666448|NCT01523834|Secondary|Progression Free Survival (PFS)|PFS is defined as the time from enrolment to disease progression or relapse or death from any cause|36 months|Adult patients with diffuse large B-cell lymphoma relapsed/refractory after high-dose chemotherapy with autologous stem cell transfusion (ASCT) or not eligible for ASCT|||months||95% Confidence Interval|Median
2666449|NCT01523834|Secondary|Time to Response (TTR)|TTR is defined as the time from enrolment to Overall Response|36 months|Adult patients with diffuse large B-cell lymphoma relapsed/refractory after high-dose chemotherapy with autologous stem cell transfusion (ASCT) or not eligible for ASCT|||months||Full Range|Median
2666450|NCT01523834|Secondary|Complete Response (CR) Rate|Proportion of CR at the end of the induction phase according to the Cheson 1999 response criteria|6 months|Adult patients with diffuse large B-cell lymphoma relapsed/refractory after high-dose chemotherapy with autologous stem cell transfusion (ASCT) or not eligible for ASCT|||percentage of participants||95% Confidence Interval|Number
2666451|NCT01523834|Primary|Overall Response Rate (ORR) at the End of the Induction Phase|ORR is defined as the proportion of patients achieving a Complete Response (CR) or Partial Response (PR) according to the Cheson 1999 response criteria|6 months|Adult patients with diffuse large B-cell lymphoma relapsed/refractory after high-dose chemotherapy with autologous stem cell transfusion (ASCT) or not eligible for ASCT.|||percentage of participants||95% Confidence Interval|Number
2666452|NCT01523821|Secondary|Number (Percentage) of Patients at Each Dosing Cohort With Progression of GVHD|GVHD responses were assessed using criteria established by the Center for International Blood and Marrow Transplant Research and criteria from the Acute GVHD Activity Index. Patients who required additional systemic GVHD treatment beyond AAT before study day 28 were defined as having progressive GVHD.|GVHD responses were assessed on day 28 after starting AAT therapy or at time of death if patient died before study day 28.||||Participants|||Count of Participants
2666453|NCT01523821|Secondary|Number (Percentage) of Patients at Each Dosing Cohort With Occurrence of Infections|Infections were assessed using NCI CTCAE v4.0.|Infections were reported through 15 days after the last dose of AAT.||||Participants|||Count of Participants
2666454|NCT01523821|Secondary|Number (Percentage) of Patients at Each Dosing Cohort Who Experience One or More Thrombotic or Thrombo-embolic Events|Events were assessed using the NCI CTCAE v4.0.|Events were reported through 15 days after the last dose of AAT.||||Participants|||Count of Participants
2666455|NCT01523821|Secondary|Number (Percentage) of Patients at Each Dosing Cohort Who Experience One or More Suspected Serious Adverse Reactions (Infusion Related Reactions)|Serious adverse reactions were assessed by the NCI CTCAE v4.0.|Within 48 hours after each infusion||||Participants|||Count of Participants
2666456|NCT01523821|Secondary|Number (Percentage) of Patients at Each Dosing Cohort Experiencing an Unexpected Serious Adverse Event (SAE)|"Serious adverse events included death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/ incapacity, or congenital anomaly/birth defect. Significant events that do not meet these criteria may be considered serious if they jeopardize the patient and require a medical intervention to prevent one of the outcomes above. An unexpected adverse event is defined as an event that is not identified in nature, severity or frequency in the current investigator brochure/package insert/product information."|SAEs were reported through 30 days after the last dose of alpha 1 anti-trypsin (AAT).||||Participants|||Count of Participants
2666473|NCT01523743|Primary|Quality of Life (0-100 Point)|Difference in intermittent self-catheterisation quality of life measure, comparing compact versus standard urinary intermittent catheters The range of the scale is 0-100 where a high score indicating a high level of Quality of Life.|6 weeks|The primary analysis was based on the ITT population which included 118 subjects. 7 subjects were excluded from the ITT population. They were excluded because they discontniued the investigation and only baseline data was collected from them. Furthermore, not all subjects in the ITT population answered the QoL questionaire for both products.|||units on a scale||Standard Deviation|Mean
2668604|NCT01504854|Secondary|Comparison of the Response to Treatment of Resveratrol Based on ApoE Genotype|CSF Abeta40|Week 52|ITT analyses. Total population and subpopulation of ApoE4 non-carriers.|||ng/ml||Standard Deviation|Mean
2666457|NCT01523821|Primary|Number (Percentage) of Patients at Each Dosing Cohort Who Experience no Toxicity and in Whom Graft Versus Host Disease (GVHD) is Stable or Improved|Toxicity and adverse events were assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All adverse events were reported regardless of attribution to alpha 1 anti-trypsin (AAT). GVHD response was defined per standard criteria for improvement, no change or progression of signs/symptoms in skin rash (% body surface area), GI (nausea, vomiting, anorexia, diarrhea, GI bleeding, abdominal cramping) and hepatic function (serum bilirubin levels). For this outcome measure, the requirement for additional GVHD treatment beyond AAT was not included in the criteria for response (i.e patients who may have required additional GVHD treatment before study day 28 were not automatically categorized as non-responders or as having progressive GVHD).|Adverse events were reported through 15 days after the last dose of AAT. GVHD response assessed at study day 28.||||Participants|||Count of Participants
2666458|NCT01523782|Secondary|Number of Participants With Complete Remission (CR) Rate Following Induction 1 and Induction 2|"CR was defined using:~Clinical criteria: disappearance of clinical signs of acute lymphocytic leukemia (ALL)~Blood criteria: neutrophils > 1 G/L and platelets >100 G/L~Medullary criteria: normally rich bone marrow and percentage of blasts <5%"|1 and 2 months|28 patients were analyzed for CR after Induction 1 (2 pts in 50 IU/kg; 13 pts in 100 IU/kg; 13 pts in 150 IU/kg). 22 patients were analyzed for CR after Induction 2 (2 pts in 50 IU/kg; 11 pts in 100 IU/kg; 9 pts in 150 IU/kg).|||Participants|||Count of Participants
2666459|NCT01523782|Secondary|Number of Patients Positive for Anti-L-asparaginase Antibodies|Evaluation of the number of patients testing positive for anti-asparaginase antibodies.|Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||Participants|||Count of Participants
2666460|NCT01523782|Secondary|Summary of Encapsulated Asparaginase (U/L) Over Time||Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||U/L||Standard Deviation|Mean
2666461|NCT01523782|Secondary|Summary of Free Asparaginase Over Time||Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||U/L||Standard Deviation|Mean
2666462|NCT01523782|Secondary|Cerebral Spinal Fluid Concentrations of Glutamic Acid|Mean cerebral spinal fluid glutamic acid concentration|Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||μmol/L||Standard Deviation|Mean
2666463|NCT01523782|Secondary|Cerebral Spinal Fluid Concentrations of Glutamine|Mean cerebral spinal fluid glutamine concentration|Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||μmol/L||Standard Deviation|Mean
2666464|NCT01523782|Secondary|Cerebral Spinal Fluid Concentrations of Aspartic Acid|Mean cerebral spinal fluid aspartic acid concentration|Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||μmol/L||Standard Deviation|Mean
2666465|NCT01523782|Secondary|Cerebral Spinal Fluid Concentrations of Asparagine|Mean cerebral spinal fluid asparagine concentration over time.|Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||μmol/L||Standard Deviation|Mean
2666466|NCT01523782|Secondary|Plasma Concentrations of Glutamic Acid.|Mean glutamic acid concentration over time.|Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||μmol/L||Standard Deviation|Mean
2666467|NCT01523782|Secondary|Plasma Concentrations of Glutamine|Mean glutamine concentration over time.|Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||μmol/L||Standard Deviation|Mean
2666468|NCT01523782|Secondary|Plasma Concentrations of Aspartic Acid|Mean plasma concentration of aspartic acid over time.|Induction 1 and Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||μmol/L||Standard Deviation|Mean
2666469|NCT01523782|Secondary|Plasma Concentrations of Asparagine|Mean plasma concentration of asparagine over time. Participants who were Below the Lower Limit of Quantification (BLLQ) were assigned a value of 0.51 μmol/L.|Induction 1 & Induction 2|The participant numbers in some of the rows below differ from the overall participant numbers analyzed because we are missing the values from some of those time points.|||μmol/L||Standard Deviation|Mean
2666470|NCT01523782|Secondary|Safety Endpoint - DLTs Assessed During Induction 1 and Induction 2|"Safety: Toxicity, assessed during Induction 1 and Induction 2: according to NCI-CTCAE v3.0 August 2006, with Dose Limiting Toxicities (DLT) defined as: Grade 2, 3, 4 of pancreatic toxicity, Grade 3 or 4 hepatic toxicity, allergic toxicity or deep cerebral thrombosis, known as potentially related to L-asparaginase; hematological toxicity defined as bone marrow blast free aplasia, 30 days following the last injection of chemotherapy, all other Grade 4 toxicities.~Information in a previous submission of this record indicated that Number of Participants with DLTs was included as a Secondary Outcome Measure, however only the number of DLTs is a pre-specified Secondary Outcome Measure."|Induction 1 and Induction 2|22 total DLTs occurred.|||DLTs|||Number
2666471|NCT01523782|Primary|Efficacy Primary Endpoint - Percentage of Patients Responding to Treatment|The main evaluation criterion is a composite efficacy/toxicity criterion. Efficacy, assessed during induction 1: percentage of patients responding to treatment, i.e. with plasma Asn concentration ≤2µM (depleted), for a duration of at least 7 days after the administration of GRASPA®|7 days after the first administration of GRASPA® during Induction 1||||Participants|||Count of Participants
2666472|NCT01523756|Primary|Leakage Under the Base Plate Using a 24-point Scale|Leakage under the baseplate was measured with a 24 point scale where 0 points represents no leakage (best possible out come) and 24 points represents leakage on the whole plate (worst possible outcome)|Each product will be tested 2 weeks||||units on a scale|Participants|Standard Deviation|Mean
2666474|NCT01523613|Secondary|Restored Tooth Performance|"Cut-off: Restored tooth failure (tooth in need of repair or management) as determined by Tooth integrity (enamel/tooth fracture), Sensitivity and Vitality assessment within both arms.~Clinically successful is defined as: No need for repair or management due to sensitivity or loss of tooth integrity or vitality."|2 years|"21 Subjects with 2 paired restorations (21 R, 21 F).~48 Subjects with a single restoration (23 R, 25 F)."|||Restored tooth|Restored tooth||Count of Units
2666475|NCT01523613|Secondary|Caries Incidence Associated With Restoration|"- Caries free restorations is defined as: free of caries associated with restoration."|2 years|"21 Subjects with 2 paired restorations (21 R, 21 F).~48 Subjects with a single restoration (23 R, 25 F).~In Total: 69 subjects, 90 restorations."|||Restoration|Restoration||Count of Units
2666476|NCT01523613|Primary|Survival Rate|"Cut-off: Restoration failure as determined by (need for) replacement due to fracture and retention losses within both arms.~Clinically successful is defined as: no need for replacement due to fracture or retention losses."|2 years|"21 Subjects with 2 paired restorations (21 R, 21 F).~48 Subjects with a single restoration (23 R, 25 F).~Recall total: 69 subjects, 90 restorations.~No retention losses: all restorations (both R and F) in-situ and bonded; no exposed dentin."|||Restorations|Restorations||Count of Units
2666477|NCT01523587|Secondary|Change in Score Over Time in Coughing,Dyspnoea and Pain|"Health related quality of life (HRQoL) was measured with the following multi dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of change in score over time, adjusted for baseline score and race.~Questionnaires have items relating to Cough, Dyspnoea and Pain. Overall Scores are transformed to a standardised scale of 0 to 100 with the larger value indicating a worse outcome. A change of (+/-) 10 points is considered to be relevant.~The change in cough, dyspnea and pain will be assessed using a mixed effects growth curve model with the average profile over time for each endpoint described by a piecewise linear model (presented as post baseline in data table). Post−baseline mean is adjusted for baseline and race."|From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).|RS|||Units on a scale||Standard Error|Least Squares Mean
2666478|NCT01523587|Secondary|Summary of Time to Deterioration in Coughing, Dyspnoea and Pain.|Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: Time to deterioration.|From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).|RS|||Months||95% Confidence Interval|Median
2666479|NCT01523587|Secondary|Number of Participants With Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire|Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the european organization for research and treatment of cancer (eortc) quality of life questionnaire (QLQ-C30) questionnaire and its lung cancer specific supplementary module EORTC QLQ-LC13 and the EQ-5D health status self-assessment questionnaire. The questionnaires were assessed at the first visit of each treatment course, at end of treatment (EOT) and follow up prior to clinical assessment. The results displayed show number of patients with improvement in the relevant criteria. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: The number of patients that were improved: Change in cough; dyspnoea and pain scores over time.|From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).|RS|||Participants|||Number
2666480|NCT01523587|Secondary|Tumour Shrinkage|"Maximum percentage decrease from baseline in the sum of target lesion diameters following independent review. The change in the size (i.e. the sum of diameters (SOD)) of target lesions from baseline was derived. Tumour shrinkage for each patient was measured (based on Independent Radiologic Review (IRR)) as the minimum SOD of target lesions after randomisation.~A negative percentage indicates decrease from baseline; positive numbers indicate an increase of tumour size. The mean maximum decrease from baseline of +5 and +9.4 reflect an average increase in tumour size.~Post−baseline mean is adjusted for baseline sum of diameters and race."|First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).|Patients from the randomised set with tumour assessments are considered for the analysis of this endpoint.|||Millimeter (mm)||Standard Error|Least Squares Mean
2666481|NCT01523587|Secondary|Number of Participants With Disease Control According to RECIST 1.1|Disease control was assessed based on Independent Radiologic Review (IRR) and investigator assessment. A patient with a best overall response of CR, PR, or Stable Disease (SD) was considered to have disease control. Patients with no baseline target lesions who had no evidence of disease progression in their non-target lesions and had no new lesions were considered to have disease control. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).|RS|||Participants|||Number
2666482|NCT01523587|Secondary|Number of Participants With Objective Response According to RECIST 1.1|A patient with a best overall response of Complete Responder (CR) or Partial Responder (PR) was considered to show objective response to study medication. For patients with an objective response, time to objective response was defined as the time from randomization to the first objective response; duration of objective response was defined as the time from the first objective response to progression (or death if the patient died before progression). Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).|RS|||Participants|||Number
2666483|NCT01523587|Secondary|Overall Survival|Overall Survival is defined as the time from randomisation to death. It was a key secondary endpoint.|From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).|RS|||Months||95% Confidence Interval|Median
2666539|NCT01522755|Primary|Pacing Threshold During and Post Implant of the CapsureFix MRI Lead Model 5086|Change of pacing threshold will be measured during and post implant of the CapsureFix MRI lead model 5086|3 months|409 patients have been consecutively enrolled in 32 sites.|||Volt||Standard Deviation|Mean
2666484|NCT01523587|Primary|Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1|"Progression Free Survival (PFS) was defined as the time from randomization to disease progression (or death if the patient died before progression) by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize) or worsen (progress) during treatment. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).|Randomized Set (RS): All patients who were randomized, regardless of whether they received investigational treatment.|||Months||95% Confidence Interval|Median
2666485|NCT01523496|Secondary|Changes in Vitamin D Binding Protein (VDBP)|Evaluate the dose-related efficacy of vitamin D binding Protein in levels in the blood in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral vitamin D supplementation.|6 months|HIV-infected children and young adults and matched healthy control group. Results were not analyzed were captured comparing HIV+ young adults on control or supplementation vit D to HIV - controls|||ng/mL||Inter-Quartile Range|Median
2666486|NCT01523496|Primary|Changes in Serum 25(OH)D3 Levels|Evaluate the dose-related efficacy of correction of Vitamin D deficiency for 25(OH)D3 levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral Vitamin D supplementation: control dose (18,000 IU per month) or supplemented dose (medium 60,000IU per month or high dose 120,000IU/month )|6 months|HIV-infected on vitamin D control or supplementation dose and matched HIV-uninfected group on control or supplementation dose|||ng/mL||Inter-Quartile Range|Median
2666487|NCT01523457|Secondary|Correlate Time to Progression, Objective Response, and Overall Survival With Early Changes in Glucose Metabolism Using FDG-positron Emission Tomography (PET) Scanning|The time to progression, objective response rate, and overall survival will be correlated with early changes in glucose metabolism using FDG-positron emission tomography (PET) scanning in patients with metastatic disease and locally advanced disease.|24 weeks|This outcome was included in the 2012 protocol registration and actually describes a series of analyses that were not fully conducted, and will not be. The outcome measures described in the outcome description are presented as separated outcome measures elsewhere in this results record.||||||
2666488|NCT01523457|Secondary|Rate of Resection in Patients With Locally Advanced Disease|The rate of surgical resection in the cohort of patients with locally advanced disease will be determined.|24 weeks|Only LAPC patients were considered in the analysis. 13 patients in the LAPC group had surgical resection. The definition of locally unresectable and borderline were clarified in the protocol.|||participants|||Number
2666489|NCT01523457|Secondary|Toxicity|Toxicities will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0. Rates of grade 3 and 4 toxicities will be compared to historical controls. MPC and LAPC are combined because they were given the exact same medication. The study aimed to compare this dosage with historical dosage, so this comparison is the most appropriate.|24 weeks|One of the total 75 patients did not receive treatment and was excluded from toxicity analysis. Treatment-related grade 3 and 4 adverse events observed in our study and in the historical control group treated with standard FOLFIRINOX.|||participants|||Number
2666490|NCT01523457|Secondary|Overall Survival|Overall survival will be determined in patients with metastatic disease and in patients with locally advanced disease.|24 weeks|Two of 31 patients with LAPC were excluded from efficacy analysis because they did not complete four cycles to reach the first efficacy assessment (one due to cholecystitis with abscess and one due to cerebrovascular accident).|||percentage of participants|||Number
2666491|NCT01523457|Secondary|Objective Response Rate|Response will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1 by independent radiology review) at 8 week intervals in patients with metastatic disease and in patients with locally advanced disease.|24 weeks|Two of 31 patients with LAPC were excluded from efficacy analysis because they did not complete four cycles to reach the first efficacy assessment (one due to cholecystitis with abscess and one due to cerebrovascular accident).|||percentage of participants|||Number
2666492|NCT01523457|Primary|Progression Free Survival|The primary objective of this study is to determine the progression free survival in patients with metastatic pancreatic cancer and in patients with locally advanced unresectable non-metastatic pancreatic cancer treated with a dose-attenuated modification of FOLFIRINOX. Tumour response was determined according to RECIST 1.1 by independent radiology review.|24 weeks|Two of 31 patients with LAPC were excluded from efficacy analysis because they did not complete four cycles to reach the first efficacy assessment (one due to cholecystitis with abscess and one due to cerebrovascular accident).|||percentage of participants|||Number
2666493|NCT01523392|Secondary|AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses|The standard deviation (SD) is the geometric SD|Predose, 0.5 hour, 2 hours, 8 hours from loading dose and 0, 2 hours, 8 hours and 12 hours from last dose|Pharmacokinetic (PK) Analysis Set - included all patients for whom at least one valid PK reading was available|||ng/mL||Standard Deviation|Geometric Mean
2666494|NCT01523392|Secondary|Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses|The standard deviation (SD) is the geometric SD|Predose, 0.5 hour, 2 hours, 8 hours from loading dose; 0, 2 hours, 8 hours and 12 hours from last dose|Pharmacokinetic (PK) Analysis Set - included all patients for whom at least one valid PK reading was available|||ng/mL||Standard Deviation|Geometric Mean
2666495|NCT01523392|Secondary|Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 Hours and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8||At 2 hours and 8 hours on Day 7 after multiple doses and at end of dosing interval on Day 8|PD Analysis Set|||PRU||95% Confidence Interval|Least Squares Mean
2666496|NCT01523392|Secondary|Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 Hour and 8 Hours After Loading Dose||At 0.5 hour and 8 hours after the loading dose|PD Analysis Set|||PRU||95% Confidence Interval|Least Squares Mean
2666540|NCT01522755|Primary|Lead Stability|Lead stability of the Capsure Fix as measured by number of dislodgments|3 months||||dislodgements|||Number
2666497|NCT01523392|Primary|Inhibition of the P2Y12 Receptor as Measured by Platelet Reaction Unit (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose||At 2 hours after the loading dose|Pharmacodynamic (PD) Analysis Set (N=32) - included all participants for whom PD data was available with no major protocol deviations thought to significantly affect the PD of ticagrelor or clopidogrel|||PRU||95% Confidence Interval|Least Squares Mean
2666498|NCT01523366|Secondary|AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses|The SD is a statistic using the log-transformed data and is not the geometric SD.|Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose|PK Analysis Set|||ng/mL||Standard Deviation|Geometric Mean
2666499|NCT01523366|Secondary|Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses|The standard deviation (SD) is a statistic using the log-transformed data and is not the geometric SD.|Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose|Pharmacokinetic (PK) Analysis Set, defined as all participants for whom at least one valid PK reading was available|||ng/mL||Standard Deviation|Geometric Mean
2666500|NCT01523366|Secondary|Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8|The end of dosing interval was approximately 12 hours after the last evening dose of ticagrelor and approximately 24 hours after the last morning dose of clopidogrel. Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value|At 2 hours and 8 hours on Day 7 after multiple doses, and at the end of dosing interval on Day 8|PD Analysis Set|||PRU||95% Confidence Interval|Least Squares Mean
2666501|NCT01523366|Secondary|Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose|Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value|At 0.5 and 8 hours after the loading dose|PD Analysis Set|||PRU||95% Confidence Interval|Least Squares Mean
2666502|NCT01523366|Primary|Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose|Participants with low (<150) baseline PRU values (indicating an incomplete washout from anti-platelet therapy) were excluded during the period corresponding to the low baseline value|At 2 hours after the loading dose|Pharmacodynamic (PD) Analysis Set|||PRU||95% Confidence Interval|Least Squares Mean
2666503|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Snaith-Hamilton Pleasure Scale (SHAPS)|The SHAPS is a self-report instrument developed for the assessment of hedonic capacity. The sum of the 14 items scores ranges from 0 to 14. A higher score represents more anhedonic symptoms.|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.|||units on a scale||95% Confidence Interval|Least Squares Mean
2666504|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Apathy Scale (AS)|The AS is an abbreviated version of the Apathy Scale (AS). The AS consists of 14 items phrased as questions that are to be answered on a four-point Likert scale. It was developed specifically for patients with Parkinson Disease (PD). For questions 1-8, the scoring system is the following: not at all = 3 points; slightly = 2 points; some =1 point, a lot = 0 point. For questions 9-14: the scoring system is the following: not at all = 0 points; slightly = 1 point; some = 2 points; a lot = 3 points. Adding all scores provides the final score with a range from 0 to 42.|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.|||units on a scale||95% Confidence Interval|Least Squares Mean
2666505|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Combined Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (ADL) Plus Part III (Motor Subscale)|The combined score of UPDRS part II and UPDRS part III is the sum of the individual scores and threfore ranges from 0 (normal) to 160 (severe).|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.|||units on a scale||95% Confidence Interval|Least Squares Mean
2666506|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Subscale)|Improvement of motor symptoms is measured by the change from Baseline in UPDRS Part III motor score. The UPDRS Part III is an accepted and validated scale for the assessment of motor function in Parkinson's disease. Each of the elements in the UPDRS Part III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total score of UPDRS part III ranges from 0 (normal) to 108 (severe abnormalities).|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.|||units on a scale||95% Confidence Interval|Least Squares Mean
2666507|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living-ADL Subscale)|The UPDRS Part II is a tool to measure Activities in Daily Living - it includes speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting clothes, falling (unrelated to freezing), freezing when walking, walking, tremor, and sensory complaints related to Parkinsonism. Each of the 13 questions is measured on a scale from 0 (normal) to 4 (severe). The total score of UPDRS part II ranges from 0 (normal) to 52 (severe).|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.|||units on a scale||95% Confidence Interval|Least Squares Mean
2666508|NCT01523301|Secondary|Change From Baseline to the End of Maintenance Period in the Score of Beck Depression Inventory (BDI-II)|The Beck Depression Inventory II (BDI-II) is a self-report instrument to measure Depression symptoms and severity. There are 21 items in the BDI-II. Scores of 0-13 are considered minimal depression; 14-19 indicates mild depression; 20-28 indicates moderate depression; and 29-63 indicates severe depression.|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.|||units on a scale||95% Confidence Interval|Least Squares Mean
2666509|NCT01523301|Primary|Change From Baseline to the End of Maintenance Period in the Score of the Hamilton Depression Scale (HAM-D)|The HAM-D consists of 17 items. Nine of the items are scored on a 5-point scale, ranging from 0 to 4. The remaining 8 items are scored on a 3-point scale, from 0 to 2. Therefore, the total score ranges between 0 to 52, with a cutoff score of 15/16 diagnosing major depressive disorder.|From Baseline (Week 0) to end of Maintenance Period (up to Week 15)|Efficacy Evaluable Set (EES) consisted of all subjects from the Full Analysis Set (FAS) with a baseline total HAM-D score of 12 or larger.|||units on a scale||95% Confidence Interval|Least Squares Mean
2666510|NCT01523275|Secondary|Peak Inspiratory Flow Measurement|Change in maximum inspiratory air flow from preoperative value to highest postoperative value within 3 months of surgery. Calculation details: Highest postoperative value within 3 months of surgery minus preoperative value.|3 months|Improvement in peak inspiratory flow (PIF) was calculated for each surgery performed during the study with available PIF data|||Liters per second|Surgeries|Standard Deviation|Mean
2666511|NCT01523275|Secondary|Duration of Symptom Improvement|Symptom improvement was measured using the Clinical COPD Questionnaire, a 10-point patient reported symptom score. Duration of symptom improvement was defined as the time from surgery to the time that symptoms to worsened beyond a CCQ score of 1 or the time to the subsequent surgery if CCQ never exceeded 1|24 months|Time to symptom score (CCQ) progression was calculated for each surgery performed during the study with available CCQ data.|||Months|Surgeries|Standard Deviation|Mean
2666512|NCT01523275|Primary|Time to Repeat Surgery|Length of time between surgeries for laryngotracheal stenosis during the study|24 months|Patients who did not undergo a subsequent surgery after the initial study surgery were excluded as a surgical interval could not be calculated. There were two patients in each arm that did not have subsequent surgeries|||Months||Standard Deviation|Mean
2666513|NCT01522976|Secondary|Toxicity Rate|Adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 5 years|Analysis includes only eligible patients who also received treatment.|||Participants|||Number
2666514|NCT01522976|Secondary|Pre-study Cytogenetic Abnormalities|Cytogenetic risk group is used to identify cytogenetic abnormalities.|Up to 5 years|Analysis includes eligible patients only.|||participants|||Number
2666515|NCT01522976|Secondary|Overall Survival|OS is calculated for all patients from the date of initial registration to date of death due to any cause. The follow- up for patients last known to be alive is censored at the date of last contact. OS will be estimated for each of the three arms using the Kaplan-Meier method.|Up to 5 years|Analysis includes eligible patients only.|||Days||95% Confidence Interval|Median
2666516|NCT01522976|Secondary|Relapse-free Survival|RFS is calculated for patients who have achieved a response. RFS will be measured from the date of response to the date of first documentation of relapse from response (as defined in the primary objective), or death due to any cause. The follow-up for patients last known to be alive and without report of relapse is censored at the date of last contact. RFS will be estimated for each of the three arms using the Kaplan-Meier method.|Up to 5 years|Analysis includes eligible patients who had a response.|||Days||95% Confidence Interval|Median
2666517|NCT01522976|Primary|Overall Survival (Phase III)|OS is calculated for all patients from the date of initial registration to date of death due to any cause. The follow-up for patients last known to be alive is censored at the date of last contact. Stratified Cox regression models will be used to compare OS of the combination arm selected in the Phase II portion of the trial to OS of the single-agent azacitidine arm.|Up to 5 years|This trial did not proceed to the Phase III portion. Therefore, no patients were analyzed for this outcome measure.||||||
2666518|NCT01522976|Primary|Response Rate (Phase II)|A response is any of complete hematological remission, partial remission, or hematologic improvement.|Up to 5 years|Analysis includes eligible patients only.|||percentage of patients having a response||95% Confidence Interval|Number
2666519|NCT01522963|Primary|Nicotine Withdrawal Symptoms|The difference between lozenge use at the designated time-point prior to the stress task and lozenge use in withdrawal symptom response as measured by the Minnesota Nicotine Withdrawal Scale (MNWS) that occurs when smokers are exposed to a stressful task. The possible range of scores for the MNWS is between 0 and 28 with higher scores indicated greater withdrawal symptom severity.|5 to 35 minutes||||units on a scale||95% Confidence Interval|Least Squares Mean
2666520|NCT01522963|Primary|Craving|The difference between lozenge use at the designated time-point prior to the stress task and lozenge use after the stress task in craving response (measured by factor 1 of the Questionnaire on Smoking Urges) that occurs when smokers are exposed to a stressful task. The possible range of scores was between 5 and 35 with higher scores indicated greater smoking urges.|Baseline, 6 months||||units on a scale||95% Confidence Interval|Least Squares Mean
2666521|NCT01522950|Secondary|Change in Diastolic Blood Pressure|Change in diastolic blood pressure as measured by sphygmomanometer from baseline to 9 months after intervention initiation.|baseline, 9 months||||mmHg||Standard Deviation|Mean
2666522|NCT01522950|Secondary|Change in Systolic Blood Pressure|Change in systolic blood pressure as measured by sphygmomanometer from baseline to 9 months after intervention initiation.|baseline, 9 months||||mmHg||Standard Deviation|Mean
2666523|NCT01522950|Secondary|Change in Large Artery Elasticity|Change in large artery elasticity (a marker for endothelial function) from baseline to 9 months after intervention initiation.|baseline, 9 months||||(ml/mmHg × 10)||Standard Deviation|Mean
2666524|NCT01522950|Primary|Change in Small Artery Elasticity|Change in small artery elasticity (a marker for endothelial function) from baseline to 9 months after intervention initiation.|baseline, 9 months||||(ml/mmHg × 100)||Standard Deviation|Mean
2666525|NCT01522937|Secondary|The Number of Patients That Experience Grade 4+ Gastrointestinal Bleeding|Grade 4 toxicities are life threatening toxicities that require urgent attention.|1 Year||||patients|||Number
2666526|NCT01522937|Secondary|The Number of Patients Who Experience Grade 4+ Hepatotoxicity|Grade 4 toxicities are life threatening toxicities that require urgent attention.|1 Year||||patients|||Number
2666527|NCT01522937|Secondary|The Percentage of Patients Alive at 1 Year||1 Year||||percentage of patients||95% Confidence Interval|Number
2666528|NCT01522937|Secondary|The Percentage of Patients Alive Without Progression at 1 Year|Progression is defined as a greater than or equal to 20% growth of a lesion from the smallest lesion measurement|1 Year||||percentage of patients||95% Confidence Interval|Number
2666530|NCT01522924|Primary|Change From Baseline in Tobacco Cessation Knowledge Score|The tobacco cessation knowledge variable was computed by adding the participants' total number of correct answers of the ten knowledge questions. The rating scale was: 0 = incorrect and 1 = correct. A higher value represents participants' higher level of tobacco cessation treatment knowledge (Range: 0-10). The difference in the tobacco cessation knowledge from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of participants' correct answers at Questionnaire 1 from the total number of participants' correct answers at Questionnaire 2.|Questionnaire 1 (pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)||||units on a scale||Standard Deviation|Mean
2666531|NCT01522924|Primary|Change From Baseline in Intentions Score|Participants' intentions to provide tobacco cessation treatment were computed by adding values from thirteen questions to assess dental students' intent to counsel patients to quit tobacco use. The rating scale was: 0 = never, 1 = rarely, 2 = sometimes, 3 = almost always, 4 = always (every visit). A higher value represents participants' stronger intentions to provide tobacco cessation treatment (Range: 0-52). The difference in participants' intentions to provide tobacco cessation treatment from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of participants' intentions at Questionnaire 1 from the total value of participants' intentions at Questionnaire 2.|Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)||||units on a scale||Standard Deviation|Mean
2666532|NCT01522924|Primary|Change From Baseline in Self-efficacy Score|Self-efficacy represents an individual's confidence in his/her ability to perform a behavior. The self-efficacy variable was computed by adding the values of ten questions to assess the participants' self-efficacy to counsel patients to quit tobacco use. The rating scale was: 0 = not at all confident, 1 = not very confident, 2 = moderately confident, 3 = very confident, and 4 = extremely confident. A higher value represents participants' higher level of confidence in providing tobacco cessation treatment (Range: 0-40). The difference in participants' self-efficacy from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of self-efficacy at Questionnaire 1 from the total value at Questionnaire 2.|Questionaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)||||units on a scale||Standard Deviation|Mean
2666533|NCT01522924|Primary|Change From Baseline in Perceived Skills Score|The perceived skills variable was computed by adding the values of seven questions that assessed the participants' perceived level of tobacco cessation treatment skills from poor to excellent. The rating scale was: 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent. A higher value represents a higher level of tobacco cessation treatment skills perceived by participants (Range: 0-28). The difference in the participants' perceived skills from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of perceived skills at Questionnaire 1 from the total value of perceived skills at Questionnaire 2.|Questionnaire 1(baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)||||units on a scale||Standard Deviation|Mean
2666534|NCT01522924|Primary|Change From Baseline in Subjective Norms Score|Subjective norms are beliefs that people who influence your actions approve or disapprove of the behavior. The subjective norms variable was computed by adding the values of six questions to assess the participants' level of perceived social pressures to counsel patients in quitting tobacco use. Questions wer rated on a seven-point Likert scale; higher point values indicate a perceived social norm more supportive of counseling patients in quitting tobacco use(Range: 0-36). The difference in the subjective norms score from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of participants' subjective norms at Questionnaire 1 from the total number of participants' subjective norms at Questionnaire 2.|Questionnaire 1 ( baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)|The number of participants for analysis was determined by the completing the questionnaire after the lecture or after the counseling practice sessions using standardized patients.|||units on a scale||Standard Deviation|Mean
2666535|NCT01522924|Primary|Change From Baseline in Perceived Barriers Score|The perceived barriers variable was computed by adding the total number of barriers reported by participants. Participants were asked to select all factors that may limit their ability to counsel tobacco users during every visit. The rating scale for reporting barriers was: 0 = no and 1 = yes. A higher value represents a higher number of barriers to providing tobacco cessation treatment reported by participants(Range: 0-11). The difference in perceived barriers from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total number of perceived barriers at Questionnaire 1 from the total number of perceived barriers at Questionnaire 2.|Questionnaire 1(baseline/pre-lecture) to Questionnaire 2(post-lecture or post-lecture and counseling /debriefing sessions)|The number of participants for analysis was determined by completing the second questionnaire after the lecture or after the counseling practice sessions using standardized patients.|||units on a scale||Standard Deviation|Mean
2666536|NCT01522924|Primary|Change From Baseline in Attitude Score|"The attitude variable was computed by adding the values from two questionnaire items to assess the level agreement with statements: 1.) It is important for members of the profession to discuss tobacco use with patients and 2.) A brief intervention (3 minutes) for tobacco cessation with my patients would be effective. The rating scale was: 0 = strongly disagree, 1 = moderately disagree, 2 = somewhat disagree, 3 = neither disagree or agree, 4 = somewhat agree, 5 = moderately agree, and 6 = strongly agree. A higher value represents participants' more positive attitude toward providing tobacco cessation treatment (Range:0-8). The difference in the attitude from Questionnaire 1 to Questionnaire 2 was computed by subtracting the total value of the variable at Questionnaire 1 from the total value at Questionnaire 2."|Questionnaire 1 (baseline/pre-lecture) to Questionnaire 2 (post-lecture or post-lecture and counseling/debriefing sessions)|The control group (lecture only) completed the second questionnaire after the lecture and the intervention group (counseling practice sessions) completed the second questionnaire after the counseling practice sessions and the debriefing session.|||units on a scale||Standard Deviation|Mean
2666537|NCT01522755|Primary|Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086|Change of impedance will be measured during and post implant of the CapsureFix MRI Lead Model 5086|3 months||||Ohm||Standard Deviation|Mean
2666538|NCT01522755|Primary|Sensing Amplitude During and Post Implant of the CapsureFix MRI Lead Model 5086|Change of sensing amplitude will be measured during and post implant of the CapsureFix MRI Lead Model 5086|3 months||||mV||Standard Deviation|Mean
2666541|NCT01522755|Primary|Ease of Implant|Ease of implant as experienced by the implanting physician on maneuverability of the catheter. This was measured by a questionnaire for which each criterion was coded as Very Good, Good, Fair, Poor, Very Poor. Coding 9, 7, 5, 3, 1 was applied for each response with 9 representing Very Good. An average was calculated for each evaluation and for each probe implantation site.|at implant||||score on a scale||Standard Deviation|Mean
2666542|NCT01522703|Primary|Exhaled Nitric Oxide Concentrations|exhaled nitric oxide concentrations|at 3 days||||ppb||Inter-Quartile Range|Median
2666543|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Overall Tolerability Preference Survey Results|Overall Tolerability Preference Survey Results at Day 22 (Safety Population) Grouped by Fitzpatrick Skin Type (FST). Data collected from available subjects on day 22. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin). One subject did not participate in the User Preference Survey; as a result, 1 subject was not included in the FST I - III group results below.|Day 22||||participants|||Number
2666544|NCT01522456|Post-Hoc|Fitzpatrick Skin Type User Preference Survey at Day 22|User Preference Survey at Day 22 (Safety Population) Grouped by Fitzpatrick Skin Type. Fitzpatrick skin type (FST) is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin). Two subjects did not participate in the User Preference Survey; as a result, 2 subjects were not included in the FST I - III group results below.|Day 22||||participants|||Number
2666545|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Stinging/Burning)|Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Stinging/Burning. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).|Day 1 - Day 22|Safety Population|||participants|||Number
2666546|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Dryness)|Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Dryness. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).|Day 1 - Day 22|Safety Population|||participants|||Number
2666547|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Scaling)|Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Scaling. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).|Day 1 - Day 22|Safety Population|||participants|||Number
2666548|NCT01522456|Post-Hoc|Fitzpatrick Skin Type Worst Postbaseline Tolerability Assessment (Erythema)|Worst Postbaseline Tolerability Assessment Grouped by Fitzpatrick Skin Type for Erythema. Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. Skin type 1 = always burns and never tans (light, pale skin) and skin type VI = never burns, tans very easily, and is deeply pigmented (black, very dark brown to black skin).|Day 1 - Day 22|Safety Population|||participants|||Number
2666549|NCT01522456|Other Pre-specified|Overall Tolerability Preference Survey|Overall tolerability preference survey taken by the subjects. Data collected from available subjects on day 22.|Day 22|Safety population|||participants|||Number
2666550|NCT01522456|Secondary|Cumulative Tolerability (Combined)|Cumulative tolerability assessments for erythema, scaling, dryness, and stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores for erythema, scaling, dryness, or stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population|||scores on a scale|||Number
2666551|NCT01522456|Secondary|Cumulative Tolerability (Stinging/Burning)|Cumulative tolerability assessments for stinging/burning. Cumulative tolerability is defined as the sum of the tolerability scores stinging/burning. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population|||scores on a scale|||Number
2666552|NCT01522456|Secondary|Cumulative Tolerability (Dryness)|Cumulative tolerability assessments for dryness. Cumulative tolerability is defined as the sum of the tolerability scores for dryness. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population|||scores on a scale|||Number
2666553|NCT01522456|Secondary|Cumulative Tolerability (Scaling)|Cumulative tolerability assessments for scaling. Cumulative tolerability is defined as the sum of the tolerability scores for scaling. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population|||scores on a scale|||Number
2666554|NCT01522456|Secondary|Cumulative Tolerability (Erythema)|Cumulative tolerability assessments for erythema. Cumulative tolerability is defined as the sum of the tolerability scores for erythema. Tolerability was assessed on a 4-point categorical scale(0=none, 1=mild, 2=moderate, 3=severe) for all subjects at each visit.|Day 1 - Day 22|Safety population|||scores on a scale|||Number
2666555|NCT01522456|Secondary|Tolerability at Day 22 (Stinging/Burning)|Tolerability assessments at day 22 for stinging/burning|Day 22|Safety population|||participants|||Number
2666556|NCT01522456|Primary|Worst Postbaseline Tolerability (Stinging/Burning)|Worst postbaseline tolerability assessments for stinging/burning|Day 1 - Day 22|Safety population|||participants|||Number
2666557|NCT01522456|Secondary|Tolerability at Day 22 (Scaling)|Tolerability assessments at day 22 for scaling|Day 22|Safety population|||participants|||Number
2666558|NCT01522456|Primary|Worst Postbaseline Tolerability (Dryness)|Worst postbaseline tolerability assessments for dryness.|Day 1 - Day 22|Safety population|||participants|||Number
2666559|NCT01522456|Primary|Worst Postbaseline Tolerability (Scaling)|Worst postbaseline assessment for scaling.|Day 1 - Day 22|Safety population|||participants|||Number
2666565|NCT01522443|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death (due to any cause). Participants that had not died were censored at last known date alive. The analyses for OS occurred after 78/196 deaths (40% of the total required for the pre-specified primary analysis of OS). The data cut-off date was 06 October 2014. Median OS was calculated using Kaplan-Meier estimates.|OS was measured at the time of randomization until 78 deaths|The Intent to Treat (ITT) population was used and included 119 randomized subjects (61 cabozantinib, 58 mitoxantrone plus prednisone) at the time of primary analysis (data cut off date: 06 October 2014).|||months||95% Confidence Interval|Median
2666566|NCT01522443|Secondary|Bone Scan Response (BSR)|BSR is defined as >=30% in the bone scan lesion area (BSLA) compared with baseline. Bones scans were evaluated by an independent radiology facility (IRF) for response.|BSR was measured at the end of Week 12 as determined by the IRF|Analysis was conducted on the randomized ITT population (61 cabozantinib, 58 mitoxantrone plus prednisone) for BSR at Week 12.|||percentage of responders||95% Confidence Interval|Number
2666567|NCT01522443|Primary|Pain Response at Week 6 Confirmed at Week 12, Week 12 Reported|The pre-specified primary analysis of Pain Response at Week 6 confirmed at Week 12 was defined as ≥ 30% from baseline in the average daily worst pain intensity score during a 7-day reporting period, with neither a concomitant increase in average daily use of any opioid narcotic type, nor addition of any new opioid narcotic type, relative to baseline. Pain Progression at a given time point is defined as ≥ 30% increase compared with baseline in the average daily worst pain intensity score during a 7-day reporting period or either an increase in the average daily use of any type of opioid narcotic or addition of a new opioid narcotic type compared with baseline.|Pain response was measured at Week 6 and Week 12 by self-reports of subjects|The primary analysis of pain response was based on the Intent to Treat (ITT) population of 119 participants (61 cabozantinib, 58 mitoxantrone plus prednisone).|||percentage of responders||95% Confidence Interval|Number
2666568|NCT01522404|Secondary|Change in FluoroDeoxyGlucose (FDG) Uptake in Participants With Mild Cognitive Impairment (MCI) Treated With Atomoxetine / Inactive Compound Compared to Participants Treated With Inactive Compound / Atomoxetine|Cerebral metabolic rate for glucose as measured by Fluoro Deoxy Glucose (FDG) uptake will be obtained by Positron Emission Tomography (PET) scan. The rates from the Baseline are compared to week 29 and week 58 among the subjects treated with Atomoxetine / Inactive Compound Compared to Participants Treated With Inactive Compound / Atomoxetine. . Cerebral glucose metabolism is reduced in early stages of AD. The ratio of hippocampal FDG-PET uptake to the whole brain average are presented below.|Baseline, Week 29 and Week 58|This analyses includes participants that completed 58 weeks of follow up.|||ratio||Standard Deviation|Mean
2666569|NCT01522404|Secondary|Rate of Cerebral Blood Flow in Subjects With Mild Cognitive Impairment MCI Treated With Atomoxetine / Inactive Compound Compared to Participants Treated With Inactive Compound / Atomoxetine|Change in rate of cerebral blood flow is assessed by arterial spin labeling Magnetic Resonance Imaging (ASL-MRI) in subjects with Mild Cognitive Impairment MCI treated with Atomoxetine / Inactive Compound compared to participants treated with Inactive compound / Atomoxetine. The rates from the Baseline are compared to week 29 and week 58 among the participants treated with Atomoxetine / Inactive Compound compared to participants treated with Inactive compound / Atomoxetine. All MRIs will be reviewed by the investigators and the investigator.|Baseline, Week 29, Week 58|This analysis includes participants who completed the entire study.|||mL/100 g/min||Standard Deviation|Mean
2666570|NCT01522404|Primary|Number of Participants That Drop Out of the Study Among the Participants Treated With Atomoxetine When Compared to the Participants Treated With Inactive Compound (Placebo)|Tolerability is measured by comparing the drop out rate among the participants treated with Atomoxetine to the participants treated with inactive compound (Placebo). Study predicts that treatment-associated (Atomoxetine Group) drop out rate will be < 15% .|Up to Week 58|"In Atomoxetine/Placebo group 20 participants got Atomoxetine during period 1 and 18 got Placebo during period 2.~In Placebo/ Atomoxetine group 19 participants got Placebo during period 1 and 19 participants got Atomoxetine during period 2.~Total for Atomoxetine (20 in period 1 + 19 in period 2) Total for Placebo (19 in period 1+ 18 in period 2)"|||Participants|||Count of Participants
2666571|NCT01522404|Primary|Number of All Adverse Events Among the Participants With Mild Cognitive Impairment (MCI) Treated With Atomoxetine Compared to the Participants Treated With Placebo/Inactive Compound|Safety was assessed by number of all adverse events among the participants treated with Atomoxetine compared to the participants treated with Placebo throughout the study. The Adverse Event assessment was done at each study visit through their participation in the study.|Up to Week 58|"In Atomoxetine/Placebo group 20 participants got Atomoxetine during period 1 and 18 got Placebo during period 2.~In Placebo/ Atomoxetine group 19 participants got Placebo during period 1 and 19 participants got Atomoxetine during period 2.~Total for Atomoxetine (20 in period 1 + 19 in period 2) Total for Placebo (19 in period 1+ 18 in period 2)"|||Adverse events|||Number
2666572|NCT01522404|Primary|Change in Mean Level of Thymus-Expressed Chemokine (TECK) in Cerebrospinal Fluid (CSF) in Participants With Mild Cognitive Impairment (MCI) Treated With Atomoxetine / Inactive Compound Compared to Participants Treated With Inactive Compound / Atomoxetine|This study will examine the effect of Atomoxetine and Inactive Compound on biomarkers of inflammation by measuring and comparing the mean levels of Thymus-Expressed Chemokine (TECK). These levels are measured using the assay of CSF at Baseline, Week 29 and Week 58. The study hypothesizes that the period that participants are treated with atomoxetine will have reduction in levels of these markers among both groups.|Baseline, Week 29 and Week 58|Only 49.1 % of the samples were above the limit of detection for TECK in CSF among the groups that are included in the analysis below. The levels for only 18 participants in Atomoxetine group and 18 participants in Inactive compound were analyzed|||pg/mL||Standard Deviation|Mean
2666589|NCT01522391|Secondary|Change in Area of Microbial Counting Site Full Analysis Set|Change from baseline (Day 1 morning) in area of microbial counting site measured in cm2.|Baseline, Day 7, Day 14 and Day 21|The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.|||cm2||Standard Deviation|Mean
2666590|NCT01522391|Secondary|Change in Total Treated Eczema Area Per Protocol Analysis Set|Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.|Baseline, Day 7, Day 14 and Day 21|The per protocol analysis set is defined as the patients who completed the study according to the protocol.|||cm2||Standard Deviation|Mean
2666573|NCT01522404|Primary|Change in Interleukin 1 (IL 1-alpha) in Cerebrospinal Fluid (CSF) in Subjects With Mild Cognitive Impairment (MCI) Treated With Atomoxetine/Inactive Compound Compared to Subjects Treated With Inactive Compound / Atomoxetine|This study will examine the effects of Atomoxetine and Inactive compound on biomarkers of inflammation by measuring and comparing the levels of Interleukin 1 (IL 1-alpha) using the assay of CSF at Baseline, Week 29 and Week 58 among the two groups. The study hypothesizes that the period that participants are treated with atomoxetine will have reductions in levels of these pro-inflammatory biomarkers among the two groups.|Baseline, Week 29 and Week 58|Only 15.1 % of the samples were above the limit of detection for Interleukin 1 (IL 1-alpha) alpha in CSF, precluding the planned analysis and comparing the mean and standard deviation of Interleukin 1 (IL 1-alpha) alpha levels in treatment versus placebo groups. Hence the analysis was not done and the outcome was not measured.||||||
2666574|NCT01522391|Secondary|Patient's Global Assessment of Eczema Change Per Protocol Analysis Set|Patient's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)|Day 7, Day 14 and Day 21|The per protocol analysis set is defined as the patients who completed the study according to the protocol.|||Participants|||Count of Participants
2666575|NCT01522391|Secondary|Patient's Global Assessment of Eczema Change Full Analysis Set|Patient's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)|Day 7, Day 14 and Day 21|The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.|||Participants|||Count of Participants
2666576|NCT01522391|Secondary|Change From Baseline in Visual Analog Scale of Itching (VASI) Per Protocol Analysis Set|The Visual Analog Scale of Itching (VASI), is the patient's assessment of itching on a 0-100 mm scale. 0 mm corresponds to no itching and 100 mm corresponds to maximum itching. Change from baseline is the change from day 1 morning.|Baseline, Day 7, Day 14 and Day 21|The per protocol analysis set is defined as the patients who completed the study according to the protocol.|||mm||Standard Deviation|Mean
2666577|NCT01522391|Secondary|Change From Baseline in Visual Analog Scale of Itching (VASI) Full Analysis Set|The Visual Analog Scale of Itching (VASI), is the patient's assessment of itching on a 0-100 mm scale. 0 mm corresponds to no itching and 100 mm corresponds to maximum itching. Change from baseline is the change from day 1 morning.|Baseline, Day 7, Day 14 and Day 21|The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.|||mm||Standard Deviation|Mean
2666578|NCT01522391|Secondary|Investigator's Global Assessment of Eczema Change Per Protocol Analysis Set|Investigator's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)|Day 7, Day 14 and Day 21|The per protocol analysis set is defined as the patients who completed the study according to the protocol.|||Participants|||Count of Participants
2666579|NCT01522391|Secondary|Investigator's Global Assessment of Eczema Change Full Analysis Set|Investigator's global assessment of eczema status since previous dose application on a categorical scale (worse, unchanged, improved)|Day 7, Day 14 and Day 21|The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.|||Participants|||Count of Participants
2666580|NCT01522391|Secondary|Lichenification Eczema Area and Severity Index (EASI) Per Protocol Analysis Set|Evaluation of lichenification on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe|Day 7, Day 14 and Day 21|The per protocol analysis set is defined as the patients who completed the study according to the protocol.|||Participants|||Count of Participants
2666581|NCT01522391|Secondary|Lichenification Eczema Area and Severity Index (EASI) Full Analysis Set|Evaluation of lichenification on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe|Day 7, Day 14 and Day 21|The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.|||Participants|||Count of Participants
2666582|NCT01522391|Secondary|Infiltration Eczema Area and Severity Index (EASI) Per Protocol Analysis Set|Evaluation of infiltration on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe|Day 7, Day 14 and Day 21|The per protocol analysis set is defined as the patients who completed the study according to the protocol.|||Participants|||Count of Participants
2666583|NCT01522391|Secondary|Infiltration Eczema Area and Severity Index (EASI) Full Analysis Set|Evaluation of infiltration on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe|Day 7, Day 14 and Day 21|The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.|||Participants|||Count of Participants
2666584|NCT01522391|Secondary|Excoriations Eczema Area and Severity Index (EASI) Per Protocol Analysis Set|Evaluation of excoriations on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe|Day 7, Day 14 and Day 21|The per protocol analysis set is defined as the patients who completed the study according to the protocol.|||Participants|||Count of Participants
2666585|NCT01522391|Secondary|Excoriations Eczema Area and Severity Index (EASI) Full Analysis Set|Evaluation of excoriations on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe|Day 7, Day 14 and Day 21|The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.|||Participants|||Count of Participants
2666586|NCT01522391|Secondary|Erythema Eczema Area and Severity Index (EASI) Per Protocol Analysis Set|Evaluation of erythema on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe|Day 7, Day 14 and Day 21|The per protocol analysis set is defined as the patients who completed the study according to the protocol.|||Participants|||Count of Participants
2666587|NCT01522391|Secondary|Erythema Eczema Area and Severity Index (EASI) Full Analysis Set|Evaluation of erythema on a scale 0-3 where 0=No symptoms, 1=Slight, 2=Moderate, 3=Severe|Day 7, Day 14 and Day 21|The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.|||Participants|||Count of Participants
2666588|NCT01522391|Secondary|Change in Area of Microbial Counting Site Per Protocol Analysis Set|Change from baseline (Day 1 morning) in area of microbial counting site measured in cm2.|Baseline, Day 7, Day 14 and Day 21|The per protocol analysis set is defined as the patients who completed the study according to the protocol.|||cm2||Standard Deviation|Mean
2666591|NCT01522391|Secondary|Change in Total Treated Eczema Area Full Analysis Set|Change from baseline (Day 1 morning) in total treated eczema area measured in cm2.|Baseline, Day 7, Day 14 and Day 21|The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.|||cm2||Standard Deviation|Mean
2666592|NCT01522391|Secondary|Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set|The gram-positive bacteria CFU count is the number of CFU/cm2 for gram-positive bacteria count in eczematous lesions.|Baseline, Day 7, Day 14 and Day 21|The per protocol analysis set is defined as the patients who completed the study according to the protocol.|||Percent change||Full Range|Median
2666593|NCT01522391|Secondary|Percent Change From Baseline in Gram-positive Bacteria CFU Count at Day 7, 14 and 21 Full Analysis Set|The gram-positive CFU count is the number of CFU/cm2 for gram-positive bacteria count in eczematous lesions.|Baseline, Day 7, Day 14 and Day 21|The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.|||Percent change||Full Range|Median
2666594|NCT01522391|Secondary|Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set|The KNS CFU count is the number of CFU/cm2 for coagulase-negative staphylococcus count in eczematous lesions.|Baseline, Day 7, Day 14 and Day 21|The per protocol analysis set is defined as the patients who completed the study according to the protocol.|||Percent change||Full Range|Median
2666595|NCT01522391|Secondary|Percent Change From Baseline in KNS CFU Count at Day 7, 14 and 21 Full Analysis Set|The KNS CFU count is the number of CFU/cm2 for coagulase-negative staphylococcus count in eczematous lesions.|Baseline, Day 7, Day 14 and Day 21|The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.|||Percent change||Full Range|Median
2666596|NCT01522391|Secondary|Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Per Protocol Analysis Set|The S.Aureus CFU count is the number of CFU/cm2 for S.Aureus count in eczematous lesions.|Baseline, Day 7, Day 14 and Day 21|The per protocol analysis set is defined as the patients who completed the study according to the protocol.|||Percent change||Full Range|Median
2666597|NCT01522391|Secondary|Percent Change From Baseline in S.Aureus CFU Count at Day 7, 14 and 21 Full Analysis Set|The S.Aureus CFU count is the number of CFU/cm2 for S.Aureus count in eczematous lesions.|Baseline, Day 7, Day 14 and Day 21|The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.|||Percent change||Full Range|Median
2666598|NCT01522391|Secondary|Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Per Protocol Analysis Set|The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.|Baseline, Day 7 and 21|The per protocol analysis set is defined as the patients who completed the study according to the protocol.|||Percent change||Full Range|Median
2666599|NCT01522391|Secondary|Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 7 and 21 Full Analysis Set|The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.|Baseline, Day 7 and 21|The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.|||Percent change||Full Range|Median
2666600|NCT01522391|Primary|Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Per Protocol Analysis Set|The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.|Baseline and Day 14|Per protocol analysis set is defined as the patients who completed the study according to the protocol.|||Percent change||Full Range|Median
2666601|NCT01522391|Primary|Percent Change From Baseline in Total Microbial Colony Forming Units (CFU) Count at Day 14 Full Analysis Set|The total microbial colony forming units count is the number of CFU/cm2 for total microbial count in eczematous lesions.|Baseline and Day 14|The full analysis set is defined as the patients who received at least one dose of the investigational product and produced study data beyond baseline.|||Percent change||Full Range|Median
2666602|NCT01522339|Secondary|MRI Image Quality|The following measures will be individually evaluated and compared to similar images previously acquired on an adult scanner: Overall Study Quality, Motion, Spatial Resolution, Signal to Noise, and Contrast.|Post MRI Scan for Each Infant|Number of NICU MRI Images with Equal or Better Quality than Adult Scanner Images|||Images|||Number
2666603|NCT01522339|Primary|Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam|Heart rate and oxygen saturation will be measured every 15+/- 5 minutes. The infants' temperatures will be taken immediately before the MRI and again immediately after the MRI. A physical exam will be performed both immediately before and immediately after the MRI to assess for any physical changes.|Day 1||||Adverse Events|||Number
2666604|NCT01522248|Primary|Levels of Cytokine Interferon Induced Gamma Protein (IP-10) Responses to Inactivated Influenza Vaccine|This was an exploratory trial to look at the kinetics of early (1st 48 hours) cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.|0 hours, 16 hours, 24 hours, 14 days|Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.|||pg/mL||Standard Deviation|Median
2666605|NCT01522248|Primary|Levels of Cytokine Interleukin 8 (IL-8) Cytokine Response to Inactivated Influenza Vaccine|This was an exploratory trial to look at the kinetics of early cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.|0 hours, 16 hours, 24 hours, 14 days|Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.|||pg/mL||Standard Deviation|Median
2666606|NCT01522248|Primary|Levels of Cytokine Interferon Gamma (IFN-gamma) Responses to Inactivated Influenza Vaccine|This was an exploratory trial to look at the kinetics of early cytokine response to influenza vaccine. Serum collected was assessed for cytokines, and PBMCs may be assessed for innate and adaptive immune responses, as well as for genetic markers associated with immune responses to vaccination. Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days.|0 hours, 16 hours, 24 hours, 14 days|Data for Cohort 1 reported as 0 hours and 24 hours. Data for Cohort 2 reported as 0 hours and 16 hours. Data was combined for the Cohorts and reported as 0 hours (baseline) and 14 days|||pg/mL||Standard Deviation|Median
2666607|NCT01522235|Secondary|Orthostatic Hypotension Symptom Assessment Questionnaire|"To determine the change in orthostatic Hypotension symptom (measured by the orthostatic hypotension symptom assessment questionnaire) measured at baseline and 6 weeks in individuals receiving IVIG. This is a 60 point orthostatic hypotenstion symptom assessment questionnaire. The minimum score possible is 0 and maximum is 60.~Higher values represent worse outcome. We are reporting the total score."|Baseline, 6 weeks||||units||Standard Deviation|Mean
2666608|NCT01522235|Secondary|EuroQol [EQ-5D] Questionnaire.|"To determine the change in quality of life (measured by the EuroQol [EQ-5D]) measured at baseline and 6 weeks in individuals receiving IVIg. We have reported the subscale (EQ-VAS). The minimum score is 0 and maximum score is 100. (0) corresponds to  the worst health you can imagine, and the highest rate (100) corresponds to the best health you can imagine."|Baseline, 6 weeks||||units||Standard Deviation|Mean
2666609|NCT01522235|Secondary|Composite Autonomic Severity Score (CASS) Questionnaire.|"To determine the change in autonomic symptoms (measured by the composite autonomic severity score [CASS]) measured at baseline and 6 weeks in individuals receiving IVIg.~Is a 10-point composite autonomic scoring scale of autonomic function. This scale allots 4 points for adrenergic and 3 points each for sudomotor and cardiovagal failure. Subjects with a score of 3 or less on have a mild autonomic failure, 4-6 have moderate autonomic failure and those with scores of 7 to 10 have severe failure. The minimum score possible is 3 and maximum is 10."|Baseline, 6 weeks||||units||Standard Deviation|Mean
2666610|NCT01522235|Secondary|Composite Autonomic Symptom Score [COMPASS] Questionnaire|To determine the change in autonomic symptoms (measured by the composite autonomic symptom score [COMPASS] questionnaire) measured at baseline and 6 weeks. Minimum and maximum score possible: 0-100. We have reported the Total score. Higher values represent worse outcome.|Baseline, 6 weeks||||units||Standard Deviation|Mean
2666611|NCT01522235|Secondary|Change in Systolic Blood Pressure During 60° Tilt (ΔSBP)|To compare the change in systolic blood pressure during 60 degree head up tilt table test after 6 and 12 weeks of IVIG (the within-patient difference in ΔSBP at 12 and 6 weeks among treated patients).|6 weeks and 12 weeks||||mmHg||Standard Deviation|Mean
2666612|NCT01522235|Primary|Change in Systolic Blood Pressure During 60° Tilt (ΔSBP)|The primary outcome, the change in systolic blood pressure during 60 degree tilt (ΔSBP), will be assessed in all study participants at baseline and at 6 weeks.|Baseline and 6 weeks||||mmHg||Standard Deviation|Mean
2666613|NCT01522131|Secondary|Clinical Evidence of Regeneration of Class 2 Furcation Defects Based on Changes in Vertical Pocket Depth Measurement(in mm)|Patients with periodontitis lose bone and clinical attachment over a period of time in vertical direction also. In both control and test a UNC probe marked in mm was used to quantify this loss or gain of clinical attachment in a vertical direction from the cemento-enamel junction to the most apical extent of the bone at the furcation entrance at baseline and after 6months after the procedure. These measurements were done intrasurgery and before opening of the flaps,again both at initial visit and 6 months after the procedure was done.This measurement will be measured in mm in postive numbers and then will be compared to measurements ( in mm) at intial and baseline. Increase and decrease of vertical probing depth will be noted by a positive number.|At Baseline and 6 months||||mm||Standard Deviation|Mean
2666614|NCT01522131|Primary|Change in Clinical Attachment( Gain or Loss) Measured by Horizontal Clinical Attachment Loss(in mm) From Baseline to 6 Months.|Patients with periodontitis lose bone and clinical attachment over a period of time. In both control and test a Nabers probe( curved probe) marked in mm was used to quantify this loss or gain of clinical attachment in a horizontal direction from the cemento-enamel junction to the the most apical extent of the bone at the furcation entrance at baseline and after 6months after the procedure. These measurements were done intrasurgery and before opening of the flaps,again both at initial visit and 6 months after the procedure was done. This measurement will be measured in mm in postive numbers and then will be compared to measurements ( in mm) at intial and baseline. If there is a loss in attachment it will be denoted by negative number. If theres a gain in attachment it will be denoted by a positive number after the comparison.|At Baseline and 6 months||||mm||Standard Deviation|Mean
2666615|NCT01521949|Secondary|Number of Participants With Increase in PSA Doubling Time in Comparison to Baseline|Doubling time of PSA is the time that it takes for PSA to increase by 100%. Doubling time was calculated prior to starting study treatment and after starting study treatment.|Two years|Intention to treat population|||Participants|||Count of Participants
2666616|NCT01521949|Primary|PSA Response, as Defined by ≥ 50% Decrease in PSA From Baseline|PSA will be obtained at baseline, every 6 weeks for the first 6 months, then every 3 months thereafter.|Two years|Intention to treat population|||Participants|||Count of Participants
2666617|NCT01521923|Secondary|Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 104 in RA0055 Period 2|"LDA is defined as achieving a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2.~DAS28 values range from 2.0 to 10.0 with a higher value indicating a higher disease activity."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
2666658|NCT01521897|Other Pre-specified|Number of Participants by Month of Age at Each Vaccination Time|Number of participants was counted by month of age at each vaccination time (first to fourth).|28 days|The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||Participants|||Number
2666618|NCT01521923|Secondary|Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|The Arthritis interference in the last month with household productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||units on a scale||Standard Deviation|Mean
2666619|NCT01521923|Secondary|Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of days missed of family/social/leisure activities in the last month.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||days||Standard Deviation|Mean
2666620|NCT01521923|Secondary|Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of days with hired outside help days in the last month.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||days||Standard Deviation|Mean
2666621|NCT01521923|Secondary|Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of days with reduced household work productivity in the last month.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||days||Standard Deviation|Mean
2666622|NCT01521923|Secondary|Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of days with no household work in the last month.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2."|||days||Standard Deviation|Mean
2666623|NCT01521923|Secondary|Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|"The Arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) for employed subjects.~Only the employed subjects were analyzed."|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO + MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||units on a scale||Standard Deviation|Mean
2666624|NCT01521923|Secondary|Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|"Number of work days with reduced productivity in the last month for employed subjects.~Only the employed subjects were analyzed."|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||days||Standard Deviation|Mean
2666625|NCT01521923|Secondary|Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2|Number of work days missed in the last month for employed subjects.|Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO + MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||days||Standard Deviation|Mean
2666626|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 104 in RA0055 Period 2|BRAF-MDQ total score ranges from 0 to 70 (with higher scores indicating worse fatigue), whereas the score for each dimension is different due to the varied number of questions (0 -22 for physical, 0- 21 for living, 0- 15 for cognition, and 0- 12 for emotion). A negative value in BRAF-MDQ change from Baseline indicates an improvement from Baseline.|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||units on a scale||Standard Deviation|Mean
2666627|NCT01521923|Secondary|Time to Flare From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"Time to flare, defined as an increase of DAS28[ESR] >= 0.6 above Week 52 DAS28[ESR] level, having a DAS28[ESR] >= 3.2 and judged by the Investigator as due to RA and all three criteria confirmed at an additional visit two weeks thereafter, from Week 52 onwards.~Data not available as > 75% of the participants failed to meet flare criteria."|Week 104 in RA0055 Period 2|"FAS2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses.~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||days||Geometric Coefficient of Variation|Geometric Mean
2666709|NCT01521546|Primary|12-month Change in Myocardial Strain|a sensitive measurement of heart function using cardiac MRI, change was 12 months minus baseline.|baseline and 12 months||||percent change in heart dimension||Inter-Quartile Range|Median
2666628|NCT01521923|Secondary|Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
2666629|NCT01521923|Secondary|Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 104 in RA0055 Period 2|"Normative physical function is defined as HAQ-DI score <= 0.5. The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.~The total score ranges from 0 to 3 with lower scores meaning lower disability."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
2666630|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.~The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline."|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||units on a scale||Standard Deviation|Mean
2666631|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.~The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||units on a scale||Standard Deviation|Mean
2666632|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined. CDAI ranges from 0-76 with lower scores indicating less disease activity and higher scores indicating higher disease activity.A negative value in CDAI change from Baseline indicates an improvement from Baseline.|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||units on a scale||Standard Deviation|Mean
2666633|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined. CDAI ranges from 0-76 with lower scores indicating less disease activity and higher scores indicating higher disease activity.~A negative value in CDAI change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||units on a scale||Standard Deviation|Mean
2666634|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 104 in RA0055 Period 2|"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity. DAS28[ESR] ranges from 0-10 with higher values representing higher disease activity.~A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline."|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||units on a scale||Standard Deviation|Mean
2666722|NCT01521260|Secondary|Complications and Adverse Events||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)|||||||
2666635|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 104 in RA0055 Period 2|"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity. DAS28[ESR] ranges from 0-10 with higher values representing higher disease activity.~A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||units on a scale||Standard Deviation|Mean
2666636|NCT01521923|Secondary|Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 104 in RA0055 Period 2|"Good response is defined as:~DAS28[ESR] <= 3.2 and decrease from Baseline by >1.2;~moderate response is defined as achievement of one of the following:~DAS28[ESR] <= 3.2 and decrease from Baseline > 0.6 and ≤ 1.2~DAS28[ESR] > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6~DAS28[ESR] > 5.1 and decrease from Baseline >1.2.~LOCF= Last Observation Carried Forward"|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
2666637|NCT01521923|Secondary|Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice at Week 104 in RA0055 Period 2|"The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as:~Tender Joint Count (TJC) <= 1, Swollen Joint Count (SJC) <= 1 and Patient's Global Assessment of Disease Activity (PtGADA) <= 10 mm."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
2666638|NCT01521923|Secondary|Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at Week 104 in RA0055 Period 2|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
2666639|NCT01521923|Secondary|Percentage of Subjects With Simplified Disease Activity Index (SDAI) <= 3.3 at Week 104 in RA0055 Period 2|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.~The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
2666640|NCT01521923|Secondary|Percentage of Subjects With Clinical Disease Activity Index (CDAI) <= 2.8 at Week 104 in RA0055 Period 2|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
2666641|NCT01521923|Secondary|Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 104 in RA0055 Period 2|"The ACR/EULAR 2011 remission criteria is defined as:~Tender Joint Count (TJC) <= 1, Swollen Joint Count (SJC) <= 1, C-Reactive Protein (CRP) <= 1 mg/dl and Patient's Global Assessment of Disease Activity (PtGADA) <= 10 mm."|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
2666656|NCT01521897|Other Pre-specified|Number of Participants by Pattern of Concomitant Vaccines|Number of participants was counted by each pattern of concomitant vaccination at each vaccination time (first to fourth). The concomitant vaccines (CVs) used were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).|28 days|The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||participants|||Number
2666642|NCT01521923|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 104 in RA0055 Period 2|The assessments are based on a 70 % or greater improvement from Baseline in previous study RA0055 Period 1 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
2666643|NCT01521923|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 104 in RA0055 Period 2|The assessments are based on a 50 % or greater improvement from Baseline in previous study RA0055 Period 1 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
2666644|NCT01521923|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 104 in RA0055 Period 2|The assessments are based on a 20 % or greater improvement from Baseline in previous study RA0055 Period 1 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
2666645|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2|Joint space narrowing (JSN) was assessed in 15 locations per hand and 6 locations per foot. Joint space narrowing for each location was scored from 0 to 4, with 0 indicating no narrowing. The minimum possible score for JSN in all 30 hand joints was 0, the maximum possible score for JSN in all 30 hand joints was 120. The minimum possible score for JSN in all 12 feet joints was 0, the maximum possible score for JSN in all 12 feet joints was 48. Thus, the minimum possible total JSN score for hands and feet was 0, the the maximum possible total JSN score for Hands and feet was 168. Higher values represent greater damage.|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."|||units on a scale||Full Range|Median
2666646|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2|Joint space narrowing (JSN) was assessed in 15 locations per hand and 6 locations per foot. Joint space narrowing for each location was scored from 0 to 4, with 0 indicating no narrowing. The minimum possible score for JSN in all 30 hand joints was 0, the maximum possible score for JSN in all 30 hand joints was 120. The minimum possible score for JSN in all 12 feet joints was 0, the maximum possible score for JSN in all 12 feet joints was 48. Thus, the minimum possible total JSN score for hands and feet was 0, the the maximum possible total JSN score for Hands and feet was 168. Higher values represent greater damage.|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."|||units on a scale||Full Range|Median
2666647|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2|"Erosions were assessed in 16 locations per hand and 6 joints per foot. Erosions for each hand location were scored from 0 to 5, with 0 indicating no erosion. Scores 1 to 5 may have included combinations of discrete erosion(s) and/or large erosions. Erosions for each foot joint were scored from 0 to 10, with 0 indicating no erosions.~The minimum possible total erosion score for all 32-hand joints was 0, the maximum possible erosion score for all 32-hand joints was 160. The minimum possible total erosion score for all 12-feet joints was 0, the maximum possible erosion score for all 12 feet joints was 120. Thus, the minimum possible total erosion score for hands and feet was 0, the maximum possible total erosion score for hands and feet was 280. Higher values represent greater damage."|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."|||units on a scale||Full Range|Median
2666657|NCT01521897|Other Pre-specified|Number of Participants by Vaccination Sites at Each Vaccination Time|Number of participants was counted by vaccination sites at each vaccination time (first to fourth).|28 days|The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||Participants|||Number
2666648|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2|"Erosions were assessed in 16 locations per hand and 6 joints per foot. Erosions for each hand location were scored from 0 to 5, with 0 indicating no erosion. Scores 1 to 5 may have included combinations of discrete erosion(s) and/or large erosions. Erosions for each foot joint were scored from 0 to 10, with 0 indicating no erosions.~The minimum possible total erosion score for all 32-hand joints was 0, the maximum possible erosion score for all 32-hand joints was 160. The minimum possible total erosion score for all 12-feet joints was 0, the maximum possible erosion score for all 12 feet joints was 120. Thus, the minimum possible total erosion score for hands and feet was 0, the maximum possible total erosion score for hands and feet was 280. Higher values represent greater damage."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."|||units on a scale||Full Range|Median
2666649|NCT01521923|Secondary|Percentage of Subjects With Radiographic Non-progression From Week 52 in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2|"Radiographic nonprogression is defined as change in modified Total Sharp Score (mTSS) <= 0.5.~Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage."|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."|||percentage of subjects|||Number
2666650|NCT01521923|Secondary|Percentage of Subjects With Radiographic Non-progression From Baseline in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2|"Radiographic nonprogression is defined as change in modified Total Sharp Score (mTSS) <= 0.5.~Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage."|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."|||percentage of subjects|||Number
2666651|NCT01521923|Secondary|Change From Week 52 in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2|Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."|||units on a scale||Full Range|Median
2666652|NCT01521923|Secondary|Change From Baseline in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2|Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.|From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2|"The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.~RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses."|||units on a scale||Full Range|Median
2666653|NCT01521923|Secondary|Percentage of Subjects With Disease Activity Score 28 [ESR] (DAS28 [ESR]) < 2.6 at Week 52 in Previous Study RA0055 Period 1 Who Maintain a DAS28 [ESR] < 2.6 From Week 52 in RA0055 Period 1 Through Week 104 in RA0055 Period 2 Without Flaring|DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity.|From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2|Full Analysis Set Period 2 (FAS2) with Non-Responder Imputation (NRI). FAS2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses.|||percentage of subjects|||Number
2666654|NCT01521923|Primary|Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring|This Outcome Measure includes all subjects that have a DAS28 [ESR] <= 3.2 from the start of RA0055 Period 2 (Week 52 of RA0055 Period 1) to Week 104 in RA0055 Period 2 without flaring.|Week 104 in RA0055 Period 2|"FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses~1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2"|||percentage of subjects|||Number
2666655|NCT01521897|Other Pre-specified|Number of Participants by Pattern of Concomitant Vaccination Sites|Number of participants was counted by each pattern of concomitant vaccination sites at each vaccination time (first to fourth). Vaccination sites of each concomitant vaccines and that of Prevenar™ (7-valent) (PVN7) were defined as follows: upper arm, UA; upper buttock, UB; femour, F; and oral route, O; R, right; L, left; same, same side of the vaccination site of PVN7; and other, other side of the vaccination site of PVN7. PVN7 was vaccinated at upper arm if not stated otherwise. The 1st to 4th represents the first to fourth vaccination of PVN7, respectively.|28 days|The analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||participants|||Number
2666659|NCT01521897|Secondary|Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination|Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||participants|||Number
2666660|NCT01521897|Secondary|Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination|Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) of over 39C° at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV).|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||Participants|||Number
2666661|NCT01521897|Secondary|Number of Participants With Injection Site Reactions|"Injection site reactions (erythema, induration, tenderness, and warmth) were defined by preferred terms of MedDRA/J version 16.0 as follows: erythema for injection site erythema; induration for injection site erythema and injection site swelling; tenderness for injection site pain; and warmth for injection site warmth."|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||Participants|||Number
2666662|NCT01521897|Secondary|Number of Participants With Serious Adverse Events|A serious adverse event was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||participants|||Number
2666663|NCT01521897|Primary|Number of Participants With Adverse Reactions|An adverse reaction was any untoward medical occurrence which was considered to be related to Prevenar™ (7-valent) in a participant who received Prevenar™ (7-valent). Relatedness to Prevenar™ (7-valent) was assessed by the sponsor (Pfizer Japan Inc.).|28 days|The safety analysis population comprised of participants who had received Prevenar™ (7-valent) at least once and provided the safety data and who did not meet the exclusion criteria for the safety analysis.|||participants|||Number
2666664|NCT01521884|Other Pre-specified|Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP) and Visual Analog Scale (VAS) Fatigue Score|Spearman correlation coefficient between DAS28-CRP and VAS score (DAS28-CRP vs VAS score) was calculated. DAS28-CRP was calculated from the number of SJC and TJC count using 28 joint count and CRP (mg/L). Total score range: 0-10, higher score= more disease activity. DAS28 (CRP): <3.2= low DA, >3.2 to 5.1 = moderate to high DA and <2.6 = remission and VAS= Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.|||correlation coefficient|||Number
2666665|NCT01521884|Other Pre-specified|Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR) and Visual Analog Scale (VAS) Fatigue Score|Spearman correlation coefficient between DAS28-ESR and VAS fatigue (DAS28-ESR vs VAS score) was calculated. DAS28-ESR calculated from the number of SJC and TJC using the 28 joints count, ESR (mm/hour) and participant's assessment of disease activity VAS (scores ranging 0 [very well] to 100 mm [extremely bad]). Total score range: 0-10, higher score= more disease activity. DAS28-ESR <= 3.2 = low DA, DAS28 > 3.2 to 5.1 = moderate to high DA and VAS fatigue = Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.|||correlation coefficient|||Number
2666666|NCT01521884|Other Pre-specified|Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale- Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)|Pearson correlation coefficient between AIMS2 component score and DAS28-CRP score (AIMS2 component score vs DAS28-CRP) was calculated. AIMS2: 78-item questionnaire assessing 12 scales. Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation DAS28-CRP was calculated from the number of SJC and TJC count using 28 joint count and CRP (mg/L). Total score range: 0-10, higher score= more disease activity. DAS28 (CRP): <3.2= low DA, >3.2 to 5.1 = moderate to high DA and <2.6 = remission.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.|||correlation coefficient|||Number
2666723|NCT01521260|Secondary|Implant Failure|defined as implant mobility of previously clinically osseointegrated implants and removal of non-mobile implants because of progressive marginal bone loss or infection|baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)|||||||
2666724|NCT01521260|Secondary|Marginal Soft Tissue Recession||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)|||||||
2666667|NCT01521884|Other Pre-specified|Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR)|Pearson correlation coefficient between AIMS2 component score and DAS28-ESR score (AIMS2 component score vs DAS28-ESR) was calculated. AIMS2: 78-item questionnaire assessing 12 scales. Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation and DAS28-ESR calculated from the number of SJC and TJC using the 28 joints count, ESR (mm/hour) and participant's assessment of disease activity VAS (scores ranging 0 [very well] to 100 mm [extremely bad]). Total score range: 0-10, higher score= more disease activity. DAS28-ESR <= 3.2 = low DA, DAS28 > 3.2 to 5.1 = moderate to high DA.|Baseline, Month 6,1 2, 18, 24|ITT population, Here “n” = participants evaluable for this measure for specified component score and “N” (number of participants analyzed) = participants who were evaluable for this measure. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.|||correlation coefficient|||Number
2666668|NCT01521884|Other Pre-specified|Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score|Spearman correlation coefficient between AIMS2 component score and VAS fatigue score (AIMS2 component score versus [vs] VAS fatigue) was calculated. AIMS2 : 78-item questionnaire assessing 12 scales. Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation and VAS score: Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.|||correlation coefficient|||Number
2666669|NCT01521884|Secondary|Health Assessment Questionnaire (HAQ) Total Score|HAQ: 20-item participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities. Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as sum of item scores. HAQ total score was 0 to 60 (as used in Belgium), where greater score indicated greater difficulty.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.|||units on a scale||Standard Deviation|Mean
2666670|NCT01521884|Secondary|Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)|DAS28-CRP was calculated from the number of swollen joints ( SJC) and tender joints (TJC) count using 28 joint count and CRP (milligram per liter [mg/L]). Total score range: 0-10, higher score= more disease activity. DAS28 (CRP) : <3.2= low disease activity, >3.2 to 5.1 = moderate to high disease activity and less than (<)2.6 = remission.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.|||units on a scale||Standard Deviation|Mean
2666671|NCT01521884|Secondary|Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR)|DAS28-ESR was calculated from the number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hour]) and participant's assessment of disease activity visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]). Total score range: 0-10, higher score=more disease activity (DA). DAS28-ESR less than equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high DA|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.|||units on a scale||Standard Deviation|Mean
2666672|NCT01521884|Secondary|Visual Analog Scale (VAS) Fatigue Score|Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.|Baseline, Month 6, 12, 18, 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score.|||units on a scale||Standard Deviation|Mean
2666673|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Month 24|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.|||units on a scale||Standard Deviation|Mean
2666725|NCT01521260|Secondary|Presence of Calculus||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)|||||||
2666726|NCT01521260|Secondary|Presence of Plaque||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)|||||||
2666674|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Month 18|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.|||units on a scale||Standard Deviation|Mean
2666675|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Month 12|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “N” (number of participants analyzed) = participants who were evaluable for this measure. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.|||units on a scale||Standard Deviation|Mean
2666676|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Month 6|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.|||units on a scale||Standard Deviation|Mean
2666677|NCT01521884|Primary|Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline|AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.|Baseline|ITT population included participants for whom the primary endpoint or 1 of the secondary endpoints could be determined at baseline. Here “n” = participants who were evaluable for this measure for specified component score. The results for social interaction and role components of AIMS2 were not analyzed due to change in planned analysis.|||units on a scale||Standard Deviation|Mean
2666678|NCT01521871|Primary|Patients´Self Satisfaction.|"The patients` self-satisfaction was evaluated by means of a questionnaire rating the following 3 domains on a numerical (1-5) scale:~Total satisfaction regarding wound healing/wound care. 1 (satisfied) to 5 (dissatisfied)~Satisfaction regarding wound discomfort; pain, itching, paresthesia, pressure etc. 1 (almost no discomfort) to 5 (lot of discomfort)~Satisfaction regarding wound care; suppleness, practicability versus mobilization, showering etc. 1 (almost no practical challenges) to 5 (lot of practical challenges)~Patients' Self Satisfaction score was the sum of three domains, ranges from 3 (completely satisfied) to 15 (completely dissatisfied).~These data were collected at the day of discharge, with guidance from two interviewers."|These data were collected at the day of discharge from hospital (postoperative day 4-8).||||units on a scale||Standard Deviation|Mean
2666679|NCT01521871|Primary|TIme Consumption|The specific time required for skin closure (tissue adhesive versus suture) was recorded, counted from initial application of adhesive/intracutaneous suture until final dressing.|The specific time required for skin closure (tissue adhesive versus suture) was recorded, counted from initial application of adhesive/intracutaneous suture until final dressing.||||minutes||Standard Deviation|Mean
2666680|NCT01521871|Primary|Wound Healing by Numerical Scales for Gaps at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for gaps (0: no gap - 3: need for resuture/strips). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7||||units on a scale||Standard Deviation|Mean
2666727|NCT01521260|Secondary|Radiographic Marginal Bone Level on Standardized Intraoral Radiographs||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)|||||||
2666681|NCT01521871|Primary|Wound Healing by Numerical Scales for Gaps Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for gaps (0: no gap - 3: need for resuture/strips). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 4||||units on a scale||Standard Deviation|Mean
2666682|NCT01521871|Primary|Wound Healing by Numerical Scales for Gaps Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for gaps (0: no gap - 3: need for resuture/strips). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 2||||units on a scale||Standard Deviation|Mean
2666683|NCT01521871|Primary|Wound Healing by Numerical Scales for Blisters at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for blisters (0: none - 3: abundant). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7||||units on a scale||Standard Deviation|Mean
2666684|NCT01521871|Primary|Wound Healing by Numerical Scales for Blisters Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for blisters (0: none - 3: abundant). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At postop. day 4 (4 days after kidney donation)||||units on a scale||Standard Deviation|Mean
2666685|NCT01521871|Primary|Wound Healing by Numerical Scales for Blisters Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for blisters (0: none - 3: abundant). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At postop. day 2 (2 days after kidney donation)||||units on a scale||Standard Deviation|Mean
2666686|NCT01521871|Primary|Wound Healing by Numerical Scales for Oedema at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for oedema (0-1; 0: no elevation - 1: oedema causing > 2 mm elevation). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7||||units on a scale||Standard Deviation|Mean
2666687|NCT01521871|Primary|Wound Healing by Numerical Scales for Oedema Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for oedema (0-1; 0: no elevation - 1: oedema causing > 2 mm elevation). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 4||||units on a scale||Standard Deviation|Mean
2666688|NCT01521871|Primary|Wound Healing by Numerical Scales for Oedema Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for oedema (0-1; 0: no elevation - 1: oedema causing > 2 mm elevation). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 2||||units on a scale||Standard Deviation|Mean
2666689|NCT01521871|Primary|Wound Healing by Numerical Scales for Secretion at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for secretion ((0-3; 0: totally dry - 3: continuous secretion). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7||||units on a scale||Standard Deviation|Mean
2666690|NCT01521871|Primary|Wound Healing by Numerical Scales for Secretion Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for secretion ((0-3; 0: totally dry - 3: continuous secretion). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 4||||units on a scale||Standard Deviation|Mean
2666691|NCT01521871|Primary|Wound Healing by Numerical Scales for Secretion Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for secretion ((0-3; 0: totally dry - 3: continuous secretion). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|Postop. day 2||||units on a scale||Standard Deviation|Mean
2666692|NCT01521871|Primary|Wound Healing by Numerical Scales for Rubor at Discharge From Hospital.|The evaluation is performed by the use of a previously set numerical scale for rubor (0-3; 0: pale, 3: typically infectious). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At departure from Surgical Dep. to the patients home, usually at postop. day 4, 5, 6 or 7||||units on a scale||Standard Deviation|Mean
2666693|NCT01521871|Primary|Wound Healing by Numerical Scales for Rubor Postoperative Day 4.|The evaluation is performed by the use of a previously set numerical scale for rubor (0-3; 0: pale, 3: typically infectious). Both arms/groups are evaluated day 4 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At postop. day 4 (4 days after kidney donation)||||units on a scale||Standard Deviation|Mean
2666728|NCT01521260|Secondary|Microbiological Composition of the Peri-implant Sulcus||baseline (T0), 3 and 12 months after intervention (T3, T12)|||||||
2666729|NCT01521260|Secondary|Suppuration on Probing||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)|||||||
2666730|NCT01521260|Secondary|Probing Pocket Depth||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)|||||||
2666694|NCT01521871|Primary|Wound Healing by Numerical Scales for Rubor Postoperative Day 2.|The evaluation is performed by the use of a previously set numerical scale for rubor (0-3; 0: pale, 3: typically infectious). Both arms/groups are evaluated day 2 postoperatively to measure any difference between the two skin closure methods. A high score is used as indicator of traumaticity towards the skin and a higher potential for wound infection.|At postoperative day 2 (2 days after kidney donation)||||units on a scale||Standard Deviation|Mean
2666695|NCT01521845|Secondary|MACE(Major Adverse Cardiac Effect) Defined as Need for Target Revascularization, Myocardial Infarction and Death||30 days||||participants|||Number
2666696|NCT01521845|Primary|Inflammation Marker (CRP)|difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention|8 and 24 hrs after percutaneous coronary intervention||||mg/l||Inter-Quartile Range|Median
2666697|NCT01521845|Primary|Cardiac Necrosis Biomarkers (CKMB, Troponin I)|difference between study and control group in 8 and 24 hrs after percutaneous coronary intervention|8 and 24 hrs after percutaneous coronary intervention||||ng/ml||Inter-Quartile Range|Median
2666698|NCT01521780|Secondary|Expression Levels of Low Density Lipoprotein Receptor (LDL-R) in Resected HCC and Adjacent Liver From Whole Tissue Sections.|Resected tumors and adjacent tissues were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for LDL-R protein by automated image analysis.|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.||||||
2666699|NCT01521780|Secondary|Expression Levels of Beta-catenin Protein From CNB Equivalents of Liver Adjacent to HCC.|Tissues adjacent to resected tumors were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin protein by automated image analysis.|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.||||||
2666700|NCT01521780|Secondary|Expression Levels of Beta-catenin mRNA From CNB Equivalents of Liver Adjacent to HCC.|Tissues adjacent to resected tumors were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin mRNA by qRT-PCR.|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.||||||
2666701|NCT01521780|Secondary|Median Apparent Diffusion Coefficient (Median ADC) of Tumors From Repeated MRI Measurements of HCC.|Two volumetric MRI and diffusion weighted (DW) MRI scans were performed without contrast on each participant. The two scans were separated by 10 to 15 minutes, and each scan was read by a separate reader to derive a Median ADC for each tumor. The mean of the Median ADCs is presented based on tumours as observation units.|Visit 2, approximately 7 days after screening Visit 1.|Eleven participants underwent MRI and DW MRI scans and only eight of their tumors were deemed measurable by both readers for analysis. Participants in both the Imaging and Imaging/Pathology treatment groups were combined for this analysis, whereas participants in the Pathology only treatment group were not analyzed for this outcome measure.|||um^2/s|Participants|Standard Deviation|Mean
2666702|NCT01521780|Secondary|Tumor Volumes From Repeated MRI Measurements of HCC.|Two volumetric MRI and diffusion weighted (DW) MRI scans were performed without contrast on each participant. The two scans were separated by 10 to 15 minutes, and each scan was read by a separate reader to determine the volume of each tumor. The mean of log tumor volume is presented, based on tumors as observation units.|Visit 2, approximately 7 days after screening Visit 1.|Eleven participants underwent MRI and DW MRI scans and only ten of their tumors were deemed measurable by both readers for analysis. Participants in both the Imaging and Imaging/Pathology treatment groups were combined for this analysis, whereas participants in the Pathology only treatment group were not analyzed for this outcome measure.|||log cm^3|Participants|Standard Deviation|Mean
2666703|NCT01521780|Primary|Expression Levels of Beta-catenin Protein From Core Needle Biopsy (CNB) Equivalents of Resected HCC.|Resected tumors were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin protein by automated image analysis.|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.||||||
2666704|NCT01521780|Primary|Expression Levels of Beta-catenin mRNA From Core Needle Biopsy (CNB) Equivalents of Resected HCC.|Resected tumors were fixed with formalin in paraffin embedded (FFPE) blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin messenger RNA (mRNA) by quantitative reverse transcription polymerase chain reaction (qRT-PCR).|Visit 3, approximately 7 days after screening Visit 1.|Due to early termination of the study, the low number of samples were not assayed and efficacy analyses were not performed.||||||
2666705|NCT01521559|Secondary|Change From Baseline in the National Eye Institute Visual Function Questionnaire - 25 (NEI VFQ-25) Questionnaire Total Score at Week 24 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.|Baseline to week 24|FAS|||scores on a scale||Standard Deviation|Mean
2666706|NCT01521559|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF|CRT was evaluated at every visit from baseline through week 24 using spectral domain Optical Coherence Tomography (OCT).|Baseline to week 24|FAS|||microns||Standard Deviation|Mean
2666707|NCT01521559|Secondary|Change From Baseline to Week 24 in BCVA Score - LOCF|Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24 - Last observation carried forward (LOCF) method was used to impute missing data.|Baseline to Week 24|FAS|||letters correctly read||Standard Deviation|Mean
2666708|NCT01521559|Primary|Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF|Best corrected visual acuity (BCVA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at every visit from baseline through week 24. Last observation carried forward (LOCF) method was used to impute missing data.|Baseline to week 24|FAS|||participants|||Number
2666731|NCT01521260|Secondary|Bleeding on Probing||baseline (T0), 3, 6 and 12 months after intervention (T3, T6, T12)|||||||
2666710|NCT01521507|Secondary|Stage 2 Mean Total OSDI Score at 12 Months|Dry eye symptoms assessed using the OSDI questionnaire were sensitivity to light, grittiness, pain or soreness, blurred vision and poor vision. The questionnaire evaluated the frequency problems with the eyes limited performance in reading, driving at night, working with a computer or bank machine, and watching television. Also, the frequency that eyes felt uncomfortable was assessed in windy conditions, areas with low humidity, and air-conditioned areas. Frequency scale was 0 (none of the time), 1 (some of the time), 2 (half of the time), 3 (most of the time), and 4 (all of the time). The total OSDI score was calculated as the sum of frequency scores for all symptoms multiplied by 25 and divided by the number of questions answered with a range from 0 to 100. A lower total OSDI score represents less disability from dry eye symptoms. The total OSDI score at 12 Months was compared across subgroups, as defined below.|12 Months|Intent to Treat (All participants who received at least a partial LipiFlow treatment or Crossover LipiFlow treatment and had data available at 12 Months). The Two LipiFlow treatments subgroup was not analyzed because the sample size (n<5) was too small for meaningful analysis.|||units on a scale||95% Confidence Interval|Mean
2666711|NCT01521507|Secondary|Stage 1 Mean Change in Total OSDI Score From Baseline to 3 Months|Dry eye symptoms assessed using the OSDI questionnaire were sensitivity to light, grittiness, pain or soreness, blurred vision and poor vision. The questionnaire evaluated the frequency problems with the eyes limited performance in reading, driving at night, working with a computer or bank machine, and watching television. Also, the frequency that eyes felt uncomfortable was assessed in windy conditions, areas with low humidity, and air-conditioned areas. The frequency scale was 0 (none of the time), 1 (some of the time), 2 (half of the time), 3 (most of the time), and 4 (all of the time). The total OSDI score was calculated as the sum of frequency scores for all symptoms multiplied by 25 and divided by the number of questions answered with a range from 0 to 100. A lower total OSDI score represents less disability from dry eye symptoms. To be eligible for the study, the Baseline total OSDI score must have been 13 points or higher in each eye. Change=3 Months score-Baseline score.|Baseline, 3 Months|Intent to Treat Population (All participants who were randomized and received at least partial device treatment or used warm compress at least once and had data available at 3 Months).|||units on a scale||95% Confidence Interval|Mean
2666712|NCT01521507|Primary|Stage 2 Mean Total Meibomian Gland Score at 12 Months|To assess the meibomian glands, the secretion characteristics from 15 gland orifices along the lower eyelid were evaluated under a slit lamp biomicrosope using a handheld instrument, Meibomian Gland Evaluator, to apply gentle standardized pressure to the eyelid margin. Expressed secretion characteristics were graded on a scale of 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated/toothpaste consistency), and 0 (no secretion). Total meibomian gland score was calculated based on the sum of the secretion grades for all 15 glands over a range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. The total meibomian gland score at 12 Months was compared across subgroups, as defined below.|12 Months|Intent to Treat Population (All participants who received at least partial LipiFlow or Crossover LipiFlow treatment and had data available at 12 Months). Two LipiFlow treatments subgroup was not analyzed because sample size was too small (n<5) for meaningful analysis.|||units on a scale||95% Confidence Interval|Mean
2666713|NCT01521507|Primary|Stage 1 Mean Change in Total Meibomian Gland Score From Baseline to 3 Months|To assess the meibomian glands, the secretion characteristics from 15 gland orifices along the lower eyelid were evaluated under a slit lamp biomicrosope using a handheld instrument, Meibomian Gland Evaluator, to apply gentle standardized pressure to the eyelid margin. Expressed secretion characteristics were graded on a scale of 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated/toothpaste consistency), and 0 (no secretion). Total meibomian gland score was calculated based on the sum of the secretion grades for all 15 glands over a range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. To be eligible for the study, the Baseline total meibomian gland score must have been 12 or less in each eye. Change = 3 Month score - Baseline Score.|Baseline and 3 Months|Intent to Treat Population (All Participants who were randomized and received at least partial LipiFlow treatment or used warm compress therapy at least once and had data available at 3 Months).|||units on a scale||95% Confidence Interval|Mean
2666714|NCT01521494|Secondary|Change From Baseline in Serum Intact-PTH Concentrations.||6 weeks|Some patients were excluded from analysis because they failed to have primary endpoint or missed to measure intact-PTH at the end of treatment.|||pg/mL||Standard Deviation|Mean
2666715|NCT01521494|Secondary|Change From Baseline in Serum Calcium Concentrations.||6 weeks|Total of 5 patients were excluded from analysis because they failed to have primary endpoint.|||mg/dL||Standard Deviation|Mean
2666716|NCT01521494|Primary|Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.|Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.|6 weeks|Total of 5 patients were excluded from analysis because they failed to have primary endpoint.|||mg/dL||95% Confidence Interval|Least Squares Mean
2666717|NCT01521364|Secondary|Area Under the Time Concentration Curve (AUC0-12h) of Linezolid in Saliva.|The data will be used to clinically validate the analysis linezolid in saliva as surrogate marker for linezolid in plasma.|At week 3 (after co-administration of 250mg clarithromycin)|||||||
2666718|NCT01521364|Secondary|Pharmacokinetic Parameters, e.g. Tmax, T1/2, Cmax, Cmin, Cl, of Anti-TB Drugs That Are Co-administered as Part of the Continued Standard Care.||At week 1 (baseline), week 3 (250mg clarithromycin) and week 5 (500mg clarithromycin)|||||||
2666719|NCT01521364|Secondary|Number of Patients With Adverse Events (AEs)|To assess short-term safety and tolerability when combining linezolid (LIN) with clarithromycin (CLA) by monitoring AEs, i.e. gastro-intestinal effects, hyperlactatemia, haematological abnormalities and neuropathy.|Up to week 6|No serious adverse events|||participants|||Number
2666720|NCT01521364|Secondary|Linezolid (LIN) and Clarithromycin (CLA) Pharmacokinetic Parameters, e.g. Tmax, Cmax, Cmin, T1/2, Cl.||At week 1 (baseline), week 3 (250mg clarithromycin), and week 5 (500mg clarithromycin) and week 6 (baseline).|||||||
2666721|NCT01521364|Primary|Area Under the Time Concentration Curve (AUC0-12h) of Linezolid in Plasma After Addition of 0mg, 250mg, or 500mg Clarithromycin (CLA).|"The AUCs of linezolid will be measured at 3 time points after addition of 3 different clarithromycin dosages.~Samples were obtained before doseing and 1h, 2h, 3h, 4h, 8h, and 12h after administration of linezolid (and claritromycin depending on the period)."|At week 1 (baseline), week 3 (250mg clarithromycin), and week 5(500mg clarithromycin).||||mg*h/L||Inter-Quartile Range|Median
2666732|NCT01521260|Primary|Change in Total Bacterial Load on the Exposed Implant Surface|Total bacterial load as obtained by sweeping a microbrush across the implant surface after flap deflection. Samples are obtained immediately after flap deflection and granulation tissue removal AND after the decontamination procedure (mechanical debridement, rinsing of the implant surface using the placebo or chlorhexidine solution, saline rinsing) but before flap closure. The log-transformed mean change in bacterial load is calculated (difference between the two time points --> difference in sample BEFORE decontamination and AFTER decontamination procedure).|During the surgical procedure: 1. immediately after flap deflection and granulation tissue removal AND 2. after the decontamination procedure but before flap closure.||||log (colony forming units/ml)|Participants|Standard Deviation|Log Mean
2666733|NCT01521143|Secondary|Part B - Progression-free Survival|Progression-free survival was defined as the number of days from Baseline and the documented disease progression as defined by response evaluation criteria in solid tumors (RECIST) or death, whichever occurred earlier. Disease progression was defined as any measurable new lesion(s) that were accurately measured in at least 1 dimension. Any new lesion(s) with a minimum size of 20 mm were deemed as unequivocal (ie, clear or definite) progression. Any new lesion(s) with a minimum size of 15 mm but smaller than 20 mm were considered equivocal progression and had to be confirmed by a follow-up radiological procedure.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.||||||
2666734|NCT01521143|Secondary|Part B - Time to Next Treatment|Time to next treatment was defined as the number of days from Baseline to the date when the next treatment for epithelial ovarian cancer was started.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.||||||
2666735|NCT01521143|Secondary|Part B - Overall Survival|Overall survival was defined as the number of days from Baseline to the date of death from any cause.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.||||||
2666736|NCT01521143|Secondary|Part A - Progression-free Survival|Progression-free survival was defined as the number of days from Baseline and the documented disease progression as defined by response evaluation criteria in solid tumors (RECIST) or death, whichever occurred earlier. Disease progression was defined as any measurable new lesion(s) that were accurately measured in at least 1 dimension. Any new lesion(s) with a minimum size of 20 mm were deemed as unequivocal (ie, clear or definite) progression. Any new lesion(s) with a minimum size of 15 mm but smaller than 20 mm were considered equivocal progression and had to be confirmed by a follow-up radiological procedure.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.||||||
2666737|NCT01521143|Secondary|Part A - Time to Next Treatment|Time to next treatment was defined as the number of days from Baseline to the date when the next treatment for epithelial ovarian cancer was started.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.||||||
2666738|NCT01521143|Primary|Part A - Overall Survival|Overall survival was defined as the number of days from Baseline to the date of death from any cause.|Baseline to the end of the study (up to 3 years, 2 months)|Intent-to-treat population: All participants who were randomized to a treatment group. The data for this Outcome Measure were not analyzed since the study was terminated early.||||||
2666739|NCT01521026|Secondary|Hopkins Verbal Learning Test Percent Retained|"Verbal list learning task with three learning trials and a delay trial. Percent retained refers to the percentage of items recalled at the delay trial, compared to the third learning trial.~Score ranges from 0-100. Higher scores represent better performance."|3 months||||units on a scale||Standard Deviation|Mean
2666740|NCT01521026|Primary|UCSD Performance-based Skills Assessment Total Score (Measures Functional Capacity)|Performance-based measure of functional capacity in five domains: Communication, Finance, Recreation Planning, Transportation, and Household Chores Scale ranges from 0-100. Subscales are summed to yield the total score. Higher scores represent better performance.|3 months||||units on a scale||Standard Deviation|Mean
2666741|NCT01520987|Primary|Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)|"Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.~Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose"|Day 10||||hours||Full Range|Median
2666742|NCT01520987|Primary|Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)|"Tmax of BIA 9-1067 - time taken to reach maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.~Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose"|Day 1||||hours||Full Range|Median
2666743|NCT01520987|Primary|AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 10)|"AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.~Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose"|Day 10||||ng.h/mL||Standard Deviation|Mean
2666818|NCT01520532|Secondary|Acute Safety Events|Assess the number of procedure or device-related serious adverse events when applying best practices with PVAC.|30 days|All subjects who underwent an ablation and post-procedure MRI|||events|||Number
2666744|NCT01520987|Primary|AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 1)|AUC0-∞ - area under the concentration of BIA 9-1067-time curve (AUC) from time zero to infinity following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose|Day 1||||ng.h/mL||Standard Deviation|Mean
2666745|NCT01520987|Primary|AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 10)|"AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.~Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose"|Day 10||||ng.h/mL||Standard Deviation|Mean
2666746|NCT01520987|Primary|AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 1)|"AUC0-t - area under the concentration-time curve (AUC) from time zero to last time point with concentrations above the lower limit of quantitation of BIA 9-1067 following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.~Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose."|Day 1||||ng.h/mL||Standard Deviation|Mean
2666747|NCT01520987|Primary|Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)|"Cmax - maximum observed plasma concentration following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects.~Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose"|Day 10||||ng/mL||Standard Deviation|Mean
2666748|NCT01520987|Primary|Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)|Cmax - maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.|Day 1||||ng/mL||Standard Deviation|Mean
2666749|NCT01520922|Secondary|Number of Participants With an Adverse Event of Any Infusion Reactions (IR) or Serious Infusion Reactions (SIR)|An Infusion reaction is defined as events occurring after the beginning of an infusion of ofatumumab or within 24 hours following the end of an infusion of bendamustine.|From the first dose of study medication to 60 days after the last dose of study medication (up to 24 hours after last dose of study treatment)|Safety Population: All subjects who receive at least one dose of study medication.|||Participants|||Number
2666750|NCT01520922|Secondary|Number of Participants With Zeta-chain-associated Protein Kinase (ZAP) 70 Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment|ZAP-70 is a protein normally expressed near the surface membrane of T cells and natural killer cells. ZAP-70 in B cells is used as a prognostic marker in identifying different forms of CLL. Participants with ZAP-70 testing results intermediate (Int), positive (Pos) and negative (Neg) at Baseline and who had a clinical response after last dose of study treatment are provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.|From the start of study treatment until earliest date of disease progression or death (up to 3 months following last dose of study treatment)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
2666751|NCT01520922|Secondary|Number of Participants With the Indicated Immunoglobulin Heavy Chain Variable Region (IgVH) Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment|Participants with IgVH mutation results as mutated and unmutated status and clinical response after last dose of study treatment were provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.|From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
2666752|NCT01520922|Secondary|Number of Participants With the Indicated Beta 2 Microglobulin (B2M) at Baseline Who Also Had a Clinical Response After the Last Dose of Study Treatment|Participants with B2M concentration of <=4000 µg/L and >4000 µg/L at Baseline and who had clinical response after the last dose of study treatment were provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow Recovery (CRi), nodular partial remission (nPR), and partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.|From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
2666819|NCT01520532|Primary|New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI.|An acute embolic lesion is defined as a focal hyper-intense area detected on the diffusion-weighted (DW) sequence, corresponding to a hyper-intense signal intensity in the fluid-attenuated inversion recovery (FLAIR) sequence, and also confirmed by apparent diffusion coefficient (ADC) mapping to rule out a shine-through artifact.|Within 1-3 days post ablation|All subject who underwent an ablation and post-procedure MRI.|||participants|||Number
2666753|NCT01520922|Secondary|Number of Participants With the Indicated Cytogenetics Testing at Baseline Who Also Had a Clinical Response After Last Dose of Study Treatment|Cytogenetics refers to the study of numerical and structural chromosomal abnormalities. Cytogenetics (analyzed by fluorescent in situ hybridization [FISH]) of 17p deletion, 11q deletion, 17p or 11q deletions, 6q- or +12q or 13q- deletions, and no aberration at Baseline were summarized by clinical responses after the last dose of study treatment. Clinical responses included complete remission (CR), nodular partial remission (nPR), complete response with incomplete bone marrow Recovery (CRi), partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders.|From the start of study treatment until earliest date of disease progression or death (up to up to 3 months following last dose of study treatment)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
2666754|NCT01520922|Secondary|Number of Participants With the Indicated Reduction in Organomegaly (Spleen and Liver)|Organomegaly is the abnormal enlargement of organs. Physical examination of the liver (L) and spleen (S) were done at Screening (SCR), C3D1, C6D1, 12-Month F/U, 24-Month F/U and 36-Month F/U. The result of the physical examination of the liver (L) and spleen (S) was presented as normal (NOR), enlarged (EL) and not assessed (NOA).|Screening (Scr), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 -Month Follow-Up (F/U)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
2666755|NCT01520922|Secondary|Maximum Decrease in Sum of the Product of the Diameter (SPD) From Baseline in Participants With Lymphadenopathy at Baseline|Lymph nodes were evaluated by physical examination which involved recording the diameter in two planes (sum of the product of the diameter [SPD]) of the largest palpable node in each of the following sites: cervical, axillary, supraclavicular, inguinal and femoral. Lymphadenopathy is defined as lymph nodes with the largest diameter greater than 1.5 centimeters. The maximum reduction in SPD from Baseline at C2D1, C3D1, C4D1, C5D1, C6D1, 3-Month F/U, 6-Month F/U and 9-Month F/U are provided.|Baseline, Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), Cycle 4 Day 1 (C4D1), Cycle 5 Day 1 (C5D1), Cycle 6 Day 1 (C6D1), 3-Month Follow-Up (F/U), 6-Month F/U and 9-Month F/U|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||cm^2 (centimeters squared)||Standard Deviation|Mean
2666756|NCT01520922|Secondary|Number of Participants With Confirmed Positive Response for Human Anti-human Antibodies (HAHA) at the Indicated Time Points|The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. All samples were first assessed in a screening (SCR) assay, and the potential positive (Pos) samples were further tested in the confirmation (CNF) assays. Confirmed positives were reported as HAHA positive and titer was determined for each positive sample. The drug tolerance of the HAHA assay is 200 microgram/milliliter (µg/mL); thus, samples that tested negative in the assay and had ofatumumab concentrations no more than 200 µg/mL were considered as conclusive negative (C Neg) results.|Cycle 1 Day 1 (C1D1), Cycle 6 Day 1 (C6D1), 6-Month Follow-up (F/U), and any post-dose time point|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
2666757|NCT01520922|Secondary|Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)|The ECOG performance status scales and criteria are used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead.|Baseline (BL), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 month follow up (F/U)|Safety Population. All subjects who receive at least one dose of study medication.. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
2666758|NCT01520922|Secondary|Number of Participants With the Indicated Constitutional or B-symptoms|Participants with the indicated constitutional or B-symptoms (night sweats, weight loss, fever or extreme fatigue) were presented for different time points.|Screening (SCR), Cycle 3 Day 1 (C3D1), Cycle 6 Day 1 (C6D1), 12, 24 and 36 Month Follow-up (F/U)|Safety Population: All subjects who receive at least one dose of study medication. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
2666759|NCT01520922|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Event of Infection|Participants with the indicated Grade 3 or Grade 4 adverse event of infection are presented. AEs were graded according to the NCI CTCAE grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE|Safety Population: All subjects who receive at least one dose of study medication.|||Participants|||Number
2666760|NCT01520922|Secondary|Number of Participants With the Indicated Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, and Thrombocytopenia), as Assessed by the Investigator|Participants with a Grade 3 or Grade 4 myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).|From the first dose of study medication to 60 days after the last dose of study medication|Safety Population|||Participants|||Number
2668322|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Slope)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the slope of the regression equation comparing observed vs. predicted weight.|study day 1|Final population for data analysis.|||unitless||95% Confidence Interval|Number
2666761|NCT01520922|Secondary|Number of Participants With Autoimmune Hemolytic Anaemia (AIHA) Disease|"AIHA is a disease where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented."|From first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE|Safety Population All subjects who receive at least one dose of study medication.|||Participants|||Number
2666762|NCT01520922|Secondary|Number of Participants Who Received no Transfusion or at Least One Transfusion During the Study|Participants who received no transfusion and at least one transfusion during the study are presented. Participants who took any blood products are counted in this table.|From start of treatment until earliest date of disease progression or death (up to 3 years after the last dose of study treatment)|Safety Population: All subjects who receive at least one dose of study medication.|||Participants|||Number
2666763|NCT01520922|Secondary|Number of Participants Who Were Negative or Positive for Minimal Residual Disease (MRD) and Achieved a Bone Marrow Biopsy Confirmed Complete Response (CR) up to 36-Month Follow-up|MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed CR. MRD analysis was performed for the partcipants who were suspected of achieving a primary endpoint CR. Analysis of CD5+ CD19+ was performed on the bone marrow aspirate sample obtained no sooner than 2 months following the last dose of study treatment. MRD results were reported as negative or positive. The absence of MRD (negative MRD) is defined as less than one CLL cell per 10000 leukocytes.|3 month follow up to the 36 Month Follow-up (in 3 month interval)|ATS Population. Number of subjects who had CR with bone marrow confirmation are included. Only those participants with data available at the specified time points were analyzed.|||Participants|||Number
2666764|NCT01520922|Secondary|Change From Baseline in Cluster of Differentiation (CD) CD5-CD19+ Cell Counts up to 36 Months|CD5-CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5- CD19+ cell count value is the last pre-dose assessment values performed on cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, 3-Month Follow-up to 36-Month Follow-up (in 3 months interval)|Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Cell per microliter||Standard Deviation|Mean
2666765|NCT01520922|Secondary|Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ Cell Counts up to 36 Months|CD5+ CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5+ CD19+ cell count value is the last pre-dose assessment values performed on cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, 3-Month Follow-up to 36-Month Follow-up (in 3 months interval)|ATS Population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Cell per microliter||Standard Deviation|Mean
2666766|NCT01520922|Secondary|Change From Baseline in the Immunoglobulin (Ig) Antibodies to End of Study Treatment|Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and end of study treatment (up to 30 months)|Safety Population. Only those participants who were available at the indicated time points were analyzed.|||Gram per liter||Standard Deviation|Mean
2666767|NCT01520922|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From first dose of study medication to 60 days after the last dose of study medication (if the event is considered as an AE), or up to 3 years after the last dose of study treatment or until the time of the next anti-CLL therapy, if considered a SAE|Safety Population: all participants who received at least one dose of any study treatment (ofatumumab or bendamustine).|||Participants|||Number
2666768|NCT01520922|Secondary|Time to Next Therapy|Time to next therapy is defined as the time from the date of the first administration of study treatment until the start of the next anti-CLL therapy.|From the start of study treatment until the start of the next anti-CLL therapy (up to 3 years after the last dose of study treatment)|ATS Population. Only participants that took anti-CLL therapy were evaluated.|||Months||95% Confidence Interval|Median
2666769|NCT01520922|Secondary|Investigator-Assessed Kaplan-Meier Estimates of Time to Progression|Time to progression is defined as the time from the date of the first administration of study treatment to disease progression (PD). PD requires at least one of the following: new lesion or increase by >=50% from Baseline in lymphocytes (LC) with at least 5000 B-lymphocytes per microliter (5.0 x 10^9/L), lymphadenopathy (Ly), size of liver and spleen, platelets (PL) >= 50% decrease from Baseline, or to <100,000/uL secondary to CLL, hemoglobin (Hb) decrease of >2 g/dL from Baseline or to <10 g/dL secondary to CLL, CLL- transformation, cytopenia after treatment. Response was determined according to the IWCLL updated NCI-WG guidelines 2008.|From the start of study treatment to disease progression (up to 3 years after the last dose of study treatment)|All treated subjects (ATS). This analysis includes patients who had progression.|||Months||95% Confidence Interval|Median
2666770|NCT01520922|Secondary|Investigator-assessed Kaplan-meier Estimates of Overall Survival|OS is defined as the interval of time between the date of the first administration of study treatment and the date of death due to any cause. For participants who did not die, time of death was censored at the date of last contact.|From the start of study treatment to the date of death due to any cause (up to 3 years after the last dose of study treatment)|All treated subjects. N= Death|||Months||95% Confidence Interval|Median
2666771|NCT01520922|Secondary|Investigator-assessed of Kaplan-meier Estimates of Progression-free Survival (PFS)|PFS is defined as the interval of time between the date of the first administration of study treatment and the earlier of the date of disease progression (PD) and the date of death due to any cause. PD requires at least one of the following:new lesion or increase by >=50% from BL in LC, Ly, size of liver and spleen, PL >= 50% decrease from BL, or to <100,000/uL secondary to CLL, Hb decrease of >2 g/dL from BL or to <10 g/dL secondary to CLL, CLL- transformation. Response was determined according to the IWCLL updated NCI-WG guidelines 2008. Participants who have neither progressed or died at the time of analysis were censored at the date of the last adequate assessment. If there was more than 1 scheduled visit missed, PFS is censored at the last adequate assessment of response. An adequate assessment is defined as an assessment where the investigator determined a response of CR, CRi, nPR, PR, or stable disease (SD).|From the start of study treatment until earliest date of disease progression or death (up to 3 years after the last dose of study treatment)|All Treated Subjects’ (ATS) population. N= Progression or Death|||Months||95% Confidence Interval|Median
2666772|NCT01520922|Secondary|Investigator-assessed Kaplan-meier Estimates of Duration of Response|The duration of response is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of disease progression (PD) or death due to any cause. PD requires at least one of the following: new lesion or increase by >=50% from Baseline in lymphocytes (LC) with at least 5000B-lymphocytes per microliter (5.0 x 10^9/L), lymphadenopathy (Ly), size of liver and spleen, platelets (PL) >= 50% decrease from Baseline, or to <100,000/uL secondary to CLL, hemoglobin (Hb) decrease of >2 g/dL from Baseline or to <10 g/dL secondary to CLL, CLL- transformation, cytopenia after treatment. Response was determined according to the IWCLL updated NCI-WG guidelines 2008.|From time of initial response (CR, CRi, nPR, or PR) to disease progression or death, whichever came first (up to 3 years after the last doseof study treatment)|ATS Population. Only participants with an initial response (CR, CRi, nPR, or PR) with PD or death were assessed for duration of response.|||Months||95% Confidence Interval|Median
2666773|NCT01520922|Secondary|Investigator-assessed Kaplan-meier Estimates of Time to Response|Time to response is defined as time from date of the first administration of study treatment to the first response (CR, CRi, nPR, or PR). Response was determined according to the IWCLL updated NCI-WG guidelines 2008. CR: all of the following criteria at least 2 months after last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/ thrombocytopenia/ neutropenia unrelated to CLL but related to drug toxicity. nPR: persistent nodules BM. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11.0 g/dL or 50% improvement over BL, LC <4000/µL.|From the start of study treatment to the first response (CR, CRi, nPR, or PR) (up to 3 Month Follow-up (F/U) visit)|ATS Population. Only participants who had a response (CR, CRi, nPR, or PR) were evaluated.|||Months||95% Confidence Interval|Median
2666774|NCT01520922|Secondary|Number of Participants With Complete Response (CR) With and Without a CT Scan Assessment After the Last Dose of Study Treatment, as Assessed by the Investigator|Response was determined according to the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria at least 2 months after the last treatment: no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500/µL, platelets (PL) >100,000/µL, hemoglobin (Hb) >11.0 g/dL, lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule.|From the start of study treatment until 3 months after the last dose of study treatment|ATS Population|||Participants|||Number
2666775|NCT01520922|Secondary|Number of Participants With Overall Response (OR) With Computed Tomography (CT) Scan (CT Scan) Assessment, as Assessed by the Investigator|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]), after 3 cycles, after 6 cycles, and after the last dose of ofatumumab and bendamustine treatment. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL, LC <4000/µL. nPR: persistent nodules BM.|From the start of study treatment until 3 months after the last dose of study treatment|ATS Population. OR was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008.|||Participants|||Number
2666776|NCT01520922|Primary|Number of Participants With Overall Response (OR), as Assessed by the Investigator|OR is defined as the number of participants achieving an objective response (complete response [CR], CR with incomplete bone marrow recovery [CRi], partial response [PR], and nodular PR [nPR]), after 3 cycles, after 6 cycles, and after the last dose of ofatumumab and bendamustine treatment. CR (all the criteria at least 2 months after last treatment): no lymphadenopathy (Ly)/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils >1500 per microliter (µL), platelets (PL) >100,000/µL, hemoglobin (Hb) >11 grams/deciliter (g/dL), lymphocytes (LC) <4000/µL, bone marrow (BM) sample must be normocellular for age, <30% LC, no lymphoid nodule. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. PR: >=50% decrease in LC, Ly, size of liver and spleen and at least one of the following results: PL >100,000/µL or 50% improvement over Baseline (BL), Hb >11 g/dL or 50% improvement over BL, LC <4000/µL. nPR: persistent nodules BM.|From the start of study treatment until 3 months after the last dose of study treatment|As-treated subjects (ATS) Population: all participants who received at least one dose of both study drugs (ofatumumab and bendamustine). OR was measured using the International Workshop for CLL (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines 2008. The 95% exact binomial confidence interval is for CR+CRi+nPR+PR.|||Participants|||Number
2668633|NCT01503333|Other Pre-specified|Social Support for Physical Activity|To measure assistance for physical activity received form others, an 8-item Social Support Scale was used. Response choices ranged form (0) never to (3) often. Higher score means better outcome.|baseline to post-intervention||||score on a scale||Standard Deviation|Mean
2666777|NCT01520909|Secondary|Population PK Model Point Estimate for Eltrombopag for Absorption Rate-constant (Ka)|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. Ka is defined as the absorption rate constant. This parameter is dose independent, and the population estimate Ka is reported.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed|||1/h|||Number
2666778|NCT01520909|Secondary|PK Assessments for Eltrombopag for Apparent Central Volume (Vc/F) and Apparent Peripheral Volume (Vp/F)|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. Vc/F is defined as the volume of the central (e.g. plasma) compartment and Vp/F is defined as the volume of the peripheral compartment. These parameters are dose independent. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed|||Liters (L)||95% Confidence Interval|Geometric Mean
2666779|NCT01520909|Secondary|Pharmacokinetic (PK) Assessments for Eltrombopag for Apparent Oral Clearance (CL/F) and Apparent Intercompartmental Clearance (Q/F)|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. CL/F is defined as the apparent oral clearance from plasma and Q/F is defined as apparent intercompartmental clearance. These parameters are dose independent. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed|||Liters per hour (L/hr)||95% Confidence Interval|Geometric Mean
2666780|NCT01520909|Secondary|Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. Cmax is defined as the maximum observed concentration. The Cmax for a 50mg dose was estimated for each cohort. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed|||micrograms per milliliter (ug/mL)||95% Confidence Interval|Geometric Mean
2666781|NCT01520909|Secondary|Pharmacokinetic (PK) Assessments for Eltrombopag for AUC (0-t)|Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. AUC(0-t) is defined as the area under the concentration-time curve over the dosing interval. The AUC(0-t) for a 50mg dose was estimated for each cohort. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.|Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)|PK Population. Only those participants who provided pharmacokinetic samples were analyzed|||micrograms*hour per milliliter (ug.h/mL)||95% Confidence Interval|Geometric Mean
2666782|NCT01520909|Secondary|Number of Participants With Worsening Visual Acuity Due to Cataracts at Follow-Up Week 24|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with worsening visual acuity due to cataracts at Follow-up Week 24 are presented. Change due to cataracts is categorized as Yes or No."|Baseline and Follow-Up Week 24 (Week 61)|Safety Population. Only those participants who had worsening visual acuity at Week 61 were analyzed.|||Participants|||Number
2666783|NCT01520909|Secondary|Number of Participants With Worsening Visual Acuity Due to Cataracts at Week 24 of Part 2|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with worsening visual acuity due to cataracts at Week 24 of Part 2 are presented. Change due to cataracts is categorized as Yes or No."|Baseline and Week 24 of Part 2|Safety Population. Only those participants who had worsening visual acuity at Week 24 were analyzed.|||Participants|||Number
2666784|NCT01520909|Secondary|Number of Participants With Worsening Visual Acuity Due to Cataracts at Week 12 of Part 1|"The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with worsening visual acuity due to cataracts at Week 12 of Part 1 are presented. Change due to cataracts is categorized as Yes or No."|Baseline and Week 12 of Part 1|Safety Population. Only those participants who had a result of ‘worsening’ in assessment of change of visual acuity at this timepoint were analyzed.|||Participants|||Number
2666785|NCT01520909|Secondary|Number of Participants With a Change in Visual Acuity Since Baseline at Follow-Up Week 24|The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Change in visual acuity results are presented as No Change, NCS, Improvement, and Worsening since Baseline. The Baseline value was obtained at the Screening Visit.|Baseline and Follow-Up Week 24 (Study Week 61)|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.|||Participants|||Number
2666858|NCT01520324|Primary|Intraepithelial Neoplasia (IN) Detection Rate (False Negative Findings)|The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.|During colonscopy (usually <15 min) and subsequent histological analysis||||percentage of false neg. findings of IN|||Number
2666786|NCT01520909|Secondary|Number of Participants With a Change in Visual Acuity Since Baseline at Week 24 of Part 2|The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Change in visual acuity results are presented as No Change, NCS, Improvement, and Worsening since Baseline. The Baseline value was obtained at the Screening Visit.|Baseline and Week 24 of Part 2|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.|||Participants|||Number
2666787|NCT01520909|Secondary|Number of Participants With a Change in Visual Acuity Since Baseline at Week 12 of Part 1|The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Change in visual acuity results are presented as No (no change from Baseline), Not Clinically Significant (NCS), Improvement, and Worsening since Baseline. The Baseline value was obtained at the Screening Visit.|Baseline and Week 12 of Part 1|Safety Population|||Participants|||Number
2666788|NCT01520909|Secondary|Number of Participants With Vital Sign Data Falling Outside the Reference Ranges (RR) at the Indicated Visit During Part 2|Vital sign measurements were taken before any blood draw and included systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate(HR). The number of participants are reported with vital sign data falling outside the standard RR as reference range high(RRH) and reference range low(RRL) from SCR up to Week 24 of Part 2 and from Follow-up Week 1 to Week 4. RR for Blood Pressure(mmHg) are read as: Lower Limit of Normal, Normal Range, Upper Limit of Normal. For Ages 1 to 5 years (yrs) ranges are SBP <85, 85 to 115, >115; DBP <45, 45 to70, >70. Ages 6 to 11 yrs: SBP <85, 85 to 120, >120; DBP <50, 50 to 75, >75. Ages 12 to 17 yrs: SBP <95, 95 to 135, >135; DBP <55, 55 to 85, >85. RR for HR (bpm) are ages 1 to < 3 yrs: <90, 90 to 140, >140; ages 3 to < 5 yrs: <75, 75 to 130, >130, ages 5 to < 8yrs: <65, 65 to 115, >115; ages 8 to < 12yrs: <55, 55 to 110, >110; and ages 12 to 18 yrs: <55, 55 to 110, >110.|From Week 1 up to Week 24 of Part 2 and Follow-up Week 1 to Week 4 (up to Week 41)|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Participants|||Number
2666789|NCT01520909|Secondary|Number of Participants With Vital Sign Data Falling Outside the Reference Ranges (RR) at the Indicated Visit During Part 1|Vital sign measurements were taken before any blood draws and included systolic blood pressure(SBP), diastolic blood pressure(DBP), and heart rate(HR). The number of participants are reported with vital sign data falling outside the standard reference ranges RR as reference range high(RRH) and reference range low(RRL). The Baseline(BL) value is defined as the value taken at Day 1 or if missing, the latest non-missing SCR value. RR for Blood Pressure (mmHg) are read as: Lower Limit of Normal, Normal Range, Upper Limit of Normal. For Ages 1 to 5 years (yrs) ranges are SBP <85, 85 to 115, >115; DBP <45, 45 to70, >70. Ages 6 to 11 yrs: SBP <85, 85 to 120, >120;, DBP <50, 50 to 75, >75. Ages 12 to 17 yrs: SBP <95, 95 to 135, >135; DBP <55, 55 to 85, >85. RR for HR(bpm) are ages 1 to < 3 yrs: <90, 90 to 140, >140; ages 3 to < 5 yrs: <75, 75 to 130, >130, ages 5 to < 8yrs: <65, 65 to 115, >115; ages 8 to < 12yrs: <55, 55 to 110, >110; and ages 12 to 18 yrs: <55, 55 to 110, >110.|From Screening (SCR) up to Week 13 of Part 1|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).|||Participants|||Number
2666790|NCT01520909|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During Part 2|Hematology parameters were summarized according to the NCI CTCAE, version 4.0: G0, none, G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: leukocytes, neutrophils, hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), and lymphocytes (decreased). For participants randomized to Placebo in Part 1, the BL value for Part 2 is defined as the value taken at Week 13 of Part 1. For participants randomized to Eltrombopag in Part 1, the BL value is defined as the value taken on Day 1 or, if missing, the latest non-missing Screening value. For participants who do not have both a Screening and Day 1 value, the Screening or Day 1 value will be used as BL. The maximum post-BL toxicity grade includes any scheduled or unscheduled post-BL assessment.|From Baseline up to Week 24 of Part 2 and Follow-up Weeks 1 to 4 (up to Study Week 41)|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.|||Participants|||Number
2666791|NCT01520909|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology Parameters at Any Time Post-Baseline During Part 1|Hematology parameters were summarized according to the NCI CTCAE, version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: leukocytes, neutrophils, hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), and lymphocytes (decreased). The Baseline value is defined as the value taken at Day 1 or, if missing, the latest non-missing Screening value. The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during Part 1.|From Baseline up to Week 13 of Part 1|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).|||Participants|||Number
2666792|NCT01520909|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During Part 2|Clinical chemistry parameters were summarized according to the NCI CTCAE, version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Clinical chemistry parameters included: AST, ALP, total bilirubin, albumin, ALT, and creatinine. For participants randomized to Placebo in Part 1, the BL value for Part 2 is defined as the value taken at Week 13 of Part 1. For serum creatinine, the value taken at Week 13 of Part 1 will be used as BL. For participants randomized to Eltrombopag in Part 1, the BL value is defined as the value taken on Day 1 or, if missing, the latest non-missing Screening value. For serum creatinine, due to the variations in creatinine, the average of the Screening and the Day 1 values will be used as BL. For participants who do not have both a Screening and Day 1 value, the Screening or Day 1 value will be used as BL. The maximum post-BL toxicity grade includes any scheduled or unscheduled post-BL assessment.|From Baseline (BL) of Part 2 through Follow-up|Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.|||Participants|||Number
2668946|NCT01499810|Secondary|Change in Nighttime Diastolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 12 months||||mmHg||Standard Deviation|Mean
2666793|NCT01520909|Secondary|Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During Part 1|Clinical chemistry parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: Grade 0 (G0), none; Grade 1 (G1), mild; Grade 2 (G2), moderate; Grade 3 (G3), severe; Grade 4 (G4), life-threatening or disabling. Clinical chemistry parameters included: aspartate amino transferase (AST), alkaline phosphatase (ALP), total bilirubin, albumin, alanine amino transferase (ALT), prothrombin international normalized ratio (PT INR), activated partial thromboplastin time (APTT), and creatinine. The Baseline value is defined as the value taken at Day 1 or, if missing, the latest non-missing Screening value. For serum creatinine, due to the variations in creatinine, the average of the Screening and the Day 1 values will be used as Baseline. The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during Part 1.|From Baseline up to Week 13 of Part 1|Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).|||Participants|||Number
2666794|NCT01520909|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening; requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Day 1 of Part 2 up to Week 24 of Part 2 + 1 day|Safety Population|||Participants|||Number
2666795|NCT01520909|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1|An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.|From Day 1 of Treatment up to Week 13 of Part 1+ 1 day|Safety Population: all participants who received at least one dose of the investigational product|||Participants|||Number
2666796|NCT01520909|Secondary|Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the WHO Bleeding Scale During Part 2|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO Grades were dichotomized into the following categories: no bleeding = Grade 0; any bleeding = Grade 1 to 4; no clinically significant bleeding = Grade 0 to 1; clinically significant bleeding = Grade 2 to 4.|From Baseline of Part 2 through Follow-up|ITT Population. Only those participants who entered into Part 2 open-label Eltrombopag only phase were analyzed. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||Participants|||Number
2666797|NCT01520909|Secondary|Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2|Rescue treatment was defined as either a new immune (idiopathic) thrombocytopenic purpura (ITP) medication, an increase in the dose of a concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy.|From Baseline up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.|||Participants|||Number
2666798|NCT01520909|Secondary|Number of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During Part 2 Without Requiring Subsequent Rescue Therapy|Participants who discontinued or had a sustained reduction of a baseline immune (idiopathic) thrombocytopenic purpura (ITP) medication during the 24 weeks of Part 2 (Open-Label Period) and without requiring subsequent rescue therapy. For participants randomized to placebo in Part 1, Baseline is defined as Week 13 of Part 1. For participants randomized to eltrombopag in Part 1, Baseline is defined as Day 1 of Part 1. A sustained reduction was defined as a reduction for 4 weeks or more.|From Baseline up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) and taking an ITP medication at Baseline were analyzed.|||Participants|||Number
2666799|NCT01520909|Secondary|Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During Part 2|The maximum duration for which a participant continuously maintained a platelet count of >=50 Gi/L was calculated and summarized for the 24 weeks of eltrombopag dosing (Part 2). Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If the participant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day.|From Baseline up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.|||Weeks||Standard Deviation|Mean
2666800|NCT01520909|Secondary|Number of Weeks in Which Participants Achieved a Platelet Count >=50 Gi/L, Between Weeks 4 and 24 of Part 2|Platelet response was analyzed after Week 4 for the eltrombopag-only period to allow participants who had been randomized to placebo in the Randomized Period time to escalate to their optimal dose of eltrombopag. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If the participant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day.|From Week 4 up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.|||Weeks||Standard Deviation|Mean
2666801|NCT01520909|Secondary|Number of Participants Who Achieved a Platelet Count >=50 Gi/L at Any Time During Part 2|Participants who achieved a platelet count >=50 Gi/L at any time during Part 2 (up to Week 24) were reported.|From Baseline up to Week 24 of Part 2|ITT Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.|||Participants|||Number
2669418|NCT01495858|Secondary|Time to Rescue Medication|If rescue medication was taken by a subject for pain, then the time of rescue medication administration was recorded|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Median
2666802|NCT01520909|Secondary|Number of Participants With Any Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 1|The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0=no bleeding; Grade 1=petechiae; Grade 2=mild blood loss; Grade 3=gross bleeding; Grade 4=debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. Baseline was defined as the Day 1 assessment or the latest possible screening assessment.|From Baseline through Follow-up of Part 1|ITT Population. Only those participants that did not enroll in Part 2 were analyzed during the follow-up visits. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles).|||Participants|||Number
2666803|NCT01520909|Secondary|Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 1|Rescue treatment is defined as either a new immune (idiopathic) thrombocytopenic purpura (ITP) medication, an increase in the dose of a concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy.|From Baseline up to Week 12 of Part 1|ITT Population|||Participants|||Number
2666804|NCT01520909|Secondary|Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the First 12 Weeks of Part 1|The maximum duration for which a participant continuously maintained a platelet count >=50 Gi/L was calculated and summarized for the first 12 weeks of Part 1. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a participant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day.|From Baseline up to Week 12 of Part 1|ITT Population|||Weeks||Standard Deviation|Mean
2666805|NCT01520909|Secondary|Weighted Mean Platelet Count|"The weighted mean platelet count is defined as the area under the platelet-time curve divided by the duration of the study (12 weeks). Weighted mean platelet counts from baseline to week 12 of the randomized period was compared between placebo and eltrombopag using an analysis of covariance model (ANCOVA) adjusting for baseline platelet count and age cohort. For each subject the area between two adjacent visits with platelet counts was calculated. The area was calculated for all pairs of adjacent visits starting at Day 1 of randomized period and then the total sum of all the areas was divided by the total duration of time during the randomized period. For each subject, this method calculates an 'average' platelet count and it allows the possibility that subjects may have had different number of assessments during different times relative to baseline."|Baseline and Week 12 of Part 1|ITT Population. Only those participants with a value at Baseline and post-Baseline were analyzed.|||Gi/L||Standard Deviation|Mean
2666806|NCT01520909|Secondary|Number of Participants Achieving a Platelet Count >=50 Gi/L at Any Time During the First 6 Weeks of Part 1|Participants who achieved a platelet count >=50 Gi/L at any time during the first 6 weeks of Part 1 were reported.|From Baseline up to Week 6 of Part 1|ITT Population|||Participants|||Number
2666807|NCT01520909|Secondary|Number of Participants Achieving a Platelet Count >=50 Gi/L at Any Time During the First 12 Weeks of Part 1|Participants who achieved a platelet count >=50 Gi/L at any time during the first 12 weeks of Part 1 were reported.|From Baseline up to Week 12 of Part 1|ITT Population|||Participants|||Number
2666808|NCT01520909|Secondary|Percentage of Responders|Percentage of participants who responded (defined as platelet count >= 50 Gi/L in absence of rescue) at least once up to week 12 of Part 1 (Odds of achieving a platelet count >=50 Gi/L during the first 12 weeks of Part 1)|From Week 1 up to Week 12 of Part 1|ITT Population|||Percentage of participants|||Number
2666809|NCT01520909|Primary|Number of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) for at Least 6 Out of 8 Weeks, Between Weeks 5 and 12 of Part 1|Participants who achieved a platelet count >=50 Gi/L for at least 6 out of 8 weeks, between Weeks 5 and 12 of Part 1, were reported.|From Week 5 up to Week 12 of Part 1|Intent-to-Treat (ITT) Population: all randomized participants. The ITT Population was the primary population used for assessing efficacy.|||Participants|||Number
2666810|NCT01520727|Secondary|Time to Cmax (Tmax)||pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose||||hours||Full Range|Median
2666811|NCT01520727|Secondary|Cmax - BIA 9-1067|Cmax - maximum plasma concentration|pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose||||ng/mL||Standard Deviation|Mean
2666812|NCT01520727|Primary|Adverse Events (AEs)|Safety was evaluated from the number of reported adverse events (AEs)|7 weeks||||Number of Adverse Events|||Number
2666813|NCT01520714|Primary|Evidence of Change in Threshold of >1 Volt With Posture Changes||6 months|Early termination leading to small numbers of subjects; Non-efficacy of treatment leading to no data summary and analysis.||||||
2666814|NCT01520558|Secondary|Efficacy|Determine relapse free survival (RFS) and overall survival (OS) following infusion with CNDO-109-Activated Allogeneic Natural Killer Cells.|from the date of documented CR until the first documented progression date or until day 360 post dose whichever is sooner|||||||
2666815|NCT01520558|Secondary|Additional Safety Profile Beyond MTD|Characterize the safety profile of CNDO-109-Activated Allogeneic Natural Killer Cells infusion after preparative therapy by measurement of adverse events, safety labs, vital signs, bone marrow biopsy/aspiration and physical examination.|up to 360 days post dose|||||||
2666816|NCT01520558|Primary|Define MTD|The primary objective is to define the maximum tolerated dose (MTD), or the maximum tested dose where multiple dose-limiting toxicities (DLTs) are not observed, of CNDO-109-Activated Allogeneic Natural Killer Cells infused after preparative chemotherapy, administered to patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1) at the time of enrollment and are considered to be at high risk for recurrence. The MTD outcome measure is presented as number of participants with DLTs.|up to 30 days post dose||||Participants|||Count of Participants
2666817|NCT01520532|Secondary|Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject.|The number of subjects with pulmonary vein isolation (PVI) at the end of ablation procedure. This will characterize if use of best practices during PVAC ablation negatively affects acute efficacy.|Day 1 (End of Procedure)|All subjects who underwent ablation and post-procedure MRI.|||participants|||Number
2666820|NCT01520519|Primary|Number of Participants With a Response|Over all Response = complete remission (CR) + partial remission (PR). Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; positive or negative minimal residual disease (MRD); Partial remission (PR), defined as ≥ 50% fall in lymphocyte count, ≥ 50% reduction in lymphadenopathy or ≥ 50% reduction in liver or spleen, together with improvement in peripheral blood counts|7 months|1 participant was not evaluable for response|||Participants|||Count of Participants
2666821|NCT01520519|Primary|Progression Free Survival (PFS)|Progression free survival defined as the time interval from treatment to progressive disease or death, whichever happens earlier. Participants in complete remission (CR), partial remission (PR) or stable disease (SD) are all counted as progression-free. Survival or times to progression functions estimated using the Kaplan-Meier method.|up to 50 months|1 participant was not evaluable for response|||Months||Full Range|Median
2666822|NCT01520506|Secondary|Renal Denervation Procedure Effectiveness|Procedural Effectiveness, defined as rate of Office Systolic Blood Pressure (SBP) reduction > 10 mmHg at 6 months compared to baseline|From baseline to 6 months||||percentage of participants|||Number
2666823|NCT01520506|Secondary|Chronic Procedural Safety|Chronic Procedural Safety, defined as the overall rate of Serious Adverse Events and Adverse Device Effects at 6 months|6 months||||percentage of participants|||Number
2666824|NCT01520506|Primary|Acute Procedural Safety|"Acute Procedural Safety, defined as the overall rate of Serious Adverse Events (SAE's) and adverse device effects at discharge:~SAE's related to groin and vascular access complications, and~SAE's related to renal artery injury."|One Week||||percentage of participants|||Number
2666825|NCT01520454|Secondary|Phosphorylation of STAT3 Pathways Downstream of Leptin After Lipid Administration|Intracellular signaling mechanisms downstream of leptin (particularly the STAT3 pathway) in response to lipid administration as represented by phosphorylation (pSTAT3).|Baseline to 6 hours|The analysis unfortunately can not be performed due to technical reasons as STAT3 was not able to be measured in the samples/not enough volume was left to perform the appropriate tests after trouble-shooting.||||||
2666826|NCT01520454|Secondary|Change in Circulating Adiponectin Levels|The Adiponectin AUC was calculated from baseline to six hours|Baseline to 6 hours|Areas Under the Curve are presented|||ng*min/ml||Standard Deviation|Mean
2666827|NCT01520454|Secondary|Change in Circulating Leptin Levels|The Leptin AUC was calculated from baseline to six hours|Baseline to 6 hours|Areas Under the Curve are presented|||ng*min/ml||Standard Deviation|Mean
2666828|NCT01520454|Secondary|Change in Circulating Insulin Levels|The Insulin AUC was calculated from baseline to six hours|Baseline to 6 hours|Areas Under the Curve are presented|||mU*min/ml||Standard Deviation|Mean
2666829|NCT01520454|Secondary|Change in Circulating Glucose Levels|The Glucose AUC was calculated from baseline to six hours|Baseline to 6 hours|Areas Under the Curve are presented|||mg*min/dl||Standard Deviation|Mean
2666830|NCT01520454|Primary|Change in Circulating Peptide Tyrosine Tyrosine (PYY) Levels|The PYY AUC was calculated from baseline to six hours|Baseline to 6 hours|Areas under the curve are presented|||pg*min/ml||Standard Deviation|Mean
2666831|NCT01520454|Primary|Change in Circulating Ghrelin Levels|The Ghrelin AUC was calculated from baseline to six hours|Baseline to 6 hours|Areas under the curve are presented|||pg*min/ml||Standard Deviation|Mean
2666832|NCT01520454|Primary|Change in Circulating Gastric Inhibitory Polypeptide (GIP) Levels|The GIP AUC fwas calculated from baseline to six hours|Baseline to 6 hours|Areas under the curve are presented|||pM*min/ml||Standard Deviation|Mean
2666833|NCT01520454|Primary|Change in Circulating Glucagon-like Peptide-1 (GLP-1) Levels|The GLP-1 area under the curve (AUC) was calculated from baseline to six hours|Baseline to 6 hours|Areas under the curve are presented|||pM*min||Standard Deviation|Mean
2666834|NCT01520402|Primary|Median Cumulative Warfarin Dose Requirement by Genotype Category (CYP2C9 and VKORC1 -1639 G>A Combination)|Subjects were also grouped into four categories based on CYP2C9 and VKORC1 genotype profile: Group 1 (CYP2C9 wild-type and VKORC1 wild-type), Group 2 (CYP2C9 wild-type and VKORC1 variant), Group 3 (CYP2C9 variant and VKORC1 wild-type), and Group 4 (CYP2C9 variant and VKORC1 variant). Median cumulative warfarin dose requirement was determined for each genotype category.|2-30 days|Of the 35 subjects enrolled, 30 were included in the study as above.|||milligrams||Inter-Quartile Range|Median
2666835|NCT01520402|Secondary|Explained Variation in Combined Therapeutic Warfarin Dose Models|The proportion of variance (R^2) explained by each predictor was calculated using multivariate regression analysis and adjusted for age, gender and reported race, with outcome values logarithmically transformed. The study was powered to detect R^2 > 20%, and significance was accepted at p<0.05.|average of 2 - 30 days|Of the 35 subjects enrolled, 30 completed the study as described above.|||proportion of variance|||Number
2666836|NCT01520402|Secondary|Median Cumulative Warfarin Dose Requirements by CYP4F2 Genotype Status|To assess the effect of CYP4F2 genotype variants on the anticoagulant response to warfarin.|average of 2 - 30 days|Of 35 subjects were enrolled, 30 were included as listed above.|||milligrams||Inter-Quartile Range|Median
2666837|NCT01520402|Primary|Median Cumulative Therapeutic Warfarin Dose (Milligrams)Requirements by Genotype|To assess the effect of genotype variants (CYP2C9 and VKORC1 -1639 G>A) on the anticoagulant response to warfarin, the primary outcome was the cumulative dose required to achieve an INR value in the usual clinical therapeutic range (>2.0) for two consecutive days.|average of 2 - 13 days|Of the 35 subjects enrolled, 30 were included in the study as listed above.|||milligrams||Inter-Quartile Range|Median
2666838|NCT01520363|Other Pre-specified|Change in Seizure Frequency, Pre-and Post-Intervention, 5-10 Year Age Group|Change in Frequency of seizures baseline to follow-up for children aged 5-10 years|Baseline evaluation and at the end of the 3 month study||||seizure count||Standard Deviation|Mean
2666839|NCT01520363|Other Pre-specified|Change in Seizure Frequency, Pre- and Post-Intervention, 0-4 Year Age Group|Change in Frequency of seizure count baseline to follow-up for children aged 0-4 years|Baseline evaluation and at the end of the 3 month study|Children enrolled at baseline aged 0 to 4 years|||seizure count||Standard Deviation|Mean
2668947|NCT01499810|Secondary|Change in Nighttime Systolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 12 months||||mmHg||Standard Deviation|Mean
2666840|NCT01520363|Other Pre-specified|Change in PedsQL Physical Functioning Subscale Score, Pre- and Post-Intervention|Pediatric Quality of Life Inventory (PedsQL version 4). Physical Functioning subscale. 5-point Likert scale from 0 (Never) to 4 (Almost always); Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores indicate better Health Related Quality of Life (QOL).|Initial evaluation and at the end of the 3 month study|MECP2 Mutation positive participants who are fast metabolizers were randomized to placebo or DM at baseline. Two participants in the baseline DM group were noncompliant and removed from the study at baseline. At 3 months, 22 were analyzed in the DM study drug group and 25 in the placebo group due to incomplete data.|||score on a scale||Standard Deviation|Mean
2666841|NCT01520363|Other Pre-specified|Change in PedsQL Emotional Functioning Subscale Score, Pre- and Post-Intervention|Pediatric Quality of Life Inventory (PedsQL version 4). Emotional Functioning subscale. 5-point Likert scale from 0 (Never) to 4 (Almost always); Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores indicate better Health Related Quality of Life (QOL).|Baseline evaluation and at the end of the 3 month study|MECP2 Mutation positive participants who are fast metabolizers were randomized to placebo or DM at baseline. Two participants in the baseline DM group were noncompliant and removed from the study at baseline. At 3 months, 22 were analyzed in the DM study drug group and 25 in the placebo group due to incomplete data.|||score on a scale||Standard Deviation|Mean
2666842|NCT01520363|Other Pre-specified|Change in PedsQL Social Functioning Subscale Score, Pre- and Post-Intervention|Pediatric Quality of Life Inventory (PedsQL version 4). Social Functioning subscale. 5-point Likert scale from 0 (Never) to 4 (Almost always); Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores indicate better Health Related Quality of Life (QOL).|Baseline and at the end of the 3 month trial|MECP2 Mutation positive participants who are fast metabolizers were randomized to placebo or DM at baseline. Two participants in the baseline DM group were noncompliant and removed from the study at baseline. At 3 months, 22 were analyzed in the DM study drug group and 25 in the placebo group due to incomplete data.|||score on a scale||Standard Deviation|Mean
2666843|NCT01520363|Other Pre-specified|Change in PedsQL Total Score, Pre- and Post-Intervention|Pediatric Quality of Life Inventory (PedsQL version 4) total score. Each item is rated on a 5-point Likert scale from 0 (Never) to 4 (Almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The Total Score is the sum of all the items over the number of items answered on all the Scales. Higher scores indicate better HRQOL.|Baseline evaluation and at the end of the 3 month study|MECP2 Mutation positive participants who are fast metabolizers were randomized to placebo or DM at baseline. Two participants in the baseline DM group were noncompliant and removed from the study at baseline. At 3 months, 22 were analyzed in the DM study drug group and 25 in the placebo group due to incomplete data.|||score on a scale||Standard Deviation|Mean
2666844|NCT01520363|Other Pre-specified|Change in PedsQL School Functioning Subscale Score, Pre- and Post-Intervention|Pediatric Quality of Life Inventory (PedsQL version 4). School Functioning subscale. 5-point Likert scale from 0 (Never) to 4 (Almost always); Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. Higher scores indicate better Health Related Quality of Life (QOL).|Baseline evaluation and at the end of the 3 month study|MECP2 Mutation positive participants who are fast metabolizers were randomized to placebo or DM at baseline. Two participants in the baseline DM group were noncompliant and removed from the study at baseline. At 3 months, 22 were analyzed in the DM study drug group and 25 in the placebo group due to incomplete data.|||score on a scale||Standard Deviation|Mean
2666845|NCT01520363|Secondary|Change in Rett Syndrome Behavior Questionnaire Score, Pre- and Post-Intervention|The Rett Syndrome Behavior Questionnaire (RSBQ) total score was assessed. The total score ranges from 0 to 90, with 0 exhibiting no Rett syndrome related symptoms and 90 showing the greatest amount of symptoms (worse outcome).|Initial evaluation and at the end of the 3 month study||||units on a scale||Standard Deviation|Mean
2666846|NCT01520363|Secondary|Change in Ghuman-Folstein Screen for Social Interaction (SSI) Score, Pre- and Post-Intervention.|"The Ghuman-Folstein Screen for Social Interaction (SSI) assesses the change in behavior and temperament dysregulation as a total score.~The score ranges from 0-162, with 0 being most Impaired /has the strongest autism features and 162 having no impairment/no autism features."|Initial evaluation and at the end of the 3 month study. The test lasts 45 minutes||||units on a scale||Standard Deviation|Mean
2666847|NCT01520363|Secondary|Change in VABS:Communication Domain Scores, Pre- and Post-Intervention|Vineland Adaptive Behavior Scales (VABS)-II Communication Domain Scores. The Communication Domain evaluates the receptive, expressive, and written communication skills of the child. Critical behaviors in each Subdomain item are rated as 2=Usually, 1=Sometimes or Partially, 0= Seldom or Never. Communication Domain raw scores range from: Minimum=0 to Maximum=198. A higher score is a better outcome.|Baseline and at the end of the 3 month trial|52 MECP2 Mutation positive participants who are fast metabolizers were enrolled at baseline. Two participants in the baseline DM group were noncompliant and removed from the study. At 3 months 22 were analyzed in the DM study drug group and 25 in the placebo group due to incomplete data.|||score on a scale||Standard Deviation|Mean
2666848|NCT01520363|Secondary|Change in VABS: Socialization Domain Scores, Pre- and Post-Intervention|Vineland Adaptive Behavior Scales-II (VABS): Socialization Domain. Critical behaviors are scored on a Likert scale from 2=Usually, 1=Sometimes or Partially, 0= Seldom or Never. Socialization Domain raw scores range from: Minimum=0 to Maximum=152. A higher score is a better outcome.|Baseline and at the end of the 3 month trial|MECP2 Mutation positive participants who are fast metabolizers were randomized to placebo or DM at baseline. Two participants in the baseline DM group were noncompliant and removed from the study at baseline. At 3 months 22 were analyzed in the DM study drug group and 25 in the placebo group due to incomplete data.|||score on a scale||Standard Deviation|Mean
2666859|NCT01520324|Primary|Intraepithelial Neoplasia (IN) Detection Rate (True Negative Findings)|The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.|During colonscopy (usually <15 min) and subsequent histological analysis||||percentage of true neg. findings of IN|||Number
2666849|NCT01520363|Secondary|Change in VABS:Daily Living Skills Domain Scores, Pre- and Post-Intervention|Vineland Adaptive Behavior Scales-II (VABS): Daily Living Skills Domain individual items are scored on a Likert scale from 2=Usually, 1=Sometimes or Partially, 0= Seldom or Never. The Daily Living Skills Domain measures personal behavior as well as domestic and community interaction skills. Daily Living Skills Domain raw scores range from Minimum=0 to Maximum=218.|Baseline and at the end of the 3 month trial|52 MECP2 Mutation positive participants who are fast metabolizers were enrolled in the study. Two participants in the baseline DM group were noncompliant and removed from the study at baseline. At 3 months 22 were analyzed in the DM study drug group and 25 in the placebo group due to incomplete data.|||score on a scale||Standard Deviation|Mean
2666850|NCT01520363|Secondary|Change in VABS: Motor Skills Domain Scores, Pre- and Post-Intervention|Vineland Adaptive Behavior Scales-II (VABS): Motor Skills Domain Scores individual items are scored on a Likert scale from 2=Usually, 1=Sometimes or Partially, 0= Seldom or Never. Motor Skills Domain raw scores range from: Minimum=0 to Maximum=100. A higher score is a better outcome.|Baseline evaluation and at the end of the 3 month study|MECP2 Mutation positive participants who are fast metabolizers were randomized to placebo or DM at baseline. Two participants in the baseline DM group were noncompliant and removed from the study at baseline. At 3 months 22 were analyzed in the DM study drug group and 25 in the placebo group due to incomplete data.|||score on a scale||Standard Deviation|Mean
2666851|NCT01520363|Primary|Change in Mullen, Expressive Language Sub-scale Scores, Pre- and Post-Intervention|The Mullen Scales of Early Learning (MULLEN) Expressive Language scale raw scores range from Minimum=0 to Maximum=50. A higher score is a better outcome. Age equivalents from 1 month to 70 months can be computed for each subscale separately.|Baseline and 3 months|Mutation positive participants who are fast metabolizers at baseline. 2 were noncompliant and removed from the study drug group. At 3 months 22 were analyzed in the study drug group and 25 in the placebo group due to incomplete data.|||score on a scale||Standard Deviation|Mean
2666852|NCT01520363|Primary|Change in Mullen; Receptive Language Subscale Scores, Pre- and Post-Intervention|The Mullen Scales of Early Learning (MULLEN) Receptive Language scale raw scores range from Minimum=0 to Maximum=50. A higher score is a better outcome. Age equivalents from 1 month to 70 months can be computed for each subscale separately.|Baseline and 3 months|Mutation positive participants who are fast metabolizers at baseline. 2 were noncompliant and removed from the study drug group. At 3 months 22 were analyzed in the study drug group and 25 in the placebo group due to incomplete data.|||score on a scale||Standard Deviation|Mean
2666853|NCT01520363|Primary|Change in Mullen; Fine Motor Sub-scale Scores, Pre- and Post-Intervention|The Mullen Scales of Early Learning (MULLEN) Fine motor scale raw scores range from Minimum=0 to Maximum=49. A higher score is a better outcome. Age equivalents from 1 month to 70 months can be computed for each subscale separately.|Baseline and 3 months|Mutation positive participants who are fast metabolizers at baseline. 2 were noncompliant and removed from the study drug group. At 3 months 22 were analyzed in the study drug group and 25 in the placebo group due to incomplete data.|||score on a scale||Standard Deviation|Mean
2666854|NCT01520363|Primary|Change in Mullen; Visual Reception Sub-scale Scores, Pre- and Post-Intervention|The Mullen Scales of Early Learning (MULLEN) Visual reception subscale raw scores range from Minimum=0 to Maximum=50. A higher score is a better outcome. Age equivalents from 1 month to 70 months can be computed for each subscale separately.|Initial evaluation and at the end of the 3 month trial|Mutation positive participants who are fast metabolizers at baseline. 2 were noncompliant and removed from the study drug group. At 3 months 22 were analyzed in the study drug group and 25 in the placebo group due to incomplete data.|||score on a scale||Standard Deviation|Mean
2666855|NCT01520324|Secondary|Bowel Cleansing Quality Evaluated by Boston Bowel Preparation Scale After Intake of Bowel Cleansing Formulation and of a Total Dose of 200 mg of Methylene Blue MMX Tablets Administered During and at the End of the Intake of the Bowel Cleansing Formulation|"The Boston Bowel Preparation Score (BBPS) was used to rate colon cleansing quality. Each of the following 3 regions was rated: right, mid and rectosigmoid colon. The following 4-point scale (0-3) was used.~0 - unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared~- portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid~- minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well~- entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.~Each region of the colon received a segment score from 0 to 3 and these segment scores were summed for a total BBPS score ranging from 0 to 9. Therefore, the maximum BBPS score for a perfectly clean colon, without any residual liquid, is 9 and the minimum BBPS score for an unprepared colon is 0."|During colonscopy (usually <15 min)||||Boston bowel preparation scale (BBPS)||Standard Deviation|Mean
2666856|NCT01520324|Secondary|The Mucosal Staining Efficacy of Methylene Blue MMX® Tablets After a Total Oral Dose of 200 mg Administered During and at the End of the Intake of the Bowel Cleansing Preparation.|"The mucosal staining efficacy of Methylene Blue MMX® tablets was assessed in all 4 examined colonic regions (ascending, transverse and descending colon and rectosigmoid).~The staining efficacy in each colon region was assessed scoring the observed staining percentage as reported below:~0. no staining~traces (poor traces in colon mucosa)~detectable (at least the 25% of colon mucosa is stained)~acceptable (at least the 50% of colon mucosa is stained)~good (at least the 75% of colon mucosa is stained)~overstained (the 100% of the colon mucosa is over stained)"|During colonscopy (usually <15 min) and subsequent histological analysis||||Staining score||Standard Deviation|Mean
2666857|NCT01520324|Secondary|The Extent and Severity of the Inflamed Mucosa|"The inflammation conditions of the mucosa were evaluated during the colonoscopy and, afterwards, in the bioptic specimens.~Rachmilewitz EI and Saverymuttu scores were used to assess inflammation. Rachmilewitz's scoring system for endoscopic index (EI) measures granulation scattering reflected light, vascular pattern, vulnerability of mucose and mucosal damage on a scoring scale of 0 to 4 from normal to damaged.~Saverymuttu's scoring system for enteric specimens assesses disease activity in the bowel by rating histological changes in enterocytes, crypts, lamina propria mononuclear cells and lamina propria neutrophils.~The average score for histological changes in individual biopsy specimens was summed and converted into a grade from 1 to 4, increasing in severity."|During colonscopy (usually <15 min) and subsequent histological analysis||||Rachmilewitz and Saverymuttu scores||Standard Deviation|Mean
2666860|NCT01520324|Primary|Intraepithelial Neoplasia (IN) Detection Rate (False Positive Findings)|The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.|During colonscopy (usually <15 min) and subsequent histological analysis||||percentage of false pos. findings of IN|||Number
2666861|NCT01520324|Primary|Intraepithelial Neoplasia (IN) Detection Rate (True Positive Findings)|The rate of intraepithelial neoplasiae detection in the whole colon is summarised along with the number and percentage of subjects affected. The number and percentage of false and true negative and of false and true positive findings of intraepithelial neoplasiae are also listed.|During colonscopy (usually <15 min) and subsequent histological analysis||||percentage of true pos. findings of IN|||Number
2666862|NCT01520324|Primary|Detected Intraepithelial Neoplasia|Rate of intraepithelial neoplasiae detection in the whole colon.|During colonscopy (usually <15 min) and subsequent histological analysis||||Number of detected IN||Standard Deviation|Mean
2666863|NCT01520207|Primary|Efficacy of Mannitol Administration in Reducing the Frequency of Intra-dialytic Hypotension (Decline in Systolic Blood Pressure) During the First Three Hemodialysis Initiation Sessions.|SBP decline during first three sessions|First three hemodialysis sessions (5 days)|SBP decline|||mmHg||Standard Deviation|Mean
2666864|NCT01520038|Secondary|Number of Participants With Adverse Events|Late toxicty|later than 90 days from start of radiation therapy||||Participants|||Count of Participants
2666865|NCT01520038|Primary|Number of Participants With Adverse Events|Applies to Both Proton and IMRT|within 90 days of radiation therapy||||Participants|||Count of Participants
2666866|NCT01520038|Primary|Number of Participants With Adverse Events|Applies to Proton only|withion 14 days of estimated date of treatment completion||||Participants|||Count of Participants
2666867|NCT01519960|Secondary|Change From Baseline in Quantitative HBsAg Level in Group C|The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.|Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|Safety Population.|||log10 IU/mL||Standard Deviation|Mean
2666868|NCT01519960|Secondary|Quantitative HBsAg Level in Group C|Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|Safety Population.|||log10 IU/mL||Standard Deviation|Mean
2666869|NCT01519960|Secondary|Change From Baseline in Quantitative HBeAg Level in Group C|The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL.|Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."|||log10 PEIU/mL||Standard Deviation|Mean
2666870|NCT01519960|Secondary|Quantitative HBeAg Level in Group C|Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 PEIU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||log10 PEIU/mL||Standard Deviation|Mean
2666871|NCT01519960|Secondary|Change From Baseline in Quantitative Serum ALT Level in Group C|The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).|Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||factor of ULN||Standard Deviation|Mean
2666872|NCT01519960|Secondary|Change From Baseline in Quantitative HBsAg Level in Groups A and B|The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.|Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."|||log10 IU/mL||Standard Deviation|Mean
2666873|NCT01519960|Secondary|Quantitative HBsAg Level in Groups A and B|Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||log10 IU/mL||Standard Deviation|Mean
2666874|NCT01519960|Secondary|Change From Baseline in Quantitative HBeAg Level in Groups A and B|The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL.|Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|"ITT Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."|||log10 PEIU/mL||Standard Deviation|Mean
2666875|NCT01519960|Secondary|Quantitative HBeAg Level in Groups A and B|Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 Paul Ehrlich Institute units per milliliter (PEIU/mL).|Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)|ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||log10 PEIU/mL||Standard Deviation|Mean
2666876|NCT01519960|Secondary|Change From Baseline in Quantitative Serum ALT Level in Groups A and B|The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).|Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||factor of ULN||Standard Deviation|Mean
2668948|NCT01499810|Secondary|Change in Daytime Diastolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 12 months||||mmHg||Standard Error|Mean
2666877|NCT01519960|Secondary|Percentage of Participants With HBeAg Seroconversion at 24 Weeks After EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2666878|NCT01519960|Secondary|Change From Baseline in Weight for Age Z-Score in Group C|The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.|Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||standard deviations||Standard Deviation|Mean
2666879|NCT01519960|Secondary|Change From Baseline in Height for Age Z-Score in Group C|The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.|Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)|Safety Population.|||standard deviations||Standard Deviation|Mean
2666880|NCT01519960|Secondary|Change From Baseline in Weight for Age Z-Score in Groups A and B|The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.|Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."|||standard deviations||Standard Deviation|Mean
2666881|NCT01519960|Secondary|Change From Baseline in Height for Age Z-Score in Groups A and B|The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.|Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."|||standard deviations||Standard Deviation|Mean
2666882|NCT01519960|Secondary|Percentage of Participants With >15% Drop in Weight Percentile for Age in Group C|The percentage of participants with >15% drop in weight percentile for age from Baseline to each visit was reported.|Weeks 30, 36; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants|||Number
2666883|NCT01519960|Secondary|Percentage of Participants With >15% Drop in Height Percentile for Age in Group C|The percentage of participants with >15% drop in height percentile for age from Baseline to each visit was reported.|Weeks 12, 24, 48; FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants|||Number
2666884|NCT01519960|Secondary|Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B|The percentage of participants with >15% drop in weight percentile for age from Baseline to each visit was reported.|Weeks 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."|||percentage of participants|||Number
2666885|NCT01519960|Secondary|Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B|The percentage of participants with >15% drop in height percentile for age from Baseline to each visit was reported.|Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)|"Safety Population. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."|||percentage of participants|||Number
2666886|NCT01519960|Secondary|Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category|AUC was estimated using population pharmacokinetic (PK) modeling. The AUC at steady-state was averaged among participants who received PEG-IFN and reported by BSA category. Categories of BSA-based dosing used in the analysis were as follows: 0.54-0.74 m^2, 65 mcg; 0.75-1.08 m^2, 90 mcg; 1.09-1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg. The estimated AUC was expressed in hours by nanograms per milliliter (h*ng/mL).|Pre-dose (0 hours) at Baseline and Weeks 4, 8, 12, 24; post-dose (24-48, 72-96, 168 hours) during Weeks 1, 24 (up to 24 weeks overall)|"PK Substudy Population: All participants who consented to participate in the PK substudy. The Number of Participants Analyzed reflects the total combined number of participants who provided evaluable data across all BSA categories. The number of participants who provided evaluable data within each BSA category (n) is shown in the table."|||h*ng/mL||Full Range|Mean
2666887|NCT01519960|Secondary|Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C|Liver elastography was performed to assess elasticity and extent of hepatic fibrosis. The change in LSM from Baseline to each visit was averaged among all participants in expressed in kilopascals (kPa). Positive changes in LSM values corresponded to an increase in stiffness and hepatic fibrosis.|Baseline; Week 48; FU Week 24 (up to 72 weeks overall)|"Liver Substudy Population: All participants who consented to participate in the liver elasticity substudy. The Number of Participants Analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table."|||kPa||Standard Deviation|Mean
2666888|NCT01519960|Secondary|Change From Baseline in Quantitative HBV DNA Level in Group C|The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.|Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||log10 IU/mL||Standard Deviation|Mean
2673494|NCT01461655|Secondary|Non-inflammatory Lesions Count|Percentage change in non-inflammatory lesions count from baseline to the end of treatment|Baseline to End of treatment (4 weeks)||||percentage of change||Standard Deviation|Mean
2666889|NCT01519960|Secondary|Quantitative HBV DNA Level in Group C|Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||log10 IU/mL||Standard Deviation|Mean
2666890|NCT01519960|Secondary|Quantitative Serum ALT Level in Group C|Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).|Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||factor of ULN||Standard Deviation|Mean
2666891|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2666892|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2666893|NCT01519960|Secondary|Percentage of Participants With HBV DNA Undetectable at EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2666894|NCT01519960|Secondary|Percentage of Participants With HBV DNA <2,000 IU/mL at EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2666895|NCT01519960|Secondary|Percentage of Participants With HBV DNA <20,000 IU/mL at EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2666896|NCT01519960|Secondary|Percentage of Participants With Normal ALT at EOT in Group C|Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2666897|NCT01519960|Secondary|Percentage of Participants With Loss of HBsAg at EOT in Group C|The percentage of participants with loss of HBsAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2666898|NCT01519960|Secondary|Percentage of Participants With HBsAg Seroconversion at EOT in Group C|HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2666899|NCT01519960|Secondary|Percentage of Participants With Loss of HBeAg at EOT in Group C|The percentage of participants with loss of HBeAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2666900|NCT01519960|Secondary|Percentage of Participants With HBeAg Seroconversion at EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2666901|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2666902|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2666903|NCT01519960|Secondary|Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2666904|NCT01519960|Secondary|Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2666922|NCT01519960|Secondary|Percentage of Participants With HBeAg Seroconversion at EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2666905|NCT01519960|Secondary|Percentage of Participants With HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2666906|NCT01519960|Secondary|Percentage of Participants With Normal ALT at 24 Weeks After EOT in Group C|Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2666907|NCT01519960|Secondary|Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT in Group C|The percentage of participants with loss of HBsAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2666908|NCT01519960|Secondary|Percentage of Participants With HBsAg Seroconversion at 24 Weeks After EOT in Group C|HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population.|||percentage of participants||95% Confidence Interval|Number
2666909|NCT01519960|Secondary|Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT in Group C|The percentage of participants with loss of HBeAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Safety Population: All participants who received at least one dose of study drug (if assigned) and had at least one post-baseline safety assessment.|||percentage of participants||95% Confidence Interval|Number
2666910|NCT01519960|Secondary|Change From Baseline in Quantitative HBV DNA Level in Groups A and B|The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL.|Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||log10 IU/mL||Standard Deviation|Mean
2666911|NCT01519960|Secondary|Quantitative HBV DNA Level in Groups A and B|Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL.|Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||log10 IU/mL||Standard Deviation|Mean
2666912|NCT01519960|Secondary|Quantitative Serum ALT Level in Groups A and B|Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN).|Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)|ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.|||factor of ULN||Standard Deviation|Mean
2666913|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2666914|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2666915|NCT01519960|Secondary|Percentage of Participants With HBV DNA Undetectable at EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2666916|NCT01519960|Secondary|Percentage of Participants With HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2666917|NCT01519960|Secondary|Percentage of Participants With HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2666918|NCT01519960|Secondary|Percentage of Participants With Normal ALT at EOT/POP in Groups A and B|Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2666919|NCT01519960|Secondary|Percentage of Participants With Loss of HBsAg at EOT/POP in Groups A and B|The percentage of participants with loss of HBsAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2666920|NCT01519960|Secondary|Percentage of Participants With HBsAg Seroconversion at EOT/POP in Groups A and B|HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2666921|NCT01519960|Secondary|Percentage of Participants With Loss of HBeAg at EOT/POP in Groups A and B|The percentage of participants with loss of HBeAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|Week 48|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2666923|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2666924|NCT01519960|Secondary|Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2666925|NCT01519960|Secondary|Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA <29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2666926|NCT01519960|Secondary|Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B|HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA <2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2666927|NCT01519960|Secondary|Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After EOT/POP in Groups A and B|HBV DNA was quantified using polymerase chain reaction (PCR) by Roche Taqman. The percentage of participants with HBV DNA <20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2666928|NCT01519960|Secondary|Percentage of Participants With Normal ALT at 24 Weeks After EOT/POP in Groups A and B|Normal ALT was defined as ALT less than or equal to (≤) ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2666929|NCT01519960|Secondary|Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT/POP in Groups A and B|The percentage of participants with loss of HBsAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2666930|NCT01519960|Secondary|Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at 24 Weeks After EOT/POP in Groups A and B|HBsAg seroconversion was defined as loss of HBsAg and the presence of hepatitis B surface antibody (anti-HBs). The percentage of participants with HBsAg seroconversion at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2666931|NCT01519960|Secondary|Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT/POP in Groups A and B|The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2666932|NCT01519960|Primary|Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B|HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method.|FU Week 24 (up to 72 weeks overall)|Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.|||percentage of participants||95% Confidence Interval|Number
2666933|NCT01519947|Secondary|Incidence of Red Blood Cell Transfusions|This outcome measure was not assessed.|Up to approximately 20 months|Data were not collected.||||||
2666934|NCT01519947|Secondary|Percentage of Participants Requiring Dose Adjustments|This outcome measure was not assessed.|Up to approximately 20 months|Data were not collected.||||||
2666935|NCT01519947|Secondary|Percentage of Participants With Adverse Events|An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.|Up to approximately 20 months|The safety population included all enrolled participants who received at least one dose of study drug and had a subsequent safety evaluation dose.|||percentage of participants|||Number
2666936|NCT01519947|Secondary|Percentage of Participants Achieving Target Hemoglobin Concentration 11-12 g/dL After 3 and 6 Months of Treatment||3 and 6 months|The intent-to treat (ITT) population included all enrolled participants who received at least one dose of study drug and had baseline and post-baseline measurements of the primary outcome measure.|||percentage of participants|||Number
2666937|NCT01519947|Secondary|Change in Hemoglobin Concentration||From baseline to 6 months|The intent-to treat (ITT) population included all enrolled participants who received at least one dose of study drug and had baseline and post-baseline measurements of the primary outcome measure. Data are reported for evaluable participants.|||grams per deciliter (g/dL)||Standard Deviation|Mean
2666938|NCT01519947|Primary|Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL||Up to approximately 20 months|The intent-to treat (ITT) population included all enrolled participants who received at least one dose of study drug and had baseline and post-baseline measurements of the primary outcome measure.|||micrograms (mcg)||Standard Deviation|Mean
2666939|NCT01519934|Secondary|Patient Satisfaction|Percentage of subjects reporting satisfaction as measured using a Patient Satisfaction Questionnaire.|180 days post-treatment||||percentage of participants|||Number
2666941|NCT01519934|Secondary|Overall Aesthetic Improvement|"Overall aesthetic improvement was assessed based on a Global Aesthetic Improvement Scale (GAIS) scores; PGAIS completed by a clinician assessor, SGAIS completed by the study subject. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse"|Baseline to 180 days post-treatment||||percentage of participants|||Number
2666942|NCT01519934|Primary|Improvement in Overall Lifting and Tightening of the Skin|Determined by a masked, qualitative assessment of photographs at 180 days post treatment compared to pre-treatment baseline photographs. A panel of three blinded assessors reviewed pre-treatment and post-treatment photos. Each blinded assessor was provided an identical set of pre-treatment and Day 180 post-treatment photos to assess. The pre/post treatment photos were consistent in lighting, subject positioning and focus. The visit interval of each photo, i.e. pre and post treatment, was NOT marked. Each blinded assessor conducted their assessment independently with no input from another blinded assessor, comparing each set of photos. Each assessor indicated those subjects assessed as improved.|Baseline to 180 days post-treatment||||percentage of participants|||Number
2666943|NCT01519921|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Events (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Participants with any AEs and any SAEs have been presented.|Up to Week 72|Safety population included participants who received at least one dose of study medication and who had at least one post-baseline safety assessment.|||Participants|||Number
2666944|NCT01519921|Secondary|Percentage of Participants With Hepatitis B Surface Antigen Seroconversion At Week 48 and Week 72|A responder was a participant with loss of HBsAg and presence of anti-HBs at EOT and EOF period.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2666945|NCT01519921|Secondary|Percentage of Participants With Loss of Hepatitis B Surface Antigen At Week 48 and Week 72|A responder was a participant who were analysed with loss of Hepatitis B Surface Antigen (HBsAg) at EOT and EOF period.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2666946|NCT01519921|Secondary|Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion|A responder was a participant with loss of HBeAg and presence of anti-HBe at EOT and EOF period.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2666947|NCT01519921|Secondary|Percentage of Participants With a Combined Response At Week 48 and Week 72|A responder with Combined Response was a participant with HBV-DNA<100,000 copies/mL, HBeAg seroconversion (i.e. loss of HBeAg and presence of anti-HBe) and ALT normalization at EOT and EOF period.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2666948|NCT01519921|Secondary|Percentage of Participants With Hepatitis B Virus DNA Below the Limit of Detection At Week 48 and Week 72|Participants with HBV-DNA below the limit of detection i.e. <174 copies/mL at EOT and EOF period were responders.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2666949|NCT01519921|Secondary|Percentage of Participants With ALT Normalization At Week 48 and Week 72|Participants with ALT less than the upper limit of normal (ULN) at end of treatment (EOT) and EOF period were responders.|Week 48 and Week 72|The ITT population included all participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2666950|NCT01519921|Primary|Percentage of Participants With Hepatitis B Virus e Antigen Loss At Week 72|Participants with loss of hepatitis B virus e antigen (HBeAg) at the EOF period (24 weeks after the end of treatment) were classified as responders.|Week 72|The ITT population included all participants who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2666951|NCT01519921|Primary|Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72|Participants who had Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) levels below 100,000 copies per milliliter (mL) at the end of follow-up (EOF) period (24 weeks after the end of treatment) were classified as responders.|Week 72|Intent-to-treat (ITT) population included all participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2666952|NCT01519882|Secondary|Change From Baseline in the Total Number of Turnings in Bed to Week 4 of the Maintenance Period|"Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.~Readings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.~The subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.~The number of turnings in bed was determined via a postural sensor placed on the subject's chest."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)||||Number of turnings in bed|||Number
2666953|NCT01519882|Secondary|Change From Baseline in the Total Wake Time After Sleep Onset (WASO) to Week 4 of the Maintenance Period|"Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.~Readings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.~The subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.~Sleep stages and time spent in each sleep stage were determined from EEG readings. WASO was calculated by:~(Time in bed (Period between lights off and lights on))-(Sleep time)."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)||||minutes||Standard Deviation|Mean
2668949|NCT01499810|Secondary|Change in Daytime Systolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring (ABPM)|from baseline to 12 months||||mmHg||Standard Error|Mean
2666954|NCT01519882|Secondary|Change From Baseline in the Nocturnal Akinesia, Dystonia and Cramps Score (NADCS) to Week 4 of the Maintenance Period|The NADCS assesses nocturnal akinesia, dystonia, and cramps using an ordinal severity scale. While a score of 0 = normal and 4 = maximal severity, subjects can also rate their symptoms with values of 0.5, 1.5, 2.5, and 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps score was used to evaluate pain. A negative value in Change from Baseline indicates an improvement.|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)||||units on a scale||Standard Deviation|Mean
2666955|NCT01519882|Secondary|Change From Baseline in the Nocturnal Akinesia, Dystonia, and Cramps Score (NADCS) to Day 1 of the Maintenance Period|The NADCS assesses nocturnal akinesia, dystonia, and cramps using an ordinal severity scale. While a score of 0 = normal and 4 = maximal severity, subjects can also rate their symptoms with values of 0.5, 1.5, 2.5, and 3.5. The nocturnal akinesia score was used to evaluate motor performance while the dystonia and cramps score was used to evaluate pain. A negative value in Change from Baseline indicates an improvement.|From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)||||units on a scale||Standard Deviation|Mean
2666956|NCT01519882|Secondary|Change From Baseline in the Sleep Period Time in Non-Rapid Eye Movement (Non-REM) Sleep to Week 4 of the Maintenance Period|"Polysomnography (PSG) was performed for the 2 consecutive nights prior to Day 1 and the 2 consecutive nights prior Week 4 of the Maintenance Period.~Readings from the first night of the PSG will not be used for analysis as this is considered an adaptation night.~The subject was not allowed to sleep during the daytime on the day of a PSG reading. The PSG was recorded for a minimum of 6 h and a maximum of 8 h.~The sleep period time in stage 3 non-REM was derived from the hypnogram, based on Electroencephalogram (EEG), Electro-myogram (EMG), Electro-oculogram (EOG) and Electrocardiogram (ECG). Change from Baseline is calculated by:~(Stage 3 non-REM time (in minutes) at Baseline)- (Stage 3 non-REM time (in minutes) at Week 4 of the MP)."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)||||minutes||Standard Deviation|Mean
2666957|NCT01519882|Secondary|Change From Baseline in the Epworth Sleepiness Score (ESS) to Week 4 of the Maintenance Period|"The ESS measures the subject's general level of daytime sleepiness. The 8 items of this scale assess the probability of falling asleep in a variety of situations. Each item is scored by the subject using the following categories:~0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 4 = high chance of dozing.~The ESS score ranges from 0 to 32, with higher values indicating a higher level of daytime sleepiness. A negative value in Change from Baseline indicates a decrease in daytime sleepiness."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)||||units on a scale||Standard Deviation|Mean
2666958|NCT01519882|Secondary|Change From Baseline in the Epworth Sleepiness Score (ESS) to Day 1 of the Maintenance Period|"The ESS measures the subject's general level of daytime sleepiness. The 8 items of this scale assess the probability of falling asleep in a variety of situations. Each item is scored by the subject using the following categories:~0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 4 = high chance of dozing.~The ESS score ranges from 0 to 32, with higher values indicating a higher level of daytime sleepiness. A negative value in Change from Baseline indicates a decrease in daytime sleepiness."|From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)||||units on a scale||Standard Deviation|Mean
2666959|NCT01519882|Secondary|Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Week 4 of the Maintenance Period|"The PDSS2 is a scale to assess sleep and nocturnal disability in Parkinson's Disease during the previous 7 days, and is designed for self-completion by the subject. The updated version (PDSS2) contains 15 questions to be answered using a 5-point Likert scale, where 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = very often.~Thus, PDSS2 score ranges from 0-60, with higher scores indicating worse sleep and higher nocturnal disability. A negative value in Change from Baseline indicates improved sleep and less nocturnal disability."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)||||units on a scale||Standard Deviation|Mean
2666960|NCT01519882|Secondary|Change From Baseline in the Parkinson's Disease Sleep Scale Score Version 2 (PDSS2) to Day 1 of the Maintenance Period|"The PDSS is a scale to assess sleep and nocturnal disability in Parkinson's Disease during the previous 7 days, and is designed for self-completion by the subject. The updated version (PDSS2) contains 15 questions to be answered using a 5-point Likert scale, where 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, and 4 = very often.~Thus, PDSS2 score ranges from 0-60, with higher scores indicating worse sleep and higher nocturnal disability. A negative value in Change from Baseline indicates improved sleep and less nocturnal disability."|From Baseline to Day 1 of the Maintenance Period (up to 7 weeks post-baseline)||||units on a scale||Standard Deviation|Mean
2666961|NCT01519882|Primary|Percentage Change From Baseline in Sleep Efficiency Index (SEI) to Week 4 of the Maintenance Period|"The Sleep Efficiency Index in percent is the ratio of total sleep time (based on Polysomnography recordings) to time in bed (period between lights off and lights on)."|From Baseline to Week 4 of the Maintenance Period (up to 11 weeks post-baseline)||||percentage change||Standard Deviation|Mean
2666962|NCT01519817|Secondary|Changes in Soluble Cluster of Differentiation 40L (sCD40L)|Blood samples were collected and changes in serum levels of soluble sCD27 were assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD40L was determined by p value (Wilcoxon test) and the median and interquartile range of data.|Pre (Baseline) and Day 85 after 6 vaccinations|Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.|||ng/ml||Inter-Quartile Range|Median
2666963|NCT01519817|Secondary|Median Ratio of Soluble Cluster of Differentiation 27:40L (sCD27:sCD40L)|Blood samples were collected and changes in serum levels of the ratio of soluble sCD27:sCD40L was assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD27:sCD40L was determined by p value (Wilcoxon test) and the median and interquartile range of data.|Pre (Baseline) and Day 85 after 6 vaccinations|Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.|||Ratio||Inter-Quartile Range|Median
2667294|NCT01516749|Secondary|Change in Dermatology Quality of Life Index (DLQI)|Patient self-administered questionnaire measuring the extent to which disease affects quality of life, range 0-30, with higher score reflecting a larger negative effect of disease on quality of life|Baseline, 8 weeks|Patients who completed 8 weeks of therapy|||units on a scale||95% Confidence Interval|Mean
2666964|NCT01519817|Secondary|Changes in Soluble Cluster of Differentiation 27 (sCD27)|Blood samples were collected and changes in serum levels of soluble sCD27 were assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD27 was determined by p value (Wilcoxon test) and the median and interquartile range of data.|Pre (Baseline) and Day 85 after 6 vaccinations|Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.|||U/ml||Inter-Quartile Range|Median
2666965|NCT01519817|Secondary|Changes in Serum Levels of Cytokines|Blood samples were collected and changes in serum levels of cytokines interferon gamma (IFNg), Interleukin 10 (IL-10), Interleukin 12 (IL-12)p70, Interleukin 1b (IL-1b), Interleukin 2 (IL-2), Interleukin 6 (IL-6), Interleukin 8 (IL-8), and tumor necrosis factor (TNF) were assessed by the multiplexed mesoscale assay. Significance of changes in serum levels of cytokines was determined by p value (Wilcoxon test) and the median and interquartile range of data.|Pre (Baseline) and Day 85 after 6 vaccinations|Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.|||pg/ml||Inter-Quartile Range|Median
2666966|NCT01519817|Secondary|Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)|Blood samples will be collected via apheresis and analyzed by multicolor flow cytometry in PBMCs for cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), Natural Killer (NK), Natural Killer T (NKT), conventional dendritic cell (cDC), plasmacytoid dendritic cell (pDC), myeloid-derived suppressor cell (MDSC), Tregs, CD4 central memory (CD4 CM), CD4 effector memory (CD4 EM), CD4 terminal effector memory (CD4 EMRA), CD4 naïve, CD8 CM, CD8 EM, CD8 EMRA, and CD8 naïve cells. Significance of changes in immune cells was determined by p value (Wilcoxon test) and the median and interquartile range of data.|Pre (Baseline) and Day 85 after 6 vaccinations|Due to insufficient samples at some time points in some patients, all participants were not analyzed in dose levels 2, 3 and 4; thus a statistical analysis was not performed.|||percentage of PBMC||Inter-Quartile Range|Median
2666967|NCT01519817|Secondary|Number of Participants With a Clinical Benefit Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)|Clinical benefit is defined as partial response (PR) or stable disease (SD) and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Partial response is ≥30% decrease in the sum of greatest diameters/no new lesions. Progressive disease is ≥20% increase in the sum of greatest diameters/new lesions. Stable disease does not meet criteria for complete response (disappearance of all lesions; no new lesions), partial response, or progressive disease.|3 and 5 months restaging|One participant was not evaluable and came off study due to infection prior to restaging. Two participants were not evaluable due to withdrawal from the study or lack of measurable disease. Three patients with stable disease at 3 months elected to pursue alternate treatment and did not have 5 month restaging.|||Participants|||Count of Participants
2666968|NCT01519817|Primary|Count of Participants With Adverse Events of Escalating Doses of Yeast Brachyury ( GI- 6301) Vaccine|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. A non-serious adverse event is any untoward medical occurrence.|4 years and 25 days||||Participants|||Count of Participants
2666969|NCT01519817|Primary|Number of Participants With Brachyury-Specific T-cell Responses|A fluorescense activated cell sorting (FACS)-based assay for cluster of differentiation 4 (CD4) or cluster of differentiation 8 (CD8) T-cells expressing the cytokines interferon (IFN) gamma, interleukin 2 (IL2), and tumor necrosis factor (TNF) alpha, and/or cluster of differentiation 107a (CD107a) (a marker for lytic potential) was used to determine the numbers of participants showing development or enhancement of the level of brachyury-specific T-cells after vaccination.|Baseline (pre-vaccination) and approximately day 84 (after 6 vaccinations)|Sufficient peripheral blood mononuclear cells (PBMCs) were available before and after vaccination from 31 of 34 patients to analyze brachyury-specific CD4 and CD8 T-cell responses.|||Participants|||Count of Participants
2666970|NCT01519791|Secondary|Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 52|LDA is defined as achieving a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2.|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
2666971|NCT01519791|Secondary|Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|The Arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.|||units on a scale||Standard Deviation|Mean
2666972|NCT01519791|Secondary|Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days missed of family/social/leisure activities in the last month.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.|||days||Standard Deviation|Mean
2666973|NCT01519791|Secondary|Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with hired outside help in the last month.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.|||days||Standard Deviation|Mean
2666974|NCT01519791|Secondary|Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with reduced household work productivity in the last month.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.|||days||Standard Deviation|Mean
2666975|NCT01519791|Secondary|Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of days with no household work in the last month.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.|||days||Standard Deviation|Mean
2666976|NCT01519791|Secondary|Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|The Arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) for employed subjects.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.|||units on a scale||Standard Deviation|Mean
2666977|NCT01519791|Secondary|Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of work days with reduced productivity in the last month for employed subjects.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.|||days||Standard Deviation|Mean
2666978|NCT01519791|Secondary|Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 52|Number of work days missed in the last month for employed subjects.|Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing WPS-RA values were imputed using LOCF.|||days||Standard Deviation|Mean
2666979|NCT01519791|Secondary|Change From Baseline in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 52|"BRAF-MDQ total score ranges from 0 to 70 (with higher scores indicating worse fatigue).~A negative value in BRAF-MDQ change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing BRAF-MDQ values were imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
2666980|NCT01519791|Secondary|Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) to Week 52|"The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.~The total score ranges from 0 (no difficulty) to 3 (unable to do) with lower scores meaning lower disability.~A negative value in HAQ-DI change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing HAQ-DI values were imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
2666981|NCT01519791|Secondary|Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 52|"Normative physical function is defined as HAQ-DI score ≤ 0.5. The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.~The total score ranges from 0 to 3 with lower scores meaning lower disability."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
2666982|NCT01519791|Secondary|Change From Baseline in Simplified Disease Activity Index (SDAI) to Week 52|"SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.~The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing SDAI values were imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
2666983|NCT01519791|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) to Week 52|"CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.~The CDAI score ranges from 0 to 76, with a negative value in CDAI change from Baseline indicating an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing CDAI values were imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
2667084|NCT01519414|Secondary|Proportion of Patients Who Respond|An assumed binomial distribution used. Summarized with their corresponding 95% binomial confidence intervals and compared in an exploratory manner between the two treatment arms. Dichotomized outcomes of response will be descriptively summarized and graphically evaluated using bar graphs.|At 12 weeks||||percentage of patients||95% Confidence Interval|Number
2666984|NCT01519791|Secondary|Change From Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 52|"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:~0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Last Observation Carried Forward (LOCF). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR). Missing DAS28(ESR) values were imputed using LOCF.|||units on a scale||Standard Error|Least Squares Mean
2666985|NCT01519791|Secondary|Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 52|"Good response is defined as:~DAS28[ESR] ≤ 3.2 and decrease from Baseline by > 1.2;~moderate response is defined as achievement of one of the following:~DAS28[ESR] ≤ 3.2 and decrease from Baseline > 0.6 and ≤ 1.2~DAS28[ESR] > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6~DAS28[ESR] > 5.1 and decrease from Baseline >1.2."|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1). The FAS1 consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement within Period 1 for the primary efficacy assessment of DAS28(ESR).|||percentage of subjects|||Number
2666986|NCT01519791|Secondary|Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice at Week 52|"The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as:~Tender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1 and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
2666987|NCT01519791|Secondary|Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) < 2.6 at Week 52|"DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:~0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
2666988|NCT01519791|Secondary|Percentage of Subjects With Simplified Disease Activity Index (SDAI) ≤ 3.3 at Week 52|SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
2666989|NCT01519791|Secondary|Percentage of Subjects With Clinical Disease Activity Index (CDAI) ≤ 2.8 at Week 52|CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
2666990|NCT01519791|Secondary|Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 52|"The ACR/EULAR 2011 remission criteria is defined as:~Tender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1, C-reactive protein (CRP) ≤ 1 mg/dl and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
2666991|NCT01519791|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52|The assessments are based on a 70 % or greater improvement from Baseline in the number of tender joints, a 70 %, or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
2667085|NCT01519414|Secondary|Changes in PSA Levels|Evaluated and patterns graphically explored through waterfall plots.|Baseline to 12 weeks||||percentage change from baseline||Full Range|Median
2667112|NCT01519167|Secondary|Frequency of Midazolam Required for Sedation|Frequency of rescue sedation (midazolam) required to maintain a subject within the target sedation range (UMSS score greater than 1 or N-PASS score less than -2).|During the treatment period, up to approximately 24 hours|Number of subjects who received any amount (mg) of rescue midazolam for sedation in efficacy evaluable population.|||Occurrence||Full Range|Median
2666992|NCT01519791|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52|The assessments are based on a 50 % or greater improvement from Baseline in the number of tender joints, a 50 %, or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
2666993|NCT01519791|Secondary|Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52|The assessments are based on a 20 % or greater improvement from Baseline in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).|From Baseline (Week 0) to Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
2666994|NCT01519791|Secondary|Change From Baseline in the Joint Narrowing Score to Week 52|Joint space narrowing (JSN) was assessed in 15 locations per hand and 6 locations per foot. Joint space narrowing for each location was scored from 0 to 4, with 0 indicating no narrowing. The maximum possible score for JSN in all 30 hand joints was 120. The maximum possible score for JSN in all 12 feet joints was 48. Thus, the maximum possible total JSN score for Hands and feet was 168.|From Baseline (Week 0) to Week 52|The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.|||units on a scale||Standard Deviation|Mean
2666995|NCT01519791|Secondary|Change From Baseline in the Joint Erosion Score to Week 52|"Erosions were assessed in 16 locations per hand and 6 joints per foot. Erosions for each hand location were scored from 0 to 5, with 0 indicating no erosion. Scores 1 to 5 may have included combinations of discrete erosion(s) and/or large erosions. Erosions for each foot joint were scored from 0 to 10, with 0 indicating no erosions.~The maximum possible erosion score for all 32-hand joints was 160. The maximum possible erosion score for all 12 feet joints was 120. Thus, the maximum possible total erosion score for hands and feet was 280."|From Baseline (Week 0) to Week 52|The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.|||units on a scale||Standard Deviation|Mean
2666996|NCT01519791|Secondary|Percentage of Subjects With Radiographic Non-progression From Baseline to Week 52|Radiographic non-progression is defined as change in mTSS ≤ 0.5.|From Baseline (Week 0) to Week 52|The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.|||percentage of subjects|||Number
2666997|NCT01519791|Secondary|Change From Baseline in Modified Total Sharp Score (mTSS) to Week 52|Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.|From Baseline (Week 0) to Week 52|The Radiographic Set Period 1 (RAD1) consisted of those subjects in the FAS1 who had provided valid radiographs (ie, radiographs resulting in a nonmissing mTSS score) at Baseline and at Week 52 or the Withdrawal Visit.|||units on a scale||Standard Deviation|Mean
2666998|NCT01519791|Secondary|Percentage of Subjects in Sustained Low Disease Activity (LDA) at Week 52|Sustained LDA is defined as a Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) ≤ 3.2 at both Weeks 40 and 52.|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
2666999|NCT01519791|Primary|Percentage of Subjects in Sustained Remission at Week 52|"Sustained remission is defined as a Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at both Weeks 40 and 52.~DAS28[ESR] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula:~0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x lognat (ESR) + 0.014 x PtGADA, where 28 joints are examined and a lower score indicates less disease activity."|Week 52|Full Analysis Set Period 1 (FAS1) with Non-Responder Imputation (NRI). FAS1 consisted of all subjects with valid Baseline and valid post-Baseline efficacy measurement within Period 1 for DAS28(ESR). For NRI, a subject having missing data for the time point assessed was conservatively counted as a nonremitter or nonresponder.|||percentage of subjects|||Number
2667000|NCT01519778|Primary|Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)|Safety will be assessed through summaries of the incidence of AEs and SAEs as well as through summaries of vital signs, physical examinations, ECG findings, and laboratory assessments (hematology, serum chemistry, and urinalysis).|24-31 days|Patients receiving any amount of study drug|||participants|||Number
2667001|NCT01519765|Secondary|Patient Preference|All patients were given a patient satisfaction survey after delivery. They were asked to select their preference for misoprostol intervention type: buccal, vaginal, or either.|Until 72 hours after delivery|All participants were given the survey however incomplete collection was obtained.|||participants|||Number
2667310|NCT01516632|Secondary|Continuous Abstinence at 4-weeks Post-quit|Smoking five or fewer cigarettes since quit day at 4 weeks post-quit as verified by a significant other|4 weeks post-quit||||participants|||Number
2667002|NCT01519765|Secondary|Patient Satisfaction With Buccal Versus Vaginal Misoprostol Administration.|"All patients were given a patient satisfaction survey. Patients were asked to use a Likert scale to rate their experience on the following:~Likert sub-scale: 1 to 5~1=Not at all/ Never to 5= Very Much/ Always~Nausea and vomiting 1=better outcome 5=worse outcome~effectiveness of misoprostol 1=worse outcome 5=better outcome~concerns of misoprostol 1=better outcome 5=worse outcome~overall labor experience 1=worse outcome 5=better outcome Patients will be followed for the duration of their labor(usually up to 72hrs). The satisfaction survey will be conducted after delivery but will evaluate side effects that they recollect in labor."|Until 72 hours after delivery|Patient surveys were requested from all participants however incomplete patient survey collection was obtained.|||units on a scale||Full Range|Median
2667003|NCT01519765|Secondary|APGARS|"Median (APGAR) score at 5 minutes after delivery. APGAR: Appearance, Pulse, Grimace, Activity, Respiration Apgar scale is determine by evaluating a newborn on 5 categories on a scale from 0 to 2, then summing up the five values.~Score range is 0 to 10. Score above 7 are generally normal. Score below 3 may indicated poor status."|5 minutes after delivery||||score||Full Range|Median
2667004|NCT01519765|Secondary|Chorioamnionitis|Percentage of participants affected with chorioamnionitis|Until 48 hours after delivery||||percentage of participants||95% Confidence Interval|Number
2667005|NCT01519765|Secondary|Meconium|Percentage of participants who developed meconium was computed. Presence of meconium was evaluated by the delivering physician. P-value was computed using Fisher exact test.|Until delivery||||percentage of participants||95% Confidence Interval|Number
2667006|NCT01519765|Secondary|Neonatal Intensive Care Unit (NICU) Admission|"Percentage of participants whose baby was admitted to NICU was computed from time to delivery to time of hospital discharge.~P-value was computed using Fisher Exact test."|Until discharge from hospital||||percentage of participants||95% Confidence Interval|Number
2667007|NCT01519765|Secondary|Tachysystole|Fetal heart tracing was reviewed until 4 hours after last misoprostol dose. Percentage of participant with tachysystole were computed. Tachysystole was defined as more than five uterine contractions in 10 minutes. P value was computed using Fisher exact test|Until 4 hours after last misoprostol dose||||percentage of participants||95% Confidence Interval|Number
2667008|NCT01519765|Secondary|Tachysystole With Abnormal FHT|"Feta heart tracing was reviewed for every participant until 4 hours from last misoprostol dose.~Percentage of participants who presented with tachysystole and abnormal fetal heart tracing was computed.~Abnormal fetal heart tracing was defined as category 2 and above. Tachysystole was defined as more than 5 uterine contractions within 10 minutes. P values were computed by Fisher exact test."|Until 4 hours after last misoprostol dose||||percentage of participants||95% Confidence Interval|Number
2667009|NCT01519765|Secondary|Abnormal Fetal Heart Tracing (FHT)|"Feta heart tracing was reviewed for every participant until 4 hours from last misoprostol dose.~Percentage of participants who presented with abnormal fetal heart tracing was computed.~Abnormal fetal heart tracing was defined as category 2 and 3 fetal heart tracing according to standard criteria.~Abnormal fetal heart tracing included any of the following tachycardia, bradycardia without absent variability, minimal variability, absent variability with or without recurrent decelerations, marked variability, prolonged deceleration and recurrent late deceleration, sinusoidal pattern.~P values were computed by Fisher exact test."|Until 4 hours of last misoprostol dose||||percentage of participants||95% Confidence Interval|Number
2667010|NCT01519765|Secondary|Artificial Rupture of Membranes (AROM)|Percentage of participants that required AROM|Until delivery||||percentage of participants||95% Confidence Interval|Number
2667011|NCT01519765|Secondary|Foley Bulb|Percentage of participants that required foley bulb use.|Until delivery||||percentage of participants||95% Confidence Interval|Number
2667012|NCT01519765|Secondary|Pitocin|Percentage of patients that used pitocin during labor. P-values were computed using Fisher exact test.|Until delivery||||percentage of participants||95% Confidence Interval|Number
2667013|NCT01519765|Secondary|Failed Induction of Labor|"Percentage of participants who were determined as a failed induction of labor. Failed induction was defined as no cervical change despite 24 hours of pitocin or 12 hours of pitocin after rupture of membranes.~P value was computed by Fisher exact test."|Until delivery||||percentage of participants||95% Confidence Interval|Number
2667014|NCT01519765|Secondary|Arrest of Dilation|"Percentage of participants who presented with arrest of dilation. Arrest of dilation was determined by the delivering physician.~P-value was computed using Fisher exact test."|Until delivery||||percentage of participants||95% Confidence Interval|Number
2667015|NCT01519765|Secondary|Number of Misoprostol Doses|Number of misoprostol 25 mcg doses used during induction of labor.|Until delivery||||doses||Full Range|Median
2667016|NCT01519765|Secondary|Cesarean Delivery Rate|Percentage of participants who underwent a cesarean delivery was computed. P-value was computed using Fisher's exact test.|Until delivery||||percentage of participants||95% Confidence Interval|Number
2667017|NCT01519765|Secondary|Rates of Vaginal Delivery|Percentage of participants who delivered vaginally|Until delivery||||percentage of participants||95% Confidence Interval|Number
2667018|NCT01519765|Secondary|Time to Active Labor|Time from induction to active labor. Active labor defined as 4 cm and above. P-value computed by Kruskal-Wallis test.|Until active labor||||hours||Full Range|Median
2667019|NCT01519765|Secondary|Time to Delivery|Time from induction to delivery. All participants were included.|Until delivery||||hours||Full Range|Median
2667020|NCT01519765|Secondary|Time to Vaginal Delivery|Time from start of induction to vaginal delivery was computed in participants who achieved vaginal delivery.|Start of induction until vaginal delivery|Participants who achieved vaginal delivery were included in the analysis|||hours||Full Range|Median
2667021|NCT01519765|Primary|Vaginal Delivery Within 24 Hours of Labor Induction|Percentage of participants able to achieve vaginal delivery within 24 hours of labor induction.|Within 24 hours of labor induction||||percentage of participants||95% Confidence Interval|Number
2667086|NCT01519414|Primary|Progression-free Survival (PFS) Based on the RECIST Criteria|The progression-free survival distributions between the two arms will be compared using log-rank tests. Progression-free survival curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model.|Time from study entry to the date of documented progression and/or death, assessed up to 6 months||||months||95% Confidence Interval|Median
2667022|NCT01519713|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine|"Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.~Grade 3 solicited reactions were defined as: Pain incapacitating (children) and prevents daily activities (adolescents and adults). Fever ≥ 39.0°C; Headache, Malaise and Myalgia, significant, prevents daily activities."|Day 0 up to Day 28 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, Intent-to-treat population.|||Participants|||Number
2667023|NCT01519713|Secondary|Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).|28 Days post-vaccination|Geometric mean titer ratios of antibodies against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.|||Titers||95% Confidence Interval|Geometric Mean
2667024|NCT01519713|Secondary|Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).|Days 0 and 28 post-vaccination|Geometric mean titers of antibodies against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
2667025|NCT01519713|Secondary|Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine.|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).|28 Days post-vaccination|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.|||Participants|||Number
2667026|NCT01519713|Secondary|Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).|28 Days post-vaccination|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.|||Participants|||Number
2667027|NCT01519713|Primary|Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR). Sero protection was defined as SBA-BR titer of ≥ 1:128.|28 Days post-vaccination|Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined in all enrolled and vaccinated participants, per-protocol population.|||Participants|||Number
2667028|NCT01519700|Secondary|Incidence of Hospitalizations Due to Febrile Neutropenia|Incidence of hospitalizations due to Febrile Neutropenia|21 Weeks/ 6 cycles|SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1.|||participants|||Number
2667029|NCT01519700|Secondary|Frequency of Infections|Frequency of infections by cycle and across all cycles|21 Weeks/ 6 cycles|SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1. Comparison made for alternating versus non-alternating treatment groups.|||participants|||Number
2667030|NCT01519700|Secondary|Time to Absolute Neutrophil Count Recovery|Time to Absolute Neutrophil Count recovery, defined as the time in days from Absolute Neutrophil Count nadir until the patient's Absolute Neutrophil Count increases to more or equal to 2*10^9 cells/L after the nadir in cycle 1|Cycle 1/ 21 days|FAS (full analysis) set: all patients who received at least one dose of study medication, analyzed according to randomization allocation. In the EP2006 + EP2006 & Neupogen group, one patient’s time to Absolute Neutrophil Count recovery could not be measured as the nadir was the last measured timepoint.|||Days||Full Range|Median
2667031|NCT01519700|Secondary|Depth of Absolute Neutrophil Count Nadir|Depth of Absolute Neutrophil Count Nadir, defined as the patient's lowest Absolute Neutrophil Count in cycle 1|Cycle 1/ 21 days|FAS (full analysis) set: all patients who received at least one dose of study medication, analyzed according to randomization allocation|||10^9 cells/L||Standard Deviation|Mean
2667032|NCT01519700|Secondary|Number of Days of Fever|Number of days of fever by cycle. Fever is defined as oral temperature greater than or equal to 38.3°C.|21 weeks/ 6 cycles|PP-I (alternating Per-Protocol) set: randomized patients who completed all six chemotherapy cycles without major protocol violations.|||participants|||Number
2667033|NCT01519700|Secondary|Incidence of Febrile Neutropenia|Incidence of febrile neutropenia by duraton within each cycle and across all cycles. Febrile neutropenia is defined as oral temperature greater than or equal 38.3°C while having an Absolute Neutrophil Count < 0.5*10^9 cells/L (both measured on the same day)|21 weeks/ 6 cycles|SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1.|||participants|||Number
2667034|NCT01519700|Primary|Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy|Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5*10^9 cells/L)|21 days (Cycle 1 of chemotherapy treatment)|PP population|||Days||Standard Deviation|Mean
2667035|NCT01519674|Secondary|Change From Baseline in Patient Reported Outcome by Use of the Treatment Related Impact Measure - Diabetes.|Estimated mean change from baseline in Treatment Related Impact Measure - Diabetes (TRIM-D) 'total score' to end of trial. The score measured treatment satisfaction. The scores were transformed to a 0−100 scale with higher scores indicating greater satisfaction.|Week 0 to Week 24|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 545 subjects contributed to the statistical analysis at Week 24.|||scores||Standard Error|Least Squares Mean
2667311|NCT01516632|Secondary|Point Prevalence|A cigarette, even just a puff, within the last 7 days (yes/no).|4-weeks post-quit||||participants|||Number
2667036|NCT01519674|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes (Nocturnal and Day-time) Classified Both According to the American Diabetes Association (ADA) Definition and to an Additional Definition for Minor Episodes.|Number of treatment emergent hypoglycaemic episodes. Treatment emergent hypoglycaemic episode: if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Nocturnal: Time of onset between 00:01 and 05:59 a.m. (both included). Additional minor hypoglycaemic episode: symptomatic or asymptomatic hypoglycaemia with blood glucose (BG) values < 2.8 mmol/L (50 mg/dL) or plasma glucose (PG) < 3.1 mmol/L (56 mg/dL), and which was handled by the subject him/herself.|Week 0 to Week 24|Safety analysis set included all subjects receiving at least one dose of the investigational product.|||episodes|||Number
2667037|NCT01519674|Secondary|Adverse Events (AEs)|Rate of AEs per 100 years of patient exposure. An adverse event was defined as treatment emergent if the event had onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.|Week 0 to Week 24|Safety analysis set included all subjects receiving at least one dose of the investigational product.|||Events/100 years of patient exposure|||Number
2667038|NCT01519674|Secondary|Prandial Plasma Glucose (PPG) Overall Mean Increment.|Estimated overall mean post prandial increment after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 557 subjects contributed to the statistical analysis at Week 24.|||mmol/L||Standard Error|Least Squares Mean
2667039|NCT01519674|Secondary|Prandial Plasma Glucose (PPG) Increments at Dinner.|Estimated mean post prandial increments at dinner after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 550 subjects contributed to the statistical analysis at Week 24.|||mmol/L||Standard Error|Least Squares Mean
2667040|NCT01519674|Secondary|Prandial Plasma Glucose (PPG) Increments at Lunch.|Estimated mean post prandial increments at lunch after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 548 subjects contributed to the statistical analysis at Week 24.|||mmol/L||Standard Error|Least Squares Mean
2667041|NCT01519674|Secondary|Prandial Plasma Glucose (PPG) Increments at Breakfast|Estimated mean post prandial increments at breakfast after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 555 subjects contributed to the statistical analysis at Week 24.|||mmol/L||Standard Error|Least Squares Mean
2667042|NCT01519674|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Estimated mean change from baseline in fasting plasma glucose (FPG)|Week 0 to Week 24|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 556 subjects contributed to the statistical analysis at Week 24.|||mmol/L||Standard Error|Least Squares Mean
2667043|NCT01519674|Secondary|Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c ≤ 6.5%)|Proportion of subjects achieving HbA1c equal to or below 6.5% after 24 weeks of treatment.|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 559 subjects contributed to the statistical analysis at Week 24.|||percentage (%) of subjects|||Number
2667044|NCT01519674|Secondary|Responder for HbA1c, Proportion of Subjects Achieving Pre-defined HbA1c Targets (HbA1c < 7.0%)|Proportion of subjects achieving HbA1c below 7.0% after 24 weeks of treatment|After 24 weeks of treatment|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 559 subjects contributed to the statistical analysis at Week 24.|||percentage (%) of subjects|||Number
2667045|NCT01519674|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Estimated mean change from baseline in HbA1c after 24 weeks of treatment.|Week 0 to Week 24|Full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 559 subjects contributed to the statistical analysis at Week 24.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
2667046|NCT01519661|Secondary|Time to Use of New Anti-pseudomonal Antibiotic|Time to first use of new anti-pseudomonal antibiotic was analyzed.|Day 337|Safety set The safety set included all participants who received at least one dose of study drug.|||Days||95% Confidence Interval|Median
2667047|NCT01519661|Secondary|Number of Days of New Anti-pseudomonal Antibiotic Use|The total number of days of new anti-pseudomonal antibiotic use was analyzed.|Day 337|Safety set: The safety set included all participants who received at least one dose of study drug.|||Days||Standard Deviation|Mean
2667048|NCT01519661|Secondary|Percentage of Participants Who Used New Anti-pseudomonal Antibiotics||Day 337|Safety set: The safety set included all participants who received at least one dose of study drug.|||Percentage of participants|||Number
2667049|NCT01519661|Secondary|Time to First Hospitalization Due to Serious Respiratory-related Adverse Events|The day of first hospitalization due to serious respiratory-related adverse events was analyzed.|Day 337|Safety set The safety set included all participants who received at least one dose of study drug.|||Days||95% Confidence Interval|Median
2667050|NCT01519661|Secondary|Number of Hospitalization Days Due to Serious Respiratory-related Adverse Events|The total number of hospitalization days due to serious respiratory-related adverse events was analyzed.|Day 337|Safety set: The safety set included all participants who received at least one dose of study drug.|||Days||Standard Deviation|Mean
2667051|NCT01519661|Secondary|Percentage of Participants Hospitalized Due to Serious Respiratory-related Adverse Events||Day 337|Safety set: The safety set included all participants who received at least one dose of study drug.|||Percentage of participants|||Number
2667052|NCT01519661|Secondary|Tobramycin MIC 50 and MIC 90 Values Over All Isolates for the Sum of All Biotypes (Mucoid, Dry and Small Colony Variant) of Pseudomonas Aeruginosa|Tobramycin MIC 50 and MIC 90 values were defined as the lowest concentration of tobramycin required to inhibit 50% and 90%, respectively, of the P. aeruginosa strains tested.|Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337|Participants from the safety set who had data at each time point/cycle were analyzed at each time point. The safety set included all participants who received at least one dose of study drug.|||ug/mL|||Number
2667053|NCT01519661|Secondary|Change From Baseline in Pseudomonas Aeruginosa Colony Forming Units in Sputum|Sputum was collected in sterile containers and cultured for Pseudomonas aeruginosa (Pa.) (quantitative test) and other typical Cystic Fibrosis respiratory pathogens. The Pa. biotypes measured were mucoid, dry and small colony variant. Results are presented for the sum of all biotypes of Pa, with data transformed using a base 10 logarithm.|Baseline, day 1, day 29, day 85, day 141, day 197, day 253, day 309, day 337|Participants from the safety set who had Pa sputum density values at both baseline and the given time point were included in the analysis. The safety set included all participants who received at least one dose of study drug.|||log10 Colony Forming Unit (CFU)||Standard Deviation|Mean
2667054|NCT01519661|Secondary|Relative Change From Baseline in FEF Rate Over 25 to 75 Percent of Vital Capacity Predicted|Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recored at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FEEF25-75 from baseline to pre-dose day X = ((pre-dose day X FEF25-75 - baseline FEF25-75) / baseline FEF25-75) • 100.|Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.|Participants from the safety set who had values at both baseline and the given assessment day were included in the analysis for that assessment day. Therefore, the 'n' for each assessment day is different. The safety set included all participants who received at least one dose of study drug.|||Percent change||Standard Deviation|Mean
2667055|NCT01519661|Secondary|Relative Change From Baseline in FVC Percent Predicted|Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FVC % predicted from baseline to pre-dose day X = ((pre-dose day X FVC % predicted - baseline FVC % predicted) / baseline FVC % predicted) • 100.|Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.|Participants from the safety set who had values at both baseline and the given assessment day were included in the analysis for that assessment day. Therefore, the 'n' for each assessment day is different. The safety set included all participants who received at least one dose of study drug.|||Percent change||Standard Deviation|Mean
2667056|NCT01519661|Secondary|Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted|Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day X FEV1 % predicted - baseline FEV1 % predicted) / baseline FEV1 % predicted) • 100.|Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.|Participants from the safety set who had FEV1 percent predicted values at both baseline and the post baseline time points were analyzed at each given time point. The safety set included all participants who received at least one dose of study drug.|||Percent change||Standard Deviation|Mean
2667057|NCT01519661|Primary|Percentage of Participants With Treatment Emergent Adverse Events, Serious Adverse Events (SAEs) and Deaths|Adverse events were deemed treatment-emergent if the onset date/time was on or after the date and time of first study drug. All adverse events were included after this time during both on and off-treatment periods.|337 days|Safety set: The safety set included all participants who received at least one dose of study drug.|||Percentage of participants|||Number
2667058|NCT01519648|Primary|The Rate of Invasive Fungal Infections|Estimate the rate of IFIs in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.|6 month||||participants|||Number
2667059|NCT01519635|Primary|Renal Oxygenation Changes After Chronic Treatment With Aliskiren or Hydrochlorothiazide|Changes in R2* at between week 0 and week 8 as measured by BOLD MRI in the cortex and medulla of the kidney|week 0 vs week 8||||1/sec||Standard Error|Mean
2667060|NCT01519570|Secondary|Amount of Time Required by a Clinical Pharmacist to Manage This Workflow||6 months|||||||
2667061|NCT01519570|Secondary|Difference in Vaccination Rates Between Patients Who Recieved a Mailed Letter Versus a Secure Email|Difference in vaccination rates between patients sent communications via US postal service (USPS) and those sent communications via electronic patient portal (EPP)|6 months|||||||
2667062|NCT01519570|Primary|Number of Participants Who Received the Herpes Zoster Vaccine|Six months after the intervention, a second EMR report was generated to determine the change in vaccination rate of both the intervention and control groups.|6 months||||Participants|||Count of Participants
2667063|NCT01519518|Secondary|Door-to-first Device Time||28 days|||||||
2667064|NCT01519518|Secondary|Development of Thrombocytopenia||28 days|||||||
2667065|NCT01519518|Secondary|All Cause Mortality||1 year|||||||
2667066|NCT01519518|Secondary|For Illustration, and to Allow Comparison With Existing Trials the Rate of Net Adverse Clinical Events (NACE), Combining the Primary Safety and Efficacy Outcomes||28 days|||||||
2667067|NCT01519518|Secondary|Stent Thrombosis Rate (ARC Definite or Probable)||28 days||||percentage of total participants|||Number
2667068|NCT01519518|Secondary|Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition||28 days||||percentage of total participants|||Number
2667072|NCT01519466|Secondary|Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc) Scores From Day 1 to Day 60.|"The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale (-3 to +3). The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).~There is one question to assess the change in satisfaction with perceived frequency of Hypoglycaemia and one question to assess change satisfaction with perceived frequency of Hyperglycaemia. Each question is rated on a 7-point Likert scale (-3 to +3), -3 (much less satisfied) to +3 (much more satisfied).~The 95% confidence intervals for the FreeStyle InsuLinx group DTSQc scores was calculated using a one-sample t-test."|Day 60 compared to day 1|One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.|||Units on a scale||Standard Deviation|Mean
2667073|NCT01519466|Secondary|HbA1c|"HbA1c will be tested at baseline (day 1) and then again at end of study (approximately day 74).~The percentage of glycosylated hemoglobin in Diabetes Control and Complications Trial (DCCT) units was standardized to the newer International Federation of Clinical Chemistry (IFCC) units (mmol/mol)."|Day 1 compared with Day 74|One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.|||Percentage of Glycosylated Haemoglobin||Standard Deviation|Mean
2667074|NCT01519466|Primary|Time in Target Blood Glucose Range|Masked continuous glucose monitoring data will be collected for two weeks at the start of the study and 2 weeks at the end of the study. Analysis will assess the difference between the assessment and baseline phase for the intervention group. Target blood glucose range is 3.9 to 10.0mmol/l (70 to 180mg/dL)|Day 1-15 compared with Day 60-74|One FreeStyle InsuLinx group subject was excluded from the analysis due to a protocol deviation.|||hours per day||Standard Deviation|Mean
2667075|NCT01519427|Secondary|Overall Survival|Estimated probable duration of life from on-study date to date of death from any cause, using Kaplan-Meier method with censoring (see Analysis Population Description for additional details).|On-study date to date of death from any cause, up to 2 years|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where death is an event, with censoring for non-expired patients at greater of off-study date or last known alive date.|||days||Full Range|Median
2667076|NCT01519427|Secondary|Progression-free Survival (PFS)|Estimated probable duration of life without disease progression, from on-study date to earlier of progression date, or date of death from any cause, using the Kaplan-Meier method with censoring (see Analysis Population Description for additional details). Disease progression is defined by Response Evaluation in Solid Tumors (RECIST) v.1.1: >= 20% increase in sum of the longest diameter of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions|On-study to lesser of date of progression or date of death from any cause, up to 2 years|All patients are included in the analysis on intention-to-treat basis. Analysis is by Kaplan-Meier method, where either death or progression is an event, with censoring for non-progressed, non-expired patients at greater of off-study date or last known date alive.|||days||Full Range|Median
2667077|NCT01519427|Secondary|Changes in Biomarker Expression|Pre-treatment tumor biopsy tissue and blood and day 7-14 tumor biopsy tissue and blood will be examined by immunohistochemistry for expression and phosphorylation of the proteins pERK, pMEK, pAKT, Ki67, pRpS6, CRAF, cyclin D, PDGFr, pPDGFr. IGFr1, and COT/Tp12 for changes from baseline|Before initiation of treatment and at 7-14 days, up to 2 years|This clinical trial was terminated early. The investigators did not perform any biomarker expression analyses.||||||
2667078|NCT01519427|Primary|Objective Response|Number of patients in each response category, per Response Evaluation in Solid Tumors (RECIST) v.1.1: complete response (CR), disappearance of target lesions; partial response (PR) >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or PR. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.|On-treatment date to date of progressive disease (assessed up to 30 days after end of treatment)|All patients with best overall response data; patients are excluded if best overall response data is missing or if the patient is non-evaluable for best overall response.|||participants|||Number
2667079|NCT01519414|Other Pre-specified|Change in Markers of Bone Turnover in Urine|NTx and CTX will first be descriptively summarized by treatment group and also evaluated using graphical analyses to assess potential patterns over time and see if changes in bone resorption differ between those who are progression-free at 12 weeks vs. not after treatment with tivantinib. The potential impact of early changes in these markers on PFS using Cox regression models will be also explored.|Baseline to up to 6 months|||||||
2667080|NCT01519414|Other Pre-specified|Change in Bone Specific Alkaline Phosphatase (BSAP) in Serum|BSAP will first be descriptively summarized by treatment group and also evaluated using graphical analyses to assess potential patterns over time and see if changes in bone resorption differ between those who are progression-free at 12 weeks vs. not after treatment with tivantinib. The potential impact of early changes in these markers on PFS using Cox regression models will be also explored.|Baseline to up to 6 months|||||||
2667081|NCT01519414|Other Pre-specified|Radiographic Response Rate Based on RECIST Criteria|Summarized with their corresponding 95% binomial confidence intervals and compared in an exploratory manner between the two treatment arms. Dichotomized outcomes of response will be descriptively summarized and graphically evaluated using bar graphs.|Up to 12 weeks||||percentage of patients||95% Confidence Interval|Number
2667082|NCT01519414|Secondary|Incidence of Adverse Events Graded as 3, 4, or 5 Per NCI CTCAE Version 4.0|Fisher's exact tests will be used to quantitatively compare the incidence of severe as well as specific toxicities of interest between the treatment arms and graphically assessed differences in maximum grades observed for toxicities between the arms.|Up to 1 year|Adverse events graded as 3, 4 or 5 per NCI CTCAE version 4 (regardless of attribution)|||patients|||Number
2667083|NCT01519414|Secondary|PSA Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|up to 12 weeks||||percentage of patients||95% Confidence Interval|Number
2667087|NCT01519323|Secondary|Overall Survival (OS)|Overall survival was defined as the time between the date of first treatment to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of their last being known alive. Median overall survival was estimated using Kaplan-Meier method and 95% CI for median was computed using the Brookmeyer and Crowley method.|Randomization date of first subject until death (2 years)|Intent to treat population included all participants enrolled.|||days||95% Confidence Interval|Median
2667088|NCT01519323|Secondary|Progression-free Survival (PFS)|PFS was defined as the time between the day of first treatment and the first documentation of progressive disease or death. Progression was defined as a 20% increase in the sum of the longest diameter of target lesions, the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions. Participants who were withdrawn from the study without documented progression were to be censored at the date of the last known tumor assessment when the participant was known to be progression free. Median PFS was estimated using Kaplan-Meier method and 95% CI for median was computed using the Brookmeyer and Crowley method.|Randomization date of first subject until disease progression or death or which ever occur first (2 years)|Intent to treat population included all participants enrolled.|||days||95% Confidence Interval|Median
2667089|NCT01519323|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the number of participants that achieved a CR, PR or stable disease (SD) (SD for at least 6 weeks) as assessed by investigators according to the RECIST v1.1. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as at >=30% decrease under baseline of the sum of diameters of all target lesions. SD was defined as steady state of disease with neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).|Up to 2 years|Intent to treat population included all participants enrolled.|||percentage of participants|||Number
2667090|NCT01519323|Secondary|Best Overall Response Rate (BORR)|BORR was assessed by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. BORR was defined as the number of participants who achieved a complete response (CR) or partial response (PR). CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a >=30% decrease under baseline of the sum of diameters of all target lesions. BORR was summarized along with the associated exact 95% confidence interval (CI) using the method of Clopper-Pearson.|Up to 2 years|Intent to treat population included all participants enrolled.|||percentage of participants||95% Confidence Interval|Number
2667091|NCT01519323|Secondary|Number of Participants With an Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which did not necessarily have to have a causal relationship with study treatment.|Up to approximately 2 years 11 months|Safety population included all participants who received at least one dose or a partial dose of study treatment.|||participants|||Number
2667092|NCT01519323|Secondary|Area Under the Concentration-Time Curve for Vemurafenib||Pre-dose, 2, 4, 8, 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 22 (each cycle is of 28 days)|Pharmacokinetic (PK) population included all enrolled participants who received at least one dose or a partial dose of study treatment and provided at least one post-dose blood sample for PK analysis.|||hour*nanogram per millitre (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2667093|NCT01519323|Primary|Maximum Tolerated Dose (MTD)/Recommended Dose|The MTD was defined as the dose level at which six evaluable participants had been treated and at most one participant experienced a dose limiting toxicity (DLT) and the next highest dose level was too toxic. Dose escalation occurred if 0 out of 3 or at most 1 out of 6 participant experienced DLT while being treated at a dose level; otherwise the dose was declared unsafe and thus above the MTD.|Up to 28 days of treatment|A MTD could not be determined in this study because of the low number of participants enrolled.||||||
2667094|NCT01519284|Secondary|AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity|AUC0-∞ - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to infinity.|8 days||||ng.h/mL||Standard Deviation|Mean
2667095|NCT01519284|Secondary|AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification.|AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days|8 days||||ng.h/mL||Standard Deviation|Mean
2667096|NCT01519284|Secondary|Tmax - Time to Reach Maximum Plasma Concentration of Levodopa|Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days.|8 days||||hours||Full Range|Median
2667097|NCT01519284|Primary|Cmax - Maximum Plasma Concentration of Levodopa|Cmax - Maximum plasma concentration of levodopa following a single oral administration of Sinemet® 100/25 on Day 8, and 5 mg, 15 mg and 30 mg BIA 9-1067 once-daily (QD), 200 mg entacapone thrice-daily (TID), and placebo, for 8 days|8 days||||ng/mL||Standard Deviation|Mean
2667098|NCT01519271|Secondary|Montreal Cognitive Assessment (MoCA)|The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.|The MoCA was administered in the beginning and end of each study phase.|Please note this study utilized the crossover design (i.e. participants were exposed to two phases of treatment, one with placebo and one with Exelon patch). The data are comparing differences in treatment groups.|||Score on MoCA||Standard Deviation|Mean
2667110|NCT01519167|Secondary|Total Amount of Rescue Sedation (Midazolam)|Total amount of rescue sedation (midazolam) required from the start of IV sedation to completion of the procedure|During the treatment period, up to approximately 24 hours|Number of subjects who received any amount (mg) of rescue midazolam for sedation in efficacy evaluable population.|||milligram||Standard Deviation|Mean
2667111|NCT01519167|Secondary|Frequency of Fentanyl Use for Analgesia|Frequency of rescue analgesia (fentanyl) required from the start of IV sedation to completion of the procedure.|During the treatment period, up to approximately 24 hours|Number of subjects who received any amount (mg) of rescue fentanyl for analgesia in efficacy evaluable population.|||Occurrence||Full Range|Median
2667099|NCT01519271|Primary|Alzheimer's Disease Cooperative Study- Clinical Global Impression Change (ADCS-CGIC)|"The ADCS-CGIC is the most commonly used measure of global change in dementia psychopharmacology studies. This assessment is a measure of change, thus it is not appropriate for baseline administration and only administered at the end of phase visit.~The scale rates total improvement on a 7 point scale:~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse~A participant scoring a 1 or 2 is considered a responder on the CGI scale."|The ADCS-CGIC will be administered at the end of each study phase.|Please note this study utilized the crossover design (i.e. participants were exposed to two phases of treatment, one with placebo and one with Exelon patch). The data are comparing differences in treatment groups. Over the course of this study 2 participants discontinued study participation.|||scores on the CGIC||Standard Deviation|Mean
2667100|NCT01519245|Secondary|Volume of Blood Loss After 12 Hours|Volume of chest tube loss at 12 hours (assuming the total volume of loss is blood).|12 hours following admission to the Intensive Care Unit||||mL||Standard Deviation|Mean
2667101|NCT01519245|Secondary|Volume of Blood Loss at 6 Hours|Volume of chest tube loss at 6 hours (assuming the total volume of loss is blood).|6 hours following admission to the Intensive Care Unit||||mL||Standard Deviation|Mean
2667102|NCT01519245|Primary|Number of Units of Packed Red Blood Cells (PRBC) Transfused Following Coronary Artery Bypass Graft Surgery|Research participants were to receive a blood transfusion in the Intensive Care Unit (ICU) post-operatively if hemoglobin reached a nadir of 80g/L, or at the discretion of the intensivist or cardiac surgeon according to patient clinical status. Transfusion was quantified based on the number of units of PRBC received. (1 unit = 1 bag of blood, as prepared by Canadian Blood Services). Clinical status of research participants was followed throughout their duration in the ICU only. Participation in this study ended upon transfer out of the ICU, to the Cardiology Ward.|From ICU admission to transfer to the Cardiology Ward (placebo group = 24.4 hours; trial group = 24.7 hours)|None of the research participants received PRBC transfusion postoperatively in the ICU.|||Unit(s) of PRBC|||Number
2667103|NCT01519245|Primary|Total Volume of Blood Loss From Mediastinal Chest Tubes at Time of Removal (Assuming the Total Volume of Loss is Blood).|According to standard practice, research participants were be transferred to the intensive care unit (ICU) for post-operative monitoring. Measurement of chest tube output began immediately on arrival to the ICU. Hourly measurements were recorded. Data collection ended upon chest tube removal, or return to the operating room for exploratory surgery due to massive blood loss. As per ICU protocol, chest tubes were be removed when blood loss was recorded to be less than 200mL after six consecutive hours.|From ICU admission post-operatively to mediastinal chest tube removal (placebo group = 20.6 hours; trial group = 19.8 hours)|A total of 44 consented participants were randomized. Prior to unblinding, 3 of the randomized participants were withdrawn from the study due to discovery of ineligibility criteria (1 EF <50%, 1 weight <75kg, 1 CABG x 7). Therefore, a total 41 patients were included in final analysis.|||mL||Standard Deviation|Mean
2667104|NCT01519206|Secondary|Subject Satisfaction at 90 Days, 180 Days and 1 Year Post-treatment|Subject satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days, 180 days and 1 year post-treatment. Subjects indicated how satisfied they were with their study treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and post-treatment photographs were available for viewing at each follow-up visit interval. Subjects also had a mirror available for real time assessment, comparing their image in the mirror with pre-treatment and post-treatment photos.|Baseline to 90 days, 180 days and 1 year post-treatment|Three (3) subjects were lost-to-follow-up. Two (2) subjects missed the 1 year visit.|||Percentage of Participants|||Number
2667105|NCT01519206|Secondary|Subjects' Assessment of Pain|Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Subjects rated pain for each transducer, in each treatment region. For statistical analyses, NRS scores were averaged for each transducer depth.|During Ulthera treatment||||Units on a scale||Full Range|Mean
2667106|NCT01519206|Secondary|Overall Aesthetic Improvement at 60 Days, 90 Days, 180 Days and 1 Year Post-treatment.|"Improvement was assessed based on Global Aesthetic Improvement Scale (GAIS) scores. The GAIS was completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos. The PGAIS was completed by a clinician assessor; SGAIS was completed by the study subject. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse"|Baseline to 60 days, 90 days, 180 days and 1 year post-treatment|Three (3) subjects were lost-to-follow-up. Two (2) additional subjects missed the 1 year visit.|||Percentage of Participants|||Number
2667107|NCT01519206|Primary|Improvement in Overall Lifting and Tightening of Skin|Improvement in overall lifting and tightening of skin was completed by three masked assessors, completing a qualitative assessment of pre- and post-treatment photographs. Masked photo pairs of pre/post treatment photos of each treated subject were provided to each assessor. Each photo pair was consistent in lighting, position, focus. The visit interval of each photo was NOT marked. Each assessor's review was completed independently, with no input from others, assessing the photos for improvement. If improvement was seen, the blinded assessor was to choose the post-treatment photo. Categories of assessment included Improved, No Change, or Incorrect post-treatment photo chosen. The majority assessment among the 3 blinded assessors for each subject was reported.|Baseline to 90 days post treatment|Thirty-five (35) subjects were enrolled; 3 were screen failures. Thirty-two (32) subjects received study treatment. Three (3) subjects were lost-to-follow-up.|||percentage of participants improved|||Number
2667108|NCT01519167|Secondary|Number of Subjects Converted to Alternative Sedation or Anesthetic Therapy Due to Failure of Treatment of Study Drug and Rescue Medication||During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)|||Participants|||Number
2667109|NCT01519167|Secondary|Total Amount of Rescue Analgesia (Fentanyl)|Total amount of rescue analgesia (fentanyl) required from the start of IV sedation to completion of the procedure|During the treatment period, up to approximately 24 hours|Number of subjects who received any amount (mg) of rescue fentanyl for analgesia in efficacy evaluable population.|||microgram||Standard Deviation|Mean
2667113|NCT01519167|Secondary|Time to First Dose of Rescue Midazolam From Start of Dexmedetomidine Infusion|Kaplan-Meier estimates of time in minutes to first dose of rescue midazolam from onset of study drug infusion|During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)|||Hours||95% Confidence Interval|Median
2667114|NCT01519167|Secondary|Number of Subjects Who Were Adequately Sedated at Least 80% of Time|Subjects who are adequately sedated (UMSS score of 1 to 3 or NPASS score of -5 to -2) at least 80% of the time sedated with the study drug|During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)|||participants|||Number
2667115|NCT01519167|Secondary|Number of Subjects Who Have Undergone Procedures Without Artificial Ventilation or Intervention||During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)|||participants|||Number
2667116|NCT01519167|Secondary|Number of Subjects Not Receiving Rescue Midazolam|Number of subjects who did not receive any rescue midazolam for sedation during the study drug infusion.|During the treatment period, up to approximately 24 hours|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)|||participants|||Number
2667117|NCT01519167|Primary|Number of Subjects Who Had Success in Sedation|"Success in sedation was defined by a combined endpoint which was the combination of the following:~Subject had adequate level of sedation (University of Michigan Sedation Scale [UMSS] score between 1 to 3 [minimally sedated to deeply sedated] or Neonatal Pain, Agitation and Sedation Scale [N-PASS] score between -5 to -2 [Light sedation]) at least 80% of the time the subject was given the study drug.~Subject had successfully completed the procedure without a need for rescue sedation (Midazolam).~Subject had undergone the procedure without artificial ventilation or intervention to restore baseline or normal hemodynamic status"|From baseline to end of post-treatment period (approximately 24 hours)|Efficacy Evaluable Population (Participants who received study drug infusion for at least 30 minutes and had no major protocol deviations)|||participants|||Number
2667118|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
2667119|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)|The blood samples were collected at each visit for analysis of CRP with an assay analyzed by the central laboratory.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||mg/dL||Standard Deviation|Mean
2667120|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis|The rheumatologist investigator assessed how the subject's overall arthritis appeared at the time of the visit. This was an evaluation based on the subject's disease signs, functional capacity and physical examination, and was independent of the PGA of arthritis. The rheumatologist investigator's response was recorded a 100 mm visual analog scale (VAS), where 0 = very good and 100 = very poor.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
2667121|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis|"Subjects answered the following question, Considering the possible effects of the arthritis, how are you feeling today? The subject's response was recorded with a 100 mm visual analog scale (VAS), where 0 = very well and 100 = very poorly."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
2667122|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain|Subjects assessed the severity of their arthritis pain with a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (the most severe pain), which corresponded to the magnitude of their pain.|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
2667123|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count|Sixty six (66) joints were assessed for swelling by a rheumatologist investigator to determine the number of joints that were considered swelling. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Swollen joints||Standard Deviation|Mean
2667177|NCT01518257|Primary|Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8|The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.|Baseline, Week 8|Safety population included all treated participants based on the actual treatment received.|||Score on a scale||Standard Deviation|Mean
2667124|NCT01519089|Secondary|Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count|Sixty eight (68) joints were assessed by a rheumatologist investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Tender/painful joints||Standard Deviation|Mean
2667125|NCT01519089|Secondary|Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response|ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
2667126|NCT01519089|Secondary|Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response|ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
2667127|NCT01519089|Secondary|Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 2, 4, 8, 12, 20, 28, 40, 52|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
2667128|NCT01519089|Secondary|Joint Pain Assessment (JPA)|"The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to select the number that best describes any joint pain that participant may have experienced over the past 24 hours with response options ranging from 0-no joint pain to 10-worst possible joint pain."|Baseline, Week 4, 16, 28, 52|The subjects with a medical history of ongoing psoriatic arthritis (that was defined as the MedDRA preferred term for psoriatic arthropathy regardless of meeting the inclusion criteria for the psoriatic arthritis) in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
2667129|NCT01519089|Secondary|Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category|The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Percentage of participants|||Number
2667130|NCT01519089|Secondary|Work Limitation Questionnaire (WLQ)|WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands Scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).|Baseline (BL), Week (W) 4, 16, 28, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
2667131|NCT01519089|Secondary|Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score|36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).|Week 16, 28, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
2667132|NCT01519089|Secondary|Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score|36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).|Week (W) 16, 28, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
2667133|NCT01519089|Secondary|Dermatology Life Quality Index (DLQI) Score|The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
2667134|NCT01519089|Secondary|Itch Severity Item (ISI) Score|"ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate your worst itching due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms No itching (0) and Worst possible itching (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment."|Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
2667135|NCT01519089|Secondary|Number of Affected Nails|Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported.|Baseline, Week 8, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||nails||Standard Deviation|Mean
2667136|NCT01519089|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score|The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.|Week 8, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
2667137|NCT01519089|Secondary|Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported.|Week 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
2667138|NCT01519089|Secondary|Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. Maintenance of PASI75 response at Week 52 among participants achieving PASI75 response at Week 16 is reported."|Week 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
2667139|NCT01519089|Secondary|Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Percentage of participants|||Number
2667175|NCT01518257|Post-Hoc|Change From Baseline in the Average Daily Worst Pain Intensity Score in the Nociceptive Pain Group|The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.|Baseline, Weeks 4, 8 and 12|Participants from the Safety population (all treated participants based on the actual treatment received) in a subgroup of patients with nociceptive pain (pain that is caused by nerves that react to injury or damage) at Baseline.|||Score on a scale||Standard Deviation|Mean
2667140|NCT01519089|Secondary|Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 2, 4, 8, 12, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
2667141|NCT01519089|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
2667142|NCT01519089|Secondary|Change From Baseline in Psoriasis Area and Severity Index (PASI) Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Units on a scale||Standard Deviation|Mean
2667143|NCT01519089|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Percentage of participants|||Number
2667144|NCT01519089|Secondary|Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least 90% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Week||95% Confidence Interval|Median
2667145|NCT01519089|Secondary|Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Week||95% Confidence Interval|Median
2667161|NCT01519063|Primary|Craving AUC: Adlib Drinking Phase|Craving for alcohol based on Alcohol Urge Questionnaire (AUQ, Bohn et al., 1995), which is an 8 item measurement of self-reported alcohol urges that has been shown to be strongly related to alcohol dependence severity. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), with a higher score indicating higher craving. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Higher craving scores (ranging from 0-56) are indicated by larger log-transformed AUC.|50-230 minutes after the priming drink during lab session||||log (units on a scale * minutes)||Standard Deviation|Mean
2667146|NCT01519089|Secondary|Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%."|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Week||95% Confidence Interval|Median
2667147|NCT01519089|Secondary|Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs.|||Week||95% Confidence Interval|Median
2667148|NCT01519089|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least a 90 percent (%) reduction in PASI at the each visit relative to Baseline."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
2667149|NCT01519089|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least a 50 percent (%) reduction in PASI at the each visit relative to Baseline."|Week 2, 4, 8, 12, 16, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
2667150|NCT01519089|Secondary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at the each visit relative to Baseline."|Week 2, 4, 8, 12, 20, 28, 40, 52|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
2667151|NCT01519089|Primary|Number of Participants With Malignancy Events _Week 0 Through Follow-up|For all biopsies of potentially malignant tumors, suspicious lymphadenopathy, or possible extranodal LPD, the study site requested the pathologist to send the original slides used to make the definitive diagnosis, ancillary study reports, and the pathologist's report to the central laboratory for a blinded review by a central pathologist.|Baseline to Follow-up|Participants treated with at least 1 dose of study drugs.|||Participants|||Number
2667152|NCT01519089|Primary|Number of Participants With Adjudicated Cardiovacular Events|Adjudicated cardiovascular events were assessed by investigators as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; specific requirements vary with the event requiring adjudication.|Baseline to Follow-up|Participants treated with at least 1 dose of study drugs.|||Participants|||Number
2667162|NCT01519063|Primary|Number of Drinks Consumed at Lab Session (Day 7)|Number of drinks consumed during the lab session (Day 7) after taking study medication, ranging from 0-12.|Day 7||||drinks||Standard Deviation|Mean
2667153|NCT01519089|Primary|Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16|ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Week 16|Psoriatic Arthritis Population: Participants who met the inclusion criteria for the psoriatic arthritis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
2667154|NCT01519089|Primary|Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16|The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
2667155|NCT01519089|Primary|Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16|"The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at Week 16 relative to Baseline."|Week 16|Moderate to Severe Plaque Psoriasis Population: Participants who met the inclusion criteria for the moderate to severe plaque psoriasis in the Full Analysis Set (FAS). FAS included all participants randomized and treated with at least 1 dose of study drugs. Missing data was imputed as non-responder.|||Percentage of participants|||Number
2667156|NCT01519063|Primary|Stimulation Response to Alcohol: Priming Dose Phase|Brief Biphasic Alcohol Effects Scale-Stimulation subscale, measuring stimulation effects of alcohol with higher measurements indicating higher stimulation. Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. The subscale total range is 0-70, these scores are logged transformed.|0-50 minutes after priming drink||||log (units on a scale)||Standard Deviation|Mean
2667157|NCT01519063|Primary|Sedation Response to Alcohol: Priming Dose Phase|Brief Biphasic Alcohol Effects Scale-Sedation subscale, measuring sedation effects of alcohol with higher measurements indicating higher sedation. Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. The subscale total range is 0-70, these scores are logged transformed.|0-50 minutes after priming drink||||log (units on a scale)||Standard Deviation|Mean
2667158|NCT01519063|Primary|Craving AUC: Priming Dose Phase|Craving for alcohol based on Alcohol Urge Questionnaire (AUQ, Bohn et al., 1995), which is an 8 item measurement of self-reported alcohol urges that has been shown to be strongly related to alcohol dependence severity. Each item is scored from 1 (strongly disagree) to 7 (strongly agree), with a higher score indicating higher craving. Craving for alcohol based on Alcohol Urge Questionnaire is calculated using Area Under the Curve (AUC). A single summary measure, AUC was calculated for AUQ outcomes based on scores recorded at numerous time points throughout the priming drink session. The calculation was based on the trapezoidal methods using times -20, 10, 20, 30, 40, 50 minutes before/after priming drink. Based on the distribution, each AUC was log-transformed. Higher AUC levels correspond to greater alcohol urge.|0-50 minutes after the priming drink||||log (units on a scale *minutes)||Standard Deviation|Mean
2667159|NCT01519063|Primary|Sedation Response to Alcohol at Lab Session|"Brief Biphasic Alcohol Effects Scale-Sedation subscale (BAES; Martin et al., 1993), measuring sedation effects of alcohol. The seven items included on the sedation subscale range from 1 (not at all) to extremely (10) with higher measurements indicating higher sedation. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Area Under the Curve was used to calculate the final score reported for the BAES.~As a single summary measure, AUC, was calculated for BAES outcomes based on scores recorded at numerous time points throughout the adlib drinking session The calculation was based on the trapezoidal methods using times 50, 90, 110, 150, 170, 210, and 230 . Based on the distribution, each AUC was log-transformed. Higher AUC levels correspond to greater levels of sedation."|50-230 minutes after the priming drink during lab session||||log (units on a scale *minutes)||Standard Deviation|Mean
2667160|NCT01519063|Primary|Stimulation Response to Alcohol at Lab Session|Brief Biphasic Alcohol Effects Scale-Stimulation subscale (BAES; Martin et al., 1993), measuring stimulation effects of alcohol. Seven items ranging from 0 (not at all) to extremely (10) with higher measurements indicating higher stimulation. Assessed multiple times, starting at 50 minutes after priming drink until 230 minutes after priming drink. Higher stimulation scores (ranging from 0-70) are indicated by larger log-transformed AUC.|50-230 minutes after the priming drink during lab session||||log (units on a scale *minutes)||Standard Deviation|Mean
2667176|NCT01518257|Primary|Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12|The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.|Baseline, Week 12|Safety population included all treated participants based on the actual treatment received.|||Score on a scale||Standard Deviation|Mean
2667163|NCT01518946|Primary|Time to Onset of Syncope/Near Syncope While on Tilt Table|After a 30-minute supine period, the table was tilted from 0-90º within 30 seconds and maintained in that position for 45 minutes or until endpoint. Subjects were monitored for near-syncopal symptoms (subject felt sufficiently dizzy, lightheaded, faint, or felt like they were about to black out and requested the table to be returned to horizontal). Such a report ended the test. Alternatively, if the investigator observed that the subject was about to lose consciousness, that also constituted an endpoint.|1 hour post-dose|The Full Analysis Set was defined as all randomized subjects who received at least 1 dose of randomized investigational product and who had at least 1 measurement of the time to onset of syncopal symptoms/near syncope during tilt-table testing.|||seconds||Standard Error|Least Squares Mean
2667164|NCT01518530|Secondary|Efficacy as Per the NDI-Neck Disability Index|The most important instrument used to measure efficacy of treatment in patients with chronic neck pain will be used. A score of 0-50, where 50 denotes maximal disability due to chronic neck pain will be documented.|6 weeks|||||||
2667165|NCT01518530|Primary|Occiflex Device Safety|A meticulous documentation of any serious adverse effect will be made. Any minor side effects will be recorded with an emphasis on the possible relationship to the treatment. The number of minor and serious adverse effects out of 360 therapeutic sessions will be noted.|6 weeks||||Number of adverse effects|||Number
2667166|NCT01518374|Primary|Number of Participants Experiencing Treatment-emergent Adverse Events Considered Related to Florbetapir Administration|"Frequency of treatment-emergent adverse events considered related to florbetapir administration by the study investigator. Related events with a frequency > 0.2% are reported.~(note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in Adverse Events section below)"|48 hours||||Participants|||Count of Participants
2667167|NCT01518322|Post-Hoc|Of the 22 Subjects With a High FeNO (>50ppb Age 12 Years and Above; >35ppb Age Less Than 12 Years)During the Original Study Visit, Number of Subjects Subsequently Treated With Asthma Medications or Diagnosed With Asthma.|A medical record review of the 22 subjects with a high FeNO Value (>50ppb age 12 years and above; >35ppb age less than 12 years)during the original study visit was conducted. The number of subjects who were either diagnosed with asthma or treated with asthma medications is presented.|4 to 6 months after the original study visit.|Of the 162 subjects in the per-protocol population, 22 had a high FeNO (>50ppb age 12 years and above; >35ppb age less than 12 years). A retrospective medical record review was conducted and the number of subjects either diagnosed with asthma or treated with asthma medications is presented.|||participants|||Number
2667168|NCT01518322|Secondary|Subjects With a History of Cough, Wheeze, and/or Shortness of Breath Prior to the Study|The total number of subjects who reported prior episodes of cough, wheeze, and shortness of breath.|anytime prior to the single study visit|A total of 235 subjects were initially deemed eligible for the study and were identified as the All Subjects Population. Following review of the eligibility criteria and FeNO, 73 subjects were excluded from the Per Protocol Population, predominantly because of their prior asthma and COPD history and missing FeNO values.|||participants|||Number
2667169|NCT01518322|Primary|Relationship Between FeNO and the Prescription of ICS in Primary Care Practices|The total number of subjects prescribed Inhaled Corticosteroids (ICS) will be tabulated by Fractional Exhaled Nitric Oxide (FeNO). FeNO is split into high, intermediate and low categories and the associated kappa statistics and 95% confidence intervals are presented. FeNO grouping will be calculated per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low, ≥20 ppb and ≤35 ppb is intermediate, and >35 ppb is high. For those aged 12 years or older, <25 ppb is low, ≥25 ppb and ≤50 ppb is intermediate, and >50 ppb is high.|Single-visit, one (1) FeNO measurement. One (1) timepoint (Day 1)|A total of 235 subjects were initially deemed eligible for the study and were identified as the All Subjects Population. Following review of the eligibility criteria and FeNO, 73 subjects were excluded from the Per Protocol Population, predominantly because of their prior asthma and COPD history and missing FeNO values.|||participants|||Number
2667170|NCT01518322|Primary|Relationship Between FeNO and the Diagnosis of Asthma|For the primary analysis, the total number of subjects diagnosed with asthma is tabulated by Fractional Exhaled Nitric Oxide (FeNO). FeNO is split into high, intermediate and low categories and the associated kappa statistics and 95% confidence intervals are presented. FeNO grouping will be calculated per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low, ≥20 ppb and ≤35 ppb is intermediate, and >35 ppb is high. For those aged 12 years or older, <25 ppb is low, ≥25 ppb and ≤50 ppb is intermediate, and >50 ppb is high.|Single-visit, one (1) FeNO measurement. One (1) timepoint (Day 1)|A total of 235 subjects were initially deemed eligible for the study and were identified as the All Subjects Population. Following review of the eligibility criteria and FeNO, 73 subjects were excluded from the Per Protocol Population, predominantly because of their prior asthma and COPD history and missing FeNO values.|||participants|||Number
2667171|NCT01518270|Secondary|Eyelash Darkness as Measured by Digital Image Analysis (DIA)|Photographs were taken of the Eyelashes. Eyelash darkness (intensity) was measured within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white.|Baseline|All participants with values available.|||Units on a scale||Full Range|Mean
2667172|NCT01518270|Secondary|Eyelash Thickness as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes. Eyelash thickness/fullness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2).|Baseline|All participants with values available.|||Millimeters squared (mm^2)||Full Range|Mean
2667173|NCT01518270|Primary|Eyelash Length as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes. Length was measured in millimeters. Data from both eyes were averaged for each participant for analysis.|Baseline|All participants with values available.|||Millimeters (mm)||Full Range|Mean
2667174|NCT01518257|Post-Hoc|Change From Baseline in WOMAC Pain Score in the Nociceptive Pain Group|The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 8|Participants from the Safety population (all treated participants based on the actual treatment received) in a subgroup of patients with nociceptive pain (pain that is caused by nerves that react to injury or damage) at Baseline.|||Score on a scale||Standard Deviation|Mean
2667178|NCT01518257|Secondary|Patient Global Impression of Change Score|The participants rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicated worsening and positive scores indicated improvement.|Week 8|Participants from the Safety population (all treated participants based on the actual treatment received) with data available for this outcome measure.|||Score on a scale||Standard Deviation|Mean
2667179|NCT01518257|Secondary|Change From Baseline in WOMAC Physical Function Score|The WOMAC Physical Function Score included 17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty for a total possible score of 0 (best) to 170 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 8|Safety population included all treated participants based on the actual treatment received.|||Score on a scale||Standard Deviation|Mean
2667180|NCT01518257|Secondary|Change From Baseline in WOMAC Pain Score|The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 8|Safety population included all treated participants based on the actual treatment received.|||Score on a scale||Standard Deviation|Mean
2667181|NCT01518257|Secondary|Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score|The WOMAC Total Index Score consisted of 24 components rated on a scale of 0 to 10. The Total Index Score included the WOMAC Pain Score (5 questions about pain where: 0=no pain to 10=extreme pain), the WOMAC Physical Function score (17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty) and the WOMAC Stiffness Score (2 questions about stiffness where: 0=no stiffness to 10=extreme stiffness) for a total possible Index Score of 0 (best) to 240 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 8|Safety population included all treated participants based on the actual treatment received.|||Score on a scale||Standard Deviation|Mean
2667182|NCT01518257|Primary|Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4|The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.|Baseline, Week 4|Safety population included all treated participants based on the actual treatment received.|||Score on a scale||Standard Deviation|Mean
2667183|NCT01518244|Secondary|Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Week 8|The analysis population includes all participants who received AZARGA® and with at least 1 on-therapy study visit (V2 or V3).|||percentage of participants|||Number
2667184|NCT01518244|Primary|Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Baseline, Week 8|The analysis population includes all participants who received AZARGA® and with at least 1 on-therapy study visit (V2 or V3).|||milllimeters mercury (mmHg)||Standard Deviation|Mean
2667185|NCT01518192|Secondary|Selected Subjective Symptoms in Patients and Control Subjects|Comparison of the number of patients and controls with selected 8 symptoms (fatigue, arthralgias, myalgias, headache, paresthesias, dizziness, irritability, or nausea) within the preceding week, irrespective of whether they were new or increased since erythema migrans.|Examination at 12 months|all participants who followed the protocol|||participants|||Number
2667186|NCT01518192|Secondary|New or Increased Symptoms Since Erythema Migrans in Patients Controls at 12 Months.|Comparison of the number of patients and controls with new or increased symptoms since erythema migrans at 12 months.|12 months|all participants who followed the protocol|||participants|||Number
2667187|NCT01518192|Primary|Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 12 Months|Number of patients with objective Lyme disease manifestations and/or post-Lyme disease symptoms in patients treated for solitary erythema migrans at 12 months post inclusion|12 months|all participants who followed the protocol|||participants|||Number
2667188|NCT01518192|Primary|Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 6months|Number of patients with objective Lyme disease manifestations and/or post-Lyme disease symptoms in patients treated for solitary erythema migrans at 6 months post inclusion|6 months|all participants who followed the protocol|||participants|||Number
2667189|NCT01518192|Primary|Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 2 Months|Number of patients with objective Lyme disease manifestations and/or post-Lyme disease symptoms in patients treated for solitary erythema migrans at 2 months post inclusion|2 months|all participants who followed the protocol|||participants|||Number
2667190|NCT01518192|Primary|Adverse Events|Number of patients reporting adverse events|at 14 days|All participants who followed the protocol.|||participants|||Number
2667191|NCT01518192|Secondary|New or Increased Symptoms Since Erythema Migrans in Patients and Controls at 6 Months.|Comparison of the number patients and controls with new or increased symptoms since erythema migrans at 6 months.|6 months|all participants who followed the protocol|||participants|||Number
2667192|NCT01518192|Primary|Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 14 Days|Number of patients with objective manifestations of Lyme disease(persistence of erythema migrans or any of the extracutaneous-cardiac, nervous or skeletal-Lyme disease manifestations)and/or with post-Lyme disease symptoms in patients treated for solitary erythema migrans at 14 days post inclusion|at 14 days post inclusion|All participants who followed the protocol were eligible for analysis|||participants|||Number
2667193|NCT01518153|Secondary|Overall Survival (OS)|Overall Survival is defined as the interval between day of transplant and day of death.|Every 3 months until day of death|Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned DLI.|||days||Full Range|Median
2667194|NCT01518153|Primary|Success Rate|Success rate defined as alive, engrafted without grade 3 or 4 GvHD or relapse at day 100 post allogeneic stem cell transplantation followed by donor lymphocyte infusion (DLI).|100 days|Sixteen participants have been treated on study and were evaluable for treatment response. Out of 16, 7 participants met the criteria to receive planned DLI. 9 participants did not meet the criteria to receive randomized planned DLI.|||participants|||Number
2667195|NCT01517984|Secondary|Measurement of Urinary Parameters Before and After Randomization|This endpoint was unable to be analyzed because the study was terminated early after stopping rules were met.|6 months post-transplantation to 18 months post-randomization|No analyses were performed due to early study closure.||||||
2667196|NCT01517984|Secondary|Incremental Change in IF/TA Scores|This endpoint was unable to be analyzed because the study was terminated early after stopping rules were met.|6 to 18 months post-transplant|No analyses were performed due to early study closure.||||||
2667197|NCT01517984|Secondary|Percentage of Participants in the Experimental Arm Off Tacrolimus|Participants in the 'Randomized to Tacrolimus Withdrawal' group were considered fully withdrawn once they no longer received any doses of tacrolimus. Participants met this endpoint if they did not resume taking tacrolimus as of 18 months post randomization with stable allograft function and without rejection of donor-specific antibodies.|18 months post-randomization|Intent-to-treat|||percentage of participants|||Number
2667198|NCT01517984|Secondary|Percentage of Participants With Donor-Specific Memory Using Elispot|This endpoint was unable to be analyzed because the study was terminated early after stopping rules were met.|6 to 18 months post-randomization|No analyses were performed due to early study closure.||||||
2667199|NCT01517984|Secondary|Percentage of Participants With New Donor Specific Antibodies (DSAs)|Donor specific antibodies are antibodies that are directed against antigens expressed on donor organs. These antibodies can result in an immune attack on the transplanted organ, increasing risk of graft loss and/or rejection.|6 to 18 months post-randomization|Intent-to-treat|||percentage of participants|||Number
2667200|NCT01517984|Secondary|Participant Survival Rate|Number of participants who did not die within the course of this study.|6 to 18 months post-transplantation|Intent-to-treat|||participants|||Number
2667201|NCT01517984|Secondary|Allograft Survival Rate|Allograft survival is defined as participants who did not need to be re-transplanted or placed on dialysis due to the failure of their allograft transplantation during the course of this study.|6 to 18 months post-randomization|Intent-to-treat|||participants|||Number
2667202|NCT01517984|Secondary|Incidence of Acute Rejection|Acute renal allograft rejection is defined as histological reading of borderline or greater determined by the local pathology laboratory. Participants suspected of having a rejection episode on the basis of clinical signs, symptoms, or on the basis of laboratory tests, had a renal ultrasound and underwent a renal transplant biopsy. Any detection of acute cellular rejection or acute humoral rejection resulted in participants in the 'Randomized to Tacrolimus Withdrawal' group to be restarted on tacrolimus and followed per the reduced follow-up schedule of events.|6 to 18 months post-randomization|Intent-to-treat|||participants|||Number
2667203|NCT01517984|Secondary|Estimated GFR Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Equation|Estimated glomerular filtration rate (eGFR) is a test to measure the level of kidney function. In this measure, the effects of tacrolimus withdrawal on long-term kidney function was assessed by comparing absolute 24 month eGFR (18 months post-randomization) and change in eGFR from 6 to 24 months (randomization to 18 months randomization). Lower numbers indicate poorer kidney function|6 months post-transplantation, 24 months post-transplantation|Intent-to-treat|||mL/min||Standard Deviation|Mean
2667204|NCT01517984|Primary|Percentage of Participants With Incremental IF/A Scores >2 at 24 Months Post-Randomization|The investigators were not able to assess this outcome, the effect of the intervention on interstitial fibrosis/tubular atrophy (IF/TA; on a 2-year graft biopsy) due to the study's premature termination by the Data Safety Monitoring Board (DSMB) because of absence of equipoise on the basis of predetermined stopping rules.|IF/TA scores on protocol biopsies obtained at 24 months post-randomization will be compared to those obtained at the time of implantation for this measurement.|No analyses were performed due to early study closure.||||||
2667205|NCT01517893|Secondary|CXCR3 Expression on CD8+ T Cells|Determination of the effects of simvastatin treatment on CXCR3 expression in melanocyte-specific, autoreactive CD8+ T cells in the blood of patients with vitiligo treated with simvastatin versus placebo|Assessed prior to treatment and periodically while on treatment|No data collected as this outcome was abandoned due to budget constraints and strength of other study results.||||||
2667206|NCT01517893|Secondary|Serum CXCL10 Levels From the First and Last Available Clinic Visits Were Measured Via ELISA|Determination of the effects of simvastatin treatment on Serum CXCL10 levels from the first and last available clinic visits were measured via ELISA in the blood of patients with vitiligo treated with simvastatin versus placebo|Assessed at baseline and final study visit, 6 months after randomization|Serum CXCL10 levels from the first and last available clinic visits were measured via ELISA. The mean and SEM are reported here. One participant in intervention group was not included because participant withdrew before a second CXCL10 level was obtained. Other withdrawn participants were included, using the CXCL10 from their final visits.|||Fold change of baseline CXCL10 level||Standard Error|Mean
2667207|NCT01517893|Secondary|Number of Participants With an Increase in Patient's Global Assessment Score|Increase in Patient's Global Assessment Scores of 30% or more from baseline to last available visit Increase means improvement. minimum is 0% and maximum is 100%|Assessed at baseline and final study visit, 6 months after randomization|Placebo arm reports 6 instead of enrolled 7 due to failure of participant to complete assessment.|||Participants|||Count of Participants
2667208|NCT01517893|Secondary|Change in Quality of Life Score by Using DERMATOLOGY LIFE QUALITY INDEX (DLQI)|"The aim of this questionnaire is to measure how much your skin problem has affected your life. We measured change in questionnaire score from baseline to end of study (at 6 months after randomization) of subjects randomized to treatment with simvastatin versus placebo. Change was measured as a drop in score at the end of 6 months of treatment.~Minimum score is 0, maximum is 30. Higher value means worse score."|Assessed at baseline and final study visit, 6 months after randomization||||units on a scale||Standard Deviation|Mean
2667282|NCT01516879|Secondary|Percent Change From Baseline in Lipoprotein(a) at Week 52||Baseline and Week 52|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
2667209|NCT01517893|Secondary|Change in Sentinel Patch Area|"Change in percent depigmentation of sentinel patch lesion from baseline to last available study visit ( 6 months after randomization).~positive numbers mean increase or worsening of sentinel patch area negative numbers mean decrease or improvement of sentinel patch area"|Assessed at baseline and final study visit, 6 months after randomization||||cm2||Standard Deviation|Mean
2667210|NCT01517893|Secondary|Number of Participants Experiencing Toxicity From of High-dose Simvastatin .|The number of participants who experienced toxicity based upon monitored lab values (Liver Function Test) and patient symptoms for evidence of simvastatin toxicity|Assessed at baseline, then monthly until final study visit, six months after randomization.||||Participants|||Count of Participants
2667211|NCT01517893|Secondary|Number of Participants With Increase in Investigator's Global Assessment Score|"Increase in Investigator Global Assessment Scores of 30% or more from baseline to last available visit.~Increase in score means improvement. 0% is no improvement at all. 100% is complete recovery."|Assessed at baseline and final study visit, 6 months after randomization|For placebo arm, only 6 out of 7 participants reported data.|||Participants|||Count of Participants
2667212|NCT01517893|Primary|Number of Participants With a Decrease in Vitiligo Area Scoring Index (VASI) Score|"Number of participants with 33% decrease in the Vitiligo Area Scoring Index (VASI) from baseline to the last available study visit.~Decrease in VASI score means improvement. Minimum value is 0, that means no vitiligo. maximum value is 100, that means 100% of the body surface area has vitiligo (total body surface area)."|Assessed at baseline and final study visit, 6 months after randomization|Overall number of participants for intervention (5) differs from enrollment (8) due to withdraw of 3 participants on intervention arm.|||Participants|||Count of Participants
2667213|NCT01517867|Secondary|Aggregate Cost|Combined provider (based on billing records) and parent cost (based on self-report).|through end of study (up to 2 years)|Cost collected for 42 participants in Chicago Parent Program and 34 participants in Parent-Child Interaction Therapy who started treatment and were discharged, regardless of whether they completed the full treatment. Did not collect cost data from the remaining participants who enrolled in study but never attended any treatment.|||dollars||Standard Deviation|Mean
2667214|NCT01517867|Primary|Change in Child Behavior Problems|parent-report measure called The Child Behavior Checklist. Raw scores range from 0 to 198 with lower numbers being better for the child.|baseline, first follow-up (up to 2 years)|First follow-up data collected from 42 participants in Chicago Parent Program and 34 participants in Parent-Child Interaction Therapy who started treatment and were discharged, regardless of whether they completed the full treatment. Did not collect follow-up data from remaining participants who enrolled in study but never attended any treatment.|||units on a scale||Standard Deviation|Mean
2667215|NCT01517763|Secondary|Adherence (Hours of Usage Per Night) and Acceptance (Number of Drop-outs). Complaints During Follow up Calls and Visit.||On day 90 after randomization|This trial was terminated due to abrupt and unexpected closure of all study sites. All case report forms and consent forms were lost as a result and therefore, there are no results to report as no data exists.||||||
2667216|NCT01517763|Primary|Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software.||On day 90 after randomization|This trial was terminated due to abrupt and unexpected closure of all study sites. All case report forms and consent forms were lost as a result and therefore, there are no results to report as no data exists.||||||
2667217|NCT01517750|Post-Hoc|Adherence With ENT Surgeries||6 weeks after randomization||||mins||Standard Deviation|Mean
2667218|NCT01517750|Post-Hoc|Outcomes in Patients With ENT (Ears, Nose and Throat) Surgeries||6 weeks after randomization||||units on a scale||Standard Deviation|Mean
2667219|NCT01517750|Secondary|Nasopharyngeal Complaints|"Nasopharyngeal complaints (NPC) were assessed by a questionnaire. Subjects were asked to evaluate their condition on a scale from 0 (no complaints) to 5 (very strong). The following questions were asked within the questionnaire: Did you observe nasal congestion, nasal dryness, runny nose, dry mouth, and dry throat (0-5 each) during the last week. The maximal achievable sum score was 25."|6 weeks after patient randomization||||units on a scale||Standard Deviation|Mean
2667220|NCT01517750|Secondary|Functional Outcome of Sleep Questionnaire (FOSQ)|"FOSQ is a measure of the impact of the disorder on multiple activities with everyday living and how the treatment can improve these activities. There are 30 questions and for each questions you have to pick from a subscale from 0-4; 0 = I don't do this activity for other reasons, 1=Yes extremely, 2=Yes moderately, 3= Yes a little, 4 = No. Scores of each subscale will be summed up and scaled to a maximum achievable value of 20. The sum score was calculated. The value range is 0-100. A higher score means that the treatment has positively improved everyday activities."|6 weeks after patient randomization||||units on a scale||Standard Deviation|Mean
2667221|NCT01517750|Secondary|Epworth Sleepiness Score (ESS)|The ESS is a measure of daytime sleepiness and has a total of 24 points. A range from 0-9 is considered normal. A score of more than 9 is considered to have abnormal daytime sleepiness|6 weeks after patient randomization||||units on a scale||Standard Deviation|Mean
2667222|NCT01517750|Primary|Therapy Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software With and Without Heated Humidification.||6 weeks after patient randomization||||minutes||Standard Deviation|Mean
2667223|NCT01517529|Secondary|Number of Participants Who Cleared the Virus|Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses|9 months||||participants|||Number
2667224|NCT01517529|Primary|Number of Participants Who Completed Standard Treatment|Blood samples will be drawn while the subject is on treatment to measure viral load and HCV-specific immune responses.|9 months|Measure HCV viral load and HCV-specific immune responses at baseline|||participants|||Number
2667283|NCT01516879|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 52||Baseline and Week 52|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
2667284|NCT01516879|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 52||Baseline and Week 52|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
2667285|NCT01516879|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 52||Baseline and Week 52|Full analysis set|||percent change||Standard Error|Least Squares Mean
2667225|NCT01517412|Secondary|Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1, 4, 5, 6, 7 and 8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. On-treatment period for treatment satisfaction assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Missing data was imputed using LOCF. Here, number of participants analyzed = participants with both baseline and Week 24 DTSQ score assessment during on-treatment period.|Baseline, Week 24|mITT population.|||Units on a scale||Standard Error|Least Squares Mean
2667226|NCT01517412|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% And Had a 2-hour Postprandial Plasma Glucose (PPG) <140mg/dL After Breakfast or Main Meal At Week 24|On-treatment period for 2-hour PPG assessment was defined as the time from the first dose of study drug up to the day of last dose of study drug. Participants without post-baseline on-treatment values (for HbA1c and 2-hour PPG) that were no more than 30-days apart were counted as non-responders if at least one of the components (HbA1cand/or 2-hour PPG) was available and showed no response. Otherwise, they were counted as missing.|Week 24|mITT population.|||Percentage of participants|||Number
2667227|NCT01517412|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (PG<60 mg/dL [3.3 mmol/L]) During the 24-Week Treatment Period|Participants without post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart not more than 30-days apart were counted as non-responders if at least one of components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.|Week 24|mITT population.|||Percentage of participants|||Number
2667228|NCT01517412|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24|Participants without post-baseline on-treatment values for (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.|Week 24|mITT population.|||Percentage of participants|||Number
2667229|NCT01517412|Secondary|Percentage of Participants Who Reached the Target of HbA1c <7% at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (Plasma Glucose [PG] <60 mg/dL [3.3 mmol/L]) During 24-Week Treatment Period|Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemic episode with an accompanying PG<60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate if no PG measurement was available. On-treatment period for symptomatic hypoglycemia assessment was defined as time from first dose of study drug up to 1 day after last dose of study drug. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.|Week 24|mITT population.|||Percentage of participants|||Number
2667230|NCT01517412|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.|Baseline, Week 24|mITT population.|||kg||Standard Error|Least Squares Mean
2667231|NCT01517412|Secondary|Change in FPG From Baseline to Week 24|Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period.|Baseline, Week 24|mITT population.|||mmol/L||Standard Error|Least Squares Mean
2667232|NCT01517412|Secondary|Change in Average 7-point SMPG Profiles From Baseline to Week 24|Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 8, before visit Week 12 and before visit week 24. The average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.|Baseline, Week 24|mITT population.|||mmol/L||Standard Error|Least Squares Mean
2667233|NCT01517412|Secondary|Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24|Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.|Week 24|mITT population.|||Percentage of participants|||Number
2667234|NCT01517412|Primary|Change in HbA1c From Baseline to Week 24|Change in HbA1C was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.|Baseline, Week 24|Modified intent-to-treat (mITT) population: all randomized participants who received at least one dose of study drug and had both baseline and at least one post-baseline assessment of any primary or secondary efficacy endpoints, irrespective of compliance with study protocol and procedures.|||Percentage of hemoglobin||Standard Error|Least Squares Mean
2667286|NCT01516879|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 52||Baseline and Week 52|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
2667287|NCT01516879|Secondary|Percent Change From Baseline in Total Cholesterol at Week 52||Baseline and Week 52|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
2667288|NCT01516879|Secondary|Percent Change From Baseline in Total Cholesterol at Week 12||Baseline and Week 12|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
2667235|NCT01517373|Secondary|Number of Participants With Abnormal Laboratory Values|Hemoglobin,hematocrit,red blood cells(RBC) count:less than [<]0.8*lower limit of normal [LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],white blood cells(WBC):<0.6*LLN or >1.5*ULN,lymphocytes,total neutrophils:<0.8*LLN or >1.2*ULN, basophils,eosinophil,monocytes:>1.2*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>0.3*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin,direct bilirubin,indirect bilirubin:>1.5*ULN;triglycerides,cholesterol:>1.3*ULN, HDL:<0.8*LLN, LDL:>1.2*ULN,blood urea nitrogen,creatinine:>1.3*ULN,uric acid:>1.2*ULN;sodium: <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN;creatine kinase:>2.0*ULN;glucose:<0.6*LLN or >1.5*ULN,urine WBC and RBC:>= 20/High Power Field [HPF]),urine epithelial cells (>=1 HPF),urine bacteria >20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (>=1);urine(protein,nitrite,mucus,leukocyte >=1 in urine dipstick test).|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure|||participants|||Number
2667236|NCT01517373|Secondary|Change From Baseline in Body Weight at Week 2, 4, 6, 8, 12 and 14||Baseline (Day 1), Week 2, 4, 6, 8, 12, 14 (follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.|||kilogram (kg)||Standard Deviation|Mean
2667237|NCT01517373|Secondary|Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant|Median recurrence time was not to be calculated when less than 50% of the participants in a given arm experienced 1 or more HAEs.|Baseline (Day 1) up to Week 14|Data was not collected since this outcome measure was not analyzed due to infrequency of the occurrence of HAEs among the participants.||||||
2667238|NCT01517373|Secondary|Number of Hypoglycemic Events (HAE) Episodes Per Participant|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. Median of 1 and 2 events per participant was reported.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||events per participant||Full Range|Median
2667239|NCT01517373|Secondary|Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode|A hypoglycemic event was identified by characteristic symptoms or blood glucose levels. HAE was defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
2667240|NCT01517373|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to 14 days after last dose of study treatment (up to 101 days)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
2667241|NCT01517373|Secondary|Number of Participants With Increase/Decrease From Baseline Vital Signs Data|Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of >=30 millimeter of mercury (mmHg); sitting diastolic BP of >=20 mmHg and pulse rate was based on investigator's discretion.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure|||participants|||Number
2667242|NCT01517373|Secondary|Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data|Participants who met the criteria for increase from baseline in ECG data were reported. Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline value was >200 then percent change of >25% counts; if baseline value was <=200 then percent change of >50% counts]); QRS complex (percent change of >=50%); QT Fridericia's correction (QTcF) interval (change of >= 30 to <60 millisecond [msec], and change of >=60 msec).|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. N(number of participants analyzed)= participants who were evaluable for this measure.|||participants|||Number
2667243|NCT01517373|Secondary|Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used and data are presented in categories of less than 6.5 percent and less than 7 percent.|Week 12|FAS included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure.|||percentage of participants|||Number
2667244|NCT01517373|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12||Baseline (Day 1), Week 2, 4, 6, 8, 12|FAS included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2667245|NCT01517373|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported.|Baseline (Day 1), Week 2, 4, 6, 8|FAS: All randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was summarized for this measure and ‘n’ signifies participants who were evaluable at given time points for each group. Data for Week 2 had not been reported because as per protocol it was not intended to be collected.|||percentage of hemoglobin||Standard Deviation|Mean
2667246|NCT01517373|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than 6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1C was reported.|Baseline (Day 1), Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.|||percentage of hemoglobin||Standard Deviation|Mean
2667247|NCT01517295|Secondary|Peak Urine Concentration of Hydromorphone|Analyze the urine concentration of hydromorphone|Up to 4 hours||||ng/mL||Standard Deviation|Mean
2667248|NCT01517295|Secondary|Correlation of Plasma PK of Hydrocodone|Correlate the plasma pharmacokinetic profile of hydromorphone to their hydrocodone doses.|1 Month|Analysis could not be performed because plasma levels analyzed were too low for the assay chosen.||||||
2667249|NCT01517295|Primary|Peak Plasma Concentration of Hydromorphone|Determine the plasma pharmacokinetic profile of hydromorphone in chronic pain subjects taking hydrocodone within a 6 hour time frame. Note: Sensitivity of the lab test used to determine plasma hydromorphone concentrations was not sufficient. Failure to meet the lowest level of detection, all subjects plasma hydromorphone concentrations were recorded as zero at all time points.|Up to 6 hours||||ng/mL||Standard Deviation|Mean
2667250|NCT01517282|Secondary|Number of New or Enlarging T2 Lesions|T2-weighted magnetic resonance imaging (MRI) tests were performed at Weeks 8, 12, and 16 to assess the number of new or enlarging T2 brain lesions, a sign of MS activity. MRI images were assessed centrally by Synarc A/S (Hamburg, Germany).|Week 8, week 12, and week 16.|"MRIs were performed in the safety population (all patients who received at least 1 dose of MOR103 or placebo). However, MRIs at Weeks 12 and 16 were not mandatory per protocol. The number of patients evaluated at Weeks 8, 12, and 16 were:~MOR103 0.5 mg/kg: 8,8,8 MOR103 1.0 m/kg: 6,6,6 MOR103 2.0 mg/kg: 7,7,7 Placebo: 6, 4, 5"|||Number of new or enlarging T2 lesions|||Number
2667251|NCT01517282|Secondary|Number of New T1 Gadolinium-enhancing Lesions|Magnetic resonance imaging (MRI) tests were performed at screening (to confirm subject eligibility) and at Weeks 4, 8, 2, and 16. MRIs at post-screening time points were used to assess the number of new lesions as revealed by gadolinium (Gd) enhancement. Gd-enhanced MRIs reveal new brain lesions reflecting areas of active inflammation. MRI images were assessed centrally by Synarc A/S (Hamburg, Germany).|Week 4, week 8, week 12, and week 16.|"MRIs were performed in the safety population (all patients who received at least 1 dose of MOR103 or placebo). However, MRIs at Weeks 12 and 16 were not mandatory per protocol. The number of patients evaluated at Weeks 4, 8, 12, and 16 were:~MOR103 0.5 mg/kg: 8,8,8,8 MOR103 1.0 m/kg: 6,6,6,6 MOR103 2.0 mg/kg: 8,7,7,7 Placebo: 6, 6, 4, 5"|||Number of new T1 Gd-enhancing lesions|||Number
2667252|NCT01517282|Secondary|Accumulation Ratio for Area Under the MOR103 Serum Concentration Versus Time Curve (AUC) Over One Dosing Interval: Ratio of Week 10 (Last Dose) AUC to Week 0 (First Dose) AUC|At week 0 (first dose) and week 10 (last dose), serum samples were obtained at pre-dose and at 1, 2, 4, and 336 hours after start of dosing. To calculate the accumulation ratio, the apparent AUC calculated for the last dose was divided by the apparent AUC following the first dose using the described time points for each dosing. Because AUC is a summary outcome, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable.|Week 0 (first dose) and week 10 (last dose)|Pharmocokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). Data were missing for one patient in the MOR103 2.0 mg/kg group (n = 7).|||ratio of AUC values||Standard Deviation|Mean
2667253|NCT01517282|Secondary|Mean Time to Maximum MOR103 Concentration (Tmax) After the First and Last MOR103 Doses|At the week 0 (first dose) and week 10 (last dose) visits, serum samples were obtained at pre-dose and at 1, 2, and 4 hours after the dose. Tmax values for each patient were calculated based on these data, and the mean Tmax values for the dose cohort are presented here. Because Tmax refers to the time to maximum serum concentration, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable.|Week 0 (first dose) and week 10 (last dose)|Pharmocokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). PK data for the last dose were missing for one patient in the MOR103 2.0 mg/kg group (n = 7).|||hour||Standard Deviation|Mean
2667254|NCT01517282|Secondary|Mean Maximum MOR103 Concentration (Cmax) After the First and Last MOR103 Doses|At the week 0 (first dose) and week 10 (last dose) visits, serum samples were obtained at pre-dose and at 1, 2, and 4 hours after the dose. Cmax values for each patient were calculated based on these data, and the mean Cmax values for the dose cohort are presented here. Because Cmax refers to the maximum serum concentration, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable, as they represent the concentration of MOR103, but not the Cmax.|Week 0 (first dose) and week 10 (last dose)|Pharmocokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). PK data for the last dose were missing for one patient in the MOR103 2.0 mg/kg group (n = 7).|||mg/L||Standard Deviation|Mean
2667289|NCT01516879|Secondary|Percent Change From Baseline in LDL-C at Week 12|Cholesterol was measured by means of ultracentrifugation.|Baseline and Week 12|Full Analysis set|||percent change||Standard Error|Least Squares Mean
2667328|NCT01516424|Secondary|Mean Change in PANSS Symptom Scores From Baseline at Each Visit|Mean change in PANSS symptom scores from baseline at each Visit from baseline at week 8|Each Visit|||||||
2667255|NCT01517282|Secondary|Mean Serum Concentration of MOR103 Over Time|MOR103 serum levels were measured at each visit. At all visits during the dosing period (weeks 0, 2, 6, 8, and 10), serum samples were taken before MOR103 administration (pre-dose) and 1 hour after the dose. In addition, at week 0 (first dose) and week 10 (last dose), additional samples were obtained at 2 hours and 4 hours after MOR103 administration. At visits that followed the dosing period (weeks 12, 14, 16, and 20), a single serum sample was obtained at any time during the visit.|Week 0 (dose 1) to week 20 (end of study)|Pharmacokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). PK data were not available for all patients at each time point.|||mg/L||Standard Deviation|Mean
2667256|NCT01517282|Secondary|Percentages of Patients Negative for Anti-MOR103 Antibodies in Serum Samples|To assess the potential immunogenicity of MOR103, a central bioanalytical laboratory (Eurofins Medinet BV, Breda, The Netherlands) tested serum samples obtained at baseline and at 3 post-treatment time points (week 14, week 16, and week 20/end of study) for anti-MOR103 antibodies.|Baseline, week 14, week 16, and week 20/end of study|All subjects who received 1 or more dose of placebo or MOR103 (safety population). Data were missing for 1 patient each in the MOR103 1.0 mg/kg and 2.0 mg/kg groups at week 14 and week 16. Data were also missing for 1 patient in the placebo group at all post-baseline timepoints (week 14, 16, and 20).|||percentage of participants|||Number
2667257|NCT01517282|Primary|Percentages of Patients With Treatment-emergent Adverse Events (TEAEs) or Treatment-emergent Serious Adverse Events (TESAEs)|The safety of multiple doses of MOR103 in patients with relapsing-remitting or secondary progressive multiple sclerosis (MS) was assessed by evaluation of the incidence of TEAEs and TESAEs. A full listing of adverse events recorded during this trial can be found in the Adverse Events section. AEs were regarded as treatment emergent if they started on or after the first date of study drug administration or if they were present prior to the first date of study drug administration and increased in severity or relationship to study drug during the study. AEs were coded using MedDRA version 16.1|From the first dose (week 0) to study endpoint (week 20)|All subjects who received 1 or more dose of placebo or MOR103 (safety population).|||percentage of participants|||Number
2667258|NCT01517178|Primary|Degree of Output Under the Base Plate (Leakage).|Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage).|Each test product was assessed for 2 weeks.||||units on a scale|Participants|Standard Deviation|Mean
2667259|NCT01517074|Secondary|Step Changes in Scleral Inflammation According to the Standardized Photographic Grading System Developed at National Eye Institute (NEI)||Baseline and Week 52|||||||
2667260|NCT01517074|Secondary|Number of Participants Who Experience a Substantial Rise in Elevated Intraocular Pressure (IOP)|A substantial rise in intraocular pressure can be defined as ≥10 mmHg change in pressure.|Baseline and Week 52||||participants|||Number
2667261|NCT01517074|Secondary|Proportion of Participants With Loss of ≥ 15 Early Treatment Diabetic Retinopathy Study (ETDRS) Letters|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 52|||||||
2667262|NCT01517074|Secondary|Number of Participants Who Tapered Off One or More Systemic Immunosuppressive Medications or Tapered Off Prednisone (≤10 mg) After Week 16|Four (4) out of 5 participants were on immunosuppressive medications at enrollment.|Week 16 and Week 52||||participants|||Number
2667263|NCT01517074|Secondary|Number of Participants Who Experienced Systemic Toxicities||Baseline and Week 52||||participants|||Number
2667264|NCT01517074|Secondary|Number of Participants Who Experienced Ocular Toxicities||Baseline and Week 52||||participants|||Number
2667265|NCT01517074|Secondary|Mean Number of Days Between the First Injection to the Second Injection|For participants who demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection|Baseline and Week 52||||Days||Full Range|Mean
2667266|NCT01517074|Secondary|Number of Participants Needing a Second Injection|Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).|Baseline and Week 52||||participants|||Number
2667267|NCT01517074|Secondary|Median Change in Visual Acuity Via the Early Treatment Diabetic Retinopathy Study (ETDRS)|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 52|||||||
2667268|NCT01517074|Secondary|Mean Change in Visual Acuity Via the Early Treatment Diabetic Retinopathy Study (ETDRS)|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and Week 52|||||||
2667269|NCT01517074|Secondary|Number of Participants Who Experience a Disease Flare as Defined by a ≥ 1-step Increase in Scleral Inflammation|Scleral inflammation was graded following 10% Phenylephrine application with an ordinal scale of 0 (no scleral inflammation with complete blanching of vessels), 0.5+ (minimal/trace inflammation with localized pink appearance of the sclera around minimally dilated deep episcleral vessels), 1+ (mild inflammation with diffuse pink appearance of the sclera around mildly dilated deep episcleral vessels), 2+ (moderate inflammation with purplish pink appearance of the sclera with tortuous and engorged deep episcleral vessels), 3+ (severe inflammation with diffuse significant redness of sclera, the details of superficial and deep episcleral vessels can't be observed), and 4+ (necrotizing inflammation with diffuse redness of the sclera with scleral thinning and uveal show)|Baseline and Week 52||||participants|||Number
2667290|NCT01516879|Secondary|Percentage of Participants With an LDL-C Response at Week 52|An LDL-C response is defined as LDL-C level < 70 mg/dL (1.8 mmol/L) at Week 52.|Week 52|Full Analysis Set|||percentage of participants||95% Confidence Interval|Number
2667270|NCT01517074|Primary|Number of Participants Who Experience at Least 2-step Reduction or Reduction to Grade 0 of Scleral Inflammation in the Study Eye According to the National Eye Institute (NEI) Photographic Scleritis Grading System Within 8 Weeks Post-injection.|"The primary efficacy outcome was a 2-step reduction in scleritis grading out of a scale of 0 to 4+ (where 0.5+ is recognized as an ordinal step between 1+ and 0+).~Scleral inflammation was graded following 10% Phenylephrine application with an ordinal scale of 0 (no scleral inflammation with complete blanching of vessels), 0.5+ (minimal/trace inflammation with localized pink appearance of the sclera around minimally dilated deep episcleral vessels), 1+ (mild inflammation with diffuse pink appearance of the sclera around mildly dilated deep episcleral vessels), 2+ (moderate inflammation with purplish pink appearance of the sclera with tortuous and engorged deep episcleral vessels), 3+ (severe inflammation with diffuse significant redness of sclera, the details of superficial and deep episcleral vessels can't be observed), and 4+ (necrotizing inflammation with diffuse redness of the sclera with scleral thinning and uveal show)."|Baseline and Week 8||||participants|||Number
2667271|NCT01516970|Secondary|Percentage of Participants Who Developed Detectable HIV Antibodies|Seroconversion rate of HIV antibodies while receiving HIV PEP evaluated as the percentage of participants who developed detectable HIV antibodies (defined as positive) and percentage of participants who had not developed detectable HIV antibodies (defined as negative). Per protocol (PP) population included all participants in mITT (defined as all participants who were assigned to receive randomized HIV PEP and were not discontinued due to confirmation of the negative HIV infection status of the index person) excluding participants with: No indication for HIV PEP; Initiation of PEP >72 hours after injury; Discontinuation of HIV PEP due to confirmation of HIV negative status of index person and if index person bears resistant virus against HIV PEP components prescribed; incorrect HIV PEP; no intake of medication.|At Month 3|Analysis was performed on PP population. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2667272|NCT01516970|Secondary|Worst Sheehan Disability Scale (SDS) Score for the Safety Population|The Sheehan Disability Scale (SDS) assesses functional impairment in 3 inter-related domains: work/school, social and family life, using a rating scale for each item ranging from 0 (not at all) to 10 (extremely).|Month 3|The safety population included all participants who received at least 1 dose of randomized HIV PEP.|||units on a scale||Standard Deviation|Mean
2667273|NCT01516970|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) is defined to be non-treatment-emergent if the onset date of the AE was clearly before the date of first HIV PEP administration, otherwise it is considered treatment-emergent.|Up to Month 3|The safety population included all participants who received at least 1 dose of randomized HIV PEP.|||participants|||Number
2667274|NCT01516970|Primary|Number of Participants With Early Discontinuation From Randomized Human Immunodeficiency Virus Postexposure Prophylaxis (HIV PEP)|Number of participants with early discontinuation from randomized HIV PEP for any reason other than confirmation of the negative HIV infection status of the index person in participants receiving HIV PEP for at least 28 days and a maximum of 30 days was assessed. Per protocol (PP) population included all participants in modified intention-to-treat (mITT [defined as all participants who were assigned to receive randomized HIV PEP and were not discontinued due to confirmation of the negative HIV infection status of the index person]) excluding participants with: No indication for HIV PEP; Initiation of PEP >72 hours after injury; Discontinuation of HIV PEP due to confirmation of HIV negative status of index person and if index person bears resistant virus against HIV PEP components prescribed; incorrect HIV PEP; no intake of medication.|Up to 30 days|Analysis was performed on PP population.|||participants||95% Confidence Interval|Number
2667275|NCT01516892|Secondary|Change From Baseline in Headache Impact Test Questionnaire (HIT-6) Total Score|The HIT-6 measures the impact of headache and treatment on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 4-week period. The total possible score ranges from 36 (no impact) to 78 (worst impact). A negative change from Baseline indicates an improvement, and a positive change from Baseline indicates a worsening.|Baseline, Week 60, Week 108|Participants from the Analysis Population, all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit, with data available for analysis.|||score on a scale||Standard Deviation|Mean
2667276|NCT01516892|Secondary|Change From Baseline in the Frequency of Headache Days|Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 60. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.|Baseline, Week 60|Analysis Population included all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit.|||headache days||Standard Deviation|Mean
2667277|NCT01516892|Primary|Change From Baseline in the Frequency of Headache Days|Mean change from Baseline in frequency (number) of headache days during the 28 day period ending with Week 108. A headache day was defined as a day (00:00 to 23:59) for which the participant reported a headache in the patient diary with 4 or more continuous hours of headache. A negative change from Baseline indicates improvement.|Baseline, Week 108|Analysis Population included all enrolled participants who had at least one efficacy assessment at baseline or a post-baseline visit.|||headache days||Standard Deviation|Mean
2667278|NCT01516879|Secondary|Percent Change From Week 12 to Week 52 in LDL-C|Cholesterol was measured by means of ultracentrifugation.|Week 12 and Week 52|The Effect Durability Analysis Set included participants in the FAS who adhered to the scheduled study drug and had nonmissing LDL-C values at Baseline, Week 12 and Week 52.|||percent change||Standard Error|Least Squares Mean
2667279|NCT01516879|Secondary|Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 52|Cholesterol was measured by means of ultracentrifugation.|Baseline and Week 52|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
2667280|NCT01516879|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 52||Baseline and Week 52|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
2667281|NCT01516879|Secondary|Percent Change From Baseline in Triglycerides at Week 52||Baseline and Week 52|Full Analysis Set|||percent change||Standard Error|Least Squares Mean
2667295|NCT01516749|Secondary|Change in Quality of Life Assessments|"The Physician Global Assessment: The physician assessed disease activity on the visual analog scale ranging from 0mm (absent) to 100mm (worst imaginable).~The Patient Global Assessment; The patients reported overall (global) disease activity of HS. Patients were asked What is the overall activity (pain, discharge, odor, and presence of new lesions) of hidradenitis at this visit? with a scale of 0=no acitivity to 100=maximal activity."|Baseline, 8 weeks|Patients who completed 8 weeks of therapy|||units on a scale||95% Confidence Interval|Mean
2667296|NCT01516749|Primary|Change in Modified Sartorius Score|"At each study visit, the same physician (dermatologist) examined patients and recorded the following: (i) anatomical regions involved: axilla, groin, gluteal (left ⁄right) or other region, 3 points per region; (ii) numbers and scores of lesions (nodule 1 point, fistula 6 points) for each region; (iii) longest distance between two relevant lesions (or size of single lesion) in each region: < 5 cm, 1 point; 5-10 cm, 3 points; > 10 cm, 9 points; and (iv) whether all lesions are separated by normal skin: yes, 0; no (= Hurley III), 9 points.~Regional scores were summed to a total score, ranging from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement. Decreases (negative changes) from baseline indicate improvement in disease severity."|Baseline, 8 weeks|The 5 patients who completed 8 weeks of therapy|||units on a scale||95% Confidence Interval|Mean
2667297|NCT01516736|Secondary|Mortality Due to Infection|Number of patients with death due to infections|Study course (19 weeks)|FAS set = full analysis set|||Participants|||Count of Participants
2667298|NCT01516736|Secondary|Frequency of Infections by Cycle and Across All Cycles|"The number of patients with infections was recorded for each cycle and across all cycles. Infections were identified by the AE documentation page selecting all events coded with System Organ Class Infections and Infestations."|across all cycles (18 weeks)|Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set|||Participants|||Count of Participants
2667299|NCT01516736|Secondary|Time to ANC Recovery in Days in Cycle 1|Time to absolute neutrophil count (ANC) recovery was defined as the time in days from ANC nadir until the patient's ANC had increased to ≥ 2 × 10^9 cells/L after the nadir in Cycle 1.|across Cycle 1 (3 weeks)|FAS set = full analysis set|||days||Standard Deviation|Mean
2667300|NCT01516736|Secondary|Number of Patients With ANC Nadir Per Day in Cycle 1|Numbers of patients with ANC nadir based per day during Cycle 1 are given.|Cycle 1 (3 weeks)|FAS set = full analysis set|||Participants|||Count of Participants
2667301|NCT01516736|Secondary|Depth of ANC Nadir in Cycle 1|The depth of ANC nadir was defined as the patient's lowest ANC (10^9 cells/L) in Cycle 1.|Cycle 1 (3 weeks)|FAS set = full analysis set|||10^9 cells/L||Standard Deviation|Mean
2667302|NCT01516736|Secondary|Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles|Fever was defined as an oral body temperature of ≥ 38.3°C. Fever episodes were described by maximum oral temperature and the number of patients who had fever at least once.|across al cycles (18 weeks)|Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set|||Participants|||Count of Participants
2667303|NCT01516736|Secondary|Incidence of Febrile Neutropenia (FN)|"FN was defined as oral temperature ≥ 38.3°C while having an absolute neutrophil count (ANC) < 0.5 × 10^9 cells/L. Serious treatment-emergent adverse events (TEAEs) were reconciled with the fever and ANC results recorded in the patient diary and CRF and therefore only the serious TEAEs of FN (febrile neutropenia, neutropenic sepsis) were taken into account."|across all cycles (18 weeks)|FAS set = full analysis set|||Participants|||Count of Participants
2667304|NCT01516736|Primary|Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy|Mean duration of severe neutropenia, defined as number of consecutive days with ANC <0.5 × 10^9/l (grade 4 neutropenia).|21 days (Cycle 1 of chemotherapy treatment)|Missing patients in FAS set due to blind data review meeting decision (no ANC profiles available). FAS set = full analysis set; PP set = per protocol set|||days||Standard Deviation|Mean
2667305|NCT01516684|Secondary|Complications Including Any Change in Vital Signs That Requires Intervention by the Sedation Team, Post-LP Back Pain From Sedation With or Without EMLA Cream|Each patient's parent (and/or the patient) will be contacted by telephone within one week of the lumbar puncture (or in person if the next clinic visit is within one week) to ask if the patient had any back pain after the lumbar puncture, and if they had any other complications.|Within one week of the LP|Not all procedures were completed at all trials. Participants were not randomized. Trials were randomized so will use the trials to report by arm.|||Probability of experiencing back pain|Trials|Standard Error|Mean
2667306|NCT01516684|Secondary|Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration|Traumatic lumbar puncture is defined as lumbar puncture in which cerebrospinal fluid contains at least 10 red blood cells (RBCs) per microliter and bloody lumbar as one in which the cerebrospinal fluid contained at least 500 red blood cells (RBCs) per microliter.|20 minutes after lumbar puncture|Total number of trials was 136, 15 are missing. Participants were not randomized. Trials were randomized so will use the trials to report by arm.|||Trials|Trials||Count of Units
2667307|NCT01516684|Secondary|Complications Including Any Change in Vital Signs That Requires Intervention by the Sedation Team, as Well as Post-LP Headache From Sedation With or Without EMLA Cream|Each patient's parent (and/or the patient) will be contacted by telephone within one week of the lumbar puncture (or in person if the next clinic visit is within one week) to ask if the patient had any headache after the lumbar puncture, and if they had any other complications.|Within one week of the LP|Not all procedures were completed at all trials. Participants were not randomized. Trials were randomized so will use the trials to report by arm.|||Probability of experiencing headache|Trials|Standard Error|Mean
2667308|NCT01516684|Secondary|Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration||At the time of LP insertion|Participants were not randomized. Trials were randomized so we will use the trials to report by arm|||Trials|Trials||Count of Units
2667309|NCT01516684|Primary|Total Dose of Propofol Administered to Each Patient|Analyzed using descriptive statistics and mixed model regression methods. Raw mean total dose administered and raw percentage of times additional propofol was administered will be presented by sedation group treating each event (sedation with lumbar puncture) as the unit. T-test and chi-square tests will be performed as appropriate.|20 minutes after sedation|Participants were not randomized. Trials were randomized so we will have to use the trials to report by arm|||mg/kg|Trials|Standard Error|Least Squares Mean
2667312|NCT01516632|Primary|Continuous Abstinence at 3-months Assessed in Accordance With the NIH Behavior Change Consortium's Recommendations|"Continuous abstinence is defined as 5 or fewer cigarettes smoked since one's quit date. The question was asked based upon West et al., 2005: Have you smoked at all, even just a puff, since [insert quit date]? If yes, the respondent will be probed for how many cigarettes were smoked. Responses will be categorized into one of three options: A) No, not a puff; B) 1-5 cigarettes; C) More than 5 cigarettes.~Self-reported cessation is confirmed by a significant other."|3-months post-quit||||participants|||Number
2667313|NCT01516437|Secondary|Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results||At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||Subjects|||Number
2667314|NCT01516437|Secondary|Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results||At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||Subjects|||Number
2667315|NCT01516437|Secondary|Number of Subjects With Positive Sputum - Culture Testing Results||At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||Subjects|||Number
2667316|NCT01516437|Secondary|Frequency of Specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation||At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||T cells/million cells||Standard Deviation|Mean
2667317|NCT01516437|Secondary|Frequency of Specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation||At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||T cells/million cells||Standard Deviation|Mean
2667318|NCT01516437|Primary|Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%|Concentrations were expressed as geometric mean concentrations (GMCs)|At Month 6|The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.|||Subjects|||Number
2667319|NCT01516437|Primary|Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%|Concentrations were expressed as geometric mean concentrations (GMCs)|At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||Subjects|||Number
2667320|NCT01516437|Primary|Concentrations for Serum Protein-D Enzymatic Inhibition|Concentrations are presented as geometric mean concentrations (GMCs). The reference seropositivity cut-off value was ≥ 17.8%.|At Month 6|The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.|||EU/mL||95% Confidence Interval|Geometric Mean
2667321|NCT01516437|Primary|Concentrations for Serum Protein-D Enzymatic Inhibition|Concentrations are presented as geometric mean concentrations (GMCs). The reference seropositivity cut-off value was ≥ 17.8%.|At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||EU/mL||95% Confidence Interval|Geometric Mean
2667322|NCT01516437|Primary|Anti-pneumolysin Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)|At Month 6|The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.|||EU/mL||95% Confidence Interval|Geometric Mean
2667323|NCT01516437|Primary|Anti-pneumolysin Antibody Concentrations|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||EU/mL||95% Confidence Interval|Geometric Mean
2667324|NCT01516437|Primary|Anti-Pneumococcal Histidine Triad D Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)|At Month 6|The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.|||EU/mL||95% Confidence Interval|Geometric Mean
2667325|NCT01516437|Primary|Anti-Pneumococcal Histidine Triad D Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)|At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||EU/mL||95% Confidence Interval|Geometric Mean
2667326|NCT01516437|Primary|Anti-protein D Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)|At Month 6|The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.|||EU/mL||95% Confidence Interval|Geometric Mean
2667327|NCT01516437|Primary|Anti-protein D Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per millilitre (EU/mL)|At Day 0|The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.|||EU/mL||95% Confidence Interval|Geometric Mean
2667332|NCT01516424|Primary|Change From Baseline in PANSS(Positive and Negative Syndrome Scale) Total Score at Week 8|Mean change in Positive and Negative Syndrome Scale total score from baseline to Week 8 at the end of treatment. PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. It have 30 evaluation items, which include 7 positive sub-scale, 7 negative sub-scale and 16 general psychopathology sub-scale on a score of 1 to 7. The total score is the sum of the 30 scale items. The minimum score is 30 and the maximum score is 210. Patient with PANSS total scores＜70 is the normal,but the scores＞120 is more serious.Change=(Week 8 Score - Baseline score)|From baseline to the end of study、week 8(day 56)or before other antipsychotic taken.|267 subjects in participant flow, 3 subjects randomized and not treated, 2 subjects does not have baseline PANSS scale, 1 subject take Blonanserin, which randomized to Risperidone group and no PANSS scale collected after first dose. Those 6 subjects excluded from Baseline Population. The Baseline population have 261 subjects.|||score on a scale||Standard Error|Mean
2667333|NCT01516268|Primary|Narcotic Dosage|The total dosage of morphin consumed by the patients in sufentanil or control group.|over 24 hours after surgery||||mgm,.||Standard Deviation|Mean
2667334|NCT01516268|Secondary|Pain||24h|||||||
2667335|NCT01516268|Primary|Narcotic Dosage||24 h|||||||
2667336|NCT01516034|Secondary|Tolerability Score|The tolerability of the procedure will be scored by the subject using a Pain Visual Analog Scale on a 0 to 10 scale where 10 represents the highest degree of pain and 0 represents a complete lack of pain.|0, 2, 4, 6, 8, 10 weeks (after every treatment)|||||||
2667337|NCT01516034|Primary|Tattoo Removal Efficiency|"Extent of Tattoo removal is quantified in 2 methods based on photographs taken at the baseline visit and at the termination visit:~Scoring by independent dermatologist~Measuring pigment clearance using image analysis"|6 months (termination)|The number of participants that completed follow up.||||||
2667338|NCT01516008|Secondary|Patient Global Impression of Change (PGI-C) Score at 72 Hours|The PGI-C is a 7-point scale that requires the patients to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. Higher scores indicate worsening.|Baseline (Day 1) and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.|||Percentage of participants|||Number
2667339|NCT01516008|Secondary|Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours|Participants rated pain relief rated on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. PRID is the sum of pain relief and PID at the same assessment time. SPRID was calculated as the time-weighted Sum of PRID scores over 12, 24, 48, and 72 hours. Total score ranges from -120 (worst) to 168 (best) for SPRID12, -240 (worst) to 336 (best) for SPRID24, -480 (worst) to 672 (best) for SPRID48, and -720 (worst) to 1008 (best) for SPRID72. A higher value of SPRID indicates greater pain relief.|12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.|||Scores on a scale||Standard Deviation|Mean
2667340|NCT01516008|Secondary|Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours|Participants rated pain relief rated on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum of pain relief scores up to Hour 12, 24, 48, and 72 hours. Total score ranges from 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24, 0 (worst) to 192 (best) for TOTPAR48, and 0 (worst) to 288 (best) for TOTPAR72. A higher value of TOTPAR indicated greater pain relief.|12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values|||Scores on a scale||Standard Deviation|Mean
2667341|NCT01516008|Secondary|Sum of Pain Intensity Differences (SPID) Over 12, 24, and 72 Hours|Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 12, 24, and 72 hours. Total score ranges from -120 (worst) to 120 (best) for SPID12, -240 (worst) to 240 (best) for SPID24, -720 (worst) to 720 (best) for SPID72. A higher value of SPID indicates greater pain relief.|12, 24, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.|||Scores on a scale||Standard Deviation|Mean
2667342|NCT01516008|Secondary|Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours|Response rate was defined as the percentage of participants with a 50 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.|||Percentage of participants|||Number
2667343|NCT01516008|Secondary|Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours|Response rate was defined as the percentage of participants with a 30 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.|||Percentage of participants|||Number
2668950|NCT01499810|Secondary|Change in Mean Nighttime Diastolic BP Dipping|Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value|from baseline to 12 months||||percentages||Standard Deviation|Mean
2667344|NCT01516008|Secondary|Percent Reduction in Pain Intensity From Baseline at 12, 24, 48, and 72 Hours|Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.|Baseline (Day 1) and 12, 24, 48, and 72 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.|||Percentage Reduction||Inter-Quartile Range|Median
2667345|NCT01516008|Secondary|Time to First Rescue Medication Use|Rescue medication was defined as any analgesic medication used for participants discontinued due to lack of efficacy (including those started at time of discontinuation) or analgesic medication used during the double-blind period for completed participants.|Up to 48 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.|||Hours||Inter-Quartile Range|Median
2667346|NCT01516008|Primary|Sum of Pain Intensity Differences (SPID) Over 48 Hours|Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.|48 hours|Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.|||Scores on a scale||Standard Deviation|Mean
2667347|NCT01515995|Primary|Change in Forced Expiratory Volume in One Second (FEV1) %|Change in forced expiratory volume in one second (FEV1) as measured by bedside spirometry before and after study intervention.|Baseline and one hour after treatment||||Percentage of FEV1||95% Confidence Interval|Mean
2667348|NCT01515956|Secondary|Change From Baseline in Normalized Growth Rate Z-Scores|Changes in growth over time will be assessed using anthropometric measurements and radiographs of lower extremities. Z-scores are the normalized scores derived from the reference population mean and standard deviation (A positive change from baseline indicates that the population has moved closer to the reference population and represents a positive outcome).|Baseline to Week 52|Efficacy analysis set - All enrolled patients with at least 1 post treatment efficacy measurement will be included in efficacy analyses.|||z-score||Standard Deviation|Mean
2667349|NCT01515956|Secondary|Percent Change From Baseline to Week 52 in Urinary Keratan Sulfate Measures|Percent Change from Baseline to Week 52 for Urinary Keratan Sulfate measures.|Baseline to Week 52|Efficacy Analysis Set - All enrolled patients with at least 1 post treatment efficacy measurement will be included in efficacy analyses.|||percentage change||Standard Deviation|Mean
2667350|NCT01515956|Primary|To Evaluate Safety and Tolerability of Infusions of BMN 110 at a Dose of 2.0 mg/kg/Week Over a 52-week Period in MPS IVA Subjects Less Than 5 Years of Age at Time of First Study Drug Infusion|Number of Participants Experiencing Adverse Events|52 weeks|Safety Population|||Participants|||Count of Participants
2667351|NCT01515943|Secondary|Number of Participants Classified as Having Improved in All 3 Outcomes Measures From Baseline to 6 Weeks by Treatment Group|"Improvement in all 3 outcome measures at 6 weeks will be defined as follows:~Convergency Insufficiency Symptom Survey (CISS): Improvement of 9 or more points since baseline~Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763~Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419~(Note: All 3 criteria must be met in order to be classified as an improver at the 6-week visit)."|6 weeks after randomization (baseline)|The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
2667352|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria for Both Clinical Measures at 6 Weeks by Treatment Group|"The number of subjects classified as a success based on clinical measures of CI (mean NPC break & mean PFV blur) at the 6-week visit. Clinical success is defined according to whether both criteria (below) are met as follows:~Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763 and a 6-week mean NPC break <6 cm~Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419 and a 6-week mean PFV blur >15 pd"|6-weeks after randomization (baseline)|The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
2667353|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria Based on the Mean PFV Blur at 6 Weeks by Treatment Group|The number of subjects who are classified as a success based on the mean PFV blur at the 6-week visit. Success is based on the mean PFV (positive fusional vergence) blur, defined as having a mean PFV blur of >15 pd at 6 weeks and a 6-week to baseline ratio of >1.419 for mean PFV blur.|6 weeks after randomization (baseline)|The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
2667354|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria Based on the Mean NPC Break at 6 Weeks by Treatment Group|The number of subjects who are classified as a success based on the mean NPC break at the 6-week visit. Success is based on the mean NPC (near point of convergence) break is defined as having a mean NPC break of <6 cm at 6 weeks and a 6-week to baseline ratio of <0.763 for mean NPC break.|6 weeks after randomization (baseline)|The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
2667355|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria Based on CI Signs/Symptoms at 6 Weeks by Treatment Group|The number of subjects classified as a success based on signs/symptoms at the 6-week visit. Success is based on the Convergency Insufficiency Symptom Survey (CISS) defined as improvement of 9 or more points from baseline and a 6-week score of <16 points.|6 weeks after randomization (baseline)|The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
2667356|NCT01515943|Secondary|Number of Participants Classified as an Overall Success Based on the 3 Outcomes Measures From Baseline to 6 Weeks by Treatment Group|"To be considered an overall success, each of the following criteria must be met for the 3 outcome measures at 6 weeks:~Convergence Insufficiency Symptom Survey (CISS): 6-week score <16 points and at least 9-point improvement from baseline at 6 weeks~Near point of convergence (NPC) break: 6-week/baseline mean NPC break <0.763 and a mean 6-week NPC break <6 cm~Positive fusional vergence (PFV) blur: 6-week/baseline mean PFV blur >1.419 and a mean 6-week PFV break >15 pd~(Note: All 3 criteria must be met in order to be classified as an overall success at the 6-week visit)."|6 weeks after randomization (baseline)|The analysis was limited to participants who completed the 6-week visit within the pre-specified analysis window (4 to <10 weeks). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
2667357|NCT01515943|Post-Hoc|Number of Participants Classified as an Overall Success at 12 Weeks in the HB-C Group According to Whether or Not the Computer-based Therapy Program Was Completed at 12 Weeks|"This outcome was limited to participants randomly assigned to the HB-C group.~Completion of the home-based computer therapy program was defined as achieving at least 15 stars on the jump vergence therapy).~Overall success was defined as meeting the following criteria for all 3 outcome measures at 12 weeks:~Convergence Insufficiency Symptom Survey (CISS): 12-week score of <16 points and at least a 9-point improvement from baseline at 12 weeks~Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a 12-week mean NPC break <6 cm~Positive fusional vergence (PFV) blur: 12-week/ baseline mean PFV blur > 1.419 and a 12-week mean PFV blur >15 pd"|12 weeks after randomization (baseline)|The analysis was limited to participants who were randomly assigned to the HB-C group who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive).|||participants|||Number
2667358|NCT01515943|Secondary|Number of Participants Classified as Having Improved in All 3 Outcomes Measures From Baseline to 12 Weeks by Treatment Group|"Improvement in all 3 outcome measures at 12 weeks will be defined as follows:~Convergency Insufficiency Symptom Survey (CISS): Improvement of 9 or more points since baseline~Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763~Positive fusional vergence (PFV) blur: 12-week/ baseline mean PFV blur >1.419~(Note: All 3 criteria must be met in order to be classified as an improver at the 12-week primary outcome visit)."|12 weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
2667359|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria for Both Clinical Measures at 12 Weeks by Treatment Group|"The number of subjects classified as a success based on clinical measures of CI (mean NPC break & mean PFV blur) at the 12-week visit. Clinical success is defined according to whether both criteria (below) are met as follows:~Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a 12-week mean NPC break <6 cm~Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a 12-week mean PFV blur >15 pd"|12-weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
2667360|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria Based on the Mean PFV Blur at 12 Weeks by Treatment Group|The number of subjects who are classified as a success based on the mean PFV blur at the 12-week visit. Success is based on the mean PFV (positive fusional vergence) blur, defined as having a mean PFV blur of >15 pd at 12 weeks and a 12-week to baseline ratio of >1.419 for mean PFV blur.|12 weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
2667361|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria Based on the Mean NPC Break at 12 Weeks by Treatment Group|The number of subjects who are classified as a success based on the mean NPC break at the 12-week visit. Success is based on the mean NPC (near point of convergence) break is defined as having a mean NPC break of <6 cm at 12 weeks and a 12-week to baseline ratio of <0.763 for mean NPC break.|12 weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
2667362|NCT01515943|Secondary|Number of Participants Classified as Having Met Success Criteria Based on CI Signs/Symptoms at 12 Weeks by Treatment Group|The number of subjects classified as a success based on signs/symptoms at the 12-week visit. Success is based on the Convergency Insufficiency Symptom Survey (CISS) defined as improvement of 9 or more points from baseline and a 12-week score of <16 points.|12 weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive). Descriptive statistics were performed to compute the number and proportion of participants by treatment group.|||participants|||Number
2667363|NCT01515943|Primary|Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-P|"Pairwise treatment group comparison (HB-C versus Placebo) of the percentages of participants meeting success criteria using binomial regression adjusting for baseline covariates of CISS score (<28 points vs ≥ 28 points), mean NPC break (<10 cm vs ≥ 10 cm), and mean PFV blur (≥ 15 PD vs <15 PD) using linear contrasts with Bonferroni adjustment for multiple comparisons.~Overall success was defined as meeting all of the following criteria at 12 weeks:~Convergence Insufficiency Symptom Survey (CISS): 12-week score <16 points and at least 9-point improvement from baseline at 12 weeks~Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a mean 12-week NPC break <6 cm~Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a mean 12-week PFV break >15 pd"|12-weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive).|||Participants|||Count of Participants
2669670|NCT01494038|Secondary|Number of Mothers With a Fetus Small for Gestational Age|Small for gestational age was determined by physician at site|Measured at delivery|Measurement of small-for-gestational-age was deemed to be unreliable. Analysis not performed.||||||
2667364|NCT01515943|Primary|Treatment Group Comparison of the Percentage of Participants Classified as an Overall Success at 12 Weeks - HB-C Versus HB-PU|"Pairwise treatment group comparison (HB-C versus HB-PU) of the percentages of participants meeting success criteria using binomial regression adjusting for baseline covariates of CISS score (<28 points vs ≥ 28 points), mean NPC break (<10 cm vs ≥ 10 cm), and mean PFV blur (≥ 15 PD vs <15 PD) using linear contrasts with Bonferroni adjustment for multiple comparisons (Type I error rate = 2.5%).~Overall success was defined as meeting all of the following criteria at 12 weeks:~Convergence Insufficiency Symptom Survey (CISS): 12-week score <16 points and at least 9-point improvement from baseline at 12 weeks~Near point of convergence (NPC) break: 12-week/baseline mean NPC break <0.763 and a mean 12-week NPC break <6 cm~Positive fusional vergence (PFV) blur: 12-week/baseline mean PFV blur >1.419 and a mean 12-week PFV break >15 pd"|12 weeks after randomization (baseline)|The analysis was limited to participants who completed the 12-week visit within the pre-specified analysis window (10 to 18 weeks, inclusive).|||Participants|||Count of Participants
2667365|NCT01515891|Secondary|Area Under the Plasma-concentration Time Curve With Extrapolation to Infinity (AUC0-∞)|Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites|24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose||||h⋅ng-eq/mL||Standard Deviation|Mean
2667366|NCT01515891|Secondary|Area Under the Plasma-concentration Time Curve Until the Last Quantifiable Sampling Point (AUC0-t)|Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites|24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose||||h⋅ng-eq/mL||Standard Deviation|Mean
2667367|NCT01515891|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)|Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites|24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose||||hours||Standard Deviation|Mean
2667368|NCT01515891|Primary|Maximum Plasma Concentration (Cmax)|Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites|24 hours:pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose||||ng-eq/mL||Standard Deviation|Mean
2667369|NCT01515865|Primary|Percent of Subjects Who Failed to Maintain a Response|"Failure to maintain a response was defined as any randomized subject that met both criterion 1 and criterion 2 below on Day 16:~The Orthostatic Hypotension Symptom Assessment (OHSA) Item 1 score increased by >=4 points compared to baseline. OHSA Item 1 is a dizziness scale that is scored on a range from 0 (no dizziness) to 10 (severe dizziness). A lower score indicates less severe symptoms.~There was an increase in the number of syncopal/near syncopal events or severity of events within 15 minutes of standing compared to those observed at baseline. Syncope was defined as a loss of consciousness, and near syncope was defined as a feeling (e.g., dizziness, lightheadedness, feeling faint, feeling as though one would black out) that, without intervention, would lead to a loss of consciousness."|30 minutes post-dose on Day 16|The Full Analysis Set was defined as all randomized subjects who received at least 1 dose of double-blind investigational product.|||percentage of participants|||Number
2667370|NCT01515748|Secondary|Number of Participants With Shift of Laboratory Parameters (Creatinine Clearance [Chronic Kidney Disease]) From Baseline Grade to Worst NCI-CTCAE Grade >=3|NCI-CTCAE version 4.03 was used to determine Gr, where Gr refers to severity of AE: Gr 1: mild; asymptomatic/mild symptoms; Gr 2: moderate; minimal; Gr 3: severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Creatinine Clearance(Chronic kidney disease) were based on: Gr 1: estimated glomerular filtration rate (eGFR) or creatinine clearance (CrCl) <LLN-60ml/min/1.73 m^2; Gr2: eGFR or CrCl 59-30 ml/min/1.73 m^2; Gr3: eGFR or CrCl 29-15 ml/min/1.73 m^2; Gr4: eGFR or CrCl <15 ml/min/1.73 m^2; Gr5: Death.|From Baseline up to 30 days after last dose of study drug (maximum duration: up to 8 years)|Analysis was performed on safety population. Data was planned to be collected and analyzed for Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) arm only.|||Participants|||Count of Participants
2667371|NCT01515748|Secondary|Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3|NCI-CTCAE version 4.03 was used to determine Gr, where Gr refers to severity of AE: Gr 1:mild; asymptomatic/mild symptoms; Gr 2:moderate; minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Aspartate and alanine aminotransferase increased were based on Gr1: >ULN-3.0*ULN; Gr2: >3.0-5.0*ULN; Gr3: >5.0-20.0*ULN; Gr4: >20.0*ULN. Blood bilirubin increased: Gr1: >ULN-1.5*ULN; Gr2 >1.5-3.0*ULN; Gr3: >3.0-10.0*ULN; Gr4: >10.0*ULN. Alkaline phosphatase increased: Gr1: >ULN-2.5*ULN; Gr2: >2.5-5.0*ULN; Gr3: >5.0-20.0*ULN; Gr4: >20.0*ULN. Glucose (Hypoglycemia): Gr 1: <LLN-55 mg/dL; Gr2: <55-40 mg/dL;Gr3: <40-30 mg/dL; Gr4: <30 mg/dL; Gr5:Death. Glucose (Hyperglycemia): Gr 1: Fasting glucose value >ULN-160 mg/dL; Gr2: Fasting glucose value >160-250 mg/dL; Gr3: >250-500 mg/dL; Gr4: >500 mg/dL; Gr5: Death.|From Baseline up to 30 days after last dose of study drug (maximum duration: up to 8 years)|Analysis was performed on safety population.|||Participants|||Count of Participants
2667372|NCT01515748|Secondary|Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3|NCI-CTCAE version 4.03 was used to determine Gr,where Gr refers to severity of AE:Gr 1:mild; asymptomatic/mild symptoms; Gr 2:moderate;minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Calcium(Hypocalcemia) were based on Gr1: Corrected serum calcium of <LLN-8.0 mg/dL; Gr2: Corrected serum calcium of <8.0-7.0 mg/dL; Gr3: Corrected serum calcium of <7.0-6.0 mg/dL ; Gr4: Corrected serum calcium of <6.0 mg/dL;Gr5:death. Calcium(Hypercalcemia):Gr 1: Corrected serum calcium of >ULN -11.5 mg/dL; Gr2: Corrected serum calcium of >11.5-12.5 mg/dL; Gr3: Corrected serum calcium of >12.5-13.5 mg/dL; Gr4: Corrected serum calcium of >13.5 mg/dL;Gr5:Death. Creatinine increased: Gr 1: >1-1.5*baseline; >ULN-1.5*ULN; Gr2: >1.5-3.0*baseline; >1.5-3.0*ULN; Gr3: >3.0 baseline; >3.0-6.0*ULN; Gr4: >6.0 x ULN. Albumin(Hypoalbuminemia): Gr 1: <LLN-3 g/dL; Gr2: <3-2 g/dL; Gr3: <2 g/dL; Gr4:life-threatening consequences;Gr5:Death.|From Baseline up to 30 days after last dose of study drug (maximum duration: up to 8 years)|Analysis was performed on safety population.|||Participants|||Count of Participants
2667373|NCT01515748|Secondary|Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3|NCI-CTCAE version 4.03 was used to determine Gr,where Gr refers to severity of AE: Gr 1: mild; asymptomatic/mild symptoms; Gr 2: moderate; minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Sodium (Hyponatremia) were based on Gr1: <LLN-130 mmol/L; Gr3: <130-120 mmol/L; Gr4: <120 mmol/L; life-threatening consequences; Gr5: death. Sodium (Hypernatremia):Gr 1: >ULN-150 mmol/L; Gr2: >150-155 mmol/L; Gr3:>155-160 mmol/L;hospitalization; Gr4: >160 mmol/L; life-threatening consequences; Gr5: Death. Potassium (Hypokalemia): Gr 1: <LLN-3.0 mmol/L; Gr2: <LLN-3.0 mmol/L; symptomatic; intervention indicated; Gr3: <3.0-2.5 mmol/L; hospitalization indicated; Gr4: <2.5 mmol/L; life-threatening consequences; Gr5: Death; Potassium(Hyperkalemia): Gr 1: >ULN-5.5 mmol/L; Gr2: >5.5-6.0 mmol/L; Gr3: >6.0-7.0 mmol/L; hospitalization indicated; Gr4: >7.0 mmol/L; life-threatening consequences; Gr5: Death.|From Baseline up to 30 days after last dose of study drug (maximum duration: up to 8 years)|Analysis was performed on safety population.|||Participants|||Count of Participants
2667374|NCT01515748|Secondary|Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3|NCI-CTCAE version 4.03 was used to determine Grade(Gr),where Gr refers to severity of AE:Gr 1:mild; asymptomatic/mild symptoms; Gr 2:moderate;minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Hemoglobin(Hb)(Anemia) were based on Gr1:<lower limit of normal (LLN)-10.0g/dL; Gr2:<10.0-8.0g/dL; Gr3:<8.0g/dL; Gr4:life-threatening consequences;Gr5:death. Hb increased:Gr 1:increase(incr.) in >0-2g/dL above upper limit of normal(ULN);Gr2: incr. in >2-4g/dL above ULN; Gr3:incr. in >4gm/dL above ULN. White blood cell (WBC) decreased: Gr1:<LLN - 3000/mm^3;Gr2: <3000-2000/mm^3; Gr3:<2000-1000/mm^3;Gr4:<1000/mm^3. WBC (Leukocytosis):Gr3:>100,000/mm^3, Gr4:clinical manifestations of leucostasis;Gr5:Death. Abnormal Neutrophil count (ANC):- Gr1:<LLN-1500/mm^3;Gr2:<1500-1000/mm^3; Gr3: <1000-500/mm^3; Gr4:<500/mm^3. Platelet count decreased: Gr1:<LLN-75,000/mm^3;Gr2:<75,000-50,000/mm^3;Gr3:<50,000-25,000/mm^3;Gr4:<25,000/mm^3.|From Baseline up to 30 days after last dose of study drug (maximum duration: up to 8 years)|Analysis was performed on safety population.|||Participants|||Count of Participants
2667375|NCT01515748|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|TEAEs were defined as adverse events (AE) that appeared or worsened during the treatment period (up to 30 days after the last dose of the investigational product). SAE was an AE or adverse drug reaction at any dose of the investigational product that corresponded to one of the following: resulting in death or is life threatening; requiring in-patient hospitalization or prolongation of existing hospitalization; resulting in persistent or significant disability of dysfunction; resulting in congenital anomaly or birth defect; important medical event.|From randomization up to 30 days after last dose of study drug (maximum duration: up to 8 years)|Analysis was performed on safety population which included participants who were administered at least one dose of the investigational product.|||Participants|||Count of Participants
2667376|NCT01515748|Secondary|Percentage of Participants With R0 Resection|Tumor condition was explained according to the Residual Tumor (R) Classification: R0; No residual cancer (negative cross-section), R1; Microscopically observed residual cancer (positive cross-section), R2; Macroscopically observed residual cancer.|Up to 8 years|Analysis was performed on FAS population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2667377|NCT01515748|Secondary|Number of Participants With Post-Operative Pathological Stage Response|"TNM pathological stage was determined according to standardized histopathology and the American Joint Committee on Cancer (AJCC) staging system 7th Edition (Stages 0,IA,IB,IIA,IIB,IIIA,IIIB,IIIC and IV). Stage 0=carcinoma in situ with no metastatic potential; Stage IA=T1N0M0; Stage IB=T2N0M0,T1N1M0; Stage IIA=T3N0M0,T2N1M0,T1N2M0;Stage IIB=T4aN0M0,T3N1M0,T2N2M0,T1N3M0;Stage IIIA=T4aN1M0,T3N2M0,T2N3M0;Stage IIIB=T4bN0-1M0,T4aN2M0,T3N3M0;Stage IIIC=T4bN2-3M0, T4aN3M0 and Stage IV= distant metastases (M1) at diagnosis; where T denotes tumor size where T1: tumor invades lamina propria, muscularis mucosae, or submucosa; T2: invades muscularis propria; T3: invasion of subserosa; T4: T4a: penetrate serosa (visceral peritoneum) T4b: invade adjacent tissue and  N denotes nodes affected where N1:1-2 positive lymph nodes; N2:3-6 positive lymph nodes; N3: 7 or more positive lymph nodes and M denotes metastases where M0: no distant metastases. Higher stages indicates worse outcome."|Up to 8 years|Analysis was performed on FAS population. Here, ‘Overall number of participants analyzed’ = participants evaluable for this outcome measure.|||Participants|||Count of Participants
2667378|NCT01515748|Secondary|Overall Survival (OS)|Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (January 2023).|Up to 11 years||2023-01-31|01/2023||||
2667379|NCT01515748|Primary|Percentage of Participants With 3-Year Progression-Free Survival (PFS), as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1|PFS was defined as the time from randomization to objective tumor progression, or recurrence or death. Progressive disease (PD) was defined as: 1) In Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) Arm, PD was determined according to the RECIST 1.1 Criteria during the neo-adjuvant chemotherapy period; 2) Irrespective of curative resection, if an intraoperative distant metastasis was observed or a distant metastasis was reported from pathology, it was considered PD; 3) If residual cancer cells were visually identified at the resection margin during surgery but could not be completely resected (R2), it was considered PD; 4) If residual cancer cells were finally confirmed at the resection margin during postoperative histology (R1), it was considered PD; 5) In case of finding a recurrence/distant metastasis or a new lesion during follow-up after R0 complete resection, it was defined as the first tumor assessment date when it was observed.|3 years|Full Analysis Set (FAS):included all randomized participants who satisfied inclusion/exclusion criteria and had at least one tumor assessment after baseline visit (Day 0).While the CSC Arm included participants who administered at least one dose of Docetaxel+Oxaliplatin+S-1 investigational products, the SC Arm included participants who had surgery.|||percentage of participants||95% Confidence Interval|Number
2667380|NCT01515696|Post-Hoc|Necrotizing Enterocolitis|necrotizing enterocolitis stage 2a after Bell|End of study||||participants|||Number
2667381|NCT01515696|Secondary|Feeding Tolerance- Full Enteral Feedings|full enteral feeding is defined in days of life from birth until an an infant tolerates an enteral feeding volume of 140ml/kg|days of life from birth until an infant tolerates en enteral feeding volume of 140 ml/kg|per protocol|||days||Full Range|Median
2667383|NCT01515657|Primary|Time to 99% Inhibition of Serum Thromboxane (TxB2)|Aspirin's antiplatelet activity is measured by the capacity of platelets to generate serum thromboxane (a surrogate marker for inhibition of COX-1 by aspirin). Inhibition of serum thromboxane is a key marker of antiplatelet efficacy.|4 days|Pharmacodynamic (PD) Evaluable Population for Time to 99% Inhibition|||Hours||Standard Deviation|Mean
2667384|NCT01515566|Secondary|Effect of Fentanyl on Walk Distance|Ambulatory patients with breakthrough dyspnea performed a baseline 6 minute walk test (6MWT), and then received either subcutaneous fentanyl or placebo 15 minutes before a second 6MWT. The change in walk distance was documented between the first and second 6MWT.|Baseline 6 minute walk test (6MWT) to second 6MWT, up to 100 minutes for study participation.||||feet||Standard Deviation|Mean
2667385|NCT01515566|Primary|Retention Rate|Retention rate is defined as the percentage of subjects able to complete the study.|Baseline to study completion, up to 100 minutes.||||percentage of participants|||Number
2667386|NCT01515566|Secondary|Effect of Fentanyl Versus Placebo for Exercise-Induced and Breakthrough Dyspnea|"Participants receive either Fentanyl subcutaneous (SQ) 15 minutes before walking test, or Placebo (SQ) 15 minutes before walking test. During the study, trained research staff perform study assessments and monitor participant carefully throughout the study period. Six-minute walk tests were carried out following guidelines from the American Thoracic Society. The intensity of dyspnea at 0, 1, 2, 3, 4, 5 and 6 minute of each walk test were assessed using a validated numeric rating scale (NRS) ranging from 0 (no shortness of breath) to 10 (worst possible shortness of breath) and every 5 minutes during the rest period."|Baseline to 100 minutes for study participation.||||units on a scale||Standard Deviation|Mean
2667387|NCT01515540|Primary|"Pain Intensity on a Visual Analog Scale (VAS) The Scale Had Values From 0-100, Where 0 Represents no Pain and 100 Was the Worst Pain Imaginable."|"the primary hypothesis was that the lidoderm 5% patch was expected to decrease pain intensity post treatment greater than placebo patch.~A lower value on the 0-100 scale is considered to represent less pain. Higher values represent more pain. Greater than 20%-30% decrease in pain is considered clinically meaningful."|2 weeks|based on a literature search.|||peak pain intensity||Standard Deviation|Mean
2667388|NCT01515488|Secondary|Patient Satisfaction|Custom survey with 4 items capturing satisfaction with Understanding, Ease of Answering Questions, Respect for Privacy, and Overall Feelings. For each item, the lowest possible score was 1 and the highest possible score was 6. For Understanding, the lowest actual score was 2 and the highest actual score was 6. For Ease of Answering Questions, the lowest actual score was 2 and the highest actual score was 6. For Respect for Privacy the lowest actual score was 3 and the highest actual score was 6. For Overall Feelings, the lowest actual score was 3 and the highest actual score was 6. For the (unweighted) average of all 4 items, the lowest possible score was 1 and the highest possible score was 6. The lowest actual score was 3.5 and the highest actual score was 6.0.|Upon completion of triage.||||units on a scale||Standard Deviation|Mean
2667389|NCT01515488|Secondary|Accuracy of Medical History|To check for accuracy of medical history information, two RAs approached enrolled parents during the course of their ED visit in the individual patient examination rooms. The RAs conducted a brief face-to-face interview with parents and verified information from the nursing triage summary sheet (for non-kiosk users) and the printout of history sheet from the kiosk users, noting any discrepancies on a Discrepancy Rating Scale. All historical discrepancies were categorized into three groups: major discrepancy, minor discrepancy and no discrepancy.|Upon completion of triage.||||Inaccuracies||Standard Deviation|Mean
2667390|NCT01515488|Primary|Triage Time|The time it takes for the patient to be triaged, compared across the kiosk and nurse-initiated triage conditions.|From beginning of triage to completion of triage.||||Seconds||Standard Deviation|Mean
2667391|NCT01515475|Secondary|Failure to Meet Age-Normal Stereoacuity at 3 Years|Proportion who failed to meet age-normal stereoacuity. Participants were classified as failing to meet age-normal stereoacuity if near stereoacuity was below age-normal values both with and without trial frames, during initial assessment and re-test.|36 months|Overall number is the total number of patients who completed the 3-year study.|||Participants|||Count of Participants
2667392|NCT01515475|Secondary|Mean Stereoacuity|"Mean stereoacuity at 3 years was measured in log seconds of arc (log arcsec) (see explanation below). Evaluated the best of the values reported with and without trial frames, during initial assessment and retest.~Stereoacuity scores (seconds of arc) were calculated based on the Randot Preschool stereoacuity test (scores: 800, 400, 200, 100, 60 and 40). Seconds of arc refers to the visual angle that is being measured in order to determine depth perception. Lower scores indicate better stereoacuity. A logarithm base 10 transformation was used to convert stereoacuity scores to the log scale to calculate descriptive statistics (reported as seconds of arc, or arcsec). Seconds of arc were converted to logarithm of seconds of arc, or log arcsec (in parentheses) as follows: 40 (1.60), 60(1.78), 100 (2.00), 200 (2.30), 400 (2.60), 800 (2.90), Nil (3.20)"|36 months|Overall number is the total number of patients who completed the 3-year study.|||logarithm of seconds of arc (log arcsec)||Standard Deviation|Mean
2667393|NCT01515475|Secondary|Number of Participants With Strabismus at 3 Years|The number of participants who developed measurable heterotropia was estimated for each treatment group and the proportions were compared using Barnard's exact test.|36 months after randomization|In the older cohort, one participant had esotropia. In the younger cohort, Three participants in the glasses group and two in the observation group received strabismus surgery prior to the 3-year visit. These participants are included in the table.|||Participants|||Count of Participants
2667394|NCT01515475|Secondary|Binocular Near Visual Acuity|"A treatment group comparison of the mean binocular near visual acuity (logarithm of minimum angle of resolution, or logMAR) at the 36-month outcome exam will be performed. Assessment completed in randomized correction.~Snellen visual acuity (VA) equivalents were converted to logarithm of minimum angle of resolution (logMAR) equivalents (in parentheses) as follows: 20/16 (-0.1), 20/20 (0), 20/25 (0.1), 20/32 (0.2), 20/40 (0.3), 20/50 (0.4) A logMAR value of less than 0 is associated with better than 20/20 vision, while a logMAR value greater than 0 is associated with worse than 20/20 vision."|36 months after randomization|Overall number is the total number of patients who completed the 3-year study.|||logMAR||Standard Deviation|Mean
2667471|NCT01514786|Primary|Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits|Chart audits were conducted 6 months after the participant's study visit to determine if screening had occurred and if the type of screen was the same as the participant's preferred type of screening.|6 months following intervention a chart audit will be conducted to determine if CRCS was completed.||||participants|||Number
2667395|NCT01515475|Secondary|Proportion With Amblyopia (at Distance)|"A treatment group comparison of the proportion of subjects who developed amblyopia at distance during the course of the study will be performed using the Barnard's exact test.~Participants were classified as having amblyopia if any of the following criteria were met: 1) the interocular difference was ≥2 logMAR lines of IOD if VA is 20/25 or worse in the better-seeing eye, or 2) the interocular differences was ≥3 logMAR lines of IOD if VA is 20/20 or better in the better-seeing eye. 3) VA less than age normal in each eye (presumed bilateral amblyopia)"|36 months after randomization|Overall number is the total number of patients who completed the 3-year study.|||Participants|||Count of Participants
2667396|NCT01515475|Secondary|Failure to Meet Age-Normal VA at Distance|Proportion who failed to meet age-normal VA at distance at 3 years. Participants were classified as failing to meet age-normal visual acuity if, for either eye, distance visual acuity was below age-normal values both with and without trial frames, during initial assessment and re-test.|36 months|Overall number is the total number of patients who completed the 3-year study.|||Participants|||Count of Participants
2667397|NCT01515475|Secondary|Best Visual Acuity|"A treatment group comparison of the mean maximum visual acuity per subject at the masked 36-month visit (best visual acuity on any test with and without correction) will be performed using a t-test. Evaluated the best of the values reported with and without trial frames, during initial assessment and retest.~Snellen visual acuity (VA) equivalents were converted to logarithm of minimum angle of resolution (logMAR) equivalents (in parentheses) as follows: 20/16 (-0.1), 20/20 (0), 20/25 (0.1), 20/32 (0.2), 20/40 (0.3), 20/50 (0.4)~A logMAR value of less than 0 is associated with better than 20/20 vision, while a logMAR value greater than 0 is associated with worse than 20/20 vision."|36 months after randomization||||logMAR||Standard Deviation|Mean
2667398|NCT01515475|Secondary|Percentage of Participants With Hyperopia Reduction|Percentage of Participants (%) in which hyperopia reduced by 1.00D (diopters) or more over 3 years|Enrollment to 3 years|Overall number is the number of patients that completed the 3-year study in the Older Cohort. This measure was not recorded for Younger Cohort.|||percentage of participants|||Number
2667399|NCT01515475|Secondary|Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters)|"Refractive error is the measurement of the power of the lenses needed to focus light on the retina. This is measured in diopters (D). Spherical Equivalent is a pair of numbers, one for each eye, that gives an estimate of the refractive error in the eyes. Hyperopia is farsightedness, or a type of refractive error in which things are seen more clearly at a distance than at near. Myopia is nearsightedness, or refractive error in which things are seen more clearly at near.~Mean change in SE refractive error is from baseline to 3 years, measured in diopters. Negative values indicate a shift in the myopic direction."|Enrollment to 3 years|Overall number is the total number of patients who completed the 3-year study.|||diopters||95% Confidence Interval|Mean
2667400|NCT01515475|Secondary|Deterioration Criteria Met (Prior to 3 Years)|Estimate of Cumulative Deterioration Rate. Proportion of subjects who deteriorated during the course of the study were evaluated. Reasons for deterioration included stereoacuity, strabismus, treatment due to parental concern, and treatment that was prescribed against protocol.|Enrollment to <36 months||||Participants|||Count of Participants
2667401|NCT01515475|Secondary|Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters)|Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.|36 months|Total number that experienced failure, as reported in primary outcome|||Participants|||Count of Participants
2667402|NCT01515475|Secondary|Subgroup Analysis - SE Anisometropia|Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.|36 months|Total number that experienced failure, as reported in primary outcome|||Participants|||Count of Participants
2667403|NCT01515475|Secondary|Subgroup Analysis - Family History of Strabismus|Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.|36 months|Total number that experienced failure, as reported in primary outcome|||Participants|||Count of Participants
2667404|NCT01515475|Secondary|Subgroup Analysis - Family History of Amblyopia|Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.|36 months|Total number that experienced failure, as reported in primary outcome|||Participants|||Count of Participants
2667405|NCT01515475|Secondary|Subgroup Analysis - Gender|Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.|36 months|Total number that experienced failure, as reported in primary outcome|||Participants|||Count of Participants
2667406|NCT01515475|Secondary|Subgroup Analysis - Race|Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency. Total number of patients who experienced failure at 3 years are shown.|36 months after randomization|Total number that experienced failure, as reported in primary outcome|||Participants|||Count of Participants
2667407|NCT01515475|Primary|Number of Participants With Confirmation of Failure Criteria|"At the 36-month visit, each subject's condition will be classified as either failure or not a failure. The primary analytic approach will be a treatment group comparison of the proportion meeting failure criteria at 36-months using the Fisher's exact test.~The participant met failure criteria if ANY of the following criteria (except strabismus surgery prior to the 3-year outcome exam) were met during testing at the 3-year examination both with and without trial frames (without prism or bifocal), and the criteria was confirmed by a retest~Any measurable manifest strabismus in primary gaze at distance or at near not correctable with distance refractive correction alone~Strabismus surgery prior to the 36-month exam~Distance VA below age norms in either eye~≥2 logMAR lines of IOD if VA is 20/25 or worse in the better-seeing eye~≥3 logMAR lines of IOD if VA is 20/20 or better in the better-seeing eye~Stereoacuity measured at near below age normal values"|36 months after randomization|Overall number is the number of patients who completed the entire study.|||Participants|||Count of Participants
2667408|NCT01515423|Secondary|Change From Baseline in Marder Factor Subscale Score at Week 48|5 PANSS Marder factor scores (positive symptoms [range:8 to 56], negative symptoms [range: 7 to 49], disorganized thoughts [range: 7 to 49], uncontrolled hostility/excitement [range: 4 to 28], and anxiety/depression [range: 4 to 28]) were examined to gain insight into the symptoms affected by treatment with the study drug. Negative change from baseline in subscales score for positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression indicates improvement in various symptoms of schizophrenia.|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2667409|NCT01515423|Secondary|Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48|The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2667410|NCT01515423|Secondary|Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria|Symptomatic remission criterion was defined as having a simultaneous score of mild or less on all selected PANSS items (P1, P2, P3, N1, N4, N6, G5, and G9). Symptomatic remission was defined for the last 6 months of the Double-blind Phase as meeting the remission criterion during the 6 months prior to the End of study visit during the Double-blind Phase, with one excursion allowed.|Weeks 41 to 65|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2667411|NCT01515423|Secondary|Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48|The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100. Participants with a score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2667412|NCT01515423|Secondary|Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48|"The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening."|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2667413|NCT01515423|Secondary|Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48|The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).|DB Baseline (Week 17) and 48 week or DB Endpoint|mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2667414|NCT01515423|Primary|Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase|Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was <=3 at randomization; had a score of >=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization.|Up to 48 weeks|Modified intent-to-treat (mITT) analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.|||Percentage of Participants|||Number
2667415|NCT01515410|Primary|"The Primary Objective of This Study is to Explore the Efficacy and Tolerability of DM-1992 Compared to a Standard CD/LD IR Formulation as Measured by Percent OFF Time."|"OFF indicates wearing off motor fluctuations before the next levodopa dose. Percent OFF time is calculated as the total OFF time divided by the total awake time for each day and multiplied by 100.~Patient diary-every 30min while awake for 3days prior to initial Day1 as baseline & during the last 3days before Day10 for both treatments for dyskinesia state.~Baseline is the average of the 3 days recorded in the patient diary prior to Day 1 of Period 1.~End of Period is the average of the 3 days recorded in the patient diary prior to Day 10 in each period.~Clinician-Assess efficacy at pre-dose, every 30min for Day1 and hourly for Day10 for dyskinesia state & motor fluctuations at clinic visits."|Baseline and 10 days for each of the 2 study periods|Modified Intent-to-treat (ITT) Population|||percentage of time||95% Confidence Interval|Least Squares Mean
2667416|NCT01515345|Secondary|Probable Stent Thrombosis|"Probable stent thrombosis is considered to have occurred in case of~any unexplained death within the first 30 days.~any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause, irrespective of the time after the index procedure"|30days||||participants|||Number
2667417|NCT01515345|Primary|Any Bleeding Event|"Bleeding classified by the TIMI hemorrhage classification scheme:~Minor: any clinically overt sign of hemorrhage (including imaging) that is associated with a hemoglobin drop of 3 to < 5 g/dL~Major: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of > 5 g/dL"|30days||||participants|||Number
2667418|NCT01515345|Primary|Definite Stent Thrombosis|"The angiographic or pathological confirmation of stent thrombosis is called definite stent thrombosis"|30 days||||participants|||Number
2667419|NCT01515306|Secondary|Part B: Immunogenicity of Ramucirumab as Monotherapy - Incidence of Anti-Ramucirumab Antibodies||0 hour on Day 1 of Cycle 1, and 30 days after last dose of study drug||2019-12-31|12/2019||||
2667420|NCT01515306|Secondary|Part A: Immunogenicity of Ramucirumab in Combination With Paclitaxel - Incidence of Anti-Ramucirumab Antibodies||-1 hour on Day 1 of Cycle 2, and 30 days after last dose of study drug||2019-12-31|12/2019||||
2667421|NCT01515306|Secondary|Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Paclitaxel|Dose-normalized Cmax was calculated from Cmax divided by the dose.|Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion|All participants who received ramucirumab and paclitaxel and had sufficient concentration data to calculate ramucirumab Cmax in Cycle 2 of Part A.|||micrograms/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
2667422|NCT01515306|Secondary|Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Paclitaxel|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose.|Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion|All participants who received ramucirumab and paclitaxel and had sufficient concentration data to calculate ramucirumab AUC(0-∞) in Cycle 2 of Part A.|||micrograms*hour/milliliters/milligram||Geometric Coefficient of Variation|Geometric Mean
2667423|NCT01515306|Primary|Part B: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] as Monotherapy|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose.|Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72,168, 264, 336, 408, and 504 hours post ramucirumab infusion|All participants who received ramucirumab and had sufficient concentration data to calculate ramucirumab AUC(0-∞) in Cycle 1 of Part B.|||micrograms*hour/milliliter/milligram||Geometric Coefficient of Variation|Geometric Mean
2667424|NCT01515306|Primary|Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 2|Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion|All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel Cmax in Cycle 2.|||nanograms/milliliter/milligram||90% Confidence Interval|Least Squares Mean
2667425|NCT01515306|Primary|Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 1|Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion|All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel Cmax in Cycle 1.|||nanograms/milliliter/milligram||90% Confidence Interval|Least Squares Mean
2667426|NCT01515306|Primary|Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 2|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion|All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel AUC(0-∞) in Cycle 2.|||nanograms*hour/milliliter/milligram||90% Confidence Interval|Least Squares Mean
2667427|NCT01515306|Primary|Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 1|Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.|Cycle 1: 0, 1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion|All participants in drug-drug interaction (DDI) population (who completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment) and had sufficient concentration data to calculate paclitaxel AUC(0-∞) in Cycle 1.|||nanograms*hour/milliliter/milligram||90% Confidence Interval|Least Squares Mean
2668951|NCT01499810|Secondary|Change in Mean Nighttime Systolic BP Dipping|Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value|from baseline to 12 months||||difference between percentages||Standard Deviation|Mean
2667428|NCT01515189|Secondary|Overall Survival of Participants With Brain Metastases at Baseline|OS for each participant with brain metastases at baseline was measured as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median OS, and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method.|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants with brain metastases at baseline|||months||95% Confidence Interval|Median
2667429|NCT01515189|Secondary|Rate of Overall Survival|OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Survival rates were calculated based on Kaplan-Meier estimation with log-log transformed confidence intervals. The survival rate at x year(s) is defined as the probability that a subject is alive at x year(s) following randomization.|Approximately 66 months|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2667430|NCT01515189|Secondary|Duration of Stable Disease by mWHO Criteria|Duration of stable disease was defined for participants whose BOR was SD as the time between when SD was first documented and the date of PD or death (whichever occurred first). For a participant who underwent tumor resection following Week 12 but prior to disease progression, duration of stable disease was censored on the date of the last evaluable tumor assessment prior to resection. For participants who had BOR of SD at Week 12, the date of PD following thereafter (where available) was used in the analysis of duration of stable disease. For participants with BOR of SD who had not subsequently progressed and who remained alive, duration of stable disease was censored on the date of last evaluable tumor assessment. Median and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method.|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants|||months||95% Confidence Interval|Median
2667431|NCT01515189|Secondary|Duration of Response (DOR) by mWHO Criteria|Duration of response for participants whose BOR was CR or PR was defined as the time between the date measurement criteria were first met for overall response of PR or CR (whichever status was recorded first) and the date of disease progression or death (whichever occurred first). For participants who underwent tumor resection following response but prior to disease progression, duration of response was censored on the date of last evaluable tumor assessment prior to resection. For participants who had BOR of SD, PR or CR at Week 12, or a confirmed response of PR or CR before Week 12, the date of PD following thereafter (where available) was used in the analysis of duration of response. For those participants who remained alive and had not progressed following response, duration of response was censored on the date of last evaluable tumor assessment. Median and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer Crowley method.|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants|||months||95% Confidence Interval|Median
2667432|NCT01515189|Secondary|Disease Control Rate (DCR) by mWHO Criteria|"DCR by treatment arm was defined as the total number of randomized participants in the arm whose BOR is CR, PR or SD, divided by the total number of randomized participants in the arm. Any participant who was unevaluable for Disease Control (DC), (e.g. on account of missing or not evaluable assessments), was included in the denominator of the calculation (i.e. was considered a non-responder with respect to the DCR endpoint). 95% 2-sided exact confidence intervals were computed using the Clopper and Pearson method."|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants|||percentage of participants with DC||95% Confidence Interval|Number
2667433|NCT01515189|Secondary|Best Overall Response Rate (BORR) by mWHO Criteria|"BORR by treatment arm was defined as the total number of randomized participants in the arm whose BOR is CR or PR, divided by the total number of randomized participants in the arm. Any participant who was unevaluable for BOR, e.g. on account of missing or not evaluable assessments, was included in the denominator of the calculation (i.e. was considered a non-responder with respect to the BORR endpoint). 95% 2-sided exact confidence intervals were computed using the method of Clopper and Pearson."|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants|||percentage of participants with BORR||95% Confidence Interval|Number
2667434|NCT01515189|Secondary|Progression Free Survival (PFS) by mWHO Criteria|PFS was defined as the time between randomization date and the date of progression or death, whichever occurred first. A participant who died without reported prior progression was considered to have progressed on the date of death. For a participant who underwent resection post randomization, PFS was censored on last tumor assessment date prior to resection. For those who remained alive and had not progressed, PFS was censored on last evaluable tumor assessment date. Participants who had not died and had no recorded post-baseline tumor assessment were censored at the day of randomization. For participants who had Progressive Disease (PD) prior to Week 12 and a subsequent assessment of Stable Disease (SD), Partial Response (PR), or Complete Response (CR), the date of PD following response was used in the analysis of PFS; otherwise these participants were censored on the date of their last tumor assessment. Median and 2-sided 95% CIs were calculated with Brookmeyer Crowley method.|From date of randomization until 540 death events occurred (approximately 48 months)|All randomized participants.|||months||95% Confidence Interval|Median
2667435|NCT01515189|Primary|Overall Survival (OS)|OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median and associated 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley.|Approximately 48 months (assessed up to February 2016)|All randomized participants|||months||95% Confidence Interval|Median
2667436|NCT01515176|Secondary|Time to Treatment Failure|Distributions will be explored and assessed using the methods of Kaplan and Meier.|Time from study entry to the date patients end treatment, up to 28 weeks||||days||95% Confidence Interval|Median
2667437|NCT01515176|Secondary|Progression Free Survival|95% confidence intervals will be constructed using the methods of Duffy and Santner with the assumption that these rates are binomially distributed. Distributions will be explored and assessed using the methods of Kaplan and Meier.|Time from study entry to documentation of disease progression and/or death, assessed up to 5 years||||days||95% Confidence Interval|Median
2667438|NCT01515176|Secondary|Overall Survival|Distributions will be explored and assessed using the methods of Kaplan and Meier.|Time from study entry to death due to any cause, assessed up to 5 years||||days||95% Confidence Interval|Median
2667440|NCT01515176|Primary|Percentage of Patients Who Achieve an Overall Response, Defined as Achieving a Complete Response, an Unconfirmed Complete Response (SLL Only), or a Partial Response (Phase II)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 28 weeks||||percentage of patients||95% Confidence Interval|Number
2667441|NCT01515176|Primary|Number of Patients With Dose-limiting Toxicity Incidents Graded According to the NCI CTCAE v4.0 (Phase I)|Hematologic dose-limiting toxicity measures will be assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization via CTCAE version 4 standard toxicity grading. Non-hematologic dose-limiting toxicities such as dyspnea and renal will be evaluated via the ordinal CTCAE standard toxicity grading only.|Up to day 56||||Participants|||Count of Participants
2667442|NCT01515176|Primary|Maximum-tolerated Dose of Dinaciclib When Given in Combination With Ofatumumab, Defined as a Dose Level Where at Most One of 6 Evaluable Patients Has a Dose Limiting Toxicity (Phase Ia)|Graded according to the National Cancer Institute (NCI) CTCAE version (v)4.0. Assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization.|Day 56||||mg/m2|||Number
2667443|NCT01515072|Post-Hoc|Recipient Survival|Kaplan-Meier estimates of 6, 12 and 24 months survival of all recipients|Recipient survival was monitored from transplant date until death up to 2 years as in SRTR data file October 2015|All recipients of organs from donors in the RIPNOD trial and in whom recipient records are available in SRTR were included in this analysis|||percentage of participants|||Number
2667444|NCT01515072|Post-Hoc|Death-Censored Kidney Graft Survival at 6, 12 and 24 Months|kidney graft survival censored for death with functioning graft|Kidney graft survival was monitored from transplant date until retransplantation or death up to 2 years as in SRTR data file October 2015|Included were kidneys transplanted alone or with pancreas. All kidney grafts transplanted from donors in the RIPNOD trial and in whom recipient records are available in SRTR were included in this analysis. Kidney graft loss is defined as loss of functioning graft or retransplantation during the 24 months post-transplant.|||percentage of participants|||Number
2667445|NCT01515072|Post-Hoc|Graft Survival|Kaplan-Meier estimates of 6, 12 and 24 months survival of all grafts|Graft survival was monitored from transplant date until retransplantation or death up to 2 years as in SRTR data file October 2015|All grafts transplanted from donors in the RIPNOD trial and in whom recipient records are available in SRTR were included in this analysis. Graft loss is defined as retransplantation or death during the 24 months post-transplant.|||percentage of all grafts|||Number
2667446|NCT01515072|Post-Hoc|Acute Kidney Rejection|Diagnosis of rejection as documented in the recipient records in the Scientific Registry of Transplant Recipients (SRTR).|6 months after kidney transplantation|This outcome was examined in recipients of in SRTR that received kidneys from donors in the RIPNOD trial|||participants|||Number
2667447|NCT01515072|Secondary|Pulsatile Perfusion Parameters|Perfusate resistance (mm Hg/mL/min) in machine perfused kidneys.|Up to 24 hours of machine perfusion||||Resistance, mm Hg/mL/min||Standard Deviation|Mean
2667448|NCT01515072|Secondary|Delayed Graft Function (DGF) of Kidney Recipients.|DGF is defined as the need for dialysis within the first week post transplantation.|7 days post-transplant|Kidney recipients of donors in each arm.|||participants|Kidney Recipients||Number
2667449|NCT01515072|Secondary|Six Month Hospital Free Survival of All Organ Recipients|Six month hospital-free survival was defined as the number of days recipients survived following the initial discharge after the transplant.|6 months post-transplant|Recipients of all organs from donors enrolled in the two arms|||days||Inter-Quartile Range|Median
2667450|NCT01515072|Secondary|Pulsatile Perfusion Flow|Perfusate flow (mL/min) in machine perfused kidneys.|Up to 24 hours of machine perfusion||||mL/min||Standard Deviation|Mean
2667451|NCT01515072|Secondary|Change in Troponins|Change in serum troponin I (ng/mL) from before intervention to terminal value|Subjects will be followed from admission to explantation, an average of 4.5 days|Only donors in whom two troponin I values (one before intervention and another after the initial intervention) were available were included in this analysis|||ng/mL||Inter-Quartile Range|Median
2667452|NCT01515072|Secondary|Change in Dynamic Compliance|"Change in dynamic compliance of the lung from before intervention to terminal value~Cdyn = Dynamic compliance; Vt = tidal volume; PIP = Peak inspiratory pressure (the maximum pressure during inspiration); PEEP = Positive End Expiratory Pressure:~Cdyn= Vt/PIP - PEEP"|Subjects will be followed from admission to explantation, an average of 4.5 days||||L/cm H20||Inter-Quartile Range|Median
2667453|NCT01515072|Secondary|Change in P:F Ratio|Change in ratio of arterial oxygen pressure:fraction inspired oxygen ratio from before intervention to terminal value|Subjects will be followed from admission to explantation, an average of 4.5 days||||ratio||Inter-Quartile Range|Median
2667454|NCT01515072|Secondary|Change in Creatinine Clearance|Change in creatinine clearance (mL/min by Cockcroft-Gault method) from before intervention to terminal value|Subjects will be followed from admission to explantation, an average of 4.5 days|Donors in whom two serum creatinine values (one before intervention and another after the initial intervention) are available.|||mL/min||Inter-Quartile Range|Median
2667455|NCT01515072|Secondary|Change in Serum Lactate|Change in serum lactate levels (mg/dL) from before intervention to the final value|Subjects will be followed from admission to explantation, an average of 4.5 days|Donors in whom at least two serum lactate levels (one before and one after the initial intervention) were available|||mg/dL||Inter-Quartile Range|Median
2667487|NCT01514461|Secondary|Pharmacokinetics of LCQ908- Average Observed Blood Concentration (Cavg)|Average observed blood concentration measured by (AUC0-24)/24.|0, 1, 2, 3, 4, 6, and 24 hours at Week 12|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.|||ng/mL||Standard Deviation|Mean
2667488|NCT01514461|Secondary|Pharmacokinetics of LCQ908- Time to Reach Maximum Concentration Following Drug Administration Tmax (Hours)||0, 1, 2, 3, 4, 6, and 24 hours at Week 12|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.|||hours||Full Range|Median
2667456|NCT01515072|Secondary|Change in Vasopressor Score|"Changes in the following: Vasopressor usage, serum Lactate, Creatinine clearance, arterial oxygen pressure:fraction of inspired oxygen (P:F) ratios, Lung Compliance, Cardiac biomarkers, ejection fraction (EF) from 2-dimensional Echocardiogram.~Here we will present data for the change in vasopressor use evaluated using a vasopressor score.~A numerical score calculated for number and dose of Vasopressors in use. The score is calculated using the following formula (from Zuppa AF et. al.CRIT CARE MED 2004 Vol. 32 p 2318-2322):~Vasopressor Score= (dopamine dose[y=ug/kg/min x 1]) + (dobutamine dose [ug/kg/min] x 1) + (epinephrine dose [ug/kg/min] x100) + (norepinephrine dose [ug/kg/min] x 100) + (phenylephrine dose [ug/kg/min] x 100).~The range for our study was 0-4900 with higher doses indicating higher vasopressor use in the donor."|Vasopressor score was determined before aortic cross clamp minus the value prior to the first intervention, an average of 19 hours|Donors in whom vasopressor agent and dose were described in the OPO records before intervention and prior to aortic cross clamp.|||units on a scale||Inter-Quartile Range|Median
2667457|NCT01515072|Secondary|Number of Organs Transplanted Per Donor|Number of organs transplanted from each organ donor|Within 24 hours of organ recovery|Subjects were organ donors enrolled in this multicenter study|||Organs transplanted from each donor||Standard Deviation|Mean
2667458|NCT01515072|Primary|Number of Organs Recovered Per Donor|Number of organs recovered per organ donor|At time of organ recovery, up to 1 day|Subjects were organ donors enrolled in this multicenter study|||organs recovered per donor||Standard Deviation|Mean
2667459|NCT01515046|Secondary|Ascorbate Levels|Ascorbate levels will be taken at the bottom of each cycle to assess therapeutic dose window.|Once every 28 days up to 5 years|||||||
2667460|NCT01515046|Secondary|F2-isoprostane Levels|F2-isoprostane is a marker of systemic oxidative stress.|Once every 28 days for up to 5 years|Due to n=1 and study termination, the data were not analyzed.||||||
2667461|NCT01515046|Secondary|Number of Drug-related Adverse Events Per Cycle|Adverse events linked to ascorbate will be categorized and quantified using CTCAE v4 at the bottom of each cycle. Incidence and frequency will be compared to scientific literature|every 28 days up to 5 years|Due to n=1 and study termination, the data were not analyzed.||||||
2667462|NCT01515046|Secondary|Progression Free Survival|Time-to-event outcome measure (initial disease progression) measured in days from cycle 1 day 1 to day of first progression as defined by RECIST criteria from NCI.|up to 5 years||||days|||Number
2667463|NCT01515046|Primary|Overall Survival|Time to event outcome measure (death), measured in days from cycle 1 day 1.|up to 5 years||||days|||Number
2667464|NCT01514864|Secondary|Number of Participants With Laboratory Testing Results That Meet the Criteria for Grade 3 or 4 Abnormality|Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event. Laboratory values graded by Common Terminology Criteria for Adverse Events, volume 3. Hemoglobin, Grade 3: <8.0 - 6.5 g/dL, <4.9-4.0 mmol/L, <80-65 g/L. Alkaline phosphatase, Grade 3: >5.0-20.0*upper limit of normal (ULN). Total bilirubin, Grade 3: >3.0-10.0*ULN. Calcium, low, Grade 3: <7.0-6.0 mg/dL, <1.75-1.5 mmol/L.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received study drug.|||Participants|||Number
2667465|NCT01514864|Secondary|Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or unknown relationship to study drug.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received at least 1 dose of study drug|||Participants|||Number
2667466|NCT01514864|Secondary|Progression-free Survival (PFS)|PFS is defined as the time from treatment start date to the earliest evidence of disease progression or death. Patients who die or whose disease does not progress will be censored on the date of their last tumor assessment.|From Day 1 of study treatment to Week 12|All participants who received at least 1 dose of study drug|||Months||90% Confidence Interval|Median
2667467|NCT01514864|Secondary|Progression-free Survival (PFS) Distribution|PFS distribution is defined as the percentage of patients with no documentation of disease progression at a specified time point. Confidence interval computed using the Brookmeyer and Crowley method|From Day 1 of study treatment to Week 12|All participants who received at least 1 dose of study drug|||Percentage of participants||90% Confidence Interval|Median
2667468|NCT01514864|Secondary|Overall Survival|Overall survival is defined as the time from treatment start date to the date of death. If a patient does not die, survival will be censored on the last date the patient was known to be alive.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received treatment|||Months||90% Confidence Interval|Median
2667469|NCT01514864|Secondary|Duration of Response (DOR)|DOR is defined as the time from the first assessment documentation of partial response (PR) or complete response (CR) until the first assessment documentation of disease progression.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received at least 1 dose of study drug. Because no patients had a response of CR or PR, DOR could not be calculated.||||||
2667470|NCT01514864|Primary|Objective Response Rate (ORR)|ORR is defined as the percentage of patients with best tumor response of either Partial Response (a 30% or greater decrease in the sum of the longest diameter [LD] of all lesions in reference to the baseline sum LD) or Complete Response (disappearance of clinical and radiologic evidence of target lesions), according to Response Evaluation Criteria in Solid Tumors.|From enrollment of last patient to 24 months or until all patients have died, whichever occurs first|All participants who received at least 1 dose of study drug. Because no patients had a response of CR or PR, ORR could not be calculated.||||||
2667472|NCT01514760|Secondary|Asthma Control Test™ Scores|"The Asthma Control Test™ (ACT) is a 5 question health survey used to measure asthma control in individuals 12 years of age and older. The total sum scores range from 5-25. Higher scores mean that asthma is more controlled. The ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. ACT helps identify and detect asthma patients who are not well controlled. ACT scores were examined pre- and post-intervention. A score total of 19 or less means asthma may not be well controlled. The timeframe is during the past 4 weeks. The scale range for Question 1 is all the time (1) to none of the time (5); Question 2 range: more than once a day (1) to not at all (5); Question 3 range: 4 or more nights a week (1) to not at all (5); Question 4 range: 3 or more times per day (1) to not at all (5); Question 5 range: not controlled at all (1) to completely controlled (5)."|Baseline and eight weeks|All participants and participants with uncontrolled asthma at baseline. The number of participant with uncontrolled asthma 10.|||units on a scale||Standard Deviation|Mean
2667473|NCT01514760|Secondary|Asthma Self-Efficacy for Adolescent Children|"The Child Self-Efficacy instrument is a 14 item validated questionnaire designed to measure the child's self-efficacy with regard to attack prevention and attack management. The child will be required to select one of 5 responses ranging from not at all sure (1 point); a little bit sure (2 points); fairly sure (3 points); quite sure (4 points) to completely sure (5 points). Total score range from 14-70. The higher score represent a greater degree of self-efficacy. The Cronbach's α reliability = 0.75. The child self-efficacy questionnaire will be administered at baseline (pre-intervention) and at the end of the intervention (post-intervention)."|Baseline and eight weeks||||units on a scale||Standard Deviation|Mean
2667474|NCT01514760|Secondary|Number of Participants That Utilized the Asthma Action Plan|The frequency of utilization of the Asthma Action Plan for acute symptoms among the study population will be measured and compared to responses of daily prompts that will ask participants to record whether they used rescue medication.|Eight weeks||||participants|||Number
2667475|NCT01514760|Primary|Mobile Asthma Action Plan (AAP) Usage|Median number of days per week (range 0-7) the Asthma Action Plan was utilized to record routine (daily) symptoms or peak flow measurements.|Eight weeks||||days per week||Full Range|Median
2667476|NCT01514734|Primary|Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy).|Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|8 weeks||||millimeters mercury (mmHg)||Standard Deviation|Mean
2667477|NCT01514682|Secondary|Change in C-Reactive Protein (CRP)|Data was only available on 2 of the 9 cytokines (i.e., IL-2 and IL-8) and C-Reactive Protein (CRP). The baseline values for the other cytokines in the panel were below the level of detection.|A cytokine profile will be collected at baseline and at week 12 (end-of-study).|Participants who had a cytokine profile collected.|||ng/ml||Standard Deviation|Mean
2667478|NCT01514682|Secondary|Change in Pro-inflammatory Cytokines|Data was only available on 2 of the 9 cytokines (i.e., IL-2 and IL-8) and C-Reactive Protein (CRP). The baseline values for the other cytokines in the panel were below the level of detection.|A cytokine profile will be collected at baseline and at week 12 (end-of-study).|Participants who had a cytokine profile collected.|||pg/ml||Standard Deviation|Mean
2667479|NCT01514682|Secondary|Change in Negative Symptoms|The Scale for the Assessment of Negative Symptoms (SANS) total score, minus the global items, inappropriate affect, poverty of content of speech, and attention items, used to measure negative symptoms. Median SANS total score by treatment and week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.|Baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks.|Participants completing the SANS rating assessment.|||units on a scale||Inter-Quartile Range|Median
2667480|NCT01514682|Secondary|Change in Depressive Symptoms|"The Calgary Depression Scale (CDS) total score will be used to measure depressive symptoms. Total score calculated by adding scores for scales #1-#9. Each scale ranges from 0=Absent to 3=Severe. The minimum total CDS score is 0 and the maximum total CDS score is 27. A higher score indicates a more severe depression rating."|The CDS was administered at baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks.|Participants completing the CDS assessment rating.|||units on a scale||Inter-Quartile Range|Median
2667481|NCT01514682|Primary|Change in Neuropsychological Test Performance|The MATRICS Consensus Cognitive Battery (MCCB) composite score by week ranging from -10-100 with a higher score indicating a better outcome.|The MCCB was administered at baseline and end-of-study (Week 12).|Participants completing the MCCB testing.|||units on a scale||Inter-Quartile Range|Median
2667482|NCT01514682|Primary|Change in Persistent Positive Symptoms|"The Brief Psychiatric Rating Scale (BPRS) positive symptom items are: conceptual disorganization, hallucinatory behavior, unusual thought content, and suspiciousness. The total score is calculated by adding the scores for each item. Each scale ranges from 1=Not Present to 7=Very Severe. The minimum score is 4 and the maximum score is 28. A higher score indicates a more severe positive symptom rating."|The BPRS will be administered at baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks.|Participants completing the BPRS assessment rating.|||units on a scale||Inter-Quartile Range|Median
2667483|NCT01514630|Primary|HAMD Rating Scores|"Eight weeks of oral creatine supplementation will result in improvements in Hamilton Depression Rating Scale (HAMD) in female methamphetamine users. HAMD scoring is based on 17 items. Minimum score is 0 and maximum 52. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate or severe depression.~0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥ 23 = Very Severe Depression"|Over the course of eight weeks. Depression rating scores will be measured weekly for eight weeks for each subject enrolled.||||Units on a scale||Standard Deviation|Mean
2667484|NCT01514513|Secondary|Adverse Events|Number of participants with adverse events|15 days||||participants|||Number
2667485|NCT01514513|Primary|The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice|No live lice 15 days following initial treatment|15 days||||participants|||Number
2667486|NCT01514461|Secondary|Number of Patients Reported With Any Adverse Event, Serious Adverse Event and Death||52 weeks|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.|||Participants|||Number
2667489|NCT01514461|Secondary|Pharmacokinetics of LCQ908- Area Under the Plasma Concentration Time Curve AUC (0-24hour)|The area under the concentration-time curve from time zero to 24 hours after drug administration was calculated by using linear trapezoidal rule.|0, 1, 2, 3, 4, 6, and 24 hours at Week 12|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment|||ng/mL *hr||Standard Deviation|Mean
2667490|NCT01514461|Secondary|Pharmacokinetics of LCQ908 - Trough Concentration (Cmin) and Observed Maximum Blood Concentration (Cmax)|Lowest observed blood concentration (Cmin) and observed maximum blood concentration (Cmax) following drug administration derived from non-compartmental analysis using scheduled sampling time for the whole dataset.|0, 1, 2, 3, 4, 6, and 24 hours at Week 12|Safety set (SAF) consisted of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment|||ng/mL||Standard Deviation|Mean
2667491|NCT01514461|Secondary|Percent Change From Baseline for Postprandial Triglycerides Following the Standardized Meal Tolerance Test at Week 12|Post prandial peak triglycerides - maximum triglyceride value over 0-24 hours Post prandial triglycerides AUC0-24 - area under the time curve for triglycerides over 0-24 Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressed as a percentage change from baseline. hours|0-24 hours at Baseline, Week 12|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized. For each category, the number of randomized patients who have non-missing values are included in this analysis.|||Percent change||95% Confidence Interval|Geometric Mean
2667492|NCT01514461|Secondary|Percent Change From Baseline in Fasting Triglycerides||Baseline, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.|||Percent change||95% Confidence Interval|Geometric Mean
2667493|NCT01514461|Secondary|Percentage of Patients Achieving Fasting Triglycerides (TG) Target Thresholds|Percentage of patients reaching target values of <1000 mg/dL or target values of < 2000 mg/dL for fasting triglycerides is reported. Pecentage calculated as (m/n)*100; where 'm' The number of patients who reach target values for fasting triglyceride, 'n' the number of patients with non-missing fasting triglyceride.|12 weeks, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.|||Percentage of patients|||Number
2667494|NCT01514461|Secondary|Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline|Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.|Baseline, 12 weeks, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.|||Percentage of participants|||Number
2667495|NCT01514461|Secondary|Percentage of Patients Responding to Investigational Treatment by Achieving Final Fasting Triglycerides < 8.4 mmol/L (750 mg/dL)|Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.|12 weeks, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.|||Percentage of participants|||Number
2667496|NCT01514461|Secondary|Percentage of Patients Responding to Investigational Treatment by Achieving Fasting Triglycerides (TG) of at Least 40% From Baseline or Final Fasting TG < 8.4 mmol/L (750 mg/dL)|Percentage calculated as (m/n)*100 where m = number of patients who respond; n = the number of patients with non-missing fasting triglyceride.|Baseline, 12 weeks, 24 weeks, 52 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized.|||Percentage of participants|||Number
2667497|NCT01514461|Primary|Percent Change in Fasting Triglycerides From Baseline to 12 Weeks|Blood samples were collected for a fasting lipid panel, including triglycerides. If the 12-week value was missing, the measurement value at 12 weeks or the last available post-baseline measurement value during the double-blind treatment period was analyzed. Baseline is defined as the average of fasting triglyceride values taken at day -3 and day 1. Adjusted geometric means are calculated by back-transforming the adjusted means from the model and expressing as a percentage change from baseline.|Baseline to 12 weeks|Full analysis set (FAS) consisted of all randomized patients, except for those who were mis-randomized. The number of randomized patients with non-missing fasting triglycerides values at baseline and Week 12 are included in this analysis.|||percent change||95% Confidence Interval|Geometric Mean
2667498|NCT01514448|Secondary|Duration of Response (DOR) in Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months|The duration of overall response (DOR) was defined as the time from the first occurrence of a confirmed Complete Response (CR) or Partial Response (PR) (as per investigator assessment according to RECIST 1.1) until the date of the first documented disease progression or death due to underlying cancer. If a patient did not have an event or received any further anticancer therapy, duration of overall response was censored at the date of last adequate tumor assessment. Duration of response was displayed only for patients whose best overall response was CR or PR. As none of the patients showed any response (CR or PR), DOR could not be calculated|48 months|Duration of response was displayed only for patients whose best overall response was CR or PR. As none of the patients showed any response (CR or PR), DOR could not be calculated||||||
2667499|NCT01514448|Secondary|Overall Survival (OS) of Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months|Overall survival (OS) was defined as the time from date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival will be censored at the date of last contact.|48 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus.|||months||80% Confidence Interval|Median
2667500|NCT01514448|Secondary|Progression-Free Survival (PFS) as the Time Interval Between First Intake of Everolimus and First Documented Disease Progression or Death Due to Any Cause at 24 Months|Progression-free survival (PFS) is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient did not have an event, progression-free survival was censored at the date of last adequate tumor assessment|24 months|Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus.|||months||80% Confidence Interval|Median
2668952|NCT01499810|Secondary|Change in Mean Nighttime Diastolic BP Dipping|Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value|from baseline to 6 months||||percentages||Standard Deviation|Mean
2667501|NCT01514448|Secondary|Percentage of Patients With Overall Response Rate (ORR) Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy at Month 6|Overall response rate (ORR) is the Percentage of patients with a best overall response of complete response (CR) or partial response (PR) by month 6. ORR was assessed according to RECIST 1.1 criteria. Partial response (PR) required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as reference the baseline sum of the longest diameters. Complete response (CR) required a disappearance of all target and non-target lesions.|Month 6|Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus.|||percentage of participants|||Number
2667502|NCT01514448|Primary|Percentage of Progression-free Patients by Month 6|Percentage of progression-free patients by month 6 after starting everolimus treatment. For the purpose of the binomial design of the study, a patient being 'progression-free' will be defined as a patient without disease progression by month 6 whereas a subject with progressive disease by month 6 will not be counted as 'progression-free'. The primary variable was derived from radiologic tumor assessments according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.) Disease progression was either 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline (minimum absolute increase 5 mm in sum) or 2) the appearance of a new lesion or 3) the unequivocal progression of non-target lesions overall.|Month 6|Full Analysis Set (FAS) consisted of all patients who received at least one dose of everolimus.|||Percentage of participants|||Number
2667503|NCT01514422|Secondary|Changes in Young Mania Rating Scale (YMRS)|Measured at baseline and week 8. The YMRS is an 11-item questionnaire to measure the severity of manic symptoms. 7 items are scored 0-4 and the other 4 items are scored 0-8, with overall score range from 0 (normal) to 60 (severe mania).|baseline and week 8||||units on a scale||Standard Deviation|Mean
2667504|NCT01514422|Secondary|Change in N-acetylaspartate (NAA), as Measured by 1H-MRS Scan|Measured at baseline and week 8|baseline and week 8||||mmol/L||Standard Deviation|Mean
2667505|NCT01514422|Primary|Change in Scores on the Montgomery-Asberg Depression Rating Scale (MADRS)|Measured at baseline and week 8. The MADRS-S has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).|baseline and week 8||||units on a scale||Full Range|Mean
2667506|NCT01514396|Secondary|Adverse Events Related to Wound Closure|Adverse events reported|14 days||||participants|||Number
2667507|NCT01514396|Primary|Number of Participants With Wound Closure|wound closure measured baseline to 14 days|baseline to 14 days||||participants|||Number
2667508|NCT01514383|Secondary|"Number of Participants With a Score of 0 (No Hurt) on the Pain Rating Scale"|Pain was assessed using the Wong-Baker FACES™ Pain Rating Scale, with 0 =No Hurt to 10=Hurts Worst|At Surgery|All 34 participants|||Participants|||Count of Participants
2667509|NCT01514383|Primary|Wound Length Closure|Primary incision wound length treatment in adult and pediatric general surgery|During Surgery||||milimeters||Standard Deviation|Mean
2667510|NCT01514370|Secondary|Hazard Ratio for Time to First Documented Relapse|Relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition. Hazard ratio for time to first documented relapse was planned to be reported as per SAP.|Baseline up to Date at which first Relapse Occurs assessed up to 24 months|ITT population included all randomized subjects.|||Ratio||95% Confidence Interval|Number
2667511|NCT01514370|Secondary|Number of Subjects With Premature Termination From Treatment|Number of subjects with premature termination from treatment were reported.|Baseline up to Month 24|The Intent-to-Treat (ITT) population included all randomized subjects.|||Subjects|||Number
2667512|NCT01514370|Secondary|Time on Treatment (Adherence to Treatment)|Time up to which subjects were adhered to the treatment was reported.|Baseline up to 2.2 years|The Safety population included all subjects who received at least one administration of study medication.|||Years||Full Range|Median
2667513|NCT01514370|Secondary|Number of Subjects With One Concomitant Medication From Baseline up to Month 24|Number of subjects with at least one concomitant medication from baseline up to month 24 were reported.|Baseline up to Month 24|The ITT population included all randomized subjects.|||Subjects|||Number
2667514|NCT01514370|Secondary|Number of Subjects With Clinical Significant Abnormality in Laboratory Parameters|Laboratory assessment included haematology, chemistry, and urinalysis. Clinical significance was determined by the investigator.|From screening up to Month 24|The Safety population included all subjects who received at least one administration of study medication.|||Subjects|||Number
2667515|NCT01514370|Secondary|Number of Subjects With Treatment Emergent Adverse Event (TEAE), Serious AE (SAE), TEAE Leading to Death and Discontinuation|AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 24 months. TEAEs include both Serious TEAEs and non-serious TEAEs.|Baseline up to Month 24|The Safety population included all subjects who received at least one administration of study medication.|||Subjects|||Number
2667528|NCT01514370|Secondary|Annualized Relapse Rate at Month 12 and 24|Relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition. Annualized relapse rate was calculated by dividing the total number of relapse events by the total number of days subjects participated in the study. This number was then multiplied by 365.25 to get an annualized rate.|Month 12 and 24|"ITT population included all randomized subjects. Here, Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure. Here Number analyzed signifies those subjects who were evaluable for this outcome measure at the specified timepoint."|||Relapse per year||Standard Deviation|Mean
2667516|NCT01514370|Secondary|Flu-like Symptoms (FLS) Assessed by FLS Scale Score|Flu-like symptoms were measured using FLS score in which subjects were scored as per the presence and intensity of muscle aches, chills, and weakness, each separately, on a scale of 0-3 as follows: 0 = absent; 1 = mild, do not interfere with daily activities; 2 = moderate, sufficient to interfere with daily activities; and 3 = severe, bed rest require. Body temperature also was also recorded to determine the presence of fever using the following scale: 0 (≤ 37.2 °C); 1 (≥ 37.3 °C but < 37.8 °C); 2 (≥ 37.8 but < 38.4 °C); and 3 (≥ 38.4 °C).The scores for each symptom (muscle aches, chills, weakness, body temperature) was added together to provide the combined flu-like symptom score ranging from 0 to 12 where 0 indicates absence of any symptom and 12 indicates the worst severity of the symptoms.|Screening, Baseline, Month 3, 6, 12 and 24|"The Safety population included all subjects who received at least one administration of study medication. Here Number analyzed signifies those subjects who were evaluable for this outcome measure at the specified timepoint."|||Units on a scale||Standard Deviation|Mean
2667517|NCT01514370|Secondary|Median Change From Baseline in Regional Brain Volume at Month 12 and 24|Brain tissue volumes are inter-related and represent a measure of neurodegenerative aspects of the disease.|Baseline, Month 12 and 24|As per change in Statistical Analysis Plan, data was not collected for this endpoint||||||
2667518|NCT01514370|Secondary|Median Change From Baseline in Whole Brain Volume at Month 12 and 24|Brain tissue volumes are inter-related and represent a measure of neurodegenerative aspects of the disease.|Baseline, Month 12 and 24|As per change in Statistical Analysis Plan, data was not collected for this endpoint||||||
2667519|NCT01514370|Secondary|Cumulative Number of New T1 (Hypointense) Lesions|Cumulative number of new T1 (Hypointense) lesions were reported.|Baseline up to Month 24|"The Intent-to-Treat (ITT) population included all randomized subjects. Here Number of subjects analyzed included the subjects who were evaluable for this outcome measure."|||Lesions||Standard Deviation|Mean
2667520|NCT01514370|Secondary|Mean Number of New T1 (Hypointense) Lesions at Month 12 and 24|Mean number of new T1 (Hypointense) Lesions represents a measure of accumulation of inflammatory disease burden assessed on magnetic resonance imaging (MRI) scans.|Month 12 and 24|"The ITT population included all randomized subjects. Here Number analyzed signifies those subjects who were evaluable for this outcome measure at the specified timepoint."|||Lesions||Standard Deviation|Mean
2667521|NCT01514370|Secondary|Mean Number of New Gadolinium (Gd)-Enhancing Lesions at Month 12 and 24|New Gd-enhancing Lesions are a measure of inflammatory activity and were assessed using the Magnetic Resonance Imaging (MRI) scan.|Month 12 and 24|"The ITT population included all randomized subjects. Here Number analyzed signifies those subjects who were evaluable for this outcome measure at the specified timepoint."|||Lesions||Standard Deviation|Mean
2667522|NCT01514370|Secondary|Percentage of Subjects With Combined Unique Active (CUA) Lesions at Month 12 and 24|CUA lesion was defined as new gadolinium (Gd)-enhancing lesions on T1-weighted, or new or enlarging lesions on T2-weighted MRI scans, without double counting.|Month 12 and 24|ITT population included all randomized subjects.|||Percentage of Subjects|||Number
2667523|NCT01514370|Secondary|Percentage of Subjects With Active (New/Enlarging) T2 Lesions at Month 24|A single T2 lesion was defined as an area of increased signal on a given 3-millimeters axial image that was not referable to normally hyperintense structures. New T2 lesions were those that appear in areas where on the previous scan no abnormality was detected. All T2 lesions were detected by an MRI scan.|Month 24|ITT population included all randomized subjects.|||Percentage of subjects|||Number
2667524|NCT01514370|Secondary|Hazard Ratio for Time to First Sustained Expanded Disability Status Scale (EDSS) Progression|EDSS progression is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Overall scores ranges from 0.0 (normal) to 10.0 (death due to MS). A sustained progression on EDSS score was defined as an EDSS progression confirmed into two consecutive assessment. EDSS values obtained during clinical attacks are not excluded for the assessment of EDSS progression. However, EDSS values obtained during MS attacks that are not confirmed after two consecutive assessments will be excluded from statistical analysis of confirmed EDSS progression. Hazard ratio for time to first sustained EDSS progression was planned to be reported as per SAP.|Baseline to date at which the first confirmed EDSS progression occurs, assessed up to 24 months|"ITT population included all randomized subjects. Here, Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure."|||Ratio||95% Confidence Interval|Number
2667525|NCT01514370|Secondary|Percentage of Subjects Free From Expanded Disability Status Scale (EDSS) Progression at Month 12 and 24|Disability progression was assessed using EDSS. EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in multiple sclerosis (MS) . Overall scores ranges from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as an increase of EDSS score of at least 1.0 point compared to baseline for subjects with an EDSS =< 4.0. For subjects with an EDSS= 0 at baseline, EDSS progression was defined as an increase of EDSS score of at least 1.5 point. Percentage of subjects free from EDSS progression at Month 12 and 24 were reported|Month 12 and 24|ITT population included all randomized subjects.|||Percentage of subjects|||Number
2667526|NCT01514370|Secondary|Percentage of Subjects Treated With Glucocorticoids Due to Relapses During 24 Months|Relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition. Percentage of subjects treated with glucocorticoids due to relapses during 24 Months were reported here.|Baseline up to Month 24|ITT population included all randomized subjects.|||Percentage of Subjects|||Number
2667527|NCT01514370|Secondary|Total Number of Reported Relapses at Month 3, 6, 12 and 24|Relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.|Month 3, 6, 12 and 24|"The ITT population included all randomized subjects. Here, Number of subjects analyzed signifies those subjects who were evaluable for this outcome measure. Here Number analyzed signifies those subjects who were evaluable for this outcome measure at the specified timepoint."|||Relapses||Standard Deviation|Mean
2667775|NCT01512160|Secondary|Supine Pulse Rate|Supine pulse rate was measured in the brachial/radial artery for at least 30 seconds.|Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time point.|||beats per minute||Standard Deviation|Mean
2667529|NCT01514370|Secondary|Percentage of Relapse-Free Subjects at Month 12 and Month 24|Relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.|Month 12 and 24|ITT population included all randomized subjects.|||Percentage of subjects|||Number
2667530|NCT01514370|Primary|Number of Subjects With Active (New or Enlarging) T2 Lesions Assessed by Magnetic Resonance Imaging (MRI) at Month 12|A single T2 lesion was defined as an area of increased signal on a given 3-millimeters axial image that was not referable to normally hyperintense structures. New T2 lesions were those that appear in areas where on the previous scan no abnormality was detected. All T2 lesions were detected by an MRI scan.|Month 12|ITT population included all randomized subjects.|||Participants|||Count of Participants
2667531|NCT01514357|Primary|Changes in Systolic Blood Pressure (BP)|The change in BP with treatment over 7 days was assessed by the mean BP on admission, (treatment day 1) mean BP 23 hours after the first injection of BNP, and mean BP 23 hours after the second injection of BNP (treatment day 2). Treatment day 2 was 7 days after admission.|baseline, treatment day 1, treatment day 2||||mmHg||Standard Deviation|Mean
2667532|NCT01514318|Secondary|Harris Hip Score|A tool for the evaluation of how a patient is doing after their hip is replaced. Based on a total of 100 points possible, each question is awarded a certain number of points based on how it is answered. Questions are further grouped into four categories. The first category is pain, the second category is function, third is functional activities and finally the physical exam results are tabulated, and based on your range of motion. The score is reported as 90-100 for excellent results, 80-90 being good, 70-79 fair, 60-69 poor, and below 60 a failed result.|10 year||||units on a scale||Standard Deviation|Mean
2667533|NCT01514318|Secondary|Western Ontario McMaster Arthritis Index (WOMAC)|Standardized questionnaire used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip. It assesses the pain, joint stiffness, physical, social & emotional function of a person with osteoarthritis in determining the overall level of disability. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). For each item, the possible range of scores is therefore 0-100. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. Physical functioning questions cover everyday activities such as stair use, standing up from a sitting or lying position, standing, bending, walking, getting in and out of a car, shopping, putting on or taking off socks, lying in bed, getting in or out of a bath, sitting, and heavy and light household duties.|10 year||||units on a scale||Standard Deviation|Mean
2667534|NCT01514318|Primary|Survivorship of the Device|The subject meets the inclusion/exclusion criteria of the study and received a Revelation Hip Stem prior to 2002 that has survived intact without any type of surgery to revise or remove parts or the whole prosthesis.|10 year|Subjects who signed the consent form and completed the study paperwork.|||participants|||Number
2667535|NCT01514292|Primary|CGM Relative Differences to Laboratory Reference|The outcome measure is measured as the relative differences (%) of the CGM glucose value in reference to a laboratory reference, yellow spring instrument( YSI) glucose measurements.|7 days||||Percentage of difference||Standard Deviation|Mean
2667536|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 10 - Social Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667537|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 8 - Social Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667538|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 4 - Social Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667618|NCT01513551|Secondary|Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibodies|OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay (MOPA-4)|One month postvaccination|The analysis population consisted of those participants who were not considered to have violated important protocol requirements that could have impacted the validity of the antibody response measured following vaccination.|||Titer||95% Confidence Interval|Geometric Mean
2667539|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 2 - Social Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667540|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 10 - Emotional Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667541|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 8 - Emotional Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667542|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 4 - Emotional Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667543|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 2 - Emotional Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667544|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 10 - Systemic Symptom|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667545|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 8 - Systemic Symptom|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667546|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 4 - Systemic Symptom|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667547|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 2 - Systemic Symptom|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667548|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 10 - Bowel Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667549|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 8 - Bowel Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667550|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 4 - Bowel Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667551|NCT01514240|Secondary|Change in IBDQ Scores From Baseline to Weeks 2 - Bowel Function|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667552|NCT01514240|Secondary|Change in Total IBDQ Scores From Baseline to Weeks 10|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|10 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 10 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667553|NCT01514240|Secondary|Change in Total IBDQ Scores From Baseline to Weeks 8|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667554|NCT01514240|Secondary|Change in Total IBDQ Scores From Baseline to Weeks 4|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667555|NCT01514240|Secondary|Change in Total IBDQ Scores From Baseline to Weeks 2|The Inflammatory Bowel Disease Questionnaire (IBDQ) is a standard measure of HRQL in Crohn's disease patients (Guyatt G et al 1989). The validated Japanese version of the IBDQ was used in this study (Hashimoto H et al 2003). The IBDQ contains 32 questions; each with seven possible answers ranging from 1 to 7, where 7 is the most favourable. Ten questions are related to bowel symptoms, five to systemic symptoms, twelve to emotional function, and five to social function. The corresponding answers will be added to form four subscores and a total score: bowel function score (10 - 70), systemic symptom score (5 - 35), emotional function score (12 - 84), social function score (5 - 35) and the total score (32 - 224), with higher scores indicating more favorable outcome.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667556|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 8|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.|||Participants|||Number
2667557|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 4|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.|||Participants|||Number
2667558|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 100 Points) at Weeks 2|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 100 points.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.|||Participants|||Number
2667559|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 8|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.|||Participants|||Number
2667560|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 4|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.|||Participants|||Number
2667561|NCT01514240|Secondary|Clinical Improvement Rates (Decrease in CDAI Score From Baseline of at Least 70 Points) at Weeks 2|Clinical improvement is defined as CDAI score of <=150 or a decrease in CDAI score from baseline of at least 70 points.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period.|||Participants|||Number
2667562|NCT01514240|Secondary|Cumulative Remission Rate at Week 8|Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 8 is obtained by Kaplan-Meier (KM) estimates.|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period|||Percentage of participants||90% Confidence Interval|Number
2667563|NCT01514240|Secondary|Cumulative Remission Rate at Week 4|Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 4 is obtained by Kaplan-Meier (KM) estimates.|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period|||Percentage of participants||90% Confidence Interval|Number
2667564|NCT01514240|Secondary|Cumulative Remission Rate at Week 2|Remission rate is defined as CDAI score of less than or equal to 150. Cumulative remission rate at Week 2 is obtained by Kaplan-Meier (KM) estimates.|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period|||Percentage of participants||90% Confidence Interval|Number
2667574|NCT01514201|Other Pre-specified|Levels of Urinary Biomarkers|Urine samples were analyzed for a panel of biomarkers. Netrin-1 levels were determined by ELISA. Levels of matrix metalloproteinase 3 (MMP3) and basic fibroblast growth factor (bFGF) were analyzed using custom Luminex® screening assays. Tissue inhibitor of metalloproteinase 1 (TIMP1) levels were analyzed using a Luminex® performance assay. Protein concentrations are given in picograms per microgram (pg/μg), and were determined by dividing the concentration of the target protein in the sample (pg/mL) by the concentration of total protein in the sample (μg/mL) as a normalization measure.|Baseline to up to 3 years|Not all patients had urine samples at each time point.|||pg/μg||Full Range|Median
2667565|NCT01514240|Secondary|Change in Observed CDAI Scores From Baseline to Weeks 8|"Crohn's Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn's disease. Total CDAI score 150 less or equal is evaluated as a remission.~Patients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit."|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 8 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667566|NCT01514240|Secondary|Change in Observed CDAI Scores From Baseline to Weeks 4|"Crohn's Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn's disease. Total CDAI score 150 less or equal is evaluated as a remission.~Patients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit."|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 4 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667567|NCT01514240|Secondary|Change in Observed CDAI Scores From Baseline to Weeks 2|"Crohn's Disease Activity Index (CDAI) score is calculated based on the data collected in the diary card. The total CDAI score ranges from 0 to approximately 600, a higher scores indicating more severe disease. The target population of total CDAI score 180 to 400 is defined mild to modarate active Crohn's disease. Total CDAI score 150 less or equal is evaluated as a remission.~Patients are asked to fill the following items in the diary card (from the morning in preceding day to the morning in current day). (1) Number of liquid or very soft stools (2) Abdominal pain rating (none, mild, moderate, severe) (3) General well-being (generally well, slightly under par, poor, very poor, terrible) (4) Body temperature (if a patient feels fever) (5) Intake of loperamide or other opiates for diarrhoea. The data for the calculation of CDAI score in diary card is then transcribed by the investigator(s) into the eCRFs at each clinical visit."|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period. However, the patients with both baseline and week 2 data were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2667568|NCT01514240|Secondary|Remission After 4-week of Treatment|"For the secondary efficacy variable Remission after 4 weeks of treatment, Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150."|4 Week|All randomised patients who take the investigational products at least once and have data in the treatment period|||Participants|||Number
2667569|NCT01514240|Secondary|Remission After 2-week of Treatment|"For the secondary efficacy variable Remission after 2 weeks of treatment, Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150."|2 Week|All randomised patients who take the investigational products at least once and have data in the treatment period|||Participants|||Number
2667570|NCT01514240|Primary|Remission After 8-week of Treatment|"For the primary efficacy variable Remission after 8 weeks of treatment, Crohn's Disease Activity Index CDAI scores was used to determine the patient's response. Remission for this study is defined as a CDAI score of ≤150. A patient who drops out without any remission before week 8 was considered as a nonresponder (no remission) for this analysis. A patient who drops out before Week 8, but was in remission at the time of dropout, was considered in remission after dropout in this analysis."|8 Week|All randomised patients who take the investigational products at least once and have data in the treatment period|||Participants|||Number
2667571|NCT01514201|Secondary|Trough for Veliparib [Pharmacokinetic Parameter]|During course 1, blood samples were collected pre-veliparib on day 1, at 0.5, 1, 2, and 6-8 hours after the first dose, pre-veliparib on day 4 (steady state), and 2 hours after the morning dose. Veliparib concentrations were measured using a liquid chromatography tandem mass spectrometry assay and pharmacokinetic parameters were evaluated using a non-compartmental analysis.|Up to day 4|Pharmacokinetic studies were optional for the phase II portion of the study. 6/6 phase I dose level 1 patients, 5/6 phase I dose level 2 patients, 4/6 phase I dose level 3 patients, and 20/47 phase II patients had this data available.|||ng/mL||Standard Deviation|Mean
2667572|NCT01514201|Secondary|Terminal Half-life (t1/2) for Veliparib [Pharmacokinetic Parameter]|During course 1, blood samples were collected pre-veliparib on day 1, at 0.5, 1, 2, and 6-8 hours after the first dose, pre-veliparib on day 4 (steady state), and 2 hours after the morning dose. Veliparib concentrations were measured using a liquid chromatography tandem mass spectrometry assay and pharmacokinetic parameters were evaluated using a non-compartmental analysis.|Up to day 4|Pharmacokinetic studies were optional for the phase II portion of the study. 6/6 phase I dose level 1 patients, 6/6 phase I dose level 2 patients, 4/6 phase I dose level 3 patients, and 25/47 phase II patients had this data available.|||Hour||Standard Deviation|Mean
2667573|NCT01514201|Secondary|Apparent Volume of Distribution (Vd/F) for Veliparib [Pharmacokinetic Parameter]|During course 1, blood samples were collected pre-veliparib on day 1, at 0.5, 1, 2, and 6-8 hours after the first dose, pre-veliparib on day 4 (steady state), and 2 hours after the morning dose. Veliparib concentrations were measured using a liquid chromatography tandem mass spectrometry assay and pharmacokinetic parameters were evaluated using a non-compartmental analysis.|Up to day 4|Pharmacokinetic studies were optional for the phase II portion of the study. 6/6 phase I dose level 1 patients, 6/6 phase I dose level 2 patients, 4/6 phase I dose level 3 patients, and 25/47 phase II patients had this data available.|||L/m^2||Standard Deviation|Mean
2667575|NCT01514201|Other Pre-specified|Change in Level of Gamma-H2A Histone Family, Member X (H2AX) Measured in PBMCs|Levels of gamma-H2A histone family, member X (H2AX) were to be calculated. Cox models to explore associations between the levels of gamma-H2AX and outcome (progression-free survival and overall survival) were planned, in addition to looking at associations between Poly(ADP-ribose) polymerase (PARP) activity and gamma-H2AX levels.|Baseline to up to 3 years|These data were not available as the lab did not perform these analyses. There are no plans to perform these analyses.||||||
2667576|NCT01514201|Other Pre-specified|Change in Non-homologous End-joining (NHEJ) Activity as Measured in Peripheral Blood Monocytes (PBMCs)|Levels of non-homologous end-joining (NHEJ) activity were to be calculated. Cox models to explore associations between the levels of NHEJ and outcome (progression-free survival and overall survival) were planned, in addition to looking at associations between Poly(ADP-ribose) polymerase (PARP) activity and NHEJ levels.|Baseline to up to 3 years|These data were not available as the lab did not perform these analyses. There are no plans to perform these analyses.||||||
2667577|NCT01514201|Other Pre-specified|Percentage of Participants With Significant Changes in Poly(ADP-ribose) Polymerase (PARP) Levels Post-Veliparib, as Measured in Peripheral Blood Monocytes (PBMCs)|Blood samples were collected from patients and assessed pre- and post-Veliparib to assess treatment-induced changes. A significant change in PBMC PARP level was arbitrarily defined as a >50% increase or decrease from the pre-treatment level, documented at week 6 and/or week 11 after starting protocol therapy.|Baseline and up to 11 weeks|Only 27 patients had pre- and post-Veliparib samples available in order to assess treatment-related changes. Two of the patients had inconsistent changes in post-Veliparib PARP levels and therefore were excluded from the analysis, leaving 25 patients for this objective.|||percentage of participants||95% Confidence Interval|Number
2667578|NCT01514201|Secondary|Maximum Concentration of Veliparib (Cmax) on Day 1 (Measured in μM) [Pharmacokinetic Parameter]|During course 1, blood samples were collected pre-veliparib on day 1, at 0.5, 1, 2, and 6-8 hours after the first dose, pre-veliparib on day 4 (steady state), and 2 hours after the morning dose. Veliparib concentrations were measured using a liquid chromatography tandem mass spectrometry assay and pharmacokinetic parameters were evaluated using a non-compartmental analysis. Cmax measures the highest concentration of drug.|Day 1|Pharmacokinetic studies were optional for the phase II portion of the study. Pharmacokinetic data were not available for all patients. 6/6 phase I dose level 1, 6/6 phase I dose level 2, 4/6 phase I dose level 3, and 25/47 phase II patients had day 4 Cmax data available.|||μM||Standard Deviation|Mean
2667579|NCT01514201|Secondary|Mean Apparent Clearance (CL/F) for Veliparib [Pharmacokinetic Parameter]|During course 1, blood samples were collected pre-veliparib on day 1, at 0.5, 1, 2, and 6-8 hours after the first dose, pre-veliparib on day 4 (steady state), and 2 hours after the morning dose. Veliparib concentrations were measured using a liquid chromatography tandem mass spectrometry assay and pharmacokinetic parameters were evaluated using a non-compartmental analysis.|Up to day 4|Pharmacokinetic studies were optional for the phase II portion of the study. 6/6 phase I dose level 1 patients, 6/6 phase I dose level 2 patients, 4/6 phase I dose level 3 patients, and 25/47 phase II patients had this data available.|||L/m^2/h||Standard Deviation|Mean
2667580|NCT01514201|Secondary|Maximum Concentration of Veliparib (Cmax) on Days 1 and 4 (Measured in ng/mL) [Pharmacokinetic Parameter]|During course 1, blood samples were collected pre-veliparib on day 1, at 0.5, 1, 2, and 6-8 hours after the first dose, pre-veliparib on day 4 (steady state), and 2 hours after the morning dose. Veliparib concentrations were measured using a liquid chromatography tandem mass spectrometry assay and pharmacokinetic parameters were evaluated using a non-compartmental analysis. Cmax measures the highest concentration of drug.|Up to day 4|Pharmacokinetic studies were optional for the phase II portion of the study. Pharmacokinetic data were not available for all patients as indicated in the outcome measure data table below.|||ng/mL||Standard Deviation|Mean
2667581|NCT01514201|Secondary|Percentage of Patients With Pseudo Progression|For participants that showed possible tumor progression (pseudo progression) on magnetic resonance imaging (MRI) during the first 6 months of therapy, treating physicians had the option of allowing patients to remain on therapy and repeating the disease assessment in 4-6 weeks. If the repeat MRI at 4-6 weeks showed disease progression, the patient was noted to have true disease progression (and the progression date corresponded to that of the first MRI). If the repeat MRI at 4-6 weeks did not show disease progression, then the patient was noted to have pseudo progression. The percentage of patients observed to have experienced pseudo progression was provided with a 95% confidence interval.|Up to 6 months||||Percentage of participants||95% Confidence Interval|Number
2667582|NCT01514201|Secondary|Progression-free Survival (PFS)|PFS was defined as the interval from date of treatment initiation to date of first event (disease progression or relapse, second malignancy or death from any cause). Patients who had not failed at the time of analyses were censored at their last date of contact. The method of Kaplan and Meier was used to estimate PFS. A 3-year estimate with a 95% confidence interval is reported.|Time from initiation of treatment to the earliest date of failure (disease progression, death from any cause, or second malignancy), assessed up to 3 years|53 patients were evaluable for outcome analyses (47 phase II patients + 6 phase I patients treated at the MTD). 50 patients were evaluable; 1 patient withdrew prior to beginning protocol therapy and 2 patients did not receive adequate study drug to be evaluable for efficacy. To be evaluable patients had to receive at least one dose of Veliparib.|||Percent probability||95% Confidence Interval|Number
2667583|NCT01514201|Primary|Number of Phase I Patients Who Experienced Dose Limiting Toxicities (DLTs)|DLTs were defined as any of the following adverse events that were at least possibly attributable to Veliparib observed during the dose finding phase (the first 10 weeks of therapy). Hematologic dose limiting toxicities included grade 3 and higher thrombocytopenia or grade 4 neutropenia. Non-hematologic dose limiting toxicities included any grade 4 non-hematologic toxicity, any grade 3 non-hematologic toxicity with some exceptions (e.g., nausea and vomiting of <5 days; fever or infection of <5 days; hypophosphatemia, hypokalemia, hypocalcemia or hypomagnesemia responsive to oral supplementation; elevation of transaminases that return to levels meeting eligibility criteria within 7 days), or any grade non-hematologic toxicity that persisted for >7 days and considered medically significant or sufficiently intolerable by patients that required treatment interruption.|10 weeks||||Participants|||Count of Participants
2668953|NCT01499810|Secondary|Change in Mean Nighttime Systolic BP Dipping|Mean nighttime BP dipping is a relative difference: absolute difference between mean daytime and mean nighttime BP values divided by mean daytime BP value|from baseline to 6 months||||percentages||Standard Deviation|Mean
2667584|NCT01514201|Primary|Overall Survival|Overall survival was defined as the interval from date on treatment to date of death from any cause or to date of last follow-up. Patients who had not failed (died) at the time of analyses were censored at their last date of contact. The method of Kaplan and Meier was used to estimate overall survival. The 3-year estimate with a 95% confidence interval is reported.|Time from initiation of therapy to the date of death from any cause or to the date patient was known to be alive for surviving patients, assessed to up to 3 years|53 patients were evaluable for outcome analyses (47 phase II patients + 6 phase I patients treated at the MTD). 50 patients were evaluable; 1 patient withdrew prior to beginning protocol therapy and 2 patients did not receive adequate study drug to be evaluable for efficacy. To be evaluable patients had to receive at least one dose of Veliparib.|||Percent probability||95% Confidence Interval|Number
2667585|NCT01514201|Primary|Percentage of Participants Observed to Have Unacceptable Toxicity During the Intra-patient Dose Escalation of Temozolomide During Maintenance Therapy (Feasibility Analysis Population)|Unacceptable toxicities during maintenance included events at least possibly attributable to Veliparib and temozolomide (TMZ) such as any grade 4 non-hematologic toxicity, any grade 3 non-hematologic toxicity with some exceptions (e.g., grade 3 nausea/vomiting <5 days, grade 3 fever or infection <5 days), grade 3+ thrombocytopenia, grade 4 neutropenia, delay >14 days in starting subsequent cycle due to neutrophil <1,000/mm3 or platelet <100,000/mm3. Maintenance therapy was initiated with 25 mg/m2 Veliparib and 135 mg/m2 of TMZ, with the possibility to escalate TMZ to 175 mg/m2 and 200 mg/m2 in courses 2 and 3, respectively, if no unacceptable toxicities occurred following one course of treatment at each of the dose levels to be tested. Intra-patient dose escalation to a given dose (135, 175, or 200 mg/m2) was halted based on rules employed in 3+3 designs. This dose escalation was intended for all patients but was halted early, during the phase I portion, as it was not well tolerated.|28 days per treatment cycle|Patients were combined across dose levels since they received the same maintenance therapy. Though this objective was intended for all patients, only the first 12 enrolled were included as the dose-escalation stopped early. 1 of the first 12 patients did not start maintenance due to early progression, so 11 patients started dose level 1.|||% of participants|||Number
2667586|NCT01514201|Primary|Maximum-tolerated Dose of Veliparib Defined as Highest Dose Level With Fewer Than 2 Dose Limiting Toxicities in 6 Patients as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I)|The traditional 3+3 dose finding algorithm was used to estimate the maximum-tolerated dose of veliparib given concurrently with radiation therapy. The dose-limiting toxicity observation period was the first 10 weeks of therapy. Dose-limiting toxicities included any grade 4 non-hematologic toxicity, any grade 3 non-hematologic toxicity with a few exceptions (see section 5.2.1.2 of the protocol document), any grade 2 non-hematologic toxicity that persisted for >7 days and considered medically significant that required treatment interruption; grade 3 or higher thrombocytopenia or grade 4 neutropenia; and any Veliparib related adverse event that led to a dose reduction or the permanent cessation of therapy.|10 weeks|The first 18 patients enrolled on the study were phase I patients used to determine the maximum tolerated dose or the recommended phase II dose and to address other objectives of the phase I component of this trial.|||mg/m2/dose BID|||Number
2667587|NCT01514162|Secondary|Report the Hemodynamic Performance of the Valve|"Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg.~Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve.~Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size."|5 years|Aortic valve mean gradient at 5 years for participants analyzed with a visit and completed assessment|||mmHg||Standard Deviation|Mean
2667588|NCT01514162|Secondary|Characterize Patient NYHA Functional Classification Status|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. Patients with cardiac disease but without resulting limitation of physical activity.~Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.~Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.~Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.~The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256."|5 years|Number of participants analyzed is those subjects with a visit and completed assessment|||participants|||Number
2667589|NCT01514162|Primary|Late Adverse Event Incidence|"Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events.~Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]"|5 years||||event/100-patient years|||Number
2667590|NCT01514149|Secondary|Time to Hyperglycemia Rescue||18 weeks|Completed Population|||days||Standard Deviation|Mean
2667591|NCT01514149|Secondary|Fasting Body Weight CFB to Week 18||CFB to Week 18|Completed Population|||kg||Standard Deviation|Mean
2667592|NCT01514149|Primary|Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18||CFB to Week 18|Completed Population|||Percent (%)||Standard Deviation|Mean
2667593|NCT01514136|Primary|Degree of Leakage|"The degree of leakage under the baseplate was measured on a 24-point scale where 0 point was the best possible outcome with no leakage under the baseplate and 24-point was the worst possible outcome with leakage under the whole plate.~The scale was developed by Coloplast A/S"|One week||||units on a scale|Participants|Standard Deviation|Mean
2667594|NCT01513967|Primary|The Primary Objective: to Evaluate the Safety and Tolerability of RPh201 After Single and Multiple Rising Doses.|Safety and tolerability following single and multiple ascending SC injection doses as assessed by Treatment-Emergent Adverse Events|up to 1 month|"The study analysis populations included the following:~Randomized Population: All subjects who were assigned a randomization number in the Treatment Phase.~Safety Population: All randomized subjects who received any study treatment in the Treatment Phase."|||Participants|||Count of Participants
2668244|NCT01507831|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.|||percent change||Standard Error|Least Squares Mean
2667595|NCT01513902|Secondary|Taste Assessment|Participants were evaluated for taste assessment using a 5 categories questionnaire. Participants were asked to answer one of the following to describe the taste of oral solution of tofacitinib: Dislike very much, dislike a little, not sure, like a little, or like very much. The taste assessment was only performed for participants who received the oral solution. Number of participants within each category are reported.|Day 1, Day 5|The analysis population was defined as all participants who had received at least 1 oral solution formulation of tofacitinib.|||participants|||Number
2667596|NCT01513902|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were analyzed for this outcome measure.|||hours||Standard Deviation|Mean
2667597|NCT01513902|Secondary|Apparent Volume of Distribution (Vz/F)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.|Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were analyzed for this outcome measure.|||liter||Geometric Coefficient of Variation|Geometric Mean
2667598|NCT01513902|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest.|||hours||Full Range|Median
2667599|NCT01513902|Secondary|Maximum Observed Plasma Concentration (Cmax)||Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2667600|NCT01513902|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)||Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were analyzed for this outcome measure.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2667601|NCT01513902|Primary|Number of Participants With Clinically Significant Vital Signs Abnormalities|Criteria for vital signs of potentially clinical concern included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, standing pulse rate of <40 bpm or >140 bpm, systolic blood pressure of >=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure <90 mmHg, diastolic blood pressure >=20 mmHg change from baseline and diastolic blood pressure <50 mm Hg.|Baseline up to Day 5|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
2667602|NCT01513902|Primary|Number of Participants With Laboratory Test Abnormalities|Participants with laboratory test abnormalities of potential clinical concern without regard to baseline abnormality were reported. Criteria: Hematology(hemoglobin,hematocrit,red blood cell[RBC] count:<0.8*lower limit of normal [LLN], platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal[ULN], white blood cell [WBC] count:<0.6*LLN></0>1.5*ULN, lymphocytes, total neutrophils:<0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes:>1.2*ULN); Liver Function (total bilirubin: >1.5*ULN, aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>3.0*ULN, total protein, albumin:<0.8*LLN or >1.2*ULN);Renal Function (blood urea nitrogen, creatinine:>1.3*ULN, uric acid:>1.2*ULN); Electrolytes (sodium:<0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN);Clinical chemistry (glucose <0.6*LLN or >1.5*ULN, creatine kinase:>3.0*ULN); Urinalysis (Urine WBC and RBC: greater than or equal to [>=] 6/High Power Field [HPF]).|Baseline up to Day 5|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
2667603|NCT01513902|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) All Causalities|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs included both serious and non-serious AEs.|Baseline up to 28 days after the last dose of study drug (Day 5)|The safety analysis population included all participants who received at least 1 dose of study drug.|||participants|||Number
2667604|NCT01513902|Primary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is also influenced by the fraction of the dose absorbed. Clearance was estimated by non compartmental analysis (NCA) of PK data. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. It was calculated by dividing the given oral dose by AUCtau. AUCtau is the area under the plasma concentration time-curve from time zero to end of dosing interval.|Day 5: Pre-dose, 0.5, 1, 2, 4, 8 hours post dose|The PK analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest. Here 'number of participants analyzed (N)' signifies those participants who were evaluable for this outcome measure.|||liter per hour||Geometric Coefficient of Variation|Geometric Mean
2667605|NCT01513759|Secondary|Number of Devices That Could Not be Successfully Used for Infusion|Technical complications associated with the use of the EkoSonic device was recorded during catheter placement in the pulmonary artery and during the infusion procedure.|Baseline up to Day 30|Safety analysis set included all participants who started the EkoSonic device placement procedure.|||devices|devices||Count of Units
2667606|NCT01513759|Secondary|Number of Participants Who Died Due to Any Cause|Number of participants who died due to any cause for up to 30 days following the conclusion of the ultrasound-accelerated catheter-directed fibrinolysis procedure, were reported.|Baseline up to Day 30|Efficacy analysis set included all participants who started the ultrasound accelerated thrombolysis therapy. One participant was excluded from this analysis due to lost to follow-up after discharge.|||Participants|||Count of Participants
2668954|NCT01499810|Secondary|Change in Mean Nighttime Diastolic BP||from baseline to 12 months||||mmHg||Standard Deviation|Mean
2667607|NCT01513759|Secondary|Percentage of Participants With Symptomatic Recurrent Pulmonary Embolism (PE)|Percentage of participants with symptomatic recurrent PE up to 30 days following the conclusion of the ultrasound-accelerated catheter-directed fibrinolysis procedure, were reported with a Wilson score 95% confidence interval. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline up to Day 30|Efficacy analysis set included all participants who started the ultrasound accelerated thrombolysis therapy. One participant was excluded from this analysis due to lost to follow-up after discharge.|||percentage of participants||95% Confidence Interval|Number
2667608|NCT01513759|Secondary|Change From Baseline in Pulmonary Artery Systolic Pressure at 48 Hours After Start of Therapy|Change in pulmonary artery systolic pressure was assessed by baseline right-heart catheterization compared with right-heart catheterization at the conclusion of ultrasound-accelerated catheter-directed fibrinolysis and estimated by post-procedure transthoracic echocardiography within 48 hours after initiating the procedure.|Baseline, Hour 48 after initiation of therapy|Efficacy analysis set included all participants who started the ultrasound accelerated thrombolysis therapy. Here, 'Number analyzed' signifies participants with available data at specified timepoint.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2667609|NCT01513759|Primary|Number of Participants With Major Bleeding|Bleeding adverse events were graded (severe or life-threatening, moderate or mild bleeding) according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification. The participant incidence of major bleeding events was defined as GUSTO moderate and severe events occurring within 72 hours after starting the ultrasound-accelerated catheter-directed fibrinolysis procedure. Mild: Does not meet criteria for moderate or severe; Moderate: Requires transfusion - No hemodynamic compromise; and Severe: Bleeding causes hemodynamic compromise and required intervention or intracranial hemorrhage. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|From start of study drug infusion up to 72 hours|Safety analysis set included all participants who started the EkoSonic device placement procedure.|||Participants|||Count of Participants
2667610|NCT01513759|Primary|Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy|Change from baseline in RV diameter/LV diameter ratio was determined by contrast-enhanced chest computed tomography (CT) within 48 +/- 6 hours after initiating ultrasound-accelerated catheter-directed fibrinolysis.|Baseline, within 48 +/- 6 hours of initiation of therapy|Efficacy analysis set included all participants who started the ultrasound accelerated thrombolysis therapy. Here, 'Overall number of participants analyzed' signifies participants with available data at both baseline and post-baseline. 'Number analyzed' signifies participants with available data at specified timepoint.|||ratio||Standard Deviation|Mean
2667611|NCT01513590|Secondary|Number of Treatment Emergent AEs (Adverse Events)|A Treatment Emergent Adverse Event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. Severity was assessed by investigator.|Onset on or after the first day of exposure to investigational product and no later than 7 days after exposure to investigational product|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||events|||Number
2667612|NCT01513590|Secondary|Responder for HbA1c (Below 7.0%) Without Severe and Minor Treatment Emergent Hypoglycaemic Episodes During the Last 12 Weeks of Treatment Including Only Subjects Exposed for at Least 12 Weeks|Responder for HbA1c (<7.0%) without severe and minor treatment emergent hypoglycaemic episodes during the last 12 weeks of treatment. Severe + minor hypoglycaemic episodes = confirmed hypoglycaemic episodes. Severe hypoglycaemic episodes: requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF. Data for 15 subjects were excluded, as only subjects exposed for at least 12 weeks were included in this measurement.|||participants|||Number
2667613|NCT01513590|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight after 26 weeks of treatment.|Week 0, week 26|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. Missing data were imputed using last observation carried forward (LOCF).|||kg||Standard Deviation|Mean
2667614|NCT01513590|Secondary|Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes|The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||episodes|||Number
2667615|NCT01513590|Secondary|Number of Treatment Emergent Nocturnal (00:01-05:59 am) Severe or Minor Hypoglycaemic Episodes|The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes, which is presented here. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 am.|Onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||episodes|||Number
2667616|NCT01513590|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Change from baseline in fasting plasma glucose (FPG) after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using LOCF. At baseline 195 subjects each in IDegAsp BID and BIAsp 30 BID treatment group were analysed.|||mmol/L||Standard Deviation|Mean
2667617|NCT01513590|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects. Missing data were imputed using last observation carried forward (LOCF).|||Percent (%) glycosylated haemoglobin||Standard Deviation|Mean
2667619|NCT01513551|Primary|Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) Antibodies|Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence (ECL) assay.|One month postvaccination|The analysis population consisted of those participants who were not considered to have violated important protocol requirements that could have impacted the validity of the antibody response measured following vaccination.|||µg/mL||95% Confidence Interval|Geometric Mean
2667620|NCT01513551|Primary|Percentage of Participants With a Vaccine-related Serious Adverse Event|A SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs deemed by the investigator to be possibly, probably, or definitely related to study vaccine were reported.|Up to 6 months postvaccination|The analysis population consisted of those participants who received study vaccination and had safety follow-up.|||Percentage of Participants|||Number
2667621|NCT01513551|Primary|Percentage of Participants With a Serious Adverse Event|A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.|Up to 6 months postvaccination|The analysis population consisted of those participants who received study vaccination and had safety follow-up.|||Percentage of Participants|||Number
2667622|NCT01513551|Primary|Percentage of Participants With a Systemic Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups|Systemic AEs reported by >=2% of participants in one or more vaccination groups were assessed.|Up to Day 14 postvaccination|The analysis population consisted of those participants who received study vaccination and had safety follow-up.|||Percentage of Participants|||Number
2667623|NCT01513551|Primary|Percentage of Participants With an Injection-site Adverse Event Reported With >=2% Incidence in One or More Vaccination Groups|Injection-site AEs reported by >=2% of participants in one or more vaccination groups were assessed.|Up to Day 14 postvaccination|The analysis population consisted of those participants who received study vaccination and had safety follow-up.|||Percentage of Participants|||Number
2667624|NCT01513551|Primary|Percentage of Participants With an Adverse Event|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse experience.|All AEs: up to 14 days after vaccination; Serious Adverse Events (SAEs): up to 6 months after vaccination|The analysis population consisted of those participants who received study vaccination and had safety follow-up.|||Percentage of Participants|||Number
2667625|NCT01513538|Primary|Acceptance of TherapyGuide Proposals and Typology of Programming Changes|"The primary objective is to assess the acceptance of the TherapyGuide proposals by the physicians.~Acceptance will be assessed by measuring the proportion of cases where physicians programmed the set of parameters recommended by the TherapyGuide with no modifications."|30 months||||percentage of patients|||Number
2667626|NCT01513473|Secondary|Insulin Antibodies (Insulin Degludec Specific, Insulin Detemir Specific, Insulin Aspart Specific and Antibodies Cross-reacting to Human Insulin)|Antibody measurements : the values presented are week 52 (LOCF). The measurement of insulin antibodies after 26 and 52 weeks of treatment was done to fulfil the requirement of monitoring the long term immunogenicity. The unit of measure is percentage bound/total (%B/T) for these antibodies. The Antibodies cross reacting to Human Insulin is abbreviated as X-reacting AB Hu Insulin below)|After 52 weeks of treatment|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.|||%B/T||Standard Deviation|Mean
2667627|NCT01513473|Secondary|Steady-state Plasma Concentrations of Insulin Degludec and Insulin Detemir on Three Different Visits (Three Different Weeks) During the First 26 Weeks of Treatment|Steady state plasma concentrations of insulin degludec and insulin detemir on three different visits (three different weeks) during the trial.|Between week 1 and week 26|Full Analysis Set (FAS) Included all randomised subjects. 1 subject was excluded from the analysis in the IDet arm as he was withdrawn before exposure to trial drug.|||pmol/L||Standard Deviation|Mean
2667628|NCT01513473|Secondary|Number of Episodes With Self Monitored Blood Ketones Above 1.5 mmol (Capillary Blood Ketone Measurement to be Performed if Self-measured Plasma Glucose (SMPG) Exceeds 14.0 mmol/l (250 mg/dL))|Blood ketones > 1.5mmol/L (Capillary blood ketone measurement to be performed if SMPG exceeds 14.0mmol/L (250mg/dL) )after 26 and 52 weeks of treatment|After 26 weeks and 52 weeks of treatment|Full Analysis Set (FAS) Included all randomised subjects|||episodes|||Number
2667629|NCT01513473|Secondary|Number of Self-measured Hyperglycaemia (Episodes of PG Above 11.1 mmol/L (200 mg/dL))|Episodes of PG >11.1mmol/L (200mg/dL)|After 26 weeks and 52 weeks of treatment|Safety analysis set included all subjects receiving at least one dose of investigational product.|||episodes|||Number
2667630|NCT01513473|Secondary|Number of Hypoglycaemic Episodes|Number of hypoglycaemic episodes (severe episodes or episodes with plasma glucose (PG) below or equal to 3.9 mmol/L (70 mg/dL) with or without symptoms of hypoglycaemia) during the trial; nocturnal [11 p.m. - 7 a.m./23:00 - 07:00] and over the entire day (24 hours)|After 26 weeks and 52 weeks of treatment|Safety analysis set included all subjects receiving at least one dose of investigational product.|||episodes|||Number
2667631|NCT01513473|Secondary|Number of Treatment Emergent Adverse Events (TEAEs)|TEAE is defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.|After 26 weeks and 52 weeks of treatment|Safety analysis set included all subjects receiving at least one dose of investigational product.|||events|||Number
2667632|NCT01513473|Secondary|Change From Baseline in Fasting Blood Glucose (FPG) at 52 Weeks (Analysed by Central Laboratory)|Change from baseline in FPG after 52 weeks of treatment.|Week 0, week 52|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint. 338 subjects were considered, as 12 excluded from PP analysis set, 1 withdrawn, 11 subjects did not have a valid HbA1c measurements after 12 weeks.|||mmol/L||Standard Deviation|Mean
2668955|NCT01499810|Secondary|Change in Mean Nighttime Systolic BP||from baseline to 12 months||||mmHg||Standard Deviation|Mean
2667633|NCT01513473|Secondary|Change From Baseline in Fasting Blood Glucose (FPG) at 26 Weeks (Analysed by Central Laboratory)|Change from baseline in FPG after 26 weeks of treatment.|Week 0, week 26|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint. 338 subjects were considered, as 12 excluded from PP analysis set, 1 withdrawn, 11 subjects did not have a valid HbA1c measurements after 12 weeks. FPG samples were missing for 9 subjects.|||mmol/L||Standard Deviation|Mean
2667634|NCT01513473|Secondary|Change From Baseline in HbA1c (%) at 52 Weeks (Analysed by Central Laboratory)|Change from baseline in HbA1c (%) after 52 weeks of treatments.|Week 0, week 52|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2667635|NCT01513473|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin) (%) at 26 Weeks (Analysed by Central Laboratory)|Change from baseline in HbA1c (%) after 26 weeks of treatment.|Week 0, week 26|Full Analysis Set (FAS) Included all randomised subjects. LOCF values are presented for this endpoint.|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2667636|NCT01513460|Secondary|Mean Percentage of Days With Performance of Usual Activities|A 'day able to perform usual daily activities' was defined from diary data as any day where the patient was not prevented from performing their usual daily activities due to respiratory symptoms. The percentage of 'days able to perform usual daily activities' was derived and analyzed using a similar mixed model as specified for primary analysis as for the percentage of nights with 'no nighttime awakenings'.|12 weeks|Participants from the full analysis set (FAS), who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed only. The full analysis set included all randomized participants who received at least one dose of study drug.|||Percentage of days||Standard Error|Mean
2667637|NCT01513460|Secondary|Mean Percentage of Nights With 'no Nighttime Awakenings'|A night with 'no nighttime awakenings' is defined from diary data as any night where patient did not wake up due to symptoms. Total number of nights with 'no nighttime awakenings' over treatment period was divided by total number of nights where diary recordings have been made in order to derive percentage of 'no nighttime awakenings' which will be summarized by treatment and analyzed using a similar mixed model as specified for primary analysis. Diary data recorded during the 7 day run-in period was used to calculate baseline percentage of nights 'no nighttime awakenings'.|12 weeks|Participants from the full analysis set (FAS), who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed only. The full analysis set included all randomized participants who received at least one dose of study drug.|||Percentage of nights||Standard Error|Mean
2667638|NCT01513460|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Use|The total number of puffs of rescue medication used over the last 12 h recorded in the morning (nighttime use) and in the evening (daytime use) over the full 12 weeks was divided by the total number of days with non-missing rescue data to derive the mean daytime and nighttime number of puffs of rescue medication. Change from baseline in the mean daytime and nighttime number of puffs of rescue medication was analyzed as for the change from baseline in the mean daily number of puffs of rescue medication.|baseline, 12 weeks|Participants from the full analysis set (FAS), who had outcome measure data with applicable fixed effects/covariates according to the analysis model, were analyzed only. The full analysis set included all randomized participants who received at least one dose of study drug.|||puffs of rescue medication||Standard Error|Mean
2667639|NCT01513460|Secondary|Change From Baseline in Total Score of the St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) After 12 Weeks of Treatment|SGRQ-C is a health related quality of life questionnaire consisting of 40 items divided into two components: 1) symptoms, 2) activity& impacts. The lowest possible value is zero and the highest is 100. Higher values corresponded to greater impairment in quality of life. An analysis model included terms for treatment, baseline total SGRQ score, FEV1 and baseline smoking status. The model also contained as fixed effects the baseline total SGRQ score, FEV1 prior to inhalation of short acting bronchodilator, FEV1 post inhalation of short acting bronchodilator and stratification factors as covariates. A negative change from baseline indicates improvement.|12 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug.|||units on a scale||Standard Error|Mean
2667640|NCT01513460|Secondary|Change From Baseline in Mean Trough FEV1|Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15h and 23:45h after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45min and 15min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement.|baseline, 4 weeks, 8 weeks, 12 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug.|||Liters||Standard Error|Mean
2667641|NCT01513460|Secondary|Change From Baseline in Mean Trough FEV1 (Flu/Sal Versus NVA237/Tiotropium+Flu/Sal)|Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15h and 23:45h after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45min and 15min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement.|baseline, 4 weeks, 8 weeks, 12 weeks|Full Analysis Set: The full analysis set included all randomized participants who received at least one dose of study drug.|||Liters||Standard Error|Mean
2667663|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With a History of CDI in the 6 Months Prior to Enrollment|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|Treated participants with a history of CDI in the past 6 months.|||Percentage of participants|||Number
2668956|NCT01499810|Secondary|Change in Mean Nighttime Diastolic BP||from baseline to 6 months||||mmHg||Standard Deviation|Mean
2667642|NCT01513460|Primary|Change From Baseline in Mean Trough Forced Expiratory Volume in 1 Second (FEV1) (NVA237 Versus Tiotropium)|Spirometry was conducted according to internationally accepted standards. Trough FEV1 referred to the mean of FEV1 at 23:15 hours and 23:45 hours after the morning dose of study drug. The baseline was defined as the average of FEV1 values taken in the clinic 45 min and 15 min prior to the first dose of randomized treatment at Visit 3. A mixed model was used and contained treatment as a fixed effect with the baseline measurement of trough FEV1, FEV1 prior to inhalation of short acting bronchodilators, and FEV1 post-inhalation of bronchodilators and stratification factors as covariates. A positive change from baseline indicates improvement.|baseline, 12 weeks|Participants from the per-protocol set (PPS), who had values at both baseline and week 12, were included in the analysis. The PPS included all randomized participants who had at least one dose of study drug and who were without any major protocol or non-protocol deviations.|||liters||Standard Error|Mean
2667643|NCT01513447|Secondary|Total Local Anesthetic Consumption|It is anticipated that intracutaneous sterile water injections will decrease the amount of local anesthetic consumption.|24 hours||||milliliters||Standard Deviation|Mean
2667644|NCT01513447|Primary|Number of Participants With Breakthrough Back Labor Pain|It is anticipated that intracutaneous sterile water injections will provide additional pain relief as part of a multimodal analgesic regimen in women, especially in women with back labor.|within 24 hours||||participants|||Number
2667645|NCT01513330|Primary|Degree of Leakage. Each Baseplate Can Have a Score From 0-24 Points Were 0 is the Best Possible Outcome (No Leakage) and 24 Points is the Worst Possible Outcome (Full Plate Leakage)|Degree of leakage will be measured by a 25-point leakage scale (no leakage or up till 24 points of leakage), developed by Coloplast A/S. The subjects receive Petri dishes with pre-printed leakage scale on. The subject will place the Petri dish above the used baseplate and indicate where on the baseplate output appears. This is done by ticking of each area on the scale indicating the area of leakage.|14 days||||points on a scale|Participants|Standard Deviation|Mean
2667646|NCT01513317|Secondary|Median Number of Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS) During the 8 Weeks of Treatment Before Unblinding at Week 13||8 weeks|Intent-to-treat population: Included all randomized participants who completed Week 13 unblinding|||RBC Transfusions||Full Range|Median
2667647|NCT01513317|Secondary|Mean Changes From Baseline in Percentages of Bone Marrow Blast Cells at Week 13||Baseline and Week 13|Intent-to-treat population: Included all randomized participants with evaluable data at Week 13|||Percentage of Bone Marrow Blast Cells||Standard Deviation|Mean
2667648|NCT01513317|Secondary|Percentage of Participants Who Did Not Require a Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS) in the 8 Weeks of Treatment Before Unblinding at Week 13||8 weeks|Intent-to-treat population: Included all randomized participants|||Percentage of Participants|||Number
2667649|NCT01513317|Secondary|Percentage of Participants Achieving Hemoglobin Improvement (≥1.5 g/dL Increase From Baseline) Unrelated to Red Blood Cell (RBC) Transfusion at Week 13||Week 13|Intent-to-treat population: Included all randomized participants|||Percentage of Participants|||Number
2667650|NCT01513317|Secondary|Change From Baseline in the Mean Hemoglobin Concentrations at Week 13||Baseline and Week 13|Intent-to-treat population: Included all randomized participants with evaluable data at Week 13|||g/dL||Standard Deviation|Mean
2667651|NCT01513317|Primary|Percentage of Participants Who Achieved a Reduction in Red Blood Cell (RBC) Transfusions to Treat Anemia of Myelodysplastic Syndrome (MDS)|Reduction in RBC transfusions to treat the anemia of MDS is defined as a ≥50 percentage relative decrease and a ≥2 unit absolute decrease in RBC transfusions in the 8 weeks before the unblinding (scheduled to occur after 12 weeks of treatment) compared with RBC transfusions in the 8 weeks before the date the informed consent form was signed.|Up to Week 13|Intent-to-treat population: Included all randomized participants|||Percentage of participants|||Number
2667652|NCT01513291|Secondary|Percentage of Participants With at Least a 30% Reduction From Baseline in Monthly Migraine Days|Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Percentage of participants with at least 30% reduction in the monthly migraine days during Screening (Baseline) versus during the 12-week Treatment Period was analyzed using a generalized linear mixed effects model.|Baseline and average over Treatment Period (Weeks 0-12)|The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.|||Percentage of participants||95% Confidence Interval|Number
2667653|NCT01513291|Secondary|Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days|Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Percentage of participants with at least 50% reduction in the monthly migraine days during the 12-week Treatment Period versus during Screening (Baseline) was analyzed using a generalized linear mixed effects model.|Baseline and average over Treatment Period (Weeks 0-12)|The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.|||Percentage of participants||95% Confidence Interval|Number
2667664|NCT01513239|Primary|Percentage of Participants With One or More Infusion-specific Adverse Events on the Day of Infusion or the Day After Infusion|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.|Up to 24 hours|APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.|||Percentage of participants|||Number
2667654|NCT01513291|Secondary|Mean Change From Baseline in Monthly Headache Days|Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A headache was defined as headache pain of at least 30 minutes duration or for any duration for which headache treatment was administered. Change in the mean monthly headache days during Screening (Baseline) versus during the 12-week Treatment Period was assessed. A negative number indicates a reduction in mean monthly headache days.|Baseline and average over Treatment Period (Weeks 0-12)|The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.|||Days/month||Standard Error|Least Squares Mean
2667655|NCT01513291|Primary|Percentage of Participants Discontinued From Study Medication Due to an Adverse Event|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse event. Statistical analysis compared the Treatment Period arms only.|Treatment Period: Weeks 0-12; Run-out Period: Weeks 13-14|The population analyzed included all randomized participants who received at least one dose of double-blind study treatment.|||Percentage of participants|||Number
2667656|NCT01513291|Primary|Percentage of Participants With One or More Adverse Events|An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse event. Statistical analysis compared the Treatment Period arms only.|Treatment Period: Weeks 0-12; Run-out Period: Weeks 13-14|The population analyzed included all randomized participants who received at least one dose of double-blind study treatment.|||Percentage of participants|||Number
2667657|NCT01513291|Primary|Mean Change From Baseline in Monthly Migraine Days|Participants recorded data in the electronic migraine headache diary in the evening approximately one hour before bed and prior to taking study medication during Screening and the Treatment Period. A migraine was defined as a headache with at least one associated symptom of aura, photophobia, phonophobia, nausea, or vomiting. Change in the mean monthly migraine days during Screening (Baseline) versus during the 12-week Treatment Period was assessed. A negative number indicates a reduction in mean monthly migraine days.|Baseline and average over Treatment Period (Weeks 0-12)|The population analyzed included participants who received at least one dose of double-blind study treatment and had at least one evaluable endpoint measurement, including those with only a baseline measurement. This outcome measure applied only to the Treatment Period and was not analyzed for the Run-out Period.|||Days/month||Standard Error|Least Squares Mean
2667658|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With Compromised Immunity|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. Compromised immunity is an active hematological malignancy (including leukemia, lymphoma, multiple myeloma), an active malignancy requiring recent cytotoxic chemotherapy, receipt of a prior hematopoietic stem cell transplant, receipt of a prior solid organ transplant, asplenia, or neutropenia/pancytopenia due to other conditions.|12 weeks|Treated participants with compromised immunity|||Percentage of participants|||Number
2667659|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those 65 Years and Older|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|Treated participants 65 years and older.|||Percentage of participants|||Number
2667660|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With Clinically Severe CDI|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. Participants with clinically severe CDI have a Zar Score greater than or equal to 2 points based on the presence of 1 or more of the following: 1) age >60 years old (1 point); 2) body temperature >38.3°C (>100°F) (1 point); 3) albumin level ˂2.5 mg/dl (1 point); 4) peripheral white blood cell count >15,000 cells/mm^3 within 48 hours (1 point); 5) endoscopic evidence of pseudomembranous colitis (2 points); and 6) treatment in Intensive Care Unit (2 points).|12 weeks|Treated participants with clinically severe CDI|||Percentage of participants|||Number
2667661|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With an Epidemic Strain|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. An epidemic strain includes ribotypes 027, 014, 002, 001, 106 or 020.|12 weeks|Treated participants with an epidemic strain|||Percentage of participants|||Number
2667662|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With the 027 Ribotype|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen. The 027 ribotype is a more virulent, epidemic strain responsible for several outbreaks of disease associated with an increased risk of severity and mortality.|12 weeks|Treated participants with the 027 ribotype|||Percentage of participants|||Number
2667665|NCT01513239|Primary|Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event During 4 Weeks Following Infusion Treatment|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.|Up to 4 weeks|APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.|||Percentage of participants|||Number
2667666|NCT01513239|Primary|Percentage of Participants With One or More Serious Drug-related Adverse Events During 4 Weeks Following Infusion Treatment|A serious adverse event (SAE) is any AE occurring at any dose or during any use of the medicinal product that results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or other important medical events. A serious drug-related adverse event is determined by the investigator to be related to the drug.|Up to 4 weeks|APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.|||Percentage of participants|||Number
2667667|NCT01513239|Primary|Percentage of Participants With One or More Drug-related Adverse Events During 4 Weeks Following Infusion Treatment|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event. A drug-related adverse event is determined by the investigator to be related to the drug.|Up to 4 weeks|APaT based on the treatment actually received. One participant randomized to the MK-3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.|||Percentage of participants|||Number
2667668|NCT01513239|Primary|Percentage of Participants With One or More Adverse Events During 4 Weeks Following Infusion Treatment|An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an adverse event.|Up to 4 weeks|All Participants as Treated (APaT), based on the treatment actually received. One participant randomized to the MK- 3415A + SOC arm who was treated with MK-3415, but was not treated with MK-6072, was not analyzed.|||Percentage of participants|||Number
2667669|NCT01513239|Secondary|Percentage of Participants With CDI Recurrence in Those With Clinical Cure of the Initial CDI Episode|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|Treated participants who achieved a clinical cure of the initial CDI episode.|||Percentage of participants|||Number
2667670|NCT01513239|Secondary|Percentage of Participants With Global Cure|Global cure is defined as the clinical cure of the initial CDI episode with no CDI recurrence through Week 12. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|The FAS population consisting of all randomized participants with participants excluded for the failure to receive infusion of study medication; for lack of a positive local stool test for toxigenic C. difficile; or for failure to receive protocol defined standard of care therapy within a 1 day window of the infusion.|||Percentage of participants|||Number
2667671|NCT01513239|Primary|Percentage of Participants With CDI Recurrence|CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive lab stool test (local or central) for toxigenic C. difficile after clinical cure of the initial CDI episode. Clinical cure is defined as no diarrhea [2 or fewer loose stools per 24 hours] for 2 consecutive days following completion of SOC therapy for the initial CDI episode in participants who received =< 14 day regimen.|12 weeks|The (Full Analysis Set) FAS population consisting of all randomized participants with participants excluded for the failure to receive infusion of study medication; for lack of a positive local stool test for toxigenic C. difficile; or for failure to receive protocol defined standard of care therapy within a 1 day window of the infusion.|||Percentage of participants|||Number
2667672|NCT01513148|Secondary|Temperature (Degrees C)|Change in superficial skin temperature (degrees C) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time point = Temperature - Temperature at baseline. A positive variance int his calculation can be interpreted as being an increase from baseline or an increase in skin temperature|pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment||||Degrees Celsius||Standard Deviation|Mean
2667673|NCT01513148|Secondary|Negative Peak Latency (Milliseconds)|Change in negative peak latency (ms) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time period = negative peak latency NPL - baseline NPL. A positive variance can be interpreted as being increase from baseline or a prolonged or slowed NPL.|pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment||||ms||Standard Deviation|Mean
2667674|NCT01513148|Primary|Nerve Conduction Velocity (Meters Per Second)|Change in nerve conduction velocity (m/s) from pre-treatment to 0 minute (immediately after treatment), and at 2 min intervals after treatment until 10 minutes post treatment occurs. Calculated difference scores at each time point = nerve conduction velocity (NCV) - baseline NCV. A positive variance represented an increase from baseline and is interpreted as being an increase or faster velocity.|pre-treatment, 0 min, 2 min, 4 min, 6 min, 8 min and 10 min after treatment||||m/s||Standard Deviation|Mean
2667675|NCT01513122|Secondary|Mean Glucose Changes From Baseline to 48 Weeks||48 weeks||||mmol/L||95% Confidence Interval|Mean
2667681|NCT01512979|Secondary|Change From Baseline in FPG by Visit Over Time|The change from baseline is the FPG over time minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c, continuous baseline FPG in addition to week repeated within patient, week by baseline FPG interaction and week by treatment interaction.|Baseline, 6, 12, 18 and 24 weeks|Patients from PPCC, Observed Cases|||mg/dL||Standard Error|Mean
2667682|NCT01512979|Secondary|Occurrence of Treat to Target Efficacy Response (HbA1c <7.0%) After 24 Weeks of Treatment|The proportion of patients who achieved HbA1c below 7.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.|Baseline and 24 weeks|Patients from PPCC. Non-completers considered as failures.|||participants|||Number
2667683|NCT01512979|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 1.0% After 24 Weeks of Treatment)|The proportion of patients who achieved HbA1c lowering by at least 1.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.|Baseline and 24 weeks|Patients from PPCC. Non-completers considered as failures.|||participants|||Number
2667684|NCT01512979|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)|The proportion of patients who achieved HbA1c lowering by at least 0.5% after 24 weeks of treatment.The model includes treatment, and continuous baseline HbA1c.|Baseline and 24 weeks|Patients from PPCC. Non-completers considered as failures.|||participants|||Number
2667685|NCT01512979|Secondary|Change From Baseline in HbA1c by Visit Over Time|HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes treatment, continuous baseline HbA1c in addition to week repeated within patient, week by baseline HbA1c interaction and week by treatment interaction.|Baseline, 6, 12, 18 and 24 weeks|Patients from PPCC (observed cases)|||percent||Standard Error|Mean
2667686|NCT01512979|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment|The change from baseline is the FPG after 24 weeks minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose.|Baseline and 24 weeks|Patients from PPCC (LOCF)|||mg/dL||Standard Error|Mean
2667687|NCT01512979|Primary|Change From Baseline in HbA1c After 24 Weeks|HbA1c is measured as a percentage. The change from baseline is the Week 24 HbA1c minus the baseline HbA1c. Means are adjusted for treatment and continuous baseline HbA1c|Baseline and 24 weeks|Per Protocol completers cohort (PPCC): All patients randomised, treated with at least 1 dose of study drug, with a baseline HbA1c value without important protocol violations and who completed 24 weeks of treatment, were not treated with rescue medication and have an HbA1c measurement after 24 weeks of treatment.|||percent||Standard Error|Mean
2667688|NCT01512849|Primary|Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-7284|The percent inhibition of renal glucose reabsorption was calculated from renal glucose reabsorption (eGFR × plasma glucose AUC - urinary glucose excretion) on the preceding day and on the day of administration.|For 24 hours after each administration||||percent of RGR at baseline||95% Confidence Interval|Mean
2667689|NCT01512849|Primary|Effect of Renal Function on Urinary Glucose Excretion of TA-7284||For 24 hours after each administration||||g||95% Confidence Interval|Mean
2667690|NCT01512849|Primary|Effect of Renal Function on Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-7284||For 72 hours after each administration||||ng･h/mL||Standard Deviation|Mean
2667691|NCT01512849|Secondary|Clinical Laboratory Tests|Change from baseline in Clinical laboratory tests|For 72 hours after each administration|||||||
2667692|NCT01512849|Secondary|Vital Signs|Change from baseline in Vital signs (BP, PR and BT)|For 72 hours after each administration|||||||
2667693|NCT01512849|Secondary|12-lead Electrocardiogram (ECG)|Change from baseline in ECG parameters|For 72 hours after each administration|||||||
2667694|NCT01512849|Secondary|Adverse Events|Incidence and severity of AEs|Upto approximately 14 days after last administration|||||||
2667695|NCT01512849|Primary|Effect of Renal Function on Maximum Plasma Concentration of TA-7284||For 72 hours after each administration||||ng / mL||Standard Deviation|Mean
2667696|NCT01512797|Secondary|Active GLP-1|Active GLP-1 (Fasting and during a Mixed Meal Test). The Change in Fasting Active GLP-1 refers to the change in fasting active GLP-1 from pre-intervention time point to post-intervention time point. The Change in Peak Active GLP-1 refers to the change in the peak active GLP-1 level from the pre-intervention time point to post-intervention time point.|Pre-Intervention and Post-Intervention||||pmol/L||Standard Deviation|Mean
2667697|NCT01512797|Secondary|Occurrence of Side Effects In Relation to Sitagliptin|Side effects to Sitagliptin or Placebo were measured in study participants via Sigstad score questionnaire, while fasting and periodically during a 3 hour period after drinking a 200 kcal meal drink, before and after intervention. The Sigstad scoring system is based on the participants report of the occurrence of 16 symptoms suggestive of the dumping syndrome. Each symptom is given a different score. For example, desire to sit down (+4), breathlessness (+3), dizziness (+2), nausea (+1), vomiting (-4) etc.The scale can range from -5 to 34. Scores greater than or equal to 7, after glucose intake, are considered diagnostic of dumping syndrome.|6 weeks||||units on Sigstad scale||Standard Deviation|Mean
2667698|NCT01512797|Secondary|Effect of Sitagliptin vs Placebo on Satiety in Patients With Type 2 Diabetes After Gastric Bypass Surgery|"Satiety levels were measured in study participants while they were fasting and periodically over a three hour period after drinking a 200 kcal meal drink, before and after intervention via a Visual Analog Scale. Participants were asked to mark on a 0 to 150 millimeter scale their response to the following question: How full do you feel right now? with lower scores indicating not full at all and higher scores indicating extremely full."|Baseline and ~4 weeks||||mm||Standard Deviation|Mean
2667699|NCT01512797|Primary|Change in Area Under the Curve (AUC) Glucose Levels After Mixed Meal Test|Glucose levels were measured in study participants while fasting and periodically over 3 hours after drinking a 200 kcal mixed meal test, before and after intervention (Sitagliptin or Placebo). AUC was measured by trapezoidal method.|Baseline and ~4 weeks||||mmol/L/min||Standard Deviation|Mean
2667700|NCT01512797|Primary|Change in Postprandial Glucose Levels After Mixed Meal Test|Glucose levels were measured in study participants while fasting and periodically over 3 hours after drinking a 200 kcal mixed meal test, before and after intervention (Sitagliptin or Placebo).|Baseline and ~4 weeks|All patients completed study in both arms.|||mmol/L||Standard Deviation|Mean
2667702|NCT01512758|Secondary|Duration of Response|DOR is defined as the time from the date of first documentation of a CR response to the date of first documentation of PD according to IWG criteria or RECIST criteria 1.1. IWG PD is defined as PD is defined as any new lesion or increase by >50% of previously involved sites from nadir. RECIST PD is defined as unequivocal progression of existing non-target lesions.|First documented response until disease progression; approximately 12 months|Safety Population is defined as all participants who received at least one dose of alisertib. Participants with response were evaluated.|||days||Full Range|Median
2667703|NCT01512758|Secondary|Best Overall Response Rate Based on Investigator Assessment|Best overall response rate is defined as the percentage of participants with complete response (CR) and/or partial response (PR) as assessed by the Investigator using Lymphoma International Working Group (IWG) Criteria or Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 for target lesions and assessed by CT, PET or MRI. IWG criteria for CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites. RECIST response criteria is defined as: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions.|Baseline and every 2 cycles for up to 24 months or until progressive disease|Safety Population is defined as all participants who received at least one dose of alisertib.|||percentage of participants|||Number
2667704|NCT01512758|Primary|CLss/F: Apparent Clearance After Extravascular Administration, at Steady State, Calculated Using AUCτ for Alisertib||Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose|PK Population is defined as all participants with sufficient dosing and PK concentration time data to reliably estimate PK parameters.|||L/hr||Standard Deviation|Mean
2667705|NCT01512758|Primary|PTR: Peak Trough Ratio During a Dosing Interval, at Steady State for Alisertib||Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose|PK Population is defined as all participants with sufficient dosing and PK concentration time data to reliably estimate PK parameters.|||ratio||Standard Deviation|Mean
2667706|NCT01512758|Primary|Rac: Accumulation Ratio for Alisertib||Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose|PK Population is defined as all participants with sufficient dosing and PK concentration time data to reliably estimate PK parameters.|||ratio||Standard Deviation|Mean
2667707|NCT01512758|Primary|T1/2: Terminal Half-Life for Alisertib||Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose|PK Population is defined as all participants with sufficient dosing and PK concentration time data to reliably estimate PK parameters.|||hr||Standard Deviation|Mean
2667708|NCT01512758|Primary|Dose Normalized AUCτ: Area Under the Concentration-Time Curve From Time 0 to Time t for Alisertib|Dose normalized AUCτ was obtained using AUCτ divided by alisertib dose in milligrams.|Cycle 1 Day 7 predose and at multiple time points (up to 12 hours) postdose|PK Population is defined as all participants with sufficient dosing and PK concentration time data to reliably estimate PK parameters.|||nM*hr/mg||Standard Deviation|Mean
2667709|NCT01512758|Primary|AUCτ: Area Under the Concentration-Time Curve From Time 0 to End of Dosing Interval (τ) for Alisertib||Cycle 1 Days 1 and 7 predose and at multiple time points (up to 12 hours) postdose|"PK Population is defined as all participants with sufficient dosing and PK concentration time data to reliably estimate PK parameters. n in the category is the number of participants with data available at the given time-point."|||nM*hr||Standard Deviation|Mean
2667710|NCT01512758|Primary|Tmax: Time to First Occurrence of Cmax for Alisertib||Cycle 1 Days 1 and 7 predose and at multiple time points (up to 12 hours) postdose|"PK Population is defined as all participants with sufficient dosing and PK concentration time data to reliably estimate PK parameters. n in the category is the number of participants with data available at the given time-point."|||hr||Full Range|Median
2667711|NCT01512758|Primary|Cmax: Maximum Observed Concentration for Alisertib||Cycle 1 Days 1 and 7 predose and at multiple time points (up to 12 hours) postdose|"Pharmacokinetic (PK) Population is defined as all participants with sufficient dosing and PK concentration time data to reliably estimate PK parameters. n in the category is the number of participants with data available at the given time-point."|||nM||Standard Deviation|Mean
2667712|NCT01512758|Primary|Number of Participants With Clinically Significant Changes in Vital Signs Reported as Adverse Events|Vital signs (blood pressure, pulse rate, and oral temperature) measurements were collected throughout the study.|First dose to 30 days past last dose (Up to 12.1 Months)|Safety Population is defined as all participants who received at least one dose of alisertib.|||Participants|||Count of Participants
2667713|NCT01512758|Primary|Number of Participants With Abnormal Clinical Laboratory Values Reported as Adverse Events|Laboratory AEs in the following system organ classes (SOCs) are reported: blood and lymphatic system disorders, investigations, and metabolism and nutrition disorders. An abnormal laboratory value was assessed as an AE if that value lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from baseline. A treatment¬-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose to 30 days past last dose (Up to 12.1 Months)|Safety Population is defined as all participants who received at least one dose of alisertib.|||Participants|||Count of Participants
2667714|NCT01512758|Primary|Number of Participants With Adverse Events and Serious Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) A serious is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|First dose to 30 days past last dose (Up to 12.1 Months)|Safety Population is defined as all participants who received at least one dose of alisertib.|||Participants|||Count of Participants
2667776|NCT01512160|Secondary|12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)|Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.|Screening, Day 1, 2, 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time points for each arm group respectively.|||beats per minute||Standard Deviation|Mean
2667715|NCT01512758|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)|MTD was defined as highest dose at which <2 participants experienced a dose-limiting toxicity (DLT). DLT was defined as any of the following events considered possibly related to therapy with alisertib by the investigator: 1. Grade 4 neutropenia (absolute neutrophil count <500 cells/mm^3) for >7 days; 2. Grade 4 neutropenia with fever (oral or ear temperature ≥38.5°C); 3. Grade 4 thrombocytopenia (platelets <25,000/mm^3) for >7 days; 4. Platelet count <10,000 cells/mm^3; 5. ≥Grade 3 thrombocytopenia with clinically significant bleeding; 6. Delay in initiation of subsequent cycle by >7 days due to treatment-related toxicity; 7. ≥Grade 3 nonhematological toxicity except following: a. ≥Grade 3 nausea and/or emesis in the absence of optimal antiemetic therapy; b. ≥Grade 3 diarrhea in the absence of optimal supportive therapy; c. Grade 3 fatigue lasting <1 week; d. Other Grade 3 nonhematological toxicity that can be safely and reliably controlled to ≤Grade 2 with appropriate treatment.|Treatment Cycle 1|DLT-Evaluable population is defined as participants with a common race who had not used granulocyte colony-stimulating factor (G-CSF) in cycle 1, and either experienced DLT during Cycle 1 or received at least 85% of planned doses of alisertib and have sufficient follow up data to allow investigator and sponsor to determine whether a DLT occurred.|||mg|||Number
2667716|NCT01512745|Secondary|Percentage of Participants With Adverse Events||30 months||||percentage of participants|||Number
2667717|NCT01512745|Secondary|Objective Response Rate(ORR)|Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR)|30 months||||percentage of participants|||Number
2667718|NCT01512745|Secondary|Disease Control Rate(DCR)|Disease control is defined as the proportion of patients who had a best response rating of complete response, partial response, or stable disease, and lasted at least 4 weeks.|30 months||||percentage of participants|||Number
2667719|NCT01512745|Primary|Overall Survival(OS)|Overall Survival of the Participants|30 months||||month||95% Confidence Interval|Median
2667720|NCT01512745|Primary|Progression Free Survival(PFS)|Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).|30 months||||month||95% Confidence Interval|Median
2667721|NCT01512693|Secondary|Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose|Apparent terminal half-life is the time required to divide the plasma (serum) concentration by two after reaching pseudo-equilibrium. (Note: it is not the time required to eliminate half the administered dose.) For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of t1/2. Results are presented using harmonic mean and jackknife standard deviation.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.|||hr||Standard Deviation|Mean
2667722|NCT01512693|Secondary|Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose|For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Tmax.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.|||hr||Full Range|Median
2667723|NCT01512693|Secondary|Maximum Concentration (Cmax) of MK-0822 After Single Dose|For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Cmax.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.|||nM||95% Confidence Interval|Least Squares Mean
2667724|NCT01512693|Primary|Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose|For healthy and moderate hepatic insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of AUC0-∞ (Total AUC). AUC0-∞ is a measure of total drug exposure.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.|||μM*hr||95% Confidence Interval|Least Squares Mean
2667725|NCT01512667|Secondary|Apparent Terminal Half-life (t1/2) of MK-0822 After Single Dose|For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of t1/2.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all matched participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.|||hr||Geometric Coefficient of Variation|Geometric Mean
2667726|NCT01512667|Secondary|Time to Maximum Concentration (Tmax) of MK-0822 After Single Dose|For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Tmax.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all matched participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.|||hr||Full Range|Median
2667727|NCT01512667|Secondary|Maximum Concentration (Cmax) of MK-0822 After Single Dose|For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of Cmax.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all matched participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.|||nM||95% Confidence Interval|Least Squares Mean
2668957|NCT01499810|Secondary|Change in Mean Nighttime Systolic BP||from baseline to 6 months||||mmHg||Standard Deviation|Mean
2667728|NCT01512667|Primary|Area Under the Concentration-time Curve of MK-0822 From Time 0 to Infinity (AUC0-∞) After Single Dose|For healthy and severe renal insufficiency participants, plasma samples were collected from predose to 336 hours postdose for determination of AUC0-∞ (Total AUC). AUC0-∞ is a measure of total drug exposure.|Pre-dose and 1, 2, 4, 6, 9, 12, 16, 24, 32, 48, 72, 96, 120, 168, 240, and 336 hours postdose|The per protocol population consisted of all matched participants who complied with the protocol sufficiently to ensure that results will likely exhibit the effects of treatment according to the underlying scientific model.|||μM*hr||95% Confidence Interval|Least Squares Mean
2667729|NCT01512446|Secondary|Combination of New Osteoporotic Fractures and Deaths|Number of participants with a new osteoporotic fracture or death|From baseline to study termination (mean duration 5.6 months)|Full Analysis Set (all randomized participants)|||Participants|||Count of Participants
2667730|NCT01512446|Secondary|Mortality|Number of deaths|From baseline to study termination (mean duration 5.6 months)|Full Analysis Set (all randomized participants)|||Participants|||Count of Participants
2667731|NCT01512446|Primary|Number of New Osteoporotic Fractures|Number of new osteoporotic fractures. All fractures which occurred without high impact trauma (i.e. atraumatically, minor accidents and falls from standing height and lower) were regarded as osteoporotic fractures, except for fractures of fingers, face, skull and toes.|From baseline to study termination (mean duration 5.6 months)|Full Analysis Set (all randomized participants)|||osteoporotic fractures|||Number
2667732|NCT01512368|Secondary|Change From Baseline Fasting Glucose Acutely and at Two Weeks|Serum measurement of glucose was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.|||mg/dL||Standard Deviation|Mean
2667733|NCT01512368|Secondary|Change From Baseline Total Adiponectin Acutely and at Two Weeks|Serum measurement of total adiponectin was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.|||ng/mL||Inter-Quartile Range|Median
2667734|NCT01512368|Secondary|Change From Baseline Leptin Acutely and at Two Weeks|Serum measurement of leptin was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.|||ng/mL||Inter-Quartile Range|Median
2667735|NCT01512368|Secondary|Change From Baseline Epinephrine Acutely and at Two Weeks|Serum measurement of epinephrine was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report (5), we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.|||pg/mL||Inter-Quartile Range|Median
2667736|NCT01512368|Secondary|Change From Baseline Free Fatty Acids (FFAs) Acutely and at Two Weeks|Serum measurement of free fatty acids (FFAs) was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated.|||mg/dL||Inter-Quartile Range|Median
2667737|NCT01512368|Primary|Change From Baseline Fibroblast Growth Factor 21 (FGF21) Acutely and at Two Weeks|Serum measurement of FGF21 using human ELISA kit was done at baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise.|Baseline, 1hr and 4 hr after a bout of exercise, and repeated after two weeks of daily supervised exercise|The sample size was calculated using the formula for means for two-tailed comparisons. According to our previous report, we expected a minimal change of 80 ng/l of FGF21 after two weeks of physical activity. Using a SD of 160 ng/l with an alfa of 0.05 and a study power of 80%, a total of 60 subjects were calculated. All participants were analyzed.|||ng/L||Inter-Quartile Range|Median
2667738|NCT01512264|Secondary|Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Long-term Follow Up|"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB)."|3 months post treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||index score||Standard Deviation|Mean
2667801|NCT01512108|Secondary|Change in FPG From Baseline to Week 52|Estimated mean change from baseline in FPG after 52 Weeks of treatment|Week 0, week 52|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products and missing data were imputed using last observation carried forward (LOCF). One subject did not contribute to the statistical analysis at Week 52.|||mmol/L||Standard Error|Mean
2668958|NCT01499810|Secondary|Change in Mean Daytime Diastolic BP||from baseline to 12 months||||mmHg||Standard Deviation|Mean
2668959|NCT01499810|Secondary|Change in Mean Daytime Systolic BP||from baseline to 12 months||||mmHg||Standard Deviation|Mean
2667739|NCT01512264|Secondary|Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Immediate Follow Up|"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB)."|within 1 week post treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||index score||Standard Deviation|Mean
2667740|NCT01512264|Secondary|Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Baseline|"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB)."|Baseline: 1 week before the first nerTMS treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||index score||Standard Deviation|Mean
2667741|NCT01512264|Secondary|Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Long-term Follow Up|"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB)."|3 months post treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||index score||Standard Deviation|Mean
2667742|NCT01512264|Secondary|Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Immediate Follow Up|"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB)."|within 1 week post treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||index score||Standard Deviation|Mean
2667743|NCT01512264|Secondary|Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Baseline|"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB)."|Baseline: 1 week before the first nerTMS treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||index score||Standard Deviation|Mean
2667744|NCT01512264|Secondary|Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Long-term Follow Up|"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB)."|3 months post treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||index score||Standard Deviation|Mean
2667745|NCT01512264|Secondary|Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Immediate Follow-up|"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB)."|within 1 week post treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||index score||Standard Deviation|Mean
2667746|NCT01512264|Secondary|Change in Language Laterilazation as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Baseline|"Laterality index (LI) is a measure of language lateralization to a hemisphere - it ranges from -1 (or -100%) indicating left-hemispheric lateralization to 1 (or 100%) indicating right-hemispheric lateralization. A change from the baseline visit to the post-treatment visit is a neuroimaging (fMRI) outcome measure in this study. Change in LI does not indicate improvement or worsening but rather shift in lateralization of the language function representation in the brain that may be correlated with change in linguistic testing (e.g., WAB)."|Baseline: 1 week before the first nerTMS treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||Index score||Standard Deviation|Mean
2667802|NCT01512108|Secondary|Change in HbA1c From Baseline to Week 52|Estimated mean change in HbA1c from baseline after 52 Weeks of treatment|Week 0, week 52|Full analysis set (FAS) included all randomised subjects who received at least one dose of trial products and missing data were imputed using last observation carried forward (LOCF). One subject did not contribute to the statistical analysis at Week 52.|||percentage of glycosylated haemoglobin||Standard Error|Mean
2668960|NCT01499810|Secondary|Change in Mean Daytime Diastolic BP||from baseline to 6 months||||mmHg||Standard Deviation|Mean
2668961|NCT01499810|Secondary|Change in Mean Daytime Systolic BP||from baseline to 6 months||||mmHg||Standard Deviation|Mean
2667747|NCT01512264|Primary|Western Aphasia Battery (WAB) - Long-Term Follow-Up|WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.|3 months post treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||units on a scale||Standard Deviation|Mean
2667748|NCT01512264|Primary|Western Aphasia Battery (WAB) - Immediate Follow-Up|WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.|within 1 week post treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||units on a scale||Standard Deviation|Mean
2667749|NCT01512264|Primary|Western Aphasia Battery (WAB) - Baseline|WAB assesses linguistic skills most frequently affected by aphasia, plus key nonlinguistic skills, and provides differential diagnosis information. Adaptable to various administration settings from hospital room to clinic, it provides a baseline level of performance to measure change over time.The scoring provides two main totals, in addition to the subscale scores. These are the Aphasia Quotient (AQ) score and Cortical Quotient (CQ) score. AQ can essentially be thought of as a measure of language ability, whilst CQ is a more general measure of intellectual ability and includes all the subscales. Administration of the Western Aphasia Battery (WAB) yields a total score termed the Aphasia Quotient (AQ), which is said to reflect the severity of the spoken language deficit in aphasia. This score is a weighted composite of performance on 10 separate WAB subtests. Scores rate severity as follows: 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild.|Baseline: 1 week before the first nerTMS treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||units on a scale||Standard Deviation|Mean
2667750|NCT01512264|Primary|Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Long Term Follow-up|"The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. C, F, L) and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia."|3 months post treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||words generated||Standard Deviation|Mean
2667751|NCT01512264|Primary|Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Immediate Follow-up|"The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. C, F, L) and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia."|within 1 week post treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||words generated||Standard Deviation|Mean
2667752|NCT01512264|Primary|Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Baseline|"The Controlled Word Association Test is also a verbal fluency test. In this test participants produce as many words as possible given a specific letter for a specified time period. In the COWAT participants were given 3 Letters (i.e. C, F, L) and asked to produce as many words that begin with that letter (excluding proper nouns) as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia."|1 week before the first nerTMS treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||words generated||Standard Deviation|Mean
2667753|NCT01512264|Primary|Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Long Term Follow-up|"The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. Animals, Fruits) and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia."|3 months post treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||words generated||Standard Deviation|Mean
2667871|NCT01511107|Secondary|The Distribution of Children for Whom Diaper Dermatitis Was Reported and Associated With Study Product|Diaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent and is limited to events associated with study product.|Day 1 of administration of study product until day 16 for all episodes|The analysis was ITT. The number of participants equals the number of children randomized and eligible.|||participants|||Number
2667754|NCT01512264|Primary|Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Immediate Follow-up|"The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. Animals, Fruits) and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia."|within 1 week post treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||units on a scale||Standard Deviation|Mean
2667755|NCT01512264|Primary|Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Baseline|"The Semantic Fluency Test is used to assess verbal ability. It is a psychological test where participants produce as many words as possible in a given category for a specified time period. In the SFT participants were given 3 categories (i.e. Animals, Fruits) and asked to produce as many words in that category as they can in 60 seconds. Scoring of the test included the sum of the number of spontaneous words that were generated in each category. This measure does not have a theoretical maximum; however, the more words generated indicates higher verbal ability which can indicate changes related to aphasia."|1 week before the first nerTMS treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||words generated||Standard Deviation|Mean
2667756|NCT01512264|Primary|Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Long Term Follow-up|60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.|3 months post treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||units on a scale||Standard Deviation|Mean
2667757|NCT01512264|Primary|Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Immediate Follow-Up|60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.|within 1 week post treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||units on a scale||Standard Deviation|Mean
2667758|NCT01512264|Primary|Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Baseline|60-item test of visual confrontation naming for aphasia. In the BNT, subjects are shown line drawings of common objects one at a time and asked to name them orally. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cuing and after semantic cuing. The scale for scoring is 0-60 with 0 being no spontaneous correct answers and 60 being all correct answers.|Baseline: 1 week before the first nerTMS treatment|1 participant from control group was unable to be analyzed due to loss of follow up.|||units on a scale||Standard Deviation|Mean
2667759|NCT01512251|Secondary|Secondary Outcome 6 Phase 2 - MAPK Pathway Gene Expression Levels|Responding tumors lack gene expression signatures of MAPK pathway activation, and progressing tumors demonstrate gene expression signatures of MAPK pathway activation - determined by laboratory tests and tumor assessments.|No time limit|Data not collected: study was terminated early due to dose limiting toxicities.||||||
2667760|NCT01512251|Secondary|Secondary Outcome 5 Phase 2 - PI3K Pathway Gene Expression Levels|Responding tumors lack gene expression signatures of PI3K pathway activation, and progressing tumors demonstrate gene expression signatures of PI3K pathway activation - determined by laboratory tests and tumor assessments.|No time limit|Data not collected: study was terminated early due to dose limiting toxicities.||||||
2667761|NCT01512251|Secondary|Secondary Outcome 4 Phase 2 - PI3K-pathway Signaling Reduction Levels|Greater reduction in PI3K-pathway signaling associated with better PFS determined by laboratory tests and tumor assessments.|No time limit|Data not collected: study was terminated early due to dose limiting toxicities.||||||
2667762|NCT01512251|Secondary|Secondary Outcome 3 Phase 2 - PTEN Expression|PTEN expression associated with better PFS determined by laboratory tests.|No time limit|Data not collected: study was terminated early due to dose limiting toxicities.||||||
2667763|NCT01512251|Secondary|Secondary Outcome 2 Phase 2 - Safety and Tolerability|Determined by clinical and laboratory tests, and AE assessments|During study treatment, up to 2 years|Data not collected: study was terminated early due to dose limiting toxicities.||||||
2667764|NCT01512251|Secondary|Secondary Outcome 1 Phase 2 - Objective Response Rate|"Objective response rate determined by tumor assessments, clinical tests and laboratory tests.~Data not collected: study was terminated early due to dose limiting toxicities."|Day 28 (+/- 3) of even-numbered treatment cycles until progression|||||||
2667765|NCT01512251|Primary|Phase 2 - Progression-free Survival Rate|6 month progression-free survival rate (PFS6) determined by tumor assessments, clinical tests and laboratory tests|6 months|Data were not collected, study never advanced to Phase II.||||||
2667766|NCT01512251|Primary|Phase 1 - Safety & Recommended Phase 2 Dose (RP2D)|RP2D determined by MTD, post-DLT period toxicity, and pharmacokinetic data|28 days||||mg|||Number
2667767|NCT01512225|Secondary|Provision of Breast Milk at 6 Weeks Post Term Gestation|Provision of breast milk at 6 weeks post term gestation as primary source of nutrition|6 weeks post term gestation||||Participants|||Count of Participants
2667768|NCT01512225|Secondary|Provision of Breast Milk at Term Gestation|provision of breast milk as the primary source of nutrition|term gestation||||Participants|||Count of Participants
2667769|NCT01512225|Secondary|Mean Volume Change on the Volume of Milk From Day 15 to Day 28|change on the volume of milk from day 15 to day 28 between the two groups|day 15 and day 28||||millilitres||Full Range|Mean
2667770|NCT01512225|Secondary|Mean Volume Change From Day 0 to Day 14|change on the volume of milk from day 0 to day 14 between the two groups|days 0 and 14||||millilitres||Full Range|Mean
2667771|NCT01512225|Secondary|Mean Breast Milk Volumes on Day 28|Mean milk volumes between the two groups at 28 days of study intervention|day 0 and 28||||millilitres||Standard Deviation|Mean
2667777|NCT01512160|Secondary|12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)|Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization) and QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia's formula (QTcF = QT divided by cube root of RR interval).|Screening, Day 1, 2, 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time points for each arm group respectively.|||milliseconds||Standard Deviation|Mean
2667778|NCT01512160|Secondary|Supine Systolic and Diastolic Blood Pressure (BP)|Supine systolic and diastolic BP was measured after the participant has been rested in the supine position for at least 5 minutes with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg). The same arm and position and same size BP cuff was used throughout the study.|Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time point.|||mmHg||Standard Deviation|Mean
2667779|NCT01512160|Secondary|Number of Participants With Clinically Significant Laboratory Test Abnormality|Hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (urine pH, glucose, ketones, protein, blood, nitrite, leukocyte esterase), and clinical chemistry (glucose) were performed.|Baseline up to Day 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
2667780|NCT01512160|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 10 to 14.|Baseline up to Day 10-14 (Follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
2667781|NCT01512160|Secondary|Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of Ibuprofen|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.|0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.|||mcg*hr/mL||Standard Deviation|Geometric Mean
2667782|NCT01512160|Secondary|Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of Ibuprofen|AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.|0 (pre-dose), 1, 2, 4, 6 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.|||microgram*hour per milliliter (mcg*h/mL)||Standard Deviation|Geometric Mean
2667783|NCT01512160|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen||0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.|||hours||Full Range|Median
2667784|NCT01512160|Secondary|Maximum Observed Plasma Concentration (Cmax) of Ibuprofen||0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.|||microgram per milliliter (mcg/mL)||Standard Deviation|Geometric Mean
2667785|NCT01512160|Secondary|Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of PF-04531083|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.|0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2667786|NCT01512160|Secondary|Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of PF-04531083|AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.|0 (pre-dose), 1, 2, 4, 6 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2667787|NCT01512160|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04531083||0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.|||hours||Full Range|Median
2667788|NCT01512160|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-04531083||0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose|Pharmacokinetic (PK) analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2667789|NCT01512160|Secondary|Participant Satisfaction Questionnaire|"Participant's response to 2 questions about how satisfied or dissatisfied they were with the study medication for PR and overall performance (OP) was obtained on a 5 point categorical scale, 1=very dissatisfied, 2=somewhat dissatisfied, 3=neither satisfied nor dissatisfied, 4=somewhat satisfied and 5=very satisfied."|6, 24 hours, prior to RM|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Participants analyzed in this outcome for prior to rescue medication included only those participants who took rescue medication.|||participants|||Number
2668962|NCT01499810|Secondary|Change in Echocardiographic Left Ventricular Mass||from baseline to 12 months|Number of participants assessed by EchoCG at 12 months|||g||Standard Deviation|Mean
2667790|NCT01512160|Secondary|Participant Global Evaluation of Study Medication|Participant rated the study medication that they received during the study, at both the 6 hour and 24 hour observations or at time of rescue medication, whichever occurs first, by answering the following question on 6-point categorical scale: how would you rate the study medication you received for pain? 5=excellent, 4=very good, 3=good, 2=fair and 1=poor.|6, 24 hours, prior to RM|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Participants analyzed in this outcome for prior to rescue medication included only those participants who took rescue medication.|||participants|||Number
2667791|NCT01512160|Secondary|Number of Participants With Rescue Medication|Participants who did not experience adequate pain relief after 90 minutes post-dose of study medication had received 2 tablets of acetaminophen 500 mg as rescue medication.|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.|||participants|||Number
2667792|NCT01512160|Secondary|Time to First Use of Rescue Medication|Time to first use of rescue medication (2 tablets of acetaminophen 500 mg as starting dose) was calculated by subtracting time of first administration of study medication from the rescue medication administration time.|1.5 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.|||hours||90% Confidence Interval|Median
2667793|NCT01512160|Secondary|Time to Onset of First Meaningful Pain Relief (PR)|Participants evaluated the time to first meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief.|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.|||hours||90% Confidence Interval|Median
2667794|NCT01512160|Secondary|Time to Onset of First Perceptible Pain Relief (PR)|Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief.|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.|||hours||90% Confidence Interval|Median
2667795|NCT01512160|Secondary|Total Pain Relief (TOTPAR) Score From 0 to 24 Hours|TOTPAR [24] was defined as the area under the pain relief (PR) curve through the 24 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR assumed to be 0 at time=0. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 24 hours post-dose. Total score range for TOTPAR [24]: 0 (worst) - 96 (best), higher value of TOTPAR indicated greater degree of PR.|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing TOTPAR values were imputed using LOCF.|||units on a scale*hour||Standard Error|Least Squares Mean
2667796|NCT01512160|Secondary|Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours|Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. The SPID at 6 and 24 hours was derived by calculating the area under the PID effect curve through the first 6 or 24 hours post-dose respectively. The AUC was calculated using the trapezoid rule. Total score range: -6 (worst) to 18 (best) for SPID 0-6, and -24 (worst) to 72 (best) for SPID 0-24. Higher value of SPID indicated greater degree of pain relief.|0 to 6, 0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing SPID values were imputed using LOCF.|||units on a scale*hour||Standard Error|Least Squares Mean
2667797|NCT01512160|Secondary|Time-specific Pain Intensity Difference (PID) Score|Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit.|15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to RM|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. n=number of participants evaluable for this measure at specified time point.|||units on a scale||Standard Deviation|Mean
2667798|NCT01512160|Secondary|Time-specific Pain Relief (PR) Score|PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete) at each relevant time points.|0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to rescue medication (RM)|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. n=number of participants evaluable for this measure at specified time point.|||units on a scale||Standard Deviation|Mean
2667799|NCT01512160|Secondary|Number of Participants With Peak Pain Relief (PPR)|PPR was defined as the highest PR score achieved at any time point during the evaluation period, prior to rescue medication. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).|0 to 24 hours|FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.|||participants|||Number
2667800|NCT01512160|Primary|Total Pain Relief (TOTPAR) Score From 0 to 6 Hours|TOTPAR [6] was defined as the area under the pain relief (PR) curve through the first 6 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR was assumed to be 0 at time=0. PR assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 6 hours post-dose. Total score range for TOTPAR [6]: 0 (worst) - 24 (best), higher value of TOTPAR indicated greater degree of PR.|0 to 6 hours|Full analysis set (FAS) included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing PR values were imputed using last observation carried forward (LOCF).|||units on a scale*hour||Standard Error|Least Squares Mean
2667803|NCT01512108|Secondary|Number of Confirmed Hypoglycaemic Episodes|Confirmed hypoglycaemic episodes consisted of the pool of episodes of severe hypoglycaemia as well as minor hypoglycaemic episodes [An episode with symptoms consistent with hypoglycaemia with confirmation by plasma glucose <3.1 mmol/L (56 mg/dL) or full blood glucose <2.8 mmol/L (50 mg/dL) and which is handled by the subject himself or herself or any asymptomatic PG value <3.1 mmol/L (56 mg/dL) or full blood glucose value <2.8 mmol/L (50 mg/dL)] with a confirmed plasma glucose value of less than 3.1 mmol/L (56 mg/dL).|Week 0 to Week 52|Safety analysis set includes all subjects who received at least one dose of the trial product.|||episodes|||Number
2667804|NCT01512108|Primary|Incidence of Treatment Emergent Adverse Events (AEs)|Adverse events were defined as events occurring after administration of trial product and no later than 7 days after last day of treatment. Severe AEs: considerable interference with subject's daily activities. Moderate AEs: Marked symptoms, moderate interference with the subject's daily activities. Mild AEs: No or transient symptoms, no interference with the subject's daily activities. Serious AEs: AEs that resulted in any of the following: death, a life-threatening experience, hospitalization/prolongation of existing hospitalization, persistent/significant disability, and congenital anomaly.|Week 0 to Week 52 + 7 days|Safety analysis set included all subjects who received at least one dose of the trial product.|||Events/100 years of patient exposure|||Number
2667805|NCT01511978|Secondary|Self-assessment of LEMS-related Weakness, W-SAS|The last post-dose self-assessment of LEMS-related weakness from the withdrawal period with categories of much much weaker (-3), much weaker (-2), somewhat weaker (-1), about the same (0), somewhat stronger (1), much stronger (2), and much much stronger (3).|Participants were followed for up to 7 days||||units on a scale||Standard Deviation|Mean
2667806|NCT01511978|Primary|Number of Participants With 30% or More Deterioration in Triple Timed Up & Go (3TUG) Test, Compared to Time-matched Baseline|"The 3TUG time obtained 2 hours after the last dose of the withdrawal period (i.e., at time of theoretical peak drug effect) was compared to the average time-matched 3TUG tests performed during 2 days of baseline observation prior to randomization.~The study endpoint was a change of more than 30% in the final post-dose 3TUG during the withdrawal period and was based on blinded readings of video recordings of 3TUG tests."|Baseline period (days 0, 1, 2); Randomized treatment period (starting with last dose of day 2, and days 3, 4, 5, and ending with first dose on day 6 when pre-randomization regimen was resumed, or rescue, if indicated sooner)||||Participants|||Count of Participants
2667807|NCT01511939|Primary|Change From Baseline to Week 4 in Laboratory Results of Platelet Aggregation|Platelet Aggregation will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.|Baseline to Week 4|"For this analysis, the subject who was taking warfarin and aspirin was included in both the Pennsaid, warfarin group and the Pennsaid, aspirin and/or clopidogrel group, and the subject who was taking dabigatran and aspirin was included in both the Pennsaid, dabigatran group and the Pennsaid, aspirin and/or clopidogrel group."|||Seconds||Full Range|Mean
2667808|NCT01511939|Primary|Change From Baseline to Week 4 in Laboratory Results of Partial Thromboplastin Time (PTT)|PTT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.|Baseline to Week 4|"Two subjects who completed the study were taking both an anticoagulant medication and aspirin. For this analysis, the subject who was taking warfarin and aspirin was included only in the Pennsaid, warfarin group, and the subject who was taking dabigatran and aspirin was included only in the Pennsaid, dabigatran group."|||Seconds||Full Range|Mean
2667809|NCT01511939|Primary|Change From Baseline to Week 4 in Laboratory Results of International Normalized Ratio (INR)|INR will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.|Baseline to Week 4|"Two subjects who completed the study were taking both an anticoagulant medication and aspirin. For this analysis, the subject who was taking warfarin and aspirin was included only in the Pennsaid, warfarin group, and the subject who was taking dabigatran and aspirin was included only in the Pennsaid, dabigatran group."|||ratio||Full Range|Mean
2667810|NCT01511939|Primary|Change From Baseline to Week 4 in Laboratory Results of Prothrombin Time (PT)|PT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.|Baseline to week 4|"Two subjects who completed the study were taking both an anticoagulant medication and aspirin. For this analysis, the subject who was taking warfarin and aspirin was included only in the Pennsaid, warfarin group, and the subject who was taking dabigatran and aspirin was included only in the Pennsaid, dabigatran group."|||seconds||Full Range|Mean
2667811|NCT01511809|Secondary|Efficacy and Safety|"Proportion of pts with confirmed virological and treatment failure at w96. Change in CD4 cell counts.~Occurrence of viral resistance to atazanavir in pts with confirmed virologic failure.~Proportion of pts with adverse events, with ≥grade 2 adverse events or abnormal laboratory tests, proportion of pts with side effects leading to discontinuation.~Body fat redistribution and vertebral and femoral bone mineral density. Adherence changes; changes in HIV-associated neurocognitive disorders. Difference in levels of activated Tcells and pro-inflammatory cytokines between treatment groups."|week 96|||||||
2667812|NCT01511809|Primary|Proportion of Patients With Treatment Failure (TF)|Proportion of patients with treatment failure defined as having one of the following events: confirmed viral rebound (CVR) or treatment discontinuation for any cause. CVR was established when 2 consecutive viral load values (HIV-1 RNA)>50 copies/mL occurred within 2 weeks during follow-up. In case of CVR, patients treated with atazanavir/ritonavir monotherapy had to re-introduce their previous 2NRTIs (re-intensification) and, if not suppressed (HIV-1 RNA <50 copies /ml) after 12 weeks, discontinued from the study. Re-intensification was considered as treatment failure in the primary analysis conducted according to the intention-to-treat principle (intention-to-treat analysis with re-intensification equal failure, ITT=Failure) while it was not in the secondary analysis (intention-to-treat analysis with re-intensification equal success, ITT=Success).|Up to week 48||||percentage of patients|||Number
2667813|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Abiraterone : Concentration Observed Just Before Treatment Administration During Repeated Dosing at Steady State (Ctrough ss)||Pre abiraterone dose on Day 1 of Cycle 1|Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.|||ng/mL||Standard Deviation|Mean
2668245|NCT01507831|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
2667814|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Abiraterone : Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC 0-24)|Area under the plasma concentration-time curve calculated using the trapezoidal method from time zero to 24 hours corresponding to abiraterone acetate dosing interval.|0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1|Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.|||ng*h/mL||Standard Deviation|Mean
2667815|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Abiraterone : First Time to Reach Cmax (Tmax)||0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1|Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.|||hour||Full Range|Median
2667816|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Abiraterone : Maximum Plasma Concentration Observed (Cmax)||0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1|Analysis was performed on PK population. One participant was excluded from analysis due to aberrant data.|||ng/mL||Standard Deviation|Mean
2667817|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Volume of Distribution at Steady State (Vss)||5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on PK population.|||L/m^2||Standard Deviation|Mean
2667818|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Total Plasma Clearance (CL)||5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on PK population.|||L/h/m^2||Standard Deviation|Mean
2667819|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Terminal Half-life (t 1/2z)||5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on PK population.|||hour||Standard Deviation|Mean
2667820|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Area Under the Plasma Concentration Versus Time Curve (AUC)|Area under the concentration-time curve calculated using the following equation: AUC = Plasma clearance (CL)/dose|5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on PK population.|||ng*h/mL||Standard Deviation|Mean
2667821|NCT01511536|Secondary|Phase 2: Pharmacokinetic of Cabazitaxel : Maximum Plasma Concentration Observed (Cmax)||5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1|Analysis was performed on pharmacokinetic (PK) population which included all participants who received at least 1 treatment. Pre-dose samples from 3 participants of Phase 2, were above lower limit of quantification (LLOQ) (1.00 ng/mL). Hence, those participants were excluded from analysis.|||ng/mL||Standard Deviation|Mean
2667822|NCT01511536|Secondary|Phase 2: Overall Survival|Overall survival was defined as the time interval from the date of treatment start to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive and the study cut-off date. Analysis was performed by Kaplan-Meier method.|From baseline up to death or study cut-off (maximum duration: 603 days)|Analysis was performed on efficacy/activity population.|||months||95% Confidence Interval|Median
2667823|NCT01511536|Secondary|Phase 2: Percentage of Participants With Objective Response|Objective response was defined as having complete response (CR) or Partial Response (PR) assessed by RECIST 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters).|Baseline, every 12 weeks there after until disease progression (maximum duration: 603 days)|Efficacy/activity population. Number of participants analyzed=participants with measurable disease at baseline.|||percentage of participants||95% Confidence Interval|Number
2667824|NCT01511536|Secondary|Phase 2: PSA Progression Free Survival|"Prostate-specific antigen progression-free survival was defined as the time interval between the date of treatment start and the date of either first documented PSA progression or death due to any cause, whichever was earlier. PSA was to be measured at baseline, every 3 weeks, throughout study period, until progression. PSA progression was defined as: -An increase of 25% above the nadir (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have achieved a ≥50% decline of PSA. -An increase in PSA by 25 % above the baseline level (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have not achieved a ≥50% decline of PSA.~Analysis was performed by Kaplan Meire method."|Baseline, every 3 weeks up to PSA progression (maximum duration: 603 days)|Analysis was performed on efficacy/activity population.|||months||95% Confidence Interval|Median
2667825|NCT01511536|Secondary|Phase 2: Objective Progression Free Survival (PFS)|"Objective PFS was defined as the time interval between the date of enrollment and the first occurrence of any of the events:~1) Radiological tumor progression (assessed using Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) was defined as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. in case of progressive disease (PD) diagnosed only on non target bone lesions on bone scan, PD was to be considered only in case of appearance of at least 2 new lesions on bone scan confirmed 6 weeks later by another bone scan, and at least the appearance of 2 new additional lesions. 2) Death due to any cause.~Analysis was performed by Kaplan-Meier method."|From baseline until radiological tumor or disease progression or death due to any cause, assessed up to Month 5|Analysis was performed on efficacy/activity population.|||months||95% Confidence Interval|Median
2668963|NCT01499810|Secondary|Change in Echocardiographic Left Ventricular Mass||from baseline to 6 months|Number of participants assessed by echocardiography (EchoCG ) at 6 months|||g||Standard Deviation|Mean
2667826|NCT01511536|Primary|Phase 2: Percentage of Participants With Prostate Specific Antigen (PSA) Response|Prostate specific antigen (PSA) response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed at least 3 weeks later. Increases of any magnitude during the first 12 weeks were ignored in determining PSA response. PSA was to be measured at baseline, every 3 weeks, throughout study period, until progression. PSA progression was defined as: -An increase of 25% above the nadir (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have achieved a ≥50% decline of PSA. -An increase in PSA by 25 % above the baseline level (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have not achieved a ≥50% decline of PSA.|Baseline, every 3 weeks up to PSA progression (maximum duration: 603 days)|Analysis was performed on efficacy/activity population included all participants who had received at least 2 cycles of the study drug in Phase 2, and had a baseline and at least one post-baseline assessment for the efficacy variable of interest.|||percentage of participants||95% Confidence Interval|Number
2667827|NCT01511536|Primary|Phase 1: Maximally Tolerated Dose (MTD) of Cabazitaxel in Combination With Abiraterone Acetate|MTD was defined as highest dose level of cabazitaxel in combination with abiraterone acetate at which no more than 1 participant experienced dose limiting toxicities (DLT). DLT was defined as any of the following events related to study treatment: 1) Grade 3 or 4 non-hematological related adverse event with exception of Grade 3 fever without documented infection; Grade 3 nausea, vomiting, or diarrhea in the absence of effective maximal therapy; and Grade 3 hypersensitivity reaction in the absence of required premedication. 2) Hematological toxicity: Febrile neutropenia (fever of unknown origin ≥38.5°C with neutropenia Grade 3 or 4); Neutropenia Grade 4 lasting >7 days; Thrombocytopenia Grade 4 or Grade 3 complicated by hemorrhage. 3) Re-treatment delay of more than 2 weeks due to delayed recovery from a toxicity related to study treatment to baseline or ≤ Grade 1 (except for alopecia). Grades were based on National Cancer Institute CommonTerminology Criteria for Adverse Events v4.03.|Up to Cycle 2 of Phase 1 (up to 42 days)|Analysis was performed on DLT evaluable population defined as all participants who received the first 2 cycles, unless they discontinued the study drug during the first 2 cycles for a DLT.|||mg/m^2|||Number
2667828|NCT01511445|Secondary|Fusion Status|Dynamic flexion-extension plane film x-rays will be used to assess fusion at all four follow-up periods. The criteria for fusion are rotation motion less than or equal to four degrees and translation less than 1.25 mm. The final fusion judgement will be fusion status at 24 months or the last time point with flexion-extension data available.|3 mo., 6mo., 12 mo., 24 months|Patients with 24 month films|||Participants|||Count of Participants
2667829|NCT01511445|Primary|Neck Disability Index|The change in the Neck Disability Index compared to the pre-op value for each group will be compared. Neck disability index is a unitless measure from zero (no disability) to 100 (absolute disability). Change is calculated as the pre-op value minus the 24 month value. A negative difference indicates that the patient is more disabled at 24 months.|24 months post-op|Patients who had data from 24 month follow-up visit|||units on a scale from 0 to 100||Standard Deviation|Mean
2667830|NCT01511419|Other Pre-specified|Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Effector Memory T Cell Responses|"H7N3-specific T cell responses were examined in PBMCs obtained from all the study subjects before vaccination (Day 0), 28 days after the first vaccination (Day 28) and 28 days after revaccination (Day 56). To calculate the frequency of virus-specific T cells we quantified all cells positive for IFNγ after in vitro stimulation with whole H7N3 virion.~Increases in the antigen-specific CD4+T-cell levels exceeding 3 standard deviations from the levels in the mean of the placebo were considered positive responses."|Days 0, 28 & 56|Per-Protocol (PP) population that received 2 doses of either vaccine or placebo|||Participants|||Count of Participants
2667831|NCT01511419|Other Pre-specified|Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Central Memory T Cell Responses|"H7N3-specific T cell responses were examined in PBMCs obtained from all the study subjects before vaccination (Day 0), 28 days after the first vaccination (Day 28) and 28 days after revaccination (Day 56). To calculate the frequency of virus-specific T cells we quantified all cells positive for IFNγ after in vitro stimulation with whole H7N3 virion.~Increases in the antigen-specific CD4+T-cell levels exceeding 3 standard deviations from the levels in the mean of the placebo were considered positive responses."|Days 0, 28 & 56|Per-Protocol (PP) population that received 2 doses of either vaccine or placebo|||Participants|||Count of Participants
2667832|NCT01511419|Other Pre-specified|Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Responses|"H7N3-specific T cell responses were examined in PBMCs obtained from all the study subjects before vaccination (Day 0), 28 days after the first vaccination (Day 28) and 28 days after revaccination (Day 56). To calculate the frequency of virus-specific T cells we quantified all cells positive for IFNγ after in vitro stimulation with whole H7N3 virion.~Increases in the antigen-specific CD4+T-cell levels exceeding 3 standard deviations from the levels in the mean of the placebo were considered positive responses."|Days 0, 28 & 56|Per-Protocol (PP) population that received 2 doses of either vaccine or placebo|||Participants|||Count of Participants
2667833|NCT01511419|Other Pre-specified|Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Effector Memory T Cell Responses|"H7N3-specific T cell responses were examined in PBMCs obtained from all the study subjects before vaccination (Day 0), 28 days after the first vaccination (Day 28) and 28 days after revaccination (Day 56). To calculate the frequency of virus-specific T cells we quantified all cells positive for IFNγ after in vitro stimulation with whole H7N3 virion.~Increases in the antigen-specific CD4+T-cell levels exceeding 3 standard deviations from the levels in the mean of the placebo were considered positive responses."|Days 0, 28 & 56||||Participants|||Count of Participants
2667834|NCT01511419|Other Pre-specified|Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Central Memory T Cell Responses|"H7N3-specific T cell responses were examined in PBMCs obtained from all the study subjects before vaccination (Day 0), 28 days after the first vaccination (Day 28) and 28 days after revaccination (Day 56). To calculate the frequency of virus-specific T cells we quantified all cells positive for IFNγ after in vitro stimulation with whole H7N3 virion.~Increases in the antigen-specific CD4+T-cell levels exceeding 3 standard deviations from the levels in the mean of the placebo were considered positive responses."|Days 0, 28 & 56|Per-Protocol (PP) population that received 2 doses of either vaccine or placebo|||Participants|||Count of Participants
2668964|NCT01499810|Secondary|Change in Mean 24-h Diastolic BP||from baseline to 6 months|Number of participants assessed at 6 months minus 2 participants with unsatisfactory ABPM record|||mmHg||Standard Deviation|Mean
2667835|NCT01511419|Other Pre-specified|Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Responses|"H7N3-specific T cell responses were examined in peripheral blood mononuclear cells (PBMCs) obtained from all the study subjects before vaccination (Day 0), 28 days after the first vaccination (Day 28) and 28 days after revaccination (Day 56). To calculate the frequency of virus-specific T cells we quantified all cells positive for IFNγ after in vitro stimulation with whole H7N3 virion.~Increases in the antigen-specific CD4+T-cell levels exceeding 3 standard deviations from the levels in the mean of the placebo were considered positive responses."|Days 0, 28 & 56|Per-Protocol (PP) population that received 2 doses of either vaccine or placebo|||Participants|||Count of Participants
2667836|NCT01511419|Secondary|Number/Percentage of Subjects Shedding Virus After Second Dose|Detected by real-time reverse transcriptase polymerase chain reaction (rRTPCR) in nasal swabs or conjunctival swabs or by isolation in chicken embryos.|Day 29, 30, 31 and 32|Per‐Protocol (PP) Population|||Participants|||Count of Participants
2667837|NCT01511419|Secondary|Number/Percentage of Vaccinated Subjects Shedding Virus After First Dose|Detected by real-time reverse transcriptase polymerase chain reaction (rRTPCR) in nasal swabs or conjunctival swabs or by isolation in chicken embryos.|Days 1, 2, 3 & 4|Intent-To-Treat (ITT) Population|||Participants|||Count of Participants
2667838|NCT01511419|Secondary|Geometric Mean Titers (GMTs) for Serum Neutralizing Antibodies|Measured by microneutralization assay|0 days, 28 days (Dose 1) and 56 days (Dose 2)|Per-Protocol (PP) population|||titer||95% Confidence Interval|Geometric Mean
2667839|NCT01511419|Secondary|Geometric Mean Titers (GMTs) for Serum Hemagglutination Inhibition (HAI) Antibodies (2 Haemagglutinating Units of H7N3)|HAI test was performed by standard procedure with human red blood cells utilizing 2 haemagglutinating units (HAU) of H7N3.|0 days, 28 days (Dose 1) and 56 days (Dose 2)|Per-Protocol (PP) population|||titer||95% Confidence Interval|Geometric Mean
2667840|NCT01511419|Secondary|Geometric Mean Titers (GMTs) for Serum Hemagglutination Inhibition (HAI) Antibodies (4 Haemagglutinating Units of H7N3)|HAI test was performed by standard procedure with human red blood cells utilizing either 4 haemagglutinating units (HAU) of H7N3.|0 days, 28 days (Dose 1) and 56 days (Dose 2)|Per-Protocol (PP) Population|||titers||95% Confidence Interval|Geometric Mean
2667841|NCT01511419|Secondary|Number/Percentage of Subjects With Seroconversion for Mucosal IgA|From nasal wick specimen. Seroconversion was defined as at least a four-fold rise after each dose from baseline or as the mean titer after each dose|28 days (Dose 1) and 56 days (Dose 2)|Per-Protocol (PP) Population|||Participants|||Count of Participants
2667842|NCT01511419|Secondary|Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin G (IgG)|Measured by enzyme-linked immunoassay (EIA). Seroconversion was defined as at least a four-fold rise after each dose from baseline or as the mean titer after each dose|28 days (Dose 1) and 56 days (Dose 2)|Per-Protocol (PP) Population|||Participants|||Count of Participants
2667843|NCT01511419|Secondary|Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin A (IgA)|Measured by enzyme-linked immunoassay (EIA). Seroconversion was defined as at least a four-fold rise after each dose from baseline or as the mean titer after each dose|28 days (Dose 1) and 56 days (Dose 2)|Per-Protocol (PP) Population|||Participants|||Count of Participants
2667844|NCT01511419|Secondary|Number/Percentage of Subjects With Serum Neutralizing Antibodies|Measured using microneutralization assay. Seroconversion was defined as at least a four-fold rise after each dose from baseline or as the mean titer after each dose|28 days (Dose 1) and 56 days (Dose 2)|Per-Protocol (PP) Population|||Participants|||Count of Participants
2667845|NCT01511419|Secondary|Number/Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI)|Seroconversion was defined as at least a four-fold rise after each dose from baseline or as the mean titer after each dose|28 days (Dose 1) and 56 days (Dose 2)|Per-Protocol (PP) Population|||Participants|||Count of Participants
2667846|NCT01511419|Primary|Participants With Serious Adverse Events (SAEs)|Including abnormal laboratory findings|Within 4 weeks of receipt of any dose|Intent‐To‐Treat (ITT) Population|||Participants|||Count of Participants
2667847|NCT01511419|Primary|All Other Adverse Events|Including unsolicited events and abnormal laboratory findings|7 days following any dose|Total events among Intent‐To‐Treat (ITT) Population|||adverse events|adverse events||Count of Units
2667848|NCT01511419|Primary|Adverse Events Associated With Intranasal Vaccination|From solicited local and systemic reactions|Greater than 2 hours through 7 days following any dose|Intent‐To‐Treat (ITT) Population|||Participants|||Count of Participants
2667849|NCT01511419|Primary|Number of Participants With Immediate Reactions|From administration of any dose, immediate reaction measured as observed by study staff or reported by the subject to study staff in case of an anaphylactic reaction.|2 hours post-administration on Days 0 and 28|Intent-to-treat (ITT) population|||Participants|||Count of Participants
2667850|NCT01511315|Secondary|Percentage of Patients Achieving PASI-75 at Weeks 12, 24, and 36|The Psoriasis Area and Severity Index (PASI) incorporates erythema, induration, and scale on a score of 0-4 weighted by percentage of body surface area involvement. PASI scores range from 0 to 72, with higher scores indicating worse disease. The percentage of patients achieving 75% reduction or better from the baseline PASI score in a designated time period has become the gold standard to measure the efficacy of psoriasis treatment options.|Weeks 12, 24, and 36|Only participants who completed the study were included in this analysis (n=32).|||percentage of participants|||Number
2667851|NCT01511315|Secondary|Percentage of Patients Achieving PGA of Clear or Almost Clear at Weeks 12, 24, and 36|The Physician Global Assessment (PGA) scoring system is used to assess the severity and extent of psoriasis using a score of 0-6 (clear, almost clear, minimal, moderate, severe, to very severe) averaged over all lesions.|Weeks 12, 24, and 36|Only participants who completed the study were included in this analysis (n=32).|||percentage of participants|||Number
2667852|NCT01511315|Secondary|Change in Dermatology Life Quality Index (DLQI) Over Time (at Weeks 12, 24, and 36) From Baseline|The DLQI is a 10-item self-reported survey, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question item is worth 3 points (total maximum score of 30), with higher score representing greater QoL impairment.|Baseline, 12, 24, and 36 Weeks|Only participants who completed the study were included in this analysis (n=32).|||units on a scale||Standard Error|Mean
2668965|NCT01499810|Secondary|Change in Mean 24-h Systolic BP||from baseline to 6 months|Number of participants assessed at 6 months minus 2 participants with unsatisfactory ABPM records|||mmHg||Standard Deviation|Mean
2667853|NCT01511315|Secondary|Change in Psoriasis Quality of Life - 12 Items (PQOL-12) Over Time (at Weeks 12, 24, and 36) From Baseline|The PQOL-12 is a 12-item psoriasis-specific validated PRO based entirely on the patient's own assessment of their situation. The items were data-derived based on a series of population-based statistical studies and clinical trials conducted over a decade. The KMPI is one of the first tools used in dermatology to incorporate a validated PRO in critical medical decision-making. The scores range from 0-120 with higher scores indicating worse outcomes.|Baseline, 12, 24, and 36 Weeks|Only participants who completed the study were included in this analysis (n=32).|||units on a scale||Standard Error|Mean
2667854|NCT01511315|Secondary|Change in Work Productivity and Activity Impairment Scale (WPAI-PSO) Over Time at Week 36 From Baseline|The WPAI is a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to general health or a specific health problem. The WPAI:PSO was created specifically for administering to patients with psoriasis. WPAI surveys were analyzed based on published algorithms to determine the following: current employment status, absenteeism (percentage of time missed from work due to psoriasis), presenteeism (percentage reduced productivity at work due to psoriasis), total activity impairment (TAI, percentage impairment in activities other than work due to psoriasis), and total work productivity impairment (TWPI, total percentage of work impairment from both absenteeism and presenteeism due to psoriasis). Each WPAI score is expressed as impairment percentages (0-100), with higher scores representing greater impairment (worse outcomes)|Baseline, 36 Weeks|Only participants who completed the study were included in this analysis (n=32).|||units on a scale||Standard Deviation|Mean
2667855|NCT01511315|Secondary|Change in Psychological General Well-Being Scale (PGWB) Over Time (at Weeks 12 and 24) From Baseline|The PGWB is a self-administered validated psychometric instrument that measures a person's emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.|Baseline, 12 and 24 weeks|Only participants who completed the study were included in this analysis (n=32).|||units on a scale||Standard Error|Mean
2667856|NCT01511315|Primary|Improvement in Quality of Life Measured by Change in Psychological General Well-Being Scale (PGWB) at Week 36 From Baseline.|The PGWB is a self-administered validated psychometric instrument that measures a person's emotional well-being. It is specifically designed to be suitable for assessing psychological well being in the general medical population as opposed to a psychiatric population. The 22 questions of the PGWB can be further divided into 6 domains: anxiety, depressed mood, positive well being, self-control, general health, and vitality. The PGWB is graded on a Likert scale, which is commonly used in psychometric questionnaires where the answers range from strongly agree to strongly disagree with gradations in between. Total scores range from 0 to 110, with higher scores indicating better psychological well being. This instrument has been validated and used in many countries on large samples of the general population and on various subsets of medical patients.|Baseline, 36 weeks|Only participants who completed the study were included in this analysis (n=32).|||units on a scale||Standard Error|Mean
2667857|NCT01511250|Secondary|Number of Participants With Confirmed Dengue Fever|Dengue fever was assessed in participants who had 3 consecutive days of fever >38°C and tested positive for dengue virus by polymerase chain reaction (PCR) analysis.|Day 1 to Day 1080|The safety set included all randomized participants who received at least one dose of study vaccine (or placebo).|||participants|||Number
2667858|NCT01511250|Secondary|Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes||Day 28 and Day 90 (Parts 1 and 2) and Days 120, 180, 360, 720 and 1080 in Part 1|FAS included all randomized participants who received at least one dose of study vaccine or placebo and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received.|||fold rise||95% Confidence Interval|Geometric Mean
2667859|NCT01511250|Secondary|Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes|GMTs were assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3, and TDV-4.|Day 28, 90 and 120 (Parts 1 and 2) and Days 180, 360, 720 and 1080 in Part 1|"The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received. Here n is the number of participants with microneutralizing (MN) assay samples."|||titer||95% Confidence Interval|Mean
2667860|NCT01511250|Secondary|Seroconversion Rate to Each of the Four Dengue Serotypes|Seroconversion rate was defined as the percentage of participants with microneutralization test 50% (MNT50) titer ≥10 or, if the titer on Day 0 was ≥10, a 4-fold rise in antibody titer.|Day 28, 90 and 120 (Parts 1 and 2) and Days 180, 360, 720 and 1080 in Part 1|FAS included all randomized participants who received at least one dose of study vaccine or placebo and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received.|||percentage of participants||95% Confidence Interval|Number
2667861|NCT01511250|Secondary|Seropositivity Rate to Each of the Four Dengue Serotypes|Seropositivity rate, defined as the percentage of participants seropositive, was derived from titers of dengue-neutralizing antibodies. Participants were classified by titer after Day 0 as seropositive or seronegative. Seropositive was defined as a MNT50 titre value of ≥10 and seronegative was defined as titre value of less than (<) 10. Seropositivity was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3, TDV-4.|Day 28 and Day 90 (Parts 1 and 2) and Days 180, 360, 720 and 1080 in Part 1|FAS included all randomized participants who received at least one dose of study vaccine or placebo and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received.|||percentage of participants||95% Confidence Interval|Number
2667862|NCT01511250|Secondary|Part I: Titers of Vaccine Viremia||Days 0, 7, 14, 90, 97, and 104|Due to the very low prevalence of vaccine viremia, there was insufficient data for the estimation of average titer duration of viral RNA within study groups.||||||
2667863|NCT01511250|Secondary|Part I: Duration of Vaccine Viremia||Days 0, 7, 14, 90, 97, and 104|Due to the very low prevalence of vaccine viremia, there was insufficient data for the estimation of average titer duration of viral RNA within study groups.||||||
2667864|NCT01511250|Secondary|Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination|Vaccine viremia was assessed for each of the four vaccine strain serotypes: TDV-1, TDV-2, TDV-3 and TDV-4 for Part-1. Vaccine viral ribonucleic acid (RNA) was detected by a quantitative reverse transcription-polymerase chain reaction (qRT-PCR) assay.|Days 0, 7, 14, 90, 97, and 104|The FAS included all randomized participants who received at least one dose of study vaccine and for whom valid pre-dosing and at least one valid post-dosing blood sample have been received.|||participants|||Number
2667865|NCT01511250|Primary|Seropositivity Rate to Each of the Four Dengue Serotypes at Day 120|Seropositivity rate, defined as the percentage of participants seropositive, was derived from titers of dengue-neutralizing antibodies. Participants were classified by titer after Day 0 as seropositive or seronegative. Seropositive was defined as a MNT50 titre value of ≥10 for any serotype and seronegative was defined as titre value of less than (<) 10 for all 4 serotypes. Seropositivity was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3, TDV-4.|30 days after second vaccination (Day 120)|FAS included all randomized participants who received at least one dose of study vaccine or placebo and for whom valid pre-dosing and at least one valid post-dosing blood sample has been received.|||percentage of participants||95% Confidence Interval|Number
2667866|NCT01511250|Primary|Number of Participants With at Least One Unsolicited AE Following Either Vaccination Dose by Severity|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The severity of all unsolicited AEs was evaluated by the Investigator (using the Common Terminology Criteria for Adverse Events [CTCAE] v4.03) as follows. Mild (Grade 1): Transient symptoms, discomfort noticed but was easily tolerated by the participant with no interference to normal daily activities. Moderate (Grade 2): Marked symptoms, moderate interference with participant's daily activities. Severe (Grade 3): Considerable interference with participant's daily activities.|Unsolicited AEs were collected within 28 days of all vaccinations. Serious AEs were collected throughout the study up to Day 1080|The safety set included all randomized participants who received at least one dose of study vaccine (or placebo).|||participants|||Number
2667867|NCT01511250|Primary|Number of Participants With Any Solicited AE Following Either Vaccination Dose|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited local injection site reactions included pain, itching, erythema, edema and solicited systemic AEs include myalgia, arthralgia, eye pain, photophobia, fatigue, body rash, nausea, vomiting, and fever.|Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)|The safety set included all randomized participants who received at least one dose of study vaccine (or placebo).|||participants|||Number
2667868|NCT01511250|Primary|Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity|Solicited systemic AEs (headache, muscle pain [myalgia], joint pain [arthralgia], eye pain, sensitivity to light [photophobia], tiredness [fatigue], body rash, nausea, were recorded in the participant's-diary along with vomiting [number of times]), and body temperature). Diary-recorded severity grades were based on the Common Terminology Criteria for Adverse Events (CTCAE). Severity grades were: Mild (Grade 1): transient symptoms, discomfort noticed but was easily tolerated by the participant with no interference to normal daily activities. Moderate (Grade 2): marked symptoms, moderate interference with participant's daily activities. Severe (Grade 3): Considerable interference with participant's daily activities. The CTCAE severity grades for fever and vomiting were derived from the diary-recorded measurements of temperature level and number of episodes, respectively.|Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)|The safety set included all randomized participants who received at least one dose of study vaccine (or placebo). Only categories for which there was at least 1 participant are reported.|||participants|||Number
2667869|NCT01511250|Primary|Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (In Clinic Assessment) Following Either Vaccination Dose by Severity|Solicited local injection site reactions were collected by subject diary and graded based on the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 for pain [Grade 0 (no pain), 1 (mild), 2 (moderate) and 3 (severe)] and itching (pruritus) [Grade 0 (no itching), 1 (mild), 2 (moderate) and 3 (Severe]. Severity grade for redness (erythema) and swelling (edema/induration) were derived from recorded length of the longest diameter measurement using the FDA Guidance for Industry: Toxicity Grading Scale of Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial were Grade 0 (<2.5 cm), 1 (mild: 2.5-5 cm), 2 (moderate: 5.1-10 cm) and 3 (severe: >10 cm) and Grade 4 (Potentially Life-threatening: necrosis or exfoliative dermatitis).|Within 28 days after either of the vaccination given on Day 0 or 90 (Day 28 for first vaccination, Day 118 for second vaccination)|The safety set included all randomized participants who received at least one dose of study vaccine (or placebo). Only categories for which there was at least 1 participant are reported.|||participants|||Number
2667870|NCT01511250|Primary|Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity|Solicited local injection site reactions were collected by subject diary and graded based on the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 for pain [Grade 0 (no pain), 1 (mild), 2 (moderate) and 3 (severe)] and itching (pruritus) [Grade 0 (no itching), 1 (mild), 2 (moderate) and 3 (Severe]. Severity grade for redness (erythema) and swelling (edema/induration) were derived from recorded length of the longest diameter measurement using the FDA Guidance for Industry: Toxicity Grading Scale of Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial were Grade 0 (<2.5 cm), 1 (mild: 2.5-5 cm), 2 (moderate: 5.1-10 cm) and 3 (severe: >10 cm) and Grade 4 (Potentially Life-threatening: necrosis or exfoliative dermatitis).|Within 14 days after either of the vaccination given on Day 0 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)|The safety set included all randomized participants who received at least one dose of study vaccine (or placebo). Only categories for which there was at least 1 participant are reported.|||participants|||Number
2668320|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Intercept)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the intercept of the regression equation comparing observed vs. predicted weight.|study day 1|Final population for data analysis.|||kilograms||95% Confidence Interval|Number
2667872|NCT01511107|Secondary|The Distribution of Children for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product|Protocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product.|Day 1 of administration of study product until day 16 for all episodes|The analysis was ITT. The number of participants equals the number of children randomized and eligible.|||participants|||Number
2667873|NCT01511107|Secondary|The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Scores Days 6 to 14|"The AOM-SOS scale measures seven discrete items: tugging of ears, crying, irritability, difficulty sleeping, diminished activity, diminished appetite, and fever. The parent rated each of these symptoms in comparison with the child's usual state, as none, a little, or a lot, with corresponding scores of 0, 1, and 2, and recorded the ratings in a diary. Each set of ratings was summed to obtain an AOM-SOS score as a measure of symptom burden. Total scores range from 0 to 14, with higher scores indicating greater severity of symptoms. For instances in which the participant was declared a treatment failure, scores are included up to, but not including the day of the failure. Otherwise, scores day 6 to day 14 are included."|From day 6 of administration of study product until day 14 for all episodes|The analysis was ITT. The number of participants equals the number of children with at least one AOM-SOS score from day 6 of administration of study product to day 14. The scores were based on diaries completed at home by the child's parent.|||AOM-SOS score||Standard Deviation|Mean
2667874|NCT01511107|Secondary|The Mean Number of Days Systemic Antibiotics Were Received During the Entire Respiratory Season|Systemic antibiotics include the study product, Amoxicillin-Clavulanate, dispensed for either 10 or 5 days and various concomitant medications, i.e. Amoxicillin, Amox/Clav, Azithromycin, Cefdinir, Cefpodoxime, Ceftriaxone, Erythromycin, Trimethoprim-Sulfamethoxazole, Omnicef, Augmentin, Azithromycin, Cefazolin, Clarythromycin and Ciprofloxacin.|Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible.|||days||Standard Deviation|Mean
2667875|NCT01511107|Secondary|The Mean Rate, Per Month, of Protocol AOM Recurrences and Relapses Within the Entire Respiratory Season|"An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.~The rate, expressed as a monthly rate, is calculated by dividing the total number of recurrences and relapses by the number of months of follow-up."|Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.|The analysis was ITT. The participants are randomized & eligible children having follow-up beyond day 16.|||recurrences/relapses per months followed||Standard Deviation|Mean
2667876|NCT01511107|Secondary|The Mean Rate, Per Month, of Protocol AOM Recurrences and Relapses Within 60 Days of Enrollment|"An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.~The rate, expressed as a monthly rate, is calculated by dividing the total number of recurrences and relapses within 60 days of enrollment by the number of months of follow-up within 60 days of enrollment."|Day 1 of study entry until day 60.|The analysis was ITT. The participants are randomized & eligible children having follow-up beyond day 16.|||recurrences/relapses per month||Standard Deviation|Mean
2667877|NCT01511107|Secondary|The Distribution of Children With AOM Recurrences and Relapses Within the Entire Respiratory Season|An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.|Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.|The analysis was ITT. The participants are randomized & eligible children completing the study.|||participants|||Number
2667878|NCT01511107|Secondary|The Distribution of Children With AOM Recurrences and Relapses Within 60 Days of Enrollment|An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.|Day 1 of study entry until day 60.|The analysis was ITT. The participants are randomized & eligible children having follow-up greater than or equal to day 60.|||participants|||Number
2667879|NCT01511107|Secondary|The Distribution of AOM Recurrences for Which the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit Yields a Nonsusceptible Haemophilus Influenzae (H Flu) Isolate|In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit following a recurrence. The mean day for this visit was 13.6.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following an AOM recurrence.|||recurrence|Recurrences||Number
2667880|NCT01511107|Secondary|The Distribution of Children for Whom the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit, Specific to the Index Episode, Yields a Nonsusceptible Haemophilus Influenzae (H Flu) Isolate|In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit specific to the index episode. The mean day for this visit was 13.4.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following the index episode.|||participants|||Number
2667950|NCT01510327|Secondary|Area Under the Concentration Versus Time Curve (AUC 0-t) Everolimus|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent; t is the last time at which concentration can be quantified|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|The analysis groups reported here had 3 or more subjects.|||ng*hr/mL||Standard Deviation|Mean
2668966|NCT01499810|Secondary|Change in Office Diastolic BP||from baseline to 6 month||||mmHg||Standard Error|Mean
2667881|NCT01511107|Secondary|The Distribution of AOM Recurrences for Which the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit Yields a Nonsusceptible Streptococcus Pneumoniae (S pn) Isolate|In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm.|The day 12-14 visit following a recurrence. The mean day for this visit was 13.6.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following an AOM recurrence.|||recurrence|Recurrences||Number
2667882|NCT01511107|Secondary|The Distribution of Children for Whom the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit, Specific to the Index Episode, Yields a Nonsusceptible Streptococcus Pneumoniae (S pn) Isolate|In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm.|The day 12-14 visit specific to the index episode. The mean day for this visit was 13.4.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible having a NP culture at the day 12-14 visit following the index episode.|||participants|||Number
2667883|NCT01511107|Secondary|The Distribution of 6 Week Follow-up, Non-Illness Visits During the Respiratory Season at Which a Nonsusceptible Pathogen is Recovered|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.|The analysis was ITT. The participants are randomized & eligible children with at least one follow-up, nonillness visit, with a nasopharyngeal (NP) culture which is either positive (+) for >=1 penicillin nonsusceptible pathogens or positive (+) only for >=1 penicillin susceptible pathogens or pathogen negative (-).|||Visit|Visits||Number
2667884|NCT01511107|Secondary|The Distribution of Children Whose Nasopharyngeal (NP) Isolates at Enrollment Are Pathogen Negative or Positive Only for at Least One Susceptible Pathogen Who Become Colonized With Nonsusceptible Pathogens at Any Time Over the Course of Follow-up|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|Day 1 of study entry until day 365|The analysis was ITT. The participants are randomized & eligible children having both a NP culture at enrollment that is either pathogen negative or positive only for >=1 susceptible pathogen and a NP culture at some time over the course of followup.|||participants|||Number
2667885|NCT01511107|Secondary|The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Positive for One or More Nonsusceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The end-of-treatment visit. The mean day for this visit was 13.4.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at onset that is positive (+) for >=1 nonsusceptible pathogen & a NP culture at the day 12-14 visit which is either + for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.|||recurrence|Recurrences||Number
2667886|NCT01511107|Secondary|The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Positive for One or More Nonsusceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The end-of-treatment visit. The mean day for this visit was 13.6.|The analysis was ITT. The participants are randomized & eligible children having both a NP culture at enrollment that is positive (+) for one or more nonsusceptible pathogens & a NP culture at the day 12-14 visit which is either + for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.|||participants|||Number
2668321|NCT01507090|Secondary|Inter-rater Reliability for the 2D and 3D Mercy TAPEs.|Intraclass correlation coefficient|study day 1|All pre-qualified study coordinators|||Intraclass correlation coefficient|||Number
2668967|NCT01499810|Secondary|Change in Office Systolic BP||from baseline to 6 month||||mmHg||Standard Deviation|Mean
2667887|NCT01511107|Secondary|The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Positive Only for One or More Susceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit. The mean day for this visit was 13.9.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at onset that is positive (+) only for one or more susceptible pathogens & a NP culture at the day 12-14 visit which is either + for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.|||recurrence|Recurrences||Number
2667888|NCT01511107|Secondary|The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Positive Only for One or More Susceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit. The mean day for this visit was 13.2.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at enrollment that is positive only for >=1 susceptible pathogen & a NP culture at the day 12-14 visit which is either positive (+) for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.|||participants|||Number
2667889|NCT01511107|Secondary|The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Negative for AOM Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit. The mean day for this visit was 13.4.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at onset that is negative for both S pn and H flu and a NP culture at the day 12-14 visit which is either positive (+) for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.|||recurrence|Recurrences||Number
2667890|NCT01511107|Secondary|The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Negative for AOM Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen|AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL.|The day 12-14 visit. The mean day for this visit was 13.3.|The analysis was ITT. The participants are randomized & eligible children having a NP culture at enrollment that is negative for both S pn and H flu and a NP culture at the day 12-14 visit which is either positive (+) for >=1 penicillin nonsusceptible pathogen OR pathogen negative (-) or + only for >=1 penicillin susceptible pathogen.|||participants|||Number
2667891|NCT01511107|Secondary|The Distribution of AOM Recurrences Categorized as Treatment Failure (TF) at or Before the Day 12-14 End-of-Treatment Visit|"Proportion of AOM recurrences resulting in treatment failure at or before the day 12-14 visit.~TF is defined as substantial persistence or worsening of symptoms specifically attributable to AOM, or of otoscopic signs of AOM, after 72 hours from the time of the recurrence, such that additional antimicrobial therapy is deemed advisable. If a parent/legal guardian is unwilling to continue the assigned study product regimen, the participant will be categorized as TF. Should a participant be administered another systemic antibiotic while taking study medication or prior to Day 16, the participant will be considered a TF. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the TM or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable."|From 72 hours after the AOM recurrence was diagnosed until day 21 of the recurrence. The mean day for this visit was 13.3.|The analysis was ITT. The number of participants is equal to the number of children randomized & eligible who had a clinical assessment at or before the day 12-14 visit following an AOM recurrence.|||recurrence|Recurrences||Number
2667951|NCT01510327|Primary|Maximum Observed Everolimus Blood Concentration (Cmax)|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|The analysis groups reported here had 3 or more subjects.|||ng/mL||Standard Deviation|Mean
2667952|NCT01510158|Secondary|Tophus|Proportion of subjects with ≥ 1 target tophus at Baseline who experience complete resolution of at least 1 target tophus by Month 12|12 Months||||Proportion of Subjects|||Number
2667892|NCT01511107|Primary|The Distribution of Children Categorized as Treatment Failure (TF) at or Before the Day 12-14 End-of-Treatment Visit Specific to the Index Episode of AOM|"Proportion of children initially diagnosed with AOM who experience treatment failure at or before the day 12-14 visit.~TF is defined as substantial persistence or worsening of symptoms specifically attributable to AOM, or of otoscopic signs of AOM, after 72 hours from the time of randomization, such that additional antimicrobial therapy is deemed advisable. If a parent/legal guardian is unwilling to continue the assigned study product regimen, the participant will be categorized as TF. Should a participant be administered another systemic antibiotic while taking study medication or prior to Day 16, the participant will be considered a TF. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the tympanic membrane (TM) or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable."|From 72 hours after randomization until day 21 of the index episode. The mean day for this visit was 13.2.|The analysis was intent to treat (ITT). The number of participants is equal to the number of children randomized & eligible who had a clinical assessment at or before the day 12-14 visit.|||participants|||Number
2667893|NCT01511081|Secondary|Treatment Response|Prospective assessment of positron emission tomography (PET) standardized uptake value (SUV) changes as a measure of treatment response and outcomes. Pulmonary function changes as a function of treatment and response.|2 years|Early study termination. Inadequate enrollment and study period to complete analysis per protocol.||||||
2667894|NCT01511081|Primary|Summary of 2-Year Stereotactic Body Radiotherapy (SBRT) and Stereotactic Body Proton Therapy (SBPT) Related Toxicities by Grade 3+ Treatment-related Toxicity|Outcome defined as 2-year rate of stereotactic body radiotherapy (SBRT)- and SBPT-related toxicities according to Common Terminology Criteria for Adverse Events (CTCAE) v.4 criteria, including: radiation-induced pneumonitis/fibrosis/fistula, esophagitis/stricture/fistula.|2 years|Early study termination. Inadequate enrollment and study period to complete analysis per protocol.||||||
2667895|NCT01511016|Primary|Rate of Net Lipolysis|Rate of net lipolysis was measured in plasma samples by mass spectrometry following stable isotope infusions of labeled glycerol and palmitate|4 months after treatment|Subjects in each group were analyzed and compared after 4 months of treatment|||mmol FFA/kg/h||Standard Error|Mean
2667896|NCT01511016|Secondary|Insulin Levels After Oral Glucose Challenge.|An oral glucose tolerance test was performed to measure endogenous insulin response. This is not PD/PK in the sense that we are not studying the distribution or clearance of a drug. Rather, we are performing a clinical test of endogenous insulin response to glucose i.e., an endocrine test. Although multiple time points are used in this test, the outcome is a single value, i.e., an area-under-the-curve for insulin.|4 months after treatment.|Number of subjects remaining after 4 months of treatment.|||microU/mL||Standard Error|Mean
2667897|NCT01511016|Secondary|Glucose Levels After Glucose Challenge|An oral glucose tolerance test was performed. This is not PD/PK in the sense that we are not studying the distribution or clearance of a drug. Rather, we are performing a standard clinical test of glucose tolerance. i.e., a test for diabetes and pre-diabetes. Although multiple time points are used in this test, the outcome is a single value, either a blood glucose level after 2 hours or an area-under-the-curve. In this study we are reporting the area-under-the-curve.|4 months after treatment.|Number of subjects remaining after 4 months of treatment.|||mg/dL||Standard Error|Mean
2667898|NCT01511016|Secondary|Fasting Plasma Non-HDL-C|Fasting plasma non-HDL-cholesterol was calculated from measured total cholesterol and HDL cholesterol.|4 months after treatment.|Number of subjects in each group remaining after 4 months of treatment.|||mg/dL||Standard Error|Mean
2667899|NCT01511016|Secondary|Rates of Fatty Acid Oxidation|Rates of fatty acid oxidation were measured in breath samples following stable isotope infusions of 13C-labeled palmitate.|4 months after treatment|Number of subjects in each group remaining at the end of 4 months of treatment.|||mmol FFA/kg/h||Standard Error|Mean
2667900|NCT01511016|Primary|Rate of Total Lipolysis|Rate of total lipolysis was measured in plasma samples by mass spectrometry following stable isotope infusions of labeled glycerol and palmitate|4 months after treatment|Subjects in each group were analyzed and compared after 4 months of treatment.|||mmol FFA/kg/h||Standard Error|Mean
2667901|NCT01510912|Other Pre-specified|Mean Short Form-36 Mental Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET|The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The mental component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability.|Baseline to Week 52/Early Termination||||units on a scale||Standard Deviation|Mean
2667902|NCT01510912|Other Pre-specified|Mean Short Form-36 Physical Component Summary Scores at Week 52/Early Termination (ET) and Change From Baseline to Week 52/ET|The Short Form-36 is a validated 11-item health survey that assesses subject views about his/her functional health and well-being. The survey consists of 36 questions concerning daily or recent health-related activities and assesses 8 health domains using scaled scores. The physical component score is composed of a subset of the 8 health domains. Each scale is directly transformed into a 0 to 100 scale on the assumption that each question carries equal weight. A score of 0 is equal to maximum disability, and a score of 100 is equivalent to no disability.|Baseline to Week 52/Early Termination||||units on a scale||Standard Deviation|Mean
2667903|NCT01510912|Primary|Safety of Diclofenac 35 mg Capsules as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination|The safety of Diclofenac 35 mg capsules was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, and serious adverse events.|Baseline to Week 52/Early Termination||||participants|||Number
2667953|NCT01510158|Secondary|Gout Flares|Mean rate of gout flares requiring treatment for the 6-month period from the end of Month 6 to the end of Month 12|12 Months||||Gout Flares||Standard Deviation|Mean
2667954|NCT01510158|Primary|Proportion of Subjects With an sUA Level That is < 6.0 mg/dL||6 Months, analysis after all subjects complete 12 months|Intent-to-Treat Population|||Proportion of Subjects|||Number
2667904|NCT01510834|Secondary|Change in PHQ-8 From T1-T3 (Patient Health Questionnaire [PHQ-8], Kroenke & Spitzer, 2002; Spitzer, Kroenke, & Williams, 1999)|The PHQ-9 is the self-administered depression module of the Patient Health Questionnaire that assesses common mental disorders. Eight of the 9 items in the scale are included in the Depression Prevention Assessment and is also known as the PHQ-8. Item 9, which assesses suicidality has been omitted in the online version. The PHQ-8 has been shown to have a sensitivity of 81% and specificity of 99% for scores 15 and above in diagnosing major depression, with a positive predictive value of 94%. Scores range from 0 to 24 (0-3 points per question multiplied by 8 questions), with 0-9 indicating no depression, 10-14 minor depression, 15-19 moderately severe major depression, and >19 indicating sever major depression. An initial drop of 5 points is considered adequate treatment response for 3 counseling sessions over 4-6 weeks. A higher score indicates more depression, so a reduction in score from baseline (T1) to 3-month follow-up (T3) is a better outcome.|Change in PHQ-8 score from baseline (T1) to final 3 mos. follow-up (T3)|Those participants who completed all 3 time points.|||units on a scale||Standard Deviation|Mean
2667905|NCT01510834|Secondary|Change in PSS From T1 to T3 (The Perceived Stress Scale [PSS] Cohen, Kamarck, & Mermelstein, 1983)|The PSS is the most widely used psychological instrument for measuring the perception of stress. It is a 10-item questionnaire that measures an individual's subjective evaluation the stressfulness of situations in their life in the past month. Items are designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The items are of a general nature and relatively free of content specific to any subpopulation. Internal consistency reliability of the PSS has been shown to be moderate (Cronbach alpha coefficient =.78) and that it has good test-re-test reliability. Scores can range from 0-40 as items are scored 0-4 points each. A higher score indicates more stress, so a negative change from baseline (T1)to 3-month follow-up (T3) is a better outcome.|Change in PSS score from baseline (T1) to final 3 mos. follow-up (T3)|All participants completing all 3 time points of the study.|||units on a scale||Standard Deviation|Mean
2667906|NCT01510834|Secondary|Change in QOLS Score T1 to T3 (Quality of Life Scale [QOLS], Flanagan, 1978, 1982)|"The QOLS contains 16 items that represent five conceptual domains of quality of life. QOLS was developed with more consideration to cultural diversity and individual perspectives than other commonly used measures. It uses a unique 7-item Likert scale that allows responses regarding different aspects of life to range from delightful to terrible. It has been found to be internally consistent with alpha from .82 to .92 and showed high test-retest reliability over 3-weeks (r = 0.78 to r = 0 .84). The QOLS is scored by adding up the score on each item to yield a total score for the instrument. Scores can range from 16 to 112. Previous validation research showed that patients who participated in a treatment program and rated their symptoms as improved by 60% or gained on average 7 to 8 points on the QOLS total score. A higher QOLS score indicates better quality of life, therefore, a positive score change is a better outcome."|Change in QOLS score from baseline (T1) to final 3 mos. follow-up (T3)|Participants completing all 3 study time points.|||units on a scale||Standard Deviation|Mean
2667907|NCT01510834|Primary|Change in PCL-M Score (PTSD Symptom Checklist-Military [PCL-M], Weathers et al., 1993)|Developed by researchers at the VA National Center for PTSD, PCL is a self-report questionnaire that consists of 17 questions that map directly onto DSM-IV criteria for PTSD. Respondents are asked how often they have been bothered by each symptom in the past month on a 5-point Likert scale (1=not at all to 5=extremely). Previous research has shown internal consistency coefficients were high for the total scale (.97) and for each subscale (.92 - .93). Test-retest reliability over 2-3 days was shown to be .96. Scores can range from 17-85, with a score of 48 typically indicating PTSD in military populations. The National Center for PTSD recommends using 5 points as a minimum threshold for determining whether an individual has responded to treatment and 10 points as a minimum threshold for determining whether the improvement is clinically meaningful. A higher score indicates more PTSD symptoms, therefore, a score reduction from T1 to T3 is a better outcome than an increase.|Change in PCL-M score from baseline (T1) to final 3 mos. follow-up (T3)|57 completing all time points for intervention and assessment.|||units on a scale||Standard Deviation|Mean
2667908|NCT01510769|Secondary|Quality of Life|Proportion of subjects with an improvement from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at least 0.25 at Month 12. The HAQ-DI assesses a patient's level of functional ability with items scores ranging from 0-3 with 0 being the least disability.|12 Months|Intent-to-Treat Population|||Proportion of Subjects|||Number
2667909|NCT01510769|Secondary|Complete or Partial Response of at Least One Tophus|Proportion of subjects with a best tophus response on at least 1 target tophus of complete (disappearance of at least 1 target tophus) or partial (≥ 50% decrease in the area of at least 1 target tophus) resolution by Month 12|12 Months|Intent-to-Treat Population|||Proportion of Subjects|||Number
2667910|NCT01510769|Secondary|Complete Resolution of at Least One Target Tophus|Proportion of subjects who experience complete resolution of at least 1 target tophus by Month 12|12 Months|Intent-to-Treat Population|||Proportion of Subjects|||Number
2667911|NCT01510769|Primary|Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6|Proportion of subjects with an sUA level that is < 5.0 mg/dL by Month 6|6 months, analysis after all subjects complete 12 months|Intent-to-Treat Population|||Proportion of Subjects|||Number
2667912|NCT01510756|Secondary|Safety and Tolerability|Frequency, severity and relatedness of adverse events|3 months|zero participants analyzed due to termination of study||||||
2667913|NCT01510756|Secondary|To Determine the iwCLL-WG Defined Overall Response Rate (ORR) - Complete Response (CR) and Partial Responses (PR) to 3 Cycles of Sorafenib Therapy and Following the Completion of All Therapy.|A response assessment must be performed 2 months following completion of therapy to document responses, including a bone marrow if in clinical response (CR) and a computed tomography (or magnetic resonance imaging scan [MRI]) if initial imaging was abnormal or physical examination inconclusive.|Two months following completion of treatment with sorafenib according to iwCLL guidelines.|zero participants analyzed due to termination of study||||||
2667914|NCT01510756|Primary|Overall Response Rate|Determination of absolute lymphocyte count (ALC), lymphadenopathy, splenomegaly, and/or marrow leukemia as measured by 4-color flow minimal residual disease (MRD) panel after 3 cycles of study treatment. (Decrease in absolute lymphocyte count by 50%, decrease in lymphadenopathy (sum of lymph node product) by 50%, decrease in splenomegaly by 50%, or decrease in leukemia infiltration of the bone marrow by 50%.)|3 months|Zero participants analyzed due to termination of study||||||
2667915|NCT01510717|Primary|Mesopic Contrast Sensitivity With Glare at Day 120-180|Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.|||logMAR||Standard Deviation|Mean
2667916|NCT01510717|Primary|Mesopic Contrast Sensitivity Without Glare at Day 120-180|Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic (dim lighting) conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.|||logMAR||Standard Deviation|Mean
2667917|NCT01510717|Primary|Photopic Contrast Sensitivity With Glare at Day 120-180|Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.|||logMAR||Standard Deviation|Mean
2667918|NCT01510717|Secondary|Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180|"Near Spectacle Independence was rated using SILVER, a new patient reported outcome questionnaire. The participant was asked, How often do you wear eyeglasses or contact lenses for seeing objects up close?"|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in at least 1 eye with data present.|||participants|||Number
2667919|NCT01510717|Secondary|Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180|"Overall Spectacle Independence was rated using SILVER (Spectacle Independence Lens Vision Evaluation and Repurchase), a new patient reported outcome questionnaire. The participant was asked, How often do you wear eyeglasses or contact lenses overall?"|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in at least 1 eye with data present.|||participants|||Number
2667920|NCT01510717|Secondary|Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180|VA was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in the primary eye.|||logMAR|Participants|Standard Error|Mean
2667921|NCT01510717|Secondary|Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180|VA was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in the primary eye.|||logMAR|Participants|Standard Error|Mean
2667922|NCT01510717|Primary|Photopic Contrast Sensitivity Without Glare at Day 120-180|Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.|Day 120-180 from second eye implantation|The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.|||logMAR||Standard Deviation|Mean
2667923|NCT01510717|Primary|Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180|Cumulative and persistent adverse events were collected. This outcome measure was prespecified for the multifocal IOL.|Day 0 first operative eye visit, up to Day 120-180 from second eye implantation|This analysis population includes all participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye).|||adverse events|Participants||Number
2667955|NCT01510145|Secondary|Percentage of Subjects Who Reach Target IOP (≤18 mmHg)|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Week 12|This anaylysis population includes all subjects who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit.|||percentage of patients|||Number
2667924|NCT01510717|Primary|Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180|Visual acuity (VA) was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 53 centimeters (cm) on the nearpoint rod. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.|Day 120-180 from second eye implantation|This analysis population includes all participants with successful IOL implantation in the primary eye.|||logMAR|Participants|Standard Error|Mean
2667925|NCT01510704|Primary|Post-operative Nausea or Vomiting||24 hours|ITT|||participants|||Number
2667926|NCT01510652|Secondary|Implant Duration|This measure reports the length (in time) of the implantation procedure. The measurement start at skin incision and stop at skin suture (so called skin-to-skin time) The total implant procedure duration time will be compared between the control and the treatment group.|Total duration of the implant procedure reported at the end of the procedure|The number of participants analyzed is the number of patients with implant data duration time available.|||min||Standard Deviation|Mean
2667927|NCT01510652|Secondary|Percentage of Cardiac Resynchronization Therapy Responders|Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV)|Baseline and 6 months|The number of participants analyzed is the number of patients with echo data received for both baseline and 6 months follow up visits (and so comparable)|||% of patients that are CRT responders|||Number
2667928|NCT01510652|Primary|Lead Performance|"Percentage of patients with freedom from event (intra- and post-operative). Intra-operative events were defined as: need to use more than 1 left ventricular lead, need to change lead implant position, use of any device to actively fixate the lead, unsuccessful implant, due to phrenic nerve stimulation, high pacing threshold or lead instability.~Post-operative events were defined as any left ventricular lead related serious adverse device effect and CRT switched off."|6 months||||% of patients with freedom from event|||Number
2667929|NCT01510457|Primary|Pain Visual Analogue Scale|Pain Visual Analogue Scale from 0-100 (0= no pain, and 100= most pain).|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.||||units on a 100mm pain scale||Standard Deviation|Mean
2667930|NCT01510457|Primary|Center for Epidemiological Studies Depression Scale CESD-10 (CES-D 10)|The CES-D 10 is a 10-item questionnaire that has been validated for the assessment of depressive symptomatology. The Depression Scale is a scale with a sum score from 0 - 30, where 0 = no Depression and 30 = the most Depression.|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.||||units on the depression scale||Standard Deviation|Mean
2667931|NCT01510457|Primary|Pain Disability Index (PDI)|The PDI is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.||||units on a disability scale||Standard Deviation|Mean
2667932|NCT01510457|Primary|Pain Anxiety Symptoms Scale (PASS)|Anxiety scores were collected at least two data points. The Pain Anxiety Symptoms Scale (PASS) is a scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.||||units on an anxiety scale||Standard Deviation|Mean
2667933|NCT01510457|Primary|PamSys Actigraph Data|We used a body worn sensor (PAMSys™, Biosensics, LLC, MA)(25-27) embedded in a comfortable t-shirt at the sternal level. Participants wore the PAMSys after the visit for 48 hours. The device provides values related to subjects spontaneous physical activity including percentage of time standing and walking. These variables provide different indexes of participants' level of activity and activity organization, and were reported by subjects with KOA pain as relevant.|48 hours after visit 3||||percentage of activity (over 48 hours)||Standard Error|Mean
2667934|NCT01510457|Secondary|Daily Diary Entries With Pain, Fatigue and Functioning Scores Three Times a Day|Averages of daily diary outcomes were taken over the first and last week of the trial (week 1 and week 11) to compare pre and post treatment. diary was filled out 3 times a day and asked subjects to rate pain at rest, pain when walking, and fatigue on a scale 0-10 (0=none, and 10=the worst)|electronic diary entries with pain, fatigue and functioning scores were completed three times a day during week 1 and week 11||||units on a 0-10 NRS scale||Standard Deviation|Mean
2667935|NCT01510457|Primary|McGill Pain Questionnaire - Short Form|The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are added together to compute a total score. The scale ranges from 0-45 (0=no pain, 45=the most pain).|Collected at 2 visits over 11 weeks: Visit 1 and Visit 3.||||units on a pain scale||Standard Deviation|Mean
2667936|NCT01510379|Secondary|Quantify the Amounts of Phenergan Used Between the Two Groups.||one week||||mg||Standard Deviation|Mean
2667937|NCT01510379|Primary|Comparison of Postoperative Nausea and Vomiting Scores Between Groups Treated With a ReletexTM Device and Those Without the Device.|Post-operative Nausea and Vomiting (PONV) Likert scale, 0-10 (0=no PONV, 10=worst PONV).|24 hours||||units on a scale||Standard Deviation|Mean
2667938|NCT01510327|Secondary|Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>30 days-1 year|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668033|NCT01509677|Secondary|CD68+ Cell Count in Biopsied Material (Bronchial Epithelium):Poisson Regression Model|"CD68+ Cell Count in biopsied material (Bronchial Epithelium):poisson regression model. Clarification: Measure type Number refers to Treatment Risk"|16 weeks|The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See 11.4.7 in CSR|||CD68+ Cell Count|||Number
2667939|NCT01510327|Secondary|Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|>24 hours-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2667940|NCT01510327|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2667941|NCT01510327|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2667942|NCT01510327|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2667943|NCT01510327|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase (CK) MB or troponin >normal; if no new Q-waves total CK levels >3× normal (peri-percutaneous coronary intervention [PCI]) or >2× normal (spontaneous) with elevated CK-MB or troponin >3× normal (peri-PCI) or >2× normal (spontaneous) plus at least one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5× normal|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2667944|NCT01510327|Secondary|All Death|Number of participants no longer alive|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants who died|||Number
2667945|NCT01510327|Secondary|Total Blood Clearance - Everolimus (CL)|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent.|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; CL could be inaccurately determined for a subset of samples; determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine CL value.|||L/h||Standard Deviation|Mean
2667946|NCT01510327|Secondary|Terminal Phase Half-life (t1/2) Everolimus|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent.|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; half-life could be inaccurately determined for a subset of samples; determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine half-life.|||Hours||Standard Deviation|Mean
2667947|NCT01510327|Secondary|Time of Occurrence of Maximum Everolimus Concentration (Tmax)|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|Analysis groups reported here had 3 or more subjects.|||hours||Standard Deviation|Mean
2667948|NCT01510327|Secondary|Area Under the Concentration Versus Time Curve (AUC 0-infinity) Everolimus|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point), 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after implantation of the last study stent.|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|Analysis groups have ≥3 subjects. Everolimus concentrations declined rapidly in all subjects; AUC0-∞ could be inaccurately determined for a subset of samples. AUC0-∞ determined by extrapolation of terminal phase. Concentrations not above detection limit in the terminal phase for enough time points for most subjects to accurately determine AUC0-∞.|||ng*hr/mL||Standard Deviation|Mean
2667949|NCT01510327|Secondary|Area Under the Concentration Versus Time Curve (AUC 0-24), Everolimus|Venous blood draw up to 24 hours prior to implantation of the first study stent (predose time point) and at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours after completion of implantation of the last study stent|Predose <24 hours; post dose at 30 minutes, 1, 2, 4, 6, 12, 24, 48, and 72 hours|The analysis groups reported here had 3 or more subjects.|||ng*hr/mL||Standard Deviation|Mean
2668034|NCT01509677|Secondary|CD8+ Cell Count in Biopsied Material (Bronchial Epithelium): Poisson Regression Model|"CD8+ Cell Count in biopsied material (Bronchial Epithelium): poisson regression model. Clarification: Measure Type Number refers to Treatment risk"|16 weeks|The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See 11.4.7 in CSR|||CD8+ Cell Count|||Number
2667956|NCT01510145|Primary|Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Baseline, Week 12|This analysis population includes all patients who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit.|||mmHg||Standard Deviation|Mean
2667957|NCT01510028|Secondary|Concentration of SHP611 in Cerebrospinal Fluid|Concentration of SHP611 in CSF was determined using validated enzyme-linked immunosorbent assay (ELISA) method.|Baseline, 4, 8, 12, 16, 20, 24, 28, 32, 36, and 40 weeks|PK set consisted of participants who received at least 1 dose of investigational product and had at least 1 measurable serum concentration or 1 measurable CSF concentration of SHP611.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2667958|NCT01510028|Secondary|Volume of Distribution (Vz/F) After Intrathecal Administration of SHP611|Volume of distribution was associated with the terminal slope following extravascular administration of SHP611 divided by the fraction of dose absorbed.|Baseline: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48 hours postdose; Week 38: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48 hours postdose|PK set consisted of participants who received at least 1 dose of investigational product and had at least 1 measurable serum concentration or 1 measurable CSF concentration of SHP611.|||Liter (L)||Standard Deviation|Mean
2667959|NCT01510028|Secondary|Total Body Clearance (CL/F) After Intrathecal Administration of SHP611|CL/F was defined as the total body clearance of the drug for extravascular administration divided by the fraction of dose absorbed.|Baseline: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48 hours postdose; Week 38: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48 hours postdose|PK set consisted of participants who received at least 1 dose of investigational product and had at least 1 measurable serum concentration or 1 measurable CSF concentration of SHP611.|||Liter per hour (L/h)||Standard Deviation|Mean
2667960|NCT01510028|Secondary|Terminal Elimination Half Life (t1/2) of SHP611|The t1/2 is the time in hours required for the concentration of the drug to reach half of its original value.|Baseline: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48 hours postdose; Week 38: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48 hours postdose|PK set consisted of participants who received at least 1 dose of investigational product and had at least 1 measurable serum concentration or 1 measurable CSF concentration of SHP611.|||Hour (h)||Standard Deviation|Mean
2667961|NCT01510028|Secondary|First Order Rate Constant (Lambda z) Associated With the Terminal (Log-linear) Portion of the Curve for SHP611|Lambda z is first order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.|Baseline: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48 hours postdose; Week 38: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48 hours postdose|PK set consisted of participants who received at least 1 dose of investigational product and had at least 1 measurable serum concentration or 1 measurable CSF concentration of SHP611.|||Per hour (/h)||Standard Deviation|Mean
2667962|NCT01510028|Secondary|Area Under the Concentration-Time Curve From Time Zero to 24 Hours (AUC0-24) of SHP611|Area under the concentration-time curve over the interval from 0 to 24 hours after dosing of SHP611.|Baseline: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48 hours postdose; Week 38: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48 hours postdose|PK set consisted of participants who received at least 1 dose of investigational product and had at least 1 measurable serum concentration or 1 measurable CSF concentration of SHP611.|||hour * nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
2667963|NCT01510028|Secondary|Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of SHP611|AUC0-last is the area under the concentration-time curve from the time of dosing to the last measurable concentration of SHP611.|Baseline: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48 hours postdose; Week 38: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48 hours postdose|PK set consisted of participants who received at least 1 dose of investigational product and had at least 1 measurable serum concentration or 1 measurable CSF concentration of SHP611.|||hour * nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
2667964|NCT01510028|Secondary|Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of SHP611|The AUC0-inf is the area under the concentration-time curve from time zero to infinity of SHP611.|Baseline: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48 hours postdose; Week 38: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48 hours postdose|PK set consisted of participants who received at least 1 dose of investigational product and had at least 1 measurable serum concentration or 1 measurable CSF concentration of SHP611.|||Hour * nanogram/milliliter (h*ng/mL)||Standard Deviation|Mean
2667965|NCT01510028|Secondary|Time to Reach Maximum Observed Drug Concentration (Tmax) of SHP611 in Plasma|Tmax is the time to reach maximum observed drug concentration of SHP611 during a dosing interval.|Baseline: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48 hours postdose; Week 38: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48 hours postdose|PK set consisted of participants who received at least 1 dose of investigational product and had at least 1 measurable serum concentration or 1 measurable CSF concentration of SHP611.|||Hour (h)||Standard Deviation|Mean
2667966|NCT01510028|Secondary|Maximum Observed Serum Concentration (Cmax) of SHP611|Cmax is the maximum observed serum concentration of SHP611.|Baseline: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48 hours postdose; Week 38: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48 hours postdose|Pharmacokinetic (PK) set consisted of participants who received at least 1 dose of investigational product and had at least 1 measurable serum concentration or 1 measurable CSF concentration of SHP611.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2667967|NCT01510028|Secondary|Change From Baseline in Domain-specific Caregiver Observed Metachromatic Leukodystrophy (MLD) Functioning and Outcomes Reporting Tool (COMFORT) Scores at Week 40|COMFORT questionnaire was used to assess health status and the impact of disease on the ability of participants with MLD to carry out activities of daily life. The questionnaire was organized by 8 domains (ie, personal care; positioning, transfer, or mobility; eating; pain and discomfort during the day; sleep; emotions; communication; and play and leisure activities). The COMFORT scores range from 0 to 100, with higher scores indicating a decline in the functioning.|Baseline, Week 40|Safety set consisted of participants who received at least 1 dose of investigational product or underwent device implant surgery. Participants from SHP611 10 mg and SHP611 30 mg were excluded from the analysis. Since, analysis was planned for participants received SHP611 100 mg with different manufacturing processes (Process A and B).|||Score on a scale||Standard Deviation|Mean
2667968|NCT01510028|Secondary|Change From Baseline in Adaptive Behavior Composite Standard Score as Measured by Vineland Adaptive Behavior Scales, Second Edition (VABS-II) at Week 40|The VABS-II test measures adaptive behaviors, including the ability to cope with environmental changes, to learn new everyday skills, and to demonstrate independence. This test measures the following 4 key domains: communication, daily living skills, socialization, motor skills, and the adaptive behavior composite (ABC) (a composite of the other 4 domain). Items in each domain are rated as either 0 (does not), 1(sometimes) or 2(independently) performs a given behavior or skill. The 4 domain standard scores range from 20-160 and higher scores indicate a higher level of functioning. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160) and higher scores indicate a higher level of functioning. A positive change value indicates improvement in adaptive functioning.|Baseline, Week 40|Safety set consisted of participants who received at least 1 dose of investigational product or underwent device implant surgery. Participants from SHP611 10 mg and SHP611 30 mg were excluded from the analysis. Since, analysis was planned for participants received SHP611 100 mg with different manufacturing processes (Process A and B).|||Score on a scale||Standard Deviation|Mean
2667969|NCT01510028|Secondary|Number of Participants With Change in Nerve Conduction as Measured by Electroneurography (ENG) Assessments by Categorized Distal Latency at Week 40|Evaluation of peripheral nerve function by ENG studies was performed to measure nerve conduction velocity (NCV), amplitude (AMP),distal latency (DL), and F-wave latency. Categorized amplitude values were assessed. Data was presented only for number of participants who reported change in distal latency > 0. Here MMW refers to median motor wrist, APB for abductor pollicis brevis, MSW for median sensory wrist, DDL for digit distal latency, PMA for peroneal motor ankle, EDB for extensor digitorum brevis, SSB-point DL for sural sensory B-point distal latency, TMA for tibial motor ankle, abductor hallucis for AH distal latency and, UMW for ulnar motor wrist.|Baseline, Week 40|Safety set consisted of participants who received at least 1 dose of investigational product or underwent device implant surgery.|||Participants|||Count of Participants
2667970|NCT01510028|Secondary|Number of Participants With Change in Nerve Conduction as Measured by Electroneurography (ENG) Assessments by Categorized Nerve Conduction Velocity at Week 40|Evaluation of peripheral nerve function by ENG studies was performed to measure nerve conduction velocity (NCV), amplitude (AMP),distal latency (DL), and F-wave latency. Categorized nerve conduction velocity values were assessed. Data was presented only for number of participants who reported change in nerve conduction velocity > 0. Here MME refers to median motor elbow, WCV for wrist conduction velocity, PMA for peroneal motor ankle, FHCV to fibular head conduction velocity, TMA for tibial motor ankle, KCV for knee conduction velocity and UME for ulnar motor elbow,|Baseline, Week 40|Safety set consisted of participants who received at least 1 dose of investigational product or underwent device implant surgery.|||Participants|||Count of Participants
2667971|NCT01510028|Secondary|Number of Participants With Change in Nerve Conduction as Measured by Electroneurography (ENG) Assessments by Categorized Amplitude Values at Week 40|Evaluation of peripheral nerve function by ENG studies was performed to measure nerve conduction velocity (NCV), amplitude (AMP),distal latency (DL), and F-wave latency. Categorized amplitude values were assessed. Data was presented only for number of participants who reported change in amplitude greater than (>) 0.|Baseline, Week 40|Safety set consisted of participants who received at least 1 dose of investigational product or underwent device implant surgery.|||Participants|||Count of Participants
2667972|NCT01510028|Secondary|Number of Participants With Shift in Functional Endoscopic Evaluation of Swallowing for Aspiration Risk at Week 40|The FEES assessment was performed to evaluate the structure and function of the upper throat during swallowing and for an assessment of aspiration risk. Each participant had this assessment performed at the clinical site using transnasal flexible laryngoscopy. FEES for aspiration risk was assessed. Data was presented only for the shifts observed. Here TL refers to thin liquids, THL refers to thickened liquids, PT refers to puree texture, WCC refers to with cough and clearance and WCNC refers to with cough and no clearance.|Week 40|Safety set consisted of participants who received at least 1 dose of investigational product or underwent device implant surgery.|||Participants|||Count of Participants
2667973|NCT01510028|Secondary|Number of Participants With Shift in Functional Endoscopic Evaluation of Swallowing for Dose Residue Clear After Subsequent Swallowing at Week 40|The FEES assessment was performed to evaluate the structure and function of the upper throat during swallowing and for an assessment of aspiration risk. Each participant had this assessment performed at the clinical site using transnasal flexible laryngoscopy. FEES for dose residue clear after subsequent swallowing was assessed. Data was presented only for the shifts observed. Here TL refers to thin liquids, THL refers to thickened liquids, PT refers to puree texture.|Week 40|Safety set consisted of participants who received at least 1 dose of investigational product or underwent device implant surgery.|||Participants|||Count of Participants
2667974|NCT01510028|Secondary|Number of Participants With Shift in Functional Endoscopic Evaluation of Swallowing for Feeding Assessment (Aspiration Through Vocal Cords) at Week 40|The FEES assessment was performed to evaluate the structure and function of the upper throat during swallowing and for an assessment of aspiration risk. Each participant had this assessment performed at the clinical site using transnasal flexible laryngoscopy. Feeding assessment for aspiration through vocal cords were assessed. Data was presented only for the shifts observed. Here TL refers to thin liquids, THL refers to thickened liquids, PT refers to puree texture, WCC refers to with cough and clearance and WCNC refers to with cough and no clearance.|Week 40|Safety set consisted of participants who received at least 1 dose of investigational product or underwent device implant surgery.|||Participants|||Count of Participants
2667975|NCT01510028|Secondary|Number of Participants With Shift in Functional Endoscopic Evaluation of Swallowing for Feeding Assessment (Laryngeal Penetration) at Week 40|The FEES assessment was performed to evaluate the structure and function of the upper throat during swallowing and for an assessment of aspiration risk. Each participant had this assessment performed at the clinical site using transnasal flexible laryngoscopy. Feeding assessment for laryngeal penetration was assessed. Data was presented only for the shifts observed. Here TL refers to thin liquids, THL refers to thickened liquids, PT refers to puree texture, WCC refers to with cough and clearance and WCNC refers to with cough and no clearance.|Week 40|Safety set consisted of participants who received at least 1 dose of investigational product or underwent device implant surgery.|||Participants|||Count of Participants
2667976|NCT01510028|Secondary|Number of Participants With Shift in Functional Endoscopic Evaluation of Swallowing (FEES) for Texture Utilized at Week 40|The FEES assessment was performed to evaluate the structure and function of the upper throat during swallowing and for an assessment of aspiration risk. Each participant had this assessment performed at the clinical site using transnasal flexible laryngoscopy. FEES for texture utilized was evaluated. Data was presented only for the shifts observed.|Week 40|Safety set consisted of participants who received at least 1 dose of investigational product or underwent device implant surgery.|||Participants|||Count of Participants
2667977|NCT01510028|Secondary|Change From Baseline in Motor Function Using Gross Motor Function Measure 88 (GMFM-88) Total Score at Week 40|The GMFM-88 was used to measure motor function. The GMFM-88 item scores were used to calculate domain-specific percent score for each of the 5 GMFM-88 dimensions (lying and rolling; sitting; crawling and kneeling; standing; walking, running, and jumping), and a total GMFM-88 (percent) score was calculated based on each dimension score. Each of the 88 items was rated on a 4-point scale: 0=does not initiate; 1=initiates; 2=partially completes; and 3=completes. The GMFM-88 total scores ranged from 0% (no mobility) to a score of 100%, that is (i.e,) the score that can be obtained by an average 5-year-old or older child with normal motor abilities.|Baseline, Week 40|Safety set consisted of participants who received at least 1 dose of investigational product or underwent device implant surgery.|||Score on a Scale||Standard Error|Least Squares Mean
2667978|NCT01510028|Primary|Number of Participants With Positive Anti-SHP611 Antibodies in Cerebrospinal Fluid (CSF) and or Serum|Number of participants with positive anti-SHP611 antibody results in serum and in CSF were reported. A participant was considered positive if they had at least 1 positive result during the study.|Baseline up to Week 40|Safety set consisted of participants who received at least 1 dose of investigational product or underwent device implant surgery.|||Participants|||Count of Participants
2667979|NCT01510028|Primary|Number of Participants With Cerebrospinal Fluid (CSF) Chemistry Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs)|CSF chemistry assessments (including cell counts, glucose and protein) was measured. CSF chemistry abnormalities were recorded and reported as TEAE. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as all AEs that occurred at or after the first dose of the investigational product or device implant surgery (whichever occurred earlier) and through the last follow-up date.|From start of study treatment up to Week 40|Safety set consisted of participants who received at least 1 dose of investigational product or underwent device implant surgery.|||Participants|||Count of Participants
2667980|NCT01510028|Primary|Number of Participants With Clinically Significant Abnormalities in Physical Examination Reported as Treatment Emergent Adverse Events (TEAE)|Complete physical examination included evaluation of the port and catheter track. Height or length and weight were recorded and used to calculate growth. Body weight and height measurements were used to calculate the body mass index (BMI). Head circumference was measured in uniform manner for all participants. Clinical significance was defined as any variation in physical findings that had medical relevance resulting in an alteration in medical care. Clinically significant abnormalities related to physical examination were recorded and reported as TEAE. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as all AEs that occurred at or after the first dose of the investigational product or device implant surgery (whichever occurred earlier) and through the last follow-up date.|From start of study treatment up to Week 40|Safety set consisted of participants who received at least 1 dose of investigational product or underwent device implant surgery.|||Participants|||Count of Participants
2667981|NCT01510028|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs)|12-lead ECG was recorded and measured with the participant in rested supine position for at least 10 minutes. ECG abnormalities were recorded and reported as TEAE. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as all AEs that occurred at or after the first dose of the investigational product or device implant surgery (whichever occurred earlier) and through the last follow-up date.|From start of study treatment up to Week 40|Safety set consisted of participants who received at least 1 dose of investigational product or underwent device implant surgery.|||Participants|||Count of Participants
2667982|NCT01510028|Primary|Number of Participants With Vital Sign Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs)|Vital sign assessments included blood pressure, heart rate, respiratory rate and body temperature. Vital sign abnormalities were recorded and reported as TEAE. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as all AEs that occurred at or after the first dose of the investigational product or device implant surgery (whichever occurred earlier) and through the last follow-up date. Vital sign abnormalities included pyrexia which was considered as TEAE and was reported.|From start of study treatment up to Week 40|Safety set consisted of participants who received at least 1 dose of investigational product or underwent device implant surgery.|||Participants|||Count of Participants
2667983|NCT01510028|Primary|Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs)|Clinical laboratory test included serum chemistry, hematology and urinalysis. Clinical laboratory abnormalities were recorded and reported as TEAE. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as all AEs that occurred at or after the first dose of the investigational product or device implant surgery (whichever occurred earlier) and through the last follow-up date.|From start of study treatment up to Week 40|Safety set consisted of participants who received at least 1 dose of investigational product or underwent device implant surgery.|||Participants|||Count of Participants
2668009|NCT01509807|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time the discharge order is written or Day 30, whichever is sooner|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||mg morphine equivalent||Standard Deviation|Mean
2667984|NCT01510028|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Type and Severity|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were defined as all AEs that occurred at or after the first dose of the investigational product or device implant surgery (whichever occurred earlier) and through the last follow-up date. Drug-related and device-related types of TEAEs were analyzed and reported. The severity of AEs was assessed by the investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 grading scale. Severity of all AEs or SAEs was recorded as grade 1, 2, 3, 4, or 5 corresponding, respectively, to a severity of mild, moderate, severe, life-threatening, or fatal. Here SDI refers to surgical device implantation.|From start of study treatment up to Week 42|Safety set consisted of participants who received at least 1 dose of investigational product or underwent device implant surgery.|||Participants|||Count of Participants
2667985|NCT01509950|Secondary|Level of Patient's Overall Patient Satisfaction to the Type of Closure|Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)|Post-operative week 6|No patients had data available for the analysis.||||||
2667986|NCT01509950|Secondary|Level of Patient's Overall Patient Satisfaction to the Type of Closure|Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)|Post-operative day 3 or 4|Only patients with available data were included in the analysis.|||units on a scale||Inter-Quartile Range|Median
2667987|NCT01509950|Secondary|Level of Patient's Overall Patient Satisfaction to the Type of Closure|Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)|Post-operative day 1|Only patients with available data were included in the analysis.|||units on a scale||Inter-Quartile Range|Median
2667988|NCT01509950|Secondary|Level of Patient's Satisfaction to the Cosmesis of the Wound|Measured on a scale of 0 (very unsatisfied to the cosmesis) to 10 (very satisfied to the cosmesis)|Post-operative week 6|Only patients with available data were included in the analysis.|||units on a scale||Inter-Quartile Range|Median
2667989|NCT01509950|Secondary|Time Needed for the Suture Removal|Measured in seconds|Post-operative day 3 or 4|Only patients with available data were included in the analysis.|||seconds||Inter-Quartile Range|Median
2667990|NCT01509950|Secondary|Time From Skin Incision to the Skin Closure|Measured in minutes|Day of cesarean delivery (up to 8 hours)||||minutes||Inter-Quartile Range|Median
2667991|NCT01509950|Secondary|Level of Patient Satisfaction to the Wound Appearance at 6 Weeks Postpartum|Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)|Post-operative week 6|"There were no patients that had data available for analysis for staples and prolene non-absorbable sutures study arms."||||||
2667992|NCT01509950|Secondary|Level of Patient Satisfaction to the Wound Appearance|Level of patient satisfaction measured on a scale of 1 (very unsatisfied) to 10 (very satisfied)|Post-operative day 3 or 4|Only patients with available data were included in the analysis.|||units on a scale||Inter-Quartile Range|Median
2667993|NCT01509950|Secondary|Count of Participants With Wound Complications|Wound complications include conditions like infection, seroma/hematoma and dehiscence|Post-operative week 6|Only patients with available data were included in the analysis.|||Participants|||Count of Participants
2667994|NCT01509950|Secondary|Level of Pain on a Scale at 6 Weeks Postpartum|Pain level on a scale (Mosby visual analog pain scale) of 1 (no pain) to 10 (worst pain).|Post-operative week 6|Only patients with available data were included in the analysis.|||units on a scale||Inter-Quartile Range|Median
2667995|NCT01509950|Primary|Level of Pain on a Scale During the Post-operative Hospitalization Period|Pain level on a Mosby visual analog pain scale of 1 (no pain) to 10 (worst pain)|Post-operative day 3 or 4.|Only patients with available data were included in the analysis.|||units on a scale||Inter-Quartile Range|Median
2667996|NCT01509872|Secondary|Change in Pro-Social Behaviors as Measured by the African Youth Psychosocial Assessment Instrument|The African Youth Psychosocial Assessment Instrument is a self-report questionnaire that measures internalizing, externalizing, conduct and pro-social (daily life functioning) skills symptoms. The Congolese Swahili version of the AYPA contained 8 questions about pro-social behavior and assesses the frequency of occurrence of positive behaviors (e.g. sharing with others, listening to others and elders etc.) during the past week (rated from 0 = none of the time to 4 = most of the time). The lowest score obtainable on the measure was 0, while the highest score obtainable was 32. Although no cut-off score was used, the higher the score on the scale, the more pro-social the individual's behavior is.|baseline, 3-week post-intervention, 6-month follow up||||units on a scale||Standard Deviation|Mean
2667997|NCT01509872|Secondary|Change in Externalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument|The African Youth Psychosocial Assessment Instrument is a self-report questionnaire that measures internalizing, externalizing, conduct and pro-social (daily life functioning) skills symptoms. The Congolese Swahili version of the AYPA contained 10 questions about symptoms of conduct disorder and assesses the frequency of occurrence of externalizing symptoms during the past week (rated from 0 = none of the time to 4 = most of the time). The lowest score obtainable on the measure was 0, while the highest score obtainable was 40. Although no cut-off score was used, the higher the score on the scale, the greater the psychosocial adjustment difficulties being reported.|baseline, 3-week post-intervention, 6-month follow up||||units on a scale||Standard Deviation|Mean
2667998|NCT01509872|Secondary|Change in Internalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument|The African Youth Psychosocial Assessment Instrument is a self-report questionnaire that measures internalizing, externalizing, conduct and pro-social (daily life functioning) skills symptoms. The Congolese Swahili version of the AYPA contained 19 questions on internalizing symptoms and assesses the frequency of occurrence of internalizing symptoms during the past week (rated from 0 = none of the time to 4 = most of the time). The lowest score obtainable on the measure was 0, while the highest score obtainable was 76. Although no cut-off score was used, the higher the score on the scale, the greater the psychosocial distress being reported.|baseline, 3 week post-intervention and 6 month follow up||||units on a scale||Standard Deviation|Mean
2668010|NCT01509677|Secondary|Wicoxon Signed-rank Test for Change From V2 to V6 in Post-bronchodilator FEV1/FVC|Wilcoxon test is a non-parametric test to evaluate differences among treatments in the variable that is being reported here. The data reported in the outcome measure data table are hodges Lehmann estimate of change from baseline in FEV1/FVC ratio.|Baseline to 16 weeks||||ratio||95% Confidence Interval|Median
2667999|NCT01509872|Primary|Change in Post-traumatic Stress Symptoms as Measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index|The UCLA PTSD Reaction Index is a self-report questionnaire that measures exposure to traumatic events and assesses post-tramatic stress symptoms in school-age children and adolescents. The Congolese Swahili version used in the study had 22 items and assesses the frequency of occurrence of PTSD symptoms during the past week (rated from 0 = none of the time to 4 = most of the time). The scale ranged from 0 (no symptoms) to 88 (highest score possible). Although no cut-off score was used, the higher the score of the scale the higher the number of PTSD symptoms experienced.|baseline, 3 week post-intervention and 6-month follow up||||units on a scale||Standard Deviation|Mean
2668000|NCT01509807|Secondary|Experienced Any Health Problems or Changed in Health Since Hospital Discharge|Yes, if patient experienced any health problems or changes in health since hospital discharge; no, if patient did not experience health problems or changes since hospital discharge; not reported, if applicable.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||participants|||Number
2668001|NCT01509807|Secondary|Contact or Attempt to Contact Surgeon/Doctor to Discuss Recovery After Surgery|Yes, if patient contacted or attempted to contact surgeon/doctor to discuss recovery after surgery; no, if patient did not contact or attempt contact; not reported if applicable.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||participants|||Number
2668002|NCT01509807|Secondary|Make Unplanned VIsit(s) With Any Healthcare Providers|Yes, if patient made an unplanned visit with a healthcare provider; no, if patient did not make an unplanned visit with a healthcare provider; not reported, if applicable|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||participants|||Number
2668003|NCT01509807|Secondary|Readmission to Hospital Since Discharge|Yes, if patient was readmitted to hospital since discharge; no, if patient was not readmitted to hospital since discharge; not reported, if appropriate.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||participants|||Number
2668004|NCT01509807|Secondary|Patient Discharged From the Hospital for at Least 3 Days|Yes, if patient was discharged from the hospital for at least 3 days; no, if patient was not discharged for at least 3 day; not reported if appropriate|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||participants|||Number
2668005|NCT01509807|Secondary|Patient Satisfaction With Postsurgical Analgesia|Responses to question pertaining to patient satisfaction with postsurgical analgesia described by total percentage indicating satisfied or extremely satisfied.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||percentage of patients|||Number
2668006|NCT01509807|Primary|Health Economic Benefit - Length of Stay|Time from completion of wound closure until hospital discharge written or through Day 30, whichever was sooner|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||days||Full Range|Median
2668007|NCT01509807|Secondary|Incidence of Opioid-related Adverse Events|Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||events|||Number
2668008|NCT01509807|Primary|Health Economic Benefits - Total Cost of Hospitalization|1) Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|The Efficacy Analysis Set had 11 participants in Group 1 and 16 participants in Group 2. The Efficacy Analysis Set was defined as those patients who underwent the planned surgery, did not meet any of the intraoperative exclusion criteria, and had provided informed consent. In addition, the Group 2 patients must have received study drug (EXPAREL).|||dollars||Standard Deviation|Mean
2668011|NCT01509677|Secondary|Change From Baseline in Lung Function Variables: Between-Treatment Differences (FAS) (FVC (L))||Baseline to 16 weeks||||L||Standard Error|Least Squares Mean
2668012|NCT01509677|Secondary|Change From Baseline in Lung Function Variables: Between-Treatment Differences (FAS) (FEV1 (L))||Baseline to 16 weeks||||L||Standard Error|Least Squares Mean
2668035|NCT01509677|Secondary|Neutrophils Cell Counts in Biopsied Material (Submucosa):Poisson Regression Model|"Neutrophils Cell Counts in biopsied Material (submucosa):poisson regression model. Clarification: Measure type Number refers to Treatment risk"|Baseline to 14 weeks|The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See 11.4.7 in CSR|||Neutrophils Cell Counts|||Number
2668036|NCT01509677|Secondary|CD45+ Cell Counts in Biopsied Material (Submucosa):Poisson Regression Model|"CD45+ Cell Counts in biopsied Material (submucosa):poisson regression model. Clarification: Measure type Number refers to treatment risk"|16 weeks|The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See 11.4.7 in CSR|||CD45+ Cell Counts|||Number
2668037|NCT01509677|Secondary|CD4+ Cell Counts in Biopsied Material (Submucosa):Poisson Regression Model|"CD4+ Cell Counts in biopsied Material (submucosa):poisson regression model. Clarification: Measure type Number refers to Risk of each treatment group."|16 weeks|The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See 11.4.7 in CSR|||CD4+ Cell Counts|||Number
2668038|NCT01509677|Secondary|Change From V2 to V6 in CD68+ Cell Count (Cells/mm^2) in Biopsied Material (Submucosa) (ITT)||Baseline and 16 weeks|The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See 11.4.7 in CSR|||CD68+ Cell Count (cells/mm^2)||Standard Error|Least Squares Mean
2668039|NCT01509677|Secondary|CD68+ Cell Count in Biopsied Material (Submucosa): Poisson Regression (Ratio)|"CD68+ Cell Count in Biopsied Material (submucosa): Poisson regression (ratio). Clarification: Measure type described as Number refers to Risk of each treatment group. It is not possible to select risk from this template so number was selected instead. This issue applies to similar variables reporting poisson regression."|16 weeks|The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See 11.4.7 in CSR|||CD68+ Cell Count|||Number
2668040|NCT01509677|Secondary|CD68+ Count in Biopsied Material (Submucosa)||16 weeks|The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See 11.4.7 in CSR|||CD68+ Count||Standard Deviation|Mean
2668041|NCT01509677|Primary|Change in Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue||Baseline to 16 weeks|The CD8+ cells count results in submucosa for the primary outcome were available for 117 patients at V2 (41 missing) and 114 patients at V6 (44 missing). The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See section 11.4.1 in CSR|||cells/mm^2||Standard Deviation|Mean
2668042|NCT01509677|Primary|Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue.||16 weeks|The CD8+ cells count results in submucosa for the primary outcome were available for 117 patients at V2 (41 missing) and 114 patients at V6 (44 missing). The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See section 11.4.1 in CSR|||CD8+ cells count||Standard Deviation|Mean
2668043|NCT01509664|Primary|Gross Weekly Purchasing of Fruits and Vegetables|Gross weekly purchasing of fruits and vegetables from the discounted items list in $|week||||$||Standard Error|Mean
2668044|NCT01509638|Secondary|Time to First Opioid Administration|Time in hours to first opioid administration|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||hours||Full Range|Median
2668045|NCT01509638|Secondary|Experienced Health Problems or Changes in Health Since Hospital Discharge|Yes, if experienced health problems or changes in health; No, if did not experience health problems or changes in health; not reported, if applicable|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||participants who answered yes|||Number
2668046|NCT01509638|Secondary|Contact or Attempted to Contact Surgeon/Doctor to Discuss Recovery After Surgery|Yes, if contacted or attempted to contact; No, if did not contact and did not attempt to contact; not reported, if applicable.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||participants who answered yes|||Number
2668047|NCT01509638|Secondary|Patient Made Unplanned Visit(s) With Any Healthcare Providers|Yes, if patient made unplanned visit(s); No, if patient did not make unplanned visits; not reported, if applicable|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||participants who answered yes|||Number
2668048|NCT01509638|Secondary|Patient Discharged From Hospital for at Least 3 Days|Yes, if patient discharged from hospital for at least 3 days; no, if patient not discharged from hospital for at least 3 day; not reported, if applicable.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||participants|||Number
2668049|NCT01509638|Secondary|Patient Satisfaction With Postsurgical Analgesia|Responses to one question pertaining to patient satisfaction with postsurgical analgesia|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||participants|||Number
2668050|NCT01509638|Secondary|Incidence of Opioid-related Adverse Events|Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||number of events||Standard Deviation|Mean
2668968|NCT01499810|Secondary|Change in Mean 24-h Diastolic BP||from baseline to 12 months|Number of participants assessed at 12 months minus 1 participant with unsatisfactory ABPM record|||mmHg||Standard Deviation|Mean
2668051|NCT01509638|Primary|Health Economic Benefit|Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||days||Full Range|Median
2668052|NCT01509638|Primary|Health Economic Benefits|Total cost of hospitalization until the time the discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.|22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||dollars||Standard Deviation|Mean
2668053|NCT01509638|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order is written or Day 30, whichever is sooner|22 patients from Group 1 and 25 patients from Group 2 were in the Safety Analysis Set (patients who underwent planned surgery). Efficacy Analysis Set was 20 patients from Group 1 and 23 from Group 2 (planned surgery, no exclusion criteria, informed consent, Group 2 received EXPAREL)|||mg morphine equivalent||Standard Deviation|Mean
2668054|NCT01509625|Secondary|Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Elevated Ki-67 and With Low Ki-67|To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose in terms of PFS in a subgroup of patients with elevated ki-67 (greater than or equal to 20%) and with low ki-67 and to compare both groups|22 months|We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were no information regarding tumor ki67 expresion in 121 patients.|||month||95% Confidence Interval|Median
2668055|NCT01509625|Secondary|Response to Treatment With Fulvestrant in Terms of PFS in Subgroups of Patients With Her-2 Overexpression and Those Who do Not Over-express Her-2|"To assess the response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS in subgroups of patients with her-2 overexpression (+++ by immunohistochemistry or FISH positive) and those who do not over-express her-2 and to compare both groups.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks)."|22 months|We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were no information regarding HER2 status in 31 patients.|||month||95% Confidence Interval|Median
2668056|NCT01509625|Secondary|Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients After a First-line Hormonal Therapy Prior and in Subgroup of Patients After Two or More Prior Lines of Hormonal Therapy|To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose in terms of PFS in a subgroup of patients after a first-line hormonal therapy prior and in subgroup of patients after two or more prior lines of hormonal therapy|22 months|We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were 5 patients that have not received previous tamoxifen or an aromatases inhibitor, so they are not included in one of these two groups.|||month||95% Confidence Interval|Median
2668057|NCT01509625|Secondary|Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Visceral Metastases and Without Visceral Metastases|"Response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS in a subgroup of patients with visceral metastases and without visceral metastases.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks)."|22 months|We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients.|||month||95% Confidence Interval|Median
2668058|NCT01509625|Secondary|Number of Participants With Adverse Events||22 months||||percentage of patients||95% Confidence Interval|Number
2668059|NCT01509625|Secondary|Duration of Clinical Benefit|"Response to treatment with fulvestrant in terms of Duration of the Clinical Benefit.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks)."|22 months|For the study of the duration of the clinical benefit, only the patients that get a clinical benefit could be analyzed (this is the reason becasuse the number of participants analyzed was 140)|||month||95% Confidence Interval|Median
2668060|NCT01509625|Secondary|Overall Survival|Response to treatment with fulvestrant in terms of Overall Survival|22 months||||month||95% Confidence Interval|Median
2668061|NCT01509625|Secondary|Clinical Benefit Rate|Response to treatment with fulvestrant in terms of Clinical Benefit Rate. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks).|22 months||||percentage of patients|||Number
2668062|NCT01509625|Primary|Progression Free Survival|"Response to treatment with fulvestrant (Faslodex®) in terms of Progression Free Survival.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% or more increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|22 months||||month||95% Confidence Interval|Median
2668063|NCT01509586|Primary|Quit Attempts and Abstinence|"% of study participants making a quit attempt or staying abstinent from smoking during the study~Notes:~Floating abstinence: Any 7-day period of non-smoking, ever within study. PPA: point-prevalence abstinence"|From study enrollment through end of one-year follow up||||percentage of participants|||Number
2668064|NCT01509547|Secondary|Number of Participants Achieving 7+ Days Abstinence at Any Point During Treatment|Number of participants achieving 7+ days of self-reported abstinence at any point during active treatment|12 weeks of active treatment||||Participants|||Count of Participants
2668065|NCT01509547|Secondary|Percentage of Post-treatment Visits With Abstinence|Self-reported abstinence at post-treatment follow-up visits (reported as percentage of total possible post-treatment follow-up visits at which abstinence in the prior week was self-reported). Missing data were imputed to non-abstinence.|One week abstinence at the Week 16 and Week 26 post-treatment follow-up visits||||percentage of visits with abstinence||95% Confidence Interval|Number
2668066|NCT01509547|Secondary|Percentage of Visits With Abstinence During Treatment|Self-reported between-visit abstinence at weekly visits during treatment (reported as percentage of total possible visits across all participants at which participants self-reported abstinence). Missing data were imputed to non-abstinence.|12 weeks (all of active treatment)||||percentage of visits with abstinence||95% Confidence Interval|Number
2668067|NCT01509547|Primary|Number of Participants Experiencing Treatment-emergent Adverse Events|Clinician-collected adverse events (regardless of relatedness to medication) occurring at any point after randomization and initiation of treatment.|26 weeks (12 weeks of treatment plus full post-treatment follow-up)||||Participants|||Count of Participants
2668068|NCT01509547|Primary|Number of Participants With Cotinine-confirmed 7-day Point Prevalence Abstinence at the End of Treatment|Self-reported 7-day cigarette abstinence, confirmed by urine corinne ≤50 ng/mL at the end-of-treatment (week 12) visit|7 days at end of treatment|Intent-to-treat population|||Participants|||Count of Participants
2668069|NCT01509404|Secondary|Number of Participants With CMV Seroconversions||2 years||||Participants|||Count of Participants
2668070|NCT01509404|Secondary|Number of Participants With Asymptomatic CMV Viremia||2 years||||Participants|||Count of Participants
2668071|NCT01509404|Secondary|Number of Participants With Opportunistic Infections||2 years||||Participants|||Count of Participants
2668072|NCT01509404|Secondary|Number of Participants With Acute Cellular and/or Antibody Mediated Rejection||2 years||||Participants|||Count of Participants
2668073|NCT01509404|Secondary|Renal Function|Renal function will be assessed by an estimated creatinine clearance utilizing the abbreviated Modification of Diet in Renal Disease (MDRD) equation at 6, 12, and 24 months after transplant|6, 12, and 24 months after transplant||||mL/min/1.73m^2||Full Range|Mean
2668074|NCT01509404|Secondary|Number of Patients With Cell Mediated Immunity|Positive CMV quantiferon at last follow-up|2 years||||Participants|||Count of Participants
2668075|NCT01509404|Secondary|Number of Patients With Early CMV Infection||100 days||||Participants|||Count of Participants
2668076|NCT01509404|Primary|Number of Patients With Late CMV Disease|Number of any clinically significant late CMV disease, defined as CMV syndrome or tissue-invasive disease occurring after the first 200 days post transplant|after 200 days post-transplant until 2 years post-transplant||||Participants|||Count of Participants
2668077|NCT01509183|Secondary|Change in the Proportion of SABA-free Days From Baseline to 12 Months|Evaluate the change in the proportion of SABA-free days from baseline to 12 months|Baseline to 12 months||||% Change in proportion of SABA-free days|||Number
2668078|NCT01509183|Primary|Change in Mean SABA Use|Mean SABA use as measured by the Propeller Health sensor during the period of intervention (12 months).|Change in mean SABA use over the course of 12 months||||mean puffs per day||Standard Deviation|Mean
2668079|NCT01509105|Secondary|Number of Participants Discontinued Due to Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Baseline up to 28 days after last dose of study vaccination (13 Months)|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up.|||participants|||Number
2668080|NCT01509105|Secondary|Number of Participants With Outcome in Response to Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by those participants who had at least 1 AE: 'Is the adverse event still present?' as 'yes', 'unknown' or 'no-resolved'.|Baseline up to 28 days after last dose of study vaccination (13 Months)|"Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, N signifies those participants who had at least 1 adverse event."|||participants|||Number
2668081|NCT01509105|Secondary|Number of Participants With Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).|Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4|"Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, n signifies those participants who were evaluable at specified time points."|||participants|||Number
2668104|NCT01509040|Secondary|Clinical Safety Outcomes; Number of Participants With Clinical Diagnoses|Clinical diagnoses of cerebral bleeding, stroke, bleeding requiring transfusion or surgical intervention, rearrest, pulmonary edema, rib or sternal fractures, internal thoracic or abdominal injuries as noted in the discharge summary|Discharge||||participants|||Number
2668082|NCT01509105|Secondary|Duration of Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time from onset of adverse event till the event is resolved in participants who had at least 1 AE.|Baseline up to 28 days after last dose of study vaccination (13 Months)|"Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, N signifies those participants who had at least 1 adverse event."|||days||Standard Deviation|Mean
2668083|NCT01509105|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Within 28 days after Vaccination 4|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2668084|NCT01509105|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Within 7 days after Vaccination 3|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2668085|NCT01509105|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Within 7 days after Vaccination 2|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2668086|NCT01509105|Primary|Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Within 7 days after Vaccination 1|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2668087|NCT01509105|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Within 28 days after Vaccination 4|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2668088|NCT01509105|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Within 7 days after Vaccination 3|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2668089|NCT01509105|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Within 7 days after Vaccination 2|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “N” signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2668969|NCT01499810|Secondary|Change in Mean 24-h Systolic BP||from baseline to 12 months|Number of participants assessed at 12 months minus 1 participant with unsatisfactory ambulatory blood pressure monitoring (ABPM) record|||mmHg||Standard Deviation|Mean
2668090|NCT01509105|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Within 7 days after Vaccination 1|Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, “number of participants analyzed” (N) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2668091|NCT01509079|Secondary|Vitamin D Binding Protein Genotype||Baseline|Due to funding limitations, this secondary aim was not collected and analyzed in these groups||||||
2668092|NCT01509079|Secondary|Whole Body Bone Mineral Density|GLM Mean and standard deviation of Whole Body Bone Mineral Density (grams/cm2) of Trial Participants by Treatment Arm after controlling for bisphosphonate use|From Baseline and 6 months of D3 supplementation||||gm/cm2||Standard Deviation|Geometric Least Squares Mean
2668093|NCT01509079|Secondary|Change in Steady State Concentrations of Serum Anastrazole and Letrozole|Difference in steady state concentrations in plasma from baseline to 6 months|baseline to 6 months|Only study participants with baseline and 6 month blood samples available were analyzed|||mg/L||Standard Deviation|Mean
2668094|NCT01509079|Secondary|Serum Estradiol Concentrations||baseline and 6 months|only participants whose serum was obtained at both time points are included|||pg/ml||Standard Error|Geometric Mean
2668095|NCT01509079|Secondary|Average Percent Adherence to Vitamin D Interventio|adherence measured with pill counts for the vitamin D at predesignated study timepoints: baseline (after run-in), 3 months and 6 months|average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 months||||% of adherence for each treatment arm|||Number
2668096|NCT01509079|Secondary|Change in PROMIS Physical Functioning Questionnaire|PROMIS measures physical functioning on the short form and higher scores reflect better physical functioning with 10 questions on daily activities of life on a Likert scale ranging from 5 (no problem performing activity) to 1 (cannot do activity). Range on this measure is from 50 (best)-10 (worst).|baseline to 6 months|only data from participants with measures at both time points are included|||units on a scale||Standard Deviation|Mean
2668097|NCT01509079|Primary|Change in Hand Grip Strength||baseline to 6 months|only data from participants that were collected at both time points is included|||pounds||Standard Deviation|Mean
2668098|NCT01509079|Primary|Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale|The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia|baseline to 6 months|Only participants who provided data at both time points are included|||units on a scale||Standard Deviation|Mean
2668099|NCT01509053|Secondary|Clinical Global Impression of Improvement (CGI-I) Score|"The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: Compared to his/her condition at baseline (prior to randomization), how much has the patient changed? using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement."|Baseline, Week 24|Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.||||||
2668100|NCT01509053|Secondary|Clinical Global Impression of Severity (CGI-S) Score|"The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? using an 8-point scale where 0=not assessed to 7=among the most extremely ill patients."|Baseline, Week 24|Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.||||||
2668101|NCT01509053|Secondary|Change From Baseline in PANSS Positive and Negative Subscale Scores|The PANSS Positive Subscale consisted of 7 symptom constructs rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Positive Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. The PANSS Negative Subscale consisted of 7 symptom constructs rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The total score on the Negative Subscale ranged from 7 to 49 with a higher score indicating more severe symptoms. A Negative change from Baseline indicated improvement.|Baseline, Week 24|Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.||||||
2668102|NCT01509053|Secondary|Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS consisted of 3 subscales with a total of 30 symptom constructs each rated on a 7-point scale where 1=absence of symptoms to 7=extremely severe symptoms. The Positive Subscale consisted of 7 positive symptom constructs with a possible subscale score of 7 to 49, the Negative Subscale consisted of 7 negative symptom constructs with a possible subscale score of 7 to 49 and the General Psychopathology Subscale consisted of 16 symptom constructs for a possible subscale score of 16 to 112. The PANSS Total Score ranged from 30 (best) to 210 (worst; indicating more severe symptoms). A Negative change from Baseline indicated improvement.|Baseline, Week 24|Due to the low number of enrolled patients and the sponsor's early termination of the study, this endpoint was not evaluated.||||||
2668103|NCT01509053|Primary|Comparison of Inpatient Psychiatric Hospitalization Rates|The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥1 inpatient psychiatric hospitalizations) between the retrospective period Months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B Months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot.|Retrospective period Months 4-6; Prospective period Months 4-6|Due to the low number of enrolled patient and the sponsor's early termination of the study, the primary efficacy endpoint was not evaluated.||||||
2668970|NCT01499810|Secondary|Change in Office Diastolic BP||from baseline to 12 months||||mmHg||Standard Deviation|Mean
2668105|NCT01509040|Secondary|Unexpected Adverse Device Events (UADE)|These will be defined as any unexpected adverse effect on health or safety or any unexpected life-threatening problem caused by, or associated with, a device, if that effect or problem was not previously identified in nature, severity, or degree of incidence in this investigation plan or application which will be submitted to the Food and Drug Administration (including a supplementary plan or application), or any other unexpected serious problem associated with a device. The death or neurological impairment of an individual patient will not be considered an adverse event in this study.|48 hours||||participants|||Number
2668106|NCT01509040|Secondary|Safety Outcome, Number of Participants With STEMI, Radiographic Pulmonary Edema, or Arrhythmia|"ST-Elevation Myocardial Infarction- ECG criteria and biomarker criteria for acute infarction.~Radiographic Pulmonary Edema- radiographic presence of alveolar or interstitial edema, bilateral pleural effusions, cardiomegaly or venous congestion.~Arrhythmia- other than sinus rhythm observed after randomization. Arrhythmia requiring treatment- rhythm with subsequent use of an antiarrhythmic drug or electrical therapy observed after randomization.~Arrhythmia with cardiovascular instability- any rhythm with cardiovascular instability as determined by the DSMB, observed after randomization."|48 hours||||Participant|||Number
2668107|NCT01509040|Secondary|Expected Adverse Event|"Device-Related Hematoma at insertion site, vessel perforation, wound infection, deep venous thrombosis or pulmonary embolism.~Device Failure Mechanical failure Hypertension- SBP>160 mmHg, or DBP >120 mmHg. Hypotension- SBP<60 mmHg. Hypervolemia- CVP > 12 cm. Hypovolemia- CVP < 2 cm. Hypokalemia- serum potassium concentration < 3.5 mmol/L. Alkalosis- serum bicarbonate > 32 mmol/L. Hyperglycemia- serum glucose > 240 mg/dL. Hypophosphatemia- serum phosphate concentration < 0.8 mmol/L. Hypocalcemia- serum ionized calcium < 2.2 mmol/L. Lactic acidosis- serum lactate > 6 mmol/L."|48 hours||||participants|||Number
2668108|NCT01509040|Secondary|Time Interval From 911 Call to Patient Death|This will be described for all hospitalized patients as a measure of morbidity after resuscitation.|1 year||||Days||Inter-Quartile Range|Mean
2668109|NCT01509040|Secondary|Number of Hospital Days|This will be described for all hospitalized patients as a measure of morbidity after resuscitation.|6 months||||days||Inter-Quartile Range|Mean
2668110|NCT01509040|Secondary|Ejection Fraction|This will be assessed by standard transthoracic echocardiographic methods 48 hours after enrollment in control and intervention patients|48 hours||||percentage||Inter-Quartile Range|Mean
2668111|NCT01509040|Secondary|Shock|This will be defined as systolic blood pressure < 65 at the end of any four hour period during the initial 48 hours of enrollment in control and intervention patients.|48 hours||||participants|||Number
2668112|NCT01509040|Secondary|Use of Pressors and Inotropes|This includes use of dopamine, dobutamine, epinephrine, nesiritide, norepinephrine, or phenylephrine during the first 48 hours from enrollment.|48 hours||||participants|||Number
2668113|NCT01509040|Secondary|Total Volume Intravenous Fluid Infused|This will be defined as the volume of fluid (in mL) infused during the first 48 hours from enrollment.|48 hours||||mL||Inter-Quartile Range|Mean
2668114|NCT01509040|Secondary|Clearance of Inflammatory Mediators|Venous blood samples will be obtained periodically after randomization, processed, stored, then tested for serum cytokine levels.|48 hours|The outcome was not assessed.||||||
2668115|NCT01509040|Secondary|Enrollment|This will be defined as the proportion of eligible patients who are randomized.|12 hours||||participants|||Number
2668116|NCT01509040|Primary|Intervention Compliance|Intervention Compliance will be defined as the proportion of intervention patients who are alive and undergo hemofiltration (HF) for at least 80% of 48 hours from randomization.|48 hours||||participants|||Number
2668117|NCT01508936|Secondary|Participants With a Positive Anti-Reslizumab Antibody Status During Study|"Counts of participants with a positive anti-drug antibody (ADA) response during treatment is offered for the experimental treatment arm. Blood samples were collected for determination of ADAs before study drug infusion at screening, weeks 8 and 16 or early withdrawal. Serum samples from patients who were treated with reslizumab were analyzed for ADA by Teva (Teva Biopharmaceuticals USA, Rockville, MD) using a validated homogeneous solution-based bridging enzyme-linked immunosorbent assay (ELISA).~Endpoint =week 16 or early withdrawal.~Counts represent the total number of participants at each time point with a positive immunogenicity test, and not 'new' participants with a positive test. An overall status of positive includes participants who had a positive ADA at any time point."|Screening (Week -3), Weeks 8 and 16|Safety analysis set; antibody assessments reported for active treatment arm only.|||participants|||Number
2668118|NCT01508936|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Electrocardiogram (ECG) Abnormalities|Counts represent the number of participants with potentially clinically significant ECG abnormalities as assessed by the investigator.|Week 16 or endpoint|Safety analysis set|||participants|||Number
2668119|NCT01508936|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values|"Data represents participants with potentially clinically significant (PCS) vital sign values during any of the treatment period exams.~Significance criteria~Heart rate - high: >100 and increase of >= 30 beats/minute (bpm)~Sitting systolic blood pressure - high: >160 and increase of >=30 mmHg~Sitting systolic blood pressure - low: <90 and decrease of >=30 mmHg~Sitting diastolic blood pressure - high: >100 and increase of >=12 mmHg~Sitting diastolic blood pressure - low: <50 and decrease of >=12 mmHg~Body temperature - high: >100.5° Fahrenheit or 38.1° Celsius and increase of >2°~Body temperature - low: <96.5° Fahrenheit or <35.8° Celsius"|Week 4 to Week 28|Safety analysis set of participants with assessments|||participants|||Number
2668120|NCT01508936|Secondary|Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values|"Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values during any of the lab tests conducted during the treatment period.~Significance criteria:~Blood urea nitrogen: >=10.71 mmol/L~Creatinine: >=177 μmol/L~Uric acid: M>=625, F>=506 μmol/L~Aspartate aminotransferase: >=3*upper limit of normal (ULN). Normal range is 10-43 U/L~Alanine aminotransferase: >=3*ULN. Normal range is 10-40 U/L~GGT = gamma-glutamyl transpeptidase: >= 3*ULN. Normal range is 4-49 U/L.~Total bilirubin: >=34.2 μmol/L~Creatinine phosphokinase: >5*ULN. Normal range is 24-207 U/L.~White blood cells: <=3.0 or >20 10^9/L~Hemoglobin: M<=115, F<=95 g/dL~Hematocrit: M<0.37, F<0.32 L/L~Platelets: <=75 10^9/L~Absolute neutrophil count: <=1.0 10^9/L~Urinalysis: blood, glucose, ketones and total protein: >=2 unit increase from baseline"|Week 4 to Week 16|Safety analysis set with assessments|||participants|||Number
2668121|NCT01508936|Secondary|Participants With Treatment-Emergent Adverse Events|An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Week 28|The safety analysis set includes all patients who took at least 1 dose of study drug, regardless of whether the patients were randomized.|||participants|||Number
2668122|NCT01508936|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12 and 16|The ACQ score was measured using the ACQ-7. Six questions are self-assessments; the seventh item is the result of the patient's % predicted FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A score of 0 indicates good asthma control; higher scores indicate increasingly poorer asthma control. Negative change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12 and 16|Full analysis set. Number of participants analyzed represents # with ACQ baseline values. Number participants with assessments in the timeframes are listed with the time designation. ACQ were excluded if obtained at visits which were preceded by usage within 7 days of a limited subset of medications that could significantly alter interpretation.|||units on a scale||Standard Error|Least Squares Mean
2668123|NCT01508936|Secondary|Change From Baseline in Blood Eosinophil Counts at Weeks 4, 8, 12, 16, Follow-up (Week 28) and Endpoint|Blood eosinophil counts were measured using a standard complete blood count with differential blood test at each scheduled visit. Follow-up was performed approximately 12 weeks after the 16 week treatment period. Endpoint is the last post-baseline assessment.|Baseline (Day 1), Weeks 4, 8, 12, 16, Follow-up (Week 28)|Full analysis set. Number of participants analyzed represents # with blood eosinophil count baseline values. Number participants with assessments in the timeframes are listed with the time designation.|||10^9/liter||Standard Deviation|Mean
2668124|NCT01508936|Secondary|Change From Baseline in Average Daily Use of Short-Acting Beta-Agonist Therapy (SABA) at Weeks 4, 8, 12, and 16|SABA are used for quick relief of asthma symptoms. The number of times SABA therapy was used was assessed using 3 day recall at scheduled visits. Participants were asked to recall whether SABAs were used within 3 days of the scheduled visit and, if so, how many puffs were used. Daily use was the average of those 3 days. Negative change from baseline scores indicate improvement in asthma control.|Baseline (Day -2 to 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with SABA use baseline values. Number participants with assessments in the timeframes are listed with the time designation.|||puffs of SABA/day||Standard Error|Least Squares Mean
2668125|NCT01508936|Secondary|Change From Baseline in the Forced Expiratory Flow at 25% to 75% of the Forced Vital Capacity (FEF25%-75%) at Weeks 4, 8, 12, and 16|The FEF25%-75% is the forced expiratory flow at 25% to 75% of the forced vital capacity. FEF25%-75% was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with FEF25%-75% baseline values. Number of participants with assessments in the timeframes are listed with the time designation.|||liters/second||Standard Error|Least Squares Mean
2668126|NCT01508936|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Weeks 4, 8, 12, and 16|The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters. FV was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with FVC baseline values (one reslizumab participant was missing a valid baseline FVC.) Number participants with assessments in the timeframes are listed with the time designation.|||liters||Standard Error|Least Squares Mean
2668127|NCT01508936|Secondary|Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16 and Endpoint|The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the patient's predicted FEV based on a similar population without asthma. Percent predicted lung function values were transcribed directly from the lung function report to the CRF, without any calculation by Teva. Positive change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with FEV1 baseline values (one reslizumab participant was missing a valid baseline FEV1.) Number participants with assessments in the timeframes are listed with the time designation.|||percentage of predicted FEV1||Standard Deviation|Mean
2668128|NCT01508936|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 4, 8, 12, and 16|FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.|Baseline (Day 1), Weeks 4, 8, 12, and 16|Full analysis set. Number of participants analyzed represents # with FEV1 baseline values (one reslizumab participant was missing a valid baseline FEV1.) Number participants with assessments in the timeframes are listed with the time designation.|||liters||Standard Error|Least Squares Mean
2668138|NCT01508910|Primary|Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol|Baseline (BL) is the average of the two total exercise times measured during the screening period.|Baseline and 12 month visit|Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline.|||seconds||Standard Deviation|Mean
2668139|NCT01508832|Primary|The Change in the Average Finger Temperature From Baseline to Post-intervention.||30 minutes prior and 240 minutes post intervention.|The correspondingly-treated(lidocaine, bupivacaine) finger of all 12 study participants included in analysis for each arm/group|||degrees centigrade||Standard Error|Mean
2668129|NCT01508936|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in FEV1 Subpopulation|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry.~As with the primary outcome, data represent the slope estimate of change from baseline in FEV1 (measured in liters) at Week 16 versus baseline eosinophil count (measured in 10^9/liter) by treatment group. However the FEV1 subpopulation includes participants with more impaired lung function (% predicted FEV1 <85% at baseline)."|Baseline (Day 1), Week 16|The FEV1 sub-population analysis set includes all participants in the FAS with % predicted FEV1 <85% at baseline. Pulmonary function tests were excluded if a limited subset of medications that could significantly confound interpretation were used within 7 days of scheduled visits.|||FEV1 liters/ eosinophils 10^9/liter||Standard Error|Mean
2668130|NCT01508936|Secondary|Change From Baseline in Asthma Control Questionnaire (ACQ) Over 16 Weeks Using Mixed Model for Repeated Measures|"The ACQ score was measured using the ACQ-7. Six questions are-self assessments; the seventh item is the result of the patient's % predicted FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A score of 0 indicates good asthma control; higher scores indicate increasingly poorer asthma control. Negative change from baseline scores indicate improvement in asthma control.~During study (Weeks 4, 8, 12 and 16) average value was calculated from mixed model repeated measures (MMRM) with treatment, visit, treatment by visit interaction, history of asthma exacerbation in the previous year, height, baseline value, and sex as fixed factors, and patient as a random effect."|Baseline (Day 1), Weeks 4, 8, 12, 16|Full analysis set of participants who contributed at least once to the analysis. ACQ were excluded from the FAS if they were obtained at scheduled visits which were preceded by usage within 7 days of a limited subset of medications that could significantly confound interpretation.|||units on a scale||Standard Error|Least Squares Mean
2668131|NCT01508936|Secondary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry. Positive change from baseline scores indicate improvement in asthma control.~During study (Weeks 4, 8, 12 and 16) average value was calculated using a mixed effects model for repeated measures (MMRM) with treatment (reslizumab or placebo), blood eosinophil count at baseline, and the interaction of treatment and eosinophil count as a random effect."|Baseline (Day 1), Weeks 4, 8, 12, 16|Full analysis set (FAS) includes randomized patients treated with at least 1 dose of study drug, and contributed at least once to the analysis. Pulmonary function tests were excluded if a limited subset of medications that could significantly confound interpretation were used within 7 days of scheduled visits.|||liters||Standard Error|Least Squares Mean
2668132|NCT01508936|Primary|Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 16 in Full Analysis Set|"FEV1 is a standard measurement of air movement in the lungs of patients with asthma. It is the volume of air expired in the first second of a forced expiration. Improvement in FEV1 is a measure in the reduction of bronchospasm, the reduction of airway inflammation, or both. FEV1 was measured using forced expiratory air spirometry.~Data represent the slope estimate of change from baseline in FEV1 (measured in liters) at Week 16 versus baseline eosinophil count (measured in 10^9/liter) by treatment group."|Baseline (Day 1), Week 16|Full analysis set (FAS) includes randomized patients treated with at least 1 dose of study drug, and had assessments in the timeframes. Pulmonary function tests were excluded if a limited subset of medications that could significantly confound interpretation were used within 7 days of scheduled visits.|||FEV1 liters/ eosinophils 10^9/liter||Standard Error|Mean
2668133|NCT01508910|Secondary|Percentage of Participants With at Least One Serious Adverse Event (SAE) From Randomization Until the End of the 24 Month Follow-up Period||From randomization until the end of the 24 month follow-up period|Safety Population as Treated.|||percent|||Number
2668134|NCT01508910|Secondary|Percentage of Participants With Incidences of MACE From Randomization Until the End of the 24 Month Follow-up Period|"Major adverse cardiac events (MACE) defined as death, cardiac hospitalization, non-fatal myocardial infarction and stroke, as adjudicated by an independent clinical endpoint classification (CEC) committee.~The category Total MACE includes death, cardiovascular hospitalization, myocardial infarction or stroke."|From randomization until the end of the 24 month follow-up period|Participants in the safety population as Treated.|||percent||95% Confidence Interval|Number
2668135|NCT01508910|Secondary|Angina Frequency (Episodes Per Week) at the 6 Month Follow-up Visit||6 month visit|Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline.|||angina episodes per week||Standard Deviation|Mean
2668136|NCT01508910|Secondary|Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) at the 6 Month Follow-up Visit|Baseline (BL) is the average of the two total exercise times measured during the screening period.|Baseline and 6 month visit|Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline.|||seconds||Standard Deviation|Mean
2668137|NCT01508910|Secondary|Angina Frequency (Episodes Per Week) at the 12 Month Follow-up Visit|Participants self-reported angina episodes utilizing an electronic diary for 4 weeks at baseline (screening period) and in the 4 weeks before the 3, 6 and 12 month follow-up visits.|Baseline and 12 month visit|Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline.|||angina episodes per week||Standard Deviation|Mean
2668140|NCT01508702|Primary|Number of Subjects With an sUA Level That is < 6.0 mg/dL||6 months|ITT Population|||Number of Subjects|Participants||Number
2669102|NCT01498991|Secondary|Timed 10-Meter Walk Test||Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).|The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.||||||
2668141|NCT01508676|Secondary|Clinical Neuropathic Pain Features- Constant Pain and Hypersensitivity After Treatment|"Subjects rated their constant pain and hypersensitivity using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion.~The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study."|2 weeks||||Visual Analog Scale||Standard Deviation|Mean
2668142|NCT01508676|Secondary|Clinical Neuropathic Pain Features- Burning After Treatment|"Subjects rated their burning pain using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion.~The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study."|2 weeks|Only subjects|||Visual Analog Scale||Standard Deviation|Mean
2668143|NCT01508676|Primary|VAS After Treatment|"Subjects rated their pain using the Visual Analog Scale after a 2 week phase of using pennsaid lotion and after a 2 week phase of using placebo lotion.~The Visual Analog Scale is subject reported on a scale of 0-10 with 0 being no pain, and 10 being the worst pain they can imagine. Results reported are an average of reported VAS scores for the 28 subjects who completed both phase I and phase II of the study."|2 weeks.|Only subjects who completed both phases of the crossover study were considered for data analysis.|||Visual Analog Scale||Standard Deviation|Mean
2668144|NCT01508650|Secondary|SPPB (Short Physical Performance Battery)|The SPPB is a multi-component measure of physical function. The SPPB is composed of 3 components—standing balance, gait speed, and timed repeated chair rise—each scored on a scale from 0 to 4 and combined for a total score of 0 to 12. A higher score denotes better physical function.|up to 3 months||||units on a scale||Standard Error|Least Squares Mean
2668145|NCT01508650|Primary|6 Minute Walk Test|The 6 minute walk test submaximal exercise test that measures how far a participant can walk in 6 continuous minutes. Participants are instructed to walk as far as possible in 6 minutes, and are allowed to slow down and take breaks as needed due to symptoms.|up to 3 months||||meters||Standard Error|Least Squares Mean
2668146|NCT01508455|Secondary|Time to Successful Extubation||From the start of study drug infusion to the study completion/withdrawal (Approximately 48 hours)|Subjects who had successful extubation alone (n=5) were included in this analysis.|||Hours||95% Confidence Interval|Median
2668147|NCT01508455|Secondary|Time Spent With a Total N-PASS Score >3 During DEX Infusion|The N-PASS score >3 indicates adequately sedated and not manifesting signs of pain/agitation.|Predose, loading dose (LD) 5 & 10mins/if LD is 20mins (5, 10, 15 & 20mins); maintenance infusion: 0 min, every 15mins (1st hr); every 30mins (2hrs), then hourly; within 5mins of DEX discontinuation; 5mins pre and post rescue medication|All subjects who received DEX for at least 6 hours formed the Efficacy Evaluable Population.|||Hours||Standard Deviation|Mean
2668148|NCT01508455|Secondary|Amount of Rescue Medication for Analgesia During DEX Infusion||During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).|Number of subject who received rescue medication for analgesia during DEX infusion|||mcg/kg|||Number
2668149|NCT01508455|Secondary|Amount of Rescue Medication (Midazolam) for Sedation During Dexmedetomidine Infusion||During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).|No participants analyzed for this assessment since none required rescue Midazolam for sedation.||||||
2668150|NCT01508455|Secondary|Incidence of Rescue Medication (Fentanyl or Morphine) Use for Analgesia During DEX Infusion||During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).|All subjects who received DEX for at least 6 hours formed the Efficacy Evaluable Population.|||participant|||Number
2668151|NCT01508455|Primary|Percent of Subjects Requiring Rescue Midazolam for Sedation||During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).|All Subjects who received study drug for at least 6 hours|||percentage of participants|||Number
2668152|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory 24-hour Heart Rate at Week 12|Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the last 24 hours heart rate at Week 12 and of the baseline heart rate was calculated.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.|||beats/min||Standard Deviation|Mean
2668153|NCT01508325|Secondary|Heart Rate Response Rate|Heart rate response was defined as decrease in heart rate from baseline >=10 percent (%). Heart rate response rate was calculated by using the number of subjects with heart rate response divided by total number of subjects and multiplied by 100.|Week 12|ITT analysis population included all randomized subjects. ‘N’ (number of subjects analyzed) signifies number of evaluable subjects for this outcome measure.|||percentage of subjects|||Number
2668154|NCT01508325|Secondary|Blood Pressure Response Rate|Blood pressure response was defined as DBP less than or equal to (=<) 90 mmHg or >=10 mmHg decrease in DBP from baseline. Blood pressure response rate was calculated as: number of subjects with blood pressure response divided by total number of subjects and multiplied by 100.|Week 12|ITT analysis population included all randomized subjects. ‘N’ (number of subjects analyzed) signifies number of evaluable subjects for this outcome measure.|||percentage of subjects|||Number
2668155|NCT01508325|Secondary|Change From Baseline in 24-hour Blood Pressure Variability at Week 12|The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The mean change in the blood pressure variability between the 24-hour blood pressure observed at Week 12 and baseline was calculated.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.|||mmHg||Standard Deviation|Mean
2668156|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Night-time Heart Rate at Week 12|Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the nighttime heart rate at Week 12 treatment and of the baseline heart rate was calculated to measure the change of mean ambulatory nighttime heart rate at the end of the treatment. Nighttime was defined as 10:00 pm to 06:00 am.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.|||beats/min||Standard Deviation|Mean
2668157|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Daytime Heart Rate at Week 12|Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured daytime heart rate was used as baseline heart rate. The difference between the daytime heart rate at Week 12 treatment and of the baseline heart rate was calculated to measure the change of mean ambulatory daytime heart rate at the end of the treatment. Daytime in this study was defined as 06:00 am to 10:00 pm.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.|||beats/min||Standard Deviation|Mean
2668158|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Night-time Blood Pressure at Week 12|The ABPM determined blood pressure once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first nighttime blood pressure monitoring was used as baseline. The difference between the mean ambulatory nighttime blood pressure observed at Week 12 and baseline was calculated to find out the change of mean ambulatory nighttime blood pressure at the end of the treatment. Nighttime in this study was defined as 10:00 pm to 06:00 am.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.|||mmHg||Standard Deviation|Mean
2668159|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Daytime Blood Pressure at Week 12|The ABPM determined blood pressure 3 times hourly in the daytime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic daytime blood pressure monitoring was used as baseline. The difference between the mean ambulatory daytime blood pressure observed at Week 12 and baseline was calculated to find out the change of mean ambulatory daytime blood pressure at the end of the treatment. Daytime in this study was defined as time between 06:00 am to 10:00 pm.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.|||mmHg||Standard Deviation|Mean
2668160|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory 24-hour Blood Pressure at Week 12|The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ABPM observed in the last 24 hours at Week 12 and baseline was calculated to find out the change of mean ABPM at the end of the treatment.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.|||mmHg||Standard Deviation|Mean
2668161|NCT01508325|Secondary|Change From Baseline in Mean Ambulatory Systolic Blood Pressure (SBP) in the Last 4 Hours After 12-week Treatment|The ABPM determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data >=80% was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ambulatory SBP observed in the last 4 hours after 12-week treatment and baseline was calculated to find out the change of mean ambulatory SBP at the end of the treatment.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.|||mmHg||Standard Deviation|Mean
2668162|NCT01508325|Primary|Change From Baseline in Mean Heart Rate in the Last 4 Hours After 12-week Treatment|Pulse rate was measured by palpation on radial artery for 1 minute. Two measurements were made at least 1 to 2 minutes apart. Finally mean heart rate was recorded. The first measured heart rate was used as baseline heart rate. The difference between the last 4 hours heart rate after 12-week treatment and of the baseline heart rate was calculated to measure the change in mean heart rate at the end of the treatment.|Baseline and Week 12|ITT analysis population included all randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively.|||beats/min||Standard Deviation|Mean
2668163|NCT01508325|Primary|Change From Baseline in Mean Ambulatory Diastolic Blood Pressure (DBP) in the Last 4 Hours After 12-week Treatment|Ambulatory blood pressure monitoring (ABPM) determined blood pressure 3 times hourly in the daytime and once hourly in the nighttime. Only monitoring data with valid data greater than or equal to (>=) 80 percent (%) was used for analysis. Each ABPM lasted for at least 24 hours. The first dynamic blood pressure monitoring was used as baseline. The difference between the mean ambulatory DBP observed in the last 4 hours after 12-week treatment and baseline was calculated to find out the change of mean ambulatory DBP at the end of the treatment.|Baseline and Week 12|ITT analysis population included all the randomized subjects. ‘n’ signifies number of subjects evaluable for this outcome measure at given timepoints for each group, respectively|||mmHg||Standard Deviation|Mean
2668164|NCT01508169|Secondary|Manchester Foot and Pain Disability Index(MFPDI)|"The MFPDI is a test used to assess disability related to foot pain in elderly. It consists of 19 statements prefaced by the phrase Because of pain in my feet…, organized under three constructs: functional limitation (10 items), pain intensity (five items), and personal appearance (two items). For each statement, there are three possible answers: none of the time (score = 0), some days (score = 1), and most days/every day (score = 2). The final score is the sum of all the items and ranges from 0 to 38. The higher score, the greater disability."|4 weeks|A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.|||scores on a scale||Standard Deviation|Mean
2668165|NCT01508169|Secondary|Numeric Pain Scale|Subjects were asked to rate the pain in their feet on a scale from 0 to 10 (0: no pain, 10: extremely severe pain)|4 weeks|A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.|||units on a scale||Standard Deviation|Mean
2668166|NCT01508169|Primary|Timed up and Go Test (TUG)|The TUG test is used to assess the dynamic balance of an individual. It measures the amount of time (recorded in seconds) it takes for the individual to rise from a standard arm chair, walk a distance of 3 meters and return to the initial position resting against the back of the chair.|4 weeks|A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.|||seconds||Standard Deviation|Mean
2668167|NCT01508169|Primary|Berg Balance Scale (BBS)|The BBS is a balance assessment test that rates the ability of a subject to maintain balance while performing each of 14 movements required in everyday activities (transferring, standing unsupported, rising from a sitting to a standing position, tandem standing, turning 360° and single-leg standing). Scoring is based on an ordinal 5-point scale from 0 to 4. Total scores ranges from 0 to 56. The smaller value, the worse balance: from 0-20: a whell chair is needed: 20-41: needing walk assistence; 41-56 - independent walking.|4 weeks|A pilot study (with 14 subjects wearing insoles and 15 controls) was conducted.To identify differences between groups for the variables (Berg, TUG, pain, disability) with a 80% power and a significance level of 5 % the number of 45 subjects in each group was considered satisfactory.|||scores on a scale||Standard Deviation|Mean
2668168|NCT01508130|Secondary|Change From Baseline in Work Loss And Productivity Outcomes (WPAI)|WPAI-AS is a 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Each sub-scores was scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.|Baseline (Day 1 ), Weeks 2, 4, 6, 8, 12, 16, 24, 36, 48, 12 weeks post-treatment|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.|||units on a scale||Standard Error|Least Squares Mean
2668169|NCT01508130|Secondary|Number of Participants With Any AEs and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to 12 weeks post-treatment|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. All 671 participants received at least one dose of study drug; however, 632 of these participants were included in the safety population.|||participants|||Number
2668170|NCT01508130|Secondary|Number of Participants With Premature Treatment Discontinuation Due to Adverse Events (AEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.|Up to 48 weeks|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment.|||participants|||Number
2668171|NCT01508130|Secondary|Number of Participants With Safety-related Dose Reductions|The dose reduction was done because of safety-related reasons (AEs) including alanine aminotransferase disorder, anemia, neutropenia, thrombocytopenia, and rash.|Up to 48 weeks|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment.|||participants|||Number
2668172|NCT01508130|Secondary|Number of Participants Treated With PegIFN, RBV, and BOC as Per the U.S. Label|As per the U.S. labeling, participants with cirrhosis (C); non-cirrhotic/treatment-naïve (NC/TN); and non-cirrhotic/previous partial responders or relapsers (NC/PPR or R) received first 4 weeks of dual therapy, followed by additional 28 or 36 weeks of PegIFN + RBV + BOC (triple therapy) and/or then completed dual therapy through Week 48 depending on viral response and prior response status.|Up to 48 weeks (included 4 weeks of dual therapy + additional 28/36 weeks of triple therapy and/or additional dual therapy up to Week 48)|The safety population was defined as all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.|||participants|||Number
2668173|NCT01508130|Secondary|Number of Participants Treated With PegIFN, RBV, and TEL as Per the U.S. Label|As per the U.S. labeling, participants with treatment-naive, prior relapse (TN-PR) and prior partial or null responder (PP/NR) received PegIFN + RBV + TEL (triple therapy) for 12 weeks; followed additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.|Up to 48 weeks (included 12 weeks of triple therapy + additional 12/36 weeks of dual therapy)|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.|||participants|||Number
2668174|NCT01508130|Secondary|Compliance of Study Treatment|Compliance was assessed based on the number of participants who received the planned study treatment (PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir) during the treatment period.|Weeks 4, 8, 12, and 24|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.|||participants|||Number
2668175|NCT01508130|Secondary|Percentage of Dose Reduction, as Measure of Extent of Exposure to Study Medication|Extent of exposure is defined as the duration of the treatment administered during the study. Degree of dose reduction was calculated as actual exposure/target exposure × 100%. Target exposure was defined as the actual received treatment duration multiplied by the initial assigned dose. Actual exposure was defined as cumulative dose during the treatment period.|From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.|||Percentage of dose reduction||Standard Deviation|Mean
2668176|NCT01508130|Secondary|Mean Cumulative Dose, as Measure of Extent of Exposure to Study Medication|Extent of exposure is defined as the duration of the treatment administered during the study. The mean cumulative doses of PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir were presented.|From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.|||Micrograms||Standard Deviation|Mean
2668177|NCT01508130|Secondary|Treatment Duration, as Measure of Extent of Exposure to Study Medication|Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir is calculated as the number of weeks between the start and end of treatment.|From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)|Safety population: It included all enrolled participants who received at least one dose of study treatment (triple therapy) and had at least one post-baseline safety assessment. “n” denotes number of participants who were available at the indicated time points for each arm.|||Weeks||Standard Error|Mean
2668178|NCT01508130|Secondary|Time to Premature Treatment Discontinuation Due to Intolerance|The participants discontinued the study treatment due to intolerance of the study treatment. Time to premature treatment discontinuation due to intolerance (weeks) = (date of treatment discontinuation due to lack of intolerance - first treatment administration date + 1)/7. Participants who were ongoing or completed the study treatment (including those who shortened the treatment based on response-guided therapy) were censored at the date of their last dosing.|Up to Week 48|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups.|||Weeks||Full Range|Median
2668179|NCT01508130|Secondary|Time to Premature Treatment Discontinuation Due to Lack of Efficacy|The participants discontinued the study treatment due to lack of efficacy of study treatment. Time to premature treatment discontinuation due to lack of efficacy (weeks) = (date of treatment discontinuation due to lack of efficacy - first treatment administration date + 1)/7. Participants who were ongoing or completed the study treatment (including those who shortened the treatment based on response-guided therapy) were censored at the date of their last dosing.|Up to Week 48|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups.|||Weeks||Full Range|Median
2668180|NCT01508130|Secondary|Duration of Viral Undetectability During Treatment for Participants With HCV RNA Undetectable During Treatment by Trial Treatment|The undetectable HCV RNA means HCV RNA values less than 50 IU/mL. This outcome measure was calculated as the duration of participant's first date of undetectable HCV RNA and the date of the participant's last dose.|Up to Week 48|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups.|||weeks||Full Range|Median
2668181|NCT01508130|Secondary|Number of Participants With SVR by Subgroups (Demographic and Baseline Factors)|Participants for VR to prior therapy (PegIFN + RBV) were categorized as: relapse (who completed the previous treatment with HCV RNA undetectable, but relapsed with detectable HCV RNA once treatment was discontinued), breakthrough (HCV RNA undetectable, followed by detectable HCV RNA during on-treatment period), null responder (completed at least 12 weeks of treatment with HCV RNA decrease < 2 log10 at Week 12), partial responder (HCV RNA decrease > 2 log10 by Week 12 of treatment and HCV RNA remained detectable), unknown response (completed previous treatment, but treatment response based on HCV RNA determinations was not available), and prior intolerant (treated previously, but discontinued due to adverse event or participant's choice prior to completion of therapy). Participants categorized into 3 genotypes (CC, CT and TT) based on single nucleotide polymorphism in the Interleukin 28B (IL28B) gene.|Week 12|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.|||participants|||Number
2668182|NCT01508130|Secondary|Predictors of Sustained Virologic Response by Week|SVR rate defined as the number of participants with undetectable HCV RNA (i.e., HCV RNA less than 50 IU/mL) at 12 weeks or later post-completion of the treatment period. The predictors defined as participants with virological response (HCV RNA < 50 IU/mL at any visit), or with virological response at Week 12 (HCV-RNA < 50 IU/mL or unquantifiable or HCV-RNA >=2 log10 drop from baseline). Positive predictive value is the probability that participants with a positive screening test truly have the disease. Negative predictive value is the probability that participants with a negative screening test truly don't have the disease.|Weeks 2, 4, 6, 8, and 12|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.|||participants|||Number
2668226|NCT01507831|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2668183|NCT01508130|Secondary|Number of Participants Who Achieved Extended VR, Virologic Breakthrough/Rebound, Virologic Relapse, and Who Were Non-responder|The extended VR is defined as initial HCV RNA < 50 IU/mL during Weeks 2 to 24 and remaining HCV RNA < 50 IU/mL at all subsequent assessments; virologic breakthrough/rebound is defined as detectable HCV RNA during the treatment period in participants with prior non-detectable HCV RNA or increase of HCV RNA by >=1 log10 above nadir for direct-acting antiviral (DAA) tripe therapies (PegIFN + RBV + TEL or PegIFN + RBV + BOC); virologic relapse is defined as detectable HCV RNA during the treatment-free follow-up period in participants with HCV RNA < 50 IU/mL at EoT; non-responder is defined as participants who never achieved undetectable HCV-RNA during the 48 weeks of treatment.|Up to Week 48|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.|||participants|||Number
2668184|NCT01508130|Secondary|Number of Participants With VR by Categories of Very Rapid VR (VRVR), Rapid Virological Response (RVR), VR Week 8, Early Virological Response (cEVR), Partial Virological Response (pEVR), and None of the Above|VRVR was defined as HCV RNA < 50 IU/mL at treatment Week 2; RVR as HCV RNA < 50 IU/mL by treatment Week 4, but no HCV RNA < 50 IU/mL at Week 2; Week 8 VR as HCV RNA < 50 IU/mL by study Week 8 but no HCV RNA < 50 IU/mL at Weeks 2 to 4; cEVR as HCV RNA < 50 IU/mL by treatment Week 12 but no HCV RNA < 50 IU/mL at Weeks 2 to 8; and pEVR as at least a 2 log10 decrease in HCV RNA by treatment Week 12 but no HCV RNA < 50 IU/mL at Weeks 2 to 12.|Weeks 2, 4, 8, and 12|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.|||participants|||Number
2668185|NCT01508130|Secondary|Number of Participants With Virologic Response (VR)|VR was defined as undetectable HCV RNA (i.e.,HCV RNA less than 50 IU/mL)|Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48; and 12 weeks post-completion of treatment period|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups. “n” denotes number of participants who were available at the indicated time points for each arm.|||participants|||Number
2668186|NCT01508130|Primary|Number of Participants With Sustained Virologic Response (SVR) at 12 Weeks or Later After Completion of the Treatment Period|SVR rate defined as the number of participants with undetectable HCV RNA (i.e., HCV RNA less than 50 IU/mL) at 12 weeks or later post-completion of the treatment period|12 weeks or later post-completion of the treatment period|mTRT population: It included all enrolled participants with HCV RNA of 50 IU/mL or more just prior to start CHC therapy, received 1 triple therapy, and treatment documentation was sufficient for assignment to treatment groups.|||participants|||Number
2668187|NCT01508130|Primary|Time to Premature Treatment Discontinuation Due to Any Reason|Time to premature treatment discontinuation for any reason (weeks) was calculated as follows: date of treatment discontinuation for any reason - first treatment administration date + 1/7. The estimated survivorship curves were obtained from Kaplan-Meier maximum likelihood estimates for each treatment group. Participants who completed the study treatment (including those who shorten the treatment based on response-guided therapy) were censored on their last dosing date.|Up to the treatment discontinuation or the date of the last dosing for participants who were ongoing or completed the study treatment (including those who shorten the treatment based on response-guided therapy)|modified all-treated (mTRT) population: It included all enrolled participants who had an hepatitis C Virus Ribo Nucleic Acid (HCV RNA) of 50 IU/mL or more just prior to start chronic hepatitis C (CHC) therapy, received 1 triple therapy (PegIFN, RBV, and TEL or BOC), and treatment documentation was sufficient for assignment to treatment groups.|||weeks||95% Confidence Interval|Median
2668188|NCT01508117|Primary|Overall Survival||average 1 year||||years|||Number
2668189|NCT01508052|Primary|Core Body Temperature|Core temperature and arteriovenous shunt in the lower leg was measured using oesophageal temperature and the calf-minus-toe skin-surface temperature gradient.|from baseline record core temperature every 15 minutes up to operative end||||degree C||Standard Deviation|Mean
2668190|NCT01508013|Primary|Indoor Tanning Willingness|Scale that measures adolescents willingness to indoor tan in the future. Indoor tanning willingness is measured on a scale that ranges from 1 (definitely not willing; better) to 7 (definitely willing; worse).|12 months|Adolescent females aged 12-18 years old that expressed interest in indoor tanning in the future.|||units on a scale||Standard Deviation|Mean
2668191|NCT01508013|Primary|Indoor Tanning Intentions|A validated measure of the teenagers intentions to use indoor tanning in the next 12 months. Indoor tanning intentions are measured on a scale that ranges from 1 (definitely do not intend to indoor tan; better) to 7 (definitely do intend to indoor tan; worse).|12 months|Adolescent females aged 12-18 years old who expressed interest in indoor tanning in the next year.|||units on a scale||Standard Deviation|Mean
2668192|NCT01508013|Primary|Indoor Tanning Behavior|Self-report measure of the number of times the teenager has indoor tanned over 12 month time period. The self-report measure has been validated in previous studies.|12 months|Adolescent females aged 12-18 years old who expressed interest in indoor tanning in the future.|||Indoor tanning sessions over past year||Standard Deviation|Mean
2668193|NCT01507896|Primary|Incremental Recovery (IR) at 15±5 Minutes Following Loading Dose Prior to Surgery|IR was defined as (C post-infusion - C pre-infusion) / Dose, where C post-infusion is the measured concentration achieved at 15±5 minutes for the loading dose.|Within 60 minutes prior to surgery and 15 ± 5 minutes after loading dose/rebolus, if applicable.|"Participants in the Full Analysis Set (exposed to BAX326 and provided suitable hemostatic efficacy data) who provided data for incremental recovery (IR) after the loading dose prior to surgery.~Note: a unique participant could have more than one surgical procedure."|||[IU/dL] : [IU/kg]|surgeries with IR data|Standard Deviation|Mean
2668227|NCT01507831|Secondary|Percent Change From Baseline in Apo A1 at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo A1 value on- or off-treatment (Apo A1 ITT population).|||percent change||Standard Error|Least Squares Mean
2668194|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Volume of Distribution at Steady State (Vss)|Vss was computed as CL·MRT.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."|||dL/kg|pre-surgical PK assessments|Standard Deviation|Mean
2668195|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Elimination Phase Half-life (T 1/2)|T1/2 was determined as ln2 / λz.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."|||hours (hr)|pre-surgical PK assessments|Standard Deviation|Mean
2668196|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Incremental Recovery (IR) at 30 Min|IR was defined as (C post-infusion - C pre-infusion) / Dose, where C post-infusion is the measured concentration achieved at 30±5 minutes for pre-surgical PK.|Within 30 mins pre-infusion and post-infusion at 30 minutes|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."|||IU/dL : IU/kg|pre-surgical PK assessments|Standard Deviation|Mean
2668197|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Factor IX (FIX) Clearance (CL)|CL is the volume of plasma which is completely cleared of study product per unit time and is calculated as the dose divided by the total area under the curve from 0 to infinity (AUC0-inf).|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."|||dL/(kg•hr)|pre-surgical PK assessments|Standard Deviation|Mean
2668198|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Mean Residence Time (MRT)|The MRT is the average time that the study product stays in the body (or plasma) and is calculated as: AUMC 0-inf / AUC 0-inf, where AUMC 0-inf was determined in a similar manner as AUC 0-inf.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."|||hours (hr)|pre-surgical PK assessments|Standard Deviation|Mean
2668199|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Total Area Under the Plasma Concentration Versus Time Curve Per Dose (Total AUC/Dose)|Total AUC/Dose is also AUC0-inf (area under the plasma concentration/time curve from time 0 to infinity) and was defined as AUC0-t + Ct / λz, where t is the time of last quantifiable concentration, Ct is the last quantifiable concentration and λz is the terminal rate constant.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."|||[IU•hour (hr)/dL] : IU/kg|pre-surgical PK assessments|Standard Deviation|Mean
2668200|NCT01507896|Primary|Pre-Surgical Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 72 Hours Post-infusion Per Dose|AUC0-72h (area under the plasma concentration/time curve from time 0 to 72 hours) was computed using the linear trapezoidal method. The concentration at 72 hours was interpolated from the two nearest sampling time points or extrapolated using the last quantifiable concentration and the terminal rate constant λz. λz was estimated from the slope of natural log-linear fitting to latter quantifiable concentrations, with largest adjusted R2.|Within 30 mins pre-infusion and post-infusion timepoints of 30 minutes, 6 hr, 24 hr, 48 hr and 72 hr|"Participants in the Full Analysis Set (exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who underwent a pre-surgical PK assessment in this study i.e.not participants who underwent a PK assessment in the pivotal study (250901).~Note: a unique participant could have a pre-surgical PK assessment for more than one surgery."|||[IU•hour (hr)/dL] : IU/kg|pre-surgical PK assessments|Standard Deviation|Mean
2668201|NCT01507896|Primary|Safety: Occurence of a Thrombotic Event||Throughout the study period (approximately 2 years 5 months)|"All participants in the Safety Analysis Set (participants exposed to BAX326 during the study).~Note: a unique participant could be treated with BAX326 for more than one surgical procedure."|||surgeries|treatments with BAX326 before surgery||Number
2668202|NCT01507896|Primary|Safety: Number of Adverse Events Related to BAX326||Throughout the study period (approximately 2 years 5 months)|"All participants in the Safety Analysis Set (participants exposed to BAX326 during the study).~Note: a unique participant could be treated with BAX326 for more than one surgical procedure."|||adverse events|treatments with BAX326 before surgery||Number
2668203|NCT01507896|Primary|Safety: Number of Participants Who Developed Total Binding Antibodies to Factor IX (FIX)|If there was more than 2-dilution increase as compared to pre-study level at screening.|Throughout the study period (approximately 2 years 5 months)|"All participants in the Safety Analysis Set (participants exposed to BAX326 during the study).~Note: a unique participant could be treated with BAX326 for more than one surgical procedure."|||participants|treatments with BAX326 before surgery||Number
2668204|NCT01507896|Primary|Safety: Number of Participants Who Developed Inhibitory Antibodies to Factor IX (FIX)||Throughout the study period (approximately 2 years 5 months)|"All participants in the Safety Analysis Set (participants exposed to BAX326 during the study).~Note: a unique participant could be treated with BAX326 for more than one surgical procedure."|||participants|treatments with BAX326 before surgery||Number
2668205|NCT01507896|Primary|Volume of Blood Product Transfused|Blood product transfusions consisted of packed red blood cells (PRBC) or fresh frozen plasma (FFP) or both.|From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"Participants in the Full Analysis Set (exposed to BAX326 and provided suitable hemostatic efficacy data) who received blood product infusions during the intraoperative and/or postoperative period.~Note: a unique participant could have more than one surgical procedure."|||mL|surgery where blood transfusion given|Standard Deviation|Mean
2668206|NCT01507896|Primary|Number of Units of Blood Product Transfused|Blood product transfusions consisted of packed red blood cells (PRBC) or fresh frozen plasma (FFP) or both.|From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"Participants in the Full Analysis Set (exposed to BAX326 and provided suitable hemostatic efficacy data) who received blood product infusions during the intraoperative and/or postoperative period.~Note: a unique participant could have more than one surgical procedure."|||units|surgery where blood transfusion given|Standard Deviation|Mean
2668207|NCT01507896|Primary|Total Weight-Adjusted Dose of BAX326 Per Participant|Assessed for the intra- and postoperative periods.|From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.~Note: a unique participant could have more than one surgical procedure."|||IU/kg|surgeries|Standard Deviation|Mean
2668208|NCT01507896|Primary|Daily Weight-Adjusted Dose of BAX326 Per Participant|"Daily weight-adjusted doses of BAX326 per participant were recorded from the day of surgery until postoperative Days 11+.~Each category in outcome measure includes number of all, major and minor surgeries, respectively, if different from the totals."|From initiation of surgery until discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.~Note: a unique participant could have more than one surgical procedure."|||IU/kg|surgeries|Standard Deviation|Mean
2668209|NCT01507896|Primary|Actual Postoperative Blood Loss Compared to Average and Maximum Blood Loss Predicated Preoperatively by the Operating Surgeon|"Predicted average/maximum blood loss minus actual blood loss for participants who had a drain placed during surgery.~Prior to the surgery, the surgeon will predict the estimated volume (mL) of the expected average and maximum blood loss for the planned surgical intervention in a hemostatically normal individual of the same sex, age, and stature as the study subject for the postoperative period until drain removal."|At postoperative day 3 (approximately 72 hours postoperatively)|"Participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who had a drain placed during surgery (major surgeries only).~Note: a unique participant could have more than one surgical procedure."|||mL|surgeries with drain placed|Standard Deviation|Mean
2668210|NCT01507896|Primary|Actual Postoperative Blood Loss|Postoperative blood loss was based on the drainage fluid and was only assessed for participants who had a drain placed during surgery.|At drain removal (from 1-3 days postoperatively)|"Participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who had a drain placed during surgery (major surgeries only).~Note: a unique participant could have more than one surgical procedure."|||mL|surgeries with drain placed|Standard Deviation|Mean
2668211|NCT01507896|Primary|Postoperative Hemostatic Efficacy on Day of Discharge|"Assessment by the operating surgeon on a 4 point ordinal scale:~Excellent: Postoperative hemostasis achieved with BAX326 was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal participant~Good: Postoperative hemostasis achieved with BAX326 was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal participant~Fair: Postoperative hemostasis with BAX326 was clearly less than optimal for the type of procedure performed but was maintained without the need to change the Factor IX concentrate~None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate"|At discharge from hospital (from 1-3 days postoperatively for minor surgery and approximately 2 weeks postoperatively for major surgery)|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.~Note: a unique participant could have more than one surgical procedure."|||surgeries|surgeries||Number
2668212|NCT01507896|Primary|Postoperative Hemostatic Efficacy at Postoperative Day 3|"Assessment by the operating surgeon on a 4 point ordinal scale:~Excellent: Postoperative hemostasis achieved with BAX326 was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal participant~Good: Postoperative hemostasis achieved with BAX326 was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal participant~Fair: Postoperative hemostasis with BAX326 was clearly less than optimal for the type of procedure performed but was maintained without the need to change the Factor IX concentrate~None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate"|At postoperative day 3 (approximately 72 hours postoperatively)|"Participants in the Full Analysis Set who were provided with a hemostatic efficacy assessment by the operating surgeon at post operative day 3 where no drain was employed.~Note: a unique participant could have more than one surgical procedure."|||surgeries|surgeries||Number
2668228|NCT01507831|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2668229|NCT01507831|Secondary|Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2668213|NCT01507896|Primary|Postoperative Hemostatic Efficacy at Drain Removal|"The postoperative hemostatic efficacy was to be assessed by the operating surgeon according to the following criteria (4-point ordinal scale):~Excellent: Volume in drain was less than or equal than that expected for the type of procedure performed in a hemostatically normal participant (≤ 100% )~Good: Volume in drain was up to 50% more than expected for the type of procedure performed in a hemostatically normal participant (101% - 150%)~Fair: Volume in drain was more than 50% of that expected for the type of procedure performed in a hemostatically normal participant (> 150%)~None: Uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate"|At drain removal (from 1-3 days postoperatively)|"Participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) who had a drain placed during surgery (major surgeries only).~Note: a unique participant could have more than one surgical procedure"|||major surgeries with drain placed|major surgeries with drain placed||Number
2668214|NCT01507896|Primary|Actual Intraoperative Blood Loss Compared to Average and Maximum Blood Loss Predicted Preoperatively by the Operating Surgeon|Predicted average/maximum blood loss minus actual blood loss. Prior to the surgery, the surgeon predicted the estimated volume (mL) of the expected average and maximum blood loss for the planned surgical intervention in a hemostatically normal individual of the same sex, age, and stature as the study participant for the intraoperative period.|On day of surgery|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.~Note: a unique participant could have more than one surgical procedure."|||mL|surgeries|Standard Deviation|Mean
2668215|NCT01507896|Primary|Actual Intraoperative Blood Loss|Actual intraoperative blood loss was determined by the drainage volume, if a drain was placed, and the estimated blood loss into swabs and towels during the procedure.|On day of surgery|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 per surgical procedure.~Note: a unique participant could have more than one surgical procedure."|||mL|surgeries|Standard Deviation|Mean
2668216|NCT01507896|Primary|Intraoperative Hemostatic Efficacy|"Assessment by the operating surgeon on a 4 point ordinal scale (according to the definitions provided below):~Excellent: Intraoperative blood loss was less than or equal to that expected for the type of procedure performed in a hemostatically normal participant (≤ 100% )~Good: Intraoperative blood loss was up to 50% more than expected for the type of procedure performed in a hemostatically normal participant (101 - 150%)~Fair: Intraoperative blood loss was more than 50% of that expected for the type of procedure performed in a hemostatically normal participant (> 150%)~None: Uncontrolled hemorrhage that was the result of inadequate therapeutic response despite proper dosing, necessitating a change of Factor IX concentrate"|On day of surgery|"All participants in the Full Analysis Set (participants exposed to BAX326 and provided data suitable for hemostatic efficacy analysis) treated with BAX326 and had surgery.~Note: a unique participant could have more than one surgical procedure."|||surgeries|surgeries||Number
2668217|NCT01507831|Post-Hoc|Percentage of Participants Who Experienced Major Adverse CV Events|Major adverse CV events were defined as all adverse CV events except Congestive heart failure (CHF) requiring hospitalization; and ischemia-driven coronary revascularization procedure.|Up to 10 weeks after last study drug administration (maximum of 86 weeks)|Safety population.|||percentage of participants|||Number
2668218|NCT01507831|Other Pre-specified|Percentage of Participants Who Experienced Cardiovascular (CV) Events|CV events included coronary heart disease (CHD) death; non-fatal myocardial infarction (MI); fatal and non-fatal ischemic stroke; unstable angina requiring hospitalization; congestive heart failure (CHF) requiring hospitalization; ischemia-driven coronary revascularization procedure. Reported events are CV events as confirmed by an independent Clinical Events Committee (CEC) that occurred during the treatment emergent period ( i.e. from first dose up to the last dose of study drug + 70 days).|Up to 10 weeks after last study drug administration (maximum of 86 weeks)|Safety population.|||percentage of participants|||Number
2668219|NCT01507831|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 78 (i.e. up to 21 days after last injection).|From Baseline to Week 78|mITT population.|||percent change||Standard Error|Least Squares Mean
2668220|NCT01507831|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis|Adjusted LS means and standard errors at Week 78 from MMRM model including all available post-baseline data from Week 4 to Week 78 regardless of status on- or off-treatment.|From Baseline to Week 78|ITT population.|||percent change||Standard Error|Least Squares Mean
2668221|NCT01507831|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|mITT population.|||percent change||Standard Error|Least Squares Mean
2668222|NCT01507831|Other Pre-specified|Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis|Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Least Squares Mean
2668223|NCT01507831|Secondary|Percent Change From Baseline in Apo A1 at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo A1 ITT population.|||percent change||Standard Error|Least Squares Mean
2668224|NCT01507831|Secondary|Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis|Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2668225|NCT01507831|Secondary|Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2668230|NCT01507831|Secondary|Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis|Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment were included in the imputation model.|From Baseline to Week 52|ITT population.|||percent change||Standard Error|Mean
2668231|NCT01507831|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|Up to Week 52|mITT population.|||percentage of participants|||Number
2668232|NCT01507831|Secondary|Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis|Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.|Up to Week 52|ITT population.|||percentage of participants|||Number
2668233|NCT01507831|Secondary|Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis|Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|Up to Week 52|mITT population.|||percentage of participants|||Number
2668234|NCT01507831|Secondary|Percentage of Very High Cardiovascular (CV) Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis|Very high CV risk: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents or non- Familial Hypercholesterolemia (FH). High CV risk: heFH participants without CHD or CHD risk equivalents. CHD risk equivalent: peripheral arterial disease, ischemic stroke, moderate chronic kidney disease (estimated glomerular filtration rate, 30 to <60 ml/minute/1.73 m^2 of body-surface area), or diabetes mellitus plus 2 or more additional risk factors (hypertension; ankle-brachial index of ≤0.90; microalbuminuria, macroalbuminuria, or a urinary dipstick result of >2+ protein; preproliferative or proliferative retinopathy or laser treatment for retinopathy; or family history of premature CHD). Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in imputation model.|Up to Week 52|ITT population.|||percentage of participants|||Number
2668235|NCT01507831|Secondary|Percent Change From Baseline in Total-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Total-C ITT population.|||percent change||Standard Error|Least Squares Mean
2668236|NCT01507831|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Non-HDL-C ITT population.|||percent change||Standard Error|Least Squares Mean
2668237|NCT01507831|Secondary|Percent Change From Baseline in Apo B at Week 12 - ITT Analysis|Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Apo B ITT population.|||percent change||Standard Error|Least Squares Mean
2668238|NCT01507831|Secondary|Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).|||percent change||Standard Error|Least Squares Mean
2668239|NCT01507831|Secondary|Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).|||percent change||Standard Error|Least Squares Mean
2668240|NCT01507831|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).|||percent change||Standard Error|Least Squares Mean
2668241|NCT01507831|Secondary|Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).|From Baseline to Week 52|Participants of the mITT population with one baseline and at least one post-baseline Apo-B value on-treatment (Apo B mITT population).|||percent change||Standard Error|Least Squares Mean
2668242|NCT01507831|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis|Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).|||percent change||Standard Error|Least Squares Mean
2668243|NCT01507831|Secondary|Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis|Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.|From Baseline to Week 52|Participants of the ITT population with one baseline and at least one post-baseline measured LDL-C value on- or off-treatment.|||percent change||Standard Error|Least Squares Mean
2668246|NCT01507831|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis|Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).|From Baseline to Week 52|Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.|||percent change||Standard Error|Least Squares Mean
2668247|NCT01507831|Secondary|Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis|Adjusted least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).|From Baseline to Week 52|ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on­ or off-treatment.|||percent change||Standard Error|Least Squares Mean
2668248|NCT01507831|Primary|Percentage of Participants Who Experienced Adverse Events (AEs)|Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days).|Up to 10 weeks after last study drug administration (maximum of 86 weeks)|Safety population: all randomized participants who received at least one dose or part of a dose of a study drug (treated).|||percentage of participants|||Number
2668249|NCT01507779|Secondary|Number and Percentage of Subjects Developing a Seroprotective Microneutralizing (MN) Antibody Titer|Seroprotection defined as an antibody titer of 1:40 or greater. Day 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale.|Day 21 and Day 42|Includes subjects who had a baseline titer of <1:40.|||Participants|||Count of Participants
2668250|NCT01507779|Secondary|Number and Percentage of Subjects Achieving a Four-fold Rise in Microneutralizing (MN) Antibodies Among Subjects With Baseline Titer Greater Than 40|Day 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale.|Day 21 and Day 42|Subjects with baseline titer >=40|||Participants|||Count of Participants
2668251|NCT01507779|Secondary|Number and Percentage of Subjects Achieving a Four-fold Rise in Microneutralizing (MN) Antibodies Among Subjects With Baseline Titer Less Than 40|Day 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells.|Day 21 and Day 42|Subjects with baseline titer <40|||Participants|||Count of Participants
2668252|NCT01507779|Secondary|Number and Percentage of All Subjects Achieving a Four-fold Rise in Microneutralization (MN) Antibodies|Day 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale.|Day 21 and Day 42||||Participants|||Count of Participants
2668253|NCT01507779|Secondary|Ratio of Geometric Mean Titer of Microneutralization (MN) Antibodies|Day 0, 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale.|Day 0, Day 21 and Day 42||||ratio||95% Confidence Interval|Geometric Mean
2668254|NCT01507779|Secondary|Geometric Mean Titer of Microneutralizing (MN) Antibodies|Day 0, 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale.|Day 0, Day 21 and Day 42||||titer||95% Confidence Interval|Geometric Mean
2668255|NCT01507779|Secondary|Number and Percentage of Subjects Developing a Seroprotective Hemagglutination-inhibition (HAI) Antibody Titer|Seroprotection defined as an HAI titer ≥1:40. Day 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells.|Day 21 and Day 42|Includes subjects who had a baseline titer of <1:40.|||Participants|||Count of Participants
2668256|NCT01507779|Secondary|Number and Percentage of Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI) Among Subjects With Baseline Titer Greater Than 40|Day 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells.|Day 21 and Day 42|Subjects with baseline titer >=40|||Participants|||Count of Participants
2668285|NCT01507220|Secondary|Patient Satisfaction With Postsurgical Analgesia|Responses to one question pertaining to patient satisfaction with postsurgical pain management and four questions pertaining to postsurgical recovery following hospital discharge.|From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), whichever is sooner|As no subjects received EXPAREL in this study, statistical analyses were not performed.||||||
2668257|NCT01507779|Secondary|Number and Percentage of Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI) Among Subjects With Baseline Titer Less Than 40|Day 21 and Day 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells.|Day 21 and Day 42|Subjects with baseline titer <40|||Participants|||Count of Participants
2668258|NCT01507779|Secondary|Number and Percentage of All Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI)|Day 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells.|Day 21 and Day 42||||Participants|||Count of Participants
2668259|NCT01507779|Secondary|Ratio of Geometric Mean Titer of Hemagglutination-inhibition Antibodies (HAI)|Day 0, 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells.|Day 0, Day 21 and Day 42||||ratio||95% Confidence Interval|Geometric Mean
2668260|NCT01507779|Secondary|Geometric Mean Titer of Hemagglutination-inhibition Antibodies (HAI)|Day 0, 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells.|Day 0, Day 21 and Day 42||||titer||95% Confidence Interval|Geometric Mean
2668261|NCT01507779|Primary|Unsolicited, Non-serious Adverse Events|Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Adverse events were collected throughout the study period, and were graded for severity; however unsolicited adverse events were assessed only for relationship to vaccine if the events were immediate reactions or considered to be serious adverse events.|7 days after each dose (Day 7 and Day 28)||||adverse events|||Number
2668262|NCT01507779|Primary|Number of Participants With Maximum Local Reaction After Vaccination 2|Systemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness.|7 days||||Participants|||Count of Participants
2668263|NCT01507779|Primary|Number of Participants With Maximum Local Reaction After Vaccination 1|Systemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness.|7 days||||Participants|||Count of Participants
2668264|NCT01507779|Primary|Number of Participants With Maximum Systemic Reaction After Vaccination 2|Systemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited systemic reactogenicity events included body temperature, feverishness, chills, cough, difficulty breathing, runny nose, nasal congestion, sore throat, hoarseness of voice, headache, confusion, convulsions/seizures, fatigue/malaise, muscle aches, joint pain, pink or red eyes, sore eyes, itchy eyes, drainage from eyes, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting and jaundice. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness.|7 days||||Participants|||Count of Participants
2668265|NCT01507779|Primary|Number of Participants With Maximum Systemic Reaction After Vaccination 1|Systemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited systemic reactogenicity events included body temperature, feverishness, chills, cough, difficulty breathing, runny nose, nasal congestion, sore throat, hoarseness of voice, headache, confusion, convulsions/seizures, fatigue/malaise, muscle aches, joint pain, pink or red eyes, sore eyes, itchy eyes, drainage from eyes, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting and jaundice. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness.|7 days||||Participants|||Count of Participants
2668266|NCT01507688|Primary|Total Stroke Specific Quality of Life|A 49-item instrument that assesses 12 domains relevant to stroke patients' health-related quality of life including: energy, mobility, work, upper extremity function, activities of daily living, family roles, social roles, vision, language, thinking, mood, and personality. A lower score indicates poorer functioning and a higher score indicates better functioning. The minimum value was 1 and maximum value was 5. A Total Stroke Specific Quality of Life Score was calculated as the mean of the 49-items.|Change from baseline to 6 months|Participants were patients discharged with an acute stroke or TIA as the primary diagnoses.|||units on a scale||Standard Deviation|Mean
2668282|NCT01507233|Secondary|Incidence of Opioid-related Adverse Events and Patient Satisfaction With Postsurgical Analgesia.|"Incidence of opioid-related adverse events defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.~Responses to one question pertaining to patient satisfaction with postsurgical analgesia and four questions pertaining to postsurgical recovery following hospital discharge."|Wound closure to time hospital discharge order written or Day 30, whichever is sooner.|As no subjects received EXPAREL in this study, statistical analyses were not performed.||||||
2668315|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Slope)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1||||unitless||95% Confidence Interval|Number
2668267|NCT01507662|Primary|Guideline Concordant Osteoporosis Therapy|Guideline concordant was defined as those who prescribed a National Osteoporosis Foundation approved osteoporosis therapy for patients with osteoporosis (T-score of femoral neck, hip, or spine ≤−2.5 or FRAX ≥20 %), or patients with a self-reported history of low impact fracture, or patients with osteopenia (T-score between −1.0 and −2.5 at the femoral neck, hips, or lumbar spine) and a 10-year probability of a major osteoporosis-related fracture ≥20 % OR those who were not prescribed a therapy for patients with no self-reported history of prior DXA and study DXA shows normal BMD and no self-reported history of low impact fracture, or study DXA shows osteopenia (T-score of femoral neck, hip, or spine between −1 and −2.5) and FRAX <20 %) and no self-reported history of low impact fracture, or self-reported prior DXA but no self-reported history of low impact fracture and no self-reported history of osteoporosis.|12 weeks after DXA||||Participants|||Count of Participants
2668268|NCT01507584|Secondary|Ocular Adverse Events|appearance of any device- or non-device-related ocular adverse events|24-hours|The PI has left the institution and the study data can not be located. Multiple attempts where made to reach the study team, so there are no results to report.||||||
2668269|NCT01507584|Primary|Intraocular Pressure|IOP monitoring sessions will be carried out in ambulatory mode at 4 week intervals (plus/minus 7 days)|24-hours|The PI has left the institution and the study data can not be located. Multiple attempts where made to reach the study team, so there are no results to report.||||||
2668270|NCT01507584|Primary|24-hour IOP Patterns|Assess IOP patterns between day and night time and changes after the WDT.|24-hour|The PI has left the institution and the study data can not be located. Multiple attempts where made to reach the study team, so there are no results to report.||||||
2668271|NCT01507493|Secondary|Preoperative Pressure Pain Tolerance (PTO)|"The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say ok when they started to feel the pain became intolerable during the stimulation. The value from the LCD was recorded as the pressure pain tolerance."|12 hours before the operation||||kg/cm2||Standard Deviation|Mean
2668272|NCT01507493|Primary|PCA Press Frequency 48h After Operation.||48 hours after the operation||||presses per day||Standard Deviation|Mean
2668273|NCT01507493|Secondary|Preoperative Pressure Pain Threshold (PPT)|"The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say pain when they started to feel pain during the stimulation. The value from the LCD was recorded as the pressure pain threshold."|12 hours before the operation||||kg/cm2||Standard Deviation|Mean
2668274|NCT01507493|Secondary|The Visual Analog Scale 48h After Operation.|The visual analog scale (VAS) is used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 48h after operation. And the visual analog scale is from 0 to 10 which 0 represent no pain while 10 represent unbearable pain|48 hours after the operation||||units on a scale||Standard Deviation|Mean
2668275|NCT01507493|Primary|Opioid Consumption Dose 48h After Operation.||48 hours after the operation||||microgramme||Standard Deviation|Mean
2668276|NCT01507298|Secondary|Change in Relative Intensity of Daily Activities (%)|"Measuring the changes in restful (activity equivalent to sitting), low (activity equivalent to a slow walk), moderate (activity equivalent to a brisk walk) and high intensity activity (activity equivalent to running).~Including subject-specific activity intensity quartiles, were calculated and compared."|Difference between baseline (2 days average) and test day (during pH monitoring)|Raw data captured for capsule endoscopy group not analysed to produce activity metrics due to insufficient numbers recruited (i.e. 1 subject).|||Percentage change in activity||Standard Deviation|Mean
2668277|NCT01507298|Primary|Physical Activity Change (%)|"The primary outcome measure is amount of physical activity undertaken by participants throughout the study period. Participant motion data will be collected using a tri-axial accelerometer in the eAR sensor. Signal processing methods will be used to produce an activity index in the form of a numerical value, from the raw data.~Activity levels were grouped at 1- minute intervals into restful, low, moderate or high intensity activity.~Activity levels were calibrated for each participant, classifying activity into quartiles, where the most inactivity was labelled 'Restful', 2nd quartile 'low intensity', 3rd quartile 'moderate intensity' and upper quartile 'high intensity'. This provided a personalised activity profile with which to compare activity during the investigation."|Difference between baseline (2 days average) and test day (during pH monitoring)|Due to significant differences in expected and actual recruitment for the capsule endoscopy arm (i.e. 1 subject), raw data collected were not analysed to produce activity metrics.|||Percentage change in activity||Standard Deviation|Mean
2668278|NCT01507246|Primary|Health Economic Benefits - Length of Stay|Length of stay (LOS), recorded in hours and converted to days with one decimal of precision, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.|Up to Day 30|All subjects analyzed, no censored events|||days||Inter-Quartile Range|Median
2668279|NCT01507246|Secondary|Incidence of Predefined Opioid-related Adverse Events|The incidence of predefined opioid-related adverse events|From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), which ever is sooner|Per protocol.|||Number of patients|||Number
2668280|NCT01507246|Primary|Health Economic Benefits - Total Cost of Hospitalization|Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order written or Day 30, whichever is sooner.|per protocol|||dollars||Standard Deviation|Mean
2668281|NCT01507246|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order written or Day 30, whichever is sooner|Per protocol|||mg||Standard Deviation|Mean
2668283|NCT01507233|Primary|Health Economic Benefits|"Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.~Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner."|Wound closure to Day 30|As no subjects received EXPAREL in this study, statistical analyses were not performed.||||||
2668286|NCT01507220|Secondary|Incidence of Opioid-related Adverse Events|"Incidence of opioid-related adverse events is defined as somnolence, respiratory depression, hypoventilation, hypoxia, dry mouth, nausea, vomiting, constipation, sedation, confusion, pruritus, urinary retention, and postoperative ileus.~."|From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), whichever is sooner|As no subjects received EXPAREL in this study, statistical analyses were not performed.|||Adverse events|||Number
2668287|NCT01507220|Primary|Health Economic Benefit|"Total cost of hospitalization to time hospital discharge order is written or through Day 30, whichever is sooner.~Length of stay (LOS), recorded in hours, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner."|Wound closure to time hospital discharge order written or Day 30, whichever is sooner.|As no subjects received EXPAREL in this study, statistical analyses were not performed.||||||
2668288|NCT01507220|Primary|Total Opioid Burden|Total opioid consumed (IV and PO) postsurgically until the hospital discharge order is written or through Day 30, whichever is sooner.|Wound closure to time hospital discharge order written or Day 30, whichever is sooner|As no subjects received EXPAREL in this study, statistical analyses were not performed.||||||
2668289|NCT01507181|Secondary|Patient Rated Inventory of Side Effects (PRISE)|The PRISE assesses the presence of treatment side effects in nine organ/function systems (gastrointestinal, nervous system, heart, eyes/ears, skin, genital/urinary, sleep, sexual functioning, and other). Data reported in in Adverse Events section.|duration of study||||events|||Number
2668290|NCT01507181|Secondary|The Clinician-Administered Dissociative States Scale (CADSS)|The CADSS measures dissociation with higher scores indicating more severe symptoms (scale range 0 - 92).|baseline, 40 minutes post infusion and 240 minutes post infusion||||units on a scale||Standard Deviation|Mean
2668291|NCT01507181|Secondary|The Brief Psychiatric Rating Scale (BPRS)|The BPRS measures psychomimetic effects with higher scores indicating more severe symptoms (scale range 7 - 49).|baseline, 40 minutes post infusion, and 240 minutes post infusion||||units on a scale||Standard Deviation|Mean
2668292|NCT01507181|Secondary|The Young Mania Rating Scale (YMRS)|An 11-item questionnaire, used to assess manic symptoms based on the patient's subjective report of his or her clinical condition. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. The scores from each question are added together to form a total score ranging from 0 to 60, with higher scores indicating a greater severity of symptoms.|baseline, 40 minutes post infusion, 240 minutes post infusion||||units on a scale||Standard Deviation|Mean
2668293|NCT01507181|Secondary|Suicidality Item of the MADRS (MADRS-SI)|The MADRS-SI ranges from 0 to 6; a score of 2 corresponds to fleeting, passive SI; a score of 4 indicates that SI is frequent with at least moderate intensity but without specific plans or intention; a score of 6 corresponds to active intention and planning for suicide.|24 hours post infusion||||units on a scale||Standard Deviation|Mean
2668294|NCT01507181|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.|up to 7 days post infusion||||units on a scale||Standard Deviation|Mean
2668295|NCT01507181|Primary|Change in Beck Scale for Suicidal Ideation (BSSI)|Change in BSI score at 48 hours following treatment as compared to baseline. Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.|baseline and 48 hours post infusion||||units on a scale||Standard Deviation|Mean
2668296|NCT01507181|Primary|Change in Beck Scale for Suicidal Ideation (BSSI)|Change in BSI score at 24 hours following treatment as compared to baseline. Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.|baseline and 24 hours post infusion||||units on a scale||Standard Deviation|Mean
2668297|NCT01507155|Secondary|Efficacy Measured by QIDS-SR16, Q-LES-Q-SF, UKU Side Effects; and SAS at 3 Months|"To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity as measured by change from baseline in self-reported patients scales:~Quick Inventory of Depressive Symptoms (QIDS-SR16) scale; scores range from 0-27, 0 means no depression and 27 means very severe depression~Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) scale; scores range from 0-100 and greater scores correspond with greater satisfaction with quality of life~Undersøgelser (UKU) scale that measures degree of side effects from total scores ranging from 0-100; 0-40 refers to low side effects and 81-100 referring to high side effects rating~the Zung Self-Rated Anxiety (SAS) scale measures anxiety severity using the total scores ranging from 20-80; 20-44 being normal and 75-80 meaning most severe"|3 months|Only 197 patients completed self-assessments at 3 months.|||Scores on a scale||Standard Deviation|Mean
2668298|NCT01507155|Primary|Change From Baseline in Clinical Global Impressions Improvement (CGI-I) Scale at 3 Months|To determine the efficacy of assay-guided treatment (AGT) in terms of illness severity, as measured by change from baseline using the clinician-administered CGI-I scale, which ranges from scores 1-7 (1=very much improved, 7=very much worse since initiation of treatment).|3 months||||Participants|||Number
2668299|NCT01507103|Primary|Change From Baseline in IFN-gamma Secretion of Mononuclear Cells in Response to Carcinoembryonic Antigen (CEA) by ELISpot at Post-baseline|IFN-gamma secretion of mononuclear cells in response to CEA was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.|Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)|Data were not analyzed as no acceptable ELISpot assay is available||||||
2668316|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Intercept)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1||||kilograms||95% Confidence Interval|Number
2668317|NCT01507090|Secondary|Device Print Batch Variability|"Geometric mean of the ratio (CV) of true to estimated weight calculated by TAPE version. Mercy TAPEs were printed in 2 batches numbers 1 and 2 accordingly."|study day 1||||ratio||Geometric Coefficient of Variation|Geometric Mean
2668300|NCT01507103|Secondary|Change From Baseline in Immunological Response in Peripheral Blood at Week 18 (Follow-up / end-of Trial)|Immunological changes in peripheral blood were evaluated based on fluorescence analysis cell sorter phenotypic characterization of T cells (CD3+CD4+ and CD3+CD8+) and of markers of activation and proliferation (CD27, BTLA); and regulatory cells such as CD3+CD4+ (or CD8+) CD45RA+CD25+FoxP3+CD127 T cells. Immunological Response in peripheral blood was measured on a continuous scale.|Baseline and Week 18 (follow-up / end-of trial)|Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive. Within the data table, n=number of subjects analysed for each category.|||log2 (percentage of T cells)||Standard Deviation|Mean
2668301|NCT01507103|Secondary|Change From Baseline in Peritumoral Immune Response at Week 14 (Post-surgery)|Immunological changes in the tumor microenvironment were evaluated based on IHC expression of CD3+, CD4+, and Ki67+CD3+ T cells; regulatory T cells (FOXP3+) and myeloid-derived suppressor cells (CD33+CD14-); other immune cells such as NK cells (CD3-CD57+), B cells (CD20+), macrophages (CD68+), and dendritic cells (S100+). Peritumoral immune response was calculated as number of lymphoid cells at the margin of the tumor or in the tumor bed (if there is complete pathological response).|Baseline and Week 14 (post-surgery)|The pre-specified statistical threshold for reporting of results of planned analysis for either arm or interaction effect was not met in the analysis population. Hence the data was not assessed for the outcome measure.||||||
2668302|NCT01507103|Primary|Change From Baseline in Interferon (IFN)-Gamma Secretion of Mononuclear Cells in Response to MUC1 by Enzyme-linked Immunosorbent Spot (ELISpot) at Post-baseline|IFN-gamma secretion of mononuclear cells in response to MUC1 was to be measured by ELISpot. The maximal post-baseline value out of Week 5, Week 11-13 (pre-surgery), and Week 16-18 (follow-up / end-of trial) was evaluated in comparison to Baseline.|Baseline, Week 5, Week 13 (pre-surgery), and Week 18 (end-of trial)|Data were not analyzed as no acceptable ELISpot assay is available||||||
2668303|NCT01507103|Primary|Immunological Response to Treatment in Relation to Microsatellite Instability (MSI) Status: Number of Subjects Per MSI Category|A potential association between MSI status (present or absent) and the primary endpoints (difference from baseline to surgery in CD8+ and CD8+/GrB+ T cell infiltration) was evaluated. Determination of mismatch repair protein (MRP)-expression (hMLH1, hMSH2, hMSH6 and hPMS2) was performed for the detection of the MSI-H-phenotype by IHC and/or on tumor deoxyribonucleic acid (DNA) sample using 5 microsatellite markers (BAT-25, BAT-26, NR-21, NR-24 and MONO-27).|18 weeks|Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive.|||subjects|||Number
2668304|NCT01507103|Primary|Change From Baseline in Tumor Immune Response Evaluated by Immunohistochemical (IHC) Analysis of Tumor Infiltrating Lymphocytes (TILs) at Week 14 (Post-surgery)|Tumor biopsy samples were collected prior to baseline and after the surgery. The TILs were evaluated in 3 of the most abundant high-power fields (x40) per sample and the mean value considered (after excluding the lowest and the highest value). The tumor immune response was calculated as number of TILs divided by 100 tumor cells.|Baseline and Week 14 (post-surgery)|Immunomonitoring analysis set included all subjects for whom at least the baseline ELISpot blood and tumor sample, tumor sample at surgery and pre-surgery ELISpot blood drawing are available and whose tumor biopsy at baseline is MUC1-positive. Within the data table, n=number of subjects analyzed for each category.|||TILs per 100 tumor cells||Standard Deviation|Mean
2668305|NCT01507090|Secondary|Predictive Performance of the Mercy Method|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|Final population for data analysis.|||root mean square error (kg)|||Number
2668306|NCT01507090|Secondary|Predictive Performance of the Mercy Method|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|Final population for data analysis.|||correlation coefficieint|||Number
2668307|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Mean Percentage Error)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|Final population for data analysis.|||percentage error||Standard Deviation|Mean
2668308|NCT01507090|Primary|Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (% Within 10%)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the percentage weight estimations using the Mercy TAPEs that are within 10% of the weight estimations using the Mercy Method.|study day 1|Final population for data analysis.|||percent of estimations||95% Confidence Interval|Number
2668309|NCT01507090|Primary|Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Concordance Corelation Coefficient)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the intercept of the regression equation comparing method predicted vs. TAPE predicted weight.|study day 1|Final population for data analysis.|||unitless||95% Confidence Interval|Number
2668310|NCT01507090|Primary|Equivalence of the Mercy Method and the 2D and 3D Mercy TAPEs (Ratio)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with weight generated by the Mercy method (kg). Outcome measures reported below reflect the slope of the regression equation comparing method predicted vs. TAPE predicted weight.|study day 1|Final population for data analysis.|||unitless||95% Confidence Interval|Number
2668311|NCT01507090|Primary|Predictive Performance of the Mercy TAPE|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)|study day 1|Final population for data analysis|||root mean square error (kg)|||Number
2668312|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Corelation Coefficient)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg)|study day 1|Final population for data analysis|||correlation coefficient|||Number
2668313|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Mean Error)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg)|study day 1|Final population for data analysis.|||kilograms||Standard Deviation|Mean
2668314|NCT01507090|Secondary|Predictive Performance of the Mercy Method (Percent of Participants)|Evaluate the weight generated by the Mercy method (kg) with the actual weight (kg). The outcome measure below relfects the percent of participants with weight estimated within within 20% of actual weight.|study day 1||||percent of participants||95% Confidence Interval|Number
2668323|NCT01507090|Primary|Predictive Performance of the Mercy TAPE (Percent of Participants Predicted Within 20% of Their Actual Weight)|Evaluate the weight generated by the 2D and 3D Mercy TAPE (kg) with the actual weight (kg). Outcome measures reported below reflect the percentage of participants whose weight estimations using the Mercy TAPEs are within 20% of their actual weight.|study day 1|Final population for data analysis.|||percentage of participants||95% Confidence Interval|Number
2668324|NCT01507051|Secondary|Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration, Normalized by Dose (Ctrough,ss/D) of S-warfarin After the Last Dose of Warfarin|Ctrough,ss/D refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration, normalized by dose.|0 h (predose) and 24 h after the last administration of warfarin|PK/PD set|||1/Liter||Geometric Coefficient of Variation|Geometric Mean
2668325|NCT01507051|Secondary|Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration (Ctrough,ss) of S-warfarin After the Last Dose of Warfarin|Ctrough,ss refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration.|0 h (predose) and 24 h after the last administration of warfarin|PK/PD set|||Microg/L||Geometric Coefficient of Variation|Geometric Mean
2668326|NCT01507051|Secondary|Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration, Normalized by Dose (Ctrough,ss/D) of R-warfarin After the Last Dose of Warfarin|Ctrough,ss/D refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration, normalized by dose.|0 h (predose) and 24 h after the last administration of warfarin|PK/PD set|||1/Liter||Geometric Coefficient of Variation|Geometric Mean
2668327|NCT01507051|Secondary|Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration (Ctrough,ss) of R-warfarin After the Last Dose of Warfarin|Ctrough,ss refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration.|0 h (predose) and 24 h after the last administration of warfarin|PK/PD set|||Microg/L||Geometric Coefficient of Variation|Geometric Mean
2668328|NCT01507051|Secondary|Half Life Associated With Terminal Slope (t1/2) of Rivaroxaban After Last Dose|Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination.|3, 24, 48, and 72 h after the last administration of rivaroxaban|PK/PD set; derived parameter could not be evaluated for all participants.|||hours||Geometric Coefficient of Variation|Geometric Mean
2668329|NCT01507051|Secondary|Drug Concentration in Plasma at Expected Time of Minimum (Trough) Concentration (Ctrough) of Rivaroxaban After Second to Fourth Dose|Ctrough refers to the time after dosing when the drug concentration is expected to reach its minimum (trough) concentration.|Always 24 h after the second, third, and fourth dose|PK/PD set|||Microg/L||Geometric Coefficient of Variation|Geometric Mean
2668330|NCT01507051|Secondary|Drug Concentration in Plasma at Expected Time of Maximum (Peak) Concentration (Cpeak) of Rivaroxaban After Second to Fourth Dose|Cpeak refers to the time after dosing when the drug concentration is expected to reach its maximum (peak) concentration.|Always 3 h after second, third, and fourth dose|PK/PD set|||Microg/L||Geometric Coefficient of Variation|Geometric Mean
2668331|NCT01507051|Secondary|Time to Reach Maximum Drug Concentration in Plasma (Tmax) of Rivaroxaban After First Dose|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set|||hours||Full Range|Median
2668332|NCT01507051|Secondary|Maximum Drug Concentration in Plasma Divided by Dose Per kg Body Weight (Cmax,Norm) of Rivaroxaban After First Dose|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; Cmax,norm is defined as Cmax divided by dose (mg) per kg body weight.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set|||Kg/L||Geometric Coefficient of Variation|Geometric Mean
2668333|NCT01507051|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours Divided by Dose Per kg Body Weight [AUC(0-24)Norm] of Rivaroxaban After First Dose|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; [AUC(0-24)norm] is defined as AUC divided by dose per kg body weight from zero to 24 hours after first (single) dose.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set|||Kg*h/L||Geometric Coefficient of Variation|Geometric Mean
2668334|NCT01507051|Secondary|Half Life Associated With Terminal Slope (t1/2) of S-warfarin After the Last Dose of Warfarin|Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination.|Blood samples taken at 24, 30, 48, 54, 72, 96, and 120 h after the last administration of warfarin|PK/PD set|||hours||Geometric Coefficient of Variation|Geometric Mean
2668335|NCT01507051|Secondary|Half Life Associated With Terminal Slope (t1/2) of R-warfarin After the Last Dose of Warfarin|Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination.|Blood samples taken at 24, 30, 48, 54, 72, 96, and 120 h after the last administration of warfarin|PK/PD set|||hours||Geometric Coefficient of Variation|Geometric Mean
2668336|NCT01507051|Secondary|Maximum Drug Concentration in Plasma (Cmax) of Rivaroxaban After First Dose|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set|||microg/L||Geometric Coefficient of Variation|Geometric Mean
2668337|NCT01507051|Secondary|Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours [AUC(0-24)] of Rivaroxaban After First Dose|The AUC is a measure of systemic drug exposure which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample ([AUC(0-24)] is defined as area under the concentration vs. time curve from zero to 24 hours after first (single) dose).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban|PK/PD set|||microg*h/L||Geometric Coefficient of Variation|Geometric Mean
2668338|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Factor IIa Activity|Factor II (Thrombin) is a coagulation factor that is required for the coagulation process. AUC(0-tn) of Factor IIa activity was the area under the measurement (Factor IIa activity [measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma] at baseline divided by Factor IIa activity [measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma] at different time-points) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
2668339|NCT01507051|Secondary|Emax (Maximum Effect) on Factor IIa Activity|Factor II (Thrombin) is a coagulation factor that is required for the coagulation process. Emax on Factor IIa activity was measured as the ratio of Factor IIa activity (measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma) at baseline divided by minimum Factor IIa activity (measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio||Geometric Coefficient of Variation|Geometric Mean
2668340|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Factor VIIa Activity|Factor VII is a coagulation factor that is required for the coagulation process. AUC(0-tn) of Factor VIIa activity was the area under the measurement (Factor VIIa activity [measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma] at baseline divided by Factor VIIa activity [measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma] at different time-points) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
2668341|NCT01507051|Secondary|Emax (Maximum Effect) on Factor VIIa Activity|Factor VII is a coagulation factor that is required for the coagulation process. Emax on Factor VIIa activity was measured as the ratio of Factor VIIa activity (measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma) at baseline divided by minimum Factor VIIa activity (measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio||Geometric Coefficient of Variation|Geometric Mean
2668342|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) Peak Time|ETP peak time assesses the overall function of the clotting cascade. The peak time assesses the time required to reach the maximal thrombin generation. Increasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP peak time was the area under the measurement (ETP peak time [measured in minutes as time to reach the maximum coagulation activity] at different time-points divided by ETP peak time [measured in minutes as time to reach the maximum coagulation activity] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
2668343|NCT01507051|Secondary|Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) Peak Time|ETP peak time assesses the overall function of the clotting cascade. The peak time assesses the time required to reach the maximal thrombin generation. Increasing values compared to baseline indicate an anticoagulant effect. Emax on ETP peak time was measured as the ratio of maximum ETP peak time (measured in minutes as time to reach the maximum coagulation activity) divided by ETP peak time (measured in minutes as time to reach the maximum coagulation activity) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio||Geometric Coefficient of Variation|Geometric Mean
2668344|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) Peak|ETP peak assesses the overall function of the clotting cascade. The peak assesses the overall maximal ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP peak was the area under the measurement (ETP peak [measured in nm as maximum coagulation activity] at baseline divided by ETP peak measured [in nm as maximum coagulation activity] at different time-points) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
2668345|NCT01507051|Secondary|Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) Peak|ETP peak assesses the overall function of the clotting cascade. The peak assesses the overall maximal ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. Emax on ETP peak was measured as the ratio of ETP peak (measured in nm as maximum coagulation activity) at baseline divided by minimum ETP peak (measured in nm as maximum coagulation activity).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio||Geometric Coefficient of Variation|Geometric Mean
2668346|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) Lag Time|ETP lag time assesses the overall function of the clotting cascade. The lag time assesses the time required until thrombin is generated. Increasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP lag time was the area under the measurement (ETP lag time [in minutes as measure for the start of coagulation] at different time-points divided by ETP lag time [in minutes as measure for the start of coagulation] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
2668347|NCT01507051|Secondary|Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) Lag Time|ETP lag time assesses the overall function of the clotting cascade. The lag time assesses the time required until thrombin is generated. Increasing values compared to baseline indicate an anticoagulant effect. Emax on ETP lag time was measured as the ratio of maximum ETP lag time (in minutes as measure for the start of coagulation) divided by ETP lag time (in minutes as measure for the start of coagulation) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio||Geometric Coefficient of Variation|Geometric Mean
2668348|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) AUC|ETP AUC assesses the overall function of the clotting cascade. The AUC assesses the overall ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP AUC was the area under the measurement (ETP AUC [measured in nm*min as integral of fluorescence measurements] at baseline divided by ETP AUC [measured in nm*min as integral of fluorescence measurements] at different time-points) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
2668349|NCT01507051|Secondary|Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) AUC|ETP AUC assesses the overall function of the clotting cascade. The AUC assesses the overall ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. Emax on ETP AUC was measured as the ratio of ETP AUC (measured in nm*min as integral of fluorescence measurements) at baseline divided by minimum ETP AUC (measured in nm*min as integral of fluorescence measurements).|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio||Geometric Coefficient of Variation|Geometric Mean
2668350|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of PiCT (Prothrombinase-induced Clotting Time)|This coagulation test can be adapted to measure different anticoagulants, including inhibitors of Factor X. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of PiCT was the area under the measurement (PiCT [measured in seconds] at different time-points divided by PiCT [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
2668351|NCT01507051|Secondary|Emax (Maximum Effect) on PiCT (Prothrombinase-induced Clotting Time)|This coagulation test can be adapted to measure different anticoagulants, including inhibitors of Factor X. Higher values than the baseline indicate anticoagulant effects. Emax on PiCT was measured as the ratio of maximum PiCT (measured in seconds) divided by PiCT (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2668352|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of HepTest (Coagulation Test)|This coagulation test was developed to monitor heparin and especially low-molecular weight heparins (LMWH). It is sensitive to measure Factor X. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of HepTest was the area under the measurement (HepTest [measured in seconds] at different time-points divided by HepTest [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
2668353|NCT01507051|Secondary|Emax (Maximum Effect) on HepTest (Coagulation Test)|This coagulation test was developed to monitor heparin and especially low-molecular weight heparins (LMWH). It is sensitive to measure Factor X. Higher values than the baseline indicate anticoagulant effects. Emax on HepTest was measured as the ratio of maximum HepTest (measured in seconds) divided by HepTest (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2668354|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of aPTT (Activated Partial Thromboplastin Time)|The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of aPTT was the area under the measurement (aPTT [measured in seconds] at different time-points divided by aPTT [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
2668355|NCT01507051|Secondary|Emax (Maximum Effect) on aPTT (Activated Partial Thromboplastin Time)|The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects. Emax on aPTT was measured as the ratio of maximum aPTT (measured in seconds) divided by aPTT (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio||Geometric Coefficient of Variation|Geometric Mean
2668356|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Anti-Factor Xa Activity|This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. Higher Values than the baseline indicate a more pronounced inhibition. AUC(0-tn) of anti-Factor Xa activity was the area under the measurement (anti-Factor Xa activity [measured in U/L] at different time-points divided by anti-Factor Xa activity [measured in U/L] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
2668357|NCT01507051|Secondary|Emax (Maximum Effect) on Anti-Factor Xa Activity|This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. Higher Values than the baseline indicate a more pronounced inhibition. Emax on anti-Factor Xa activity was measured as the ratio of maximum anti-Factor Xa activity (measured in U/L) divided by anti-Factor Xa activity (measured in U/L) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set; derived parameter could not be evaluated for all participants.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2668594|NCT01504958|Secondary|Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)|23 item scale to assess activities of daily living. Scores range from 0 to 78 with a higher score indicating less functional impairment. The scores reported below are the means of the actual scores from the assessments representing the percent change from baseline.|Pre-treatment, 1 month Post-treatment||||percent change||Standard Deviation|Mean
2668358|NCT01507051|Secondary|AUC(0-tn) (Area Under the Inverse Measurement Versus Time Curve From Time 0 to the Last Data Point) of Factor Xa Activity|Test to measure the activity of endogenous Factor Xa. AUC(0-tn) of Factor Xa activity was the area under the inverse measurement [100*(Factor Xa activity at baseline (measured as activity per mL) - Factor Xa activity (measured as activity per mL) at different time-points) / Factor Xa activity at baseline (measured as activity per mL)] versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||Percentage of inhibition*h||Geometric Coefficient of Variation|Geometric Mean
2668359|NCT01507051|Secondary|Emax on Factor Xa Activity|Test to measure the activity of endogenous Factor Xa. Emax on Factor Xa activity was calculated as 100*(Factor Xa activity at baseline [measured as activity per mL] - minimum of Factor Xa activity [measured as activity per mL]) / Factor Xa activity at baseline [measured as activity per mL].|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||Percentage of inhibition||Geometric Coefficient of Variation|Geometric Mean
2668360|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) for PT (Measured as INR=International Normalized Ratio)|Prothrombin time - INR measured in seconds that is calculated as INR which is a correction for PT assay differences and an optimization to measure vitamin K antagonists. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of PT (INR) was the area under the measurement (PT measured as INR at different time-points divided by PT measured as INR at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
2668361|NCT01507051|Secondary|Emax on PT (Measured as INR=International Normalized Ratio)|Prothrombin time - INR measured in seconds that is calculated as INR which is a correction for PT assay differences and an optimization to measure vitamin K antagonists. Higher values than the baseline indicate anticoagulant effects. Emax on PT (INR) was measured as the ratio of maximum INR divided by baseline INR.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio||Geometric Coefficient of Variation|Geometric Mean
2668362|NCT01507051|Secondary|AUCBA(0-tn) (Baseline Adjusted Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Prothrombin Time (Coagulation Test)|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. AUCBA(0-tn) of PT was the area under the measurement (PT [measured in seconds] at different time-points minus PT [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||s*h||Geometric Coefficient of Variation|Geometric Mean
2668363|NCT01507051|Secondary|AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Prothrombin Time (Coagulation Test)|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of PT was the area under the measurement (PT [measured in seconds] at different time-points divided by PT [measured in seconds] at baseline) versus time curve from time 0 to the last data point.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio*h||Geometric Coefficient of Variation|Geometric Mean
2668364|NCT01507051|Primary|Emax,BA (Baseline Adjusted Maximum Effect) on Prothrombin Time (Coagulation Test)|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. Emax,BA on PT was measured as maximum PT (measured in seconds) minus PT (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||seconds||Geometric Coefficient of Variation|Geometric Mean
2668365|NCT01507051|Primary|Emax (Maximum Effect) on Prothrombin Time (PT) (Coagulation Test)|Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. Emax on PT was measured as the ratio of maximum PT (measured in seconds) divided by PT (measured in seconds) at baseline.|0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo|PK/PD set|||ratio||Geometric Coefficient of Variation|Geometric Mean
2668366|NCT01506960|Secondary|Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT).|Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization. Plaques were divided depending on depth of lipid by OCT (cut off value 130 um).|Measured at the time of cardiac catheterization|Per protocol|||mm (LCP length)|Participants|Standard Deviation|Mean
2668367|NCT01506960|Primary|Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS)|Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization.|Measured one point in time during cardiac catheterization||||% pts with lipid on NIRS and OCT|||Number
2668382|NCT01506908|Secondary|Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-cue Baseline, 3 minutes post treatment administration|ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2668368|NCT01506947|Secondary|Number of Participants With Adverse Events|"Serious adverse events were any adverse events meeting any of the following criteria:~An event that resulted in the death of a participant;~An event that, in the opinion of the investigator, would have resulted in immediate fatality if medical intervention had not been taken (life-threatening);~Resulted in an admission to the hospital for any length of time or prolonged hospital stay;~An anomaly detected at or after birth, or any anomaly that results in fetal loss;~An event that resulted in a condition that substantially interfered with the activities of daily living;~An important medical event that may not be immediately life-threatening or result in death or hospitalization, but based on medical judgment may have jeopardized the participant and may have required medical or surgical intervention to prevent any of the outcomes listed above.~Adverse events were assessed by the investigator for possible relationship to study drug."|From the time of study drug administration until 4 weeks after the discontinuation of the study drug; up to 7 months.|The safety population included all participants who enrolled.|||participants|||Number
2668369|NCT01506947|Secondary|Mean Fibroblast Growth Factor-23 (FGF-23) Level at Baseline and Month 6||Baseline and Month 6|Per-protocol analysis set with available data at each time point.|||kRU/L||Standard Deviation|Mean
2668370|NCT01506947|Secondary|Mean High Sensitivity C-reactive Protein (hsCRP) Level at Baseline and Month 6||Baseline and Month 6|Per-protocol analysis set with available data at each time point.|||mg/mL||Standard Deviation|Mean
2668371|NCT01506947|Secondary|Folic Acid Levels|"Folic acid levels were categorized according to the following laboratory reference ranges:~Low: < 4.6 ng/mL Normal: 4.6 - 18.7 ng/mL High: > 18.7 ng/mL"|Baseline and month 6|Per-protocol analysis set with available data at each time point.|||Participants|||Count of Participants
2668372|NCT01506947|Secondary|Vitamin B12 Levels|"Vitamin B12 levels were categorized according to the following laboratory reference ranges:~Low: < 200 pg/mL Normal: 200 - 950 pg/mL High: > 950 pg/mL"|Baseline and month 6|Per-protocol analysis set with available data at each time point.|||Participants|||Count of Participants
2668373|NCT01506947|Secondary|Mean Alkaline Phosphatase Level at Baseline and Month 6||Baseline and Month 6|Per-protocol analysis set with available data at each time point.|||U/L||Standard Deviation|Mean
2668374|NCT01506947|Secondary|Mean Phosphorus Level at Baseline and Month 6||Baseline and Month 6|Participants who completed the study with available data at each time point.|||mg/mL||Standard Deviation|Mean
2668375|NCT01506947|Secondary|Mean Calcium Level at Baseline and Month 6||Baseline and Month 6|Per-protocol analysis set with available data at each time point.|||mg/mL||Standard Deviation|Mean
2668376|NCT01506947|Secondary|Mean Intact Parathyroid Hormone (iPTH) Level at Baseline and Month 6||Baseline and Month 6|Per-protocol analysis set with available data at each time point.|||pg/mL||Standard Deviation|Mean
2668377|NCT01506947|Secondary|Mean Scores of Short Form Health Survey 36 (SF-36) Questionnaire|The Medical Outcome Study Short Form 36-Item Health Survey (SF-36) is a self-administered questionnaire that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains. The domains include physical (physical functioning, role limitations due to physical health (role-physical), general health perceptions and pain) and mental domains (energy/fatigue (vitality), social functioning, emotional well-being (mental health), and role limitations due to emotional problems (role emotional)). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning.|Baseline and Month 6|Per-protocol analysis set|||units on a scale||Standard Deviation|Mean
2668378|NCT01506947|Primary|Mean Erythropoietin Dose Per Visit|The requirement of erythropoietin (EPO) treatment to maintain serum hemoglobin levels between 10 to 11.5 g/dL during the study was assessed by analysis of the dose of darbepoetin alfa used at baseline and during each month of the study. The mean EPO dosage per injection for each study month is reported.|Baseline and Months 1, 2, 3, 4, 5 and 6|Per-protocol analysis set with EPO dosage available at all visits.|||µg||Standard Deviation|Mean
2668379|NCT01506908|Secondary|Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs)|AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s. Treatment related AE was defined as any AE considered to be possibly, probably or highly probably related to study medication. SAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect.|Baseline to Day 5 post treatment administration|Safety population: All randomized participants who received the study treatments were considered evaluable for safety.|||Participants|||Number
2668380|NCT01506908|Secondary|Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-Cue Baseline, 10 minutes post treatment administration|ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique|||Score on a scale||95% Confidence Interval|Least Squares Mean
2668381|NCT01506908|Secondary|Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-Cue Baseline, 7 minutes post treatment administration|ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2668410|NCT01506726|Primary|Change in Hemoglobin Level From Baseline to 6 Month Visit|To test whether the administration of oral salsalate to a subset of elderly subjects with unexplained anemia (UAE) and high interleukin (IL-6) levels will improve hemoglobin level|baseline; 6 months||||g/dL||Standard Deviation|Mean
2668383|NCT01506908|Secondary|Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-cue baseline, 1 minute post treatment administration|ITT population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on LOCF technique.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2668384|NCT01506908|Primary|Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Post-cue baseline,5 minutes|Intention to Treat (ITT) population: All randomized participants who had at least one cravings assessment measurement post dose. The imputation of missing craving score was based on last observation carried forward (LOCF) technique.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2668385|NCT01506882|Secondary|Time to Withdrawal in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group|Median time to withdrawal will be estimated from the Kaplan-Meier curve.|During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.|||days||95% Confidence Interval|Median
2668386|NCT01506882|Secondary|Time to First Seizure in Subjects in the Levetiracetam (LEV) 3000 mg/Day Group|"Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.~The Median time to first seizure will be estimated from the Kaplan-Meier curve."|During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.|||days||95% Confidence Interval|Median
2668387|NCT01506882|Secondary|Time to Withdrawal at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group|Median time to withdrawal will be estimated from the Kaplan-Meier curve.|During 1-week Stabilization Period, Evaluation, Maintenance and Safety Follow Up Period, assessed up to 1 year|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.|||days||95% Confidence Interval|Median
2668388|NCT01506882|Secondary|Time to First Seizure at the Last Evaluated Dose in Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group|"Time was measured from first day of last evaluated dose. Seizures during Stabilization were not considered.~The Median time to first seizure will be estimated from the Kaplan-Meier curve."|During Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period, assessed up to 1 year|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.|||days||95% Confidence Interval|Median
2668389|NCT01506882|Secondary|Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period|Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving LEV 3000 mg/day during the 26-weeks Maintenance Period unless a seizure occurs.|From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.|||percentage of participants||95% Confidence Interval|Number
2668390|NCT01506882|Secondary|Percentage of Subjects in the Levetiracetam (LEV) 3000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period|"A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:~A documented seizure during 6 consecutive months of the Evaluation Analysis Period~Subject discontinued the study prematurely during the Evaluation Analysis Period~Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period."|From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period.|||percentage of participants||95% Confidence Interval|Number
2668391|NCT01506882|Secondary|Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 52 Consecutive Weeks of Treatment During the Evaluation Period and the Maintenance Period|Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving the same dose of LEV as in the Evaluation Period during the 26-weeks Maintenance Period unless a seizure occurs.|From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period|Data for this secondary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.|||percentage of participants||95% Confidence Interval|Number
2668411|NCT01506596|Secondary|Overall Survival (OS)|OS was measured from date of consent until time of death from any cause, up to 32 months.|Date of Consent until death, up to 32 months||||months||95% Confidence Interval|Median
2669103|NCT01498991|Secondary|Modified Ashworth Scale||Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).|The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.||||||
2668392|NCT01506882|Primary|Percentage of Subjects in the Levetiracetam (LEV) 1000 mg/Day to 2000 mg/Day Group Who Are Seizure Free for 26 Consecutive Weeks of Treatment During the Evaluation Period|"A subject was considered seizure free, if no seizure occurred during the 6 consecutive months (26 weeks) in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:~A documented seizure during 6 consecutive months of the Evaluation Analysis Period~Subject discontinued the study prematurely during the Evaluation Analysis Period~Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period."|From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period|Data for the primary outcome measure refer to the Full Analysis Set (FAS). FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.|||percentage of participants||95% Confidence Interval|Number
2668393|NCT01506726|Secondary|Assessment of Serum Biomarkers of Erthropoiesis|To assess whether oral salsalate improves serum biomarkers of erythropoiesis by decreasing growth differentiation factor-15 (GDF-15) in UAE subjects. Change in the GDF-15 from prior to study drug to 6 months.|prior to study drug; 6 months|One subject in the active drug oral salsalate arm and two subjects in the placebo arm are missing outcome measures.|||pg/ml||Standard Deviation|Mean
2668394|NCT01506726|Secondary|Change in Markers of Inflammation|To assess whether oral salsalate reduces C-reactive protein (CRP) in UAE subjects. Change in the CRP from prior to study drug to 6 months.|prior to study drug; 6 months|One subject in the active drug oral salsalate group and two subjects in the placebo arm group were missing outcome measures.|||ug/ml||Standard Deviation|Mean
2668395|NCT01506726|Secondary|Change in Frailty Component as Determined by the 4 Meter Walk Speed|"To quantify the impact of anemia treatment by salsalate on change in the speed of the 4 meter walk speed. Subjects are asked to walk as fast as they can for 4 meters. Frailty was determined by the subject's speed. (change from frail at baseline to not frail at 6 months). 4 m walking speed is stratified by gender and height. For men, (height of <= 173 cm and a walking speed of <= 0.65 meter/sec) or a (height > 173, <= .76 meter/sec) were classified as frail. For women, (height of <= 159 cm and a walking speed of <=.65 meter/sec) or (height >159 cm <= 0.76 meter/sec) were classified as frail.The outcome is the number of participants who were classified as frail at baseline and changed to not frail at 6 months."|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.|||participants|||Number
2668396|NCT01506726|Secondary|Change in Frailty Component as Determined by Grip Strength|"To quantify the impact of anemia treatment by salsalate on change in the frailty as measured by change in grip strength. Subjects squeeze the grip strength machine 3 times with each hand. For the frailty outcome the maximum grip strength from the dominant hand is used. (change from frail at baseline to not frail at 6 months). Grip strength is stratified by gender and BMI. For men with (BMI <= 24 and a grip strength (GS) <= 29) or (BMI 24.1-28 and grip strength <= 30) or (BMI >28 and a grip strength <= 32) were classified as frail. For women with (BMI <= 23 and a grip strength of <= 17) or (BMI 23.1-26 and a GS <= 17.3) or (BMI 26.1-29 and a GS <= 18) or (BMI > 29 and a GS <= 21) were classified as frail.The outcome is the number of participants who were classified as frail at baseline and changed to not frail at 6 months."|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.|||participants|||Number
2668397|NCT01506726|Secondary|Change in the Frailty Component as Determined by Self-reported Activity Level|"To quantify the impact of anemia treatment by salsalate on change in the frailty as measured by change in self-reported activity level. Frailty for activity level is classified by subjects responses to 6physical activity questions on the short version of the Minnesota Leisure Time Activity Questionnaire , were related to walking for exercise, moderately strenuous outdoor chores, dancing, bowling, and regular exercise. The Women's Health And Aging Study (WHAS) scoring algorithm was used to define frailty for self-reported activity level. The answers to these questions were used to calculate kilocalories (Kcals) per week, using the WHAS algorithm, which is further satisfied by by gender. For men, Kcals < 128 per week is frail. For women, Kcals < 90 per week is frail. This is a categorical measurement of yes or no. The outcome is the number of participants who were classified as frail at baseline and changed to not frail at 6 months."|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.|||participants|||Number
2668398|NCT01506726|Secondary|Change in Self Reported Outcomes Measures as Reported by FACIT-AN Total Score|To quantify the impact of anemia treatment by salsalate on self -reported outcomes measures by subjects answering 47 questions for patients with anemia and or fatigue. This test detects self-report functional changes and QoL. Change from baseline to 6 months. Scores range from 0-188 with higher scores indicating better function.|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.|||scores on a scale||Standard Deviation|Mean
2668399|NCT01506726|Secondary|Change in Self Reported Outcomes Measures as Reported by Short Form-36 (SF-36) Physical Component Score (PCS)|To quantify the impact of anemia treatment by salsalate on self-reported outcomes measures by change in SF36 physical component score. The SF-36 form identifies self-report physical function and global measure of quality of life and is a multi-purpose, short-form health survey consisting of 36 questions. The Physical Component Summary (PCS) is a subscale of the SF-36 that correlates with physical health domains of the SF-36 ( Physical Function, Role-Physical, and Bodily Pain). The change is calculated and compared from baseline to 6 months. The SF-36 PCS score is a norm based sore with a mean of 50 and standard deviation of 10 where results above and below 50 are above and below the average, respectively, in the 2009 general US population.|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.|||t score||Standard Deviation|Mean
2668412|NCT01506596|Secondary|Duration of Response|Response is defined as Complete Response (CR) or Partial Response (PR) per RECIST v1.1. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Confirmation of CR or PR is required by repeat scans that should be performed 4 weeks after the criteria for response are first met.|Measure of the amount of time that the criteria for response per RECIST are first met until disease progression|Since so few patients experienced a response, the pre-specified endpoint of duration of response was not analyzed.||||||
2668400|NCT01506726|Secondary|Change in Cognitive Outcome Measures as Determined by Composite Learning and Memory|To quantify the impact of anemia treatment by salsalate on cognitive outcomes based on Learning and memory was derived using the z-scores of the following three tests: (1) CogState ISL immediate recall score (total score from three learning trials), (2) CogState ISL immediate recall score from the first learning trial, and (3) CogState ISL delayed recall scores. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average. The change in the Z-score from baseline to month 6.|baseline; 6 months|One subject in the active drug oral salsalate group and 3 in the placebo arm group were missing outcome measure.|||change in Z-Score||Standard Deviation|Mean
2668401|NCT01506726|Secondary|Change in Cognitive Outcome Measures as Determined by Composite Complex Attention/Executive Processing|To quantify the impact of anemia treatment by salsalate on cognitive outcomes based on Complex attention/executive processing was derived using the z-scores of the following three tests: (1) TMT Part B seconds per completed circle, (2) time score from the CogState One Back Task, and (3) accuracy score from the CogState One Back Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the overall baseline mean of the test from the subject's score at the time point (accuracy score) or by subtracting the subject's score at the time point from the overall baseline mean of the test (TMT and time score) and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average. The change in the Z-score from baseline to month 6.|baseline; 6 months|One subject in the active drug oral salsalate group and 3 in the placebo arm group were missing outcome measure.|||change in Z-Score||Standard Deviation|Mean
2668402|NCT01506726|Secondary|Change in Cognitive Outcome Measures as Determined by Speed of Processing|To quantify the impact of anemia treatment by salsalate on cognitive outcomes based on speed of processing was derived using the z-scores of the following three tests: (1) TMT Part A seconds per completed circle, (2) simple reaction time from the CogState Detection Task, and (3) choice reaction time from the CogState Identification Task. The composite score for a subject at each time point was defined as the mean of the Z-scores for the three tests at the time point. For each subject, the Z-score for each test at time point was derived by subtracting the subject's score at the time point from the overall baseline mean of the test and then dividing by the overall baseline standard deviation of the test. Positive z-scores indicate a better performance compared to the baseline average.The change in the Z-score from baseline to month 6.|baseline; 6 months|One subject in the active drug oral salsalate group and 3 in the placebo arm group were missing outcome measure.|||change in Z-Score||Standard Deviation|Mean
2668403|NCT01506726|Secondary|Change in Frailty Component Related to Fatigue/ Exhaustion|"Subjective fatigue/exhaustion: If any of the following three criteria are met, the patient will be classified as frail for fatigue/exhaustion:~In the past month, on average, have you been feeling unusually tired during the day? is answered yes and indicated as all of the time or most of the time.~In the past month, on average, have you felt unusually weak? is answered yes and indicated as all of the time or most of the time.~Energy level on a scale of 0 (no energy) to 10 (most energy) reported as ≤ 3. If the subject answers YES to any of the above noted 3 questions, then they are classified as FRAIL.~The change in frailty for fatigue/ exhaustion is defined as changing from frail at baseline to not frail at month 6 as reported by the subject."|baseline; 6 months|One subject in the active drug oral salsalate group and 2 in the placebo arm group were missing outcome measure.|||participants|||Number
2668404|NCT01506726|Secondary|Change in Cognitive Outcome Measures-Trail Making Test Part B|To quantify the impact of anemia treatment by salsalate on cognitive outcomes based on the Trail Making Test (TMT) Part B as measured by subjects drawing a line from 25 circled numbers to letters in 300 seconds. The change in seconds per completed circle from baseline to month 6.|baseline; 6 months|Two subjects in the active drug oral salsalate group and 3 in the placebo arm group were missing outcome measure.|||second per completed circle||Standard Deviation|Mean
2668405|NCT01506726|Secondary|Change in Serum Hepcidin Levels|To compare the change in serum hepcidin levels between treatment groups and whether such a change is proportional to the decline in IL-6 levels. Change in the hepcidin from prior to study drug to 6 months. Positive changes represent increases in hepcidin levels and negative changes represent decreases.|prior to study drug; 6 months|One subject in the active drug oral salsalate arm and 3 subjects in the placebo arm are missing outcome measures.|||ng/ml||Standard Deviation|Mean
2668406|NCT01506726|Secondary|Assessment of Serum Biomarkers of Erthropoiesis|To assess whether oral salsalate improves serum biomarkers of erythropoiesis by increasing erythropoietin (Epo) in UAE subjects. Change in the Epo from prior to study drug to 6 months.|prior to study drug; 6 months|One subject in the active drug oral salsalate arm and two subjects in the placebo arm are missing outcome measures.|||mIU/ml||Standard Deviation|Mean
2668407|NCT01506726|Secondary|Change in Markers of Inflammation|To assess whether oral salsalate reduces markers of inflammation including IL-6 and Tumor Necrosis Factor Receptor1 (TNF-R1) in UAE subjects. Change in the marker from prior to study drug to 6 months.|prior to study drug; 6 months|One subject in the active drug oral salsalate group and two subjects in the placebo arm group were missing outcome measures.|||pg/ml||Standard Deviation|Mean
2668408|NCT01506726|Other Pre-specified|Association Between Change in Hemoglobin and Change in Markers of Inflammation.|To examine whether there is an association between change in hemoglobin and changes in markers of inflammation from prior to study drug to 6 months. Inflammatory markers to be measured are iL-6, Tumor Necrosis Factor alpha Receptor1 (TNF-R1), and C-reactive protein (CRP) in anemia subjects.Correlation between change in the inflammatory markers and the change in HB from prior to study drug to 6 months.|prior to study drug; 6 months|One subject from the active drug oral salsalate group and 2 subjects from the placebo arm group are missing outcomes.|||correlation coefficient|||Number
2668409|NCT01506726|Other Pre-specified|Change in the 6 Minute Walk Test (6MWT) Distance.|To assess the impact of treatment of anemia with oral salsalate will improve 6 minute walk test (6MWT) distance from baseline to 6 months as measured in meters and centimeters.|baseline; 6 months|Two subjects were missing outcome measure in both the active drug and the placebo arm.|||meters||Standard Deviation|Mean
2668413|NCT01506596|Secondary|Best Overall Response|Best overall response is defined as the best response across all time points. Repeat radiologic imaging was conducted after every 3 cycles of treatment (approximately every 12 weeks). Response was evaluated using RECIST v1.1 guidelines, where complete response (CR) is the disappearance of all target and non-target lesions; partial response (PR) is >=30% decrease in the sum of diameters of target lesions; progressive disease (PD) is >=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of >=1 new lesion; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Date of consent until end of study treatment, up to 32 months||||percentage of participants|||Number
2668414|NCT01506596|Secondary|Progression Free Survival (PFS)|PFS was measured from date of consent until the subject experiences disease progression (assessed approximately every 12 weeks) or death, whichever came first, up to 27 months. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Subjects who discontinue study treatment for reasons other than disease progression will continue to have their disease status reported every 3 months post end of treatment up to 27 months.|Date of Consent until progression or death, up to 27 months||||months||95% Confidence Interval|Median
2668415|NCT01506596|Primary|12-week Progression Free Rate|Progression will be as defined per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 1.1. Subjects who remain under observation and progression free at 12 weeks will be defined as treatment successes. Subjects who progress per RECIST by 12 weeks or who drop out without evidence of progression prior to 12 weeks will be defined as treatment failures.Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as a >=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of >=1 new lesion.|Assessed after 12 weeks of study treatment||||percentage of participants||95% Confidence Interval|Number
2668416|NCT01506479|Other Pre-specified|Number of Days of Exercise Per Week|The number of days the participant exercised per week|9 to 26 weeks|Participants were analyzed in the group to which they were assigned. Participants were not included if they did not start the intervention.|||Number of days per week||95% Confidence Interval|Mean
2668417|NCT01506479|Secondary|6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score|Participants were assessed at baseline and at 6 months on their UPDRS. If a participant initiated Parkinson disease medication prior to the 6 month assessment, the UPDRS score from the clinical visit assessment prior to this initiation was used as the score for the individual at 6 months. The change in the UPDRS motor score at 6 months was used as the measure for the futility component of the trial. The change at 6 months was measured as the 6 month value minus the baseline score. A positive change represents worsening of motor symptoms; 0 represents no change; negative values represent improvement. The minimum score on the UPDRS motor is 0 and the maximum is 108 at baseline and 6 months with higher scores representing worse motor symptoms.|Baseline and 6 months|Intention to treat; participants were analyzed in the group to which they were assigned. If a participant started medication, the UPDRS measure prior to initiating medication was used even if the 6 month data were not collected. Participants who did not start medications and were missing the 6 month assessment were not included.|||units on the UPDRS Motor scale||95% Confidence Interval|Mean
2668418|NCT01506479|Primary|Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise|To test whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% average HRmax or 80-85% average HRmax) and adhere to the exercise protocol.|9 to 26 weeks|Only for participants who contributed heart rate monitor data.|||percentage of maximum heart rate||95% Confidence Interval|Mean
2668419|NCT01506453|Secondary|Pain Score During the Previous 24 Hours|A score ranging from 0 to 10, measured by age appropriate validated pain scale. Because there was only one patient during day 21 time point for this treatment group, the mean and standard deviation could not be calculated.Infants and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Scale-Revised (FPS-R) Ages >7 years, Self report using a numeric scale 0-10 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain.The scale information for the FLACC and FPS-R scales are similar.|Daily beginning day 1 through a maximum of 21 days|There were participants in the Gabapentin and Placebo groups that did not have pain assessments at various time points. Pain score was 0 for each placebo participant on days 20 and 21.|||score on a scale 0-10||Standard Deviation|Mean
2668420|NCT01506453|Secondary|Pain Scores Right Now|A score ranging from 0 to 10, measured by age appropriate validated pain scale. Because there was only one patient during day 21 time point for this treatment group, the mean and standard deviation could not be calculated. Infants and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Scale-Revised (FPS-R) Ages >7 years, Self report using a numeric scale 0-10 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain.The scale information for the FLACC and FPS-R scales are similar.|Daily beginning day 1 through a maximum of 21 days.|There were participants in the Gabapentin and Placebo groups that did not have pain assessments at various time points. Pain score was 0 for each placebo participant on days 19, 20 and 21.|||score on a scale 0-10||Standard Deviation|Mean
2668429|NCT01506323|Secondary|Patient Health Questionnaire (PHQ-9) for Depression|PHQ-9 is a 9-item depression screening tool based on the diagnostic criteria for major depressive disorder in the DSM-IV. Each item is rated from a 0 (not at all) to 3 (nearly every day) scale. Items are summed and total scores range from 0 to 27. Higher scores indicate worse depression. A score of 11 or more considered probable depression and 20 or more is considered severe depression. It is well-validated and widely-used in medical settings such as primary care. The PHQ-9 includes the two major symptom domains characteristic of depression: affective and somatic symptoms.|Baseline to post-treatment (week 8); Baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
2668421|NCT01506453|Primary|Daily Total Dose of Oral Morphine (mg/kg/Day).|The response to therapy will be measured by pain intensity scores and daily use of morphine doses for breakthrough pain as described in the study objectives. Daily assessments will continue during treatment with the study drug (gabapentin or placebo) irrespective of patient response to study treatment. and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Scale-Revised (FPS-R) Ages >7 years, Self report using a numeric scale 0-10 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain. The scale information for the FLACC and FPS-R scales are similar.|Daily beginning day 1 for a maximum of 21 days.|The daily morphine dosage will be modeled as longitudinal observations with treatment (gabapentin vs. placebo) group, and if necessary, other clinical factors such as age category for pain assessment (0-3yr, 4-7yr, >7yr), baseline pain score, and ALL risk classification, as explanatory factors, using repeated measure linear models|||mg/kg/day||Standard Deviation|Mean
2668422|NCT01506362|Secondary|Proportion of Patients With Mucosal Healing After Completion of Study Treatment Defined as Reduction in Endoscopy Subscore of ≥ 1 From Baseline & an Absolute Endoscopy Subscore of ≤ 1 Assessed by Flexible Sigmoidoscopy.||5 weeks following first administration|||||||
2668423|NCT01506362|Primary|Proportion of Patients Who After Study Completion Achieve Clinical Response Defined by at Least a 3point Decrease & 30% Reduction From Baseline in Mayo Score Plus ≥ 1 Point Decrease in Rectal Bleeding Sub-score or Absolute Rectal Bleeding Subscore of ≤ 1|"Mayo score assesses stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment. It is assessed according to the following parameters:~Stool frequency (subscore 0-3) 0: Normal number of stools for patient~1 to 2 stools per day more than normal~3 to 4 stools more than normal~> or = to 5 stools more than normal~Rectal bleeding (subscore 0-3) 0: No blood seen~Streaks of blood with stool less than half the time~Obvious blood with stool most of the time~Blood alone passes~Endoscopic findings (subscore 0-3) 0: Normal or inactive disease~1 Mild Disease (erythema, decreased vascular pattern, mild friability) 2: Moderate Disease (marked erythema, lack of vascular pattern, friability erosions) 3: Severe Disease (spontaneous bleeding, ulceration)~Physician's Global Assessment (subscore 0-3) 0: Normal~Mild disease~Moderate disease~Severe disease"|From Baseline to day 34 (end of treatment period)||||participants|||Number
2668424|NCT01506323|Secondary|Five Facet Mindfulness Questionnaire (FFMQ)|FFMQ a 39-item scale that measures five components of mindfulness: observing; describing; acting with awareness; non-judging of inner experience; and non-reactivity to inner experience. Each subscale contains either 7 or 8 items that are rated on a 1 (never or very rarely true) to 5 (very often or always true) Likert scale. Items are randomly reversed scored and higher scores represent greater levels of mindfulness. Total scores range from 39 to 195.|Baseline to post-treatment (week 8); baseline to 2-months follow-up.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
2668425|NCT01506323|Secondary|Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing Scale-Expanded (FACIT-SpEx)|The FACIT-SpEx was developed to assess spiritual components (e.g., harmony, meaning, purpose in life, peacefulness, faith/assurance) of quality of life using 23 items rated on a 5-point Likert scale from 0 (not at all) to 4 (very much). Total scores range from 0 to 92. Higher scores indicating greater spiritual well-being. Validity has been demonstrated by significant Pearson correlations between measures of quality of life, mood, and religious growth. It has demonstrated internal consistency reliability.|Baseline to post-treatment (week 8); baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
2668426|NCT01506323|Secondary|Spielberger Trait Anger Inventory-Short Form|Spielberger Trait Anger Inventory-Short Form is a 10-item questionnaire with 4-point Likert scale used to measure anger as a personality trait. Scores range from 10 to 40 with higher scores indicating more trait anger. Concurrent validity has been supported by correlations with measures of hostility, neuroticism, and anxiety. Internal consistency reliability has been reported as good to excellent.|Baseline to post-treatment (week 8); baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
2668427|NCT01506323|Primary|PTSD Checklist-Military Version [Diagnostic and Statistical Manual (DSM) IV-TR Version]|PCL-M: PTSD Checklist-Military version (PCL-M) is a 17-item self-report screening instrument for PTSD symptoms related to military trauma. Items are scored on a 1 (not at all bothersome) to 5 (extremely bothersome) Likert scale. Total scores range from 17 to 85. Higher scores indicate greater symptom bothersomeness. A score of > 50 can suggest PTSD Test-retest reliability is high (r = 0.96) and validity is adequate, with a Kappa of 0.64 agreement for PTSD diagnosis compared to the Structured Clinical Interview for DSM-IV.|Baseline to post-treatment (week 8); Baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
2668428|NCT01506323|Secondary|Spielberger State Anger Inventory-Short Form|Spielberger State Anger Inventory-Short Form is a 10-item questionnaire with 4-point Likert scale to measure anger as an emotional state. Scores range from 10 to 40 with higher scores indicating more anger. Concurrent validity has been supported by correlations with measures of hostility, neuroticism, and anxiety. Internal consistency reliability has been reported as good to excellent.|Baseline to post-treatment (week 8); baseline to 2-months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
2668468|NCT01505881|Secondary|Percentage of Patients With AEs Leading to Discontinuation of Trial Drug|"Percentage of patients with Adverse Events leading to discontinuation of trial drug.~Prespecified clinical outcome events were not recorded as Adverse Events."|From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)|Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug|||percentage of participants|||Number
2668430|NCT01506323|Secondary|Insomnia Severity Index (ISI)|ISI is a widely used measure of insomnia with well-established reliability and validity. It consists of seven items, three of which assess severity of insomnia (i.e., degree of difficulty falling asleep, staying asleep, and waking too early). The remaining questions tap satisfaction with sleep pattern, effect of sleep on daytime and social functioning, and concern about current sleep difficulties. Both categorical and continuous measures of sleep difficulties can be assessed. Items are rated on a 0-4 Likert scale with higher scores meaning greater insomnia. Total scores range from 0-28. Original results were interpreted as 0-7 = no clinically significant insomnia, 8-14 = sub-threshold insomnia, 15-21 = moderately severe clinical insomnia and 21-28 = severe clinical insomnia. Later recommendations for a clinical, not community sample, are a cut-off of 11 points.|Baseline to post-treatment (week 8); baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 70 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
2668431|NCT01506323|Primary|Hyperarousal (Criterion D) on the Clinician Administered PTSD Scale (CAPS)|This subscale measures the frequency and intensity of increased arousal as indicated by two or more of the following: (1) difficulty falling or staying asleep, (2) irritability or outbursts of anger, (3) difficulty concentrating, (4) hypervigilance, and/or (5) exaggerated startle response. Duration of these symptoms is greater than one month and causes clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores range from 0 to 40. Higher scores indicate greater severity of symptoms.|Baseline to post-treatment (week 8); baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
2668432|NCT01506323|Primary|Avoidance Subscale (Criterion C) on the Clinician Administered PTSD Scale (CAPS)|This subscale measures the frequency and intensity of persistent avoidance of stimuli associated with the trauma and numbing of general responsiveness as indicated by 3 or more of the following: (1) efforts to avoid thoughts, feelings, or conversations associated with the trauma, (2) efforts to avoid activities, places or people that arouse recollections of the trauma, (3) inability to recall an important aspect of the trauma, (4) markedly diminished interest or participation in significant activities, (5) feelings of detachment or estrangement from others, (6) restricted range of affect, and/or (7) sense of a foreshortened future. Duration of these symptoms is greater than one month and causes clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores range from 0 to 56 with higher scores indicating greater severity of avoidance.|Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
2668433|NCT01506323|Primary|Re-experiencing Subscale (Criterion B) on the Clinician Administered PTSD Scale (CAPS)|This subscale measures the frequency and intensity of (1) recurrent or intrusive recollections of trauma, (2) recurrent, distressing dreams of the trauma, (3) acting as if the traumatic event were recurring like a flashback, (4) intense psychological distress at exposure to internal or external cues that resemble the trauma; and/or (5) physiological reactivity on exposure to internal or external cues that symbolize or resemble an aspect of the trauma. Duration of these symptoms is greater than one month and symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores can range from 0 to 40 and higher scores mean greater severity of re-experiencing.|Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
2668434|NCT01506323|Primary|Clinician-Administered PTSD Scale (CAPS) Diagnostic and Statistical Manual, 4th ed., Text Revision (DSM-IV)|PTSD symptom severity is measured by CAPS to determine PTSD diagnosis. The scale rates 17 items representing the Diagnostic and Statistical Manual IV (DSM-IV) criteria B (re-experiencing), C (avoidance/numbing) and D (hyper-arousal). CAPS has demonstrated high levels of internal consistency, good inter-rater reliability, & excellent convergent validity. The F1/I2 rule will be applied to establish the diagnosis of PTSD aligned with DSM-IV (e.g. one symptom of Criterion B, three of Criterion C, and two of Criterion D. The CAPS also includes an item to assess duration of PTSD symptoms. CAPS total score ranges from 0-136 with higher scores indicating greater symptom severity.|Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.|Intent to treat analysis included 89 MRP and 84 PCT participants. Completers at post-treatment included 69 MRP and 72 PCT participants. Completers at 2-months follow up included 65 MRP and 71 PCT participants.|||units on a scale||Standard Deviation|Mean
2668435|NCT01506271|Primary|Percentage of Participants With System Organ Class (SOC) With AEs With Incidence of >= 4 Participants in One Treatment Group|A system organ class (SOC) is the highest level of terminology used to describe disorders of the human body, and distinguishes by either anatomical or physiological systems, disease origin or purpose. SOCs with AE incidence greater than or equal to 4 in one treatment group are presented. SOCs with AE incidence which did not achieve this threshold are not reported. SOCs are based on MedDRA version 17.0.|Up to 42 days following completion of all study therapy (up to Day 56)|All randomized participants who received at least one dose of IV study therapy, based on the therapy they actually received|||Percentage of participants|||Number
2668436|NCT01506271|Primary|Percentage of Participants With Predefined Limit of Change (PDLC) With Incidence of >= 4 Participants in One Treatment Group|Predefined limit of change (PDLC) are presented based on values from the following laboratory tests on serum: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (Bil), and alkaline phosphatase (AP). Results are presented for PDLC from tests with reported incidence greater than or equal to 4 participants in one treatment group. Laboratory tests which did not achieve the PDLC threshold are not reported.|Up to 42 days following completion of all study therapy (up to Day 56)|All randomized participants who received at least one dose of IV study therapy, based on the therapy they actually received|||Percentage of participants|||Number
2669104|NCT01498991|Secondary|Vibration Threshold Test||Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).|The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.||||||
2668437|NCT01506271|Secondary|Percentage of Participants With a Favorable Microbiological Response at Late Follow-up|A favorable microbiological response is assessed by the clinical investigator, and is defined as the eradication or presumptive eradication of all bacterial pathogens identified at baseline.|Up to 42 days following completion of all study therapy (up to Day 56)|Met the protocol definition of cIAI; had a pre-study/post operative culture from the site of infection grew at least one Gram-negative enteric and/or anaerobic pathogen; had no significant deviations from the protocol that could impact the efficacy assessment; and received ≥ 96 hours of IV study therapy.|||Percentage of participants||95% Confidence Interval|Number
2668438|NCT01506271|Secondary|Percentage of Participants With a Favorable Clinical Response at Late Follow-up|A favorable clinical response is assessed by the clinical investigator as a cure, and is defined as a situation where all or most pre-therapy signs and symptoms of the index infection have resolved, or returned to pre-infection status, and no additional antibiotic therapy is required.|Up to 42 days following completion of all study therapy (up to Day 56)|Met the protocol definition of cIAI; had a pre-study/post operative culture from the site of infection grew at least one Gram-negative enteric and/or anaerobic pathogen; had no significant deviations from the protocol that could impact the efficacy assessment; and received ≥ 96 hours of IV study therapy.|||Percentage of participants||95% Confidence Interval|Number
2668439|NCT01506271|Secondary|Percentage of Participants With a Favorable Microbiological Response at Early Follow-up|A favorable microbiological response is assessed by the clinical investigator, and is defined as the eradication or presumptive eradication of all bacterial pathogens identified at baseline.|Up to 9 days following completion of all study therapy (up to Day 23)|Met the protocol definition of cIAI; had a pre-study/post operative culture from the site of infection grew at least one Gram-negative enteric and/or anaerobic pathogen; had no significant deviations from the protocol that could impact the efficacy assessment; and received ≥ 96 hours of IV study therapy.|||Percentage of participants||95% Confidence Interval|Number
2668440|NCT01506271|Secondary|Percentage of Participants With a Favorable Microbiological Response at Completion of IV Study Therapy|A favorable microbiological response is assessed by the clinical investigator, and is defined as the eradication or presumptive eradication of all bacterial pathogens identified at baseline.|Up to 14 days post initiation of IV study therapy (up to postrandomization day 14)|Met the protocol definition of cIAI; had a pre-study/post operative culture from the site of infection grew at least one Gram-negative enteric and/or anaerobic pathogen; had no significant deviations from the protocol that could impact the efficacy assessment; and received ≥ 96 hours of IV study therapy.|||Percentage of participants||95% Confidence Interval|Number
2668441|NCT01506271|Secondary|Percentage of Participants With a Favorable Clinical Response at Early Follow-up|A favorable clinical response is assessed by the clinical investigator as a cure, and is defined as a situation where all or most pre-therapy signs and symptoms of the index infection have resolved, or returned to pre-infection status, and no additional antibiotic therapy is required.|Up to 9 days following completion of all study therapy (up to Day 23)|Met the protocol definition of cIAI; had a culture from the site of infection, that grew Gram-negative pathogen; had no significant deviations from the protocol that could impact the efficacy assessment; received ≥ 96 hours of IV study therapy.|||Percentage of participants||95% Confidence Interval|Number
2668442|NCT01506271|Secondary|Percentage of Participants With a Favorable Clinical Response at Completion of IV Study Therapy in Participants Who Have Imipenem-resistant, Gram-negative cIAI Infections.|A favorable clinical response is assessed by the clinical investigator as a cure, and is defined as a situation where all or most pre-therapy signs and symptoms of the index infection have resolved, or returned to pre-infection status, and no additional antibiotic therapy is required.|4 to 14 days post initiation of IV study therapy (up to postrandomization day 14).|Met the protocol definition of cIAI; had a culture from the site of infection, that grew Gram-negative pathogen; had no significant deviations from the protocol that could impact the efficacy assessment; received ≥ 96 hours of IV study therapy; and had imipenem-resistant, gram negative cIAI infections.|||Percentage of participants||95% Confidence Interval|Number
2668443|NCT01506271|Primary|Percentage of Participants With Specific AEs With Incidence of >= 4 Participants in One Treatment Group|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an AE. AE preferred terms, with incidence greater than or equal to 4 in one treatment group are presented. AEs preferred terms which did not achieve this threshold are not reported. AE preferred terms are based on MedDRA version 17.0.|Up to 42 days following completion of all study therapy (up to Day 56)|All randomized participants who received at least one dose of IV study therapy, based on the therapy they actually received|||Percentage of participants|||Number
2668444|NCT01506271|Primary|Percentage of Participants Who Discontinued IV Study Therapy Due to a Drug-related AE|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an AE. A drug-related AE is an AE determined by the investigator to be possibly, probably or definitely related to drug treatment. Drug-related AEs assessed by the investigator that caused discontinuation of participant treatment are presented.|Up to 14 days post initiation of IV study therapy (up to 14 days)|All randomized participants who received at least one dose of IV study therapy, based on the therapy they actually received|||Percentage of participants|||Number
2668445|NCT01506271|Primary|Percentage of Participants Who Discontinued IV Study Therapy Due to an AE|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an AE. AEs assessed by the investigator that caused discontinuation of participant treatment are presented.|Up to 14 days post initiation of IV study therapy (up to 14 days)|All randomized participants who received at least one dose of IV study therapy, based on the therapy they actually received|||Percentage of participants|||Number
2668446|NCT01506271|Primary|Percentage of Participants With Any Drug-related SAE|A SAE is any AE occurring at any dose that is life threatening; results in a persistent or significant disability/incapacity; prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; or results in death. A drug-related SAE is a SAE determined by the investigator to be possibly, probably or definitely related to drug treatment.|Up to 42 days following completion of all study therapy (up to Day 56)|All randomized participants who received at least one dose of IV study therapy, based on the therapy they actually received|||Percentage of participants|||Number
2668447|NCT01506271|Primary|Percentage of Participants With Any Drug-related AE|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an AE. A drug-related AE is a AE determined by the investigator to be possibly, probably or definitely related to drug treatment.|Up to 14 days following completion of all study therapy (up to Day 28)|All randomized participants who received at least one dose of IV study therapy, based on the therapy they actually received|||Percentage of participants|||Number
2668448|NCT01506271|Primary|Percentage of Participants With Any Serious Adverse Event (SAE)|A serious adverse event (SAE) is any AE occurring at any dose that is life threatening; results in a persistent or significant disability/incapacity; prolongs an existing inpatient hospitalization; is a congenital anomaly/birth defect; or results in death.|Up to 14 days following completion of all study therapy (up to Day 28)|All randomized participants who received at least one dose of IV study therapy, based on the therapy they actually received|||Percentage of participants|||Number
2668449|NCT01506271|Primary|Percentage of Participants With Any Adverse Event (AE)|An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the medicinal product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the medicinal product, is also an AE.|Up to 14 days following completion of all study therapy (up to Day 28)|All randomized participants who received at least one dose of IV study therapy, based on the therapy they actually received|||Percentage of participants|||Number
2668450|NCT01506271|Primary|Percentage of Participants With Elevated AST or ALT Laboratory Values >= 3X the ULN, Total Bilirubin >= 2X the ULN, and Alkaline Phosphatase Values < 2X the ULN|Pre-specified events of interest were a confirmed (i.e., verified by repeat testing) elevated AST or ALT laboratory value that is greater than or equal to 3X ULN, as well as elevated total bilirubin greater than or equal to 2X the ULN, and alkaline phosphatase values that are less than 2X the ULN, as a result of within-protocol-specific testing or unscheduled testing.|Up to 14 days following completion of all study therapy (up to Day 28)|All randomized participants who received at least one dose of IV study therapy, based on the therapy they actually received|||Percentage of participants|||Number
2668451|NCT01506271|Primary|Percentage of Participants With an Elevated Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) Laboratory Values That Are Greater Than or Equal to 5X the Upper Limit of Normal (ULN)|Pre-specified events of interest were confirmed (i.e., verified by repeat testing) elevated AST or ALT laboratory value that is greater than or equal to 5 X ULN as a result of within-protocol-specific testing or unscheduled testing.|Up to 14 days following completion of all study therapy (up to Day 28)|All randomized participants who received at least one dose of IV study therapy, based on the therapy they actually received|||Percentage of participants|||Number
2668452|NCT01506271|Primary|Percentage of Participants With a Favorable Clinical Response at Completion of IV Study Therapy|A favorable clinical response was assessed by the clinical investigator as a cure, and was defined as a situation where all or most pre-therapy signs and symptoms of the index infection had resolved, or returned to pre-infection status, and no additional antibiotic therapy was required.|4 to 14 days post initiation of intravenous (IV) study therapy (up to postrandomization Day 14)|Those who had cIAI; a culture from the infection that grew one Gram negative pathogen; no protocol deviations; received ≥ 96 hours of IV therapy. Two participants treated with relebactam 250 mg, one with relebactam 125 mg, and two with placebo, all with indeterminate or missing responses, were excluded from the analysis.|||Percentage of participants||95% Confidence Interval|Number
2668453|NCT01506193|Secondary|Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses|Antibody titers were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs) for the following cut-offs: ≥ 150 mIU/mL, ≥ 231 U/mL, ≥ 4 IU/mL and ≥ 25 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella, respectively.|At Day 42 after vaccination|The analysis was performed on the ATP cohort for immunogenicity post-dose 1 which included all eligible subjects with post-dose 1 serology results available for at least one antigen, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood drawn.|||Titers||95% Confidence Interval|Geometric Mean
2668454|NCT01506193|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout study period (from Day 0 to approximately Month 4)|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.|||Participants|||Count of Participants
2668455|NCT01506193|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 43 days (Days 0-42) after each vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.|||Participants|||Count of Participants
2668469|NCT01505881|Primary|Percentage of Patients With Any Adverse Event (AE)|Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events.|From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)|Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug|||percentage of participants|||Number
2668456|NCT01506193|Secondary|Number of Subjects Reporting Any, Localised and Generalised Rashes|Rash/exanthem was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin's surface. 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin's surface or other types of rash (heat rash, diaper rash etc.). Any rash = no lesions and grade 3 = > 150 lesions.|Within the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets for rash completed.|||Participants|||Count of Participants
2668457|NCT01506193|Secondary|Number of Subjects Reporting Fever Per Half Degree|Any fever = fever ≥ 38.0°C on rectal setting, grade 3 fever = fever > 39.5 °C and related = fever assessed by the investigator as causally related to study vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.|||Participants|||Count of Participants
2668458|NCT01506193|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were Parotid / salivary gland swelling and suspected signs of meningism / febrile convulsions. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 parotid / salivary gland swelling = swelling with accompanying general symptoms and Related = symptom assessed by the investigator as related to the vaccination.|During the 43-day (Days 0-42) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.|||Participants|||Count of Participants
2668459|NCT01506193|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.|During the 15-day (Days 0-14) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.|||Participants|||Count of Participants
2668460|NCT01506193|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. This outcome measure concerns subjects in Priorix-Tetra + Meningitec Group and Priorix-Tetra Group only. Subjects in Priorix-Tetra Group did not receive Meningitec® vaccine.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.|||Participants|||Count of Participants
2668461|NCT01506193|Primary|Number of Seroprotected Subjects for rSBA-MenC Antibodies|Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.|At 42 days after vaccination|The analysis was performed on all eligible subjects with post-dose 1 serology results available for at least one antigen in this analysis, included in the ATP cohort for immunogenicity post-dose 1, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood draw.|||Participants|||Count of Participants
2668462|NCT01506193|Primary|Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus|Seroconversion was defined as the appearance of antibodies (i.e. concentration/titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for serocoversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and 25 mIU/mL for measles, mumps, rubella and varicella, respectively.|At 42 days after vaccination|The analysis was performed on all eligible subjects with post-dose 1 serology results available for at least one antigen in this analysis, included in the ATP cohort for immunogenicity post-dose 1, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood draw.|||Participants|||Count of Participants
2668463|NCT01505933|Secondary|Transverse Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis|At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged|When the the expired sevoflurane is 0% during the procedure on an average of 5 - 10 min after discontinuation of sevoflurane, measurement will be obtained||||mm||Standard Deviation|Mean
2668464|NCT01505933|Secondary|Anteroposterior Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis|At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged|When the the expired sevoflurane is 0% during the procedure on an average of 5 - 10 min after discontinuation of devoflurane, measurement will be obtained||||mm||Standard Deviation|Mean
2668465|NCT01505933|Primary|Cross-sectional Area (CSA) of the Upper Airway at the Level of Soft Palate, Base of the Tongue and Tip of the Epiglottis|At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged.|When expired sevoflurane is 0% during the procedure on an average of 5 - 10 mins after discontinuation of sevoflurane, airway measurements will be done||||mm2||Standard Deviation|Mean
2668466|NCT01505881|Secondary|Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.|"Clinical efficacy outcome events presented are:~Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, Systemic embolism and Valve thrombosis"|From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)|Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug|||percentage of participants|||Number
2668467|NCT01505881|Secondary|Percentage of Patients With Serious AEs|Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events.|From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)|Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug|||percentage of participants|||Number
2668482|NCT01505673|Secondary|Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment|Willingness to continue insulin treatment was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely willing to 7 - not at all willing.|6 months||||score on a scale||Standard Deviation|Mean
2668483|NCT01505673|Secondary|Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment|Satisfaction with insulin treatment was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1 to 7, where 1 extremely satisfied to 7 - not at all satisfied.|6 months||||score on a scale||Standard Deviation|Mean
2668484|NCT01505673|Secondary|Quality of Life Survey (QoL) - Social Stigma|Social stigma was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1 strongly agree; 2 - somewhat agree; 3 - neither agree nor disagree; 4 - somewhat disagree; 5 - strongly disagree.|6 months||||score on a scale||Standard Deviation|Mean
2668485|NCT01505673|Secondary|Quality of Life Survey (QoL) - Lifestyle Flexibility|Lifestyle flexibility was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1 to 5, where 1 - a great deal of choice; 2 - a lot of choice; 3 - some choice; 4 - a little choice; 5 - no choice.|6 months||||score on a scale||Standard Deviation|Mean
2668486|NCT01505673|Secondary|Quality of Life Survey (QoL) - Glycemia Control Perception|Glycemia control perception was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a scale score of 1-7, where 1 - extremely controlled and 7 - not at all controlled.|6 months||||score on a scale||Standard Deviation|Mean
2668487|NCT01505673|Secondary|Quality of Life Survey (QoL) - Hypoglycemia Fear|Hypoglycemia fear was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - never worry; 2 - rarely water; 3 - sometimes worry; 4 - often worry; 5 - very often worry.|6 months||||score on a scale||Standard Deviation|Mean
2668488|NCT01505673|Secondary|Quality of Life Survey (QoL) - Social or Vocational Worry|Social or vocational worry was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 0-5, where 0 - does not apply; 1 - never; 2 - seldom; 3 - sometimes; 4 - often; 5 - all of the time.|6 months||||score on a scale||Standard Deviation|Mean
2668489|NCT01505673|Secondary|Quality of Life Survey (QoL) - Treatment Impact|Treatment impact was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied.|6 months||||score on a scale||Standard Deviation|Mean
2668490|NCT01505673|Secondary|Quality of Life Survey (QoL) - Treatment Satisfaction|Quality of Life Survey (QoL) - treatment satisfactionTreatment satisfaction was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 - very satisfied; 2 - moderately satisfied; 3 - neither satisfied nor dissatisfied; 4 - moderately dissatisfied; 5 - very dissatisfied.|6 months||||score on a scale||Standard Deviation|Mean
2668491|NCT01505673|Secondary|Quality of Life Survey (QoL) - Current Health Perception|Current health perception was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 = much better than 3 months ago; 2 - Somewhat better now than 3 months ago; 3 - About the same; 4 - Somewhat worse now than 3 months ago; 5 Much worse now than 3 months ago.|6 months||||score on a scale||Standard Deviation|Mean
2668492|NCT01505673|Secondary|AUC Glucose||6 months||||mg/(dL/min)||Standard Deviation|Mean
2668493|NCT01505673|Secondary|Ratio (AUC C-peptide/AUC Glucose)||6 months||||Ratio||Standard Deviation|Mean
2668494|NCT01505673|Secondary|Beta-cell Function|AUC c-peptide|6 Months||||ug/(L/min)||Standard Deviation|Mean
2668495|NCT01505673|Secondary|Matsuda Index as a Measure of Beta Cell Function|The Matsuda index is a measure of insulin sensitivity and has no minimum/maximum values. Index values are calculated as 500,000/square root of ((fasting glucose x fasting c-peptide x 333) x (mean 120 min post-meal glucose x mean 120 min post-meal c-peptide x 333)). Higher/lower values = better/worse insulin sensitivity.|6 months||||index||Inter-Quartile Range|Mean
2668496|NCT01505673|Secondary|Beta-Cell Function|Fasting C-peptide as a Measure of Beta-Cell Function|6 months||||microgram/L||Standard Deviation|Mean
2668497|NCT01505673|Secondary|Quality of Life Survey (QoL) - General Health Perception|General health perception was measured at randomization and 6 months later using the modified Diabetes Quality of Life Clinical Trial Questionnaire. This questionnaire addresses several areas with respect to diabetes QoL. Answers are in the form of a Likert scale score of 1-5, where 1 = excellent; 2 = very good; 3 = good; 4 = fair; 5 = poor.|6-months||||score on a scale||Standard Deviation|Mean
2668498|NCT01505673|Secondary|Hypoglycemic Events|Reported as hypoglycemic events per month by patient as any blood glucose <70 mg/dl or symptoms of hypoglycemia with blood glucose >70 mg/dl|6-months||||events per month per patient||Inter-Quartile Range|Median
2668499|NCT01505673|Secondary|Liver Function Blood Test||6-months||||U/L||Standard Deviation|Mean
2668500|NCT01505673|Secondary|Lipid Profile||6-months||||mg/dL||Standard Deviation|Mean
2668501|NCT01505673|Secondary|Blood Pressure||6-months||||mmHg||Standard Deviation|Mean
2668509|NCT01505647|Secondary|Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination|"An SAE is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement"|Day 1 to Day 182 postvaccination|Analysis included all vaccinated participants with safety follow-up data. One participant in the AMP vaccine group was vaccinated but lost to follow-up without safety follow-up.|||Participants|||Number
2668510|NCT01505647|Secondary|Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination|"An SAE is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement"|Day 1 to Day 42 postvaccination|Analysis included all vaccinated participants with safety follow-up data. One participant in the AMP vaccine group was vaccinated but lost to follow-up without safety follow-up.|||Participants|||Number
2668511|NCT01505647|Secondary|Number of Participants With One or More Adverse Experiences (AEs)|"An AE is defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience."|Day 1 to Day 42 postvaccination|Analysis included all vaccinated participants with safety follow-up data. One participant in the AMP vaccine group was vaccinated but lost to follow-up without safety follow-up.|||Participants|||Number
2668512|NCT01505647|Primary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers|VZV antibody titers were determined by gpELISA. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 6 / Day 1 (Baseline).|Day 1 (Baseline) to Week 6 postvaccination|Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of antibody response, developed suspected varicella or herpes zoster rashes before blood sampling, or reported an exposure to varicella or herpes zoster.|||Ratio||95% Confidence Interval|Geometric Mean
2668513|NCT01505647|Primary|Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody|VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)|Day 1 and Week 6 postvaccination|Analysis included all vaccinated participants except those who had protocol deviations that interfered with the assessment of antibody response, developed suspected varicella or herpes zoster rashes before blood sampling, or reported an exposure to varicella or herpes zoster|||Units/mL||95% Confidence Interval|Geometric Mean
2668514|NCT01505634|Secondary|Percentage of Participants With a Favorable Microbiological Response at Late Follow-up|"Microbiological response was assessed based on results of bacterial cultures obtained up to 42 days following completion of all study medication (IV and oral) relative to cultures obtained at baseline. A favorable microbiological response was defined as eradication of all pathogens identified at baseline. Microbiological response was assessed separately for each participant and pathogen identified in the ME population that included participants with a urine culture confirmed to be positive for at least 1 gram-negative and/or anaerobic pathogen(s) commonly isolated in UTI. The overall microbiological response was determined as favorable if all pathogens isolated from a participant at baseline demonstrated a favorable response (eradication) at the time point evaluated."|Up to 42 days following completion of all study IV and oral therapy (up to Day 56)|All participants in the ME population with non-missing/non-indeterminate response.|||Percentage of participants||95% Confidence Interval|Number
2668515|NCT01505634|Secondary|Percentage of Participants With a Favorable Clinical Response at Late Follow-up|Clinical response was assessed as favorable (cured or improved) or unfavorable (failure) relative to baseline. Response determination was based on physical findings including fever (or history of fever), chills or rigors (accompanied by fever), flank pain, costovertebral angle tenderness, dysuria, urinary urgency, urinary frequency, suprapubic or pelvic pain, nausea, or vomiting. Clinical response was assessed in the ME population that included participants with a urine culture confirmed to be positive for at least 1 gram-negative and/or anaerobic pathogen(s) commonly isolated in UTI.|Up to 42 days following completion of all study IV and oral therapy (up to Day 56)|All participants in the ME population with non-missing/non-indeterminate response.|||Percentage of participants||95% Confidence Interval|Number
2668516|NCT01505634|Secondary|Percentage of Participants With a Favorable Clinical Response at Early Follow-up|Clinical response was assessed as favorable (cured or improved) or unfavorable (failure) relative to baseline. Response determination was based on physical findings including fever (or history of fever), chills or rigors (accompanied by fever), flank pain, costovertebral angle tenderness, dysuria, urinary urgency, urinary frequency, suprapubic or pelvic pain, nausea, or vomiting. Clinical response was assessed in the ME population that included participants with a urine culture confirmed to be positive for at least 1 gram-negative and/or anaerobic pathogen(s) commonly isolated in UTI.|Up to 9 days following completion of all study IV and oral therapy (up to Day 23)|All participants in the ME population with non-missing/non-indeterminate response.|||Percentage of Participants||95% Confidence Interval|Number
2668517|NCT01505634|Secondary|Percentage of Participants With a Favorable Clinical Response at Completion of IV Study Therapy|Clinical response was assessed as favorable (cured or improved) or unfavorable (failure) relative to baseline. Response determination was based on physical findings including fever (or history of fever), chills or rigors (accompanied by fever), flank pain, costovertebral angle tenderness, dysuria, urinary urgency, urinary frequency, suprapubic or pelvic pain, nausea, or vomiting. Clinical response was assessed in the ME population that included participants with a urine culture confirmed to be positive for at least 1 gram-negative and/or anaerobic pathogen(s) commonly isolated in UTI.|At time of last IV dose of study drug (up to postrandomization day 14)|All participants in the ME population with non-missing/nonindeterminate response.|||Percentage of participants||95% Confidence Interval|Number
2668595|NCT01504958|Secondary|Clinical Global Impression of Change (CGIC)|The CGI is a three-item scale used to assess treatment response in psychiatric patients. The CGI-C subset measures the global improvement or change from baseline. Scores range from 0 to 7, with 0 indicating marked improvement and 7 indicating marked worsening. The scores below represent the percent change of the scores from baseline.|Pre-treatment, 1 month post treatment||||percent change||Standard Deviation|Mean
2668518|NCT01505634|Secondary|Percentage of Participants With a Favorable Microbiological Response at Early Follow-up|"Microbiological response was assessed based on results of bacterial cultures obtained up to 9 days following completion of all study medication (IV and oral) relative to cultures obtained at baseline. A favorable microbiological response was defined as eradication of all pathogens identified at baseline. Microbiological response was assessed separately for each participant and pathogen identified in the ME population that included participants with a urine culture confirmed to be positive for at least 1 gram-negative and/or anaerobic pathogen(s) commonly isolated in UTI. The overall microbiological response was determined as favorable if all pathogens isolated from a participant at baseline demonstrated a favorable response (eradication) at the time point evaluated."|Up to 9 days following completion of all study IV and oral therapy (up to Day 23)|All participants in the ME population with non-missing/non-indeterminate response.|||Percentage of participants||95% Confidence Interval|Number
2668519|NCT01505634|Secondary|Percentage of Participants With a Favorable Microbiological Response at Completion of IV Study Therapy Who Had Imipenem-resistant, Gram-negative cUTI Infections.|"Microbiological response was assessed based on results of bacterial cultures obtained at completion of IV study medication relative to cultures obtained at baseline. A favorable microbiological response was defined as eradication of all pathogens identified at baseline. Microbiological response was assessed separately for each participant and pathogen identified in the Microbiologically Evaluable (ME) population that included participants with a urine culture confirmed to be positive for imipenem-resistant gram-negative or anaerobic infections at baseline. The overall microbiological response was determined as favorable if all pathogens isolated from a participant at baseline demonstrated a favorable response (eradication) at the time point evaluated."|At time of last IV dose of study drug (up to post-randomization day 14)|All participants in the ME population with imipenem-resistant gram-negative infections at baseline.|||Percentage of participants||95% Confidence Interval|Number
2668520|NCT01505634|Primary|Percentage of Participants With Specific AEs With Incidence of >= 4 Participants in One Treatment Group|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. Analysis includes specific adverse events with an incidence of ≥4 participants in one treatment group or system organ class.|Up to 14 days following completion of all study therapy (up to 28 days)|All randomized participants who received ≥1 dose of study treatment.|||Percentage of participants|||Number
2668521|NCT01505634|Primary|Percentage of Participants Who Discontinued IV Study Therapy Due to a Drug-related AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A drug-related AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product that the investigator determined to be possibly, probably, or definitely related to the treatment.|Up to 14 days|All randomized participants who received ≥1 dose of study treatment.|||Percentage of participants|||Number
2668522|NCT01505634|Primary|Percentage of Participants Who Discontinued IV Study Therapy Due to an AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a pre-existing condition temporally associated with the use of the product was also an AE.|Up to 14 days|All randomized participants who received ≥1 dose of study treatment.|||Percentage of participants|||Number
2668523|NCT01505634|Primary|Percentage of Participants With a Drug-related SAE|A serious, drug-related (DR) AE was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event. The SAE was determined to be possibly, probably, or definitely related to the treatment by the investigator.|Up to 42 days following completion of all study therapy (up to 56 days)|All randomized participants who received ≥1 dose of study treatment.|||Percentage of participants|||Number
2668524|NCT01505634|Primary|Percentage of Participants With Any Drug-related AE|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A drug-related (DR) AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product that the investigator determined to be possibly, probably, or definitely related to the treatment.|Up to 14 days following completion of all study therapy (up to 28 days)|All randomized participants who received ≥1 dose of study treatment.|||Percentage of participants|||Number
2668525|NCT01505634|Primary|Percentage of Participants With Any Serious Adverse Event (SAE)|A SAE was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.|Up to 14 days following completion of all study therapy (up to 28 days)|All randomized participants who received ≥1 dose of study treatment.|||Percentage of participants|||Number
2669105|NCT01498991|Primary|Gait Velocity|Measured by the GAITRite system|Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).|The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.||||||
2668526|NCT01505634|Primary|Percentage of Participants With at Least 1 Adverse Event (AE)|An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.|Up to 14 days following completion of all study therapy (up to 28 days)|All randomized participants who received ≥1 dose of study treatment.|||Percentage of participants|||Number
2668527|NCT01505634|Primary|Percentage of Participants With Elevated AST or ALT Laboratory Values ≥ 3 Times the ULN, as Well as Elevated Total Bilirubin ≥ 2 Times the ULN, and Alkaline Phosphatase Values That Were < 2 Times the ULN|All randomized participants who received ≥1 dose of study treatment had AST, ALT, total bilirubin, and Alkaline Phosphatase (ALP) levels measured up to 14 days following completion of all study medication. Participants who had elevations of AST or ALT that were ≥3 times ULN, total bilirubin measurements that were ≥2 times ULN and, at the same time, an ALP measurement of < 2X ULN were recorded.|Up to 14 days following completion of all study therapy (up to 28 days)|All randomized participants who received ≥ 1 dose of study treatment.|||Percentage of participants|||Number
2668528|NCT01505634|Primary|Percentage of Participants With an Elevated Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) Laboratory Value That Was Greater Than or Equal to 5 Times the Upper Limit of Normal (ULN)|All randomized participants who received ≥1 dose of study treatment had AST and ALT levels measured up to 14 days following completion of all study medication. Participants who had 2 confirmed elevations of either AST or ALT that were 5 times ULN or greater were recorded.|Up to 14 days following completion of all study therapy (up to 28 days)|All randomized participants who received ≥ 1 dose of study treatment.|||Percentage of participants|||Number
2668529|NCT01505634|Primary|Percentage of Participants With a Favorable Microbiological Response at Completion of IV Study Therapy|"Microbiological response (MR) was assessed based on results of bacterial cultures obtained at completion of IV study medication relative to cultures obtained at baseline. A favorable microbiological response was defined as eradication of all pathogens identified at baseline. Microbiological response was assessed separately for each participant and pathogen identified in the Microbiologically Evaluable (ME) population that included participants with a urine culture confirmed to be positive for at least 1 gram-negative and/or anaerobic pathogen(s) commonly isolated in UTI. The overall microbiological response was determined as favorable if all pathogens isolated from a participant at baseline demonstrated a favorable response (eradication) at the time point evaluated."|At time of last IV dose of study drug (up to post-randomization day 14)|All participants in the ME population with non-missing/non-indeterminate response.|||Percentage of Participants||95% Confidence Interval|Number
2668530|NCT01505608|Secondary|Median Overall Survival (OS) of Participants|To determine OS and clinical benefit (CR/PR/SD) in this population|3 years|Not evaluated due to early closure. Study data does not exist.||||||
2668531|NCT01505608|Secondary|Progression Free Survival (PFS) of Participants Using Days Until Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|3 years|Arm A- 2 subjects randomized to TMZ+I. Arm B- 6 evalubale patients in Phase 1 + 4 evaluable patients in Phase 2- all received TMZ+I+TPI|||Days|||Number
2668532|NCT01505608|Secondary|Measure Quality of Life of Children Receiving TPI287 Using PedsQL Questionnaires|Evaluate the impact on QOL of children receiving TPI+I+TMZ|3 years|QOL's not collected due to early closure of study. Data not collected or analyzed threfore no data exists.||||||
2668533|NCT01505608|Secondary|Pharmacokinetics (PK) of TPI 287 in the Phase I Population of This Trial.|To evaluate the drug levels and pharmacokinetics (PK) of TPI 287 from blood samples at multiple time points within the first 24 hours on study.|1 year|PK's not run due to early closure of study. Data not collected or analyzed threfore no data exists.||||||
2668534|NCT01505608|Primary|Overall Response Rate (ORR) of Participants Using RECIST Criteria|"Phase I portion of trial- All patients enrolled to recieve TPI+I+TMZ. These patients will be added to the Phase II patients that were randomized to Arm B- Arm with TPI 287 (recieved same tx as Phase I participatns).~Phase II portion of trial- TPatients enrolled to this portion (different patients than enrolled to Phase 1) were randomized to Arm A: I+TMZ OR Arm B: TPI+I+TMZ Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|3 years|"8 enrolled to Phase 1: two were non-evaluable =6 move to analysis. Another 4 randomized to Arm B with TPI 287 in Phase 2=10 evaluable in TPI 287 analysis.~2 subjects were enrolled in the Phase 2 randomized portion of the trial to Arm A- without TPI 287. This makes 2 evaluable subjects in this analysis population (did not receive TPI 287)."|||participants|||Number
2668535|NCT01505608|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|"To determine the safety and tolerability of TPI 287 in combination with Irinotecan and Temozolomide (TPI+I+TMZ) in pediatric and young adult patients with primary refractory or recurrent Neuroblastoma.~Phase I patients were all enrolled to receive TPI 287. Phase 2 is where randomization began. Patients were different patients than the Phase 1 patients. Below all patients that received TPI 287 are included in the TPI 287 group. This includes Phase I patients and the Phase 2 patients randomized to TPI 287."|6 months|This group includes the 8 patients enrolled to phase 1 TPI 287 portion of the study plus the 4 additional patients randomized to TPI 287 in the Phase 2 portion = 12 patients total that received TPI 287 on this study.|||participants|||Number
2668536|NCT01505530|Secondary|Number of Participants With Anti-LY2495655 Antibodies||Cycle 1, Day 1 and Day 29 (Pre-Dose); Cycle 6 Day 1|All randomized participants.|||Participants|||Count of Participants
2668596|NCT01504958|Primary|Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)|Assessment to measure the severity of all of the most important symptoms of Alzheimer's disease: loss of memory, language, praxis, and attention. The total scoring range is 0-70, with 0 representing the least impairment and 70 the most severe impairment. The results posted below represent a change in score from baseline. A positive change represents an improvement on the ADAS-Cog (change = 1 month score - baseline score).|Pre treatment; 1 month post treatment||||percentage change||Standard Deviation|Mean
2668537|NCT01505530|Secondary|Change in Pain Scale Physical Functioning|The 36-item Short-Form Health Survey (SF-36) pain scale is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). The PCS physical functioning domain score ranges from 0 to 100 (higher scores indicate better health status).|Baseline, Cycles 2, 4, 6, 8 and 10; Day 1|All randomized participants with evaluable SF-36 domain scores.|||units on a scale||Standard Deviation|Mean
2668538|NCT01505530|Secondary|Change in Patient Reported Outcomes (PRO)|Data from PRO scales are not be presented. An error in coding the scales (coded differently early and late in the study) occurred. Unable to determine which results were affected therefore analysis not completed.|Baseline, Cycles 2, 4, 6, 8 and 10; Day 1|Zero participants analyzed. An error in coding the scales (coded differently early and late in the study) occurred. Unable to determine which results were affected therefore analysis not completed.||||||
2668539|NCT01505530|Secondary|Change in Physical Performance Measures Using Stair Climbing Time (StC)|Stair climbing time (StC) measured the ascend and descend of a flight of 12 steps (each step 18 cm high and 28 cm deep).|Baseline, Cycles 3, 5, 7, 9 and 11; Day 1|All participants that received at least one dose of study drug and had evaluable post-baseline measurements.|||joule/second||Standard Deviation|Mean
2668540|NCT01505530|Secondary|Change in Physical Performance Measures Using the 6 Minute Walk Test|The 6 minute walk test measured the distance walked in 6 minutes, as quickly as possible, without running.|Baseline, Cycles 2, 4, 6, 8 and 10; Day 1|All participants that received at least one dose of study drug and had evaluable post-baseline measurements.|||meter||Standard Deviation|Mean
2668541|NCT01505530|Secondary|Change in Physical Performance Measures Using the Time Up and Go (TUG) Test|Time Up and Go (TUG) is a timed walking test designed to measure gait performance and balance. It measures in seconds the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm [18in], arm height 65 cm [25.6 in]), walk a distance of 3 meters (118 inches, approximately 10 feet), turn, walk back to the chair, and sit down.|Baseline, Cycles 2, 4, 6, 8 and 10; Day 1|All participants that received at least one dose of study drug and had evaluable post-baseline measurements.|||seconds||Standard Deviation|Mean
2668542|NCT01505530|Secondary|Change in Physical Performance Measures Using Hand Grip Strength|Hand grip strength (HGS) of the non-dominant hand measured using a hand dynamometer.|Baseline, Cycles 2, 4, 6, 8 and 10; Day 1|All participants that received at least one dose of study drug and had evaluable post-baseline measurements.|||kilogram (kg)||Standard Deviation|Mean
2668543|NCT01505530|Secondary|Change in Lean Body Mass|Change in lean body mass was assessed using dual-energy x-ray absorptiometry (DXA).|Baseline, Cycles 3, 5, 7, 9 and 11; Day 1|All participants that received at least one dose of study drug and had evaluable post-baseline measurements.|||grams (g)||Standard Deviation|Mean
2668544|NCT01505530|Secondary|Duration of Response|The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR) was defined as having at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.|First CR or PR to Disease Progression (Up to 11 months)|All randomized participants.|||months||90% Confidence Interval|Median
2668545|NCT01505530|Secondary|Percentage of Participants With Tumor Response Rate (RR)|Response rate (RR) was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria.|Baseline to Disease Progression (Up to 11 months)|All randomized participants.|||percentage of participants|||Number
2668546|NCT01505530|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from date of first dose to the first observation of disease progression or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.|Baseline to Disease Progression or Death from Any Cause (Up to 16 months)|All randomized participants.|||months||90% Confidence Interval|Median
2668547|NCT01505530|Primary|Overall Survival (OS)|Overall survival (OS) duration was measured from the date of randomization to the date of death from any cause.|Baseline to Death from Any Cause (Up to 23 months)|All randomized participants. Participants who were alive at data cut-off for the OS analysis or lost to follow-up were censored on the last date the participant was known to be alive. Censored participants; 300 mg LY2495655 = 9,100 mg LY2495655 =13, Placebo= 16.|||months||90% Confidence Interval|Median
2668548|NCT01505491|Secondary|Apparent Clearance of the BI 695501 in the Plasma After Extra-vascular Administration (CL/F)|Apparent clearance of the BI 695501 in the plasma after extra-vascular administration (CL/F).|1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration|Pharmacokinetic set (PKS): This set included all subjects of the randomized and treated set who in addition provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of bio-equivalence.|||Milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
2668549|NCT01505491|Secondary|Terminal Half- Life of the BI 695501 in Plasma (t1/2)|Terminal half- life of the BI 695501 in plasma (t1/2).|1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration|Pharmacokinetic set (PKS): This set included all subjects of the randomized and treated set who in addition provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of bio-equivalence.|||hour||Geometric Coefficient of Variation|Geometric Mean
2668550|NCT01505491|Primary|Maximum Measured Concentration of the BI 695501 in Plasma (Cmax)|Maximum measured concentration of the BI 695501 in plasma (Cmax). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic.|1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration|Pharmacokinetic set (PKS): This set included all subjects of the randomized and treated set who in addition provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of bio-equivalence.|||Micro-gram/milliliter (μg/mL)||Geometric Coefficient of Variation|Geometric Mean
2668551|NCT01505491|Primary|Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 to the Time of the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic.|1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration|Pharmacokinetic set (PKS): This set included all subjects of the randomized and treated set who in addition provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of bio-equivalence.|||Micro-gram*hour/milliliter (μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2668552|NCT01505491|Primary|Area Under the Concentration-time Curve of the BI 695501 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)|Area under the concentration-time curve of the BI 695501 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Geometric mean and geometric coefficient of variation (gCV) are provided as descriptive statistic.|1 hour (h) before drug administration and 1, 4, 8, 12, 24, 48, 60, 72, 84, 96, 108, 120, 132, 144, 168, 192, 240, 312, 480, 648, 816, 1032, 1320, 1704 h after drug administration|Pharmacokinetic set (PKS): This set included all subjects of the randomized and treated set who in addition provided at least one Pharmacokinetic (PK) endpoint and had no important protocol violations relevant to the evaluation of bio-equivalence.|||Micro-gram*hour/milliliter (μg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2668553|NCT01505465|Secondary|Melatonin Effects on Patient Controlled Analgesia and Postoperative Narcotic Usage|A 25% in narcotic usage will be considered clinically important|Up to 3 days|DATA NOT COLLECTED||||||
2668554|NCT01505465|Secondary|Melatonin Effects on Daytime Activity|A 20% difference will be considered clinically important.|Up to postoperative day 3|DATA NOT COLLECTED||||||
2668555|NCT01505465|Secondary|Melatonin Effects on Delirium During Post-operative Inpatient Stay Based on Clinical Assessment in Patients 65 and Older|A difference of 25% will be considered clinically important.|Up to postoperative day 3|DATA NOT COLLECTED||||||
2668556|NCT01505465|Secondary|Perioperative Effects of Melatonin on Post-operative Pain Scores|A difference in 25% in average pain score at each time point be considered clinically significant.|Up to postoperative day 3|DATA NOT COLLECTED||||||
2668557|NCT01505465|Primary|Perioperative Sleep Efficiency|Sleep time change from 96 hours before surgery to 72 hours after surgery|96 hours before surgery to 72 hours after surgery||||minutes||Inter-Quartile Range|Mean
2668558|NCT01505387|Secondary|Blood Pressure|Measured in mm Hg|24 weeks|||||||
2668559|NCT01505387|Secondary|Full Blood Count|Erythrocytes, leukocytes, thrombocytes, haematocrit, haemoglobin, Mean corpuscular volume (MCV), Mean corpuscular haemaglobin (MCH)|24 weeks|||||||
2668560|NCT01505387|Secondary|Body Mass Index (kg/m^2)|Changes from baseline to end of study|24 weeks|||||||
2668561|NCT01505387|Secondary|Waist and Hip Circumference (cm)|Changes from baseline to end of study|24 weeks|||||||
2668562|NCT01505387|Primary|Mean Change in Body Weight From Baseline to End of 24 Weeks|Change in body weight at the end of 24 weeks measured in kg using a calibrated scale. (positive values signify weight gain, while negative values signify weight reduction|24 weeks||||kg||Standard Deviation|Mean
2668563|NCT01505374|Secondary|Postoperative Complications||Up to postoperative day 2|Analysis of postoperative complications was not performed because sufficient data could not be collected regarding the secondary outcome||||||
2668564|NCT01505374|Secondary|Rating the Success of the Nerve Blocks||Up to postoperative day 2|The success of nerve blocks was not collected or analyzed. Instead, muscle strength was collected (data are presented in another table).||||||
2668565|NCT01505374|Secondary|Duration of Motor and Sensory Blockade||Up to postoperative day 2|The duration of motor and sensory blockade was not calculated and analyzed, because accurate data regarding block resolution time could not be acquired from patients.||||||
2668566|NCT01505374|Secondary|Patient Satisfaction With Nerve Blocks|Rated on a 0-10 scale, with a higher score representing greater satisfaction.|Up to postoperative day 1||||units on a scale||Standard Deviation|Mean
2668567|NCT01505374|Secondary|Preoperative and Postoperative Thigh Muscle Strength in Both Legs|This was measured with a dynamometer to gauge strength.|Up to postoperative day 2||||kilogram-force unit||Standard Deviation|Mean
2668568|NCT01505374|Secondary|Tracking Total Opioid Usage||Up to postoperative day 2||||milligrams||Standard Deviation|Mean
2668569|NCT01505374|Primary|Visual Analogue Scale Pain Score|The primary outcome is the postoperative pain in each leg within the first 24 hours postoperatively. VAS pain scores could range from 0 to 10. Higher values represent a worse outcome.|Up to postoperative day 1||||units on a scale||Standard Deviation|Mean
2668570|NCT01505179|Secondary|Change in Doppler Echocardiographic Parameters, Septal E/e' Ratio (E/e')|Doppler echo allows non-invasive evaluation of diastolic cardiac function. The mitral inflow velocity (E) correlates with LV filling pressure, but is influenced by myocardial relaxation time (RT) and filling pressure. The early diastolic septal mitral annular tissue velocity (e') varies with RT alone. The unitless ratio of the E to e' velocities (E/e') is considered a reliable surrogate of LV filling pressure. Prediction of normal diastolic filling pressure is most reliable when E/e' is < 8; and of abnormal filling pressure when E/e' is > 15. The percent change is reported.|6 weeks|Entire Study Population|||percent change||Standard Deviation|Mean
2668597|NCT01504867|Secondary|Mean Hospital Length of Stay||approximately 7 days|Intention-to-Treat|||days||Standard Deviation|Mean
2668598|NCT01504867|Secondary|Number of Subjects Admitted to Intensive Care Unit (ICU)||7 days|Intention-to-Treat|||participants|||Number
2668571|NCT01505179|Secondary|Change in Quality of Life (QOL) Score|The Minnesota Living with Heart Failure (HF) Questionnaire was re-administered at the 6 week time point. The total quality of life (QOL) scores were compared to the baseline score. The well-validated Minnesota Living with Heart Failure questionnaire is self-administered, has 21 questions and takes 5-10 minutes to complete. The test measures perceived health-related QOL. Each question is scored from 0 to 5 on the Likert scale, where 0 is 'none', and 5 is 'very much'. QOL scores range from 0 to 105; a lower score represents a better quality of life. After an intervention, a decrease in score reflects an improvement in QOL. A minimally important difference in the total score is 5 points.|6 weeks|The analysis population is comprised of the 10 patients who were eligible and consented for participation in the trial. Six patients were assigned to the Ranolazine group and four to the placebo group, randomization was by chance.|||units on a scale||Standard Deviation|Mean
2668572|NCT01505179|Primary|Change in Oxygen Consumption (VO2) at 6 Weeks|Oxygen consumption (VO2) as described at baseline is remeasured after 6 weeks of drug vs placebo.|6 weeks|Entire study population|||ml/kg/min||Standard Deviation|Mean
2668573|NCT01505179|Primary|Change in Exercise Capacity at 6 Weeks|Exercise capacity in terms of exercise duration (time in seconds) as described for the baseline value, is repeated at 6 weeks.|6 weeks|Entire study population|||seconds||Standard Deviation|Mean
2668574|NCT01505166|Other Pre-specified|Number of Alive Subjects (Part 1)|For Part 1, this was to determine the overall survival rate in patients with CLM following resection +/= ablation with curative intent treated with adjuvant chemotherapy and Vigil™ by following these patients up to 24 months.|24 Months|3 subjects were enrolled in Part 1 and completed Vigil plus chemotherapy. After 24 months, 2 subjects were still alive and 1 subject was dead. Statistical analysis was not done. This study was terminated.|||Participants|||Count of Participants
2668575|NCT01505166|Other Pre-specified|Enzyme-Linked ImmunoSorbent Spot (ELISPOT) (Part 1)|To determine if subjects will have a positive (defined as >10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until 30 days after last dose.|Baseline, End of Treatment (30 days after last dose) up to 12 months|3 subjects were enrolled in Part 1 and completed Vigil plus chemotherapy. After 12 months, all 3 subjects had positive ELISPOT response. Statistical analysis was not done. This study was terminated.|||Participants|||Count of Participants
2668576|NCT01505166|Primary|Percent of Patients Who Survived After Treatment (Part 2)|To determine and compare the overall survival rate in patients with CLM following resection +/- ablation with curative intent treated with sandwich or adjuvant chemotherapy and Vigil™ vaccine versus sandwich or adjuvant chemotherapy and placebo and compare with historical data.|24 months|This outcome measure was for Part 2. No subjects were randomized in Part 2. This study was terminated.||||||
2668577|NCT01505166|Primary|Percent of Patients Who Progressed After Treatment (Part 2)|Response rate will also be evaluated in this study using the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST) (unidimensional measurement) of the tumor lesions are used in the RECIST criteria.The response in patients with measurable disease will be reported using standard outcome measures for clinical trials: complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). Any response to treatment (either PR or CR) requires two confirmatory staging at least 4 weeks apart. Patients will be evaluable for tumor response if measurable disease is present.|24 months|This outcome measure was for Part 2. No subjects were randomized in Part 2. This study was terminated.||||||
2668578|NCT01505166|Primary|Immune Analysis in Tumor Biopsy and Blood (Part 1)|To evaluate and correlate Tumor Infiltrating Lymphocytes (TIL) in initial excised tumor and Enzyme-Linked ImmunoSorbent Spot (ELISPOT) responses to Vigil™ vaccine in blood of patients with CLM.|Up to 12 months|3 subjects were enrolled in Part 1 and completed Vigil plus chemotherapy. However, TIL was not tested/collected so no correlation could be performed. Statistical analysis was not done. This study was terminated.||||||
2668579|NCT01505114|Primary|Occurrence of Grade 3 or Higher Adverse Events (AEs)|participants had Occurrence of Grade 3 or higher adverse events (AEs)|Through Week 48||||Participants|||Count of Participants
2668580|NCT01505062|Primary|Percentage of Participants With TEAEs by Severity|An AE was any unfavorable and unintended physical sign, symptom, or laboratory parameter that developed or worsened in severity during the course of the study, whether or not considered related to the IMP. The TEAEs were defined as any event that started or increased in severity after the participant received IMP, including abnormal laboratory results, electrocardiogram, etc. For each AE, the severity was categorized as either mild, moderate or severe where 'mild' was defined as discomfort noticed but did not interfere with the participant's daily routines (an annoyance), 'moderate' was defined as some impairment of function, not hazardous to health (uncomfortable or embarrassing), and 'severe' was defined as significant impairment of function, hazardous to health (incapacitating).|From Baseline to Week 48|Analysis was performed on safety population.|||percentage of participants|||Number
2668581|NCT01505062|Primary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) was any unfavorable and unintended physical sign, symptom, or laboratory parameter that developed or worsened in severity during the course of the study, whether or not considered related to the IMP. The TEAEs were defined as any event that started or increased in severity after the participant received IMP, including abnormal laboratory results, electrocardiogram, etc.|From Baseline to Week 48|Analysis was performed on safety population.|||percentage of participants|||Number
2668582|NCT01505010|Secondary|The Intensity of Medical Treatment|The number and doses of blood-pressure lowering drugs in the 2 arms of the trial.|This endpoint will be assessed 6 months after randomization.||||number of drugs taken per day||Inter-Quartile Range|Median
2668583|NCT01505010|Primary|Change in Glomerular Filtration Rate|The primary endpoint for safety of renal denervation is the baseline-adjusted between group difference in the change of glomerular filtration rate estimated by using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation.|This endpoint has been assessed 6 months after randomization.||||ml/min/1.73 m2||Standard Deviation|Mean
2668584|NCT01505010|Primary|Change in Systolic Blood Pressure From Baseline to 6 Months on 24-h Ambulatory Measurement (Follow-up Minus Baseline Measurement)|The primary endpoint deals with efficacy of renal denervation with regard to controlling blood pressure on ambulatory measurement. It consists of the baseline-adjusted between-group difference in the changes in 24-h systolic blood pressure. Because automated blood pressure monitors will be used, the assessment of the primary endpoint is blind.|The primary endpoint has been assessed 6 months after randomization.||||mmHg||95% Confidence Interval|Mean
2668605|NCT01504854|Secondary|Change in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)|The ADCS-ADL is an activities of daily living inventory developed by the ADCS to assess functional performance in participants with AD. The ADCS-ADL includes some items from traditional basic ADL tests (e.g., grooming, dressing, walking, bathing, feeding, toileting) as well as instrumental (complex) activities of daily living (e.g., shopping, preparing meals, using household appliances, keeping appointments, reading). This structured questionnaire is administered to the subject's caregiver/study partner. The range of this instrument is 0 to 78 with lower numbers indicating greater impairment.|Week 52||||units on a scale||Standard Deviation|Mean
2668606|NCT01504854|Primary|Change From Baseline in Volumetric Magnetic Resonance Imaging (MRI)|MRI will be used to assess the effect of treatment on rate of whole brain volume|Baseline and Week 52|ITT population|||cm^3||Standard Deviation|Mean
2668607|NCT01504854|Primary|Number of Adverse Events|The safety and tolerability of treatment with resveratrol will be assessed by analysis of adverse events, including symptoms, abnormal findings on physical examinations, standard laboratory tests and PK analysis of resveratrol and its major metabolites. The frequencies of adverse events or laboratory abnormalities between the participants who receive resveratrol and those receiving placebo will be compared.|Baseline, Weeks 6, 13, 19, 26, 32, 39, 45, and 52|ITT population|||number of AEs|||Number
2668608|NCT01504854|Post-Hoc|Change From Baseline in Cerebrospinal Fluid Amyloid β40 Concentration at 52 Weeks|Mean change from baseline in cerebrospinal fluid amyloid β40 concentration at 52 weeks|Baseline and Week 52|Post-hoc modified intention-to-treat (ITT) re-analysis of primary outcomes at Week 52 adjusting for age and AD duration in the mixed-model repeated measures model|||ng/ml||Standard Deviation|Mean
2668609|NCT01504841|Secondary|Decline in Absolute CD4 Percent of Greater Than 5 Percent Any Time After 12 Weeks of Therapy|Number (%) of participants with a >5% decline in absolute CD4 percent from baseline at weeks 12, 24, and 48, by Cohort, including Clopper-Pearson confidence intervals.|Measured at baseline and at Weeks 12, 24, and 48|Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.|||Participants|||Count of Participants
2668610|NCT01504841|Secondary|New Onset Opportunistic Infection (OI) or AIDS Diagnosis|Number (%) of participants with a new onset opportunistic infection (OI) or AIDS diagnosis, by Cohort.|From baseline to occurrence of event, up to Week 48.|Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.|||Participants|||Count of Participants
2668611|NCT01504841|Secondary|Change in Optimized Background Regimen Due to Virologic Failure|Number (%) of participants who initiated a change in their optimized background regimen (OBR) due to virologic failure, by Cohort.|Measured at entry and at Weeks 8, 12, 24, and 48|Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.|||Participants|||Count of Participants
2668612|NCT01504841|Secondary|Treatment Discontinued Due to Toxicity or Virologic Failure|Number (%) of participants who discontinued study treatment (ETR) due to a toxicity or Virologic Failure (VF), by Cohort.|From baseline to occurrence of event, up to Week 48.|Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.|||Participants|||Count of Participants
2668613|NCT01504841|Secondary|HIV-1 RNA Virologic Failure Status at Weeks 24 and 48|Number (%) of participants with confirmed Virologic Failure, defined as: failure to suppress plasma HIV-1 RNA to fewer than 400 copies/ml and failure to achieve at least a 2-log10 reduction (from baseline) in HIV-1 RNA at Weeks 24 or 48, by Cohort, with Clopper-Pearson confidence intervals. The initial HIV-1 RNA results that met the Virologic Failure definition were each confirmed by a second result obtained within 1 to 4 weeks of the initial result obtained at Week 24 and/or 48.|Baseline, Week 24, and Week 48|Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.|||Participants|||Count of Participants
2668614|NCT01504841|Secondary|AEs of Grade 3 or Higher Severity Judged to be at Least Possibly Attributable to the Study Medications|Number (%) of Participants with AEs of Grade 3 or higher severity judged, by the Study Team, to be at least possibly attributable to the study medications by Cohort, including Clopper-Pearson confidence intervals.|From baseline to occurrence of event, up to Week 48.|Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.|||Participants|||Count of Participants
2668615|NCT01504841|Primary|Area Under the Plasma Concentration-Time Curve Over 12 Hours of ETR|Geometric Mean (Standard Deviation) of the area under the plasma concentration-time curve over 12 hours (AUC12h) of ETR.|Pre-dose, 1, 2, 4, 6, 9, and 12 hours post-dose measured at intensive PK visit (within 7-10 days after last dose of study drug administration)|Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure. They must also be considered PK evaluable by the study team; 1 Participant in Cohort 1 is not.|||ng*h/mL||Standard Deviation|Geometric Mean
2668616|NCT01504841|Primary|Death|Number (%) of deaths on study by Cohort.|From baseline to occurrence of event, up to Week 48.|Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.|||Participants|||Count of Participants
2668617|NCT01504841|Primary|Adverse Events (AEs) of Grade 3 or Higher Severity|Number (%) of participants who experienced a Grade 3 or higher severity adverse event through Week 48 by Cohort, with Clopper-Pearson confidence intervals.|From baseline to occurrence of event, up to Week 48.|Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.|||Participants|||Count of Participants
2668618|NCT01504841|Primary|Termination From Treatment Due to a Suspected Adverse Drug Reaction (SADR)|Number (%) of participants who discontinued treatment due to a suspected adverse drug reaction (SADR) by Cohort.|From baseline to occurrence of event, up to Week 48.|Analysis population is defined as having been treated exclusively on the final dose determined to be optimal for a given cohort without adjustments and having either completed 48 weeks of exposure to the study drug or been classified as a safety failure, due to a study drug related adverse event occurring during the first 48 weeks of treatment.|||Participants|||Count of Participants
2668619|NCT01504477|Primary|Maximum Tolerated Dose|The maximum tolerated dose of panitumumab (to be used in combination with bortezomib)|12 months|The maximum tolerated dose of panitumumab (to be used in combination with bortezomib)|||mg/kg|||Number
2668620|NCT01504477|Secondary|Duration of Disease Control|Time from study registration until progressive disease|2 years||||Days||95% Confidence Interval|Median
2668621|NCT01504477|Secondary|Percent of of Patients With a Complete or Partial Response|Partial response plus complete response as per RECIST v1.0|16 weeks||||Participants|||Count of Participants
2668622|NCT01504477|Secondary|Percent of Patients With Disease Control|Stable disease after 2 cycles, partial response or complete response as determined by RECIST v1.0|16 weeks||||percentage of participants|||Number
2668623|NCT01504477|Primary|Maximum Tolerated Dose|The maximum tolerated dose of bortezomib (to be used in combination with panitumumab)|12 months|The maximally tolerated dose of bortezomib weekly to be used in combination with with Panitumumab every 2 weeks|||mg/m2|||Number
2668624|NCT01504412|Secondary|Mean Change in Short Form-McGill Pain Questionnaire From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy|"The Short Form-McGill Pain Questionnaire (SF-MPQ) Visual Analog Scale (VAS) is reported. For VAS, participants rated pain intensity on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain.~Greater mean changes (improvements) in SF-MPQ indicated better outcomes."|at Week 7 postdose|Mean change in SF-MPQ VAS was assessed in the Full Analysis Set.|||units on a scale||Standard Error|Mean
2668625|NCT01504412|Primary|Mean Change in Average Daily Pain Score From Baseline Among Participants Who Received DS5565 for Pain Associated With Diabetic Peripheral Neuropathy|The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 [no pain] to 10 [worst possible pain]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries. Greater mean changes (improvements) in ADPS indicated better outcomes. A minimally meaningful effect was a mean decrease of at least 1.0 point [scale of 0 to 10] versus placebo.|Baseline to Week 7 postdose|Mean change in ADPS was assessed in the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
2668626|NCT01504204|Secondary|Change in Acne Lesion Count|Change in total count of acne lesions from baseline visit to Week 6 visit|Baseline and 6 weeks||||lesions||Full Range|Mean
2668627|NCT01504204|Secondary|Change in Acne Global Assessment|Change in the physician's global assessment of acne severity on a validated 0-5 scale (0=clear to 5=very severe) from baseline to Week 6 visit.|Baseline and 6 weeks||||Participants|||Count of Participants
2668628|NCT01504204|Primary|Adherence to Study Medication|Adherence will be reported as percentage of prescribed doses taken as measured electronically by a Medication Event Monitoring System (MEMS®) cap.|Baseline to 6 weeks|the median and ranges of subject ages for the sample and no sample group were 19 years, primarily female identifying as Caucasian.|||percentage of doses||Standard Deviation|Median
2668629|NCT01503749|Secondary|Mean Change in Child-Pugh Score and Model For End-Stage Liver Disease (MELD) Score|The efficacy (mean change in Child-Pugh score and Model For End-Stage Liver Disease score [at weeks 24]) of ultrasound-guided percutaneous portal transplantation of peripheral blood monocyte cell in cirrhotic patients. MELD Score = (0.957 * ln(Serum Cr) + 0.378 * ln(Serum Bilirubin) + 1.120 * ln(INR) + 0.643 ) * 10 (if hemodialysis, value for Creatinine is automatically set to 4.0) (minimum <9: 1.9% mortality; maximum 40 or more: 71.3% mortality). Child-Pugh score = Bilirubin (mg/dl): <2 (1 point),2-3 (2 points), >3 (3 points) + Albumin (g/dl): >3.5 (1 point),3.5-2.8 (2 points), <2.8 (3 points) + PT prolongation (INR): <4 seconds (<1.7) (1 point), 4-6 seconds (1.7-2.3) (2 points),>6 seconds (>2.3) (3 points) + Ascites: Absent (1 point), Slight (2 points), Moderate (3 points) + Encephalopathy: Absent (1 point), Mild (I-II) (2 points), Severe (III-IV) (3 points) ; Class A: 5-6, Class B: 7-9, Class C: 10-15 (minimum 5, maximum 15; higher Child-Pugh score with worse prognosis)|Baseline and Week 24|A total of 9 decompensated cirrhotic patients (5 men and 4 females, age range 45–71 years) grouped by randomization.|||score||Standard Deviation|Mean
2668630|NCT01503749|Primary|Number of Participants With Severe Adverse Events|No serious adverse event. Minor adverse events (not considered to be related to this study), as follows; Control: 6 events (ascites and pleural tapping, gum bleeding, ascties tapping x3, diarrhea) G-colony stimulating factor group: 6 events (percutaneous vertebroplasty, abdominal pain and nausea, hyperkalemia, ascties tapping, diarrhea, liver transplantation) Infusion of the mobilized peripheral blood mononucleated cells group: 1 event (hepatic encephalopathy)|up to 6 months|Nine patients who fulfilled the inclusion and exclusion criteria.|||participants|||Number
2668631|NCT01503333|Other Pre-specified|Motivation for Physical Activity|To assess feelings regarding physical activity, a 10-item scale was used. Response choices ranged from (0) not true to (4) very true. Higher score means better outcome.|baseline to post-intervention||||score on a scale||Standard Deviation|Mean
2668632|NCT01503333|Other Pre-specified|Enjoyment of Physical Activity|To assess feelings or fun regarding physical activity, a 6-item Physical Activity Enjoyment Scale was used. Response choices ranged form (0) not at all true to (3) very true. Higher score means better outcome.|baseline to post-intervention||||score on a scale||Standard Deviation|Mean
2669727|NCT01493089|Secondary|Percentage of Patients Responding in 90 Minutes|Proportion of patients who have achieved sustained response, sustained partial response or sustained total relief by 90 minutes|14 days|mITT|||Percentage of patients||95% Confidence Interval|Number
2668634|NCT01503333|Other Pre-specified|Physical Activity Self-Efficacy|To measure girls' confidence in their ability to attain physical activity during their free time when facing barriers or not, a 6-item Physical Activity Self-Efficacy scale was used. Response choices ranged from (0) disagree a lot to (3) agree a lot. Higher score means better outcome.|baseline to post-intervention||||score on a scale||Standard Deviation|Mean
2668635|NCT01503333|Other Pre-specified|Perceived Barriers to Physical Activity|To assess obstacles interfering with physical activity, girls completed a 16-item Perceived Barriers Scale. Response choices ranged from (0) not at all true to (3) very true. Higher score means worse outcome.|Baseline to post-intervention||||score on a scale||Standard Deviation|Mean
2668636|NCT01503333|Other Pre-specified|Perceived Benefits of Physical Activity|To assess positive consequences of physical activity, girls completed 10-item Perceived Benefits Scale. Response choices ranged form (0) not at all true to (3) very true. Higher score means better outcome.|baseline to post-intervention||||score on a scale||Standard Deviation|Mean
2668637|NCT01503333|Other Pre-specified|Minutes of Moderate-to-Vigorous Physical Activity 9-month Follow up|Minutes of MVPA were measured via ActiGraph GT3X+ accelerometers worn on an elastic belt at the right hip for 7 consecutive days, including 5 weekdays and 2 weekend days at 9-month follow up. Monitors were set to start collecting and storing data in raw format beginning 5:00 A.M. on the day after they were distributed to girls each school. Data were re-integrated to 15-second epochs and processed using established intensity cut-points. One week after distribution, data collectors returned to each school to collect the accelerometers. An imputation approach based on all available data in hour blocks on all 7 days was implemented. Wear time was standardized to 14 hours/weekday (one hour before each school's actual start time; 7 hours during school; 6 hours after school) and 10 hours/weekend day (later awake time from 11 a.m. to 9 p.m.).|9 months after the end of the 17-week intervention||||mean minutes per hour||Standard Deviation|Mean
2668638|NCT01503333|Secondary|Percent Body Fat|Percent body fat estimated via a foot-to-foot body weight scale with bioelectrical impedance analysis capabilities.|Percent body fat at post-intervention (immediately after 17-week intervention)||||percent body fat||Standard Error|Mean
2668639|NCT01503333|Secondary|Body Mass Index (BMI) Z-score|"To obtain BMI-z score, height and weight were assessed. Height was measured to nearest 0.1 cm using portable stadiometer.~Weight was assessed to nearest 0.1 kg with foot-to-foot bioelectric impedance analysis scale. BMI was calculated and then converted into a percentile using age- and sex-specific reference values from the Centers for Disease Control and Prevention growth charts to determine BMI-z score."|Body mass index z-score at post-intervention (after 17-week intervention)||||z-score||Standard Error|Mean
2668640|NCT01503333|Secondary|Cardiovascular Fitness (Aerobic Performance)|Between group comparison measured by number of laps run in a progressive shuttle run test. CV fitness was assessed via estimation of maximal oxygen consumption.|Cardiovascular fitness after 17-week intervention (post-intervention)||||ml/kg/min||Standard Deviation|Mean
2668641|NCT01503333|Primary|Minutes of Moderate to Vigorous Physical Activity (MVPA) Post-intervention|Minutes of MVPA were measured via ActiGraph GT3X+ accelerometers worn on an elastic belt at the right hip for 7 consecutive days, including 5 weekdays and 2 weekend days at post-intervention. Monitors were set to start collecting and storing data in raw format beginning 5:00 A.M. on the day after they were distributed to girls each school. Data were re-integrated to 15-second epochs and processed using established intensity cut-points. One week after distribution, data collectors returned to each school to collect the accelerometers. The majority (1386 [post-intervention] of 1519 girls [baseline], 91.24%) provided at least 8 hours of data on 3 weekdays and 1 weekend day. An imputation approach based on all available data in hour blocks on all 7 days was implemented. Wear time was standardized to 14 hours/weekday (one hour before each school's actual start time; 7 hours during school; 6 hours after school) and 10 hours/weekend day (later awake time from 11 a.m. to 9 p.m.).|Minutes of moderate to vigorous physical activity per hour at post-intervention (after 17-week intervention)|The majority (1386 [post-intervention] of 1519 girls [baseline], 91.24%) provided at least 8 hours of data on 3 weekdays and 1 weekend day.|||mean minutes per hour||Standard Deviation|Mean
2668642|NCT01503164|Secondary|Area Under the Curve Assessed by Oral Glucose Tolerance Test (OGTT)|Results of the oral glucose tolerance test will be analyzed using indices derived from the serial glucose and insulin levels over a 2 hour period 2 months post intervention. This will be the area under the glucose/ insulin curves|2 month after intervention|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||mg/dL per 120 min||Standard Deviation|Mean
2668643|NCT01503164|Secondary|Area Under the Curve Assessed by Oral Glucose Tolerance Test|Results of the oral glucose tolerance test will be analyzed using indices derived from the serial glucose and insulin levels over the 2 hour period. This will be the area under the glucose/ insulin curves|Baseline|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||mg/dL per 120 min||Standard Deviation|Mean
2668644|NCT01503164|Secondary|Endothelial Function|Endothelial function will be assessed using peripheral arterial tonometry using the Endo-PAT device. Using the EndoPat device, the relative vasoconstriction of occluded versus non-occluded arms was derived and provided the relative hyperemic index.|2 month after intervention|Data was not collected for all participants for this outcome measure. Participants for whom data was available are included in analysis.|||ratio||Standard Deviation|Mean
2668645|NCT01503164|Secondary|Endothelial Function|Endothelial function will be assessed using peripheral arterial tonometry using the Endo-PAT device. Using the EndoPat device, the relative vasoconstriction of occluded versus non-occluded arms was derived and provided the relative hyperemic index.|Baseline|Data was unable to be collected for all participants in this outcome measure.|||ratio of occluded versus non-occluded||Standard Deviation|Mean
2668646|NCT01503164|Secondary|Acute Insulin Response to Glucose (AIRG)|The acute insulin response to glucose (AIRG) value is derived from the MINMOD analysis of the glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test. A low AIRG indicates decreased ability of the pancreas to secrete insulin.|2 months after intervention|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||[mU/L-min]||Standard Deviation|Mean
2668647|NCT01503164|Secondary|Acute Insulin Response to Glucose (AIRG)|The acute insulin response to glucose (AIRG) value is derived from the MINMOD analysis of the glucose and insulin levels obtained during the frequently sampled intravenous glucose tolerance test. A low AIRG indicates decreased ability of the pancreas to secrete insulin.|Baseline|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||[mU/L-min]||Standard Deviation|Mean
2668648|NCT01503164|Secondary|Disposition Index (DI)|The disposition index is the mathematical product of insulin sensitivity (SI) and acute insulin response to glucose (AIRG) both of which are derived from the MINMOD analysis of the frequently sampled intravenous glucose tolerance test data.|2 months after intervention|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||[mU/L]^-1 x [min]^-1] x [mU/L-min]||Standard Deviation|Mean
2668649|NCT01503164|Secondary|Disposition Index (DI)|The disposition index is the mathematical product of insulin sensitivity (SI) and acute insulin response to glucose (AIRG) both of which are derived from the MINMOD analysis of the frequently sampled intravenous glucose tolerance test data. A low DI is indicative of a higher risk of developing diabetes.|Baseline|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||[mU/L]^-1 x [min]^-1] x [mU/L-min]||Standard Deviation|Mean
2668650|NCT01503164|Secondary|Glucose Effectiveness (SG)|Glucose effectiveness is the ability for glucose to move intracellularly in the absence of insulin. It is a parameter that results from the MINMOD analysis of the serum glucose and insulin levels derived from the frequently sampled intravenous glucose tolerance test. Low SG indicates a lower predisposition for glucose disposal independent of any effects of insulin.|2 months after intervention|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||[min]^-1||Standard Deviation|Mean
2668651|NCT01503164|Secondary|Glucose Effectiveness (SG)|Glucose effectiveness is the ability for glucose to move intracellularly in the absence of insulin. It is a parameter that results from the MINMOD analysis of the serum glucose and insulin levels derived from the frequently sampled intravenous glucose tolerance test. Low SG indicates a lower predisposition for glucose disposal independent of any effects of insulin.|Baseline|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||[min]^-1||Standard Deviation|Mean
2668652|NCT01503164|Primary|Insulin Sensitivity (SI)|"Insulin sensitivity will be determined with the insulin-modified frequently sampled intravenous glucose tolerance test (IVGTT) before and 2-months after study intervention. This test requires administration of a weight-adjusted dose of D50W as an IV bolus at time zero. After the glucose bolus, blood samples are drawn at the scheduled times for 3-hours. At the 20-minute mark, a weight-adjusted dose of regular insulin is administered. The resulting serum is analyzed for glucose and insulin and the minimal model (MINMOD) will be used to derive insulin sensitivity. A low SI signifies low insulin sensitivity and high SI represents high insulin sensitivity."|2 months after intervention|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||[mU/L]^-1 x [min]^-1||Standard Deviation|Mean
2668653|NCT01503164|Primary|Insulin Sensitivity (SI)|"Insulin sensitivity will be determined with the insulin-modified frequently sampled intravenous glucose tolerance test (IVGTT) before and 2-months after study intervention. This test requires administration of a weight-adjusted dose of D50W as an IV bolus at time zero. After the glucose bolus, blood samples are drawn at the scheduled times for 3-hours. At the 20-minute mark, a weight-adjusted dose of regular insulin is administered. The resulting serum is analyzed for glucose and insulin and the minimal model (MINMOD) will be used to derive insulin sensitivity. A low SI signifies low insulin sensitivity and high SI represents high insulin sensitivity."|Baseline|55 randomized to PAP (2 dropout); 56 randomized to lifestyle (1 dropout)|||[mU/L]^-1 x [min]^-1||Standard Deviation|Mean
2668654|NCT01503021|Other Pre-specified|Incidence of Patients Meeting Hy's Law Criteria|The peak alanine aminotransferase and the peak total bilirubin levels were evaluated per patient. Laboratory values for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Patients with alanine aminotransferase more than three times the upper limit of normal and also total bilirubin more than two times the upper limit of normal are counted.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||participants|||Number
2668655|NCT01503021|Other Pre-specified|Transferrin Saturation|The baseline and end of treatment predialysis transferrin saturation were evaluated for the 52-week extension study to confirm clearance of iron derived from soluble ferric pyrophosphate.|Baseline, up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percent transferrin saturation||Standard Deviation|Mean
2668656|NCT01503021|Other Pre-specified|Serum Iron|The baseline and end of treatment predialysis serum iron levels were evaluated for the 52-week extension study to determine the effect of soluble ferric pyrophosphate on serum iron.|Baseline, up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||micromoles per liter||Standard Deviation|Mean
2668657|NCT01503021|Other Pre-specified|Ferritin|The baseline and end of treatment predialysis ferritin levels were evaluated for the 52-week extension study to determine whether soluble ferric pyrophosphate increases iron stores.|Baseline, up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||micrograms per liter||Standard Deviation|Mean
2668658|NCT01503021|Other Pre-specified|Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 5|Transferrin saturation (based on TIBC derived from transferrin levels) was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percent transferrin saturation||Standard Deviation|Mean
2668659|NCT01503021|Other Pre-specified|Transferrin Saturation Change From Pre-dialysis to Post-dialysis at Week 2|Transferrin saturation (based on TIBC derived from transferrin levels) was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percent transferrin saturation||Standard Deviation|Mean
2668672|NCT01502956|Secondary|Quality of Life (HUI-3)|Change from baseline in quality of life measures over the first 6 month visit period (6 month assessment) as measured by the Health Utility Index, Version 3 (HUI-3). The HUI 3 scale has a range from 0 to 1 with higher scores representing better health.|6 Months|All eligible participants who provided at least 1 post-baseline diary assessment.|||units on a scale||95% Confidence Interval|Mean
2668660|NCT01503021|Other Pre-specified|Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 5|Unsaturated iron-binding capacity was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||micromoles per liter||Standard Deviation|Mean
2668661|NCT01503021|Other Pre-specified|Unsaturated Iron-binding Capacity Change From Pre-dialysis to Post-dialysis at Week 2|Unsaturated iron-binding capacity was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||micromoles per liter||Standard Deviation|Mean
2668662|NCT01503021|Other Pre-specified|Serum Iron Change From Pre-dialysis to Post-dialysis at Week 5|Serum iron was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 5. Because of the crossover nature of the study, the week 5 values reflect effects of Placebo in the SFP/Placebo arm and effects of SFP in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 5 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||micromoles per liter||Standard Deviation|Mean
2668663|NCT01503021|Other Pre-specified|Serum Iron Change From Pre-dialysis to Post-dialysis at Week 2|Serum iron was assessed from samples obtained pre-dialysis and post-dialysis at a single hemodialysis during study week 2. Because of the crossover nature of the study, the week 2 values reflect effects of SFP in the SFP/Placebo arm and effects of Placebo in the Placebo/SFP arm.|Pre-dialysis and post-dialysis during study week 2 of the Parent (Crossover) Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||micromoles per liter||Standard Deviation|Mean
2668664|NCT01503021|Secondary|Incidence of Serious Adverse Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met seriousness criteria.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percentage of participants|||Number
2668665|NCT01503021|Secondary|Incidence of Systemic/Serious Infections|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse events of systemic/serious infections were defined in the statistical analysis plan for the study to include infections for which the subject was administered at least 3 doses of an IV antibiotic, and infections for which the subject was hospitalized.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percentage of participants|||Number
2668666|NCT01503021|Secondary|Incidence of Other Thrombotic Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for other thrombotic events were pre-specified in the statistical analysis plan for the study.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percentage of participants|||Number
2668667|NCT01503021|Secondary|Incidence of Hemodialysis Vascular Access Thrombotic Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for hemodialysis vascular access thrombotic events were pre-specified in the statistical analysis plan for the study.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percentage of participants|||Number
2668668|NCT01503021|Secondary|Incidence of Composite Cardiovascular Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. Adverse event terms meeting criteria for composite cardiovascular events were pre-specified in the statistical analysis plan for the study.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percentage of participants|||Number
2668669|NCT01503021|Primary|Incidence of Related Suspected Hypersensitivity Reactions|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met protocol criteria for suspected hypersensitivity reactions.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percentage of participants|||Number
2668670|NCT01503021|Primary|Incidence of Treatment-emergent Adverse Events of Intradialytic Hypotension|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention. For each adverse event, investigators assessed whether the event met the protocol criteria for intradialytic hypotension. Intradialytic hypotension events were only to have been reported as adverse events if they exceeded the individual subject's baseline pattern of intradialytic hypotension.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percentage of participants|||Number
2668671|NCT01503021|Primary|Incidence of Treatment-emergent Adverse Events|Adverse events for a given intervention (SFP or Placebo) are counted from the date of the first day of dosing of the intervention until 7 days after the last day of dosing of the intervention.|Up to 7 weeks for the Parent (Crossover) Study and up to 53 weeks for Extension Study|All participants who received at least one dose of study drug (SFP or placebo, as applicable).|||percentage of participants|||Number
2668673|NCT01502956|Secondary|Quality of Life (IIQ-SF)|Change from baseline in quality of life measures over the first 6 month visit period (6 month assessment) as measured by the change in the mean Incontinence Impact Questionnaire short form (IIQ-SF) score. The IIQ-SF scale has a range from 0 to 100 with higher scores indicating a worse quality of life.|6 Months|All eligible participants who provided at least 1 post-baseline diary assessment.|||units on a scale||95% Confidence Interval|Mean
2668674|NCT01502956|Secondary|Quality of Life (UDI-SF)|Change from baseline in quality of life measures over the first 6 month visit period (6 month assessment) as measured by the change in mean Urinary Distress Inventory Short Form (UDI-SF) score. The UDI-SF scale has a range from 0 to 100 with higher scores indicating greater distress.|6 Months|All eligible participants who provided at least 1 post-baseline diary assessment.|||units on a scale||95% Confidence Interval|Mean
2668675|NCT01502956|Secondary|Treatment Satisfaction (OAB-SATq Treatment Preference)|"Treatment preference as measured by the Overactive Bladder Satisfaction of Treatment Questionnaire (OAB-SATq) at 6 months (6 month assessment).OAB-SATq treatment preference is a binary outcome that is classified as yes if a participant answers either Slight preference for the treatment I am receiving now or Definitely prefer the treatment I am receiving now to the question Do you prefer the treatment that you received since entering this study to the treatment you received before the study?"|6 Months|All eligible participants who provided at least 1 postbaseline diary assessment.|||Participants|||Count of Participants
2668676|NCT01502956|Secondary|Treatment Satisfaction (OAB-SATq Treatment Satisfaction, Adverse Effects, Treatment Endorsement, and Convenience)|Treatment satisfaction as measured by the mean Overactive Bladder Satisfaction of Treatment Questionnaire (OAB-SATq) score at 6 months (6 month assessment). The OAB-SATq score ranges from 0 to 100 and includes 5 subscales: treatment satisfaction, side effects, treatment endorsement, convenience, and treatment preference, with higher scores reflecting better satisfaction.|6 months|All eligible participants who provided at least 1 post-baseline diary assessment.|||units on a scale||95% Confidence Interval|Mean
2668677|NCT01502956|Secondary|Severity of Urge Incontinence Symptoms|Severity of urge incontinence symptoms at 6 month visit period as measured by the Sandvik questionnaire. The Sandvik score is a patient-reported measure of incontinence severity as assessed on a scale of slight (1-2), moderate (3-6), severe (8-9), very severe (12) to severe (10-12) using a standard scoring algorithm.|6 Months|All eligible participants who provided at least 1 post-baseline diary assessment.|||Participants|||Count of Participants
2668678|NCT01502956|Secondary|Urinary Frequency and Nocturia|Change in mean number of urinary incontinence episodes (any type) and nocturia episodes from baseline over the first 6-month visit period (1, 2, 3, 4, 5, and 6-month assessments) as measured by the 3 day bladder diary.|6 Months|All eligible participants who provided at least 1 post-baseline diary assessment.|||Number of episodes||95% Confidence Interval|Mean
2668679|NCT01502956|Secondary|Change in Overactive Bladder|Change in mean Overactive Bladder Questionnaire Short Form (OABq-SF) score throughout baseline to the first 6-month visit (1, 2, 3, 4, 5, and 6-month assessments). Values range from 0 to 100 with higher scores on the symptom scale indicating greater severity of symptoms and higher scores on the quality of life scale indicating a better quality of life.|6 Months|All eligible participants who provided at least 1 post-baseline diary assessment.|||units on a scale||95% Confidence Interval|Mean
2668680|NCT01502956|Secondary|Number of Participants With Improvement of Bladder Function and Urinary Leakage|Proportion of subjects who report adequate improvement of their bladder function and urinary leakage with the Patient Global Impression of Improvement Questionnaire (PGI-I) at 6 months. Adequate improvement is defined as a rating of 1, 2, or 3 (better) on the patient-reported measure of perceived improvement with treatment on a scale of 1 (very much better) to 7 (very much worse).|6 Months|All eligible participants who provided at least 1 postbaseline diary assessment.|||Participants|||Count of Participants
2668681|NCT01502956|Primary|Number of Urge Urinary Incontinence (UUI) Episodes|The primary outcome is the change from baseline in mean number of UUI episodes over the first 6-month visit period (1, 2, 3, 4, 5 and 6 month assessments); and is measured using 3-day bladder diaries administered monthly for the first 6 month visit period.|6 Months|All eligible participants who provided at least 1 post-baseline diary assessment.|||UUI episodes||95% Confidence Interval|Mean
2668682|NCT01502787|Secondary|Blood Pressure During Angiotensin II Infusion||12 weeks after initiation of metoprolol||||mmHg||Standard Error|Mean
2668683|NCT01502787|Secondary|Blood Pressure During Exercise||12 weeks||||mmHg||Standard Error|Mean
2668684|NCT01502787|Primary|Forearm Blood Flow||12 weeks after each specified medication||||ml/min||Standard Deviation|Mean
2668685|NCT01502761|Secondary|Number of Participants With Procedure Related Serious Adverse Event|Periprocedural clinical, radiographic and laboratory data will be collected and analyzed to detect Mg related adverse events. Outcome will be assessed perioperatively and at 24 hours, 30 days (+/- 10 days) and 90 days (+/- 15 days)|intraprocedure, postoperative day 1, 1 month, 3 month||||Participants|||Count of Participants
2668686|NCT01502761|Primary|Magnesium Concentration in Region of Cerebral Ischemia|Peripheral Magnesium Levels, meq/L will be obtained through the femoral sheath at the beginning (baseline) and end (post-treatment) of each case. These will be averaged to obtain a femoral Magnesium level. Magnesium levels distal to the occlusion will be measured at the first pass of the clot retrieving device.|Mg level: 1) Peripheral: Baseline and post-treatment (averaged); 2) Distal: after first pass of the clot retriever|Enrollment only occurred in the first arm (lowest dose) of the study as the arms were planned to enroll sequentially. The study was not stopped due to safety concerns|||meq/L||Standard Deviation|Mean
2668687|NCT01502709|Secondary|Number of Participants With Signs and Symptoms of Temporomandibular Disorder Based on Outcomes of Research Diagnostic Criteria (RDC) Exam|RDC for Temporomandibular disorders (TMD) is a reliable & valid system for diagnosis of TMD, utilizing clinical procedures, diagnostic algorithms, and a dual-axis assessment comprising symptom history and physical exam. Signs and symptoms were evaluated by a trained professional and the history was obtained through use of questionnaires. In all sections and scales the higher the number reported corresponds to the more pain being experienced, therefore, a worse outcome. The clinical exam consists of facial, dental, and cervical evaluations including mandibular range of motion, Temporomandibular disorders Joint sound, and palpation of the orofacial muscles and temporomandibular joints (TMJ). Subjects are classified as TMD if they report pain in or around the temporomandibular joints or muscles of mastication for more than 3 months.|Baseline, Month 3||||Participants|||Number
2668688|NCT01502709|Secondary|Mean Percentage of Time Spent in Pain From Days 1-7|The mean of measures taken from days 1-7 was calculated. Composite pain is a measure of mean pain intensity experienced and pain duration. Pain was assessed by using VAS score ranges from 0 millimeter (mm) = no pain to 100 mm = worst possible pain. Duration of pain ranges from 0 to 100% of a day. For example a pain free subject would report O pain intensity for 0% of the day.|Days 1-7||||percentage of day in pain||Standard Deviation|Mean
2668689|NCT01502709|Primary|Change From Baseline in Visual Analog Score (VAS) in Days 1-7 Post Treatment|The mean of measures taken from days 1-7 was calculated. Pain was assessed by using VAS score ranges from 0 millimeter (mm) = no pain to 100 mm = worst possible pain. A decrease in score from Baseline represented treatment response.|Daily Self-reports at Baseline and on Days 1 through 7||||millimeters||Standard Deviation|Mean
2668690|NCT01502644|Primary|Percent Change in Average Daily Pain Score|Participants rated their average lower back pain over the past 24 hours using an 11-point scale (0=no pain to 10=worst possible pain) and recorded it in an electronic diary. The percent change in pain score from baseline is calculated using weekly averages for up to 20 weeks. Linear mixed modeling (LMM) analysis was used to allow for inclusion in the analysis of the majority of participants with any missing data. For the LMM model, group, group × week, average baseline pain, and opioid use at baseline (yes/no) were entered as fixed effects using an autoregressive covariance structure. Participant, intercept, and week were entered as random effects, using a compound symmetry covariance structure. A positive change from baseline indicates an improvement.|Baseline and Week 20|Modified Intent-to-Treat Population, all participants who completed at least 50% of the opioid treatment period (at least 10 weeks of treatment).|||percent change||Standard Deviation|Mean
2668691|NCT01502423|Secondary|Number of Participants With Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.|Adverse events were collected from the time of study drug administration until 70 days following discontinuation of study drug. Serious adverse events were collected from the time that participant signed the informed consent.||||participants|||Number
2668692|NCT01502423|Secondary|Percentage of Participants With no Pruritus in the Draize Scale|Pruritus (itching) was assessed.|10 minutes and 30 minutes after injection||||Percentage of Participants|||Number
2668693|NCT01502423|Secondary|Percentage of Participants With no Edema in the Draize Scale|Edema (swelling) was assessed.|10 minutes and 30 minutes after injection||||Percentage of Participants|||Number
2668694|NCT01502423|Secondary|Percentage of Participants With no Erythema in the Draize Scale|Erythema (redness) was assessed.|10 minutes and 30 minutes after injection||||Percentage of Participants|||Number
2668695|NCT01502423|Secondary|Percentage of Participants With no Hemorrhage/Petechiae in the Draize Scale|Hemorrhage/petechiae (bleeding/spots of bleeding underneath the skin) was assessed.|10 minutes and 30 minutes after injection||||Percentage of Participants|||Number
2668696|NCT01502423|Secondary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|The secondary response variable is participant's pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm) recorded 15 minutes after the injection.|15 minutes post injection||||cm||Standard Deviation|Mean
2668697|NCT01502423|Primary|Mean Injection Site Pain on a Visual Analogue Scale (VAS)|The primary response variable is participant's immediate pain of injection on a visual analogue scale (VAS) of 0 to 10 (cm), with 0 representing no pain and 10 representing the worst possible pain.|Immediately after injection.||||cm||Standard Deviation|Mean
2668698|NCT01502410|Secondary|Presence of BRAF Mutation or RET/PTC Rearrangement|Descriptive statistics including mean, median, standard deviation, and range will be calculated for baseline for patients with PTC, TG and TG antibody, and presence of BRAF mutation or RET/PTC rearrangement.|At baseline|No patients were enrolled with PTC (papillary thyroid carcinoma) so there are no patients who can contribute to this outcome measure.||||||
2668699|NCT01502410|Secondary|Change in VEGF and VEGFR-2|Serum VEGF and VEGF receptor 2 Concentration is evaluated at baseline and at day 15 of protocol therapy in picograms/ml.|Prior to the administration of sorafenib (baseline) and day 15 of protocol therapy|Change in VEGF and VEGFR-2 are the responses of the patient's organs to the drug. As such, these measures are unrelated to the particular disease with which the patient was diagnosed, and were combined for analysis.|||picograms/ml||Full Range|Mean
2668700|NCT01502410|Secondary|Pharmacokinetic (PK) Parameters of Sorafenib Tosylate|The trough sorafenib concentration is evaluated at baseline (prior to administration of Sorafenib) and 12 hours after administration of Sorafenib on day 15, day 56, day 112 and day 168 in micrograms/ml.|Prior to administration of Sorafenib (baseline), day 15, day 56, day 112 and day 168|Baseline sample was available for only 9 participants.|||micrograms/ml||Full Range|Mean
2668701|NCT01502410|Secondary|The Number of Patients Who Experience at Least One Grade 3 or Higher CTC Version 4 Toxicity,|Each patient is classified as having experienced grade 3 or higher CTC version 4 toxicity if at any time during protocol therapy such an event is observed for the individual.|six cycles of chemotherapy; expected to be 126 days of treatment|All eligible patients diagnosed with Rhabdomyosarcoma or Wilms Tumor are combined in this analysis.|||Participants|||Count of Participants
2668702|NCT01502410|Secondary|Progression-free Survival According to RECIST Version 1.1|Percent probability of being progression free six months following enrollment. Progression-free interval (PFI) will be calculated as the date of enrollment until the end PFI date, where that date is calculated as the date of disease progression, date of death, date of removal of all tumors by surgery or last patient contact, whichever occurs first.|Six months after enrollment|All eligible patients are included in this analysis for both Rhabdomyosarcoma and Wilms Tumor. However, there were no accruals on the disease arms for Hepatocellular carcinoma and Papillary Thyroid carcinoma and were not included in this analysis.|||percentage of probability||95% Confidence Interval|Number
2668713|NCT01502306|Secondary|7-day Prevalence.|Seven-day point prevalence abstinence is a measure of, in this case, tobacco cessation outcomes for quitlines. At a given point in time (in this case, 7 months after program registration), quitline participants are asked whether they have used cigarettes or other forms of tobacco in the past 7 days.|7-months post enrollment|Number of participants analyzed reflects the number of participants the quitline was able to reach at 7-months|||Participants|||Count of Participants
2668703|NCT01502410|Primary|Objective Response by RECIST Criteria v 1.1|Response rates will be calculated as the number of evaluable patients who are responders. Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started and Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|6 cycles (168 days)|Only Rhabdomyosarcoma and Wilms Tumor patients are included in this analysis as there were no accruals on Hepatocellular carcinoma and no accruals on Thyroid carcinoma.|||participants|||Number
2668704|NCT01502371|Secondary|Change From Baseline in Percent Predicted AM FEV1 - MF MDI 50 mcg BID vs. MF DPI 100 mcg QD|FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the secondary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI 50 mcg BID and MF DPI 100 mcg QD treatment groups. The comparisons between the other MF MDI BID and Placebo treatment groups are presented in a previous outcome measure.|Baseline and Week 12|The FAS population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure. Only participants who received MF MDI 50 mcg or MF DPI were included in this secondary analysis.|||Percentage of Predicted FEV1||95% Confidence Interval|Least Squares Mean
2668705|NCT01502371|Secondary|Change From Baseline in Paediatric Asthma Quality of Life Questionnaire With Standardised Activities (PAQLQ(S)) Total Score - MF MDI vs. Placebo|The PAQLQ(S) consists of 23 questions in 3 categories: Symptoms (10 items), Activity Limitations (5 items), and Emotional Function (8 items). Responses are based on a 7-point scale (7=not bothered at all to 1=extremely bothered). PAQLQ(S) Total Scores could range from 23 to 161, with a lower score indicating a lower quality of life. The PAQLQ(S) included only participants in participating countries in which a validated translated questionnaire was available. The goal of the secondary outcome measure was to compare the change from Baseline in PAQLQ(S) between the MF MDI and Placebo treatment groups.|Baseline and Week 12|The FAS population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure.|||Score on a Scale||95% Confidence Interval|Least Squares Mean
2668706|NCT01502371|Secondary|Change From Baseline in AM Peak Expiratory Flow (PEF) - MF MDI vs. Placebo|PEF, measured in liters per minute, is the highest flow during exhalation. Participants recorded diary entries for PEF twice daily (in the morning upon rising and in the evening at bedtime). The goal of the secondary outcome measure was to compare the change from Baseline in AM PEF between the MF MDI and Placebo treatment groups.|Baseline and Week 12|The FAS population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure.|||Liters/minute||95% Confidence Interval|Least Squares Mean
2668707|NCT01502371|Primary|Change From Baseline in Percent Predicted Morning (AM) Forced Expiratory Volume in 1 Second (FEV1) - MF MDI vs. Placebo|FEV1 is the amount of air, measured in liters, forcibly exhaled in 1 second. Pulmonary function tests were to be performed by participants in the morning before dosing. The percent predicted FEV1 equals the participant's observed FEV1 divided by the participant's predicted FEV1 (determined by height and race) and converted to a percentage by multiplying by 100%. The goal of the primary outcome measure was to compare the change from Baseline in AM FEV1 between the MF MDI and Placebo treatment groups. The comparison between the MF MDI 50 mcg BID vs. MF DPI 100 mcg QD treatment groups is presented in a subsequent outcome measure.|Baseline and Week 12|The Full Analysis Set (FAS) population consisted of all participants who received ≥1 study drug dose and had a Baseline or ≥1 post-randomization value for this outcome measure. Only participants who received MF MDI or Placebo were included in this primary analysis.|||Percentage of Predicted FEV1||95% Confidence Interval|Least Squares Mean
2668708|NCT01502332|Secondary|Hospital Mortality|Deaths occurred during hospital stay, tested with logistic regression.|From the day of surgery up to Hospital discharge or death, with no maximum censoring.||||percentage of participants|||Number
2668709|NCT01502332|Secondary|Incidence of Barotrauma|Confirmed by X-ray. Test with logistic regression|Five days after surgery||||percentage of participants|||Number
2668710|NCT01502332|Secondary|Length of Hospital Stay|Days since surgery until Hospital discharge, analyzed through Kaplan-Meyer curves (log-Rank test), where the time to event is the time of discharge from the Hospital. The censoring was performed at 28 days. Patients dying before leaving the Hospital were censored as not discharged from Hospital at day 28.|From the day of surgery up to Hospital discharge, maximum censoring at day 28 after surgery||||days||Inter-Quartile Range|Median
2668711|NCT01502332|Secondary|Length of ICU Stay|Days since surgery until ICU discharge, analyzed through Kaplan-Meyer curves (log-Rank test), where the time to event is the time of discharge from the ICU. The censoring was performed at 28 days. Patients dying before leaving the ICU were censored as not discharged from ICU at day 28.|From the day of surgery up to ICU discharge, maximum censoring at day 28 after surgery||||days||Inter-Quartile Range|Median
2668712|NCT01502332|Primary|Severity of Pulmonary Complications in the Post-operative Period|"Score of pulmonary complications adapted from previous publications, with 5 degrees, where the higher one means death before hospital discharge, degree (4) means the need of mechanical ventilation for more than 48 hours after surgery or after reintubation, degree (3) means pneumonia or intense noninvasive ventilation need, degree (2) means hypoxemia and abnormal lung findings, degree 1 means simple atelectasis and degree (0) means no complication.~The comparison used this ordinal variable, representing the highest score achieved during the post-operative period. The comparison between arms was made through the Mann-Whitney U test.~Data shown are percentage of participants with pulmonary complications grade ≥ 3."|Participants were followed for the duration of hospital stay.||||percentage of participants|||Number
2668714|NCT01502306|Secondary|Continuous Abstinence Rates for Those Who Made Quit Attempts|Not smoking since the quit date|7-months post enrollment|Number of participants analyzed reflects the number of participants the quitline was able to reach at 7-months|||Participants|||Count of Participants
2668715|NCT01502306|Secondary|Percentage of Smokers Making a 24-hour Quit Attempt|At a given point in time (in this case, 2 months after program registration), quitline participants are asked whether they made a quit attempt (attempt at quitting smoking) and how long they made it.|2 months post enrollment|Number of participants analyzed reflects the number of participants the quitline was able to reach at 2-months|||Participants|||Count of Participants
2668716|NCT01502306|Primary|30-day Abstinence|At a given point in time (in this case, 7 months after program registration), quitline participants are asked whether they have used cigarettes or other forms of tobacco in the past 30 days. Those who reply that they have not used tobacco in the past 30 days are considered to have quit.|7 months post enrollment|Number of participants analyzed reflects the number of participants the quitline was able to reach at 7-months|||Participants|||Count of Participants
2668717|NCT01502293|Secondary|Regression Rate of Treated and Untreated Lesions|The treated (injected, electroporated) lesion regression rate is defined as the percentage of patients who had at least one treated lesion that decreased in longest dimension by ≥ 30%. The untreated (non-injected, non-electroporated) lesion regression rate is defined as the percentage of patients who had at least one untreated lesion that decreased in longest dimension by ≥ 30%.|Main Study: Screening and Days 1, 39, 90, 120, 180, 270, 360, End Of Study; Addendum: Screening and Weeks 12, 24, 36,28, End of Study|Efficacy Analysis Set, all enrolled patients who received at least one full cycle of study treatment and had at least one efficacy assessment following the first dose of study drug.|||percentage of participants|||Number
2668718|NCT01502293|Secondary|Median Progression Free Survival|Progression free survival (PFS) is defined as the duration between the date of treatment initiation (Study Day 1) to the first date of either disease progression at either local or distant sites, or death from any cause. Disease progression at local or distant lesions is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Patients were censored at their last assessment date if there was no evidence of disease progression.|From start of study treatment until disease progression or death (Up to 29.7 months)|Efficacy Analysis Set, all enrolled patients who received at least one full cycle of study treatment and had at least one efficacy assessment following the first dose of study drug, who had at least one post-baseline response assessment and had a CR or PR based on Modified RECIST criteria.|||days||95% Confidence Interval|Median
2668719|NCT01502293|Secondary|Time to First Objective Response|Time to objective response (CR or PR based on Modified RECIST criteria) is defined as the number of days between the date of treatment initiation (Study Day 1) to the first date of the first documentation of an objective response. CR: complete disappearance of all lesions (whether measurable or not) and the absence of new lesions for at least 4 weeks duration, confirmed by additional scan and visit 4 to 6 weeks after first documentation of CR. PR: ≥30% decrease in longest dimension (LD) from baseline lesion, and no new lesions. Patients who had an initial response and did not progress were censored at their date of last assessment. Patients who did not have an objective response were censored at their date of last assessment.|From start of study treatment until overall objective response (Up to 29.7 months)|Efficacy Analysis Set, all enrolled patients who received at least one full cycle of study treatment and had at least one efficacy assessment following the first dose of study drug, who had at least one post-baseline response assessment and had a CR or PR.|||days||Full Range|Median
2668720|NCT01502293|Secondary|Duration of Objective Response|Duration of objective response (CR or PR based on Modified RECIST criteria) is defined as the number of days from the initial documentation of an objective response to the most current evaluation of that response or to documentation of progression or death associated with disease progression. CR: complete disappearance of all lesions (whether measurable or not) and the absence of new lesions for at least 4 weeks duration, confirmed by additional scan and visit 4 to 6 weeks after first documentation of CR. PR: ≥30% decrease in longest dimension (LD) from baseline lesion, and no new lesions. Patients who had an initial response and did not progress were censored at their date of last assessment.|From first documented response until disease progression (Up to 29.7 months)|Efficacy Analysis Set, all enrolled patients who received at least one full cycle of study treatment and had at least one efficacy assessment following the first dose of study drug, who had at least one post-baseline response assessment and had a CR or PR.|||days||Full Range|Median
2668721|NCT01502293|Secondary|Objective Response Rate (ORR) by Immune Related Response Criteria (irRC)|ORR is defined as the percentage of participants with evaluable lesions that achieved a complete response (CR) or partial response (PR) as assessed by the investigator using irRC criteria. CR: complete disappearance of all lesions (whether measurable or not) and the absence of new lesions for at least 4 weeks duration, confirmed by additional scan and visit 4 to 6 weeks after first documentation of CR. PR: ≥50% decrease in the product of the diameters from baseline.|Main Study: Screening and Days 90, 180, 270 and 360; Addendum: Screening and Weeks 12, 24, 36, and 48|Efficacy Analysis Set, all enrolled patients who received at least one full cycle of study treatment and had at least one efficacy assessment following the first dose of study drug, who had at least one post-baseline response assessment.|||percentage of participants|||Number
2668722|NCT01502293|Secondary|Median Overall Survival (OS)|Overall survival (OS) time is defined as the duration between the date of treatment initiation (Study Day 1) to the date of death, regardless of the cause of death, assessed up to 30 months.|From the start of study treatment until death, assessed up to 30 months.|Efficacy Analysis Set, all enrolled patients who received at least one full cycle of study treatment and had at least one efficacy assessment following the first dose of study drug. Patients were censored at the last date that they were known to be alive.|||days||95% Confidence Interval|Median
2668734|NCT01501955|Secondary|WOMAC Pain|WOMAC Score presented in Pain (range 0-20), Stiffness (range 0-8) and Function (range 0-68) component Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the WOMAC Score was performed for all fully completed score forms.|||units on a scale||Standard Deviation|Mean
2676098|NCT01441102|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at 24 Months Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Baseline and 24 Months||||dB|eyes|Standard Deviation|Mean
2668723|NCT01502293|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, medical treatment or procedure and which did not necessarily have to have had a causal relationship with this treatment. An adverse event could have, therefore, been any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, medical treatment or procedure whether or not considered related to the medicinal product. An SAE was defined an any untoward medical occurrence that at any dosage resulted in one or more of the following: death, A life-threatening adverse event (real risk of dying), inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly, required intervention to prevent permanent impairment of damage.|From first administration of study treatment up to 30 days after last dose or until initiation of new anti-cancer treatment.|Safety Analysis Set, all patients who were enrolled and received any amount of the study treatment (pIL-12).|||percentage of participants|||Number
2668724|NCT01502293|Primary|"Best Overall Objective Response Rate (ORR) by Modified Skin RECIST"|"ORR is defined as the percentage of participants with evaluable lesions that achieved a complete response (CR) or partial response (PR) as assessed by the investigator using Modified Skin Response Evaluation Criteria In Solid Tumors (RECIST). CR: complete disappearance of all lesions (whether measurable or not) and the absence of new lesions for at least 4 weeks duration, confirmed by additional scan and visit 4 to 6 weeks after first documentation of CR. PR: ≥30% decrease in longest dimension (LD) from baseline lesion, and no new lesions."|Main Study: Screening and Days 90, 180, 270 and 360; Addendum: Screening and Weeks 12, 24, 36, and 48|Efficacy Analysis Set, all enrolled patients who received at least one full cycle of study treatment and had at least one efficacy assessment following the first dose of study drug, who had at least one post-baseline response assessment.|||percentage of participants|||Number
2668725|NCT01502228|Secondary|Maximum Standard Uptake Value (SUV) for Lesion Data|Average values of the magnitude of tumor perfusion before and 14-28 days after initiation of Sunitinib treatment as measured by the maximum standard uptake value for all the lesion data. Standard uptake values were calculated as the ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity tracer. There were 14 patients who had a baseline reading and 12 patients who had a reading after treatment.|Baseline and 14-28 days after initiation of Sunitinib||||SUV||Standard Deviation|Mean
2668726|NCT01502228|Primary|Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained|Number of patients who had at least a baseline measurement of 62Cu-ETS PET and 15O-water PET|Baseline|All Patients Enrolled.|||Participants|||Count of Participants
2668727|NCT01502033|Secondary|The Clinical Global Impression - Improvement (CGI-I)|The Clinical Global Impression - Improvement (CGI-I) is a standardized assessment utilizing a 7-point scale with which the clinician rates improvment of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= very much improved, 7=very much worse) larger number indicates greater severity of symptoms or worse outcome).|Within 5 days of 30 treatments or after last treatment in case of early withdrawal||||units on a scale||Standard Deviation|Mean
2668728|NCT01502033|Secondary|Clinical Global Impression - Severity (CGI-S) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)|The Clinical Global Impression - Severity (CGI-S) is a standardized assessment utilizing a 7-point scale with which the clinician rates severity of the subject's depressive illness at the time of assessment relative to the clinician's past experience with patients with the same diagnosis. Range of scale is 1-7 (1= normal, not ill at all; 7= among the most ill patients; larger number indicates greater severity of symptoms or worse outcome).|Within 5 days of Treatment 30 or Last Treatment||||units on a scale||Standard Deviation|Mean
2668729|NCT01502033|Primary|Children's Depression Rating Scale-Revised (CDRS-R) Post Treatment 30 or Last Treatment (in Cases of Early Withdrawal)|The Children's Depression Rating Scale-Revised (CDRS-R) is a validated, 17-item, semi-structured clinician rating tool to assess severity of depression with subject and parental input for 14 of the 17 items.|5 days of Treatment 30 or Last Treatment||||units on a scale||Standard Deviation|Mean
2668730|NCT01501955|Secondary|SF-12 Mental Summary Score|SF-12 Score presented in Physical and Mental summary scores (range 0-100). A zero score indicates the lowest level of health and 100 indicates the highest level of health.|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the SF-12 Score was performed for all fully completed score forms.|||units on a scale||Standard Deviation|Mean
2668731|NCT01501955|Secondary|SF-12 Physical Summary Score|"12-Item Short-Form Health Survey (SF-12) presented in Physical (PS) and Mental summary (MS) scores (range 0-100).~A zero score indicates the lowest level of health and 100 indicates the highest level of health."|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the SF-12 Score was performed for all fully completed score forms.|||units on a scale||Standard Deviation|Mean
2668732|NCT01501955|Secondary|WOMAC Function|"WOMAC Score presented in Pain (range 0-20), Stiffness (range 0-8) and Function (range 0-68) component.~Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations."|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the WOMAC Score was performed for all fully completed score forms.|||units on a scale||Standard Deviation|Mean
2668733|NCT01501955|Secondary|WOMAC Stiffness|"Western Ontario and McMaster Osteoarthritis Index (WOMAC) presented in Pain (range 0-20), Stiffness (range 0-8) and Function (range 0-68) component.~Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations."|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the WOMAC Score was performed for all fully completed score forms.|||units on a scale||Standard Deviation|Mean
2676099|NCT01441102|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at 18 Months Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Baseline and 18 Months||||dB|eyes|Standard Deviation|Mean
2668735|NCT01501955|Secondary|HOOS-QoL Subscale|HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the HOOS Score was performed for all valid completed score forms.|||units on a scale||Standard Deviation|Mean
2668736|NCT01501955|Secondary|HOOS-Sport Subscale|HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the HOOS Score was performed for all valid completed score forms.|||units on a scale||Standard Deviation|Mean
2668737|NCT01501955|Secondary|HOOS-ADL Subscale|HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the HOOS Score was performed for all valid completed score forms.|||units on a scale||Standard Deviation|Mean
2668738|NCT01501955|Secondary|HOOS-Symptom Subscale|HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the HOOS Score was performed for all valid completed score forms.|||units on a scale||Standard Deviation|Mean
2668739|NCT01501955|Secondary|HOOS-Pain Subscale|HOOS (Hip disability and Osteoarthritis Outcome Score) consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the HOOS Score was performed for all valid completed score forms.|||units on a scale||Standard Deviation|Mean
2668740|NCT01501955|Secondary|DEXA|"Efficacy:~Bone density measured using DEXA"|10 years postoperative|||||||
2668741|NCT01501955|Secondary|Harris Hip Score|"Harris Hip Score (HHS), a score to measure health and satisfaction after a hip prosthesis.~The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points)"|pre-operatively, 6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment. Analysis of the Harris Hip Score was performed for all fully completed score forms.|||Scores on a scale||Standard Deviation|Mean
2668742|NCT01501955|Secondary|Number of Reported Device Related Complications|"Safety:~- Frequency of serious device related complications."|6 weeks, 3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with surgery as part of the study. Analysis was performed based on per protocol treatment.|||participants|||Number
2668743|NCT01501955|Primary|RSA MTMP|Maximum Total Point Motion (MTPM) measured with RSA. This is a mean for the total migration of the stem.|3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.|||mm||Standard Deviation|Mean
2668744|NCT01501955|Primary|RSA Rotation Z|Stem rotation around the z-axis in degrees (measured with RSA)|3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.|||mm||Standard Deviation|Mean
2668745|NCT01501955|Primary|RSA Rotation Y|Stem rotation around the y-axis in degrees ( measured with RSA)|3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.|||mm||Standard Deviation|Mean
2668746|NCT01501955|Primary|RSA Rotation X|Stem Rotation around X-axis in degrees (measured with RSA)|3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.|||mm||Standard Deviation|Mean
2668747|NCT01501955|Primary|RSA Translation Z|Stem movement along z-axis in mm (measured with RSA)|3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.|||mm||Standard Deviation|Mean
2668748|NCT01501955|Primary|RSA Translation Y|Stem movement along the y-axis in mm. (measured with RSA)|3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.|||mm||Standard Deviation|Mean
2668749|NCT01501955|Primary|RSA Translation X|Stem movement measured with RSA (radiostereometric analysis) along the x-axis in mm. RSA is a technique to accurately measure 3D movement of the prosthesis in the bone. The movement is measured with respect to the situation directly postoperative.|3 months, 6 months, 1 year and 2 years postoperatively|The population analyzed included all participants with a valid RSA baseline X-ray taken direct postoperatively and with a valid RSA X-ray at the respective time interval. Analysis was performed based on per protocol treatment.|||mm||Standard Deviation|Mean
2668750|NCT01501929|Primary|Microvascular Blood Flow|Microvascular perfusion of skeletal muscle were measured during handgrip at 20 cycle per minute after 12 weeks of metoprolol, and after 12 weeks of nebivolol|12 weeks||||video intensity units/ second||Inter-Quartile Range|Median
2668751|NCT01501929|Primary|Endothelial Cell Protein Expression p47phox From Endothelial Cell Collection|Endothelial cell (EC) was collected after a 20-guage angiocatheter was inserted into the contralateral forearm vein under sterile conditions. Three J-shaped vascular guidewires (St. Jude, St. Paul, MN) were advanced sequentially into the vein up to 10 cm. Endothelial cells were collected by gentle abrasion and placed into a dissociation buffer (0.5% bovine serum albumin, 2mM EDTA, and 100 ug/ml heparin in PBS). Endothelial cells were recovered from the tips of guide wires by repeated washing into collection tubes and subsequent centrifugation. EC were incubated with monoclonal antibodies against the polyclonal antibodies against NADPH oxidase p47 subunit. The intensity of staining was measured using fluorescence microscopy.|12 weeks||||Ratio human to HUVEC p47Phox expression||Standard Error|Mean
2668752|NCT01501162|Secondary|Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines|For the measurements of cytokines, homogenates of serum were processed with Human Tumor necrosis factor-alpha ELISA Kit and Human interleukin 1 beta ELISA Kit . For the measurement of LPS ELISA Kit was used. Assays were performed according to the manufacturer's instructions.|7 days after probiotics||||EU/mL||Standard Deviation|Mean
2668753|NCT01501162|Primary|Liver Enzymes(ALT)|Blood analysis was performed using standard methodologies.|7 days after probiotics||||IU/L||Standard Deviation|Mean
2668754|NCT01501110|Primary|Serum T3 Levels at 48 Hours||48 hours||||ng/dL||Standard Deviation|Mean
2668755|NCT01500772|Secondary|Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events||48 weeks|The study was terminated before the outcome measure time point.||||||
2668756|NCT01500772|Secondary|Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD)|Level of detection (LOD) was defined as 10 IU/mL|12 weeks posttreatment|The study was terminated before the outcome measure time point.||||||
2668757|NCT01500772|Secondary|Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)|SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.|24 weeks posttreatment|The study was terminated before the outcome measure time point.||||||
2668758|NCT01500772|Primary|Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12)|SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment.|12 weeks posttreatment|The study was terminated before the outcome measure time point.||||||
2668759|NCT01500746|Secondary|Pain With Lavage Treatments|After each lavage treatment, the subjects will complete a visual analogue scale that will determine the level of discomfort that they experienced during the study.|4 days|||||||
2668760|NCT01500746|Primary|Change in Gene Expression Analysis|A punch biopsy will be taken at the beginning of the study. this will be sent for gene expression analysis. A repeat biopsy at the end of the study will also be sent at the end of the study, and a change in gene expression in analysis will be evaluated.|4 days|||||||
2668761|NCT01500746|Primary|Change in Bacterial Counts|A punch biopsy of the wound will be taken once the subject is enrolled in the study. A repeat biopsy will be taken after the 8th lavage treatment or the 8th dressing change. These will be sent for bacterial count analysis and the difference in bacterial counts will be evaluated. The lavage fluid from baseline measurements will be filtered and sent for bacterial counts and will be compared to the filtered fluid from the last lavage treatment. In addition, surface swabs will be taken at the beginning and end of the study and will be sent for bacterial counts as well. Bacterial counts from these lavage, biopsy specimen, and swabs will be averaged and analyzed.|Baseline and at 4 days||||cfu/mL||Full Range|Mean
2668762|NCT01500733|Primary|Overall Response Rate at 6 Months|"The primary endpoint was response after 6 cycles of therapy. Overall response rate was calculated as complete response plus partial response, based on the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2008 criteria.as follows:~Complete response (CR): all group A and group B criteria are met~Group A criteria: resolution of enlarged lymph nodes, normal size spleen and liver, absolute lymphocyte count < 4,000/uL, normocellular bone marrow with < 30% lymphocytes without nodules~Group B criteria: improved blood count (platelet count > 100,000/uL, hemoglobin > 11.0 g/dL, neutrophils > 1,500/uL)~Partial response (PR): at least 2 of the group A criteria plus one of the group B criteria are met~Group A criteria: >=50% decrease in target lymph nodes, >=50% decrease in spleen size, >=50% decrease in liver size, 50% reduction in marrow infiltrates~Group B criteria: platelet count > 100,000/uL, hemoglobin > 11.0 g/dL, neutrophils > 1,500/uL"|6 months|The analyses included only those subjects who received ibrutinib, and completed 6 cycles of therapy.|||percentage of participants||95% Confidence Interval|Number
2668763|NCT01500720|Secondary|Overall Objective Tumor Response Rate|Overall objective tumor response was defined as the proportion of participants with confirmed RECIST 1.1 achieving a complete response (CR) or partial response (PR). CR was defined as disappearance of all target/non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Percentage of participants with overall objective tumor response is reported.|Randomization to disease progression/occurrence (maximum 7.6 months)|ITT population.|||percentage of participants||95% Confidence Interval|Number
2668764|NCT01500720|Secondary|Progression Free Rate at Week 12|Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. Death due to disease progression within 12 weeks without radiological documentation of progressive disease was counted as an event. Percentage of participants who were progression free at week 12 are reported.|Week 12|ITT population.|||percentage of participants||95% Confidence Interval|Number
2668765|NCT01500720|Secondary|Overall Survival|Overall survival was defined as the time interval from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was to be censored at the last date the participant was known to be alive. Median time was estimated by Kaplan-Meier curve.|From randomization to date of death (maximum 15 months)|ITT population.|||months||95% Confidence Interval|Median
2668766|NCT01500720|Primary|Progression Free Survival (PFS)|PFS was defined as the time interval from the date of randomization to the date of occurrence of the first documented tumor progression or death due to any cause, whichever came first. Median PFS was estimated using the Kaplan-Meier method. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study or unequivocal progression of existing non-target lesion. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.|Randomization to first tumor progression/clinical deterioration or death (maximum 7.6 months)|Intent-to-treat (ITT) population included all randomized participants.|||months||95% Confidence Interval|Median
2668767|NCT01500694|Secondary|Number of Participants Assessed With Clinical Global Impression Severity of Illness (CGI-S) Scale|The CGI-S evaluate each participant's severity and improvement over time. The severity of a participant's condition is rated on a 7-point scale ranging from 1 to 7. The scale measures 0 = Not assessed, 1 = Normal, not at all ill, 2 = Borderline mentally ill (BL-MI), 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Among the most extremely ill participant. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Full Analysis Set included enrolled participants who took at least 1 dose of SPD503, excluding participants from site 403. Here, n = number of participants analysed for the specific categories for each arm respectively.|||participants|||Number
2668768|NCT01500694|Secondary|Change From Baseline in Attention-deficit and Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) - Total Score at Final Assessment|ADHD-RS-IV was developed to measure the behaviours of children with ADHD with 18 items. Each item is scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items may be grouped into 2 subscales: hyperactivity/impulsivity (even numbered items 2-18) and inattentiveness (odd numbered items 1-17) with possible score range from 0 (no symptoms) to 27 (most severe symptoms). The ADHD-RS-IV possible total scores range from 0 (no symptoms) to 54 (most severe symptoms). Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Full Analysis Set included enrolled participants who took at least 1 dose of SPD503, excluding participants from site 403. Here, n = number of participants analysed for the specific categories for each arm respectively.|||units on a scale||Standard Error|Mean
2668769|NCT01500694|Primary|"Number of Participants With Suicidal Behavior and / or Ideation (Yes Response) on the Columbia Suicide Severity Rating Scale (C-SSRS)"|"C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a yes response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a yes response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent)."|Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503 with number of participants evaluable for this outcome at specific categories.|||participants|||Number
2668770|NCT01500694|Primary|Change From Baseline in Electrocardiogram Result (QT Interval) at Final Assessment|Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.|||millisecond (ms)||Standard Deviation|Mean
2668771|NCT01500694|Primary|Change From Baseline in Electrocardiogram Result (QRS Interval) at Final Assessment|Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.|||millisecond (ms)||Standard Deviation|Mean
2668772|NCT01500694|Primary|Change From Baseline in Mean Weight at Final Assessment|Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.|||kilogram (kg)||Standard Deviation|Mean
2668826|NCT01500434|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668773|NCT01500694|Primary|Change From Baseline in Mean Height at Final Assessment|Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.|||centimeter (cm)||Standard Deviation|Mean
2668774|NCT01500694|Primary|Change From Baseline in Mean Supine Pulse at Final Assessment|Pulse was measured at supine and standing position and mean supine pulse was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.|||beats per minute (bpm)||Standard Deviation|Mean
2668775|NCT01500694|Primary|Change From Baseline in Mean Diastolic Blood Pressure at Final Assessment|Diastolic Blood pressure was measured at supine and standing position and mean supine diastolic blood pressure was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set included all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2668776|NCT01500694|Primary|Change From Baseline in Mean Systolic Blood Pressure at Final Assessment|Systolic Blood pressure was measured at supine and standing position and mean supine systolic blood pressure was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication [Visit 19/Early Termination (ET)/Day 714].|Baseline (Day 0) and Final Assessment (last non missing data/up to Day 714)|Safety Analysis Set includes all enrolled participants who took at least 1 dose of SPD503. Here, n = number of participants analysed for the specific categories for each arm respectively.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2668777|NCT01500629|Secondary|Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 1 Hour After the Second Allergen Challenge|TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
2668778|NCT01500629|Secondary|Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 15 Minutes After the Second Allergen Challenge|TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
2668779|NCT01500629|Secondary|Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 1 Hour After the First Allergen Challenge|TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
2668780|NCT01500629|Secondary|Change From Baseline of the Total Score From the Following Nasal Symptoms (TNSSX [Total Nasal Symptom Score Excluding Sneezing]): Itchy Nose, Runny Nose, Nasal Congestion at 15 Minutes After the First Allergen Challenge|TNSSX was derived by taking the sum of the average score of left and right nostrils for itchy nose, runny nose, and nasal congestion. Change from baseline of TNSSX was TNSSX for each post baseline time point minus its baseline. For the change from baseline of TNSSX, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
2668781|NCT01500629|Secondary|Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the Second Allergen Challenge|A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||participants|||Number
2668782|NCT01500629|Secondary|Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the Second Allergen Challenge|A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||participants|||Number
2668783|NCT01500629|Secondary|Within Subject Improvement From Placebo in TNSS (Responder) at 1 Hour After the First Allergen Challenge|A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||participants|||Number
2668784|NCT01500629|Secondary|Within Subject Improvement From Placebo in TNSS (Responder) at 15 Minutes After the First Allergen Challenge|A responder was defined as within subject improvement from placebo in TNSS with improvement from placebo based on the change from baseline for TNSS.|within 15 minutes||||participants|||Number
2676100|NCT01441102|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at 12 Months Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Baseline and 12 Months||||dB|eyes|Standard Deviation|Mean
2668785|NCT01500629|Secondary|Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the Second Allergen Challenge|Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
2668786|NCT01500629|Secondary|Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the Second Allergen Challenge|Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
2668787|NCT01500629|Secondary|Change From Baseline of Non Nasal Symptoms Score (NNSS) at 1 Hour After the First Allergen Challenge|Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
2668788|NCT01500629|Secondary|Change From Baseline of Non Nasal Symptoms Score (NNSS) at 15 Minutes After the First Allergen Challenge|Subjects evaluated non nasal symptoms of itchy throat, ear, and palate using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of NNSS was calculated by taking the difference of the NNSS score for each post baseline time point minus its baseline. For the NNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
2668789|NCT01500629|Secondary|Total Ocular Symptoms Score (TOSS) at 1 Hour After the Second Allergen Challenge|Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
2668790|NCT01500629|Secondary|Total Ocular Symptoms Score (TOSS) at 15 Minutes After the Second Allergen Challenge|Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
2668791|NCT01500629|Secondary|Total Ocular Symptoms Score (TOSS) at 1 Hour After the First Allergen Challenge|Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
2668792|NCT01500629|Secondary|Total Ocular Symptoms Score (TOSS) at 15 Minutes After the First Allergen Challenge|Subjects evaluated ocular symptoms of itchy eyes, watery eyes, and redness of eyes using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The TOSS was calculated by taking the sum of each average score (left and right eyes) for itchy eyes, watery eyes, and redness of eyes. For the TOSS, the total possible minimum value is 0 (best) and the total possible maximum value is 9 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
2668793|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2668794|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2668827|NCT01500434|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668795|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 1 Hour After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2668796|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Nasal Congestion at 15 Minutes After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of nasal congestion using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for nasal congestion was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for nasal congestion, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2668797|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2668798|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2668799|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 1 Hour After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2668800|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Runny Nose at 15 Minutes After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of runny nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for runny nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for runny nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2668801|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2668802|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2668803|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 1 Hour After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2669728|NCT01493089|Secondary|Percentage of Patients Responding in 60 Minutes|Proportion of patients who have achieved sustained response, sustained partial response or sustained total relief by 60 minutes|14 days|mITT|||Percentage of patients||95% Confidence Interval|Number
2668804|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Itchy Nose at 15 Minutes After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of itchy nose using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for itchy nose was then calculated by taking the average score of the left and right nostrils for each score from each post baseline time point minus its baseline score. For the change from baseline in the individual NSS for itchy nose, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2668805|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2668806|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the Second Allergen Challenge|Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2668807|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 1 Hour After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2668808|NCT01500629|Secondary|Change From Baseline of Individual Nasal Symptoms Score (NSS) for Sneezing at 15 Minutes After the First Allergen Challenge|Subjects evaluated the individual nasal symptom of sneezing using a scale of 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The change from baseline of the individual NSS for sneezing was then calculated by taking the score at the post baseline time point minus its baseline score. For the change from baseline in the individual NSS for sneezing, the total possible minimum value is 0 (best) and the total possible maximum value is 3 (worst).|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2668809|NCT01500629|Secondary|Change From Baseline in Number of Sneezes at 1 Hour After the Second Allergen Challenge|Change from baseline in number of sneezes|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||sneezes||Standard Deviation|Mean
2668810|NCT01500629|Secondary|Change From Baseline in Number of Sneezes at 15 Minutes After the Second Allergen Challenge|Change from baseline in number of sneezes|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||sneezes||Standard Deviation|Mean
2668811|NCT01500629|Secondary|Change From Baseline in Number of Sneezes at 1 Hour After the First Allergen Challenge|Change from baseline in number of sneezes|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||sneezes||Standard Deviation|Mean
2668812|NCT01500629|Secondary|Change From Baseline in Number of Sneezes at 15 Minutes After the First Allergen Challenge|Change from baseline in number of sneezes|Within 15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||sneezes||Standard Deviation|Mean
2668813|NCT01500629|Secondary|Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the Second Allergen Challenge|The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 1 hour after the second allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst).|Within 1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
2668814|NCT01500629|Secondary|Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the Second Allergen Challenge|The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 15 minutes after the second allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst).|15 minutes|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Deviation|Mean
2668840|NCT01500434|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.|6 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2669729|NCT01493089|Secondary|Percentage of Patients Responding in 45 Minutes|percentage of patients who have achieved sustained partial response, sustained response, or sustained total relief, by 45 minutes|up to 14 days|mITT|||percentage of patients||95% Confidence Interval|Number
2668815|NCT01500629|Secondary|Change From Baseline in the Total Nasal Symptom Score (TNSS) at 1 Hour After the First Allergen Challenge|The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 1 hour after the first allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst).|1 hour|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
2668816|NCT01500629|Primary|Change From Baseline in the Total Nasal Symptom Score (TNSS) at 15 Minutes After the First Allergan Challenge|The change from baseline in TNSS of sneezing, itchy nose, runny nose, and nasal congestion at 15 minutes after the first allergen challenge. TNSS was the sum of the severity of sneezing and the average score (left and right nostrils) for each of the following: itchy nose, runny nose, and nasal congestion. Severity of sneezing, itchy nose, runny nose, and nasal congestion were evaluated using a 4-point categorical scale where 0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe. For the change from baseline in TNSS, the total possible minimum value is 0 (best) and the total possible maximum value is 12 (worst).|15 minutes (±5 minutes)|Analysis is based on the Intent-to-Treat (ITT) set, which included all randomized subjects.|||units on a scale||Standard Error|Mean
2668817|NCT01500434|Secondary|Clinical Procedural Success|Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital MI, TVR, or cardiac death|In hospital (average of 1-2 days post index procedure)|Analysis was intention to treat|||percentage of participants|||Number
2668818|NCT01500434|Secondary|Acute Technical Success|Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent|Index Procedure|Analysis was intention to treat|||percentage of stents|stents||Number
2668819|NCT01500434|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|31-365 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668820|NCT01500434|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|>24 hours-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668821|NCT01500434|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668822|NCT01500434|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668823|NCT01500434|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668824|NCT01500434|Secondary|Target Vessel Revascularization (TVR)|TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668825|NCT01500434|Secondary|Target Lesion Revascularization (TLR)|TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668841|NCT01500434|Secondary|Target Lesion Failure (TLF)|TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.|30 Days|Analysis was intention to treat; all participants underwent clinical follow-up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668828|NCT01500434|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×normal|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668829|NCT01500434|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×normal|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668830|NCT01500434|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase-myoglobin band (CK-MB) or troponin >normal; if no new Q-waves total CK levels >3×normal (peri-percutaneous coronary intervention[PCI]) or >2×normal (spontaneous) with elevated CK-MB or troponin >3×normal (peri-PCI) or >2×normal (spontaneous) plus at least 1 of the following: ECG changes showing new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×normal|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668831|NCT01500434|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute MI; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668832|NCT01500434|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute MI; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668833|NCT01500434|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as Death due to any of the following: acute MI; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668834|NCT01500434|Secondary|All Cause Death||12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668835|NCT01500434|Secondary|All Cause Death||6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668836|NCT01500434|Secondary|All Cause Death||30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668837|NCT01500434|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668838|NCT01500434|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2668839|NCT01500434|Secondary|Target Vessel Failure (TVF)|TVF is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2669730|NCT01493089|Secondary|Median Time to Sustained Total Relief|Time to sustained total relief, defined as zero severity (no heartburn) on a 9-point Likert severity scale, which is sustained for 45 minutes or more|14 days|mITT|||Minutes||95% Confidence Interval|Median
2668842|NCT01500434|Primary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.|12 months|The primary analysis set for comparison of the primary endpoint, 12-month TLF, to the predefined performance goal of 21.1% (based on historical TAXUS Express results) is the per-protocol analysis set. All enrolled participants who received a PROMUS Element stent are included in the per-protocol analysis set.|||percentage of participants|||Number
2668843|NCT01500382|Primary|Number of Participants Who Discontinued Use of Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. The number of participants who discontinued study drug due to an AE were reported.|Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2)|The AST population, which included all participants who received at least one dose of study drug, was used for the safety evaluation. AEs are reported/grouped by drug taken at the time and not by randomly assigned sequence.|||Participants|||Number
2668844|NCT01500382|Primary|Number of Participants Who Experienced an Adverse Event (AE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Up to 6 weeks (up to 3 weeks in Period 1 and up to 3 weeks in Period 2)|The All Subjects as Treated (AST) population, which included all participants who received at least one dose of study drug, was used for the safety evaluation. AEs are reported/grouped by drug taken at the time and not by randomly assigned sequence.|||Participants|||Number
2668845|NCT01500382|Secondary|Fold-change From Baseline in Volume of Urine at First Desire to Void Post-dose on Day 7|Filling cystometry procedures were performed pre-dose on Day 1 and post-dose on Day 7 in each treatment period. Individual values in fold-change from baseline and post-dose on Day 7 will be natural log-transformed and evaluated with a linear mixed effects model having period and treatment as fixed effects and participant as a random effect.|Baseline (pre-dose Day 1) and Day 7 (post-dose)|Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed.||||||
2668846|NCT01500382|Primary|Fold-change From Baseline in Maximum Cystometric Capacity Post-dose on Day 7|Filling cystometry procedures were performed pre-dose on Day 1 and post-dose on Day 7 in each treatment period. Individual values in fold-change from baseline and post-dose on Day 7 will be natural log-transformed and evaluated with a linear mixed effects model having period and treatment as fixed effects and participant as a random effect.|Baseline (pre-dose Day 1) and Day 7 (post-dose)|Study was terminated by the Sponsor prior to completion. No planned efficacy summaries or analyses were completed.||||||
2668847|NCT01500317|Secondary|Ascending Colon Emptying (AC t1/2)|Ascending colon emptying t1/2 will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 24 hour data.|Over the first 24 hours after ingestion of the radioisotopically labeled charcoal particles||||hours||Standard Deviation|Mean
2668848|NCT01500317|Secondary|Colonic Filling at 6 Hours|Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.|6 hours||||percentage of radio-labeled meal||Standard Deviation|Mean
2668849|NCT01500317|Primary|Gastric Emptying Half-time (t1/2) at 24 Hours||24 hours||||minutes||Standard Deviation|Mean
2668850|NCT01500317|Secondary|Colonic Geometric Center at 8 and 48 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|8 hours, 48 hours||||units on a scale||Standard Deviation|Mean
2668851|NCT01500317|Primary|Colonic Transit, Geometric Center at 24 Hours|The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.|24 hours||||units on a scale||Standard Deviation|Mean
2668852|NCT01500278|Secondary|Kaplan-Meier Estimates of Proportion of Subjects Who Discontinued After Response at Week 12|Response at Week 12 means that a subject had either a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 12 or had a reduction of DAS28 [ESR] ≥ 1.2 from Baseline to Week 12. Kaplan-Meier Estimates of Proportion of Subjects Discontinued are presented per study week (days relative to Week 12 visit).|From Week 12 up to Week 104|Week 12 Responders were defined as those with DAS28(ESR) LDA (defined as DAS28[ESR] ≤3.2) or a DAS28(ESR) CFB reduction of ≥1.2 at Week 12.|||proportion of subjects|||Number
2668853|NCT01500278|Secondary|Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 104|HAQ-DI was derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question was scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), and the total HAQ-DI was scored on the scale of 0-3 as well. Change from Baseline was computed as the value at Week 104 minus the Baseline value. A negative value in Change from Baseline indicates an improvement.|From Baseline to Week 104|The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.|||Units on a Scale||Standard Error|Least Squares Mean
2668864|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Pain Score From 5 Years Postoperative to 10 Years Postoperative|"This index assesses pain as reported by the patient. The WOMAC Pain scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).~The change score was calculated by subtracting the five year score from the 10 year score."|5 years postoperative to 10 years postoperative|Two subjects, one in the patellar retention group and one in the patellar resurfacing group missed too many responses on the WOMAC questionnaire and was not included in the analysis.|||units on a scale||Standard Deviation|Mean
2668854|NCT01500278|Secondary|Percentage of Subjects With a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104, in Subjects Responding at Both Week 6 and Week 12|"DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.~The definition of Week 6/12 responders was DAS28[ESR] Low Disease Activity (LDA) (ie ≤ 3.2) or an improvement of ≥ 1.2 in DAS28[ESR] relative to Baseline."|Week 104|Week 12 Responders were defined as those with DAS28(ESR) LDA (defined as DAS28[ESR] ≤3.2) or a DAS28(ESR) CFB reduction of ≥1.2 at Week 12. Only subjects responding at both Week 6 and Week 12 are included in this analysis.|||Percentage of subjects|||Number
2668855|NCT01500278|Secondary|Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 12|DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.|Week 12|The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.|||Percentage of subjects|||Number
2668856|NCT01500278|Secondary|Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 6|DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.|Week 6|The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.|||Percentage of subjects|||Number
2668857|NCT01500278|Secondary|Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 6|Subjects who met the ACR20 criteria were those subjects with at least 20% improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).|Week 6|The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.|||Percentage of subjects|||Number
2668858|NCT01500278|Secondary|Percentage of Week 12 Responders Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104|"DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.~The definition of Week 12 responders was DAS28[ESR] Low Disease Activity (LDA) (ie ≤ 3.2) or an improvement of ≥ 1.2 in DAS28[ESR] relative to Baseline."|Week 104|Week 12 Responders were defined as those with DAS28(ESR) LDA (defined as DAS28[ESR] ≤3.2) or a DAS28(ESR) CFB reduction of ≥1.2 at Week 12.|||Percentage of subjects|||Number
2668859|NCT01500278|Primary|Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104|DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.|Week 104|The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.|||Percentage of subjects|||Number
2668860|NCT01500278|Primary|Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 12|Subjects who met the ACR20 criteria were those subjects with at least 20% improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).|Week 12|The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.|||Percentage of subjects|||Number
2668861|NCT01500252|Secondary|Number of Revision Surgeries|This measure examined the number of reoperation in the two groups of subjects|10 years|All participants were analyzed.|||participants|||Number
2668862|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Stiffness Score From 5 Years Postoperative to 10 Years Postoperative|"This index assesses stiffness as reported by the patient. The WOMAC stiffness scale has a minimum value of 0 (worst stiffness) to a maximum value of 100 (no stiffness).~The change score was calculated by subtracting the five-year score from the 10 year score."|5 years postoperative to 10 years postoperative||||units on a scale||Standard Deviation|Mean
2668863|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Function Score From 5 Years Postoperative to 10 Years Postoperative|"This index assesses function as reported by the patient. The WOMAC function scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).~The change score was calculated by subtracting the five year score from the 10 year score."|5 years postoperative to 10 years postoperative||||units on a scale||Standard Deviation|Mean
2668889|NCT01500096|Secondary|Change in Plasma HIV RNA|Laboratory: Change in plasma HIV RNA from baseline to week 4. A negative value means a drop in plasma HIV RNA.|From baseline to week 4 (28 days of study drugs)||||copies/mL||Standard Deviation|Mean
2668865|NCT01500252|Primary|Change in WOMAC Osteoarthritis Index Stiffness Score From Preoperative to 5 Years Postoperative|"This is the change in the patients' perceived pain between preoperative and 5 years postoperative.~The WOMAC stiffness scale has a minimum value of 0 (maximal stiffness) to a maximum value of 100 (no stiffness).~The change score was calculated by subtracting the preoperative score from the five year score."|Preoperative to 5 years postoperative|One subject in the patellar retention group missed too many responses on the WOMAC questionnaire and was not included in the analysis.|||units on a scale||Standard Deviation|Mean
2668866|NCT01500252|Primary|Change in WOMAC Osteoarthritis Index Function Score From Preoperative to 5 Years Postoperative|"This measures the change in patients' reported function from preoperative to 5 years postoperative.~The WOMAC Function scale has a minimum value of 0 (worst function) to a maximum value of 100 (no functional limitations).~The change score was calculated by subtracting the preoperative score from the five year score."|Preoperative to 5 years postoperative|One subject in the patellar retention group missed too many responses on the WOMAC questionnaire and was not included in the analysis.|||units on a scale||Standard Deviation|Mean
2668867|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Stiffness Score From Preoperative to 1 Year Postoperative|"This index assesses stiffness as reported by the patient. The WOMAC stiffness scale has a minimum value of 0 (worst stiffness) to a maximum value of 100 (no stiffness).~The change score was calculated by subtracting the preoperative score from the one year score."|Preoperative to 1 year postoperative||||units on a scale||Standard Deviation|Mean
2668868|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Function Score From Preoperative to 1-year Postoperative|"This index assesses function as reported by the patient. The WOMAC function scale has a minimum value of 0 (worst function) to a maximum value of 100 (no functional limitations).~The change score was calculated by subtracting the preoperative score from the one year score."|Preoperative to 1 year postoperative|Two subjects, one in the patellar retention group and one in the patellar resurfacing group missed too many responses on the WOMAC questionnaire and was not included in the analysis.|||units on a scale||Standard Deviation|Mean
2668869|NCT01500252|Secondary|Change in WOMAC Osteoarthritis Index Pain Score From Preoperative to 1 Year Postoperative|"This index assesses pain as reported by the patient. The WOMAC Pain scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).~The change score was calculated by subtracting the preoperative score from the one year score."|Preoperative to 1 year postoperative|Two subjects, one in the patellar retention group and one in the patellar resurfacing group missed too many responses on the WOMAC questionnaire and was not included in the analysis.|||units on a scale||Standard Deviation|Mean
2668870|NCT01500252|Primary|Change in Western Ontario MacMaster (WOMAC) Osteoarthritis Index Pain Score From Preoperative to 5 Years Postoperative|"This index assesses pain as reported by the patient. The WOMAC Pain scale has a minimum value of 0 (worst pain) to a maximum value of 100 (no pain).~The change score was calculated by subtracting the preoperative score from the five year score."|Preoperative to 5 years postoperative|One subject in the patellar retention group missed too many responses on the WOMAC questionnaire and was not included in the analysis.|||units on a scale||Standard Deviation|Mean
2668871|NCT01500226|Secondary|Overall Response Rate|To determine the effect of rolapitant on complete response rate in the overall (0 to 120 hours) phase of CINV.|0 to 120 hours|MITT|||percentage of participants||95% Confidence Interval|Number
2668872|NCT01500226|Secondary|Acute Phase Response|To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours) phase of CINV.|0 to 24 hours|MITT|||percentage of participants||95% Confidence Interval|Number
2668873|NCT01500226|Primary|No Emetic Episodes and No Rescue Medication|The primary objective of this study is to determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving MEC. The primary outcome will be based on complete response (defined as no emesis and no rescue medication) in the delayed phase (>24 to 120 hours).|>24 to 120 hours post chemotherapy|MITT|||percentage of particpants||95% Confidence Interval|Number
2668874|NCT01500213|Secondary|Overall Response Rate|To determine the effect of rolapitant on complete response rate in the overall (0 to 120 hours) phase of CINV.|0 to 120 hours|MITT|||percentage of participants||95% Confidence Interval|Number
2668875|NCT01500213|Secondary|Acute Phase Response|To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours) phase of CINV.|0 to 24 hours|MITT|||percentage of participants||95% Confidence Interval|Number
2668876|NCT01500213|Primary|No Emetic Episodes and No Rescue Medication|The primary objective of this study is to determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving HEC. The primary outcome will be based on complete response (defined as no emesis and no rescue medication) in the delayed phase (>24 to 120 hours).|>24 to 120 hours post chemotherapy|MITT|||percentage of participants||95% Confidence Interval|Number
2668877|NCT01500200|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) Total Score|"The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is at a specific point in time. Based on the scale, patients are categorized as follows: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients."|4 weeks for each stage|Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline HAM-D17 assessment in the respective stage. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 8/8 group for efficacy analysis.|||score on a scale||Standard Error|Least Squares Mean
2668890|NCT01500096|Secondary|Change in CD4 Cell Count|Laboratory: Change in absolute cluster of differentiation 4 (CD4) cell count from baseline to week 5. Negative values mean decline in CD4 cell count.|From baseline to week 5 (28 days of study drugs)||||cells per cubic millimeter||Standard Deviation|Mean
2668891|NCT01500096|Secondary|Inflammatory Markers|Laboratory - Inflammatory Markers (IMs): Change in Interleukin (IL) -6 and soluble receptors of tumor necrosis factor (TNF) α 1 and 2 (sTNFR1 and sTNFR2) from baseline to week 4. Negative values indicate less change in inflammatory markers.|From baseline to week 4 (28 days of study drugs)||||pg/ml||Standard Deviation|Mean
2668878|NCT01500200|Secondary|Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score|The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.|4 weeks for each stage|Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline HAM-D17 assessment in the respective stage. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 8/8 group for efficacy analysis.|||score on a scale||Standard Error|Least Squares Mean
2668879|NCT01500200|Secondary|Proportion of Patients Who Exhibited Treatment Response (HAM-D17)|The proportion of subjects demonstrating HAM-D17 treatment response, defined as a ≥ 50% reduction in HAM-D17 score from baseline to the end of the efficacy period (Week 4). The HAM-D17 is a clinician administered questionnaire comprised of 17 questions used to assess the severity of a patient's depression. Scores range from 0 (no apparent symptoms) to 50 (most severe symptoms). Individual questionnaire items include depressed mood, work and activities, insomnia (early), insomnia (middle), insomnia (late), genital symptoms, somatic symptoms (gastrointestinal), loss of weight, somatic symptoms (general), feelings of guilt, suicide, anxiety (psychic), anxiety (somatic), hypochondriasis, insight, agitation, and retardation.|4 weeks for each stage|Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline HAM-D17 assessment in the respective stage.|||Participants|||Count of Participants
2668880|NCT01500200|Primary|Change From Baseline to Week 4 in Hamilton Rating Scale for Depression (HAM-D17) Total Score|The HAM-D17 scale is a clinician-administered questionnaire comprised of 17 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 50 (most severe symptoms). Individual questionnaire items include depressed mood, work and activities, insomnia (early), insomnia (middle), insomnia (late), genital symptoms, somatic symptoms (gastrointestinal), loss of weight, somatic symptoms (general), feelings of guilt, suicide, anxiety (psychic), anxiety (somatic), hypochondriasis, insight, agitation, and retardation.|Baseline and 4 weeks for each stage|Stage 1 and Stage 2 Full Analysis Sets (FAS) consisted of subjects who were randomized and took at least 1 dose of study drug and had at least 1 postbaseline HAM-D17 assessment in the respective stage. Two subjects randomized to 8/8 in Stage 1 received 2/2. These subjects are included in the 8/8 group for efficacy analysis.|||score on a scale||Standard Error|Least Squares Mean
2668881|NCT01500187|Primary|DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison|Outcome of fluoride varnish or gel application to white spot lesions as measured by DIAGNOdent device after orthodontic debonding. Values shown represent the mean DIAGNOdent reading. The DIAGNOdent scale spans values from 0 to 30+ where larger values indicate higher levels of demineralization.|Baseline, Three and Six Month||||units on a scale|Teeth|Standard Deviation|Mean
2668882|NCT01500135|Secondary|Time to Intra-operative Hemostasis Within 10 Minutes at the Evaluation Site After Application of the Randomized Treatment|After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. Hemostasis was assessed at 3, 4, and 5 minutes. If hemostasis was not obtained after 5 minutes a second application of IMP was applied with 3 minutes of light pressure and hemostasis was re-assessed at 8, 9 and 10 minutes.|Within 10 minutes|FAS included all randomized participants. Participants who did not achieve hemostasis by 10 minutes were censored.|||minutes||95% Confidence Interval|Median
2668883|NCT01500135|Secondary|Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 5 Minutes After Application of the Randomized Treatment|After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. If hemostasis was not obtained at minute 3, pressure was immediately reapplied. Hemostasis was re-assessed at minutes 4 and 5.|Within 5 minutes|FAS included all randomized participants. The endpoint for one participant on TachoSil® was missing; it was assumed that hemostasis was not reached within 5 minutes.|||percentage of participants||95% Confidence Interval|Number
2668884|NCT01500135|Primary|Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 3 Minutes After Application of the Randomized Treatment|After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. The first assessment of hemostasis was at minute 3: the pressure was carefully relieved, and the area was observed for visual bleeding at the site of the IMP. If no bleeding was visible, hemostasis was obtained and recorded.|Within 3 minutes|Full Analysis Set (FAS) included all randomized participants. The endpoint for one participant on TachoSil® was missing; it was assumed that hemostasis was not reached within 3 minutes.|||percentage of participants||95% Confidence Interval|Number
2668885|NCT01500109|Secondary|Pain Scores Using the Age-appropriate Pain Scale|The investigators will also be looking for the presence of pruritus, nausea, vomiting and/or sedation|24 hours|||||||
2668886|NCT01500109|Primary|Opioid (Fentanyl and Morphine) Consumption|The primary outcome measure of the study will be to measure opioid (Fentanyl and Morphine) consumption during the intraoperative period first postoperative 24 hours (measured in morphine equivalents).|intraoperative period and first postoperative 24 hours||||mcg•kg-1||95% Confidence Interval|Mean
2668887|NCT01500096|Secondary|Number of Participants With Adverse Events in the Ginseng and Placebo Arms|Adverse events (AEs) were assessed from baseline to wk 4 using the NIH Division of AIDS (DAIDS) Grading Toxicity Table, a well known tool used by NIH networks for assessing the severity of AEs in participants enrolled in clinical trials. Reporting the number of participants in each arm who experienced adverse events.|From baseline to week 4 (28 days of study drugs)||||Participants|||Count of Participants
2668888|NCT01500096|Secondary|Change in PROMIS Fatigue|Questionnaire: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue score from baseline to week 4. Change in PROMIS fatigue score from baseline to Week 4. The change in fatigue as measured by the PROMIS fatigue (Week 4 minus Baseline) using the Wilcoxon test. The PROMIS fatigue is a scale with normalized mean of 50 and standard deviation (SD) of 10. Higher mean values mean more fatigue and negative values indicate less fatigue.|From baseline to week 4 (28 days of study drugs).|There was one missed PROMIS fatigue questionnaire in the ginseng 3000 mg arm.|||units on a scale||Standard Deviation|Mean
2668892|NCT01500096|Secondary|Changes in Clinical Global Impressions|"Questionnaire: Change in Clinical Global Impressions (CGI) scores from baseline to week 4. CGI is an instrument for making global assessments of worsening or improvement during interventional trials. The subject rates the change in the overall status since beginning the intervention (ranging from: very much improved, much improved, minimally improved, no change, and minimally worse). We assessed the number of participants who rated very much improved."|From baseline to week 4 (28 days of study drugs)||||Participants|||Count of Participants
2668893|NCT01500096|Secondary|Change in Medical Outcomes Study HIV Health Survey|Questionnaire: Change in Medical Outcomes Study (MOS) HIV Health Survey score from baseline to week 4. We evaluated the MOS Energy Fatigue scores; the MOS scale ranges from 0-100; higher scores mean more energy. The MOS was used to supplement the data obtained from the FSS.|From baseline to week 4 (28 days of study drugs)||||units on a scale||Standard Deviation|Mean
2668894|NCT01500096|Secondary|Change in Insomnia Severity Index|Questionnaire: Change in Insomnia Severity Index (ISI) score from baseline to week 4. The ISI scale ranges from 0 to 28; higher scores mean worse insomnia while negative scores indicate less insomnia. The ISI was used to supplement the data obtained from the FSS.|From baseline to week 4 (28 days of study drugs)|There was one missing ISI in the ginseng 3000 mg arm|||units on a scale||Standard Deviation|Mean
2668895|NCT01500096|Secondary|Change in Patient Health Questionnaire 9|Questionnaire: Change in Patient Health Questionnaire 9 (PHQ9) score from baseline to week 4. The scale for the PHQ9 score ranges from 0 to 27; higher scores mean worse depression; negative scores indicate less depression. We compared PHQ 9 scores from baseline to week 4 in the ginseng 1000 and 3000 mg arms with the combined placebo arms. The PHQ9 was used to supplement the data obtained from the FSS.|From baseline to week 4 (28 days of study drugs)|There was one missed PHQ9 in the ginseng 3000 mg arm|||units on a scale||Standard Deviation|Mean
2668896|NCT01500096|Secondary|Change in Epworth Sleepiness Scale|Questionnaire: Change in Epworth Sleepiness Scale (ESS) score from baseline to week 4. The ESS is scale ranges from 0 to 24; higher scores mean worse sleep disorder while a negative score indicates less sleep disorder. The ESS was used to supplement the data obtained from the FSS.|From baseline to week 4 (28 days of study drugs)|There was one missing questionnaire from the ginseng 3000 arm|||units on a scale||Standard Error|Mean
2668897|NCT01500096|Secondary|Change in the Brief Fatigue Inventory|"Questionnaire: Change in the Brief Fatigue Inventory (BFI) from baseline to week 4. We compared BFI scores from baseline to week 4 in the ginseng 1000 and 3000 mg arms with the combined placebo arms. We used the BFI Question that assess Worst Fatigue score: 0 to 90 scale. Higher scores means more fatigue; negative values mean less fatigue.The BFI was used to supplement the data obtained from the FSS."|Change in BFI scores from baseline to week 4 (28 days of study drugs)|There was on missing questionnaire from the ginseng 3000 arm|||units on a scale||Standard Deviation|Mean
2668898|NCT01500096|Primary|Change in Fatigue Severity Score (FSS)|Change in FSS score from baseline to Week 4. The change in fatigue as measured by the FSS (Week 4 minus Baseline) using the Wilcoxon test. The FSS is a scale score ranging from 1 to 63 with higher scores indicative of more fatigue. A negative number indicates a decline in the FSS scale. Participants with FSS data at both times points were assessed.|From baseline to week 4 (28 days of study drugs)|There was one missing scale from the ginseng 3000 arm|||units on a scale||Standard Deviation|Mean
2668899|NCT01500083|Primary|Number of Adverse Events||Up to 266 days|APTS|||number of adverse events|||Number
2668900|NCT01500057|Secondary|Change From Baseline to 12 Months in Post Void Residual Volume|post void residual was measured using a bladder scan device|baseline and 12 months|all participants who completed the study and have available data|||ml||Standard Deviation|Mean
2668901|NCT01500057|Primary|Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax)|maximum urinary flow rate was measures using uroflow device|baseline and 12 months|all participants who completed the study and have available data|||ml/sec||Standard Deviation|Mean
2668902|NCT01500057|Primary|Change From Baseline in American Urological Association Symptom Score|The American Urological Association Symptom Score range is 0-35 with 35 being the most severe urinary symptoms|Baseline and 12 months|All people who completed the study and had data available|||units on a scale||Standard Deviation|Mean
2668903|NCT01500031|Other Pre-specified|OffRoad System Use Length of Time|"From time of positioning balloon catheter introduced in the body until time final OffRoad component removed."|On the day of Procedure|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 1 participant was not evaluable (No data available).|||minutes||Standard Deviation|Mean
2668904|NCT01500031|Other Pre-specified|Overall Procedure Time|Defined as the time when the treating physician first punctures the skin in order to obtain access to the artery to treat the target lesion until the time the introducer sheath is removed from the body.|On the day of Procedure|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis.|||minutes||Standard Deviation|Mean
2668905|NCT01500031|Other Pre-specified|Device-related Dissection, Grade C or Greater|"Type A- Small radiolucent area within the lumen of the vessel disappearing with the passage of the contrast material.~Type B- Appearance of contrast medium parallel to the lumen of the vessel disappearing within a few cardiac cycles.~Type C- Dissection protruding outside the lumen of the vessel persisting after passage of the contrast material.~Type D- Spiral shaped filling defect with or without delayed run-off of the contrast material in the antegrade flow.~Type E- Persistent luminal filling defect with delayed run-off of the contrast material in the distal lumen."|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).|||percentage of participants|||Number
2668906|NCT01500031|Other Pre-specified|Target Lesion Revascularization Due to a Complication|Any surgical or percutaneous intervention to the target lesion(s) after the index procedure.|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).|||percentage of participants|||Number
2676101|NCT01441102|Secondary|Changes in Mean Macular Sensitivity in the Study Eye at 6 Months Compared to Baseline|Microperimetry was used to assess macular sensitivity.|Baseline and 6 Months||||dB|eyes|Standard Deviation|Mean
2668907|NCT01500031|Other Pre-specified|Acute Procedure Success|Acute Procedure Success, defined as device technical success and the absence of in-hospital Major Adverse Events {death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above)}|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).|||percentage of participants|||Number
2668908|NCT01500031|Other Pre-specified|All Adverse Events|All adverse events (AEs) reported by the centers.|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).|||adverse events|||Number
2668909|NCT01500031|Other Pre-specified|Device-related Major Amputation at Ankle Level or Above of Treated Lower Limb|"All Major amputations related to the use of the OffRoad Re-entry Catheter System.~Events are based on site reported Adverse Event data."|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).|||percentage of participants|||Number
2668910|NCT01500031|Other Pre-specified|Device-related Clinically Significant Peripheral Embolism|"All clinically significant peripheral embolisms related to the use of the OffRoad Re-entry Catheter System.~Events are based on site reported Adverse Event data."|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).|||percentage of participants|||Number
2668911|NCT01500031|Other Pre-specified|Device-related Perforation Requiring Intervention|"All perforation requiring intervention related to the use of the OffRoad Re-entry Catheter System.~Events are based on site reported Adverse Event data."|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).|||percentage of participants|||Number
2668912|NCT01500031|Other Pre-specified|Device-related Death|All death related to the use of the OffRoad Re-entry Catheter System. Events are based on site reported Adverse Event data.|30 days|All subjects who signed and dated the written Informed Consent Form and had any part of the OffRoad System introduced into the body were included in the analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day).|||percentage of participants|||Number
2668913|NCT01500031|Primary|Effectiveness (On the Day of Procedure)|Device Technical Success rate, defined as placement of a guidewire in the true lumen distal to a Chronic Total Occlusion (CTO)|Device technical success is determined during the index procedure, from the time of first puncture of the skin in order to obtain access to the artery until the time the introducer sheath is removed from the body|The primary endpoints were analyzed on an intent-to-treat (ITT) basis. All subjects who signed and dated the written Informed Consent Form (ICF) and had any part of the OffRoad System introduced into the body were included in the ITT analysis.|||percentage of participants||95% Confidence Interval|Number
2668914|NCT01500031|Primary|Composite Rate of Major Adverse Events|"Composite rate of major adverse events (MAEs) related to the OffRoad System at 30 days, including: death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation (amputation of the treated lower limb at the ankle level or above).~Events are based on data adjudicated by a Clinical Event Committee."|30 days|The primary endpoints were analyzed on an intent-to-treat (ITT) basis. All subjects who signed and dated the written Informed Consent Form (ICF) and had any part of the OffRoad System introduced into the body were included in the ITT analysis. 2 participants were not evaluable (No follow-up ≥ 23 days and events-free within 30-day)|||percentage of participants|||Number
2668915|NCT01499862|Primary|Ambulation Speed|Ambulation speed, in meters per second, as obtained by the Ten (10) Meter Walk Test (10 MWT). The 10 MWT measures the time required to walk 10 meters at the subject's comfortable walking pace.|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.|||meters per second (m/s)|||Number
2668916|NCT01499862|Secondary|Step Length|The length of the patient's average step, in meters, as measured during comfortable walking.|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.|||Meters|||Number
2668917|NCT01499862|Secondary|Five Times Sit to Stand Test (5 x STS)|The time, in seconds, for the patient to rise from a seated to full standing position and return to sitting five times in rapid succession. This evaluation is called the Five Times Sit to Stand Test (5 x STS)|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.|||Seconds|||Number
2668918|NCT01499862|Secondary|Timed Up and Go (TUG) Test|The time, in seconds, for the patient to rise from sitting in a standard arm chair, walk 3 meters, turn around, walk back to the chair, and sit down. This evaluation is called the Timed Up and Go test (TUG). The patient may wear their usual footwear and use any aids (canes, walkers, etc.) they typically employ for comfortable walking.|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.|||Seconds|||Number
2668919|NCT01499862|Secondary|6 Minute Walk Test (6 MWT)|The total distance walked by the patient, in meters, as obtained by the Six (6) Minute Walk Test (6 MWT). The 6 MWT is performed over level ground, using any walking aids (canes, walkers, etc.) the patient requires for comfortable walking.|Baseline (prior to training); at conclusion of 4 week training regimen (1.5 hours/session with 2 to 4 sessions per week); and 1 Month post-training regimen.|Three (3) Subjects all of whom had a plateaued with conventional Bodyweight-Supported Treadmill Training (BWSTT) participated in task-oriented mobility therapy (1.5 hours, 2-4 times per week for 4 weeks) with the Tibion Bionic Leg under the supervision of a physical therapist.|||Meters|||Number
2668920|NCT01499849|Secondary|Overall Response Rate|To determine the effect of rolapitant on complete response rates in the overall (0 to 120 hours) phase of CINV.|0 to 120 hours|MITT|||percentage of participants||95% Confidence Interval|Number
2668921|NCT01499849|Secondary|Acute Phase Response|To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours)phase of CINV|0 to 24 hours|MITT|||percentage of participants||95% Confidence Interval|Number
2668922|NCT01499849|Primary|No Emetic Episodes and No Rescue Medication|The primary objective of this study is to determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving HEC. The primary outcome will be based on complete response (defined as no emetic episodes and no rescue medication) in the delayed phase (>24 to 120 hours).|>24 to 120 hours post chemotherapy|MITT|||percentage of participants||95% Confidence Interval|Number
2668923|NCT01499810|Secondary|Change in Morning Surge of BP||from baseline to 6 months|||||||
2668924|NCT01499810|Secondary|Change in Morning Surge of BP||from baseline to 12 months|||||||
2668925|NCT01499810|Secondary|Change in Arterial Stiffness|Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000|from baseline to 6 months|||||||
2668926|NCT01499810|Secondary|Change in Arterial Stiffness|Change of cardio-ankle vascular index(CAVI) assessed by vascular screening device VaSera VS1000 (name of the model)|from baseline to 12 months|||||||
2668927|NCT01499810|Secondary|Change in Ultrasound Intima Media Thickness of Carotid Artery||from baseline to 12 months|||||||
2668928|NCT01499810|Secondary|Change in Ultrasound Intima Media Thickness of Carotid Artery||from baseline to 6 months|||||||
2668929|NCT01499810|Secondary|Change in Resistive Index Measured by Renal Doppler Flowmetry in Right Main Renal Artery|Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity|from baseline to 12 months||||difference between ratios||Standard Deviation|Mean
2668930|NCT01499810|Secondary|Change in Resistive Index Measured by Renal Doppler Flowmetry in Left Main Renal Artery|Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity|from baseline to 12 months||||difference between ratios||Standard Deviation|Mean
2668931|NCT01499810|Secondary|Change in Renal Resistive Index Measured by Doppler Flowmetry in Right Main Renal Artery|Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity|from baseline to 6 months||||difference between two ratios||Standard Deviation|Mean
2668932|NCT01499810|Secondary|Change in Renal Resistive Index Measured by Doppler Flowmetry in Left Main Renal Artery|Resistive index calculated as relative difference between assessed by ultrasound Doppler maximal and minimal blood flow velocities, i.e. absolute difference between maximal and minimal blood flow velocities divided by maximal flow velocity|from baseline to 6 months||||difference between two ratios||Standard Deviation|Mean
2668933|NCT01499810|Secondary|Change in Specific Gravity of Urine|Change of specific gravity of morning urine sample|from baseline to 12 months||||no specific units||Standard Deviation|Mean
2668934|NCT01499810|Secondary|Change in Specific Gravity of Urine|Change of specific gravity of morning urine sample|from baseline to 6 months||||no specific units||Standard Deviation|Mean
2668935|NCT01499810|Secondary|Change in Specific Gravity of Urine|Change of specific gravity of morning urine sample|from baseline to 1 week||||no specific units||Standard Deviation|Mean
2668936|NCT01499810|Secondary|Change in Casual Proteinuria|Change of protein concentration in morning urine sample|from baseline to 12 months||||g/l||Standard Deviation|Mean
2668937|NCT01499810|Secondary|Change in Casual Proteinuria|Change of protein concentration in morning urine sample|from baseline to 6 months||||g/l||Standard Deviation|Mean
2668938|NCT01499810|Secondary|Change in Casual Proteinuria|Change of protein concentration in morning urine sample|from baseline to 1 week||||g/l||Standard Deviation|Mean
2668939|NCT01499810|Secondary|Change in Serum Creatinine||from baseline to 12 months||||micromol/l||Standard Deviation|Mean
2668940|NCT01499810|Secondary|Change in Serum Creatinine||from baseline to 6 months||||micromol/l||Standard Deviation|Mean
2668941|NCT01499810|Secondary|Change in Serum Creatinine||from baseline to 1 week||||micromol/l||Standard Deviation|Mean
2668942|NCT01499810|Secondary|Change in Nighttime Diastolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 6 months||||mmHg||Standard Deviation|Mean
2668943|NCT01499810|Secondary|Change in Nighttime Systolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 6 months||||mmHg||Standard Deviation|Mean
2668944|NCT01499810|Secondary|Change in Daytime Diastolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 6 months||||mmHg||Standard Deviation|Mean
2668945|NCT01499810|Secondary|Change in Daytime Systolic BP Variability|daytime/nighttime BP variability is a standard deviation of BP values measured respectively during daytime/nighttime periods in course of ambulatory BP monitoring|from baseline to 6 months||||mmHg||Standard Deviation|Mean
2668971|NCT01499810|Primary|Number of Serious Adverse Events|A number of first occurrences (within the study period) of any of the following: death, end-stage renal disease, an embolic event resulting in end-organ damage, major bleeding event, renal artery thrombosis, new renal artery stenosis, other serious cardiovascular complications if their relation to the study treatment is assessed at least as possible.|from baseline to 12 months||||Events|||Number
2668972|NCT01499810|Primary|Change in Office Systolic BP||from baseline to 12 months|All patients who completed 12 month assessment according to the protocol.|||mmHg||Standard Deviation|Mean
2668973|NCT01499667|Secondary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death During Fingolimod Treatment|Adverse events were summarized by the number of patients having any adverse event overall.|Baseline to maximum of 16 weeks|The Safety Set included all randomized patients, analyzed according to the washout group most closely corresponding to the day on which they first received fingolimod|||participants|||Number
2668974|NCT01499667|Secondary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death During Washout Period|Adverse events were summarized by the number of patients having any adverse event overall.|Baseline to maximum of 16 weeks|The Safety Set included all randomized patients, analyzed according to the washout group most closely corresponding to the day on which they first received fingolimod|||participants|||Number
2668975|NCT01499667|Secondary|Cumulative Number of Gadolinium-enhancing T1 Lesions From the Last Natalizumab Infusion|Gadolinium-enhancing lesions will be measured on post-contrast T1-weighted brain MRI scans|8 weeks and 24 weeks|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization.|||Number of Gd enhanced T1 Lesions||Standard Deviation|Mean
2668976|NCT01499667|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) by Washout Group|Kurtzke's Expanded Disability Status Scale (EDSS) measures the changes in neurologic impairment, either chronic (progression over time), or acute (MS relapses). The EDSS steps range from 0 (normal) to 10 (death due to MS). Relapse severity is assessed based on severity of neurologic impairment as evaluated using the EDSS.|Baseline to week 16 and week 32|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization.|||Units on a scale||Standard Deviation|Mean
2668977|NCT01499667|Secondary|Number of Active (New or Newly Enlarging) T2 Lesions During the 24 Weeks After the Last Natalizumab Infusion (Baseline)|Lesions will be measured by MRIs and the number of active (new or newly enlarging) T2 lesions will be calculated for 24 weeks from baseline.|Baseline up to 24 weeks|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization|||Count of Active T2 Lesions||Standard Deviation|Mean
2668978|NCT01499667|Secondary|Number of Active (New or Newly Enlarging) T2 Lesions During the First 8 Weeks of Fingolimod Treatment|Lesions were measured by MRIs and the number of active (new or newly enlarging) T2 lesions was calculated for first 8 weeks of fingolimod treatment.|Number of active T2 lesions during 8 wks of fingolimod treatment|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization|||Count of Active T2 Lesions||Standard Deviation|Mean
2668979|NCT01499667|Secondary|Number of Active (New or Newly Enlarging) T2 Lesions From the Last Natalizumab Infusion (Baseline) up to the Initiation of Fingolimod Treatment|Lesions were measured by MRIs and the number of active (new or newly enlarging) T2 lesions was calculated from baseline to beginning of treatment.|8, 12 and 16 weeks (number of active T2 lesions during the washout period only)|The Full Analysis Set (FAS) included all randomized patients who had at least one recorded dose of natalizumab at the Week 0 visit, analyzed according to the washout group assigned at randomization|||Count of active T2 lesions||Standard Deviation|Mean
2668980|NCT01499667|Primary|Number of Active (New or Newly Enlarging) T2 Lesions From the Last Natalizumab Infusion (Baseline) Through 8 Weeks of Fingolimod Treatment|Active lesions were measured on brain MRI scans, performed at week 8, compared to the prior scan. The primary variable was analyzed by fitting a negative binomial regression model adjusted for washout group.|Number of active T2 lesions from last natalizumab dose through 8 weeks of fingolimod treatment|The modified Full Analysis Set (mFAS) included all patients in the Full Analysis Set who completed 8 weeks of fingolimod treatment and provided an MRI scan at this time point. The analysis of primary variable was performed on the mFAS.|||Count of Active T2 Lesions||Standard Deviation|Mean
2668981|NCT01499654|Post-Hoc|Injection and Scan Times|Time in minutes between doses of resting Tc-99m sestamibi doses and image scanning.|Baseline||||minutes||Standard Deviation|Mean
2668982|NCT01499654|Post-Hoc|Resting Full-Tracer Dose|Amount of the standard, clinically-accepted, full-dose Tc-99m sestamibi dose administered|Baseline|Entire Cohort|||millicurie||Standard Deviation|Mean
2668983|NCT01499654|Primary|Segments With Resting Perfusion Defect|Left ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The number of segments with a score of 1 or greater were summed to obtain the number of segments with a resting perfusion defect.|Baseline||||segments||Standard Deviation|Mean
2668984|NCT01499654|Secondary|Diagnostic Confidence Score|Each reconstructed image was subjectively scored by the expert readers to determine the expert reader's diagnostic confidence in scoring and interpreting the perfusion scores. The Diagnostic Confidence Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent).|Baseline||||units on a scale||Standard Deviation|Mean
2668985|NCT01499654|Secondary|Image Quality Score|Each reconstructed image was subjectively scored by the expert readers to determine the overall image quality. The Image Quality Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent).|Baseline||||units on a scale||Standard Deviation|Mean
2677033|NCT01435304|Secondary|Number of Participants With a Mortality|Patients will be followed until hospital discharge|Index admission postoperative until the time of discharge, an expected average of 7 days.||||Participants|||Count of Participants
2668986|NCT01499654|Primary|Sum Rest Score|Left ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The scores over 17 segments were summed to report the Sum Rest Score (SRS), ie. the greater the SRS, the larger the perfusion defect.|Baseline||||units on a scale||Standard Deviation|Mean
2668987|NCT01499576|Secondary|Number of Participants With Adverse Events|Number of Participants with Adverse Events. Assess kind of side effect and severity. Measured by interview with a physician, just after the procedure and 1weak later.|up to 1week after the acetic acid chromoendoscopy||||participants|||Number
2668988|NCT01499576|Secondary|Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists|"The findings of chromoendoscopy will be interpretated by two endoscoipists (read as positive or negative finding) independently.~We calculate the Kappa index of agreement for the acetic acid chromoendoscopy."|One month after the completion of the study||||Kappa index of agreement|Participants||Number
2668989|NCT01499576|Primary|Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy|Endoscopist judges the presence and the extent of gastric intestinal metaplasia during acetic acid chromoendoscopy. Endoscopist perform five endoscopic biopsies according to the protocol. The degree of agreement between the chromoendoscopy and the endoscopic biopsy is assessed as %.|3 months after the completion of the study (a pathologist reviewed all the biopsy slide)||||percentage of lesions|Participants||Number
2668990|NCT01499511|Secondary|Number of Participants Who Have Experienced a Transient Ischaemic Attack (TIA) Since the End of the ASCOT Trial||16 years|Combined together with 3. primary outcome, it was not possible to differentiate between data collected for TIAs and Non fatal stroke||||||
2668991|NCT01499511|Secondary|Number of Participants Who Have Required Renal Replacement Therapy (Dialysis or Kidney Transplant) Since the End of the ASCOT Trial|Number of participants who have required renal replacement therapy (dialysis or kidney transplant) since the end of the ASCOT trial, follow up|16 years|18 participants had missing data|||Participants|||Count of Participants
2668992|NCT01499511|Secondary|Number of Participants Who Have Undergone Coronary/Peripheral Re-vascularisation Procedures Since the End of the ASCOT Trial|Number of participants who have undergone coronary/peripheral re-vascularisation procedures since the end of the ASCOT trial, follow up|16 years|24 participants had missing data|||Participants|||Count of Participants
2668993|NCT01499511|Secondary|Number of Participants Who Have Developed Diabetes Since the End of the ASCOT Trial|Diabetes morbidity after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial|16 years|22 participants had missing data|||Participants|||Count of Participants
2668994|NCT01499511|Primary|Number of Participants With Non Fatal Stroke/TIA (Transient Ischaemic Attack)|Non fatal stroke and TIA (Transient Ischaemic Attack) morbidity after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial|16 years|18 participants had missing data|||Participants|||Count of Participants
2668995|NCT01499511|Primary|Number of Participants With Non Fatal Myocardial Infarction|Morbidity of non fatal myocardial infarction after 16 years in patients recruited into the Anglo-Scandinavian Outcomes trial with two groups|16 years|13 participants had missing data|||Participants|||Count of Participants
2668996|NCT01499511|Primary|Number of Participants Who Have Died From Cardiovascular Disease Since the End of the ASCOT Study|Number of participants who have died from cardiovascular disease since the end of the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Armstudy|16 years|Data not collected||||||
2668997|NCT01499498|Secondary|Number of Patients With Adverse Events|The number of repeated adverse events will be used to assess the safety of the drugs in combination|Day 1 - 16||||participants|||Number
2668998|NCT01499498|Primary|Boceprevir Maximum Plasma Concentration|administer BOC 800mg and single dose sildenafil 25mg with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)|Day 16||||ng/mL||95% Confidence Interval|Geometric Mean
2668999|NCT01499498|Primary|Sildenafil Maximum Plasma Concentration|administer BOC 800mg and single dose sildenafil 25mg with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)|Day 16||||ng/mL||95% Confidence Interval|Geometric Mean
2669000|NCT01499498|Primary|Boceprevir Alone Maximum Plasma Concentration|Day 10 commence BOC 800mg three times a day with food. On day 15 at steady state, subjects will attend for witnessed dosing and an intensive pharmacokinetic visit over 8 hours (samples drawn 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose)|day 10-15||||ng/mL||95% Confidence Interval|Geometric Mean
2669001|NCT01499498|Primary|Sildenafil Alone Maximum Plasma Concentration|Single dose sildenafil 25mg will be administered with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)|Day 1||||ng/mL||95% Confidence Interval|Geometric Mean
2669002|NCT01499355|Secondary|Duration of Renal Response in Participants Who Achieve Partial or Complete Renal Response at Any Time During the Study|Number of days between first visit with response to last consecutive visit with partial or complete response. Complete renal response is defined as: (1) uPCR <0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) eGFR within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of < 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR < 3.0 mg/mg if the Day 1 (Baseline) ratio was > 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 [Baseline] or serum creatinine within normal range). Estimated from the Kaplan-Meier Curve.|up to Week 52|The ITT population included all participants who were randomized and received at least 1 dose of study treatment (BIIB023 or placebo).|||days||Standard Deviation|Mean
2669030|NCT01499277|Secondary|Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set|Difference in microbiological favorable response rate at TOC in ME. Favourable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.|7 to 20 days after the last dose of study drug|Microbiologically evaluable (ME)|||Participant|||Number
2669003|NCT01499355|Secondary|Number of Participants With AEs, SAEs and AEs Leading to Study Discontinuation During the Double-Blind Period|AEs that had an onset on or after dosing of BIIB023 or placebo, or any pre-existing condition that worsened. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above.|Week 12 to Week 56|The safety population was defined as all subjects who received at least 1 dose of study treatment (including placebo or BIIB023).|||participants|||Number
2669004|NCT01499355|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Discontinuation During the Run-In Period|AEs that had an onset on or after dosing of MMF on run-in Day 1 up to the first double-blind dose, or any pre-existing condition that worsened. AE: any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also be any other medically important event that, in the opinion of the Investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above.|Day 1 to Week 12|All enrolled participants|||participants|||Number
2669005|NCT01499355|Secondary|Percentage of Participants With Active Urinary Sediment at Baseline Who Have Inactive Urinary Sediment at Week 52|Active urinary sediment is defined by 1 of the following (in the absence of a urinary tract infection or menses): > 5 red blood cell/high power field (RBC/HPF) or above the reference range for the laboratory, and > 5 white blood cell/high power field (WBC/HPF) or above the reference range for the laboratory, and presence of cellular casts (RBC or WBC). Inactive urinary sediment is defined as: < 5 RBC/HPF and < 5 WBC/HPF, or within the laboratory reference range, and no cellular casts (no RBC or WBC casts).|Baseline, Week 52|Participants with active urinary sediment at Day 1 in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. (Includes participants who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.)|||percentage of participants||90% Confidence Interval|Number
2669006|NCT01499355|Secondary|Percentage of Participants With uPCR > 3.0 mg/mg at Baseline Who Achieve uPCR <1.0 mg/mg at Week 52||Baseline (Day 1), Week 52|Participants with a uPCR > 3.0 mg/mg at Baseline in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. Includes those who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.)|||percentage of participants||90% Confidence Interval|Number
2669007|NCT01499355|Secondary|Time to Renal Response (Partial or Complete) in Participants Who Achieve Renal Response at Week 52|Onset of renal response was calculated as weeks elapsed from baseline date to first visit where renal response was achieved. Complete renal response is defined as: (1) uPCR <0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) eGFR within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of < 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR < 3.0 mg/mg if the Day 1 (Baseline) ratio was > 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 [Baseline] or serum creatinine within normal range). Estimated from the Kaplan-Meier Curve.|Baseline to Week 52|Participants in the ITT population who achieved a renal response at Week 52. The ITT population included all participants who were randomized and received at least 1 dose of study treatment (BIIB023 or placebo).|||weeks||Full Range|Median
2669008|NCT01499355|Secondary|Duration of Renal Response in Participants Who Achieve Complete Renal Response at Week 52|Duration of response was calculated as the days in between the date of Week 52 visit and the date when the participant last became complete renal responder on or before Week 52 visit. Complete renal response: (1) uPCR <0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline) (from a 24 hour urine collection); and (2) eGFR within normal range.|Week 52|Participants in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. (Includes participants who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.)|||Participants|||Count of Participants
2669009|NCT01499355|Secondary|Percentage of Participants Who Achieve Complete Renal Response at Week 52|Complete renal response is defined as uPCR < 0.5 mg/mg with ≥ 50% reduction of uPCR from Baseline (from a 24-hour urine collection) and eGFR within normal range.|Week 52|Participants in the mITT population (participants in ITT population except for those who withdrew from study due to study early termination. Includes participants who completed Week 44 infusion and Visits at Week 52/early withdrawal and Week 56/End of Study but withdrew due to study early termination.)|||percentage of participants|||Number
2669010|NCT01499355|Primary|Percentage of Participants Who Achieve a Complete or Partial Renal Response at Week 52|Complete renal response is defined as: (1) urinary protein:creatinine ratio (uPCR) < 0.5 mg/mg with ≥ 50% reduction of uPCR from Day 1 (Baseline; from a 24 hour urine collection); and (2) estimated glomerular filtration rate (eGFR) within normal range. Partial renal response is defined as: (1) ≥ 50% reduction in uPCR from Day 1 (Baseline; from a 24-hour urine collection) and, (2) with one of the following: (a) uPCR of < 1.0 mg/mg if the Day 1 (Baseline) was ≤ 3.0 mg/mg, or, (b) uPCR < 3.0 mg/mg if the Day 1 (Baseline) ratio was > 3.0 mg/mg; and stabilization of renal function (eGFR + or - 25% of Day 1 [Baseline] or serum creatinine within normal range).|Week 52|Participants in the modified intent-to-treat (mITT) population (participants in ITT population except for those who withdrew from study due to study early termination. Includes participants who completed Week 44 infusion and Visits at Week 52/Early Withdrawal and Week 56/End of Study but withdrew due to study early termination.)|||percentage of participants||90% Confidence Interval|Number
2669011|NCT01499303|Primary|Objective Response Rate|Patients were assessed using the revised response criteria for malignant lymphoma (Cheson). Patients were assessed for response, with CT and FDG-PET scans at 8 weeks, then every 12 weeks until radiological progression by clinical CT. Complete response (CR) was defined as disappearance of all target and non-target lesions in the liver and spleen and all lymph node masses regressed to normal size. Partial response (PR) was defined as ≥50% reduction in sum of the product of the diameters (SPD) for measured lymph nodes, splenic and liver lesions separately compared to baseline SPD. Objective response rate (CR + PR) analysis, exact binomial test, primary analysis.|Week 8|Full analysis set - all randomised patients|||Patients||95% Confidence Interval|Number
2669012|NCT01499290|Secondary|Plasma Concentrations for Ceftazidime and Avibactam|Blood samples were taken from all patients on Day 3 for the pharmacokinetic evaluation of ceftazidime and avibactam plasma concentrations|Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug|PK analysis set|||(NG/ML)||Full Range|Geometric Mean
2669013|NCT01499290|Secondary|Number of Patients Afebrile at Last Observation in the Clinically Evaluable Analysis Set for Patients Who Have Fever at Study Entry|Time to first defervescence was calculated for patients with a fever (>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day.|Test of Cure: 1 to 14 days after start of study drug|Clinically evaluable (CE) with fever, defined as >38ºC at study entry.|||Participants|||Number
2669014|NCT01499290|Secondary|Per-patient Microbiological Response at TOC for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set|"Microbiological responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)."|Test of Cure: 28 to 35 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants|||Number
2669015|NCT01499290|Secondary|Favorable Per-pathogen Microbiological Response for Patients Infected With Ceftazidime-resistant Pathogens in mMITT Analysis Set|The number of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|TOC: 28 to 35 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants|||Number
2669016|NCT01499290|Secondary|Clinical Response by Pathogen at TOC for Patients Infected With Ceftazidime-resistant Pathogens in Microbiological Modified Intent to Treat Analysis Set|Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|Test of Cure: 28 to 35 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants|||Number
2669017|NCT01499290|Secondary|Per-pathogen Microbiological Response at TOC in the Microbiologically Modified Intent-To-Treat Analysis Set.|The number of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.|TOC: 28 to 35 days after start of study drug.|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants|||Number
2669018|NCT01499290|Secondary|Per-patient Microbiological Response in the Microbiologically Modified Intent- To-Treat Analysis Set|"Microbiological responses as per the protocoled criteria: responses other than indeterminate were classified as favorable or unfavorable. Favorable microbiological response assessments included eradication and presumed eradication. Unfavorable microbiological response assessments included persistence, persistence with increasing minimum inhibitory concentration (MIC), and presumed persistence. Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to a surgical review panel (SRP) assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence)."|EOT: within 24 hours after last dose of study drug. TOC: 28 to 35 days after start of study drug. LFU 42 to 49 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants|||Number
2669031|NCT01499277|Secondary|Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set|Difference in microbiological favorable response rate at TOC in mMITT analysis set. Favorable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.|7 to 20 days after the last dose of study drug|Microbiologically modified-intent-to-treat (mMITT)|||Participant|||Number
2669019|NCT01499290|Secondary|Clinical Response by Visit in the Primary Population: Microbiologically Modified Intent-to-Treat (mMITT)|Complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, dDeath where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure.|EOT: within 24 hours after last dose of study drug. TOC: 28 to 35 days after start of study drug. LFU: 42 to 49 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants|||Number
2669020|NCT01499290|Secondary|Clinical Cure at TOC in the Extended Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|TOC: 28 to 35 days after start of study drug|Extended ME analysis set defined as all patients included in the CE set with at least 1 Gram negative, aerobic, pathogen in the initial/prestudy culture, regardless of susceptibility.|||Participants|||Number
2669021|NCT01499290|Secondary|Clinical Cure at TOC in the Microbiologically Evaluable Analysis Set|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|TOC: 28 to 35 days after start of study drug|ME analysis set defined as all patients included in the CE set with at least 1 Gram negative, aerobic, susceptible pathogen in the initial/prestudy culture.|||Participants|||Number
2669022|NCT01499290|Primary|Clinical Response at the TOC Visit in the Clinically Evaulable (CE) Analysis Set (Co-primary Outcome for Rest of World [ROW]).|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.|TOC: 28 to 35 days after start of study drug|The CE analysis set included all patients who met the disease definition of cIAI and met the stringent criteria for clinical evaluation described in the protocol regarding dosing, concomitant medication, evaluation, etc.|||Participants|||Number
2669023|NCT01499290|Primary|Clinical Response at the TOC Visit in the Modified Intent-To-Treat Analysis Set (Co-primary Outcome for Rest of World [ROW]).|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, dDeath where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure.|TOC: 28 to 35 days after start of study drug|The MITT analysis set included all randomized patients who met the disease definition of cIAI and who received any amount of study drug.|||Participants|||Number
2669024|NCT01499290|Primary|Clinical Response at the Test of Cure (TOC) Visit in the Microbiologically Modified Intent-To-Treat (mMITT) Analysis Set (Primary Outcome for FDA).|The number of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention is necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, death where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure. Results from two identical protocols D4280C00001 and D4280C00005 combined into a single database with agreement from FDA and EMA.|TOC: 28 to 35 days after start of study drug|The mMITT analysis set included all randomized patients who met the disease definition of cIAI and had at least 1 etiologic pathogen identified at study entry (regardless of isolate susceptibilities). Patients with a bacterial species typically not expected to respond to both study drugs were excluded.|||Participants|||Number
2669025|NCT01499277|Secondary|Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME|Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set|7 to 20 days after the last dose of study drug||||Participants|||Number
2669026|NCT01499277|Secondary|Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set|The observed difference in the early success rates at 48 to 72 hours of treatment (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Early response rate as measured by comparing the participant's signs and symptoms at the 48-72 hour visit to those recorded at study baseline.|48 to 72 hours after first dose of study drug||||Participants|||Number
2669027|NCT01499277|Secondary|Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC|The observed difference in the clinical relapse rates at LFU (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical relapse rate at LFU is measured by comparing a patient's signs and symptoms at late follow-up to those when they were cured at TOC.|21 to 42 days after the last dose of study drug||||Participants|||Number
2669028|NCT01499277|Secondary|Clinical Response at EOT in CE Analysis Set|The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline.|On day of last dose of study drug (or +1 day)||||Participants|||Number
2669029|NCT01499277|Secondary|Clinical Response at End of Treatment (EOT) in MITT Analysis Set|The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline.|On day of last dose of study drug (or + 1 day)||||Participants|||Number
2669032|NCT01499277|Primary|Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set|The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.|7 to 20 days after the last dose of study drug|Clinical evaluable (CE)|||Participant|||Number
2669033|NCT01499277|Primary|Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set|The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.|7 to 20 days after the last dose of study drug|Modified intent-to-treat (MITT)|||Participant|||Number
2669034|NCT01499199|Secondary|Number of Participants With Treatment-emergent Genotypic and Phenotypic Resistance to DTG and Other Antiretroviral Therapy (ART)|The number of participants with treatment-emergent genotypic and phenotypic resistance to integrase inhibitors (INIs), nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transctiptase inhibitors (NNRTIs), and protease inhibitors (PIs) was assessed.|Baseline through the date the last participant completed Week 96|Protocol Defined Virologic Failure (PDVF) Genotypic Population (Integrase inhibitor [IN] Results at Baseline and PDVF): The PDVF Genotypic and Phenotypic populations consisted of all participants in the ITT-E Population with available on-treatment genotypic and phenotypic resistance data, respectively, at the time of PDVF|||participants|||Number
2669035|NCT01499199|Secondary|The Numbers of Participants (Par.) With Clinical Adverse Events or Laboratory Abnormalities|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs/SAEs. Any abnormal laboratory test result (hematology, clinical chemistry, or urinalysis) or other safety assessments (e.g., electrocardiograms [ECGs], radiological scans, vital sign measurements), including those that worsen from Baseline, and were felt to be clinically significant in the medical and scientific judgment of the investigator, were recorded as AEs or SAEs. Clinically suspected cases of hypersensitivity to ABC were also SAEs.|Baseline (BL) through the date the last participant completed Week (W) 96 + the follow-up visit (if applicable)|Safety Population: all participants who received at least one dose of study medication. Participants were analyzed according to the actual treatments received. Participants were not excluded from this population as a result of changes to the background regimen.|||participants|||Number
2669036|NCT01499199|Secondary|Number of Participants With Post-Baseline HIV-1-associated Conditions, Including Recurrences|The number of participants who reported a new or recurrent Centers for Disease Control and Prevention (CDC) Class B or Class C condition was assessed from Baseline though the date the last participant completed Week 96 + the follow-up visit (if applicable). Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition.|Baseline through the date the last participant completed Week 96 + follow-up visit (if applicable)|ITT-E Population|||participants|||Number
2669037|NCT01499199|Secondary|Absolute Values and Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at Weeks 4, 12, 16, 24, 48, and 96|The absolute value for CD48+ cell count (cells per millimeters cubed [mm^3]) was assessed at Baseline, Week 4, Week 12, Week 16, Week 24, Week 48, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Weeks 4, 12, 16, 24, 48, and 96|ITT-E Population. Only those participants available at the indicated time point were assessed.|||cells/mm^3||Full Range|Median
2669038|NCT01499199|Secondary|Absolute Values and Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96|The absolute value for CD4+ cell count (cells per millimeters cubed [mm^3]) was assessed at Baseline, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96|ITT-E Population. Only those participants available at the indicated time point were assessed.|||cells/mm^3||Full Range|Median
2669039|NCT01499199|Secondary|Pearson Correlation Between CSF DTG Concentration and Absolute Values and Change From Baseline (CFB) in CSF HIV-1 RNA at Week 2, Week 16, and Overall|The Pearson Correlation Coefficient is a measure of the correlation between CSF DTG concentrations and absolute values/changes from Baseline in CSF HIV-1 RNA at Week 2 and Week 16. CSF HIV-1 RNA is measured as log10 copies per milliliter (copies/mL).|From Baseline to Week 16|CSF Pharmacodynamic Population. The overall analysis combines Week 2 and Week 16 data; thus, analysis was performed on 22 data points from 11 participants.|||Pearson Correlation Coefficient||90% Confidence Interval|Mean
2669040|NCT01499199|Secondary|Number of Participants With the Indicated Number of Copies of HIV-1 RNA in Both the CSF and Plasma at Baseline, Week 2, and Week 16|The relationship between HIV-1 RNA suppression in plasma and the CSF was measured as a comparison and as a change in the number of participants in the cross tabulation of <50 copies/mL in plasma, <50 copies/mL in CSF, >=50 copies/mL in plasma, and >=50 copies/mL in CSF at Baseline, Week 2, and Week 16.|Baseline, Week 2, and Week 16|CSF Pharmacodynamic Population. Only those participants available at the indicated time point were assessed.|||participants|||Number
2669041|NCT01499199|Secondary|Absolute Values and Change From Baseline in CSF HIV-1 RNA Levels at Week 2 and Week 16|The antiviral activity of dolutegravir in CSF over time was measured as absolute values and change from Baseline in HIV-1 RNA levels in CSF at Week 2 and Week 16. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline, Week 2, and Week 16|CSF Pharmacodynamic Population. Only those participants available at the indicated time points were assessed.|||log10 c/mL||Full Range|Median
2669042|NCT01499199|Secondary|Number of Participants With CSF HIV-1 RNA <50 Copies/Milliliter (c/mL) at Baseline, Week 2, and Week 16|The antiviral activity of dolutegravir in CSF over time was measured as the number of participants with HIV-1 RNA <50 copies/milliliter (c/mL).|Baseline, Week 2, and Week 16|CSF Pharmacodynamic Population: all participants who received DTG and underwent lumbar puncture during the study and provided CSF HIV-1 RNA data. Only those participants available at the indicated time points were assessed.|||participants|||Number
2669043|NCT01499199|Secondary|Absolute Values and Change From Baseline in Plasma Human Immunodeficiency Virus (HIV-1) Ribonucleic Acid (RNA) Levels at Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96|The plasma samples were collected at the Week 2, Week 4, Week 8, Week 12, Week 16, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, and Week 96 visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Weeks 2, 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, and 96|ITT-E Population. Only those participants available at the indicated time point were assessed.|||log10 copies/mL||Full Range|Median
2669044|NCT01499199|Secondary|Number of Participants With Plasma HIV-1 RNA <50 Copies Per Milliliter (c/mL) at Baseline and Weeks 2, 4, 8, 12, and 16|HIV-1 RNA response in plasma was measured as the number of participants with HIV-1 RNA less than 50 c/mL at Baseline, Week 2, Week 4, Week 8, Week 12, and Week 16.|Baseline; Weeks 2, 4, 8, 12, and 16|Intent -to-Treat Exposed (ITT-E) Population: all participants who received at least one dose of investigational product|||participants|||Number
2669045|NCT01499199|Primary|DTG Concentrations in CSF at Weeks 2 and Week 16|CSF is a clear, colorless bodily fluid produced in the choroid plexus of the brain. The CFS samples were collected at the Week 2 and Week 16 visits, within 1 hour of plasma PK sampling. DTG concentration in CSF were calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|CSF DTG Concentration Population: all participants receiving DTG who underwent lumbar puncture during the study and provided evaluable DTG CSF concentration data. One participant was excluded from the analysis at Week 2.|||Nanograms per milliliter (ng/mL)||Full Range|Median
2669046|NCT01499199|Primary|Plasma DTG Unbound Fraction at Week 2 and Week 16|The unbound fraction of DTG in plasma (presented as a percentage of unbound [i.e., free DTG not bound to cellular proteins] DTG plasma concentration over paired plasma total DTG concentration) was calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|Plasma DTG Concentration Population|||Percentage||Full Range|Median
2669047|NCT01499199|Primary|Unbound DTG Plasma Concentrations at Week 2 and Week 16|Unbound (free, not bound to cellular proteins) plasma DTG concentrations were calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|Plasma DTG Concentration Population|||Nanograms per milliliter (ng/mL)||Full Range|Median
2669048|NCT01499199|Primary|Total DTG Plasma Concentrations at Week 2 and Week 16|Total plasma DTG concentrations were calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|Plasma DTG Concentration Population: all participants receiving DTG who underwent PK sampling during the study and provided evaluable DTG plasma concentration data|||Micrograms per milliliter (µg/mL)||Full Range|Median
2669049|NCT01499199|Primary|The Ratio of Total and Unbound DTG Concentrations Between Cerebrospinal Fluid (CSF) and Plasma at Week 2 and Week 16|Cerebrospinal fluid (CSF) is a clear, colorless bodily fluid produced in the choroid plexus of the brain. The CFS samples were collected at the Week 2 and Week 16 visits, within 1 hour of plasma pharmacokinetic (PK) sampling. The ratio (presented as a percentage) of CSF DTG concentration over paired plasma total DTG concentration (RCSF_plasma) was calculated at the Week 2 and Week 16 visits.|Week 2 and Week 16|Plasma/CSF DTG Paired Sample Population: participants (par.) with plasma and CSF samples collected post-dose and within 1 hour of each other (one par. withdrew prior to Week 2 and did not contribute to PK assessments). One par. was excluded from the analysis at Week 2 because his/her paired samples were not collected within the specified timeframe.|||percentage||Full Range|Median
2669050|NCT01499173|Other Pre-specified|Program Satisfaction|Program satisfaction is measured by percentage of participants that completed the program who answered on the post test: very satisfied or extremely satisfied on a questionnaire about the program.|1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop||||percentage of participants|||Number
2669051|NCT01499173|Secondary|Perception of Stroke Attitude Clustered Within Churches Across Multiple Time Points|"Stroke attitude is measured by the odds ratio of participant's positive perception of calling 911 for stroke. Odds ratios measure the odds of responses, so higher odds ratios suggest greater odds of stroke attitude change in the post-test compared to pre-test. Stroke attitude questioners were: Q1) If I were to see signs of a stroke, calling 911 would be... (range extremely pleasant to very unpleasant); and Q2) If a person has signs of a stroke, calling 911 right away could be... (range very helpful to very harmful). Given that participants within each church are more alike than participants between churches and multiple time points, hierarchical models were used. Specifically, multilevel mixed-effects ordered logistic regression models with a fixed church-level intercept and a random participant level intercept were used to explore change between baseline and immediate post-test and baseline and delayed post-test stroke attitude after accounting for the participants' church."|1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test||||Odds ratio|||Number
2669052|NCT01499173|Secondary|Perception of Self-efficacy Clustered Within Churches Across Multiple Time Points|Perception of self-efficacy is measured by the odds ratios of the responses to questions of participant confidence in being able to identify and respond appropriately to a stroke. Odds ratios measure the odds of responses, so higher odds ratios suggest greater odds of positive self-efficacy change in the post-test compared to the pretest. Questions asking about self-efficacy were:1) I would be able to tell if someone is having a stroke and 2) I know what to do if I saw someone having a stroke. Given that participants within each church are more alike than participants between churches and multiple time points hierarchical models were used. Specifically, multilevel mixed-effects ordered logistic regression models with a fixed church-level intercept and a random participant level intercept were used to explore change between baseline and immediate post-test and baseline and delayed posttest self-efficacy after accounting for the participants' church.|1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test||||odds ratio|||Number
2669074|NCT01499095|Secondary|Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 basal insulin dose assessment. Missing data imputed using last observation carried forward.|||U/kg||Standard Error|Least Squares Mean
2669100|NCT01498991|Secondary|Ankle Active Motion Test|The participants will perform an active range-of-motion (ROM) task each time they are treated with the AMES device, in which they move the affected joint to several target joint angles, guided by visual feedback on a display screen on the AMES device.|Prior to each treatment session, on average 3 times a week|The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.||||||
2669053|NCT01499173|Secondary|Perception of Social Norms Clustered Within Churches Across Multiple Time Points|Perception of social norms is measured by the odds ratio of the responses to questions of participant agreement with others' influence to calling 911 if he/she were to see a stroke. Odds ratios measure the odds of responses, so higher odds ratios suggest greater odds of the positive change in social norms in the post-test compared to the pre-test. Questions: 1) Most people would call 911 if they were to see a stroke. 2) My family would want me to call 911 if I were to see a stroke. Given that participants within each church are more alike than participants between churches and the multiple time points, hierarchical models were used. Specifically, multilevel mixed-effects ordered logistic regression models with a fixed church-level intercept and a random participant level intercept were used to explore change between baseline and immediate post-test and baseline and delayed post-test social norms after accounting for the participants' church.|1 week between pretest before 1st workshop and post-test at the end of 2nd workshop and 1 month till the delayed post test||||odds ratio|||Number
2669054|NCT01499173|Secondary|Mean Change in Stroke Recognition|Stroke recognition was scored on a 0 - 9 point scale where 0 represents no correct answers regarding 9 scenarios and 9 represents perfect stroke recognition.|1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop||||units on a scale||95% Confidence Interval|Mean
2669055|NCT01499173|Secondary|Mean Change in Behavioral Intent to Call 911|The pre-test is conducted one week prior to the post-test. A higher score indicates greater behavioral intent. Behavioral intent is measured on a scale of 0 - 8, where 0 indicates no correct answers in responses to scenarios, and 8 indicates appropriate responses (calling 911 every time it is appropriate) to the scenarios presented.|1 week elapsed between a pretest before 1st workshop and post-test at the end of 2nd workshop||||units on a scale||95% Confidence Interval|Mean
2669056|NCT01499173|Primary|Completion|Number of participants who complete the intervention|1 week|descriptive|||Participants|||Count of Participants
2669057|NCT01499160|Secondary|PROGRESSION FREE SURVIVAL TUMOR ASSESSMENT|Patients treated with the combination of Letrozole and Lapatinib will provide tumor biopsy sample|From date of study entry until 4 weeks after removal from study or until death (whichever occurs first) up to 24 months.|data analysis was not conducted due to low sample (low accrual) and study closure|||Participants|||Count of Participants
2669058|NCT01499160|Primary|Clinical Benefit Rate of Patients Treated With the Combination of Letrozole and Lapatinib and Then After Progression, Treated With Everolimus, Letrozole and Lapatinib.|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.~Clinical benefit rate is defined as complete response+partial response+ stable disease. All participants will be treated with the combination of letrozole and lapatinib. Once the participant progresses on this regimen, the participant will be treated with everolimus, letrozole and lapatinib until they progress."|From date of study entry until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months|1 patient withdrew during cycle 1|||Participants|||Count of Participants
2669059|NCT01499147|Secondary|Number of Participants With Moderate to Severe (Grade 2-4) Acute Graft Versus Host Disease (GVHD).|Acute GVHD grade 2-4 was assessed in patients in the FluBU and FluMel groups up to 100 days after transplant.|Up to 100 days post-transplant (acute GVHD).||||participants|||Number
2669060|NCT01499147|Secondary|Time to ANC and Platelet Engraftment|Days to ANC or platelet engraftment|Up to 30 days post-transplant||||days to ANC and platelet engraftment||Full Range|Median
2669061|NCT01499147|Secondary|Participants With 100 Day Transplant-related Mortality.|Day 100 transplant-related mortality was measured in both groups.|Up to 100 days post-transplant.||||participants|||Number
2669062|NCT01499147|Primary|Number of Participants With Engraftment.|Median time to ANC engraftment and platelet engraftment in both groups as well as the transfusion requirements measured within 30 days after transplant.|Up to 30 days post-transplant||||participants|||Number
2669063|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change in WIQ Stairs Score|Change in stairs score as captured by the Walking Impairment Questionnaire (WIQ) stairs subscale. This scale item asks the subject to describe the degree of difficulty climbing one, two, or three flights of stairs in the past week. A flight of stairs is defined as 14 steps. A 5 point Likert scale scoring ranges from 1) No Difficulty, 2) Slight Difficulty, 3) Some Difficulty, 4) Much Difficulty, 5) Unable to Do, or 6) Didn Do for Other Reasons. The items on the subscale are weighted according to the difficulty of the task. The stairs score is determined by dividing the total weighted score by the greatest possible weighted score and multiplying by 100. Scores range from 0-100.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|"Four people in the nebivolol group and 1 person in the metoprolol group did not complete the items in the Stairs WIQ subscale therefore they were excluded from the analysis. One person in the metoprolol succinate group withdrew consent before the end of the study so they were also excluded from the final analysis."|||units on a scale||Standard Deviation|Mean
2669064|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change in WIQ Speed Score|Change in speed score as captured by the Walking Impairment Questionnaire (WIQ) speed score subscale. In the walking speed component, the degree of difficulty walking is ranked on a 0 to 4 scale where speed is assessed for each of the following speeds: at the following speeds: 1, slowly; 2, average speed; 3, quickly; or 4, running or jogging 1 block. Zero represents the inability to walk the specified speed, and 4 represents no difficulty. The items on the subscale are weighted according to the difficulty of the task. The speed score is determined by dividing the total weighted score by the greatest possible weighted score and multiplying by 100. Scores range from 0-100.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group. One patient in the nebivolol group failed to complete the items in the WIQ speed score subscale, therefore, only 8 patients were included in the analysis for this outcome.|||units on a scale||Standard Deviation|Mean
2669065|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change in WIQ Distance Score|Change in distance score as captured by the Walking Impairment Questionnaire (WIQ) distance score subscale. The degree of difficulty in the walking of specific distances is ranked on a 0 to 4 Likert scale, in which 0 represents the inability to walk the distance and 4 represents no difficulty. A Likert scale is an ordinal scale of consecutive, equidistant, numerical values (ie, 0 to 4). The distances assessed in the WIQ range from walking indoors around the home to walking 5 blocks (1500 feet). The items on the subscale are weighted according to the difficulty of walking. The distance score is determined by dividing the total weighted score by the greatest possible weighted score and multiplying by 100. Scores range from 0-100.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.|||units on a scale||Standard Deviation|Mean
2669066|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change in Buttock Pain|Change in buttock pain as captured by the Walking Impairment Questionnaire (WIQ). A 5 point Likert scale scoring ranges from 1) No Difficulty, 2) Slight Difficulty, 3) Some Difficulty, 4) Much Difficulty, and 5) Great Difficulty. The scores are determined by dividing the score by the maximum possible score and then multiplying by 100. The score ranges from 0-100 with lower scores indicating greater pain.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.|||units on a scale||Standard Deviation|Mean
2669067|NCT01499134|Secondary|Walking Impairment Questionnaire (WIQ) - Change Calf Pain|Change in calf pain as captured by the Walking Impairment Questionnaire (WIQ). A 5 point Likert scale scoring ranges from 1) No Difficulty, 2) Slight Difficulty, 3) Some Difficulty, 4) Much Difficulty, and 5) Great Difficulty. The scores are determined by dividing the score by the maximum possible score and then multiplying by 100. The score ranges from 0-100 with lower scores indicating greater pain.|Baseline WIQ is completed at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.|||units on a scale||Standard Deviation|Mean
2669068|NCT01499134|Secondary|Claudication Onset Time (COT)|Change in measurement of claudication onset time (COT). The COT is defined as the time when a patient first experienced pain walking during a treadmill test.|Baseline COT is measured at the time of enrollment and again at the final study visit at 26 weeks.|Final measurements of COT in the metoprolol succinate group excludes one subject who did not experience claudication while walking during the treadmill test, and one subject who withdrew consent prior to the end of the study, therefore, only 6 participants are included in the analysis for this group.|||seconds||Standard Deviation|Mean
2669069|NCT01499134|Secondary|Ankle-brachial Index (ABI)|Change in measurement of Ankle-brachial index (ABI). The ABI is the ratio of the blood pressure measured in the lower legs to the blood pressure measured in the arms.|Baseline ABI is measured at the time of enrollment and again at the final study visit at 26 weeks|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.|||Ankle-Brachial Index||Standard Deviation|Mean
2669070|NCT01499134|Primary|Peak Walking Time (PWT)|Change in peak walking time (PWT) is measured in seconds. The PWT is defined as when walking on a treadmill cannot continue due to maximal leg pain, resulting in the discontinuation of the treadmill test.|Baseline PWT is measured at the time of enrollment and again at the final study visit at 26 weeks.|One patient in the metoprolol succinate group withdrew consent prior to the end of the study, therefore, only 7 participants are included in the analysis for this group.|||seconds||Standard Deviation|Mean
2669071|NCT01499095|Other Pre-specified|Change in HbA1c From Month 6 to Month 9|Substudy comparing fixed dosing regimen (every 24 hours) vs. adaptive dosing regimen (every 24 +/- 3 hours) in a subset of participants randomized to HOE901-U300 and treated for 6 months. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Month 6 up to Month 9|mITT substudy population. Number of participants analyzed = participants with Month 6 and Month 9 HbA1c assessment. Analysis was planned to be performed for participants who were receiving HOE901­U300 (Adaptable dosing intervals or Fixed dosing intervals). Missing data imputed using last observation carried forward.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2669072|NCT01499095|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline to Month 12|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to Month 12|Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.|||percentage of participants|||Number
2669073|NCT01499095|Secondary|Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 DTSQ assessment. Missing data imputed using last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2669075|NCT01499095|Secondary|Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint|Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT population. Only participants from the mITT population with a value at baseline and at the specified timepoint were analyzed (represented by n=X, X in the category titles). Missing data imputed using last observation carried forward.|||mmol/L||Standard Error|Least Squares Mean
2669076|NCT01499095|Secondary|Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Month 6|mITT Population. Number of participants analyzed = participants with Month 6 FPG assessment. Missing data imputed using last observation carried forward.|||percentage of participants|||Number
2669077|NCT01499095|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment. Missing data imputed using last observation carried forward.|||mmol/L||Standard Error|Least Squares Mean
2669078|NCT01499095|Secondary|Percentage of Participants With HbA1c <7% at Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Month 6|mITT Population. Number of participants analyzed = participants with Month 6 HbA1c assessment. Missing data imputed using last observation carried forward.|||percentage of participants|||Number
2669079|NCT01499095|Secondary|Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint|Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of co-efficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 preinjection SMPG assessment.|||percentage of mean||Standard Error|Least Squares Mean
2669080|NCT01499095|Secondary|Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint|Preinjection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit. Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 preinjection SMPG assessment.|||mmol/L||Standard Error|Least Squares Mean
2669081|NCT01499095|Secondary|Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint|Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 mmol/L (70 milligram per deciliter [mg/dL]). Only measurements performed before initiation of rescue therapy were considered in the analysis.|Week 9 Up to Month 6|Modified intent­to­treat population.|||percentage of participants|||Number
2669082|NCT01499095|Primary|Change in HbA1c From Baseline to Month 6 Endpoint|Only measurements performed before initiation of rescue therapy were considered in the analysis.|Baseline, Month 6|Modified Intent-to-Treat population: all randomized participants who received at least (>=)1 dose, had baseline and >=1 post-baseline assessment of any efficacy variable, irrespective of compliance. Number of participants analyzed = participants with baseline and Week 6 HbA1c assessment. Missing data imputed using last observation carried forward.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2669083|NCT01499082|Other Pre-specified|Change in HbA1c From Month 6 to Month 9|Substudy comparing fixed dosing regimen (every 24 hours) vs. adaptive dosing regimen (every 24 +/- 3 hours) in a subset of participants randomized to HOE901-U300 and treated for 6 months.|Month 6 Up to Month 9|mITT substudy population. Number of participants analyzed = participants with Month 6 and Month 9 HbA1c assessment. Analysis was planned to be performed for participants enrolled in the substudy and who were receiving HOE901-U300 (Adaptable dosing intervals or Fixed dosing intervals).|||percentage of hemoglobin||Standard Error|Least Squares Mean
2669084|NCT01499082|Secondary|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline up to Month 12|Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of <=3.9 mmol/L [70 mg/dL]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level <=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level <=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level >3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose <=3.9 mmol/L).|Up to Month 12|Safety population: all participants randomized and exposed to at least one dose of study drug, regardless of the amount of treatment administered. In the event of participants having received treatments different from those assigned according to the randomization schedule, safety analyses were conducted according to treatment received.|||percentage of participants|||Number
2669099|NCT01498991|Secondary|Ankle Strength|The AMES device will test the affected ankle in each direction for maximum strength of voluntary contraction .|Prior to each treatment session, on average 3 times a week|The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.||||||
2669101|NCT01498991|Secondary|Gait Assessment Including Step Length and Cadence|Measured by the GAITRite system|Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).|The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.||||||
2669085|NCT01499082|Secondary|Change in Treatment Satisfaction Score Using The Diabetes Treatment Satisfaction Questionnaire (DTSQs) From Baseline to Month 6 Endpoint|DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1 and 4-8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction.|Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 DTSQ assessment. Missing data imputed using last observation carried forward.|||units on a scale||Standard Error|Least Squares Mean
2669086|NCT01499082|Secondary|Change in Daily Basal Insulin Dose From Baseline to Month 6 Endpoint||Baseline, Month 6|mITT Population. Number of participants analyzed = participants with Baseline and Month 6 basal insulin dose assessment. Missing data imputed using last observation carried forward.|||U/kg||Standard Error|Least Squares Mean
2669087|NCT01499082|Secondary|Change in 8-Point SMPG Profiles Per Time Point From Baseline to Month 6 Endpoint|Change in each time-point of 8-point SMPG profile: 03:00 hours (clock time) at night; before and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; and at bedtime.|Baseline, Month 6|mITT Population. Here, n = participants with Baseline and Month 6 8-point SMPG assessment separately for each analysed time point. Missing data imputed using last observation carried forward.|||mmol/L||Standard Error|Least Squares Mean
2669088|NCT01499082|Secondary|Percentage of Participants With FPG <5.6 mmol/L (<100 mg/dL) at Month 6 Endpoint||Month 6|mITT Population. Number of participants analyzed = participants with Month 6 FPG assessment. Missing data imputed using last observation carried forward.|||percentage of participants|||Number
2669089|NCT01499082|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Month 6 Endpoint||Baseline, Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 FPG assessment. Missing data imputed using last observation carried forward.|||mmol/L||Standard Error|Least Squares Mean
2669090|NCT01499082|Secondary|Percentage of Participants With HbA1c <7% at Month 6 Endpoint||Month 6|mITT Population. Number of participants analyzed = participants with baseline and Month 6 HbA1c assessment. Missing data imputed using last observation carried forward.|||percentage of participants|||Number
2669091|NCT01499082|Secondary|Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint|Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Variability was assessed by the mean of coefficient of variation calculated as 100 multiplied by (standard deviation/mean) over at least 3 SMPG measured during the 7 days preceding the assessment visit.|Baseline, Month 6|mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.|||percentage of mean||Standard Error|Least Squares Mean
2669092|NCT01499082|Secondary|Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint|Pre-injection SMPG was measured within 30 minutes prior to the injection of the study drug. Average was assessed by the mean of at least 3 SMPG calculated over the 7 days preceding the assessment visit.|Baseline, Month 6|mITT population. Missing data imputed using last observation carried forward. Number of participants analyzed = participants with baseline and Month 6 pre-injection SMPG assessment.|||mmol/L||Standard Error|Least Squares Mean
2669093|NCT01499082|Secondary|Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint|Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time), regardless the participant was awake or woke up because of the event. Severe hypoglycemia was an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Confirmed hypoglycemia was an event associated with plasma glucose less than or equal to (<=) 3.9 millimoles per liter (mmol/L) (70 milligram per deciliter [mg/dL]).|Week 9 Up to Month 6|Modified intent-to-treat population.|||percentage of participants|||Number
2669094|NCT01499082|Primary|Change in HbA1c From Baseline to Month 6 Endpoint||Baseline, Month 6|Modified Intent-to-Treat population: all randomized participants who received at least (>=)1 dose, had baseline and >=1 post-baseline assessment of any efficacy variable, irrespective of compliance. Number of participants analyzed = participants with baseline and Week 6 HbA1c assessment. Missing data imputed using last observation carried forward.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2669095|NCT01499043|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events by Worst Severity Grade|Adverse events (AEs) were assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0, where 1=mild, 2=moderate, 3=severe, 4=life-threatening, and 5=death related to AE.|Assessed from first dose through at least 4 weeks after the last dose.|Adverse events were assessed in the Safety Population.|||Participants|||Count of Participants
2669096|NCT01499043|Secondary|Number of Participants Reporting Treatment-Related Adverse Events by System Organ Class and Preferred Term||Assessed from first dose through at least 4 weeks after the last dose.|Adverse events were assessed in the Safety Population.|||Participants|||Count of Participants
2669097|NCT01499043|Primary|Summary of High Circulating Tumor Cell Count Number In Men With Radiographically Progressive Castration-Resistant Prostate Cancer and High Circulating Tumor Cells|"Effects of PLX3397 on CTC number in men with radiographically progressive CRPC and high CTC counts (≥10 CTCs/7.5 mL of blood using CellSearch Assay)~CTC counts were to be evaluated at the following time points: Screening, Baseline, every 4 weeks after treatment initiation, and at Safety Follow-up.~Radiographic tumor evaluation were to be performed every 8 weeks. Progression at the first reassessment required a confirmatory scan at a minimum of 6 weeks later, and treatment with study medication was to continue until the progression had been confirmed."|See measure description for time frame.|The study was discontinued and the primary outcome measure was not evaluated. Consequently, no efficacy was evaluated and only safety results are reported. Raw data collected but no efficacy analysis was performed/reported.||||||
2669098|NCT01498991|Secondary|ASIA Motor and Sensory Scores for L2-S1||Baseline (pre-treatment), Post-Treatment change from Baseline ( average 13 weeks), 3 months following completion of treatments (average 26 weeks from Baseline).|The study was not funded and, therefore, enrollment was terminated and the data were not analyzed.||||||
2669106|NCT01498978|Secondary|Correlation Between IRAE and Overall Survival.|"Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event.~The correlation between IRAEs and clinical outcomes will be evaluated using logistic regression for binary endpoints and Cox regression for the time to event outcomes. Due to sample size, regression is not feasible. Instead, correlation will be assessed by Fishers Exact test of association."|Up to 5 years|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive|||Participants|||Count of Participants
2669107|NCT01498978|Secondary|Correlation Between IRAE and Any Progression.|"Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event.~The correlation between IRAEs and clinical outcomes will be evaluated using logistic regression for binary endpoints and Cox regression for the time to event outcomes. Due to sample size, regression is not feasible. Instead, correlation will be assessed by Fishers Exact test of association."|Up to 5 years|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive|||Participants|||Count of Participants
2669108|NCT01498978|Secondary|Correlation Between IRAE and Radiographic Progression.|"Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event. Radiographic progression is progression determined by scan.~The correlation between IRAEs and clinical outcomes will be evaluated using logistic regression for binary endpoints and Cox regression for the time to event outcomes. Due to sample size, regression is not feasible. Instead, correlation will be assessed by Fishers Exact test of association."|Up to 5 years|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive|||Participants|||Count of Participants
2669109|NCT01498978|Secondary|Correlation Between IRAEs and Immune Response|"Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event.~Outcome not evaluated due to technical challenges collecting the data, and lack of budget and personnel to complete the analysis.~No data displayed because Outcome Measure has zero total participants analyzed."|Up to day 1 of course 4|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive||||||
2669110|NCT01498978|Secondary|Correlation of IRAEs With Ratio of T Regulatory Cells to T Effector Cells|"Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event.~Raw T cells data was collected, but has not been analyzed by the lab and will not be done due to constraints.~No data displayed because Outcome Measure has zero total participants analyzed."|Up to day 1 of course 4|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive||||||
2669111|NCT01498978|Secondary|Correlation Between IRAE and PSA Progression.|"Immune related adverse event (IRAE) is defined as any adverse event associated with drug exposure and consistent with an immune-mediated event. PSA (prostate-specific antigen) Progression is defined as a PSA increase of >= 25% and at least 2 ng/mL from Baseline, or Nadir PSA Achieved, confirmed by a second measurement at least three weeks later.~The correlation between IRAEs and clinical outcomes will be evaluated using logistic regression for binary endpoints and Cox regression for the time to event outcomes. Due to sample size, regression is not feasible. Instead, correlation will be assessed by Fishers Exact test of association."|Up to 5 years|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive|||Participants|||Count of Participants
2669112|NCT01498978|Secondary|Number of Patients With IRAEs|"Immune-Related Adverse Events (IRAEs) are defined as an adverse event (AE) of unknown etiology associated with drug exposure and consistent with an immune phenomenon~Tabulated for each treatment group and summarized according to major organ categories of the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0."|Up to 6 months|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive|||Participants|||Count of Participants
2669113|NCT01498978|Secondary|Time to Death From Any Cause|"Time to death is calculated from Day 1 of combination therapy to death from any cause.~Outcome is reported as median time to event determined by the Kaplan Meier method with 95% confidence interval."|Up to 5 years|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive|||days||95% Confidence Interval|Median
2669114|NCT01498978|Secondary|Time to Progression by Any Measure|"Time to progression is calculated from Day 1 of combination therapy to first evidence of progression by any measure (PSA, Measurable Disease or Clinical Progression).~Outcome is reported as median time to event determined by the Kaplan Meier method with 95% confidence interval."|Up to 5 years|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive|||days||95% Confidence Interval|Median
2669115|NCT01498978|Secondary|Time to PSA Progression|"PSA (prostate-specific antigen) progression defined as a PSA increase of >= 25% and at least 2 ng/mL from baseline or nadir PSA achieved, confirmed by a second measurement at least three weeks later~Time to PSA progression is calculated as the time from Day 1 of combination therapy to first PSA measurement of >= 25% increase and at least 2 ng/mL above the nadir and confirmed by a second measurement at least three weeks later. For subjects without a PSA decline from baseline, time to PSA progression is calculated as the time from Day 1 of combination therapy to first PSA measurement of >= 25% increase and at least 2 ng/mL increase from baseline after 12 weeks and confirmed by a second measurement at least three weeks later.~Outcome is reported as median time to event determined by the Kaplan Meier method with 95% confidence interval."|Up to 5 years|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive|||days||95% Confidence Interval|Median
2669184|NCT01498640|Secondary|Physician Global Assessment of Improvement|Physician global assessment of change (improvement) in subject's Dupuytren's contracture|30 days after last injection|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure|||participants|||Number
2669116|NCT01498978|Primary|Percentage of Patients Who Achieve an Undetectable PSA (=< 0.2 ng/ml)|"Undetectable PSA (prostate-specific antigen) defined as PSA ≤ 0.2 ng/mg after initiation of ipilimumab therapy.~Provided with the exact 95% confidence interval. PSA response as recommended by the Prostate Cancer Clinical Trials Working Group (PCWG2) definitions.~Percentage can take on values between 0% and 100%."|Up to 5 years|Intention to Treat (ITT) population -- all patients who sign the consent and are assigned to a treatment regardless of the actual drug dose the patients receive|||percentage of patients||95% Confidence Interval|Number
2669117|NCT01498952|Secondary|Phase 1b and Phase 2: Area Under Serum Concentration-time Curve From Time Zero to Day 22 (AUC0-Day22) of MEDI-573 for Cycle 1|Area under the concentration-time curve from time zero to Day 22 is reported. This outcome was not evaluated for Phase 2 as it was not launched by the sponsor due to strategic business reasons.|Cycle 1 (pre-dose; and 5 minutes, 24 hours, Day 8, and Day 15 post-dose); and Cycle 2 Day 1 (pre-dose)|Safety population included all participants who received any amount of study treatment.|||day*mcg/mL||Standard Deviation|Mean
2669118|NCT01498952|Secondary|Phase 1b and Phase 2: Maximum Observed Serum Concentration (Cmax) of MEDI-573 for Cycle 1|The Cmax is the maximum observed serum concentration of study drug. This outcome was not evaluated for Phase 2 as it was not launched by the sponsor due to strategic business reasons.|Cycle 1 (pre-dose; and 5 minutes, 24 hours, Day 8, and Day 15 post-dose); and Cycle 2 Day 1 (pre-dose)|Safety population included all participants who received any amount of study treatment.|||mcg/mL||Standard Deviation|Mean
2669119|NCT01498952|Secondary|Phase 1b and Phase 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-573 for Cycle 1|The tmax is defined as actual sampling time to reach maximum observed serum concentration of the study drug. This outcome was not evaluated for Phase 2 as it was not launched by the sponsor due to strategic business reasons.|Cycle 1 (pre-dose; and 5 minutes, 24 hours, Day 8, and Day 15 post-dose); and Cycle 2 Day 1 (pre-dose)|Safety population included all participants who received any amount of study treatment.|||Hours||Full Range|Median
2669120|NCT01498952|Secondary|Phase 2: Change in Tumor Size|Phase 2 part the study was not launched by the sponsor due to strategic business reasons. Therefore, this outcome was not evaluated.|From Day 1 until disease progression or death due to any cause, whichever occurred first (approximately 15 months)|Safety population included all participants who received any amount of study treatment.||||||
2669121|NCT01498952|Secondary|Phase 2: Progression-free Survival (PFS)|Phase 2 part of the study was not launched by the sponsor due to strategic business reasons. Therefore, this outcome was not evaluated.|From Day 1 until disease progression or death due to any cause, whichever occurred first (approximately 15 months)|Safety population included all participants who received any amount of study treatment.||||||
2669122|NCT01498952|Secondary|Phase 2: Objective Response Rate|Phase 2 part of the study was not launched by the sponsor due to strategic business reasons. Therefore, this outcome was not evaluated.|From Day 1 until disease progression or death due to any cause, whichever occurred first (approximately 15 months)|Safety population included all participants who received any amount of study treatment.||||||
2669123|NCT01498952|Secondary|Phase 2: Best Overall Tumor Response|Phase 2 part of the study was not launched by the sponsor due to strategic business reasons. Therefore, this outcome was not evaluated.|From Day 1 until disease progression or death due to any cause, whichever occurred first (approximately 15 months)|Safety population included all participants who received any amount of study treatment.||||||
2669124|NCT01498952|Secondary|Phase 1b and Phase 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI-573|Participants with positive ADA to MEDI-573 are reported in the below table. This outcome was not evaluated for Phase 2 as it was not launched by the sponsor due to strategic business reasons.|Predose on Day 1 of every treatment cycle; end of treatment; Days 30, 60 and 90 post treatment; every 3 months post treatrment till end of study (approximately 15 months)|Safety population included all participants who received any amount of study treatment.|||Participants|||Count of Participants
2669125|NCT01498952|Primary|Phase 2: Time to Progression|Phase 2 part of the study was not launched by the sponsor due to strategic business reasons. Therefore, this outcome was not evaluated.|From Day 1 until documentation of progressive disease (approximately 15 months)|Safety population included all participants who received any amount of study treatment.||||||
2669126|NCT01498952|Primary|Phase 1b: Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as TEAEs|An abnormal ECG findings that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurred first (approximately 15 months).|From the start of study treatment (Day 1) through 60 days after the last dose of MEDI-573 or initiation of another anticancer therapy, whichever occurred first (approximately 15 months)|Safety population included all participants who received any amount of study treatment.|||Participants|||Count of Participants
2669127|NCT01498952|Primary|Phase 1b: Number of Participants With Vital Signs Abnormalities Reported as TEAEs|An abnormal vital signs that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurred first (approximately 15 months).|From the start of study treatment (Day 1) through 60 days after the last dose of MEDI-573 or initiation of another anticancer therapy, whichever occurred first (approximately 15 months)|Safety population included all participants who received any amount of study treatment.|||Participants|||Count of Participants
2669139|NCT01498822|Secondary|Percentage of Subjects Who Achieved Seizure Freedom for 24 Consecutive Weeks During the 48 Weeks Treatment Period at Any Time|24-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom for 24 consecutive weeks during the Treatment Period at any time|From Week 2 to Week 50 (During Treatment Period )|"The Full Analysis Set (FAS) consisted of all subjects who received at least 1 (partial) dose of study mediaction and returned at least 1 post-Baseline seizure diary.~A randomized subject was only excluded from the FAS when there was clear evidence that the subject did not take any study medication."|||percentage of subjects|||Number
2669128|NCT01498952|Primary|Phase 1b: Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurred first (approximately 15 months).|From the start of study treatment (Day 1) through 60 days after the last dose of MEDI-573 or initiation of another anticancer therapy, whichever occurred first (approximately 15 months)|Safety population included all participants who received any amount of study treatment.|||Participants|||Count of Participants
2669129|NCT01498952|Primary|Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)|An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurred first (approximately 15 months).|From the start of study treatment (Day 1) through 60 days after the last dose of MEDI-573 or initiation of another anticancer therapy, whichever occurred first (approximately 15 months)|Safety population included all participants who received any amount of study treatment.|||Participants|||Count of Participants
2669130|NCT01498952|Primary|Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs)|The DLT was defined as any Grade 3 or higher hematologic or non-hematologic toxicity considered to be related to MEDI-573 that occurred during the DLT evaluation period (Days 1 to 21 of Cycle 1), with the exceptions of Grade 3 fever (occurred in the absence of neutropenia and resolved to normal or baseline within 24 hours of treatment and was not considered as SAE), Grade 3 rigors/chills that responded to optimal therapy, and Grade < 4 hyperglycemia that resolved in < 24 hours.|Day 1 to Day 21 of Cycle 1|Evaluable population included all participants enrolled in the Phase 1b who received at least 1 full dose of MEDI-573, received sorafenib treatment per standard practice during the DLT evaluation period, and completed safety follow-up through the DLT evaluation period or experienced any DLTs during the DLT evaluation period.|||Participants|||Count of Participants
2669131|NCT01498887|Secondary|Mean Number of T2 Active Lesions|The mean number of new or enlarged T2 active lesions was assessed by MRI.|12 months|Participants from the ITT population with 12 month T2 lesion numbers were analyzed. The ITT consisted of all participants included in the safety population who met the inclusion/exclusion criteria and had at least one primary endpoint (ARR) measurement recorded.|||T2 lesions||Standard Deviation|Mean
2669132|NCT01498887|Secondary|Percentage of Relapse-free Participants|Relapse-free participants were defined as participants who experienced no new neurological symptom or worsening of an existing one (relapses) during the 12-month treatment period with 0.5 mg fingolimod.|12 months|The ITT population was analyzed. The ITT consisted of all participants included in the safety population who met the inclusion/exclusion criteria and had at least one primary endpoint (ARR) measurement recorded.|||Percent|||Number
2669133|NCT01498887|Secondary|Percentage of Participants With Mild, Moderate or Severe Relapse|The investigator classified a relapse as moderate-severe if oral or intravenous (IV) treatment (according to the local clinical practice) with steroids and/or hospitalization was needed. If neither oral nor IV treatment with steroids nor hospitalization was needed, the relapse was considered as mild.|12 months|Only participants from the ITT population with severity values were analyzed. The ITT consisted of all participants included in the safety population who met the inclusion/exclusion criteria and had at least one primary endpoint (ARR) measurement recorded.|||Percentage of participants|||Number
2669134|NCT01498887|Secondary|Change From Baseline in Cerebral Volume|Cerebral volume was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement.|baseline, 12 months|Participants from the ITT population with both baseline and 12 month values were analyzed. The ITT consisted of all participants included in the safety population who met the inclusion/exclusion criteria and had at least one primary endpoint (ARR) measurement recorded.|||Percent change||95% Confidence Interval|Mean
2669135|NCT01498887|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS) Score|The EDSS is an ordinal clinical rating scale ranging from a total score of 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. A negative change from baseline indicates improvement.|baseline, 12 months|Participants from the ITT population with both baseline and 12 month values were analyzed. The ITT consisted of all participants included in the safety population who met the inclusion/exclusion criteria and had at least one primary endpoint (ARR) measurement recorded.|||score on a scale||Standard Deviation|Mean
2669136|NCT01498887|Secondary|Time to First Relapse|Time to first relapse was defined as the time from the first day of treatment to the first day of a new neurological symptom or worsening of an existing one.|first day of treatment to the first day of a new neurological symptom or worsening of an existing one, up to 12 months|The ITT population was analyzed. The ITT consisted of all participants included in the safety population who met the inclusion/exclusion criteria and had at least one primary endpoint (ARR) measurement recorded.|||months||95% Confidence Interval|Median
2669137|NCT01498887|Primary|Annual Relapse Rate (ARR)|ARR = 365 days * number of relapses / total days taking the study medication.|12 months|The ITT population was analyzed. The ITT consisted of all participants included in the safety population who met the inclusion/exclusion criteria and had at least one primary endpoint (ARR) measurement recorded.|||Relapses per year||Standard Deviation|Mean
2669138|NCT01498822|Secondary|Percentage of Subjects Who Achieved Seizure Freedom During the 48 Weeks Treatment Period|48-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom during the Treatment Period|From Week 2 to Week 50 (During Treatment Period )|"The Full Analysis Set (FAS) consisted of all subjects who received at least 1 (partial) dose of study mediaction and returned at least 1 post-Baseline seizure diary.~A randomized subject was only excluded from the FAS when there was clear evidence that the subject did not take any study medication."|||percentage of subjects|||Number
2669140|NCT01498822|Secondary|Time to the First Seizure Defined as the Time From the First Dose of Medication to the Occurrence of the First Seizure During the 48 Weeks Treatment Period||From Week 2 to Week 50 (During Treatment Period )|"The Full Analysis Set (FAS) consisted of all subjects who received at least 1 (partial) dose of study mediaction and returned at least 1 post-Baseline seizure diary.~A randomized subject was only excluded from the FAS when there was clear evidence that the subject did not take any study medication."|||months||Full Range|Median
2669141|NCT01498822|Primary|Percentage of Subjects With a Treatment Failure|Treatment failure is defined as (1) Dropout due to related intolerable adverse event, lack of efficacy or need for addition of another Antiepileptic Drug (AED), or (2) need of a 1-step down-Titration, within 50 weeks from the first dose of study medication.|Week 0 (First Dose) to Week 50|Per Protocol Set (PPS) consisted of all subjects who received at least 1 (partial) dose of study mediaction, returned at least 1 post-Baseline seizure diary and had no important protocol deviations. Subjects who discontinued the study before Week 50 for any reason other than treatment failure were excluded from the PPS.|||percentage of subjects|||Number
2669142|NCT01498744|Secondary|Complication to Antibiotic Regime||Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op|Only participants that had data collected for this outcome measure are included above.|||participants|||Number
2669143|NCT01498744|Secondary|Additional Skin or Soft Tissue Infections in Household Contacts||Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op|Only participants that had data collected for this outcome measure are included above.|||participants|||Number
2669144|NCT01498744|Secondary|Additional Skin and Soft Tissue Infections in Patient|The outcome measure was reported by responding to a yes/no|Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op|Only participants that had data collected for this outcome measure are included here.|||participants|||Number
2669145|NCT01498744|Primary|Clinical Resolution of Skin Abscess at Routine Follow-up Visit 10-14 Days Post Operation.||At office visit 10-14 days post operation|Only participants that had data collected for this outcome measure are included above.|||participants|||Number
2669146|NCT01498692|Secondary|Clinical Procedural Success|Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital MI, TVR, or cardiac death.|Duration of Hospital Stay (average 1-2 days)|Analysis was intention to treat|||percentage of participants|||Number
2669147|NCT01498692|Secondary|Acute Technical Success|Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent|During the index procedure (minutes)|Analysis was intention to treat|||percentage of stents|stents||Number
2669148|NCT01498692|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|>30 days-1 year|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with ST|||Number
2669149|NCT01498692|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|>24 hr-30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with ST|||Number
2669150|NCT01498692|Secondary|Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC)Definition|DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)|24 hours|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with ST|||Number
2669151|NCT01498692|Secondary|Target Vessel Revascularization (TVR)|Any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with TVR|||Number
2669152|NCT01498692|Secondary|Target Vessel Revascularization (TVR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with TVR|||Number
2669153|NCT01498692|Secondary|Target Vessel Revascularization (TVR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with TVR|||Number
2669154|NCT01498692|Secondary|Target Lesion Revascularization TLR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with TLR|||Number
2669155|NCT01498692|Secondary|Target Lesion Revascularization (TLR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with TLR|||Number
2669156|NCT01498692|Secondary|Target Lesion Revascularization (TLR)|Defined as any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with TLR|||Number
2669157|NCT01498692|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2669158|NCT01498692|Secondary|Cardiac Death Related to the Target Vessel|Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2669159|NCT01498692|Secondary|Cardiac Death Related to the Target Vessel|Defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above.|12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2669160|NCT01498692|Secondary|All Cause Mortality||30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2669161|NCT01498692|Secondary|All Cause Mortality||6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2669162|NCT01498692|Secondary|All Cause Mortality||12 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2669163|NCT01498692|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|30 days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with MI|||Number
2669164|NCT01498692|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|6 months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with MI|||Number
2669165|NCT01498692|Secondary|Myocardial Infarction (MI) Related to the Target Vessel|New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN|12 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants with MI|||Number
2669183|NCT01498640|Secondary|Subject Global Assessment of Satisfaction|Subject global assessment of overall treatment satisfaction|30 days after last injection|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure|||participants|||Number
2669166|NCT01498692|Secondary|Target Vessel Failure (TVF)|Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI;Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|30 Days|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2669167|NCT01498692|Secondary|Target Vessel Failure (TVF)|Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI;Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|6 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2669168|NCT01498692|Secondary|Target Vessel Failure (TVF)|Target vessel failure (TVF) is defined as any ischemia-driven revascularization of the target vessel, myocardial infarction (MI;Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|12 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2669169|NCT01498692|Secondary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.|30 Days|Analysis was intention to treat; all participants underwent clinical follow-up to provide the information needed for this endpoint.|||percentage of participants|||Number
2669170|NCT01498692|Secondary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.|6 Months|Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.|||percentage of participants|||Number
2669171|NCT01498692|Primary|Target Lesion Failure (TLF)|Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. The primary analysis set for the non-inferiority testing of the primary endpoint is the per-protocol analysis set. All randomized participants who received their assigned treatment are included in the per-protocol analysis set.|12 Months|The primary analysis set for comparison of the primary endpoint, 12-month TLF, to the predefined performance goal of 21.1% (based on historical TAXUS Express results) is the per-protocol analysis set. All enrolled participants who received a PROMUS Element stent are included in the per-protocol analysis set.|||percentage of participants|||Number
2669172|NCT01498679|Secondary|Change From Baseline in Total Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12|"The AQLQ is a disease-specific, self-administered quality of life questionnaire developed to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). The 32 items of the questionnaire are averaged to produce one overall quality of life score. The response format consists of a 7-point scale, where a value of 1 indicates total impairment and a value of 7 indicates no impairment. Change from Baseline was calculated as the Week 12 value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment."|Baseline and Week 12|ITT Population. Only those participants available at the indicated time point were assessed.|||Scores on a scale||Standard Error|Least Squares Mean
2669173|NCT01498679|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24- Hour (hr) Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily diary by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered as symptom free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Participants who were symptom free for 24-hour periods during the 12-week Treatment Period were assessed. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
2669174|NCT01498679|Secondary|Mean Change From Baseline in the Percentage of Rescue-free 24- Hour (hr) Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 12-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
2669175|NCT01498679|Secondary|Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. A Repeated Measures analysis adjusted for Baseline, region, sex, age, treatment, week, week by Baseline interaction, and week by treatment interaction was used.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population. Only those participants who had AM PEF data for at least 2 days in the Baseline week prior to randomization and at least 2 days after randomization and were available at the indicated time point were assessed.|||L/min||Standard Error|Least Squares Mean
2669176|NCT01498679|Primary|Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|Peak Expiratory Flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received >=1 dose of trial medication. The primary endpoint analysis only included participants who had PM PEF data for >=4 days in the BL week prior to randomization and >=4 days after randomization. Only participants available at the indicated time point were assessed.|||Liters/minute (L/min)||Standard Error|Least Squares Mean
2669177|NCT01498653|Secondary|Change From Baseline in Total Asthma Quality of Life Questionnaire (AQLQ) Score at Week 12|"The AQLQ is a disease-specific, self-administered quality of life questionnaire developed to evaluate the impact of asthma treatments on the quality of life of asthma sufferers. The AQLQ contains 32 items in 4 domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items), and environmental stimuli (4 items). The 32 items of the questionnaire are averaged to produce one overall quality of life score. The response format consists of a 7-point scale, where a value of 1 indicates total impairment and a value of 7 indicates no impairment. Change from Baseline was calculated as the Week 12 value minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment."|Baseline and Week 12|ITT Population. Only those participants available at the indicated time point were assessed.|||Scores on a scale||Standard Error|Least Squares Mean
2669178|NCT01498653|Secondary|Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 12-week Treatment Period|Asthma symptoms were recorded in a daily dairy by the participants every day in the morning and evening before taking any rescue or study medication and before PEF measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered as symptom free. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Participants who were symptom free for 24-hour periods during the 12-week Treatment Period were assessed. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population. In addition, the analysis only included participants who had symptom-free 24-hour period data for at least 2 days in the Baseline week prior to randomization and at least 2 days after randomization. Only those participants available at the indicated time point were assessed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
2669179|NCT01498653|Secondary|Mean Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods During the 12-week Treatment Period|The number of inhalations of rescue albuterol/salbutamol inhalation aerosol (medication used to relieve symptoms immediately) used during the day and night was recorded by the participants in a daily diary. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered as rescue free. Participants who were rescue free for 24-hour periods during the 12-week Treatment Period were assessed. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline is calculated as the average value during the 12-week Treatment Period minus the value at Baseline. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population. In addition, the analysis only included participants who had rescue-free 24-hour period data for at least 2 days in the Baseline week prior to randomization and at least 2 days after randomization. Only those participants available at the indicated time point were assessed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
2669180|NCT01498653|Secondary|Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period|PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|ITT Population. In addition, the analysis only included participants who had PM PEF data for at least 2 days in the Baseline week prior to randomization and at least 2 days after randomization. Only those participants available at the indicated time point were assessed.|||L/min||Standard Error|Least Squares Mean
2669181|NCT01498653|Primary|Mean Change From Baseline (BL) in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|Peak Expiratory Flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. The Baseline value was derived from the last 7 days of the daily diary prior to the randomization of the participant. Change from Baseline was calculated as the value of the averaged daily PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using Analysis of Covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment.|Baseline and Weeks 1-12 (up to Day 84)|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received >=1 dose of trial medication. The primary endpoint analysis only included participants who had PM PEF data for >=4 days in the BL week prior to randomization and >=4 days after randomization. Only participants available at the indicated time point were assessed.|||Liters/minute (L/min)||Standard Error|Least Squares Mean
2669182|NCT01498640|Secondary|Recurrence of Contracture|Recurrence of contracture in the joint at day 365 that was successfully treated 30 days after last injection assessed. Recurrence was defined as 20 degree or greater increase of contracture of the treated joint at day 365 or medication intervention of the treated joint between the 2 time points.|Day 365|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure; only joints that were successfully treated (reduction in contracture to 5 degrees or less) 30 days after last injection were assessed|||joints|Joints||Number
2669185|NCT01498640|Primary|Change in Range of Motion|Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees|Baseline and 30 days after last injection|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure|||degrees||Standard Deviation|Mean
2669186|NCT01498640|Primary|Percent Change From Baseline in Degree of Contracture|Change in fixed-flection contracture measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees|Baseline and 30 days after last injection|Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure|||percentage of contracture change||Standard Deviation|Mean
2669187|NCT01498640|Primary|Clinical Success|Clinical success defined as reduction in fixed-flexion contracture to less than or equal to 5 degrees 30 days after the last injection of AA4500|30 days after last injection|Efficacy assessment based on modified intent-to-treat (mITT) population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure|||percentage of particpants||95% Confidence Interval|Number
2669188|NCT01498601|Primary|Hospital Acquired Pneumonia Occurrences|Hospital acquired pneumonia is acquired greater than 48 hours after admission and is diagnosed by a positive chest x-ray plus 2 of the following 3 symptoms: presence of fever, elevated serum white blood cells count, and positive sputum specimen.|10 months||||participants|||Number
2669189|NCT01498588|Secondary|Toxicity of Chemotherapy Regimen (Number of Participants With Any Adverse Events)|Toxicity of chemotherapy at each physician visit using Common Toxicity Criteria for Adverse Effects (CTCAE) criteria.|Through 20 weeks of chemotherapy||||participants|||Number
2669190|NCT01498588|Primary|Pathologic Complete Response Rate at the Time of Surgery|Patients will receive treatment for 20 weeks with primary outcome measured at the time of surgery. Surgery is typically 4-6 weeks after completion of chemotherapy, so patients will be on study for 24 weeks on average. Response was measured by pathologist's standard of care assessment of extent of residual disease. If the patient had no evidence of invasive or in situ residual disease present in the breast and lymph node (i.e. ypT0N0), then this was defined as a pathologic complete response (pCR). Reported is the number of participants showing pCR.|Average of 24 weeks|Pathology information at the time of definitive resection was available for six of seven patients. One patient was ultimately lost to follow-up.|||participants|||Number
2669191|NCT01498575|Primary|Late Driving Performance in On-road Assessment (ODA) Test|The primary outcome was driving performance as measured by the teens completion of the standardized and validated ODA 24 weeks after enrollment. Certified professional driving evaluators blinded to randomization status terminated the ODA if they determined that the teen could not safely complete it. Criteria for termination included: (1) a driver action or inaction requiring evaluator intervention to prevent a collision; (2) a driving task requiring assistance from the evaluator to be performed safely; (3) violation of a traffic law; (4) evasive action needed by another vehicle or a pedestrian to avoid a collision; or (5) a subjective assessment by the evaluator that the teenager could not continue safely. We examined the teens ability to complete the ODA as measured by the number of terminations.|24 weeks after enrollment|512 teen-parent dyads were eligible and agreed to participate. Of these, 217 teens were scheduled to complete the ODA (128 were randomized to Teen Driving Plan (TDP), 89 to Usual Practice). Participant attrition over the time of the study resulted in 151 teens (86 TDP and 65 control) completing the 24-week ODA.|||Participants|||Number
2669192|NCT01498549|Primary|Rapid Visual Information Processing: Mean Correct Response Latency|"Cognitive Test to determine the speed of Visual information. The CANTAB Rapid Visual Information Processing test (RVP) is a measure of sustained attention with a small working memory component (Sahakian and Owen, 1992). Digits are rapidly (100/minute) and pseudo-randomly presented for 7 minutes. Subjects are instructed to press when the third digit of a target sequence (e.g. 3-5-7) is displayed. Primary outcomes are indices of target discriminability (A') and response bias (B) and response latency to targets."|2 years|Participants that completed any arm in the crossover are included in the analysis, participants with valid observations at both indices are included in the calculation.|||milliseconds||Standard Deviation|Mean
2669193|NCT01498549|Primary|Rapid Visual Information Processing|"Cognitive Test to determine the speed of Visual information. The CANTAB Rapid Visual Information Processing test (RVP) is a measure of sustained attention with a small working memory component (Sahakian and Owen, 1992). Digits are rapidly (100/minute) and pseudo-randomly presented for 7 minutes. Subjects are instructed to press when the third digit of a target sequence (e.g. 3-5-7) is displayed. Primary outcomes are indices of target discriminability (A') and response bias (B) and response latency to targets."|2 years|Participants that completed any arm in the crossover are included in the analysis.|||Proportion of Participants||Standard Deviation|Mean
2669194|NCT01498458|Secondary|Clinical Benefit Rate (CBR)|To determine the clinical benefit rate (CBR) in patients with measurable disease. CBR consists of complete response , partial response, and stable disease lasting greater than 24 weeks. All patients are included when determining this rate. 2 patients were on study treatment for a long time.Hence the outcome rate of 25 percent ( 2 from 8 patients)|3 years|All patients are included when determining this rate.|||percentage of participants|||Number
2669195|NCT01498458|Secondary|Objective Response Rate (ORR)|To determine the objective response rate (ORR) in patients with measurable disease. ORR consists of complete response and partial response according to the RECIST criteria. Complete Response refers to the disappearance of all target lesions. Any pathological lymph nodes must have a reduction in short axis to less than 10 mm. Partial Response refers to an at least 30 percent decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|3 years|All patients are included when determining this rate.|||percentage of participants|||Number
2669196|NCT01498458|Secondary|Other Toxicity of the Combination of Pazopanib and Capecitabine||3 years|6 patients experience 6 Serious Adverse Reactions|||participants|||Number
2669197|NCT01498458|Secondary|Hematological Toxicity of the Combination of Pazopanib and Capecitabine||3 years||||Number of cycles|||Number
2669198|NCT01498458|Secondary|Dose-limiting Toxicity (DLT)||3 years||||participants|||Number
2669199|NCT01498458|Primary|Maximum Tolerable Dose (MTD) of Pazopanib|The maximum tolerated dose (MTD) is defined as the highest dose level with DLT in no more than 1 out of 6 patients. A maximal tolerated dose (MTD) could not be established.|3 years||||mg|||Number
2669200|NCT01498419|Secondary|Percentage of Patients With Sputum Culture Conversion at 8 Weeks on Liquid Media|Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB. This was measured at visit 24(Day 57).|Day 57 after eight weeks of daily treatment|The efficacy analysis population contained participants included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. Participants included in this outcome had a valid, non-contaminated culture from the sample acquired on Day 57.|||percentage of patients|||Number
2669201|NCT01498419|Secondary|Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Solid Media|Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB|8 weeks|The efficacy analysis population contained patients included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants analyzed for this outcome was 206.|||days||Inter-Quartile Range|Median
2669202|NCT01498419|Secondary|Percentage of Participants Who Discontinue Due to an Adverse Event in Each Experimental Arm.||8 weeks|The Safety population was analyzed for this outcome.|||percentage of participants|||Number
2669203|NCT01498419|Secondary|The Rate of Change in Time to Sputum Culture Positivity (TTP) Through 8 Weeks in the MGIT System in Sputum Over 8 Weeks in Participants as Derived From a Non-linear Regression Model.|Measurement of TTP in liquid culture media Mycobacteria growth indicator tube (MGIT) using standard procedures|8 weeks|The efficacy analysis population contained patients included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants analyzed for this outcome was 179.|||log10hours/day||95% Confidence Interval|Mean
2669204|NCT01498419|Secondary|Percentage of Patients With Sputum Culture Conversion at 8 Weeks on Solid Media|Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB. (Day 57)|Day 57 after eight weeks of daily treatment|The efficacy analysis population contained participants included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. Participants included in this outcome had a valid, non-contaminated culture from the sample acquired on Day 57.|||percentage of participants|||Number
2669205|NCT01498419|Secondary|Time to Sputum Conversion Using Data From Weekly Cultures Through 8 Weeks on Liquid Media|liquid culture = Mycobacteria growth indicator tube (MGIT) Sputum culture conversion is defined as a change from a positive growth of M. tuberculosis in a sputum sample to negative M. tuberculosis growth sputum sample in patients with pulmonary TB|8 weeks|The efficacy analysis population contained participants included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants included for this outcome was 206.|||days||Inter-Quartile Range|Median
2669206|NCT01498419|Primary|The Rate of Change in Colony Forming Units (CFUs) Using Non-linear Mixed Effects Modeling of the Serial Sputum Colony Counts (SSCC) Over 8 Weeks of Treatment.|The primary efficacy endpoint was bactericidal activity characterized by the daily rate of change in mean log10CFU counts during 8 weeks of treatment (bactericidal activity assessed by CFU on solid media for days 0-56).|8 weeks|The efficacy analysis population contained patients included in the safety analysis population for whom efficacy data were available and who had no major protocol violations that could affect the integrity of the efficacy data. The number of participants analyzed for this outcome was 173.|||log10CFU/ml/day||95% Confidence Interval|Mean
2669207|NCT01498289|Secondary|Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs|Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Duration of treatment and follow up until death or 3 years post registration|Participants who received at least one dose of protocol treatment and were thus eligible for AE assessment|||Participants|||Number
2669208|NCT01498289|Secondary|PFS Variation by ERCC1|"Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.~Participants were divided into subgroups according to ERCC1 quartiles to assess whether the differences in PFS between the two treatment arms varied by ERCC1 levels."|up to 3 years after registration|Eligible and analyzable participants were divided into quartiles based on ERCC1 levels.|||months||95% Confidence Interval|Median
2669209|NCT01498289|Secondary|Overall Response Rate (ORR)|"ORR (complete response, unconfirmed complete response, partial response, unconfirmed partial response) in patients with measurable disease were assessed in each arm and compared between arms using Chi-squared test.~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|Up to 3 years after registration|Participants with measurable disease|||percentage of evaluable participants||95% Confidence Interval|Number
2669210|NCT01498289|Primary|Overall Survival (OS)|OS is the length of time between protocol registration and patient death|Up to 3 years after registration|Eligible and analyzable participants|||months||95% Confidence Interval|Median
2669211|NCT01498289|Primary|PFS in Low-ERCC1 Participants|Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.|Up to 3 years after registration|Eligible and analyzable participants with ERCC1 level < 1.7|||months||95% Confidence Interval|Median
2669212|NCT01498289|Primary|Progression-free Survival (PFS) in High-ERCC1 Patients|Progression-free survival is the length of time between protocol registration and disease progression or death, whichever occurs first.|Up to 3 years after registration|Eligible and analyzable participants with ERCC1 level >= 1.7|||months||95% Confidence Interval|Median
2669251|NCT01497613|Secondary|Changes in Technology Proficiency Measured by Technology Proficiency Scale|Measures the level of technology proficiency from baseline to 6th month follow-up. Higher scores means more computer proficiency. Range (6-30)|baseline and 6 months|Some participants did not complete the questionnaire. 148 participants from PRISM B and 147 from PRISM C contributed to at least one of the two time points.|||units on a scale||Standard Deviation|Mean
2669213|NCT01498185|Secondary|Pharmacokinetic Parameters on Day 7 - Ratio of Metabolite (RM) to Parent AUC[TAU]|"Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (<LLOQ) were set as missing for the calculation of PK parameters as well as summary statistics. MR was calculated as the ratio of metabolite to parent AUC(TAU), corrected for molecular weights of dapagliflozin and dapagliflozin 3-O-glucuronide (408.82 and 584.99, respectively)."|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles|||(ng*h/mL):(ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2669214|NCT01498185|Secondary|Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])|"Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (<LLOQ) were set as missing for the calculation of PK parameters as well as summary statistics. AUC[TAU], was calculated by a mixture of logand linear-trapezoidal summations."|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2669215|NCT01498185|Secondary|Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Tmax was recorded directly from experimental observations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles|||hour||Full Range|Mean
2669216|NCT01498185|Secondary|Dapagliflozin 3-O-glucuronide Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Cmax was recorded directly from experimental observations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2669217|NCT01498185|Secondary|Dapagliflozin Pharmacokinetic Parameters on Day 7 - Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])|"Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The concentrations below the lower limit of quantitation (<LLOQ) were set as missing for the calculation of PK parameters as well as summary statistics. AUC[TAU], was calculated by a mixture of logand linear-trapezoidal summations."|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2669218|NCT01498185|Secondary|Dapagliflozin Pharmacokinetic Parameters on Day 7 - Time of Maximum Observed Plasma Concentration (Tmax)|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Tmax was recorded directly from experimental observations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles|||hour||Full Range|Mean
2669219|NCT01498185|Secondary|Dapagliflozin Pharmacokinetic Parameters on Day 7 - Maximum Observed Plasma Concentration (Cmax)|Serial blood samples were collected predose 0 hr, and hr 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 in the double-blind period. Individual subject PK parameter values were derived by non-compartmental methods by a validated PK analysis program, Kinetica®. Actual sampling times were used for PK calculations and nominal times were used for generation of mean plasma concentration-time plots and summaries. Pre-dose sample collection times were changed from negative numbers (based on elapsed time to dose) to zero for the purpose of calculating PK parameters. The Cmax was recorded directly from experimental observations.|Day 7 (0 hr to 24 hr post dose)|Randomized subjects who took at least one dose of dapagliflozin with adequate pharmacokinetic parameter profiles|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2669252|NCT01497613|Secondary|Change in Computer Comfort Measured by Computer Attitude - Comfort Subscale .|Use the computer attitude scale to measure the level of computer comfort from baseline to 6th month follow-up. Higher score means more computer comfort. Range (5-25).|baseline and 6 months|Some participants did not complete the questionnaire. 148 participants from PRISM B and 149 from PRISM C contributed to at least one of the two time points.|||units in scale||Standard Deviation|Mean
2669220|NCT01498185|Primary|Mean Change From Baseline in 7-Point Glucose Monitoring (7-PGM) at Day 7|7-PGM was measured as milligrams per deciliter (mg/dL) by a central laboratory. Baseline was defined as the assessment on Day -1, prior to the start date and time of the first dose of the double-blind study medication. 7-PGM included the average of all available glucose values before and 2-hour (hr) after each meal (breakfast, lunch, dinner) as well as bedtime. Measurements were on Day -1, and Day 7 in the double-blind period.|From Baseline to Day 7|All randomized participants who received study medication and had nonmissing values at baseline and Day 7|||mg/dL||Standard Error|Mean
2669221|NCT01498120|Primary|Number of Subjects With At Least One Adverse Event (AE) From Visit 1 (Day 1) to End of Study|An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|From Visit 1 (Day 1) through End of Study (approximately 2 years)|All enrolled subjects who received at least 1 dose of study medication were included in the SS.|||subjects|||Number
2669222|NCT01498120|Primary|Number of Subjects Withdrawn Due to An Adverse Event (AE) From Visit 1 (Day 1) Through End of Study|An Adverse Event is any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.|Visit 1 (Day 1) through End of Study (approximately 2 years)|All enrolled subjects who received at least 1 dose of study medication were included in the SS.|||subjects|||Number
2669223|NCT01498068|Secondary|Number of Participants in Each Specific Category of Treatment Outcome|Participants were evaluated for following 4 categories of treatment outcome;Sustained Virologic Response 12 Weeks After Last Planned Dose of Study Medication(SVR12):hepatitis C virus (HCV)ribonucleic acid (RNA)<25 IU/mL(target not detected)12 weeks after last planned dose of study medication;Relapse:HCV RNA =>25 IU/mL during follow-up period after previous HCV RNA<25 IU/mL at planned end of treatment(EOT)[Week 24 or Week 48] and participant did not achieve SVR12planned;On treatment virologic failure:meeting virologic stopping rule and/or having detectable HCV RNA at EOT with viral breakthrough(having a confirmed increase >1 log 10 in HCV RNA level from the lowest level reached or confirmed value of HCV RNA >100 IU/mL in participants whose HCV RNA has previously become <25 IU/mL during treatment).Stopping rule defined as HCV RNA value >1000 IU/mL at Week 4, 8 or 12 or detectable HCV RNA at Week 24, 32 or 40;Other:HCV RNA <25 IU/mL at actual EOT and never HCV RNA =>25 IU/mL thereafter.|From Day 1 (Baseline) up to Follow-up visit (Week 36 or Week 60)|Full analysis (FA) population: All participants who received at least one dose of the study medication.|||Participants|||Number
2669224|NCT01498068|Secondary|Number of Participants With Virologic Failure|Virologic failure is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels more than 1,000 IU/mL at Weeks 4, 8, 12, 24, 32, or 40.|Week 4, Week 8, Week 12, Week 24, Week 32, or Week 40|Full analysis (FA) population: All participants who received at least one dose of the study medication.|||Participants|||Number
2669225|NCT01498068|Secondary|Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Less Than 25 IU/mL, (Target Not Detected) at Weeks 8, 12, 24, 32, 40 and 48|The table below shows number of participants with HCV RNA Less than 25 IU/mL, (target not detected) at Weeks 8, 12, 24, 32, 40 and 48. Only 3 treatment-naive and 14 Treatment-experienced participants were assigned to receive study treatment after Week 24. Only participants still receiving Treatment were assessed at 32, 40, and 48 weeks.|Weeks 8, 12, 24, 32, 40 and 48|"Full analysis (FA) population: All participants who received at least one dose of the study medication. n signifies number of participants who were evaluable at each specified timepoint for each arm, respectively."|||Participants|||Number
2669226|NCT01498068|Secondary|Number of Participants With Rapid Virologic Response (RVR) at Week 4|A RVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Week 4|Week 4|Full analysis (FA) population: All participants who received at least one dose of the study medication.|||Participants|||Number
2669227|NCT01498068|Secondary|Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)|Changes from baseline in log10 HCV RNA levels were calculated.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 32, Week 40, and Week 48|"Full analysis (FA) population: All participants who received at least one dose of the study medication. n signifies number of participants who were evaluable at each specified timepoint for each arm, respectively."|||Log 10 IU/mL||Full Range|Median
2669228|NCT01498068|Primary|Number of Participants With Extended Rapid Virologic Response (eRVR)|A eRVR is defined as having hepatitis C virus (HCV) ribonucleic acid (RNA) less than 25 IU/mL, (target not detected) at Weeks 4 and 12 of treatment.|Week 4 and Week 12|Full analysis (FA) population: All participants who received at least one dose of the study medication.|||Participants|||Number
2669229|NCT01497938|Primary|The Event Area Under the Curve (AUC) Was Used to Demonstrate the Reduction of Nocturnal Hypoglycemia With the Low Glucose Suspend (LGS) Feature (LGS ON)|An event is identified as: LGS feature in the correct setting; CGM values <= 65 mg/dL continuously with starting time between 10pm - 8am; No evidence of patient intervention during the first 20 minutes when CGM value was <= 65 mg/dL; The rate of change before reaching sensor glucose value of <= 65 mg/dL was <= 5 mg/dl/minutes; If the time between two successive events was less than 30 minutes, they will be combined as one event; An evaluable event is defined as any event with CGM value <= 65 mg/dL of greater than 20 minutes and the LGS feature is on the correct setting; Event AUC analysis was performed based on logarithm of AUC data.|5 months||||mg/dL x min||Standard Deviation|Mean
2669230|NCT01497938|Primary|Change in A1C From Baseline to End of Study Participation|The first study objective is to demonstrate that home use of Low Glucose Suspend (LGS) is safe and is not associated with glycemic deterioration, as measured by change in A1C from baseline to end of study participation.|5 months||||Percent||Standard Deviation|Mean
2669231|NCT01497899|Secondary|Change From Baseline in CD4+ Cell Count at Weeks 24 and 48||Baseline; Weeks 24 and 48|Participants in Full Analysis Set with available data were analyzed.|||cells/uL||Standard Deviation|Mean
2669232|NCT01497899|Secondary|Change From Baseline in log10 HIV-1 RNA at Weeks 24 and 48||Baseline; Weeks 24 and 48|Participants in Full Analysis Set with available data were analyzed.|||log10 copies/mL||Standard Deviation|Mean
2669233|NCT01497899|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 48|Full Analysis Set|||percentage of participants|||Number
2669234|NCT01497899|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24|The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.|Week 24|Full Analysis Set: participants randomized to the Double-Blind Phase and received at least 1 dose of study drug.|||percentage of participants|||Number
2669235|NCT01497860|Primary|Progression-free Survival|IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months.|Assessed throughout the study from the first dose of the study drug to the date of progressive disease, death, or 60m.||||percentage||90% Confidence Interval|Number
2669236|NCT01497756|Secondary|Side Effects|Any recorded complications|Eight months|All patients|||participants|||Number
2669237|NCT01497756|Primary|Usage|Number of patients on whom CAPP is used|Eight months|Entire number of participants|||participants|||Number
2669238|NCT01497665|Secondary|Six Month Overall Survival||Upon enrollment through end of study period (1 year after last patient is enrolled)|Once the study was terminated, no further survival data was collected and there was insufficient number of participants with data collected for this outcome measure.||||||
2669239|NCT01497665|Secondary|Duration of Overall Progression Free Survival||Upon enrollment through end of study period (1 year after last patient is enrolled)|Once the study was terminated, no further efficacy data was collected and there was insufficient number of participants with data collected for this outcome measure.||||||
2669240|NCT01497665|Secondary|Duration of Overall Objective Response||Upon enrollment through end of study period (1 year after last patient is enrolled)|Once the study was terminated, no further data on response was collected and there was insufficient number of participants with data collected for this outcome measure.||||||
2669241|NCT01497665|Secondary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability||Upon enrollment through end of study period (1 year after last patient is enrolled)||||participants|||Number
2669242|NCT01497665|Primary|Overall (Intra-cranial and Extra-cranial) Objective Response Rate in Non-small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis|Tumor response was assessed by Gd-MRI for intracranial lesions and CT/MRI with contrast of chest, abdomen, pelvis for extracranial lesions using modified OVERALL RECIST v1.1 as follows: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions and non-target lesions stable or decreased; Stable Disease (SD), < 30% decrease but <20% increase in target lesions and non-target lesions stable or decreased; Progressive disease (PD), >= 20% (>= 5 mm) increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study, non-target lesions increased or appearance of a new lesion; Overall Response (OR) = CR + PR.|upon enrollment through end of study period (1 year after last patient is enrolled)||||participants|||Number
2669243|NCT01497613|Secondary|Change in Computer Efficacy Measured by Computer Attitude - Efficacy Subscale|Use the computer attitude scale to measure the level of computer efficacy from baseline to 12th month follow-up. Higher score means more efficacy towards computer. Range (5-25)|Baseline and 12th month follow-up|Some participants did not complete the questionnaire. 148 participants from PRISM B and 149 from PRISM C contributed to at least one of the two time points.|||units in scale||Standard Deviation|Mean
2669244|NCT01497613|Secondary|Change in Computer Efficacy Measured by Computer Attitude - Efficacy Subscale|Use the computer attitude scale to measure the level of computer efficacy from baseline to 12th month follow-up. Higher score means more efficacy towards computer. Range (5-25)|Baseline and 6th month follow-up|Some participants did not complete the questionnaire. 148 participants from PRISM B and 149 from PRISM C contributed to at least one of the two time points.|||units in scale||Standard Deviation|Mean
2669245|NCT01497613|Secondary|Change in Computer Interest Measured by Computer Attitude - Interest Subscale|Use the computer attitude scale to measure the level of computer interest from baseline to 12th month follow-up. Higher score means more interest towards computer. Range (5-25)|Baseline and 12th month follow-up|Some participants did not complete the questionnaire. 148 participants from PRISM B and 149 from PRISM C contributed to at least one of the two time points.|||units in scale||Standard Deviation|Mean
2669246|NCT01497613|Secondary|Change in Computer Interest Measured by Computer Attitude - Interest Subscale|Use the computer attitude scale to measure the level of computer interest from baseline to 6th month follow-up. Higher score means more interest towards computer. Range (5-25)|Baseline and 6th month follow-up|Some participants did not complete the questionnaire. 148 participants from PRISM B and 149 from PRISM C contributed to at least one of the two time points.|||units in scale||Standard Deviation|Mean
2669247|NCT01497613|Secondary|Change in Technology Adoption Measured by Technology Acceptance Questionnaire|Measures the level of technology adoption from baseline to 12th month follow-up. Higher score means more acceptance. Range (6-42)|baseline and 12 months|Some participants did not answer the questionnaire. 149 participants from PRISM B and 149 from PRISM C contributed to at least one of the two time points.|||units on a scale||Standard Deviation|Mean
2669248|NCT01497613|Secondary|Changes in Technology Proficiency Measured by Technology Proficiency Scale|Measures the level of technology proficiency from baseline to 12th month follow-up. A higher score means more computer proficiency. Range (6-30)|baseline and 12 months|Some participants did not complete the questionnaire. 148 participants from PRISM B and 147 from PRISM C contributed to at least one of the two time points.|||units on a scale||Standard Deviation|Mean
2669249|NCT01497613|Secondary|Change in Computer Comfort Measured by Computer Attitude - Comfort Subscale .|Use the computer attitude scale to measure the level of computer comfort from baseline to 12th month follow-up. Higher score means more computer comfort. Range (5-25)|baseline and 12 months|Some participants did not complete the questionnaire. 148 participants from PRISM B and 149 from PRISM C contributed to at least one of the two time points.|||units in scale||Standard Deviation|Mean
2669250|NCT01497613|Secondary|Change in Technology Adoption Measured by Technology Acceptance Questionnaire|Measure the level of technology adoption from baseline to 6th month follow-up. Higher score means more acceptance. Range (6-42)|baseline and 6 months|Some participants did not complete the questionnaire. 149 participants from PRISM B and 149 from PRISM C contributed to at least one of the two time points.|||units on a scale||Standard Deviation|Mean
2669253|NCT01497613|Primary|Change Overall Well-being Measured by SF-36 Overall Well-being Subscale|Use the SF-36 to measure the overall well-being from baseline to 12th month follow-up. Higher score means more peaceful, happy and calm. Range (0-100).|Baseline and 12th month|Some participants did not complete the questionnaire. 149 participants from PRISM B and 149 from PRISM C contributed to at least one of the two time points.|||units in scale||Standard Deviation|Mean
2669254|NCT01497613|Primary|Change in Level of Social Support Measured by Social Support Scale|Measures the level of social support from baseline to 12th month follow-up. Higher score means more social support. Range (6-36).|Baseline and 12th month|Some participants did not complete the questionnaire|||units on a scale||Standard Deviation|Mean
2669255|NCT01497613|Primary|Change in Social Isolation Measured by Friendship Scale|Measures the level of social isolation from baseline to 12th month follow-up. Lower score means less social isolation. Range (0-24) .|Baseline and 12th month|Some participants did not complete the questionnaire. 149 participants from PRISM B and 150 from PRISM C contributed to at least one of the two time points.|||units on a scale||Standard Deviation|Mean
2669256|NCT01497613|Primary|Change Overall Well-being Measured by SF-36 Overall Well-being Subscale|Use the SF-36 scale to measure the overall well-being from baseline to 6th month follow-up. Higher score indicates more peaceful, happy, and calm. Range (0-100)|Baseline and 6th month|Some participants did not complete the questionnaire. 149 participants from PRISM B and 149 from PRISM C contributed to at least one of the two time points.|||units in scale||Standard Deviation|Mean
2669257|NCT01497613|Primary|Change in Level of Social Support Measured by Social Support Scale|Measures the level of social support from baseline to 6th month follow-up. Higher score means more social support. Range (6-36).|Baseline and 6th month|Some participants did not complete the questionnaire|||units on a scale||Standard Deviation|Mean
2669258|NCT01497613|Primary|Change in Social Isolation Measured by Friendship Scale|Measures the level of social isolation from baseline to 6th month follow-up. Lower score means less social isolation. Range (0-24) .|Baseline and 6th month|Some participants did not complete the questionnaire. 149 participants from PRISM B and 133 from PRISM C contributed to at least one of the two time points.|||units on a scale||Standard Deviation|Mean
2669259|NCT01497366|Secondary|Percentage of Participants With Viral Relapse Following Treatment|Viral relapse was defined as HCV RNA ≥ 25 IU/mL in post-treatment after having achieved < LLOQ at last on-treatment measurement, confirmed with 2 consecutive values or last available measurement.|Up to Post-treatment Week 24|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2669260|NCT01497366|Secondary|Percentage of Participants With Virologic Failure During Treatment|"Virologic failure was defined as either~Viral breakthrough: HCV RNA ≥ 25 IU/mL after having previously had HCV RNA < 25 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement~Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement~Non-response: HCV RNA persistently ≥ 25 IU/ml while on treatment (through Week 12)"|Baseline up to Week 24|Full Analysis Set|||percentage of participants|||Number
2669261|NCT01497366|Secondary|Change From Baseline in HCV RNA||Baseline to Week 12|Participants in the Full Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2669262|NCT01497366|Secondary|Percentage of Participants With HCV RNA < LLOQ on Treatment||Up to 12 Weeks|Participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2669263|NCT01497366|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)|SVR24 was defined as HCV RNA < LLOQ 24 weeks after study drug cessation.|Post-treatment Week 24|Full Analysis Set|||percentage of participants|||Number
2669264|NCT01497366|Secondary|Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities||Up to 24 weeks plus 30 days following the last dose of study drug|Safety Analysis Set|||participants|||Number
2669265|NCT01497366|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)|SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; < 25 IU/mL) 12 weeks after study drug cessation.|Post-treatment Week 12|Full Analysis Set|||percentage of participants|||Number
2669266|NCT01497275|Secondary|Overall Survival at 5 Year|Number of participants who were alive at the 5 year time point. (Overall survival will be defined as the time from on-study to death due to any cause.)|5 year|No analysis completed due to study being terminated prior to the 5 year time point.||||||
2669267|NCT01497275|Secondary|Overall Survival at 1 Year|Number of participants who were alive at the 1 year time point. (Overall survival will be defined as the time from on-study to death due to any cause.)|1 year|1 subject did not reach the one year evaluation because the study was terminated.|||participants|||Number
2669268|NCT01497275|Secondary|Number of Participants With Progression Free Survival|Progression-free survival will be defined as time from on-study to disease progression or death, whichever comes first|6 months|Only 3 subjects provided evaluable data at the 6 month time point. 2 subjects did not reach this time-point so they were not assessed for progression|||participants|||Number
2669269|NCT01497275|Primary|Response Rate (Complete Response + Partial Response)|"Disease will be assessed every 3 months.~The Cheson criteria will be used to define response:~Complete Response = Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present prior to therapy.~Partial Response = A decrease of ≥ 50% in the sum of the products of their greatest transverse diameters (SPD) of up to six of the largest dominant nodes or nodal masses. These nodes or masses should be selected according to the following features: a) they should be clearly measurable in at least two perpendicular measurements; b) they should be from as disparate regions of the body as possible; and c) they should include mediastinal and retroperitoneal areas of disease whenever these sites are involved."|3 months|Only 3 subjects completed the drug regimen; 1 subject did not complete due to disease progression; 1 did not complete due to adverse event.|||participants|||Number
2669270|NCT01497262|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity|28 weeks|Safety set includes all patients who received at least one dose of study drug|||Participants|||Number
2669271|NCT01497262|Secondary|Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.|The incidence of events in special areas of safety interest (including bradyarrhythmias, BP increase, liver function, infections and macular oedema) were assessed by the nature and frequency of AE reporting. These areas of special interest have been identified and potential risks of fingolimod based on knowledge from clinical trials and post-marketing reporting.|4 months|Safety set includes all patients who received at least one dose of study drug|||Percent of Participants|||Number
2669272|NCT01497197|Secondary|Number of Subjects With Any Adverse Events (AEs), Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|Baseline up to 15-20 days post r-hCG administration|Safety population included all randomized subjects who received at least one dose of the trial treatment.|||subjects|||Number
2669273|NCT01497197|Secondary|Number of Subjects With Multiple Pregnancies|Multiple pregnancy was defined as the existence of more than one ultrasound confirmed gestational sac in the uterus with fetal heart activity at post-r-hCG Days 35-42.|35 to 42 days post r-hCG administration|MITT included all subjects randomized into trial who received at least 1 dose of Gonal-f® or Luveris®, and completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection). ‘N’=signifies all subjects who showed positive pregnancy test and evaluable for this outcome measure.|||subjects|||Number
2669274|NCT01497197|Secondary|Number of Subjects With Biochemical Pregnancies|Biochemical pregnancy was defined as the pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. Subjects with beta-hCG concentration greater than 10 IU/L were considered as biochemical pregnant.|35 to 42 days post r-hCG administration|MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).|||subjects|||Number
2669275|NCT01497197|Secondary|Cycle Cancellation Rate Prior to r-hCG|If the subject was not administered with r-hCG and withdrew prematurely from the trial, it was considered as cycle cancellation.|Up to 85 days|MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).|||percentage of subjects|||Number
2669276|NCT01497197|Secondary|Total Pregnancy Rate and Clinical Pregnancy Rate|The subject was considered to have a positive pregnancy result if beta-hCG >10 international units per liter (IU/L) and the subject had not menstruated between post-r-hCG Days 15-20. Clinical pregnancy was defined as the existence of at least an US confirmed gestational sac in the uterus with fetal heart activity post-r-hCG Days 35-42.|35-42 days post r-hCG administration|MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).|||percentage of subjects|||Number
2669277|NCT01497197|Secondary|Number of Fetal Sacs With Detectable Heart Beats|Number of fetal sacs with detectable heart beats was evaluated by US on Days 35-42 post r-hCG to confirm clinical pregnancy|35-42 days post r-hCG administration|MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all participants who showed positive pregnancy test and evaluable for this outcome measure.|||Fetal sacs||Standard Deviation|Mean
2669278|NCT01497197|Secondary|Number of Fetal Sacs With Activity|Number of fetal sacs with activity was evaluated by ultrasound scan (US) on Days 35-42 post r-hCG to confirm clinical pregnancy.|35-42 days post r-hCG administration|MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all participants who showed positive pregnancy test and evaluable for this outcome measure.|||Fetal sacs||Standard Deviation|Mean
2669279|NCT01497197|Secondary|Implantation Rate|The implantation rate was determined as number of fetal sacs divided by the number of embryos transferred post r-hCG administration.|35-42 days post r-hCG administration|MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all subjects who showed positive pregnancy test and evaluable for this outcome measure.|||fetal sacs/embryo transferred||Standard Deviation|Mean
2669280|NCT01497197|Secondary|Total Number of Stimulation Treatment Days|The total number of stimulation treatment days for each subject was determined based on the treatment administration information collected in the case report form.|6 days post stimulation (Number of stimulation days+6 days)|MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).|||days||Standard Deviation|Mean
2669281|NCT01497197|Secondary|Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)|Mean daily dose of FSH was to be determined by dividing the total daily dose by the number of stimulation days.|Screening|Data was not analysed as per planned analysis due to frequent protocol violations/deviations, there was no subject eligible to be analyzed per protocol.||||||
2669282|NCT01497197|Primary|Total Number of Oocytes Retrieved Per Subject Following Ovarian Stimulation|Ovarian stimulation was performed using in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The total number of oocytes collected per subject following stimulation was reported.|34-38 hours post r-hCG administration|Modified intention-to-treat (MITT) included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following recombinant human follicle stimulating hormone (r-hFSH) stimulation and r-hCG injection).|||oocytes||Standard Deviation|Mean
2669283|NCT01497171|Primary|Comparison of the Proportion of Subjects in Each Group, Who Achieve Anatomic Success at 12 Month Follow-up.|Anatomical success will be measured using a composite index including: lack of specific prolapse symptoms, no interval treatment and no observed prolapse beyond 1 cm from the hymen.|12 months|No analysis was done due to early termination of the study.||||||
2669284|NCT01497067|Primary|Central Endothelial Cell Density (All Eyes)|A microscope was used to photograph corneal endothelial cells (cells on the back of the cornea). Three images at the center of the cornea were obtained and sent to a central reading center for analysis. All recorded data from images were used in the analysis. A higher value for density represents a healthier cornea.|Year 4 to Year 10 postoperative from previous study (C-02-23, C-02-40, C-03-21, and C-05-57)|All subjects enrolled in the study (Safety Analysis). Some subjects were implanted in both eyes and therefore 2 eyes were enrolled.|||cells/mm^2|eyes|Standard Deviation|Mean
2669285|NCT01496846|Secondary|Anesthetic Success Rate of an IANB With Articaine|Success rate of an IANB with articaine using a conventional IANB technique|15 min after injection|"All enrolled participants (N=201) received an IANB with Articaine. Two participants were excluded from data analysis due to inadequate lip numbness (IANB was considered missed block); thus N=199 were analyzed for success rate."|||Participants|||Count of Participants
2669286|NCT01496846|Primary|Anesthetic Success Rate of Supplemental Infiltration Injection|Following an unsuccessful IANB, supplemental infiltration anesthesia with either articaine or lidocaine was given to achieve complete pulpal anesthesia|5 min after injection||||Participants|||Count of Participants
2669287|NCT01496807|Other Pre-specified|Count of Participants Developing Positive Autoantibody Screen|"Number of participants who developed a positive result during treatment for one or more antibodies of a previously negative screen.~This study was not designed to statistically test the efficacy of treatment, and no inferential analyses will be performed. Investigators planned to look for evidence of serologic and clinical autoimmunity."|Up to 54 Months|All evaluable participants|||Participants|||Count of Participants
2669288|NCT01496807|Secondary|Treatment Related Adverse Events (AEs) - Grade 3 to 5|Percentage of participants with treatment related AEs, Grade 3 to 5. All adverse events, regardless of causality are also reported in the Serious Adverse Event/Other Adverse Event reporting area.|4 Years, 1 Month|All Participants|||Participants|||Count of Participants
2669289|NCT01496807|Secondary|Overall Survival (OS)|OS: The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.|Up to 54 Months|All evaluable participants|||months||95% Confidence Interval|Median
2669290|NCT01496807|Secondary|Progression Free Survival (PFS)|Immune Related Progressive Disease (irPD): increase in tumor burden >25% relative to nadir (minimum recorded tumor burden) confirmed by repeat consecutive assessment at least 4 weeks later.|Up to 54 Months|All evaluable participants|||months||95% Confidence Interval|Median
2669291|NCT01496807|Secondary|Number of Participants With Overall Response (OR)|Overall Response: Complete Response (CR) + Partial Response (PR) by immune-related response criteria (irRC). Immune Related CR (irCR): Complete disappearance of all lesions (whether measurable or not, and no new lesions, and confirmation by a repeat consecutive assessment no less than 4 weeks from date first documented. Immure Related PR (irPR): decrease in tumor burden >50% relative to baseline confirmed by repeat consecutive assessment at least 4 weeks later.|Up to 54 Months|All evaluable participants|||Participants|||Count of Participants
2669292|NCT01496807|Primary|Maximum Tolerated Dose (MTD) of Ipilimumab|MTD of Ipilimumab (Yervoy) combined with peginterferon alfa-2b (Sylatron). To assess the safety, toxicities and tolerability of a regimen of 3 μg/kg weekly Sylatron with concurrent induction Yervoy at 3 mg/kg, then if well tolerated, at 10 mg/kg every three weeks four times, in participants with unresectable stages IIIC/IV melanoma, and to define a well tolerated dose of Yervoy in that combination.|Up to 48 Months|All participants|||mg/kg|||Number
2669293|NCT01496807|Primary|Maximum Tolerated Dose (MTD) of Sylatron|MTD of peginterferon alfa-2b (Sylatron) combined with Ipilimumab (Yervoy).|Up to 48 Months|All participants|||μg/kg s|||Number
2669294|NCT01496469|Secondary|Change From Baseline in Serum Urate Levels at Week 6||Baseline and Week 6|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication and had a baseline value and at least 1 post-baseline value available, with last observation carried forward.|||mg/dL||Standard Error|Least Squares Mean
2669295|NCT01496469|Secondary|Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6|The change in 24-hour mean DBP measured at final visit or Week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication and had a baseline value and at least 1 post-baseline value available, with last observation carried forward.|||mmHg||Standard Error|Least Squares Mean
2669296|NCT01496469|Primary|Change From Baseline in 24-hour Mean Systolic Blood Pressure (SBP) Measured by Ambulatory Blood Pressure Monitoring at Week 6|The change in 24-hour mean SBP measured at final visit or Week 6 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 6|FAS included all participants who were randomized and received at least 1 dose of double-blind study medication and had a baseline value and at least 1 post-baseline value available, with last observation carried forward.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2669297|NCT01496456|Secondary|Lesion Survival After 3 Years|Discrete time survival analysis of time to first lesion progression.|3 years|Radiographic lesion increase by PWA+DSR. A tooth was included up until the time the lesion first increased.|||Lesions|Lesions||Number
2669298|NCT01496456|Secondary|Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories|Radiographic assessment of lesion depth category (R1-R5) by single radiograph assessment (SRA).|Baseline through 3 years||||Lesions|Lesions||Number
2669299|NCT01496456|Primary|Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous)|Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR).|Baseline through 3 years|Pairwise assessment: visual (PWA) + digital subtraction radiography (DSR).|||Lesions|Lesions||Number
2669300|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in AUC for Glucagon During OGTT|The change between the AUC for glucagon at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||ng*hours/L||Standard Error|Least Squares Mean
2669301|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in AUC for Insulin/Glucose Ratio During OGTT|The change between the AUC for insulin/glucose ratio at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||pmol*hr/mmol||Standard Error|Least Squares Mean
2669302|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in AUC for C-peptide During OGTT|The change between the AUC for C-peptide at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||nmol*hours/L||Standard Error|Least Squares Mean
2669303|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in AUC for Insulin During OGTT|The change between the AUC for insulin at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||pmol*hours/L||Standard Error|Least Squares Mean
2669304|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in the Area Under the Plasma Concentration-time Curve (AUC) for Glucose During OGTT|The change between the AUC for glucose at weeks 6 and 24 relative to baseline. AUC will be calculated based on measurements at 0, 30, 60 and 120 minutes. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mmol*hours/L||Standard Error|Least Squares Mean
2669305|NCT01496430|Secondary|Change From Baseline to Week 6 and Week 24 in 2h Glucose During Oral Glucose Tolerance Testing (OGTT)|The change between the glucose value collected at weeks 6 and 24 relative to baseline. Oral glucose tolerance test measures glucose, insulin, C-peptide, insulin/glucose ratio, and glucagon through blood samples drawn at 0, 30, 60, and 120 minutes following consumption of a 75 g glucose beverage.|Baseline and Weeks 6 and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mmol/L||Standard Error|Least Squares Mean
2669306|NCT01496430|Secondary|Change From Baseline in Fasting Plasma Glucose|The change between the fasting plasma glucose value collected at each week indicated relative to baseline.|Baseline and Weeks 2, 4, 6, 8, 12, 16, 20, and 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.|||mmol/L||Standard Error|Least Squares Mean
2669307|NCT01496430|Secondary|Change From Baseline in HbA1c|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated relative to baseline.|Baseline and Weeks 2, 4, 6, 8, 12, 16 and 20|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.|||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
2669308|NCT01496430|Secondary|Time to First Glycemic Rescue|The time to the first instance of participants requiring glycemic rescue during study.|24 Weeks|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication.|||Days||Inter-Quartile Range|Median
2669309|NCT01496430|Secondary|Percentage of Participants Requiring Rescue Glycemic Therapy|Percentage of participants requiring rescue glycemic therapy during study.|24 Weeks|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication.|||percentage of participants|||Number
2669310|NCT01496430|Secondary|Change From Baseline in the Trough (22 to 24 Hours After Dosing) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring|The change in trough diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
2669311|NCT01496430|Secondary|Change From Baseline in the Trough (22 to 24 Hours After Dosing) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring|The change in trough systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
2669325|NCT01496352|Secondary|Renal Function|Changes in serum creatinine from surgery on Day 1 until 14 days after surgery|Baseline up to Day 14|As treated|||Participants|||Number
2669731|NCT01493089|Secondary|Median Time to Sustained Partial Response|Reduction in severity of heartburn by 2 points or more on a 9-point Likert severity scale, which is sustained for 45 minutes or more|up to 14 days|mITT|||Minutes||95% Confidence Interval|Median
2669312|NCT01496430|Secondary|Change From Baseline in the 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded during the first 12 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
2669313|NCT01496430|Secondary|Change From Baseline in the 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring|The change in 12-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded during the first 12 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
2669314|NCT01496430|Secondary|Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in nighttime (12am to 6am) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
2669315|NCT01496430|Secondary|Change From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in nighttime (12am to 6am) mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
2669316|NCT01496430|Secondary|Change From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in daytime (6am to 10pm) mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
2669317|NCT01496430|Secondary|Change From Baseline in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in daytime (6am to 10pm) mean systolic blood pressure measured week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
2669318|NCT01496430|Secondary|Change From Baseline in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean diastolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
2669319|NCT01496430|Secondary|Change From Baseline in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean systolic blood pressure measured at week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Observed cases.|||mm Hg||Standard Error|Least Squares Mean
2669320|NCT01496430|Secondary|Change From Baseline in Trough Sitting Clinic Diastolic Blood Pressure|The change in trough diastolic blood pressure measured at week 8 relative to baseline. The trough is the average of the non-missing values of the 3 serial trough sitting diastolic blood pressure measurements.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.|||mm Hg||Standard Error|Least Squares Mean
2669321|NCT01496430|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 relative to baseline.|Baseline and Week 24|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.|||percentage glycosylated hemoglobin||Standard Error|Least Squares Mean
2669322|NCT01496430|Primary|Change From Baseline in Trough Sitting Clinic Systolic Blood Pressure|The change in trough systolic blood pressure measured at week 8 relative to baseline. The trough is the average of the non-missing values of the 3 serial trough sitting systolic blood pressure measurements.|Baseline and Week 8|The full analysis set included all randomized participants who took at least 1 dose of double-blind study medication. Missing values were imputed using last observation carried forward.|||mm Hg||Standard Error|Least Squares Mean
2669323|NCT01496352|Secondary|Incidence of Surgical Site Infection|The incidence of probable or definite surgical site infection as determined by the Investigator.|Up to 30 Days After Surgery|As treated|||Participants|||Number
2669324|NCT01496352|Secondary|Antibiotic Resistance|Methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococcus presence at surgery on Day 1 and 5 days after surgery|Baseline up to Day 5|As Treated|||Participants|||Number
2669326|NCT01496352|Secondary|Maximal Plasma Concentration (Cmax)|Maximal plasma concentration (Cmax)of gentamicin and vancomycin using sparse sampling from baseline (DFA-02 application during surgery on Day 1) to 4 days after surgery|1, 6, 24, 48, 96 hours post-dose|All subjects receiving DFA-02 active gel|||mcg/mL||Standard Deviation|Mean
2669327|NCT01496352|Primary|Area Under Curve (AUC)|Area under the curve (AUC) of plasma gentamicin and vancomycin levels using sparse sampling from baseline (DFA-02 application during surgery on Day 1) to 4 days after surgery|1, 6, 24, 48 96 hours post-dose|All Subjects Receiving Active Drug|||mcg/h/mL||Standard Deviation|Mean
2669328|NCT01496352|Primary|Number of Patients With Adverse Events, Laboratory, Physical Examination Changes|Safety and tolerability measured by number of patients with adverse events or changes in laboratory or physical examination findings from baseline (DFA-02 application during surgery on Day 1) to 30 days after surgery.|Baseline up to Day 30|As Treated|||Participants|||Number
2669329|NCT01496313|Secondary|Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.||Week 3 to week 60 (maximum)|All patients who received at least 1 dose of vandetanib and for whom quantifiable plasma concentration data were available.|||ng/ml||Standard Deviation|Mean
2669330|NCT01496313|Secondary|Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm||Randomization to Week 60 (maximum)|Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD|||% change||Standard Deviation|Mean
2669331|NCT01496313|Secondary|Time to Objective Response (RECIST 1.1) by Treatment Arm||Randomization to Week 60 (maximum)|Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD|||Months||95% Confidence Interval|Median
2669332|NCT01496313|Secondary|Duration of Objective Response (RECIST 1.1) by Treatment Arm||Randomization to Week 60 (maximum)|Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD|||Months||95% Confidence Interval|Median
2669333|NCT01496313|Secondary|Best Objective Response||Randomisation to week 60 (maximum)|Per RECIST v1.1 for target lesions: CR, disappearance of all target lesions; PR, at least a 30% decrease in the sum of diameters of target lesions; Progressive disease (PD), at least 20% increase in the sum of diameters of target lesions; Stable disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD|||Participants|||Number
2669334|NCT01496313|Primary|Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator|ORR=proportion of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1|Randomisation to week 60 (maximum)|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial response (PR), at least a 30% decrease in the sum of diameters of target lesions; ORR = CR + PR|||Proportion of participants||95% Confidence Interval|Number
2669335|NCT01496287|Secondary|Tube Retention|Tube retention is the presence of a tympanostomy tube placed successfully by the Tula TDS device across the tympanic membrane at the two-week follow-up visit.|2 weeks post procedure|Only 62 of the initial 70 subjects achieved procedure success, and were present for 2 week follow-up assessment with Tula tube in situ, such that tube retention could be measured.|||ears|Participants||Number
2669336|NCT01496287|Secondary|Procedure Tolerability|"Procedure Tolerability is defined as the proportion of subjects reporting the procedure as tolerable, where tolerable is defined as a score of 0 through 3, using the Wong-Baker FACES pain scale.The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Procedure Tolerability will be determined on a per patient basis, with the patient's score being the average of the scores for the left and right ear if both ears are successfully treated with the Tube Delivery System.~Tolerability was defined as an average post-procedure pain score (of treated ears) <= 3"|Day 0 (day of procedure)||||participants|||Number
2669337|NCT01496287|Secondary|Procedure Success|Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis.|Day 0 (day of procedure)||||participants|||Number
2669338|NCT01496287|Primary|Device Success|Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis.|Day 0 (day of procedure)|Analysis population includes subjects who had completed the local anesthesia procedure (iontophoresis) and in which a TDS tube delivery device was attempted.|||devices|Participants||Number
2669339|NCT01496287|Primary|Number of Participants With Procedural, Serious, and Device-Related Adverse Events|Adverse events which are procedural, serious, and device-related.|procedure up to 2 weeks post procedure||||participants|||Number
2669340|NCT01496274|Secondary|Annualized Spontaneous Bleeding Events Compared Between 7 Day Prophylactic and Extended Regimens|Median number of spontaneous bleeds per year per subject comparing 7-, 10- and 14- day prophylactic regimens.|During treatment, between median 240 and 386 days per subject.|Efficacy Population|||bleeds/year/subject||Inter-Quartile Range|Median
2669341|NCT01496274|Secondary|Investigator's (or Surgeon's) Overall Clinical Assessment of Hemostatic Efficacy for Surgical Prophylaxis, Based on a Four Point Ordinal Scale (Excellent, Good, Moderate, Poor/No Response)|Number of surgical events treated prophylactically with rIX-FP that resulted in hemostatic efficacy of excellent, good, moderate, poor/no response, according to the Investigator's (surgeon's) overall assessment of hemostatic efficacy for surgical prophylaxis.|Up to 14 days after surgery|Surgical Population|||events|Participants||Number
2671145|NCT01479478|Secondary|"Count of Neonates Requiring a Rule-out Sepsis Evaluation"|Outcome was based on performance of neonatal blood culture.|Up to 14 days following delivery|Participants with available data were included in the analysis.|||Participants|||Count of Participants
2669342|NCT01496274|Secondary|Clearance of a Single Dose of rIX-FP|PK data are presented for a single 50 IU/kg dose of rIX-FP.|336 hours|The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.|||mL/hr||Standard Deviation|Mean
2669343|NCT01496274|Secondary|Area Under the Curve (AUC)|AUC to the last sample with quantifiable drug concentration (AUClast) of a single dose of rIX-FP. PK data are presented for a single 50 IU/kg dose of rIX-FP.|336 hours|The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.|||IU*hr/dL||Standard Deviation|Mean
2669344|NCT01496274|Secondary|Half-life (t1/2) of a Single Dose of rIX-FP|PK data are presented for a single 50 IU/kg dose of rIX-FP.|336 hours|The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.|||hour||Standard Deviation|Mean
2669345|NCT01496274|Secondary|Incremental Recovery of rIX-FP|Pharmacokinetic (PK) data are presented for a single 50 IU/kg dose of rIX-FP.|336 hours|The PK population comprised 46 subjects who received at least 1 dose of rIX-FP at 50 IU/kg. Data are presented for subjects from the PK population who had a sufficient number of analyzable PK samples for evaluation of the PK profile of rIX-FP.|||(IU/dL)/(IU/kg)||Standard Deviation|Mean
2669346|NCT01496274|Secondary|rIX-FP Consumed Per Month While Maintaining Assigned Prophylactic Treatment Interval During Routine Prophylaxis.|Time frame: For Prophylaxis Arm 7-, 10- and 14-day regimens, median 269, 240 and 386 days respectively. For On-demand Arm, prophylaxis regimen, median 316 days.|Median 269, 240, 386 and 316 days, respectively (see Description)|Efficacy Population|||IU/kg/month||Standard Deviation|Mean
2669347|NCT01496274|Secondary|Investigator's Overall Clinical Assessment of Hemostatic Efficacy for Treatment of Bleeding Episodes, Based on a Four Point Ordinal Scales (Excellent, Good, Moderate, Poor/No Response)|Number of bleeding episodes requiring treatment that resulted in hemostatic efficacy of excellent, good, moderate, poor/no response, according to the Investigator's clinical assessment of hemostatic efficacy, expressed as a percentage of the bleeding episodes requiring treatment.|For the duration of the study; median 20.27 months|Efficacy Population|||percentage of bleeding episodes|Participants||Number
2669348|NCT01496274|Secondary|Proportion of Bleeding Episodes Requiring One or ≤ Two Injections of rIX-FP to Achieve Hemostasis|Number of injections required to achieve hemostasis expressed as a percentage of the bleeding episodes requiring treatment.|For the duration of the study; median 20.27 months.|Efficacy Population|||percentage of bleeding episodes treated|Participants||Number
2669349|NCT01496274|Secondary|Number of Subjects Developing Antibodies Against rIX-FP||For the duration of the study; median 20.27 months.|Safety Population|||participants|||Number
2669350|NCT01496274|Secondary|The Frequency of Related Adverse Events|The percentage of participants experiencing treatment-related adverse-events (TEAEs).|For the duration of the study; median 20.27 months.|Safety Population|||Percentage of participants|||Number
2669351|NCT01496274|Primary|Number of Subjects Developing Inhibitors Against Factor IX (FIX)|The number of participants developing inhibitors against factor IX (FIX) along with the 95% Clopper-Pearson confidence interval, are summarized for subjects with 50 or more exposure days (EDs) to rIX-FP, and for all participants in the study.|Up to 27.7 months (maximum)|Safety Population|||participants||95% Confidence Interval|Number
2669352|NCT01496274|Primary|Change in Frequency of Spontaneous Bleeding Events Between On-demand and Prophylaxis Treatments (Annualized)|Subjects in the on-demand arm received on-demand dosing with rIX-FP for up to 26 weeks (on-demand regimen), and then received weekly prophylaxis with rIX-FP for the remainder of the study (prophylaxis regimen). The effectiveness of prophylaxis in comparison to on-demand therapy was investigated by comparing the same subject's annualized spontaneous bleeding rate (AsBR) during the on-demand regimen and during the prophylaxis regimen.|Up to 26 weeks for on-demand regimen, and between 1 and 17 months for prophylaxis regimen.|This analysis includes only the participants assigned to the on-demand arm who received at least 1 dose of rIX-FP in the on-demand regimen and at least 1 dose of rIX-FP in the prophylaxis regimen.|||bleeds/year/subject||Inter-Quartile Range|Median
2669353|NCT01496248|Secondary|Clinical Global Index|This was developed for use in psychopharmacology trials and then, it has been expanded in its use as a standard primary measure in studies investigating the efficacy of pharmacological treatments for various psychiatric illnesses such as depression, anxiety disorder, and bipolar disorder. The CGI-S rates the severity of the patient's illness, on a 7-point scale ranging from 1(Normal) 1 to 7(Extremely ill), according to the clinician's experience of patients suffering from the same condition.|8 weeks||||units on a scale||Standard Deviation|Mean
2669354|NCT01496248|Secondary|Clinical Global Index|This was developed for use in psychopharmacology trials and then, it has been expanded in its use as a standard primary measure in studies investigating the efficacy of pharmacological treatments for various psychiatric illnesses such as depression, anxiety disorder, and bipolar disorder. The CGI-S rates the severity of the patient's illness, on a 7-point scale ranging from 1(Normal) 1 to 7(Extremely ill), according to the clinician's experience of patients suffering from the same condition.|Baseline||||units on a scale||Standard Deviation|Mean
2669355|NCT01496248|Secondary|Montgomery Asberg Depression Rating Scale|This is a 10-item depression rating scale, widely used in depressed patients. Each item is rated from 0 to 6. A total score is the range from 0(none) to 60(most severe). The MADRS has been designed to measure severity of depression in clinical samples and be sensitive to change during antidepressant treatment.|8 weeks||||units on a scale||Standard Deviation|Mean
2669356|NCT01496248|Secondary|Montgomery Asberg Depression Rating Scale|This is a 10-item depression rating scale, widely used in depressed patients. Each item is rated from 0 to 6. A total score is the range from 0(none) to 60(most severe). The MADRS has been designed to measure severity of depression in clinical samples and be sensitive to change during antidepressant treatment.|Baseline||||units on a scale||Standard Deviation|Mean
2669394|NCT01495988|Primary|Maximum Tolerated Dose|To establish the maximum tolerated dose (MTD) of bevacizumab in combination with vemurafenib and cobimetinib.|Until MTD determined (up to 6 months)|The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed. MTD could not be determined.||||||
2669357|NCT01496248|Secondary|Visual Analogue Scale|This has been described as simple, highly sensitive, and reliable rating scales for subjective experiences. The VAS in this study is used for assessing of variation in severity of residual symptoms. The subject is asked to indicate his/her perceived symptom severity along a 100 mm horizontal line, and this rating is then measure from the left edge (0, no symptom) to right edge (100, most severe).|8 weeks||||units on a scale||Standard Deviation|Mean
2669358|NCT01496248|Secondary|Visual Analogue Scale|This has been described as simple, highly sensitive, and reliable rating scales for subjective experiences. The VAS in this study is used for assessing of variation in severity of residual symptoms. The subject is asked to indicate his/her perceived symptom severity along a 100 mm horizontal line, and this rating is then measure from the left edge (0, no symptom) to right edge (100, most severe).|Baseline||||units on a scale||Standard Deviation|Mean
2669359|NCT01496248|Primary|Depression Residual Symptom Scale|This consists of 25 items and includes specific residual depressive symptoms, e.g. sadness and anhedonia, lack of energy, psychomotor retardation and anxiety, as well as items reflecting subjective feelings of vulnerability, loss of internal reference points and increased emotionalism. Patients were instructed to compare the past 7 days with the period before the very first symptoms of the most recent depressive episode. Each item is scored as 0 to 3. A total score is the range from 0(none) to 75(most severe).|8 weeks||||units on a scale||Standard Deviation|Mean
2669360|NCT01496248|Primary|Depression Residual Symptom Scale|This consists of 25 items and includes specific residual depressive symptoms, e.g. sadness and anhedonia, lack of energy, psychomotor retardation and anxiety, as well as items reflecting subjective feelings of vulnerability, loss of internal reference points and increased emotionalism. Patients were instructed to compare the past 7 days with the period before the very first symptoms of the most recent depressive episode. Each item is scored as 0 to 3. A total score is the range from 0(none) to 75(most severe).|Baseline||||units on a scale||Standard Deviation|Mean
2669361|NCT01496183|Other Pre-specified|Laboratory Breakfast Intake|Total kcal intake at breakfast in a laboratory setting at baseline and after 2 week of treatment with olanzapine or placebo|baseline and 2 week treatment|The Laboratory Breakfast Intake assessment was not performed at the start of the study but was initiated during the course of the study. Only 3 participants from the Placebo group and 6 participants from the Olanzapine group completed the Laboratory Breakfast Intake assessment.|||kcal||Standard Deviation|Mean
2669362|NCT01496183|Secondary|Physical Activity as Measured Using a Physical Activity Monitor|Change from baseline in physical activity. Physical activity was measured using an activity monitor that subjects wore around their waist throughout baseline and treatment days. Subjects were instructed to remove the monitor when sleeping or engaging in water-based activities, and to report on a daily log the times that they were wearing and removing the device. Physical activity was monitored during weekdays and weekend days. Physical activity data were collected in 60-second epochs. The results are reported as average counts per day of physical activity for weekdays and weekend days at baseline and 2 week treatment.|baseline and 2 week treatment|Due to poor participant's compliance with the study requirements for physical activity data collection, the data from 4 participants from the olanzapine group could not be used for analysis purpose.|||counts per day||Standard Deviation|Mean
2669363|NCT01496183|Secondary|HDL|High-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo|baseline and 2 weeks treatment|Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 1 participant from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 12.|||mg/dl||Standard Deviation|Mean
2669364|NCT01496183|Secondary|LDL|Low-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo|baseline and 2 weeks treatment|Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 1 participant from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 12.|||mg/dl||Standard Deviation|Mean
2669365|NCT01496183|Secondary|Change From Baseline Total Cholesterol|Total cholesterol at baseline and after 2 weeks treatment with olanzapine or placebo|baseline and 2 weeks treatment|Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 1 participant from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 12.|||mg/dl||Standard Deviation|Mean
2669366|NCT01496183|Secondary|Change From Baseline in Insulin|Insulin (µIU/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo|Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)|Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 2 participants from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 11.|||µIU/ml||Standard Deviation|Mean
2669367|NCT01496183|Secondary|Change From Baseline in Leptin|Leptin (ng/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo|Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)|Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 2 participants from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 11.|||ng/ml||Standard Deviation|Mean
2669368|NCT01496183|Secondary|Change From Baseline in Glucose|Glucose (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo|Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)|Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 2 participants from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 11.|||mg/dl||Standard Deviation|Mean
2669395|NCT01495975|Secondary|Unplanned Readmission or ED Visit|Unplanned readmission to any hospital within 30 days of discharge. Emergency department admission to any hospital within 30 days of discharge.|1 month after discharge|||||||
2669396|NCT01495975|Secondary|Diabetes Self-Management||1 month from discharge|||||||
2669369|NCT01496183|Secondary|Change From Baseline Triglycerides|Triglycerides (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo|Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)|Note regarding the difference between the Overall Number of Participants Analyzed and the Participant Flow: Blood sample could not be collected from 1 participant from the Placebo Group and 1 participant from the Olanzapine Group. Therefore, the number of participants analyzed for the Placebo Group is 5 and for the Olanzapine Group is 12.|||mg/dl||Standard Deviation|Mean
2669370|NCT01496183|Secondary|Change From Baseline in Resting Metabolic Rate|Resting metabolic rate at baseline and after 2 weeks of treatment|baseline and 2weeks of treatment||||kcal/24 hours||Standard Deviation|Mean
2669371|NCT01496183|Secondary|Change From Baseline in 24-Hour Dietary Recall|24-hour dietary intake recall at baseline and after 2 weeks of treatment with olanzapine or placebo|Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)||||kcal/day||Standard Deviation|Mean
2669372|NCT01496183|Secondary|Change From Baseline in Body Composition|lean body mass (kg) and fat mass (kg) at baseline and after 2 weeks of treatment with olanzapine or placebo|baseline and 2 weeks of treatment (olanzapine or placebo)|The Body Composition assessment was not implemented at the start of the study but once the study already started. Therefore, not all study participants who completed the study got the Body Composition assessment done. Only 3 participants in the Placebo Group and 6 participants in the Olanzapine Group got the Body Composition assessment done.|||kg||Standard Deviation|Mean
2669373|NCT01496183|Primary|Change From Baseline in Weight||Assessed at baseline and 2 weeks||||Kg||Standard Deviation|Mean
2669374|NCT01496157|Secondary|PET Detection of Metastatic Disease at Initial Staging|To compare the detection of bone and nodal metastatic disease by DCFBC PET at initial staging to detection by available conventional imaging modalities (bone scan, CT, MRI) and biopsy pathology.|24 months|Data was not collected for this outcome measure.||||||
2669375|NCT01496157|Primary|PET Detection of Primary Prostate Cancer|To compare number of participants with positive or negative uptake of 18F-DCFBC in primary prostate cancer by DCFBC PET to prostatectomy pathology as determined by tissue step-section analysis in men with biopsy-positive prostate cancer (Gleason score > 4+3=7).|24 months||||Participants|||Count of Participants
2669376|NCT01496131|Secondary|Number of Subjects With a Doubling in Number of T-cells in Tumor Biopsy From Baseline at Pre-radiotherapy (Pre-RT) and Post-radiotherapy (Post-RT)|Doubling in number of T-cells was assessed by immunologic responses (in the tumor microenvironment) in subjects consenting to undergo study biopsies. Baseline was defined as the measurement taken within 8 weeks of prior to the first dose of study medication (Day 1).|Baseline, Week 6-12 (Pre-RT), Week 40 (Post-RT)|"Analysis population included only the subjects who were randomized and provided consent for biopsy and whose baseline measurement was considered as evaluable. Here, number analyzed signifies subjects evaluable at specified time point and number analyzed=0 signifies that no subjects were evaluable at the specified time point."|||Participants|||Count of Participants
2669377|NCT01496131|Secondary|Number of Subjects With Progression/Recurrence Status Based on Prostate-specific Antigen (PSA) Levels|"Progression/recurrence status was reported based on Prostate-specific Antigen (PSA) Levels. Recurrence of PSA after completion of therapy represents disease progression and was determined using the American Society for Therapeutic Radiology and Oncology (ASTRO) Phoenix criteria. These criteria define biochemical recurrence after radiation therapy as a PSA level equal to the lowest (nadir) PSA level achieved after therapy plus 2 nanogram per milliliter."|From randomization up to 24 months|Analysis population included all subjects randomized in the study.|||Participants|||Count of Participants
2669378|NCT01496131|Primary|Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 190 (Post-radiation)|MUC1-specific systemic immune response was measured by intracellular cytokine antigen specific staining following a period of in vitro stimulation (IVS) with overlapping 15-mer peptide pools encoding the tumor-associated antigen (TAA) MUC-1. Baseline was defined as the measurement taken prior to the first dose of study medication (Day 1).|Baseline and Day 190 (Post-radiation)|"Analysis population included only subjects who had scored positive to viral pool in peripheral blood mononuclear cells and were considered as evaluable. Here, Number of Participants Analyzed signifies subjects evaluable for this outcome measure."|||Participants|||Count of Participants
2669379|NCT01496131|Primary|Number of Subjects With Change From Baseline in the Mucinous Glycoprotein 1 (MUC1) Specific Systemic T-Cells Immune Response at Day 60 (Pre-Radiation)|MUC1-specific systemic immune response was measured by intracellular cytokine antigen specific staining following a period of in vitro stimulation (IVS) with overlapping 15-mer peptide pools encoding the tumor-associated antigen (TAA) MUC-1. Baseline was defined as the measurement taken prior to the first dose of study medication (Day 1).|Baseline and Day 60 (Pre-Radiation)|"Analysis population included only subjects who had scored positive to viral pool in peripheral blood mononuclear cells and were considered as evaluable. Here, Number of Participants Analyzed signifies subjects evaluable for this outcome measure."|||Participants|||Count of Participants
2669380|NCT01496066|Secondary|Mean BSCVA|"Mean BSCVA for the best case cohort (no macular problems) at 6 months postoperatively was compared between the LAL treatment group and the monofocal control group. Endpoint success was to be achieved if the difference in mean BSCVA between the LAL cohort and the monofocal control group is within 1 line (0.1 LogMAR) (non-inferiority margin or delta)."|6 months|ITT population best case cohort with no macular problems|||LogMAR||Standard Deviation|Mean
2669381|NCT01496066|Secondary|Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively|For eyes with <0.75 D of cylinder at pre-adjustment (LAL)/17-21 days (control group), percent mean absolute reduction in MRSE by subject in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in mean absolute MRSE in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group.|6 months|Participants with eyes in ITT with <0.75 D of cylinder prior to light treatment|||percent absolute reduction in MRSE||Standard Deviation|Mean
2669397|NCT01495975|Secondary|Diabetes Distress|Measured by the Problem Areas in Diabetes (PAID) Questionnaire|1 month from discharge|||||||
2669398|NCT01495975|Primary|Glycemic Control|Mean patient-day weighted glucose (from glucometer downloads) over the 30 days after discharge|1 month from discharge||||mg/dL||Standard Deviation|Mean
2669382|NCT01496066|Secondary|Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D)|Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to Pre-Adjustment in the LAL group/17-21 days postoperative in the control group.|6 months|Participants with eyes in ITT with >1.25 D of cylinder prior to light treatment|||percent reduction in cylinder||Standard Deviation|Mean
2669383|NCT01496066|Secondary|Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D)|Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group. Results were to be evaluated for each cylinder adjustment stratum (0.75-1.25 D and 1.50-2.00 D) separately.|6 months|Participants with eyes in ITT with 0.75-1.25 D cylinder prior to light treatment|||percent reduction in cylinder||Standard Deviation|Mean
2669384|NCT01496066|Secondary|Uncorrected Visual Acuity 20/20 or Better|Percent of eyes with UCVA of 20/20 or better in the LAL treatment group at 6 months postoperatively was calculated to determine if it is significantly greater than the percent of eyes with UCVA of 20/20 or better in the monofocal control group at 6 months postoperatively.|6 months|ITT|||percentage of eyes|||Number
2669385|NCT01496066|Primary|Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop|Number (%) of eyes with rotation of LAL meridian of ≤ 5 degrees from Pre-Adjustment to 6 months postop. This endpoint was achieved by taking dilated anterior segment photographs of the LAL at Pre-Adjustment and 6 months postop. The angular difference between a landmark on the LAL and an anatomical landmark on the subjects eye was measured. The same landmarks on the LAL and the subjects eye were used at each time point. The angular difference between the two time points was then determined.|6 months|ITT: The overall number of participants analyzed differs from the other outcome measures because some photographs were unusable due to inadequate lighting, user error, or equipment failure.|||percentage of eyes||95% Confidence Interval|Number
2669386|NCT01496066|Primary|Percent Absolute Reduction in MRSE|Percent absolute reduction in Manifest Refraction Spherical Equivalent (MRSE) from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. It is used to describe an ophthalmic refraction with one number. It is defined as the (sphere)+ 0.5(cylinder). So, if you had a refraction of +1.00-1.00x090 the MRSE would be +0.50, the +1.00 is the sphere and the -1.00 is the cylinder in this example. If you had a refraction of +0.25-1.50x145 the MRSE would be -0.50. The absolute value of the MRSE is taken and its reduction is calculated from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.|6 months|ITT. Any eyes that had an MRSE of zero at Pre-Adjustment were excluded since it is not possible to divide by zero. Therefore the number participants analyzed for this outcome will differ from the number of overall participants in the study.|||percentage of reduction in MRSE||95% Confidence Interval|Mean
2669387|NCT01496066|Primary|Percent Reduction in Manifest Cylinder|Percent reduction in manifest cylinder from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. Manifest cylinder refers to only the astigmatic or cylindrical component of an ophthalmic manifest refraction. For example if someone had a refraction of +0.50-1.00x090, the -1.00 is the manifest cylinder component. The reduction of the manifest cylinder is determined from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.|6 months|ITT. Only eyes that had cylinder in the range of treatment (>=0.75 D) were included in the analysis. Therefore the number of participants analyzed for this outcome measure will not match the overall number of participants in the study.|||percent reduction in manifest cylinder||95% Confidence Interval|Mean
2669388|NCT01495988|Secondary|Correlate Blood Markers of B-RAFV600 Mutation With Treatment Efficacy|Assess the effectiveness of blood reverse transcription polymerase chain reaction (RT-PCR) assay for BRAFV600 as a surrogate biomarker for tumor response and resistance in patients receiving vemurafenib/cobimetinib +/- bevacizumab.|Upon completion of the protocol (3 years)|The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.||||||
2669389|NCT01495988|Secondary|Effects of the Addition of Bevacizumab on Tumor Angiogenesis, Resistance Mechanisms and Immune Function|Perform a variety of correlative studies aimed at understanding the effects of vemurafenib/cobimetinib, and bevacizumab administration relative to vemurafenib/cobimetinib on tumor angiogenesis, resistance mechanisms and immune function.|Upon completion of the protocol (3 years)|The trial was terminated prematurely and outcome measures were not analyzed.||||||
2669390|NCT01495988|Secondary|Toxicity and Safety Profile|Describe the toxicity and safety profile of treatment with vemurafenib/cobimetinib versus vemurafenib/cobimetinib and bevacizumab in patients with stage IV, BRAFV600E/K melanoma.|Until study completion|The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.||||||
2669391|NCT01495988|Secondary|Response Rates|Compare response rate (RR) of patients with stage IV, BRAFV600E/K melanoma treated with vemurafenib/cobimetinib versus vemurafenib/cobimetinib and bevacizumab.|From time of randomization to time of disease progression (restaging for tumor response to occur every 8 wks until wk 48, then every 12 wks thereafter)|The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.||||||
2669392|NCT01495988|Secondary|Overall Survival|Compare overall survival (OS) of patients with stage IV, BRAFV600E/K melanoma treated with vemurafenib/cobimetinib versus vemurafenib/cobimetinib and bevacizumab.|Time between randomization and death due to any cause (overall survival rates also to be assessed at 12 and 18 months)|The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.||||||
2669393|NCT01495988|Primary|Median Progression-free Survival|To compare median progression-free survival (PFS) of patients with stage IV, BRAFV600E or BRAFV600K melanoma treated with vemurafenib/cobimetinib versus vemurafenib/cobimetinib and bevacizumab.|Time between randomization and disease progression (~10-15 months)|The trial was terminated prematurely during the phase Ib safety lead-in and outcome measures were not analyzed due to significantly underpowered data and the MTD being undetermined.||||||
2669399|NCT01495923|Secondary|Proceeded to Surgery Within Year of Enrollment|This is a measure of participants that proceeded to surgery within a year of enrollment|Measured within the year of enrollment in the study|Data for this outcome measure was collected one year following the last follow-up. Data was not available for one participant in the epidural steroid injection arm and for three in the gabapentin arm.|||Participants|||Count of Participants
2669400|NCT01495923|Secondary|Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale|This outcome measure compares the worst back pain at baseline to the worst back pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|3 months after the start of treatment||||units on a scale||Standard Deviation|Mean
2669401|NCT01495923|Secondary|Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale|This outcome measure compares the worst back pain at baseline to the worst back pain at 1 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|1 month from the start of treatment||||units on a scale||Standard Deviation|Mean
2669402|NCT01495923|Secondary|Global Perceived Effect of Treatment at 1 Month After the Start of Treatment|"The participant is asked Are you satisfied with the treatment you have received so far? Participants could respond yes or no. This is measured 1 month after the start of treatment."|1 month after the start of treatment||||Participants|||Count of Participants
2669403|NCT01495923|Secondary|Global Perceived Effect of Treatment at 3 Months After the Start of Treatment|"The participant is asked Are you satisfied with the treatment you have received so far? Participants could respond yes or no. This is measured 3 months after the start of treatment."|3 months after the start of treatment||||Participants|||Count of Participants
2669404|NCT01495923|Secondary|Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index|Functional capacity measured using Oswestry disability index. The range of possible scores for Oswestry Disability Index are 0-100. 0 is equated with no disability and 100 is the maximum disability possible.|3 months after the start of treatment||||participants||Standard Deviation|Mean
2669405|NCT01495923|Secondary|Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index|Functional capacity measured using Oswestry disability index. The range of possible scores for Oswestry Disability Index are 0-100. 0 is equated with no disability and 100 is the maximum disability possible.|1 month after the start of treatment||||units on a scale||Standard Deviation|Mean
2669406|NCT01495923|Secondary|Average Back Pain at 3 Months Measured Using the Numeric Pain Scale|This outcome measure compares the average back pain at baseline to the average back pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|3 months from the start of treatment||||units on a scale||Standard Deviation|Mean
2669407|NCT01495923|Secondary|Average Back Pain at 1 Month Measured Using the Numeric Pain Scale|This outcome measure compares the average back pain at baseline to the average back pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|1 month fromt he start of treatment||||units on a scale||Standard Deviation|Mean
2669408|NCT01495923|Primary|Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale|This outcome measure compares the worst leg pain at baseline to the worst leg pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|3 months from the start of treatment||||units on a scale||Standard Deviation|Mean
2669409|NCT01495923|Primary|Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale|This outcome measure compares the average leg pain at baseline to the average leg pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|1 month from the start of treatment||||units on a scale||Standard Deviation|Mean
2669410|NCT01495923|Primary|Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale|This outcome measure compares the average leg pain at baseline to the average leg pain 3 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|3 months from the start of treatment||||units on a scale||Standard Deviation|Mean
2669411|NCT01495923|Primary|Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale|This outcome measure compares the average leg pain at baseline to the average leg pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group.|1 month after the start of treatment||||units on a scale||Standard Deviation|Mean
2669412|NCT01495858|Other Pre-specified|Vital Signs: Mean Change From Baseline in Respiratory Rate at Day 2||Baseline and day 2|Safety Population|||Breaths/min||Standard Deviation|Mean
2669413|NCT01495858|Other Pre-specified|Vital Signs: Mean Change From Baseline in Pulse Rate at Day 2||Baseline and day 2|Safety Population|||Beats/min||Standard Deviation|Mean
2669414|NCT01495858|Other Pre-specified|Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure at Day 2||Baseline and Day 2|Safety Population|||mmHg||Standard Deviation|Mean
2669415|NCT01495858|Other Pre-specified|Vital Signs: Mean Change From Baseline in Systolic Blood Pressure at Day 2||Baseline and day 2|Safety Population|||mmHg||Standard Deviation|Mean
2669416|NCT01495858|Secondary|Global Assessment of Investigational Product as a Pain Reliever|The Global Assessment of Investigational Product as a Pain Reliever was a 5- point categorical scale which included the following possible responses: poor (0); fair (1); good (2); very good (3); excellent (4).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2669419|NCT01495858|Secondary|Overall Rating of Pain Relief|"The Pain Relief Rating Scale was a 5-point categorical scale which included the following possible responses to the request to finish statement Overall, the relief from my starting pain was: no relief (0); a little relief (1); some relief (2); a lot of relief (3); complete relief (4)."|Up to 10 hours|ITT (Intent to Treat) Population|||Participants|||Number
2669420|NCT01495858|Secondary|Change From Baseline in Pain Intensity|Pain Severity was collected on a 4-point categorical scale: 0=no pain, 1=mild pain, 2=moderate pain, 4=severe pain|Baseline and up to 10 hours|ITT (Intent to Treat) Population|||Scores on a scale||Standard Deviation|Mean
2669421|NCT01495858|Secondary|Subjective Sleep Questionnaire - Number of Minutes You Think That You Were Awake From the Time You Fell Asleep Until the Time You Got Out of Bed|Subjects responded to Estimate of the amount of time the subject was awake from the time he or she fell asleep until the time he or she got out of bed (hours and minutes)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Minutes||Standard Deviation|Mean
2669422|NCT01495858|Secondary|Subjective Sleep Questionnaire - Time to Fall Asleep Last Night|Subjects responded to Estimate of how long it took to fall asleep (minutes)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Minutes||Standard Deviation|Mean
2669423|NCT01495858|Secondary|Subjective Sleep Questionnaire - Refreshing Nature of Your Sleep Last Night|Subjects responded to Refreshing nature of sleep (10-point scale, where 1 was not refreshing and 10 was very refreshing)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Scores on a scale||Standard Deviation|Mean
2669424|NCT01495858|Secondary|Subjective Sleep Questionnaire - Quality of Your Sleep Last Night|Subject evaluated sleep quality on a 10-point scale, where 1 was poor and 10 was excellent.|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Scores on a scale||Standard Deviation|Mean
2669425|NCT01495858|Secondary|Karolinska Sleep Diary - Sufficient Sleep|Subjects responded to the following question: Did you get enough (sufficient) sleep? no, definitely too little (1); no, much too little (2); no, somewhat too little (3); yes, almost enough (4); yes, definitely enough (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2669426|NCT01495858|Secondary|Karolinska Sleep Diary - Well Rested|Subjects responded to the following question: Well Rested? not rested at all (1); somewhat unrested (2); completely rested (3)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2669427|NCT01495858|Secondary|Karolinska Sleep Diary - Ease of Awakening|Subjects responded to the following question: Ease of awakening? (1) very difficult; (2) rather difficult; (3) neither difficult nor easy; (4) rather easy; very easy (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2669428|NCT01495858|Secondary|Karolinska Sleep Diary - Premature Awakening|Subjects responded to the following question : Premature awakening? woke up much too early (1); woke up somewhat too early (2); no (3)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2669429|NCT01495858|Secondary|Karolinska Sleep Diary - Easiness to Fall Asleep|Subjects responded to the following question: How easy was it to fall asleep? very difficult (1); rather difficult (2); neither difficult nor easy (3); rather easy (4); very easy (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2669430|NCT01495858|Secondary|Karolinska Sleep Diary - Calmness of Sleep|Subjects responded to the following question: How calm was your sleep? very restless (1); rather restless (2); neither restless nor calm (3); rather calm (4); very calm (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2669431|NCT01495858|Secondary|Karolinska Sleep Diary - Sleep Quality|Subjects responded to the following question: How was your sleep? very poor (1); rather poor (2); neither poor nor good (3); rather good (4); very good (5)|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2669432|NCT01495858|Secondary|Global Assessment of Investigational Product as a Sleep Aid|The Global Assessment of Investigational Product as a Sleep-Aid was rated using a 5-point categorical scale for which the potential response was poor (0), fair, (1), good (2), very good (3), or excellent (4).|Up to 10 hours|ITT (Intent to Treat) Population with available data (missing values were not imputed)|||Participants|||Number
2669433|NCT01495858|Secondary|Sleep Efficiency Measured by Actigraphy|Sleep efficiency was calculated as (total sleep time/total time in-bed time) × 100; total in-bed time was fixed at 10 hours. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Percent of sleep time during in-bed time||95% Confidence Interval|Least Squares Mean
2669434|NCT01495858|Secondary|Total Sleep Time Measured by Actigraphy|Total time spent sleeping (not to exceed 600 minutes) during the in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Least Squares Mean
2669435|NCT01495858|Primary|Sleep Latency Measured by Actigraphy|Sleep latency was defined as the time to sleep onset from the time of dosing as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Median
2669436|NCT01495858|Primary|Wake Time After Sleep Onset (WASO) Measured by Actigraphy|WASO was defined as Total wake time (in minutes) after sleep onset during the 10 hours in-bed period as measured by actigraphy. Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects.|Up to 10 hours|ITT (Intent to Treat) Population|||Minutes||95% Confidence Interval|Least Squares Mean
2671146|NCT01479478|Secondary|Neonatal C-reactive Protein Level|Maximum neonatal C-reactive protein level|Up to 14 days following delivery|Participants with available data were included in the analysis.|||mg/L||Inter-Quartile Range|Median
2669437|NCT01495793|Primary|Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 3 mg/24 h (15 cm^2)|"VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.|||L (Liter)||95% Confidence Interval|Least Squares Mean
2669438|NCT01495793|Primary|Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 2 mg/24 h (10 cm^2)|"VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.|||L (Liter)||95% Confidence Interval|Least Squares Mean
2669439|NCT01495793|Primary|Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 1 mg/24 h (5 cm^2)|"VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.|||L (Liter)||95% Confidence Interval|Least Squares Mean
2669440|NCT01495793|Primary|Volume of Distribution at Steady State (VSS/f) of Unconjugated Rotigotine 0.5 mg/24 h (2.5 cm^2)|"VSS/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.|||L (Liter)||95% Confidence Interval|Least Squares Mean
2669441|NCT01495793|Primary|Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 3 mg/24 h (15 cm^2)|"CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.|||L/h (Liter per hour)||95% Confidence Interval|Least Squares Mean
2669442|NCT01495793|Primary|Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 2 mg/24 h (10 cm^2)|"CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.|||L/h (Liter per hour)||95% Confidence Interval|Least Squares Mean
2669443|NCT01495793|Primary|Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 1 mg/24 h (5 cm^2)|"CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.|||L/h (Liter per hour)||95% Confidence Interval|Least Squares Mean
2669444|NCT01495793|Primary|Apparent Total Body Clearance (Cl/f) of Unconjugated Rotigotine 0.5 mg/24 h (2.5 cm^2)|"CL/f was calculated for each subject treated with rotigotine derived from the concentrations of unconjugated rotigotine measured in plasma.~For the primary variables the parametric point estimator for each dose step and the 95% CI was calculated using the least-squares (LS) means and the root mean square of error from the ANOVA of the log-transformed data with subsequent exponential transformation."|0 h (predose), 1 h, 2 h, 7-12 h and 22-24 h on Day 7, 14, 21 and 28|The Pharmacokinetic Per Protocol Set (PKPPS) includes all enrolled subjects who were included in the Safety Set, who had no protocol deviations that were considered to impact the subject's validity for analysis of the primary study objective and who for at least 1 dose step fulfilled specific predefined conditions.|||L/h (liter per hour)||95% Confidence Interval|Least Squares Mean
2669445|NCT01495702|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with available data while on study drug were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||cells/µL||Standard Deviation|Mean
2669446|NCT01495702|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||cells/µL||Standard Deviation|Mean
2669447|NCT01495702|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 96|Full Analysis Set|||percentage of participants|||Number
2669448|NCT01495702|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 48|Full Analysis Set: participants were randomized, received at least 1 dose of study drug, had no documented resistance, and were on an NNRTI at screening|||percentage of participants|||Number
2669449|NCT01495689|Secondary|Rate of Recruitment and Retention|Rate of recruitment and retention will be evaluated which will inform feasibility of a larger trial|6 months|||||||
2669450|NCT01495689|Secondary|Cost-effectiveness Analysis|We will measure direct and indirect costs of the intervention and perform cost-effectiveness analysis of the intervention provided in the out-patient setting with a dedicated nurse available to deliver the intervention.|6 months|||||||
2669451|NCT01495689|Primary|Biochemically Confirmed (Exhaled CO ≤ 10 Ppm) Self-reported Continuous Abstinence at 26 Weeks.|The primary outcome will be measured at 26 weeks: (1) bio-chemically confirmed 7-day point prevalence abstinence; and (2) self reported continuous abstinence since randomization. Participants who will not be available for follow-up will be considered smokers. At the 26 week follow-up, all patients who report being abstinent from smoking will have their smoking status confirmed by measurement of a CO sample. If any CO will be >10 ppm, the subject will be considered a smoker.|6 months||||Participants|||Count of Participants
2669452|NCT01495585|Secondary|ALT Levels||7 months||||U/L||Standard Deviation|Mean
2669453|NCT01495585|Primary|Change in Quantitative Serum HDV RNA Levels After 28 Days of Lonafarnib Therapy.||28 days||||log(IU/ml)||Standard Deviation|Mean
2669454|NCT01495572|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|10 months||||participants|||Number
2669455|NCT01495572|Primary|Clinical Tumor Response|Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response (PR) is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.|One year||||participants|||Number
2669456|NCT01495481|Secondary|Number of Participants With Hypotension by Non-invasive Cuff in First 10 Minutes After Medication Administration|Blood pressure changes after dexmedetomidine vs. adenosine. Blood pressure measured by non-invasive cuff prior to medication administration, and then at 1 min, 3 min, 5 min after medication administration. Number of participants with a significant drop in blood pressure (mmHg) compared to baseline would be counted for hypotension.|10 minutes||||participants|||Number
2669457|NCT01495481|Secondary|Number of Participants With Tachyarrhythmias After Medication Administration|Number of participants with tachyarrhythmias, including Ventricular (Ventricular Tachycardia & Fibrillation)and supraventricular (Atrial Flutter & Fibrillation) after dexmedetomidine vs. adenosine administration|10 minutes||||participants|||Number
2669458|NCT01495481|Secondary|Number of Participants With Sinus Pause >2.5 Sec After Termination of SVT|Evaluation of the number of participants with sinus pause > 2.5 sec, after dexmedetomidine vs. adenosine induced SVT termination|1 minute||||participants|||Number
2669459|NCT01495481|Primary|Termination of SVT|Number of participants with SVT Termination within 3 minutes of medication administration|Within 3 minutes||||participants|||Number
2669460|NCT01495286|Secondary|Skin Assessment|Areas of skin where the Stim Care electrodes are placed will be assessed for redness, tenderness, or any other change in skin condition. Assessment will take place at baseline, after the NESAP procedure, upon discharge from the hospital, and after one week. If there is a problem at one week, there will be additional follow-up at two weeks.|Post procedure monitoring for the duration of the hospital stay, an expected average of 1 day. Follow up phone calls at one week and again at two weeks if needed.|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants,we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one sided paired t test|||participants|||Number
2669461|NCT01495286|Secondary|Pain During TENS Treatment and Routine Heel Stick|Pain scores were measured using the Premature Infant Pain Profile (PIPP). The PIPP is a composite pain tool that measures pain based on behavioral and physiologic parameters and adjusts for gestational age. Differences in pain scores were recorded throughout the heel stick process, using a baseline score as reference. Mean pain scores were calculated before NESAP (baseline), after the TENS unit was turned on, after ten minutes of NESAP but before heel stick, during heel cleaning, during the initial heel stick, during heel squeeze, and during recovery. For term infants, the range of PIPP scores is on a scale of 0 for no pain to 18 for severe pain. A score of 6 indicate mild pain, and a score of 11 -12 indicates moderate pain. An increase in PIPP score of 4 or greater from baseline indicates a significant change in pain level.|Pain score given during the heel stick process and for 2 minutes afterwards|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants, we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one-sided paired t-test.|||units on a scale||Standard Deviation|Mean
2669462|NCT01495286|Secondary|Blood Pressure During TENS Treatment and Heel Stick|Changes in systolic and diastolic blood pressure after initial baseline. Measurements will be taken at baseline, after 5 minutes of NESAP, at 5 minutes after end of heel stick, and upon return to infant's room.|Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants, we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one-sided paired t-test.|||mm Hg||Standard Deviation|Mean
2669463|NCT01495286|Primary|Oxygen Saturation During Treatment With TENS Unit and Routine Heel Stick|Changes in oxygen saturation after an initial baseline oxygen saturation. Oxygen saturation will be measured after TENS unit is initiated, for 10 minutes between TENS initiation and heel stick,during heel stick, and for 5 minutes afterwards. Measurements will be taken at baseline, after 5 minutes of NESAP, and at 5 minutes after end of heel stick.|Baseline, duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant increase in pain level. With 30 infants, we had 90% power to detect a significant increase in PIPP score with a .05 level, one-sided paired t-test.|||percentage of oxygen saturation||Standard Deviation|Mean
2669464|NCT01495286|Primary|Heart Rate During Treatment With TENS Unit|Changes in heart rate will be recorded after an initial baseline heart rate. Heart rate will be taken at baseline, after 5 minutes of NESAP, at 5 minutes after end of heel stick, and upon return to infant's room.|Duration of the TENS unit treatment and heel stick, an expected average of 20 minutes.|We based power analysis on 90% power for detecting that the PIPP score had increased by 4, indicating a significant change. With 30 infants, we had 90% power for detecting whether the pain score (PIPP) had increased significantly when testing with a .05 level, one-sided paired t-test.|||beats per minute||Standard Deviation|Mean
2669465|NCT01495221|Secondary|Mean Change in OCT Greatest Height of Pigment Epithelial Detachment From Baseline to Week 16|OCT is performed on the Spectralis spectral domain OCT machine (Heidelberg Engineering, Germany). The OCT is centered on the fovea. The OCT examination will use the 19 scan mode on the Spectralis averaging at least 25 images per scan. Follow-up visits will use the follow-up protocol on the Spectralis , automatically placing follow-up scans in precisely the same location as the baseline scan.|Baseline and 16 weeks|The average age of enrollment is 74 years old with first treatment for CNV at 18.5 months.|||microns||Full Range|Mean
2669466|NCT01495221|Secondary|Mean Change in OCT Central Retinal Lesion Thickness From Baseline to Week 16|OCT is performed on the Spectralis spectral domain OCT machine (Heidelberg Engineering, Germany). The OCT is centered on the fovea. The OCT examination will use the 19 scan mode on the Spectralis averaging at least 25 images per scan. Follow-up visits will use the follow-up protocol on the Spectralis , automatically placing follow-up scans in precisely the same location as the baseline scan.|Baseline and week 16|The average age of enrollment is 74 years old with first treatment for CNV at 18.5 months.|||Microns||Full Range|Mean
2669467|NCT01495221|Primary|Mean Change in Visual Acuity From Baseline to Week 16|Visual acuity was documented via BCVA at every study visit.|Baseline to Week 16|The average age of enrollment is 74 years old with first treatment for CNV at 18.5 months.|||letters||Standard Deviation|Mean
2669468|NCT01495221|Primary|Proportion of Patients With no Fluid on OCT at Week 24|No primary outcome data can be found or provided.|24 week|Patients analyzed is zero due to no outcome data was collected at week 24 due to early termination of the clinical study.||||||
2669469|NCT01495000|Secondary|Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 6|The number of participants with positive and negative results for both neutralizing antibodies to denosumab and for binding antibodies to denosumab at Month 6 are summarized.|Month 6|ITT Population. Only participants available at the specified time point were analyzed.|||participants|||Number
2669470|NCT01495000|Secondary|Change From Baseline in Red Cell Distribution Width at Month 6|Blood samples were collected for the measurement of red cell distribution width values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.|||percentage||Standard Deviation|Mean
2669471|NCT01495000|Secondary|Change From Baseline in Red Blood Cell Count at Month 6|Blood samples were collected for the measurement of red blood cell count values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
2669472|NCT01495000|Secondary|Change From Baseline in Mean Corpuscular Volume at Month 6|Blood samples were collected for the measurement of mean corpuscular volume values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.|||femtoliters||Standard Deviation|Mean
2669473|NCT01495000|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at Month 6|Blood samples were collected for the measurement of hemoglobin values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.|||picograms||Standard Deviation|Mean
2669474|NCT01495000|Secondary|Change From Baseline in Hematocrit at Month 6|Blood samples were collected for the measurement of hematocrit values. Change from Baseline was calculated as the Month 6 value minuse the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.|||proportion of RBCs in blood||Standard Deviation|Mean
2669475|NCT01495000|Secondary|Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, and Very Low-density Lipoproteins (VLDL) Cholesterol Calculation at Month 6|Blood samples were collected for the measurement of calcium corrected, calcium, chloride, glucose, potassium, magnesium, sodium, phosphorus inorganic, triglyceride, urea/BUN, and VLDL cholesterol calculation values. Change from Baseline was calcualted as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.|||millimoles per liter (MMOL/L)||Standard Deviation|Mean
2669476|NCT01495000|Secondary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Month 6|Blood samples were collected for the measurement of direct bilirubin, indirect bilirubin, total bilirubin, creatinine, and uric acid values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.|||micromoles per liter (UMOL/L)||Standard Deviation|Mean
2669477|NCT01495000|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Total Neutrophils, Platelet Count, and White Blood Cell Count Month 6|Blood samples were collected for the measurement of basophil, eosinophil, lymphocyte, monocyte, segmented neutrophil, total neutrophil, platelet count, and white blood cell count values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
2669478|NCT01495000|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase, and Lactate Dehydrogenase at Month 6|Blood samples were collected for the measurement of alkaline phosphatase, alanine amino transferase, aspartate amino transferase, creatinine kinase, gamma glutamyl transferase, and lactate dehydrogenase values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.|||International units per liter (IU/L)||Standard Deviation|Mean
2669479|NCT01495000|Secondary|Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin Concentration (Conc.), and Total Protein at Month 6|Blood samples were collected for the measurement of albumin, hemoglobin, mean corpuscle hemoglobin concentration, and total protein values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.|||grams per liter (g/L)||Standard Deviation|Mean
2669480|NCT01495000|Secondary|Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6|Blood samples were collected for the measurement of albumin/globulin ratio and BUN/creatinine ratio values. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants available at the specified time points were analyzed.|||ratio||Standard Deviation|Mean
2669481|NCT01495000|Secondary|Number of Participants With the Indicated Laboratory Parameter Values of Potential Clinical Concern at Month 6|The number of participants with laboratory parameter values of potential clinical concern at Month 6 are summarized. The following are the laboratory values of potential clinical concern: alkaline phosphatase, High: >375 units/Liter (L); aspartate aminotransferase, High: >165 units/L; creatinine, High: >159 micromoles (µmol)/L; glucose, Low: <3 millimoles (mmol)/L; hematocrit, Low: <0.325; hemoglobin, Low: <91grams/L; phosphorus, High: >1.723 mmol/L; potassium, High: >6.3 mmol/L; sodium, Low: <130 mmol/L; total neutrophils, Low: <0.9 10^9 cells (GI)/L; blood urea nitrogen (BUN), High: >21mmol/L; uric acid, High: 654 µmol/L.|Month 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.|||participants|||Number
2669482|NCT01495000|Secondary|Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Months 1, 3, and 6|"Vital sign values of potential clinical concern were defined as: change in heart rate >30 beats per minutes (bpm), change in systolic blood pressure (SBP) >30 millimeters of mercury (mmHg), and change in diastolic blood pressure (DBP) >20 mmHg. The number of participants with post-Baseline vital sign values of potential clinical concern who did not have values of potential clinical concern at Baseline are summarized. If the change from Baseline is a decrease greater than the threshold, it is categorized as low. If the change from Baseline is an increase greater than the threshold, it is categorized ad high."|Baseline; Months 1, 3, and 6|ITT Population. Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects the entire ITT Population.|||participants|||Number
2669483|NCT01495000|Secondary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment was to have been exercised in other important medical events. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline up to Month 6|ITT Population: all participants who received one dose of study medication|||participants|||Number
2669496|NCT01494818|Secondary|Median Non-Invasive Pre-Lens Tear Film Break Up Time (PL-NIBUT)|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eyelid and the contact lens). The time required for a dry spot to appear on the pre-lens surface after blinking is referred to as the pre-lens tear film break up time. PL-NIBUT was evaluated using a biomicroscope with a diffuse illumination source, i.e., Tearscope. A longer PL-NIBUT indicates a more stable tear film and greater on-eye lens wettability. Three PL-NIBUT measurements were recorded, and the median value was used for analysis. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol|||Seconds||Standard Deviation|Mean
2669484|NCT01495000|Secondary|Median Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type IN Propeptide (s-PINP) Markers at Months 1, 3, and 6|Blood samples were collected for the measurement of s-CTx and s-PINP, which are used as biomarkers of bone resorption and formation, respectively. The median percent change from Baseline in s-CTX and s-PINP markers at Months 1, 3, and 6 was calculated as: (post-Baseline value minus Baseline value) * 100 / Baseline value.|Baseline; Months 1, 3, and 6|ITTE Population. Only participants with s-CTX and s-PINP values at both Baseline and Months 1, 3, and 6 were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects the entire ITTE Population.|||percent change||Inter-Quartile Range|Median
2669485|NCT01495000|Secondary|Mean Percent Change From Baseline in BMD at the Total Hip, Femoral Neck, and Trochanter at Month 6|BMD at the total hip, femoral neck, and trochanter was measured by the DXA scanner. The mean percent change from Baseline in BMD was calculated as: (value at Month 6 minus Baseline value) * 100 / Baseline value. Analysis was performed using an ANCOVA model with terms for treatment and corresponding Baseline BMD (as a continuous covariate).|Baseline and Month 6|ITTE Population. Only participants with BMD values at both Baseline and Month 6 were analyzed.|||percent change||Standard Error|Least Squares Mean
2669486|NCT01495000|Primary|Mean Percent Change From Baseline in Bone Mineral Density at the Lumbar Spine at Month 6|Bone mineral density (BMD) at the lumbar spine was measured by the dual-energy x-ray absorptiometry (DXA) scanner. The mean percent change from Baseline in BMD was calculated as: (value at Month 6 minus Baseline value) * 100 / Baseline value. Analysis was performed using an Analysis of Covariance (ANCOVA) model with terms for treatment and baseline BMD at the lumbar spine (as a continuous covariate).|Baseline and Month 6|Intent-to-Treat Efficacy (ITTE) Population: all randomized participants who received one dose of study medication, and who had a Baseline measure and at least one post-Baseline efficacy measure during the Double-blind Treatment Phase. Only participants with BMD values at both Baseline and Month 6 were analyzed.|||percent change||Standard Error|Least Squares Mean
2669487|NCT01494987|Secondary|Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24|The average (mean) change from baseline in 2-hour postprandial serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the MMTT Full Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
2669488|NCT01494987|Secondary|Change From Baseline in Fasting Serum Glucose at Week 24|The average (mean) change from baseline in fasting serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
2669489|NCT01494987|Secondary|Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24|"The average (mean) change from baseline in incremental change of 2-hour postprandial serum glucose at Week 24 was analyzed.~Mixed Meal Tolerance Test (MMTT) Full Analysis Set: randomized participants who received at least one dose of study treatment with a baseline and at least one postbaseline measurement of serum glucose at T=120 minutes during the MMTT, administered under fasting conditions, excluding participants with major eligibility protocol violations, analyzed based on the randomized treatment regardless of actual treatment received."|Baseline; Week 24|Participants in the Mixed Meal Tolerance Test (MMTT) Full Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
2669490|NCT01494987|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|The average (mean) change from baseline in HbA1c at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set (randomized participants who received ≥ 1 dose of study treatment with a baseline and at least one postbaseline measurement of HbA1c, excluding participants with major eligibility violations and analyzed based on randomized treatment, regardless of actual treatment received) with available data were analyzed.|||percent of HbA1c in blood||Standard Deviation|Mean
2669491|NCT01494818|Secondary|Total Lipid Uptake Per Lens|The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value would indicate a cleaner lens surface.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol|||micrograms||Standard Deviation|Mean
2669492|NCT01494818|Secondary|Median Front Lens Deposits|Deposits present on the front surface of the lens were assessed with a biomicroscope while the lens was on eye. Deposits were rated on a 5-point forced choice scale (0 = none; 1 = slight; = mild; 3 = moderate; 4 = severe) in five lens zones. The median of the five zones was used for analysis. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol|||Units on a scale||Full Range|Median
2669493|NCT01494818|Secondary|Protective Index|A digital video recording was made of the interblink period. The percentage of area of the visible contact lens covered by the tear film was calculated (Protected Area). The Protective Index is defined as the average tear coverage over the whole interblink period. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol|||Percent of visible contact lens surface||Standard Deviation|Mean
2669494|NCT01494818|Primary|Change From Baseline in Upper Eyelid Margin Staining at Month 3|The contact lens was removed and ophthalmic dye was instilled. Upper eyelid margin staining was objectively measured through digital images. The extent of true staining (i.e., the total area of lid margin covered by staining) was recorded. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol|||square millimeters||Standard Deviation|Mean
2669495|NCT01494818|Primary|Upper Lid Redness|The contact lenses were removed and upper lid redness was objectively measured through digital images. The coverage of the palpebral surface by blood vessels is expressed as percentage of the total surface measured. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol|||Percentage of total surface measured||Standard Deviation|Mean
2669497|NCT01494818|Primary|Maximum Eyelid Hyperaemia|Eyelid hyperaemia (redness) was recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = Clear; 1 = Slight redness; 2 = Mild redness; 3 = Moderate redness; 4 = Severe redness). The maximum value represents the worst grade in any zone. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol|||Units on a scale||Full Range|Median
2669498|NCT01494818|Primary|Maximum Papillae|Eyelid papillae (bumps on the inner eyelid) were recorded separately for three zones of the upper lid and overall for the lower lid on a 5-point forced choice scale (0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum value represents the worse grade in any zone. Both eyes were included in the model for analysis.|Baseline, Month 3|All enrolled and dispensed participants who completed the study as per protocol|||Units on a scale||Full Range|Median
2669499|NCT01494753|Primary|Mean Intra Ocular Pressure (IOP) at 8.00am|Efficacy criteria at 8.00am on Day 42 and on Day84. Worse Eye= the eligible eye (with at least one out of the 4 individual IOP values on Day 0 >= 22 and <=30mmHg) with the highest individual IOP at 8.00am on Day 0. If both eyes are eligible and have the same individual IOP at 8.00am on Day 0, the right eye is considered.|Day 42 and Day 84 (8.00am for the IOP)|Per protocol (PP) set: All patients enrolled in the study for whom any follow-up efficacy information was evaluable and who did not show any major protocol deviation that could affect the efficacy assessment.|||mmHg||Standard Deviation|Mean
2669500|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 14 minus mean score at baseline.|Baseline and Day 14|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.|||units on a scale||95% Confidence Interval|Mean
2669501|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 3 minus mean score at baseline.|Baseline and Day 3|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.|||units on a scale||95% Confidence Interval|Mean
2669502|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment|Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score immediately after treatment minus mean score at baseline.|Baseline and immediately after treatment administration|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.|||units on a scale||95% Confidence Interval|Mean
2669503|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 14 minus Schiff score at baseline.|Baseline and Day 14|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.|||units on a scale||95% Confidence Interval|Mean
2669504|NCT01494649|Secondary|Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 3 minus Schiff score at baseline.|Baseline and Day 3|ITT population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.|||units on a scale||95% Confidence Interval|Mean
2669505|NCT01494649|Primary|Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment|Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity).0= no response; 1= response and no discontinuation request; 2= response and discontinuation request; 3= painful response and discontinuation request. Change was calculated as Schiff score immediately after treatment minus Schiff score at baseline.|Baseline and immediately after treatment administration|Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.|||units on a scale||95% Confidence Interval|Mean
2669506|NCT01494610|Secondary|Number of Participants With an Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Randomization (Day 1) up to Follow-up (Days 47-50)|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
2669507|NCT01494610|Secondary|Mean Calcium, Chloride, Glucose, Potassium, Sodium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicar), and Urea/Blood Urea Nitrogen (BUN)|"Blood samples of participants were collected for the evaluation of calcium, chloride, glucose, potassium, sodium, carbon dioxide (CO2) content/bicarbonate, and urea/BUN. All of these parameters are measured to help assess the condition of the kidneys. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||µmol/L||Standard Deviation|Mean
2669508|NCT01494610|Secondary|Mean Direct Bilirubin (DB), Total Bilirubin (TB), Creatinine, and Uric Acid|"Blood samples of participants were collected for the evaluation of DP, TB, creatinine, and uric acid. DB and TB are measures that help assess the condition of the liver, and creatinine and uric acid are measures that help assess the condition of the kidneys. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2669509|NCT01494610|Secondary|Mean Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST), and Gama Glutamyl Transferase (GGT)|"Blood samples of participants were collected for the evaluation of AP, ALT, AST, and GGT. All of these parameters are measured to help assess the condition of the liver. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||International units per liter (IU/L)||Standard Deviation|Mean
2669510|NCT01494610|Secondary|Mean Albumin and Total Protein|"The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||g/L||Standard Deviation|Mean
2669511|NCT01494610|Secondary|Mean Hematocrit|"Blood samples of participants were collected for the evaluation of hematocrit. The hematocrit is the percentage of the RBCs in the blood. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||percentage of RBCs||Standard Deviation|Mean
2669512|NCT01494610|Secondary|Mean Corpuscle Volume (MCV)|"Blood samples of participants were collected for the evaluation of MCV. MCV is a measure of the average red blood cell size that is reported as part of a standard complete blood count. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||Femtoliters (fL; 10^-15 L)/cell||Standard Deviation|Mean
2669513|NCT01494610|Secondary|Mean Corpuscule Hemoglobin (MCH)|"Blood samples of participants were collected for the evaluation of MCH. MCH is the average mass or amount of hemoglobin per red blood cell in a sample of blood. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subject Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||picograms (pg)/cell||Standard Deviation|Mean
2669514|NCT01494610|Secondary|Red Blood Cell (RBC) Count and Reticulocytes|"Blood samples of participants were collected for the evaluation of RBC and reticulocytes count. Reticulocytes are immature red blood cells. Normally, about 1% to 2% of the red blood cells in the blood are reticulocytes. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||Trillion (10^12) cells/L||Standard Deviation|Mean
2669632|NCT01494051|Secondary|Body Composition|does body composition change more among subjects randomized to the high protein diet compared to the high carbohydrate diet? We measured body composition at baseline and again at the end of the study by DEXA - dual energy x-ray absorptiometry.|change from baseline to 4 months of treatment||||change in kg||Standard Deviation|Mean
2669515|NCT01494610|Secondary|Mean Hemoglobin and Mean Corpuscular Hemoglobin (MCH) Concentration|"Blood samples of participants were collected for the evaluation of mean hemoglobin (mean level of hemoglobin in the whole blood sample) and MCH concentration. The MCH concentration is the average concentration of hemoglobin in a red blood cell. Hemoglobin is the red pigment in the blood, and it is reponsible for carrying oxygen. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||Grams per liter (g/L)||Standard Deviation|Mean
2669516|NCT01494610|Secondary|Mean Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, and White Blood Cell (WBC) Count|"Blood samples of participants were collected for the evaluation of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count, and WBC count. Data are reported for the first (1st) and second (2nd) administration (admin) of FP/salmeterol via MDPI or capsule-based inhaler. The timing of the first and second administrations depended on the randomization schedule. If the treatment sequence received was ABBA, then Days 10 and 40, respectively, correspond to the first and second administrations for treatment A."|Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|All Subjects Population: all participants who received at least one dose of study medication. Out of the total population, 34 participants had asthma and 26 participants had COPD. Only those participants contributing data at the indicated time points were analyzed.|||Giga (10^9) cells/L||Standard Deviation|Mean
2669517|NCT01494610|Secondary|Weighted Mean Over 0 to 4 Hours Post Dose and Maximum Plasma Glucose|Blood samples of participants were collected for the evaluation of weighted mean over 0 to 4 hours post dose and the maximum plasma glucose level. Weighted mean was calculated by using all values of plasma glucose at the indicated timepoint contributing to the calculation of the mean but with different weightage.|At pre-morning dose; 30, 60 minutes post-dose (PD); and 2 and 4 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||mmol/L||Standard Deviation|Mean
2669518|NCT01494610|Secondary|Weighted Mean Over 0 to 4 Hours Post Dose of Plasma Potassium and Minimum (Min) Plasma Potassium|Blood samples of participants were collected for the evaluation of weighted mean over 0 to 4 hours post dose and the minimum plasma potassium level. Weighted mean was calculated by using all values of plasma potassium at the indicated timepoint contributing to the calculation of the mean but with different weightage.|At pre-morning dose; 30, 60 minutes post-dose (PD); and 2 and 4 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|Only those participants contributing data at the indicated time points were analyzed.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2669519|NCT01494610|Secondary|Maximum and Weighted Mean Over 0 to 4 Hours Post Dose of the QT Interval Corrected According to Bazett's Formula (QTc[B]) and the QT Interval Corrected According to Fridericia's Formula (QTc[F])|The electrocardiogram (ECG) of the participants was taken, and the maximum and weighted mean of QTc(B) and QTc(F) was measured. Weighted mean was calculated by using all values of QTc(B) and QTc(F) at the indicated timepoint contributing to the calculation of the mean but with different weightage. The ECG helps in the assessment of the condition of the heart. The QT interval gives the measure of the heart rate, and the cQT interval gives the corrected value.|At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 3 and 4 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||Milliseconds (msec)||Standard Deviation|Mean
2669520|NCT01494610|Secondary|Minimum Diastolic Blood Pressure (DBP), Maximum Systolic Blood Pressure (SBP), and Weighted Mean for DBP and SBP Over 0 to 4 Hours Post Dose|The diastolic and systolic blood pressure of the participants was measured. The maximum and minimum observed values from the time of the morning dose on Day 10 to 4 hours post dose were measured for SBP and DBP. The weighted mean value from the time of the morning dose on Day 10 to 4 hours post dose was calculated. Weighted mean was calculated by using all values of DBP and SBP at the indicated timepoint contributing to the calculation of the mean but with different weightage.|At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2669521|NCT01494610|Secondary|Mean of Maximum Heart Rate Over 0 to 4 Hours Post Dose for Salmeterol|The maximum observed value of heart rate was measured from the time of the morning dose on Day 10 to 4 hours post dose.|At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||bpm||Standard Deviation|Mean
2669522|NCT01494610|Secondary|Weighted Mean Over 0 to 4 Hours Post Dose of Heart Rate for Salmeterol|The heart rate (number of heartbeats per unit of time, typically expressed as beats per minute [bpm]) of the participants was monitored for evaluating the weighted mean over the course of 0 to 4 hours post dose. The Capsule-MDPI difference for heart rate was calculated for each participant, and the weighted mean value from the time of the morning dose on Day 10 to 4 hours post dose was calculated. The weighted mean was calculated by using all values at the indicated timepoint contributing to the calculation of the mean but with different weightage.|At pre-morning dose; 15, 30, 60, 90 minutes post-dose (PD); and 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||bpm||Standard Deviation|Mean
2669559|NCT01494584|Primary|Apparent Clearance (CL/F) Following Oral Administration of Ezogabine/Retigabine|Clearance (CL/F) is defined as dose/AUC(0-tau). Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate CL/F.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|Pharmacokinetic Population|||Liters/Hour||95% Confidence Interval|Geometric Mean
2669523|NCT01494610|Secondary|Serum Cortisol Minimum (Cmin) for FP|Blood samples of participants were collected for the evaluation of minimum serum cortisol. Any differences in systemic exposure as a result of the absorbed steroid component of the two differing inhaled devices should also result in differences in serum cortisol concentrations.|Day 10 of each study period (Periods 1-4); Study Day 10 (+/-1) (reference day is Study Day 1 or Randomization day), Period 1; Study Day 20 (+/-1), Period 2; Study Day 30 (+/-1), Period 3; Study Day 40 (+/-1), Period 4|PK/PD Population|||nmol/L||95% Confidence Interval|Geometric Mean
2669524|NCT01494610|Secondary|Mean Urine Cortisol Excretion Over 0 to 24 Hours Post Dose for FP|Urine samples of participants were collected to evaluate urine cortisol excretion over 0-24 hours post treatment dose. A 24-hour urine cortisol sample was used to measure the total amount of cortisol excreted in urine in 24 hours. Any differences in systemic exposure as a result of the absorbed steroid component of the two differing inhaled devices should also result in differences in the amount of cortisol excreted in the urine.|0-24 hours post dose on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||nmol||95% Confidence Interval|Geometric Mean
2669525|NCT01494610|Secondary|Tmax for Salmeterol|Blood samples of participants were collected for evaluating Tmax. Tmax is a measure of the time required to reach the maximum concentration of the drug.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||hours||Full Range|Median
2669526|NCT01494610|Secondary|Mean Terminal Phase Half-life (t1/2) for Salmeterol|Blood samples of participants were collected for evaluating t1/2. t1/2 is the time required for the plasma/blood concentration of the drug to decrease by 50% after the false equilibrium of distribution has been reached.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population. Only those participants contributing data at the indicated time points were analyzed.|||hours||95% Confidence Interval|Geometric Mean
2669527|NCT01494610|Secondary|Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) for Salmeterol|Blood samples of participants with asthma and COPD were collected and analyzed for Cmax and Cmin of Salmeterol in the blood. Cmax and Cmin are used to estimate the time at which the activity of the drug will be at its maximum and minimum.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||pg/mL||95% Confidence Interval|Geometric Mean
2669528|NCT01494610|Secondary|Time of Occurrence of Cmax (Tmax) for FP|Blood samples of participants were collected for evaluating Tmax. Tmax is a measure of the time required to reach the maximum concentration of the drug.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||hours||Full Range|Median
2669529|NCT01494610|Secondary|Mean Terminal Phase Half-life (t1/2) for FP|Blood samples of participants were collected for evaluating t1/2. The t1/2 is the time required for the plasma/blood concentration of the drug to decrease by 50% after the false equilibrium of distribution has been reached.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population. Only those participants contributing data at the indicated time points were analyzed.|||hours||95% Confidence Interval|Geometric Mean
2669530|NCT01494610|Secondary|Mean Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of FP|Blood samples of participants with asthma and COPD were collected and analyzed for Cmax and Cmin of FP in the blood. Cmax and Cmin are used to estimate the time at which the activity of the drug will be at its maximum and minimum, respectively.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||Picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
2669531|NCT01494610|Secondary|Mean AUC(0-tlast) for FP|Blood samples of participants with asthma and COPD were collected and analyzed for AUC(0-tlast). AUC(0-tlast) is a measure of the plasma drug concentration from pre-dose to the last measurable concentration.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||pg*h/mL||95% Confidence Interval|Geometric Mean
2669532|NCT01494610|Secondary|Mean Plasma AUC(0-tau) and Plasma AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-tlast]) for Salmeterol|Blood samples of participants with asthma and COPD were collected and analyzed for AUC(0-tau) and AUC(0-tlast). AUC(0-tau) is a measure of the amount of drug available at target tissue (in plasma) for a fixed dosing interval (12 hours). AUC(0-tlast) is a measure of the plasma drug concentration from pre-dose to the last measurable concentration.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||pg*h/mL||95% Confidence Interval|Geometric Mean
2669533|NCT01494610|Primary|Weighted Mean Serum Cortisol (SC) Over 0 to 12 Hours Post Dose|Participants' blood samples were collected and analyzed for SC levels. Weighted mean SC levels are evaluted as a measure of the degree of cortisol suppression, allowing for the determination of whether differences in systemic exposure to the inhaled steroid component of two devices can be significant enough to result in the differences in the body's ability to release cortisol. Weighted means were derived by calculating the AUC over the 0-12 hour period, using the linear trapezoidal rule (statistical technique used for numerical analysis) and then dividing it by the actual time interval.|At pre-morning dose; 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|PK/PD Population|||Nanomoles per liter (nmol/L)||95% Confidence Interval|Geometric Mean
2669534|NCT01494610|Primary|Mean Area Under the Concentration Time Curve Over the Dosing Period (AUC[0-tau]) for FP|Blood samples of participants (par.) with asthma and chronic obstructive pulmonary disease (COPD) were collected and analyzed for AUC(0-tau), a measure of the amount of drug available at target tissue (in plasma) for a fixed dosing interval (12 hours). Asthma is a disorder that causes the airways of the lungs to swell and narrow, leading to difficulty in breathing. COPD is a chronic lung disease with structural changes in lungs, leading to difficulty in breathing.|At pre-morning dose; 5, 10, 30 minutes post-dose (PD); and 1, 2, 4, 8, 10, and 12 hours PD on Day 10 of each study period (P): Study Day (SD) 10 (reference day is SD 1 or Randomization day), 20, 30, and 40 (+/-1) for P 1, 2, 3, and 4, respectively|Pharmacokinetic/pharmacodynamic (PK/PD) Population: all participants who received at least one dose of study medication, except for one who was identified as a full protocol violator. Participants with at least one non-missing value in the replicate observations were included.|||Picogram hours per milliliter (pg*h/mL)||95% Confidence Interval|Geometric Mean
2669535|NCT01494584|Secondary|Number of Participants With the Indicated Neurological Abnormality|Abnormal Central Nervous System (CNS) symptoms were assessed by a full and brief neurological examination. A full neurological examination included assessment of mental status, cranial nerves, gait, coordination, sensation, speech/language, muscle strength, muscle tone, and reflexes. A brief neurological examination included assessment of mental status, cranial nerves, gait, coordination, reflexes, and speech/language. Neurological parameters assessed were memory impairment, impaired intellect, decreased attention, psychomotor slowing, decreased muscle strength, hpertonia, somnolence, right and left bicpes, right and left brachioradialis, right and left knee, right and left ankle, and right and left planter response. Neurological examination was performed at Day 7 of Titration 3 (600 mg/day).|Screening and Day 7 of Titration 3 (Day 21)|All Subjects Population|||Participants|||Number
2669536|NCT01494584|Secondary|Change From Baseline in Post Void Residual Ultrasound at Day 21|A post void residual (PVR) bladder ultrasound was carried out as a measure of bladder function. PVR was clinically indicated following the occurrence of adverse events relating to the lower urinary tract (e.g., micturition difficulties, including urinary hesitancy or urinary retention). These assessments were also repeated following drug withdrawal following such events. A prompt follow-up PVR was recommended if a high score was obtained from a participant on the Pediatric Lower Urinary Tract Symptom scale (the PLUTS scale is a clinician-rated scale used to assess lower urinary tract symptoms, including urinary retention) and if the clinician felt that the participant was at risk or had symptoms of urinary retention. PVR was measured at Day 7 of Titration 3 (600 mg/day). Baseline is defined as the Screening visit.|Screening and Day 7 of Titration 3 (Day 21)|All Subjects Population|||ML||Standard Deviation|Mean
2669537|NCT01494584|Secondary|Change From Baseline in Heart Rate (HR)|Vital sign assessment included heart rate measurement and was assessed at Titration 1 (T1; 300 mg/day): Day 1 pre-dose, Day 1 at 3 hours (h), pre-dose and 3 h post-dose. Titration 2 (T2; 450 mg/day): Day 7. Titration 3 (T3; 600 mg/day): pre-dose and 3 h post-dose. Titration 3 Dose Held (T3DH): pre-dose. Titration 4 (T4; 750 mg/day): Day 7. Titration 5 (T5; 900 mg/day): pre-dose and 3 h post-dose. Measurements were taken 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 14 for up-titration to 450 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 28 for up-titration to 750 mg/day dose; Day 35 for up-titration to 900 mg/day dose). Change from baseline was calculated by subtracting the baseline value from the individual post-dose values. Baseline is defined as as the Day 1 pre-dose value.|Baseline (Screening) and Day 7 post up-titration, up to Day 35|All Subjects Population. Only those par. available at the specified time points were analyzed(represented by n=X, X, X, X, X in the category titles). Different par. may have been analyzed at different time points and for different parameters, so the overall number of par. analyzed reflects everyone in the All Subjects Population.|||Beats per Minute (BPM)||Standard Deviation|Mean
2669538|NCT01494584|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points|Vital sign assessment included the measurement of systolic and diastolic blood pressure at Titration 1 (T1; 300 mg/day): Day 1 pre-dose, Day 1 at 3 hours (h), Day 7 pre-dose, and 3 h post dose. Titration 2 (T2; 450 mg/day): Day 7. Titration 3 (T3; 600 mg/day): Day 21 pre-dose and 3 h post-dose. Titration 3 Dose Held (T3DH): pre-dose. Titration 4 (T4; 750 mg/day): Day 7. Titration 5 (T5; 900 mg/day): Day 35 pre-dose and 3 h post-dose. Measurements were taken 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 14 for up-titration to 450 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 28 for up-titration to 750 mg/day dose; Day 35 for up-titration to 900 mg/day dose). Change from baseline was calculated by subtracting the baseline value from the individual post-dose values. Baseline is defined as as the Day 1 pre-dose value.|Baseline (Screening) and Day 7 post up-titration, up to Day 35|All Subjects Population. Only those par. available at the specified time points were analyzed(represented by n=X, X, X, X, X in the category titles). Different par. may have been analyzed at different time points and for different parameters, so the overall number of par. analyzed reflects everyone in the All Subjects Population.|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2669539|NCT01494584|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|An ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected for heart rate (QTc intervals) was used. Measurements were taken 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 14 for up-titration to 450 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 28 for up-titration to 750 mg/day dose; Day 35 for up-titration to 900 mg/day dose). ECG parameters were assessed at Titration 1 (T1; 300 mg/day): Day 1 pre-dose, Day 1 at 3 hours (h), pre-dose, and 3 h post-dose. Titration 2 (T2; 450 mg/day): Day 7. Titration 3 (T3; 600 mg/day): pre-dose and 3 h post-dose. Titration 3 Dose Held (T3DH): pre-dose. Titration 4 (T4; 750 mg/day): Day 7. Titration 5 (T5; 900 mg/day): pre-dose and 3 h post-dose. The number of participants with abnormal (Abn) clinically significant (CS) and not clinically significant (NCS) ECG findings was recorded. The investigator determined if an ECG finding was CS or NCS.|Baseline (Screening) and Day 7 post up-titration, up to Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Participants|||Number
2669626|NCT01494350|Secondary|Number of Index Lesions With Reepithelialization Throughout the Study|Number of index lesions with 100% reepithelialization on Days 28 and 42.|Measured at day 28 and 42|modified intent to treat (mITT). This outcome measure does not include one subject (2 lesions) who withdrew on Day 18.|||lesions|Participants||Number
2669540|NCT01494584|Secondary|Plasma Half Life at Steady State (t1/2) Following Oral Administration of Ezogabine/Retigabine|Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess plasma t1/2. Steady-state t1/2 is derived as (Vd/F) / (CL/F), where Vd/F is defined as the apparent volume of distribution after extravascular (e.g., oral) administration, and CL/F is defined as the apparent clearance following oral dosing.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|PK Population. Only those participants available at the indicated time point were analyzed.|||Hours||95% Confidence Interval|Geometric Mean
2669541|NCT01494584|Secondary|Time to Maximum Concentration (Tmax) Following Oral Administration of Ezogabine/Retigabine|Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess plasma Tmax.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|PK Population|||Hours||Full Range|Median
2669542|NCT01494584|Secondary|Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) for the N-acetyl Metabolite of Ezogabine/Retigabine|Ctau refers to the pre-dose (trough) concentration at the end of the dosing interval which is equivalent to the minimum observed concetration (Cmin) at Steady State. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess the Ctau for n-acetyl metabolite (NAMR) of ezogabine/retigabine following oral administration of ezogabine/retigabine.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|PK Population|||ng/mL||95% Confidence Interval|Geometric Mean
2669543|NCT01494584|Secondary|Area Under the Concentration-time Curve From Time Zero (Pre-dose) to the Last Time of Quantifiable Concentration (AUC [0-t]) for the N-acetyl Metabolite of Ezogabine/Retigabine|The area under the curve was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to assess the plasma n-acetyl metabolite (NAMR) of ezogabine/retigabine following oral administration of ezogabine/retigabine.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|PK Population|||h*ng/mL||95% Confidence Interval|Geometric Mean
2669544|NCT01494584|Secondary|Percent Change From Baseline in 28-day Seizure Frequency Rate|Participants or their caregivers recorded the number of seizures experienced by the participant, by seizure type (e.g., simple partial seizure [seizure that affects only a small region of the brain; consciousness is unaffected], complex partial seizure [seizure associated with unilateral cerebral hemisphere involvement and causing impairment of awareness or responsiveness], etc.), as well as by duration of episodes of innumerable seizure activity, in their daily diaries during all phases of this study. Percent change from baseline is defined as 100 * (rate in a given period minus the baseline rate) / (baseline rate). baseline seizures are defined as those seizures that occurred after Screening and before the start of the treatment. Post-baseline seizures are defined as those seizures that occurred from the start of the treatment until the start of Follow-up. Seizure frequency rate was computed as: 28 * (number of seizures during given period / number of days in given period).|Baseline (Screening) and until Follow-up or early discontinuation (assessed up to 46 days)|All Subjects Population. Only participants with baseline and post-baseline seizure measurements were included in the analysis.|||Percent change||Standard Deviation|Mean
2669545|NCT01494584|Secondary|Number of Participants With the Indicated Urinalysis Parameter Dipstick Test Results From Screening to Follow-up|Urinalysis parameters analyzed included: urine occult blood (UOB), urine glucose (UG), urine ketones (UK), and urine protein (UP). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test provides results in a semi-quantitative manner, and results can be read as negative (Neg), Trace, and 80, indicating proportional concentrations in the urine sample. Urinalysis parameters were assessed at Titration 1 (T1; 300 mg/day), Titration 2 (T2; 450 mg/day), Titration 3 (T3; 600 mg/day), Titration 4 (T4; 750 mg/day), and Titration 5 (T5; 900 mg/day).|Screening, Day 1 (D1), Day 7 (D7), Day 14 (D14), Day 21 (D21), Day 28 (D28), Day 35 (D35), and at the Follow-up Visit (up to Day 46)|All Subjects Population (ASP). Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X, X in the category titles). Different participants may have been analyzed at different time points and for different parameters, so the overall number of participants analyzed reflects everyone in the ASP.|||Participants|||Number
2669546|NCT01494584|Secondary|Change From Baseline in Red Blood Cell Count at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time point were analyzed.|||10^12 cells/L (TI/L)||Standard Deviation|Mean
2669547|NCT01494584|Secondary|Change From Baseline in Mean Corpuscle Volume at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time point were analyzed.|||Femtoliters (FL)||Standard Deviation|Mean
2669548|NCT01494584|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time point were analyzed.|||Picograms (PG) per cell (PG/cell)||Standard Deviation|Mean
2669549|NCT01494584|Secondary|Change From Baseline in Hematocrit at Day 7 Post Each Up-titration|"Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit. The International System of Units (SI) Fraction of one unit (1) is reported here."|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time point were analyzed.|||Fraction of one unit (1)||Standard Deviation|Mean
2669550|NCT01494584|Secondary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter (G/L)||Standard Deviation|Mean
2669551|NCT01494584|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total ANC [Total Absolute Neutrophil Count]), Platelet Count, and White Blood Cell Count at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Giga (10^9) cells per liter (GI/L)||Standard Deviation|Mean
2669552|NCT01494584|Secondary|Change From Baseline in Calcium, Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (BUN) at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimoles per liter (MMOL/L)||Standard Deviation|Mean
2669553|NCT01494584|Secondary|Change From Baseline in Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Micromoles per liter (UMOL/L)||Standard Deviation|Mean
2669554|NCT01494584|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, and Gamma Glutamyl Transferase at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||International Units per Liter (IU/L)||Standard Deviation|Mean
2669555|NCT01494584|Secondary|Change From Baseline in Albumin and Total Protein at Day 7 Post Each Up-titration|Change from baseline was calculated 7 days after each up-titration (Day 7 for 300 mg/day dose; Day 21 for up-titration to 600 mg/day dose; Day 35 for up-titration to 900 mg/day dose) by subtracting the baseline value from the individual post-dose values. Baseline is defined as the Screening visit.|Baseline (Screening), Day 7, Day 21, and Day 35|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per Liter (G/L)||Standard Deviation|Mean
2669556|NCT01494584|Secondary|Number of Participants With Any Adverse Event (AE)|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.|From the start of the first titration until follow-up (assessed up to 46 days)|All Subjects Population: all participants who received at least one dose of study medication|||Participants|||Number
2669557|NCT01494584|Primary|Apparent Volume of Distribution (Vd/F) Following Oral Administration of Ezogabine/Retigabine|The volume of distribution (Vd/F) is defined as MRT*CL/F, where MRT is the mean residence time (calculated as AUMC[0-tau]/AUC[0-tau], where AUMC[0-tau] is the area under the first moment curve determined as the area under the concentration*time versus time curve). Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate the apparent volume of distribution.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|Pharmacokinetic Population. Only those participants available at the specified time points were analyzed.|||Liters||95% Confidence Interval|Geometric Mean
2669558|NCT01494584|Primary|Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) Following Oral Administration of Ezogabine/Retigabine|Cmax is defined as the first occurrence of the maximum observed plasma concentration. Ctau refers to the pre-dose (trough) concentration after the dosing interval which is equal to the minimum observed concentration (Cmin) at Steady State. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate Cmax and Ctau.|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|Pharmacokinetic Population|||Nanograms/Milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
2669560|NCT01494584|Primary|The Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) Following Oral Administration of Ezogabine/Retigabine|The steady state pharmacokinetic profile following oral administration of ezogabine/retigabine included determining the area under the curve over the dosing interval (AUC[0-tau]). The area under the plasma concentration-time curve over the dosing interval (AUC[0-tau]) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. Blood samples were collected at pre-dose and at 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35 to estimate AUC(0-tau).|Pre-dose and 0.5, 1, 1.5, 2, 4, 6, and 8 hours post-dose on Day 7, Day 21, and Day 35|Pharmacokinetic Population: all participants in the All Subjects Population (defined as all participants who received at least one dose of study medication) for whom a pharmacokinetic sample was obtained and analyzed|||Hour*Nanograms/Milliliter (h.ng/mL)||95% Confidence Interval|Geometric Mean
2669561|NCT01494545|Primary|Likert Statement: I am Interested in Purchasing These Contact Lenses.|The participant indicated purchase intent using a 4-point scale: 2=Very Interested; 1=Interested; -1=Not Interested; -2=Very Disinterested. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
2669562|NCT01494545|Primary|Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is:|The participant indicated overall satisfaction/dissatisfaction with the contact lenses using a 5-point scale: 2=Much Better; 1=A Little Better; 0=Same; -1=A Little Worse; -2=Much Worse. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
2669563|NCT01494545|Secondary|Investigator's Rating of Ease of Fit|"The investigator indicated agreement/disagreement with the statement, The study lenses were easy to fit for this subject, by using a 4-point scale: 1=Strongly Agree; 2=Agree; 3=Disagree; 4=Strongly Disagree."|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
2669564|NCT01494545|Secondary|Investigator's Overall Impression of Surface Wettability by Visit|The investigator rated his/her overall impression of the surface wettability of the contact lens on a 10-point scale (1=poor to 10=excellent).|Day 1, Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
2669565|NCT01494545|Secondary|Investigator's Satisfaction With Lens Fit by Visit|The investigator considered the factors that relate to a well-fitted contact lens, including good centration, adequate movement, and complete corneal coverage, and rated his/her satisfaction with the contact lens fit on 10-point scale, with 1 being not at all satisfied and 10 being very satisfied.|Day 1, Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
2669566|NCT01494545|Secondary|Duration of Overall Training Time|The investigator recorded the time it took for the patient to insert both lenses and remove both lenses, not including instructions.|Day 1|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Minutes||Standard Deviation|Mean
2669567|NCT01494545|Secondary|Lens Surface Characteristics: Dry Areas/Non-Wetting|The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of eyes|Participants||Number
2669568|NCT01494545|Secondary|Lens Surface Characteristics: Dry Areas/Non-Wetting|The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).|Day 7|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of eyes|Participants||Number
2669569|NCT01494545|Secondary|Lens Surface Characteristics: Dry Areas/Non-wetting|The investigator assessed the surface of the contact lens while the lens was on the participant's eye for dry areas/non-wetting: 0=None; 1=Very Slight; 2-Slight; 3=Moderate; 4=Severe. Assessments were made individually (by eye) and binocularly (both eyes together).|Day 1|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of eyes|Participants||Number
2669570|NCT01494545|Primary|Likert Statement: My Peripheral Vision is Better With These Contact Lenses Than With my Eye Glasses.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
2669571|NCT01494545|Primary|Likert Statement: At the End of the Day my Vision is Better With These Contacts Lenses Compared to my Eye Glasses.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=strongly agree; 1=agree; -1=disagree; -2=strongly disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
2669572|NCT01494545|Primary|Likert Statement: Overall, my Vision is Better With These Contact Lenses Compared to my Eye Glasses.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
2669573|NCT01494545|Primary|Likert Statement: I Liked These Contact Lenses so Much That I Will Recommend Them to my Friends.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 22=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
2669574|NCT01494545|Primary|Likert Statement: These Contact Lenses Are Perfect for When I Choose Not to Wear my Eye Glasses.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
2669575|NCT01494545|Primary|Likert Statement: These Contact Lenses Felt so Comfortable That I Forgot I Was Wearing Them.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
2669576|NCT01494545|Primary|Likert Statement: These Contact Lenses Were so Comfortable That I Barely Felt Anything.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
2669577|NCT01494545|Primary|Likert Statement: These Contact Lenses Were so Comfortable That I Don't Feel Anything.|The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.|Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Percentage of participants|||Number
2669578|NCT01494545|Primary|Average Comfortable Daily Wear Time by Visit|Average comfortable daily wear time was reported by the participant as a single, retrospective evaluation of the previous week of wear.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Hours||Standard Deviation|Median
2669579|NCT01494545|Primary|Overall Quality of Vision by Visit|Overall quality of vision was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
2669580|NCT01494545|Primary|Quality of Vision at End of Day by Visit|Quality of vision at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
2669581|NCT01494545|Primary|Quality of Vision During the Day by Visit|Quality of vision during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
2669582|NCT01494545|Primary|Quality of Vision at Insertion by Visit|Quality of vision at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
2669583|NCT01494545|Primary|Initial Quality of Vision|Initial quality of vision was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 1|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
2669584|NCT01494545|Primary|Overall Comfort by Visit|Overall comfort was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
2669585|NCT01494545|Primary|Comfort at End of Day by Visit|Comfort at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
2669586|NCT01494545|Primary|Comfort During the Day by Visit|Comfort during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
2669587|NCT01494545|Primary|Comfort at Insertion by Visit|Comfort at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 7, Day 14|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
2669588|NCT01494545|Primary|Initial Comfort|Initial comfort was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.|Day 1|This reporting group includes all enrolled and dispensed participants, minus major protocol deviations as determined by review.|||Units on a scale||Standard Deviation|Mean
2669589|NCT01494532|Secondary|Percentage of Participants Withdrawn From the Study Due to Lack of Efficacy|The percentage of participants who withdrew from the study due to lack of efficacy as defined by either the participant or the investigator is presented here. All participants with a non-missing efficacy observation at Baseline and at least one post-Baseline efficacy assessment at any time during the study were analyzed.|From start of study treatment until end of treatment (assessed up to 18 weeks)|ITT Population. Participants with a non-missing efficacy observation at Baseline and at least one post-Baseline efficacy assessment at any time during the study were analyzed.|||Percentage of participants|||Number
2669590|NCT01494532|Secondary|Change From Baseline in UPDRS Part I at Week 4 of the Maintenance Period|"The UPDRS Part I scores mentation, behavior and mood as determined by a physician and par. were tested during the on phase of PD. This component of the UPDRS is the total score for 4 items (the items 1 to 4 include intellectual impairment, thought disorder, motivation / initiative, and depression) and may have a value ranging from 0 to 16 as determined by a physician. The higher score (16) indicates the maximum score and the worse condition. All 4 items have to be present for a total score to be calculated. If one or more items are missing, the total score for the component would also be missing. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the individual post-randomization values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline (BL) and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Score on scale||95% Confidence Interval|Least Squares Mean
2669591|NCT01494532|Secondary|"Change From Baseline in UPDRS ADL Score With Participants in an Off State, at Week 4 of the Maintenance Period"|"The UPDRS Part II is the ADL score and can range from 0 to 52 as determined by the physician. The higher score indicates the worse condition. Test was performed when the par is in the off state of PD. The off time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Score on scale||95% Confidence Interval|Least Squares Mean
2669592|NCT01494532|Secondary|"Change From Baseline in UPDRS Activities of Daily Living (ADL) Score With Participants in an on State, at Week 4 of the Maintenance Period"|"The UPDRS Part II is the ADL score and can range from 0 to 52 as determined by the physician. The higher score indicates the worse condition. Test were performed when the par. is in the on state of PD. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Score on scale||95% Confidence Interval|Least Squares Mean
2669593|NCT01494532|Secondary|"Change From Baseline in Unified Parkinson Disease Rating Scale (UPDRS) Motor Score With Participants in an on State, at Week 4 of the Maintenance Period"|"The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the par.. One of the six features include the Part III-motor examination where scores can range 0 to 108 with par. in an on state where the maximum score indicates the worse condition. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Score on scale||95% Confidence Interval|Least Squares Mean
2669594|NCT01494532|Secondary|Change From Baseline in Total Sleep Time During the Night Time Hours of Sleep as a Percentage of a 24-hour Day, at Week 4 of the Maintenance Period|"Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total sleep hours during the night time hours of sleep was the average across the 2 diary cards of the sum of time (hours) asleep during night time in each 24-hour diary card. The percentage of a 24-hour day spent asleep during the night time hours = Total sleep hours during the night time hours of sleep divided by 24 × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Percentage of time in hours||95% Confidence Interval|Least Squares Mean
2669595|NCT01494532|Secondary|"Change From Baseline in the Percent of a 24-hour Day Spent on at Week 4 of the Maintenance Period"|"Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of day awake hours spent on per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on in each 24-hour diary card. The percentage of a 24-hour day spent on = Awake time spent on divided by 24 × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
2669627|NCT01494350|Secondary|Area of Index Lesions Throughout the Study|Area (mm^2) of index lesion on Days 0, 20, 28, 42, and 98.|Measured at day 0, 20, 28, 42, and 98|modified intent to treat (mITT). Baseline for this outcome measure does not include one subject (1 index lesion) who withdrew on Day 18.|||mm^2|Participants|Standard Deviation|Mean
2669596|NCT01494532|Secondary|"Change From Baseline in the Percent of a 24- Hour Day Spent on Without TD at Week 4 of the Maintenance Period"|"Dyskinesias are involuntary twisting, turning movements caused by medication during on time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hr diary cards for the 2 days preceding each visit. The total number of day awake hr spent on without TD per 24-hr period was the average across the 2 diary cards of the sum of awake hours spent on without TD in each 24-hour diary card. The percentage of 24 hr day spent on without TD= awake time spent on without TD divided by 24 × 100. BL is defined as the last non-missing assessment measured on or before the first dose date, change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
2669597|NCT01494532|Secondary|"Change From Baseline in the Percent of a 24-hour Day Spent Off at Week 4 of the Maintenance Period"|"The off state is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia), with or without additional features such as tremor or rigidity. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of day awake hours spent off per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent off in each 24-hour diary card. The percentage of 24 hour day spent off= awake time spent off divided by 24 x 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||"Percentage of off time in hours"||95% Confidence Interval|Least Squares Mean
2669598|NCT01494532|Secondary|"Change From Baseline in the Percent Awake Time Spent on at Week 4 of the Maintenance Period"|"Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent on per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on in each 24-hour diary card. The percentage of awake time spent on= Awake time spent on divided by (Awake time spent on + Awake time spent off) × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
2669599|NCT01494532|Secondary|"Change From Baseline in the Percent Awake Time Spent on Without TD at Week 4 of the Maintenance Period"|"Dyskinesias are involuntary twisting, turning movements caused by medication during on time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hr diary cards for the 2 days preceding each visit of the study. The total number of awake hr spent on without TD per 24-hr period was the average across the 2 diary cards of the sum of awake hr spent on without TD in each 24-hr diary card. Percentage of awake time spent onwithout TD= Awake time spent on without TD divided by(Awake time spent on + Awake time spent off) × 100. BL is defined as the last non-missing assessment measured on or before the first dose date, change from BL was calculated by subtracting BL values from MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
2669600|NCT01494532|Secondary|"Change From Baseline in the Percent Awake Time Spent Off at Week 4 of the Maintenance Period"|"The off state is defined as the state in which the participants' symptoms include lack of mobility(bradykinesia), with or without additional features such as tremor or rigidity. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent off per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent off in each 24-hour diary card. The percentage of awake time spent off= Awake time spent off divided by (Awake time spent off + Awake time spent on) × 100. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||"Percentage of off time in hours"||95% Confidence Interval|Least Squares Mean
2669601|NCT01494532|Secondary|Percent Change From Baseline in Total Sleep Time During the Night Time Hours of Sleep, at Week 4 of the Maintenance Period|"Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total sleep hours during the night time hours of sleep was the average across the 2 diary cards of the sum of time (hours) asleep during night time in each 24-hour diary card. BL is defined as the last non-missing assessment measured on or before the first dose date. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL value × 100. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Percentage of total sleep time in hours||95% Confidence Interval|Least Squares Mean
2669628|NCT01494350|Primary|Final Clinical Cure Rate for the Index Lesion|Number of index lesions with 100% reepithelialization at Day 98.|Final clincial cure is measured at day 98|modified intent to treat (mITT)|||lesions|Participants||Number
2669602|NCT01494532|Secondary|"Percent Change From Baseline in Awake Time Spent on at Week 4 of the Maintenance Period"|"Par. were asked to recordawake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent on per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on in each 24-hour diary card. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL values × 100. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
2669603|NCT01494532|Secondary|"Percent Change From Baseline in Awake Time Spent on Without TD at Week 4 of the Maintenance Period"|"Dyskinesias are involuntary twisting, turning movements caused by medication during on time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent on without TD per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on without TD in each 24-hour diary card. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL values × 100. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||"Percentage of on time in hours"||95% Confidence Interval|Least Squares Mean
2669604|NCT01494532|Secondary|"Percent Change From Baseline in Awake Time Spent Off at Week 4 of the Maintenance Period"|"The off state is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia), with or without additional features such as tremor or rigidity. Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent off per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent off in each 24-hour diary card. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL values multiplied (×) the results with 100. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||"Percentage of off time in hours"||95% Confidence Interval|Least Squares Mean
2669605|NCT01494532|Secondary|Change From Baseline for Total Sleep Time During the Night Time Hours of Sleep at Week 4 of the Maintenance Period|"Par. were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total sleep hours during the night time hours of sleep was the average across the 2 diary cards of the sum of time (hours) asleep during night time in each 24-hour diary card. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Hours||95% Confidence Interval|Least Squares Mean
2669606|NCT01494532|Secondary|"Change From Baseline in Absolute Awake Time Spent on at Week 4 of the Maintenance Period"|"Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent on per 24-hour period was the average across the 2 diary cards of the sum of the awake hours spent on in each 24 hour diary card. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Hours||95% Confidence Interval|Least Squares Mean
2669607|NCT01494532|Secondary|"Change From Baseline in Absolute Awake Time Spent on Without Troublesome Dyskinesia (TD) at Week 4 of the Maintenance Period"|"Dyskinesias are involuntary twisting, turning movements caused by medication during on time in Parkinson's Disease (PD). TD is defined as those movements that interfere with function and cause meaningful discomfort. Par were asked to record awake time off, awake time on, TD during awake time on, or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit. The total number of awake hours spent on without TD per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent on without TD in each 24 hour diary card. The change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from Mixed Model Repeated Measures (MMRM). Par with a non-missing efficacy observation at BL and during the MP were analyzed."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Hours||95% Confidence Interval|Least Squares Mean
2669608|NCT01494532|Secondary|Responder Rate According to the Clinical Global Impression-global Improvement (CGI-I) Scale at Week 4 of the Maintenance Period|"The CGI-I scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The scale is rated from 1-7 where 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The responder rate is defined as the percentage of participants with a score of 1 or 2. The Generalized Estimating Equations (GEE) model was used to determine CGI responder rate with treatment, visit, and treatment by visit interaction included in the model. Only scheduled visits were included."|Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Percentage of participants|||Number
2669609|NCT01494532|Secondary|"Percentage of Participants With a >=2 Hours Reduction in Baseline Off Time at Week 4 of the Maintenance Period"|"The off time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. Percentage of participants meeting the criterion (LS mean on inverse linked scale), odds ratio with 95% CI and p-value comparing against placebo were estimated by Generalized Estimating Equations (GEE) model. Baseline 'off-time', treatment, visit and treatment*visit are included in the model."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||percentage of participants||95% Confidence Interval|Least Squares Mean
2669610|NCT01494532|Secondary|"Percentage of Participants With a >=1 Hour Reduction in Baseline Off Time at Week 4 of the Maintenance Period"|"The off time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. Percentage of participants meeting the criterion (LS mean on inverse linked scale), odds ratio with 95% CI and p-value comparing against placebo were estimated by Generalized Estimating Equations (GEE) model. Baseline 'off-time', treatment, visit and treatment*visit are included in the model."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||percentage of participants||95% Confidence Interval|Least Squares Mean
2669611|NCT01494532|Secondary|"Responder Rate Defined as the Percentage of Participants With a 20% Reduction in Baseline (BL) Off Time at Week-4 of Maintenance Period"|"The responder rate was defined as the percentage of par with greater than or equal to (>=) 20 percent (%) reduction in their individual BL off time at Week 4 of the Maintenance Period. The off time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. Responder Rate (Least Squares [LS] means on inverse linked scale), odds ratio with 95% CI and p-value comparing against placebo were estimated by Generalized Estimating Equations (GEE) model. Baseline total awake time 'Off', treatment, visit and treatment*visit are included in the model."|Week 4 of the Maintenance Period (Study Week 17)|ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||percentage of participants||95% Confidence Interval|Least Squares Mean
2669612|NCT01494532|Primary|"Change From Baseline (BL) in Total Awake Time Spent Off at Week 4 of Maintenance Period"|"Off time is defined as the state in which the participants(par) symptoms include lack of mobility(bradykinesia) with or without additional features such as tremor or rigidity. Par were asked to record awake time off , awake time on, troublesome dyskinesias(TD) during awake time on, or time asleep for 30 minute intervals in 24 hr diary cards for 2 days preceding visits. Total number of awake hrs spent off per 24-hr period was the average of the 2 diary cards of the sum of awake hours spent off in each 24-hr diary card. BL is the last non-missing assessment measured on or before the first dose, change from BL was calculated by subtracting the BL values from the MP Week 4 values. Mixed Model Repeated Measures (MMRM) model used BL total awake time 'Off', treatment, visit and treatment by visit"|Baseline and Week 4 of the Maintenance Period (Study Week 17)|The Intent to Treat(ITT) Population included all randomized par who received at least one dose of study medication, had a BL efficacy assessment for the outcome, and at least one respective Post-BL efficacy assessment. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed.|||Hours||95% Confidence Interval|Least Squares Mean
2669613|NCT01494506|Secondary|Pharmacokinetic Measurements of Total Irinotecan|Plasma concentration-time data for MM-398 will be analyzed using population pharmacokinetic methods.|6 weeks after first study drug administration|PK population was based on Protocol, all participants who received the appropriate dose of MM-398.|||Total irinotecan = ug/L; SN38= ug/L||Geometric Coefficient of Variation|Geometric Mean
2669614|NCT01494506|Secondary|EORTC-QLQ-C30|This patient recorded outcome consists of 15 subscales in 3 independent domains: global health-related quality of life (HRQoL), functional scales (cognitive, emotional, physical, role and social functioning), and symptom scales (appetite loss, constipation, diarrhea, dyspnea, fatigue, insomnia, nausea and vomiting, and pain). For each subscale, patients were classified as improved, worsened or stable. Improvement is indicated by achievement of subscale score at least 10% improved from baseline and maintained for at least 6 weeks. Worsened is indicated by subscale score at least 10% worse than baseline. Stable is indicated by neither improvement nor worsened. Achievement of improvement prior to worsening was classified as improvement.|Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months|ITT patients who had baseline and at least one-post baseline EORTC-QLQ-C30 assessment.|||percent of patients in category|||Number
2669615|NCT01494506|Secondary|Percentage of Patients With Tumor Marker (CA 19-9) Response|Tumor marker response (TMR) was evaluated by the change in CA19-9 serum levels. Response was defined as a decrease of 50% of CA19-9 in relation to the baseline level at least once during the treatment period.|Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months|Patients with elevated baseline CA19-9 value (> 30 U/mL) who received study drug.|||percent of participants with TMR|||Number
2669629|NCT01494298|Secondary|Lipoprotein a [Lp(a)] in African Americans With Diabetes and Without.||at study entry||||mg/dL||Standard Error|Least Squares Mean
2669630|NCT01494298|Secondary|LDL Density in African American Males With Diabetes and Those Without Diabetes|"LDL size subclassification was divided into the following groups (from largest size to smallest size): LDL I, LDL IIa, LDL IIb, LDL IIIa, LDL IIIb, LDL IVa, LDL IVa, and LDL IVb.~For differences posted P<0.05 for LDL I, LDL IIb, LDL IIIa, and LDL IIIa +b"|at entry||||percentage of total LDL particles||Standard Error|Least Squares Mean
2669631|NCT01494298|Primary|ApoB Levels in African American Men With Diabetes and Those Without.|Apolipoprotein B Age adjusted least square means are reported because of baseline differences in ages.|At study entry||||mg/dL||Standard Error|Least Squares Mean
2669616|NCT01494506|Secondary|Percentage of Patients With Clinical Benefit Response|"Composite measure based on patient-reported pain (per VAS), patient-reported pain medication, KPS, and weight. Clinical benefit is indicated by either:~(a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity) with stable or improved KPS; or (b) improvement in KPS with stable or improved pain.~With stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change.~Clinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week period."|Randomization to treatment discontinuation.The maximum time in follow up was 25 months|"Clinical Benefit Response Evaluable Population: Patients who received study drug and met at least one of the following criteria were defined as eligible for evaluation of CBR:~baseline pain intensity ≥ 20 (out of 100)~baseline morphine consumption ≥ 10 mg/day PO morphine equivalents~baseline KPS of 70 to 90 points"|||percentage of participants with CBR|||Number
2669617|NCT01494506|Secondary|Time to Treatment Failure|Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death.|Randomization to treatment discontinuation (any cause). The maximum time in follow up was 25 months|ITT Population|||months||95% Confidence Interval|Median
2669618|NCT01494506|Secondary|Objective Response Rate|The objective response rate was a secondary efficacy endpoint of the study and was defined by the percentage of patients in the study population with a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by the investigator. Best overall response was defined per RECIST (version 1.1) recorded from randomization until progression or end of study. RECIST (v 1.1) criteria does not require confirmation of response, but an additional, more stringent analysis was also conducted, with designation of CR (or PR) requiring confirmation of response at least 4 weeks following the initial assessment of CR (or PR). Stable disease (SD) required an assessment of SD at least 6 weeks after starting treatment. Subjects with insufficient data for response classification were classified as Not Evaluable for best overall response, and as a non-responder for objective response, in the ITT population. Treatment groups are as indicated for the primary outcome of OS.|Assessment every 6 weeks after initial response; Day 1 to data cut off of 14 Feb 2014; maximum time on study 25 months.|ITT Population|||percentage with confirmed response||95% Confidence Interval|Number
2669619|NCT01494506|Secondary|Progression Free Survival|"Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods.~The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol."|Randomization until disease progression or death from any cause; Until the data cut off of 14 Feb 2014. The maximum time in follow up was 25 months.|ITT Population|||months||95% Confidence Interval|Median
2669620|NCT01494506|Primary|Overall Survival|"Overall survival was the primary efficacy endpoint of the study and was defined as the time from the date of patient randomization to the date of death or the date the patient was last known to be alive. OS was summarized by Kaplan-Meier methodology for each treatment group. Pairwise treatment group comparisons were carried out using unstratified log rank analyses on the ITT population. Hazard ratio estimates are from Cox regression analysis.~The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol."|From randomization to death; until the data cut off 14 Feb 2014. The maximum time in follow up was 25 months.|Intent to Treat population (ITT population) consisted of all randomized participants. Efficacy analyses in the ITT population consider treatment group according to randomization. Comparisons of the MM-398+5-FU/LV to 5-FU/LV were carried out only on patients who were randomized under protocol version 2 or later.|||months||95% Confidence Interval|Median
2669621|NCT01494467|Secondary|Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)|Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).|Baseline to Week 12||||Percentage of change in lesion counts||Standard Deviation|Mean
2669622|NCT01494467|Primary|Absolute Change in Inflammatory Lesion Count|Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).|Baseline to Week 12|LOCF, ITT|||Lesion count change||Standard Deviation|Mean
2669623|NCT01494467|Primary|Success Rate|"Percentage of subjects who achieve Clear (Score 0) or Almost Clear (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score.~Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale:~Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)"|Week 12|LOCF, ITT|||Percentage of participants|||Number
2669624|NCT01494350|Secondary|Number of All Ulcerated Lesions With Reepithelialization on Day 28|Final cure rate for all ulcerated lesions (100% reepithelialization for ulcerative lesions) on Day 28|Measured on day 28|modified intent to treat (mITT). This outcome measure does not include one subject (2 lesions) who withdrew on Day 18.|||lesions|Participants||Number
2669625|NCT01494350|Secondary|Area of All Ulcerated Lesions Throughout the Study|Area of all ulcerated lesions on Days 20, 28, 42, and 98.|Measured at day 20, 28, 42 and 98|modified intent to treat (mITT). Baseline for this outcome measure does not include one subject (2 lesions) who withdrew on Day 18.|||mm^2|Participants|Standard Deviation|Mean
2669633|NCT01494051|Primary|Energy Expenditure|does energy expenditure and substrate oxidation differ between subjects randomized to the high carbohydrate versus the high protein diet? We measured resting energy expenditure with indirect calorimetry and estimated substrate oxidation with indirect calorimetry results and urine urea nitrogen excretion. We also measured total energy expenditure with doubly labeled water.|change from baseline after 4 months of treatment||||kcal||Standard Deviation|Mean
2669634|NCT01494038|Secondary|Number of Women by Level of Adherence to Prescribed Regimen, as Assessed by Pill Count|Adherence is the percentage of expected doses taken during the 28 week active treatment period. Pill count: participants returned their prescription pill containers, and the remaining (unused) pills were counted.|Adherence reported every 4 weeks during active treatment; study entry through week 28 for Arm A, week 12 postpartum through week 40 postpartum for Arm B|All enrolled women|||Participants|||Count of Participants
2669635|NCT01494038|Secondary|Number of Women by Level of Adherence to Prescribed Regimen, as Assessed by Self-report|Adherence is the percentage of expected doses taken during the 28 week active treatment period, categorized as poor (<60%), reasonable (>= 60%, <80%), good (>=80%, <90%), or excellent (>= 90%). Measured by participant's self-report of doses taken within the last 3 days.|Adherence reported every 4 weeks during active treatment; study entry through week 28 for Arm A, week 12 postpartum through week 40 postpartum for Arm B|All women enrolled.|||Participants|||Count of Participants
2669636|NCT01494038|Secondary|Agreement Between IGRA and TST TB Tests, Women at 44 Weeks Postpartum|IGRA done by Quantiferon Gold Test (QGIT). For women, TST is considered positive if greater than or equal to 5 mm|Measured at Week 44 postpartum|Women who were tested for tuberculosis infection at 44 weeks postpartum|||Participants|||Count of Participants
2669637|NCT01494038|Secondary|Agreement Between IGRA and TST TB Test Results, Infant|The TST result was positive if greater than or equal to 10 mm in HIV-negative infants, or greater than or equal to 5 mm in HIV-positive infants.|Measured at week 44 after birth|Infants with tuberculin tests performed at week 44 postpartum|||Participants|||Count of Participants
2669638|NCT01494038|Secondary|Agreement Between Interferon-gamma Release Assay (IGRA) TB Test and Tuberculin Skin Test (TST) Results, Women at Delivery|IGRA done by Quantiferon Gold Test (QGIT). For women, TST is considered positive if greater than or equal to 5 mm|Measured at delivery|Women tested for tuberculosis infection at delivery|||Participants|||Count of Participants
2669639|NCT01494038|Secondary|Pharmacokinetic (PK) Parameter: Adjusted Mean of Area Under the Curve (AUC24h), for EFV|Pharmacokinetic parameter was estimated from population PK modeling fitted to the intensive PK data. AUC0-24h was predicted using population pharmacokinetic model using the NONMEM software program. A 2-compartment model with first-order absorption with transit compartment and first-order elimination with well-stirred liver model to capture hepatic clearance and first-pass extraction with 1 parameter (hepatic intrinsic clearance) was used,|Measured at antepartum (third trimester and >= 2 weeks after starting study drug) and week 16 postpartum (+/-) 4 weeks) while on active INH; blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dosing.|Participants with intensive pharmacokinetic results while on active EFV and who were stabled on EFV-based ART.|||hour*mg/L||95% Confidence Interval|Mean
2669640|NCT01494038|Secondary|Pharmacokinetic (PK) Parameter: Adjusted Mean of Area Under the Curve of Plasma Concentration Versus Time (AUC24h), for INH|Pharmacokinetic parameter was estimated from population PK modeling fitted to the intensive PK data. AUC0-24h was predicted using population pharmacokinetic model using the NONMEM software program. A 2-compartment model with first-order absorption with transit compartment and first-order elimination with well-stirred liver model to capture hepatic clearance and first-pass extraction with 1 parameter (hepatic intrinsic clearance) was used,|Measured at antepartum (third trimester and >= 2 weeks after starting study drug) and week 16 postpartum (+/-) 4 weeks) while on active INH; blood samples were drawn pre-dose and at 1, 2, 4, 6, 8, and 12 hours post-dosing.|Participants with intensive pharmacokinetic results while on active INH, who were established on INH.|||hour*mg/L||95% Confidence Interval|Mean
2669641|NCT01494038|Secondary|Number of Infants With Tuberculosis Resistant to INH|Resistance to INH from isolates of Mycobacterium tuberculosis, as a percentage of infants who develop culture-confirmed TB|Measured from study entry through Week 48 after birth|No infants had culture-confirmed TB||||||
2669642|NCT01494038|Secondary|Number of Mothers With Tuberculosis Resistant to INH|Resistance to INH from isolates of Mycobacterium tuberculosis, as a percentage of mothers who develop culture-confirmed TB|Measured from study entry through Week 48 postpartum|Mothers with culture-confirmed TB|||Participants|||Count of Participants
2669643|NCT01494038|Secondary|Incidence Rate, up to 12 Weeks Postpartum, of Hepatotoxicity, Defined by DAIDS, Any Cause|Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata.|Measured from study start through 12 weeks postpartum|All women.|||events per 100 person-years|||Number
2669644|NCT01494038|Secondary|Incidence Rate, Antepartum, of Hepatotoxicity, Defined by DAIDS, Any Cause|Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata.|Measured from study entry through delivery|All women|||events per 100 person-years|||Number
2669645|NCT01494038|Secondary|Incidence Rate, up to 12 Weeks Postpartum, of Hepatotoxicity, Defined by DAIDS, Related to Treatment|Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata|Measured from study start through 12 weeks postpartum|All women|||events per 100 person-years|||Number
2669646|NCT01494038|Secondary|Incidence Rate, Antepartum, of Hepatotoxicity, Defined by DAIDS, Related to Treatment|Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata. Hepatotoxicity definition as defined by DAIDS AE grading criteria 1.0.|Measured from study entry through delivery|All women.|||events per 100 person-years|||Number
2669647|NCT01494038|Secondary|Incidence Rate, to 12 Weeks Postpartum, of Hepatotoxicity, Protocol-specific Definition, Any Cause|Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata.|Measured from study entry through 12 weeks postpartum|All women enrolled|||events per 100 person-years|||Number
2669648|NCT01494038|Secondary|Incidence Rate, Antepartum, of Hepatotoxicity, Protocol-specific Definition, Any Cause|Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata.|Measured from study entry through delivery|All women enrolled.|||events per 100 person-years|||Number
2669649|NCT01494038|Secondary|Incidence Rate, to 12 Weeks Postpartum, of Hepatotoxicity, Protocol-specific Definition, Related to Treatment|Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata|Measured from study entry through 12 weeks postpartum|All women enrolled.|||events per 100 person-years|||Number
2669650|NCT01494038|Secondary|Incidence Rate, Antepartum, of Hepatotoxicity, Defined by Protocol-specific Definition of Hepatotoxicity, Related to Treatment|Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata. Protocol-specific definition of hepatotoxicity: Any one of the following: 1) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5 times the upper limit of normal (ULN), where ULN is specified by the clinic physician; 2) Total bilirubin > 3 X ULN; 3) ALT greater than 3 X ULN and total bilirubin greater than 2 X ULN; or 4) ALT > 3 X ULN and persistent symptomatic clinical hepatitis|Measured from study entry through delivery|All women enrolled.|||events per 100 person-years|||Number
2669651|NCT01494038|Secondary|Incidence Rate, up to 12 Weeks Postpartum, of Grade 3 or Higher AE|Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata.|Measured from study entry through 12 weeks postpartum|All women enrolled.|||events per 100 person-years|||Number
2669652|NCT01494038|Secondary|Incidence Rate, Antepartum, of Grade 3 or Higher AE|Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata.|Measured from study entry through end of pregnancy|All women enrolled.|||events per 100 person-years|||Number
2669653|NCT01494038|Secondary|Incidence Rate of Combined Endpoint, up to 12 Weeks Postpartum: Grade 3 or Higher AE Related to Treatment, or Discontinuation of Treatment Due to AE|Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata.|Measured from study entry through 12 weeks after birth|All women enrolled.|||events per 100 person-years|||Number
2669654|NCT01494038|Secondary|Incidence Rate of Combined Endpoint, Antepartum: Grade 3 or Higher AE Related to Treatment, or Discontinuation of Treatment Due to AE|Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata|Measured from study entry through end of pregnancy|All women enrolled.|||events per 100 person-years|||Number
2669655|NCT01494038|Secondary|Incidence Rate of Combined Endpoints: Maternal TB, Maternal Death, Infant TB, or Infant Death|Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata.|Measured from study entry through Week 48 after birth|Number of mother-infant pairs with at least one infant live birth and in which mother did not have active TB at entry.|||events per 100 person-years|||Number
2669656|NCT01494038|Secondary|Incidence Rate of Combined Endpoints: Infant TB or Infant Death|Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata.|Measured from study entry through Week 48 after birth|Live-born infants of enrolled women|||events per 100 person-years|||Number
2669657|NCT01494038|Secondary|Incidence Rate of Combined Endpoints: Maternal TB or Maternal Death|Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata.|Measured from study entry through Week 48 after birth|All participants enrolled without active TB at entry.|||events per 100 person-years|||Number
2669658|NCT01494038|Secondary|Incidence Rate of Maternal Deaths|Incidence rate calculated by Mantel-Haenszel, weighted by gestational age strata.|Measured from study entry through Week 48 postpartum|All participants enrolled without active TB at entry|||events per 100 person-years|||Number
2669659|NCT01494038|Secondary|Incidence Rate of Infant Death|Incidence rate was calculated by Mantel-Haenszel, weighted by gestational age strata.|Measured from study entry through Week 48 after birth|Live-born infants of enrolled women|||events per 100 person-years|||Number
2669660|NCT01494038|Secondary|Incidence Rate of Tuberculosis (TB) Among Infants|Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata. Probable or confirmed TB, or congenital TB as defined using the Cantwell criteria (see reference), judged by the Secondary Endpoint Review Committee. Includes an infant death due to unknown cause.|Measured from study entry through Week 48 after birth|Live-born infants of enrolled women|||events per 100 person-years|||Number
2669661|NCT01494038|Secondary|Incidence Rate of TB Infection Among Mothers|Incidence rates calculated by Mantel-Haenszel, weighted by gestational age strata. Probable or confirmed TB infection, as judged by Secondary Endpoint Review Committee|Measured from study entry to Week 48 after birth|All participants enrolled without active TB at entry|||events per 100 person-years|||Number
2669662|NCT01494038|Secondary|Number of Infants Hospitalized|Hospitalization due to reasons other than birth|Measured from study entry through Week 48 after birth|Infants born alive|||Participants|||Count of Participants
2669663|NCT01494038|Secondary|Number of Infants Which Are HIV-infected|HIV infection determined during follow-up period. Infection at birth or during breastfeeding|Measured from study entry through study Week 44|Infants born alive|||Participants|||Count of Participants
2669664|NCT01494038|Secondary|Number of Infants With Grade 3 or Higher Clinical or Laboratory AE Related to Treatment|As before, but AE is judged to be possibly, probably, or definitely related to INH or Placebo for INH, by clinic medical staff|Measured from study entry through Week 48 after birth|Infants born alive|||Participants|||Count of Participants
2669665|NCT01494038|Secondary|Number of Infants With Grade 3 or Higher Clinical or Laboratory AE|Laboratory, sign/symptom, or diagnoses graded as 3 or higher by DAIDS criteria.|Measured from study entry through Week 48 after birth|Infants born alive|||Participants|||Count of Participants
2669666|NCT01494038|Secondary|Number of Mothers With an Adverse Pregnancy Outcome: Spontaneous Abortion, Stillbirth, Premature Birth, Low Birth Weight, or Congenital Anomaly|In case of a multiple birth, mothers who had at least one adverse pregnancy outcome. Spontaneous abortion is intra-uterine fetal death prior to 20 weeks of gestational age; stillbirth, the same, >= 20 weeks; preterm delivery, < 37 weeks of gestational age; low birth weight, < 2,500 grams, and congenital anomalies meeting the Metropolitan Atlanta Congenital Defects Program criteria.|Measured from study entry through Week 48 after birth|Mothers who had at least one live birth, stillbirth, or spontaneous abortion; participant with induced abortion is omitted, and whose babies were available for examination after birth (if born alive)|||Participants|||Count of Participants
2669667|NCT01494038|Secondary|Number of Mothers With an Infant With a Congenital Anomaly|Includes congenital anomalies meeting the Metropolitan Atlanta Congenital Defects Program criteria.|Measured from study entry through Week 48 after birth|Mothers who had at least one live birth able to be assessed between birth and 48 weeks after birth|||Participants|||Count of Participants
2669668|NCT01494038|Secondary|Number of Mothers With a Low Birth-weight Infant|Low birth weight is defined as weight < 2500 mg|Measured on day of birth|Mothers who had at least one live birth available to be weighed at time of delivery|||Participants|||Count of Participants
2669669|NCT01494038|Secondary|Number of Mothers With an Infant Born Prematurely|Premature birth is defined as gestational age of < 37 weeks at delivery.|Measured at delivery|Mothers who had at least one live birth|||Participants|||Count of Participants
2669671|NCT01494038|Secondary|Number of Mothers With a Fetal Death|Fetal deaths include both stillbirths and spontaneous abortions; in case of a multiple birth, mothers who had at least one fetal death|Measured from study entry through end of pregnancy|Mothers who had at least one live birth, stillbirth, or spontaneous abortion. One participant with outcome of induced abortion not included|||Participants|||Count of Participants
2669672|NCT01494038|Primary|Incidence Rate of Combined Endpoint: Grade 3 or Higher Adverse Events (AEs) Related to Treatment, or AE Causing Discontinuation of Treatment|Incidence rate, calculated by Mantel-Haenszel (MH), weighted by gestational age strata 1) gestational age at entry less than 24 weeks or 2) gestational age at entry greater than or equal to 24 weeks. AE's include laboratory results, signs/symptoms, or diagnoses; graded as per Division of AIDS (DAIDS) or by protocol-defined hepatotoxicity measures. Related to treatment indicates possibly, probably, or definitely related to INH or Placebo for INH as judged by Independent Endpoint Review Committee. Discontinuation refers to permanent discontinuation of study treatment.|Measured from study entry through Week 48 after birth|All women enrolled.|||events per 100 person-years|||Number
2669673|NCT01493960|Secondary|The Induction of Registration Remission|Percentage of participants with induction of registration remission, defined as a CAI score of ≤4 and an endoscopic score of 0 or 1, at week 4 and 12.|Week 4 and 12|FAS|||Percentage of Subjects||95% Confidence Interval|Number
2669674|NCT01493960|Secondary|The Induction of Symptomatic Remission|Percentage of participants with induction of symptomatic remission, defined as subscores of blood in stool and number of stools weekly not exceeding 0 and 0 or 1, respectively, at week 4 and 12.|Week 4, 12|FAS|||Percentage of Subjects||95% Confidence Interval|Number
2669675|NCT01493960|Secondary|The Induction of Mucosal Healing|Percentage of participants with induction of mucosal healing, defined as an endoscopic score of 0 or 1, at week 4 and 12.|Week 4 and 12|FAS|||Percentage of Subjects||95% Confidence Interval|Number
2669676|NCT01493960|Secondary|Steroid Free Remission at 12 Months|Percentage of participants with steroid free remission at 12 months after 1st dose.|at 12 months|FAS|||Percentage of Subjects||95% Confidence Interval|Number
2669677|NCT01493960|Secondary|The Rate of Colectomy|Percentage of participants undergoing colectomy at 12 months after 1st dose.|at 12 months|FAS|||Percentage of Subjects||95% Confidence Interval|Number
2669678|NCT01493960|Secondary|The Time to Colectomy|Median time to colectomy after 1st dose.|Within 12 months|FAS|||Time||95% Confidence Interval|Median
2669679|NCT01493960|Primary|Induction of Clinical Remission|The induction of clinical remission at week 12, defined as a CAI score of ≤4.(Full Analysis Set)|Week 12|The FAS consited of all randomized patients who met the inclusion criteria (as assessed by the investigator on the inclusion/exclusion criteria form), and received at least 1 dose of study drug (active or placebo), and who had at least 1 post randomization eligible value of the primary efficacy endpoint|||Percentage of participants||95% Confidence Interval|Number
2669680|NCT01493947|Other Pre-specified|Time to Relapse|Relapse define as time elapsed between Week 16 and first reoccurrence of Investigator Global assessement (IGA) at '2 (mild)' , '3 (moderate)' or '4 (severe)'.|Week 16 up to Week 52||||Median days to relapse||95% Confidence Interval|Median
2669681|NCT01493947|Primary|Percent Change in Inflammatory Lesions From Baseline to Week 16|Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period|Baseline and Week 16||||percentage of change||Standard Deviation|Mean
2669682|NCT01493778|Secondary|Health Resource Utilization and Caregiver Burden Associated With Bleeds (Per Year Per Patient)|Resource utilisation and caregiver burden are analysed in terms of average number of days of absence from work and use of mobility aids (e.g. wheelchair or crutches) as a consequence of bleeds. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.|From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial|The full analysis set included all dosed participants with data after dosing. Number of participants analysed=number of participants with data available.|||days/year/patient||Standard Deviation|Mean
2669683|NCT01493778|Secondary|Health Resource Utilization and Caregiver Burden Associated With Bleeds (Per Month Per Patient)|Resource utilisation and caregiver burden are analysed in terms of average number of days absent from work and use of mobility aids (e.g. wheelchair or crutches) as a consequence of bleeds. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.|From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial|The full analysis set included all dosed participants with data after dosing. Number of participants analysed=number of participants with data available|||days/month/patient||Standard Deviation|Mean
2669684|NCT01493778|Secondary|Change in Total Scores for Parent Reported Treatment Satisfaction|"The caregivers/parent reported treatment satisfaction is assessed by the parents using the haemophilia satisfaction questionnaire (HEMO-SAT). The questionnaire contained questions related to treatment that covered 6 domains (ease and convenience, efficacy, burden, specialist, centre and general satisfaction). Adults completing the questionnaire could achieve a score from 0 to 100, with lower scores reflecting greater treatment satisfaction. The scale range for each of the 6 domains was 0-100 with lower scores reflecting greater treatment satisfaction.~The scores of the domains at visit 3 (10th-15th ED), visit 5 (50th-55th ED) and end of trial (EoT) are presented."|Visit 3 (10th-15th ED); Visit 5 (50th-55th ED); End of trial (within 8 weeks of their last scheduled visit in the extension phase)|The full analysis set included all dosed participants with data after dosing. Number of participants analysed=number of participants who answered the questionnaire|||Score on a scale||Standard Deviation|Mean
2669732|NCT01493089|Primary|Determination of Median Time to Sustained Partial Response as Defined by Reduction in Likert Severity Scale Used to Assess Pain Associated With Heartburn in the Patient|Reduction in severity of heartburn by 2 points or more on a 9-point Likert severity scale, which is sustained for 45 minutes or more|up to 14 days following treatment|mITT|||Minutes||95% Confidence Interval|Median
2669685|NCT01493778|Secondary|Incidence Rate of High-titre Inhibitors Defined as Inhibitor Titre ≥ 5 BU (Bethesda Units)/mL)|Incidence rate (number of patients with new inhibitor in the period/number of participants at risk, expressed in percentage) of high-titre inhibitors defined as inhibitor titre ≥ 5 BU (Bethesda Units)/mL). The inhibitors were evaluated for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation) and the combined main and extension phase (from Visit 2 to end of trial).|From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial|The full analysis set included all dosed participants with data after dosing. The arm group - ‘main phase’ includes subjects who were treated both on-demand and preventively in the main phase. 'On-Demand' and 'Preventive' were not described as separate arms/groups in the protocol. These were not analysed separately for this endpoint.|||Percentage of participants||95% Confidence Interval|Number
2669686|NCT01493778|Secondary|Incidence Rate of Clinically Relevant Inhibitors Defined as an Inhibitor Titre (≥ 0.6 BU/mL) Combined With a Decreased Recovery (<66% of Expected Level)|The incidence rates (number of patients with new inhibitor in the period/number of participants at risk, expressed in percentage) of clinically relevant inhibitors were defined as an inhibitor titre (≥ 0.6 BU) combined with a decreased recovery (<66% of expected level). Incidence rate of clinically relevant inhibitors according to the type of assay used is presented. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation) and the combined main and extension phase (from Visit 2 to end of trial).|From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial|The full analysis set included all dosed participants with data after dosing. The arm group - ‘main phase’ includes subjects who were treated both on-demand and preventively in the main phase. 'On-Demand' and 'Preventive' were not described as separate arms/groups in the protocol. These were not analysed separately for this endpoint.|||Percentage of participants||95% Confidence Interval|Number
2669687|NCT01493778|Secondary|Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) Reported During the Trial Period|Number of adverse events and serious adverse events per patient years of exposure. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial (exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.|From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial|The safety analysis set included all dosed participants with data after dosing. The arm group - ‘main phase’ includes subjects who were treated both on-demand and preventively in the main phase. 'On-Demand' and 'Preventive' were not described as separate arms/groups in the protocol. These were not analysed separately for this endpoint.|||events per patient years of exposure|||Number
2669688|NCT01493778|Secondary|Consumption of Turoctocog Alfa (N8) (IU/kg/Months) for Bleed Prevention|Mean consumption of turoctocog alfa (N8) used for preventive treatment per month per patient. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.|From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial|The full analysis set included all dosed participants with data after dosing. Participants in on-demand treatment did not receive treatment for bleed prevention and therefore are not included in the analysis.|||IU/kg/month/patient||Standard Deviation|Mean
2669689|NCT01493778|Secondary|Consumption of Turoctocog Alfa (N8) (IU/kg/Bleed) Per Bleed|Mean consumption of turoctocog alfa (N8) used for treatment of bleed from start to stop of bleed. The analysis was based on number of bleeds. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.|From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial|The full analysis set included all dosed participants with data after dosing.|||IU/kg/bleed|bleeds|Standard Deviation|Mean
2669690|NCT01493778|Secondary|Total Consumption of Turoctocog Alfa (N8) Per Patient (Prevention, Treatment of Bleeds and During Surgery) Per Year|Mean total consumption of turoctocog alfa (N8) used for treatment (includes all injections given: prevention, treatment of bleeds and during surgery) per patient per year. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.|From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial|Full Analysis Set included all dosed participants with data after dosing.|||IU/kg/year/patient||Standard Deviation|Mean
2669691|NCT01493778|Secondary|Total Consumption of Turoctocog Alfa (N8) Per Patient (Prevention, Treatment of Bleeds and During Surgery) Per Month|Mean total consumption of turoctocog alfa (N8) used for treatment (includes all injections given: prevention, treatment of bleeds and during surgery) per patient per month. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.|From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial|Full Analysis Set included all dosed participants with data after dosing.|||IU/kg/month/patient||Standard Deviation|Mean
2671147|NCT01479478|Secondary|Neonatal Bilirubin Level||Up to 14 days following delivery|Participants with available data were included in the analysis.|||mg/dL||Inter-Quartile Range|Median
2669692|NCT01493778|Secondary|Number of Turoctocog Alfa (N8) Injections Required Per Bleed|The number of injections of turoctocog alfa (N8) required per bleed was calculated as the number of injections of turoctocog alfa used in the time period from start of the bleed to stop of the bleed. The mean number of turoctocog alfa injections required to stop the bleed is presented. The analysis was based on the total number of bleeds. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.|From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial|Full Analysis Set included all dosed participants with data after dosing. Number of participants analysed=number of participants with bleeding episodes.|||injections/bleed|bleeds|Standard Deviation|Mean
2669693|NCT01493778|Secondary|Annualised Bleeding Rate (ABR)|Annualised bleeding rate defined as number of bleeds in total per patient per year following treatment were estimated by a Poisson model allowing for over-dispersion. The Poisson estimate is presented with a 95% confidence interval (CI). The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.|From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial|The full analysis (FAS) set included all dosed participants with data after dosing. Participants in FAS with only one exposure day were excluded from preventive treatment in main when calculating the Poisson estimates of ABR as the small amount of information introduces uncertainty to the estimated ABR.|||bleeds/patient/year|bleeding episodes|95% Confidence Interval|Mean
2669694|NCT01493778|Secondary|Haemostatic Effect of Turoctocog Alfa on Treatment of Bleeds Assessed on a Predefined Four Point Scale: Excellent, Good, Moderate and None|The haemostatic effect of turoctocog alfa was summarised by frequency tables containing count of all bleeds and assessed on a predefined four point scale: Excellent, Good, Moderate and None. The analysis was based on the total number of bleeds and their response to treatment. The analysis was performed for the main phase (from Visit 2 to Visit 5 [50-55 exposure day], extension phase (from Visit 6 to end of trial; exposure day 100, expected to occur between 6 and 48 months of trial participation), the combined main and extension phase (from Visit 2 to end of trial) and for the inhibitor cohort.|From Visit 2 to Visit 5 (50-55 exposure day); From Visit 6 to end of trial, extension phase of the trial; From Visit 2 to end of trial, the combined main and extension phases of the trial|The full analysis set included all dosed participants with data after dosing.|||bleeds|bleeds||Count of Units
2669695|NCT01493778|Primary|Incidence Rate of Factor VIII Inhibitors (Above or Equal to 0.6 BU (Bethesda Units)/mL) for the Main Phase of the Trial|The incidence rate (percentage of participants with inhibitors) of inhibitors defined as inhibitor titres ≥0.6 BU for main phase of the trial.|From Visit 2 (21 days after screening) to Visit 5 (50-55 exposure day)|Analysis was based on participants who completed the main phase of the trial.|||Percentage of participants||95% Confidence Interval|Number
2669696|NCT01493687|Secondary|Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)|Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).|Baseline to Week 12|LOCF, ITT|||Percentage of change in lesion counts||Standard Deviation|Mean
2669697|NCT01493687|Primary|Absolute Change in Inflammatory Lesion Count|Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).|Baseline to Week 12|LOCF, ITT|||Lesion count change||Standard Deviation|Mean
2669698|NCT01493687|Primary|Success Rate|"Percentage of subjects who achieve Clear (Score 0) or Almost Clear (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score.~Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale:~Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)"|Week 12|LOCF, ITT|||Percentage of participants|||Number
2669699|NCT01493557|Secondary|Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom|Time between symptom onset and first observed complete or partial effectiveness and between symptom onset and last observed symptom by management strategy.|Week 8|Full Analysis Set (FAS)|||days||Standard Deviation|Mean
2669700|NCT01493557|Secondary|Rates of Complete or Partial Effectiveness of GIS at Each Visit.|"The percentage of patients experiencing complete or partial effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy.~Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy."|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8|Full Analysis Set (FAS).|||percentage of participants|||Number
2669701|NCT01493557|Secondary|Rates of Partial Effectiveness of GIS at Each Visit.|"The percentage of patients experiencing partial effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy.~Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy."|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8|Full Analysis Set (FAS)|||percentage of participants|||Number
2669702|NCT01493557|Secondary|Rates of Complete Effectiveness of GIS at Each Visit.|"The percentage of patients experiencing complete effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy.~Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy."|Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8|Full analysis Set (FAS).|||percentage of participants|||Number
2669841|NCT01491893|Secondary|Median Overall Survival (OS)|Time in months from the administration of PVSRIPO to the date of death from any cause. For patients alive as of the last follow-up, OS is censored at the last follow-up date. Median OS is estimated using Kaplan-Meier methods.|6 years||2021-06-30|06/2021||||
2669703|NCT01493557|Secondary|Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies|"The percentage of patients experiencing combined of complete or partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal.~Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un−resolved secondary GIS."|Week 8|Full Analysis Set (FAS)|||percentage of participants|||Number
2669704|NCT01493557|Secondary|Rate of Partial Effectiveness of Combined GIS Management Strategies|"The percentage of patients experiencing partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.~Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un−resolved secondary GIS."|Week 8|Full Analysis Set (FAS)|||percentage of participants|||Number
2669705|NCT01493557|Secondary|Rate of Complete Effectiveness of Combined GIS Management Strategies|"The percentage of patients experiencing complete relief of combined gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal.~Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved."|Week 8|Full Analysis Set (FAS)|||percentage of participants|||Number
2669706|NCT01493557|Secondary|Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies|"The percentage of patients experiencing complete or partial effectiveness of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.~Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un−resolved secondary GIS."|Week 4|Full Analysis Set (FAS)|||percentage of participants|||Number
2669707|NCT01493557|Secondary|Rate of Partial Effectiveness of Initial GIS Management Strategies|"The percentage of patients experiencing partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) and patients taking Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.~Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un−resolved secondary GIS."|Week 4|Full Analysis Set (FAS)|||percentage of participants|||Number
2669708|NCT01493557|Primary|The Rate of Complete Effectiveness of Initial GIS Management Strategy|"The percentage of patients experiencing complete relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks.~Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved."|Week 4|Full Analysis Set (FAS): This patient set included all patients who developed GIS and who were randomized into the two management strategies.|||percentage of participants|||Number
2669709|NCT01493531|Secondary|Subjects With ≥ 1 Target Tophus at Baseline Who Experience Complete Resolution of at Least 1 Target Tophus by Month 12|Proportion of subjects with ≥ 1 target tophus at Baseline who experience complete resolution of at least 1 target tophus by Month 12|12 months||||Proportion of Subjects|||Number
2669710|NCT01493531|Secondary|Gout Flares|Mean rate of gout flares requiring treatment for the 6-month period from the end of Month 6 to the end of Month 12.|12 Months||||Gout Flares||Standard Deviation|Mean
2669711|NCT01493531|Primary|Subjects With a Serum Urate (sUA) < 6.0 mg/dL by Month 6.|Proportion of subjects with an sUA level that is < 6.0 mg/dL by Month 6.|6 months|Intent-to-Treat Population|||Proportion of Subjects|||Number
2669712|NCT01493427|Secondary|Percentage of Patients With Target IOP (≤18 mmHg) at 12 Weeks|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Week 12|The Full Analysis Set (FA) included all subjects who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit.|||Percentage of participants|||Number
2669713|NCT01493427|Primary|Mean Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)|IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Baseline, Week 12|"The Full Analysis Set (FA) included all subjects who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit (N=187). Here, n is the number of participants with non-missing values at the specific time point."|||millimeters mercury (mmHg)||Standard Deviation|Mean
2669714|NCT01493414|Secondary|Medical Resource Utilization up to 5 Years|Percentage of patients requiring medical resources (blood transfusions, hospitalization, emergency room visits, general practitioners or specialists consultations, urgent care or splenic irradiation) up to 5 years.|Baseline up to approximately 5 years.|Full analysis set includes all patients who received at least one administration of study drug.|||Participants|||Count of Participants
2669725|NCT01493180|Primary|Change in the Keratoconjunctival Staining Score From Baseline|"Keratoconjunctival staining indicates the damage to the corneal and conjunctival epithelium. The cornea and conjunctiva were divided into 3 and 2 fractions, respectively, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better.~The change from baseline at the end of instillation (LOCF) in the keratoconjunctival staining score were compared between the 2% rebamipide group and the 0.1% sodium hyaluronate group using a t-test."|Basekine, 4 weeks||||scores on a scale||Standard Deviation|Mean
2669726|NCT01493167|Primary|Efficient Casting With Woodcast Circular System|Efficient casting conduc ted with Novel Woodcast material|1 - 6 weeks||||participants|||Number
2669715|NCT01493414|Secondary|Time to First Improvement in FACT-Lym, FACIT-Fatigue Score and ECOG Performance Status|Improvement was defined by the upper limit of the minimally important difference (MID). Patients with the best possible score at Baseline were excluded from this analysis because their HRQoL cannot be further improved. Responders and non-responders for each endpoint were defined based on change from baseline scores using pre specified cut-off points. Patients with an improved score compared to Baseline, for which the magnitude of the change was at least the cutoff value, were classified as responders; otherwise, as non-responders. The responder cutoff: ECOG cutoff=1, range=0 to 5, FACT-Lym cutoff=5.4, range 0-60, FACIT-Fatigue =5 and range=0-52.The median time to first improvement was estimated using the Kaplan Meier method and time to improvement event was determined based on upper bound of the MID. The time to improvement was calculated from the date of first study drug administration.|Baseline up to approximately 5 years|Full analysis set includes all patients who received at least one administration of study drug.|||weeks||95% Confidence Interval|Median
2669716|NCT01493414|Secondary|Change in Functional Assessment of Cancer Therapy (FACT-TOI, FACT-G) and FACT-Lymphoma (FACT-Lym) Total Scores Measured at Baseline and Week 48|The FACT-Lym questionnaire consists of a total of 42 questions divided between five subscales (i.e., physical well-being, social/family well-being, emotional well-being, functional well-being and lymphoma subscale). Each subscale questionnaire rates each question on a 5-point scale from 0 = Not at all to 4 = Very much. These scores were summed to three total sum scores, namely FACT-Lym score, FACT-Lym Trial Outcome Index (TOI), FACT-General (FACT-G) and FACT-Lym total score. Total scores: FACT-Lym=0-60, FACT-TOI=0-116, FACT-G total=0-108, FACT-Lym Total= 0-168. Higher scores are reflective of better HRQoL.|Baseline and Week 48|Full analysis set includes all patients who received at least one administration of study drug.|||scores on a scale||Standard Deviation|Mean
2669717|NCT01493414|Secondary|Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to Worst Post-baseline ECOG Status up to 5 Years|ECOG Performance Score has 5 grades. 0 = Fully active, able to carry out all pre-disease activities; 1 = Restricted in strenuous activity but ambulatory and able to carry out work of light or sedentary nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Active about 50% of waking hours; 3 = Capable of limited self-care, confined to bed/chair more than 50% of waking hours; 4 = Completely disabled; cannot carry on self-care. Totally confined to bed/chair. 5 = Death.|Baseline up to approximately 5 years|Full analysis set includes all patients who received at least one administration of study drug.|||Participants|||Count of Participants
2669718|NCT01493414|Secondary|Number of Participants With Best Overall Response (BOR) up to 5 Years According to Spleen Length|"Overall response is analyzed using the spleen response, as assessed by the investigator and also by deriving the response using International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria.~Participants with spleen length at baseline between 5 and 10 cm were reported as Responders if reporting non palpable spleen; Stable disease does not meet criteria for response or disease progression and Progressive disease with an increase of 100% from baseline in spleen length.~Participants with spleen length at baseline more than 10 cm were reported as Responders with spleen reduction of 50% from baseline; Stable disease does not meet criteria for response or disease progression and Progressive disease with an increase of 50% from baseline in spleen length."|Baseline up to approximately 5 years|Full analysis set includes all patients who received at least one administration of study drug and were observed from baseline in to the study follow-up period.|||Participants|||Count of Participants
2669719|NCT01493414|Secondary|Percentage of Participants With at Least 50% Reduction in Spleen Length|Spleen length was assessed by manual palpation. Assessment of spleen response was repeated until early discontinuation of the study drug and also at study completion (28 days post end of treatment visit).|Baseline up to approximately 5 years|Full analysis set includes all patients who received at least one administration of study drug.|||percentage of participants||95% Confidence Interval|Number
2669720|NCT01493414|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 5 Years|An adverse event (AE) is any untoward medical occurrence in a clinical trial participant regardless of causal relationship to study drug and regardless whether study drug has been administered. A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. A non-serious AE is any AE that does not meet the criteria above.|Baseline up to approximately 5 years|Safety set includes all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.|||Participants|||Count of Participants
2669721|NCT01493284|Secondary|Number of Participants With Acute Device Success|"Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system~Correct position of the device in the proper anatomical location~Intended performance of the prosthetic heart valve (Aortic Valve Area >1.2 cm2 and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, without moderate or severe prosthetic valve AR)~Only one valve implanted in the proper anatomical location"|7 days|Successful vascular access, delivery and deployment of the device|||Participants|||Count of Participants
2669722|NCT01493284|Secondary|Participant NYHA Classification at Day 30|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. Patients with cardiac disease but without resulting limitation of physical activity.~Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.~Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.~Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.~The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown & Co; 1994:253-256."|day 30|Analysis for participants that completed visit and assessment|||Participants|||Count of Participants
2669723|NCT01493284|Secondary|Number of Select Cardiovascular Adverse Events|Number of participants with select cardiovascular adverse events|30 days||||participants|||Number
2669724|NCT01493284|Primary|All Cause Mortality|Number of participants that reported all cause mortality|30 days||||Participants|||Count of Participants
2669733|NCT01493024|Secondary|24-hour Urinary Excretion of Creatinine|24-hour urinary excretion of creatinine on Study Days 1 and Day 2|48 hours|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mg/24 hour||Standard Deviation|Mean
2669734|NCT01493024|Secondary|24-hour Urinary Excretion of Urea Nitrogen|24-hour urinary excretion of urea nitrogen on Study Days 1 and Day 2|48 hours|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||g/24 hour||Standard Deviation|Mean
2669735|NCT01493024|Secondary|24-hour Urinary Excretion of Sodium|24-hour urinary excretion of sodium on Study Days 1 and Day 2|48 hours|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mmol/24 hour||Standard Deviation|Mean
2669736|NCT01493024|Secondary|24-hour Urinary Excretion of Potassium|24-hour urinary excretion of potassium on Study Days 1 and Day 2|24 and 48 hours post study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mmol/24 hour||Standard Deviation|Mean
2669737|NCT01493024|Secondary|Serum Bicarbonate (HCO3) Levels|Serum bicarbonate compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 & 48 hours post dose on Study Days 2 and 3).|24 and 48 hours post study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mmol/L||Standard Deviation|Mean
2669738|NCT01493024|Secondary|Serum Sodium (S-Na) Levels|Serum sodium compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 & 48 hours post dose on Study Days 2 and 3).|24 and 48 hours post study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mmol/L||Standard Deviation|Mean
2669739|NCT01493024|Secondary|Serum Calcium (S-Ca) Levels|Serum calcium compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 & 48 hours post dose on Study Days 2 and 3).|24 and 48 hours post study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mg/dL||Standard Deviation|Mean
2669740|NCT01493024|Secondary|Serum Magnesium (S-Mg) Levels|Serum magnesium compared between the combined placebo-treated controls and the ZS-treated subjects (measured at 24 & 48 hours post dose on Study Days 2 and 3).|24 and 48 hours post study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mg/dL||Standard Deviation|Mean
2669741|NCT01493024|Secondary|Blood Urea Nitrogen|Blood urea nitrogen compared between the combined placebo-treated controls and the ZS-treated subjects (measured 24 & 48 hours post dose on Study Days 2 and 3).|24 and 48 hours post study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mg/dL||Standard Deviation|Mean
2669742|NCT01493024|Secondary|Urea Nitrogen Excretion|Urea nitrogen excretion compared between the combined placebo-treated controls and the ZS-treated subjects (measured throughout two 24-hour periods on Study Days 1 and 2).|24 and 48 hours post study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mg/dL||Standard Deviation|Mean
2669743|NCT01493024|Secondary|Urine Potassium Excretion|Urine potassium excretion compared between the combined placebo-treated controls and the ZS-treated subjects (measured throughout two 24-hour periods on Study Days 1 and 2).|24 and 48 hours post study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mmol/L||Standard Deviation|Mean
2669744|NCT01493024|Secondary|Urine Sodium Excretion|Urine sodium excretion compared between the combined placebo-treated controls and the ZS-treated subjects (measured throughout two 24-hour periods on Study Days 1 and 2).|24 and 48 hours post first study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mmol/L||Standard Deviation|Mean
2669745|NCT01493024|Secondary|Percentage of Participants With Normal S-K Levels at End of Study Day 2|Percentage (%) of subjects who achieve S-K normalization at end of Study Day 2|48 hours post first study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||percentage of participants|||Number
2669746|NCT01493024|Secondary|Time Specific Decreases in S-K Levels of > = 0.5 mmol/L|Percentage of participants achieving a 0.5mmol/L drop from baseline at Study Days 2 and 3 at 0 hr.|24 and 48 hours post first study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||percentage of participants|||Number
2669747|NCT01493024|Secondary|Time Specific S-K Levels to Normalization|Percent of subjects achieving S-K normalization (<=as defined by S-K levels of 3.5 to 4.9 mmol/L) from baseline at Study Days 2 and 3 at 0 hr.|48 and 72 hours post first study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||percentage of participants|||Number
2669748|NCT01493024|Secondary|Serum Potassium (S-K) at Individual Time Points.|Serum potassium (S-K) at individual time points through Study day 3/0hour.|First 48 hours of study|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||mmol/L||Standard Deviation|Mean
2669749|NCT01493024|Primary|Difference in the Exponential Rate of Change in Serum Potassium (S-K) Levels Versus Placebo During the Initial 48 Hours of Study Drug Treatment|The rate of fall in S-K levels during the initial 48 hours of study drug treatment between the placebo treated subjects and the ZS treated subjects measured on a log scale|24 and 48 hours post first study drug dose|Intent-to-treat (ITT) population: all subjects that were randomized, received any investigational product, and had S-K levels determined at 48 hours.|||log(mmol/L/hour)||Standard Error|Mean
2671476|NCT01475955|Primary|Complete Clearance Rate|The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 12|Intent to Treat (ITT) with last observation carried forward (LOCF) to impute missing data|||participants|||Number
2669750|NCT01492686|Secondary|Percentage of Participants With Abnormal Values in Sensory Examinations||baseline and 24 weeks|"A note:~Four patients of Placebo of MCI-186 group did not have data at 24 week. Therefore, concerning numbness (at 24 week) and staggering (at 24 week), the number of participants analysed are 64 in the both groups."|||percentage of Participants|||Number
2669751|NCT01492686|Secondary|"Laboratory Tests Percentage of Participants With Adverse Events by System Organ Class (SOC) of Investigations (PT, MedDRA Ver. 17.0)"||24 weeks||||percentage of Participants|||Number
2669752|NCT01492686|Secondary|Percentage of Participants With Adverse Drug Reactions||24 weeks||||percentage of Participants|||Number
2669753|NCT01492686|Secondary|Percentage of Participants With Adverse Events||24 weeks||||percentage of Participants|||Number
2669754|NCT01492686|Secondary|Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks|The ALSAQ40 score is a measure of QoL for patients with ALS. The ALSAQ40 evaluates domains that include physical mobility, Activities of daily living (ADL) and independence, eating and drinking, communication, and emotional reactions. 200=worst; 40=best|baseline and 24 weeks|"1 patient who did not reach the end of cycle 3 was excluded from the FAS in the MCI-186 group.~2 patients who did not reach the end of cycle 3 and 2 patient with missing data were excluded from the FAS in the Placebo of MCI-186 group."|||units on a scale||Standard Error|Least Squares Mean
2669755|NCT01492686|Secondary|Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks|The Modified Norris Scale is a measure of movement disorder for patients with ALS. 0=worst; 102=best|baseline and 24 weeks|"1 patient who did not reach the end of cycle 3 was excluded from the FAS in the MCI-186 group.~2 patients who did not reach the end of cycle 3 and 3 patient with missing data were excluded from the FAS in the Placebo of MCI-186 group."|||units on a scale||Standard Error|Least Squares Mean
2669756|NCT01492686|Secondary|Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks||baseline and 24 weeks|"1 patient who did not reach the end of cycle 3 and 1 patient with missing data were excluded from the FAS in the MCI-186 group.~2 patients who did not reach the end of cycle 3 were excluded from the FAS in the Placebo of MCI-186 group."|||percentage of FVC||Standard Error|Least Squares Mean
2669757|NCT01492686|Secondary|Number of Participants With Death or a Specified State of Disease Progression|"Any of death, disability of independent ambulation, loss of upper limbs function, tracheotomy, use of respirator, use of tube feeding and loss of useful speech was defined as an event."|24 weeks||||Count of Participants|||Number
2669758|NCT01492686|Primary|Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks|0=worst; 48=best|baseline and 24 weeks|"1 patient who did not reach the end of cycle 3 was excluded from the FAS in the MCI-186 group.~2 patients who did not reach the end of cycle 3 were excluded from the FAS in the Placebo of MCI-186 group."|||units on a scale||Standard Error|Least Squares Mean
2669759|NCT01492673|Secondary|Number of Participants With Adverse Events|Safety will be assessed by physical examination, interim history, and laboratory assessments. Adverse events will be graded according to the NCI-CTCAE, version 4.0|2 years||||Participants|||Count of Participants
2669760|NCT01492673|Primary|Objective Response Rate|"as measured by objective response rate (CR/PR) after 2 cycles of treatment and duration of response. after 2 cycles of treatment and duration of response according to the Revised RECIST guideline (version 1.1)~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|2 years|Data were not collected. Study terminated due to low accrual.||||||
2669761|NCT01492582|Primary|Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation])|To demonstrate comparable safety/tolerability of the HPV vaccine in cancer survivors ages 9 to 26 years when compared to age- and sex-matched general population.|Dose 1 through Month 7|Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.|||participants|||Number
2669762|NCT01492582|Primary|Immunogenicity of the HPV Vaccine in Cancer Survivors (Anti-HPV 16 and 18 Geometric Mean Titers) (Aim 2 [Vaccine Evaluation])|To demonstrate the non-inferiority of the antibody responses to the HPV vaccine in cancer survivors ages 9 to 26 years when compared to antibody responses of age- and sex-matched historical healthy population.|1 month following vaccination dose #3||||mMu/mL||Standard Deviation|Geometric Mean
2669763|NCT01492582|Primary|Prevalence of HPV Vaccine Initiation in Cancer Survivors (Aim 1 [Survey])|The prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years|At baseline|Participants who returned an evaluable survey|||Participants|||Count of Participants
2669764|NCT01492439|Secondary|The Digit Vigilance Test at 6 Months|The Digit Vigilance test measures sustained attention/vigilance. Participants are asked to cross out either 6s or 9s which appear randomly within 59 rows of 35 single digits. Scores are calculated for Total Time and Total Errors, with higher scores indicating greater impairment.|6 months following baseline assessment||||Seconds||Standard Deviation|Mean
2669765|NCT01492439|Secondary|The Digit Vigilance Test at 6 Months|The Digit Vigilance test measures sustained attention/vigilance. Participants are asked to cross out either 6s or 9s which appear randomly within 59 rows of 35 single digits. Scores are calculated for Total Time and Total Errors, with higher scores indicating greater impairment.|6 months following baseline assessment||||Incorrect Responses||Standard Deviation|Mean
2669766|NCT01492439|Secondary|The Digit Vigilance Test at 3 Months|The Digit Vigilance test measures sustained attention/vigilance. Participants are asked to cross out either 6s or 9s which appear randomly within 59 rows of 35 single digits. Scores are calculated for Total Time and Total Errors, with higher scores indicating greater impairment.|3 months following baseline assessment||||Seconds||Standard Deviation|Mean
2669767|NCT01492439|Secondary|The Digit Vigilance Test at 3 Months|The Digit Vigilance test measures sustained attention/vigilance. Participants are asked to cross out either 6s or 9s which appear randomly within 59 rows of 35 single digits. Scores are calculated for Total Time and Total Errors, with higher scores indicating greater impairment.|3 months following Baseline assessment||||Incorrect Responses||Standard Deviation|Mean
2669768|NCT01492439|Secondary|The Wisconsin Card Sorting Task at 6 Months|The WCST is a commonly used test of executive functioning that measures cognitive flexibility and problem solving skills. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.|6 months following baseline assessment||||Correct responses||Standard Deviation|Mean
2669769|NCT01492439|Secondary|The Wisconsin Card Sorting Task at 6 Months|The WCST is a commonly used test of executive functioning that measures cognitive flexibility and problem solving skills. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to the overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.|6 months following Baseline assessment||||Percentage of responses||Standard Deviation|Mean
2669770|NCT01492439|Secondary|The Wisconsin Card Sorting Test at 3 Months|The Wcst is a commonly used test of executive functioning that measures cognitive flexibility and problem solving skills. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.|3 months following Baseline assessment||||Correct responses||Standard Deviation|Mean
2669771|NCT01492439|Secondary|The Wisconsin Card Sorting Test at 3 Months|The WCST is a commonly used test of executive functioning that measures cognitive flexibility and problem solving skills. The 'number of categories' measures the number of correct responses. The percentage of perseverative errors provides the concentration of perseverative errors in relation to the overall test performance. The percentage conceptual level response provides the percentage of consecutive correct responses in runs of 3 or more.|3 months following Baseline assessment||||Percentage of responses||Standard Deviation|Mean
2669772|NCT01492439|Secondary|The Trail Making Part B at 6 Months|The Trail Making Test Part B assesses executive function. Trail Making Part B is similar to Part A but is a more challenging task because it requires subjects to connect consecutively numbered and lettered circles by alternating between the 2 sequences. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.|6 months following Baseline assessment||||Seconds||Standard Deviation|Mean
2669773|NCT01492439|Secondary|The Trail Making Test Part B at 3 Months|The Trail Making Test Part B assesses executive function. Trail Making Part B is similar to Part A but is a more challenging task because it requires subjects to connect consecutively numbered and lettered circles by alternating between the 2 sequences. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.|3 months following Baseline assessment||||Seconds||Standard Deviation|Mean
2669774|NCT01492439|Secondary|The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 6 Months|Short term memory will be evaluated with the digit span subtest of the Wechsler Adult Intelligence Scale-III. Participants are asked to recall a sequence of numbers, starting with 2 and increasing to a sequence of 9 numbers. If the participant repeats the sequence correctly they score a one, if incorrect then score a zero. There are two lists, one to be repeated forwards and the other backwards. The total score is a sum of sequences recalled correctly.|6 months following Baseline assessment||||Correct responses||Standard Deviation|Mean
2669775|NCT01492439|Secondary|The Digit Span Subtest of the Wechsler Adult Intelligence Scale - III at 3 Months|Short term memory will be evaluated with the digit span subtest of the Wechsler Adult Intelligence Scale-III. Participants are asked to recall a sequence of numbers, starting with 2 and increasing to a sequence of 9 numbers. If the participant repeats the sequence correctly they score a one, if incorrect then score a zero. There are two lists, one to be repeated forwards and the other backwards. The total score is a sum of sequences recalled correctly.|3 months following Baseline assessment||||Correct responses||Standard Deviation|Mean
2669776|NCT01492439|Secondary|The Trail Making Test Part A at 6 Months|The Trail Making Test Part A is a test involving using lines to connect numbers, it will be used to assess scanning ability and psychomotor speed. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.|6 months following Baseline assessment||||Seconds||Standard Deviation|Mean
2669777|NCT01492439|Secondary|The Trail Making Test Part A at 3 Months|The Trail Making Test Part A is a test involving using lines to connect numbers, it will be used to assess scanning ability and psychomotor speed. For this timed test, participants are scored by the number of seconds taken to complete the task, with high scores revealing greater impairment.|3 months following Baseline assessment||||Seconds||Standard Deviation|Mean
2669778|NCT01492439|Secondary|The California Verbal Learning Test at 6 Months|Verbal learning and memory will be assessed with the California Verbal Learning Test. A 9 word list is read to the participant (List A). Participants are asked to immediately free recall List A over 4 trials, then recall after a distractor task (short delay), then after a long delay.In the cued recall section, participants are asked to recall by category. In the long delay yes/no recognition, participants are asked to recall List A items out of a 27 word list. Higher repetitions and intrusions reveal greater impairment.|6 months following Baseline assessment||||Correct responses||Standard Deviation|Mean
2669779|NCT01492439|Secondary|The California Verbal Learning Test at 3 Months|Verbal learning and memory will be assessed with the California Verbal Learning Test. A 9 word list is read to the participant (List A). Participants are asked to immediately free recall List A over 4 trials, then recall after a distractor task (short delay), then after a long delay.In the cued recall section, participants are asked to recall by category. In the long delay yes/no recognition, participants are asked to recall List A items out of a 27 word list. Higher repetitions and intrusions reveal greater impairment.|3 months following Baseline Assessment||||Correct responses||Standard Deviation|Mean
2669780|NCT01492439|Secondary|The Rosenberg Self-Esteem Scale Score at 6 Months|The Rosenberg Self Esteem Scale measures self esteem. This is a ten item, four point Likert scale with scores ranging from strongly agree to strongly disagree. Scores can range from 0-30. Total sum scores between 15 and 25 are within normal range; with scores below 15 suggest low self-esteem.|6 months following Baseline assessment||||units on a scale||Standard Deviation|Mean
2669781|NCT01492439|Secondary|The Positive and Negative Symptoms Scale (PANSS) Score at 6 Months|Symptoms of psychosis will be assessed using the Positive and Negative Syndrome Scale. The 30 item scale is comprised of 3 subscales measuring positive, negative and general psychopathology symptoms. Each item is scored using 7 anchoring criteria; 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores for the positive scale range from 7-49, the negative scale from 7-49, and general psychopathology 16-112, with total summed scores ranging from 30-210. 95>high, 75-95 medium and <75 low symptomology.|6 months following Baseline assessment||||units on a scale||Standard Deviation|Mean
2669782|NCT01492439|Secondary|The Rosenberg Self-Esteem Scale Score at 3 Months|The Rosenberg Self Esteem Scale measures self esteem. This is a ten item, four point Likert scale with scores ranging from strongly agree to strongly disagree. Scores can range from 0-30. Total sum scores between 15 and 25 are within normal range; with scores below 15 suggest low self-esteem.|3 months following Baseline||||units on a scale||Standard Deviation|Mean
2669783|NCT01492439|Secondary|Positive and Negative Symptoms Scale (PANSS) Score at 3 Months|Symptoms of psychosis will be assessed using the Positive and Negative Syndrome Scale. The 30 item scale is comprised of 3 subscales measuring positive, negative and general psychopathology symptoms. Each item is scored using 7 anchoring criteria; 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Scores for the positive scale range from 7-49, the negative scale from 7-49, and general psychopathology 16-112, with total summed scores ranging from 30-210. 95>high, 75-95 medium and <75 low symptomology.|3 months following baseline||||units on a scale||Standard Deviation|Mean
2669784|NCT01492439|Primary|Completion of Academic Semesters|During the study period, course instructors provided information as to whether participants had completed or withdrawn from academic semester 1 and 2. This data was used to determine whether completion of academic semesters might be explained by attending cognitive remediation alongside supported education. At the end of the each semester, course instructors notified the research team as to whether participants had completed or not completed the academic semester. The unit of measure, 'course completed' refers to the completion of the required number of courses in that academic semester to progress through to the next semester.|The end of the semester 1 (3 months following baseline) and semester 2 (6 months following baseline)||||Courses completed||Standard Deviation|Mean
2669785|NCT01492426|Secondary|Percentage of Genotype 1a Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 12 of treatment.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1a participants assessed for SVR12 response.|||Percentage of participants||95% Confidence Interval|Number
2669786|NCT01492426|Secondary|Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 24 (SVR24)|SVR24 was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up week 24 of treatment.|Week 24 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for SVR24 response.|||Percentage of participants||95% Confidence Interval|Number
2669787|NCT01492426|Secondary|Percentage of Genotype 1b Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at Week 12 of treatment.|Week 12|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for cEVR response.|||percentage of participants||95% Confidence Interval|Number
2669788|NCT01492426|Secondary|Percentage of Genotype 1b Participants With Extended Rapid Virologic Response (eRVR) at Both Week 4 and Week 12|eRVR was defined as hepatitis C virus RNA levels lower than the lower limit of quantitation, ie, 25 IU/mL target not detected at both Weeks 4 and 12 of treatment.|Week 4, Week 12|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for eRVR response.|||Percentage of participants||95% Confidence Interval|Number
2669789|NCT01492426|Secondary|Percentage of Genotype 1b Participants With Rapid Virologic Response (RVR) at Week 4|RVR was defined as hepatitis c virus RNA levels lower than lower limit of quantitation, ie, 25 IU/mL target not detected at Week 4 of treatment.|Week 4|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for RVR response.|||Percentage of participants||95% Confidence Interval|Number
2669790|NCT01492426|Primary|Percentage of Genotype 1b Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as hepatitis C virus RNA levels to be lower than the limit of quantitation, ie, 25 IU/mL target detected or target not detected at follow-up Week 12.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, 'Number of participants analysed' signifies Genotype 1b participants assessed for SVR12 response.|||Percentage of participants||95% Confidence Interval|Number
2669791|NCT01492400|Secondary|Change From Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA)|FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. A negative change from baseline indicates a decrease in leakage (improvement) and a positive change from baseline indicates an increase in leakage (worsening).|Baseline, Month 12|Intent-to-Treat: all randomized patients|||Square Millimeters (mm^2)||Standard Deviation|Mean
2669792|NCT01492400|Secondary|Change From Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye|OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina) in the study eye after pupil dilation. A negative change from baseline indicates an improvement (less foveal thickness) and a positive change from baseline indicates a worsening (more foveal thickness).|Baseline, Month 12|Intent-to-Treat: all randomized patients|||Microns||Standard Deviation|Mean
2669793|NCT01492400|Primary|Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.|Baseline, 12 Months|Intent-to-Treat: all randomized patients|||Letters||Standard Deviation|Mean
2669794|NCT01492309|Secondary|Change in Brain Derived Neurotrophic Factor (BDNF) With Active Transcranial Magnetic Simulation (TMS)|We measured the levels of Brain Derived Neurotrophic Factor (BDNF) concentration across time. BDNF is a protein thought to regulate mood and cognitive functioning and research has suggested that levels may vary by severity of mood symptoms. We obtained BDNF values on test days 1 & 20.|Change in concentration from test day 1 to test day 20|Only 4 participants from both the active and sham TMS groups were used in analysis because these participants had BDNF data at both time points. Furthermore, some samples were deemed unusable.|||pg/mL||Standard Deviation|Mean
2669795|NCT01492309|Primary|Change in Hamilton Rating Scale for Depression (HDRS-17) Scores Pre- and Post- Treatment|We measured changes in Hamilton Rating Scale for Depression (HDRS-17) scores from baseline to post-treatment. The HDRS-17 was administered on test days 1, 10, & 20. Scoring is based on the 17-item scale and scores of 0-7 is generally accepted to be within the normal range, indicating minimal to no depression; scores of 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.|Change score from baseline to test day 20 (after 20 days of intervention)||||difference in units on a scale||Standard Deviation|Mean
2669796|NCT01492088|Secondary|Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2)|Blood samples were collected and tested for MMAE plasma concentrations.|Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose|PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Cycle 2 Day 2 values are collected in phase 1 participants only. Here, number analyzed is number of participants assessed at given time-point. Data summarized together for all participants in brentuximab vedotin 1.8 mg/kg arm.|||ng/mL||Standard Deviation|Mean
2669797|NCT01492088|Secondary|Serum Concentration of Total Antibodies (Conjugated and Unconjugated)|Blood samples were collected and tested for conjugated and unconjugated antibodies.|Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose|PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Cycle 2 Day 2 values are collected in phase 1 participants only. Here, number analyzed is number of participants assessed at given time-point. Data summarized together for all participants in brentuximab vedotin 1.8 mg/kg arm.|||ug/mL||Standard Deviation|Mean
2669798|NCT01492088|Secondary|Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2)|Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.|Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose|PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Cycle 2 Day 2 values are collected in phase 1 participants only. Here, number analyzed is number of participants assessed at given time-point. Data summarized together for all participants in brentuximab vedotin 1.8 mg/kg arm.|||ug/mL||Standard Deviation|Mean
2669799|NCT01492088|Secondary|Number of Participants With Clinically Significant Vital Signs Reported as AEs (Phase 1 and 2)|Vital signs measurements included supine (after 3-5 minutes in this position) and standing (after 3-5 minutes in this position) measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.|From the first dose through 30 days after the last dose of study medication (Up to 15 months)|Safety population is defined as all participants who received at least 1 dose of study drug. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.|||Participants|||Count of Participants
2669800|NCT01492088|Secondary|Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2)|Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.|From the first dose through 30 days after the last dose of study medication (Up to 15 months)|Safety population is defined as all participants who received at least 1 dose of study drug. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.|||Participants|||Count of Participants
2669801|NCT01492088|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1 and 2)|An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.|From the first dose through 30 days after the last dose of study medication (up to 15 months)|Safety population is defined as all participants who received at least 1 dose of study drug. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.|||Participants|||Count of Participants
2669802|NCT01492088|Secondary|Overall Survival (OS) (Phase 1 and 2)|OS is the time in months from start of study treatment to date of death due to any cause.|Every 6 months after EOT, until the sooner of death, study closure, or 2 years after enrolment of the last participant (Up to 72 months)|Safety population is defined as all participants who received at least 1 dose of study drug.|||months||95% Confidence Interval|Median
2671524|NCT01475513|Secondary|Change From Baseline in Fasting Glucose at 6 Months|Higher fasting glucose indicate an increased metabolic risk|Baseline, 6 months||||mg/dL||95% Confidence Interval|Mean
2669803|NCT01492088|Secondary|Progression Free Survival (PFS) (Phase 1 and 2)|PFS is defined as time in months from start of study treatment to first documentation of objective tumor progression per IRF assessment or up to death due to any cause, whichever occurs first. PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death or end of study (Up to 72 months)|Safety population is defined as all participants who received at least 1 dose of study drug. PFS was censored on the day following the date of last radiological assessment of measured lesions documenting absence of PD for participants who did not have tumor progression.|||months||95% Confidence Interval|Median
2669804|NCT01492088|Secondary|Event Free Survival (EFS) (Phase 1 and 2)|EFS is defined as the time in months from first dose until any cause of treatment failure: disease progression, premature discontinuation of treatment for any reason, or death due to any cause, whichever occurs first. PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)|Safety population is defined as all participants who received at least 1 dose of study drug. EFS was censored on the last follow-up date if none of the above events occur during the study.|||months||95% Confidence Interval|Median
2669805|NCT01492088|Secondary|Duration of Response (DOR) (Phase 1 and 2)|DOR is defined as the time in months from the date of first documentation of a CR or PR to the date of first documentation of tumor progression or PD per IRF assessment according to IWG criteria or to death due to any cause, whichever comes first. CR is defined as the disappearance of all evidence of disease and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death or end of study (Up to 72 months)|Participants with response from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis. Duration of response was censored at last observation documenting absence of PD for participants who did not have tumor progression.|||months||95% Confidence Interval|Median
2669806|NCT01492088|Secondary|Time to Response (Phase 1 and 2)|Time to response is defined as the time in months from the first dose of study treatment until the date of the first assessment of confirmed CR or PR. as assessed by an IRF using IWG revised response criteria for malignant lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months)|Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Time to response was censored on the last radiological assessment of measured lesions documenting absence of CR or PR for participants who did not have CR or PR.|||months||95% Confidence Interval|Median
2669807|NCT01492088|Secondary|Time to Progression (TTP) (Phase 1 and 2)|TTP is defined as the time in months from first dose until the first subsequent documentation of objective tumor progression. Progressive disease (PD) is defined as any new lesion or increase by ≥50% of previously involved sites from nadir.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)|Safety population is defined as all participants who received at least 1 dose of study drug. TTP was censored on last radiological assessment of measured lesions documenting absence of PD for participants who did not have tumor progression.|||months||95% Confidence Interval|Median
2669808|NCT01492088|Secondary|Overall Response Rate (ORR) (Phase 1)|Overall response rate is defined as the percentage of participants with CR or PR as assessed by an IRF using IWG Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months)|Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Participants enrolled in Phase 1 of the study were evaluated for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2669809|NCT01492088|Secondary|Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing ATA (nATA) (Phase 1 and 2)|Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA and nATA development) using a laboratory test. ATA-positive samples were further characterized as transiently ATA positive (defined as 1 or 2 post-Baseline ATA-positive responses), persistently ATA positive (defined as more than 2 post-Baseline ATA positive responses), and nATA positive or negative.|Baseline up to EOT (Up to 15 months)|Participants from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis.|||Participants|||Count of Participants
2669810|NCT01492088|Primary|Overall Response Rate (ORR) (Phase 1 and 2)|Overall response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.|Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or end of treatment (EOT) (Up to 15 months)|Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.|||percentage of participants||95% Confidence Interval|Number
2669811|NCT01492088|Primary|Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1)|Blood samples were collected and tested for MMAE plasma concentrations.|Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose|Data for this outcome measure was not summarized for Phase 1 participants only, data was summarized together for Phase 1 and 2 participants in brentuximab 1.4 mg/kg and 1.8 mg/kg arms groups. Data has been presented in OM 21.||||||
2671525|NCT01475513|Secondary|Change From Baseline in Fasting Insulin at 6 Months|Higher fasting insulin values indicate an increased metabolic risk|Baseline, 6 months||||uIU/ mL||95% Confidence Interval|Mean
2669812|NCT01492088|Primary|Serum Concentration of Total Antibodies (Conjugated and Unconjugated) (Phase 1)|Blood samples were collected and tested for conjugated and unconjugated antibodies.|Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose|Data for this outcome measure was not summarized for Phase 1 participants only, data was summarized together for Phase 1 and 2 participants in brentuximab 1.4 mg/kg and 1.8 mg/kg arms groups. Data has been presented in OM 20.||||||
2669813|NCT01492088|Primary|Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1)|Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.|Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose|Data for this outcome measure was not summarized for Phase 1 participants only, data was summarized together for Phase 1 and 2 participants in brentuximab 1.4 mg/kg and 1.8 mg/kg arms groups. Data has been presented in OM 19.||||||
2669814|NCT01492088|Primary|Number of Participants With Clinically Significant Vital Signs Values Reported as AEs (Phase 1)|Vital signs measurements included supine (after 3-5 minutes in this position) and standing (after 3-5 minutes in this position) measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.|From the first dose through 30 days after the last dose of study medication (Up to 15 months)|Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.|||Participants|||Count of Participants
2669815|NCT01492088|Primary|Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1)|Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.|From the first dose through 30 days after the last dose of study medication (Up to 15 months)|Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.|||Participants|||Count of Participants
2669816|NCT01492088|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.|From the first dose through 30 days after the last dose of study medication (Up to 15 months)|Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.|||Participants|||Count of Participants
2669817|NCT01491984|Secondary|Time to Successful Intubation|Time to successful intubation was documented during the second laryngoscopy and defined as the time from the insertion of the Macintosh laryngoscope into the oral cavity to its removal.|intraoperative|||||||
2669818|NCT01491984|Secondary|Operator Rating of Difficulty|The attending anesthesiologist rated the difficulty in using each technique to intubate the larynx using an 11-point numeric rating scale and a 4-point visual rating scale.|intraoperative|||||||
2669819|NCT01491984|Secondary|Number of Intubation Attempts|Number of intubation attempts was recorded after intubation was completed.|intraoperative|||||||
2669820|NCT01491984|Primary|Cormack-Lehane Grade|"The anesthesiologist graded the laryngeal view after induction of anesthesia using Cormack-Lehane Scale.~Grade 1 = full view of glottis Grade 2a = partial view of glottis Grade 2b = Only posterior extremity of glottis seen or only arytenoid cartilages Grade 3 = Only epiglottis seen, none of glottis seen Grade 4 = Neither glottis nor epiglottis seen"|intraoperative||||participants|||Number
2669821|NCT01491958|Secondary|Non Relapse Mortality (NRM) at One Year|Cumulative incidence of NRM will be calculated as the time from transplant until death not related to disease, where the competing risk for NRM was death due to disease. Patients who had not died were censored at last follow up.|up to 12 months post transplant||||percentage of patients||95% Confidence Interval|Number
2669822|NCT01491958|Secondary|Percentage of Patients With Chronic Graft Versus Host Disease (cGVHD)|cGVHD occurring anytime after day 100 post transplant will be termed chronic GVHD, and evaluated in patients who were followed for at least 100 days without early progression or death. Grading of cGVHD was done using the National Institutes of Health Consensus Development Project Criteria|up 1 year post transplant||||percentage of patients||95% Confidence Interval|Number
2669823|NCT01491958|Secondary|Time to Neutrophil and Platelet Engraftment|Neutrophil engraftment will be defined as first of three consecutive days with ANC ≥ 0.5 x 109/L post-conditioning regimen induced nadir. Similarly platelet engraftment is defined as first day of platelet count ≥ 20,000 x 109/L, without transfusion for 7 consecutive days.|weekly for 12 weeks, 100 days, 6 months, and 12 months||||days||Full Range|Median
2669824|NCT01491958|Secondary|Safety of Atorvastatin in Transplant Recipients in Terms of Adverse Events and Toxicities.|Adverse events and toxicities were monitored in patients using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 criteria.|Patients: Baseline, weekly for 9 weeks and then on days 84, 91-100, 180 and 365. Donors: at apheresis and then 30 days later.|Only patients with evaluable data reported|||patients|||Number
2669825|NCT01491958|Primary|Percentage of Participants With Grades II to IV aGVHD at Day +100 of Atorvastatin Administration|The incidence of grades II to IV aGVHD at day +100 of atorvastatin administration. The grading of aGVHD and cGVHD were done using the Consensus Conference criteria.|Up through day 100 following transplant||||percentage of patients||95% Confidence Interval|Number
2669840|NCT01491893|Secondary|Median Progression-free Survival (PFS)|PFS is defined as the time in months between the administration of PVSRIPO and the first occurrence of disease progression. PFS will be defined radiologically, if possible, or alternatively defined by a significant overall change (deterioration) in clinical status.|5 years||2020-06-30|06/2020||||
2669826|NCT01491919|Secondary|Change in Diastolic Blood Pressure From Baseline in Lisinopril SOC Group|Lisinopril SOC participants were not given the ambulatory blood pressure machine to obtain readings at home, as was the Lisinopril-naive participants. Instead BP measurements were obtained during screening visit and compared to the Day 14 to 40 visit measurements (note: the participants were not required to attend a Day 14 (+/-3 day visit) but did need to attend sometime between Day 14 to Day 40. The mean from the blood pressure measurements was calculated.|Screening to Day 14 to 40|Change in diastolic blood pressure from baseline is reported here for lisinopril SOCparticipants (not the Lisinopril-naive group which are reported separately).|||mmHg||Standard Deviation|Mean
2669827|NCT01491919|Secondary|Change in Systolic Blood Pressure (BP) From Baseline in Lisinopril SOC Group|Lisinopril SOC participants were not given the ambulatory blood pressure machine to obtain readings at home, as was the Lisinopril-naive participants. Instead BP measurements were obtained during screening visit and compared to the Day 14 to 40 visit measurements. Note: these participants were not required to attend a Day 14 (+/-3 day visit) but did need to attend sometime between Day 14 to Day 40 (inclusive). The mean of these blood pressure measurements was calculated.|Screening to Day 14 to 40|Change in systolic blood pressure from baseline is reported here for lisinopril SOCparticipants (not the Lisinopril-naive group which are reported separately).|||mmHg||Standard Deviation|Mean
2669828|NCT01491919|Secondary|Change in Systolic Blood Pressure From Baseline in Lisinopril-naive Participants|"Ambulatory blood pressure readings were measured during the baseline/pre-study dose period using a SpaceLabs (Redmond, WA) device at home to avoid the confounding effects of venipuncture and abnormal sleep pattern.~Another blood pressure reading was performed at 1 day before the final dose of lisinopril (day before the last scheduled visit).~The mean from these measurements was calculated."|Baseline to Day 14 (+/- 3 days)|Change in systolic blood pressure from baseline is reported here for lisinopril-naive participants (not the standard of care (SOC) group which are reported separately).|||mmHg||Standard Deviation|Mean
2669829|NCT01491919|Secondary|Change in Diastolic Blood Pressure From Baseline in Lisinopril-naive Participants|"Ambulatory blood pressure readings were measured during the baseline/pre-study dose period using a SpaceLabs (Redmond, WA) device at home to avoid the confounding effects of venipuncture and abnormal sleep pattern.~Another blood pressure reading was performed at 1 day before the final dose of lisinopril (day before the last scheduled visit).~The mean of these measurements was calculated."|Baseline to Day 14 (+/-3 days)|Change in diastolic blood pressure from baseline is reported here for lisinopril-naive participants (not the standard of care group which are reported separately).|||mmHg||Standard Deviation|Mean
2669830|NCT01491919|Secondary|Change in Urine Protein/Creatinine From Baseline in Lisinopril-naive Participants.|Change in urine protein/creatinine obtained as follows: Mean change (worst post-dose from baseline) presented for urine protein/creatinine ratio. Geometric mean of the ratio (worst post-dose / baseline with Geometric Coefficient of Variation percent (CV%) and greatest decrease presented for eGFR by dose group. Two patients in the high dose group had an evaluable urine protein/creatinine change.|Baseline to worst post-dose before Day 14 (+/- 3 days)||||mg/mg||Geometric Coefficient of Variation|Geometric Mean
2669831|NCT01491919|Secondary|Largest eGFR Percent Decrease From Baseline in Lisinopril-naive Participants|"The eGFR at entry will need to be ≥ 30 ml/min/1.73m^2 to minimize concerns about an acute angiotensin-converting enzyme inhibitor (ACEI) mediated reduction in kidney function.~Largest eGFR percent decrease from baseline reported in results section."|Baseline to Day 14 (+/- 3 days)||||percentage|||Number
2669832|NCT01491919|Primary|Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) During/After Study Drug Administration|Number of Adverse Events (AEs) related and not related to study drug; number of Serious Adverse Events (SAEs) related and not related to study drug|First dose of study drug to 30 days after final study visit for AEs and until resolution for SAEs||||events|||Number
2669833|NCT01491919|Primary|PK Renal Clearance (CLrenal)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of CLrenal. Geometric mean was calculated from all measurements.|Day 14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose.||||L/h/70 kg||Geometric Coefficient of Variation|Geometric Mean
2669834|NCT01491919|Primary|PK - Oral Clearance (CL/F)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of CL/F. Geometric mean was calculated from all measurements.|Day 14 (+/- 3 d) of dose at 0 hour and at 1, 2, 4, 5, 8, 12, and 24 hrs after dose||||L/h/70 kg||Geometric Coefficient of Variation|Geometric Mean
2669835|NCT01491919|Primary|PK - Time of the Maximum Observed Concentration in Plasma (Tmax)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of plasma lisinopril concentration. Medium was calculated from all measurements.|Day 14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose||||hours||Full Range|Median
2669836|NCT01491919|Secondary|Worse Post-dose Decrease in Estimated Glomerular Filtration Rate (eGFR) From Baseline in Lisinopril-naive Participants|The eGFR at entry will need to be ≥ 30 ml/min/1.73m^2 to minimize concerns about an acute angiotensin-converting enzyme inhibitors (ACE-I)-mediated reduction in kidney function. eGFR ratio was computed from the worst post-dose value divided by the Baseline value.|Baseline to Day 14 (+/- 3 days)||||ratio||Geometric Coefficient of Variation|Geometric Mean
2669837|NCT01491919|Secondary|Change in Potassium Level From Baseline in Lisinopril-naive Participants|Potassium values will be obtained at Baseline and Day 14 prior to the final dose of study drug. Mean calculated from the two measurements.|At baseline visit and Day 14 prior to final study dose.||||mEq/L||Standard Deviation|Mean
2669838|NCT01491919|Primary|PK - Maximum Observed Concentration of Drug in Plasma (Cmax)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of Cmax. Geometric mean was calculated from all measurements.|Day14 (+/- 3 d) of dose at 0 hour and 1, 2, 4, 5, 8, 12, and 24 hrs after dose||||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2669839|NCT01491919|Primary|Pharmacokinetics (PK) - Area Under the Plasma Concentration-time Curve (AUC)|At the Day 14 (±3 days) visit, blood (1 mL) will be collected at 0 hour (pre-dose) and at 1, 2, 4, 5, 8, 12 and 24 hours post-lisinopril dose for determination of AUC. Geometric mean was calculated from all measurements.|Day 14 (+/- 3 days) of lisinopril therapy at hours 0 (pre-dose) and 1,2,4,5,8,12 and 24 hrs after dose||||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2669842|NCT01491893|Primary|Recommended Phase 2 Dose (RP2D)|The RP2D of PVSRIPO is the safe, therapeutic dose where patients have not experienced undue side effects from PVSRIPO or from the management of cerebral inflammation secondary to PVSRIPO administration. 50% Tissue Culture Infective Dose (TCID50) is the unit of measure of infectious virus titer.|5 years||||50% Tissue Culture Infectious Dose|||Number
2669843|NCT01491893|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|The number of dose escalation patients experiencing a dose-limiting toxicity (DLT) will be reported. Any grade 3 or any Grade 4 toxicity that is not reversible within 2 weeks, or any life-threatening event, or treatment-related death will be considered a DLT. Any grade 2 or higher serious autoimmune toxicities particularly those affecting vital organs (e.g. cardiac, renal, CNS) will also be considered a DLT.|28 days after administration of PVSRIPO||||Participants|||Count of Participants
2669844|NCT01491893|Primary|Maximum Tolerated Dose (MTD)|"The MTD will be the highest dose level for which the probability that a dose escalation patient experiences a dose-limiting toxicity (DLT) is estimated to be less than 20%. Any Grade 3 or 4 toxicity that is not reversible within 2 weeks, or any life-threatening event, or treatment-related death will be considered a DLT. Any grade 2 or higher serious autoimmune toxicities particularly those affecting vital organs (e.g. cardiac, renal, CNS) will be considered a DLT. 50% Tissue Culture Infective Dose (TCID50) is the unit of measure of infectious virus titer.~The MTD was determined based on the first 9 patients treated with PVSRIPO- 1 at dose level 1 (1.0 x 10e8 TCID50 (50% Tissue Culture Infectious Dose)), 1 at dose level 2 (3.3 x 10e8 TCID50), 1 at dose level 3 (1.0 x 10e9 TCID50), 2 at dose level 4 (3.3 x 10e9 TCID50), and 4 at dose level 5 (1.0 x 10e10 TCID50)."|28 days after administration of PVSRIPO|All participants who received a dose of PVSRIPO at any dose level|||50% Tissue Culture Infectious Dose|||Number
2669845|NCT01491854|Primary|To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through HOMA and QUICKI Scores|"Supportive to Primary Endpoint. HOMA = homeostasis model assessment for Insulin resistance: Healthy Range: 1.0 (0.5-1.4).~< 1.0 means you are insulin-sensitive which is optimal. >1.9 indicates early insulin resistance. > 2.9 indicates significant insulin resistance. The quantitative insulin sensitivity check index (QUICKI) measures insulin sensitivity, which is the inverse of insulin resistance. The QUICKI calculation for insulin resistance in humans fall broadly within a range between 0.45 for unusually healthy individuals and 0.30 in diabetics. Lower numbers reflect greater insulin resistance."|baseline, 6 months, 1 year, 5 years|safety Analysis set with measure|||score on a scale||Standard Deviation|Mean
2669846|NCT01491854|Secondary|to Evaluate Final Height||baseline, 6 months, 1 year, 5 years|Full Analysis set with measure|||cm||Standard Deviation|Mean
2669847|NCT01491854|Primary|To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Glucose Glycolsylated Hemoglobin (HbA1c)|Supportive to Primary Endpoint|baseline, 6 months, 1 year, 5 years|full Analysis set with measure|||percentage||Standard Deviation|Mean
2669848|NCT01491854|Primary|To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Insulin Levels|Supportive to Primary Endpoint|baseline, 6 months, 1 year, 5 years|full Analysis set with measure|||pmol/L||Standard Deviation|Mean
2669849|NCT01491854|Primary|To Evaluate the Long Term Effects of rhGH on Carbohydrate Metabolism Through Fasting Plasma Glucose (FPG) Levels|Supportive to Primary Endpoint|baseline, 6 months, 1 year, 5 years|safety Analysis set with measure|||mmol/L||Standard Deviation|Mean
2669850|NCT01491854|Secondary|To Evaluate the Incidence of Anti-rhGH Antibodies After Termination of Growth Hormone Treatment.|number of participants with positive results for anti-drug antibody (ADA). Percentages indicated are calculated based on the total number of patients (118 participants).|baseline, 6 months, 1 year, 5 years|safety Analysis set|||Participants|||Count of Participants
2669851|NCT01491854|Secondary|to Evaluate IGF-I and IGFBP-3 Levels After End of Growth Hormone Treatment||baseline, 6 months, 1 year , 5 years|full Analysis set, with measure|||nmol/L||Standard Deviation|Mean
2669852|NCT01491854|Primary|Evaluate the Long-term Effect of Growth Hormone Treatment on the Development of Diabetes After End of Therapy.|"Number of participants diagnosed with Diabetes mellitus type 2 during the study, defined as fullfilment of these 3 criteria:~FPG ≥ 126 mg/dl (7.0 mmol/L) during blood sampling and/or during Oral Glucose Tolerance Test (OGTT)~2-h plasma glucose ≥ 200 mg/dl (11.1 mmol/L) during an OGTT~Investigator documenting diagnosis of diabetes mellitus type 2 during OGTT"|5 years|full Analysis set|||Participants|||Count of Participants
2669853|NCT01491841|Secondary|Overall Survival||from day 1 of treatment to death|Groups combined to include all subjects who completed the study. This analysis was originally planned for Phase 2; there was no intent to compare dose levels in Phase 1 because there would be insufficient power to make meaningful comparisons.|||months||95% Confidence Interval|Median
2669854|NCT01491841|Secondary|Toxicity|Dose limiting toxicities plus % of patients with a clinically significant change in left ventricular ejection fraction.|30 days post last dose of study drug|Phase 1 subjects who received study drugs.|||Participants|||Count of Participants
2669855|NCT01491841|Secondary|Progression Free Survival||From day 1 of treatment to disease progression, death or 5 years, whichever comes first|Groups combined to include all subjects who completed the study. This analysis was originally planned for Phase 2; there was no intent to compare dose levels in Phase 1 because there would be insufficient power to make meaningful comparisons.|||months||95% Confidence Interval|Median
2669856|NCT01491841|Secondary|Overall Response|"Partial response and complete response evaluated using a modified version of the revised response criteria for malignant lymphoma by Cheson et al~Complete Response (CR) • Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present prior to therapy.~Complete Response Unconfirmed (CRu) meets the CR criteria, but with one or more of the following:~A residual node > 1.5 cm in greatest transverse diameter that has regressed >75% in the sum of the product of the diameters (SPD). Individual nodes that were previously confluent must have regressed >75% in their SPD compared with the size of the original mass.~Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia by immunohistochemistry or flow cytometry).~Partial Response (PR)~• A decrease of ≥ 50% in the SPD of up to six of the largest dominant nodes or nodal masses."|up to 220 days|Subjects who received at least 2 cycles of study drug were included. Data from the single patient enrolled in the phase 2 portion of the trial was included with the phase I pixantrone 115mg/m2 group because the phase 2 patient also received the 115mg/m2 dose and the combined data seems more meaningful than presenting data for 1 patient separately.|||Participants|||Count of Participants
2669857|NCT01491841|Primary|Maximum Tolerated Dose|Dose-limiting toxicity (DLT) assessments were performed weekly during cycles 1 and 2. A DLT was defined as any grade 3 non-hematologic toxicity that lasted longer than 48 hours, despite proper supportive care, any grade 4 non-hematologic toxicity, or any grade 3 or 4 hematologic toxicity lasting longer than 7 days. Alopecia and febrile neutropenia were not considered DLTs. Any NCI CTC (National Cancer Institute Common Terminology Criteria) v4.03 grade 5 (death) toxicity was considered a DLT. Dose Limiting Toxicities were used as the assessment criteria to determine the Maximum Tolerated Dose (MTD). MTD is presented.|4 years|Over the course of 4 years, dose escalation was performed in 3 cohorts. Cohort 1 (Phase 1: Pixantrone, 55mg/m^2) enrolled 7 people; Cohort 2 (Phase 1: Pixantrone, 85mg/m^2) enrolled 7 people; Cohort 3 (Phase 1: Pixantrone, 115 mg/m^2) enrolled 7 people.|||milligrams per meter squared|||Number
2669858|NCT01491802|Secondary|Forced Expiratory Volume in 1 Second (FEV1)|Measurements of pulmonary function included spirometry and body plethysmography. Values reported are 90 minutes post-dose after 4 weeks of treatment.|4 weeks|14 subjects completed both treatments for comparison.|||L||Standard Deviation|Mean
2669859|NCT01491802|Secondary|Mean Expiratory Flow at Isotime Exercise|Mean expiratory flow was measured during constant work rate exercise tests. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.|4 weeks|14 subjects completed both treatment arms for comparison.|||L/s||Standard Deviation|Mean
2669860|NCT01491802|Secondary|Tidal Esophageal Pressure (Pes) Swings at Isotime Exercise|Tidal esophageal pressure (Pes) swings were measured via an esophageal balloon catheter during constant work rate exercise tests. Tidal Pes expressed relative to maximum is an index of respiratory effort. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.|4 weeks|Although 14 subjects completed both treatment arms for comparison, only 9 subjects also had complete measurements of EMGdi and respiratory pressures.|||percentage of maximum Pes||Standard Deviation|Mean
2669861|NCT01491802|Secondary|Diaphragm Electromyogram (EMGdi) at Isotime Exercise|EMGdi was measured during constant work rate exercise tests via a multipair-electrode esophageal catheter. EMGdi expressed as a percentage of its maximum is used as an index of inspiratory neural drive. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.|4 weeks|Although 14 subjects completed both treatment arms, only 9 subjects had complete measurements of EMGdi and respiratory pressures.|||percentage of maximum EMGdi||Standard Deviation|Mean
2669862|NCT01491802|Secondary|Inspiratory Capacity at Isotime Exercise|Measurements of inspiratory capacity (IC) were conducted during constant work rate exercise tests. Isotime was defined as the highest time in minutes completed in both post-treatment tests.|4 weeks|14 subjects completed both treatment arms for comparison.|||L||Standard Deviation|Mean
2669863|NCT01491802|Secondary|"Intensity of Unpleasantness of Breathing at Isotime Exercise"|"Intensity rating (modified 10-point Borg scale) measured at a standardized time (isotime) during constant work rate exercise tests. A rating of 0 represents no unpleasantness of breathing up to a maximum of 10. An improvement would be noted as a decrease in the Borg scale rating. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests."|4 weeks|Of the 17 randomized subjects, 3 subjects were withdrawn (2 AEs, 1 withdrawn consent ) leaving 14 completed subjects for analysis.|||units on a scale||Standard Deviation|Mean
2669864|NCT01491802|Secondary|Ventilation at Isotime Exercise|Ventilation was measured during constant work rate exercise tests. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.|4 weeks|14 subjects completed both treatment arms for comparison.|||L/min||Standard Deviation|Mean
2669865|NCT01491802|Secondary|Inspiratory Capacity at Rest|Measurements of pulmonary function included spirometry and body plethysmography. The resting inspiratory capacity (IC) values reported here are 90 minutes post-dose after 4 weeks of treatment.|4 weeks|14 subjects completed both treatments for comparison.|||L||Standard Deviation|Mean
2669866|NCT01491802|Secondary|Exercise Endurance Time|Duration of constant work rate cycle exercise at 75% of maximum|4 weeks||||minutes||Standard Deviation|Mean
2669867|NCT01491802|Primary|Exertional Dyspnea Intensity at Isotime Exercise.|Intensity of dyspnea (defined as breathing discomfort) at a standardized time (isotime) during constant work rate exercise tests as measured by the modified 10-point Borg scale. A rating of 0 represents no dyspnea up to a maximum of 10: a smaller rating is therefore an improvement. Isotime was defined as the highest exercise time in minutes completed in both post-treatment tests.|4 weeks|Of the 17 randomized subjects, 3 subjects were withdrawn (2 AEs, 1 withdrawn consent ) leaving 14 completed subjects for analysis.|||units on a scale||Standard Deviation|Mean
2669868|NCT01491737|Secondary|Percentage of Participants With Any Adverse Event (AE)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.|Up to 49 months approximately|Safety population included all participants who had received at least 1 dose of any study medication assigned to treatment arms as treated.|||percentage of participants|||Number
2669869|NCT01491737|Secondary|Change From Baseline in Health-Related Quality of Life as Determined by European Quality of Life 5-Dimension (EQ-5D) Visual Analog Scale (VAS) Scores|EQ-5D VAS: participant rated questionnaire to assess health-related quality of life (QoL) in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, every 3 cycles (21-day cycle), and every 3 months after treatment discontinuation (up to 49 months, approximately)|ITT population included all randomized participants. Here, ‘n’ number of participants who were evaluated at specified time point.|||unit on a scale||Standard Deviation|Mean
2669880|NCT01491672|Secondary|Duration of PFS for Each First-line Treatment Cohort|Duration of PFS during second-line treatment was defined as the time from the date of enrollment to the date of the first documented disease progression or death due to any cause. Participants' assessment was based on the local radiological data according to the RECIST 1.0 Criteria.|20 months|The FAS was used. It included all enrolled participants.|||months||95% Confidence Interval|Median
2671526|NCT01475513|Secondary|Change From Baseline in Disposition Index at 6 Months|Modeled from FISVGTT--higher values indicate better glucose disposition|Baseline, 6 months||||AIRG * Si||95% Confidence Interval|Mean
2669870|NCT01491737|Secondary|Clinical Benefit Response (CBR)|CBR is percentage of participants with best (confirmed) PR or CR or SD for at least 6 months. According to RECIST version 1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Baseline up to 49 months, approximately|ITT population included all randomized participants. Here, number of participants analyzed is the participants with measurable disease at baseline.|||percentage of participants||95% Confidence Interval|Number
2669871|NCT01491737|Secondary|Objective Overall Response Rate (ORR)|ORR was defined as participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference baseline sum diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Participants needed to have two consecutive assessments of PR or CR to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable.|Baseline up to 49 months, approximately|ITT population included all randomized participants. Here, number of participants analyzed are the participants who had measureable disease at baseline.|||percentage of participants||95% Confidence Interval|Number
2669872|NCT01491737|Secondary|Time to Response (TTR)|TTR was defined as the time from the date of randomization to the date of first CR or PR. According to RECIST version 1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. A censored time to response was calculated at the date of the last adequate tumor assessment as there was no date of confirmed response (CR or PR). If no tumor assessment is performed for the participant (or all post-baseline assessments are not evaluable or PD) the censoring day would be set to day 1 (date of randomization).|Baseline up to 49 months, approximately|ITT population included all randomized participants. Here, number of participants analyzed are the participants who were responders and had measurable disease at baseline.|||months||95% Confidence Interval|Median
2669873|NCT01491737|Secondary|Duration of Response (DOR)|DOR was defined as the period from the date of initial confirmed partial response (PR) or complete response (CR) until the date of progressive disease or death from any cause. According to RECIST version 1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants with no documented progression after CR or PR were censored at the last date at which they were known to have had the CR or PR, respectively.|Baseline up to 49 months, approximately|ITT population included all randomized participants. Here, number of participants analyzed are the participants who were responders and had measurable disease at baseline.|||months||95% Confidence Interval|Median
2669874|NCT01491737|Secondary|Overall Survival (OS)|OS is defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication (pertuzumab, trastuzumab, AI or induction chemotherapy), and participants with no post-baseline information were censored at the date of randomization.|From the date of randomization until first documented death (approximately, up to 49 months)|ITT population included all randomized participants.|||Months||95% Confidence Interval|Median
2669875|NCT01491737|Primary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization until the first radiographically documented progression of disease or death from any cause, whichever occurred first (either during study treatment or during follow-up). Progression of disease was evaluated according to the response evaluation criteria in solid tumors (RECIST) (version 1.1). Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progression). Participants with no PFS events were censored at the time of the last evaluable tumor assessment.|Baseline to progressive disease or death (approximately, up to 49 months)|Intent-to-Treat (ITT) population included all randomized participants.|||months||95% Confidence Interval|Median
2669876|NCT01491672|Secondary|Duration of Response (DoR)|DoR was defined as the time from the first occurrence of PR or CR (as per local radiological review) until the date of the first documented disease progression or death due to underlying cancer.|20 months|The FAS was considered for this analysis. The FAS included all enrolled participants. Only participants who achieved a CR or PR were analyzed. Therefore, actual n=4,3,3,10.|||months||95% Confidence Interval|Median
2669877|NCT01491672|Secondary|Objective Response Rate (ORR)|ORR was defined as the proportion of participants with best overall response of CR or PR based on the local radiological data according to the RECIST 1.0 Criteria|20 months|The FAS was used. It included all enrolled participants.|||Participants|||Number
2669878|NCT01491672|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) or stable disease based on the local radiological data according to the RECIST 1.0 criteria.|20 months|The FAS was used. It included all enrolled participants.|||Participants|||Number
2669879|NCT01491672|Secondary|Overall Survival (OS)|OS was defined as the time from date of enrollment to date of death due to any cause.|28 months|The FAS was used. It included all enrolled participants.|||months||95% Confidence Interval|Median
2669926|NCT01491035|Primary|Oral Clearance (CL/F) of Vortioxetine|Oral clearance expressed as a function of bioavailability|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set|||L/h||Standard Deviation|Median
2669881|NCT01491672|Primary|Progression-free Survival (PFS) - All Participants|PFS during second-line treatment was defined as the time from the date of enrollment to the date of the first documented disease progression or death due to any cause. The primary analysis of PFS was based on a local radiology review of CT scans and MRI collected until the participant experienced disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0.|20 months|The full analysis set (FAS) was used. It included all enrolled participants.|||months||95% Confidence Interval|Median
2669882|NCT01491633|Post-Hoc|Time on Study|Number of days participant remained on study|2 years||||days||Standard Deviation|Mean
2669883|NCT01491633|Secondary|Toxicities|Define the toxicities of dasatinib when administered to the patient population. NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 will be utilized for adverse event reporting.|2 years||||grade 3 toxicities|||Number
2669884|NCT01491633|Secondary|Survival|Establish the overall survival of patients with SCC treated with dasatinib|2 years|One subject who was alive at the end of the study was censored from the survival analysis|||days||Standard Deviation|Mean
2669885|NCT01491633|Secondary|Types and Frequency of DDR2 Mutations|Determine frequency of DDR2 mutations in study patients|2 years||||participants|||Number
2669886|NCT01491633|Primary|Response Rate|Determine the overall response rate of patients with squamous cell carcinoma of the lung treated with dasatinib|2 years||||percent|||Number
2669887|NCT01491607|Secondary|Percentage of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards|Systemic reactions (fatigue/ tiredness, muscle ache, headache, and fever) were evaluated by using a web-enabled subject diary. Subjects assessed severity as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of fever was assessed using a grading scale. Severe systemic reactions were to be recorded as adverse events by the investigator site staff after confirmation with the subject.|Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).|The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).|||percentage of participants|||Number
2669888|NCT01491607|Secondary|Incidence of Systemic Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards|Systemic reactions (fatigue/ tiredness, muscle ache, headache, and fever) were evaluated by using a web-enabled subject diary. Subjects assessed severity as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of fever was assessed using a grading scale. Severe systemic reactions were to be recorded as adverse events by the investigator site staff after confirmation with the subject.|Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).|The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).|||participants|||Number
2669889|NCT01491607|Secondary|Percentage of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards|Injection site reactions (warmth, tenderness, itching, pain, arm motion limitation, redness, lump, swelling, and bruise) were evaluated by using a web-enabled subject diary. Subjects assessed the severity of warmth, tenderness, itching, pain, arm motion limitation, lump, and bruise as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of redness and swelling were based on the diameter of the affected area. Severe injection site reactions were recorded as adverse events by the investigator site staff after confirmation with the subject.|Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).|The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).|||percentage of participants|||Number
2669890|NCT01491607|Secondary|Incidence of Injection Site Reactions by Severity (Mild, Moderate, Severe) From Subject Diary Cards|Injection site reactions (warmth, tenderness, itching, pain, arm motion limitation, redness, lump, swelling, and bruise) were evaluated by using a web-enabled subject diary. Subjects assessed the severity of warmth, tenderness, itching, pain, arm motion limitation, lump, and bruise as absent, mild, moderate, or severe based on the degree of interference with daily activities. Severity of redness and swelling were based on the diameter of the affected area. Severe injection site reactions were recorded as adverse events by the investigator site staff after confirmation with the subject.|Web-enabled diaries were completed for 7 days after each of three injections (Days 0, 14, and 28).|The reporting group was subjects who had any diary data available during the 7-day-post-vaccination period (i.e., n=196, n=196, and n=193, for the1st, 2nd, and 3rd post-vaccination periods, respectively).|||participants|||Number
2669891|NCT01491607|Secondary|Average Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value Between Days 63 and 100 (Inclusive).|Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.|Days 63 to 100|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive.|||percentage of participants||95% Confidence Interval|Mean
2669892|NCT01491607|Secondary|Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 70.|Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.|Day 70 +/- 2 days|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days.|||percentage of participants||95% Confidence Interval|Least Squares Mean
2669927|NCT01491035|Primary|t½ of Lu AA34443|Half-life of the major, inactive metabolite Lu AA34443 in plasma|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set|||h||Standard Deviation|Median
2669893|NCT01491607|Primary|Percentage of Subjects Achieving a TNA Response of a Predefined Threshold Value at Day 63 (5 Weeks Following the Third Vaccination on Day 28).|Neutralizing antibody levels in blinded serum samples were measured using a validated anthrax lethal toxin neutralization assay. The primary assay endpoint was the 50% neutralization factor (TNA NF50), which is calculated as the ratio of the 50% effective dose (ED50) of the test sample to the ED50 of a reference serum.|Day 63 +/- 2 days|Subjects who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.|||percentage of participants||95% Confidence Interval|Mean
2669894|NCT01491490|Primary|Change in Bodyweight.|Efficacy of a 40:1 ratio of GWP42003:GWP42004 compared with placebo in the change from baseline in body weight after 42 days (6 weeks) in subjects currently being treated with olanzapine for schizophrenia or other non-affective psychosis.|6 weeks from Baseline.||||Kg|||Number
2669895|NCT01491178|Secondary|Incidences of Stroke and Systemic Embolism (SEE)|Incidence rate of Stroke and SEE (number of patients per 100 patient year) with 95% confidence interval (CI) is reported. Stroke and SEE were recorded as adverse events (AEs) of special interest. Exact Poisson confidence intervals are presented for incidence rate.|Up to 104 weeks from first administration of study drug|Effectiveness set: This analysis set included all patients who received treatment of Prazaxa® Capsules except those who were found not following registration rule, no actual visit, previous treatment experience with Prazaxa, contraindication and / or who did not suffer from NVAF.|||Number of patients per 100 patient year||95% Confidence Interval|Number
2669896|NCT01491178|Primary|Frequency (Percentage) of Participants With Adverse Drug Reactions|"Percentage of participants with adverse drug reactions (ADRs) is presented. An ADR is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Prazaxa® Capsules either as Related, Probably related, or Cannot be denied."|Up to 104 weeks from first administration of study drug|Safety set: This patient set includes all patients who received treatment of Prazaxa® Capsules except those who were found not following registration rule, no actual visit, previous treatment experience with Prazaxa.|||Percentage of participants|||Number
2669897|NCT01491113|Secondary|Hemodialysis Clearance (CLHD) of Ucb L059 (LEV) During First Dialysis for Group E|Calculated according: CLHD=CLD+CLUF.|From 44 hours to 48 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2669898|NCT01491113|Secondary|Ultrafiltration Clearance (CLUF) of Ucb L059 (LEV) During First Dialysis for Group E|Calculated by the Arterio - Venous difference method and cumulative dialysate method.|From 44 hours to 48 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2669899|NCT01491113|Secondary|Hemodialysis Clearance (CLD) of Ucb L059 (LEV) During First Dialysis for Group E|Calculated by the Arterio - Venous difference method and cumulative dialysate method.|From 44 hours to 48 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2669900|NCT01491113|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Group E During First Period|tmax refers to the time to reach maximum plasma concentration (tmax).|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||hours||Full Range|Median
2669901|NCT01491113|Secondary|Terminal Half-life (t1/2) of Ucb L059 (LEV) for Group E During First Period|"Terminal half-life refers to the time it takes for the concentrations to decrease by half.~Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %."|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||hours||Full Range|Median
2669902|NCT01491113|Secondary|Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Group E|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %."|From Baseline to 140 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||h*µg/mL||Full Range|Median
2669903|NCT01491113|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (Levetiracetam) for Group E During First Period|tmax refers to the time to reach the maximum plasma concentration of ucb L059 (Levetiracetam).|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||hours||Full Range|Median
2669904|NCT01491113|Secondary|Terminal Half-life (t1/2) of Ucb L057 for Groups A to D|"Terminal half-life refers to the time it takes for the concentrations to decrease by half.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||hours||Full Range|Median
2669905|NCT01491113|Secondary|Area Under the Concentration-time Curve (AUC) of Ucb L057 From Baseline to Infinite for Groups A to D|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||h*µg/mL||Full Range|Median
2669906|NCT01491113|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Groups A to D|"tmax refers to the time to reach maximum plasma concentration (tmax).~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||hours||Full Range|Median
2669907|NCT01491113|Secondary|Terminal Half-life (t1/2) of Ucb L059 (LEV) for Groups A to D|"Terminal half-life refers to the time it takes for the concentrations to decrease by half.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||hours||Geometric Coefficient of Variation|Geometric Mean
2669908|NCT01491113|Secondary|Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Groups A to D|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2669909|NCT01491113|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (LEV) for Groups A to D|"tmax refers to the time to reach maximum plasma concentration of ucb L059 (Levetiracetam).~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||hours||Full Range|Median
2669910|NCT01491113|Secondary|Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Group E During First Period|"Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It indicates the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time period.~Geometric mean and Coefficient of Variation (CV) was not calculated since the extrapolated part of the AUC was greater than 20 %."|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||L/h||Full Range|Median
2669911|NCT01491113|Secondary|Renal Clearance (CLR) of Ucb L057 for Groups A to D|"Renal clearance describes the removal of drug from a volume of plasma in a given unit of time by the kidneys.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2669912|NCT01491113|Secondary|Total Amount Excreted in Urine (Ae) of Ucb L057 for Groups A to D|"Ae refers to the total amount of ucb L057 excreted in urine.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||mg||Geometric Coefficient of Variation|Geometric Mean
2669913|NCT01491113|Secondary|Nonrenal Clearance (CLNR) of Ucb L059 (LEV) for Groups A to D|"The Non-Renal Clearance (CLNR) describes the removal of drug by organs other than the kidneys.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2669914|NCT01491113|Secondary|Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Groups A to D|"Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It indicates the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time period.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2671527|NCT01475513|Secondary|Change From Baseline in Glucose Effectiveness|Obtained from FSIVGTT models--higher values indicate better effectiveness of glucose inducing its own disposition|Baseline, 6 months||||1000 * min ^ -1||95% Confidence Interval|Mean
2669915|NCT01491113|Secondary|Renal Clearance (CLR) of Ucb L059 (LEV) for Groups A to D|"Renal clearance describes the removal of drug from a volume of plasma in a given unit of time by the kidneys.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2669916|NCT01491113|Secondary|Fraction of Dose Excreted in Urine (fe) of Ucb L059 (LEV) for Groups A to D|"fe refers to the fraction of dose excreted in urine of L059 (Levetiracetam).~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||Percentage of Dose Administered||Geometric Coefficient of Variation|Geometric Mean
2669917|NCT01491113|Secondary|Total Amount Excreted in Urine (Ae) of Ucb L059 (LEV) for Groups A to D|"Ae refers to the total amount of ucb L059 (Levetiracetam) excreted in urine.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||mg||Geometric Coefficient of Variation|Geometric Mean
2669918|NCT01491113|Primary|Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to 44 Hours for Group E|AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2669919|NCT01491113|Primary|Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Group E During First Period|Cmax refers to the maximum observed concentration of ucb L057.|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2669920|NCT01491113|Primary|Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to 44 Hours for Group E|AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2669921|NCT01491113|Primary|Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Group E During First Period|Cmax refers to the maximum observed concentration of ucb L059 (Levetiracetam).|From Baseline to 44 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2669922|NCT01491113|Primary|Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to the Last Quantifiable Concentration for Groups A to D|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2669923|NCT01491113|Primary|Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Groups A to D|"Cmax refers to the maximum observed concentration of ucb L057.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2669924|NCT01491113|Primary|Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to the Last Quantifiable Concentration for Groups A to D|"AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||h*µg/mL||Geometric Coefficient of Variation|Geometric Mean
2669925|NCT01491113|Primary|Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Groups A to D|"Cmax refers to the maximum observed concentration of L059 (Levetiracetam).~Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours"|From Baseline up to 144 hours post first dose|The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2669928|NCT01491035|Primary|AUC(0-24h) of Lu AA34443|Area under the plasma concentration-time curve from 0 to 24 hours for the major, inactive metabolite Lu AA34443|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set|||ng*h/mL||Standard Deviation|Median
2669929|NCT01491035|Primary|Cmax of Lu AA34443|Maximum plasma concentration of the major, inactive metabolite Lu AA34443|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose level|Pharmacokinetic analysis set|||ng/mL||Standard Deviation|Median
2669930|NCT01491035|Primary|t½ of Vortioxetine|Half-life of vortioxetine in plasma|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set|||h||Standard Deviation|Median
2669931|NCT01491035|Primary|AUC(0-24h) of Vortioxetine|Area under the vortioxetine plasma concentration-time curve from 0 to 24 hours|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18 or 20, depending on assigned dose level|Pharmacokinetic analysis set|||ng*h/mL||Standard Deviation|Median
2669932|NCT01491035|Primary|Cmax of Vortioxetine|Maximum plasma concentration of vortioxetine|Pre-dose and 1, 3, 5, 8, 12 and 24 hours post-dose on Day 14, 16, 18, or 20, depending on assigned dose level|Pharmacokinetic analysis set = all patients who took at least one dose of IMP and who contributed with both Day 1 pre-dose pharmacokinetic sampling data and sufficient post-dose sampling data for estimation of the pharmacokinetic parameters.|||ng/mL||Standard Deviation|Median
2669933|NCT01491022|Secondary|Change in Stride Legth|change in stride length as measured by 3 D capture analysis|4 weeks||||meters||Standard Deviation|Mean
2669934|NCT01491022|Secondary|Timed 25-foot Walk Test (T25FW)|time required to perform T25FW.|4 weeks||||seconds||Standard Error|Mean
2669935|NCT01491022|Secondary|Timed Up and Go (TUG) Score|time required to perform TUG.|4 weeks||||seconds||Standard Error|Mean
2669936|NCT01491022|Secondary|Freezing of Gait Questionnaire (FOGQ)|change in FOGQ score 0- 16, where 0 is normal, 16 is severely impaired|4 weeks||||units on a scale||Standard Deviation|Mean
2669937|NCT01491022|Secondary|United Parkinson's Disease Rating Scale Score(UPDRS) ,|change in UPDRS score (motor) range 0-104, where 0 is good and 104 is worse.|4 weeks||||units on a scale||Standard Error|Mean
2669938|NCT01491022|Primary|Change in Velocity|The primary outcome measure will be the change in gait velocity as measured with by 3-dimensional gait analysis system.|baseline and 4 weeks||||m/s||Standard Deviation|Mean
2669939|NCT01490931|Primary|Comparison of Pain Intensity Scores at 6 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||6 Hours post-dose||||millimeters||Standard Error|Mean
2669940|NCT01490931|Primary|Comparison of Pain Intensity Scores at 5 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||5 Hours post-dose||||millimeters||Standard Error|Mean
2669941|NCT01490931|Primary|Comparison of Pain Intensity Scores at 4 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||4 Hours post-dose||||millimeters||Standard Error|Mean
2669942|NCT01490931|Primary|Comparison of Pain Intensity Scores at 3 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||3 hours post-dose||||millimeters||Standard Error|Mean
2669943|NCT01490931|Primary|Comparison of Pain Intensity Scores at 2 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||2 Hours||||millimeters||Standard Error|Mean
2669944|NCT01490931|Primary|Comparison of Pain Intensity Scores at 90 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period||90 minutes post-dose||||millimeters||Standard Error|Mean
2669945|NCT01490931|Primary|Comparison of Pain Intensity Scores at 60 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period|VAS pain intensity score 60 minutes after dosing.|60 minutes post dose||||millimeters||Standard Error|Mean
2669946|NCT01490931|Primary|Comparison of Pain Intensity Scores at 40 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period.|VAS pain intensity score at 40 minutes post-dose|40 minutes post dose||||millimeters||Standard Error|Mean
2669947|NCT01490931|Secondary|Median Onset of Meaningful Pain Relief|Measure obtained using recognized double-stop watch technique. Patient is asked to depress the second stop watch when pain relief is meaningful to them. Each patient decides what meaningful relief is for them.|At time of depressing meaningful relief stopwatch up to 6 hours.||||seconds||95% Confidence Interval|Median
2669948|NCT01490931|Secondary|Most Frequent Number of Days of Analgesic Dosing in Dental Implant Surgery Patients When Employing Intranasal Ketorolac as Their Pain Medication.|Self explanatory|Up to 5 days||||days|||Number
2669949|NCT01490931|Secondary|Percentage of Subjects Who Reach a Level of at Least Moderate Pain by Achieving a Score of at Least 40 mm on a 100 mm Visual Analog Scale Within 5 Hours After the Completion of Surgery.||Up to 5 hours after last suture is placed|All subjects (regardless of pain intensity) receiving one to three dental implants|||percentage of participants|||Number
2669950|NCT01490931|Primary|Comparison of Pain Intensity Scores at 20 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period.|Pain intensity scores will be recorded by patient employing a standard 100 mm visual analog scale|20 minutes post dose||||millimeters||Standard Error|Mean
2669951|NCT01490931|Secondary|The Median Onset of First Perceptible Pain Relief of Intranasal Ketorolac in Dental Implant Surgery Patients|Data will be obtained employing the well-described double stop watch technique|Censored at 6 hours||||seconds||95% Confidence Interval|Median
2669952|NCT01490892|Secondary|Change in Vascular Volume of Breast Lesions as Assessed by Subharmonic Imaging (SHI) Signal Intensity|Quantitative measures of the vascular volumes of breast lesions determined by SHI utilizing bifurcations and vessel length, and blood pool and parametric imaging|2 hours|breast cancer lesions|||dB||Standard Deviation|Mean
2669953|NCT01490892|Primary|Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI)|Characterization of benign and malignant breast cancer lesions is compared by each imaging method which evaluates vascular activity. Imaging methods to be compared are 3D Subharmonic imaging (SHI) or pulse inversion harmonic imaging (HI), fundamental grayscale ultrasound (US) or power Doppler imaging (PDI). Data will be analyzed qualitatively.|2 hours||||lesions|||Number
2669954|NCT01490866|Secondary|Frequency of Adverse Events as a Measure of Safety|The frequency of adverse events (AEs) was analyzed in 2 groups of patients, those receiving FOLFOX/bevacizumab (N=70), and patients who received axitinib maintenance (N = 48). AEs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.|Every 4 weeks plus 30 days during treatment and up to 5 years thereafter.||||participants|||Number
2669955|NCT01490866|Secondary|Overall Survival (OS)|Defined as the time from first treatment until death from any cause.|every 8 weeks until progression then every 3 months for up to 5 years.||||months||95% Confidence Interval|Median
2669956|NCT01490866|Secondary|Time To Progression (TTP)|Defined as the time after a disease is diagnosed (or treated) until worsening of the disease.|every 8 weeks, assessed approximately up to 24 months||||months||95% Confidence Interval|Median
2669957|NCT01490866|Secondary|Objective Response Rate|Defined as the percentage of evaluable patients showing a complete or partial response (CR or PR) per RECIST v1.1 criteria. CR = disappearance of all lesions. PR = at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest (nadir) sum LD since start of treatment.|every 8 weeks, assessed up to approximately 24 months||||percentage of participants|||Number
2669958|NCT01490866|Primary|Progression-free Survival|Defined as the time from first treatment until objective tumor progression or death from any cause, assessed according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.|24 months|All patients who received at least one dose of any study drug.|||months||95% Confidence Interval|Median
2669959|NCT01490840|Secondary|Change From Baseline in Peak Expiratory Flow as Measured by a Physical Endurance Spiroergometry on a Treadmill|Physical endurance spiroergometry was accomplished. Ergometry was assessed according to national guidelines of the German society for sports medicine. Ergometry is a combined examination of circulation and lung function and was performed as a submaximal or maximal test depending on the participant's individual performance. A positive change from baseline indicates improvement.|Baseline, 6 months|The ModFAS, which included participants with sufficient e-training compliance, was considered for the analysis. Only participants with both baseline and month 6 values were analyzed.|||L/s||95% Confidence Interval|Least Squares Mean
2669960|NCT01490840|Secondary|Change From Baseline in Aerobic Capacity (VO2max) as Measured by a Physical Endurance Spiroergometry on a Treadmill|Physical endurance spiroergometry was accomplished. Ergometry was assessed according to national guidelines of the German society for sports medicine. Ergometry is a combined examination of circulation and lung function and was performed as a submaximal or maximal test depending on the participant's individual performance. A negative change from baseline indicates improvement.|Baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.|||[ml/min/kg][watt/kg body weight]||95% Confidence Interval|Least Squares Mean
2669961|NCT01490840|Secondary|Change From Baseline in Depression as Measured by the Beck Depression Inventory Second Edition (BDI-II)|The Beck Depression Inventory Second Edition (BDI-II) is a 21-item self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders Fourth Edition. Each of the 21 items corresponding to a symptom of depression is summed to give a single score for the BDI-II. There is a four-point scale for each item ranging from 0 to 3. The total score ranges from 0 - 63. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. A negative change from baseline indicates improvement.|Baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.|||score on a scale||95% Confidence Interval|Least Squares Mean
2669962|NCT01490840|Secondary|Change From Baseline in Fatigue as Measured by the WEIMuS (Würzburg Fatigue Inventory for MS)|The WEIMuS (Würzburg Fatigue Inventory for MS) scale is a validated self-assessment instrument to quantify the degree of fatigue. The scale consists of 17 items with 5 categories that are scored from '0' to '4'. The subscores for cognitive and physical fatigue range from 0 to 36 and from 0 to 32, respectively, with the total sum score ranging from 0 to 68; higher scores indicate higher degrees of fatigue. A negative change from baseline indicates improvement.|Baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.|||score on a scale||95% Confidence Interval|Least Squares Mean
2669963|NCT01490840|Secondary|Change From Baseline in Quality of Life as Measured by the Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS)|The Hamburg Quality of Life Questionnaire in Multiple Sclerosis (HAQUAMS) consists of 44 items, 28 of which are the basis for computation of five subscale scores reflecting major dimensions of health-related quality of life (HRQoL) in MS: Fatigue/Thinking (4 items), Mobility lower limb (5 items), Mobility upper limb (5 items), Social function (6 items) and Mood (eight items). Subscales and total score range from 1 to 5, with high scores indicating a lower quality of life. In this study, the total score and following 3 subscales: fatigue/thinking, mobility lower limb and mobility upper limb only were analyzed. A negative change from baseline indicates improvement.|Baseline, 6 months, 12 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.|||score on a scale||95% Confidence Interval|Least Squares Mean
2669964|NCT01490840|Secondary|Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Leg Strength Endurance|"Isometric and dynamic muscular strength was measured by an Isomed 2000 isometric measurement device (knee flexion/tension, trunk flexion/extension).~Isomed 2000 device measures muscular flexion and tension under standardized training conditions. A positive change from baseline indicates improvement."|baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.|||joule||95% Confidence Interval|Least Squares Mean
2669965|NCT01490840|Secondary|Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Change in Leg Strength and Trunk Strength|"Isometric and dynamic muscular strength was measured by an Isomed 2000 isometric measurement device (knee flexion/tension, trunk flexion/extension).~Isomed 2000 device measures muscular flexion and tension under standardized training conditions. A positive change from baseline indicates improvement."|baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.|||newton meter||95% Confidence Interval|Least Squares Mean
2669966|NCT01490840|Secondary|Change From Baseline in Isometric and Dynamic Muscular Strength as Measured by Sit-to-stand Test|The Sit to Stand Test is a functional outcome measure of the lower-extremity muscle power. The test was performed 3 times with one minute rest in between. The best attempt out of three was used for the analysis. A positive change from baseline indicates improvement.|baseline, 6 months|The ModFAS, which included participants with sufficient e-training compliance, was considered for the analysis. Only participants with both baseline and month 6 values were analyzed.|||watt/kilogram body weight||95% Confidence Interval|Least Squares Mean
2669967|NCT01490840|Primary|Change From Baseline in Fatigue as Measured by the Modified Fatigue Impact Scale (mFIS ).|The mFIS provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. It is a 21-item, structured, self-report questionnaire that generally can be completed with little or no intervention from an interviewer. The mFIS score ranged from 0 (not tired) to 84 (tired). A negative change from baseline indicates improvement.|Baseline, 6 months|Modified Full Analysis Set (ModFAS): The ModFAS included participants with sufficient e-training compliance.|||score on a scale||95% Confidence Interval|Least Squares Mean
2669968|NCT01490814|Secondary|Number of Cardiovascular Hospitalizations|The total number of cardiovascular hospitalizations reported over the duration of the study.|33 months|Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population.|||number of cardiovascular hospitalization|||Number
2669969|NCT01490814|Secondary|Number of Subjects Reporting a Cardiovascular Hospitalization Over the Duration of the Study.||33 months|Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population.|||Participants|||Count of Participants
2669970|NCT01490814|Secondary|Total Time of Fluoroscopy||Fluoroscopy meter time through the initial ablation procedure|Subjects randomized and received ablation procedure. Modified intent-to-treat (mITT) population|||minutes||Standard Deviation|Mean
2669971|NCT01490814|Secondary|Total Procedure Duration||Through the initial ablation procedure|Subjects randomized and received ablation. Modified intent-to-treat (mITT) population.|||minutes||Standard Deviation|Mean
2669972|NCT01490814|Secondary|Arrhythmia-related Death||33 months|Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population.|||Participants|||Count of Participants
2669973|NCT01490814|Secondary|All-cause Death||33 months|Subjects randomized and received ablation. Modified intent-to-treat (mITT) population.|||Participants|||Count of Participants
2669974|NCT01490814|Primary|Number of Subjects With a Primary Safety Event. A Primary Safety Event Includes a Composite of Death (Including Cardiovascular Death), All-cause Stroke/Transient Ischemic Attack (TIA) and Serious Adverse Events of Special Interest.||33 months|Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population.|||Participants|||Count of Participants
2669975|NCT01490814|Primary|Number of Subjects With Recurrence of Atrial Arrhythmias or Prescription of Anti-arrhythmic Drug or Re-ablation After a Blanking Period of Three Months After the Initial Ablation Procedure|Number of subjects reporting a primary efficacy endpoint|33 months|Subjects randomized and received an ablation procedure. Modified intent-to-treat (mITT) population.|||Participants|||Count of Participants
2669976|NCT01490788|Primary|Incidences of Adverse Events|Every adverse events occurring during the study period will be reported.|Continuously until the end (day 5) of each study period + 8-10 days after end of last period (total duration: about 1 month)||||Participants|||Count of Participants
2669977|NCT01490788|Primary|Mean Plasma Concentration (AUC) of Cyclobenzaprine|Blood samples were collected pre-dose, 30 min, 1, 1.5, 2, 2.5, 3, 3.33, 3.67, 4, 4.67, 5, 5.5, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose for each treatment period.|0 to 96 hours||||pg.hr/mL||Full Range|Mean
2669978|NCT01490697|Secondary|Change From Baseline in the Impact of Event Scale-Revised (IES-R) Total Score|IES-R is a 22-item patient reported measure of PTSD symptoms. Each question is answered using a 5-point scale where 0=not at all to 4=extremely for a total possible score of 0 to 88. Lower scores represent less severe symptoms and higher scores representing more severe symptoms. IES-R change scores were calculated by subtracting the Day 14 IES-R total score from the Day 7 IES-R total score. A negative change from Baseline indicates improvement of symptoms and a positive change from Baseline indicates a worsening of symptoms.|Day 7 (Baseline) and Day 14|All randomized participants included in the analysis. Three participants did not meet PTSD diagnostic criteria and are excluded.|||score on a scale||Standard Deviation|Mean
2669979|NCT01490697|Primary|Physiological Posttraumatic Stress Disorder (PTSD) Probability as Determined From Psychophysiologic Responses to Traumatic Recollection|The posterior probability of developing PTSD was determined for each participant from a composite of psychophysiological responses to script-driven imagery of traumatic events that included assessments of heart rate response in beats per minute, skin conductance response in microSiemens, and corrugator electromyogram (EMG) responses of the left lateral frontalis facial muscle in microVolts. Responses for the traumatic scripts were averaged and square-root transformed for analysis. Responses during personal traumatic imagery of previously studied individuals with and without current PTSD was used to calculate each participant's posterior probability of being classified as PTSD.|1 week following treatment (Day 14)|All randomized participants included in the analysis. Three participants did not meet PTSD diagnostic criteria and are excluded.|||percent probability||Standard Deviation|Mean
2669980|NCT01490684|Secondary|Length of Stay in the Hospital|Patients will be followed for up to 180 days.Patinets alive in the hospital beyond 180 days of stay will have a hospital length of stay of 180 days.|date of discharge from hospital minus date of admission to hospital||||days||Standard Deviation|Mean
2669981|NCT01490684|Secondary|Length of Stay in the ICU|Patients will be followed for up to 180 days.Patinets alive in the ICU beyond 180 days of stay will have an ICU length of stay of 180 days.|date of discharge from ICU minus date of admission to ICU||||days||Standard Deviation|Mean
2669982|NCT01490684|Secondary|Duration of Mechanical Ventilation|If multiple intubations in the same admission, then the durations of mechanical ventilation will be added.This will be assessed for up to 180 days of stay in the ICU.|date of extubtation minus date of intubation|||||||
2669983|NCT01490684|Secondary|ICU Mortality|If patients are still alive in the ICU at 180 days after entring the sudy, they will be considered ICU survivors.|patients will be followed until discharge from the hospital and vital status at discharge from the hospital will be noted (expected hospital stay is 5 weeks). Hopsital mortality will be censored at 180 days after entry into the study.||||Participants|||Count of Participants
2669984|NCT01490684|Primary|Hospital Mortality|For patients staying in the ICU for long periods, hospital mortality will be censored at 180 days after entry into the study.That is patient staying alive in the hospital more than 180 days will be considered alive.|Patients will be followed while in the ICU and the vital status at the time of discharge from the ICU will be noted. The expected stay in the ICU is 10 days on average.||||Participants|||Count of Participants
2669985|NCT01490632|Secondary|PK: Area Under the Concentration-Time Curve Versus Time During One Dosing Interval at Steady State (AUC τ,ss)||Day 1:15 minutes(m) to 30m and 1hour(h) to 3h Postdose; Week 1:Predose; Week 4:Predose; Week 8:Predose; 15m to 30m and 1h to 3h Postdose, Week 12:Predose; Weeks 14 and 20; Week 24:Predose; Week 28; Week 40. If applicable: Weeks 4, 24, and 52 Post-Relapse|All randomized participants who received ≥1 dose of study drug in Part A, had evaluable PK, and participated in Part A, B or C. Some participants received 4mg or 8 mg and increased to 8mg or 10 mg, depending on the response at week 12. Those participants are treated as separate participants in each dose group.|||nanomole*hour (nM*h)||Geometric Coefficient of Variation|Geometric Mean
2669986|NCT01490632|Secondary|Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib||Day 1:15 minutes(m) to 30m and 1hour(h) to 3h Postdose; Week 1:Predose; Week 4:Predose; Week 8:Predose; 15m to 30m and 1h to 3h Postdose, Week 12:Predose; Weeks 14 and 20; Week 24:Predose; Week 28; Week 40. If applicable: Weeks 4, 24, and 52 Post-Relapse|All randomized participants who received ≥1 dose of study drug in Part A, had evaluable PK, and participated in Part C. Some participants received 4mg or 8 mg and increased to 8mg or 10 mg, depending on the response at week 12. Those participants are treated as separate participants in each dose group.|||nanomole (nM)||Geometric Coefficient of Variation|Geometric Mean
2669987|NCT01490632|Secondary|Percentage of Participants Experiencing Rebound Upon Discontinuation of Study Drug in Part C|Rebound was defined as worsening of psoriasis compared to baseline at Week 0 (for example, PASI score >125% of baseline value) or new pustular, erythrodermic, or more inflammatory psoriasis occurring within 3 months of stopping study drug.|Week 40|All randomized participants who received ≥1 dose of study drug in Part A and participated in Part C.|||Percentage of Participants|||Number
2669988|NCT01490632|Secondary|Change From Baseline Part D in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores|"The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine. This information is used as a quantitative measure of health outcome."|Baseline Part D, Week 92|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. Missing values were imputed with the last observation carried forward (LOCF) method.|||mm||Standard Deviation|Mean
2669989|NCT01490632|Secondary|Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores|"The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine. This information is used as a quantitative measure of health outcome."|Baseline Part A, Week 24|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. As observed values were used.|||mm||Standard Deviation|Mean
2669990|NCT01490632|Secondary|Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores|"The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine. This information is used as a quantitative measure of health outcome. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects."|Baseline Part A, Week 12|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. As observed values were used.|||Millimeter (mm)||Standard Error|Least Squares Mean
2669991|NCT01490632|Secondary|Change From Baseline Part D in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 92|The QIDS-SR16 is a 16-item, self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (APA 1994). A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 to 3. The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The domains assessed by the instrument include: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation, (5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation.|Baseline Part D, Week 92|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Deviation|Mean
2669992|NCT01490632|Secondary|Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 24|The QIDS-SR16 is a 16-item, self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (APA 1994). A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 to 3. The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The domains assessed by the instrument include: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation, (5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation.|Baseline Part A, Week 24|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. As observed values were used.|||Units on a Scale||Standard Deviation|Mean
2669993|NCT01490632|Secondary|Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score at Week 12|The 16-item QIDS-SR16 version is a widely used validated scale designed to assess the severity of depressive symptoms. The participant was asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27, where higher scores indicate higher severity of symptoms. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.|Baseline Part A, Week 12|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Error|Least Squares Mean
2669994|NCT01490632|Secondary|Change From Baseline Part D in Itch Numeric Rating Scale (Itch NRS) Score to Week 92|"The Itch NRS is a participant-administered, 11‑point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours."|Baseline Part D, Week 92|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Deviation|Mean
2669995|NCT01490632|Secondary|Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score to Week 24|"The Itch NRS is a participant-administered, 11‑point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours."|Baseline Part A, Week 24|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Deviation|Mean
2669996|NCT01490632|Secondary|Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score at Week 12|"The Itch NRS is a participant-administered, 11‑point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects."|Baseline Part A, Week 12|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Error|Least Squares Mean
2669997|NCT01490632|Secondary|Change From Baseline Part D in Dermatology Life Quality Index (DLQI) Total Score to Week 92|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant."|Baseline Part D, Week 92|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Deviation|Mean
2669998|NCT01490632|Secondary|Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 24|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant."|Baseline Part A, Week 24|All randomized participants who received ≥1 dose of study drug in Part B and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Deviation|Mean
2669999|NCT01490632|Secondary|Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 12|"The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a lot, and very much, with corresponding scores of 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects."|Baseline Part A, Week 12|All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Error|Least Squares Mean
2670000|NCT01490632|Secondary|Change From Baseline in Part D in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 92 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.|Baseline Part D, Week 92|All randomized participants who received ≥1 dose of study drug and has 1 post-baseline observation at or prior to week 92. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Deviation|Mean
2670094|NCT01490190|Primary|Number of Bleeding Days Per Cycle|Intermenstrual vaginal bleeding that required >=2 pads per day was classified as BLEEDING.|Up to 84 days (three 28-day cycles)|One participant in Per Protocol Population who experienced vaginal bleeding was evaluated for duration of bleeding.|||Days||Standard Deviation|Mean
2670001|NCT01490632|Secondary|Change From Baseline in Part A in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 24 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis: Measure: Psoriasis Area and Severity Index [PASI])|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.|Baseline Part A, Week 24|All randomized participants who received at least one dose of study drug and at least 1 post-baseline observation in Part A at or prior to week 24. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Deviation|Mean
2670002|NCT01490632|Secondary|Change From Baseline in Part A in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 12 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. Least Squares Means (LS Means) were calculated using an analysis of covariance (ANCOVA) model on the last observation carried forward (LOCF) with treatment group as a fixed effect and baseline PASI score as a continuous covariate.|Baseline Part A, Week 12|All randomized participants who received at least one dose of study drug. Missing values were imputed with the last observation carried forward (LOCF) method.|||Units on a Scale||Standard Error|Least Squares Mean
2670003|NCT01490632|Secondary|Percentage of Participants Achieving an sPGA of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])|The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.|Week 92|All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.|||Percent of Participants|||Number
2670004|NCT01490632|Secondary|Percentage of Participants Achieving an sPGA of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])|The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.|Week 24|All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.|||Percent of Participants|||Number
2670005|NCT01490632|Secondary|Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])|The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.|Week 12|All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.|||Percent of Participants|||Number
2670006|NCT01490632|Primary|Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])|The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema (redness), and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.|Week 12|North American (NA) modified intent-to-treat (mITT) population: All NA randomized participants who received at least one dose of study drug. Non-responders and participants who discontinued study drug any time prior to time point of interest, or discontinued from study, were defined as non-responders for the non-responder imputation (NRI) analysis.|||Percent of Participants|||Number
2670007|NCT01490580|Secondary|Transcutaneous PCO2 (TcPCO2) Measurement|TcPCO2 recordings 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first injection|from 1 minute before to 60 minutes after the start of premedication|Changes in TcPCO2 from baseline were analyzed at predefined time points. Values were missing at some time points.|||Difference in mm Hg||Standard Deviation|Mean
2670008|NCT01490580|Secondary|Mean Blood Pressure|Blood pressure recordings 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first injection|from 1 minute before to 60 minutes after the start of premedication|Changes from baseline in mean arterial blood pressure (MAP) were analyzed at predefined time points. Values were missing at some time points.|||Difference in mm Hg||Standard Deviation|Mean
2670009|NCT01490580|Secondary|Pulse Oxymetry|Pulse oxymetry recordings 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first injection|from 1 minute before to 60 minutes after the start of premedication|Changes in SpO2 value from baseline were analyzed at predefined time points. Data was missing at some time points.|||% SpO2||Standard Deviation|Mean
2670010|NCT01490580|Secondary|Long Term Neurodevelopmental Outcome|Age and stages questionnaire|At 2 years corrected age||2020-04-30|04/2020||||
2670392|NCT01486966|Secondary|Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment|FPG target was < 6.0 mmol / L, 2hPPG target was < 8.0 mmol / L.|Week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.|||percentage (%) of subjects|||Number
2670011|NCT01490580|Secondary|Short Term Neurological Outcome: Worsening of Head Ultrasound|Worsening of head ultrasound scans in the 7 days after intubation from the preinclusion evaluation, defined as either a normal scan before inclusion and any grade intraventricular hemorrhage (IVH) afterwards, or as a preinclusion grade 1 or 2 IVH scan deteriorating to grade 3 or 4 IVH, according to Papile's classification; This analysis was not centralized but performed in each center according to its usual protocols.|Within 7 days after inclusion||||Participants|||Count of Participants
2670012|NCT01490580|Secondary|Heart Rate|Heart rate recordings 1 minute before the first injection and at 3, 6, 9, 12, 15, 30, 45 and 60 minutes after the first injection|from 1 minute before to 60 minutes after the start of premedication||||bpm||Standard Deviation|Mean
2670013|NCT01490580|Secondary|Duration of Intubation Procedure|Although the initial definition of procedure duration in the registered protocol was the time between the first laryngoscope insertion and last laryngoscope removal after successful intubation, the variable collected in the clinical research form was defined as the time between first laryngoscope insertion and the fixation of the tube with tape.|Expected duration 1 to 15 minutes||||Minutes||Inter-Quartile Range|Median
2670014|NCT01490580|Secondary|Number of Intubation Attempts||During intubation procedure, expected duration 1 to 15 minutes||||Participants|||Count of Participants
2670015|NCT01490580|Primary|Number of Patients With Prolonged Desaturation|"Pulse oxymetry value measured by Masimo technology below 80% for 60 seconds or more.~Duration of intubation is defined by the time between first laryngoscope insertion and last laryngoscope removal after successful intubation. Successful intubation is defined by clear bilateral breath sounds, increasing heart rate and saturation (if previously low) and appropriate flow curves on the ventilator."|During intubation procedure, expected duration 1 to 15 minutes||||Participants|||Count of Participants
2670016|NCT01490359|Secondary|Multiple Vaginal Partners in the Past 3 Months|The report of having vaginal intercourse with 2 or more women in the past 3 months.|Baseline, 6 months, 12 months post intervention|Participants with data at baseline and at least one post-intervention assessment.|||Participants|||Count of Participants
2670017|NCT01490359|Secondary|Heterosexual Anal Intercourse in the Past 3 Months|The report of having anal intercourse with a woman in the past 3 months|Baseline, 6 months, 12 months post intervention|Participants with data at baseline and at least one post-intervention assessment.|||Participants|||Count of Participants
2670018|NCT01490359|Secondary|Condomless Vaginal Intercourse in the Past 3 Months|A binary variable indicating whether participant reported having vaginal intercourse without using a condom in the past 3 months (0 = did not have vaginal intercourse or always used a condom; 1= did have vaginal intercourse without using a condom)|Baseline, 6 months, and 12 months post-intervention|Participants with data at baseline and at least one post-intervention assessment.|||Participants|||Count of Participants
2670019|NCT01490359|Secondary|Talked to Partner About Condom Use|A binary variable indicating whether the participants talked to partner about using condoms in the past 90 days.|Baseline, 6 months, 12 months post intervention|Participants with data at baseline and at least one post-intervention assessment.|||Participants|||Count of Participants
2670020|NCT01490359|Secondary|Frequency of Condom Use in the Past 3 Months|Respondents' rating on a 5-point scale from 1 (never) to 5 (always) how often they used a condom during vaginal intercourse. Measured separately for steady and casual partners.|Baseline, 6 months, 12 months post intervention|Participants with data from baseline and at least one post-intervention assessment.|||units on a scale||Standard Error|Mean
2670021|NCT01490359|Secondary|Self-reported Condom Use at Most Recent Vaginal Intercourse|The respondents' self-report of using a condom during their most recent vaginal intercourse. Calculated separately for steady and casual partners.|Baseline, 6 months, 12 months post intervention|Participants with data at baseline and at least one post-intervention assessment.|||Participants|||Count of Participants
2670022|NCT01490359|Secondary|The Self-reported Proportion of Condom-protected Acts of Vaginal Intercourse in the Past 3 Months|The proportion of condom-protected acts of vaginal intercourse is defined as the self-reported number of acts of vaginal intercourse in which the respondent used a condom in the past 3 months divided by the total number of acts of vaginal intercourse the respondent reported in the past 3 months. Calculated separately for steady and casual partners.|Baseline, 6 months, 12 months post intervention|Participants with data at baseline and at least one post-intervention assessment.|||proportion of acts||Standard Error|Mean
2670023|NCT01490359|Primary|Self-reported Consistent Condom Use During Vaginal Intercourse in the Past 3 Months|Men who reported at least 1 vaginal intercourse act in the past 3 months and whose number of reported condom-protected vaginal intercourse acts equaled their number of vaginal intercourse acts were coded as practicing consistent or 100% condom use. Men who reported at least 1 vaginal intercourse act and whose reported number of condom-protected vaginal intercourse acts was less than their number of vaginal intercourse acts were coded as not practicing consistent condom use. Separate binary variables reflected consistent condom use with primary partners and casual partners.|Baseline, 6 months, 12 months post-intervention|Participants with data at baseline and at least one follow-up.|||Participants|||Count of Participants
2670024|NCT01490294|Secondary|Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation)||Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in FAS with assessment for this outcome measure. Evaluation included all participants in the full analysis population with an assessment for this outcome measure|||Percentage of participants|||Number
2670025|NCT01490294|Secondary|Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure|||Percent segmental assessment|Participants||Number
2670026|NCT01490294|Secondary|Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|PPS. Evaluation included all participants in the per protocol population with an assessment for this outcome measure|||Percent segmental assessment|Participants||Number
2670027|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions|"Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by the clinical investigator for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.|||Percent regional assessment|Participants||Number
2670028|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments|"Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by the clinical investigator for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 16 myocardial segments (defined according to AHA)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.|||Percent segmental assessment|Participants||Number
2670029|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments|"Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by 3 blinded readers for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 16 myocardial segments (defined according to AHA)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.|||Percent segmental assessment|Participants||Number
2670030|NCT01490294|Secondary|Percent Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions|"Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by 3 blinded readers for absence/presence of scar on perfusion MR and presence/absence of DE on MR for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation included all participants in the per protocol population with an assessment for this outcome measure.|||Percent regional assessments|Participants||Number
2670031|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Participants|||Number
2670032|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Delayed enhancement assessments|Participants||Number
2670033|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Participants|||Number
2670034|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Delayed enhancement assessments|Participants||Number
2670035|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment|||Participants|||Number
2670095|NCT01490190|Primary|Number of Participants With Intermenstrual Bleeding/Spotting|Number of participants who experienced vaginal bleeding, which includes BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. Vaginal bleeding that required >=2 pads per day was classified as BLEEDING. Vaginal bleeding that required <=1 pad per day was classified as SPOTTING.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.|||Participants|||Number
2670036|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Delayed enhancement assessments|Participants||Number
2670037|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Participants|||Number
2670038|NCT01490294|Secondary|Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Delayed enhancement assessments|Participants||Number
2670039|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Participants|||Number
2670040|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Delayed enhancement assessments|Participants||Number
2670041|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Participants|||Number
2670042|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.|Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Delayed enhancement assessments|Participants||Number
2670043|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Participants|||Number
2670044|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized|Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Delayed enhancement assessments|Participants||Number
2670045|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.|Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. Evaluation includes only participants with delayed enhancement in at least 1 segment.|||Participants|||Number
2670046|NCT01490294|Secondary|Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading)|Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Results are displayed on a per patient basis.|Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure. The evaluation included only participants with delayed enhancement in at least 1 segment ( PPS) based on the assessment of at least one blinded reader.|||Delayed enhancement assessments|Participants||Number
2670047|NCT01490294|Secondary|Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments|"Delayed enhancement (DE)-[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points were evaluated by the respective investigator regarding the presence/absence of delayed enhancement at 5 - 20 minutes post injection in 16 myocardial segments (defined according to the American Heart Association). DE data were compared to the diagnosis scar derived from SPECT. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by the investigator."|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 segment in SPECT were included."|||Percent segmental assessment|Participants||Number
2670048|NCT01490294|Secondary|Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions|"Delayed enhancement (DE) -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points, were evaluated by the clinical investigator for presence/absence of DE at 5 - 20 minutes post injection in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). DE data were compared to the diagnosis scar derived from SPECT. The number of regional assessments is defined as the number of regions with diagnosis scar assessed by the investigator."|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 region in SPECT were included."|||Percent regional assessments|Participants||Number
2670049|NCT01490294|Secondary|Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments|"Delayed enhancement -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points were evaluated by 3 independent blinded readers regarding the presence/absence of DE at 5 - 20 minutes post injection in 16 myocardial segments (defined according to the American Heart Association). DE data were compared to the diagnosis scar derived from SPECT. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by at least 1 blinded reader."|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 segment in SPECT were included."|||Percent segmental assessments|Participants||Number
2670050|NCT01490294|Secondary|Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions|"Delayed enhancement (DE) -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points, were evaluated by 3 independent blinded readers for presence/absence of DE at 5 - 20 minutes post injection in 3 myocardial regions representing the 3 arterial territories of the heart. DE data were compared to the diagnosis scar derived from SPECT. The number of regional assessments is defined as the number of regions with diagnosis scar assessed by at least 1 blinded reader."|Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only participants with the finding scar in at least 1 segment in SPECT were included."|||Percent regional assessments|Participants||Number
2670051|NCT01490294|Secondary|Time to Peak Based on Segments|"Time to peak is defined as the time in seconds from start to maximum signal intensity (SI max) on the SI curve and was evaluated for normal and for diseased (i.e. ischemia/scar/mixed) segments in order to assess a potential difference (normal/diseased was defined by central reading of SPECT)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration up to 2 minutes|PPS|||Seconds||Standard Deviation|Mean
2670052|NCT01490294|Secondary|Upslope Based on Segments|"Upslope is defined as the maximum slope of the signal intensity (SI) increase on the SI/time curve (determined by a linear fit) during 3 consecutive heart beats reported in Units/sec. The upslope was evaluated for normal and for diseased (i.e. ischemia/scar/mixed) segments in order to assess a potential difference (normal/diseased was defined by central reading of SPECT)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Units/sec||Standard Deviation|Mean
2670053|NCT01490294|Secondary|Signal Intensity (SIrel) Based on Segments|"The signal intensity (SIrel) is determined over time. SI (SIrel) is the upslope in myocardium divided by upslope of the ventricle, as assessed for normal and underperfused segments. SI(rel) = upslope myocard / upslope ventricle. MR segments were evaluated for signal intensity (SIrel) in order to assess if a difference between normal and diseased (i.e. ischemia/scar/mixed) segments could be demonstrated (normal/diseased was defined by central reading of SPECT)."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Signal intensity||Standard Deviation|Mean
2670054|NCT01490294|Secondary|Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments|Rest and stress perfusion MR images were visually evaluated by 3 blinded readers. The MPRI was calculated by an independent MR expert. Analysis was performed for 16 myocardial segments (defined according to the American Heart Association). Visual and semiquantitative data were compared to each other per segment. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent segmental assessments|Participants||Number
2670055|NCT01490294|Secondary|Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions|Rest and stress perfusion MR images were visually evaluated by 3 blinded readers. The MPRI was calculated by an independent MR expert. Analysis was performed for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA): Visual and semiquantitative data were compared to each other per region. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent regional assessments|Participants||Number
2670056|NCT01490294|Secondary|"Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments"|MPRI was calculated as decribed in outcome measure 22 on stress and rest perfusion MR images by an independent MR expert for 16 myocardial segments (defined according to the American Heart Association). MPRIs <= 1.5 (perfusion defect) and >1.5 (normal) were then compared to presence/absence of perfusion defects in the segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent segmental assessments|Participants||Number
2670057|NCT01490294|Secondary|"Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI) (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions"|MPRI was calculated as decribed in outcome measure 22 on stress and rest perfusion MR images by an independent MR expert for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MPRIs <= 1.5 (perfusion defect) and >1.5 (normal) were compared to presence/absence of perfusion defects in the regional data analysis from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent regional assessments|Participants||Number
2670058|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions|For patients undergoing coronary angiography additionally to SPECT, a Truth Panel with 2 cardiology experts was employed as SoT to come to a consensus diagnosis. Rest and stress MR images were evaluated by 3 independent blinded readers for presence/absence of perfusion defects in 3 myocardial regions representing the 3 arterial territories/arteries of the heart. These data were compared to the SoT diagnosis. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure|||Percent regional assessments|Participants||Number
2670059|NCT01490294|Secondary|"Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter Myocardial Perfusion Reserve Index (MPRI)  (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions)"|MPRI was calculated for the upslope of the signal intensity /time curve on stress and rest perfusion MR images by an independent MR expert for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). The upslope-value at post-stress was divided by the value at rest. MPRI <=1.5 (perfusion defect) and >1.5 (normal) were compared to coronary angiography regarding presence/absence of significant coronary artery stenosis of >70%. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure|||Percent regional assessments|Participants||Number
2670060|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses|Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to coronary angiography regarding presence/absence of significant coronary artery stenosis of > 70%. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|All participants in PPS with assessment for this outcome measure|||Percent regional assessments|Participants||Number
2670061|NCT01490294|Secondary|Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments|Rest and stress MR images were evaluated by the investigator regarding the presence/absence of artifacts in 16 myocardial segments (defined according to the American Heart Association). The number of segments with artifacts was calculated by multiplication of the number of participants with the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percentage of segments with artifacts|Participants||Number
2670062|NCT01490294|Secondary|Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments|Rest and stress MR images were evaluated by 3 independent blinded readers regarding the presence/absence of artifacts in 16 myocardial segments (according to the American Heart Association). The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percentage of segments with artifacts|Participants||Number
2670063|NCT01490294|Secondary|Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments|Rest and stress perfusion and DE MR images were evaluated by 3 independent blinded readers regarding the detailed characterization of cardiac perfusion deficits i.e scar, ischemia or a mixture of both in 16 myocardial segments (defined according to the American Heart Association). MR data were compared to the corresponding segmental data derived from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent segmental assessments|Participants||Number
2670096|NCT01490190|Primary|Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring|Intensity of menstruation, as indicated by the median number of pads used per day by participants during each cycle of NuvaRing use.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol. Of the total Per Protocol Population (N = 204), data for this outcome measure were missing for 3 partcipants in the first cycle, 1 participant in the second cycle, and 1 participant in the third cycle.|||Pads||Full Range|Median
2670064|NCT01490294|Secondary|Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions|Rest and stress perfusion and DE MR images were evaluated by 3 independent blinded readers regarding the detailed characterization of cardiac perfusion deficits i.e scar, ischemia or a mixture of both, in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent regional assessments|Participants||Number
2670065|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments|Rest and stress perfusion MR images were evaluated by the respective clinical investigator for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or a mixture of both in 16 myocardial segments (defined according to the American Heart Association).MR data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent segmental assessments|Participants||Number
2670066|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions|Rest and stress perfusion MR images were evaluated by the respective clinical investigator for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent regional assessments|Participants||Number
2670067|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments|Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 16 myocardial segments (defined according to the American Heart Association). MR data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent segmental assessment|Participants||Number
2670068|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions|Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 3 myocardial regions representing 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent regional assessments|Participants||Number
2670069|NCT01490294|Secondary|"Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments"|"Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as ischemia in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of ischemia. The number of segmental assessments is defined as the number of segments with diagnosis ischemia assessed by the investigator."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 segment in SPECT were included."|||Percent segmental assessments|Participants||Number
2670070|NCT01490294|Secondary|"Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions"|"Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as ischemia in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of ischemia. The number of regional assessments is defined as the number of regions with diagnosis ischemia assessed by the investigator."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 region in SPECT were included."|||Percent regional assessments|Participants||Number
2670071|NCT01490294|Secondary|"Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments"|"Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as ischemia in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of ischemia. The number of segmental assessments is defined as the number of segments with diagnosis ischemia assessed by at least 1 blinded reader."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 segment in SPECT were included."|||Percent segmental assessment|Participants||Number
2670072|NCT01490294|Secondary|"Diagnosis Ischemia: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions"|"Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as ischemia in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of ischemia.The number of regional assessments is defined as the number of regions with diagnosis ischemia assessed by at least 1 blinded reader."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding ischemia in at least 1 region in SPECT were included."|||Percent regional assessments|Participants||Number
2670073|NCT01490294|Secondary|"Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments"|"Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as scar in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental SPECT diagnosis of scar. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by the investigator."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 segment in SPECT were included."|||Percent segmental assessments|Participants||Number
2670074|NCT01490294|Secondary|"Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions"|"Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as scar in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of scar. The number of regional assessments is defined as the number of segments with diagnosis scar assessed by the investigator."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 region in SPECT were included."|||Percent regional assessments|Participants||Number
2670075|NCT01490294|Secondary|"Diagnosis Scar: Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Segments"|"Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as scar in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of scar. The number of segmental assessments is defined as the number of segments with diagnosis scar assessed by at least 1 blinded reader."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 segment in SPECT were included."|||Percent segmental assessments|Participants||Number
2670076|NCT01490294|Secondary|Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions|"Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as scar in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of 'scar'. The number of regional assessments is defined as the number of regions with diagnosis 'scar' assessed by at least 1 blinded reader."|Immediately within approximately 5 seconds after Gadobutrol bolus administration|"All participants in PPS with assessment for this outcome measure. Only patients with the finding scar in at least 1 region in SPECT were included."|||Percent regional assessments|Participants||Number
2670077|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments|Rest and stress perfusion MR images were evaluated by the respective investigator for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent segmental assessments|Participants||Number
2670078|NCT01490294|Secondary|Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions|Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|PPS|||Percent regional assessments|Participants||Number
2670079|NCT01490294|Primary|Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments|Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|Per protocol set (PPS)|||Percent segmental assessment|Participants||Number
2670145|NCT01489670|Secondary|Physician Evaluation of Tolerability of Treatment|The physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The percentage of participants assessed in each category is reported.|Week 12|All participants with data available for this outcome measure.|||Participants|||Number
2670080|NCT01490294|Primary|Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions|Rest and stress perfusion Magnetic Resonance (MR) images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (left anterior decendent [LAD], left circumflex [LCX], right coronary artery [RCA]). Data were compared to the corresponding regional data from Single Photon Emission Computer Tomography (SPECT). The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and number of the myocardial regions.|Immediately within approximately 5 seconds after Gadobutrol bolus administration|Per protocol set (PPS)|||Percent regional assessments|Participants||Number
2670081|NCT01490190|Secondary|Number of Participants Who Reported a Serious Adverse Event During the Study|A serious adverse event is any adverse drug or biologic or device experience that results in death, a life-threatening adverse event, persistent or significant disability or incapacity; requires in-patient hospitalization, or prolonged hospitalization; or causes a congenital anomaly or birth defect.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.|||Participants|||Number
2670082|NCT01490190|Secondary|Number of Participants Who Reported at Least One Adverse Event During the Study|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic, or medical device, which does not necessarily have a causal relationship with the treatment.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.|||Participants|||Number
2670083|NCT01490190|Secondary|Number of Pregnancies Due to Contraceptive Method Failure During the Study|For participants with suspected pregnancy during in-treatment period, pregnancy was to be confirmed by hCG qualitative analysis using strip and/or other test(s) at the discretion of the treating physician.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.|||Pregnancies|||Number
2670084|NCT01490190|Primary|Number of Participants Who Would Recommend Vaginal Ring to Others|Participants were asked at follow-up visits after every cycle whether they would recommend NuvaRing to other women, and their answers were reported.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.|||Participants|||Number
2670085|NCT01490190|Primary|Number of Participants Who Plan to Continue Using Vaginal Ring|Participants were asked at follow-up visits after every cycle whether they planned to continue using NuvaRing, and their answers were recorded.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.|||Participants|||Number
2670086|NCT01490190|Primary|Participants' Overall Satisfaction With Vaginal Ring|Participants were asked to characterize their overall satisfaction with the NuvaRing as one of the following: very satisfied, satisfied, neutral, unsatisfied, or very unsatisfied. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.|||Participants|||Number
2670087|NCT01490190|Primary|Frequency of Partner Objecting to Vaginal Ring Use|Participants were asked if their partners objected to their using the NuvaRing during intercourse and to characterize the frequency of their partners' objections as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.|||Participants|||Number
2670088|NCT01490190|Primary|Frequency of Partner Feeling Vaginal Ring During Intercourse|Participants were asked if their partners could feel the NuvaRing during intercourse and to characterize their partners' experience as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.|||Participants|||Number
2670089|NCT01490190|Primary|Participants' Assessment of Feeling Vaginal Ring During Intercourse|Participants were asked to assess whether they could feel the NuvaRing during intercourse and to characterize how often as one the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.|||Participants|||Number
2670090|NCT01490190|Primary|Participants' Assessment of Feeling Vaginal Ring at Any Time|Participants were asked to assess whether they could feel the NuvaRing at any time and to characterize how often as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.|||Participants|||Number
2670091|NCT01490190|Primary|Participants' Assessment of Ease of Removal of Vaginal Ring|Participants were asked to classify their ability to remove the NuvaRing as very easy, easy, neutral, difficult, very difficult, or failed. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.|||Participants|||Number
2670092|NCT01490190|Primary|Participants' Assessment of Ease of Insertion of Vaginal Ring|Participants were asked to classify their ability to insert the NuvaRing as very easy, easy, neutral, difficult, very difficult, or failed. The number of participants who responded to each category was reported.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.|||Participants|||Number
2670093|NCT01490190|Primary|Number of Spotting Days Per Cycle|Intermenstrual vaginal bleeding that required <=1 pad per day was classified as SPOTTING.|Up to 84 days (three 28-day cycles)|Participants in the Per Protocol Population who experienced spotting were evaluated for duration of spotting.|||Days||Standard Deviation|Mean
2670097|NCT01490190|Primary|Average Number of Bleeding Days Per Cycle|Mean duration of menstruation, per day, per cycle, during the study period.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol. Of the total Per Protocol Population (N = 204), data for this outcome measure were missing for 3 partcipants in the first cycle, 1 participant in the second cycle, and 1 participant in the third cycle.|||Days||Standard Deviation|Mean
2670098|NCT01490190|Primary|Number of Participants With Regular Menstrual Cycles|The number of participants who experienced regular menstrual bleeding patterns throughout the period of NuvaRing use. Bleeding patterns were to be characterized by particpants as regular or irregular.|Up to 84 days (three 28-day cycles)|Per Protocol Population, which included all participants who completed the study as per protocol.|||Participants|||Number
2670099|NCT01490151|Primary|Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions|A successful hospital admission was defined as requiring no more than 2 TTR closed-loop control system adjustments of algorithm tuning parameters after initial set up, and not meeting any stopping criteria. The system was considered feasible if 75% of hospital admissions were successful.|Day of hospital admission (12 hours)|A total of 25 admissions were completed. 1 participant was admitted twice in Cohort A1, and 2 participants were admitted first in Cohort A1 and then again in Cohort B.|||Admissions|Admissions||Count of Units
2670100|NCT01490125|Secondary|Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Used Over the 6 Weeks of Treatment|The number of puffs of rescue medication taken by participants, were collected each day during the study via entries in e-diaries|Baseline and 6 weeks|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.|||puffs||Standard Deviation|Least Squares Mean
2670101|NCT01490125|Secondary|Change From Baseline in The Capacity of Daily Living During the Morning (CDLM) Score Averaged Over 6 Weeks of Treatment|"The Capacity of Daily Living during the Morning (CDLM) is a self-administered daily assessment. The CDLM asks COPD patients to (i) report their ability to carry out 6 morning activities and (ii) rate the difficulty in performing those activities on a five point Likert-type scale ranging from not at all difficult to extremely difficult. For each of the six morning activities a score ranging from 0 (=so difficult that they could not carry out the activity by themselves) to 5 (not at all difficult to carry out the activity by themselves) is calculated by using the responses from the two questions for each activity. Daily CDLM is calculated using the scores average from the 6 morning activities. CDLM is calculated as the average daily CDLM score over 6 weeks of treatment. The change from baseline in CDLM score over 6 weeks is analyzed using a MIXED model with baseline CDLM score as a covariate. A CDLM score of 0.20 is considered to be a minimal clinically important difference."|Baseline and 6 weeks|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.|||Units on a scale||Standard Error|Least Squares Mean
2670102|NCT01490125|Secondary|Standardized Forced Vital Capacity (FVC) Area Under the Curve (AUC) 5min-4 Hrs After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium|Forced Vital Capacity (FVC) is the total amount of air that can be exhaled by the patient after a full inhalation. The FVC was measured via spirometry conducted according to internationally accepted standards at 5 min-4 hr post dose of day 1 and week 6.|5min-4hr at day 1 and week 6 post-dose|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.|||Liters||Standard Error|Least Squares Mean
2670103|NCT01490125|Secondary|Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 5min-4h After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium|Forced Expiratory Volume in 1 second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were taken at 5 min- 4hr post-dose of day 1 and week 6. The standardized FEV1 Area under the curve (AUC) was calculated as the sum of trapezoids divided by the length of time.|5min-4hr at day 1 and week 6 post-dose|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.|||Liters||Standard Error|Least Squares Mean
2670104|NCT01490125|Secondary|Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Tiotropium|Total Transient Dyspnea Index (TDI) is part of the BDI/TDI questionnaire where participants indicated whether they improved or deteriorated since their Baseline Dyspnea Index (BDI). The BDI and TDI each had 3 domains: activities, tasks, and effort. BDI domains were rated from 0 (very severe) to 4 (none) and the rates summed for the total BDI score ranging from 0 to 12; the lower the score the worse the severity of dyspnea. TDI domains were rated from -6 (major deterioration) to 6 (major improvement) and the rates summed for the total TDI score ranging from -18 to 18. However, to ensure comparability with the TDI paper version, all TDI values were divided by 2 before the analysis. If data was missing or insufficient for any one of the domains a BDI/TDI was calculated. BDI = Baseline Dyspnea Index taken 75 min prior to the first dose in each treatment period. TDI = Transition Dyspnea Index taken after 6 weeks of treatment 75 min prior to the last dose in each treatment period.|Baseline and 6 weeks|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.|||Units on a scale||Standard Deviation|Mean
2670114|NCT01489969|Other Pre-specified|Duration of Wake After Sleep Onset (WASO)|The secondary efficacy parameter is the duration of wake after sleep onset (WASO) measured by the PSG after 28 nights of the double blind treatment period. WASO was summarized at baseline and after 28 days double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. For each treatment group, the mean score at the end of the 28 nights was compared, adjusting for the baseline score. An ANCOVA model was used. Lower score indicates less waking time and thus considered improvement.|28 days||||minutes||Standard Deviation|Mean
2670105|NCT01490125|Primary|Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo|Total Transient Dyspnea Index (TDI) is part of the BDI/TDI questionnaire where participants indicated whether they improved or deteriorated since their Baseline Dyspnea Index (BDI). The BDI and TDI each had 3 domains: activities, tasks, and effort. BDI domains were rated from 0 (very severe) to 4 (none) and the rates summed for the total BDI score ranging from 0 to 12; the lower the score the worse the severity of dyspnea. TDI domains were rated from -6 (major deterioration) to 6 (major improvement) and the rates summed for the total TDI score ranging from -18 to 18. However, to ensure comparability with the TDI paper version, all TDI values were divided by 2 before the analysis. If data was missing or insufficient for any one of the domains a BDI/TDI was calculated. BDI = Baseline Dyspnea Index taken 75 min prior to the first dose in each treatment period. TDI = Transition Dyspnea Index taken after 6 weeks of treatment 75 min prior to the last dose in each treatment period.|Baseline and 6 weeks|The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.|||Units on a scale||Standard Deviation|Mean
2670106|NCT01490086|Secondary|Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale|The General Psychopathology Scale consists of 16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). The General Psychopathology score is obtained by adding the ratings of each item in the scale, with results ranging from 16 to 112. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.|Baseline to Day 28|The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.|||scores on a scale||Standard Deviation|Mean
2670107|NCT01490086|Secondary|Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale|The Negative Scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking) and is calculated by adding the negative subscale item scores to obtain results ranging from 7 to 49. Minimum score is 7, maximum score is 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.|Baseline to Day 28|The ITT population is comprised of participants who had receiving at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.|||scores on a scale||Standard Deviation|Mean
2670108|NCT01490086|Secondary|Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale|The Positive Scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility) and is calculated by adding the subscale item scores to obtain results ranging from 7 to 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.|Baseline to Day 28|The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.|||scores on a scale||Standard Deviation|Mean
2670109|NCT01490086|Secondary|Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S)|Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject's mental illness. Scores range from 1 (not ill at all) to 7 (among the most extremely ill). A reduction in score indicates an improvement in the subject's condition.|Baseline to Day 28|The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.|||scores on a scale||Standard Deviation|Mean
2670110|NCT01490086|Primary|Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score|PANSS total score comprises Positive (Delusions, Conceptual disorganization, Hallucinatory behavior, Excitement, Grandiosity, Suspiciousness/persecution, Hostility), Negative (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking), and General Psychopathology (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance) Scales. Scores are obtained by adding the ratings of each item in each scale. Range is 7-49 for Positive and Negative scores; 16-112 for General Psychopathology score; and 30-210 for Total score. Higher score reflects worse outcome; larger reduction from baseline reflects better outcome.|Baseline to Day 28|The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.|||scores on a scale||Standard Deviation|Mean
2670111|NCT01490073|Secondary|Provider Ease With Intrauterine Device Insertion Measured on a 100 mm VAS|Provider ease with intrauterine device insertion measured on a 100 mm VAS. VAS (visual analog scale) anchors: 0 indicates easiest insertion imaginable, 100 indicates most difficult insertion imaginable|30-45 minutes after insertion of nitroglycerin ointment||||mm||Standard Deviation|Mean
2670112|NCT01490073|Primary|Patient-reported Pain at Passage of Insertion Device Through Cervix, as Measured on a 100 mm VAS|Patient-reported pain at passage of insertion device through cervix, as measured on a 100 mm VAS. VAS anchors: 0 indicates no pain, and 100 indicates worst pain imaginable.|30-45 minutes after insertion of nitroglycerin ointment||||mm||Standard Deviation|Mean
2670113|NCT01490060|Primary|Complete Response|Complete response (CR) defined as: No emetic episodes and no rescue medications. This is a cross-over designed study, the outcomes by single dose, two doses and control cycles were evaluated by combining the results from both cycle 1 and cycle 2 according to the treatment received.|From Day 1 to Day 5 in two 21-days cycles (Cycle 1 and Cycle 2).|Out of 40 eligible participants, 2 participants had change of treatment, 1 participant was noncompliant and 1 participant had an adverse event related to chemotherapy. 36 participants completed cycle 1 and cycle 2.|||percentage of participants|||Number
2670115|NCT01489969|Other Pre-specified|Number of Awakenings (NOA)|The secondary efficacy parameter is number of awakenings (NOA) measured by the PSG after 28 nights of the double blind treatment period. NOA was summarized at baseline and after 28 days double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. For each treatment group, the mean score at the end of the 28 nights was compared, adjusting for the baseline score. An ANCOVA model was used. Lower score indicates less awakenings and thus considered improvement.|28 days||||Awekenings||Standard Deviation|Mean
2670116|NCT01489969|Primary|Latency to Persistent Sleep|The primary efficacy parameter is Latency to persistent sleep (LPS) measured by the PSG at the first two nights (immediate effect) of the double blind treatment period. LPS was summarized at baseline and after two days double-blind treatment (actual and change from baseline) for each treatment group using descriptive statistics. For each treatment group, the mean score at the end of the two days was compared, adjusting for the baselinescore. An ANCOVA model was used. Lower score indicates reduction in latency to persistent sleep and thus considered improvement|2 days||||minutes||Standard Deviation|Mean
2670117|NCT01489956|Secondary|Compare the Level of KLH-specific Antibodies in the Serum (Samples From Various Time Points) Between Parts A and B|No data available for analyses.|6 months|Data were not collected and therefore no analyses could be performed.||||||
2670118|NCT01489956|Secondary|Other Mechanistic Assessments on Archived Serum Samples Like Anti-KLH Antibodies and Secreted Cytokines (Part B)|No data available for analyses.|6 months|Data were not collected and therefore no analyses could be performed.||||||
2670119|NCT01489956|Secondary|Suppression (or Non-activation) of T Cell Stimulation Index Measured by CFSE Staining After KLH Stimulation (Part B)|No data available for analyses.|Day 42|Data were not collected and therefore no analyses could be performed.||||||
2670120|NCT01489956|Secondary|Suppression (or Non-activation) of Cytokine Secretion Profile of T Cells Stimulated by KLH Following Oral Feeding (Part B)|No data available for analyses.|Day 42|Data were not collected and therefore no analyses could be performed.||||||
2670121|NCT01489956|Secondary|T Cell Stimulation Index Measured by Carboxyfluorescein Diacetate Succinimidyl Ester (CFSE) Staining After KLH Stimulation (Part A)|No data available for analyses.|Days 0, 9, 16|Data were not collected and therefore no analyses could be performed.||||||
2670122|NCT01489956|Secondary|Cytokine Secretion Profile of T Cells Stimulated by KLH (Part A)|No data available for analyses.|Days 0, 9, 16|Data were not collected and therefore no analyses could be performed.||||||
2670123|NCT01489956|Primary|T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part A)|No data available for analyses.|Day 16|Data were not collected and therefore no analyses could be performed.||||||
2670124|NCT01489956|Primary|T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part A)|No data available for analyses|Day 9|Data were not collected and therefore no analyses could be performed.||||||
2670125|NCT01489956|Primary|Participants Demonstrating Tolerance to KLH Using T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part B)|T cell stimulation index (SI) as measured by 3H-thymidine incorporation after in vitro keyhole limpet hemocyanin (KLH) stimulation of peripheral blood mononuclear cells (PBMC). An SI <3 on Day 32 indicated tolerance to KLH. The SI is the ratio of 3H-thymidine incorporation by T cells in the presence of KLH stimulation to 3H-thymidine incorporation by T cells in the absence of stimulation. Higher values correspond with lower tolerance to KLH.|Day 32|Intent-to-treat|||participants|||Number
2670126|NCT01489956|Primary|Participants With a Positive Immune Response to T Cell Stimulation Index (SI) as Measured by 3H-thymidine Incorporation After in Vitro KLH Stimulation of PBMC (Part A)|T cell stimulation index (SI) as measured by 3H-thymidine incorporation after in vitro keyhole limpet hemocyanin (KLH) stimulation of peripheral blood mononuclear cells (PBMC). An SI ≥3 on day 16 will indicate the presence of immune response. The SI is the ratio of 3H-thymidine incorporation by T cells in the presence of KLH stimulation to 3H-thymidine incorporation by T cells in the absence of stimulation. Higher values correspond with lower tolerance to KLH.|Day 16|Intent-to-treat|||participants|||Number
2670127|NCT01489891|Secondary|Likert Four Elements Scale to Evaluate the Satisfaction of Anaesthetist|Define as easiness to reach and maintain the level of sedation and patient comfort during endoscopy: very satisfied, satisfied, neutral, unsatisfied.|8 months||||percentage of participants||95% Confidence Interval|Number
2670128|NCT01489891|Secondary|Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist|Define as easiness to reach the expected objectives for endoscopy without patient interference: very satisfied, satisfied, neutral, unsatisfied.|8 months||||percentage of participants||95% Confidence Interval|Number
2670129|NCT01489891|Secondary|Percentage of Participants With Adverse Events in Both Groups|Hypoxemia (SatO2<90% or >4% if the baseline was under 93%), bradycardia (<60 bpm or >10% from baseline), hypotension (systolic blood pressure under 90 mmHg and/or diastolic 60 mmHg), anaphylactic reaction, aspiration o methaemoglobinemia.|Participants will be followed for the duration of hospital stay, an expected average of 2 hours postprocedure||||percentage of participants||95% Confidence Interval|Number
2670130|NCT01489891|Primary|Rate of Administration of Propofol 1% Required to Obtain Uniform Sedation During Endoscopy|The propofol will be administered by an expert anaesthetist in repeated bolus (10-20 mg each 30-60 seconds) after an initial induction dosage (0.5-0.6 mg/kg ASA (American Society of Anaesthesiologists) I-II or 0.25-0.35 mg/kg ASA III-IV) to obtain an uniform level of sedation (OAAS 3 and bispectral index (BIS) 70-80) and adequate perceived patient tolerance (no gag-reflex, cough, sudden movements).|8 months||||mcg/kg/min||Standard Deviation|Mean
2670131|NCT01489826|Secondary|Maximum Concentration (Cmax) of Cremophor Cycle 1 Day 8|Mean Cmax of Cremophor on Cycle 1 Day 8|Cycle1 - Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|This analysis was performed on all patients who received study drug and for whom PK samples were obtained (the PK analysis population). For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.|||µL/mL||Geometric Coefficient of Variation|Geometric Mean
2670144|NCT01489670|Secondary|Physician Reported Reasons for Early Discontinuation of Treatment|The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient.|12 Weeks|All participants who discontinued treatment early.|||Participants|||Number
2670132|NCT01489826|Secondary|Maximum Concentration (Cmax) of Cremophor Cycle 1 Day 1|Mean Cmax of Cremophor on Cycle 1 Day 1|Cycle1 - Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|This analysis was performed on all patients who received study drug and for whom PK samples were obtained (the PK analysis population). For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.|||µL/mL||Geometric Coefficient of Variation|Geometric Mean
2670133|NCT01489826|Secondary|Maximum Concentration (Cmax) of Dexanabinol Cycle 1 Day 8|Mean Cmax of Dexanabinol on Cycle 1 Day 8|Cycle1 - Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|Concentrations of dexanabinol were not reported for some patients on Days 1 or 8 (including all patients in the 6 mg/kg arm) because the bioanalytical assay, in these instances, was not appropriately validated on the day of the assay. For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2670134|NCT01489826|Secondary|Area Under Curve (AUC) of Cremophor on Cycle 1 Day 8|Geometric mean AUC of Cremophor (0-27hour) on Cycle 1 Day 8.|Cycle 1- Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|This analysis was performed on all patients who received study drug and for whom PK samples were obtained (the PK analysis population). For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.|||µL.h/mL||Geometric Coefficient of Variation|Geometric Mean
2670135|NCT01489826|Secondary|Area Under Curve (AUC) of Cremophor on Cycle 1 Day 1|Geometric mean AUC of Cremophor (0-27hour) on Cycle 1 Day 1.|Cycle 1- Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|This analysis was performed on all patients who received study drug and for whom PK samples were obtained (the PK analysis population). For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.|||µL.h/mL||Geometric Coefficient of Variation|Geometric Mean
2670136|NCT01489826|Secondary|Area Under Curve (AUC) of Dexanabinol on Cycle 1 Day 8|Geometric mean AUC of Dexanabinol (0-infinity) on Cycle 1 Day 8.|Cycle 1- Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|Concentrations of dexanabinol were not reported for some patients on Days 1 or 8 (including all patients in the 6 mg/kg arm) because the bioanalytical assay, in these instances, was not appropriately validated on the day of the assay. For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2670137|NCT01489826|Secondary|Progression Free Survival|Tumour response evaluation using RECIST 1.1. (Assessment by CT scan or MRI).|At Screening and after every 2 cycles of treatment (+/-1 week)|Patients included in this analysis were from the 'Efficacy population', defined as those with a baseline and at least one post-baseline assessment of efficacy.|||Days||Inter-Quartile Range|Median
2670138|NCT01489826|Secondary|Number of Adverse Events (AEs)|AEs will be graded according to the NCI CTCAE v4.03 for cancer clinical trials|30 +/-3 days from the end of the last infusion|The numbers represent the total number of AEs per group. Refer to AE tables for specific information.|||Events|||Number
2670139|NCT01489826|Secondary|Maximum Concentration (Cmax) of Dexanabinol Cycle 1 Day 1|Mean Cmax of Dexanabinol on Cycle 1 Day 1|Cycle1 - Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|Concentrations of dexanabinol were not reported for some patients on Days 1 or 8 (including all patients in the 6 mg/kg arm) because the bioanalytical assay, in these instances, was not appropriately validated on the day of the assay. For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2670140|NCT01489826|Secondary|Area Under Curve (AUC) of Dexanabinol on Cycle 1 Day 1|Geometric mean AUC of Dexanabinol (0-infinity) on Cycle 1 Day 1.|Cycle 1- Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.|Concentrations of dexanabinol were not reported for some patients on Days 1 or 8 (including all patients in the 6 mg/kg arm) because the bioanalytical assay, in these instances, was not appropriately validated on the day of the assay. For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2670141|NCT01489826|Primary|Number of Patients Experiencing Dose Limiting Toxicity (DLT)|"Patients will be sequentially assigned to increasing doses of Dexanabinol, to establish the maximum tolerated dose (MTD) (highest dose it is safe to give patients) or alternatively the maximum administered dose (MAD).~3 patients will be enrolled to a cohort to assess each dose level. Dose escalation to a cohort of 3 new patients will occur when all patients in the previous cohort have completed the first cycle i.e. the first 3 doses followed by observation through to Day 22, and no DLT has occurred. Upon occurrence of the first DLT within a cohort, an additional 3 patients were to be added to that cohort. For a six patient cohort, all 6 patients were to have completed their first dexanabinol treatment cycle with no more than 1 DLT before dose escalation to the next cohort. If 2 or more DLTs occur in a cohort, the next lower dose level will be declared the MTD.~DLTs will be graded for severity based on the National Cancer Institute (NCI) Common Terminology Criteria version 4.03."|Each patient will be followed for 22 days|Patients will be sequentially assigned to increasing doses of Dexanabinol, to establish the MTD (highest dose it is safe to give patients) or alternatively the Maximum Administered Dose(MAD). DLT evaluation in 3 to 6 patients at end of 1 treatment cycle|||Number of patients with DLT|||Number
2670142|NCT01489670|Primary|Intraocular Pressure (IOP) at Week 12|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at the Final Visit at approximately Week 12. The lower the IOP values the greater the improvement.|Week 12|All participants with complete data available for IOP.|||mm Hg||Full Range|Median
2670143|NCT01489670|Secondary|Number of Patients Continuing Treatment After 12 Weeks|The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment?|Week 12|All participants with data available for this outcome measure.|||Participants|||Number
2670146|NCT01489670|Secondary|Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale|Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of participants in each category is reported.|Week 12|All participants with data available for this outcome measure.|||Participants|||Number
2670147|NCT01489670|Secondary|Physician Evaluation of Efficacy Using a 5-Point Scale|The physician evaluated efficacy using a 5-point scale (IOP lower than the target, Target IOP reached, IOP decreased but target not reached, IOP increased or No change). The number of participants in each category is reported.|Week 12|All participants with data available for this outcome measure.|||Participants|Participants||Number
2670148|NCT01489670|Primary|Intraocular Pressure (IOP) at Baseline|IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at Baseline.|Baseline|All participants with complete data available for IOP.|||mm Hg||Full Range|Median
2670149|NCT01489579|Secondary|The Proportion of Patients in Each Group Who Report Tobacco Abstinence During at the Three Months Follow-up Telephone Survey|The proportion of patients in each group who report tobacco abstinence during the follow-up telephone survey conducted three months following pharmacist contact|3 months||||Participants|||Count of Participants
2670150|NCT01489579|Secondary|The Proportion of Patients in Each Group Who Purchase Tobacco Cessation Medication Aids From KPCO Pharmacies Within Three Months Following Pharmacist Contact.|The proportion of patients in each group who purchase tobacco cessation medication aids from KPCO pharmacies within three months following pharmacist contact. Medications include nicotine replacement therapy, bupropion, and varenicline|3 months||||Participants|||Count of Participants
2670151|NCT01489579|Secondary|The Proportion of Patients Who Attend Any KPCO Tobacco Cessation Program(s)or Webinar(s) Within Three Months Following Contact.|The proportion of patients who attend any KPCO tobacco cessation program(s)or webinar(s) within three months following contact. Classes include Stop Smoking the Basics and Freedom from Cigarettes. Webinars include Break Free and Freedom from Tobacco|3 months|The proportion of patients who attend any KPCO tobacco cessation program(s)or webinar(s) within three months following contact. Classes include Stop Smoking the Basics and Freedom from Cigarettes. Webinars include Break Free and Freedom from Tobacco|||Participants|||Count of Participants
2670152|NCT01489579|Secondary|The Proportion of Patients in Each Group Who Participate in the Colorado Quitline (COQL) Within Three Months of Pharmacist Contact|Information on COQL participation was obtained from a prevention department within KPCO that tracks these data. Report was provided to capture who from study had participated in the COQL within 3 months of pharmacist contact.|3 months|Three control patients reported participation in the Colorado quitline|||Participants|||Count of Participants
2670153|NCT01489579|Primary|The Percentage of Self-reported Tobacco Cessation Attempts Between Groups|The proportion of patients in each group who report a tobacco cessation attempt during the follow-up telephone survey conducted three months following pharmacist contact|3 months|Reported not smoking at follow up survey|||participants|||Number
2670154|NCT01489527|Secondary|Percentage of Participants Who Seroconverted to HPV Types 31, 33, 45, or 58|The percent of women that seroconverted among those receiving qHPV vaccine compared to placebo vaccine recipients for HPV types 31, 33, 45, and 58, HPV types not directly targeted by the qHPV vaccine.|18 Months|All treated participants|||percentage of participants|||Number
2670155|NCT01489527|Secondary|Percentage of Participants Seroconverted to HPV Types 6, 11, 16, or 18|Percentage of participants who seroconverted to HPV types 6, 11, 16, or 18, following receipt of 3 doses of qHPV vaccine.|18 Months|Participants who were randomized to Gardasil and received all 3 doses of Gardasil|||percentage of participants|||Number
2670156|NCT01489527|Secondary|Percentage of Participants Who Were Seropositive by HPV Type|Percentage of participants who were seropositive to HPV at enrollment, by specific HPV type.|At Enrollment - 5 Month Enrollment Period|All treated participants|||percentage of participants|||Number
2670157|NCT01489527|Secondary|Study Compliance Rate|Percentage of participants to complete the 3-dose vaccination series and all 4 study visits.|18 Months|All treated participants|||percentage of participants|||Number
2670158|NCT01489527|Primary|Human Papillomavirus (HPV) Rate|HPV type distribution and prevalence of each HPV type at enrollment.|At Enrollment - 5 Month Enrollment Period|All treated participants|||participants|||Number
2670159|NCT01489358|Secondary|Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)|Neutralisation IC50 titre (strain OPY1)|24 weeks after the first vaccination|All subjects who received at least one vaccination|||titre||95% Confidence Interval|Geometric Mean
2670160|NCT01489358|Secondary|Chikungunya Antigen-specific Neutralizing Antibody Geometric Mean Titer (GMT)|Neutralisation IC50 titre (strain OPY1)|Pre-vaccination (Week 0)|All subjects who received at least one vaccination|||titre||95% Confidence Interval|Geometric Mean
2670161|NCT01489358|Secondary|Chikungunya Antigen-specific ELISA Geometric Mean Titer (GMT)|ELISA titer (strain 37997) For ELISA, week 0 values were used to background correct titres for subsequent weeks.|24 weeks after the first vaccination|All subjects who received at least one vaccination|||titre||95% Confidence Interval|Geometric Mean
2670162|NCT01489358|Primary|Number of Subjects Reporting 1 or More Unsolicited Adverse Event|"Unsolicited adverse events were recorded from enrollment through 28 days after the second vaccination; and from the third vaccination through 28 days after this vaccination.~Between and after the indicated time periods, through the last expected study visit (i.e., 24 weeks after the third vaccination), only SAEs and new chronic medical conditions were recorded. The number of unsolicited events reported for Group 3 here is lower than the total number of adverse events in the Adverse Event Module, which reports both solicited and unsolicited adverse events."|28 days after each vaccination|All subjects who received at least one vaccination|||participants|||Number
2670163|NCT01489358|Primary|Number of Subjects Reporting Serious Adverse Events|Serious adverse events were collected at each study visit from the time of first vaccination through the final study visit at 44 weeks after the first vaccination.|44 weeks after first vaccination|All subjects who received at least one vaccination|||participants|||Number
2670164|NCT01489358|Primary|Number of Subjects With an Any Abnormal Laboratory Result|Blood samples were collected for chemistry, CBC with differential, at baseline and weeks 2, 4, 6, 8, 20, 22, 24 and 44|44 weeks after first vaccination|All subjects who received at least one vaccination|||participants|||Number
2670165|NCT01489358|Primary|Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after any vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.|7 days after any vaccination|All subjects who received at least one vaccination|||participants|||Number
2670166|NCT01489358|Primary|Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after third vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.|7 days after the third vaccination|Number of subjects who received the third vaccination|||participants|||Number
2670167|NCT01489358|Primary|Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after second vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.|7 days after the second vaccination|All subjects who received the second vaccination|||participants|||Number
2670168|NCT01489358|Primary|Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all systemic symptoms is the number reporting one or more systemic symptom at any severity.|7 days after the first vaccination|All subjects who received the first vaccination|||participants|||Number
2670169|NCT01489358|Primary|Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after any vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.|7 days after any vaccination|Number of subjects who received at least one vaccination|||participants|||Number
2670170|NCT01489358|Primary|Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Third Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after third vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.|7 days after the third vaccination|Number of subjects who received the third vaccination|||participants|||Number
2670171|NCT01489358|Primary|Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Second Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after second vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.|7 days after the second vaccination|All subjects who received the second vaccination|||participants|||Number
2670172|NCT01489358|Primary|Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of First Vaccination|Subjects record the occurrence of solicited symptoms on a Memory Aid for 7 days after first vaccination and review the Memory Aid with clinic staff at follow a up visit. Subjects are counted once for each symptom if they indicated experiencing the symptom at any severity during the reporting period. The number reported for all local symptoms is the number reporting one or more local symptom at any severity.|7 days after the first vaccination|All subjects who received the first vaccination|||participants|||Number
2670173|NCT01489254|Primary|The Number of T1-Gadolinium Enhancing Lesions During Months 7-9|The primary endpoint was the total number of gadolinium enhancing lesions (i.e., the cumulative number of new and persisting gadolinium enhancing lesions) during months 7 through 9.|9 months|Full Analyis Set (FAS): all randomized subjects who received at least 1 dose of trial medication|||Number of lesions||95% Confidence Interval|Mean
2670174|NCT01489189|Secondary|Number of Eyes With Greater Than or Equal to 10 Letter Vision Loss||2-year|Participants that completed the 2-year visit.|||eyes|Eyes||Number
2670175|NCT01489189|Secondary|Number of Eyes Without Active or Regressed Neovascularization on Fundus Photography at 2-years||2-years|Eyes with baseline diabetic retinopathy level 61B or worse (active neovascularization). Last-observation-carried-forward was used for 23 eyes in the anti-VEGF+Deferred PRP group and 25 eyes in the Prompt PRP group missing photographs at 2 years if 1-year fundus photographs were available.|||eyes|Eyes||Number
2670176|NCT01489189|Secondary|Number of Eyes With Vitreous Hemorrhage||2-years||||Eyes|Eyes||Number
2670177|NCT01489189|Secondary|Development of Central DME With Vision Impairment by 2-years||2-years|Excludes that did not have central DME with vision impairment (20/32 or worse) at baseline.|||eyes|Eyes||Number
2670178|NCT01489189|Secondary|Mean Change in OCT Central Subfield Thickness From Baseline|All baseline and 2-year optical coherence tomography (OCT) scans were evaluated by the OCT reading center.|2-years|Eyes with optical coherence tomography (OCT) data at baseline and 2-years.|||µm|Eyes|95% Confidence Interval|Mean
2670179|NCT01489189|Secondary|Frequency of Vitrectomy||2-years||||eyes|Eyes||Number
2670260|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Severity of Overactive Bladder|Number of participants with responders of tolterodine to determine whether mild, moderate or severe is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2670180|NCT01489189|Secondary|Humphrey Visual Field Test Cumulative Score Change From Baseline|Visual fields, collected using the Humphrey Visual Field analyzer, measured the total point score (sum of retinal sensitivities of all points) tested on 30-2 and 60-4 patterns, which included the mid-peripheral and peripheral visual fields. A lower score indicates greater visual field loss.The cumulative score is the sum of all visual field sensitivity values for each of the four individual quadrants of the visual field (the quadrants are divided by the horizontal and vertical lines). The range can be from 0 to about 600 for the 30-2 test [for each quadrant], and from 0 to about 400 or 450 for the peripheral test.|2-years|Humphrey visual fields were obtained at a subset of sites. Fields with excessive false positive response, excessive false negative response, or excessive fixation loss were excluded from analysis. Twenty-two eyes in the anti-VEGF+deferred PRP group and 25 eyes in the prompt PRP group were excluded.|||decibels|Eyes|Inter-Quartile Range|Median
2670181|NCT01489189|Secondary|Number of Eyes With Greater Than or Equal to 10 Letter Vision Gain||2-years|Eyes with a baseline letter score of 78 or less (approximate Snellen equivalent 20/32 or worse) from participants that completed the 2-year visit.|||eyes|Eyes||Number
2670182|NCT01489189|Secondary|Mean Visual Acuity|Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.|2-years|Participants that completed the 2-year visit.|||letters|Eyes|Standard Deviation|Mean
2670183|NCT01489189|Primary|Mean Change in Visual Acuity From Baseline|Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.|2-years|Participants that completed the 2-year visit.|||letters|Eyes|95% Confidence Interval|Mean
2670184|NCT01489111|Secondary|Serious Adverse Events Reported During the Trial Period|Number of serious adverse event during the trial is presented. This includes events from the first trial related activity after the patient has signed the informed consent and until the end of trial (earliest at day 14).|During the trial (2-5 weeks)|Safety analysis set (SAS) included all patients exposed to trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated.|||serious adverse event|planned surgeries||Number
2670185|NCT01489111|Secondary|Adverse Events Reported During the Trial Period|Number of adverse event during the trial is presented. This includes events from the first trial related activity after the patient has signed the informed consent and until the end of trial (earliest at day 14).|During the trial (2-5 weeks)|Safety analysis set (SAS) included all patients exposed to trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated.|||adverse events|Planned surgeries||Number
2670186|NCT01489111|Secondary|Number of Days in Intensive Care|Mean number of days in the intensive care due to surgery during the trial is presented.|During the trial (2-5 weeks)|Full analysis set included all subjects exposed to the trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated.|||days|Surgeries|Standard Deviation|Mean
2670187|NCT01489111|Secondary|Length of Stay in the Hospital|Mean number of days stayed at the hospital during the trial.|During the trial (2-5 weeks)|Full analysis set included all subjects exposed to the trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated.|||days|Surgeries|Standard Deviation|Mean
2670188|NCT01489111|Secondary|Number of Transfusions During the Post-operative Period Days 1−6|Number of blood product transfusions (transfusion of red blood cells) during the post-surgery period, Days 1−6 is presented.|Post-operative period, days 1-6|Full analysis set included all subjects exposed to the trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated.|||blood transfusions|Surgeries||Number
2670189|NCT01489111|Secondary|Estimated Blood Loss During Surgery|The mean estimated blood loss following surgery is presented. Estimated blood loss (mL) was evaluated post surgery.|During surgery|Full analysis set included all subjects exposed to the trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated. 49 surgeries were evaluated in 35 participants.|||mL|Surgeries|Standard Deviation|Mean
2670190|NCT01489111|Secondary|Incidence Rate of Inhibitors Against Factor VIII (FVIII) (≥0.6 BU/mL)|Incidence rate of inhibitors is the number of newly developed inhibitors per surgery. Development of FVIII inhibitors was measured by a validated Nijmegen modified Bethesda assay. A positive inhibitor test was defined as ≥0.6 bethesda unit. Number of participants with inhibitors at the end of trial is presented.|during the trial (2-5 weeks)|Safety analysis set (SAS) included all patients exposed to trial drug (N8-GP).|||Participants|||Number
2670191|NCT01489111|Secondary|Average Consumption of N8-GP During the Post-operative Period Days 1-6|Average consumption of N8-GP during post operative period days 1-6 is presented. Analysis population: Full analysis set included all subjects exposed to the trial drug (N8-GP) and completed surgery.|During the post-operative period, days 1-6|Full analysis set included all subjects exposed to the trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated. 49 surgeries were evaluated in 35 participants.|||IU/kg|Surgeries|Standard Deviation|Mean
2670192|NCT01489111|Secondary|Haemostatic Effect of N8-GP During the Post-operative Period Days 7-14|"Haemostatic effect during post-operative period days 1-6 and days 7-14 was evaluated on a four-point response scale as 'none', 'moderate', 'good' and 'excellent'.~Excellent: Better than expected/predicted in this type of procedure. Good: As expected in this type of procedure. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.~None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required."|During the post-operative period, days 7-14|Full analysis set included all subjects exposed to the trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated. 2 surgeries with 2 bleeding episodes were evaluated in 35 participants.|||bleeding episodes|bleeding episodes||Number
2670275|NCT01488448|Primary|Length of Stay in the Study-LOS by Per Protocol Analysis|Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.|Time of first study treatment until time of discharge|Per protocol analysis (only includes participants who completed the study)|||Days||Inter-Quartile Range|Median
2670193|NCT01489111|Secondary|Haemostatic Effect of N8-GP During the Post-operative Period Days 1-6|"Haemostatic effect during post-operative period days 1-6 as evaluated on a four-point response scale as 'none', 'moderate', 'good' and 'excellent'.~Excellent: Better than expected/predicted in this type of procedure. Good: As expected in this type of procedure. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.~None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required."|During the post-operative period, days 1-6|Full analysis set included all subjects exposed to the trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated. 2 surgeries with 2 bleeding episodes were evaluated in 35 participants.|||bleeding episodes|bleeding episodes||Number
2670194|NCT01489111|Secondary|Average Consumption of N8-GP During Surgery|Average consumption of N8-GP, during surgery is presented. The time during surgery is defined from 'knife to skin' until 'last stitch'.|"During surgery, defined as the time from knife to skin until last stitch"|Full analysis set included all subjects exposed to the trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated. N8-GP was administered during 1 surgery for 1 participant.|||IU/kg|Surgeries||Number
2670195|NCT01489111|Primary|Haemostatic Effect During Surgery Evaluated by the Four-point Scale, Assessed by the Investigator/Surgeon at the Day of Surgery - Four-point Response Scale: Excellent, Good, Moderate or None|"Haemostatic effect during surgery was evaluated on a four-point response scale as 'none', 'moderate', 'good' and 'excellent'. This was assessed after completion of surgery (defined as last stitch).~Excellent: Better than expected/predicted in this type of procedure. Good: As expected in this type of procedure. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.~None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required."|Assessed by the Investigator/surgeon at the day of surgery|Full analysis set included all subjects exposed to the trial drug (N8-GP). 'Number Analyzed' = number of surgeries evaluated. 49 surgeries were evaluated in 35 participants.|||Surgeries|Surgeries||Number
2670196|NCT01489020|Secondary|Immunoglobulin Levels (IgG 4) Active Versus Placebo|Changes on immunoglobulin level determinations (IgG4) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.|Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)||||ng/mL||Standard Deviation|Mean
2670197|NCT01489020|Secondary|Immunoglobulin Levels (IgG Total) Active Versus Placebo|Changes on immunoglobulin level determinations (IgG) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.|Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)||||ng/mL||Standard Deviation|Mean
2670198|NCT01489020|Secondary|Immunoglobulin Levels (IgE Specific) Active Versus Placebo|Changes on immunoglobulin level determinations (specific IgE, IgG and IgG4) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.|Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)||||ng/mL||Standard Deviation|Mean
2670199|NCT01489020|Primary|Number and Seriousness of Both Local and Systemic Adverse Reactions|The primary end points were the number of ARs and the severity of local and systemic ARs (SARs) to SCIT administration. Proportions were compared between study arms. The tolerability of SCIT was evaluated by early and late local reactions (i.e., local swelling and redness) and systemic reactions after each injection (any symptoms from organs distant from the location of the injection). Reactions were classified depending on the severity and onset of the reaction, according to the EAACI classification (Alvarez-Cuesta 2006).|From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )||||adverse reactions number|||Number
2670200|NCT01488994|Secondary|Health Resource Use: Days Lost From School|The number of days lost from school per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26|Participants who missed days from school|||Days||Full Range|Median
2670201|NCT01488994|Secondary|Health Resource Use: Emergency Room Visits|The number of Emergency Room visits per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26||||Visits||Full Range|Median
2670202|NCT01488994|Secondary|Health Resource Use: Unscheduled Doctor's Office Visits|The number of unscheduled doctor's Office visits per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26|Participants who had unscheduled visits to a doctor's office|||Visits||Full Range|Median
2670203|NCT01488994|Secondary|Health Resource Use: Length of Hospitalization|The length of hospitalization per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26||||Days||Full Range|Median
2670204|NCT01488994|Secondary|Health Resource Use: Number of Hospitalizations|The number of hospitalizations per participant. Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants < 6 years of age; pediatric participants 6 to <12 years of age; Full Analysis Set.|Baseline (Pharmacokinetic [PK] assessment), Week 5, Week 13 and Week 26||||Hospitalizations||Full Range|Median
2670205|NCT01488994|Secondary|Health-related Quality of Life (HRQoL): Haemo-QoL, Change From Baseline in Total Score|The Haemo-QoL is a quality of life (QoL) assessment instrument for children and adolescents with haemophilia. As a hemophilia-specific instrument, this measure assesses very specific aspects of dealing with hemophilia. For the Haemo-QoL, higher scores indicate a worse quality of life. Scores on a scale range between 0 and 100.|Baseline and 6 months|Participants in the Full Analysis Set who had Haemo-QoL data for baseline and 6 months|||Scores on a scale||Standard Deviation|Mean
2670206|NCT01488994|Secondary|Health-related Quality of Life (HRQoL): PedsQL™ Change From Baseline in Total Score|"For this study, the PedsQL™ questionnaires for participants 2 to 7 years of age (parent-proxy versions for age groups 2-4 years and 5-7 years) and PedsQL™ Child version for participants 8 to 12 years of age were used.~The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. A 5-point score is used for each domain: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0 so that higher scores indicate better quality of life (QoL). The total score is the mean (average) of all scores from the 4 domains.~The change from baseline in total score is reported- a positive score indicates a better QoL compared to baseline and a negative score indicates a poorer QoL compared to baseline."|Baseline and 6 months|Participants in the Full Analysis Set who had PedsQL™ data for baseline and 6 months|||Scores on a scale||Standard Deviation|Mean
2670207|NCT01488994|Secondary|Safety: Number of Participants Who Developed Antibodies to Chinese Hamster Ovary (CHO) Proteins and Recombinant Furin (rFurin)|If more than 2-dilution increase as compared to pre-study level at screening and titers verified for specificity in the confirmatory assay.|Throughout study period (approximately 17 months)||||Participants|||Number
2670208|NCT01488994|Secondary|Safety: Number of Participants With Clinically Significant Changes in Routine Laboratory Parameters (Haematology and Clinical Chemistry), and Vital Signs|"Categories consist of Clinically Significant (CS) changes in haemaotology parameters, clinical chemistry parameters and vital signs.~Abbreviations in categories; Clin=clinical; params=parameters"|Throughout study period (approximately 17 months)||||Participants|||Number
2670209|NCT01488994|Secondary|Safety: Number of Participants With Thrombotic Events||Throughout study period (approximately 17 months)||||Participants|||Number
2670210|NCT01488994|Secondary|Safety: Number of Participants With Severe Allergic Reactions, e.g. Anaphylaxis||Throughout study period (approximately 17 months)||||Participants|||Number
2670211|NCT01488994|Secondary|Safety and Immunogenicity: Number of Participants Who Developed Total Binding Antibodies to Factor IX (FIX)|"If more than 2-dilution increase as compared to pre-study level at screening and titers verified for specificity in the confirmatory assay.~AB=antibodies in category for outcome measure data."|Throughout study period (approximately 17 months)||||Participants|||Number
2670212|NCT01488994|Secondary|Safety and Immunogenicity: Number of Participants Who Developed Inhibitory Antibodies to Factor IX (FIX)||Throughout study period (approximately 17 months)||||Participants|||Number
2670213|NCT01488994|Secondary|Consumption of BAX326: Weight-adjusted Consumption Per Event|Event includes prophylactic infusions of study product and infusions of study product for treatment of bleeding episodes (BEs).|Throughout study period (approximately 17 months)||||IU/kg||Standard Deviation|Mean
2670214|NCT01488994|Secondary|Consumption of BAX326: Weight-adjusted Consumption Per Year (Annualized)||Throughout study period (approximately 17 months)||||IU/kg per year||Standard Deviation|Mean
2670215|NCT01488994|Secondary|Consumption of BAX326: Weight-adjusted Consumption Per Month||Throughout study period (approximately 17 months)||||IU/kg per month||Standard Deviation|Mean
2670216|NCT01488994|Secondary|Consumption of BAX326: Number of Infusions Per Year||Throughout study period (approximately 17 months)||||Infusions per year||Standard Deviation|Mean
2670217|NCT01488994|Secondary|Consumption of BAX326: Number of Infusions Per Month||Throughout study period (approximately 17 months)||||Infusions per month||Standard Deviation|Mean
2670218|NCT01488994|Secondary|Hemostatic Efficacy: Prophylaxis: Annualized Bleeding Rate (ABR)|"The annualized bleeding rate (ABR) during prophylaxis was calculated only for participants who had adequate treatment time for bleeding rate assessment (i.e., more than 3 months of prophylaxis treatment). The observation period for prophylaxis was to be the time between the first and the last prophylactic infusions. The treatment period for surgery was to be excluded from the bleed rate calculation.~ABR calculated as (Number of bleeding episodes/observed treatment period in days) * 365.25."|Throughout study period (approximately 17 months)||||Bleeding episodes per year||Standard Deviation|Mean
2670219|NCT01488994|Secondary|Hemostatic Efficacy: Treatment of Bleeding Episodes: Overall Hemostatic Efficacy Rating at Resolution of Bleed|"Rating Scale for Treatment of bleeding episodes (4-point ordinal scale):~Excellent: Full relief of pain and cessation of objective signs of bleeding (eg, swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion required for the control of bleeding. Administration of further infusions to maintain hemostasis did not affect this scoring.~Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution.~Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after single infusion. Required more than 1 infusion for complete resolution.~None: No improvement or condition worsens."|Throughout study period (approximately 17 months)|Participants in the Full Analysis Set who had bleeding episodes|||Bleeding Episodes|Bleeding Episodes||Number
2670220|NCT01488994|Secondary|Hemostatic Efficacy: Treatment of Bleeding Episodes: Number of Infusions Per Bleeding Episode||Throughout study period (approximately 17 months)|Participants in the Full Analysis Set who had bleeding episodes|||Bleeding Episodes|||Number
2670221|NCT01488994|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR) Over Time|"IR calculated as follows: (FIX activity at post-infusion minus FIX activity at pre-infusion) divided by weight-adjusted dose. IR is determined at baseline (PK analysis), Week 5, Week 13 and Week 26 timepoints.~Number of participants contributing data (N) for this outcome measure is included in the category title in the order: pediatric participants > 6 years of age; pediatric participants 6 to <12 years of age; pharmacokinetic Full Analysis Set (PKFAS)."|Within 30 mins pre-infusion and 30 mins post-infusion at baseline, Week 5, Week 13 and Week 26.||||IU/dL : IU/kg||Standard Deviation|Mean
2670222|NCT01488994|Secondary|Pharmacokinetics (PK): Volume of Distribution at Steady State (Vss)|Computed as Clearance (CL) * Mean residence time (MRT)|Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:~Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"|||dL/kg||Standard Deviation|Mean
2670223|NCT01488994|Secondary|Pharmacokinetics (PK): Elimination Phase Half-life (T 1/2)|Calculated as log_e2/λ, where λ is the regression slope in the terminal phase of the least absolute deviations regression model|Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:~Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"|||hours (hr)||Standard Deviation|Mean
2670224|NCT01488994|Secondary|Pharmacokinetics (PK): Incremental Recovery (IR)|The rise in FIX activity in IU/dL per unit dose administered in IU/kg. Calculated as follows: (FIX activity at post-infusion minus FIX activity at pre-infusion) divided by weight-adjusted dose|Within 30 mins pre-infusion and 30 mins post-infusion||||IU/dL : IU/kg||Standard Deviation|Mean
2670225|NCT01488994|Secondary|Pharmacokinetics (PK): Factor IX (FIX) Clearance (CL)|Computed as the dose divided by total Area under the curve (AUC)|Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:~Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"|||dL/(kg*hr)||Standard Deviation|Mean
2670226|NCT01488994|Secondary|Pharmacokinetics (PK): Mean Residence Time (MRT)|Computed as total area under the first moment curve (total AUMC) divided by the total area under the concentration versus time curve (total AUC)|Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:~Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"|||hours (hr)||Standard Deviation|Mean
2670227|NCT01488994|Secondary|Pharmacokinetics (PK): Total Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity Post-infusion Per Dose (Total AUC/Dose)||Within 30 mins pre-infusion and 4 post-infusion timepoints. Refer to Population Description below for more details.|"All participants randomized to 2 groups:~Group 1 - BAX326 infusion in the morning PK timepoints: Pre-infusion and post-infusion at 15-30 minutes, then 7, 28 and 52 hours Group 2 - BAX326 infusion in the afternoon PK timepoints: Pre-infusion and post-infusion of 15-30 minutes, then 4, 24 and 69 hours"|||IU*hour (hr)/dL||Standard Deviation|Mean
2670228|NCT01488994|Secondary|Pharmacokinetics (PK): Total Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Post-infusion Per Dose (AUC 0-72h/Dose)||Within 30 mins pre-infusion and 4 post-infusion timepoints|On completion of the study, prospective changes to the planned statistical analysis were made not to analyze AUC 0-72h due to the different time points for the last PK blood sample. Only total AUC [i.e. AUC 0-infinity] was included in the PK analysis.||||||
2670229|NCT01488994|Primary|Adverse Events (AEs) Possibly or Probably Related to BAX326||Throughout study period (approximately 17 months)|Full analysis set|||AEs considered related to BAX326|||Number
2670230|NCT01488890|Secondary|Number of Participants Reporting Solicited Systemic Reactions (Fever, Headache, Malaise, Myalgia, Asthenia) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine|Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: >= 39.0°C; Headache, Malaise, Myalgia, and Asthenia: significant; prevents daily activity.|Within 14 days after any injection|Analysis was performed on Safety Analysis Set. Here, ‘Number analyzed’ = participants with available data for each specified category.|||Participants|||Count of Participants
2670231|NCT01488890|Secondary|Number of Participants Reporting Solicited Injection Site Reactions (Pain, Erythema, Swelling) Following Any Vaccination With CYD Dengue Vaccine (Administered With or Without Yellow Fever Vaccine) or Yellow Fever Vaccine|Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions: Pain: significant; prevents daily activity; Erythema and Swelling: >100 mm.|Within 7 days after any injection|Analysis was performed on Safety Analysis set which included participants who received at least one injection of CYD dengue vaccine or YF vaccine. Here, “Overall number of participants analyzed” signifies participants evaluable for this outcome measure.|||Participants|||Count of Participants
2670232|NCT01488890|Secondary|Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)|Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). FV non-immune participants were defined as participants with titer < 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer <10 (1/dilution) for YF virus (using sera with PRNT80 result).|Pre injection 1, 2, 3 and 28 days post injection 1, 2 and 3|Analysis was performed on Full Analysis Set. Here, ‘Overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘Number analyzed’ = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 4.|||percentage of participants|||Number
2670233|NCT01488890|Secondary|Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)|Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). FV immune participants at baseline were defined as participants with titer >= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer >=10 (1/dilution) for YF virus (sera with PRNT80 result).|Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3|Analysis was performed on Full Analysis Set. Here, Here, ‘Overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘Number analyzed’ = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 4.|||percentage of participants|||Number
2670350|NCT01487577|Secondary|Pharmacokinetic Analysis of MMF AUC to Evaluate MMF Dose Relationships to Drug Exposure.|Pharmacokinetic analysis includes, but is not limited to, area under the plasma concentration versus time curve (AUC).|100 days||||mcg*hr/mL||Full Range|Median
2670234|NCT01488890|Secondary|Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Non-Immune Participants)|GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. FV non-immune participants were defined as participants with titer < 10 (1/dilution) for all serotypes with parental dengue virus strains (sera tested by PRNT) and with titer <10 (1/dilution) for YF virus (using sera with PRNT80 result).|Pre-injection 1, 2, 3 and 28 days post-injection 1, 2 and 3|Analysis was performed on Full Analysis Set. Here, Here, ‘Overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘Number analyzed’ = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 4.|||Titer (1/dilution)||95% Confidence Interval|Geometric Mean
2670235|NCT01488890|Secondary|Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Each Injection With CYD Dengue Vaccine: Group 1, Group 2 and Group 3 (FV Immune Participants)|GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT. FV immune participants were defined as participants with titer >= 10 (1/dilution) for at least 1 serotype with parental dengue virus strain (sera tested by PRNT) or with titer >= 10 (1/dilution) for YF virus (sera with PRNT80 result).|Pre Injection 1, 2 and 3 and 28 days post injection 1, 2 and 3|Analysis was performed on Full Analysis Set. Here, Here, ‘Overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘Number analyzed’ = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 4.|||Titer (1/dilution)||95% Confidence Interval|Geometric Mean
2670236|NCT01488890|Secondary|Percentage of YF Non-Immune Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1: Group 1 and Group 2 (Pooled) and Group 3|Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution). Groups 1 and 2 data was reported as pooled data. YF-non immune participants were defined as participants with YF baseline titer dengue plaque reduction neutralization test-80 (PRNT80) <10 (1/dilution).|Pre-injection 1 and 28 days post-injection 1|Analysis was performed on Full Analysis Set. Here, “Overall number of participants analyzed = participants evaluable for this outcome measure” and ‘Number analyzed’ = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 4.|||percentage of participants|||Number
2670237|NCT01488890|Secondary|Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 In YF Non-Immune Participants: Group 1 and Group 2 (Pooled) and Group 3|GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test-50 (PRNT50). Groups 1 and 2 data was reported as pooled data. YF-non immune participants were defined as participants with YF baseline titer PRNT80 < 10 (1/dilution).|Pre-injection 1 and 28 days post-injection 1|Analysis was performed on Full Analysis Set. Here, “Overall number of participants analyzed = participants evaluable for this outcome measure” and ‘Number analyzed’ = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 4.|||Titer (1/dilution)||95% Confidence Interval|Geometric Mean
2670238|NCT01488890|Secondary|Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2|Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution).|Pre-injection 1 and 2 and 28 days post-injection 1 and 2|Analysis was performed on Full Analysis Set. Here, ‘Number analyzed’ = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3 and 4.|||Percentage of participants|||Number
2670239|NCT01488890|Secondary|Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 1 and Dose 2: Group 1 and Group 2|GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue PRNT.|Pre-injection 1 and 2 and 28 days post-injection 1 and 2|Analysis was performed on Full Analysis Set. Here, ‘Number analyzed’ = participants with available data for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Group 3 and 4.|||Titer (1/dilution)||95% Confidence Interval|Geometric Mean
2670240|NCT01488890|Primary|Percentage of Participants With Seropositivity Against Each Dengue Virus Serotype Following Injection With CYD Dengue Vaccine Dose 3: Group 1 and Group 2|Seropositivity against each dengue virus serotypes (parental strains) was assessed using the dengue PRNT. Seropositive participants were defined as the participants with neutralizing antibody titer >=10 (1/dilution).|Pre-injection 1, 28 days and 6 months post-injection 3|Analysis was performed on Full Analysis Set. Here, ‘Number analyzed’ = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 3 and 4.|||percentage of participants|||Number
2670241|NCT01488890|Primary|Geometric Mean Titers (GMTs) of Antibodies Against Each Dengue Virus Serotype Following Injection (Inj.) With CYD Dengue Vaccine Dose 3: Group 1 and Group 2|GMTs of antibodies against each dengue virus serotype (parental strain) was assessed using the dengue plaque reduction neutralization test (PRNT).|Pre-injection 1, 28 days and 6 months post-injection 3|Full Analysis Set included participants who received at least 1 Inj. of CYD dengue or/ YF vaccine, had at least 1 blood sample drawn and valid post-Inj. serology result. Here, ‘Number analyzed’ = participants with available data for each specified category. Data for this outcome measure was not planned to be collected, analyzed for Group 3 and 4.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2670242|NCT01488877|Secondary|Change From Baseline in Sitting Pulse Rate at Day 15|Sitting pulse rate was measured in the brachial/radial artery for at least 30 seconds. A total of 3 measurements were performed; average of triplicate pulse rate values collected pre-dose on Day 1 served as baseline.|Day 1 (Baseline), 15|Safety analysis set included all participants who received at least 1 dose of study medication.|||beats per minute (bpm)||Standard Deviation|Mean
2670351|NCT01487577|Secondary|Number of Participants in Overall Survival.||1 year||||participants|||Number
2670352|NCT01487577|Secondary|Number of Participants Who Experienced Nonrelapse Mortality.||1 year||||participants|||Number
2670243|NCT01488877|Secondary|Change From Baseline in Sitting Systolic and Diastolic Blood Pressure at Day 15|Systolic blood pressure (BP): BP when heart is contracting; maximum arterial pressure during contraction of left ventricle of heart. Diastolic blood pressure: BP when heart is relaxing; minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed; average of triplicate BP values collected pre-dose on Day 1 served as baseline. The same arm and same sized cuff (properly sized and calibrated) was used throughout the study, after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements.|Day 1 (Baseline), 15|Safety analysis set included all participants who received at least 1 dose of study medication.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2670244|NCT01488877|Secondary|Plasma Pharmacokinetic (PK) Parameters|PK parameters were to be evaluated at Day 1 and Day 14 (steady state). Maximum observed plasma concentration (Cmax), time to reach maximum observed plasma concentration (Tmax), area under the curve from time zero to end of dosing interval (AUCtau) were to be evaluated at both Day 1 and Day 14 (steady state). Minimum observed plasma trough concentration (Cmin), average plasma concentration (Cavg), apparent oral clearance (CL/F), apparent volume of distribution (Vz/F) were to be evaluated only at Day 14 (steady state). Observed accumulation ratio (Rac) was also planned to be analyzed.|0 (pre-dose), 2, 4, 6, 8, 10, 14, 24 hours post-dose on Day 1, 14|Data for all pre-specified PK parameters were not analyzed because a decision was made to prematurely terminate the study.||||||
2670245|NCT01488877|Primary|Number of Participants With Confirmed and Severe Hyperkalemia|Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated. Confirmed hyperkalemia is defined as serum potassium level greater than (>) upper limit of normal (ULN) of 5.4 mEq/L. Severe hyperkalemia is defined as serum potassium level >= 6.0 mEq/L. Number of participants with at least 1 confirmed or severe hyperkalemia is reported.|Baseline up to Day 15|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2670246|NCT01488877|Primary|Change From Baseline in Serum Potassium at Day 15|Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 15 value calculated was average of 0 hours (immediately pre-dose) measurement on Day 14 and measurement obtained prior to discharge on Day 15. Change from baseline values were presented under time point of Day 15.|Baseline, Day 14, 15|Safety analysis set included all participants who received at least 1 dose of study medication.|||mEq/L||Full Range|Median
2670247|NCT01488877|Primary|Change From Baseline in Serum Potassium at Day 8|Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 8 value calculated was average of 0 hours (immediately pre-dose) measurements on Day 7 and 8. Change from baseline values were presented under time point of Day 8.|Baseline, Day 7, 8|Safety analysis set included all participants who received at least 1 dose of study medication.|||milliequivalent/liter (mEq/L)||Full Range|Median
2670248|NCT01488708|Secondary|Change in Anti-double-stranded Deoxyribonucleic Acid Level||Baseline, 4 years|Zero participants analyzed. Data was not collected for analysis.||||||
2670249|NCT01488708|Secondary|Proportion of Participants With Improvement in Lupus Quality of Life||4 years|Zero participants analyzed. Data was not collected for analysis.||||||
2670250|NCT01488708|Secondary|Occurrence of New Severe SLE Flares||Baseline through 4 years|Zero participants analyzed. Data was not collected for analysis.||||||
2670251|NCT01488708|Secondary|Change in SLE Disease Activity Index||Baseline, 4 years|Zero participants analyzed. Data was not collected for analysis.||||||
2670252|NCT01488708|Secondary|Proportion of Participants With a Reduction in Steroid Dose||Baseline through 4 years|Zero participants analyzed. Data was not collected for analysis.||||||
2670253|NCT01488708|Secondary|Proportion of Participants With a Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response||Week 48|Zero participants analyzed. Data was not collected for analysis.||||||
2670254|NCT01488708|Primary|Percentage of Participants With Adverse Events (AEs)|A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.|Baseline through 4 years|All participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2670255|NCT01488578|Primary|Confirmation of Frequent Treatment Related Adverse Events (TRAEs) at the End of Observation Period.|The Treatment Related Adverse Events (TRAEs) at the end of observation period with an incidence of 1% or higher.|12 week|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol.|||events|||Number
2670256|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Previous Treatment|Number of participants with response to tolterodine to determine whether with or without previous treatment is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2670257|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinary Incontinence Episodes Per Day|Number of participants with responders of tolterodine to determine the Number of urinary incontinence episodes per day is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2670258|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Number of Urinations Per Day (During Sleep)|Number of participants with responders of tolterodine to determine the Number of urinations per day (during sleep) is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2670259|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Urinary Urgency|Number of participants with responders of tolterodine to determine whether with or without Urinary urgency is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2670353|NCT01487577|Secondary|Number of Participants Who Experienced Relapse.||1 year||||participants|||Number
2670354|NCT01487577|Secondary|Number of Participants With Neutrophil and Platelet Engraftment.|Neutrophil and platelet engraftment definitions as defined by the CIBMTR Data Management Manual.|100 days||||participants|||Number
2670261|NCT01488578|Secondary|Number of Unlisted Treatment Related Adverse Events (TRAEs)Reported in at Least 5 Participants|All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.|12 week|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol.|||events|||Number
2670262|NCT01488578|Secondary|Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Tolterodine - Comorbidity of Prostatic Hypertrophy|Number of participants with Treatment Related Adverse Events (TRAEs) of tolterodine to determine whether with or without comorbidity of benign prostatic hypertrophy (BPH) is significant risk factor.|12 week|The safety analysis population consists of the cases that satisfy the participants conditions and in whom administration of this drug was confirmed.|||participants|||Number
2670263|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Age|Number of participants with responders of tolterodine to determine whether <65 years or >=65 years is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2670264|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Complications|Number of participants with responders of tolterodine to determine whether with or without complications is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2670265|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Gender|Number of participants with responders of tolterodine to determine whether male or female is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2670266|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Non-drug Therapies|Number of participants with responders of tolterodine to determine whether with or without Non-drug therapies is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2670267|NCT01488578|Primary|Number of Participants With an Investigator's Assessment of Clinical Outcome at End of the Study.|Clinical overall effectiveness was evaluated by investigators based on clinical symptoms, etc, at the end of observation period.|12 week|"The efficacy analysis population included all subjects from the safety analysis population in whom the efficacy of this drug could be evaluated.~Number of participants evaluable for which was evaluated effect."|||participants|||Number
2670268|NCT01488578|Primary|"Number of Participants Which Was Evaluated as Degree of Satisfaction."|Participant satisfaction was evaluated by investigators based on questioning the participants at the end of observation period using choices: Satisfied, Dissatisfied, Neither of the above.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2670269|NCT01488578|Secondary|Risk Factors for the Proportion of Responders of Tolterodine-Concomitant Drugs|Number of participants with responders of tolterodine to determine whether with or without concomitant drugs is significant risk factor.|12 week|The efficacy analysis population consists of the evaluable cases in accordance with the analysis plan (cases judged to have been evaluated appropriately).|||participants|||Number
2670270|NCT01488578|Primary|Confirmation of the Incidence of All Treatment Related Adverse Events (TRAEs).|All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.|12 weeks|Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of Detrusitol.|||participants|||Number
2670271|NCT01488487|Secondary|Objective Response Rate (ORR)|"ORR is the rate of complete responses (CRs) + partial responses (PRs) as determined by RECIST (v1.1) and modified HCC RECIST criteria. Responses defined as follows:~CR: disappearance of all clinical/radiological evidence of tumor including any intratumoral arterial enhancement in all target lesions.~Partial Response (PR): at least a 30% decrease in the sum of diameters of viable (contrast enhancement in the arterial phase) target lesions, referencing the baseline sum.~Stable Disease (SD): any cases that do not qualify for either partial response or progressive disease.~Progressive Disease (PD): an increase of at least 20% in the sum of the diameters of viable target lesions, referencing the nadir sum, and/or the appearance of one or more new lesions. A new hepatic nodule signals PD when the longest diameter is at least 10 mm and the nodule shows the typical vascular pattern of HCC on dynamic imaging or if at least 1-cm interval growth is seen in subsequent scans."|3.5 years|Two patients were not evaluable; one due to death prior to radiographic evaluation (death clinically attributed to progressive disease) and the other due to early termination of treatment due to intolerance.|||percentage of participants|||Number
2670272|NCT01488487|Secondary|Overall Survival (OS)|Overall survival is defined as the time from study enrollment until death.|3.5 years||||months||95% Confidence Interval|Median
2670273|NCT01488487|Secondary|Number of Individuals Experiencing Toxicity|Safety determinations are based on the rate of drug-related adverse events (AEs) reported based upon the toxicity as measured by the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).|3.5 years||||participants|||Number
2670274|NCT01488487|Primary|Time to Progression (TTP)|Time to progression is defined as the time from study enrollment until radiological progression in a previously embolized lobe, development of new lesions in an untreated lobe, or evidence of extrahepatic progression (based on modified Hepatocellular Carcinoma (HCC) Response Evaluation Criteria In Solid Tumors (RECIST) criteria). Patients will be followed until death. Patients that die of causes unrelated to the study drug without evidence of progression will be censored.|3.5 years||||months||95% Confidence Interval|Median
2670276|NCT01488448|Post-Hoc|LOS Analysis for Patients Whose Study Entry Respiratory Distress Assessment Instrument (RDAI) Was Greater Than or Equal to 4 or Who Had Hypoxia <92%||through hospitalization/while receiving study medication, average 2-3 days|Subgroup of patients who had a study entry Respiratory Distress Assessment Instrument (RDAI) of greater than or equal to 4 points OR hypoxia <92% on admission|||days||Inter-Quartile Range|Median
2670277|NCT01488448|Post-Hoc|LOS Subgroup Analysis of Patients With a History of Prematurity||through hospitalization/while receiving study medication, average 2-3 days|Patients who reported a history of prematurity/whose Gestational age was <37 weeks|||days||Inter-Quartile Range|Median
2670278|NCT01488448|Post-Hoc|LOS in Patients With a History of Previous Wheeze||through hospitalization/while receiving study medication, average 2-3 days|Subgroup of the study population who reported a history of wheezing prior to this admission|||days||Inter-Quartile Range|Median
2670279|NCT01488448|Post-Hoc|LOS in Subgroup of Patients With Testing Positive for Respiratory Syncitial Virus (RSV+)||through hospitalization/while receiving study medication, average 2-3 days|This is the population in the study whose RSV testing was positive.|||days||Inter-Quartile Range|Median
2670280|NCT01488448|Secondary|Total Adverse Events|Clinical worsening events (defined prior) + 7 day readmissions|Time of enrollment in the study through 1 week after hospital discharge||||adverse events|||Number
2670281|NCT01488448|Secondary|Clinical Worsening|transfer to the Pediatric Intensive Care Unit (PICU) (including withdrawn from the study for bronchodilator administration who were then transferred to the PICU), or Respiratory Distress Assessment Instrument (RDAI) increase of 4 or more points within 30 minutes of a study treatment|though hospitalization/time period receiving study treatment, average 2-3 days|all patients enrolled in the study were analyzed for events related to clinical worsening|||participants|||Number
2670282|NCT01488448|Secondary|Readmission for Bronchiolitis Within 7 Days of Discharge|Phone call at 7 days to assess for readmission to any hospital|within 7 days of hospital discharge|This population is those who completed the study.|||participants|||Number
2670283|NCT01488448|Primary|Length of Stay in the Study-LOS--Intention to Treat Analysis|Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.|Time of first study treatment until time of discharge|Intention to Treat Analysis|||Days||Inter-Quartile Range|Median
2670284|NCT01488409|Secondary|Change From Baseline in Lipid Profile at 6-months|Change in direct low density lipoprotein (LDL) cholesterol is given|Change from Baseline to 6-months|all available data used|||mg/dL||Standard Deviation|Mean
2670285|NCT01488409|Secondary|Change From Baseline in Intramyocellular Lipid Content at 6-months|Change in tibialis intramyocellular lipid (IMCL) normalized to creatinine is given.|Change from Baseline to 6-months|all available data used|||ratio of IMCL peak to Creatinine peak||Standard Deviation|Mean
2670286|NCT01488409|Secondary|Change From Baseline in Mitochondrial Density at 6 Months|Muscle tissue obtained from biopsy will be used to assess mitochondrial number and morphology by microscopes at Baseline and at 6-months. The change in mitochondrial density from 6 months to baseline is given.|Change from Baseline to 6-months|all available data used|||percentage of total muscle fiber area||Standard Deviation|Mean
2670287|NCT01488409|Secondary|Change From Baseline in Insulin Sensitivity at 6-months|Change in insulin resistance assessed by hyperinsulinemic-euglycemic clamp study at Baseline and at 6-months. Change in insulin-stimulated glucose uptake (M) during 40 mU/m2/min insulin clamp is given.|Change from Baseline to 6-months visit|all available data used|||mg/kg/min||Standard Deviation|Mean
2670288|NCT01488409|Primary|Change From Baseline in Phosphocreatine Recovery (ViPCr) at 6-months|The rate of recovery of phosphocreatine concentration after depletion by exercise is considered a measurement of mitochondrial function. Change in phosphocreatine recovery from baseline to 6 months will therefore give a measurement of change in mitochondrial function. ViPCR is given -- a higher value indicates better mitochondrial function.|Change from Baseline to 6-months Visit|all available data used|||mM/s||Standard Deviation|Mean
2670289|NCT01488370|Secondary|Successful Intubation After Four Laryngoscopy Attempts||Through endotracheal intubation during induction of general anesthesia, an average of 10 minutes||||Participants|||Count of Participants
2670290|NCT01488370|Secondary|Successful Intubation After Three Laryngoscopy Attempts||Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.||||Participants|||Count of Participants
2670291|NCT01488370|Secondary|Successful Intubation After Two Laryngoscopy Attempts||Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.||||Participants|||Count of Participants
2670292|NCT01488370|Secondary|Successful Intubation After One Laryngoscopy Attempt|Other secondary outcome measures will be the use of external laryngeal manipulation to improve glottic view, tissue trauma and type,and method of rescue if initial intubation attempt proves unsuccessful.|Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia.||||Participants|||Count of Participants
2670293|NCT01488370|Primary|Measurement of Time to Intubation Will Begin at the Time of Mouth Opening and End With the Removal of the Tip of the Laryngoscope Blade From the Patient's Mouth After Successful Endotracheal Intubation.||Less than one day, representing the day of surgery and period of endotracheal intubation during induction of general anesthesia|Time to successful tracheal intubation|||Seconds||95% Confidence Interval|Mean
2670294|NCT01488318|Secondary|Overall Survival (OS)|From date of entry into the study until the date of death from any cause, assessed up to 60 months.|Up to 60 months||||months||90% Confidence Interval|Median
2670295|NCT01488318|Secondary|Progression-free Survival (PFS)||Up to 36 months||||months||90% Confidence Interval|Median
2670296|NCT01488318|Primary|Response to Treatment|Response of evaluable patients to treatment, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.|Up to 36 months|Patients that received Cetuximab dosed at 250 mg/m^2/week and Dasatinib 150 mg daily who were evaluable for response.|||participants|||Number
2670393|NCT01486966|Secondary|Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment||Week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.|||percentage (%) of subjects|||Number
2670297|NCT01488318|Primary|Overall Response Rate (ORR)|Number of patients experiencing a Complete Response (CR) + Partial Response (PR) to study treatment / Total number of evaluable patients, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.|Up to 36 months|Patients that received Cetuximab dosed at 250 mg/m^2/week and Dasatinib 150 mg daily who were evaluable for response.|||percentage of participants|||Number
2670298|NCT01488279|Secondary|Change in Insulin Secretion (AIRg or Acute Insulinogenic Response to Glucose)|We measured the change in insulin secretion (AIRg or acute insulinogenic response to glucose) during the MTT and compared the insulin secretion on the DPP4 inhibitor (sitagliptin) compared to placebo. We had expected the AIRg to be greater with DPP4i compared to placebo.|measured twice: on day #8 (after 7 days of study drug and 1 day of IVGTT) of sitagliptin during MTT, then after 4 week washout, measured again on day #8 (after 7 days of study drug + 1 day of IVGTT) of dex + placebo during MTT||||pmol/l||Standard Error|Least Squares Mean
2670299|NCT01488279|Secondary|Change in Glucose Response|Change in glucose response during the MTT. This was the Si (insulin sensitivity). We sought to determine whether there was an improvement in the glucose response after a meal on the DPP4i compared to placebo in the face of steroid (dexamethasone).|measured on day #9 (after 7 days of study drug and 1 day of IVGTT) of sitagliptin during MTT, then after 4 week washout, measured again on day #9 (after 7 days of study drug + 1 day of IVGTT) of dex + placebo during MTT||||response x 10000 / minute / microUnit/ml||Standard Error|Least Squares Mean
2670300|NCT01488279|Secondary|Change in Active GLP-1|As with GIP, we had planned to measure the difference or change in active GLP-1 in response to the MTT between the 2 study drug periods: on sitagliptin versus on placebo. We had hypothesized that GIP and GLP-1 would be elevated while on the DPP4 inhibitor compared to placebo as this is the mechanism of action of the drug sitagliptin. When other measures were negative, we elected not to pursue this due to time and cost.|Active GLP-1 would have been measured during MTT after 1 week of dex + sitagliptin and again after 1 week of dex + placebo, but we did not measure active GLP-1|We did not measure GLP-1||||||
2670301|NCT01488279|Secondary|Change in Active GIP|We had planned to measure the difference or change in active GIP in response to the MTT between the 2 study drug periods: on sitagliptin versus on placebo. However, when other measures were negative, we opted not to pursue this lab assay for cost and time. We did not perform measures of GIP.|Active GIP would have been measured during MTT after 1 week of dex + sitagliptin and again after 1 week of dex + placebo, but we did not measure active GIP|We did not measure GIP||||||
2670302|NCT01488279|Primary|Insulin Sensitivity|Insulin Sensitivity measured at the end of each treatment period. The primary outcome variable was the difference in the disposition index (DI) determined as the product of the acute insulin response to glucose (AIRg) x the insulin sensitivity index (SI) in subjects during IVGTT on the 8th day (after 7 days) of on dex + placebo, then a after a washout of approximately 4 weeks, participants crossed over to dex + sitagliptin 100 mg x 7 days. Subjects were randomized to order of medication. The primary analyses will be an ANCOVA, including baseline responses as a covariate.|Measured on day #8 (after 8 days of sitagliptin or placebo) followed by a 4 week washout then measured again on day #8 (after 8 days of crossover treatment).|Subjects were randomized to the order to study medication (dex + sitagliptin vs dex + placebo) by the pharmacy in order to keep double blinding|||ratio without units||Standard Error|Mean
2670303|NCT01488188|Secondary|Cell Mediated Immune Responses|Interferon gamma production in peripheral blood monocyte (PBMC) after in vitro re-stimulation with influenza virus antigen at 21 days after vaccination.|21 days after vaccination||||pg/ml||Full Range|Median
2670304|NCT01488188|Secondary|Salivary IgA|Salivary Flu-specific IgA titer at Days 21 after vaccination|21 days after vaccination||||Titer||Full Range|Median
2670305|NCT01488188|Secondary|Blood Immunoglobulin G (IgG) and Immunoglobulin A (IgA)-Antibody Secreting Cell Number to Flu Virus|Flu virus-specific IgG- and IgA -antibody secreting cells per ml of blood at 7 days after vaccination|7 days after vaccination||||cells/ml||Full Range|Median
2670306|NCT01488188|Primary|Passive Haemagglutination Inhibition Titer.|Passive haemagglutination inhibition titer of serum at 21 days after vaccination.|21 days after vaccination||||Titer||Full Range|Median
2670307|NCT01488097|Secondary|Changes From Baseline In Hs-CRP|Changes from Baseline to Week 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS for high sensitivity C-reactive protein (hs-CRP). Baseline values were defined as the last measurement prior to the first infusion of sebelipase alfa in Study LAL-CL04.|Baseline, Week 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS|Participants in the FAS for whom hs-CRP data were available at both Baseline and the indicated post-treatment time point. The FAS included all participants who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.|||mg/L||Standard Deviation|Mean
2670308|NCT01488097|Secondary|Changes From Baseline In Serum Ferritin|Changes from Baseline to Week 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS for serum ferritin. Baseline values were defined as the last measurement prior to the first infusion of sebelipase alfa in Study LAL-CL04.|Baseline, Week 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS|Participants in the FAS for whom serum ferritin data were available at both Baseline and the indicated post-treatment time point. The FAS included all participants who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.|||microgram (µg)/L||Standard Deviation|Mean
2670309|NCT01488097|Secondary|Changes From Baseline In Serum Lipids|Lipid changes from Baseline to Week 10 or 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS were measured in serum for total cholesterol (Total-C), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), and triglycerides (TG). Baseline values were defined as the last measurement prior to the first infusion of sebelipase alfa in Study LAL-CL04.|Baseline, Week 10 or 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS|Participants in the FAS for whom lipid data were available at both Baseline and the indicated post-treatment time point. The FAS included all participants who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.|||mg/dL||Standard Deviation|Mean
2670355|NCT01487577|Primary|Number of Participants With Acute Grade II-IV GVHD, Acute Grade III-IV GVHD, and Chronic GVHD.|Acute GVHD will be graded according to the Modified Glucksberg Staging Criteria. Chronic GVHD will be graded according to NIH Chronic GVHD Consensus Guidelines.|1 year||||participants|||Number
2670310|NCT01488097|Secondary|Changes From Baseline In GGT And ALP|Changes from Baseline to Week 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS for gamma glutamyltransferase (GGT) and alkaline phosphatase (ALP). Baseline values were defined as the last measurement prior to the first infusion of sebelipase alfa in Study LAL-CL04.|Baseline, Week 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS|Participants in the FAS for whom GGT and ALP data were available at both Baseline and the indicated post-treatment time point. The FAS included all participants who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.|||U/L||Standard Deviation|Mean
2670311|NCT01488097|Secondary|Changes From Baseline In Liver Fat Content|Changes in liver fat content from Baseline to Week 10 or 12, Week 24, Week 52, Week 104, Week 156, Week 208, and Week 260, as assessed by multi-echo gradient-echo MRI. Baseline values were defined as the last measurement prior to the first infusion of sebelipase alfa in Study LAL-CL04.|Baseline, Week 10 or 12, Week 24, Week 52, Week 104, Week 156, Week 208, and Week 260|Participants in the FAS for whom liver fat content data were available at both Baseline and the indicated post-treatment time point. The FAS included all participants who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.|||percentage fat fraction||Standard Deviation|Mean
2670312|NCT01488097|Secondary|Changes From Baseline In Liver Volume|Changes in liver volume from Baseline to Week 10 or 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS was assessed by magnetic resonance imaging (MRI). Baseline values were defined as the last measurement prior to the first infusion of sebelipase alfa in Study LAL-CL04. Liver volume was expressed as multiples of normal (MN), where normal is defined as 2.5% of body weight.|Baseline, Week 10 or 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS|Participants in the FAS for whom liver volume data were available at both Baseline and the indicated post-treatment time point. The FAS included all participants who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.|||Multiples of Normal (MN)||Standard Deviation|Mean
2670313|NCT01488097|Secondary|Changes From Baseline In ALT And AST|Changes from Baseline to Week 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS for alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Baseline values were defined as the last measurement prior to the first infusion of sebelipase alfa in Study LAL-CL04.|Baseline, Week 12, Week 24, Week 52, Week 104, Week 156, Week 208, Week 260, and EOS|Participants in the Full Analysis Set (FAS) for whom ALT and AST data were available at both Baseline and the indicated post-treatment time point. The FAS included all participants who received at least 1 complete infusion of sebelipase alfa in this study and who had at least 1 post-treatment measurement in this study.|||units (U)/liter (L)||Standard Deviation|Mean
2670314|NCT01488097|Primary|Number Of Participants Reporting TEAEs And IARs|Safety and tolerability of sebelipase alfa was primarily assessed by monitoring the number of participants reporting treatment-emergent adverse events (TEAEs), including serious adverse events, and infusion-associated reactions (IARs). The number of participants who discontinued from the study due to a TEAE is also presented. An IAR was defined as any adverse event that occurred during the 2-hour infusion or within 4 hours after the end of the infusion and was assessed by the investigator as at least possibly related to study drug. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. TEAEs that occurred after the first dose administration at Week 1 through the End of Study (EOS) are presented. End of study was 30 days (+ 7 days) after the last dose of study drug (at Week 260).|From after first dose administration post-Baseline through EOS during study LAL-CL04|Safety Analysis Set: All participants who received any amount of study drug in the extension study.|||Participants|||Count of Participants
2670315|NCT01488071|Secondary|Change From Baseline in SDS Total Score at Week 12||Baseline and Week 12|FAS|||units on a scale||Standard Error|Mean
2670316|NCT01488071|Secondary|Change From Baseline in SDS Total Score at Week 8|The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|FAS|||units on a scale||Standard Error|Mean
2670317|NCT01488071|Secondary|Proportion of Patients Who Are in Remission at Week 12 (Remission is Defined as a MADRS Total Score <=10)||Week 12|FAS, LOCF|||percentage of participants|||Number
2670318|NCT01488071|Secondary|Proportion of Patients Who Are in Remission at Week 8 (Remission is Defined as a MADRS Total Score <=10)||Week 8|FAS, LOCF|||percentage of participants|||Number
2670319|NCT01488071|Secondary|Proportion of Patients Who Respond at Week 12 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Baseline and Week 12|FAS, LOCF|||percentage of participants|||Number
2670320|NCT01488071|Secondary|Proportion of Patients Who Respond at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)||Baseline and Week 8|FAS, last observation carried forward (LOCF)|||percentage of participants|||Number
2670321|NCT01488071|Secondary|Change in Clinical Status Using CGI-I Score at Week 12||Week 12|FAS|||units on a scale||Standard Error|Mean
2670322|NCT01488071|Secondary|Change in Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment. Higher score = more affected.|Week 8|FAS|||units on a scale||Standard Error|Mean
2670323|NCT01488071|Secondary|Change From Baseline in CGI-S Score at Week 12||Baseline and Week 12|FAS|||units on a scale||Standard Error|Mean
2670356|NCT01487577|Primary|Number of Participants With Grade ≥3 Toxicities Scored According to the CTCAE Version 4.0.||100 days||||participants|||Number
2670357|NCT01487525|Secondary|Knee Pain|Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire Pain Sub-Scale (0-100); larger absolute values represent less pain; a positive % changes indicates a reduction in pain|0, 6 weeks||||Percent change||Standard Deviation|Mean
2670324|NCT01488071|Secondary|Change From Baseline in CGI-S Score at Week 8|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating. Higher score indicates that the subject is more ill, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|FAS|||units on a scale||Standard Error|Mean
2670325|NCT01488071|Secondary|Change From Baseline in HAM-A Total Score at Week 12||Baseline and Week 12|FAS|||units on a scale||Standard Error|Mean
2670326|NCT01488071|Secondary|Change From Baseline in HAM-A Total Score at Week 8|The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56; higher score indicates greater anxiety, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|FAS|||units on a scale||Standard Error|Mean
2670327|NCT01488071|Secondary|Change From Baseline in MADRS Total Score at Week 12||Baseline and Week 12|FAS|||units on a scale||Standard Error|Mean
2670328|NCT01488071|Primary|Change From Baseline in MADRS Total Score at Week 8|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.|Baseline and Week 8|full-analysis set (FAS)|||units on a scale||Standard Error|Mean
2670329|NCT01488019|Secondary|Rescue Medication Usage|Number of puffs of rescue medication (albuterol pMDI) used per day|0 to 52 weeks|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization.|||Mean Puffs per Day||Standard Deviation|Mean
2670330|NCT01488019|Secondary|Summary of Subjects Requiring Intubation or Non-Invasive Ventilation||0 to 52 weeks|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization.|||Participants|||Count of Participants
2670331|NCT01488019|Secondary|Health Care Utilization and Economic Impact - Number of Emergency Department Visits||0 to 52 weeks|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization.|||Participants|||Count of Participants
2670332|NCT01488019|Secondary|Transition Dyspnea Index|The Transition Dyspnea Index (TDI) measures changes in dyspnea severity from the baseline as established by the BDI. It has 3 components: change in functional impairment, change in magnitude of task, and change in magnitude of effort, and each component is rated on a scale ranging from -3 (major deterioration) to +3 (major improvement). The 3 components are summed to provide a total score ranging from -9 to +9. The lower the score, the more deterioration in severity of dyspnea.|On treatment at months 3, 6, 9 and 12|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization.|||units on a scale||Standard Error|Least Squares Mean
2670333|NCT01488019|Secondary|Saint Georges Respiratory Questionnaire Scores: Changes From Baseline at Months 3, 6, 9, 12|"Saint Georges Respiratory Questionnaire comprises 50 items in 3 sections, Symptoms, Activity, Impact, measuring health status in chronic airflow limitation. Symptoms captures level of symptomatology. Activity and Impact responses are either yes or no. Scoring is from 0 to 100; 0 = no life quality impairment. A summary score for all items is calculated and ranges from 0 to 100, where 0 indicates best possible health status, 100 represents worst possible health status. Scores are calculated using weights attached to each item in the questionnaire - 4 unit changes are clinically meaningful."|On treatment at months 3, 6, 9 and 12|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization. Only subjects with data collected were included|||units on a scale||Standard Error|Least Squares Mean
2670334|NCT01488019|Secondary|IC Changes From Baseline at Months 3, 6, 9 and 12||On treatment at months 3, 6, 9 and 12|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization. Only subjects with data collected and valid measurements included|||Litres||Standard Deviation|Mean
2670335|NCT01488019|Secondary|FVC Changes From Baseline at Months 3, 6, 9 and 12||On treatment at months 3, 6, 9 and 12|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization. Only subjects with data collected and valid measurements included|||Litres||Standard Deviation|Mean
2670336|NCT01488019|Secondary|FEV1 Changes From Baseline at Months 3, 6, 9 and 12||On treatment at months 3, 6, 9 and 12|Full Analysis Set: all subjects randomized who took at least one dose of study medication. Subjects were analyzed according to their assigned treatment at randomization. Only subjects with data collected and valid measurements included|||Litres||Standard Error|Least Squares Mean
2670337|NCT01488019|Secondary|Kaplan-Meier Probability of Protocol Defined COPD Exacerbation at 52 Weeks|COPD exacerbations were defined as events in the natural course of disease characterized by an increase from baseline in two of the following symptoms: dyspnea, cough, and sputum production that was beyond normal day-to-day variations, was acute in onset, that persisted for at least two consecutive days, and that warranted a change in their regular medication.The change could be either the initiation of additional treatment(s) or the intensification of a treatment the subject was already receiving, and the change must have been specifically to address the exacerbation event. COPD exacerbations occurring after the time of withdrawal or completion of the study were not included.|0 to 52 weeks|Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.|||percent|||Number
2670358|NCT01487525|Secondary|Isokinetic Knee Extensor Strength||0, 6 weeks||||percent change||Standard Error|Mean
2670338|NCT01488019|Secondary|Number of Subjects With Protocol-Defined COPD Exacerbation|COPD exacerbations were defined as events in the natural course of disease characterized by an increase from baseline in two of the following symptoms: dyspnea, cough, and sputum production that was beyond normal day-to-day variations, was acute in onset, that persisted for at least two consecutive days, and that warranted a change in their regular medication. The change could be either the initiation of additional treatment(s) or the intensification of a treatment the subject was already receiving, and the change must have been specifically to address the exacerbation event. COPD exacerbations occurring after the time of withdrawal or completion of the study were not included.|0 to 52 weeks|Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.|||Participants|||Count of Participants
2670339|NCT01488019|Secondary|Individual Components of the Primary Composite Endpoint - First COPD-related ER Visit and First COPD Exacerbation-Related Hospitalization||0 to 52 weeks|Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.|||Participants|||Count of Participants
2670340|NCT01488019|Secondary|Summary of All Cause Mortality, COPD Related Mortality and Respiratory Related Mortality|An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.|0 to 52 weeks|Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.|||Participants|||Number
2670341|NCT01488019|Primary|Kaplan-Meier Probability of Respiratory Death, First COPD-Related Emergency Room Visit, or First COPD Exacerbation-Related Hospitalisation at 52 Weeks|The primary endpoint was the combined incidence of respiratory death, first COPD-related ER visit or first COPD exacerbation-related hospitalization (whichever occurred first from the time of randomization to the end of the study). The time-to-first event was measured and analyzed in units of weeks and was summarized by treatment for subjects in the Safety Set. An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.|0 to 52 weeks|Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.|||percent|||Number
2670342|NCT01488019|Primary|Number of Subjects With a Primary Event of Respiratory Death, First COPD-Related Emergency Room Visit, or First COPD Exacerbation-Related Hospitalisation|The primary endpoint was the combined incidence of respiratory death, first COPD-related ER visit or first COPD exacerbation-related hospitalization (whichever occurred first from the time of randomization to the end of the study). The time-to-first event was measured and analyzed in units of weeks and was summarized by treatment for subjects in the Safety Set. An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death and COPD-relatedness.|0 to 52 weeks|Safety Set - All subjects who were randomized to treatment and took at least one dose of study medication. Subjects were analyzed according to the actual treatment they received for the majority of the study.|||Participants|||Count of Participants
2670343|NCT01487954|Secondary|Change in Urine pH|A paired sample t-test (a=0.05) assessing change in urine pH between before treatment day 0 and after radiation and alkaline water treatment day 33.|at baseline and at week 5 (day 33)|Only the first ten patients in the alkaline water group, who took part in the safety lead-in portion of the study were analyzed for urine pH|||units on pH scale||Standard Deviation|Mean
2670344|NCT01487954|Primary|Acute and Grade 2 or Higher Radiation-related Skin Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|Information will include the type, severity, time of onset and resolution of its onset, and its probable association with the study regimen. Frequency tables will be constructed to summarize observed incidents by severity and type of toxicity during weekly radiation treatment and 1 month after radiation treatment. Observed toxicity differences among the treatment arms may be reported in frequency tables.|at 1 month after treatment||||percentage of participants|||Number
2670345|NCT01487863|Primary|Cumulative CD54 Upregulation Ratio Between the Cohorts.|An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.|Over the course of sipuleucel-T therapy (approximately 1 month)|The efficacy population is defined as all randomized subjects. All the subjects in the efficacy population were analyzed according to the treatment that they were randomized to receive.|||Ratio ofCD54 molecules on BDS65:FP cells||Standard Error|Mean
2670346|NCT01487668|Secondary|Improved Mental Health-related Quality of Life|Change in SF-12 mental health scores from baseline to 12 months. The outcome is measures by changes in the Veterans short form 12-item (VR-12) survey, which includes a physical and mental health component score (PCS and MCS, respectively). Each component score (PCS and MCS) has a range of 0-100, with a higher score on the PCS and MCS indicating better outcome, or better physical or mental health-related quality of life, respectively.|12 months||||units on a scale||Standard Deviation|Mean
2670347|NCT01487668|Primary|Physical Health-related Quality of Life|The outcome is measures by changes in the Veterans short form 12-item (VR-12) survey, which includes a physical and mental health component score (PCS and MCS, respectively). Each component score (PCS and MCS) has a range of 0-100, with a higher score on the PCS and MCS indicating better outcome, or better physical or mental health-related quality of life, respectively.|12 months||||units on a scale||Standard Deviation|Mean
2670348|NCT01487577|Secondary|Pharmacokinetic Analysis of MMF Steady State Concentration to Evaluate MMF Dose Relationships to Drug Exposure.|Pharmacokinetic analysis includes, but is not limited to, steady-state concentrations.|100 days||||mcg/mL||Full Range|Median
2670349|NCT01487577|Secondary|Pharmacokinetic Analysis of MMF Clearance to Evaluate MMF Dose Relationships to Drug Exposure.|Pharmacokinetic analysis includes, but is not limited to, clearance.|100 days||||mL/min/kg||Full Range|Median
2670359|NCT01487525|Primary|Change in Isotonic Leg Press 1RM|double leg press 1 rep maximum strength|0,6 weeks||||percent change||Standard Deviation|Mean
2670362|NCT01487499|Primary|Solid Tumor Growth After Completion of Interventional Bronchoscopies|The Organization for Research and Treatment of Cancer Response Evaluation Criteria in Solid Tumors (RECIST) system will be used to grade the response to therapy.|18 months|No participants were analyzed because total enrollment numbers were too low to meet any statistical analysis.||||||
2670363|NCT01487265|Secondary|Number of Participants With Serious and Non-serious Adverse Events as a Measure of Safety.|Adverse events will be graded using CTCAE v4.3. and will be collected until 30 days after the discontinuation of study treatment for each participant. A non-serious adverse event is any untoward medical occurrence. A serious adverse event (SAE) is an event that meets one or more of the following: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; requires intervention to prevent permanent impairment or damage. Specific AE and SAE terms are provided in the Adverse event module.|Every 2 weeks for 8 weeks, then every 8 weeks thereafter, estimated 24 months|Patients that received at least one dose of study treatment|||participants|||Number
2670364|NCT01487265|Secondary|Objective Response Rate|Defined as the percentage of complete and partial responses (CR + PR) among all patients. Complete response (CR) is defined as a disappearance of all lesions; partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking the baseline sum LD as reference. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for progressive disease, taking as reference the smallest (nadir) sum LD since start of treatment.|every 8 weeks for 12 months, then every 12 weeks thereafter, estimated 18 months|patients that received at least one dose of study treatment|||percentage of participants||95% Confidence Interval|Number
2670365|NCT01487265|Secondary|Duration of Response|Defined as the time from complete or partial response (CR or PR) until objective tumor progression. Tumor measurements will be obtained using CT scans of chest, abdomen and pelvis and assessed per RECIST v 1.1. Complete response (CR) is defined as a disappearance of all lesions; partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking the baseline sum LD as reference. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for progressive disease, taking as reference the smallest (nadir) sum LD since start of treatment.|every 8 weeks for 12 months, then every 12 weeks thereafter, estimated 18 months|Of 37 participates that received study treatment, only two participants met the minimum criteria to be included (one censored, and the remaining one analyzed for duration of response)|||months|||Number
2670366|NCT01487265|Secondary|Overall Survival|Defined as the time from first treatment until death from any cause.|every 3 months after study treatment, projected 24 months|Patients that received at least one dose of study treatment|||months||95% Confidence Interval|Median
2670367|NCT01487265|Primary|Progression Free Survival at 3 Months|Percentage of patients who are alive and progression-free at 3 months (APF3) from first treatment.|3 months|Patients that were treated with at least one dose of study treatment|||percentage of participants|||Number
2670368|NCT01487200|Secondary|Change From Baseline to Each Measured Time Point Post-dose in Morning Serum Cortisol|Least square mean difference against TCA IR 40 mg|Baseline to Days 2, 3, 4, 5, 8, 14, 15, 22, 29, 36, 42 and 43|The full analysis set will include all observations from all patients who received any dose of FX006 and provide a baseline observation and at least one post baseline observation.|||nmol/L||95% Confidence Interval|Least Squares Mean
2670369|NCT01487200|Secondary|Total 24-hour Urinary Free Cortisol Excretion||Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)|FAS includes all observations from all patients who received a dose of study drug and provided a baseline observation and at least one post baseline observation.|||nmol/24h||Standard Deviation|Geometric Mean
2670370|NCT01487200|Secondary|Change From Baseline in 24-hour Urinary Free Cortisol Excretion||Baseline to Days 1-2, Baseline to Days 14-15 (Week 2) and Baseline to Days 42-43 (Week 6)|Full Analysis Set (FAS) includes all observations from all patients who received a dose of study drug and provided a baseline observation and at least one post baseline observation.|||nmol/24h||95% Confidence Interval|Least Squares Mean
2670371|NCT01487200|Primary|Characterize the Pharmacokinetic Profile of FX006 and TCA IR|Concentrations below the limit of quantification of 50 pg/mL were treated as 0.|Day 1 (1, 2, 4, 6, 8, 12 and 24 hours post dose) and Days 3, 4, 5, 8, 15, 22, 29, 36 and 43|PK population was to include all patients who received study drug and had at least one measurable concentration|||pg/mL||Standard Deviation|Geometric Mean
2670372|NCT01487200|Primary|Change From Baseline in 24-hour Weighted Mean Serum Cortisol|The primary pharmacodynamic endpoint was change from baseline (pre-dose) to Day 1-2, Day 14-15 (Week 2) and Day 42-43 (Week 6) in 24-hour weighted mean serum cortisol. This is defined as AUC over the 0-24 hour measurement period divided by 24|Days 1-2, Days 14-15 (Week 2) and Days 42-43 (Week 6)||||weighted mean serum cortisol (nmol/L)||95% Confidence Interval|Least Squares Mean
2670373|NCT01487161|Secondary|Average Weekly and Total Consumption of Rescue Medications Over 8 Weeks.||8 weeks||||tablets (1tablet= 500 mg)||Standard Error|Least Squares Mean
2670374|NCT01487161|Secondary|Clinical Global Impression of Change Scores at Week 8|The Clinical Global Impression of Change is a scale that the clinician uses to assess the participants' global function and determine if there has been an improvement or not. The clinician selects one response from the response options that gives the most accurate description of the participant's state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.|8 weeks||||units on a scale||Standard Deviation|Least Squares Mean
2670375|NCT01487161|Secondary|Patient Global Impression of Change Scores at Week 8|The Patient Global Impression of Change is a scale that aims to evaluate all aspects of participants' (patients') health and determining if there has been an improvement or not. The participant selects the one response from the response options that gives the most accurate description of his/her state of health (overall status). This is a 7-point scale, and scores range from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.|Week 8||||units on a scale||Standard Error|Least Squares Mean
2670376|NCT01487161|Secondary|Responder Status as Defined by the Proportion of Patients Achieving >20% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|8 weeks||||Participants|||Count of Participants
2670377|NCT01487161|Secondary|Responder Status as Defined by the Proportion of Patients Achieving >30% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|8 weeks||||Participants|||Count of Participants
2670378|NCT01487161|Secondary|Responder Status as Defined by the Proportion of Patients Achieving >50% Improvement From Baseline in the Mean Daily Pain Intensity Scores at Week 8|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|8 weeks||||Participants|||Count of Participants
2670379|NCT01487161|Secondary|Percent of Responders According to OMERACT-OARSI Criteria at Week 8|Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. Responders are defined as participants with high improvement in pain or function.|8 weeks||||Participants|||Count of Participants
2670380|NCT01487161|Secondary|WOMAC C (Function Subscale) Change From Baseline at Week 8|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|8 weeks||||units on a scale||Standard Error|Least Squares Mean
2670381|NCT01487161|Secondary|WOMAC B (Stiffness Subscale) Change From Baseline at Week 8|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|8 weeks||||units on a scale||Standard Error|Least Squares Mean
2670382|NCT01487161|Secondary|WOMAC A1 (Pain on Walking Question) Change From Baseline at Week 8|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|8 weeks||||units on a scale||Standard Error|Least Squares Mean
2670383|NCT01487161|Secondary|WOMAC A (Pain Subscale) Change From Baseline at Week 8|The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.|8 weeks||||units on a scale||Standard Error|Least Squares Mean
2670384|NCT01487161|Secondary|Change From Baseline to Each of Weeks 1, 2, 3, 4, 5, 6, 7, 9, and 11 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score.|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|Weeks 1-7 and Week 9 and 11|All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.|||units on a scale||Standard Error|Least Squares Mean
2670385|NCT01487161|Secondary|Change From Baseline to Each of Weeks 8, 10, and 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 10mg and 40 mg vs TCA IR 40 mg|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|Weeks 8, 10 and 12|All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.|||units on a scale||Standard Error|Least Squares Mean
2670386|NCT01487161|Primary|Change From Baseline to Week 12 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|12 weeks|All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.|||units on a scale||Standard Error|Least Squares Mean
2670387|NCT01487161|Primary|Change From Baseline to Week 10 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|10 weeks|All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.|||units on a scale||Standard Error|Least Squares Mean
2670388|NCT01487161|Primary|Change From Baseline to Week 8 in Weekly Mean of the Average Daily (24-hour) Pain Intensity Score for FX006 60 mg vs TCA IR 40 mg|"The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates no pain and 10 indicates pain as bad as you can imagine."|8 weeks|All patients who receive study treatment and have baseline and at least 1 post-dose pain evaluation.|||units on a scale||Standard Error|Least Squares Mean
2670389|NCT01486966|Secondary|Incidence of Hypoglycaemic Episodes|"All events summarized were treatment emergent hypoglycaemic events. Hypoglycaemic episodes were summarized based on the ADA classification and also according to an additional definition.~Severe hypoglycemia: ADA definition. Minor hypoglycaemic episode: an episode with symptoms with confirmation by plasma glucose (PG) < 3.1 mmol/l (56 mg/dl) and was handled by the subject himself/herself, or any asymptomatic PG value < 3.1 mmol/l (56 mg/dl).~A hypoglycaemia episode was defined as nocturnal if the time of onset was between 00:01 and 05:59 a.m. (both included), otherwise it was diurnal."|Weeks 0-2|Safety analysis set included all subjects receiving at least one dose of the trial products.|||events|||Number
2670390|NCT01486966|Secondary|Change From Baseline in Fructosamine After Two Weeks of Treatment||Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.|||Umol/L||Standard Error|Least Squares Mean
2670391|NCT01486966|Secondary|Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment|FPG target was < 6.0 mmol / L. Nocturnal hypoglycaemia was defined as a hypoglycaemic episode happened between 00:01 and 05:59 a.m. (both included).|Week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject.|||percentage (%) of subjects|||Number
2670395|NCT01486966|Secondary|Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment|The mean value of pre-lunch, pre-dinner and bedtime PG was derived from the 8-point PG profile measured before lunch, dinner and bedtime.|Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.|||mmol/L||Standard Error|Least Squares Mean
2670396|NCT01486966|Secondary|Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment|The mean 2hPPG was derived from the 8-point PG profile as the mean value of the available 120 minutes after each meal.|Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.|||mmol/L||Standard Error|Least Squares Mean
2670397|NCT01486966|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment|The FPG referred to pre-breakfast plasma glucose.|Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.|||mmol/L||Standard Error|Least Squares Mean
2670398|NCT01486966|Primary|Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment|Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile.|Week 0, week 2|Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.|||mmol/L||Standard Error|Least Squares Mean
2670399|NCT01486927|Other Pre-specified|AUC0-∞ (Part 3)|AUC0-∞ (AUC from 0 extrapolated to infinity) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion||||IU*h/dL||Standard Deviation|Mean
2670400|NCT01486927|Other Pre-specified|Cmax (Part 3)|Cmax of an initial and repeat infusion of rVIII-SingleChain with correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion||||IU/dL||Standard Deviation|Mean
2670401|NCT01486927|Other Pre-specified|Tmax (Part 3)|Tmax = time of Cmax (with correction for subject's predose plasma FVIII activity) after an initial and repeat infusion of rVIII-SingleChain.|Before infusion and at up to 12 time points within 96 hours of infusion.||||hours||Full Range|Median
2670402|NCT01486927|Other Pre-specified|Half-life (t1/2) (Part 3)|Half-life (t1/2) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion.||||hours||Standard Deviation|Mean
2670403|NCT01486927|Other Pre-specified|Mean Residence Time (MRT) (Part 3)|Mean residence time (MRT) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion.||||hours||Standard Deviation|Mean
2670404|NCT01486927|Other Pre-specified|Clearance (Cl) (Part 3)|Clearance (Cl) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion.||||mL/h/kg||Standard Deviation|Mean
2670405|NCT01486927|Other Pre-specified|Volume of Distribution at Steady-state (Vss) (Part 3)|Volume of distribution at steady-state (Vss) of an initial and repeat infusion of rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 12 time points within 96 hours of infusion.||||mL/kg||Standard Deviation|Mean
2670406|NCT01486927|Other Pre-specified|Incremental Recovery (Part 3)|Incremental recovery of an initial and repeat infusion of rVIII-SingleChain with correction for subject's predose plasma FVIII activity.|At 30 minutes after infusion||||[IU/dL]/[IU/kg]||Standard Deviation|Mean
2670407|NCT01486927|Secondary|Proportion of Bleeding Episodes Requiring 1, 2, 3 or > 3 Infusions of rVIII-SingleChain to Achieve Hemostasis|Percentage of bleeding episodes requiring 1, 2, 3 or > 3 infusions of rVIII-SingleChain to achieve hemostasis. The denominator includes all treated bleeding episodes.|During the study (up to 24 months; assessed at Months 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, 21 and 24)||||Percentage of bleeding episodes|Participants||Number
2670408|NCT01486927|Secondary|Annualized Bleeding Rate for Total Bleeds and Traumatic Bleeds|The annualized bleeding rate was derived for each subject as follows: 365.25*(number of bleeding episodes requiring treatment) / (observed treatment period of interest).|Up to 24 months||||Number of bleeds per year||Inter-Quartile Range|Median
2670409|NCT01486927|Secondary|Incremental Recovery (Part 1)|Incremental recovery of a single infusion of octocog alfa and rVIII-SingleChain with correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|At 30 minutes after infusion||||[IU/dL]/[IU/kg]||Standard Deviation|Mean
2670410|NCT01486927|Secondary|Volume of Distribution at Steady-state (Vss) (Part 1)|Volume of distribution at steady-state (Vss) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|Before infusion and at up to 10 time points within 72 hours of infusion||||mL/kg||Standard Deviation|Mean
2670411|NCT01486927|Secondary|Clearance (Cl) (Part 1)|Clearance (Cl) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|Before infusion and at up to 10 time points within 72 hours of infusion||||mL/h/kg||Standard Deviation|Mean
2670412|NCT01486927|Secondary|Mean Residence Time (MRT) (Part 1)|Mean residence time (MRT) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 10 time points within 72 hours of infusion||||hours||Standard Deviation|Mean
2670413|NCT01486927|Secondary|Half-life (t1/2) (Part 1)|Half-life (t1/2) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity.|Before infusion and at up to 10 time points within 72 hours of infusion.||||hours||Standard Deviation|Mean
2670414|NCT01486927|Secondary|Tmax (Part 1)|Tmax = time of Cmax (with correction for subject's predose plasma FVIII activity) after a single infusion of octocog alfa and rVIII-SingleChain.|Before infusion and at up to 10 time points within 72 hours of infusion||||hours||Full Range|Median
2670415|NCT01486927|Secondary|Cmax (Part 1)|Cmax of a single infusion of octocog alfa and rVIII-SingleChain with correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|Before infusion and at up to 10 time points within 72 hours of infusion||||IU/dL||Standard Deviation|Mean
2670416|NCT01486927|Secondary|AUC0-∞ (Part 1)|AUC0-∞ (AUC from 0 extrapolated to infinity) of a single infusion of octocog alfa and rVIII-SingleChain without correction for subject's predose plasma FVIII activity. FVIII activity values for octocog alfa are dose-adjusted for chromogenic potency.|Before infusion and at up to 10 time points within 72 hours of infusion||||IU*h/dL||Standard Deviation|Mean
2670417|NCT01486927|Primary|Treatment Success During the Peri-operative Surgical Sub-study|"Subjects received rVIII-SingleChain before and during surgery based on the type of surgery and the clinical status of the subject. The investigator rated the efficacy of the treatment based on a 4-point surgical treatment rating scale of excellent, good, moderate or poor/no response. Efficacy ratings of excellent or good were considered treatment success for this end point. The rate of success, defined as the percentage of surgeries with a rating of excellent or good for hemostatic efficacy on the surgical treatment scale is presented for the Surgical Population, based on the total number of surgeries (N=16) as denominator."|From the start of surgery through the post-operative recovery (generally up to 14 days after surgery)||||% of surgeries with successful treatment|||Number
2670418|NCT01486927|Primary|Annualized Spontaneous Bleeding Rate|The annualized spontaneous bleeding rate (AsBR) was derived for each subject as follows: 365.25*(number of spontaneous bleeding episodes requiring treatment) / (observed treatment period of interest).|Up to 24 months||||Number of spontaneous bleeds per year||Inter-Quartile Range|Median
2670419|NCT01486927|Primary|Inhibitor Formation to FVIII|Number of subjects who develop inhibitors to FVIII|Up to 24 months||||participants|||Number
2670420|NCT01486927|Primary|Treatment Success|"The investigator rated the efficacy of the treatment based on a 4-point rating scale excellent, good, moderate or poor/no response. Efficacy ratings of excellent or good were considered treatment success for this end point; the percentage of bleeding events with a rating of excellent or good and the 95% confidence interval are presented. The denominator includes all treated bleeding events. The 95% confidence interval is based on a model to account for within-subject correlation."|Up to 24 months||||% bleeding events successfully treated|Participants|95% Confidence Interval|Number
2670421|NCT01486810|Primary|Mean Maximum Maintained Dose of Lisdexamfetamine for at Least 1 Week of Trial.|The mean maximum daily dose of lisdexamfetamine that was maintained for at least 1 week of trial.|during 8 weeks of trial or length of participation|data available for 16 participants.|||mgs/day||Standard Deviation|Mean
2670422|NCT01486810|Primary|Number of Participants Maintained on the Maximum Lisdexamfetamine Daily Dose.|Number of participants achieving and maintained for a seven day period during the trial on the maximum daily dose of 140 mg..|during 1 week of study participation|Although 17 participants were enrolled, one participant was lost to follow-up without any post-enrollment study data, therefore 16 participants were analyzed.|||Participants|||Count of Participants
2670423|NCT01486758|Secondary|Proportion of Participants With a Physician Diagnosis of Asthma|The proportion of participants with a physician diagnosis of asthma|Week 3-52||||Percentage of participants|||Number
2670424|NCT01486758|Secondary|Number of Children Who Were Prescribed Inhaled Corticosteroids||3-52 weeks following randomization||||Number of participants|||Number
2670425|NCT01486758|Secondary|Respiratory Symptoms Following RSV Bronchiolitis|Number of days with respiratory symptoms (cough, wheeze, or shortness of breath)|3-52 weeks following randomization||||Number of days||Standard Deviation|Mean
2670426|NCT01486758|Secondary|Likelihood to Develop 3 or More Wheezing Episodes|Likelihood to develop 3 or more wheezing episodes measured by a Kaplan-Meier survival analysis|Week 3-52|A Kaplan-Meier survival analysis was conducted to compare the likelihood of developing a third episode of wheezing among participants who received azithromycin versus those who received placebo.|||percentage of participants|||Number
2670427|NCT01486758|Secondary|Rates of Drug Related GI Side Effects.||One month from randomization||||Number of participants|||Number
2670428|NCT01486758|Secondary|Concentrations of IL-8 in Nasal Lavage on Day 15||Day 15||||pg/ml||Inter-Quartile Range|Median
2670429|NCT01486758|Primary|Proportion of Participants Who Experience Subsequent Recurrent (≥2) Wheezing Episodes|Clinical outcome: The difference in the proportion of participants who experience subsequent recurrent (≥2) wheezing episodes among infants treated with azithromycin and those treated with placebo.|3-52 weeks following randomization||||Proportion of participants|||Number
2670430|NCT01486758|Primary|IL-8 Concentrations|Biological outcome: The difference in IL-8 concentrations, measured in serum on day 8 after randomization, among infants treated with azithromycin and those treated with placebo.|Day 8||||Pg/ml||Inter-Quartile Range|Median
2670431|NCT01486615|Secondary|Number of Patients With Loss of Memory for Being Transferred to Operating Room.|Patients were asked whether they recalled the event of being transferred to the operating room before anaesthesia. The lesser the number of patients with amnesia, the better the outcome.|24 hour after surgery||||Participants|||Number
2670432|NCT01486615|Primary|Change in VAS Anxiety Score Relative to Baseline at One Hour After Premedication|VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.|Changes from baseline in VAS anxiety score at one hour after premedication||||Centimeter||Standard Deviation|Mean
2670469|NCT01486199|Primary|Absorptive Clearance Rate|Absorptive clearance rate measured 80 minutes after radiopharmaceutical inhalation. Absorptive clearance is the absorptive component of the clearance of Indium 111-diethylenetriaminepentaacetic acid (In-DTPA) from the lungs.|study day 1|One pediatric subject did not deposit sufficient aerosol to be analyzed. One control subject did not perform imaging procedures after signing consent because of a low result on a screening pulmonary function testing.|||percent cleared / 80 minutes||Standard Deviation|Mean
2670433|NCT01486615|Primary|Change in VAS Anxiety Score Relative to Baseline at 30 Minutes After Premedication|VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.|Changes from baseline in VAS anxiety score at 30 minutes after premedication||||centimeter||Standard Deviation|Mean
2670434|NCT01486615|Secondary|Amount of Propofol Consumption|Dose of propofol needed for loss of response to verbal command was noted at the time of induction of general anesthesia. The lesser the propofol needed for the loss of response to verbal command, the better the outcome.|1 - 2 hour after premedication||||mg||Standard Deviation|Mean
2670435|NCT01486615|Secondary|Number of Patients With Intact Memory|Number of patients who recalled or recognized the picture number five shown one hour after premedication. The more the number of patients with intact memory, the better the outcome.|24 hour after surgery||||Participants|||Number
2670436|NCT01486615|Secondary|Orientation Score|Orientation was assessed with a 3 point scale (0=none, 1=orientation in either time or place, 2=orientation in both). Minimum score is 0 and maximum is 2. The lesser the score, the lesser the effect on patients cognition and the better the outcome.|Orientation score at one hour after premedication||||units on a scale||Inter-Quartile Range|Median
2670437|NCT01486615|Secondary|Sedation Score at One Hour After Premedication|Sedation level was assessed with a 5 point scale (0=alert, 1=arouses to voice, 2=arouses with gentle tactile stimulation, 3=arouses with vigorous tactile stimulation, 4=lack of responsiveness). Minimum score is 0 and Maximum is 4. The lesser the score, the better the outcome.|Sedation score at 1 hour after the premedication||||units on a scale||Inter-Quartile Range|Median
2670438|NCT01486615|Primary|Change in VAS Anxiety Score Relative to Baseline After Premedication|VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.|Change from baseline in VAS anxiety score at 15 minutes after premedication|sample size of 16 patients in each group was determined by a power analysis (α, 0.05; β, 0.10) assuming that there will be 50% reduction in anxiety VAS from baseline in the experimental groups and 4% in the placebo group. To compensate for dropout cases and shifting from normality in data distribution, 20 cases were studied in each group.|||Centimeter||Standard Deviation|Mean
2670439|NCT01486446|Other Pre-specified|Sleep Interference Due to Pain in Treatment Period 2, Compared to Baseline|"During Baseline and Treatment Period 2, subjects recorded sleep interference scores in their diary cards for each night (scores were recorded upon waking).~Sleep Interference due to pain is scored using an 11 point numerical rating scale where 0 = pain does not interfere with sleep and 10 = completely interferes, unable to sleep due to pain.~A lower sleep interference score compared to Baseline indicates that the subjects' pain interfered with sleep less on treatment than during Baseline."|Baseline to 14 or 21 days||||Percentage of Baseline||Inter-Quartile Range|Mean
2670440|NCT01486446|Other Pre-specified|Daily Pain (Maximum Pain Intensity) in Treatment Period 2, Compared to Baseline|"During Baseline and Treatment Period 2, subjects recorded pain scores in their diary cards 3 times each day (upon waking, lunchtime and evening).~On each recording occasion, subjects recorded the maximum pain experienced since the previous recording occasion using an 11 point numerical rating scale of pain intensity, PINRS (where 0 = no pain and 10 = worst pain imaginable).~A lower score compared to Baseline indicates that the subjects experienced less severe pain on treatment than during Baseline."|Baseline to 14 or 21 days||||Percentage of Baseline||Inter-Quartile Range|Mean
2670441|NCT01486446|Other Pre-specified|Time to Moderate Pain (Minutes) During Standard Heat Inductions in Treatment Period 2, Compared to Baseline|"A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure.~The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable.~A stopwatch was used to record the time the subject recorded a pain intensity numerical score of 5 or more (on a scale of 0-10). This time is known as Time to Moderate Pain.~A longer Time to Moderate Pain compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment."|Baseline and 14 or 21 days||||Percentage of Baseline||Inter-Quartile Range|Mean
2670442|NCT01486446|Other Pre-specified|Time to Moderate Pain (Minutes) During Standard Heat Inductions in Treatment Period 1, Compared to Baseline|"A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure.~The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable.~A stopwatch was used to record the time the subject recorded a pain intensity numerical score of 5 or more (on a scale of 0-10). This time is known as Time to Moderate Pain.~A longer Time to Moderate Pain compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment."|Baseline to Day 5||||Percentage of Baseline||Inter-Quartile Range|Mean
2670470|NCT01486043|Secondary|Hemoglobin A1c||At 1 month||||percent of hemoglobin||Full Range|Mean
2670471|NCT01486043|Secondary|Serum Fructosamine Level||At 1 month||||uM||Full Range|Mean
2670472|NCT01486043|Primary|Length of Insulin Therapy (Days)||During the 30 days of induction chemotherapy (plus or minus 2 weeks)||||days||Full Range|Mean
2670443|NCT01486446|Other Pre-specified|Time to Exit (Minutes) From Standard Heat Inductions in Treatment Period 2, Compared to Baseline|"A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure.~The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable. A stopwatch was used to record the time the heating procedure was stopped. This time is known as Time to Exit.~A longer Time to Exit compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment."|Baseline and 14 or 21 days||||Percentage of Baseline||Inter-Quartile Range|Mean
2670444|NCT01486446|Primary|Average Daily Use of Cooling for Erythromelalgia-Related Pain in Treatment Period 2|"Using diary cards, subjects recorded the use of all non-pharmacological cooling methods used to relieve their erythromelalgia (EM) pain each day during Treatment Period 2.~A smaller average number of cooling uses each day in Treatment Period 2 indicates that subjects were in less pain/required less use of cooling to relieve their EM pain and vice versa."|14-21 Days||||cooling uses/day||Inter-Quartile Range|Mean
2670445|NCT01486446|Other Pre-specified|Time to Exit (Minutes) From Standard Heat Inductions in Treatment Period 1, Compared to Baseline|"A standard heat induction was performed on multiple occasions pre-and post treatment. Subjects placed their feet in front of an electric heater for up to 75 minutes. Subjects rated their pain intensity/severity using numerical and categorical rating scales at fixed intervals before, during and after the heating procedure.~The heating procedure continued until one of the pre-defined stopping criteria were met, or when the 75 minutes were over. Subjects could stop the procedure at any time if pain was intolerable. A stopwatch was used to record the time the heating procedure was stopped. This time is known as Time to Exit.~A longer Time to Exit compared to Baseline indicates that subjects were able to tolerate the heat for a longer period when on treatment."|Baseline to Day 5||||Percentage of Baseline||Inter-Quartile Range|Mean
2670446|NCT01486446|Other Pre-specified|Average Cooling Duration (Minutes Per Day) for EM-related Pain in Treatment Period 2|"Using diary cards, subjects recorded the use and duration of all non-pharmacological cooling methods used to relieve their EM pain each day during Treatment Period 2.~A smaller average duration of cooling each day in Treatment Period 2 indicates that subjects were in less pain/required less use of cooling to relieve their EM pain and vice versa."|14-21 Days||||minutes/day||Inter-Quartile Range|Mean
2670447|NCT01486316|Other Pre-specified|Clinical Status Measures|"Characterize the difference in clinical status measures over time in each arm. Outcomes include Quality of Life (as measured by the Minnesota Living With Heart Failure Questionnaire, in which scores range from 0 (Best) to 105 (Worst), 6 Minute Hall Walk distance, and New York Heart Association (NYHA, ranging from Class I (Best) to Class IV (Worst))~Because of the small number of patients enrolled, formal statistical analyses were not performed and data were not summarized in aggregate."|0 to 18 months post-implant|Subjects randomized to the Risk Status Guided Arm|||Outcome of Patients During Guided Period|Outcome of Patients During Guided Period||Count of Units
2670448|NCT01486316|Other Pre-specified|Correlation of HFRS Status With Actions/Testing|"At scheduled visits in which the HFRS scores were available to clinicians, the scores were summarized, along with whether subjects experienced significant weight gain, high blood pressure, or reported heart failure symptoms.~Because of the small number of subjects randomized, no formal statistical analyses were performed."|6 to 18 months post-implant (HFRS Guided Arm), 13-18 months (Control Arm)|Only randomized subjects who did not exit prior to the period in which clinicians could utilized the HFRS score (6-18 months for HFRS Guided Arm, 13-18 months for Control Arm) were included in the analysis.|||Visits with high/very high score|Visits with High/Very High HFRS Score||Number
2670449|NCT01486316|Primary|Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events|"Evaluate the HFRS Algorithm prior to Heart Failure (HF) related clinical events among patients with HF and documented or suspected AF. Daily HFRS scores were calculated each day for each patient with an implanted Reveal XT device, and the scores were ordinal, with possible values of Low, Medium, High, and Very High. The objective was to assess the association between the daily scores before and after HF events (HF-related hospitalizations, clinic visits) among subjects experiencing such visits. This would only be done during follow-up periods in which physicians were blinded to the scores (see Time Frame). The score could only be generated if the subject performed a CareLink transmission of their device data during follow-up.~Because of the small number of subjects enrolled, formal statistical analyses were not performed. Subjects were partitioned by whether they (1) experienced a HF event, and (2) whether they experienced a High or Very High HFRS score."|0 to 6 months post-implant (HFRS Guided Arm), 0-12 months (Control Arm)||||participants|||Number
2670450|NCT01486264|Secondary|Time to Offset of Xeomin Effects by Injection Cycle|"The Offset Questionnaire was a single question: On most days last week, have you noticed that your CD symptoms are better, worse or the same as the week prior? Time to offset of effect was calculated from date of first onset of effect to date of offset of effects."|Week 4 up to Week 112|FAS was subset of SES participants who were randomly assigned and received at least one injection and for whom TWSTR-Severity value by a blinded rater was available at baseline injection visit and control visit 4 weeks after the 8th injection. Participants who were evaluable for this measure at a given time point were included for this assessment.|||weeks||Standard Deviation|Mean
2670451|NCT01486264|Secondary|Change From Baseline in CDIP-58 Subscales' Scores at Week 4 After the 8th Injection|The CDIP-58 assesses the health impact of CD. The CDIP-58 is composed of eight domains: head and neck (6 items; 6 to 30 points), pain and discomfort (5 items; 5 to 25 points), upper limb activities (9 items; 9 to 45 points), walking (9 items; 9 to 45 points), sleep (4 items; 4 to 20 points), annoyance (8 items; 8 to 40 points), mood (7 items; 7 to 35 points), and psychosocial functioning (10 items; 10 to 50 points). Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Negative changes from the baseline scores indicate improvement in the impact of CD on health whereas positive changes indicate worsening.|Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex)|The FAS was the subset of the SES who were randomly assigned and received at least one injection and for whom a TWSTR-Severity value by a blinded rater (primary variable) was available at the baseline injection visit and the control visit 4 weeks after the 8th injection.|||score on a scale||Standard Deviation|Mean
2670452|NCT01486264|Secondary|Change From Baseline in Cervical Dystonia Impact Profile-58 (CDIP-58) Total Score at Week 4 After the 8th Injection|The CDIP-58 assesses the health impact of CD. The CDIP-58 is composed of eight domains: head and neck (6 items; 6 to 30 points), pain and discomfort (5 items; 5 to 25 points), upper limb activities (9 items; 9 to 45 points), walking (9 items; 9 to 45 points), sleep (4 items; 4 to 20 points), annoyance (8 items; 8 to 40 points), mood (7 items; 7 to 35 points), and psychosocial functioning (10 items; 10 to 50 points). Subscale scores were transformed to a common theoretical range of 0 (no impact) to 100 (most impact). Transformation to a 0 to 100 scale for the sum scores of the sub- and total scales were done using the following formula (all single items have scores from 1 to 5): S0 to 100 =25 * ([ SO / NI] - 1), S0 to 100 = transformed sum score. SO = sum score of the original sub- / total scale. NI = number of items in the sub- / total scale. Negative changes from the baseline total score indicate improvement in the impact of CD on health whereas positive changes indicate worsening.|Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex)|The FAS was the subset of the SES participants who were randomly assigned and received at least one injection and for whom a TWSTR-Severity value by a blinded rater (primary variable) was available at the baseline injection visit and the control visit 4 weeks after the 8th injection.|||score on a scale||Standard Deviation|Mean
2670453|NCT01486264|Secondary|Change From Baseline in Clinical Global Impression-Severity|"Assessment of Clinical Global Impression Severity was scored using a 7-point scale for severity of illness, in response to the question, Considering your total clinical experience with this particular population, how ill is the participant at this time? With scores as: 0 (not assessed); 1 (normal, not ill at all); 2 (borderline ill); 3 (mildly ill); 4 (moderately ill); 5 (markedly ill); 6 (severely ill); and 7 (among the most extremely ill participants)."|Baseline and 8th injection (Week 44 for Short Flex and Week 84 for Long Flex)|FAS was subset of SES participants who were randomly assigned and received at least one injection and for whom TWSTR-Severity value by a blinded rater was available at baseline injection visit and control visit 4 weeks after the 8th injection. Participants who were evaluable for this measure at a given time point were included for this assessment.|||score on a scale||Standard Deviation|Mean
2670454|NCT01486264|Secondary|Change From Control Visit Week 4 After First Injection in Subject Satisfaction Score at Week 4 After the 8th Injection|"The Subject Satisfaction assessment for each Xeomin treatment was scored using a 10-point scale to answer the question, How satisfied are you at the moment with your current therapy? Score ranges from: 1 (completely satisfied) to 10 (completely unsatisfied)."|Week 4 and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex)|FAS was subset of SES participants who were randomly assigned and received at least one injection and for whom TWSTR-Severity value by a blinded rater was available at baseline injection visit and control visit 4 weeks after the 8th injection. Participants who were evaluable for this measure at a given time point were included for this assessment.|||score on a scale||Standard Deviation|Mean
2670455|NCT01486264|Secondary|Change From Control Visit Week 4 After First Injection in Subject-Rated Global Response at Week 4 After the 8th Injection|The Subject-Rated Global Response assessment for each Xeomin treatment was scored using a 9-point scale with a score ranging from -4 to +4 as follows: -4 (very marked worsening); -3 (marked worsening); -2 (moderately worsening); 1 (minimally worsening); 0 (no change); +1 (minimally improved); +2 (moderately improved); +3 (significantly improved); +4 (complete abolishment of signs and symptoms).|Week 4 and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex)|FAS was subset of SES participants who were randomly assigned and received at least one injection and for whom TWSTR-Severity value by a blinded rater was available at baseline injection visit and control visit 4 weeks after the 8th injection. Participants who were evaluable for this measure at a given time point were included for this assessment.|||score on a scale||Standard Error|Least Squares Mean
2670456|NCT01486264|Secondary|Change From Control Visit Week 4 After First Injection in Investigator-Rated Global Response at Week 4 After the 8th Injection|The Investigator-Rated Global Response assessment for each Xeomin treatment was scored using a 9-point scale with a score ranging from -4 to +4 as follows: -4 (very marked worsening); -3 (marked worsening); -2 (moderately worsening); 1 (minimally worsening); 0 (no change); +1 (minimally improved); +2 (moderately improved); +3 (significantly improved); +4 (complete abolishment of signs and symptoms).|Week 4 and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex)|FAS was subset of SES participants who were randomly assigned and received at least one injection and for whom TWSTR-Severity value by a blinded rater was available at baseline injection visit and control visit 4 weeks after the 8th injection. Participants who were evaluable for this measure at a given time point were included for this assessment.|||score on a scale||Standard Deviation|Mean
2670457|NCT01486264|Secondary|Change From Baseline in TWSTRS Pain Subscale Based on Unblinded Rater Assessment at Week 4 After the 8th Injection|The validated assessment scale TWSTRS was used to measure the impact of CD on participants. An unblinded rater performed all TWSTRS-Pain subscale assessments for a given participant. TWSTRS-Pain score ranges from 0 (no pain) to 20 (maximum pain).|Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex)|The FAS was the subset of the SES participants who were randomly assigned and received at least one injection and for whom a TWSTR-Severity value by a blinded rater (primary variable) was available at the baseline injection visit and the control visit 4 weeks after the 8th injection.|||score on a scale||Standard Deviation|Mean
2670458|NCT01486264|Secondary|Change From Baseline in TWSTRS Disability Subscale Based on Unblinded Rater Assessment at Week 4 After the 8th Injection|The validated assessment scale TWSTRS was used to measure the impact of CD on participant. An unblinded rater performed all TWSTRS-Disability subscale assessments for a given participant. TWSTRS-Disability score ranges from 0 (no disability) to 30 (maximum disability).|Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex)|The FAS was the subset of the SES participants who were randomly assigned and received at least one injection and for whom a TWSTR-Severity value by a blinded rater (primary variable) was available at the baseline injection visit and the control visit 4 weeks after the 8th injection.|||score on a scale||Standard Deviation|Mean
2670501|NCT01485640|Primary|Number of Subjects With Treatment Emergent AEs, SAEs or Who Discontinued Due to AEs|Primary Safety assessments included spontaneous adverse event (AE) and serious adverse events (SAEs) monitoring.|18 months|Safety Population - subjects who took at least one dose of study medication|||participants|||Number
2670459|NCT01486264|Secondary|Change From Baseline in TWSTRS Severity Subscale Based on Unblinded Rater Assessment at Week 4 After the 8th Injection|The validated assessment scale TWSTRS was used to measure the impact of cervical dystonia (CD) on participants. An unblinded rater performed all TWSTRS-Severity subscale assessments for a given participant. TWSTRS-Severity score ranges from 0 (absence of severity) to 35 (maximum severity).|Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex)|FAS was subset of SES participants who were randomly assigned and received at least one injection and for whom TWSTR-Severity value by a blinded rater was available at baseline injection visit and control visit 4 weeks after the 8th injection. Participants who were evaluable for this measure at a given time point were included for this assessment.|||score on a scale||Standard Deviation|Mean
2670460|NCT01486264|Secondary|Change From Baseline in TWSTRS Total Score Based on Unblinded Rater Assessment at Week 4 After the 8th Injection|The validated assessment scale TWSTRS was used to measure the impact of CD on participant. The scale comprised of 3 subscales: Severity, Disability, and Pain, each of which was scored independently. An unblinded rater performed all TWSTRS assessments for a given participant. TWSTRS-Severity subscale score ranges from 0 (=absence of severity) to 35 points (=maximum severity); TWSTRS-Disability subscale score ranges from 0 (no disability) to 30 (maximum disability); and TWSTRS-Pain subscale score ranges from 0 (no pain) to 20 (maximum pain). The total of these 3 comprises the TWSTRS total score which is scored from 0 (least symptoms) to 85 (worst symptoms). Higher scores indicate a greater impact of CD on participant.|Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex)|FAS was subset of SES participants who were randomly assigned and received at least one injection and for whom TWSTR-Severity value by a blinded rater was available at baseline injection visit and control visit 4 weeks after the 8th injection. Participants who were evaluable for this measure at a given time point were included for this assessment.|||score on a scale||Standard Deviation|Mean
2670461|NCT01486264|Secondary|Change From Baseline in TWSTRS Total Score Based on Blinded Rater Assessment at Week 4 After the 8th Injection|The validated assessment scale TWSTRS was used to measure the impact of CD on participants. The scale comprised of 3 subscales: Severity, Disability, and Pain, each of which was scored independently. A blinded rater performed all TWSTRS assessments for a given participant. TWSTRS-Severity subscale score ranges from 0 (=absence of severity) to 35 points (=maximum severity); TWSTRS-Disability subscale score ranges from 0 (no disability) to 30 (maximum disability); and TWSTRS-Pain subscale score ranges from 0 (no pain) to 20 (maximum pain). The total of these 3 comprises the TWSTRS total score which is scored from 0 (no symptoms) to 85 (worst symptoms). Higher scores indicate a greater impact of CD on participant.|Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex)|FAS was subset of SES participants who were randomly assigned and received at least one injection and for whom TWSTR-Severity value by a blinded rater was available at baseline injection visit and control visit 4 weeks after the 8th injection. Participants who were evaluable for this measure at a given time point were included for this assessment.|||score on a scale||Standard Deviation|Mean
2670462|NCT01486264|Primary|Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale Score Based on Blinded Rater Assessment at Week 4 After the 8th Injection|The validated assessment scale TWSTRS was used to measure the impact of cervical dystonia (CD) on participants. A blinded rater performed all TWSTRS-Severity subscale assessments for a given participant. TWSTRS-Severity subscale score ranges from 0 (=absence of severity) to 35 points (=maximum severity).|Baseline and Week 4 after the 8th injection (Week 44 to 68 for Short Flex and Week 84 to 104 for Long Flex)|The per protocol set (PPS) included all participants in the full analysis set (FAS) who was responsive to unilateral brow injection (UBI) at the 4-week control visit after initial injection or had no major protocol deviations.|||score on a scale||Standard Deviation|Mean
2670463|NCT01486238|Secondary|Proportion of Subjects Requiring Macular Laser Treatment at Week 12 and Week 24.|"There is a possibility that some subjects may not respond to the study treatment to which they have been assigned. Macular laser treatment is considered an alternative treatment for retinal edema. A lower proportion of subjects requiring macular laser treatment would indicate a superior treatment regimen.~This will be assessed at week 12, and again at week 24."|24 weeks|||||||
2670464|NCT01486238|Secondary|Mean Change From Baseline at Week 24 in Central Foveal Thickness|Optical Coherence Tomography (OCT) will be used to assess the central foveal thickness of each patient. The mean change from baseline to week 24 will be calculated for each patient.|24 Weeks|||||||
2670465|NCT01486238|Primary|Proportion of Subjects Who Gain Two or More Lines in Best Corrected Visual Acuity(BCVA) Score in the Study Eye Compared With Baseline.|The primary efficacy outcome measure is the proportion of subjects who gain two or more lines in BCVA score in the Study Eye compared with baseline at 24 weeks. The BCVA is to be measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol.|24 weeks|Proportion of subjects who gain two or more lines BCVA was calculated.|||participants|||Number
2670466|NCT01486199|Secondary|Mucociliary Clearance Rate|Mucociliary clearance rate measured 80 minutes after radiopharmaceutical inhalation. Mucociliary clearance rate is the rate of clearance of Technetium sulfur colloid (Tc-SC) from the lungs.|t=2 years, measure made 80 minutes after radiopharmaceutical inhalation|Only pediatric CF subjects performed 2 year follow-up scan. One subject did not perform the second imaging day since day one image quality was poor. Two other subjects had poor imaging data on follow up day and were therefore not included in analysis.|||percent cleared / 80 minutes||Standard Deviation|Mean
2670467|NCT01486199|Secondary|Absorptive Clearance Rate|Absorptive Clearance Rate measured 80 minutes after radiopharmaceutical inhalation. Absorptive clearance is the absorptive component of the clearance of In-DTPA from the lungs.|t=2 years|Only pediatric CF subjects performed 2 year follow-up scan. One subject did not perform the second imaging day since day one image quality was poor. Two other subjects had poor imaging data on follow up day and were therefore not included in analysis.|||percent cleared / 80 min||Standard Deviation|Mean
2670468|NCT01486199|Primary|Mucociliary Clearance Rate|Mucociliary clearance rate measured 80 minutes after radiopharmaceutical inhalation. Mucociliary clearance rate is the rate of clearance of Technetium sulfur colloid (Tc-SC) from the lungs.|study day 1|One pediatric subject did not deposit sufficient aerosol to be analyzed. One control subject did not perform imaging procedures after signing consent because of a low result on a screening pulmonary function testing.|||percent cleared / 80 minutes||Standard Deviation|Mean
2670473|NCT01485991|Secondary|Percentage of Participants With Viral Relapse|Participants are considered to have a viral relapse if both conditions as specified are met: 1) <25 IU/mL undetectable HCV RNA at the actual end of study drug treatment; 2) confirmed HCV RNA greater than or equal to (>=) 25 IU/mL during follow-up.|End of Treatment (Week 48) up to Follow-up Period (until Week 72)|ITT population included all randomized participants who took at least 1 dose of study drug. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||percentage of participants|||Number
2670474|NCT01485991|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)|Participants are considered to have reached SVR24 if both conditions below are met: 1) HCV RNA levels less than <25 International unit per milliliter (IU/mL) undetectable (at the actual end of treatment);2) HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable (24 weeks after the planned EOT).|24 Weeks After the Planned EOT (Week 48)|ITT population included all randomized participants who took at least 1 dose of study medication.|||percentage of participants|||Number
2670475|NCT01485991|Primary|Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)|Participants are considered to have reached SVR12 if both conditions below are met: 1) HCV RNA levels less than (<) 25 International unit per milliliter (IU/mL) undetectable; 2) HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable.|12 Weeks After the Planned End of Treatment (EOT: Week 48)|Intent-to-treat (ITT) population included all randomized participants who took at least 1 dose of study medication.|||percentage of participants|||Number
2670476|NCT01485887|Secondary|Change From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) at Each Post Baseline Time Point|QIDS16-SR-J is a self-rated scale used in patients with major depressive disorder to measure the overall severity of depressive symptoms: 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease/increase in appetite/weight; and 9) psychomotor agitation/retardation. QIDS16-SR-J items are rated on a scale of 0 to 3, and the total score ranges from 0 to 27. Higher scores indicate more severe symptoms. Change from baseline: mean score at observation minus mean score at baseline.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 12, 24, 44|Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score and QIDS16-SR-J score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.|||Units on a scale||Standard Deviation|Mean
2670477|NCT01485887|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) Score at Each Post Baseline Time Point|CGI-I is a 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44|Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.|||Units on a scale||Standard Deviation|Mean
2670478|NCT01485887|Secondary|Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Each Post Baseline Time Point|CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. Change from baseline: mean score at observation minus mean score at baseline.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44|Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.|||Units on a scale||Standard Deviation|Mean
2670479|NCT01485887|Secondary|Change From Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D17) at Each Post Baseline Time Point|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 (8 items) or 0 to 4 (9 items), and the total score ranges from 0 to 52. Higher scores indicate more severe symptoms. Change from baseline: mean score at observation minus mean score at baseline.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44|Participants who recieved at least one dose of study drug in this study , and had at least one evaluable HAM-D17 score after Week 8 of the preceding study B2411263 (NCT01441440). 'n' is signifying those participants who were evaluated for this measure at each time point.|||Units on a scale||Standard Deviation|Mean
2670480|NCT01485887|Primary|Number of Participants With no at Baseline and Yes at Any Post Baseline for Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories|C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants who received at least one dose of the study drug.|||Participants|||Number
2670481|NCT01485887|Primary|Number of Participants With Clinical Significant Electrocardiogram (ECG) Changes|Clinically significant ECG findings included: corrected QT (QTc), QT interval corrected using the Bazett's formula (QTcB), and QT interval corrected using the Fridericia formula (QTcF)> 450 millisecond (ms), >480 ms, and >500 ms respsctively, change from baseline in QTc, QTcB, and QTcF >= 30 ms, and >= 60 ms, respectively.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants with at least one observation of the electrocardiogram while on study treatment.|||Participants|||Number
2670482|NCT01485887|Primary|Number of Participants With Clinical Significant Laboratory Tests Changes|Clinical significant changes were pre-defined for each laboratory test based on the criteria: Red Blood Cell Count <0.8 x lower limit normal (LLN); Lymphocytes (%) <0.8 x LLN; Eosinophils (%) >1.2 x upper limit normal (ULN); Total Bilirubin >1.5 x ULN; Alanine Aminotransferase (ALT) >3.0 x ULN; Gamma glutamyl transferase (GGT) >3.0 x ULN; Uric Acid >1.2 x ULN; Cholesterol >1.3 x ULN; Low density lipoprotein (LDL) cholesterol >1.2 x ULN; Triglycerides >1.3 x ULN; Glucose >1.5 x ULN; Urine Glucose [qualitative (Qual)] >=1; Urine Protein (Qual) >=1; Urine Blood/Hemoglobin (Hgb) (Qual) >=1.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants with at least one observation of the given laboratory test while on study treatment or during lag time.|||Participants|||Number
2670483|NCT01485887|Primary|Number of Participants With Clinical Significant Vital Changes|Clinical significant changes were pre-defined for systolic blood pressure (SBP), diastolic blood pressure (DBP) , and pulse rate (PR). An average value of 3 measurements in each visit meeting the following criteria for 3 consecutive visits was determined as clinical siginificant changes: DBP >= 90 mmHg with change from the baseline >= 10 mmHg; SBP >= 140 mmHg with change from the baseline >= 20 mmHg; PR >= 100 bpm with change from the baseline >= 15 bpm.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants who received at least one dose of the study drug.|||Participants|||Number
2670484|NCT01485887|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect.|Baseline (Week 8 of the preceding double-blind study B2411263 [NCT01441440]) up to 10 months|Participants who recieved at least one dose of the study drug.|||Participants|||Number
2670485|NCT01485796|Secondary|Number of Weeks to Reach Final 3 or 4-week Dose Interval|Non-parametric descriptive statistics (median, range) are provided.|7 months (per subject)|Of 36 participants treated with study drug in Epoch 2, 6 reached a final dose interval of 3 weeks and 30 reached a final dose interval of 4 weeks.|||weeks||Full Range|Median
2670486|NCT01485796|Secondary|Maximum Infusion Rate in Epoch 1 and Epoch 2|Non-parametric descriptive statistics (median, range) are provided.|7 months (per subject)|The number of participants analyzed for Epoch 1 is 37, as 37 participants were treated with study drug in Epoch 1. The number of participants analyzed for Epoch 2 is 36, as 36 participants were treated with study drug in Epoch 2.|||mL/h||Full Range|Median
2670487|NCT01485796|Secondary|Duration of Infusion in Epoch 1 and Epoch 2|Non-parametric descriptive statistics (median, range) are provided.|7 months (per subject)|The number of participants analyzed for Epoch 1 is 37, as 37 participants were treated with study drug in Epoch 1. The number of participants analyzed for Epoch 2 is 36, as 36 participants were treated with study drug in Epoch 2.|||hours||Full Range|Median
2670488|NCT01485796|Secondary|Number of Infusion Sites (Needle Sticks) Per Month in Epoch 1 and Epoch 2|Non-parametric descriptive statistics (median, range) are provided.|7 months (per subject)|The number of participants analyzed for Epoch 1 is 37, as 37 participants were treated with study drug in Epoch 1. The number of participants analyzed for Epoch 2 is 36, as 36 participants were treated with study drug in Epoch 2.|||infusion sites (needle sticks)||Full Range|Median
2670489|NCT01485796|Secondary|Number of Infusions Per Month in Epoch 1 and Epoch 2|Non-parametric descriptive statistics (median, range) are provided.|7 months (per subject)|The number of participants analyzed for Epoch 1 is 37, as 37 participants were treated with study drug in Epoch 1. The number of participants analyzed for Epoch 2 is 36, as 36 participants were treated with study drug in Epoch 2.|||infusions||Full Range|Median
2670490|NCT01485796|Secondary|Trough Levels of Immunoglobulin G (IgG)|IgG trough levels at the beginning of Study Epoch 1 (previous immunoglobulin treatment) and at the end of Study Epoch 2 were analyzed.|7 months (per subject)|At screening, data (ie, IgG trough levels) were available for analysis from 36 participants. At the end of Epoch 2, data were available for analysis from only 33 participants.|||g/L||95% Confidence Interval|Geometric Mean
2670491|NCT01485796|Secondary|Number of Subjects Who Develop Neutralizing Antibodies to rHuPH20||7 months (per subject)||||subjects|||Number
2670492|NCT01485796|Secondary|Rate of All Adverse Events (Excluding Infections) Per Infusion|A point estimate and 95% confidence interval for the rate of adverse events per infusion was derived using a Poisson model.|7 months (per subject)||||adverse events||95% Confidence Interval|Number
2670493|NCT01485796|Secondary|Number of All Related Adverse Events (Excluding Infections)||7 months (per subject)||||adverse events|||Number
2670494|NCT01485796|Secondary|Rate of Related Local Adverse Events (Excluding Infections) Per Infusion|A point estimate and 95% confidence interval for the rate of related local adverse events per infusion was derived using a Poisson model.|7 months (per subject)||||adverse events||95% Confidence Interval|Number
2670495|NCT01485796|Secondary|Number of Related Local Adverse Events (Excluding Infections)||7 months (per subject)||||adverse events|||Number
2670496|NCT01485796|Secondary|Proportion of Subjects Who Maintain a Treatment Interval of 3 or 4 Weeks in Epoch 2 for 24 Weeks||6 months (per subject)||||subjects|||Number
2670497|NCT01485796|Secondary|Proportion of Subjects Who Achieve a Treatment Interval of 3 or 4 Weeks in Epoch 2||6 months (per subject)||||subjects|||Number
2670498|NCT01485796|Primary|Rate of Related Systemic Adverse Events (Excluding Infections) Per Infusion|A point estimate and 95% confidence interval for the rate of related systemic adverse events per infusion was derived using a Poisson model.|7 months (per subject)||||adverse events||95% Confidence Interval|Number
2670499|NCT01485796|Primary|Number of Related Systemic Adverse Events (Excluding Infections)||7 months (per subject)||||adverse events|||Number
2670500|NCT01485640|Secondary|Change From Baseline to Month 18 (LOCF) in the Clinical Global Impression Severity Score (CGI-S|The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.|18 months|Only 153 subjects who had baseline and at least one post-baseline assessments.|||units on a scale||Standard Deviation|Mean
2670502|NCT01485627|Secondary|Health Care Utilization- Mean Index Score of Aggressive Care at the End of Life|Patient charts were audited for 3 outcomes : 1) chemotherapy use, 2) aggressive treatments and 3) emergency department or hospital utilization. The total scores ranged from 0-6 with higher scores indicated worse outcomes. The sums of the means for the 3 outcomes were added to provide the total score.|3 years|Health care utilization was assessed in patients only.|||units on a scale||Standard Deviation|Mean
2670503|NCT01485627|Secondary|Caregiver Mean Overall Mental Health as Measured by the SF-12 Assessment|SF-12 scores are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|7 months|Sf-12 was given to the caregivers only.|||units on a scale||Standard Deviation|Mean
2670504|NCT01485627|Secondary|Aim 2 Patient Well-being|Original McGill quality of life and the FACT-G assessment tools were used. For the McGill tool scores range from 1 to 10 with higher scores indicating better outcome. For FACT-G scores range from 0 to 4. Higher score means a better outcome. Different parts of the McGill and FACT-G tools were used to create 5 standardized z scores: McGill QOL Scale single item, McGill Psychological Well-Being sub-scale, McGill Existential Well-Being sub-scale, FACT-G Physical Functioning sub-scale and FACT-G Social Functioning sub-scale. Sum of the five standardized z-scores is the Aggregate QOL score. A higher Z score indicates better outcomes. The maximum possible Z-score ranged from -3.54 to 1.24.|3 years|This outcome measure was assessed in patients only.|||standardized score on a scale||Standard Deviation|Mean
2670505|NCT01485627|Secondary|Aim 1b&c Mean Difference in Reported Expectation of Survival in 2 Years Between Patients and Physicians|Patients and physicians were asked what the likelihood of survival in 2 years would be for the patient. They chose from 0, 10, 25, 50, 75, 90, 100% chance of survival in two years. A value of 0-6 was assigned to each pair of data. 0 indicating no difference in the reported value between patient and physician and 6 indicating the largest difference. For example if the physician said 100% and the patient said 0% the score was 6. The mean scores were reported by arm.|3 years|This outcome measure was assessed in patients only.|||units on a scale||Standard Deviation|Mean
2670506|NCT01485627|Secondary|Caregiver Mean Prolonged Grief Symptoms as Measured by PG-13|The prolonged grief (PG-13) instrument was used to measure prolonged grief. The tool is a sum of ten items that measure separation distress, duration of grief, cognitive, emotional, and behavioral symptoms and impairment criterion. The range of the score is 10-50 with higher scores indicating more severe symptoms.|7 months|This instrument was used with caregivers only.|||units on a scale||Standard Deviation|Mean
2670507|NCT01485627|Primary|Mean Patient-centered Communication in Advanced Cancer Score|We audio recorded the first physician visit after the coaching session (for intervention) or after study entry (control).The primary outcome was a composite of 4 pre-specified communication measures: 1. engaging patients in consultations, responding to patients' emotions, informing patients about prognosis and treatment choices and balanced framing of decisions. Coding of the 4 measures was performed by teams of trained university students who were audited continuously and blinded to study hypotheses and group assignment. We transformed each of the 4 component scores to z scores based on the pre-randomization phase sample means (SDs): z = (Raw Score - Pre-randomization Phase Mean)/Pre-randomization Phase SD. The 4-component z-scores were averaged to form the primary outcome. A higher Z score indicates better communication. The maximum possible Z-score ranged from -0.69 to 20.08.|3 years|This outcome measure was assessed in patients only.|||standardized score on a scale||Standard Deviation|Mean
2670508|NCT01485536|Primary|Overall Response Rate (ORR)|Percentage of participants with objective response defined as Complete (CR) and Partial (PR) Response. Computed tomography (CT) and Positron emission tomography (PET) scans done after every 2 cycles to assess efficacy using Cheson Criteria (2007) which lists CR as disappearance of all evidence of disease, and PR as regression of measurable disease and no new sites.|Up to 12 cycles or 48 weeks|One participant withdrew therefore was not evaluable for the outcome and is excluded from analysis|||percentage of participants|||Number
2670509|NCT01485536|Primary|Objective Response in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) and Peripheral T-cell Lymphoma (PTCL)|Objective Response defined as Complete (CR) and Partial (PR) Response. Computed tomography (CT) and Positron emission tomography (PET) scans done after every 2 cycles to assess efficacy using Cheson Criteria (2007) which lists CR as disappearance of all evidence of disease, and PR as regression of measurable disease and no new sites.|56 days|One participant withdrew therefore was not evaluable for the outcome and is excluded from analysis|||Participants|||Count of Participants
2670510|NCT01485393|Secondary|Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep|The PVT is a measure of reaction time. It is measured as Lapse 400, which is the number of responses on the PVT greater than 400 milliseconds.|Approximately 30 minutes after waking up|All patients undergo both zolpidem- and dexmedetomidine-induced sleep. Data analysis for this cohort was performed irrespective of randomization order.|||responses|||Number
2670511|NCT01485393|Primary|Change in Sleep Quality|Sleep quality will be assessed objectively through EEG measures (changes from baseline in length of non-REM sleep, length of REM sleep, and length of N3 sleep--all assessed in minutes) and subjectively, utilizing a post sleep questionnaire to assess the difference in quantity of sleep (minutes) from baseline. Sleep quality is directly related to these measures of sleep quantity.|Approximately 8 hours|All patients undergo both zolpidem- and dexmedetomidine-induced sleep. Data analysis for this cohort was performed irrespective of randomization order.|||minutes||Inter-Quartile Range|Median
2670512|NCT01485380|Primary|Number of Participants With Changes in the Brains Default Mode Network.|Number of participants with changes in the Default Mode network during loss and recovery of consciousness under dexmedetomidine induced sedation versus baseline as assessed by changes in blood oxygen level depended (BOLD) signals during the awake, unconscious, and recovery states.|1.5hrs|All 17 participants were analyzed. Blood oxygen level depended (BOLD) signals during the awake (n = 16), unconscious (n = 16), and recovery (n = 15) states were included in the final data set.|||participants|||Number
2670536|NCT01485094|Secondary|Difference in Patient's Global Impression of Change|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the 7 day treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.|Day 7 (end of double blind treatment)|Intention-to-treat|||participants|||Number
2670513|NCT01485354|Secondary|Change in Grip Strength (Strength Test) (i.e. Difference Between Grip Strength at Baseline and at Completion of the 3-week Intervention)|This test is carried out by using a hand dynamometer that measures the grip strength of the individual in kilograms (used as a measure of force). Subjects are instructed to position the thumb on one handle of the dynamometer and the other fingers on the other handle of the dynamometer. The device measures the force generated by the subject using a power grip. The investigators computed the difference between the Grip Strength value at completion of the 3-week intervention and the Grip Strength value at baseline.|Data collected at baseline and at completion of the 3-week intervention|Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.|||kg||Standard Deviation|Mean
2670514|NCT01485354|Secondary|Change in Box and Block Test Score (Manual Dexterity Test) (i.e. Difference Between Box and Block Test Score at Baseline and at Completion of the 3-week Intervention)|The Box and Block test is designed to assess manual dexterity in subjects with motor impairments. Subjects are asked to move small wooden blocks from one box to another, moving their stroke-affected arm over a divider between the two boxes. The output of the test is the number of blocks that the subject moves from one box to the other within a set amount of time (i.e. 1 min). Older adults who are otherwise healthy would typically move 60 to 70 blocks in 1 min. Hence, the range of the scale for older adults is 0 to 70. The investigators computed the difference between the Box and Block Test score at completion of the 3-week intervention and the Box and Block Test score at baseline.|Data collected at baseline and at completion of the 3-week intervention|Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.|||number of blocks||Standard Deviation|Mean
2670515|NCT01485354|Secondary|Change in Functional Ability Scale Score (Scale to Rate Quality of Movement) (i.e. Difference Between Functional Ability Scale Score at Baseline and at Completion of the 3-week Intervention)|The Functional Ability Scale is designed to assess the quality of movement during the performance of a battery of functional tasks. Therapists observe the subject while performing the motor tasks and use an ordinal scale to rate the quality of movement. The scale used to rate each motor task ranges from 0 to 5. The Functional Ability Scale is derived by adding up the scores for each motor task performed by the subject. Subjects perform 15 motor tasks. Hence the Functional Ability Scale score varies from 0 (very poor quality of movement) to 75 (physiological movement). The investigators computed the difference between the Functional Ability Scale score at completion of the 3-week intervention and the Functional Ability Scale score at baseline.|Data collected at baseline and at completion of the 3-week intervention|Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.|||units on a scale||Standard Deviation|Mean
2670516|NCT01485354|Secondary|Change in Wolf Motor Function Test Score (a Functional Test) (i.e. Difference Between Wolf Motor Function Test Score at Baseline and at Completion of the 3-week Intervention)|The Wolf Motor Function test is designed to assess the severity of functional limitations in stroke survivors. The scale is administered by asking subjects to perform a series of functional movements (e.g. reach for and pick up a paperclip). The outcome of the assessment is the average time needed to perform the motor tasks that are part of the assessment. The score ranges from 0 to 120 s (i.e. if the subject is unable to perform the task, the score for that task is set to 120 s). The investigators computed the difference between the Wolf Motor Function Test score at completion of the 3-week intervention and the Wolf Motor Function Test score at baseline.|Data collected at baseline and at completion of the 3-week intervention|Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.|||sec||Standard Deviation|Mean
2670517|NCT01485354|Primary|Change in Upper-extremity Fugl-Meyer Score (Measure of Motor Impairment) (i.e. Difference Between Fugl-Meyer Score at Baseline and at Completion of the 3-week Intervention)|The upper-extremity Fugl-Meyer scale allow one to assess the severity of motor impairments in stroke survivors using a scale from 0 (severe impairment) to 66 (no impairment). It is based on visual observations gathered by asking subjects to perform upper-limb movements using the stroke-affected limb. Therapists rate the performance of the motor tasks using an ordinal scale ranging from 0 (cannot perform) to 2 (can perform fully) that captures the motor ability of the individual. The investigators computed the difference between the Fugl-Meyer score at completion of the 3-week intervention and the Fugl-Meyer score at baseline.|Data collected at baseline and at completion of the 3-week intervention|Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.|||units on a scale||Standard Deviation|Mean
2670518|NCT01485172|Secondary|Percentage of Participants Withdrawn From the Study Due to Lack of Efficacy|The percentage of participants who withdrew from the study due to lack of efficacy as defined by either the participant or the investigator is presented here.|Up to Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Percentage of participants|||Number
2670519|NCT01485172|Secondary|Responder Rate According to the Clinical Global Impression - Global Improvement (CGI-I) Scale|"The CGI-I scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The scale is rated from 1-7 where 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The responder rate is defined as the percentage of participants with a score of 1 or 2."|Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Percentage of participants|||Number
2670547|NCT01484938|Primary|Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30|Corneal staining type was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0=none; 1=micropunctate; 2=macropunctate; 3=coalesced macropunctate; 4=patch (>/= 1 mm). The five regions were summed, for a summed total range of 0-20.|Baseline (Day 0), Day 30|Intent to treat. All subjects who were enrolled in the study and completed at least one on-regimen study visit were evaluable for intent-to-treat analyses.|||Units on a scale||Standard Deviation|Mean
2670520|NCT01485172|Secondary|Change From Baseline in the UPDRS Part I (Mentation)|"The UPDRS Part I scores mentation, behavior and mood as determined by a physician and participants were tested during the on phase of Parkinson's. This component of the UPDRS is the total score for 4 items (the items 1- 4 include intellectual impairment, thought disorder, motivation/initiative, and depression) and may have a value ranging from 0 to 16 as determined by a physician where 16 indicates the maximum score and the worse condition. All 4 items have to be present for a total score to be calculated. If one or more items are missing, the total score for the component will also be missing. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Score on a scale||95% Confidence Interval|Least Squares Mean
2670521|NCT01485172|Secondary|Change From Baseline in the Total UPDRS Score (Parts I-III)|"The total UPDRS score was calculated by the sum of the values for each component (Part I + Part II + Part III) as determined by the physician. The UPDRS Part I scores mentation, behavior and mood and scores can range from 0-16. The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and scores range from 0-108. The total UPDRS (Part I + II + III) scores can range from 0-176 with the higher score indicating the worse condition. Tests were performed when the participant is in the on state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Score on a scale||95% Confidence Interval|Least Squares Mean
2670522|NCT01485172|Secondary|Change From Baseline in UPDRS Activities of Daily Living|"The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The higher score indicates the worse condition. Tests were performed when the participant is in the on state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Score on a scale||95% Confidence Interval|Least Squares Mean
2670523|NCT01485172|Secondary|Change From Baseline in UPDRS Parts II and III Combined|"The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts II and III can range from 0-160 with the higher score indicating the worse condition. Tests were performed when the participant is in the on state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2670524|NCT01485172|Secondary|Responder Rate Defined as Participants With a >=30% Reduction in Baseline UPDRS Motor Score|The responder rate is defined as the percentage of participants with a greater than or equal to (>=)30% reduction in their individual Baseline UPDRS motor score at Week 4 of the Maintenance Period (Study Week 17). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Percentage of Participants|||Number
2670525|NCT01485172|Secondary|Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Parts II and III Combined|"The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part III is the Motor Examination (Total Motor Score [TMS]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts II and III can range from 0-160 with the higher score indicating the worse condition. Tests were performed when the participant is in the on state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date."|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Participants|||Number
2670526|NCT01485172|Secondary|Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Motor Score|The UPDRS motor scores can range from 0-108 where the maximum score indicates the worse condition. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Participants|||Number
2670527|NCT01485172|Secondary|Number of Participants With a >=5 Points Reduction From Baseline in UPDRS Motor Score|The UPDRS motor scores can range from 0-108 where the maximum score indicates the worse condition. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values.|Baseline and Week 4 of the Maintenance Period (Study Week 17)|ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed|||Participants|||Number
2670579|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in CRP||Day 43 of Period 1, Day 29 of Period 2|FAS|||mg/L||Standard Error|Least Squares Mean
2670580|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in CRP||Day 1 of Period 1, Day 29 of Period 2|FAS|||mg/L||Standard Error|Least Squares Mean
2670528|NCT01485172|Primary|Change From Baseline (BL) in Unified Parkinson Disease (PD) Rating Scale (UPDRS) Motor Score|The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. One of the six features include the Part III - Motor Examination where scores can range 0-108 where the maximum score indicates the worse condition. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the individual post-randomization values. The least squares(LS) means were estimated using the mixed model repeated measures(MMRM) adjusting for BL UPDRS motor score and race(white versus other) or by using the non-parametric rank analysis of covariance(ANCOVA).|Baseline and Week 4 of the Maintenance Period (Study Week 17)|Intent to Treat (ITT) Population: all randomized subjects who received at least one dose of study medication, had a Baseline efficacy assessment for the specific outcome, and had at least one respective efficacy outcome assessment collected after randomization (Baseline) visit, i.e. had at least one respective Post-Baseline efficacy assessment.|||Score on a scale||95% Confidence Interval|Least Squares Mean
2670529|NCT01485120|Primary|Performance Comparison: NIBP Forearm Cuff Using Classic Algorithm vs. Invasive Radial Blood Pressure Reading|NIBP Forearm cuff systolic and diastolic values using Classic algorithm difference compared to invasive radial blood pressure readings (both readings obtained simultaneously).|Approximately 2 hours|Blood Pressure (BP) monitoring using invasive arterial insertion as a standard reference, and an investigational, non-invasive blood pressure (NIBP) monitoring cuff. Data obtained from the cuff used the Classic NIBP algorithm for output.|||mmHg||Standard Deviation|Mean
2670530|NCT01485120|Primary|Performance Comparison: NIBP Forearm Cuff Using SuperStat Algorithm vs. Invasive Radial Blood Pressure Reading|NIBP Forearm cuff systolic and diastolic values using SuperStat algorithm compared to invasive radial blood pressure systolic and diastolic values (both obtained simultaneously).|Approximately 2 hours|Blood Pressure (BP) monitoring using invasive arterial insertion as a standard reference, and an investigational, non-invasive blood pressure (NIBP) monitoring cuff. Data obtained from the cuff used the SuperStat algorithm for output.|||mmHg||Standard Deviation|Mean
2670531|NCT01485094|Secondary|Daily Current Pain Intensity|"Participants recorded their current pain intensity score 3 times a day, using a 0 -10 (11 point) Numeric Rating Scale where a rating of 0 corresponded to No Pain and a rating of 10 to Pain as bad as you can imagine.~The daily current pain intensity reported was derived as the mean of the 3 current pain intensity assessments taken on the day from all participants in the treatment group.~The lower the value on the 11 point scale the less pain was reported on a treatment."|Baseline; Day 10|Intent-to-Treat.|||units on a scale||Standard Deviation|Mean
2670532|NCT01485094|Secondary|Change in painDETECT Grading From Baseline (Day -1) to End of Double-blind Treatment (Day 7)|"The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated between 0 and 38 for each participant. Participants with a score between 0 and 12 are graded as negative and having no neuropathic pain component. Scores between 19 and 38 result in a positive grading, in other words having presence of neuropathic component. Values from 13 to 18 result in participants being graded as having an unclear neuropathic component to their pain. The painDETECT questionnaire was first administered on Day-1 (baseline). The data reported is for before treatment start (Day -1) and the change from baseline on Day 7 (end of the double-blind period)."|Day 7 (end of double blind treatment)|Intent-to-treat. 5 participants did not complete the painDETECT questionnaire on Day 7. Two participants in both the placebo and pregabalin treatment arm and 1 in the GRT6010 treatment arm.|||participants|||Number
2670533|NCT01485094|Secondary|Difference in Leeds Sleep Evaluation Questionnaire After 7 Days of Treatment|"On the last day of the double-blind treatment period sleep was evaluated using the Leeds sleep evaluation questionnaire. This questionnaire has 10 self-rating 100 mm line analogue questions concerning sleep and early morning behavior. The higher the score, i.e. the closer the value is to 100 the worse the rating by the participant.~The 10 responses are grouped into 4 subscores:~The ease of getting to sleep.~The perceived quality of sleep.~The ease of awakening from sleep.~The integrity of behavior following wakefulness."|Day 7|Intention-to-treat. No responses were obtained from 2 participants, one in the placebo and one in the pregabalin treatment arm.|||units on a scale||Standard Deviation|Mean
2670534|NCT01485094|Secondary|Change in Area of Static Allodynia and Dynamic Allodynia From Baseline|"Allodynia is pain due to a stimulus that does not normally provoke pain. To measure the areas of dynamic and static allodynia, a point lying in the center of the area of maximum pain was marked at baseline (Day -2 and -1). From the baseline point, 8 radii were drawn.~The area of dynamic allodynia was determined by gently stroking the skin with a standardized brush along the lines. The participant was asked to report when the sensation became unpleasant.~The area of static allodynia was determined by a 128 mN (millinewton) pinprick stimulus along the lines of the 8 radii while asking the subject to report when the sensation became unpleasant.~The area was calculated from the summing of the 8 triangles that are generated from the points along each of the 8 radii at which unpleasantness was reported. The larger the area in square centimeters the more allodynia. A reduction in the area of allodynia indicates improvement."|Baseline; Day 7 (end of double blind treatment)|Intent-to-treat|||square centimeters||Standard Deviation|Mean
2670535|NCT01485094|Secondary|The Difference Between Baseline and End-of-double-blind Treatment Scores for Dynamic Mechanical Allodynia and Mechanical Pain Sensitivity Compared to Placebo|"Allodynia is pain due to a stimulus that does not normally provoke pain. Dynamic mechanical allodynia was assessed using a set of 3 light tactile stimulators as moving innocuous stimuli.~Each participant gave numerical pain ratings for each of 15 stimuli at the affected side.~Mechanical pain sensitivity was assessed using a set of 7 weighted pinprick stimuli to obtain the stimulus-response function for pinprick-evoked pain.~The participant gave a numerical pain ratings for each of 35 pinprick stimuli at the affected site.~Dynamic mechanical allodynia and mechanical pain sensitivity was calculated as the geometric mean of all numerical ratings. The values obtained on Day -2 and -1 were taken as the baseline and values on Day 6 and 7 were taken as the end of treatment. A negative change indicates an improvement on the 0 (no pain) to 100 point scale, where 100 indicates the worst imaginable pain."|Day 7 (end of double blind treatment)|Intention-to-treat|||units on a scale||Standard Deviation|Mean
2670581|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in CRP||Day 1 of Period 1, Day 43 of Period 1|FAS|||mg/L||Standard Error|Least Squares Mean
2670537|NCT01485094|Secondary|Change in Neuropathic Pain Symptom Inventory Scores on Day 7 From Baseline (Day -1)|"The Neuropathic Pain Symptom Inventory (NPSI) Score is an assessment of neuropathic pain symptoms.~A participant answered 10 questions on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable).~The total NPSI score is the sum of all ten responses and ranges between 0 and 100.~The baseline score and the mean NPSI change is reported over the double-blind treatment period. A negative mean change in score on Day 7 indicates an improvement on this 0 to 100 point scale from baseline for the total score.~For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) subscores a negative mean change indicate an improvement on the 11 point scale. A participant will score 10 to indicates the worst imaginable symptom, e.g. worst burning imaginable. A participant will score 0 if there is no burning, i.e. the symptom is absent."|Day -1; Day 7 (end of double blind treatment)|intent-to-treat|||units on a scale||Standard Deviation|Mean
2670538|NCT01485094|Secondary|Onset of Ongoing Pain Relief|"Onset of ongoing pain relief defined as the first time-point at which the participant reports a decrease of more than 1-point reduction in ongoing pain relative to baseline (day -3 to day -1), after start of treatment with study drug on Day 1. Study drug intake started on Day 1.~Due to the early termination of the trial this analysis was not performed."|Day 1 to Day 7 (end of double blind treatment)|Due to the early termination of the trial this analysis was not performed.||||||
2670539|NCT01485094|Secondary|Onset of Current Pain Relief|"Onset of current pain relief defined as the first time-point at which the participant reports a decrease of a 1-point reduction in current pain relative to baseline (day -3 to day -1), after start of treatment with study drug on Day 1.~Due to the early termination of the trial this analysis was not performed."|Day 1 to Day 7 (end of double blind treatment)|Due to the early termination of the trial this analysis was not performed.||||||
2670540|NCT01485094|Secondary|Assessment of Responder Rates|"The assessment was performed on Day 7.~The percentage of change from baseline (Day -3 to Day -1, i.e. the 3 days in the days prior to first dose) in the daily ongoing pain intensity was calculated at Day 7.~The percentage of change from baseline in the daily ongoing pain intensity was calculated at Day 7 as follows:~% change = (Baseline Pain Intensity - Daily pain intensity at treatment visit) / Baseline Pain Intensity × 100~The threshold values represent an improvement in ongoing pain intensity greater than 20, 30, 40, 50, 60, 70, 80 or 90% as per calculation.~Participants who showed a worsening in their daily pain intensity or who prematurely discontinued the trial were regarded as non-responders in terms of the respective treatment."|Day 7 (end of double blind treatment)||||participants|||Number
2670541|NCT01485094|Primary|The Difference Between Baseline and End-of-double-blind Treatment Brush-evoked Pain Intensity Scores|"The difference between baseline and end-of-double-blind treatment brush-evoked pain intensity scores compared to placebo on a 0-100 point NRS (measured as part of the dynamic mechanical allodynia assessments).~Each participant rated each brush-evoked pain intensity on a 0 to 100 point Numerical Pain Rating Scale, with 0 indicating 'No Pain' and 100 indicating 'most intense pain imaginable'. Lower values compared to an individual subject's baseline are an improvement in symptoms.~The baseline brush-evoked pain intensity score was defined as the average of the geometric mean of all of the values obtained on Day -2 and Day -1, and compared with the scores obtained on day 6 and 7.~For the analysis, only pain scores on days where participants received study drug were considered.~A negative change indicates a decrease in brush-evoked pain intensity from baseline."|Baseline and day 7 (end of double blind treatment)||||units on a scale||Standard Deviation|Mean
2670542|NCT01485094|Primary|Difference Between Baseline and End-of-double-blind Treatment Ongoing Pain Intensity Scores|The baseline pain intensity score was calculated as a mean of pain intensity scores during the Baseline Period (from Day -3 to Day -1). The ongoing pain intensity data from Day-3 to Day 7 was used. For the analysis, only pain scores on days where participants received study drug were considered. The primary efficacy analysis of the ongoing pain intensity score were analyzed in a Bayesian framework, via a mono exponential decay model, with the baseline Numeric Rating Score (NRS) as intercept. Considering the inclusion criteria of baseline pain intensity being in the range from 4 to 9, the range in ongoing pain intensity difference between baseline and end-of-double-blind treatment can be from 6 (worst possible value) to -9 (best possible value). A negative value indicates improvement whilst on the treatment.|Baseline; Day 7 (end of double blind treatment)|Intention-to-treat|||units on a scale||Standard Deviation|Mean
2670543|NCT01485055|Primary|Complete Response Rate Determination|"Complete response was defined as complete resolution of all signs and symptoms of GvHD in all organs using the Modified Glucksberg grading of acute graft versus host disease scale. The score used for GvHD grading complete response was 0 in all evaluable organs."|28 days|The study was closed prematurely as the study sponsor could not supply the medication any further. The study had not enrolled enough subjects to do a valid statistical analysis|||Participants|||Count of Participants
2670544|NCT01484977|Primary|Retention at the End of the 21-week Treatment Period|Retention is a summary measure that integrates both the patient's and clinician's assessment of efficacy and tolerability in epilepsy clinical studies to provide a measure of effectiveness.|Duration of the Treatment Period (21 Weeks)|The primary analysis consists of subjects in the Safety Set (SS). The SS is all subjects who received at least 1 dose of lacosamide.|||percentage of participants|||Number
2670545|NCT01484951|Secondary|Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy|As measured with Goldmann applanation tonometry. The outcome measure was pre-specified for all participants.|Week 8|Per protocol: All participants who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria.|||Percentage of Participants|||Number
2670546|NCT01484951|Primary|Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only)|As measured at baseline and final visit with Goldmann applanation tonometry. The outcome measure was pre-specified for Timolol 0.5% only participants.|Baseline, Week 8|Per protocol: All participants who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria.|||millimeters mercury (mmHg)||Standard Deviation|Mean
2670606|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in mGFR|mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 m^2 body surface area.|Day 43 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in mGFR.|||fold change||90% Confidence Interval|Geometric Mean
2670548|NCT01484938|Primary|Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30|Percentage corneal staining was assessed by the investigator for each of five regions of the cornea; i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Percentage corneal staining was recorded in increments of ten, and the percentages of the five regions were averaged together.|Baseline (Day 0), Day 30|Intent to treat. All subjects who were enrolled in the study and completed at least one on-regimen study visit were evaluable for intent-to-treat analyses.|||Percentage of corneal staining||Standard Deviation|Mean
2670549|NCT01484912|Secondary|Consumption of Short-acting Nitrates||The consumption of short-acting nitrates from baseline (V2, Day 0) to all visits [V3 (Day 14±2), V4 (Day 28±2), V5 (Day 42±2)]according to patient's diary.|The data was not available for analysis, because only two patients administered short-acting nitrates|||mg||Standard Deviation|Mean
2670550|NCT01484912|Secondary|Change in Pharmacological Parameters|The level of oxidative stress parameters (isoprostane, homocysteine), homeostasis parameters (PAI-I activity), inflammatory markers (fibrinogen, hsCRP, soluble CD40 ligand) and cardiac enzymes (CPK-MB and LDH), were measured to assess the pharmacological activity of STA-2.|baseline (visit 2) to week 6 (visit 5)|||||||
2670551|NCT01484912|Secondary|Change in Rate-pressure Product|Rate-pressure product was defined as the product of heart rate and systolic blood pressure, which was measured both at rest and at peak of exercise.|baseline (visit 2) to week 6 (visit 5)|||||||
2670552|NCT01484912|Secondary|Change in Consumption of Short-acting Nitrates|The consumption of short-acting nitrates from baseline (V2, Day 0) to all visits [V3 (Day 14±2), V4 (Day 28±2), V5 (Day 42±2)]according to patient's diary.|from baseline (visit 2) through week 6 (visit 5)|||||||
2670553|NCT01484912|Secondary|Changes in Time to 1mm ST-segment Depression During Exercise Tolerance Testing (ETT).|Time to 1 millimeter (mm) ST-segment depression was recorded from Electrocardiogram (EKG) during exercise tolerance testing (ETT). The 1mm ST-segment depression may be seen in typical angina patient. It means the ST segment of EKG wave drops at least 1 mm compared to the beginning of EKG measurement.|baseline (visit 2) through week 6 (visit 5)||||seconds||Standard Deviation|Mean
2670554|NCT01484912|Primary|Change in Total Exercise Time|Total exercise time was defined as the maximal duration of exercise which was performed by the patient in the setting of exercise tolerance tests (ETT). A 12-lead electrocardiogram (EKG) was used to continuously monitor vital signs. Patients were asked to complete 9-12 minutes of exercise or to exercise until 85% of the maximum predicted heart rate was reached. All exercise tolerance tests used a standard Bruce multistage exercise test protocol.|baseline (visit 2) and week 6 (visit 5)||||seconds||Standard Deviation|Mean
2670555|NCT01484873|Secondary|Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life)|Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks|baseline, 50 weeks||||minutes||95% Confidence Interval|Mean
2670556|NCT01484873|Secondary|Insulin Secretion (Area Under the Curve)|Change in insulin secretion from baseline|baseline, 50 weeks||||120 min*uU/mL x||95% Confidence Interval|Mean
2670557|NCT01484873|Secondary|Visual Analogue Scales for Post-meal Satiety|Change in visual analogue scales scores from baseline to 50 weeks. Higher score indicates greater satiety (minimum 0, maximum 100).|baseline, 50 weeks||||mm||95% Confidence Interval|Mean
2670558|NCT01484873|Secondary|Resting Energy Expenditure (Kcals Per Day)|Change in resting energy expenditure from baseline to 50 weeks|baseline, 50 weeks|8 patients completed the study but one patient did not have REE data available due to technical difficulties|||kcal/day||95% Confidence Interval|Mean
2670559|NCT01484873|Primary|Body Weight (kg)|Change in body weight from baseline to end of study|baseline, 50 weeks|Patients that completed the study|||kg||95% Confidence Interval|Mean
2670560|NCT01484834|Secondary|Pain Perception|"Pain perception were evaluated by the diagram of pain proposed by Corlett in 1995. The part of body which had pain were indicated by the participant. The data were analysed as yes or no and reported as Odds ratio."|The participants were followed for 3 months||||Odds Ratio||95% Confidence Interval|Number
2670561|NCT01484834|Secondary|Changes in Disease Prevalence|the changes in disease prevalence was measured in the same instrument QVS-80. The chronic disease was self-related by the participants.|The participants were followed for 3 months||||participants||95% Confidence Interval|Number
2670562|NCT01484834|Secondary|Occupational Environment|The occupational environment was assessed by the quality of life questionnaire. (QVS-80). It considers physical aspects like accessibility and psycologic aspects such as stress. The domain consists of 11 questions about occupational environment. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).|The participants were followed for 3 months||||units on a scale 0-100||Standard Deviation|Median
2670563|NCT01484834|Secondary|Physical Activity Level|The level of physical activity was evaluated by the questionnaire of quality of life. (QVS-80). The physical activity domain is composed of 15 questions considering the ammount of physical activity practiced during leisure time. The instrument is structured in 5 points Lickert Scale. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).|The participants were followed for 3 months||||units on a scale||Standard Deviation|Median
2670564|NCT01484834|Primary|Quality of Life|The instrument contains 80 questions, of which 67 were structured in 5 points Lickert Scale. QVS-80 has four domains: Health Domain (Health) Physical activity (PA), occupational environment domain (AO) and perception of QoL (QOL). The health domain is composed of 30 questions, and the thirteen initial questions refer to history of the existence of chronic diseases such as hypertension, diabetes, obesity, dyslipidemias, bronchitis, allergic rhinitis and cancer; the remaining questions relate to lifestyle and living habits, such as quality of sleep, smoking and consumption of alcohol. The domain of physical activity consists of 15 questions on physical activity. The Domain workplace consists of 11 questions about the physical activity at work and occupational environment. The Domain perception of QoL consists of 24 questions about personal characteristics, and autonomy. The syntax of QVS-80 put the results in a scale of 0 -100 points (the higher the better).|The participants were followed for 3 months||||units on a scale||Standard Deviation|Median
2670692|NCT01483924|Secondary|Efficacy of APO805K1 as Assessed by Achievement of PASI-75|The proportion of patients in each treatment group who achieved at least a 75% improvement in PASI score from baseline at Week 12|12 weeks|The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.|||percentage of patients|||Number
2670565|NCT01484652|Primary|SPID48 (Summed Pain Intensity Difference)|Pain intensity (PI) is measured using the 11-point (0-10) Numeric Pain Rating Scale (NPRS) score. PID is the arithmetic difference in NPRS score at the time point of interest from the baseline score. SPID48 is the sum of time-weighted PID scores measured 22 times over the 48 hour assessment period, with a total score ranging from -480 (worst) to 480 (best). A higher SPID value indicates greater pain relief.|48 hours|The analysis population for the primary outcome measure was the modified intent-to-treat population (mITT). The mITT analysis population includes 303 subjects from Cohort 2. Missing pain intensity difference scores were imputed using a multiple imputation method.|||scores on a scale||Standard Error|Mean
2670566|NCT01484626|Primary|Number of Patients Experiencing a Toxicity|The number of patients experiencing at least one toxicity at the lowest dose of bendamustine. A toxicity is defined as one or more of the following: Upper respiratory infection; anemia; thrombocytopenia; neutropenia; shortness of breath on exertion; decreased appetite; nausea; neuropathy; anxiety; arthritis; and hypercalcemia.|21 days|No patients were analyzed as study was terminated early after external sponsor withdrew support. Therefore, data necessary for planned analyses were not collected.|||Participants|||Count of Participants
2670567|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 HAQ-DI Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Day 43 of Period 1, Day 29 of Period 2|FAS|||score on a scale||Standard Error|Least Squares Mean
2670568|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline HAQ-DI Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Day 1 of Period 1, Day 29 of Period 2|FAS|||score on a scale||Standard Error|Least Squares Mean
2670569|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) Score|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Day 1 of Period 1, Day 43 of Period 1|FAS|||score on a scale||Standard Error|Least Squares Mean
2670570|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in Patient Assessment of Arthritis Pain|Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Day 43 of Period 2, Day 29 of Period 2|FAS|||mm||Standard Error|Least Squares Mean
2670571|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in Patient Assessment of Arthritis Pain|Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Day 1 of Period 1, Day 29 of Period 2|FAS|||mm||Standard Error|Least Squares Mean
2670572|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Patient Assessment of Arthritis Pain|Participant's assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.|Day 1 of Period 1, Day 43 of Period 1|FAS|||mm||Standard Error|Least Squares Mean
2670573|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in Physician Global Assessment of Arthritis|A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.|Day 43 of Period 1, Day 29 of Period 1|FAS|||mm||Standard Error|Least Squares Mean
2670574|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in Physician Global Assessment of Arthritis|A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.|Day 1 of Period 1, Day 29 of Period 2|FAS|||mm||Standard Error|Least Squares Mean
2670575|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Physician Global Assessment of Arthritis|A physician assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination. The physician's response was recorded using a 100 mm VAS, where 0 mm = very good and 100 mm = very poor.|Day 1 of Period 1, Day 43 of Period 1|FAS|||mm||Standard Error|Least Squares Mean
2670576|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in PGAA|"Participants answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The participants responses were recorded using a 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Day 43 of Period 1, Day 29 of Period 2|FAS|||mm||Standard Error|Least Squares Mean
2670577|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in PGAA|"Participants answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The participants responses were recorded using a 100 mm VAS, where 0 mm = very well and 100 mm = very poorly."|Day 1 of Period 1, Day 29 of Period 2|FAS|||mm||Standard Error|Least Squares Mean
2670578|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Patient Global Assessment of Arthritis (PGAA)|"Participants answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 millimeter (mm) visual analog scale (VAS), where 0 mm = very well and 100 mm = very poorly."|Day 1 of Period 1, Day 43 of Period 1|FAS|||mm||Standard Error|Least Squares Mean
2670582|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in Swollen Joint Count|Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 43 of Period 1, Day 29 of Period 2|FAS|||swollen joints||Standard Error|Least Squares Mean
2670583|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in Swollen Joint Count|Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 1 of Period 1, Day 29 of Period 2|FAS|||swollen joints||Standard Error|Least Squares Mean
2670584|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Swollen Joint Count|Swollen joint count included 66 joints. Assessor assessed joints for swelling using the following scale: present/absent/not done/not applicable (to be used for artificial joints). Joints assessed included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 1 of Period 1, Day 43 of Period 1|FAS|||swollen joints||Standard Error|Least Squares Mean
2670585|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in Tender/Painful Joint Count|68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (hip, knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 43 of Period 1, Day 29 of Period 2|FAS|||tender/painful joints||Standard Error|Least Squares Mean
2670586|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in Tender/Painful Joint Count|68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb IP, PIP, and DIP), and lower extremity (hip, knee, ankle, tarsus, MTP, great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 1 of Period 1, Day 29 of Period 2|FAS|||tender/painful joints||Standard Error|Least Squares Mean
2670587|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline in Tender/Painful Joint Count|68 joints were assessed by a joint assessor to determine the number of joints that were considered tender or painful Assessed joints included: upper body (temporomandibular, sternoclavicular, acromioclavicular), upper extremity (shoulder, elbow, wrist, MCP, thumb interphalangeal [IP], PIP, and distal interphalangeals [DIP]), and lower extremity (hip, knee, ankle, tarsus, metatarsophalangeals [MTP], great toe IP, proximal and distal interphalangeals combined [PIP]).|Day 1 of Period 1, Day 43 of Period 1|FAS|||tender/painful joints||Standard Error|Least Squares Mean
2670588|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 DAS28-4 (CRP)|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 43 of Period 1, Day 29 of Period 2|FAS|||score on a scale||Standard Error|Least Squares Mean
2670589|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline DAS28-4 (CRP)|DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 1 of Period 1, Day 29 of Period 2|FAS|||score on a scale||Standard Error|Least Squares Mean
2670590|NCT01484561|Secondary|LS Mean Change at End of Period 1 From Baseline DAS28-4 (CRP)|DAS28 calculated from the number of SJC and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 1 of Period 1, Day 43 of Period 1|FAS|||score on a scale||Standard Error|Least Squares Mean
2670591|NCT01484561|Secondary|LS Mean Change at End of Period 2 From End of Period 1 in DAS28-3 (CRP)|DAS28 calculated from the tender/painful joint count, SJC using the 28 joints count, and CRP value. DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 43 of Period 1, Day 29 of Period 2|FAS|||score on a scale||Standard Error|Least Squares Mean
2670592|NCT01484561|Secondary|LS Mean Change at End of Period 2 From Baseline in DAS28-3 (CRP)|DAS28 calculated from the tender/painful joint count, SJC using the 28 joints count, and CRP value. DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Day 1 of Period 1, Day 29 of Period 2|FAS|||score on a scale||Standard Error|Least Squares Mean
2670593|NCT01484561|Secondary|Least Squares (LS) Mean Change at End of Period 1 From Baseline in Disease Activity Score Based on 28-Joint Count CRP (DAS28-3 [CRP])|DAS28 calculated from the tender/painful joint count, swollen joint count (SJC) using the 28 joints count, and CRP value. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Day 1 of Period 1, Day 43 of Period 1|FAS|||score on a scale||Standard Error|Least Squares Mean
2670594|NCT01484561|Secondary|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response|ACR70 response: ≥70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant' assessment of functional disability via a HAQ, and 5) CRP at each visit.|Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2|FAS (NRI, LOCF)|||percentage of participants|||Number
2670595|NCT01484561|Secondary|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response|ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a HAQ, and 5) CRP at each visit.|Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2|FAS (NRI, LOCF)|||percentage of participants|||Number
2670596|NCT01484561|Secondary|Percentage of Participants Achieving an American College of Rheumatology 20% (ACR20) Response|ACR20 response: greater than or equal to (≥)20 percent (%) improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).|Day 1 of Period 1 to Day 43 of Period 1, Day 1 of Period 1 to Day 29 of Period 2|FAS, missing values while participant was still enrolled utilized last observation carried forward (LOCF) imputation while participants with missing values after a participant was discontinued from study participation (for any reason) were considered to be nonresponders (nonresponder imputation [NRI])|||percentage of participants|||Number
2670597|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in Serum Creatinine|Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in mg/dL reported by the central laboratory were used.|Day 43 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in serum creatinine.|||fold change||90% Confidence Interval|Geometric Mean
2670598|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change From End of Period 2 From Baseline in Serum Creatinine|Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in mg/dL reported by the central laboratory were used. Baseline for serum creatinine was defined as the mean of values obtained at screening and predose on Day 1 of Period 1.|Day 1 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in serum creatinine.|||fold change||90% Confidence Interval|Geometric Mean
2670599|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Serum Creatinine|Blood samples were collected from participants at screening, predose on Day 1 of Period 1, on the last day of Period 1 and on the last day of Period 2 for assessment of serum creatinine levels. Serum creatinine values in milligrams per deciliter (mg/dL) reported by the central laboratory were used. Baseline for serum creatinine was defined as the mean of values obtained at screening and predose on Day 1 of Period 1.|Day 1 of Period 1, Day 43 of Period 1|FAS OC; one participant was excluded (took wrong treatment) from the FAS analysis of change at end of Period 1 from baseline in serum creatinine.|||fold change||90% Confidence Interval|Geometric Mean
2670600|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using the Cockcroft-Gault Equation|eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area.|Day 43 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in eGFR (Cockcroft-Gault).|||fold change||90% Confidence Interval|Geometric Mean
2670601|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using the Cockcroft-Gault Equation|eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in eGFR (Cockcroft-Gault).|||fold change||90% Confidence Interval|Geometric Mean
2670602|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in eGFR Using the Cockcroft-Gault Equation|eGFR was calculated using the Cockcroft-Gault equation normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 43 of Period 1|FAS OC; one participant was excluded (took wrong treatment) from the FAS analysis of change at end of Period 1 from baseline in eGFR (Cockcroft-Gault).|||fold change||90% Confidence Interval|Geometric Mean
2670603|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From End of Period 1 in eGFR Using MDRD|eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m^2 body surface area.|Day 43 of Period 1, Day 29 of Period 2|FAS (OC); three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from end of Period 1 in eGFR (MDRD).|||fold change||90% Confidence Interval|Geometric Mean
2670604|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 2 From Baseline in eGFR Using MDRD|eGFR was calculated using the MDRD equation with eGFR values normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in eGFR (MDRD).|||fold change||90% Confidence Interval|Geometric Mean
2670605|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at End of Period 1 From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using Modified Diet in Renal Disease (MDRD)|eGFR was calculated using the MDRD equation and normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Screening and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 43 of Period 1|FAS (OC); one participant was excluded (took wrong treatment) from the FAS analysis of change at end of Period 1 from baseline in eGFR (MDRD).|||fold change||90% Confidence Interval|Geometric Mean
2670730|NCT01483378|Primary|Answers to Survey Questions|All enrolled patients completed a survey of baseline characteristics, eligibility for the herpes zoster vaccine, and attitudes regarding herpes zoster vaccination. The survey results from patients who agreed to receive the herpes zoster vaccine were compared to the results of patients who declined to be vaccinated.|January 9, 2012 to February 12, 2012||||Percentage of responders||95% Confidence Interval|Number
2670607|NCT01484561|Secondary|Adjusted Geometric Mean-Fold Change at the End of Period 2 From Baseline in mGFR|mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 m^2 body surface area. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 29 of Period 2|FAS OC; three participants were excluded (took wrong treatment) from the FAS analysis of change at end of Period 2 from baseline in mGFR.|||fold change||90% Confidence Interval|Geometric Mean
2670608|NCT01484561|Primary|Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR)|Glomerular filtration rate (GFR) is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. mGFR was determined using iohexol serum clearance using compartmental modeling of the iohexol serum concentration-time data. mGFR values were normalized to 1.73 meters squared (m^2) body surface area. A normal GFR is greater than (>)90 milliliters per minute (mL/min), although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 mL/min is consistent with kidney failure. Baseline was defined as the mean of the values obtained at Run-in and on predose in Period 1/Day 1.|Day 1 of Period 1, Day 43 of Period 1|Full Analysis Set (FAS): all randomized participants who received at least 1 dose of the test article (CP-690,550 or placebo). Observed Case (OC): missing data were not imputed. One participant was excluded (took wrong treatment) from FAS analysis of change at end of Period 1 from baseline in mGFR.|||fold change||90% Confidence Interval|Geometric Mean
2670609|NCT01484496|Secondary|Percentage of Par. Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Par. Receiving Greater Than 7.5 mg/Day at Baseline|For the analysis of steroid use, all steroid dosages were converted to a prednisone equivalent in mg. The average daily prednisone dose was calculated taking into account all steroids taken intravenously, intramuscularly, SC, intradermally and orally for both SLE and non-SLE reasons. A responder was defined as having a prednisone reduction by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52. At Baseline, the average daily prednisone dose was the sum of all prednisone doses over 7 consecutive days up to, but not including Day 0, divided by 7. For this analysis, the average prednisone dose was the total prednisone dose during weeks 40 through 52 divided by the number of days during Weeks 40 through 52. Analysis was performed using a logistic regression model with covariates treatment group, Baseline prednisone dose, Baseline SELENA SLEDAI score, (<=9 vs >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).|Baseline (Day 0, prior to dosing), Weeks 40 through Week 52|ITT population. Only par. with Baseline prednisone dose >7.5 mg/day were included.|||Percentage of par.|||Number
2670610|NCT01484496|Secondary|Time to First Severe Flare (as Measured by the Modified SLE Flare Index)|Time to first severe SLE flare is defined as the number of days from treatment start date until the participant met an event (event date - treatment start date +1). Analyses of severe SLE flare was performed on modified SELENA SLEDAI SLE flare index that excludes severe flares that were triggered only by an increase in SELENA SLEDAI score to >12 (since this may only represent a modest increase in disease activity). Only post-baseline severe flares were considered.|Baseline (Day 0, prior to dosing) to Week 52|ITT population. Only those participants available at that particular timepoints were analyzed.|||Days||Full Range|Median
2670611|NCT01484496|Primary|Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52|SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of <0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (<=9 vs. >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).|Week 52|Intention-To-Treat (ITT) Population: comprised of all par. who were randomized and treated with at least one dose of study treatment. Three par. did not have a Baseline PGA assessment; therefore, were not included.|||Percentage of par.|||Number
2670612|NCT01484431|Secondary|Number of Participants With Palatability of the Tadalafil Suspension|"The Taste Assessment Questionnaire (TAQ) questions were:~TAQRES1: Please rate the bitterness level. TAQRES2: Please rate the sweetness level. TAQRES3: Please rate the aftertaste. TAQRES4: Please rate the overall acceptability of the taste for daily use."|Day 35 (high dose)|Participants who received at least one oral suspension dose of study drug in the Light-weight cohort (≥2 years of age). Per protocol, palatability of the tadalafil suspension was evaluated in the Light-weight cohort only.|||Participants|||Count of Participants
2670613|NCT01484431|Secondary|Percentage of Participants With Clinical Worsening|Clinical worsening was defined as any of the following: death, lung or heart transplantation, atrial septostomy or Potts' shunt, hospitalization for Pulmonary Arterial Hypertension (PAH) progression, new onset syncope, initiation of new PAH therapy (including increase in the dose of existing PAH specific concomitant therapy, such as endothelin receptor agonist or beraprost medication), or increase of 1 or more in World Health Organization(WHO) Functional Class (except for participants already in Class IV; only for participants unable to perform the 6 minute walk (6MW) test; worsening of WHO functional class by 1 or more for participants who can perform a 6 minute walk (6MW) test and who have a decrease of ≥ 20% in the 6 minute walk distance (for those participants who are ≥6 years of age).|Baseline Up to 27 Months|All participants who received at least one dose of study drug.|||percentage of participants|||Number
2670614|NCT01484431|Primary|Population Pharmacokinetics: Average Concentration (Cmean,ss) of for Tadalafil at Steady-State.|"Population Pharmacokinetics: Average Concentration (Cmean,ss) of for tadalafil at steady-state.~The measure of dispersion reported is 90% Prediction Intervals and not Confidence Intervals."|Period 1: Pre Dose and 2, 4, 8, 12, and 24 Hours Post Dose on Days 1, 14 and 49; with single dose measures on Day 1 and steady-state measurements on Days 14 and 49|All participants who received at least one dose of study drug and had evaluable PK data including all dose levels on Day 1, 14 and 49. Per protocol, the summary reflects potential exposure of the high dose within each weight cohort|||nanograms per milliliter (ng/mL)||90% Confidence Interval|Median
2671528|NCT01475513|Secondary|Change From Baseline in Acute Insulin Response to Glucose|Acute Insulin Response to Glucose values obtained from FSIVGTT models--higher values indicate better insulin response|Baseline, 6 months||||mIU* L^-1 * min||95% Confidence Interval|Mean
2670615|NCT01484431|Primary|Population Pharmacokinetics: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau) for Tadalafil|"Population Pharmacokinetics: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau) for Tadalafil.~The measure of dispersion reported is 90% Prediction Intervals and not Confidence Intervals."|Period 1: Pre Dose and 2, 4, 8, 12, and 24 Hours Post Dose on Days 1, 14 and 49; with single dose measures on Day 1 and steady-state measurements on Days 14 and 49|All participants who received at least one dose of study drug and had evaluable PK data including all dose levels on Day 1, 14 and 49. Per protocol, the summary reflects potential exposure of the high dose within each weight cohort|||nanograms* hour per milliliter(ng*hr/mL)||90% Confidence Interval|Median
2670616|NCT01484340|Secondary|Smoking Status (COppm)|A point of care test for measuring CO will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 7ppm will indicate abstinence.|12 months from baseline|As treated analysis: Patients without biochemical verification at any visit were excluded from the denominator. Counseling only arm: 72 patients excluded. Nicotine Replacement Therapy +counseling arm: 74 patients excluded.|||COppm||Inter-Quartile Range|Median
2670617|NCT01484340|Secondary|Smoking Status (COppm)|A point of care test for measuring CO will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 7ppm will indicate abstinence.|2 months from baseline|As treated analysis: Patients without biochemical verification at any visit were excluded from the denominator. Counseling only arm: 64 patients excluded. Nicotine Replacement Therapy +counseling arm: 60 patients excluded.|||COppm||Inter-Quartile Range|Median
2670618|NCT01484340|Primary|Smoking Status Using a Point of Care Test for Measuring Cotinine|A point of care urine test for measuring cotinine will also be conducted via the SmokeScreen® test from GFC Diagnostics Ltd. to verify smoking status. A reading of < 0.4 μg/ml cotinine equivalent will indicate abstinence.|6 months from baseline|As treated analysis: Patients without biochemical verification at any visit were excluded from the denominator. Counseling only arm: 53 patients excluded. Nicotine Replacement Therapy +counseling arm: 54 patients excluded.|||μg/ml cotinine equivalent||Inter-Quartile Range|Median
2670619|NCT01484340|Primary|Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)|A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 7ppm will indicate abstinence.|6 months from baseline|As treated analysis: Patients without biochemical verification at any visit were excluded from the denominator. Counseling only arm: 53 patients excluded. Nicotine Replacement Therapy +counseling arm: 54 patients excluded.|||COppm||Inter-Quartile Range|Median
2670620|NCT01484314|Secondary|Incidence of Grade 3/4 Thrombocytopenic Events|To assess whether eltrombopag decreases the incidence of grade 3/4 thrombocytopenic events by day 1 of Cycle 3 of chemotherapy|2 years|Terminated with 1 patient enrolled; no data due to patient privacy.||||||
2670621|NCT01484314|Primary|Safety and Tolerability|To determine whether eltrombopag administration results in an increased number of participants with adverse events.|2 years|Terminated with 1 patient enrolled; no data due to patient privacy.||||||
2670622|NCT01484314|Primary|Maintenance of Platelet Count|To determine the proportion of patients with relapsed multiple myeloma in whom eltrombopag maintains platelet counts at > 90% of baseline platelet counts with no more than 4 units of platelet transfusions at day 1 of Cycle 3 of chemotherapy|2 years|Terminated with 1 patient enrolled; no data due to patient privacy.||||||
2670623|NCT01484275|Secondary|Overall Survival (OS)|OS is defined as the time between randomization and death due to any cause.|Up to 4.7 Years|ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS.|||Days||95% Confidence Interval|Median
2670624|NCT01484275|Secondary|Number of Participants With Best Response to First Subsequent Multiple Myeloma Treatment|Best response to first subsequent anti-myeloma therapy was assessed by physician report at 6-month intervals and classified as: complete response (CR) (negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and < 5% plasms cells (PCs) in bone marrow); stringent CR (CR plus a normal FLC ratio, absence of clonal cells in bone marrow); near CR (< 5% PCs in a bone marrow aspirate, no increase in lytic bone lesions); very good partial response (VGPR) (serum and urine component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour); partial response (PR): >= 50 reduction of serum M-protein, reduction in 24-hour urinary M-protein by >=90 % or to < 200 mg/24 hours); minimal response (>=25% but <= 49% reduction of serum M-protein and reduction in urine M-protein by 50%-89%); stable disease (not meeting criteria for CR, VGPR, PR, or PD); PD; not evaluable and unknown.|Up to 4.7 Years|The data was not collected and analyzed for this outcome measure as per the change in planned analysis.||||||
2670625|NCT01484275|Secondary|Number of Participants With Symptomatic Multiple Myeloma With Adverse Prognostic Features|Number of participants who progressed to symptomatic multiple myeloma with stage III of International Staging System (ISS) or abnormal cytogenetic findings were assessed. The ISS system consists of stage I: beta2-microglobulin < 3.5 milligram per liter (mg/L) and albumin >= 3.5 gram (g)/100 ml; stage II: neither stage I nor stage III and stage III: beta2-microglobulin >= 5.5 mg/L.|Up to 4.7 Years|The data was not collected and analyzed for this outcome measure as per the change in planned analysis.||||||
2670626|NCT01484275|Secondary|Time to Worsening in the Brief Pain Inventory (BPI) Worst Item Scores|"Time to worsening in the BPI worst item is defined as the time between randomization and the first documentation of a worsening in the BPI worst item. It has 2 domains reflecting pain severity and pain interference with domains of functioning and well-being. The selected item refers to the worst pain the patient has experienced over the past 24 hours. This item has been found to be most responsive to interference with key domains of functioning and well-being and may be used as a single item. Responses are provided on an 11-point numeric rating scale ranging from 0 no pain to 10 pain as bad as you can imagine. Responses are described as mild (1 to 4), moderate (5 to 6) and severe (7 to 10). Worsening in the BPI worst item is defined as 2 points increase from baseline."|Up to 4.7 Years|ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS.|||Days||95% Confidence Interval|Median
2670627|NCT01484275|Secondary|Time to Worsening in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) Scale Score|"Time to worsening in EORTC-QLQ-C30 (physical function scale) is defined as time between randomization and first documentation of a worsening in EORTC-QLQ-C-30. Worsening in the EORTC-QLQ-C30 is defined as 10 points decrease from baseline. It comprises module with 30 items. Questionnaire includes 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, nausea/vomiting), a global health and quality of life scale, and a number of single items assessing symptoms (dyspnea, loss of appetite, insomnia, constipation, diarrhoea). Instrument contains 28 items using a Likert scale with 4 response options: Not at All, A Little, Quite a Bit, Very Much (scored 1-4). Two additional items use response options (1-7): 1=Very Poor, to 7=Excellent. All scale and item scores were linearly transformed to be in range from 0-100. A higher score represents a higher (better) level of functioning, or a higher (worse) level of symptoms."|Up to 4.7 Years|ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS who had 10 points decrease from baseline in the physical function scale.|||Days||Full Range|Median
2670628|NCT01484275|Secondary|Percentage of Participants With Serum M-protein Response|Serum M-protein response is defined as a decrease of greater than or equal to (>=) 50% in serum M-protein compared with baseline at 2 consecutive assessments.|Up to 4.7 Years|ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS.|||Percentage of participants||95% Confidence Interval|Number
2670629|NCT01484275|Secondary|Progression-Free Survival|PFS is defined as the time between randomization and initial documented PD according to the CRAB - International Myeloma Working Group (IMWG) criteria or date of death, whichever occurs first. PD is defined as presence of an M-component in serum plus clonal plasma cells in the bone marrow plus 1 or more of the following: Calcium elevation (> 11.5 mg/dL [> 2.88 mmol/L]); Renal insufficiency (creatinine > 2 mg/dL [177 [micro mol/L or more]); Anemia (<10 g/dL or 2 g/dL) lower than LLN) [hemoglobin < 6.5 mmol/L or 1.25 mmol/L lower than LLN]); Bone disease (lytic lesions or osteopenia).|Up to 4.7 Years|ITT population included participants who were randomly assigned to siltuximab or placebo treatment group based on an IVRS.|||Days||95% Confidence Interval|Median
2670630|NCT01484275|Secondary|Progressive Disease Indicator Rate (PDIR) at 6 Months|PDIR is defined as percentage of participants who meet any of following criteria occurring within 6 months of start of treatment. a) CRAB criteria: true progression events, b) Serum M-protein: increase by 25 % compared with baseline at 2 consecutive assessments, c) Magnetic resonance imaging: unequivocal increase in focal bone lesions, d) Immunoparesis: decrease by 25% compared with baseline of 2 other non-affected immunoglobulin (Ig) (IgG, IgM, IgA) at 2 consecutive assessments, e) Hemoglobin: decrease of 1.5 g/dL (with at least 1 read below LLN) at 2 consecutive assessments, with no other identifiable cause. PD is defined as presence of M-component in serum plus clonal plasma cells in bone marrow plus 1 or more of following: Calcium elevation (> 11.5 mg/dL [> 2.88 mmol/L]); Renal insufficiency (creatinine >2 mg/dL [177 micro mol/L or more]); Anemia (hemoglobin <10 or 2 g/dL lower than LLN) [hemoglobin < 6.5 or 1.25 mmol/L lower than LLN]); Bone disease (lytic lesions or osteopenia).|At 6 Months|Response evaluable population included participants who had a diagnosis of high-risk smoldering multiple myeloma (SMM) and received at least 1 dose of siltuximab/placebo treatment. In addition, participants were to have at least 1 post-baseline disease assessment.|||Percentage of participants||95% Confidence Interval|Number
2670631|NCT01484275|Primary|One-Year Progression-Free Survival (PFS) Rate|One-year PFS rate is defined as the percentage (%) of participants surviving 1 year after randomization without progression to multiple myeloma or death estimated by the Kaplan-Meier method and based on the International Myeloma Working Group (IMWG) calcium, renal, anemia, and bone lesions (CRAB) criteria. Progressive disease (PD) is defined as presence of an M- component in serum plus clonal plasma cells in the bone marrow plus 1 or more of the following: Calcium elevation (greater than [>] 11.5 milligram per deciliter [mg/dL] [> 2.88 millimoles per liter {mmol/L}]); Renal insufficiency (creatinine > 2 mg/dL [177 micromoles per liter or more]; Anemia (hemoglobin less than [<] 10 gram per deciliter [g/dL] or 2 g/dL lower than lower limit of normal [LLN] [hemoglobin < 6.5 mmol/L or 1.25 mmol/L lower than LLN]); Bone disease (lytic lesions or osteopenia).|Up to 1 Year|Intent-to-treat (ITT) population included participants who were randomly assigned to siltuximab or placebo treatment group based on an integrated voice response system (IVRS).|||Percentage of participants||95% Confidence Interval|Number
2670632|NCT01484197|Secondary|Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h)||Day 1, Day 7|PK Analysis Set|||hour*pg/mL||Standard Deviation|Mean
2670633|NCT01484197|Secondary|Observed Maximum Concentration (Cmax) After Drug Administration||Day 1, Day 7|PK Analysis Set|||pg/mL||Standard Deviation|Mean
2670634|NCT01484197|Secondary|Time to Reach Maximum Concentration (Tmax) After Drug Administration||Day1, Day 7|PK Analysis Set|||Hours||Full Range|Median
2670635|NCT01484197|Secondary|Number of Participants With Adverse Events as a Measure of Safety|Adverse event are defined as any unfavorable and unintended diagnosis, symptoms, sign (including an abnormal lab finding), syndrome or disease which either occurs during the study, having been absent at baseline, or if present at baseline appear to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization , cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards. Additional information about adverse events can be found in the Adverse Event section|Up to 101 days|Safety population inlcuded all participants who received at least one dose of study drug.|||Participants|||Number
2670636|NCT01484197|Secondary|Number of Puffs of Rescue Medicine|Salbutamol (100 µg/puff) was used as rescued medicine. The total number of puffs per day was calculated and divided by the number of days with data to determine the mean daily number of puffs of rescue medication for each patient and was recorded in the patient diary from Baseline until Day 8 of Treatment Period 4. Analysis of covariance with treatment, period, sequence, and subject nested within sequence as fixed effect.|Up to 101 days|Participants in the Pharmacodynamics Analysis set (included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement) who used rescue medication.|||Puffs/day||90% Confidence Interval|Least Squares Mean
2670637|NCT01484197|Secondary|Peak Expiratory Flow Rate in the Morning in the Evening|PEFR was measured on all days from Screening Visit 2 to end of study visit: twice daily pre-dose (prior to Inhaled Corticosteroids) and approximately 12 hours post-dose (during the treatment period). Each subject was provided with a PEFR meter and recorded the PEFR readings in a daily diary. repeated measures. Analysis of covariance with treatment, period, sequence, day and treatment-day interaction as fixed effect and subject as a random effect and baseline PEFR as a covariate in the model.|Up to 101 days|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.|||Liters per second||Standard Error|Least Squares Mean
2670638|NCT01484197|Secondary|Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h)|Spirometry was conducted according to internationally accepted standards at predose, 5 , 15 and 30 min, 1, 2, 4, 8 and 12 hours post-dose on Day 1 and Day 7. The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 12 h post. Analysis of covariance with treatment, period, sequence and subject nested within sequence as fixed effects and FEV1 period baseline as a covariate.|Day 1, Day 7|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.|||Liters||90% Confidence Interval|Least Squares Mean
2670639|NCT01484197|Secondary|Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h)|Spirometry was conducted according to internationally accepted standards at predose, 5, 15 and 30 minutes, 1, 2 and 4 hours post-dose on Day 1 and Day 7. The standardized (with respect to the length of time) area under the curve (AUC) for FEV1 was calculated using trapezoidal rule between 5 min and 4 h post. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.|Day 1, Day 7|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.|||Liters||90% Confidence Interval|Least Squares Mean
2670640|NCT01484197|Secondary|Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.|Day 7, Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement|||Liters/second||Standard Deviation|Mean
2670641|NCT01484197|Secondary|Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.|Day 1, Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement|||Liters/second||Standard Deviation|Mean
2670642|NCT01484197|Secondary|FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2 after treatment. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.|Day 7, Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.|||Ratio||Standard Deviation|Mean
2670643|NCT01484197|Secondary|FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FEV1/FVC ratio is the percentage of the total FVC that is expelled from the lungs during the first second of forced exhalation.|Day1, Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement|||Ratio||Standard Deviation|Mean
2670644|NCT01484197|Secondary|Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.|Day 7, Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement|||Liters||Standard Deviation|Mean
2670645|NCT01484197|Secondary|Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8 and 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.|Day 1, Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement|||Liters||Standard Deviation|Mean
2670646|NCT01484197|Secondary|FEV1 at Each Time-Point on Day 7 and Day 8|Spirometry was conducted according to internationally accepted standards at 0, 15 and 30 minutes; 1,2,3,4,8,12 hours on Day 7 and 23.16 and 23.75 hours on Day 8. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Day 7, Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement|||Liters||Standard Deviation|Mean
2670647|NCT01484197|Secondary|FEV1 at Each Time-Point on Day 1 and Day 2|Spirometry was conducted according to internationally accepted standards post-dose at 0, 15 and 30 minutes; 1, 2, 3, 4, 8, 12 hours on Day 1 and 23.16 and 23.75 hours on Day 2. FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.|Day 1, Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement|||Liters||Standard Deviation|Mean
2670648|NCT01484197|Secondary|Time to Peak FEV1 at Day 1 and Day 7|Spirometry was performed according to internationally accepted standards. Time to the peak (maximum) FEV1 is recorded. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.|Day 1, Day 7|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.|||Hours||Full Range|Median
2670649|NCT01484197|Secondary|Peak FEV1 at Day 1 and Day 7|Spirometry was performed according to internationally accepted standards at 0, 15 and 30 minutes; 1,2,3,4,8,12 hours on Day 1 and 23.16 and 23.75 hours on Day 2 after 1 day of treatment and on Day 7 and Day 8 following 7 days of treatment. Peak FEV1 was the maximum FEV1 post treatment. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline included as a covariate.|Day 1, Day 7|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.|||Liters||90% Confidence Interval|Least Squares Mean
2670650|NCT01484197|Secondary|Trough Forced Expiratory Volume in One Second (FEV1) After 1 Day of Treatment|Spirometry was performed according to internationally accepted standards at Day 2. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose at Day 2. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.|Day 2|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.|||Liters||Standard Error|Least Squares Mean
2670651|NCT01484197|Primary|Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment|Spirometry was performed according to internationally accepted standards at Day 8. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose.at Day 8. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.|Day 8|Pharmacodynamics Analysis set included all participants that received at least one dose of study drug and had baseline and at least one post-baseline FEV1 measurement.|||Liters||Standard Error|Least Squares Mean
2670652|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the Second Dental Treatment|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG - 1)/(SG - 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 14 days after the second dental treatment minus BPA at baseline. The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 14 days after the second dental treatment (The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment.)|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 15 subjects who had BPA at 14 days after the second dental treatment were used.|||ng/mL||Standard Deviation|Mean
2670653|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the Second Dental Treatment|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG - 1)/(SG - 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 1 day after the second dental treatment minus BPA at baseline. The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 1 day after the second dental treatment (The second dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically 3-4 weeks after the first dental treatment.)|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 26 subjects who had BPA at 1 day after the second dental treatment were used.|||ng/mL||Standard Deviation|Mean
2670654|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 14 Days After the First Dental Treatment|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG - 1)/(SG - 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 14 days after the first dental treatment minus BPA at baseline. The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 14 days after the first dental treatment (The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline.)|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 81 subjects who had BPA at 14 days after the first dental treatment were used.|||ng/mL||Standard Deviation|Mean
2670668|NCT01483963|Secondary|Investigator Assessment of Improvement With Treatment at Day 92|Investigator assessment of degree of improvement in severity of the participant's treated shoulder compared with screening rated as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.|Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||Participants|||Count of Participants
2670910|NCT01480843|Primary|Change in Frequency of Hypoglycemia Episodes From Baseline, 5 Months, 8 Months|frequency of hypoglycemia episodes measured by continuous glucose monitoring per 5 days of continuous glucose monitoring data|baseline, 5 months, 8 months|Subject drop outs|||episodes of hypoglycemia||Standard Deviation|Mean
2670655|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 1 Day After the First Dental Treatment|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG - 1)/(SG - 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at 1 day after the first dental treatment minus BPA at baseline. The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 1 day after the first dental treatment (The first dental treatment was scheduled as per treatment needs and the schedules of the dentist and patient. It was typically within a few weeks of baseline.)|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 89 subjects who had BPA at 1 day after the first dental treatment were used.|||ng/mL||Standard Deviation|Mean
2670656|NCT01484132|Primary|Change in Urinary Bisphenol A Level (BPA) From Baseline to 6 Months|BPA was measured, corrected for specific gravity, in ng/mL. We corrected BPA for specific gravity (SG) using the formula: BPA * [(meanSG - 1)/(SG - 1)], where meanSG is the mean of the SG for the samples examined. Urine samples were collected twice pre-treatment and the geometric mean of BPA at each pre-treatment visit was used as the baseline BPA. Change in BPA was computed using BPA at follow-up minus BPA at baseline. Analysis of change in BPA was done using the arithmetic mean.|From Baseline to 6 months|Of 91 subjects who had at least one pre-treatment and at least one post-treatment urine sample, 77 subjects who had BPA at 6 months were used.|||ng/mL||Standard Deviation|Mean
2670657|NCT01484054|Primary|Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire|The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|After 7 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.|||units on a scale||Standard Error|Least Squares Mean
2670658|NCT01484054|Primary|Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire|The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.|After 7 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.|||units on a scale||Standard Error|Least Squares Mean
2670659|NCT01484054|Primary|Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire|The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range from 0-120.|After 7 to 9 days of lens wear|Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.|||units on a scale||Standard Error|Least Squares Mean
2670660|NCT01484041|Secondary|Progression-free Survival|Length of time from study entry until progressive disease|24 weeks|Data not collected for this outcome as study terminated by company prior to completing accrual||||||
2670661|NCT01484041|Secondary|Pharmacodynamic Effects|Expression of pFGFR, pFRS2, pERK in tumor tissue and VEGF, bFGF, PLGF, sVEGFR1/2 and FGF23 levels in plasma|24 weeks|Data were not collected for this outcome||||||
2670662|NCT01484041|Secondary|Number of Participants With Adverse Events|Number of participants experiencing adverse events|24 weeks||||participants|||Number
2670663|NCT01484041|Secondary|Recommended Phase 2 Dose|The dose of dovitinib at which 1 or less subjects experience a dose limiting toxicity when administered every day for 5 days followed by 2 days off schedule in combination with an aromatase inhibitor|4 weeks|Subjects on study evaluated for toxicity|||mg|||Number
2670664|NCT01484041|Primary|Clinical Benefit Rate|Complete response, partial response, or stable disease at 24 weeks from trial entry as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression|24 weeks||||participants|||Number
2670665|NCT01484028|Primary|Corneal Staining of Grade 3 or 4|Corneal staining was graded using a 5-point scale; 0=None(no staining), 1=Trace, 2=Mild, 3=Moderate, and 4=Severe. Only those eyes with corneal staining grade >= 3 were reported.|After 7-9 days of lens wear|Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.|||% of Eyes|eyes|95% Confidence Interval|Number
2670666|NCT01484028|Primary|Lens Fit Acceptance|The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no).|Dispensing|Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.|||% of Eyes|eyes|95% Confidence Interval|Number
2670667|NCT01484028|Primary|Monocular Visual Acuity|Monocular distance Snellen visual acuity (VA) scores were coverted to the algorithm of the minimal angle of resolution (LogMAR) scale based on the following formula: LogMAR = Log10 (VA/20) - a*VAR, where Log10 = base 10 logarithm, VA = the Snellen denominator score, a = LogMAR stepsize coefficient and VAR = letter gained or missing in addition to the Snellen denominator score.|Dispensing|Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.|||LogMAR score|eyes|Standard Deviation|Mean
2670669|NCT01483963|Secondary|Subject Satisfaction With Treatment at Day 92|Participant assessment of satisfaction with treatment rated as very satisfied, quite satisfied, neither satisfied nor dissatisfied, quite dissatisfied, or very dissatisfied.|Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||Participants|||Count of Participants
2670670|NCT01483963|Secondary|Change From Baseline to Day 92 in ASES Function Subscale|Function subscale score ranging from 0-50, with 0 being most dysfunctional, derived from participant assessment of ability to do 10 activities with affected shoulder/arm where 0=unable to do to, 1=very difficult to do, 2=somewhat difficult, and 3=not difficult, and calculated as (cumulative total score for the 10 activity items) × (5/3); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||units on a scale||Standard Deviation|Mean
2670671|NCT01483963|Secondary|Change From Baseline to Day 92 in ASES Pain Subscale|"Pain subscale score ranging from 0-50, with 0 being greatest pain, derived from participant assessment of pain in response to How bad is the pain in your affected shoulder today? on an 11-point numerical rating scale (NRS) where 0=no pain at all and 10=pain as bad as it can be and calculated as (10 - NRS score) x 5); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation"|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||units on a scale||Standard Deviation|Mean
2670672|NCT01483963|Secondary|Change From Baseline to Day 92 in American Shoulder and Elbow Surgeons (ASES) Composite Score|Composite score ranging from 0-100, with 0 being worst pain and function loss, derived from the sum of the scores from pain subscale (11-point NRS where 0=no pain at all and 10=pain) and function subscale (activity questionnaire where 0=unable to do to, 1=very difficult to do, 2=somewhat difficult, and 3=not difficult); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||units on a scale||Standard Deviation|Mean
2670673|NCT01483963|Secondary|Change From Baseline to Day 92 in Passive Internal Rotation|PROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||degrees||Standard Deviation|Mean
2670674|NCT01483963|Secondary|Change From Baseline to Day 92 in Active Internal Rotation|AROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||degrees||Standard Deviation|Mean
2670675|NCT01483963|Secondary|Change From Baseline to Day 92 in Passive External Rotation|PROM measurement using a goniometer to assess external rotation in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||degrees||Standard Deviation|Mean
2670676|NCT01483963|Secondary|Change From Baseline to Day 92 in Active External Rotation|AROM measurement using a goniometer to assess external rotation in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||degrees||Standard Deviation|Mean
2670677|NCT01483963|Secondary|Change From Baseline to Day 92 in Passive Abduction|PROM measurement using a goniometer to assess abduction in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||degrees||Standard Deviation|Mean
2670678|NCT01483963|Secondary|Change From Baseline to Day 92 in Active Abduction|AROM measurement using a goniometer to assess abduction in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||degrees||Standard Deviation|Mean
2670679|NCT01483963|Secondary|Change From Baseline to Day 92 in Passive Forward Flexion|Passive range of motion (PROM) measurement using a goniometer to assess forward flexion in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||degrees||Standard Deviation|Mean
2670680|NCT01483963|Primary|Change From Baseline to Day 92 in Active Forward Flexion|Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder|Baseline, Day 92|All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)|||degrees||Standard Deviation|Mean
2670681|NCT01483937|Secondary|Head Shake Sensory Organization Test (HS_SOT)|"Head Shake Sensory Organization Test (HS-SOT)~HS-SOT instructs the patient to static stand shoulder width apart with eyes closed and uses the SOT Condition 5 sway surface protocol while shaking the head horizontally 120 degrees per second. This protocol is safe for patients when they have normalized all SOT scores. Because study subjects were reaching SOT normalization after Post Test 2, the data collected was scant and not suitable for analysis."|Pre Test, Post Test 1 and Post Test 4|||||||
2670682|NCT01483937|Secondary|Self-rated Disability Measured by Vestibular Rehabilitation Benefit Questionnaire Pre Test to Post Test 4|Vestibular Rehabilitation Benefit Questionnaire asks the patient to self-rate disability as it affects their quality of life. Scale goes from zero, no disability, to 100 or maximal disability. The Total Benefit includes two subsets: 1) dizziness symptoms, and 2) quality of life.|Pre test to Post Test 4 or 12 Physical Therapy sessions within 42 days||||units on a scale||Standard Deviation|Mean
2670683|NCT01483937|Secondary|Percent of Subjects Decreasing Fall Risk Measured by Berg Balance Scale Pre Test to Post Test 2|"Berg Balance Scale Description: 14-item scale designed to measure balance of the older adult in a clinical setting, and measures mobility related to activities of daily living. Description: This 14-item performance-based instrument is intended for individuals with some degree of balance impairment.~Scoring: A five-point ordinal scale, ranging from 0-4. 0 indicates the lowest level of function and 4 the highest level of function. Total Score = 56 with higher score indicting safer ambulation with lower risk of falling.~Criterion Validity: Authors support a cut off score of 45/56 for independent safe ambulation.~Interpretation: 41-56 = low fall risk 21-40 = medium fall risk 0 -20 = high fall risk~Riddle and Stratford, 1999, examined 45/56 cutoff validity and concluded:~Sensitivity = 64% (Correctly predicts fallers)~Specificity = 90% (Correctly predicts non-fallers)"|Pre Test, Post Test 2 after 4 physical therapy sessions within 10 days.||||percentage of participants|||Number
2670684|NCT01483937|Secondary|Percent of Subjects Reporting Decrease in Self-report Fall(s) Occurrence Pre Test to Post Test 1|A fall is an unintentional change in position causing an individual to land at a lower level, on an object, the floor, the ground or other surface with or without injury. This includes: slips, trips, falling into other people, being lowered, loss of balance, and legs giving way. (Exclude sudden onset of paralysis, epileptic seizure, or overwhelming external force.)|Pre Test to Post Test 1 after 2 physical therapy sessions within 4 days||||percentage of participants|||Number
2670685|NCT01483937|Secondary|Percent of Subjects Decreasing Fall Risk Measured by Functional Gait Assessment Pre Test to Post Test 2|"Functional Gait Assessment is a 10-item gait assessment based on the Dynamic Gait Index. Requirements: A marked 20 foot walkway that is marked with a 12 inch width. Scoring: a four-point ordinal scale, ranging from 0-3 where 0 indicates the lowest level of function and 3 the highest level of function. Total Score = 30 with higher score indicating safer ambulation with lower risk of falling.~Criterion Validity: Authors support a cut off score of 23/30 for independent safe ambulation.~Interpretation: 1) 0-19 is predictive of falls in the elderly. 2) 20-22 indicates likelihood of unexplained fall in community-dwelling, older adults, and predictive of likelihood of falling in patients with vestibular disorders.~3) 23-30 = safe ambulators"|Pre Test to Post Test 2 after four physical therapy sessions within 10 days||||percentage of participants|||Number
2670686|NCT01483937|Primary|Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change From Post Test 3 to Post Test 4 Sensory Organization Test (SOT).|Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.|Post Test 3 to Post Test 4 after twelve physical therapy sessions (6 weeks)||||units on a scale||Standard Deviation|Mean
2670687|NCT01483937|Primary|Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 2 to Post Test 3 Sensory Organization Test (SOT).|Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.|Post Test 2 to Post Test 3 after eight physical therapy sessions (4 weeks)||||units on a scale||Standard Deviation|Mean
2670688|NCT01483937|Primary|Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Post Test 1 to Post Test 2 Sensory Organization Test (SOT).|Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.|Post Test 1 to Post Test 2 after four physical therapy sessions (two weeks)||||units on a scale||Standard Deviation|Mean
2670689|NCT01483937|Primary|Assessment of the Efficacy of the SEMD Device in Improving Vestibular Function Was Evaluated With Change in Pre Test to Post Test 1 Sensory Organization Test (SOT).|Sensory Organization Test (SOT) is a standing balance test that measures the subject's ability to control postural sway under vestibular, visual, and somatosensory conflict. Score ranges from 0 to 100 with higher score indicating better control of postural sway.|Pre Test to Post Test 1 after two physical therapy sessions (one week)||||units on a scale||Standard Deviation|Mean
2670690|NCT01483924|Secondary|Efficacy of Apo805K1 as Assessed by Change From Baseline to Week 12 in Physician Global Assessment (PGA) Score|In the PGA, the physician assigns a single estimate of a patient's overall severity of the disease using a scale ranging from 0 (Clear) to 7 (Severe). (Unlike the LS-PGA, the individual elements of psoriasis plaque morphology or degree of body surface area involvement are not quantified.) Thus, a decrease in PGA score indicates improvement. This outcome measure compared the difference in change in PGA score from baseline to Week 12 between the active treatment groups and the placebo group.|Baseline to 12 weeks|The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
2670691|NCT01483924|Secondary|Efficacy of Apo805K1 as Assessed by Change From Baseline at Week 12 in Lattice System-Physician Global Assessment (LS-PGA) Scores|"The LS-PGA is a standardized method for determining categories of psoriasis severity. The percentage of body surface area involved is assessed on a scale ranging from 1 (0%) to 7 (51-100%); measures of plaque severity (thickness, erythema, and scaling) are assessed using a 4-point scale ranging from none to marked; and an algorithm is used to combine the above scores to determine a final score on a scale ranging from 0 (clear) to 7 (very severe). Thus, a decrease in LS-PGA score indicates improvement. This outcome measure compared the difference in change in LS-PGA score from baseline to Week 12 between the active treatment groups and the placebo group."|Baseline to 12 weeks|The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
2670693|NCT01483924|Secondary|Efficacy of Apo805K1 as Assessed by Change From Baseline in Psoriasis Area Severity Index (PASI) Scores|PASI is a quantitative measure of psoriasis that combines an assessment of the severity of lesions and a measurement of how much of the body surface area is affected into a single score ranging from 0 (no disease) to 72 (maximal disease). Thus, a decrease in PASI score indicates improvement. This outcome measure compared the difference in change in PASI score from baseline to Week 12 between the active treatment groups and the placebo group.|Baseline to 12 Weeks|The Efficacy Population was defined as all patients who received at least 1 dose of study medication and completed at least 1 post-baseline efficacy assessment.|||units on a scale||Standard Deviation|Mean
2670694|NCT01483924|Secondary|T 1/2 of Apo805K1 Following Multiple Doses, Assessed at Day 14|T 1/2 for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.|12 hours|The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14)|||hour||Standard Deviation|Mean
2670695|NCT01483924|Secondary|AUC 0-infinity of Apo805K1 Following Multiple Doses, Assessed at Day 14|AUC 0-infinity for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.|12 hours|The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14)|||ng *hr/mL||Standard Deviation|Mean
2670696|NCT01483924|Secondary|Tmax of Apo805K1 Following Multiple Doses, Assessed at Day 14|Tmax for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.|12 hours||||hour||Full Range|Median
2670697|NCT01483924|Secondary|Cmax of Apo805K1 Following Multiple Doses, Assessed at Day 14|"Cmax for dosages of 10 mg, 30 mg, 60 mg, or 100 mg Apo805K1, determined on Day 14. Serial blood samples for PK analysis were collected pre-dose and at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose.~."|12 hours|The Pharmacokinetics Population consisted of all patients who received Apo805K1 and provided evaluable PK data on at least one visit (Day 1 or Day 14)|||ng/mL||Standard Deviation|Mean
2670698|NCT01483924|Primary|Number of Patients With Adverse Events|The number of patients in each treatment group who reported at least 1 adverse event, including clinically significant changes from baseline in vital signs, 12-lead ECG, physical examinations and laboratory tests, from the time of the first dose until the last study visit.|12 Weeks|The Safety Population consisted of all patients who received at least 1 dose of study medication.|||participants|||Number
2670699|NCT01483872|Primary|Success Rate|Nine participants signed consent forms, only one randomized. Data was not analyzed.|90 days|Nine participants signed consent forms, only one randomized. Data was not analyzed.||||||
2670700|NCT01483820|Secondary|To Evaluate the Drug Levels and Pharmacokinetics (PK) of TPI 287 From Blood Samples at Multiple Time Points Within the First 24 Hours on Study.|To evaluate the pharmacokinetics (PK) of TPI 287 in the Phase I population of this trial.|1 year|PK's not run due to early closure of study. Data not collected or analyzed threfore no data exists.||||||
2670701|NCT01483820|Secondary|Quality of Life of Children Receiving TPI287 Using PedsQL Questionnaires|To evaluate the impact of QOL of children receiving TPI287 using PedsQL questionnaires|3 years|QOL's not collected due to early closure of study. Data not collected or analyzed threfore no data exists.||||||
2670702|NCT01483820|Secondary|Median Overall Survival (OS) of Participants|Overall Survival (OS) and clinical benefit (ORR + stable disease, SD)|3 years|Not evaluated due to early closure. Study data does not exist.||||||
2670703|NCT01483820|Secondary|Number of Days Participants Experienced Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|3 years||||Days|||Number
2670704|NCT01483820|Secondary|Number of Participants With Overall Response Assessed Using RECIST Criteria|Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 months||||participants|||Number
2670705|NCT01483820|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Phase I portion of trial- To determine the safety and tolerability of TPI 287 as a single agent in pediatric and young adult patients with refractory or recurrent neuroblastoma or medulloblastoma. Adverse events collected from time of first dose to 30 days past last dose and until all related events resolved, average of one year.|length of study +30 days||||participants|||Number
2670706|NCT01483807|Secondary|Speech Production of Untrained Items: Effect Sizes for Untrained Items|Change in accuracy of articulation of untrained items as measured by effect sizes reflecting magnitude of change. Production of words designated to not receive treatment (i.e., generalization items) was measured repeatedly in non treatment probes prior to treatment, throughout all study phases, and at 10 weeks post treatment with percent accuracy calculated for each probe (0% to 100% correct). Change in accuracy of articulation of untrained items was measured from baseline to 10 weeks post treatment using effect size calculations as the indicator of magnitude of change. Effect size calculations involved calculating the difference between post- and pre-treatment probe accuracy percentages with corrections made for variability (standard deviations in performance). The larger the effect size, the greater the change in performance from pre-treatment.|Baseline vs. 10 weeks post all treatment|20 speakers with chronic apraxia of speech and aphasia|||effect size||Full Range|Mean
2670742|NCT01483352|Primary|Percentage of Participants With Signs of Infection in the Tissue Around the Port|Signs of infection were determined by the physician and categorized as follows : Category 1= None; 2= Minor, negligible; 3= Some, noticeable 4= Major; 5= Severe. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||percentage of participants|||Number
2670911|NCT01480843|Primary|Change in Duration of Hypoglycemia Episodes|duration of hypoglycemia measured by continuous glucose monitoring|baseline, 5 months, 8 months|Subject drop outs|||minutes of hypoglycemia||Standard Deviation|Mean
2670707|NCT01483807|Secondary|Speech Production: Percent Change in Untrained Items|Percent change in articulatory accuracy of untrained items measured by change in percent accuracy over highest baseline value; production of words designated to NOT receive treatment (untrained items) was measured repeatedly in non treatment probes prior to treatment, throughout all study phases, and at 10 weeks post treatment with percent accuracy calculated for each probe (maximum = 100%, minimum = 0% correct). Effect size calculations involved calculating the difference between post- and pre-treatment probe accuracy percentages with corrections made for variability (standard deviations in performance). The larger the effect size, the greater the change in performance from pre-treatment. Positive effect sizes = increases in accuracy & negative effect sizes = decreases in accuracy.|baseline to 10 weeks post treatment|20 participants with chronic apraxia of speech and aphasia|||% change||Full Range|Mean
2670708|NCT01483807|Primary|Speech Production: Percent Change in Treated Items|Change in accuracy of articulation of treated items as measured by percent increase in accuracy above the highest baseline measurement; production of words designated for treatment was measured repeatedly in non treatment probes prior to treatment, throughout all study phases, and at 10 weeks post treatment with percent accuracy calculated for each probe (0% to 100% correct). The highest percentage accuracy achieved in pre-treatment probes was subtracted from the percentage accuracy achieved at 10 weeks post-treatment to obtain change in accuracy value - this reflects change from maximum correct performance in baseline (pre-treatment). e.g., if in baseline probes, performance ranged from 10% to 30% accuracy and at post treatment performance was 90% accuracy, the change value would be 60% (90% minus 30%). A greater change value indicates greater change in articulation/production of words. Change could be positive (improved articulation) or negative (poorer articulation).|baseline to 10 weeks post treatment|20 speakers with chronic apraxia of speech and aphasia received both arms of treatment.|||% change||Full Range|Mean
2670709|NCT01483807|Primary|Speech Production: Effect Size for Treated Items|Change in accuracy of articulation of trained items as measured from baseline to 10 weeks post treatment using effect size calculations as the indicator of magnitude of change; production of words designated for treatment was measured repeatedly in non treatment probes prior to treatment, throughout all study phases, and at 10 weeks post treatment with percent accuracy calculated for each probe (maximum = 100%, minimum = 0% correct). Effect size calculations involved calculating the difference between post- and pre-treatment probe accuracy percentages with corrections made for variability (standard deviations in performance). The larger the effect size, the greater the change in performance from pre-treatment. Positive effect sizes = increases in accuracy & negative effect sizes = decreases in accuracy.|Pre treatment (2-3 week period preceding the start of treatment) vs. 10 weeks post all treatment|20 speakers with chronic apraxia of speech and aphasia; effect sizes were calculated for each speaker for each treatment condition.|||effect size||Full Range|Mean
2670710|NCT01483651|Primary|Area Under the Curve for Glucose Above Baseline|The change in the rate of glucose appearance will be assessed by measuring the stable glucose isotope (dideuterated glucose, D2) using a gas chromatography-mass spectrometry assay. The units of the area under the curve are defined as milligrams per kilogram of glucose, since the dependent variable is a rate of glucose production [mg/kg/min] measured over time [min]. The time variable therefore cancels out. Additionally, this area under the curve is being normalized per microgram of glucagon delivered.|60 minutes after each glucagon administration||||mg/kg glucose per mcg glucagon||Standard Deviation|Mean
2670711|NCT01483625|Secondary|Weekly Rescue Medication Use Over the 12 Weeks of Study|Daily rescue albuterol use was recorded in the diary in response to the following question: How many puffs of rescue medication did you use during the last 24 hours? The weekly rescue medication use was derived by summing the daily uses over the 12 weeks and dividing this total by 12 weeks.|12 weeks|TS with non missing rescue medication use.|||puffs||Standard Deviation|Mean
2670712|NCT01483625|Secondary|Responder Status at Week 12 Clinic Visit|"Responder status was determined at each clinic visit. The number and percentage of subjects in each of the following 3 classes were presented:~Subject recovered without change of therapy (subjects who received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1 were not included).~Subject recovered but had a change in therapy (subject received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1).~Subject did not recover."|12 weeks|TS with non missing responder data at week 12. Responder defined by >= 20% improvement. .|||participants|||Number
2670713|NCT01483625|Secondary|Responder Status at Week 4 Clinic Visit|"Responder status was determined at each clinic visit. The number and percentage of subjects in each of the following 3 classes were presented:~Subject recovered without change of therapy (subjects who received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1 were not included).~Subject recovered but had a change in therapy (subject received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1).~Subject did not recover."|4 weeks|Responder defined by >= 20% improvement. TS with non missing responder data.|||participants|||Number
2670714|NCT01483625|Secondary|Trough FVC (in Litres) at 12 Weeks|The trough Forced Vital Capacity (FVC) was defined as the FVC measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of study drug.|12 weeks|TS with non missing FVC data.|||Litres||Standard Deviation|Least Squares Mean
2670715|NCT01483625|Secondary|Time to Recovery From Acute Respiratory Symptoms|"Time to recovery was assessed with the EXACT-PRO questionnaire tool. The EXACT-PRO was designed to collect data to quantify frequency, severity, and duration of exacerbations in patients with COPD including the onset of and the recovery from COPD exacerbations.~The EXACT-PRO is a 14-item questionnaire. Each attribute or item was assessed on a five- or six-point ordinal scale and summed to yield a total score that was converted to a 0-100 scale, with higher scores indicating a more severe health state or exacerbation.~The EXACT-PRO was answered by the patients on a daily basis in the evening."|12 weeks|TS with non missing EXACT-PRO data.|||units on a scale||Standard Deviation|Geometric Mean
2670716|NCT01483625|Primary|Trough FEV1 After 12 Weeks on Study Drug|The primary endpoint was trough forced expiratory volume in 1 second (FEV1) after 12 weeks on study drug. Trough forced expiratory volume in 1 second (FEV1)was defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of study drug.|12 weeks|Treated Set (TS) with non missing FEV1 data.|||Litre||Standard Error|Least Squares Mean
2670717|NCT01483599|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16|The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants.|Baseline and Week 16|Population analyzed included all participants who were randomized. Here, 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2670718|NCT01483599|Secondary|Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 40|PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema [0 (no evidence of plaque) to 5 (dusky to deep red coloration)], induration [0 (no plaque evaluation) to 5 (marked plaque evaluation)] and scaling [0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).|Week 40|Population analyzed included all participants who were randomized. Here, 'Number of participants analyzed' signifies those participants who were evaluable for this outcome measure. The placebo reporting group was not planned to be analyzed in this outcome measure.|||percentage of participants|||Number
2670719|NCT01483599|Secondary|Difference in Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) in CNTO1959 Groups Compared With Adalimumab Group at Week 16|PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema [0 (no evidence of plaque) to 5 (dusky to deep red coloration)], induration [0 (no plaque evaluation) to 5 (marked plaque evaluation)] and scaling [0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).|Week 16|Population analyzed included all participants who were randomized.|||percentage of participants|||Number
2670720|NCT01483599|Secondary|Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16|The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percentage (%)-100% involvement), and for erythema, induration and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. PASI 75 response was defined as at least a 75% reduction in PASI relative to Baseline.|Week 16|Population analyzed included all participants who were randomized.|||percentage of participants|||Number
2670721|NCT01483599|Primary|Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16|PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point. Lesions were graded as erythema [0 (no evidence of plaque) to 5 (dusky to deep red coloration)], induration [0 (no plaque evaluation) to 5 (marked plaque evaluation)] and scaling [0 (no evidence of scaling) to 5 (severe; very thick tenacious scaling)]. The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0= cleared; 1= minimal; 2= mild; 3= moderate; 4= marked and 5= severe).|Week 16|Population analyzed included all participants who were randomized.|||percentage of participants|||Number
2670722|NCT01483560|Secondary|Change in Endothelial Function|In some centres (Arbitrary units) Reactive Hyperaemia Index using the ENDOPAT device (Itamar, Israel)|Baseline, Year 1, Year 3||||RHI (Arbitrary units)||Standard Deviation|Mean
2670723|NCT01483560|Secondary|Change in Insulin Dose|Units/ kg body weight Extracted by study nurses from the Study Diary and reported on the study CRF using dedicated fields|Baseline, Year 1, Year 2, Year 3||||units/kg||Standard Deviation|Mean
2670724|NCT01483560|Secondary|Change in Weight|Measured at sites using calibrated weighing scales|Baseline, Year 1, Year 2, Year 3||||kg||Standard Deviation|Mean
2670725|NCT01483560|Secondary|Number of Participants With Retinopathy and at Least a 2 Stage Progression in Retinopathy From Baseline to 36 Months|Two color 45° field retinal photographs (fields 1 and 2) from each eye at 0 and 36 months graded at the University of Wisconsin Ocular Epidemiology Reading Center (OERC) using the modified Airlie House classification scheme and the Early Treatment Diabetic Retinopathy Severity scale.|Baseline, Year 3||||Participants|||Count of Participants
2670726|NCT01483560|Secondary|Change in Estimated Glomerular Filtration Rate|Number of participants developing new microalbuminuria; change in absolute concentration Calculated using the MDRD equation1 based on creatinine measured in accredited local laboratories|Baseline, Year 1, Year 2, Year 3||||ml/min/1.73m2||Standard Deviation|Mean
2670727|NCT01483560|Secondary|Change in LDL Cholesterol|mmol/L Centrally assayed at the University of Glasgow|Baseline, Year 3||||mmol/L||Standard Deviation|Mean
2670728|NCT01483560|Secondary|Change in HbA1c|Measured in accredited local laboratories participating in DCCT-aligned quality control programmes.|Baseline, Year 3||||%units||Standard Deviation|Mean
2670729|NCT01483560|Primary|Change in Averaged Mean Far Wall Common Carotid Artery Intima-media Thickness (cIMT)|Progression of averaged mean far wall common carotid artery intima media thickness IMT (mean cIMT) measured using B mode ultrasonography with a 7.0 MHz or higher broadband linear array transducer and concurrent recording of 3-lead electrocardiogram (ECG). Longitudinal images of the common carotid artery will be obtained at anterior, lateral and posterior angles at baseline, 12, 24 and 36 months using Meijer's arc to standardize the transducer angle.|0, 12 months, 24 months, 36 months||||mm||Standard Deviation|Mean
2670760|NCT01483183|Primary|Part 2/1 Infusion: Cmax|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
2670731|NCT01483352|Secondary|Design Validation Participant Questionnaire - Percentage of Participants With a Positive Response|The participant questionnaire consisted of two parts including description of routine operations, followed by 23 questions used to determine the following: percentage of participants needing consultation of instructions for use of fixation disc or infusion set; percentage of participants with pain after implantation, percentage of participants with moderate pain during 4 to 6 days after implantation, moderate pain for 7 days or more; percentage of participants with temporal disconnection from infusion set; percentage of participants with use of handling aid for temporal storage; percentage of participants with a reason for temporal disconnection of infusion set from port either sex, shower, or sport; percentage of participants changing fixation disc ≥3 days or infusion set ≥4 days and the cartridge, and percentage of participants cleaning the skin around the port daily, every second day, or every third to fifth day, either with saline during healing or with alcohol after healing.|Week 12|All participants were included in the analysis.|||percentage of participants|||Number
2670732|NCT01483352|Secondary|Percentage of Participants Achieving Target Glucose Levels|"Target glucose values were 70-180 mg/dL. Participants with glucose levels below 70 mg/dL were considered to be under target and those above 180 mg/dL were considered over target. The mean of Glucose-Measurements at the visit date was calculated as follows: a variable was created for each category (within target [70-180 mg], below target and above target) that tells if the value lies within this category. Then the percentage per participant and visit was calculated. The mean represents the mean of these percentages per participant at the visit."|Screening, Week 12 and 6 Months|All participants were included in the study; n= number of participants analyzed for the given parameter at the specified timepoint|||percentage of participants||Standard Deviation|Mean
2670733|NCT01483352|Secondary|Glycemic Variability: Percent Coefficient of Variation in Blood Glucose|Both self monitored (SMBG) and continuous (CGM) glucose measurements were used to determine the coefficient of variation in blood glucose. CGM data are only evaluated for a 1 week time period and are no direct comparison to the SMBG that reflect the full time frame between visits.|Screening, Week 12 and Months 6, 9 and 12|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||percent of mean glucose value||Standard Deviation|Mean
2670734|NCT01483352|Secondary|Continuous Glucose Measurement (CGM) - Glucose Levels|CGM measurements were performed using a diurnal CGM sensor and group means were calculated over 10 minute periods of the CGM measurements.|Screening, Week 12 and 6 Months|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||mg/dL||Standard Deviation|Mean
2670735|NCT01483352|Secondary|Self Monitored Blood Glucose Levels|Participants monitored glucose levels on a daily basis and recorded for evaluation. Glucose levels are measured as milligrams per deciliter (mg/dL)|Screening, Week 12 and Months 6, 9 and 12|All participants were included in analysis; n= number of participants analyzed for the given parameter at the specified time point|||mg/dL||Standard Deviation|Mean
2670736|NCT01483352|Secondary|Hemoglobin A1c Levels|Glycated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. HbA1c levels are a measure of glycemic control.|Screening, Week 12 and Months 6, 9 and 12|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||percent of glycated hemoglobin||Standard Deviation|Mean
2670737|NCT01483352|Secondary|Insulin Doses Dispensed From Insulin Pump|Total insulin dose (in international units per milliliter [IU/mL]) from pump was measured per day as mean per day measured over 7 days.|Screening, Week 12 and Months 6, 9 and 12|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||IU/mL||Standard Deviation|Mean
2670738|NCT01483352|Primary|Percentage of Participants Categorized by Ability of the Port to Deliver Insulin Intraperitonally|Problems in ability to deliver insulin intraperitoneally was determined by the physician and categorized as follows: 1= No problems; 2= Minor problems; 3= Some problems; 4= Major problems and/or replacement of catheter necessary; 5= Severe problems and/or explanation of port necessary. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||percentage of participants|||Number
2670739|NCT01483352|Primary|Percentage of Participants With Signs of Infection/Allergic Reaction at the Site of Implant|Signs of infection/allergic reaction at the site of implant was determined by the physician and categorized as follows: 1= No problems; 2= Minor problems; 3= Some problems; 4= Major problems and/or replacement of catheter necessary; 5= Severe problems and/or explanation of port necessary. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||percentage of participants|||Number
2670740|NCT01483352|Primary|Percentage of Participants With Persistent Dull Pain Due to Catheter|Pain due to catheter was determined by a participant questionnaire and categorized as follows: Category 1= No pain; 2= Minor, negligible; 3= Some, noticeable; 4= Major, cumbersome; 5= Severe, almost unbearable. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||percentage of participants|||Number
2670741|NCT01483352|Primary|Percentage of Participants With Signs of Pain in the Tissue Around the Port|Signs of pain was determined from the participant questionnaire which was categorized as follows: category 1= No pain; 2= Minor, negligible; 3= Some, noticeable; 4= Major, cumbersome; 5=Severe, almost unbearable. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||percentage of participants|||Number
2670912|NCT01480674|Secondary|The Duration of Treatment of Trastuzumab|Total treatment duration and duration of the first line of treatment is reported.|Up to 1 Year|Analyzed Set population included all enrolled participants without any protocol deviation used as a primary analysis population for all efficacy outcome measures.|||Years||Standard Deviation|Mean
2670743|NCT01483352|Primary|Percentage of Participants With Signs of Redness/Swelling in the Tissue Around the Port|Signs of Redness/Swelling was determined by the physician and was categorized as follows: Category 1= None; 2= Minor, negligible; 3= Some, noticeable; 4= Major; 5= Severe. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||percentage of participants|||Number
2670744|NCT01483352|Primary|Percentage of Participants With Dislocation of Port|Position of the port was determined by the physician and was categorized as follows: Category 1= No dislocation; 2= Minimal dislocation; 3= Clearly visible dislocation, with minimal impairment of function; 4= Dislocation impairs functions; 5= Dislocation results in disabling functions. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the analysis; n= number of participants analyzed for the given parameter at the specified timepoint|||percentage of participants|||Number
2670745|NCT01483352|Primary|Percentage of Participants With Problems Involving the Tight Connection Between Port and Skin|Mechanical stability of the device was determined by the stability of the ingrowth surrounding the port as determined by the physician. The ingrowth problems are categorized as follows: Category 1= complete stable Ingrowth, 2= Ingrowth working with negligible problems, 3= Ingrowth working with some problems, 4= Ingrowth working with major problems and 5= Ingrowth resulting in almost non-functional port. The percentage of participants in each category for the specified time point is presented.|Weeks 2 and 12 and Months 6, 9, 12 and 15|All participants were included in the study; number (n)= number of participants analyzed for the given parameter at the specified timepoint|||percentage of partcipants|||Number
2670746|NCT01483352|Primary|Suitability of the Device - Overall Suitability Score|Suitability of the device was assessed by the investigator using a questionnaire that determined the following: 1) condition of the tissue around the port: tight connection between port and skin (mechanical stability, dislocation of port, signs of redness/swelling, infection, or pain), 2) peritoneal reactions (persistent dull pain due to catheter, signs of infection/allergic reaction) and ability to deliver insulin intraperitonally at every visit after implantation. Suitability score was determined using participant's responses to a questionnaire where 1 equals (=) no problem, 2=minor/negligible problems, 3=some/noticeable problems, 4=major/cumbersome and 5=severe/almost unbearable problems. Each question was scored and an average across the questions was determined as an overall score. The scores ranged from 1 (not at all suitable) to 5 (completely suitable).|Week 12|All participants who received the implant were included in the analysis.|||units on a scale||Standard Deviation|Mean
2670747|NCT01483209|Secondary|Digital Amputations|The number of digits amputated in our patient cohort is a secondary endpoint of this study. We will use a paired t-test to compare the number of digital amputations in the control versus experimental group.|12 months|Due to insufficient accrual, data analysis was not performed.||||||
2670748|NCT01483209|Primary|Perfusion (as Determined by Laser Doppler Measurements)|A paired T-test will be used to compare pre- and post-injection Laser Doppler measurements for the experimental hand. We will again use a paired t-test to compare the experimental hand against the contralateral control hand. Results for the experimental and control groups will be plotted and displayed graphically as percent change in Doppler flow (y-axis) and time (x-axis).|12 months|Due to insufficient accrual, data analysis was not performed.||||||
2670749|NCT01483183|Secondary|Part 2: Duration of NSR|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|168 hours|||||||
2670750|NCT01483183|Secondary|Part 2: Duration of NSR|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
2670751|NCT01483183|Secondary|Part 2: Time to NSR|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
2670752|NCT01483183|Secondary|Part 1: Percentage of Participants With NSR|Percent of participants with NSR, defined as NSR for at least 1 minute within 30 minutes of the end of OPC-108459 infusion.|30 minutes|Safety dataset included all participants who had received at least one dose of the trial medication.|||percentage of participants|||Number
2670753|NCT01483183|Primary|Part 2: Percentage of Subjects With Normal Sinus Rhythm (NSR)|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
2670754|NCT01483183|Primary|Part 2: Diastolic and Systolic Blood Pressure|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
2670755|NCT01483183|Primary|Part 2: Ventricular Rate|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
2670756|NCT01483183|Primary|Part 2: QTcF|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
2670757|NCT01483183|Primary|Part 2/2 Infusions: AUCt|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
2670758|NCT01483183|Primary|Part 2/1 Infusion: AUCt|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
2670759|NCT01483183|Primary|Part 2/2 Infusions: Cmax|The trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.|24 hours|||||||
2670761|NCT01483183|Primary|Part 1: Maximal Change From Baseline in Blood Pressure Within 24 Hour Infusion|Maximum change from baseline in diastolic and systolic blood pressure(BP) collected during vital sign measurements in the 24-hour postdose interval. Participants must be hemodynamically stable defined as a screening systolic blood pressure between 90 to 160 mmHg, diastolic <100 mmHg. BP was measured after at least 3 minutes in the supine position. BP was measured at predose (within 45 minutes of dosing); 3 and 7 minutes and approximately 1, 4, 8, 12, and 24 hours.|24 hours|Safety dataset included all participants who had received at least one dose of the trial medication.|||mmHg||Standard Deviation|Mean
2670762|NCT01483183|Primary|Part 1: Maximal Change From Baseline in Ventricular Rate Within 24 Hour Infusion|12-lead Holter monitors were placed on all participants within 45 minutes prior to dosing. Post dose measurements were made at 2, 4, 6, 8, 10, 20, 30, and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hours post-dose. To achieve consistent recording, Holter sampling will be recorded with the participant recumbent and at rest for at least 10 minutes prior to collection.|24 hours|Safety dataset included all participants who had received at least one dose of the trial medication.|||beats/minute||Standard Deviation|Mean
2670763|NCT01483183|Primary|Part 1:Maximal Change From Baseline in QT Interval Corrected for Heart Rate Using the Fridericia Formula (QTcF) Within 24 Hour Infusion|12-lead Holter monitors were placed on all participants within 45 minutes prior to dosing. Post dose measurements were made at 2, 4, 6, 8, 10, 20, 30, and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hours post-dose. To achieve consistent recording, Holter sampling will be recorded with the participant recumbent and at rest for at least 10 minutes prior to collection.|24 hours|Safety dataset included all participants who had received at least one dose of the trial medication.|||msec||Standard Deviation|Mean
2670764|NCT01483183|Primary|Part 1: Area Under the Concentration-time Curve From Time 0 to Time of the Last Measurable Concentration (AUCτ)|OPC-108459 was administered as a 10-minute constant rate IV infusion. Blood samples were collected pre-dose (within 45 minutes of dosing), at the end of infusion and 0.5, 1, 2, 4, 8 and 24 hours post infusion.|24 hours|PK analysis dataset included all participants who had concentration time profiles consistent with proper intravenous infusion.|||μg∙h/mL||Standard Deviation|Mean
2670765|NCT01483183|Primary|Part 1: Maximum (Peak) Plasma Concentration (Cmax)|OPC-108459 was administered as a 10-minute constant rate IV infusion. Blood samples were collected pre-dose (within 45 minutes of dosing), at the end of infusion and 0.5, 1, 2, 4, 8 and 24 hours post start of infusion.|24 hours|PK analysis dataset included all participants who had concentration time profiles consistent with proper intravenous infusion.|||μg/mL||Standard Deviation|Mean
2670766|NCT01483118|Secondary|Change in Glucose Response|Change in Glucose Response - area under the curve (AUC), trapezoidal method - in overweight patients with PCOS between baseline and after 6 months of daily cinnamon compared to the corresponding change in patient receiving 6 months of placebo. Fasting blood samples were drawn followed by a 2 hour glucose tolerance test with blood draws at 30, 60, and 120min post glucose ingestion.|Baseline and 6 Months - fasting bloods, followed by glucose tolerance test with draws at 30, 60, and 120 minutes post glucose ingestion||||mg/dL*min||Inter-Quartile Range|Median
2670767|NCT01483118|Secondary|Change in Insulin Resistance|The changes in insulin resistance parameters in overweight patients with PCOS between baseline and after 6 months of daily cinnamon compared to the corresponding change in patients receiving 6 months of placebo. Higher values of insulin resistance represent a worse outcome. A higher value Homeostasis Model of Insulin Resistance indicates more insulin resistance so higher values are worse outcomes (a score of >2 is considered healthy for adults with scores >5 being considered severe insulin resistance). For the Quant. Insulin Sensitivity Check Index, a lower value indicates more insulin resistance so lower values are worse outcomes (values can range from .45, which is considered normal in health individuals and .30, which is characteristic of diabetes).|Baseline and 6 months||||Insulin sensitivity indices||Inter-Quartile Range|Median
2670768|NCT01483118|Primary|Number of Menses During the Six Month Study Period.|Ovulatory cycles will be confirmed by serum progesterone levels.|Up to 6 months||||Number of menstrual cycles per month||Inter-Quartile Range|Median
2670769|NCT01482962|Secondary|Change Form Baseline in Reported Symptoms and Quality of Life (QoL) Assessment Per Functional Assessment of Cancer Therapy-Lymphoma (FACT-LYM) for Functioning and Symptoms|The FACT-LYM includes the Functional Assessment of Cancer Therapy General Scale (FACT-G) and a 15-item lymphoma-specific subscale (LYM) over the past week. The FACT-G has 27 items that incorporate 4 scales including physical well-being (PWB; 7 items), social/family well-being (SWB, 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). The combined FACT-LYM instrument consists of a total of a 42 item questionnaire. Each question is answered on a 5- point scale of 0 (not at all) to 4 (very much) for a total possible score of 168. Higher scores indicate better well-being and a positive change from Baseline indicates improvement.|Baseline and End of Treatment (EOT) (Up to 152 Weeks)|ITT population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing.|||score on a scale||Standard Deviation|Mean
2670770|NCT01482962|Secondary|Plasma Concentration-time Data to Contribute to Future Population Pharmacokinetics (PK) Analysis||Cycle 1, Days 1 and 7; Cycle 2, Day 8; Cycle 3, Day 8; Cycle 4, Day 8. Duration is approximately 4 months.|This Outcome Measure was registered in error and is not a Primary or Secondary Outcome Measure.||||||
2670771|NCT01482962|Secondary|Time to Subsequent Antineoplastic Therapy|Time to subsequent antineoplastic therapy was defined as the time from randomization to the first date of subsequent antineoplastic therapy (excluding transplant). Participants without subsequent antineoplastic therapy were censored at the date of death or last known to be alive.|From date of last study drug to date of subsequent antineoplastic therapy, if required; approximately 3 years|ITT population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing.|||days||95% Confidence Interval|Median
2670798|NCT01482767|Secondary|Number of Participants With Grade 2 or Higher Signs and Symptoms and Laboratory Abnormalities and Other Serious AEs|This outcome measure was intended for a potential interim analysis when study data up to Week 28 were complete. However, this interim analysis was not conducted. Refer to Outcome Measure 2 above for the safety outcome that includes the whole study duration from entry to week 72.|From study treatment dispensation to Week 28|This outcome measure was intended for a potential interim analysis which was not conducted.||||||
2670772|NCT01482962|Secondary|Time to Response|Time to Response is defined as the time from the date of randomization to the date of first documentation of PR or better.|At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years|All responders in response-evaluable population defined as participants with peripheral T-cell lymphoma confirmed by independent hematopathology central review with measurable disease at baseline who receive at least 1 dose of alisertib or comparator drug and 1 postbaseline response assessment of CR, PR, SD or PD by independent radiology committee.|||days||95% Confidence Interval|Median
2670773|NCT01482962|Secondary|Duration of Response (DOR)|DOR was defined as the time from the date of first documentation of a PR or better to the date of first documentation of progressive disease (PD)/relapse for responders as assessed by the IRC using IWG criteria. Responders without documentation of PD/relapse were censored at the date of last response assessment that was stable disease (SD) or better.|At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years|All responders in response-evaluable population defined as participants with peripheral T-cell lymphoma confirmed by independent hematopathology central review with measurable disease at baseline who receive at least 1 dose of alisertib or comparator drug and 1 postbaseline response assessment of CR, PR, SD or PD by independent radiology committee.|||days||95% Confidence Interval|Median
2670774|NCT01482962|Secondary|Time to Disease Progression (TTP)|Time to Progression (TTP) was defined as the time from the date of randomization to the date of first documentation of PD/relapse.|At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years|ITT population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing.|||days||95% Confidence Interval|Median
2670775|NCT01482962|Secondary|Complete Response (CR) Rate|Complete Response (CR) rate is defined as the percentage of participants with CR as assessed by the IRC using IWG criteria (2007 Cheson). CR= Disappearance of all evidence of disease.|At the end of every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until PD (approximately 3 years)|Response-evaluable population was defined as participants with peripheral T-cell lymphoma confirmed by an independent hematopathology central review, with measurable disease at baseline, who receive at least 1 dose of alisertib or the comparator drug, and 1 postbaseline response assessment of CR, PR, SD or PD by the independent radiology committee.|||percentage of participants||95% Confidence Interval|Number
2670776|NCT01482962|Secondary|Number of Participants With Clinically Important Vital Sign Measurements Reported as AEs|Vital signs included blood pressure, heart rate and temperature. Individual clinically significant changes in vital signs were reported by the investigator as TEAEs.|First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)|Safety population was defined as all participants who received at least 1 dose of alisertib, or one of the comparator drugs. Participants were analyzed according to the treatment actually received.|||participants|||Number
2670777|NCT01482962|Secondary|Number of Participants With Clinically Important Abnormal Laboratory Values Reported as AEs|Clinical laboratory tests included chemistry, hematology and urinalysis test. Clinically significant treatment-emergent laboratory abnormalities were reported by the investigator as TEAEs.|First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)|Safety population was defined as all participants who received at least 1 dose of alisertib, or one of the comparator drugs. Participants were analyzed according to the treatment actually received.|||participants|||Number
2670778|NCT01482962|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/ birth defect or is a medically important event.|First dose to 30 days after last dose of study drug or comparator (Up to 152 Weeks)|Safety population was defined as all participants who received at least 1 dose of alisertib, or one of the comparator drugs. Participants were analyzed according to the treatment actually received.|||participants|||Number
2670779|NCT01482962|Secondary|Overall Survival (OS)|OS was defined as the time from the date of randomization to the date of death. Participants without documentation of death were censored at the date last known to be alive.|Participants were followed for survival for 2 years from date of last participant off study treatment, or death, whichever occurs first. Contacts were every 4 months (Median follow-up 519 days in the alisertib arm and 586 days in the comparative arm)|ITT population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing.|||days||95% Confidence Interval|Median
2670780|NCT01482962|Primary|Progression-Free Survival (PFS) Based on IRC Assessment|PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurred first.|Every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years|Intent-to-treat (ITT) population was defined as all participants who were randomized. The participants were analyzed according to the treatment they were randomized to receive, regardless of any errors of dosing.|||days||95% Confidence Interval|Median
2670799|NCT01482767|Secondary|Number of Participants With Undetectable HCV RNA at Week 16, 20, 24 and 28 Study Visits|Undetectable HCV RNA was defined as below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0. This outcome measure was intended for a potential interim analysis when study data up to Week 28 were complete. However, this interim analysis was not conducted.|Weeks (W) 16, 20, 24, and 28|This outcome measure was intended for a potential interim analysis which was not conducted.||||||
2670781|NCT01482962|Primary|Overall Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment|ORR was defined as the percentage of participants who achieve Complete Response (CR) or Partial Response (PR) as assessed by the IRC using International Working Group (IWG) criteria. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites.|Every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years|Response-evaluable population, participants with peripheral T-cell lymphoma confirmed by an independent hematopathology central review, with measurable disease at Baseline, who received at least 1 dose of alisertib or comparator and had postbaseline response assessment of CR, PR, stable disease (SD) or progressive disease (PD) by the IRC.|||percentage of participants||95% Confidence Interval|Number
2670782|NCT01482910|Secondary|Percentage of Participants Who Lost Fewer Than 15 Letters at Week 28 - LOCF|Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.|At week 28|Full analysis set|||Percentage of participants|||Number
2670783|NCT01482910|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 28 - Last Observation Carried Forward (LOCF)|Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.|Baseline and at week 28|Full analysis set|||Letters correctly read||Standard Deviation|Mean
2670784|NCT01482884|Secondary|Immunogenicity|Incidence of anti-drug antibodies (ADA) to tralokinumab in serum.|Pre-dose sampling at baseline, Week 8, 12, 16, and 24.|The safety analysis set consist of all randomised participants who received at least one dose of study medication.|||participants|||Number
2670785|NCT01482884|Secondary|Serum Concentration of Tralokinumab||Pre-dose sampling at baseline, Week 4, 8, 12, 16, 20, and 24.|The safety analysis set consist of all randomised participants who received at least one dose of study medication.|||ug/ml||Full Range|Mean
2670786|NCT01482884|Secondary|Change From Baseline in Calprotectin||From baseline to Week 4, 8, 12, 16, 20, and 24.|The full analysis set consist of all randomised participants|||ug/g||Full Range|Mean
2670787|NCT01482884|Secondary|Change From Baseline in Albumin||From baseline to Week 4, 8, 12, 16, 20, and 24.|The full analysis set consist of all randomised participants|||g/L||Full Range|Mean
2670788|NCT01482884|Secondary|Change From Baseline in C - Reactive Protein||From baseline to Week 4, 8, 12, 16, 20, and 24.|The full analysis set consist of all randomised participants|||mg/L||Full Range|Mean
2670789|NCT01482884|Secondary|Change From Baseline in Modified Riley Score|Modified Riley score is biopsy grade which range from 0-5; where 0: Normal mucosa, 1: Infiltration of lymphocytes and plasma cells in the lamina propria, 2: Infiltration of neutrophils and eosinophils in the lamina propria, 3: Infiltration of neutrophils in the epithelium, 4: Crypt destruction, 5: Erosion and/or ulceration.|Eight week treatment period|The full analysis set consist of all randomised participants however the numbers for the endpoints mentioned for this secondary outcome are lower due to missing data.|||Grade on scale||Standard Error|Least Squares Mean
2670790|NCT01482884|Secondary|Change From Baseline in Partial Mayo Score|The partial Mayo score is the sum of the three sub-score areas: stool frequency, rectal bleeding, and the physician's global assessment.The partial Mayo score ranges from 0-9, with higher scores indicating a more severe disease. Change from baseline: Mayo score at each post-baseline timepoint (week 4, 8, 12, 16, 20, and 24) minus the Mayo score at baseline.|From baseline to Week 4, 8, 12, 16, 20, and 24.|The full analysis set consist of all randomised participants|||Score on scale||Full Range|Mean
2670791|NCT01482884|Secondary|Clinical Remission at Week 8 Based on Mayo Score|Participants were classified as in remission if Mayo score of ≤2 with no individual sub score exceeding 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician's global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.|Eight week treatment period|The full analysis set consist of all randomised participants|||Percentage of participants|||Number
2670792|NCT01482884|Secondary|Mucosal Healing at Week 8 Based on Mayo Score|Improvement of the endoscopy sub score (from the Mayo score) from 3 or 2 to 0 or 1 point, or from 1 to 0 points.|Eight week treatment period|The full analysis set consist of all randomised participants|||Percentage of participants|||Number
2670793|NCT01482884|Secondary|Change in Mayo Score From Baseline to Week 8|Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician's global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease. Change from baseline: Mayo score at week 8 minus the Mayo score at baseline.|Eight week treatment period|The full analysis set consist of all randomised participants however the numbers for the endpoints mentioned for this secondary outcome are lower due to missing data.|||Score on scale||Standard Error|Least Squares Mean
2670794|NCT01482884|Primary|Clinical Response at Week 8 Based on Mayo Score|Clinical response was measured as a decrease in Mayo score of ≥3 points from baseline, decrease in the total Mayo score from baseline ≥30 percentage and a decrease in the sub score for rectal bleeding ≥1 or absolute sub score for rectal bleeding of 0 or 1 point. Mayo score is sum of four sub-scores: stool frequency, rectal bleeding, endoscopy findings and the physician's global assessment. The total Mayo score ranges from 0-12, with higher scores indicating a more severe disease.|Eight week treatment period|The full analysis set consist of all randomised participants|||Percentage of responders|||Number
2670795|NCT01482819|Primary|Endothelia Blebs|0 to 100% of area; measured as a percentage of corneal area with blebs.|after 20 minutes of lens wear|Subjects who were enrolled, randomized and completed the study.|||percentage of area|eyes|Standard Deviation|Mean
2670796|NCT01482819|Primary|Limbal Redness|grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade.|after 8 hours of lens wear|Subjects who were enrolled, randomized, and completed the study.|||units on a scale|eyes|Standard Deviation|Mean
2670797|NCT01482819|Primary|Corneal Swelling|measured in microns using the Optical Low Coherence Reflectometry (OLCR) Pachymeter. This pachymeter gives corneal thickness measurements to the accuracy of 1 micron (µm)|after 8 hours of lens wear|Subjects who were enrolled, randomized, and completed the study. One eye from each subject was measured.|||microns|eyes|Standard Deviation|Mean
2670800|NCT01482767|Secondary|Number of Participants With Undetectable HCV RNA at Week 4, 8 and 12 Study Visits|Undetectable HCV RNA was defined as below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0.|Weeks (W) 4, 8, 12|All eligible participants with HCV RNA result available at the respective visit (numbers of participants in Category Titles below; n). Participants who discontinued treatment early due to HCV virologic failure, safety or any other reason started following a separate visit schedule and are not included here.|||participants|||Number
2670801|NCT01482767|Secondary|CD4+ T-Cell Count (CD4) Change From Baseline|Change in CD4 T-cell count was calculated as value at the post entry visit minus the value at entry.|Entry and weeks (W) 8, 12, 24, 28, 40, 48, 52, 60, 72|All eligible participants enrolled with CD4 result available from entry and the respective post-entry visit (numbers of participants in Category Titles below; n). Participants who discontinued treatment early due to HCV virologic failure, safety or any other reason started following a separate visit schedule and are not included here.|||cells/mm^3||Inter-Quartile Range|Median
2670802|NCT01482767|Secondary|Percentage of Participants With HIV-1 Viral Load <50 Copies/mL|HIV-1 RNA testing was performed with Abbott RealTime HIV-1 assay (LLOQ=40 copies/mL) or with Roche COBAS AmpliPrep/Taqman HIV-1 assay (LLOQ=20 copies/mL).|Entry and weeks (W) 4, 8, 12, 24, 28, 40, 48, 52, 60, 72|All eligible participants with HIV-1 RNA result available at the respective visit (numbers of participants in Category Titles below; n). Participants who discontinued treatment early due to HCV virologic failure, safety or any other reason started following a separate visit schedule and are not included here.|||percentage of participants|||Number
2670803|NCT01482767|Secondary|Percentage of Participants With Sustained Virologic Response at 12 Weeks After Treatment Discontinuation (SVR12)|SVR12 was defined as undetectable HCV RNA (below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0) at 12 weeks after treatment discontinuation. Participants without HCV RNA for SVR12 determination were considered not to have achieved SVR12.|12 weeks after treatment discontinuation|All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).|||percentage of participants||95% Confidence Interval|Number
2670804|NCT01482767|Secondary|Percentage of Participants With Grade 3 or Higher Adverse Events (AEs)|Number of participants who experienced an AE (sign or symptom or laboratory abnormality) of Grade 3 or higher at any time after baseline while on study. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening.|From study treatment dispensation to Week 72|All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).|||percentage of participants||95% Confidence Interval|Number
2670805|NCT01482767|Primary|Percentage of Participants With Sustained Virologic Response at 24 Weeks After Treatment Discontinuation (SVR24)|SVR24 was defined as undetectable HCV RNA (below the lower limit of quantitation of the assay and target not detected by Roche COBAS® TaqMan® HCV Test v2.0) at 24 weeks after treatment discontinuation. Participants without HCV RNA for SVR24 determination were considered not to have achieved SVR24.|24 weeks after treatment discontinuation|All eligible participants enrolled (Group B participants who were found ineligible after enrollment, n=5, were excluded).|||percentage of participants||95% Confidence Interval|Number
2670806|NCT01482429|Primary|Length of Intensive Care Unit Stay||days|||||||
2670807|NCT01482429|Primary|Duration of Mechanical Ventilation||days|||||||
2670808|NCT01482429|Primary|Duration of Weaning From Mechanical Ventilation||days|overall|||days||Standard Deviation|Mean
2670809|NCT01482429|Primary|Mortality||length of ICU stay (days)|Overall|||participants|||Number
2670810|NCT01482351|Secondary|Clinical Dementia Rating Scale (CDR)|Cognitive ability will be assessed and staged using CDR. It contains 6 items (memory, orientation, judgement and problem solving, community affairs, home and hobbies, personal care), and each item ranges from 0 to 3. The total score ranges from 0 to 18, a higher score indicates a worse outcome. We observed the change of CDR score from baseline to 1-year follow up. Improved on CDR was defined as a lower CDR score compared to baseline. Reference group is unimproved, defined as worsened (higher) CDR or unchanged CDR compared to baseline.|Change from baseline at 1 year|Study participants who completed the study and improved on CDR data adjusted for age, race and marital status.|||participants|||Number
2670811|NCT01482351|Secondary|Alzheimer's Disease Cooperative Study - Clinicians' Global Impression of Change Scale (ADCS-CGIC)|Global change (progression) will be assessed using ADCS-CGIC at 1 year. It has 8 categories as markedly improved, moderately improved, minimally improved, not changed, minimally worse, moderately worse, markedly worse, missing response.|Change from baseline at 1 year|Participants who completed the study and improved on ADCS-CGIC scores at 1year adjusted for age, race and marital status.|||participants|||Number
2670812|NCT01482351|Secondary|Everyday Function Outcome: Everyday Cognition (E-Cog)|This informant-rated composes of multiple subscales, to evaluate cognitively based functional abilities in older adults. The factor structure of Everyday Cognition was assessed with confirmatory factor analysis, which supported a 7-factor model including 1 global factor and 6 domain-specific factors (Everyday Memory, Language, Visuospatial Abilities, Planning, Organization, and Divided Attention). The total mean score ranges from 0 to 57. A higher score indicates a worse outcome.|Change from baseline at 6 months and 1 year|14 participants were lost to follow up prior to 6 months testing.|||score on a scale||Standard Deviation|Mean
2670813|NCT01482351|Secondary|Functional Outcomes Sleep Questionnaire (FOSQ)|Everyday function will be assessed using FOSQ. It is a 30-item Likert-scale, self-report, disease-specific functional status measure written at the 4th grade level. The total score ranges from 0 to 120, a higher score indicates a better outcome.|Change from baseline at 6 months and 1 year|14 participants were lost to follow-up prior to 6-months testing.|||score on a scale||Standard Deviation|Mean
2670814|NCT01482351|Primary|Epworth Sleepiness Scale [ESS]|Daytime sleepiness be assessed using ESS. The ESS asks the respondent to rate the likelihood of falling asleep in eight specific situations using a four-point Likert scale ranging from never dozing to high chance of dozing. The scale significantly correlates with the frequency of apneas and is a clinical and research standard for the assessment of daytime sleepiness. The total score ranges from 0 to 24, a higher score indicates higher chance of daytime sleepiness (worse outcome).|Change from baseline at 6 months and 1 year|14 participants were lost to follow-up prior to 6-months testing.|||score on a scale||Standard Deviation|Mean
2670815|NCT01482351|Primary|The Psychomotor Vigilance Task (PVT)|Attention/reaction time will assessed using the PVT. The participants sat in a closed and quiet examination room, without any auditory or visual disturbance. A 1-minute mock PVT demonstration was done prior to each test. The PVT visual display was held 14-22 inches from the subject's eyes. The participants were asked to either use the index finger or thumb of their dominant hand to respond to the PVT signals. The participants were instructed to maintain the fastest possible reaction times to a simple visual stimulus: a red light emitting diode displaying time in milliseconds in a window of the portable PVT device. We used number of lapses, defined as mean reaction time above 500 milliseconds (errors of omission) as the primary outcome. Lower score indicates better outcomes (Less lapses).|Change from baseline at 6 months and 1 year|14 participants were lost to follow-up prior to 6-months testing.|||score on a scale||Standard Deviation|Mean
2670816|NCT01482351|Primary|Stroop Color and Word Test (SCW)|"Attention will be measured using SCW. We used the Golden and Freshwater's (2002) version. This version provides paper stimuli for each trial: in the first, columns of the wordsredblue and green are printed in black ink (Word Reading; W); in the second, columns of the same words are printed in red, blue, or green ink (Color Naming; C); in the third, the words red blue and green are printed in a colored ink (red, blue or green) that does not match the word (Color-Word; CW). Participants read each page aloud as quickly as possible for 45 seconds and receive a score for each trial representing the number of items correctly read aloud. The Interference T-score is obtained by first calculating a deviation score by subtracting a predicted CW score from the obtained raw CW score (in 45s). The obtained deviation score is then converted to an Interference T-score. Lower T scores(T<40) in the Interference condition show reductions in inhibitory control."|Change from baseline at 6 months and 1 year|14 participants were lost to follow-up prior to 6-months testing.|||score on a scale||Standard Deviation|Mean
2670817|NCT01482351|Primary|Mini Mental State Evaluation Exam (MMSE)|Global cognitive function will be assessed using MMSE. It is a 30-item cognitive screen measuring orientation, registration, short-term memory, attention/concentration, language, and constructional capacity. Summary score will be used as a measure of global cognitive function. Total score ranges from 0 to 30, equal to and above 24 is normal (better outcome), less than 21 indicates increasing odds of dementia (worse outcome).|Change from baseline at 6 months and 1 year|14 participants lost to follow-up prior to 6-months testing.|||score on a scale||Standard Deviation|Mean
2670818|NCT01482351|Primary|Digit Symbol Subtest (DS)|The Digit Symbol subtest (DS) from the Wechsler Adult Intelligence Scale (WAIS-R) was used to measure psychomotor/cognitive processing speed. An age-adjusted total scaled score was used for analysis. The adjusted total score ranges from -5.7 to+27. A higher score indicates a better outcome.|Change from baseline at 6 months and 1 year|14 participants lost to follow-up prior to 6-months testing.|||score on a scale||Standard Deviation|Mean
2670819|NCT01482351|Primary|Hopkins Verbal Learning Test-Revised (HVLT-R)|Memory (immediate and delayed recall) will be assessed using HVLT-R. HVLT-R has been used in elders with Alzheimer's Disease and takes 10 minutes to complete. Total score ranges from 0 to 60, a higher score indicates a better memory (better outcome).|Change from baseline at 6 months and 1 year|14 participants lost to follow-up prior to 6-months testing.|||score on a scale||Standard Deviation|Mean
2670820|NCT01482325|Primary|Data Collection for Engineering Development|"This was a data collection for engineering development to demonstrate SuperSTAT 2.0 NIBP software algorithm meets the engineering specifications. Engineers reviewed data produced by each blood pressure determination to work on new software algorithm in development. This was not conducted as program was terminated prematurely.~Software iterations are not pre-defined."|After each iteration of software development|Subject analysis was not performed because study was prematurely terminated. Work on the project ceased when it was terminated.The study was intended to have the engineers review data produced by each blood pressure determination to work on new software algorithm in development. This was not and will not be conducted.||||||
2670821|NCT01482312|Primary|Ocular Comfort|Ocular comfort was assessed by the participant after 90 minutes in the LHE and quantified as a linear measure (cm) on a modified Visual Analog Scale (VAS) of 0-20 cm, with a higher number indicating greater perceived comfort.|90 minutes|As treated.|||cm|Participants|Standard Deviation|Median
2670822|NCT01482312|Primary|Tear Osmolarity|The participant spent 90 minutes in the LHE (low humidity environment) chamber, after which tears were sampled from the lower tear meniscus (thin strip of tear fluid at the lower lid margin) and tear osmolarity was measured using a TearLab osmometer, a device that measures the osmolarity of human tears to aid in the diagnosis of dry eye disease. Tear osmolarity is the measure of solid particles (salt) in a solution (tears), and a higher number can be indicative of dry eye disease, while a lower number is generally indicative of the normal tear osmolarity.|90 minutes|As treated.|||mOsms/L|Participants|Standard Deviation|Mean
2670823|NCT01482221|Secondary|Change From Baseline in Self-rated Severity of Depressive Symptoms as Measured by Quick Inventory of Depressive Symptomatology Self-Rated 16-item Scale (QIDS-SR-16) Total Score|A 16-question self-report inventory that includes the 9 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria symptom domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance (4 items: initial, middle, late insomnia, and hypersomnia), appetite/weight increased or decrease (4 items), and psychomotor agitation/retardation (2 items). The QIDS-SR-16 total scores range from 0 (least severe) to 27 (most severe).|Baseline to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||units on a scale||Standard Error|Least Squares Mean
2670824|NCT01482221|Secondary|"Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of Very Much Improved or Much Improved) at Week 12"|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Baseline to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||percentage of participants analyzed|||Number
2670837|NCT01482091|Secondary|Hypoxia|Number of participants who had hypoxia within 30 min of study drug adminsitration|Every 5 minutes until 30 minutes after study drug administration||||participants|||Number
2670825|NCT01482221|Secondary|"Change in Severity of Depressive Symptoms as Measured by the CGI-I Response (Defined as CGI-I Rating of Very Much Improved or Much Improved) at Week 6"|A 3-part, clinician-administered scale that rates the improvement or worsening of the patient's illness from randomization (baseline). Each item is scored on a 1 to 7 scale. CGI-I scores >4 indicate worsening, while scores <4 indicate improvement.|Baseline to Week 6|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||percentage of participants analyzed|||Number
2670826|NCT01482221|Secondary|Change in Severity of Depressive Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score|Clinical Global Impression - Severity (CGI-S) scale rates the severity of the patient's illness at the time of assessment, range from 1 (normal, not ill) to 7 (very severely ill).|Baseline to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||units on a scale||Standard Error|Least Squares Mean
2670827|NCT01482221|Secondary|Change From Baseline in Functional Impairment as Measured by the Change From Baseline in the Sheehan Disability Scale (SDS) Total Score|A 3-item, self-administered scale that measures the extent a patient is impaired by their disease. Higher scores indicate more severe impairment. The SDS total score is calculated as the sum of the score for the 3 intercorrelated domains (school/work, social life, and family life/home responsibilities), ranges from 0 (no impairment) to 30 (most severe impairment).|Baseline to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||units on a scale||Standard Error|Least Squares Mean
2670828|NCT01482221|Secondary|Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 12|The percentage of patients who were Remitted (defined as MADRS total score ≤10) was calculated.|Baseline to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||percentage of participants analyzed|||Number
2670829|NCT01482221|Secondary|Percentage of Patients Who Were Remitted (Defined as MADRS Total Score ≤10) at Week 6|The percentage of patients who were Remitted (defined as MADRS total score ≤10) was calculated.|Baseline to Week 6|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||percentage of participants analyzed|||Number
2670830|NCT01482221|Secondary|Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 12|The percentage of patients who were Responders (defined as ≥50% reduction from baseline in MADRS total score) was calculated.|Baseline to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||percentage of participants analyzed|||Number
2670831|NCT01482221|Secondary|Percentage of Patients Who Were Responders (Defined as a ≥50% Reduction From Baseline in MADRS Total Score) at Week 6|The percentage of patients who were Responders (defined as ≥50% reduction from baseline in MADRS total score) was calculated.|Baseline to Week 6|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||percentage of participants analyzed|||Number
2670832|NCT01482221|Secondary|Percentage of Patients With Sustained Response From Week 6 to Week 12 (Defined as ≥50% Reduction From Baseline in the MADRS Total Score at Week 6 and Which is Maintained Through Week 12)|The percentage of patients with with Sustained Response (defined as ≥50% reduction from baseline in the MADRS total score at Week 6 and which is maintained through Week 12) was calculated.|Week 6 to Week 12|The mITT analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||percentage of participants analyzed|||Number
2670833|NCT01482221|Secondary|Change From Baseline to Week 12 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Baseline to Week 12|The modified intent-to-treat (mITT) analysis set included all randomized patients, who took IP and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||units on a scale||Standard Error|Least Squares Mean
2670834|NCT01482221|Primary|Change From Baseline to Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|A 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. The MADRS total score is calculated as the sum of the 10 individual item scores; the total score can range from 0 to 60. Higher MADRS scores indicate higher levels of depressive symptoms.|Baseline to Week 6|The modified intent-to-treat (mITT) analysis set included all randomized patients, who took investigational product (IP) and who have a non-missing baseline MADRS total score and at least 1 post-baseline MADRS total score, classified according to their randomized treatment.|||units on a scale||Standard Error|Least Squares Mean
2670835|NCT01482169|Secondary|Duration to Baseline Hyperemia After Aminophylline Injection|In the regadenoson arm, the duration to baseline hyperemia after aminophylline Injection|seconds|Of the 48 patients enrolled, 7 of the patients did not have measurements for the secondary outcome.|||seconds||Standard Deviation|Mean
2670836|NCT01482169|Primary|Comparing Measurement of Fractional Flow Reserve (FFR)|For the first measurement of FFR, the subject will receive Adenoscan® by IV infusion. Then the FFR measurements will be taken. When vital signs have returned to normal, after two minutes the line will be flushed with saline. The subject will then receive Regadenoson by IV infusion and repeat FFR measurements will be recorded. The subject will be administered aminophylline and the time duration it takes to return to baseline hemodynamic will be recorded.|DAY 1||||FFR||Standard Deviation|Mean
2670841|NCT01482091|Secondary|Change in Pain Score at 30 Minutes|"Change in pain score between 0 and 30 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score, which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.~To calculate the change, the reported pain score at 30 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 30 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 30 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 30 minutes) representing a INCREASE in pain between the two time points."|Baseline and 30 minutes after administration of study drug||||units on a scale||Inter-Quartile Range|Median
2670842|NCT01482091|Secondary|Change in Pain Score at 10 Minutes|"Change in pain score between 0 and 10 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score , which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.~To calculate the change, the reported pain score at 10 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 10 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 10 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 10 minutes) representing a INCREASE in pain between the two time points."|Baseline and 10 minutes after administration of study drug||||units on a scale||Inter-Quartile Range|Median
2670843|NCT01482091|Secondary|Time to Study Drug Administration||Time from triage to adminstration of study drug||||minutes||Standard Deviation|Mean
2670844|NCT01482091|Secondary|Total Amount of Narcotics Administered|Given multiple confounding and extraneous factors, reliable data was not able to be obtained for this outcome measure|Participants will be followed for the duration of their ED visit, an expected average of 6 hours|||||||
2670845|NCT01482091|Secondary|Length of Stay in ED|Given multiple confounding factors, reliable data was not able to be obtained for this outcome measure|Time from triage until either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours|||||||
2670846|NCT01482091|Secondary|Admission Rate||This will be assessed at either discharge from the ED or admission to an inpatient unit, an expected average of 6 hours after triage||||participants|||Number
2670847|NCT01482091|Secondary|Presence of Headache||Participants will be followed for the duration of their ED visit, an expected average of 6 hours||||participants|||Number
2670848|NCT01482091|Secondary|Presence of Bradycardia|Number of participants who had bradycardia|Every 5 minutes until 30 minutes after study drug administration||||participants|||Number
2670849|NCT01482091|Primary|Change in Pain Score 20 Minutes After Administration of Study Drug|"Change in pain score between 0 and 20 minutes using the Wong Baker FACES pain scale (WBFPS). The WBFPRS has six faces, with each face representing an increasing severity of pain the more rightward it is on the scale (0 is the lowest score , which represents the least amount of pain, while 10 is the highest score which represents the greatest level of pain).. Each face has an even number underneath it, consecutively.~To calculate the change, the reported pain score at 20 minutes was subtracted from the reported baseline pain score. Thus, the higher change in pain score is indicative of a GREATER change in pain (i.e. greater decrease in pain at 20 minutes compared to baseline). The greatest possible changes in pain would be a 10 (pain score of 10 at baseline and 0 at 20 minutes) representing a DECREASE in pain between the two time points, and -10 (pain score of 0 at baseline and 10 at 20 minutes) representing a INCREASE in pain between the two time points."|Baseline and 20 minutes after administration of study drug||||units on a scale||Inter-Quartile Range|Median
2670850|NCT01482065|Secondary|MRI Indices||6 Months|We were not able to obtain MRI data from 2 people within the CPAP group at 6 months. One withdrew from study and the other a clear scan could not be obtained.|||percentage of fat in liver||Standard Deviation|Mean
2670851|NCT01482065|Secondary|Analysis of Variance (ANOVA) in CPAP Versus No-CPAP Therapy on NAFLD|we will test our hypothesis that CPAP therapy improves NAFLD. The main independent variables will be CPAP vs. deferred-CPAP therapy. In a subanalysis, responses in the CPAP treatment group will be compared based on compliance. Compliance with CPAP is defined as using it on > 70% of the days, at least 4 h per night. Our primary outcome will be serum activity of ALT and AST. We will use ANOVA to examine changes in ALT and AST depending on CPAP therapy group and compliance. Secondary outcomes will include the degree of hepatic steatosis and fibrosis, as assessed by MRI.|6 months|We were unable to achieve enrollment goals due to limited clinical indications. Thereby not obtaining enough participant data to do an Analysis of Variance (ANOVA).||||||
2670852|NCT01482065|Secondary|Liver Values|Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) activity.|6 Months|Withdrawal by subject in CPAP group.|||U/L||Standard Deviation|Mean
2670853|NCT01482065|Primary|Cross Sectional Analysis of NAFLD Versus Sleep Apnea Severity Indices (AHI)|Cross-sectional analysis will be performed in NAFLD study participants from the Johns Hopkins (JH) Hepatology Clinic to examine the relationship between findings on liver biopsy and sleep apnea severity indices. The main predictor variable will be presence/severity of OSA and nocturnal oxyhemoglobin desaturation (assessed by T90%, time w/ oxyhemoglobin desaturation < 90%; Delta SaO2 between baseline and minimal oxyhemoglobin saturation, and standard deviation of nocturnal SaO2). Our primary outcome will be NAFLD activity score on biopsy.|6 months|We were unable to obtain liver biopsy on most of our participants due to limited clinical indications.||||||
2670873|NCT01481779|Secondary|Fasting Serum Glucose (FSG) by Laboratory Measurement|LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.|26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FSG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2670854|NCT01481935|Primary|Contamination of Disposable Isolation Gown and Gloves With Methicillin-resistant Staphylococcus Aureus or Multi-drug-resistant Acinetobacter Baumannii|Swabs will be collected from the disposable gown and gloves of healthcare workers exiting the enrolled room. A single swab will be used for both gloves and the gown. The swab will be assayed for methicillin-resistant Staphylococcus aureus, multi-drug-resistant Acinetobacter baumannii, or both, depending on which organism(s) the occupant of the enrolled room is colonized with. The swab will be considered positive if the relevant organism is isolated. We will sample the first 15 healthcare worker exits after the room has received the allocated intervention.|As a healthcare worker exits the enrolled room (1 day)|Unit of analysis was the ICU room. Results from multiple participants who occupied a single room over the course of the trial were summarized by room.|||percentage of positive cultures|Rooms|Standard Error|Mean
2670855|NCT01481896|Secondary|Patient Satisfaction Per Hip|Whether or not an individual is satisfied with the outcome of their hip arthroplasty is evaluated using a questionnaire. Since a participant with both hips replaced could have a different level of satisfaction for each hip, patient satisfaction is reported per hip.|At a mean of 5.6 years after primary total hip arthroplasty||||number of participants|Participants||Number
2670856|NCT01481896|Secondary|Component Revision Per Hip|For implants that require a component revision, the reason for the revision is determined based on the pre-operative history and operative findings at the time of revision. Since a participant with both hips replaced could have a revision of each hip, component revision is reported per hip.|At a mean of 6.7 years after primary total hip arthroplasty||||number of hips|Participants||Number
2670857|NCT01481896|Secondary|Implant Stability Per Hip|Implant stability is classified and stable/bone ingrown, fibrous fixed or loose and evaluated using conventional radiographs. Since a participant with both hips replaced could have a different type of stability for each hip, implant stability is reported per hip.|At a mean of 5.6 years after primary total hip arthroplasty|All hips that had a follow-up x-ray taken at least 4.75 years after their joint replacement were included.|||number of hips|Participants||Number
2670858|NCT01481896|Secondary|Osteolysis Per Hip|Osteolysis is defined as localized areas of peri-prosthetic bone loss that did not exist prior to surgery and is evaluated using radiographs and CT scans. Since a participant with both hips replaced could have a osteolysis present or absent for each hip, osteolysis is reported per hip.|At a mean of 5.6 years after primary total hip arthroplasty|Patients who had radiographs or computed tomography (CT) scans taken as part of routine care were included.|||Number of hips with osteolysis|Participants||Number
2670859|NCT01481896|Secondary|Harris Hip Score Per Hip|Harris Hip Scores are derived from a patient questionnaire and physical examination. Since a participant with both hips replaced could have different Harris Hip Scores for each hip, the Harris Hip Scores are reported per hip.|At a mean of 5.6 years after primary total hip arthroplasty||||units on a scale|Participants|Full Range|Median
2670860|NCT01481896|Secondary|Cup Orientation Per Hip|Cup orientation including abduction and anteversion is determined using follow-up radiographs. Since a participant with both hips replaced could have different cup orientations for each hip, cup abduction and anteversion angles are reported per hip.|On the first post-operative anteroposterior pelvic radiograph after primary total hip arthroplasty|Cup orientation was measured for all 131 total hip replacements included in the study population.|||degrees|Participants|Full Range|Median
2670861|NCT01481896|Primary|Metal Ion Levels Per Participant|Metal ion levels include cobalt and chromium ion levels determined from tests of blood samples. Metal ion levels are reported per participant since blood samples were taken from individual participants who could have had one or both hips replaced.|At a mean of 4.2 years after primary total hip arthroplasty|Patients who had blood drawn and analyzed for serum cobalt levels as part of routine care are included.|||micrograms per liter||Full Range|Median
2670862|NCT01481779|Secondary|Rapid Assessment of Physical Activity (RAPA)|The RAPA questionnaire assesses the level and intensity of physical activity of adult participants. It contains 2 subscales: RAPA 1 (Aerobic) and RAPA 2 (Strength and Flexibility). RAPA 1 contains 7 questions regarding the participant's amount and intensity of physical activity, allowing each participant's aerobic activity level to be categorized as sedentary, underactive, light activities, light activity, regular underactive, or active. RAPA 2 contains 2 questions regarding participants' physical activities that increase strength and improve flexibility. Each participant's strength and flexibility activity level is then categorized as neither strength nor flexibility (flex) activity, either strength or flex (not both), both strength and flex activity. The percentage of participants in each RAPA 1/2 category is presented and was calculated by dividing the number of participants in each RAPA 1/2 category by the total number of participants analyzed, then multiplying by 100.|26 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable RAPA data. Missing endpoints were imputed with the LOCF method, using only post-baseline data.|||percentage of participants|||Number
2670863|NCT01481779|Secondary|European Quality of Life-5 Dimension (EQ-5D)|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) using a 3-level scale of 1-3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using ANCOVA, adjusting for treatment and stratification factors (baseline HbA1c [≤8.5% or >8.5%] and country) as fixed effects and baseline EQ-5D score as a covariate.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable EQ-5D data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2670874|NCT01481779|Secondary|Percentage of Participants With Nocturnal Hypoglycemic Events|Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia and/or a BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with nocturnal hypoglycemic episodes by the total number of participants analyzed, then multiplying by 100.|Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||percentage of participants|||Number
2670864|NCT01481779|Secondary|Low Blood Sugar Survey (LBSS)|LBSS (also referenced as Hypoglycemia Fear Survey - II [HFS-II]) is a 33-item questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%] and country), visit, treatment-by-visit interaction , and corresponding baseline dependent variable as the fixed effects and participants as the random effect.|26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable LBSS data at both baseline and post-baseline.|||units on a scale||Standard Error|Least Squares Mean
2670865|NCT01481779|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ)|ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS means were calculated using an analysis of covariance (ANCOVA) model with treatment and stratification (baseline HbA1c [≤8.5% or >8.5%] and country) as fixed effects and baseline value of the dependent variable as a covariate.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable ITSQ data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2670866|NCT01481779|Secondary|Percentage of Participants With Change in Anti-LY2605541 Antibodies|The percentage of participants with a treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable or from detectable to the value with at least 130% relative increase from baseline.|Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable anti-LY2605541 antibody data at baseline and post-baseline. Missing endpoints were imputed with the LOCF method.|||percentage of participants|||Number
2670867|NCT01481779|Secondary|Lipid Profile|Concentrations of cholesterol, high-density lipoprotein cholesterol (HDL-C), LDL-C, and triglycerides are summarized. LS means were calculated using MMRM, adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL] except for the LDL-C outcome variable), visit, treatment, treatment-by-visit interaction, and baseline value of corresponding lipid outcome variable.|26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable lipid data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2670868|NCT01481779|Secondary|Basal, Bolus, and Total Insulin Dose|Basal insulin dose, short-acting bolus insulin dose (each meal and overall), and total insulin dose were calculated based on the dose during the last 7 days prior to the post-treatment visit or last 3 days prior to the randomization visit. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.|26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable insulin dose data.|||units/kg/day||Standard Error|Least Squares Mean
2670869|NCT01481779|Secondary|Change From Baseline in Body Weight|LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.|Baseline and 26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable body weight data at both baseline and post-baseline.|||kilograms (kg)||Standard Error|Least Squares Mean
2670870|NCT01481779|Secondary|9 Point Self-monitored Blood Glucose (SMBG)|9-point SMBG profiles were obtained over 2 days within the week prior to Weeks 0, 4, 12, 26, 39, 52, 65, and 78. SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the pre-morning meal the next day. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.|26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2670871|NCT01481779|Secondary|0300-hour Blood Glucose (BG) to Fasting Blood (FBG) Glucose Excursion|Results of a 0300-hour to pre-morning meal (FBG) excursion are presented (only SMBG profiles with both 0300 hours and the next day pre-morning measurements are included for the calculation of such excursion). LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects and participants as the random effect.|26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2670872|NCT01481779|Secondary|Fasting Blood Glucose (FBG) Intra-participant Variability|FBG was measured by self-monitored blood glucose (SMBG). Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], baseline LDL-C level [<100 mg/dL and ≥100 mg/dL], and country), visit, treatment-by-visit interaction, and corresponding baseline dependent variable as the fixed effects, and participants as the random effect.|26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FBG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2670875|NCT01481779|Secondary|Nocturnal Hypoglycemia Rates (Adjusted by 30 Days)|Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or a documented BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline nocturnal hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.|Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||episodes/participant/30 days||Standard Error|Mean
2670876|NCT01481779|Secondary|Percentage of Participants With Total Hypoglycemia Events|Hypoglycemic events are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, then multiplying by 100.|Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||percentage of participants|||Number
2670877|NCT01481779|Secondary|Total Hypoglycemia Rates (Adjusted by 30 Days)|Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). Group mean rates of total hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline total hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.|Baseline through 26 weeks and Baseline through 52 weeks and Baseline through 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||episodes/participant/30 days||Standard Error|Mean
2670878|NCT01481779|Secondary|Proportion of Participants With Hemoglobin A1c (HbA1c) Less Than 7.0% Without Nocturnal Hypoglycemia|Hypoglycemic episodes are defined as an event that is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 millimoles per liter [mmol/L]). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with HbA1c <7.0% without nocturnal hypoglycemia by the total number of participants analyzed, then multiplying by 100.|26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data. Missing endpoints were imputed with the LOCF method.|||percentage of participants|||Number
2670879|NCT01481779|Secondary|Percentage of Participants With Hemoglobin A1c (HbA1c) Less Than 7.0% or Less Than or Equal to 6.5% Using Last Observation Carried Forward (LOCF)|HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe. The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, then multiplying by 100.|26 weeks and 52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with the LOCF method, using only post-baseline data.|||percentage of participants|||Number
2670880|NCT01481779|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c)|HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline LDL-C [<100 mg/dL and ≥100 mg/dL] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.|Baseline, 26 weeks, 52 weeks, 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
2670881|NCT01481779|Secondary|Hemoglobin A1c (HbA1c)|HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe. LS means were calculated using MMRM, adjusting for treatment, stratification factors (baseline LDL-C [<100 mg/dL and ≥100 mg/dL] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects.|52 weeks and 78 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
2670882|NCT01481779|Primary|Hemoglobin A1c (HbA1c) at 26 Weeks|HbA1c is a test that measures a participant's average blood glucose level over a 2- to 3-month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM), adjusting for treatment, stratification factors (baseline low-density lipoprotein cholesterol [LDL-C] [<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL] and country), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
2670883|NCT01481740|Secondary|Neonatal Acidosis||intraoperative||||pH value||Standard Deviation|Mean
2670884|NCT01481740|Secondary|Incidence of Hypotension||intraoperative - postdelivery||||participants|||Number
2670885|NCT01481740|Secondary|Incidence of Hypotension||intraoperative - predelivery||||participants|||Number
2670886|NCT01481740|Primary|Incidence of Nausea and Vomiting||24hrs postoperative||||participants|||Number
2670887|NCT01481740|Primary|Incidence of Nausea and Vomiting||2 hrs postoperative||||participants|||Number
2670888|NCT01481740|Primary|Incidence of Nausea and Vomiting||intraoperative 2-3 hours||||participants|||Number
2670909|NCT01481116|Primary|Change From Baseline in HbA1c at Weeks 78 and 104|The change in the value of HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) to be collected at Weeks 78 and 104 relative to baseline.|Baseline and Weeks 78 and 104|Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline assessment.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2670889|NCT01481558|Primary|Apathy Symptoms|Apathy evaluated by Apathy Scale by Starsktein et al, 1992, which consists of 14 items phrased as questions that are to be answered by the caregiver on a four-point Likert scale. The total score range from 0 to 42, with higher scores indicating greater apathy severity. Apathy was assessed at baseline and at the end of the sixth session (second week).|Differences in outcome measure comparing second week to baseline|"alpha=5%, power=80%, SD estimated at 8 on Apathy scale scores, and correlation coefficient estimated at 0.7, a sample with 20 participants per arm is required to detect a between-group effect size of 0.5.~Intention to treat (ITT) analyses were conducted using the method of last observation carried forward (LOCF) for missing data."|||units on a scale||95% Confidence Interval|Mean
2670890|NCT01481376|Secondary|Hospital Length of Stay||Duration of the hospital stay (expected average of 1 day)||||Days||Standard Deviation|Mean
2670891|NCT01481376|Secondary|Operative Time||From skin incision to closure (The expected median operating time is 36 minutes for unilateral and 50 minutes for bilateral repair)|||||||
2670892|NCT01481376|Secondary|Patient Satisfaction||at least 12 month post-operatively||||participants|||Number
2670893|NCT01481376|Secondary|Postoperative Complications Including, Infection, Seroma, Hematoma, Visceral Adherence, Allergy Etc||up to 12 months||||participants|||Number
2670894|NCT01481376|Secondary|Analgesic Use||The day of the discharge (an expected average of 1 day), 1month and at least 12 month post-operatively|||||||
2670895|NCT01481376|Secondary|Incidence of Groin Pain (Pain Score 0-10)||12 month post-operatively||||participants|||Number
2670896|NCT01481376|Primary|Proportion of Subjects Who Experience Hernia Recurrence (Defect Treated Initially With Parietex™ ProGrip™) Within 12 Months Post-surgery.|Recurrence is defined as a clinically manifest bulge or a protrusion exacerbated by a Valsalva maneuver in the operated groin. The recurrence symptoms are assessed by phone based on the Symptoms Questionnaire and the recurrence diagnosis is confirmed during a physical examination by a physician.|At least 12 months post-surgery||||participants|||Number
2670897|NCT01481324|Primary|Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours)|Number of hours per day in brace will be measured by pressure sensor at the end of month 1, month 2 and month 3. Parent report of brace wear will also be documented at each of these timepoints. Wear rate percentage will be calculated by dividing the number of hours of brace wear (either actual as measured by the sensor or reported by parent diary) by the recommended 24 hours.|3 months||||percentage of time worn||Full Range|Mean
2670898|NCT01481129|Secondary|Toxicity as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0||Up to 30 days||||Participants|||Count of Participants
2670899|NCT01481129|Secondary|Progression-free Survival (PFS)|Analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method.|From the date of inclusion to the date of first documented disease progression, relapse or death from any cause, assessed up to 4 years||||months||95% Confidence Interval|Median
2670900|NCT01481129|Secondary|Overall Survival|Analyzed using the Kaplan-Meier method. The median survival rates will be reported with a 95% confidence interval. Median follow-up will be calculated using the reverse Kaplan-Meier method.|From the date of inclusion to the date of death from any cause, assessed up to 4 years||||months||95% Confidence Interval|Median
2670901|NCT01481129|Secondary|Duration of Response|Described in responding subjects using descriptive statistics (median, extreme values, etc.).|up to 4 years|No responses were observed||||||
2670902|NCT01481129|Primary|Objective Response Rate According to the International Response Criteria for DLBCL (Cheson 2007)|Rate of CR + PR according to Cheson 2007 after 4 months of treatment|Up to 4 months||||objective response|||Number
2670903|NCT01481116|Secondary|Change From Baseline in Fasting Plasma Glucose at Weeks 26, 52, 78 and 104|The change between the fasting plasma glucose value to be collected at Weeks 26, 52, 78 and 104 relative to baseline.|Baseline and Weeks 26, 52, 78 and 104|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period.|||milligram per deciliter (mg/dL)||Standard Error|Least Squares Mean
2670904|NCT01481116|Secondary|Percentage of Participants With HbA1c <7% for Participants Who Did Not Report Hypoglycemia||Weeks 26, 52, 78 and 104|Data for this outcome measure was not analyzed as prespecified in the protocol.||||||
2670905|NCT01481116|Secondary|Percentage of Participants With HbA1c <7%||Weeks 26, 52, 78 and 104|FAS included all randomized subjects who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period.|||percentage of participants|||Number
2670906|NCT01481116|Secondary|Change From Baseline in HbA1c at Weeks 26 and 52|The change in the value of HbA1c collected at Weeks 26 and 52 relative to baseline.|Baseline and Weeks 26 and 52|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2670907|NCT01481116|Secondary|Change From Baseline in Body Weight at Weeks 78 and 104|The change between the body weight to be collected at Weeks 78 and 104 relative to baseline.|Baseline and Weeks 78 and 104|FAS included all randomized participants who received at least 1 dose of double-blind study medication and who had a baseline and at least 1 post- baseline value during the double-blind treatment period. Data for body weight was not available at Week 104 due to early termination of the study.|||kg||Standard Error|Least Squares Mean
2670908|NCT01481116|Secondary|Percentage of Participants With Hypoglycemia|Participants were provided diaries to document any hypoglycemic events that occurred between study visits. Any experience of hypoglycemic signs and symptoms (regardless of the blood glucose value by glucometer) or had a blood glucose value less than or equal to (<=) 70 milligram per deciliter (mg/dL) (3.9 millimole per liter (mmol/L) by glucometer (regardless of symptoms) were to be recorded.|Day 1 up to Weeks 78 and 104|Safety analysis set included all participants who received at least 1 dose of double-blind study medication. Participants were analyzed according to the study medication they received.|||percentage of participants|||Number
2671467|NCT01475955|Secondary|AK Clearance Rate|"AK Clearance Rate (AKCR) for a subject is defined as:~100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]"|Baseline, Week 8||||percent clearance||Standard Deviation|Median
2670913|NCT01480674|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The data was reported for prospective period.|Up to 1 year|The safety population set included of all participants who received at least one dose of study drug. Participants with available data in the prospective period were analysed.|||Participants|||Number
2670914|NCT01480674|Secondary|Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment|Antineoplastic treatment given in combination with and after discontinuation (Aft. Dis) of herceptin treatment included chemotherapy and hormonotherapy.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at specified time points are denoted as ‘n’.|||Participants|||Number
2670915|NCT01480674|Secondary|Dosage Schedule of Herceptin Treatment|Participants who received trastuzumab are reported in the below table. The regimen of trastuzumab in first line treatment is presented as in frequency 1 infusion (inf) per week (W) and dose per infusion as mg/kg.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at specified time points are denoted as ‘n’.|||Participants|||Number
2670916|NCT01480674|Secondary|Overall Survival|The overall survival (OS) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the death from any cause.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures.|||Years||95% Confidence Interval|Median
2670917|NCT01480674|Secondary|Time to Progression|The Time to progression (TTP) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the date of the first progressive disease.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures.|||Years||95% Confidence Interval|Median
2670918|NCT01480674|Secondary|Progression-free Survival|The Progression-free survival (PFS) was defined as the time between the treatment start date (date of first trastuzumab infusion during the metastatic period) and the date of the first progressive disease or death from any cause. The method of assessment of disease progression was not outlined within the protocol, this was completed by each investigator in line with routine practice.|Up to 12 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures.|||Years||95% Confidence Interval|Median
2670919|NCT01480674|Primary|Percentage of Participants With Prevalence of Bone Metastases Without Progression for at Least 3 Years After the Beginning of 1st Line Herceptin Treatment|Bone metastasis occurs when cancer cells spread from their original site to a bone. Percentage of participants with prevalence of bone metastases without progression were reported|Up to 3 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at the time of evaluation were reported.|||Percentage of participants||95% Confidence Interval|Number
2670920|NCT01480674|Primary|Tumor Hormone Receptor Status of Participants Without Progression|The clinical and tumor characteristics including HER2 and Hormone Receptor (HR) status of metastatic breast cancer participants are analysed which are important factors which impact on Progression Free Survival.|Up to 3 years|Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at the time of evaluation were reported.|||Percentage of participants||95% Confidence Interval|Number
2670921|NCT01480596|Secondary|Mean Change From Baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at Week 28, Week 32 and Week 36|The total MG-ADL score was calculated by adding the score of each of the 8 individual MG-ADL questions. Possible total MG-ADL scores range from 0 (normal) to 24 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participant's last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-Baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MG-ADL Score, Treatment by Visit, and Baseline MG-ADL Score by Visit. Only follow-up visits are presented but the analysis also includes all treatment phase visits. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.|Baseline, Week 28, Week 32 and Week 36|ITT Population.|||Units on a scale||Standard Error|Least Squares Mean
2670922|NCT01480596|Secondary|Mean Change From Baseline in the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) at Week 12 and Week 24|The total MG-ADL score was calculated by adding the score of each of the 8 individual MG-ADL questions. Possible total MG-ADL scores ranges from 0 (normal) to 24 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MG-ADL Score, Treatment by Visit, and Baseline MG-ADL Score by Visit. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.|Baseline, Week 12 and Week 24|ITT Population.|||Units on a scale||Standard Error|Least Squares Mean
2670923|NCT01480596|Secondary|Number of Participants With MGFA-PIS (Unchanged, Improved, Worsened) at Week 24 and Week 36|Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being unchanged, improved or worsened.|Week 24 and Week 36|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.||||||
2670924|NCT01480596|Secondary|Number of Participants With MGFA-PIS of Pharmacologic Response Sustained Response (PR at Week 12 and Maintained the Response Through Week 24)|Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.|Week 12 through Week 24|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.||||||
2670925|NCT01480596|Secondary|Number of Participants With MGFA-PIS of Minimal Manifestation Sustained Response (MM at Week 12 and Maintained the Response Through Week 24)|Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.|Week 12 through Week 24|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.||||||
2670926|NCT01480596|Secondary|Number of Participants With MGFA-PIS of Pharmacologic Remission or Better at Week 24 and Week 36|Myasthenia Foundation of America (MGFA) post intervention status (PIS) assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.|Week 24 and Week 36|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.||||||
2670927|NCT01480596|Secondary|Number of Participants With a Myasthenia Foundation of America-post Intervention Status (MGFA-PIS) of Minimal Manifestation or Better at Week 24 and Week 36.|Myasthenia Foundation of America-post intervention status assesses whether subjects can be categorized as being in a status of Minimal Manifestation (MM), Pharmacologic Remission (PR) or Complete Remission (CR). Only MM and PR were assessed in this study as CR is not achievable based on the definition.|Week 24 and Week 36|The Reporting and Analysis Plan pre-specified that these analyses would not be conducted since during a review of blinded data it was identified that the MGFA scale had been inconsistently performed across sites and any statistical analyses would not be interpretable.||||||
2670928|NCT01480596|Secondary|Mean Change From Baseline for MGC Score at Week 28, Week 32 and Week 36|The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participant's last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-BL value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MGC Score, Treatment by Visit, and Baseline MGC Score by Visit. Only follow-up visits are presented but the analysis also includes all treatment phase visits. Only those participants available at the indicated time points (represented by n=X in the category titles) were analyzed.|Baseline, Week 28, Week 32 and Week 36|ITT Population.|||Units on a scale||Standard Error|Least Squares Mean
2670929|NCT01480596|Secondary|Median Time to MGC Response Which is Sustained From Earliest Time Point at Which Improvement by >=3 Points From Baseline is Observed and Maintained Through Week 24|A sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants' last available assessment prior to initiation of study intravenous (IV) infusion.|Baseline and up to Week 24|As per the criteria documented in the Reporting and Analysis Plan these analyses were not conducted since <50% of subjects met the criteria (i.e. had the event in question).||||||
2670930|NCT01480596|Secondary|Number of Participants With a Sustained Response in the MGC Score|AA sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Odds ratios are calculated by Cochran-Mantel-Haenszel method without adjusting for any strata. Wald confidence intervals and p-values were presented.|Baseline and up to Week 24|ITT Population.|||Number of participants|||Number
2670931|NCT01480596|Secondary|Number of Participants Worsening by >=3 Points From Baseline Through to Week 24 in the MGC Score|The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Proportions compared using exact analyses stratified by the observed median baseline score (<= median, > median). Exact odds ratios, double the exact one-sided p-values and exact confidence intervals were presented. Participants with missing data were assumed to have a worsening response.|Baseline and up to Week 24|ITT Population.|||Number of participants|||Number
2670932|NCT01480596|Secondary|Number of Participants With Improvement by >=3 Points From Baseline Through to Week 24 in the MGC Score|The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Proportions compared using exact analyses stratified by the observed median baseline score (<= median, > median). Exact odds ratios, double the exact one-sided p-values and exact confidence intervals were presented. Participants with missing data were assumed to have a negative response.|Baseline and up to Week 24|ITT Population.|||Number of participants|||Number
2670933|NCT01480596|Secondary|Mean Change From Baseline in Myasthenia Gravis Composite (MGC) Scale Through to Week 24|The total MGC score was calculated by adding the score of each of the 10 individual MGC questions. Possible total MGC scores range from 0 (normal) to 50 (severe). A lower score indicates a better clinical outcome. Baseline is defined as the participants last available assessment prior to initiation of study IV infusion. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline MGC Score, Treatment by Visit, and Baseline MGC Score by Visit.|Baseline and up to Week 24|ITT Population.|||Units on a scale||Standard Error|Least Squares Mean
2670934|NCT01480596|Secondary|Mean Change From Baseline for QMG Score at Week 28, Week 32 and Week 36|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. Total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (mild) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at baseline (BL) is the average of the screening and Week 0 BL scores. Change from BL was calculated by subtracting the BL value from the post-BL value. The differences in adjusted least square means are presented (Belimumab 10 mg/kg minus Placebo). A negative trt difference indicates benefit relative to placebo. Analysis method was Mixed-Model Repeated Measures adjusted for Trt, Visit, BL QMG Score, Trt by Visit and BL QMG Score by Visit. Only follow-up visits are presented but the analysis also includes all trt phase visits. Only those par. available at indicated time points (represented by n=X in the category titles) were analyzed.|Baseline, Week 28, Week 32 and Week 36|ITT Population.|||Units on a scale||Standard Error|Least Squares Mean
2670935|NCT01480596|Secondary|Median Time to QMG Response Which is Sustained From Earliest Time Point at Which Improvement by >=3 Points From Baseline is Observed and Maintained Through Week 24|A sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores.|Baseline and up to Week 24|As per the criteria documented in the Reporting and Analysis Plan these analyses were not conducted since <50% of subjects met the criteria (i.e. had the event in question).||||||
2670936|NCT01480596|Secondary|Number of Participants With a Sustained Response in the QMG Score|A sustained response during the treatment phase is when a participant improves by >=3 points from Baseline at Week 12, and the participant maintains at least a 3 point improvement from Baseline through Week 24. The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Odds ratios are calculated by Cochran-Mantel-Haenszel method stratified by the observed median baseline score (<= median, > median). Wald confidence intervals and p-values were presented.|Baseline and up to Week 24|ITT Population.|||Number of participants|||Number
2670937|NCT01480596|Secondary|Number of Participants Worsening by >=3 Points in QMG Score From Baseline Through to Week 24|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Proportions compared using exact analyses stratified by the observed median Baseline score (<=median, > median). Exact odds ratio, double the exact one-sided p-value and exact confidence interval were presented. Participants with missing data were assumed to have a worsening response.|Baseline and up to Week 24|ITT Population.|||Number of participants|||Number
2670938|NCT01480596|Secondary|Number of Participants With Improvement by Greater Than or Equal to (>=) 3 Points From Baseline Through to Week 24 in the QMG Score|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Proportions compared using exact analyses stratified by the observed median Baseline score (less than or equal to [<=] median, greater than [ >] median). Exact odds ratio, double the exact one-sided p-value and exact confidence intervals were presented. Participants with missing data were assumed to have a negative response.|Baseline and up to Week 24|ITT Population.|||Number of participants|||Number
2670950|NCT01480284|Secondary|Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 24, Week 48 and Week 96|The number of participants with serum HBV DNA level less than the lower limit of quantitation (i.e. 2.1 log10 copies/mL) at Week 24, Week 48 and Week 96 were summarized. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population|||Participants|||Number
2671092|NCT01479868|Secondary|Percentage of Participants With On-treatment Failure|Participants were considered as an on-treatment failure if, at actual end of treatment (EOT), there was confirmed detectable HCV RNA levels.|Week 1 to 48|The ITT population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2670939|NCT01480596|Primary|Mean Change From Baseline for Quantitative Myasthenia Gravis (QMG) Score at Week 24|The QMG is a 13 item ordinal scale which measures ocular, bulbar, extremity fatigue and strength, along with respiratory function. The total QMG score was calculated by adding the score of each of the 13 individual QMG questions. Possible scoring on the QMG range from 0 (normal) to 39 (severe). A lower score indicates a better clinical outcome. The QMG score at Baseline is the average of the screening and Week 0 Baseline scores. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. The differences in adjusted least square means were presented (Belimumab 10 mg/kg minus Placebo). A negative treatment difference indicates benefit relative to placebo. The analysis method was Mixed-Model Repeated Measures adjusted for Treatment, Visit, Baseline QMG Score, Treatment by Visit, and Baseline QMG Score by Visit.|Baseline and Week 24|Intent-to-Treat (ITT) Population includes participants in the Safety Population who has provided any post treatment efficacy assessment.|||Units on a scale||Standard Error|Least Squares Mean
2670940|NCT01480297|Primary|Intra-epidermal Nerve Fiber Density (IENFD) Fibers Per mm|Intra-epidermal Nerve Fiber Density (IENFD) was measured at two anatomic locations (thigh and ankle) at baseline and after 12 weeks of treatment with Salsalate. IENFD is expressed as fibers per mm. Means and standard deviations are shown.|Baseline and 12 weeks|Type 1 diabetes with painful neuropathy|||fibers per mm||Standard Deviation|Mean
2670941|NCT01480284|Secondary|Number of Participants With Resistance Related Mutations at Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to Throughout the Study)|"The development of drug resistance-related (RA) mutations was analyzed to look for resistance to Lamivudine (LAM), Adefovir dipivoxil (ADV), and/or ETV in a case where a virologic breakthrough has been observed after starting the study treatment (serum HBV DNA level has increased from the nadir by at least 1 log10 copies/mL) or where the serum HBV DNA level is not less than the HBV DNA detection limit (2.1 log10 copies/mL) at Week 24, Week 48 and Week 96. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV-DNA levels from on-treatment nadir. Participants who achieved the HBV-DNA values below lower limit of quantification (LLQ) (< 2.1 log10 copies/mL) in quantitative analysis at entire the study were also considered Negative in drug-resistance without implementation of genotypic analysis. Resistance mutation values were presented from Baseline to throughout the study. Baseline is defined as the value at Week 0 visit."|Screening, Week 24, Week 48, Week 96 and Virological Breakthrough (Baseline to throughout the study)|FAS Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||Participants|||Number
2670942|NCT01480284|Secondary|Number of Participants With Virological Breakthrough Through End of the Study|The number of participants who experienced virological breakthrough was summarized. Virological breakthrough is defined as serum HBV DNA level increase >=1 log10 copies/mL above the treatment nadir. Virological breakthrough values were presented from Baseline to through out the study. Baseline is defined as the value at Week 0 visit.|From Baseline to throughout study|FAS Population|||Participants|||Number
2670943|NCT01480284|Secondary|Number of Participants Achieving Each Indicated HBcrAg Category at Baseline, Week 24, Week 48 and Week 96|The number of participants achieving each indicated hepatitis B core-related antigen (HBcrAg) category (HBcrAg <3.0, 3.0 to 4.0, 4.0 to 5.0, 5.0 to 6.0, and >=6.0) (Log kilo unit per liter [KU/L]) by study visit was summarized. The LOCF method was applied for missing values.|Baseline, Week 24, Week 48 and Week 96|FAS Population|||Participants|||Number
2670944|NCT01480284|Secondary|Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96|The number of participants achieving each indicated HBsAg category (HBsAg <80, 80 to 800, 800 to 8000, 8000 to 80000, and >=80000) (kilo international unit per liter [KIU/L]) by study visit was summarized. The LOCF method was applied for missing values.|Baseline, Week 24, Week 48 and Week 96|FAS Population|||Participants|||Number
2670945|NCT01480284|Secondary|Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96|The number of participants with HBsAg/hepatitis B surface antibody (HBsAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBsAg and negative HBsAb participants at Baseline were summarized. HBsAg seroconversion .is defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population. Only participants with positive HBsAg and negative HBsAb at Baseline were analyzed.|||Participants|||Number
2670946|NCT01480284|Secondary|Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96|The number of participants with hepatitis B surface antigen (HBsAg) loss at Week 24, Week 48 and Week 96 in positive HBsAg participants at Baseline were summarized. Loss of HBsAg is defined as change of detectable HBsAg from positive to negative. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population.|||Participants|||Number
2670947|NCT01480284|Secondary|Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96|The number of participants achieving HBeAg/hepatitis Be antibody (HBeAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBeAg and negative HBeAb participants at Baseline were summarized. Seroconversion to HBeAg is defined as the change of detectable antibody to HBeAg from negative to positive. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population. Only participants with positive HBeAg and negative HBeAb at Baseline were analyzed.|||Participants|||Number
2670948|NCT01480284|Secondary|Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96|The number of participants achieving hepatitis Be antigen (HBeAg) loss at Week 24, Week 48 and Week 96 in positive HBeAg participants at Baseline were summarized. Loss of HBeAg is defined as the change of detectable HBeAg from positive to negative. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population. Only participants with positive HBeAg at Baseline were analyzed.|||Participants|||Number
2670949|NCT01480284|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96|The number of participants with alanine aminotransferase (ALT) normalization at Week 24, Week 48 and Week 96 were summarized. ALT normalization is defined as when an ALT value exceeds the upper limit of normal range (ULN) at Baseline and within the normal range at the end of treatment. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|Biochemically Evaluable Population (BEP): all participants who received at least one dose of IP and with an abnormal ALT at Baseline. The population for the analysis of ALT normalization was all participants with an ALT value > ULN at Baseline.|||Participants|||Number
2670951|NCT01480284|Secondary|Mean Change From Baseline in Serum HBV DNA Level at Week 48 and Week 96|The mean change from Baseline in the HBV DNA level at Week 48 and Week 96 were assessed (lower limit of quantitation : 2.1 log10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-baseline value minus the Baseline value. The LOCF method was applied for missing values.|Baseline, Week 48 and Week 96|Full Analysis Set (FAS) Population: all participants who entered into the study, received at least one dose of investigational product, and have at least one efficacy assessment after the treatment initiation.|||log10 copies/mL||Standard Deviation|Mean
2670952|NCT01480284|Primary|Mean Change From Baseline in Serum HBV DNA Level at Week 24|The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24 was assessed (lower limit of quantitation : 2.1 log 10 copies/mL). The mean values were adjusted by Baseline HBV DNA levels. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 24|Per Protocol Set (PPS) Population: all participants who received at least 1 dose of investigational product (IP) and had at least one efficacy assessment after the treatment initiation, and with no major protocol violations. Missing values observed during the treatment period were imputed by the last observation carried forward (LOCF) method.|||log10 copies/milliliter (copies/mL)||Standard Error|Least Squares Mean
2670953|NCT01480258|Secondary|Percentage of Participants Reporting Solicited Adverse Events (AEs) From D1 to D5 After Any Vaccination|Solicited systemic AEs were defined as crying, decreased appetite, irritability, pyrexia (rectal temperature ≥38.0°C), somnolence, and vomiting occurring from D1 to D5 after vaccination. The investigator had to assess whether these systemic AEs were related or not to the vaccines. All (related and unrelated) are displayed here.|Up to 5 days (from D1 to D5 after any vaccination)|All randomised participants who received at least 1 vaccination and who had safety follow-up.|||Percentage of participants|||Number
2670954|NCT01480258|Secondary|Percentage of Participants Reporting Unsolicited ISRs From D1 to D15 After Any Vaccination|Adverse events at injection sites were always considered as related to vaccine (Injection-Site Reactions {ISRs]). Unsolicited ISRs occurring from Day 1 (D1) to D15 after any vaccination were reported daily on the VRC by the parent(s) or legal representative. Unsolicited ISRs with incidence ≥1% are reported below.|From D1 to D15 after any vaccination|All randomised participants who received at least 1 vaccination and who had safety follow-up.|||Percentage of participants|||Number
2670955|NCT01480258|Secondary|Percentage of Participants Reporting Solicited ISRs From D1 to D5 After Any Vaccination|Adverse events at injection sites were always considered as related to vaccine (Injection-Site Reactions [ISRs]). Solicited ISRs were defined as injection-site erythema, injection-site pain, and injection-site swelling occurring from D1 to D5 after vaccination.|Up to 5 days (Day 1 to Day 5 following vaccination)|All randomised participants who received at least 1 vaccination and who had safety follow-up.|||Percentage of participants|||Number
2670956|NCT01480258|Secondary|Number of Participants Who Experienced an Adverse Event (AE) From Day 1 to Day 15 After Any Vaccination|Injection-site and systemic AEs were reported daily on the Vaccination Report Card (VRC) by the parent(s) or legal representative from Day 1 (D1) to D15 after each vaccination. Solicited injection site and systemic AEs were reported daily from D1 to D5 after each vaccination. AEs at injection sites were always considered as vaccine-related (V-related) (Injection-Site Reactions [ISRs]). The investigator had to assess whether systemic AEs were related or not to the vaccine. All AEs (related and unrelated) are displayed here.|Solicited AEs: up to 5 days (Days 1-5 after any vaccination); unsolicited AEs: up to 15 days (Day 1-15 after any vaccination)|All randomized participants who received at least 1 vaccination and who had safety follow-up.|||Percentage of participants|||Number
2670957|NCT01480258|Secondary|Non-inferiority of Rotavirus Response (Geometric Mean Titer, GMT) One Month After the 2nd Dose of Rotarix (4 Months of Age) Administered Concomitantly With PR5I Versus INFANRIX Hexa|Antibody titres expressed in units/mL were measured for Rotavirus IgA by Enzyme Immunoassay (EIA), 1 month after the 2nd dose of Rotarix, administered concomitantly with PR5I or INFANRIX hexa (Post-Dose 2). The 95% CI for GMT was based on the t-distribution of the natural log-transformed antibody titer.|1 month after the 2nd dose of Rotarix, administered concomitantly with PR5I or INFANRIX hexa (Post-Dose 2)|Participants who received dose 2 of Rotarix.|||Titre (units/mL)||95% Confidence Interval|Geometric Mean
2670958|NCT01480258|Secondary|Non-inferiority Ab Response Rates to PR5I Antigens One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) as Compared With INFANRIX Hexa|Percentage of participants with pre-specified Ab titre for PRP, HBsAg, diphtheria, tetanus, IPV1, 2 & 3, and percentage of pertussis seroresponder participants (PT, FHA, FIM and PRN) 1 month post-toddler dose were calculated based on the method by Miettinen and Nurminen stratified by country. Seroresponse was defined: (1) If pre-Dose 1 Ab cc was <LLOQ, post-vaccination Ab cc was ≥LLOQ, (2) If pre-Dose 1 Ab cc was ≥LLOQ, post-vaccination Ab cc was ≥pre-vaccination levels. Due to the timing of the occurrence of protocol violation or the availability of each antigen serology testing result, the analysis populations may not have been identical for each antigen-specific analysis at each post-vaccination visit.|1 month after Toddler dose (post-toddler dose)|Participants who met the inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and had a blood draw sample window of Days 28 to 51 following the Toddler dose.|||Percentage of participants|||Number
2670959|NCT01480258|Secondary|Superiority of Antibody (Ab) Response Rates to Haemophilus Influenzae Type b (PRP) One Month After the 2nd Dose of PR5I (4 Months of Age) as Compared With INFANRIX Hexa|Percentage of participants with an Ab titre ≥1.0 μg/mL for Hib (polyribosylribitol phosphate, PRP) measured by RIA 1 month post-infant dose 2 of PR5I or INFANRIX hexa.|1 month after the 2nd dose (post-infant dose 2)|Participants who received 2nd dose in the Infant series and had a blood draw sample window of Days 28 to 51 post-infant dose 2.|||Percentage of participants|||Number
2670960|NCT01480258|Secondary|Non-inferiority of Antibody (Ab) Response Rate to Haemophilus Influenzae Type b (PRP) One Month After the 2nd Dose of PR5I (4 Months of Age) as Compared With INFANRIX Hexa|Percentage of participants with an Ab titre ≥1.0 μg/mL for Hib (polyribosylribitol phosphate, PRP) measured by radioimmunoassay (RIA) 1 month post-infant dose 2 of PR5I or INFANRIX hexa.|1 month after the 2nd dose (post-infant dose 2)|Participants who received 2nd dose in the Infant series and had a blood draw sample window of Days 28 to 51 post-infant dose 2.|||Percentage of participants|||Number
2671124|NCT01479595|Secondary|Number of Participants With Anti-QAX576 Antibodies or Anti-VAK694 Antibodies|Anti-QAX576 and anti-VAK694 antibodies in serum were analyzed.|12 weeks|All randomized participants|||Participants|||Number
2670961|NCT01480258|Primary|Acceptability of Antibody (Ab) Response or Seroresponse Rates to All Antigens Contained in PR5I Vaccine One Month After the Toddler Dose of PR5I (11 to 12 Months of Age)|Acceptability response rates were defined as Ab titre ≥1.0 μg/mL for Haemophilus influenzae type b (Hib) (polyribosylribitol phosphate, PRP); ≥10 mIU/mL for Hepatitis (HBsAg); ≥0.1 IU/mL for diphtheria and tetanus; ≥8 (1/dil) for inactive poliovirus type (IPV) 1, 2 & 3, and percentage of pertussis seroresponder participants (Pertussis toxoid [PT], Filamentous haemagglutinin [FHA], Fimbriae types 2 & 3 [FIM] and Pertactin [PRN]) 1 month Post-Toddler dose of PR5I. Seroresponse was defined: (1) If pre-Dose 1 Ab concentration (cc) was <LLOQ (lower limit of quantitation), postvaccination Ab cc was ≥LLOQ, (2) If pre-Dose 1 Ab cc was ≥LLOQ, postvaccination Ab cc was ≥prevaccination levels. Due to the timing of the occurrence of protocol violation or the availability of each antigen serology testing result, the analysis populations may not have been identical for each antigen-specific analysis at each post-vaccination visit.|1 month after Toddler dose of PR51 (post-toddler dose)|Participants who met the inclusion criteria, were not protocol violators, received PR51 vaccinations within acceptable day ranges, and had a blood draw sample window of Days 28 to 51 following the Toddler dose. Participants receiving INFANRIX™ hexa were excluded from the acceptability analyses.|||Percentage of participants||95% Confidence Interval|Number
2670962|NCT01480232|Secondary|Effects of EVP-6124 on Working Memory as Measured by the N-Back Task Reaction Time|This task is a standard measure that can assess working memory performance under varying levels of task demand. Subjects are presented with a stream of stimuli, and the task is to decide for each stimulus whether it matches the one presented N items before. The processing load can be varied systematically by manipulating the value of N, which is expressed with changes in accuracy and reaction time. The number of errors as well as reaction times increase monotonically with increasing levels of N. The n-back task is sensitive to nicotine administration and abstinence effects. Here we present reaction time (RT)|Baseline, week 1, week 12||||mili seconds||Standard Deviation|Mean
2670963|NCT01480232|Secondary|Safety and Tolerability of EVP-6124 Alone or Combined With NRT|All AEs (adverse experiences) spontaneously reported by subjects and/or observed by investigator and evaluation of physical examinations, prior and concomitant medications, clinical laboratory tests, ECGs, and vital signs measurements. Data was collected at every visit and was analyzed as aggregate at the end of week 12|Weeks 1-12||||Participants|||Count of Participants
2670964|NCT01480232|Secondary|Effects of EVP-6124 on Cognitive Performance as Measured by the Continuous Performance Test Hit Reaction Time|The Continuous Performance Test (CPT) is a measure of both vigilance/attentional control and response inhibition. During the task, subjects are required to press a button whenever a letter appears on the screen unless that letter is an 'X'. Measures of attentional control will serve as primary measure from this test. Baseline attentional impairment is associated with reduced odds of abstinence, abstinence differentially worsens performance on this measure in those with baseline attentional impairment, and NRT improves performance on a similar measure.|Baseline, week 1, week 12||||mili seconds||Standard Deviation|Mean
2670965|NCT01480232|Primary|Difference in Expired Carbon Monoxide (CO) Concentration From Baseline to End Point|CO concentration was measured at every visit.|Baseline, Weeks 1, 2, 4, 6, 8, 10, 12||||part per million||Standard Deviation|Mean
2670966|NCT01480232|Primary|Effects of EVP-6124 on 7-day Point-prevalence Smoking Abstinence|Smoking abstinence is defined as a self-report of smoking no cigarettes for the past 7 days by time-line follow-back, confirmed by expired carbon monoxide (CO) <10 ppm and/or urine cotinine <50 ng/mL.|Week 1, 2, 4, 6, 8, 10, 12|The primary smoking cessation variable is biochemically verified self-report of 7-day point prevalence abstinence at 12 weeks (end of treatment).|||% participants with 7-Day Point Prevalen|||Number
2670967|NCT01480219|Primary|Number of Participants Who Developed Non-Melanoma Skin Cancer (NMSC)||Baseline until non-melanoma skin cancer diagnosis, loss-to-follow-up due to death or termination of the health plan or end of the study, assessed up to Year 8|Final analysis set included participants who met the eligibility criteria.|||participants|||Number
2670968|NCT01480180|Secondary|Volume of Distribution at Steady State (Vss)|Apparent volume of distribution at steady state is a product of the mean residence time and clearance and was calculated using the formula - Vss = CL x MRT. This was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.|Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
2670969|NCT01480180|Secondary|Mean Residence Time (MRT)|MRT = AUMC/AUC(0-inf), where AUMC is the area under the first moment curve, i.e. the area under the curve t∙C(t), calculated with the same method as AUC(0-inf) (linear trapezoidal method + extrapolated area). This was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.|Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Hour (h)||Geometric Coefficient of Variation|Geometric Mean
2670970|NCT01480180|Secondary|Clearance (CL)|Total plasma clearance (CL) of drug after intravenous administration was reported. Clearance was calculated using the formula CL= Dose / AUC(0-inf). This was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.|Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
2670984|NCT01480180|Secondary|Change in Pulse: After Approximately 25 Months|The mean change in the pulse values of participants was reported. The summary of change was based on individual changes observed at visit 17 (approximately month 25) from visit 13 (approximately month 19).|After approximately 25 months|Results were based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Beats per min||Standard Deviation|Mean
2670971|NCT01480180|Secondary|Terminal Half Life (t1/2)|t½ = ln(2) / λz, where λz is the terminal elimination rate constant. The terminal elimination rate constant was estimated using linear regression on the terminal part of the log(activity) versus time profile. This was measured at Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.|Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Hour (h)||Geometric Coefficient of Variation|Geometric Mean
2670972|NCT01480180|Secondary|Area Under the Curve (AUC0-t)|Area under the plasma activity versus time profile from time zero to the last measurable activity (AUC0-t) was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.|Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||IU*h/mL||Geometric Coefficient of Variation|Geometric Mean
2670973|NCT01480180|Secondary|Area Under the Curve (AUC0-inf)|Area under the plasma activity versus time profile from time zero to infinity (AUC0-inf) was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. It is the measure of total plasma exposure. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.|Pre dose and 30 min, 1, 4, 12, 24, 48, 72 and 96 hours post dose at week 0 and week 28|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||IU*h/mL||Geometric Coefficient of Variation|Geometric Mean
2670974|NCT01480180|Secondary|Trough Level (Single Dose and Steady State)|Trough level was defined as the plasma FVIII activity recorded immediately before next dose is given. This was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.|Week 0, week 28|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||IU/mL||Geometric Coefficient of Variation|Geometric Mean
2670975|NCT01480180|Secondary|Incremental Recovery (Single Dose and Steady State)|Incremental recovery was defined as the dose-normalised activity recorded 30 min after end of injection. This was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator.|Week 0, week 28|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||[(U/mL)/(IU/kg)]||Geometric Coefficient of Variation|Geometric Mean
2670976|NCT01480180|Secondary|FVIII Activity 30 Min Post -Injection (C30min)|FVIII plasma activity was measured after 30 mins of injection. This was measured at two time points Visit 2a (Week 0) and visit 7 (Week 28) during the Main Phase of the study. Chromogenic assay was performed with normal human plasma (NHP) as a calibrator|Week 0, week 28|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||IU/mL||Geometric Coefficient of Variation|Geometric Mean
2670977|NCT01480180|Secondary|Change in Respiratory Rate: After Approximately 80 Months|Change in respiratory rate was not calculated in the extension phase 2 of the study since participants were allowed to change from Q4D to Q7D and vice versa.|After approximately 80 months|Data were not collected for this outcome measure.||||||
2670978|NCT01480180|Secondary|Change in Respiratory Rate: After Approximately 25 Months|The mean change in the respiratory rate (breaths/min) values of participants was reported. The summary of change was based on individual changes observed at visit 17 (approximately month 25) from visit 13 (approximately month 19).|After approximately 25 months|Results were based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Breaths/min||Standard Deviation|Mean
2670979|NCT01480180|Secondary|Change in Respiratory Rate: After Approximately 19 Months|The mean change in the respiratory rate values of participants was reported. The summary of change was based on individual changes observed at visit 13 (approximately 19 months) from visit 2a pre-dose (Month 0).|After approximately 19 months|Results were based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Breaths/min||Standard Deviation|Mean
2670980|NCT01480180|Secondary|Change in Body Temperature: After Approximately 80 Months|Change in body temperature was not calculated in the extension phase 2 of the study since participants were allowed to change from Q4D to Q7D and vice versa.|After approximately 80 months|Data were not collected for this outcome measure.||||||
2670981|NCT01480180|Secondary|Change in Body Temperature: After Approximately 25 Months|The mean change in the body temperature (C) values of participants was reported. The summary of change was based on individual changes observed at visit 17 (approximately month 25) from visit 13 (approximately month 19).|After approximately 25 months|Results were based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Degree celcius||Standard Deviation|Mean
2670982|NCT01480180|Secondary|Change in Body Temperature: After Approximately 19 Months|The mean change in the body temperature values of participants was reported. The summary of change was based on individual changes observed at visit 13 (approximately 19 months) from visit 2a pre-dose (Month 0).|After approximately 19 months|Results were based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Degree celcius||Standard Deviation|Mean
2670983|NCT01480180|Secondary|Change in Pulse: After Approximately 80 Months|Change in pulse was not calculated in the extension phase 2 of the study since participants were allowed to change from Q4D to Q7D and vice versa.|After approximately 80 months|Data were not collected for this outcome measure.||||||
2671236|NCT01478828|Primary|Number of Participants That Can Achieve 60% MYC Modulation Response|Number of participants who achieve V-myc Myelocytomatosis Viral Oncogene Homolog (MYC) down-regulation in prostatectomy specimens in intermediate-/high-risk localized prostate cancer patients.|1 year||||Participants|||Count of Participants
2670985|NCT01480180|Secondary|Change in Pulse: After Approximately 19 Months|The mean change in the pulse values of participants was reported. The summary of change was based on individual changes observed at visit 13 (approximately 19 months) from visit 2a pre-dose (Month 0).|After approximately 19 months|Results were based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Beats per min||Standard Deviation|Mean
2670986|NCT01480180|Secondary|Change in Blood Pressure: After Approximately 80 Months|Change in the blood pressure was not calculated in the extension phase 2 of the study since participants were allowed to change from Q4D to Q7D and vice versa.|After approximately 80 months|Data were not collected for this outcome measure.||||||
2670987|NCT01480180|Secondary|Change in Blood Pressure: After Approximately 25 Months|The mean change in the systolic and diastolic blood pressure values of participants was reported. The summary of change was based on individual changes observed at visit 17 (approximately month 25) from visit 13 (approximately month 19).|After approximately 19 and 25 months|Results were based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||mmHg||Standard Deviation|Mean
2670988|NCT01480180|Secondary|Change in Blood Pressure: After Approximately 19 Months|The mean change in the systolic and diastolic blood pressure values of participants was reported. The summary of change was based on individual changes observed at visit 13 (approximately 19 months) from visit 2a pre-dose (Month 0).|After approximately 19 months|Results were based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||mmHg||Standard Deviation|Mean
2670989|NCT01480180|Secondary|Number of Serious Adverse Events Reported During the Trial Period: After Approximately 80 Months|All presented serious adverse events (SAEs) are treatment-emergent. A treatment-emergent adverse event was defined as an event with onset after first N8-GP administration.|After approximately 80 months|Results are based on the SAS. SAS comprised all participants exposed to N8-GP in this trial.|||Number of serious adverse events|||Number
2670990|NCT01480180|Secondary|Number of Serious Adverse Events Reported During the Trial Period: After Approximately 25 Months|All presented serious adverse events (SAEs) are treatment-emergent. A treatment-emergent adverse event was defined as an event with onset after first N8-GP administration.|After approximately 25 months|Results are based on the SAS. SAS comprised all participants exposed to N8-GP in this trial.|||Number of serious adverse events|||Number
2670991|NCT01480180|Secondary|Number of Serious Adverse Events Reported During the Trial Period: After Approximately 19 Months|All presented serious adverse events (SAEs) are treatment-emergent. A treatment-emergent adverse event was defined as an event with onset after first N8-GP administration.|After approximately 19 months|Results are based on the SAS. SAS comprised all participants exposed to N8-GP in this trial.|||Number of serious adverse events|||Number
2670992|NCT01480180|Secondary|Number of Adverse Events Reported During the Trial Period: After Approximately 80 Months|The number of adverse events observed during the study after approximately 80 months was reported.|After approximately 80 months|Results are based on the SAS. SAS comprised all participants exposed to N8-GP in this trial.|||Number of adverse events|||Number
2670993|NCT01480180|Secondary|Number of Adverse Events Reported During the Trial Period: After Approximately 25 Months|All presented adverse events (AEs) are treatment-emergent. A treatment-emergent adverse event was defined as an event with onset after first N8-GP administration.|After approx. 25 months|Results are based on the SAS. SAS comprised all participants exposed to N8-GP in this trial.|||Number of adverse events|||Number
2670994|NCT01480180|Secondary|Number of Adverse Events Reported During the Trial Period: After Approximately 19 Months|All presented adverse events (AEs) are treatment-emergent. A treatment-emergent adverse event was defined as an event with onset after first N8-GP administration.|After approx 19 months|Results are based on the SAS. SAS comprised all participants exposed to N8-GP in this trial.|||Number of adverse events|||Number
2670995|NCT01480180|Secondary|Number of Bleeds Using Pain Medication|The mean number of bleeds using pain medication in the main phase of the study (approximately 19 months) were reported.|After approx 19 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Number of bleeds||Standard Deviation|Mean
2670996|NCT01480180|Secondary|Number of Participants Using Pain Medication|The number of participants using pain medication during the main plus extension phase 1 of the study (approximately 25 months) and during extension phase 2(approximately 80 months) were reported.|After approx 25 and 80 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Participants|||Count of Participants
2670997|NCT01480180|Secondary|Number of Days Using Mobility Aid|The mean number of days that participants used any aids for mobility during the study were reported.|Approx 19, 25 and 80 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Days||Standard Deviation|Mean
2670998|NCT01480180|Secondary|Number of Days Missing School or Work|The mean number of days that participants missed to go to school or work were reported.|Approx 19, 25 and 80 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Days||Standard Deviation|Mean
2670999|NCT01480180|Secondary|Number of Admissions to the Emergency Room (ER) During the Trial|The number of admissions to the ER that took place in the study were reported for each group.|After approx 19, 25 and 80 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||ER admissions|ER admissions||Count of Units
2671000|NCT01480180|Secondary|Number of Days at the Hospital During the Trial|The mean number of days that participants spent at the hospital during the study were reported.|After approx 19, 25 and 80 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Days||Standard Deviation|Mean
2671237|NCT01478620|Secondary|Time to First Early Recurrence [Days] After Clearance of uUTI Symptoms||During active treatment and follow up period (Day 0 - Day 37)|||||||
2671001|NCT01480180|Secondary|Number of Hospital Admissions During the Trial|The number of hospital admissions that took place in the study were reported.|After approx 19, 25 and 80 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Number of hospital admissions|Number of hospital admissions||Count of Units
2671002|NCT01480180|Secondary|Patient Reported Outcomes - Change in European Quality of Life Utility Index Scores: After Approximately 80 Months|Reported results are change from visit 1 (Month 0) upto end of Extension phase 2 (Month 80) of the study. Time intervals are assigned based on time after first dose. It is possible that a patient answers more than one questionnaire in a single time interval. Overall units analysed = Max no. of questionnaires answered by participants for this endpoint. Overall no. of participants analysed = max no. of participants analysed at each time point. This utility index has 5 dimensions: mobility, self-care, usual activities, pain/discomfort & anxiety/depression. Each dimension has 3 levels where 1 indicates better health state (no problems) and 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; a positive change indicates an improvement.|1-<2 yrs, 2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs|Results were based on the FAS which included all participants exposed to N8-GP in this trial.|||Scores on a scale|Number of questionnaires|Standard Deviation|Mean
2671003|NCT01480180|Secondary|Patient Reported Outcomes - Change in European Quality of Life Utility Index: After Approx 19 and 25 Months|Reported results are change from baseline (Month 0) measured at end of main phase (Month 19) and change from Month 19 to end of Extension 1 (Month 25) of the study. The European quality of life utility index comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels where 1 indicates better health state (no problems) and 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; a positive change indicates an improvement.|After approx 19 and 25 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Scores on a scale||Standard Deviation|Mean
2671004|NCT01480180|Secondary|Patient Reported Outcomes - Change in EQ-5D-VAS Scores: After Approximately 80 Months|Reported results are change from visit 1 (Month 0) upto end of Extension phase 2 (Month 80) of the study. Time intervals are assigned based on time after first dose. It was possible that a participant could answer more than one questionnaire in a single time interval. Overall number of units analysed = Maximum no of questionnaires answered by participants for this endpoint. Overall number of participants analysed = maximum number of participants contributed to the analysis for each time point. The EQ5D-VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. EQ-5D-VAS: range 0 to 100. A higher score indicates better self reported health status. A positive change indicates an improvement.|1-<2 yrs, 2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs|Results were based on the FAS which included all participants exposed to N8-GP in this trial.|||Scores on a scale|Number of questionnaires|Standard Deviation|Mean
2671005|NCT01480180|Secondary|Patient Reported Outcomes - Change in EQ-5D-VAS Scores: After Approx 19 and 25 Months|Reported results are change from baseline (Month 0) measured at end of main phase (Month 19) and change from Month 19 to end of Extension 1 (Month 25) of the study. The European quality of life visual analogue scale (EQ5D-VAS) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement. EQ-5D-VAS: range 0 to 100. A higher score indicates better self reported health status. A positive change indicates an improvement.|After approx 19 and 25 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Scores on a scale||Standard Deviation|Mean
2671006|NCT01480180|Secondary|Patient Reported Outcomes - Change in HEMO-SAT (Parents) Scores: After Approximately 80 Months|Reported results are from Visit 1 (Month 0), and change from visit 1 upto end of Extension phase 2 (Month 80) of the study. Time intervals are assigned based on time after first dose. It was possible that a participant could answer more than one questionnaire in a single time interval. Overall number of units analysed = Max. no of questionnaires answered by participants for this endpoint. Overall number of participants analysed = max. number of participants contributed to the analysis for each time point. The HEMO-SAT assessment included questions on treatment aspects including Ease and convenience, efficacy, burden, specialist/nurses, centre/hospital, general satisfaction. Adults completing the questionnaire could achieve a score from 0 to 100, with lower scores reflecting greater treatment satisfaction. The scale range for each of the 6 domains was 0-100 with lower scores reflecting greater treatment satisfaction. A decrease in the score would mean improvement.|2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs|Results were based on the FAS which included all participants exposed to N8-GP in this trial.|||Scores on a scale|Number of questionnaires|Standard Deviation|Mean
2671007|NCT01480180|Secondary|Patient Reported Outcomes - Change in HEMO-SAT Scores (Parents): After Approx 19 and 25 Months|The summary of change was based on individual changes observed at visit 13 (approximately 19 months) from visit 2a pre-dose (Month 0). The HEMO-SAT assessment included questions on treatment aspects including Ease and convenience, efficacy, burden, specialist/nurses, centre/hospital, general satisfaction (reported by parents). Adults completing the questionnaire could achieve a score from 0 to 100, with lower scores reflecting greater treatment satisfaction. The scale range for each of the 6 domains was 0-100 with lower scores reflecting greater treatment satisfaction. A decrease in the score would mean improvement.|After approx 19 and 25 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Scores on a scale||Standard Deviation|Mean
2671238|NCT01478620|Secondary|Proportion of Patients With Early Recurrence [Days] After Clearance of uUTI Symptoms||During active treatment and follow up period (Day 0 - Day 37)|||||||
2671239|NCT01478620|Secondary|Proportion of Patients Who Require Antibiotic Treatment Until Day 7||During active treatment period|||||||
2671008|NCT01480180|Secondary|Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approximately 80 Months|Reported results are change from visit 1 (Month 0) upto end of Extension phase 2 (Month 80) of the study. Time intervals are assigned based on time after first dose. It was possible that a participant could answer more than one questionnaire in a single time interval. Overall number of units analysed = Maximum no of questionnaires answered by participants for this endpoint. Overall number of participants analysed = maximum number of participants contributed to the analysis for each time point. The HEMO-SAT assessment included questions on treatment aspects including Ease and convenience, efficacy, burden, specialist/nurses, centre/hospital, general satisfaction (reported by patients). Adults completing the questionnaire could achieve a score from 0 to 100, with lower scores reflecting greater treatment satisfaction. The scale range for each of the 6 domains was 0-100 with lower scores reflecting greater treatment satisfaction. A decrease in the score would mean improvement.|1-<2 yrs, 2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs|Results were based on the FAS which included all participants exposed to N8-GP in this trial.|||Scores on a scale|Number of questionnaires|Standard Deviation|Mean
2671009|NCT01480180|Secondary|Patient Reported Outcomes - Change in HEMO-SAT (Patients) Scores: After Approx 19 and 25 Months|Reported results are change from baseline (Month 0) measured at end of main phase (Month 19) and change from Month 19 to end of Extension 1 (Month 25) of the study. The HEMO-SAT (Hematology-satisfaction) assessment included questions on treatment aspects including Ease and convenience, efficacy, burden, specialist/nurses, centre/hospital, general satisfaction (reported by patients). Adults completing the questionnaire could achieve a score from 0 to 100, with lower scores reflecting greater treatment satisfaction. The scale range for each of the 6 domains was 0-100 with lower scores reflecting greater treatment satisfaction. A decrease in the score would mean improvement.|After approx 19 and 25 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Scores on a scale||Standard Deviation|Mean
2671010|NCT01480180|Secondary|Patient Reported Outcomes - Change in HAEM-A-QOL (>=17 Years) Total Scores: After Approximately 80 Months|Reported results are change from visit 1 (Month 0) upto end of Extension phase 2 (Month 80) of the study. Time intervals are assigned based on time after first dose. It was possible that a participant could answer more than one questionnaire in a single time interval. Overall number of units analysed = Maximum no of questionnaires answered by participants for this endpoint. Overall number of participants analysed = maximum number of participants contributed to the analysis for each time point. The HAEM-A-QOL (for adults (>=17 years)) assessment included questions on physical health, feeling, view of yourself, sports and leisure, work and school, dealing with haemophilia, treatment, future, family planning, and partnership and sexuality. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia.|2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Scores on a scale|Number of questionnaires|Standard Deviation|Mean
2671011|NCT01480180|Secondary|Patient Reported Outcomes - Change in HAEM-A-QOL (>=17 Years) Total Scores: After Approx 19 and 25 Months|Reported results are change from baseline (Month 0) measured at end of main phase (Month 19) and change from Month 19 to end of Extension 1 (Month 25) of the study. The HAEM-A-QOL (for adults (>=17 years)) assessment included questions on questions on physical health, feeling, view of yourself, sports and leisure, work and school, dealing with haemophilia, treatment, future, family planning, and partnership and sexuality. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia.|After approx 19 and 25 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Scores on a scale||Standard Deviation|Mean
2671012|NCT01480180|Secondary|Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Parents of Patients 13-16 Years Old): After Approx 80 Months|Reported results are change from visit 1 (Month 0) upto end of Extension phase 2 (Month 80) of the study. The questionnaire was completed by parents of the patients in the 13-16 years old age bracket. Time intervals are assigned based on time after first dose. It was possible that a participant could answer more than one questionnaire in a single time interval. The HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Overall number of units analysed = Maximum no of questionnaires answered by participants for this endpoint. Overall number of participants analysed = maximum number of participants contributed to the analysis for each time point.|2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs|Results were based on the FAS which included all participants exposed to N8-GP in this trial. No participants from the 13-16 years age group received on-demand treatment. Thus on-demand treatment group is not applicable for this endpoint.|||Scores on a scale|Number of questionnaires|Standard Deviation|Mean
2671013|NCT01480180|Secondary|Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Parents of Patients 13-16 Years Old): After Approx 19 and 25 Months|Reported results are change from baseline (Month 0) measured at end of main phase (Month 19) and change from Month 19 to end of Extension 1 (Month 25) of the study. The questionnaire was completed by parents of the patients in the 13-16 years old age bracket. The HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia.|After approx 19 and 25 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data. No participants from the 13-16 years age group received on-demand treatment. Thus on-demand treatment group is not applicable for this endpoint.|||Scores on a scale||Standard Deviation|Mean
2671025|NCT01480180|Secondary|Consumption of N8-GP (Number of Infusions) During Prophylaxis and On-demand Treatment: After Approximately 80 Months|Number of infusions are presented as average dose used during prophylaxis and on-demand treatment.|After approximately 80 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of infusions used during prophylaxis and on-demand treatment.|||U/kg|Infusions|Standard Deviation|Mean
2671014|NCT01480180|Secondary|Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Patients 13-16 Years Old): After Approx 80 Months|Reported results are change from visit 1 (Month 0) upto end of Extension phase 2 (Month 80) of the study. Time intervals are assigned based on time after first dose. It was possible that a participant could answer more than one questionnaire in a single time interval. The HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia. Overall number of units analysed = Maximum no of questionnaires answered by participants for this endpoint. Overall number of participants analysed = maximum number of participants contributed to the analysis for each time point.|2-<3 yrs, 3-<4 yrs, 4-<5 yrs, 5-<6 yrs and 6-<7 yrs|Results were based on the FAS which included all participants exposed to N8-GP in this trial. No participants from the 13-16 years age group received on-demand treatment. Thus on-demand treatment group is not applicable for this endpoint.|||Scores on a scale|Number of questionnaires|Standard Deviation|Mean
2671015|NCT01480180|Secondary|Patient Reported Outcomes - Change in HAEMO-QOL Total Scores (Patients 13-16 Years Old) After Approx 19 and 25 Months|Reported results are change from baseline (Month 0) measured at end of main phase (approx Month 19) and change from Month 19 at end of Extension 1 (approx Month 25) of the study. The HAEMO-QOL assessment included questions on physical health, feeling, view of yourself, family, friends, perceived support, other persons, sports and school, dealing with haemophilia, treatment, future, and relationships. Scores range for each question was 0-100, with a lower score indicating better quality of life related to haemophilia.|After approx 19 and 25 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data. No participants from the 13-16 years age group received on-demand treatment. Thus on-demand treatment group is not applicable for this endpoint.|||Scores on a scale||Standard Deviation|Mean
2671016|NCT01480180|Secondary|Haemostatic Effect as Measured by Recovery and Trough Levels FVIII:C (in All Patients Receiving Prophylaxis Treatment): After Approximately 80 Months|Since patients were allowed to change prophylaxis regimen at any time during the extension phase part 2, and since the visit intervals were different for the 2 prophylaxis treatment regimens (Q4D and Q7D), FVIII activity data are reported only as incremental recovery at this timepoint.|After approximately 80 months|Data were not collected for this endpoint.||||||
2671017|NCT01480180|Secondary|Haemostatic Effect as Measured by Recovery and Trough Levels FVIII:C (in All Patients Receiving Prophylaxis Treatment): After Approximately 25 Months|Recovery and trough levels of FVIII:C was reported for all participants at the end of extension phase 1 study (approx. 25 months). The data was reported for all participants who received prophylaxis treatment. Chromogenic assay was performed with N8-GP product specific standard (PSS) as a calibrator.|After approximately 25 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||U/mL||Geometric Coefficient of Variation|Geometric Mean
2671018|NCT01480180|Secondary|Haemostatic Effect as Measured by Recovery and Trough Levels FVIII:C (in All Patients Receiving Prophylaxis Treatment): After Approximately 19 Months|Recovery and trough levels of FVIII:C was reported for all participants at Visit 3 (Week 4) and end of main phase (approx. 19 months). The data was reported for all participants who received prophylaxis treatment. Chromogenic assay was performed with N8-GP product specific standard (PSS) as a calibrator.|After approximately 19 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||U/mL||Geometric Coefficient of Variation|Geometric Mean
2671019|NCT01480180|Secondary|Consumption of N8-GP (U/kg Per Year) During Prophylaxis and On-demand Treatment: After Approximately 80 Months|The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per year per participant) was reported.|After approximately 80 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||U/kg per year||Standard Deviation|Mean
2671020|NCT01480180|Secondary|Consumption of N8-GP (U/kg Per Year) During Prophylaxis and On-demand Treatment: After Approximately 25 Months|The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per year per participant) was reported.|After approximately 25 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||U/kg per year||Standard Deviation|Mean
2671021|NCT01480180|Secondary|Consumption of N8-GP (U/kg Per Year) During Prophylaxis and On-demand Treatment: After Approximately 19 Months|The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per year per participant) was reported.|After approximately 19 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||U/kg per year||Standard Deviation|Mean
2671022|NCT01480180|Secondary|Consumption of N8-GP (U/kg Per Month) During Prophylaxis and On-demand Treatment: After Approximately 80 Months|The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per month per participant) was reported.|After approximately 80 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||U/kg per month||Standard Deviation|Mean
2671023|NCT01480180|Secondary|Consumption of N8-GP (U/kg Per Month) During Prophylaxis and On-demand Treatment: After Approximately 25 Months|The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per month per participant) was reported.|After approximately 25 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||U/kg per month||Standard Deviation|Mean
2671024|NCT01480180|Secondary|Consumption of N8-GP (U/kg Per Month) During Prophylaxis and On-demand Treatment: After Approximately 19 Months|The mean consumption of N8-GP used for treatment of a bleed from start to stop of a bleed (per month per participant) was reported.|After approximately 19 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||U/kg per month||Standard Deviation|Mean
2671026|NCT01480180|Secondary|Consumption of N8-GP (Number of Infusions) During Prophylaxis and On-demand Treatment: After Approximately 25 Months|Number of infusions are presented as average dose used during prophylaxis and on-demand treatment.|After approximately 25 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of infusions used during prophylaxis and on-demand treatment.|||U/kg|Infusions|Standard Deviation|Mean
2671027|NCT01480180|Secondary|Consumption of N8-GP (Number of Infusions) During Prophylaxis and On-demand Treatment: After Approximately 19 Months|Number of infusions are presented as average dose used during propphylaxis and on-demand treatment.|After approximately 19 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of infusions used during prophylaxis and on-demand treatment.|||U/kg|Infusions|Standard Deviation|Mean
2671028|NCT01480180|Secondary|Consumption of N8-GP Per Bleeding Episode (U/kg): After Approximately 80 Months|The mean consumption of N8-GP (U/kg) used for treatment of a bleed from start to stop of a bleed was reported.|After approximately 80 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of bleeds analysed.|||U/kg per bleed|Bleeding episodes|Standard Deviation|Mean
2671029|NCT01480180|Secondary|Consumption of N8-GP Per Bleeding Episode (U/kg): After Approximately 25 Months|The mean consumption of N8-GP (U/kg) used for treatment of a bleed from start to stop of a bleed was reported.|After approximately 25 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of bleeds analysed.|||U/kg per bleed|Bleeding episodes|Standard Deviation|Mean
2671030|NCT01480180|Secondary|Consumption of N8-GP Per Bleeding Episode (U/kg): After Approximately 19 Months|The mean consumption of N8-GP (U/kg) used for treatment of a bleed from start to stop of a bleed was reported.|After approximately 19 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of bleeds analysed|||U/kg per bleed|Bleeding episodes|Standard Deviation|Mean
2671031|NCT01480180|Secondary|Consumption of N8-GP Per Bleeding Episode (Number of Infusions): After Approximately 80 Months|The mean number of infusions of N8-GP used for treatment of a bleed from start to stop of a bleed was reported.|After approximately 80 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of infusions in respective arm.|||Number of infusions|Infusions|Standard Deviation|Mean
2671032|NCT01480180|Secondary|Consumption of N8-GP Per Bleeding Episode (Number of Infusions): After Approximately 25 Months|The mean number of infusions of N8-GP used for treatment of a bleed from start to stop of a bleed was reported.|After approximately 25 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of infusions in respective arm.|||Number of infusions|Infusions|Standard Deviation|Mean
2671033|NCT01480180|Secondary|Consumption of N8-GP Per Bleeding Episode (Number of Infusions): After Approximately 19 Months|The mean number of infusions of N8-GP used for treatment of a bleed from start to stop of a bleed was reported.|After approximately 19 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of infusions in respective arm.|||Number of infusions|Infusions|Standard Deviation|Mean
2671034|NCT01480180|Secondary|Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 80 Months|Haemostatic effect of N8-GP for treatment of bleeding episodes was assessed by 4-point response scale: none, moderate, good or excellent. Evaluation during trial was done by participant and/or parent(s)/caregiver within approximately 8 hours after a single injection as follows: Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within approximately 8 hrs after a single injection; Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hrs after a single injection, but possibly requiring more than one injection for complete resolution; Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection, but usually requiring more than one injection; None: No improvement, or worsening of symptoms.|After approximately 80 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of bleeds analysed.|||Bleeding episodes|Bleeding episodes||Count of Units
2671035|NCT01480180|Secondary|Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 25 Months|Haemostatic effect of N8-GP for treatment of bleeding episodes was assessed by 4-point response scale: none, moderate, good or excellent. Evaluation during trial was done by participant and/or parent(s)/caregiver within approximately 8 hours after a single injection as follows: Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within approximately 8 hrs after a single injection; Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hrs after a single injection, but possibly requiring more than one injection for complete resolution; Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection, but usually requiring more than one injection; None: No improvement, or worsening of symptoms.|After approximately 25 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of bleeds analysed.|||Bleeding episodes|Bleeding episodes||Count of Units
2671036|NCT01480180|Secondary|Haemostatic Effect of N8-GP When Used for Treatment of Bleeds, Assessed on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate and None): After Approximately 19 Months|Haemostatic effect of N8-GP for treatment of bleeding episodes was assessed by 4-point response scale: none, moderate, good or excellent. Evaluation during trial was done by participant and/or parent(s)/caregiver within approximately 8 hours after a single injection as follows: Excellent: Abrupt pain relief and/or clear improvement in objective signs of bleeding within approximately 8 hrs after a single injection; Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hrs after a single injection, but possibly requiring more than one injection for complete resolution; Moderate: Probable or slight beneficial effect within approximately 8 hours after the first injection, but usually requiring more than one injection; None: No improvement, or worsening of symptoms.|After approximately 19 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of bleeds analysed.|||Bleeding episodes|Bleeding episodes||Count of Units
2671240|NCT01478620|Secondary|Duration of uUTI Symptoms||During active treatment and follow up period (Day 0 - Day 37)|||||||
2671037|NCT01480180|Primary|Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 80 Months|Annualised bleeding rate (ABR) is the number of bleeding episodes per year reported during the prophylactic treatment with N8-GP.|After approximately 80 months|Results were based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Bleeds per participant per year||Inter-Quartile Range|Median
2671038|NCT01480180|Primary|Incidence Rate of FVIII-inhibitors ≥0.6 BU: At Approximately 80 Months|All participants with neutralizing antibodies were included in the numerator and any participant with a minimum 50 exposure days plus any participant with inhibitory inhibitors was included in the denominator. A positive inhibitor test was defined as ≥0.6 bethesda unit (BU). Estimates are based on exact calculations for a binomial distribution. For the calculation of the 'inhibitor rate' the nominator included all participants with neutralising antibodies while the denominator included all participants with a minimum of 50 exposures plus any participant with less than 50 exposures but with neutralising inhibitors.|At approximately 80 months|Results are based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Inhibitor rate|||Number
2671039|NCT01480180|Primary|Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 25 Months|ABR is the number of bleeding episodes per year. This was assessed only for the prophylaxis treatment with N8-GP.|After approximately 25 months|Results are based on the FAS which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Bleeds per participant per year||Inter-Quartile Range|Median
2671040|NCT01480180|Primary|The Incidence Rate of FVIII-inhibitors ≥0.6 BU: After Approximately 25 Months|All participants with neutralizing antibodies were included in the numerator and any participant with a minimum 50 exposure days plus any participant with inhibitory inhibitors was included in the denominator. A positive inhibitor test was defined as ≥0.6 bethesda unit (BU). Estimates are based on exact calculations for a binomial distribution. For the calculation of the 'inhibitor rate' the nominator included all participants with neutralising antibodies while the denominator included all participants with a minimum of 50 exposures plus any participant with less than 50 exposures but with neutralising inhibitors.|After approximately 25 months|Results are based on the SAS. SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Inhibitor rate|||Number
2671041|NCT01480180|Primary|Annualised Bleeding Rate in the Prophylaxis Arm: After Approximately 19 Months|Annualised bleeding rate (ABR) is the number of bleeding episodes per year. This was assessed only for the prophylaxis treatment with N8-GP.|After approximately 19 months|Results were based on the full analysis set (FAS) which included all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Bleeds per participant per year||Inter-Quartile Range|Median
2671042|NCT01480180|Primary|The Incidence Rate of FVIII-inhibitors ≥0.6 BU: After Approximately 19 Months|All participants with neutralizing antibodies were included in the numerator and any participant with a minimum 50 exposure days plus any participant with inhibitory inhibitors was included in the denominator. A positive inhibitor test was defined as ≥0.6 bethesda unit (BU). Estimates are based on exact calculations for a binomial distribution. For the calculation of the 'inhibitor rate' the nominator included all participants with neutralising antibodies while the denominator included all participants with a minimum of 50 exposures plus any participant with less than 50 exposures but with neutralising inhibitors.|After approximately 19 months|Results are based on the safety analysis set (SAS). SAS comprised all participants exposed to N8-GP in this trial. Number analysed = Number of participants with available data for respective arm.|||Inhibitor rate|||Number
2671043|NCT01480089|Secondary|Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)|Participants are asked to rate their pain level using the visual analog scale (VAS). The VAS is a measurement of pain where respondents specify their level of pain by indicating a position along a continuous line between two end-points. The VAS used in this study was a horizontal line of 100 mm length anchored by two word descriptors - one word at each end: No pain (left end) and Very Severe Pain (right end). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The VAS range is 0 to 100.|12 hours after surgery|All individuals randomized are included in this analysis.|||millimeters||Standard Deviation|Mean
2671044|NCT01480089|Primary|Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)|Participants are asked to rate their pain level using the visual analog scale (VAS). The VAS is a measurement of pain where respondents specify their level of pain by indicating a position along a continuous line between two end-points. The VAS used in this study was a horizontal line of 100 mm length anchored by two word descriptors - one word at each end: No pain (left end) and Very Severe Pain (right end). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The VAS range is 0 to 100.|2 hours after surgery|All individuals randomized are included in this analysis.|||millimeters||Standard Deviation|Mean
2671045|NCT01480076|Secondary|Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)|AE: any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. SAE: any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the subject at immediate risk of death (a life threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could have jeopardized the subject or may have required intervention to prevent one of the other outcomes listed in the definition above.|From signing of Informed Consent (SAEs) or from first dose of study treatment (AEs) through Week 50 or Early Termination (14 +/- 7 days after last dose)|Intent-to-treat population: all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit.|||participants|||Number
2671125|NCT01479595|Secondary|Change From Baseline in Maximum Expiratory Flow|Maximum expiratory flow was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.|Baseline and 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.|||L/sec||Standard Deviation|Mean
2671241|NCT01478620|Secondary|Severity of uUTI Symptoms on Day 37||Day 37|||||||
2671046|NCT01480076|Secondary|Change From Baseline in Regular Activity Productivity Loss on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of activity impairment||Standard Error|Least Squares Mean
2671047|NCT01480076|Secondary|Change From Baseline in Percent Overall Work Impairment Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of overall work impairment||Standard Error|Least Squares Mean
2671048|NCT01480076|Secondary|Change From Baseline in Percent Impairment While Working Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of impairment while working||Standard Error|Least Squares Mean
2671049|NCT01480076|Secondary|Change From Baseline in Percent Work Time Missed Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of work time missed||Standard Error|Least Squares Mean
2671050|NCT01480076|Secondary|Change From Baseline in the Index Scores of EQ-5D at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|EQ-5D is a participant-answered questionnaire containing a descriptive system on 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The scores on the 5 dimensions of descriptive system can be converted into an index score by applying UK weights. EQ-5D index score ranges from 1 to -0.59, and 1 reflects the best outcome. An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671126|NCT01479595|Secondary|Morning and Evening Peak Expiratory Flow (PEF) Rate|Morning and evening PEFs were recorded on an electronic diary (e-diary). PEF was assessed twice daily approximately 12 hours apart and the measurements were recorded in the e-diary.|Baseline and 12 weeks|No analysis was performed on the collected data with the eDiary device due to overall poor data quality (values were obtained that were not physiologically possible) and high variability. Therefore, there is no data to present for this outcome measure.||||||
2671051|NCT01480076|Secondary|Change From Baseline in the Current Health State of EQ-5D VAS at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|EQ-5D is a participant-answered questionnaire containing a descriptive system of 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The EQ-5D VAS ranges from 0 (worst health state) to 100 (best health state). An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671052|NCT01480076|Secondary|Change From Baseline in the Activities Limitation Scale of the PRIMUS at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The PRIMUS activity measure is a 15-item assessment of patient-reported activities of daily living. The total score was calculated as sum of all 15 items converted into a 0-30 range, where missing items were imputed by average of non-missing total when no more than 50% of items were missing (otherwise, the total score is missing). Higher score indicates worse condition. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671053|NCT01480076|Secondary|Change From Baseline in MSIS-29 Psychological Score at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The MSIS-29 is a disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Sum of 9 psychological condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671054|NCT01480076|Secondary|Change From Baseline in the MSIS-29 Physical Score at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The MSIS-29 is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Sum of 20 physical condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671055|NCT01480076|Secondary|Change From Baseline in the MCS of the SF-36 at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671056|NCT01480076|Secondary|Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12 by Whether Taking Additional MS Therapy|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671242|NCT01478620|Secondary|Severity of uUTI Symptoms on Day 7||Day 7|||||||
2671057|NCT01480076|Secondary|Change From Baseline in Regular Activity Productivity Loss on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of activity impairment||Standard Error|Least Squares Mean
2671058|NCT01480076|Secondary|Change From Baseline in Percent Overall Work Impairment Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of overall work impairment||Standard Error|Least Squares Mean
2671059|NCT01480076|Secondary|Change From Baseline in Percent Impairment While Working Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of impairment while working||Standard Error|Least Squares Mean
2671060|NCT01480076|Secondary|Change From Baseline in Percent Work Time Missed Due to MS on the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12 by MS Disease Type: Responders|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of work time missed||Standard Error|Least Squares Mean
2671061|NCT01480076|Secondary|Change From Baseline in EQ-5D Index Scores at Months 3, 6, 9, and 12 by MS Disease Type: Responders|EQ-5D is a participant-answered questionnaire containing a descriptive system on 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The scores on the 5 dimensions of descriptive system can be converted into an index score by applying UK weights. EQ-5D index score ranges from 1 to -0.59, and 1 reflects the best outcome. An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671142|NCT01479478|Secondary|Count of Neonates With Meningitis||Up to 14 days following delivery|Participants with available data were included in the analysis.|||Participants|||Count of Participants
2671143|NCT01479478|Secondary|Count of Neonates With Pneumonia||Up to 14 days following delivery|Participants with available data were included in the analysis.|||Participants|||Count of Participants
2671243|NCT01478620|Secondary|Proportion of Patients With no Symptoms Worse Than Mild on Day 7 (i.e. Responders)||Day 7|||||||
2671062|NCT01480076|Secondary|Change From Baseline in Current Health State of the EQ-5D VAS at Months 3, 6, 9, and 12 by MS Disease Type: Responders|EQ-5D is a participant-answered questionnaire containing a descriptive system of 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The EQ-5D VAS ranges from 0 (worst health state) to 100 (best health state). An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671063|NCT01480076|Secondary|Change From Baseline in the Activity Limitation Scale (ALS) of PRIMUS Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The PRIMUS activity measure is a 15-item assessment of patient-reported activities of daily living. The total score was calculated as sum of all 15 items converted into a 0-30 range, where missing items were imputed by average of non-missing total when no more than 50% of items were missing (otherwise, the total score is missing). Higher score indicates worse condition. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671064|NCT01480076|Secondary|Change From Baseline in the MSIS-29 Psychological Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The MSIS-29 is a disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Sum of 9 psychological condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671065|NCT01480076|Secondary|Change From Baseline in the MSIS-29 Physical Score at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The MSIS-29 is a disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Sum of 20 physical condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671066|NCT01480076|Secondary|Change From Baseline in the MCS of the SF-36 at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671072|NCT01480076|Secondary|Change From Baseline in the Index Scores of EQ-5D at Months 3, 6, 9, and 12|EQ-5D is a participant-answered questionnaire containing a descriptive system on 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The scores on the 5 dimensions of descriptive system can be converted into an index score by applying United Kingdom (UK) weights. EQ-5D index score ranges from 1 to -0.59, and 1 reflects the best outcome. An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671067|NCT01480076|Secondary|Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12 by MS Disease Type: Responders|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, and 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671068|NCT01480076|Secondary|Change From Baseline in Regular Activity Productivity Loss, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of activity impairment||Standard Error|Least Squares Mean
2671069|NCT01480076|Secondary|Change From Baseline in Percent Overall Work Impairment Due to MS, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of overall work impairment||Standard Error|Least Squares Mean
2671070|NCT01480076|Secondary|Change From Baseline in Percent Impairment While Working Due to MS, by the WPAI-SHP Questionnaire at Months 3, 6, 9, and 12|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of impairment while working||Standard Error|Least Squares Mean
2671071|NCT01480076|Secondary|Change From Baseline in Percent Work Time Missed Due to MS, by the Work Productivity and Activity Impairment-Specific Health Problem (WPAI-SHP) Questionnaire at Months 3, 6, 9, and 12|WPAI-SHP is a 6-question participant-rated questionnaire to determine degree to which a specific health problem affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism (percentage of work time missed) and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 100 (completely affected/impaired). WPAI outcomes are expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||percentage of work time missed||Standard Error|Least Squares Mean
2671144|NCT01479478|Secondary|Count of Neonates With Sepsis||Up to 14 days following delivery|Participants with available data were included in the analysis.|||Participants|||Count of Participants
2671244|NCT01478620|Secondary|Incidence of Adverse Drug Reactions During the 7-day Treatment of uUTI Symptoms With Canephron® N in the Subgroup of Patients Who Take Canephron® N for at Least 7 Days||During active treatment period|||||||
2671073|NCT01480076|Secondary|Change From Baseline in the Current Health State of EuroQoL Descriptive System of Health-related Quality of Life States Consisting of 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Months 3, 6, 9, And 12|EQ-5D is a participant-answered questionnaire containing a descriptive system of 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a VAS on health state. The EQ-5D VAS ranges from 0 (worst health state) to 100 (best health state). An increase from baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671074|NCT01480076|Secondary|Change From Baseline in the Activities Limitation Scale of the Patient-Reported Indices for Multiple Sclerosis (PRIMUS) at Months 3, 6, 9, and 12|The PRIMUS activity measure is a 15-item assessment of patient-reported activities of daily living. The total score was calculated as sum of all 15 items converted into a 0-30 range, where missing items were imputed by average of non-missing total when no more than 50% of items were missing (otherwise, the total score is missing). Higher score indicates worse condition. A decrease from Baseline indicates improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671075|NCT01480076|Secondary|Change From Baseline in MSIS-29 Psychological Score at Months 3, 6, 9, and 12|The MSIS-29 is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Sum of 9 psychological condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less psychologically-related impact while a higher total score indicates greater psychologically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671076|NCT01480076|Secondary|Change From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Score at Months 3, 6, 9, and 12|The MSIS-29 is a disease specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Sum of 20 physical condition items converted into a 0-100 score range, where missing items are imputed by average of total of non-missing items when no more than 50% are missing (otherwise the total score is missing). A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a participant's functioning. Decreases from Baseline indicate improvement. A mixed effect model for repeated measures was used for this analysis. An unstructured covariance was used to model within-participant error. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671077|NCT01480076|Secondary|Change From Baseline in the MCS of the SF-36 At Months 3, 6, 9, and 12|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12).|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671090|NCT01479868|Secondary|Percentage of Participants With Viral Relapse|Participants were considered to have a viral relapse when, at actual end of treatment, HCV RNA levels were less than 25 IU per mL undetectable; and during the follow-up period, HCV RNA levels were more than or equal to 25 IU per mL.|Week 1 to 72|"The ITT population included all participants who received at least 1 dose of study drug. Here, N (number of participants analyzed) is the number of participants analyzed for this outcome measure."|||percentage of participants|||Number
2671091|NCT01479868|Secondary|Percentage of Participants With Viral Breakthrough|Confirmed increase of more than 1 log10 IU per mL in HCV RNA level from the lowest level reached, or a confirmed HCV RNA level of more than 100 IU per mL in participants whose HCV RNA levels had previously been below the limit of quantification (less than 25 IU per mL detectable) or undetectable (less than 25 IU per mL undetectable), while on study therapy.|Week 1 to 48|The ITT population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2671078|NCT01480076|Secondary|Change From Baseline in the PCS of the SF-36 at Months 3, 6, 9, and 12: Responders Versus Non-responders|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. The 'overall' estimate is the average change from baseline over the whole time period (through Month 12). In contrast to the primary endpoint, this analysis was done using data from both responder and non-responder groups; therefore, 'responder group' and 'visit by responder group interaction' were included as fixed effects.|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671079|NCT01480076|Primary|Change From Baseline in the Physical Component Scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) At Months 3, 6, 9, and 12: Responders|The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement. Within-group least squares means are presented.|Baseline, Months 3, 6, 9, 12|Participants in the intent-to-treat population (all participants who received at least 1 dose of study treatment and who provided at least 1 efficacy assessment at Baseline and the 3-month visit) who were included in the mixed effect model for repeated measures analysis.|||units on a scale||Standard Error|Least Squares Mean
2671080|NCT01479985|Secondary|Self-reported Continuation and Satisfaction Rate With Contraceptive Method||6 months||2019-06-30|06/2019||||
2671081|NCT01479985|Secondary|Self-reported Satisfaction With Decision Aid||6 months||2019-06-30|06/2019||||
2671082|NCT01479985|Secondary|Average Decisional Conflict Score|"The validated 10-item low-literacy Decisional Conflict Scale was used to measure decisional conflict pre- and post-intervention and compared the change in decisional conflict score in women randomized to the CDA to women undergoing routine counseling. A numeric score between 0 and 100 was calculated based on the responses with 0 indicating no decisional conflict and 100 indicating extremely high decisional conflict. Change in score was calculated by subtracting pre-intervention score from post-intervention score.~A negative mean score indicates a reduction in decisional conflict, indicating that the intervention helped reduce decisional conflict for the participant."|6 months||||units on a scale||Standard Deviation|Mean
2671083|NCT01479985|Primary|Percent of Women Using IUD, Implanon and Injectable Contraception|Percent of women using IUD, Implanon and injectable contraception compared to other less effective methods|6 months||||Participants|||Count of Participants
2671084|NCT01479868|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 126 that were absent before treatment or that worsened relative to pre-treatment state.|Week 1 to Week 72|Safety population included all participants who received at least 1 dose of study drug.|||participants|||Number
2671085|NCT01479868|Secondary|Change From Baseline in CD4+ Cell Count in Percentage||Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72|"Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here, n is the number of participants analyzed for this outcome measure at spcific time points."|||percentage of lymphocyte||Standard Deviation|Mean
2671086|NCT01479868|Secondary|Mean Change From Baseline in CD4+ Cell Count||Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72|"Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here, n is the number of participants analyzed for this outcome measure at spcific time points."|||cell counts per microliter||Standard Deviation|Mean
2671087|NCT01479868|Secondary|Mean Change From Baseline in Log10 Plasma Human Immunodeficiency Virus (HIV) Viral Load||Baseline (Day 1), Week 2, 4, 8, 12, 16, 20, 24, 28, 36, 42, 48, 52, 60 and 72|"Participants who received potent anti-HIV treatment with a combination of more than 3 antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed. Here n signifies participants evaluable for this measure at specified time point."|||copies per milliliter||Standard Deviation|Mean
2671088|NCT01479868|Secondary|Percentage of Human Immunodeficiency Virus (HIV) Participants With Virologic Failure|Participants had confirmed HIV virologic failure if HIV viral load values were greater than or equal to 50 or 200 copies/mL among those who previously had less than 50 copies/mL.|Baseline to Week 72.|Participants who received potent anti-HIV treatment with a combination of more than 3 anti-antiretroviral therapies to reduce HIV RNA viral load to undetectable levels were analyzed.|||percentage of participants|||Number
2671089|NCT01479868|Secondary|Percentage of Participants With Normalized Alanine Aminotransferase Levels|Participants with normalized alanine aminotransferase levels observed whose alanine aminotransferase levels were out of range at Baseline.|Baseline up to Week 72|"The ITT population included all participants who received at least 1 dose of study drug. Here N signifies participants evaluable for this measure."|||percentage of participants|||Number
2671093|NCT01479868|Secondary|Percentage of Participants With Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Less Than (<) 25 International Units (IU/mL) Undetectable or Detectable/Undetectable|Percentage of participants with HCV RNA less than (<) 25 IU/mL undetectable (undet.) or detectable (det.)/undetectable at specific time points were observed.|Week 4, 12, 24, 36, and 48|"ITT population included all participants who had at least 1 dose of study drug. Here, N (number of participants analyzed) is the number of participants analyzed for this outcome measure, n is the number of participants analyzed for this outcome measure at specific time points."|||percentage of participants|||Number
2671094|NCT01479868|Secondary|Percentage of Participants With Sustained Virologic Response at Week 24 (SVR 24)|The SVR 24 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable at 24 weeks after end of treatment.|24 weeks after end of treatment (Week 24 or 48)|The ITT population included all perticipants who had at least 1 dose of study drug.|||percentage of participants|||Number
2671095|NCT01479868|Primary|Percentage of Participants With Sustained Virologic Response at Week 12 (SVR 12)|The SVR 12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (<) 25 international unit per milliliter (IU/mL) undetectable at the actual end of treatment (EOT), and HCV RNA levels <25 IU/mL undetectable or HCV RNA levels <25 IU/mL detectable at 12 Weeks after end of treatment.|12 weeks after end of treatment (Week 24 or 48)|Intent to treat (ITT) population included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2671096|NCT01479777|Secondary|Change in Peak Cough Flow|Change in cough flow following 8 weeks of FES. Change in peak cough flow from baseline was computed from week 8 parameters.|Baseline, 8 weeks||||liters/minute||Full Range|Mean
2671097|NCT01479777|Secondary|Change in Vital Capacity|Change in vital capacity following 8 weeks of FES. Change in vital capacity from baseline was computed from week 8 parameters.|Baseline, 8 weeks||||litres||Full Range|Mean
2671098|NCT01479777|Secondary|Change in Rate of Perceived Exertion|"Change in rate of perceived exertion (RPE) following 8 weeks of FES. Change in rate of perceived exertion (RPE) from baseline was computed from week 8 parameters.~The RPE scale is a 15 point scale ranging from 6 to 20 points. Higher scores indicate greater exertion."|Baseline, 8 weeks||||scores on RPE scale||Full Range|Mean
2671099|NCT01479777|Secondary|Change in Diastolic Plood Pressure|Change in distolic blood pressure following 8 weeks. Change in diastolic blood pressure from baseline was computed from week 8 parameters.|Baseline, 8 weeks||||mmHg||Full Range|Mean
2671100|NCT01479777|Secondary|Change in Systolic Blood Pressure|Change in systolic blood pressure following 8 weeks. Change in systolic blood pressure from baseline was computed from week 8 parameters.|Baseline, 8 weeks||||mmHg||Full Range|Mean
2671101|NCT01479777|Secondary|Change in Heart Rate|Change in heart rate following 8 weeks of FES. Change in heart rate from baseline was computed from week 8 parameters.|Baseline, 8 weeks||||beats per minute||Full Range|Mean
2671102|NCT01479777|Primary|Change in Motor and Sensory Scores of the ASIA Impairment Scale (AIS)|"Change in motor, pin prick, and light touch score components of the ASIA Impairment scale (AIS) after 8 weeks of stepping FES in persons with spinal cord injury. The AIS evaluates motor and sensory function and comprises motor (min 0, max 100), pin prick (min 0, max 112), and light touch (min 0, max 112) scores. Higher scores represent better functional outcome.~AIS Classificatrion:~A = Complete: No motor or sensory function is preserved in the sacral segments S4-S5.~B = Incomplete: Sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5.~C = Incomplete: Motor function is preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3.~D = Incomplete: Motor function is preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade of 3 or more.~E = Normal: motor and sensory function are normal."|Baseline, 8 weeks||||scores on AIS Scale||Full Range|Mean
2671103|NCT01479764|Secondary|Time From Start of Study Drug Administration to Operating Room Discharge-ready|The time of operating room discharge readiness was determined by the surgical team based on clinical evaluations.|Day 1|The analysis population consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).|||minutes||95% Confidence Interval|Least Squares Mean
2671104|NCT01479764|Primary|Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry|Neuromuscular functioning was monitored by applying four TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.|At PACU entry on Day 1|The analysis population consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate) and had a reliable TOF measurement at PACU entry.|||participants|||Number
2671105|NCT01479725|Primary|Global Response Assessment (GRA)|The GRA measures overall improvement with therapy. The patient's response describes their current condition compared to before they received hyperbaric oxygen therapy (HBOT). Responses are: 1 Markedly Worse, 2 Moderately Worse, 3 Mildly Worse, 4 Unchanged, 5 Mildly Better, 6 Moderately Better and 7 Markedly Better.|3 months post treatment||||number of participants|||Number
2671106|NCT01479621|Other Pre-specified|Change From Baseline In Weekly Average Of Daily Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.~PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake.~The p-values for the treatment comparisons to placebo are from an MMRM model including all treatment groups: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)|Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns.|||liters/minute||Standard Error|Least Squares Mean
2671107|NCT01479621|Other Pre-specified|Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.~On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit.~Baseline trough AM PEF was defined as the average of recorded (non-missing) trough AM PEF assessments over the 7 days directly preceding first study drug intake.~The p-values for the treatment comparisons to placebo are from an MMRM model including all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)|Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns.|||liters/minute||Standard Error|Least Squares Mean
2671108|NCT01479621|Other Pre-specified|Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data|"Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation.~The p-values for the treatment comparisons to placebo are from an MMRM model including data from all treatments: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Day 1, pre-dose), During Study (Days 7, 14, 28, 56 and 84 pre-dose)|Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns.|||liters||Standard Error|Least Squares Mean
2671109|NCT01479621|Secondary|Oropharyngeal Exam Findings at Each Study Visit|"Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at all study visits. If the visual oropharyngeal examination was abnormal at the screening visit, the subject was excluded from entering the study and subjects with an abnormal oropharyngeal exam on Day 1 were not eligible for randomization. Any visual evidence of oral candidiasis during the treatment period of the study was evaluated by obtaining and analyzing a swab of the suspect area. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Subjects with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol. If a subject required a protocol-prohibited medication for therapy, the subject was to be discontinued from the study.~Data format: Time frame, <signs of oral candidiasis?> yes or no"|Screening (week -3 to -2), Baseline (Week 0), Weeks 1, 2, 4, 8, 12|Safety population|||Participants|||Count of Participants
2671110|NCT01479621|Secondary|Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period|An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 -84|Safety analysis set|||Participants|||Count of Participants
2671111|NCT01479621|Secondary|Time of Maximum Concentration (Tmax) of Fp|Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments.|Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose|Pharmacokinetics analysis set. Placebo samples not included in these results.|||hours||Standard Deviation|Mean
2671112|NCT01479621|Secondary|Maximum Observed Plasma Concentration (Cmax) of Fp|Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments.|Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose|Pharmacokinetics analysis set. Placebo samples not included in these results.|||pg/mL||Standard Deviation|Mean
2671113|NCT01479621|Secondary|Area Under The Curve From Time 0 Until The Last Measurable Concentration (AUC0-t) of Fp|Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments.|Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose|Pharmacokinetics analysis set. Placebo samples not included in these results.|||pg*hr/mL||Standard Deviation|Mean
2671114|NCT01479621|Secondary|Kaplan-Meier Estimate of Probability of Remaining in the Study at Week 12|The time to withdrawal due to stopping criteria was compared between the treatment groups with the log rank test. The Kaplan-Meier estimate of the probability of remaining in the study at week 12 with 95% CI was presented by treatment group. Subjects who completed the study were censored at the date of completion, subjects who withdrew for reasons other than stopping criteria were censored at the time of withdrawal. Stopping criteria were based on day subject first met stopping criteria, using subject's diary data and asthma exacerbations recorded in CRF.|Day 1 to Day 84|Full analysis set|||probability||95% Confidence Interval|Number
2671115|NCT01479621|Secondary|Change From Baseline in the Percentage of Rescue-Free 24-hour Periods During the 12-Week Treatment Period|"The number of inhalations of rescue medication used each day and each night was recorded in the subject's diary device.~Change from baseline in the percentage of rescue-free 24-hour periods was analyzed with a marginal (also called population averaged) logistic model. The model included 2 time points of measurement for each subject: the baseline and the treatment period. The model contained covariates for sex, age, and treatment. The model for the 2 time points was considered as an incomplete randomized block model, with each subject as a block, receiving the baseline level in 1 sub-block and either active treatment or placebo in the other sub-block. The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject.~Measure type are estimated mean and measure of dispersion is the standard error of the estimated mean."|Baseline (Days -7 to -1), During Study (Days 1-84)|Full analysis set|||percentage of total 24 hour periods||Standard Error|Mean
2671116|NCT01479621|Secondary|Change From Baseline In Weekly Average Of Daily Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.~PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake.~The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)|Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints (see outcome #13).|||liters/minute||Standard Error|Least Squares Mean
2671117|NCT01479621|Secondary|Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period|"Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device.~On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit.~Baseline trough AM PEF was defined as the average of recorded (non-missing) trough AM PEF assessments over the 7 days directly preceding first study drug intake.~The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)|Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints (see outcome #12).|||liters/minute||Standard Error|Least Squares Mean
2671118|NCT01479621|Primary|Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period|"Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation.~The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed."|Baseline (Day 1, pre-dose), During Study (Days 7, 14, 28, 56 and 84 pre-dose)|Full analysis set, (participants who contributed >=1 to the analysis). Data from one site omitted due to GCP concerns. Flovent Diskus data was used for confirmatory and exploratory endpoints (see outcome #11).|||liters||Standard Error|Least Squares Mean
2671119|NCT01479595|Secondary|Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)|FeNO was assessed as a measure of airway inflammation. An FeNO machine was used to obtain the FeNO measurements. FeNO measurements were obtained prior to the spirometry assessments.|baseline, 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.|||parts per billion (ppb)||Standard Error|Least Squares Mean
2671120|NCT01479595|Secondary|Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the VAK694 Analyte|Blood samples were obtained to measure Cmin,ss.|days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.|||ug/mL||Standard Deviation|Mean
2671121|NCT01479595|Secondary|Lowest Plasma Concentration Observed During a Dosing Interval at Steady State (Cmin,ss) of the QAX576 Analyte|Blood samples were obtained to measure Cmin,ss.|days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.|||ng/mL||Standard Deviation|Mean
2671122|NCT01479595|Secondary|Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the VAK694 Analyte|Blood samples were obtained to measure Cmax,ss.|days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.|||ug/mL||Standard Deviation|Mean
2671123|NCT01479595|Secondary|Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) of the QAX576 Analyte|Blood samples were obtained to measure Cmax,ss.|days 1 (pre-dose and 2 hours post-dose), 15, 29 (pre-dose and 2 hours post-dose), 43, 57 (pre-dose and 2 hours post-dose), 71, 85 (pre-dose and 2 hours post-dose), 99, 113, 141, 183|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had week 12 values were included in the analysis.|||ng/mL||Standard Deviation|Mean
2671127|NCT01479595|Secondary|Change in Asthma Quality of Life Questionnaire (AQLQ) Score|"The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. It consists of 4 domains: symptoms, emotions., exposure to environmental stimuli and activity limitation.~Patients were asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale. The scale ranges from 1 to 7. The overall AQLQ score was the mean response to all 32 questions. Higher scores represent better outcomes."|Baseline and 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
2671128|NCT01479595|Secondary|Change in Forced Expiratory Volume in One Second (FEV1)|FEV1 was assessed using central spirometry according to the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines.|Baseline and 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2671129|NCT01479595|Primary|Change From Baseline in Asthma Control Questionnaire (ACQ) Score|The ACQ consists of 7 questions assessing symptoms, rescue medication use and lung function. Except for lung function (FEV1), each question was scored on a 7-point scale where 0 = no impairment and 6 = maximum impairment. Scores ranged between 0 totally controlled to 6 (severely uncontrolled). Participants with a score below 1.0 are considered to have adequately controlled asthma. Participants with a score above 1.0 were considered not to be well controlled. A negative change from baseline indicates improvement.|Baseline and 12 weeks|Participants from the per-protocol analysis set were considered for the analysis. Only participants who had both baseline and week 12 values were included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
2671130|NCT01479543|Secondary|Gastrointestinal and Immune Effects of Probiotics Consumption.|"Effect on the systemic and adaptive immune system. This will be measured by means of lymphocite populations and plasma cytokine present on blood, IgAs on serum (at zero time and after four weeks of treatment), IgAs on saliva and faeces and AGCC (at zero time and after four weeks and two more weeks).~Gastrointestinal effects will be measured by means of gastrointestinal symptoms record and frequency and aspect of faeces, during the treatment and the following two weeks (wash-out period)."|At Time zero, after 4 weeks, and 2 later.|||||||
2671131|NCT01479543|Primary|Gastrointestinal Tolerance After Probiotic Consumption.|"Tolerance of these probiotic strains was determined using the gastrointestinal symptom rating scale (GSRS), daily recorded gastrointestinal symptoms and defecation frequency.Intolerance was defined as a symptom score of 2 or higher on the GSRS. The unit of measure is the number of participants was tolerant to the intervention."|4 weeks of the treatments. Daily recorded.|Calculation of simple size was based on the variance in the probiotic strain count (log strain CFU/g) in feces and a difference of 25% compared with the placebo. alfa: 0.05 power 90%|||participants|||Number
2671132|NCT01479530|Secondary|Change From Baseline in UPDRS Motor Score During ON Time|UPDRS is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worse outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: ADL - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).|Baseline and Week 16|FAS; LOCF|||units on a scale||Standard Error|Mean
2671133|NCT01479530|Secondary|Change From Baseline in UPDRS-ADL Score During OFF Time|Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's Disease-related disability and impairment using a patient interview and a physical examination. It has 4 parts and 4 subsection scores. A higher score indicates a worse outcome. I: mentation, behaviour and mood symptoms - 0 to 16; II: activities of daily living (ADL) - 0 to 52; III: motor function - 0 to 108; IV: complications of dopaminergic therapy - 0 to 23. Subsection scores for I to III are used to calculate a total score that ranges from 0 (no disability) to 176 (total dependence).|Baseline and Week 16|FAS; LOCF|||units on a scale||Standard Error|Mean
2671134|NCT01479530|Secondary|Clinical Status Using CGI-I Score During ON Time|Clinical Global Impression - Global Improvement (CGI-I) is a single-item rating scale used to evaluate a patient's condition relative to baseline on a 7-point scale, regardless of whether the improvement is related to the investigational medicinal product (IMP). The scale ranges from 1 (very much improved) to 7 (very much worse).|Week 16|FAS; last observation carried forward (LOCF)|||units on a scale||Standard Error|Mean
2671135|NCT01479530|Primary|Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary|"Parkinson's Disease Patient Diary is a self-administered diary designed to assess motor fluctuations throughout the day. It is divided into 30-minute intervals, and the patient selects one of four options for each interval: asleep; off; on with no dyskinesia or without troublesome dyskinesia; or on with troublesome dyskinesia.~The Change From Baseline in Mean Total Daily OFF time is calculated by taking the difference between the average of the total daily OFF time at Weeks 4, 8, 12, and 16, and the Baseline Total Daily OFF Time."|Baseline and Weeks 4, 8, 12, and 16|Full-analysis set (FAS); observed cases (OC)|||hours||Standard Error|Mean
2671136|NCT01479517|Secondary|Naris Examination|Number of patients with an abnormal naris examination finding.|60 minutes post drug administration||||Participants|||Count of Participants
2671137|NCT01479517|Secondary|The Proportion of Subjects Giving a Positive Response to Evaluation Question for Subjective Numbness Assessment (SNA) After the Procedure is Completed.||60 minutes||||participants|||Number
2671138|NCT01479517|Secondary|The Incidence of Subjects Receiving Kovacaine Mist With Changes in Systolic and Diastolic Blood Pressure Exceeding +/- 25% of Preoperative Measurements Values.||60 minutes||||participants|||Number
2671139|NCT01479517|Primary|The Proportion of Subjects Receiving Kovacaine Mist Who do Not Require Rescue Anesthesia During the Operative Dental Procedure||at 15 minutes, with +10 minute window||||participants|||Number
2671140|NCT01479478|Secondary|Length of Neonatal Hospital Stay||Up to 14 days following delivery|Participants with available data were included in the analysis.|||days||Inter-Quartile Range|Median
2671141|NCT01479478|Secondary|Count of Neonates With Intensive-care Unit Admission||Up to 14 days following delivery|Participants with available data were included in the analysis.|||Participants|||Count of Participants
2671148|NCT01479478|Secondary|Apgar Score at 1 and 5 Minutes Following Delivery|Apgar score is a measure to quickly assess the neonatal health status from time of delivery. Score ranges from 0-10. Lower scores correspond to worse health state; neonates with scores below 5 are considered to have poor prognosis.|At time of delivery (up to 42 weeks of gestation)|Participants with available data were included in the analysis.|||units on a scale||Inter-Quartile Range|Median
2671149|NCT01479478|Secondary|Gestational Age at Delivery|Gestational age at delivery is presented as weeks.|At time of delivery (up to 42 weeks of gestation)|Participants with available data were included in the analysis.|||weeks||Inter-Quartile Range|Median
2671150|NCT01479478|Secondary|Count of Participants With Other Infectious Morbidity|Other infectious morbidity included maternal mastitis or pneumonia.|From time of labor onset up to 6 weeks postpartum|Participants with available data were included in the analysis.|||Participants|||Count of Participants
2671151|NCT01479478|Secondary|Count of Participants With Sepsis|Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated response of the body to an infection.|From labor onset up to 6 weeks postpartum|Participants with available data were included in the analysis.|||Participants|||Count of Participants
2671152|NCT01479478|Secondary|Count of Participants With Bacteremia|Bacteremia is defined as presence of bacteria in the blood.|From time of labor onset up to 6 weeks postpartum|Participants with available data were included in the analysis.|||Participants|||Count of Participants
2671153|NCT01479478|Secondary|Count of Participants With Cellulitis|Cellulitis is a bacterial skin infection.|From time of delivery up to 6 weeks postpartum|Participants with available data were included in the analysis.|||Participants|||Count of Participants
2671154|NCT01479478|Secondary|Count of Participants With Endometritis|Endometritis is a uterine (myometrial) infection.|From time of delivery up to 6 weeks postpartum|Participants with available data were included in the analysis.|||Participants|||Count of Participants
2671155|NCT01479478|Secondary|Count of Participants With Intrapartum Chorioamnionitis|Intrapartum chorioamnionitis is maternal temperature above 38.0 degrees Celsius and one or more of the following findings: fetal tachycardia; maternal tachycardia; uterine tenderness; purulent or malodorous amniotic fluid, or elevated maternal white blood cell count.|From time of labor onset until delivery (up to 42 weeks of gestation)|Participants with available data were included in the analysis.|||Participants|||Count of Participants
2671156|NCT01479478|Secondary|Count of Participants With Urinary Tract Infection||From enrollment up to delivery hospitalization (up to 42 weeks gestation)|Participants with available data were included in the analysis.|||Participants|||Count of Participants
2671157|NCT01479478|Primary|Count of Participants With Positive Group B Streptococcus Rectovaginal Colonization Status at 35- 37 Weeks' Gestational Age|Gestational age is given in a format of full weeks.|35 to 37 weeks gestational age|Participants with available data were included in the analysis|||Participants|||Count of Participants
2671158|NCT01479465|Secondary|Objective Response Rate (ORR)|Objective response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD). The ORR was defined as the percentage of participants who achieved a CR or PR.|Randomization up to 27 months|Participants in the Full Analysis Set were analyzed.|||percentage of participants||95% Confidence Interval|Number
2671159|NCT01479465|Secondary|Overall Survival (OS)|The OS is measured as time from date of randomization to death regardless of cause. The OS was analyzed using KM estimates.|Randomization up to 33 months|Participants in the Full Analysis Set were analyzed.|||months||95% Confidence Interval|Median
2671160|NCT01479465|Primary|Progression Free Survival (PFS)|The PFS was defined as the time from the date of randomization to the earliest event time of: a) death regardless of cause, or b) first indication of disease progression. PFS was analyzed using Kaplan-Meier (KM) estimates.|Randomization up to 27 months|Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.|||months||95% Confidence Interval|Median
2671161|NCT01479426|Secondary|Changes in IIEF(International Index of Erectile Function)-Total Domain|"IIEF(International Index of Erectile Function)-total domain(score range: 5-75) was measured in study visit 1(0 week) and visit 3(12 week).~IIEF includes 15 questions and addresses the 5 sub-domains of Erectile function, Intercourse satisfaction, Orgasm function, Sexual desire, and Overall satisfaction.~The IIEF-total domain is the sum of sub-domains. Lower scores indicate severe erectile dysfunction, while higher scores indicate less erectile dysfunction."|12 weeks|per protocol analysis|||Scores on a scale||Standard Deviation|Mean
2671162|NCT01479426|Secondary|Changes in Uroflowmetry(Max Flow Rate)|uroflowmetry(max flow rate) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||m/sec||Standard Deviation|Mean
2671163|NCT01479426|Secondary|GEAQ (Global Efficacy Assessment Question)||after 12weeks of consumption|||||||
2671164|NCT01479426|Secondary|Changes in MSHQ (Male Sexual Health Questionnaire)|"MSHQ(Male Sexual Health Questionnaire) was measured in study visit 1(0 week) and visit 3(12 week).~The total MSHQ score (25 questions) ranges from 17-130, with higher scores indicating greater sexual function."|12 weeks|per protocol analysis|||Scores on a scale||Standard Deviation|Mean
2671165|NCT01479426|Primary|Changes in EF(Erectile Function) Domain|"EF(erectile function, score 0-20) domain was measured in study visit 1(0 week) and visit 3(12 week).~The original index consists of 4 Questions. Individual question response is assigned a score of between 0 (worst) to 5 (best) and summed to form a score ranging from 0 (worst) to 20 (best)."|12 weeks|per protocol analysis|||Scores on a scale||Standard Deviation|Mean
2671166|NCT01479374|Secondary|Mean Conjunctival Redness at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.|||Units on a scale||Standard Deviation|Mean
2671167|NCT01479374|Secondary|Mean Ocular Itching at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.|3, 5, and 7 minute timepoints, post-CAC on Day 1 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.|||Units on a scale||Standard Deviation|Mean
2671168|NCT01479374|Secondary|Mean Total Redness at 24 Hours Duration of Action|A treatment efficacy CAC was performed 24 hours after drop instillation. Total redness (0-12) is defined as the sum of ciliary redness (0-4 scale, from 0=none to 4=extremely severe), conjunctival redness (0-4 scale, from 0=none to 4=extremely severe), and episcleral redness (0-4 scale, from 0=none to 4=extremely severe). Average of total redness score over both eyes was analyzed.|7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.|||Units on a scale||Standard Deviation|Mean
2671169|NCT01479374|Secondary|Mean Conjunctival Redness at 16 Hours Duration of Action|A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, and 20 minute timepoints, post-CAC on Day 14 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.|||Units on a scale||Standard Deviation|Mean
2671170|NCT01479374|Secondary|Mean Conjunctival Redness at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, and 20 minute timepoints, post-CAC on Day 21 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.|||Units on a scale||Standard Deviation|Mean
2671171|NCT01479374|Primary|Mean Ocular Itching at 16 Hours Duration of Action|A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.|3, 5, and 7 minute timepoints, post-CAC on Day 14 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.|||Units on a scale||Standard Deviation|Mean
2671172|NCT01479374|Primary|Mean Ocular Itching at Onset of Action|A treatment efficacy CAC was performed 27 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.|3, 5, and 7 minute timepoints, post-CAC on Day 21 of receiving treatment|Intent to treat (ITT). The analysis population included all randomized patients who received treatment and had post CAC data.|||Units on a scale||Standard Deviation|Mean
2671173|NCT01479270|Secondary|Intraoperative Time|The total time in the operating room will be recorded to see if there is a difference between groups.|the total intraoperative time in minutes||||Minutes||95% Confidence Interval|Median
2671174|NCT01479270|Secondary|Visual Analog Scale (VAS) for Pain|visual analogue scales for pain will be completed on post-operative day #0 and #1, pain is assessed on a 10-point visual analogue scale (0 = no pain; 1 to 3 = mild; 4 to 6 = moderate pain; 7 to 10 = severe pain.)|2 and 24 hours post operative||||units on a scale||Full Range|Median
2671175|NCT01479270|Secondary|Narcotic Use|narcotic use in mg of Morphine will be recorded|Postop Day #0 and Day #1||||mg of morphine||Full Range|Median
2671176|NCT01479270|Primary|Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2|40 question survey completed on paper or by telephone on post-operative day #1 or #2, designed to measure health status after surgery and anesthesia. Scale ranges from 40 (extremely poor qualify of recovery) to 200 (excellent quality of recovery).|Postop Day #1 or Day #2||||units on a scale||Full Range|Median
2671177|NCT01479127|Secondary|Number of Participants With Product Quality Complaints (PQC) During the ABT-SLV187 Treatment Period||Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.|||participants|||Number
2671178|NCT01479127|Secondary|Ratio of Metabolite 3-OMD to Levodopa (M/P [AUC0-12]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|M/P (AUC0-12) after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.|||ratio||Standard Deviation|Mean
2671179|NCT01479127|Secondary|Degree of Fluctuation (2-12 Hours) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|Degree of Fluctuation (calculated as [Cmax - Cmin] / Cavg)) of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.|||ratio||Standard Deviation|Mean
2671180|NCT01479127|Secondary|AUC0-12/Dose0-12, AUC0-16/Dose0-16 After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|AUC0-12/Dose0-12 of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21). AUC0-16/Dose0-16 of levodopa, carbidopa, and 3-OMD after administration of intra-jejunal administration of ABT-SLV187 (Day 21).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.|||µg*h/mL/mg||Standard Deviation|Mean
2671181|NCT01479127|Secondary|The Area Under the Concentrations-time Curve From 0 to 12 and 0 to 16 Hours (AUC0-12, AUC0-16) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|AUC0-12 and AUC0-16 of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.|||µg*h/mL||Standard Deviation|Mean
2671245|NCT01478620|Primary|Incidence of Adverse Drug Reactions During 7-day Treatment of uUTI Symptoms With Canephron® N|No study drug related adverse drug reactions were registered.|During active treatment period (day 1 until day 7)||||Adverse Drug Reactions|||Number
2671277|NCT01478581|Primary|The Clinical Benefit Response (CBR)|The clinical benefit response (CBR) rate, defined as the proportion of subjects who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) as assessed by the modified International Myeloma Working Group (IMWG) response criteria|From the date of first study treatment until disease progression per IMWG, up to 60 months|All treated population|||Participants|||Count of Participants
2671182|NCT01479127|Secondary|Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), Trough Plasma Concentration (Cmin), and Cmin Within 2 and 12 Hours (Cmin [2-12 Hours]) After Administration of Oral L/C Tablets and Intra-jejunal Administration of ABT-SLV187|Cmax, Cavg, Cmin, and Cmin (2-12 hours) of levodopa, carbidopa, and 3-OMD after administration of the oral L/C tablets (Day -1) and intra-jejunal administration of ABT-SLV187 (Day 21). Cmin values for levodopa and carbidopa during the 16 hours of infusion were observed either at time 0 or 15 min after start of the infusion and were a result of drug washout prior to establishment of infusion.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|PK sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.|||µg/mL||Standard Deviation|Mean
2671183|NCT01479127|Secondary|Time to Reach Peak Plasma Concentration (Tmax) After Administration of Oral Levodopa/Carbidopa (L/C) Tablets and Intra-jejunal Administration of ABT-SLV187|Tmax of levodopa, carbidopa, and its metabolite 3-O-methyldopa (3-OMD) after administration of oral L/C tablets and intra-jejunal administration of ABT-SLV187.|Baseline (Day -1): pre-dose; 15, 30, 45, 60 mins post-morning dose; every 30 mins thereafter for 12 hrs. Day 21: pre-dose; 15, 30, 45, 60 mins post-infusion; every 30 mins from hrs 1 to 12 post-infusion; every 2 hrs from 12 to 16 hrs post-infusion.|Pharmacokinetic (PK) sample: participants who completed PK assessments in both the oral L/C and ABT-SLV187 Treatment Periods.|||hours||Standard Deviation|Mean
2671184|NCT01479127|Primary|"Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the Normal State on the Treatment Response Scale (TRS) I"|"Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks: rest, finger taps, rapid alternating movement of hands, arising from chair and gait, including confirmation of postural stability. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the following Video Assessment and Treatment Response Scale (TRS) under blinded conditions: Finger Taps, Rapid Alternating Movement of Hands, Arising from Chair, Gait, Body Bradykinesia and Hypokinesia, Dyskinesia. The average of the neurologists' evaluations was calculated as a percentage of ratings in the Normal state (ie, mild OFF to ON with mild dyskinesia) on the TRS I (total 10 assessments per day)."|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.|||percentage of ratings||Standard Deviation|Mean
2671185|NCT01479127|Primary|Number of Participants With Potentially Clinically Significant 12-lead Electrocardiogram (ECG) Results During the ABT-SLV187 Treatment Period|High potentially clinically significant Bazett's heart rate-corrected QT interval (QTcB) values were: 450 msec for males / 470 msec for females.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.|||participants|||Number
2671186|NCT01479127|Primary|Number of Participants With Potentially Clinically Significant (PCS) Vital Signs Results During the ABT-SLV187 Treatment Period|↓=decrease, ↑=increase, BL=baseline, temp.=temperature, SBP=systolic blood pressure, Sup.=supine, Sta.=standing, DBP=diastolic blood pressure.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.|||participants|||Number
2671187|NCT01479127|Primary|Number of Participants With Potentially Clinically Significant Urinalysis Results During the ABT-SLV187 Treatment Period||Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.|||participants|||Number
2671188|NCT01479127|Secondary|Clinical Global Impression - Severity (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Baseline and End of Treatment|The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: normal, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, and among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.|||participants|||Number
2671189|NCT01479127|Secondary|Schwab and England Activities of Daily Living Scale at Baseline and End of Treatment|The Schwab and England scale was used to rate the subject's activities of daily living by recording the percentage score, ranging between being completely independent (100%) and totally dependent (10%).|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.|||units on a scale||Full Range|Median
2671190|NCT01479127|Secondary|Modified Hoehn and Yahr Staging at Baseline and End of Treatment|Participant's ON and OFF states staged according to the Modified Hoehn and Yahr criteria, an 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. ON time is when PD symptoms are well controlled by the drug. OFF time is when PD symptoms are not adequately controlled by the drug.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.|||units on a scale||Full Range|Median
2671191|NCT01479127|Secondary|Change From Baseline to the End of Treatment in the Japanese Version of Parkinson's Disease Questionnaire 39 (PDQ-39) Total Score and Domain Scores|The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients, including Mobility, Activities of Daily Living, Emotional Well-being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort, as well as a Summary Index Total Score. Scores for each are on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
2671316|NCT01477892|Secondary|Adverse Reaction|bradycardia, hypotension, apnea, desaturation|during and after 10min of remifentanil continous infusion||||participants|||Number
2671192|NCT01479127|Secondary|Mean Change From Baseline to the End of Treatment in UPDRS Total Scores and Subscores|The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score ranges from 0-176, with 176 representing the worst (total) disability, and 0 no disability. The Part I Score is the sum of the answers to the 4 questions related to Mentation, Behavior and Mood, and ranges from 0-16. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. The Part III score is the sum of the 27 answers related to Motor Examination, and ranges from 0-108. The Part IV Score is the sum of the answers to the 11 questions related to Complications of Therapy, and ranges from 0-23. The Part IV dyskinesia subscore ranges from 0-12. For each part of the UPDRS, higher scores are associated with more disability.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
2671193|NCT01479127|Secondary|Baseline and Endpoint (End of Treatment) Video Scoring of Unified Parkinson's Disease Rating Scale (UPDRS) Items and Dyskinesia|Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the video under blinded conditions using the following assessments: Tremor at Rest (UPDRS item #20), Finger Taps (UPDRS #23), Rapid Alternating Movement of Hands (UPDRS #25), Arising from Chair (UPDRS #27), Gait (UPDRS #29), Postural Stability (UPDRS #30), Body Bradykinesia and Hypokinesia (UPDRS #31), and Dyskinesia (evaluated with the Goetz Dyskinesia Rating Scale). The UPDRS score is the sum of the answers to individual questions, each of which are measured on a 5-point scale (0-4), with higher scores associated with more disability. The Goetz Dyskinesia Rating Scale is a 5-point scale of the severity of dyskinesias, from 0 (absent) to 4 (violent dyskinesias).|Baseline (Day -1), Endpoint (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.|||units on a scale||Standard Deviation|Mean
2671194|NCT01479127|Secondary|Change From Baseline to the End of Treatment in Parkinson's Disease Diary Assessment|For each half hour period during 3 consecutive days prior to each assessment of the diary, participants (and/or their caregivers) entered into a diary whether they were asleep, in the ON motor state or in the OFF motor state in the following 5 grades: asleep, OFF, ON (no dyskinesia [D]), ON with non-troublesome dyskinesia (NTD), ON with troublesome dyskinesia (TD). ON time is when PD symptoms are well controlled by the drug. OFF time is when PD symptoms are not adequately controlled by the drug. Dyskinetic time is time with involuntary muscle movement. The ON or OFF times were calculated as the average of 3 daily times from the diaries. w/o = without, w/ = with|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.|||hours||Standard Deviation|Mean
2671195|NCT01479127|Secondary|"Mean Change From Baseline to the End of Treatment in Percentage of Ratings in the OFF and Dyskinesia States on the TRS I and the Normal, OFF, and Dyskinesia States on the TRS II"|"Participants were video recorded a total of 10 times for 1 to 2 minutes every 60 minutes while performing a standardized sequence of motor tasks: rest, finger taps, rapid alternating movement of hands, arising from chair and gait, including confirmation of postural stability. Based on these video recordings, a Video Evaluation Committee consisting of 3 neurologists individually evaluated the following Video Assessment and TRS under blinded conditions: Finger Taps, Rapid Alternating Movement of Hands, Arising from Chair, Gait, Body Bradykinesia and Hypokinesia, Dyskinesia for TRS I, with the addition of Tremor at Rest and Postural Stability for TRS II. The average of the 3 neurologists' evaluations was calculated as a percentage of ratings in the Normal state (ie, mild OFF to ON with mild dyskinesia), the Off state (moderate OFF to severe OFF), and the Dyskinesia state (ON with moderate dyskinesia to ON with severe dyskinesia) on the TRS I or II."|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|Full Analysis Set: participants who had data for baseline and at least one post-baseline efficacy measurement.|||percentage of ratings||Standard Deviation|Mean
2671196|NCT01479127|Primary|Number of Participants With PCS Values in Special Laboratory Parameters During the ABT-SLV187 Treatment Period|M=male, F=female|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.|||participants|||Number
2671197|NCT01479127|Primary|Number of Participants With PCS Blood Biochemistry Results During the ABT-SLV187 Treatment Period|M=male, F=female, γ-GTP=gamma-glutamyl transpeptidase.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.|||participants|||Number
2671198|NCT01479127|Primary|Number of Participants With Potentially Clinically Significant (PCS) Hematology Results During the ABT-SLV187 Treatment Period|M=male, F=female, MCV=mean corpuscular volume, MCH=mean corpuscular hemoglobin, MCHC=mean corpuscular hemoglobin concentration.|Baseline (Day -1), End of ABT-SLV187 Treatment Period (Day 21)|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.|||participants|||Number
2671199|NCT01479127|Primary|Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation During the ABT-SLV187 Treatment Period|AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. SAE: an event that results in the death of a subject, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, or other important medical event. Severity was rated as mild, moderate, or severe. AEs of special interest included: device-associated gastrointestinal disorders; cardiovascular fatalities; aspiration including aspiration pneumonia; a diagnosis of peripheral polyneuropathy (axonal, demyelinating or mixed type); possible symptoms of peripheral polyneuropathy; clinically significant weight loss. 'AEs at least possibly related' are defined as those that were assessed by investigator as probably related or possibly related.|From NJ placement to end of ABT-SLV187 Treatment Period (Day 21) +30 days|ABT-SLV187 safety sample: participants who had at least one dose of the ABT-SLV187 study medication after the baseline assessment.|||participants|||Number
2671468|NCT01475955|Secondary|AK Clearance Rate|"AK Clearance Rate (AKCR) for a subject is defined as:~100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]"|Baseline, Week 4||||percent clearance||Standard Deviation|Median
2671200|NCT01479127|Primary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation During the Run-in Period|AE: any untoward medical occurrence in a participant that does not necessarily have a causal relationship with this treatment. SAE: an event that results in the death of a subject, is life threatening, results in hospitalization or prolongation of hospitalization, is a congenital anomaly, results in persistent or significant disability/incapacity, or other important medical event. Severity was rated as mild, moderate, or severe. AEs of special interest included: device-associated gastrointestinal disorders; cardiovascular fatalities; aspiration including aspiration pneumonia; a diagnosis of peripheral polyneuropathy (axonal, demyelinating or mixed type); possible symptoms of peripheral polyneuropathy; clinically significant weight loss. 'AEs at least possibly related' are defined as those that were assessed by investigator as probably related or possibly related.|During the Run-in period (up to approximately 28 days)|Full safety sample: participants who had at least one dose of oral levodopa-carbidopa study drug in the Run-in Period.|||participants|||Number
2671201|NCT01479010|Secondary|Oxygen Uptake Efficiency Slope||28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.||||||
2671202|NCT01479010|Secondary|Total Exercise Time||28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.||||||
2671203|NCT01479010|Secondary|Rate of Adverse Events and Hospitalizations||28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.||||||
2671204|NCT01479010|Secondary|Correlation Between Interval Changes in Biomarkers, Peak VO2, and VE/VCO2||28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.||||||
2671205|NCT01479010|Secondary|Interval Change From Baseline in Heart Failure Symptoms as Measured by Duke Activity Status Index (DASI)||28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.||||||
2671206|NCT01479010|Secondary|Interval Change From Baseline in Biomarkers (High-sensitivity C-reactive Protein, Whole Blood Assay, Brain Natriuretic Peptide)||28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.||||||
2671207|NCT01479010|Primary|Median Interval Change From Baseline in the Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)|VE/VCO2 slope will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask.|28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.||||||
2671208|NCT01479010|Primary|Median Interval Change From Baseline in Peak VO2|Peak VO2 will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask.|28 days|Due to the small number of participants, results are not included to protect the privacy of individual participants.||||||
2671209|NCT01478971|Secondary|Percentage of Participants Who Received a Whole Blood or Red Blood Cell Transfusion||12 months|Safety population|||percentage of participants|||Number
2671210|NCT01478971|Secondary|Percentage of Participants Who Received at Least One Intravenous Iron Dose|Participants received iron supplementation during the study to prevent iron deficiency and to maintain iron stores.|12 months|Safety population|||percentage of participants|||Number
2671211|NCT01478971|Secondary|Percentage of Participants With Hemoglobin Levels Greater Than 10 and Less Than or Equal to 11 g/dL|Percentage of participants with hemoglobin values within the hemoglobin range of 10-11 g/dL.|Months 1, 2, 3, 4, 5 and 6 of each treatment period|Full Analysis Population included all enrolled participants who received at least 1 dose of study treatment during the Peginesatide Treatment Period. n indicates the number of participants with available data at each time point.|||percentage of participants|||Number
2671212|NCT01478971|Secondary|Peginesatide Dose Deviations|Data collected by sponsor of study (Affymax), and sponsor did not provide aggregate summary data.|Months 6 - 12|||||||
2671213|NCT01478971|Secondary|Peginesatide Dosing|The starting dose, mean dose throughout the study, and mean dose during the last week of treatment of peginesatide.|Month 6 - 12|Participants who received at least 1 dose of study treatment during the Peginesatide Treatment Period.|||mg||Standard Deviation|Mean
2671214|NCT01478971|Primary|Percentage of Participants Undergoing Conversion to Peginesatide Injection||6 months|All participants who received at least one dose of study treatment.|||percentage of participants|||Number
2671215|NCT01478958|Secondary|Microvascular Reactivity (Laser Doppler Imaging With Iontophoresis)|Laser Doppler imaging (LDI) with iontophoresis of acetylcholine (Ach; endothelium-dependent vasodilation) and sodium nitroprusside (SNP; endothelium-independent vasodilation).|4 months|||||||
2671216|NCT01478958|Secondary|Vascular Stiffness by Pulse Wave Velocity (PWV), Pulse Wave Analysis (PWA) and Digital Volume Pulse (DVP)|PWV (m/s) PWA produces Augmentation Index (AIx; %) DVP produces Stiffness Index (SI; m/s) and Reflection Index (RI; %)|4 months|||||||
2671217|NCT01478958|Secondary|24-hour Ambulatory Blood Pressure|24-hour, daytime and night-time measures of systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse pressure (PP; SBP-DBP) and heart rate (HR)|4 months|||||||
2671218|NCT01478958|Secondary|Cardiovascular Risk Factors (Lipids, Inflammatory Markers, Indices of Insulin Resistance, Cell Microparticles, Endothelial Progenitor Cells)|Data for fasting serum lipids (total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), TC:HDL-C ratio, low-density lipoprotein cholesterol (LDL-C), triacylglycerol (TAG)).|4 months|||||||
2671219|NCT01478958|Primary|Percent Change in Flow Mediated Dilatation (FMD)||Baseline, 4 months|Number of participants analyzed: n=171. n=24 were images of poor quality that could not be analyzed successfully.|||post-occlusion diameter change as %||Standard Error|Mean
2671220|NCT01478854|Secondary|"Volume (cc) of NPC for Sparing Region"|"The volume of the NPC_for_sparing region as collected using the Pinnacle treatment planning system."|day 1 of radiation therapy|Data was not collected for this outcome measure||||||
2671221|NCT01478854|Secondary|Radiation Dose to Spared NPC Region|The mean radiation dose (cGy) to spared NPC region (hippocampus, subventricular zone [SVZ]) in reference to site of lesion.|Day 1 of radiation therapy||||centigray (cGy)||Full Range|Mean
2671469|NCT01475955|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline Week 24||||participants|||Number
2671222|NCT01478854|Secondary|Change in Neurocognitive Function (Total Recall, Delayed Recall, Recognition Discrimination) as Measured by Hopkins Verbal Learning Test-Revised (HVLT-R)|"Change in total recall, delayed recall, and recognition discrimination index as measured by HVLT-R in patients treated with NPC sparing radiation for newly diagnosed GBM. 12-item word list, composed of four words from each of the three semantic categories which the patient must learn over three trials. For each trial, the subject is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The score for total recall is the sum of all the correctly-recalled words from each trial, for a maximum of 36. Delayed recall is assessed as the number of words freely recalled 20-25 minutes after the learning trials. Recognition is assessed after 20-25 minutes where the patient is read 24 words and is asked to say yes after words from the recall list (12 targets) and no after other words (12 distractors). RDI is the number of recalled target words minus the number of recalled distractor words. A higher score reflects a better outcome."|Change from baseline to 6 months|Paired baseline and follow-up scores were only available in 14/30 participants.|||words||95% Confidence Interval|Mean
2671223|NCT01478854|Secondary|Change in Neurocognitive Function (Verbal Fluency) as Measured by Controlled Oral Word Association Test (COWAT)|Change in neurocognitive function (verbal fluency) as measured by COWAT in patients treated with NPC sparing radiation for newly diagnosed GBM. COWAT assesses verbal fluency by asking the participant to produce words for three designated letters. The test score is the total number of different words produced for all three letters. A higher score reflects a better outcome. Therefore, a positive value for change reflects an improvement in this measure.|Change from baseline to 6 months|Paired baseline and follow-up scores were only available in 14/30 participants.|||words||95% Confidence Interval|Mean
2671224|NCT01478854|Secondary|Change in Neurocognitive Function as Measured by Trail Making Test|Change in mean score of neurocognitive function as measured by Trail Making test Parts A and B in patients treated with NPC sparing radiation for newly diagnosed GBM. The Trail making score is the number of seconds spent connecting numbered circles (1-13) to circles containing letters of the alphabet (A-L) in alternating sequential order. Score ranges from 0-150 for Part A and 0-300 for Part B. A higher score reflects greater neurocognitive impairment. Therefore, a negative value for change reflects an improvement in this measure, whereas a positive value reflects worsening impairment.|Change from baseline to 6 months|Paired baseline and follow-up scores were only available in 12/30 participants.|||seconds||95% Confidence Interval|Mean
2671225|NCT01478854|Secondary|Change in Neurocognitive Function as Measured by Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) Coding Subtest|"Change in mean score of neurocognitive function (processing speed) as measured by WAIS-IV (Coding subtest) in patients treated with NPC sparing radiation for newly diagnosed GBM. The coding subtest of WAIS-IV is a visual, paper and pencil task that requires individuals to match numbers with symbols based on a key at the top of the page (Coding) by drawing the correct symbol in the boxes provided. Coding measures visual processing speed, short-term visual memory, and the ability to shift the eyes efficiently back and forth between the key and the responses. This task requires fine motor skills (using a pencil) but does not require expressive language. Minimal demands are placed on receptive language. This task also assesses the ability to sustain focus and effort for a two minutes. The score is the total number of correct responses within a given time frame, which ranges from 0-135. A higher score reflects a better outcome. A negative value for change reflects a worse outcome."|Change from baseline to 6 months|Paired baseline and follow-up scores were only available in 14/30 participants.|||correct responses||95% Confidence Interval|Mean
2671226|NCT01478854|Secondary|Distance of Tumor to Spared NPC Niches|The X-, Y-, and Z- coordinate distances in centimeters will be recorded from the most proximal point of the planning tumor volume to the closest point of the spared NPC-containing niche.|1 year|Data was not collected for this outcome measure.||||||
2671227|NCT01478854|Secondary|Extent of NPC Sparing|The extent of NPC-sparing will be recorded for each patient. Patients will be binned into 4 groups according to the volume of NPC region that receives a certain dose as follows: 1) V5Gy≤50%; 2) V5Gy ≤20%; 3) V10Gy≤20%; 4) Doses higher than levels 1-3.|1 year|Data was not collected for this outcome measure||||||
2671228|NCT01478854|Primary|Number of Participants With Local Recurrence in the Spared NPC Niches|Number of participants with local recurrence (LR) at 1 year in the spared neural progenitor cell (NPC) containing niches of the brain in patients treated with NPC sparing radiation therapy (RT) plus temozolomide for newly diagnosed glioblastoma multiforme (GBM). Local recurrence in spared area is defined as development of a new regions of T1 post gadolinium enhancement.|1 year||||Participants|||Count of Participants
2671229|NCT01478828|Secondary|Number of Participants With MYC Downregulation|Number of participants with MYC downregulation after high-dose lovastatin.|1 year|Data was not collected for this outcome measure due to early study termination.||||||
2671230|NCT01478828|Secondary|Study Compliance as Assessed by Number of Participants Who Follow All of the Study Rules.||1 year|Data was not collected for this outcome measure due to early study termination.||||||
2671231|NCT01478828|Secondary|Number of Participants With Target Inhibition of MYC and Increased Apoptosis and Proliferation|Number of participants with target inhibition of MYC and markers of increased apoptosis (cleaved caspase-3) and proliferation (Ki-67).|1 year|Data was not collected for this outcome measure due to early study termination.||||||
2671232|NCT01478828|Secondary|Pharmacodynamic Changes in Participants After the Pre-treatment Biopsy as Measured by Number of Participants With Target Inhibition of MYC|Number of participants with target inhibition of MYC in relationship with pretreatment prostate biopsy Gleason sum, Ki-67, and degree of MYC overexpression.|1 year|Data was not collected for this outcome measure due to early study termination.||||||
2671233|NCT01478828|Secondary|Change in Cholesterol Level After Lovastatin Treatments.|Change in cholesterol level with each tested dose of oral lovastatin.|1 year|Data was not collected for this outcome measure due to early study termination.||||||
2671234|NCT01478828|Secondary|Proportion of Men With MYC Target Inhibition in Prostate Tumor Tissue|Proportion of men with MYC target inhibition in prostate tumor tissue using paired tumor biopsies before and after lovastatin administration.|1 year|Data was not collected for this outcome measure due to early study termination.||||||
2671235|NCT01478828|Secondary|Number of Participants Who Experience Specific Adverse Events at Different Dosing Points Prior to Surgery.|Toxicity of the different doses of continuous daily oral lovastatin in generally healthy men with prostate cancer prior to surgery.|1 year|Data was not collected for this outcome measure due to early study termination.||||||
2671246|NCT01478594|Secondary|Progression-Free Survival Events by Tumor Placental Growth Factor (PIGF) RNA Level|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor PIGF RNA level.~RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples|||participants|||Number
2671247|NCT01478594|Secondary|Progression-Free Survival Events by Tumor VEGF-D RNA Level|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-D RNA level.~RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples|||participants|||Number
2671248|NCT01478594|Secondary|Progression-Free Survival Events by Tumor VEGF-C / VEGF-A RNA Ratio|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-C/VEGF-A RNA ratio.~RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples|||participants|||Number
2671249|NCT01478594|Secondary|Progression-Free Survival Events by Tumor VEGF-C RNA Level|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-C RNA level.~RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples|||participants|||Number
2671250|NCT01478594|Secondary|Progression-Free Survival Events by Tumor VEGF-A Ribonucleic Acid (RNA) Level|"The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline tumor VEGF-A RNA level.~RNA was purified from biopsy tissue and measured using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Since low cycle threshold (CT) values reflect high RNA expression, the inverse of CT values were used to derive tumor categories. RNA level is expressed relative to the observed median level."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available tumor biopsy RNA samples|||participants|||Number
2671251|NCT01478594|Secondary|Progression-Free Survival Events by Serum Neuropilin Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum neuropilin level. Neuropilin protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples|||participants|||Number
2671252|NCT01478594|Secondary|Progression-Free Survival Events by Serum Interleukin-8 (IL-8) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum interleukin-8 level. IL-8 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples|||participants|||Number
2671253|NCT01478594|Secondary|Progression-Free Survival Events by Soluble Vascular Endothelial Growth Factor Receptor-3 (sVEGFR-3) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum sVEGFR-3 level. sVEGFR-3 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples|||participants|||Number
2671254|NCT01478594|Secondary|Progression-Free Survival Events by Soluble Vascular Endothelial Growth Factor Receptor-2 (sVEGFR-2) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum sVEGFR-2 level. sVEGFR-2 protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples|||participants|||Number
2671265|NCT01478594|Secondary|Progression-Free Survival (PFS) Based on Independent Radiological Review (IRR)|The time from the date of randomization until the date of radiological disease progression assessed by the IRR or until death due to any cause, even in the absence of radiological progression.|3 years|Analysis was not performed due to study closure.||||||
2671255|NCT01478594|Secondary|Progression-free Survival Events by Serum VEGF-C / VEGF-A Ratio|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum VEGF-C/VEGF-A ratio. VEGF-A and VEGF-C protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the ratio is expressed relative to the observed median.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples|||participants|||Number
2671256|NCT01478594|Secondary|Progression-free Survival Events by Serum Vascular Endothelial Growth Factor-C (VEGF-C) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum VEGF-C level. VEGF-C protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples|||participants|||Number
2671257|NCT01478594|Secondary|Progression-free Survival Events by Serum Vascular Endothelial Growth Factor-A (VEGF-A) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum vascular endothelial growth factor-A (VEGF-A) level. VEGF-A protein levels were quantified using enzyme-liked immunosorbent assay (ELISA); the level of protein is expressed relative to the observed median level.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set with available serum protein samples|||participants|||Number
2671258|NCT01478594|Secondary|Progression-free Survival Events by Lactate Dehydrogenase (LDH) Level|The number of participants with a progression-free survival event (radiological progression assessed by the investigator or death due to any cause) reported by Baseline serum lactate dehydrogenase status.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set|||participants|||Number
2671259|NCT01478594|Secondary|Safety as Assessed by Physical Examination, Vital Signs, Laboratory Assessments, 12-lead Electrocardiogram (ECGs), and Adverse Events (AEs)|"An abnormality identified during a medical test is defined as an AE if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study medication or was clinically significant in the investigator's opinion.~An AE was serious if it resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly or birth defect, required or prolonged inpatient hospitalization or other medically important event.~AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute Common Terminology Criteria for Grading Adverse Events (NCI-CTCAE) Version 4.03 per the following: 1=mild; 2= moderate; 3= severe; 4= life threatening; 5=death.~Treatment-related AEs were defined as events where the relationship to study drug was marked as probably or possibly, or was missing."|From first dose through 30 days after last dose of either tivozanib or bevacizumab, until the data cut-off date of 28 February 2014. The median duration of treatment was 168.0 days in the tivozanib (tiv) arm and 162.0 days in the bevacizumab (bev) arm.|The safety analysis set consisted of all randomized participants who received at least one dose of study drug (tivozanib or bevacizumab), analyzed according to the treatment actually received.|||participants|||Number
2671260|NCT01478594|Secondary|Health Related Quality of Life (HRQoL)|Time to deterioration in HRQoL measured by Colorectal cancer (CRC) subscale of the Functional Assessment of cancer Therapy Colorectal (FACT-C) scale, change in score from baseline using the European Quality of Life - 5 Dimensions (EQ-5D) and Fact Colorectal Symptom Index (FCSI) were not evaluated due to study closure.|3 years|Analysis was not performed due to study closure.||||||
2671261|NCT01478594|Secondary|Time to Treatment Failure (TTF)|Time to Treatment Failure (TTF) is defined as the time from randomization to last dose date of tivozanib/bevacizumab. If a participant discontinued treatment for any reason, the participant was considered as an event. Participants remaining on treatment at the time of analysis were censored at date of last dose.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set|||months||95% Confidence Interval|Median
2671262|NCT01478594|Secondary|Duration of Response (DoR)|Duration of response (DoR) is defined as the time from the date of the first documented response of CR or PR (whichever is first recorded) to documented progression or death. If a participant did not progress or had not died at the time of analysis, the duration of response was censored at the date of last tumor assessment. Duration of response is only defined for participants whose best overall response was CR or PR.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Participants with a best overall response of complete response (CR) or partial response (PR).|||months||95% Confidence Interval|Median
2671263|NCT01478594|Secondary|Objective Response Rate (ORR)|"Objective response rate is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) confirmed a minimum of four weeks apart based on RECIST 1.1 criteria.~CR: Disappearance of all target and non-target lesions and no new lesions.~PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and no progression of non-target lesions and no new lesions, or, disappearance of all target lesions and persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set|||percentage of participants|||Number
2671264|NCT01478594|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from the date of randomization until the documented date of death. Participants still alive at the time of analysis were censored on the last day the participant was known to be alive.|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|Full analysis set|||months||95% Confidence Interval|Median
2671266|NCT01478594|Primary|Investigator-assessed Progression-Free Survival (PFS)|"The time from the date of randomization until objective tumor progression or death due to any cause. Objective tumor progression was determined through radiological imaging and based on the requirements of the Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1):~Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions.~Participants who did not progress or had not died at the time of the analysis were censored at the date of last tumor assessment where non-progression was documented."|From randomization until the analysis cut-off date of 13 September 2013; median time on study drug was 167 days in the tivozanib group and 162 days in the bevacizumab group.|The full analysis set included all randomized participants.|||months||95% Confidence Interval|Median
2671267|NCT01478581|Secondary|Duration of Response (DOR)|The time interval between the date of initial documentation of a response and the date of first documented evidence of progressive disease, death, or date of censoring for the subjects not progressed/died. The censoring date is the last adequate tumor assessment date.|up to 3 Years|Responders|||Month||95% Confidence Interval|Median
2671268|NCT01478581|Secondary|Duration of Clinical Benefit Response (DCB)|DCB is defined as the time from first observation of response to the time of disease progression.|From the date of first study treatment until disease progression per IMWG, up to 60 months|Clinical benefit responders.|||Months||Full Range|Median
2671269|NCT01478581|Secondary|Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Metabolite-to-Parent Ratio for AUC0-24h (M/P AUC0-24h)|Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Calculated as (PCI-45227 AUC0-24h/PCI-45227 molecular weight)/(ibrutinib AUC0-24h/ibrutinib molecular weight) on Day 8.|Procedure was performed up to 60 weeks.|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||Ratio||Standard Deviation|Mean
2671270|NCT01478581|Secondary|Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Metabolite-to-Parent Ratio for Cmax (M/P Cmax)|Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Calculated as (PCI-45227 Cmax/PCI-45227 molecular weight)/(ibrutinib Cmax/ibrutinib molecular weight) on Day 8.|Procedure was performed up to 60 weeks.|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||Ratio||Standard Deviation|Mean
2671271|NCT01478581|Secondary|Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Accumulation Ratio for AUC0-24h (Acc. Ratio AUC0-24h)|Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Acc. Ratio calculated as Day 8 ibrutinib AUC0-24h/ Day 1 ibrutinib AUC0-24h.|Procedure was performed up to 60 weeks.|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||Ratio||Standard Deviation|Mean
2671272|NCT01478581|Secondary|Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Terminal Elimination Half-life (t1/2,Term).|Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Ibrutinib terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic plasma concentration-time curve, calculated as 0.693/λz on Day 8.|Procedure was performed up to 60 weeks.|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||hours||Standard Deviation|Mean
2671273|NCT01478581|Secondary|Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h).|Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Ibrutinib AUC0-24h calculated using linear trapezoidal summation after dosing from time 0 to 24 hours on Day 8.|Procedure was performed up to 60 weeks.|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||h∙ng/mL||Standard Deviation|Mean
2671274|NCT01478581|Secondary|Pharmacokinetics (PK) (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Time to Maximum Observed Plasma Concentration (Tmax).|Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Time to corresponding maximum observed plasma concentration of ibrutinib during the dosing interval on Day 8.|Procedure was performed up to 60 weeks.|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||hours||Standard Deviation|Mean
2671275|NCT01478581|Secondary|Pharmacokinetics (PK). (Assessed by Sampling and Testing for Drug and Metabolite Levels at Designated Time Points). Mean Maximum Observed Plasma Concentration (Cmax)|Ibrutinib and PCI-45227 concentrations were measurable following once-daily dosing of ibrutinib in subjects with MM. The following time-points were included: 0hr, 1hr, 2hr, 7hr, 24hr post-dose. Maximum observed plasma concentration of ibrutinib during the dosing interval on Day 8.|Procedure was performed up to 60 weeks.|All subjects who received at least one dose of study treatment and had evaluable pharmacokinetic data.|||ng/mL||Standard Deviation|Mean
2671276|NCT01478581|Secondary|To Evaluate the Efficacy of PCI-32765 by Assessing ORR|The objective response rate, defined as the proportion of subjects who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by the modified International Myeloma Working Group (IMWG) response criteria.|From the date of first study treatment until disease progression per IMWG, up to 60 months|All treated population|||Participants|||Count of Participants
2671317|NCT01477892|Primary|Premature Infant Pain Profile|"P0-P2 units on a scale~; changes in PIPP from baseline (P0) to procedure (needle puncture, P2)~PIPP (preterm infant pain profile)~min 0 ~ max 21~higher pain scale on higher score"|first puncture of skin(P0), 10min after remifentanil infusion (P1), 15min after remifentanil infusion (needle puncture, P2), 10min after remifentanil stop||||units on a scale||Standard Deviation|Mean
2671278|NCT01478373|Secondary|DCR (CR+PR+SD) at the End of Treatment|DCR is defined as the proportion of patients with a best overall response of CR, PR and SD at the end of dovitinib treatment according to RECIST (version 1.1). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1;Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.|Up to 9 months of estimated treatment|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.|||Percentage of Participants||90% Confidence Interval|Number
2671279|NCT01478373|Secondary|Overall Survival (OS) of Patients Treated With Dovitinib|Outcome Measure Description: OS: time from the date of entry into the study to the date of death due to any cause. A patient who has not died by the date of the analysis cut-off would have the OS censored at the time of the last contact before the cut-off date.|21 months (9 months of estimated treatment plus 12 months of survival follow up)|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.|||Months||95% Confidence Interval|Median
2671280|NCT01478373|Secondary|Overall Response Rate (ORR) of Patients Treated With Dovitinib|Outcome Measure Description: ORR: proportion of patients whose best overall response is either complete response (CR) or partial response (PR) according to RECIST (version 1.1). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1;Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.|Baseline, 12 weeks|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.|||Percentage of Participants||90% Confidence Interval|Number
2671281|NCT01478373|Secondary|Time to Tumor Progression (TTP)of Patients Treated With Dovitinib|TTP: time from the date of entry into the study to first documentation of tumor progression or death due to the underlying cancer. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|9 months|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.|||Days||95% Confidence Interval|Median
2671282|NCT01478373|Secondary|Duration of Response or Stable Disease (SD)|Duration of response or SD: time from date of entry into study to earliest date of first objective tumor progression or death. DCR is defined as proportion of patients with best overall response of CR, PR and SD at 12 weeks according to RECIST (version 1.1). CR: Disappearance of all non-nodal target lesions. Any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1; PR: At least a 30% decrease in sum of diameter of all target lesions, taking as reference the baseline sum of diameters. PD: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.|9 months|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.|||Days||Standard Deviation|Mean
2671283|NCT01478373|Secondary|Time to Treatment Failure (TTF)of Patients Treated With Dovitinib|TTF: the date of entry into the study to the earliest date of the first objective tumor progression, date of death due to any cause, or date of discontinuation due to reasons other than 'Protocol deviation' or 'Administrative problems'.|9 months|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.|||Days||95% Confidence Interval|Median
2671284|NCT01478373|Secondary|Progression-free Survival (PFS) of Patients Treated With Dovitinib|The PFS duration: time from entry into the study to the date of the first documented progression (assessed using conventional RECIST (version 1.1) or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|9 months|Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.|||Days||90% Confidence Interval|Median
2671285|NCT01478373|Primary|Antitumor Activity of Dovitinib in Terms of Disease Control Rate (DCR): Complete Response+Partial Response +Stable Disease|DCR is defined as the proportion of patients with a best overall response of Complete Responses (CR), Partial Response (PR) and Stable Disease (SD) at 12 weeks according to RECIST (version 1.1). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm 1;Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD.|12 Weeks|Full Analysis Set: all subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug.|||Percentage of Participants||90% Confidence Interval|Number
2671470|NCT01475955|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline, Week 12||||participants|||Number
2671286|NCT01478360|Primary|Improvement in the Severity of Asthma as Measured by Change in the Asthma Control Questionnaire (ACQ) Score|The ACQ scores range from 0 to 6 with lower scores reflecting better asthma control. Without loss of generality, as Day 85 minus baseline (Visit 3) so that improvements in asthma control translate to negative change scores.|Baseline and 85 Days|The Pharmacodynamics (PD) analysis set was used, and subjects were analyzed according to the treatment actually. The number of patients who had evaluable PD data at the particular PD assessment time point received.|||Score||90% Confidence Interval|Least Squares Mean
2671287|NCT01478347|Primary|Number of Subjects (Who Had Received Two Injections of rMenB+OMV NZ Vaccine in Part I of This Study) Reporting Unsolicited Adverse Events During Safety Follow-up (Part II of the Study).|The number of subjects (who had received two injections of rMenB + OMV NZ vaccine in the part I of this study) reporting unsolicited AEs during the safety follow-up in part II of the study, are reported. Unsolicited AEs in part two of the study include - AEs considered to be related to blood draw procedure and all SAEs.|Day 92 to day 331|This analysis was done on the safety set population i.e all subjects in the exposed set with unsolicited adverse event data for part two of the study.|||subjects|||Number
2671288|NCT01478347|Primary|Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91.|The number of subjects with serious adverse events (SAE), medically attended adverse events and adverse events (AEs) leading to premature withdrawal, following two injections of rMenB+OMV NZ vaccine are reported.|Day 1 to day 91|This analysis was done on the safety set population i.e all subjects in the exposed set with unsolicited adverse event data for part one of the study.|||subjects|||Number
2671289|NCT01478321|Post-Hoc|Overall Survival (OS) at 6 Months and 12 Months for Patients With Recurrent High Grade Malignant Gliomas Treated With Concurrent Radiation, Temozolomide, and Bevacizumab Followed by Adjuvant Temozolomide and Bevacizumab.|Data will be analyzed using Kaplan-Meier curves. OS is defined as the time from first re-irradiation treatment until death from any cause. Percentages of patients alive at that 6 months and 12 months will be calculated from the Kaplan-Meier curve.|At 6 and 12 months from start of treatment||||percentage of patients alive|||Number
2671290|NCT01478321|Post-Hoc|Median Progression Free Survival (PFS) for Patients With Recurrent High Grade Malignant Gliomas Treated With Concurrent Radiation, Temozolomide, and Bevacizumab Followed by Adjuvant Temozolomide and Bevacizumab|Progression Free Survival (PFS) is defined as the time from the first study treatment to the first occurrence of disease progression or death. Data will be analyzed using Kaplan-Meier curves. Tumor measurements and assessments will be based on Updated Response Assessment Criteria of High Grade Gliomas- Neuro-Oncology Working Group (RANO criteria). Tumor assessments may include either a CT or MRI scan of the brain, however the same method should be used throughout the treatment period for each patient. In general, progressive disease is defined as any of the following: ≥ 25% increase in T1 gadolinium enhancing disease, increase in T2/Flair, new lesions present or decrease in clinical status.|Range from treatment initiation 0.4-26.9 months|Only evaluable patients that completed RT treatment, with follow up imaging and data for progression were included in this endpoint.|||Months||Full Range|Median
2671291|NCT01478321|Post-Hoc|Response of Patients With Recurrent High Grade Malignant Gliomas Treated With Concurrent Radiation, Temozolomide, and Bevacizumab Followed by Adjuvant Temozolomide and Bevacizumab|"Best response is measured by CT/MRI and assessed by Updated Response Assessment Criteria of High Grade Gliomas- Neuro-Oncology Working Group (RANO criteria).~In general best response will be defined as one of the following:~Complete Response: No T1 gadolinium enhancing disease, stable or decreasing T2/FLAIR, no new lesions, no corticosteroid use and stable or increasing clinical status Partial Response: ≥ 50% decrease in T1 gadolinium enhancing disease, stable or decreasing T2/FLAIR, no new lesions,stable or decreasing use of corticosteroids, and stable or increasing clinical status Stable Disease: < 50% decrease but < 25% increase T1 gadolinium enhancing disease, stable or decreasing T2/FLAIR, no new lesions,stable or decreasing use of corticosteroids, and stable or increasing clinical status Progressive Disease is any of the following: ≥ 25% increase in T1 gadolinium enhancing disease, increase in T2/Flair, new lesions present or decrease in clinical status"|Every 8 weeks from the start of study treatment. Median time from beginning of initial radiation treatment was 25.3 months (range 8.1-82.4 months)||||Participants|||Count of Participants
2671292|NCT01478321|Secondary|Percentage of Patients With Progression Free Survival (PFS) at 6 Months and 12 Months|Progression Free Survival is defined as the time from the first study treatment to the first occurrence of disease progression or death. Data will be analyzed using Kaplan-Meier curves. Tumor measurements and assessments will be based on Updated Response Assessment Criteria of High Grade Gliomas- Neuro-Oncology Working Group (RANO criteria). Tumor assessments may include either a CT or MRI scan of the brain, however the same method should be used throughout the treatment period for each patient. In general, progressive disease is defined as any of the following: ≥ 25% increase in T1 gadolinium enhancing disease, increase in T2/Flair, new lesions present or decrease in clinical status|At 6 and 12 months after the start of treatment|Only evaluable patients that completed RT treatment, with follow up imaging and data for progression were included in this endpoint.|||percentage of patients with PFS|||Number
2671293|NCT01478321|Secondary|Safety Profile for Patients With Recurrent High Grade Malignant Gliomas Treated With Concurrent Radiation, Temozolomide, and Bevacizumab Followed by Adjuvant Temozolomide and Bevacizumab|"Toxicity will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria on Day 1 of every treatment cycle and by patient report while on study treatment and up to 30 days after the last treatment. Grade 1 - 4 adverse events (AE) where the relationship between the AE and at least one of the study drugs were considered to be definite, probable or possible, were collected and graded as:~Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE"|Completed weekly during initial phase of 5 weeks and 2 weeks recovery, then every cycle during adjuvant therapy where 1 cycle =8 weeks (for up to 7 cycles)|All patients that received at least one dose of treatment on study were eligible for this outcome measure|||participants|||Number
2671334|NCT01477749|Primary|Cumulative Total Nucleated Cell (TNC) Count|Descriptive summarization of the cumulative sum of TNC counts across infusions|Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively)||||10^9 cells/mL||Standard Error|Mean
2671294|NCT01478321|Secondary|Patient Reported Quality of Life (QOL)|"Questionnaires were completed before treatment (baseline) at the end of treatment (EOT) and after Cycle 1 and Cycle 2 of treatment (Initial phase of treatment =5 weeks + approximately 2 weeks recovery then adjuvant therapy where 1 cycle = 8 weeks). The following questionnaires were completed by patients to evaluate quality of life (QOL) at these timepoints:~FACT-Fatigue - scores from 1 to 4 with 1=not at all and 4=very much, the higher the score the more fatigue reported by the patient.~FACT-Brain (FACT Br) which included - Physcial Well-being (PWB), Social/Family Well-being (SWB), Emotional Well-being (EWB), and Functional Well-being (FWB).~Patients gave scores from 0 to 4 with 0=not at all and 4=very much, the higher the score the better the QOL reported by the patient."|Completed before treatment (baseline) after Cycle 1 (approximately week 15) and Cycle 2 (approximately week 23)of adjuvant treatment and at the end of treatment (up to 7 cycles of adjuvant treatment, where 1 cycle =8 weeks)|Only patients where sufficient data was collected for analysis were considered evaluable for this endpoint and included.|||score on a scale||Standard Deviation|Mean
2671295|NCT01478321|Primary|Overall Survival (OS) for Patients With Recurrent High Grade Malignant Gliomas Treated With Concurrent Radiation, Temozolomide, and Bevacizumab Followed by Adjuvant Temozolomide and Bevacizumab.|Data will be analyzed using Kaplan-Meier curves. OS is defined as the time from first re-irradiation treatment until death from any cause.|From treatment initiation and every 8 weeks for up to 53.5 months|All patients were eligible for this outcome measure with 2 patients not experiencing the event at time of analysis.|||Months||95% Confidence Interval|Median
2671296|NCT01478256|Secondary|Evaluate Improvement of Bacterial Cultures With Two Different Topical Antibiotics|Compare improvement of microbial cultures (greater inhibition of bacterial growth) with the two antibiotics used to treat blepharitis|Three weeks||||participants|||Number
2671297|NCT01478256|Primary|Improvement in Signs and Symptoms of Blepharitis|Signs and symptoms of blepharitis were scored and determined before and after treatment with two different antibiotics|Four weeks||||participants|||Number
2671298|NCT01478113|Secondary|Change in Functioning on Short Form-12(SF-12)|Functional improvement: Comparison between the 2 groups of changes on the SF-12 scale at Baseline and Visit 11/Early termination visit.|Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.|not able to analyze due to small sample size||||||
2671299|NCT01478113|Secondary|Change in Positive and Negative Affective Scale (PANAS)|Improvement of deficits in positive affectivity: Comparison between the 2 groups of changes on the PANAS at Baseline and Visit 11/Early Termination.|Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.|not able to analyze due to small sample size||||||
2671300|NCT01478113|Secondary|Change in Behavioral Inhibition/Activation Scale (BIS/BAS)|Improvement of deficits in behavioral activation: Comparison between the 2 groups of changes on the BIS/BAS at Baseline and Visit 11/Early Termination.|Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.|not able to analyze due to small sample size||||||
2671301|NCT01478113|Secondary|Change in the Snaith-Hamilton Pleasure Scale (SHAPS)|Improvement of anhedonia: Comparison between the 2 groups of changes on the SHAPS at Baseline and Visit 11/Early Termination.|Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.|not able to analyze due to small sample size||||||
2671302|NCT01478113|Secondary|Change in Psychological Well-being Scale (PWB)|Well-being improvement: Comparison between the 2 groups of changes on the PWB at Baseline and Visit 11/Early Termination.|Baseline to Visit 11 (which is 8 weeks of treatment) or Early Termination Visit.|not able to analyze due to small sample size||||||
2671303|NCT01478113|Primary|Change in Hamilton-Depression Rating Scale(SIGH-D)-31 Item|Comparison between the 2 groups of the percentage of participants who have responded to the treatment (response is defined here as a 50% or greater improvement on the HAM-D-31 score) between Baseline and Visit 11 or Early Termination Visit.|Baseline to Visit 11 (which is week 8 of treatment) or Early Termination Visit.|not able to analyze due to small sample size||||||
2671304|NCT01478113|Primary|Change in Hamilton-Depression Rating Scale(SIGH-D)-17 Items|Comparison between the 2 groups of the percentage of subjects in remission, as defined by a HAM-D-17 score of < 8 at endpoint visit 11/week 8 of treatment, or early termination visit.|Baseline and visit 11/week 8 of treatment, or between baseline and early termination visit.|not able to analyze due to small sample size||||||
2671305|NCT01478087|Primary|Rate of Device Related Serious Adverse Events (SAE) at 30 Days Post-treatment.||30 days post-treatment||||percentage of device related SAE|||Number
2671306|NCT01478087|Primary|Rate of Procedure Related Serious Adverse Events (SAE) at 30 Days Post-treatment.||30 Days Post Treatment||||percentage of procedure related SAE|||Number
2671307|NCT01478048|Secondary|Investigator-Assessed Objective Response Rate in Randomized Participants With at Least One FcγRIIIa V Allele|ORR was calculated for participants with a BOR of PR or better, sCR, CR, and VGPR. BOR was determined by the investigator based on myeloma tumor assessments using IMWG criteria: CR=Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal FLC ratio and absence of clonal cells in bone marrow; VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hour; PR= ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hour. ORR= number of participants responding divided by total number of participants randomized, measured as a percentage. Randomized participants with at least 1 FcγRIIIa V allele were a sub-set of all randomized participants.|Randomization until 111 events, up to May 2014, approximately 2 years|All randomized participants who had at least one FcγRIIIa V allele at randomization were analyzed.|||percentage of participants||95% Confidence Interval|Number
2671318|NCT01477853|Primary|Number of Participants Who Discontinued Study Drug Due to an Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an adverse event. Data presented exclude data following the initiation of glycemic rescue therapy.|Up to 54 weeks|All participants as treated population included all randomized participants who received at least 1 dose of study treatment.|||Participants|||Number
2671308|NCT01478048|Primary|1 Year Progression-Free Survival Rate - Randomized Participants|PFS rate=Percentage probability of participants experiencing no progression or death up to 1 year, estimated using the Kaplan-Meier method. Response assessed by the investigator: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using ATA (ie, serum and urine M-protein tests performed within 14 days of each other; imaging done if baseline measurable extramedullary plasmacytoma existed). Progression: Any of the following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.|Year 1 after last participant was randomized|All randomized participants were analyzed.|||percentage probability||95% Confidence Interval|Number
2671309|NCT01478048|Secondary|Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants|ORR was calculated for participants with a best overall response (BOR) of partial response (PR) or better, including stringent complete response (sCR), complete response (CR), and very good partial response (VGPR). BOR was determined by the investigator based on myeloma tumor assessments using IMWG criteria: CR=Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal FLC ratio and absence of clonal cells in bone marrow; VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hour; PR= ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hour. ORR= number of participants responding divided by total number of participants randomized, measured as a percentage.|Randomization until 111 events, up to May 2014, approximately 2 years|All randomized participants were analyzed.|||percentage of participants||95% Confidence Interval|Number
2671310|NCT01478048|Secondary|Median Progression-free Survival Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause, in Randomized Participants With at Least One FcγRIIIa V Allele|PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase > 100 mg/L); Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder. Randomized participants with at least 1 FcγRIIIa V allele were a sub-set of all randomized participants.|Randomization until 111 events, up to May 2014, approximately 2 years|All randomized participants who had at least one FcγRIIIa V allele were analyzed.|||Months||95% Confidence Interval|Median
2671311|NCT01478048|Primary|Number of Investigator-Assessed Progression-free Survival Events From Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants|PE planned for after at least 103 events (progression/death); analyzed at 111 events. Those who neither progressed nor died were censored on the date of last adequate tumor assessment (ATA), which requires both serum and urine M-protein tests. If no post-baseline tumor assessments/no death, then censored on randomization day. Response assessed: Day 1 (± 7 days) each cycle; 30 and 60 days post treatment. Modified IMWG criteria used. Progression: Any of following: Increase of 25% in serum and/or urine M-component; if no measurable serum, urine M-protein levels, then difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). New bone lesions or soft tissue plasmacytomas or increase in size of existing lesions, plasmacytomas. Development of hypercalcemia attributed solely to plasma cell proliferative disorder. First dose occurs within 3 days of randomization.|Randomization until 111 events, up to May 2014, approximately 2 years|Intent to treat (ITT), all randomized participants were analyzed.|||Events (progression or death)|||Number
2671312|NCT01478048|Primary|Median Investigator-Assessed Progression-free Survival (PFS) Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause - Randomized Participants|PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified International Myeloma Working Group (IMWG) criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/L); Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.|Randomization until 111 events (disease progression or death), up to May 2014, approximately 2 years|Intent to treat (ITT), all randomized participants were analyzed.|||Months||95% Confidence Interval|Median
2671313|NCT01478009|Secondary|Total Number of Days of Symptoms and Duration of All Colds|Extract of Korean red ginseng intake did not significantly reduced total number of days of symptoms and duration of all colds|up to 12 weeks|||||||
2671314|NCT01478009|Secondary|Symptom Severity of All Colds|"Subjects received the open-ended questions about symptom severity of all colds onset during study period. The symptom severity of all colds onset was checked weekly via telephone.~Symptom severity of all colds (score 0-27) was measured during study period. The original index consists of 9 Questions(Fever, Rhinorrhea, Nasal congestion, Sore throat, Cough, Sputum, Dyspnea, Headache, Myalgia).~Individual question response is assigned a score of between 0 (none) to 3 (severe) and summed to form a total score(summed) ranging from 0 (best) to 27 (worst)."|12 weeks|per protocol analysis|||Scores on a scale||Standard Deviation|Mean
2671315|NCT01478009|Primary|Frequency of ILI(Influenza Like Illness)|Subjects received the open-ended questions about frequency of ILI onset during study period. The frequency of ILI onset was checked weekly via telephone.|12 weeks|per protocol analysis|||participants|||Number
2671319|NCT01477853|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an adverse event. Data presented exclude data following the initiation of glycemic rescue therapy.|Up to 56 weeks (including 2-week follow-up)|All participants as treated population included all randomized participants who received at least 1 dose of study treatment.|||Participants|||Number
2671320|NCT01477853|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.|||Percent change||Standard Error|Mean
2671321|NCT01477853|Secondary|Percent Change From Baseline in Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.|||Percent change||Standard Error|Mean
2671322|NCT01477853|Secondary|Percent Change From Baseline in Triglycerides at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.|||Percent change||Standard Error|Mean
2671323|NCT01477853|Secondary|Percent Change From Baseline in Non-high Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.|||Percent change||Standard Error|Mean
2671324|NCT01477853|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.|||Percent change||Standard Error|Mean
2671325|NCT01477853|Secondary|Percent Change From Baseline in Total Cholesterol at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.|||Percent change||Standard Error|Mean
2671326|NCT01477853|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 16|Change from baseline reflects the Week 16 value minus the Week 0 value.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.|||mg/dL||Standard Error|Mean
2671327|NCT01477853|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 16|Percent change from baseline was calculated as the Week 16 value minus the Week 0 value, divided by the Week 0 value ×100%.|Baseline and Week 16|FAS population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.|||Percent change||Standard Deviation|Mean
2671328|NCT01477853|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 16|A1C is measured as percent. Thus, this change from baseline reflects the Week 16 A1C percent minus the Week 0 A1C percent.|Baseline and Week 16|Full analysis set (FAS) population included all participants who took at least one dose of study medication and had baseline and at least one post-randomization observation for the analysis endpoint.|||Percent||Standard Error|Mean
2671329|NCT01477762|Primary|Mean Fear-potentiated Startle to Danger Signal During Late Extinction|This measures the level of fear-potentiated startle (the difference between startle magnitude to the danger signal and baseline startle magnitude) at the end of extinction. Because the danger signal is no longer paired with the aversive stimulus like it was during the conditioning phase, the fear response should decrease from early to late extinction in individuals who show intact extinction learning.|10 hours after drug administration||||microvolts||Standard Error|Mean
2671330|NCT01477762|Primary|Mean Fear-potentiated Startle to Danger Signal During Early Extinction|Fear-potentiated startle was measured as a difference score between the startle to danger signal and the baseline. This difference score reflects the degree of fear response at the beginning of extinction.|10 hours after drug administration||||microvolts||Standard Deviation|Mean
2671331|NCT01477762|Primary|Mean Startle Magnitude to Danger Signal During Fear Conditioning|The acoustic startle response magnitude was measured using electromyography recordings of the eyeblink muscle when a sudden tone was delivered through headphones in the presence of a stimulus that was paired with an aversive outcome (i.e. the danger signal). If an individual showed successful fear learning, then startle to the danger signal would be greater than baseline startle.|10 hours after drug administration||||microvolts||Standard Error|Mean
2671332|NCT01477762|Primary|Mean Baseline Startle Magnitude During Fear Conditioning|The study measured the acoustic startle response magnitude to a sudden noise using electromyography of the eyeblink muscle. This response magnitude was used as the individual's baseline to compare to the startle magnitude to the danger signal to see if fear conditioning had occurred.|10 hours after drug administration||||microvolts||Standard Error|Mean
2671333|NCT01477749|Primary|Product Viability (Percentage)|Product viability was measured as the percentage of live PBMC in final product for infusion 1, 2, and 3 as measured by a trypan blue assay and are reported for each final product for infusion 1, 2, and 3.|Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively)||||Percentage of PBMC that are live||Full Range|Mean
2671335|NCT01477749|Primary|Cumulative CD54 Upregulation|The increase in surface CD54 on APCs, expressed as an upregulation ratio of the average number of molecules on post-culture versus pre-culture cells. Cumulative CD54 upregulation = CD54 upregulation ratio for infusion 1 + CD54 upregulation ratio for infusion 2 + CD54 upregulation ratio for infusion 3.|Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively)||||Ratio||Standard Error|Mean
2671336|NCT01477749|Primary|Cumulative CD54+ Cell Count|"Descriptive summarization of the cumulative sum of CD54+ counts across infusions.~Cumulative CD54 upregulation = CD54 upregulation for infusion 1 + CD54 upregulation for infusion 2 + CD54 upregulation for infusion 3"|Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively)||||10^9 cells/mL||Standard Error|Mean
2671337|NCT01477710|Primary|Tidal Volume|Nurses, respiratory therapists, and physicians will provide mechanical ventilation to a test instrument using three techniques of airway management. Each participant will ventilate the model using each technique for 10 minutes, in random order. During each period, the breath-to-breath tidal volume, respiratory rate, inspiratory flow, inspiratory time, and airway pressure will be recorded.|10 minutes per technique, for a total of 30 minutes per participant||||milliliters (mL)||Standard Error|Mean
2671338|NCT01477567|Secondary|Number of Participants Forming Antibody to LY3009385|The number of participants with postbaseline detection of LY3009385treatment-emergent (TE) antidrug antibodies (ADA), defined as a 4-fold increase in the ADA titer from baseline.|Baseline through Day 28|Participants who received a dose of LY3009385 or Placebo.|||participants|||Number
2671339|NCT01477567|Secondary|Change in Level of Glucagon Before and After a Standard Meal|The effect of LY3009385 on postprandial glucagon levels was assessed. Change from baseline glucagon concentrations 2 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) were calculated and summarized by treatment arm.|Baseline, Day 14|Participants who received a dose of LY3009385 or Placebo and have evaluable glucagon concentration data. The effect of LY3009385 on postprandial glucagon concentrations was not evaluated on Day 14 for the 0.3 and 1 mg treatment arms.|||picomoles per liter||Standard Deviation|Mean
2671340|NCT01477567|Secondary|Change in Level of C-peptide Before and After a Standard Meal|The effect of LY3009385 on postprandial c-peptide was assessed. Change from baseline area under the c-peptide concentration-time curve from time 0 to 4 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.|Baseline, Day 5, and Day 14|Participants who received a dose of LY3009385 or Placebo and had evaluable c-peptide concentration data.|||picomoles times hours per liter||Standard Deviation|Mean
2671341|NCT01477567|Secondary|Change in Level of Blood Glucose Before and After a Standard Meal|The effect of LY3009385 on postprandial blood glucose was evaluated. Change from baseline area under the glucose concentration-time curve from time 0 to 6 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.|Baseline, Day 5, and Day 14|Participants who received a dose of LY3009385 or Placebo and had evaluable blood glucose concentration data.|||milligrams times hours per deciliter||Standard Deviation|Mean
2671342|NCT01477567|Secondary|Pharmacokinetics: Maximum Concentration (Cmax)|The maximum observed plasma concentration (Cmax) of LY3009385 is summarized.|Predose through Day 28|Participants who received a dose of LY3009385 and had evaluable LY3009385 concentration data.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2671343|NCT01477567|Secondary|Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385|LY3009385 exposure in terms of AUC from time 0 extrapolated to infinity (AUC[0-inf]) is summarized.|Predose through Day 28|Participants who received a dose of LY3009385 and had sufficient quantifiable plasma LY3009385 concentrations in the terminal phase.|||micrograms times hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
2671344|NCT01477567|Primary|Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs|The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|Baseline through Day 28|All enrolled participants.|||participants|||Number
2671345|NCT01477463|Secondary|Incidence of Hypercalcemia for Vitamin D Toxicity|Calcium levels|2 years||||participants|||Number
2671346|NCT01477463|Secondary|Vitamin D Toxicity|serum 25(OH)D for|2 years||||ng/ml||Standard Deviation|Mean
2671347|NCT01477463|Primary|Number of Genes Differentialy Regulated in Melanoma That Showed Changes in Expression After Vitamin D Treatment|We utilized a prior gene expression study that compared malignant melanoma cells to benign nevi (moles) and identified over 2300 genes that were differentially regulated in melanoma compared to benign nevi. There were approximately 270 genes in our data set that showed changes in expression after vitamin D treatment. We wish to identify overlap between these two groups.|2 years||||number of genes|||Number
2671348|NCT01477463|Primary|Number of Genes That Showed Changes in Expression After Vitamin D Treatment|Normal cells have a complex series of molecular signals that allow communication between cells and to the cell nucleus. These signals work together to control one or more cell functions, such as cell division or cell death. Abnormal signaling activity caused by changes in gene expression can lead to cancer. An understanding of abnormal signaling, both in the tumor and in normal tissues, may lead to new therapies in cancer patients. We wish to identify changes in molecular signaling that occur in the development of melanoma that might be suppressed in benign nevi (moles) in response to vitamin D supplementation.|2 years|All subjects treated with vitamin D3.|||number of genes|||Number
2671349|NCT01477450|Primary|Return of Oxygen Saturation to Baseline (Sea Level) Values|Oxygen will be titrated from either an oxygen concentrator or an oxygen cylinder in liters per minute until the oxygen saturation returns to the sea level value. The flow in liters per minute is the dependent variables. Each participant will experience induced hypoxemia followed by cylinder oxygen delivery; each will also experience induced hypoxemia followed by pulse-dose oxygen from a concentrator.|50 minutes||||participants|||Number
2671350|NCT01477333|Primary|Change in Hemodynamic Parameter (Pulmonary Vascular Resistance Index) From Baseline to Week 24.|"Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.~Cardiopulmonary hemodynamic measurements included the following: pulmonary vascular resistance index (PVRI)."|Baseline and Week 24|Intent-to-treat population with data available at Baseline and Week 24.|||dyn*s/cm^5*m^2||Full Range|Median
2671351|NCT01477333|Primary|Change in Hemodynamic Parameter (Cardiac Index) From Baseline to Week 24.|"Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.~Cardiopulmonary hemodynamic measurements included cardiac index (CI)."|Baseline and Week 24|Intent-to-treat population with data available at Baseline and Week 24.|||L/min/m^2||Full Range|Median
2671352|NCT01477333|Primary|Change in Hemodynamic Parameter (Cardiac Output) From Baseline to Week 24.|Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.|Baseline and Week 24|Intent-to-treat population with data available at Baseline and Week 24.|||L/min||Full Range|Median
2671353|NCT01477333|Primary|Change in Hemodynamic Parameters (Arterial and Venous Oxygen Saturation) From Baseline to Week 24.|"Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.~Cardiopulmonary hemodynamic measurements included arterial oxygen saturation (SaO2) and mixed venous oxygen saturation (SvO2)."|Baseline and Week 24|Intent-to-treat population with data available at Baseline and Week 24.|||percentage bound to hemoglobin||Full Range|Median
2671354|NCT01477333|Primary|Change in Hemodynamic Parameter (Heart Rate) From Baseline to Week 24.|Heart rate was assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.|Baseline and Week 24|Intent-to-treat population with data available at Baseline and Week 24.|||beats/min||Full Range|Median
2671355|NCT01477333|Secondary|N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Over the 24-week Treatment Period.|NT-proBNP was assessed at Baseline prior to starting UT-15C SR, Weeks 12 and 24, or at the time of premature termination if prior to Week 24. Blood for NT-proBNP assessment was collected before the 6MWT was conducted.|Weeks 12 and 24|Intent-to-treat population with data available at Baseline and Week 24.|||pg/mL||Standard Deviation|Mean
2671356|NCT01477333|Secondary|Shift From Baseline in World Health Organization (WHO) Functional Class Over the 24-week Treatment Period.|The WHO functional classification for pulmonary hypertension was assessed at Baseline prior to starting UT-15C SR, Weeks 4, 8, 12, and 24, or at the time of premature termination if prior to Week 24. The WHO functional classification ranges from I (patient's disease does not affect daily activities) to IV (patient's disease causes severe impairment).|Baseline and Weeks 4, 8, 12, and 24|Intent-to-treat population with data available at Baseline and Week 24.|||participants|||Number
2671357|NCT01477333|Secondary|Time to Clinical Worsening Over the Treatment Period.|Clinical worsening was assessed continuously from Baseline through each subject's last study visit. Clinical worsening was defined as the occurrence of any one or more of the following: death (all causes), hospitalization as a result of worsening pulmonary arterial hypertension (PAH), and initiation of a parenteral prostacyclin.|Clinical worsening was assessed continuously from Baseline through each subject's last study visit|Intent-to-treat population with data available at Baseline and Week 24.|||Days||Standard Deviation|Mean
2671358|NCT01477333|Secondary|Change in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Over the 24-week Treatment Period.|The 6MWT was conducted at Baseline, 2 to 4 hours after the last Tyvaso dose, and prior to first dose of UT-15C SR. The 6MWT was also performed at Weeks 4, 12, and 24, or at the time of premature termination of study drug if prior to the Week 24 visit.|Baseline and Weeks 4, 12, and 24|Intent-to-treat population with data available at Baseline and Week 24.|||Meters||Full Range|Median
2671359|NCT01477333|Primary|Change in Hemodynamic Parameters From Baseline to Week 24.|"Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit.~Cardiopulmonary hemodynamic measurements included the following: mean pulmonary arterial pressure (PAPm), mean systemic arterial pressure (SAPm), mean right atrial pressure (RAPm), and mean pulmonary capillary wedge pressure (PCWPm)."|Baseline and Week 24|Intent-to-treat population with data available at Baseline and Week 24.|||mmHg||Full Range|Median
2671360|NCT01477320|Secondary|Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis.||Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds up to 100 weeks.||||Participants|||Count of Participants
2671361|NCT01477320|Primary|Number of Subjects With GI Bleeding|"Incidence of overt GI bleeding (as defined by the presence of coffee ground emesis, hematemesis of bright red blood, melena, or hematochezia) seen with Proton Pump Inhibitor (PPI) and EN versus EN alone in critically ill patients.~Incidence of significant GI bleeding, defined by a 3-point decrease in hematocrit within 24 hours accompanied by signs of overt GI bleeding, or by an unexplained 6-point decrease in hematocrit during any 48 hour period."|Subjects will be followed from date of randomization until discharge from the ICU or cessation of Enteral Nutrition (EN) and successful initiation of oral feeds up to 100 weeks.||||participants|||Number
2671362|NCT01477177|Secondary|Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification|The reduction of Barrett's segment length and histology classification will be measured at 6 months.|6 months|Terminated Study. Enrollment much slower than anticipated and funding issues.||||||
2671363|NCT01477177|Secondary|Assessment of Post-ablation Symptoms|Specific symptoms (frequency and severity) are chest pain, difficulty swallowing, painful swallowing, nausea or vomiting, sore throat|12 months|Terminated Study. Enrollment much slower than anticipated and funding issues.||||||
2671364|NCT01477177|Secondary|Assessment of Complications|Specific complications are GI Bleeding and Perforation and Stricture and Ulceration|12 months|Terminated Study. Enrollment much slower than anticipated and funding issues||||||
2671365|NCT01477177|Secondary|Reduction in Barrett's Segment Length, Using the Prague Classification||6 and 12 months|Terminated study. Enrollment much slower than anticipated and funding issues.||||||
2671366|NCT01477177|Primary|Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification|The reduction of Barrett's segment length and histology classification will be measured at 12 months.|12 months|Terminated study. Enrollment much slower than anticipated and funding issues.||||||
2671369|NCT01476722|Primary|Corneal Fluorescein Staining Area at Day 30|Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated [i.e., 0% (no staining in the region) to 100% (staining covers entire region)], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.|Day 30|Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.|||Units on a scale||Standard Deviation|Mean
2671370|NCT01476722|Primary|Corneal Fluorescein Staining Area at Baseline|Corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. The area (extent) of corneal staining for each of the five areas was estimated [i.e., 0% (no staining in the region) to 100% (staining covers entire region)], for a maximum score of 100% per eye. A lower score represents a more desirable outcome.|Day 0 (Baseline)|Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.|||Units on a scale||Standard Deviation|Mean
2671371|NCT01476722|Primary|Corneal Fluorescein Staining Type at Day 30|Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.|Day 30|Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.|||Units on a scale||Standard Deviation|Mean
2671372|NCT01476722|Primary|Corneal Fluorescein Staining Type at Baseline|Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed, for a maximum score of 20. A lower score represents a more desirable outcome.|Day 0 (Baseline)|Intent-to-treat. All enrolled subjects who received test article and had at least 1 on-therapy visit.|||Units on a scale||Standard Deviation|Mean
2671373|NCT01476696|Secondary|Number of Participants With Hemorrhagic Events Requiring Medical Intervention|Hemorrhagic events were determined by the study investigator. Medical intervention was defined as any medical attention resulting in therapy or further investigation, as determined by a trained medical professional.|Part B: Baseline up to Day 36|Participants who received at least 1 dose of prasugrel.|||participants|||Number
2671374|NCT01476696|Secondary|Number of Participants With Pain|"The number of participants who answered yes to the first question in the Sickle Cell Disease Pain (SCD) Questionnaire is reported. Question 1: In the past 2 weeks, did you experience any sickle cell pain?"|Part B: Baseline and Day14 ± 4 days postdose in each dosing period|Participants who responded to Question 1 of the SCD Questionnaire. A participant could be counted more than once because there were 2 dosing periods during Part B of the study.|||participants|||Number
2671375|NCT01476696|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Prasugrel Inactive Metabolite|AUC of prasugrel inactive metabolite(s) from time 0 up to the last sampling time of 4 hours postdose [AUC(0-tlast)]. Improvements in bioanalytical methodology enabled direct measurement of Pras-AM from plasma, obviating the need to estimate its concentration from inactive downstream metabolite(s). Thus, the AUC of prasugrel inactive metabolite(s) was not analyzed.|Part A: 0.5, 1, 1.5, 2, 4 hours postdose|No participants were analyzed.||||||
2671376|NCT01476696|Primary|Percentage of Platelet Inhibition as Measured by VerifyNow™P2Y12 (VN)|Accumetrics VN assay: A point-of-care device that measures platelet aggregation. Percentage of platelet inhibition is reported by dose administered [0.03, 0.05, 0.07, 0.09, 0.11, 0.13, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, and 0.6 milligrams per kilogram (mg/kg)] during Part A (single-dose range finding phase) and also during the once-daily repeated dosing phase in Part B, at steady state, 14 ± 4 days after each new dose (0.06, 0.08, and 0.12 mg/kg) is administered. One participant received the same dose at multiple visits (Part A) and one participant received the same daily dose during both dosing periods in Part B.|Part A: 4 hours postdose and Part B: at steady state (14 ± 4 days after the start of each new dosage)|Participants who received at least 1 dose of prasugrel.|||percentage of platelet inhibition||Standard Deviation|Mean
2671377|NCT01476696|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Prasugrel Active Metabolite (Pras-AM)|AUC of Pras-AM from time 0 up to the last sampling time of 4 hours postdose [AUC(0-tlast)] is reported by dose administered [0.03, 0.05, 0.07, 0.09, 0.11, 0.13, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, and 0.6 milligrams per kilogram (mg/kg)] during Part A (single-dose range finding phase) and is reported for doses administered on site (0.06, 0.08, and 0.12 mg/kg) during Part B (once-daily repeated dosing phase) of the study. Four participants received the same dose at multiple visits where pharmacokinetic samples were collected.|Parts A and B: 0.5, 1, 1.5, 2, 4 hours postdose|Participants who received at least 1 dose of prasugrel.|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2671378|NCT01476644|Secondary|Eye Comfort With MGSS|Modified Glaucoma Symptom Scale (MGSS), is patient perception of their eyes comfort. Ten ocular complaints often associated with glaucoma each have a four level score (1 signifying very bothersome; 4 represents absence of problems). Scores from 10 questions are added and range from 0 to 100 where 0 represents significant discomfort and 100 represents no problems at all. The final MGSS score is an unweighted average of responses to 10 items, averaged between the 2 eyes. Data from visits 2 through 5.|2 hours at each annual visit, visits 2 through 5||||units on a scale||Standard Deviation|Mean
2671379|NCT01476644|Primary|Quality of Life With NEI VFQ-25|National Eye Institute Visual Function-25 questionnaire (NEI VFQ-25) is a measurement of patients perception of their visually related quality of life. Patients select answers from multiple choice lists of responses. Values are re-coded and converted to a scale of 0 to 100 where 0 is extreme difficulty and 100 is no difficulty at all (or best quality of life). Data from visits 2 through 5.|2 hours at each annual visit, visits 2 through 5||||units on a scale||Standard Deviation|Mean
2671380|NCT01476475|Secondary|Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L).Severe symptomatic hypoglycemia was an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. These episodes were associated with sufficient neuroglycopenia to induce seizure, unconsciousness or coma. All episodes in which neurological impairment was severe enough to prevent self-treatment and which were thought to place participants at risk for injury to themselves or others.|First dose of study drug up to 3 days after the last dose administration (maximum of 219 days)|Safety population that included all randomized participants who received at least 1 dose of study medication regardless of the amount of treatment administered.|||percentage of participants|||Number
2671381|NCT01476475|Secondary|Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24|Participants without any post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (for HbA1c and body weight) was available and showed non-response. Otherwise, they were counted as missing data.|Week 24|mITT population. Here, number of participants analyzed = participants with any post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart or with one of the components (for HbA1c and body weight) showing non-response based on the last post-baseline on-treatment value.|||percentage of participants|||Number
2671382|NCT01476475|Secondary|Percentage of Participants Reaching HbA1c <7% at Week 24 With no Documented Symptomatic Hypoglycemia During 24-week Treatment Period|Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of ≤70 mg/dL (3.9 mmol/L). Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one documented symptomatic hypoglycemia before the introduction of rescue medication and up to 1 day after the last injection of IMP. Otherwise, they were counted as missing data. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of IMP.|Baseline up to Week 24|mITT population. Here, number of participants analyzed = participants with at least one post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2671383|NCT01476475|Secondary|Change in 30 Minute and 1-hour Plasma Glucose Excursion From Baseline to Week 24|30-minute and 1-hour plasma glucose excursion = 30-minute and 1-hour PPG minus plasma glucose value obtained 30 minutes prior to the start of the meal and before IMP administration. Change in plasma glucose excursion was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline plasma glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2671384|NCT01476475|Secondary|Change in 30-minute and 1-hour PPG From Baseline to Week 24|The 30 minute and 1-hour PPG test measured blood glucose 30 minutes and 1-hour after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline PPG assessment during on-treatment period. Here, 'n' signifies number of participants with available data for specified category.|||mmol/L||Standard Error|Least Squares Mean
2671385|NCT01476475|Secondary|Percentage of Participants With HbA1c ≤6.5 % or <7.0 % at Week 24|On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of IMP.|Week 24|mITT population. Here, number of participants analyzed = participants with at least one post-baseline HbA1c assessment during on-treatment period.|||percentage of participants|||Number
2671386|NCT01476475|Secondary|Percentage of Participants Requiring Rescue Therapy During 24-week Treatment Period|Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. If fasting SMPG value exceed the specified limit for 3 consecutive days, the central laboratory FPG (and HbA1c after Week 12) were performed. Threshold values from Week 8 to Week 12: fasting SMPG/FPG >240 mg/dL (13.3 mmol/L), and from Week 12 to Week 30: fasting SMPG/FPG >200 mg/dL (11.1 mmol/L) or HbA1c >8%.|Baseline up to Week 24|mITT population.|||percentage of participants|||Number
2671387|NCT01476475|Secondary|Change in FPG From Baseline to Week 24|Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 1 day after the last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2671388|NCT01476475|Secondary|Average Daily Insulin Glargine Dose at Week 24|Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Week 24|mITT population. Here, number of participants analyzed = participants with insulin glargine dose measured during on-treatment period|||Units (U)||Standard Error|Least Squares Mean
2671389|NCT01476475|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 3 days after the last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.|||kg||Standard Error|Least Squares Mean
2671471|NCT01475955|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline, Week 8||||participants|||Number
2671390|NCT01476475|Secondary|Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profiles From Baseline to Week 24|Participants recorded a 7-point plasma glucose profile measured before and 2-hours after each meal and at bedtime, over a single day, once in a week before baseline, before visit Week 12 and before visit Week 24 and the average value across the profiles performed in the week before a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2671391|NCT01476475|Secondary|Change in 2-hour Plasma Glucose Excursion From Baseline to Week 24|2-hour plasma glucose excursion = 2-hour PPG minus plasma glucose value obtained 30 minutes prior to the start of the meal and before IMP administration. Change in plasma glucose excursion was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population. Here, number of participants analyzed = participants with both baseline and at least one post-baseline plasma glucose excursion assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2671392|NCT01476475|Secondary|Change in 2-hour Postprandial Plasma Glucose (PPG) From Baseline to Week 24|The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Change in PPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to the date of last injection of IMP.|Baseline, Week 24|mITT population.Here, number of participants analyzed = participants with both baseline and at least one post-baseline 2-hour PPG assessment during on-treatment period.|||mmol/L||Standard Error|Least Squares Mean
2671393|NCT01476475|Primary|Change in HbA1c From Baseline to Week 24|Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of investigational medicinal product (IMP).|Baseline, Week 24|Modified intent-to-treat (mITT) population consisted of all randomized participants received at least 1 dose of IMP and had both baseline and at least 1 post-baseline efficacy assessment. Number of participants analyzed = participants with both baseline and at least one post-baseline HbA1c assessment during on-treatment period.|||percentage of hemoglobin||Standard Error|Least Squares Mean
2671394|NCT01476449|Secondary|"Percentage of Patients Anatomically Dry."|"Spectral domain OCT will be used to check the patients' central foveal thickness at each visit and the percentage with dry maculas at months 3,6, and 12 based on spectral domain OCT measurements per the study protocol will be recorded."|24 Months||||Participants|||Count of Participants
2671395|NCT01476449|Secondary|Percentage of Patients With Best Corrected Visual Acuity (BCVA) Snellen-equivalent of 20/40 or Better.|The percentage of patients with 20/40 vision as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 20 feet.|24 months||||Participants|||Count of Participants
2671396|NCT01476449|Secondary|Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Foveal Thickness (CFT).|Evaluate the average change in the swelling from diabetic macular edema measured with the optical coherence tomography machine.|24 months||||microns||Standard Deviation|Mean
2671397|NCT01476449|Secondary|Mean Number of Injections.|The average number of intravitreal ranibizumab injections in each arm of the study will be recorded.|24 months||||injections||Standard Deviation|Mean
2671398|NCT01476449|Primary|Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision.|The ETDRS eye chart was used to assess vision at each visit, with the change through month 24 reported.|Baseline through 24 months||||ETDRS Letters||Standard Deviation|Mean
2671399|NCT01476345|Secondary|Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp Procedure|Gtot is the total glucose infusion over the clamp duration and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.|1 hour predose up to 24 hours postdose in all treatment periods|All randomized participants who received at least 1 dose of study drug and had evaluable data to calculate Gtot. Participants were analyzed based on the treatment they received.|||milligrams/kilogram (mg/kg)||Geometric Coefficient of Variation|Geometric Mean
2671400|NCT01476345|Secondary|Maximum Glucose Infusion Rate (Rmax)|Rmax is the maximum infusion rate of glucose administered intravenously needed to maintain target blood glucose level and is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.|1 hour predose up to 24 hours postdose in all treatment periods|All randomized participants who received at least 1 dose of study drug and had evaluable data to calculate Rmax. Participants were analyzed based on the treatment they received.|||milligrams/kilogram/minute (mg/kg/min)||Geometric Coefficient of Variation|Geometric Mean
2671401|NCT01476345|Primary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2963016 and Lantus||1 hour predose up to 24 hours postdose in all treatment periods|All randomized participants who received at least 1 dose of study drug and had evaluable pharmacokinetic data to calculate Cmax. Participants were analyzed based on the treatment they received.|||picomoles/Liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
2671402|NCT01476345|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 and Lantus||1 hour predose up to 24 hours postdose in all treatment periods|All randomized participants who received at least 1 dose of study drug and had evaluable pharmacokinetic data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.|||picomoles*hour/Liter (pmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2671405|NCT01476202|Secondary|Log Transformed Area Under the Curve of Nicotine Craving Score (AUC)|AUC between the baseline (pre-dose) and the time of measurement of craving on-treatment was determined.|Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25, and 30 minutes post treatment administration|Intent to Treat (ITT) Population: All randomized participants who had at least one dose of medication and provided at least one craving assessment measurement on treatment. The imputation of missing craving score was based on LOCF technique.|||Score on a scale*minutes||95% Confidence Interval|Log Mean
2671406|NCT01476202|Primary|Mean Change From Baseline in Nicotine Craving Score on a VAS|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score was measured.|Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25 and 30 minutes post treatment administration|Intent to Treat (ITT) Population: All randomized participants who had at least one dose of medication and provided at least one craving assessment measurement on treatment. The imputation of missing craving score was based on last observation carried forward (LOCF) technique.|||Score on a scale||Standard Deviation|Mean
2671407|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 7|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671408|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 6|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671409|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 5|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 8|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671410|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 4|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671411|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 3|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671412|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Visit 2|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|24-48 hours after PDT #1||||participants|||Number
2671413|NCT01475955|Secondary|Oozing/Vesiculation/Crusting at Baseline|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline||||participants|||Number
2671414|NCT01475955|Secondary|Scaling and Dryness at Visit 7|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671472|NCT01475955|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline, Week 4||||participants|||Number
2671415|NCT01475955|Secondary|Scaling and Dryness at Visit 6|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671416|NCT01475955|Secondary|Scaling and Dryness at Visit 5|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 8|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671417|NCT01475955|Secondary|Scaling and Dryness at Visit 4|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671418|NCT01475955|Secondary|Scaling and Dryness at Visit 3|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Week 2||||participants|||Number
2671419|NCT01475955|Secondary|Scaling and Dryness at Visit 2|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|24-48 hours after PDT #1||||participants|||Number
2671420|NCT01475955|Secondary|Scaling and Dryness at Baseline|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline||||participants|||Number
2671421|NCT01475955|Secondary|Stinging/Burning at Visit 7|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671422|NCT01475955|Secondary|Stinging/Burning at Visit 6|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671423|NCT01475955|Secondary|Stinging/Burning at Visit 5 Post PDT#2|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|5 minutes post PDT #2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671424|NCT01475955|Secondary|Stinging/Burning at Visit 5 During PDT#2|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|during PDT #2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671425|NCT01475955|Secondary|Stinging/Burning at Visit 5 (Pre-drug)|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 8 prior to drug|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671426|NCT01475955|Secondary|Stinging/Burning at Visit 4|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671427|NCT01475955|Secondary|Stinging/Burning at Visit 3|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671473|NCT01475955|Secondary|Complete Clearance Rate|the proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area|Week 24||||participants|||Number
2671428|NCT01475955|Secondary|Stinging/Burning at Visit 2|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|24-48 hours post PDT #1||||participants|||Number
2671429|NCT01475955|Secondary|Stinging/Burning Post Light-Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|5 minutes post PDT #1||||participants|||Number
2671430|NCT01475955|Secondary|Stinging/Burning During Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|During PDT #1 (most intense sensation)||||participants|||Number
2671431|NCT01475955|Secondary|Stinging/Burning at Baseline|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.|Baseline||||participants|||Number
2671432|NCT01475955|Secondary|Edema at Week 24|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671433|NCT01475955|Secondary|Edema at Week 12|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671434|NCT01475955|Secondary|Edema Post PDT #2|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 minutes post PDT #2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671435|NCT01475955|Secondary|Edema at Visit 5 (Pre-drug)|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 8 pre-drug|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671436|NCT01475955|Secondary|Edema at Visit 4|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671437|NCT01475955|Secondary|Edema at Visit 3|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671438|NCT01475955|Secondary|Edema at Visit 2|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|24-48 hours post PDT#1||||participants|||Number
2671439|NCT01475955|Secondary|Edema Post-Light Treatment|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 minutes after PDT #1||||participants|||Number
2671440|NCT01475955|Secondary|Edema at Baseline|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline||||participants|||Number
2671441|NCT01475955|Secondary|Erythema at Visit 7|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671442|NCT01475955|Secondary|Erythema at Visit 6|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671443|NCT01475955|Secondary|Erythema at Visit 5 (Post-light)|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 8 5 minutes post light treatment|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671444|NCT01475955|Secondary|Erythema at Visit 5 (Pre-drug)|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 8 pre-drug|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671445|NCT01475955|Secondary|Erythema at Visit 4|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671446|NCT01475955|Secondary|Erythema at Visit 3|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671447|NCT01475955|Secondary|Erythema at Visit 2|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|24-48 hours after PDT #1||||participants|||Number
2671448|NCT01475955|Secondary|Erythema Post-Light Treatment|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 minutes after PDT #1||||participants|||Number
2671449|NCT01475955|Secondary|Erythema at Baseline|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline||||participants|||Number
2671450|NCT01475955|Secondary|Hypopigmentation at Visit 7|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671451|NCT01475955|Secondary|Hypopigmentation at Visit 6|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671452|NCT01475955|Secondary|Hypopigmentation at Visit 5|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 8|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671453|NCT01475955|Secondary|Hypopigmentation at Visit 4|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671454|NCT01475955|Secondary|Hypopigmentation at Visit 3|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Week 2|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671455|NCT01475955|Secondary|Hypopigmentation at Visit 2|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|24-48 Hours after PDT #1||||participants|||Number
2671456|NCT01475955|Secondary|Hypopigmentation at Baseline|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas|Baseline||||participants|||Number
2671457|NCT01475955|Secondary|Hyperpigmentation at Visit 7|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 24|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671458|NCT01475955|Secondary|Hyperpigmentation at Visit 6|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 12|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671459|NCT01475955|Secondary|Hyperpigmentation at Visit 5|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 8|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671460|NCT01475955|Secondary|Hyperpigmentation at Visit 4|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 4|Number of participants analyzed reflects ITT analysis of Tolerability Data, with no imputation techniques for missing data.|||participants|||Number
2671461|NCT01475955|Secondary|Hyperpigmentation at Visit 3|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Week 2||||participants|||Number
2671462|NCT01475955|Secondary|Hyperpigmentation at Visit 2|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|24-48 Hours after PDT #1||||participants|||Number
2671463|NCT01475955|Secondary|Hyperpigmentation at Baseline|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline||||participants|||Number
2671464|NCT01475955|Secondary|Subject Satisfaction Score|"0 = no improvement or worsening (not satisfied at all)~= slight improvement (slightly satisfied)~= moderate improvement (moderately satisfied)~= excellent improvement (very satisfied)"|Week 24||||participants|||Number
2671465|NCT01475955|Secondary|AK Clearance Rate|"AK Clearance Rate (AKCR) for a subject is defined as:~100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]"|Baseline, Week 24||||percent clearance||Standard Deviation|Median
2671466|NCT01475955|Secondary|AK Clearance Rate|"AK Clearance Rate (AKCR) for a subject is defined as:~100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]"|Baseline, Week 12||||percent clearance||Standard Deviation|Median
2671477|NCT01475851|Secondary|Number of Participants Achieving Each Indicated HBcrAg Category at Baseline,Week 24, Week 48 and Week 96|The number of participants achieving each indicated hepatitis B core-related antigen (HBcrAg) category (HBcrAg <3.0 log10, 3.0 to 4.0 log10, 4.0 to 5.0 log10, 5.0 to 6.0 log10, >=6.0 log10) (kilo units per liter [KU/L]) by study visit was summarized. The LOCF method was applied for missing values.|Baseline, Week 24, Week 48 and Week 96|FAS Population|||Participants|||Number
2671478|NCT01475851|Secondary|Number of Participants Achieving Each Indicated HBsAg Category at Baseline, Week 24, Week 48 and Week 96|The number of participants achieving each indicated hepatitis B surface antigen (HBsAg) category (HBsAg <80, 80 to 800, 800 to 8000, 8000 to 80000, >=80000) (kilo international unit per liter [KIU/L]) by study visit was summarized.|Baseline, Week 24, Week 48 and Week 96|FAS Population|||participants|||Number
2671479|NCT01475851|Secondary|Number of Participants With Virological Breakthrough and Resistance-related Mutations|"The number of participants who harbored resistance-related mutations and developed virological breakthrough was summarized. Virological breakthrough defined as HBV DNA level increase >=1 log10 copies/mL above the treatment nadir were analyzed through end of treatment. Subjects who achieved the HBV-DNA values below lower limit of quantification (LLQ) (< 2.1 log10 copies/mL) in quantitative analysis at Week 96 were also considered negative in drug-resistance without implementation of genotypic analysis. Lamivudine (LAM), adefovir pivoxil (ADV), and entecavir hydrate (ETV) resistance-related mutations were analyzed at Screening (i.e. Baseline), Week 24, Week 48 and Week 96 in participants with HBV DNA level above the lower limit of detection. Virologic breakthrough was defined as 1.0 log10 or greater increases in serum HBV DNA levels from on-treatment nadir. The LOCF method was applied for missing values."|Screening, Week 24, Week 48, Week 96 and Virological Breakthrough|FAS Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|||participants|||Number
2671480|NCT01475851|Secondary|Number of Participants Achieving HBsAg/HBsAb Seroconversion at Week 24, Week 48 and Week 96|The number of participants with hepatitis B surface antigen (HBsAg)/hepatitis B surface antibody (HBsAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBsAg and negative HBsAb participants at Baseline were summarized. HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population|||participants|||Number
2671481|NCT01475851|Secondary|Number of Participants Achieving HBsAg Loss at Week 24, Week 48 and Week 96|The number of participants with hepatitis B surface antigen (HBsAg) loss at Week 24, Week 48 and Week 96 in positive HBsAg participants at Baseline were summarized. Loss of HBsAg is defined as change of detectable HBsAg from positive to negative. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population|||participants|||Number
2671482|NCT01475851|Secondary|Number of Participants With HBeAg/HBeAb Seroconversion at Week 24, Week 48 and Week 96|The number of participants achieving hepatitis Be antigen (HBeAg)/hepatitis B e antibody (HBeAb) seroconversion at Week 24, Week 48 and Week 96 in positive HBeAg and negative HBeAb participants at Baseline were summarized. Seroconversion to HBeAg is defined as change of detectable antibody to HBeAg from negative to positive. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population|||participants|||Number
2671483|NCT01475851|Secondary|Number of Participants With HBeAg Loss at Week 24, Week 48 and Week 96|The number of participants achieving hepatitis Be antigen (HBeAg) loss at Week 24, Week 48 and Week 96 in positive HBeAg participants at Baseline were summarized. Loss of HBeAg is defined as the change of detectable HBeAg from positive to negative. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|FAS Population|||participants|||Number
2671484|NCT01475851|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Normalization at Week 24, Week 48 and Week 96|The number of participants with alanine aminotransferase (ALT) normalization at Week 24, Week 48 and Week 96 were summarized. ALT normalization is defined as when an ALT value exceeds the upper limit of normal range (ULN) at Baseline and within the normal range at the end of treatment. The LOCF method was applied for missing values.|Week 24, Week 48 and Week 96|Biochemically Evaluable Population (BEP): all participants who received at least one dose of investigational product and with an abnormal ALT at Baseline. The population for the analysis of ALT normalization was all participants with an ALT value > ULN at Baseline.|||participants|||Number
2671485|NCT01475851|Secondary|Number of Participants With Serum HBV DNA < 2.1 log10 Copies/mL at Week 48 and Week 96|The number of participants with serum HBV DNA level < the lower limit of quantitation (2.1 log10 copies/mL) (i.e., the rate of suppression) at Week 48 and Week 96 were summarized. The LOCF method was applied for missing values.|Week 48 and Week 96|FAS Population.|||participants|||Number
2671486|NCT01475851|Secondary|Mean Change From Baseline in Serum HBV DNA Level at Week 24, Week 48 and Week 96|The mean change from Baseline in the hepatitis B virus deoxyribonucleic acid (HBV DNA) level at Week 24, Week 48 and Week 96 were assessed (HBV DNA values below the lower limit of quantitation [i.e. 2.1 log10 copies/mL] for the assay were set to the lower limit minus 0.1 [i.e. 2.0 log10 copies/mL]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The Last Observation Carried Forward (LOCF) method was applied for missing values.|Baseline and Week 24, Week 48 and Week 96|FAS Population|||log10 copies/mL||95% Confidence Interval|Mean
2671487|NCT01475851|Primary|Number of Participants With HBV DNA Level < 2.1 log10 Copies/mL at Week 24|The number of participants with serum hepatitis B virus deoxyribonucleic acid (HBV DNA) level < the lower limit of quantitation (2.1 log10 copies/millilitres[copies/mL]) (i.e., the rate of suppression) at Week 24 was summarized. Statistical analysis was not provided for the number of participants achieving HBV DNA <2.1 log10 copies/mL (at Week 24). Missing values observed during the treatment period was imputed by the last observation carried forward (LOCF) method.|Week 24|Full Analysis Set (FAS) Population: all participants who received at least one dose of investigational product (IP) and had at least one efficacy assessment after the start of study treatment.|||participants|||Number
2671488|NCT01475838|Secondary|Change From Baseline in CD4+ Cell Count at Week 96||Baseline; Week 96|Participants in the Full Analysis Set with available data while on study drug were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||cells/µL||Standard Deviation|Mean
2671489|NCT01475838|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Participants in the Full Analysis Set with available data were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.|||cells/µL||Standard Deviation|Mean
2671490|NCT01475838|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 96|Full Analysis Set|||percentage of participants|||Number
2671491|NCT01475838|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48|The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.|Week 48|Full Analysis Set: Participants who were randomized and treated, and had no major eligibility criteria violations|||percentage of participants|||Number
2671492|NCT01475825|Secondary|Percent Change From Baseline To PET in Lipoprotein (a) In Cohort 2|The percent change from baseline to PET in Lipoprotein A1 was measured in participants in Cohort 2 with HeFH during the Blinded Treatment Period.|Baseline and Week 61|The full analysis set included all randomized participants who took at least 1 dose of study drug (mipomersen or placebo), had a valid baseline LDL-C measurement, and had at least 1 post-baseline LDL-C measurement.|||Percent||Standard Error|Least Squares Mean
2671493|NCT01475825|Secondary|Percent Change From Baseline To PET in Lipoprotein (a) In Cohort 1|The percent change from baseline to PET in Lipoprotein A1 was measured in participants in Cohort 1 with HeFH during the Blinded Treatment Period.|Baseline and Week 61|The full analysis set included all randomized participants who took at least 1 dose of study drug (mipomersen or placebo), had a valid baseline LDL-C measurement, and had at least 1 post-baseline LDL-C measurement.|||Percent||Standard Error|Least Squares Mean
2671494|NCT01475825|Secondary|Percent Change From Baseline To PET In Apolipoprotein B (Apo B) In Cohort 2|The percent change from baseline to PET in Apo B was measured in participants in Cohort 2 with HeFH during the Blinded Treatment Period.|Baseline and Week 61|The full analysis set included all randomized participants who took at least 1 dose of study drug (mipomersen or placebo), had a valid baseline LDL-C measurement, and had at least 1 post-baseline LDL-C measurement.|||Percent||Standard Error|Least Squares Mean
2671495|NCT01475825|Secondary|Percent Change From Baseline To PET In Apolipoprotein B (Apo B) In Cohort 1|The percent change from baseline to PET in Apo B was measured in participants in Cohort 1 with HeFH during the Blinded Treatment Period.|Baseline and Week 61|The full analysis set included all randomized participants who took at least 1 dose of study drug (mipomersen or placebo), had a valid baseline LDL-C measurement, and had at least 1 post-baseline LDL-C measurement.|||Percent||Standard Error|Least Squares Mean
2671496|NCT01475825|Secondary|Percent Change From Baseline To PET In LDL-C In Cohort 2|The percent change from baseline to PET in LDL-C was measured in Cohort 2, which included participants with HeFH with LDL-C levels ≥160 mg/dL and <200 mg/dL, plus the presence of CHD/risk equivalents.|Baseline, PET (up to 60 weeks)|The full analysis set included all randomized participants who took at least 1 dose of study drug (mipomersen or placebo), had a valid baseline LDL-C measurement, and had at least 1 post-baseline LDL-C measurement.|||Percent||Standard Error|Least Squares Mean
2671497|NCT01475825|Primary|Percent Change From Baseline To Primary Endpoint Visit (PET) In LDL-C In Cohort 1|The percent change from baseline to PET in LDL-C was measured in Cohort 1, which included participants with severe heterozygous familial hypercholesterolemia (HeFH). Severe HeFH was defined as LDL-C levels ≥200 mg/deciliter (dL) plus the presence of coronary heart disease (CHD)/risk equivalents or LDL-C levels ≥300 mg/dL regardless of the presence of CHD/risk equivalents.|Baseline and Week 61|The full analysis set for Cohort 1 included all randomized participants who took at least 1 dose of study drug in Cohort 1 (mipomersen or placebo), had a valid baseline LDL-C measurement, and had at least 1 post-baseline LDL-C measurement.|||Percent||Standard Error|Least Squares Mean
2671498|NCT01475734|Secondary|Number of Participants With Any Treatment-emergent Serious Adverse Event (SAE) and Treatment-emergent Non-serious Adverse Event (AE) During the Clamp Period|Treatment-emergent AEs are defined as those with an onset on or after study drug administration. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect.|From the time the participant consented to participate in the study through the end of the study, or the final follow-up visit for participants who discontinued active participation in the study (up to 8 study weeks)|Safety Population: all participants who received one dose of albiglutide or placebo. The Safety Population was analyzed according to treatment received.|||Participants|||Number
2671499|NCT01475734|Secondary|Average Albiglutide Concentration on the Day of the Clamp Procedure|Plasma samples were taken from participants at two time points on Day 4 (at 0 hours and 4 hours and 45 minutes post-dose) of Week 1 of the study for albiglutide study drug level analyses. The average concentration for each participant was calculated as the mean of the concentrations at 0 hours and 4 hours 45 minutes. The clamp procedure is a glucose-controlled insulin infusion system. Variable infusions of glucose are administered to achieve various glucose target levels. It is a way of quantifying insulin secretion and resistance.|Day 4|Albiglutide Pharmacokinetic Population: all participants who had at least one sample to compute albiglutide exposure|||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2671500|NCT01475734|Secondary|Recovery Time of Plasma Glucose Levels to >=3.9 mmol/L (>=70 mg/dL) From the Hypoglycemic Clamp Level of 2.8 Nmol/L (50.4 mg/dL)|The effect of albiglutide and placebo on the recovery time of plasma glucose levels to >=3.9 mmol/L (7>=0 mg/dL) from the hypoglycemic clamp level of 2.8 nmol/L (50.4 mg/dL) was calculated as the time in minutes between switching off of the insulin infusion and reaching the level of >=3.9 mmol/L (>=70 mg/dL). Censored values were censored at 70 minutes. The median and 95% confidence interval data are obtained from Kaplan-Meier estimates.|Day 4|Pharmacodynamic Population|||Minutes||95% Confidence Interval|Median
2671529|NCT01475513|Primary|Change From Baseline in Carotid Intima Media Thickness|Change in Carotid Intima Media Thickness from baseline to 6 months, measured on the right carotid artery, posterior. Lower values indicate better cardiovascular risk profile|baseline, 6 months|Data based on images. Some participants images could not be analyzed numerically.|||mm||95% Confidence Interval|Mean
2671501|NCT01475734|Secondary|C-peptide Values During the Glucose Clamp Period|C-peptide levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.|||Nanomoles per liter (nmol/L)||Standard Deviation|Geometric Mean
2671502|NCT01475734|Secondary|Cortisol Values During the Glucose Clamp Period|Cortisol levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.|||Nanomoles per liter (nmol/L)||Standard Deviation|Geometric Mean
2671503|NCT01475734|Secondary|Insulin Values During the Glucose Clamp Period|Insulin levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.|||Picomoles per liter (pmol/L)||Standard Deviation|Geometric Mean
2671504|NCT01475734|Secondary|Growth Hormone Values During the Glucose Clamp Period|Growth hormone levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.|||Micrograms per liter (µg/L)||Standard Deviation|Geometric Mean
2671505|NCT01475734|Secondary|Norepinephrine Values During the Glucose Clamp Period|Norepinephrine levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.|||Nanograms per liter (ng/L)||Standard Deviation|Geometric Mean
2671506|NCT01475734|Secondary|Epinephrine Values During the Glucose Clamp Period|Epinephrine levels were measured at all stages of glycemia during the glucose clamp period. Epinephrine levels were measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on log-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification were set to the quantification limit for summary.|Day 4|Pharmacodynamic Population. Different participants may have been analyzed at different time points (reflected by n=X, X in the category titles), so the overall number of participants analyzed reflects everyone in the Pharmacodynamic Population.|||Nanograms per liter (ng/L)||Standard Deviation|Geometric Mean
2671507|NCT01475734|Secondary|Insulin Secretion Rate (Measured by Mathematical Analysis of C-peptide Concentrations) During the Glucose Clamp Period|The insulin secretion rate (ISR) was estimated by the deconvolution of peripheral C-peptide concentrations using a 2-compartment model that utilizes population C-peptide kinetic parameters. ISR was measured at 1 hr, 1 hr 15 min, 1 hr 45 min, 2 hr, 2 hr 45 min, 3 hr, 3 hr 30 min, 3 hr 45 min, 4 hr 15 min, and 4 hr 30 min. Repeated-measures analysis of variance was performed on insulin secretion rate using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect.|Day 4|Pharmacodynamic Population|||Milliunits per hour (mU/hr)||Standard Deviation|Mean
2671508|NCT01475734|Primary|Glucagon Concentration (Nanomoles Per Liter [Nmol/L]) During the Hypoglycemic Periods of the Glucose Clamp Procedure|Plasma glucagon levels were measured for the estimation of glucagon secretion during the hypoglycemic periods. Glucagon response was measured at each clamped glucose concentration: 9 millimoles per liter (mmol/L) (0 hour [hr], 1hr, 1 hr 15 minutes [min]), 5 mmol/L (1 hr 45 min, 2 hr), 4 mmol/L (2 hr 45 min, 3 hr), 3.3 mmol/L (3 hr 30 min, 3 hr 45 min), and 2.8 mmol/L (4 hr 15 min, 4 hr 30 min), and clamp released (4 hr 45 min, 5 hr, 5 hr 15 min, 5 hr 30 min). Repeated-measures analysis of variance was performed on non-transformed pharmacodynamic parameters using a model with treatment, time, and treatment-by-time as fixed effects, and participant as a random effect. Values below the lower limit of quantification (0.03780 nmol/L) were set to the quantification limit for summary.|Day 4|Pharmacodynamic (PD) Population: all participants who received 1 dose of albiglutide or placebo, had a Baseline assessment, and had at least 1 post-Baseline assessment of the primary endpoint (glucagon) during the clamp procedure. PD Population participants were analyzed according to randomly assigned treatment.|||Nanomoles per liter (nmol/L)||Standard Deviation|Geometric Mean
2671509|NCT01475721|Secondary|Mean Rescue Medication (Albuterol/Salbutamol) Use as Puffs Per 24 Hours|Rescue medication included albuterol/salbutamol used to treat acute asthma were reported as puffs per 24 hours over a period of 6 months.|From Day 1 up to 26 weeks|mITT Population. Only those participants available at specified timepoint were analysed.|||Number of Puffs||Standard Error|Mean
2671510|NCT01475721|Secondary|Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation|An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.|From Day 1 up to 26 weeks|mITT Population|||Participants|||Number
2671511|NCT01475721|Secondary|Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death|Hospitalization was defined as an inpatient stay or a ≥24-hour stay in an observation area in an emergency department or other equivalent facility.|From Day 1 up to 26 weeks|ITT Population|||Participants|||Number
2671512|NCT01475721|Primary|Number of Participants Experiencing at Least One Asthma Exacerbation|An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.|From Day 1 up to 26 weeks|Modified intent to treat (mITT) Population comprised of participants included in the ITT population that correspond to each participant's period of exposure to study drug plus seven days after the last date of study drug treatment.|||Participants|||Number
2671513|NCT01475721|Primary|Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death)|Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a ≥24-hour stay in an observation area in an emergency department or other equivalent facility. Probability of having event was summarized with Kaplan-Meier estimates.Hazard ratio, confidence interval, and p-value are from a stratified Cox proportional hazard model, using randomization stratum as the stratification factor. The 95% CI provided in the table is actually the 95.|From Day 1 up to 26 weeks|Intent to treat (ITT) Population comprised of all participants randomized to study drug and who took study drug.|||Participants|||Number
2671514|NCT01475643|Secondary|Anterior Chamber Cells & Flare|"Anterior Chamber Flare (for those subjects that could be examined with a slit lamp):~Assessed scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0 = None No Tyndall effect~= Mild Tyndall effect barely discernible~= Moderate Tyndall effect in anterior chamber is moderately intense. Iris pattern is seen clearly~= Severe Tyndall effect in anterior chamber is severely intense. Iris pattern cannot be seen clearly~= Very severe Tyndall effect is very severely intense. The aqueous has a white and milky appearance"|Over all visits 42 days|Proportion of subjects with anterior chamber flare.|||Grade of anterior chamber flare||95% Confidence Interval|Mean
2671515|NCT01475643|Primary|Anterior Chamber Inflammation|"Anterior Chamber Inflammation (for subjects that could only be examined with a pen light and a 20D [g20 Diopter] magnifying lens): 0 = None Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal~= Mild Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal~= Moderate Moderate anterior chamber clouding~= Severe Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished~= Very severe Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished"|Postoperative Day 29|Proportion of subjects with anterior chamber inflammation|||grade of anterior chamber cells||95% Confidence Interval|Mean
2671516|NCT01475513|Secondary|Change in Triglycerides From Baseline to 6 Months|Higher values indicate higher cardiovascular risk|Baseline, 6 months||||mg/dL||95% Confidence Interval|Mean
2671517|NCT01475513|Secondary|Change in LDL From Baseline to 6 Months|Higher value indicates higher cardiovascular risk|Baseline, 6 months||||mg/dL||95% Confidence Interval|Mean
2671518|NCT01475513|Secondary|Change in Diastolic Blood Pressure From Baseline to 6 Months|Higher value indicates higher cardiovascular risk|Baseline, 6 months||||mmHg||95% Confidence Interval|Mean
2671519|NCT01475513|Secondary|Change From Baseline in Body Mass Index in 6 Months|Higher values indicate higher metabolic risk|Baseline, 6 months||||Kg/m2||95% Confidence Interval|Mean
2671520|NCT01475513|Secondary|Change From Baseline in HDL at 6 Months|Lower values indicate increased cardiovascular risk|Baseline, 6 months||||mg/dL||95% Confidence Interval|Mean
2671521|NCT01475513|Secondary|Change From Baseline in Systolic Blood Pressure at 6 Months|Higher value indicates increased cardiovascular risk|Baseline, 6 months||||mmHg||95% Confidence Interval|Mean
2671522|NCT01475513|Secondary|Change From Baseline in Areas-under-the-curve for Glucose|Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk|Baseline, 6 months||||mg/dL * min||95% Confidence Interval|Mean
2671523|NCT01475513|Secondary|Change From Baseline in Areas-under-the-curve for Insulin at 6 Months|Measured during oral glucose tolerance test. Higher values indicate increased metabolic risk|Baselines, 6 months||||mIU/mL * min||95% Confidence Interval|Mean
2671530|NCT01475513|Primary|Change From Baseline in Flow-mediated Vasodilatation|Change Flow-mediated Vasodilatation from baseline to 6 months. Higher values indicate less cardiovascular risk|Baseline, 6 months|Data based on images. Some participants images could not be analyzed numerically.|||mm||95% Confidence Interval|Mean
2671531|NCT01475513|Primary|Change From Baseline in Insulin Sensitivity|Insulin sensitivity from Frequently sampled IV glucose tolerance test (FSIVGTT), change from baseline to 6 months. Higher values indicate better insulin sensitivity|Baseline, 6 months||||min ^ -1 / mIU / L||95% Confidence Interval|Mean
2671532|NCT01475487|Secondary|Correct Landmarking|Correct landmarking by all participants between the ultrasound and digital palpation group|less than 300 seconds||||participants|||Number
2671533|NCT01475487|Secondary|Number of Attempts|Number of attempts were defined as an actual attempt to cannulate trachea or layrnx of the cadavers by the participants.|not more than 300 seconds||||participants|||Number
2671534|NCT01475487|Primary|The Primary Outcome Measure Was the Complication Rate Asssed as the Number of Participants Causing Injuries|The primary outcome measure was the complication rate as assessed by the severity of injuries; defined as the incidence and severity of posterior laryngeal and tracheal wall injuries, as graded by two anesthesiologists using the grading system described by Murphy et al,( none (no injury); mild (< 5 mm laceration); moderate (> 5mm laceration or partial puncture); severe (> 10 mm laceration or full puncture)).|On avergae less than 300 seconds||||Participants|||Number
2671535|NCT01475487|Secondary|Insertion Time|Defined as palpation of the skin to completion of procedure- cannula in trachea.|less than 5 minutes from starting of procedure||||seconds||Standard Deviation|Mean
2671536|NCT01475474|Primary|Co-primary Effectiveness Endpoint: A Relative Percentage Change in Wexner Score (or Bowel Incontinence) Severity by Comparing Post-treatment Wexner Scores to Pre-treatment (End of Baseline Period) Wexner Scores.|"The Wexner fecal incontinence scale takes into account five parameters that are scored on a scale from zero (absent) to four (daily) frequency of incontinence to gas, liquid, solid, use of pad, and quality of life. Full continence is a Wexner total of zero (0), whereas full incontinence is a Wexner total of 20.~This co-primary effectiveness endpoint is the mean % reduction in Wexner score from the baseline period to the end of the treatment period, which was calculated according to the following equation: % reduction in Wexner = 100% (baseline period Wexner - end treatment period Wexner) / (baseline period Wexner)."|Wexner score was calculated at the end of the Baseline period (Weeks 1-4) to the end of the 12-Week Treatment Period (week 16).|Primary cohort for the effectiveness analyses was the Modified Intent-To-Treat cohort which included all subjects who completed at least one week of Insert use during the 12 week Treatment Period.|||Percentage change||Inter-Quartile Range|Median
2671537|NCT01475474|Primary|Co-primary Effectiveness Endpoint: A Relative Percentage Change in Episodes of Accidental Bowel Leakage (ABL) Determined by Comparing Treatment Results to Pre-treatment Results From the Baseline Period as Measured by Daily Diary Recordings.|This co-primary effectiveness endpoint was calculated as a relative percentage of the baseline Accidental Bowel Leakage (ABL) using the following equation: % reduction in ABL = 100*(baseline period ABL - treatment period ABL) / (baseline period ABL)|Reduction in accidental bowel leakage from Baseline (Weeks 1-4) through Treatment period (Weeks 5-16).|Primary cohort for the effectiveness analyses was the Modified Intent-To-Treat cohort which included all subjects who completed at least one week of Insert use during the 12 week Treatment Period.|||percentage change||Inter-Quartile Range|Median
2671538|NCT01475461|Secondary|Number of Participants With Abnormal Laboratory Values|Hemoglobin,hematocrit,red blood cells(RBC) count:less than [<]0.8*lower limit of normal[LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],white blood cells(WBC):<0.6*LLN or >1.5*ULN,lymphocytes,total neutrophils:<0.8*LLN or >1.2*ULN, basophils,eosinophil,monocytes:>1.2*ULN;aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase:>0.3*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;total bilirubin,direct bilirubin,indirect bilirubin:>1.5*ULN;triglycerides,cholesterol:>1.3*ULN, HDL:<0.8*LLN, LDL:>1.2*ULN,blood urea nitrogen,creatinine:>1.3*ULN,uric acid:>1.2*ULN;sodium: <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,bicarbonate:<0.9*LLN or >1.1*ULN;creatine kinase:>2.0*ULN;glucose:<0.6*LLN or >1.5*ULN,urine WBC and RBC:>= 20/High Power Field [HPF]),urine epithelial cells (>=1 HPF),urine bacteria >20 high-powered field;qualitative urine glucose,urine blood to Hgb ratio (>=1);urine(protein,nitrite,mucus,leukocyte >=1 in urine dipstick test).|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.|||participants|||Number
2671539|NCT01475461|Secondary|Change From Baseline in Body Weight at Week 2, 4, 8, 12 and 14||Baseline (Day 1), Week 2, 4, 8 , 12 , 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure and n=participants who were evaluable at given time points for each group.|||kilogram (kg)||Standard Deviation|Mean
2671540|NCT01475461|Secondary|Number of Hypoglycemic Events (HAE) Episodes Per Participant|A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. Median number of events per participant was reported|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.|||events per participant||Full Range|Median
2671541|NCT01475461|Secondary|Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode|A hypoglycemic event (HAE) was identified by characteristic symptoms or blood glucose levels. HAE is defined as 1 of the given definitions: Characteristic symptoms of HAE with no home glucose monitoring performed where clinical picture included prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose; or characteristic symptoms of HAE with home glucose monitoring measurement =< 70 milligram per deciliter (mg/dL) using ACCU-CHEK plasma-referenced home glucometers or =<74 mg/dL using International Federation of Clinical Chemistry (IFCC) referenced ACCU-CHEK or central laboratory glucometers; or any laboratory glucose value, meeting the following criterion with or without accompanying symptoms: =<49 mg/dL using ACCU-CHEK plasma-referenced home glucometers or =<53 mg/dL using IFCC referenced ACCU-CHEK or central laboratory glucometers.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.|||percentage of participants|||Number
2671542|NCT01475461|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 14 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.|Baseline (Day 1) up to 14 days after last dose (up to 101 days)|Safety analysis set included all randomized participants who received at least 1 dose of study treatment.|||participants|||Number
2671543|NCT01475461|Secondary|Number of Participants With Increase/Decrease From Baseline Vital Signs Data|Participants who met the criteria for increase or decrease in vital signs data were reported. Criteria for increase or decrease from baseline vital signs data: sitting systolic blood pressure (BP) of >=30 millimeter of mercury (mmHg); sitting diastolic BP of >=20 mmHg and pulse rate was based on investigator's discretion.|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.|||participants|||Number
2671544|NCT01475461|Secondary|Number of Participants With Increase From Baseline Electrocardiogram (ECG)Data|Criteria for increase from baseline data: PR interval (percent change of greater than or equal to [>=] 25/50% [if baseline>200 then percent change of >25% counts; if baseline <=200 then percent change of >50% counts]; QRS complex (percent change of >=50%); QT Fridericia's correction (QTcF) interval (change of >=30 to <60 millisecond [msec], and change of >=60 msec).|Baseline (Day 1) up to Week 14|Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was collected for this measure.|||participants|||Number
2671545|NCT01475461|Secondary|Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as <6.5 percent by the study-specific central laboratory used and data are presented in categories of <6.5 percent and <7 percent.|Week 12|FAS: All randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was summarized for this measure.|||percentage of participants|||Number
2671546|NCT01475461|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8, 12 and 14||Baseline (Day 1), Week 1, 2, 4, 8, 12, 14|FAS: All randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was summarized for this measure and ‘n’ signifies participants who were evaluable at given time points for each group. Data for Week 1 had not been reported because as per protocol it was not intended to be collected.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2671547|NCT01475461|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4 and 8|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as <6.5 percent by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported.|Baseline(Day 1), Week 2, 4, 8|FAS: All randomized participants who received at least 1 dose of study treatment. Here, ‘N’ signifies participants for whom data was summarized for this measure and ‘n’ signifies participants who were evaluable at given time points for each group. Data for Week 2 had not been reported because as per protocol it was not intended to be collected.|||percentage of hemoglobin||Standard Deviation|Mean
2671548|NCT01475461|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average glycemic control over prolonged periods of time. The normal range for the HbA1c test, was identified as less than (<) 6.5 percent (%) by the study-specific central laboratory used. Change from baseline in percentage of HbA1c in participants were reported.|Baseline (Day 1), Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group.|||percentage of hemoglobin||Standard Deviation|Mean
2671549|NCT01475331|Primary|Number of Participants With the Changing in Cyst Volume|The primary outcome of interest will be change in cyst size, as measured on initial, 6, and 12 month CT/MRI, or as determined necessary to evaluate cyst resolution. Cyst size was calculated by measuring x and y diameters and calculating cyst volume using the formula:4/3xpxr3 where r is the average of the cyst radius as measured on the initial, 6-month, and 12-month magnetic resonance imaging or computed tomography. Response was defined according to the same volume percentage reductions as described in previous trials where: complete response is a =>95% reduction in cyst volume, partial response is a 94%-75% reduction, and anon-response is <75% reduction in volume.11 The overall ablation rates in both arms were also compared with historical controls to assess the efficacy of the chemotherapeutic cocktail.|6, and 12 months post procedure|Intent to treat population (all participants at least one dose of intervention)|||Participants|||Count of Participants
2671550|NCT01475305|Secondary|Number of Participants With Clinically Meaningful Changes From Baseline in Spirometry Values|Spirometry is a standardized assessment to evaluate lung function. Baseline values for spirometry is defined as the last measure prior to viral challenge. Spirometry assessments included percent predicted forced expiratory volume in 1 second (FEV1), FEV1/forced vital capacity (FVC), and forced expiratory flow (FEF) 25%-75% values.|Days 1, 2, 3 (Baseline), 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 31|Safety Population included all participants who received any amount of investigational product.|||participants|||Number
2671551|NCT01475305|Secondary|Number of Participants With Abnormalities in Laboratory Investigations Reported as Adverse Events (AEs)|Laboratory investigations included hematology, coagulation, serum chemistry and urinalysis parameters. Participants with abnormalities in these laboratory investigations recorded as AEs were reported.|From Day 1 through Day 91|Safety Population included all participants who received any amount of investigational product.|||participants|||Number
2671552|NCT01475305|Secondary|Number of Participants With Vital Signs Abnormalities Reported as Adverse Events (AEs)|Vital signs included temperature, respiration rate, heart rate, blood pressure. Abnormal vital sign parameters included Cardiac Disorders (Bradycardia), Respiratory, Thoracic and Mediastinal Disorders (Tachypnoea, Hyperventilation, Hypopnoea). Participants with abnormalities in these vital Signs investigations recorded as AEs were reported.|From Day 1 through Day 31|Safety Population included all participants who received any amount of investigational product.|||participants|||Number
2671553|NCT01475305|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and Day 360 that were absent before treatment or that worsened relative to pretreatment state.|From Day 1 (immediately following administration of study drug) to Day 360|Safety Population included all participants who received any amount of investigational product.|||participants|||Number
2671554|NCT01475305|Secondary|Percentage of Participants With Positive Anti-MEDI-557 Antibodies|Anti-drug antibodies in the participants blood sample were detected using a validated immunoassay. Antidrug antibodies to MEDI-557 were defined as a detectable antibody titer with a dilution value of 1:30 or greater.|Day 1 (pre-dose); Day 31, 91, 150, 180, 240, 300 and 360 post-dose|"Population for ADA included all participants who received any amount of investigational product and had >= 1 post-baseline measurement for ADA. Here, n is number of participants analysed at specific time point."|||percentage of participants|||Number
2671555|NCT01475305|Secondary|Area Under the Nasal Wash Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557|The AUC(0-t) is the area under the nasal wash concentration-time curve from time zero to any time 't'.|Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||day*nanogram per milliliter (d*ng/ml)||Standard Deviation|Mean
2671556|NCT01475305|Secondary|Time to Reach Maximum Nasal Wash Concentration (Tmax) of MEDI-557|The Tmax is defined as actual sampling time to reach maximum observed MEDI-557 concentration.|Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||Day||Standard Deviation|Mean
2671557|NCT01475305|Secondary|Maximum Nasal Wash Concentration (Cmax) of MEDI-557|The Cmax is the maximum observed nasal wash concentration of MEDI-557.|Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||nanogram per milliliter (ng/ml)||Standard Deviation|Mean
2671558|NCT01475305|Secondary|Mean Nasal Wash Concentration of MEDI-557 at Respective Time-Points|MEDI-557 nasal wash concentrations were summarized by each sampling point [LLOQ for MEDI-557 concentration assay was 20.00 nanogram per millilitre (ng/mL) for nasal wash].|Pre-dose (Day 1) and post-dose on Days 2, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, and 31|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2671559|NCT01475305|Secondary|Mean Clearance of MEDI-557|Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by the serum Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]).|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||milliliter per day (ml/d)||Standard Deviation|Mean
2671560|NCT01475305|Secondary|Volume of Distribution at Steady-State (Vss) of MEDI-557|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state which is estimated by (D/AUC[0-infinity])*(AUMC[0-infinity])/AUC[0-infinity]) where D is the dose of study drug, AUMC(0-infinity) is the area under the first moment curve extrapolated to infinity and AUC(0-infinity) is the area under the serum concentration-time curve from time zero to infinite time.|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||milliliter (ml)||Standard Deviation|Mean
2671561|NCT01475305|Secondary|Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of MEDI-557|The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||d*mcg/ml||Standard Deviation|Mean
2671562|NCT01475305|Secondary|Area Under the Serum Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of MEDI-557|The AUC(0-t) is the area under the serum concentration-time curve from time zero to any time 't'.|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||day*microgram per milliliter (d*mcg/ml)||Standard Deviation|Mean
2671585|NCT01475214|Primary|The Dose of Potassium Bicarbonate Needed for Maximal Suppression of 24-hr Urinary N-telopeptide|Describe and compare changes in urinary N-telopeptide (NTX) across the placebo and Potassium Bicarbonate (KHCO3) doses.|84 days|Healthy men and women age 60 years and older|||nmol/day||Standard Error|Mean
2671563|NCT01475305|Secondary|Serum Half Life (t1/2) of MEDI-557|Serum decay half-life is the time measured for the serum concentration to decrease by one half.|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||Day||Standard Deviation|Mean
2671564|NCT01475305|Secondary|Time to Reach Maximum Serum Concentration (Tmax) of MEDI-557|The Tmax is defined as actual sampling time to reach maximum observed MEDI-557 concentration.|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||Day||Standard Deviation|Mean
2671565|NCT01475305|Secondary|Maximum Serum Concentration (Cmax) of MEDI-557|The Cmax is the maximum observed serum concentration of MEDI-557.|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK.|||microgram per milliliter (mcg/ml)||Standard Deviation|Mean
2671566|NCT01475305|Secondary|Mean Serum MEDI-557 Concentration Through Day 360|MEDI-557 serum concentrations were summarized by each sampling point [LLOQ for MEDI-557 concentration assay was 1.56 microgram per millilitre (μg/mL) for serum].|Pre-dose (Day 1); 1,4 and 8 hours post-dose on Day 1 and post-dose on Days 2, 3, 5, 7, 9, 11, 15, 31, 61, 91, 120, 150, 180, 240, 300 and 360|Population for PK included all participants who received a full dose of investigational product and had >= 1 post-baseline measurement for PK. Here n = participants evaluable for specified categories, for each arm, respectively.|||microgram per milliliter (ug/mL)||Standard Deviation|Mean
2671567|NCT01475305|Secondary|Duration of Respiratory Syncytial Virus (RSV) Viral Shedding|Duration of viral shedding defined as the number of days from the first sample positive by any assay (that is, plaque assay culture, quantitative real-time (RT-PCR), or direct fluorescent Antibody (DFA) to the last sample positive by any assay.|From Day 5 through Day 31|Population for RSV Incidence by any Viral Assay included all participants who received both the investigational product and RSV challenge and were positive for RSV by plaque assay culture, quantitative real-time RT-PCR, or DFA.|||days||Full Range|Median
2671568|NCT01475305|Secondary|Mean Nasal RSV Peak as Measured by Quantitative Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)|RSV infection by plaque assay culture defined as positive sample for >= 2 consecutive days through 12 days post-RSV challenge.|From Day 5 through Day 31|Population for RSV Quantitative Real-Time RT-PCR Virology included all participants who received both the investigational product and RSV challenge and were positive for RSV-A by quantitative real-time RT-PCR (defined as positive samples for >= 2 consecutive days through 12 days post-RSV challenge).|||log10 copies/mL||Standard Deviation|Mean
2671569|NCT01475305|Secondary|Mean Nasal RSV Peak as Measured by Plaque Assay Culture|RSV infection by plaque assay culture defined as positive sample for >= 1 day through 12 days post-RSV challenge. log10 pfu/mL = log10 plaque-forming unit per milliliter.|From Day 5 through Day 31|Population for RSV Plaque Assay Culture Virology included all participants who received both investigational product and RSV challenge and were positive for RSV by plaque assay culture (defined as positive sample for >= 1 day through 12 days post-RSV challenge).|||log10 pfu/mL||Standard Deviation|Mean
2671570|NCT01475305|Secondary|Mean Viral Load AUC0-t by Realtime Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)|RSV infection by plaque assay culture defined as positive sample for >= 2 consecutive days through 12 days post-RSV challenge.|From Day 5 through Day 31|Population for RSV Quantitative Real-Time RT-PCR Virology included all participants who received both the investigational product and RSV challenge and were positive for RSV-A by quantitative real-time RT-PCR (defined as positive samples for >= 2 consecutive days through 12 days post-RSV challenge).|||log10 copies*day/mL||Standard Deviation|Mean
2671571|NCT01475305|Secondary|Mean Viral Load AUC0-t by Plaque Assay Culture|RSV infection by plaque assay culture defined as positive sample for >= 1 day through 12 days post-RSV challenge.|From Day 5 through Day 31|Population for RSV Plaque Assay Culture Virology included all participants who received both investigational product and RSV challenge and were positive for RSV by plaque assay culture (defined as positive sample for >=1 day through 12 days post-RSV challenge).|||log10 pfu*day/mL||Standard Deviation|Mean
2671572|NCT01475305|Secondary|Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Quantitative Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Direct Fluorescent Antibody (DFA), And by Any Method|RSV infection defined as positive quantitative real-time RT-PCR (RSV-A only) sample for >= 2 consecutive days through 12 days post-RSV challenge. A sample was determined positive if log10 copies/ml >= limit of quantitation (LLOQ; 2.80 log10 copies/mL). RSV infection defined as positive DFA sample for >= 2 consecutive days through 12 days post-RSV challenge. RSV infection by any method included positive plaque assay culture sample for >=1 day through 12 days post-RSV challenge, or positive quantitative real-time RT-PCR (RSV-A only) sample for >= 2 consecutive days through 12 days post-RSV challenge, or positive DFA sample for >=2 consecutive days through 12 days post-RSV challenge.|From Day 4 to Day 15|Population for RSV Incidence included all participants who received both the investigational product and RSV challenge.|||percentage of participants|||Number
2671573|NCT01475305|Primary|Percentage of Participants Developing Respiratory Syncytial Virus (RSV) Infection Post-RSV Challenge Measured by Plaque Assay Culture|RSV infection is defined as positive plaque assay culture sample for greater than or equal to (>=) 1 day through 12 days post-RSV challenge. A sample was determined positive if log10 plaque-forming units per milliliter [pfu/mL] greater than or equal lower limit of quantitation (LLOQ; 1.69 log10 pfu/mL) and 2 of the 3 replicates must have greater than (>) 0 pfu/mL.|From Day 4 to Day 15|Population for RSV Incidence included all participants who received both the investigational product and RSV challenge.|||percentage of participants|||Number
2671583|NCT01475253|Secondary|Percentage of Responders Using the Global Response Assessment (GRA)|Participants assessed their response to treatment using a seven item scale from Markedly improved to Markedly worse. A responder was defined as a participant who rated their symptoms as either Moderately or Markedly improved.|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||Percentage of Responders|||Number
2671574|NCT01475253|Secondary|Percentage of Participants With Change From Baseline in Cystoscopic Examination Findings|Cystoscopic examinations were performed at Baseline and Day 14. The investigator assessed the urethra and bladder for the following: visibility of ureters, stricture, erythema, presence and number of Hunner's lesion(s) and the extent of erythema. For sites with the capability, videography or high resolution digital photographs of the bladder were taken. The findings at Day 14 were compared to the findings at Baseline and were reported as Improvement, Worsening or No Change.|Baseline, Day 14|Intent-to-treat population included all enrolled participants for whom the study insertion procedure on Baseline Randomized was initiated. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||percentage of participants|||Number
2671575|NCT01475253|Secondary|Change From Baseline in Interstitial Cystitis Problem Index (ICPI) Score|Participants answered four questions about how bothersome their symptoms were over the past month using a 5 point scale: 1=No problem to 4=Big problem for a total possible score of 0 (best) to 16 worst). A negative change from Baseline indicates improvement.|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||score on a scale||Standard Deviation|Mean
2671576|NCT01475253|Secondary|Change Form Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score|Participants answered four questions about bladder/voiding symptoms over the past month. 2 questions were on a scale of 0=Not at all to 5=Almost always, 1 question on a scale of 0=Not at all to 5=5 or more times per night and 1 questions from 0=Not at all to 4=Almost always for a total possible score of 0 (best) to19 (worst). A negative change from Baseline indicates improvement|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||score on a scale||Standard Deviation|Mean
2671577|NCT01475253|Secondary|Change From Baseline in Voiding Frequency|Participants recorded Voiding Frequency in a 72 hour voiding log at Day 7, 14, 28 and 42. Lower numbers of voiding frequency is the best. A negative change from Baseline indicates improvement.|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||Voids||Standard Deviation|Mean
2671578|NCT01475253|Secondary|Change From Baseline in Urinary Urgency as Assessed by VAS|"Urinary urgency was defined as an immediate unstoppable urge to urinate which may be due to a sudden involuntary contraction of the muscular wall of the bladder and may be accompanied by discomfort in the bladder. Participants reported symptom of urinary urgency in the last 24 hours using a Urgency Visual Analogue Scale (VAS). The Urgency VAS consists of a 10 centimeter (cm) horizontal line with the words No Urgency (best) at the left end (0 cm) and the words Urgency as bad as you can imagine (worst) at the right end (10 cm). Participants were instructed to complete the Pain VAS by marking the spot on the line that corresponded to their urinary urgency. A negative change from Baseline indicates improvement."|Baseline, Days 7, 14, 28 and 42|Complete IDMC Population included all participants with available IDMC data. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||centimeters||Standard Deviation|Mean
2671579|NCT01475253|Primary|Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 42|Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.|Baseline, Day 42|Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||centimeters||Standard Deviation|Mean
2671580|NCT01475253|Primary|Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) ay Day 28|Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.|Baseline, Day 28|Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||centimeters||Standard Deviation|Mean
2671581|NCT01475253|Primary|Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 14|Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.|Baseline, Day 14|Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||centimeters||Standard Deviation|Mean
2671582|NCT01475253|Primary|Change From Baseline in Participant Reported Bladder Pain as Assessed by a Visual Analog Scale (VAS) at Day 7|Participant reported symptom of bladder pain in the prior 24 hours using a 10 centimeter (cm) horizontal line Pain Visual Analog Scale recorded in a diary. Participants were instructed to to put a mark on the line at the point that best described their bladder pain with 0 (far left on the line) reflecting no pain and 10 (far right on the line) reflecting worse possible pain. A negative change from Baseline indicates improvement.|Baseline, Day 7|Independent Data Monitoring Committee (IDMC) Population included data reviewed by the IDMC prior to study suspension. As per protocol, efficacy analyses were not performed for the Sham Cytoscopic Procedure-Randomized Study Arm/Group.|||centimeters||Standard Deviation|Mean
2671584|NCT01475214|Primary|Co-primary Aim - to Identify the Dose of KHCO3 Needed for Maximal Suppression of 24-hr Urinary Nitrogen|Describe and compare changes in 24-hour urinary nitrogen in the low and high dose and KHCO3 group and in placebo.|84 days|healthy men and women age 60 years and older|||mmol/day||Standard Error|Mean
2671586|NCT01475175|Secondary|Electrical Conduction During Sub-maximal Exercise.|Electrical conduction will be evaluated during sub-maximal exercise by measuring the subject's intrinsic AV interval.|Time Frame: Test day visit (within 14 days of enrollment)|Data were not collected.||||||
2671587|NCT01475175|Secondary|Electrical Conduction at Rest.|Electrical conduction will be evaluated at rest by measuring the subject's intrinsic atrio-ventricular (AV) interval. The AV interval is the amount time between the start of atrial contraction and the start of ventricular contraction.|Test day visit (within 14 days of enrollment)|Data were not collected.||||||
2671588|NCT01475175|Secondary|Cardiac Function With Nominal Settings During Sub-maximal Exercise.|Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction during sub-maximal exercise.|Test day visit (within 14 days of enrollment)|Data were not collected.||||||
2671589|NCT01475175|Secondary|Cardiac Function With aCRT Settings During Sub-maximal Exercise.|Difference in BP-derived and echocardiogram (echo)-derived parameters of cardiac function between BiV pacing with aCRT settings and BiV pacing with nominal settings during sub-maximal exercise.|Test day visit (within 14 days of enrollment)|Data were not collected.||||||
2671590|NCT01475175|Secondary|Cardiac Function With Nominal Settings at Rest.|Difference in BP-derived and echo-derived parameters of cardiac function between BiV pacing with nominal settings and intrinsic conduction at rest.|Test day visit (within 14 days of enrollment)|Data were not collected||||||
2671591|NCT01475175|Secondary|Cardiac Function With aCRT Settings at Rest|Difference in blood pressure (BP)-derived and echocardiogram (echo)-derived parameters of cardiac function between BiV pacing with aCRT settings and BiV pacing with nominal settings at rest.|Test day visit (within 14 days of enrollment)|Data were not collected.||||||
2671592|NCT01475175|Primary|Stroke Volume During Sub-maximal Exercise.|Difference in SV between BiV pacing with aCRT settings and BiV pacing with nominal settings during sub-maximal exercise. Sub-maximal exercise is exercise performed at a level below maximum effort. The subject will perform sub-maximal exercise to achieve target heart rate close to 75% of the age-predicted maximal heart rate.|Test day visit (within 14 days of enrollment)|Echo SV data was complete for all 12 subjects.|||mL||95% Confidence Interval|Mean
2671593|NCT01475175|Primary|Stroke Volume During Atrial Pacing.|Difference in SV between BiV pacing with aCRT settings and BiV pacing with nominal settings during atrial pacing. Atrial pacing occurs at 20 beats-per-minute (bpm) above the subject's resting heart rate.|Test day visit (within 14 days of enrollment)|Echo SV data was complete for all 12 subjects.|||mL||95% Confidence Interval|Mean
2671594|NCT01475175|Primary|Stroke Volume at Rest|Difference in stroke volume (SV) between BiV pacing with aCRT settings and BiV pacing with nominal settings at rest. Biventricular pacing is a type of pacing that paces both the right and left ventricles of the heart. Stroke volume is the volume of blood pumped from a ventricle in one heart beat.|Test day visit (within 14 days of enrollment)|Echo SV data was complete for all 12 subjects.Two patients were programmed incorrectly during the study procedure.|||mL||95% Confidence Interval|Mean
2671595|NCT01475162|Secondary|Non-relapse Mortality|Number of subjects expiring from causes other than relapse of GVHD disease.|6 months|All thirteen subjects meeting the initial eligibility criteria were included for evaluation of survival status and cause of death.|||Participants|||Count of Participants
2671596|NCT01475162|Secondary|Disease-free Survival|Number of subjects alive and not experiencing GVHD signs or symptoms at 6 and 12 months. At the six month time point, seven subjects had expired. At the 12 month time point, 10 subjects had expired.|6 and 12 months|For this analysis, all thirteen participants originally meeting eligibility criteria were included for evaluation of survival status. Living patients were evaluated for symptoms.|||Participants|||Count of Participants
2671597|NCT01475162|Secondary|Number of Subjects Experiencing at Least One Serious Adverse Event or Grade 3 Non-serious Adverse Event|Number of subjects experiencing at least one serious adverse event or adverse event of CTCAE grade 3, 4, or 5 at Day 56 following the initiation of tocilizumab therapy.|Day 56|Six subjects expired prior to day 56.|||Participants|||Count of Participants
2671598|NCT01475162|Secondary|Overall Survival|Number of subjects alive at one year.|1 year|For this analysis, all thirteen subjects meeting eligibility criteria were included.|||Participants|||Count of Participants
2671599|NCT01475162|Secondary|Discontinuation of Immunosuppression|Number of subjects for whom immunosuppressive therapy (corticosteroid, cyclosporine, tacrolimus, sirolimus, etc.) was discontinued. This will be evaluated at Day 56, Day 180 and Day 365.|Day 56, Day 180 and Day 365|Six subjects expired prior to day 56.|||Participants|||Count of Participants
2671600|NCT01475162|Secondary|GVHD Flares|Number of subjects exhibiting any progression requiring re-escalation of steroid dosing or initiation of additional topical or systemic therapy after achieving an initial complete or partial response prior to Day 90.|Day 90|Six subjects expired prior to day 90.|||Participants|||Count of Participants
2671601|NCT01475162|Secondary|Number of Patients With Partial, Mixed or no GVHD Responses|Number of subjects achieving improvement in one or more organs involved in GVHD with or without deterioration in another organ (mixed or partial response, respectively); or having received additional immune suppressive therapy (no response).|Day 56|Six subjects expired prior to day 56.|||Participants|||Count of Participants
2671602|NCT01475162|Primary|Number of Subjects Achieving Complete or Partial Response at Day 56 After Administration of Tocilizumab|Number of subjects achieving Center for International Blood and Marrow Transplant Research (CIBMTR) score of 0 (complete response); or achieving improvement in one or more organs involved in GVHD without progression in other organs (partial response). CIBMTR score of 0 means no evidence of rash or diarrhea and bilirubin less than 2.0 mg/dl. CIBMTR score of 4 means rash with bullae desquamation, lower gastrointestinal diarrhea more than 1,500 ml, and bilirubin greater than 15.1 mg/dl. Higher score means worse disease.|Day 56|6 of the thirteen subjects were not evaluable due to expiring prior to Day 56.|||Participants|||Count of Participants
2671603|NCT01475097|Secondary|Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography.|Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration.|Within 10 minutes post contrast administration.|"A recruitment error occurred with a subject in each treatment group. Therefore, the subject's efficacy data were excluded from this efficacy analysis.~This resulted in a total of 126 Iodixanol subjects and a total 125 Iopamidol subjects were used in the imaging analysis."|||participants|||Number
2671604|NCT01475097|Primary|Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography|The number of subjects experiencing overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.|Within 10 minutes post contrast administration.|249 subjects completed assessments, for overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.124 subjects received Iodixanol and 125 subjects received Iopamidol.|||participants|||Number
2671605|NCT01475071|Primary|Pain Score|Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)|Baseline (during procedure), assessed after procedure|ITT population|||units on a scale||Standard Deviation|Mean
2671606|NCT01475071|Primary|Lesion Response|Percent of lesions treated at Baseline, in complete response at Week 12|Week12|Only Per Protocol subjects are included in this analysis|||percentage of lesions complete response||Standard Deviation|Mean
2671607|NCT01474993|Secondary|Change From the Screening Visit in Heat Shock Protein Gene Expression (Relative Maximum Gene Expression) at 24 Hours After First Dose, 18 Weeks and 22 Weeks|Due to lack of resources, only the results on change from screening at the final intervention visit (18 weeks) are reported.|Screening, 24 hours after first dose of study medication, 18 weeks, 22 weeks||||fold change||Standard Deviation|Mean
2671608|NCT01474993|Secondary|Change From Screening and Baseline in Urinary Isoprostane F2α-VI Levels at 24 Hours After First Dose, at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks|*Due to lack of resources, only the results on change from screening at the final intervention visit (18 weeks) are reported.|Screening, baseline, 24 hours after first dose of study medication, 4 weeks, 10 weeks, 18 weeks, 22 weeks|*Due to lack of resources and issues with participant compliance, only the results on change from screening at the final intervention visit (18 weeks) in 13 placebo recipients are reported.|||pG/mL||Standard Deviation|Mean
2671609|NCT01474993|Secondary|Platelet Count at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks||||*10^3 cells/µL||Standard Deviation|Mean
2671610|NCT01474993|Secondary|White Blood Cell (WBC) Count at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks||||*10^3 cells/µL||Standard Deviation|Mean
2671611|NCT01474993|Secondary|Red Blood Cell (RBC) Count at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks||||*10^6 cells/µL||Standard Deviation|Mean
2671612|NCT01474993|Secondary|Thyroid Stimulating Hormone (TSH) at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks||||uIU/mL||Standard Deviation|Mean
2671613|NCT01474993|Secondary|Renal Function Tests (Serum Creatinine) at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks||||mg/dL||Standard Deviation|Mean
2671614|NCT01474993|Secondary|Liver Function Tests [Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT)] at 4 Weeks, 18 Weeks and 22 Weeks||4 weeks, 18 weeks, 22 weeks||||U/L||Standard Deviation|Mean
2671615|NCT01474993|Secondary|Ohio Autism Clinical Impressions Scale - Improvement (OACIS-I) (or CGI-I Scores) Scores at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks|"The Ohio Autism Clinical Impressions Improvement Scale (OACIS-I) is a 10 domain scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to the baseline state at the beginning of the intervention. The 10 domains cover different aspects of patients' behavior, including global autism severity, social interaction, aberrant behavior, repetitive or ritualistic behaviors, verbal communication, non-verbal communication, hyperactivity/inattention, anxiety, sensory sensitivities and restricted/narrow interests.~Each domain is rated on a scale of 1 to 7, where 1 is very much improved; 2 is much improved; 3 is minimally improved; 4 is no change; 5 is minimally worse; 6 is much worse; or 7 is very much worse."|4 weeks, 10 weeks, 18 weeks, 22 weeks||||units on a scale||Standard Deviation|Mean
2671616|NCT01474993|Secondary|Ohio Autism Clinical Global Impression Scale - Severity (OACIS-S) Scale at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks|"OACIS-S is a 10 domain scale that requires the clinician to rate the severity of the patient's autism symptoms at the time of assessment. The 10 domains cover different aspects of patients' behavior, including global autism severity, social interaction, aberrant behavior, repetitive or ritualistic behaviors, verbal communication, non-verbal communication, hyperactivity/inattention, anxiety, sensory sensitivities and restricted/narrow interests.~Each domain is rated on a scale of 1 to 7 where 1 is normal, 2 is some symptoms sometimes affecting individual and family, 3 is mild symptoms affecting individual daily and sometimes family, 4 is moderate symptoms affecting individual and family daily, 5 is marked symptoms affecting individual daily and sometimes family, 6 is severe symptoms affecting individual daily and sometimes family, and 7 is severe symptoms affecting individual and family daily."|4 weeks, 10 weeks, 18 weeks, 22 weeks||||units on a scale||Standard Deviation|Mean
2671617|NCT01474993|Secondary|Change From Screening/Baseline in Aberrant Behavior Checklist (ABC) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks|"The Aberrant Behavior Checklist has 58 questions rated by parents or teachers on a scale of 0 to 3, where a score of 0 for particular behavior is not a problem at all, 1 indicates that the behavior is a problem but slight in degree, 2 indicates that the problem is moderately serious, and 3 indicates that the problem is severe in degree. The possible ABC scores may range from 0 to 174, where higher values represent the worse outcome.~For the purposes of this study, ABC scores were obtained at both screening (the day study participants were first seen and consent obtained) and the baseline visits (the day study medication was first started, within a month of the screening visit). The screening and baseline scores were then averaged and these average ABC scores were used to calculate the change in scores at 4 weeks, 10 weeks, 18 weeks and 22 weeks respectively."|4 weeks, 10 weeks, 18 weeks, 22 weeks||||units on a scale||Standard Deviation|Mean
2671618|NCT01474993|Primary|Change From Screening/Baseline in Social Responsiveness Scale (SRS) at 4 Weeks, 10 Weeks, 18 Weeks and 22 Weeks|"The Social Responsiveness Scale is a parent- and/or teacher-reported 65 question scale. Each question on the scale inquires about an observed aspect of reciprocal social behavior that is rated on the scoring sheet on a scale from 0 to 3, where 0 is best possible behavior and 3 is the worst possible behavior. The total SRS score may range from 0 to 195 where higher values represent the worse outcome.~For the purposes of this study, SRS scores were obtained at both screening (the day study participants were first seen and consent obtained) and the baseline visits (the day study medication was first started, within a month of the screening visit). The screening and baseline scores were then averaged and these average SRS scores were used to calculate the change in scores at 4 weeks, 10 weeks, 18 weeks and 22 weeks respectively."|4 weeks, 10 weeks, 18 weeks and 22 weeks||||units on a scale||Standard Deviation|Mean
2671619|NCT01474915|Secondary|Post Operative Nausea and Vomiting (PONV) Scores on a Verbal Response Scale|"To assess the efficacy of triple therapy with Scopolamine, Ondansetron and Dexamethasone for prevention of post operative nausea and vomiting (PONV) in high risk patients during a delayed period after neurological surgery under general anesthesia.~- Assess the severity of nausea and vomiting during the first 24 hours after neurological surgery.~Nausea is evaluated by a standard verbal response scale (VRS) ranging from 0-10, 0 being no nausea and 10 being severe nausea. Vomiting is evaluated by the investigator or nursing staff numerically as either 0, no vomiting;, 1, mild vomiting;, 2, moderate vomiting;, or 3, severe vomiting."|24 hours post-operatively|Severity of nausea and vomiting|||units on a scale||Full Range|Mean
2671620|NCT01474915|Primary|Proportion of Patients With a Complete Response/Complete Control During the First 24 Hours After Neurological Surgery Under General Anesthesia|"To assess the efficacy of triple therapy with Scopolamine, Ondansetron and Dexamethasone for prevention of post operative nausea and vomiting (PONV) in high risk patients during the first 24 hours after neurological surgery under general anesthesia.~- Proportion of patients with a complete response/complete control during the first 24 hours after neurological surgery under general anesthesia.~Complete Control is defined as no emetic episode, no need for rescue medication and no more than mild nausea overall after neurological surgery and general anesthesia.~Complete Response is defined as no vomiting and no rescue therapy after neurological surgery and general anesthesia."|24 hours post operatively|Number of patients with Complete Control|||participants|||Number
2671621|NCT01474876|Secondary|Change in the Percentage of Psoriatic Arthritis Participants Who Have Paid Work|Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit.|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis who received adalimumab treatment|||Percentage of participants|||Number
2671622|NCT01474876|Primary|Percentage of Participants With Peripheral Symptoms in Remission|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission. Remission was defined as DAS28 ≤2.6 at 12 months.|Baseline (Visit 0) to 12 months|Participants with peripheral symptoms (DAS28 > 5.1 at baseline)|||Percentage of participants||95% Confidence Interval|Number
2671623|NCT01474876|Secondary|Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Psoriatic Arthritis|The Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their PsA, hours missed from work because of any other reason, number of hours worked, how much PsA affected work productivity (0= PsA had no effect,10= PsA completely prevented me from working), and how much PsA affected ability to do regular daily activities, other than work at a job (0= PsA had no effect, 10= PsA completely prevented me from doing my daily activities) in the past 7 days.|Baseline (Visit 0) to 12 months|For presenteeism, absenteeism, and total work productivity impairment endpoints: participants with psoriatic arthritis who were employed at the time of the documentation. For the total activity impairment endpoint: participants with psoriatic arthritis who received adalimumab treatment.|||Percentage change||Standard Deviation|Mean
2671624|NCT01474876|Secondary|Mean Change in Health Assessment Questionnaire Disability Index ( HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Psoriatic Arthritis|"HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being easy and 10 impossible) is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning."|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)|||Units on a scale||Standard Deviation|Mean
2671625|NCT01474876|Secondary|Predictors of Maintained Treatment Response and Remission in Participants With Psoriatic Arthritis|A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model.|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis and active axial symptoms (a baseline value of BASDAI > 4)|||Odds Ratio||95% Confidence Interval|Number
2671634|NCT01474876|Secondary|Predictors of Maintained Treatment Response and Remission in Participants With Ankylosing Spondylitis|A mathematical technique called logistic regression was performed to identify factors that could be used to predict maintained treatment response and remission. The following baseline variables were used in the logistic regression analyses: age, gender, disease of interest, result of tuberculosis screening, time since diagnosis and extra-articular manifestations (symptoms and diseases that occur in parts of the body other than joints) at baseline. The BASDAI score at baseline was forced to serve as a predictor in each model.|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis and active axial symptoms (a baseline value of BASDAI > 4)|||Odds Ratio||95% Confidence Interval|Number
2671729|NCT01474434|Secondary|Other Related Lipid Parameters (Part A)||Baseline, day 4 and day 5 of each treatment period|The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.||||||
2671626|NCT01474876|Secondary|Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Psoriatic Arthritis|BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS score consists of a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript).|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis and active axial symptoms (a baseline value of BASDAI > 4)|||Correlation coefficient|||Number
2671627|NCT01474876|Secondary|Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Psoriatic Arthritis|"The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.~The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission."|Baseline (Visit 0) to 12 months|Participants with psoriatic arthritis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)|||Units on a scale||Standard Deviation|Mean
2671628|NCT01474876|Secondary|Change in the Percentage of Ankylosing Spondylitis Participants Who Have Paid Work|Working status (Working full-time, working part-time, working at home, unemployed but seeking work, work disabled, retired, student) was documented at each study visit.|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis who received adalimumab treatment|||Percentage of participants|||Number
2671629|NCT01474876|Secondary|Mean Change in Individual Components of the Work Productivity and Activity Impairment Specific Health Problem Questionnaire in Participants With Ankylosing Spondylitis|Work Productivity and Activity Impairment (WPAI) Questionnaire is a quantitative assessment of the amount of absenteeism, presenteeism, total work productivity impairment, and total activity impairment attributable to a specific health problem (WPAI-SHP), expressed as a percentage. Participants were queried regarding their current employment status, hours missed from work because of problems associated with their AS, hours missed from work because of any other reason, number of hours worked, how much AS affected work productivity (0=AS had no effect,10= AS completely prevented me from working), and how much AS affected ability to do regular daily activities, other than work at a job (0= AS had no effect, 10= AS completely prevented me from doing my daily activities) in the past 7 days.|Baseline (Visit 0) to 12 months|For presenteeism, absenteeism, and total work productivity impairment endpoints: participants with ankylosing spondylitis who were employed at the time of the documentation. For the total activity impairment endpoint: participants with ankylosing spondylitis who received adalimumab treatment.|||Percentage change||Standard Deviation|Mean
2671630|NCT01474876|Secondary|Percentage of Participants Whose Co-medication With Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Was Stopped During the Study|Participants were surveyed at each study visit for their use of NSAID medication.|Baseline (Visit 0) to 12 months|Participants who were receiving NSAID medication at baseline|||Percentage of participants|||Number
2671631|NCT01474876|Secondary|Duration of Treatment With Adalimumab|The duration of treatment with adalimumab was calculated separately for participants who discontinued the medication during the study and for those who did not.|Baseline (Visit 0) to 12 months|Participants who received adalimumab treatment|||Months||Standard Deviation|Mean
2671632|NCT01474876|Secondary|Mean Frequency of Extra-articular Manifestations (EAMs)|Extra-articular manifestations (EAMs) are symptoms and diseases that occur in parts of the body other than joints. The number of EAMs was determined at each study visit. These included the presence of enthesitis (inflammation of ligaments and/or tendons at the site of insertion into bones), uveitis (inflammation of the middle layer of the eye), psoriasis (a skin condition that causes itchy or sore patches of thick, red skin with silvery scales), and Inflammatory bowel disease (Crohn's disease or ulcerative colitis).|Baseline (Visit 0) to 12 months|Participants who received adalimumab treatment|||Mean EAMs per participant||Standard Deviation|Mean
2671633|NCT01474876|Secondary|Mean Change in Health Assessment Questionnaire Disability Index (HAQ-DI) Score (in Case of Peripheral Symptoms) or Bath Ankylosing Spondylitis Functional Index (BASFI) Score (in Case of Axial Symptoms) in Participants With Ankylosing Spondylitis|"HAQ-DI consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, with a higher score representing a high-dependency disability. The minimal clinically important difference defined for the HAQ-DI is ≥0.22. HAQ-DI remission, indicating normal physical function, is defined as HAQ-DI < 0.5. The BASFI is a set of 10 questions designed to determine the degree of functional limitation in those with AS. A visual analogue scale (with 0 being easy and 10 impossible) is used. The BASFI score ranges from 0 to 10 and is derived as the mean of the single items. A higher score indicates a higher impairment of functioning."|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)|||Units on a scale||Standard Deviation|Mean
2671801|NCT01474200|Secondary|CLINICAL: Total Number of Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge|CV symptoms that required hospitalization for treatment within 90 days of index hospitalization discharge.|Within 30 days and 90 days after hospital discharge||||Rehospitalizations|||Number
2671635|NCT01474876|Secondary|Correlation Between Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS) in Participants With Ankylosing Spondylitis|BASDAI score (ranging from 0 to 10) was calculated using a questionnaire. Participants marked responses on a 10 cm visual analog scale ranging from 0 (none) to 10 (very severe) regarding fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline. ASDAS is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Spearman's rank correlation coefficient (CC) was calculated for BASDAI vs. ASDAS(subscript)CRP(subscript) and BASDAI vs. ASDAS(subscript)ESR(subscript ).|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis and active axial symptoms (a baseline value of BASDAI > 4)|||Correlation coefficient|||Number
2671636|NCT01474876|Secondary|Mean Change in Ankylosing Spondylitis Disease Activity Score (ASDAS)|The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Remission is defined as ASDAS score <1.3. Clinically important improvement is defined as a change ≥ 1.1 units, and major improvement is defined as a change ≥ 2.0 units.|Baseline (Visit 0) to 12 months|Participants with active axial symptoms (a baseline value of BASDAI > 4)|||Units on a scale||Standard Deviation|Mean
2671637|NCT01474876|Secondary|Mean Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (in Case of Axial Symptoms) and/or Disease Activity Score/28 Joints (DAS28) (in Case of Peripheral Symptoms) in Participants With Ankylosing Spondylitis|"The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.~The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C- reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission."|Baseline (Visit 0) to 12 months|Participants with ankylosing spondylitis with peripheral symptoms (DAS28 > 5.1 at baseline) and/or active axial symptoms (a baseline value of BASDAI > 4)|||Units on a scale||Standard Deviation|Mean
2671638|NCT01474876|Primary|Percentage of Participants With Active Axial Symptoms in Remission|The Ankylosing Spondylitis Disease Score (ASDAS) tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, duration of morning stiffness and peripheral pain/swelling assessed on a visual analogue scale (from 0 to 10 cm) or on a numerical rating scale (from 0 to 10). The laboratory parameter is a measurement of C-reactive protein (mg/L) or erythrocyte sedimentation rate (mm/h). Remission was defined as ASDAS <1.3 at 12 months.|Baseline (Visit 0) to 12 months|Participants with active axial symptoms (a baseline value of BASDAI > 4)|||Percentage of participants||95% Confidence Interval|Number
2671639|NCT01474876|Primary|Percentage of Participants With a Disease Activity Score 28 (DAS28) Decrease ≥1.2 at 12 Months Relative to Baseline|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline (Visit 0) to 12 months|Participants with peripheral symptoms (DAS28 > 5.1 at baseline)|||Percentage of participants||95% Confidence Interval|Number
2671640|NCT01474876|Primary|Percentage of Participants With a 50% or More Decrease in Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) Score at 12 Months Relative to Baseline|The BASDAI score was calculated using a questionnaire with 6 questions that the participants completed by marking responses on a 10-centimeter visual analog scale ranging from 0 (none) to 10 (very severe) regarding severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive response was defined as a 50% or more decrease in the BASDAI score at 12 months as compared to baseline.|Baseline (Visit 0) to 12 months|Participants with active axial symptoms (a baseline value of the BASDAI > 4).|||Percentage of participants||95% Confidence Interval|Number
2671641|NCT01474863|Primary|Vasopressor Dependency Index|Worst Value of Index measuring blood pressure hourly through study infusion (day 4). Vasopressor index is mean arterial blood pressure divided by catecholamine index (the catecholamine index is a dimensionless variable calculated as (dopamine dose × 1) + (dobutamine dose × 1) + (adrenaline dose × 10) + (noradrenaline × 100) + (phenylephrine dose × 100), where all doses are expressed in ug/kg/min). (Higher is better)|day 4||||mmHg/catecholamine index||Standard Deviation|Mean
2671653|NCT01474772|Secondary|Walk 12 Questionnaire Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|The Walk-12 is a self-administered questionnaire that assesses the impact of the participant's diabetic neuropathy over the past 2 weeks on parameters associated with walking (12 questions) based on a 5-point scale (from not at all to extremely). The total score is the sum of scores from the 12 questions, which then gets transferred to a 0-100 scale with higher scores indicating greater impairment|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
2671642|NCT01474772|Secondary|Euro QoL-5 Dimensions (EQ-5D) - Health State Profile Utility Scores at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The EQ-5D describes participant`s health status based on 5 attributes producing an 5 digit index score. The 5 dimensions are: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Dolan 1997 advised how to transfer this index score to a single score for clinical trials, a revised single index was published in 2001. The index uses general population weighted estimates for various health states. In general, the range of the single index tends to vary between 0 = death and 1 = perfect health and there are some states that have been rated by the general population to be worse than death which may result in numbers below 0.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
2671643|NCT01474772|Secondary|Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The HADS is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4-point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
2671644|NCT01474772|Secondary|Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4-point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
2671645|NCT01474772|Secondary|Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"The daily sleep diary consists of an 11-point numeric rating scale with which the participant rates how painful DPN pain has interfered with their sleep during the past 24 hours. Zero indicates does not interfere with sleep and 10 indicates completely interferes (unable to sleep due to pain). Self-assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight) after completion of the daily pain diary."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
2671646|NCT01474772|Secondary|Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)|The PGIC is a participant-rated instrument that measures the participant`s assessment of change in his/her overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). Original scores (OS; 7 different scores) and categorized scores (CS; 4 different scores) were provided. Categorized scores were very much improved (consisting of very much improved and much improved); any improvement (consisting of very much improved, much improved, and minimally improved); no change (consisting of no change); and any worsening (consisting of minimally worse, much worse, and very much worse). Due to the crossover design, PGIC was analyzed at the end of period 1 (V6).|End of Period 1 (V6)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).|||percentage of participants|||Number
2671647|NCT01474772|Secondary|Norfolk QOL-DN Autonomic Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). In question 31, good, the middle item, is scored as 0, very good as -1, excellent as -2, fair as 1, and poor as 2. In question 32, about the same, the middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. The autonomic domain score should be summed as follow: Σ(19, 20, 21). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
2671654|NCT01474772|Secondary|Steps Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)|Actigraphy data which measured steps and daytime activity during waking hours were assessed for the last 7 days at Baseline, Visit 6, and Visit 11. The participants were instructed to wear the device on their hip during the waking hours.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||steps||Standard Error|Least Squares Mean
2671648|NCT01474772|Secondary|Norfolk QOL-DN Small Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). In question 31, good, the middle item, is scored as 0, very good as -1, excellent as -2, fair as 1, and poor as 2. In question 32, about the same, the middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. The small fiber domain score should be summed as follow: Σ(10, 16, 17, 18). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
2671649|NCT01474772|Secondary|Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). In question 31, good, the middle item, is scored as 0, very good as -1, excellent as -2, fair as 1, and poor as 2. In question 32, about the same, the middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. The physical functioning / large fiber domain score should be summed as follow: Σ(8, 11, 13 - 15, 24, 27 - 35). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
2671650|NCT01474772|Secondary|Norfolk QOL-DN Activities of Daily Living Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). In question 31, good, the middle item, is scored as 0, very good as -1, excellent as -2, fair as 1, and poor as 2. In question 32, about the same, the middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. The activities of daily living domain score should be summed as follow: Σ(12, 22, 23, 25, 26). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
2671651|NCT01474772|Secondary|Norfolk QOL-DN Symptoms Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). In question 31, good, the middle item, is scored as 0, very good as -1, excellent as -2, fair as 1, and poor as 2. In question 32, about the same, the middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. The symptoms domain score should be summed as follow: Σ(1 - 7, 9). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
2671652|NCT01474772|Secondary|Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). In question 31, good, the middle item, is scored as 0, very good as -1, excellent as -2, fair as 1, and poor as 2. In question 32, about the same, the middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. TQOL score should be summed as follow: sum (Σ) (1 - 7, 8 - 35). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
2671730|NCT01474434|Secondary|Pharmacokinetics of Pradigastat (LCQ908): Plasma Concentration (Part A)||Part A: Day 4 and day 5 of each treatment period|The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.||||||
2673495|NCT01461655|Primary|Percentage Change in Inflammatory Lesions From Baseline to End of Treatment|Percentage change in inflammatory lesions count from baseline to the end of treatment|Baseline to End of treatment (4 weeks)||||percentage of change||Standard Deviation|Median
2671655|NCT01474772|Secondary|Daytime Total Activity Counts Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)|"Actigraphy data which measured steps and daytime activity during waking hours were assessed for the last 7 days at Baseline, Visit 6, and Visit 11. Activity counts are the units of motion. It is equal to the sum of peak accelerations each second during the epoch (60 seconds). Total activity counts per day is the sum of the activity counts for each epoch (60 seconds) during the day (non-sleep period). Actigraphy was performed with an accelerometer that was worn on the hip during the waking hours. It was programmed to record movements while the device was being worn."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||counts||Standard Error|Least Squares Mean
2671656|NCT01474772|Secondary|BPI-sf Score for Pain-Interference With Walking Ability at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference. The sub-score pain interference with walking ability was evaluated, as it was considered to be the most relevant in the context of this study.|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
2671657|NCT01474772|Secondary|BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain (0: no pain; 10: worst pain possible) at its worst, least, average, and now (current pain) on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
2671658|NCT01474772|Secondary|Brief Pain Inventory-Short Form (BPI-sf) Score for Pain-Severity Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain (0: no pain; 10: worst pain possible) at its worst, least, average, and now (current pain) on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
2671659|NCT01474772|Secondary|Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"The daily pain diary consisted of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).|||percentage of participants|||Number
2671660|NCT01474772|Secondary|Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"The daily pain diary consisted of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set. Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).|||percentage of participants|||Number
2671800|NCT01474200|Secondary|CLINICAL: Total Number of Days for Cardiovascular (CV) Rehospitalizations at 30 and 90 Days After Discharge|The total number of days spent in the hospital due to CV related events at 30 days and 90 days from hospital discharge.|Within 30 days and 90 days after hospital discharge||||Days|||Number
2671661|NCT01474772|Primary|DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period)|"The post-test DPN pain on walking NRS consisted of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their DPN pain in their legs and/or feet while walking during the 50-foot walk test by choosing the appropriate number between 0 and 10. The post-test DPN pain on walking NRS was completed by the participant using paper-pen administration immediately after completing the 50-foot walk test at the end of each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
2671662|NCT01474772|Post-Hoc|Average Weekly DPN Pain Based on a NRS (Baseline, 6 Weeks in Period 1, 2 Weeks Washout and 6 Weeks in Period 2)|"The daily pain diary consisted of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The longitudinal mean weekly DPN pain scores were defined as the mean of 7 daily diary pain ratings. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain."|Baseline, 6 weeks in Period 1, 2 weeks washout and 6 weeks in Period 2|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the ITT analysis (N: 203). Numbers of participants analyzed are provided in section Measured Values in brackets (N: Pregabalin, Placebo).|||units on a scale||Standard Deviation|Mean
2671663|NCT01474772|Primary|Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)|"The daily pain diary consisted of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via Interactive Voice Recognition System (IVRS). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain."|End of Period (includes both Visits 6 and 11)|All participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation were included in the Intent-to-Treat (ITT) analysis (N: 203). This was the primary analysis set.|||units on a scale||Standard Error|Least Squares Mean
2671664|NCT01474746|Secondary|Mullen Scales of Early Learning - Summary Age-equivalent Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores, percentile ranks, and age equivalents for each scale separately, as well as a cognitive T score sum and summary age-equivalent score to characterize overall early developmental ability. Summary age-equivalent scores range from 0 to 70 months, with lower scores indicating that a child's ability is at a level typical of younger ages, and higher scores indicating that a child's ability is at a level typical of older ages. The MSEL was administered at the baseline visit and at the 6-month follow-up visit, and mean summary age-equivalent scores at the 6-month follow-up visit for the placebo and treatment groups are shown here.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||months||Standard Deviation|Mean
2671665|NCT01474746|Secondary|Mullen Scales of Early Learning - Summary Age-equivalent Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores, percentile ranks, and age equivalents for each scale separately, as well as a cognitive T score sum and summary age-equivalent score to characterize overall early developmental ability. Summary age-equivalent scores range from 0 to 70 months, with lower scores indicating that a child's ability is at a level typical of younger ages, and higher scores indicating that a child's ability is at a level typical of older ages. The MSEL was administered at the baseline visit and at the 6-month follow-up visit, and mean baseline summary age-equivalent scores for the placebo and treatment groups are shown here.|At baseline visit||||months||Standard Deviation|Mean
2671666|NCT01474746|Secondary|Mullen Scales of Early Learning - Cognitive T Score Sum|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor (not administered because it was out of age range for most subjects), visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores for each scale separately. Each scale's T score has a range of 20 to 80, a mean of 50, and a standard deviation of 10, and the lower the T score, the lower the child's cognitive and developmental ability. Cognitive T score sum is the sum of the T scores for each scale administered; since 4 scales were administered, the sum's range is 80 to 320, with lower sums indicating lower overall ability. The MSEL was administered at the baseline and 6-month follow-up visits, and mean cognitive T score sums from the 6-month follow-up visit for the placebo and treatment groups are shown here.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||T scores||Standard Deviation|Mean
2671764|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Methotrexate (MTX)|"The percentage of participants who discontinued MTX treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.~Reason for discontinuation Other Intolerance = intolerance other than cytopenia or hepatic cytolysis."|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued MTX and with available data.|||percentage of participants|||Number
2671667|NCT01474746|Secondary|Mullen Scales of Early Learning - Cognitive T Score Sum|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor (not administered because it was out of age range for most subjects), visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale, the scoring software computes T scores for each scale separately. Each scale's T score has a range of 20 to 80, a mean of 50, and a standard deviation of 10, and the lower the T score, the lower the child's cognitive and developmental ability. Cognitive T score sum is the sum of the T scores for each scale administered; since 4 scales were administered, the sum's range is 80 to 320, with lower sums indicating lower overall ability. The MSEL was administered at the baseline visit and at the 6-month follow-up visit, and mean baseline cognitive T score sums for the placebo and treatment groups are shown here.|At baseline visit||||T scores||Standard Deviation|Mean
2671668|NCT01474746|Secondary|Mullen Scales of Early Learning - Fine Motor Age-equivalent Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean age-equivalent scores from the Fine Motor scale at the 6-month follow-up visit. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's fine motor skills are at a level typical of younger ages, and higher scores indicating that a child's fine motor skills are at a level typical of older ages.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||months||Standard Deviation|Mean
2671669|NCT01474746|Secondary|Mullen Scales of Early Learning - Fine Motor Age-equivalent Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean baseline age-equivalent scores from the Fine Motor scale. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's fine motor skills are at a level typical of younger ages, and higher scores indicating that a child's fine motor skills are at a level typical of older ages.|At baseline visit||||months||Standard Deviation|Mean
2671670|NCT01474746|Secondary|Mullen Scales of Early Learning - Fine Motor Raw Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean raw scores from the Fine Motor scale at the 6-month follow-up visit. This scale's raw scores range from 0 to 49. The lower the score on this scale, the weaker the child's fine motor skills; the higher the score, the greater the child's fine motor skills.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||units on a scale||Standard Deviation|Mean
2671671|NCT01474746|Secondary|Mullen Scales of Early Learning - Visual Reception Age-equivalent Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean age-equivalent scores from the Visual Reception scale at the 6-month follow-up visit. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's visual reception is at a level typical of younger ages, and higher scores indicating that a child's visual reception is at a level typical of older ages.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||months||Standard Deviation|Mean
2671672|NCT01474746|Secondary|Mullen Scales of Early Learning - Visual Reception Age-equivalent Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean baseline age-equivalent scores from the Visual Reception scale. This scale's age-equivalent scores for each of the five scales are calculated from the raw scores for each scale, using the MSEL Age Equivalents table. Age-equivalent scores for each scale range from 0 to 70 months, with lower scores indicating that a child's visual reception is at a level typical of younger ages, and higher scores indicating that a child's visual reception is at a level typical of older ages.|At baseline visit||||months||Standard Deviation|Mean
2671673|NCT01474746|Secondary|Mullen Scales of Early Learning - Visual Reception Raw Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean raw scores from the Visual Reception scale at the 6-month follow-up visit. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the child's ability for visual reception; the higher the score, the greater the ability for visual reception.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||units on a scale||Standard Deviation|Mean
2671687|NCT01474746|Secondary|Eye Tracking|There are several eye tracking measures, each intended to measure different outcomes including social gaze, social reciprocity, and attention. All stimuli are presented on a Tobii T120 binocular eye tracker monitor. The system consists of a high-resolution camera embedded in a 17-inch TFT monitor. Stimuli consist of sixty colored photographs of adult human face (equal numbers of males and females, different races and ethnicities) from the NimStim Face Stimulus Set, each showing a calm, happy, or fearful expression, and sixty scrambled versions of the face images. Shown here are the averaged response times (in seconds) to the presented stimuli, at the baseline visit.|At baseline visit|Data were collected and analyzed on those participants who were compliant with the eye tracking protocol: 13 in the placebo group, and 9 in the active group.|||seconds||Standard Deviation|Mean
2671674|NCT01474746|Secondary|Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score|The Vineland-II measures the personal and social skills of individuals from birth through adulthood. It was designed to assess handicapped and non-handicapped persons in their personal and social functioning and is appropriate for individuals of all ages. The Vineland-II is a survey that is administered to a parent or caregiver using a semi-structured interview format and is organized around four Behavior Domains: Communication, Daily Living Skills, Socialization, and Motor Skills. Each subtest is scored with a standard score X=100 ± 15 and summed to calculate the Adaptive Behavior Composite (ABC) using age-adjusted scoring tables. Reported here are the ABC mean standard scores for the placebo and treatment groups at the 6-month visit. The ABC ranges from 20 to 160 and indicates low (20-70), moderately low (70-85), adequate (85-115), moderately high (115-130), or high (130-160) overall adaptive functioning.|At six-month visit|This assessment was only introduced to the protocol partway through the trial. As such, only 20 subjects (10 placebo, 10 active) were administered the Vineland-2 at both baseline and follow-up visits.|||units on a scale||Standard Deviation|Mean
2671675|NCT01474746|Secondary|Sensory Profile - Sensation Seeking Subscale Raw Score|"The Sensory Profile is designed to measure sensory-related difficulties. This measure will be administered to the primary caregiver of each subject to measure the caregiver's sensory ability and its impact on the subject. Of the four subscales scored in the Sensory Profile, the Sensation Seeking subscale mean raw scores for the placebo and treatment groups are reported here. This subscale has a raw scores range from 0 to 95, with scores 0-6 indicating that the child is sensation seeking much less than others, 7-19 less than others, 20-47 just like the majority of others, 48-60 more than others, and 61-95 much more than others."|At six-month visit|The Sensory Profile assessment was not administered to any subjects at the follow-up visit due to revisions to the protocol.||||||
2671676|NCT01474746|Secondary|Sensory Processing Measure-Preschool (SPM-P) Social Participation: Raw Score|The Sensory Processing Measure - Preschool (SPM-P) is a questionnaire that was used to measure specific problems, including under- and over-responsiveness, sensory-seeking behavior, and perceptual problems in multiple environments (at home, at school, and in the community) for children aged 2 to 5 years old. The SPM-P provides norm-referenced standard scores for two higher level integrative functions (praxis and social participation) and five sensor sensory systems (visual, auditory, tactile, proprioceptive, and vestibular functioning). The SPM-P was administered to the caregiver at baseline and again at the 6-month follow-up visit. Reported here is the Social Participation subscale mean raw score from the 6-month visit, which ranges from 8 to 32. The lower the raw score, the more limited the child's level of social participation. The higher the score, the greater the child's level of social participation.|At six-month visit|2 subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent. 3 subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent. The SPM-P was removed from the protocol after the trial was initiated and was therefore not administered to 4 placebo and 3 treatment recipients at the 6-month visit.|||units on a scale||Standard Deviation|Mean
2671677|NCT01474746|Secondary|Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total Raw Score|The Preschool Language Scale-fifth edition (PLS-5) is designed to measure auditory comprehension (AC) and expressive communication (EC) for children birth to 7 years 11 months. The measure examines the child's attention, play, gestures, social communication, semantics, language structure, integrative language skills and emergent literacy skills. The PLS-5 has expanded coverage of early play behaviors, concepts, Theory of Mind, as well as emergent literacy skills. The PLS-5 yields norm-referenced scores including standard scores, percentile ranks and age equivalents for the AC and EC scales as well as for Total Language (TL). Raw score ranges are 0 to 65 in AC, 0 to 67 in EC, and therefore 0 to 132 in TL (calculated by summing AC+EC raw scores). The higher the scores, the greater the language ability. Shown here are the mean TL raw scores from the 6-month follow-up visit.|At six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||units on a scale||Standard Deviation|Mean
2671678|NCT01474746|Secondary|Eye Tracking|There are several eye tracking measures, each intended to measure different outcomes including social gaze, social reciprocity, and attention. All stimuli are presented on a Tobii T120 binocular eye tracker monitor. The system consists of a high-resolution camera embedded in a 17-inch TFT monitor. Stimuli consist of sixty colored photographs of adult human face (equal numbers of males and females, different races and ethnicities) from the NimStim Face Stimulus Set, each showing a calm, happy, or fearful expression, and sixty scrambled versions of the face images. Shown here are the averaged response times (in seconds) to the presented stimuli, at the 6-month follow-up visit.|At six-month visit|Data were collected and analyzed on those participants who were compliant with the eye tracking protocol: 13 in the placebo group, and 9 in the active group.|||seconds||Standard Deviation|Mean
2671679|NCT01474746|Secondary|The Visual Analog Scale|"The Visual Analog Scale will be used to measure the severity of three specific behavioral symptoms chosen by the caregiver(s). Parents mark on a visual line measuring 10 cm with worst behavior at 0 cm and best behavior at 10 cm. The parents choose two key behaviors that they want to target for this trial (e.g., aggression, hyperarousal, anxiety, hyperactivity) and the third target measurement is language/communication. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the 6-month visit. The calculated distance in cm between the baseline and 6-month visit marks thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the worst behavior side, at the 6-month visit. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm."|At six-month visit|"Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent. An additional subject from the sertraline arm was not administered this measure at the 6-month visit due to staff oversight.~Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent"|||units on a scale||Standard Deviation|Mean
2671709|NCT01474512|Secondary|Percentage of Participants With Anti-ixekizumab Antibodies|Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.|Baseline through Week 12|All randomized participants who received at least 1 dose of study drug and had evaluable data.|||percentage of participants|||Number
2671680|NCT01474746|Secondary|The Autism Diagnostic Observation Schedule (ADOS-2)|The Autism Diagnostic Observation Schedule (ADOS-2) assesses and diagnoses autism spectrum disorder. This test was administered at baseline and at the six-month follow-up visit. The choice to administer Module 1 or Module 2 depends on the verbal ability of each subject: Module 1 is used for children who are 31 months and older and/or who do not consistently use phrase speech, and Module 2 is used for children of any age who use phrase speech but are not verbally fluent. The scoring algorithm gives an overall total, which ranges from 0 to 28. The higher the score, the higher the level of autism-related symptoms. The overall total ranges from 0 to 28. On Module 1, for children with few to no words, scores at 11 and above indicate autism spectrum; for children with some words, the cutoff is scores 8 and above. On Module 2, the cutoff for autism spectrum is 7 or above for kids under 5 years, and 8 or above for those 5 years and older.|At six month visit|The ADOS was not administered to all subjects at the six-month visit due to the PI's decision to remove this assessment from the protocol partway through the study; due to staff oversight, however, the ADOS remained listed in the protocol. Also, 2 sertraline and 3 placebo subjects discontinued and were thus administered no follow-up ADOS.|||units on a scale||Standard Deviation|Mean
2671681|NCT01474746|Secondary|Mullen Scales of Early Learning - Fine Motor Raw Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean raw scores from the Fine Motor scale at the baseline visit. This scale's raw scores range from 0 to 49. The lower the score on this scale, the weaker the child's fine motor skills; the higher the score, the greater the child's fine motor skills.|At baseline visit||||units on a scale||Standard Deviation|Mean
2671682|NCT01474746|Secondary|Mullen Scales of Early Learning - Visual Reception Raw Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the mean baseline raw scores from the Visual Reception scale. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the child's ability for visual reception; the higher the score, the greater the ability for visual reception.|At baseline visit||||units on a scale||Standard Deviation|Mean
2671683|NCT01474746|Secondary|Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) - Adaptive Behavior Composite Standard Score|The Vineland-II measures the personal and social skills of individuals from birth through adulthood. It was designed to assess handicapped and non-handicapped persons in their personal and social functioning and is appropriate for individuals of all ages. The Vineland-II is a survey that is administered to a parent or caregiver using a semi-structured interview format and is organized around four Behavior Domains: Communication, Daily Living Skills, Socialization, and Motor Skills. Each subtest is scored with a standard score X=100 ± 15 and summed to calculate the Adaptive Behavior Composite (ABC) using age-adjusted scoring tables. Reported here are the ABC mean standard scores for the placebo and treatment groups baseline. The ABC ranges from 20 to 160 and indicates low (20-70), moderately low (70-85), adequate (85-115), moderately high (115-130), or high (130-160) overall adaptive functioning.|At baseline visit|This assessment was introduced to the protocol partway through the study, and therefore there were only 20 subjects (10 placebo and 10 active) who were administered the Vineland-II at both their baseline and follow-up visits.|||units on a scale||Standard Deviation|Mean
2671684|NCT01474746|Secondary|Sensory Profile - Sensation Seeking Subscale Raw Score|"The Sensory Profile is designed to measure sensory-related difficulties. This measure will be administered to the primary caregiver of each subject to measure the caregiver's sensory ability and its impact on the subject. Of the four subscales scored in the Sensory Profile, the Sensation Seeking subscale mean raw scores for the placebo and treatment groups are reported here. This subscale has a raw scores range from 0 to 95, with scores 0-6 indicating that the child is sensation seeking much less than others, 7-19 less than others, 20-47 just like the majority of others, 48-60 more than others, and 61-95 much more than others."|At baseline visit|The Sensory Profile was not administered to all subjects at baseline due to the PI's decision to remove this assessment from the protocol partway through the study; due to staff oversight, however, this assessment remained listed among the measures in the protocol.|||units on a scale||Standard Deviation|Mean
2671685|NCT01474746|Secondary|Sensory Processing Measure - Preschool (SPM-P) Social Participation: Raw Score|The Sensory Processing Measure - Preschool (SPM-P) is a questionnaire that was used to measure specific problems, including under- and over-responsiveness, sensory-seeking behavior, and perceptual problems in multiple environments (at home, at school, and in the community) for children aged 2 to 5 years old. The SPM-P provides norm-referenced standard scores for two higher level integrative functions (praxis and social participation) and five sensor sensory systems (visual, auditory, tactile, proprioceptive, and vestibular functioning). Reported here is the Social Participation subscale mean raw score, which ranges from 8 to 32. The lower the raw score, the more limited the child's level of social participation. The higher the score, the greater the child's level of social participation.|At baseline visit|The SPM-P was removed from the protocol after the trial was initiated and was therefore not administered to 1 subject in the active treatment group at baseline.|||units on a scale||Standard Deviation|Mean
2671686|NCT01474746|Secondary|Preschool Language Scale-fifth Edition (PLS-5): AC+EC Total Raw Score|The Preschool Language Scale-fifth edition (PLS-5) is designed to measure auditory comprehension (AC) and expressive communication (EC) for children birth to 7 years 11 months. The measure examines the child's attention, play, gestures, social communication, semantics, language structure, integrative language skills and emergent literacy skills. The PLS-5 has expanded coverage of early play behaviors, concepts, Theory of Mind, as well as emergent literacy skills. The PLS-5 yields norm-referenced scores including standard scores, percentile ranks and age equivalents for the AC and EC scales as well as for Total Language (TL). Raw score ranges are 0 to 65 in AC, 0 to 67 in EC, and therefore 0 to 132 in TL (calculated by summing AC+EC raw scores). The higher the scores, the greater the language ability. Shown here are the mean TL raw scores from the baseline visit.|At baseline visit||||units on a scale||Standard Deviation|Mean
2671710|NCT01474512|Secondary|Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss)||Weeks 12: Day 84 and Week 24: Day 168|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had Ctrough ss results at specified time points where the concentration met the definition of being a trough concentration.|||micrograms/milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2671688|NCT01474746|Secondary|Visual Analog Scale|"The Visual Analog Scale will be used to measure the severity of three specific behavioral symptoms chosen by the caregiver(s). Parents mark on a visual line measuring 10 cm with worst behavior at 0 cm and best behavior at 10 cm. The parents choose two key behaviors that they want to target for this trial (e.g., aggression, hyperarousal, anxiety, hyperactivity) and the third target measurement is language/communication. For each behavior the caregiver is instructed to mark their impression of the behavior at baseline visit and again at the 6-month visit. The calculated distance in cm between the baseline and 6-month visit marks thereby demonstrates whether each behavior improved, worsened, or stayed the same during the study, and by how much. Shown here is the mean distance in cm from the worst behavior side, at baseline. The smaller the value, the worse the behavior. The range is minimum 0 cm to maximum 10 cm."|At baseline visit||||centimeters||Standard Deviation|Mean
2671689|NCT01474746|Secondary|Autism Diagnostic Observation Schedule|The Autism Diagnostic Observation Schedule (ADOS-2) assesses and diagnoses autism spectrum disorder. This test was administered at baseline and at the six-month follow-up visit. The choice to administer Module 1 or Module 2 depends on the verbal ability of each subject: Module 1 is used for children who are 31 months and older and/or who do not consistently use phrase speech, and Module 2 is used for children of any age who use phrase speech but are not verbally fluent. The scoring algorithm gives an overall total, which ranges from 0 to 28. The higher the score, the higher the level of autism-related symptoms. The overall total ranges from 0 to 28. On Module 1, for children with few to no words, scores at 11 and above indicate autism spectrum; for children with some words, the cutoff is scores 8 and above. On Module 2, the cutoff for autism spectrum is 7 or above for kids under 5 years, and 8 or above for those 5 years and older.|At baseline visit|The ADOS was not administered to all subjects at baseline due to the PI's decision to remove this assessment from the protocol partway through the study; due to staff oversight, however, this assessment remained listed among the measures in the protocol.|||units on a scale||Standard Deviation|Mean
2671690|NCT01474746|Primary|Change in Mullen Scales of Early Learning - Expressive Language Standard T Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language and expressive language. Based on the raw score obtained by the participant in each scale the scoring software computes T scores, percentile ranks, and age equivalents for each scale separately. Shown here are the baseline and 6-month follow-up T scores from the expressive language scale. T scores have a range of 20 to 80, a mean of 50, and a standard deviation of 10. Any child scoring at or below 1.5 standard deviations below the average is considered presenting significant delays. The lower the T score, the worse the outcome. The MSEL was administered at the baseline visit and at the 6-month follow-up visit.|From baseline visit to six-month visit|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||T scores||Standard Deviation|Mean
2671691|NCT01474746|Primary|Clinical Global Impression - Improvement|The Clinical Global Impression - Improvement (CGI-I) is used to measure the overall behavioral change of an individual and their therapeutic response. The CGI-I is a 3-item observer-rated scale administered by the physician to the caregiver, who assesses improvement using a 7-point scale: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; and 7 = Very much worse. Therefore, the lower the score, the greater the behavioral improvement as rated by the caregiver. Shown here are the CGI-I mean scores from the 6-month follow-up visit.|6-month follow-up visit score|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||units on a scale||Standard Deviation|Mean
2671692|NCT01474746|Primary|Change in Mullen Scales of Early Learning - Expressive Language Raw Score|The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the baseline and 6-month follow-up raw scores from the expressive language scale. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the ability; the higher the score, the greater the ability. The MSEL was administered at the baseline visit and at the 6-month follow-up visit.|From baseline visit to six-month visit.|Two subjects from the sertraline arm discontinued - 1 lost to follow up, 1 withdrew consent Three subjects from the placebo arm discontinued - 1 lost to follow up, 2 withdrew consent|||units on a scale||Standard Deviation|Mean
2671693|NCT01474681|Secondary|Disease Free Survival (DFS) Within One Year|Number of participants with Disease Free Survival (DFS) within one year. Patients are considered to have achieved DFS or relapse-free survival if they had not experienced either relapse or death (of any cause)|Month 12|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.|||participants|||Number
2671694|NCT01474681|Secondary|Overall Survival (OS) Within One Year|Number of participants with Overall survival (OS) within one year|Month 12|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.|||participants|||Number
2671695|NCT01474681|Secondary|Incidence of Relapse Within One Year|Number of participants with Incidence of relapse within one year|Month 12|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.|||participants|||Number
2671696|NCT01474681|Secondary|Incidence of Acute Graft Versus Host Disease (aGVHD) Within 100 Days and Chronic Graft Versus Host Disease (cGVHD) Within 1 Year|Number of participants with incidence of Acute Graft Versus Host Disease (aGVHD) within 100 days and Chronic Graft Versus Host Disease (cGVHD) within 1 year|Day 100 and Monnth 12|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.|||participants|||Number
2671697|NCT01474681|Secondary|Incidence of Transplant Related Mortality (TRM) Within 100 Days and One Year|Number of participants with incidence of transplant related mortality (TRM) within 100 days and one year|Day 100 and Month 12|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.|||participants|||Number
2671797|NCT01474200|Secondary|CLINICAL: Days Alive and Out of Hospital at 30 and 90 Days After Discharge|Number of days patients were alive and out of the hospital.|Within 30 and 90 days after hospital discharge||||Days||Standard Deviation|Mean
2671698|NCT01474681|Secondary|Frequency of Expanded Unit Predominance at Day 100 (DUCBT Recipients Only)|Frequency of expanded unit predominance at day 100 (DUCBT recipients only) unit predominance was assessed by differences in microsatellite patterns between the recipient, HSC835 and the unmanipulated cord blood unit. Evaluation of sorted CD15-positive/CD33-positive myeloid and CD3-positive T cells in the peripheral blood, revealed three patterns: predominance of HSC835, Mixed dominance an unique chimerism pattern was observed with the CD15/CD33 population predominantly derived from HSC835 and the CD3 population almost exclusively derived from the unmanipulated unit, and predominance of the unmanipulated unit|Day 100|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.|||participants|||Number
2671699|NCT01474681|Secondary|Incidence of Platelet Recovery Within Six Months|Incidence of platelet recovery within six months. Number of participants recovering platelet to ≥50,000 × 109/L for at least one week without transfusion in the prior 7 days to the first measurement.|6 months|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.|||participants|||Number
2671700|NCT01474681|Secondary|Incidence of Neutrophil Recovery Within 42 Days|Neutrophil recovery (engraftment) is defined as the first of three consecutive days with ANC > 0.5 x 109/L which occurred for all patients before 42 days post transplant.|42 days|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.|||participants|||Number
2671701|NCT01474681|Primary|Safety and Tolerability of HSC835 for Clinical Use Were Measured by Infusional Toxicity (Within First 48 Hours After Transplant) and Absence of Graft Failure After 32 Days in Excess of That Currently Observed With UCBT.|The safety and tolerability of HSC835 for clinical use were measured by infusional toxicity and absence of graft failure in excess of that currently observed with UCBT. Infusional toxicity - AE from transplant until first 48 hours. Administration of the HSC835 expanded CD34-positive cell product, infused over a period of approximately 15 minutes may theoretically cause adverse reactions based on hemodynamic effects, the release of factors like cytokines through administration into the systemic circulation, or acute hypersensitivity, among others.|32 days|Safety Analysis Set (SAS) comprising all patients who were transplanted is used for analysis of all demographic, safety and engraftment outputs.|||participants|||Number
2671702|NCT01474590|Primary|The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements|"Overall success is reached when the 2 following criteria are fulfilled :~Overall efficacy: reduction of at least 75% of number of nodules at the end of treatment~Safe treatment: Absence of any listed safety issues"|20 weeks||||count of participants|||Number
2671703|NCT01474551|Primary|Overall Objective Response|The Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 will be used to determine treatment response. In order to be considered evaluable for response, a patient must have completed at least 1 cycle of therapy. Patients who do not complete a cycle of therapy can be replaced.|2 years||||participants|||Number
2671704|NCT01474538|Secondary|Percentage of Participants With Hypoglycemic Events|A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)]. The percentage of participants is the total number of participants experiencing hypoglycemic events divided by number of participants in the treatment arm multiplied by 100.|Baseline through 16 weeks of each treatment (Periods 1 and 2)|All randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the treatment they received.|||percentage of participants|||Number
2671705|NCT01474538|Secondary|Change From Baseline in Weight|Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%), baseline weight and participants.|Baseline, Week 16 of treatment Periods 1 and 2|All randomized participants who received at least 1 dose of study drug and had weight measured at baseline and Week 16 of Treatment Period 1 or 2. Participants were analyzed based on the treatment they received.|||kilograms (kg)||Standard Error|Least Squares Mean
2671706|NCT01474538|Secondary|Rate of Hypoglycemic Events Per 30 Days|A hypoglycemic episode is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose concentration of ≤70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)]. Least Squares (LS) means were adjusted for treatment, period, sequence, baseline hypoglycemic event rate, thiazolidinedione use (Yes/No) and baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%).|Baseline through 16 weeks of each treatment (Periods 1 and 2)|All randomized participants who received at least 1 dose of study drug. Participants were analyzed based on the treatment they received.|||hypoglycemic events per 30 days||Standard Error|Least Squares Mean
2671707|NCT01474538|Secondary|Total Daily Insulin Dose|Total daily insulin dose was the average of the last 3 days total insulin dose immediately prior to the Week 16 (endpoint) visit of each treatment period. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline Hemoglobin A1c (HbA1c) (>8% or ≤8%) and participants.|Week 16 of each treatment (Periods 1 and 2)|All randomized participants who received at least 1 dose of study drug and had total daily insulin dose recorded during Treatment Period (TP) 1 or 2. If endpoint data was missing for a specific TP, last observation carried forward (LOCF) method was implemented for that respective TP. Participants were analyzed based on the treatment they received.|||units of insulin||Standard Error|Least Squares Mean
2671708|NCT01474538|Primary|Glycosylated Hemoglobin A1C (HbA1c) at Endpoint|Hemoglobin A1c (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over the last 8-12 weeks. Least Squares (LS) means were adjusted for treatment, period, sequence, thiazolidinedione use (Yes/No), baseline HbA1c (>8% or ≤8%) and participants.|After 16 weeks of each treatment (Periods1 and 2)|All randomized participants who received at least 1 dose of study drug and had HbA1c measured at Week 16 of treatment Period 1 or 2. Participants were analyzed based on the treatment they received.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2671728|NCT01474434|Secondary|Interleukin-6 (IL-6) Level (Part A)||Baseline, day 4 and day 5, of each treatment period|The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.||||||
2673496|NCT01461551|Secondary|Intensive Care Unit Staying Days||participants will stay in intensive care unit after surgery, an expected average of 2 days|||||||
2671711|NCT01474512|Secondary|Percentage of Participants Achieving Palmoplantar PASI (PPASI) of ≥50% (PPASI50), ≥75% (PPASI75), or 100% (PPASI100) Improvement|The Palmoplantar PASI is a composite score derived from the sum of scores for erythema, induration, and desquamation [scores range from 0 (none) to 4 (very severe) for each] multiplied by the score for the extent of palm and sole area involvement [scores range from 0 (0%) to 6 (90 to100%)], with a total scores range from 0 to 72. Participants achieving PPASI50, PPASI75 or PASI100 were defined as having an improvement of at least 50%, 90%, or of 100%, respectively, in the PPASI scores compared to baseline.|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had palmoplantar Ps at baseline.|||percentage of participants|||Number
2671712|NCT01474512|Secondary|Change From Baseline in Patient's Global Assessment of Disease Severity (PatGA)|"The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis today by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). LS mean change from baseline calculated using MMRM."|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with at least 1 post-baseline PatGA measurement.|||units on a scale||Standard Error|Least Squares Mean
2671713|NCT01474512|Secondary|Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36) and Physical Component Summary (PCS) and Mental Component Summary (MCS)|The SF-36 is a self-reported instrument that measures the participant's health status during the previous 7 days. It comprises 36-items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped in the PCS and MCS scores. Scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean change from baseline was calculated using ANCOVA.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and with results at the specified time points, LOCF.|||units on a scale||Standard Error|Least Squares Mean
2671714|NCT01474512|Secondary|Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16)|QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. LS mean change from baseline was calculated using ANCOVA.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at the specified time points, LOCF.|||units on a scale||Standard Error|Least Squares Mean
2671715|NCT01474512|Secondary|Change From Baseline in All Scores of the Work Productivity Activity Impairment Questionnaire-Psoriasis (WPAI-PSO) Quality of Life and Outcome Assessments. Measures: Participant Reported Outcomes (PRO)|WPAI-PSO is a participant administered, 6-item instrument used to assess the impact of Ps on the productivity impairment within the past 7 days. WPAI-PSO has 4 domains: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score, and impairment in daily activities performed outside of work. Four scores are derived as percentages: absenteeism, presenteeism (reduced productivity while at work), overall work impairment (absenteeism and presenteeism), and impairment in activities performed outside of work. Percentage is calculated as: each score * 100 with greater scores indicating greater impairment. LS mean change from baseline was calculated using analysis of covariance (ANCOVA).|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned, and had results at specified time points, last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2671716|NCT01474512|Secondary|Change From Baseline in Psoriasis Scalp Severity Index (PSSI)|The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity. LS mean change from baseline was calculated using MMRM.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had scalp Ps at baseline.|||units on a scale||Standard Error|Least Squares Mean
2671717|NCT01474512|Secondary|Percent of Body Surface Area (BSA) Involvement of Ps|BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), where 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb). Total BSA is the sum of handprints from the affected areas. LS mean change from baseline was calculated using MMRM.|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had at least 1 post-baseline BSA measurement.|||percentage of body surface||Standard Error|Least Squares Mean
2671718|NCT01474512|Secondary|Change From Baseline in Nail Psoriasis Severity Index (NAPSI)|The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all fingernails equals the total NAPSI score with a range from 0 to 80 with higher scores indicating more severe psoriasis. LS mean change from baseline was calculated using MMRM.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had fingernail Ps at baseline.|||units on a scale||Standard Error|Least Squares Mean
2671719|NCT01474512|Secondary|Change From Baseline in Dermatology-Specific Quality of Life Index (DLQI) Score|"DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered (not relevant) responses were scored as 0. Total scores range from 0 to 30, with higher score indicating greater quality of life is impairment. A 5-point change from baseline is considered clinically relevant. Least squares (LS) mean change from baseline was calculated using mixed model repeated measures (MMRM)."|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and who had at least 1 post-baseline DLQI measurement.|||units on a scale||Standard Error|Least Squares Mean
2671720|NCT01474512|Secondary|Percentage of Participants With Itch Numeric Rating Scale (Itch NRS) Score ≥4 Point Reduction From Baseline|The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.|Baseline, Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned; and had an Itch NRS score ≥4 at baseline. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.|||percentage of participants|||Number
2671721|NCT01474512|Secondary|Percentage of Participants Maintaining sPGA 0 or 1 After Re-Randomization at Start of Maintenance Dosing Period|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 60|Maintenance Period Primary Population (MPPP): all randomized participants from Period 2 who achieved sPGA (0, 1), were re-randomized at Week 12 and who received at least 1 dose of study treatment Period 3. Participants did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.|||percentage of participants|||Number
2671722|NCT01474512|Secondary|Percentage of Participants Achieving PASI 90% (PASI90) or 100% (PASI100) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: PASI)|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI90 or PASI100 were defined as having an improvement of ≥90% or of 100% respectively in PASI scores compared to baseline.|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.|||percentage of participants|||Number
2671723|NCT01474512|Secondary|Percentage of Participants Achieving an sPGA of 0 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)|The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they are assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.|||percentage of participants|||Number
2671724|NCT01474512|Primary|Percentage of Participants Achieving ≥75% Improvement in Ps Area and Severity Index (PASI75) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: PASI)|The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants achieving PASI75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.|Week 12|ITT Population: all randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.|||percentage of participants|||Number
2671725|NCT01474512|Primary|Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA)|"The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline."|Week 12|Intent to Treat (ITT) Population: all randomized participants analyzed according to the treatment to which they were assigned. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.|||percentage of participants|||Number
2671726|NCT01474434|Secondary|Adiponectin Level ( Part B)||Part B; Baseline, day 15, day 43 and day 85|The study was terminated based on the interim analysis on Part A, cohort 1 after patients completed Part A. Part B of the study was not commenced.||||||
2671727|NCT01474434|Secondary|C-reactive Protein (CRP) Level (Part A)||Baseline, day 4 and day 5, of each treatment period|The study was terminated based on the interim analysis on Part A, Cohort 1 after patients completed Part A. The analysis of this assessment was not part of interim analysis; hence it is not done.||||||
2671731|NCT01474434|Secondary|Postprandial Triglycerides (Part A, Cohort 2)|For both each treatment period, postprandial triglycerides were measured on Day 5 i.e. on 0 hour (before breakfast), two hours and four hours post high-fat breakfast. Results are from an ANCOVA model on change from baseline in the log domain with log(baseline), treatment, sequence and period as fixed effects. Baseline is the Day -1 value within period. The data reported is ratio of geometric mean between post-treatment and baseline data.|0 hour (before breakfast), 2 and 4 hours post high-fat breakfast on day 5|The efficacy analysis set included all patients who took more than 80% of study medication as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of the primary efficacy variables at both baseline and post treatment visits.|||ratio||Standard Error|Geometric Mean
2671732|NCT01474434|Secondary|Postprandial Triglycerides (Part A, Cohort 1)|For both each treatment period, postprandial triglycerides were measured on Day 5 i.e. on 0 hour(before breakfast), two hours and four hours post high-fat breakfast. Results are from an ANCOVA model on change from baseline in the log domain with log(baseline), treatment, sequence and period as fixed effects. Baseline is the Day -1 value within period. The data reported is ratio of geometric mean between post-treatment and baseline data.|0 hour (before breakfast), 2 and 4 hours post high-fat breakfast on day 5|The efficacy analysis set included all patients who took more than 80% of study medication as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of the primary efficacy variables at both baseline and post treatment visits.|||ratio||Standard Error|Geometric Mean
2671733|NCT01474434|Secondary|Number of Participants With Adverse Events (Part A, Cohort 2)||approximately 40 days|The safety analysis set included all patients who received at least one dose of study drug.|||Participants|||Number
2671734|NCT01474434|Secondary|Number of Participants With Adverse Events (Part A, Cohort 1)||approximately 40 days|The safety analysis set included all patients who received at least one dose of study drug.|||Participants|||Number
2671735|NCT01474434|Primary|Aortic Plaque Inflammation (Part B)|This endpoint was palnned for analysis on Part B patients which was never started becasue study got terminated on Part A interim analysis.|Baseline and on treatment day 85 +/- 3 days|The study was terminated based on the interim analysis after patients completed Part A. Part B of the study was never started.||||||
2671736|NCT01474434|Primary|Time to Onset of Exercise-induced Ischemia(Part A, Cohort 1)|Exercise-induced ischemia was defined as the new development of horizontal or down-sloping ST-segment depression (≥ 1mm at 60 milliseconds after the J point) versus baseline tracings.|Baseline and on day 5 of each of the two treatment periods|The study was terminated based on the interim analysis after patients completed Part A. This outcome measure was not part of interim analysis; hence it is not done. .||||||
2671737|NCT01474434|Primary|Time to Onset of Angina (Part A, Cohort 1)|Time to onset of angina was defined as the elapsed time between the start of exercise and the onset of anginal chest pain as reported by the patient and recorded by the performing investigator.|Baseline and on day 5 of each of the two treatment periods|The study was terminated based on the interim analysis after patients completed Part A. This outcome measure was not part of interim analysis; hence it is not done. .||||||
2671738|NCT01474434|Primary|Change From Baseline in Total Exercise Duration (Part A, Cohort 1)|Total exercise duration was the elapsed time between the start of exercise and termination of exercise for severe angina, dyspnea or extreme fatigue. This primary endpoint was only for Part A, Cohort 1 patients.|Baseline and on day 5 of each of the two treatment periods|Efficacy analysis set- Patients who took > 80% of study drug as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of total exercise duration at both baseline and post-treatment visits. Patients who had no baseline or post-treatment exercise duration data in 1 of 2 periods were excluded from the analysis.|||minute||Standard Error|Least Squares Mean
2671739|NCT01474434|Primary|Change From Baseline in Myocardial Perfusion Reserve Index (MPRi) Overall Mean (Part A, Cohort 1)|MPRi (myocardial perfusion reserve index) is a measure of coronary microvascular function. Myocardial perfusion scans using 0.05 mmol/kg of gadolinium contrast were acquired at rest and under stress (pharmacological stress induced with adenosine 140 μg/kg/min for three minutes). An independent central reader performed the cardiac image analysis of all time points including the calculation of the myocardial perfusion reserve index from the ratio of the global stress myocardial blood flow divided by the resting blood flow values. Higher/increased index indicates improved flow/better outcome. This primary endpoint was only for Part A, Cohort 1 patients.|Baseline, and on day 5 of each of the two treatment periods|Efficacy analysis set - Patients who took > 80% of study drug as assessed by drug accountability, had no major protocol deviations, and had a valid assessment of MPRi at both baseline and post-treatment visits. Patients who had no baseline or post-treatment MPRi data in 1 of 2 periods were excluded from the analysis.|||myocardial perfusion reserve index||Standard Error|Least Squares Mean
2671740|NCT01474317|Secondary|Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction|After reading the instructions for use, and without assistance from the study staff, subjects use the BGMS to utilize some of the additional features of the system. Study staff documents Yes or No 'Did the subject complete the task successfully?'|1 hour||||participants|||Number
2671741|NCT01474317|Secondary|Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI venous plasma results are used to calculate the number of BGMS results within +/- 5to15mg/dL (<75mg/dL YSI venous plasma) or +/- 5to20% (>=75mg/dL YSI venous plasma).|1 hour|Venipuncture was unsuccessful for one subject. 223 (224-1) venous blood test results were analyzed.|||percentage of meter test results|||Number
2671742|NCT01474317|Secondary|Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma).|1 hour|Blood data for 3 subjects were not evaluable because time defined in protocol was exceeded between meter test and blood sample preparation for reference method. 221 (224-3) blood test results were analyzed.|||percentage of meter test results|||Number
2671743|NCT01474317|Primary|Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 5to15mg/dL (<100mg/dL YSI capillary plasma) or +/- 5to15% (>=100mg/dL YSI capillary plasma). Site staff tested in parallel after subjects.|1 hour|Blood data for three subjects were not evaluable because time defined in protocol was exceeded between meter test and blood sample preparation for reference method. 221 (224-3) blood test results were analyzed.|||percentage of meter test results|||Number
2671744|NCT01474291|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding if accompanied by clinical symptoms, results in a change in study treatment, results in a medical intervention or a change in concomitant therapy or clinically significant in the investigator's judgment), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to 30 months|Safety population, defined as participants who received at least one infusion of tocilizumab.|||percentage of participants|||Number
2671745|NCT01474291|Secondary|Percentage of Participants With Acceptable Health State Assessed by the Patient Acceptable Symptom State (PASS) Questionnaire.|"Participants were asked: If you were to remain in the same condition for the next few months as you have been over the last 8 days, would this be 1) acceptable, 2) unacceptable? The percentage of participants who responded acceptable at each time point is presented."|Baseline; Month 6; Month 12|Participants in the Efficacy population who received at least one infusion of tocilizumab, who met all inclusion and exclusion criteria, and with available data at the respective time point.|||percentage of participants|||Number
2671746|NCT01474291|Secondary|Mean Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score|The RAID questionnaire is a participant-reported outcome measure evaluating the impact of rheumatoid arthritis on participant quality of life. This composite index score ranges from 0 (best) to 10 (worst) and includes questions regarding 7 domains (pain, functional disability assessment, fatigue, sleep, physical well-being, emotional well-being, coping). A decrease in score corresponds to improvement in participant-assessed health state.|Baseline; Month 6, Month 12|Participants in the Efficacy population who received at least one infusion of tocilizumab, who met all inclusion and exclusion criteria, and with available data at the respective time point.|||units on a scale||Standard Deviation|Mean
2671747|NCT01474291|Secondary|Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The HAQ-DI is a participant-reported assessment of ability to perform daily living activities. This composite index score ranges from 0 (normal) to 3 (total functional disability) and includes questions regarding 8 domains (dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week). A decrease in score corresponds to improvement in participant-assessed health state.|Baseline; Month 6; Month 12|Participants in the Efficacy population who received at least one infusion of tocilizumab, who met all inclusion and exclusion criteria, and with available data at the respective time point.|||units on a scale||Standard Deviation|Mean
2671748|NCT01474291|Secondary|Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Month 12|"EULAR response was categorized as good or moderate response and was calculated as the difference between DAS28-ESR scores at baseline and Month 12. DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity.~If diminution from baseline >1.2 and score ≤3.2 at Month 12 = good response~If diminution from baseline >1.2 and score >3.2 at Month 12 = moderate response~If diminution from baseline >0.6 and ≤1.2, and score ≤5.1 at Month 12 = moderate response~If diminution from baseline >0.6 and ≤1.2, and score >5.1 at Month 12 = non-response~If diminution from baseline ≤1.2 at Month 12 = non-response~Participants with missing data were considered as non-response"|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
2671749|NCT01474291|Secondary|Percentage of Participants With American College or Rheumatology (ACR)20, ACR50, and ACR70 at Month 12|ACR20/50/70 response was calculated as improvement (from baseline) of at least 20/50/70% (respectively) of tender and of swollen joints, and improvement from baseline of least 20/50/70% (respectively) in at least 3 of the 5 following parameters: participant's pain assessment, patient's global assessment of disease activity, physician's global assessment of disease activity, health assessment questionnaire disability index (HAQ-DI) score, and ESR (mm/hour) or CRP (mg/L). Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
2671750|NCT01474291|Secondary|Percentage of Participants With SDAI Remission at Month 12|SDAI was calculated from the number of swollen joints and tender joints using the 28-joint count, CRP (mg/L), and the patient's global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity. A score of ≤3.3 was considered to be SDAI remission. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
2671751|NCT01474291|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) LDA at Month 12|SDAI was calculated from the number of swollen joints and tender joints using the 28-joint count, C-reactive protein (CRP) (milligrams per liter (mg/L)) per , and the patient's global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity. A score of ≤11 was considered to be SDAI LDA. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
2671752|NCT01474291|Secondary|Percentage of Participants With CDAI Remission at Month 12|CDAI was calculated from the number of swollen joints and tender joints using the 28-joint count and the patient's global assessment of disease activity and physician's global assessment of disease activity; CDAI scores range from 0 to 76, where lower scores indicate less disease activity. A score of ≤2.8 was considered to be CDAI remission. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
2671753|NCT01474291|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) LDA at Month 12|CDAI was calculated from the number of swollen joints and tender joints using the 28-joint count and the patient's global assessment of disease activity and physician's global assessment of disease activity; CDAI scores range from 0 to 76, where lower scores indicate less disease activity. A score of ≤10 was considered to be CDAI LDA. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
2671754|NCT01474291|Secondary|Percentage of Participants With DAS28-ESR Remission at Month 12|DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity. A score of <2.6 was considered to be DAS28-ESR remission. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
2671755|NCT01474291|Secondary|Percentage of Participants in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Low Disease Activity (LDA) at Month 12|DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity. A score of ≤3.2 was considered to be DAS28-ESR LDA. Participants with missing data were considered to have failed to achieve the outcome.|Month 12|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
2671756|NCT01474291|Secondary|Percentage of Participants With at Least One csDMARD Intensification During the Study|csDMARD intensification was defined as an addition of a csDMARD without suppression of other csDMARD, dose increase of a csDMARD, switch (addition and suppression) of a csDMARD without intolerance, biological abnormality or symptom improvement to the suppressed csDMARD, or modification of the MTX administration route (from oral route to intramuscular/subcutaneous) with dose increase or maintenance.|Up to 30 months|Participants in Efficacy population who received at least 1 infusion of tocilizumab, who met all inclusion/exclusion criteria, and with no permanent discontinuation of tocilizumab treatment over the study period. For efficacy criteria with response/non response values, participants with non-evaluable response were considered as non-responders.|||percentage of participants|||Number
2671757|NCT01474291|Secondary|Percentage of Participants With No Modification of Tocilizumab Treatment Over the Study Period|The percentage of participants with no modifications (dose modification or discontinuation) is presented.|Up to 30 months|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
2671758|NCT01474291|Secondary|Percentage of Participants Who Received Tocilizumab Infusions Over the Study Period|The percentage of participants who received infusions is presented by category of total infusions received over the study period.|Up to 13.4 months|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||percentage of participants|||Number
2671759|NCT01474291|Secondary|Mean Number of Tocilizumab Infusions Over the Study Period||Up to 30 months|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||infusions||Standard Deviation|Mean
2671760|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Unspecified Conventional Synthetic Disease-modifying Antirheumatic Drugs (csDMARDs)|The percentage of participants who discontinued treatment with unspecified csDMARDs prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued treatment with unspecified csDMARDs and with available data.|||percentage of participants|||Number
2671761|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Hydroxychloroquine|The percentage of participants who discontinued hydroxychloroquine treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued hydroxychloroquine and with available data.|||percentage of participants|||Number
2671762|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Sulfasalazine|The percentage of participants who discontinued sulfasalazine treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued sulfasalazine and with available data.|||percentage of participants|||Number
2671763|NCT01474291|Secondary|Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Leflunomide|The percentage of participants who discontinued leflunomide treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.|Day 1 (assessment of discontinuations within prior 2 years)|Participants in the Tocilizumab Monotherapy group (Efficacy population) who discontinued leflunomide and with available data.|||percentage of participants|||Number
2671798|NCT01474200|Secondary|CLINICAL: Mortality Rates Within Index Hospitalization or Within 90 Days After Hospital Discharge.|Death due to any cause.|Time from randomization to 90 days post-hospital discharge||||Percentage of Participants|||Number
2671765|NCT01474291|Primary|Number of Participants Assigned Tocilizumab Monotherapy Versus Tocilizumab as Part of Combination Therapy at Study Inclusion|The number of participants assigned to tocilizumab monotherapy versus tocilizumab combination therapy is reported. A multivariate analysis was performed to search for predictive factors for the initiation of tocilizumab in monotherapy.|Day 1|Efficacy population, defined as all participants who received at least one infusion of tocilizumab and who met all inclusion and exclusion criteria.|||participants|||Number
2671766|NCT01474239|Secondary|Time to WHO PS Deterioration|Time to WHO PS deterioration was defined as the time from randomization to the first date of deterioration of the WHO performance status score. WHO PS deterioration was defined as a decrease of at least 1 point with respect to the screening value. WHO PS is a 6-level score which ranges between 0 (fully active) to 5 (death); a lower score represents a higher ability to perform daily tasks.|Baseline until WHO PS deterioration (Up to 691 days)|ITT population.|||months||95% Confidence Interval|Median
2671767|NCT01474239|Secondary|Percentage of Participants With World Health Organization (WHO) Performance Status (PS) Deterioration|WHO PS deterioration was defined as a decrease of at least 1 point with respect to the screening value. WHO PS is a 6-level score which ranges between 0 (fully active) to 5 (death); a lower score represents a higher ability to perform daily tasks.|Baseline until WHO PS deterioration (Up to 691 days)|ITT population.|||percentage of participants|||Number
2671768|NCT01474239|Secondary|Time to Karnofsky Performance Status (KPS) Deterioration|Time to KPS deterioration was defined as the time from screening to the first date of deterioration of the KPS score. Deterioration of KPS was defined as a decrease of at least 20 percentage points with respect to the screening. KPS is an 11-level score which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks. Time to KPS deterioration was estimated using Kaplan Meier method. If the participant was not known to have the event, time was censored at the last available visit date.|Baseline until KPS deterioration (up to 691 days)|ITT population. Here, number of participants analyzed signified participants with evaluable data for this outcome.|||months||95% Confidence Interval|Median
2671769|NCT01474239|Secondary|Percentage of Participants With Karnofsky Performance Status (KPS) Deterioration|Deterioration of KPS was defined as a decrease of at least 20 percentage points with respect to the screening. KPS is an 11-level score which ranges between 0 (death) to 100 (complete healthy status); a higher score represents a higher ability to perform daily tasks.|Baseline until KPS deterioration (up to 691 days)|ITT population. Here, number of participants analyzed signified participants with evaluable data for this outcome.|||percentage of participants|||Number
2671770|NCT01474239|Secondary|Percentage of Participants in Each Class of Corticosteroid Use|Corticosteroid use was classified as: 1. No Change (if corticosteroid dose at each assessment was equal to baseline); 2. Decreased (if corticosteroid dose at each assessment was lower than baseline); 3. Increased (corticosteroid dose at each assessment was greater than baseline).|Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, post-treatment follow-up (up to Day 691)|"ITT population. Here, the number of participants analyzed signified participants with evaluable data for this outcome, and n signified participants with evaluable data for specified category for each arm, respectively."|||percentage of participants|||Number
2671771|NCT01474239|Secondary|Time to Corticosteroid Initiation|Time to corticosteroid initiation was defined as the time from screening to the start date of the first corticosteroid administration in participants not receiving corticosteroids at screening. The participant had the event if he/she started on corticosteroids with a dosage ≥2 mg dexamethasone equivalent. Instead, if the participant was not known to have the event, time was censored at the last available visit date. Time to corticosteroid initiation was estimated using Kaplan Meier method.|Baseline until recurrence (up to 691 days)|ITT population. Number of participants analyzed signified participants who were not receiving corticosteroids at screening.|||months||95% Confidence Interval|Median
2671772|NCT01474239|Secondary|Percentage of Participants With Corticosteroid Initiation During the Study Period|Corticosteroid initiation was assessed in participants not receiving corticosteroids at screening. The participant had the event if he/she started on corticosteroids with a dosage greater than equal to (>/=) 2 mg dexamethasone equivalent.|Baseline until recurrence (up to 691 days)|ITT population. Number of participants analyzed signified participants who were not receiving corticosteroids at screening.|||percentage of participants|||Number
2671773|NCT01474239|Secondary|Change From Screening in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores at Weeks 8, 16, 24, 32, 40, 48, 56, 64, and 72|EORTC QLQ-C30: included global health status/quality of life (QOL), functional scales (physical, role, cognitive, emotional, and social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores were averaged and transformed to 0-100 scale; a higher score for Global QOL/functional scales indicates better level of QOL/functioning, or a higher score for symptom scale indicates greater degree of symptoms.|Screening, Weeks 8, 16, 24, 32, 40, 48, 56, 64, and 72|"ITT population. Here, the number of participants analyzed signified participants with evaluable data for this outcome, and n signified participants with evaluable data for specified category for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2671774|NCT01474239|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)|Percentage of participants achieving CR or PR as overall response between first drug administration and documented disease progression were calculated. Tumor response was evaluated according to both the RANO and the Macdonald response criteria. As per Macdonald criteria, CR was defined as the disappearance of all enhancing disease, sustained for at least 4 weeks, and no new lesions along with clinical features of clinically stable or improved, with no corticosteroid; PR was defined as a 50% or more decrease of all measurable enhancing lesions, sustained for at least 4 weeks, and no new lesion along with clinical features of clinically stable or improved, with stable or reduced corticosteroids. RANO criteria defined CR and PR the same as Macdonald criteria with the following additions: CR - improved non enhancing T2/FLAIR lesions; PR - no progression of non-measurable disease, stable or improved non enhancing FLAIR/T2 lesions.|Baseline until disease progression or death (baseline, 46 days after first administration of study drug, and thereafter every 56 days up to 691 days)|ITT population.|||percentage of participants|||Number
2671775|NCT01474239|Secondary|Percentage of Participants Alive 30 Days After Last Dose of Study Drug|OS was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of MRI assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|30 days after last dose of study drug (up to Day 600)|ITT population. Here, the number of participants analyzed signified participants with evaluable data for this outcome.|||percentage of participants||95% Confidence Interval|Number
2671776|NCT01474239|Secondary|Percentage of Participants Alive 12 Months After Start of Treatment|OS was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of MRI assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|12 months|ITT population. Here, the number of participants analyzed signified participants with evaluable data for this outcome.|||percentage of participants||95% Confidence Interval|Number
2671777|NCT01474239|Secondary|Percentage of Participants Alive 9 Months After Start of Treatment|OS was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of MRI assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|9 months|ITT population.|||percentage of participants||95% Confidence Interval|Number
2671778|NCT01474239|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time in months from the start of treatment to the date of the first occurrence of disease progression or death from any cause, whichever occurred first. PFS was estimated by the Kaplan-Meier method. Progression was assessed using the RANO or the Macdonald Response Criteria, whichever occurred first. As per RANO criteria, progression was defined as 25% or more increase in enhancing lesions despite stable or increasing steroid dose; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease). As per Macdonald criteria, progression was defined as 25% or more increase in enhancing lesions; any new lesions; and clinical deterioration.|Baseline until disease progression or death (baseline, 46 days after first administration of study drug, and thereafter every 56 days up to 691 days)|ITT population.|||months||95% Confidence Interval|Median
2671779|NCT01474239|Secondary|Percentage of Participants Who Were Alive and Progression Free 6 Months After Start of Treatment|Progression-free survival (PFS) was defined as the time in months from the start of treatment to the date of the first occurrence of disease progression or death from any cause, whichever occurred first. PFS was estimated by the Kaplan-Meier method. Progression was assessed using Response Assessment in Neuro-Oncology (RANO) or Macdonald Response Criteria, whichever occurred first. As per the RANO criteria, progression was defined as 25% or more increase in enhancing lesions despite stable or increasing steroid dose; increase (significant) in non-enhancing T2/FLAIR lesions, not attributable to other non-tumor causes; any new lesions; and clinical deterioration (not attributable to other non-tumor causes and not due to steroid decrease). As per the Macdonald criteria, progression was defined as 25% or more increase in enhancing lesions; any new lesions; and clinical deterioration.|6 months|ITT population.|||percentage of participants||95% Confidence Interval|Number
2671780|NCT01474239|Primary|Overall Survival (OS)|OS was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of MRI assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|Baseline until death (up to 691 days)|ITT population.|||months||95% Confidence Interval|Median
2671781|NCT01474239|Primary|Percentage of Participants Alive 6 Months After Start of Treatment|Overall survival (OS) was defined as the time in months from the start of treatment to death due to any cause. If a participant was not known to have died, time was censored at the last date the participant was known to be alive, which was defined as the latest among date of last visit, date of last sample collected for laboratory exam, date of magnetic resonance imaging (MRI) assessment, date of last treatment, date of discontinuation and date of last available follow-up visit. Participants with no information after baseline were censored at Day 1. OS was estimated by the Kaplan-Meier method.|6 months|Intent-to-Treat (ITT) population included all randomized participants with at least one administration of the study drug.|||percentage of participants||95% Confidence Interval|Number
2671782|NCT01474213|Secondary|Post Intubation Score|"Post-intubation was scored from 1 to 3, with higher scores indicating a worse outcome.~Post-intubation score 1 2 3~Cooperative, obeying commands~Uncomfortable, GA imminent~Other（specify）"|immediately after the intubation||||units on a scale||Inter-Quartile Range|Median
2671783|NCT01474213|Primary|Intubation Score|graded from 0 to 5, with lower scores indicating better conditions Intubation score 0 1 2 3 4 5: 1)Grimacing when tube in nares 2)Localising with one limb at any stage 3)Localising with two limbs at any stage 4)Coughing on entering trachea 5)Prolonged coughing|during the inserting of the tracheal tube|Power calculation identified a minimum requirement of 15 patients randomized to each group to demonstrate a 20% difference in outcome scores with a power of 0.8 and a type I error of 0.05 according to our preliminary study.|||units on a scale||Inter-Quartile Range|Median
2671799|NCT01474200|Secondary|CLINICAL: All Cause Rehospitalization Rates at 30 and 90 Days|Any cause that required hospitalization for treatment within 90 days of index hospitalization discharge.|Within 30 days and 90 days after hospital discharge||||Rehospitalizations/100 Pt-Days at Risk|||Number
2671784|NCT01474213|Primary|Endoscopy Scores|"Endoscopy was graded from 0 to 5, with lower scores indicating a possibly better condition.~Endoscopy score 0 1 2 3 4 5: 1)Grimacing 2)localising 3)Coughing on lignocaine via scope 4)Coughing on entering infraglottic space 5)Prolonged coughing"|during the procedure of fibreoptic and tracheal intubation|Power calculation identified a minimum requirement of 15 patients randomized to each group to demonstrate a 20% difference in outcome scores with a power of 0.8 and a type I error of 0.05 according to our preliminary study.|||units on a scale||Inter-Quartile Range|Median
2671785|NCT01474213|Secondary|Cardiac Rhythm|Number of Participants with Abnormal Cardiac Rhythm(including any type of the abnormal cardiac rhythm from 15 minutes before intubation and during the intubation procedure was recorded such as sinus arrhythm, atrial or ventricular premature beats and atrioventricular block) was recorded.|15 minutes before intubation and duration of intubation||||participants|||Number
2671786|NCT01474213|Secondary|Peripheral Oxygen Saturation(SPO2)|Peripheral oxygen saturation at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.|15 minutes before intubation, endoscopy point, intubation point||||percentage oxygen saturation||Standard Deviation|Mean
2671787|NCT01474213|Secondary|Heart Rate|Heart rate at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.|15 minutes before intubation, endoscopy point, intubation point||||beats per minute||Standard Deviation|Mean
2671788|NCT01474213|Secondary|Mean Arterial Blood Pressure|MAP at 15 minutes before intuation, endoscopy point and intubation point between two groups were compared.|15 minutes before intubation, endoscopy point, intubation point||||mmHg||Standard Deviation|Mean
2671789|NCT01474213|Secondary|Post Operative Visit|visit the patients to ensure their memory of intubation. Postoperative interview asked the patients' memory of the fiberoptic intubation Amnesia Recall of endoscopy Yes No Recall of intubation Yes No The number is the patients who remember the operation procedure.|24 hours||||participants|||Number
2671790|NCT01474213|Secondary|Patient's Reaction to Procedure|"Ramsay score during the endoscopy intubation from 1 to 6. The higher scores means the deeper sedation level.~Clinical score Level of sedation~Patient is anxious and agitated or restless, or both~Patient is cooperative, oriented and tranquil~Patient responds to commands only~Patient exhibits a brisk response to a light glabellar (between the eyebrows) tap or loud auditory stimulus~Patient exhibits a sluggish response to a light glabellar tap or loud auditory stimulus~Patient exhibits no response to stimuli"|the duration of intubation, an expected average of 10 minutes|Power calculation identified a minimum requirement of 15 patients randomized to each group to demonstrate a 20% difference in outcome scores with a power of 0.8 and a type I error of 0.05 according to our preliminary study.|||units on a scale||Inter-Quartile Range|Median
2671791|NCT01474200|Secondary|SAFETY: Changes in Renal Function (Estimated Glomerular Filtration Rate) After Treatment up to 90 Days After Randomization|Changes in renal function prior to index treatment compared to various intervals by assessing the patient's serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula|Within 90 days of randomization|Number of participants analyzed changes over time. Discharge: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.|||mL/min/1.73m2||Standard Deviation|Mean
2671792|NCT01474200|Secondary|SAFETY: Changes in Renal Function (Blood Urea Nitrogen/Serum Creatinine) After Treatment up to 90 Days After Randomization|Changes in renal function prior to index treatment compared to various intervals by assessing the patient's serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula|Within 90 days of randomization|Number of participants analyzed changes over time. Discharge: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.|||mg/dL||Standard Deviation|Mean
2671793|NCT01474200|Secondary|SAFETY: Changes in Renal Function (Blood Urea Nitrogen) After Treatment up to 90 Days After Randomization|Changes in renal function prior to index treatment compared to various intervals by assessing the patient's serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula|Within 90 days of randomization|Number of participants analyzed changes over time. Baseline: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.|||mg/dL||Standard Deviation|Mean
2671794|NCT01474200|Secondary|SAFETY: Changes in Renal Function (Serum Creatinine) After Treatment up to 90 Days After Randomization|Changes in renal function prior to index treatment compared to various intervals by assessing the patient's serum creatinine (sCr), Blood Urea Nitrogen(BUN), BUN/sCr ratio and estimated glomerular filtration rate (eGFR) using the Modification of Diet in Renal Disease (MDRD) formula|Within 90 days of randomization|Number of participants analyzed changes over time. Discharge: n=105 for AQ arm, n=108 for LD arm. 30 days after discharge: n=93 for AQ arm, n=95 for LD arm. 60 days after discharge: n=85 for AQ arm, n=84 for LD arm. 90 days after discharge: n=4 for AQ arm, n=6 for LD arm.|||mg/dL||Standard Deviation|Mean
2671795|NCT01474200|Secondary|CLINICAL: Global Clinical Score at 30 and 90 Days After Discharge|KCCQ Questionnaire analysis based on patient's self-assessment of how they feel at various intervals compared to how they felt prior to index treatment. Scores were transformed to a range of 0-100, in which higher scores reflect better health status.|Within 90 days after hospital discharge|Number of participants analyzed changes over time. Baseline: n=107 for AQ arm, n=110 for LD arm. 30 day follow up: n=85 for AQ arm, n=92 for LD arm. 90 day follow up: n=72 for AQ arm, n=77 for LD arm.|||Scores on a Scale||Standard Deviation|Mean
2671796|NCT01474200|Secondary|CLINICAL: Quality of Life Assessed Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at 30, 60 and 90 Days After Discharge|Questionnaire assessed patients quality of life prior to index treatment versus timeframes following hospital discharge. Scores were transformed to a range of 0-100, in which higher scores reflect better health status.|Within 90 days after hospital discharge|Number of participants analyzed changes over time. Baseline: n=107 for AQ arm, n=110 for LD arm. 30 day follow up: n=85 for AQ arm, n=91 for LD arm. 90 day follow up: n=72 for AQ arm, n=77 for LD arm.|||Scores on a Scale||Standard Deviation|Mean
2671802|NCT01474200|Secondary|CLINICAL: Total Number of Heart Failure (HF) Rehospitalizations at 30 and 90 Days After Discharge|Number of different times patient was admitted to hospital for HF symptoms within 90 days of index hospitalization discharge.|Within 30 days and 90 days after hospital discharge||||Rehospitalizations|||Number
2671803|NCT01474200|Secondary|CLINICAL: Total Number of Emergency Department (ED) or Unscheduled Office Visits at 30 and 90 Days After Discharge|Number of visits for HF symptoms requiring ED or clinic treatment involving the use of IV diuretics and /or positive inotropic or vasodilator drugs|Within 30 days and 90 days after hospital discharge||||Visits|||Number
2671804|NCT01474200|Secondary|CLINICAL: Total Number of Days Rehospitalized for Heart Failure (HF) at 30 and 90 Days After Discharge|Days rehospitalized for HF symptoms requiring hospital, emergency room or clinic treatment involving the use of IV diuretics and /or positive inotropic or vasodilator drugs.|Within 30 days and 90 days after hospital discharge||||Days|||Number
2671805|NCT01474200|Secondary|CLINICAL: Length of Stay (LOS) During the Index Hospitalization|Number of days patient is in hospital for HF treatment.|Index hospitalization admission to index hospitalization discharge||||Days||Standard Deviation|Mean
2671806|NCT01474200|Secondary|EFFICACY: Changes in B-type Natriuretic Peptide (BNP) Levels Over Time|Change in BNP levels over time at 72 hours, discharge, and 90 days after discharge.|Baseline and at 72 hours from baseline, hospital discharge and at 90 days after hospital discharge|Number of participants analyzed changes over time. Baseline: n=108 for AQ arm, n=109 for LD arm. 72 hours from baseline: n=81 for AQ arm, n=77 for LD arm. Discharge: n=83 for AQ arm, n=89 for LD arm. 90 days follow up: n=65 for AQ arm, n=76 for LD arm.|||pg/mL||Standard Deviation|Mean
2671807|NCT01474200|Secondary|EFFICACY: Freedom From Congestion|Defined as jugular venous distention of < or equal to 8 cm, with no orthopnea, and with trace peripheral edema or no edema at hospital discharge|Index Hospitalization, an average of 8 days||||Participants|||Number
2671808|NCT01474200|Secondary|EFFICACY: Time to Freedom From Congestion|Time from hospital admission to time patient is free of congestion in the hospital. Freedom from congestion is defined as jugular venous distention of < or equal to 8 cm, with no orthopnea and with trace peripheral edema or no edema. Measurement taken every 24 hours after treatment initiation.|Index Hospitalization, an average of 8 days||||Days||Standard Deviation|Mean
2671809|NCT01474200|Secondary|EFFICACY: Total Weight Loss During the Index Hospitalization|Weight at hospital discharge minus weight at hospital admission. Negative mean values indicate weight loss.|Index Hospitalization, an average of 8 days||||lbs||Standard Deviation|Mean
2671810|NCT01474200|Secondary|EFFICACY: Weight Loss at 72 Hours After Initiation of Treatment|Weight at 72 hours after treatment initiation minus weight at treatment initiation. Negative mean values indicate weight loss.|72 hours after treatment initiation||||lbs||Standard Deviation|Mean
2671811|NCT01474200|Secondary|EFFICACY: Net Fluid Removed During the Index Hospitalization|AQ-Fluid removed by AQ plus urine voided minus fluid intake versus urine voided minus fluid intake with the IV diuretics.|Index Hospitalization, an average of 8 days||||mL||Standard Deviation|Mean
2671812|NCT01474200|Secondary|EFFICACY: Total Fluid Removed During the Index Hospitalization|AQ-Fluid removed by AQ plus urine voided versus urine voided when treated with IV diuretics|Index Hospitalization, an average of 8 days||||mL||Standard Deviation|Mean
2671813|NCT01474200|Primary|Time to First Heart Failure (HF) Event|"Time to first HF event within 90 days after discharge from index HF hospitalization. HF events are defined as~HF rehospitalization or~unscheduled outpatient or emergency room treatment with IV loop diuretics or~unscheduled outpatient Aquapheresis treatment"|90 days after discharge from index HF hospitalization.|Results reported are for the 25th percentile.|||Days||95% Confidence Interval|Median
2671814|NCT01474122|Secondary|Change in Hand Functionality - Hand Disability in Systemic Sclerosis - Digital Ulcers (HDISS-DU) Score From Baseline to Week 16|Patients were asked to answer 24 questions on the use of the hand(s) affected by DUs over the past 7 days on a 6-point scale from 0 (yes without difficulty) to 5 (impossible). The HDISS-DU score is the arithmetic mean of the valid non-missing items. The scores are interpreted as 1 (better ability in completing activities) to 6 (worst ability in completing activities)|Baseline to Week 16|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.|||Units on a scale||Standard Deviation|Mean
2671815|NCT01474122|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Overall Score From Baseline to Week 16|HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function).|Baseline to Week 16|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.|||Units on a scale||Standard Deviation|Mean
2671816|NCT01474122|Secondary|Change in Hand Functionality Health Assessment Questionnaire - Disability Index (HAQ-DI) Hand Component From Baseline to Week 16|HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function). Hand functionality was assessed using a composite of 4 domains (dressing and grooming, grip, hygiene, and eating).|Baseline to Week 16|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.|||Units on a scale||Standard Deviation|Mean
2671935|NCT01473589|Secondary|Percentage of Participants Able to Ambulate|Ability to ambulate was defined as ambulatory with convalescent aid or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / number of total participants analyzed) * 100.|Up to 12 months|Participants who were randomized and received at least 1 dose of study drug and had at least 1 nonmissing post-baseline measurement. LOCF values used.|||percentage of participants|||Number
2671817|NCT01474122|Secondary|Percentage of Participants With at Least One DU Complication|"DU complications were defined as any one of the following:~resulting from DU worsening: critical ischemic crisis necessitating hospitalization; gangrene, (auto)amputation; failure of conservative management; surgical and chemical sympathectomy, vascular reconstructions, or any unplanned surgery in the management of hand SSc manifestations; use of parenteral prostanoids; use of endothelin-receptor antagonists; class II, III, or IV narcotics or a > 50% increase in the existing dose compared with baseline; initiation of systemic antibiotics for the treatment of infection attributed to DUs."|Up to 95 weeks|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.|||Percentage of participants|||Number
2671818|NCT01474122|Secondary|Percentage of Participants Without a New DU up to Week 16|DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Numbers of patients with no new DU at Week 16 are imputed using the last observation carried forward method.|Baseline to Week 16|Modified intention to treat set. Ten patients were excluded from the modified intent to treat set due to protocol violations.|||Percentage of participants|||Number
2671819|NCT01474122|Primary|Incidence Rate of New Digital Ulcers (DUs) up to Week 16|DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Incidence rate is adjusted for 16 weeks of observation, hence is calculated as the number of new DUs/total number of observation days.|Baseline to Week 16|Full analysis set|||new DUs/16 weeks|||Number
2671820|NCT01474109|Secondary|Change in Hand Functionality - Hand Disability in Systemic Sclerosis - Digital Ulcers (HDISS-DU) Score From Baseline to Week 16|Patients were asked to answer 24 questions on the use of the hand(s) affected by DUs over the past 7 days on a 6-point scale from 0 (yes without difficulty) to 5 (impossible). The HDISS-DU score is the arithmetic mean of the valid non-missing items. The scores are interpreted as 1 (better ability in completing activities) to 6 (worst ability in completing activities)|Baseline to week 16|Modified intention-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.|||units on a scale||Standard Deviation|Mean
2671821|NCT01474109|Secondary|Health Assessment Questionnaire - Disability Index (HAQ-DI) Overall Score From Baseline to Week 16|HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function).|Baseline to week 16|Modified intention-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.|||units on a scale||Standard Deviation|Mean
2671822|NCT01474109|Secondary|Change in Hand Functionality Health Assessment Questionnaire - Disability Index (HAQ-DI) Hand Component From Baseline to Week 16|HAQ-DI assesses functional ability regarding fine movements of the upper extremities, locomotor activities in the lower extremities, and movements of the upper and lower limbs. Responses were extracted from the Scleroderma Health Assessment Questionnaire covering 8 domains of functional disability (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other daily activities). A mean score ranging from 0-3 was calculated for each domain, and a composite score by dividing the summed domain scores by the number of domains. The composite score was interpreted as 0 (no impairment in function) to 3 (maximal impairment of function). Hand functionality was assessed using a composite of 4 domains (dressing and grooming, grip, hygiene, and eating).|Baseline to week 16|Modified intention-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.|||units on a scale||Standard Deviation|Mean
2671823|NCT01474109|Secondary|Percentage of Participants With at Least One DU Complication|DU complications were defined as any one of the following, resulting from DU worsening: critical ischemic crisis necessitating hospitalization; gangrene, (auto)amputation; failure of conservative management; surgical and chemical sympathectomy, vascular reconstructions, or any unplanned surgery in the management of hand SSc manifestations; use of parenteral prostanoids; use of endothelin-receptor antagonists; class II, III, or IV narcotics or a > 50% increase in the existing dose compared with baseline; initiation of systemic antibiotics for the treatment of infection attributed to DUs.|Up to approximately 90 weeks|Modified intent-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.|||percentage of participants|||Number
2671824|NCT01474109|Secondary|Percentage of Participants Without a New DU Up To Week 16|DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Numbers of patients with no new DU at Week 16 are imputed using the last observation carried forward method.|Baseline to week 16|Modified intent-to-treat set. Eleven patients were excluded from the modified intent-treat set due to protocol violations.|||Percentage of participants|||Number
2671825|NCT01474109|Primary|Incidence Rate of New Digital Ulcers (DUs) up to Week 16|DUs were assessed at each visit starting with the screening visit. Only DUs from the proximal interphalangeal joint (PIP) distally (both on the dorsal and volar surface of the hand, including the digital tip) were recorded. The location of each DU was noted. At each subsequent visit the location of each new DU was noted. DUs that occurred and healed between visits and were reported by patients were not recorded as new DUs. The evaluation was performed by an experienced physician or a trained rater with expertise in the assessment of DUs in systemic sclerosis (SSc). For a given patient, DUs were assessed by the same rater at each visit, whenever possible. Any DU that developed over a previously healed ulcer was recorded as a new DU. Incidence rate is adjusted for 16 weeks of observation, hence is calculated as the number of new DUs/total number of observation days.|Baseline to week 16|Full analysis set|||number of new DUs/observation days|||Number
2671826|NCT01474018|Secondary|Total Daily Insulin Dose|Change in total daily insulin dose in patients treated with QR-Bromocriptine +metformin +insulin compared to metformin + insulin alone|Baseline - 24 weeks||||units of insulin||Standard Error|Mean
2671827|NCT01474018|Primary|Change in A1c|Change from baseline HbA1c between subjects receiving QR-Bromocriptine + metformin + insulin compared to those subjects receiving metformin + insulin|Baseline - 24 weeks||||percent HbA1c||Standard Error|Mean
2671828|NCT01473992|Primary|Physical Functional Performance (Continuous Scale; 10-items)|Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.|Accommodation with knee systems is approximately 90 days. This test takes less than 1hr to complete.||||scores on a scale||Standard Deviation|Mean
2671829|NCT01473992|Secondary|Prosthesis Evaluation Questionnaire: Utility Score.|The Prosthetics Evaluation Questionnaire (PEQ) was used as a validated survey to solicit participants' subjective experience and feedback regarding prosthesis-related function and quality of life. PEQ domains are ordinally scaled from 0 (worst or most negative feeling/response) to 7 (best or most positive feeling/response).|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.||||score on a scale||Full Range|Median
2671830|NCT01473992|Secondary|Balance and Stability|Balance and stability will be assessed for limits of stability using the Biodex SD. The limit of stability score is a scaled score with a possible range of 0 (worst possible outcome) to 100 (best possible outcome)based on variability of the trajectory of the center of mass while weight shifting on a force platform.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.||||scores on a scale||Standard Deviation|Mean
2671831|NCT01473992|Primary|75 Meter Self Selected Walking Test|Time to Complete a 75 meter walking distance.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.||||seconds||Standard Deviation|Mean
2671832|NCT01473953|Secondary|Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up||Day 0 and Day 21|The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation ‘as treated’.|||participants|||Number
2671833|NCT01473953|Secondary|Area Under the Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects With Liraglutide 6 mg/ml Pre-treatment||0 to 168 hours after dosing|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. Cohorts with liraglutide pre-treatment were not initiated based on review of pharmacokinetic data, and hence no analysis was done.||||||
2671834|NCT01473953|Secondary|Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment||1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. 1 subject was not included for this evaluation in the cohort 1a arm due to insufficient data. Cohorts with liraglutide pre-treatment were not initiated based on review of pharmacokinetic data, and hence no analysis was done.|||pmol.h/L||Geometric Coefficient of Variation|Geometric Mean
2671835|NCT01473953|Secondary|Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity||Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. 1 subject was not included for this evaluation in the cohort 1a arm due to insufficient data. This evaluation was not done on placebo cohort.|||pmol.h/L||Geometric Coefficient of Variation|Geometric Mean
2671836|NCT01473953|Secondary|Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot||Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. This evaluation was not done on placebo cohort.|||hours||Geometric Coefficient of Variation|Geometric Mean
2671837|NCT01473953|Secondary|Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot||Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose|Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment. This evaluation was not done on placebo cohort.|||pmol/L||Geometric Coefficient of Variation|Geometric Mean
2671838|NCT01473953|Primary|Number of Treatment Emergent Adverse Events (TEAEs)|TEAEs: AEs from 1st exposure (exp) until follow-up (FU) or AEs with onset before 1st exp increasing in severity up to the FU. Mild AEs: no or transient symptoms, no interference (inf) with subject's daily activities. Moderate AEs: marked symptoms, moderate inf with subject's daily activities. Severe AEs: considerable inf with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in death/ a life-threatening experience/ in-subject hospitalization/prolongation of existing hospitalisation; or persistent/significant disability/incapacity/congenital anomaly/birth defect.|Day 0 and up to 21 days after treatment|The safety analysis set includes all subjects who were exposed to at least one dose of trial product. Subjects in the safety analysis set contribute to the evaluation ‘as treated’.|||events|||Number
2671839|NCT01473940|Post-Hoc|Duration of Response in Patients Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination|"Duration of response is shown below for patients who showed a response as defined by immune-related response criteria (irCR) as either of the following:~irComplete Response (irCR)-Complete disappearance of all index lesions or irPartial Response (irPR)-Decrease of 50% or greater in the sum of products of the two largest perpendicular diameters of all index and all new measurable lesions (i.e., percentage change in tumor burden)~Duration of response is defined as the time from first documentation of response to first documentation of progression, with progression defined as:~irProgressive Disease (irPD)-At least 25% increase in the percentage change in tumor burden (i.e., taking sum of all the products of all the index lesions and any new lesions) when compared to the sum of all the product diameters (SPD) at nadir."|From the time of response and every 12 weeks during treatment with a 12 week induction and then 28 day maintenance cycles. Range of cycles completed (including induction cycle) 0-10|Only patients with a response are shown here.|||months|||Number
2671840|NCT01473940|Secondary|Recovery of Tumor Immune Surveillance: T-cell Response to Defined Pancreatic Cancer Tumor Antigens|Optional blood draws to analyze the inflammatory T cell function before, during and after treatment.|Prior to ipilimumab infusion at weeks 1, 4, 7, and 10, and then every 12 weeks starting at week 13 where range of cycles including induction cycle was 0-10 (Induction cycle = 12 weeks, maintenance cycle = 28 days)|Due to this being optional, insufficient samples were obtained and no data or analysis of blood was completed.||||||
2671841|NCT01473940|Secondary|Overall Survival (OS) in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination|Overall Survival (OS) was estimated using a kaplan-meier curve with 0 patients censored. OS is defined from the time of treatment initiation until the time of death from any cause. Any patient without the event at the time of analysis will be censored from the last documented contact.|Every 12 weeks during treatment with a 12 week induction and then 28 day maintenance cycles. Range of cycles completed (including induction cycle) 0-10|Cohort 2 and expansion cohorts are combined for this outcome measure as they were both at the MTD doses.|||months||95% Confidence Interval|Median
2671842|NCT01473940|Secondary|Progression Free Survival (PFS) in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination|Median Progression Free Survival (mPFS) was estimated using a Kaplan-Meier curve with 0 censored patients. PFS is defined from the time of treatment initiation until the first documentation of progressive disease. Any patient without the event at the time of analysis will be censored from the last documented contact.|Every 12 weeks during treatment with a 12 week induction and then 28 day maintenance cycles. Range of cycles completed (including induction cycle) 0-10|Cohort 2 and expansion cohorts are combined for this outcome measure as they were both at the MTD doses.|||months||95% Confidence Interval|Median
2671843|NCT01473940|Secondary|Time to Progression Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination Who Progress While on Treatment|Time to Progression will be defined as the time from treatment initiation until the first documentation of progression as calculated by irRC in patients who show progression. Progression will be defined as at least a 25% increase percentage change in tumor burden (i.e., taking the sum of all the products of all index lesions and any new lesions) when compared to sum of all the products of diameters (SPD) at nadir.|Every 12 weeks during treatment with a 12 week induction and then 28 day maintenance cycles. Range of cycles completed (including induction cycle) 0-10|PFS was considered to be a more meaningful outcome measure to report on. This outcome measure was so similar that it was considered duplicate information and data was not collected and analyzed specifically for this outcome measure.||||||
2671844|NCT01473940|Secondary|Response Rate Using Immune-related Response Criteria (irRC) in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination|"Response will be assessed using CT of MRI scans immune-related response criteria (irRC). The sum of all the products of diameters (SPD) at tumor assessment using the irRC for progressive disease incorporates the contribution of new measurable lesions. Each net percentage change in tumor burden per assessment using irRC accounts for the size and growth kinetics of both old and new lesions as they appear.~irComplete Response (irCR)-Complete disappearance of all index lesions. irPartial Response (irPR)-Decrease of 50% or greater in the sum of products of the two largest perpendicular diameters of all index and all new measurable lesions (i.e., percentage change in tumor burden) irStable Disease (irSD)-does not meet criteria for irCR or ir PR, in the absence of progressive disease.~irProgressive Disease (irPD)-At least 25% increase in the percentage change in tumor burden (i.e., taking sum of all the products of all the index lesions and any new lesions) when compared to SPD at nadir."|Every 12 weeks during treatment with a 12 week induction and then 28 day maintenance cycles. Range of cycles completed (including induction cycle) 0-10||||Participants|||Count of Participants
2671845|NCT01473940|Primary|Number of Dose Limiting Toxicities (DLTs) Seen in Patients With Pancreas Adenocarcinoma Treated With Ipilimumab and Gemcitabine Combination in Order to Define the Maximum Tolerated Dose (MTD)|"Dose limiting toxicity (DLT) will be monitored by calculating the Bayesian predictive probability of a DLT given the data to date. All toxicities will be summarized in a descriptive manner as to type, frequency, attribution and timing by dose level. Safety will be evaluated for all treated patients using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 where grading is as follows:~Mild (grade 1) Moderate (grade 2) Severe (grade 3) Life-threatening (grade 4) Fatal (grade 5)~In general a DLT will be defined as any any of the following drug-related toxicities:~Febrile neutropenia with grade 3/4 neutropenia Asymptomatic grade 4 neutropenia more than 7 days Grade 3 thrombocytopenia with grade 3-4 hemorrhage or grade 4 thrombocytopenia Non-hematologic toxicity grade 3 or 4 (with some protocol specified exceptions)~DLTs will be used to determine the MTD for the expansion cohort of the study.~*AST = Aspartate transamina"|During the 12 weeks of Induction Therapy||||DLTs|||Number
2671846|NCT01473836|Secondary|Number of Participants Analyzed for Population Pharmacokinetics (PK) of Metronidazole|Population pharmacokinetic analysis of Metronidazole is conducted by combining current study data with other Metronidazole studies.|Four samples were taken at any infusion after the first dosing: during infusion, immediately after end of infusion, between 15 and 60 minutes after end of infusion, and between 2 hours and immediately before the start of the next infusion.|No population pharmacokinetic analysis results are available just for the current study.||||||
2673497|NCT01461551|Primary|Lymphocyte Count|Blood samples were obtained 24 h after the surgery for routine blood examination. This analysis was performed in the hospital laboratory using routine laboratory procedures.|1 day after surgery||||cells/nanoliter||Standard Deviation|Mean
2671847|NCT01473836|Secondary|Bacteriological Response: Eradication Rate (Investigator Assessment)|"Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the investigator at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, number of participants with bacteria eradication, presumed eradication or colonization over total number of participants that excluding ones evaluated as indeterminate multiplied by 100."|Baseline to Day 4, EOT (up to 14 days), TOC|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified on Day 1 prior to the initial dose. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."|||percentage of participants||95% Confidence Interval|Number
2671848|NCT01473836|Secondary|Bacteriological Response: Eradication Rate (Data Review Committee Assessment)|"Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the data review committee, at Day 4, at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, number of participants with bacteria eradication, presumed eradication or colonization over total number of participants that excluding ones evaluated as indeterminate multiplied by 100."|Baseline to Day 4, EOT (up to 14 days), TOC|"Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified on Day 1 prior to the initial dose. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."|||percentage of participants||95% Confidence Interval|Number
2671849|NCT01473836|Secondary|Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment)|"The appropriateness of treatment continuation was evaluated on Day 4 by the investigator as continuation, discontinuation or indeterminate based on the clinical response. The percentage of participants was calculated from the following formula; number of participants assessed as continuation over total number of participants that excluding ones assessed as indeterminate multiplied by 100."|Baseline to Day 4|"Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."|||percentage of participants|||Number
2671850|NCT01473836|Secondary|Clinical Response: Response Rate (Investigator Assessment)|"Clinical response was evaluated by the investigator as effective (cured or improved), ineffective (not meeting effective criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; number of participants evaluated as effective over total number of participants that excluding ones evaluated as indeterminate multiplied by 100."|Baseline to EOT (up to 14 days), TOC|"Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."|||percentage of participants||95% Confidence Interval|Number
2671851|NCT01473836|Primary|Clinical Response: Response Rate (Data Review Committee Assessment)|"Clinical response was evaluated by the data review committee as effective (cured or improved), ineffective (not meeting effective criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; number of participants evaluated as effective over total number of participants that excluding ones evaluated as indeterminate multiplied by 100."|Baseline to EOT (up to 14 days), TOC|"Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as indeterminate."|||percentage of participants||95% Confidence Interval|Number
2671852|NCT01473758|Secondary|Change From Baseline in Aortic Pulse Wave Velocity in a Subset of Participants (Extended Approach)|Carotid-femoral aortic pulse wave velocity (aPWV) will be measured in a subset of participants to determine changes in arterial stiffness. A negative change from Baseline indicates improvement. Covariates for MMRM are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Days 14 and 28|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||meters/second||Standard Error|Least Squares Mean
2671853|NCT01473758|Secondary|Change From Baseline in Aortic Pulse Wave Velocity in a Subset of Participants (Initial Approach)|Carotid-femoral aortic pulse wave velocity (aPWV) will be measured in a subset of participants to determine changes in arterial stiffness. A negative change from Baseline indicates improvement. Covariates for MMRM are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Days 14 and 28|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||meters/second||Standard Error|Least Squares Mean
2672014|NCT01473407|Secondary|Total Dose of Study Medication Administered||Week 1 up to Week 24|"ITT population included all participants who were randomized to study treatment. Here, N signifies number of participants who were evaluable for this outcome measure."|||units of study medication||Standard Deviation|Mean
2671854|NCT01473758|Secondary|Exacerbation Length (Extended Approach)|Exacerbation length is the period from start of increased symptoms to end of increased symptoms; the last day of an exacerbation was to be followed by 2 days without symptom entries in the diary.|8 Weeks|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||days||95% Confidence Interval|Median
2671855|NCT01473758|Secondary|Exacerbation Length (Initial Approach)|Exacerbation length is the period from start of increased symptoms to end of increased symptoms; the last day of an exacerbation was to be followed by 2 days without symptom entries in the diary.|8 Weeks|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||days||95% Confidence Interval|Median
2671856|NCT01473758|Secondary|Change From Stable State in Diaries Hours Out of the Home Weekly Average (Extended Approach)|Estimates of the length of time the participants were out of their own home on the previous day were recorded in a daily diary. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||hours||Standard Error|Least Squares Mean
2671857|NCT01473758|Secondary|Change From Stable State in Diaries Hours Out of the Home Weekly Average (Initial Approach)|Estimates of the length of time the participants were out of their own home on the previous day were recorded in a daily diary. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||hours||Standard Error|Least Squares Mean
2671858|NCT01473758|Secondary|Change From Stable State in Diaries Treatment Score Weekly Average (Extended Approach)|Any changes in the participant's usual treatment were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||score on a scale||Standard Error|Least Squares Mean
2671859|NCT01473758|Secondary|Change From Stable State in Diaries Treatment Score Weekly Average (Initial Approach)|Any changes in the participant's usual treatment were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||score on a scale||Standard Error|Least Squares Mean
2671860|NCT01473758|Secondary|Change From Stable State in Diaries Symptom Score Weekly Average (Extended Approach)|Any increase in the following respiratory symptoms: dyspnea, sputum purulence, sputum amount, wheeze, sore throat, cough, fever, symptoms of a common cold, ie, nasal congestion and discharge over the previous 24 hours were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||score on a scale||Standard Error|Least Squares Mean
2671861|NCT01473758|Secondary|Change From Stable State in Diaries Symptom Score Weekly Average (Initial Approach)|Any increase in the following respiratory symptoms: dyspnea, sputum purulence, sputum amount, wheeze, sore throat, cough, fever, symptoms of a common cold, ie, nasal congestion and discharge over the previous 24 hours were recorded in a daily diary. Diaries Symptom Score range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||score on a scale||Standard Error|Least Squares Mean
2671862|NCT01473758|Secondary|Change From Stable State in Diaries Peak Expiratory Flow (PEF) Weekly Average (Extended Approach)|Morning post-medication PEF (the best of 3 attempts measured with a mini-Wright peak-flow meter) was recorded in a daily diary. A positive change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||liters/minute||Standard Error|Least Squares Mean
2672015|NCT01473407|Secondary|Mean Weekly Dosage of Study Medication Through 24 Weeks||Week 1 up to Week 24|"ITT population included all participants who were randomized to study treatment. Here, N signifies number of participants who were evaluable for this outcome measure."|||U/kg/week||Standard Deviation|Mean
2671863|NCT01473758|Secondary|Change From Stable State in Diaries Peak Expiratory Flow (PEF) Weekly Average (Initial Approach)|Morning post-medication PEF (the best of 3 attempts measured with a mini-Wright peak-flow meter) was recorded in a daily diary. A positive change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||liters/minute||Standard Error|Least Squares Mean
2671864|NCT01473758|Secondary|Change From Stable State in Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Extended Approach)|The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, time point, treatment by time point and baseline by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||scores on a scale||Standard Error|Least Squares Mean
2671865|NCT01473758|Secondary|Change From Stable State in Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Initial Approach)|The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, time point, treatment by time point and baseline by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||score on a scale||Standard Error|Least Squares Mean
2671866|NCT01473758|Secondary|Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Extended Approach)|The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status.|Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||score on a scale||Standard Deviation|Mean
2671867|NCT01473758|Secondary|Exacerbations of Chronic Pulmonary Disease Test (EXACT-PRO) Weekly Averages (Initial Approach)|The EXACT-PRO questionnaire is a new, validated, and standardized measure to evaluate the frequency, severity, and duration of COPD exacerbations. It is a 14-item daily diary, and scores range from 0 to 100, with higher scores indicating worse health status.|Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||score on a scale||Standard Deviation|Mean
2671868|NCT01473758|Secondary|Change From Stable State in Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Extended Approach)|The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients' health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient's wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst). A negative change from Baseline indicates improvement. Covariates for MMRM are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||scores on a scale||Standard Error|Least Squares Mean
2671869|NCT01473758|Secondary|Change From Stable State in Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Initial Approach)|The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients' health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient's wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst). A negative change from Baseline indicates improvement. Covariates for MMRM are stable state value, treatment, time point, and treatment by time point interaction.|Baseline and Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||score on a scale||Standard Error|Least Squares Mean
2671870|NCT01473758|Secondary|Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Extended Approach)|The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients' health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient's wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst).|Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||score on a scale||Standard Deviation|Mean
2671996|NCT01473407|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Physical Examination|Physical examination included examination of the following: skin, eyes, ears, throat, cardiac, respiratory, gastrointestinal, genitourinary and musculoskeletal systems. Participants with clinically significant change from baseline in physical examination were as determined by the investigator.|Baseline up to Week 28|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2671871|NCT01473758|Secondary|Chronic Obstructive Pulmonary Assessment Test (CAT) Weekly Averages (Initial Approach)|The CAT is a short, validated, patient-completed questionnaire to assess the impact of COPD on health status. It comprises 8 questions that cover a broad range of effects of COPD on patients' health. Each question is scored in a range between 0 and 5, with the higher end indicating a higher impact of COPD on the patient's wellbeing. The CAT Total score ranges from 0 best) to 40 (Worst).|Weeks 1, 2, 3, 4, 5, 6, 7 and 8|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||score on a scale||Standard Deviation|Mean
2671872|NCT01473758|Secondary|Change From Baseline in FEV1/FVC (Extended Approach)|FEV1/FVC is the percentage of the vital capacity which is expired in the first second of maximal expiration. In healthy patients the FEV1/FVC is usually around 70%. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||percent||Standard Error|Least Squares Mean
2671873|NCT01473758|Secondary|Change From Baseline in FEV1/FVC (Initial Approach)|FEV1/FVC is the percentage of the vital capacity which is expired in the first second of maximal expiration. In healthy patients the FEV1/FVC is usually around 70%. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||percent||Standard Error|Least Squares Mean
2671874|NCT01473758|Secondary|Change From Baseline in Forced Vital Capacity (FVC) (Extended Approach)|Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||liters||Standard Error|Least Squares Mean
2671875|NCT01473758|Secondary|Change From Baseline in Forced Vital Capacity (FVC) (Initial Approach)|Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||liters||Standard Error|Least Squares Mean
2671876|NCT01473758|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) (Extended Approach)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||liters||Standard Error|Least Squares Mean
2671877|NCT01473758|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) (Initial Approach)|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Pulmonary function testing was performed using spirometry. A positive change from Baseline indicates an improvement. A Mixed Model Repeated Measurement (MMRM) was used for analysis with Baseline value, treatment, visit, and treatment by visit interaction as covariates.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||liters||Standard Error|Least Squares Mean
2671878|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Glucose (Extended Approach)|Blood was collected and analyzed for serum glucose levels. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||mmol/L||Standard Error|Least Squares Mean
2671879|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Glucose (Initial Approach)|Blood was collected and analyzed for serum glucose levels. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||mmol/L||Standard Error|Least Squares Mean
2671997|NCT01473407|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)|ECG parameters: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in ECG were as determined by the investigator.|Baseline up to Week 28|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2672059|NCT01472874|Secondary|Zn Urine||Pre Treatment (mean)||||mcg/24hr||Standard Deviation|Mean
2671880|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Fibrinogen (Extended Approach)|Biomarker Plasma fibrinogen was determined using the method described by Clauss. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||umol/L||Standard Error|Least Squares Mean
2671881|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Fibrinogen (Initial Approach)|Biomarker Plasma fibrinogen was determined using the method described by Clauss. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||umol/L||Standard Error|Least Squares Mean
2671882|NCT01473758|Secondary|Change From Baseline in Blood Biomarker C-reactive Protein (CRP) (Extended Approach)|Blood was collected and serum biomarker CRP was measured using Roche Modular Analytics E 170 Module. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||mg/L||Standard Error|Least Squares Mean
2671883|NCT01473758|Secondary|Change From Baseline in Blood Biomarker C-reactive Protein (CRP) (Initial Approach)|Blood was collected and serum biomarker CRP was measured using Roche Modular Analytics E 170 Module. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||mg/liter(L)||Standard Error|Least Squares Mean
2671884|NCT01473758|Secondary|Change From Baseline in Blood Biomarker IL-1β (Extended Approach)|Blood was collected and serum biomarker IL-1β was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||pg/mL||Standard Error|Least Squares Mean
2671885|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Interleukin-1 Beta (IL-1β) (Initial Approach)|Blood was collected and serum biomarker IL-1β was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||pg/mL||Standard Error|Least Squares Mean
2671886|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Interleukin (IL)-6 (Extended Approach)|Blood was collected and serum biomarker IL-6 was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||pg/mL||Standard Error|Least Squares Mean
2671887|NCT01473758|Secondary|Change From Baseline in Blood Biomarker Interleukin (IL)-6 (Initial Approach)|Blood was collected and serum biomarker IL-6 was quantified using commercial sandwich ELISA. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||pg/mL||Standard Error|Least Squares Mean
2671888|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Neutrophil Elastase (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker Neutrophil Elastase was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||µg/mL||Standard Error|Least Squares Mean
2671889|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Neutrophil Elastase (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker Neutrophil Elastase was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||µg/mL||Standard Error|Least Squares Mean
2671890|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Myeloperoxidase (MPO) (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker MPO was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||ng/mL||Standard Error|Least Squares Mean
2671891|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Myeloperoxidase (MPO) (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker MPO was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||ng/mL||Standard Error|Least Squares Mean
2671892|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-8 (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-8 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||pg/mL||Standard Error|Least Squares Mean
2671893|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-8 (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-8 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||pg/mL||Standard Error|Least Squares Mean
2671894|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-6 (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-6 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||pg/mL||Standard Error|Least Squares Mean
2671895|NCT01473758|Secondary|Change From Baseline in Sputum Marker Concentration of Interleukin (IL)-6 (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Sputum inflammatory marker IL-6 was quantified by commercial sandwich enzyme-linked immunosorbent assays (ELISA). A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||pg/mL||Standard Error|Least Squares Mean
2671896|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Lymphocytes (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of lymphocytes was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||percentage of lymphocytes||Standard Error|Least Squares Mean
2671897|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Lymphocyte (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of lymphocytes was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||percentage of lymphocytes||Standard Error|Least Squares Mean
2672012|NCT01473407|Secondary|Percentage of Participants Who Required Permanent Dose Changes of Study Medication||Week 1 up to Week 24|Per protocol population was a subset of ITT participants who did not have major protocol violations.|||percentage of participants|||Number
2672060|NCT01472874|Secondary|Cu Urine||Months 1,2,3,6,9,12 (mean)||||mcg/24hr||Standard Deviation|Mean
2671898|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Eosinophils (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of eosinophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||percentage of macrophages||Standard Error|Least Squares Mean
2671899|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Eosinophils (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of eosinophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||percentage of eosinophils||Standard Error|Least Squares Mean
2671900|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Macrophages (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of macrophages was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||percentage of macrophages||Standard Error|Least Squares Mean
2671901|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Macrophages (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of macrophages was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||percentage of macrophages||Standard Error|Least Squares Mean
2671902|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Neutrophils (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of neutrophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction. A negative change from Baseline indicates improvement.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||percentage of neutrophils||Standard Error|Least Squares Mean
2671903|NCT01473758|Secondary|Change From Baseline in Sputum Marker Percentage of Neutrophils (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Aliquots of a cell suspension prepared from the sputum sample were used to prepare cytospin slides that were stained with Diff-Quik for differential cell counts. 100 cells were counted and the percentage of neutrophils was determined. A negative change from Baseline indicated improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||percentage of neutrophils||Standard Error|Least Squares Mean
2671904|NCT01473758|Secondary|Change From Baseline in Sputum Marker Total Cells (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||10^6 cells/gram sputum||Standard Error|Least Squares Mean
2671936|NCT01473589|Secondary|Percentage of Participants With Functional Evidence of Healing|"Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s.~Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) * 100."|12 Months|Participants who were randomized, received at least 1 dose of study drug, and had either at least one nonmissing gait speed or non-ambulatory status. LOCF values used.|||percentage of participants|||Number
2671905|NCT01473758|Secondary|Change From Baseline in Sputum Marker Total Cells (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. Covariates for Mixed Model Repeated Measurement (MMRM) are baseline value, treatment, visit, and treatment by visit interaction.|Baseline and Day 7, Day 14, Day 28 and Day 56|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||10^6 cells/gram sputum||Standard Error|Least Squares Mean
2671906|NCT01473758|Secondary|Percentage of Participants Whose Sputum Neutrophil Counts Returned to Stable State at Day 14 (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) and were determined with a Neubauer hemocytometer.|Day 14|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||percentage of participants||95% Confidence Interval|Number
2671907|NCT01473758|Secondary|Percentage of Participants Whose Sputum Neutrophil Counts Returned to Stable State at Day 14 (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) and were determined with a Neubauer hemocytometer.|Day 14|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Initial Approach Analysis included all participants who received treatment in Cycle 1.|||percentage of participants||95% Confidence Interval|Number
2671908|NCT01473758|Primary|Change From Baseline in Sputum Neutrophil Counts at Day 14 Post Exacerbation (Extended Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model was used with neutrophil count at Baseline and treatment as independent variables, fixed effects.|Baseline and Day 14|Participants from the Intent-to-treat population, all randomized participants, with data available at the given time-point. Extended Approach Analysis included all participants who received treatment in Cycle 1 and participants who were re-randomized and received treatment in Cycle 2.|||10^6 cells/gram sputum||Standard Error|Least Squares Mean
2671909|NCT01473758|Primary|Change From Baseline in Sputum Neutrophil Counts at Day 14 Post Exacerbation (Initial Approach)|Sputum samples were collected and processed at the investigational site according to their standard procedures. Total cell count (absolute number of nonsquamous cells per gram of the original sputum sample) were determined using a Neubauer hemocytometer. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model was used with neutrophil count at Baseline and treatment as independent variables, fixed effects.|Baseline and Day 14|Participants from the Intent-to-treat (ITT) population, all randomized participants, with data available at the given time-point. Analysis included all participants who received treatment in Cycle 1.|||10^6 cells/gram sputum||Standard Error|Least Squares Mean
2671910|NCT01473745|Secondary|1 Nasolabial Angular Parameters|2D nasolabial angular parameter: Nasolabial angle (NLA) (The NLA was a two dimensional measurement and was measured at the midsagittal plane with Image J software®)|up to post-operation 6 months||||degree||Standard Deviation|Mean
2671911|NCT01473745|Secondary|14 Nasolabial Linear Parameters|"baseline characteristics: intercanthulus distance~nasal linear parameters~nasolabial linear parameters"|up to post-operation 6 months||||mm||Standard Deviation|Mean
2671912|NCT01473745|Primary|Soft and Hard Tissue Landmarks Movement|"The investigator measured the movement (1 month minus baseline) of hard tissue landmarks before and after 4-6 weeks maxillary LeFort I osteotomy. The movement (6 months minus baseline) of soft tissue landmarks was measured before and after 6 months of the maxillary LeFort I osteotomy.~The 3D directional movement of each point was measured in the x(transverse), y(vertical), and z (antero-posterior)planes. The positive directional movement of each point in X axis means the point moved left after surgery, and negative directional movement in X axis means the the point moved right after surgery. The positive directional movement in Y axis means the point moved upward after surgery, and negative directional movement in Y axis means the the point moved downward after surgery. The positive directional movement in Z axis means the point moved anteriorly after surgery, and negative directional movement in Z axis means the the point moved posteriorly after surgery."|The hard tissue movements were assessed after surgery 4-6 weeks.The soft tissue movements were assessed after surgery 6 months.|similar sex distribution in both groups (7 male and 17 female patients in Group C, and 8 male and 16 female patients in Group M)|||mm||Standard Deviation|Mean
2671913|NCT01473732|Primary|Change in eGFR (Creatinine Clearance) as Measured by Serum Creatinine Blood Test|Estimated glomerular filtration rate (eGFR) indicates kidney function. Normal eGFR value for healthy is 80-120ml/min. For transplants, it is expected to be 60-80 ml/min.|Baseline, One year|The only two patients enrolled did not reach the one year mark; they did not complete the study so there was no data to analyze.||||||
2671914|NCT01473602|Secondary|Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Overall Health Score|The EQ-5D is a 5-item, self-reported, generic, multidimensional, health-related, quality-of-life instrument with 5 items. Overall health state score was also self-reported using a visual analogue scale (VAS) marked on a scale scored from 0 (worst imaginable health state) to 100 (best imaginable health state). Higher scores represented better health state with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region.|Baseline, 6 Months|Participants who were randomized, received treatment, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.|||Units on a scale||Standard Error|Least Squares Mean
2672013|NCT01473407|Secondary|Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range|Percentage of participants who had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported.|Week 12, 24|ITT population included all participants who were randomized to study treatment.|||percentage of participants|||Number
2671915|NCT01473602|Secondary|Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)|WOMAC: was a self-reported questionnaire that consisted of 24 questions covering 3 health domains: Pain (5 items: during walking, using stairs, in bed, sitting or lying, and standing), Stiffness (2 items: after first waking and later in the day), and Physical Function. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 (best to worst) scale. Lower scores indicated better health status or functioning. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.|Baseline, up to 6 Months|Participants who were randomized, received treatment, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement..|||Units on a scale||Standard Error|Least Squares Mean
2671916|NCT01473602|Secondary|Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores|SF-12 is a self-reported questionnaire covering a mental component score (MCS) and a physical component score (PCS), each scoring from a 0 to 100 (worst to best) scale. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.|Baseline, 6 Months|Participants who were randomized, received treatment, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement..|||Units on a scale||Standard Error|Least Squares Mean
2671917|NCT01473602|Secondary|Time to Revision Surgery|Time to revision surgery was defined as the time from initial hip fracture surgery to revision surgery, or recommendation for revision surgery if recommended but not performed. Time to revision surgery was censored at the date of the last contact.|Baseline to Revision Surgery (up to 14.14 Months)|Participants who were randomized, received at least 1 dose of study drug, and who did not have revision surgery or if they had revision surgery, it was adjudicated as not being related to the initial hip fracture surgery. Participants censored: Teriparatide = 14; placebo = 19.|||Days||Full Range|Median
2671918|NCT01473602|Secondary|Mean Change From Baseline to 6 Months in Gait Speed|The walking test involved having the participant walk a distance of 7 m at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. LS means was calculated using ANCOVA adjusted for baseline, treatment group, region, fracture type, and fixation type|Baseline, 6 Months|Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 nonmissing post-baseline measurement.|||m/s||Standard Error|Least Squares Mean
2671919|NCT01473602|Secondary|Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain|The worst pain NRS was used to assess the impact of pain on a participant's life. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain. Least squares (LS) means was calculated using analysis of covariance (ANCOVA) adjusted for baseline, treatment group, region, fracture type, and fixation type.|Baseline, 6 Months|Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 nonmissing post-baseline measurement..|||Units on a scale||Standard Error|Least Squares Mean
2671920|NCT01473602|Secondary|Percentage of Participants Who Regained Their Prefracture Ambulatory Status|Prefracture ambulatory status was defined as either ambulatory with or without a walking aid. A participant was considered to have regained their prefracture ambulatory status if the participant's postsurgery ambulatory status was returned to or was improved from their pre-surgery ambulatory status. Percentage was calculated as = (number of participants who regained their ambulatory status / total number of participants analyzed) *100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug, and had baseline and at least one nonmissing post-baseline measurement. LOCF values used.|||Percentage of participants|||Number
2671921|NCT01473602|Secondary|Percentage of Participants Able to Ambulate|Ability to ambulate was defined as ambulatory with or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / total number of participants analyzed) * 100.|Up to 12 months|Participants who were randomized, received treatment and had at least 1 nonmissing post-baseline measurement. LOCF values used|||Percentage of participants|||Number
2671922|NCT01473602|Secondary|Percentage of Participants With Functional Evidence of Healing|"Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s.~Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) * 100."|Up to 12 Months|Participants who were randomized, received at least 1 dose of study drug, and had either at least one nonmissing gait speed or non-ambulatory status. LOCF values used.|||Percentage of participants|||Number
2671923|NCT01473602|Secondary|Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing|The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain on weight bearing. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 during weight bearing and no worsening of NRS score >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during weight bearing / total number of participants) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement. LOCF values used.|||Percentage of participants|||Number
2671924|NCT01473602|Secondary|Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit|The NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain in the 24 hours preceding a visit. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 in the 24 hours preceding a visit and no worsening of NRS score >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during 24 hours preceding a visit / total number of participants analyzed) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement for severe fracture-site pain in the last 24 hours.. LOCF values used.|||Percentage of participants|||Number
2672061|NCT01472874|Secondary|Cu Urine||Pre Treatment (mean)||||mcg/24hr||Standard Deviation|Mean
2672062|NCT01472874|Primary|Cu Serum||Months 1,2,3,6,9,12 (mean)||||mcg/24h||Standard Deviation|Mean
2671925|NCT01473602|Secondary|Percentage of Participants With Pain Control During Ambulation|The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life. NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test. Pain was measured by an 11-point Likert scale. The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain. Higher scores indicated more severe pain. Participants with an NRS score of <7 and no worsening of NRS scores >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during ambulation / total number of participants analyzed) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug, had baseline and at least 1 nonmissing post-baseline measurement. Last observation carried forward (LOCF) values used.|||Percentage of participants|||Number
2671926|NCT01473602|Secondary|Percentage of Participants With Radiographic Evidence of Healing|"The signs of femoral neck fracture healing and healing complications included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing.~Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) * 100."|Randomization up to 12 months|Participants who were randomized and received at least 1 dose of study drug.|||Percentage of participants|||Number
2671927|NCT01473602|Primary|Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture|Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.|12 months|Participants who were randomized, received at least 1 dose of study drug.|||Percentage of participants||90% Confidence Interval|Number
2671928|NCT01473589|Secondary|Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score|The EQ-5D is a 5-item, self-reported, generic, multidimensional, health-related, quality-of-life instrument with 5 items. Overall health state score was also self-reported using a visual analogue scale (VAS) marked on a scale scored from 0 (worse imaginable health state) to 100 (best imaginable health state). LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, and region.|Baseline, up to 6 Months|All randomized participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur, and had baseline and at least 1 nonmissing post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2671929|NCT01473589|Secondary|Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)|WOMAC is: a self-reported questionnaire that consisted of 24 questions covering 3 health domains: Pain (5 items: during walking, using stairs, in bed, sitting or lying, and standing), Stiffness (2 items: after first waking and later in the day), and Physical Function. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 (best to worst) scale. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.|Baseline, up to 6 Months|Participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2671930|NCT01473589|Secondary|Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores|SF-12 is a self-reported questionnaire covering a mental component score (MCS) and a physical component score (PCS), each scoring from a 0 to 100 (worst to best) scale. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.|Baseline, up to 6 Months|Participants who were randomized, received at least 1 dose of study drug, were adjudicated as having the hip fracture in the neck of the femur and had baseline and at least 1 nonmissing post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2671931|NCT01473589|Secondary|Time to Revision Surgery|Time to revision surgery was defined as the time from initial hip fracture surgery to revision surgery, or recommendation for revision surgery if recommended but not performed. Time to revision surgery was censored at the date of the last contact.|Baseline to revision surgery (up to 14.14 Months)|Participants who were randomized, received at least 1 dose of study drug, and who did not have revision surgery or if they had revision surgery, it was adjudicated as not being related to the initial hip fracture surgery. Participants censored: Teriparatide = 51; placebo = 51.|||days||Full Range|Median
2671932|NCT01473589|Secondary|Mean Change From Baseline to 6 Months in Gait Speed|The walking test involved having the participant walk a distance of 7 m at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. LS means was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, and fixation type.|Baseline, up to 6 Months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement.|||m/s||Standard Error|Least Squares Mean
2671933|NCT01473589|Secondary|Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain|The worst pain NRS was used to assess the impact of pain on a participant's life. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain. Least Squares (LS) means was calculated using analysis of covariance (ANCOVA) and adjusted for baseline, treatment group, region, fracture type, and fixation type.|Baseline, 6 Months|Participants who were randomized and received at least 1 dose of study drug and had baseline and at least 1 nonmissing post-baseline measurement.|||units on a scale||Standard Error|Least Squares Mean
2671934|NCT01473589|Secondary|Percentage of Participants Who Regain Their Prefracture Ambulatory Status|Prefracture ambulatory status was defined as either ambulatory with or without a walking aid. A participant was considered to have regained their prefracture ambulatory status if the participant's postsurgery ambulatory status was returned to or was improved from their pre-surgery ambulatory status. Percentage was calculated as = (number of participants who regained their ambulatory status / total number analyzed) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug, and had baseline and at least one nonmissing post-baseline measurement. LOCF values used.|||percentage of participants|||Number
2672063|NCT01472874|Primary|Cu Serum||Pre Treatment (mean)||||mcg/24h||Standard Deviation|Mean
2671937|NCT01473589|Secondary|Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing|The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain on weight bearing. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 during weight bearing and no worsening of NRS >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during weight bearing / total number of participants) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least 1 nonmissing post-baseline measurement. LOCF values used.|||percentage of participants|||Number
2671938|NCT01473589|Secondary|Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit|The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain in the 24 hours preceding a visit. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 in the 24 hours preceding a visit and no worsening of NRS >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during 24 hours preceding a visit / total number of participants) * 100.|Up to 12 months|Participants who were randomized, received at least 1 dose of study drug and had baseline and at least one nonmissing post-baseline measurement for severe fracture-site pain in the last 24 hours. LOCF values used.|||percentage of participants|||Number
2671939|NCT01473589|Secondary|Percentage of Participants With Pain Control During Ambulation|The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life. NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test. Pain was measured by an 11-point Likert scale. The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain with ambulation and no worsening of NRS scores >2 from baseline. Percentage was calculated as: (Number of participants with pain control during ambulation / total number of participants) * 100.|Up to 12 months|Participants who were randomized, received treatment, and had baseline and at least one nonmissing post-baseline measurement. Last observation carried forward (LOCF) values used.|||percentage of participants|||Number
2671940|NCT01473589|Secondary|Percentage of Participants With Radiographic Evidence of Healing|"The signs of femoral neck fracture healing included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing.~Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) * 100."|Randomization up to 12 months|Participants who were randomized and received at least 1 dose of study drug.|||percentage of participants|||Number
2671941|NCT01473589|Primary|Percentage of Participants With No Revision Surgery at 12 Months After Internal Fixation of a Low-Trauma Femoral Neck Fracture|Revision surgery (re-operation) was defined as any additional surgical intervention performed or recommended at the site of the index procedure, except those that were planned at the time of the index procedure.|12 months|Participants who were randomized and received at least 1 dose of study drug.|||percentage of participants||90% Confidence Interval|Number
2671942|NCT01473563|Secondary|Time to Treatment Failure (TTF)|The time from the date of the first dose of study treatment (Cycle 1, Day 1) to the date of death from any cause, PD (clinical and objective), or discontinuation of pemetrexed due to toxicity. Response was defined using RECIST, v1.1 criteria. PD was defined as having at least a 20% increase in the sum of the longest diameter of target lesions and at a minimum 5 mm increase above nadir. TTF was censored at the date of the last visit for participants who did not discontinue pemetrexed, who were still alive, and who had not progressed.|Cycle 1, Day 1 to first event (up to Cycle 19, 21 days/cycle)|ITT population: Participants who received at least 1 dose of study drug. Two (2) participants were censored.|||months||95% Confidence Interval|Median
2671943|NCT01473563|Secondary|Overall Survival (OS) at 6 Months|The percentage of participants who were alive at Month 6 was calculated as a cumulative percentage by Kaplan-Meier survival analyses approach. For participants not known to have died as of the cut-off date, OS was censored as the last contact date (known alive).|Cycle 1, Day 1 to the date of death from any cause (up to Month 6)|ITT population: Participants who received at least 1 dose of study drug. Twenty-four (24) participants were censored (alive) at the end of the study.|||percentage of participants||95% Confidence Interval|Number
2671944|NCT01473563|Secondary|Resource Utilization: Distances Traveled|The distance traveled is reported by region (Great Britain and Sweden) and includes the distance traveled by the participant from his/her home to the hospital (Cycle 1) and other cycles where the homecare nurse traveled from the hospital to the participant's home. Due to the limited number of participants with evaluable data, results are reported for Cycles 1 through 4.|Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 4, 21 days/cycle)|Participants who received at least 1 dose of study drug and had data for distance traveled for at least 1 cycle from Cycle 1 through Cycle 4.|||kilometers (km)||Standard Deviation|Mean
2671945|NCT01473563|Secondary|Resource Utilization: Duration of Health Care Visits|The duration of the health care visit in the home setting is reported. The visit started when the nurse arrived and included the entire treatment process. The visit ended when the nurse left the home setting. Due to the limited number of participants with evaluable data, results are reported for Cycles 2 through 4.|Cycle 2, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 4, 21 days/cycle)|Participants who received at least 1 dose of study drug and had at least 1 health care visit in the home setting from Cycle 2 through Cycle 4.|||hours||Standard Deviation|Mean
2671968|NCT01473420|Other Pre-specified|Percentage of Participants With Local Tolerability|Local tolerability was classified as: 1) excellent tolerability = no reaction at site of injection, 2) good tolerability = minimal reaction at site of injection normally observed with any kind of subcutaneous product, 3) mild intolerability = reaction at site of injection above that normally observed with any kind of subcutaneous product, 4) moderate intolerability = marked reaction, but no need for discontinuation of treatment and 5) severe intolerability = treatment discontinued due to intolerability.|Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38|"Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2671946|NCT01473563|Other Pre-specified|Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Died|The number of participants who had at least 1 TEAE or serious TEAE (regardless of causality) is reported along with the number of participants who died (due to any cause) while on therapy or during treatment discontinuation follow-up (up to 6 months). TEAEs started on or after the date and time of first dose of study drug, or started prior to study drug but worsened after study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.|First dose of study drug (Cycle 1, Day 1) through study completion [up to Cycle 19 (21 days/cycle) or treatment discontinuation, plus up to 6 months post treatment discontinuation]|Safety Population: Participants who received at least 1 dose of study drug.|||participants|||Number
2671947|NCT01473563|Secondary|Resource Utilization: Unplanned Health Care Visits, Consultations, and Diagnostic Services|The unplanned use of any 1 of the following 4 resources is reported, as well as the unplanned use of each resource: accident and emergency dept., specialists (oncologist, pulmonologist etc.), GP or family doctor, and diagnostic procedures. Results are reported as the number of participants with an unplanned resource use (visit) for a specified number of times.|Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 19, 21 days/cycle)|Participants who received at least 1 dose of study drug and had at least 1 unplanned use of health care resources.|||participants|||Number
2671948|NCT01473563|Secondary|Resource Utilization: Number of Participants With an Unplanned Use of Healthcare Resources|The number of participants who had at least 1 unplanned use of health care resources [accident and emergency department (dept.), specialists [oncologist, pulmonologist, etcetera (etc.)], general practitioner (GP) or family doctor, or diagnostic procedures] during the study is reported.|Cycle 1, Day 1 through last day of cycle when participant reverted to hospital administration or discontinued (up to Cycle 19, 21 days/cycle)|ITT population: Participants who received at least 1 dose of study drug.|||participants|||Number
2671949|NCT01473563|Secondary|Physician Satisfaction: Distant Management of Participant|"The physician was asked, How would you rate your overall satisfaction with the distant management of the participant during chemotherapy at home? Choices included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied."|30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and for whom the investigator answered the specified question at 30 days post treatment discontinuation.|||investigators|||Number
2671950|NCT01473563|Secondary|Participant Satisfaction: Preferences Regarding Home and/or Hospital Treatment|"Participants were asked to evaluate their preferences regarding home and/or hospital treatment delivery in this study by answering 2 questions (Q). Q15: Do you prefer having your chemotherapy at home or at the hospital, or are you indifferent? Choices included: Home, Hospital, or Indifferent. Q16: Would you recommend having chemotherapy at home to someone else in your same situation? Choices included: Yes, No, or Not sure."|The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.|||participants|||Number
2671951|NCT01473563|Secondary|Participant Satisfaction: Regarding the Study Nurse|"Participants were asked 7 questions (Q) about their study nurse for home treatment. Q8: Was the nurse an easy person to talk to?, Q9: When the nurse came, did you feel he/she had enough time to do the required things?, Q10: Do you think the nurse had time to discuss things with you?, Q11: Did you feel that the nurse knew enough about you and your illness? Choices for Q8 through Q11 included: Yes or No. Q12: Were you able to get all the information you wanted about your illness or treatment? Choices included: Yes, No, or Uncertain. Q13: Would you say that the nurse gave… Choices included: a lot of reassurance and support, some reassurance and support, or hardly any reassurance and support. Q14: How would you rate your overall satisfaction with the nursing staff during chemotherapy at home? Choices included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied."|The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.|||participants|||Number
2671952|NCT01473563|Secondary|Participant Satisfaction: Chemotherapy at Home|"Participants were asked to evaluate their home treatment experiences in this study by answering 4 questions (Q). Q5: What do you do consider advantages of having chemotherapy at home? Choose all that apply. Choices included: No need to travel, Not having to wait for treatment, Personalized service, More privacy, and Other. Q6:What do you consider disadvantages of having chemotherapy at home? Choose all that apply. Choices included: Lack of other patients' support, Extra burden for family/friends, Safety concerns, Need to rely on 1 medical specialist, and Other. Q7: How would you rate your overall satisfaction with chemotherapy at home? Choices included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied."|The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.|||participants|||Number
2671953|NCT01473563|Secondary|Participant Satisfaction: Chemotherapy at Hospital|"Participants were asked to evaluate their hospital experiences in this study by answering 4 questions (Q). Q1: What do you consider advantages of having chemotherapy at the hospital? Choose all that apply. Choices included: Support from other patients, Access to other medical specialists, Access to more technical services, Safer in case something goes wrong, and Other. Q2: What do you consider disadvantages of having chemotherapy at the hospital? Choose all that apply. Choices included: Need to travel, Having to wait for treatment, Not having a personalized treatment, Lack of privacy on the ward, and Other. Q3: How would you rate your overall satisfaction with chemotherapy at the hospital? and Q4: How would you rate your overall satisfaction with the nursing staff during chemotherapy at the hospital? Choices for Q3 and Q4 included: Very dissatisfied, Somewhat dissatisfied, Neither satisfied nor dissatisfied, Somewhat satisfied, or Very satisfied."|The first evaluation completed at either Cycle 4, Day 1 (21 days/cycle) or 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and answered at least 1 of the specified questions.|||participants|||Number
2672064|NCT01472874|Secondary|Albumin||Months 1,2,3,6,9,12 (mean)||||g/dL||Standard Deviation|Mean
2671954|NCT01473563|Secondary|Maximum Improvement Over Baseline in Individual Lung Cancer Symptoms Scale (LCSS) Item Scores|LCSS is a 9-item questionnaire; 6 items are symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items describe overall symptomatic distress, interference with activity level, and overall quality of life during the past 24 hours. Participant responses were measured using a VAS with 100-millimeter (mm) lines. Scores ranged from 0 mm (no symptoms and no impact on activities, quality of life) to 100 mm (symptoms as bad as they could be, impacting activities and quality of life).|Baseline, Day 1 of each cycle (up to Cycle 19, 21 days/cycle), and 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline LCSS assessment.|||mm||Standard Deviation|Mean
2671955|NCT01473563|Secondary|Change From Baseline in the EQ-5D Index Score|The EQ-5D scale was used to provide an estimate of the health state utility in this population. The EQ-5D scale includes a 5-dimensional descriptive system that measures each of the health state attributes: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression according to a 3-point scale (no problem, some problems, and major problems) and a VAS that allows participants to rate their present health condition from 0 (worst imaginable health state) to 100 (best imaginable health state). The change from baseline EQ-5D Index score is reported and the EQ-5D Index score was calculated by converting health state scores into a weighted health state index according to a United Kingdom population-based algorithm. The possible values for the EQ-5D Index score range from −0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension), on a scale where 1 represents the best possible health state.|Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline EQ-5D index assessment.|||units on a scale||Standard Deviation|Mean
2671956|NCT01473563|Secondary|Change From Baseline in the European Quality of Life Instrument (EQ-5D) Visual Analogue Scale (VAS)|The EQ-5D scale was used to provide an estimate of the health state utility in this population. The EQ-5D scale includes a 5-dimensional descriptive system that measures each of the health state attributes: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression according to a 3-point scale (no problem, some problems, and major problems) and a VAS that allows participants to rate their present health condition from 0 (worst imaginable health state) to 100 (best imaginable health state). The change from baseline in EQ-5D VAS is reported.|Baseline, Day 1 of Cycles 2 and 4 (21 days/cycle) and 30 days post treatment discontinuation|Participants who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline EQ-5D VAS assessment.|||units on a scale||Standard Deviation|Mean
2671957|NCT01473563|Primary|Percentage of Participants Who Adhered to Treatment Administration at Home|Participants were considered adherent from the time of the first dose in Cycle 1 (hospital administration) until either the last day of the cycle when the participant reverted to pemetrexed hospital administration or the last day of the cycle when the participant discontinued study treatment or the study for reasons related to the home setting. The percentage of participants who adhered to treatment administration at home was estimated by a Kaplan-Meier survival analyses approach. Participants who died or discontinued the study and treatment without reverting to hospital administration were censored at the time of discontinuation.|Cycle 1, Day 1 through Cycle 19, Day 1 and Cycle 19, Day 1 (21 days/cycle)|Intention-to-Treat (ITT) population: Participants who received at least 1 dose of study drug. The number of participants censored was 6, 9, 7, 8, 7, 1, 0, 2, 2, 2, 2, 0, 3, 0, 0, 0, 0, 0, and 1 for Cycles 1 through 19, respectively.|||percentage of participants||95% Confidence Interval|Number
2671958|NCT01473524|Secondary|Gamma-glutamyltransferase (GGT) Absolute Change From Baseline to Month 12|Gamma-glutamyltransferase (GGT) Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population|||U/L||Standard Error|Least Squares Mean
2671959|NCT01473524|Secondary|Aspartate Aminotransferase (AST) Absolute Change From Baseline to Month 12|Aspartate Aminotransferase (AST) Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population|||U/L||Standard Error|Least Squares Mean
2671960|NCT01473524|Secondary|Alanine Aminotransferase (ALT) Absolute Change From Baseline to Month 12|Alanine Aminotransferase (ALT) Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population|||U/L||Standard Error|Least Squares Mean
2671961|NCT01473524|Secondary|Direct Bilirubin Absolute Change From Baseline to Month 12|Direct Bilirubin Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population|||umol/L||Standard Error|Least Squares Mean
2671962|NCT01473524|Secondary|Total Bilirubin Absolute Change From Baseline to Month 12|Total Bilirubin Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population|||umol/L||Standard Error|Least Squares Mean
2671963|NCT01473524|Secondary|Alkaline Phosphatase Absolute Change From Baseline to Month 12|Alkaline Phosphatase Absolute Change from Baseline to Month 12|12 months|Intent-to-Treat Population|||U/L||Standard Error|Least Squares Mean
2671964|NCT01473524|Secondary|Composite Endpoint Alkaline Phosphatase and Total Bilirubin, 5-10 mg vs. Placebo|Proportion of subjects at Month 6 with ALP < 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.|6 Months|Intent-to-Treat Population|||percentage of participants|||Number
2671965|NCT01473524|Secondary|Composite Endpoint Alkaline Phosphatase and Total Bilirubin, 5-10 mg vs. Placebo|Proportion of subjects at Month 12 with ALP < 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.|12 Months|Intent-to-Treat Population|||percentage of participants|||Number
2671966|NCT01473524|Secondary|Composite Endpoint Alkaline Phosphatase and Total Bilirubin, 10 mg vs. Placebo|Proportion of subjects at Month 6 with ALP < 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.|6 months|Intent-to-Treat Population|||percentage of participants|||Number
2671967|NCT01473524|Primary|Composite Endpoint Alkaline Phosphatase and Total Bilirubin, 10 mg OCA vs. Placebo|Proportion of subjects at Month 12 with ALP < 1.67x ULN and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.|12 months|Intent-to-Treat Population|||percentage of participants|||Number
2671993|NCT01473420|Primary|Mean Weekly Dosage of Study Medication From Week 30 to Week 34: Maintenance Period||Week 30 up to Week 34|This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.|||unit per kilogram per week (U/kg/week)||Standard Deviation|Mean
2672065|NCT01472874|Secondary|Albumin||Pre Treatment (mean)||||g/dL||Standard Deviation|Mean
2671969|NCT01473420|Other Pre-specified|Percentage of Participants With General Tolerability|General tolerability was classified as: 1) excellent tolerability = no reaction, 2) good tolerability = minimal reaction, 3) mild intolerability = reaction above that normally observed with any kind of subcutaneous product, 4) moderate intolerability = marked reaction, but no need for discontinuation of treatment and 5) severe intolerability = treatment discontinued due to intolerability.|Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38|"Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2671970|NCT01473420|Other Pre-specified|Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies|Percentage of participants with presence of anti-rhEPO antibodies were reported in this outcome measure. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies.|Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38|"Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2671971|NCT01473420|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Physical Examination|Physical examination included examination of the following: skin, eyes, ears, throat, cardiac, respiratory, gastrointestinal, genitourinary and musculoskeletal systems. Participants with clinically significant change from baseline in physical examination were as determined by the investigator.|Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2671972|NCT01473420|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)|ECG parameters: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in ECG were as determined by the investigator.|Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2671973|NCT01473420|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital sign parameters: temperature (oral, tympanic, or other), blood pressure (diastolic and systolic), heart rate (in a seated position) and dry weight (post-dialysis). Participants with clinically significant change from baseline in vital signs were as determined by the investigator.|Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2671974|NCT01473420|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters|Laboratory parameters: Hematology (hematocrit, hemoglobin, red blood cell count, reticulocytes, white blood cell count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelet count, mean corpuscular volume); coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); clinical chemistry (blood urea nitrogen, creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, gamma-glutamyl transpeptidase, alkaline phosphatase, sodium, potassium, calcium, magnesium, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein, plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory parameters were as determined by the investigator.|Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2671975|NCT01473420|Other Pre-specified|Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event|In this outcome measure number of participants discontinued from study drug (Epoetin Hospira, Epogen) due to any AE were reported.|Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38|"Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2671976|NCT01473420|Other Pre-specified|Number of Participants With Treatment Related Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant who received study drug.|Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38|"Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2671977|NCT01473420|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An AE was assessed according to severity; mild (AE was transient and easily tolerated by the participant), moderate (caused problem that did not interfere significantly with usual activities) and severe (caused problem that interferes significantly with usual activities and might be incapacitating or life-threatening).|Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38|"Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2671994|NCT01473420|Primary|Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period||Week 30 up to Week 34|This outcome measure was planned not to be analyzed in titration period. Intent-to-treat (ITT) population included all participants who were randomized into the maintenance period.|||g/dL||Standard Deviation|Mean
2671995|NCT01473407|Other Pre-specified|Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies|Percentage of participants with presence of anti-rhEPO antibodies were reported in this outcome measure. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies.|Week 1 up to Week 28|Safety population included all participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
2671978|NCT01473420|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.|Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2671979|NCT01473420|Other Pre-specified|Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL): Maintenance Period||Week 19 up to Week 34|This outcome measure was planned not to be analyzed in titration period. Safety analysis population for maintenance period included all participants who received at least 1 dose of study treatment in maintenance period.|||percentage of participants|||Number
2671980|NCT01473420|Other Pre-specified|Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL): Maintenance Period||Week 19 up to Week 34|This outcome measure was planned not to be analyzed in titration period. Safety analysis population for maintenance period included all participants who received at least 1 dose of study treatment in maintenance period.|||percentage of participants|||Number
2671981|NCT01473420|Secondary|Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level: Maintenance Period||Week 19 up to Week 34|This outcome measure was planned not to be analyzed in titration period. Safety analysis population for maintenance period included all participants who received at least 1 dose of study treatment in maintenance period.|||percentage of participants|||Number
2671982|NCT01473420|Secondary|Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period|In this outcome measure number of participants with change (increase and decrease) in mean dose of Epoetin Hospira and Epogen were categorized and reported according to their mean hemoglobin levels. Hemoglobin levels were divided in following classes: >11.0 g/dL, from 9.0 to 11.0 g/dL and <9.0 g/dL|Week 19 up to Week 34|"This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, N signifies those participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2671983|NCT01473420|Secondary|Percentage of Participants Who Received Blood Transfusions: Maintenance Period||Week 19 up to Week 34|This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.|||percentage of participants|||Number
2671984|NCT01473420|Secondary|Percentage of Participants Who Qualified as Optimally Titrated and Stable: Titration Period||Week 1 up to Week 18|This outcome measure was planned not to be analyzed in maintenance period. Safety analysis population for titration period included all participants who received at least 1 dose of study treatment in titration period.|||percentage of participants|||Number
2671985|NCT01473420|Secondary|Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range: Maintenance Period|Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported.|Week 26, 34|This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.|||percentage of participants|||Number
2671986|NCT01473420|Secondary|Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1.0 Gram Per Deciliter (g/dL): Maintenance Period||Week 19 up to Week 34|This outcome measure was planned not to be analyzed in titration period. Per protocol population included all participants who were randomized into the maintenance period and who did not have major protocol violations.|||percentage of participants|||Number
2671987|NCT01473420|Secondary|Percentage of Participants Who Required Temporary Dose Changes: Maintenance Period||Week 19 up to Week 34|This outcome measure was planned not to be analyzed in titration period. Per protocol population included all participants who were randomized into the maintenance period and who did not have major protocol violations.|||percentage of participants|||Number
2671988|NCT01473420|Secondary|Percentage of Participants Who Required Permanent Dose Changes: Maintenance Period||Week 19 up to Week 34|This outcome measure was planned not to be analyzed in titration period. Per protocol population included all participants who were randomized into the maintenance period and who did not have major protocol violations.|||percentage of participants|||Number
2671989|NCT01473420|Secondary|Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range: Maintenance Period|Percentage of participants who had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported.|Week 26, 34|This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period.|||percentage of participants|||Number
2671990|NCT01473420|Secondary|Total Dose of Study Medication Administered: Maintenance Period|In this outcome measure mean of total dose of study medication administered in maintenance period was reported.|Week 19 up to Week 34|"This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, N signifies number of participants who were evaluable for this outcome measure."|||units of study medication||Standard Deviation|Mean
2671991|NCT01473420|Secondary|Mean Weekly Dosage of Study Medication From Week 19 to Week 34: Maintenance Period||Week 19 up to Week 34|"This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, N signifies number of participants who were evaluable for this outcome measure."|||U/kg/week||Standard Deviation|Mean
2671992|NCT01473420|Secondary|Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period||Week 19 up to Week 34|"This outcome measure was planned not to be analyzed in titration period. ITT population included all participants who were randomized into the maintenance period. Here, Number of Participants Analyzed (N) signifies number of participants who were evaluable for this outcome measure."|||g/dL||Standard Deviation|Mean
2671998|NCT01473407|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital sign parameters: temperature (oral, tympanic, or other), blood pressure (diastolic and systolic), heart rate (in a seated position) and dry weight (post-dialysis). Participants with clinically significant change from baseline in vital signs were as determined by the investigator.|Baseline up to Week 28|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2671999|NCT01473407|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters|Laboratory parameters: Hematology (hematocrit, hemoglobin, red blood cell count, reticulocytes, white blood cell count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelet count, mean corpuscular volume); coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); clinical chemistry (blood urea nitrogen, creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, gamma-glutamyl transpeptidase, alkaline phosphatase, sodium, potassium, calcium, magnesium, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein, plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory parameters were as determined by the investigator.|Baseline up to Week 28|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2672000|NCT01473407|Other Pre-specified|Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event|In this outcome measure number of participants who discontinued from study drug (Epoetin Hospira, Epogen) due to any AE were reported.|Week 1 up to Week 28|"Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2672001|NCT01473407|Other Pre-specified|Number of Participants With Treatment Related Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.|Week 1 up to Week 28|"Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2672002|NCT01473407|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug to the end of study (up to Week 28) that were absent before treatment or that worsened relative to pre-treatment state. An AE was assessed according to severity; mild (AE was transient and easily tolerated by the participant), moderate (caused problem that did not interfere significantly with usual activities) and severe (caused problem that interferes significantly with usual activities and might be incapacitating or life-threatening).|Week 1 up to Week 28|"Safety population included all participants who received at least 1 dose of study treatment. Here, N signifies those participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2672003|NCT01473407|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events from first dose of study drug to the end of study (up to Week 28) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.|Week 1 up to Week 28|Safety population included all participants who received at least 1 dose of study treatment.|||Participants|||Count of Participants
2672004|NCT01473407|Other Pre-specified|Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)||Week 1 up to Week 24|Safety population included all participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
2672005|NCT01473407|Other Pre-specified|Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)||Week 1 up to Week 24|Safety population included all participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
2672006|NCT01473407|Secondary|Percentage of Participants With Any Transient Change of Hemoglobin Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level||Week 1 up to Week 24|Safety population included all participants who received at least 1 dose of study treatment.|||percentage of participants|||Number
2672007|NCT01473407|Secondary|Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level|In this outcome measure number of participants with change (increase and decrease) in mean dose of Epoetin Hospira and Epogen were categorized and reported according to their mean hemoglobin levels. Hemoglobin levels were divided in following classes: >11.0 g/dL, from 9.0 to 11.0 g/dL and <9.0 g/dL|Week 1 up to Week 24|"ITT population included all participants who were randomized to study treatment. Here, N signifies number of participants who were evaluable for this outcome measure."|||Participants|||Count of Participants
2672008|NCT01473407|Secondary|Percentage of Participants Who Received Blood Transfusions||Week 1 up to Week 24|"ITT population included all participants who were randomized to study treatment. Here, N signifies number of participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2672009|NCT01473407|Secondary|Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range|Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported.|Week 12, 24|ITT population included all participants who were randomized to study treatment.|||percentage of participants|||Number
2672010|NCT01473407|Secondary|Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1 Gram Per Deciliter (g/dL)||Week 1 up to Week 24|Per protocol population was a subset of ITT participants who did not have major protocol violations.|||percentage of participants|||Number
2672011|NCT01473407|Secondary|Percentage of Participants Who Required Temporary Dose Changes of Study Medication||Week 1 up to Week 24|Per protocol population was a subset of ITT participants who did not have major protocol violations.|||percentage of participants|||Number
2672094|NCT01472549|Secondary|Number of Participants With Skin Contamination After Skin Prep||1 day|The skin samples collected could not be processed for financial reasons.||||||
2672016|NCT01473407|Secondary|Mean Weekly Hemoglobin Level Through 24 Weeks||Week 1 up to Week 24|"ITT population included all participants who were randomized to study treatment. Here, N signifies number of participants who were evaluable for this outcome measure."|||g/dL||Standard Deviation|Mean
2672017|NCT01473407|Primary|Mean Weekly Dosage of Study Medication From Week 21 to Week 24||Week 21 up to Week 24|"ITT population included all participants who were randomized to study treatment. Here, Number of Participants Analyzed (N) signifies those participants who were evaluable for this outcome measure."|||unit per kilogram per week (U/kg/week)||Standard Deviation|Mean
2672018|NCT01473407|Primary|Mean Weekly Hemoglobin Level From Week 21 to Week 24||Week 21 up to Week 24|ITT population included all participants who were randomized to study treatment.|||g/dL||Standard Deviation|Mean
2672019|NCT01473394|Secondary|Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response Rate|The MADRS Sustained response rate is defined as a MÅDRS total score ≤ 12 for at least the last 2 consecutive visits during the double-blind treatment period.|Baseline to Week 8|Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product and who had a Baseline and at least 1 post-baseline assessment of the MADRS total score.|||Percentage of participants||95% Confidence Interval|Number
2672020|NCT01473394|Secondary|Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Score at Week 8|"The CGI-S is a clinician-rated scale for assessing the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. The clinician responded to the following question Considering your total clinical experience with this population, how mentally ill is the participant at this time? on a 7-point scale: 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The scale ranges from 1 to 7. A higher score indicates more severe mental illness. A negative change score indicates improvement."|Baseline to Week 8|Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product and who had a Baseline and at least 1 post-baseline assessment of the MADRS total score.|||Units on a scale||Standard Error|Least Squares Mean
2672021|NCT01473394|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8|The MADRS is a clinician-rated scale for assessing depressive symptomatology that had occurred in participants during the week preceding each interview. Patients were rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores on the 10 items and ranged from 0 to 60. A higher score indicated more depressive symptomatology. A negative change score indicated improvement.|Baseline to Week 8|Intent-to-treat population: All randomized participants who received at least 1 dose of double-blind investigational product and who had a Baseline and at least 1 post-baseline assessment of the MADRS total score.|||Units on a scale||Standard Error|Least Squares Mean
2672022|NCT01473381|Secondary|Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response|The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A MADRS sustained response was defined as a MADRS total score ≤ 12 for at least the last 2 visits during the double-blind treatment period (Weeks 1-10). A total MADRS score ≤ 12 corresponds to an average score of 1 per item and is indicative of very low level of depressive symptoms.|Baseline to Week 10|Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.|||Percentage of participants||95% Confidence Interval|Number
2672023|NCT01473381|Secondary|Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score|"The Clinical Global Impressions-Severity scale is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. In particular, the clinician is asked to respond to the following question: Considering your total clinical experience with this population, how mentally ill is the patient at this time? The patient is rated on the following 7-point scale: 1-normal, not at all ill, 2-borderline ill, 3-mildly ill, 4-moderately ill, 5-markedly ill, 6-severely ill, 7-among the most extremely ill patients. A higher score indicates more mental illness. A negative change score indicates improvement."|Baseline to Week 10|Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.|||Units on a scale||Standard Error|Least Squares Mean
2672024|NCT01473381|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10|The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A negative change score indicates improvement.|Baseline to Week 10|Intent-to-treat population: All randomized participants who received at least 1 dose of placebo, vilazodone, or citalopram and who had a baseline and at least 1 post-baseline assessment of the MADRS total score.|||Units on a scale||Standard Error|Least Squares Mean
2672025|NCT01473368|Primary|Operational Taxonomic Units|"Core Microbiome includes control samples and baseline samples (Day -7 and Day 0) for antibiotic, probiotic, and combination groups. Data for Core microbiome for individual arms are not available.~Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21"|Day 0 to Day 21||||units||Standard Deviation|Mean
2672026|NCT01473368|Primary|Prevalence of Escherichia in Stool|"Control arm was not assessed as there was no intervention for this group.~Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21"|Day -7 to Day 21||||percentage of total bacteria||Standard Deviation|Mean
2672027|NCT01473368|Primary|Prevalence of Escherichia in Stool|"Control arm was not assessed as there was no intervention for this group.~Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21"|Day -7 to Day 21||||percentage of total bacteria||Standard Deviation|Mean
2672028|NCT01473368|Primary|Prevalence of Escherichia in Stool|"Control arm was not assessed as there was no intervention for this group.~Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21"|Day -7 to Day 21||||percentage of total bacteria||Standard Deviation|Mean
2672029|NCT01473368|Primary|Gastrointestinal Symptoms Response Scale|Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms|Day 21|Participants analyzed were those with complete data at Day 14|||units on a scale||Standard Deviation|Mean
2672030|NCT01473368|Primary|Gastrointestinal Symptoms Response Score|Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms|Day 14|Participants analyzed were those with complete data at Day 14|||units on a scale||Standard Deviation|Mean
2672031|NCT01473368|Primary|Gastrointestinal Symptom Rating Scale|Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms|Day 7||||Units on a scale||Standard Deviation|Mean
2672032|NCT01473368|Primary|Gastrointestinal Symptom Rating Scale|Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms|Day 0|Control participants were not assessed at this time point.|||units on a scale||Standard Deviation|Mean
2672033|NCT01473355|Secondary|Presence of Plaque|Occurence of plaque around the study implant. Presented as number of implants that show presence of plaque at time of the 3 years follow-up visit after implant loading.|Measured at the 3 year follow-up after implant loading.|39 subjects (65 implants) completed the 3-year follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 34 subjects (60 implants) for the plaque analysis.|||Implants|Implants||Count of Units
2672034|NCT01473355|Secondary|Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP|Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as % of implants that show presence of bleeding on probing at time of the 3-year follow-up visit.|Measured at the 3 year follow-up after implant loading.|39 subjects (65 implants) completed the 3-year follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 34 subjects (60 implants) for the BoP analysis.|||Implants|Implants||Count of Units
2672035|NCT01473355|Secondary|Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD|"Condition of the periimplant mucosa by assessment of probing pocket depth (PPD).~Change in pocket depth expressed in millimeters at the 3-year follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline).~Negative value = increased pocket depth."|Measured at the 3 year follow-up after implant loading.|39 subjects (65 implants) completed the 3-year follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 34 subjects (60 implants) for the PPD analysis.|||millimeter|Implants|Standard Deviation|Mean
2672036|NCT01473355|Secondary|Number of Stable Implants|Implant stability evaluated clinically/manually (recorded as stable yes/no).|Measured at the 3 year follow-up after implant loading.|39 subjects (65 implants) completed the 3-year follow-up visit. Analysis of implant stability was performed on the all patients treated population.|||Implants|Implants||Count of Units
2672037|NCT01473355|Secondary|Marginal Bone Level Alteration|Marginal bone level determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 3 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).|Measured at the 3 year follow-up after implant loading.|39 subjects (65 implants) completed the 3-year follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 34 subjects (60 implants). Three of the radiographs were not possible to evaluate, giving an overall number of 32 subjects (57 implants) as basis for the Marginal Bone Level analysis.|||millimeter|Implants|Standard Deviation|Mean
2672038|NCT01473355|Primary|Number of Survived Implants|Implant survival rate evaluated by clinically and radiographically counting the number of implants remaining in function|Measured at the 3 year follow-up after implant loading.|All participants treated with at least one study implant.|||Implants|Implants||Count of Units
2672039|NCT01473160|Secondary|Number of Participants With Adequate Lens Fit|Lens fit was assessed by the investigator with a biomicroscope (slit lamp).|Up to 16 hours after lens insertion|All enrolled participants|||Participants|||Number
2672040|NCT01473160|Secondary|Subjective Vision|"Overall vision was assessed by the participant on scale from 0 (poor) to 10 (excellent) in response to the question, What is the quality of your vision with the lens at present?"|Up to 16 hours after lens insertion|All enrolled participants|||Units on a scale||Standard Deviation|Mean
2672041|NCT01473160|Secondary|Subjective Comfort|"Overall comfort was assessed by the participant and recorded on a scale from 0 (poor) to 10 (excellent) in response to the question, How comfortable is the lens feeling at present?"|Up to 16 hours after lens insertion|All enrolled participants|||Units on a scale||Standard Deviation|Mean
2672042|NCT01473160|Primary|Average Ocular Surface Temperature|Ocular surface temperature (OST) was recorded by the investigator using a dynamic, non-contact, infrared thermography camera. The average OST (encompassing the wear of a contact lens) was taken at the center of the cornea, at the temporal upper limbal area, and over the central 5 mm2 of the cornea, 2 seconds post-blink.|Up to 16 hours after lens insertion|All enrolled participants|||Degrees Celsius||Standard Deviation|Mean
2672043|NCT01473160|Primary|Average Tear Meniscus Height|The tear meniscus height, i.e., the distance between the line of reflection along the top of the tear prism to the edge of the eyelid, was measured by the investigator using a digital slit lamp.|Up to 16 hours after lens insertion|All enrolled participants|||pixels||Standard Deviation|Mean
2672095|NCT01472549|Secondary|Number of Participants With Allergic Reaction||30 days||||Participants|||Count of Participants
2672044|NCT01473160|Primary|Pre-Lens Noninvasive Tear Break-Up Time|The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a lengthening in the tear film break up time.|Up to 16 hours after lens insertion|All enrolled participants|||seconds||Standard Deviation|Mean
2672045|NCT01473160|Primary|Number of Participants With Corrected Visual Acuity of 0.0 or Better|Corrected visual acuity was measured with a digitized logMAR (logarithm of the minimum angle of resolution) chart. A logMAR acuity of 0.0 is considered normal distance eyesight.|Up to 16 hours after lens insertion|All enrolled participants|||participants|||Number
2672046|NCT01472965|Secondary|Adverse Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone|Adverse events attributable to lock therapy or related to the central venous access device (CVAD) were elicited from direct questioning at study visits and from the medical record. The percentage of evaluable participants with any potentially attributable adverse effect is reported.|Up to 37.5 weeks after the start of treatment.||||percentage of participants|||Number
2672047|NCT01472965|Secondary|Rate of Central Venous Access Device (CVAD) Occlusion Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone|Occlusion was defined as central line occlusion or dysfunction requiring thrombolytic therapy. The percentage of evaluable participants requiring thrombolytic therapy for central line occlusion is reported.|Up to 26 weeks after the start of treatment.||||percentage of participants|||Number
2672048|NCT01472965|Secondary|Cumulative Incidence of Reinfection in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone|Reinfection was defined as new CLABSI with a different organism occurring during the 24 week prophylaxis phase. The percentage of evaluable participants with reinfection is reported.|Up to 25 weeks after the start of treatment.||||percentage of participants|||Number
2672049|NCT01472965|Secondary|Cumulative Incidence of Relapse in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone|Relapse was defined as new CLABSI with an identical organism occurring during the 24 week prophylaxis phase. The percentage of evaluable participants with relapse is reported.|Up to 25 weeks after the start of treatment||||percentage of participants|||Number
2672050|NCT01472965|Secondary|Cumulative Incidence of Therapeutic Failure in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone|Therapeutic failure was a pre-defined composite outcome comprising either 'early failure': central line removal, death, persistent positive blood cultures for >72 hours, development of new CLABSI, or initiation of other ALT) during the 5 day treatment phase, or 'late failure': relapse (new CLABSI with an identical organism), or reinfection (new CLABSI with a different organism) during the 24 week prophylaxis phase. The cumulative incidence of therapeutic failure is reported.|Up to 25 weeks after the start of treatment||||percentage of participants|||Number
2672051|NCT01472965|Primary|Percentage of Therapeutic Failures (Early or Late Failure) in Children and Adolescents With CLABSI Receiving Standard Care Plus Ethanol Lock Therapy (ELT) vs. Standard Care Alone|Therapeutic failure was a pre-defined composite outcome comprising either 'early failure': central line removal, death, persistent positive blood cultures for >72 hours, development of new CLABSI, or initiation of other ALT) during the 5 day treatment phase, or 'late failure': relapse (new CLABSI with an identical organism), or reinfection (new CLABSI with a different organism) during the 24 week prophylaxis phase. The percentage of evaluable participants with therapeutic failure is reported.|Up to 25 weeks after the start of treatment.||||percentage of participants|||Number
2672052|NCT01472939|Secondary|Time to Maximum Plasma Concentration (Tmax) of SSP-002358||Over 8 hours post-dose (week 2 or later)|Full Pharmacokinetic Subset consisted of a subset of subjects who underwent the detailed pharmacokinetic assessments. Subjects who vomited within the blood sampling period may have been excluded.|||hours||Full Range|Median
2672053|NCT01472939|Secondary|Steady State Maximum Plasma Concentration (Cmax) of SSP-002358|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered.|Over 8 hours post-dose (week 2 or later)|Full Pharmacokinetic Subset consisted of a subset of subjects who underwent the detailed pharmacokinetic assessments. Subjects who vomited within the blood sampling period may have been excluded.|||pg/ml||Standard Deviation|Mean
2672054|NCT01472939|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of SSP-002358|Area under the plasma concentration versus time curve can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Over 8 hours post-dose (week 2 or later)|Full Pharmacokinetic Subset consisted of a subset of subjects who underwent the detailed pharmacokinetic assessments. Subjects who vomited within the blood sampling period may have been excluded.|||pg*h/ml||Standard Deviation|Mean
2672055|NCT01472939|Secondary|Change From Baseline in the Persistent Reflux Integrated Symptom Measurement (PRISM) Liquid and Food Domain Scores Over Weeks 5-8|PRISM is a 21 item patient-reported outcome instrument with 4 domains. Items are scored using various scales. Total score ranges from 0-100. Higher scores indicate more severe or frequent symptoms.|Baseline and over weeks 5-8|Full Analysis Set consisted of all subjects in the Safety Analysis Set who had at least 1 post-baseline value for the primary efficacy assessment. Safety Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||units on a scale||Standard Error|Least Squares Mean
2672056|NCT01472939|Secondary|Change From Baseline in Heartburn-Free Days Over Weeks 5-8||Baseline and over weeks 5-8|Full Analysis Set consisted of all subjects in the Safety Analysis Set who had at least 1 post-baseline value for the primary efficacy assessment. Safety Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||percentage of days||Standard Error|Least Squares Mean
2672057|NCT01472939|Primary|Change From Baseline in Percent Regurgitation-Free Days Over Weeks 5-8||Baseline and over weeks 5-8|Full Analysis Set consisted of all subjects in the Safety Analysis Set who had at least 1 post-baseline value for the primary efficacy assessment. Safety Analysis Set consisted of all randomized subjects who took at least 1 dose of investigational product.|||percentage of days||Standard Error|Least Squares Mean
2672058|NCT01472874|Secondary|Zn Urine||Months 1,2,3,6,9,12 (mean)||||mcg/24hr||Standard Deviation|Mean
2672066|NCT01472874|Secondary|INR|The International Normalized Ratio (INR) is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy|Months 1,2,3,6,9,12 (mean)||||international normalized ratio||Standard Deviation|Mean
2672067|NCT01472874|Secondary|INR|The International Normalized Ratio (INR) is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy|Pre Treatment (mean)||||international normalized ratio||Standard Deviation|Mean
2672068|NCT01472874|Primary|ALT|Alanine transaminase|Months 1,2,3,6,9,12 (mean)||||U/L||Standard Deviation|Mean
2672069|NCT01472874|Primary|ALT|Alanine transaminase|Pre Treatment (mean)||||U/L||Standard Deviation|Mean
2672070|NCT01472835|Secondary|Satisfaction|5-point Likert scale. The scale is from 1-5. 1 being very unsatisfied and 5 being very satisfied.|1 day||||units on a scale||Standard Deviation|Mean
2672071|NCT01472835|Secondary|Oswestry Disability Index|Measure of functional capacity on a scale ranging from 0% to 100%, with 0% signifying no disability|1-month||||units on a scale||Standard Deviation|Mean
2672072|NCT01472835|Secondary|Procedure-related Pain Score|0-10 pain scale, with 0 being no pain and 10 being the worst pain imaginable|1 day||||units on a scale||Standard Deviation|Mean
2672073|NCT01472835|Secondary|Pain Score|0-10 numerical rating scale (NRS) pain scale. 0 being no pain and 10 being the worst possible pain.|1-month||||units on a scale||Standard Deviation|Mean
2672074|NCT01472835|Primary|Pain Score|pain diary using 0-10 scale, with 0 being no pain and 10 being the worst pain imaginable|through 6 hours after injection||||units on a scale||Standard Deviation|Mean
2672075|NCT01472822|Secondary|Changes in DPD(Deoxypyridinoline)|DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||nanoMolar DPD per milliMolar creatine||Standard Deviation|Mean
2672076|NCT01472822|Secondary|Changes in OSC(Osteocalcin)|OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||ng/ml||Standard Deviation|Mean
2672077|NCT01472822|Secondary|Changes in Hs-CRP(High Sensitivity C-reactive Protein)|hs-CRP(high sensitivity C-reactive protein) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||mg/L||Standard Deviation|Mean
2672078|NCT01472822|Secondary|Changes in Lysholm Index Score|"Lysholm index score total score (score 0-100) was measured in study visit 1(0 week) and visit 3(12 week).~The original index consists of 9 Questions(Limp, Assive devices, Up stair, Giving way, Sauat, Sit down&up, Cripitation, Swelling, Pain). Lysholm index score total score summed to form a score ranging from 0 (worst) to 100 (best)."|12 weeks|per protocol analysis|||units on a scale(0-100)||Standard Deviation|Mean
2672079|NCT01472822|Primary|Changes in WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Totol Score|"WOMAC(Western Ontario and McMaster University Osteoarthritis Index) total score (score 0-96) was measured in study visit 1(0 week) and visit 3(12 week).~The original index consists of 24 Questions. Individual question response is assigned a score of between 0 (none) to 4 (extreme) and summed to form a score ranging from 0 (best) to 96 (worst)."|12 weeks|per protocol analysis|||Score||Standard Deviation|Mean
2672080|NCT01472757|Secondary|Assessment of Acceptability of the Device|Percentage of subjects that overall found it very easy, fairly easy or fairy difficult to use the inhaler, based on inhaler acceptability questionnaire.|12 weeks|Number of participants analyzed aligns with Full Analysis Set|||Participants|||Count of Participants
2672081|NCT01472757|Secondary|Mean Change From Start of Treatment Baseline to End of Study (Week 12) for In-clinic Weekly Morning Pre-dose Peak Expiratory Flow (PEF)||Baseline and 12 weeks|Full Analysis Set analyzed, but number of patients analyzed represents subjects with both start of treatment baseline value and end of treatment value where a Last Observation Carried Forward (LOCF) approach was used to impute values of missing post-baseline visits; 1 subject had no post-dose PEF assessment, baseline values were not carried forward|||L/min||Standard Deviation|Mean
2672082|NCT01472757|Secondary|Number of Participants With Withdrawals Due to Worsening of Asthma||12 weeks|Number of participants analyzed aligns with Full Analysis Set.|||Participants|||Count of Participants
2672083|NCT01472757|Primary|Mean Change From Start of Treatment Baseline to End of Study (Week 12) for In-clinic Morning Pre-Dose Forced Expiratory Volume In 1 Second (FEV1)||Baseline and 12 weeks|Full analysis set analyzed, but number of patients represents subjects with both start of treatment baseline value and end of treatment value where a Last Observation Carried Forward (LOCF) approach was used to impute values of missing post-baseline visits; 2 subjects had no post-dose FEV1 assessments, baseline values were not carried forward|||Liters||Standard Deviation|Mean
2672084|NCT01472718|Primary|Infarct Size as Assessed by Delayed-enhancement Cardiac Magnetic Resonance Imaging (DE-MRI)||3 months after the index procedure||||% of LV mass||Standard Deviation|Mean
2672085|NCT01472718|Primary|Rate of Complete ST-segment Elevation Resolution at 60 Minutes After the End of the Procedure||60 minutes after the end of the procedure||||Participants|||Count of Participants
2672086|NCT01472692|Primary|Changes in Pulse Wave Velocity||8 weeks|The Principal Investigator for this study has passed away and the results data is not available.||||||
2672087|NCT01472692|Primary|Changes in 24 Hour Blood Pressure||8 weeks|The Principal Investigator for this study has passed away and the results data is not available.||||||
2672088|NCT01472562|Secondary|Safety as Measured by Number of Subjects Who Experience an Adverse Event While on Study Treatment||10 years|||||||
2672089|NCT01472562|Secondary|Time to Next Treatment|Median amount of time (in months) from start of study treatment to next treatment|10 years|||||||
2672090|NCT01472562|Secondary|Overall Survival|Overall survival will be defined as the time from first treatment day until death.|10 years|||||||
2672091|NCT01472562|Secondary|Progression-free Survival|PFS will be defined as the time from first treatment day until objective or symptomatic progression or death.|10 years|||||||
2672092|NCT01472562|Primary|Overall Response Rate|The primary endpoint of overall response rate will be estimated and a 95% confidence interval will be estimated via binomial proportions.|30 months||||percentage of patients||95% Confidence Interval|Number
2672093|NCT01472549|Secondary|Cost Savings||30 days|Cost data was not collected because it as not logistically feasible.||||||
2672100|NCT01472549|Primary|Number of Participants With Surgical Site Infection|Superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of the National Healthcare Safety Network definitions of the Centers for Disease Control and Prevention.|30 days||||Participants|||Count of Participants
2672101|NCT01472445|Other Pre-specified|Pharmacokinetics of Vitamin D Metabolite Calcitriol|Blood levels (pharmacokinetics) of Vitamin D were evaluated as the blood levels of Vitamin D metabolite calcitriol (also known as 1,25-dihydroxycholecalciferol or 1,25(OH)2D) in participants receiving 400 IU/day Vitamin D. The outcome is reported as the mean calcitriol level pre-treatment and post-treatment, with standard deviation.|up to 6 weeks|All participants are included. Pharmacokinetics results are provided for non-obese vs obese participants, stratified by dose received, and presented as the pre-treatment and post-treatment pharmacokinetic values.|||ng/mL|Samples for this dose & time|Standard Deviation|Mean
2672102|NCT01472445|Other Pre-specified|cRP (C-reactive Protein) to Adiponectin Ratio (cRP:Adiponectin) in Blood|Levels in blood of cRP (C-reactive protein) & adiponectin were assessed at baseline & after treatment in participants with body mass index (BMI) ≤25 and >25. By protocol design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day & 10,000 IU/day. For all serum protein levels, the outcome is the ratio of the baseline to post-treatment values (baseline:post-treatment) of the ratio of the mean serum levels of leptin & adiponectin, (ie, lepton:adiponectin). As a ratio of the ratio of means, the outcome is reported as a number without dispersion. The outcome value expresses the treatment effect on cRP and adiponectin collectively, with a value < 1.00 meaning effect on cRP levels was reduced relative to the effect on adiponectin levels, and a value > 1.00 meaning effect on cRP levels was increased relative to the effect on adiponectin levels, with a larger difference from 1.00 indicating a greater effect (1.00 represents no measure change).|up to 6 weeks|Study cohorts (non-obese vs obese) are stratified by Vitamin D dose level.|||ratio baseline:post-treatment (slope)|||Number
2672103|NCT01472445|Other Pre-specified|HOMA-IR to Adiponectin Ratio (HOMA-IR:Adiponectin) in Blood|The Homeostasis Model of Assessment-Insulin Resistance (HOMA-IR) was used to assess fasting insulin & glucose levels. HOMA-IR & adiponectin were assessed at baseline & after treatment in participants with body mass index ≤25 and >25. By protocol design, the outcome is for non-obese vs obese participants stratified between 400 & 10,000 IU/day. For all serum protein levels, the outcome is reported as the ratio of the baseline to post-treatment values (baseline:post-treatment) of the ratio of the mean serum levels of leptin & adiponectin, (ie, lepton:adiponectin). As a ratio of the ratio of means, the outcome is reported as a number without dispersion. The outcome expresses the treatment effect on HOMA-IR & adiponectin collectively, with <1.00 meaning effect on HOMA-IR levels is reduced relative to the effect on adiponectin levels, & >1.00 meaning the effect is increased relative, with a greater difference meaning greater effect (1.00 represents no measure change).|up to 6 weeks|Study cohorts (non-obese vs obese) are stratified by Vitamin D dose level.|||ratio baseline:post-treatment (slope)|||Number
2672104|NCT01472445|Other Pre-specified|Leptin to Adiponectin Ratio (Leptin:Adiponectin) in Blood|Levels in blood of leptin & adiponectin were assessed at baseline & after treatment in participants with body mass index ≤25 and >25. By protocol design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day and 10,000 IU/day. For all serum protein levels, the outcome is reported as the ratio of the baseline to post-treatment values (baseline:post-treatment) of the ratio of the mean serum levels of leptin and adiponectin, (ie, lepton:adiponectin). As a ratio of the ratio of means, the outcome is reported as a number without dispersion. The outcome value expresses the treatment effect on both leptin and adiponectin collectively, with a value <1.00 meaning that the effect on leptin levels was reduced relative to the effect on adiponectin levels, and a value >1.00 that the effect on leptin levels was increased relative to the effect on adiponectin levels, with a larger difference from 1.00 indicating a greater effect (1.00 means no measure change).|up to 6 weeks|Study cohorts (non-obese vs obese) are stratified by Vitamin D dose level.|||ratio baseline:post-treatment (slope)|||Number
2672105|NCT01472445|Other Pre-specified|Expression Level of ESR1 Gene|ESR1 gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect.|up to 6 weeks|Study cohorts (non-obese vs obese) are stratified by Vitamin D dose level.|||ratio baseline:post-treatment (slope)||Standard Deviation|Mean
2672106|NCT01472445|Other Pre-specified|Expression Level of MKI67 Gene|Ki 67 gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect.|up to 6 weeks|Study cohorts (non-obese vs obese) are stratified by Vitamin D dose level.|||ratio baseline:post-treatment (slope)||Standard Deviation|Mean
2672107|NCT01472445|Secondary|Expression Level of Matrix Metalloproteinase-11 (MMP-11) Gene|Matrix metalloproteinase-11 (MMP-11), aka Stromelysin-3 (SL-3), gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect.|up to 6 weeks|Study cohorts (non-obese vs obese) are stratified by Vitamin D dose level.|||ratio baseline:post-treatment (slope)||Standard Deviation|Mean
2672346|NCT01469182|Secondary|Number of Participants Reporting Ear Pruritus|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with ear pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment|||Participants|||Number
2672108|NCT01472445|Secondary|Expression Level of Cyclin-dependent Kinase Inhibitor 1 (CDKI1; p21) Gene|p21 [aka p21Cip1; p21Waf1, cyclin-dependent kinase inhibitor 1 (CDKI1) or cyclin-dependent kinase (CDK)-interacting protein 1 (CDKIP1)] gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect.|up to 6 weeks|Study cohorts (non-obese vs obese) are stratified by Vitamin D dose level.|||ratio baseline:post-treatment (slope)||Standard Deviation|Mean
2672109|NCT01472445|Primary|Expression Level of Insulin-like Growth Factor-binding Protein 3 (IGFBP-3) Gene|"To determine whether dietary vitamin D can reverse the negative effects of obesity and insulin resistance as reflected by changes in breast cancer gene expression patterns in obese and non-obese subjects diagnosed with breast cancer. IGFBP-3 is an endocrine factors.~Insulin-like growth factor-binding protein 3 (IGFBP-3) gene expression was assessed at baseline and after treatment in participants with body mass index (BMI) ≤ 25 and > 25. By design, the outcome was determined for non-obese vs obese participants stratified between 400 IU/day (control) and 10,000 IU/day (experimental), and is reported as the mean of the slope (a measure of magnitude of difference) between baseline and post-treatment, with standard deviation. A positive slope indicates increased expression, and a negative slope indicates decreasing values, with the larger values (positive or negative) indicating greater effect, and smaller values indicating lesser effect."|up to 6 weeks|Study cohorts (non-obese vs obese) are stratified by Vitamin D dose level.|||ratio baseline:post-treatment (slope)||Standard Deviation|Mean
2672110|NCT01472432|Secondary|iNOS|The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate iNOS concentration. Higher values represent more factor.|3 months|The analysis was not performed because an inadequate amount of biopsy tissue||||||
2672111|NCT01472432|Secondary|VEGF-R1 (Total and Phosphorylated Form), VEGF-R2 (Total and Phosphorylated Form)|The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate VEGF-R1 concentration. Higher values represent more factor.|3 months|The analysis was not performed because an inadequate amount of biopsy tissue||||||
2672112|NCT01472432|Secondary|VEGF|The factor is assessed by immunoblot analysis (commercial kits).Arbitrary unit of measure are used to evaluate VEGF concentration. Higher values represent more factor.|3 months||||arbitrary units||Inter-Quartile Range|Median
2672113|NCT01472432|Secondary|HIF-1α|The factor is assessed by immunoblot analysis (commercial kits). Arbitrary unit of measure are used to evaluate HIF-1α concentration. Higher values represent more factor.|3 months||||arbitrary units||Inter-Quartile Range|Median
2672114|NCT01472432|Primary|Capillary Density|"Biopsy is performed from the periphery of the ulcer, before and after treatment with vildagliptin, in order to evaluate the above referred outcome.~Capillary density is measured using immunohistochemistry"|3 months of treatment with vildagliptin||||capillaries/mm2||Inter-Quartile Range|Median
2672115|NCT01472432|Primary|Full Epithelialization of the Wound|"Biopsy is performed from the periphery of the ulcer, before and after treatment with vildagliptin, in order to evaluate the above referred outcome.~Optic microscopy is used to evaluate the epithelialization of the wound."|3 months of treatment with vildagliptin||||participants|||Number
2672116|NCT01472380|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-infinity]|The area under the plasma concentration versus time curve from time 0 to infinity. [AUC(0 to infinity)] was calculated as the sum of AUC (0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant for efavirenz.|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96, and 120 hours after dose administration|28 of 30 subjects completed the entire study and had sufficient data to calculate at minimum the area under the plasma concentration versus time curve from time 0 to infinity for efavirenz.|||h*ug/mL||Standard Deviation|Mean
2672117|NCT01472380|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time 0 to Time t[AUC(0-t)]|The area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule for efavirenz|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96, and 120 hours after dose administration|28 of 30 subjects completed the entire study and had sufficient data to calculate at minimum the area under the plasma concentration versus time curve from time 0 to the time t of the last quantifiable concentration (AUC0-t) for efavirenz.|||h*ug/mL||Standard Deviation|Mean
2672118|NCT01472380|Primary|Pharmacokinetics: Maximum Plasma Concentration (Cmax)|The maximum or peak concentration that the drug reaches in the plasma for efavirenz|serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 31 and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 48, 72, 96, and 120 hours after dose administration|28 of 30 subjects completed the entire study and had sufficient data to calculate at minimum the maximum concentration (Cmax)for efavirenz.|||ug/mL||Standard Deviation|Mean
2672119|NCT01472341|Primary|Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) According to Quartiles of Proinsulin/Insulin (PI/I) Ratio|HOMA is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. HOMA%B was defined as 20 x fasting insulin (mU/L)/fasting glucose (mmol/L) - 3.5. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion.|Baseline|Participants with fasting plasma insulin and glucose concentration assessments at baseline.|||Percentage Beta Cell Function||Standard Deviation|Mean
2672120|NCT01472341|Primary|Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at 4 Years|Proinsulin is the prohormone precursor to insulin made in the beta cells of the islets of Langerhans, specialized regions of the pancreas. A raised proinsulin-to-insulin ratio due to impaired processing of proinsulin is an early marker of beta cell dysfunction. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion.|Baseline and Year 4|Participants who had laboratory parameters at Baseline and at Year 4.|||PI/I||Standard Deviation|Mean
2672121|NCT01472341|Primary|Change From Baseline in Homeostatic Model Assessment Fasting Beta Cell Function (HOMA % B) at 4 Years|HOMA is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. HOMA%B was defined as 20 x fasting insulin (mU/L)/fasting glucose (mmol/L) - 3.5.|Baseline and 4 years|Participants who had laboratory parameters at Baseline and at Year 4.|||Percentage of Beta Cell Function||Standard Deviation|Mean
2672122|NCT01472289|Secondary|Number of Participants Able to Walk From Baseline to 12 Months as Measured by 6-Minute Walk Test|Subjects were analyzed to see if they were able to walk any distance and the distance covered by patients in 6 minutes was measured to assess the functional changes from baseline. The American Thoracic Society has issued guidelines for the 6-minute walk test (6 MWT). The 6 MWT is safe, easy to administer, well tolerated, and reflects activities of daily living.|Baseline, 1, 3, 6 and 12 months|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).|||Participants|||Number
2672123|NCT01472289|Secondary|Clinical Evaluation for the Presence of Ulcer and/or Gangrene in the Affected Limb From Baseline to 12 Months|Evaluation of the integument for ulceration, gangrene and other skin changes in the affected limb was performed at baseline and follow-up visits at 1 month, 3 months, 6 months, and 12 months.The ulceration and gangrene in the affected limb of the subjects was evaluated by visual clinical inspection.|Baseline, 1, 3, 6 and 12 months|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).|||Participants|||Number
2672124|NCT01472289|Secondary|Change in Rest Pain and Intermittent Claudication Assessment From Baseline to 12 Months|"Rest pain is a burning sensation felt at rest, usually in the skin of the foot. It is a symptom of critical ischemia due to severe, chronic, and occlusive peripheral arterial disease (PAD). While, Intermittent Claudication is a crampy leg pain that occurs during exercise, especially walking. The pain is due to the insufficient blood flow in the legs (caused by blocked arteries). Intermittent claudication is the most prominent symptom of PAD.~Both Rest Pain assessment and Intermittent Claudication assessment was performed through Visual Analog Scale or Visual Analogue Scale (VAS). VAS is a psychometric (self-report) response scale that ranges from 0 to 10, where a mark of zero indicates no pain and a mark of 10 indicates worst possible pain."|Baseline, 1, 3, 6 and 12 months|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).|||scores on a scale||Standard Deviation|Mean
2672125|NCT01472289|Secondary|Measurement of Change in Transcutaneous Oxygen Pressure (TcPO2) From Baseline to 12 Months|TcPO2 was used to assess the partial pressure (tension) of oxygen in the capillaries of tissues of lower limbs. It was measured by applying a special set of electrodes to the skin. These electrodes contain photoelectric sensors capable of detecting the specific wavelengths of radiation emitted by oxygenated versus reduced hemoglobin.|Baseline, 1, 3, 6 and 12 months|The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).|||mmHg||Standard Deviation|Mean
2672126|NCT01472289|Secondary|Measurement of Mean Change in Ankle Brachial Index From Baseline to 12 Months|ABI was used to provide a measure of blood flow in the lower limbs. It is the ratio of the blood pressure in the lower limbs to the blood pressure in the upper limbs. Compared to the upper limb, lower blood pressure in the lower limb is an indication of blocked arteries (peripheral vascular disease). The ABI was calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm. ABI test was performed at baseline, 1 month, 3 months, 6 months, and 12 months.|Baseline, 1, 3, 6 and 12 months|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).|||Ratio||Standard Deviation|Mean
2672127|NCT01472289|Secondary|Degree of Angiogenesis Measured by the Number of Collateral Blood Vessels Formed at 12 Months|Measurement of blood supply facilitated by the formation of collateral blood vessels assessed by CT angiography after the procedure.|Baseline and 12 month|Efficacy measures were established by assessing CLI symptoms known to be reliable and valid. The efficacy endpoints were analyzed on per protocol (PP) basis (N=14).|||Number of Vessels||Standard Deviation|Mean
2672128|NCT01472289|Primary|Number of Participants With Adverse Events as a Measure of Safety and Major Limb Amputation Free Survival Post BMMNC Administration|The Primary objective of this study was to determine the safety of intramuscular administration of concentrated autologous BMMNCs harvested, and processed using the Res-Q 60 technology (a point-of-care system). Safety measurements included close vigilance for major limb amputation free survival at 1, 3, 6 and 12 months post BMMNCs administration and stringent reporting of AEs and SAEs.|1, 3, 6 and 12 Months|All the safety end points in the study were analyzed on the ITT population. Out of 17 subjects, adverse events were reported for seven subjects. Of the seven subjects, three underwent major amputation, two reported minor amputation, and two died due to cardiac arrest (unrelated death). Furthermore, major limb amputation free survival rate was 14.|||participants|||Number
2672129|NCT01472185|Secondary|Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24|The average (mean) change from baseline in incremental change of 2-hour postprandial serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the Mixed Meal Tolerance Test (MMTT) Full Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
2672490|NCT01468974|Secondary|In-scaffold Peak Systolic Velocity Ratio (PSVR)|Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound|6 months|PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.|||ratio||Standard Deviation|Mean
2672130|NCT01472185|Secondary|Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24|"The average (mean) change from baseline in 2-hour postprandial serum glucose at Week 24 was analyzed.~Mixed Meal Tolerance Test (MMTT) Full Analysis Set: randomized participants who received at least one dose of study treatment with a baseline and at least one postbaseline measurement of serum glucose at time [T] = 120 minutes during the MMTT, administered under fasting conditions, excluding participants with major eligibility protocol violations and analyzed based on the randomized treatment regardless of actual treatment received."|Baseline; Week 24|Participants in the Mixed Meal Tolerance Test (MMTT) Full Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
2672131|NCT01472185|Secondary|Percentage of Participants With HbA1c < 7% at Week 24||Week 24|Participants in the Full Analysis Set with Baseline HbA1c ≥ 7% and available data were analyzed.|||percentage of participants|||Number
2672132|NCT01472185|Secondary|Change From Baseline in Fasting Serum Glucose at Week 24|The average (mean) change from baseline in fasting serum glucose at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set with available data were analyzed.|||mg/dL||Standard Deviation|Mean
2672133|NCT01472185|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|The average (mean) change from baseline in HbA1c at Week 24 was analyzed.|Baseline; Week 24|Participants in the Full Analysis Set (randomized participants who received ≥ 1 dose of study treatment with a baseline and at least one postbaseline measurement of HbA1c, excluding subjects with major eligibility violations and analyzed based on the randomized treatment regardless of actual treatment received) with available data were analyzed.|||percent of HbA1c in blood||Standard Deviation|Mean
2672134|NCT01472081|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the date of first dose of study medication to the date of first disease progression or death. Participants who did not have any on-study tumor assessment and did not die were censored on the date of first dose of study medication.|From date of first dose to date of disease progression or death, whichever occurred first (assessed up to March 2016, approximately 49 months)|All treated participants|||months||95% Confidence Interval|Median
2672135|NCT01472081|Secondary|Rate of Progression-free Survival (PFS) at Week 24|Rate of PFS at week 24 was defined as the proportion of participants remaining progression free or surviving at 24 weeks, calculated by the product-limit method (Kaplan-Meier estimate) which took into account censored data. Participants who did not have any on-study tumor assessment and did not die were censored on the date of first dose of study medication.|24 weeks|All treated participants|||Percentage of participants with PFS||95% Confidence Interval|Number
2672136|NCT01472081|Secondary|Duration of Response (DOR)|DOR was computed for participants with BOR of CR or PR only, and defined as the time between the date of first documented objective response and the date of the first subsequent disease progression or death. Participants who remained alive and had not progressed were censored on the last tumor assessment date (prior to subsequent cancer therapy).|From date of first dose to date of disease progression or death, whichever occurred first (assessed up to March 2016, approximately 49 months)|All treated participants|||weeks||95% Confidence Interval|Median
2672137|NCT01472081|Secondary|Objective Response Rate (ORR)|"ORR was defined as the proportion of participants who achieved a BOR of either complete response (CR) or partial response (PR) in the population of interest.~CR = Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."|From date of first dose to interim analysis (Assessed up to March 2016, approximately 49 months)|All treated participants|||percentage of participants||95% Confidence Interval|Number
2672138|NCT01472081|Secondary|Best Overall Response Rate (BOR)|"BOR was defined as the best response designation over the study as a whole, recorded between the date of first dose of study medication and the date of objectively documented progression per RECIST 1.1 criteria or the date of subsequent anti-cancer therapy, whichever occurred first.~CR = Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR = At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD = At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. SD = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|From date of first dose to date of disease progression or subsequent anti-cancer therapy, whichever occurred first (assessed up to March 2016, approximately 49 months)|All treated participants|||percentage of participants|||Number
2672139|NCT01472081|Primary|Number of Participants With AEs, SAEs, and AEs Leading to Discontinuation|Safety assessments by treatment arm and dose level were based on incidence of AEs, and the incidence of serious adverse events (SAEs). AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling.|From date of first dose to date of last dose plus 100 days (assessed up to March 2016, approximately 49 months)|All treated participants|||participants|||Number
2672140|NCT01471782|Secondary|Serum Cytokine Peak Levels|The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-10, tumor necrosis factor-alpha (TNF-α) and interferon gamma (IFN-ɣ) using cytometric bead assays. The limit of detection of the assay (LOD) was 20 pg/mL and the lower limit of quantification (LLOQ) was 125 pg/mL. Data below LOD were set to 10 pg/mL while data < LOQ and > LOD were reported as measured.|Cycle 1 and 2 day 1 (prior to infusion, 2 and 6 hours after infusion start), day 2 and day 3.|Phase 1 full analysis set participants with available data|||pg/mL||Standard Deviation|Mean
2672141|NCT01471782|Secondary|Number of Participants Who Developed Anti-blinatumomab Antibodies|Antibodies to blinatumomab were detected using an electrochemiluminescence (ECL)-based assay.|Predose up until 30 days after last dose of study medication; median treatment duration was 28 days.|Full analysis set|||participants|||Number
2672142|NCT01471782|Secondary|Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant During Blinatumomab Induced Remission|The percentage of participants who received allogeneic hematopoietic stem cell transplantation (HSCT) while in remission due to treatment with blinatumomab during the first two cycles, and received no further anti-leukemic medication before HSCT.|Up to the data cut-off date of 12 January 2015; Maximum duration on study was 24 months in phase 1 and 15 months for phase 2.|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2672143|NCT01471782|Secondary|Relapse-free Survival|"Relapse-free survival (RFS) was assessed for participants who achieved a complete remission during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to any cause. Participants without a documented relapse (hematological or extramedullary) or who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission.~Relapse free survival was estimated using Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan-Meier method."|Up to the data cut-off date of 12 January 2015; median observation time was 23.5 months for phase 1 and 11.5 months for phase 2.|Full analysis set with complete remission|||months||95% Confidence Interval|Median
2672144|NCT01471782|Secondary|Overall Survival|"Overall survival (OS) was measured for all participants from the first treatment of blinatumomab until death due to any cause or the date of the last follow-up. Participants who did not die were censored on the last documented visit date or the date of the last contact when the patient was last known to have been alive. For patients who withdrew their informed consent only information until the date of withdrawal was analyzed.~Overall survival was estimated using Kaplan-Meier methods. The median follow-up time with respect to overall survival was calculated by the reverse Kaplan-Meier method."|Up to the data cut-off date of 12 January 2015; median observation time was 23.5 months for phase 1 and 11.6 months for phase 2.|Full analysis set|||months||95% Confidence Interval|Median
2672145|NCT01471782|Secondary|Time to Hematological Relapse (Duration of Response)|"Time to hematological relapse was measured only for participants in remission and was measured from the time the participant first achieved remission until first documented relapse or death due to disease progression. Participants without a documented relapse (hematological or extramedullary) and who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death.~Hematological relapse is defined as the proportion of blasts in bone marrow > 25% following documented remission, or extramedullary relapse.~Time to hematological relapse was analyzed by Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method."|Up to the data cut-off date of 12 January 2015; median observation time was 23.5 months for phase 1 and 11.5 months for phase 2.|Full analysis set with complete remission|||months||95% Confidence Interval|Median
2672146|NCT01471782|Secondary|Steady State Concentration of Blinatumomab|"Blinatumomab serum concentrations were quantified in all patients during the first 2 treatment cycles in the phase 1 part of the study only. Blinatumomab concentrations were quantified using a validated bioassay, the lower limit of quantification was 50 pg/mL. Steady state serum concentration (Css) was presumed on day 1, approximately 5 half-lives after the start of the IV infusion.~The steady state serum concentration reported is the mean of the observed concentrations collected after during cycles 1 and 2."|Cycles 1 and 2 during the IV infusion on day 3 (at least 48 hours after start of infusion) and days 8, 15 and 22 (steady state) and day 29 at End of Infusion (EoI) and 2, 4, and 8 hours after EoI for ages ≥ 2 years.|Phase 1 participants with available blinatumomab concentration data|||pg/mL||Standard Deviation|Mean
2672147|NCT01471782|Secondary|Number of Participants With Adverse Events|"The severity (or intensity) of adverse events (AEs) was assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), v4.03 and according to the following:~Grade 1 - Mild adverse event; Grade 2 - Moderate adverse event; Grade 3 - Severe and undesirable adverse event; Grade 4 - Life-threatening or disabling adverse event; Grade 5 - Death. The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab."|From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle, median treatment duration was 28 days|Full analysis set|||participants|||Number
2672148|NCT01471782|Primary|Percentage of Participants With Complete Remission in the First Two Cycles|"Hematological assessments were performed from bone marrow biopsy samples. All hematological assessments of bone marrow were reviewed in a central laboratory. Complete remission (CR) was defined as~M1 bone marrow (bone marrow blasts < 5%)~No evidence of circulating blasts or extra-medullary disease~Complete remission includes participants with incomplete recovery of peripheral blood counts."|Cycles 1 and 2 (12 weeks)|The full analysis set includes all participants who received any infusion of blinatumomab.|||percentage of participants||95% Confidence Interval|Number
2672149|NCT01471782|Primary|Phase I: Number of Participants With Dose-limiting Toxicities (DLTs)|"The maximum tolerated dose (MTD) was defined as one or fewer out of 6 participants experiencing a dose limiting toxicity (DLT) or the maximum administered dose (MAD).~A dose limiting toxicity is any Grade ≥ 3 adverse event related to study drug, Grade 3 fatigue, headache, insomnia, fever, hypotension or infection were not considered dose limiting toxicities. Laboratory parameters of Grade ≥ 3 but not considered as clinically relevant and/or responding to routine medical management, thrombocytopenia, leukopenia (including neutropenia and lymphopenia), and anemia were not considered dose limiting toxicities."|Cycle 1, 28 days|Participants in the Phase 1 dose evaluation/escalation part of the study|||participants|||Number
2672150|NCT01471691|Secondary|Total Number of Ranibizumab Injections||month 12|||||||
2672151|NCT01471691|Secondary|Excess Foveal Thickness||Month 6 and 12|||||||
2672152|NCT01471691|Secondary|Percentage of Patients With CFT Less Than 300um||Month 6 and 12|||||||
2672153|NCT01471691|Secondary|Change in Mean Best Corrected Visual Acuity From Baseline||months 1-12|||||||
2672154|NCT01471691|Secondary|Mean Change From Baseline in Center Point Thickness||months 1-12|||||||
2672155|NCT01471691|Primary|Mean Change From Baseline BCVA|Vision was measured using a standard ETDRS chart at baseline and each subsequent monthly visit.|Baseline to month 6||||Letters (ETDRS chart)||Standard Deviation|Mean
2672156|NCT01471379|Secondary|Dose Related Incremental Benefit in Pain Reduction Based on VAS|The investigator was looking to see if, for group A, when increased from 50 mg BID to 100 mg BID there is significant improvement of pain scores i.e. 30% pain reduction, and for group C, if there was significant improvement of pain scores when switched from placebo to 50 mg BID of Milnacipran|12 Weeks||||percentage of participants|||Number
2672157|NCT01471379|Secondary|Treatment Efficacy Questionnaire (TEQ)|Treatment Efficacy Questionnaire is a measure of treatment effectiveness. The score ranges from 1 to 48, 1 is minimum score and 48 is the maximum score. The investigators was looking to see if the Milnacipran treatment groups have a higher proportion of subjects with significant improvement in efficacy, judged as a TEQ score of >28, compared to placebo group.|Twelve Weeks|Only one subject was enrolled and was analyzed even though subject did not complete the study.|||percentage of subject with score >28|||Number
2672158|NCT01471379|Secondary|Subject Self Reported Adequate Relief of Pain|The study sought to determine if the Milnacipran arms had a greater proportion of adequate relief over the placebo group. Subjects were asked to answer 'yes' or 'no' as to whether or not they had adequate relief of pain due to irritable bowel syndrome.|Twelve Weeks||||percentage of participants|||Number
2672159|NCT01471379|Secondary|Quality of Life ( IBS-QOL)|After six weeks of treatment with Milnacipran, treatment groups were compared with placebo for clinically significant improvement in IBS-QOL. 11 point reduction in IBS-QOL compared to baseline was considered as clinically significant improvement.|Six Weeks|||||||
2672160|NCT01471379|Primary|Number of Participants With Pain Response|Visual Analog Scale (VAS) scores (range 0-100 mm; 0 = none, 100 = worst pain) were recorded for pain before the beginning of the study, at 6 weeks of treatment and at the end visit i.e. 10 weeks. Ideally, VAS would have been administered at the 12th week; however, subject was terminated at the 10th week visit. A positive pain response (ie pain relief) was defined as >30% decrease in the VAS score between baseline and the final study visit.|Twelve Weeks||||participants|||Number
2672161|NCT01471353|Secondary|Correlative Tissue Analysis|Exploratory tissue analysis in patients receiving sorafenib plus capecitabine|6 months|Data were not collected.||||||
2672162|NCT01471353|Secondary|Toxicity (Percentage of Subjects That Experienced an Adverse Event)|Evaluate acute toxicity of treatment. The toxicity assessments were graded by the NCI CTCAE (Clinical Trial Common Adverse Event) grading system - a global standard for assessments of clinical and laboratory toxicities. All toxicities are scored 1(mild) through 5 (death related to the event) based upon well-defined and reproducible definitions.|12 months||||percentage of participants|||Number
2672163|NCT01471353|Secondary|Response Duration|This is the median response duration (median time from date of a complete or partial response to date of disease progression per RECIST 1.1 criteria) and includes only subjects that achieved either a complete or partial response to treatment per RECIST 1.1 criteria.|up to 12 months|No data are available for this outcome measure since only 1 participant achieved a partial or complete response.||||||
2672164|NCT01471353|Secondary|Response Rate|This is the percentage of subjects that achieved either a complete response or a partial response per RECIST 1.1 criteria|3 months||||percentage of participants||95% Confidence Interval|Number
2672165|NCT01471353|Secondary|Overall Survival|Evaluate overall survival after treatment.|5 years||||days||95% Confidence Interval|Median
2672166|NCT01471353|Primary|Sorafenib Activity|Determine activity of sorafenib plus capecitabine on progression free survival (PFS) in patients with advanced colorectal cancer. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|2 years||||days||95% Confidence Interval|Median
2672167|NCT01471340|Other Pre-specified|Number of SAO Components in MF/F Participants vs MF Participants|To further examine the primary safety outcome, each adjudicated component of the SAO composite endpoint (asthma-related hospitalization, asthma-related intubation and asthma-related death), was tabulated for descriptive purposes only to show the relative contribution of each component to the SAO composite. Hospitalizations were defined as an in-patient stay of >= 24 hour in a hospital, emergency department or equivalent healthcare facility. Intubation was defined as endotracheal intubation only.|26 weeks, or 7 days after the last treatment dose, whichever occurred later|The analyzed population for tabulation of the number of SAO components was all participants who received at least one dose of randomized treatment assignment (intention-to-treat principle).|||SAO components|||Number
2672168|NCT01471340|Secondary|Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms|The key secondary efficacy outcome was time-to-first protocol-defined asthma exacerbation (SAEX). The SAEX were deteriorations of asthma requiring: use of systemic corticosteroids (tablets, suspension, or injection) for >= 3 consecutive days, in-patient hospitalization >= 24 hours, or an emergency department (ED) visit < 24 hours that required systemic corticosteroids in the MF/F MDI BID arm versus the MF MDI BID arm. The number of first SAEX occurred from initiation of study treatment to 7 days after the last treatment (modified intention-to-treat). This outcome was measured as the HR and 95% CI for the number of first SAEX in the MF/F MDI BID arm versus the number of first SAEX in the MF MDI BID arm. Given insufficient data for SAEX events, it was not informative to report the time-to-first SAEX in the overall population. Therefore, the number of first SAEXs in either arm is reported as a descriptive measure. For each participant, first SAEX denotes first event per participant.|26 weeks, plus 7 days after the last treatment|The analyzed population for assessment of the number of first asthma exacerbations was all treated participants who received at least one dose of randomized treatment assignment (intention-to-treat principle).|||Asthma exacerbations|||Number
2672180|NCT01471457|Primary|Number of Patients With Bacterial Vaginosis at 3 Months|The primary outcome is the rate of bacterial vaginosis after pessary fitting as measured by OSOM BV blue (Genzyme) and gram stain, measured in women using and women not using Trimo-San gel after pessary fitting, at 3 months, with the denominator being the number of women having a gram stain at the 3 months time point in each group|3 months||||Participants|||Count of Participants
2672253|NCT01470417|Primary|Pathologic Downstaging and Margin Status|Pathologic stage and margin status after resection. Pathologic downstaging was determined my looking at the rate of R0 (all residual tumor removed during surgery) vs R1 (microscopic tumor present at the resection margin per pathology) resections.|At the time of surgery after neoadjuvant therapy|Subjects who had a surgical resection of their primary tumor were included in this analysis.|||participants|||Number
2672169|NCT01471340|Primary|Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms|The primary safety outcome was the time-to-first SAO (a composite endpoint of adjudicated asthma-related hospitalizations, adjudicated asthma-related intubations, and adjudicated asthma-related deaths). To accomplish this, the number of participants experiencing a first SAO was collected for 26 weeks following initiation of study treatment (or 7 days after the last treatment dose, whichever occurred later). Data generated by this methodology were used to compute a hazard ratio (HR) and 95% confidence interval (CI), modeling the likelihood of a first SAO occurring at any given time in the MF/F arm relative to the MF arm. Although data were sufficient to generate a HR and 95% CI, time-to-first SAO in the overall population could not be accurately reported due to insufficient SAO occurrence. Therefore, the number of first SAO in either arm is reported as a descriptive measure. For each participant, first SAO denotes first event per participant.|26 weeks, or 7 days after the last treatment dose, whichever occurred later|The analyzed population for assessment of the number of first SAO was all participants who received at least one dose of randomized treatment assignment (intention-to-treat principle).|||Serious asthma outcomes|||Number
2672170|NCT01471639|Secondary|Adverse Event/Side Effects|Safety assessed by reporting of all adverse events and side effects.|Up to 4 hours|Participants who reported discomfort or unpleasant feeling associated with use of intranasal ketorolac|||Participants|||Count of Participants
2672171|NCT01471639|Primary|Efficacy of Intranasal Ketorolac on Numeric Pain Scale|Change in numeric rating scale after receiving intranasal ketorolac. 0 (no pain) - 10 (worst possible pain)|up to 4 hours|Improvement in pain score rating among participants rating from baseline pain scores, 20 minutes, 40 minutes, 1 hour, 2 hour, 3 hour and 4 hour post dose. Pain scale ranging from 0 (no pain) - 10 (worst possible pain)|||Participants|||Count of Participants
2672172|NCT01471626|Primary|Quality of Polysomnographic Recordings|Quality of recordings will be graded according to Redline S et al (SLEEP 1998): Unsatisfactory, poor, fair, good, very good,excellent. Unsatisfactory and poor recordings are considered as failures.|1 week||||percentage of recording failure|||Number
2672173|NCT01471574|Secondary|Number of Participants Who Died and With Serious Adverse Event (SAEs), Grade 3 to 4 Adverse Events (AEs), and AEs Leading to Discontinuation|Adverse event was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threating, an important medical event, or a congenital anomaly/birth defect; or required prolonged hospitalization. HAART=highly active antiretroviral therapy.|From Day 1 to 7 days post last dose of study treatment (up to Week 48)|The analysis was performed in all participants who received at least 1 dose of study drug.|||Participants|||Number
2672174|NCT01471574|Secondary|Percentage of Participants With Sustained Virologic Response (SVR12) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene|Percentages calculated as number of responders/number who received treatment.|Follow-up Week 12|The analysis was performed in all participants who received at least 1 dose of study therapy. Here 'n' signifies number of participants evaluable at the specified time-point.|||Percentage of participants||95% Confidence Interval|Number
2672175|NCT01471574|Secondary|Percentage of Participants Who Received Highly Active Antiretroviral Therapy (HAART), Maintained HIV RNA <40 Copies/mL, and Experienced Confirmed HIV RNA ≥400 Copies/mL|Participants who received HAART, maintained HIV RNA <40 copies/mL, and experienced confirmed HIV RNA ≥ 400 copies/mL were determined.|End of treatment (up to Week 48)|The analysis was performed in all participants who received at least 1 dose of study therapy|||Percentage of participants||95% Confidence Interval|Number
2672176|NCT01471574|Secondary|Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than the Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)|Participants who achieved HCV RNA levels lower than the LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.|Week 1, 2, 4, 6, 8, and 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24|The analysis was performed in all participants who received at least 1 dose of study therapy. On-treatment virologic response rates were not significantly different from one another among 30 mg, 60 mg, and 90 mg groups in the HAART cohort, thus these groups were combined as per pre-specified analysis plan.|||Percentage of participants|||Number
2672177|NCT01471574|Secondary|Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Lower Than The Lower Limit of Quantitation (LLOQ), Target Detected (TD) or Target Not Detected (TND)|Participants who achieved HCV RNA levels lower than the LLOQ i.e., 25 IU/ml, TD or TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.|Week 1, 2, 4, 6, 8, 12 and at both Weeks 4 and 12; end of treatment; and follow-up Weeks 12 and 24|The analysis was performed in all participants who received at least 1 dose of study therapy. On-treatment virologic response rates were not significantly different from one another among 30 mg, 60 mg, and 90 mg groups in the HAART cohort, thus these groups were combined as per pre-specified analysis plan.|||Percentage of participants|||Number
2672178|NCT01471574|Primary|Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)|SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy.|Follow-up Week 12|The analysis was performed in all participants who received at least 1 dose of study therapy.|||Percentage of participants||95% Confidence Interval|Number
2672179|NCT01471457|Secondary|Participants With Any Bothersome Vaginal Symptom at 3 Months|Vaginal symptoms and effect of vaginal symptoms on pessary wearers measured before and after pessary fitting by questionnaire based on verified vaginal symptoms questionnaire at 3 months, with the denominator being the number of women completing the questionnaire at the 3 months time point in each group|3 months||||Participants|||Count of Participants
2672181|NCT01471197|Secondary|Number of Participants With Deaths, Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Discontinuation - All Treated Participants|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. Participants were evaluated from Day 1 (first day of treatment with study drug) to the date of the last participant, last visit of the study.|Day 1 to Date of last patient, last visit, approximately 7 months after study started.|All participants who received at least one dose of study drug.|||participants|||Number
2672182|NCT01471197|Secondary|Number of Participants Who Died Within 30 Days and 31 Days After Last Dose - All Treated Participants|Due to study termination, the categories presented below are deaths occurring within 30 days of last dose and deaths occurring within 32 days of last dose. If the study had not been terminated early, the categories presented would have been 30 days and 90 days after last dose.|Day 1 of Treatment to Date of Death, up to last patient, last visit, approximately 7 months after study started.|All participants who were randomized and treated with at least one dose of either study drug.|||participants|||Number
2672183|NCT01471197|Primary|Overall Survival of Participants During the Study - All Treated Participants|Overall survival (OS) was defined as the time from the date of randomization until the date of death. For those participants who did not die by the time the study was terminated and last patient, last visit occurred, OS was censored (+) on the last date the participant was known to be alive. OS is presented below in increasing monthly categories of survival. OS analysis was to be performed when a total of approximately 132 deaths were observed but due to the early termination of the study, statistical analyses were not performed.|Date of Randomization to date of death, up to last patient, last visit, approximately 7 months after study started|All participants who received at least one dose of either study drug.|||participants|||Number
2672184|NCT01471171|Secondary|Change From Baseline in Intensity of Dyspnoea|Change from baseline in intensity of dyspnoea based on the Borg CR10 Scale® (ranging from '0'=nothing at all to '10'=extremely strong/maximal dyspnoea, the highest possible numerical value) at isotime during constant work rate cycle ergometry after 3 weeks of treatment.|Week 3|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population.|||Units on a scale||Standard Error|Least Squares Mean
2672185|NCT01471171|Secondary|Change From Baseline in Trough Inspiratory Capacity (IC) (Litres)|Change from baseline in trough IC after 3 weeks of treatment|Week 3|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population.|||Litres||Standard Error|Least Squares Mean
2672186|NCT01471171|Primary|Change From Baseline in Endurance Time (Seconds)|Change from baseline in endurance time during constant work rate cycle ergometry to symptom limitation at 75% of Maximum Work load (Wmax) after 3 weeks of treatment.|Week 3|Intention-to-Treat (ITT) population: all randomised patients who took at least one dose of investigational medicinal product, and had at least a baseline and one post-dose corresponding assessment value of the primary efficacy variable in one of the 2 treatment periods. 2 patients from the safety population were excluded from the ITT population.|||Seconds||Standard Error|Least Squares Mean
2672187|NCT01471054|Secondary|Development of Vitreous Hemorrhage|Development of hemorrhage in the vitreous cavity detectable with slit lamp examination or dilated funduscopy.|At 12 months||||Participants|||Count of Participants
2672188|NCT01471054|Secondary|Development of Retinal Detachment|Development of rhegmatogenous retinal detachment in the study eye.|At 12 months||||Participants|||Count of Participants
2672189|NCT01471054|Secondary|Development of Cataract|Development of visually-significant lens opacity based on judgement of examining physician.|At 12 months||||Participants|||Count of Participants
2672190|NCT01471054|Secondary|Development of Glaucoma|Intraocular pressure more than 21 mm Hg as measured with applanation tonometry.|At 12 months||||Participants|||Count of Participants
2672191|NCT01471054|Secondary|Change in Central Subfield Retinal Thickness|Increase or decrease in central subfield retinal thickness in microns based on spectral-domain optical coherence tomography measurement|At 12 months|We were not able to measure central macular thickness at 12 months in one patient in the Ozurdex group due to advanced cataract.|||micron||Standard Deviation|Median
2672192|NCT01471054|Primary|Number of Participants for Whom Study Eye Showed >=2 Lines of Improvement in Best-corrected Visual Acuity|The number of participants that developed 2 or more lines of visual acuity improvement in the study eye. Visual acuity was measured with Snellen eye chart placed 10 feet away from the patient.|At 12 months||||participants|||Number
2672193|NCT01471041|Secondary|Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide|Frequency of complications occuring when cannulating the arteriovenous fistula through the Venous Window Needle Guide|6 months||||participants|||Number
2672194|NCT01471041|Primary|Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis|Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure.|3 months||||participants|||Number
2672195|NCT01471028|Post-Hoc|Overall Survival for Subjects With Age<50, MELD<30, Bili>=16, INR<=2.5 and Creatinine<1.3|Creatinine <1.3 INR <=2.5 Bilirubin >=16 Age <50 MELD <30|Up to at least Study Day 91, with protocol VTI-208E providing additional survival data (at 6, 9, 12, 24 months) at the time of database lock (31 July 2015)|Kaplan-Meier|||Participants|||Count of Participants
2672248|NCT01470469|Primary|Change From Baseline in Height at up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||cm||Standard Deviation|Mean
2672196|NCT01471028|Other Pre-specified|Number of Progression-free Survivors at Study Day 91|An exploratory objective is to evaluate the ability of ELAD® to stabilize liver function, measured using the MELD-based time to progression (TTP), with progression defined as death or the first observed increase of at least 5 points from End of Study Day 1 MELD score (for both the ELAD and Control groups) until at least 24 hours after the ELAD Treatment Period is ended (end of Day 7 for Controls) and up to both End of Study Days 28 and 91 following Randomization.|Study Day 1 up to Study Day 91||||Participants|||Count of Participants
2672197|NCT01471028|Secondary|Number of Survivors at Study Day 91.|Assess the proportion of survivors at Study Day 91.|Up to Study Day 91.||||Participants|||Count of Participants
2672198|NCT01471028|Primary|Overall Survival|The primary endpoint of the study was a comparison of overall survival (OS) between the ELAD-treated and Control groups, with protocol VTI-208E providing additional survival data up to a maximum of 5 years, that was included as available at the time of database lock (31 July 2015).|Up to at least Study Day 91, with protocol VTI-208E providing additional survival data (at 6, 9, 12, 24 months) at the time of database lock (31 July 2015)||||Participants|||Count of Participants
2672199|NCT01471015|Primary|The Pharmacokinetic Profile of Darbe After the Second Dose.|"The pharmacokinetic profile of Darbe will be determined using population pharmacokinetic sampling in which babies will be randomized to have blood drawn at different intervals. A second dose of Darbe will be given at 7 days of age, and serum drug levels will be obtained at 12, 18, 24, and 36 hours post second dose. Area under the plasma concentration versus time curve (AUC) will be used."|For 36 hours after second dose||||AUC (h*mU/L)||Inter-Quartile Range|Median
2672200|NCT01471015|Primary|The Pharmacokinetic Profile of Darbe After the First Dose During Cooling|"The pharmacokinetic profile of Darbe wil be determined using population pharmacokinetic sampling in which babies will be randomized to have blood drawn at different intervals. Serum levels will be drawn at 4,12, 18, 24, 36, 60, and 72 hours post initial dose. Area under the plasma concentration versus time curve (AUC) will be used."|For 72 hours after first dose||||AUC (h*mU/L)||Inter-Quartile Range|Median
2672201|NCT01471015|Secondary|Number of Participants With Adverse Events.|"Potential adverse events such as (but not limited to) alterations in blood pressure, secondary infections, neutropenia, thrombotic/vascular events, hematologic events (platelets, Hct level, polycythemia), and hepatic/renal function that are outside of normal range for the study population.~Complications associated with HIE or cooling therapy will not be considered an AE for this study. AEs reported to be associated with cooling include: bleeding/thrombosis, persistent pulmonary hypertension of the newborn (PPHN), skin changes, arrhythmia, and persistent acidosis."|30 days or until hospital discharge||||participants|||Number
2672202|NCT01470859|Secondary|Patients With Clinical Improvement as Evaluated by Global Impression Scale (CGI).|"Patients with a score <= 2 (very much or much improved in relation to baseline) are considered as clinically improved.~The numbers of participants with clinical improvement are reported here. The completion of dosage titration within 10 weeks after baseline (visit 2) and 1 year after baseline (final visit)"|twice, at 10 weeks(V2) and 1 year(V5)||||participants|||Number
2672203|NCT01470859|Secondary|Hoehn&Yahr (H&Y) Staging|"The Hoehn and Yahr scale is a commonly used scale for describing how the symptoms of Parkinson's disease progress and the disease stages. Bigger numbers indicate more symptoms and disease progression. H&Y stage range from 0-5; the greater, the more severe.~The H&Y stages of patients were evaluated at baseline (1st visit, V1), and 1 year after baseline (final visit, V5)."|twice baseline and 1 year||||units on a scale||Standard Deviation|Mean
2672204|NCT01470859|Secondary|Parkinson's Disease Questionnaire (PDQ39)|"The PDQ39 score was assessed at baseline (1st visit, V1) and 1 year after baseline (final visit, V5).~PDQ39 score ranges from 0-156 (0-4 each item); the more score, the more severe."|twice baseline and 1 year||||units on a scale||Standard Deviation|Mean
2672205|NCT01470859|Secondary|Unified Parkinson's Disease Rating Score (UPDRS II, III)|baseline (1st visit, V1), completion of dosage titration within 10 weeks after baseline (2nd visit, V2), 1 year after baseline (final visit, V5) UPDRS II score 0-52 (13 items); UPDRS III score 0-56 (14 items); The more scores,the more severe; the two scales were evaluated separately.|three times: baseline, 10 weeks, 1 year||||units on a scale||Standard Deviation|Mean
2672206|NCT01470859|Primary|Longitudinal Change of Brain Network Activity|"The brain network activity is evaluated by Parkinson's disease-related spatial covariance pattern(PDRP) value (Z score).~The change of brain network activity is calculated by the PDRP value (Z score) at V5 - the PDRP value (Z score) at V1."|twice, baseline and 1 year after baseline||||Z-score in PDRP||Standard Deviation|Mean
2672207|NCT01470781|Other Pre-specified|Functional Magnetic Resonance Imaging (fMRI) (Optional)|resting state, task-based fMRI; Diffusion Tensor Imaging|within 1 week prior to initiating intervention; post-treatment - on average 24 weeks after initiation||2020-12-31|12/2020||||
2672208|NCT01470781|Secondary|Social and Occupational Functioning Assessment Scale|The SOFAS is a 100-point scale similar to the Global Assessment of Functioning designed to evaluate social and occupational functioning not directly influenced by psychological symptom severity. Assessment is based on rater impression and includes a single assigned number. Scores may range from 0-100, with higher scores reflecting better functioning.|within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention|All randomized participants with at least one completed assessment|||units on a scale||Standard Deviation|Mean
2672209|NCT01470781|Secondary|Multnomah Community Ability Scale (MCAS)|The MCAS is an interview-based assessment that measures functioning in psychiatric patients in multiple domains including social interest and effectiveness, independence in daily living, and instrumental role functioning. The present study uses an abbreviated version of the form consisting of 11 total items scored 1-5, with higher scores reflecting better community functioning. The abbreviated version (Lewandowski et al., 2013) was selected because it assesses community functioning independent of cognition or clinical symptoms, which would represent a confound in the present study. Total possible scores range from 11-55, with higher scores reflecting better community functioning.|within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention|All randomized participants with at least one completed assessment|||T-scores||Standard Deviation|Mean
2672210|NCT01470781|Secondary|Positive and Negative Syndrome Scale (PANSS)|"The PANSS is an interview-administered measure assessing positive and negative symptoms of psychosis, and general psychiatric symptoms. The PANSS consists of 30 total items scored 1-7 (least to most severe). Both Positive and Negative sub scales consist of 7 items each for a total possible score of 49 for each sub scale; the General sub scale consists of 16 items for a total possible score of 112. As the lowest possible score is 1, the lower bound of PANSS total score is 30. Higher scores reflect greater symptom severity. Based on the authors' original publication Kay and colleagues reported mean score in a sample of people with schizophrenia as follows:~Positive scale = 18.20 Negative scale = 21.01 General psychopathology = 37.74~Administration = approximately 40 minutes"|within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention|All randomized participants with at least one completed assessment|||units on a scale||Standard Deviation|Mean
2672211|NCT01470781|Secondary|Montgomery-Asberg Depression Rating Scale (MADRS)|The MADRS is an interview-style rating scale to assess severity of symptoms of depression. The MADRS consists of 10 items scored 0-6. Total MADRS scores range from 0-60, with higher score indicates more severe depression. Typical clinical cutoff points are: 0 to 6 - normal/symptom absent; 7 to 19 - mild depression; 20 to 34 - moderate depression; 34 - severe depression. Administration time = 10 minutes|within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention|All randomized participants with at least one assessment|||units on a scale||Standard Deviation|Mean
2672212|NCT01470781|Secondary|Young Mania Rating Scale (YMRS)|The YMRS is an interview style measure asking about hallmark symptoms of mania. Total score ranges from 0 to 60 where higher scores indicate more severe symptoms of mania. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania). Administration time = approximately 10 minutes|within 1 week prior to initiating intervention; midpoint - on average after 8 weeks of initiation; post-treatment - on average 24 weeks after initiation; after 6 months of no active study intervention|All randomized participants with at least one assessment|||units on a scale||Standard Deviation|Mean
2672213|NCT01470781|Primary|MATRICS Consensus Cognitive Battery (MCCB)|The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery includes 10 tasks that are designed to measure seven key cognitive domains: processing speed, attention, working memory, verbal learning, visual learning, problem solving and social cognition. These scores are also combined to yield a cognitive Composite. All subtest, domain, and composite scores are reported in standardized T scores with a mean of 50 and a standard deviation of 10; higher scores reflect better performance. For example, a score of 60 on any subtest, domain, or the Composite would represent a score 1 standard deviation above than the mean. All standardized scores are computed by the MCCB scoring software included in the testing battery, and are normed by age and sex. Total administration time is 60-90 minutes.|within 1 week prior to initiating intervention; midpoint - on average 8 weeks after initiation; post-treatment - on average 24 weeks after initiation; after 6 months no active intervention|84 participants signed consent and met eligibility criteria; however, 12 discontinued prior to completion of the baseline assessment and therefore were not randomized and no data were available; therefore only randomized participants who completed at least one assessment were able to be included in the analyses.|||T-scores||Standard Deviation|Mean
2672214|NCT01470651|Secondary|Fatigue Severity Scale (FSS)|"Fatigue Severity Scale is a 9-item scale measures the impact of fatigue on everyday functioning (e.g. fatigue interferes with my work, family or social life). Response format is a 7-point Likert scale of agreement with a 1-week time frame. Total score is the sum of item scores and ranges from 9 to 63 points, with higher scores indicating greater fatigue. A score greater than 40 is considered to be a clinically significant level of fatigue. Scores on the scale correlate highly with other measures of fatigue, is sensitive to change, and is routinely used in studies of modafinil/armodafinil."|Biweekly for the first month, monthly thereafter||||FSS score (out of 63)||Standard Deviation|Mean
2672215|NCT01470651|Primary|Adherence to Medications Form|The Medication Adherence Form was designed to assess any HCV medication dosing changes, including discontinuation, and the reasons for the changes. The form asks specifically about the HCV medications: pegylated interferon, ribavirin and Incivek (or Victrelis), as well as the study medication, armodafinil.|HCV medication adherence reported at 12 weeks|Not all patients were given all medications, subjects are not factored in if they were not told to take a given drug.|||Percentage of doses missed||Standard Error|Mean
2672216|NCT01470599|Secondary|Length of Hospitalizations Due to Crohn's Disease|The length of hospitalizations due to Crohn's disease were recorded at every study visit.|From baseline to Week 52/follow-up|SAS|||Percentage of participnats|||Number
2672217|NCT01470599|Primary|Adjudicated Interstitial Lung Disease (ILD) Events|Pre-specified ILD events were adjudicated by committees of external experts who were blinded to treatment assignment. pEoI were identified by searches of the clinical, safety & laboratory databases (AEs coded to the MedDRA ILD SMQ and events nominated by the study clinician or clinical lead). The IRs determined if the pEoI met the criteria for EoI classification by assessment of the ILD event (probably ILD, possible ILD, alternative diagnosis likely, other or insufficient information to classify).|From baseline to Week 52|Participants in the SAS who had pEoI and were adjudicated by IRs||||||
2672218|NCT01470599|Primary|Adjudicated Gastrointestinal (GI) Perforation Events|Pre-specified GI perforation events were adjudicated by committees of external experts who were blinded to treatment assignment. The pEoI were identified via search of AE/SAE listings using the MedDRA GI Perforation SMQ. The IRs determined if the pEoI met the criteria for EoI classification based on whether a GI perforation occurred and if yes, the location within the GI tract, possible contributing medical conditions and/or concomitant medications.|From baseline to Week 52|Participants in the SAS who had pEoI and were adjudicated by IRs|||Number of events meeting criteria|||Number
2672249|NCT01470469|Primary|Change From Baseline in Pulse Rate at Up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||beats/min||Standard Deviation|Mean
2672250|NCT01470469|Primary|Change From Baseline in Diastolic Blood Pressure at Up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
2672219|NCT01470599|Primary|Adjudicated Opportunistic Infection Events|Pre-specified opportunistic infection events were adjudicated by blinded committees of external experts. pEoI were identified by investigator, sponsor & search of SAE listings for serious infections coded to MedDRA infections & infestations SOC &/or events meeting pre-specified criteria for IR pre-screening to determine if adjudication is required. IRs determined if the pEoI met the criteria for EoI classification according to definitions for opportunistic infections (invasive fungal infections per the European Organization for Research & Treatment of Cancer/Invasive Fungal Infections Cooperative Group & the National Institute of Allergy & Infectious Diseases Mycoses Study Group [EORTC/MSG] Consensus Group definitions, endemic fungal infections per the EORTC/MSG Consensus Group definitions, other fungal infections, viral, bacterial & parasitic infections & vaccine dissemination) & special interest infections (actinomycosis, Legionella & mononucleosis-like toxoplasmosis).|From baseline to Week 52|Participants in the SAS who had pEoI and were adjudicated by IRs|||Number of events meeting criteria|||Number
2672220|NCT01470599|Primary|Adjudicated Hepatic Injury Events|Pre-specified liver injury events were adjudicated by blinded committees of external experts. pEoI were identified by investigator, sponsor & search of clinical, safety & laboratory databases (potential Hy's law event, ALT/AST ≥5 x ULN, events meeting hepatic discontinuation criteria, SAEs coded to MedDRA hepatobiliary system organ class (SOC), AEs/SAEs coded to MedDRA liver infections or infectious biliary disorders SMQ, AEs coded to MedDRA drug-induced liver injury (DILI) preferred term or any death with ALT or AST ≥3xULN, bilirubin ≥2xULN or jaundice). IRs determined if the pEoI met the criteria for EoI classification by assessing DILI (definite, highly likely, probable, possible, unlikely, unrelated or undetermined), pattern (hepatocellular, mixed, cholestatic or undetermined), likely, competing or alternative cause(s), severity (mild, moderate, severe, fatal/transplantation or undetermined), Hy's law case, recovery & liver failure (all yes, no or undetermined).|From baseline to Week 52|Participants in the SAS who had pEoI and were adjudicated by IRs|||Number of events meeting criteria|||Number
2672221|NCT01470599|Secondary|Percentage of Participants Hospitalized Due to Crohn's Disease|The number of participants hospitalized due to Crohn's disease were recorded at every study visit.|From baseline to Week 52/follow-up|SAS|||Percentage of participants|||Number
2672222|NCT01470599|Secondary|Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit|EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline and Week 48/ET visit|Participants in the FAS who had non-missing data at Week 48/ET visit|||mm||Standard Deviation|Mean
2672223|NCT01470599|Secondary|EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit|EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. n = number of participants with non-missing data.|Baseline and Week 48/ET visit|FAS|||mm||Standard Deviation|Mean
2672224|NCT01470599|Secondary|Change From Baseline EQ-5D Utility Scores at Week 48/ET Visit|"EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from 0.594 to 1.000; a higher score indicates a better health state."|Baseline and Week 48/ET visit|Participants in the FAS who had non-missing data at Week 48/ET visit|||Score on a scale||Standard Deviation|Mean
2672225|NCT01470599|Secondary|EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 48/ET Visit|"EQ5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, selfcare, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from 0.594 to 1.000; a higher score indicates a better health state. n = number of participants with non-missing data."|Baseline and Week 48/ET visit|FAS|||Score on a scale||Standard Deviation|Mean
2672226|NCT01470599|Secondary|Change From Baseline SF-36 Component and Domain Scores at Week 48/ET Visit|The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QoL. n = number of participants with non-missing data.|Baseline and Week 48/ET visit|FAS|||Score on a scale||Standard Deviation|Mean
2672227|NCT01470599|Secondary|Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 48/ET Visit|The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QoL. n = number of participants with non-missing data.|Baseline and Week 48/ET visit|FAS|||Score on a scale||Standard Deviation|Mean
2672228|NCT01470599|Secondary|Percentage of Participants With a Response to the Patient-Reported Treatment Impact (PRTI) Assessment at Week 48/ET Visit by Category|The IBD PRTI modified questionnaire comprises 3 individual questions administered to the participant: participant satisfaction with study treatment; participant preference for study drug over prior treatment (this question on participant preference for study drug is prefaced by a simple question of previous treatment/s for IBD received in order to place the preference question into context) and participant willingness to reuse the study treatment again. Each of these questions (except the question on previous treatment, which is informational only) is scored on a 5 point Likert scale. PSA = Patient Satisfaction Assessment; PPTA = Patient Previous Treatment Assessment; PPA = Patient Preference Assessment; PWA = Patient Willingness Assessment.|Week 48/ET visit|Participants in the FAS who had a response to PRTI assessment at Week 48/ET visit|||Percentage of participants|||Number
2672229|NCT01470599|Secondary|Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 48/ET Visit|The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QoL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. A score ≥170 corresponds to clinical remission. 95% Clopper-Pearson exact confidence interval reported for the proportions.|Week 48/ET|Participants in the FAS who had non-missing data at Week 48/ET visit|||Percentage of participants||95% Confidence Interval|Number
2672230|NCT01470599|Secondary|Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 48/ET Visit|The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QoL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QoL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. Positive change in total score indicated improvement in QoL.|Baseline and Week 48/ET|Participants in the FAS who had non-missing data at Week 48/ET visit|||Score on a scale||Standard Deviation|Mean
2672231|NCT01470599|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 48/ET Visit|The IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QoL) in participants with inflammatory bowel disease (IBD). IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QoL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QoL. Positive change in total score indicated improvement in QoL. n = number of participants with non-missing data.|Baseline and Week 48/early termination (ET)|FAS|||Score on a scale||Standard Deviation|Mean
2672232|NCT01470599|Secondary|Observed Change From Baseline in High Sensitivity C-reactive Protein (CRP) by Week|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. n = number of participants with non-missing data.|Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up|FAS|||mg per liter (mg/L)||Standard Deviation|Mean
2672233|NCT01470599|Secondary|Observed Change From Baseline in Fecal Calprotectin by Week|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation. n = number of participants with non-missing data.|Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up|FAS|||mg per kilogram (mg/kg)||Standard Deviation|Mean
2672234|NCT01470599|Secondary|Percentage of Participants Switching From 5 mg BID to 10 mg BID or 10 mg BID to 5 mg BID After Initial Assignment by Visit|There was a single study treatment dose adjustment allowed, at the discretion of the Investigator, from 5 mg BID to 10 mg BID or from 10 mg BID to 5 mg BID, after the initial 8 weeks of fixed open label treatment and for the remaining treatment period of 40 weeks. Percentage of participants whose study treatment were switched from 5 mg BID to 10 mg BID or 10 mg BID to 5 mg BID after initial assignment was reported.|From baseline to Week 48|FAS|||Percentage of participants|||Number
2672235|NCT01470599|Secondary|Corticosteroid Use Over Time|Use of corticosteroids (yes or no) was recorded at baseline and throughout the study. Percentage of participants taking corticosteriod at each visit was reported.|Weeks 8, 16, 24, 36 and 48|SAS|||Percentage of participants|||Number
2672236|NCT01470599|Secondary|Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 48 - Among Subjects on Steroids at A3921086 Baseline|Steroid-free clinical remission at Week 48 was a CDAI <150 points in participants who were steroid-free at Week 48. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Week 48|Participants in FAS who were on steroids at baseline of this study|||Percentage of participants||95% Confidence Interval|Number
2672237|NCT01470599|Secondary|Change From Baseline Observed CDAI Score by Week|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. n = number of participants with non-missing data.|Weeks 8, 16, 24, 36, 48 and 52/follow-up|FAS|||Score on a scale||Standard Deviation|Mean
2672238|NCT01470599|Secondary|Observed CDAI Score by Week|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. n = number of participants remaining at risk.|Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up|FAS|||Score on a scale||Standard Deviation|Mean
2672251|NCT01470469|Primary|Change From Baseline in Systolic Blood Pressure at Up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
2672252|NCT01470417|Secondary|90 Day Post-operative Mortality|Evaluate mortality in the first 90 days after surgery|90 days after surgery||||participants|||Number
2674433|NCT01455519|Secondary|Change in Sit to Stand Repetitions|Sit to stand repetitions completed in 1 minute|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||number of repetitions||Standard Error|Mean
2672239|NCT01470599|Secondary|Time to Relapse Among Participants in Clinical Remission at Baseline|"Relapse was defined as an increase in CDAI of more than (>) 100 points from the baseline and an absolute CDAI score of >220 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Data presented are rates estimated from Kaplan-Meier curves.~n = number of participants remaining at risk."|From baseline to Week 52|Participants in the FAS who met clinical remission criteria at baseline of this study|||Percentage of participants||95% Confidence Interval|Number
2672240|NCT01470599|Secondary|Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Response (CDAI-100 Response) or Clinical Remission at Baseline of This Study|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of <150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. Clinical response was defined as a CDAI score reduction of at least 100 points from the A3921083 study baseline value. 95% Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.|Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up|Participants in the FAS who met clinical response or clinical remission criteria at baseline of this study|||Percentage of participants||95% Confidence Interval|Number
2672241|NCT01470599|Secondary|Percentage of Participants in Clinical Remission and Sustained Clinical Remission Among Participants in Clinical Remission at Baseline of This Study|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of <150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. 95% Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.|Baseline and Weeks 8, 16, 24, 36, 48 and 52/follow-up|Participants in the FAS who met clinical remission criteria at baseline of this study|||Percentage of participants||95% Confidence Interval|Number
2672242|NCT01470599|Secondary|Percentage of Participants in Clinical Remission and Sustained Clinical Remission at Week 48|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, intensity of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. Clinical remission was defined as a CDAI score of less than (<) 150. Sustained clinical remission was defined as being in clinical remission (CDAI score <150) at both Week 24 and Week 48. 95 percent (%) Clopper-Pearson exact confidence interval reported for the proportions. n = number of participants with non-missing data.|Week 48|Full analysis set (FAS) - consisted of all participants enrolled in this OL extension study.|||Percent||95% Confidence Interval|Number
2672243|NCT01470599|Primary|Adjudicated Malignancy Events|Pre-specified malignancy events were adjudicated by committees of external experts who were blinded to treatment assignment. pEoI were identified by the investigator, sponsor, potential primary event notifications (i.e. malignancies excluding non-melanoma skin cancers) for a specific protocol, events submitted for histopathology review for potential malignancies which met the criteria for potential malignancies, and by search of AE/SAE listings for events coded to Malignant tumors Standard Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQ) (20000194). IRs determined if the pEoI met the criteria for EoI classification according to the International Classification of Diseases for Oncology, a ten-digit multi-axial classification of the site (4 characters), morphology (4 digits), behavior (1 digit), and grading (1 digit) of neoplasms.|From baseline to Week 52|Participants in the SAS who had pEoI and were adjudicated by IRs|||Number of events meeting criteria|||Number
2672244|NCT01470599|Primary|Adjudicated Potential Cardiovascular Events|Pre-specified cardiovascular events were adjudicated by committees of external experts who were blinded to treatment assignment. Potential events of interest (pEoI) were identified by the investigator, sponsor, review of alerts from central electrocardiogram assessments, and by search of adverse events (AE)/serious adverse event (SAE) listings for events coded to death (coronary and non-coronary), myocardial infarction (non-fatal), all coronary revascularization, unstable angina, stroke (fatal and non-fatal), transient ischemic attack, congestive heart failure, peripheral arterial vascular disease, dyspnoea, and chest pain. The independent reviewers (IRs) determined if the pEoI met the criteria for EoI classification according to the definitions summarized from the Clinical Data Interchange Standards Consortium 'Standardized Definitions for End Point Events in Cardiovascular Trials' published October 2010.|From baseline to Week 52|Participants in the SAS who had pEoI and were adjudicated by IRs|||Number of events meeting criteria|||Number
2672245|NCT01470469|Primary|Change From Baseline in ECG QTcF Interval at up to 12 Weeks|The QT interval is the time from the start of the Q wave to the end of the T wave. It is a portion of the ECG tracing that represents the time taken for ventricular depolarisation and repolarisation. The QTcF includes a correction factor to help account for changes in heart rate.|Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||Standard Deviation|Mean
2672246|NCT01470469|Primary|Change From Baseline in Electrocardiogram (ECG) QRS Interval at up to 12 Weeks|QRS complex is a portion of the ECG tracing that represents depolarization of the ventricular myocardium.|Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||msec||Standard Deviation|Mean
2672247|NCT01470469|Primary|Change From Baseline in Weight at up to 12 Weeks||Baseline and up to 12 weeks|Safety Analysis Set consisted of all subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||kg||Standard Deviation|Mean
2672254|NCT01470417|Primary|Radiographic Response Rate|Evaluate radiographic response of the measurable disease with repeat imaging at 4 - 8 weeks after therapy. Measurable disease was evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1 criteria. Per RECIST v1.1 in target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), >20% growth in the sum of the longest diameter or target lesions or appearance of new lesions; Stable Disease (SD), change in sum of longest diameter of target lesions does not meet criteria for PR or PD. The number of subjects experiencing Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD) is reported.|4 - 8 weeks after neoadjuvant therapy|All subjects enrolled in the study were included in this analysis.|||participants|||Number
2672255|NCT01470417|Primary|Biochemical Response Rate|Biochemical response rate (serum CA 19-9). Baseline compared to pre-operative serum CA19-9 values.|4 - 8 weeks after neoadjuvant therapy|The seven subjects included in this analysis had CA19-9 testing performed at baseline and again prior to surgery. Pre-operative CA19-9 testing was not performed for one subject so they were not included in this analysis nor were two subjects who were found to have progressive disease prior to completing neoadjuvant therapy.|||U/mL||Full Range|Mean
2672256|NCT01470326|Secondary|Number of Participants With Treatment-Related Adverse Events by Use of Concomitant Medication|A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use concomitant medications to assess whether they were risk factors for the occurrence of treatment-related adverse events.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.|||Participants|||Number
2672257|NCT01470326|Primary|Number of Participants With Any Fracture|"Occurrence of any fracture after Viviant administration was examined to evaluate effectiveness of Viviant. The event of fracture was defined as an event which included fracture in Preferred Term (PT) or Lowest Level Term (LLT) of the MedDRA/J version 18.1."|3 years|The effectiveness analysis set was identical with the safety analysis set which comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.|||Participants|||Count of Participants
2672258|NCT01470326|Secondary|Number of Participants With Treatment-Related Adverse Events by Use of Previous Medication|A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use of previous medications to assess whether they were risk factors for the occurrence of treatment-related adverse events.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.|||Participants|||Number
2672259|NCT01470326|Secondary|Number of Participants With Treatment-Related Adverse Events by Use of Steroid|A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by the use of steroid to assess whether it was a risk factor for the occurrence of treatment-related adverse events.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.|||Participants|||Number
2672260|NCT01470326|Secondary|Number of Participants With Treatment-Related Adverse Events by Smoking Status|A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment related-adverse events were counted by smoking status to assess whether it was a risk factor for the occurrence of treatment-related adverse events.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.|||Participants|||Number
2672261|NCT01470326|Secondary|Number of Participants With Treatment-Related Adverse Events by Age|A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Relatedness to Viviant was assessed by the physician. Participants with treatment-related adverse events were counted by age to assess whether it was a risk factor for the occurrence of treatment-related adverse events.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.|||Participants|||Number
2672262|NCT01470326|Secondary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to Viviant was assessed by the physician.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.|||Participants|||Number
2672263|NCT01470326|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to Viviant in a participant who received Viviant. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Viviant was assessed by the physician.|3 years|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Viviant at least once.|||Participants|||Count of Participants
2672264|NCT01470248|Secondary|Overall Survival|Duration of time from enrollment on study until death|From enrolment till death on average up to 2 years|Two patients were not analyzed because only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated were considered evaluable for response.|||months||Full Range|Median
2672301|NCT01469819|Secondary|Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients.|Changes in Time of GE, SB, LB and WG transits measured by SmartPill after 2 weeks of lubiprostone 24mcg BID in chronically constipated patients who increased stool frequency to ≥ 2 times increase per week vs. patients who increased stool frequency < 2 times increase per week.|Measured at baseline and 2 weeks after baseline.||||Hours||Standard Error|Mean
2672265|NCT01470248|Secondary|Progression-free Survival|"Defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).~Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm."|Every 8 weeks|Two patients were not analyzed because only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated were considered evaluable for response.|||weeks||Standard Deviation|Mean
2672266|NCT01470248|Primary|Clinical Benefit Rate (CBR)|Sum of complete response (CR), partial response (PR) and stable disease (SD) in patients eligible for efficacy analysis.|After completing at least 1 cycle (8 weeks) of treatment|An alternative endpoint of clinical benefit rate was pre-specified in the event that the study failed to meet its overall response rate (ORR) endpoint either at the end of stage I accrual or at final analysis. However, this study met its endpoint. Please see primary outcome measure 1.||||||
2672267|NCT01470248|Primary|Response Rate (RR)|"Response rate (complete response [CR]+ partial response [PR]) was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).~Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.~Partial response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.~Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|Every 8 weeks|Two patients were not analyzed because only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated were considered evaluable for response.|||Participants|||Count of Participants
2672268|NCT01470196|Primary|Very Good Partial Response and Complete Response Rate|This is the rate of VGPR and CR in patients on CaRD therapy. Very good partial responses are >90% reduction in serum IgM from baseline. Complete response is defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, and resolution of any adenopathy or splenomegaly.|4 years||||Participants|||Count of Participants
2672269|NCT01470196|Primary|Major Response Rate|Major Response Rate= Partial Response (>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).|4 years||||Participants|||Count of Participants
2672270|NCT01470196|Primary|Time to Progression|Progression-free survival is the defined as the time from study entry to disease progression (PD) or death. Patients without PD are censored at the date of last disease evaluation. PD is defined as a greater than 25% increase in serum IgM and 500mg/dL absolute increase from the lowest attained response value as determined by serum electrophoresis, confirmed by at least one other investigation, or progression of clinically significant disease related symptom(s).|4 years||||months||Inter-Quartile Range|Median
2672271|NCT01470196|Primary|Neuropathy Incidence Rate|Number and percentage of participants who experienced neuropathy attributable to CaRD therapy|3 years||||Participants|||Count of Participants
2672272|NCT01470196|Primary|Overall Response Rate|Overall Response Rate= Minor response (>25%-50% reduction in serum IgM from baseline + Partial Response (>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).|4 years||||Participants|||Count of Participants
2672273|NCT01470170|Secondary|Hypotension|Check the frequency of hypotension episode during induction, procedure and recovery time|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours||||participants|||Number
2672274|NCT01470170|Secondary|Hypoxemia|Check the frequency of hypoxemia episode during induction, procedure, and recovery time|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours||||participants|||Number
2672275|NCT01470170|Primary|Induction Time, Time Period That Will be Required for Conscious Level to Reach OAAS-3|After the administration of Alfentanil and Propofol, the time period required to reach conscious level OAAS-3 will be recorded.|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours||||second||Standard Deviation|Mean
2672276|NCT01470170|Primary|Propofol Dose Needed to Reach Conscious Level OAAS-3|After the administration of Alfentanil and Propofol, the Propofol dose needed to reach conscious level of observer assessment of alertness and sedation scale 3 (OAAS-3) will be recorded.|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours||||mg||Standard Deviation|Mean
2672277|NCT01470170|Primary|Effect Site Concentration When Conscious Level Reaches OAAS-3|After the administration of alfentanil and propofol, the effect site concentration was recorded at the time when the consciousness level reaches observer assessment of alertness and sedation scale 3 (OAAS-3). The effect site concentration is the concentration of drug propofol in brain calculated by TCI using Schnider model.|All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours||||ug/ml||Standard Deviation|Mean
2672278|NCT01470144|Secondary|Exposure Duration|Duration of exposure to EFI|On average 2.72 years||||year||Full Range|Median
2672279|NCT01470144|Primary|Treatment-emergent Adverse Events||On average 2.72 years|All patients who received at least one dose of EFI|||Number of patients|||Number
2672302|NCT01469819|Secondary|Changes in Number of Bowel Movements in Chronically Constipated Patients After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day (BID).||Measured at baseline and 2 weeks after baseline||||number per week||Standard Error|Mean
2672280|NCT01470118|Primary|Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24|Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects|||Scores on a Scale||Standard Deviation|Mean
2672281|NCT01470118|Secondary|Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Tearing evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less tearing.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects|||Scores on a Scale||Standard Deviation|Mean
2672282|NCT01470118|Secondary|Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Eyelid swelling evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored eyelid swelling on a numeric analog 4-point scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less lid swelling.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects|||Scores on a Scale||Standard Deviation|Mean
2672283|NCT01470118|Secondary|Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Chemosis evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored chemosis on a numeric analog scale ranging from 0=None to 4=Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less chemosis.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects|||Scores on a Scale||Standard Deviation|Mean
2672284|NCT01470118|Secondary|Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Episcleral redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored episcleral redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less episcleral redness.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects|||Scores on a Scale||Standard Deviation|Mean
2672285|NCT01470118|Secondary|Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Ciliary redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored ciliary redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less ciliary redness.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects|||Scores on a Scale||Standard Deviation|Mean
2672286|NCT01470118|Secondary|Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24|Conjunctival redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored conjunctival redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less conjunctival redness.|Day 14 Hour 24|Intent-to-Treat: All randomized subjects|||Scores on a Scale||Standard Deviation|Mean
2672287|NCT01470118|Primary|Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16|Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.|Day 0 Hour 16|Intent-to-Treat: All randomized subjects|||Scores on a Scale||Standard Deviation|Mean
2672288|NCT01470027|Secondary|Parkinson's Disease Quality of Life Questionnaire (PDQLQ)|"The Parkinson's Disease Quality of Life Questionnaire is a self completion PRO designed to address aspects of functioning and well-being for those affected by Parkinson's disease.~The Parkinson's Disease Quality of Life Questionnaire is coded on a scale of 0 to 185, with 185 indicating perfect health and 0 indicating very poor health."|at baseline and 4 weeks after intervention start|The number of participants in the Participant Flow module is different from the Overall Number of Participants for PDQLQ because of the total sample of 47 subjects enrolled in the study, baseline and post-treatment PDQLQ scores were available only for 43 subjects, whose data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2672289|NCT01470027|Secondary|Beck Anxiety Inventory|"The Beck Anxiety Inventory (BAI) is a clinician-administered and validated instrument to discriminate anxiety from depression. The standardized BAI cutoffs are:~0-9: minimal anxiety; 10-16: mild anxiety; 17-29: moderate anxiety; 30-63: severe anxiety."|at baseline and 4 weeks after intervention start|The number of participants in the Participant Flow module is different from the Overall Number of Participants for Beck Anxiety Inventory (BAI) test because of the total sample of 47 subjects enrolled in the study, baseline and post-treatment BAI scores were available only for 45 subjects, whose data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2672290|NCT01470027|Secondary|10-Meter Walk Test|"The 10-meter walk test is a standardized, quantitative timed test of lower body motor function. The maximal gait speed is measured during a 10-meter walk. The task will be performed three times and the average time to complete the task once will be recorded. The 10-meter walk test is a reliable and sensitive measure of gait function in elderly individuals and PD patients.~Cut-off values:~< 0.4 m/s more likely to be household ambulators; 0.4 - 0.8 m/s limited community ambulators; > 0.8 m/s community ambulators."|at baseline and 4 weeks after intervention start|The number of participants in the Participant Flow module is different from the Overall Number of Participants for 10-Meter Walk Test because of the total sample of 47 subjects enrolled in the study, baseline and post-treatment 10-Meter Walk Test score were available only for 46 subjects, whose data were included in the analysis.|||m/s (meters per second)||Standard Deviation|Mean
2672291|NCT01470027|Secondary|9-Hole Peg Board Test (9-HPT)|The 9-HPT is a standardized, quantitative timed test of upper extremity motor function. Individuals are asked to place and remove nine pegs, one at a time, from nine holes in a board as quickly as possible. The task is performed twice with the dominant and twice with the non-dominant hand, and the average time to complete the task once is calculated for each hand. The 9-HPT has a high inter- and intra-rater reliability, is validated and is sensitive to detect minor impairments of hand function.|at baseline and 4 weeks after intervention start|The measurement used for the 9-HPT is the average of time needed to complete the task with the dominant and non-dominant hand recorded in seconds. The presence of PD is expected to produce higher test times in seconds.|||s (in seconds)||Standard Deviation|Mean
2672292|NCT01470027|Secondary|Hamilton Depression Rating Scale (HAM-D)|"The Hamilton Depression Rating Scale (HAM-D) is a 21-item instrument designed to measure the severity of illness in adults already diagnosed as having depression. The Hamilton Depression Rating Scale (HAM-D) has proven useful for many years as a way of determining a patient's level of depression before, during, and after treatment. It is clinician-administered and requires 15 to 20 minutes complete the interview and score the results. Although the HAM-D form lists 21 items, the scoring is based on the first 17. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.~The minimum score is 0 and maximum score is 50. The scale has been widely used in clinical practice and become a standard in pharmaceutical trials.~HAM-D Scoring Instructions are following:~0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression;~≥ 23 = Very Severe Depression."|at baseline and 4 weeks after intervention start||||units on a scale||Standard Deviation|Mean
2672293|NCT01470027|Secondary|Mini Mental State Examination (MMSE)|The MMSE is a brief questionnaire-based test that is used to screen for cognitive impairment. Domains tested are orientation to time and place, registration, attention and calculation, recall, language, repetition and complex commands. Scores lower than 25/30 points indicate mild (21-24 points), moderate (10-20 points) or severe (<10 points) cognitive impairment, but scores may need to be corrected for educational attainment, age and interfering impairments such as motor deficits that affect drawing skills.|at baseline and 4 weeks after intervention start||||units on a scale||Standard Deviation|Mean
2672294|NCT01470027|Secondary|Unified Parkinson's Disease Rating Scale (UPDRS) Parts I-V (Total Score Reported)|"The UPDRS is considered the gold standard for determining disease severity and progression in patients with Parkinson's disease. It consists of the following five elements:~Evaluation of mentation, behavior and mood.~Self evaluation of the activities of daily living (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, etc.~Motor evaluation by a clinician.~Hoehn and Yahr scale (Hoehn 1967) for the description of the overall disease severity in PD with 8 stages.~Schwab and England activities of daily living scale (Schwab and England 1969) for the estimation of the general abilities in PD patients. The Schwab and England ADL scale is graduated in 10% steps with 100% indicating complete independence and 0% indicating an individual in whom the vegetative functions are completely impaired.~A total of 199 points are possible for UPDRS, with 199 representing the worst disability and 0 no disability."|at baseline and 4 weeks after intervention start|The number of participants in the Participant Flow module is different from the Overall Number of Participants for Unified Parkinson's Disease Rating Scale (UPDRS) because of the total sample of 47 subjects enrolled in the study, baseline and post-treatment UPDRS were available only for 40 subjects, whose data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2672295|NCT01470027|Primary|Change of Cerebral Glutathione Levels as Measured by Proton Magnetic Resonance Spectroscopy|"In vivo brain GSH measured with 1H MRS in the unmedicated patients with idiopathic PD and in sex- and age-matched healthy controls prior to and following 4 weeks supplementation with either placebo, 1800mg/day or 3600 mg/day of NAC. Striatal and occipital cortex glutathione levels as measured in vivo by 1H MRS at baseline and following 4 weeks of treatment with placebo, 1800mg NAC/day and 3600mg NAC/day.~The area under the GSH spectral peak was obtained by frequency-domain fitting of the GSH resonance in the edited spectrum to a pseudo-Voigt lineshape function using a robust and highly optimized public-domain Levenberg-Marquardt nonlinear least-squares minimization routine. The resulting peak areas were then expressed as ratios relative to the synchronously acquired and similarly fitted unsuppressed voxel water signal."|at baseline and 4 weeks after intervention start|The number of participants in the Participant Flow module is different from the Overall Number of Participants for brain GSH levels because of the total sample of 47 subjects enrolled in the study, baseline and post-treatment GSH values were available only for 43 subjects, whose data were included in the analysis.|||Ratio||Standard Deviation|Mean
2672296|NCT01470001|Secondary|Change in Patients Perspective of the Impact of Their Disease, Captured Using the Pelvic Floor Distress Inventory (Urinary Questions)|"The difference between baseline and follow up (last 20 days on drug) scores was the recorded measure. The larger the negative # the greater the effect.~The survey was divided into 3 sections, each section worth 100 points. Total scores could range from 0 to 300 (0 no disease, 300 severe disease)."|outcome measures will be assessed at week 0 (baseline), and compared to an average measure of the last 20 days on placebo or treatment|one subject was excluded from analysis because of missing baseline data|||change in score||Full Range|Mean
2672297|NCT01470001|Secondary|the Percent of Patients With at Least 50% Reduction in Post Void Dribbling Episodes||outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12|one study subject was excluded form analysis due to missing baseline data|||percent|||Number
2672298|NCT01470001|Primary|The Percent Reduction in Post Void Dribbling Episodes (Events)||outcome measures will be assessed at week 0 (baseline), and compared to an average measure of weeks 10 through 12|one subject was excluded from analysis because of missing baseline data|||percent reduction||Full Range|Mean
2672299|NCT01469819|Secondary|Elimination of Small Intestine Bacterial Overgrowth (SIBO) in Chronically Constipated Patients Treated With Lubiprostone 24mcg Twice a Day for 2 Weeks.||Measured at baseline and 2 weeks after baseline.||||participants|||Number
2672300|NCT01469819|Secondary|Changes in Number of Bowel Movements Per Week Changes GE, SB, LB and WG Transit Times Measured by SmartPill in Chronically Constipated Patients Treated for 2 Weeks With Lubiprostone 24mcg Twice a Day.||Measured at baseline and 2 weeks after baseline.|Number of Bowel Movements per week|||number per week||Standard Error|Mean
2674434|NCT01455519|Secondary|Change in Treadmill Distance Walked|Treadmill distance walked in 6 minutes|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||miles||Standard Error|Mean
2672303|NCT01469819|Primary|Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically Constipated Patients Before and After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day.|The change in transit time (TT), in hours and minutes, of gastric emptying (GE), small bowel (SB), large bowel (LB) and whole gut (WG) measured by SmartPill in 29 patients with chronic constipation after taking lubiprostone 24 micrograms twice a day (BID) for 2 weeks.|Measured at baseline and 2 weeks after baseline.||||Hours||Standard Error|Mean
2672304|NCT01469767|Secondary|VAS|"Visual Analog Scale for itch: A 100 millimeter (mm) Visual Analog Scale (VAS) will be used to measure itch intensity. VAS is a self-report tool that is designed to present to the respondent a rating scale with minimum constraints. VAS data is recorded as the number of mm from the left of the line with the range 0-100 mm. The Visual Analog Scale is anchored with the verbal descriptions of no itch on the left and the most intense itch imaginable on the right."|14 days||||units on a scale||Full Range|Mean
2672305|NCT01469767|Secondary|BSA|Body Surface Area of atopic dermatitis. The BSA is measured as the total percent of the entire body with atopic dermatitis involved, so the scores range from 0% to 100% of total body involvement.|14 days||||Percent BSA||Full Range|Mean
2672306|NCT01469767|Secondary|EASI|"Eczema Area and Severity Index Score:Disease severity will be assessed with the Eczema Area and Severity Index (EASI).This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions and scores erythema, excoriation, induration/papulation, and lichenification. The total are summed for one total EASI score. .The total scores range from 0 (no Eczema) -72 (most severe Eczema)."|14 days||||units on a scale||Full Range|Mean
2672307|NCT01469767|Secondary|Actigraphy|Actigraphy Movement Count per Hour:Subjects will be asked to wear an actigraphy monitor on each wrist for the duration of the 14-day study. These monitors appear and function similarly to a wristwatch. The actigraph provides a continuous measure of wrist activity and may be used to quantify nocturnal scratching behavior. A piezoelectric accelerometer records the integration of intensity, amount, and duration of stimuli in all 3 dimensions of wrist movement. Measurements are taken at 32 Hz and a summation value is recorded at the end of each 30-second epoch. The number of 30-second epochs with movement (in which acceleration was detected irrespective of the magnitude of the acceleration) is recorded and summed to give a movement score. This is divided by the duration of time in bed to produce a movement count per hour, which is a sensitive quantitative measure of scratch-associated activity.|14 days||||Movement count per hour||Standard Deviation|Mean
2672308|NCT01469767|Primary|IGA|Investigator's Global Assessment of atopic dermatitis integrates all lesions for overall score. This measure is commonly used to quantify disease severity and most resembles assessments performed in the clinic setting. Score ranges from '0' = Clear to '5' = Very Severe Disease|14 days||||units on a scale||Full Range|Mean
2672309|NCT01469715|Primary|Absolute Relative Difference (ARD)|"ARD=100*(G_sensor-G_reference)/G_reference~Calculated for when patient's G_ref was Normal (70-180 mg/dl), Hyperglycemic (>180 mg/dl) and Hypoglycemic (<70 mg/dl)~The study data includes 208 paired sensor-YSI plasma glucose readings (G_reference) for each GBP CGM sensor (G_sensor) inserted for 24 hours during hyperglycemic and hypoglycemic challenge conditions. Data pairs will permit the detailed evaluation of sensor performance parameters, including static accuracy metrics such as median and mean absolute deviations and median and mean absolute relative deviation and Point CG-EGA, as well as dynamic parameters, such as warm-up time, trend accuracy (Rate CG-EGA), and sensor lag."|25.5 hours||||percentage of error|||Number
2672310|NCT01469637|Primary|Maximum Plasma Concentration at Steady-State (Cmaxss) for Sulfamethoxazole|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.|||ug/ml||Standard Deviation|Mean
2672311|NCT01469637|Primary|Area Under the Plasma Concentration Versus Time Curve Within a Dosing Interval at Steady-State (AUCss) for Sulfamethoxazole|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure of how much and how long a drug stays in a body.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.|||h*ug/ml||Standard Deviation|Mean
2672312|NCT01469546|Secondary|Median Progression-Free Survival (PFS)Time|To evaluate PFS time in patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN) treated with Axitinib.|6 months|42 patients were enrolled. 12 patients did not complete the first cycle or undergo repeat tumor imaging (due to adverse event, disease progression, non-compliance or physician discretion). Only 30 patients were analyzed.|||months||95% Confidence Interval|Number
2672313|NCT01469546|Secondary|Number of Patients That Experienced Grade 3 or 4 Toxicities|The number of patients who develop these while on treatment and for 28 days after cessation of axitinib, and graded in severity per CTCAE v. 3.0 and as described in the protocol. According to the CTCAE v. 3.0, grade 3 toxicities are severe and grade 4 toxicities are life-threatening or disabling.|28 Days Post Treatment|All patients that received at least one dose of treatment were analyzed for toxicity.|||patients|||Number
2672314|NCT01469546|Secondary|Number of Participants Who Achieved Complete Response, Partial Response or Stable Disease|"To determine the disease control rate (complete response+partial response+stable disease), in patients with unresectable recurrent and metastatic head and neck cancer treated with Axitinib.~Response Evaluation Criteria in Solid Tumors (RECIST version 1.0) will be used.~Complete Response is defined as the disappearance of all tumor for a period of one month.~Partial Response is defined as a 30% or more decrease in the sum of the longest diameters (LD) of all measured lesions without any evidence of progression of any lesion or the appearance of any new lesion for a period of one month.~Stable Disease is defined as any change in measurable disease which is less than the criteria for partial remission or progression without any evidence of new lesions and persisting for at least 2 evaluations or 2 months."|2 years|42 patients were enrolled. 12 patients did not complete the first cycle or undergo repeat tumor imaging (due to adverse event, disease progression, non-compliance or physician discretion). Only 30 patients were analyzed.|||participants|||Number
2672315|NCT01469546|Primary|Percentage of Patients Alive and Free of Progression at 6 Months|To determine the 6-months progression-free survival (PFS) rate in patients with unresectable recurrent and metastatic head and neck cancer treated with Axitinib.|6 months|42 patients were enrolled. 12 patients did not complete the first cycle or undergo repeat tumor imaging (due to adverse event, disease progression, non-compliance or physician discretion). Only 30 patients were analyzed.|||percentage of patients|||Number
2672316|NCT01469377|Secondary|Change From Baseline in the Sheehan Disability Scale (SDS) Total Score at Week 8|The SDS measures an individual's perception of the extent to which his or her emotional symptoms are disrupting his or her functioning in 3 domains, work/school, social life/leisure activities, and family life/home responsibilities. The participant is asked to rate the degree to which their functioning is impaired on an 11-point scale, ranging from 0 (not at all) to 10 (extremely). Scores of 0 to 3 indicate mild functional impairment, 4 to 6 indicate moderate functional impairment, and 7 to 9 indicate marked functional impairment. The scores for the 3 domains are summed into a total score that ranges from 0 (unimpaired) to 30 (highly impaired). A higher score indicates greater impairment. A negative change score indicates improvement.|Baseline to Week 8|Intent-to-treat population consisted of all patients in the Safety Population who had at least 1 post-baseline assessment of the MADRS total score. Only participants with scores for all 3 domains were included in the analysis.|||Units on a scale||Standard Error|Least Squares Mean
2672317|NCT01469377|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 8|The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.|Baseline to Week 8|Intent-to-treat population consisted of all patients in the Safety Population who had at least 1 post-baseline assessment of the MADRS total score.|||Units on a scale||Standard Error|Least Squares Mean
2672318|NCT01469364|Primary|Change in Pulmonary Function, as Measured by Serial Forced Expiratory Flow (FEF25-75) on Spirometry at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1|Within-subject change to absolute FEF 25-75 month 1 vs. 0. FEF 25-75 was measured 14-35 days after the start of months 1|Baseline, month 1||||Liter||Inter-Quartile Range|Median
2672319|NCT01469364|Primary|Change in Pulmonary Function, as Measured by Serial Forced Expiratory Flow (FEF25-75) on Spirometry at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 5.|Within-subject change to absolute FEF 25-75 month 5 vs 0. FEF 25-75 was measured 14-35 days after the start of months 5|Baseline, month 5||||Liter||Inter-Quartile Range|Median
2672320|NCT01469364|Primary|Change in Respiratory-specific Health Related Quality of Life, Measured by Serially Self Administered St. George's Respiratory Questionnaire (SGRQ) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 5.|The SRGQ measures activities, symptoms, and impacts of living with a pulmonary condition. We analyzed the change to the within-subject Total score month 5 vs 0. Total score ranges from 0-100 with a smaller value representing better respiratory-specific QOL. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference in theTotal Score. The SGRQ was completed 14-35 days after the start of month 5 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 5|subjects with completed SF-36 surveys at month 5 and 0 (n=26) time-points.|||units on a scale||Inter-Quartile Range|Median
2672321|NCT01469364|Primary|Change in Respiratory-specific Health Related Quality of Life, Measured by Serially Self Administered St. George's Respiratory Questionnaire (SGRQ) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1|The SRGQ measures activities, symptoms, and impacts of living with a pulmonary condition. We analyzed the change to the within-subject Total score month 1 vs. 0. Total score ranges from 0-100 with a smaller value representing better respiratory-specific QOL. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference in the Total Score. The SGRQ was completed 14-35 days after the start of months 1 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 1|subjects with completed SF-36 surveys at month 1 and month 0 (n=28) time-points.|||units on a scale||Inter-Quartile Range|Median
2672322|NCT01469364|Primary|Change in Global Health Related Quality of Life, Measured by Serially Self-administered Short Form 36 Health Survey Questionnaire (SF-36) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1 and Month 5.|The SF-36 is a commonly used, well validated measure of global health related quality of life. The survey was self-administered. There are 8 subscales which combine to form a Physical Component Score (PCS) and a Mental Component Score (MCS). We analyzed within subject changes to the PCS and MCS at month 5 vs 0. MCS and PCS scores are relative to a US population mean of 50. The higher the score, the better one perceives his quality of life. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference. The SF-36 was completed 14-35 days after the start of months 1 and 5 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 5|subjects with completed SF-36 surveys at month 5 and 0 (n=26) time-points.|||units on a scale||Inter-Quartile Range|Median
2672323|NCT01469364|Primary|Change in Global Health Related Quality of Life, Measured by Serially Self-administered Short Form 36 Health Survey Questionnaire (SF-36) at Baseline (Prior to AZLI First Dose) and During AZLI Therapy at Month 1|The SF-36 is a commonly used, well validated measure of global health related quality of life. The survey was self-administered. There are 8 subscales which combine to form a Physical Component Score (PCS) and a Mental Component Score (MCS). We analyzed within subject changes to the PCS and MCS at month 1 vs. 0. MCS and PCS scores are relative to a US population mean of 50. The higher the score, the better one perceives his quality of life. A change in score of 4 points or more is considered clinically meaningful. Scores represent Median Absolute Difference. The SF-36 was completed 14-35 days after the start of months 1 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 1|subjects with completed SF-36 surveys at month 1 and month 0 (n=28)|||units on a scale||Inter-Quartile Range|Median
2672345|NCT01469182|Secondary|Number of Participants Reporting Throat Irritation|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with throat irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment|||Participants|||Number
2672324|NCT01469364|Secondary|Bronchoalveolar Lavage Fluid (BALF) Neutrophilia After Treatment, When Performed as Part of Clinical Care (SOC).|The study team is measuring the change in neutrophils AFTER treatment. They will compare a SOC BAL taken after AZLI with the BAL taken within 90 days of AZLI initiation (pre or baseline measure). The post AZLI BAL measurement time range is 15 days after first course of AZLI up to last day of the 3rd and final course of AZLI (over a period of 5 consecutive months).|Baseline - defined as a within 90 days of enrollment and After Treatment (5 months)|Participants with paired SOC bronchoalveolar lavage fluid cell differential counts performed within 90 days of AZLI month 1 (baseline timepoint) and >=15 days after AZLI dose 1 through the completion of dose 3 (study month 5) were included in the analysis (n=5).|||mean percentage of neutrophils||Standard Deviation|Mean
2672325|NCT01469364|Secondary|Among Patients Colonized With Pseudomonas Aeruginosa, Change in Infection Burden as Measured by the Culture Final Report (0,1+, 2+, 3+, 4+) of in Pseudomonas Aeruginosa Sputum or Bronchoalveolar Fluid.|Microbiology data was collected when performed for SOC purposes on BAL or sputum samples. Baseline and 1 month value represents the culture final report value (0,1+, 2+, 3+, 4+) of Pseudomonas aeruginosa. A value of zero represents no Pseudomonas aeruginosa sputum or bronchoalveolar fluid. A value of 4 represents high amounts of Pseudomonas aeruginosa sputum or bronchoalveolar fluid.|Baseline, month 1|The statistical analysis was unable to be performed due to insufficient number of paired observations. Only 9 of 30 enrolled had baseline microbiology data, 3 were cultured positive for Pseudomonas Aeruginosa. Only 1 of the 3 had a subsequent SOC BAL sample collected. Therefore, only raw data is entered for the one subject.|||culture value of Pseudomonas aeruginosa|||Number
2672326|NCT01469364|Secondary|Change in HRQOL Off AZLI Therapy.|This will be compared to study month 0 (baseline), when obtained at standard of care visit (SOC)|At study months 2 or 4|Partial data for this outcome measure was collected on 4 participants and due to not having a complete data set the analyzation was not completed.||||||
2672327|NCT01469364|Secondary|Change in FEV1 Off AZLI Therapy|This will be compared to study month 0 (baseline, when obtained as standard of care (SOC).|At Study Months 2 and 4|Partial data for this outcome measure was collected on 4 participants and due to not having complete data set analyzation was not completed.||||||
2672328|NCT01469364|Primary|Change in Pulmonary Function, as Measured by Serial Forced Expiratory Volume in 1 Second (FEV1) on Spirometry|Within-subject change to absolute FEV1 month 5 vs 0.|Baseline, month 5||||Liter||Inter-Quartile Range|Median
2672329|NCT01469364|Primary|Change in Pulmonary Function, as Measured by Serial Forced Expiratory Volume in 1 Second (FEV1) on Spirometry|Within-subject change to absolute FEV1 month 1 vs. 0. FEV1 was measured 14-35 days after the start of months 1 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).|Baseline, month 1||||Liter||Inter-Quartile Range|Median
2672330|NCT01469234|Secondary|Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point|"The individual symptom score for Itchy Mouth/Throat/Ears was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Mouth/Throat/Ears symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."|||units on a scale||Standard Deviation|Mean
2672331|NCT01469234|Secondary|Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point|"The individual symptom score for Nasal Congestion was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Nasal Congestion symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."|||units on a scale||Standard Deviation|Mean
2672332|NCT01469234|Secondary|Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point|"The individual symptom score for Itchy Eyes was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."|||units on a scale||Standard Deviation|Mean
2672333|NCT01469234|Secondary|Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point|"The individual symptom score for Water Eyes was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Watery Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."|||units on a scale||Standard Deviation|Mean
2672334|NCT01469234|Secondary|Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point|"The individual symptom score for Sneezing was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Sneezing symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."|||units on a scale||Standard Deviation|Mean
2672335|NCT01469234|Secondary|Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point|"The individual symptom score for Itchy Nose was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."|||units on a scale||Standard Deviation|Mean
2672336|NCT01469234|Secondary|Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point|"The individual symptom score for Runny Nose was rated on a 5-point~scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Runny Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity."|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."|||units on a scale||Standard Deviation|Mean
2672337|NCT01469234|Primary|Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)|The MSC Score is calculated as the sum of 5 individual symptom scores for Runny Nose, Itchy Nose, Sneezing, Watery Eyes, and Itchy Eyes. Each individual symptom is rated on a 5-point scale of severity: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The total MSC score ranges from 0 - 25. Increasing scores are associated with increasing severity.|From time of sensitization (time 0) to end of visit (~8 hours)|"Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point."|||units on a scale||Standard Deviation|Mean
2672338|NCT01469221|Secondary|2-Year Recurrence Rate|Proportion of patients with recurrence at or before 24 months|24 Months|Patients who were in the Double Blind Phase|||Participants|||Count of Participants
2672339|NCT01469221|Primary|Time to Recurrence|Time from randomization to the date of first histologically confirmed recurrence of bladder cancer|24 Months|Patients who were in the Double Blind Phase|||months||Full Range|Median
2672340|NCT01469182|Secondary|Number of Participants Who Discontinued Due to Treatment-emergent AEs|Participants were treated with either SCH 39641 12 Amb a 1-U or placebo for 28 days, and the number who discontinued due to treatment emergent-AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.|Up to Day 28|ASAT consisting of participants who received at least one dose of study treatment|||Participants|||Number
2672341|NCT01469182|Secondary|Number of Participants Reporting Skin Pruritus|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with skin pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment|||Participants|||Number
2672342|NCT01469182|Secondary|Number of Participants Reporting Nasal Passage Irritation|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with nasal passage irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment|||Participants|||Number
2672343|NCT01469182|Secondary|Number of Participants Reporting Eye Pruritus|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with eye pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment|||Participants|||Number
2672344|NCT01469182|Secondary|Number of Participants Reporting Mouth Oedema|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with mouth oedema were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment|||Participants|||Number
2672491|NCT01468974|Secondary|In-scaffold Peak Systolic Velocity Ratio (PSVR)|In-scaffold Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound|1 month|PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.|||ratio||Standard Deviation|Mean
2672347|NCT01469182|Secondary|Number of Participants Reporting Oral Pruritus.|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with oral pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported.|Up to Day 35|ASAT consisting of participants who received at least one dose of study treatment|||Participants|||Number
2672348|NCT01469182|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs)|Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization.|Up to Day 35|All subjects as treated (ASAT) consisting of participants who received at least one dose of study treatment|||Participants|||Number
2672349|NCT01469065|Secondary|Change From Baseline in Fasting Lipid Parameters at Day 14 and 16|Baseline for fasting triglycerides (TG) was defined as the average of the Day -1 (hour -48), Day 0 (hour -24), and Day 1 pre-dose (hour 0) measurements. Baseline for fasting total cholesterol (TC), cholesterol (high-density lipoprotein (HDL)), and cholesterol (low-density lipoprotein (LDL)) was defined as the Day 1 pre-dose (hour 0) measurement.|Baseline: hour -48 on Day -1, hour -24 on Day 0, and hour 0 on Day 1 for TG and Hour 0 (before morning dose) on Day 1 for TC, HDL, and LDL; 48 hours after morning dose on Day 16 for TG and Hour 0 (before morning dose) on Day14 for TC, HDL, and LDL|"The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest; n is the number of participants analyzed for each day."|||mg/dL||Standard Deviation|Mean
2672350|NCT01469065|Secondary|Change From Baseline in Area Under the Curve of C-peptide From Time 2 to 6 Hours Post Morning Dose (C-peptide AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14|Area Under the Curve of C-peptide from Time 2 to 6 Hours Post Morning Dose (C-peptide AUC(2-6)) was calculated based on 8 C-peptide measurements at prespecified timepoints using the linear trapezoidal method. Nominal times were used in the calculation. Liquid meal was administered 2 hours post morning dose of PF-04991532 for mixed meal tolerance test (MMTT).|Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.|||ng*hr/mL||Standard Deviation|Mean
2672351|NCT01469065|Secondary|Change From Baseline in Area Under the Curve of Insulin From Time 2 to 6 Hours Post Morning Dose (Insulin AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14|Area Under the Curve of Insulin from Time 2 to 6 Hours Post Morning Dose (Insulin AUC(2-6)) was calculated based on 8 insulin measurements at prespecified time points using the linear trapezoidal method. Nominal times were used in the calculation. Liquid meal was administered 2 hours post morning dose of PF-04991532 for mixed meal tolerance test (MMTT).|Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.|||milliUnit*hour/liter (mU*hr/L)||Standard Deviation|Mean
2672352|NCT01469065|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|The average of the Day -1 (hour -48), Day 0 (hour -24) and Day 1 pre-dose (hour 0) measurements was the baseline for fasting plasma glucose (FPG) analyses.|Baseline: hour -48 on Day -1, hour -24 on Day 0, and hour 0 (before morning dose) on Day 1; hour 0 (before morning dose of each day) on Days 1, 2, 3, 6, and 10; and 24 hours after Day 14 morning dose on Day 15|"The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest; n is the number of participants analyzed for each day."|||mg/dL||Standard Deviation|Mean
2672353|NCT01469065|Secondary|Change From Baseline in Area Under the Curve of Glucose From Time 2 to 6 Hours Post Morning Dose (Glucose AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14|Area under the curve of glucose from time 2 to 6 hours post morning dose (Glucose AUC(2-6)) was calculated based on 8 glucose measurements at prespecified time points using the linear trapezoidal method. Nominal times were used in the calculation. Liquid meal was administered 2 hours post morning dose of PF-04991532 for mixed meal tolerance test (MMTT).|Baseline: hours -46, -45.75, -45.5, -45, -44.5, -44, -43, -and -42 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 2.25, 2.5, 3, 3.5, 4, 5, and 6 hours after Day 14 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.|||mg*hr/dL||Standard Deviation|Mean
2672354|NCT01469065|Secondary|Change From Baseline (Day -2) in Mean Daily Glucose at Day 13|Mean daily glucose (MDG) was calculated based on the mean of 8 glucose measurements at pre-specified time points throughout the day.|Baseline: hours -72, -70, -68, -66, -62, -60, -57, and -54 on Day -2 (Day 1 morning dose was hour 0); Day 13: 0 (before morning dose), 2, 4, 6, 10, 12, 15 and 18 hours after Day 13 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.|||mg/dL||Standard Deviation|Mean
2672355|NCT01469065|Secondary|Dose Normalized Maximum Plasma Concentration After Morning Dose Administration (Cmax(AM)(dn)) of PF-04991532|Maximum Observed Plasma Concentration of PF-04991532 after Morning Dose Administration (Cmax(AM)) divided by dose|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."|||ng/mL/mg||Standard Deviation|Geometric Mean
2672492|NCT01468974|Secondary|In-scaffold Peak Systolic Velocity (PSV)|In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound|3 years|PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.|||cm/sec||Standard Deviation|Mean
2672356|NCT01469065|Secondary|Dose Normalized Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24(dn)) of PF-04991532|Area under the curve from time zero to 24 Hours Postdose (AUC24) divided by total daily dose|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10, 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."|||ng*hr/mL/mg||Standard Deviation|Geometric Mean
2672357|NCT01469065|Secondary|Observed Accumulation Ratio of Maximum Observed Plasma Concentration of PF-04991532 After Morning Dose Administration (Rac, Cmax(AM))|Maximum observed plasma concentration of PF-04991532 after morning dose administration (Cmax(AM)) of Day 14 divided by Cmax(AM) of Day 1|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest.|||ratio||Standard Deviation|Geometric Mean
2672358|NCT01469065|Secondary|Observed Accumulation Ratio of Area Under the Curve From Time Zero to 10 Hours Postdose of PF-04991532 (Rac)|Area under the curve from time zero to 10 hours postdose of PF-04991532 (AUC10) of Day 14 divided by AUC10 of Day 1|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest.|||ratio||Standard Deviation|Geometric Mean
2672359|NCT01469065|Secondary|Apparent Oral Clearance (CL/F) of PF-04991532|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Day 1 and Day 14: 0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10 (before evening dose), 10.5, 11, 12, 13, 15, 18 and 24 hours after morning dose|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."|||milliliter/minute (mL/min)||Standard Deviation|Geometric Mean
2672360|NCT01469065|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04991532 After Evening Dose Administration (Tmax(PM))|Time was computed as post morning dose.|10 (before evening dose), 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."|||hour||Full Range|Median
2672361|NCT01469065|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04991532 After Morning Dose Administration (Tmax(AM))||0 (predose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."|||hour||Full Range|Median
2672362|NCT01469065|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-04991532||Day 14|The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest.|||ng/mL||Standard Deviation|Geometric Mean
2672363|NCT01469065|Secondary|Maximum Observed Plasma Concentration of PF-04991532 After Evening Dose Administration (Cmax(PM))||10 (before evening dose), 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."|||ng/mL||Standard Deviation|Geometric Mean
2672364|NCT01469065|Secondary|Maximum Observed Plasma Concentration of PF-04991532 After Morning Dose Administration (Cmax(AM))||0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning||||ng/mL||Standard Deviation|Geometric Mean
2672365|NCT01469065|Secondary|Area Under the Curve From Time Zero to 10 Hours Postdose (AUC10) of PF-04991532|Area under the plasma concentration versus time curve (AUC) from time zero to 10 hours post morning dose.|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, and 10 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."|||ng*hr/mL||Standard Deviation|Geometric Mean
2672366|NCT01469065|Secondary|Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of PF-04991532|Area under the plasma concentration versus time curve (AUC) from time zero to 24 hours post morning dose|0 (before morning dose), 0.5, 1, 2, 3, 4, 6, 10, 10.5, 11, 12, 13, 15, 18, and 24 hours after morning dose on Day 1 and Day 14|"The pharmacokinetic parameter analysis population was defined as all randomized participants treated with PF-04991532 who had at least 1 of the pharmacokinetic parameters of interest; n is the number of participants analyzed for each day."|||nanogram*hour/milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2672367|NCT01469065|Primary|Change From Baseline (Day -1) in Mean Daily Glucose at Day 14|Mean daily glucose (MDG) was calculated based on the mean of 8 glucose measurements at pre-specified time points throughout the day on Day -1 and Day 14.|Baseline: hours -46, -44, -42, -40, -38, -36, -33, -and -30 on Day -1 (Day 1 morning dose was hour 0); Day 14: 2, 4, 6, 8, 10, 12, 15, and 18 hours after Day 14 morning dose|The pharmacodynamic analysis population was defined as all randomized participants who received at least 1 dose of study medication (PF-04991532 or placebo) and had at least 1 of the pharmacodynamic parameters of interest.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
2672368|NCT01469052|Secondary|Plasma Decay Half-Life (t1/2) in Fed State Versus Overnight Fasting|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.|||hr||90% Confidence Interval|Geometric Mean
2672369|NCT01469052|Secondary|Apparent Oral Clearance (CL/F) in Fed State Versus Overnight Fasting|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.|||L/hr||90% Confidence Interval|Geometric Mean
2672370|NCT01469052|Secondary|Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] in Fed State Versus Overnight Fasting|AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-24).|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.|||ng*hr/mL||90% Confidence Interval|Geometric Mean
2672371|NCT01469052|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) in Fed State Versus Overnight Fasting||Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.|||hr||90% Confidence Interval|Mean
2672372|NCT01469052|Secondary|Maximum Observed Plasma Concentration (Cmax) in Fed State Versus Overnight Fasting||Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 29 (Day 1 of Cycle 2) and Day 30 (Day 2 of Cycle 2)|The actual mean values were not reported in the fed and fasted state because the food effect evaluation was conducted across different dose groups and hence it was not appropriate to report overall mean values in different doses as PK parameters change with dose.|||ng/mL||90% Confidence Interval|Geometric Mean
2672373|NCT01469052|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug. ‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.|||hr||Standard Deviation|Mean
2672374|NCT01469052|Secondary|Apparent Oral Clearance (CL/F)|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug. ‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.|||Liter/hr (L/hr)||95% Confidence Interval|Geometric Mean
2672375|NCT01469052|Secondary|Area Under the Curve From Time Zero to 12 Hours [AUC (0-12)]|AUC (0-12)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-12).|Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug. ‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2672376|NCT01469052|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Pre-dose, 0.5, 1, 2, 4, 8, and 12 hrs post-dose on Day 1 and 15 of Cycle 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug. ‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.|||hr||Full Range|Median
2672377|NCT01469052|Secondary|Maximum Observed Plasma Concentration (Cmax)||Pre-dose, 0.5, 1, 2, 4, 8, and 12 hours (hrs) post-dose on Day (D) 1 and 15 of Cycle (C) 1 and Day 29 (Day 1 of Cycle 2); pre-dose on Day 43 (Day 15 of Cycle 2) and Day 57 (Day 1 of Cycle 3)|Analysis population included all enrolled participants who received at least one dose of the study drug.‘n’ signifies those participants evaluated for this measure at specific time point for each cohort respectively.|||Nanogram/milliliter (ng/mL)||Standard Deviation|Geometric Mean
2672378|NCT01469052|Primary|Maximum Tolerated Dose (MTD)|"MTD is defined as the dose level at which no more than 1 of 6 participants experience dose-limiting toxicity (DLT) following de-escalation from the maximum administered dose (MAD). DLT includes grade (Gr) 2 or greater gastrointestinal toxicities, Gr 3 anemia, nonhematological toxicities (excluding nausea, vomiting, and diarrhea) or Gr 4 neutropenia, thrombocytopenia and inability to resume axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity."|Baseline up to Day 28|Analysis population included all enrolled participants who received at least one dose of the study drug.|||mg BID|||Number
2672379|NCT01469039|Secondary|Clinical Global Impression - Improvement (CGI-I) Scores at Day 85|"The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the study. Results indicate participants evaluated at one of the following categories: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse."|85 Days|FAS, defined as all randomized subjects who received at least 1 IM dose of study drug and had at least 1 primary efficacy assessment after administration of IM study drug.|||participants in category|||Number
2672493|NCT01468974|Secondary|In-scaffold Peak Systolic Velocity (PSV)|In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound|2 years|PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.|||cm/sec||Standard Deviation|Mean
2672380|NCT01469039|Primary|The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.|Data collected from baseline to day 85|Full Analysis Set (FAS) defined as all randomized subjects who received at least 1 dose of IM study drug and had at least 1 primary efficacy assessment after administration of IM study drug.|||units on a scale||Standard Error|Least Squares Mean
2672381|NCT01469013|Secondary|PK: Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104||Wks 0, 8, 12, or 20: Predose, 15 to 30 minutes and 1 to 3 hours postdose; Wks 2 or 4 and 15 or 16: Predose; Wks 28, 40, 52, or 64: random single sample.|All participants who received any study drug and had evaluable Cmax data.|||nM||Geometric Coefficient of Variation|Geometric Mean
2672382|NCT01469013|Secondary|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of LY3009104|Steady state is achieved when the rate of drug input is equal to the rate of drug elimination. The AUC(tau,ss) at 1 dosing interval is the average concentration of the drug at steady state multiplied by the time of the dosing interval.|Weeks (Wks) 0, 8, 12, or 20: Predose, 15 to 30 minutes and 1 to 3 hours postdose; Wks 2 or 4 and 15 or 16: Predose; Wks 28, 40, 52, or 64: random single sample.|All participants who received any study drug and had evaluable data for AUC(tau,ss).|||nanomoles*hour (nM*h)||Geometric Coefficient of Variation|Geometric Mean
2672383|NCT01469013|Secondary|Percentage of Participants Who Achieved an SDAI Remission at 64 Weeks (Part B)|"The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, PtGADA, PhGA, and CRP. The equation used to calculate the SDAI:~SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA-VAS / 10 and PhGA-VAS=PhGA-VAS / 10. Definition of remission is SDAI ≤ 3.3. Percentage of participants = (number of responders) / (number of participants treated) * 100"|Baseline up to 64 weeks|All participants who received any amount of study drug in Part B.|||percentage of participants|||Number
2672384|NCT01469013|Secondary|Percentage of Participants Who Achieved an SDAI Remission at 12 Weeks (Part A)|"The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, PtGADA, PhGA and CRP. The equation used to calculate the SDAI:~SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA -VAS/ 10 and PhGA-VAS=PhGA-VAS / 10. Definition of remission is SDAI ≤ 3.3. Percentage of participants = (number of responders) / (number of participants treated) * 100"|Baseline up to 12 weeks|All participants who received any amount of study drug in Part A.|||percentage of participants|||Number
2672385|NCT01469013|Secondary|Percentage of Participants Who Achieved a DAS28 Remission at 64 Weeks (Part B)|DAS modified included the DAS28 that consisted of a composite score of the following variables: TJC28, SJC28, CRP (mg/L), and PtGADA-VAS on a 0 to 100 mm VAS: 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 calculated as: DAS28−CRP = 0.56(sqrt of TJC28)+0.28(sqrt of SJC28)+0.36[ln(CRP +1)]+0.014(VAS)+0.96. For remission, DAS28 is <2.6. Percentage of participants = (number of participants with DAS 28 remission) / (number of participants treated) * 100.|Baseline up to 64 weeks|All participants who received any amount of study drug in Part B.|||percentage of participants|||Number
2672386|NCT01469013|Secondary|Percentage of Participants Who Achieved a DAS28 Remission at 12 Weeks (Part A)|DAS modified included the DAS28 that consisted of a composite score of the following variables: TJC28, SJC28, CRP (mg/L), and PtGADA on a 0 to 100 mm VAS: 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 calculated as: DAS28−CRP = 0.56(square root of TJC28)+0.28(square root of SJC28)+0.36[ln(CRP +1)]+0.014(VAS)+0.96. For remission, DAS28 is <2.6. Percentage of participants = (number of participants with DAS28 remission) / (number of participants treated) * 100.|Baseline up to 12 weeks|All participants who received any amount of study treatment in Part A.|||percentage of participants|||Number
2672387|NCT01469013|Secondary|Mean Value of ACR-N Response (Part B)|"The ACR-N Response Index is a continuous measure of clinical, laboratory, and functional measures in RA to characterize the percentage of improvement from baseline in RA disease activity. This index is defined as the lowest of either: a) percent change in TJC, b) percent change in SJC, or c) median percent change of the remaining 5 ACR core criteria (HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, or PhGA-VAS). A participant with an ACR-N of X has improvement of at least X% in tender and swollen joints and a median improvement of at least X% in the 5 remaining ACR core criteria. Since ACR-N is a continuous measure, the mean values are reported instead of the originally registered percentage of participants."|Baseline up to 64 weeks|All participants who received any study drug in Part B and had baseline and at least one post baseline ACR-N response measure. LOCF was used to impute missing post-baseline values.|||percentage of responders||Standard Deviation|Mean
2672388|NCT01469013|Secondary|Mean Value of ACR-N Response (Part A)|"The ACR-N Response Index is a continuous measure of clinical, laboratory, and functional measures in RA to characterize the percentage of improvement from baseline in RA disease activity. This index is defined as the lowest of either: a) percent change in TJC, b) percent change in SJC, or c) median percent change of the remaining 5 ACR core criteria (HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, or PhGA-VAS). A participant with an ACR-N of X has improvement of at least X% in tender and swollen joints and a median improvement of at least X% in the 5 remaining ACR core criteria. Since ACR-N is a continuous measure, the mean values are reported instead of the originally registered percentage of participants."|Baseline up to 12 weeks|All participants who received any study drug in Part A and had baseline and at least one post baseline ACR-N response measure. LOCF was used to impute missing post-baseline values.|||percentage of responders||Standard Deviation|Mean
2672389|NCT01469013|Secondary|Mean Change in HAQ-DI Responses up to 64 Weeks (Part B)|HAQ-DI was a participant-reported questionnaire that consisted of 24 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the week using response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 domains were required. Otherwise, HAQ-DI score was considered missing. The HAQ-DI score was the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3, 0 being without any difficulty and 3 being unable to do.|Baseline, 64 weeks|All participants who received any amount of study drug in Part B and had HAQ-DI evaluated at analysis time points. The last non-missing post-baseline value in Part B was used.|||units on a scale||Standard Deviation|Mean
2672390|NCT01469013|Secondary|Mean Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) Responses up to 12 Weeks (Part A)|HAQ-DI was a participant-reported questionnaire that consisted of 24 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the week using response categories: without any difficulty (0), with some difficulty (1), with much difficulty (2), and unable to do (3). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 domains were required. Otherwise, HAQ-DI score was considered missing. The HAQ-DI score was the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3, 0 being without any difficulty and 3 being unable to do.|Baseline, 12 weeks|All participants who received any amount of study drug in Part A and had HAQ-DI evaluated at analysis time points. The last non-missing post-baseline value in Part A was used.|||units on a scale||Standard Deviation|Mean
2672391|NCT01469013|Secondary|Mean Change in SDAI Responses up to 64 Weeks (Part B)|"The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, PtGADA, PhGA, and CRP. The equation used to calculate the SDAI:~SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA -VAS/ 10 and PhGA-VAS=PhGA-VAS/ 10, with lower values indicating fewer symptoms."|Baseline, 64 weeks|All participants who received any amount of study drug in Part B and had data for SDAI at analysis time points. The last non-missing post-baseline value in Part B was used.|||units on a scale||Standard Deviation|Mean
2672392|NCT01469013|Secondary|Mean Change in Simplified Disease Activity Index (SDAI) Responses up to 12 Weeks (Part A)|The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, patient and physician global assessment of disease activity and CRP. The equation used to calculate the SDAI:SDAI=SJC28+TJC28+PtGADA-VAS+PhGA-VAS+CRP where PtGADA-VAS=PtGADA-VAS / 10 and PhGA-VAS=PhGA-VAS / 10, with lower values indicating fewer symptoms.|Baseline up to 12 weeks|All participants who received any amount of study drug in Part A and had SDAI data at analysis time points. The last non-missing post-baseline value in Part A was used.|||units on a scale||Standard Deviation|Mean
2672393|NCT01469013|Secondary|Percentage of Participants Who Achieved an EULAR28 Response at 64 Weeks (Part B)|EULAR Responder Index based on 28 joint counts categorizes clinical response based on improvement from baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP <3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or non-responders based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP Responder Index defines a good (absolute: ≤3.2 and >1.2 improvement from baseline), moderate (absolute: >3.2 and ≤5.1 and >0.6 and ≤1.2 improvement from baseline), or no response (absolute: >5.1 and ≤0.6 improvement from baseline). Percentage of participants calculated as = (number of good +moderate responders) / (number of participants treated) * 100.|Baseline up to 64 weeks|All participants who received any amount of study drug in Part B.|||percentage of participants|||Number
2672394|NCT01469013|Secondary|Percentage of Participants Who Achieved an European League Against Rheumatism Rating of 28-Joint Arthritic Condition (EULAR28) Response at 12 Weeks (Part A)|EULAR Responder Index based on 28 joint counts categorizes clinical response based on improvement from baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP ≤3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or non-responders based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: ≤3.2 and >1.2 improvement from baseline), moderate (absolute: >3.2 and ≤5.1 and >0.6 and ≤1.2 improvement from baseline), or no response (absolute: >5.1 and ≤0.6 improvement from baseline). Percentage of participants calculated as = (number of good +moderate responders) / (number of participants treated) * 100.|Baseline up to 12 weeks|All participants who received any amount of study drug in Part A.|||percentage of participants|||Number
2672395|NCT01469013|Secondary|Mean Change From Baseline to Week 64 in DAS Based on the 28 Diarthrodial Joint Count and CRP Level (DAS28-CRP)|DAS modified included the 28 diarthroidal joint count (DAS28) that consisted of a composite score of the following variables: TJC28, SJC28, CRP (mg/L), and PtGADA on a 0 to 100 mm VAS (0mm=no arthritis activity to 100 mm= extremely active arthritis). DAS28 calculated as: DAS28−CRP = 0.56(square root of TJC28)+0.28(square root of SJC28)+0.36[ln(CRP +1)]+0.014(VAS)+0.96. A decrease in DAS28-CRP indicated an improvement in participant's condition.|Baseline, 64 weeks|All randomized participants who received any study drug in Part B and had DAS28-CRP evaluated at analysis time points. The last non-missing post-baseline value in Part B was used.|||units on a scale||Standard Deviation|Mean
2672396|NCT01469013|Secondary|Mean Change From Baseline to Week 12 in Disease Activity Score (DAS) Based on the 28 Diarthrodial Joint Count and CRP Level (DAS28-CRP)|DAS modified included the DAS28 that consisted of a composite score of the following variables: tender joint count out of 28 (TJC28), swollen joint count out of 28 (SJC28), CRP [milligrams per liter (mg/L)], and PtGADA on a 0 to 100 millimeter (mm) VAS (0mm=no arthritis activity to 100 mm= extremely active arthritis). DAS28 calculated as: DAS28−CRP = 0.56(square root of TJC28)+0.28(square root of SJC28)+0.36[ln(CRP +1)]+0.014(VAS)+0.96. A decrease in DAS28-CRP indicated an improvement in participant's condition.|Baseline, 12 weeks|All randomized participants who received any study drug in Part A and had DAS28-CRP evaluated at analysis time points. The last non-missing post-baseline value in Part A was used.|||units on a scale||Standard Deviation|Mean
2672397|NCT01469013|Secondary|Percentage of Participants Who Achieved an ACR70 Response at 64 Weeks (Part B)|ACR70 responders were participants with at least 70% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, or PhGA-VAS. Missing values were imputed using NRI, where non-responders were participants who discontinued the study prior to the completion of Part B. Percentage of participants achieving ACR70 response=(number of ACR70 responders) / (number of participants treated) * 100.|Baseline up to 64 weeks|All participants who received any study drug in Part B.|||percentage of participants|||Number
2672405|NCT01469000|Secondary|Overall Survival (OS)|OS is defined as the time from randomization to the date of death from any cause. Survival time is censored at the date of last contact for participants who are still alive or lost to follow up.|Randomization to Date of Death Due to Any Cause (Up To 67.12 Months)|All participants who received at least 1 dose of study drug. Participants censored: Gefitinib/Pemetrexed =54, Gefitinib=26|||Months||95% Confidence Interval|Median
2672398|NCT01469013|Secondary|Percentage of Participants Who Achieved an ACR70 Response at 12 Weeks (Part A)|ACR70 responders were participants with at least 70% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, or PhGA-VAS. Missing values were imputed using NRI, where non-responders were participants who discontinued the study prior to the completion of Part A. Percentage of participants achieving ACR70 response=(number of ACR70 responders / number of participants treated) * 100.|Baseline up to 12 weeks|All participants who received any study drug in Part A.|||percentage of participants|||Number
2672399|NCT01469013|Secondary|Percentage of Participants Who Achieved an ACR20 Response at 64 Weeks|ACR20 responders are participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI which measured participants perceived degree of difficulty performing daily activities, CRP and ESR, PAAP-VAS, PtGADA-VAS, or PhGA-VAS. Missing values were imputed using NRI, where non-responders were participants who discontinued the study prior to the completion of Part B. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants treated) * 100.|Baseline up to 64 weeks|All participants who received any amount of study drug in Part B.|||percentage of participants|||Number
2672400|NCT01469013|Primary|Percentage of Participants in the 4 mg and 8 mg Dose Groups Who Achieved an American College of Rheumatology 20 (ACR20) Responder Index Response Baseline Through Week 12 .|ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP) and erythrocyte sedimentation rate (ESR), Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS) , Patient's Global Assessment of Disease Activity-VAS (PtGADA-VAS), and Physician's Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI), where non-responders were participants who discontinued the study prior to the completion of Part A. Percentage of participants achieving ACR20 response = (number of ACR20 responders) /(number of participants treated) * 100.|12 weeks|All participants who received at least 1 dose of 4 mg, 8 mg baricitinib (LY3009104) or placebo in Part A as per protocol for combined analysis .|||percentage of participants|||Number
2672401|NCT01469000|Secondary|Time to Worsening of Symptom (TWS) as Per Lung Cancer Symptom Scale (LCSS)|TWS was the elapsed time from the date of randomization to the first date of worsening in any one of the 6 LCSS symptoms. The LCSS (patient and observer) were administered at baseline and at the end of each 21-day cycle, until disease progression, and at short-term follow-up. Content for the patient version ―collected using a visual analog scale (VAS) anchored at 0 and 100, respectively representing the best and worst outcome― included 6 disease-specific measures: (appetite, fatigue, cough, dyspnea, hemoptysis and pain) and 3 summary consequences of lung cancer (overall symptom burden, diminished normal activities, and lowered quality-of-life).The observer version included only the 6 disease-specific measures and the responses were collected using a 5-point ordinal scale that was reverse coded with 0 and 100 respectively representing the worst and best outcome.TWS was censored at the date of the last LCSS assessment for participants who were not known to have LCSS worsening.|Baseline to Progressive Disease (Up To 50 Months )|Participants who received at least 1 dose of study drug & had evaluable events. Censored participants: a:52,32; b:60,32;c:68,43;d:73,39;e:97,43;f:78,45;g:64,38;h:54,37;i: 59,35; j:59,40;k:52,33;l:83,45;m:79,43;n:100,56;o:82,32 for 250 mg Gefitinib/500 mg Pemetrexed and 250 mg Gefitinib arms respectively.|||months||95% Confidence Interval|Median
2672402|NCT01469000|Secondary|Duration of Response (DoR)|DoR was defined as the time from the date of the first CR or PR to the first date of Progressive Disease (PD) ( RECIST 1.1 Criteria) or death from any cause.CR is the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm.Tumor marker results must have normalized. PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Also,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression. Participants not known to have died or to have had progression of disease as of the data-inclusion cut-off date for a particular analysis,duration of tumor response was censored at the date of the participants last tumor assessment prior to that cut-off date.|First Observation of CR or PR to Progressive Disease or Death Due to Any Cause (Up To 57.36 Months)|All randomized participants who received at least 1 dose of drug. Participants censored: Gefitinib/Pemetrexed =30, Gefitinib=7|||Months||95% Confidence Interval|Median
2672403|NCT01469000|Secondary|Percentage of Participants With CR, PR, and Stable Disease (SD) (Disease Control Rate [DCR])|Disease control rate is the percentage of participants with a confirmed CR, PR or SD as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) criteria. CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PR is defined at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|Randomization to Progressive Disease (Up To 57.36 Months)|All participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2672404|NCT01469000|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])|ORR is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. Partial Response (PR) is defined at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.|Randomization to Progressive Disease (Up to 57.36 Months)|All participants who received at least 1 dose of study. Participants censored: Gefitinib/Pemetrexed =17, Gefitinib=3|||percentage of participants|||Number
2672487|NCT01468974|Secondary|In-scaffold Peak Systolic Velocity Ratio (PSVR)|Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound|3 years|PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.|||ratio||Standard Deviation|Mean
2672406|NCT01469000|Secondary|Time To Progressive Disease (TTPD)|TTPD is defined as time from the date of randomization to the first date of disease progression. For each participant who is not known to have had a progression of disease as of the data-inclusion cut-off date for a particular analysis, or who has died without progression of disease, TTPD will be censored for that analysis at the date of the participant's last tumor assessment prior to that cut-off date. TTPD was analyzed twice: (1) excluding clinical progressions of disease (that is,those not defined according to the RECIST version 1.1 criteria ), and (2) including clinical progressions. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. Also, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.|Randomization to Progressive Disease (Up To 58.78 Months)|All participants who received at least 1 dose of study drug. Participants censored: Gefitinib/Pemetrexed =31, Gefitinib=4|||months||95% Confidence Interval|Median
2672407|NCT01469000|Primary|Progression Free Survival (PFS)|PFS is defined as the time from randomization to the first date of objectively determined progressive disease or death from any cause,whichever is earlier.The censoring is taken in the following order: If a participant didn't have a complete baseline disease assessment,then the PFS time was censored at the enrollment date, regardless of whether or not objectively determined disease progression or death has been observed for the participant;otherwise,if a participant is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis,the PFS time will be censored at the last complete objective progression-free disease assessment date.Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study. Also,the sum must also demonstrate an absolute increase of at least 5 millimeter (mm).The appearance of one or more new lesions is also considered progression.|Randomization to Progressive Disease or Death Due to Any Cause (Up to 58.78 Months)|All participants who received at least 1 dose of study drug. Participants censored: Gefitinib/Pemetrexed =24, Gefitinib=3|||Months||95% Confidence Interval|Median
2672408|NCT01468987|Secondary|Rapid Assessment of Physical Activity (RAPA) at 26 Weeks|The RAPA questionnaire assesses the level and intensity of physical activity of adult participants. It contains 2 subscales: RAPA 1 (Aerobic) and RAPA 2 (Strength and Flexibility). RAPA 1 contains 7 questions regarding the participant's amount and intensity of physical activity, allowing each participant's aerobic activity level to be categorized as sedentary, underactive, light activities, light activity, regular underactive, or active. RAPA 2 contains 2 questions regarding participants' physical activities that increase strength and improve flexibility. Each participant's strength and flexibility activity level is then categorized as neither strength nor flexibility activity, either strength or flexibility activity (not both), both strength and flexibility activity. The percentage of participants in each RAPA 1/2 category is presented and was calculated by dividing the number of participants in each RAPA 1/2 category by the total number of participants analyzed, multiplied by 100.|up to 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable RAPA data. Missing endpoints were imputed with the LOCF method, using only post-baseline data.|||percentage of participants|||Number
2672409|NCT01468987|Secondary|EuroQoL-5D (EQ-5D) at 26 Weeks|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale of 1-3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using ANCOVA adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, and baseline number of insulin injections [1, 2, or ≥ 3]), and baseline EQ-5D score.|up to 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable EQ-5D data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2672410|NCT01468987|Secondary|Low Blood Sugar Survey (LBSS) at 26 Weeks|LBSS (also referenced as Hypoglycemia Fear Survey - II [HFS-II]) is a 33-item questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using MMRM including stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline number of insulin injections [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline LBSS score.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable LBSS data at both baseline and post-baseline.|||units on a scale||Standard Error|Least Squares Mean
2672411|NCT01468987|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ) at 26 Weeks|ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, Insulin Delivery Device. Data presented are the transformed overall score on a scale of 0-100, where higher scores indicate better treatment satisfaction. LS means were calculated using an analysis of covariance (ANCOVA) model with treatment and stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, and baseline number of insulin injections [1, 2, or ≥3]) as fixed effects and baseline value of the ITSQ scores as a covariate.|up to 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable ITSQ data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2672412|NCT01468987|Secondary|Number of Participants With Change in Anti-LY2605541 Antibodies From Baseline to 26 Weeks|The number of participants with a treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable, or from detectable to the value with at least 130% relative increase from baseline.|Baseline through 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable anti-LY2605541 antibody data at baseline and post-baseline.|||participants|||Number
2672413|NCT01468987|Secondary|Lipid Profile at 26 Weeks|Concentrations of cholesterol, high-density lipoprotein cholesterol (HDL-C), LDL-C, and triglycerides are summarized. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], except for the LDL-C outcome variable], number of insulin injections at baseline [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable lipid data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2672414|NCT01468987|Secondary|HbA1c at 26 Weeks|HbA1c is a test that measures a participant's average blood glucose level over the past 2 to 3 months. LS means were calculated using MMRM adjusting for stratification factors (country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment, visit-by-treatment interaction, and baseline HbA1c.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
2672415|NCT01468987|Secondary|0300-hour Blood Glucose to FBG Excursion at 26 Weeks|Results of a 0300-hour to pre-morning meal (FBG) excursion are presented (only SMBG profiles with both 0300 hours and the next day pre-morning measurements are included for the calculation of such excursion). LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline excursion.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2672416|NCT01468987|Secondary|Fasting Blood Glucose (FBG) (by SMBG) Intra-participant Variability at 26 Weeks|FBG was measured by self-monitored blood glucose (SMBG). Between-day glucose variability is measured by the standard deviation of FBG. LS means were calculated using MMRM adjusting for the stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline FBG variability.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FBG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2672417|NCT01468987|Secondary|Fasting Serum Glucose (FSG) From Laboratory at 26 Weeks|LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline FSG.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FSG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2672418|NCT01468987|Secondary|Basal, Bolus, and Total Insulin Dose by Weight at 26 Weeks|Basal insulin dose, short-acting bolus insulin dose (each meal and overall), and total insulin dose were calculated based on the dose during the last 7 days prior to the post-treatment visit or last 3 days prior to the randomization visit. LS means were calculated using a constrained Longitudinal Data Analysis (cLDA) model adjusting for indicator variables of each treatment group at each post-baseline visit and stratification variables (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL and ≥100 mg/dL], and baseline number of insulin injections [1, 2, or ≥3]).|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable insulin dose data.|||units/kg/day||Standard Error|Least Squares Mean
2672419|NCT01468987|Secondary|Percentage of Participants With HbA1c <7.0% Without Nocturnal Hypoglycemia at 26 Weeks|Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with HbA1c <7.0% without nocturnal hypoglycemia by the total number of participants analyzed, multiplied by 100.|up to 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with the LOCF method, using only post-baseline data.|||percentage of participants|||Number
2672420|NCT01468987|Secondary|Percentage of Participants With HbA1c <7.0% and ≤6.5% at 26 Weeks|The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.|up to 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.|||percentage of participants|||Number
2672421|NCT01468987|Secondary|Self-Monitored Blood Glucose (SMBG) 9-point Profiles at 26 Weeks|9-point SMBG profiles were obtained over 2 nonconsecutive days within the week prior to Weeks 0, 4, 12, and 26. SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the subsequent morning prior to the morning meal. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline BG values.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2672422|NCT01468987|Secondary|Body Weight Change From Baseline to 26 Weeks|LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), treatment, visit, treatment-by-visit interaction, and baseline body weight as fixed effects, and participant as a random effect.|Baseline, 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable body weight data at both baseline and post-baseline.|||kilograms (kg)||Standard Error|Least Squares Mean
2672488|NCT01468974|Secondary|In-Scaffold Peak Systolic Velocity Ratio (PSVR)|Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound|2 years|PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.|||ratio||Standard Deviation|Mean
2672423|NCT01468987|Secondary|Percentage of Participants With Nocturnal Hypoglycemia Episodes|Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia and/or a BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with nocturnal hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.|Baseline through 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||percentage of participants|||Number
2672424|NCT01468987|Secondary|Nocturnal Hypoglycemia Rates (Adjusted for 30 Days)|Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or a documented BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline nocturnal hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.|Baseline through 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||events/participant/30 days||Standard Error|Mean
2672425|NCT01468987|Secondary|Percentage of Participants With Total Hypoglycemia Episodes|Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.|Baseline through 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||percentage of participants|||Number
2672426|NCT01468987|Secondary|Total Hypoglycemia Rates (Adjusted for 30 Days)|Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 millimoles per liter [mmol/L]). Group mean rates of total hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline total hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.|Baseline through 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||episodes/participant/30 days||Standard Error|Mean
2672427|NCT01468987|Primary|Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks|HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for stratification factors (country, low-density lipoprotein cholesterol [LDL-C, <100 milligrams per deciliter (mg/dL) and ≥100 mg/dL], and number of insulin injections at baseline [1, 2, or ≥3]), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.|Baseline, 26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
2672428|NCT01468974|Secondary|Vascular Quality of Life (VascuQol) Scores Summary|"Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.~The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain."|At 3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672429|NCT01468974|Secondary|Vascular Quality of Life (VascuQol) Scores Summary|"Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.~The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain."|At 2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672430|NCT01468974|Secondary|Vascular Quality of Life (VascuQol) Scores Summary|"Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.~The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain."|At 1 year|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672431|NCT01468974|Secondary|Vascular Quality of Life (VascuQol) Scores Summary|"Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.~The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain."|At 6 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672432|NCT01468974|Secondary|Vascular Quality of Life (VascuQol) Scores Summary|"Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.~The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain."|At 1 month|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672433|NCT01468974|Secondary|Quality of Life Measures: Mental Component Summary (MCS)|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672434|NCT01468974|Secondary|Quality of Life Measures: Mental Component Summary (MCS)|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672435|NCT01468974|Secondary|Quality of Life Measures: Mental Component Summary (MCS)|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672436|NCT01468974|Secondary|Quality of Life Measures: Mental Component Summary (MCS)|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672437|NCT01468974|Secondary|Quality of Life Measures: Physical Component Summary (PCS)|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672438|NCT01468974|Secondary|Quality of Life Measures: Mental Component Summary (MCS)|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672439|NCT01468974|Secondary|Quality of Life Measures: Physical Component Summary (PCS)|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672440|NCT01468974|Secondary|Quality of Life Measures: Physical Component Summary (PCS)|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672441|NCT01468974|Secondary|Quality of Life Measures: Physical Component Summary (PCS)|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672489|NCT01468974|Secondary|In-scaffold Peak Systolic Velocity Ratio (PSVR)|Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound|1 year|PSVR is excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.|||ratio||Standard Deviation|Mean
2672442|NCT01468974|Secondary|Quality of Life Measures: Physical Component Summary (PCS)|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672443|NCT01468974|Secondary|Quality of Life Measures: Mental Health (MH) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672444|NCT01468974|Secondary|Quality of Life Measures: Mental Health (MH) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672445|NCT01468974|Secondary|Quality of Life Measures: Mental Health (MH) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672446|NCT01468974|Secondary|Quality of Life Measures: Mental Health (MH) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672447|NCT01468974|Secondary|Quality of Life Measures: Mental Health (MH) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672448|NCT01468974|Secondary|Quality of Life Measures: Role Emotional (RE) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672449|NCT01468974|Secondary|Quality of Life Measures: Role Emotional (RE) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672450|NCT01468974|Secondary|Quality of Life Measures: Role Emotional (RE) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672451|NCT01468974|Secondary|Quality of Life Measures: Role Emotional (RE) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672452|NCT01468974|Secondary|Quality of Life Measures: Role Emotional (RE) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672453|NCT01468974|Secondary|Quality of Life Measures: Social Functioning (SF) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672454|NCT01468974|Secondary|Quality of Life Measures: Social Functioning (SF) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672455|NCT01468974|Secondary|Quality of Life Measures: Social Functioning (SF) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672456|NCT01468974|Secondary|Quality of Life Measures: Social Functioning (SF) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672457|NCT01468974|Secondary|Quality of Life Measures: Social Functioning (SF) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672458|NCT01468974|Secondary|Quality of Life Measures: Vitality (VT) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672459|NCT01468974|Secondary|Quality of Life Measures: Vitality (VT) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672460|NCT01468974|Secondary|Quality of Life Measures: Vitality (VT) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672461|NCT01468974|Secondary|Quality of Life Measures: Vitality (VT) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672462|NCT01468974|Secondary|Quality of Life Measures: Vitality (VT) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672463|NCT01468974|Secondary|Quality of Life Measures: General Health (GH) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672464|NCT01468974|Secondary|Quality of Life Measures: General Health (GH) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672465|NCT01468974|Secondary|Quality of Life Measures: General Health (GH) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672466|NCT01468974|Secondary|Quality of Life Measures: General Health (GH) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672467|NCT01468974|Secondary|Quality of Life Measures: General Health (GH) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672468|NCT01468974|Secondary|Quality of Life Measures: Bodily Pain (BP) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672469|NCT01468974|Secondary|Quality of Life Measures: Bodily Pain (BP) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672470|NCT01468974|Secondary|Quality of Life Measures: Bodily Pain (BP) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672471|NCT01468974|Secondary|Quality of Life Measures: Bodily Pain (BP) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672472|NCT01468974|Secondary|Quality of Life Measures: Bodily Pain (BP) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672473|NCT01468974|Secondary|Quality of Life Measures: Role Physical (RP) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672474|NCT01468974|Secondary|Quality of Life Measures: Role Physical (RP) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672475|NCT01468974|Secondary|Quality of Life Measures: Role Physical (RP) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672476|NCT01468974|Secondary|Quality of Life Measures: Role Physical (RP) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672477|NCT01468974|Secondary|Quality of Life Measures: Role Physical (RP) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672478|NCT01468974|Secondary|Quality of Life Measures: Physical Functioning (PF) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672479|NCT01468974|Secondary|Quality of Life Measures: Physical Functioning (PF) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672480|NCT01468974|Secondary|Quality of Life Measures: Physical Functioning (PF) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672481|NCT01468974|Secondary|Quality of Life Measures: Physical Functioning (PF) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672482|NCT01468974|Secondary|Quality of Life Measures: Physical Functioning (PF) Summary|"The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|At 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time point.|||score on a scale||Standard Deviation|Mean
2672483|NCT01468974|Secondary|Binary Restenosis (≥50% DS)|"Binary restenosis is defined as the presence of a hemodynamically significant stenosis ≥ 50% as determined by duplex ultrasound or quantitative angiography (QA).~Scaffold Stenosis ≥ 50% by Duplex Ultrasound Only~In-scaffold %DS ≥ 50% by Arteriogram Only"|1 year|ITT Population. The analysis population included subjects who had available follow up data at that time frame.|||percentage of participants|||Number
2672484|NCT01468974|Secondary|Treated Site Late Loss|"Mean in-lesion Late Loss is calculated as: (MLD post-procedure - MLD follow-up).~The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, treated site or treated segment. Minimum Lumen Vessel Diameter (MLD) is visually estimated during angiography by the Investigator; it is measured during qualitative comparative analysis (QCA) by the Angiographic Core Lab."|12 months|The analysis population included subjects who had available follow up data at that time frame.|||Millimeter||Standard Deviation|Mean
2672485|NCT01468974|Secondary|Treated Site Percent Diameter Stenosis (%DS)|"Percent diameter stenosis (%DS) value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QA.~Reference Vessel Diameter (RVD)~Minimum Luminal Diameter(MLD)"|12 months|The number of participants analyzed includes subjects who had available follow up data at that time frame.|||percent diameter stenosis|Target lesions|Standard Deviation|Mean
2672486|NCT01468974|Secondary|Treated Site Percent Diameter Stenosis (%DS)|"Percent diameter stenosis (%DS) value calculated as 100 * (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QA.~Reference Vessel Diameter (RVD)~Minimum Luminal Diameter(MLD)"|post-procedure||||Percent Diameter stenosis||Standard Deviation|Mean
2672494|NCT01468974|Secondary|In-scaffold Peak Systolic Velocity (PSV)|In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound|1 year|PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.|||cm/sec||Standard Deviation|Mean
2672495|NCT01468974|Secondary|In-scaffold Peak Systolic Velocity (PSV)|In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound|6 months|PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.|||cm/sec||Standard Deviation|Mean
2672496|NCT01468974|Secondary|In-scaffold Peak Systolic Velocity (PSV)|In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound|1 month|PSV was excluded from the analysis for subjects who had TLR prior to the duplex ultrasound and duplex ultrasound was not readable.|||cm/sec||Standard Deviation|Mean
2672497|NCT01468974|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).|At 3 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|||score on a scale||Standard Deviation|Mean
2672498|NCT01468974|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).|At 2 years|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|||score on a scale||Standard Deviation|Mean
2672499|NCT01468974|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).|At 1 year|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|||score on a scale||Standard Deviation|Mean
2672500|NCT01468974|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).|At 6 months|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|||score on a scale||Standard Deviation|Mean
2672501|NCT01468974|Secondary|Walking Impairment Questionnaire (WIQ) Scores|"Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication.~The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best)."|At 1 month|ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|||score on a scale||Standard Deviation|Mean
2672502|NCT01468974|Secondary|Ankle Brachial Index (ABI) for the Treated Limb|"The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.~An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.~Calculation of the Ankle Brachial Index:~(Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)"|At 3 years|ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis.|||ratio||Standard Deviation|Mean
2672503|NCT01468974|Secondary|Ankle Brachial Index (ABI) for the Treated Limb|"The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.~An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.~Calculation of the Ankle Brachial Index:~(Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)"|At 2 years|ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis.|||ratio||Standard Deviation|Mean
2672504|NCT01468974|Secondary|Ankle Brachial Index (ABI) for the Treated Limb|"The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.~An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.~Calculation of the Ankle Brachial Index:~(Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)"|At 1 year|ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis.|||ratio||Standard Deviation|Mean
2672505|NCT01468974|Secondary|Ankle Brachial Index (ABI) for the Treated Limb|"The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.~An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.~Calculation of the Ankle Brachial Index:~(Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)"|At 6 months|ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis.|||ratio||Standard Deviation|Mean
2672506|NCT01468974|Secondary|Ankle Brachial Index (ABI) for the Treated Limb|"The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.~An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.~Calculation of the Ankle Brachial Index:~(Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)"|At 1 month|ITT population. Subjects with ABI values greater than 1.3 will be excluded from the analysis.|||ratio||Standard Deviation|Mean
2672507|NCT01468974|Secondary|Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672508|NCT01468974|Secondary|Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672509|NCT01468974|Secondary|Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672510|NCT01468974|Secondary|Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|6 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672511|NCT01468974|Secondary|Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|1 month|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672636|NCT01468012|Primary|Cocaine Urine Toxicology|Abstinence will be assessed by urine toxicology results collected 3x/week during the 24 week trial or for the length of participation|collected 3x/week for 24 weeks of trial or for the duration of the participants involvement in the study.|Urine toxicology results were not collected||||||
2672512|NCT01468974|Secondary|Number of Participants With Primary Patency|At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672513|NCT01468974|Secondary|Number of Participants With Primary Patency|At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672514|NCT01468974|Secondary|Number of Participants With Primary Patency|At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672515|NCT01468974|Secondary|Number of Participants With Primary Patency|At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.|6 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672516|NCT01468974|Secondary|Number of Participants With Primary Patency|At the designated follow-up, intervention-free patency (< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.|1 month|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2672517|NCT01468974|Secondary|Number of Participants With Ipsilateral Extremity Revascularization (IER)|"Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to target lesion or extremity revised to ipsilateral lesion or extremity.~Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself."|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672518|NCT01468974|Secondary|Number of Participants With Ipsilateral Extremity Revascularization (IER)|"Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to target lesion or extremity revised to ipsilateral lesion or extremity.~Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself."|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672519|NCT01468974|Secondary|Number of Participants With Ipsilateral Extremity Revascularization (IER)|"Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to target lesion or extremity revised to ipsilateral lesion or extremity.~Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself."|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672520|NCT01468974|Secondary|Number of Participants With Ipsilateral Extremity Revascularization (IER)|"Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to target lesion or extremity revised to ipsilateral lesion or extremity.~Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself."|6 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672530|NCT01468974|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.|6 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672521|NCT01468974|Secondary|Number of Participants With Ipsilateral Extremity Revascularization (IER)|"Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to target lesion or extremity revised to ipsilateral lesion or extremity.~Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself."|1 month|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2672522|NCT01468974|Secondary|Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)|A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672523|NCT01468974|Secondary|Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)|A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672524|NCT01468974|Secondary|Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)|A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672525|NCT01468974|Secondary|Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)|A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.|6 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672526|NCT01468974|Secondary|Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)|A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.|1 month|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2672527|NCT01468974|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672528|NCT01468974|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672529|NCT01468974|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672531|NCT01468974|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.|1 month|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2672532|NCT01468974|Secondary|Number of Participants With Scaffold Occlusion|Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure.|0 to 3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672533|NCT01468974|Secondary|Number of Participants With Scaffold Occlusion|Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure.|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672534|NCT01468974|Secondary|Number of Participants With Scaffold Occlusion|Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure.|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672535|NCT01468974|Secondary|Number of Participants With Scaffold Occlusion|Scaffold Thrombosis is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs within 30 days post- index procedure.|6 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672536|NCT01468974|Secondary|Scaffold Occlusion|Number of participants with Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs > 30 days post-index procedure.|1 month|ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2672537|NCT01468974|Secondary|Number of Participants With Scaffold Thrombosis|Scaffold Thrombosis is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs within 30 days post- index procedure.|0 to 1 month|ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2672538|NCT01468974|Secondary|Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity|"Amputation:~The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.~A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations."|0 to 1095 days|ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2672539|NCT01468974|Secondary|Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity|"Amputation:~The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.~A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations."|0 to 730 days|ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2672540|NCT01468974|Secondary|Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity|"Amputation:~The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.~A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations."|0 to 365 days|ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2672541|NCT01468974|Secondary|Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity|"Amputation:~The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.~A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations."|0 to 180 days|ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2672542|NCT01468974|Secondary|Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity|"Amputation:~The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.~A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations."|0 to 30 days|ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2672633|NCT01468077|Secondary|Percentage of Participants Discontinuing Tocilizumab in Response to an AE or a Serious Adverse Event (SAE)|All occurrences of participants who received at least 1 infusion of tocilizumab and then stopped tocilizumab infusions due to an AE or SAE were analyzed.|Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, and 24|SAS Population|||Percentage of Participants|||Number
2672543|NCT01468974|Secondary|Number of Participants With Any Amputation of Treated Limb (Minor and Major)|"The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.~A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations."|3 years|ITT population. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672544|NCT01468974|Secondary|Number of Participants With Any Amputation of Treated Limb (Minor and Major)|"The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.~A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations."|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672545|NCT01468974|Secondary|Number of Participants With Any Amputation of Treated Limb (Minor and Major)|"The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.~A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations."|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672546|NCT01468974|Secondary|Number of Participants With Any Amputation of Treated Limb (Minor and Major)|"The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.~A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations."|6 months|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672547|NCT01468974|Secondary|Number of Participants With Any Amputation of Treated Limb (Minor and Major)|"The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.~A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations."|1 month|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2672548|NCT01468974|Secondary|Number of Participants With Death|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~-Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|3 years|ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672549|NCT01468974|Secondary|Number of Participants With Death|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~-Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|2 years|ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672550|NCT01468974|Secondary|Number of Participants With Death|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~-Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|1 year|ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672551|NCT01468974|Secondary|Number of Participants With Death|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~-Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|6 months|ITT population. Per-subject basis analysis. The number of participants analyzed includes subjects who had available follow up data at that time frame. The analysis population excluded subjects who had lost-to-follow up at that time frame.|||Participants|||Count of Participants
2672634|NCT01468077|Primary|Percentage of Participants With Any Infusion Reaction|An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion and deemed possibly or probably related to tocilizumab.|Baseline (Day 1), and Weeks 4, 8, 12, 16, and 20|Safety Analysis Set (SAS) Population: All randomized participants who received at least one infusion of tocilizumab.|||Percentage of Participants|||Number
2672552|NCT01468974|Secondary|Number of Participants With Death|"Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.)~-Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|1 month|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2672553|NCT01468974|Primary|Clinical Success|"Defined on a per subject basis, as the attainment of a final residual stenosis of < 30% using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications* within 2 days after the index procedure or at hospital discharge, whichever is sooner. (Note that in the ESPRIT I study, only a single target lesion per subject is permitted to be treated).~*Includes the following: Death; Amputation; Scaffold Thrombosis; Target Lesion Revascularization (by any percutaneous or surgical means); Target Vessel Revascularization (by any percutaneous or surgical means)."|> or = 2 days after the index procedure|ITT population.|||percentage of participants|||Number
2672554|NCT01468974|Primary|Technical Success|Technical success is defined on a per lesion basis, the attainment of a final residual stenosis of < 30% at the intended target lesion(s). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as technical success only if the above criteria are met.|On Day 0 (From start of index procedure to end of index procedure)|ITT population.|||percentage of target lesions|||Number
2672555|NCT01468974|Primary|Device Success|Study device success is defined on a per device basis, the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter.|On Day 0 (From start of index procedure to end of index procedure)|Intent-to-treat (ITT) population.|||percentage of devices|||Number
2672556|NCT01468909|Other Pre-specified|Single-nucleotide Polymorphisms, Assessed Using the iPLEX Assay on the Sequenome MassARRAY Platform|Analyzed using deoxyribonucleic acid isolated from whole blood specimens.|Up to 5 years|||||||
2672557|NCT01468909|Secondary|Overall Survival (OS)|Overall survival|Every cycle while patient is receiving protocol therapy. Patients monitored for survival after off therapy every 3 months for 2 years, then every 6 months, up to 5 years|All randomized patients.|||months||90% Confidence Interval|Median
2672558|NCT01468909|Secondary|Percentage of Participants With Tumor Response by CA-125|Response as evaluated by CA-125 levels. Response is indicated if CA-125 reduced by 50% of the baseline measure.|Prior to each cycle of treatment. Then follow-up every three months for 2 years and then every 6 months for 3 years, up to 5 years.|CA-125 Evaluable patients|||percentage of participants||95% Confidence Interval|Number
2672559|NCT01468909|Secondary|Proportion of Participants With Tumor Response by RECIST|Patients with Complete and Partial Tumor Response by RECIST 1.1. Responses (CR and PR) require confirmation at greater than or equal to 4 weeks from initial documentation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Every other cycle for 6 months, then every 3 months until disease progression,Up to 5 years|All randomized patients.|||proportion of participants||95% Confidence Interval|Number
2672560|NCT01468909|Secondary|Adverse Events as Assessed by CTCAE v.4|All grade 3 or greater Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.|From baseline to 30 days after last dose of drug.|Treated and eligible patients|||participants||95% Confidence Interval|Number
2672561|NCT01468909|Primary|Progression Free Survival|The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, Up to 5 years|All randomized patients|||months||95% Confidence Interval|Median
2672562|NCT01468896|Secondary|Time to Disease Progression (Phase II)|The Kaplan-Meier method will be used to estimate time to progression distributions.|From date of registration to date of progression, assessed up to 1 year||||months||95% Confidence Interval|Median
2672563|NCT01468896|Secondary|Proportion of Patients Who Are Progression-free (Phase I)|Summarized by simple descriptive summary statistics. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 months||||proportion of patients|||Number
2672564|NCT01468896|Secondary|Overall Survival (Phase II)|The Kaplan-Meier method will be used to estimate overall survival distribution.|From the date of registration to date of death, assessed up to 1 year||||months||95% Confidence Interval|Median
2672565|NCT01468896|Secondary|Number of Confirmed Clinical Responses (Phase I)|Summarized by simple descriptive summary statistics. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 6 months||||Participants|||Count of Participants
2672566|NCT01468896|Secondary|Induction of Systemic Plasma Levels of Interferon-gamma|Explores graphically how changes in this marker differ between those with versus without an objective response to therapy as well as other potential factors.|Baseline up to day 50|Unable to compare the plasma levels of interferon-gamma between those with versus without an objective response to therapy due to no objective response seen for Phase I or Phase II patients.||||||
2672635|NCT01468012|Primary|Retention in Treatment|The number of participants who completed the 12-week medication phase of the study.|12 weeks||||participants|||Number
2672567|NCT01468896|Primary|Proportion of Patients Who Have Any Response to Treatment (Complete Response or Partial Response), Determined According to Response Evaluation Criteria in Solid Tumors (Phase II)|The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 6 months||||proportion of patients|||Number
2672568|NCT01468896|Primary|Number of Dose-limiting Toxicity Incidents to Determine the Maximum Tolerated Dose of IL-12, Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Phase I)||14 days||||Dose limiting toxicities|||Number
2672569|NCT01468818|Secondary|Level of Persistence of the Transferred Cells in Blood|Determine level of transferred cells in the blood following a non-myeloablative lymphodepleting chemotherapy preparative regimen.|Once week and one month after transfer|No data was collected or analyzed, thus we did not perform an evaluation of persistence for this trial. The reason is that we did not accrue a sufficient number of patients in a timely manner. A minimum of 35 subjects was needed to perform an analysis.||||||
2672570|NCT01468818|Primary|Objective Response in Patients With Metastatic Melanoma|Response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.|Approximately 2 Years||||participants|||Number
2672571|NCT01468675|Primary|Number of Subjects Who Discussed Disease Risk With Primary Care Provider||3 months following primary care visit|1673+1847 (Total=3520) is the total number of subjects who answered the question that this outcome is derived from. (During your last doctor visit, did you talk to your PCP about your risk of developing cancer, heart disease or diabetes.) The total number of subjects included in the analysis is 3703.|||Participants|||Count of Participants
2672572|NCT01468584|Primary|Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up||||percentage of subjects achieving SVR||95% Confidence Interval|Number
2672573|NCT01468558|Primary|AUC(0-48) of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration|The AUC(0-48) is the area under the plot of plasma concentration of drug against time after drug administration. Dihydroergotamine AUC(0-48) is reported in picograms times hour per milliliter (pg*h/ml).|48 hours|Patients with available data at specified time points are included in the analysis population.|||pg*h/ml||Standard Deviation|Geometric Mean
2672574|NCT01468558|Primary|Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration|The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Dihydroergotamine is reported in picograms per milliliter (pg/ml).|48 hours|Patients with available data at specified time points are included in the analysis population.|||pg/ml||Standard Deviation|Geometric Mean
2672575|NCT01468350|Secondary|Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function|"Hand strength as measured by a composite Z-score derived from the grip test, and key, tip and palmar pinch tests~Manual dexterity as measured by the Box and Block Test~Walking speed as measured by the Timed 25 Foot Walk (T25FW)~Gait as measured by gait analysis equipment (to be performed by sites that have the capability to perform it)~For Part B only, subjective impressions of treatment as measured by:~Subject Global Impression (SGI)~Clinician Global Impression (CGI)"|up to 31 days|||||||
2672576|NCT01468350|Primary|Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP)|"Safety and tolerability will be assessed primarily by monitoring Treatment Emergent Adverse Events (TEAEs)~TEAEs are defined as Adverse Events (AEs) with date of onset (or worsening) on or after the start-date of double-blind treatment and no more than 5 days after the last dose of double-blind treatment for Part A of the study and no more than 9 days for Part B of the study.~The severity categories of mild, moderate or severe, are defined below:~Mild is defined as causing no limitation of usual activities~Moderate is defined as causing some limitation of usual activities~Severe is defined as causing inability to carry out usual activities"|up to 31 days|Safety Population (Took at least one dose)|||participants|||Number
2672577|NCT01468337|Secondary|Changes in Mean Macular Sensitivity as Assessed by Microperimetry at Week 48 Compared to Baseline||Baseline and Week 48|||||||
2672578|NCT01468337|Secondary|Changes in the Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) Imaging at Week 48 Compared to Baseline||Baseline and Week 48|||||||
2672579|NCT01468337|Secondary|Changes in Leakage as Observed on Fluorescein Angiography (FA) at Week 48 Compared to Baseline||Baseline and Week 48|||||||
2672580|NCT01468337|Secondary|Changes in Central Retinal Thickness as Measured on Optical Coherence Tomography (OCT) at Week 48 Compared to Baseline||Baseline and Week 48|||||||
2672581|NCT01468337|Secondary|Changes in the Maximum Subretinal Fluid Volume as Measured on Optical Coherence Tomography (OCT) at Week 48 Compared to Baseline||Baseline and Week 48|||||||
2672582|NCT01468337|Secondary|Changes in Mean Macular Sensitivity as Assessed by Microperimetry at Week 2 Compared to Baseline||Baseline and Week 2|||||||
2672583|NCT01468337|Secondary|Changes in the Autofluorescence Patterns as Observed on Fundus Autofluorescence (FAF) Imaging at Week 2 Compared to Baseline||Baseline and Week 2|||||||
2672584|NCT01468337|Secondary|Changes in Leakage as Observed on Fluorescein Angiography (FA) at Week 2 Compared to Baseline||Baseline and Week 2|||||||
2672585|NCT01468337|Secondary|Changes in Central Retinal Thickness as Measured on Optical Coherence Tomography (OCT) at Week 2 Compared to Baseline||Baseline and Week 2|||||||
2672586|NCT01468337|Secondary|Changes in the Maximum Subretinal Fluid Volume as Measured on Optical Coherence Tomography (OCT) at Week 2 Compared to Baseline||Baseline and Week 2|||||||
2672587|NCT01468337|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week 48 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Baseline and Week 48||||ETDRS letters|Participants|Full Range|Mean
2672588|NCT01468337|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 48 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Baseline and Week 48||||ETDRS letters|Participants|Full Range|Mean
2672589|NCT01468337|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week 2 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Baseline and Week 2||||ETDRS letters|Participants|Full Range|Mean
2672590|NCT01468337|Secondary|Changes in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 2 Compared to Baseline|"Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.~A positive change value indicates improvement of the outcome. A negative change value indicates worsening of the outcome."|Baseline and Week 2||||ETDRS letters|Participants|Full Range|Mean
2672591|NCT01468337|Primary|Number of Participants Who Withdrew From the Study||Week 48||||participants|||Number
2672592|NCT01468337|Primary|Total Number of Non-ocular Adverse Events Related to the Investigational Product||Week 48||||Adverse Events|||Number
2672593|NCT01468337|Primary|Total Number of Severe Non-ocular Adverse Events Related to the Investigational Product||Week 48||||Adverse Events|||Number
2672594|NCT01468337|Primary|Total Number of Ocular Adverse Events Related to Investigational Product||Week 48||||Adverse Events|||Number
2672595|NCT01468337|Primary|Total Number of Severe Ocular Adverse Events Related to the Investigational Product||Week 48||||Adverse Events|||Number
2672596|NCT01468311|Secondary|Overall Survival|Overall survival is defined as the time from the date of registration to the date of death due to any cause or if no death occurs to the last documented information on the patient.|OS is evaluated at day 100 post autologous stem cell transplant, then 1-4 times yearly for 5 years||||months||Full Range|Median
2672597|NCT01468311|Secondary|Disease Free Survival (DFS)|DFS is defined as the amount of time participants remain disease free.|DFS is evaluated at day 100 post autologous stem cell transplant, then 1-4 times yearly for 5 years||||months||Full Range|Median
2672598|NCT01468311|Secondary|Complete Response Rate|Complete response rate is defined as the time it takes a participant to achieve a complete response. Response is assessed by the Revised Response Criteria for Malignant Lymphoma. Complete response requires all of the following: complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy. A post treatment residual mass is permitted as long as it is positron emission tomography (PET) negative. If a pretreatment PET scan was negative, all lymph nodes and nodal masses must have regressed on computed tomography (CT) to normal size (<1.5 cm in their greatest transverse diameter for nodes >1.5 cm before therapy); Previously involved nodes that were 1.1 to 1.5 cm in their long axis and more than 1.0 cm in their short axis before treatment must have decreased to <1.0 cm in their short axis after treatment.|20 months post autologous stem cell transplant||||months||Full Range|Median
2672599|NCT01468311|Secondary|Overall Response Rate|Overall response rate is defined as the number of complete and partial responses in patients with refractory or relapsed Hodgkin's disease. Response is assessed by the Revised Response Criteria for Malignant Lymphoma. Complete response requires all of the following: complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy. A post treatment residual mass is permitted as long as it is positron emission tomography negative. Partial response requires all of the following: at least a 50% reduction in the sum of the product of the diameters of up to 6 of the largest dominant nodes or nodal masses. These nodes or masses should be selected according to all of the following: they should be clearly measurable in at least two perpendicular dimensions; if possible they should be from disparate regions of the body; and they should include mediastinal and retroperitoneal areas of disease whenever these sites are involved.|Response is evaluated at day 100 post autologous stem cell transplant, then 1-4 times yearly for 5 years||||Participants|||Count of Participants
2672600|NCT01468311|Primary|Number of Participants With A Dose Limiting Toxicity|Patients who develop either a Common Terminology Criteria in Adverse Events (CTCAE) v4.0 grade 3 or greater non-hematologic toxicity, with the exception of fatigue, of more than 5 days duration possibly, probably or definitely related to the infusion of 90Y-daclizumab prior to the start of Carmustine, Etoposide, Cytarabine, [Ara-C, Cytosine Arabinoside] and Melphalan (BEAM) chemotherapy (Day - 6) will have developed by definition a dose-limiting toxicity (DLT).|30 months||||Participants|||Count of Participants
2672601|NCT01468311|Primary|Number of Participants With Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|30 months||||Participants|||Count of Participants
2672602|NCT01468311|Primary|Maximum Tolerated Dose (MTD) of 90Y-daclizumab With Carmustine, Etoposide, Cytarabine, [Ara-C, Cytosine Arabinoside] and Melphalan (BEAM) and Auto Stem Cell Transplant (ASCT): Phase I Portion|The MTD is defined as the dose level below the dose at which 2 out of 2 to 6 patients at a given dose level develop dose limiting toxicity (DLT). A DLT is defined as patients who develop either a Common Terminology Criteria in Adverse Events (CTCAE) v4.0 grade 3 or greater non-hematologic toxicity, with the exception of fatigue, of more than 5 days duration possibly, probably or definitely related to the infusion of 90Y-daclizumab prior to the start of BEAM chemotherapy (Day - 6) will have developed by definition a dose-limiting toxicity (DLT).|Day 100 post autologous stem cell transplant|MTD was not determined due to low enrollment into the study.||||||
2672603|NCT01468233|Secondary|Change From Baseline to Week 12 in Modified Sartorius Score|The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; no-6 points). The total Sartorius score is the sum of the 12 regional scores. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit within the particular period for efficacy measures was carried forward to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.|Baseline (Week 0) and Week 12|Participants in the ITT population|||units on a scale||Standard Error|Least Squares Mean
2672604|NCT01468233|Secondary|Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) - At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3|"The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) - at worst at Week 12 among participants with Baseline NRS ≥ 3 is presented. Weekly averages of daily assessments were analyzed. NRI: Participants with missing data were considered non-responders."|Baseline (Week 0) up to Week 12|Participants in the ITT population with baseline NRS at Worst ≥ 3|||percentage of participants|||Number
2672605|NCT01468233|Secondary|Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12|The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12 among participants with Hurley Stage II at Baseline. NRI: Participants with missing data were considered nonresponders.|Baseline (Week 0) up to Week 12|Participants in the ITT population with baseline Hurley Stage II|||percentage of participants|||Number
2672606|NCT01468233|Primary|Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12|HiSCR was defined as at least a 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count at Week 12 relative to Baseline. Data are presented for all participants and by baseline Hurley Stage (Stage 1: Abscess formation, single or multiple, without sinus tracts and scarring; Stage II: One or more widely separated recurrent abscesses with tract formation and scars. A participant with at least 1 anatomic region with Hurley Stage II disease and with no anatomic regions with Hurley Stage III disease was classified as Hurley Stage II; and Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. A participant with at least 1 anatomic region with Hurley Stage III disease was classified as Hurley Stage III). Non-responder imputation (NRI): Participants with missing data were considered non-responders.|Baseline (Week 0) up to Week 12|The intention-to-treat (ITT) population, defined as all participants who were randomized at Baseline (Week 0), was analyzed overall and by baseline Hurley Stage|||percentage of participants|||Number
2672607|NCT01468207|Secondary|Change From Baseline to Week 12 in Modified Sartorius Score|The Sartorius Scale is used to quantify the severity of HS. Points are awarded for 12 body areas (left and right axillae, left and right sub/inframammary areas, intermammary area, left and right buttocks, left and right inguino-crural folds, perianal area, perineal area, and other): points were awarded for nodules (2 points for each); abscesses (4 points); fistulas (4 points); scars (1 point); other findings (1 point); and longest distance between two lesions (2-6 points, 0 if no lesions); and if lesions are separated by normal skin (yes-0 points; No-6 points). The total Sartorius score is the sum of the 12 regional scores. Last Observation Carried Forward (LOCF): The last completed evaluation from the previous visit within the particular period for efficacy measures was carried forward to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward.|Baseline (Week 0) and Week 12|Participants in the ITT population|||units on a scale||Standard Error|Least Squares Mean
2672608|NCT01468207|Secondary|Percentage of Participants Achieving At Least 30% Reduction and At Least 1 Unit Reduction From Baseline in Patient's Global Assessment of Skin Pain (NRS30) - At Worst at Week 12 Among Participants With Baseline Skin Pain NRS ≥ 3|"The Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain and the average skin pain due to HS. Ratings for the 2 items range from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The assessments were completed on a daily diary by participants before they went to bed and responded to the items based on a recall period of the last 24 hours. The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the Patient's Global Assessment of Skin Pain (NRS30) - at worst at Week 12 among participants with Baseline NRS ≥ 3 are presented. Weekly averages of daily assessments were analyzed. NRI: Participants with missing data were considered non-responders."|Baseline (Week 0) up to Week 12|Participants in the ITT population with baseline NRS at Worst ≥ 3|||percentage of participants|||Number
2672609|NCT01468207|Secondary|Percentage of Participants With Baseline Hurley Stage II Who Achieved Abscess and Inflammatory Nodule (AN) Count of 0, 1, or 2 at Week 12|The percentage of participants with AN counts lowered to 0, 1, or 2 at Week 12 among participants with Hurley Stage II at Baseline. NRI: Participants with missing data were considered non-responders.|Baseline (Week 0) up to Week 12|Participants in the ITT population with baseline Hurley Stage II|||percentage of participants|||Number
2672610|NCT01468207|Primary|Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12|HiSCR was defined as at least a 50% reduction in abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count at Week 12 relative to Baseline. Data are presented for all participants and by baseline Hurley Stage (Stage 1: Abscess formation, single or multiple, without sinus tracts and scarring; Stage II: One or more widely separated recurrent abscesses with tract formation and scars. A participant with at least 1 anatomic region with Hurley Stage II disease and with no anatomic regions with Hurley Stage III disease was classified as Hurley Stage II; and Stage III: Multiple interconnected tracts and abscesses across the entire area, with diffuse or near diffuse involvement. A participant with at least 1 anatomic region with Hurley Stage III disease was classified as Hurley Stage III). Non-responder imputation (NRI): Participants with missing data were considered non-responders.|Baseline (Week 0) up to Week 12|The intention-to-treat (ITT) population, defined as all participants who were randomized at Baseline (Week 0), was analyzed overall and by baseline Hurley Stage|||percentage of participants|||Number
2672611|NCT01468181|Secondary|Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)|The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S).|Baseline, up to 26 weeks and up to 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable HOMA2 data. LOCF was used to impute missing postbaseline values.|||percentage of HOMA2||Standard Error|Mean
2672612|NCT01468181|Secondary|Change From Baseline in Body Weight||Baseline, up to 26 weeks and up to 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable body weight data. LOCF was used to impute missing postbaseline values.|||kilograms (kg)||Standard Error|Mean
2672613|NCT01468181|Secondary|Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)|Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal. For the mean of all 7-point blood glucose values, the daily mean was calculated as the average of 7 blood glucose values collected on a particular day. The mean of all 7-point blood glucose values at each visit was calculated as the average of 2 daily means. The change from baseline was calculated as the mean of all 7-point blood glucose values at endpoint minus the mean of all 7-point blood glucose values at baseline.|Baseline, up to 26 weeks and up to 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable SMBG data. LOCF was used to impute missing postbaseline. values.|||mg/dL||Standard Error|Mean
2672614|NCT01468181|Secondary|Change From Baseline in Fasting Blood Glucose (FBG)||Baseline, up to 26 weeks and up to 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable FBG data. LOCF was used to impute missing postbaseline values.|||milligrams/deciliters (mg/dL)||Standard Error|Mean
2672615|NCT01468181|Secondary|Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%||26 weeks and 52 weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable HbA1c data. LOCF was used to impute missing postbaseline values.|||percentage of participants|||Number
2672616|NCT01468181|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)||Baseline, up to 26 Weeks and up to 52 Weeks|Participants who were randomized and received at least 1 dose of study drug with evaluable HbA1c data. Last observation carried forward (LOCF) was used to impute missing postbaseline values.|||percentage of HbA1c||Standard Error|Mean
2672617|NCT01468181|Primary|Percentage of Participants With Hypoglycemic Episodes|The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least 1 hypoglycemic episode over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline through 52 Weeks|All enrolled participants who received at least 1 dose of study drug|||percentage of participants|||Number
2672618|NCT01468181|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)|A TEAE was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline through 52 Weeks|All enrolled participants who received at least 1 dose of study drug|||percentage of participants|||Number
2672619|NCT01468077|Secondary|Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits|M-HAQ is a self-reported, valid assessment of functional disability in RA. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Scores range 0 to 3; without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3.|Weeks 4, 8. 12, 20, and 24|ITT Completers|||Percentage of Participants|||Number
2672620|NCT01468077|Secondary|Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits|M-HAQ is a self-reported, valid assessment of functional disability in RA. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Scores range 0 to 3; without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3.|Baseline, Weeks 4, 8, 12, 20, and 24|ITT Completers|||scores on a scale||Standard Deviation|Mean
2672621|NCT01468077|Secondary|High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits|hsCRP is a marker for inflammation and is measured in milligrams per liter (mg/L). High levels of this protein indicate inflammation in diseases such as RA.|Screening, Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Completers|||mg/L||Standard Deviation|Mean
2672622|NCT01468077|Secondary|Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits|ACR90 response is defined as an improvement of ≥90% in SJC (66 joints) and TJC (68 joints) as well as ≥90% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and 24|ITT Completers|||Percentage of Participants|||Number
2672623|NCT01468077|Secondary|Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits|ACR70 response is defined as an improvement of ≥70% in SJC (66 joints) and TJC (68 joints) as well as ≥70% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks 4, 8, 12, 16, 20 and 24|ITT Completers|||Percentage of Participants|||Number
2672624|NCT01468077|Secondary|Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits|ACR50 response is defined as an improvement of ≥50% in SJC (66 joints) and TJC (68 joints) as well as ≥50% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).|Weeks, 4, 8, 12, 16, 20, and 24|ITT Completers|||Percentage of Participants|||Number
2672625|NCT01468077|Secondary|Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits|ACR20 response is defined as an improvement of ≥20% in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) as well as ≥20% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and acute phase reactive factors (Erythrocyte Sedimentation Rate [ESR] or C-Reactive Protein [CRP]).|Weeks 4, 8, 12, 16, 20, and 24|ITT Completers|||Percentage of Participants|||Number
2672626|NCT01468077|Secondary|DAS28 Score by Visit Among Participants Who Completed All Visits|Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score <3.2, and remission was defined as a DAS28 score <2.6.|Baseline, Weeks, 4, 8, 12, 16, 20, and 24|ITT Completers; n = the number of participants analyzed for the given parameter at the specific visit.|||scores on a scale||Standard Deviation|Mean
2672627|NCT01468077|Secondary|Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits|Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score <3.2, and remission was defined as a DAS28 score <2.6.|Weeks 4, 8, 12, 16, 20, and 24|ITT Completers|||Percentage of Participants|||Number
2672628|NCT01468077|Secondary|Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits|Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score <3.2, and remission was defined as a DAS28 score <2.6.|Weeks 4, 8, 12, 16, 20, and 24|ITT Completers|||Percentage of Participants|||Number
2672629|NCT01468077|Secondary|Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits|Improvement in Rheumatoid Arthritis (RA) disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response High sensitivity C-Reactive Protein (hsCRP), and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score less than (<)3.2, and remission was defined as a DAS28 score <2.6.|Weeks 4, 8, 12, 16, 20, and 24|ITT Completers|||Percentage of Participants|||Number
2672630|NCT01468077|Secondary|Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits|Increased levels of high density lipoproteins (HDL) equal to or greater than (≥)1.5 millimoles per liter (mmol/L), and low density lipoproteins (LDL) ≥4.1 mmol/L, and total cholesterol ≥5.1 mmol/L, are defined according to the Adult Treatment Panel III (ATP-III) guidelines.|Screening and Weeks 4, 8, 12, 16, 20, and 24|ITT Completers|||Percentage of Participants|||Number
2672631|NCT01468077|Secondary|Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits|"Increased liver enzyme values defined as Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) values of >1.5 times, or >3 times, or >5 times over the ULN. Almost none of the participants had increased measurements of AST, thus only values of ALT were presented. None of the participants presented with increased values of ALT above 3 or 5 ULN at any of the visits.~ITT Completers is defined as a subset of the participants in the ITT population who completed all study visits."|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Completers with liver enzyme datasets for each analyzed visit|||Percentage of Participants|||Number
2672632|NCT01468077|Secondary|Percentage of Participants Discontinuing Tocilizumab for Other Reasons|Participants that stopped the administration of tocilizumab and discontinued the study prematurely due to reasons other than an AE or SAE were analyzed.|Baseline and Weeks, 4, 8, 12, 16, 20, and 24|SAS Population|||Percentage of Participants|||Number
2674435|NCT01455519|Secondary|Change in Stair Climb Time|Time to climb 1 flight of stairs|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||seconds||Standard Error|Mean
2672637|NCT01467999|Primary|Reduction in Mean Number of Days of Cannabis Use Per Week|The reduction in cannabis consumption quantified by the number of days of cannabis use per week was assessed, as measured by the Time Line followback, reported week 1 compared to week 8.|Daily cannabis use reported during the 8 week trial or the length of the patient's participation|intent-to-treat sample|||days of use per week||Standard Deviation|Mean
2672638|NCT01467960|Primary|Detection of Apolipoprotein D|Apolipoprotein D (apoD)concentration in human serum as a potential marker for Parkinson's disease (PD)|Baseline||||microg / ml||Standard Deviation|Mean
2672639|NCT01467947|Secondary|Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies|Subjects with at least one positive result for inhibitory or non-inhibitory anti-C1-INH antibodies.|Baseline to approximately 9 months||||Subjects|||Number
2672640|NCT01467947|Primary|Number of Subjects With Inhibitory Anti-C1-esterase-inhibitor Antibodies|Subjects with no positive baseline result and at least one positive post-baseline result for inhibitory anti-C1-INH antibodies.|Baseline to approximately 9 months||||subjects|||Number
2672641|NCT01467934|Primary|Fever >= 100.4||8 days|Participants in analysis included those for whom both day 0 and day 1 temperature data was reported.|||percentage of participants|||Number
2672642|NCT01467882|Secondary|Percentage of Boys With Absence of Progression of Testis Volumes Compared to Baseline at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat boys, defined as all boys enrolled|||percentage of participants|||Number
2672643|NCT01467882|Secondary|Percentage of Girls With Regression of Uterine Length Compared to Baseline at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat girls, defined as all girls enrolled|||percentage of participants|||Number
2672644|NCT01467882|Secondary|Percentage of Children Achieving Stabilization of Sexual Maturation at Months 6 and 12||at Months 6 and 12|Intention to treat, defined as all participants enrolled|||percentage of participants|||Number
2672645|NCT01467882|Secondary|Percentage of Participants Without Bone Age / Chronological Age Ratio Increase From Baseline at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat, defined as all participants enrolled|||percentage of participants|||Number
2672646|NCT01467882|Secondary|Change From Baseline in Growth Velocity at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat, defined as all participants enrolled|||cm/year||Standard Deviation|Mean
2672647|NCT01467882|Secondary|Change From Baseline in Height-for-age Percentile Per 2000 CDC Growth Charts at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat, defined as all participants enrolled|||percentile||Standard Deviation|Mean
2672648|NCT01467882|Secondary|Change From Baseline in Height-for-age Z-score Per 2000 CDC Growth Charts at Months 6 and 12||Baseline to Months 6 and 12|Intention to treat, defined as all participants enrolled|||Z-score||Standard Deviation|Mean
2672649|NCT01467882|Secondary|Percentage of Children Without Higher Basal LH and Estradiol or Testosterone||at 2 days after second triptorelin injection (Day 171)|AOC Subset is defined as 50% of the population randomly assigned|||percentage of participants|||Number
2672650|NCT01467882|Secondary|Percentage of Children With Prepubertal Estradiol or Testosterone Levels at Months 1, 2, 3, 6, 9, and 12||at Months 1, 2, 3, 6, 9, and 12|Intention to treat, defined as all participants enrolled|||percentage of participants|||Number
2672651|NCT01467882|Secondary|Change From Baseline in Testosterone Levels at Months 1, 2, 3, 6, 9, and 12||Baseline to Months 1, 2, 3, 6, 9, and 12|Intention to treat boys, defined as all boys enrolled|||ng/dL||Standard Deviation|Mean
2672652|NCT01467882|Secondary|Change From Baseline in Estradiol Levels at Months 1, 2, 3, 6, 9, and 12||Baseline to Months 1, 2, 3, 6, 9, and 12|Intention to treat girls, defined as all girls enrolled|||ng/L||Standard Deviation|Mean
2672653|NCT01467882|Secondary|Change From Baseline in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) at Months 1, 2, 3, 6, 9, and 12||Baseline to Months 1, 2, 3, 6, 9, and 12|Intention to treat, defined as all participants enrolled|||IU/L||Standard Deviation|Mean
2672654|NCT01467882|Secondary|Percentage of Children Maintaining LH Suppression at </= 4 IU/L 30 Minutes After Leuprolide Stimulation From Month 6 to 12|This is a lab test to see what percentage of children stayed at the lower than normal before-puberty level from month 6 to month 12.|from Month 6 to 12|Intention to treat, defined as all participants enrolled|||percentage of participants|||Number
2672655|NCT01467882|Secondary|Percentage of Children With LH Suppression (LH ≤ 4 IU/L)30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 6, 9 and 12|This is a lab test to see what percentage of children were returned to lower than normal before-puberty levels by the drug at each time point.|at Months 1, 2, 3, 6, 9 and 12|Intention to treat, defined as all participants enrolled|||percentage of participants|||Number
2672656|NCT01467882|Secondary|Percentage of Children Maintaining LH Suppression at Prepubertal Levels 30 Minutes After Leuprolide Stimulation From Month 6 to 12|This is a lab test to see what percentage of children stayed at the normal before-puberty level from month 6 to month 12.|from Month 6 to 12|Intention to treat, defined as all participants enrolled|||percentage of participants|||Number
2672657|NCT01467882|Secondary|Percentage of Children With LH Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Months 1, 2, 3, 9 and 12|This is a lab test to see what percentage of children were returned to normal before-puberty levels by the drug at each time point.|at Months 1, 2, 3, 9 and 12|Intention to treat, defined as all participants enrolled|||percentage of participants|||Number
2672658|NCT01467882|Primary|Percentage of Children With Luteinizing Hormone (LH) Suppression to Prepubertal Levels 30 Minutes After Leuprolide Stimulation at Month 6|This is a lab test to see what percentage of participants were returned to normal before-puberty levels at Month 6.|Month 6|Intention to treat, defined as all participants enrolled|||percentage of participants||95% Confidence Interval|Number
2672668|NCT01467713|Secondary|Time From Randomization to Relapse Due to Depression|Relapse due to depression determined by any of the following criteria during the 12-month double-blind treatment period: PI judgment, MADRS ≥16, psychiatry hospitalization, ECT or any psychotropic medication change prescribed for the treatment of depressive episodes.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.|||Days||Standard Error|Mean
2672659|NCT01467713|Secondary|Quality of Life, Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Total Score|Q-LES-Q-SF is a self-administered 16-item questionnaire to assess the degree of enjoyment and satisfaction experienced by patients in various areas of daily functioning. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes relative to baseline indicate improved quality of life.|Baseline and Months 1, 2, 3, 4, 5, 6, 7, 8, 10 and 12|Participants from the Full Analysis Set, all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy, with available data.|||percent of maximum total score||Standard Deviation|Mean
2672660|NCT01467713|Secondary|Time From Randomization to Study Withdrawal for Any Reason|The time from randomization to study withdrawal during the 12 month double-blind treatment period. Withdrawal includes pretreatment event/adverse event; liver function test abnormalities; major protocol deviation; lost to follow-up; voluntary withdrawal; study termination; pregnancy; lack of efficacy; participant has a depressive, mania/hypomania or mixed episode; is hospitalized for psychiatric reasons; receives electroconvulsive therapy for bipolar disorder; receives any psychotropic medication change prescribed for the treatment of depression, mania/hypomania or mixed episodes; or any other reason.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy.|||days||Standard Error|Mean
2672661|NCT01467713|Secondary|Time From Randomization to Relapse Due to Psychotropic Medication Change Prescribed for the Treatment of Depression, Mania/Hypomania or Mixed Episodes|The time from randomization to relapse event during the 12 month double-blind treatment period due to any psychotropic medication change prescribed for the treatment of depression, mania/hypomania or mixed episode(s).|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.|||days||Standard Error|Mean
2672662|NCT01467713|Secondary|Time From Randomization to Relapse Due to Electroconvulsive Therapy (ECT) Administration|The time from randomization to relapse event during the 12 month double-blind treatment period due to ECT.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.|||days||Standard Error|Mean
2672663|NCT01467713|Secondary|Time From Randomization to Relapse Due to Psychiatric Hospitalization for Bipolar Disorder|The time from randomization to relapse event during the 12 months double-blind treatment period due to psychiatric hospitalization for bipolar disorder.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.|||days||Standard Error|Mean
2672664|NCT01467713|Secondary|Time From Randomization to Relapse Due to Mixed Episode|Relapse due to Mixed episode is determined by PI judgement and/or MADRS score ≥16 and YMRS total score ≥16. MADRS is a 10-item scale that measures overall severity of depressive symptoms rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. YMRS is a four item scale to assess manic symptoms, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), with 7 items rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.|||days||Standard Error|Mean
2672665|NCT01467713|Secondary|Time From Randomization to Relapse Due to Mania/Hypomania|Relapse due to mania/hypomania is determined by the primary investigator (PI) judgement and/or a YMRS total score ≥16. YMRS is a 11 item scale with four items scale to assess manic symptoms, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), with 7 items rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe) with higher scores reflecting greater levels of mania. The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60.|Randomization to 12 Month double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.|||days||Standard Error|Mean
2672666|NCT01467713|Secondary|Time From Randomization to Relapse Due to Depression From PI Judgement and/or MADRS ≥16|The time from randomization to relapse event during the 12 month double-blind treatment period due to depression, determined by the PI judgement and/or a MADRS score ≥16. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.|||days||Standard Error|Mean
2672667|NCT01467713|Secondary|Time From Randomization to Relapse Due to Mania/Hypomania or Mixed Episode|Relapse due to mania/hypomania or mixed episode is determined by any of the following criteria: PI judgment, mania/hypomania [YMRS ≥16], mixed episode [MADRS ≥16 and YMRS ≥16], psychiatry hospitalization, ECT or any psychotropic medication change prescribed for the treatment of mania/hypomania or mixed episodes.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.|||days||Standard Error|Mean
2672750|NCT01467076|Secondary|Length of Hospital Stay|Length of stay in hospital from birth to discharge home.|From birth to discharge home|Two infants in the aerosolized saline group, and 2 infants in the lowd ose IPGE1 group and high dose IPGE1 Group were discharged home/chronic care.|||Days||Full Range|Mean
2672669|NCT01467713|Primary|Time From Randomization to Any Relapse|The time from randomization to relapse over 12 months double-blind treatment period as determined by the Principal Investigator (PI) or defined by any of the following criteria: depression [Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥16]; mania/hypomania [Young Mania Rating Scale (YMRS) total score ≥14]; mixed episode [MADRS score ≥16 and YMRS total score ≥16]; or, whether participant receives psychiatric hospitalization for bipolar disorder, electroconvulsive therapy (ECT) or any psychotropic medication change prescribed for the treatment of depression, mania/hypomania or mixed episodes.|Randomization to Month 12 double-blind treatment period|Full Analysis Set included all randomized participants who received at least 1 dose of study drug and had at least one valid post-baseline value for assessment of primary efficacy. Participants without relapse were censored.|||Days||Standard Error|Mean
2672670|NCT01467700|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 6|The SDS comprises patient-rated items designed to measure the extent to which the subject's life is impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his or her (1) work, (2) social life or leisure activities, and (3) home life or family responsibilities, are impaired by his or her symptoms on 10-point visual analogue scales from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment. There are verbal descriptors for the points on the scales as well as numerical scores that provide more precise levels of the verbal descriptors. In addition, the SDS addresses the number of days lost and the number of days under-productive due to the symptoms. A negative change from Baseline indicates improvement. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.|||score on a scale||Standard Error|Least Squares Mean
2672671|NCT01467700|Secondary|Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self-Rated16 (QIDS-SR16) Total Score at Week 6|The 16 item QIDS-SR16 version is designed to assess the severity of depressive symptoms. The QIDS-SR16 assesses all the criterion symptom domains designated by the American Psychiatry Association Diagnostic and Statistical Manual of Mental Disorders - 4th edition, DSM-IV, to diagnose a major depressive episode. QIDS-SR16 assessment has been used to screen for depression and also to measure symptom severity. This scale is also used to distinguish response from remission, as well as to quantify between group treatments effects in open label and randomized controlled trials. The patient is asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27. Higher scores indicate greater severity of impairment. A negative change from Baseline indicates improvement. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.|||score on a scale||Standard Error|Least Squares Mean
2672672|NCT01467700|Secondary|Percentage of Participants With MADRS Remission at Week 6, With Remission Defined as a MADRS Total Score ≤10|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.|||percentage of participants|||Number
2672673|NCT01467700|Secondary|Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) at Week 6|"The CGI-S at week 6 relative to Baseline. The CGI-S assesses the clinician's impression of the participant's current state of mental illness and consists of one question for the investigator: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on a seven-point scale (1=normal, not ill at all; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill). Higher scores indicate greater severity of illness. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis."|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.|||score on a scale||Standard Error|Least Squares Mean
2672674|NCT01467700|Secondary|Clinical Global Impression Scale-Improvement (CGI-I) Score at Week 6|"The CGI-I assesses the clinician's impression of the participant's state of mental illness improvement and consists of one question for the investigator: Compared to his condition at the start of the study, how much has this patient changed? which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change relative to baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater severity of illness. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis."|6 Weeks|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.|||score on a scale||Standard Error|Least Squares Mean
2672675|NCT01467700|Secondary|Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 6|The YMRS total score at week 6 relative to baseline. YMRS is a four item scale to assess manic symptoms, rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe), with 7 items rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe) with higher scores reflecting greater levels of mania. The YMRS total score is calculated as the sum of the 11 individual item scores and ranges from 0-60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement. A MMRM model was used for analyses with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.|||score on a scale||Standard Error|Least Squares Mean
2672676|NCT01467700|Secondary|Percentage of Participants With MADRS Response at Week 6, With Response Defined as a ≥ 50% Decrease in the MADRS Total Score From Baseline|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.|||percentage of participants|||Number
2672677|NCT01467700|Secondary|Change From Baseline in Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) Short Form Total Score at Week 6|Q-LES-Q -SF is a self-administered, 16-item questionnaire to assess the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning, such as social relationships, living/housing, physical health, medication, and global satisfaction. The questionnaire consists of 16 items rated by the participants on a 5-point scale. Of these, 14 items are summed to produce a total quality of life score with a maximum of 70 points. In addition, there are two global items that are scored individually. These items rate satisfaction with study medication and overall life satisfaction. The questionnaire is usually scored as a percent of total possible score, with higher scores indicating better health status. A positive change from Baseline indicates improvement. A MMRM model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from FAS, all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.|||percent of maximum score on a scale||Standard Error|Least Squares Mean
2672678|NCT01467700|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 6|The change between MADRS score at week 6 relative to Baseline. MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (i.e., apparent sadness, reported sadness, inner tension, etc.) rated on a 7-point Likert scale from 0 (normal) to 6 (most abnormal) with a total score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates improvement. A mixed measures repeated measures (MMRM) model was used for analysis with baseline*week, pooled center, week, treatment, baseline, and week*treatment as factors in the analysis.|Baseline and Week 6|Participants from full analysis set (FAS), all randomized participants who, received at least 1 dose of study drug, and had at least 1 valid post-baseline value for assessment of primary efficacy, with data available for analyses.|||score on a scale||Standard Error|Least Squares Mean
2672679|NCT01467661|Primary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities|Standard 12-Lead ECG analysis was performed to identify the ECG abnormalities. Clinically significant abnormalities like QT prolongation, atrial fibrillation, were decided by the investigator during the study.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).|||participants|||Number
2672680|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs Related to Vital Signs During Post-marketing Trial|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).|||percentage of participants|||Number
2672681|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs Related to Vital Signs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).|||percentage of participants|||Number
2672682|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result During Post-marketing Trial|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).|||percentage of participants|||Number
2673082|NCT01464697|Secondary|Anxiety|Daily average rating of anxiety (0-4) from prospective daily calendar records. Outcome is the average daily rating during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Scale name: Anxiety (4=Worst, 0=None)|12 weeks||||Units on a ordinal Scale||Standard Deviation|Mean
2672683|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs Related to Clinical Laboratory Result|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).|||percentage of participants|||Number
2672684|NCT01467661|Primary|Percentage of Participants With TEAEs and TESAEs During Post-marketing Trial|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).|||percentage of participants|||Number
2672685|NCT01467661|Primary|Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.|From start of study treatment (SPD422-308) up to 12 days after the last dose of investigational product|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).|||percentage of participants|||Number
2672686|NCT01467661|Primary|Percentage of Participants Who Achieved Shift From Baseline in Platelet Count During Post-marketing Trial|Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who had platelet count <600 x 10^9 platelet per liter and greater than equal (>=) 600 x 10^9 platelet per liter at the final assessment as a shift from baseline during the post marketing trial was reported. Percentage of participants with shift = number of participants with shift / post-marketing safety analysis set (33 participants) * 100.|Baseline and final assessment (within 5 days of the last dose of investigational product)|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). Here, n = number for participants evaluable at the specific category.|||percentage of participants|||Number
2672687|NCT01467661|Primary|Percentage of Participants Who Achieved Shift From Baseline in Platelet Count|Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last nonmissing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who had platelet count <600 x 10^9 platelet per liter and greater than equal (>=) 600 x 10^9 platelet per liter at the final assessment as a shift from baseline was reported. Percentage of participants with shift = number of participants with shift / Safety analysis set (53 participants) * 100.|Baseline and final assessment (within 5 days of the last dose of investigational product)|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915). Here, n = number for participants evaluable at the specific category.|||percentage of participants|||Number
2672688|NCT01467661|Primary|Percentage of Participants Who Achieved Platelet Count Less Than (<) 600 During Post-marketing Trial|Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who achieved platelet count <600 x 10^9 platelets per liter during the post-marketing trial were reported.|Baseline and final assessment (within 5 days of the last dose of investigational product)|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). Here, n = number of participants analysed at specific time point.|||percentage of participants|||Number
2672689|NCT01467661|Primary|Percentage of Participants Who Achieved Platelet Count Less Than (<) 600|Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit). Participants who achieved platelet count <600 x 10^9 platelets per liter at each visit were reported.|Baseline, Week 1, Month 1-12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, and final assessment (within 5 days of the last dose of investigational product)|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915). Here, n = number of participants analysed at specific time point.|||percentage of participants|||Number
2674989|NCT01451398|Secondary|Incidence of Total Hypoglycemia|Hypoglycemia, defined as blood glucose <= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates.|Baseline to Week 24|Safety population|||percentage of participants|||Number
2672690|NCT01467661|Primary|Change From Baseline in Platelet Count During Post-marketing Trial at Final Assessment|Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit).|Baseline and final assessment (within 5 days of the last dose of investigational product)|Post-marketing trial safety analysis set included all participants in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661). Here, n = number of participants analysed at specific time point.|||10^9 platelets per liter (10^9/L)||Standard Deviation|Mean
2672691|NCT01467661|Primary|Change From Baseline in Platelet Count at Final Assessment|Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 [NCT01467661], or early termination visit either in SPD422-308 [NCT01214915] or SPD422-309 [NCT01467661], or last available study visit).|Baseline and final assessment (within 5 days of the last dose of investigational product)|Safety analysis set included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).|||10^9 platelets per liter (10^9/L)||Standard Deviation|Mean
2672692|NCT01467583|Secondary|To Determine Number of Participants Who Experienced a Bleeding Event, Either Major or Minor, and to Determine the Number of Participants Who Experienced a Venous Thromboembolism During the Study Period|Safety will be assessed through monitoring for clinical signs of bleeding. Major and minor bleeding will be documented. In additions, venous doppler studies of the bilateral lower extremities will be performed at study entry and study completion to monitor for any evidence of venous thromboembolism during the study period. We will report on the number of participants experiencing an adverse event during the study|2 years||||participants|||Number
2672693|NCT01467583|Primary|To Determine if an Adjusted-dose of Fondaparinux 2.5 mg Subcutaneously (SQ) q48 hr in Critically Ill Patients With Renal Failure Will Achieve Peak and Trough Levels Similar to Patients With Normal Renal Function on 2.5 mg SQ Daily Dosing of Fondaparinux.|Fondaparinux Peak Levels measured at time +3 hours after the dose, and Trough Levels, measured at time + 47 hours post-dose around the first 5 doses of fondaparinux and then every 3rd dose thereafter. Levels will be sent to our hospital laboratory and performed using a calibrated fondaparinux assay.|2 years||||mcg/ml||Standard Deviation|Mean
2672694|NCT01467570|Secondary|ORS Intake at 4 h|% of prescribed ORS that was consumed during first 4 hours|4 hrs||||percentage of prescribed ORS||Standard Deviation|Mean
2672695|NCT01467570|Secondary|Adverse Events|any adverse event, providing a description if related or not related to study intervention|24 hours||||participants|||Number
2672696|NCT01467570|Secondary|Hospitalization|need for hospitalization within a week|1 week||||participants|||Number
2672697|NCT01467570|Secondary|Return Visit to the Emergency Department|Return visit to the emergency department within a week|1 week||||participants|||Number
2672698|NCT01467570|Secondary|Duration of Diarrhea (Hrs)|Time of diarrhea in hours|7days||||hrs||Standard Deviation|Mean
2672699|NCT01467570|Secondary|Weight Gain in Gram|Weight gain in gram (in the first 24 hours, and total)|24 hours||||gram||Standard Deviation|Mean
2672700|NCT01467570|Secondary|ORS Intake in ml|ORS intake in ml (in the first 24 hours, and total)|24 hours||||ml||Standard Deviation|Mean
2672701|NCT01467570|Secondary|Vomiting|Vomiting starting or progressing in the first 24 hours of therapy|24 hours||||participants|||Number
2672702|NCT01467570|Secondary|Unscheduled Intravenous Therapy|Need for intravenous therapy within 24 hours|24 hours||||participants|||Number
2672703|NCT01467570|Primary|Number of Participants That Were Successfully Rehydrated|"The following components are included in primary outcome:~resolution of signs of dehydration~adequate weight gain~production of urine output during the trial"|Proportion of successfully rehydrated at 24 hours||||Participants|||Number
2672704|NCT01467557|Secondary|Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys|The response set for each question was a 5-level likert scale. Intensity of discomfort, dryness, blurriness were measured with the likert scale from 0(Never Have It) to 5(Very Intense). Frequency of discomfort, dryness, blurry vision, removal of lenses, and eye closure(how often you wanted to close them) were measured with the likert scale from 1(Never) to 5(Constantly). The sum of all responses was recorded for each subject and then the average sum for all subjects was reported. The average can range from 0- 40 (continuous).|Baseline, 2 Week, 4 Month or 12 Month surveys|The analysis population consists of all subjects that were considered to be experienced contact lens wearers. Subjects were considered to be experienced contact lens wearers if subjects were assigned daily disposable lens at all evaluation points.|||units on a scale||Standard Deviation|Mean
2672705|NCT01467557|Primary|Incidence of Adverse Events|"Adverse events were reported by subjects via the electronic surveys if they responded yes to the question Since we last contacted you, have you experienced a red or painful eye that required a visit to an eye doctor or emergency room?. Consensus diagnosis was made after review of clinical records by Adjudication Panel."|Self-report at 2 Week, 4 Month or 12 Month surveys|The analysis population consisted of subjects that were enrolled into this study. (i.e subjects that met all study eligibility criteria)|||participants|||Number
2672706|NCT01467505|Other Pre-specified|Percentage of Participants With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)||4 weeks after last planned dose of study drug (up to Week 52)|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.||||||
2672721|NCT01467492|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes SAE as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.|Up to Week 52|Safety Set.|||percentage of participants|||Number
2672707|NCT01467505|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"Any adverse change from the participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents (including placebo, if applicable) administered during the course of the study."|Baseline up to Week 52|Safety Set included all participants who received at least 1 dose of study drug.|||participants|||Number
2672708|NCT01467505|Secondary|Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.||||||
2672709|NCT01467505|Secondary|Percentage of Participants With Histological Evidence of Stabilization or Improvement in Inflammation Grade or Fibrosis Stage||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.||||||
2672710|NCT01467505|Secondary|Percentage of Participants With Biopsy Confirmed and Treated Rejection||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.||||||
2672711|NCT01467505|Secondary|Percentage of Participants Requiring Dose Titration of Immunosuppressant Medications||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.||||||
2672712|NCT01467505|Secondary|Pharmacokinetics of Telaprevir, Peg-IFN, RBV , and Selected Immunosuppressant Medications (Tacrolimus and Cyclosporine)||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.||||||
2672713|NCT01467505|Secondary|Percentage of Participants With Viral Relapse||48 weeks|Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.||||||
2672714|NCT01467505|Secondary|Percentage of Participants With On-Treatment Virologic Failure|On-treatment virologic failure was defined as subjects who met futility or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). Data for this outcome was not planned to be reported by prior response.|Baseline up to Week 48|Safety Set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2672715|NCT01467505|Secondary|Percentage of Participants With Extended Rapid Viral Response (eRVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment.|Week 4 and Week 12|Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
2672716|NCT01467505|Secondary|Percentage of Participants With Rapid Viral Response (RVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment.|Week 4|Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
2672717|NCT01467505|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)|SVR24 was defined as an undetectable HCV RNA Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.|24 weeks after last planned dose of study drug (up to Week 72)|Safety Set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed = participants evaluable for this measure and n = participants evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
2672718|NCT01467505|Primary|Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)|SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).|12 weeks after last planned dose of study drug (up to Week 60)|Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
2672719|NCT01467492|Other Pre-specified|Plasma Concentration of Telaprevir, Peginterferon Alfa-2a (Peg-IFN) and Ribavirin (RBV)||48 weeks|Pharmacokinetic sampling was not performed as per changes in planned analysis (protocol amendment); hence no data was collected.||||||
2672720|NCT01467492|Secondary|Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region|Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by race and by prior response.|up to Week 72|FA Set.|||participants|||Number
2672748|NCT01467427|Primary|Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) Defined as Titre Above or Equal to 0.6 Bethesda Units (BU)|Inhibitors were analysed with either the Nijmegen modified factor IX Bethesda assay or a heat/cold Nijmegen modified factor IX Bethesda assay. Number of subjects who developed inhibitory antibodies against factor IX are reported.|From 0 to 52 weeks|Safety analysis set included all subjects exposed to nonacog beta pegol|||Number of subjects|||Number
2672722|NCT01467492|Secondary|Percentage of Participants With On Treatment Virologic Failure|On treatment virologic failure was defined as meeting any futility rule or completing assigned treatment duration and having detectable HCV RNA at EOT. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Futility rules: 1) Virologic breakthrough (at least 1 log10 increase from nadir or confirmed detectable HCV RNA after undetectable HCV RNA) from Day 1 through Week 24 or 48 (depending on treatment duration); 2) HCV RNA >1000 IU/mL during Weeks 4 to 12, inclusive; 3) Detectable HCV RNA after Week 12. Percentages are calculated by using total number in FA set as denominator, in each category.|Week 2, 4, 8, 12, 16, 24, 28, 36, 40, and 48|FA Set.|||percentage of participants|||Number
2672723|NCT01467492|Secondary|Percentage of Participants With Virologic Breakthrough|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Virologic breakthrough on treatment was defined as an increase of at least 1 log10 from nadir or confirmed detectable HCV RNA (>=lower limit of quantification) after undetectable HCV RNA (<lower limit of quantification). Percentages are calculated by using total number in FA set as denominator, in each category.|Week 2, 4, 8, and 12|FA Set.|||percentage of participants|||Number
2672724|NCT01467492|Secondary|Percentage of Participants With Relapse|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Relapse was defined as having undetectable HCV RNA (<lower limit of quantification) at actual end of treatment (EOT) and followed by detectable HCV RNA (>=lower limit of quantification) during follow-up.|4 weeks (Wk) (up to Week 52), 12 weeks (up to Week 60) and 24 weeks (up to Week 72) after actual EOT|FA Set. Here number of participants analyzed signifies participants with undetectable HCV RNA (HCV RNA <lower limit of quantification) at actual EOT and n signifies participants with undetectable HCV RNA at actual EOT for specified category.|||percentage of participants|||Number
2672725|NCT01467492|Secondary|Percentage of Participants With Extended Rapid Viral Response (eRVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.|Week 4 and Week 12|FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
2672726|NCT01467492|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)|SVR24 was defined as an undetectable HCV RNA Levels (<lower limit of quantification) at 24 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.|24 weeks after last actual dose of study drug (up to Week 72)|FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
2672727|NCT01467492|Primary|Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)|SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).|12 weeks after last actual dose of study drug (up to Week 60)|FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
2672728|NCT01467479|Secondary|Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region|Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by HAART treatment.|Baseline, follow-up (Week 96)|Full analysis set. Here number of participants analyzed = participants who were evaluable for this measure and n = participants evaluable for specified categories.|||participants|||Number
2672729|NCT01467479|Secondary|Maximum (Cmax), Minimum (Cmin), and Average Plasma Concentration (Cavg)|Cmax, Cmin, and Cavg were reported for atazanavir (ATV), efavirenz (EFV), raltegravir (RAL), and telaprevir.|Day -14 to Day -1 and Week 1 for ATV, EFV, and RAL; Week 1 for telaprevir|Full Analysis set.Here, n = participants evaluable for specified category for each arm, respectively.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2672730|NCT01467479|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.|Up to Week 52|Safety set.|||percentage of participants|||Number
2672731|NCT01467479|Secondary|Percentage of Participants With Undetectable HCV RNA at End of Treatment (EOT)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Percentage of participants with undetectable HCV RNA (<lower limit of quantification) at EOT (up to Week 48) are reported. Data for this outcome was not planned to be reported by prior response.|EOT (up to Week 48)|Full analysis set included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2672732|NCT01467479|Secondary|Percentage of Participants With Extended Rapid Viral Response (eRVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.|Week 4 and Week 12|Safety set. Here, n = participants evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
2672733|NCT01467479|Secondary|Percentage of Participants With Rapid Viral Response (RVR)|The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. RVR was defined as undetectable HCV RNA (<lower limit of quantification) 4 weeks after the start of study treatment.|Week 4|Safety set. Here, n = participants evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
2672734|NCT01467479|Secondary|Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR 24)|SVR 24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 24 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).|24 weeks after last planned dose of study drug (up to Week 72)|Safety set. Here number of participants analyzed = participants evaluable for this measure and n = participants evaluable for specified categories, for each arm, respectively.|||percentage of participants|||Number
2672735|NCT01467479|Primary|Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)|SVR 12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (<lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma hepatitis C virus ribonucleic acid (HCV RNA) level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).|12 weeks after last planned dose of study drug (up to Week 60)|Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.|||percentage of participants|||Number
2672736|NCT01467466|Primary|Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Oral N-Acetylcysteine With Oral Placebo.|Death will be based on medical record and/or vital status registry documentation Need for acute dialysis will be defined as the initiation of any modality of renal replacement (intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or sustained low-efficiency dialysis) Persistent decline in kidney function will be defined as an increase in serum creatinine of at least 50% from the baseline value collected pre-angiography to the measurement taken 90 days following the angiography.|Within 90 days following angiography||||Participants|||Count of Participants
2672737|NCT01467466|Primary|Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Intravenous Sodium Bicarbonate With Intravenous Sodium Chloride.|Death will be based on medical record and/or vital status registry documentation Need for acute dialysis will be defined as the initiation of any modality of renal replacement (intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or sustained low-efficiency dialysis) Persistent decline in kidney function will be defined as an increase in serum creatinine of at least 50% from the baseline value collected pre-angiography to the measurement taken 90 days following the angiography.|Within 90 days following angiography||||Participants|||Count of Participants
2672738|NCT01467427|Secondary|Haemostatic Effect of N9-GP in Treatment of Bleeding Episodes by 4-point Categorical Scale for Haemostatic Response (Excellent, Good, Moderate and Poor)||From week 52 until the last patient has completed the trial (no later than 31-Oct-2018)|||||||
2672739|NCT01467427|Secondary|Trough Level (Steady State)||From week 52 until the patient has completed the trial (no later than 31-Oct-2018)|||||||
2672740|NCT01467427|Secondary|Number of Bleeding Episodes During Prophylaxis||From week 52 until the last patient has completed the trial (no later than 31-Oct-2018)|||||||
2672741|NCT01467427|Primary|Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) Defined as Titre Above or Equal to 0.6 Bethesda Units (BU)||From week 52 until the last patient has completed the trial (no later than 31-Oct-2018)|||||||
2672742|NCT01467427|Secondary|Terminal Half-life (t1/2)||Week 0 (30 minutes until one week after first exposure)|Full analysis set.|||hours||Geometric Coefficient of Variation|Geometric Mean
2672743|NCT01467427|Secondary|Trough Level (Steady State)|The mean pre-dose factor IX levels was measured with the one-stage clotting assay during the trial. The estimated mean of the lowest activity recorded immediately before next dose was given from week 4 to week 52. The analysis is based on a mixed model on the log-transformed plasma concentrations with subject as a random effect and the mean trough level is presented back-transformed to the natural scale.|Week 4 to 52 weeks|Full analysis set.|||U/mL||95% Confidence Interval|Mean
2672744|NCT01467427|Secondary|Trough Level (Single-dose )|The mean pre-dose factor IX levels was measured with the one-stage clotting assay during the trial. Geometric mean of the lowest activity of factor IX recorded at week 0 (immediately before next dose was given).|Week 0 (one week after first exposure)|Full analysis set. Number of subjects analysed=Subjects who were evaluable for this parameter.|||U/mL||Geometric Coefficient of Variation|Geometric Mean
2672745|NCT01467427|Secondary|Incremental Recovery at 30 Minutes (IR30min)|The incremental recovery was calculated by dividing the baseline-subtracted factor IX activity (U/mL) measured in plasma 30 min after dosing by the dose injected at time 0 expressed as U/kg body weight.|Week 0 (30 minutes after first exposure)|Full analysis set. Number of subjects analysed=Subjects who were evaluable for this parameter.|||(U/mL)/(U/kg)||Geometric Coefficient of Variation|Geometric Mean
2672746|NCT01467427|Secondary|Haemostatic Effect of N9-GP in Treatment of Bleeding Episodes by 4-point Categorical Scale for Haemostatic Response (Excellent, Good, Moderate and Poor)|"Description of the haemostatic effect of nonacog beta pegol when used for treatment of bleeding episodes was measured and listed according to the four point scale for haemostatic response as below:~Excellent - abrupt pain relief and/or clear improvement in objective signs of bleeding within 8 hours after a single infusion.~Good - noticeable pain relief and/or improvement in signs of bleeding within 8 hours after a single injection.~Moderate - probable or slight beneficial effect within the first 8 hours after the first injection but requiring more than one infusion within 8 hours.~Poor - no improvement, or worsening of symptoms within 8 hours after two injections.~A success rate was calculated based on counting good or excellent as successes and poor and moderate as failures."|From 0 to 52 weeks|Full analysis set. Number of subjects analysed=subjects who experienced bleeding episodes.|||percentage of bleeding episodes|||Number
2672747|NCT01467427|Secondary|Number of Bleeding Episodes During Prophylaxis|The number of bleeding episodes per subject during routine prophylaxis was assessed using the individual annualised bleeding rates (bleeding episodes per subject per year).|From 0 to 52 weeks|Full analysis set (FAS) included all subject with efficacy data after exposure to nonacog beta pegol.|||bleeds/subject/year||Inter-Quartile Range|Median
2672749|NCT01467271|Primary|Number of Patients With Moderate to Severe Renal Impairment Who Develop Nephrogenic Systemic Fibrosis (NSF) After Administration of Dotarem||All patients were followed up during 2 years after Dotarem administration.||||Participants|||Count of Participants
2672751|NCT01467076|Secondary|Number of Days of Supplemental Oxygen (O2) Used|Number of days from birth during which the FiO2 at some point was > 0.21.|From birth through status (death, transfer or discharge)|All 3 infants in the aerosolized saline group, and the 2 infants in the lower dose IPGE1 group and high dose IPGE1 Group have the number of days on supplemental oxygen from birth to death, transfer or discharge.|||Days||Full Range|Mean
2672752|NCT01467076|Secondary|Duration of Mechanical Ventilation|Duration the infant is on Mechanical Ventilation from birth through status (death, transfer or discharge)|From birth through status (death, transfer or discharge)|All 3 infants in the aerosolized saline group, and the 2 infants in the lower dose IPGE1 group and high dose IPGE1 Group have the number of days on mechanical ventilation from birth to death, transfer or discharge.|||Days||Full Range|Mean
2672753|NCT01467076|Secondary|Need for Extracorporeal Membrane Oxygenation (ECMO)|ECMO provided at the institution for the infant after discontinuation of study aerosol.|From after discontinuation of study aerosol through status (death, transfer, or discharge).|All 3 infants in the control group, 2 infant in the Low dose and 2 infants in the High dose IPGE1 groups have data on ECMO use at the institution after discontinuation of study aerosol.|||Participants|||Count of Participants
2672754|NCT01467076|Secondary|Death|Deaths prior to discharge home.|From birth through status (death, transfer, or discharge).|All 3 infants in the control group, 2 infant in the Low dose and 2 infants in the High dose IPGE1 groups have status data (death, transfer or discharge).|||Participants|||Count of Participants
2672755|NCT01467076|Secondary|Duration of iNO Therapy|Duration the infant is on INO from initial administration of INO to final discontinuation of INO.|From date of first administration of INO to date of final discontinuation of INO.|The date of final discontinuation of INO was recorded for 2 infants in the control group, 1 infant in the low dose and all 2 infants in the high dose group.|||hours||Full Range|Mean
2672756|NCT01467076|Secondary|Need for Inhaled Nitric Oxide (INO) 72 Hours After INO|Administration of INO continued after the Infant was on INO for 72 hours|Date of first administration of INO to date of final discontinuation of INO|Date of final discontinuation of INO was not available for 1 infant in the Control group and 1 infant in the LOW DOSE IPGE1 group|||Participants|||Count of Participants
2672757|NCT01467076|Secondary|Change in Oxygenation Index (OI)|Change in OI based on the arterial blood gases (ABG) measurements obtained at 60±15 minutes and ABG obtained 4±2 hours after start of study aerosol.|Measurement of ABG at 60±15 minutes and 4±2 hours after start of study aerosol.|To gauge change in OI for each group we present both the average and the range of the difference between the two OI ABG measurements (measurement at 4±2 hours - measurement at 60±15 minutes after start of study aerosol). A positive difference indicates an increase in OI measurement; a negative difference indicates a decrease in OI measurement.|||oxygenation index||Full Range|Mean
2672758|NCT01467076|Secondary|Change in Partial Pressure of Oxygen in the Blood (PaO2)|Changes in PaO2 based on the arterial blood gases (ABG) measurements obtained after 60 minutes and ABG obtained 4 hours after start of study aerosol.|Measurement of ABG at 60±15 minutes and 4±2 hours after start of study aerosol.|To gauge the improvement in PaO2 for each group, the average of the difference between the two PaO2 ABG measurements (measurement at 4±2 hours-measurement at 60±15 minutes after start of study aerosol) and the range(minimum, maximum) of the differences between OI ABG measurements at the two time points within each group are presented here.|||mmHg||Full Range|Mean
2672759|NCT01467076|Primary|Feasibility Assessed as the Number of Participants Who Were Enrolled in the Study|The primary outcome is the ability to recruit adequate number of infants (n=50) in a 9 month period without excessive (>20%) protocol violations.|From study start through 9 months after 75% of the participating sites are enrolling|Late preterm & term infants ≤ 7 days postnatal age undergoing conventional ventilation (CNV) or high frequency oscillatory ventilation (HFOV) for NHRF (including perinatal aspiration syndrome, suspected/proven pneumonia/sepsis, respiratory distress syndrome, idiopathic PPHN or suspected pulmonary hypoplasia) with suboptimal response to INO|||participants|||Number
2672760|NCT01467037|Other Pre-specified|Vaccine Effectiveness of RV1|"RV1 vaccine effectiveness (VE) was investigated using a subset of active surveillance participants age-eligible to receive 2-doses of RV1 vaccine, defined as participants (i) <15 weeks of age as of program implementation (November 1, 2011), and (ii) ≥16 weeks of age at symptom onset. These ages corresponded to the maximum recommended age of administration for the first RV1 dose at program implementation, and the recommended age of second dose administration, respectively.~Only valid RV1 vaccinations administered ≥14 days prior to symptom onset were considered. RV1 VE was estimated as (1 − exposure odds ratio) × 100. Based upon our sampling scheme, the exposure odds ratio from our analyses approximates the rate ratio."|From February 1, 2012 to May 31, 2014||||adjusted VE||95% Confidence Interval|Number
2672761|NCT01467037|Primary|Matched VE Participants|"RV1 vaccine effectiveness (VE) was investigated using a subset of active surveillance participants age-eligible to receive 2-doses of RV1 vaccine, defined as participants (i) <15 weeks of age as of program implementation (November 1, 2011), and (ii) ≥16 weeks of age at symptom onset. These ages corresponded to the maximum recommended age of administration for the first RV1 dose at program implementation, and the recommended age of second dose administration, respectively.~We estimated RV1 VE of 2- versus 0-doses and ≥1- versus 0-doseto prevent rotavirus hospitalization or emergency visits. Only valid RV1 vaccinations administered ≥14 days prior to symptom onset were considered. Children vaccinated with RV5 (private market,minimal penetrance) were excluded."|From February 1, 2012 to May 31, 2014|Rotavirus vaccination history by rotavirus disease status among matched VE participants|||participants|||Number
2672762|NCT01466985|Secondary|Time to Maximum Plasma Concentration (Tmax) of Doravirine on Day 7|The Tmax of doravirine on Day 7 was determined in the doravirine treatment arms.|Predose and 1, 2, 4, 6, 8, 10, 12 and 24 hours postdose on Day 7|All participants who received ≥1 dose of doravirine are included.|||Hours||Full Range|Median
2672763|NCT01466985|Secondary|Plasma Concentration 24 Hours Postdose (C24hr) of Doravirine on Day 7|The C24hr of doravirine on Day 7 was determined in the doravirine treatment arms.|24 hours postdose on Day 7 (Day 8)|All participants who received ≥1 dose of doravirine are included.|||nM||90% Confidence Interval|Geometric Mean
2672764|NCT01466985|Secondary|Maximum Plasma Concentration (Cmax) of Doravirine on Day 7|The Cmax of doravirine on Day 7 was determined in the doravirine treatment arms.|Predose and 1, 2, 4, 6, 8, 10, 12 and 24 hours postdose on Day 7|All participants who received ≥1 dose of doravirine are included.|||nM||90% Confidence Interval|Geometric Mean
2672765|NCT01466985|Secondary|Area Under the Plasma Concentration Time Curve From Dosing to 24 Hours Postdose (AUC0-24hr) of Doravirine on Day 7|The AUC0-24hr of doravirine on Day 7 was determined in the doravirine treatment arms.|Predose and 1, 2, 4, 6, 8, 10, 12 and 24 hours postdose on Day 7|All participants who received ≥1 dose of doravirine are included.|||uM*hr||90% Confidence Interval|Geometric Mean
2672766|NCT01466985|Primary|Percentage Change From Baseline in HIV-1 Ribonucleic Acid (RNA) Viral Load|The change from baseline to Day 7 in plasma HIV RNA viral load was determined for each arm. Results are expressed as change in HIV RNA log10 copies/mL after 7 daily doses of doravirine or placebo. It was hypothesized that at least 1 dose of doravirine would be superior to placebo as documented by the upper bound of the 90% confidence interval <-1. Plasma HIV RNA levels were determined using the Abbott RealTime HIV assay which has a linear range from 40 to 10 million copies/mL.|Baseline and Day 7|All participants who received ≥1 dose of study drug are included (results are presented according to actual treatment received).|||Percentage change||95% Confidence Interval|Least Squares Mean
2672767|NCT01466881|Other Pre-specified|Aurora Kinase A Expression|To explore the association between pre-treatment aurora kinase A expression in tumor biopsies as measured by fluorescence in situ hybridization (FISH) and objective response rate in patients with PTCL treated with MLN8237|Baseline|Eligible patients who consented for correlative studies and had Aurora kinase A expression measured.|||proportion of positivity||Standard Deviation|Mean
2672768|NCT01466881|Secondary|To Evaluate the Safety and Tolerability of MLN8237 (Number of With Grade 3 Through Grade 5 Adverse Events That Are Related to MLN8237)|Incidence of toxicity as assessed by the Common Terminology Criteria for Adverse Events version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Up to 1 year after registration|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
2672769|NCT01466881|Secondary|Progression Free Survival (PFS)|Measured from date of registration to date of first observation of progressive disease or death due to any cause. Patients last known to be alive and without report of progressive disease are censored at date of last contact. Progressive disease is at least 50% increase in the sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed or ≥ 50% increase in the greatest transverse diameter (GTD) of any node > 1 cm in shortest axis, or ≥ 50% increase in the SPD of other target measurable lesions over the smallest sum observed. New bone marrow involvement. New lesion > 1.5 cm in longest axis, or ≥ 50% increase in GTD of any previously involved node with a diameter ≤ 1.0 cm in the short axis such that its longest axis is now > 1.5 cm. Lymph nodes with long axis is > 1.5 cm, or if the both the long and short axes are > 1 cm. PET should be positive if positive PET at baseline.|Up to 2 years after registration|Only eligible patients were included in the analysis|||Months||95% Confidence Interval|Mean
2672770|NCT01466881|Secondary|Overall Survival (OS)|Measure from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|Up to 2 years after registration|Only eligible patients were included in the analysis.|||Months||95% Confidence Interval|Median
2672771|NCT01466881|Primary|Objective Response Rate (Complete Responses (CR) + Partial Responses (PR))|Objective disease status is evaluated according to the 2007 revised Cheson et al. criteria. Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|Up to 1 year after registration|All eligible patients who started treatment were included in assessing response estimates.|||participants|||Number
2672772|NCT01466790|Secondary|Number of Participants With Viral Relapse|Viral relapse was defined as undetectable HCV RNA at the actual EOT and confirmed quantifiable HCV RNA (>= 25 IU/mL) during follow-up period.|During the Follow-up [Week 36 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.|||Participants|||Number
2672773|NCT01466790|Secondary|Number of Participants With Inadequate Virologic Response|Inadequate Virologic Response was defined as confirmed detectable HCV RNA at or after Week 8 and not meeting the viral breakthrough definition.|Week 8 and End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.|||Participants|||Number
2672774|NCT01466790|Secondary|Number of Participants With Viral Breakthrough|Viral breakthrough was defined as confirmed quantifiable HCV RNA after becoming less than (<) lower limit of quantification (LLOQ) or confirmed greater than (>) 1 log10 HCV RNA increase from the lowest level reached on 2 consecutive occasions.|Up to End of Treatment [Week 12 (for the arms treated for 12 weeks) or Week 24 (for the arms treated for 24 weeks)]|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.|||Participants|||Number
2672775|NCT01466790|Secondary|Number of Participants With a Sustained Virologic Response (SVR) at Week 48|Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at week 48.|Week 48|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.|||Participants|||Number
2672776|NCT01466790|Secondary|Number of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Planned End of Treatment (EOT)|Participants with HCV RNA undetectable at end of treatment and HCV RNA less than (<) 25 IU/mL (detectable or undetectable) at 24 weeks after the planned end of treatment.|Week 12 and 36 (for the arms treated for 12 weeks) or Week 24 and 48 (for the arms treated for 24 weeks)|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.|||Participants|||Number
2673023|NCT01464931|Secondary|Percent Change From Baseline in Serum C-Telopeptide Over Time||Baseline and Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113|Pharmacodynamic Analysis Set (all participants who received at least 1 dose of denosumab and from whom baseline and at least 1 postbaseline value was collected)|||percent change||Inter-Quartile Range|Median
2672777|NCT01466790|Secondary|Number of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Planned End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 4 weeks after the planned end of treatment.|Week 12 and 16 (for the arms treated for 12 weeks) or Week 24 and 28 (for the arms treated for 24 weeks)|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.|||Participants|||Number
2672778|NCT01466790|Primary|Number of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Planned End of Treatment (EOT)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the planned end of treatment.|Week 12 and 24 (for the arms treated for 12 weeks) or Week 24 and 36 (for the arms treated for 24 weeks)|Intention-to-treat (ITT) population included all randomized participants who took at least one dose of investigational drug.|||Participants|||Number
2672779|NCT01466764|Secondary|Total Length of Hospital Stay|Total length of hospital stay for patients enrolled in the study.|Up to approximately 5 days maximum (admittance to discharge)||||hours||Standard Deviation|Median
2672780|NCT01466764|Secondary|Assess Rates of Wound Dehiscence|Evaluation of the surgical wound for symptoms of wound dehiscence was made every day during hospitalization. Records from the first post-operative clinic visit were also evaluated for evidence of wound dehiscence.|Up to 72 hours following surgery plus 3 weeks follow-up||||Participants|||Count of Participants
2672781|NCT01466764|Secondary|Count of Participants With Venous Thrombosis After Surgery During Hospitalization|Evaluation of the surgical wound for symptoms of venous thrombosis was made every day during hospitalization. Records from the first post-operative clinic visit were also evaluated for evidence of venous thrombosis.|Up to 72 hours following surgery plus 3 weeks follow-up||||Participants|||Count of Participants
2672782|NCT01466764|Secondary|Count of Participants Experiencing Wound Infection in the Study From Surgery Till the Time of Discharge From the Hospital|Evaluation of the surgical wound for symptoms of wound infection was made every day during hospitalization. Records from the first post-operative clinic visit were also evaluated for evidence of wound infection.|Up to 72 hours following surgery plus 3 weeks follow-up||||Participants|||Count of Participants
2672783|NCT01466764|Secondary|Post-operative Pain Intensity|Pain was measured on Day 1 and day 2 following surgery using a VAS scale at rest and on stimulation with Visual Analog Scale (VAS) of 1-10 (1=no pain and 10=worst pain)|Up to 72 hours following surgery|Participants with available data were analyzed.|||units on a Visual Analog scale||Full Range|Mean
2672784|NCT01466764|Secondary|Number of Participants With Analgesic Consumption During the 72 Hours Following Surgery|"Analgesic consumption is reported as the count of participants receiving each analgesic type. Comparisons between the placebo and active drug groups were made at the conclusion of the study.~PCA/IV: Patient controlled Analgesia/ Intravenous"|Up to 72 hours following surgery||||Participants|||Count of Participants
2672785|NCT01466764|Primary|Concentration Levels of Inflammatory Mediators IL-1 Receptor Antagonist (IL-1ra) Present in Human Wounds Following Surgery With and Without the Use of Anakinra.|Tissue samples were collected at the surgical wound site at 3 time points during the 1st 72 hours following surgery. Tissue samples from subjects receiving placebo, and subjects receiving anakinra injections pre, and post op were analyzed for IL-1|Up to 72 hours following surgery|IL-1ra measurements were invalid due to cross-reaction with the assay platform.||||||
2672786|NCT01466751|Primary|Amygdala Blood Oxygenation-level Dependent Response (BOLD) Activation to Face Affect Identification During Emotional Conflict|"The degree of differential BOLD signal change (T2*-weighted contrast in a defined region of the brain as measured by functional magnetic resonance imaging) within each individual, averaged across trials, during facial affect identification (fear or happy) and induction of emotional conflict (when the emotion word FEAR or HAPPY was either congruent or incongruent with the facial expression). We examined the differential degree of amygdala BOLD signal change as a function of emotion type (fear or happy), congruency (congruent or incongruent), and hemisphere (left or right) at baseline and 3 months."|Baseline, 3 Months||||Percentage of BOLD signal change||Standard Deviation|Mean
2672787|NCT01466751|Primary|Reaction Time to Facial Affect Identification During Emotional Conflict|"A standardized set of facial emotions (fear and happy) were presented for a duration of about 1 second in quick succession (a new face every 3-5 seconds). Across each face was written an emotional word (FEAR or HAPPY), which could be either congruent or incongruent with the facial expression. The participant was instructed to identify the facial emotion as quickly as possible and ignore the overlaid emotion word. The outcome measure of interest was the average speed (across all trials presented) within which an individual could correctly identify the facial emotion as a function of time (pre or post-intervention), treatment arm (control or intervention), facial affect (fear or happy), and congruency of word and facial affect (congruent or incongruent)."|Baseline, 3-month|Participants who complete the protocol were included in the analysis.|||milliseconds||Standard Deviation|Mean
2672788|NCT01466673|Secondary|Change From Baseline in Body Weight at Month 6|Change from Baseline in body weight is the value at Month 6 minus value at Baseline.|Baseline and Month 6|"Safety population included all randomized participants who received at least one dose of study medication. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Kilograms||Standard Deviation|Mean
2672789|NCT01466673|Secondary|Change From Baseline in Blood Pressure (BP) at Month 6|Blood pressure is the pressure of blood flowing through blood vessels. Change from Baseline in blood pressure is the value at Month 6 minus value at Baseline.|Baseline and Month 6|"Safety population included all randomized participants who received at least one dose of study medication. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Millimeters of Mercury||Standard Deviation|Mean
2672913|NCT01466153|Secondary|Progression Free Survival (PFS)|PFS was measured from the start of treatment with study drug until the first documentation of disease progression or death due to any cause, whichever occurred first. Kaplan-Meier method was used for evaluation.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.|||Months||95% Confidence Interval|Median
2672790|NCT01466673|Secondary|Number of Participants With Treatment Response at the End-of-Therapy by Participant's Self-Assessment at Month 6|Participant's self-assessment at end-of-therapy was measured by using the self-assessment questionnaire which included 3 questions, about the rating of acne improvement since start of study; comparison of this acne treatment with the one used in past and the continuity of treatment on physician's prescription to evaluate efficacy and acceptability of the study medication. The score was graded at 4 parameters as excellent, better, no change and worse.|Month 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. N signifies those participants who were evaluated for this measure."|||Participants|||Number
2672791|NCT01466673|Secondary|Percentage of Participants Showing Treatment Response on the Investigator's Global Assessment at Month 6|Percentage of participants showing treatment response on the Investigator's global assessment was graded on a 5-point scale as 0=worse, 1=no change, 2=fair, 3=good, and 4=excellent.|Month 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. N signifies those participants who were evaluated for this measure."|||Percentage of participants|||Number
2672792|NCT01466673|Secondary|Percentage of Participants With Categorical Score for Sebum Assessment at Month 1, 3 and 6|Sebum assessment that is facial seborrhea (very oily skin) was assessed using sebutape strip on the forehead. Percentage of participants with facial seborrhea were assessed using categorical scores ranging from level 1 (lowest) to level 5 (highest). Highest level indicates worsening.|Baseline and Month 1, 3 and 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Percentage of Participants|||Number
2672793|NCT01466673|Secondary|Number of Participants Non-Compliant With Therapy|Compliance was assessed by transforming the data of forgotten tablets listed in the diary cards. Number of participants who forgot to take the drug was reported.|Month 1, 3 and 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Participants|||Number
2672794|NCT01466673|Secondary|Number of Participants With Abnormal Vaginal Blood Loss at Month 1, 3 and 6|Vaginal blood loss encompasses spotting and bleeding. Spotting is defined as a bleeding requiring no or at most one sanitary pad per day; however, bleeding requires two or more sanitary pads per day.|Month 1, 3 and 6|"Safety population included all randomized participants who received at least one dose of study medication. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Participants|||Number
2672795|NCT01466673|Primary|Change From Baseline in Total and Each Type of Acne Lesions Count at Month 6|Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 6. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.|Baseline and Month 6|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Lesions||Standard Deviation|Mean
2672796|NCT01466673|Primary|Change From Baseline in Total and Each Type of Acne Lesions Count at Month 3|Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 3. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.|Baseline and Month 3|"ITT population included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria. n signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively."|||Lesions||Standard Deviation|Mean
2672797|NCT01466673|Primary|Change From Baseline in Total and Each Type of Acne Lesions Count at Month 1|Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 1. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count.|Baseline and Month 1|Intent-to-treat population (ITT) included all randomized participants who received at least one dose of study medication and fulfilled all inclusion and exclusion criteria.|||Lesions||Standard Deviation|Mean
2672798|NCT01466660|Secondary|Health-related Quality of Life (Primary Analysis Cut-off Date, 21 August 2015)|"Health-related quality of life (HRQoL) measured using European Quality of life - 5 Dimensions (EQ-5D) score for United Kingdom (UK) and Belgium and European European Quality Visual Analogue Scale (EQ-VAS).~EQ-5D utility scores range from 0 (worst health) to 1 (full health).~EQ-VAS scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).~Results display the mean score up to 56 weeks."|Every 8 weeks, up to 56 weeks|All randomised subjects with health-related quality of life data.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2672799|NCT01466660|Secondary|Tumour Shrinkage (Main Overall Survival Analysis Cut-off Date, 08 April 2016)|Tumour shrinkage assessed by minimum sum of post-baseline target lesion diameters recorded after randomisation. A positive value shows a decrease in tumour size.|From first drug administration until last drug administration, up to 1482 days|Participants in the randomised set with tumour assessments.|||millimetre (mm)||95% Confidence Interval|Least Squares Mean
2672800|NCT01466660|Secondary|Duration of Disease Control|Duration of disease control defined as the time from randomisation to the time of progression or death, whichever occurred first (or date of censoring for progression free survival). For the final analysis (analysis cut-off date 12 April 2019) the status and date of disease progression were determined by investigator assessment.|From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days.|All participants in the randomised set with disease control, that is, with best overall response of complete response or partial response or stable disease.|||Months||95% Confidence Interval|Median
2672801|NCT01466660|Secondary|Disease Control|Percentage of participants with disease control which was defined as the number of participants with best overall response of complete response (CR) or partial response (PR) or stable disease (SD) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. divided by the total number of participants who received treatment. Per RECIST version 1.1. for target lesions and assessed by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions from baseline; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Responses of SD were only considered if they occur ≥42 days from date of randomisation. For the final analysis (analysis cut-off date 12 April 2019) disease control was determined by investigator assessment.|From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days.|Randomised set which included all patients randomised to receive treatment, whether treated or not.|||Percentage of participants||95% Confidence Interval|Number
2672802|NCT01466660|Secondary|Duration of Objective Response|Duration of objective response defined as the time of first objective response (best overall response of complete response or partial response) to the time of progression or death, whichever occurred first (or date of censoring for progression free survival). For the final analysis (analysis cut-off date 12 April 2019) objective response was determined by investigator assessment.|From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days.|Participants in the randomised set with objective response.|||Months||95% Confidence Interval|Median
2672803|NCT01466660|Secondary|Time to Objective Response|Number of participants with objective response (best overall response of complete response or partial response) to study treatment over time, cumulative number of participants is displayed. Time to objective response was defined as the time from randomisation to the first recorded objective response. For the final analysis (analysis cut-off date 12 April 2019) objective response was determined by investigator assessment.|From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days.|All participants in the randomised set with objective response.|||Participants|||Number
2672804|NCT01466660|Secondary|Objective Response Rate|Objective response rate (ORR) which was defined as the number of participants with best overall response of complete response (CR) or partial response (PR) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. divided by the total number of participants who received treatment. Per RECIST version 1.1. for target lesions and assessed by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions from baseline. For the final analysis (analysis cut-off date 12 April 2019) objective response was determined by investigator assessment.|From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days.|Randomised set which included all patients randomised to receive treatment, whether treated or not.|||Percentage of participants||95% Confidence Interval|Number
2672805|NCT01466660|Primary|Overall Survival|Overall survival (OS) which was defined as the time from the date of randomisation to the date of death. Participants for whom there is no evidence of death at the time of the analysis will be censored at the date that they were last known to be alive.|From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on death, up to 2465 days.|Randomised set which included all patients randomised to receive treatment, whether treated or not.|||Months||95% Confidence Interval|Median
2672806|NCT01466660|Primary|Time to Treatment Failure (TTF) (Main Overall Survival Analysis Cut-off Date, 08 April 2016)|Time to Treatment Failure (TTF) which was the time from the date of randomisation to the date of i.e. permanent treatment discontinuation for any reason.|From first drug administration until last drug administration, up to 1482 days|Randomised set which included all patients randomised to receive treatment, whether treated or not.|||Months||95% Confidence Interval|Median
2672807|NCT01466660|Primary|Progression-free Survival|Progression-free survival (PFS) defined as the time from date of randomisation to date of disease progression, or date of death if a patient died earlier. Participants with no event (Disease progression (PD) or death) were censored. PD was primarily evaluated for the primary analysis by an independent central imaging review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Per RECIST version 1.1. for target lesions and assessed by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI): PD, At least a 20% increase in the sum of the longest diameter (SoD) of target lesions taking as reference the smallest SoD of target lesions recorded since the treatment started, together with an absolute increase in the SoD of target lesions of at least 5 millimetre (mm) or the appearance of one or more new lesions. For the final analysis (analysis cut-off date 12 April 2019) status and date of PD were determined by investigator assessment.|From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days.|Randomised set which included all patients randomised to receive treatment, whether treated or not.|||Months||95% Confidence Interval|Median
2672808|NCT01466595|Secondary|Primary Adverse Events|Primary adverse events include all SAEs, defined according to ICH guidelines and targeted protocol events (grade 2 or higher signs and symptoms, grade 2 or higher laboratory abnormality, all diagnoses identified by the ACTG criteria for clinical events, and all events that led to a change in treatment regardless of grade).|from study enrollment until study completion at 12 weeks||||participants|||Number
2672809|NCT01466595|Secondary|Change in CD4 Count From Week 4 to Week 12|Change in total CD4 T-cell count from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||cells/mm3||Inter-Quartile Range|Median
2672810|NCT01466595|Secondary|Change in CD38+ of CD8+ MFI From Week 4 to Week 12|"Change in CD38+ of CD8+ median fluorescence intensity (MFI) from week 4 to week 12.~MFI measures the shift in fluorescence intensity of a population of cells. MFI values are based on control to demonstrate an increase or decrease in expression of the marker. MFI in this study was automatically calculated in FlowJo. The median is the relative intensity value below which 50% of the events are found. MFI is an arbitrary unit of relative intensity."|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||MFI (relative intensity)||Inter-Quartile Range|Median
2672811|NCT01466595|Secondary|Change in CD4 Activation Percent From Week 4 to Week 12|Change in CD4 activation percent co-expressing HLA-DR and CD38 from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||percentage HLA-DR+/CD38+ of CD4+||Inter-Quartile Range|Median
2672812|NCT01466595|Secondary|Change in %Ki67+ of CD8+ From Week 4 to Week 12|Change in advanced flow percent Ki67+ of CD8+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12|||percentage Ki67+ of CD8+||Inter-Quartile Range|Median
2672813|NCT01466595|Secondary|Change in %Ki67+ of CD4+ From Week 4 to Week 12|Change in advanced flow percent Ki67+ of CD4+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12|||percentage Ki67+ of CD4+||Inter-Quartile Range|Median
2672814|NCT01466595|Secondary|Change in %CD38+ of CD8+ From Week 4 to Week 12|Change in advanced flow percent CD38+ of CD8+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||percentage CD38+ of CD8+||Inter-Quartile Range|Median
2672815|NCT01466595|Secondary|Change in %CD38+ of CD4+ From Week 4 to Week 12|Change in advanced flow percent CD38+ of CD4+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12|||percentage CD38+ of CD4+||Inter-Quartile Range|Median
2672816|NCT01466595|Secondary|Change in Peripheral B7hi CD4+ T-cells From Week 4 to Week 12|Change in gut homing percent B7hi+ of CD4+ from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||percentage B7hi+ of CD4+||Inter-Quartile Range|Median
2672817|NCT01466595|Secondary|Change in sCD14 From Week 4 to Week 12|Change in soluble CD14 from week 4 to week 12|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||log10 ng/mL||Inter-Quartile Range|Median
2672818|NCT01466595|Secondary|Change in hsCRP From Week 4 to Week 12|Change in hsCRP from week 4 to week 12.|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||log10 ng/mL||Inter-Quartile Range|Median
2672819|NCT01466595|Secondary|Change in LPS From Week 4 to Week 12|Change in LPS from week 4 to week 12.|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||log10 pg/mL||Inter-Quartile Range|Median
2672820|NCT01466595|Secondary|Change in IL-6 From Week 4 to Week 12|Change in IL-6 from week 4 to week 12.|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||log10 pg/mL||Inter-Quartile Range|Median
2672821|NCT01466595|Secondary|Change in D-dimer From Week 4 to Week 12|D-dimer is a fibrin degradation product (FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis.|At weeks 4 and 12|This analysis is as-treated, limited to subjects who have data for week 4 and week 12, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||log10 ng/mL||Inter-Quartile Range|Median
2672822|NCT01466595|Secondary|Change in CD8+ T-cell Activation From Week 4 to Week 12|Change in CD8+ T-cell activation percent co-expressing HLA-DR and CD38 from week 4 to week 12|At weeks 4 and 12|This analysis is as-treated, limited to subjects who had data for both week 4 and week 12, and (for the rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 12.|||percentage HLA-DR+/CD38+ of CD8+||Inter-Quartile Range|Median
2672823|NCT01466595|Secondary|Change in CD4 Count From Week 4 to Week 8|Change in total CD4 T-cell count from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||cells/mm3||Inter-Quartile Range|Median
2672824|NCT01466595|Secondary|Change in CD38+ of CD8+ MFI From Week 4 to Week 8|"Change in CD38+ of CD8+ median fluorescence intensity (MFI) from week 4 to week 8.~MFI measures the shift in fluorescence intensity of a population of cells. MFI values are based on control to demonstrate an increase or decrease in expression of the marker. MFI in this study was automatically calculated in FlowJo. The median is the relative intensity value below which 50% of the events are found. MFI is an arbitrary unit of relative intensity."|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||MFI (relative intensity)||Inter-Quartile Range|Median
2672825|NCT01466595|Secondary|Change in CD4 Activation Percent From Week 4 to Week 8|Change in CD4 activation percent co-expressing HLA-DR and CD38 from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||percentage HLA-DR+/CD38+ of CD4+||Inter-Quartile Range|Median
2672826|NCT01466595|Secondary|Change in %Ki67+ of CD8+ From Week 4 to Week 8|Change in advanced flow percent Ki67+ of CD8+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||percentage Ki67+ of CD8+||Inter-Quartile Range|Median
2672827|NCT01466595|Secondary|Change in %Ki67+ of CD4+ From Week 4 to Week 8|Change in advanced flow percent Ki67+ of CD4+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||percentage Ki67+ of CD4+||Inter-Quartile Range|Median
2672828|NCT01466595|Secondary|Change in %CD38+ of CD8+ From Week 4 to Week 8|Change in advanced flow percent CD38+ of CD8+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||percentage CD38+ of CD8+||Inter-Quartile Range|Median
2672829|NCT01466595|Secondary|Change in %CD38+ of CD4+ From Week 4 to Week 8|Change in advanced flow percent CD38+ of CD4+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||percentage CD38+ of CD4+||Inter-Quartile Range|Median
2672830|NCT01466595|Secondary|Change in Peripheral B7hi CD4+ T-cells From Week 4 to Week 8|Change in gut homing percent B7hi+ of CD4+ from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||percentage B7hi+ of CD4+||Inter-Quartile Range|Median
2672831|NCT01466595|Secondary|Change in sCD14 From Week 4 to Week 8|Change in soluble CD14 from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||log10 ng/mL||Inter-Quartile Range|Median
2672832|NCT01466595|Secondary|Change in hsCRP From Week 4 to Week 8|Change in hsCRP from week 4 to week 8.|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||log10 ng/mL||Inter-Quartile Range|Median
2672833|NCT01466595|Secondary|Change in LPS From Week 4 to Week 8|Change in LPS from week 4 to week 8.|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||log10 pg/mL||Inter-Quartile Range|Median
2672834|NCT01466595|Secondary|Change in IL-6 From Week 4 to Week 8|Change in IL-6 from week 4 to week 8.|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||log10 pg/mL||Inter-Quartile Range|Median
2672835|NCT01466595|Secondary|Change in D-dimer From Week 4 to Week 8|D-dimer is a fibrin degradation product (FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis.|At weeks 4 and 8|This analysis is as-treated, limited to subjects who have data for week 4 and week 8, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8|||log10 ng/mL||Inter-Quartile Range|Median
2672836|NCT01466595|Secondary|Change in CD8+ T-cell Activation From Week 4 to Week 8|Change in CD8+ T-cell activation percent co-expressing HLA-DR and CD38 from week 4 to week 8|At weeks 4 and 8|This analysis is as-treated, limited to subjects who had data for both week 4 and week 8, and (for the rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure prior to week 8.|||percentage HLA-DR+/CD38+ of CD8+||Inter-Quartile Range|Median
2672837|NCT01466595|Secondary|Change in CD4 Count From Baseline to Week 4|Change in total CD4 T-cell from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||cells/mm3||Inter-Quartile Range|Median
2672838|NCT01466595|Secondary|Change in CD38+ of CD8+ MFI From Baseline to Week 4|"Change in CD38+ of CD8+ MFI (Median Fluorescence Intensity) from baseline to week 4, where baseline value is the average of pre-entry and entry.~MFI measures the shift in fluorescence intensity of a population of cells. MFI values are based on control to demonstrate an increase or decrease in expression of the marker. MFI in this study was automatically calculated in FlowJo. The median is the relative intensity value below which 50% of the events are found. MFI is an arbitrary unit of relative intensity."|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||MFI (relative intensity)||Inter-Quartile Range|Median
2672839|NCT01466595|Secondary|Change in %HLA-DR+/CD38+ of CD4+ From Baseline to Week 4|Change in CD4 activation percent co-expressing HLA-DR and CD38 from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||percentage HLA-DR+/CD38+ of CD4+||Inter-Quartile Range|Median
2672840|NCT01466595|Secondary|Change in %Ki67+ of CD8+ From Baseline to Week 4|Change in advanced flow percent Ki67+ of CD8+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||percentage Ki67+ of CD8+||Inter-Quartile Range|Median
2672841|NCT01466595|Secondary|Change in %Ki67+ of CD4+ From Baseline to Week 4|Change in advanced flow percent Ki67+ of CD4+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||percentage Ki67+ of CD4+||Inter-Quartile Range|Median
2672842|NCT01466595|Secondary|Change in %CD38+ of CD8+ From Baseline to Week 4|Change in advanced flow percent CD38+ of CD8+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||percentage CD38+ of CD8+||Inter-Quartile Range|Median
2672843|NCT01466595|Secondary|Change in %CD38+ of CD4+ From Baseline to Week 4|Change in advanced flow percent CD38+ of CD4+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||percentage CD38+ of CD4+||Inter-Quartile Range|Median
2672844|NCT01466595|Secondary|Change in Peripheral B7hi CD4+ T-cell From Baseline to Week 4|Change in gut-homing percent B7hi+ of CD4+ from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||percentage B7hi+ of CD4+||Inter-Quartile Range|Median
2672845|NCT01466595|Secondary|Change in sCD14 From Baseline to Week 4|Change in soluble CD14 (sCD14) from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||log10 ng/mL||Inter-Quartile Range|Median
2672846|NCT01466595|Secondary|Change in hsCRP From Baseline to Week 4|Change in High Sensitivity C-reactive Protein (Hs-CRP) from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||log10 ng/mL||Inter-Quartile Range|Median
2672847|NCT01466595|Secondary|Change in LPS From Baseline to Week 4|Change in Lipopolysaccharide (LPS) from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||log10 pg/mL||Inter-Quartile Range|Median
2672848|NCT01466595|Secondary|Change in IL-6 From Baseline to Week 4|Change in Interleukin (IL)-6 from baseline to week 4, where baseline value is the average of pre-entry and entry|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||log10 pg/mL||Inter-Quartile Range|Median
2672849|NCT01466595|Secondary|Change in D-dimer From Baseline to Week 4|"Change in D-dimer from baseline to week 4, where baseline value is the average of pre-entry and entry.~D-dimer is a fibrin degradation product (FDP), a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis."|At baseline and 4 weeks|This analysis is as-treated, limited to subjects who have data for baseline and week 4, and (for the Rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change ART or use prohibited medications or have virologic failure during this time period.|||log10 ng/mL||Inter-Quartile Range|Median
2672850|NCT01466595|Primary|Change in CD8+ T-cell Activation From Baseline to Week 4|Change in CD8+ T-cell activation percent co-expressing HLA-DR and CD38 from baseline to week 4, where the baseline value is the average of pre-entry and entry values.|At baseline and 4 weeks|The primary analysis is as-treated, limited to subjects who had data for both baseline and week 4, and (for the rifaximin arm) remain on study treatment through week 4 (allowing less than or equal to 6 missed doses), and did not change antiretroviral therapy (ART) or use prohibited medications or have virologic failure during this time period.|||percentage HLA-DR+/CD38+ of CD8+||Inter-Quartile Range|Median
2672851|NCT01466491|Secondary|Pain Scores Throughout Procedure at Various Time Points|"Distance (mm) from the left of the 100 mm Visual Analog Scale (VAS anchors: 0=none, 100 mm= worst imaginable) recorded at various points throughout procedure:~prior to medication (baseline)~after speculum insertion~with placement of PCB~with cervical dilation~with aspiration~30 minutes post-operatively"|up to several hours||||mm||Standard Error|Mean
2672852|NCT01466491|Primary|Patient Perception of Pain|To determine whether varying paracervical block techniques affect patient perception of pain. Pain is measured as mm distance from the left of the 100-mm visual analogue (VAS) scale with the anchors 0 = none, 100 mm = worst imaginable (reflecting magnitude of pain) and recorded immediately after completion of cervical dilation.|after completion of cervical dilation||||mm||Standard Deviation|Mean
2672853|NCT01466387|Secondary|Number of Subjects With Adverse Events of Special Interest After Any Vaccination of Japanese Encephalitis and Rabies Virus Vaccines Given Concomitantly With MenACWY-CRM197 or Alone|In addition to the AEs and SAEs. Additional AESI were collected from day 1 to day 57 postvaccination in subjects after the vaccination of Japanese encephalitis and rabies virus vaccines given concomitantly with MenACWY-CRM197 or alone.|day 1 to day 57 post last vaccination|Analysis was done on the safety data set, i.e. the subjects in the exposed population who provided postvaccination safety data.|||subjects|||Number
2672854|NCT01466387|Secondary|Percentages of Subjects With Anti-rabies Virus Concentrations ≥ 0.5 IU/mL, 28 Days After the Last Vaccination of Rabies Virus Vaccine Concomitantly Either With Japanese Encephalitis or With Japanese Encephalitis and MenACWY-CRM197|"Immunogenicity was measured as the percentages of subjects who achieved seroprotection of anti-rabies virus antibody concentrations 28 days after vaccination of the third dose of rabies virus vaccine, when administered alone or concomitantly either with Japanese encephalitis or with Japanese encephalitis and MenACWY-CRM197 vaccines.~Seroprotection is defined as percentages of subjects who achieved anti-rabies virus antibody concentrations ≥ 0.5 IU/mL on day 57."|Baseline and 1 month post last vaccination (day 57).|The analysis was done on the MITT data set.|||Percentages of subjects||95% Confidence Interval|Number
2672855|NCT01466387|Secondary|Geometric Mean Rabies Virus Neutralizing Antibody Concentration 28 Days After the Last Vaccination Of Rabies Virus Vaccine Concomitantly Either With Japanese Encephalitis or With Japanese Encephalitis And MenACWY-CRM197|The immunogenicity was assessed in rabies virus vaccine as measured by geometric mean rabies virus neutralizing antibody concentration, 28 days after vaccination of the third dose, when administered alone or concomitantly either with Japanese encephalitis vaccine or with Japanese Encephalitis and MenACWY-CRM197 vaccines.|Baseline and 1 month post last vaccination (day 57).|The analysis was done on the MITT data set.|||IU/mL||95% Confidence Interval|Geometric Mean
2672856|NCT01466387|Secondary|Seroresponse Rate for Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone|"Immunogenicity was assessed by seroresponse rates as measured by human serum bactericidal activity (hSBA) titers for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with Japanese encephalitis and rabies virus vaccines or alone.~Seroresponse is defined as a subject with a baseline hSBA titer < 1:4, seroresponse was defined as a post-vaccination hSBA titer ≥ 1:8; for a subject with a baseline hSBA titer ≥ 1:4, seroresponse was defined as a postvaccination hSBA titer of at least 4 times the baseline."|1 month post last vaccination (day 29 or day 57)|The analysis was done on the MITT data set.|||Percentages of subjects||95% Confidence Interval|Number
2672857|NCT01466387|Secondary|Geometric Mean hSBA Titers for Meningococcal Serogroups A,C,W,Y 28 Days After the Vaccination of MenACWY-CRM197 Given Concomitantly With Japanese Encephalitis and Rabies Virus Vaccines or Alone|Immunogenicity was measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with Japanese encephalitis and rabies virus vaccines or alone.|Baseline and 1 month post last vaccination (day 29 or day 57).|The analysis was done on the MITT data set.|||titers||95% Confidence Interval|Geometric Mean
2672858|NCT01466387|Secondary|Seroresponse Rate For Meningococcal Serogroups A,C,W,Y 28 Days After Vaccination of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide and Yellow Fever Vaccines or Alone|"Immunogenicity was assessed by seroresponse rates as measured by human serum bactericidal activity (hSBA) titers for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with typhoid Vi polysaccharide and yellow fever vaccines or alone.~Seroresponse is defined as a postvaccination hSBA titer ≥1:8; for a subject with a baseline hSBA titer ≥1:4, seroresponse is defined as a postvaccination hSBA titer of at least four times the baseline."|1 month postvaccination (day 29)|The analysis was done on the MITT data set.|||Percentages of subjects||95% Confidence Interval|Number
2672859|NCT01466387|Secondary|Geometric Mean hSBA Titers For Meningococcal Serogroups A,C,W,Y 28 Days After The Vaccination Of MenACWY-CRM197 Given Concomitantly With Typhoid Vi Polysaccharide And Yellow Fever Vaccines Alone|Immunogenicity was assessed by Serum Bactericidal Assay using human complement (hSBA) geometric mean titers (GMTs) for meningococcal serogroups A,C,W,Y 28 days after administration of MenACWY-CRM197 given concomitantly with typhoid Vi polysaccharide and yellow fever vaccines or alone.|Baseline and 1 month postvaccination (day 29).|Analysis was done on the MITT data set.|||titers||95% Confidence Interval|Geometric Mean
2672869|NCT01466361|Primary|Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.|Baseline, 3 minutes and 15 minutes post-treatment|ITT population: All randomized participants who had at least one cravings assessment measurement post dose.|||Score on a scale||Standard Error|Least Squares Mean
2672860|NCT01466387|Secondary|Percentages Of Subjects With Anti-Rabies Virus Antibody Concentrations ≥ 0.5 IU/mL 28 Days After the Vaccination Of The Last Doses Of Japanese Encephalitis And Rabies Virus, Given Concomitantly With MenACWY-CRM197 Or Alone|"Immunogenicity was assessed as the percentages of subjects who achieved seroprotection as measured by neutralization test for anti-rabies neutralizing antibody titers, 28 days after administration of the second dose of Japanese encephalitis virus vaccine and 28 days after the vaccination of third dose of rabies virus vaccine, given alone or concomitantly with MenACWY-CRM197.~Seroprotection is defined as a subject with a baseline hSBA titer < 1:4, seroresponse was defined as a post-vaccination hSBA titer ≥ 1:8; for a subject with a baseline hSBA titer ≥ 1:4, seroresponse was defined as a post-vaccination hSBA titer of at least 4 times the baseline."|Baseline and 1 month post last vaccination (day 57).|Analysis was done on the MITT data set.|||Percentages of subjects||95% Confidence Interval|Number
2672861|NCT01466387|Secondary|Percentages Of Subjects With Anti-JE Neutralizing Antibody Titers ≥ 1/10, 28 Days After The Vaccination Of The Last Doses Of Japanese Encephalitis And Rabies, Given Concomitantly With MenACWY-CRM197 Or Alone|"Immunogenicity was measured as the percentages of subjects who achieved seroprotection as measured by neutralization test for anti-Japanese encephalitis neutralizing antibody titers, 28 days after administration of the second dose of Japanese encephalitis virus vaccine and 28 days after the vaccination of third dose of rabies virus vaccine, given alone or concomitantly with MenACWY-CRM197.~Seroprotection is defined as percentages of subjects who achieved anti-JE neutralizing titers ≥ 1/10 on Day 57."|Baseline and 1 month post last vaccination (day 57).|The analysis was done on the MITT data set.|||Percentages of subects||95% Confidence Interval|Number
2672862|NCT01466387|Secondary|Percentages Of Subjects With Anti-YF Neutralizing Antibody Titers ≥ 1/10, 28 Days After The Vaccination Of Typhoid Vi Polysaccharide And Yellow Fever, Concomitantly With MenACWY-CRM197 Or Given Alone|"Immunogenicity was assessed as the percentages of subjects who achieved seroprotection as measured by neutralization test for anti-YF neutralizing antibody titers after the vaccination of typhoid Vi polysaccharide and yellow fever, given alone or concomitantly with MenACWY-CRM197 on day 29.~Seroprotection is defined as percentages of subjects who achieved anti-YF neutralizing antibody titers ≥ 1/10 on day 29."|Baseline and 1 month postvaccination (day 29).|Analysis was done on the Modified-Intention to Treat (MITT) set, i.e. the subjects who provided evaluable serum samples whose assay results are available for at least one antigen on baseline and on at least one post-baseline visit.|||Percentages of subjects||95% Confidence Interval|Number
2672863|NCT01466387|Primary|Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration|Assessment was made to demonstrate the non-inferiority of the geometric mean anti-rabies virus neutralizing antibody concentrations, 28 days after the vaccination of the second dose of Japanese encephalitis vaccine and third dose of rabies virus vaccine given concomitantly with MenACWY-CRM197 or alone in healthy adults aged ≥18 years to ≤60 years.|Baseline and 1 month post last vaccination (day 57).|Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||IU/mL||95% Confidence Interval|Geometric Mean
2672864|NCT01466387|Primary|Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers|Assessment was made to demonstrate the non-inferiority of the geometric mean anti-Japanese encephalitis neutralizing antibody titers, 28 days after the vaccination of the second dose of Japanese Encephalitis vaccine and third dose of the rabies virus vaccine given concomitantly with MenACWY-CRM197 or alone in healthy adults aged ≥18 years to ≤60 years.|Baseline and 1 month post last vaccination (day 57).|Analysis was done on the PP set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||Titers||95% Confidence Interval|Geometric Mean
2672865|NCT01466387|Primary|Geometric Mean Anti-Yellow Fever Antibody Titer|Assessment was made to demonstrate the non-inferiority of the geometric mean anti-yellow fever antibody titers, 28 days after the vaccination of typhoid Vi polysaccharide (TF) and yellow fever (YF) vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone in healthy adults aged ≥18 years to ≤60 years.|Baseline and 1 month postvaccination (day 29).|Analysis was done on the per-protocol (PP) set, ie, the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||Titers||95% Confidence Interval|Geometric Mean
2672866|NCT01466387|Primary|Geometric Mean Anti-typhoid Vi Antibody Concentrations|Assessment was made to demonstrate the non-inferiority of the geometric mean anti-typhoid Vi antibody concentrations, 28 days after the vaccination of typhoid Vi polysaccharide (TF) and yellow fever (YF) vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone in healthy adults aged ≥18 years to ≤60 years.|Baseline and 1 month postvaccination (day 29).|Analysis was done on the per-protocol (PP) set, ie, the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||El.U/mL||95% Confidence Interval|Geometric Mean
2672867|NCT01466361|Secondary|Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)|"AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s.~SAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect."|Baseline, 0 minute, 60 minutes and 5 days post treatment|Safety population: All randomized participants who received the study treatments were considered evaluable for safety.|||participants|||Number
2672868|NCT01466361|Secondary|Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group|Responders were defined as participants with an increase of at least one point (on the 100 point VAS scale) from baseline prior to provoked craving paradigm (B1) to baseline post provoked craving paradigm (B2) on the average cravings score. Percentage of these responders was calculated to evaluate the provocation rate.|Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm||||percentage|||Number
2673024|NCT01464931|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to 12 Weeks (AUC0-12wks) After Dose 2|Estimated using the linear trapezoidal method.|Days 29 (predose), 36, 43, 57, 71, and 85|PK Parameter Analysis Set|||μg*day/mL||Standard Deviation|Mean
2672870|NCT01466361|Primary|Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers|Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.|Baseline, 1, 3, 5, 10 and 15 minutes post-treatment|Intent to treat (ITT) population: All randomized participants with at least one cravings assessment measurement post dose were analyzed. No data was imputed in case of dropouts or missing data.|||Score on a scale||Standard Error|Least Squares Mean
2672871|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test|Mood patterns was evaluated using the Mood, Alertness and Physical Sensation Scales (MAPSS) which comprised of 23 questions describing moods and physical sensations, on a 9-point scale anchored at the left hand end with 'not at all' and the right hand end with 'extremely'. For each question, '9' represented the 'best' score and '1' represented the 'worst' score. Mean score was calculated by summing the responses and dividing by the number of questions answered. MAPSS Questionnaire was further divided into three main clusters: Alertness; Anxiety and Headache as per the questions.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||Score on a scale||Standard Error|Mean
2672872|NCT01466348|Secondary|Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test|For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||Responses||Standard Error|Mean
2672873|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test|For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||msec||Standard Error|Mean
2672874|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test|For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||Valid responses||Standard Error|Mean
2672875|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||msec||Standard Error|Mean
2672876|NCT01466348|Secondary|Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||Responses||Standard Error|Mean
2672877|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test|Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||Valid responses||Standard Error|Mean
2672878|NCT01466348|Secondary|Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||Responses||Standard Error|Mean
2673025|NCT01464931|Secondary|Area Under the Serum Concentration-time Curve From Time 0 to 4 Weeks (AUC0-4wks) After Dose 1|Estimated using the linear trapezoidal method.|Days 1, 8, 15, and 29 (predose)|PK Parameter Analysis Set|||μg*day/mL||Standard Deviation|Mean
2672879|NCT01466348|Secondary|Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. Mean valid reaction time was determined.|Baseline, 30 minutes and up to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||milliseconds (msec)||Standard Error|Mean
2672880|NCT01466348|Secondary|Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.|Baseline to 60 minutes post treatment administration|ITT population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||Valid responses||Standard Deviation|Mean
2672881|NCT01466348|Primary|Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test|The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.|Baseline to 30 minutes post treatment administration|Intent-To-Treat (ITT) population: All randomized participants who were randomized and had at least one post-baseline efficacy evaluation.|||Valid responses||Standard Deviation|Mean
2672882|NCT01466270|Secondary|Fatigue|Fatigue is quantified by the FACIT-Fatigue scale. It consists of 13 questions answered on a 0 to 4 point scale. The fatigue score is the sum of the responses (some reverse scored) so that higher values represent less fatigue.|24 weeks|All randomized participants except two who did not provide any data.|||units on a scale||Standard Error|Least Squares Mean
2672883|NCT01466270|Secondary|HVLT-IR|Hopkins verbal learning test - immediate recall is the number of words (of 12) than can be remembers during three tries. The total score ranges from 0 to 36. Higher is better.|24 weeks|All randomized participants except two who did not provide any data.|||number of words recalled||Standard Error|Least Squares Mean
2672884|NCT01466270|Primary|Compliance|Compliance is the percentage of pills taken while on study (based on returned diaries)|24 weeks|Participants who returned pill diaries. Note that some participants did not return diaries so the numbers of participants for this analysis may not agree with the numbers for other analyses.|||percentage of pills||Full Range|Mean
2672885|NCT01466270|Primary|Retention|Retention is the percentage of participants who stay in the study for 24 weeks.|24 Weeks|All randomized patients|||percentage of participants||Standard Error|Mean
2672886|NCT01466192|Primary|Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)||After 24 weeks of follow-up||||percentage of subjects achieving SVR||95% Confidence Interval|Number
2672887|NCT01466179|Secondary|Best Response During the Core Study|"Complete Remission (CR):~bone marrow blasts ≤ 5%~no evidence of disease~full recovery of peripheral blood counts:~platelets > 100,000/μL, and~absolute neutrophil count (ANC) > 1,000/μL~Complete Remission With Partial Hematological Recovery (CRh*):~bone marrow blasts ≤ 5%~no evidence of disease~partial recovery of peripheral blood counts:~platelets > 50,000/μL, and~ANC > 500/μL~Blast Free Hypoplastic or Aplastic Bone Marrow:~bone marrow blasts ≤ 5%~no evidence of disease~insufficient recovery of peripheral counts: platelets ≤ 50,000/μL and/or ANC ≤ 500/μL~Partial Remission:~• bone marrow blasts 6% to 25% with at least a 50% reduction from Baseline."|From the first dose of blinatumomab until 30 days after the end of the last infusion during the core study, or until the data cut-off date of 10 October 2013; a maximum of 7.5 months.|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
2672888|NCT01466179|Secondary|Percentage of Participants With a Best Response of Blast Free Hypoplastic or Aplastic Bone Marrow Within 2 Cycles of Treatment|"Blast Free Hypoplastic or Aplastic Bone Marrow was defined as:~bone marrow blasts ≤ 5%~no evidence of disease~insufficient recovery of peripheral counts: platelets ≤ 50,000/μL and/or absolute neutrophil count (ANC) ≤ 500/μL"|Within the first 2 cycles of treatment, 12 weeks|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
2672889|NCT01466179|Secondary|Serum Cytokine Peak Levels|"The activation of immune effector cells was monitored by the measurement of peripheral blood cytokine levels including interleukin (IL)-2, IL-4, IL-6, IL-10, tumor necrosis factor (TNF)-α and interferon gamma (IFN)-γ using enzyme-linked immunosorbent assays or cytometric bead assays. The limit of detection of the assay (LOD) was 20 pg/mL and the limit of quantification (LOQ) was 125 pg/mL. Data below LOD were set to 10 pg/mL while data < LOQ and > LOD were reported as measured.~Serum IL-4 levels were below detection limit (< 20 pg/mL) at all time points in all participants studied."|Serum samples were collected on Days 1 and 8 at 2 hours and 6 hours after treatment start, and on Day 2 (24 hours) and Day 3 (48 hours) of each treatment cycle and on Days 9 and 10 after dose step.|Pharmacodynamic Data Set (PDS): All patients who received any infusion of blinatumomab and had at least one pharmacodynamic sample collected. N indicates the number of participants with available data at each time point.|||pg/mL||Standard Deviation|Mean
2672890|NCT01466179|Secondary|Serum Blinatumomab Concentration at Steady State|The steady state concentration of blinatumomab was summarized as the observed concentrations collected at least 10 hours after the start of the IV infusion or dose step for cycle 1 and cycle 2, respectively. Serum concentrations of blinatumomab were measured using a validated bioassay. The lower limit of quantitation (LLOQ) = 50.0 pg/mL.|Samples were taken before treatment start and on Days 3, 8, 10, 15, 22, and 29 after infusion start during Cycles 1 and 2.|Pharmacokinetic Data Set (PKS) defined as all patients who received any infusion of blinatumomab and had at least one PK sample collected unless significant protocol deviations affected the data analysis or if key dosing, dosing interruption or sampling information was missing.|||pg/mL||Standard Deviation|Mean
2672891|NCT01466179|Secondary|100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant|"The analysis of 100-day mortality after allogeneic HSCT was assessed for all participants who received an allogeneic HSCT while in remission (CR/CRh*) following treatment with blinatumomab. 100-day mortality after allogeneic HSCT was calculated relative to the date of allogeneic HSCT.~Patients alive were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive.~The 100-day mortality rate after allogeneic HSCT was defined as the percentage of patients having died up to 100 days after allogeneic HSCT estimated using the estimated time to death in percent calculated by Kaplan-Meier methods."|From the date of allogeneic HSCT until the data cut-off date of 10 October 2013; median observation time was 7.4 months.|Participants who received an allogeneic HSCT while in remission induced by blinatumomab treatment.|||percentage of participants||95% Confidence Interval|Number
2672892|NCT01466179|Secondary|Number of Participants With Treatment-emergent Adverse Events|"Adverse events (AEs) were evaluated for severity according to the the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4, as follows: Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death.~The investigator used medical judgment to determine if there was a causal relationship (ie, related, unrelated) between an adverse event and blinatumomab.~An AE was considered serious if it resulted in death, was life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant incapacity or substantial disruption to conduct normal life functions, is a congenital anomaly or birth defect or is a medically important condition.~Progressive disease was not an adverse event, per the protocol, unless it was more severe than expected for the patient. Therefore, many deaths due to progressive disease were not counted as adverse events."|From the start of the first infusion to 30 days after the end of the last infusion in the core study or from the start of the first retreatment cycle infusion to 30 days after the end of the last retreatment cycle, median treatment duration was 42.2 days.|Full analysis set (FAS), defined as all patients who received any infusion of blinatumomab.|||participants|||Number
2672893|NCT01466179|Secondary|Overall Survival|Overall survival was measured for all participants from the time the participant received the first treatment of blinatumomab until death due to any cause or the date of the last follow-up. Participants who did not die were censored on the last documented visit date or the date of the last phone contact when the patient was last known to have been alive. Overall survival was estimated using Kaplan-Meier methods. The median follow-up time with respect to overall survival was calculated by the reverse Kaplan Meier method.|Up to the data cut-off date of 10 October 2013; median observation time was 9.8 months.|Primary analysis set|||months||95% Confidence Interval|Median
2672894|NCT01466179|Secondary|Event-free Survival|"Event-free survival was calculated from the start date of blinatumomab infusion until the date of bone marrow aspiration at which hematological relapse was first detected, or the date of diagnosis on which the hematological or extramedullary relapse was documented or the date of start of any new therapy for ALL (excluding HSCT), or the date of death, whichever was earlier. Participants who did not achieve complete remission or complete remission with partial hematological recovery during the core study were evaluated as having an event on Day 1. Participants in remission who did not experience hematological relapse, did not receive a new therapy for ALL (excluding HSCT), and did not die were censored on the date of the last available bone marrow aspiration or on the last date of survival follow-up visit, whichever was later.~Event free survival was estimated using Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method."|Up to the data cut-off date of 10 October 2013; median observation time was 9.8 months.|Primary analysis set|||months||95% Confidence Interval|Median
2672895|NCT01466179|Secondary|Relapse-free Survival|"Relapse-free survival was assessed for participants who achieved a complete remission or complete remission with partial hematological recovery during the core study and was measured from the time the participant first achieved remission until first documented relapse or death due to any cause. Participants without a documented relapse (hematological or extramedullary) or who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission.~Relapse free survival was estimated using Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method."|Up to the data cut-off date of 10 October 2013; median observation time was 8.9 months.|Participants who reached complete remission or complete remission with partial hematological recovery during the core study|||months||95% Confidence Interval|Median
2672896|NCT01466179|Secondary|Percentage of Participants With a Best Response of Partial Remission Within 2 Cycles of Treatment|Partial Remission is defined as bone marrow blasts 6% to 25% with at least a 50% reduction from baseline.|Within the first 2 cycles of treatment, 12 weeks|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
2672897|NCT01466179|Secondary|Percentage of Participants With a Best Response of Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment|"Complete Remission With Partial Hematological Recovery was defined by the following criteria:~bone marrow blasts ≤ 5%~no evidence of disease~partial recovery of peripheral blood counts:~platelets > 50,000/μL, and~ANC > 500/μL."|Within the first 2 cycles of treatment, 12 weeks|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
2672898|NCT01466179|Secondary|Percentage of Participants With a Best Response of Complete Remission Within 2 Cycles of Treatment|"Complete Remission was defined by the following criteria:~bone marrow blasts ≤ 5%~no evidence of disease~full recovery of peripheral blood counts:~platelets > 100,000/μL, and~absolute neutrophil count (ANC) > 1,000/μL"|Within the first 2 cycles of treatment, 12 weeks|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
2672899|NCT01466179|Secondary|Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT) During Blinatumomab Induced Remission|Participants who were eligible for allogeneic HSCT were those who achieved remission (complete response or complete response with partial recovery of peripheral blood counts) after 2 cycles of blinatumomab treatment, and no further anti-leukemic medication was given before HSCT.|Up to the data cut-off date of 10 October 2013. Maximum duration on study was 17.8 months.|Participants who reached complete remission or complete remission with partial hematological recovery during the first 2 cycles of treatment.|||percentage of participants||95% Confidence Interval|Number
2674990|NCT01451398|Secondary|FEV1 Change From Baseline to Week 24|Forced Expiratory Volume in 1 second - change from baseline to week 24|Baseline to Week 24|Full analysis set for patients with data at both Baseline and at Week 24|||Liters||Standard Deviation|Mean
2672900|NCT01466179|Secondary|Time to Hematological Relapse (Duration of Response)|"Time to hematological relapse was measured for participants in remission during the core study (the time from the first infusion through 30 days after the last infusion), from the time the participant first achieved remission until first documented relapse or death due to disease progression. Participants without documented relapse (hematological or extramedullary) and who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death.~Hematological relapse is defined as:~proportion of blasts in bone marrow > 5% after documented CR/CRh* or~blasts in peripheral blood after documented CR/CRh*.~Time to hematological relapse was analyzed by Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method."|Up to the data cut-off date of 10 October 2013; median observation time was 8.0 months.|Participants who reached complete remission or complete remission with partial hematological recovery during the core study.|||months||95% Confidence Interval|Median
2672901|NCT01466179|Primary|Percentage of Participants With a Best Response of Complete Remission or Complete Remission With Only Partial Hematological Recovery Within 2 Cycles of Treatment|"Hematological assessments were performed from bone marrow biopsy samples. All hematological assessments of bone marrow were reviewed in a central reference laboratory.~Hematological remissions were defined by the following criteria:~Complete Remission (CR):~bone marrow blasts ≤ 5%~no evidence of disease~full recovery of peripheral blood counts:~platelets > 100,000/μL, and~absolute neutrophil count (ANC) > 1,000/μL~Complete Remission With Partial Hematological Recovery (CRh*):~bone marrow blasts ≤ 5%~no evidence of disease~partial recovery of peripheral blood counts:~platelets > 50,000/μL, and~ANC > 500/μL."|Within the first 2 cycles of treatment, 12 weeks|The Primary Analysis Set (PAS), defined as participants from the first 3 stages of the study who received any infusion of blinatumomab.|||percentage of participants||95% Confidence Interval|Number
2672902|NCT01466166|Secondary|Number of Palpable Tophi Over Time|Gout tophi are nodular deposits of urate crystals and inflammatory cells in joints, soft tissues, bones, and in some organs.|Baseline and weeks 24 and 52|Enrolled participants with available data at baseline and each time point.|||tophi||Standard Deviation|Mean
2672903|NCT01466166|Secondary|Number of Tender Joints Over Time||Baseline and weeks 24 and 52|Enrolled participants with available data at baseline and each time point.|||tender joints||Standard Deviation|Mean
2672904|NCT01466166|Secondary|Number of Swollen Joints Over Time||Baseline and weeks 24 and 52|Enrolled participants with available data at baseline and each time point.|||swollen joints||Standard Deviation|Mean
2672905|NCT01466166|Secondary|Change From Baseline in Number of Gout Flares|The number of gout flares occurring in the 2 weeks prior to each visit. Baseline number of flares was calculated as the average number of flares that occurred in the 6-month baseline period divided by 12 weeks.|Baseline, week 24 and week 48|Enrolled participants with a value at baseline and each time point|||flares||Standard Deviation|Mean
2672906|NCT01466166|Secondary|Percentage of Participants With Normalization of Serum Uric Acid at Week 24 and Week 52|Normalization of serum uric acid was defined as serum uric acid value less than 6 mg/dL.|Week 24 and week 52|Participants with missing values at week 24 or 52 are counted as not achieving normalization|||percentage of participants|||Number
2672907|NCT01466166|Primary|Number of Participants With Immune Complex-related Events|Immune complex-related events were defined as any presumptive immune complex-related disorders that were confirmed by an appropriate investigation of the event and of complement markers (C3 and C4 levels). Clinical manifestations could have included skin rash, arthralgia, arthritis, proteinuria, serum sickness, and cryoglobulinemia.|From first dose of study drug to the end of the 12-week follow-up period (63 weeks).|All enrolled participants|||Participants|||Count of Participants
2672908|NCT01466166|Primary|Number of Participants With Anaphylaxis|"Anaphylaxis was defined using the National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network (NIAID/FAAN) criteria: Acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal tissue, or both (e.g., generalized hives; pruritus or flushing; swollen lips, tongue, or uvula), and at least 1 of the following:~Respiratory compromise (e.g., dyspnea, wheeze-bronchospasm, stridor, reduced peak expiratory flow, hypoxemia).~Reduced blood pressure (i.e., systolic blood pressure < 90 mm Hg or greater than 30% decrease from that patient's baseline) or associated symptoms of end-organ failure (e.g., hypotonia [collapse], syncope, incontinence)."|52 weeks|All enrolled participants|||Participants|||Count of Participants
2672909|NCT01466166|Primary|Number of Participants With Infusion Reactions|Infusion reactions were defined as adverse events (AEs) or clusters of events, not attributable to another cause that occurred during or within 2 hours after the infusion of pegloticase. Any other case that occurred outside of the 2-hour window was categorized per Investigator discretion.|52 weeks|The intent-to-treat population included all enrolled participants|||Participants|||Count of Participants
2672910|NCT01466153|Secondary|Terminal Half Life (t1/2) of MEDI-551|Terminal phase elimination half-life (T1/2) was the time required for half of the drug to be eliminated from the serum.|Pre-infusion and 1 hour post infusion on Days 2 and 8, Days 15 and 22 of cycle 1|The safety population includes all participants who received any investigational product. Participants whom PK samples were available were analyzed for this outcome measure.|||Day||Standard Deviation|Mean
2672911|NCT01466153|Secondary|Number of Participants Who Developed Detectable Anti-drug Antibodies (ADA)|A participant was considered ADA-positive across the study if they had a positive reading at any time point during the study.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|The safety population includes all participants who received any investigational product. Participants whom ADA samples were available were analyzed for this outcome measure.|||Participants|||Number
2672912|NCT01466153|Secondary|Overall Survival (OS)|OS was determined as the time from the start of treatment with study drug until death due to any cause. For participants who were alive at the end of the study or lost to follow-up, OS was censored on the last date when the participant was known be alive. Kaplan-Meier method was used for evaluation.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.|||Months||95% Confidence Interval|Number
2672914|NCT01466153|Secondary|Time to Disease Progression (TTP)|TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or - in the absence of any diagnosis of progressive disease - until the participant´s death.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.|||Months||95% Confidence Interval|Median
2672915|NCT01466153|Secondary|Time to Response|Time to response was evaluated using the Kaplan-Meier method.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.|||Months||95% Confidence Interval|Median
2672916|NCT01466153|Secondary|Minimal Residual Disease Negative Complete Response (CR) Rate|The MRD-negative CR rate was defined as the percentage of participants who achieved CR and became MRD-negative as determined by flow cytometry. CR as per International Working Group (IWG) was complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.|||Percentage of Participants||95% Confidence Interval|Number
2672917|NCT01466153|Secondary|Complete Response Rate|Complete response was as per IWG was the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.|||Percentage of Participants||95% Confidence Interval|Number
2672918|NCT01466153|Secondary|Number of Participants With Abnormal Vital Signs and Electrocardiogram Reported as AEs|AEs observed in participants with clinically significant ECG abnormalities were assessed.|From time of consent to 90 days post last dose|The safety population includes all participants who received any investigational product.|||Participants|||Number
2672919|NCT01466153|Secondary|Number of Participants With Abnormal Clinical Laboratory Parameters Reported as AEs|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Laboratory evaluations (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.|From time of consent to 90 days post last dose|The safety population includes all participants who received any investigational product.|||Participants|||Number
2672920|NCT01466153|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs)|An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug (MEDI-551). A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 90 that were absent before treatment or that worsened relative to pre-treatment state. An AESIs was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. Treatment emergent AESIs were collected from the time of dosing through Day 90 after the last dose of study drug.Hepatic function abnormality and infusion reactions resulting in discontinuation were considered as AESIs.|From time of consent to 90 days post last dose|The safety population includes all participants who received any investigational product.|||Participants|||Number
2672921|NCT01466153|Primary|Objective Response Rate|ORR, defined as the proportion of participants with complete response (CR) or partial response (PR) out of total number of participants. Responses were assessed by using National Cancer Institute - Working Group guidelines on CLL.|From treatment administration (Day 1) until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study (up to 24 months)|Intent-to-treat (ITT) population includes all participants who were randomized into the study.|||Percentage of Participants||95% Confidence Interval|Number
2672922|NCT01466127|Primary|Differential Skin Conductance Response (SCR) During the First Two Extinction Trials|Differences in skin conductance response (SCR) between the active vs. placebo conditions trials will be used to assess for the impact of oxytocin on fear acquisition and extinction. We will take a mean of the first two extinction trials to get this measure. Data was gathered in micro-Siemens and then underwent a square root transformation.|Day 2 of Conditioning (1 day post Day 1 of Conditioning)||||micro-Siemens (square rooted)||Standard Deviation|Mean
2672923|NCT01466075|Secondary|Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction|After reading the instructions for use, and without assistance from the study staff, subjects use the BGMS to perform basic tasks considered to be essential for the operation of the system.|1 hour|Blood data for three subjects were not considered evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. Remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available.|||participants|||Number
2672924|NCT01466075|Secondary|Percent of Venous Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results are compared with venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI venous plasma results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI venous plasma) or +/- 20% (>=75mg/dL YSI venous plasma).|1 hour|609 venous BG results(203 subjects x 3 test strip lots) were available. Three subjects did not have successful venipunctures so no blood obtained. BGMS testing was not performed with one subject's blood sample. Study staff tested each subject venous blood sample using 3 test strip lots.|||percentage of Blood Glucose Test Results|Participants||Number
2673574|NCT01460940|Secondary|Progression-free Survival in Patients With Previously Treated Hodgkin's Lymphoma Receiving Combined Lenalidomide and Panobinostat|Determined from the date of start of therapy to death from any cause or censored at the last date the patient is known to be alive|3-5 years||||months||95% Confidence Interval|Median
2672925|NCT01466075|Secondary|Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results are used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma).|1 hour|Blood data for three subjects were not evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. The remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available.|||percentage of Blood Glucose Test Results|Participants||Number
2672926|NCT01466075|Primary|Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using the Apollo Evolution Investigational Blood Glucose Monitoring System (BGMS). BGMS results are compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results are used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma). Site staff tested in parallel after subjects.|1 hour|Blood data for three subjects were not evaluable because the difference between the replicates of the reference YSI analyzer measurements exceeded the protocol defined criteria. Remaining 204 subjects each tested one of three test strip lots on the system. 204 (207-3) test results were available.|||percentage of Blood Glucose Test Results|Participants||Number
2672927|NCT01466062|Secondary|Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121|The values -, -/+, 1+, 2+, 3+, and 4+ represent a range from none (-) to highest (4+) presence of protein, glucose, and occult blood in the urine. Table presents the number of participants with each value. Those categories with 0 participants to report at either time point are not included in the table below.|Screening, Day 121 (30 days after the 4th dose)|All participants; n=number of participants with measurements at given time points.|||participants|||Number
2672928|NCT01466062|Secondary|Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121|Normal ranges for total bilirubin, BUN, creatinine, and CRP varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.|||mg/dL||Standard Deviation|Mean
2672929|NCT01466062|Secondary|Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121|Normal ranges for ALP, AST, and ALT varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.|||U/L||Standard Deviation|Mean
2672930|NCT01466062|Secondary|Hematology: Mean Baseline and Mean Change From Baseline in Red Blood Cells (RBC) and Platelet Count at Day 121|Normal ranges for RBC and platelet count varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.|||cells *10^4/µL||Standard Deviation|Mean
2672931|NCT01466062|Secondary|Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121|Normal ranges for WBC, neutrophils, eosinophils, basophils, lymphocytes, and monocytes varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants; n=number of participants with measurements at given time points.|||cells *10^3/µL||Standard Deviation|Mean
2672932|NCT01466062|Secondary|Hematology: Mean Baseline and Mean Change From Baseline in Hematocrit at Day 121|Normal range for hematocrit varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.|||percentage of red blood cells||Standard Deviation|Mean
2672933|NCT01466062|Secondary|Hematology: Mean Baseline and Mean Change From Baseline in Hemoglobin at Day 121|Normal range for hemoglobin varied by the monthly age of the participant.|Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.|||g/dL||Standard Deviation|Mean
2672934|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Body Weight at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.|||kilograms||Standard Deviation|Mean
2672935|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Pulse Rate at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.|||beats per minute||Standard Deviation|Mean
2672936|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Respiratory Rate at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.|||respirations per minute||Standard Deviation|Mean
2672937|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Body Temperature at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants with measurements at given time points.|||degrees Celcius||Standard Deviation|Mean
2672938|NCT01466062|Secondary|Mean Baseline and Mean Change From Baseline in Systolic/Diastolic Blood Pressure at Day 121||Baseline (Day 1), Day 121 (30 days after the 4th dose)|All participants; n= number of participants with measurements at given time points.|||mm Hg||Standard Deviation|Mean
2672939|NCT01466062|Secondary|Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs|An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.|From the first administration of palivizumab to 100 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|All participants|||participants|||Number
2672940|NCT01466062|Secondary|Duration of Required Treatment for Respiratory Syncytial Virus (RSV) Infection|Duration (days) of requirement for any of the investigated treatments (admission in the intensive care unit [ICU], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug.|From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|Number of participants who required any of the investigated treatments for RSV. Since no subject had a RSV infection from the first administration of palivizumab to 30 days after the administration of palivizumab, the number of participants analyzed was 0 for this measure.||||||
2672941|NCT01466062|Secondary|Duration of Hospitalization Caused by Respiratory Syncytial Virus (RSV) Infection|Number of days of hospitalization caused by RSV infection.|From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|Number of participants hospitalized. Since no subject had a RSV infection from the first administration of palivizumab to 30 days after the administration of palivizumab, the number of participants analyzed was 0 for this measure.||||||
2672942|NCT01466062|Secondary|Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection|Percentage of participants who required any of the investigated treatments (admission in the intensive care unit [ICU], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug.|From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|All participants|||percentage of participants||95% Confidence Interval|Number
2672943|NCT01466062|Secondary|Percentage of Participants Requiring Hospitalization For Respiratory Syncytial Virus (RSV) Infection||From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.|All participants|||percentage of participants||95% Confidence Interval|Number
2672944|NCT01466062|Primary|Serum Palivizumab Trough Concentrations at Day 1, Day 31, and Day 121|Serum trough concentrations of palivizumab were assessed at Screening, at Day 31 (30 days after the 1st dose) and Day 121 (30 days after the 4th dose).|Day 1 (Screening), Day 31, Day 121|All participants; n=number of non-missing observations.|||µg/mL||Standard Deviation|Mean
2672945|NCT01465997|Primary|Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years)|A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.|Up to 3.5 Years (Duration of the Treatment Phase)||||Participants|||Count of Participants
2672946|NCT01465997|Primary|Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years)|Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.|Up to 3.5 Years (Duration of the Treatment Phase)||||Participants|||Count of Participants
2672947|NCT01465997|Primary|Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years)|Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.|Up to 3.5 Years (Duration of the Treatment Phase)||||Participants|||Count of Participants
2672948|NCT01465958|Primary|Mean Trough of Serum Total IgG|Mean trough serum total IgG values were calculated for each subject for the IV Phase (IV #1 and IV #2) and the SC phase (SC Weeks #9 and #12, and End of Treatment/Early termination visit). Mean trough concentration values of serum total IgG during the IV and SC phases were calculated based on the IgG population (subjects who received any amount of study drug and had serum total IgG concentration data).|4 - 5 weeks of IV administration and 12 weeks for SC administration|The IgG Population was used to calculate the trough serum concentrations. The IgG population consisted of all subjects who received any amount of GAMUNEX-C and had any serum total IgG concentration data.|||mg/dL||Full Range|Mean
2672949|NCT01465958|Primary|Steady-state Area Under the Curve (AUC) for Serum Total Immunoglobulin (IgG)|Steady-state area under the curve (AUC): For the IV phase, the mean adjusted AUC was calculated for all 11 subjects, which included subjects on both 3 and 4 week intravenous (IV) dosing schedules and who had sufficient immunoglobulin G (IgG) data. For the SC phase, the mean AUC was calculated for 10 subjects on weekly subcutaneous (SC) administration and who had sufficient IgG data.|4 to 5 weeks for IV administration; 12 weeks for SC administration|The PK population included the subjects with the availability of sufficient pharmacokinetics (PK) data to calculate area under the curve (AUC) for either the IV or SC phases.|||h*mg/dL||Full Range|Mean
2672950|NCT01465802|Secondary|Mean Plasma Ctrough for PF-05199265 by Visit for Cohorts I, II and III|"Ctrough was the pre-dose plasma concentration of the dacomitinib metabolite PF-05199265 at steady state obtained from direct inspection of the data.~Number of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics."|Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.|Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection in Cohorts I, II and III.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2672979|NCT01465464|Primary|Overall Survival(OS)||The time from the date of enrollment to the date of death from any cause, assessed up to three years after randomizationof the last patient|"When approximately 50% of the targeted number of time to TACE discontinuation events were confirmed, interim analysis was performed by IDMC.~Because the Committee considered that significant results would no longer be obtained, the IDMC recommended to the Sponsor that the clinical trial would be discontinued, and the Sponsor stopped this trial."|||days||95% Confidence Interval|Median
2672951|NCT01465802|Secondary|Mean Plasma Trough Concentrations (Ctrough) for Dacomitinib by Visit for Cohorts I, II and III|"Ctrough was the pre-dose plasma concentration of dacomitinib at steady state obtained from direct inspection of the data.~Number of participants analyzed is the total number of participants in the treatment group in the indicated population, n is the number of participants contributing to the summary statistics."|Cohorts I to III: Pre-dose on Day 1 of Cycle 3 to 10.|Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection in Cohorts I, II and III.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2672952|NCT01465802|Secondary|Mean Apparent Clearance (CL/F) for Dacomitinib on Cycle 2 Day 1 for Cohort I|CL/F was calculated as dose/AUCtau.|Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose|"Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.~Number of participants analyzed is the number of participants contributing to the summary statistics."|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2672953|NCT01465802|Secondary|Median Tmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I|Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.|Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose|"Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.~Number of participants analyzed is the number of participants contributing to the summary statistics."|||hr||Full Range|Median
2672954|NCT01465802|Secondary|Mean Cmax for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I|Cmax was obtained from direct inspection of the data.|Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose|"Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.~Number of participants analyzed is the number of participants contributing to the summary statistics."|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2672955|NCT01465802|Secondary|Mean AUC From 0 to the End of the Dosing Interval (AUC0-tau) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 2 Day 1 for Cohort I|AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 24 hours. AUCtau was calculated by the linear/log trapezoidal method using a non-compartmental PK analysis.|Cycle 2 Day 1: pre-dose and at 2, 4, 6, and 24 hours post-dose|"Dose-Compliant participants only. Participants were considered dose-compliant when they received at least 14 consecutive doses at the same dose level right before sample collection.~Number of participants analyzed is the number of participants contributing to the summary statistics."|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2672956|NCT01465802|Primary|Median Time of Occurrence of Cmax (Tmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III|Tmax was obtained from direct inspection of the data as the time of first occurence of Cmax.|Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).|Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.|||hours (hr)||Full Range|Median
2672957|NCT01465802|Primary|Mean Maximum Observed Plasma Concentrations (Cmax) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III|Cmax was obtained from direct inspection of the data. ng/mL = nanograms per milliliter|Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).|Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2672958|NCT01465802|Primary|Mean Area Under the Plasma Concentration Time Curve From 0 to 24 Hours (AUC0-24) and From 0 to 120 Hours (AUC0-120) for Dacomitinib and Its Metabolite PF-05199265 on Cycle 1 Days 10 to 15 for Cohort III|"AUC0-24 is the area under the plasma concentration-time curve (AUC) from time 0 to 24 hours post-dose. AUC0-120 is the AUC from time 0 to 120 hours post-dose. AUC was calculated by the linear trapezoidal method using a non-compartmental pharmacokinetic (PK) analysis.~ng*hr/mL = nanogram hours per milliliter"|Cycle 1 Day 10: Pre-dose and 2, 4, 6, 24, 48, 72, 96, and 120 hours post-dose (the 120 hour sample was obtained on Day 15 pre-dose).|Dose-Compliant participants only. Participants were considered dose-compliant when they received all planned doses at the same dose level right before sample collection.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2672959|NCT01465802|Secondary|Percentage of Participants Receiving Any Concomitant Drug or Non-Drug Treatment for SDAEI, Diarrhea and Mucositis for Cohort I by Treatment Arm, Cohort II, and Cohort III|Medications used concomitantly for SDAEIs, diarrhea and mucositis were evaluated for all participants who received dacomitinib on a continuous basis with a preemptive prophylactic (Cohorts I and II) or as an interrupted dosing regimen (Cohort III).|Screening to the Post-Teatment Follow-Up Visit (at least 28 days and no more than 35 days after the end of dacomitinib treatment due to progression of disease, intolerance to dacomitinib treatment, or participant withdrawal)|As Treated Population|||Percentage of Participants|||Number
2672960|NCT01465802|Primary|Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) for Cohort II|"PROs of HRQoL and disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses bother. It includes 3 multi-item scales: symptoms, emotions & functioning. Individual scaled scores & total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if > 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if >75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.~Skindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit."|Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up|PRO Skindex Analysis Population|||Score on a scale||Standard Deviation|Mean
2673019|NCT01464996|Secondary|Cavosurface Margin Discoloration|Percentage of restorations scoring alfa. No discoloration is present anywhere on the margin between the restoration and the tooth structure.|18 months post-baseline||||% of restorations with alfa scores|Participants||Number
2672961|NCT01465802|Primary|Percentage of Participants With SDAEI (All Causality, Grade ≥2) in the First 8 Weeks of Treatment for Cohort II|"SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. AEs were graded for severity using the NCI-CTCAE, Version 4.0.~95% CI calculated using exact method based on binomial distribution."|First 8 Weeks of Treatment|Evaluable Population|||Percentage of Participants||95% Confidence Interval|Number
2672962|NCT01465802|Primary|Percentage of Participants With SDAEI (All Causality, All Grade) in the First 8 Weeks of Treatment for Cohort II|"SDAEI of all causality and all grades were evaluated in participants in Cohort II. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer.~95% CI calculated using exact method based on binomial distribution."|First 8 Weeks of Treatment|Evaluable Population|||Percentage of Participants||95% Confidence Interval|Number
2672963|NCT01465802|Primary|Mean Change From Baseline (Cycle 1 Day 1) Modified Oral Mucositis Daily Questionnaire (OMDQ) Scores (Mouth and Throat Soreness Categories and Scale, and Diarrhea Categories and Scale) for Cohort II|"Diarrhea severity was assessed using the modified-OMDQ. This questionnaire is comprised of 6 questions in total; however, only two items relate to diarrhea symptoms (item 5 and item 6). Symptoms scores were developed for both the full questionnaire and for the diarrhea-only questions for each completed survey. Mucositis questions were transformed to a score range of 0 to 10. Increasing OMDQ values are associated with greater symptom burden.~Modified OMDQ completion criteria were defined as completion of all 4 questions (questions 2, 4, 5 and 6).~M/T = mouth and throat."|Cycles 1, 2, 3, 4, 5, and 6, EoT and Follow-up|PRO Modified OMDQ Analysis Population; participants meeting primary endpoint analysis & modified OMDQ specific criteria: a) Modified OMDQ completion criteria for initial visit & end of Cycle 2 or EoT visit; b) Completion criteria for at least 5 of 6 visits between initial & end of Cycle 2 visit. n = number of participants completing scale.|||Score on a scale||Standard Deviation|Mean
2672964|NCT01465802|Primary|Percentage of Participants With Diarrhea AEs (All Causality, All Grade and Grade ≥2) in the First 8 Weeks of Treatment for Cohort II|"Diarrhea AEs of all causality, all grade and Grade ≥2 were evaluated in participants in Cohort II. AEs were graded for severity using the NCI-CTCAE, Version 4.0.~95% CI calculated using exact method based on binomial distribution."|First 8 Weeks of Treatment|Evaluable Population|||Percentage of Participants||95% Confidence Interval|Number
2672965|NCT01465802|Primary|Mean Change From Baseline (Cycle 1 Day 1) Skindex-16 Scale Scores (Total Score, Symptoms Score, Emotion Score, and Functioning Score) by Treatment Arm for Cohort I|"Patient Reported Outcomes (PROs) of Health Related Quality of Life (HRQoL) & disease/treatment-related symptoms were assessed using Dermatologic Survey (Skindex-16) that assesses bother. It includes 3 multi-item scales: symptoms, emotions & functioning. Individual scaled scores & total scores were determined. Skindex questions were transformed to a linear scale of 0 (never bothered) to 100 (always bothered). Subscale scores are an average of non-missing questions in a given scale if greater than (>) 75% of total subscale questions are non-missing. The Total Score is an average of all non-missing questions in the Skindex if >75% of total questions are non-missing. A negative change score represents a better quality of life. A change score of 10 points is considered clinically significant.~Skindex completion criteria were defined as completion of 3 out of 4 items for questions 1 to 4, 6 out of 7 items for questions 5 to 11, 4 out of 5 items for questions 12 to 16 for the visit."|First 8 Weeks of Treatment|PRO Skindex Analysis Population: participants that met primary endpoint analysis & Skindex specific criteria: a) Skindex completion criteria (as above) for initial visit & end of Cycle 2 or EoT visit; b) Skindex completion criteria for at least 5 of 6 visits between initial visit & end of Cycle 2 visit. n = number of participants completing scale.|||Score on a scale||Standard Deviation|Mean
2672966|NCT01465802|Primary|Percentage of Participants With SDAEI (All Causality, Grade Greater Than or Equal to [≥] 2) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I|"SDAEI of all causality and Grade ≥2 were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer. Adverse events (AEs) were graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 4.0).~95% CI calculated using exact method based on binomial distribution. After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 2 was not conducted in Cohort I Arm C."|First 8 Weeks of Treatment|Evaluable Population|||Percentage of Participants||95% Confidence Interval|Number
2672967|NCT01465802|Primary|Percentage of Participants With Select Dermatologic Adverse Events of Interest (SDAEI) (All Causality, All Grade) in the First 8 Weeks of Treatment by Treatment Arm for Cohort I|"SDAEI of all causality and all grades were evaluated in participants in Cohort I. These SDAEIs included dermatitis acneiform, dry skin, exfoliative rash, nail discoloration, nail disorder, paronychia, pruritus, rash, skin exfoliation, skin fissures, skin infection, skin laceration and skin ulcer.~95% confidence interval (CI) calculated using exact method based on binomial distribution.~After protocol amendment 1, Arm C was removed from Cohort I and enrollment to Arm C was terminated. Only 7 participants were enrolled in Cohort I Arm C as a result. Given the smaller sample size, analyse of Outcome Measure 1 was not conducted in Cohort I Arm C."|First 8 Weeks of Treatment|Evaluable Population - included all participants who received the study treatment assigned at enrollment, but did not discontinue dacomitinib treatment less than 6 weeks from first dosing due to either disease progression or death.|||Percentage of Participants||95% Confidence Interval|Number
2672968|NCT01465763|Secondary|Change From Baseline in Total Mayo Scores at Week 8|Change in total Mayo scores at Week 8 relative to Baseline was reported. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Baseline, Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2672969|NCT01465763|Secondary|Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8|Change in partial mayo scores at weeks 2, 4, 8 relative to baseline were reported. A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.|Baseline, Weeks 2, 4, 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Error|Least Squares Mean
2672970|NCT01465763|Secondary|Partial Mayo Scores|A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.|Baseline, Weeks 2, 4, 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2672971|NCT01465763|Secondary|Percentage of Participants With Deep Remission at Week 8|Deep remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
2672972|NCT01465763|Secondary|Percentage of Participants With Symptomatic Remission at Week 8|Symptomatic remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
2672973|NCT01465763|Secondary|Percentage of Participants With Clinical Remission at Week 8|Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
2672974|NCT01465763|Secondary|Percentage of Participants With Endoscopic Remission at Week 8|Endoscopic remission in participants was defined by Mayo endoscopic subscore of 0. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
2672975|NCT01465763|Secondary|Percentage of Participants Achieving Clinical Response at Week 8|Clinical response in participants was defined by a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
2672976|NCT01465763|Secondary|Percentage of Participants Achieving Mucosal Healing at Week 8|Mucosal healing in participants was defined by Mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.|Week 8|FAS included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
2672977|NCT01465763|Primary|Percentage of Participants With Remission at Week 8|Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.|Week 8|Full analysis set (FAS) included all participants randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
2672978|NCT01465464|Secondary|Time to Transcatheter Arterial Chemoembolization (TACE) Failure|"Patients should not receive additional TACE therapy in this study after meeting any of the following conditions, at the Investigator's discretion.~The patient develops an intra-hepatic lesion that is uncontrolled by serial TACE~Deterioration in arterial pathways to treat HCC that makes additional TACE impossible~Severe vascular invasion occurs that makes additional TACE impossible~Extra hepatic spread considered relevant to life expectancy that requires another treatment modality for HCC~Liver function at grade Child-Pugh class C lasting for 28 days"|The time from the date of enrollment to the date of event for TACE discontinuation, assessed up to three years after randomizationof the last patient|"When approximately 50% of the targeted number of time to TACE discontinuation events were confirmed, interim analysis was performed by IDMC.~Because the Committee considered that significant results would no longer be obtained, the IDMC recommended to the Sponsor that the clinical trial would be discontinued, and the Sponsor stopped this trial."|||days||95% Confidence Interval|Median
2672980|NCT01465412|Secondary|Cmax of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of preladenant calculated using free drug concentration.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.|||ng/mL||Full Range|Least Squares Mean
2672981|NCT01465412|Secondary|AUC 0-t of Preladenant Calculated Using Free Drug Concentration After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of preladenant calculated using free drug concentration.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.|||hr*ng/mL||Full Range|Least Squares Mean
2672982|NCT01465412|Secondary|Cmax of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of SCH 446637.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.|||ng/mL||Full Range|Least Squares Mean
2672983|NCT01465412|Secondary|AUC 0-t of Preladenant Metabolite SCH 446637 After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of SCH 446637.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.|||hr*ng/mL||Full Range|Least Squares Mean
2672984|NCT01465412|Secondary|Cmax of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of SCH 434748.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.|||ng/mL||Full Range|Least Squares Mean
2672985|NCT01465412|Secondary|AUC 0-t of Preladenant Metabolite SCH 434748 After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of SCH 434748.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.|||hr*ng/mL||Full Range|Least Squares Mean
2672986|NCT01465412|Primary|Maximum Observed Plasma Concentration (Cmax) of Preladenant After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the Cmax of preladenant.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.|||ng/mL||Full Range|Least Squares Mean
2672987|NCT01465412|Primary|Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUC 0-t) of Preladenant After a Single Dose of Preladenant|For healthy and HI participants blood samples were collected at pre-dose (0 hour) and at 0.50, 1, 2, 4, 6, 12, 16, 24, 30, 36, and 48 hours postdose. Blood samples were also collected for HI participants only at 60 and 72 hours postdose in order to determine the AUC 0-t of preladenant.|Pre-dose up to 72 hours postdose|All participants who received an oral dose of preladenant and for whom at least one pharmacokinetic parameter can be calculated for the treatment phase according to the protocol and who did not have any protocol deviation interfering with pharmacokinetics.|||hr*ng/mL||Full Range|Least Squares Mean
2672988|NCT01465386|Primary|Progression Free Survival (PFS)|Number of days from enrollment to recurrence of acute myeloid leukemia as determined by the reappearance of blasts in the blood or marrow|Up to 2 years|Patient who began maintenance treatment with bortezomib after induction of remission|||days|Participants|Full Range|Median
2672989|NCT01465347|Secondary|Number of Participants With Reduction in Tumor Size, According to Percentage of Tumor Reduction|The sum of the product of the diameters of the tumor (using recorded tumor diameter measurements made from brain MRI images) was used to express tumor size. Results were summarized for actual and percentage change from baseline. Individual subjects results were listed, including tumor volume and tumor response from independent reviewers. Investigator data were listed but not used in the analysis. Percent response (according to independent reviewer assessments) by percentage tumor reduction from tumor resection or definitive biopsy to the last MRI were summarized.|From Baseline to Week 110|Of the 56 modified ITT population (subjects in the TSC 18 dose group) tumor size data exist for 37 subjects. Four (4) tumor-bearing subjects at baseline MRI did not have any post-baseline MRIs. Fourteen (14) subjects had a complete resection before baseline.|||Participants|||Count of Participants
2673020|NCT01464996|Secondary|Color Match|Percentage of restorations that scored alfa. Restoration matches adjacent tooth structure in color, shade and translucency.|18 months post-baseline||||% of restorations with alfa scores|Participants||Number
2672990|NCT01465347|Secondary|Progression-Free Survival (PFS)|The PFS analyses were performed using the Kaplan-Meier estimate method. The PFS rates at 6, 12, 18 and 24 months were estimated. Median PFS values were calculated; a corresponding 95% confidence interval for each median value was determined using a log rank analysis. Time to disease progression (in months) was calculated as follows: date of event* or censoring - date of surgery or definitive biopsy / 30.4375; *event = first tumor progression or death.|6,12,18, 24 months|The analysis of PFS was performed in phase 2 only and included the modified ITT population which included 54 of the 56 subjects (98.2%) at the 2-year time point.|||percentage of participants||95% Confidence Interval|Number
2672991|NCT01465347|Primary|Overall Survival|Participants in phase 2 (18 dose group, 6 weeks treatment with TSC) were monitored for up to 3 years (last follow-up - February 16, 2016). Overall Survival (OS) was defined as the length of time from the date of tumor resection surgery or definitive biopsy to the date of death. The OS analyses were performed using the Kaplan-Meier estimate method. The OS rates at 6, 12, 18 and 24 months were estimated. Median OS values were calculated; a corresponding 95% confidence interval for each median value was determined using a log rank analysis. The length of OS (in months) was calculated as follows: date of death or censored - date of surgery or definitive biopsy / 30.4375.|6, 12, 18, 24 months|All participants who received any amount of TSC and at least 1 session of RT (modified ITT)|||participants||95% Confidence Interval|Number
2672992|NCT01465347|Primary|Dose Limiting Toxicities (DLTs)|Number of Participants in Phase 1 with Dose Limiting Toxicities (DLTs)|During phase 1|Dose limiting toxicities were only assessed for Phase 1 participants|||Participants|||Count of Participants
2672993|NCT01465334|Secondary|Number of Participants Completing Only 2 Cycles of Part A Treatment|Participants counted if only completed 2 cycles of Part A treatment per protocol.|Evaluated after 2 cycles/8 weeks of Part A therapy.||||participants|||Number
2672994|NCT01465334|Secondary|Number of Participants Completing Part A Treatment|Participants counted as completing Part A with either 2 or 4 cycles of treatment per protocol.|Evaluated up to 4 cycles/16 weeks.||||participants|||Number
2672995|NCT01465334|Secondary|3-year Overall Survival (OS) Probability|3-year OS is the probability of participants remaining alive at 3 years from study entry estimated using Kaplan-Meier methods.|Median survival follow-up was 45 months (range 31-58 months) in this study cohort.||||percentage probability||95% Confidence Interval|Number
2672996|NCT01465334|Secondary|3-Year Progression-Free Survival (PFS) Probability|3-year PFS is the probability of participants remaining alive and progression-free at 3 years from study entry estimated using Kaplan-Meier methods. Disease progression (PD) per International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008) is: the appearance of any new lesion (enlarged lymph node minimum >1.5 centimeters); an increase by 50% in greatest determined diameter of any previous site; an increase in the previously noted enlargement of the liver or spleen by 50% or more or the de novo appearance of hepatomegaly, splenomegaly; a 50% increase of blood lymphocytes (over baseline with level at least 5,000/microliter); occurrence of cytopenia secondary to CLL at least 3 months post treatment including a 50% or greater decrease from baseline in platelet count (or level <100,000/microliter) or a hemoglobin decrease of >2 grams/deciliter (or level <10 grams/deciliter); and transformation to a more aggressive histology.|Disease was evaluated on treatment after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C as well as off-treatment every 3 months up to 5 years.||||percentage probability||95% Confidence Interval|Number
2672997|NCT01465334|Secondary|Number of Participants With Treatment-Related Grades 1-3 Hyperglycemia During Part A Induction|Participants ever experiencing a grade 1-3 hyperglycemia event based on CTCAEv4 with treatment attribution of possible, probably or definite as reported on case report forms were counted.|Adverse Events (AEs) were collected weekly during cycle 1 Part A and then every other week for the duration of Part A (up to 16 weeks)||||participants|||Number
2672998|NCT01465334|Secondary|Transplant Rate|Percentage of participants eligible for allogeneic hematopoietic stem cell transplantation (alloHSCT) that are able and willing to proceed to alloHSCT.|Evaluated up to 36 cycles (approximately 2.75 years) of treatment (Parts A, B and C)||||percentage of participants||90% Confidence Interval|Number
2672999|NCT01465334|Secondary|Overall MRD Negative Rate|Overall MRD negative rate is the percentage of participants classified as MRD negative by four color flow cytometry. The assay has a sensitivity of 1 in 10,000 leukocytes.|MRD was assessed after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.||||percentage of participants||90% Confidence Interval|Number
2673000|NCT01465334|Secondary|Number of Participants With Overall CR|CR overall (induction and maintenance treatment) was based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. CR is absence of significant lymphadenopathy (nodes<1.5 centimeters in long axis diameter), hepatomegaly, splenomegaly as well as blood lymphocytes<4000/microliter, normocellular for age marrow with <30% lymphocytes, no B-lymphoid nodules and platelet>100,000/micro liter, hemoglobin>11 grams/deciliter, neutrophils>1500/microliter.|Disease was evaluated after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.||||participants|||Number
2673001|NCT01465334|Secondary|Overall Objective Response Rate (ORR)|Overall ORR is the percentage of participants achieving a minimum of partial response (PR) over induction and maintenance treatment based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. PR is a 50% or greater decrease of measured size of lymphadenopathy, hepatomegaly, splenomegaly as well as blood lymphocytes (over baseline), marrow infiltrate or B-lymphoid nodules and a 50% or greater increase from baseline in platelet count (or level >100,000/micro liter), hemoglobin (or level >11 grams/deciliter), neutrophils (or level >1500/microliter).|Disease was evaluated after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.||||percentage of participants||90% Confidence Interval|Number
2673021|NCT01464996|Primary|Retention|Overall retention of restorations|6 and 18 months post-baseline|what is reported here is the retention rate using the restoration as the unit of analysis|||percentage of restorations|Participants||Number
2673002|NCT01465334|Secondary|Number of Participants Achieving Induction Complete Response (CR)|CR over induction treatment was based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. CR is absence of significant lymphadenopathy (nodes<1.5 centimeters in long axis diameter), hepatomegaly, splenomegaly as well as blood lymphocytes<4000/microliter, normocellular for age marrow with <30% lymphocytes, no B-lymphoid nodules and platelet>100,000/micro liter, hemoglobin>11 grams/deciliter, neutrophils>1500/microliter.|Disease was evaluated after weeks 8 and 16 of Part A and at 12, 18 and 24 weeks during part B.||||participants|||Number
2673003|NCT01465334|Primary|Induction Overall Response Rate (ORR)|Induction ORR is the percentage of participants achieving a minimum of partial response (PR) over induction treatment based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. PR is a 50% or greater decrease of measured size of lymphadenopathy, hepatomegaly, splenomegaly as well as blood lymphocytes (over baseline), marrow infiltrate or B-lymphoid nodules and a 50% or greater increase from baseline in platelet count (or level >100,000/micro liter), hemoglobin (or level >11 grams/deciliter), neutrophils (or level >1500/microliter).|Disease was evaluated after weeks 8 and 16 of Part A and at 12, 18 and 24 weeks during part B.||||percentage of participants||90% Confidence Interval|Number
2673004|NCT01465230|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|36 months|Participants withdrew from study before primary outcome could be measured||||||
2673005|NCT01465178|Secondary|Change in Parameters of the Vitamin D Assay Panel|Secondary outcomes are change in cholecalciferol, 24,25(OH)D3 and free 25(OH)D3.|Baseline, 1 and 4 months post supplementation|Postmenopausal Caucasian women with 25(OH)D < 10 > 30 ng/ml|||ng/ml||Standard Deviation|Mean
2673006|NCT01465178|Primary|Change in Serum 25-hydroxy Vitamin D3|Our primary outcome variable is the effect of supplementation on change in serum 25(OH)D3;|Baseline, 1 and 4 months post supplementation||||ng/ml||Standard Deviation|Mean
2673007|NCT01465048|Secondary|Dynamics of Plasmodium Falciparum Parasite Growth Following PfSPZ Challenge Administered in Various Regimens|To determine the parasite growth dynamics of PfSPZ Challenge administered in various regimens using highly sensitive PCR for Plasmodium falciparum DNA.|21 days post administration of PfSPZ Challenge|||||||
2673008|NCT01465048|Secondary|Frequency, Incidence and Nature of Adverse Events and Serious Adverse Events Arising.|To assess the safety of PfSPZ Challenge administered in various regimens by analysing actively and passively collected data from clinical review of volunteers and laboratory measurements, including lab reports and adverse events.|Participants will be followed for the duration of the study, an expected average of 3 months|||||||
2673009|NCT01465048|Primary|Number of Participants Infected|To determine the infectivity rates of PfSPZ Challenge administered in various regimens by thick film microscopy and highly sensitive PCR for Plasmodium falciparum DNA.|21 days post administration of PfSPZ Challenge||||Participants|||Number
2673010|NCT01465022|Secondary|Infant Occipitofrontal Circumference Growth From 2-8 Weeks|Comparison of infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.|Week 2 and Week 8|"At 2 week point 64 participants for follow-up in combined pills arm, 63 for follow-up in progestin-only pills arm.~At 8 week point 41 participants for follow-up in combined pills arm, 40 for follow-up in progestin-only pills arm."|||cm||Standard Deviation|Mean
2673011|NCT01465022|Secondary|Infant Weight Growth From 2-8 Weeks|Comparison of infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.|Week 2 and Week 8|"At 2 week point 64 participants for follow-up in combined pills arm, 63 for follow-up in progestin-only pills arm.~At 8 week point 41 participants for follow-up in combined pills arm, 40 for follow-up in progestin-only pills arm."|||kg||Standard Deviation|Mean
2673012|NCT01465022|Secondary|Infant Length Growth From 2-8 Weeks|Comparison of infant length at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. Inclusion criteria of mother's who are actively breastfeeding.|Week 2 and Week 8|"At 2 week point 64 participants for follow-up in combined pills arm, 63 for follow-up in progestin-only pills arm.~At 8 week point 41 participants for follow-up in combined pills arm, 40 for follow-up in progestin-only pills arm."|||cm||Standard Deviation|Mean
2673013|NCT01465022|Secondary|Number of Participants Who Continued Birth Control Method After 6 Months|Proportion of participants who are continuing to use either combined estrogen-progestin pill or progestin-only pill up to 6 months after delivery|Baseline to Week 8, Week 8, 2-6 months|Participants available for follow-up through a 6 month period|||participants|||Number
2673014|NCT01465022|Primary|Number of Participants Who Continued to Breastfeed at 6 Months|Proportion of participants who are continuing to breastfeed from 2 months to 6 months after delivery|Baseline to Week 8, Week 8, 2-6 months|Participants available for follow-up through a 6 month period|||participants|||Number
2673015|NCT01464996|Secondary|Post Operative Sensitivity|Percentage of restorations with alfa scores. No sensitivity.|18 months post-baseline||||% of restorations with alfa scores|Participants||Number
2673016|NCT01464996|Secondary|Marginal Adaptation and/or Integrity|Percentage of restorations with alfa scores. No discoloration is present anywhere on the margin between the restoration and the tooth structure.|18 months post-baseline||||% of restorations with alfa scores|Participants||Number
2673017|NCT01464996|Secondary|Anatomic Form|Percentage of restorations with alfa scores. Restoration is continuous with existing anatomic form.|18 months post-baseline||||% of restorations with alfa scores|Participants||Number
2673018|NCT01464996|Secondary|Secondary Caries|Percentage of restorations with alfa scores. Absence of caries is evidenced by softness, opacity, or etching at the margin of the restoration.|18 months post-baseline||||% of restorations with alfa scores|Participants||Number
2673026|NCT01464931|Secondary|Time to Maximum Observed Serum Denosumab Concentration (Tmax)|Serum concentrations of denosumab were measured by an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 20 ng/mL.|Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113|PK Parameter Analysis Set|||days||Full Range|Median
2673027|NCT01464931|Secondary|Maximum Observed Serum Denosumab Concentration (Cmax)|Serum concentrations of denosumab were measured by an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 20 ng/mL.|Days 1 and 29 (predose), and on Days 8, 15, 36, 43, 57, 71, 85, and 113|Pharmacokinetic (PK) Parameter Analysis Set (all participants who received at least 1 dose of denosumab and for whom PK parameter estimates could be derived)|||μg/mL||Standard Deviation|Mean
2673028|NCT01464931|Secondary|Number of Participants With Adverse Events|"The severity of each adverse event (AE) was graded using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. The investigator assessed whether AEs were possibly related to study drug by answering the question: Is there a reasonable possibility that the event may have been caused by the investigational product? Abnormal laboratory findings without clinical significance (based on the investigator's judgment) were not recorded as AEs, however, laboratory value changes that required treatment or adjustment in current therapy were considered AEs. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal, • life-threatening (places the participant at immediate risk of death), • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other medically important serious event."|113 days|Safety analysis set|||participants|||Number
2673029|NCT01464931|Secondary|Percent Change From Baseline in Serum Magnesium Over Time||Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113|Safety analysis set with available data at each time point|||percent change||Inter-Quartile Range|Median
2673030|NCT01464931|Secondary|Percent Change From Baseline in Serum Phosphorus Over Time||Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113|Safety analysis set with available data at each time point|||percent change||Inter-Quartile Range|Median
2673031|NCT01464931|Secondary|Percent Change From Baseline in Albumin-adjusted Serum Calcium Over Time||Baseline and Days 2, 3, 6, 8, 11, 15, 22, 29, 30, 31, 34, 36, 39, 43, 57, 71, 85, and 113|Safety analysis set with available data at each time point|||percent change||Inter-Quartile Range|Median
2673032|NCT01464931|Secondary|Number of Participants With Hypomagnesemia Determined by CTCAE v.4.0 Criteria|The severity of hypomagnesemia (a low concentration of magnesium in the blood) was graded according to the common terminology criteria for adverse events (CTCAE) v.4.0 criteria: Grade 1: < LLN (1.5 mg/dL) - 1.2 mg/dL; Grade 2: < 1.2 - 0.9 mg/dL; Grade 3: < 0.9 - 0.7 mg/dL; Grade 4: < 0.7 mg/dL.|113 days|Safety analysis set|||participants|||Number
2673033|NCT01464931|Secondary|Number of Participants With Hypophosphatemia Determined by CTCAE v.4.0 Criteria|The severity of hypophosphatemia (a low concentration of phosphates in the blood) was graded according to the common terminology criteria for adverse events (CTCAE) v.4.0 criteria: Grade 1: < LLN (3 mg/dL) - 2.5 mg/dL; Grade 2: < 2.5 - 2.0 mg/dL; Grade 3: < 2.0 - 1.0 mg/dL; Grade 4: < 1.0 mg/dL.|113 days|Safety analysis set|||participants|||Number
2673034|NCT01464931|Secondary|Number of Participants With Hypocalcemia Determined by CTCAE v.4.0 Criteria|The severity of hypocalcemia (a low concentration of calcium, corrected for albumin, in the blood) was graded according to the common terminology criteria for adverse events (CTCAE) v.4.0 criteria: Grade 1: albumin-adjusted serum calcium < lower limit of normal (LLN; 9.2 mg/dL) to 8.0 mg/dL; Grade 2: albumin-adjusted serum calcium < 8.0 to 7.0 mg/dL; Grade 3: albumin-adjusted serum calcium < 7.0 to 6.0 mg/dL; Grade 4: albumin-adjusted serum calcium < 6.0 mg/dL.|113 days|Safety analysis set|||participants|||Number
2673035|NCT01464931|Primary|Number of Participants With Clinically Significant Hypocalcemia|Clinically significant hypocalcemia is defined as albumin-adjusted calcium < 7.0 mg/dL or symptomatic hypocalcemia. Symptomatic hypocalcemiais is defined as both a clinical adverse event of hypocalcemia and a concomitant symptom of hypocalcemia (e.g., hypoesthesia, paresthesia, muscle cramps, seizure, prolonged QT interval) that occurred along with the hypocalcemia event or decreased serum calcium levels.|113 days|Safety Analysis Set (all participants who received at least 1 dose of denosumab)|||participants|||Number
2673036|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Tmin||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||hr||Full Range|Median
2673037|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Cmin||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||ng/dL||Standard Deviation|Mean
2673038|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Cavg||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||ng/dL||Standard Deviation|Mean
2673039|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Cmax||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||ng/dL||Standard Deviation|Mean
2673040|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Tmax||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||hr||Full Range|Median
2673041|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||ng*hr/dL||Standard Deviation|Mean
2673718|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 8 (week 4)|||||||
2673042|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin)||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||hr||Full Range|Median
2673043|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin)||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||ng/dL||Standard Deviation|Mean
2673044|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Cavg||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||ng/dL||Standard Deviation|Mean
2673045|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax)||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||ng/dL||Standard Deviation|Mean
2673046|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax)||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||hr||Full Range|Median
2673047|NCT01464879|Secondary|Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ)||Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||ng*hr/dL||Standard Deviation|Mean
2673048|NCT01464879|Secondary|Responder Rate: Percentage of Subjects Whose Cavg Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With One Volume of FE 999303 Applied by Hand.||Days 1-7|FAS population was used for this analysis, which comprised of all subjects who had any available PK data.|||percentage of subjects|||Number
2673049|NCT01464879|Primary|Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator.|Descriptive statistics was used to present the outcome results.|Days 15-21, Days 22-28 & Days 29-35|Full Analysis Set (FAS) population was used for this analysis, which comprised of all subjects who had any available Pharmacokinetic (PK) data.|||percentage of subjects|||Number
2673050|NCT01464840|Primary|Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration|The primary outcome of this study will be the number of patients in each group that attain an azithromycin concentration in the various maternal and fetal tissues at least equivalent to the MIC 90 for common organisms involved in post-cesarean infections.|48 hours after delivery|No patients had azithromycin concentrations at least equivalent to the MIC 90.|||number of participants|||Number
2673051|NCT01464827|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose in Treatment-naïve Versus Null-responders|This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs and ribavirin in participants who were treatment-naïve versus those who were null-responders to previous HCV therapy (Groups F + G + H + I versus Groups K + L + M + N).|Post-Treatment Week 24|Intent-to-treat population; participants with missing data were counted as non-responders.|||percentage of participants|||Number
2673052|NCT01464827|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 3 DAAs With Versus Without Ribavirin|This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs with or without ribavirin (Group E versus Groups F + G + K + L).|Post-Treatment Week 24|Intent-to-treat population; participants with missing data were counted as non-responders.|||percentage of participants|||Number
2673053|NCT01464827|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment for 12 Weeks With 2 DAAs and Ribavirin Versus 3 DAAs and Ribavirin|This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks post-dose (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 2 DAAs (ABT-450/ritonavir plus ABT-333 [Group B] or ABT-450/ritonavir plus ABT-267 [Groups C + D + J]) and ribavirin versus 3 DAAs (ABT-450/ritonavir plus ABT-333 and ABT-267) and ribavirin (Groups F + G + K + L).|Post-Treatment Week 24|Intent-to-treat population; participants with missing data were counted as non-responders.|||percentage of participants|||Number
2673054|NCT01464827|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose Following Treatment of Different Durations With 3 Direct-acting Antiviral Agents (DAAs) and Ribavirin|This outcome measure compares the percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (HCV RNA < LLOQ at post-treatment Week 24) following treatment with 3 DAAs (ABT-450/ritonavir, ABT-267, and ABT-333) and ribavirin in both treatment naïve and null-responder participants for 8 weeks (Group A) versus 12 weeks (Groups F + G + K + L) versus 24 weeks (Groups H + I + M + N).|Post-Treatment Week 24|Intent-to-treat population; participants with missing data were counted as non-responders.|||percentage of participants|||Number
2673067|NCT01464697|Secondary|Depression Related to Progesterone Therapy in Late Perimenopause|"Final PHQ9 Score for Depression related to progesterone therapy in Late Perimenopause will be assessed based on the Personal Health Questionnaire‐9 (PHQ‐9) score changes within‐woman from baseline to the end‐of‐trial on progesterone compared with placebo.~Scale Name: PHQ9 Scale (0 = No Depression; 27 = Severe Depression)"|12 weeks||||PHQ9 Scale: 0-27||Standard Deviation|Mean
2673746|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 2 (week 1)|||||||
2673055|NCT01464827|Primary|Percentage of Participants With Sustained Virologic Response 24 Weeks Post-dose for 8 Weeks Versus 12 Weeks of Treatment With 3 DAAs and Ribavirin|"The percentage of participants achieving sustained virologic response 24 weeks after the last dose of study drug (SVR24), defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantitation (LLOQ), without any confirmed quantifiable (≥ LLOQ) post-treatment value before that time point. HCV RNA levels were measured from plasma by a central laboratory. The LLOQ for the assay was 25 IU/mL.~The primary efficacy endpoint was the comparison between treatment-naïve participants following 8 weeks of treatment with 3 DAAs and ribavirin and those with 12 weeks of treatment with 3 DAAs and ribavirin (Group A versus Group G)."|Post Treatment Week 24|Intent-to-treat population (all participants who received at least 1 dose of direct-acting antiviral agent); participants with missing data were counted as non-responders.|||percentage of participants|||Number
2673056|NCT01464827|Primary|Number of Participants With Adverse Events (AEs)|"An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.~The investigator assessed the relationship of each AE to the use of direct-acting antiviral agents (DAAs) and to ribavirin, and rated the severity of each event as either:~Mild: The AE was transient and easily tolerated by the participant; Moderate: The AE caused the participant discomfort and interrupted usual activities; Severe: The AE caused considerable interference with the participant's usual activities and could have been incapacitating or life-threatening.~A serious adverse event was any event that resulted in death, was life-threatening, resulted in or prolonged hospitalization, resulted in a congenital anomaly or persistent or significant disability or was any other important medical event requiring medical or surgical intervention."|From the time of study drug administration until 30 days following discontinuation of study drug administration (up to 28 weeks).|Safety population. Treatment groups differing only in ABT-450 dose (100 mg, 150 mg or 200 mg) were combined for safety analyses.|||participants|||Number
2673057|NCT01464788|Primary|Number of Participants With Symptomatic Intracranial Hemorrhage Within 48 Hours of tPA Administration|Symptomatic intracranial hemorrhage (sICH) is defined as any evidence of bleeding on CT scan that in the opinion of the treating physician and/or an independent safety monitor is associated with a clinically significant neurological worsening. A four or more point increase in the NIHSS score from baseline (or last score obtained prior to blood found on CT scan) to subsequent CT scan at the time of potential worsening can be used as a guide by the clinical investigator or safety monitor for what represents a significant worsening in neurologic status but sICH can include any worsening deemed significant by the clinical investigator or independent safety monitor.|48-hours|One patient in the high dose group did not receive Argatroban and another in the high dose group was lost to follow up; however, an intention-to-treat analysis was used and all 31 enrolled patients were included.|||participants|||Number
2673058|NCT01464788|Primary|Number of Participants With 0 or 1 on Modified Rankin Scale|Excellent functional outcome as measured by the number of patients with a 0 or 1 on the modified Rankin Scale (mRS) at day 90 as assessed by study personnel blinded to treatment.|90 days|One patient in the high dose group did not receive Argatroban and another in the high dose group was lost to follow up; however, an intention-to-treat analysis was used and all 31 enrolled patients were included.|||participants|||Number
2673059|NCT01464775|Secondary|Self-reported Pain|At each of the follow-up time points (6 weeks, 3 months, 6 months), questionnaires will be administered to the patient in order to quantify existing pain and to assess change in pain from baseline. Measurement tools for pain include a 10 centimeter visual analogue scale and the validated Endometriosis Health Profile (EHP-30).|6 weeks, 3 months and 6 months [post surgery]|||||||
2673060|NCT01464775|Primary|Sensitivity|Sensitivity in this study is defined as the number of lesions biopsied that are determined, based on pathology, to be endometriotic divided by the number of total lesions biopsied. It is hypothesized that the sensitivity for detecting endometriotic lesions will be higher in the white light/NBI arm compared to the white light/white light arm.|Day of surgery, day 1||||lesions|lesions||Number
2673061|NCT01464775|Primary|Diagnostic Yield|Diagnostic yield in this study is defined as the number of patients undergoing the surgical procedure who are diagnosed, based on pathology, with endometriosis. It is hypothesized that the diagnostic yield will be statistically and significantly higher among patients randomized to white light/NBI compared to those randomized to white light/white light.|Day of surgery, day 1||||participants|||Number
2673062|NCT01464723|Secondary|To Determine the Mean Number of Injections Per Year Patients in the Study Require.||5 years|The Principal Investigator has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful due to all study team members having left the University. No study data are available, attempts were made to find the data but were unsuccessful.||||||
2673063|NCT01464723|Secondary|To Determine Whether Change in Retinal Thickness is Correlated With Genotype||5 years|The Principal Investigator has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful due to all study team members having left the University. No study data are available, attempts were made to find the data but were unsuccessful.||||||
2673064|NCT01464723|Secondary|To Determine the Genotype at VEGF and HTRA1 SNPs of Patients Who Lose Visual Acuity (Gain <0 Letters) at 4, 6 and 12 Months After Initial Treatment.||5 years|The Principal Investigator has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful due to all study team members having left the University. No study data are available, attempts were made to find the data but were unsuccessful.||||||
2673065|NCT01464723|Primary|To Determine the Genotype at VEGF and HTRA1 SNPs of Patients Gaining ≥ 0 Letters of Visual Acuity in Response to Ranibizumab Treatment Over a 4 Month Period.||5 years|The Principal Investigator has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful due to all study team members having left the University. No study data are available, attempts were made to find the data but were unsuccessful.||||||
2673066|NCT01464697|Secondary|Percentage of Women With Perceived Changes in Menstrual Flow|Menstrual flow related to progesterone therapy in perimenopause was assessed based on Women's Perceived Changes Questionnaire of changes in the experience of menstrual flow/vaginal bleeding from the Final Questionnaire.|12 weeks|The discrepancy in the Number of Participants analyzed is due to missing data on the Final Questionnaire.|||Participants|||Count of Participants
2673068|NCT01464697|Secondary|Depression Related to Progesterone Therapy in Early Perimenopause|"Final PHQ9 Score for Depression related to progesterone therapy in Early Perimenopause will be assessed based on the Personal Health Questionnaire‐9 (PHQ‐9) score changes within‐woman from baseline to the end‐of‐trial on progesterone compared with placebo.~Scale Name: PHQ9 Scale (0 = No Depression; 27 = Severe Depression)"|12 weeks||||PHQ9 Scale: 0-27||Standard Deviation|Mean
2673069|NCT01464697|Secondary|Depression Related to Progesterone Therapy in Whole Population|"Final PHQ9 (Personal Health Questionnaire 9) Score for Depression related to progesterone therapy in perimenopause will be assessed based on the Personal Health Questionnaire‐9 (PHQ‐9) score changes within‐woman from baseline to the end‐of‐trial on progesterone compared with placebo.~Scale Name: PHQ9 Scale (0 = No Depression; 27 = Severe Depression)"|12 weeks||||PHQ9 Scale: 0-27||Standard Deviation|Mean
2673070|NCT01464697|Secondary|Women's Perceived Changes in Night Sweats in Late Perimenopause|"Women's Perceived Changes Questionnaire of changes (from ‐5 to 0 to +5) in Nighttime Night Sweats (both number and severity) as recorded on the Final Questionnaire and by subgroup for Late Perimenopause.~Scale Name: Perceived Night Sweats Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5."|12 weeks||||Change Scale -5 to +5, no change is 0||Standard Deviation|Mean
2673071|NCT01464697|Secondary|Women's Perceived Changes in Daytime Hot Flushes in Late Perimenopause|"Women's Perceived Changes Questionnaire of changes (from ‐5 to 0 to +5) in Daytime Hot Flushes (both number and severity) as recorded on the Final Questionnaire and by subgroup for Late Perimenopause.~Scale Name: Perceived Daytime Hot Flush Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5."|12 weeks||||Change Scale -5 to +5, no change is 0||Standard Deviation|Mean
2673072|NCT01464697|Secondary|Women's Perceived Changes in Night Sweats in Early Perimenopause|"Women's Perceived Changes Questionnaire of changes (from ‐5 to 0 to +5) in Nighttime Night Sweats (both number and severity) as recorded on the Final Questionnaire and by subgroup for Early Perimenopause.~Scale Name: Perceived Night Sweats Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5."|12 weeks||||Change Scale -5 to +5, no change is 0||Standard Deviation|Mean
2673073|NCT01464697|Secondary|Women's Perceived Changes in Daytime Hot Flushes in Early Perimenopause|"Women's Perceived Changes Questionnaire of changes (from ‐5 to 0 to +5) in Daytime Hot Flushes (both number and severity) as recorded on the Final Questionnaire and by subgroup for Early Perimenopause.~Scale Name: Perceived Daytime Hot Flush Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5."|12 weeks||||Change Scale -5 to +5, no change is 0||Standard Deviation|Mean
2673074|NCT01464697|Secondary|Perception of Interference of Perimenopausal Mood Changes With Usual Activities in Women|"Final perceptions of interference of perimenopausal mood changes with usual activities (as recorded by the CeMCOR Perimenopause Interference Questionnaire [CeMCOR PIQ]) in women randomized to the progesterone versus to placebo.~Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference)"|12 weeks||||Visual Analogue scale 0-100 mm||Standard Deviation|Mean
2673075|NCT01464697|Secondary|Perception of Interference of Perimenopausal Body Changes With Usual Activities in Women|"Final perceptions of interference of perimenopausal body changes with usual activities (as recorded by the CeMCOR Perimenopause Interference Questionnaire [CeMCOR PIQ]) in women randomized to the progesterone versus to placebo.~Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference)"|12 weeks||||Visual Analogue scale 0-100 mm||Standard Deviation|Mean
2673076|NCT01464697|Secondary|Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women - Late Perimenopause|"Final perceptions of interference of overall perimenopausal changes with usual activities (as recorded by the CeMCOR Perimenopause Interference Questionnaire [CeMCOR PIQ]) at 12 weeks in women randomized to the progesterone versus to placebo.~Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference)"|12 weeks||||Visual Analogue scale 0-100 mm||Standard Deviation|Mean
2673077|NCT01464697|Secondary|Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women - Early Perimenopause|"Final perceptions of interference of overall perimenopausal changes with usual activities (as recorded by the CeMCOR Perimenopause Interference Questionnaire [CeMCOR PIQ]) at 12 weeks in women randomized to the progesterone versus to placebo.~Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference)"|12 weeks||||Visual Analogue scale 0-100 mm||Standard Deviation|Mean
2673078|NCT01464697|Secondary|Perception of Interference of Overall Perimenopausal Changes With Usual Activities in Women|"Final perceptions of interference of overall perimenopausal changes with usual activities (as recorded by the CeMCOR PIQ - Centre for Menstrual Cycle and Ovulation Research Perimenopause Interference Questionnaire) at 12 weeks in women randomized to the progesterone versus to placebo.~Scale Name: Perceived Interference Score: 100 mm line (0 = No Interference; 100 = Severe Interference)"|12 weeks||||Visual Analogue scale 0-100 mm||Standard Deviation|Mean
2673079|NCT01464697|Secondary|Women's Perceived Changes in Quality of Sleep for Whole Population|"Women's Perceived Changes Questionnaire of changes (from ‐5 to 0 to +5) in the quality of sleep over the three months of the trial as assessed by the Final Questionnaire based on their random assignment to the progesterone or placebo arms of this RCT (Randomized Controlled Trial) and by Early/Late perimenopause.~Scale Name: Quality of Sleep Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. This is women's perception of the change from run-in to when they recorded it at the end of the trial (at 12 weeks).~No calculation is needed."|12 weeks||||Change Scale -5 to +5, no change is 0||Full Range|Mean
2673080|NCT01464697|Secondary|Women's Perceived Changes in Night Sweats for Whole Population|"Women's Perceived Changes Questionnaire of changes (from ‐5 to 0 to +5) in Nighttime Night Sweats (both number and severity) as recorded on the Final Questionnaire.~Scale Name: Night Sweats Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. This is women's perception of the change from run-in to when they recorded it at the end of the trial (at 12 weeks).~No calculation is needed."|12 weeks||||Change Scale -5 to +5, no change is 0||Standard Deviation|Mean
2673081|NCT01464697|Secondary|Women's Perceived Changes in Daytime Hot Flushes for Whole Population|"Women's Perceived Changes Questionnaire of changes (from ‐5 to 0 to +5) in Daytime Hot Flushes (both number and severity) as recorded on the Final Questionnaire.~Scale Name: Daytime Hot Flush Change Decrease is -5 to -1; No change is 0; Increase is +1 to +5. This is women's perception of the change from run-in to when they recorded it at the end of the trial (at 12 weeks).~No calculation is needed."|12 weeks||||Change Scale -5 to +5, no change is 0||Standard Deviation|Mean
2673083|NCT01464697|Secondary|Sleep Problems|"Daily average rating of sleep problems (0-4) from prospective daily calendar records.~Outcome is the average daily rating during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Scale name: Sleep Problems (4=Worst, 0=None)"|12 weeks||||Units on a ordinal Scale||Standard Deviation|Mean
2673084|NCT01464697|Primary|Subgroup Analysis for Those With Frequent and Severe VMS - VMS Score|"VMS Score for those with more frequent (≥7 per day and moderate to severe episodes of intensity 2-4) at baseline. Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows:~Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity)."|12 weeks||||Units of Vasomotor Symptom Score||Standard Deviation|Mean
2673085|NCT01464697|Primary|VMS Score by Late Perimenopause|subgroup analysis of VMS Score by Late Perimenopause (those with skipped or ≥60 day cycle lengths). Outcome is the average daily VMS Score during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity).|12 weeks||||Units of Vasomotor Symptom Score||Standard Deviation|Mean
2673086|NCT01464697|Primary|VMS Score by Early Perimenopause|subgroup analysis of VMS Score by Early Perimenopause (no skipped period or <60 day cycle length). Outcome is the average daily VMS Score during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate. Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows: Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity).|12 weeks||||Units of Vasomotor Symptom Score||Standard Deviation|Mean
2673087|NCT01464697|Primary|Severity of VMS|Severity (0-4, 0=no intensity, 4=extreme intensity) of hot flushes/hot flashes and night sweats per day from prospective daily calendar records. Daily summary score is the maximum of daytime and nighttime severity. Outcome is the average daily severity during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate.|12 weeks||||Units on a Scale of 0-4||Standard Deviation|Mean
2673088|NCT01464697|Primary|Frequency of VMS|Frequency (count) of hot flushes/hot flashes and night sweats per day from prospective daily calendar records. Outcome is the average daily VMS Frequency (day + night) during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate.|12 weeks||||episodes per day||Standard Deviation|Mean
2673089|NCT01464697|Primary|Vasomotor Symptoms (VMS)/ VMS Score - at 12 Weeks|"Participants will complete a daily calendar (Daily Perimenopause Hot Flush Calendar) to record frequency (actual number) and severity (quantified by ordinal scale ie 0=none to 4=extreme) of hot flushes and night sweats. The VMS Score will be calculated as follows:~Daily VMS Score = (# night sweats) x (severity) + (#hot flushes) x (severity).~Outcome is the average daily VMS Score during the final 28 days of therapy, to be analysed with 28-day run-in scores as covariate."|12 weeks|Intent to Treat Population|||Units of Vasomotor Symptom Score||Standard Deviation|Mean
2673090|NCT01464619|Secondary|Change in Parenting Discipline|Change from baseline to follow-up of the Parenting Scale (PS), a validated self-report measure of parents' self-reported parenting discipline. Total scores range from 1 to 7 with lower scores indicating better parenting discipline.|3 months||||units on a scale||Standard Deviation|Mean
2673091|NCT01464619|Secondary|Change in Social Support|Change from baseline to follow-up of the Multidimensional Scale of Perceived Social Support (MSPSS), a validated self-report measure of perceived social support from family, friends, and a significant other. Total scores range from 12 to 84 with higher scores indicating greater perceived social support.|3 months||||units on a scale||Standard Deviation|Mean
2673092|NCT01464619|Secondary|Change in Parenting Stress|Change from baseline to follow-up of the Parenting Stress Index-Short Form Total (PSI-SF), a validated self-report measure of parenting stress. Total scores range from 36 to 180 with higher scores indicating greater levels of parenting stress.|3 months||||units on a scale||Standard Deviation|Mean
2673093|NCT01464619|Secondary|Feasibility of a Parent Coaching Intervention Incredible Years (IY) That Has Been Adapted for Depressed Caregivers.|Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 1 session of IY.|3 months||||participants|||Number
2673094|NCT01464619|Secondary|Attendance at 6 or More Incredible Years (IY) Sessions|Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 6 sessions of IY.|3 months||||percentage of subjects enrolled|||Number
2673095|NCT01464619|Secondary|Acceptability of the Parent Coaching Intervention|"Acceptability of the parent coaching intervention will be assessed by a response to the question How did you like the parenting program? at the conclusion of the parent sessions. the responses ranged from 1 (highly disliked) to 5 (highly liked)"|3 months|No satisfaction measures were collected from the control group, as they received the intervention in a delayed format after their study participation had ended.|||units on a scale||Standard Deviation|Mean
2673096|NCT01464619|Secondary|Change in Caregiver Depressive Symptoms|Change from baseline to follow-up of the Beck Depression Scale-II (BDI-II), a validated self-report measure of depressive symptoms. The scale range is from 0 to 63 with higher scores indicating worse depressive symptoms.|3 months||||units on a scale||Standard Deviation|Mean
2673097|NCT01464619|Primary|Feasibility of a Parent Coaching Intervention|Feasibility of the parent coaching intervention will be assessed by the proportion of participants who attended at least 10 sessions of Incredible Years over 3 months.|3 months|Original number who enrolled and were assigned to each group.|||participants|||Number
2673098|NCT01464424|Primary|Overall Mean Intraocular Pressure (IOP)|IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm) for an overall mean. The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. Per-protocol dataset was pre-specified for this non-inferiority analysis.|Week 6|Per protocol: All subjects who received study medication, completed all study visits as per the protocol timelines and criteria, and satisfied inclusion/exclusion criteria.|||millimeters mercury (mmHg)||Standard Deviation|Mean
2673099|NCT01464424|Secondary|Mean IOP at Each After Office Hour Evaluation Timepoint|IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm). The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye.|Week 6: 4 pm, 6 pm, 8 pm|Per protocol: All subjects who received study medication, completed all study visits as per the protocol timelines and criteria, and satisfied inclusion/exclusion criteria.|||millimeters mercury (mmHg)||Standard Deviation|Mean
2673100|NCT01464359|Secondary|Clinical Disease Response|Defined as leukemia clearance and complete remission. Patients will be followed for disease response for 2 years from transplantation unless: consent is withdrawal, patient is unevaluable - if a patient is not evaluable, follow only untilthe resolution or stabilization of treatment related toxicity, new anti-cancer treatment is started, patient is discharged to hospice (terminal) care.|2 Years from Transplantation||||Participants|||Count of Participants
2673101|NCT01464359|Secondary|Duration of Survival||2 years after Transplantation.||||Participants|||Count of Participants
2673102|NCT01464359|Secondary|Duration of Survival||1 year after Transplantation.||||Participants|||Count of Participants
2673103|NCT01464359|Secondary|Duration of Survival||6 months after Transplantation.||||Participants|||Count of Participants
2673104|NCT01464359|Secondary|Clinical Disease Response|Defined as leukemia clearance and complete remission. Patients will be followed for disease response for 1 year from transplantation unless: consent is withdrawal, patient is unevaluable - if a patient is not evaluable, follow only until the resolution or stabilization of treatment related toxicity, new anti-cancer treatment is started, patient is discharged to hospice (terminal) care.|1 Year from Transplantation||||Participants|||Count of Participants
2673105|NCT01464359|Secondary|Transplant-Related Mortality||Day 180 after Transplantation||||Participants|||Count of Participants
2673106|NCT01464359|Secondary|Incidence of Acute Graft-Versus-Host Disease||Day 60||||Participants|||Count of Participants
2673107|NCT01464359|Secondary|Incidence of Graft Failure|Incidence of graft failure defined as an absolute neutrophil count of less than 500/uL and a bone marrow that is less than 5% cellular (marrow aplasia)|Day 42||||Participants|||Count of Participants
2673108|NCT01464359|Primary|Disease Free Survival|The primary endpoint is a disease free survival at 3 months in patients with chemotherapy refractory AML after a double T-cell depleted (TCD) umbilical cord blood (UCB) transplantation where one TCD unit is activated overnight in IL-2 followed by the administration of two courses of IL-2 three times a week for 6 doses beginning on day +3 and on day +60 to expand UCB-derived NK cells in vivo.|At 3 months||||participants|||Number
2673109|NCT01464346|Other Pre-specified|Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Buttock Insertion Site, With Calibration Every 12 Hours|This measure is the Mean Absolute Relative Difference (MARD) between sensor glucose values and paired YSI plasma glucose values for sensors inserted in the Buttock insertion site, with Calibration every 12 hours, across all Buttock insertion site participants and all days. MARD is calculated by absolute value of [(sensor glucose value - YSI glucose value) / YSI glucose value] * 100|Days 1, 3 and 6 of sensor wear||||percentage of difference||Standard Deviation|Mean
2673110|NCT01464346|Other Pre-specified|Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Buttock Insertion Site, With 3-4 Calibrations Throughout the Day|This measure is the Mean Absolute Relative Difference (MARD) between sensor glucose value and paired YSI plasma glucose measurement for sensors inserted in the Buttock insertion site, with 3-4 Calibrations, across all Buttock insertion site participants and all days. MARD is calculated by absolute value of [(sensor glucose value - YSI glucose value) / YSI glucose value] * 100|Days 1, 3 and 6 of sensor wear||||percentage of difference||Standard Deviation|Mean
2673111|NCT01464346|Other Pre-specified|Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Abdomen Insertion Site, With Calibration Every 12 Hours|This is a measure of Mean Absolute Relative Difference (MARD) between the sensor and the paired YSI plasma glucose value for sensors inserted in the Abdomen insertion site, with Calibration every 12 hours, across all Abdomen insertion site participants and all days. MARD is calculated by absolute value of [(sensor glucose value - YSI glucose value) / YSI glucose value] * 100|Days 1, 3 and 6 of sensor wear||||percentage of difference||Standard Deviation|Mean
2673112|NCT01464346|Other Pre-specified|Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Abdomen Insertion Site, With 3-4 Calibrations Throughout the Day|This measure is the Mean Absolute Relative Difference (MARD) between sensor glucose values and and paired YSI plasma glucose values for Abdomen insertion site, with 3-4 Calibrations, across all Abdomen insertion site participants and all days. MARD is calculated by absolute value of [(sensor glucose value - YSI glucose value) / YSI glucose value] * 100|Days 1, 3 and 6 of sensor wear||||percentage of difference||Standard Deviation|Mean
2673113|NCT01464346|Secondary|Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With 3-4 Calibrations Per Day, Combined Abdomen and Buttock Insertion|Secondary endpoint is mean of daily percentage of sensor values within 30% of reference value (within 22.5 mg/dL if YSI <75 mg/dL) with 3-4 calibrations per day, combined abdomen and buttock insertion sites across all participants and all days.|Days 1, 3 and 6 of sensor wear||||percentage of paired readings||95% Confidence Interval|Mean
2673114|NCT01464346|Primary|Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With Minimum Calibration, Combined Abdomen and Buttock Insertion Sites|Primary endpoint is mean of daily percentage of sensor values within 30% of reference value (within 22.5 mg/dL if YSI <75 mg/dL) with the minimum calibration (every 12 hour), combined abdomen and buttock insertion sites across all participants and all days.|Days 1, 3 and 6 of sensor wear||||percentage of paired readings||95% Confidence Interval|Mean
2673115|NCT01464333|Secondary|Change in C-Reactive Protein (CRP) Levels Over Time|CRP values were measured as an inflammatory parameter. Low CRP values mean less inflammation.|From first dose of Humira up to 3 years|Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment|||mg/dL||Standard Deviation|Mean
2673116|NCT01464333|Secondary|Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)|Endoscopic remission per endoscopy sub score.|From first dose of Humira up to 3 years|Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment|||Participants|||Count of Participants
2673117|NCT01464333|Secondary|Change in WPAI: CD Activity Impairment Over Time|WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Activity impairment (percentage of activity impairment due to CD ) is calculated as the patient's rating of how much CD affected their ability to do regular daily activities, other than working at a job (0 = no effect; 10 = completely prevented from working) / 10 * 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|From first dose of Humira up to 3 years|Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment|||Percent activity impairment||Standard Deviation|Mean
2673118|NCT01464333|Secondary|Change in WPAI: CD Overall Work Impairment Over Time|WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment [OWI]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|From first dose of Humira up to 3 years|Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment|||Percent overall work impairment||Standard Deviation|Mean
2673119|NCT01464333|Secondary|Change in WPAI: CD Presenteeism Over Time|WPAI: CD is a questionnaire used to evaluate lost productivity due to CD; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Presenteeism (percentage of impairment while working due to CD ) is calculated as the patient's rating of how much CD affected productivity while working (0 = no effect; 10 = completely prevented from working) / 10 * 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|From first dose of Humira up to 3 years|Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment|||Percent impairment while working||Standard Deviation|Mean
2673120|NCT01464333|Secondary|Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time|WPAI: CD is a questionnaire used to evaluate lost productivity due to CD; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Absenteeism (percentage of work time missed due to CD) is calculated as the number of hours of work missed due to CD / (number of hours of work missed due to CD + number of hours worked) * 100. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|From first dose of Humira up to 3 years|Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment|||percentage of work time missed||Standard Deviation|Mean
2673121|NCT01464333|Secondary|Change in Crohn's Disease Activity Index (CDAI) Score Over Time|The Change in Crohn's Disease Activity Index (CDAI) is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items and ranges from 0 to about 600. The 8 items are frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Low scores indicate low activity of Crohn's disease. In general, CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. A negative change from Baseline indicates improvement.|From first dose of Humira up to 3 years|Efficacy Analysis Set: patients who have assessments at the first administration and the subsequent assessment|||units on a scale||Standard Deviation|Mean
2673122|NCT01464333|Primary|Number of Participants With Adverse Events|An adverse event was any untoward or unintended symptoms (including abnormal laboratory findings), condition or illness, which are not always related to Humira. Please see Adverse Event section below for more details.|From first dose of Humira up to 3 years|Safety Analysis Set|||participants|||Number
2673123|NCT01464307|Secondary|Ashworth Scale (AS) for Plantar Flexors at All Post-Baseline Visits|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Here, 'n' specifies those subjects who were evaluated for this outcome measure at given time point.|Baseline, Week 4, 8, and 12|The Full Analysis Set (FAS) included subjects in the Safety Evaluation Set (SES) of the main period for whom the primary efficacy variable was available, whereby SES is the subset of all subjects who were exposed to IP in the main period at least once.|||Units on a scale||Standard Deviation|Mean
2673124|NCT01464307|Secondary|Response Rate for Plantar Flexors at All Post-Baseline Visits for Subjects With an Improvement (Reduction) of at Least 1 Point From Baseline in the Ashworth Scale (AS)|Response is defined as an improvement (reduction) of the plantar flexor Ashworth Score by at least one score point. The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4, 8, and 12|"The FAS included subjects in SES of main period for whom primary efficacy variable was available, whereby SES is subset of all subjects who were exposed to IP in main period at least once. Here, “N”(Number of Participants Analyzed) and n signifies those participants who were evaluable for this outcome measure and at given time point respectively."|||Percentage of Participants|||Number
2673125|NCT01464307|Primary|Co-primary Variable: Investigator's Global Assessment of Efficacy at Week 12|A 4-point Likert scale will be used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Investigator's Global Assessment of Efficacy at Week 12 will be a co-primary outcome measure to fulfill post marketing commitments for U.S. regulatory authorities only. Elsewhere, it will be a secondary outcome measure.|Baseline to Week 12|The Full Analysis Set (FAS) included subjects in the Safety Evaluation Set (SES) of the main period for whom the primary efficacy variable was available, whereby SES is the subset of all subjects who were exposed to IP in the main period at least once.|||Percentage of Participants|||Number
2673126|NCT01464307|Primary|Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4|The AS is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Baseline and Week 4|The Full Analysis Set (FAS) included subjects in the Safety Evaluation Set (SES) of the main period for whom the primary efficacy variable was available, whereby SES is the subset of all subjects who were exposed to IP in the main period at least once.|||Units on a scale||Standard Deviation|Mean
2673127|NCT01464255|Primary|Lens Fit - Post-Blink Lens Movement Prior to Removal|The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement prior to removal of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). (mm).|7 days and 14 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2|||mm||Standard Deviation|Mean
2673128|NCT01464255|Primary|Lens Fit - Post-Blink Lens Movement After Insertion|The ophthalmologist's objective assessment of lens fit measurement of post-blink lens movement after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm).|Baseline and 7 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2|||mm||Standard Deviation|Mean
2673129|NCT01464255|Secondary|Overall Lens Pair Preference|Participant's subjective rating for overall preference for lens pair #1 or Pair #2 based on comfort, vision and handling. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit||||percentage of participants|||Number
2673130|NCT01464255|Secondary|Overall Preference - Handling, Removing|Participant's subjective rating for overall preference of lens ease of handling at removing for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit||||percentage of participants|||Number
2673131|NCT01464255|Secondary|Overall Preference - Handling, Inserting|Participant's subjective rating for overall preference of lens ease of handling at inserting for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit||||percentage of participants|||Number
2673132|NCT01464255|Secondary|Overall Preference - Dryness Before Removal|Participant's subjective rating for overall preference of lens dryness immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit||||percentage of participants|||Number
2673133|NCT01464255|Secondary|Overall Preference - Dryness After Insertion|Participant's subjective rating for overall preference of lens dryness immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit||||percentage of participants|||Number
2673134|NCT01464255|Secondary|Overall Preference - Comfort Before Removal|Participant's subjective rating for overall preference of lens comfort immediately before removal for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit||||percentage of participants|||Number
2673135|NCT01464255|Secondary|Overall Preference - Comfort After Insertion|Participant's subjective rating for overall preference of lens comfort immediately after insertion for lens pair #1 or Pair #2. Surveyed at 14 days after baseline visit. (Each pair worn for one week daily disposable wear basis, at least 8 hours per day, 7 days per week). Rated by Likert scale, (forced choices - Strongly Prefer New Lenses (Week 2), Slightly Prefer New Lenses (Week 2), No Preference, Slightly Prefer Previous Lenses (Week 1), Strongly Prefer Previous Lenses (Week 1). Reported as Strongly Prefer Test Lenses, Slightly Prefer Test Lenses, No Preference, Slightly Prefer Control Lenses, Strongly Prefer Control Lenses.|14 days from baseline visit||||percentage of participants|||Number
2673136|NCT01464255|Primary|Lens Fit - Tightness at One Week|The ophthalmologist's rating of lens fit measurement of push-up tightness of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).|7 days and 14 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2|||percentage of tightness||Standard Deviation|Mean
2673137|NCT01464255|Primary|Lens Fit - Tightness After Insertion|The ophthalmologist's rating of lens fit measurement of push-up tightness after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (0-100%, 5% steps, 0%=excessively loose, 50%=optimum, 100%=excessively tight ).|Baseline and 7 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2|||percentage of tightness||Standard Deviation|Mean
2673138|NCT01464255|Primary|Lens Fit - Decentration at One Week|The ophthalmologist's objective assessment of lens fit measurement of decentration of Pair #1 (measured at 7 days after baseline visit) and Pair #2 (measured at 14 days after baseline visit). Each pair worn for one week daily disposable wear basis (at least 8 hours per day, 7 days per week). Lenses worn minimum 2 hours prior to visit. (mm, horizontal and vertical).|7 days and 14 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2|||mm||Standard Deviation|Mean
2673139|NCT01464255|Primary|Lens Fit - Decentration After Insertion|The ophthalmologist's objective assessment of lens fit measurement of decentration after insertion (20 minutes settling) of Pair #1 (measured at baseline visit) and Pair #2 (measured at 7 days after baseline visit). (mm, horizontal and vertical).|Baseline and 7 days from baseline visit|Of 49 total participants, 49 wore pair #1 and 49 crossed over to wear pair #2|||mm||Standard Deviation|Mean
2673140|NCT01464229|Primary|SQ Anger/Hostility Scale|"Of the 20 patients randomized, data was analyzed for 13 completers. Symptom Questionnaire (SQ) Anger/Hostility Scale; this is a 23-item subscale of the 92-item Symptom Questionnaire.~This score ranges from 0 to 23; higher values represent higher anger and hostility."|9 weeks||||Score on Anger/Hostility Scale||Standard Deviation|Mean
2673141|NCT01464190|Primary|Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)|Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.|Every 4 weeks from baseline to Week 28|For the Primary Outcome, data from the Full Analysis Set for PA-CL-05B (FAS5B) was used. The FAS5B consists of all subjects who enrolled in PA-CL-05B, received at least 1 dose of PA-CL-05B medication, and had at least 1 efficacy assessment after the PA-CL-05B study entry visit.|||pg/mL||Standard Deviation|Mean
2673142|NCT01464190|Primary|Change From Baseline and Levels at Each Time Point for Serum Calcium|Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.|Every 4 weeks from baseline to Week 28|For the Primary Outcome, data from the Full Analysis Set for PA-CL-05B (FAS5B) was used. The FAS5B consists of all subjects who enrolled in PA-CL-05B, received at least 1 dose of PA-CL-05B medication, and had at least 1 efficacy assessment after the PA-CL-05B study entry visit.|||mg/dL||Standard Deviation|Mean
2673143|NCT01464190|Primary|Change From Baseline and Levels at Each Time Point for Serum Phosphorus|Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.|Every 4 weeks from baseline to Week 28|For the Primary Outcome, data from the Full Analysis Set for PA-CL-05B (FAS5B) was used. The FAS5B consists of all subjects who enrolled in PA-CL-05B, received at least 1 dose of PA-CL-05B medication, and had at least 1 efficacy assessment after the PA-CL-05B study entry visit.|||mg/dL||Standard Deviation|Mean
2673144|NCT01464021|Secondary|Percent Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)|The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3).|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.|||percent change||Standard Deviation|Mean
2673145|NCT01464021|Secondary|Percent Change From Baseline in Physician's Global Assessment of RA Disease Activity|A horizontal VAS (100 mm) measure of the physician's global assessment of the participant's current RA disease activity, ranging from 0 mm (very good condition) to 100 mm (very bad condition).|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.|||percent change||Standard Deviation|Mean
2673146|NCT01464021|Secondary|Percent Change From Baseline in Patient's Assessment of Pain|A horizontal VAS (100 mm) measure of the participant's assessment of RA pain, where the participant was asked to place a vertical mark on the line to indicate how much pain they have had due to RA in the past week, ranging from 0 mm (no pain) to 100 mm (pain as bad as it could be).|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.|||percent change||Standard Deviation|Mean
2673147|NCT01464021|Secondary|Percent Change From Baseline in Patient's Global Assessment of Disease Activity|A horizontal Visual Analog Scale (VAS) (100 mm) measure of the participant's global assessment of RA disease activity, where the participant was asked to place a vertical mark on the line to indicate how well their RA has been within the last 24 hours, ranging from 0 mm (very well) to 100 mm (very poorly).|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.|||percent change||Standard Deviation|Mean
2673148|NCT01464021|Secondary|Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)|Rate at which red blood cells sediment in a period of 1 hour, a non-specific measure of inflammation; a higher rate = more inflammation.|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.|||percent change||Standard Deviation|Mean
2673149|NCT01464021|Secondary|Percent Change From Baseline in C-reactive Protein|C-reactive protein level in serum (mg/dL)|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.|||percent change||Standard Deviation|Mean
2673150|NCT01464021|Secondary|Percent Change From Baseline in Tender and Swollen Joint Counts|Change in number of tender joints and swollen joints for 28 assessed joints.|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available.|||Percent change||Standard Deviation|Mean
2673206|NCT01463202|Secondary|Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA|Edinburgh Postnatal Depression Scale (EPDS) score after postpartum or delayed initiation of DMPA: minimum possible score 0, maximum possible score 30; score of 12 or greater is a positive screen for postpartum depression|8 weeks postpartum|Excludes 14 participants with a missed call at 8 weeks postpartum|||scores on a scale||Inter-Quartile Range|Median
2673151|NCT01464021|Secondary|Percent Change From Baseline in Disease Activity Score (DAS)28 Erythrocyte Sedimentation Rate (ESR)|The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score > 5.1 indicates high disease activity, ≤ 5.1 indicates moderate disease activity, ≤ 3.2 indicates low disease activity, and ≤ 2.6 indicates clinical remission.|Weeks 4, 8, 12, 26|Participants who received at least one injection of adalimumab and have the necessary clinical data available|||percent change||Standard Deviation|Mean
2673152|NCT01464021|Primary|Number of Participants With at Least a Moderate European League Against Rheumatism (EULAR) Response|"A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the Disease Activity Score (DAS)28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity.~A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2.~A Moderate Response is defined as either:~an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2.~No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1"|Week 12|Participants who received at least 6 consecutive injections of adalimumab (every other week) and have the necessary clinical data for both the Baseline and the Week 12 visit available.|||participants|||Number
2673153|NCT01463982|Secondary|Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR)|"by RECIST guideline Objective response rate = (Number of subjects with best overall response as confirmed CR or PR / Total number of subjects)*100.~Response rate = (Number of subjects with best overall response as CR or PR / Total number of subjects)*100.~Disease control rate = (Number of subjects with best overall response as confirmed CR or PR or SD / Total number of subjects)*100."|tumor response evaluation can continue to receive the study drug until PD confirmation||||percentage of participants||95% Confidence Interval|Number
2673154|NCT01463982|Primary|Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination|If Dose Limiting Toxicity(DLT) was not observed in the third subject at a dose level from the first study drug dosing date (Day 1) to the end of Cycle 1(21 days), increase the dose to the next level and enroll subjects; enrollment up to Level 4 was allowed. (NCI-CTCAE version 3.0)|Cycle 1 (21 days)||||percentage of participants||95% Confidence Interval|Number
2673155|NCT01463878|Secondary|Quadriceps Muscle Volume|The quadriceps muscle volume will be estimated by 2-dimensional ultrasound imaging at enrollment and at the end of the study period (when the patient is being transferred from the ICU or no longer receiving tube feeds). The change in muscle mass during the ICU stay will be compared between the control and intervention groups.|First versus last measurment in ICU. Up to 14 days (average 7 days)|||||||
2673156|NCT01463878|Primary|Glycemic Variability|The patients blood glucose levels will be monitored with a continuous blood glucose monitor which records the calibrated blood glucose level every minute. The mean blood glucose over the patients entire ICU stay (up to 14 days) as well as the mathematical variation (fluctuation) in blood glucose levels will be calculated. The degree of glycemic variation will be assessed by a number of mathematical formula, including mean amplitude of glycemic excursions (MAGE). These parameters will be compared between the control and intervention groups.|Entire ICU stay. Up to 14 days in the ICU (average about 7 days)||||mg/dl (MAGE)||Standard Deviation|Mean
2673157|NCT01463696|Secondary|AUC at Time of Last Sample (AUClast) for MK-8242|PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8 and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.|Cycle 1, Day 1 pre-dose and through 12 hours post dose; Cycle 1 Day 7 pre-dose and through 48 hours post dose|The APaT population consisted of all participants who received at least one dose of study drug.|||hr*nM||Geometric Coefficient of Variation|Geometric Mean
2673158|NCT01463696|Secondary|Area Under the Concentration Time Curve From Hour 0 to Hour 12 (AUC0-12) for MK-8242|PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8 and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.|Cycle 1, Day 1 and Day 7, Hour 0 through Hour 12|The APaT population consisted of all participants who received at least one dose of study drug.|||hr*nM||Geometric Coefficient of Variation|Geometric Mean
2673159|NCT01463696|Secondary|Time to Maximum Plasma Concentration (Tmax) of MK-8242|PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8 and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.|Cycle 1, Day 1 pre-dose and through 12 hours postdose; Cycle 1 Day 7 pre-dose and through 48 hours post dose|The APaT population consisted of all participants who received at least one dose of study drug.|||Hours||Full Range|Median
2673160|NCT01463696|Secondary|Maximum Observed Plasma Concentration (Cmax) of MK-8242|PK plasma samples were to be collected at the following time points: 0, 0.5, 1, 2, 4, 6, 8,and 12 hours after the first dose on Day 1; and 0, 0.5, 1, 2, 4, 6, 8, 12, 24 (Day 8) and 48 (Day 9) hours post-dose on Day 7.|Cycle 1, Day 1 pre-dose and through 24 hours post dose; Cycle 1 Day 7 pre-dose and through 48 hours post dose|The All Participants as Treated (APaT) population consisted of all participants who received at least one dose of study drug.|||nM||Geometric Coefficient of Variation|Geometric Mean
2673173|NCT01463384|Primary|Hippocampal Volumes Measured in Three Groups: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI) and Normal, Age-matched Controls (NC).|"Using magnetic resonance images acquired, hippocampal volume was measured monthly for 6 months.~Normal range for hippocampal volume in aged-matched controls is 6.6 - 8.8 cm^3.~Values are reported below for Baseline, averaged for 1-3 months, and averaged for 4-6 months during minocycline administration."|Baseline values, 1-3 Months Values (averaged), 4-6 Months Values (averaged)||||cm^3||Standard Deviation|Mean
2673207|NCT01463202|Secondary|Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA|Use of DMPA, IUD, implant, or sterilization|6 months||||Participants|||Count of Participants
2673747|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|26 week follow up|||||||
2673161|NCT01463696|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLT was defined as: any drug-related hematologic toxicity ≥ Grade 3 lasting ≥1 week, ≥ Grade 3 thrombocytopenia with bleeding, ≥ Grade 3 neutropenia with infection OR non-hematologic DLTs that were any Grade 3, 4, or 5 toxicity with the following exceptions/clarifications: 1) Grade 3 nausea, vomiting, diarrhea, and dehydration were excluded from the determination of DLT if, in the opinion of the investigator and sponsor, they occurred in a setting of inadequate treatment, 2) Grade 3 nausea, vomiting, diarrhea, and dehydration were each considered a DLT if they persisted despite 72 hours of maximal supportive care measures or 3) Any abnormal non-hematological laboratory value ≥ Grade 3 (that is not attributable to any other causes) was considered a DLT only if medical intervention was required to treat the participant, the abnormality led to hospitalization, or the abnormality persisted for ≥1 week.|Cycle 1 (21 days)|The DLT-evaluable population consisted of participants who received at least one dose of MK-8242 and completed Cycle 1 of Part 1 (dose escalation) or the dose confirmation portion of Part 2, or discontinued due to toxicity.|||Participants|||Number
2673162|NCT01463683|Primary|Percentage of Participants With Pyrexia Adverse Events|Participants were evaluated for pyrexia adverse events using MedDRA version 15.1. Pyrexia (fever) was defined as an oral temperature ≥37.8°C ( ≥100.0°F).|Up to 15 days after each vaccination|All randomized participants who received at least 1 vaccination were included in the analysis|||Percentage of participants|||Number
2673163|NCT01463683|Primary|Percentage of Participants With Injection-site Adverse Events|Participants were evaluated for injection-site adverse events using MedDRA version 15.1|Up to 15 days after each vaccination|All randomized participants who received at least 1 vaccination were included in the analysis|||Percentage of participants|||Number
2673164|NCT01463683|Primary|Percentage of Participants Receiving Subcutaneous Vaccination Who Achieved Seroprotection|Blood samples were collected for anti-hepatitis B antibody assays. Seroprotection was defined as ≥10 mIU/mL anti-hepatitis B antibody.|Month 7|The per protocol population consisted of all randomized participants who met enrollment criteria, did not violate the protocol, were seronegative at Baseline, and had vaccination and blood collection. Seroprotection was evaluated only for participants receiving vaccine subcutaneously; intramuscular vaccination was evaluated for safety only.|||Percentage of participants|||Number
2673165|NCT01463631|Secondary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3007113||Cycle 1 Day -3 (single dose): Predose to 48 hours Postdose; Day 28 (multiple dose): Predose to 24 hours Postdose|Participants who received at least one dose of study drug and had sufficient evaluable Cmax values.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2673166|NCT01463631|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From 0 to Tau (AUC[0-tau]) of Multiple Dose LY3007113||Cycle 1 Days 28 and 29, Cycle 2 Day 1: Predose to 24 hours Postdose|Participants who received at least one dose of study drug and had sufficient evaluable AUC(0-tau) values.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2673167|NCT01463631|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-inf]) of Single Dose LY3007113||Cycle 1 Days -3, -2, -1, 1: Predose to 48 hours Postdose|Participants who received at least one dose of study drug and had sufficient evaluable AUC(0-inf) values.|||nanogram*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2673168|NCT01463631|Secondary|The Percentage of Participants Who Achieved a Best Response of Either Complete Response (CR) or Partial Response (PR): Overall Response Rate (ORR)|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR was defined as having at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter without notable worsening of additional tumors that were qualitatively assessed.|Baseline through Study Completion (up to 170 Days)|Participants in Part B who received at least one dose of study drug and were radiologically assessed for tumor response.|||percentage of participants|||Number
2673169|NCT01463631|Primary|Number of Participants With Clinically Significant Adverse Events (AEs) (Physical Assessments and Clinical Lab Tests)|Data presented are the number of participants who experienced at least one treatment emergent adverse event (TEAE). A TEAE is defined as an event that first occurred or worsened after randomization. A summary of serious AEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Baseline through Study Completion (up to 170 Days)|Participants who received at least one dose of study drug.|||Participants|||Count of Participants
2673170|NCT01463527|Secondary|Frequency of Hypoxia Defined as Pulse Oximetry Less Than 95%.|While there were 77 patients per group, each patient had vital signs measured every 30 seconds for the duration of their stay. This resulted in a variable amount of time points (data points) recorded per patient. Our event frequency was the number of events (outcome measure of abnormal vital signs) per number of time points for each patient. This is presented as an event rate.|Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)||||rate of total events/total time points|Total Number of Time Points per Group|Full Range|Mean
2673171|NCT01463527|Primary|Frequency of Staff Interventions for Hypoventilation.|These include verbal or physical stimulation, administration of supplemental oxygen, bag-valve mask ventilation, or use invasive airway devices.|Every 30 seconds during sedation; this is on average 30 minutes (range 10-240 minutes)||||Events per patient minute of sedation||Full Range|Mean
2673172|NCT01463384|Primary|Biomarker NAA/mI Measured in Three Groups: Alzheimer Disease (AD), Mild Cognitive Impairment (MCI) and Normal, Age-matched Controls (NC)|"It has been demonstrated in numerous studies over the past decade that magnetic resonance spectroscopy (MRS) can be used for the diagnosis of Alzheimer's disease. By measuring an area within the posterior cingulate gyrus, one can obtain a biochemical signature of that region in AD whereby NAA is reduced and mI is increased.~These two biomarkers, N-acetylaspartate (NAA, a neuronal marker) and myo-inositol (mI, a glial marker) were quantified and then used to calculate NAA/mI (an index currently widely used for AD and MCI diagnosis).~Scale of MRS biomarkers for aged-matched controls: NAA = 1.43, mI = 0.60, NAA/mI = 2.38. Any value lower than NAA/mI of 2.38 are considered not normal.~Values are reported below for Baseline, averaged for 1-3 months, and averaged for 4-6 months during minocycline administration."|Baseline values, 1-3 Months Values (averaged), 4-6 Months Values (averaged)||||Ratio||Standard Deviation|Mean
2673174|NCT01463384|Primary|Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)|"RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial skills. RBANS was developed as a stand-alone core battery for the detection and neurocognitive characterization of dementia and as a brief neurocognitive battery for the detection and tracking of neurocognitive deficits in a variety of disorders. (Reference: http://rbans.com/)~Qualitative Description of Index Scores:~Index Score Classification 130 and above Very Superior 120-129 Superior 110-119 High Average 90-109 Average 80-89 Low Average 70-79 Borderline 69 and below Extremely Low~Psychometric range for RBANS:~AD 0 - 77 MCI 78 - 99 Normal > 100~Range of scores: Minimum = 0, Maximum = 130~Values are reported below for Baseline, averaged for 1-3 months, and averaged for 4-6 months during minocycline administration."|Baseline values, 1-3 Months Values (averaged), 4-6 Months Values (averaged)||||units on a scale||Standard Deviation|Mean
2673175|NCT01463306|Primary|28-Days Seizure Rate at Month 12/Early Termination|28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.|Month 12/Early Termination|"Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows."|||Seizures Per 28-Days||Standard Deviation|Mean
2673176|NCT01463306|Secondary|Number of Participants as Per Reliable Change Index Category for Cogstate Pediatric Identification Task|"CogState brief battery consisted of 2 tasks-detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded yes using a response button with dominant hand. Participants had to respond as fast and as accurately as possible. Pediatric identification task: measured choice reaction time to assess visual attention. An event (a card turning face up) occurred in center of computer screen and participant decided if event met a predefined and unchanging criterion (is the color of the card black?); answered YES if criterion was met. A participant's RCI was calculated by dividing the change from individual baseline score by ([square root 2] times WSD),WSD=within-subject standard deviation from Cogstate task normative data. Improvement in cognition: RCI <=-1.65, decline in cognition: RCI =>1.65."|Month 12|"Analysis population included participants who took at least 1 dose of the study medication in the study and were evaluable for cognitive testing. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure."|||Participants|||Count of Participants
2673177|NCT01463306|Secondary|Number of Participants as Per Reliable Change Index (RCI) Category for Cogstate Detection Task|"CogState brief battery consisted of 2 tasks- detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded yes using a response button with dominant hand. Participants had to respond as fast and as accurately as possible. Detection task: measured simple reaction time to assess psychomotor function. Participant pressed a YES response key as soon as they detected an event (ie, a card turning face up presented in the center of the computer screen). A participant's RCI was calculated by dividing the change from individual baseline score by ([square root 2] times WSD), where WSD is within-subject standard deviation from Cogstate detection task normative data. Improvement in cognition when RCI <=-1.65, decline in cognition when RCI =>1.65."|Month 12|"Analysis population included participants who took at least 1 dose of the study medication in the study and were evaluable for cognitive testing. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure."|||Participants|||Count of Participants
2673178|NCT01463306|Secondary|Number of Participants With Suicidal Behavior as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA)|"Number of participants with C-CASA code 1 or 2 or 3 are reported. C-SSRS responses mapping to C-CASA suicidal behavior codes 1, 2, or 3 are as follows: (1) completed suicide; (2) suicide attempt (response of Yes on actual attempt); (3) preparatory acts toward imminent suicidal behavior (Yes on aborted attempt, interrupted attempt, preparatory acts or behavior)."|Baseline (Day 1), Post-baseline up to 12 Months|"Analysis population included participants who took at least 1 dose of the study medication in the study and with age >=6 years. Here, Number Analyzed signifies number of participants evaluable for specified rows."|||Participants|||Count of Participants
2673179|NCT01463306|Secondary|Number of Participants With Suicidal Ideation as Per Columbia Suicide Severity Rating Scale (C-SSRS) Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA)|"Number of participants with C-CASA code 4 are reported. C-SSRS responses mapping to C-CASA suicidal ideation code 4 are as follows: Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act, without specific plan, active suicidal ideation with some intent to act, without specific plan."|Baseline (Day 1), Post-baseline on Day 1 up to 12 Months|"Analysis population included participants who took at least 1 dose of the study medication in the study and with age >=6 years. Here, Number Analyzed signifies number of participants evaluable for specified rows."|||Participants|||Count of Participants
2673180|NCT01463306|Primary|28-Days Seizure Rate at Month 9|28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.|Month 9|"Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows."|||Seizures Per 28-Days||Standard Deviation|Mean
2673181|NCT01463306|Primary|28-Days Seizure Rate at Month 6|28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.|Month 6|"Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows."|||Seizures Per 28-Days||Standard Deviation|Mean
2673182|NCT01463306|Primary|28-Days Seizure Rate at Month 4|28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.|Month 4|"Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows."|||Seizures Per 28-Days||Standard Deviation|Mean
2673183|NCT01463306|Primary|28-Days Seizure Rate at Month 2|28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.|Month 2|"Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows."|||Seizures Per 28-Days||Standard Deviation|Mean
2673184|NCT01463306|Primary|28-Days Seizure Rate at Month 1|28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.|Month 1|"Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows."|||Seizures Per 28-Days||Standard Deviation|Mean
2673185|NCT01463306|Primary|28-Days Seizure Rate at Week 1|28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.|Week 1|"Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows."|||Seizures Per 28-Days||Standard Deviation|Mean
2673186|NCT01463306|Primary|Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters|Categories for which data is reported are: 1) maximum (max) PR interval increase from baseline (IFB) (millisecond [msec]) percent change (PctChg) >=25/50%; 2) maximum QRS complex increase from baseline (msec) PctChg>=50%; 3) maximum QTcB interval (Bazett's correction) increase from baseline (msec): change >=30 to <60; change >=60; 4) maximum QTcF interval (Fridericia's correction) increase from baseline (msec): change >=30 to <60; change >=60. 'PctChg>=25/50%': >= 25% increase from baseline when baseline ECG parameter is > 200 msec, and is >= 50% increase from baseline when baseline ECG parameter is non-missing and <=200 msec.|Baseline up to 12 Months|"Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure."|||Participants|||Count of Participants
2673187|NCT01463306|Primary|Number of Participants With Incidence of Laboratory Abnormalities|Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell(RBC) count: <0.8*lower limit of normal(LLN), platelet: <0.5*LLN/greater than (>)1.75*upper limit of normal (ULN), white blood cell (WBC): <0.6*LLN/>1.5*ULN, lymphocyte, neutrophil- absolute/%:<0.8*LLN/>1.2*ULN, basophil, eosinophil, monocyte- absolute/%:>1.2*ULN; total/direct/indirect bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:> 3.0*ULN, total protein, albumin: <0.8*LLN/>1.2*ULN; thyroxine, thyroid stimulating hormone <0.8*LLN/>1.2*ULN; cholesterol, triglycerides:> >1.3*ULN; blood urea nitrogen, creatinine:>1.3*ULN; sodium <0.95*LLN/>1.05*ULN, potassium, chloride, calcium: <0.9*LLN or >1.1*ULN; glucose <0.6*LLN/>1.5*ULN, creatine kinase>2.0*ULN; urine (specific gravity <1.003/>1.030, pH <4.5/>8, glucose, ketones, protein: >=1, WBC, RBC:>=20, bacteria >20, hyaline casts/casts >1); prothrombin (PT), PT international ratio>1.1*ULN.|Baseline up to 12 Months|Analysis population included participants who took at least 1 dose of the study medication in the study and were evaluable for laboratory abnormalities.|||Participants|||Count of Participants
2673188|NCT01463306|Primary|Absolute Values for Body Height at Month 12||Month 12|"Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure."|||Centimeters||Standard Deviation|Mean
2673189|NCT01463306|Primary|Absolute Values for Body Height at Baseline||Baseline|"Safety population included participants who took at least 1 dose of the study medication in the study. Here,Number Analyzed signifies number of participants evaluable for specified rows."|||Centimeters||Standard Deviation|Mean
2673190|NCT01463306|Primary|Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months|In this outcome measure number of participants with increase and decrease of >=7% in body weight, from baseline up to 12 months are reported.|Baseline up to 12 Months|"Safety population included participants who took at least 1 dose of the study medication in the study. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure."|||Participants|||Count of Participants
2673191|NCT01463306|Primary|Number of Participants With Tanner Staging Evaluation at Month 12|Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).|Month 12|"Analysis population included who took at least 1 dose of the study medication in the study and with age 4 years to less than 17 years. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows."|||Participants|||Count of Participants
2673192|NCT01463306|Primary|Number of Participants With Tanner Staging Evaluation at Baseline|Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).|Baseline (Day 1)|"Analysis population included who took at least 1 dose of the study medication in the study and with age 4 years to less than 17 years. Here, Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure and Number Analyzed signifies number of participants evaluable for specified rows."|||Participants|||Count of Participants
2673193|NCT01463306|Primary|Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities|Pre-defined criteria of vital signs abnormalities: maximum (max.) increase or decrease from baseline in sitting/supine systolic blood pressure (SBP) >=30 millimeter of mercury (mmHg); maximum increase or decrease from baseline in sitting/supine diastolic blood pressure (DBP) >=20 mmHg.|Baseline up to 12 months|Safety population included participants who took at least 1 dose of the study medication in the study.|||Participants|||Count of Participants
2673194|NCT01463306|Primary|Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months|Physical examination assessed: general appearance, dermatological, head and eyes, ears, nose, mouth, and throat, pulmonary, cardiovascular, abdominal, genitourinary (optional), lymphatic, musculoskeletal/extremities. Neurological examination assessed: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation, coordination and gait. Investigator judged clinically significant change from baseline in physical and neurological examination findings.|Baseline up to 12 Months|"Safety population included participants who took at least 1 dose of the study medication in the study. Here, Number Analyzed signifies number of participants evaluable for specified rows."|||Participants|||Count of Participants
2673195|NCT01463306|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 28 days after last dose of study drug (up to 13 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator.|Baseline (Day 1) up to 13 Months|Safety population included participants who took at least 1 dose of the study medication in the study.|||Participants|||Count of Participants
2673196|NCT01463293|Secondary|Adverse Event Frequency|All adverse events, regardless of relationship with investigational product, will be reported during the 4-week follow-up period.|4 weeks|||||||
2673197|NCT01463293|Secondary|Overall Product Satisfaction|At the end of the supplementation period, subjects will be asked to rate their overall satisfaction with the study product's ability to relieve their constipation symptoms on a 5-point ordinal scale|4 weeks|||||||
2673198|NCT01463293|Secondary|Stool Consistency|Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form|4 weeks|||||||
2673199|NCT01463293|Secondary|Bowel Movement Frequency|Subjects will record the number of defecations per day in a diary.|4 weeks|||||||
2673200|NCT01463293|Secondary|Adequate Relief of Constipation (Yes/no)|Adequate relief of constipation (yes/no) This (yes/no) questionnaire will be completed at days 0 and 28.|4 weeks|||||||
2673201|NCT01463293|Secondary|Bowel Function Index|The Bowel Function Index is a 3-question tool that asks subjects if they have experienced adequate relief of constipation symptoms over the past week. The Bowel Function Index will be completed at days 0 and 28.|4 weeks|||||||
2673202|NCT01463293|Secondary|Patient Assessment of Constipation QoL (PAC-QoL)|The PAC-QoL is a 28-question survey that asks questions on their quality of life.|4 weeks|||||||
2673203|NCT01463293|Secondary|Patient Assessment of Constipation Symptoms (PAC-SYM)|The PAC-SYM tool asks 12 questions on the symptoms of constipation. Subjects will complete the PAC-SYM at days 0 and 28.|4 weeks|||||||
2673204|NCT01463293|Primary|Whole Gut Transit Time|The primary endpoint of this clinical trial is whole gut transit time, which will be assessed using abdominal x-rays on days 0 and 28|4 weeks|Only 39 out of the 224 enrolled subjects consumed the radio-opaque markers in line with the protocol. Because of the substantial number of protocol deviations and the lack of sufficient evaluable subjects, no further analyses of the study data were performed. The study appears not to have yielded evaluable data.||||||
2673205|NCT01463202|Secondary|Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA|Exclusive breastfeeding at specific time intervals postpartum|2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum|Two participants withdrew during follow-up|||Participants|||Count of Participants
2673208|NCT01463202|Primary|Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA|Any breastfeeding at specific time intervals postpartum|2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum|1 ppt withdrawn postrandomization due to enrollment violation (did not meet eligibility criteria)|||Participants|||Count of Participants
2673209|NCT01463111|Secondary|Mean Difference in Barratt Impulsiveness Scale, Version 11 (BIS-11) Score|The BIS-11 is a 30 item self-report questionnaire, used to assess three factors of impulsivity: 1). attentional impulsiveness, reflecting a difficulty concentrating or tolerating cognitive complexity, 2). motor impulsiveness, reflecting a tendency to act before thinking, and 3). non-planing impulsiveness, reflecting a lack of forethought about potential consequences. Items are scored on a 4-point scale: Rarely/Never = 1 Occasionally = 2 Often = 3 Almost Always/Always = 4. Attentional impulsivity scores range from 8-32. Motor impulsivity scores range from 11-44. Non-planning impulsivity scores range from 11-44. Total BIS-11 scores range from 30-120. A higher score reflects higher impulsivity across all sub-types.|Baseline, Week 6|Data was analyzed for participants who completed all study visits. Means are age-adjusted.|||units on a scale||Standard Error|Mean
2673210|NCT01463111|Primary|Change in Procrastination Assessed by the Melbourne Decision Making Questionnaire (MDMQ)|"The MDMQ is a 22-item self report form assessing four different styles of decision making. The procrastination decision-making style involves putting off making decisions. Scores range from 0-10. A higher score indicates that the procrastination decision-making style is used more and is considered a worse score."|Baseline, Week 6|Data was analyzed for participants who completed all study visits. Means are age-adjusted.|||units on a scale||Standard Error|Mean
2673211|NCT01463111|Primary|Change in Buckpassing Assessed by the Melbourne Decision Making Questionnaire (MDMQ)|"The MDMQ is a 22-item self report form assessing four different styles of decision making. The buckpassing decision-making style represents a tendency to leave decisions to others. Scores range from 0-12. A higher score indicates that the buckpassing decision-making style is used more frequently and represents a worse score."|Baseline, Week 6|Data was analyzed for participants who completed all study visits. Means are age-adjusted.|||units on a scale||Standard Error|Mean
2673212|NCT01463111|Primary|Change in Hypervigilance Assessed by the Melbourne Decision Making Questionnaire (MDMQ)|"The MDMQ is a 22-item self report form assessing four different styles of decision making. Hypervigilance is marked by hurried, anxious decision-making. Scores range from 0-10. A higher score indicates a worse score and that a hyper-vigilant decision making style is used more frequently."|Baseline, Week 6|Data was analyzed for participants who completed all study visits. Means are age-adjusted.|||units on a scale||Standard Error|Mean
2673213|NCT01463111|Primary|Change in Vigilance Assessed by the Melbourne Decision Making Questionnaire (MDMQ)|The MDMQ is a 22-item self report form assessing four different styles of decision making. Vigilance is considered the healthy, adaptive, decision-making style, reflecting consideration of an array of outcomes and ultimately rational decision-making. Scores range from 0-12. A higher score indicates that vigilance is used more frequently during decision making. A higher score indicates healthier decision making.|Baseline, Week 6|Data was analyzed for participants who completed all study visits. Means are age-adjusted.|||units on a scale||Standard Error|Mean
2673214|NCT01463098|Secondary|Part B: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess any suicidality, any suicidal Behavior, any suicidal ideation. Any suicidality: emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior: when response is yes for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious, behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: when response is yes for any of these questions-wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. Number of participants with any suicidality has been reported for this outcome measure."|Baseline, Day 11|Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.|||Participants|||Count of Participants
2673215|NCT01463098|Secondary|Part B: Number of Participants With Clinically Significant Change From Baseline in ECG Parameter Values||Baseline up to Day 11|Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.|||Participants|||Count of Participants
2673216|NCT01463098|Secondary|Part B: Number of Participants With Significant Change From Baseline in Vital Sign Values||Baseline up to Day 11|Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.|||Participants|||Count of Participants
2673217|NCT01463098|Secondary|Part B: Number of Participants With Markedly Abnormal Laboratory Parameter Values||Baseline up to Day 6|Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.|||Participants|||Count of Participants
2673218|NCT01463098|Secondary|Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)||Baseline up to Day 11|Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.|||Participants|||Count of Participants
2673219|NCT01463098|Secondary|Part A: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6|"Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question Rate quality of your sleep has been reported."|Day 1, Day 6|"PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here number analyzed” signifies participants who were evaluable for the outcome measure at given time points."|||score on a scale||Standard Deviation|Mean
2673228|NCT01463098|Secondary|Part A: Cumulative Amount of Unchanged Drug E2006 Excreted Into the Urine (Ae)||Day 1: Pre-dose, up to 120 hours post-dose|PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.|||milligram (mg)||Geometric Coefficient of Variation|Geometric Mean
2673220|NCT01463098|Secondary|Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6|"Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question Time spent awake after falling asleep has been reported."|Day 1, Day 6|"PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here number analyzed signifies participants who were evaluable for the outcome measure at given time points."|||minutes||Standard Deviation|Mean
2673221|NCT01463098|Secondary|Part A: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6|"Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question Number of awakening after falling asleep has been reported."|Day 1, Day 6|"PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here number analyzed” signifies participants who were evaluable for the outcome measure at given time points."|||number of awakenings||Standard Deviation|Mean
2673222|NCT01463098|Secondary|Part A: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6|"Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question Time to fall asleep last night has been reported."|Day 1, Day 6|"PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here number analyzed” signifies participants who were evaluable for the outcome measure at given time points."|||minutes||Standard Deviation|Mean
2673223|NCT01463098|Secondary|Part A: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6|"Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm a lack of sleep disturbance. In this outcome measure, data for question How long did you sleep last night has been reported."|Day 1, Day 6|"PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here number analyzed” signifies participants who were evaluable for the outcome measure at given time points."|||minutes||Standard Deviation|Mean
2673224|NCT01463098|Secondary|Part A: Maximum Change From Day 1 (Pre-dose) in Karolinska Sleepiness Scale (KSS) Score at Day 6|"KSS is a 9-point scale, on which the participant has to mark his or her sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 9, which indicates extremely sleepy, can't stay awake. Higher numbers indicating sleepier and lower numbers more alert. In this outcome measure, data for participants who received placebo matched to 1 mg, 2.5 mg, 5 mg E2006 and matched to 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006, has been presented separately."|Day 1 (Pre-dose), Day 6|"PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here number analyzed” signifies participants who were evaluable for this outcome measure at given time points."|||score on a scale||Standard Deviation|Mean
2673225|NCT01463098|Secondary|Part A: Maximum Change From Day 1 (Pre-dose) in Number of Lapses of > 500 Msec Assessed by Psychomotor Vigilance Test (PVT) at Day 6|"PVT, a computer-based test, is a chronometric measure of an individual's reaction to specified small changes in a labile environment. Participants were instructed to respond to a digital signal on a computer terminal by pressing a key. Errors of omission and commission are recorded. When a participant did not respond to the PVT signal within 500 msec, it was termed a lapse. The higher the number of lapses the greater the impairment. In this outcome measure, data for participants who received placebo matched to 1 mg, 2.5 mg, 5 mg E2006 and matched to 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006, has been presented separately."|Day 1 (Pre-dose), Day 6|"PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here number analyzed” signifies participants who were evaluable for this outcome measure at given time points."|||lapses||Standard Deviation|Mean
2673226|NCT01463098|Secondary|Part A: Maximum Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6|"DSST is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the participant to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than cognitive functioning) to 133 (greater than cognitive functioning) as a description of DSST. An increase in score represents an improvement in an integrated measure of cognitive function. In this outcome measure, data for participants who received placebo matched to 1 mg, 2.5 mg, 5 mg E2006 and matched to 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg E2006, has been presented separately."|Day 1 (Pre-dose), up to Day 6|"PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here number analyzed” signifies participants who were evaluable for this outcome measure at given time points."|||score on a scale||Standard Deviation|Mean
2673227|NCT01463098|Secondary|Part A: Renal Clearance (CLR) of Drug E2006||Day 1: Pre-dose, up to 120 hours post-dose|PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.|||milliliter per minute (mL/min)||Geometric Coefficient of Variation|Geometric Mean
2673748|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|12 week follow up|||||||
2673229|NCT01463098|Secondary|Part A: Apparent Volume of Distribution of E2006 in Plasma (Vz/F)||Day 1: Pre-dose, up to 240 hours post-dose|PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.|||liter (L)||Geometric Coefficient of Variation|Geometric Mean
2673230|NCT01463098|Secondary|Part A: Apparent Total Clearance of E2006 From Plasma (CL/F)||Day 1: Pre-dose, up to 240 hours post-dose|PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.|||liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2673231|NCT01463098|Secondary|Part A: Terminal Half-life (t1/2) of E2006 in Plasma||Day 1: Pre-dose, up to 240 hours post-dose|PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.|||hours||Full Range|Median
2673232|NCT01463098|Secondary|Part A: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of E2006||Day 1: Pre-dose, up to 240 hours post-dose|"PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis. Here overall number of participants analyzed signifies participants who were evaluable for this outcome measure."|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2673233|NCT01463098|Secondary|Part A: Area Under the Plasma Concentration-time Curve From Time Zero to t Hours (AUC0-t) of E2006||Day 1: Pre-dose, up to 240 hours post-dose|PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2673234|NCT01463098|Secondary|Part A: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) of E2006||Day 1: Pre-dose, up to 240 hours post-dose|PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameter for Part B were not analyzed due to change in planned analysis.|||nanogram hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2673235|NCT01463098|Secondary|Part A: Time to Reach Maximum Plasma Concentration (Tmax) of E2006||Day 1: Pre-dose, up to 240 hours post-dose|PK analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.|||hours||Full Range|Median
2673236|NCT01463098|Secondary|Part A: Maximum Plasma Concentration (Cmax) of E2006||Day 1: Pre-dose, up to 240 hours post-dose|Pharmacokinetic (PK) analysis set included all participants who had sufficient PK data to derive at least one PK parameter. PK parameters for Part B were not analyzed due to change in planned analysis.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2673237|NCT01463098|Primary|Part B: Change From Day 1 (Pre-dose) in Score on Karolinska Sleepiness Scale (KSS) at Day 6|"KSS is a 9-point scale, on which the participant has to mark his or her sleepiness during the previous 10 minutes. The scale ranges from 1, which indicates extremely alert, to 9, which indicates extremely sleepy, can't stay awake. Higher numbers indicating sleepier and lower numbers more alert."|Day 1 (Pre-dose), Day 6|PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.|||score on a scale||Standard Deviation|Mean
2673238|NCT01463098|Primary|Part B: Change From Day 1 (Pre-dose) in Number of Lapses of Greater Than (>) 500- Milliseconds (Msec) Assessed by Psychomotor Vigilance Test (PVT) at Day 6|PVT, a computer-based test, is a chronometric measure of an individual's reaction to specified small changes in a labile environment. Participants were instructed to respond to a digital signal on a computer terminal by pressing a key. Errors of omission and commission are recorded. When a participant did not respond to the PVT signal within 500 msec, it was termed a lapse. The higher the number of lapses the greater the impairment.|Day 1 (Pre-dose), Day 6|"PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter. Here number analyzed signifies participants who were evaluable for this outcome measure at given time points."|||lapses||Standard Deviation|Mean
2673239|NCT01463098|Primary|Part B: Change From Day 1 (Pre-dose) in Digit Symbol Substitution Test (DSST) Score at Day 6|DSST is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the participant to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than cognitive functioning) to 133 (greater than cognitive functioning) as a description of DSST. An increase in score represents an improvement in an integrated measure of cognitive function.|Day 1 (Pre-dose), Day 6|PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.|||score on a scale||Standard Deviation|Mean
2673240|NCT01463098|Primary|Part B: Change From Day 1 in Waketime Questionnaire Parameters: Rate Quality of Your Sleep at Day 6|"Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question Rate quality of your sleep has been reported."|Day 1, Day 6|PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.|||score on a scale||Standard Deviation|Mean
2673241|NCT01463098|Primary|Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time Spent Awake After Falling Asleep at Day 6|"Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question Time spent awake after falling asleep has been reported."|Day 1, Day 6|PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.|||minutes||Standard Deviation|Mean
2673749|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|5 weeks (or after treatment session 10)|||||||
2673242|NCT01463098|Primary|Part B: Change From Day 1 in Waketime Questionnaire Parameters: Number of Awakening After Falling Asleep at Day 6|"Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question Number of awakening after falling asleep has been reported."|Day 1, Day 6|PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.|||number of awakenings||Standard Deviation|Mean
2673243|NCT01463098|Primary|Part B: Change From Day 1 in Waketime Questionnaire Parameters: Time to Fall Asleep Last Night at Day 6|"Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question Time to fall asleep last night has been reported."|Day 1, Day 6|PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.|||minutes||Standard Deviation|Mean
2673244|NCT01463098|Primary|Part B: Change From Day 1 in Waketime Questionnaire Parameters: How Long Did You Sleep Last Night at Day 6|"Participants were asked to answer the following question using Waketime Questionnaire: How long did you sleep last night, number of awakening after falling asleep, time to fall asleep last night, time spent awake after falling asleep, rate quality of your sleep (using Likert scale, ranged from 0 = very sound or restful, to 4 = very restless where lower score indicates better outcome). The primary purpose of the Waketime Questionnaire was to confirm anticipated reports of poor sleep. In this outcome measure, data for question How long did you sleep last night has been reported."|Day 1, Day 6|PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.|||minutes||Standard Deviation|Mean
2673245|NCT01463098|Primary|Part B: Change From Baseline in Mean Total Number of Shift in Sleep Stages Assessed Using PSG at Day 1|Sleep stages included NREM sleep and REM (dreaming) sleep. Non-REM sleep is comprised of the sum of Stage N1 (light sleep), N2 (also fairly light, with sudden increases in brain wave frequency known as sleep spindles) and N3 or slow wave sleep (deep sleep). Sleep was staged in sequential 30-second epochs.|Baseline, Day 1|PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.|||stage shift||Standard Deviation|Mean
2673246|NCT01463098|Primary|Part B: Change From Baseline in Duration (in Minutes) of Each Sleep Stage Assessed Using PSG at Day 1|Sleep stages included NREM sleep and REM (dreaming) sleep. Non-REM sleep is comprised of the sum of Stage N1 (light sleep), N2 (also fairly light, with sudden increases in brain wave frequency known as sleep spindles) and N3 or slow wave sleep (deep sleep). Sleep was staged in sequential 30-second epochs.|Baseline, Day 1|PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.|||minutes||Standard Deviation|Mean
2673247|NCT01463098|Primary|Part B: Change From Baseline in Percentage of Each Sleep Stage Duration Assessed Using PSG at Day 1|Sleep stages included NREM sleep and REM (dreaming) sleep. Non-REM sleep is comprised of the sum of Stage N1 (light sleep), N2 (also fairly light, with sudden increases in brain wave frequency known as sleep spindles) and N3 or slow wave sleep (deep sleep). Sleep was staged in sequential 30-second epochs.|Baseline, Day 1|PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.|||percentage of sleep stage duration||Standard Deviation|Mean
2673248|NCT01463098|Primary|Part B: Change From Baseline in Number of Awakenings After Persistent Sleep (NAW) Assessed Using PSG at Day 1|Number of awakenings was determined from LPS to lights-on. LPS was the duration of time measured from lights off to the first 30 seconds of PSG measurement recording (epoch) of 20 consecutive epochs of non-wake. An awakening was defined as a PSG recording of at least two consecutive wake epochs.|Baseline, Day 1|PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.|||awakenings||Standard Deviation|Mean
2673249|NCT01463098|Primary|Part B: Change From Baseline in Wake After Sleep Onset (WASO) Assessed Using PSG at Day 1|WASO was defined as the duration (in minutes) of wakefulness from onset of persistent sleep to lights-on.|Baseline, Day 1|PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.|||minutes||Standard Deviation|Mean
2673250|NCT01463098|Primary|Part B: Change From Baseline in Sleep Efficiency Assessed Using PSG at Day 1|Sleep efficiency was defined as the TST divided by the time in bed (minutes) multiplied by 100. TST was the duration in minutes including REM sleep plus NREM sleep during the time spent in bed.|Baseline, Day 1|PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.|||percentage of time asleep||Standard Deviation|Mean
2673251|NCT01463098|Primary|Part B: Change From Baseline in Total Sleep Time (TST) Assessed Using PSG at Day 1|TST was the duration in minutes including rapid eye movement (REM) sleep plus non-rapid eye movement (NREM) sleep during the time spent in bed.|Baseline, Day 1|PD analysis set included all participants who had sufficient PD data to derive at least one PD parameter.|||minutes||Standard Deviation|Mean
2673252|NCT01463098|Primary|Part B: Change From Baseline in Latency to Persistent Sleep (LPS) Assessed Using Polysomnography (PSG) Measurement at Day 1|LPS was the duration of time in minutes from lights off to the first 30 seconds of recording (epoch) of 20 consecutive epochs of non-wakefulness as measured by PSG.|Baseline, Day 1|Pharmacodynamic (PD) analysis set included all participants who had sufficient PD data to derive at least one PD parameter.|||minutes||Standard Deviation|Mean
2673267|NCT01462929|Primary|Change From Baseline in Normalised Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve Over the 24-h Period After 6 Weeks of Treatment|Change from baseline in normalised FEV1 area under the curve over the 24-h period immediately after morning Investigational Medicinal Product administration (AUC0-24h ) after 6 weeks on treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.|Week 6|Intention to treat (ITT) population: patients who took at least 1 dose of Investigational Medicinal Product and had at least a baseline FEV1 assessment and at least one post-baseline FEV1 value|||Liters||Standard Error|Least Squares Mean
2673253|NCT01463098|Primary|Part A: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess any suicidality, any suicidal behavior, any suicidal ideation. Any suicidality: emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior: when response is yes for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: when response is yes for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. Number of Participants with any suicidality has been reported for this outcome measure."|Baseline, Day 11|Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.|||Participants|||Count of Participants
2673254|NCT01463098|Primary|Part A: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameter Values||Baseline up to Day 11|Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.|||Participants|||Count of Participants
2673255|NCT01463098|Primary|Part A: Number of Participants With Significant Change From Baseline in Vital Sign Values||Baseline up to Day 11|Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.|||Participants|||Count of Participants
2673256|NCT01463098|Primary|Part A: Number of Participants With Markedly Abnormal Laboratory Parameter Values||Baseline up to Day 6|Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.|||Participants|||Count of Participants
2673257|NCT01463098|Primary|Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)||Baseline up to Day 11|Safety analysis set included all participants who received study drug and had at least one postdose safety assessment.|||Participants|||Count of Participants
2673258|NCT01463033|Secondary|Adverse Events|The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period.|30 day treatment period|The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Symptoms reported to be moderate or severe are listed. Adverse events were not monitored for the Observational group.|||Events|||Number
2673259|NCT01463033|Primary|Post-Traumatic Epilepsy|occurrence of PTE (Post-Traumatic Epilepsy)|2 years||||participants|||Number
2673260|NCT01463007|Secondary|Cosmetic Outcome|Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist using the Harvard criteria inclusive of discomfort during treatment(Pain), Fatigue and Acute skin reaction. This is reported in the outcome table.|2 years||||participants|||Number
2673261|NCT01463007|Primary|Early and Intermediate Toxicity|Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table.|2 years||||participants|||Number
2673262|NCT01462942|Secondary|Change From Baseline in St. George´s Respiratory Questionnaire (SGRQ) Total Score|SGRQ is a standardised, self-administered tool for measuring impaired health and perceived well-being in respiratory diseases; a validated electronic version of the questionnaire in the relevant validated languages was used in this study The questionnaire contains 50 items divided into three dimensions (Symptoms, Activity and Impact) Each of the three dimensions of the questionnaire is scored separately in the range from 0 to 100: zero (0) score indicating no impairment of quality of life The total SGRQ score ranging from 0 to 100 is a summary score utilising responses to all items calculated using weights attached to each item of the questionnaire Higher scores indicate poorer health and change of 4 units in the SGRQ has been determined to be the threshold for a clinically relevant change in health status|Baseline and Week 24||||Score on a scale||Standard Error|Least Squares Mean
2673263|NCT01462942|Secondary|Change in Transition Dyspnoea Index (TDI) Focal Score|Evaluation of dyspnea was performed by an independent interviewer experienced in taking a respiratory history The TDI includes three categories: functional impairment which determines the impact of breathlessness on the ability to perform activities, magnitude of task which determines the type of task that caused breathlessness and magnitude of effort which establishes the level of effort needed to evoke breathlessness Each category ranges from minus three (-3; major deterioration) to plus three (+3; major improvement) including a zero (0) score to indicate 'no change' The three categories are totalled to obtain a focal score (total score) ranging from minus nine (-9), including zero (0), to plus nine (+9) Provision is made for circumstances when dyspnoea could not be rated - if reduction of activities, effort or functional impairment was caused by reasons other than respiratory A change of 1 unit in TDI is used as the criterion for a minimal meaningful improvement|Baseline and Week 24||||Score on a scale||Standard Error|Least Squares Mean
2673264|NCT01462942|Primary|Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)||Baseline and Week 24||||Liters||Standard Error|Least Squares Mean
2673265|NCT01462942|Primary|Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)||Baseline and Week 24|ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment|||Liters||Standard Error|Least Squares Mean
2673266|NCT01462929|Secondary|Change From Baseline in Normalised FEV1 Area Under the Curve Over the 12-h Night-time Period After 6 Weeks of Treatment|Change from baseline in normalised FEV1 area under the curve over the 12-h night-time period (AUC12-24) after 6 weeks of treatment. The normalised AUC were calculated by means of a trapezoidal method, dividing by the corresponding time interval.|Week 6|Intention to treat (ITT) population: patients who took at least 1 dose of Investigational Medicinal Product and had at least a baseline FEV1 assessment and at least one post-baseline FEV1 value|||Liters||Standard Error|Least Squares Mean
2673268|NCT01462877|Secondary|Change in Serum High Sensitivity C-reactive Protein|Blood tests|Baseline and up to 8 weeks after intervention|||||||
2673280|NCT01462812|Primary|Headache Relief|The primary objective for this study is to compare headache relief (defined as a reduction from moderate [Grade 2] or severe [Grade 3] pain to none [Grade 0] or mild [Grade 1] pain) at 120 minutes following a dose of 20 mg of OPTINOSE SUMATRIPTAN with placebo in the acute treatment of a single migraine attack.|120 Minutes|The full analysis dataset (FAD) will include all subjects who are randomized, receive study medication, and record at least one post-treatment assessment of pain severity. The treatment group assignment will be designated according to treatment received. The FAD will serve as the basis for the efficacy analyses.|||participants|||Number
2673281|NCT01462773|Secondary|Document Any Objective Anti-tumor Responses and Time to Tumor Progression That May Occur in Response to This Treatment Regimen.|"Measure levels of the cell cycle proteins p21 and p27 in PBMCs and tumor biopsies obtained pre-study and during week 4 of Cycle 1 (Day 26).~Conduct histologic evaluations of microvessel density, tumor apoptosis and lymphocytic infiltrates within tumor biopsies obtained pre- and post-study.~Measure plasma levels of bFGF and VEGF over the course of the study.~Monitor the effects of proteasome inhibition on the biological activity of IFN-α within immune cells by measuring Jak-STAT signal transduction in patient PBMCs."|up to 25 weeks||||patients|||Number
2673282|NCT01462773|Primary|Determine Dose Limiting Toxicities (DLTs) of VELCADE When Administered in Combination With IFN-α-2b to Patients With Metastatic Malignant Melanoma.|A standard method for the design of this study. Initially, three patients will be treated at a starting dose of VELCADE (1.0 mg/m2). If one of the three patients demonstrates a DLT, then an additional 3 patients will be treated at that dose level. If only one of the six show DLT, then the next cohort of three patients will be entered at the next dose level (1.3 mg/m2). If two or more of the six demonstrate DLT, no further patients will be treated at that dose level. The highest dose level at which less than 2 patients experienced DLT will be expanded to six patients.|up to 25 weeks or until disease progression||||toxicities|||Number
2673283|NCT01462695|Primary|Sustained Objective Response Rate|Sustained objective response was defined as a PR (Partial Response: ≥ 50% decrease in the sum of the products of the 2 perpendicular diameters of all target lesions (up to 5), taking as reference the initial baseline measurements) or CR (Complete Response: disappearance of all target lesions) lasting at least 8 weeks.|Up to 5 years|One patient in Stratum A was excluded because the patient did not receive study drug and therefore was not evaluable for response.|||percentage of patients||95% Confidence Interval|Number
2673284|NCT01462565|Secondary|Number of Participants With Urine Pregnancy Test Positive|Urine samples were collected for urine pregnancy test. Urine samples were collected at up to the treatment follow up (1 week after Visit 3 [Week 4]). Number of participants with urine pregnancy test positive has been reported.|up to the treatment follow up (1 week after Visit 3 [Week 4])|ITT population. Only those participants with data available at the indicated time point were analyzed.|||Participants|||Count of Participants
2673285|NCT01462565|Secondary|Mean Oxygen Saturation in Blood Over Time|Pulse oximetry (oxygen saturation) was analyzed. Data for Pulse oximetry (oxygen saturation) was analyzed up to the treatment follow up (1 week after Visit 3 [Week 4]).|up to the treatment follow up (1 week after Visit 3 [Week 4])|ITT population. Only those participant available at the indicated time points were analyzed.|||Percentage of oxygen in blood||Standard Deviation|Mean
2673286|NCT01462565|Secondary|World Health Organization [WHO] Functional Class at Baseline and After 4- Weeks of Treatment|World Health Organization functional class was analyzed as class I, class II, class III and class IV. World Health Organization functional class was analyzed at Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4. The classed were defined as Class I: No symptoms of pulmonary arterial hypertension with exercise or at rest, Class II: No symptoms at rest but uncomfortable and short of breath with normal activity, Class III: May not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting and Class IV: Symptoms at rest and severe symptoms with any activity. Hence the severity increased from class I (better) to Class IV (worse).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4|ITT population. Only those participants with data available at the specified time point were analyzed.|||Participants|||Count of Participants
2673287|NCT01462565|Secondary|Breathlessness After 6MWD - Borg Dyspnoea Index (BDI)|The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. The BDI scale was assessed by each participant. Change from Baseline = score at observation minus score at Baseline. Baseline visit was Visit 2 i.e. Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4|ITT population.|||Score on a scale||Standard Deviation|Mean
2673288|NCT01462565|Secondary|Change From Baseline in Six Minute Walk Distance Test (6MWD) After 4-weeks of Treatment|This assessment was a non-encouraged test that measures the distance walked for a duration of 6 minutes. Change from Baseline was calculated as value at observation minus value at Baseline. Baseline visit was Visit 2 i.e. Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4|ITT population.|||meters||Standard Deviation|Mean
2673289|NCT01462565|Secondary|Number of Participants With Abnormal Urinalysis|Dipstick method was used to measure blood, glucose and protein. Data was analyzed up to 1 week after Week 4 (Follow-up visit).|Up to 1 week after Week 4 (Follow-up)|ITT population.|||Participants|||Count of Participants
2673290|NCT01462565|Secondary|Number of Participants With Abnormal Hematology|Values for hemoglobin, hematocrit, and platelet count were analyzed. Participants with abnormal values have been reported. The low and high value concern were as follows: hemoglobin (Males < 98, >180.0) (females <91, >161.0)grams per litre (g/L); hematocrit (Males < 32.0, >54.0) (females <29.0, >50.6) fraction (1); platelet count (< 100, > 500) gram international units per litre (gI/L).|Up to 1 week after Week 4 (Follow-up)|ITT population. Only those participant available at the indicated time points were analyzed.|||Participants|||Count of Participants
2673291|NCT01462565|Secondary|Number of Participants With Abnormal Clinical Chemistry|Abnormal clinical chemistry was analyzed as follows: serum alanine aminotransferase (ALT/SGPT) >= 3 x upper limit of normal (ULN) , aspartate aminotransferase (AST/SGOT) >= 3 x ULN , total bilirubin >= 34.2, creatinine >= 176.8.|Up to 1 week after Week 4 (Follow-up)|ITT population.|||Participants|||Count of Participants
2673292|NCT01462565|Secondary|Change From Baseline in Vital Signs at Week 4: Heart Rate|Summary mean change in heart rate measured in beats per minute (beats/min or BPM). Change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. Baseline was Visit 2 i.e. Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4|ITT population.|||beats/min||Standard Deviation|Mean
2673293|NCT01462565|Secondary|Change From Baseline in Vital Signs at Week 4 : Systolic and Diastolic Blood Pressure|Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. Baseline was Visit 2 i.e. Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4(Visit 3)|ITT population.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2673294|NCT01462565|Secondary|Number of Participants With Infusion Site Reactions During Treatment Period|Infusion site reactions were reported during the treatment period. Infusion site was inspected for erythema, excoriation, induration, skin necrosis or signs of local sepsis.|Baseline visit (Visit 2) to Week 4 (Visit 3)|ITT population.|||Participants|||Count of Participants
2673295|NCT01462565|Secondary|Number of Participants With Any Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events(SAEs)|An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, congenital anomaly/birth defect and medically significant and all events of possible drug-induced liver injury with hyperbilirubinaemia. Only treatment emergent AEs and SAEs were reported in this outcome measure. Specifically, this study reported 2 SAEs, but only 1 was categorized as treatment emergent.|Up to visit 3 (Week 4)|ITT population.|||Participants|||Count of Participants
2673296|NCT01462565|Primary|Change From Baseline in Dose of Thermo Stable Epoprostenol Sodium at Week 4|Dose titration requirement was assessed at the time of discharge. Change from Baseline was calculated as score at observation minus score at Baseline. Units- nanogram per kilogram per minute (ng/kg/min). Baseline was Visit 2 i.e . Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4|ITT population.|||ng/kg/min||Standard Deviation|Mean
2673297|NCT01462565|Primary|Change From Baseline in Study Specific Participant Acceptance Survey|Study-specific questionnaire comprised the pre-defined15 questions which included activities of daily living assessment. Participants rated the question on a scale of 1 to 10, where 1 was do not agree and 10 was strongly agree. Change from Baseline was calculated as score at observation minus score at Baseline. Changes from Baseline was assessed for Questions 2 to 12. Baseline was defined as Visit 2 i.e. Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3).|ITT population.|||Score on a scale||Standard Deviation|Mean
2673298|NCT01462565|Primary|Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36)|Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores was considered as better health status. Change from Baseline was calculated as score at observation minus score at baseline. Baseline was defined as Visit 2 i.e. Day-14 (+ or - 7 days).|Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3)|Intent-to-Treat (ITT) population consisted of all participants who received at least one dose of epoprostenol sodium during the Run-in period (either currently marketed epoprostenol sodium or the study drug).|||Score on a scale||Standard Deviation|Mean
2673299|NCT01462435|Secondary|TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 192 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 48 hours||||units on a scale*hour||Standard Deviation|Mean
2673300|NCT01462435|Secondary|TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 96 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 24 hours||||units on a scale*hour||Standard Deviation|Mean
2673301|NCT01462435|Secondary|TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 32 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 8 hours||||units on a scale*hour||Standard Deviation|Mean
2673750|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|2.5 weeks (or after treatment session 5)|||||||
2673302|NCT01462435|Secondary|Total Pain Relief (TOTPAR) Over 0 to 4 Hours. TOTPAR-4.|"Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked How much relief have you had since your starting pain? with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.~The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight.The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 16 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0."|0 - 4 hours||||units on a scale*hour||Standard Deviation|Mean
2673303|NCT01462435|Secondary|VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 24 hours||||mm*hour||Standard Deviation|Mean
2673304|NCT01462435|Secondary|VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 8 hours||||mm*hour||Standard Deviation|Mean
2673305|NCT01462435|Secondary|VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 4 hours||||mm*hour||Standard Deviation|Mean
2673306|NCT01462435|Primary|The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48), ANCOVA Model.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Possible Pain.~The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment."|0 - 48 hours|Intent-to-Treat Population|||mm*hour||Standard Deviation|Mean
2673307|NCT01462370|Secondary|Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 24 Hours After the Initial Dose|At 24 hours following the initial dose of study medication, participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 24 hours post initial dose were summed.|24 Hours|The population consisted of all participants that received at least one dose of study treatment and completed the assessment at 24 hours post initial dose of study medication|||Participants|||Number
2673308|NCT01462370|Secondary|Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 6 Hours After the Initial Dose|At 6 hours following the initial dose. participants were asked to rate their perception of pain control as poor, fair, good, very good, or excellent. The number of participants that reported good, very good, or excellent pain control at 6 hours post initial dose were summed.|6 hours|The population consisted of all participants that received at least one dose of study treatment and completed the assessment at 6 hours post initial dose of study medication.|||Participants|||Number
2673309|NCT01462370|Secondary|PR at Up to 24 Hours Following the Initial Dose|PR during the 24 hours following the initial dose is defined as the maximum PR score recorded during the first 24 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.|Up to 24 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one PR observation at up to 24 hours post initial dose of study medication.|||Score on a Scale||Standard Error|Least Squares Mean
2673310|NCT01462370|Secondary|PID at Up to 24 Hours Following the Initial Dose|PID during the 24 hours following the initial dose is defined as the maximum PID score recorded during first 24 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 20 and 24 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one PID observation up to 24 hours post initial dose of study medication.|||Score on a Scale||Standard Error|Least Squares Mean
2673322|NCT01462357|Secondary|Number of Subjects Using a Concomitant Medication Throughout the Study Period|The number of subjects who have used any concomitant medication, as well as any antipyretic, any prophylactic antipyretic and any antibiotic.|From Day 0 up to Month 36 (throughout the study period) following vaccination after each dose and across doses|The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.|||Participants|||Count of Participants
2673311|NCT01462370|Secondary|PR at Up to 12 Hours Following the Initial Dose|PR during the 12 hours following the initial dose is defined as the maximum PR score recorded during the first 12 hours after the initial dose of study medication. PR is evaluated on a scale of 0 to 4, with 0 = no pain relief, 1= a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.|Up to 12 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one PR observation up to 12 hours post initial dose of study medication.|||Score on a Scale||Standard Error|Least Squares Mean
2673312|NCT01462370|Secondary|PID at Up to 12 Hours Following the Initial Dose|PID during the 12 hours following the initial dose is defined as the maximum PID score recorded during first 12 hours after the initial dose of study medication. PID is evaluated on a scale from 0 to 3, with 0 = no pain, 1 = slight pain, 2 = moderate pain, and 3 = severe pain.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 and 12 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one PID observation at up to 12 hours post initial dose of study medication.|||Score on a Scale||Standard Error|Least Squares Mean
2673313|NCT01462370|Secondary|Number of Participants Using Rescue Medication 24 Hours After the Initial Dose|Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg (Saridon) was provided to each participant as rescue medication. Participants were permitted to take 2 tablets at a time and up to 3 doses within 24 hours of dosing of study drug for rescue purposes.|24 Hours|Due to the low number of participants requiring rescue medication use, the time to rescue medication use was not calculated.|||Participants|||Number
2673314|NCT01462370|Secondary|Peak Pain Relief (Peak PR) During the 6 Hours After the Initial Dose|"Peak PR during the 6 hours post initial dose is defined as the maximum PR score~recorded during the first 6 hours after the initial dose of study medication. PR is recorded on a scale of 0 to 4, with 0 = no pain relief, 1 = little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief."|Up to 6 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one Peak PR observation up to 6 hours post initial dose of study medication.|||Score on a Scale||Standard Error|Least Squares Mean
2673315|NCT01462370|Secondary|Peak Pain Intensity Difference (PID) During the 6 Hours After the Initial Dose|Peak PID during the 6 hours post initial dose is defined as the maximum PID score recorded during first 6 hours after the initial dose of study medication. PID is evaluated on a scale of -1 to 3, with larger values representing a greater treatment effect.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours|The population consisted of all participants that received at least one dose of study treatment and had a PID observation at up to 6 hours post initial dose of study medication.|||Score on a Scale||Standard Error|Least Squares Mean
2673316|NCT01462370|Secondary|Mean Time to >=1 Unit Improvement From Baseline in Pain Intensity During the 6 Hours After the Initial Dose|The time to a change from baseline in pain intensity score of >=1 unit on the pain intensity scale was calculated. The pain intensity scale rates participant pain on a scale of -1 to 3, with larger values associated with greater treatment effect.|Baseline and 6 hours|The population consisted of all participants that received at least one dose of study treatment, had an observation at 6 hours post initial dose of study medication, and had a baseline measurement.|||Hours||95% Confidence Interval|Mean
2673317|NCT01462370|Secondary|Mean Participant Global Evaluation of Pain at 24 Hours After the Initial Dose (GLOBAL24)|The GLOBAL24 was recorded by the participant at 24 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL24 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief.|24 hours|The population consisted of all participants that received at least one dose of study treatment had a GLOBAL24 observation at 24 hours post initial dose of study medication.|||Score on a Scale||Standard Error|Least Squares Mean
2673318|NCT01462370|Secondary|Mean Participant Global Evaluation of Pain at 6 Hours After the Initial Dose (GLOBAL6)|The GLOBAL6 was recorded by the participant at 6 hours (or at the time of rescue medication use) after taking the first dose of study medication. The GLOBAL6 uses a pain relief scale of 0 to 4, where 0 = poor pain relief, 1 = fair pain relief, 2 = good pain relief, 3 = very good pain relief, and 4 = excellent pain relief.|6 hours|The population consisted of all participants that received at least one dose of study treatment and had a GLOBAL6 observation at 6 hours post initial dose of study medication.|||Score on a Scale||Standard Error|Least Squares Mean
2673319|NCT01462370|Secondary|Sum of Pain Intensity Difference Scores Over the 6-Hour Time Period (SPID6)|The Pain Intensity Difference (PID) score is the difference between the baseline pain intensity (PI) score and the PI score recorded at each time point post initial dose, as calculated by subtracting the pain intensity at each of the subsequent time points from the baseline pain intensity score; therefore, it is on a -1 to 3 scale, with a large value representing a greater treatment effect. SPID6 is derived by multiplying the PID score at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours and it is on a scale of -6 to 18.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours|The population consisted of all participants that received at least one dose of study treatment, had at least one SPID6 observation up to 6 hours post initial dose of study medication, and had a baseline measurement.|||Score on a Scale||Standard Error|Least Squares Mean
2673320|NCT01462370|Primary|Total Pain Relief Score Over the First 6 Hours (TOPAR6) After the Initial Dose|TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24, with increasing scores indicating greater pain relief.|Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours|The population consisted of all participants that received at least one dose of study treatment and had at least one TOPAR6 observation up to 6 hours post initial dose of study medication.|||Score on a Scale||Standard Error|Least Squares Mean
2673321|NCT01462357|Secondary|Number of Subjects Completing the Vaccination Schedule|The number of subjects who have completed the three-dose vaccination schedule in all groups.|From Day 0 up to Month 36 (throughout the study period)|The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.|||Participants|||Count of Participants
2673751|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|26 Week follow up|||||||
2673323|NCT01462357|Secondary|Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies|Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant congenital anomaly (CA), Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing.|From Day 0 up to Month 36 (throughout the study period)|The analysis was based on the TVC, which included all subjects with the study vaccine administered and who reported any pregnancies and outcomes of reported pregnancies.|||Participants|||Count of Participants
2673324|NCT01462357|Secondary|Number of Subjects With SAEs Related to the Investigational Product, to Study Participation, to GSK Concomitant Products or Any Fatal SAE|SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related = an event assessed by the investigator as causally related to the investigational product, to study participation or to GSK concomitant products.|From Day 0 up to Month 36 (throughout the study period)|The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.|||Participants|||Count of Participants
2673325|NCT01462357|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.|From Day 0 up to Month 36 (throughout the study period)|The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.|||Participants|||Count of Participants
2673326|NCT01462357|Secondary|Number of Subjects With Medically Significant Conditions (MSCs)|MSCs were defined as AEs prompting emergency room (ER) or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs not related to common diseases. Common diseases include: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 up to Month 36 (throughout the study period)|The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.|||Participants|||Count of Participants
2673327|NCT01462357|Secondary|Number of Subjects With Potentially Immune Mediated Diseases (pIMDs)|pIMDs were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.|From Day 0 up to Month 12|The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.|||Participants|||Count of Participants
2673328|NCT01462357|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During the 30-day (from the day of vaccination up to 29 subsequent days) post-vaccination period|The analysis was based on the TVC, which included all subjects with at least one study vaccine administered.|||Participants|||Count of Participants
2673329|NCT01462357|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)] and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever above (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses|The analysis was based on the TVC, which included all subjects with at least one study vaccine administered and who had their symptom sheet completed.|||Participants|||Count of Participants
2673330|NCT01462357|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimetres (mm) of injection site.|During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses|The analysis was based on the TVC, which included all subjects with at least one study vaccine administered and who had their symptom sheet completed.|||Participants|||Count of Participants
2673331|NCT01462357|Secondary|B-cell-mediated Immune Responses in the Sub-cohort for CMI|The frequency of B-cell Elispot response to HPV-16/18 by overall status was presented. The assay was performed on a sub-cohort of approximately 100 subjects per study group.|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity, which included a sub-cohort of approximately 100 subjects per study group, who returned for blood sampling at Month 36 and for whom data concerning immunogenicity outcome measures were available at the specified time point.|||B-cells/million cells||Inter-Quartile Range|Median
2673332|NCT01462357|Secondary|T-cell-mediated Immune Responses in the Sub-cohort for Cell-Mediated Immunity (CMI)|Among immune markers expressed were Interleukin-2 (IL-2), Interferon-gamma (IFN-γ), Tumour necrosis factor-alpha (TNF-α) and CD40-ligand (CD40-L). The assay was performed on a sub-cohort of approximately 100 subjects per study group.|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity, which included a sub-cohort of approximately 100 subjects per study group, who returned for blood sampling at Month 36 and for whom data concerning immunogenicity outcome measures were available at the specified time point.|||T-cells/million cells||Inter-Quartile Range|Median
2673333|NCT01462357|Secondary|Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC|Anti-HPV 16/18 antibody titers were presented as GMT and expressed in titers using the PBNA. The assay was performed on a subset of approximately 100 subjects per study group.|At Day 0 and Months 7, 12, 18, 24 and 36|The analysis was based on the Month 36 TVC, which included a subset of approximately 100 subjects per study group, who received at least one dose of vaccine in this study, for whom data were available at the specified time points and who were seronegative before vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2673334|NCT01462357|Secondary|Anti-HPV-16/18 Seroconversion Rates as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 TVC|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers ≥40 ED50) in the serum of subjects seronegative before vaccination. The assay was performed on a subset of approximately 100 subjects per study group.|At Day 0 and Months 7, 12, 18, 24 and 36|The analysis was based on the Month 36 TVC, which included a subset of approximately 100 subjects per study group, who received at least one dose of vaccine in this study, for whom data were available at the specified time points and who were seronegative before vaccination.|||Participants|||Count of Participants
2673335|NCT01462357|Secondary|Anti-HPV-16/18 Antibody Titers as Assessed by PBNA in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity|Anti-HPV 16/18 antibody titers were presented as GMT and expressed in titers using the PBNA. The assay was performed on a subset of approximately 100 subjects per study group.|At Day 0 and Months 7, 12, 18, 24 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity, which included a subset of approximately 100 subjects per study group, who returned for blood sampling at Month 36, for whom immunogenicity data were available at the specified time point and who were seronegative before vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2673336|NCT01462357|Secondary|Anti-HPV-16/18 Seroconversion Rates as Assessed by Pseudovirion-based Neutralization Assay (PBNA) in a Subset of Subjects, Based on the Month 36 ATP Cohort for Immunogenicity|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers ≥40 ED50) in the serum of subjects seronegative before vaccination. The assay was performed on a subset of approximately 100 subjects per study group.|At Day 0 and Months 7, 12, 18, 24 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity, which included a subset of approximately 100 subjects per study group, who returned for blood sampling at Month 36, for whom immunogenicity data were available at the specified time point and who were seronegative before vaccination.|||Participants|||Count of Participants
2673337|NCT01462357|Secondary|Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 36|Data at Month 36 were also expressed as International Units per milliliter (IU/mL). Conversion factor from EU/mL to IU/mL was determined to be 1/6.1 for HPV-16 and 1/5.7 for HPV-18, using the WHO International Standards (NIBSC codes 05-134 and 10-140 for HPV-16 and HPV-18, respectively). The assay cut-offs were therefore 3.1 IU/mL and 3.2 IU/mL for anti-HPV-16 and anti-HPV-18 antibodies, respectively.|At Month 36|The analysis was based on the Month 36 ATP cohort for immunogenicity, which included subjects who returned for blood sampling at Month 36, for whom data concerning immunogenicity outcome measures were available at the specified time point and who were seronegative before vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2673338|NCT01462357|Secondary|Anti-HPV-16/18 Antibody Titers as Assessed by ELISA|Anti-HPV 16/18 antibody titers were presented as GMTs and expressed in EL.U/mL based on ELISA.|At Day 0 and Months 12, 18, 24 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity, which included subjects who returned for blood sampling at Month 36, for whom data concerning immunogenicity outcome measures were available at the specified time points and who were seronegative before vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2673339|NCT01462357|Secondary|Anti-HPV-16/18 Seroconversion Rates as Assessed by ELISA|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers ≥ 19 and 18 EL.U/mL, respectively) in the serum of subjects seronegative before vaccination.|At Day 0 and Months 12, 18, 24 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity, which included subjects who returned for blood sampling at Month 36, for whom data concerning immunogenicity outcome measures were available at the specified time points and who were seronegative before vaccination.|||Participants|||Count of Participants
2673340|NCT01462357|Primary|Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the Total Vaccinated Cohort (TVC)|Anti-HPV 16/18 antibody titers were presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.|At Month 7 (i.e. one month after the last dose of study vaccine)|The analysis was based on the TVC which included all subjects, regardless of serostatus, who received at least one dose of vaccine in this study and for whom data were available at the specified time point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2673341|NCT01462357|Primary|Anti-HPV-16/18 Antibody Titers as Assessed by ELISA at Month 7 Based on the ATP Cohort for Immunogenicity|Anti-HPV 16/18 antibody titers were presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL.|At Month 7 (i.e. one month after the last dose of study vaccine)|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the specified time point and who were seronegative before vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2673342|NCT01462357|Primary|Number of Seroconverted Subjects for Anti-HPV-16/18 Antibodies as Assessed by Enzyme-Linked Immunosorbent Assay (ELISA) at Month 7 Based on the ATP Cohort for Immunogenicity|Seroconversion was defined as the appearance of antibodies (i.e. anti-HPV-16 and anti-HPV-18 antibody titers greater than or equal to (≥) 19 and 18 ELISA units per milliliter (EL.U/mL), respectively), in the serum of subjects seronegative before vaccination.|At Month 7 (i.e. one month after the last dose of study vaccine)|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available at the specified time point and who were seronegative before vaccination.|||Participants|||Count of Participants
2673343|NCT01462344|Secondary|Percentage of Asthma Control Days Over the 6-month Study Treatment Period|An asthma control day is one on which rescue albuterol/salbutamol use was recorded as 0, no night time awakenings were recorded, no asthma exacerbations were recorded, no work, school, or daycare days were missed by caregiver or participant due to asthma, coughing symptom score was <=1 and wheezing symptom score was 0. The mean percentages of asthma control days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.|From Day 1 up to 6 months|mITT Population|||Percentage of asthma control days||Standard Error|Mean
2673344|NCT01462344|Secondary|Percentage of Rescue-free Days Over the 6-month Study Treatment Period|Rescue-free days were days without use of rescue albuterol/salbutamol (other than pre-exercise treatment) over the 6-month study treatment period. The mean percentages of rescue-free days over the months 1-6 (defined as treatment days 2-182) are summarized. Number of participants over treatment days 2-182 from mITT Population were included for this endpoint.|From Day 1 up to 6 months|mITT Population|||Percentage of rescue-free days||Standard Error|Mean
2673345|NCT01462344|Secondary|Number of Participants Withdrawn From Study Treatment Due to Asthma Exacerbation Over the 6-month Study Treatment Period|An exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days (up to 10 days) or a single depot corticosteroid injection. Number of participants experiencing at least one exacerbation from mITT population were included for this endpoint. The number of participants withdrawn from study treatment due to asthma exacerbation over the 6-month study treatment period are presented.|From Day 1 up to 6 months|mITT Population|||Participants|||Number
2673346|NCT01462344|Secondary|Number of Participants Experiencing Asthma-related Hospitalizations Over the 6-month Study Treatment Period|Hospitalization is defined as a >=24-hour stay as an inpatient or in an observation ward. The number of participants experiencing asthma-related hospitalizations over the 6-month study treatment period are presented.|From Day 1 up to 6 months|ITT Population|||Participants|||Number
2673347|NCT01462344|Secondary|Number of Participants Experiencing Asthma-related Endotracheal Intubations Over the 6-month Study Treatment Period|Intubation is defined as endotracheal intubation with ventilation (mechanical or by hand). The number of participants experiencing asthma-related endotracheal intubations over the 6-month study treatment period are presented.|From Day 1 up to 6 months|ITT Population|||Participants|||Number
2673348|NCT01462344|Secondary|Number of Participants Experiencing Asthma-related Deaths Over the 6-month Study Treatment Period.|Number of participants experiencing asthma-related death over the 6-month study treatment period are presented.|From Day 1 up to 6 months|ITT Population|||Participants|||Number
2673349|NCT01462344|Primary|Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period|Number of participants with asthma exacerbation over the 6-month study treatment period are presented. Participants from mITT population with screening childhood asthma control test (C-ACT) scores of 20 or higher, one exacerbation in the previous year, and either low-dose inhaled corticosteroid (ICS) + one or more adjunctive therapy or medium-dose ICS monotherapy or medium-dose ICS and one or more adjunctive therapy as prior asthma therapy were included for this endpoint. Time to first exacerbation analyzed using a cox proportional hazards regression model. The number of asthma exacerbations were compared between treatments using a negative binomial regression model. The modified Intent-to-Treat (mITT) Population consisted of the ITT participants with a different data cut-off for supportive analyses of the primary composite safety endpoint.|From Day 1 up to 6 months|mITT Population|||Participants|||Number
2673350|NCT01462344|Primary|Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death)|Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a >=24-hour stay in an observation area in an emergency department or other equivalent facility. Time to first event in the composite endpoint of serious asthma-related outcomes over the 6-month study treatment period was analyzed using a Cox proportional hazards regression model. An estimate of absolute risk difference and its corresponding 95% confidence interval (CI) were also included. The Intent-to-Treat (ITT) Population included all participants randomized to study drug and who took study treatment.|From Day 1 up to 6 months|ITT Population|||Participants|||Number
2673351|NCT01462318|Secondary|TP-DI Sub-study: Omeprazole/Hydroxyomeprazole Concentration Ratio at 2 Hours Post-omeprazole Dosing||Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration) at 2 hours after probe drug cocktail administration|TP-DI Sub-study population: all participants in the TP-DI substudy who had enough post-baseline measurable drug concentrations to calculate the parameter.|||ratio||Standard Deviation|Mean
2673352|NCT01462318|Secondary|TP-DI Sub-study: CL/F of Each Probe Drug|CL/F of each of the following CYP isoenzyme substrates: midazolam (CYP3A), warfarin + vitamin K (CYP2C9), and omeprazole (CYP2C19).|Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and at 0.5 and 1, 2, 3, 4, 6, 8, 10 , 24, 48, 72 and 96 hours post-probe drug cocktail administration|TP-DI Sub-study population: all participants in the TP-DI substudy who had enough post-baseline measurable drug concentrations to calculate the parameter; n=participants with an evaluable assessment at given time point.|||mL/hr||Standard Deviation|Mean
2673353|NCT01462318|Secondary|TP-DI Sub-study: Cmax of Each Probe Drug|Cmax of each of the following CYP isoenzyme substrates: midazolam (CYP3A), caffeine (CYP1A2), warfarin + vitamin K (CYP2C9), and omeprazole (CYP2C19).|Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and at 0.5 and 1, 2, 3, 4, 6, 8, 10 , 24, 48, 72 and 96 hours post-probe drug cocktail administration|TP-DI Substudy population: all participants in the TP-DI substudy who had enough post-baseline measurable drug concentrations to calculate the parameter; n=participants with an evaluable assessment at given time point.|||ng/mL||Standard Deviation|Mean
2673354|NCT01462318|Secondary|Intensive PK Sub-study: Apparent Clearance (CL/F) of DAC HYP||Day 141 (Week 20) at pre-dose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14 and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter.|||L/day||Standard Deviation|Mean
2673355|NCT01462318|Secondary|Intensive PK Sub-study: Elimination Half-life (t½) of DAC HYP||Day 141 (Week 20) at pre-dose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14 and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter.|||day||Standard Deviation|Mean
2673356|NCT01462318|Secondary|Intensive PK Sub-study: Apparent Volume of Distribution (V/F) of DAC HYP||Day 141 (Week 20) at pre-dose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14 and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter.|||Liters||Standard Deviation|Mean
2673357|NCT01462318|Secondary|Intensive PK Sub-study: Minimum Concentrations (Cmin) of DAC HYP||Day 141 (Week 20) at pre-dose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14 and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter.|||mcg/mL||Standard Deviation|Mean
2673358|NCT01462318|Secondary|Intensive PK Sub-study: Area-Under-the-Curve From Start to End of the Dosing Interval (AUCtau) of DAC HYP||Day 1 and Day 141 (Week 20) at pre-dose and 8, 24, 72, and 120 hours post-dose and 7, 10, 14, and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter; n=participants with an assessment at given time point.|||day*mcg/mL||Standard Deviation|Mean
2673359|NCT01462318|Secondary|Intensive PK Sub-study: Time to Reach Maximum Concentration (Tmax) of DAC HYP||Day 1 and Day 141 (Week 20) at pre-dose and 8, 24, 72, and 120 hours post-dose and 7, 10, 14 and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter; n=participants with an assessment at given time point.|||day||Standard Deviation|Mean
2673360|NCT01462318|Secondary|Intensive PK Sub-study: Cmax of DAC HYP||Day 1 and Day 141 (Week 20) at pre-dose and 8, 24, 72, and 120 hours post-dose and 7, 10, 14 and 21 days post-dose|PK population: all participants who participated in the Intensive PK sub-study and had enough post-study baseline measurable drug concentrations to calculate the parameter; n=participants with an assessment at given time point.|||mcg/mL||Standard Deviation|Mean
2673361|NCT01462318|Primary|TP-DI Sub-study: Dextromethorphan to Dextrorphan Urine Concentration Ratio||Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and for 12 hours after probe-drug cocktail administration|TP-DI Sub-study population: all participants in the TP-DI substudy who had enough post-baseline measurable drug concentrations to calculate the parameter; n=participants with an evaluable assessment at given time point.|||ratio||Standard Deviation|Mean
2673362|NCT01462318|Primary|TP-DI Sub-study: Area-Under-the-Curve From Zero to Infinity (AUCinf) of Each Probe Drug|AUCinf of each of the following cytochrome P450 (CYP) isoenzyme substrates: midazolam (CYP3A), S-warfarin + vitamin K (CYP2C9), and omeprazole (CYP2C19). The AUC from zero to 12 hours (AUC0-12) was calculated for caffeine (CYP1A2).|Week 43 (7 days prior to DAC HYP administration) and Week 53 (7 days after DAC HYP administration), pre-cocktail dose and at 0.5 and 1, 2, 3, 4, 6, 8, 10 , 24, 48, 72 and 96 hours post-probe drug cocktail administration|TP-DI Sub-study population: all participants in the TP-DI substudy who had enough post-baseline measurable drug concentrations to calculate the parameter; n=participants with an evaluable assessment at given time point.|||hr*ng/mL||Standard Deviation|Mean
2673363|NCT01462318|Primary|Number of Participants With Anti-DAC HYP Neutralizing Antibodies (NAbs): ECL ADA Assay|Participants with PB NAbs through Week 44, in the treatment period (extends up to 42 days after the last dose during the main study), and in the post-treatment period (43 days after the last dose until the end of the post-treatment period dose).|Up to 44 weeks|Immunogenicity evaluable population: all participants in the main study population who received at least 1 dose of DAC HYP and had at least 1 post-study baseline immunogenicity assessment; n=participants with an assessment during the given period.|||participants|||Number
2673364|NCT01462318|Primary|Number of Participants With Anti-DAC HYP Binding Antibodies (ADAbs): Electrochemiluminescent (ECL) Anti-Drug Antibody (ADA) Assay|Participants with post-baseline (PB) ADAbs through Week 44, in the treatment period (extends up to 42 days after the last dose during the main study), and in the post-treatment period (43 days after the last dose until the end of the post-treatment period dose).|Up to 44 weeks|Immunogenicity evaluable population: all participants in the main study population who received at least 1 dose of DAC HYP and had at least 1 post-study baseline immunogenicity assessment; n=participants with an assessment during the given period.|||participants|||Number
2673365|NCT01462305|Secondary|Q-LES-Q-SF|"The Q-LES-Q-SF (Quality of life enjoyment and satisfaction questionnaire short form) is a 16 question questionnaire that is enables investigators to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning.~Responses to questions range from 1 to 5, 1 being very poor and 5 being very good. Scores range from 16 to 80, the higher score the higher the participants enjoyment and satisfaction."|6 weeks|"Of the 35 participants that were randomized 28 completed the Q-LES-Q-SF at week 6.~3 subjects withdrew due to treatment-related adverse events 3 withdrew for non-study-related reasons.~Not all participants were able to complete the study related site visits or phone calls."|||units on a scale||Standard Deviation|Mean
2673366|NCT01462305|Secondary|SIGH-ADS Score (Week 1 Thru 5)|"A Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement was utilized weekly at in person visits or over the phone.~The SIGH-ADS is designed for general use in depression research and clinical evaluation, regardless of seasonality.The SIGH-ADS rates the severity of depressive symptoms in terms of Hamilton's 17-item depression score and an 8-item atypical score. Combined this provides 25 items to provide the SIGH-ADS score. SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome and the lower the score the less depressed the patient is. All participants that entered the study had to have a score of 20 or greater."|weekly, from Week 1 through week 5|"Of the 35 participants that were randomized 29 completed the study the SIGH-ADS at week 6.~3 subjects withdrew due to treatment-related adverse events 3 withdrew for non-study-related reasons. Not all participants were able to complete the study related site visits or phone calls."|||units on a scale||Standard Deviation|Mean
2673367|NCT01462305|Primary|SIGH-ADS Score|"A Structured Interview Guide for the Hamilton Depression Scale with Atypical Depression Supplement was utilized at baseline and after 6 weeks of treatment.~The SIGH-ADS is designed for general use in depression research and clinical evaluation, regardless of seasonality.The SIGH-ADS rates the severity of depressive symptoms in terms of Hamilton's 17-item depression score and an 8-item atypical score. Combined this provides 25 items to provide the SIGH-ADS score. SIGH-ADS scores range from 0-79; higher values represent increased depression severity and worse outcome, the lower the score the less depressed the patient is. All participants that entered the study had to have a score of 20 or greater."|6 weeks|"Of the 35 participants that were randomized 29 completed the study the SIGH-ADS at week 6.~3 subjects withdrew due to treatment-related adverse events 3 withdrew for non-study-related reasons."|||units on a scale||Standard Deviation|Mean
2673368|NCT01462292|Secondary|Assessment of Functional Outcome by : Physician Assessment of Daily Living|This was conducted by the physician, which helped to assess and document observed changes in the participant by the physician reported by the participant or his family or caregiver. This was reported as any worsening and any improvement up to week 24.|Week 24 and Week 48|ITT population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2673369|NCT01462292|Secondary|Assessment of Functional Outcome by : Functional Outcomes Survey During Treatment Period|This was conducted by the family or caregiver. This helped to document the observed changes in the participant's functional outcome like the day to day activities; general health, mobility, and other general daily activities. The data for Week 24 has been reported as improved, not improved and not applicable.|Up to Week 24|ITT population. Only those participants available at that particular time points were analyzed.|||Participants|||Count of Participants
2673370|NCT01462292|Secondary|Number of Clinician Global Impression of Improvement (CGI-I) Responders|Single item question designed to provide a brief, stand-alone assessment of the clinician's view of the participant's global functioning after initiating a study medication, compared to their global functioning just prior to initiating treatment. Evaluated by an expert physician or evaluator familiar with DMD and who could make an expert clinical global judgement about severity of illness across various time points within context of clinical experience. The CGI-I reflects the clinician's judgment about the total picture of the participant : the illness severity, the level of distress and other aspects of impairment, and impact of illness on functioning. The CGI-I is rated without regard to clinician's belief that any clinical changes are or are not due to medication and without consideration of etiology of symptoms. It is measured on 7-point Likert scale (1 = 'very much improved', 2 = 'much improved', 4 = 'no change', 5 = 'minimally worse', 6 = 'much worse', 7 = 'very much worse').|Week 24 and Week 48|ITT population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2673371|NCT01462292|Secondary|Number of Participants With Change From Baseline in Dystrophin Expression at Week 24 by Immunofluorescence Assay (IFA)|A muscle biopsy from the tibialis anterior muscle was taken to assess the expression of dystrophin. The muscle biopsy samples were collected by open biopsy or with the conchotome method according to standard hospital procedures for obtaining muscle biopsies from children. The minimum amount of muscle tissue required is a small piece of muscle of at least 0.5 x 0.5 x 0.5 centimeters. The muscle tissue was immediately frozen in liquid nitrogen-cooled 2-methylbutane and stored at -80°Celsius (C) or -70°C till shipment. In case of DMD participants , there is defect in the dystrophin producing gene or absence. Data for number of participants with change from baseline in dystrophin expression, was diagnosed using IFA and was categorized as strong increase, increase, and no change, decrease.|Baseline (Week 0) and Week 24|ITT population. Only those participants available at the specified timepoints were analyzed.|||Participants|||Count of Participants
2673372|NCT01462292|Secondary|Change From Baseline in Sniff Pressure Test at Week 24|This was one of the pulmonary function test which was a non-invasive procedure. It measured the inspiratory muscle strength by transdiaphragmatic (Pdi) and esophageal pressures (Pes) generated during volitional and nonvolitional maneuvers. Change from Baseline, was defined as the post-randomization value minus the baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT Population. Only those participants available at the specified time points were analyzed|||Centimeter of water||Standard Deviation|Mean
2673373|NCT01462292|Secondary|Change From Baseline in Peak Expiratory Flow at Week 24|The peak expiratory flow is a measure of the amount of air that can be pushed through the airways in a single rapid exhalation. The peak expiratory flow was measured using spirometry. Change from Baseline, was defined as the post-randomization value minus the baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT population. Only those participants available at the specified time points were analyzed|||Litres per minute||Standard Deviation|Mean
2673374|NCT01462292|Secondary|Change From Baseline in Peak Cough Flow at Week 24|The peak cough flow was conducted using a spirometer. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT population. Only those participants available at the indicated timepoints were used for analysis|||Litres per minute||Standard Deviation|Mean
2673375|NCT01462292|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Week 24|FVC is defined as the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Change from Baseline, was defined as the post-randomization value minus the baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT population. Only those participants available at the indicated timepoints were used for analysis.|||Litres||Standard Deviation|Mean
2673376|NCT01462292|Secondary|Change From Baseline in Forced Expiratory Volume in the First Second of Exhalation (FEV1) at Week 24|FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT Population. Only those participants available at the indicated timepoints were used for analysis|||Litres||Standard Deviation|Mean
2673377|NCT01462292|Secondary|Change From Baseline in Creatinine Kinase Serum Concentrations|Creatine kinase (CK) is a muscle-specific enzyme; its level in plasma is considered to reflect the extent of muscle damage. In the blood samples drawn to this purpose, the plasma level of CK was measured. Change from Baseline, was defined as the post-randomization value minus the baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 48|ITT population. Only those participants available at the specified time points were analyzed.|||International units per liter||Standard Error|Least Squares Mean
2673378|NCT01462292|Secondary|Number of Participants With Accidental Falls During 6 Minute Walk Distance Test|The participants during the 6 minute walk distance were asked to walk, at their own preferred speed, up and down a fixed distance until they were told to stop after 6 minutes. The participants were warned of the time and were told to stop earlier if they feel unable to continue. The total distance walked within the duration of 6 minutes (or until the participant stopped in case of early termination of the test), was recorded in metersThe number of accident falls during the 6 minute walk distance were reported. Data is reported for the number of participants with accidental falls of 0, 1 and 2.|Baseline (Week 0), Week 24, Week 36 and Week 48|ITT Population. Only those participants available at the specified timepoints were analyzed|||Participants|||Number
2673389|NCT01462266|Secondary|Percent of Participants Achieving Fasting Glucose Target at Any Time During the Study|The fasting glucose target was defined as 3 consecutive days with a fingerstick glucose of 72 to 100 mg/dL (4.0 - 5.6 mmol/L).|Up to 24 weeks|FAS population included all randomized participants who took at least one dose of study medication, and had at least one post-randomization glycemic goal assessment.|||Percentage of participants||95% Confidence Interval|Number
2673379|NCT01462292|Secondary|Change From Baseline in the North Star Ambulatory Assessment (NSAA) Total Score|The NSAA was a functional scale devised from Hammersmith Scale of Motor Ability specifically for use in ambulant children with DMD. It consists of 17 activities graded 0 (unable to perform), 1 (performs with modifications), 2 (normal movement). The scale assessed activities that required for ambulatory activity and included items that were rarely achieved in untreated DMD (jump, hop, raise head) as well as items that are known to progressively deteriorate over time (stand from a chair, walk). A standardized manual is available within the SPM with specific instructions for grading. Video snaps used in training program to ensure evaluator reliability. The total score ranged from 0-34 where the highest score of 34 implies absence of symptoms and lower score implies more severe symptoms. Change from Baseline, was defined as the post-randomization value minus the baseline value. Baseline was defined as Week 0.|Baselie (Week 0) and Week 24|ITT Population|||Scores on scale||Standard Error|Least Squares Mean
2673380|NCT01462292|Secondary|Change From Baseline in Muscle Strength Tests For-Knee Extensor, Knee Flexor, Hip Flexor, Elbow Flexor, Elbow Extensor, Shoulder Abductor at Week 24|The muscle strength was recorded by handheld myometry using a microFET2 myometer. Upper and lower limb proximal muscles were evaluated including knee flexors, knee extensors, elbow flexors, elbow extensors, shoulder abductors and hip flexors. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT population.|||lbs||Standard Deviation|Mean
2673381|NCT01462292|Secondary|Change From Baseline in Muscle Strength Total Score at Week 24|The muscle strength was recorded by handheld myometry using a microFET2 myometer. Upper and lower limb proximal muscles were evaluated including knee flexors, knee extensors, elbow flexors, elbow extensors, shoulder abductors and hip flexors. Total score was calculated by summing up all individual scores. If data for any of the individual muscle strength tests was missing, the total score were set to missing for that visit. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT Population. Only those participants available at the specified timepoints were analyzed|||Pounds (lbs)||Standard Error|Least Squares Mean
2673382|NCT01462292|Secondary|Change From Baseline in 10 Meter Walk/Run at Week 24|The participants during this assessment were asked to traverse marked 10-meter measured walkway as quickly as he safely can. Time was recorded to one tenth of a second with a stop watch from when his first foot crossed the start line until when the second foot crossed the finish line. How often the participant , touched the wall was to be noted. Care was taken to ensure that the participants were safe when completing this test. The assessor was allowed to walk nearby to provide 'emergency' help if needed, but must not support or provide manual assistance for the participant in any way. If the participant was unable to complete the 10-meter walk, the total distance was recorded. The participants were to perform the test in bare feet. No aids or orthoses were allowed. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT population.|||Seconds||Standard Error|Least Squares Mean
2673383|NCT01462292|Secondary|Change From Baseline in 4 Stair Climb Ascent/Descent Time at Week 24|During this assessment, the participants were asked to ascend and descend four steps. The time for this was recorded with a stopwatch from the initiation of movement until the participant stands on the fourth step, (going up and going down separately). A flight of steps with handrail were used for this test. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT Population|||seconds||Standard Error|Least Squares Mean
2673384|NCT01462292|Secondary|Change From Baseline in Rise From Floor Time at Week 24|The rise from floor was assessed, when the participants stood from a standardized supine position as quickly as possible when told to go. Time was recorded with a stopwatch from the initiation of movement until the assumption of upright standing. No aids or orthoses were allowed. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|ITT Population|||Seconds||Standard Error|Least Squares Mean
2673385|NCT01462292|Primary|Mean Change From Baseline in Muscle Function Using the 6 Minute Walking Distance|The participants during this assessment were asked to walk, at their own preferred speed, up and down a fixed distance until they were told to stop after 6 minutes. The participants were warned of the time and were told to stop earlier if they feel unable to continue. The total distance walked within the duration of 6 minutes (or until the participant stopped in case of early termination of the test), was recorded in meters. Change from Baseline, was defined as the post-randomization value minus the Baseline value. Baseline was defined as Week 0.|Baseline (Week 0) and Week 24|Intent to Treat (ITT) Population was defined as all participants who were randomized to the study, received at least one dose of study medication and have at least one post-Baseline efficacy assessment|||Meters||Standard Error|Least Squares Mean
2673386|NCT01462279|Secondary|Improvement in Hemodynamics|Hemodynamics were collected in all patients but we did not evaluate change in hemodynamics over the 9 hour protocol of the study. Due to the single-arm nature and small size of the study, and with no comparison arm, we did not think we had the statistical power to evaluate for a change in hemodynamics so this was not a planned outcome and was entered in error.|Baseline to Nine Hours|Due to the single-arm nature and small size of the study, and with no comparison arm, we did not think we had the statistical power to evaluate for a change in hemodynamics so this was not a planned outcome and was entered in error.||||||
2673387|NCT01462279|Primary|Improvement in VO2|VO2 measurements are taken at baseline and VO2 is continuously monitored over 9 hours. Thiamine is administered three hours after baseline measurements are taken.|Baseline to 9 Hours||||ml/min||Standard Deviation|Mean
2673388|NCT01462266|Secondary|Time to Achieve the Fasting Glucose Target|Fasting glucose target 3 consecutive days with a fingerstick glucose of 72 to 100 mg/dL (4.0 - 5.6 mmol/L). This analysis was the Kaplan-Meier estimated 50th percentile of time (days) to first attainment of target.|Up to 24 weeks|FAS population included all randomized participants who took at least one dose of study medication and had at least one post-randomization glycemic goal assessment.|||Days to first attainment of target||95% Confidence Interval|Median
2673390|NCT01462266|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change in FPG (before breakfast) following 24 weeks of therapy (i.e., FPG at Week 24 minus FPG at baseline)|Baseline and Week 24|FAS population included all randomized participants who took at least one dose of study medication and had at least one measurement either at baseline or post-randomization.|||mg/dL||95% Confidence Interval|Least Squares Mean
2673391|NCT01462266|Secondary|Change From Baseline in Hemoglobin A1c (A1C) at Week 24|A1C is measured as the percentage of glycosylated hemoglobin. Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline)|Baseline and Week 24|FAS population included all randomized participants who took at least one dose of study medication and had at least one measurement either at baseline or post-randomization.|||Percent of total hemoglobin||95% Confidence Interval|Least Squares Mean
2673392|NCT01462266|Primary|Change From Baseline in Daily Insulin Dose at Week 24|Change in daily insulin dose following 24 weeks of therapy (i.e., daily insulin dose at Week 24 minus daily insulin dose at baseline)|Baseline and Week 24|Full Analysis Set (FAS) population included all randomized participants who took at least one dose of study medication and had at least one measurement either at baseline or post-randomization.|||International Units (IU)||95% Confidence Interval|Least Squares Mean
2673393|NCT01462253|Secondary|Cumulative Incidence of Relapse (CIR)|Cumulative incidence of relapse (CIR) at 1 year, it will be calculated from the date of achievement of the first CR, using the cumulative incidence method, considering death in CR as a competing risk. Patients still alive, without a date of relapse, will be censored at the time of the last follow-up. In this case, the CIR curve will be truncated at 1 year.|At one year from therapy completion.|"Cumulative incidence of relapse was estimated only in CR patients (n=16) from date of first CR to date of death, relapse or last follow-up; considering death in CR as a competing risk.~Median CIR not yet reached."|||Percentage of patients||95% Confidence Interval|Number
2673394|NCT01462253|Secondary|Overall Survival (OS)|Overall Survival (OS) at 1 year; defined as the time interval between inclusion and death for any cause; patients still alive will be censored at the time of the last follow-up. In this case, the OS curve will be truncated at 1 year.|At one year from therapy completion.|Overall survival was estimated from date of informed consent to date of death or last follow-up.|||Percentage of patients||95% Confidence Interval|Number
2673395|NCT01462253|Secondary|Disease-free Survival (DFS)|Disease-free survival (DFS) at 1 year, defined as the time interval between the evaluation of CR and relapse of the disease or death in first CR; patients still alive, in first CR, will be censored at the time of the last follow-up. In this case, the DFS curve will be truncated at 1 year|At one year from completion of chemotherapy|Disease-free survival was estimated in CR patients (n=16) from date of first CR to date of death, relapse or last follow-up.|||Percentage of patients||95% Confidence Interval|Number
2673396|NCT01462253|Secondary|Number of Participants With Minimal Residual Disease (MRD) Response in Remission.||At week 10, 16 and 22 from start of treatment and the, every three months till study completion||||Participants|||Count of Participants
2673397|NCT01462253|Secondary|Number of Participants With Toxicity of Grade 2 or Greater|Referring to CTCAE (Common Toxicity Criteria Events), version 4.0|At 13 months from study entry||||Participants|||Count of Participants
2673398|NCT01462253|Primary|The Primary End-point is the Number of Patients in CR After Induction Therapy.|Disappearance of any clinical and laboratoristic sign of ALL. The patient must be transfusion-free with neutrophils >1.0 x109/L and platelets >100 x109/L. BM examination must show absence or reduction of blast cell content (< 5%, none of which obviously leukemic), with cellularity in the normal or slightly hypocellular range and with evidence of trilineage hemopoiesis. BM is examined on day 28 from start of chemotherapy cycle 1, or later as clinically indicated in ill/cytopenic patients, and after cycle 2 in patients with PR proceeding to this treatment.|At day +28 from start of chemotherapy cycle 1 and after cycle 2 in pts with PR||||Participants|||Count of Participants
2673399|NCT01462227|Secondary|Norepinephrine (pg/mL)|Norepinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.|||pg/mL||Standard Deviation|Mean
2673400|NCT01462227|Secondary|Epinephrine (pg/mL)|Epinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.|||pg/mL||Standard Deviation|Mean
2673401|NCT01462227|Secondary|Cortisol (ug/dL)|Cortisol was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.|||ug/dL||Standard Deviation|Mean
2673402|NCT01462227|Secondary|Glucagon (pg/mL)|Glucagon was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.|||pg/mL||Standard Deviation|Mean
2673403|NCT01462227|Primary|Glucose Infusion Rate (mg/kg.Min)|The glucose infusion rate corresponds to the amount of 20% dextrose given during the hyperinsulinemic-hypoglycemic clamp study, necessary to keep blood glucose levels at the target range (50-55 mg/dL).|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.|||mg/kg.min||Standard Deviation|Mean
2673404|NCT01462227|Primary|Glucose (mg/dL)|Glucose was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.|End of study (up to 240 minutes)|Subjects' data were pooled and only those that completed both visits are analyzed here.|||mg/dL||Standard Deviation|Mean
2673405|NCT01462162|Secondary|Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 - Safety Population|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score <=3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.' Participants with response is reported. DAS28 is described in outcome measure 19.|Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.|||percentage of participants|||Number
2673423|NCT01462162|Secondary|Change From Baseline to Week 12 and 24 in Serum Hemoglobin|The hemoglobin level was measured in grams per liter (g/L). Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants for each category.|||g/L||Standard Deviation|Mean
2673406|NCT01462162|Secondary|Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score <=3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.' Participants with response is reported. DAS28 is described in outcome measure 19.|Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.|||percentage of participants|||Number
2673407|NCT01462162|Secondary|Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 - Safety Population|DAS28-4 ESR was calculated from SJC and TJC using 28 joints count, ESR mm/hr and PtGA of disease activity (participant rated arthritis activity assessment). The DAS28-ESR score (14) was calculated using the following formula: DAS28 = 0.56 x (square root TJC) + 0.28 x (square root SJC) + 0.70 x [Ln(ESR)] + 0.014 x (PtGA).Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission. PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad. Analysis include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure.|||score on a scale||Standard Deviation|Mean
2673408|NCT01462162|Secondary|Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24|DAS28-4 erythrocyte sedimentation rate (ESR) was calculated from SJC and tender joint count (TJC) using 28 joints count, ESR millimeter per hour (mm/hr) and patient global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). The DAS28-ESR score (14) was calculated using the following formula: DAS28 = 0.56 x (square root TJC) + 0.28 x (square root SJC) + 0.70 x [Ln(ESR)] + 0.014 x (PtGA).Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=) 3.2 implied low disease activity and greater than (>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) less than (<)2.6 = remission. PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis: All participants who had at least one measurement of effectiveness subsequent to the start of tocilizumab (RoActemra) treatment were included. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.|||score on a scale||Standard Deviation|Mean
2673409|NCT01462162|Secondary|Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 - Safety Population|Mood assessed by the Beck Depression Inventory. The Beck Depression Inventory is a 21-item self-administered scale that evaluates severity of depression and is validated in Spanish on a 3 point scale (0=none to 3=severe). It measures the characteristic attitudes and symptoms of depression such as mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, etc. The total score ranges from 0 to 63. A score higher than 18 indicates moderate to severe symptoms of depression. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.|||score on a scale||Standard Deviation|Mean
2673410|NCT01462162|Secondary|Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24|Mood assessed by the Beck Depression Inventory. The Beck Depression Inventory is a 21-item self-administered scale that evaluates severity of depression and is validated in Spanish on a 3 point scale (0=none to 3=severe). It measures the characteristic attitudes and symptoms of depression such as mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, etc. The total score ranges from 0 to 63. A score higher than 18 indicates moderate to severe symptoms of depression. Analysis include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure.|||score on a scale||Standard Deviation|Mean
2673411|NCT01462162|Secondary|Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 - Safety Population|Degree of sleepiness was assessed by Epworth Sleepiness Scale. The Epworth Sleepiness Scale evaluates how likely a person is to doze off or fall asleep in 8 different sedentary situations, using for each item possible scores of 0 to 3 (0=never, 1=mild, 2=moderate and 3=severe). A final score is obtained between 0-24, where a higher score indicates a higher degree of sleepiness. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.|||score on a scale||Standard Deviation|Mean
2673412|NCT01462162|Secondary|Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24|Degree of sleepiness was assessed by Epworth Sleepiness Scale. The Epworth Sleepiness Scale evaluates how likely a person is to doze off or fall asleep in 8 different sedentary situations, using for each item possible scores of 0 to 3 (0=never, 1=mild, 2=moderate and 3=severe). A final score is obtained between 0-24, where a higher score indicates a higher degree of sleepiness. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.|||score on a scale||Standard Deviation|Mean
2673413|NCT01462162|Secondary|Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 - Safety Population|Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.|||centimeter||Standard Deviation|Mean
2673414|NCT01462162|Secondary|Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24|Change from Baseline in 10 centimeter (cm) VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure.|||centimeter||Standard Deviation|Mean
2673415|NCT01462162|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 12, 24 - Safety Population|Duration of morning stiffness assessed as time taken to achieve maximum improvement from time participant rises. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.|||hours||Standard Deviation|Mean
2673416|NCT01462162|Secondary|Change From Baseline in Duration of Morning Stiffness at Week 12, 24|Duration of morning stiffness assessed as time taken to achieve maximum improvement from time participant rises. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure.|||hours||Standard Deviation|Mean
2673417|NCT01462162|Secondary|Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 - Safety Population|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, 24|Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.|||swollen joints||Standard Deviation|Mean
2673418|NCT01462162|Secondary|Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24|Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.|Baseline, Week 12, Week 24|Effectiveness analysis population. N=participants who were evaluable for this outcome measure.|||swollen joints||Standard Deviation|Mean
2673419|NCT01462162|Secondary|Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in the Number of Swollen Joints (SJC 28) at Week 12 and 24 - Safety Population|Regression analysis between the change in hemoglobin level and number of swollen joints was evaluated. Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.|Week 12, 24|Safety analysis population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.|||unstandardized regression coefficient|||Number
2673420|NCT01462162|Secondary|Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population|Regression analysis between change in hemoglobin level and change in following variable were assessed: Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.|Week 12, 24|Safety analysis population. Here, N=number of participants analyzed for this measure.|||unstandardized regression coefficient|||Number
2673421|NCT01462162|Secondary|Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24|Regression analysis between change in hemoglobin level and change in following variable were assessed: Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.|Week 12, 24|Effectiveness analysis population. N=number of participants analyzed for this measure.|||unstandardized regression coefficient|||Number
2673422|NCT01462162|Secondary|Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24|Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), serum hemoglobin, swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.|Week 12, 24|Effectiveness analysis population. Here, N=number of participants analyzed for this measure.|||unstandardized regression coefficient|||Number
2673424|NCT01462162|Secondary|Change From Baseline to Week 12 and 24 in Fatigue Score as Assessed by FACIT-F|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Baseline, Week 12, Week 24|Effectiveness analysis population.|||units on a scale||Standard Deviation|Mean
2673425|NCT01462162|Primary|Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 24 and Change in Main Variables at Week 24|Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.|Week 24|Effectiveness analysis population. Here, N=number of participants evaluable for this measure.|||unstandardized regression coefficient|||Number
2673426|NCT01462162|Primary|Regression Coefficient Between Change in Fatigue Score as Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Week 12 and Change in Main Variables at Week 12|Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.|Week 12|Effectiveness analysis population included all participants who had all measurements of effectiveness and had complete information of the FACIT questionnaire throughout the study. Here, Number of participants analyzed (N) = number of participants evaluable for this measure.|||unstandardized regression coefficient|||Number
2673427|NCT01462110|Secondary|Microbiological Assessments - LOG Counts|"An assay (a checkerboard DNA-DNA hybridization) was conducted to estimate the number of bacterial cells in collected plaque samples. First, the bacterial cells were lysed (split open) in solution. DNA from the bacteria was then detected using fluorescent probes for different bacterial species. The sensitivity of the assay was 10^4 cells and failure to detect a signal was recorded as zero. Signals were converted to log counts by comparison with the fluorescent signal of standards of known concentrations.~The following hybridized categories of bacteria were analyzed:~Actinomyces species~Purple complex~Yellow complex~Green complex~Orange complex~Red complex~Other species"|4 weeks|Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.|||LOG counts of bacterial cells||Standard Deviation|Mean
2673428|NCT01462110|Secondary|Microbiological Assessments - Absolute Counts|"An assay (a checkerboard DNA-DNA hybridization) was conducted to estimate the number of bacterial cells in collected plaque samples. First, the bacterial cells were lysed (split open) in solution. DNA from the bacteria was then detected using fluorescent probes for different bacterial species. The sensitivity of the assay was 10^4 cells and failure to detect a signal was recorded as zero. Signals were converted to absolute counts by comparison with the fluorescent signal of standards of known concentrations.~The following hybridized categories of bacteria were analyzed:~Actinomyces species~Purple complex~Yellow complex~Green complex~Orange complex~Red complex~Other species"|4 weeks|Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.|||10^5 bacterial cells||Standard Deviation|Mean
2673429|NCT01462110|Secondary|Whole-mouth Mean Bleeding Index (BI)|Bleeding after periodontal probe was assessed by scores on a scale of 0-2 using the Gingival Bleeding Index (BI), where 0=Absence of Bleeding after 30 Seconds and 2=Immediate Bleeding.|4 Weeks|Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.|||Units on a scale||Standard Deviation|Mean
2673430|NCT01462110|Secondary|Whole-mouth Mean Bleeding Index (BI)|Bleeding after periodontal probe was assessed by scores on a scale of 0-2 using the Gingival Bleeding Index (BI), where 0=Absence of Bleeding after 30 Seconds and 2=Immediate Bleeding.|2 Weeks|Intent to treat population was analyzed.|||Units on a scale||Standard Deviation|Mean
2673431|NCT01462110|Secondary|Whole-mouth Mean Plaque Index (PI)|Plaque was assessed on a scale of 0-5 using the Turesky modification of the Quigley-Hein Plaque Index, where 0=No plaque and 5=Plaque covering 2/3 or more of surface.|2 Weeks|The intent-to-treat population was used for analysis.|||Units on a scale||Standard Deviation|Mean
2673432|NCT01462110|Secondary|Whole-mouth Mean Modified Gingival Index (MGI)|Gingivitis was assessed by scoring inflammation on a 0-4 scale, according to the Modified Gingival Index, where 0=Normal and 4=Severe Inflammation.|2 weeks|Intent to treat population was used for analysis.|||Units on a scale||Standard Deviation|Mean
2673433|NCT01462110|Primary|Whole-mouth Mean Plaque Index (PI)|Plaque was assessed on a scale of 0-5 using the Turesky modification of the Quigley-Hein Plaque Index, where 0=No plaque and 5=Plaque covering 2/3 or more of surface.|4 weeks|Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.|||Units on a scale||Standard Deviation|Mean
2673434|NCT01462110|Primary|Whole-mouth Mean Modified Gingival Index (MGI)|Gingivitis was assessed by scoring inflammation on a 0-4 scale, according to the Modified Gingival Index (MGI) where 0=Normal and 4=Severe Inflammation.|4 weeks|Intent to treat population was analyzed; one subject discontinued from the study prior to Week 4.|||Units on a scale||Standard Deviation|Mean
2673435|NCT01462084|Secondary|Patient Comfort|Subjects completed patient-satisfaction questionnaires after each polysomnography (PSG) study. Satisfaction with PAP: 0=Very Dissatisfied, 100=Very Satisfied|Up to 1 month||||units on a scale||Standard Deviation|Mean
2673752|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|12 Week follow up|||||||
2673436|NCT01462084|Primary|Apnea Hypopnea Index (AHI)|Subjects completed 2 overnight sleep studies (polysomnography (PSG)). The Apnea Hypopnea Index (AHI) metric is collected from the PSG study. Patients were equally distributed according to the therapy used first (ASV then Bi-Level or Bi-Level then ASV).|Up to 1 month||||events/hour||Standard Deviation|Mean
2673437|NCT01462045|Secondary|Cortisol|Change from baseline in serum cortisol levels at 8 weeks. Serum cortisol samples were collected at 8:00 Ante Meridian (AM). The changes are calculated from two time points as the values at 8 weeks minus the values at baseline.|baseline and 8 weeks||||μg/dl||Standard Deviation|Mean
2673438|NCT01462045|Primary|Change From Baseline in PTSD Checklist - Civilian Version (PCL-C) Score|The PCL-C is a 17-item self-report instrument that measures the symptoms of PTSD. A total score, ranging from 17 to 85, is found by summing the scores of the 17 items. Higher values are considered to be a worse outcome. The inclusion criteria in the PTSD symptomatic group is a PCL-C total score of at least 28 with a score of 3 or higher on 1 or more items.To detect a reduction in PTSD symptom severity with a 2-sided 5% significance level and a power of 80%, the mean difference of PCL-C scores of 5.16 or greater requires a sample size of 20 participants for Exercise and Control groups, given an anticipated dropout rate of 10%. Data analyses are conducted using an a priori intention-to-treat approach. The analysis for the between-group differences of the intervention is conducted using t-tests comparing Exercise and Control groups at post-intervention. The analysis for the within-group difference is conducted using repeated measures ANOVA for both groups at baseline and week 8.|Baseline and 8 weeks|For Base Group, the values entered represent the mean value of the baseline PCL-C scores. The mean difference score for the Base Group is not available because the Base Group was assessed only at baseline.|||scores on a scale||Standard Deviation|Mean
2673439|NCT01461993|Primary|Percentage of Participants With at Least One Adverse Event (AE)||Vaccination 1 up to 1 month after Vaccination 3||||percentage of participants|||Number
2673440|NCT01461993|Secondary|Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titer (GMT)||Before Vaccination 1, 1 month after Vaccination 2, 3||||titer||95% Confidence Interval|Geometric Mean
2673441|NCT01461993|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level||Before Vaccination 1, 1 month after Vaccination 2, 3||||percentage of participants|||Number
2673442|NCT01461993|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)||Before vaccination 1, 1 month after vaccination (Vac) 2, 3||||percentage of participants|||Number
2673443|NCT01461993|Secondary|Percentage of Baseline Seropositive Participants: Group 1 and 3 Participants||Before vaccination 1||||percentage of participants|||Number
2673444|NCT01461993|Secondary|Percentage of Participants Achieving Seroconversion for Human Papillomavirus (HPV)||1 month after Vaccination 3||||percentage of participants|||Number
2673445|NCT01461993|Primary|Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24]||1 month after Vaccination 3||||titer||95% Confidence Interval|Geometric Mean
2673446|NCT01461993|Primary|Geometric Mean Titer (GMT) of Human Papillomavirus (HPV) Antigens||1 month after Vaccination 3||||titer||95% Confidence Interval|Geometric Mean
2673447|NCT01461980|Other Pre-specified|Percentage of Participants With at Least One Adverse Event (AE)|An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.|Vaccination phase (baseline up to 1 month after Vaccination 3); Follow-up phase (from 1 month up to 6 months after Vaccination 3)|Safety population included all participants who received at least 1 dose of the investigational product and had safety information available. 'N' signifies participants evaluable for this measure during specified time period.|||percentage of participants|||Number
2673448|NCT01461980|Other Pre-specified|Percentage of Participants Achieving at Least 4-Fold Increase in Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level||1 Month after Vaccination (Vac) 2, 3|Post vaccination 3 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point and baseline.|||percentage of participants||95% Confidence Interval|Number
2673449|NCT01461980|Other Pre-specified|Immunogloblulin G (IgG) Measured by GMC|IgG GMCs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) of participants were computed along with corresponding 2-sided 95% CIs. CIs were back transformations of confidence levels based on Student t distribution for mean logarithm of titers.|Before Vaccination 1, 1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population.|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
2673450|NCT01461980|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Prespecified Titer Level|Antibody hSBA of primary strain PMB80 [A22] and PMB2948 [B24] with hSBA titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 were computed along with corresponding 2-sided 95% CIs.|Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3|Post vaccination 3 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.|||percentage of participants||95% Confidence Interval|Number
2673451|NCT01461980|Secondary|Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >= Lower Limit of Quantitation (LLOQ)|Percentage of participants achieving hSBA titer >= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 [A22] and 1:8 for PMB2948 [B24].|Before Vaccination 1, 1 Month after Vaccination (Vac) 2, 3|Post vaccination 3 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.|||percentage of participants||95% Confidence Interval|Number
2673472|NCT01461824|Primary|Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks|Lumbar spine bone mineral density measured at baseline and 48 weeks. Percent change over this time was calculated.|Percent change from baseline to 48 Weeks||||percent change||Standard Deviation|Mean
2673753|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|5 weeks (or after treatment session 10)|||||||
2673452|NCT01461980|Secondary|Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] Before Vaccination 1 and 1 Month After Vaccination 2|Antibody hSBA of primary strain PMB80 [A22] and PMB2948 [B24] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis.|Before Vaccination 1, 1 Month after Vaccination (Vac) 2|Post vaccination 3 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.|||titer||95% Confidence Interval|Geometric Mean
2673453|NCT01461980|Secondary|Percentage of Participants Achieving Predefined Antibody Level for Diphtheria and Tetanus Antigens|Participants with antibody concentration level of greater than or equal to 1.0 IU/mL for diphtheria and tetanus antigens were computed along with corresponding 2-sided 95% CIs.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies participants with valid, determinate assay results for given antigen.|||percentage of participants||95% Confidence Interval|Number
2673454|NCT01461980|Secondary|Percentage of Participants With Seroresponse for Tetanus, Diphtheria and Acellular Pertussis (Tdap) and Meningococcal Conjugate Vaccine (MCV4) Antigens|Seroconversion rate for Tdap antigens was defined as greater than or equal to (>=) 4-, 2-fold rise in antibody concentration, if prevaccination antibody concentration was less than or equal to (<=), greater than (>) cutoff value, respectively. For MCV4 antigens >=4-fold rise on serum bactericidal assay using rabbit complement (rSBA) titers if baseline value >= lower limit of quantitation (LLOQ), postdose rSBA titers >=2×LLOQ if baseline value was less than (<) LLOQ. Cutoff value =0.1 IU/mL for diphtheria and tetanus, 0.9,2.9,3.0,10.6 EU/mL for pertussis toxoid, filamentous hemagglutinin, pertactin, fimbriae agglutinogens types 2 + 3, respectively.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies participants with valid, determinate assay results for given antigen at specified time point and baseline. 'N' signifies number of participants with seroresponse.|||percentage of participants||95% Confidence Interval|Number
2673455|NCT01461980|Primary|Serum Bactericidal Assay Using Human Complement (hSBA) GMTs of PMB80 [A22] and PMB2948 [B24] 1 Month After Vaccination 3|Antibody hSBA GMTs of primary strain PMB80 [A22] and PMB2948 [B24] were computed along with corresponding 2-sided 95% CIs. hSBA titers from the 2 primary strains were logarithmically transformed for analysis. Here, 'number of participants analyzed' signifies evaluable immunogenicity population and 'N' signifies participants with valid and determinate assay results for given strain for each group, respectively.|1 Month after Vaccination 3|Post vaccination 3 evaluable immunogenicity population: eligible participants randomized to Group 1 or 3, received scheduled investigational product, had pre and post vaccination blood drawn at pre-specified time points, had valid, determinate assay results for proposed analysis, received no prohibited vaccines, no other major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
2673456|NCT01461980|Primary|Geometric Mean Titer (GMT) for Meningococcal Conjugate Vaccine (MCV4) Antigens|Antibody GMTs of 4 MCV4 antigens (serogroup A, serogroup C, serogroup Y and serogroup W-135) were computed along with corresponding 2-sided 95% CIs.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population. Here, ‘N’ signifies participants with valid and determinate assay results for given strain for each group, respectively.|||titer||95% Confidence Interval|Geometric Mean
2673457|NCT01461980|Primary|Geometric Mean Concentrations (GMC) for Acellular Pertussis Antigens|Antibody GMCs of 4 acellular pertussis antigens (pertussis toxoid, pertussis filamentous hemagglutinin, pertussis pertactin and pertussis fimbrial agglutinogens types 2+3) were computed in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL) along with corresponding 2-sided 95% CIs.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population. Here, ‘number of participants analyzed’ signifies participants with valid and determinate assay results for given antigen.|||EU/mL||95% Confidence Interval|Geometric Mean
2673458|NCT01461980|Primary|Geometric Mean Concentrations (GMC) for Diphtheria and Tetanus Antigens|Antibody GMCs of 2 antigens of diphtheria and tetanus toxoid were computed in International Units per milliliter (IU/mL) along with corresponding 2-sided 95 percent (%) confidence intervals (CIs). Here, 'number of participants analyzed' signifies participants with valid and determinate assay results for given antigen.|1 Month after Vaccination 1|Post vaccination 1 evaluable immunogenicity population: eligible participants randomized to Group 1 or 2, received scheduled investigational product, had pre and post vaccination blood drawn at pre-specified time points, had valid, determinate assay results for proposed analysis, received no prohibited vaccines, no other major protocol violations.|||IU/mL||95% Confidence Interval|Geometric Mean
2673459|NCT01461928|Secondary|Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia|Progression free survival from first induction treatment (PFSregist) is defined as the time from date of first rituximab induction dose to the date of first documented disease progression or death by any cause, whichever occurs first.|From day of first rituximab induction dose up to disease progression or death, whichever occurs first (up to approximately 87 months)|The ITT population included all participants who had completed a Baseline visit and at least one on-treatment assessment and were enrolled into each period of the study; Induction, Maintenance I and Maintenance II.|||Months||95% Confidence Interval|Median
2673460|NCT01461928|Secondary|Maintenance I: Percentage of Participants With Conversion of PR to CR Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia||From day of first rituximab induction dose up to end of Maintenance I period (up to approximately 32 months)|The Maintenance I participant analysis group consisted of a subgroup of responding participants who completed Induction and successfully enrolled into Maintenance I. Participants who had partial response (PR) at the end of Induction were included in this analysis.|||Percentage||95% Confidence Interval|Number
2673473|NCT01461811|Secondary|Back Surface Debris/Deposits (None, Very Slight)|"Back surface debris/deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface debris/deposits were graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Percentage of lenses|||Number
2673461|NCT01461928|Secondary|Percentage of Participants With Partial or Complete Tumor Response (PR/CR) Assessment at End of Induction Using 1999 International Working Group Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia|Overall response rate is defined as the proportion of responders at the end of the Induction period. A responder is defined as a participant experiencing either CR or PR tumor response according to the Cheson response criteria for indolent lymphoma or the recommendations for Waldenström's macroglobulinemia.|From day of first rituximab induction dose up to end of induction period (up to approximately 8 months)|The ITT population included all participants who had completed a Baseline visit and at least one on-treatment assessment and were enrolled into each period of the study; Induction, Maintenance I and Maintenance II.|||Percentage of Participants||95% Confidence Interval|Number
2673462|NCT01461928|Secondary|Maintenance II: Overall Survival|Overall survival from randomization (OSrand) is defined as the time from date of randomization to the date of death, irrespective of cause.|From randomization (Maintenance II) up to death (up to approximately 24 months)|The analysis population was the randomised ITT population (ITTrand), which included only randomised participants (Maintenance II only) and was used for the analysis of the primary efficacy endpoint of PFS and the secondary analysis endpoint overall survival (OS).|||Months||95% Confidence Interval|Median
2673463|NCT01461928|Secondary|Overall Survival|Overall survival from first induction treatment (OSRegist) is defined as the time from date of first rituximab induction dose to the date of death, irrespective of cause. One participant died in Induction before randomization and one participant died in Maintenance II Observation arm due to an SAE and were not considered in the analysis as no death page was completed.|From day of first rituximab induction dose up to death (up to approximately 87 months)|The ITT population included all participants who had completed a Baseline visit and at least one on-treatment assessment and were enrolled into each period of the study; Induction, Maintenance I and Maintenance II.|||Months||95% Confidence Interval|Median
2673464|NCT01461928|Secondary|Time to Next Lymphoma Treatment (TNLT)|Time to next lymphoma treatment (TNLT) is defined as the time from date of first rituximab induction dose to the date date of first documented intake of any new antilymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc.).|From day of first rituximab induction dose up to any new lymphoma treatment (up to approximately 87 months)|The analysis population was the randomised ITT population (ITTrand), which included only randomised participants (Maintenance II only) as well as the ITT population, that included all participants who had completed a Baseline visit and at least one on-treatment assessment (Induction, Maintenance I and Maintenance II).|||Months||95% Confidence Interval|Median
2673465|NCT01461928|Secondary|Event-free Survival (Time to Treatment Failure) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia|Event-Free Survival was measured from the day of first rituximab Induction dose through Maintenance I and Maintenance II rituximab arm until the date of any treatment failure, including disease progression, or discontinuation of treatment for any reason (e.g. disease progression, toxicity, patient preference, initiation of new anti-lymphoma treatment, or death). Treatment discontinuation was considered as an event and was not applicable to the randomized observation arm.|From day of first rituximab induction dose up to day of any treatment failure, including disease progression, or discontinuation of treatment for any reason (up to approximately 87 months)|All participants who were enrolled into the given study period and had received at least one dose of study treatment at any time were included in the ITT population for each period of the study; Induction, Maintenance I and Maintenance I|||Months||95% Confidence Interval|Median
2673466|NCT01461928|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs, and Infusion/Administration-related Reactions (IRRs/ARRs)|An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 (obtained retrospectively) were collected for this arm. Therefore arms are not comparable overall.|From day of first rituximab induction dose up to day of disease progression, or discontinuation of treatment for any reason (up to approximately 87 months)|The safety population included all participants who received at least one dose of study drug and had a safety assessment performed post randomization.|||Participants|||Number
2673467|NCT01461928|Primary|Maintenance II: Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia|Progression free survival from randomization (PFSrand) is defined as the time from date of randomization to the date of first documented disease progression or death, whichever occurs first. One participant died in Induction before randomization and one participant died in Maintenance II Observation arm due to an SAE and were not considered in the analysis as no death page was completed. The Observation arm did not include one participant with AE outcome of death reported retrospectively 2 months after discontinuation from study (censored as having no event on Day 456 post-randomization).|From randomization (Maintenance II) up to disease progression or death, whichever occurs first (up to approximately 24 months)|The primary efficacy analysis population was the ITT population (ITTrand), which included only randomised participants (Maintenance II only) and was used for the analysis of the primary efficacy endpoint of PFS and the secondary analysis endpoint overall survival (OS). The PFS end point was not reached.|||Months||95% Confidence Interval|Median
2673468|NCT01461863|Secondary|Maternal BMI at 9 Months|Maternal BMI at 9 months|9 months||||kg/m^2||Standard Error|Median
2673469|NCT01461863|Primary|Infant Weight|Infant weight at 3 months|3 months||||kg||Standard Deviation|Mean
2673470|NCT01461824|Secondary|Percent Change in Total Hip BMD From Baseline to 48 Weeks|Total hip bone mineral density was assessed at baseline and 48 weeks. Percent change from baseline to 48 weeks was calculated.|Percent change from baseline to 48 weeks||||Percent change||Standard Deviation|Mean
2673471|NCT01461824|Primary|Proportion of Participants With >5% Weight Gain at 24 Weeks|Individual subjects will be assessed after their Week 24 visit.|Week 24||||Participants|||Count of Participants
2673474|NCT01461811|Secondary|Front Surface Deposits (None, Very Slight)|"Front surface deposits on the contact lens, as assessed by the investigator for each eye individually. Front surface deposits were graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Percentage of lenses|||Number
2673475|NCT01461811|Secondary|Front Surface Wettability (None, Very Slight)|"Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Front surface wettability was graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Percentage of lenses|||Number
2673476|NCT01461811|Secondary|Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)|"Lens fit, as assessed by the investigator for each eye individually. Lens fit was graded on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. The combined percentage of lenses assessed as optimal, acceptably loose, or acceptably tight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Percentage of lenses|||Number
2673477|NCT01461811|Secondary|Lens Centration (Centered, Slight Decentration)|"Lens centration, as assessed by the investigator for each eye individually. Lens centration was graded on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as centered or slight decentration is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Percentage of lenses|||Number
2673478|NCT01461811|Secondary|Subjective Rating of Overall Handling|Overall handling, as rated by the participant on a 10-point scale, with 1 being difficult and 10 being easy. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2673479|NCT01461811|Secondary|Subjective Rating of Overall Vision|Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2673480|NCT01461811|Secondary|Subjective Rating of End of Day Dryness|End of day dryness, as rated by the participant on a 10-point scale, with 1 being dry and 10 being not dry. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2673481|NCT01461811|Secondary|Subjective Rating of Overall Comfort|Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2673482|NCT01461811|Secondary|Subjective Rating of End of Day Comfort|End of day comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2673483|NCT01461811|Secondary|Subjective Rating of Insertion Comfort|Insertion comfort (30 seconds to 1 minute), as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Units on a scale||Standard Deviation|Mean
2673484|NCT01461811|Primary|Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)|Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.|Up to Month 3|All enrolled and dispensed participants, with exclusions due to reasons such as discontinuations and/or missing responses.|||Percentage of eyes|||Number
2673485|NCT01461733|Primary|Conversion From Atrial Fibrillation to Sinus Rhythm|Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days.|From randomization to conversion or ICU discharge up to 100 months.||||participants|||Number
2673486|NCT01461707|Secondary|7-Day Physical Activity Recall|Change in mean energy expenditure|12 weeks||||kcal/day||Standard Deviation|Mean
2673487|NCT01461707|Primary|Physical Activity Monitor Measured Steps|Change in weekly mean steps per day|12 weeks||||step||Standard Deviation|Mean
2673488|NCT01461668|Primary|Proportion of Participants With MRSA Clearance|Proportion of participants with MRSA clearance at the end of the follow up period|47 days|The total number of participants analyzed include those that completed the study (through day 47).|||Participants|||Count of Participants
2673489|NCT01461655|Secondary|Investigator Global Assessment (IGA) of Disease Severity|"The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe).~The outcome was the proportion of success (improvement of two grades of the IGA) from baseline to the end of treatment. Success is defined as improvement of two grades from the baseline assessment."|Baseline to End of treatment (4 weeks)||||participants|||Number
2673490|NCT01461655|Secondary|Percentage Change in Total Lesions Count|Percentage change in total lesions count from baseline to day 22|Baseline to Day 22||||percentage of change||Standard Deviation|Mean
2673491|NCT01461655|Secondary|Percentage Change in Total Lesions Count|Percentage change in total lesions count from baseline to day 15|Baseline to Day 15||||percentage of change||Standard Deviation|Mean
2673498|NCT01461538|Secondary|Incidence of Anti-therapeutic Antibodies (ATA)|Counts of participants with post-baseline anti-brentuximab vedotin antibodies. Persistently positive is defined as confirmed ATA in more than 2 post-baseline samples and transiently positive is defined as confirmed ATA in 1 or 2 post-baseline samples.|Up to approximately 3 years|Immunogenicity-evaluable set|||participants|||Number
2673499|NCT01461538|Secondary|Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough)||Up to approximately 3 years|All treated patients with available MMAE Ctrough results|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2673500|NCT01461538|Secondary|Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)||Up to approximately 3 years|All treated patients with available Cmax of MMAE results|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2673501|NCT01461538|Secondary|Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough)||Up to approximately 3 years|All treated patients with available ADC Ctrough results|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2673502|NCT01461538|Secondary|Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi)||Up to approximately 3 years|All treated patients with available ADC Ceoi results|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2673503|NCT01461538|Secondary|Laboratory Abnormalities >/= Grade 3|Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 4.03. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category|Up to approximately 3 years|All treated patients|||participants|||Number
2673504|NCT01461538|Secondary|Adverse Events by Severity, Seriousness, and Relationship to Treatment|Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-013). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|Up to approximately 3 years|All treated patients|||participants|||Number
2673505|NCT01461538|Secondary|Progression-Free Survival by Kaplan-Meier Analysis|Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause|Up to approximately 2 years|All treated patients, excluding 3 patients without available response results|||months||95% Confidence Interval|Median
2673506|NCT01461538|Secondary|Duration of Complete Response by Kaplan-Meier Analysis|Duration of CR, defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).|Up to approximately 2 years|Participants with CR|||months||Full Range|Median
2673507|NCT01461538|Secondary|Duration of Objective Response by Kaplan-Meier Analysis|Duration of objective response (CR [+CRi; leukemia] + PR), defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).|Up to approximately 2 years|Participants with objective response (CR [+CRi; leukemia] + PR)|||months||Full Range|Median
2673508|NCT01461538|Secondary|Complete Remission (CR) Rate by Investigator|Percentage of participants who achieved a best response of CR per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).|Up to approximately 3 years|Efficacy-evaluable population|||percentage of participants||95% Confidence Interval|Number
2673509|NCT01461538|Primary|Objective Response Rate (ORR) by Investigator|Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).|Up to approximately 3 years|Efficacy-evaluable population|||percentage of participants||95% Confidence Interval|Number
2673510|NCT01461499|Secondary|Change in the Serum Insulin Level||baseline and 24 weeks|||||||
2673511|NCT01461499|Secondary|Change in the Plasma Renin Activity||baseline and 24 weeks|||||||
2673512|NCT01461499|Secondary|Change in the Urinary Angiotensinogen Level|Change in the urinaryurinary angiotensinogen level from the baseline|baseline and 24 weeks||||percentage of change UATGCR||95% Confidence Interval|Mean
2673513|NCT01461499|Primary|Reduction in Albuminuria|Change in the urinary albumin to creatinine ratio (UACR) from the baseline|baseline and 24 weeks||||percentage of UACR change||95% Confidence Interval|Mean
2673514|NCT01461473|Secondary|Mean Relative Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound|Mean relative flow-mediated vasodilatation (FMD) of the brachial artery (i.e., the mean change in brachial artery diameter from baseline to the value that is obtained after the cuff deflation, divided by the baseline value and multiplied by 100) as measured by vascular ultrasound (VU) at the 6-month visit|6 months||||percent change||Standard Deviation|Mean
2673515|NCT01461473|Secondary|Mean Absolute Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound|Mean absolute flow-mediated vasodilatation (FMD) of the brachial artery (i.e., the mean change in brachial artery diameter [in millimeters] from baseline to the value that is obtained after the cuff deflation) as measured by vascular ultrasound (VU) at the 6-month visit|6 months||||mm||Standard Deviation|Mean
2673548|NCT01461044|Secondary|Percentage of Participants With Reasons for Temporary Discontinuation||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were temporary discontinued.|||percentage of participants|||Number
2673516|NCT01461473|Secondary|Ratio of NMAP to Daytime Mean Arterial Pressure at 6 Months|Ratio of NMAP to daytime mean arterial pressure, expressed as a percentage at the 6 month visit for PAP and OA arms. The ratio is calculated by dividing the NMAP by the daytime mean arterial pressure; the result is then multiplied by 100 to obtain a percentage.|6 months|Two participants in the PAP arm and 1 participant in the OA arm did not have sufficient daytime MAP data to calculate the ratio of NMAP to daytime MAP at 6 months|||percentage of NMAP to daytime MAP||Standard Deviation|Mean
2673517|NCT01461473|Secondary|Ratio of Nocturnal Mean Arterial Pressure (NMAP) to Daytime Mean Arterial Pressure at 2 Months|Ratio of NMAP to mean daytime arterial pressure, expressed as a percentage at the 2 month visit for PAP and OA arms. The ratio is calculated by dividing the NMAP by the daytime mean arterial pressure; the result is then multiplied by 100 to obtain a percentage.|2 months|31 participants in the Positive Airway Pressure arm and 29 participants in the Oral Appliance arm failed to return for 24-hour ambulatory blood pressure monitoring at the two-months time point, but did return at the six-month time point for blood pressure monitoring at the six-month time point and to complete the study.|||percentage of NMAP to daytime MAP||Standard Deviation|Mean
2673518|NCT01461473|Secondary|Nocturnal Mean Arterial Blood Pressure (NMAP) at 6 Months|Nocturnal mean arterial blood pressure as recorded by 24-hour ambulatory blood pressure monitoring after approximately 6 months of treatment|6 months||||mmHg||Standard Deviation|Mean
2673519|NCT01461473|Primary|Nocturnal Mean Arterial Blood Pressure (NMAP) at 2 Months|Mean arterial blood pressure during the sleep period as recorded by 24-hour ambulatory blood pressure monitoring after approximately 2 months of treatment|2 months|31 participants in the Positive Airway Pressure arm and 29 participants in the Oral Appliance arm failed to return for 24-hour ambulatory blood pressure monitoring at the two-months time point, but did return at the six-month time point for blood pressure monitoring at the six-month time point and to complete the study.|||mmHg||Standard Deviation|Mean
2673520|NCT01461369|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale.|"The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing No Pain and 100 mm representing Worst Pain Imaginable.~The VAS pain intensity difference is calculated as the average of the VAS pain intensity scores at Weeks 2, 6, and 12 minus the VAS pain intensity at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the times specified.|||mm||Standard Error|Least Squares Mean
2673521|NCT01461369|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total (Composite) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score.|"Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total (composite) WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty.~The total (composite) WOMAC score difference was calculated as the total (composite) WOMAC score assessed at Weeks 2, 6, and 12 minus the total (composite) WOMAC score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the times specified.|||mm||Standard Error|Least Squares Mean
2673522|NCT01461369|Secondary|Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Weeks 2, 6, and 12 minus the average of the WOMAC pain subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2673523|NCT01461369|Secondary|Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 6 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 6|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2673524|NCT01461369|Secondary|Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 2 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 2|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2673525|NCT01461369|Primary|Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score.|"The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain.~The WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline."|Baseline to Week 12/Early Termination|Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug and had available measurements at the time specified.|||mm||Standard Error|Least Squares Mean
2673526|NCT01461096|Secondary|Time to First New Persistent Oral HPV Infection of Vaccine Types Detected From Oral Rinse|"The outcome for this evaluation was time to the first new persistent infection of any of oral HPV 6, 11, 16, or 18. Persistent infection was defined as an infection confirmed by positive oral HPV PCR results at 2 consecutive visits at least 16 weeks apart without an intervening negative result. A participant who had a positive measurement on his/her last measurement with no consecutive confirmatory measurement was considered as having a persistent infection. Participants with pre-existing HPV infection at baseline were evaluable for the primary endpoint if they were PCR negative for at least one of the four vaccine HPV types at baseline.~NOTE: Use 5th and 10th percentiles in years from baseline to the first new persistent infection as the summary measure."|From baseline to participant's last study visit, for up to 4 years|mITT population wherein all participants who received at least one dose of vaccine and all first new persistent infections that began after the first vaccination were included.|||Years||95.1% Confidence Interval|Number
2673527|NCT01461096|Secondary|Number of Participants With Grade 3 or 4 Adverse Events (AEs) That Were Possibly, Probably, or Definitely Related to the Vaccine, as Determined by the Local Investigator|To grade diagnoses, signs and symptoms, and laboratory results, sites must refer to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004 (Clarification, august 2009).|From baseline to participant's last study visit, for up to 4 years|mITT population including all participants who received at least one dose of vaccine.|||Participants|||Count of Participants
2673528|NCT01461096|Secondary|Number of Participants With Anal Cytological Abnormality Occurrences|Anal cytologic abnormalities include: atypical squamous cells undetermined significance (ASCUS), atypical squamous cells favor high-grade SIL/squamous cell carcinoma (ASC-H), low-grade squamous intraepithelial lesion/mild dysplasia/HPV (LSIL), or high-grade SIL/moderate dysplasia to severe dysplasia/carcinoma in situ/features of invasion (HSIL).|At baseline, Week 52, Week 104 and Week 156|mITT population including all participants who received at least one dose of vaccine.|||Participants|||Count of Participants
2673529|NCT01461096|Secondary|Number of Participants With Biopsy-proven High-grade Anal Intraepithelial Neoplasia (HGAIN) Occurrences and Reoccurrences After Week 52|HGAIN was defined as AIN2 (moderate dysplasia, with no mention of AIN grade III), AIN3 (severe dysplasia, carcinoma in-situ, or AIN grade II/III), high grade AIN not specified, or adenocarcinoma in situ found in the intra-anal or perianal region.|From Week 52 to participant's last study visit, for up to 4 years|mITT population including all participants who received at least one dose of vaccine.|||Participants|||Count of Participants
2673530|NCT01461096|Primary|Time to the First New Persistent Infection of HPV 6, 11, 16, or 18|"The outcome for this evaluation was time to the first new persistent infection of any of HPV 6, 11, 16, or 18. Persistent infection was defined as an infection confirmed by positive anal HPV PCR results at 2 consecutive visits at least 16 weeks apart without an intervening negative result. A participant who had a positive measurement on his/her last measurement with no consecutive confirmatory measurement was considered as having a persistent infection. Participants with pre-existing HPV infection at baseline were evaluable for the primary outcome if they were PCR negative for at least one of the four vaccine HPV types at baseline.~NOTE: Use 5th and 10th percentiles in years from baseline to the first new persistent infection as the summary measure."|From baseline to participant's last study visit, for up to 4 years|The efficacy analysis for persistent anal HPV employed a modified intent-to-treat (mITT) approach wherein all participants who received at least one dose of vaccine and all first new persistent infections that began after the first vaccination were included.|||Years||95.1% Confidence Interval|Number
2673531|NCT01461057|Primary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.|From randomization of first participant to end of study (approximately 6 years)|Safety population included all participants who received at least one dose of study treatment.|||participants|||Number
2673532|NCT01461057|Primary|Percentage of Participants With Day 43 Serum Pertuzumab Trough Concentrations (Cmin) Greater Than or Equal to (>=) 20 Microgram Per Milliliter (mcg/mL)||Day 43|The primary pharmacokinetic (PK) analysis population consisted of all participants with a measurable PK samples on Day 43.|||percentage of participants||95% Confidence Interval|Number
2673533|NCT01461044|Secondary|Percentage of Participants Who Received Induction Therapy in Combination With Bevacizumab||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population.|||percentage of participants|||Number
2673534|NCT01461044|Secondary|Percentage of Participants Who Maintained Bevacizumab Beyond the First Progressive Disease||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were available for this evaluation.|||percentage of participants|||Number
2673535|NCT01461044|Primary|Percentage of Participants Who Received First-Line Endocrine Therapy at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants|||Number
2673536|NCT01461044|Primary|Percentage of Participants With Previous and Concurrent Disease at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants|||Number
2673537|NCT01461044|Primary|Percentage of Participants With Ki67 (MiB1) at the Time of Local or Metastatic Progression|The Ki67 (MiB1) a prognostic marker, is used to evaluate the proliferative activity of breast cancer. Percentage of participants with < or >=10% and unknown were reported. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants|||Number
2673538|NCT01461044|Primary|Percentage of Participants With Mitotic Index (MI) at the Time of Local or Metastatic Progression|MI is an indirect measure of cell proliferation that has been demonstrated to be a strong predictor of outcome for several human and canine cancers. Percentage of participants that reported a low, intermediate, high and unknown indices were included. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants|||Number
2673539|NCT01461044|Primary|Percentage of Participants With Negative HER2 Status at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants|||Number
2673540|NCT01461044|Primary|Percentage of Participants With HR Status at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants|||Number
2673541|NCT01461044|Primary|Percentage of Participants With Cross Results for Both ER and PR at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants|||Number
2673542|NCT01461044|Primary|Percentage of Participants With Progesterone Receptors (PR) at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants|||Number
2673543|NCT01461044|Primary|Percentage of Participants With Estrogen Receptors (ER) at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants|||Number
2673544|NCT01461044|Primary|Percentage of Participants With Visceral Involvement at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population.|||percentage of participants||95% Confidence Interval|Number
2673545|NCT01461044|Primary|Percentage of Participants Classified Based on Number of Metastatic Sites at the Time of Local or Metastatic Progression|Percentage of participants that reported metastatic disease in less than or equal to (<=) 3 sites or greater than (>) 3 sites were assessed. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of metastatic sites.|||percentage of participants||95% Confidence Interval|Number
2673546|NCT01461044|Secondary|Percentage of Participants With Reasons for Definitive Discontinuation||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were definitive discontinued.|||percentage of participants|||Number
2673547|NCT01461044|Secondary|Percentage of Participants With Definitive Discontinuation||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were temporary discontinued.|||percentage of participants|||Number
2673754|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|2.5 weeks (or after treatment session 5)|||||||
2673549|NCT01461044|Secondary|Percentage of Participants With Temporary Discontinuation||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population. Here number of participants were those who were temporary discontinued.|||percentage of participants|||Number
2673550|NCT01461044|Secondary|Duration of Bevacizumab as First Line Treatment||From start of bevacizumab until 18 months after inclusion (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population.|||months||Full Range|Median
2673551|NCT01461044|Primary|Percentage of Participants With Metastatic Disease at Identified Metastatic Sites at the Time of Local or Metastatic Progression|Metastatic diseases were identified at bone, lung, liver, central nervous system, soft tissue, lymph nodes, skin, pleura and other sites. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population.|||percentage of participants||95% Confidence Interval|Number
2673552|NCT01461044|Primary|Percentage of Participants With Breast Cancer (BRCA) Mutation at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of BRCA mutation.|||percentage of participants|||Number
2673553|NCT01461044|Primary|Mean Body Mass Index (BMI) at the Time of Local or Metastatic Progression|BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of BMI which was measured in kg/m^2.|||kg/m^2||Standard Deviation|Mean
2673554|NCT01461044|Primary|Mean Height at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of height.|||centimeters||Standard Deviation|Mean
2673555|NCT01461044|Primary|Mean Body Weight at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of body weight.|||kilograms||Standard Deviation|Mean
2673556|NCT01461044|Primary|Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at the Time of Local or Metastatic Progression|ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on a 5 point scale: 0 equals (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, but ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than [>] 50 percentage [%] of waking hours [h]), capable of all self care, but unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any selfcare, totally confined to bed or chair and 5=Dead. Only participants that reported in any of the specified scale was reported. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of ECOG PS.|||percentage of participants|||Number
2673557|NCT01461044|Primary|Percentage of Participants With Menopausal Status at the Time of Local or Metastatic Progression|Menopausal status included premenopausal and menopausal. Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the evaluation of menopausal status.|||percentage of participants|||Number
2673558|NCT01461044|Primary|Mean Age at the Time of Local or Metastatic Progression|Time of local or metastatic progression is the time of advanced or metastatic diagnosis which was assessed at inclusion or baseline (the time after the retrospective phase and at the start of prospective phase).|At the time of Advanced or Metastatic Diagnosis (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population.|||years||Standard Deviation|Mean
2673559|NCT01461044|Primary|Disease-Free Interval|Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Disease free interval was observed retrospectively and assessed at inclusion period or baseline (the time after the retrospective phase and at the start of prospective phase).|From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for this outcome measure.|||months||Full Range|Median
2673560|NCT01461044|Primary|Percentage of Participants Who Were Disease-Free for at Least 24 Months After Initial Diagnosis|Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Percentage of participants who were disease-free for at least 24 months were reported.|From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2673561|NCT01461044|Secondary|Overall Survival (OS)|OS was defined as the time between the first administration of bevacizumab and death from any cause and participants still alive at the end of the study were censored at the last consultation or last contact date.|From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population.|||months||95% Confidence Interval|Median
2673562|NCT01461044|Secondary|Percentage of Participants With Death|Overall survival (OS) was defined as the time between the first administration of bevacizumab and death from any cause and participants still alive at the end of the study were censored at the last consultation or last contact date.|From the first administration of bevacizumab to death from any cause (up to a maximum of 60.8 months including retrospective and prospective treatment)|Efficacy population.|||percentage of participants|||Number
2673563|NCT01461044|Secondary|Time to Progression|Objective tumor response was assessed using RECIST. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Participants who withdrew from the study early for insufficient therapeutic response without tumor assessment for PD were also included within the definition of PD. Time to progression was defined as the time from treatment start to PD. Participants who did not experience PD were censored from the last tumor assessment. Time to progression was estimated using Kaplan-Meier and expressed in months. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.|From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)|Efficacy population.|||months||95% Confidence Interval|Median
2673564|NCT01461044|Secondary|Progression-Free Survival|Progression-free survival was defined as the time from first dose of bevacizumab to documented PD or death from any cause, whichever occurred first. PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.|From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months, assessed retrospectively at Baseline)|Efficacy population.|||months||95% Confidence Interval|Median
2673565|NCT01461044|Secondary|Percentage of Participants With Disease Progression or Death|"Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death). PD was defined as the appearance of new lesion(s) or at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum obtained at Screening or during treatment."|From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)|Efficacy population.|||percentage of participants|||Number
2673566|NCT01461044|Secondary|Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)|Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR was defined as the disappearance of all target and non-target lesions, and confirmed PR was defined as at least at 30% decrease in the sum of the longest diameters of target lesions. Response was to be confirmed at follow-up assessment completed within 4 weeks of the first documented response. Inclusion (baseline) here was the time after the retrospective phase and at the start of prospective phase.|From first administration of bevacizumab to inclusion in the study (up to a maximum of 42.8 months , assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for the specified evaluation.|||percentage of participants||95% Confidence Interval|Number
2673567|NCT01461044|Primary|Percentage of Participants Who Were Disease-Free for at Least 12 Months After Initial Diagnosis|Disease free interval was expressed in months: (Date of diagnosis of metastatic disease - Date of initial diagnosis + 1) / 30.4375. Percentage of participants who were disease-free for at least 12 months were reported.|From initial diagnosis to the diagnosis of metastatic disease (up to a maximum of 260 months, assessed retrospectively at Baseline)|Efficacy population. Here number of participants analyzed were those who were available for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2673568|NCT01461005|Secondary|Assessment of Back Pain Using the Oswestry Low Back Pain Disability Index (ODI).|ODI is a questionnaire that provides information on back and the affects on managing every day life by diving questions into 10 sections. The total possible score for each section is 0-5. The scores are then converted into percentages ranging from 0% (minimal disability) to 100% (maximum possible disability).|6 months||||score on a scale|||Number
2673569|NCT01461005|Secondary|Number of Participants With Improved Health as Measured by the EuroQOL Health Related Qualify of Life- 5 Dimensions-3 Level (EQ-5D-3L) Health Questionnaire Compared to Baseline.|"The EQ-5D-3L is a standardized instrument used as a measure of health outcomes. It contains questions in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and provides a simple descriptive profile and single index for health status preference. In addition, there is a Visual Analog Scale (VAS). The VAS is the participant's rating of their health on a scale of 0 worst imaginable health state to 100 best imaginable health state."|Pre-Op, 6 weeks, 6 months, 12 months, and 24 months||||participants|||Number
2673570|NCT01461005|Secondary|Measurement of Left Leg Pain as Assessed by Visual Analog Scale|Left leg pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)|6 months||||units on a scale|||Number
2673571|NCT01461005|Secondary|Measurement of Right Leg Pain as Assessed by Visual Analog Scale|Right leg pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)|6 months||||units on a scale|||Number
2673572|NCT01461005|Secondary|Measurement of Lower Back Pain as Assessed by Visual Analog Scale|Lower back pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)|6 months||||units on a scale|||Number
2673573|NCT01461005|Primary|Number of Participants Who Have an Incidence of Serious or Device Related Adverse Events Due to Device or Procedure.|The safety endpoint is defined as the incidence of serious or device related adverse events attributable to the device or procedure. Reoperations, revisions or removals of the Dynamic Stabilization System (DSS) System implant will be evaluated.|6 months||||Participants|||Count of Participants
2673575|NCT01460940|Secondary|Assess the Safety and Tolerability of Combined Lenalidomide and Panobinostat in Patients With Previously Treated Hodgkin's Lymphoma.|Safety and tolerability will be assessed for patients using the NIH-NCI Common Terminology Criteria (CTCAE) version 4.0|up to 24 months|Grade 3-4 toxicities|||percentage of patients|||Number
2673576|NCT01460940|Primary|Determine the Overall Response Rate (ORR), Including Complete Responses (CR) and Partial Responses (PR)|Overall response rate (CR + PR) will be determined using the International response criteria with combined panobinostat and lenalidomide in patients with relapsed or refractory Hodgkin's lymphoma.|up to 24 months||||percentage of patients|||Number
2673577|NCT01460927|Primary|Fitzpatrick Classification of Wrinkling and Degree of Elastosis.|"At each of the specified time points, photographs of the treated areas will be taken. The photography angles will include a global frontal photo and the right and left sides of the face at 45° and/or 90°. In addition, close up photos will be taken of specific facial zones, e.g., the peri orbital wrinkles.~Observing changes to the surface by visual and photographic analysis based on the score of 2-6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis. (Lasers Surg Med 2003;33(4):232 42)~Score Wrinkling & Degree of Elastosis 1-3 Fine wrinkles (rhytides) and Mild Elastosis (fine textural changes with subtly accentuated skin lines) 4-6 Fine to moderate depth wrinkles, moderate number of lines and Moderate Elastosis (distinct papular elastosis [individual papules with yellow translucency under direct lighting] and dyschromia)"|Baseline, Pre Treatment 4, Pre Treatment 8, 1 Month FU, 3 Month FU|Per protocol|||Fitzpatrick Classification Scale||Full Range|Mean
2673578|NCT01460901|Secondary|Maximum Tumor Response (RECIST 1.1)|Pre and post-therapy evaluation by modalities consistent with prior disease evaluation in each patient. When possible, tumors were assessed per Response Evaluation Criteria In Solid Tumors (RECIST v1.0): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >/=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) at least a 20% increase in the sum of diameters of target lesions; Stable Disease (SD) neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Bone marrow aspirations and biopsies were evaluated by histopathology and appropriate immunohistochemistry; Modified Curie score was used for MIBG evaluation.|1 year||||Response|||Number
2673579|NCT01460901|Secondary|Peak Viral Specific SFU/2x10e5 Mononuclear Cells Per Well|"The following analyses were performed on peripheral blood samples from patients at protocol assigned time points (pre-infusion, post-infusion at 4 hrs, weeks 1,2,4,6 and 8, month 3, 6 and 12:~ELISPOT assay for CMV, Adenovirus and EBV specific CTL reported as SFU (spot forming unit) per 2x10e5 mononuclear cells"|up to 1 year||||SFU/2x10e5 Mononuclear Cells|||Number
2673580|NCT01460901|Primary|Death Within 8 Weeks of Infusion||8 weeks||||participants|||Number
2673581|NCT01460901|Primary|Peak Transgene Copy Number Per 1000ng PBMC DNA|Peak Transgene Copy Number per 1000ng PBMC DNA from peripheral blood samples measured during study participation.|1 year|Evaluable patients|||Transgene Copy per 1000ng PBMC DNA|||Number
2673582|NCT01460901|Primary|Number of Participants With Immediate and Short Term Toxicity of Infusion Over 8 Weeks|"Immediate: Patients were monitored following infusion to assess for toxicity related to infusion. Potential toxicities related to cellular therapy infusions, such as allergic reaction to the cellular product or cryopreservation media, hemolytic reactions, volume overload, and hemodynamic instability, were monitored.~Short Term: Patients were monitored for 8 weeks for short term toxicity related to infusion. Such adverse reactions monitored were acute graft versus host disease and cytokine release syndrome."|Post infusion week 8||||Participants|||Count of Participants
2673583|NCT01460875|Secondary|Clinical Role of Tumor Sensitivity to Recombinant Interferon Alfa-2b Using Cellular Levels of Jak-STAT Signaling Intermediates|Define the clinical role of tumor sensitivity to IFN-α, patient tumor biopsies taken prior to the administration of IFN-α will be systematically evaluated for cellular levels of Jak-STAT signaling intermediates.|Baseline and every other week prior to recombinant interferon alfa-2b administration|Data was not collected and analyzed for outcome measure||||||
2673584|NCT01460875|Secondary|Effect of Dose-reduction on Interferon Alfa Gene Expression at Dose Level 4MU|Evaluated using microarray analysis of patient PBMCs. Compared between doses using the Wilcoxon signed rank test.|4 hours post therapy||||fold increase||Full Range|Median
2673585|NCT01460875|Secondary|Effect of Dose-reduction on Interferon Alfa Gene Expression Through Marker CD69|Evaluated using microarray analysis of patient PBMCs. Compared between doses using the Wilcoxon signed rank test.|4 hours post therapy||||fold increase||Full Range|Median
2673586|NCT01460875|Secondary|Effect of Dose-reduction on Interferon Alfa Gene Expression|Evaluated using microarray analysis of patient PBMCs. Compared using the Wilcoxon signed rank test for the dose 4MU/m2|1 hour post therapy||||fold increase||Full Range|Median
2673587|NCT01460875|Secondary|Effect of Dose-reduction on Expression of Interferon Alfa Stimulated Genes|Evaluated using microarray analysis of patient PBMCs. Compared using the Wilcoxon signed rank test for the dose 10MU/m2|1 hour post therapy||||fold change||Full Range|Median
2673588|NCT01460875|Secondary|Percentage of Patients With Correlation Between STAT1 Phosphorylation and Interferon Alfa Gene Regulation|Levels of p-STAT1 in PBMCs were analyzed just prior to IFN-a-2b administration to determine levels that remained stable or increased over the course of dose reduction.|Prior to treatment and 1 and 4 hours post therapy on day 1 every other week during the first 12 weeks, and then every 3 months||||percentage of patients|||Number
2673589|NCT01460875|Secondary|Number of Patients With Adverse Events|Determine the tolerability of adjuvant IFN-α-2b administered at an optimized dose in terms of the toxicities that are observed and the ability of patients to receive a full year of therapy.|up to 1 year||||Participants|||Count of Participants
2673590|NCT01460875|Primary|Level of Activated STAT1(Phospho-STAT1)|Mean and 95% confidence interval will be summarized for phospho-STAT1 at a lower dose and the standard dose. The phospho-STAT1 will also be compared between the dose levels.|up to 4 weeks||||MU/m2||95% Confidence Interval|Mean
2673591|NCT01460732|Secondary|Dippers Defined by ABPM and HBPM-Nocturnal|As Dippers are defined the patients who displayed a nocturnal fall (Daytime-Nighttime BP/Daytime BP) in Systolic and/or Diastolic Blood Pressure by 10% or more, by each method. The rest of patients, with a nocturnal fall by less than 10% or even a rise of BP, are consequently defined as Non-Dippers.|2 weeks|All patients who had their Daytime and Nocturnal BP assessed by both methods.|||percentage of patients|||Number
2673755|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|26 week follow up|||||||
2673592|NCT01460732|Primary|Asleep Diastolic Ambulatory Blood Pressure Measurement|An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.|2weeks||||mmHg||Standard Deviation|Mean
2673593|NCT01460732|Primary|Asleep Systolic Ambulatory Blood Pressure Measurement|An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.|2weeks||||mmHg||Standard Deviation|Mean
2673594|NCT01460732|Primary|Awake Diastolic Ambulatory Blood Pressure Measurement|An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.|2 weeks||||mmHg||Standard Deviation|Mean
2673595|NCT01460732|Primary|Awake Systolic Ambulatory Blood Pressure Measurement|An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.|2 weeks||||mmHg||Standard Deviation|Mean
2673596|NCT01460732|Primary|Asleep Diastolic Home Blood Pressure Measurement|Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.|2 weeks||||mmHg||Standard Deviation|Mean
2673597|NCT01460732|Primary|Asleep Systolic Home Blood Pressure Measurement|Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.|2 weeks||||mmHg||Standard Deviation|Mean
2673598|NCT01460732|Primary|Awake Diastolic Home Blood Pressure Measurement|Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.|2 weeks||||mmHg||Standard Deviation|Mean
2673599|NCT01460732|Primary|Awake Systolic Home Blood Pressure Measurement|Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.|2 weeks||||mmHg||Standard Deviation|Mean
2673600|NCT01460719|Primary|Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event|An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with study vaccine withdrawn due to an AE was summarized.|Up to Vaccination 4 (~Day 90)|All enrolled participants|||Percentage of participants|||Number
2673601|NCT01460719|Primary|Percentage of Participants With a Vaccine-related Serious Adverse Event|A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs an inpatient hospitalization, is a congenital anomaly or birth defect, is an overdose, is a cancer, or is another important medical event. The percentage of participants with any SAE that was deemed by the investigator to be possibly, probably, or definitely related to study vaccine was summarized.|Up to ~28 days after Vaccination 4 (~Day 118)|All enrolled participants|||Percentage of participants|||Number
2673602|NCT01460719|Primary|Percentage of Participants With a Serious Adverse Event|A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs an inpatient hospitalization, is a congenital anomaly or birth defect, is an overdose, is a cancer, or is another important medical event. The percentage of participants with any SAE was summarized.|Up to ~28 days after Vaccination 4 (~Day 118)|All enrolled participants|||Percentage of participants|||Number
2673603|NCT01460719|Primary|Percentage of Participants With a Systemic Adverse Event|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with any systemic AE was summarized.|Up to ~28 days after Vaccination 4 (~Day 118)|All enrolled participants|||Percentage of participants|||Number
2673604|NCT01460719|Primary|Percentage of Participants With an Injection-site Adverse Event|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with any injection-site AE was summarized.|Up to 5 days after any vaccination|All enrolled participants|||Percentage of participants|||Number
2673605|NCT01460719|Primary|Percentage of Participants With an Adverse Event|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the product is also an adverse experience. The percentage of participants with any AE was summarized.|Up to ~28 days after Vaccination 4 (~Day 118)|All enrolled participants|||Percentage of participants|||Number
2673606|NCT01460719|Primary|Geometric Mean Fold Rise (GMFR) of the VZV-specific Immune Responses Measured by VZV Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISPOT)|The VZV ELISPOT assay detects IFN-γ-secreting, VZV-specific cells from peripheral blood mononuclear cells (PBMCs). The unit of measure of the assay is ELISPOT cell count / 10^6 PBMCs, and is expressed as geometric mean count (GMC). The GMFR is GMC at ~28 days after Vaccination 4 / GMC on Day 1.|Prevaccination (Day 1) and ~28 days after Vaccination 4 (~Day 118)|Vaccinated participants having valid results at Baseline (Day 1) and/or at ~28 days after Vaccination 4.|||Ratio||90% Confidence Interval|Geometric Mean
2673607|NCT01460628|Secondary|Brown Attention Deficit Disorder Scale (BADDS)|This is a normed and validated measure of ADHD-related executive function impairments. The clinician administered scale measures five clusters of executive function including 1) organizing and activating for work, 2) sustaining attention and concentration, 3) sustaining alertness, effort, and processing speed, 4) managing affective interference, and 5) using working memory and accessing recall. The frequency and severity of each of the 40 items is rated on a scale of 0 to 3, with the total scores ranging from 0-120 and higher scores indicating worse symptoms.|4 weeks||||units on a scale||Inter-Quartile Range|Median
2673608|NCT01460628|Secondary|Patient Health Questionnaire-9 (PHQ-9)|The PHQ-9 is the self-administered form of the Primary Care Evaluation of Mental Disorders (PRIME-MD), a widely used instrument designed to screen for psychiatric illnesses in primary-care settings. This 9-item instrument assesses mood, depressive symptoms, and suicidal ideation. The range of total scores is 0-27 with higher scores indicating worse symptoms. Generally, scores 5-9 indicate mild depression, 10-14 indicate moderate depression, and 15+ indicate moderately severe or severe depression.|4 weeks||||units on a scale||Inter-Quartile Range|Median
2673609|NCT01460628|Secondary|Symptom Checklist-10 Anxiety|"The SCL-10 anxiety subscale, developed from the refinement of the Hopkins Symptom Checklist (HSCL), consists of 10 questions focused on how much discomfort symptoms of anxiety (e.g. nervousness or shaking inside) have caused in the past two weeks. Each question is answered on a scale from 0-4, and answers are averaged for a total score between 0-4 with higher scores indicating more anxiety."|4 weeks||||units on a scale||Inter-Quartile Range|Median
2673610|NCT01460628|Secondary|Hot Flash Frequency (24-hr Period)|The Daily Vasomotor Symptom Diary consists of a 7-day scale on which the subject records the total number of hot flushes they experience on a daily basis. Weekly averages for a 24-hour period are calculated.|4 weeks||||# of hot flashes||Inter-Quartile Range|Median
2673611|NCT01460628|Secondary|Epsworth Sleepiness Scale (ESS)|This self-report scale is widely used as a subjective measure of sleepiness. This 8 item instrument yields a total score ranging from 0-24 with higher scores indicating worse symptoms.|4 weeks||||units on a scale||Inter-Quartile Range|Median
2673612|NCT01460628|Primary|Brief Fatigue Inventory (BFI)|This is a widely used self-report instrument to assess the severity of fatigue and the impact of fatigue on daily functioning. This 9 item instrument yields a global fatigue score ranging from 0-10 with higher scores indicating worse symptoms. .|4 weeks||||units on a scale||Inter-Quartile Range|Median
2673613|NCT01460628|Primary|Menopause Quality Of Life Questionnaire (MENQOL) Physical Domain Subscale|This is a widely used self-report instrument to determine differences in quality of life among menopausal women and to measure changes in their quality of life over time. Four domain scores are calculated from the 29-item instrument. The physical domain subscale has 16 questions and a range from 0-8 with higher scores indicating worse symptoms.|4 weeks||||units on a scale||Inter-Quartile Range|Median
2673614|NCT01460446|Secondary|The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) Score and the Diabetes Treatment Satisfaction Questionnaire for Change From Baseline (DTSQc) Score|"The Diabetes Treatment Satisfaction Questionnaire at Baseline (DTSQs) contains 6 items which can be scored from 0='very bad' to 6='very good'. The total score is the sum of the scores of the 6 items and ranges from 0 to 36. A higher score indicates more satisfaction. This questionnaire was administered at Baseline only.~The Diabetes Treatment Satisfaction Questionnaire for change from Baseline (DTSQc) to study end contains 6 items which can be rated from -3='much worse now' to 3='much better now'). The total score is the sum of the scores of the 6 items and ranges from -18 to 18. A higher score indicates more satisfaction. This questionnaire was administered at the end of the study (Week 24) only."|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study.|||Units on a scale||Standard Deviation|Mean
2673615|NCT01460446|Secondary|Change in the Hypoglycemia Fear Survey (HFS-II) Score From Baseline to Week 24|The Hypoglycemia Fear Survey-II (HFS-II) contains 33 items (15 items regarding behavior and 18 items regarding worry) which can be rated from 0='never' to 4='always'). The total HFS-II score ranges from 0 to 132 with a higher score indicating more fear. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.|||Units on a scale||Standard Deviation|Mean
2673616|NCT01460446|Secondary|Change in the Problem Area in Diabetes (PAID) Scale Score From Baseline to Week 24|The Problem Area in Diabetes (PAID) scale contains 20 items which can be rated from 0='not a problem' to 4='serious problem'. The total PAID scale score ranges from 0 to 80 with a higher score indicating more diabetes-related problems. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.|||Units on a scale||Standard Deviation|Mean
2673617|NCT01460446|Secondary|Number of Participants With None, Mild, Moderate, Moderately Severe, and Severe Depression at Baseline and Week 24|The Major Depression Disorder (MDD) scale is derived from the Patient Health Questionnaire depression scale (PHQ-8) and was used to categorize participants in regard to the severity of their depression. There are 5 categories on the MDD scale: None, mild, moderate, moderately severe, and severe. The category for each participant is determined from their PHQ-8 score. A total PHQ-8 score of 0 to 4 represents no significant depressive symptoms. A total PHQ-8 score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe. A higher score indicates more depression.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study.|||Participants|||Number
2673618|NCT01460446|Secondary|Change in the Patient Health Questionnaire Depression Scale (PHQ-8) Score From Baseline to Week 24|The Patient Health Questionnaire depression scale (PHQ-8) contains 8 items which can be rated from 0='not at all' to 3='nearly every day'. The total PHQ-8 score is the sum of the responses to the 8 items and ranges from 0 to 24. A lower score indicates less depression. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All randomized participants who had data available for analysis.|||Units on a scale||Standard Deviation|Mean
2673619|NCT01460446|Secondary|Change in Carbohydrate Counting Accuracy From Baseline to Week 24|Participants were asked to assess the carbohydrate content (grams) of 10 standardized meals by using a set of Dose Adjustment for Normal Eating (DAFNE) plates, which provide standardized photographs of meals with known carbohydrate values. The mean meal error (MME), an indicator of accuracy, and mean meal absolute error (MMAE), an indicator of variability were calculated from their responses. The MME is defined as the mean of the differences between the estimated carbohydrate content and the actual carbohydrate content over the 10 DAFNE plates. A negative MME indicates an underestimation and a positive MME indicates an overestimation of the actual carbohydrate content. The MMAE is defined as the mean of the absolute value of the differences between the estimated carbohydrate content and the actual carbohydrate content over the 10 DAFNE plates. The MMAE is ≥ 0 with a lower value indicating a better ability to estimate the actual carbohydrate content.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study and had data available for analysis.|||Grams||Standard Deviation|Mean
2673620|NCT01460446|Secondary|Correct and Incorrect Use of Insulin:Carbohydrate Ratio (I:CHO) and Insulin Sensitivity Factor (ISF) Advice by Participants Using the Aviva Nano Blood Glucose Meter During the Study|Participants using the Aviva Nano blood glucose meter received individualized advice in how to use their insulin:carbohydrate ratio (I:CHO) and insulin sensitivity factor (ISF) values to determine their insulin dose. The I:CHO ratio advice was considered to have been used correctly if the meal bolus dose the participant indicated in his/her patient diary was in accordance with the dose which could be calculated based upon the participant's total carbohydrate intake and the I:CHO ratio. The ISF advice was considered to have been correctly used if the correction bolus dose the participant indicated in his/her patient diary was in accordance with the dose which could be calculated based upon the participant's blood glucose target, current blood glucose value, and the ISF.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study. Results are only reported for participants using the Aviva Nano blood glucose meter who had data available for analysis.|||Number of advices per day||Standard Deviation|Mean
2673621|NCT01460446|Secondary|Number of Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advices Modified Per Day by Participants During the Study|Participants using the Accu-Chek® Aviva Expert blood glucose meter were encouraged to use the Bolus Advisor utility incorporated into the meter. A bolus opportunity occurs, for example, just before eating a meal.|Baseline to Week 24|Intent-to-treat population: All randomized participants.|||Number of advices modified per day||Standard Deviation|Mean
2673622|NCT01460446|Secondary|Percentage of Bolus Opportunities Where the Accu-Chek® Aviva Expert Blood Glucose Meter Bolus Advisor Was Used During the Study|Participants using the Accu-Chek® Aviva Expert blood glucose meter were encouraged to use the Bolus Advisor utility incorporated into the meter. A bolus opportunity occurs, for example, just before eating a meal.|Baseline to Week 24|Intent-to-treat population: All randomized participants.|||Percentage of opportunities||Standard Deviation|Mean
2673623|NCT01460446|Secondary|Change in the Mean Amplitude of Glucose Excursion (MAGE) From Baseline to Week 24|Approximately half of the investigational sites monitored glucose levels in participants enrolled in this study using the DexCom Seven® Plus Continuous Glucose Monitoring device. The device provides glucose measurements every 5 minutes for up to 7 days. The system contains a sensor, transmitter, and receiver. The sensor is a flexible round wire that goes under the skin to read glucose levels. The transmitter snaps into the sensor and wirelessly sends glucose readings to the receiver. Data was obtained from approximately one-third of participants and was used to calculate MAGE. Data were collected in the 3 days prior to Baseline and the Week 24 visit. The standard deviation of the blood glucose measurements in each 3-day period was calculated. For each glucose measurement, the difference from the previous reading was calculated. Absolute differences smaller than the standard deviation were discarded. MAGE is the mean of the remaining difference scores.|3 days prior to Baseline to Week 24|Intent-to-treat population: All randomized participants with continuous glucose monitoring data at Baseline and at Week 24 who completed the study.|||mg/dL||Standard Deviation|Mean
2673624|NCT01460446|Secondary|Number of Symptomatic Hypoglycemic Episodes Per Subject Year From Screening to Baseline and From Week 23 to Week 24|A symptomatic hypoglycemic episode was defined as an event with symptoms consistent with hypoglycemia which was confirmed by a blood glucose reading < 70 mg/dL (3.9 mmol/L). Symptoms might include but were not limited to sweating, dizziness, lightheadedness, tremors, nervousness, hunger, headaches, and weakness or tiredness.|Screening to Week 24|Intent-to-treat population: All randomized participants who completed the study.|||Episodes per year||Standard Deviation|Mean
2673625|NCT01460446|Secondary|Percentage of Blood Glucose Measurements Within the Blood Glucose Target Range From Screening to Baseline and From Week 23 to Week 24|Participants measured their blood glucose at least 3-4 times daily throughout the study. The mean blood glucose level was calculated for each 3-day period from Baseline to Week 24 and the percentage of 3-day blood glucose levels with the target range of 70-180 mg/dL (3.9-10 mmol/L) was calculated for the 2 reporting periods of Screening to Baseline and Week 23 to Week 24.|Screening to Week 24|Intent-to-treat population: All randomized participants who completed the study.|||Percentage of measurements||Standard Deviation|Mean
2673626|NCT01460446|Primary|Change in Glycosylated Hemoglobin A1c (HbA1c) From Baseline to Week 24|HbA1C was measured in blood samples at a central laboratory.|Baseline to Week 24|Intent-to-treat population: All randomized participants who completed the study.|||Percentage||Standard Deviation|Mean
2673627|NCT01460407|Primary|Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684|Tmax of LY2216684 was calculated during Period 1, when 18-mg LY2216684 was administered alone, and Period 2, when Clarithromycin was coadministered with LY2216684. The outcome was presented as geometric LS mean and the 90% CI. Geometric LS mean was controlled by participant and treatment.|Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10)|Full Analysis Set: Participants who received at least 1 dose of LY2216684.|||hours (h)||90% Confidence Interval|Median
2673628|NCT01460407|Primary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2216684|Cmax of LY2216684 was calculated during Period 1, when 18-mg LY2216684 was administered alone, and Period 2, when Clarithromycin was coadministered with LY2216684. The outcome was presented as geometric LS mean and the 90% CI. Geometric LS mean was controlled by participant and treatment.|Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10)|Full Analysis Set: Participants who received at least 1 dose of LY2216684.|||nanograms per milliliter (ng/mL)||90% Confidence Interval|Geometric Mean
2673629|NCT01460407|Primary|Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684|AUC0-∞ of LY2216684 was calculated during Period 1, when 18-mg LY2216684 was administered alone and Period 2, when Clarithromycin was coadministered with LY2216684. The outcome was presented as geometric Least Squares (LS) mean and the 90% Confidence Interval (CI). Geometric LS mean was controlled by participant and treatment.|Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10)|Full Analysis Set: Participants who received at least 1 dose of LY2216684.|||nanogram*hours per milliliter (ng*h/mL)||90% Confidence Interval|Geometric Mean
2673640|NCT01460342|Secondary|Patient Global Impression of Improvement (PGI-I) Scale at 12 Weeks|The PGI-I scale measured the participant's perception of improvement at the time of assessment compared with the start of treatment. Scores were 1 (Very much better), 2 (Much improved), 3 (Minimally improved), 4 (No change), 5 (Minimally worse), 6 (Much worse), and 7 (Very much worse).|12 Weeks|Randomized participants who received at least 1 dose of study drug.|||participants|||Number
2673630|NCT01460381|Secondary|Pharmacokinetics: Time to Maximum Observed Plasma Concentration (Tmax) of LY2216684 + Quinidine in CYP2C19 Poor Metabolizers|Blood samples were collected prior to and up to 120 hours following coadministration of LY2216684 and quinidine on Day 11 (Period 2) for the measurement of LY2216684 plasma concentrations.|Predose up to 120 hours post administration of quinidine|Participants who received at least 1 dose of LY2216684 and had evaluable LY2216684 plasma concentration data were included in the analysis.|||hours||Full Range|Median
2673631|NCT01460381|Secondary|Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2216684 + Quinidine in CYP2C19 Poor Metabolizers|Blood samples were collected prior to and up to 120 hours following coadministration of LY2216684 and quinidine on Day 11 (Period 2) for the measurement of LY2216684 plasma concentrations.|Predose up to 120 hours post administration of quinidine|Participants who received at least 1 dose of LY2216684 and had evaluable LY2216684 plasma concentration data were included in the analysis.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2673632|NCT01460381|Secondary|Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [(AUC(0-∞)] of LY2216684 + Quinidine in Cytochrome P450 (CYP)2C19 Poor Metabolizers (PM)|Blood samples were collected prior to and up to 120 hours following coadministration of LY2216684 and quinidine on Day 11 (Period 2) for the measurement of LY2216684 plasma concentrations.|Predose up to 120 hours post administration of quinidine|Participants who received at least 1 dose of LY2216684 and had evaluable LY2216684 plasma concentration data were included in the analysis.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2673633|NCT01460381|Primary|Pharmacokinetics: Time to Maximum Observed Plasma Concentration (Tmax) of LY2216684 in Cytochrome P450 (CYP)2C19 Extensive Metabolizers (EM) Versus Poor Metabolizers (PM)|Blood samples were collected prior to and up to 120 hours following dosing of LY2216684 on Day 1 (Period 1) for the measurement of LY2216684 plasma concentrations.|Predose up to 120 hours post administration of LY2216684|Participants who received at least 1 dose of LY2216684 and had evaluable LY2216684 plasma concentration data were included in the analysis. Participants who vomited within twice the median time to maximum observed drug concentration (tmax) following dosing of LY2216684 were excluded from the analysis.|||hours||Full Range|Median
2673634|NCT01460381|Primary|Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2216684 in Cytochrome P450 (CYP)2C19 Extensive Metabolizers (EM) Versus Poor Metabolizers (PM)|Blood samples were collected prior to and up to 120 hours following dosing of LY2216684 on Day 1 (Period 1) for the measurement of LY2216684 plasma concentrations.|Predose up to 120 hours post administration of LY2216684|Participants who received at least 1 dose of LY2216684 and had evaluable LY2216684 plasma concentration data were included in the analysis. Participants who vomited within twice the median time to maximum observed drug concentration (tmax) following dosing of LY2216684 were excluded from the analysis.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2673635|NCT01460381|Primary|Pharmacokinetics: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-∞)] of LY2216684 in Cytochrome P450 (CYP)2C19 Extensive Metabolizers (EM) Versus Poor Metabolizers (PM)|Blood samples were collected prior to and up to 120 hours following dosing of LY2216684 on Day 1 (Period 1) for the measurement of LY2216684 plasma concentrations.|Predose up to 120 hours post administration of LY2216684|Participants who received at least 1 dose of LY2216684 and had evaluable LY2216684 plasma concentration data were included in the analysis. Participants who vomited within twice the median time to maximum observed drug concentration (tmax) following dosing of LY2216684 were excluded from the analysis.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2673636|NCT01460368|Secondary|Part B: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) Corrected QT Intervals (Moxifloxacin)|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Least Squares (LS) means were calculated using mixed effects model with fixed effects for treatment, time, period, sequence, and the time-by-treatment interaction, random effects for participant, the participant-by-treatment interaction, and participant-by-time interaction.|Baseline, 2 and 4 hours|Participants who received at least 1 dose of Moxifloxacin or Placebo with evaluable QTcF data.|||milliseconds||90% Confidence Interval|Least Squares Mean
2673637|NCT01460368|Primary|Part B: Mean Change From Baseline in 12-lead Electrocardiogram (ECG) Corrected QT Intervals (LY2409021)|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. Least Squares (LS) means were calculated using mixed effects model with fixed effects for treatment, time, period, sequence, and the time-by-treatment interaction, random effects for participant, the participant-by-treatment interaction, and participant-by-time interaction.|Baseline, 2, 4, 6, 8, 12, and 24 hours|Participants who received at least 1 dose of LY2409021 or Placebo with evaluable Fridericia Correction Formula (QTcF) data.|||milliseconds||90% Confidence Interval|Least Squares Mean
2673638|NCT01460342|Secondary|Change From Baseline in Modified International Prostate Symptom Score (mIPSS) Score at 2 Weeks|The mIPSS Total Score was the sum of Questions 1 through 7 in the mIPSS questionnaire, which was a modified version of the IPSS questionnaire. Questions about the participant's urination experiences and prostate symptoms in the IPSS questionnaire were modified to obtain responses based on time since the last visit rather than during the last month. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an mIPSS Total Score that ranged from 0 to 35; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the analysis of covariance (ANCOVA) model with treatment, prior alpha-blocker use (yes/no), and country (Japan/Korea) as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 2 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.|||units on a scale||Standard Error|Least Squares Mean
2673639|NCT01460342|Secondary|Clinician Global Impression of Improvement (CGI-I) Scale at 12 Weeks|The CGI-I measured the clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores were 1 (Very much better), 2 (Much improved), 3 (Minimally improved), 4 (No change), 5 (Minimally worse), 6 (Much worse), and 7 (Very much worse).|12 Weeks|Randomized participants who received at least 1 dose of study drug.|||participants|||Number
2673641|NCT01460342|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index|"The IPSS QoL Index assessed the participant's response to the following question, If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?. Response options were 0 (Delighted), 1 (Pleased), 2 (Mostly satisfied), 3 (Mixed, about equally satisfied and dissatisfied), 4 (Mostly dissatisfied), 5 (Unhappy), and 6 (Terrible), for a QoL Index Score that ranged from 0 to 6. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates."|Baseline, 4 weeks, 8 weeks, 12 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.|||units on a scale||Standard Error|Least Squares Mean
2673642|NCT01460342|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore|The IPSS Voiding (Obstructive) Subscore was the sum of Questions 1, 3, 5, and 6 in the IPSS questionnaire. Each question was scored from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms) for an IPSS Voiding (Obstructive) Subscore that ranged from 0 to 20; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 4 weeks, 8 weeks, 12 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.|||units on a scale||Standard Error|Least Squares Mean
2673643|NCT01460342|Secondary|Change From Baseline in the International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore|The IPSS Storage (Irritative) Subscore was the sum of Questions 2, 4, and 7 in the IPSS questionnaire. Each question was scored from 0 (no irritative symptoms) to 5 (frequent irritative symptoms) for an IPSS Storage (Irritative) Subscore that ranged from 0 to 15; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 4 weeks, 8 weeks, 12 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.|||units on a scale||Standard Error|Least Squares Mean
2673644|NCT01460342|Secondary|Change From Baseline in Total Score of International Prostate Symptom Score (IPSS)|The IPSS Total Score was the sum of Questions 1 through 7 in the IPSS questionnaire. Each question was based on the participant's urination experiences and prostate symptoms during the last month. Scores ranged from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score that ranged from 0 to 35; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 4 weeks, 8 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.|||units on a scale||Standard Error|Least Squares Mean
2673645|NCT01460342|Primary|Change From Baseline in Total Score of International Prostate Symptom Score (IPSS) at 12 Weeks|The IPSS Total Score was the sum of Questions 1 through 7 in the IPSS questionnaire. Each question was based on the participant's urination experiences and prostate symptoms during the last month. Scores ranged from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score that ranged from 0 to 35; higher numerical scores represented a greater severity of symptoms. Least squares (LS) mean was based on the mixed-effect model repeated measures (MMRM) model analysis with participants as random effects, treatment, prior alpha-blocker use (yes/no), country (Japan/Korea), visit, and treatment-by-visit interaction as fixed effects, and baseline value and placebo lead-in total IPSS change as fixed covariates.|Baseline, 12 weeks|Randomized participants who received at least 1 dose of study drug and had non-missing data at baseline.|||units on a scale||Standard Error|Least Squares Mean
2673646|NCT01460303|Secondary|Composite Satisfaction Score (CSS)|"The mean scores for the first 5 questions of the Post Operative Questionnaire were used to calculate a Composite Satisfaction Score.~Total Pain (0 none, 10 worst)~Total Catheter Related Pain Range Scale (0 none, 10 worst)~Ease of catheter use (0 easy, 10 difficult)~Feeling of frustration (0 none, 10 very much)~Limited social activities (0 none, 10 very much) All subjects were given and appointment for an outpatient voiding trial after hospital discharge. The Post Operative Questionnaire was completed by the subject one time at that appointment."|5-10 days postoperatively||||units on a scale||Standard Deviation|Mean
2673647|NCT01460303|Primary|Total Catheter Related Pain|Total Catheter Related Pain Range Scale (0 = none, to 10 = worst) on the Post Operative Questionnaire All subjects were given and appointment for an outpatient voiding trial after hospital discharge. The Post Operative questionnaire was completed by the subject one time at that appointment.|5-10 days postoperatively||||units on a scale||Standard Deviation|Median
2673648|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)|"Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.~Recognition Discrimination Index appears in this entry below"|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.|||number of items||Standard Deviation|Mean
2673715|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 2 (week 1)|||||||
2673649|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)|"Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.~Retention scores appear in this entry below."|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.|||percentage of items||Standard Deviation|Mean
2673650|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)|"Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.~Delayed recall scores appear in this entry below."|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.|||correctly recalled items||Standard Deviation|Mean
2673651|NCT01460290|Secondary|Assessment of Motor Control Abnormality as Measured by the Simpson Angus Scale (SAS)|The Simpson-Angus Scale is used to monitor for neurological and musculoskeletal side effects that may be a result of certain psychotropic medications. The scale consists of 10 questions which each can be rated on a scale of 0 to 4. Scores for each item are added to produce a total score. The highest possible total score is 40. Higher scores indicate more adverse outcomes.|Baseline and 12 weeks|ITT and LOCF.|||units on a scale||Standard Deviation|Mean
2673652|NCT01460290|Secondary|Barnes Drug-induced Akathisia Rating Scale (BARS)|This scale is used to measure the presence of akathisia, as may result from use of certain psychotropic medications. The scale contains four items and the score for each item is added to produce the total score. Total scores range from 0 to 14. Higher scores indicate more adverse outcomes.|Baseline and 12 weeks|ITT and LOCF.|||units on a scale||Standard Deviation|Mean
2673653|NCT01460290|Secondary|World Health Organization Disability Assessment Scale (WHO-DAS)|The WHO-DAS II is used to assess patients for difficulties that they experience due to health conditions. Six subscales are represented which cover the following domains: Getting Around (range 1-10), Self Care (range 1-10), Life Activities (range 1-20), Understand/Communicate (range 1-10), Participation in Society (range 1-10), and Getting Along with People (range 1-10). Lower scores represent more positive outcomes, while higher scores represent worse outcomes. Total summary scores were not computed for our analyses and is optional for the measure.|12 weeks|ITT and LOCF.|||units on a scale||Standard Deviation|Mean
2673654|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Dementia Rating Scale (DRS)|The DRS contains items that evaluate cognitive function across 5 subscales: attention, initiation/perseveration, construction, conceptualization, and memory. Subscale raw score ranges are: attention (0-37), initiation/perseveration (0-37), construction (0-6), conceptualization (0-39), and memory (0-25). Raw subscale scores are added for a total raw score with range 0-144. For each raw subscale score, scaled scores are looked up from a battery of 13 tables. Age of the participant determines which table is to be used. Total raw subscale score also has its own scaled score in the tables. In addition to use in determining scaled scores for each of the subscales, these tables are used to look up the scaled score for the total raw score. The tables are contained in the article Robust and Expanded Norms for the Dementia Rating Scale (Pedraza, Lucas, et al. 2010); Archives of Clinical Neuropsychology 25; 347-358. Higher scores, raw and scaled, indicate better cognitive functioning.|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.|||units on a scale||Standard Deviation|Mean
2673655|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT)|"Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-36). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.~Total recall scores appear in this entry below."|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.|||correctly recalled items||Standard Deviation|Mean
2673656|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Trail Making Test|The Trails test is a measure of cognitive functioning. The measure consists of two parts: A and B. In part A, participants are asked to draw a trail connecting a series of numbers in sequential order. In Part B, participants are asked to draw a trail connecting a combination of letters and numbers. The time taken to complete each task is noted as the score (e.g., 78 seconds). For Trails A, there is no upper limit on the score, as subjects are given as much time as is needed for them to complete the task. Higher scores indicate poorer cognitive functioning. In Trails B, the task is timed with an upper limit of five minutes. If, at four minutes, it is determined that the subject will not likely complete the task in the time allotted, then the task can be called off. Higher scores indicate poorer cognitive functioning.|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.|||seconds||Standard Deviation|Mean
2673657|NCT01460290|Secondary|Change in Cognitive Status as Measured by the Stroop Task|The Stroop evaluates patients for cognitive functioning. Patients are to read words aloud or name colors as quickly as possible in a 45-second period. The measure contains three tasks, each associated with a subscale as follows: Word, Color, and Color-Word. Each subscale contains 100 items. The raw score range for each of the subscales is 0-100. Each raw subscale score is converted to a T-Score. The possible T-Score range for the Word subscale is 15 to 85. The possible T-Score range for the Color subscale is 8 to 92. The possible T-Score range for the Color-Word subscale is 3 to 98. Higher scores on the subscales indicate better cognitive functioning. Subscales are scored independently and are not added to produce a total score.|Baseline and 12 weeks|Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.|||T-Score||Standard Deviation|Mean
2673658|NCT01460290|Secondary|Change in Bipolar Disorder Symptoms as Measured by the Brief Psychiatric Rating Scale (BPRS)|The minimum possible score is 18 and the maximum score is 126. A higher score implies a worse condition.|Baseline and 12 weeks|ITT and LOCF.|||units on a scale||Standard Deviation|Mean
2673659|NCT01460290|Secondary|Change in Depressive Symptoms as Measured by the Montgomery Asberg Depression Rating Scale (MADRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|Baseline and 12 weeks|Participants with a baseline MADRS score of 16 or greater were analyzed. LOCF|||units on a scale||Standard Deviation|Mean
2673660|NCT01460290|Secondary|Change in Perception of Mental Health as Measured by the Short Form General Health Survey (SF-12)|The minimum possible score is 1 and the maximum score is 99. A higher score implies a better perceived condition.|Baseline and 12 weeks|ITT and LOCF.|||units on a scale||Standard Deviation|Mean
2673661|NCT01460290|Secondary|Change in Perception of Physical Health as Measured by the Short Form General Health Survey (SF-12)|The minimum possible score is 1 and the maximum score is 99. A higher score implies a better perceived condition.|Baseline and 12 weeks|ITT and LOCF.|||units on a scale||Standard Deviation|Mean
2673662|NCT01460290|Secondary|Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP)|"The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.~The CGI-BP has three scores - Mania Severity, Depression Severity, and Overall Bipolar Illness Severity."|Baseline and 12 weeks|Intention To Treat (ITT) and LOCF|||units on a scale||Standard Deviation|Mean
2673663|NCT01460290|Primary|Change in Manic Symptoms as Measured by the Young Mania Rating Scale (YMRS)|The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.|Baseline and 12 weeks|Participants with a baseline YMRS score of 12 or greater were analyzed. LOCF|||units on a scale||Standard Deviation|Mean
2673664|NCT01460290|Primary|Change in Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D)|The minimum possible score is 0 and the maximum score is 52. A higher score implies a worse condition.|Baseline and 12 weeks|Participants with baseline HAM-D score of 8 or greater were analyzed. Last Observational Carried Forward (LOCF).|||units on a scale||Standard Deviation|Mean
2673665|NCT01460225|Primary|Gastric Emptying|gastric emptying was measured before and after 7 days of treatment.at set times (2 and 4 hours post eating a radio-labeled meal)|Day 1 and Day 7||||percent meal retention||Standard Deviation|Mean
2673666|NCT01460160|Secondary|Number of Participants With Grade 3-4 Serum Chemistry Abnormalities|The number of participants with grade 3-4 serum chemistry laboratory abnormalities was presented for each arm.|Approximately 3 years|All treated participants|||participants|||Number
2673667|NCT01460160|Secondary|Number of Participants With Grade 3-4 Kidney Function Abnormalities|The number of participants experiencing Grade 3 or 4 kidney function laboratory abnormalities was reported by arm.|Approximately 3 years|All treated participants|||participants|||Number
2673668|NCT01460160|Secondary|Number of Participants With Grade 3-4 Liver Function Laboratory Abnormalities.|The number of participants experiencing Grade 3 or 4 liver function laboratory abnormalities was reported by arm.|Approximately 3 years|All treated participants|||participants|||Number
2673669|NCT01460160|Secondary|Number of Participants With Grade 3-4 Hematology Laboratory Abnormalities.|The number of participants experiencing Grade 3 or 4 hematology laboratory abnormalities was reported by arm.|Approximately 3 years|All treated participants|||participants|||Number
2673670|NCT01460160|Secondary|Number of Participants With BCR-ABL Mutations at Time of Disease Progression|The number of Ph+ ALL participants with BCR-ABL Mutations at Disease Progression or Relapse was reported for each arm.|Approximately 3 years|Treated Ph+ ALL participants with mutation data at both baseline and disease progression|||participants|||Number
2673671|NCT01460160|Secondary|Number of Participants With AEs or Drug Related Death|The number of participants with any AE or with study drug-related death was reported for each arm.|Approximately 3 years|All treated participants|||Participants|||Number
2673672|NCT01460160|Secondary|Percentage of Participants With Minimal Residual Disease Based on Ig/TCR Method|The number of participants with MRD at the end of the Induction 1B and Consolidation periods was divided by the number of treated participants and expressed as a percentage.|3 years|All treated participants|||Percentage of Participants||95% Confidence Interval|Number
2673673|NCT01460160|Secondary|Complete Remission Rate|CR rate is defined as the proportion of participants achieving a complete remission, i.e. < 5% lymphoblasts in bone marrow and in CSF, with no evidence of other extramedullary disease, and expressed as a percentage. Complete remission will be assessed at the end of Induction IA, end of induction IB and end of the consolidation period for all treated participants.|3 years|All treated participants|||Percentage of Partcipants|||Number
2673674|NCT01460160|Secondary|Overall Survival (K-M Estimate) Rate at 3 Years|Overall survival is defined as time from the first day of dasatinib treatment until the time of death. Participants who have not died or who are lost to follow-up will be censored on the last date the participant is known to be alive. The rate of OS at 3 years was expressed as a percentage of all treated participants.|3 years|All treated participants|||Percentage of Participants||95% Confidence Interval|Number
2673716|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 10 (week 5)|||||||
2673756|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|12 week follow up|||||||
2673675|NCT01460160|Secondary|Percentage of Participants With 3-year EFS Rate (K-M Estimate)|Overall estimation of the EFS of dasatinib plus chemotherapy was performed utilizing the Kaplan-Meier (KM) Product Limit method. The 3-year EFS rates were computed with the corresponding 95% CI's using Greenwood's formula. Analyses of EFS included KM plots with number of patients at risk. Participants who neither relapse nor die or who are lost to follow-up were censored on the date of their last bone marrow, CSF assessment or physical exam, whichever occurred last.|3 years|All treated participants|||Percentage of Participants||95% Confidence Interval|Number
2673676|NCT01460160|Primary|Percentage of Participants With 3-year Event-free Survival (EFS)|"EFS is defined as the time from the starting date of dasatinib until an event. In the primary analysis, the 3-year EFS response rate is defined as the number of participants without event after 3 years since the start of dasatinib divided by the number of treated participants and expressed as a percentage. Events for EFS are defined as ANY first one of the following:~Lack of complete response in bone marrow~Relapse at any site~Development of second malignant neoplasm~Death from any cause"|3 years|All treated participants|||Percentage of Participants||90% Confidence Interval|Number
2673677|NCT01459913|Secondary|Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)|"AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Study drug includes all investigational agents administered during the course of the study."|Baseline up to Week 48|Safety set included all subjects who received at least 1 dose of study drug.|||participants|||Number
2673678|NCT01459913|Secondary|Number of Subjects With Extended Rapid Viral Response (eRVR)|"The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups."|Week 4 and Week 12|FA Set.|||participants|||Number
2673679|NCT01459913|Secondary|Number of Subjects With Rapid Viral Response (RVR)|"The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups."|Week 4|FA Set.|||participants|||Number
2673680|NCT01459913|Secondary|Percentage of Subjects With On-Treatment Virologic Failure|On-treatment virologic failure was defined as subjects who met futility (as per investigator discretion) or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). This outcome was planned to be assessed in all reporting groups and results were to be reported for total arm as well.|Baseline up to Week 48|FA Set.|||percentage of participants|||Number
2673681|NCT01459913|Secondary|Percentage of Subjects With Viral Relapse|"Viral relapse was defined as having detectable HCV RNA during antiviral follow-up in subjects who had HCV RNA less than (<) lower limit of quantification (LLOQ) at end of treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The LLOQ was 25 IU/mL and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups."|After last dose of study drug up to 4 weeks (up to Week 28), 12 weeks (up to Week 36), 24 weeks (up to Week 48) antiviral follow-up|FA Set.|||percentage of participants|||Number
2673682|NCT01459913|Secondary|Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72)|"SVR72 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 72. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups."|Week 72|FA Set. Here number of subjects analyzed = subjects who were evaluable for this measure. Subjects who did not have the SVR72 assessment because they discontinued the study due to ‘Study Terminated by the Sponsor’ are excluded from this analysis.|||percentage of participants|||Number
2673683|NCT01459913|Secondary|Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)|"SVR24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups."|24 weeks after last planned dose of study drug (up to Week 48)|FA Set.|||percentage of participants|||Number
2673684|NCT01459913|Secondary|Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)|"SVR4 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 4 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups."|4 weeks after last planned dose of study drug (up to Week 28)|FA Set.|||percentage of participants|||Number
2673717|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 9 (week 5)|||||||
2673685|NCT01459913|Primary|Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)|"SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) and Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) reporting groups."|12 weeks after last planned dose of study drug (up to Week 36)|Full Analysis (FA) Set.|||percentage of participants|||Number
2673686|NCT01459796|Secondary|Percentage of Participants With Rescue Medication From Day 1 to Day 364 (Week 52)|Participants who required rescue medication after having 2 or more gout flares during the treatment period were evaluated.|Day 1 to Day 364 (Week 52)|Safety analysis set (SAF) that included all randomized participants who received any study medication and was based on the treatment received (as treated).|||percentage of participants|||Number
2673687|NCT01459796|Secondary|Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 364 (Week 52)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares at Week 52 was to be reported for this outcome measure.|Day 1 to Day 364 (Week 52)|As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.||||||
2673688|NCT01459796|Secondary|Percentage of Participants With at Least One Gout Flare From Day 1 to Day 364 (Week 52)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare at Week 52 was to be reported for this outcome measure.|Day 1 to Day 364 (Week 52)|As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.||||||
2673689|NCT01459796|Secondary|Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 168 (Week 24)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares at Week 24 was to be reported for this outcome measure.|Day 1 to Day 168 (Week 24)|As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.||||||
2673690|NCT01459796|Secondary|Percentage of Participants With at Least One Gout Flare From Day 1 to Day 168 (Week 24)|Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare at Week 24 was to be reported for this outcome measure.|Day 1 to Day 168 (Week 24)|As per sponsor's discretion, the study was discontinued due to which data for this outcome measure was not collected and hence, not analyzed and reported.||||||
2673691|NCT01459796|Primary|Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)|Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.|Day 1 to Day 392 (Week 56)|Safety analysis set (SAF) that included all randomized participants who received any study medication and was based on the treatment received (as treated).|||percentage of participants|||Number
2673692|NCT01459783|Secondary|Change in Process Measures of Dementia Care Quality at 6 and 12 Months|The investigators will collect caregiver survey identified care process measures to assess which medical care processes that are specific to dementia occurred as a potential mediator of change in outcomes.|0, 6 and 12 months|||||||
2673693|NCT01459783|Secondary|Change in Care Recipient Quality of Life at 6 and 12 Months|The investigators will evaluate patient health-related quality of life (HRQOL) by proxy (caregiver) assessment using the 15-item Health Utilities Index (HUI2), a generic health state classification system with preference-based utility weights derived from the general population. The HUI is one of the more widely used utility measures and has been used in previous studies of elderly with dementia and their caregivers.|0, 6 and 12 months|||||||
2673694|NCT01459783|Secondary|Change in Caregiver Quality of Life at 6 and 12 Months|The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia, incorporates non-health related issues as well as positive aspects of caregiving, and has demonstrated feasibility as a phone-based instrument in both English and Spanish. Eighty items are distributed across 10 scales: assistance with ADLs, assistance with IADLs, personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving.|0, 6 and 12 months|||||||
2673695|NCT01459783|Secondary|Change in Caregiver Depression at 6 and 12 Months|"The Patient Health Questionnaire - Nine (PHQ-9) is a 9-item self-report measure of depressive symptoms over the previous 2 weeks. The PHQ-9 is the depression module of the PRIME- MD diagnostic instrument for common mental disorders. It covers each of the 9 DSM-IV depression criteria scoring them as 0 (not at all) to 3 (nearly every day)."|0, 6 and 12 months|||||||
2673696|NCT01459783|Primary|Change in Care Recipient Memory and Problem Behaviors at 6 and 12 Months|The Revised Memory and Behavior Problem Checklist (RMBPC) was developed by Teri and colleagues. The RMBPC instrument assess 24 care receiver problems in the areas of behavior, memory, and depression and whether each behavior had occurred in the prior week. Higher RMBPC scores mean worse memory/behavior problems. The minimum possible score for number of problems is zero, and the maximum score for number of problems is 24.|0, 6 and 12 months||||units on a scale||Standard Deviation|Mean
2673697|NCT01459783|Primary|Change in Caregiver Burden at 6 and 12 Months|The Zarit Burden Interview (BI) is a widely used validated measure to assess stressors experienced by caregivers of persons with dementia. Originally a 29-item instrument, the 22-item modified version is easily completed by telephone. This instrument covers five constructs of burden: health, psychological well-being, finances, social life, and relationship with impaired person and an overall summary score of caregiver burden. Higher Zarit scores indicate greater caregiver burden. The minimum possible score is 0, and the maximum possible score is 110.|0, 6 and 12 months||||units on a scale||Standard Deviation|Mean
2673698|NCT01459718|Secondary|Left Ventricular Ejection Fraction (LVEF)|LVEF % was measured by cardiac magnetic resonance (CMR).|6, 12, 18, 24 months|The full analysis set included all the participants entered in the study with at least a valid post-baseline assessment of the primary efficacy variable. Here 'n' number analyzed signifies number of participants evaluable at each time point.|||Percentage of ejection fraction||Standard Deviation|Mean
2673699|NCT01459718|Secondary|Correlation Between Change From Baseline in Serum Ferritin and LIC Levels|Spearman correlation coefficients between serum ferritin and LIC changes from baseline levels were reported.|Baseline, 6, 12, 18, 24 months|Full analysis set included all participants entered in study with at least a valid post-baseline assessment of the primary efficacy variable. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable at each time point.|||Spearman correlation coefficient|||Number
2673700|NCT01459718|Secondary|Change From Baseline in Liver Iron Concentration (LIC)|Change from baseline in LIC was determined by change in liver MRI T2*.|Baseline, 6, 12, 18, 24 months|The full analysis set included all the participants entered in the study with at least a valid post-baseline assessment of the primary efficacy variable. Here 'n' number analyzed signifies number of participants evaluable at each time point.|||mg of iron/gram of dry weight of liver||Standard Deviation|Mean
2673701|NCT01459718|Secondary|Time to Response|Time to response was defined as the time from baseline when the participant had severe cardiac iron overload to the time when the participant achieved mild/moderate cardiac overload (T2*>10 milliseconds [ms]).|24 months|The full analysis set included all participants entered in the study with at least a valid post-baseline assessment of the primary efficacy variable. Here 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure at the specified time-point.|||ms||Standard Deviation|Mean
2673702|NCT01459718|Secondary|Change From Baseline in Cardiac Iron Overload of Patients in Intensive Iron Chelation Therapy Consisting of Deferasirox-DFO and After Transition to Deferasirox Monotherapy|Cardiac iron overload was determined by cardiac MRI T2*. Cardiac iron overload also was measured by the monthly velocity of heart MRI T2*.|Baseline, 6, 12, 18, 24 months|The full analysis set included all the participants entered in the study with at least a valid post-baseline assessment of the primary efficacy variable. Here 'n' number analyzed signifies number of participants evaluable at each time point.|||Milliseconds (ms)||Standard Deviation|Mean
2673703|NCT01459718|Primary|Number of Patients With Stable Disease (SD)|Stable Disease is defined as those patients that never achieved an improvement in the cardiac MRI T2* to values >10ms during the 24 months of study.|24 months|The full analysis set included all the participants entered in the study with at least a valid post-baseline assessment of the primary efficacy variable.|||Participants|||Count of Participants
2673704|NCT01459718|Primary|Number of Patients Achieving a Partial Response (PR)|Partial Response is defined as patients that stop intensive deferasirox -DFO treatment at any time point during the 24 months study and transition to receive deferasirox monotherapy, but due to a deterioration in cardiac MRI T2* to a value < 10 ms revert back to intensive deferasirox -DFO iron chelation therapy during the 24 months of study.|24 months|The full analysis set included all the participants entered in the study with at least a valid post-baseline assessment of the primary efficacy variable.|||Participants|||Count of Participants
2673705|NCT01459718|Primary|Number of Patients Achieving a Complete Response (CR)|Complete Response is defined as patients that stop intensive deferasirox -DFO treatment, at any time point during the 24 months of study, based on an improvement in the cardiac Magnetic Resonance Imaging T2 star technique (MRI T2*) value being >10ms, and continue to be treated with deferasirox monotherapy without any further need for reverting back to intensive iron chelation treatment during the 24 months of study.|24 months|The full analysis set included all the participants entered in the study with at least a valid post-baseline assessment of the primary efficacy variable.|||Participants|||Count of Participants
2673706|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|2.5 weeks (or after treatment session 5)|||||||
2673707|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 10 (week 5)|||||||
2673708|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 9 (week 5)|||||||
2673709|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 8 (week 4)|||||||
2673710|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 7 (week 4)|||||||
2673711|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 6 (week 3)|||||||
2673712|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 5 (week 2.5)|||||||
2673713|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 4 (week 2)|||||||
2673714|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 3 (week 2)|||||||
2673719|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 7 (week 4)|||||||
2673720|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 6 (week 3)|||||||
2673721|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 5 (week 2.5)|||||||
2673722|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 4 (week 2)|||||||
2673723|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 3 (week 2)|||||||
2673724|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 2 (week 1)|||||||
2673725|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 10 (week 5)|||||||
2673726|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 9 (week 5)|||||||
2673727|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 8 (week 4)|||||||
2673728|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 7 (week 4)|||||||
2673729|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 6 (week 3)|||||||
2673730|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 5 (week 2.5)|||||||
2673731|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 4 (week 2)|||||||
2673732|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 3 (week 2)|||||||
2673733|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 2 (week 1)|||||||
2673734|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|26 week follow up|||||||
2673735|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|12 week follow up|||||||
2673736|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|2.5 weeks (or after treatment session 5)|||||||
2673737|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|5 weeks (or after treatment session 10)|||||||
2673738|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 10 (week 5)|||||||
2673739|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 9 (week 5)|||||||
2673740|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 8 (week 4)|||||||
2673741|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 7 (week 4)|||||||
2673742|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 6 (week 3)|||||||
2673743|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 5 (week 2.5)|||||||
2673744|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 4 (week 2)|||||||
2673745|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 3 (week 2)|||||||
2673759|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|26 Week follow up|||||||
2673760|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|12 Week follow up|||||||
2673761|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|5 weeks (or after treatment session 10)|||||||
2673762|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|2.5 weeks (or after treatment session 5)|||||||
2673763|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|26 Week follow up|||||||
2673764|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|12 Week follow up|||||||
2673765|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|5 weeks (or after treatment session 10)|||||||
2673766|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|2.5 weeks (or after treatment session 5)|||||||
2673767|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|26 Week follow up|||||||
2673768|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|12 Week follow up|||||||
2673769|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|5 weeks (or after treatment session 10)|||||||
2673770|NCT01459705|Secondary|PTSD Checklist (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|26 week follow up|||||||
2673771|NCT01459705|Secondary|PTSD Checklist (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|12 week follow up|||||||
2673772|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|2.5 weeks (or after treatment session 5)|||||||
2673773|NCT01459705|Secondary|PTSD Checklist (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|5 weeks (or after treatment session 10)|||||||
2673774|NCT01459705|Secondary|PTSD Checklist (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|2.5 weeks (or after treatment session 5)|||||||
2673775|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Treatment session 1 (week 1)|||||||
2673776|NCT01459705|Secondary|BASIS-24|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Treatment session 1 (week 1)|||||||
2673777|NCT01459705|Secondary|Side Effects Questionnaire|The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.|Treatment session 1(week 1)|||||||
2673778|NCT01459705|Secondary|Subjective Units of Distress (SUDs)|Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.|Treatment session 1 (week 1)|||||||
2673779|NCT01459705|Secondary|Intent to Attend|This is a measure to assess the intent to complete study procedures.|Screening Visit (Day 1)|||||||
2673780|NCT01459705|Secondary|Behavior and Sympton Identification Scale (BASIS-24)|To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.|Screening Visit(Day 1)|||||||
2673781|NCT01459705|Secondary|Beck Anxiety Inventory (BAI)|The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.|Screening Visit(Day 1)|||||||
2673782|NCT01459705|Secondary|Suicide Risk Assessment|Due to the nature of the questions, this is deemed to be of safety nature.|Screening Visit(Day 1)|||||||
2673783|NCT01459705|Secondary|Perceived Stigma Measure (PSS)|Stigma will be measured using a 5 question assessment scale.|Screening Visit(Day 1)|||||||
2673784|NCT01459705|Secondary|Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)|The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.|Screening Visit(Day 1)|||||||
2673785|NCT01459705|Secondary|Beck Depression Inventory-II (BDI-II)|This self report measure of depression contains 21 items that are rated on a 4 point scale.|Screening Visit(Day 1)|||||||
2673786|NCT01459705|Secondary|Primary Care PTSD Screen (PC-PTSD)|The PC-PTSD is a four-item measure designed to screen for PTSD.|Screening Visit (Day 1)|||||||
2673787|NCT01459705|Secondary|PTSD Checklist- Civilian (PCL-C)|The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.|Screening Visit (Day 1)|||||||
2673788|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|26 Week follow up||||units on a scale||Standard Deviation|Mean
2673789|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|12 week follow up||||units on a scale||Standard Deviation|Mean
2673790|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|5 weeks (or after treatment session 10)|Participants who provided outcome data at post treatment|||units on a scale||Standard Deviation|Mean
2673791|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|2.5 weeks (or after treatment session 5)|Participants who provided data at mid treatment|||units on a scale||Standard Deviation|Mean
2673792|NCT01459705|Primary|Clinician-Administered PTSD Scale (CAPS)|The CAPS is a structured interview that assesses all Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) PTSD criteria in terms of frequency and intensity. We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.|Screening Visit (Day 1)|Baseline scores on the CAPS-W (last week reference)|||units on scale||Standard Deviation|Mean
2673793|NCT01459653|Secondary|Patient-level Predictor for Cancer-related Mortality|"Objective 10: To model patient- and center-level variables between patients who died vs. survived during the course of primary or secondary prophylaxis with EP2006 in all patients and those with break-through FN episodes.~Table presents patient level predictors for cancer-related mortality: female gender, poor performance (ECOG >=2) during study.~ECOG score is a severity scale from 0 to 5 (highest) to grade toxicity and is defined as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=lethal. ECOG is described in more detail by Oken et al, Am J Clin Oncol (CCT) 5:649-655, 1982."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with data|||participants|||Number
2673794|NCT01459653|Primary|Incidence of Outcomes|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of different outcomes and composite outcome by chemotherapy risk group. ^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance.~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample|||percentage of participants|||Number
2673795|NCT01459653|Primary|EP2006 Cycles by Treatment Duration|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|All cycles from patients in the evaluable sample with study drug duration|||cycles|Participants||Number
2673796|NCT01459653|Primary|EP2006 Day of Initiation: Cycle Distribution|"Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.~Table presents number of cycles by day after chemotherapy."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles of patients in evaluable sample with day of study drug initiation|||cycles|Participants||Number
2673797|NCT01459653|Secondary|Patient-level Predictors for All-cause Mortality|"Objective 10: To model patient- and center-level variables between patients who died vs. survived during the course of primary or secondary prophylaxis with EP2006, in all patients and those with break-through FN episodes.~Table presents patient-level predictors for all-cause mortality: history of anemia at enrollment, liver/renal/cardiac comorbidity, poor performance (ECOG >=2) during study"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with data|||participants|||Number
2673798|NCT01459653|Secondary|Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Patient Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; ECOG: Eastern Cooperative Oncology Group; FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score. H/o repeated infections refers at enrollment; H/o: History of"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Patients in evaluable sample with composite outcome data|||participants|||Number
2673799|NCT01459653|Secondary|Modeling Composite Outcome (Any of CIN Grade 4, FN, CIN/FN-related Hospitalization, CIN/FN-related Chemotherapy Disturbance): Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; ECOG: Eastern Cooperative Oncology Group; FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles of patients from evaluable sample with composite outcome data|||cycles|Participants||Number
2673800|NCT01459653|Secondary|Modeling CIN/FN-related Chemotherapy Disturbance: Patient Level (Patient-level Predictors)|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with CIN/FN-related chemotherapy disturbance data|||cycles|||Number
2673801|NCT01459653|Secondary|Modeling CIN/FN-related Chemotherapy Disturbance: Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score; Chemotherapy disturbance=dose reduction, delay, and/or cancellation"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles of patients in evaluable sample with CIN/FN-related chemotherapy disturbance with data|||cycles|Participants||Number
2673802|NCT01459653|Secondary|Modeling CIN/FN-related Hospitalization: Patient Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with CIN/FN-related hospitalization data|||participants|||Number
2673803|NCT01459653|Secondary|Modeling CIN/FN-related Hospitalization: Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles of patients in evaluable sample with CIN/FN-related hospitalization data|||cycles|Participants||Number
2673804|NCT01459653|Secondary|Modeling FN Episode: Patient Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with FN episode data|||participants|||Number
2673812|NCT01459653|Primary|Patient/Center-level Covariance Parameter Estimates of Absolute Neutrophil Count|"Objective 6: To examine the multilevel determinants (patient, center) of hematological outcomes of primary and secondary prophylaxis with EP2006 to better understand the variability in outcomes achieved.~Mean and standard error estimated from ANCOVA"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample|||participants|Participants||Number
2674991|NCT01451398|Secondary|Time to Rescue|Time from Week 0 (baseline) to initiation of rescue therapy (up to a maximum of 24 weeks/end of treatment) for subjects not responding to treatment|Baseline to Week 24|Full analysis set|||Days||Full Range|Median
2673805|NCT01459653|Secondary|Modeling FN Episode: Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006.~Only results with a p-value of <0.05 are shown in the statistical appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles of patients in evaluable sample with FN episode data|||cycles|Participants||Number
2673806|NCT01459653|Secondary|Modeling Grade 4 CIN Episode: Patient Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006~Only results with a p-value of <0.05 are shown in the statistical appendices.~H/o=History of; CI=confidence interval; CIN=chemotherapy-induced neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with data|||participants|||Number
2673807|NCT01459653|Secondary|Modeling Grade 4 CIN Episode: Cycle Level|"Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006.~Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006~Only results with a p-value of <0.05 are added as statistical analyses appendices.~CI: confidence interval; CIN: chemotherapy-induced neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles in evaluable sample with any grade 4 CIN data|||cycles|Participants||Number
2673808|NCT01459653|Secondary|Characteristics of Clusters: Liver, Renal and/or Cardiovascular Disease|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.~FN=Febrile Neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.~Only patients with data in each group are analyzed for liver, renal and/or cardiovascular disease."|||participants|||Number
2673809|NCT01459653|Secondary|Characteristics of Clusters: History of Antibiotic Use for CIN|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.~CIN=Chemotherapy Induced Neutropenia; FN=Febrile Neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.~Only patients with data in each group are analyzed for history of antibiotic use for CIN."|||participants|||Number
2673810|NCT01459653|Secondary|Characteristics of Clusters: Cancer Stage|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.~FN=Febrile Neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.~Only patients with data in each group are analyzed for cancer stage."|||participants|||Number
2673811|NCT01459653|Secondary|Characteristics of Clusters: ECOG Performance Status|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.~ECOG score is a severity scale from 0 to 5 (highest) to grade toxicity and is defined as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=lethal. ECOG is described in more detail by Oken et al, Am J Clin Oncol (CCT) 5:649-655, 1982.~FN=Febrile Neutropenia; ECOG: European Cooperative Oncology Group"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.~Only patients with data in each group are analyzed for ECOG performance status."|||Scores on a scale||Standard Deviation|Mean
2674992|NCT01451398|Secondary|Proportion of Subjects Requiring Rescue Therapy||Baseline to Week 24|Full analysis set|||percentage of participants|||Number
2673813|NCT01459653|Primary|Predictors of Absolute Neutrophil Count|"Objective 6: To examine the multilevel determinants (patient, center) of hematological outcomes of primary and secondary prophylaxis with EP2006 to better understand the variability in outcomes achieved.~Hierarchical modeling was used to test the relationship of patient- and physician/center-level variables and treatment response in terms of ANC. This analysis was conducted at the cycle level using a 1-cycle lag between treatment patterns and outcomes, that is study drug treatment patterns in one cycle predicted the ANC value at the beginning of the next cycle. Log-transformed ANC values were used.~Table presents predictors for ANC: GCSF decision, study drug dose, tumor type, patient gender, ECOG, Hb~Since log-transformed Absolute Neutrophil Count (ANC) values were used, Exp(beta) can be interpreted in terms of % change in ANC for each unit change in predictor or for each category relative to the referent (for categorical variables); Hb=Hemoglobin"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles for patients in evaluable sample with data|||participants|Participants||Number
2673814|NCT01459653|Primary|Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Treatment Decision|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents number of patients with any CIN/FN-related chemotherapy disturbances by treatment decision.~CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by treatment decision with data|||participants|||Number
2673815|NCT01459653|Primary|Number of Participants With Any CIN/FN-related Chemotherapy Disturbance by Prophylaxis Type|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents number of patients with any CIN/FN-related chemotherapy disturbance by prophylaxis type.~CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by prophylaxis type|||participants|||Number
2673816|NCT01459653|Primary|Number of Participants With Cancer-related Mortality by Any CIN/FN-related Chemotherapy Disturbance|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents number of patients who had a cancer-related death by any/no CIN/FN-related chemotherapy disturbance~CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by any/no CIN/FN-related chemotherapy disturbance with data|||participants|||Number
2673817|NCT01459653|Primary|Number of Participants With Cancer-related Mortality by Any/no Grade 4 CIN or FN|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents number of patients that had a cancer-related death by any/no grade 4 CIN or FN~CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by any/no grade 4 CIN or FN with data|||participants|||Number
2673818|NCT01459653|Primary|Number of Participants With All-cause Mortality by CIN/FN-related Chemotherapy Disturbance|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table shows number of patients who died by any or no CIN/FN related chemotherapy disturbance.~CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by any or no CIN/FN related chemotherapy disturbance.|||participants|||Number
2673819|NCT01459653|Primary|Number of Participants With All-cause Mortality by Any/no Grade 4 CIN and/or FN|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table shows number of patients that died in each group.~CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by any/no grade 4 CIN/FN|||participants|||Number
2673848|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 6|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 6. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 6|||days|Participants|Standard Deviation|Mean
2673820|NCT01459653|Primary|Number of Patients by Cause of Death|Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Safety population, i.e. all patients who received at least one dose of study drug|||participants|||Number
2673821|NCT01459653|Primary|Incidence of Outcomes by Study Drug Duration: Cycle Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of outcomes on a cycle level by study drug duration. ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia;"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by study drug duration. As these are cycle-level analyses and since patients can be in more than one category over the course of the study, the sum of patients of all three categories may exceed the sample size.|||percentage of participants|||Number
2673822|NCT01459653|Primary|Incidence of Outcomes by Day of Study Drug Initiation: Cycle Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of outcomes on a cycle level by day of study drug initiation. ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010). *Day of EP2006 initiation- Day 0 (during chemotherapy); **Day of EP2006 initiation- Days 1-3 (per guidelines)"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by day of study drug initiation. As these are cycle-level analyses and since patients can be in more than one category over the course of the study, the sum of patients of all three categories may exceed the sample size.|||percentage of participants|||Number
2673823|NCT01459653|Primary|Incidence of Outcomes: Cycles Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of outcomes on a cycle level. ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||Percentage of participants|||Number
2673824|NCT01459653|Primary|Incidence of Outcomes by Mean GIS: Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of outcomes by day (mean GIS over all visits). ^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by mean GIS|||percentage of participants|||Number
2673825|NCT01459653|Primary|Incidence of CIN Grade 4 Episodes by EP2006 Dose: Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by study drug dose|||percentage of participants|||Number
2673849|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 5|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 5. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 5|||days|Participants|Standard Deviation|Mean
2674181|NCT01457846|Primary|Median Progression Free Survival|PFS is the time from randomisation until the date of objective disease progression as defined by Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) or death (by any cause in the absence of progression).|Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week)|Full analysis set|||months|||Number
2673826|NCT01459653|Primary|Incidence of CIN/FN-related Hospitalization Outcomes by EP2006 Practice Patterns (Relative to Guidelines): Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of different outcomes and composite outcome by prophylaxis decision (relative to guidelines). ^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance.~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by prophylaxis decision (relative to guidelines)|||percentage of participants|||Number
2673827|NCT01459653|Primary|Incidence of CIN/FN-related Chemotherapy Disturbance by EP2006 Prophylaxis Type: Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by prophylaxis type|||Percentage of participants|||Number
2673828|NCT01459653|Primary|Incidence of Outcomes by Chemotherapy Risk: Patient Level|"Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment.~Table presents incidences of different outcomes and composite outcome by chemotherapy risk group. ^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance.~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010)."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by chemotherapy risk|||percentage of participants|||Number
2673829|NCT01459653|Primary|CIN/FN Episodes: Cycle Level|"Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.~Chemotherapy-Induced Neutropenia (CIN); Febrile Neutropenia (FN); Chemotherapy disturbance=dose reduction, delay, and/or cancellation; Composite (any of CIN grade 4, FN, CIN/FN-related hospitalization [RH] or CIN/FN-related chemotherapy disturbance [RCD])"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles in evaluable sample|||cycles|Participants||Number
2673830|NCT01459653|Primary|Number of Patients With CIN/FN Episodes: Patient Level|"Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.~CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; Chemotherapy disturbance=dose reduction, delay, and/or cancellation; Composite (any of CIN grade 4, FN, CIN/FN-related hospitalization or CIN/FN-related chemotherapy disturbance)~A patient may fall into more than one or none of the categories displayed."|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||participants|||Number
2673831|NCT01459653|Primary|Absolute Neutrophil Count (ANC) Across All Cycles|Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||Per mm^3|Participants|Standard Deviation|Mean
2673832|NCT01459653|Primary|Absolute Neutrophil Count (ANC) at EP2006 Initiation|Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN.|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of patients in evaluable sample with initial ANC result|||Per mm^3||Standard Deviation|Mean
2673833|NCT01459653|Primary|GCSF Congruence Score (GCS)|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~The GCS is computed at the patient level as an overall grade of how congruent actual GCSF treatment is to recommended treatment. The GCS is computed as follows and scores range from 0 to 3: GCS = Σ(CRS + mean GIS over all cycles + GPS), with higher scores indicating higher congruence.~CRS: Chemotherapy Risk Score (0 or 1 with 1 best); FN: febrile neutropenia; GCSF: granulocyte colony-stimulating factor; GIS=GCSF Initiation Score (0 to 1 with 1 best); GPS=GCSF persistence score (0 to 1 with 1 best);"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample with GCSF congruence score by tumor type|||scores on a scale||Standard Deviation|Mean
2673834|NCT01459653|Primary|GCSF Persistence Score (GPS)|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~The GPS grades persistence based on the number of cycles in the line of chemotherapy in which EP2006 was administered, D, relative to the number of cycles in which it should have been continued, C. Thus, the GPS = D/C and ranges from 0 to 1.0~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; EORTC=European Organization for Research and Treatment in Cancer; FN=Febrile Neutropenia; GCSF=Granulocyte Colony-Stimulating Factor"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Patients in the evaluable sample with a GCSF persistence score (GPS).|||participants|||Number
2673835|NCT01459653|Primary|GCSF Initiation Score (GIS)|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~ANC=Absolute Neutrophil Count; GIS Score 0 (EP2006 initiated on day 0 of chemotherapy or on day 10 or later); GIS Score 0.50 (EP2006 initiated on days 7-9 of chemotherapy); GIS Score 0.75 (EP2006 initiated on days 4-6 of chemotherapy); GIS Score 1.00 (EP2006 initiated per EORTC guidelines (2010) on days 1-3 after chemotherapy)~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; EORTC=European Organization for Research and Treatment in Cancer; FN=Febrile Neutropenia; GCSF=Granulocyte Colony-Stimulating Factor; GIS=Granulocyte Colony-Stimulating Factor Initiation Score"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|The evaluable sample consists of all patients who received at least one dose of study medication, had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data)|||Percent of participants|||Number
2673836|NCT01459653|Primary|EP2006 Day of Initiation Relative to Guidelines by Cancer Type|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~^ 168 cycles in which ZARZIO® was initiated on day 4 or later involved regimens deemed by the Study Steering Committee to be suitable for GCSF initiation any day after chemotherapy (day 1 or later), e.g., etoposide; hence, these patients were re-classified as being within guidelines~DLBCL- Diffuse Large B-Cell Lymphoma. Guidelines refers to EORTC 2010 guidelines"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Number of cycles with initiation on different days during chemotherapy for evaluable sample. A patient may have initiated EP2006 during chemotherapy on different days for different cycles. The categories therefore are not mutually exclusive on a patient level and the sum of patients may therefore exceed the sample size.|||cycles|Participants||Number
2673837|NCT01459653|Primary|Percentage of Patients With Each Chemotherapy Risk Score (CRS) Result by Tumor Type|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~The CRS quantifies whether the decision to initiate EP2006 as either primary or secondary prophylaxis is consistent with the EORTC guideline (2010) recommendation based upon the patient's chemotherapy toxicity (<10%, 10-20% or >20% risk of FN) and the PRS. There are three possible results: under-treated, correctly treated, over-treated"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample: total and by tumor type|||percentage of patients|||Number
2673838|NCT01459653|Primary|Percentage of Patients With Each Prophylaxis Decision by Chemotherapy-associated FN Risk|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~FN: Febrile Neutropenia; EORTC: European Organisation for Research and Treatment of Cancer"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||percentage of participants|||Number
2673839|NCT01459653|Primary|Patient Risk Score (PRS) for Patients Receiving Chemotherapy With 10-20% FN Risk by Tumor Type|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~Patient risk score (PRS) shows the individual patient risk for FN.The PRS is a sum of eight weighted individual patient risk factors for FN and results in a possible score of 0 to 11 (highest risk for FN). The risk factors were assigned weights based on the level of risk specified by guidelines and SC consensus (age > 65 years: 3.0; advanced disease: 1.5; history of FN: 3.0; No antibiotic prophylaxis: 0.5; poor performance/nutritional status: 1.5; female gender: 0.5; Hb<12g/dL: 0.5; Renal, CV or liver disease: 0.5).~Advanced disease: Stage IV or Stage III + prior chemotherapy in metastatic setting; CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Patients with chemotherapy with 10-20% risk of FN in the evaluable sample by tumor type|||Scores on a scale||Standard Deviation|Mean
2673850|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 4|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 4. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 4|||days|Participants|Standard Deviation|Mean
2673840|NCT01459653|Primary|Patient Risk Score (PRS) for All Patients|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~Patient risk score (PRS) shows the individual patient risk for FN.The PRS is a sum of eight weighted individual patient risk factors for FN and results in a possible score of 0 to 11 (highest risk for FN). The risk factors were assigned weights based on the level of risk specified by guidelines and SC consensus (age > 65 years: 3.0; advanced disease: 1.5; history of FN: 3.0; No antibiotic prophylaxis: 0.5; poor performance/nutritional status: 1.5; female gender: 0.5; Hb<12g/dL: 0.5; Renal, CV or liver disease: 0.5).~Advanced disease: Stage IV or Stage III + prior chemotherapy in metastatic setting; CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Evaluable sample|||Scores on a scale||Standard Deviation|Mean
2673841|NCT01459653|Secondary|Characteristics of Clusters: Hemoglobin Study Start|Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|"A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.~Only patients with data in each group are analyzed for hemoglobin at study start."|||g/dL||Standard Deviation|Mean
2673842|NCT01459653|Secondary|Cohort Identification|"Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status.~A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the high risk group comprised of only 3.0% of the evaluable sample.~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|The evaluable sample consists of all patients who received at least one dose of study medication, had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data).|||participants|||Number
2673843|NCT01459653|Primary|Percentage of Patients With Each EORTC-identified Risk Factors for FN in Patients With Chemotherapy Risk 10-20% at Baseline|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~* Advanced disease is defined as Stage IV (Stage III or IV if multiple myeloma) AND prior chemotherapy in metastatic setting CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia; Hb: hemoglobin"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Patients with chemotherapy risk 10–20% in evaluable sample|||percentage of patients|||Number
2673844|NCT01459653|Primary|Percentage of Patients With Each EORTC-identified Risk Factors for FN at Baseline|"Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes.~* Advanced disease is defined as Stage IV (Stage III or IV if multiple myeloma) AND prior chemotherapy in metastatic setting. The PRS is a quantification of eight individual patient risk factors (EORTC guidelines-2010).~CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia; Hb: hemoglobin"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Evaluable sample|||percentage of participants|||Number
2673845|NCT01459653|Primary|EP2006 Duration by Chemotherapy Toxicity: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||days|Participants|Standard Deviation|Mean
2673846|NCT01459653|Primary|EP2006 Duration by Prophylaxis Type: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||days|Participants|Standard Deviation|Mean
2673847|NCT01459653|Primary|EP2006 Duration by Tumor Type: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by tumor type with data|||days|Participants|Standard Deviation|Mean
2673946|NCT01458587|Secondary|Edema at Visit 5|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|12 Weeks after PDT #1|ITT|||participants|||Number
2673851|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 3|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 3. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 3|||days|Participants|Standard Deviation|Mean
2673852|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 2|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 2. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 2|||days|Participants|Standard Deviation|Mean
2673853|NCT01459653|Primary|EP2006 Treatment Duration in Cycle 1|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of participants in evaluable sample with study drug duration in cycle 1|||days|Participants|Standard Deviation|Mean
2673854|NCT01459653|Primary|EP2006 Treatment Duration in Any Cycle|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|All cycles from patients in the evaluable sample with study drug duration|||days|Participants|Standard Deviation|Mean
2673855|NCT01459653|Primary|EP2006 Day of Initiation by Chemotherapy Toxicity: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||days|Participants|Standard Deviation|Mean
2673856|NCT01459653|Primary|EP2006 Day of Initiation by Prophylaxis Type: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||days|Participants|Standard Deviation|Mean
2673857|NCT01459653|Primary|EP2006 Day of Initiation by Tumor Type (Solid Tumor vs. Hematological Tumor): Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||days|Participants|Standard Deviation|Mean
2673858|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 6|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 6. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 6|||days|Participants|Standard Deviation|Mean
2673859|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 5|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 5. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 5|||days|Participants|Standard Deviation|Mean
2673860|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 4|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 4. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 4|||days|Participants|Standard Deviation|Mean
2673861|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 3|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 3. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 3|||days|Participants|Standard Deviation|Mean
2673862|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 2|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 2. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 2|||days|Participants|Standard Deviation|Mean
2673947|NCT01458587|Secondary|Edema at Visit 4|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|8 Weeks after PDT #1|ITT|||participants|||Number
2673863|NCT01459653|Primary|EP2006 Day of Initiation: Cycle 1|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Cycles of patients in evaluable sample with study drug initiation day at cycle 1|||days|Participants|Standard Deviation|Mean
2673864|NCT01459653|Primary|EP2006 Day of Initiation: All Cycles|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Cycles of patients in evaluable sample with day of initiation of study drug|||days|Participants|Standard Deviation|Mean
2673865|NCT01459653|Primary|EP2006 Dose by Chemotherapy Toxicity: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||cycles|Participants||Number
2673866|NCT01459653|Primary|Patient Weight by Tumor Type (Solid Tumor vs. Hematological Tumor)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by tumor type|||participants|||Number
2673867|NCT01459653|Primary|EP2006 Dose by Tumor Type: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||cycles|Participants||Number
2673868|NCT01459653|Primary|EP2006 Dose by Patient Weight: Cycle Level|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|All cycles treated|||cycles|Participants||Number
2673869|NCT01459653|Primary|EP2006 Dose (Cycle 6)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 6. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 6 with dose data|||participants|||Number
2673870|NCT01459653|Primary|EP2006 Dose (Cycle 5)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 5. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 5 with dose data|||participants|||Number
2673871|NCT01459653|Primary|EP2006 Dose (Cycle 4)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 4. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 4 with dose data|||participants|||Number
2673872|NCT01459653|Primary|EP2006 Dose (Cycle 3)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 3. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 3 with dose data|||participants|||Number
2673873|NCT01459653|Primary|EP2006 Dose (Cycle 2)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 2. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 2 with dose data|||participants|||Number
2673874|NCT01459653|Primary|EP2006 Dose (Cycle 1)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Cycle 1. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at cycle 1 with dose data|||participants|||Number
2673875|NCT01459653|Primary|EP2006 Dose (Enrollment Cycle)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|Number of participants at enrollment cycle with dose data|||participants|||Number
2674009|NCT01458561|Secondary|Amount of Postoperative Bilious Drainage||Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively|Study terminated before any subjects were enrolled into the BioFoam arm|||milliliters (mL)|||Number
2673876|NCT01459653|Primary|EP2006 Dose (All Cycles)|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|All cycles from patients in the evaluable sample|||cycles|Participants||Number
2673877|NCT01459653|Primary|Concomitant Antibiotic Prophylaxis|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days||||participants|||Number
2673878|NCT01459653|Primary|Type of EP 2006 Prophylaxis by Tumor Type|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by tumor type|||participants|||Number
2673879|NCT01459653|Primary|Type of EP 2006 Prophylaxis by Age Group|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by age|||participants|||Number
2673880|NCT01459653|Primary|Type of EP2006 Prophylaxis by Gender|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable sample by gender|||participants|||Number
2673881|NCT01459653|Primary|Type of EP2006 Prophylaxis|Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|"Delayed Primary: EP2006 initiated in cycle 2 or later with no CIN/FN in prior cycle.~True secondary: EP2006 initiated in cycle 2 or later following CIN/FN in prior cycle."|||participants|||Number
2673882|NCT01459653|Primary|Clinical Events Ever During Study (Frequency Threshold: 5%)|"Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications.~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data)|||participants|||Number
2673883|NCT01459653|Primary|Fever and Infections Ever During the Study|"Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications.~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|Evaluable consists of all patients who received at least one dose of study drug, who had no major protocol violations and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e. ANC or completed CIN/FN data).|||participants|||Number
2673884|NCT01459653|Primary|Cancer Treatment Type - Ever Received During Study|"Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications.~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;"|All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days|The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data).|||participants|||Number
2673894|NCT01459588|Secondary|Change From Baseline in Tear Break-up Time|Tear Break-up Time (TBUT) was assessed at Baseline and Day 30. TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The shorter the tear break-up time, the worse the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive change from baseline indicates improvement.|Baseline, Day 30|Intent-to-treat population included all randomized participants.|||Seconds||Standard Deviation|Mean
2674348|NCT01456494|Secondary|Number of Participants Reporting Acute Health-related Events 30 Days Post Hospital Discharge Between TTG and BI||30 days (Visits V0-V2, ie from initial hospital visit to the 30 day post discharge phone interview)||||Participants|||Count of Participants
2673885|NCT01459653|Primary|Chemotherapy Toxicity (%FN Risk)|"Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications.~Chemotherapy regimens were classified for FN risk (<10% risk, 10-20% risk or >20% risk) according to the published rates in the EORTC Guidelines under consideration of agent(s) and schedules.~ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;"|Enrollment cycle. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician.|The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data. Please refer to baseline characteristics tables as well.|||participants|||Number
2673886|NCT01459614|Secondary|Overall Survival (OS)|OS (in months) will be measured from date of first dose until death (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.|Up to 28 months|Outcome was assessed for the Primary Cohort only per protocol. One patient was consented and enrolled, but was not considered evaluable per protocol, as he came off study prior to completing a cycle of treatment for reasons other than disease progression or death.|||Months||95% Confidence Interval|Median
2673887|NCT01459614|Secondary|Progression-free Survival (PFS)|PFS is defined as the the number of months from the date of first dose to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause . Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.|Up to 21 months|One patient was consented and enrolled, but was not considered evaluable per protocol, as he came off study prior to completing a cycle of treatment for reasons other than disease progression or death.|||Months||95% Confidence Interval|Median
2673888|NCT01459614|Secondary|Disease Control Rate (DCR)|DCR is defined as the percentage of patients achieving a complete response (CR), partial response (PR), or stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.|Up to 22 months|Outcome was assessed for the Primary Cohort only per protocol. One patient was consented and enrolled, but was not considered evaluable per protocol, as he came off study prior to completing a cycle of treatment for reasons other than disease progression or death.|||Percentage of Participants||95% Confidence Interval|Number
2673889|NCT01459614|Secondary|Number of Patients Experiencing a Grade 3 or Above Treatment-related Toxicity|When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v4.03) will be counted only once for a given subject. AEs collected from time of first dose of study drug through 28 days after the last dose of study drug. The median duration of treatment was up to 23 months.|Up to 23 months||||Participants|||Count of Participants
2673890|NCT01459614|Primary|Percentage of Participants Without Disease Progression (Progression-Free Survival) at 6 Months|PFS is defined as the percentage of patients with disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause at 6 months. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.|6 months|One patient was consented and enrolled, but was not considered evaluable per protocol, as he came off study prior to completing a cycle of treatment for reasons other than disease progression or death.|||percentage of participants||95% Confidence Interval|Number
2673891|NCT01459588|Secondary|Change From Baseline in Schirmer Test Results|The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive number change from baseline indicates an increase in tears (improvement).|Baseline, Day 30|Intent-to-treat population included all randomized participants.|||millimeters||Standard Deviation|Mean
2673892|NCT01459588|Secondary|Change From Baseline in Conjunctival Staining|The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement).|Baseline, Day 30|Intent-to-treat population included all randomized participants.|||Score on as scale||Standard Deviation|Mean
2673893|NCT01459588|Secondary|Change From Baseline in Corneal Staining|The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0= no staining, 5 = severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in corneal staining (improvement).|Baseline, Day 30|Intent-to-treat population included all randomized participants.|||Score on a scale||Standard Deviation|Mean
2673945|NCT01458587|Secondary|Stinging/Burning at Baseline|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|Baseline|ITT, observed|||participants|||Number
2673895|NCT01459588|Primary|Change From Baseline in Ocular Surface Disease Index© Questionnaire Score|The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement.|Baseline, Day 30|Intent-to-treat population included all randomized participants.|||Score on a scale||Standard Deviation|Mean
2673896|NCT01459068|Secondary|Alcohol Use|Alcohol use was measured using the Alcohol Use Disorders Identification Test (AUDIT). Respondents reported frequency and amount of alcohol consumed, referencing photographs of local alcohols (local beers, rice whiskeys, etc.). Total scores were calculated as sum totals across the 10-item scale. AUDIT total scores ranged from 0 (best possible outcome) to 40 (worst possible outcome).|10-16 weeks||||units on a scale||Standard Error|Mean
2673897|NCT01459068|Secondary|Aggression Behaviors|"The 12-item Aggression Questionnaire (AQ) was adapted for local use. Respondents rated frequency in general of aggressive behaviors from 0 None of the time to 4 Almost all of the time. Scores were calculated as averages scores for each behavior across the 12-item scale and therefore ranged from 0-4"|10-16 weeks||||units on a scale||Standard Error|Mean
2673898|NCT01459068|Secondary|Anxiety Symptoms|Anxiety symptoms were measured using the 10-item HSCL-25 anxiety subscale with local adaptations. Respondent instructions and response categories were the same as the HSCL-25 depression subscale. Scores were calculated as average symptom scores across the 11-item scale and therefore ranged from 0-4|10-16 weeks||||units on a scale||Standard Error|Mean
2673899|NCT01459068|Primary|Posttraumatic Stress Symptoms|Posttraumatic stress symptoms (PTSS) were measured using the 30-symptom items of the Harvard Trauma Questionnaire (HTQ). Response options were the same as the HSCL-25. An algorithm was applied to the HTQ to determine eligibility on the basis of moderate to severe PTSS. The HTQ was also used to measure the PTSS severity outcome: Scores for PTSS were calculated as average symptom scores across the 30 items. PTSS scores ranged from 0 (best possible outcome) to 3 (worst possible outcome).|10-16 weeks||||units on a scale||Standard Error|Mean
2673900|NCT01459068|Secondary|Functional Impairment|"Functional impairment was measured using locally-developed, gender-specific scales. The scales contained 16 and 23 tasks for men and women, respectively. Respondents reported current difficulty compared to others of same gender and similar age (from 0 No difficulty to 4 Often cannot do). Scores were calculated as average task scores across the 16- and 23-item scales and therefore ranged from 0-4"|10-16 weeks||||units on a scale||Standard Error|Mean
2673901|NCT01459068|Primary|Depression|"Depression symptoms were measured using a modified, locally validated version of the 15-item Hopkins Symptoms Checklist (HSCL-25) depression subscale. Respondents reported symptom frequency in the last month (0 None of the time to 3 Almost always). An algorithm was applied to the HSCL-25 to determine eligibility on the basis of moderate to severe depression. The HSCL-25 was also used to measure the depression severity outcome: Scores on the depression scale were calculated as average symptom scores across the 17 items and therefore ranged from 0-3"|10-16 weeks||||units on a scale||Standard Error|Mean
2673902|NCT01459016|Secondary|Change From Baseline in the Clinical Dementia Rating (CDR) Total Score|The CDR is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score ranges from 0 to 18. Higher scores indicate greater disease severity. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and completed the scale at the designated time point.|||units on a scale||95% Confidence Interval|Least Squares Mean
2673903|NCT01459016|Secondary|Change From Baseline in the Alzheimer's Disease Assessment Scale Extended Cognitive Subscale (ADAS-Cog14) Total Score|The ADAS-Cog14 is the ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and completed the scale at the designated time point.|||units on a scale||95% Confidence Interval|Least Squares Mean
2673904|NCT01459016|Secondary|Change From Baseline in the Mini Mental State Examination (MMSE) Total Score|The MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures). Total score ranges from 0 to 30; lower score indicates greater disease severity. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and completed the scale at the designated time point.|||units on a scale||95% Confidence Interval|Least Squares Mean
2673905|NCT01459016|Secondary|Number of Participants With Microhemorrhage on MRI Scan at a Field Strength of 3T||Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.|||Participants|||Count of Participants
2673906|NCT01459016|Secondary|Number of Participants With Vasogenic Edema on MRI Scan at a Field Strength of 3 Tesla (3T)||Baseline|All participants who had an MRI during screening and were classified as screen failures.|||Participants|||Count of Participants
2673907|NCT01459016|Secondary|Baseline Brain Amyloid Load Using Positron Emission Tomography (PET) and Florbetapir|Composite summary standardized uptake value ratio (SUVR) normalized to mean whole cerebellum. Regions used for composite summary were posterior cingulum, anterior cingulum, parietal cortex, lateral temporal cortex and frontal cortex.|Baseline|All participants with an amyloid positive florbetapir F 18 PET scan at baseline.|||SUVR unit 1||Standard Deviation|Mean
2673908|NCT01459016|Primary|Change From Baseline in Diffusion Tensor Imaging (DTI) Using Mean Diffusivity (MD)|DTI scans used MD to measure the overall magnitude of water diffusion in selected WM tracts, without specific regard to directionality. ROI: CC, IC, PCB, TWM, UF, SLF. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.|||square meters per second (m²/sec) * 10¹⁰||95% Confidence Interval|Least Squares Mean
2674349|NCT01456494|Secondary|Number of Participants Misusing Diskus Post Education Between TTG and BI||1 hour at the V0-V1 initial hospital study visit||||Participants|||Count of Participants
2673909|NCT01459016|Primary|Change From Baseline in Diffusion Tensor Imaging (DTI) Using Fractional Anisotropy (FA)|DTI scans used FA to measure water diffusion directionality in selected white matter (WM) tracts. ROI: Corpus collosum (CC), internal capsule (IC), posterior cingulum bundle (PCB), temporal white matter (TWM), uncinate fasciculus (UF), superior longitudinal fasciculus (SLF). LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.|||au||95% Confidence Interval|Least Squares Mean
2673910|NCT01459016|Primary|Change From Baseline in Resting State Functional Magnetic Resonance Imaging (rsfMRI)|Distributed functional connectivity in selected brain networks was calculated from the rsfMRI scans. Values were derived from low-frequency (0.01-0.1 hertz [Hz]) temporal correlations between different regions over the approximately 6-minute rsfMRI time series scan. Distributed measures of functional connectivity were calculated as the mean Pearson correlation between the average low-frequency time courses in predefined sets of regions of interest (ROI) within the default mode network (DMN), salience network (SN) and sensorimotor networks (SMN). LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.|||arbitrary units (au)||95% Confidence Interval|Least Squares Mean
2673911|NCT01459016|Primary|Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Hippocampus Volume Average Percent (%) Change (Chg)|Automated hippocampal volumetry was performed using the Learning Embeddings for Atlas Propagation (LEAP) algorithm. LS mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.|||percentage of hippocampus volume average||95% Confidence Interval|Least Squares Mean
2673912|NCT01459016|Primary|Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI) - Brain Boundary Shift Integral (BBSI) and Ventricular Boundary Shift Integral (VBSI)|BBSI and VBSI were calculated based on the voxel-wise difference between co-registered baseline and follow-up scans. Least squares (LS) mean value was controlled for baseline value and visit.|Baseline, 6 Mos; Baseline, 12 Mos|All participants who enrolled in the study and had an evaluable MRI at the designated time point.|||milliliters (mL)||95% Confidence Interval|Least Squares Mean
2673913|NCT01458990|Secondary|Number of Patients With Adverse Events During Initiation or Withdrawal of PPI Therapy|Analysis at baseline will be compared to that at 2 weeks. This will be specifically, changes in those with PPI withdrawal compared to those with PPI initiation|2 weeks|No safety or tolerability issues were seen during the study|||Participants|||Count of Participants
2673914|NCT01458990|Primary|Number of Patients With Overgrowth of Oral Microbiota in Their Stool After PPI Therapy Withdrawal or Initiation|Analysis at baseline will be compared to that at 2 weeks using Multitagged sequencing. Number of patients with overgrowth of oral microbiota in their stool after PPI therapy withdrawal or initiation were specifically analyzed.|2 weeks|Comparison were made between groups on/off PPI therapy using Linear discriminant analysis effect size (LEFSe) and using the Quantitative Insights Into Microbial Ecology (QIIME) pipeline and also the relative proportion (%) of oral-origin microbiota were studied|||Participants|||Count of Participants
2673915|NCT01458951|Secondary|Change From Baseline in Total Mayo Score at Week 8|Change in total Mayo scores at Week 8 relative to Baseline was reported. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Baseline, Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2673916|NCT01458951|Secondary|Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8|Change in Partial Mayo scores at Weeks 2, 4, 8 relative to baseline were reported. A Partial Mayo Score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each graded from 0 to 3 with higher scores indicating more severe disease.|Baseline, Weeks 2, 4, 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Error|Least Squares Mean
2673917|NCT01458951|Secondary|Partial Mayo Scores|A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) and each grading from 0 to 3 with higher scores indicating more severe disease.|Baseline, Weeks 2, 4, 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2673918|NCT01458951|Secondary|Percentage of Participants With Deep Remission at Week 8|Deep remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
2673919|NCT01458951|Secondary|Percentage of Participants With Symptomatic Remission at Week 8|Symptomatic remission was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
2673920|NCT01458951|Secondary|Percentage of Participants With Clinical Remission at Week 8|Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
2673921|NCT01458951|Secondary|Percentage of Participants With Endoscopic Remission at Week 8|Endoscopic remission in participants was defined by Mayo endoscopic subscore of 0. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
2673922|NCT01458951|Secondary|Percentage of Participants Achieving Clinical Response at Week 8|Clinical response in participants was defined by a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding sub score of at least 1 point or an absolute rectal bleeding sub score of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible centrally read proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
2673923|NCT01458951|Secondary|Percentage of Participants Achieving Mucosal Healing at Week 8|Mucosal healing in participants was defined by Mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
2673924|NCT01458951|Primary|Percentage of Participants With Remission at Week 8|Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of Ulcerative Colitis . It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.|Week 8|Full analysis set included all participants who were randomly assigned to either tofacitinib 10 mg BID or placebo BID.|||percentage of participants|||Number
2673925|NCT01458639|Secondary|Safety of Technegas in Patients With Possible PE|Safety will be assessed by the incidence of treatment emergence adverse events and changes in clinical laboratory measurements, blood pressure, oxygen saturation, physical examination and pulmonary examination before and after treatment.|Prospective, from enrollment through 30 days follow-up|All subjects who received Technegas and completed safety follow-up procedures.|||participants|||Number
2673926|NCT01458639|Secondary|Likelihood Ratio for Diagnosis of PE|Likelihood ratios of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.|Prospective, 30 days follow-up|PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.||||||
2673927|NCT01458639|Secondary|Negative Predictive Value (NPV) of Imaging for Diagnosis of PE|NPV of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.|Prospective, 30 days follow-up|PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.||||||
2673928|NCT01458639|Secondary|Positive Predictive Value (PPV) of Imaging for Diagnosis of PE|PPV of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.|Prospective, 30 days follow-up|PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.||||||
2673929|NCT01458639|Secondary|Accuracy of Technegas V/Q SPECT and Xenon V/Q Planar Imaging for Diagnosis of PE|Accuracy of V/Q imaging for diagnosis of PE is determined by the results of blind-read assessment of images compared with truth using a subject's final clinical diagnosis following 30-day follow-up of occurence of PE or death, whichever occurs first.|prospective, 30 days follow-up.|PE adjudication for final clinical diagnosis was to be determined by an Independent Adjudication Committee and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary and secondary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.||||||
2673930|NCT01458639|Primary|Specificity of Technegas V/Q SPECT for the Diagnosis of PE.|"Compared to the specificity of Xenon V/Q Planar imaging. Truth based on blinded reader's assessments of V/Q SPECT images compared with subject's final diagnosis resulting from clinical information at 30 days follow-up."|Prospective, 30 days follow-up|Pulmonary embolism adjudication was to be determined by an Independent Adjudication Committee for primary and secondary outcome data and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.||||||
2673931|NCT01458639|Primary|Sensitivity of Technegas V/Q SPECT for the Diagnosis of PE|"Compared to the sensitivity of Xenon V/Q Planar imaging. Truth based on blinded reader's assessments of V/Q SPECT images compared with subject's final diagnosis resulting from clinical information at 30 days follow-up."|Prospective, 30 days follow-up|Pulmonary embolism adjudication was to be determined by an Independent Adjudication Committee for primary and secondary outcome data and blinded readings of Xe-133 and Technegas Ventilation and Tc-99m MAA Perfusion images were required for primary outcome data. Due to trial termination PE adjudication and blinded readings of images were not done.||||||
2673932|NCT01458587|Secondary|OOZING/VESICULATION/CRUSTING at Visit 5|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|12 Weeks after PDT #1|ITT observed|||participants|||Number
2673933|NCT01458587|Secondary|OOZING/VESICULATION/CRUSTING at Visit 4|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|8 Weeks after PDT #1|ITT observed|||participants|||Number
2673934|NCT01458587|Secondary|OOZING/VESICULATION/CRUSTING at Visit 3|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Week 2 after PDT #1|ITT observed|||participants|||Number
2673935|NCT01458587|Secondary|OOZING/VESICULATION/CRUSTING at Baseline|OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above|Baseline|ITT observed|||participants|||Number
2673936|NCT01458587|Secondary|Scaling and Dryness at Visit 5|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|12 Weeks Post PDT #1|ITT observed|||participants|||Number
2673937|NCT01458587|Secondary|Scaling and Dryness at Visit 4|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|8 Weeks Post PDT #1|ITT observed|||participants|||Number
2673938|NCT01458587|Secondary|Scaling and Dryness at Visit 3|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|2 Weeks Post PDT #1|ITT observed|||participants|||Number
2673939|NCT01458587|Secondary|Scaling and Dryness at Baseline|﻿SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling|Baseline|ITT observed|||participants|||Number
2673940|NCT01458587|Secondary|Stinging/Burning at Visit 5|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|12 Weeks after PDT #1|ITT, observed|||participants|||Number
2673941|NCT01458587|Secondary|Stinging/Burning at Visit 4|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|8 Weeks after PDT #1|ITT, observed|||participants|||Number
2673942|NCT01458587|Secondary|Stinging/Burning at Visit 3|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|2 Weeks after PDT #1|ITT, observed|||participants|||Number
2673943|NCT01458587|Secondary|Stinging/Burning Post Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|5 minutes after PDT #1|ITT, observed|||participants|||Number
2673944|NCT01458587|Secondary|Stinging/Burning During Light Treatment|﻿STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable|During PDT #1|ITT, observed|||participants|||Number
2673948|NCT01458587|Secondary|Edema at Visit 3|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|2 Weeks after PDT #1|ITT|||participants|||Number
2673949|NCT01458587|Secondary|Edema Post-Light Treatment|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|5 Minutes after PDT #1|ITT|||participants|||Number
2673950|NCT01458587|Secondary|Edema at Baseline|﻿EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area|Baseline|ITT|||participants|||Number
2673951|NCT01458587|Secondary|Erythema at Visit 5|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|12 Weeks after PDT #1|ITT|||participants|||Number
2673952|NCT01458587|Secondary|Erythema at Visit 4|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|8 Weeks after PDT #1|ITT|||participants|||Number
2673953|NCT01458587|Secondary|Erythema at Visit 3|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|2 Weeks after PDT #1|ITT|||participants|||Number
2673954|NCT01458587|Secondary|Erythema Post-Light Treatment|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|5 Minutes after PDT #1|ITT|||participants|||Number
2673955|NCT01458587|Secondary|Erythema at Baseline|Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema|Baseline|ITT|||participants|||Number
2673956|NCT01458587|Secondary|Hypopigmentation at Visit 5|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|12 Weeks after PDT #1|ITT|||participants|||Number
2673957|NCT01458587|Secondary|Hypopigmentation at Visit 4|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|8 Weeks after PDT #1|ITT|||participants|||Number
2673958|NCT01458587|Secondary|Hypopigmentation at Visit 3|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|2 Weeks after PDT #1|ITT|||participants|||Number
2673959|NCT01458587|Secondary|Hypopigmentation at Baseline|HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation|Baseline|ITT|||participants|||Number
2673960|NCT01458587|Secondary|Hyperpigmentation at Visit 5|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|12 weeks after PDT #1|ITT|||participants|||Number
2673961|NCT01458587|Secondary|Hyperpigmentation at Visit 4|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|8 weeks after PDT #1|ITT|||participants|||Number
2673962|NCT01458587|Secondary|Hyperpigmentation at Visit 3|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|2 weeks after PDT #1|ITT|||participants|||Number
2673963|NCT01458587|Secondary|Hyperpigmentation at Baseline|HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas|Baseline|ITT|||participants|||Number
2673964|NCT01458587|Secondary|Subject Satisfaction Score|"Subject satisfaction score~= Excellent (very satisfied)~= Good (moderately satisfied)~= Fair (slightly satisfied)~= Poor (not satisfied at all)"|Week 12|ITT|||participants|Participants||Number
2673965|NCT01458587|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline and Week 12|ITT LOCF|||arms >75% cleared|Participants||Number
2673966|NCT01458587|Secondary|Partial Clearance Rate|proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.|Baseline and Week 8|ITT LOCF|||arms >75% cleared|Participants||Number
2673967|NCT01458587|Secondary|Complete Clearance Rate|proportion of subjects with a count of zero lesions in the treatment area|Week 12|ITT LOCF|||arms 100% cleared|Participants||Number
2673968|NCT01458587|Secondary|Complete Clearance Rate|proportion of subjects with a count of zero lesions in the treatment area|Week 8|ITT LOCF|||arms 100% cleared|Participants||Number
2673969|NCT01458587|Secondary|Lesion Clearance Rate||Week 8|ITT LOCF|||percentage of lesions cleared|Participants|Standard Deviation|Median
2673970|NCT01458587|Primary|Lesion Clearance Rate|Clearance rate for all lesions|Week 12|ITT analysis with LOCF|||percentage of lesions cleared|Participants|Standard Deviation|Median
2673971|NCT01458574|Secondary|Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline|Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission were reported in this outcome measure.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2673972|NCT01458574|Secondary|Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline|Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with steroid-free remission were reported in this outcome measure.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2673973|NCT01458574|Secondary|Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline|Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants in steroid-free remission were reported in this outcome measure.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2673974|NCT01458574|Secondary|Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline|Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2674010|NCT01458561|Secondary|Intraoperative Blood Loss|Amount of blood lost between time of initial application of prescribed hemostatic agent and confirmed achievement of hemostasis (achievement of hemostasis eval. out to 10 minutes following application of prescribed hemostatic agent)|Time from initial application to confirmed achievement of hemostasis (eval. up to 10 minutes following application of hemostatic agent)|Study terminated before appropriate data collection/analysis||||||
2673975|NCT01458574|Secondary|Percentage of Participants in Remission, Among Participants With Remission at Baseline|Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2673976|NCT01458574|Secondary|Change From Baseline in Total Mayo Score at Week 24 and 52|Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Change from baseline in total mayo score at Week 24 and 52 was reported.|Baseline, Week 24, 52|FAS included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Error|Least Squares Mean
2673977|NCT01458574|Secondary|Total Mayo Score at Baseline, Week 24 and 52|Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Baseline, Week 24, 52|FAS included all randomized participants. Here, ‘n’ signifies those participants who were evaluable at specified time point for each arm, respectively.|||units on a scale||Standard Deviation|Mean
2673978|NCT01458574|Secondary|Percentage of Participants in Sustained Endoscopic Remission|Sustained endoscopic remission in participants was defined as being in endoscopic remission at both Week 24 and Week 52. Endoscopic remission was defined by a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
2673979|NCT01458574|Secondary|Percentage of Participants in Endoscopic Remission at Week 24 and 52|Endoscopic remission in participants was defined as a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
2673980|NCT01458574|Secondary|Percentage of Participants in Sustained Symptomatic Remission|Sustained symptomatic remission in participants was defined as being in symptomatic remission at both Week 24 and Week 52. Symptomatic remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
2673981|NCT01458574|Secondary|Percentage of Participants in Symptomatic Remission at Week 24 and 52|Symptomatic remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub-scores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
2673982|NCT01458574|Secondary|Percentage of Participants in Sustained Deep Remission|Sustained deep remission was defined by being in deep remission at both Week 24 and Week 52. Deep remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
2673983|NCT01458574|Secondary|Percentage of Participants in Deep Remission at Week 24 and 52|Deep remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
2673984|NCT01458574|Secondary|Percentage of Participants in Sustained Clinical Remission|Sustained clinical remission in participants was defined as being in clinical remission at both Week 24 and Week 52. Clinical remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
2673985|NCT01458574|Secondary|Percentage of Participants in Clinical Remission at Week 24 and 52|Clinical remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
2673986|NCT01458574|Secondary|Percentage of Participants With Sustained Clinical Response|Sustained clinical response in participants was defined as showing clinical response at both Week 24 and Week 52. Clinical response was defined by a decrease from induction study (A3921094 [NCT01465763] or A3921095 [NCT01458951]) baseline in mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point, or an absolute rectal bleeding subscore of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained clinical response are reported in this outcome measure.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
2673987|NCT01458574|Secondary|Percentage of Participants With Clinical Response at Week 24 and 52|Clinical response was defined by a decrease from induction study (A3921094 [NCT01465763] or A3921095 [NCT01458951]) baseline in Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point, or an absolute rectal bleeding subscore of 0 or 1. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with clinical response at Week 24 and 52 have been reported in this outcome measure.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
2673988|NCT01458574|Secondary|Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline|Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2673989|NCT01458574|Secondary|Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline|Mucosal healing in participants was defined as achieving mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2673990|NCT01458574|Secondary|Percentage of Participants With Sustained Mucosal Healing|Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
2673991|NCT01458574|Secondary|Percentage of Participants With Mucosal Healing at Week 24|Mucosal healing in participants was defined by a mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.|Week 24|FAS included all randomized participants.|||percentage of participants|||Number
2673992|NCT01458574|Secondary|Percentage of Participants in Sustained Remission|Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.|Week 24, 52|FAS included all randomized participants.|||percentage of participants|||Number
2673993|NCT01458574|Secondary|Percentage of Participants in Remission at Week 24|Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.|Week 24|FAS included all randomized participants.|||percentage of participants|||Number
2674011|NCT01458561|Secondary|Achievement of Immediate Hemostasis|Number of subjects achieving hemostasis at 1 minute after application of prescribed hemostatic agent|1 minute after application of prescribed hemostatic agent|Study was terminated before any subjects were enrolled into the BioFoam arm|||participants|||Number
2674012|NCT01458561|Secondary|Time to Hemostasis|"Number of subjects achieving hemostasis [by assessing for hemostasis (yes/no)] at pre-determined time points: 1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent. Time to hemostasis is recorded as the first of the predetermined time points to receive a yes assessment."|1, 3, 5, 7, and 10 minutes following application of prescribed hemostatic agent|Study terminated before any subjects were enrolled into the BioFoam arm|||minutes|||Number
2674350|NCT01456494|Primary|Number of Participants Misusing Metered-Dose Inhaler (MDI) Post Education Between Teach to Goal (TTG) and Brief Intervention (BI)||1 hour at the V0-V1 initial hospital study visit||||Participants|||Count of Participants
2673994|NCT01458574|Secondary|Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline|Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission (among participants with remission at baseline) were reported in this outcome measure.|Week 24, 52|"FAS included all randomized participants. Here number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percentage of participants|||Number
2673995|NCT01458574|Secondary|Percentage of Participants With Mucosal Healing at Week 52|Mucosal healing in participants was defined by mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.|Week 52|FAS included all randomized participants.|||percentage of participants|||Number
2673996|NCT01458574|Primary|Percentage of Participants In Remission at Week 52|Remission in participants was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12 where higher score indicating higher disease severity.|Week 52|FAS included all randomized participants.|||percentage of participants|||Number
2673997|NCT01458561|Secondary|Number of Procedure Complications and/or Adverse Events||Through final follow-up (2 years postoperatively)||||Number of complications and AEs|||Number
2673998|NCT01458561|Secondary|Evaluation of Anti-Bovine Serum Albumin (Anti-BSA) Antibody Titers|Evaluation of anti-BSA antibody titers to determine number of subjects/participants with a positive titer at various time points|Preoperatively (up to 30 days before surgery), immediately post-application of hemostatic agent (within minutes), within 48 hrs postoperatively, up to 48 hrs before hospital discharge, at 7-10 days, 30 days, 3 mos, 6 mos, 9 mos, 1 yr, and 2 yr postop|Blood samples were to be analyzed in batches to more accurately assess for any changes over time; the study was terminated before the first batch was analyzed, so no data is available for anti-BSA titer testing.||||||
2673999|NCT01458561|Secondary|Subjects Requiring Additional Hospitalization/Surgical Intervention|Number of subjects requiring additional hospitalization/surgical intervention following final wound closure through the 2 year follow-up|Any hospitalization/surgical intervention following final wound closure through 2 year follow-up visit (average 2 yr duration)|Study terminated before any subjects were enrolled into the BioFoam arm|||# of participants|||Number
2674000|NCT01458561|Secondary|Total Hospitalization Time|Length of time between hospital admission (day of surgery) and hospital discharge (average 5-7 days)|Hospital admission (day of surgery) until hospital discharge (average 5-7 days)|Study terminated before any subjects were enrolled into the BioFoam arm|||days|||Number
2674001|NCT01458561|Secondary|Core Body Temperature||At the time of test or control article application (expected average 3-4 hours from skin cut)|Study terminated before any subjects were enrolled into the BioFoam arm|||degrees Celcius|||Number
2674002|NCT01458561|Secondary|Total Time of Operative Procedure||Skin cut to skin closure (average 4-5 hour duration)|Study terminated before any subjects were enrolled into the BioFoam arm|||minutes|||Number
2674003|NCT01458561|Secondary|Number of Subjects Requiring Reoperation Due to Bleeding and/or Biliary Leakage (Reoperation Required? y/n)|Number of subjects requiring reoperation due to bleeding and/or biliary leakage out to 2 years postoperatively (reoperation required? y/n)|After final wound closure through 2 year follow-up visit (average 2 yr duration)|Study terminated before any subjects were enrolled into the BioFoam arm|||number of participants|||Number
2674004|NCT01458561|Secondary|Eval. for Presence of Device by MRI w/ & w/Out Contrast, & Diagnose/Eval. Abdominal Fluid Collection/Biliary Leak, Residual Scarring, Hepatic Regeneration, & Assess for Emergence of Primary/Recurrent Malignancy by MRI w/ or w/Out Contrast as Appropriate||Within 48 hours postoperatively, up to 48 hours prior to hospital discharge (avg. 5-7 days postoperatively), and 30 days, 3 months, 6 months, 9 months, 1 year, and 2 years postoperatively||||participants|||Number
2674005|NCT01458561|Secondary|Subject Laboratory Evaluations|Number of laboratory evaluations outside of range from preoperative assessments through final 2 year follow-up|Preoperatively through final 2 year follow-up|Study terminated before any subjects were enrolled into the BioFoam arm|||Number of participants with labs in rang|||Number
2674006|NCT01458561|Secondary|Amount of Intraoperative Blood Products Administered|Amount of blood products administered intraoperatively (throughout procedure: from initial skin cut to final wound closure)|Intraoperatively (throughout procedure, from initial skin cut to final wound closure, average 4-5 hours duration)|Study terminated before any subjects were enrolled into the BioFoam arm|||units of blood product(s)|||Number
2674007|NCT01458561|Secondary|Duration of Drainage|Total length of time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively|Time between drain insertion and last recorded emptying time during hospitalization (where applicable), average 24-72 hours postoperatively|Study terminated before any subjects were enrolled into the BioFoam arm|||hours|||Number
2674008|NCT01458561|Secondary|Amount of Postoperative Fluid Loss|Amount of fluid lost postoperatively [measured between time of drain insertion (if applicable) to drain removal, average 24-72 hours postoperatively]|Time from drain insertion to drain removal (where applicable), average 24-72 hours postoperatively|Study terminated before any subjects were enrolled into the BioFoam arm|||milliliters (mL)|||Number
2674351|NCT01456299|Secondary|Frequency of Apnea|If prolonged apnoea (> 30 s) developed, manual ventilation was assisted. And record the frequency of apnea on each group|baseline, 30sec after drug injection|||||||
2674013|NCT01458561|Primary|Time to Achieve Intraoperative Hemostasis Following Open Liver Resection Surgery in Subjects Receiving an Application of BioFoam or a Standard Topical Hemostatic Agent|Number of subjects achieving intraoperative hemostasis (y/n) at 3 minutes following a single application of the prescribed hemostatic agent|3 minutes following a single application of the prescribed hemostatic agent|Study was terminated before any subjects were enrolled into the BioFoam arm|||participants|||Number
2674014|NCT01458535|Secondary|Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks)|Virologic relapse is defined as confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) >= lower limit of quantitation (LLOQ) (2 consecutive measurements >= LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment. Participants with missing data were imputed as failures.|Post-treatment Day 1 to Post-treatment Week 48|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT) with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ) at the final treatment visit who completed treatment.|||percentage of participants|||Number
2674015|NCT01458535|Secondary|Percentage of Participants With Virologic Failure During Treatment|Virologic failure during treatment is defined as a participant meeting any virologic stopping criteria, including 1) rebound (defined as the first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value), or first day of 2 consecutive HCV RNA >= LLOQ for participants who previously achieved HCV RNA < LLOQ) during treatment, 2) participant who fails to suppress (defined as never achieving HCV RNA < LLOQ during treatment).|Day 1 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants|||Number
2674016|NCT01458535|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR)|Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.|Week 4|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants|||Number
2674017|NCT01458535|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)|Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2. Participants with missing data were imputed as failures.|Week 2|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants|||Number
2674018|NCT01458535|Secondary|Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment|Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug. Participants with missing data were imputed as failures.|Post-treatment Day 1 to Post-treatment Week 24|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants|||Number
2674019|NCT01458535|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment|Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.|Post-treatment Day 1 to Post-treatment Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants|||Number
2674020|NCT01458535|Primary|Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)]|Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.|Week 4 through Week 12|Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).|||percentage of participants|||Number
2674021|NCT01458522|Secondary|Percentage of All Subjects Who Have Had a Seizure, Are on Antiepileptic Drug (AED) Therapy, and Are Alive/Dead at Day 30|Percentage of all subjects who have had a seizure, are on antiepileptic drug (AED) therapy, and are alive and dead at day 30. Data was acquired in a manner consistent with determining if one treatment arm (LCM first, then fPHT versus fPHT first, then LCM) resulted in a greater effect on seizures, antiepileptic drug (AED) use, and survival at day 30 after the acute treatment period. The acute treatment period could range from 6 to 30 hours.|both acute treatment periods to 30 days||||percentage of participants|||Number
2674022|NCT01458522|Secondary|Change in Functional Status as Measured by the Functional Disability Scale at Day 7 to 9 Postrandomization and Day 30 Post-randomization in the LCM vs fPHT Arms.|Change in functional status as measured by the Functional Disability Scale, using a 0-29 rating (0=w/o disability; 29=extreme vegetative state) at Day 7 to 9 postrandomization and Day 30 post-randomization in the LCM first, then fPHT versus fPHT first, then LCM arms. Data was analyzed in a manner consistent with determining if one treatment arm resulted in a greater change in functional status than the other.|Baseline to day 7-9, baseline to day 30|participants who completed the Functional Disability Scale|||units on a scale||Standard Deviation|Mean
2674023|NCT01458522|Secondary|Days in the Intensive Care Unit/Hospital|Data was acquired in a manner consistent with determining if one treatment arm (LCM first, then fPHT versus fPHT first, then LCM) resulted in more days of hospitalization than the other over the course of the study.|initial bolus to end of study||||days||Standard Deviation|Mean
2674024|NCT01458522|Secondary|Percentage of Subjects in Whom Study Drug is Withdrawn Early After Treatment With Treatment Arm 1|Percentage of subjects in whom study drug is withdrawn early after treatment with treatment arm 1|baseline to end of treatment arm 1||||Participants|||Count of Participants
2674025|NCT01458522|Secondary|Number of Predefined Adverse Events (AE) After Treatment Arm 1 Administration|Number of predefined adverse events (AE) after treatment arm 1 administration. These predefined adverse events include Patients with at least one AE of interest, Cardiac disorders, investigations, suspected hypersensitivity reactions, vascular disorders, and hypotension.|24 hours|Patients who received treatment arm 1|||Number of predefined AEs|||Number
2674048|NCT01458288|Secondary|the Average Number of Leukapheresis Sessions|To determine the average number of leukapheresis sessions required to collect 2.5 x10^6 CD34+ cells/kg.|1 week||||number of leukapheresis sessions||Standard Deviation|Mean
2674026|NCT01458522|Secondary|Time of First Bolus to End of Seizures After Initial Treatment Arm, Time From Crossover to End of Seizures in Crossover Treatment Arm|Time of first bolus to end of seizures after initial treatment arm, time from crossover to end of seizures in crossover treatment arm|time of first bolus to end of seizures after initial treatment arm, time from crossover to end of seizures in crossover treatment arm|participants who had satisfactory EEG data (sometimes EEG leads would come off)|||hours||Standard Deviation|Mean
2674027|NCT01458522|Secondary|Seizure Burden Change From Baseline to End of Crossover, Excluding Initial Treatment Arm|Absolute change defined as the number of minutes of ESz activity per hour before treatment and at the end of the second treatment arm. This measure does not evaluate seizure activity in the first treatment arm. If less than 1 hour of recording time is available, seizure time will be extrapolated to 1 hour.|baseline, 26-68 hours|participants who had satisfactory EEG data (sometimes EEG leads would come off)|||min/hour||Standard Deviation|Mean
2674028|NCT01458522|Secondary|Seizure Burden Change From Baseline to End of Initial Treatment|Absolute change in seizure time (defined as the number of minutes of electrographic seizure (ESz) activity per hour) before treatment and at the end of the first treatment arm. If less than 1 hour of recording time is available, seizure time will be extrapolated to 1 hour. The maximum amount of time that can be used to determine baseline seizure time is 6 hours.|Baseline, 24 hours|Participants who had satisfactory EEG data (sometimes EEG leads would come off)|||min/hour||Standard Deviation|Mean
2674029|NCT01458522|Secondary|Number of Subjects Who Required a Second Antiepileptic Drug (AED) to Control Nonconvulsive Seizures (NCS)|Number of subjects who required a second antiepileptic drug (AED) to control nonconvulsive seizures (NCS)|24-26 hours|Participants who crossed over to second drug|||Participants|||Count of Participants
2674030|NCT01458522|Secondary|Percentage of Subjects Who Require a Rebolus of the Initial Antiepileptic Drugs (AED) to Control Nonconvulsive Seizures (NCS) in the LCM vs fPHT Arms.|The percentage of subjects who require a rebolus of the initial antiepileptic drug (AED) to control nonconvulsive seizures (NCS) in the LCM vs fPHT arms.|24 hours|Data are reported for the percentage of participants who require a rebolus of the initial antiepileptic drugs (AED) to control nonconvulsive seizures (NCS) in the LCM vs fPHT arms in the period prior to crossover.|||Participants|||Count of Participants
2674031|NCT01458522|Primary|Percentage of Subjects Who Experience no Nonconvulsive Seizures (NCS) for 24 Hours Following Treatment With LCM vs. fPHT, as Measured by Continuous Electroencephalography (cEEG) Monitoring.|Percentage of subjects who experience no nonconvulsive seizures (NCS) for 24 hours (after the 2-hour observation-only period) following treatment with LCM vs. fPHT, as measured by continuous electroencephalography (cEEG) monitoring with blinded review.|24 hours|Data are reported for the percentage of participants without a nonconvulsive seizure event in the period prior to crossover.|||Participants|||Count of Participants
2674032|NCT01458392|Secondary|Disease Control Rate|Disease control rate will be estimated as the proportion of patients evaluable for response who meet the criteria for complete response, partial response, or stable disease.|Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years.|The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population. 40 received at least one dose of study drug in either the 0.6 mg/kg or 1.2 mg/kg dose groups and had at least one on-treatment tumor assessment.|||percentage of participants||95% Confidence Interval|Number
2674033|NCT01458392|Secondary|Overall Survival (OS)|OS is calculated as the number of months from date of the first dose to the date of death. The last patient treated will be followed for overall survival for 1 year following treatment initiation.|Survival captured until death or at a minimum 1 year from first dose of dalantercept.|The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population.|||weeks||95% Confidence Interval|Median
2674034|NCT01458392|Secondary|Progression Free Survival (PFS)|PFS is defined as the date of the first dose to the first observation of disease progression (according to RECIST v.1.1) or death due to any cause. Progression is defined using RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years.|The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population.|||weeks||95% Confidence Interval|Median
2674035|NCT01458392|Secondary|Dalantercept Serum Concentration After Single and Multiple Doses|Pharmacokinetic samples were collected pre- and post- dose on Days: 1, 8, 15, 22, 29, and 43. Reported below is Cmax (cycle 1).|Up to 43 days from initiation of treatment.|The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol was amended to incorporate weight-based dosing for the remainder of the study population. 2 patients in the 0.6-mg/kg and 6 in the 1.2-mg/kg cohort had less than 2 measurable serum dalantercept concentrations and were excluded from PK analysis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2674036|NCT01458392|Secondary|Dalantercept Serum Concentration After Single and Multiple Doses|Pharmacokinetic samples were collected pre- and post- dose on Days: 1, 8, 15, 22, 29, and 43. Reported below is AUC0-t (cycle 1).|Up to 43 days from initiation of treatment.|The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol was amended to incorporate weight-based dosing for the remainder of the study population. 2 patients in the 0.6-mg/kg and 6 in the 1.2-mg/kg cohort had less than 2 measurable serum dalantercept concentrations and were excluded from PK analysis.|||ng*day/mL||Geometric Coefficient of Variation|Geometric Mean
2674037|NCT01458392|Secondary|Safety and Tolerability|Number of participants with at least one adverse event as a measure of safety and tolerability.|Adverse events captured from first dose of dalantercept through 30 days after last dose of dalantercept.||||participants|||Number
2674078|NCT01458171|Secondary|Number of Days of Hospitalization Due to Infections.|Median number of days of hospitalization due to infections.|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.|||days||Full Range|Median
2674038|NCT01458392|Primary|Objective Response Rate (ORR)|ORR is defined as the proportion of patients who met criteria for complete response or partial response. Patients were evaluable for ORR if they had at least one measurable lesion at baseline and at least one disease assessment after baseline. RECIST version 1.1 was used to evaluate efficacy. In addition, patients who developed clinical or radiological progression of disease prior to the scheduled tumor assessment were also considered evaluable for response. The response rate was estimated as the proportion of patients evaluable for response who meet the criteria for complete (CR) and partial response (PR). Per RECIST v1.1 for target lesions and assessed by MRI: complete response (CR), disappearance of all target lesions; partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR + PR.|Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years.|The two patients at the 80 mg, fixed-dose level were excluded from the efficacy analysis as the protocol had been amended to incorporate weight-based dosing for the remainder of the study population. 40 received at least one dose of study drug in either the 0.6 mg/kg or 1.2 mg/kg dose groups and had at least one on-treatment tumor assessment.|||participants||95% Confidence Interval|Number
2674039|NCT01458366|Secondary|Overall Safety and Tolerability of the Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide|"To define safety and tolerability of the combination of ofatumumab, bendamustine, carboplatin and etoposide as measured by the number of dose modifications made to Bendamustine..~Determined through dose modifications for bendamustine according to patient's toxicity levels:~Initial 120 mg/m2 dose decreased to 90 mg/m2~Initial 90 mg/m2 dose decreased to 70 mg/m2~Initial 70 mg/m2 dose decreased to 50 mg/m2~Initial 50 mg/m2 dose decreased to Withdrawn from study"|After each cycle (after approximately 3 days, 25 days, and 50 days)|one subject withdrew voluntarily and was not analyzed. As no dose modifications were needed during the study, results of analysis are provided based on the overall patients enrolled to the study.|||dose modifications|||Number
2674040|NCT01458366|Secondary|Overall Proportion of Patients Who Are Able to Undergo Stem Cell Transplant (SCT)|To determine the proportion of patients who are able to undergo stem cell transplant among transplant-eligible patients. Patients can receive SCT after Cycle 2.|At 2 years after completion of treatment|one subject withdrew voluntarily and was not analyzed. patients from both Phase I and Phase II were analyzed cumulatively for the purpose of analyzing the patients who received a transplant|||Participants|||Count of Participants
2674041|NCT01458366|Secondary|Total Overall Survival for Transplant vs Non-transplant|1 and 2 year overall survival for those who received Stem Cell Transplant (SCT) versus those who did not receive SCT|At 1 and 2 years after completion of treatment; year 2 reported|One patient withdrew and was not included in the analysis. For the purpose of this analysis, patients in both phases were combined into two groups based on whether or not the patient received a transplant.|||months||95% Confidence Interval|Median
2674042|NCT01458366|Secondary|Overall Progression-Free Survival|To determine 1 and 2 year progression-free survival [Cheson 2007] CR= complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy PR= >/= 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no increase in size of other nodes, liver or spleen;|At 1 and 2 years after completion of treatment; year 2 reported|Patients who achieved a complete or partial response. median progression free survival was not achieved in patients undergoing transplant. This population is patients who received the Maximum Tolerated Dose in both Phase I and Phase II. One patient withdrew and was not included in the analysis.|||months||95% Confidence Interval|Median
2674043|NCT01458366|Secondary|Overall Complete Response (CR) and Partial Response (PR) Rate|"Based on the revised response criteria for malignant lymphoma [Cheson 2007]~CR= complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy PR= >/= 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no increase in size of other nodes, liver or spleen;"|CT and PET scans after Cycle 2 (approximately 25 days) and 3-8 weeks post-treatment|one subject withdrew voluntarily and was not analyzed. The patients enrolled into Phase I portion were combined into one analysis group to compare the two phases of the study.|||Participants|||Count of Participants
2674044|NCT01458366|Secondary|Phase I: Overall Frequency of Response|"To determine the overall frequency of response--overall response will include all subjects with complete response (CR) and partial response (PR). Based on the revised response criteria for malignant lymphoma [Cheson 2007]~CR= complete disappearance of all detectable clinical evidence of disease and disease related symptoms if present before therapy PR= >/= 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses; no increase in size of other nodes, liver or spleen;"|CT and PET scans after Cycle 2 (approximately 25 days) and 3-8 weeks post-treatment|For the Phase 1 analysis, participants who received doses of Bendamustine below the MTD were combined for the statistical analysis.|||Participants|||Count of Participants
2674045|NCT01458366|Primary|Overall Frequency of Response With Combination of Bendamustine, Ofatumumab, Carboplatin, and Etoposide at Maximum Tolerated Dose (MTD)|To determine the overall frequency of response with combination bendamustine, ofatumumab, carboplatin, and etoposide for refractory or relapsed aggressive B-cell lymphomas. Overall response is determined as cumulative Complete Response (CR) and Partial Response (PR).|At 25 days and 3-8 weeks post-treatment|Patients who received MTD in phase 1 and the phase 2 patients were evaluated in combined analysis.|||Participants|||Count of Participants
2674046|NCT01458366|Primary|Phase I: Maximum-Tolerated Dose of Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide (BOCE)|To determine the maximum-tolerated dose of bendamustine in combination with ofatumumab, carboplatin and etoposide for patients with refractory or relapsed aggressive B cell lymphomas. Toxicity levels will be assessed after every cycle until a dose-limiting toxicity (DLT) is found. Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria (CTCAE version 4.0). DLT will be defined as any grade 4 infection, or grade >/= 3 non-hematologic toxicity that persists for 7 days or more.|Baseline through 50 days|Patients enrolled on the Phase 1 portion of the study|||mg/m^2|||Number
2674047|NCT01458288|Secondary|Circulating CD34+ Cell Count in Peripheral Blood|Calculate the median total CD34+ cell counts across all leukapheresis sessions following TG 0054 administration alone and in combination with G-CSF mobilization in order to evaluate the pharmacodynamics (PD) of TG-0054 by determining circulating CD34+ cell counts in peripheral blood.|pre-dose(-2 to 0 h),2, 4 and 6 hr after dosing.||||cells/kg||Full Range|Median
2674049|NCT01458288|Primary|Number of Patients Achieving the CD34+ Hematopoietic Stem Cell (HSC) Mobilization Target of ≧2.5×1000000 Cells/kg|"Patients were all with multiple myeloma (MM), Non-Hodgkin lymphoma (NHL) or Hodgkin disease (HD).~Number of patients who mobilized the targeted total number of CD34+ cells within a maximum of 4 leukapheresis sessions in study arm 1 and arm 3. Patients in arm 1 followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1. Patients in arm 3 followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8."|1 week||||participants|||Number
2674050|NCT01458275|Secondary|Percentage of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Weeks 0 - 3||||Percentage of participants|||Number
2674051|NCT01458275|Secondary|Number of Subjects Experiencing Treatment-emergent Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Weeks 0 - 3||||participants|||Number
2674052|NCT01458275|Secondary|Treatment-emergent AEs Causing Study Medication Discontinuation||Weeks 0 - 3||||participants|||Number
2674053|NCT01458275|Secondary|Percentage of Subjects Experiencing Treatment-emergent AEs|Treatment-Emergent Adverse Events Occurring in ≥ 2% of Subjects in Any Treatment Group (ITT Population)|Weeks 0 - 3||||Percentage of participants|||Number
2674054|NCT01458275|Secondary|Number of Subjects Experiencing Treatment-emergent AEs|Treatment-Emergent Adverse Events Occurring in ≥ 2% of Subjects in Any Treatment Group (ITT Population)|Weeks 0 - 3||||participants|||Number
2674055|NCT01458275|Secondary|Time to Maximal Effect in the AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period|The time to maximal effect, defined as the number of days until the first treatment day on which the estimated difference between ciclesonide nasal aerosol and placebo was at least 90% of the largest estimated difference, was based on the analyses of change from baseline in the average of AM and PM rTNSS scores for each day. The time to achieve at least 90% of these estimated differences is presented.|Weeks 0 - 2||||Days|||Number
2674056|NCT01458275|Secondary|Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Ocular Symptom Scores (iTOSS) Over the 2-week Double-blind Treatment Period.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TOSS symptom scores assess symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement"|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment|||units on a scale||Standard Error|Least Squares Mean
2674057|NCT01458275|Secondary|Change From Baseline in Average Daily Subject Reported AM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions assessed in the AM. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe in the AM. Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment|||units on a scale||Standard Error|Least Squares Mean
2674058|NCT01458275|Secondary|Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the Double-blind Treatment Period.|PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains.|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment|||units on a scale||Standard Error|Least Squares Mean
2674059|NCT01458275|Secondary|Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Ocular Symptom Scores (rTOSS) Over the 2-week Double-blind Treatment Period.|"TOSS is the sum of individual ocular symptoms of itching, tearing, and redness. Subjects assess each individual symptoms on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, TOSS ranges from 0-9 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TOSS symptom scores assess symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement."|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment|||units on a scale||Standard Error|Least Squares Mean
2674060|NCT01458275|Secondary|Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Over the 2-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 - 2|n = number of ITT subjects in treatment group with completed assessment|||units on a scale||Standard Error|Least Squares Mean
2674079|NCT01458171|Secondary|Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections.|Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections.|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.|||days||Full Range|Median
2674061|NCT01458275|Primary|Change From Baseline in Average Daily Subject Reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Over the 2-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the two week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 - 2|n = number of ITT subjects in treatmentgroup with completed assessment|||units on a scale||Standard Error|Least Squares Mean
2674062|NCT01458249|Secondary|Best Overall Response (BOR)|The best overall response categories (CR, PR, SD [including non-CR/non-PD], PD, not evaluable [NE], and unknown [UNK]) were derived based on time point tumor responses during the study as assessed by the IRC as well as the investigator. Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. BOR of SD must have occurred at least 35 days (at least 5 weeks) after the first dose of study drug. If a participant had a BOR of non-CR/non-PD, the participant's BOR was grouped with the SD category.|Date of CR, PR, SD to PD or death of any cause, whichever is first, or date of study cutoff (14 Nov 2014), or up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).|||Percentage of participants|||Number
2674063|NCT01458249|Secondary|Durable Stable Disease (SD) Rate (dSDR)|Durable stable disease rate was defined as the percentage of participants who manifested durable stable disease (the duration of stable disease for greater than or equal to eleven weeks) and was estimated based on the tumor response assessments performed according to RECIST v1.1. Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. A 2-sided 95% CI was calculated using the exact method of binomial distribution.|Date of dSD to date of PD or death, whichever is first, or date of study cutoff (24 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).|||Percentage of participants||95% Confidence Interval|Number
2674064|NCT01458249|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants who had a BOR of CR + PR + dSD (duration of SD greater than or equal to 11 weeks [77 days] after the first dose of study treatment). Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. For participants whose BOR was SD, the duration of SD was defined as the time from the date of the first dose of study treatment to the first documented PD or death, whichever occurred first (i.e., same definition of PFS). If the dSD was censored at a time less than 11 weeks, the participant was considered as not having a clinical benefit. A 95% CI was calculated using exact method of binomial distribution.|First dose of study treatment to the date of CR, PR, or dSD to date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).|||Percentage of participants||95% Confidence Interval|Number
2674065|NCT01458249|Secondary|Disease Control Rate (DCR)|Disease control rate was defined as the percentage of participants who had BOR of CR + PR + SD. BOR of SD must have manifested at least five weeks (35 days) after the first dose of study treatment. Tumor assessment was performed at Week 6 and Week 12 after the start of treatment, and every six weeks thereafter. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started. A 95% CI was calculated using exact method of binomial distribution.|Date of CR, PR, or SD to date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).|||Percentage of participants||95% Confidence Interval|Number
2674066|NCT01458249|Secondary|Objective Response Rate (ORR)|Objective response rate was defined as the percentage of participants who had a best overall rate (BOR) of CR or PR. Tumor assessment was performed at Week 6 and Week 12 after the start of study treatment, and every six weeks thereafter. The BOR of CR and PR in this study required confirmation by a subsequent assessment of response at least four weeks (28 days) later. CR and PR were determined by the Investigator and IRC using RECIST v1.1 for target lesions assessed by MRI/CT scans. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. A 95% CI was calculated using exact method of binomial distribution.|Date of CR or PR to the date of PD or death, whichever is first, or date of study cutoff (14 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).|||Percentage of participants||95% Confidence Interval|Number
2674080|NCT01458171|Secondary|Number of Infection Episodes (Serious and Non-serious)||24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.|||infection episodes|||Number
2674993|NCT01451398|Secondary|FPG Change From Baseline to Week 24|Efficacy as measured by mean change in fasting plasma glucose (FPG)|Baseline to Week 24|Full analysis set for subjects with data at both Baseline and at Week 24|||mg/dL||Standard Error|Least Squares Mean
2674067|NCT01458249|Secondary|Overall Survival (OS)|Overall survival was defined as the time from the date of treatment start to the date of death from any cause. Participants were followed for survival every twelve weeks after PD. In the absence of confirmation of death, participants were censored either at the date that the participant was last known alive or the date of study cutoff, whichever came earlier. Participants censored before database cutoff included those who were lost to follow up and who withdrew consent. A 95% CI was calculated using Kaplan-Meier estimate and Greenwood Formula. A generalized Brookmeyer and Crowley method is used to construct a log-log-transformed 95% CI.|Cycle 1 (Day 1) to death, or date of study cutoff, (14 Nov 2014), up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).|||Months||95% Confidence Interval|Median
2674068|NCT01458249|Secondary|Progression-Free Survival (PFS)|Progression-free survival was defined as the time from the date of treatment start to the first documented date of event (disease progression or death from any cause, whichever occurred first). PFS was assessed every six weeks (until disease progression was confirmed, or sooner, if clinically indicated) and was based on Investigator and Independent Review Committee (IRC) assessments according to RECIST v1.1. Disease progression was measured using computed tomography (CT) or magnetic resonance imaging (MRI) on targeted tumors and defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions. A 95% CI was calculated using Kaplan-Meier estimate and Greenwood Formula. A generalized Brookmeyer and Crowley method was used to construct a log-log-transformed 95% CI.|Cycle 1 (Day 1) to progressive disease (PD) or death, or date of study cutoff (14 Nov 2014) up to 3 years|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).|||Months||95% Confidence Interval|Median
2674069|NCT01458249|Primary|Progression-free Rate at 12 Weeks (PFR12wks)|The PFR at 12 weeks was the percentage of participants with progression-free survival (success) measured as a binary variable based on the tumor response assessed at Week 12 after the start of study treatment. Participants were considered a success if one radiological evaluation performed at least Week 12 after start of therapy indicated stable disease (SD), or complete response (CR) or partial response (PR), as defined according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1); all other cases were considered as failures (including disease progression or death before the Week 12 evaluation, or had unknown disease status at Week 12). If new anticancer treatments were started before the Week 12 evaluation, participants were considered failures. A 2-sided 90% confidence interval (CI) was calculated using the exact method of binomial distribution.|Week 12|Full analysis set included all participants who received at least one dose of study drug. This was the primary analysis set for all efficacy evaluations. Arm 1 included all participants with ADI or LMS. Arm 2 included all participants with soft tissue sarcomas other than ADI or LMS (OTH).|||Percentage of participants||90% Confidence Interval|Number
2674070|NCT01458210|Primary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Ortho-Cyclen - Ethinyl Estradiol (EE)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable ethinyl estradiol (EE) concentration data.|||hours||Full Range|Median
2674071|NCT01458210|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ortho-Cyclen - Ethinyl Estradiol (EE)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable ethinyl estradiol (EE) concentration data.|||picograms per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2674072|NCT01458210|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Ethinyl Estradiol (EE)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable ethinyl estradiol (EE) concentration data.|||picograms*hour/milliliter (pg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2674073|NCT01458210|Primary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Ortho-Cyclen - Norelgestromin (NGMN)||Day 21 Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable norelgestromin (NGMN) concentration data.|||hours||Full Range|Median
2674074|NCT01458210|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ortho-Cyclen - Norelgestromin (NGMN)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable norelgestromin (NGMN) concentration data.|||picograms per milliliter (pg/mL)||Geometric Coefficient of Variation|Geometric Mean
2674075|NCT01458210|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) at Steady State of Ortho-Cyclen - Norelgestromin (NGMN)||Day 21 during Periods 1 and 2: Pre-dose and up to 24 hours post-dose|Participants who received at least 1 dose of study drug with evaluable norelgestromin (NGMN) concentration data.|||picograms*hour/milliliter (pg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2674076|NCT01458171|Other Pre-specified|Rate of Infection Episodes (Serious and Non-serious)|The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the FAS population and the PPS population and adjusted to 365 days.|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.|||infection episodes per subject year|Participants||Number
2674077|NCT01458171|Secondary|Duration of Use of Antibiotics for Infection Prophylaxis and Treatment|Median number of days of use of antibiotics for infection prophylaxis and/or treatment|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.|||days||Full Range|Median
2674994|NCT01451398|Secondary|Proportion of Responders Achieving HbA1c <= 6.5%|Efficacy as measured in proportion of subjects achieving HbA1c < or = to 6.5% at Week 24|Week 24|Full analysis set for subjects with available data at Week 24|||percentage of participants|||Number
2674081|NCT01458171|Secondary|Annualized Rate of Clinically Documented Serious Bacterial Infections (SBIs)|SBIs are defined as bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess. The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the FAS and PPS and adjusted to 365 days.|24 weeks|The FAS comprised all subjects receiving at least 1 IgPro20 infusion. The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.|||SBIs per subject year|Participants||Number
2674082|NCT01458171|Secondary|IgG Trough Level|Serum IgG trough levels at the completion visit compared to the baseline visit of the follow-up study. IgG trough levels at baseline, at the completion visit, and the change from baseline to the completion visit are shown|24 weeks|The Full Analysis Set (FAS) comprised all subjects receiving at least 1 IgPro20 infusion. The Per Protocol Set (PPS) comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.|||g/L||Standard Deviation|Mean
2674083|NCT01458171|Secondary|Percentage of Infusions With Subject-assessed Tolerability of at Least 'Good'|"Subjects assessed their overall perception of local tolerability at the infusion site throughout the study in the subject diary within a time window of 24 h to 72 h after the end of the latest infusion by assessing it as very good, good, fair, or poor. The reported percentage represents the percentage of subjects with local tolerability assessments of very good or good at any given study infusion."|24 to 72 hours after infusion|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.|||percentage of infusions|||Number
2674084|NCT01458171|Secondary|Number of Subjects With Newly Developing or Worsening AEs|Number of subjects with AEs, overall and classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]).|24 weeks|The AT set comprised all subjects receiving at least 1 IgPro20 infusion.|||participants|||Number
2674085|NCT01458171|Secondary|Overall Rate of AEs Per Infusion|The rate was calculated by counting all newly developed or worsened AEs during the treatment period in all subjects and dividing the total number of AEs by the total number of IgPro20 infusions administered. In addition, individual AEs were classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]). The AE rates per infusion by severity and causal relationship to study medication were calculated by dividing the number of AEs in each category by the total number of IgPro20 infusions.|24 weeks|The AT set comprised all subjects receiving at least 1 IgPro20 infusion.|||AEs per infusion|Participants||Number
2674086|NCT01458171|Primary|Median of the Individual Subject's Rate of Adverse Events (AEs) Per Infusion|The rate was calculated by counting all newly developed or worsened AEs within a subject and dividing by the total number of IgPro20 infusions administered to this subject. Subsequently, the median of these individual AE rates per infusion was calculated. AE rates were classified (i) by severity (mild, moderate, severe) and (ii) by causal relationship to study medication (not related or unlikely related; at least possibly related [i.e., possibly related, probably related, or related]).|24 weeks|The All Treated (AT) set comprised all subjects receiving at least 1 IgPro20 infusion.|||AEs per infusion||Full Range|Median
2674087|NCT01458132|Secondary|Number of Participants With Serious Adverse Event (SAE) and Adverse Event (AE)|An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|Upto 17 months|All Subject Population.|||Participants|||Count of Participants
2674088|NCT01458132|Primary|Number of Participants With Occurrence of Seizure|In the registry study from start to the end of follow-up, the number of participants who experienced seizure were reported. This was done to evaluate to test the time-efficiency and cost-efficiency for a long term, non-interventional study.|Up to 17 months|All Subject Population, defined as all participants, who consented to participate in the registry study.|||Participants|||Count of Participants
2674089|NCT01458119|Secondary|Annualized Rate Of Change In The Estimated Glomerular Filtration Rate (eGFR)|"The annualized rate of change of the eGFR was assessed per participant by the slope of the simple linear regression between the observed values and the assessment times. It was calculated by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (eGFR [CKD-EPI]) and the Modification of Diet in Renal Disease (MDRD) equation (eGFR [MDRD]). The equations are as follows:~eGFR [MDRD] = 175 * (Serum Creatinine)^-1.154 * (Age)^-0.203 * 1.212 (if black or African American) * 0.742 (if female); eGFR [CKD-EPI] = 141 * min(serum creatinine/kappa,1)^alpha * max(serum creatinine/kappa, 1)^-1.209 * 0.993^age * 1.1018(if female) * 1.159(if black or African American), where kappa is 0.7 for females and 0.9 for males, alpha is -0.329 for females and -0.411 for males, min is minimum of serum creatinine/kappa or 1, and max is the maximum of serum creatinine/kappa or 1. The number of participants with at least a Baseline and a post-Baseline value are presented."|Baseline, Every 6 m until the End of Study (42 m)|"ITT-Amenable Population: All participants who received at least 1 dose of study drug. Participants with mutant forms of α-Galactosidase (Gal) A determined to be amenable to migalastat based on the GLP-HEK assay are referred to as “with amenable mutations. Number of participants analyzed are those with at least a Baseline and a post-Baseline value."|||milliliters/minute/1.73 meters^2||95% Confidence Interval|Mean
2674126|NCT01457950|Other Pre-specified|Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab at Month 12|Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 12 was summarized.|Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.|||Participants|||Number
2674090|NCT01458119|Primary|Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)|An adverse event (AE) was defined as any untoward medical occurrence in a participant administered migalastat that did not necessarily have a causal relationship with the treatment. Each AE was recorded at the time of reporting; visits typically occurred every 6 months. A TEAE was defined as an AE starting on or after the first study drug administration date. Serious AEs were life-threatening or resulted in death, persistent or significant incapacitation, inpatient or prolonged hospitalization, or a congenital anomaly. The criteria for AE severity were: Mild: minimal discomfort, does not interfere with normal everyday activities; Moderate: sufficiently discomforting, interferes with normal everyday activities; Severe: prevents normal everyday activities. The number of participants experiencing TEAEs is presented for those who received migalastat treatment. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline to End of Follow-up (30 days after the end of this 42-month study), with AE reporting occurring at each study visit, which occurred once every 6 months.|Safety Population: All participants who received at least 1 dose of study drug after they enrolled into this open-label extension study.|||participants|||Number
2674091|NCT01458106|Secondary|Percentage of AUCinf Extrapolated From the Last Data Point to Infinity (%AUCext; Two-stage Chromogenic Assay)|Percentage of AUCinf extrapolated from the last data point to infinity for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||percentage of AUCinf||95% Confidence Interval|Geometric Mean
2674092|NCT01458106|Secondary|Percentage of AUCinf Extrapolated From the Last Data Point to Infinity (%AUCext; One-stage aPTT Clotting Assay)|Percentage of AUCinf extrapolated from the last data point to infinity for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||percentage of AUCinf||95% Confidence Interval|Geometric Mean
2674093|NCT01458106|Secondary|Area Under the Curve to Infinity (AUCinf; Two-stage Chromogenic Assay)|Dose normalized area under the FVIII activity-time curve to infinity for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU*h/dL||95% Confidence Interval|Geometric Mean
2674094|NCT01458106|Secondary|Area Under the Curve to Infinity (AUCinf; One-stage aPTT Clotting Assay)|Dose normalized area under the FVIII activity-time curve to infinity for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU*h/dL||95% Confidence Interval|Geometric Mean
2674095|NCT01458106|Secondary|Area Under the Curve to the Last Measurable Timepoint (AUClast; Two-stage Chromogenic Assay)|Dose-normalized area under the FVIII activity-time curve to the last measurable timepoint for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU*h/dL||95% Confidence Interval|Geometric Mean
2674096|NCT01458106|Secondary|Area Under the Curve to the Last Measurable Timepoint (AUClast; One-stage aPTT Clotting Assay)|Dose-normalized area under the FVIII activity-time curve to the last measurable timepoint for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU*h/dL||95% Confidence Interval|Geometric Mean
2674154|NCT01457950|Secondary|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
2674097|NCT01458106|Secondary|Volume at Terminal Phase (Vz; Two-stage Chromogenic Assay)|Volume of distribution estimated from the terminal phase for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||mL/kg||95% Confidence Interval|Geometric Mean
2674098|NCT01458106|Secondary|Volume at Terminal Phase (Vz; One-stage aPTT Clotting Assay)|Volume of distribution estimated from the terminal phase for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||mL/kg||95% Confidence Interval|Geometric Mean
2674099|NCT01458106|Secondary|Lambda Z (Two-stage Chromogenic Assay)|First order rate constant associated with the terminal portion of the curve (lambda z) for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||1/hours||95% Confidence Interval|Geometric Mean
2674100|NCT01458106|Secondary|Lambda Z (One-stage aPTT Clotting Assay)|First order rate constant associated with the terminal portion of the curve (lambda z) for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||1/hours||95% Confidence Interval|Geometric Mean
2674101|NCT01458106|Secondary|Time at Maximum Activity (Tmax; Two-stage Chromogenic Assay)|Time at which maximum activity (Cmax) is observed for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||hours||95% Confidence Interval|Geometric Mean
2674102|NCT01458106|Secondary|Time at Maximum Activity (Tmax; One-stage aPTT Clotting Assay)|Time at which maximum activity (Cmax) is observed for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||hours||95% Confidence Interval|Geometric Mean
2674103|NCT01458106|Secondary|Incremental Recovery (IR; Two-stage Chromogenic Assay)|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
2674104|NCT01458106|Secondary|Incremental Recovery (IR; One-stage aPTT Clotting Assay)|The rise in FVIII activity in IU/dL per unit dose administered in IU/kg for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
2674155|NCT01457950|Secondary|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed. .|||Internationational Units(IU)/Liter (L)||Standard Deviation|Mean
2674105|NCT01458106|Secondary|Mean Residence Time (MRT; Two-stage Chromogenic Assay)|The average time that a drug molecule is present in the systemic circulation for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||hours||95% Confidence Interval|Geometric Mean
2674106|NCT01458106|Secondary|Mean Residence Time (MRT; One-stage aPTT Clotting Assay)|The average time that a drug molecule is present in the systemic circulation for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||hours||95% Confidence Interval|Geometric Mean
2674107|NCT01458106|Secondary|Dose Normalized Area Under the Curve (DNAUC; Two-stage Chromogenic Assay)|Dose normalized area under the FVIII activity-time curve for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
2674108|NCT01458106|Secondary|Dose Normalized Area Under the Curve (DNAUC; One-stage aPTT Clotting Assay)|Dose normalized area under the FVIII activity-time curve for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
2674109|NCT01458106|Secondary|Volume at Steady State (Vss; Two-stage Chromogenic Assay)|Volume of distribution at steady state for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||mL/kg||95% Confidence Interval|Geometric Mean
2674110|NCT01458106|Secondary|Volume at Steady State (Vss; One-stage aPTT Clotting Assay)|Volume of distribution at steady state for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||mL/kg||95% Confidence Interval|Geometric Mean
2674111|NCT01458106|Secondary|Clearance (CL; Two-stage Chromogenic Assay)|Rate at which the body removes the drug, measured as the volume of the plasma cleared of drug per unit time per unit weight for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||mL/h/kg||95% Confidence Interval|Geometric Mean
2674112|NCT01458106|Secondary|Clearance (CL; One-stage aPTT Clotting Assay)|Rate at which the body removes the drug, measured as the volume of the plasma cleared of drug per unit time per unit weight for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||mL/h/kg||95% Confidence Interval|Geometric Mean
2674156|NCT01457950|Secondary|Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||Grams (G)/Liter (L)||Standard Deviation|Mean
2674113|NCT01458106|Secondary|Elimination Half Life (t1/2; Two-stage Chromogenic Assay)|Time required for the activity of the drug to reach half of its original value for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||hours||95% Confidence Interval|Geometric Mean
2674114|NCT01458106|Secondary|Elimination Half Life (t1/2; One-stage aPTT Clotting Assay)|Time required for the activity of the drug to reach half of its original value for participants in the PK subgroup. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||hours||95% Confidence Interval|Geometric Mean
2674115|NCT01458106|Secondary|Maximum Plasma Activity (Cmax; Two-stage Chromogenic Assay)|Maximum plasma activity during a dosing interval for participants in the PK subgroup. The values for Cmax were adjusted to the nominal dose of 50 IU/kg. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU/dL||95% Confidence Interval|Geometric Mean
2674116|NCT01458106|Secondary|Maximum Plasma Activity (Cmax; One-stage Activated Partial Thromboplastin Time [aPTT] Clotting Assay)|Maximum plasma activity during a dosing interval for participants in the PK subgroup. The values for Cmax were adjusted to the nominal dose of 50 IU/kg. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28 ±7 days prior to Day 1) Prestudy FVIII Dosing: predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours post-dose. Day 1 (rFVIIIFc Dosing): predose; 30 ±5 min, 3 hours ±30 min, 24 ±3 hours, 48 ±4 hours, 72 ±7 hours post-dose|PK Analysis Set: All participants in the PK subgroup with adequate PK data, defined as complete and evaluable PK samples through 72 hours after rFVIIIFc dosing. Complete means the availability of the 72-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU/dL||95% Confidence Interval|Geometric Mean
2674117|NCT01458106|Secondary|Total Dose Required for Resolution of a Bleeding Episode|The total dose required to resolve a bleeding episode per participant and per episode, based on the efficacy period. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. For 'Per bleeding episode' values, for each bleeding episode, the total dose is the sum of the doses (IU/kg) administered across all injections given to treat that bleeding episode. For 'Per participant' values, the total dose (IU/kg) used to resolve each bleed is averaged across all bleeding episodes per participant.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; number of participants and number of episodes were determined for participants who had complete information on the dose administered to treat a bleeding episode.|||IU/kg|Bleeding Episodes|Full Range|Median
2674118|NCT01458106|Secondary|Number of Injections Required for Resolution of a Bleeding Episode|The number of injections required to resolve a bleeding episode per participant and per episode, based on the efficacy period. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. All injections given from the initial sign of a bleed, until the last date/time within the bleed window are counted. The resolution of a bleed is defined as no sign of bleeding following injection for the bleed. For 'Per participant' values, the number of injections required to resolve each bleed is averaged across all bleeding episodes per participant.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; number of participants and number of episodes were determined for participants with at least 1 evaluable bleeding episode.|||injections|Bleeding Episodes|Inter-Quartile Range|Median
2674119|NCT01458106|Secondary|Number of Days From Last Treatment Injection to a Spontaneous Bleeding Episode|The number of days from the last prophylaxis injection to the onset of a new spontaneous bleeding episode, analyzed across all evaluable bleeding episodes per participant and per episode, based on the efficacy period. Evaluable bleeding episodes are those for which both a date and time are available for both the onset of the bleeding episode and the previous prophylactic injection. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. For 'Per participant' values, the number of days from the last prophylactic injection to a spontaneous bleeding episode is averaged across all evaluable spontaneous bleeding episodes per participant.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; number of participants and number of episodes were determined for participants with at least 1 evaluable spontaneous bleeding episode.|||days|Evaluable Spontaneous Bleeding Episodes|Inter-Quartile Range|Median
2674157|NCT01457950|Secondary|Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||Ratio||Standard Deviation|Mean
2674120|NCT01458106|Secondary|Annualized rFVIIIFc Consumption Per Participant|Consumption is calculated for the efficacy period. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. Annualized consumption = (total IU/kg of study treatment received during the efficacy period / total number of days during the efficacy period)*365.25. Consumption was calculated overall for all participants and for the last 3 months (91 days) on study, counted backwards from the end of the efficacy period, for participants with at least 24 weeks on study.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc. 'Overall' n=participants in the Full Analysis Set with evaluable data in the efficacy period; 'Last 3 Months on Study' n=participants in the Full Analysis Set with evaluable data and ≥ 24 weeks on study.|||IU/kg rFVIIIFc per participant per year||Standard Deviation|Mean
2674121|NCT01458106|Secondary|Physician's Global Assessment of the Participant's Response to His rFVIIIFc Regimen|Investigators assessed each participant's response to his rFVIIIFc regimen using a 4-point scale: excellent=bleeding episodes responded to ≤ the usual number of injections or ≤ the usual dose of rFVIIIFc or the rate of breakthrough bleeding during prophylaxis was ≤ that usually observed; effective=most bleeding episodes responded to the same number of injections and dose, but some required more injections or higher doses, or there was a minor increase in the rate of breakthrough bleeding; partially effective=bleeding episodes most often required more injections and/or higher doses than expected, or adequate breakthrough bleeding prevention during prophylaxis required more frequent injections and/or higher doses; ineffective=routine failure to control hemostasis, or hemostatic control required additional agents. Percentages are based on the total number of responses; multiple responses per participant are counted.|Up to Week 26 +/- 7 days|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; based on the number of responses.|||percentage of responses|Responses||Number
2674122|NCT01458106|Secondary|Participant Assessment of Response to Injections to Treat a Bleeding Episode|Participant's assessment (provided by the caregiver) of the response to the first rFVIIIFc injection for each bleeding episode. Percentages were based on the number of first injections for which a response was provided, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after a single injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within approximately 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|Up to Week 26 +/- 7 days|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc and had a bleeding episode; participants with a non-evaluable bleed are counted in the number of participants analyzed, but not the percentages.|||percent of 1st injections w/ a response|Injections||Number
2674123|NCT01458106|Secondary|Annualized Joint Bleeding Rate (Spontaneous)|Annualized bleeding rate for spontaneous joint bleed=(number of bleeding episodes meeting those criteria during the efficacy period/total number of days during the efficacy period)*365.25. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken more than 72 hours after the preceding one was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last inject|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; based on the number of participants whose efficacy period is of at least 1 day in duration.|||bleeding episodes per participant per yr||Inter-Quartile Range|Median
2674124|NCT01458106|Secondary|Annualized Bleeding Rate|Annualized bleeding rate = (number of bleeding episodes during the efficacy period / total number of days during the efficacy period)*365.25. The efficacy period begins with the first prophylactic dose of rFVIIIFc and ends with the last dose (for prophylaxis or a bleed). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. A bleeding episode started from the first sign of a bleed and ended no more than 72 hours after the last treatment for the bleed, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken more than 72 hours after the preceding one was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last injection.|Up to Week 26 +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFVIIIFc; based on the number of participants whose efficacy period was of at least 1 day in duration.|||bleeding episodes per participant per yr||Inter-Quartile Range|Median
2674125|NCT01458106|Primary|Occurrence of FVIII Inhibitor Development|An inhibitor test result ≥0.6 Bethesda units (BU)/mL, confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. Both tests were to be performed by the central laboratory using the Nijmegen-modified Bethesda Assay. Incidences were summarized for any positive inhibitor for participants with ≥50 EDs to rFVIIIFc. In addition, the incidence for all participants, regardless of their EDs to rFVIIIFc, was also summarized. An exact 95% CI for the proportion of participants with a confirmed inhibitor was calculated using the Clopper-Pearson exact method for a binomial proportion.|Up to Week 26 +/- 7 days, or up to 50 exposure days (EDs) if reached prior to Week 26|Safety Analysis Set: participants who received at least 1 dose of prestudy FVIII, or at least 1 dose of rFVIIIFc; n=number of participants with given number of exposure days who had a valid inhibitor test.|||percentage of participants||95% Confidence Interval|Number
2674180|NCT01457846|Secondary|Overall Survival : Number of Patients Who Had Died at DCO (Data Cut Off)||Tumour size assessed at week 8 (±1 week) and then every 8 weeks (±1 week)|This secondary analysis included factors for treatment and FGFR2 FISH score (4/5 versus 6) and is based on the Full analysis set (all treated patients).|||Patients|||Number
2674127|NCT01457950|Other Pre-specified|Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 12|Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (<50 or >120 Bits Per Minutes [bpm]), Systolic Blood Pressure (>170 Millimeters of Mercury [mmHg] or <100 mmHg) and Heart rate (>110 mmHg or <50 mmHg) are summarized. Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.|||Participants|||Number
2674128|NCT01457950|Other Pre-specified|Change From Baseline in Red Cell Distribution Width at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.|||percentage (%) of mean RBC volume||Standard Deviation|Mean
2674129|NCT01457950|Other Pre-specified|Change From Baseline in Red Blood Cell Count at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
2674130|NCT01457950|Other Pre-specified|Change From Baseline in Mean Corpuscle Hemoglobin at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.|||Picograms (PG)/cell)||Standard Deviation|Mean
2674131|NCT01457950|Other Pre-specified|Change From Baseline in Hematocrit at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Ony those participants with a value at Baseline and Month 12 were analyzed.|||Proportion of RBCs in blood||Standard Deviation|Mean
2674132|NCT01457950|Other Pre-specified|Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.|||Millimole/Liter (MMOL/L)||Standard Deviation|Mean
2674133|NCT01457950|Other Pre-specified|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.|||Micromole/liter (UMOL/L)||Standard Deviation|Mean
2674134|NCT01457950|Other Pre-specified|Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Segmented Neutrophils, Platelet Count and White Blood Cell Count at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
2674135|NCT01457950|Other Pre-specified|Change From Baseline in Alkaline Phosphatase, Alanine Amino Transferase, Creatinine Kinase, Gamma Glutamyl Transferase and Lactate Dehydrogenase at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.|||Internationational Units(IU)/Liter (L)||Standard Deviation|Mean
2674136|NCT01457950|Other Pre-specified|Change From Baseline in Albumin, Hemoglobin, Mean Corpuscle Hemoglobin and Total Protein at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.|||Grams (G)/Liter (L)||Standard Deviation|Mean
2674137|NCT01457950|Other Pre-specified|Change From Baseline in Albumin/Globulin Ratio and Blood Urea Nitrogen (BUN)/Creatinine Ratio at Month 12|Change from Baseline was calculated as the Month 12 value minus the Baseline value.|Baseline and Month 12|ITT-OL Population: Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT-OL population.|||Ratio||Standard Deviation|Mean
2674138|NCT01457950|Other Pre-specified|Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE) During the Open-Label Extension Phase|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Month 6 to Month 12|ITT-OL Population|||Participants|||Number
2674139|NCT01457950|Other Pre-specified|Median Percent Change From Month 6 in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Placebo|Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by measure at Month 6 * 100.|Month 6 and Month 12|ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.|||Percent change||Inter-Quartile Range|Median
2674140|NCT01457950|Other Pre-specified|Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Month 12 for Participants Previously Randomized to Denosumab|Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline - measure at Baseline) divided by measure at Baseline * 100.|Baseline and Month 12|ITT-OL Population. Ony those participants with a value at Baseline and Month 12 were analyzed.|||Percent change||Inter-Quartile Range|Median
2674141|NCT01457950|Other Pre-specified|Mean Percent Change From Month 6 in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Placebo|Mean percent change from Month 6 in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by the measure at Month 6 * 100.|Month 6 and Month 12|ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.|||Percent change||Standard Error|Mean
2674142|NCT01457950|Other Pre-specified|Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 12 for Participants Previously Randomized to Denosumab|Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 - measure at Baseline) divided by the measure at Baseline * 100.|Baseline and Month 12|ITT-OL Population. Ony those participants with a value at Baseline and Month 12 were analyzed.|||Percent change||Standard Error|Mean
2674143|NCT01457950|Other Pre-specified|Mean Percent Change From Month 6 in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Placebo|Mean percent change from Month 6 in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Month 6 BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Month 6=(measure at Month 12 - measure at Month 6) divided by the measure at Month 6 * 100.|Month 6 and Month 12|ITT-OL Population. Ony those participants with a value at Month 6 and Month 12 were analyzed.|||Percent change||Standard Error|Mean
2674144|NCT01457950|Other Pre-specified|Mean Percent Change From Baseline in Lumbar Spine BMD at Month 12 for Participants Previously Randomized to Denosumab|Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 12 - measure at Baseline) divided by the measure at Baseline * 100.|Baseline and Month 12|Intent-to-Treat Open-Label (ITT-OL) Population: all participants from the ITT population in the Double-Blind Phase who continued into the Open-Label Extension Phase of the study and received denosumab at Month 6. Ony those participants with a value at Baseline and Month 12 were analyzed.|||Percent change||Standard Error|Mean
2674145|NCT01457950|Secondary|Number of Participants With Positive and Negative Results for Anti-body Formation to Denosumab|Number of participants with positive and negative results for both neutralizing antibodies to denosumab, and for binding antibodies to denosumab at Month 6 was summarized.|Month 6|ITT Population. Only participants at the specified time points were analyzed.|||Participants|||Number
2674146|NCT01457950|Secondary|Number of Participants With a Change From Baseline in Vital Signs of Potential Clinical Concern at Month 6|Vital Sign Changes from Baseline of potential clinical concern for Diastolic Blood Pressure (<50 or >120 Bits Per Minutes [bpm]), Systolic Blood Pressure (>170 Millimeters of Mercury [mmHg] or <100 mmHg) and Heart rate (>110 mmHg or <50 mmHg) are summarized. Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||Participants|||Number
2674147|NCT01457950|Secondary|Change From Baseline in Red Cell Distribution Width at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||percentage (%) of mean RBC volume||Standard Deviation|Mean
2674148|NCT01457950|Secondary|Change From Baseline in Red Blood Cell Count at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
2674149|NCT01457950|Secondary|Change From Baseline in Mean Corpuscular Volume at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||Femtoliters (FL)||Standard Deviation|Mean
2674150|NCT01457950|Secondary|Change From Baseline in Mean Corpuscle Hemoglobin at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||Picograms (PG)/cell||Standard Deviation|Mean
2674151|NCT01457950|Secondary|Change From Baseline in Hematocrit at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||Proportion of RBCs in blood||Standard Deviation|Mean
2674152|NCT01457950|Secondary|Change From Baseline in Calcium Corrected, Calcium, Chloride, Glucose, Potassium, Magnesium, Sodium, Phosphorus Inorganic, Triglycerides, Urea/BUN, Very Low Density Lipoproteins (VLDL) Cholesterol Calculation at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||Millimole/Liter (MMOL/L)||Standard Deviation|Mean
2674153|NCT01457950|Secondary|Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine and Uric Acid at Month 6|Change from Baseline was calculated as the Month 6 value minus the Baseline value.|Baseline and Month 6|ITT Population. Only participants at the specified time points were analyzed.|||Micromole/liter (UMOL/L)||Standard Deviation|Mean
2674158|NCT01457950|Secondary|Number of Participants With Any Adverse Events (AE) or Any Serious Adverse Events (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From Baseline up to Month 6|Intent-to-Treat (ITT) Population: all participants who received one dose of study medication.|||Participants|||Number
2674159|NCT01457950|Secondary|Median Percent Change From Baseline in s-CTX and s-P1NP Biomarkers at Months 1, 3 and 6|Serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTx) I and Serum procollagen type I N propeptide s (s-PINP) are used as serum biomarkers of bone resorption in the assessment of osteoporosis and is measured in units of micrograms (µg)/liters (L). Percentage change from Baseline=(measure at post-Baseline - measure at Baseline) divided by measure at Baseline * 100.|Baseline, Months 1, 3 and 6|ITTE Population. Only participants at the specified time points were analyzed.|||Percent change||Inter-Quartile Range|Median
2674160|NCT01457950|Secondary|Mean Percent Change From Baseline in Total Hip, Femoral Neck, and Trochanter BMD at Month 1 and Month 6|Mean percent change from Baseline in total hip, femoral neck, and trochanter bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covarience (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1/6 - measure at Baseline) divided by the measure at Baseline * 100.|Baseline, Month 1 and Month 6|ITTE Population|||Percent change||Standard Error|Mean
2674161|NCT01457950|Secondary|Mean Percent Change From Baseline in Lumbar Spine BMD at Month 1|Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 1 - measure at Baseline) divided by the measure at Baseline * 100.|Baseline and Month 1|ITTE Population|||Percent change||Standard Error|Mean
2674162|NCT01457950|Primary|Mean Percent Change From Baseline in Lumbar Spine BMD at Month 6|Mean percent change from Baseline in lumbar spine bone mineral density (BMD) was measured by the dual-energy x-ray absorptiometry (DXA) scanner. Analyses were performed using the Analysis of Covariance (ANCOVA) model adjusting for treatment and Baseline BMD for the skeletal site under consideration as a continuous covariate. Percentage change from Baseline=(measure at Month 6 - measure at Baseline) divided by the measure at Baseline * 100.|Baseline and Month 6|Intent-to-Treat Efficacy (ITTE) Population: all participants who received one dose of study medication, and had a Baseline measure and at least one post-Baseline efficacy measure during the Double-Blind Treatment Phase.|||Percent change||Standard Error|Mean
2674163|NCT01457924|Secondary|Cumulative Volume of New T1 Hypointense Lesions at Week 24 and Week 48|Lesion volume is a measure of lesion size determined by a MRI brain scan. Baseline is defined as the participant's last available assessment prior to initiation of IP. Change from Baseline was calculated by subtracting the Baseline value from the post-Baseline value. The AES dataset was used which included all evaluable on-treatment MRI scans for each par.|Baseline, Week 24 and Week 48|ITT Population. Only those par. available at the specified time points were analyzed.|||mm^3||Standard Deviation|Mean
2674164|NCT01457924|Secondary|Cumulative Number of New T1 Hypointense Lesions at Week 24 and Week 48|The cumulative number of new T1 hypointense lesions at week 24 were analyzed from screen based on MRI brain scans at Weeks 4, 8, 12, 16, 20 and 24. The AES dataset was used which included all evaluable on-treatment MRI scans for each par.|Week 24 and Week 48|ITT Population. Only those par. available at the specified time points were analyzed.|||Number of lesions||Standard Deviation|Mean
2674165|NCT01457924|Secondary|Total Volume of New and/or Newly Enlarging T2 Lesions at Week 12|Lesion volume is a measure of lesion size determined by a MRI brain scan. T2 lesions, are indicative of brain myelin content.The cumulative volume of new and/or newly enlarging T2 lesions at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8, and 12. The AES dataset was used which included all evaluable on-treatment MRI scans for each par.|Week 12|ITT Population. Only those par. available at the specified time points were analyzed.|||mm^3||Standard Deviation|Mean
2674166|NCT01457924|Secondary|Cumulative Number of New and Newly Enlarging GdE T2 Lesions at Week 12|The cumulative number of new and newly enlarging GdE T2 lesions (NET2L) at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. The endpoint was analyzed using a generalized linear model assuming an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of NET2L per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed.|Week 12|ITT Population. Only those par. available at the specified time points were analyzed.|||Cumulative number of lesions||Standard Deviation|Mean
2674167|NCT01457924|Secondary|Total Volume of All (New and Persistent) GdE Brain Lesions on T1-weighted MRI at Week 12|Lesion volume is a measure of lesion size determined by a MRI brain scan. The cumulative volume of all (new and persistent) GdE T1 lesions at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. The endpoint was analyzed using a generalized linear model assuming an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative volume of lesions was fitted as an offset. Estimates of the rate of cumulative volume of all (new and persistent) GdE T1 lesions per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed.|Week 12|ITT Population. Only those par. available at the specified time points were analyzed.|||mm^3||Standard Deviation|Mean
2674995|NCT01451398|Secondary|Proportion of Responders Achieving HbA1c <= 7.0%|Efficacy as measured in proportion of subjects achieving HbA1c < or = to 7.0%|Week 24|Full analysis set for subjects with available data at Week 24|||percentage of participants|||Number
2674168|NCT01457924|Secondary|Total Volume of New GdE Brain Lesions on T1-weighted MRI at Week 12|Lesion volume is a measure of lesion size determined by a MRI brain scan. The cumulative volume of new GdE T1 lesions at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. Anticipating an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative volume of lesions was fitted as an offset. Estimates of the rate of cumulative volume of new GdE T1 lesions per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed.|Week 12|ITT Population. Only those par. available at the specified time points were analyzed.|||Cubic millimeter (mm^3)||Standard Deviation|Mean
2674169|NCT01457924|Secondary|Cumulative Number of All (New Plus Persistent) GdE Brain Lesions on T1-weighted MRI at Week 12|The cumulative number of all (new plus persistent) GdE T1 lesion at Week 12 were analyzed from screen based on MRI brain scans at Weeks 4, 8 and 12. Anticipating an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of all (new plus persistent) GdE T1 lesions per scan at Week 12 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed.|Week 12|ITT Population. Only those par. available at the specified time points were analyzed.|||Cumulative number of lesions||Standard Deviation|Mean
2674170|NCT01457924|Secondary|Cumulative Number of Persistent GdE Brain Lesions on T1-weighted MRI at Week 12|The cumulative number of persistent GdE T1 lesions at Week 12 were analyzed from screen based on MRI scans at Weeks 4, 8, and 12. The AES dataset was used which included all evaluable on-treatment MRI scans for each par. analyzed.|Week 12|ITT Population. Only those par. available at the specified time points were analyzed.|||Number of lesions per scan||Standard Deviation|Mean
2674171|NCT01457924|Secondary|Change From Baseline in Brain Volume at Week 24 and Week 48|Brain volume is a measure of brain size determined by a MRI scan. Baseline is defined as the par. last available assessment prior to initiation of the IP (i.e. Screening). Change from Baseline was calculated by subtracting the Baseline value from the post-Baseline value.|Baseline (Week 0), Week 24 and Week 48|ITT Population. Only those par. available at the specified time points were analyzed.|||Cubic centimeters||Standard Deviation|Mean
2674172|NCT01457924|Secondary|Cumulative Number of New GdE T1 Lesions at Week 24|The cumulative number of new GdE T1 lesion at Week 24 were analyzed from screen based on MRI brain scans at Weeks 4, 8, 12, 16, 20 and 24. Anticipating an underlying negative binomial distribution with a log-link function, adjusted for treatment and presence/absence of GdE lesions on the Screening MRI. Treatment group was fitted as a categorical variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of new GdE T1 lesions per scan at Week 24 were determined from the model. The AES dataset was used which included all evaluable on-treatment MRI scans for each participant analyzed.|Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Cumulative number of lesions||Standard Deviation|Mean
2674173|NCT01457924|Primary|Cumulative Number of New Gadolinium-enhancing (GdE) T1 Lesions at Week 12|The cumulative number of new GdE T1 lesion at Week 12 were analyzed from screening based on magnetic resonance imaging (MRI) brain scans at Weeks 4, 8, and 12. The outcome measure was analyzed using an Emax model adjusting for the presence/absence of GdE lesions on the Screening MRI and assuming the number of new lesions followed a negative binomial distribution. Dose was fitted as a continuous variable. The number of scans contributing to the cumulative number of lesions was fitted as an offset. Estimates of the rate of cumulative number of new GdE lesions per scan at Week 12 were determined from the model. The all evaluable scans (AES) dataset was used which included all evaluable on-treatment MRI scans for each participant analysed.|Week 12|Intent-to-Treat (ITT) Population comprised of all randomized par. who received at least one dose of IP and who had at least one post screen MRI assessment. Only those par. available at the specified time points were analyzed. Please see footnote of statistical analysis 1 for discrepancy in analysis population Week 24 and 48.|||Cumulative number of lesions||Standard Deviation|Mean
2674174|NCT01457885|Secondary|Incidence of Relapse||2 years|75 patients were enrolled. One patient was not treated. 3 patients were pediatric and therefore left off of this analysis.|||percentage of patients||95% Confidence Interval|Number
2674175|NCT01457885|Secondary|The Percentage of Patients Alive at 1 Year|Overall survival was calculated following transplant using a CloBu4 conditioning regimen for patients with non-remission AML|1 year|75 patients were enrolled. Only 74 patients were treated. 3 of the 74 patients were pediatric and were therefore left off of analysis.|||percentage of patients||95% Confidence Interval|Number
2674176|NCT01457885|Primary|Cumulative Incidence of Non Relapse Mortality (NRM)|Percentage of patients passed without relapse/recurrence at 1 year.|1 year|75 patients were enrolled. Only 74 patients were treated. 3 of the 74 patients were pediatric and were therefore left off of analysis.|||percentage of patients||95% Confidence Interval|Number
2674177|NCT01457846|Secondary|Percentage of Patients Without Progressive Disease at 8 Weeks|PD = A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diamters|Week 8 (±1 week)|Full analysis set - all treated patients|||Percentage of patients|||Number
2674178|NCT01457846|Secondary|Percentage Change From Baseline at Week 8 in Target Lesion Size|A negative change denotes a reduction in target lesion size. Percentage change from baseline in tumour size at 8 weeks in target lesion size.|Baseline, Week 8 (±1 week)|Full analysis set - all treated patients with at least one post baseline RECIST target lesion assessment scan|||Percentage change||Standard Deviation|Mean
2674179|NCT01457846|Secondary|Objective Response Rate|ORR=Percentage of patients with at least one visit response of CR (complete response) or PR (partial response) that is confirmed at least 4 weeks later; CR:disappearance of target lesions and no new lesions; PR is at least 30% decrease in sum of diameters of lesions taking as a reference the smallest sum since treatment started.|Week 8 (±1 week) and then every 8 weeks (±1 week)|The analysis included factors for treatment and FGFR2 FISH score (4/5 versus 6) and is based on the Full analysis set (all treated patients).|||Patients (%)|||Number
2674182|NCT01457703|Secondary|Changes in Follicle Stimulating Hormone (FSH) (Aim 2)|Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.|Measured hourly and averaged over the 12 hour study visit|This study was divided into two aims, and only 12 obese and 11 normal weight women completed the study procedures for Aim 2 that allowed measure of FSH.|||IU/L||Standard Deviation|Mean
2674183|NCT01457703|Secondary|Changes in Follicle Stimulating Hormone (FSH) (Aim 1)|Follicle-stimulating hormone was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.|Measured hourly and averaged over the 12 hour study visit|This study was divided into two aims, and only 10 obese and 10 normal weight women completed the study procedures for Aim 1 that allowed measure of FSH.|||IU/L||Inter-Quartile Range|Mean
2674184|NCT01457703|Primary|Changes in Pregnanediol Glucuronide (PdG) (Aim 2)|Pregnanediol glucuronide (PdG) was collected daily over the course of one menstrual cycle and averaged.|Averaged over the length of menstrual cycle|This study was divided into two aims, and only 12 obese and 10 normal weight women completed the urine collection study procedures for Aim 2 that allowed measure of PdG.|||ug/cycle||Standard Deviation|Mean
2674185|NCT01457703|Primary|Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 2)|Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.|Measured hourly and averaged over the 12 hour study visit|This study was divided into two aims, and only 12 obese and 11 normal weight women completed the study procedures for Aim 2 that allowed measure of LH pulse amplitude.|||IU/L||Standard Deviation|Mean
2674186|NCT01457703|Primary|Changes in Luteinizing Hormone (LH) Pulse Amplitude (Aim 1)|Luteinizing Hormone (LH) Pulse Amplitude was measured hourly during the 12 hour study visit, and was compared between the obese and normal weight groups.|Measured hourly and averaged over the 12 hour study visit|This study was divided into two aims, and 10 obese and 10 normal weight women completed the study procedures and contributed data for analyses related to Aim 1.|||IU/L||Inter-Quartile Range|Mean
2674187|NCT01457573|Secondary|Change in Urinary Growth Factor to Creatinine Ratio (GF/Cr) From Baseline Compared to Month 1/Week4 and Month 2/Week 8.|Assessing the change from baseline to Month 1/Week 4 and Month 2/Week 8, of the urinary growth factor (GF) to creatinine ratio in men, which may be potential biomarker for overactive bladder, based on published articles. Measuring the ratio at baseline compared to Month 1 and Month 2 may provide insight into how lower urinary tract symptoms in men progresses.|change from baseline score to Mo.1/Wk4 and Mo.2/Wk8 scores||||ratio||Standard Deviation|Mean
2674188|NCT01457573|Secondary|Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.1/Wk4 and Mo.2/Wk8|Urine sample tested for urinary Nerve Growth Factor (uNGF as measured in pg/mL), a small secreted protein in the bladder that supports bladder function regulation, at baseline (pre-dose) compared to Month 1/Week 4 and Month 2/Week 8, post dosing with tamsulosin and solifenacin.|Change from baseline to Mo.1/Wk4 and Mo.2/Wk8||||pg/ml||Standard Deviation|Mean
2674189|NCT01457573|Secondary|Change in ICIQ LUTS QoL -International Consultation on Incontinence Modular Questionnaire LUTS Quality of Life for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12|Change in the International Consultation on Incontinence Modular Questionnaire on lower urinary tract symptoms quality of life survey for men, self administered, compared to Month 1, Month 2, and Month 3, after exposure to tamsulosin and solifenacin. The survey scoring is zero to 182, with 182 being the most bothersome and 0 to 1 being the least bothersome.|Change from baseline to months 1, 2 and 3||||units on a scale||Standard Deviation|Mean
2674190|NCT01457573|Secondary|Change in ICIQ-MLUTS - International Consultation on Incontinence Modular Questionnaire for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12|Measuring change in the International Consultation on Incontinence Modular Questionnaire for male lower urinary tract symptoms through a self administered survey at baseline compared to Month 1, Month 2, and Month 3, after exposure to tamsulosin and solifenacin. The survey score is a zero to 182 range with 182 being the most bothersome and zero to one being the least bothersome.|Change from baseline to months 1, 2 and 3||||units on a scale||Standard Deviation|Mean
2674191|NCT01457573|Secondary|Change in PBC-Patient Perception of Bladder Condition at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12|Change in the Perception of Bladder through a self administered survey at baseline compared to Month 1, Month 2, and Month 3, following exposure to tamsulosin and solifenacin. The survey score measures from zero to 6, with 6 being the most bothersome bladder symptoms and 0 to 1 being the least bothersome.|Change from baseline to months 1, 2 and 3||||units on a scale||Standard Deviation|Mean
2674192|NCT01457573|Secondary|Change in PPUS-Patient Perception of Urinary Urgency Survey Score at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12|The Patient Perception of Urinary Urgency self administered survey score has a maximum score 4, zero to four, for how severe a patient describes their urinary voiding frequency. Four is the most bothersome score, 0 or 1 is the least bothersome. Pre-dose / baseline score is compared at Month 1, Month 2, and Month 3, after dosing with tamsulosin and solifenacin.|Change from baseline to months 1, 2 and 3||||units on a scale||Standard Deviation|Mean
2674193|NCT01457573|Secondary|Change in IPSS-International Prostate Score Scale at Baseline Compared to Post Dose Survey at Month 1, 2, and Month 3/Week12.|The survey, IPSS-International Prostate Score Scale, survey responses measured 0-35, is collected at baseline compared to post dose survey response at Month 1, Month 2, and Month 3/Week12 post-dose. The lower the score is indicative of less or fewer urinary symptoms while 35 is consistent with more bothersome symptoms.|Change from baseline to months 1, 2 and 3||||units on a scale||Standard Deviation|Mean
2674194|NCT01457573|Secondary|Change in Maximum Urinary Flow Rate (ml/s) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12|Urination flow rate (measured in milliliters per second) at baseline (pre-dose), and Month 1, Month 2, and Month 3/Week 12 pose-dosing with tamsulosin and solifenacin. An average maximum urinary flow rate in males is 21 ml/sec aged 14-45 years-old and 12 ml/sec in males aged 46-65 years-old.|Change from baseline to months 1, 2 and 3||||ml/s||Standard Deviation|Mean
2674195|NCT01457573|Secondary|Change in Post Void Residual (mL) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12|Urine sample tested for urinary post void residual (measured in mL) at baseline (pre-dose), Month 1 and Month 2and week 12/Month 3 post-dose, post dose w/tamsulosin and solifenacin.|Change from baseline to months 1, 2 and 3||||ml||Standard Deviation|Mean
2674196|NCT01457573|Primary|Change From Baseline in Urinary Growth Factor to Creatinine Ratio (GF/Cr)|The urinary growth factor (GF) to creatinine ratio may be potential biomarker for overactive bladder, based on published articles. Measuring the ratio at baseline and Month 3, comparing the difference after treatment with tamsulosin and solifenacin which may provide insight into how lower urinary tract symptoms in men progresses.|change from baseline score to Month 3||||ratio||Standard Deviation|Mean
2674197|NCT01457573|Primary|Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.3/Wk12|Urine sample tested for urinary Nerve Growth Factor (uNGF as measured in pg/mL), a small secreted protein in the bladder that supports bladder function regulation, at baseline (pre-dose) and week 12/Month 3 post-dose, after using daily tamsulosin and solifenacin.|Change from baseline to week 12 (3 months)||||pg/ml||Standard Deviation|Mean
2674198|NCT01457521|Primary|11-point Visual Analog Scale for Pain|Participant pain was assessed using an 11-point Visual Analog Scale for Pain. Scores ranged from 0 (no pain) to 10 (worst pain possible)|1-2 weeks||||units on a scale||Standard Deviation|Mean
2674199|NCT01457430|Secondary|Percent Change in VAS Scores|Baseline, 4 hours VAS scale ranges from 0-100 with 0 being the lowest severity and 100 being the highest severity|Percent Change in VAS Score from Baseline to 4 Hours||||percent change||Inter-Quartile Range|Median
2674200|NCT01457430|Primary|Time to Complete or Near Complete Resolution From Onset of Symptoms|Time of onset of HAE attack, time icatibant was administered, and time to complete relief of symptoms were recorded in minutes. Time to complete relief of symptoms was defined as time from onset of symptoms to complete or near complete resolution as reported by the patient.|Time to complete or near complete resolution of symptoms as reported by the patient, an expected average of 8-10 hours||||minutes||Inter-Quartile Range|Median
2674201|NCT01457417|Primary|Progression Free Survival (PFS) in Patients With Relapsed or Refractory Non-small Cell Lung Cancer (NSCLC)|For Part B only. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. PFS was defined as the time from the date of signed informed consent to the first date of objectively determined progressive disease (Progression is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and International Multiple Myeloma Working Group (IMWG)) or death from any cause. For patients who were still alive at the time of analysis (ie, data cut-off date) and without evidence of tumor progression, PFS was censored at the date of the most recent objective progression-free observation.|Time from the date of signed informed consent to the first date of objectively determined progressive disease or death from any cause|Patients with advanced NSCLC receiving the study drug at 300 mg every 2 weeks in Part B|||months||95% Confidence Interval|Median
2674202|NCT01457417|Secondary|Objective Response Rate (ORR) in Patients With Relapsed or Refractory Non-small Cell Lung Cancer (NSCLC)|FAS : For both Parts A and B. Objective response rate is defined as the number of patients with overall best response of complete response (CR) or partial response (PR)|Part A: Every 2 months; Part B: after 1 month and every two cycles thereafter|FAS : NSCLC - All patients with NSCLC who received at least one dose of study treatment during Part A or Part B of the study. Two patients in treatment group 300 mg Q2W did not have assessments performed after Baseline.|||participants||95% Confidence Interval|Number
2674203|NCT01457417|Secondary|Objective Response Rate (ORR) in Oncologic Patients Who Are Refractory or Intolerant to Standard/Approved Therapies|For both Parts A and B. Objective response rate is defined as the number of patients with overall best response of complete response (CR) or partial response (PR)|Part A: Every 2 months; Part B: after 1 month and every two cycles thereafter|All patients with NSCLC who received at least one dose of study treatment during Part A or Part B of the study. One Patients from the 300 mg QW treatment group, and two patients from 300 mg Q2W treatment group did not have assessments performed after Baseline.|||Participants||95% Confidence Interval|Number
2674204|NCT01457417|Secondary|Overall Survival (OS) in Patients With Relapsed or Refractory NSCLC|For Part B only. OS was defined as the time from the date of signed informed consent to the date of death from any cause. For patients who were still alive as of the data cut-off date, OS time was censored on the date of the patient's last contact (last contact for patients in post-discontinuation was the last date of contact in long-term follow-up eCRF).|Time from the date of signed informed consent to the date of death from any cause|For patients who are still alive as of the data cut-off date, OS time will be censored on the date of the patient’s last contact (last contact for patients in post-discontinuation = last Date of Contact in Long Term Follow-up eCRF).|||Months||95% Confidence Interval|Median
2674205|NCT01457417|Secondary|Progression Free Survival (PFS) in Patients Who Are Refractory or Intolerant to Standard/Approved Therapies|For both Parts A and B. PFS was defined as the time from the date of signed informed consent to the first date of objectively determined progressive disease (Progression is defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and International Multiple Myeloma Working Group (IMWG)) or death from any cause. For patients who were still alive at the time of analysis (i.e, data cut-off date) and without evidence of tumor progression, PFS was censored at the date of the most recent objective progression-free observation.|Time from the date of signed informed consent to the first date of objectively determined progressive disease or death from any cause|All patients who received at least one dose of study treatment during Part A or Part B of the study.|||Months||95% Confidence Interval|Median
2674206|NCT01457417|Secondary|Pharmacokinetic: Maximum Plasma Concentration (Cmax) of DKN-01|Peak DKN-01 serum concentration (Cmax) after the fourth infusion on Cycle 1 Weeks 1 and 4, for both Parts A and B. Cycle 1 day 22 included only QW dosing groups.|Cycle 1 Day 22 (Fourth dose for QW groups)|All patients who received at least one dose of study treatment during Part A of the study.|||ng/mL||Standard Deviation|Mean
2674207|NCT01457417|Secondary|Pharmacokinetic: Maximum Plasma Concentration (Cmax) of DKN-01|Peak DKN-01 serum concentration (Cmax) after the first and fourth infusion on Cycle 1 Weeks 1 and 4, for both Parts A and B. Cycle 1 Day 1 included once per week (QW) dosing groups and every two weeks (Q2W) dosing groups.|Cycle 1 Day 1 (first dose, all groups)|All patients who received at least one dose of study treatment during Part A or Part B of the study.|||ng/mL||Standard Deviation|Mean
2674208|NCT01457417|Secondary|Pharmacokinetics: Area Under the Concentration - Time Curve (AUC) of DKN-01|Area under the DKN-01 serum concentration-time profile curve during the dosing interval (AUC0-tau) after the first and fourth infusion for both Parts A and B. Cycle 1 day 22 included only QW dosing groups.|Cycle 1 Day 22 (Fourth Dose for QW)|All patients who received at least one dose of study treatment during Part A study.|||hr*ng/mL||Standard Deviation|Mean
2674209|NCT01457417|Secondary|Pharmacokinetics: Area Under the Concentration - Time Curve (AUC) of DKN-01|Area under the DKN-01 serum concentration-time profile curve during the dosing interval (AUC0-tau) after the first and fourth infusion for both Parts A and B. Cycle 1 Day 1 included once per week (QW) dosing groups and every two weeks (Q2W) dosing groups.|Cycle 1 Day 1 (first dose, all groups)|All patients who received at least one dose of study treatment during Part A or Part B of the study.|||hr*ng/mL||Standard Deviation|Mean
2674210|NCT01457417|Primary|Summary of Patients With Adverse Events (AE)|Number of patients who had Adverse Events (AE) including treatment related treatment emergent adverse events (TEAE), Common Toxicity Criteria for Adverse Effects (CTCAE), and Serious Adverse Events (SAE) for both Parts A and B. Severity was coded to NCI CTCAE version 4.02. For maximum severity and relationship, patients were counted only once in the most severe or most related category.|Baseline to study completion (approximately 3 months)|Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study.|||Patients|||Number
2674211|NCT01457417|Primary|Summary of Total Adverse Events (AE)|Total Adverse Events (AE), total treatment emergent adverse events (TEAE), total Serious Adverse Events (SAE), and total dose-limiting toxicity (DLT) for both Parts A and B.|Baseline to study completion (approximately 3 months)|Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study.|||Events|||Number
2674212|NCT01457352|Secondary|Severity of Spasticity Assessed by Subject Global Impression Severity Scale|"The subject was asked Overall, how would you rate the severity of your spasticity over the past 24 hours? The 7-point scale for Subject's global impression of severity assessment is as follows: minimum score of 1 = normal, no spasticity maximum score of 7 (worst outcome)= worst spasticity imaginable"|Week 22|Intent to treat population: SPARC0921, N=147 and Placebo0921, N=146|||percentage of subjects|||Number
2674213|NCT01457352|Primary|Treatment Failure Rate|"Percentage of subjects who had treatment failure Clinical Global Impression of Change of ≥ 5 and at least one movement with ≥ 1 unit increase in modified Ashworth score from baseline.~The modified Ashworth scale is a 6-point scale as follows: Minimum score of 0 (better outcome) = no increase in tone Maximum score of 4 (worst outcome) = affected part(s) rigid inflexion or extension.~The clinician (other than the one performing the Modified Ashworth Scale assessment) rated his/her overall (global) impression of change in spasticity using the 7-point scale shown below: Minimum score of 1 (better outcome) = very much improved Maximum score of 7 (very much worse) = very much worse"|Week 22|Intent to treat population: SPARC0921, N=147 and and Placebo, N=146|||percentage of subjects|||Number
2674214|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 250 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Arcsine proportion correct||Standard Error|Mean
2674215|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 200 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Arcsine proportion correct||Standard Error|Mean
2674216|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 150 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Arcsine proportion correct||Standard Error|Mean
2674217|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 100 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Arcsine proportion correct||Standard Error|Mean
2674218|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 70 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Arcsine proportion correct||Standard Error|Mean
2674219|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 50 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Arcsine proportion correct||Standard Error|Mean
2674220|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 250 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
2674221|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 200 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
2674222|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 150 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
2674223|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 100 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
2674224|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 70 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
2674225|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 50 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
2674226|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 250 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
2674227|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 200 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
2674228|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 150 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
2674229|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 100 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
2674230|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 70 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
2674231|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 50 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Log10 milliseconds||Standard Error|Mean
2674232|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 250 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Number of Errors||Standard Error|Mean
2674233|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 200 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Number of Errors||Standard Error|Mean
2674234|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 150 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Number of Errors||Standard Error|Mean
2674235|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 100 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Number of Errors||Standard Error|Mean
2674236|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 70 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Number of Errors||Standard Error|Mean
2674237|NCT01457339|Secondary|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 50 mg|This battery is a series of 4 computerized cognition tests (Groton Maze Learning Test, Detection Task, Identification Task, and One Card Learning Task) designed to measure reaction time, visual learning and reasoning, and problem solving. The entire battery takes approximately 12 minutes to complete. CogState scores are measured on a linear scale (no maximum score). The Groton Maze Learning Test measures total number of errors made in problem solving (lower score = better performance). The Detection Task is measured by speed of performance (lower score = better performance). The Identification Task is measured by speed of performance (lower score = better performance). One Card Learning Task measures the accuracy of performance (higher score = better performance).|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||Number of Errors||Standard Error|Mean
2674238|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 250 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674996|NCT01451398|Primary|Change From Baseline to Week 24 in HbA1c|Efficacy as measured by change in glycated hemoglobin (HbA1c) at Week 24|Baseline to Week 24|Full analysis set|||percentage of hemoglobin||Standard Error|Least Squares Mean
2674239|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 200 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674240|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 150 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674241|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 100 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674242|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 70 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674243|NCT01457339|Secondary|Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 50 mg|BAS scale has objective, subjective, and global impression components of akathisia (motor restlessness that manifests itself with an inability to sit still or remain motionless). Objective and subjective components are rated on a scale from 0 (normal/absence) to 3 (severe) and are summed yielding a total score of 0 to 9. Global impression is rated on a scale from 0 (absent) to 5 (severe) with a total score ranging from 0 to 5. Lower scores indicate reduced restlessness.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674244|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 250 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674245|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 200 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674246|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 150 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674247|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 100 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674248|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 70 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674249|NCT01457339|Secondary|Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 50 mg|SAS is a 10-item scale used to evaluate the presence and severity of extrapyramidal symptoms. The items are scored on a scale from 0 to 4 with item-specific definitions given for each point. Total scores range from 0 to 40. Lower scores indicate less impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674997|NCT01451372|Secondary|Frequency of Sensor Usage Per Month|Frequency of sensor usage per month during the study. This information is collected in a journal questionnaire|24 months|Journal questionnaires about sensor usage were collected from 61 out of 69 subjects|||number of sensor used per month||Standard Deviation|Mean
2674250|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 250 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674251|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 200 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674252|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 150 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674253|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 100 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674254|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 70 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674255|NCT01457339|Secondary|Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 50 mg|CDSS is a 9-item scale to evaluate depression in subjects who have schizophrenia rated from 0 (absence of symptoms) to 3 (severe symptoms) with a total score range of 0 to 27. Lower scores indicate less depression.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674256|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 250 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674257|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 200 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674258|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 150 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674259|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 100 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674260|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 70 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674261|NCT01457339|Secondary|Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 50 mg|The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674568|NCT01454583|Primary|Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)|Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 2 years, the difference divided by the baseline value, multiplied by 100|Baseline and 2 years|Patients with RR measurement at baseline and 2 years follow-up|||percent change||Standard Deviation|Mean
2674262|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 250 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674263|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 200 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674264|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 150 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674265|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 100 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674266|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 70 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674267|NCT01457339|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 50 mg|The PANSS is a validated measure that evaluates the presence, absence, and severity of 30 symptoms of schizophrenia including both positive and negative symptoms and general psychopathology. Each of the 30-items are rated on a scale of 1 (absent) to 7 (extreme) with a total scoring range of 30 to 210. Higher scores indicate more impairment.|Baseline and Day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||units on a scale||Standard Error|Mean
2674268|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 250 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng/ml||Standard Deviation|Mean
2674269|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 200 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng/ml||Standard Deviation|Mean
2674270|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 150 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng/ml||Standard Deviation|Mean
2674271|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 100 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng/ml||Standard Deviation|Mean
2674272|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 250 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||beats/min||Standard Deviation|Mean
2674273|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 200 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||beats/min||Standard Deviation|Mean
2674274|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 150 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||beats/min||Standard Deviation|Mean
2674275|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 100 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||beats/min||Standard Deviation|Mean
2674276|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 70 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||beats/min||Standard Deviation|Mean
2674277|NCT01457339|Primary|Change From Baseline in Pulse Rate at Day 5: 50 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||beats/min||Standard Deviation|Mean
2674278|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 250 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
2674279|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 200 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
2674280|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 150 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
2674281|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 100 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
2674282|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 70 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
2674283|NCT01457339|Primary|Change From Baseline in Diastolic Blood Pressure at Day 5: 50 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
2674284|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 250 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
2674285|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 200 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
2674286|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 150 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
2674287|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 70 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng/ml||Standard Deviation|Mean
2674288|NCT01457339|Secondary|Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 50 mg|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng/ml||Standard Deviation|Mean
2674289|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 250 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng*hr/ml||Standard Deviation|Mean
2674290|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 200 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng*hr/ml||Standard Deviation|Mean
2674291|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 150 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng*hr/ml||Standard Deviation|Mean
2674292|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 100 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng*hr/ml||Standard Deviation|Mean
2674293|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 70 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng*hr/ml||Standard Deviation|Mean
2674294|NCT01457339|Secondary|Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 50 mg|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Day 5 (12-hour sampling period post-dose)|Pharmacokinetic Set defined as all subjects in the Safety set who had evaluable concentration-time profiles for lisdexamfetamine and/or d-amphetamine.|||ng*hr/ml||Standard Deviation|Mean
2674295|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 100 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
2674296|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
2674297|NCT01457339|Primary|Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg|Blood pressure and pulse measurements were taken using an automated blood pressure monitoring device (ideally using the same device, the same arm and in the same position throughout the study). Measurements of vital signs were performed in triplicate (3 measurements) after the subject had been in a sitting position for at least 5 minutes. Each of the 3 triplicate readings were performed in succession, at least 1-2 minutes apart, with the cuff fully deflated between measurements. It was expected that the triplicate measurements be obtained within a 5-6 minute period.|Baseline and day 5|Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.|||mmHg||Standard Deviation|Mean
2674298|NCT01457196|Other Pre-specified|Progression Free Survival|To compare progression free survival ratios between cancer patients with active disease with reportable genetic variant who were treated based on variant and those who were not treated based on a variant|1 Year|||||||
2674299|NCT01457196|Other Pre-specified|Collect and Describe Clinical Data|To collect and describe clinical data including treatment outcomes after availability of results in patients|1 Year|||||||
2674300|NCT01457196|Primary|Progression Free Survival|Estimate Progression Free Survival (PFS) at 2 years in cancer patients with active disease with a reportable genetic variant and those without a reportable genetic variant|2 Year||||percentage of participants||95% Confidence Interval|Number
2674301|NCT01457196|Primary|Proportion of Patients With a Reportable Genetic Variant|To estimate the proportion of patients enrolled on the study who have undergone successful sequencing and have a reportable genetic variant identified|1 year||||proportion of participants||95% Confidence Interval|Number
2674302|NCT01457053|Primary|Myocardial Blood Flow|Evaluate the effects of ultrafiltration (UF) compared to intravenous diuretic therapy on myocardial blood flow (MBF) and coronary flow reserve (CFR), as assessed by positron emission tomography (PET), in patients with acutely decompensated heart failure (ADHF).|1 - 5 days|No data analyzed due to inadequate enrollment.||||||
2674303|NCT01457014|Secondary|Number of Arterial Oxygen Saturation Per Hour|Arterial Oxygen Saturation was compared among using no treatment, CPAP, Auto SV and Manual SV.|four full night Polysomnography (PSG's)||||times per hour||Standard Deviation|Mean
2674304|NCT01457014|Secondary|Percent Oxygen Saturation|Oxygen Saturation were compared among using no treatment, CPAP, Auto SV and Manual SV.|four full night Polysomnography (PSG's)||||percentage of oxygen saturation||Standard Deviation|Mean
2674305|NCT01457014|Primary|Number of Sleep Related Events Per Hour|The number of Apnea-Hypopnea Events, Central Apneas, Obstructive Apneas and Hypopneas were compared among no treatment, CPAP, Auto SV and Manual SV.|four full night Polysomnography (PSG's)|After the Diagnostic Polysomnography (PSG) each participant completed a night in each arm.|||events/hour||Standard Deviation|Mean
2674306|NCT01456962|Primary|CD4+ to CD8+ T Cell Ratio in Cervical Biopsies|Evaluation of cervical immune health in HIV-infected women on tenofovir (TDF) and emtricitabine (FTC) and either raltegravir or atazanavir. Cervical CD4+ to CD8+ T cell ratios will be measured at one time point from cervical biopsies. Higher ratios will be a measure of better cervical immune health. In addition, ratios will be compared to the concentration of the drug in the genital tract.|12 hours after the last medication dose||||Cervical CD4+:CD8+ T cell ratio||95% Confidence Interval|Geometric Mean
2674307|NCT01456949|Secondary|Chronic Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) at 1 and 2 Years|"Freedom from chronic treatment failure, defined as:~Documented atrial fibrillation lasting longer than 30 seconds (outside the 90 day blanking period) OR~Intervention for atrial fibrillation (except for repeat cryoablation during the 90 day blanking period)"|Annually, at 1 and 2 years|Enrolled subjects that met all inclusion and no exclusion criteria, and who underwent a study cryoablation procedure.|||Percentage of participants||95% Confidence Interval|Number
2674308|NCT01456949|Secondary|Chronic Safety: Percentage of Participants Free From Major Atrial Fibrillation Events (MAFE) at 1, 2 and 3 Years.|Freedom from Major Atrial Fibrillation Event (MAFE): A MAFE is a serious adverse event (SAE) which has not been categorized as a cryoablation procedure event.|Annually, through 3 years|Enrolled subjects that met all inclusion and no exclusion criteria, and who underwent a study cryoablation procedure.|||Percentage of participants||95% Confidence Interval|Number
2674309|NCT01456949|Primary|Safety: Percentage of Participants Experiencing Cryoablation Procedure Events (CPEs) Through 12 Months|Demonstrate safety (through 12 months) of Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the rate of subjects experiencing Cryoablation Procedure Events (CPEs) with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).|12 Months|Enrolled subjects that met all inclusion and no exclusion criteria, and who underwent a study cryoablation procedure.|||Percentage of participants||95% Confidence Interval|Number
2675496|NCT01445873|Secondary|Change From Baseline in Pulmonary Capillary Wedge Pressure|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and follow-up values.|||mm Hg||95% Confidence Interval|Mean
2674310|NCT01456949|Primary|Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) Through 36 Months|"Evaluated by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).~Chronic treatment failure is defined as:~Documented atrial fibrillation lasting longer than 30 seconds (outside the 90 day blanking period) OR~Intervention for atrial fibrillation (except for repeat cryoablation during the 90 day blanking period)"|Through 36 months|Enrolled subjects that met all inclusion and no exclusion criteria, and who underwent a study cryoablation procedure.|||Percentage of participants||95% Confidence Interval|Number
2674311|NCT01456936|Secondary|7‑Day Point Prevalence of Abstinence (Overall)|"A responder to this endpoint requires the answer no to both questions 3 and 6 on the nicotine use inventory at that specific visit.~NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?"|24 Weeks|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.|||percentage of participants|||Number
2674312|NCT01456936|Secondary|7‑Day Point Prevalence of Abstinence, Psychiatric History Cohort|"A responder to this endpoint requires the answer no to both questions 3 and 6 on the nicotine use inventory at that specific visit.~NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?"|24 Weeks|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.|||percentage of participants|||Number
2674313|NCT01456936|Secondary|7‑Day Point Prevalence of Abstinence, Non-psychiatric History Cohort|"A responder to this endpoint requires the answer no to both questions 3 and 6 on the nicotine use inventory at that specific visit.~NUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?"|24 Weeks|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.|||percentage of participants|||Number
2674314|NCT01456936|Secondary|CO-confirmed Continuous Abstinence From Week 9 Through Week 24 (Overall)|"A responder to this endpoint requires the answer no to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive)."|Week 9 through Week 24|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.|||percentage of participants|||Number
2674315|NCT01456936|Secondary|CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Psychiatric History Cohort|"A responder to this endpoint requires the answer no to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive)."|Week 9 through Week 24|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.|||percentage of participants|||Number
2674316|NCT01456936|Secondary|CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Non-psychiatric History Cohort|"A responder to this endpoint requires the answer no to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive)."|Week 9 through Week 24|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.|||percentage of participants|||Number
2674317|NCT01456936|Secondary|CO‑Confirmed Continuous Abstinence for Weeks 9 Through 12 (Overall)|"A responder to this endpoint requires the answer no to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive)."|Week 9 through Week 12|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.|||percentage of participants|||Number
2674318|NCT01456936|Secondary|CO‑Confirmed Continuous Abstinence for Weeks 9 Through 12, Psychiatric History Cohort|"A responder to this endpoint requires the answer no to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive)."|Week 9 through Week 12|The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.|||percentage of participants|||Number
2674319|NCT01456936|Secondary|CO‑Confirmed Continuous Abstinence for Weeks 9 Through 12, Non-psychiatric History Cohort|"A responder to this endpoint requires the answer no to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive)."|Week 9 through Week 12|The full analysis set was defined under the intent-to-treat (ITT) principle as all randomized participants (N=8144) and was used for all efficacy endpoints.|||percentage of participants|||Number
2674320|NCT01456936|Secondary|"Clinical Global Impression of Improvement (CGI‑I), No Change Rating by Visit"|"The CGI-I is a clinician rated instrument that measures change in participant's psychiatric condition (or lack thereof in the stratum without psychiatric disorders) on a 7 point scale ranging from 1 (very much improved) to 7 (very much worse), with 4 = no change. The ratings were applicable even to those without psychiatric diagnoses (eg, those with no psychiatric symptoms would be rated as normal, not at all ill on the CGI-S at baseline and assuming no psychiatric symptoms emerge during the trial, would be rated as no change on the CGI-I at follow-up visits). For those participants with a psychiatric diagnosis, the clinician should rate the severity of the mental illness with respect to the clinician's experience with the psychiatric population to which the participant belongs."|Baseline to Week 24|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||percentage of participants|||Number
2674352|NCT01456299|Primary|LMA Insertion Condition|The pre-determined effect-site concentration of remifentanil or normal saline was administered according to the patient's group.LMAs were size #3 for women and #4 for men.The conditions of the LMA insertion were graded on a three point scale using six variables (mouth opening, ease of LMA insertion, swallowing, coughing and gagging, head and body movements, laryngospasm). Each of these variables was rated as excellent, intermediate or poor.|at that time on LMA insertion only||||participants|||Number
2674321|NCT01456936|Secondary|Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C‑SSRS) - Overall|"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from wish to be dead to active suicidal ideation with specific plan and intent. Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides."|Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||participants with positive responses|||Number
2674322|NCT01456936|Secondary|Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C‑SSRS) - Psychiatric History Cohort|"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from wish to be dead to active suicidal ideation with specific plan and intent. Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides."|Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||participants with positive responses|||Number
2674323|NCT01456936|Secondary|Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C‑SSRS) - Non-psychiatric History Cohort|"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from wish to be dead to active suicidal ideation with specific plan and intent. Answers at screening are for lifetime history. Answers for all other visits are since last visit.The scale is also used to record any completed suicides."|Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||participants with positive responses|||Number
2674324|NCT01456936|Secondary|HADS Total Score (Overall)|The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.|Baseline to Week 24|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||Units on a scale||Standard Deviation|Mean
2674325|NCT01456936|Secondary|HADS Total Score, Psychiatric History Cohort|The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.|Baseline to Week 24|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||Units on a scale||Standard Deviation|Mean
2674326|NCT01456936|Secondary|Hospital Anxiety and Depression Scale (HADS) Total Score, Non-psychiatric History Cohort|The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.|Baseline to Week 24|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||Units on a scale||Standard Deviation|Mean
2674327|NCT01456936|Secondary|Occurrence of the Components of Severe-only NPS AE Endpoint (Overall)|"The NPS AE endpoint was the occurrence of at least 1 treatment-emergent severe AE of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least 1 treatment-emergent severe AE of agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint."|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||participants|||Number
2674328|NCT01456936|Secondary|Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Psychiatric History Cohort|"The safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint."|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||participants|||Number
2674353|NCT01456221|Other Pre-specified|Nutritional Status Through Waist Circumference|Nutritional status was determined by registering waist circumference in cm.|At baseline (at diagnosis), three months, throughout six months.|Of the participants analyzed at baseline and at month 3 (119 in omega 3 and an hypocaloric diet group and 126 Placebo group) only 80 and 82 participants respectively finished the study at month 6. The participants who did not finish the study, were because they did not want to take another blood sample at month 6.|||cm||Standard Deviation|Mean
2674329|NCT01456936|Secondary|Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Non-psychiatric History Cohort|"The safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint."|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||participants|||Number
2674330|NCT01456936|Secondary|Occurrence of Severe-only NPS AEs in the Primary Endpoint, by Cohort|"The primary safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint."|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||percentage of participants|||Number
2674331|NCT01456936|Secondary|Occurrence of the Components of NPS AE Primary Endpoint (Overall)|The NPS AE composite results (as previously described) are for the two cohorts combined and are presented below.|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||participants|||Number
2674332|NCT01456936|Secondary|Occurrence of the Components of the NPS AE Primary Endpoint, Psychiatric History Cohort|"The safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below."|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||participants|||Number
2674333|NCT01456936|Secondary|Occurrence of the Components of the NPS AE Primary Endpoint, Non-psychiatric History Cohort|"The safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below."|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||participants|||Number
2674334|NCT01456936|Primary|Estimated NPS AE Rate (%), by Cohort|"The primary safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Estimated NPS AE rate (%) was calculated based on least-squares means analysis."|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||percentage of participants||95% Confidence Interval|Least Squares Mean
2674335|NCT01456936|Primary|Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint|"The primary safety endpoint is the occurrence of at least one treatment emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent moderate or severe adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide."|Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.|The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.|||percentage of participants|||Number
2674336|NCT01456897|Secondary|Mean Clinical Global Impression - Global Improvement(CGI-I)|The efficacy of trial medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at Baseline prior to the first dose of study medication. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF)|Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation.|||units on a scale||Standard Deviation|Mean
2674337|NCT01456897|Secondary|Mean Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S)|"Severity of illness for each participant was rated using the CGI-S, which was the secondary efficacy endpoint. To perform this assessment, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF)|Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation.|||units on a scale||Standard Deviation|Mean
2674338|NCT01456897|Secondary|Mean Change From Baseline in PANSS Negative Subscale Score|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In PANSS negative subscale the severity was rated for the following 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF)|Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation.|||units on a scale||Standard Deviation|Mean
2674339|NCT01456897|Secondary|Mean Change From Baseline in PANSS Positive Subscale Score|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In PANSS positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF)|Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation.|||units on a scale||Standard Deviation|Mean
2674340|NCT01456897|Secondary|Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS consisted of 3 subscales with 30 symptom constructs (positive subscale (7): delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/perseckion, and hostility; negative subscale (7): blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and conversation flow, stereotyped thinking and general psychopathology subscale (16): somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Severity was rated on 7-point scale with scores 1 (absence) & 7 (extremely severe). The PANSS Total score ranged from 7 (best possible outcome) to 210 (worst possible outcome).|From Baseline up to 52 Weeks including Week24, Week52, and Last Visit(LOCF)|Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation.|||units on a scale||Standard Deviation|Mean
2674341|NCT01456897|Primary|Percentage of Participants With Adverse Events|A treatment-emergent adverse event (TEAE) is defined as an AE that started after start of investigational medicinal product (IMP) treatment.|From Baseline up to 52 Weeks|Safety sample included those participants who had treated IMP.|||Participants|||Count of Participants
2674342|NCT01456780|Primary|Corneal Fluorescein Staining Score|Corneal Fluorescein Staining is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of corneal epitheliopathy.|Week 4 Time Point||||units on a scale||Standard Deviation|Mean
2674343|NCT01456780|Primary|Symptom Assessment iN Dry Eye (SANDE) Severity Score|Questionnaire given to patients to assess the severity of dry eye symptoms. The questionnaire utilizes a 100 mm horizontal Visual Analogue Scale technique to quantify the severity of the patient's dry eye symptoms. Change is quantified from baseline to week 4. The range of the SANDE severity scale is 0-100, with minimum level of severity of dry eye symptoms and 100 being the maximum level of severity of dry eye symptoms.|Week 4 Time Point||||units on a scale||Standard Deviation|Mean
2674344|NCT01456780|Primary|Symptom Assessment iN Dry Eye (SANDE) Frequency Score|Questionnaire given to patients to assess the frequency of dry eye symptoms. The questionnaire utilizes a 100 mm horizontal Visual Analogue Scale technique to quantify the frequency of the patient's dry eye symptoms. Change is quantified from baseline to week 4. The range of the SANDE frequency scale is 0-100, with 0 being the minimum level of frequency of dry eye symptoms and 100 being the maximum level of frequency of dry eye symptoms.|Week 4 Time Point||||units on a scale||Standard Deviation|Mean
2674345|NCT01456780|Primary|Ocular Surface Disease Index|OSDI is a 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms.|Week 4 Time Point||||units on a scale||Standard Deviation|Mean
2674346|NCT01456494|Secondary|Self-reported Confidence With Inhaler Technique Versus Actual Technique|"For all patients, the investigators compared their baseline self-reported confidence using a 5-point Likert scale and whether they used their inhaler correctly. The investigators define having strong confidence as either Agree or Strongly Agree when responding to I know how to use my inhaler correctly. The investigators define correct technique as performing 10 out of 12 steps in the inhaler technique checklist. The following statistic for each arm is for the participants who reported being confident in their inhaler technique, the number of that sub-population that demonstrated satisfactory inhaler technique"|1 hour at Visits V0-V1 initial hospital study visit|For the TTG arm, 18 out of 24 individuals self-reported being confident in their inhaler technique. In the BI arm, 18 out of 26 reported being confident in their inhaler technique.|||Participants|||Count of Participants
2674347|NCT01456494|Secondary|Differences in the Prevalence of Reported Acute Health-related Events 90 Days Post Hospital Discharge Between TTG and BI||90 days (from Visits V0-V3, ie from initial hospital visit to 90 days day post discharge phone interview)|Due to lost to follow-up, the investigators did not collect and analyze acute health related events 90 days post discharge.||||||
2674354|NCT01456221|Other Pre-specified|Change in Insulin Resistance Through Fasting Insulin|Change from baseline in insulin resistance at three and six months. Changes in insulin resistance evaluated through fasting insulin (µU/mL)|At baseline (at diagnosis), three months, throughout six months.|Of the participants analyzed at baseline and at month 3 (119 in omega 3 and an hypocaloric diet group and 126 Placebo group) only 80 and 82 participants respectively finished the study at month 6. The participants who did not finish the study, were because they did not want to take another blood sample at month 6.|||µU/mL||Standard Deviation|Mean
2674355|NCT01456221|Secondary|Nutritional Status|Nutritional status was determined by registering body mass index (BMI) calculated by formula: kg/m^2.|At baseline (at diagnosis), three months, throughout six months.|Of the participants analyzed at baseline and at month 3 (119 in omega 3 and an hypocaloric diet group and 126 Placebo group) only 80 and 82 participants respectively finished the study at month 6. The participants who did not finish the study, were because they did not want to take another blood sample at month 6.|||kg/m^2||Standard Deviation|Mean
2674356|NCT01456221|Primary|Change in Insulin Resistance|Change from baseline in insulin resistance at three and six months. Changes in insulin resistance evaluated through Homeostasis Model Assessment Index (HOMA), calculated by formula: (glucose, mg * insulin,µU)/405. Where HOMA>3.16 indicated insulin resistance index.|At baseline (at diagnosis), three months, throughout six months.|Of the participants analyzed at baseline and at month 3 (119 in omega 3 and an hypocaloric diet group and 126 Placebo group) only 80 and 82 participants respectively finished the study at month 6. The participants who did not finish the study, were because they did not want to take another blood sample at month 6.|||HOMA-IR Index||Standard Deviation|Mean
2674357|NCT01456195|Secondary|Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Meal Tolerance Test (MTT)|The change between the value of glucose after a meal, measured by the meal tolerance test collected at Week 24 relative to Baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and 2 hours after the start of the meal measured in millimoles per liter (mmol/L). An Analysis of Covariance (ANCOVA) model with treatment and country as fixed factors and Baseline value as covariate was used for analysis.|Baseline and Week 24|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included. MTT were only done at sites that had MTT capabilities.|||mmol/L||Standard Error|Least Squares Mean
2674358|NCT01456195|Secondary|Change From Baseline in Fasting Plasma Glucose|The change between the fasting plasma glucose value collected at Week 24 relative to Baseline measured in milligrams per deciliter (mg/dL). A MMRM model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis.|Baseline and Week 24|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included.|||mg/dL||Standard Error|Least Squares Mean
2674359|NCT01456195|Secondary|Incidence of HbA1c <7%|The incidence (percentage of participants with) HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) of less than seven percent for target glycemic control at Week 24.|Week 24|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included. Last Observation Carried Forward.|||percentage of participants|||Number
2674360|NCT01456195|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 24 relative to Baseline. A mixed model repeated measures (MMRM) model with treatment, country, visit and visit by treatment interaction as fixed factors and with Baseline value and Baseline value by visit interaction as covariates with an unstructured covariance structure was used for analysis.|Baseline and Week 24|Participants from the Full Analysis Set, all randomized participants who received at least one dose of study drug, with data available for analysis. Only participants with Baseline and at least 1 post-Baseline value are included.|||percent||Standard Error|Least Squares Mean
2674361|NCT01456169|Secondary|Percentage of Participants Who Achieve Both Clinic Systolic and Diastolic Blood Pressure Targets at Week 8|Percentage of participants who achieve both clinic systolic and diastolic blood pressure targets at Week 8, defined as less than 140 mm Hg (or less than 130 mm Hg for participants with diabetes or chronic kidney disease) for systolic AND less than 90 mm Hg (or less than 80 mm Hg for participants with diabetes or chronic kidney disease) for diastolic blood pressure.|Week 8|Full analysis set|||percentage of participants|||Number
2674362|NCT01456169|Secondary|Percentage of Participants Who Achieve a Target Clinic Diastolic Blood Pressure at Week 8|Percentage of participants who achieve a target clinic diastolic blood pressure measured at final visit or week 8, defined as less than 90 mm Hg (or less than 80 mm Hg for participants with diabetes or chronic kidney disease). Diastolic blood pressure is based on the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Week 8|Full analysis set|||percentage of participants|||Number
2674363|NCT01456169|Secondary|Percentage of Participants Who Achieve a Target Clinic Systolic Blood Pressure at Week 8|Percentage of participants who achieve a target clinic systolic blood pressure measured at final visit or week 8, defined as less than 140 mm Hg (or less than 130 mm Hg for participants with diabetes or chronic kidney disease). Systolic blood pressure is the arithmetic mean of the 3 trough sitting Systolic blood pressure measurements.|Week 8|Full analysis set|||percentage of participants|||Number
2674364|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Diastolic Blood Pressure 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean diastolic blood pressure measured at final visit or Week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.|||mm Hg||Standard Error|Least Squares Mean
2674365|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Systolic Blood Pressure 0 to 12 Hours After Dosing, as Measured by Ambulatory Blood Pressure Monitoring|The change in the 12-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 12-hour mean is the average of all measurements recorded in the first 12 hours after dosing.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.|||mm Hg||Standard Error|Least Squares Mean
2674366|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Nighttime Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in nighttime (12 am to 6 am) mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8.|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.|||mm Hg||Standard Error|Least Squares Mean
2674367|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Nighttime Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in nighttime (12 am to 6 am) mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Nighttime mean is the average of all measurements recorded between the hours of 12 am and 6 am.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.|||mm Hg||Standard Error|Least Squares Mean
2674368|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Daytime Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in daytime (6 am to 10 pm) mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.|||mm Hg||Standard Error|Least Squares Mean
2674369|NCT01456169|Secondary|Change From Baseline to Week 8 in the Mean Daytime Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in daytime (6 am to 10 pm) mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. Daytime mean is the average of all measurements recorded between the hours of 6 am and 10 pm.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.|||mm Hg||Standard Error|Least Squares Mean
2674370|NCT01456169|Secondary|Change From Baseline to Week 8 in the 24-hour Mean Diastolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.|||mm Hg||Standard Error|Least Squares Mean
2674371|NCT01456169|Secondary|Change From Baseline to Week 8 in the 24-hour Mean Systolic Blood Pressure, as Measured by Ambulatory Blood Pressure Monitoring|The change in 24-hour mean systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The 24-hour mean is the average of all measurements recorded for 24 hours after dosing.|Baseline and Week 8|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included.|||mm Hg||Standard Error|Least Squares Mean
2674372|NCT01456169|Secondary|Change From Baseline to Week 8 in Trough Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring|The change in trough diastolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8, 22-24 hours after dosing|Full analysis set. Only participants with a Baseline and at least 1 post-baseline value of acceptable quality were included|||mm Hg||Standard Error|Least Squares Mean
2674373|NCT01456169|Secondary|Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring|The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.|Baseline and Week 8, 22-24 hours after dosing|Full analysis set. Only participants with a baseline and at least 1 post-baseline value of acceptable quality were included.|||mm Hg||Standard Error|Least Squares Mean
2674374|NCT01456169|Secondary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Diastolic Blood Pressure|The change between trough diastolic blood pressure measured at final visit or week 8 relative to baseline Diastolic blood pressure is the arithmetic mean of the 3 trough sitting diastolic blood pressure measurements.|Baseline and Week 8|Full analysis set; LOCF was used.|||mm Hg||Standard Error|Least Squares Mean
2674375|NCT01456169|Primary|Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure|The change between trough systolic blood pressure measured at final visit or Week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.|Baseline (of the double-blind treatment period) and Week 8|Full analysis set, consisting of all randomized participants who received at least 1 dose of double-blind study drug. A participant was included in the analyses only when there was both a baseline value and at least 1 value during the double-blind treatment period. Last observation carried forward (LOCF) was used.|||mm Hg||Standard Error|Least Squares Mean
2674415|NCT01455545|Secondary|Asthma Severity According to Level of Asthma Control.|"Analyze the relation Between the Level of Asthma Control According to the Asthma Control Test (ACT) Score and asthma severity according the Global Initiative for Asthma (GINA).~Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19."|4 months||||participants|||Number
2674376|NCT01456143|Primary|Interrater Reliability|Amount of agreement among the 11 blinded head and neck cancer specialists, determined by the Fleiss Kappa. 33 benign and 65 cancer images were evaluated by the reviewers who were blinded to the anatomical site, tumor subsite, and final histopathologic diagnosis. Each reviewer was asked to classify each image as benign or neoplastic. The reviewers evaluated the images based on nuclear size, nuclear to cytoplasmic ratio, and overall cell architecture. Images were randomized in their presentation to the reviewers as to not establish any pattern. Each reviewer provided their interpretation in isolated settings to avoid influence from other reviewers.|Immediately following image (day of enrollment or up to 2 weeks after enrollment)||||proportion of agreement among 11 experts||95% Confidence Interval|Number
2674377|NCT01456143|Primary|Negative Predictive Value|NPV = proportion of those with a negative test without neoplasia compared to pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)||||Percent of images with correct diagnosis||95% Confidence Interval|Mean
2674378|NCT01456143|Primary|Positive Predictive Value|PPV = proportion of those with a positive test who have neoplasia compared to pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)||||Percent of images with correct diagnosis||95% Confidence Interval|Mean
2674379|NCT01456143|Primary|Specificity|Specificity = Probability that the HRME correctly classifies as negative those without neoplasia compared to pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)||||Percent of images with correct diagnosis||95% Confidence Interval|Mean
2674380|NCT01456143|Primary|Sensitivity|Sensitivity = probability that the HRME correctly classifies as positive those with neoplasia compared to pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)||||Percent of images with correct diagnosis||95% Confidence Interval|Mean
2674381|NCT01456143|Primary|Accuracy|Accuracy of reviewers in differentiating neoplastic or benign mucosa in comparison to the pathology results|Immediately following image (day of enrollment or up to 2 weeks after enrollment)||||Percent of images with correct diagnosis||95% Confidence Interval|Mean
2674382|NCT01456130|Secondary|Change From Baseline in Fasting Glucose|The change in the value of fasting glucose collected at Week 52 or the final visit relative to Baseline.|Baseline and Week 52|Full analysis set.|||mg/dL||95% Confidence Interval|Mean
2674383|NCT01456130|Secondary|Percentage of Participants With a Clinical Response|Clinical response is defined as an HbA1c level less than 5.8% or less than 6.5% at Week 52 or at the final visit.|Week 52|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2674384|NCT01456130|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c)|The change in the value of glycosylated hemoglobin collected at Week 52 or at the final visit relative to Baseline.|Baseline and Week 52|Full analysis set: All randomized participants who received at least one dose of double-blind study medication.|||percentage of glycosylated hemoglobin||95% Confidence Interval|Mean
2674385|NCT01456130|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|An TEAE is any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have a causal relationship with this treatment. A serious TEAE is defined as any untoward medical occurrence that resulted in death, was life threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability or incapacity, led to a congenital anomaly/birth defect or was an important medical event that may have required intervention to prevent any of items above.|52 Weeks|Safety analysis set - All participants who received at least one dose of the investigational product (alogliptin) and a rapid-acting insulin secretagogue.|||participants|||Number
2674386|NCT01456052|Secondary|Change From Baseline in Total Modified Mayo Score|A modified Mayo score was used to evaluate disease activity using 4 components, including stool frequency, rectal bleeding, endoscopy, and physician assessment. Components = Stool frequency score 0-3 (normal- >4 stools/day more than normal), rectal bleeding score 0-3 (none-passing blood alone), mucosal appearance at endoscopy 0-3 (normal-severe disease), physician rating of disease activity 0-3 (normal-severe). The total Modified Mayo score ranges from 0 to 12, with higher scores indicating greater disease severity.|Baseline to 8 weeks|Participants from the ITT Population, all randomly assigned participants, with data available for analysis.|||units on a scale||Standard Deviation|Mean
2674387|NCT01456052|Secondary|Number of Participants Achieving Clinical Remission|"Clinical remission is defined as a total modified Mayo score ≤2 with no individual score >1 at Week 8.~A modified Mayo score was used to evaluate disease activity using 4 components, including stool frequency, rectal bleeding, endoscopy, and physician assessment. Components = Stool frequency score 0-3 (normal- >4 stools/day more than normal), rectal bleeding score 0-3 (none-passing blood alone), mucosal appearance at endoscopy 0-3 (normal-severe disease), physician rating of disease activity 0-3 (normal-severe). The total Modified Mayo score ranges from 0 to 12, with higher scores indicating greater disease severity."|Baseline to 8 weeks|ITT Population included all randomly assigned participants.|||participants|||Number
2674388|NCT01456052|Secondary|Number of Participants Achieving Clinical Response|"Clinical response is defined as a decrease in the total modified Mayo score from baseline of ≥3 or a ≥30% decrease in the total modified Mayo score from baseline, along with a decrease in the rectal bleeding score ≥1 or an absolute rectal bleeding score ≤1 at Week 8.~A modified Mayo score was used to evaluate disease activity using 4 components, including stool frequency, rectal bleeding, endoscopy, and physician assessment. Components = Stool frequency score 0-3 (normal- >4 stools/day more than normal), rectal bleeding score 0-3 (none-passing blood alone), mucosal appearance at endoscopy 0-3 (normal-severe disease), physician rating of disease activity 0-3 (normal-severe). The total Modified Mayo score ranges from 0 to 12, with higher scores indicating greater disease severity."|Baseline to 8 weeks|Intent-to-treat (ITT) Population included all randomly assigned participants.|||participants|||Number
2674389|NCT01456052|Primary|Number of Participants Experiencing a Treatment Emergent Adverse Event||8 weeks|Safety population included all treated participants who had taken any fraction of a study drug dose.|||participants|||Number
2674430|NCT01455519|Secondary|Change in NRS After Stair Climb|Numeric Rating Scale (NRS) pain score was given verbally after completing functional stair climb test on a scale 0-10 (0=none, and 10=the worst).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||NRS pain score||Standard Error|Mean
2674390|NCT01456039|Secondary|Kaplan Meier (K-M) Estimate of Time to Progression (TTP) in PTCL Participants Based on the Modified 2007 IWC as Assessed by IER|Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|ITT includes all participants who received at least one dose of romidepsin|||days||95% Confidence Interval|Median
2674391|NCT01456039|Secondary|Kaplan Meier Estimate of Time to Progression (TTP) in PTCL Participants Based on the 1999 IWC as Assessed by IER|Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|ITT includes all participants who received at least one dose of romidepsin|||days||95% Confidence Interval|Median
2674392|NCT01456039|Secondary|Kaplan Meier Estimate of Duration of Response (DOR) for PTCL Responders Based on the Modified 2007 IWC as Assessed by the IER.|DOR was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression, analyzed using Kaplan-Meier methods.|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)|||days||95% Confidence Interval|Median
2674393|NCT01456039|Secondary|Kaplan Meier Estimate of Duration of Response (DOR) for PTCL Responders Based on the Modified 1999 IWC as Assessed by the IER.|DOR was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression, analyzed using Kaplan-Meier methods.|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)|||days||95% Confidence Interval|Median
2674394|NCT01456039|Secondary|Time to Response (TTR) for PTCL Participants With at Least a PR Based on the Modified 2007 IWC as Assessed by IER|TTR for PTCL was defined as the time in days from first dose date to the first date of objective disease response.|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)|||days||Full Range|Median
2674395|NCT01456039|Secondary|Time to Response (TTR) for PTCL Participants With at Least a PR Based on the Modified 1999 IWC as Assessed by IER|TTR for PTCL was defined as the time in days from first dose date to the first date of objective disease response.|Median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)|||days||Full Range|Median
2674396|NCT01456039|Secondary|Percentage of PTCL Participants With the Best Response in Accordance With the Modified 2007 International Workshop Response Criteria as Assessed by IER|Objective disease response in PTCL was defined as achieving a CR or PR based on the Modified 2007 IWC. A CR = a complete disappearance of all disease; lymph node mass regression to normal size on computerized tomography (CT) scan or negative on positron emission tomography (PET); non-palpable splenic and disappearance of liver nodules; infiltrate cleared on repeat bone marrow (BM), immunohistochemistry negative. PR = a reduction of measurable lesions; ≥ 50% decrease in sum of the products of the greatest diameters (SPD) of up to 6 largest dominant masses, no enlargement in size of other nodes; ≥ 50% decrease in SPD and no increase in liver or spleen.|Tumor assessments performed every 2 months; median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of romidepsin|||percentage of participants||95% Confidence Interval|Number
2674397|NCT01456039|Secondary|The Percentage of Participants With Abnormal Q-wave and T Wave Intervals|The time from the start of the Q-wave to the end of the T-wave QTc intervals greater than 450 msec post-baseline performed by centralized reviewer. The Bazett's (QTcB) and Fridericia (QTcF) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval|Median follow-up: 100 days; up to data cut-off of 28 July 2015|The ECG population includes all participants who received romidepsin on Day 1 of Cycle 1 with at least one post-baseline QTc result|||percentage of participants|||Number
2674398|NCT01456039|Secondary|Cmax Accumulation Ratio of Romidepsin in Phase 1, Cycle 1|Cmax of Romidepsin: accumulation ratio based on Cmax calculated as Cmax,ss/Cmax|Day 1 and Day 15 in Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at end of administration) hours after the start of administration, 0.25, 0.5, 1, 2, 4, 6, 20, and 44 hours after the end of administration. Day 8, Cycle 1, samples collected at 0 hour|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2674399|NCT01456039|Secondary|AUC0-t, Accumulation Ratio of Romidepsin in Phase 1, Cycle 1|Area under the plasma concentration-time curve from time zero to the last quantifiable time point; accumulation ratio calculated as AUC (0-t),ss/AUC (0-t)|Day 1 and Day 15 in Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2674431|NCT01455519|Secondary|Change in Time to Lift Box|Time to lift 13 pound box to floor and back up to table.|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||seconds per lift||Standard Error|Mean
2674400|NCT01456039|Secondary|Terminal Phase Half-life of Romidepsin (t½) in Phase 1 at Cycle 1, Day 15|The terminal phase half-life of romidepsin after a single dose on Day 15, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.|Day 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration.|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||hours||Geometric Coefficient of Variation|Geometric Mean
2674401|NCT01456039|Secondary|Tmax,ss of Romidepsin in Phase 1 at Cycle 1, Day 15|Observed time to first maximum plasma concentration at steady state|Day 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||hours||Full Range|Median
2674402|NCT01456039|Secondary|Cmax, ss of Romidepsin in Phase 1 at Cycle 1, Day 15|Maximum observed concentration in plasma at steady state|Day 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2674403|NCT01456039|Secondary|AUC0-t, at Steady State (ss) of Romidepsin in Phase 1 at Cycle 1, Day 15|Area under the plasma concentration-time curve from time zero to the last quantifiable time point at steady state, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing|Day 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2674404|NCT01456039|Secondary|Apparent Volume of Distribution (Vz/F) of Romidepsin in Phase 1|Apparent volume of distribution, was calculated according to the equation: Vd/F = (CL/F)/λz|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2674405|NCT01456039|Secondary|Apparent Total Clearance of Romidepsin (CL/F) of Romidepsin in Phase 1|The apparent total clearance of romidepsin after a single dose on Day 1, calculated as dose/AUC0-infinity.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration.|PK population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2674406|NCT01456039|Secondary|Terminal Phase Half-life of Romidepsin (t½) in Phase 1|The terminal phase half-life of romidepsin after a single dose on Day 1, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration.|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||hours||Geometric Coefficient of Variation|Geometric Mean
2674407|NCT01456039|Secondary|Time to Maximum Plasma Concentration of Romidepsin (Tmax) in Phase 1|The time to first maximum observed plasma concentration of romidepsin after a single dose on Day 1.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||hours||Full Range|Median
2674408|NCT01456039|Secondary|Maximum Plasma Concentration (Cmax) of Romidepsin in Phase 1|The maximum observed plasma concentration of romidepsin (Cmax) obtained directly from the observed concentration versus time data|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|Pharmacokinetic (PK) Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2674409|NCT01456039|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Romidepsin in Phase 1|Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC∞) of romidepsin on Day 1; if possible the area under the concentration-time curve from time zero to infinity, calculated by the linear trapezoidal rule and extrapolated to infinity was calculated according to the following equation: AUC∞ = AUCt + (Ct/ λz ), where Ct is the last quantifiable concentration.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population consisted of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for romidepsin for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2674410|NCT01456039|Secondary|Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Romidepsin in Phase 1|Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing.|Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration|PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2674411|NCT01456039|Secondary|Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin|An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. An AE that resulted in any of the outcomes was defined as a serious (SAE): • Death • Life-threatening event • An inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity; • Congenital anomaly or birth defect • Other important medical event The investigator judged the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide an explanation for the event. The severity of an AE was evaluated by the investigator according to Common Terminology Criteria for Adverse Events (CTCAE Version 3.0), Japanese Clinical Oncology Group (JCOG) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.|Day 1 of study drug through 30 days after the last dose of study drug or discontinuation date; Up to data cut-off of 28 July 2015; maximum follow up time was 184.3 weeks|Safety population includes all participants who received at least one dose of romidepsin|||participants|||Number
2674412|NCT01456039|Primary|Percentage of PTCL Participants With an Overall Best Response in Accordance With a Modified International Workshop Response Criteria (IWC) 1999 in Phase 2|Objective disease response in PTCL was defined as patients with a complete response (CR), unconfirmed complete response (CRu) or a partial response (PR) according to modified IWC 1999 criteria and assessed by an independent efficacy reviewer. A CR is >75% decrease in size of maximum 6 largest target within nodal and extranodal lesions, complete disappearance of other nodal and extranodal; total disappearance of clinical disease; disease-related signs and symptoms, normalization of biochemical abnormalities, disappearance of spleen, liver, or kidney enlargement; no bone marrow (BM) involvement, no new sites of disease. CRu: all above criteria fulfilled except for BM involvement is indeterminate. PR: a ≥50% decrease in size of 6 largest target lesions and no increase other nodal and extranodal; no progression of clinical disease; disease-related signs and symptoms, normalization or biochemical abnormalities, no progression in size of liver, spleen, or kidney; and no new sites of disease|Tumor assessments performed every 2 months; median follow-up time was 100 days; up to the data cut-off of 28 July 2015|Intent to treat population for participants with PTCL who received at least one dose of Romidepsin|||percentage of participants||95% Confidence Interval|Number
2674413|NCT01456039|Primary|Number of Participants With Dose-limiting Toxicity (DLT) in Accordance With National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 as Determined by the Efficacy and Safety Evaluation Committee (ESEC)|DLT was defined as an adverse event (AE) occurring in Cycle 1 in Phase 1 and judged that the causal relationship to the investigational product could not be denied. The severity of all AEs was graded based upon the NCI CTCAE version 3.0. DLTs were defined as: • Grade 4 Hemoglobin <6.5 g/dL • Grade 4 Neutrophil <500/μL continuing for at least 5 days • Febrile neutropenia (Grade 4 neutropenia caused by fever and ≥ 38.5° C for more than 1 hour) • Grade 4 thrombocyte (< 25,000/μL), or thrombocytopenia with hemorrhage requiring platelet transfusion • Nausea, vomiting, or diarrhea at > grade 3 in spite of treatment • Grade 3 ALT (alanine aminotransferase) or AST (aspartate aminotransferase) values continued for 7 days. • Grade 4 ALT or AST • Grade 2 arrhythmia • Grade 4 non-hematological AEs • Other grade 3 non-hematological AEs except transient fatigue, anorexia, hyponatremia, and tumor lysis syndrome • Other AEs leading to discontinuation of administration|Up to Day 28; Cycle 1|DLT population included all participants in the Phase 1 portion who received at least one dose of romidepsin. Of 8 participants enrolled in the 14mg/m^2 cohort, 2 participants, one with a critical Good Clinical Practice (GCP)violation and the other who did not complete Cycle 1 due to consent withdrawal, were excluded from the DLT assessment.|||participants|||Number
2674414|NCT01456000|Primary|Number of Participants That Meeting the Efficacy Success Criteria as Described in the Outcome Measure Description|Episodes of AF were monitored during the follow-up period and the rate of participants with no documented, symptomatic episodes of AF in follow-up were be compared. Other efficacy success/failure criteria included acute isolation of all clinically relevant pulmonary veins, lack of ablation-induced left atrial flutter, use of AADs during a follow-up period and left heart ablation or implant for AF in follow-up. Randomized and treated participants that were evaluable for efficacy are reported on for the Outcome Measure.|1 year||||Successful Participants|||Number
2674432|NCT01455519|Secondary|Change in Distance to Floor|Distance from fingers to Floor when bending forward. A functional test of flexibility|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||centimeters||Standard Error|Mean
2674416|NCT01455545|Secondary|Pulmonary Function Test (Spirometry) According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the ACT scores and pulmonary function test (spirometry).~Functional study. The Master Lab system (Jaeger, Wurzburg, Germany) was used to obtain spirometry parameters Respiratory function tests were performed according to the recommendations of the European Respiratory Society. The predicted values used for pulmonary function variables were obtained from the European Community for Coal and Steel. This will be performed according to the recommendations of European Respiratory Society using the Jaeger Master Lab system.~Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19."|4 months||||percentage of the theoretical||Standard Deviation|Mean
2674417|NCT01455545|Primary|Analyze How Adherence to Treatment Using Prescription Account Influences Level of Asthma Control.|"Analyze how adherence to treatment using prescription count influences level of asthma control in a sample of patients with severe and moderate-mild asthma. The second primary endpoint analyzes how adherence, using prescription counts, influences the level of asthma control. Good adherence to treatment was defined as a count of prescriptions issued by their family physician greater than 80% of the required treatment during the last 6 months.~Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19 . Good control if ACT score > 19."|4 weeks||||participants|||Number
2674418|NCT01455545|Secondary|Concomitant Psychiatric Disorders According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and concomitant psychiatric disorders.~Depression and anxiety were the concomitant psychiatric disorders. Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19."|4 weeks||||participants|||Number
2674419|NCT01455545|Secondary|Gastroesophageal Reflux According to Level of Asthma Control.|"Analyze the relation Between the Level of Asthma Control According to the ACT Score and gastroesophageal reflux.~Gastroesophageal reflux was diagnosed by symptoms or previous diagnosis in their medical records with or without treatment for reflux.~Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19."|4 weeks||||participants|||Number
2674420|NCT01455545|Secondary|Sinusitis According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) Score and Sinusitis.~Asthma control was measured by Asthma Control Test (ACT). Bad control if ACT score < or = 19. Good control if ACT score > 19.~Diagnosis of sinusitis was established according to The European Position Paper on Rhinosinusitis and Nasal Polyps (EP3OS) group."|4 weeks||||participants|||Number
2674421|NCT01455545|Secondary|Rhinitis According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and rhinitis.~Asthma control was measured by Asthma Control Test (ACT). Good control if ACT score > 19. Bad control if ACT score < or = 19.~Rhinitis was diagnosed by symptoms, according to Allergic Rhinitis and its Impact on Asthma(ARIA)guideline."|4 weeks||||participants|||Number
2674422|NCT01455545|Secondary|Obesity According to Level of Asthma Control.|"Analyze the correlation between the level of asthma control according to the Asthma Control Test (ACT) score and obesity, measured by body mass index(BMI). If BMI (18-25) = normal. If BMI (25 - 29) = overweight. If BMI > 30 obesity.~Asthma control was measured by Asthma Control test (ACT). Good control if ACT score > 19. Bad control if ACT score < or = 19 ."|4 weeks||||participants|||Number
2674423|NCT01455545|Secondary|Smoking Habit According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) score and smoking habit.~Good control if ACT score > 19. Bad control if ACT score < or = 19. Patients were divided into three types: active smokers, former smokers and people who had never smoked."|4 weeks||||participants|||Number
2674424|NCT01455545|Secondary|Gender According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) scores and the gender.~Asthma control was measured by Asthma Control Test(ACT). Good control if ACT score > 19. Bad control if ACT score < or = 19."|4 weeks||||participants|||Number
2674425|NCT01455545|Secondary|Fraction Exhaled of Nitric Oxide (FeNO) According to Level of Asthma Control.|"Analyze the relation between the level of asthma control according to the Asthma Control Test (ACT) scores and the fraction exhaled of nitric oxide (FeNO). Units FENO: ppb (parts per billion).~Asthma control was measured by Asthma Control Test(ACT). Bad control if ACT score < or = 19 . Good control if ACT score > 19."|4 weeks|The same as primary outcome.|||units on a scale (parts per billion)||Inter-Quartile Range|Median
2674426|NCT01455545|Primary|Analyze How Adherence to Treatment Using ASK-20 Questionnaire Influences Level of Asthma Control.|"The ASK-20 (Adherence Starts with Knowledge)is a brief, self-reported instrument developed to identify patient-specific barriers to medication adherence and to improve provider/patient communication about adherence.~Programs incorporating a clinical assessment tool such as the ASK-20 for identifying a broad range of risk factors for nonadherence and for developing patient-specific intervention may reduce adherence barriers and improve disease control and ability to perform daily activities in patients with asthma.~To gauge the overall risk of nonadherence, the total ASK-20 score was calculated,as the sum of the individual item score, ranging from 1 to 5 and therefore total ranges score from 20 (less barriers to adherence) to 100 (more barriers)."|4 weeks||||units on a scale||Inter-Quartile Range|Median
2674427|NCT01455519|Secondary|Change in NRS After Box Lift|Numeric Rating Scale (NRS) pain score was given verbally after completing functional box lift test on a scale 0-10 (0=none, and 10=the worst).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||NRS pain score||Standard Error|Mean
2674428|NCT01455519|Secondary|Change in NRS After Sit to Stand Repetitions|Numeric Rating Scale (NRS) pain score was given verbally after completing functional sit to stand test on a scale 0-10 (0=none, and 10=the worst).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||NRS pain score||Standard Error|Mean
2674429|NCT01455519|Secondary|Change in NRS After Treadmill Walk|Numeric Rating Scale (NRS) pain score was given verbally after completing functional treadmill walk test on a scale 0-10 (0=none, and 10=the worst).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||NRS pain score||Standard Error|Mean
2674436|NCT01455519|Secondary|Change in Pain Disability|The Pain Disability Index (PDI) is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||units on a scale||Standard Error|Mean
2674437|NCT01455519|Secondary|Change in PASS|Anxiety scores were collected at least two data points. The Pain Anxiety Symptoms Scale (PASS) is a scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||units on a scale||Standard Error|Mean
2674438|NCT01455519|Primary|Change in VAS|Visual Analogue Scale is a self report pain scale on a scale 0(no pain) to 100 (the worst pain imaginable).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||units on a scale||Standard Error|Mean
2674439|NCT01455519|Primary|Change in McGill Pain Questionnaire - Short Form|The McGill Pain Questionnaire - Short Form (MPQ-SF) is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are added together to compute a total score. The scale ranges from 0-45 (0=no pain, 45=the most pain).|Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention||||units on a scale||Standard Error|Mean
2674440|NCT01455428|Secondary|Change From Baseline in HADS Depression Total Score at Endpoint|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2674441|NCT01455428|Secondary|Change From Baseline in HADS Anxiety Total Score at Endpoint|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2674442|NCT01455428|Secondary|Baseline Hospital Anxiety and Depression Scale (HADS) Scores|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Deviation|Mean
2674443|NCT01455428|Secondary|Patient Global Impression of Change (PGIC) Score at Endpoint|The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant's perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).|Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2674444|NCT01455428|Secondary|Clinical Global Impression of Change (CGIC) Score at Endpoint|The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician's perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).|Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2674445|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2674454|NCT01455428|Secondary|Change From Baseline in PPI Scale From the SF-MPQ at Endpoint|The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).|Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2674446|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2674447|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2674448|NCT01455428|Secondary|Percentage of Participants Who Had Optimal Sleep at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night.|Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (consisted of all participants randomized to treatment that received at least 1 dose of study medication) with available data to contribute to the analysis.|||percentage of participants|||Number
2674449|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept).|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2674450|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2674451|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2674452|NCT01455428|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance.|Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure.|||units on a scale||Standard Error|Least Squares Mean
2674453|NCT01455428|Secondary|Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflected greater impairment in the MOS-Sleep subscales. The MOS-Sleep Scale was used to evaluate sleep during the previous week.|Baseline|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. The LOCF method was used in the analysis of this outcome measure.|||units on a scale||Standard Deviation|Mean
2674508|NCT01455181|Secondary|Mean Percentage Changes From Baseline in Oral Calcium at Each Visit||24 Weeks|The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement.|||percentage of change||Standard Deviation|Mean
2674509|NCT01455181|Secondary|Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit||24 Weeks||||percentage of change||Standard Deviation|Mean
2674455|NCT01455428|Secondary|Change From Baseline in Pain VAS From the SF-MPQ at Endpoint|The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain).|Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2674456|NCT01455428|Secondary|Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale|The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).|Baseline|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. The LOCF method was used in the analysis of this outcome measure. Number of participants evaluable for PPI=110, 108|||units on a scale||Standard Deviation|Mean
2674457|NCT01455428|Secondary|Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8|SF-MPQ was assessed according to the participant's answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain.|Baseline; Weeks 1, 3, 5, and 8|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=the number of participants who were evaluable for this measure at the given time point.|||units on a scale||Standard Deviation|Mean
2674458|NCT01455428|Secondary|Percentage of 30 Percent (%) Responders at Endpoint|"The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) compared to baseline."|End of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||percentage of participants|||Number
2674459|NCT01455428|Secondary|Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week.|Baseline and weekly from Weeks 1 to 8|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
2674460|NCT01455428|Secondary|Change From Baseline in Mean Sleep Interference Score at Endpoint|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.|Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2674461|NCT01455428|Secondary|Baseline Mean Sleep Interference Score|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10.|Baseline|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Deviation|Mean
2674462|NCT01455428|Secondary|Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8|"The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week."|Baseline and weekly from Weeks 1 to 8|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication.|||units on a scale||Standard Error|Least Squares Mean
2674463|NCT01455428|Primary|Change From Baseline in Mean Pain Score at Endpoint|"The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose."|Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)|All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used.|||units on a scale||Standard Error|Least Squares Mean
2674464|NCT01455428|Primary|Baseline Mean Pain Score|The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.|Baseline|All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used.|||units on a scale||Standard Deviation|Mean
2674465|NCT01455415|Secondary|PGIC Score at the End of Period 1 (Week 6) - Categorized Scores|The PGIC is a participant-rated instrument that measures the participant`s assessment of change in his/her overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). Original scores (7 different scores) and categorized scores (4 different scores) were provided. Categorized scores were very much improved (consisting of very much improved and much improved); any improvement (consisting of very much improved, much improved, and minimally improved); no change (consisting of no change); and any worsening (consisting of minimally worse, much worse, and very much worse). Due to the crossover design, PGIC was analyzed at the end of period 1 (V5).|End of Period 1 (V5)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period. All participants who were randomized and had a period 1 PGIC value were used for this analysis.|||percentage of participants|||Number
2674466|NCT01455415|Primary|Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)|"The daily pain diary consisted of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via interactive voice recognition system (IVRS) (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
2674467|NCT01455415|Secondary|Patient Global Impression of Change (PGIC) Score at the End of Period 1 (Week 6) - Original Scores|The PGIC is a participant-rated instrument that measures the participant`s assessment of change in his/her overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). Due to the crossover design, PGIC was analyzed at the end of period 1 (V5).|End of Period 1 (V5)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period. All participants who were randomized and had a period 1 PGIC value were used for this analysis.|||percentage of participants|||Number
2674468|NCT01455415|Secondary|EQ-5D Dolan 2002 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. The utility score is calculated using the Dolan 1997 algorithm and the revised version which was provided to the EuroQol Group by Dolan in 2001 - but later published in medical care in 2002.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
2674469|NCT01455415|Secondary|EQ-5D Dolan 1997 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. The utility score is calculated using the Dolan 1997 algorithm and the revised version which was provided to the EuroQol Group by Dolan in 2001 - but later published in medical care in 2002.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
2674470|NCT01455415|Secondary|EQ-5D Anxiety / Depression Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
2674510|NCT01455181|Primary|Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data.|A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.|24 Weeks||||percentage of participants||95% Confidence Interval|Number
2674471|NCT01455415|Secondary|EQ-5D Pain / Discomfort Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
2674472|NCT01455415|Secondary|EQ-5D Usual Activities Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
2674473|NCT01455415|Secondary|EQ-5D Self-Care Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
2674474|NCT01455415|Secondary|Euro QoL-5 Dimensions (EQ-5D) Mobility Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale (no problems, some/moderate problems, extreme problems) and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
2674475|NCT01455415|Secondary|Norfolk QOL-DN Autonomic Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). The autonomic domain score should be summed as follow: Σ (19, 20, 21). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items (range: 0 - 12). The QOL-DN version that was administered in this study was modified with a 2-week recall period."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
2674476|NCT01455415|Secondary|Norfolk QOL-DN Small Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). The small fiber domain score should be summed as follow: Σ (10, 16, 17, 18). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of the listed questionnaire items (range: 0 - 16). The QOL-DN version that was administered in this study was modified with a 2-week recall period."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
2674477|NCT01455415|Secondary|Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. With exception of questions 31 and 32, items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). In question 31, good, middle item, is scored as 0, very good as -1 , excellent as -2, fair as 1, and poor as 2. In question 32, about the same, middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. Physical functioning / large fiber domain score should be summed as follow: Σ (8, 11, 13 - 15, 24, 27 - 35). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of listed questionnaire items (range: -4 - 56). QOL-DN version that was administered in the study was modified with a 2-week recall period."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
2674569|NCT01454583|Primary|Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP)|Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 1 year, the difference divided by the baseline value, multiplied by 100|Baseline and 1 year||||percent change||Standard Deviation|Mean
2674478|NCT01455415|Secondary|Norfolk QOL-DN Activities of Daily Living Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). Activities of the daily living domain score should be summed as follow: Σ (12, 22, 23, 25, 26). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of listed questionnaire items (range: 0 - 20). The QOL-DN version that was administered in the study was modified with a 2-week recall period."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
2674479|NCT01455415|Secondary|Norfolk QOL-DN Symptoms Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. Item 9 is scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). The symptoms domain score should be summed as follow: Σ (1 - 7, 9). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items (range: 0 - 32). The QOL-DN version that was administered in this study was modified with a 2-week recall period."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
2674480|NCT01455415|Secondary|Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). In question 31, good, the middle item, is scored as 0, very good as -1, excellent as -2, fair as 1, and poor as 2. In question 32, about the same, the middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. TQOL score should be summed as follow: sum (Σ) (1 - 7, 8 - 35). The (sub)scales are calculated without weighting of any kind, and reported as the integer sum of listed questionnaire items (range: -4 - 136). The QOL-DN version that was administered in this study was modified with a 2-week recall period."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
2674481|NCT01455415|Secondary|HADS-D Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|HADS is a 14- item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4- point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
2674482|NCT01455415|Secondary|Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The Hospital Anxiety and Depression Scale (HADS) is a 14- item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4- point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
2674483|NCT01455415|Secondary|Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"The daily sleep diary consists of an 11-point numeric rating scale with which the participant rates how painful DPN pain has interfered with their sleep during the past 24 hours. Zero indicates does not interfere with sleep and 10 indicates completely interferes (unable to sleep due to pain). Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight) after completion of the daily pain diary."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
2674484|NCT01455415|Secondary|BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)|The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. Seven sub-questions evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on an 11-point scale (0: does not interfere; 10: completely interferes). Scores range from 0 - 10 with higher scores indicating greater interference.|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
2674485|NCT01455415|Secondary|Brief Pain Inventory-Short Form (BPI-sf) Score for Pain-Severity Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. Four items measure pain (0: no pain; 10: worst pain possible) at its worst, least, average, and now (current pain) on an 11-point scale. Scores range from 0 - 10 with higher scores indicating greater pain severity."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||units on a scale||Standard Error|Least Squares Mean
2674486|NCT01455415|Secondary|Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Daily pain diary consisted of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||percentage of participants|||Number
2674487|NCT01455415|Secondary|Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)|"Daily pain diary consisted of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain."|End of Period (includes both Visits 5 and 9)|The ITT population included all randomized participants with at least one dose of study drug. The ITT population was analyzed according to what the randomization schedule intended for the participants to take in each period.|||percentage of participants|||Number
2674488|NCT01455220|Secondary|Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))|Change in score on the Multiple Sclerosis Quality of Life (MSQOL-54) from end of study compared to baseline. The MSQOL-54 is a 54-item quality of life questionnaire that has general, as well as, MS specific questions covered in 6 sub-categories (mobility, symptoms, emotional well-being, general contentment, thinking and fatigue, family/social well-being). Minimum score of 0 to maximum score of 100. Overall quality of life is calculated by averaging question 53 and 54. The sub-scales( mental and physical health) are on a weighted scale. Sets of questions are totaled and divided by the number of questions in each section then that section total is multiplied by a weighted value. Then all weighted values are summed for all relevant question sections for that subscale to compute a composite score for both mental health and physical health. A higher score, indicates a higher perceived quality of life for the patient. A lower scorer indicates poorer quality of life impacted by MS.|Baseline, 6 months||||units on a scale||Standard Deviation|Mean
2674489|NCT01455220|Secondary|Health Related Quality of Life (as Measured by the Functional Assessment of MS (FAMS))|Change in score on the Functional Assessment of MS (FAMS) questionnaire.The FAMS consists of 44 scored items in six quality-of-life domains: Mobility (seven items), Symptoms (seven items), Emotional well being (seven items), General contentment (seven items), Thinking/fatigue (nine items), and Family/social well being (seven items). Minimum score of 0 to max score of 176. A higher scores indicates positive (better) functional health related quality.|Baseline, 6 months||||units on a scale||Standard Deviation|Mean
2674490|NCT01455220|Secondary|Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))|Change in composite score in the sexual function subscale of the Multiple Sclerosis Quality of Life (MSQOL-54) over 6 months of Natalizumab treatment. Minimum score of 0 and max score of 100. A higher score indicates a more positive outcome (less sexual dysfunction).|Baseline, 6 months||||units on a scale||Standard Deviation|Mean
2674491|NCT01455220|Primary|Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) )|Change in level of dysfunction demonstrated by the comparison and analysis of Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) responses at end of study to baseline. Minimum score of 19 to maximum score of 95, the higher score indicates a greater level of sexual dysfunction. Primary subscale (min 5 to max 25), Secondary subscale (min 9 to max 45), tertiary subscale (min 5 to max 25), subscale scores are summed for overall total score.|Baseline, 6 months||||units on a scale||Standard Deviation|Mean
2674492|NCT01455194|Secondary|Number of Participants With Markedly Abnormal Laboratory Values|The number of participants with any markedly abnormal standard safety laboratory values collected throughout study. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.|Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.|||participants|||Number
2674511|NCT01455064|Primary|Clarke Error Grid Analysis|Percentage of CGM results in the clinically accurate Zone A and percentage of CGM results in the clinically acceptable Zones A and B of the Clarke Error Grid versus blood glucose reference.|15 days sensor wear|One subject was withdrawn due to a mild reaction to the sensor adhesive. This subject's data was included in the study up to the point of withdrawal.|||Percentage of Results|Participants||Number
2674977|NCT01451411|Secondary|Change From Baseline in Free Water Clearance (FWC)||Baseline and 48 hours|The protocol specifies that calculations for this endpoint were to be derived by the statistical team. Due to the terminated status of the study, a statistical team was not employed and calculations to determine this variable were not performed.||||||
2674493|NCT01455194|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Physical Examination Findings|Physical examination consists of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) cardiovascular system; (4) respiratory system; (5) gastrointestinal system; (6) dermatologic system; (7) extremities; (8) musculoskeletal system; (9) nervous system; (10) lymph nodes; and (11) physical examinations other than body systems described in (1) to (10). Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.|Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.|||participants|||Number
2674494|NCT01455194|Secondary|Number of Participants Reporting Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, blood pressure (BP) and pulse rate. Normal range for vital signs included: Systolic BP >170 millimeters of mercury (mm Hg) or <85 mm Hg, Diastolic BP >105 mm Hg, resting pulse rate: >120 bpm or <50 bpm, difference in systolic BP at Visit x (increase or decrease) compared with pretreatment >40 mm Hg and difference in pulse rate at Visit x (increase or decrease) compared with pretreatment >30 bpm. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.|Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.|||participants|||Number
2674495|NCT01455194|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. AEs included both serious AEs and non-serious AEs. Baseline of double-blind treatment period was defined as the average of the measurements of the last 2 weeks at site prior to first intake of double-blind study medication.|Baseline period (Week -3 up to -1), treatment period (Baseline up to Week 56)|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.|||participants|||Number
2674496|NCT01455194|Secondary|Number of Participants With Markedly High Benefits|The analyses was intended to identify participant's subsets that would benefit from dose escalation. This analysis tested the potential factors, including age, sex, pretrial inhaled corticosteroid (ICS) dose category, history of exacerbations, baseline ACQ score, baseline BMI category and smoking status. ACQ includes 5 questions about symptoms, 1 about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled).Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >=1.5 indicates uncontrolled asthma. As predefined in the protocol, participants with missing data for any category were not included.|Week 1 up to Week 52|Safety analysis set included all participants who took at least 1 dose of study medication.One participant erroneously randomized into 160 mcg arm, actually received 640 mcg dose.For safety analysis, participants were analyzed based on the treatment they actually received.|||participants|||Number
2674497|NCT01455194|Secondary|Number of Participants Reporting Asthma Exacerbations Rates|Participants with at least 1 asthma exacerbation in the double-blind treatment period have been reported. As predefined in the protocol, the results for participants with missing data for any category were not included.|Baseline up to Week 52 (treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.|||participants|||Number
2674498|NCT01455194|Secondary|Number of Participants Reporting Time to First Asthma Exacerbation|Asthma exacerbations were defined as a worsening of asthma requiring either treatment with oral (or other systemic) glucocorticosteroids for at least 3 days or hospitalisation or a visit to the emergency room because of asthma. Baseline was defined as the average of the ACQ measurements of the last 2 weeks at site prior to first intake of double-blind study medication|Baseline up to Week 52 (treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.|||participants|||Number
2674499|NCT01455194|Secondary|Number of Participants Reporting Time to First Well-Controlled Asthma Measurement by ACQ Cut-Off Point|Well-controlled asthma was defined as an ACQ score of equal to or lower than the ACQ cut-off point.The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline up to Week 52 (treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.|||participants|||Number
2674566|NCT01454583|Primary|Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)|Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 3 years, the difference divided by the baseline value, multiplied by 100|Baseline and 3 years|Patients with DM or HF and RR measurement at baseline and 3 years follow-up|||percent change||Standard Deviation|Mean
2674500|NCT01455194|Secondary|Number of Participants Reporting Time to First Well-Controlled Asthma and ACQ Improvement|Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline up to Week 52 (treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.|||participants|||Number
2674501|NCT01455194|Secondary|Number of Participants With Well-controlled Asthma and ACQ Improvement at the End of the Study|Well-controlled asthma at the end of the study was defined as a participant with an ACQ score of 0.75 or lower. ACQ improvement was defined as a decrease in ACQ score of at least 0.5. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Week 52|The intent-to-treat ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.|||participants|||Number
2674502|NCT01455194|Secondary|Number of Weeks With Well-controlled Asthma Over the Course of the Study|The number of weeks with well-controlled asthma is defined as the number of weeks that the participant had an ACQ score of 0.75 or lower over the course of the study. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline up to Week 52 (treatment period)|The intent-to-treat ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.|||weeks|weeks||Number
2674503|NCT01455194|Secondary|Time Course of ACQ|The time course of the incidence of a 0.5 points improvement of ACQ score was evaluated. Mean ACQ values over time by treatment group for on-treatment site measurements was assessed. The time course of asthma control (ACQ) was done on a weekly base using home-based and site-based ACQ measurements. The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline, Week 52 (Treatment period)|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.|||Weeks||Full Range|Median
2674504|NCT01455194|Primary|Change From Baseline in ACQ Score to Tlast|The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Week 52|The ITT analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.|||units on a scale||Standard Error|Mean
2674505|NCT01455194|Primary|Asthma Control Questionnaire (ACQ) Score at Baseline|The ACQ was developed to measure the adequacy of asthma control in clinical research and in clinical practice. It includes 5 questions about symptoms, 1 question about beta 2 -agonist use and 1 about lung function (FEV1% predicted). Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma.|Baseline|The intent-to-treat (ITT) analysis set included participants having at least 1 postrandomization efficacy assessment.This outcome measure was planned to be analyzed on for the treatment period.|||units on a scale||Standard Error|Mean
2674506|NCT01455181|Secondary|Mean Change From Baseline in 24-hour Urine Calcium Excretion||24 Weeks|The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement.|||mg/24 hour||Standard Deviation|Mean
2674507|NCT01455181|Secondary|Proportion of Patients Achieving the Primary Endpoint at Each Visit|A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.|24 Weeks|The Intent-to-treat population, which includes all subjects who received at least one dose of study drug and had at least one efficacy measurement .|||percentage of participants|||Number
2674512|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 6 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 6 measures subject's tiredness or sleepiness during the day on a 11-point scale that ranges between 0 (not at all) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 6 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||units on a scale||Standard Deviation|Mean
2674513|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 5 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 5 measures the severity of RLS during day not rest on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 5 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||units on a scale||Standard Deviation|Mean
2674514|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 4 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 4 measures the severity of RLS during day rest on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 4 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||units on a scale||Standard Deviation|Mean
2674515|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 3 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 3 measures the severity of RLS during the night on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 3 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||units on a scale||Standard Deviation|Mean
2674516|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 2 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 2 measures the severity of RLS at time falling asleep on a 11-point scale that ranges between 0 (none) to 10 (very severe). The ratings are given by the subjects. A negative value in RLS-6 Item 2 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||units on a scale||Standard Deviation|Mean
2674517|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-6 Rating Scales (RLS-6) Item 1 at the End of the 4-week Maintenance Period|The RLS-6 consists of 6 items of which four items are designed to assess severity of RLS and two items cover sleep and daytime tiredness. Item 1 measures subject's satisfaction with sleep on a 11-point scale that ranges between 0 (completely satisfied) to 10 (completely dissatisfied). The ratings are given by the subjects. A negative value in RLS-6 Item 6 Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||units on a scale||Standard Deviation|Mean
2674518|NCT01455012|Secondary|Clinical Global Impressions (CGI) Item 3 (Therapeutic Efficacy) at the End of the 4-week Maintenance Period|"The CGI Item 3 score measures the therapeutic efficacy on a 4-point scale consisting of the following categories:~1- Very good~2- Moderate~3- Slight~4- Unchanged or worse"|At the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||participants|||Number
2674519|NCT01455012|Secondary|Clinical Global Impressions (CGI) Item 1 (Severity of Illness) at the End of the 4-week Maintenance Period|"The CGI Item 1 score measures the severity of illness on a 7-point scale consisting of the following categories:~1- Normal, not ill at all~2- Borderline ill~3- Mildly ill~4- Moderately ill~5- Markedly ill~6- Severely ill~7- Among the most extremely ill subjects"|At the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||participants|||Number
2674520|NCT01455012|Secondary|Clinical Global Impressions (CGI) Item 2 (Change of Condition) at the End of the 4-week Maintenance Period|"The CGI Item 2 score measures any change in severity of RLS from Baseline on a 7-point scale consisting of the following categories:~1- Very much improved~2- Much improved~3- Minimally improved~4- No change~5- Minimally worse~6- Much worse~7- Very much worse"|At the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||participants|||Number
2674521|NCT01455012|Secondary|Change From Baseline in Restless Legs Syndrome-Quality of Life (RLS-QoL) at the End of the 4-week Maintenance Period|The RLS-QoL is a disease-specific instrument for the evaluation of Quality of life. It consists of 12 items and the overall sum score is calculated from all 12 items and measured on a scale that ranges from 0 (lowest Quality of life) to 60 (highest level of Quality of life). A negative value in RLS-QoL Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||units on a scale||Standard Deviation|Mean
2674522|NCT01455012|Secondary|Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at the End of the 4-week Maintenance Period|The IRLS is a subject-based scale that consists of 10 items to evaluate the severity of major RLS symptoms and the impact of the disease on subjects' daytime functioning. Each of the 10 items is measured on a scale that ranges from 0 (not present) to 4 (severe). A sum score between 0 (no RLS symptoms present at all) and 40 (maximum severity in all symptoms) across all 10 items was calculated. A negative value in IRLS Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||units on a scale||Standard Deviation|Mean
2674523|NCT01455012|Secondary|Change From Baseline in the Periodic Limb Movements Index (PLMI) at the End of the 4-week Maintenance Period|The PLMI is defined as Periodic Limb Movements (PLMs)/ total time in bed in hours. PLMs are measured by Polysomnography (PSG). A negative value in PLMI Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||Periodic Limb Movements/hour||Standard Deviation|Mean
2674524|NCT01455012|Secondary|Change From Baseline in the Total Number of Elevations of Systolic Blood Pressure (BP) During the Night at the End of the 4-week Maintenance Period|"Polysomnography (PSG) recordings, including the assessment of continuous Blood Pressure and 12-lead Electrocardiogram (ECG), were obtained on 2 consecutive nights prior to Baseline Visit and prior to End of Maintenance Period (Visit 7) for up to 8 hours per night. Readings from the first night of the PSG were only used for analysis if the PSG from the second night was determined to be not valid for evaluation. Influence of Periodic Limb Movements (PLMs) on sleep is reflected in the Periodic Limb Movement-Related Arousal Index (PLMAI). Arousal is defined as sudden change in the EEG activity and the index illustrates to what degree the PLMs contribute to arousal from sleep. Sleep stages and time spent in each sleep stage were determined from Electroencephalogram (EEG) readings.~A negative value in Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement."|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||Nocturnal Elevations of Systolic BP||Standard Deviation|Mean
2674525|NCT01455012|Primary|Change From Baseline in the Number of Elevations of Systolic Blood Pressure (BP) During the Night That Are Associated With Periodic Limb Movements (PLMs) at the End of the 4-week Maintenance Period|"Polysomnography (PSG) recordings, including the assessment of continuous Blood Pressure and 12-lead Electrocardiogram (ECG), were obtained on 2 consecutive nights prior to Baseline Visit and prior to End of Maintenance Period (Visit 7) for up to 8 hours per night. Readings from the first night of the PSG were only used for analysis if the PSG from the second night was determined to be not valid for evaluation. Influence of Periodic Limb Movements (PLMs) on sleep is reflected in the Periodic Limb Movement-Related Arousal Index (PLMAI). Arousal is defined as sudden change in the EEG activity and the index illustrates to what degree the PLMs contribute to arousal from sleep. Sleep stages and time spent in each sleep stage were determined from Electroencephalogram (EEG) readings.~A negative value in Change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement."|Baseline to the end of the 4-week Maintenance Period|Full Analysis Set (FAS) includes all randomized subjects having both a Baseline and a post-Baseline measurement for the primary efficacy variable. All 66 subjects in the FAS are included in the analysis of this Outcome Measure.|||Nocturnal Elevations of Systolic BP||95% Confidence Interval|Least Squares Mean
2674526|NCT01454947|Secondary|Antibiotic Prescribing Rates for Expanded List of Acute Respiratory Infection Diagnoses|We will monitor overall prescribing for the specified diagnoses and other acute respiratory infection diagnoses, including cough/fever and pneumonia.|18 months|||||||
2674527|NCT01454947|Primary|Inappropriate Antibiotic Prescribing Rate for Qualifying Acute Respiratory Infection Diagnoses|"Assess inappropriate antibiotic prescribing rates (relative to all practices that did not receive the intervention) for antibiotic-inappropriate acute respiratory tract infection visits and no concomitant reason for antibiotic prescribing. based on the following non-antibiotic-appropriate International Statistical Classification of Diseases, version 9 (ICD-9) diagnoses:~460 Acute nasopharyngitis (common cold)~465 Acute laryngeopharyngitis/acute upper respiratory infection~466 Acute bronchitis~490 Bronchitis not specified as acute or chronic~487 Flu"|18 months|We identified a total of 16,959 non-antibiotic-appropriate acute respiratory infection (ARI) visits. Visits were categorized as inappropriate if there were diagnosis codes for non-specific upper respiratory infections, acute bronchitis, and/or influenza.|||inappropriate prescribing rate|Qualifying ARI visits|95% Confidence Interval|Number
2674528|NCT01454934|Secondary|Objective Response Rate (ORR)|The ORR was defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST criteria. The ORR was estimated by study arm based on the tumor response evaluation as determined by the investigator, according to RECIST 1.1. Participants with unknown response were treated as non-responders. The statistical difference in ORR between treatment arms was evaluated using the Cochran-Mantel-Haenszel (CMH) chi-square test with histology, TPC option, and geographic region as strata, tested at an alpha level of 0.05 (2-sided). The 95 percent confidence interval (CI) was calculated using Clopper Pearson method.|Randomization (Day 1) to CR or PR|Full analysis set included all randomized participants.|||percentage of participants||95% Confidence Interval|Number
2674529|NCT01454934|Secondary|Progression Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST)|PFS was defined as the time from the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first. The difference in PFS (based on the tumor response evaluation as determined by the investigator) between eribulin mesylate and TPC was evaluated using the log rank test, stratified by histology, TPC option, and geographic region, tested at an alpha level of 0.05 (2-sided). PFS censoring rules will be defined in the SAP and follow Federal Department of Agriculture (FDA) guidance.|Randomization (Day 1) until date of disease progression or death (whichever occurred first), or 37 months|Full analysis set included all randomized participants.|||months||95% Confidence Interval|Median
2674530|NCT01454934|Primary|Overall Survival (OS)|The OS was defined as the time in months from the date of randomization to the date of death, regardless of cause. In the absence of confirmation of death, the participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. The two treatment arms were compared using the log-rank test, stratified by histology, TPC option, and geographic region; and the treatment difference between eribulin mesylate and TPC was tested at a significance level of 0.05 (2-sided). Kaplan-Meier (K-M) survival probabilities for each arm were plotted over time. The treatment effect was estimated by fitting a Cox Proportional Hazards model to the OS times including treatment arm as a factor and histology, TPC option and geographic region as strata.|Randomization (Day 1) until date of death from any cause, or 37 months|Full analysis set included all randomized participants.|||months||95% Confidence Interval|Median
2674531|NCT01454830|Secondary|Acceptability of Study Intervention and Comparative Group|"Feasibility assessment to determine participant acceptance of the study intervention and comparative condition (i.e., usual care); semi-structured interviews conducted with 50% of participants randomly assigned to interview at study termination and debriefing (3 months)"|3 months|"Acceptability rating by participants allocated to interview at study termination and debriefing; self-reported rating for binary response to satisfaction with study experience (yes/no); reported as percentage responding yes; no data available for participants who withdrew or were excluded prior to 3-month visit."|||"percentage of allocated responding yes"|||Number
2674532|NCT01454830|Secondary|Proportion of Participants Who Withdrawal|Feasibility assessment - withdrawal by participants for feasibility outcome of pilot RCT|Duration of protocol period|Considers only participant withdrawals requested from study|||percentage of participants|||Number
2674533|NCT01454830|Secondary|Proportion of Participants Who Complete Protocol After Allocation|Feasibility assessment - retention after enrollment and allocation employed as a feasibility outcome of pilot RCT|Duration of protocol period|Considers only participant withdrawals, administrative withdrawals for incomplete protocol procedures due to attrition; does NOT include excluded by a priori determined exclusion criteria for protocol|||percentage of participants|||Number
2674534|NCT01454830|Secondary|Proportion of Sleep Time on CPAP|% of Total Sleep Time (TST) using CPAP|1 week|Randomized participants with complete primary outcome data and secondary outcome data (total sleep time) measured by concurrent wrist actigraphy during first week of PAP treatment|||percentage of TST on PAP||Standard Deviation|Mean
2674535|NCT01454830|Primary|Nightly CPAP Use|Mean CPAP use, hrs/night|3 months||||hours/night||Standard Deviation|Mean
2674536|NCT01454830|Primary|Nightly CPAP Use|Mean CPAP use, hrs/night|1 month||||hours/night||Standard Deviation|Mean
2674537|NCT01454830|Primary|Nightly CPAP Use|Mean CPAP use, hrs/night|1 week||||hours/night||Standard Deviation|Mean
2674538|NCT01454791|Secondary|Subject Global Impression at 2 Weeks|"This is a single question: How would you rate your level of comfort with Copaxone injection during the past two weeks? Responses include Extremely good, Quite good, Better than average, Average, Below Average, Quite bad, Extremely bad."|2 weeks|The secondary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint|||Likert scale 1-7 (7= best)||Standard Deviation|Mean
2674539|NCT01454791|Primary|Pain Scale at 2 Weeks|0-10 subjective Likert scale for severity of injection site reaction associated pain. Zero is best and 10 is worst|2 weeks|The primary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint|||units on a scale||Standard Deviation|Mean
2674540|NCT01454791|Primary|Local Injection Site Reaction (0-6) Scale at Baseline, 2 Weeks|patients will complete a daily diary rating their reaction for elements including pain and inflammation or no reaction to all 6 elements listed on the local injection site reaction scale. Range of scores is 0-6 with zero best and 6 worst.|2 weeks|The primary outcome is looking at between-intervention differences at 2 weeks of intervention. Not a comparison at any other timepoint|||units on a scale||Standard Deviation|Mean
2674541|NCT01454778|Primary|Rutherford Classification of Peripheral Arterial Disease|"Evidence of stenosis of lower extremity as measured by the Rutherford Classification post revascularization. The ABI and Rutherford Classification will be assessed at 10 months post revascularization with a lower Rutherford score indicating a better outcome.~0 = Asymptomatic, 1 = Mild Claudication, 2 = Moderate Claudication, 3 = Severe Claudication, 4 = Ischemic Rest Pain, 5 = Minor Tissue Loss, 6 = Ulceration or Gangrene"|10 months||||units on a scale||Standard Deviation|Mean
2674542|NCT01454778|Secondary|Number of Serious Adverse Events||Up to 19 months||||Number of SAE's|||Number
2674543|NCT01454778|Secondary|Freedom From Binary Restenosis||10 months||||percentage of participants|||Number
2674544|NCT01454778|Secondary|Freedom From Target Vessel Revascularization Event||up to 10 months||||percentage of participants|||Number
2674545|NCT01454778|Secondary|Freedom From Amputation Event||up to 10 months||||percentage of participants|||Number
2674546|NCT01454778|Primary|Evidence of Stenosis Lower Extremity Post Revascularization Using Ankle-Brachial Index Measurement at 10 Months|The Ankle-Brachial Index is calculated as a ratio of the ankle blood pressure and the arm blood pressure. The ABI and Rutherford Classification will be assessed at 10 months post revascularization|10 months||||ratio||Standard Deviation|Mean
2674567|NCT01454583|Primary|Efficacy of Hypertension Treatment on Diastolic Office Blood Pressure (DBP)|Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 1 year, the difference divided by the baseline value, multiplied by 100|Baseline and 2 years||||percent change||Standard Deviation|Mean
2674547|NCT01454739|Secondary|Participant's Assessment of Response (Excellent or Good Response) to rFVIIIFc Injections for the Treatment of Bleeding Episodes Using a 4-Point Scale|Using eDiary, participant received rating for treatment response to any bleeding episode (BE) using 4-point scale- 1=Excellent: Abrupt pain relief and/or improvement in signs of bleeding within approximately (approx.) 8 hours (h) after initial injection (inj.); 2=Good: Definite pain relief and/or improvement in signs of bleeding within approx. 8h after an injection, but possibly requiring more than 1 injection after 24-48h for complete resolution; 3=Moderate: Probable/slight beneficial effect within 8h after initial injection and requires more than 1 injection and 4=None: No improvement, or condition worsens within approx. 8h after initial injection. This assessment was to be made approx. 8 to 12h from time the injection was given to treat BE and prior to any additional doses of rFVIIIFc given for same bleeding episode. Percentages are based on the number of bleeding episodes for which a response (excellent or good) was provided for the first injection during the efficacy period.|Approximately 5 years|FAS was analyzed.Data was summarized by treatment regimen for participants from 997HA301/997HA307/997HA309 combined and by age cohort (<6 years and 6 to<12 years old) and treatment regimen for participants from 8HA02PED per planned analysis.Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.|||Injections|Injections||Count of Units
2674548|NCT01454739|Secondary|Physicians' Global Assessment of Participant's Response to rFVIIIFc Regimen Using a 4-Point Scale|Participants were assessed for response to their rFVIIIFc regimen using following 4-point scale: 1=Excellent:bleeding episodes responded to less than or equal to (<=)usual number of injections/dose of rFVIIIFc or rate of breakthrough bleeding during prophylaxis was <= that usually observed; 2=Effective: most bleeding episodes responded to same number of injections and dose, but some required more injections or higher doses, or there was minor increase in rate of breakthrough; 3=Partially Effective: bleeding episodes most often required more injections and/or higher doses than expected or adequate breakthrough bleeding prevention during prophylaxis required more frequent injections and/or higher doses and 4=Ineffective: routine failure to control hemostasis/hemostatic control require additional agents. Total number of scale responses =total count of scale responses for all participants; multiple responses per participant including those at scheduled and unscheduled visits are counted.|Approximately 5 years|FAS- all participants who received at least 1 dose of rFVIIIFc. Data was summarized by treatment regimen for participants from 997HA301/997HA307/997HA309 combined and study from 8HA02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.|||Responses|Responses||Count of Units
2674549|NCT01454739|Secondary|Annualized rFVIIIFc Consumption (International Units Per Kilogram [IU/kg])|Annualized consumption = (total international unit per kilogram [IU/kg] of study treatment received during the efficacy period / total number of days during the efficacy period) multiplied by 365.25. Efficacy period reflects sum of all intervals of time during which participants were treated with rFVIIIFc per treatment regimen excluding major and minor surgical/rehabilitation periods and large injection intervals. Annualized consumption was summarized by treatment regimen for participants from studies 997HA301/997HA307/997HA309 combined and by age cohort (<6 years and 6 to <12 years old) and treatment regimen for participants from Study 8HA02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.|Approximately 5 years|FAS included all participants who received at least 1 dose of rFVIIIFc. Here 'n' (number analyzed) signifies number of participants who were analyzed in each treatment regimen, for each arm, respectively.|||IU per kilogram per year||Inter-Quartile Range|Median
2674550|NCT01454739|Secondary|Total Number of Exposure Days (EDs)|An exposure day is a 24-hour period in which one or more rFVIIIFc injections are given. The total number of days of exposure to rFVIIIFc were summarized by treatment regimen for participants from studies 997HA301/997HA307/997HA309 combined and by age cohort (<6 years and 6 to <12 years old) and treatment regimen for participants from Study 8HA02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.|Approximately 5 years|Safety Analysis Set included participants who received at least 1 dose of rFVIIIFc in study 8HA01EXT. Here 'n' (number analyzed) signifies number of participants who were analyzed in each treatment regimen, for each arm, respectively.|||days||Full Range|Median
2674551|NCT01454739|Secondary|Annualized Spontaneous Joint Bleeding Episodes|Bleeding episodes were classified as spontaneous if participant records a bleeding event when there is no known contributing factor such as definite trauma/antecedent strenuous activity. In addition, location of bleed (joint, internal, skin/mucosa or muscle) were collected. Annualized spontaneous joint bleeding episodes=(Number of spontaneous joint bleeding episodes during efficacy period (EP)/number of days during EP)*365.25. EP reflects sum of all intervals of time during which participants were treated with rFVIIIFc per treatment regimen excluding major and minor surgical/rehabilitation periods and large injection intervals. Bleeding episodes were summarized by treatment regimen for participants from studies 997HA301/997HA307/997HA309 combined and by age cohort (<6 years and 6 to <12 years old) and treatment regimen for participants from Study 8HA02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.|Approximately 5 years|FAS included all participants who received at least 1 dose of rFVIIIFc. Here 'n' (number analyzed) signifies number of participants who were analyzed in each treatment regimen, for each arm, respectively.|||episodes per participant per year||Inter-Quartile Range|Median
2674552|NCT01454739|Secondary|Annualized Bleeding Rate (ABR)|ABR is annualized number of bleeding episodes per participant per year. Bleeding episodes were classified as spontaneous if participant records bleeding event when there is no known contributing factor such as definite trauma/antecedent strenuous activity and as traumatic if participant records bleeding event when there is known reason for bleed. ABR=(Number of bleeding episodes during efficacy period (EP)/number of days during EP)*365.25. EP reflects sum of all intervals of time during which participants were treated with rFVIIIFc per treatment regimen excluding major and minor surgical/rehabilitation periods and large injection intervals. ABR was summarized by treatment regimen for participants from studies 997HA301/997HA307/997HA309 combined and by age cohort (<6 years and 6 to <12 years old) and treatment regimen for participants from Study 8HA02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.|Approximately 5 years|Full Analysis Set (FAS) included all participants who received at least 1 dose of rFVIIIFc. Here 'n' (number analyzed) signifies number of participants who were analyzed in each treatment regimen, for each arm, respectively.|||episodes per participant per year||Inter-Quartile Range|Median
2674553|NCT01454739|Primary|Number of Participants With Any Positive Inhibitor Development|An inhibitor test result greater than or equal to (>=) 0.6 Bethesda units per milliliter (BU/mL), identified and confirmed by re-testing of a second sample obtained within 2 to 4 weeks, was considered positive. Both tests were to be performed using the Nijmegen-modified Bethesda Assay by the central laboratory. Data was summarized by treatment regimen for participants from 997HA301/997HA307/997HA309 combined and by age cohort (<6 years and 6 to <12 years old) and treatment regimen for participants from 8HA02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.|Approximately 5 years|Safety analysis set included participants who received at least 1 dose of Recombinant Human Coagulation Factor VIII Fusion Protein(rFVIIIFc) in study 8HA01EXT.|||Participants|||Count of Participants
2674554|NCT01454726|Primary|Change in Dizziness Handicap Inventory (DHI) Questionnaire Score|dizziness Handicap Inventory (DHI) evaluates the self-perceived handicapping effects imposed by vestibular system disease. We employed the final version of DHI, which contains 25 items including 7 physical questions, 9 functional questions and 9 emotional questions. DHI has a total score of 100 points (4 points for each item). Higher scores indicate more severe handicap. Thus the maximum score for DHI is 100, while the minimum core is 0.|0 and 24 hours|Among the 27 participants enrolled in the study, one participant quitted the study before treatment application. Twenty-six patients fulfilled all the procedures and were eligible for the full analysis.|||units on a scale||Standard Deviation|Mean
2674555|NCT01454596|Secondary|Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|51 dys Grp A, Cohort 1; Cohort 2:68 dys; Cohort 3:40 dys; Grp B, Cohort 1:67 dys; Cohort 2:48 dys; Cohort 3:55 dys; Cohort 4: 46 dys; Cohort 5:147 dys; C. Ster/No Ster Grp, Cohort 6:12 mos, 26 dys; Cohort 7:11 mos, 18 dys; Cohort 8:7 dys; Cohort 9:70 dys.||||Participants|||Count of Participants
2674556|NCT01454596|Secondary|Circulating Chimeric Antigen Receptor (CAR+) Cells in Peripheral Blood at 1 Month Post Treatment|CAR and vector presence were quantitated in peripheral blood mononuclear cell (PBMC) samples using established polymerase chain reaction (PCR) techniques|1 month post transplant|Only 1/3 participants were evaluable in cohort 6 at one month, and 2/3 participants were evaluable in cohort 7 at one month. Due to a low number of events, nonspecific binding of anti-human Fab’, and slow recovery of the lymphocyte compartment, the data reported should be interpreted with caution.|||K/µL||Full Range|Median
2674557|NCT01454596|Secondary|Number of Patients With an Objective Response|Objective response was assessed by comparison with baseline dynamic contrast enhanced magnetic resonance imaging with perfusion using Neuro-oncology Working Group proposed guidelines. Complete Response is disappearance of all measurable and non-measurable disease for at least 4 weeks. Partial Response is >/= 50% decrease in lesions for at least 4 weeks. Stable Disease does not meet the criteria for complete response, partial response or progression and requires stable lesions compared with baseline. Progression is >/= 25% increase in lesions.|4 weeks after cell infusion and monthly as feasible up to 12 months||||Participants|||Count of Participants
2674558|NCT01454596|Primary|Progression Free Survival|Progression was assessed by the Response Assessment in Neuro-Oncology (RANO) criteria and is defined as the circumstance when the magnetic resonance imaging (MRI) scan is ranked -2 (definitely worse) or -3 (development of a new lesion).|Time from the date of registration to the date of first observation of progressive disease up to 6 months after end of treatment|Combined steroids/no steroids, Cohort 8: participant experienced a treatment-related mortality (TRM).|||months||Inter-Quartile Range|Median
2674559|NCT01454596|Primary|Number of Treatment Related Adverse Events|Aggregate of all adverse events ≥Grade 3 that are possibly, probably, and definitely related to treatment. Adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). Per CTCAE, Grade 3 adverse events are severe, Grade 4 is life threatening, and Grade 5 is death.|From 4 weeks after cell infusion up to 77 days||||adverse events|||Number
2674560|NCT01454583|Secondary|Influence of Anti-hypertensive Treatment on Renal Function|Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline|3 years follow up||||percentage of patients|||Number
2674561|NCT01454583|Secondary|Influence of Anti-hypertensive Treatment on Renal Function|Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline|2 years follow up||||percentage of patients|||Number
2674562|NCT01454583|Secondary|Influence of Anti-hypertensive Treatment on Renal Function|Improvement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline|1 year follow up||||percentage of patients|||Number
2674563|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 3 years, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h.|Baseline and 3 years||||percent change||Standard Deviation|Mean
2674564|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 3 years, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h.|Baseline and 3 years||||percent change||Standard Deviation|Mean
2674565|NCT01454583|Primary|Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP)|Relative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 3 years, the difference divided by the baseline value, multiplied by 100|Baseline and 3 years||||percent change||Standard Deviation|Mean
2674570|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 2 years, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h.|Baseline and 2 years||||percent change||Standard Deviation|Mean
2674571|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 2 years, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h.|Baseline and 2 years||||percent change||Standard Deviation|Mean
2674572|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 1 year, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h.|Baseline and 1 year||||percent change||Standard Deviation|Mean
2674573|NCT01454583|Secondary|Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement|Relative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 1 year, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h.|Baseline and 1 year||||percent change||Standard Deviation|Mean
2674574|NCT01454583|Secondary|Adverse Events|Percentage of participants that experienced at least one adverse event during the three years of observation period|3 years follow up||||percentage of patients|||Number
2674575|NCT01454583|Secondary|Adverse Events|Percentage of participants that experienced at least one adverse event during the first two years of observation period|2 years follow up||||percentage of patients|||Number
2674576|NCT01454583|Secondary|Adverse Events|Percentage of participants that experienced at least one adverse event during the first year of observation period|1 year follow up||||percentage of patients|||Number
2674577|NCT01454583|Secondary|Therapy Adherence Regarding Drug Treatment|Percentage of patients not having changed the therapy group after 3 years (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline)|Baseline and 3 years||||percentage of patients|||Number
2674578|NCT01454583|Secondary|Therapy Adherence Regarding Drug Treatment|Percentage of patients not having changed the therapy group after 2 years (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline)|Baseline and 2 years||||percentage of patients|||Number
2674579|NCT01454583|Secondary|Therapy Adherence Regarding Drug Treatment|Percentage of patients not having changed the therapy group after 1 year (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline)|Baseline and 1 year||||percentage of patients|||Number
2674580|NCT01454583|Primary|Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)|Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 1 year, the difference divided by the baseline value, multiplied by 100|baseline and 1 year||||percent change||Standard Deviation|Mean
2674581|NCT01454531|Secondary|Change in Immediate Cutaneous Response to Phleum Pratense|Wheal size provoked after prick test with 4, 20 and 100 µg/ml Phl p 5 allergen extracts analysed by Parallel Line Assay. Cutaneous Tolerance Index (CTI) is the factor it is necessary to multiply the extract concentration by after SCIT (V6) to obtain the same response in terms of wheal area as at baseline (V1). CTI, being an index, is a dimensionless measure. A CTI of 1 indicates no change in skin sensitivity while if higher than 1 a decrease in skin sensitivity (it would be needed a more concentrated allergen extract at V6 to elicit the same skin response as at V1|baseline (visit 1) and at 6 weeks (visit 6)|Participants in which results of the Parallel Line Assay are valid|||CTI, Cutaneous Tolerance Index||95% Confidence Interval|Mean
2674582|NCT01454531|Secondary|Change in Phleum Pratense Specific IgG4||baseline (visit 1) and at 6 weeks (visit 6)|Number of subject with valid data in visit 1 and visit 6|||mgA/l||Standard Deviation|Mean
2674583|NCT01454531|Secondary|Change in Phleum Pratense Specific IgE-blocking Factor|"IgE-blocking factor measures the amount of IgE bound to the allergen in the presence of allergen-competing factors present in the serum of a subject treated with allergen immunotherapy. The test is based in a double IgE measurement, an ordinary assay and an assay in the presence of competing components and takes the form of:~IgE blocking factor = 1 - (Competitive IgE/Ordinary IgE). Theoretical limits are from 0 (no IgE blocked) to 1 (all IgE blocked) and, being a ratio, is a dimensionless measure"|baseline (visit 1) and at 6 weeks (visit 6)||||arbitrary units||Standard Deviation|Mean
2674584|NCT01454531|Secondary|Frequency of Subjects With Local Adverse Reaction|Frequency of patients with local adverse reactions|6 weeks||||participants|||Number
2674585|NCT01454531|Secondary|Frequency of Subjects With Systemic Reactions|Frequency of patients with systemic reactions, based on EAACI classification: Grade I (mild systemic reaction) to IV (anaphylactic shock)|6 weeks||||participants|||Number
2674586|NCT01454531|Primary|Frequency of Subjects With Adverse Drug Reactions|Frequency of patients with adverse reactions, local or systemic|6 weeks|Subjects treated|||participants|||Number
2674587|NCT01454505|Primary|Mean Change From Baseline in Nasal Congestion Over a 6-hour Period in the EEC at Day 5|Stage B: Nasal congestion was assessed by the subject before entering the EEC and at 14 timepoints over a 6-hour period after entering the EEC. Nasal congestion was scored on a scale from 0-3, where 0=none and 3=severe. Baseline EEC was conducted up to 21 days prior to the 5-day treatment period.|Baseline (pretreatment), Day 5|Stage B: This reporting group includes all randomized subjects who satisfied inclusion/exclusion criteria and had EEC data at baseline and Day 5, per protocol.|||Units on a scale||Standard Deviation|Mean
2674978|NCT01451411|Secondary|Change From Baseline in Effective Water Clearance (EWC) Every 12 Hours||Baseline, Hours 12, 24, 36 and 48|The protocol specifies that calculations for this endpoint were to be derived by the statistical team. Due to the terminated status of the study, a statistical team was not employed and calculations to determine this variable were not performed.||||||
2674588|NCT01454505|Secondary|Mean Change From Baseline in Total Nasal Symptom Scores (TNSS) Over a 6-hour Period in the EEC at Day 5|Stage B: Nasal symptoms were assessed by the subject before entering the EEC and at 14 timepoints over a 6-hour period after entering the EEC. TNSS score (0-12) was a sum of scores for nasal congestion, sneezing, itchy nose, and runny nose scores, each individually assessed on a 0 to 3 scale, where 0=none and 3=severe. Baseline EEC was conducted up to 21 days prior to the 5-day treatment period.|Baseline (pretreatment), Day 5|Stage B: This reporting group includes all randomized subjects who satisfied inclusion/exclusion criteria and had EEC data at baseline and Day 5, per protocol.|||Units on a scale||Standard Deviation|Mean
2674589|NCT01454505|Primary|Number of Adverse Events in Stage A|Adverse events, including serious adverse events and deaths, were reported regardless of test article relationship.|Day 1|This reporting group includes all subjects exposed to test article during Stage A.|||Adverse Events|||Number
2674590|NCT01454414|Secondary|Seroconversion Against a Tick-borne Illness|We will define seroconversion as one in which there is a 4-fold change in Immunoglobulin G class antibody titer between sera at enrollment, sera obtained after one year and/or sera obtained at study's end or between acute and convalescent sera for participants developing an acute illness. The antigens that will be used in the serologic assays include Ehrlichia chaffeensis (which would also detect antibodies to E. ewingii and Anaplasma phagocytophilum) and Rickettsia rickettsii (which would also detect antibodies to other spotted fever group rickettsiae).|Upon enrollment, after the first year, and after the second year|||||||
2674591|NCT01454414|Primary|Work Related Tick Bites|Tick bites are defined as ticks attached to or embedded in the skin|Weekly for two years||||tick bites|||Number
2674592|NCT01454401|Primary|Ulcer Healing Within 20 Weeks|Number of the patients achieved complete epithelialization at 20 weeks in the ITT population and in the PP population.|20 weeks|Number of the patients achieved complete epithelialisation at 20 weeks in the ITT population and in the PP population|||participants|||Number
2674593|NCT01454401|Secondary|Ulcer Healing Within 12 Weeks.|Number of the patients achieved complete epithelialisation at 12 weeks (ITT population) and the percentage respectively in the PP population|12 weeks|Complete epithelialisation was achieved in 15 patients (34%) in ITT population and 38% in the PP population|||participants|||Number
2674594|NCT01454362|Secondary|Product Satisfaction|Product satisfaction: Ratings of product satisfaction (when compared to cigarettes). Rating 0-4, with higher value indicating higher satisfaction ratings.|24 hours|Reporting group|||units on a scale||Standard Deviation|Mean
2674595|NCT01454362|Secondary|Airway Sensations|Sensory effects: Measure of airway sensations (throat and chest). Mean enjoyment score (rating 0-4), higher the score indicating increased enjoyment.|24 hours|Reporting group|||units on a scale||Standard Deviation|Mean
2674596|NCT01454362|Secondary|Reinforcing Effects of Smoking|Modified Cigarette Evaluation Questionnaire (mCEQ): Measure of reinforcing effects of smoking (pleasant feeling). Mean pleasant feeling from using product (rating 0-4). Higher value indicating the higher rating of pleasure.|24 hours|Reporting group|||units on a scale||Standard Deviation|Mean
2674597|NCT01454362|Secondary|Change in Salivary Cotinine Levels After 24-hour Use.|"Cotinine is a measure sensitive enough to detect effects of a switch to different nicotine products and salivary cotinine was shown to be dependent on nicotine mouth exposure.~The results show the mean change in salivary cotinine in each study arm (all study participants)."|24 hours|Reporting group|||ng/ml||Standard Deviation|Mean
2674598|NCT01454362|Primary|Comparison of E-C and Inhalator in Effects on Withdrawal Over 24 Hours of Use.|"Mood and Physical Symptoms Scale (MPSS): Measure of severity of urges to smoke and tobacco withdrawal symptoms.~A five-point scale is used to rate 'How much of the time have you felt the urge to smoke in the past week?' ((1) 'not at all' to (5) 'almost all of the time') and 'How strong have the urges been?' ('no urges' to 'very strong'). Clients also rate depression, irritability, restlessness, hunger, poor concentration, poor sleep at night, and anxiety during the past week ((1)=not at all to (5)=extremely). The combined score to questions on depression, irritability, restlessness, hunger, and poor concentration are averaged to give the MPSS score. A higher score means a more severe rating of withdrawal.~The primary outcome is a change in MPSS score between baseline and 24 hours (value at 24 hours minus value at baseline). Therefore, a smaller change in MPSS score represents a smaller increase in tobacco withdrawal symptoms."|24 hours|Reporting group|||units on a scale||Standard Deviation|Mean
2674599|NCT01454284|Secondary|Rapid Assessment of Physical Activity (RAPA)|The RAPA questionnaire assesses the level and intensity of physical activity of adult participants. It contains 2 subscales: RAPA 1 (Aerobic) and RAPA 2 (Strength and Flexibility). RAPA 1 contains 7 questions regarding the participant's amount and intensity of physical activity, allowing each participant's aerobic activity level to be categorized as sedentary, underactive, light activity, regular underactive, or active. RAPA 2 contains 2 questions regarding participants' physical activities that increase strength and improve flexibility. Each participant's strength and flexibility activity level is then categorized as neither strength nor flexibility activity, either strength or flexibility activity (not both), both strength and flexibility activity. The percentage of participants in each RAPA 1/2 category is presented and was calculated by dividing the number of participants in each RAPA 1/2 category by the total number of participants analyzed, multiplied by 100.|52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable RAPA data.|||percentage of participants|||Number
2674600|NCT01454284|Secondary|Adult Low Blood Sugar Survey|Low Blood Sugar Survey (LBSS) (also referenced as Hypoglycemia Fear Survey - II [HFS-II]) is a questionnaire that measures 1) behaviors to avoid hypoglycemia and its negative consequences (15 items) and 2) worries about hypoglycemia and its negative consequences (18 items). Responses are made on a 5-point Likert-type scale where 0 = Never and 4 = Always. Total score is the sum of all items (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using MMRM adjusting for treatment, baseline HbA1c (≤8.5% and >8.5%), country, baseline prior basal insulin therapy (insulin glargine/detemir/other), visit, treatment-by-visit interaction, and baseline LBSS score as the fixed effects and participant as the random effect.|26 weeks and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable LBSS data at both baseline and post-baseline.|||units on a scale||Standard Error|Least Squares Mean
2674979|NCT01451411|Secondary|Number of Subjects With Confirmed > 6 mEq/L Increase From Baseline in Serum Sodium or a Confirmed Normal Serum Sodium Level (Greater Than or Equal to 135 mEq/L)||baseline and 48 hours||||participants|||Number
2674601|NCT01454284|Secondary|European Quality of Life -5 Dimension (EQ-5D-3L)|The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three-level scale of 1-3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using an ANCOVA adjusting for treatment, baseline HbA1c (≤8.5% and >8.5%), country, baseline prior basal insulin therapy (insulin glargine/detemir/other), and baseline EQ-5D-3L score as covariates.|up to 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable EQ-5D-3L data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2674602|NCT01454284|Secondary|Insulin Treatment Satisfaction Questionnaire|Insulin Treatment Satisfaction Questionnaire (ITSQ) is a validated measure containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Convenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, and Insulin Delivery Device. Data are transformed to a scale of 0-100, where higher scores indicate better treatment satisfaction. LS means were calculated using an ANCOVA model adjusting for treatment, baseline HbA1c (≤8.5% and >8.5%), country, and baseline prior basal insulin therapy (insulin glargine/detemir/other) as fixed effects and baseline ITSQ scores as a covariate.|up to 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable ITSQ data at both baseline and post-baseline. Missing endpoints were imputed with the LOCF method.|||units on a scale||Standard Error|Least Squares Mean
2674603|NCT01454284|Secondary|Basal, Meal Time, and Total Insulin Dose Per Body Weight|Basal insulin dose, meal-time insulin dose (short-acting bolus dose), and total insulin dose were calculated based on the dose during the last 7 days prior to the post-treatment visit or last 3 days prior to the randomization visit. LS means were calculated using a constrained Longitudinal Data Analysis (cLDA) model adjusting for indicator variables of each treatment group at each postbaseline visit and stratification variables (baseline HbA1c [≤8.5% and> 8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], and baseline prior basal insulin therapy [insulin glargine/detemir/ other]) as fixed effects.|26 weeks and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable insulin dose data.|||units/weight/day||Standard Error|Least Squares Mean
2674604|NCT01454284|Secondary|Percentage of Participants With Change in Anti-LY2605541 Antibodies|The percentage of participants with anti-LY2605541 treatment-emergent antibody response (TEAR) is summarized. TEAR is defined as change from baseline to post-baseline in the anti-LY2605541 antibody level either from undetectable to detectable, or from detectable to the value with at least 130% relative increase from baseline.|26 weeks, 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable anti-LY2605541 antibody data at baseline and post-baseline.|||percentage of participants|||Number
2674605|NCT01454284|Secondary|Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C), and Total Cholesterol|Concentrations of cholesterol, HDL-C, and LDL-C, and triglycerides are presented. LS means were calculated using MMRM adjusting for stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L), except for the LDL-C outcome variable], prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment, treatment-by-visit interaction, and baseline value of corresponding lipid outcome variable as the fixed effects and participant as a random effect.|26 weeks and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable lipid data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2674606|NCT01454284|Secondary|0300 Hours Blood Glucose (BG) to Fasting BG Excursion|Results of a 0300-hour to pre-morning meal (FBG) excursion are presented (only excursions within a single SMBG profile are included). LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline excursion as the fixed effects and participant as the random effect.|26 weeks and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2674607|NCT01454284|Secondary|Intra-participant Variability of Fasting Blood Glucose (FBG)|FBG was measured by SMBG. Between-day glucose variability is measured by the standard deviation (SD) of FBG. LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline SD of FBG as the fixed effects and participant as the random effect.|26 weeks and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FBG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2674608|NCT01454284|Secondary|Fasting Blood Glucose (by Participant Self Monitored Blood Glucose Readings)|Fasting blood glucose (FBG) was measured by SMBG pre-morning meal. LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline FBG as the fixed effects and participant as the random effect.|26 weeks and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FBG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2674609|NCT01454284|Secondary|Fasting Serum Glucose (by Laboratory Measurement)|Fasting serum glucose (FSG) is measured in blood before the morning meal. LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.|26 weeks and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable FSG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2674610|NCT01454284|Secondary|9 Point Self-monitored Blood Glucose (SMBG)|9-point SMBG profiles were obtained over 2 days within the week prior to Weeks 0, 4, 12, 26, 39, and 52. SMBG measurements were taken at 9 time points: pre-morning meal, 2 hours post-morning meal, pre-midday meal, 2 hours post-midday meal, pre-evening meal, 2 hours post-evening meal, bedtime, at approximately 0300 hours, and the subsequent morning prior to the morning meal. LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline BG values as the fixed effects and participant as the random effect.|26 weeks and 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable SMBG data at both baseline and post-baseline.|||mg/dL||Standard Error|Least Squares Mean
2674611|NCT01454284|Secondary|Change in Body Weight|LS means were calculated using MMRM adjusting for treatment, stratification factors (baseline HbA1c [≤8.5% and >8.5%], country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline body weight as fixed effects and participant as the random effect.|Baseline, 26 weeks, 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable body weight data at both baseline and post-baseline.|||kilograms (kg)||Standard Error|Least Squares Mean
2674612|NCT01454284|Secondary|Percentage of Participants With Nocturnal Hypoglycemic Events|Hypoglycemic episodes are defined as events associated with the reported signs and symptoms of hypoglycemia and/or a BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with nocturnal hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.|Baseline through 26 weeks, Baseline through 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||percentage of participants|||Number
2674613|NCT01454284|Secondary|Nocturnal Hypoglycemia Rates|Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or a documented BG concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. Group mean rates of nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline nocturnal hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.|Baseline through 26 weeks, Baseline through 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||events/participant/30 days||Standard Error|Mean
2674614|NCT01454284|Secondary|Percentage of Participants With HbA1c Less Than 7.0% and Without Nocturnal Hypoglycemia|Hypoglycemic episodes are defined as events associated with reported signs and symptoms of hypoglycemia and/or a documented blood glucose concentration of ≤70 mg/dL (3.9 mmol/L). A nocturnal hypoglycemic event occurred between bedtime and waking and between the time points of 10:00 PM and 10:00 AM. The percentage of participants was calculated by dividing the number of participants with HbA1c <7.0% without nocturnal hypoglycemia by the total number of participants analyzed, multiplied by 100.|up to 26 weeks, up to 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data. Missing endpoints were imputed with the LOCF method, using only post-baseline data.|||percentage of participants|||Number
2674615|NCT01454284|Secondary|Percentage of Participants With HbA1c Equal to or Less Than 6.5% and Less Than 7.0%|The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.|up to 26 weeks, up to 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.|||percentage of participants|||Number
2674616|NCT01454284|Secondary|Percentage of Participants With Total Hypoglycemic Events|Hypoglycemic episodes are defined as events that are associated with the reported signs and symptoms of hypoglycemia and/or documented BG concentrations of ≤70 mg/dL (3.9 mmol/L). The percentage of participants was calculated by dividing the number of participants with hypoglycemic episodes by the total number of participants analyzed, multiplied by 100.|Baseline through 26 weeks, Baseline through 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||percentage of participants|||Number
2674617|NCT01454284|Secondary|Total Hypoglycemia Events|Hypoglycemic episodes are defined as events which are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). Group mean rates of total hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models (number of episodes = treatment + baseline total hypoglycemia rate, with log [exposure in days/30] as an offset variable). Group mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants.|Baseline through 26 weeks, Baseline through 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable data at both baseline and post-baseline.|||episodes/participant/30 days||Standard Error|Mean
2674618|NCT01454284|Secondary|Change From Baseline to 52 Weeks in HbA1c|HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. LS means were calculated using MMRM adjusting for treatment, stratification factors (country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.|Baseline, 52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
2674709|NCT01453374|Primary|Incidence of Subject Re-arrest|Subjects were considered to have had a re-arrest for any new crime or probation/parole violation if the subject had re-arrest records in the official criminal justice records and/or via self-report.|7 months|All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data|||participants re-arrested|||Number
2674619|NCT01454284|Secondary|Hemoglobin A1c (HbA1c)|HbA1c is a test that measures a participant's average blood glucose level over the past 2 to 3 months. LS means were calculated using MMRM adjusting for treatment, stratification factors (country, baseline LDL-C [<100 mg/dL (2.6 mmol/L) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.|26 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
2674620|NCT01454284|Primary|Hemoglobin A1c (HbA1c)|HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, stratification factors (country, baseline low density lipoprotein cholesterol [LDL-C] [<100 milligrams/deciliter (mg/dL) (2.6 millimoles/liter [mmol/L]) and ≥100 mg/dL (2.6 mmol/L)], baseline prior basal insulin therapy [insulin glargine/detemir/other]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects and participant as the random effect.|52 weeks|Participants who were randomized, had at least 1 dose of study medication, and had evaluable HbA1c data at both baseline and post-baseline.|||percentage of HbA1c||Standard Error|Least Squares Mean
2674621|NCT01454258|Primary|Number of Different Substitution Solutions Administered||24h|Surgical patients from 10 hospitals over a period of 13 months|||participants|||Number
2674622|NCT01454102|Secondary|Progression-Free Survival Rate (PFSR) at Week 24|"Progression-Free Survival (PFS) was defined as the time from the date of first dose of study medication to the date of first disease progression or death, if death occurred within 100 days of the final dose of study drug. Among participants without previous RECIST-defined progression, participants who died beyond 100 days and those who remained alive were censored at the last tumor assessment date (before subsequent therapy).~PFSR at week 24 was defined as the proportion of subjects remaining progression free and surviving at 24 weeks. The proportion was calculated by the product-limit method (Kaplan-Meier estimate), which takes into account censored data, and expressed as a percentage."|24 weeks|All treated participants|||Percentage of participants||95% Confidence Interval|Number
2674623|NCT01454102|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of all treated participants who achieved a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria as per investigator assessment. This proportion was multiplied by 100 and expressed as a percentage. BOR was defined as the best response designation recorded between the date of randomization and the date of progression, or the date of subsequent anticancer therapy, whichever occurred first. CR or PR determinations included in the BOR assessment were confirmed by a second scan at least 4 weeks after the criteria for responses were first met. For participants without progression or subsequent therapy, all available response designations contributed to the BOR determination. For participants who continued treatment beyond progression, the BOR was determined based on response designations recorded up to the time of the initial progression.|From first dose until date of progression or subsequent anti-cancer therapy (assessed up to July 2016, approximately 55 months)|All treated participants|||Percentage of participants||95% Confidence Interval|Number
2674624|NCT01454102|Primary|Number of Participants With Abnormalities in Selected Thyroid Clinical Laboratory Tests|"The number of subjects with selected thyroid laboratory abnormalities is reported. FT3 and FT4 test abnormalities were considered for a 2-week window after the abnormal TSH test date.~TSH= thyroid-stimulating hormone; FT3= Free T3; FT4= Free T4; LLN= lower limit of normal; ULN= upper limit of normal"|From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months)|All treated participants with baseline and post-baseline measurements|||Participants|||Count of Participants
2674625|NCT01454102|Primary|Number of Participants With Abnormalities in Selected Hepatic Clinical Laboratory Tests|"The number of subjects with selected hepatic laboratory abnormalities is reported.~AST= aspartate aminotransferase; ALT= alanine aminotransferase; ULN= upper limit of normal."|From first dose to 30 days following last dose of study drug (assessed up to July 2016, approximately 55 months)|All treated participants with baseline and post-baseline measurements|||Participants|||Count of Participants
2674626|NCT01454102|Primary|Number of Participants Who Experienced Selected Adverse Events|"The number of participants who experienced an AE of interest due to any cause is presented. Endocrine, Gastrointestinal, Hepatic, Pulmonary, Renal, Skin, and~Hypersensitivity/Infusion select AEs were identified that are potentially associated with the use of nivolumab, based on the following 4 guiding principles:~AEs that may differ in type, frequency, or severity from AEs caused by non-immunotherapies~AEs that may require immunosuppression (eg, corticosteroids) as part of their management~AEs whose early recognition and management may mitigate severe toxicity~AEs for which multiple event terms may be used to describe a single type of AE, thereby necessitating the pooling of terms for full characterization."|From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)|All treated participants|||Participants|||Count of Participants
2674627|NCT01454102|Primary|Number of Participants Who Experienced Serious Adverse Events (SAE), Adverse Events (AE) Leading to Discontinuation, or Death|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling.|From first dose to 30 days after the last dose of study drug (assessed up to July 2016, approximately 55 months)|All treated participants|||Participants|||Count of Participants
2674628|NCT01454076|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib||Arm 1:Days 1, 15 and Arm 5:Day 6 pre-dose and at multiple time points(up to 264 hrs)post-dose;Arm 2, 3:Days 1,15 pre-dose and at multiple time points(up to 216 hrs)post-dose;Arm 4:Day 8 pre-dose and at multiple time points(up to 168 hrs)post-dose|The PK-evaluable population included all participants who received protocol-specified dose in Cycle 1 without dose reductions/interruptions, did not receive any excluded concomitant medication during PK sampling, and had sufficient concentration-time data to permit estimation of PK parameters by noncompartmental analysis methods.|||hours||Full Range|Median
2674629|NCT01454076|Secondary|Percentage of Participants With Best Overall Response|Best overall response for a participant is best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 millimeter [mm]). No new lesions. Partial response (PR) was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease (SD) was defined as not qualifying for CR, PR, Progressive Disease (PD). An increase of >=20% from the nadir (or baseline, if it represents the point at which the sum of target disease was lowest) represents PD.|Baseline up to end of treatment (approximately 1.9 years)|The response-evaluable population included participants who had measurable disease at baseline, received at least 1 dose of any study drug, and had at least 1 postbaseline response assessment.|||percentage of participants||95% Confidence Interval|Number
2674630|NCT01454076|Secondary|Number of Participants With Clinically Significant Vital Sign Abnormalities||Cycle 1 Day 1 up to 30 days after last dose of study drug (Arm 1 and 5: Cycle 19 Day 45; Arm 2: Cycle 7 Day 45; Arm 3: Cycle 22 Day 45; Arm 4: Cycle 25 Day 45|The safety population included all participants who received at least one dose of any study drug.|||participants|||Number
2674631|NCT01454076|Secondary|Number of Participants With Clinically Significant TEAEs Related to Laboratory Abnormalities||Cycle 1 Day 1 up to 30 days after last dose of study drug (Arm 1 and 5: Cycle 19 Day 45; Arm 2: Cycle 7 Day 45; Arm 3: Cycle 22 Day 45; Arm 4: Cycle 25 Day 45|The safety population included all participants who received at least one dose of any study drug.|||participants|||Number
2674632|NCT01454076|Secondary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||Cycle 1 Day 1 up to 30 days after last dose of study drug (Arm 1 and 5: Cycle 19 Day 45; Arm 2: Cycle 7 Day 45; Arm 3: Cycle 22 Day 45; Arm 4: Cycle 25 Day 45)|The safety population included all participants who received at least one dose of any study drug.|||participants|||Number
2674633|NCT01454076|Primary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Ixazomib||Arm 1:Days 1, 15 and Arm 5:Day 6 pre-dose and at multiple time points(up to 264 hrs)post-dose;Arm 2, 3:Days 1,15 pre-dose and at multiple time points(up to 216 hrs)post-dose;Arm 4:Day 8 pre-dose and at multiple time points(up to 168 hrs)post-dose|The PK-evaluable population included all participants who received protocol-specified dose in Cycle 1 without dose reductions/interruptions, did not receive any excluded concomitant medication during PK sampling, and had sufficient concentration-time data to permit estimation of PK parameters by noncompartmental analysis methods.|||nanogram*hour per milliliter (ng*hr/mL)]||Standard Deviation|Geometric Mean
2674634|NCT01454076|Primary|Cmax: Maximum Observed Plasma Concentration for Ixazomib||Arm 1:Days 1, 15 and Arm 5:Day 6 pre-dose and at multiple time points(up to 264 hours[hrs])post-dose;Arm 2, 3:Days 1,15 pre-dose and at multiple time points(up to 216 hrs)post-dose;Arm 4:Day 8 pre-dose and at multiple time points(up to 168 hrs)post-dose|The pharmacokinetic (PK)-evaluable population included all participants who received protocol-specified dose in Cycle 1 without dose reductions/interruptions, did not receive any excluded concomitant medication during PK sampling, and had sufficient concentration-time data to permit estimation of PK parameters by noncompartmental analysis methods.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2674635|NCT01454063|Secondary|Ocular Pain VAS Score After Day of Surgery - Day 1|Pain VAS scores (where 0 = no pain and 100 = worst possible pain) after the day of surgery summarized by treatment arm and time-point.|One day|Number of subjects with scores at time point.|||units on a scale||Standard Deviation|Mean
2674636|NCT01454063|Secondary|Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade on Day 1|"The mean SOIS summarized by treatment arm and time point on Day 1 postoperatively. Ocular inflammation was evaluated by measuring the anterior chamber cell count and flare using a slit lamp biomicroscope. SOIS was calculated by adding the average of subject's anterior chamber cells and flare grades. The minimum SOIS was 0 (indicating absence of inflammation), whereas the maximum SOIS was 8.~Grading was as follows:~Anterior Chamber Cells: Grade None = 0/no cells; Grade Mild = +1/1-5 cells; Grade Moderate = +2/6-15 cells; Grade Severe = +3/16-30 cells; Grade Very Severe = +4/>30 cells.~Anterior Chamber Flare: Grade None = 0/no Tyndall effect; Grade Mild = +1/barely discernable Tyndall effect; Grade Moderate = +2/moderately intense Tyndall beam in anterior chamber; Grade Severe = +3/severely intense Tyndall beam; Grade Very Severe = +4/very severely intense Tyndall beam with a white and milky appearance to the aqueous"|One day|Subjects with score at time point.|||units on a scale||Standard Deviation|Mean
2674637|NCT01454063|Secondary|Best Corrected Visual Acuity (BVCA) Log Score on Day 1|Best-Corrected Visual Acuity (BCVA) summarized by the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity log score. For subjects without a score due to inability to read the ETDRS chart, the log score was imputed as 1.6 for the purpose of treatment comparisons. Subjects without a score because the manifest refraction was not completed were excluded from the analysis.|One day|Subject who could read well enough to obtain visual acuity score.|||Log score||Standard Deviation|Mean
2674638|NCT01454063|Secondary|Photophobia at Day 1 After Surgery (Ocular Pain and Symptoms Numerical Ordinal Scale [Numerical Rating System - NRS] Scores)|Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at Day 1 postoperatively|One day|Subjects with scores at time point.|||participants|||Number
2674639|NCT01454063|Secondary|Photophobia at 6 Hours After Surgery (Ocular Pain and Symptoms Numerical Ordinal Scale [Numerical Rating System - NRS] Scores)|Photophobia outcomes based on Ocular Pain and Symptoms Numerical Ordinal Scale (Numerical Rating System - NRS) at 6 hours postoperatively.|Six hours postoperatively|Subjects with scores at time point.|||participants|||Number
2674640|NCT01454063|Secondary|Mean Area-under-the-Curve Analysis of Ocular Pain Visual Analog Scale (VAS) Score Within 12 Hours Postoperatively|The primary analysis of the ocular pain VAS (where 0 = no pain and 100 = worst possible pain) was based on the mean area-under-the-curve (AUC). The AUC of the ocular pain VAS during 12 hours postoperatively was calculated by the trapezoidal rule in which the hour 11 was used to represent the time-point 10-12 hours. The mean AUC was defined as the AUC divided by the number of hours with ocular pain VAS results during the first 12 hours postoperatively.|12 hours|Subjects with scores at time points.|||units on a scale||Standard Deviation|Mean
2674641|NCT01454063|Primary|Mean Area-under-the-Curve (AUC) Analysis of Change From Baseline in Pupil Diameter (mm) During Surgery|"Change in pupil diameter over time from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment arm and time-point (every minute).~The primary analysis of the change in pupil diameter was based on the mean area-under-the-curve (AUC) pupil diameter change from baseline. First, the AUC of the pupil diameter from surgical baseline to wound closure was calculated using the trapezoidal rule. Second, the mean AUC was obtained by dividing the AUC by the total time of surgery. Third, the mean AUC of change from baseline was calculated by subtracting the baseline pupil diameter from the mean AUC."|from surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure)|Subjects with interpretable video images obtained during intraocular lens replacement (ILR) procedure.|||mm||Standard Deviation|Mean
2674642|NCT01453998|Primary|Concentrations for Anti-Pertussis Toxoid.||One month after the booster dose||2020-12-31|12/2020||||
2674643|NCT01453998|Primary|Concentrations for Anti-poliovirus Types 1, 2 and 3||One month after the booster dose||2020-12-31|12/2020||||
2674644|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-Pertussis Toxoid.||One month after the booster dose||2020-12-31|12/2020||||
2674645|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3.||One month after the booster dose||2020-12-31|12/2020||||
2674646|NCT01453998|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Days 0-30). (subjects enrolled after protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.|||Subjects|||Number
2674647|NCT01453998|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled after protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.|||Subjects|||Number
2674648|NCT01453998|Secondary|Number of Subjects Reporting Any Solicited General Symptoms|Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.|||Subjects|||Number
2674649|NCT01453998|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.|||Subjects|||Number
2674650|NCT01453998|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.|During the entire study period (Days 0-30). (subjects enrolled before protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.|||Subjects|||Number
2674651|NCT01453998|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.|Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled before protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.|||Subjects|||Number
2674652|NCT01453998|Secondary|Number of Subjects Reporting Any Solicited General Symptoms.|Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.|||Subjects|||Number
2674653|NCT01453998|Secondary|Number of Subjects Reporting Any Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with the booster vaccine administration documented.|||Subjects|||Number
2674664|NCT01453998|Primary|Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||IU/mL||95% Confidence Interval|Geometric Mean
2674654|NCT01453998|Secondary|Concentrations for Anti-PNE Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||µg /mL||95% Confidence Interval|Geometric Mean
2674655|NCT01453998|Secondary|Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes|A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||Subjects|||Number
2674656|NCT01453998|Secondary|Concentrations for Anti-PNE Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||µg /mL||95% Confidence Interval|Geometric Mean
2674657|NCT01453998|Secondary|Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.|A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||Subjects|||Number
2674658|NCT01453998|Primary|Concentrations for Anti-PRP Antibodies.|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||µg /mL||95% Confidence Interval|Geometric Mean
2674659|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP).|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||Subjects|||Number
2674660|NCT01453998|Primary|Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||IU/mL||95% Confidence Interval|Geometric Mean
2674661|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies|A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||Subjects|||Number
2674662|NCT01453998|Primary|Concentrations for Anti-PRP Antibodies|Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||µg /mL||95% Confidence Interval|Geometric Mean
2674663|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)|A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||Subjects|||Number
2674665|NCT01453998|Primary|Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.|A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).|Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied the booster protocol and for whom assay results were available for antibodies against at least one study vaccine antigen at the post-booster vaccination blood-sampling time point.|||Subjects|||Number
2674666|NCT01453946|Primary|Adverse Event|Any kind of adverse event|16 weeks|Safety analysis set|||Subjects|||Number
2674667|NCT01453946|Secondary|IMPACT 3|IMPACT-III - A QUALITY OF LIFE QUESTIONNAIRE FOR CHILDREN WITH INFLAMMATORY BOWEL DISEASE|12 weeks|Safety analysis set|||Score units||Standard Deviation|Mean
2674668|NCT01453946|Secondary|PCDAI|Pediatric Crohn's Disease Activity Index. The scale ranges from 0 (no activity) to 100 (high activity)|12 weeks|Full Analysis Set|||Scores on a scale||Standard Deviation|Mean
2674669|NCT01453894|Primary|Completion of a Fecal Occult Blood Test (FOBT)|This outcome will be categorized as Completed FOBT if a participant's chart has documentation of a completed FOBT screening test. Outcomes will be assessed by querying the electronic health record (EHR) for all participants.|within 6 months of randomization||||participants|||Number
2674670|NCT01453855|Primary|Mean Intraocular Pressure (IOP) at Week 2, Week 6, and Month 3 for Each Assessment Time Point (8 AM, 10 AM, and 4 PM)|As measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye and only the study eye was used in the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).|Week 2, Week 6, Month 3 (8 AM, 10 AM, 4 PM)|The intent-to-treat (ITT) analysis set included all patients who received study drug and completed at least 1 scheduled on-therapy study visit. In addition, no imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.|||millimeters mercury (mmHg)||Standard Error|Least Squares Mean
2674671|NCT01453725|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who discontinued study drug due to an AE were calculated for each part of the study. Participants may have discontinued study drug without discontinuing from the study.|Up to 16 weeks for Part 1; Week 16 through up to 48 weeks for Part 2|The APaT population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.|||Percentage of Participants|||Number
2674672|NCT01453725|Primary|Percentage of Participants Who Experienced at Least One Adverse Event (AE)|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who experienced at least one AE were calculated for each part of the study.|Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)|The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.|||Percentage of Participants|||Number
2674673|NCT01453725|Secondary|Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints Score at Week 16|Participants underwent MRI of the SI joints, without contrast, at Screening and Week 16 to assess the presence or absence of active inflammation of the SI joints. Scoring was based on 6 consecutive MRI slices through the SI joint. Each slice was divided into 4 quadrants. Each of the 48 quadrants was scored with respect to the presence of inflammation (0=no, 1=yes), yielding a maximum score of 48. Each slice was also assessed for the presence of a lesion exhibiting either intense signal or a depth >=1 cm anywhere within the SI joint of the 6 slices (0=no, 1=yes), yielding a maximum score of 24. Total SI joint scores could range from 0 to 72, with a higher score indicating more signs of disease.|Baseline and Week 16|The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1, who completed Part 1, and who had Baseline and Week 16 MRI SI joint measurements.|||Score on a Scale||Standard Deviation|Mean
2674674|NCT01453725|Secondary|Percentage of Participants Achieving ASAS Partial Remission at Week 16|ASAS partial remission was defined as a VAS score of less than 20 mm in each of the 4 domains of ASAS 20: participant global assessment, pain (total back pain), function and inflammation. The percentages of participants who achieved ASAS partial remission were calculated.|Week 16|The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1.|||Percentage of Participants|||Number
2674675|NCT01453725|Secondary|Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Week 16|The BASDAI is a summary of 6 participant-assessed 100-mm VAS for a) Fatigue, b) Spinal pain (overall), c) Peripheral arthritis, d) Enthesitis, e) Qualitative morning stiffness (intensity) and f) Quantitative morning stiffness (duration). Each VAS is measured as 0=none to 100=very severe, with a higher score indicating more severe symptoms. The BASDAI score is calculated as 0.2 time (a+b+c+d+[0.5 times e+f]) and can range from 0 to 100. The BASDAI 50 is defined as improvement by at least 50% from Baseline in the BASDAI score. The percentages of participants who achieved BASDAI 50 were calculated.|Week 16|The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1 and had a Baseline BASDAI assessement.|||Percentage of Participants|||Number
2674684|NCT01453413|Primary|Percent of Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose|The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are > +/-20% different than meter BG values when samples have BG >=75mg/dL or > +/- 15mg/dL different than meter BG values when samples have BG <75mg/dL, as measured by fingerstick CONTOUR®.|1 visit 15-20 minutes|Three subjects were excluded from analyses due to inconsistencies in responses to inclusion/exclusion questions(297-3=294). Eight subjects were excluded from BG analyses because they did not have both an estimated BG value and a meter result (294-8=286)|||percentage of subjects||95% Confidence Interval|Number
2674676|NCT01453725|Secondary|Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16|The ASAS consists of 4 domains: participant global assessment, total back pain, function (BASFI), and inflammation (mean of questions 5 and 6 of BASDAI). Each domain is measured on a 100-mm VAS from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 40 is a 40% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of >=40% from Baseline and an absolute improvement from Baseline of >=20 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a >=0% worsening and an absolute worsening of >=0 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 40 were calculated.|Week 16|The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1.|||Percentage of Participants|||Number
2674677|NCT01453725|Primary|Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16|The ASAS consists of 4 domains: participant global assessment, total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and inflammation (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 100-mm visual analog scale (VAS) from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of >=20% from Baseline and an absolute improvement from Baseline of >=10 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a >=20% worsening and an absolute worsening of >=10 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 20 were calculated.|Week 16|The Full-Analysis-Set (FAS) population consisted of all randomized participants who received at least one dose of study drug in Part 1.|||Percentage of Participants|||Number
2674678|NCT01453595|Primary|Objective Response Rate (ORR)|In patients with advanced clear cell RCC, progressing after prior first-line or second-line mTOR therapy. The determination of antitumor efficacy will be based on objective tumor assessments made according to the RECIST1.1.|1 year|ORR was only assessed for participants who completed the study, which were only 5 patients on Cohort -1|||participants|||Number
2674679|NCT01453569|Secondary|Change of Neuropsychiatric Inventory(NPI) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule|Neuropsychiatric Inventory (NPI) is a scale to obtain information on the presence of psychopathology in patient with brain disorders. The NPI was developed for application to patients with AD and other dementias, but it may be useful in the assessment of behavioral changes in other conditions. Twelve behavioral areas included in the NPI will be assessed in this trial: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety and elation/euphoria, et al. The total score ranges 0 to 120, the higher score indicates worse state of the AD patient. Change after 24wks treatmnt was calculated by the week 24 minus week 0 (baseline), and a negative change represents an improvement.|24 weeks|85, 84, 86 patients were enrolled, and 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. ananlysed were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.|||units on a scale||Standard Error|Mean
2674680|NCT01453569|Secondary|Change of Alzheimer's Disease Cooperative Study/Activities of Daily(ADCS-ADL) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule|Alzheimer's Disease Cooperative Study/Activities of Daily (ADCS-ADL) is a scale assessed the daily activties of AD patients after interviewed the caregiver. The scale mainly assess the eating, walking, writing, bathing and reading, et al of the subject. The total score ranges 0-78, the higher score indicate improvement in daily activities. Change after 24 wks treatment was calculated by the week 24 minus week 0 (baseline), and a positive change represents an improvement.|24 weeks|85, 84, 86 patients were enrolled, and 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. ananlysed were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.|||units on a scale||Standard Error|Mean
2674681|NCT01453569|Secondary|Change of Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule|Clinician's Interview-Based Impression of Change Plus(CIBIC-plus) is widely used in antidementia drug trials. It comprises Likert scales for disease severity and changes, and written accounts summarizing semistructured interviews evaluating behavior, cognition, and function. The results classified as 7 degrades as: Markedly improved, Moderately improved, Minimally improved, No change, Minimally worse, Moderately worse, and Markedly worse.|24 weeks||||participants|||Number
2674682|NCT01453569|Primary|Change of Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 After 24 Wks Treatment of Sodium Oligo-mannurarate Capsule|Alzheimer's Disease Assessment Scale-cognitive Subscale(ADAS-cog)/12 is the most popular cognitive testing instrument used in clinical trials. It consists of 12 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. The total score ranges 0-75, the higher score indicates more severity of the disease. Change after 24 wks treatment was calculated by the week 24 minus week 0 (baseline), and a negative change represents an improvement.|24 weeks|85, 84, 86 patients were enrolled, and 2, 8 and 3 subjects were excluded from FAS in placebo, 600 mg and 900 mg group respectively. So the case No. ananlysed were 83, 76, 83 for placebo, 600 mg and 900 mg group respectively.|||units on a scale||Standard Error|Mean
2674683|NCT01453413|Secondary|Percent of Subjects Outside a Second Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose|The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are > +/-15% different than meter BG values when samples have BG >=100 mg/dL or > +/- 15 mg/dL different than meter BG values when samples have BG <100 mg/dL, as measured by fingerstick CONTOUR®.|1 visit 15-20 minutes|Three subjects were excluded from analyses due to inconsistencies in responses to inclusion/exclusion questions(297-3=294). Eight subjects were excluded from BG analyses because they did not have both an estimated BG value and a meter result (294-8=286)|||percentage of subjects||95% Confidence Interval|Number
2674708|NCT01453374|Secondary|Incidence of Subject Re-incarceration|Subjects were considered to have had a re-incarceration, a sentence to jail and/or prison, if the subject had re-incarceration records in the official criminal justice records and/or via self-report.|7 months|All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data|||participants re-incarcerated|||Number
2674685|NCT01453387|Secondary|Percentage of Subjects With Clinical Benefit|Clinical benefit was to be confirmed by CR, PR or stable disease (SD) lasting at least 6 weeks (using RECIST v1.0) during treatment. CR: The disappearance of all target and non-target lesions and normalization of tumor marker level; PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started.|Every 6 Weeks until complete response or till data cut-off date 15 July 2013|The efficacy analysis set included all subjects who received at least 1(non-zero) dose of MSC2015103B and had a baseline tumor assessment.|||percentage of subjects|||Number
2674686|NCT01453387|Secondary|Percentage of Subjects With Overall Response|Overall response was to be confirmed by complete response (CR) or partial response (PR) using response evaluation criteria in solid tumours Version 1.0 (RECIST) during treatment. CR: The disappearance of all target and non-target lesions and normalization of tumor marker level; PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline.|Every 6 Weeks until complete response or till data cut-off date 15 July 2013|The efficacy analysis set included all subjects who received at least 1(non-zero) dose of MSC2015103B and had a baseline tumor assessment.|||percentage of subjects|||Number
2674687|NCT01453387|Secondary|Extracellular Signal-regulated Kinase (ERK) Phosphorylation Levels|ERK phosphorylation levels were to be assessed in peripheral blood mononuclear cells (PBMC) during the dose escalation|Schedule 1: Day 1: Pre-dose; Post-dose: 2, 4, 8, 24 hour; 48 or 72 hour; 48 or 96 hour, 168 hour; Day 15: Pre-dose; Schedule 2: Day 1: Pre-dose; Post-dose: 2, 8, 24, 48, 96 hour; Day 15: Pre-dose; Day 17: Pre-dose; Post-dose: 2, 8, and 24 hour|As the trial was terminated early due to administrative reason, it was decided as per Statistical Analysis Plan not to evaluate the biomarker data for this study.||||||
2674688|NCT01453387|Secondary|Apparent Volume of Distribution Associated to the Terminal Phase (Vz/f)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed.|Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1.|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and who provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. n signifies the number of subjects evaluable for the particular timepoint."|||Liter||Full Range|Geometric Mean
2674689|NCT01453387|Secondary|Apparent Oral Clearance of the Drug From Plasma (CL/f)|Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/f was influenced by the fraction absorbed.|Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1.|"Pharmacokinetic analysis set included all the subjects who have received at least one dose of MSC2015103B and who have provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. N signifies the total number of subjects evaluable for this outcome measure."|||Liter/hour||Full Range|Geometric Mean
2674690|NCT01453387|Secondary|AUC Versus Time Curve Within One Dosing Interval (AUC0-tau)||Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. n signifies the number of subjects evaluable for the particular timepoint."|||hours*picogram/milliliter||Full Range|Geometric Mean
2674691|NCT01453387|Secondary|Area Under the Plasma Concentration Curve From Time Zero to Infinity (AUC[0-inf])|The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.|Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.|"Pharmacokinetic analysis set included all the subjects who have received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. n signifies the number of subjects evaluable for the particular timepoint."|||Hour*picogram/milliliter||Full Range|Geometric Mean
2674692|NCT01453387|Secondary|Apparent Terminal Half Life (T1/2)|The apparent terminal half-life was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination.|Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose.n signifies the number of subjects evaluable for the particular timepoint."|||Hour||Full Range|Geometric Mean
2674693|NCT01453387|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)||Schedule 1: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Day 1 and 17.|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. n signifies the number of subjects evaluable for the particular timepoint."|||Hour||Full Range|Geometric Mean
2674694|NCT01453387|Secondary|Maximum Plasma Concentration (Cmax)||Schedule 1 : 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, 24.0, 48 or 72, 72 or 96 and 168 hours post-dose during Week 1 and Week 3; Schedule 2: 0, 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, 8.0, 10.0, and 24.0 hours post-dose on Days 1 and 17.|"Pharmacokinetic analysis set included all the subjects who received at least 1 dose of MSC2015103B and provided sufficient plasma concentrations of MSC2015103B measurement after the first dose. n signifies the number of subjects evaluable for the particular timepoint."|||Picogram per milliliter||Full Range|Geometric Mean
2674980|NCT01451411|Secondary|Number of Patients With Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium||baseline and 48 hours||||participants|||Number
2674695|NCT01453387|Secondary|Number of Subjects Who Experienced Clinically Significant Lab Abnormality Judged to be Related to the Trial Medication|Abnormal laboratory findings and other abnormal investigational findings which were associated with clinical signs and symptoms, lead to treatment discontinuation, or considered medically important by the investigator were reported as AEs.|From the initiation of the trial till the data cut-off date 15 July 2013|The safety analysis set included all the subjects who received at least one administration of the trial medication.|||Subjects|||Number
2674696|NCT01453387|Secondary|Percentage of Subjects Who Experienced Clinically Significant Lab Abnormality Judged to be Related to the Trial Medication|Abnormal laboratory findings and other abnormal investigational findings which were associated with clinical signs and symptoms, lead to treatment discontinuation, or considered medically important by the investigator were reported as AEs.|From the initiation of the trial till the data cut-off date 15 July 2013|The safety analysis set included all the subjects who received at least one administration of the trial medication.|||Percentage of subjects|||Number
2674697|NCT01453387|Secondary|Percentage of Subjects Who Experienced Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. SAE (Serious adverse event) is defined as any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.. TEAEs are events between first dose of study drug up to the cut-off date (15 July 2013) and were absent before treatment or that worsened relative to pretreatment state.|From the initiation of the trial till the data cut-off date 15 July 2013|The safety analysis set included all the subjects who received at least one administration of the trial medication.|||Percentage of subjects|||Number
2674698|NCT01453387|Primary|Percentage of Subjects Who Experienced DLT|DLT was evaluated using the National cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. DLT was defined as any of the following AEs occurring during Cycle 1 that are not related to PD at any dose level: Any Grade 3 or more non-hematological toxicity excluding: Grade 3 diarrhea or associated electrolyte abnormalities that were controlled with adequate and optimal therapies, Grade 3 liver function abnormalities which resolved within 7 days, vomiting. Grade 4 neutropenia of greater than (>) 5 days duration or Grade 3 febrile neutropenia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding, any severe or life threatening AE or any AE or abnormality which impairs daily normal physiological functions, any treatment delay for 2 weeks or more due to adverse effects not related to PD. All events judged to be related by the Investigator to PD were excluded from the DLT definition.|Up to Day 21 of Cycle 1|Safety analysis set included all subjects who received at least one administration of the trial medication.|||Percentage of subjects|||Number
2674699|NCT01453387|Primary|Number of Subjects Who Experienced Dose-limiting Toxicities (DLT)|DLT was evaluated using the National cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. DLT was defined as any of the following AEs occurring during Cycle 1 that are not related to progressive disease (PD) at any dose level: Any Grade 3 or more non-hematological toxicity excluding: Grade 3 diarrhea or associated electrolyte abnormalities that were controlled with adequate and optimal therapies, Grade 3 liver function abnormalities which resolved within 7 days, vomiting. Grade 4 neutropenia of greater than (>) 5 days duration or Grade 3 febrile neutropenia, Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding, any severe or life threatening AE or any AE or abnormality which impairs daily normal physiological functions, any treatment delay for 2 weeks or more due to adverse effects not related to PD. All events judged to be related by the Investigator to PD were excluded from the DLT definition.|Up to Day 21 of Cycle 1|Safety analysis set included all the subjects who received at least one administration of the trial medication.|||Subjects|||Number
2674700|NCT01453374|Secondary|Criminal Activity|Number of subjects who conducted any criminal activity during the study; assessed by review of criminal justice records and completion of the ASI and supplemental questionnaires|6 months|All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data|||participants with criminal activity|||Number
2674701|NCT01453374|Secondary|Cocaine Use|Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests|6 months|All subjects with non-missing data who received at least 1 injection of VIVITROL|||participants who used cocaine|||Number
2674702|NCT01453374|Secondary|Opioid Dependence|Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence|7 months|||||||
2674703|NCT01453374|Secondary|Opioid Craving|Change from baseline in peak craving score 30 days post last injection; assessed using a 100 mm visual analog scale (VAS). Subjects are asked to make 1 slash mark through a point on a 100 mm line that best describes their greatest craving for opioids, whereby 0 represents no craving and 100 is more than ever.|8 months|All subjects with non-missing data who received at least 1 injection of VIVITROL|||units on a scale||Standard Deviation|Mean
2674704|NCT01453374|Secondary|Retention in the Community|Number of subjects who received all 6 post-release VIVITROL injections|6 months|All subjects who received at least 1 injection of VIVITROL|||participants received all 7 injections|||Number
2674705|NCT01453374|Secondary|Drug Abuse Treatment Program Entry|Number of subjects who participated in a drug treatment program during the study; assessed by review of Treatment Services Form.|7 months|All subjects with non-missing data who received at least 1 injection of VIVITROL; 1 subject did not have any outcome data|||participants who entered drug treatment|||Number
2674706|NCT01453374|Secondary|Opioid Overdose|"Number of subjects who overdosed during the study; measured through reported AEs of overdose and Opiate Overdose Form. The Form asks subjects if subjects overdosed during the past 30 days and, if so, how many times."|7 months|All subjects who received at least 1 injection of VIVITROL|||participants who overdosed|||Number
2674707|NCT01453374|Secondary|Opioid Use|Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test.|7 months|All subjects with non-missing data who had at least 1 injection of VIVITROL; 1 subject did not have any outcome data|||participants with positive opioid use|||Number
2674710|NCT01453361|Secondary|Number of Alive Subjects|The survival status in patients with stages IIIc and IV melanoma treated with Vigil™ vaccine was determined by following these patients up to 3 years.|3 years|18 subjects were consented but only 8 were administered Vigil treatment (10 screen-failed). These 8 subjects were followed for survival up to 3 years after Vigil treatment.|||Participants|||Count of Participants
2674711|NCT01453361|Primary|Enzyme-Linked ImmunoSorbent Spot (ELISPOT)|To determine if subjects will have a positive (defined as >10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until EOT (30 days after last dose).|Baseline, End of Treatment (30 days after last dose) up to 12 months|18 subjects were consented but only 8 subjects were administered Vigil treatment (10 screen-failed). 7 completed treatment (ELISPOT done) while 1 subject died soon after baseline (ELISPOT not done). After 12 months, 7 subjects had positive ELISPOT response. Statistical analysis was not done. This study was terminated.|||Participants|||Count of Participants
2674712|NCT01453348|Secondary|Percentages of Subjects With Unsolicited Adverse Events (AEs)|Safety was assessed in terms of percentage of all spontaneously reported AEs collected from the time the subject signed the informed consent form (day 1), until the subject stopped study participation (day 57).|Day 1 to day 57.|Analysis was done on safety set- subjects who provided any post-baseline safety data.|||percentage of subjects|||Number
2674713|NCT01453348|Secondary|hSBA GMTs Assay Titers Against N Meningitidis A, C, W and Y Serogroups at Day 29|Immunogenicity was assessed in terms of geometric mean titers (GMTs) of antibodies to meningococcal serogroups A, C, W and Y on day 29 when given concomitantly with combined hepatitis A/B vaccine or given alone.|28 days post vaccination (day 29).|Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit.|||Titers||95% Confidence Interval|Geometric Mean
2674714|NCT01453348|Secondary|Percentages of Subjects With Seroresponse Against N Meningitidis A, C, W and Y Serogroups at Day 29|"Immunogenicity was assessed as the seroresponse rates for meningococcal serogroups A, C, W and Y elicited by MenACWY-CRM on day 29 when given concomitantly with combined hepatitis A/B vaccine or given alone.~For a subject with a baseline hSBA titer < 1:4, seroresponse is defined as a postvaccination hSBA titer ≥1:8; for a subject with a baseline hSBA titer ≥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline."|28 days postvaccination (day 29).|Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit.|||percentage of subjects||95% Confidence Interval|Number
2674715|NCT01453348|Secondary|Percentages of Subjects With antiHAV and antiHBsAg Antibodies Concentrations Above Seroprotection Level 28 Days After Primary or Booster Vaccination|Immunogenicity was assessed as the percentages of subjects with anti-HAV concentration ≥20 mIU/mL and anti- HBsAg antibody concentration ≥10 mIU/mL, 28 days after primary or booster vaccination.|28 days post primary or booster vaccination.|Analysis was done on modified intention-to-treat (MITT) population- subjects who provided evaluable serum samples whose assay results are available for at least one antigen on visit day 1 and a post baseline visit.|||percentage of subjects||95% Confidence Interval|Number
2674716|NCT01453348|Primary|Geometric Mean antiHAV and antiHBV Concentrations (GMCs), 28 Days After Primary and Booster Vaccination|Assessment was made to demonstrate the non-inferiority of hepatitis A/B vaccine with MenACWY-CRM as compared to hepatitis A/B vaccine without MenACWY-CRM, as measured by geometric mean concentrations on day 57 in previously unvaccinated subjects or on day 29 after a booster dose in previously vaccinated subjects.|Day 57 (previously unprimed subjects) day 29 (previously primed subjects) postvaccination.|Analysis was done on Per Protocol (PP) population who provided evaluable serum samples and whose assay results were available at the relevant time points, and had no major protocol deviations|||Concentrations (mIU/mL)||95% Confidence Interval|Geometric Mean
2674717|NCT01453296|Primary|Weighted Mean QTcF at Day 1 and Day 14 of the Respective Treatment Period|The electrocardiographic (ECG) parameter QT duration corrected using Fridericia's formula (QTcF) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative times were used for these observations. For 0-8 hr parameters, treatment, period, participant Baseline, and period Baseline were fitted as fixed effects, and participant was fitted as a random effect. For 0-2 hr parameters, treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||milliseconds||Standard Error|Least Squares Mean
2674718|NCT01453296|Secondary|Ex-throat Dose (ETD) and ETD <2 Microns on Day 1 and Day 14 of the Respective Treatment Period|"The ex-throat dose (ETD) and the nominal ETD is the mass (micrograms) of active investigational material that passes beyond the throat, nominal being the mean.The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted ETD and ETD <2 microns."|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed.|||micrograms||Standard Deviation|Mean
2674740|NCT01453296|Primary|Mean Corpuscle Hemoglobin (MCH) Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCH at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||10^12 picograms (pg) per cell||Standard Deviation|Mean
2674719|NCT01453296|Secondary|Total Emitted Dose (TED) on Day 1 and Day 14 of the Respective Treatment Period|The total emitted dose (TED) is defined as the mass (micrograms) of the nominal dose that passes beyond the throat. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted total emitted dose.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|||micrograms||Standard Deviation|Mean
2674720|NCT01453296|Secondary|Peak Pressure Drop on Day 1 and Day 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Peak pressure drop is defined as the maximum pressure drop (kilopascal [kPa]) achieved during inhalation across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was calculated for each day (Days 1 and 14 of the respective treatment period), and used for subsequent modeling and prediction of dose emission attributes. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Kilopascal (kpa)||Standard Deviation|Mean
2674721|NCT01453296|Secondary|Inhaled Volume on Day 1 and Day 14 of the Respective Treatment Period|"During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhaled volume is defined as the volume of air (Liters) inhaled during the inhalation across the resistance of the inhaler.~The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalaled volume was determined. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg."|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters||Standard Deviation|Mean
2674722|NCT01453296|Secondary|Inhalation Time on Day 1 and Day 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhalation time is defined as the duration of the inhalation(s) when inhaling across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalation time was determined. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Seconds (sec)||Standard Deviation|Mean
2674723|NCT01453296|Secondary|Average Flow Rate and Peak Inspiratory Flow Rate (PIFR) on Day 1 and Day 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Average flow rate is defined as the average inspiratory flow rate (Liters [L]/min) across the inhalation profile when inhaling across the resistance of the inhaler. PIFR is defined as the Peak Inspiratory Flow Rate (L/min) of the inhalation profile when inhaling across the resistance of the inhaler.The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the average flow rate and PIFR were determined. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters per minute (L/min)||Standard Deviation|Mean
2674724|NCT01453296|Secondary|Oropharyngeal Volume on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Oropharyngeal volume is defined as the volume (centimeters cubed [cm^3]) of the mouth and throat estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||cm^3||Standard Deviation|Mean
2674725|NCT01453296|Secondary|Distance of Assessment on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Distance of assessment is defined as the distance (length measured in centimeters [cm]) estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||centimeters (cm)||Standard Deviation|Mean
2674726|NCT01453296|Secondary|Average Oropharyngeal Cross-sectional Area on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for the study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Pharyngometry data were recorded for each day (Day 1 and Day 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time point were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||centimeters squared (cm^2)||Standard Deviation|Mean
2674727|NCT01453296|Secondary|Blood Glucose and Potassium on Day 14 of the Respective Treatment Period|Blood glucose and potassium values were measured on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period. . Weighted means were derived using the linear trapezoidal rule. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative times were used for these observations. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg. Treatment and period were fitted as fixed effects and participant was fitted as a random effect.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2674728|NCT01453296|Secondary|Tmax, t1/2, and t at Day 14 of the Respective Treatment Period|tmax is defined as the time to reach the observed maximum concentration, t1/2 is defined as the time required to reduce the plasma concentration to one half its initial value, and t is defined as the time of the last observed quantifiable concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 49)|PK Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.|||hours||Full Range|Median
2674729|NCT01453296|Secondary|Cmax on Day 14 of the Respective Treatment Period|Cmax is defined as the maximum observed concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 49)|PK Population|||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
2674730|NCT01453296|Secondary|AUC(0-t) and AUC(0-8) on Day 14 of the Respective Treatment Period|Area under the concentration-time (AUC) curve from time zero (pre-dose) to the last time AUC(0-t) and from time zero to 8 hours AUC(0-8) of quantifiable concentration of VI on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, 4, 6, and 8 hours post-dose for participants who were >=20 kilograms and pre-dose; 10 min and 30 min post-dose; and 1, 2, and 4 hours post-dose for participants who were <=20 kilograms on Day 14 of the respective treatment period. Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Population.|Day 14 of the respective treatment period (up to Study Day 49)|Pharmacokinetic (PK) Population: all participants in the All Subjects Population for whom a PK sample was obtained and analyzee. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
2674739|NCT01453296|Primary|Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||International units per liter (IU/L)||Standard Deviation|Mean
2674731|NCT01453296|Primary|Maximum QTcF at Day 1 and Day 14 of the Respective Treatment Period|The electrocardiographic (ECG) parameter QT duration corrected using Fridericia's formula (QTcF) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. For 0-8 hr parameters, treatment, period, participant Baseline, and period Baseline were fitted as fixed effects, and participant was fitted as a random effect. For 0-2 hr parameters, treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||milliseconds||Standard Error|Least Squares Mean
2674732|NCT01453296|Primary|Weighted Mean Heart Rate at Day 1 and Day 14 of the Respective Treatment Period|Heart rate (HR) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Weighted means were derived using the linear trapezoidal rule. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative times were used for these observations. For 0-8 hr parameters, treatment, period, participant Baseline, and period Baseline were fitted as fixed effects, and participant was fitted as a random effect. For 0-2 hr parameters, treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Beats per minute||Standard Error|Least Squares Mean
2674733|NCT01453296|Primary|Maximum Heart Rate at Day 1 and Day 14 of the Respective Treatment Period|Heart rate (HR) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1 and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Beats per minute||Standard Error|Least Squares Mean
2674734|NCT01453296|Primary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1, Day 8, and Day 14 of the Respective Treatment Period|SBP and DBP were measured at Day 1, Day 8, and Day 14 of the respective treatment period. PD=post-dose. Baseline is defined as the pre-dose measurement at Day 1 for the respective period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1, Day 8, and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2674735|NCT01453296|Primary|Peak Expiratory Flow on Day 1, Day 8, and Day 14 of the Respective Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF is calculated as the maximum of three readings taken at each timepoint for each participant. Baseline is defined as the pre-dose measurement at Day 1 for the respective period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg (n=28).|Day 1, Day 8, and Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||liters/minute||Standard Deviation|Mean
2674736|NCT01453296|Primary|Total Bilirubin, Direct Bilirubin, Creatinine, and Uric Acid Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of total bilirubin, direct bilirubin, creatinine, and uric acid at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2674737|NCT01453296|Primary|Calcium, Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of calcium, chloride, carbon dioxide content/bicarbonate (CO2/BI), glucose, potassium, sodium, and urea/BUN at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2674738|NCT01453296|Primary|Albumin and Total Protein Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of albumin and total protein at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter||Standard Deviation|Mean
2674741|NCT01453296|Primary|Mean Corpuscle Volume (MCV) Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCV at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||10^15 femtoliters (fL) per cell||Standard Deviation|Mean
2674742|NCT01453296|Primary|Hematocrit Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hematocrit at Day 14 of the respective treatment period. Hematocrit is a measure of the percentage of the volume of the whole blood that is composed of red blood cells, as determined by separation of red blood cells from the plasma (usually by centrifugation). Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||proportion of 1||Standard Deviation|Mean
2674743|NCT01453296|Primary|Reticulocyte and Red Blood Cell (RBC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of reticulocytes and RBCs at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
2674744|NCT01453296|Primary|Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hemoglobin and MCHC at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter (g/L)||Standard Deviation|Mean
2674745|NCT01453296|Primary|Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil, Platelet, and White Blood Cell Count Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelets, and white blood cell (WBC) count at Day 14 of the respective treatment period. Subject 2308 received VI 25 µg in both treatment periods, and contributed twice to the summary of VI 25 µg.|Day 14 of the respective treatment period (up to Study Day 49)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
2674746|NCT01453296|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Week 11 (Visit 8)/Early Withdrawal|All Subjects Population: all participants who received at least one dose of study medication|||Participants|||Number
2674747|NCT01453205|Secondary|Half-life (T1/2) of MEDI-551|Terminal elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.|Cycle 1 and EOT (Day 21 of Cycle 3 [each cycle of 21 days] or earlier cycles if treatment stopped before Cycle 3)|Participants who received MEDI-551 were analyzed for this end point.|||Day||Standard Deviation|Mean
2674748|NCT01453205|Secondary|Mean Serum Concentration of MEDI-551|The mean serum concentration of MEDI-551 were observed.|Cycle 1 Day -7 Post dose, pre-dose and postdose on Day 1, post-dose on Days 4, 8, 15 of Cycle 1, pre-dose and postdose on Day 1 of Cycle 2 and Cycle 3|Participants who received MEDI-551 were analyzed for this end point.|||mcg/mL||Standard Deviation|Mean
2674749|NCT01453205|Secondary|Number of Participants Who Developed Detectable MEDI-551 Anti-drug Antibodies (ADA)|A participant was considered ADA-positive across the study if they had a positive reading (titer of 50 or higher) at any time point during the study.|7 days before the start of Cycle 1, Day 1 of each subsequent Cycle, EOT, and post EOT on Days 30, 60, 90 and 270 (up to 36 months from the randomization of last participant)|Safety population included all participants who received any study treatment.|||Participants|||Count of Participants
2674750|NCT01453205|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs and ECG Abnormalities|Vital signs included parameters such as heart rate, blood pressure, temperature, and respiratory rate. An abnormal vital signs and ECG findings that was judged by the investigator to be clinically significant was reported an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-551, or events absent at baseline that emerged after administration of MEDI-551, for the period extending to 90 days after the end of study treatment.|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|Safety population included all participants who received any study treatment.|||Participants|||Count of Participants
2674759|NCT01453205|Secondary|Overall Survival (OS)|Overall survival is defined as the time from randomization until death due to any cause according to the International Working Group criteria. OS (months) = (Date of death or censoring - Date of randomization + 1) / (365.25/12).|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|Intent-To-Treat population included all participants who were randomized into the study.|||months||95% Confidence Interval|Median
2674751|NCT01453205|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Chemistry Laboratory Results (Include Urinalysis)|An abnormal laboratory findings that was judged by the investigator to be clinically significant was reported as an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-551, or events absent at baseline that emerged after administration of MEDI-551, for the period extending to 90 days after the end of study treatment.|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|Safety population included all participants who received any study treatment.|||Participants|||Count of Participants
2674752|NCT01453205|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Hematology/Coagulation Laboratory Results|An abnormal laboratory finding that was judged by the investigator to be clinically significant was reported as an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of MEDI-551, or events absent at baseline that emerged after administration of MEDI-551, for the period extending to 90 days after the end of study treatment (EOT).|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|Safety population included all participants who received any study treatment.|||Participants|||Count of Participants
2674753|NCT01453205|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)|An Adverse Event (AE) is any unfavourable and unintended signs, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. Serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, life-threatening, a congenital anomaly/birth defect, or an important medical event. TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 90 days after the end of treatment (EOT).|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|Safety population included all participants who received any study treatment.|||Participants|||Count of Participants
2674754|NCT01453205|Secondary|Acceptable Dose of MEDI-551|Acceptable dose for MEDI-551 was evaluated based on the benefit-risk analysis.|After the administration of the first dose of MEDI-551 (7 days before the Cycle 1) to last dose of MEDI-551 (Cycle 3 Day 1) (each cycle of 21 days)|All participants who were randomized into the study and received MEDI-551.|||milligram per kilogram (mg/kg)|||Number
2674755|NCT01453205|Secondary|Number of Participants With Best Overall Response Assessed by Blinded Independent Central Review (BICR)|The best overall response was calculated, based upon the disease assessments recorded during the study visits, and summarized with the number of participants for the following categories: CR, PR, stable disease (SD), PD, and unknown. Responses were assessed according to the International Working Group criteria. CR: disappearance of all evidence of disease; PR: 50% decrease in the SPD of up to 6 largest dominant nodal masses and >= 50% decrease in SPD of spleen/liver nodules; PD: appearance of any new lesions or >= 50% increase in SPD of more than one node or >= 50% increase in longest diameter of a previously identified node or >50% increase from nadir in the SPD of any previous lesions; SD: failure to attain CR/PR or PD.|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|ITT population included all participants who were randomized into the study.|||Participants|||Count of Participants
2674756|NCT01453205|Secondary|Duration of Response (DR)|Duration of Response (DR) is defined as time from start of first documented objective response (confirmed CR or confirmed PR) to first documented PD according to the International Working Group criteria. CR is defined as disappearance of all evidence of disease. PR is defined as 50% decrease in the SPD of up to 6 largest dominant nodal masses and >= 50% decrease in SPD of spleen/liver nodules. PD: appearance of any new lesions or >= 50% increase in SPD of more than one node or >= 50% increase in longest diameter of a previously identified node or > 50% increase from nadir in the SPD of any previous lesions. Only participants who have achieved objective response assessed by investigator were evaluated. DR calculated as (months) = (Date of PD or censoring - Date of first disease response + 1)/ (365.25/12).|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|"Intent-To-Treat population included all participants who were randomized into the study. Here, N is number of participants analyzed for this outcome measure."|||months||95% Confidence Interval|Median
2674757|NCT01453205|Secondary|Time to Response (TTR)|Time to response (TTR) is defined as the time from randomization until the first documentation of disease response according to the International Working Group criteria. Only participants who have achieved objective response (confirmed CR or confirmed PR) assessed by investigator were evaluated for TTR. CR is defined as disappearance of all evidence of disease. PR is defined as 50% decrease in the SPD of up to 6 largest dominant nodal masses and >= 50% decrease in SPD of spleen/liver nodules. TTR (months) = (Date of first disease response - Date of randomization + 1) / (365.25/12).|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|"ITT population included all participants who were randomized into the study. Here, N is number of participants analyzed for this outcome measure."|||months||Full Range|Median
2674758|NCT01453205|Secondary|Time to Progression (TTP)|Time to Progression (TTP) is defined as the time from randomization until the first documentation of PD according to the International Working Group criteria. PD is defined as appearance of any new lesions or >= 50% increase in SPD of more than one node or >= 50% increase in longest diameter of a previously identified node or >50% increase from nadir in the SPD of any previous lesions. TTP (months) = (Date of PD or censoring - Date of randomization + 1) / (365.25/12).|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|Intent-To-Treat population included all participants who were randomized into the study.|||months||Full Range|Median
2674869|NCT01452529|Primary|"Mean Pain Intensity for Average Pain Over the Last 24 Hours Score"|"Mean pain intensity for average pain over the last 24 hours score (on an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine)."|Week 12|The full analysis population (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||units on a scale||Standard Error|Mean
2674760|NCT01453205|Secondary|Event-Free Survival (EFS)|Event-Free Survival (EFS) is defined as the time from randomization until the first documentation of EFS events which include PD, initiation of alternative antitumor treatment or death due to any cause, whichever occurs first according to the International Working Group criteria. PD is defined as appearance of any new lesions or >= 50% increase in SPD of more than one node or >= 50% increase in longest diameter of a previously identified node or >50% increase from nadir in the SPD of any previous lesions. EFS (months) = (Date of EFS or censoring - Date of randomization + 1) / (365.25/12).|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|Intent-To-Treat population included all participants who were randomized into the study.|||months||Full Range|Median
2674761|NCT01453205|Secondary|Progression-Free Survival (PFS)|Progression-free survival (PFS) is defined as the time from randomization until the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first according to the International Working Group criteria. PD is defined as appearance of any new lesions or >= 50% increase in SPD of more than one node or >= 50% increase in longest diameter of a previously identified node or >50% increase from nadir in the SPD of any previous lesions. PFS (months) = (Date of PD/death or censoring - Date of randomization + 1) / (365.25/12).|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|Intent-To-Treat population included all participants who were randomized into the study.|||months||Full Range|Median
2674762|NCT01453205|Primary|Objective Response Rate (ORR)|Objective Response Rate is defined as the proportion of participants with a best response of complete response (CR) or partial response (PR) according to the International Working Group criteria. CR is defined as disappearance of all evidence of disease. PR is defined as 50 percent (%) decrease in the sum of the product of the perpendicular diameters (SPD) of up to 6 largest dominant nodal masses and greater than or equal to (>=) 50% decrease in SPD of spleen/liver nodules.|From treatment administration (Day 1) to 90 days after the end of study treatment (up to approximately 36 months from the randomization of last participant)|Intent-To-Treat population included all participants who were randomized into the study.|||Percentage of participants||95% Confidence Interval|Number
2674763|NCT01453166|Secondary|Blood Glucose|Change From Baseline in blood glucose|12 weeks|Participants who were evaluable at this time point were analyzed|||mg/dl||Standard Error|Mean
2674764|NCT01453166|Secondary|Waist Circumference|Change From Baseline in wais circumference|12 weeks|Participants who were evaluable at this time point were analyzed|||cm||Standard Error|Mean
2674765|NCT01453166|Primary|Total Cholesterol|Change From Baseline in total Cholesterol|12 weeks|Participants who were evaluable at this time point were analyzed.|||mg/dl||Standard Error|Mean
2674766|NCT01453166|Secondary|Weight|Change From Baseline in weight|12 weeks|Participants who were evaluable at this time point were analyzed|||kg||Standard Error|Mean
2674767|NCT01453166|Primary|Systolic Blood Pressure|Change From Baseline in systolic blood pressure|12 weeks|Participants who were evaluable at this time point were analyzed|||mmHg||Standard Error|Mean
2674768|NCT01453153|Secondary|Change From Baseline in CA19-9 in Participants Classified as Responders and Non-responders|CA19-9 is a tumor marker. Blood samples (plasma) were collected for CA19-9 evaluations. Responders are defined as participants who had a complete response or partial response, and non-responders are defined as participants who had stable disease, progressive disease, or an unknown tumor response, per RECIST, Version 1.1.|up to the end of Cycle 10 (up to Week 44)|Intent-to-Treat Population. Only those participants with available data were analyzed. This study was to consist of a Phase 1b and a randomized Phase 2 study. However, the randomized Phase 2 study was not conducted due to a change to the standard-of-care chemotherapy treatment to be used in combination with PEGPH20.|||U/ml||Standard Deviation|Mean
2674769|NCT01453153|Secondary|Change From Baseline in CA19-9 in Participants With a Baseline Value >=59 U/ml|CA19-9 is a tumor marker. Blood samples (plasma) were collected for CA19-9 evaluations.|up to the end of Cycle 10 (up to Week 44)|Intent-to-Treat Population. Only those participants with available data were analyzed. This study was to consist of a Phase 1b and a randomized Phase 2 study. However, the randomized Phase 2 study was not conducted due to a change to the standard-of-care chemotherapy treatment to be used in combination with PEGPH20.|||U/ml||Standard Deviation|Mean
2674770|NCT01453153|Secondary|Change From Baseline in Carbohydrate Antigen 19-9 or Sialylated Lewis(a) Antigen (CA19-9)|CA19-9 is a tumor marker. Blood samples (plasma) were collected for CA19-9 evaluations.|up to the end of Cycle 10 (up to Week 44)|Intent-to-Treat Population. Only those participants with available data were analyzed. This study was to consist of a Phase 1b and a randomized Phase 2 study. However, the randomized Phase 2 study was not conducted due to a change to the standard-of-care chemotherapy treatment to be used in combination with PEGPH20.|||Units per milliliter (U/ml)||Standard Deviation|Mean
2674771|NCT01453153|Secondary|Overall Survival|Overall survival was defined as the time from the time of the first dose of PEGPH20 until death.|from the time of the first dose of PEGPH20 until death (up to approximately 2 years 4 months)|Intent-to-Treat Population. This study was to consist of a Phase 1b and a randomized Phase 2 study. However, the randomized Phase 2 study was not conducted due to a change to the standard-of-care chemotherapy treatment to be used in combination with PEGPH20.|||days||95% Confidence Interval|Median
2674772|NCT01453153|Secondary|Progression-free Survival (PFS)|PFS duration was defined as the time from the first dose of PEGPH20 until objective tumor progression or death. Per RECIST, Version 1.1, for the evaluation of target lesions, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters. Note: the appearance of 1 or more new lesions is also considered progression. For the evaluation of nontarget lesions, progressive disease is defined as the unequivocal progression of existing nontarget lesions. Note: The appearance of 1 or more new lesions is also considered progression.|from the first dose of PEGH20 until objective tumor progression or death (up to approximately 2 years 4 months)|Intent-to-Treat Population. This study was to consist of a Phase 1b and a randomized Phase 2 study. However, the randomized Phase 2 study was not conducted due to a change to the standard-of-care chemotherapy treatment to be used in combination with PEGPH20.|||days||95% Confidence Interval|Median
2674773|NCT01453153|Secondary|Disease Control Rate|Disease Control Rate is defined as the sum of the number of participants with a complete response, the number of participants with a partial response, and the number of participants with stable disease per RECIST, Version 1.1. For TLs, CR: Disappearance of all TLs. PR: >=30% decrease in the sum of diameters of TLs, referencing baseline sums. SD: Neither sufficient shrinkage to qualify for PR nor sufficient to qualify for PD, referencing the smallest sum diameters. For NTLs, CR: Disappearance of all NTLs and normalization of tumor marker level. All lymph nodes must be nonpathological in size (short axis <10 mm). Incomplete response/SD: Persistence of >=1 NTLs and/or maintenance of tumor marker level above normal limits.|up to approximately 2 years 4 months|Intent-to-Treat Population. This study was to consist of a Phase 1b and a randomized Phase 2 study. However, the randomized Phase 2 study was not conducted due to a change to the standard-of-care chemotherapy treatment to be used in combination with PEGPH20.|||Participants|||Count of Participants
2674774|NCT01453153|Secondary|Objective Response Rate|Objective Response Rate is defined as the number of participants with a complete response plus the number of participants with a partial response, per RECIST, Version 1.1. For TLs, CR: Disappearance of all TLs. PR: >=30% decrease in the sum of diameters of TLs, referencing baseline sums. For NTLs, CR: Disappearance of all NTLs and normalization of tumor marker level. All lymph nodes must be nonpathological in size (short axis <10 mm). Incomplete response/SD: Persistence of >=1 NTLs and/or maintenance of tumor marker level above normal limits.|up to approximately 2 years 4 months|Intent-to-Treat Population. This study was to consist of a Phase 1b and a randomized Phase 2 study. However, the randomized Phase 2 study was not conducted due to a change to the standard-of-care chemotherapy treatment to be used in combination with PEGPH20.|||Participants|||Count of Participants
2674775|NCT01453153|Secondary|Number of Participants With the Indicated Best Response, Per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1|Target lesions (TLs), complete response (CR): Disappearance of all TLs. Partial response (PR): >=30% decrease in the sum of diameters of TLs, referencing baseline sums. Progressive disease (PD): >= 20% increase in the sum of diameters of TLs, referencing the smallest sum (including baseline sum). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of >=5 mm. (The appearance of >=1 new lesions is considered progression.) Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient to qualify for PD, referencing the smallest sum diameters. For nontarget lesions (NTLs), CR: Disappearance of all NTLs and normalization of tumor marker level. All lymph nodes must be nonpathological in size (short axis <10 mm). Incomplete response/SD: Persistence of >=1 NTLs and/or maintenance of tumor marker level above normal limits. PD: Unequivocal progression of existing NTLs. (The appearance of >=1 new lesions is considered progression.)|up to approximately 2 years 4 months|Intent-to-Treat Population. This study was to consist of a Phase 1b and a randomized Phase 2 study. However, the randomized Phase 2 study was not conducted due to a change to the standard-of-care chemotherapy treatment to be used in combination with PEGPH20.|||Participants|||Count of Participants
2674776|NCT01453153|Secondary|Mean Extravascular-Extracellular Volume Fraction (Ve) for Scans Across Tissue Sites|DCE-MRI provides a measure of the exchange of small-molecule contrast agents between the intracellular and extracellular spaces. Ve is defined as the extravascular-extracellular volume fraction and is a measure of extracellular, extravascular space. Mean Ve values across scan sites are reported per participant. DCE-MRI was performed before the first dosing visit (Week 1/Day 1), 24 hours after the first dose of PEGPH20 in Cycle 1, and 24 hours after the last dose of PEGPH20 in Cycle 1 (Week 7). Assessment was done for the entire cohort of participants, not per treatment group.|Baseline; 24 hours hours; end of Cycle 1 (Week 7)|ITT Population. DCE-MRI scans were performed for 6 participants. Only participants with data available were analyzed. This study was to consist of a Phase 1b and a randomized Phase 2 study. However, the randomized Phase 2 study was not conducted due to a change to the standard-of-care chemotherapy treatment to be used in combination with PEGPH20.|||milliliters||Standard Deviation|Mean
2674777|NCT01453153|Secondary|Mean Volume Transfer Constant (Ktrans) for Scans Across Tissue Sites|Dynamic control enhanced-magnetic resonance imaging (DCE-MRI) provides a measure of the exchange of small-molecule contrast agents between the intracellular and extracellular spaces. Using a 2-compartment pharmacokinetic model, an estimate of tissue (tumor) perfusion can be obtained by determining the exchange rate constant (Ktrans) of contrast exchange. Ktrans is defined as the volume transfer constant between extravascular/extracellular space to plasma space and is a measure of blood flow, vascular permeability, or both. Mean Ktrans values across scan sites are reported per participant. DCE-MRI was performed before the first dosing visit (Week 1/Day 1), 24 hours after the first dose of PEGPH20 in Cycle 1, and 24 hours after the last dose of PEGPH20 in Cycle 1 (Week 7). Assessment was done for the entire cohort of participants, not per treatment group.|Baseline; 24 hours hours; end of Cycle 1 (Week 7)|ITT Population. DCE-MRI scans were performed for 6 participants. Only participants with data available were analyzed. This study was to consist of a Phase 1b and a randomized Phase 2 study. However, the randomized Phase 2 study was not conducted due to a change to the standard-of-care chemotherapy treatment to be used in combination with PEGPH20.|||milliliters (mL) per minute per 100 mL||Standard Deviation|Mean
2674778|NCT01453153|Secondary|Percent Change in in the Maximum Standardized Uptake Value (SUVmax), as an Assessment of Total Lesion Metabolic Activity|PEGPH20's effect on the metabolic activities of the tumor was assessed as the percent change in SUVmax (a measure of total lesion metabolic activity) using fluorodeoxyglucose-positron emission tomography/computed tomography (18F-FDG-PET/CT). Assessment was done for the entire cohort of participants, not per treatment group.|Baseline; up to 32 weeks for each individual participant (end of Cycle 7)|Intent-to-Treat Population. Only those participants with available data were analyzed. This study was to consist of a Phase 1b and a randomized Phase 2 study. However, the randomized Phase 2 study was not conducted due to a change to the standard-of-care chemotherapy treatment to be used in combination with PEGPH20.|||percent change||Standard Deviation|Mean
2674788|NCT01453153|Secondary|Last Measurable Observed Plasma Concentration (Cmin) Following Single PEGPH20 Doses|Blood samples were collected for pharmacokinetic assessment.|Cycle 1, Week 1, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)|Intent-to-Treat Population. Only those participants with available data were analyzed.|||units per milliliter||Standard Deviation|Mean
2674870|NCT01452425|Primary|Intracompartmental Pressure (ICP)|[mean (SD)] ICP (in mmHg), value at baseline and at the time of the block|45 minutes||||mmHg||Standard Deviation|Mean
2674779|NCT01453153|Secondary|H-scores, as an Assessment of HA Staining Changes in Tumor Biopsies|An H-score approach methodology was developed and used to analyze staining in the tumor pericellular regions and the stroma separately. The H-score calculation was the sum of the products of the percentage of positive staining areas and the staining intensity (0, 1, 2 or 3), and ranged from 0 to 300. For example: [90% * 1 (weak)] + [10% * 2 (moderate)] + [0% * 3 (strong)] = 110. A score of 0 represents the absence of expression, and an H-score of 300 represents maximum expression. A larger decrease in H-score correlated with a greater target engagement of PEGPH20. As HA is a secreted protein, the scoring was performed in the immediate areas surrounding tumor (pericellular areas) as well as in stroma.|Screening; Cycle 1 Week 7|Intent-to-Treat Population. Only 1 participant had a screening and post-treatment specimen that qualified for staining. This study was to consist of a Phase 1b and a randomized Phase 2 study. However, the randomized Phase 2 study was not conducted due to a change to the standard-of-care chemotherapy treatment to be used in combination with PEGPH20.|||score on a scale|||Number
2674780|NCT01453153|Secondary|Plasma Hyaluronan (HA) Concentration at Baseline and After PEGPH20 Administration|The pharmacodynamic activity of PEGPH20 was evaluated by measuring plasma concentrations of HA after PEGPH20 dosing. Peak HA concentrations are the highest concentrations measured after a single dose of PEGPH20. HA samples were collected in Cycle 1 at the following time points: 1) Week 1/Day 1 (first visit) and Week 4 (first visit): predose and 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing (24-hour sample optional for Week 4); 2) all other visits in Cycle 1: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given). HA samples were collected in Cycles 2+ at the following time points: Week 3 of each cycle pre-PEGPH20 dose and 1 to 2 hours post-PEGPH20 dose.|Baseline; post-Baseline (average treatment duration of 94.6 days)|Intent-to-Treat Population. This study was to consist of a Phase 1b and a randomized Phase 2 study. However, the randomized Phase 2 study was not conducted due to a change to the standard-of-care chemotherapy treatment to be used in combination with PEGPH20.|||nanograms per milliliter||Standard Deviation|Mean
2674781|NCT01453153|Secondary|AUC0-T Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks|Blood samples were collected for pharmacokinetic assessment. The 24-hour sample collected at the first visit was optional. AUC0-T was calculated by the linear trapezoidal rule.|Cycle 1, Week 4, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)|Intent-to-Treat Population. Only those participants with available data were analyzed.|||Units*hour/milliliter||Standard Deviation|Mean
2674782|NCT01453153|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Measurable Plasma Concentration (AUC0-T) Following Single PEGPH20 Doses|Blood samples were collected for pharmacokinetic assessment. AUC0-T was calculated by the linear trapezoidal rule.|Cycle 1, Week 1, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)|Intent-to-Treat Population|||Units*hour/milliliter||Standard Deviation|Mean
2674783|NCT01453153|Secondary|t1/2 Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks|The apparent half-life calculated by ln(2)/λ, where λ was the rate constant for the log-linear portion of the terminal phase. A minimum of 3 values in the postdistribution phase of the plasma concentration-time curve were required for calculation of λ. Blood samples were collected for pharmacokinetic assessment. The 24-hour sample collected at the first visit was optional. t1/2 is expressed as harmonic mean and pseudo standard deviation.|Cycle 1, Week 4, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)|Intent-to-Treat Population. Only those participants with available data were analyzed.|||hours||Standard Deviation|Mean
2674784|NCT01453153|Secondary|Apparent Half-life (t1/2) Following Single PEGPH20 Doses|The apparent half-life calculated by ln(2)/λ, where λ was the rate constant for the log-linear portion of the terminal phase. A minimum of 3 values in the postdistribution phase of the plasma concentration-time curve were required for calculation of λ. Blood samples were collected for pharmacokinetic assessment. t1/2 is expressed as harmonic mean and pseudo standard deviation.|Cycle 1, Week 1, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)|Intent-to-Treat Population. Only those participants with available data were analyzed. t1/2 values were not calculated for the 1.0 μg/kg dose because there were insufficient data points in the profiles due to low concentrations.|||hours||Standard Deviation|Mean
2674785|NCT01453153|Secondary|Tmax Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks|Blood samples were collected for pharmacokinetic assessment. The 24-hour sample collected at the first visit was optional.|Cycle 1, Week 4, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)|Intent-to-Treat Population. Only those participants with available data were analyzed.|||hours||Full Range|Median
2674786|NCT01453153|Secondary|Time to Reach Cmax (Tmax) Following Single PEGPH20 Doses|Blood samples were collected for pharmacokinetic assessment.|Cycle 1, Week 1, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)|Intent-to-Treat Population. Only those participants with available data were analyzed.|||hours||Full Range|Median
2674787|NCT01453153|Secondary|Cmin Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks|Blood samples were collected for pharmacokinetic assessment. The 24-hour sample collected at the first visit was optional.|Cycle 1, Week 4, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)|Intent-to-Treat Population. Only those participants with available data were analyzed.|||Units per milliliter||Standard Deviation|Mean
2674981|NCT01451411|Secondary|Time From the First Dose of Study Medication to a Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium||48 hours|Data from two subjects (one conivaptan, and one placebo) were censored as the serum sodium never achieved a value greater or equal to 4 mEq/L above the baseline value.|||hours||Full Range|Mean
2674789|NCT01453153|Secondary|Cmax Following Twice-weekly PEGPH20 Doses for 3 Consecutive Weeks|Cmax is defined as the observed maximum plasma concentration after the first dose. Blood samples were collected for pharmacokinetic assessment. The 24-hour sample collected at the first visit was optional.|Cycle 1, Week 4, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)|Intent-to-Treat Population: all enrolled participants. Only those participants with available data were analyzed.|||units per milliliter||Standard Deviation|Mean
2674790|NCT01453153|Secondary|Observed Maximum Plasma Concentration (Cmax) Following Single PEGPH20 Doses|Cmax is defined as the observed maximum plasma concentration after the first dose. Blood samples were collected for pharmacokinetic assessment.|Cycle 1, Week 1, Day 1: First visit: predose; 15 minutes, 1, 2, 4, and 24 hours post-PEGPH20 dosing; all other visits: pre-PEGPH20 dose, 1 to 2 hours post-PEGPH20 dose, and immediately after the dose of gemcitabine (on the days gemcitabine was given)|Intent-to-Treat Population: all enrolled participants|||units per milliliter||Standard Deviation|Mean
2674791|NCT01453153|Primary|Recommended Phase 2 Dose (RP2D)|The safety and tolerability profile of PEGPH20 used in combination with gemcitabine was assessed by determining the RP2D, the highest dose level at which no more than 1 of 6 evaluable participants experienced a DLT in the first 4 weeks of treatment (considered a safe dose). The RP2D was determined based on review of safety and pharmacokinetic (PK) data from participants enrolled during the dose-escalation phase of the study.|first 4 weeks of Cycle 1|The DLT Evaluable Population: all participants enrolled during the dose escalation portion of the study who received at least 6 of 8 planned doses of PEGPH20 and 3 of 4 doses of gemcitabine in the first 4 weeks or had a DLT in the first 4 weeks|||micrograms per kilogram (μg/kg)|||Number
2674792|NCT01453153|Primary|Number of Participants With a Dose-limiting Toxicity (DLT)|The safety and tolerability profile of PEGPH20 used in combination with gemcitabine was assessed by measuring the number of participants with a DLT during the dose-escalation phase of the study. A DLT was defined as any treatment-emergent National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE), Version 4.0, Grade 3 or greater event occurring within the first 4 weeks of treatment that was considered related to PEGPH20. Any PEGPH20 treatment-related AE that resulted in a drug interruption or reduction might have been considered a DLT at the Investigator's or Sponsor's discretion. Hypersensitivity/infusion reactions related to PEGPH20 dosing were not considered DLTs.|first 4 weeks of Cycle 1|The DLT Evaluable Population: all participants enrolled during the dose escalation portion of the study who received at least 6 of 8 planned doses of PEGPH20 and 3 of 4 doses of gemcitabine in the first 4 weeks or had a DLT in the first 4 weeks.|||Participants|||Count of Participants
2674793|NCT01453075|Primary|Effect of HSV-2 Suppression on HCV Viral Load.|Measure the change in serum HCV viral load at baseline and 12 weeks in patients who have chronic hepatitis C and HSV-2 infection who receive the 3 grams daily valacyclovir versus placebo|baseline; 12 weeks|Analyzed patients who completed study|||log(IU/mL)||Standard Error|Mean
2674794|NCT01453049|Secondary|Change From Baseline in Electrocardiogram (ECG) Data at Week 24/EW|PR, QT, QTc, RR, QRS, and QRS axis data were measured by ECG. The PR interval (int.) starts at the beginning of the atrial contraction and ends at the beginning of the ventricular contraction. QT (QT int.) and QTc (corrected QT int.) indicate how fast the ventricles are repolarized, becoming ready for a new cycle. The RR int. represents the duration of the ventricular cardiac cycle and is an indicator of ventricular rate. QRS (QRS duration) indicates how fast the ventricles depolarize. The QRS axis is an indicator of the electrical heart axis, which is an average of all heart depolarization.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||milliseconds (msec)||Standard Deviation|Mean
2674795|NCT01453049|Secondary|Change From Baseline in Electrocardiogram (ECG) Assessment of Heart Rate at Week 24/EW|Electrocardiograms of the participants were taken for the evaluation of heart rate. Change from Baseline in heart rate was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||bpm||Standard Deviation|Mean
2674796|NCT01453049|Secondary|Change From Baseline in Weight at Week 24/EW|The weight of the participants was measured. Change from Baseline in weight was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||kilograms (kg)||Standard Deviation|Mean
2674797|NCT01453049|Secondary|Change From Baseline in Heart Rate at Week 24/EW|The heart rate of the participants was measured. Change from Baseline in heart rate was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||beats per minute (bpm)||Standard Deviation|Mean
2674798|NCT01453049|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24/EW|The blood pressure of the participants was measured. Change from Baseline in SBP and DBP was calculated as the value at Weeks 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2674799|NCT01453049|Secondary|Change From Baseline in Total Bilirubin (TB), Direct Bilirubin (DB), Creatinine, and Uric Acid (UC) at Week 24/EW|Blood samples of participants were collected for TB, DB, creatinine, and UC assessment. Change from Baseline in TB, DB, creatinine, and UC was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Micromoles per liter (mcmol/L)||Standard Deviation|Mean
2674800|NCT01453049|Secondary|Change From Baseline in Alanine Transaminase (ALT), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT), Lactate Dehydrogenase (LDH), Alkaline Phosphatase (ALP), and Creatine Kinase (CK) at Week 24/EW|Blood samples of participants were collected for ALT, AST, GGT, LDH, ALP, and CK assessment. Change from Baseline in ALT, AST, GGT, LDH, ALP, and CK was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Units per liter (U/L)||Standard Deviation|Mean
2674982|NCT01451411|Primary|Mean Change From Baseline to the End of the 48-hour Treatment Period in Serum Sodium||baseline and 48 hours||||mEq/L||Standard Deviation|Mean
2674801|NCT01453049|Secondary|Change From Baseline in Mean Corpuscular Hemoglobin (MCH) at Week 24/EW|Blood samples of participants were collected for MCH assessment. Change from Baseline in MCH was calculated as the value at Week 24/EW minus the value at Baseline. MCH is the average amount of hemoblobin inside a RBC expressed in picograms. MCH is calculated by dividing the hemoglobin concentration in grams per deciliter by the RBC count in millions per microliter, then multiplying by 10. MCH is one of the three main RBC indices which are helpful to determine the cause of anemia.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Picograms (pg) per cell||Standard Deviation|Mean
2674802|NCT01453049|Secondary|Change From Baseline in Mean Corpuscular Volume (MCV) at Week 24/EW|Blood samples of participants were collected for MCV assessment. Change from Baseline in MCV was calculated as the value at Week 24/EW minus the value at Baseline. MCV is the average size of the red blood cells expressed in femtoliters. MCV is calculated by dividing the hematocrit (as percent) by the RBC count in millions per microliter of blood, then multiplying by 10. MCV is one of the three main RBC indices that are helpful in determining the cause of anemia.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Femtoliters (FL) per cell||Standard Deviation|Mean
2674803|NCT01453049|Secondary|Change From Baseline in Hemoglobin (HE), Mean Corpuscular Hemoglobin Concentration (MCHC), Total Protein (TP), and Albumin at Week 24/EW|Blood samples of participants were collected for HE, MCHC, and TP assessment. Change from Baseline in HE, MCHC, and TP was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Grams per liter (G/L)||Standard Deviation|Mean
2674804|NCT01453049|Secondary|Change From Baseline in Hematocrit (HCT) at Week 24/EW|Blood samples of participants were collected for HCT assessment. Change from Baseline in HCT was calculated as the value at Week 24/EW minus the value at Baseline. HCT is measured as the percentage of the volume of whole blood that is made up of red blood cells.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||percentage of volume of whole blood||Standard Deviation|Mean
2674805|NCT01453049|Secondary|Change From Baseline in Lymphocytes, Monocytes, Neutrophils, Eosinophils, and Basophils at Week 24/EW|Blood samples of participants were collected for lymphocyte, monocyte, neutrophil, eosinophil, and basophil assessment. Change from Baseline in lymphocytes, monocytes, neutrophils, eosinophils, and basophils was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||percent of WBC count||Standard Deviation|Mean
2674806|NCT01453049|Secondary|Change From Baseline in Red Blood Cell (RBC) Count at Week 24/EW|Blood samples of participants were collected for RBC count assessment. Change from Baseline in RBC count was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Pico per liter (10^12/ L) cells||Standard Deviation|Mean
2674807|NCT01453049|Secondary|Change From Baseline in White Blood Cell (WBC) Count and Platelet Count at Week 24/EW|Blood samples of participants were collected for WBC count and platelet count assessment. Change from Baseline in WBC count and platelet count was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Giga per liter (10^9/L) cells||Standard Deviation|Mean
2674808|NCT01453049|Secondary|Number of Participants With a Bone Fracture|Participants with a break in the continuity (fracture) of the bone were evaluated.|Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
2674809|NCT01453049|Secondary|Number of Hypoglycemic Events|A hypoglycemic event is a condition that occurs when the blood glucose is below 70 mg/dL or 4 mmol/L. All participants, participants with HbA1c <7%, or who achieved a decrease of >= 0.7% from Baseline at Week 24 (HbA1c responders); and participants who had a >=1.7 mmol/L decrease from Baseline FPG or who achieved a FPG <6.1 mmol/L at Week 24 (FPG responders) were evaluated.|Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||Hypoglycemic events|||Number
2674810|NCT01453049|Secondary|Number of Participants With Hypoglycemic Events|Blood samples of participants were collected for the assessment of blood glucose levels. Hypoglycemia is a condition that occurs when the blood glucose is below 70 mg/dL or 4 mmol/L. All participants; participants with HbA1c <7%, or who achieved a decrease of >= 0.7% from Baseline at Week 24 (HbA1c responders); and participants who had a >=1.7 mmol/L decrease from Baseline FPG or who achieved a FPG <6.1 mmol/L at Week 24 (FPG responders) were evaluated.|Week 24/EW|Safety Population. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
2674811|NCT01453049|Secondary|Change From Baseline in Adjusted Diabetes Quality of Life (A-DQOL) Scores at Week 24/EW|In diabetic participants, QOL, anxiety, and depression were measured by the A-DQOL scale . There are 46 core items (10 additional items for adolescents) and 4 major dimensions: treatment satisfaction, treatment impact, worry about long-term complications, and worry about social/vocational issues. Participants respond to all items on a 5-point Likert scale: 1, no impact, no worries, or always satisfied; 5, always affected, always worried, or never satisfied. The total score is a sum of the individual scores of all 46 items (range of 46 to 230); a lower score indicates a better QOL.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.|||scores on a scale||Standard Deviation|Mean
2674812|NCT01453049|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 24/EW|EQ-5D is used as a measure of health outcome and includes single-item measures (coded on a 3-point scale [1, no problems; 2, some problems; 3, severe problems]) of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The instrument includes a global rating of current health using a visual analog scale (VAS): 0 (worst imaginable) to 100 (best imaginable). Health states may be converted to a single summary index by applying a formula that attaches values to each of the levels in each dimension. The index scale is -0.111 to 1. A lower index indicates worse health.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.|||scores on a scale||Standard Deviation|Mean
2674813|NCT01453049|Secondary|Percent Change From Baseline in High Sensitivity C-reactive Protein (Hs-CRP) at Week 24/EW|Blood samples of participants were collected for hs-CRP assessment. CRP is a marker of inflammation. High levels of CRP predict the risk of heart disease and diabetes. Percent change from Baseline in hs-CRP was calculated as the value at Visit 8 (Wk 24)/ EW minus the value at Baseline divided by value at Wk 24/ EW multiplied by 100.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.|||percent change||Full Range|Median
2674814|NCT01453049|Secondary|Change From Baseline in High Sensitivity C-reactive Protein (Hs-CRP) at Week 24/EW|Blood samples of participants were collected for hs-CRP assessment. CRP is a marker of inflammation. High levels of CRP predict the risk of heart disease and diabetes. Change from Baseline in hs-CRP was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.|||mmol/L||Standard Deviation|Mean
2674815|NCT01453049|Secondary|Change From Baseline in the Ratio of TC/HDL-C and LDL-C/HDL-C at Week 24/EW|Blood samples of participants who had fasted for 12 to 14 hours were collected for lipid profile (TC, HDL-C and LDL-C) assessment. The ratio of TC/HDL-C and LDL-C/HDL-C was calculated. Change from Baseline in the ratio of TC/HDL-C and LDL-C/HDL-C was calculated as the value at Week 24/EW minus the value at Baseline. For TC/HDL-C, the numerator is TC, and the denominator is HDL-C. For LDL-C/HDL-C, the numerator is LDL-C, and the denominator is HDL-C.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.|||ratio||Standard Deviation|Mean
2674816|NCT01453049|Secondary|Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Chloride, Calcium, and Phosphorus at Week 24/EW|Blood samples of participants were collected for BUN and electrolyte (sodium, potassium, chloride, calcium, and phosphorus) assessment. The electrolyte balance asseses the condition of the heart and the kidneys, and BUN assesses the condition of the kidneys. Change from Baseline in BUN, sodium, potassium, chloride, calcium, and phosphorus was calculated as the value at Week 24/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|Safety Population: all participants who received at least one dose of study medication. Only those participants contributing data at the indicated time points were analyzed.|||mmol/L||Standard Deviation|Mean
2674817|NCT01453049|Secondary|Change From Baseline in Total Cholesterol (TC), High Density Lipoprotein-cholesterol (HDL-C), Low Density Lipoprotein-cholesterol (LDL-C), and Triglyceride (TG) at Week 24/EW|Blood samples of participants who had fasted for 12 to 14 hours were collected for lipid profile (TC, HDL-C, LDL-C, TG) assessment. The lipid profile asesses the risk of heart disease. Change from Baseline in TC, HDL-C, LDL-C, and TG was calculated as the value at Week 24)/EW minus the value at Baseline.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.|||mmol/L||Standard Deviation|Mean
2674818|NCT01453049|Secondary|Number of Participants at Various Dose Levels at Week 24/EW|The number of participants at the different dose levels at Week 24/EW was recorded. The different dose levels for Rosi + Glim are: Dose level 1, Rosi 4 mg + Glim 1 mg; Dose level 2, Rosi 4 mg + Glim 2 mg; Dose level 3, Rosi 4 mg + Glim 4 mg. The different dose levels for Glim are: Dose level 1, Glim 1 mg; Dose level 2, Glim 2 mg; Dose level 3, Glim 4 mg.|Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed. Data were missing for one participant in the rosiglitazone+glimepiride FDC arm.|||participants|||Number
2674819|NCT01453049|Secondary|Change From Baseline in Homeostasis Model Assessment Beta-cell Function (HOMA-B) at Week 24/EW|Blood samples of participants who had fasted for 12 to 14 hours were collected for fasting glucose (FG) and insulin (FI) assessment. The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA-B is calculated using the following mathematical model to predict glucose and insulin concentrations=(20*FI[mU/ml])/(FG[mmol/l]-3.5).|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.|||Ratio: 20*FI (num.); FG-3.5 (denom.)||Standard Deviation|Mean
2674820|NCT01453049|Secondary|Change From Baseline in Homeostasis Model Assessment Sensitivity (HOMA-S) at Week 24/EW|Blood samples of participants who had fasted for 12-14 hours were collected for fasting glucose (FG) and insulin (FI) assessment. The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA-S is calculated using the following model to predict glucose and insulin concentrations=(FI[milliunits (mU)/milliliter (ml)]*FG [millimoles per liter (mmol/l)])/22.5. numerator, num.; denominator, denom.|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.|||Ratio: FI*FG (num.); 22.5 (denom.)||Standard Deviation|Mean
2674821|NCT01453049|Secondary|Change From Baseline in Fasting Proinsulin and Insulin at Week 24/Early Withdrawal (EW)|Blood samples of participants who had fasted for 12-14 hours were collected for fasting proinsulin (precursor of insulin) and insulin assessment. Preproinsulin is sequentially processed via proinsulin, through intermediate proteolytic cleavage products, to insulin and C-peptide before release from the beta cell granule by exocytosis. Elevated levels of proinsulin are considered indicative of beta cell dysfunction. Insulin is a hormone that regulates carbohydrate and fat metabolism in the body. Change from Baseline was calculated as the value at Week 24/ EW minus the value at Baseline (Week 0).|Baseline (Week 0) and Week 24/EW|FAS. Only those participants contributing data at the indicated time points were analyzed.|||Picomoles per liter (pmol/L)||Standard Deviation|Mean
2674822|NCT01453049|Secondary|Number of Participants Who Achieved HbA1c <7%, HbA1c <=6.5%, or Who Achieved a Decrease of >=0.7% From Baseline|Blood samples of participants were collected for HbA1c assessment.|Baseline (Week 0) and Week 24 (LOCF)|FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
2674871|NCT01452425|Primary|Comparison Between INVOS Monitoring and Electromyography|"A comparison will be made between the INVOS monitoring and non invasive (transcutaneous) EMG monitoring (AP Block), to determine the accuracy of the INVOS monitoring to predict AP block.~Measures were:~[mean (SD)] INVOS (in %) value at baseline and at the time of the block"|45 minutes||||% of StcO2||Standard Deviation|Mean
2674823|NCT01453049|Secondary|Number of FPG Responders and Non-responders|Blood samples of participants were collected for FPG assessment. FPG responders are definded as participants who had a >=1.7 mmol/L decrease from Baseline FPG or who achieved a FPG level < 6.1 mmol/L at Week 24 (LOCF).|Baseline (Week 0) and Week 24 (LOCF)|FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
2674824|NCT01453049|Secondary|Number of HbA1c Responders and Non-responders|Blood samples of participants were collected for HbA1c assessment. HbA1c responders were defined as participants who had achieved HbA1c <7%, or who achieved a decrease of >= 0.7% from Baseline at Week 24 (LOCF).|Baseline (Week 0) and Week 24 (LOCF)|FAS. Missing values were imputed using the LOCF method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.|||participants|||Number
2674825|NCT01453049|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Blood samples of participants were collected for FPG assessment. The FPG test, also known as the fasting blood sugar test, measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. Change from Baseline in FBG was calculated as the value at Week 24 minus the value at Baseline.|Baseline (Week 0) and Week 24|FAS. Missing values were imputed using the Last Observation Carried Forward (LOCF) method, i.e., the last available observation was used to estimate subsequent missing data points. Only those participants contributing data at the indicated time points were analyzed.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2674826|NCT01453049|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24|Blood samples of participants were collected for HbA1c assessment. HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The American Diabetes Association has recommended an HbA1c value below 53 millimoles per mole (mmol/mol) (7.0%) for most participants. Change from Baseline in HbA1c was calculated as the value at Week 24 minus the value at Baseline.|Baseline (Week 0) and Week 24|Full Analysis Set (FAS): all randomized participants who received >=1 dose of study medication and had >=1 post-Baseline efficacy assessment. Missing values were imputed using Last Observation Carried Forward (used to estimate subsequent missing data points). Only those participants contributing data at the indicated time points were analyzed.|||Percent of total hemoglobin||Standard Deviation|Mean
2674827|NCT01453036|Primary|Helicobacter Pylori Eradication Rate|Eradication was determined by the C13-urea breath test 6 to 8 weeks after the eradication therapy when PPIs had not been used for at least 2 weeks.|8 weeks|Each convential AOC, AOM group : 308 patients Mutation test gorup : H. pylori was not detected by PCR 90 patient , total 218 patient predicted prevalence – 50%, expected dropout rate -15%, predicted eradication rate – 80%, significance level - 0.05, statistical power - 90%|||percentage of participants||95% Confidence Interval|Number
2674828|NCT01453023|Secondary|Ex-throat Dose (ETD) and ETD <2 Microns on Day 14 of the Respective Treatment Period|"The ex-throat dose (ETD) and the nominal ETD is the mass (micrograms) of active investigational material that passes beyond the throat, nominal being the mean. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted ETD and ETD <2 microns."|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||micrograms||Standard Deviation|Mean
2674829|NCT01453023|Secondary|Total Emitted Dose (TED) on Day 14 of the Respective Treatment Period|The total emitted dose (TED) is defined as the mass (micrograms) of the nominal dose that passes beyond the throat. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted total emitted dose.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||micrograms||Standard Deviation|Mean
2674830|NCT01453023|Secondary|Peak Pressure Drop on Days 1 and 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Peak pressure drop is defined as the maximum pressure drop (kilopascal [kPa]) achieved during inhalation across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was calculated for each day (Days 1 and 14 of the respective treatment period), and used for subsequent modeling and prediction of dose emission attributes.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Kilopascal (kpa)||Standard Deviation|Mean
2674872|NCT01452412|Secondary|Quality of Life - Physical Function Domain|Short Form- 36 (SF-36) will be performed in all participants. We will evaluate effects on the Physical Function Domain. The Physical Function Domain is scored from 0 to 100 with higher scores meaning better physical functioning.|2 year||||score on a scale||Standard Deviation|Mean
2674873|NCT01452412|Secondary|Estimated GFR|Estimated GFR|2 year||||ml/min/1.73m2||Standard Deviation|Mean
2674831|NCT01453023|Secondary|Inhaled Volume on Days 1 and 14 of the Respective Treatment Period|"During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhaled volume is defined as the volume of air (Liters) inhaled during the inhalation across the resistance of the inhaler.~The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalaled volume was determined."|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters||Standard Deviation|Mean
2674832|NCT01453023|Secondary|Inhalation Time on Days 1 and 14 of of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhalation time is defined as the duration of the inhalation(s) when inhaling across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalation time was determined.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Seconds (sec)||Standard Deviation|Mean
2674833|NCT01453023|Secondary|Average Flow Rate and Peak Inspiratory Flow Rate (PIFR) on Day 1 and Day 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Average flow rate is defined as the average inspiratory flow rate (Liters [L]/min) across the inhalation profile when inhaling across the resistance of the inhaler. PIFR is defined as the Peak Inspiratory Flow Rate (L/min) of the inhalation profile when inhaling across the resistance of the inhaler.The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the average flow rate and PIFR were determined.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters per minute (L/min)||Standard Deviation|Mean
2674834|NCT01453023|Secondary|Oropharyngeal Volume on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Oropharyngeal volume is defined as the volume (cm^3) of the mouth and throat estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters per minute (L/min)||Standard Deviation|Mean
2674835|NCT01453023|Secondary|Distance of Assessment on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Distance of assessment is defined as the distance (length measured in centimeters [cm]) estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||centimeters (cm)||Standard Deviation|Mean
2674836|NCT01453023|Secondary|Average Oropharyngeal Cross-sectional Area on Day 1 and Day 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for the study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Pharyngometry data were recorded for each day (Day 1 and Day 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Day 1 and Day 14 of the respective treatment period (up to Study Day X)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||centimeters squared (cm^2)||Standard Deviation|Mean
2674855|NCT01453023|Primary|Hematocrit Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hematocrit at Day 14 of the respective treatment period. Hematocrit is a measure of the percentage of the volume of the whole blood that is composed of red blood cells, as determined by separation of red blood cells from the plasma (usually by centrifugation).|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||proportion of 1||Standard Deviation|Mean
2674837|NCT01453023|Secondary|Serum Cortisol (SC) Weighted Mean (0-12 Hours) on Day 14 of the Respective Treatment Period|"SC weighted mean was determined for each participant over the time period of 0-12 hours on Day 14 of the respective treatment period. SC weighted mean was derived by dividing the area under the concentration-time curve (AUC; defined as thearea under the concentration-time curve from time zero up to 24 hours) by the sample collection time interval. The sample collection time interval is defined as the difference between the time of the last cortisol sample and the time of the first cortisol sample. Samples were collected at the following time points: 0 (first blood draw/pre-dose); 2, 4, 8, and 12 hours (relative to the 0 time point). Weighted means were derived using the linear trapezoidal rule. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative time were used for these observations. Treatment and period were fitted as fixed effects and participant was fitted as a random effect."|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||nanomoles per Liter||95% Confidence Interval|Geometric Mean
2674838|NCT01453023|Secondary|Blood Glucose and Potassium Values on Day 14 of the Respective Treatment Period|Blood glucose and potassium values were measured on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose. Weighted means were derived using the linear trapezoidal rule. Actual relative times were used for the calculation except where actual times were missing. If any actual times were missing, planned relative time were used for these observations. Treatment and period were fitted as fixed effects and participant was fitted as a random effect.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimoles per liter (mmol/L)||95% Confidence Interval|Least Squares Mean
2674839|NCT01453023|Secondary|Tmax and Tlast of VI on Day 1 of the Respective Treatment Period|tmax is defined as the time to reach the observed maximum VI concentration, and tlast is defined as the time of the last observed quantifiable VI concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose.|Day 14 of the respective treatment period (up to Study Day 63)|VI PK Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the VI PK Population.|||hours||Full Range|Median
2674840|NCT01453023|Secondary|Cmax of VI on Day 14 of the Respective Treatment Period|Cmax is defined as the maximum observed concentration of VI on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose.|Day 14 of the respective treatment period (up to Study Day 63)|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.|||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
2674841|NCT01453023|Secondary|AUC(0-t) and AUC(0-4) of VI on Day 14 of the Respective Treatment Period|Area under the concentration-time (AUC) curve from time zero (pre-dose) to the last time AUC(0-t) and from time zero to 4 hours AUC(0-4) of quantifiable concentration of VI on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the VI PK Population.|Day 14 of the respective treatment period (up to Study Day 63)|VI PK Population: participants in the All Subjects Population for whom a PK sample was obtained and analyzed for VI.|||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
2674842|NCT01453023|Secondary|Tmax and Tlast of FF on Day 14 of the Respective Treatment Period|tmax is defined as the time to reach the observed maximum concentration, and tlast is defined as the time of the last observed quantifiable concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose.|Day 14 of the respective treatment period (up to Study Day 63)|FF PK Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.|||hours||Full Range|Median
2674843|NCT01453023|Secondary|Cmax of FF on Day 14 of the Respective Treatment Period|Cmax is defined as the maximum observed concentration of FF on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose.|Day 14 of the respective treatment period (up to Study Day 63)|FF PK Population. Only those participants available at the specified time points were analyzed.|||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
2674844|NCT01453023|Secondary|AUC(0-t) and AUC(0-4) of FF on Day 14 of the Respective Treatment Period|Area under the concentration-time (AUC) curve from time zero (pre-dose) to the last time AUC(0-t) and from time zero to 4 hours AUC(0-4) of quantifiable concentration of FF on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 10 minutes (min) and 30 min post-dose; and 1, 2, and 4 hours post-dose. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PK Population.|Day 14 of the respective treatment period (up to Study Day 63)|FF Pharmacokinetic (PK) Population: participants in the All Subjects Population for whom a PK sample was obtained and analyzed for FF.|||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
2674874|NCT01452412|Secondary|Hand-grip Strength|Hand-grip strength will be measured in all participants|2 year||||kg||Standard Deviation|Mean
2674875|NCT01452412|Primary|DEXA of Wrist|The investigators will evaluate changes in bone mineral density at the wrist.|2 year||||g/cm2||Standard Deviation|Mean
2674845|NCT01453023|Primary|Maximum QTcF at Day 1 and Day 14 of the Respective Treatment Period|QTcF is the QT domain corrected for heart rate by Fridericia's formula. Treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||milliseconds||Standard Error|Least Squares Mean
2674846|NCT01453023|Primary|Change From Baseline in Heart Rate at Day1 and Day 14 of the Respective Treatment Period|Heart rate (HR) was measured at Day 1 and Day 14 of the respective treatment period. hr=hour. Baseline is defined as the pre-dose measurement at Day 1. Change from Baseline was calculated as the Day 14 value minus the Baseline value. Treatment, period, day (1 and 14), participant Baseline, period Baseline, and treatment*day interaction were fitted as fixed effects, and participant was fitted as a random effect.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Beats per minute||Standard Error|Least Squares Mean
2674847|NCT01453023|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Day 1 and Day 14 of the Respective Treatment Period|SBP and DBP were measured at Day 1 and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1. Change from Baseline was calculated as the Day 14 value minus the Baseline value.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2674848|NCT01453023|Primary|Peak Expiratory Flow on Day 1 and Day 14 of the Respective Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF is calculated as the maximum of three readings taken at each timepoint for each participant. Baseline is defined as the maximum pre-dose measurement at Day 1 for each period.|Day 1 and Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||liters/minute||Standard Deviation|Mean
2674849|NCT01453023|Primary|Total Bilirubin, Direct Bilirubin, Creatinine, and Uric Acid Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of total bilirubin, direct bilirubin, creatinine, and uric acid at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2674850|NCT01453023|Primary|Calcium, Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of calcium, chloride, carbon dioxide content/bicarbonate (CO2/BI), glucose, potassium, sodium, and urea/BUN at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2674851|NCT01453023|Primary|Albumin and Total Protein Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of albumin and total protein at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter||Standard Deviation|Mean
2674852|NCT01453023|Primary|Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||International units per liter (IU/L)||Standard Deviation|Mean
2674853|NCT01453023|Primary|Mean Corpuscle Hemoglobin (MCH) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCH at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||10^12 picograms (pg) per cell||Standard Deviation|Mean
2674854|NCT01453023|Primary|Mean Corpuscle Volume (MCV) Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCV at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||10^15 femtoliters (fL) per cell||Standard Deviation|Mean
2674876|NCT01452412|Primary|Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times|Sit to stand to sit x10 speed (time to perform sit to stand to sit 10 times) will be measured and compared between groups.|2 year||||seconds||Standard Deviation|Mean
2674856|NCT01453023|Primary|Reticulocyte and Red Blood Cell (RBC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of reticulocytes and RBCs at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
2674857|NCT01453023|Primary|Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hemoglobin and MCHC at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter (g/L)||Standard Deviation|Mean
2674858|NCT01453023|Primary|Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil, Platelet, and White Blood Cell Count Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelets, and white blood cell (WBC) count at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 63)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
2674859|NCT01453023|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Week 11 (Visit 9)/Early Withdrawal|All Subjects Population: all participants who received at least one dose of study medication|||Participants|||Number
2674860|NCT01452854|Primary|Ovarian Aging (AFC and Hormones)|Transvaginal Ultrasound will be use to measure Antral Follicle Counts (AFC) and blood will be drawn to measure hormones (FSH, LH, estradiol, estrone, AMH, SHBG, testosterone, and inhibin B).|Every 3 months for 1 year|Data collection was terminated and analyses were not performed due to low enrollment||||||
2674861|NCT01452789|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Adverse events will be collected, graded by severity, and assessed for causality referent to study drug.|Patients will be followed for the duration of hospital stay, an expected average of 5 weeks.|Intention to treat|||Participants|||Count of Participants
2674862|NCT01452789|Secondary|Number of Patients Requiring Supplemental Phenobarbital Treatment.|This endpoint will compare requirement number of patients who require use of supplemental phenobarbital.|Patients will be followed for the duration of hospital stay, an expected average of 5 weeks.|Intention to treat|||participants|||Number
2674863|NCT01452789|Secondary|Length of Hospitalization|This endpoint will compare length of stay in the hospital (in days) using sublingual buprenorphine or morphine solution.|Duration of hospital stay is an expected average of 5 weeks.|Intention to treat|||days||Full Range|Median
2674864|NCT01452789|Primary|Length of Treatment|This endpoint will compare length of treatment (in days) using sublingual buprenorphine or oral morphine solution.|Patients will be followed for the duration of hospital stay, an expected average of 5 weeks.|Intention to treat|||days||Full Range|Median
2674865|NCT01452529|Secondary|Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline|A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the mean pain intensity at week 12 of the double-blind period.|Baseline to Week 12|The full analysis population (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||Participants|||Number
2674866|NCT01452529|Secondary|Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline|A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the mean pain intensity at week 12 of the double-blind period.|Baseline to Week 12|The full analysis population (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||Participants|||Number
2674867|NCT01452529|Secondary|Patient Global Impression of Change (PGIC)|"The PGIC is an ordinal scale which assesses the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse), where 1 = very much improved and 7 = very much worse. The proportion of subjects responding very much improved and much improved was summarized by treatment group."|Week 12|The full analysis population (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||Participants|||Number
2674868|NCT01452529|Secondary|Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R) - Sleep Disturbance Subscale|"The MOS Sleep-R is a brief, self-administered 12-item assessment designed to measure key aspects of sleep. It includes a sleep problems index and 6 subscales - sleep disturbance, sleep adequacy, daytime somnolence, snoring, awaken short of breath or with headache, and quantity of sleep. The sleep disturbance subscale comprised the responses to questions 1, 3, 7, and 8 on the assessment. The individual responses for each question were recorded on a 5-point scale with options ranging from 1 - all of the time to 5 - none of the time. Sleep disturbance scores were transformed linearly on a scale of 0-100. A higher value indicates a better score; therefore, a higher score indicates a better sleep pattern."|Weeks 4, 8, and 12|The full analysis population (N = 588) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||units on a scale||Standard Deviation|Mean
2674877|NCT01452347|Secondary|Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at End of Trial (EoT) Week 12|Percentage of patients with observed Ctrough,ss value < 50 ng/mL (As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients) This outcome measure was only analysed for all patients together and not by dose group.|Week 12|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.|||percentage of participants|||Number
2674878|NCT01452347|Secondary|Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 4|Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.|Week 4|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.|||percentage of participants|||Number
2674879|NCT01452347|Secondary|Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 2|Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.|Week 2|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.|||percentage of participants|||Number
2674880|NCT01452347|Secondary|Percentage of Patients With Observed Trough Dabigatran Plasma Concentrations < 50 ng/mL at Week 1|Percentage of patients with observed Ctrough,ss value < 50 ng/mL are presented. This outcome measure was only analysed for all patients together and not by dose group.|Week 1|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.|||percentage of participants|||Number
2674881|NCT01452347|Primary|Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at End of Trial (EoT) at Week 12|"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).~(As the trial was stopped prematurely, EOT may not be 12 weeks after randomisation for most of the patients)~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population."|Week 12|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2674882|NCT01452347|Primary|Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 4|"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population."|Week 4|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2674883|NCT01452347|Primary|Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations (C Trough,ss) at Week 2|"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE).~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population."|Week 2|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2674884|NCT01452347|Primary|Comparison of Observed and Predicted Trough Dabigatran Plasma Concentrations at Steady State (C Trough,ss) at Week 1|"Comparisons between dabigatran trough plasma levels as predicted by simulations to those observed in the study are performed to validate the dosing algorithm for Dabigatran Etexilate (DE) .~Despite the primary endpoint only being assessed in patients who received dabigatran etexilate, Warfarin was included as a comparator treatment in this study in order to facilitate informal comparisons of outcome events, and to look for efficacy signals in this previously unexplored population."|Week 1|Pharmacokinetic set (PKS):Patients were included in the PKS if they were treated with DE, had at least 1 evaluable C trough,ss value and had a non-missing value for gender, age and Creatinine clearance(CrCl) level. Patients who had any important Protocol Violations that may have affected PK data were excluded from the PKS.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2674885|NCT01452269|Primary|Change in Physical Activity Assessment (PAA) Score|We measured the mean change in the moderate PAA score for the immediate and delayed groups, from baseline to 6 months (post-intervention for the immediate group; no intervention yet for the delayed group). We used intention to treat analyses, with any missing values carried forward from baseline to the 6-month data point. PAA moderate activity scores range from 0-27; higher scores are better (more physical activity).|Baseline and 6 months||||moderate PAA score||Standard Error|Mean
2674908|NCT01451931|Primary|Cumulative Radiation Exposure||Baseline plus 6 months post-baseline||||mSv||Standard Deviation|Mean
2674886|NCT01452269|Primary|Change in Dietary Risk Assessment (DRA) Score|We measured the mean change in DRA score for the immediate and delayed groups, from baseline to 6 months (post-intervention for the immediate group; no intervention yet for the delayed group). We used intention to treat analyses, with any missing values carried forward from baseline to the 6-month data point. DRA scores range from 0-96; lower scores are better (improved dietary quality).|Baseline and 6 months||||DRA score||Standard Error|Mean
2674887|NCT01452269|Primary|Weight Change|We measured the mean change in weight for the immediate and delayed groups, from baseline to 6 months (post-intervention for the immediate group; no intervention yet for the delayed group). We used intention to treat analyses, with any missing values carried forward from baseline to the 6-month data point.|Baseline and 6 months||||kilograms||Standard Error|Mean
2674888|NCT01452191|Secondary|The Number of Children's Centres Providing Information and Advice on Bedtime Routines to Prevent Fires||1 year|Analysis at level of Children's centres. Data on this outcome was missing for one Children's centre in the Injury Prevention Briefing and Facilitation arm and one Children's centre in the Usual Care arm.|||Children's centres|Children's centres||Count of Units
2674889|NCT01452191|Secondary|The Number of Children's Centres Providing Information and Advice on Child Behaviour and Fire Prevention||1 year||||Children's centres|Children's centres||Count of Units
2674890|NCT01452191|Secondary|The Number of Children's Centres Providing Information and Advice on the Causes of House Fires||1 year|Analysis at level of Children's centres|||Children's centres|Children's centres||Count of Units
2674891|NCT01452191|Secondary|The Number of Children's Centres Providing Information and Advice on How to Make a Fire Escape Plan||1 year|Analysis at level of Children's centres. Data on this outcome was missing for one Children's centre in the Usual Care arm.|||Children's centres|Children's centres||Count of Units
2674892|NCT01452191|Secondary|The Number of Childrens Centres Providing Information and Advice on Smoke Alarms||1 year|Analysis based at level of Children's centres. Data on this outcome was missing for one Children's centre in the Injury Prevention Briefing only arm.|||Children's centres|Children's centres||Count of Units
2674893|NCT01452191|Primary|Number of Families With a Fire Escape Plan (Ascertained From Self-completion Questionnaire).||1 year|Data on this outcome was missing for 5 participants in the Injury Prevention Briefing and Facilitation arm, 9 in the Injury Prevention Briefing only arm and 4 in the Usual Care arm.|||Participants|||Count of Participants
2674894|NCT01452152|Secondary|Composite of All-cause Death, Myocardial Infarction (MI), Stroke and Repeat Revascularization||One year||||participants|||Number
2674895|NCT01452152|Secondary|Occurrence of Adverse Events|The number of subjects reporting any AEs will be tabulated.|One year||||participants|||Number
2674896|NCT01452152|Secondary|Health Care Resource Utilization and Cost-effectiveness||One year|This outcome measure has zero total participants analyzed because health care resource utilization and cost-effectiveness data was not collected due to the early termination of the trial.||||||
2674897|NCT01452152|Secondary|Post-treatment Platelet Aggregation|Platelet aggregation will be performed on a subset of subjects using VerifyNow P2Y12 which measures platelet reactivity due to the effect of a P2Y12. Values less than 180 P2Y12 Reaction Units (PRU) suggest evidence of a P2Y12 inhibitor effect. Platelet aggregation studies are optional and will not be used to modulate antiplatelet therapy.|10 days|Optional platelet aggregation was performed in 3 of 5 participants randomized to the Genotype-directed, clopidogrel arm and 0 of 4 participants randomized to the Standard of Care arm.|||percentage of inhibition||Standard Deviation|Mean
2674898|NCT01452152|Secondary|Occurrence of Bleeding Events|Bleeding events will classified by the Bleeding Academic Research Consortium definition. The number of bleeding events will be tabulated.|One year||||events|||Number
2674899|NCT01452152|Primary|Occurrence of Post-randomization Cardiovascular Events|Cardiovascular events include non-fatal myocardial infarction, non-fatal stroke, definite or probable stent thrombosis (ARC definition) and death secondary to any cardiovascular cause.|One year||||participants|||Number
2674900|NCT01452126|Secondary|Number of Patients With Complications|All patients were followed up for complications such as bleeding, infection, side effects, nerve damage|3 days||||Participants|||Count of Participants
2674901|NCT01452126|Primary|Effective Concentration of Ropivacaine to Produce Surgical Anesthesia in 50% of Population|The concentration of ropivacaine for each patient's nerve-block injection was determined per protocol.|1 day||||percentage concentration, ropivacaine|||Number
2674902|NCT01451996|Secondary|Change in Wheal Reaction Area From Baseline --- 1 Hour|A research technician, blinded to the subject's condition, measured the extent of the skin inflammation at baseline and 1 hour post Claritin administration by tracing the wheal reaction after the histamine challenge (i.e. the slightly reddened, elevated area at the site of the challenge, a well-established measure of histamine response). The percentage change in the wheal reaction was calculated as the change (decrease) in the size relative to baseline, multiplied by 100. Wheal area was measured in mm^2.|baseline and 1 hours post administration of Claritin||||Percent change||Standard Error|Mean
2674903|NCT01451996|Primary|Change in Wheal Reaction Area From Baseline --- 2 Hour|A research technician, blinded to the subject's condition, measured the extent of the skin inflammation at baseline and 2 hours post Claritin administration by tracing the wheal reaction after the histamine challenge (i.e. the slightly reddened, elevated area at the site of the challenge, a well-established measure of histamine response). The percentage change in the wheal reaction was calculated as the change (decrease) in the size relative to baseline, multiplied by 100. Wheal area was measured in mm^2.|baseline and 2 hours post administration of Claritin.||||Percent change||Standard Error|Mean
2674904|NCT01451983|Primary|Total Brain Volume||Baseline|MRI acquisition was performed using Siemens Q4 TIM Trio 3 tesla scanner with standard 12-channel receive-only head coil. An 8-minute whole-brain T1-weighted inversion recovery turboflash (MPRAGE) was acquired. Volumetric measurements were obtained using the software suite Freesurfer. Not all participants received imaging due to age and impairment.|||cubic centimeters||Standard Deviation|Mean
2674905|NCT01451931|Secondary|Accuracy for Stones by Arm||Up to 6 month follow-up for stone passage||||Percent probability||95% Confidence Interval|Number
2674906|NCT01451931|Secondary|Return Visits to ED or Hospital||6 months post-baseline||||Number of visits|||Number
2674907|NCT01451931|Secondary|ED Length of Stay||Baseline visit excluding hospitalization||||Hours||Inter-Quartile Range|Median
2674909|NCT01451931|Primary|High Risk Diagnosis With Complication|Missed or delayed diagnosis of appendicitis, pneumonia with sepsis, diverticulitis, abdominal aortic aneurysm with rupture, mesenteric ischemia with bowel perforation, renal infarction, stone with renal abscess, urosepsis/pyelonephritis with bacteremia, ovarian torsion with necrosis related to randomization and due to imaging modality.|30 days from baseline||||participants|||Number
2674910|NCT01451827|Secondary|Percent Change From Baseline in TKV at Week 8.|Total kidney volume is an important measure of disease progression. A 3-week time point is adequate to assess acute effects on kidney cyst shrinkage.|Baseline to Week 8|The core patient population for all efficacy analyses was based on the intent-to-treat (ITT) population which consisted of all randomized participants who take at least one dose of study drug. Observed Cases (OC) dataset within treatment period was defined as the data observed at study specified visits while subjects are taking study drug.|||Percentage change||Standard Deviation|Mean
2674911|NCT01451827|Secondary|Change From Baseline in Total Score of the Autosomal Dominant Polycystic Kidney Disease Urinary Impact Scale (ADPKD-UIS)|The ADPKD-UIS was a self-administered questionnaire designed to measure ADPKD-related urinary symptoms in participants with ADPKD. This instrument contained 11 items in 3 domains (Urinary Frequency, Urinary Urgency, and Nocturia). Each item was scored using a scale of 1 to 5 (a higher score indicated increased difficulty/extremely bothered). The maximum total score is 55; 1: not difficult/not bothered at all; 55: extremely difficult/extremely bothered.|Baseline to Week 8|Participants who were randomized and had baseline and post-baseline observations in the total renal volume.|||Unit on a scale||Standard Deviation|Mean
2674912|NCT01451827|Primary|Percent Change From Baseline in Total Kidney Volume (TKV) at Week 3|The primary endpoint was percent change from baseline in TKV at Week 3. Total kidney volume is an important measure of disease progression. A 3-week time point is adequate to assess acute effects on kidney cyst shrinkage.|Baseline to Week 3|Participants who were randomized and had baseline and post-baseline observations in the total renal volume.|||Percentage change||Standard Deviation|Mean
2674913|NCT01451814|Primary|7-day Point Prevalence Smoking Abstinence at 26 Weeks|Biochemically verified abstinence from smoking over the past 7 days|26 Weeks||||percentage of participants abstinent|||Number
2674914|NCT01451814|Primary|7-day Point Prevalence Smoking Abstinence at 16 Weeks|Biochemically verified abstinence from smoking over the past 7 days|16 Weeks||||percentage of participants abstinent|||Number
2674915|NCT01451814|Primary|7-day Point Prevalence Smoking Abstinence at 8 Weeks|Biochemically verified abstinence from smoking over the past 7 days|8 weeks||||percentage of participants abstinent|||Number
2674916|NCT01451775|Secondary|Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator.|Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry, haematology, urinanalysis and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events (AEs). Time frame for AE reporting includes the period of first drug administration until end of study. A more detailed definition of the used time frame and MedDRA Version can be found in the AE section.|Screening until end of trial, average of 45 days|Treated Set(TS): TS includes all subjects who have taken at least 1 dose of trial medication|||participants|||Number
2674917|NCT01451775|Primary|Maximum Measured Concentration (Cmax)|"Maximum measured concentration of empagloflozin (empa) in plasma, per period.~The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities."|1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|All treated subjects who provided at least one observation in the relevant treatment periods for at least one primary pharmacokinetic (PK) endpoint without a relevant protocol deviation and who had not experienced emesis before or at 2 times median tmax in at least one of the two relevant treatment periods.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2674918|NCT01451775|Primary|Area Under the Curve 0 to Infinity (AUC0-∞)|"Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 hours extrapolated to infinity (AUC0-∞).~The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities."|1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration|All treated subjects who provided at least one observation in the relevant treatment periods for at least one primary pharmacokinetic (PK) endpoint without a relevant protocol deviation and who had not experienced emesis before or at 2 times median tmax in at least one of the two relevant treatment periods.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2674919|NCT01451762|Primary|Quality of Recovery 40 at 24 Hours|Scores on QOR (quality of recovery) 40 questionnaire.The QoR-40 score, which ranges from 40 to 200, representing very poor to outstanding quality of recovery, respectively.|24 hours post operatively|Primary outcome was QOR 40 a sample size of 23 per group was estimated to achieve 80% power to detect a 10 point difference in aggregated QOR040 score for the three groups. A 10 point difference represents a clinically relevant improvement in quality of recovery. TO account for drop outs lost to follow up 90 subjects were randomized.|||units on scale 40 (low) - 200 (high)||Inter-Quartile Range|Median
2674920|NCT01451749|Secondary|Change in Functional Scores: Instrumental Activities of Daily Living (IADL).|Functional ability was evaluated with the Instrumental Activities of Daily Living (IADL) IADL, at baseline (day 1 clinic visit), at the mid-study (week 12), and at the endpoint of treatment (week 24). The IADL contains eight items, which are the ability to use a telephone, shop, prepare food, run laundry, use modes of transportation, take responsibility for one's own medications, complete housekeeping, and handle finances,each items ranges from 1 to 4 points, 1 points means no problem, and 4 points means greater impairment in instumental acvtiveity of daily living.The total is sub of the eight items, and the total range of the IADL is 8-32 points, higher scores indicate greater impairments. The changes was calculted by weeks 24 minus baseline.|Baseline to weeks 24|The efficacy measurement were conducted in the intent-to-treat population, the ITT consist all randomized population who take at least one dose of medication and at least one primary efficacy evaluation on treatment.|||units on a scale||95% Confidence Interval|Mean
2674974|NCT01451411|Secondary|Population Pharmacokinetics: Volume of Distribution (Vd)|Based on conivaptan concentrations, the pharmacokinetics of the study population will be analyzed to determine median Vd|Up to Hour 60|Due to the terminated status of the study, pharmacokinetic samples were not analyzed.||||||
2674921|NCT01451749|Secondary|Change in Memory Scores: The Delayed Story Recall (DSR) Test From the Adult Memory and Information Processing Battery (AMIPB)|memory function was evaluated with the DSR subtest,at baseline (day 1 clinic visit), at the mid-study (week 12), and at the endpoint of treatment (week 24). The DSR is a tool which was designed to assess immediate registration of verbal information and retention over time. It contains six sub-tests: two verbal memory tests (one of which is a story recall), two visual memory tests and two information-processing tests. The story recall test includes immediate story recall (ISR) and delayed story recall (DSR). The DSR total score ranges from 0-56 points. Lowers score means higher impairment of memory.The Change in cognitive scores was calculated as 24 week minus the baseline.|Baseline and 24 weeks|The efficacy measurement was conducted of ITT patients. The intent-to-treat population (ITT) consist all randomized population who take at least one dose of medication and at least one primary efficacy evaluation on treatment.|||units on a scale||95% Confidence Interval|Mean
2674922|NCT01451749|Primary|Change in Cognitive Scores: Alzheimer Disease Assessment Scale-cognitive. Subscale (ADAS-cog)|Cognition was assessed with the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) , at baseline (day 1 clinic visit) and at 12-week intervals thereafter until week 24. The ADAS-cog was designed specifically to evaluate the severity of cognitive dysfunctions characteristic of AD patients and includes 11 items. Among these items, memory, orientation, language function, practical ability, and attention are evaluated. The score on the ADAS-cog range from 0 to 70 point, with 0 point indicating no impairment and 70 points indicating severe impairment of cognition. In the Shenwu capsule group, the ADAS-cog score is ranges 3-38.3 points, and 3.3-30.7 points in the Donepezil group. The Change in cognitive scores was calculated as24 week minus the baseline.|baseline and 24 weeks|the analyses for efficacy were conducted in the intent-to-treat population (ITT). The intent-to-treat population (ITT) consist all randomized population who take at least one dose of medication and at least one primary efficacy evaluation on treatment.|||units on a scale||95% Confidence Interval|Mean
2674923|NCT01451723|Secondary|Brain Atrophy|Difference between the two groups in brain atrophy as measured by SIENA|1 year|||||||
2674924|NCT01451723|Primary|Rate of Change in NAA Levels Adjusted for Water Content.|The rate of change will be calculated using all the time points available )baseline, 6 and 12 months) using a mixed model analysis with the Log NAA as the dependent variable and water content, %grey matter, %white matter, %CSF and % lesion volume as covariates. All the voxels available for each subject where estimates have a SD <30 will be used. A spatial anysotropic exponential covariance structure will be used.|1 year|No subjects completed either the six or twelve month point so no data was available for analysis.||||||
2674925|NCT01451645|Secondary|Mean Number of Gout Flare Days Per Participant Assessed From Day 1 to Week 16||Day 1 to Week 16|Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).|||days||Standard Deviation|Mean
2674926|NCT01451645|Secondary|Percentage of Participants With at Least 2 Gout Flares From Day 1 to Week 16||Day 1 to Week 16|Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).|||Percentage of Participants||95% Confidence Interval|Number
2674927|NCT01451645|Secondary|Percentage of Participants With at Least 1 Gout Flare From Day 1 to Week 16||Day 1 to Week 16|Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).|||Percentage of Participants||95% Confidence Interval|Number
2674928|NCT01451645|Primary|Number of Gout Flares Per Participant From Day 1 to Week 16||Day 1 to Week 16|Efficacy endpoints were analyzed using the FAS. The full analysis set (FAS) included all randomized patients who received any study drug; it is based on the treatment allocated (as randomized).|||gout flares||Standard Deviation|Mean
2674929|NCT01451632|Secondary|Immunogenicity|Samples were collected to determine the presence of an immunologic reaction to MM-121 (i.e. human anti-human antibodies).|Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 48.1 weeks, and a collection was made post-infusion in any case of infusion reaction|||||||Number
2674930|NCT01451632|Secondary|Pharmacokinetic Parameters of MM-121|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first six weeks of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the AUClast. Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2)|Collections taken for all patients at Cycle 1, Week 1 at pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121|Data presented by dose level of MM-121, regardless of the cohort (i.e. 15 patients in Part 1 were administered the 40/20 dose level of MM-121: 3 in cohort 3b, 4 in cohort 4, and 8 in the Part 1 expansion)|||hr* ug/mL||Geometric Coefficient of Variation|Geometric Mean
2674931|NCT01451632|Secondary|Pharmacokinetics|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first six weeks of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2)|Collections taken for all patients at Cycle 1, Week 1 at pre-infusion, at the end of the infusion, and 2.5, 4, 6 and 24 hours after starting the infusion of MM-121||||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2674932|NCT01451632|Secondary|Objective Response Rate|To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >20% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline. Objective Response is presented as the total # patients with PR or CR.|Patients were assessed for objective response from time of first dose through treatment termination, the longest treatment duration being 48.1 weeks||||participants with objective response|||Number
2674933|NCT01451632|Primary|To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s): Cetuximab and Irinotecan|"Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. RP2D = one dose lever lower than the MTD~Part 1:~Cohort 1: MM-121: 12 mg/kg MM-121 QW + Cetuximab: 400 mg/m2 loading dose/200 mg/m2 (400/200) QW maintenance Cohort 2a: MM-121: 20 mg/kg IV QW + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 2b: MM-121: 12 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 3a: MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW (40/20) + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 3b: MM-121 20 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 4: MM-121: 40/20 mg/kg IV QW + Cetuximab: 400 / 250 mg/m2 maintenance IV QW~Part 2:~Cohort 1: MM-121: 20 mg/kg IV QW + Cetuximab: 400/200 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2 IV Q2W Cohort 2: MM-121: 40 / 20 mg/kg IV QW + Cetuximab: 400/250 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2"|From date of first dose to 30 days after termination, the longest 48.1 weeks|Number of patients participating in dose-escalation portion (excluding expansion cohort patients who were not evaluated for DLTs and thus not included in determining MTD/RP2D) NOTE: MTD of MM-121 provided in separate endpoint entry|||mg/m2|||Number
2674934|NCT01451632|Primary|To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s) (Via Recording of Maximum Tolerated Dose (MTD)): MM-121 Doses|"Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. RP2D = one dose lever lower than the MTD~Part 1:~Cohort 1: MM-121: 12 mg/kg MM-121 QW + Cetuximab: 400 mg/m2 loading dose/200 mg/m2 (400/200) QW maintenance Cohort 2a: MM-121: 20 mg/kg IV QW + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 2b: MM-121: 12 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 3a: MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW (40/20) + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 3b: MM-121 20 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 4: MM-121: 40/20 mg/kg IV QW + Cetuximab: 400 / 250 mg/m2 maintenance IV QW~Part 2:~Cohort 1: MM-121: 20 mg/kg IV QW + Cetuximab: 400/200 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2 IV Q2W Cohort 2: MM-121: 40 / 20 mg/kg IV QW + Cetuximab: 400/250 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2"|From date of first dose to 30 days after termination, the longest 48.1 weeks|Number of patients participating in dose-escalation portion (excluding expansion cohort patients who were not evaluated for DLTs) MTD of cetuximab and irinotecan for the combination(s) are presented in a separate endpoint entry|||mg/kg|||Number
2674935|NCT01451632|Primary|Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Cetuximab and the MM-121 Plus Cetuximab Plus Irinotecan Combination|To establish the safety of escalating doses of MM-121 in combination with cetuximab or in combination with cetuximab and irinotecan in order to determine the recommended phase 2 dose.. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.|From date of first dose to 30 days after termination, the longest 48.1 weeks|Patients participating in dose escalation|||participants reporting DLTs|||Number
2674936|NCT01451606|Secondary|Change in Endometriosis Health Profile - 30 Subscale for Functional Limitations Due to Pain|This is a questionnaire assessment of functional limitations due to clinical pain. The range of scores for this subscale is 0-44. The measure is the change in score from baseline to end of treatment period. A greater number (change in score) is a better outcome.|Baseline and 8 weeks||||units on a scale||Standard Deviation|Mean
2674937|NCT01451606|Primary|Change in Rating of Spontaneous Pelvic Pain (0 -10 Scale).|The primary clinical efficacy measure is the change in spontaneous (non-evoked) pelvic pain from the baseline period to the end of treatment. This was assessed by using the 0-10 numerical pain ratings to derive the primary outcome variable of clinical pain intensity difference due to treatment. Larger values (greater changes in ratings) are better outcomes.|Baseline and 8 weeks||||units on a scale||Inter-Quartile Range|Median
2674938|NCT01451554|Primary|Weight Change at 6 Months|Weight change as a percentage of baseline at post 6 months.|6 months|Intent to treat population includes all randomzied subjects. Missing data were imputed using the last observation carried forward.|||percentage||Standard Deviation|Mean
2674939|NCT01451554|Secondary|Weight Change at 3 Months|Percentage change in weight at 3 months post study baseline|3 months|Intent to treat population includes all randomzied subjects. Missing data were imputed using the last observation carried forward.|||percentage||Standard Deviation|Mean
2674940|NCT01451541|Secondary|Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Weeks 0 -12||||percentage of subjects|||Number
2674941|NCT01451541|Secondary|Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Weeks 0 -12||||participants|||Number
2674942|NCT01451541|Secondary|Percentage of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs||Weeks 0 -12||||percentage of subjects|||Number
2674943|NCT01451541|Secondary|Number of Subjects Experiencing AEs, SAEs, and Discontinuations Due to AEs||Weeks 0 -12||||participants|||Number
2674944|NCT01451541|Secondary|Time to Maximal Effect [Time to >= 90% Maximum Difference From Placebo in LS Means (Days)]|The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between active ciclesonide nasal aerosol and placebo is at least 90% of the largest estimated difference.This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The time to achieve at least 90% of these estimated differences was calculated.|Weeks 0 -6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.|||Number of Days|||Number
2674945|NCT01451541|Secondary|Change From Baseline in Daily PRQLQ Overall Score at the End of the 12-week Double-blind Treatment Period|PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses.|Weeks 0 -12|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.|||units on a scale||Standard Error|Least Squares Mean
2674946|NCT01451541|Secondary|Change From Baseline in Daily Average Subject-reported AM iTNSS Averaged Over the First 6 Weeks of Double-blind Treatment|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 -6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2674947|NCT01451541|Secondary|Change From Baseline in Daily Average Subject-reported AM and PM iTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 -12|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.|||units on a scale||Standard Error|Least Squares Mean
2674948|NCT01451541|Secondary|Change From Baseline in Daily Average Subject-reported AM and PM rTNSS Averaged Weekly Over the 12-week Double-blind Treatment Period|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the twelve week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement|Weeks 0 -12|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2674949|NCT01451541|Secondary|Change From Baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score at the End of the First 6 Weeks of Double-blind Treatment|PRQLQ was developed to measure the functional problems (physical, emotional, and social) that are most troublesome to children with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation, and other symptoms). Children recalled how they were during the previous week and responded to each question on a 7-point scale (0 = not bothered to 6 = extremely bothered or 0 = none of the time to 6 = all of the time) for a total possible score of 138. The overall PRQLQ score is the mean of all 23 responses.|Weeks 0 -6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2674950|NCT01451541|Secondary|Change From Baseline in Average Daily Subject-reported AM and PM Instantaneous Total Nasal Symptom Scores (iTNSS) Averaged Weekly Over the First 6 Weeks of Double-blind Treatment|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0 -6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2674951|NCT01451541|Primary|The Change From Baseline in Average Daily Subject-reported AM and PM Reflective Total Nasal Symptom Scores (rTNSS) Averaged Weekly Over the First 6 Weeks of the Double-blind Treatment.|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement.|Weeks 0-6|The Intent to Treat (ITT) population: All randomized subjects who received at least one dose of double blind study medication.Subjects with either missing baseline data or postdose data, or both and were not included in the analysis.|||units on a scale||Standard Error|Least Squares Mean
2674952|NCT01451463|Other Pre-specified|Six Condition Romberg Test|The Six Condition Romberg Test is used assess static balance. Subjects are tested standing with their arms crossed over their chests and are assessed for 30 seconds in the following 6 conditions: 1) feet together, 2) feet together eyes closed, 3) feet aligned in tandem heel-to-toe position eyes open, 4) feet aligned in tandem heel-to-toe position eyes closed, 5) standing in tandem position while counting backwards by 3's from 100 with eyes open, 6) standing in tandem position while counting backwards by 3's from 100 with eyes closed. Comparison of performances were made when off stable dose of tetrabenazine for > 18 hours to performance 2 hours after resumption of tetrabenazine. If a participant could not hold a stance for the full 30 seconds, then that component of the Romberg test ended at that point with the time of that component scored in seconds; 30 seconds being the maximum score for each of the 6 tests. The total score was calculated as a sum of all of the 6 subset scores.|>18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine||||Six Condition Romberg Test score||Standard Deviation|Mean
2674983|NCT01451398|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight from Baseline to Week 24|Baseline to Week 24|Full analysis set for patients with data at both Baseline and at Week 24|||kg||Standard Error|Least Squares Mean
2674953|NCT01451463|Secondary|Five Times Sit to Stand Test|Subjects are asked to sit in a chair with their arms across their chests and asked to stand and sit five times in a row. The time it takes to complete 5 sit to stand cycles is timed with a stop watch. Comparison is made when off stable dose of tetrabenazine for >18 hours to performance 2 hours after resumption of tetrabenazine. Lower time scores are associated with better balance.|>18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine||||seconds to complete 5 sit to stand cycle||Standard Deviation|Mean
2674954|NCT01451463|Primary|Tinetti Mobility Test Score|The Tinetti Mobility Test is a clinical test used to assess balance and gait. The Balance sub-score ranges from 0-16 (with 16 reflecting better balance) while the Gait sub-score ranges from 0-12 (with 12 reflecting better gait parameters). The Total Tinetti Mobility Test Score (TMT) is a sum of the two sub-scores with a maximum score of 28. The higher the score the better the gait and balance performance. A comparison of scores off regular stable dose of tetrabenazine for >18 hours with the performance two hours after resuming tetrabenazine was made.|>18 hours off Stable Dose of Tetrabenazine and at 2 hours after resumption of Tetrabenazine||||Total Tinetti Mobility Test Score (TMT)||Standard Deviation|Mean
2674955|NCT01451437|Secondary|Urine Concentration of MK-8242 (Part 2 Arm A Only)|The urine concentration of MK-8242 assessed as a measure of drug bioavailability was not determined due to early termination of the study (Study Part 2 was not performed).|Day 1 (predose and postdose) and Day 7 (postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (urine concentration) at the time of assessment||||||
2674956|NCT01451437|Secondary|Accumulation Ratio (R) of MK-8242 Alone and in Combination With Cytarabine|The accumulation ratio (R) at steady state (based on dosing interval and apparent terminal half-life (t1/2)) for MK-8242 alone was not determined due to confounding of results by significant concentrations of a drug metabolite (M16). Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1 Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (R) at the time of assessment.||||||
2674957|NCT01451437|Secondary|Apparent Terminal Half-life (t1/2) for MK-8242 Alone and in Combination With Cytarabine|Elimination phase t1/2 was determined for Cycle 1 Day 7 of MK-8242 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1 Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24, 48 hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (at least three time-points after Tmax).|||hr||Geometric Coefficient of Variation|Geometric Mean
2674958|NCT01451437|Secondary|Time to Maximum Concentration (Tmax) of MK-8242 Alone and in Combination With Cytarabine|Tmax was determined for Cycle 1 Days 1 and 7 of MK-8226 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (Tmax) at the time of assessment.|||Hours||Full Range|Median
2674959|NCT01451437|Secondary|Maximum Plasma Concentration (Cmax) of MK-8242 Alone and in Combination With Cytarabine|Cmax was determined for Cycle 1 Days 1 and 7 of MK-8226 QD and BID dosing. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (Cmax) at the time of assessment.|||nM||Geometric Coefficient of Variation|Geometric Mean
2674960|NCT01451437|Secondary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for MK-8242 Alone and in Combination With Cytarabine|AUC0-∞ defined as AUC from time zero to infinity was determined for Cycle 1 Day 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. Projection beyond the last sampled time was made if a linear terminal elimination phase half-life was identified with three time-points after Tmax (condition not met for 60 QD and 120 BID dose groups). Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1 Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24, 48 hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (AUC0-∞) at the time of assessment.|||hr*nM||Geometric Coefficient of Variation|Geometric Mean
2674961|NCT01451437|Secondary|Area Under the Concentration-time Curve From Time 0 to Last (AUC0-last) for MK-8242 Alone and in Combination With Cytarabine|AUC(0-last) defined as AUC from time zero to the time of last quantifiable sample was determined for Cycle 1 Days 1 and 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 24, and 48 [Day 7 only] hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], 24 [Day 7 only], 48 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (AUC0-last) at the time of assessment.|||hr*nM||Geometric Coefficient of Variation|Geometric Mean
2674975|NCT01451411|Secondary|Population Pharmacokinetics: Clearance (CL)|Based on conivaptan concentrations, the pharmacokinetics of the study population will be analyzed to determine median CL|Up to Hour 60|Due to the terminated status of the study, pharmacokinetic samples were not analyzed.||||||
2674976|NCT01451411|Secondary|Number of Participants With an Overly Rapid Rise in Serum Sodium From Baseline|an absolute serum sodium of 145 mEq/L at Hour 24 or an increase in serum sodium of greater than 12 mEq/L|baseline and Hours 3, 8, 12 and 24.||||participants|||Number
2674962|NCT01451437|Secondary|Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24hr) for MK-8242 Alone and in Combination With Cytarabine|AUC(0-24hr) defined as AUC from time zero to 24 hours was determined for Cycle 1 Days 1 and 7 of MK-8242 QD and BID dosing using the trapezoidal up/log trapezoidal down method. For the BID arms, a projection beyond the last sampled time was made if a linear terminal elimination phase half-life was identified with three time-points after Tmax. Analysis for the combination therapy was not performed due to early termination of the study (Study Arm B was not performed).|Cycle 1, Day 1 and Day 7 (QD arms: predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, and 24 hrs postdose; BID arms: predose and 0.5, 1, 2, 4, 6, 8, 12 [optional], and 24 [Day 7 only] hrs postdose)|Participants who received at least one dose of MK-8242, were compliant with study procedures, and had available pharmacokinetic data (AUC0-24hr) at the time of assessment.|||hr*nM||Geometric Coefficient of Variation|Geometric Mean
2674963|NCT01451437|Secondary|Number of Participants With CRi at Dose Levels Other Than RP2D|Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CRi according to Cheson (2003) criteria at dose levels other than RP2D. CRi is defined as fulfillment of all CR criteria with exceptions for residual neutropenia (<1,000/µL), thrombocytopenia (<100,000/µL), and RBC transfusion dependence. Presented outcome values are not stratified for dose levels other than RP2D; the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.|End of Treatment (up to 198 days)|Modified Full Analysis Set for Efficacy: all participants with confirmed p53 WT status who received at least one dose of MK-8242.|||Participants|||Number
2674964|NCT01451437|Secondary|Number of Participants With CR at Dose Levels Other Than RP2D|Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CR according to Cheson (2003) criteria at dose levels other than RP2D. CR is defined as a morphologic leukemia-free state with a neutrophil count ≥1,000/µL, a platelet count ≥100,000/µL, no extramedullary disease, and RBC transfusion independence. Presented outcome values are not stratified for dose levels other than RP2D; the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.|End of Treatment (up to 198 days)|Modified Full Analysis Set for Efficacy: all participants with confirmed p53 WT status who received at least one dose of MK-8242.|||Participants|||Number
2674965|NCT01451437|Primary|Number of Participants With Complete Remission With Incomplete Marrow Recovery (CRi) at RP2D|Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CRi according to Cheson (2003) criteria at the RP2D. The outcome analysis was not performed since the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.|End of Treatment (up to 198 days)|Full Analysis Set for Efficacy: all participants with confirmed p53 WT status who received at least one dose of MK-8242 and have at least one baseline and one post-baseline efficacy assessment.||||||
2674966|NCT01451437|Primary|Number of Participants With Complete Remission (CR) at RP2D|Clinical activity of MK-8242 given as monotherapy in participants with refractory or recurrent AML measured as participants who achieved CR according to Cheson (2003) criteria at the RP2D. The outcome analysis was not performed since the RP2D for MK-8242 monotherapy could not be established due to early termination of the study.|End of Treatment (up to 198 days)|Full Analysis Set for Efficacy: all participants with confirmed p53 wild type (WT) status who received at least one dose of MK-8242 and have at least one baseline and one post-baseline efficacy assessment.||||||
2674967|NCT01451437|Primary|Number of Participants With Dose Limiting Toxicities (DLTs)|DLTs were identified using Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0 for toxicities attributable to the study drug. Hematologic DLTs were defined in the absence of morphological evidence of acute leukemia in the marrow if 1) bone marrow: aplastic marrow with <5% cellularity without erythroid, myeloid, or megakaryocytic precursors and 2) peripheral blood: absolute neutrophil count (ANC) <100/µL, platelet count <10,000/µL, and transfusion-dependent anemia. Non-hematologic DLTs were defined as any ≥Grade 3 toxicity with the following exceptions/clarifications: 1) infection, fatigue, anorexia, or alopecia are not included in determination of the DLT 2) Grade 3 nausea, vomiting, diarrhea, or dehydration occurring in a setting of inadequate treatment 3) any abnormal non-hematological laboratory value ≥Grade 3 will be considered a DLT after 72 hours of appropriate medical intervention if not related to an underlying disease or not attributable to another event.|Up to 28 days (Cycle 1) for non-hematologic toxicities and 42 days (Cycle 1) for hematologic toxicities|DLT-evaluable Population: participants who received at least one dose of MK-8242 and completed Cycle 1 of Part 1 or discontinued due to reason of toxicity.|||Participants|||Number
2674968|NCT01451424|Secondary|Change in Quality of Life|Percentage change from baseline in median quality of life using uterine fibroid symptom and quality of life questionnaire (UFSQOL)|12 or 16 weeks|MITT. Note: lower score is improvement|||Percent change||Full Range|Median
2674969|NCT01451424|Secondary|Endometrial Thickness|Percent change in median endometrial thickness from baseline to end of treatment assessed by ultrasound determination of uterine stripe.|12 or 16 weeks|Safety population, data based on subjects with both baseline and end of treatment assessments|||Percent change||Full Range|Median
2674970|NCT01451424|Secondary|Induction of Amenorrhea at End of Treatment|"Percentage of subjects with induced amenorrhea during last 28 days on drug~Amenorrhea was deemed to be achieved if no daily bleeding score was greater than 1 during the last 28 calendar days of the dosing period. A score of 1 was to be indicated if spotting was observed which did not require a sanitary product. Subjects that terminated early were deemed not to have achieved amenorrhea."|End of treatment||||Percentage of particpants|||Number
2674971|NCT01451424|Secondary|Uterine Fibroid Size|Percent change in volume of confirmed uterine fibroids at end of treatment, assessed by MRI|12 or 16 weeks|MITT population|||Percentage change||Full Range|Median
2674972|NCT01451424|Secondary|Blood Levels of Proellex|Determination of Cmax of Proellex at end of treatment|12 or 16 weeks|Subjects with end of treatment PK assessment|||ng/dL||Standard Deviation|Mean
2674973|NCT01451424|Primary|Change From Baseline in Vaginal Bleeding|"Change from baseline in vaginal bleeding assessed at the end of treatment (12 or 16 weeks) using a Pictorial Blood Loss Assessment Chart (PBAC), which measures volume (mL) of blood loss over a 28-day period~Less blood loss represents an improvement."|12 or 16 weeks|MITT population|||mL||Full Range|Median
2674984|NCT01451398|Secondary|Mean 7-point Glucose Week 24 Values|Mean 7-point self-monitored blood glucose at Week 24|Week 24|Full analysis set for patients with data at Week 24|||mg/dL||Standard Deviation|Mean
2674998|NCT01451372|Primary|Daily Usage of Blood Glucose Test (BG Testing)|Daily usage of blood glucose test 0-24 months after CGM usage. This information is collected in a journal questionnaire|24 months|journal questionnaires about blood glucose testing were collected from 65 out of 69 subjects|||number of blood glucose test per day||Standard Deviation|Mean
2674999|NCT01451203|Secondary|Percentage of Participants Meeting the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean-based Remission Criteria at Weeks 24 and 52|"The ACR/EULAR Boolean-based remission rate measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count (TJC);~28 swollen joint count (SJC);~Patient's global assessment of disease activity (PtGADA);~C-reactive protein (CRP)~To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.~A participant was considered to be in remission if all the criteria for each variable was met:TJC (in 28 joints) ≤1; SJC (in 28 joints) ≤1; CRP ≤1 mg/dl; PtGADA ≤1.~Last Observation Carried Forward (LOCF) was applied"|Week 24 and Week 52|FAS|||percentage of participants||95% Confidence Interval|Number
2675000|NCT01451203|Secondary|Clinical Remission Rate: Percentage of Participants Meeting the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Simplified Disease Activity Index (SDAI)-Based Remission Criteria at Weeks 24 and 52|"The ACR/EULAR SDAI remission rate measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count (TJC);~28 swollen joint count (SJC);~Patient's global assessment of disease activity (PtGADA);~Physician's Global Assessment of Disease Activity (PhGADA);~C-reactive protein (CRP)~To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.~A participant was considered to be in remission if SDAI ≤3.3.~Last Observation Carried Forward (LOCF) was applied."|Week 24 and Week 52|FAS|||percentage of participants||95% Confidence Interval|Number
2675001|NCT01451203|Secondary|Clinical Remission Rate: Percentage of Participants Meeting the Disease Activity Score-28 Joint Count (DAS28) Erythrocyte Sedimentation Rate (ESR) (DAS28[ESR]) Remission Criteria at Weeks 24 and 52|"The DAS28(ESR) measures the severity of disease at a specific time and is derived from the following variables:~28 tender joint count (TJC);~28 swollen joint count (SJC);~ESR;~Patient's global assessment of disease activity (PtGADA).~To obtain the tender joint count and swollen joint count, 28 joints of the shoulder, elbow, wrist, metacarpophalangeal joints, thumb interphalangeal joints, proximal interphalangeal joints, and knee joints were examined.~DAS28(ESR) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible ESR. A participant was considered to be in remission if DAS28(ESR) <2.6.~Last Observation Carried Forward (LOCF) was applied."|Week 24 and Week 52|FAS|||percentage of participants||95% Confidence Interval|Number
2675002|NCT01451203|Secondary|Change From Baseline in mTSS at Week 24|"Radiographs/X-rays of hands and feet (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by two radiographic readers. The degree of joint damage was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.~The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst)."|Baseline and Week 24|FAS with available data.|||units on a scale||Standard Deviation|Mean
2675003|NCT01451203|Primary|Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52|"Radiographs/X-rays of hands and feet (posteroanterior views of both hands and dorsoplantar views of both feet) were independently assessed by two radiographic readers. The degree of joint damage was graded by assessing bone erosion in 44 joints and joint space narrowing (JSN) in 42 joints.~The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (complete collapse of bone). The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The mTSS ranges from 0 (normal) to 448 (worst)."|Baseline and Week 52|FAS with available data.|||units on a scale||Standard Deviation|Mean
2675004|NCT01451164|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.|The efficacy of trial medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at Baseline prior to the first dose of double-blind study medication. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation.|||units on a scale||Standard Deviation|Mean
2675005|NCT01451164|Secondary|Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity of Illness (CGI-S)|"Severity of illness for each participant was rated using the CGI-S, which was the secondary efficacy endpoint. To perform this assessment, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation.|||units on a scale||Standard Error|Least Squares Mean
2675006|NCT01451164|Secondary|Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|EEfficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation.|||units on a scale||Standard Error|Least Squares Mean
2675007|NCT01451164|Secondary|Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.|PANSS consisted of three subscales: a total of 30 symptom constructs. For each construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation.|||units on a scale||Standard Error|Least Squares Mean
2675008|NCT01451164|Primary|Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample（FAS : Full Analysis Set） consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline PANSS total score evaluation.|||units on a scale||Standard Error|Least Squares Mean
2675009|NCT01450943|Secondary|Cost Effectiveness||12 weeks|Data not available because the investigators did not asses the cost effectiveness for the study.||||||
2675010|NCT01450943|Secondary|Wound Closure at 20 Weeks|Complete wound closure at study endpoint. The Secondary outcome of interest is defined as the wound healed completely on or before visit 19, regardless of a later recurrence. The number of subjects analyzed at secondary outcome differs from primary outcome due to some subjects not completing the study.|20 weeks|Primary Outcome results consist of data still available for the Veteran patient population participants who completed the study.|||Wound Closure in weeks|||Number
2675011|NCT01450943|Primary|Wound Closure by Week 15|The primary outcome of interest is defined as the wound healed completely on or before visit 15, regardless of a later recurrence.|15 weeks|Primary Outcome results consist of data available for the Northern California Veteran patient population participants who completed the study.|||Participants|||Count of Participants
2675012|NCT01450826|Secondary|Time to Treatment Failure|Median time in days to first emetic episode or first need of rescue medication, whichever occurred first as measured by the MAT/Osoba survey, among those patients experiencing an emetic episode or need of rescue medication|7 days|This analysis only includes those patients no achieving complete control (no emetic episode or need for rescue medication throughout the 7-day study period).|||days||Full Range|Median
2675013|NCT01450826|Secondary|Patient's Global Satisfaction With the Antiemetic Regimen|"Patients' global satisfaction with the antiemetic regimen is measured using the Osoba survey, which was administered on days 1-7. This survey asks patients In the past 24 hours, did vomiting or dry heaves a) interfere with your appetite, b) affect your sleep, c) interfere with your physical activities, d) interfere with your social life, and e) interfere with your enjoyment of life? Patients responded on a scale of 1-4 ranging from 'Not at all' to 'Very much.' Global satisfaction was defined as responding 'Not at all' for all questions related to vomiting/retching for each study day. The proportion of patients responding 'Not at all' for all Osoba vomiting/retching questions over the study period is reported."|7 days|2 patients in the Aprepitant + Ondansetron arm and 4 patients in the Ondansetron arm did not have adequate survey data for this analysis|||proportion of patients|||Number
2675014|NCT01450826|Secondary|Proportion of Patients Achieving an Acute and Delayed Complete Response (CR)|CR is the proportion of patients with no emetic episode and no rescue medication. (1) Assessed from the beginning of study day 1, CR is defined for acute CINV as no emetic episode and no use of rescue anti-nausea medication during the first 24 hours following chemotherapy administration. An emetic episode is defined as one episode of vomiting or a sequence of episodes in very close succession not relieved by a period of relaxation of at least 1 min, any number of unproductive emetic episodes (retches) in any given 5 minute period, or an episode of retching lasting <5 minutes combined with vomiting not relieved by a period of relaxation of at least 1 minute; (2) Complete response (CR) on study days 2-7 (delayed CINV) is defined as the proportion of patients achieving a CR during the delayed time period. The data will be captured by the validated ultinational Association of Supportive Care in Cancer (MASCC) Anti-emesis Tool (MAT)/Osoba survey.|7 days|Intent to treat|||proportion of patients|||Number
2675015|NCT01450826|Primary|Proportion of Patients Achieving Complete Control (CC)|Complete control (CC): study days 1-7 (acute and delayed CINV) the proportion of patients achieving complete control (CC); defined as no emetic episode, no need for rescue medication during days 1-7; number of emetic episodes daily; time to first emetic episode; as captured by the MAT (MASCC Antiemesis Tool)/Osoba survey (MASCC refers to Multinational Association for Supportive Care in Cancer™). Severity of nausea and other toxicities measured daily by the NCI Common Toxicity Criteria (version 4.0).|7 days|Intent to treat|||proportion of patients|||Number
2675016|NCT01450813|Secondary|The Average CVI During the Maintenance Phase of Anesthesia for the Two Remifentanil Groups|Mean CVI from incision to propofol off reported as the mean CVI +/- 95% confidence interval for the two groups|Maintenance Anesthesia||||units on a scale||95% Confidence Interval|Mean
2675017|NCT01450813|Primary|The Mean Difference in CVI Between Pre-laryngoscopy and Post-laryngoscopy for Each of the Four Rocuronium Groups|"The difference between the mean CVI in three minutes prior to laryngoscopy and three minutes following laryngoscopy reported as the mean change in CVI and the +/- 95% confidence interval for each group.~The Composite Variability Index (CVI) scale is a logistic regression of three measures of processed electroencephalography (EEG) signals. These signals are Bispectral Index (BIS), the variability of electromyelogram (sEMG), and the variability of BIS (sBIS). The scale ranges from 0 to 100 where a lower CVI value represents a lower likelihood of intraoperative somatic responses, and a higher CVI value represents a higher likelihood of intraoperative somatic responses."|Six minutes after the dose of rocuronium with laryngoscopy at 3 minutes after the study intervention||||units on a scale||95% Confidence Interval|Mean
2675018|NCT01450800|Other Pre-specified|Antibiotic Resistance to Macrobid|We examined for macrobid resistance on urine culture results within 3 weeks of surgery|6 weeks after surgery|Examined urine cultures with susceptibility testing results for all participants who had positive urine culture results|||urine culture resistant to nitrofurantoi|||Number
2675019|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to postoperative catheter type|3 weeks following surgery|Used entire study population to determine risk factors for UTI|||participants|||Number
2675020|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to total postoperative catheter days|3 weeks following surgery|Used entire study population to determine risk factors for UTI|||days of catheterization||95% Confidence Interval|Median
2675021|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to sling as part of surgery|3 weeks following surgery|Used entire study population to determine risk factors for UTI|||participants|||Number
2675022|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to Creatinine Clearance|3 weeks following surgery|Used entire study population to determine risk factors for UTI|||mL/min||Standard Deviation|Mean
2675023|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to preoperative UTI treatment|3 weeks following surgery|Used entire study population to determine risk factors for UTI|||participants|||Number
2675024|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to history of recurrent UTIs|3 weeks following surgery|Used entire study population to determine risk factors for UTI|||participants|||Number
2675025|NCT01450800|Secondary|Other Risk Factors for UTI|We examined risk of UTI as related to vaginal estrogen therapy|3 weeks following surgery|Used entire study population to determine risk factors for UTI|||participants|||Number
2675026|NCT01450800|Primary|Urinary Tract Infections|The primary outcome was treatment for UTI within the first 3 weeks after surgery. Treatment for UTI was defined to include any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery. Clinically suspected treatment was defined to include treatment given empirically upon development of urinary symptoms or prescribed based on urine test results. Culture-proven UTI was defined as a urine culture with greater than 100,000 colony-forming units of a single organism.|three weeks post-operative|Intent-to-treat analysis|||participants|||Number
2675027|NCT01450787|Other Pre-specified|Corneal Staining|Corneal staining with fluorescein solution is graded at the time of the exam on a scale of 0 to 5 using the oxford scoring system with 5 being the most severe staining.|at the time of the exam|All patients underwent corneal staining evaluations using fluorescein.|||units on a scale|Participants|Standard Error|Mean
2675028|NCT01450787|Other Pre-specified|Tear Break-up Time|The tear break-up time with fluorescein solution is measured at the time of the exam in seconds.|at the time of the exam|Each patient underwent tear break-up time testing|||seconds|Participants|Standard Error|Mean
2675029|NCT01450787|Other Pre-specified|Schirmer Score|The schirmer tear production test with anesthesia is completed at the time of the exam in mm of tear film absorption on the test strip after five minutes. Higher scores represent greater tear production.|at the time of the exam|Each patient underwent schirmer testing|||mm|Participants|Standard Error|Mean
2675030|NCT01450787|Other Pre-specified|OSDI Score|The ocular surface disease index survey in completed at the time of the exam. This scale ranges from 0 to 100 higher scores representing greater disability.|at the time of the exam|All patients completed the OSDI survey|||units on a scale||Standard Error|Mean
2675031|NCT01450787|Secondary|Tear Film Osmolarity|The tear film osmolarity is measured at the time of the exam.|at the time of the exam|Tear film osmolarity was measured in all patients, but two patients in the diabetic group had an insufficient tear film to obtain a reading. Therefore, only 36 diabetics were included.|||mOsml/L|Participants|Standard Error|Mean
2675032|NCT01450787|Primary|Conjunctival Staining Score|Conjunctival staining with lissamine green dye is measured at the time of the evaluation on a scale from 0 to 5 using the oxford scoring system, with 5 being the most severe staining.|at the time of the evaluation|There were 38 consecutive diabetics over 40 years of age and 25 consecutive non-diabetics over 40 years of age that qualified and agreed to enroll. A target of 25 non-diabetics was met. The target of 50 was not met as the study was stopped when the PI changed practices. By that time, 38 diabetics enrolled.|||units on a scale|Participants|Standard Error|Mean
2675033|NCT01450761|Secondary|Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy|Progression-Free Survival was defined as the time from the date of randomization to the date of progression per modified World Health Organization (mWHO) criteria or death, whichever occured first. A participant who died without reported progression per mWHO criteria was considered progressed on the date of death. For those participants who remained alive and did not progress, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.|From randomization until disease progression, up to March 2015, approximately 38 months|All randomized participants who received at least one dose of blinded study therapy|||months||95% Confidence Interval|Median
2675034|NCT01450761|Secondary|Overall Survival in All Randomized Participants|Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.|From randomization until date of death, up to March 2015, approximately 38 months|All randomized participants|||months||95% Confidence Interval|Median
2675035|NCT01450761|Primary|Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy|Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.|Randomization until date of death, up to March 2015, approximately 38 months|All randomized participants who received at least one dose of blinded study therapy|||months||95% Confidence Interval|Median
2675036|NCT01450696|Secondary|Trastuzumab Serum Concentration on Day 1 of Cycle 1 - FAS|Trastuzumab serum concentration samples were obtained in all participants randomized to receive Herceptin (FAS). The observed concentration values were recorded, averaged among all participants, and expressed in μg/mL.|Pre-dose (0 minutes) and within 15 minutes after end of 2-hour Herceptin infusion on Day 1 of Cycle 1 (cycle length = 21 days)|"FAS population. Here, number of participants analyzed reflects the number of participants who were evaluable for this outcome measure. Here also, n reflects the number of participants who were evaluable for each category in the respective arms."|||μg/mL||Standard Deviation|Mean
2675037|NCT01450696|Secondary|Trastuzumab Cmin on Day 21 of Cycles 1 to 11 - FAS|Cmin samples were obtained in all participants randomized to receive Herceptin (FAS). The observed Cmin was recorded, averaged among all participants, and expressed in μg/mL.|Day 21 of Cycle 1, 2, 3, 4, 5, 7, 9, 11 (cycle length = 21 days)|FAS population. Here, number of participants analyzed reflects the number of participants who were evaluable for this outcome measure. Here also, “n” reflects the number of participants who were evaluable for each category in the respective arms.|||μg/mL||Standard Deviation|Mean
2675038|NCT01450696|Secondary|Percentage of Participants With Objective Response - PPS|Objective response was defined as the occurrence of either a complete response (CR) or partial response (PR) as determined by RECIST Version 1.1 based on investigator assessment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) were required to have reduction in short axis to <10 mm. PR was defined as a ≥30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters. The 95% CI was constructed using Blyth-Still-Casella method.|From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)|PPS population.|||percentage of participants||95% Confidence Interval|Number
2675039|NCT01450696|Secondary|Progression-Free Survival - PPS|Progression-free survival was defined as the time between the day of randomization and the date of first documentation of disease progression or date of death, whichever occurred first, measured following RECIST Version 1.1 criteria. Disease progression was defined as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline (nadir). In addition to the relative increase of 20%, the sum was also required to demonstrate an absolute increase of ≥5 mm. The 95% CI for median was computed using the method of Brookmeyer and Crowley.|From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)|PPS population.|||months||95% Confidence Interval|Median
2675040|NCT01450696|Secondary|Percentage of Participants With Disease Progression or Death - PPS|Disease progression was defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including Baseline (nadir). In addition to the relative increase of 20%, the sum was also required to demonstrate an absolute increase of ≥5 millimeters (mm). The percentage of participants who died or experienced disease progression as of the analysis data cutoff date of 13 February 2015 was reported among participants from the PPS.|From date of randomization until first occurrence of disease progression or death; assessed every 6 weeks (up to approximately 31 months or data cutoff date of 13 February 2015)|PPS population.|||percentage of participants|||Number
2675041|NCT01450696|Secondary|Overall Survival - PPS|Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival was estimated among participants from the PPS using the Kaplan-Meier approach. The 95% CI for median was computed using the method of Brookmeyer and Crowley.|From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)|PPS population.|||months||95% Confidence Interval|Median
2675042|NCT01450696|Secondary|Percentage of Participants Who Died - Per Protocol Set (PPS)|The percentage of participants who died as of the analysis data cutoff date of 13 February 2015 was reported among participants from the PPS.|From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)|The PPS included all participants who were found to have a trastuzumab minimum plasma concentration (Cmin) less than (<) 12 micrograms per milliliter (μg/mL) on treatment Day 21 of Cycle 1 following the initial loading dose of 8 mg/kg.|||percentage of participants|||Number
2675043|NCT01450696|Primary|Overall Survival - FAS|Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival was estimated among participants from the FAS using the Kaplan-Meier approach. The 95 percent (%) confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.|From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)|FAS population. Here, number of participants analyzed reflects the number of participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2675044|NCT01450696|Primary|Percentage of Participants Who Died - FAS|The percentage of participants who died as of the analysis data cutoff date of 13 February 2015 was reported among participants from the FAS with available data.|From date of randomization until death or premature withdrawal (up to approximately 31 months or data cutoff date of 13 February 2015)|FAS population. Here, number of participants analyzed reflects the number of participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2675045|NCT01450683|Primary|Reduction in Serum PSA|Number of subjects with > 50% drop in serum PSA as compared to baseline, at 12 weeks and confirmed at 15 weeks|12 weeks treatment, with primary outcome assessed at 15 weeks||||participants|||Number
2675056|NCT01450319|Primary|Overall Survival (OS) Time|Overall survival was defined as the time from date of informed consent signature until death.|From the date of informed consent signature until death, assessed up to 3 years|MITT analysis set included all the subjects who received study drug treatment.|||Months||95% Confidence Interval|Median
2675046|NCT01450631|Secondary|Incidence Rate of Surgical Incision Intervention (SII) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.|"Incidence rate of surgical incision intervention (SII) post Cesarean section surgery. Interventions include:~Antimicrobials for surgical site infection~Surgical drainage of the incision~Surgical incision packing~Adjunctive negative pressure therapy~Debridement~Re-operation"|Post-op Day: 42 (+/- 10 days) after Cesarean section surgery|The Per-protocol Population was used for primary and secondary endpoint analysis.|||participants|||Number
2675047|NCT01450631|Primary|Incidence of Postoperative Surgical Site Occurrences (SSOs) up to Day 42 (+/- 10 Days) Post Cesarean Section Surgery.|"Incidence of postoperative surgical site occurrences (SSOs) post Cesarean section surgery. SSOs include:~Unanticipated local inflammatory response~Prolonged drainage~Fluid collection~Dehiscence~Surgical site infection (SSI)"|Post-op Day 42 (+/- 10 days) after Cesarean section surgery|The Per-protocol Population was used for primary and secondary endpoint analysis.|||participants|||Number
2675048|NCT01450397|Primary|The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation.|Change in Volume (millimeter cubed) of the Cord by MRI between Baseline and 30 days after XIAFLEX injection and manual manipulation.|Baseline and 30 days||||mm^3||Full Range|Mean
2675049|NCT01450319|Secondary|Beta 2-microglobulin||Baseline, Week 8|"MITT analysis set included all the subjects who received study drug treatment. Here n signifies number of evaluable subjects for each category, as specified."|||microgram per milliliter (mcg/mL)||Standard Deviation|Mean
2675050|NCT01450319|Secondary|Overall Survival (OS) Related to Killer Inhibitory Receptors 2DS4 (KIR2DS4) Functional Receptor (f/d) and Non-functional Receptor (NFR)|OS was defined as the time from informed consent signature until death. Subjects without death were censored at the last date known alive (within the study).|From the date of informed consent signature until death, lost-to-follow-up or end of study, whatever occurred first (maximal assessed up to 3 years)|"MITT analysis set included all the subjects who received study drug treatment. Here Number of subjects analyzed signifies number of evaluable subjects for this outcome measure."|||months||95% Confidence Interval|Median
2675051|NCT01450319|Secondary|Overall Survival (OS) Related to Codon G13D|OS was defined as the time from informed consent signature until death. Subjects without death were censored at the last date known alive (within the study).|From the date of informed consent signature until death, lost-to-follow-up or end of study, whatever occurred first (maximal up to 3 years)|"MITT analysis set included all the subjects who received study drug treatment. Here Number of subjects analyzed signifies total number of evaluable subjects for this outcome measure; “n” signifies number of evaluable subjects for each category, as specified."|||months||95% Confidence Interval|Median
2675052|NCT01450319|Secondary|Number of Subjects With Fcγ Receptors (FCγR) IIa/IIIa Polymorphisms|The antibody fragment C portion (FCy) of cetuximab interacts with Fc-gamma receptors (FCyRs) expressed by immune effector cells. Polymorphisms were described in genes coding for FCyRIIa and in FCyRIIIa. A histidine/arginine polymorphism at position 131 for FCyRIIa gene and valine ⁄ phenylalanine polymorphism at position 158 for the FCyRIIIa gene were reported to be functionally relevant in the ADCC mechanism. All subjects were analyzed and classified as carriers of every different polymorphism of FCy Receptors: for FCyRIIa (H/H, homozygous alleles with histidine and R/H, heterozygous alleles with arginine/histidine) and FCyRIIIa (V/V, homozygous alleles with valine, F/F, homozygous alleles with phenylalanine and F/V, heterozygous alleles with valine ⁄ phenylalanine) (units: subjects with every type of polymorphism) .The FCyR genotype was determined using a TaqMan Allelic Discrimination Assay.|Baseline|MITT analysis set included all the subjects who received study drug treatment. Subjects may fall into more than one category.|||Subjects|||Number
2675053|NCT01450319|Secondary|Number of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, AEs Leading to Death|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the date of enrollment up to 30 days after the last dose of study drug administration, assessed up to 3 years|Safety analysis set included all the subjects who received at least one dose of the study drug treatment.|||Subjects|||Number
2675054|NCT01450319|Secondary|Progression Free Survival (PFS) Time|PFS was defined as the time from informed consent signature until PD or death, whatever occurred first. Subjects who did not have disease progression or were lost to follow-up, were censored at the date of last contact, known to be alive and progression free; moreover, those subjects who started a new treatment (different from cetuximab), were censored at the date of starting the new treatment. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.|From the date of informed consent signature until progressive disease (PD) or death, assessed up to 3 years|MITT analysis set included all the subjects who received study drug treatment.|||Months||95% Confidence Interval|Median
2675055|NCT01450319|Secondary|Percentage of Subjects With Disease Control Rate (DCR)|DCR was defined as those subjects achieving complete response (CR), partial response (PR) or stable disease (SD), according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1). For target lesions (TLs), CR was defined as the disappearance of all TLs; PR was defined as at least a 30 percent (%) decrease in the sum of longest diameter (SLD) of the TLs, taking as a reference the baseline (BL) SLD; Stable disease (SD) was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For non-target lesions (NTLs), CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and progressive disease (PD) was defined as the appearance|From the date of informed consent signature until progressive disease, assessed up to 3 years|MITT analysis set included all the subjects who received study drug treatment.|||Percentage of subjects|||Number
2675057|NCT01450306|Secondary|Clinician's Global Impression (CGI)-Improvement|"Clinician rating of global illness severity (at post-treatment)~CGI-Improvement range 1-7; higher scores indicate poorer improvement; classified as responder if score = 1 or 2, nonresponder if score > 2"|2 weeks||||participants|||Number
2675058|NCT01450306|Secondary|Clinician's Global Impression (CGI)-Severity|"Clinician rating of global illness severity (at pre- and post-treatment)~CGI-Severity range 1-7; higher scores indicate greater illness severity."|2 weeks||||units on a scale||Standard Deviation|Mean
2675059|NCT01450306|Primary|Snake Questionnaire (SNAQ)|"30-item self-report scale of severity of snake fear and avoidance~Range: 0-30; higher values indicate greater fear severity"|2 weeks||||units on a scale||Standard Deviation|Mean
2675060|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 52, Men|median HIV RNA concentration as measured in semen|52 weeks|Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.|||copies/ml||Full Range|Median
2675061|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 26, Men|median HIV RNA concentration as measured in semen|26 weeks|Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.|||copies/ml||Full Range|Median
2675062|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 12, Men|median HIV RNA concentration as measured in semen|12 weeks|Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit.|||copies/ml||Full Range|Median
2675063|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 52, Women|median HIV RNA concentration in cervical lavage fluid|52 weeks|Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.|||copies/ml||Full Range|Median
2675064|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 26, Women|median HIV RNA concentration in cervical lavage fluid|26 weeks|Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.|||copies/ml||Full Range|Median
2675065|NCT01450189|Secondary|Genital HIV RNA Concentration - Week 12, Women|median HIV RNA concentration in cervical lavage fluid|12 weeks|Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit.|||copies/ml||Full Range|Median
2675066|NCT01450189|Secondary|Blood HIV RNA Concentration at Week 52||52 weeks|Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.|||copies/ml||Full Range|Median
2675067|NCT01450189|Secondary|Blood HIV RNA Concentration at Week 26||26 weeks|Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.|||copies/ml||Full Range|Median
2675068|NCT01450189|Secondary|Blood HIV RNA Concentration at Week 12||12 weeks|Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit.|||copies/ml||Full Range|Median
2675069|NCT01450189|Secondary|Time to HIV RNA Suppression <1000 c/ml|median time to viral load suppression (<1000 c/ml)|From date of randomization until viral load suppression, up to 52 weeks||||weeks||95% Confidence Interval|Median
2675070|NCT01450189|Secondary|Suppression of HIV RNA to <1000c/ml at 12 Weeks|Proportion of persons in each arm with viral load <1000copies/ml at 12 weeks|12 weeks||||Proportion of participants||95% Confidence Interval|Number
2675071|NCT01450189|Secondary|Proportion of Partners Reporting for HIV Testing|Proportion of sexual partners reporting for HIV testing among all sexual partners named by the index participants|52 weeks|The number of sexual partners named by the index participants is the denominator. For example, the 9 index participants in the standard arm named 35 partners. 4 partners presented, giving a proportion of 0.1 (4/35)|||proportion of sex partners|sexual partners|95% Confidence Interval|Number
2675072|NCT01450189|Secondary|Number of Partners Reporting for HIV Testing|Number of partners per index reporting for HIV testing at any time during follow-up|52 weeks||||partners per index participant||95% Confidence Interval|Mean
2675073|NCT01450189|Secondary|Cumulative Incidence Herpes Simplex Virus Type 2|cumulative incidence of herpes simplex virus type 2, assessed at 52 weeks. Persons with baseline positivity were excluded.|52 weeks|Number includes all persons who were confirmed HSV-2 negative at baseline and who had an informative test on or before Week 52|||Proportion of participants||95% Confidence Interval|Number
2675074|NCT01450189|Secondary|Cumulative Incidence Herpes Simplex Virus Type 2|cumulative incidence of herpes simplex virus type 2, assessed at 26 weeks. Persons with baseline positivity were excluded.|26 weeks|Number includes all persons who were confirmed HSV-2 negative at baseline and who had an informative test on or before Week 26|||Proportion of participants||95% Confidence Interval|Number
2675075|NCT01450189|Secondary|Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)|At least one incident infection with either gonorrhea, chlamydia or trichomoniasis|52 weeks|Number includes all persons with gonorrhea, chlamydia, and trichomoniasis results and who had at least one visit after Week 26|||proportion of participants||95% Confidence Interval|Number
2675076|NCT01450189|Secondary|Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)|Cumulative incidence, definied as at least one incident infection with either gonorrhea, chlamydia or trichomoniasis|26 weeks|Number includes all persons with gonorrhea, chlamydia, and trichomoniasis results who had not withdrawn from the study by the first scheduled STI tests|||proportion of participants||95% Confidence Interval|Number
2675077|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Month - 52 Weeks|The mean number of unprotected sex acts in previous one month, assessed at 52 weeks|52 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit|||unprotected sex acts/month||95% Confidence Interval|Mean
2675078|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Month - 26 Weeks|The mean number of unprotected sex acts in previous one month, assessed at 26 weeks|26 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit|||unprotected sex acts/month||95% Confidence Interval|Mean
2675079|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Month - 12 Weeks|The mean number of unprotected sex acts in previous one month, assessed at 12 weeks|12 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit|||unprotected sex acts/month||95% Confidence Interval|Mean
2675080|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Week - 52 Weeks|The mean number of unprotected sex acts in previous one week, assessed at 52 weeks|52 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit|||unprotected sex acts/week||95% Confidence Interval|Mean
2675081|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Week - 26 Weeks|The mean number of unprotected sex acts in previous one week, assessed at 26 weeks|26 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit|||unprotected sex acts/week||95% Confidence Interval|Mean
2675082|NCT01450189|Secondary|Unprotected Sex Acts in Previous One Week - 12 Weeks|The mean number of unprotected sex acts in previous one week, assessed at 12 weeks|12 weeks|Number includes enrolled persons who completed the ACASI interview within the window for this visit|||unprotected sex acts/week||95% Confidence Interval|Mean
2675083|NCT01450189|Primary|Number of Adverse Events|Mean number of adverse events per group|one year||||number of events||95% Confidence Interval|Mean
2675084|NCT01450189|Primary|Proportion of Persons Completing All Scheduled Visits in Each Study Arm||1 year||||Proportion of participants||95% Confidence Interval|Number
2675085|NCT01450189|Primary|Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment.|In this pilot study, we addressed our ability to complete the behavioral intervention quickly. As two arms received the behavioral intervention, this outcome is combined across those two arms.|1 year|All persons in the two behavioral intervention arms|||proportion of participants||95% Confidence Interval|Number
2675086|NCT01450189|Primary|Proportion of Participants Completing Full Course of ARVs in Arm BIA|Proportion of participants in the BIA arm receiving full course of ARVs. This outcome is calculated among the BIA arm only, as that|1 year|Number of persons in BIA arm eligible for study-provided ARVs|||proportion of BIA participants||95% Confidence Interval|Number
2675087|NCT01450189|Primary|Proportion of Persons With AHI Successfully Recruited Into the Study|This outcome reflects the ability to recruit persons with AHI into a study. The outcome is based on the population prior to randomization.|1 year||||Proportion of persons with AHI recruited||95% Confidence Interval|Number
2675088|NCT01450189|Primary|Prevalence of AHI Among Persons Screened|Prevalence of AHI among all persons screened. This measure is among all persons screened, prior to randomization.|1 year||||proportion of participants||95% Confidence Interval|Number
2675089|NCT01450189|Primary|Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening||1 year|All persons screened|||proportion of participants screened||95% Confidence Interval|Number
2675090|NCT01450137|Secondary|Restricted Mean Survival Time to First Relapse After Induction of Remission||12 months|All randomized patients, intention-to-treat|||Weeks||95% Confidence Interval|Mean
2675091|NCT01450137|Secondary|Cumulative Dose of GCs in mg/kg|cumulative weight-adapted prednisolone dose|12 months|All randomized patients, intention-to-treat|||mg/kg||Inter-Quartile Range|Median
2675092|NCT01450137|Secondary|Number of Relapse Free Patients||12 months|All randomized patients, intention-to-treat|||Participants|||Count of Participants
2675093|NCT01450137|Primary|Number of Patients That Have Achieved Complete Remission of Disease||12 weeks|All randomized patients, intention-to-treat|||Participants|||Count of Participants
2675094|NCT01450098|Secondary|Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs|Data presented are the number of participants who experienced one or more drug-related AEs or any serious AEs. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Baseline through completion of study (approximately 2 months)|All participants who received at least 1 dose of study drug|||participants|||Number
2675095|NCT01450098|Primary|Pharmacokinetics: Peak Plasma Concentration (Cmax) of LY2484595||Predose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 168 hours postdose|All participants in Cohort A who received at least 1 dose of study drug with evaluable LY2484595 maximum observed plasma concentration data|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2675096|NCT01450098|Primary|Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY2484595|Area under the concentration-time curve from time zero to infinity is presented.|Predose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 168 hours postdose|All participants in Cohort A who received at least 1 dose of study drug with evaluable LY2484595 plasma concentration data|||hours times nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2675097|NCT01450007|Secondary|Patient Satisfaction With Pain Control|Pain was rated on a visual analogue scale with 0 = no pain, 3=mild pain, 5=moderate pain, 7=moderate to severe pain, and 10=severe pain.|24 hours, 48 hours, 1 week|Patients analyzed for each category varied see explanations per row (time point): (n=dexamethasone block, dexamethasone IV, placebo).|||units on a scale||Standard Deviation|Mean
2675098|NCT01450007|Secondary|Time Until First Dose of Analgesic||Approximately 10 hours after surgery|The number of participants analyzed is different from the number of participants in each arm who completed the trial because data were not available for 1 participant in the Dexamethasone IV group and 1 participant in the placebo group.|||hours||Standard Deviation|Mean
2675099|NCT01450007|Secondary|Post Operative Opioid Dose at 24 Hours||approximately 24 hours after surgery|The number of participants analyzed is different from the number of participants in each arm who completed the trial because data were not available for 1 participant in the Dexamethasone IV group and 1 participant in the placebo group.|||mg morphine equivalents||Standard Deviation|Mean
2675100|NCT01450007|Primary|Duration of Sensory Blockade|Duration from time of block until complete resolution of sensory blockade in the shoulder is recorded in minutes by patient report.|Within 48 hours|Patients will be included in the primary analysis on the basis of intention to treat.|||hours||Standard Deviation|Mean
2675101|NCT01449955|Secondary|Quick Inventory of Depressive Symptomatology (QIDS)|The QIDS is a 16-item self-report measure that assesses how much a participant endorses each of the DSM-IV-TR symptoms of depression, with each item scored from 0 (no endorsement of symptom) to 3 (endorsement of severe symptomatology). Scores on the QIDS range from 0-27, with higher scores indicating higher depressive symptom severity.|change in QIDS score from baseline to 3 months posttreatment||||units on a scale||Standard Deviation|Mean
2675102|NCT01449955|Secondary|Quick Inventory of Depressive Symptomatology (QIDS)|The QIDS is a 16-item self-report measure that assesses how much a participant endorses each of the DSM-IV-TR symptoms of depression, with each item scored from 0 (no endorsement of symptom) to 3 (endorsement of severe symptomatology). Scores on the QIDS range from 0-27, with higher scores indicating higher depressive symptom severity.|change in QIDS score from baseline to 1 month posttreatment||||units on a scale||Standard Deviation|Mean
2675103|NCT01449955|Secondary|PTSD Checklist (PCL)|Self-report instrument which assesses the intensity of Posttraumatic Stress Disorder symptoms. The PCL measures the 17 DSM-IV PTSD criteria in 17 items. For each item the participant can respond with a rating of 1-5 (with 1 indicating not at all bothered 5 indicating extremely bothered by the symptom) The range of total scores on the PCL is from 17-85, with a greater score indicating greater PTSD symptom severity. The total score is computed by summing the aforementioned 17 items.|change in PCL score from baseline to 3 months posttreatment||||units on a scale||Standard Deviation|Mean
2675104|NCT01449955|Secondary|PTSD Checklist (PCL)|Self-report instrument which assesses the intensity of Posttraumatic Stress Disorder symptoms. The PCL measures the 17 DSM-IV PTSD criteria in 17 items. For each item the participant can respond with a rating of 1-5 (with 1 indicating not at all bothered 5 indicating extremely bothered by the symptom) The range of total scores on the PCL is from 17-85, with a greater score indicating greater PTSD symptom severity. The total score is computed by summing the aforementioned 17 items.|change in PCL score from baseline to 1 month posttreatment||||units on a scale||Standard Deviation|Mean
2675105|NCT01449955|Primary|Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)|The CAPS is administered to assess the frequency and intensity of PTSD symptoms at baseline, and then again 3 months posttreatment. The CAPS is a 25 item semi-structured interview that assesses the 17 DSM-IV PTSD criteria as well as social and occupational impairment. For each item the participant can respond with a rating of 0-8 (with 0 indicating no symptom severity and frequency and 8 indicating extreme symptom severity and frequency). The range of total scores on a CAPS is from 0-136, with a greater score indicating greater PTSD symptom severity. The total score is computed by summing the aforementioned 17 items. Additionally, the CAPS assesses for a positive PTSD diagnosis by assessing for the three DSM-IV criteria of B, C, and D. In order to meet a positive screen for each criteria, a person must screen positive for symptoms by reporting a score of 3 or more on the specific symptom criterion.|change in CAPS score from baseline to 3 months posttreatment||||units on a scale||Standard Deviation|Mean
2675106|NCT01449955|Primary|Clinician Administered Posttraumatic Stress Disorder Scale (CAPS)|Clinician administered interview which assesses the symptoms of Posttraumatic Stress disorder at baseline, and then again 1 month posttreatment. The CAPS is a 25 item semi-structured interview that assesses the 17 DSM-IV PTSD criteria as well as social and occupational impairment. For each item the participant can respond with a rating of 0-8 (with 0 indicating no symptom severity and frequency and 8 indicating extreme symptom severity and frequency). The range of total scores on a CAPS is from 0-136, with a greater score indicating greater PTSD symptom severity. The total score is computed by summing the aforementioned 17 items. Additionally, the CAPS assesses for a positive PTSD diagnosis by assessing for the three DSM-IV criteria of B, C, and D. In order to meet a positive screen for each criteria, a person must screen positive for symptoms by reporting a score of 3 or more on the specific symptom criterion.|Baseline and 1 month posttreatment||||scores on a scale||Standard Deviation|Mean
2675107|NCT01449929|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Convenience Score at Week 4, Week 24, and Week 48|Participant treatment satisfaction was measured using the self-reported scale (HIVTSQ), which consists of 10 items (1-satisfaction, 2-HIV control, 3-adverse effects, 4-level of demand, 5-convenience, 6-flexibility, 7-knowledge, 8-life habits, 9-recommendability, and 10-willingness to continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The convenience score is the score for item 5 (range: 0-6). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the HIVTSQ mITT-E population.|Week 4, Week 24, and Week 48|HIVTSQ mITT-E Population.|||Scores on a scale||Standard Deviation|Mean
2675108|NCT01449929|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Lifestyle/Ease Sub Score at Week 4, Week 24, and Week 48|Participant treatment satisfaction was measured using the self-reported scale (HIVTSQ), which consists of 10 items (1-satisfaction, 2-HIV control, 3-adverse effects, 4-level of demand, 5-convenience, 6-flexibility, 7-knowledge, 8-life habits, 9-recommendability, and 10-willingness to continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The lifestyle/ease score is the sum of items 4, 5, 6, 7 and 8 (range: 0-30). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the HIVTSQ mITT-E population.|Week 4, Week 24, and Week 48|HIVTSQ mITT-E Population.|||Scores on a scale||Standard Deviation|Mean
2675109|NCT01449929|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Total Score at Week 4, Week 24, and Week 48|Participant treatment satisfaction was measured using the self-reported scale (HIVTSQ), which consists of 10 items (1-satisfaction, 2-HIV control, 3-adverse effects, 4-level of demand, 5-convenience, 6-flexibility, 7-knowledge, 8-life habits, 9-recommendability, and 10-willingness to continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The treatment satisfaction score (range: 0-60) was the sum of the individual items. HIVTSQ mITT-E Population=Only participants from USA, France, Germany, Italy, Spain for whom valid translations were available from the mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the HIVTSQ mITT-E population.|Week 4, Week 24, and Week 48|HIVTSQ mITT-E Population.|||Scores on a scale||Standard Deviation|Mean
2675118|NCT01449929|Secondary|Change From Baseline in CD4+ and CD8+ Cell Counts|Change from Baseline in CD4+ cell counts was assessed at Weeks 4, 8, 12, 16, 36 and 48. Change from Baseline in CD8+ cell counts was assessed at Weeks 4, 12, 24 and 48. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits and parameters, so the overall number of participants analyzed reflects everyone in the mITT-E Population.|Baseline and Weeks 4, 8, 12, 16, 36 and 48 for CD4+ and Baseline and Weeks 4, 12, 24 and 48 for CD8+|mITT-E Population.|||Cells per millimeters cubed (cells/mm^3)||Standard Deviation|Mean
2675110|NCT01449929|Secondary|Change From Baseline in EQ-5D Thermometer Scores at Week 24 and Week 48|The European Quality of Life -5 Dimensions (EQ-5D) is a 5-question quality of life instrument that provides a utility score and visual analogue scale score that describes the participants' health status. The primary reason for including the EQ-5D is to elicit utility values for potential cost-effectiveness analysis for submission to health technology assessment agencies. Thermometer score is based on a visual analogue scale (VAS) ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).Values represented are for adjusted mean. Estimates are calculated from an ANCOVA model adjusting for age, sex, race, Baseline viral load, background dual NRTI therapy and Baseline EQ-5D thermometer score. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24, and Week 48|mITT-E Population.|||Scores on a scale||Standard Error|Mean
2675111|NCT01449929|Secondary|Change From Baseline in European Quality of Life -5 Dimensions (EQ-5D) Utility Scores at Week 24 and Week 48|The EQ-5D is a 5-question quality of life instrument that provides a utility score and visual analogue scale score that describes the participants' health status. The primary reason for including the EQ-5D is to elicit utility values for potential cost-effectiveness analysis for submission to health technology assessment agencies. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome. Values represented are for adjusted mean. Estimates are calculated from an ANCOVA model adjusting for age, sex, race, baseline viral load, background dual NRTI therapy and Baseline EQ-5D utility score. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Week 24, and Week 48|mITT-E Population.|||Scores on a scale||Standard Error|Mean
2675112|NCT01449929|Secondary|Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Bother Score at Week 4, Week 24, and Week 48|SDM is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Each item is rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health). Values represented are for adjusted mean. Estimates are calculated from an ANCOVA model adjusting for age, sex, race, baseline viral load, background dual NRTI therapy and baseline symptom bother score. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. A positive change from Baseline indicates a decline in a participant's quality of life over that period.|Baseline, Week 4, Week 24, and Week 48|mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the mITT-E Population.|||Scores on a scale||Standard Error|Mean
2675113|NCT01449929|Secondary|Number of Participants (Par.) With Detectable Virus That Has Genotypic or Phenotypic Evidence of Treatment-emergent Resistance to DTG, DRV+RTV and Other On-study ART at Time of Protocol Defined Virology Failure (PDVF)|An assessment was made of every change across all amino acids within the integrase (IN), reverse transcriptase (RT), and Protease (PRO) encoding region at Baseline and at time of suspected PDVF. PDVF is defined as the confirmed plasma HIV-1 RNA >200 c/mL >=Week 24. PDVF Genotypic Population included all participants in the mITT-E population with available on-treatment genotypic resistance data, at time of PDVF. Only those participants with data available at the specified time points were analyzed.|Baseline until PDVF up to Week 48|PDVF Genotypic Population|||Participants|||Number
2675114|NCT01449929|Secondary|Number of Participants With the Indicated Grade 3 and Grade 4 Maximum Post-Baseline Chemistry and Hematology Laboratory Toxicities|Hematology and clinical chemistry data were summarized according to the division of AIDS (DAIDS) table for grading the Severity of adverse events, version 1.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred.|From Baseline through Week 48|mSafety Population|||Participants|||Number
2675115|NCT01449929|Secondary|Percentage of Participants With Grade 2 or Higher Abnormalities in Fasting LDL Cholesterol Through Week 48|Hematology and clinical chemistry data were summarized according to the division of AIDS (DAIDS) table for grading the Severity of adverse events, version 1.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for which an increase in fasting LDL cholesterol to Grade 2 or higher occurred. Only those participants with data available at the specified time points were analyzed.|From Baseline through Week 48|mSafety Population.|||Percentage of Participants|||Number
2675116|NCT01449929|Secondary|Change From Baseline in Fasting Low-density Lipoprotein (LDL) Cholesterol Through Week 48|Fasting LDL cholesterol change from Baseline was analyzed. Values represented are for adjusted means. Estimates are calculated from a repeated measures model including the following covariates: treatment, visit, Baseline plasma HIV-1 RNA, background dual NRTI therapy, Baseline LDL cholesterol, treatment*visit interaction and Baseline LDL cholesterol*visit interaction. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed.|From Baseline through Week 48|mSafety Population.|||Millimoles per liter (mmol/L)||Standard Error|Mean
2675117|NCT01449929|Secondary|Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shift to CDC Class C, or New CDC Class C or Death at Week 48|The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|Week 48|mITT-E Population|||Participants|||Number
2675119|NCT01449929|Secondary|Change From Baseline in Plasma HIV-1 RNA (log10 c/mL) at Weeks 4, 8, 12, 16, 24, 36 and 48|Change from Baseline in plasma HIV-1 RNA (log10 c/mL) was assessed at Weeks 4, 8, 12, 16, 24, 36 and 48 . Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the mITT-E Population.|Baseline, Weeks 4, 8, 12, 16, 24, 36 and 48|mITT-E Population.|||Log10 copies per mL||Standard Deviation|Mean
2675120|NCT01449929|Secondary|Percentage of Participants With Plasma HIV-1 RNA <400 c/mL at Week 48|"The percentage of participants with Plasma HIV-1 RNA <400 c/mL at Week 48 was assessed MSDF, as codified by the FDA snapshot algorithm. This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the snapshot window (Week 48 +/- 6 weeks)."|Week 48|mITT-E Population|||Percentage of participants|||Number
2675121|NCT01449929|Secondary|Time to Virologic Suppression (<50 Copies/mL) Through Week 48|The time to viral suppression (i.e. first viral load value <50 copies/mL) through Week 48 was derived and summarized using Kaplan-Meier plots. Participants who withdrew for any reason without having suppressed prior to the analysis were censored. Confidence intervals were estimated using the Brookmeyer-Crowley method.|From Baseline through Week 48|mITT-E Population|||Days||95% Confidence Interval|Median
2675122|NCT01449929|Primary|Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48|"Assessment was done using Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) snapshot algorithm.This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the snapshot window (Week 48 +/- 6 weeks). Modified Intent-To-Treat Exposed (mITT-E) Population:all randomized participants who received at least one dose of investigational product"|Week 48|mITT-E Population|||Percentage of participants|||Number
2675123|NCT01449864|Primary|Acute Toxicity|Measured by experience of adverse events|90 days||||Participants|||Count of Participants
2675124|NCT01449864|Primary|Serious Adverse Events|Serious Adverse Events preventing more than 25% of planned treatments using proton radiotherapy.|90 days||||Participants|||Count of Participants
2675125|NCT01449812|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 up to Month 1)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who had received the booster dose and for whom data were available.|||Participants|||Count of Participants
2675126|NCT01449812|Secondary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who had received the booster dose and for whom data were available.|||Participants|||Count of Participants
2675127|NCT01449812|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.1 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with the symptoms sheet filled in, who had received the booster dose and for whom data were available.|||Participants|||Count of Participants
2675128|NCT01449812|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated Cohort, which included all subjects with the symptoms sheet filled in, who had received the booster dose and for whom data were available.|||Participants|||Count of Participants
2675129|NCT01449812|Primary|Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN|Booster response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
2675130|NCT01449812|Primary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2675131|NCT01449812|Primary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2675132|NCT01449812|Primary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN|A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
2675133|NCT01449812|Primary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN|A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA units per milliliter (EL.U/mL).|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
2675134|NCT01449812|Primary|Anti-polio Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2675135|NCT01449812|Primary|Anti-polio Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ the value of 8.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Titers||95% Confidence Interval|Geometric Mean
2675136|NCT01449812|Primary|Number of Seroprotected Subjects Against Polio Type 1, 2 and 3|A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentrations ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
2675137|NCT01449812|Primary|Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3|A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentration ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
2675138|NCT01449812|Primary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2675139|NCT01449812|Primary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 micrograms per milliliter (µg/mL).|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2675140|NCT01449812|Primary|Number of Seroprotected Subjects Against PRP|A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
2675141|NCT01449812|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)|A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 µg/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
2675142|NCT01449812|Primary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as GMCs for the seroprotection cut-off of ≥ 0.1 IU/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2675155|NCT01449747|Primary|Plasma Concentration of Total Glucose-dependent Insulinotropic Polypeptide (GIP) Before and After Sitagliptin Treatment|Plasma concentrations of total GIP were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurement of total GIP were measured with MTT after taking sitagliptin 100 mg 1 hour before the test.|0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose||||pmol/L||Standard Deviation|Mean
2675143|NCT01449812|Primary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2675144|NCT01449812|Primary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids|A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.|One month after the booster vaccination (At Month 1)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
2675145|NCT01449812|Primary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids|A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.|||Participants|||Count of Participants
2675146|NCT01449812|Primary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2675147|NCT01449812|Primary|Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)|A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.|||Participants|||Count of Participants
2675148|NCT01449812|Primary|Anti-polio Type 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.|||Titers||95% Confidence Interval|Geometric Mean
2675149|NCT01449812|Primary|Number of Seroprotected Subjects Against Polio Type 1, 2 and 3|A seroprotected subject was defined as a vaccinated subject with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value of 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.|||Participants|||Count of Participants
2675150|NCT01449812|Primary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.|||µg/mL||95% Confidence Interval|Geometric Mean
2675151|NCT01449812|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP)|A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.|||Participants|||Count of Participants
2675152|NCT01449812|Primary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL.|Before the booster vaccination (At Day 0)|The analysis was performed on the ATP cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.|||IU/mL||95% Confidence Interval|Geometric Mean
2675153|NCT01449812|Primary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids|A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|Before the booster vaccination (At Day 0)|The analysis was performed on the According-to-Protocol (ATP) cohort for analysis of antibody persistence, which included all subjects who have completed their full three-dose primary vaccination course in the DTPA-IPV-056 study and for whom serological results were available at the persistence time point.|||Participants|||Count of Participants
2675154|NCT01449747|Primary|Change in AUC of Active GLP-1, Total GLP-1 and Total GIP Between Before and After Sitagliptin Treatment|Plasma concentrations of active GLP-1, total GLP-1 and total GIP were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurements were measured with MTT after taking sitagliptin 100 mg 1 hour before the test. Comparisons were made using Area under the curve (AUC) values and incremental area under the curve (ΔAUC) of active GLP-1, total GLP-1 and total GIP before and after the addition of sitagliptin.|0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose||||pmol*min/L||Standard Deviation|Mean
2675156|NCT01449747|Primary|Plasma Concentration of Total GLP-1 Before and After Sitagliptin Treatment|Plasma concentrations of total GLP-1 were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test. Second measurement of total GLP-1 were measured with MTT after taking sitagliptin 100 mg 1 hour before the test.|0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose||||pmol/L||Standard Deviation|Mean
2675157|NCT01449747|Secondary|Differences of DPP-4 Activity After Sitagliptin Treatment Between Responder and Non-responder Groups|The DPP-4 activity was measured at baseline and 0, 15, 30, 45 and 60 min during the meal tolerance test. Second measurement of DPP-4 activity was measured with MTT after taking sitagliptin 100 mg 1 hour before the test. Plasma DPP-4 activity during meal tolerance test is expressed as percentage activity relative to baseline. DPP-4 activity % was calculated using the following formula : (DPP-4 activity at time t / Baseline DPP-4 activity) × 100.|0, 15, 30, 45, 60 min post-dose||||percentage of DPP4 activity||Standard Deviation|Mean
2675158|NCT01449747|Primary|Plasma Concentration of Active Glucagon-like Peptide 1 (GLP-1) Before and After Sitagliptin Treatment|Plasma concentrations of active GLP-1 were measured at 0, 15, 30, 45, 60, 90, 120 and 180 min during the meal tolerance test (MTT). Second measurement of active GLP-1 were measured with MTT after taking sitagliptin 100 mg 1 hour before the test.|0, 15, 30, 45, 60, 90, 120, 180 min pre and post-dose||||pmol/L||Standard Deviation|Mean
2675159|NCT01449734|Primary|Family Satisfaction in the ICU (FS-ICU) Questionnaire- Overall Satisfaction Score|Overall satisfaction score is calculated as the mean of 24 Items concerning satisfaction with care, communication and decision-making. After transformation of Items the score has a scale reaching from 0 (highly unsatisfied) to 100 (highly satisfied).|From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months|By invitation|||units on a scale||Standard Deviation|Mean
2675160|NCT01449734|Secondary|Patient Mortality||From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months|||||||
2675161|NCT01449734|Secondary|Patient Length of Stay on the ICU||From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months|||||||
2675162|NCT01449734|Secondary|Patient Severity of Illness||From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months|||||||
2675163|NCT01449721|Secondary|Number of Participants With Experiencing Complications Related to Intravascular Volume Overload|"Composite safety endpoint:~Premature termination of the protocol-directed intravenous fluid administration by the investigator or primary physician due to presumed volume overload~Administration of intravenous diuretic for acute pulmonary edema~Respiratory failure requiring ventilatory assistance (BiPAP, CPAP, or mechanical ventilation) secondary to pulmonary edema per primary care team"|12 hours following treatment initiation||||Participants|||Count of Participants
2675164|NCT01449721|Secondary|In-hospital Mortality|Any occurrence of mortality while the participant is in-hospital is counted as an outcome.|In-hospital discharge or up to maximum 30 days||||Participants|||Count of Participants
2675165|NCT01449721|Primary|Number of Participants With Worsening Organ System Dysfunction Defined by SOFA Score Increase ≥ 1|"Development of worsening organ failure defined by the Sequential Organ Failure Assessment (SOFA) score. The SOFA score defines the presence and severity of dysfunction within 6 organ systems (cardiovascular, respiratory, coagulation, liver, renal, and nervous system) with a value of 0 for assigned to normal function to a maximum value of 4 for severe dysfunction in each of the organ systems. Each component of the SOFA score is added together, ranging from 0 indicating no organ dysfunction in any of the 6 organ systems, to 24 indicating maximal organ dysfunction across all 6 organ systems.~Within this trial, the occurrence of organ failure was defined by any increase in the total SOFA score by ≥ 1 point over the first 72 hours after randomization."|72 hours||||Participants|||Count of Participants
2675166|NCT01449708|Secondary|PONV Between Different Surgical Procedures (Percentage of Participants)||24 hours|analysis was conducted with all participants and NOT per arm|||percentage of participants|||Number
2675167|NCT01449708|Secondary|Number of Patients Requiring Antiemetic Rescue Medication (AERM)||24hours||||participants|||Number
2675168|NCT01449708|Primary|PONV During the First 24 Hours After Bariatric Surgery|Postoperative Nausea and Vomiting|24 hours||||participants|||Number
2675169|NCT01449682|Secondary|To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups||baseline to 48 weeks||||microns||Standard Error|Mean
2675170|NCT01449682|Secondary|To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups||baseline to 48 weeks||||ETDRS letters||Standard Error|Mean
2675171|NCT01449682|Primary|Macular Function Using Multi-focal ERG|To determine if there is a change in central amplitude responses using multifocal ERG at 48 weeks compared to baseline values for both the PRN and Q16weeks treatment groups|baseline to 48 weeks||||nV/deg2||Standard Error|Mean
2675172|NCT01449682|Primary|Macular Function Using Microperimetry|To determine if there is change in mean macular sensitivity using microperimetry at 48 weeks compared to baseline for both the PRN and Q16weeks treatment groups|baseline to 48 weeks||||dB||Standard Error|Mean
2675173|NCT01449630|Secondary|Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Thromboxane A Metabolite (TXAM)|The participant's urine was collected during protocol-defined intervals and the PGE metabolite TXAM was assessed. TXAM results for each interval were then compared to the baseline value.|0 to 2, 2 to 4, 4 to 6, and 6 to 12 hours post dose|All participants who received at least 1 dose of study drug or placebo with evaluable TXAM data at specific time points.|||percentage change in TXAM||Standard Deviation|Mean
2675174|NCT01449630|Secondary|Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostacyclin Metabolite (PGIM)|The participant's urine was collected during protocol-defined intervals and the PGE metabolite PGIM was assessed. PGIM results for each interval were then compared to the baseline value.|0 to 2, 2 to 4, 4 to 6, and 6 to 12 hours post dose|All participants who received at least 1 dose of study drug or placebo with evaluable PGIM data at specific time points|||percentage change in PGIM||Standard Deviation|Mean
2675321|NCT01447719|Other Pre-specified|Median Sensitivity and Specificity vs. CERAD Diagnosis|Median sensitivity and specificity for 5 independent readers to detect moderate to frequent amyloid plaques (per CERAD criteria).|at autopsy within 24 months of florbetapir PET scan||||percentage of true positives/negatives||Full Range|Median
2675175|NCT01449630|Secondary|Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostaglandin E(2) Metabolite (PGEM)|The participant's urine was collected during protocol-defined intervals and the PGE metabolite PGEM was assessed. PGEM results for each interval were then compared to the baseline value.|0 to 2, 2 to 4, 4 to 6, 6 to 12 and 12 to 24 hours post dose|All participants who received at least 1 dose of study drug or placebo with evaluable PGEM data at specific time points.|||percentage change in PGEM||Standard Deviation|Mean
2675176|NCT01449630|Secondary|Pharmacodynamics: Percent Change From Baseline of Ex Vivo Whole Blood Prostaglandin E (PGE) Synthesis After Lipopolysaccharide (LPS) Stimulation|The effect of LY3031207 on PGE synthesis in whole blood after ex vivo LPS stimulation.|Predose, 0.5, 1, 2, 8, 24 and 144 hours post dose.|All participants who received at least 1 dose of study drug or placebo with evaluable PGE data at the specific time points.|||percentage change in PGE||Standard Deviation|Mean
2675177|NCT01449630|Secondary|Pharmacokinetics: Maximum Concentration (Cmax) of LY3031207||Predose, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, 96, 144 hours post dose|Pharmacokinetic (PK) population: all participants who received at least one dose of study drug and had evaluable PK data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2675178|NCT01449630|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of LY3031207|AUC from time 0 to last timepoint (AUC0-tlast) with measurable concentration of LY3031207.|Predose, 0.25, 0.5, 1, 2, 4, 8, 12, 24, 48, 96, 144 hours post dose|Pharmacokinetic (PK) population: All participants who received at least 1 dose of study drug and had evaluable PK data.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2675179|NCT01449630|Primary|Number of Participants With 1 or More Drug Related Adverse Events (AE) or Any Serious AE|AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible drug relatedness, is located in the Reported Adverse Event module.|Baseline, up to 4 months|All participants who received at least 1 dose of study drug or placebo.|||Participants|||Count of Participants
2675180|NCT01449539|Primary|Number of Stem Cells Collected|Total stem cells collected from all participants at one week post-study treatment|one week post-treatment|Four of eight enrolled subjects completed the study.|||stem cells|||Number
2675181|NCT01449526|Secondary|Slit Lamp > Grade 2|Proportion of eyes with any slit lamp findings greater than grade 2 at any visit between the Test and Control lenses.|3 months|Number of dispensed eyes with non-missing scores in each treatment group.|||eyes (2 per participant)|Participants||Number
2675182|NCT01449526|Primary|Visual Acuity (VA)|Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. This measure is an average from 4 visits taking place over 3 months.|4 visits over 3 months|All Eligible, Dispensed Eyes|||LogMAR|Participants|Standard Deviation|Least Squares Mean
2675183|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM in normal skin|Baseline to Day 57|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675184|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin|Baseline to Day 57|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675185|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 57|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675186|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel,0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin|Baseline to Day 8|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675187|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin|Baseline to Day 8|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675188|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 8|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675189|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin|Baseline to Day 3|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675190|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin|Baseline to Day 3|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675350|NCT01447433|Secondary|Change in Fasting Plasma Glucose||Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||mmol/L||Standard Deviation|Mean
2675191|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM(Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 3|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675192|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin|Baseline to Day 2|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675193|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin|Baseline to Day 2|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675194|NCT01449513|Primary|Change in Degree of Necrosis|Change from baseline in the degree of necrosis in the epidermis following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 2|As stated in the outcome measure, the degree of necrosis will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675195|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin~The degree of infiltration of the epidermis by inflammatory cells will be based on inflammation/small bright cells (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on inflammatory cells in the dermis (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 57|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675196|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin~The degree of infiltration of the epidermis by inflammatory cells will be based on inflammation/small bright cells (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on inflammatory cells in the dermis (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 57|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675197|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin~The degree of infiltration of the epidermis by inflammatory cells will be based on inflammation/small bright cells (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on inflammatory cells in the dermis (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 57|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675198|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin~The degree of infiltration of the epidermis by inflammatory cells will be based on inflammation/small bright cells (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on inflammatory cells in the dermis (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 8|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675199|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin~The degree of infiltration of the epidermis by inflammatory cells will be based on inflammation/small bright cells (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on inflammatory cells in the dermis (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 8|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675208|NCT01449461|Secondary|Duration of Intracranial Response|Intracranial duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR in brain metastases (whichever is first recorded) until the first date that progressive disease is objectively documented or death due to any cause. Participants who did not progress nor die were censored at the last valid response assessment. Duration intracranial of response was calculated by Kaplan-Meier estimation.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set. ALK+ NSCLC participants with measurable and only non-measurable brain metastases at baseline were evaluated for this outcome measure.|||months||95% Confidence Interval|Median
2675200|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin~The degree of infiltration of the epidermis by inflammatory cells will be based on inflammation/small bright cells (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on inflammatory cells in the dermis (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 8|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675201|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin~The degree of infiltration of the epidermis by inflammatory cells will be based on inflammation/small bright cells (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on inflammatory cells in the dermis (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 3|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675202|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in Sub AK (actinic keratosis) skin.~The degree of infiltration of the epidermis by inflammatory cells will be based on inflammation/small bright cells (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on inflammatory cells in the dermis (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 3|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675203|NCT01449513|Primary|Change in Degree of Infiltration|Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in AK (actinic keratosis) skin|Baseline to Day 3|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675204|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by RCM (Reflectance Confocal Microscopy) in normal skin.~The degree of infiltration of the epidermis by inflammatory cells will be based on inflammation/small bright cells (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on inflammatory cells in the dermis (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 2|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675205|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by Reflectance Confocal Microscopy (RCM) in Sub actinic keratosis (AK) skin.~The degree of infiltration of the epidermis by inflammatory cells will be based on inflammation/small bright cells (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on inflammatory cells in the dermis (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 2|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage of change||Standard Deviation|Mean
2675206|NCT01449513|Primary|Change in Degree of Infiltration|"Change from baseline in the degree of infiltration of the epidermis by inflammatory cells following treatment with ingenol mebutate gel, 0.05% as assessed by Reflectance Confocal Microscopy (RCM) in actinic keratosis (AK) skin.This RCM imaging technique is a relatively new non-invasive, real-time evaluation method to generate horizontal skin sections at a resolution comparable to routine histology.~The degree of infiltration of the epidermis by inflammatory cells will be based on inflammation/small bright cells (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel. The degree of infiltration of the dermis by inflammatory cells will be based on inflammatory cells in the dermis (grading 0-3) as assessed by RCM from baseline across the trial period for the subjects receiving PEP005 Gel."|Baseline to Day 2|As stated in the outcome measure, the degree of infiltration will be assessed for subjects receiving Ingenol Mebutate Gel. Therefor this is 0 for all subjects receiving vehicle.|||percentage change||Standard Deviation|Mean
2675207|NCT01449461|Secondary|Intracranial Progression Free Survival (PFS)|PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression in brain, or death due to any cause, whichever occurs first. Intracranial PFS was calculated by Kaplan-Meier estimation.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set. ALK+ NSCLC participants with measurable and only non-measurable brain metastases at baseline were evaluated for this outcome measure.|||months||95% Confidence Interval|Median
2675230|NCT01449370|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|PK population included all participants who took at least 1 dose of study drug and had sufficient concentration-time data to calculate PK parameters.|||hr||Full Range|Median
2675209|NCT01449461|Secondary|Intracranial Objective Response Rate|Intracranial objective response rate is defined as the proportion of the participants with CR or PR in the intracranial CNS per modification of RECIST v1.1 after the initiation of study drug. CR for target lesion: disappearance of all extranodal lesions. CR for non-target lesion: disappearance of all extranodal non-target lesions and normalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. Meta.=Metastases.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set. ALK+ NSCLC participants with measurable and only non-measurable brain metastases at baseline were evaluated for this outcome measure. Here, n is the number of participants who were evaluable for specific category.|||percentage of participants||95% Confidence Interval|Number
2675210|NCT01449461|Secondary|Overall Survival (OS)|OS is defined as the time interval from the date of the first dose of the study treatment until death due to any cause.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set. Participants with anaplastic lymphoma kinase (ALK) and non-small cell lung cancer (NSCLC) were evaluated for this outcome measure.|||months||95% Confidence Interval|Median
2675211|NCT01449461|Secondary|Progression Free Survival (PFS)|PFS is defined as the time interval from the date of the first dose of the study treatment until the first date at which disease progression is objectively documented, or death due to any cause, whichever occurs first. Disease progression for target lesion: SLD increased by at least 20% from the smallest value on study (including baseline, if that is the smallest) and SLD must also demonstrate an absolute increase of at least 5 mm or development of any new lesion. Disease progression for non-target lesion: Unequivocal progression of existing non-target lesions. (Subjective judgment by experienced reader). PFS was calculated by Kaplan-Meier estimation.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set. Participants with anaplastic lymphoma kinase (ALK) and non-small cell lung cancer (NSCLC) were evaluated for this outcome measure. Here 'n' is participants analysed for each category.|||months||95% Confidence Interval|Median
2675212|NCT01449461|Secondary|Duration of Response|Duration of response is defined as time interval from the time that measurement criteria are first met for CR/PR (whichever is first recorded) until first date that progressive disease is objectively documented or death due to any cause. Participants who did not progress nor die were censored at last valid response assessment. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in SLD of target lesions. PD for target lesion: SLD increased by at least 20% from smallest value and must also demonstrate an absolute increase of at least 5 mm or development of any new lesion. PD for non-target lesion: unequivocal progression of existing non-target lesions.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|FAS. Participants who were responders among those who were had anaplastic lymphoma kinase (ALK) and non-small cell lung cancer (NSCLC) were evaluated for this outcome measure. Here 'n' is participants analysed for each category. Duration of response was calculated by Kaplan-Meier estimation.|||months||95% Confidence Interval|Median
2675213|NCT01449461|Secondary|Best Overall Response|Best overall response is defined as proportion of participants with CR, PR, stable disease (SD) or progressive disease (PD) as per of RECIST v1.1 as evaluated by investigator. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the SLD of target lesions, taking as reference the baseline sum diameters. Disease progression for target lesion: SLD increased by at least 20% from smallest value on study and SLD must also demonstrate an absolute increase of at least 5 mm or development of any new lesion. PD for non-target lesion: unequivocal progression of existing non-target lesions. SD for neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set. Participants with anaplastic lymphoma kinase (ALK) and non-small cell lung cancer (NSCLC) were evaluated for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2675214|NCT01449461|Secondary|Terminal Phase Elimination Half-life (T1/2) for Brigatinib||Cycle 2 Day 1|Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.|||hours||Standard Deviation|Mean
2675215|NCT01449461|Secondary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Brigatinib||Cycle 1 Day 1, 8, 15 and 22 pre-dose and Day 1 multiple timepoints (up to 48 hours) post-dose; Cycle 2 Day 1 and 3 pre-dose and Day 1 multiple time points (up to 48 hours) post-dose|Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.|||h*ng/mL||Standard Deviation|Mean
2675216|NCT01449461|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Brigatinib||Cycle 2 Day 1|Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib.|||hour||Standard Deviation|Mean
2675217|NCT01449461|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Brigatinib||Cycle 1 Day 1|Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Participants of brigatinib 90 mg QD-180 mg QD arm were included as per treatment received at each time point.|||hours||Standard Deviation|Mean
2675218|NCT01449461|Secondary|Cmax: Maximum Observed Plasma Concentration for Brigatinib||Cycle 2 Day 2|Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here number of participants analyzed is the participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2675219|NCT01449461|Secondary|Cmax: Maximum Observed Plasma Concentration for Brigatinib||Cycle 1 Day 1|Analysis was performed on all enrolled participants in the study who received at least one dose of brigatinib. Here number of participant analyzed is the participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Mean
2675220|NCT01449461|Secondary|Number of Participants With Dose Limiting Toxicities (DLTs) Assessed in Dose Escalation Phase of the Study|DLT include any toxicity that is possibly, probably, or definitely drug-related. Toxicity grades will be defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.0. DLTs are defined by the following: A) Non-hematologic toxicities: Any grade ≥3 non-hematologic toxicity, with the exception of self-limiting or medically controllable toxicities (eg, nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting < 3 days, and excluding alopecia. B) Hematologic toxicities: Febrile neutropenia not related to underlying disease (fever, > 101°F; ANC<500); Prolonged grade 4 neutropenia (> 7 days); Neutropenic infection: ≥ grade 3 neutropenia with ≥ grade 3 infection; Thrombocytopenia ≥ grade 3 with bleeding or grade 4 lasting ≥ 7 days. C) Missed ≥ 25% of planned doses of brigatinib over 28 days due to treatment-related AEs in the first cycle.|Up to Cycle 1 (28 days)|Safety population included all enrolled participants who received at least one dose of study drug.|||participants|||Number
2675221|NCT01449461|Secondary|Maximum Tolerated Dose (MTD) Assessed in Dose Escalation Phase of the Study|The MTD is defined as the highest dose at which ≤ 1 of 6 evaluable participants experience a DLT within the first 28 days of treatment (end of cycle 1). Evaluable participants must complete at least 75% of their planned doses, unless missed doses are due to AEs. The cohort may be expanded to better define the safety profile for confirmation of the MTD. The maximum administered dose in the trial will likely exceed the MTD.|Up to Cycle 1 (28 days)|Safety population included all enrolled participants who received at least one dose of study drug. MTD was not formally determined.|||mg|||Number
2675222|NCT01449461|Secondary|Number of Participants Who Had at Least One Treatment-Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Any adverse event reported on or after the day of first dose of study drug (approximately up to 50 months)|Safety population included all enrolled participants who received at least one dose of study drug.|||participants|||Number
2675223|NCT01449461|Primary|Objective Response Rate (ORR)|ORR assessed by the investigator, is defined as the proportion of the participants with complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid tumors (RECIST) v1.1 after the initiation of study treatment. CR for target lesion: disappearance of all extranodal lesions and all pathological lymph nodes must have decreased to <10 mm in short axis. CR for non-target lesion: Disappearance of all extranodal non-target lesions, all lymph nodes must be non-pathological in size (<10mm short axis) and normalization of tumor marker level. PR: at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters. Crzb=Crizotinib.|Screening and at 8-week intervals thereafter up to data cut-off date: 16 November 2015 (approximately up to 50 months)|Full analysis set (FAS) included all participants who received at least one dose of study drug. Participants with anaplastic lymphoma kinase (ALK) and non-small cell lung cancer (NSCLC) were evaluated for this outcome measure. Here, n is the number of participants who were evaluable for specific category.|||percentage of participants||95% Confidence Interval|Number
2675224|NCT01449461|Primary|Recommended Phase 2 Dose of Brigatinib|The RP2D is the maximum tolerated dose (MTD) or less. The MTD is defined as the dose range at which ≤ 1 of 6 evaluable participants experience dose limiting toxicities (DLT) within the first 28 days of treatment (end of cycle 1).|28 days|Safety population included all enrolled participants who received at least one dose of study drug.|||mg||Full Range|Mean
2675225|NCT01449370|Secondary|Percent Change From Baseline in Pharmacodynamic Markers|"Pharmacodynamic markers included phosphorylated ribosomal protein S6 (PS6), phosphorylated eukaryotic initiation factor 4E-binding protein 1 (P4EBP1), phosphorylated N-myc downstream regulated gene 1 (PNDRG1), phosphorylated proline-rich AKT substrate of 40 kilodaltons (PPRAS40), and phosphorylated serine/threonine protein kinase AKT (PAKT). Analysis population (n) for each skin biopsy biomarker is as follow: P4EBP1 (n=6,6,6,2,2,0,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PAKT and PNDRG1 (n=6,6,7,2,2,0,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PPRAS40 (n= 6,0,6,2,2,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PS6 (n=6,6,7,2,2,0,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0).n for each tumor tissue biomarkers is as follow: P4EBP1, PAKT, PNDRG1, and PS6 (n=1,1,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PPRAS40 (n= 1,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0)."|Cycle 1 Day 8|Asat population where baseline and post-baseline assessments were available. The ASat population included all enrolled participants who received at least 1 dose of TAK-117.|||percent change||Standard Deviation|Mean
2675226|NCT01449370|Secondary|%AUC Extrapolated: Percentage of Area Under Concentration-extrapolated||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|No data is reported since serum concentration of TAK-117 were below the limit of quantification.||||||
2675227|NCT01449370|Secondary|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-117||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|No data is reported since serum concentration of TAK-117 were below the limit of quantification.||||||
2675228|NCT01449370|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-117||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|PK population included all participants who took at least 1 dose of study drug and had sufficient concentration-time data to calculate PK parameters.|||nanogram hours per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2675229|NCT01449370|Secondary|T 1/2z: Terminal Disposition Phase Half-life for TAK-117||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|PK population included all participants who took at least 1 dose of study drug and had sufficient concentration-time data to calculate PK parameters.|||hrs||Standard Deviation|Mean
2675351|NCT01447433|Secondary|Change in Lipid-lipoprotein Profile||Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||mmol/L||Standard Deviation|Mean
2675231|NCT01449370|Secondary|Ctrough: Observed Concentration at the End of Dosing Interval for TAK-117||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|PK population included all participants who took at least 1 dose of study drug and had sufficient concentration-time data to calculate PK parameters.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2675232|NCT01449370|Secondary|Cmax: Maximum Observed Plasma Concentration for TAK-117||Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose|Pharmacokinetic (PK) population included all participants who took at least 1 dose of study drug and had sufficient plasma concentration-time data to calculate PK parameters.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2675233|NCT01449370|Secondary|Clinical Benefit Rate (CBR)|Clinical benefit rate was defined as the participants who achieved stable disease (SD) for at least 15 weeks, CR, or PR. The estimate of the CBR was calculated as crude percentage of participants whose best ORR was CR, PR or SD for at least 90 days.|Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death|The FAS population included participants who received at least 1 dose of TAK-117, baseline data for those analyses that required baseline data and postbaseline endpoint data subsequent to at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2675234|NCT01449370|Secondary|Duration of Objective Response|Duration of response was to be calculated for participants who achieved CR or PR. Duration of objective response was defined as the number of days from the start date of PR or CR (whichever response was achieved first) to the first date that PD or disease progression was objectively documented. The duration of objective response was to be right-censored for participants who achieved CR or PR and met 1 of the following conditions: Non-protocol anticancer treatment started before documentation of PD; Documented PD after more than 1 missed disease assessment visit; Alive and did not have documentation of PD before a data analysis cutoff date.|Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death|The duration of objective response analysis was not performed due to change in planned analysis.||||||
2675235|NCT01449370|Secondary|Overall Response Rate (ORR)|The estimate of the ORR is calculated as crude percentage of participants who's best overall response is complete response (CR) or partial response (PR). Objective response (CR and PR) as determined by the participants best tumor response was assessed using response evaluation criteria in solid tumors (RECIST) version 1.1. As per RECIST version 1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 millimeter [mm]). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease was defined as not qualifying for CR, PR, and progressive disease (PD).|Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death|The full analysis set (FAS) population included participants who received at least 1 dose of TAK-117, baseline data for those analyses that required baseline data and postbaseline endpoint data subsequent to at least 1 dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2675236|NCT01449370|Primary|Number of Participants With Clinically Meaningful Changes in Electrocardiogram (ECG)||Baseline up to Cycle 27 Day 45|The ASat population included all enrolled participants who received at least 1 dose of TAK-117.|||participants|||Number
2675237|NCT01449370|Primary|Number of Participants With Clinically Meaningful Changes in Vital Signs||Baseline up to Cycle 27 day 45|The ASat population included all enrolled participants who received at least 1 dose of TAK-117.|||participants|||Number
2675238|NCT01449370|Primary|Number of Participants With Clinically Meaningful Changes in Laboratory Values||Baseline up to Cycle 27 Day 45|The ASat population included all enrolled participants who received at least 1 dose of TAK-117.|||participants|||Number
2675239|NCT01449370|Primary|Number of Participants With Highest Level of TEAEs Severity|Severity of AEs was evaluated based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 as follow: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (life-threatening); Grade 5 (fatal).|Baseline up to Cycle 27 Day 45|The ASat population included all enrolled participants who received at least 1 dose of TAK-117.|||participants|||Number
2675240|NCT01449370|Primary|Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Death, Adverse Events (AEs) Leading to Discontinuation of Study Drug, and DLTs in Cycle 1||Baseline up to Cycle 27 Day 45|The ASat population included all enrolled participants who received at least 1 dose of TAK-117.|||participants|||Number
2675241|NCT01449370|Primary|Maximum Tolerated Dose (MTD) of TAK-117|MTD is highest dose level of TAK-117 at which no more than 1 out of 6 participants had a dose limiting toxicity (DLT) during first cycle. DLT was any 1 of following events occurring within first 21 days of Cycle 1 of TAK-117 administration, Grade 2: fasting hyperglycemia for >14 days. Grade 3: nausea and/or vomiting/diarrhea for >7 days; rash for >7 days; thrombocytopenia with bleeding; fasting hyperglycemia for >24 hours(hr). Grade >=3:nonhematologic toxicity considered clinically significant by investigator. Grade 4:neutropenia (absolute neutrophil count <=0.5*10^9per liter[/L]) for >7 days in absence of growth factor support; neutropenia of any duration accompanied with fever >=38.5 degree Celsius and/or systemic infection. Grade >=4:hematologic toxicity. Inability to administer at least 75% of planned doses of TAK-117 within Cycle 1 due to its related toxicity;Any clinically significant occurrence that investigators and sponsor agreed would place participants at undue safety risk.|Baseline up to Cycle 1 Day 21|The ASat population included all enrolled participants who received at least 1 dose of TAK-117.|||mg|||Number
2675242|NCT01449305|Other Pre-specified|Medicine Administration for Pain Relief During Study Period|Continue taking pharmacological pain relief if required for subjects was allowed during study period, and it had been recorded.|first menstrual cycle, second menstrual cycle and third menstrual cycle|It was analyzed based on the PP population.|||percentage of participants|||Number
2675352|NCT01447433|Secondary|Change in Blood Pressure|Systolic and diastolic blood pressures were measured in the left arm at heart level of subjects seated for a minimum of 5 minutes using mercurial sphygmomanometer.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||mm Hg||Standard Deviation|Mean
2675243|NCT01449305|Primary|The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline|The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain).|baseline, first menstrual cycle, second menstrual cycle and third menstrual cycle|Subjects were asked to use the VAS scoring system to record, on a provided sheet, their experienced menstrual pain level daily during menstrual bleeding for a total of three consecutive menstrual cycles in house. Primary objective was analyzed based on the Per-protocol (PP) population.|||scores||Standard Deviation|Mean
2675244|NCT01449279|Secondary|Progression-free Survival (PFS)|Median time to progression-free survival (PFS) was calculated using the Kaplan-Meier algorithm|2 to 4 weeks after last ipilimumab and then every 3 months until disease progression.|All subject who did not have SAEs during treatment.|||weeks||95% Confidence Interval|Median
2675245|NCT01449279|Secondary|Median Time to Complete Response or Partial Response|Time from the first dose of ipilimumab to the first tumor measurement showing either a complete or partial response to therapy.|2 to 4 weeks after last ipilimumab and then every 3 months until disease progression.|All patients who had either a complete response or partial response.|||weeks||95% Confidence Interval|Median
2675246|NCT01449279|Secondary|Stable Disease|Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements|2 to 4 weeks after last ipilimumab and then every 3 months until disease progression.|All patients who did not have SAEs during treatment and did not reach complete response or partial response.|||weeks||Full Range|Median
2675247|NCT01449279|Secondary|Duration of Partial Response.|Length of time between first dose of ipilimumab and a partial response according to RECIST v1.1 (see above) and immune response criteria|2 to 4 weeks after last ipilimumab and then every 3 months until disease progression.|all patients that did not have SAEs during treatment and did not have complete response.|||weeks||Full Range|Median
2675248|NCT01449279|Secondary|Duration of Complete Response|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented.|2 to 4 weeks after last ipilimumab dose then every 3 months +/- 2 weeks until progression of disease|all subjects|||weeks||Full Range|Median
2675249|NCT01449279|Secondary|Overall Survival|Median time to overall survival was calculated using the Kaplan-Meier algorithm.|2 to 4 weeks after last ipilimumab dose then every 3 months +/- 2 weeks until progression of disease|All subjects|||weeks||Full Range|Median
2675250|NCT01449279|Secondary|Response Rate|"Compare tumor response rate and duration of response at unirradiated sites in patients with Stage IV melanoma with historical controls.~Response assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by physical measurement; magnetic resonance imaging (MRI); computed tomography (CT), positron emission tomography (PET)-CT; and/or X-rays:~Complete Response (CR) = Disappearance of all target lesions~Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions~Overall Response (OR) = CR + PR"|2 to 4 weeks after last ipilimumab dose then every 3 months +/- 2 weeks until progression of disease|All subjects.|||Participants|||Count of Participants
2675251|NCT01449279|Primary|Safety Measurement - Percentage of Patients Experiencing Serious Adverse Events (SAEs) in the First 4 Months of Treatment.|Serious adverse events (SAEs) defined as untoward medical occurrence that at any dose: results in death, is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires in subject hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event (defined as a medical event(s) that may not be immediately life-threatening or result in death or hospitalization but, may jeopardize the subject or may require intervention to prevent one of the other serious outcomes listed in the definition above.)|4 months|All subjects.|||Participants|||Count of Participants
2675252|NCT01449266|Post-Hoc|Percent Change in Gadolinium Serum Concentration 4h After Third Hemodialysis Session, Estimated From Subjects With Concentration Data Above the Limit of Detection|The evaluation of the decrease in seric concentration of gadolinium, 4h after the third hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem®. The percent change of gadolinium concentration was estimated from the concentration of gadolinium after Dotarem® injection. Only subjects with gadolinium concentration above the lower limit of detection were kept for analysis.|Dotarem® dialysability assessed 4h after third hemodialysis session which took place 4 days after Dotarem® administration|8 subjects had a gadolinium concentration <LLQ after third hemodialysis session|||percent change in Gd concentration||Full Range|Geometric Mean
2675253|NCT01449266|Post-Hoc|Percent Change in Gadolinium Serum Concentration 4h After Second Hemodialysis Session, Estimated From Subjects With Concentration Data Above the Limit of Detection|Evaluation of the decrease in seric concentration of gadolinium, 4h after the second hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem®. The percent change of gadolinium concentration was estimated from the concentration of gadolinium after Dotarem® injection. Only subjects with gadolinium concentration above the lower limit of quantification (LLQ) were kept for analysis.|Dotarem® dialysability assessed 4h after second hemodialysis session which took place 2 days after Dotarem® administration|3 subjects had a gadolinium concentration <LLQ after the second hemodialysis session|||Percent change in Gd concentration||Full Range|Geometric Mean
2675254|NCT01449266|Secondary|Safety of Dotarem® in Dialysed Patients Evaluated by the Number of Patients Experiencing Adverse Events.|To evaluate the biological and clinical safety of Dotarem® by assessing vital signs, biological parameters, injection-site tolerance, through a 4-day post injection follow-up, adverse events through a 3-week post injection period and serious adverse events through a 3-month post injection period.|Safety assessed from patients inclusion until the last follow-up visit 3 months after Dotarem® administration||||participants|||Number
2675353|NCT01447433|Secondary|Change in Waist, Abdominal and Hip Circumference|Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||cm||Standard Deviation|Mean
2675255|NCT01449266|Primary|Dialysability of Dotarem® in Dialysed Patients|To evaluate the decrease in seric concentration of gadolinium, after each hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem® . The percent change of gadolinium concentration is calculated by estimating the amount of serum gadolinium before and after each hemodialysis session. Calculations are performed only for subjects with concentration above the lower limit of quantification (LLQ)|Dotarem® dialysability assessed up to 4 days after Dotarem® administration|After second hemodialysis, 3 subjects had Gd concentration<LLQ and are not included in the analysis; after third hemodialysis, 8 subjects had Gd concentration<LLQ and are not included in the analysis|||percent change in Gd concentration||Full Range|Geometric Mean
2675256|NCT01449240|Secondary|Levels of GAG in Urine|The levels of GAG (including sulfated DS/HS oligosaccharides) in urine were determined by the Blyscan sulfated GAG assay kit. The concentration of GAG in urine was normalized to the urine creatinine value and reported as mg GAG/mmol creatinine.|Day 1|Pharmacodynamic Population: All patients for which an evaluable CSF sample was collected. Urinary GAG was not measured in 2 patients: 1 pediatric patient who provided a retrospective CSF sample only (no urine sample was collected) and 1 adult patient whose CSF sample was not considered evaluable and therefore their urinary GAG was not measured.|||mg GAG/mmol Creatinine||95% Confidence Interval|Mean
2675257|NCT01449240|Primary|Levels of Total Glycosaminoglycan (GAG) in CSF|The concentration of total GAG, including heparan sulfate (HS) and dermatan sulfate (DS) oligosaccharides, in CSF was measured using an enzymatic assay.|Day 1|Pharmacodynamic Population: All patients for which an evaluable CSF sample was collected. This included a pediatric patient who was consented to provide a retrospective CSF sample.|||ng/mL||95% Confidence Interval|Mean
2675258|NCT01449006|Secondary|Change in MRS Cerebral Metabolite Ratios in Frontal White Matter|Change in major cerebral metabolites in the frontal white matter, as measured by 1H-Magnetic Resonance Spectroscopy (MRS), between baseline and 12-months. Spectra were acquired on a Phillips Achieva 3T MRI scanner using point-resolved spectroscopy (PRESS) sequence with short TE. jMRUI/AMARES algorithm was used to process spectra. Metabolite ratios were calculated for the following metabolites: N-acetyl aspartate (NAA), choline (Cho), creatine (Cr), myo-inositol (mIo), glutamate/glutamine complex (Glx), in relation to internal H2O as standard.|Baseline and 12 months|The analysis included all randomized participants who were included in the primary analysis aside from n=1 control who did not attend MRI appointment at 12-months.|||ratio||Standard Error|Least Squares Mean
2675259|NCT01449006|Secondary|Change in MRS Cerebral Metabolite Ratios in Basal Ganglia|Change in major cerebral metabolites in the basal ganglia, as measured by 1H-Magnetic Resonance Spectroscopy (MRS), between baseline and 12-months. Spectra were acquired on a Phillips Achieva 3T MRI scanner using point-resolved spectroscopy (PRESS) sequence with short echot time (TE). jMRUI/AMARES algorithm was used to process spectra. Metabolite ratios were calculated for the following metabolites: N-acetyl aspartate (NAA), choline (Cho), creatine (Cr), myo-inositol (mIo), in relation to internal water (H20) as standard.|Baseline and 12 months|The analysis included all randomized participants who were included in the primary analysis aside from n=1 control who did not attend MRI appointment at 12-months.|||ratio||Standard Error|Least Squares Mean
2675260|NCT01449006|Secondary|Change in CSF Neopterin Concentration|Change in concentration of the CSF neuroinflammatory marker neopterin (measured in nmol/L) from baseline to 12-months.|Baseline and 12-months|The analysis included all randomized participants who were included in the primary analysis aside from n=1 control and n=2 maraviroc who did not provide a CSF sample at 12-months.|||nmol/L||Standard Error|Least Squares Mean
2675261|NCT01449006|Primary|Change in Neurocognitive Functioning|Change in overall neurocognitive performance, defined as a global neurocognitive z-score, over the study time-period (baseline, 6-months, 12-months). To derive this score, 1) raw scores obtained from a 5-domain brief neurocognitive battery were converted to age-corrected z-scores (M=0, SD=1) and 2) the set of individual subtest z-scores were averaged to generate a single composite (global) z-score for each subject. Lower (negative) scores therefore indicate greater levels of cognitive impairment.|Baseline, 6-months and 12-months|Modified intent-to-treat analysis. All randomized participants were included except for n=2 controls with baseline data only (1 lost to follow-up, 1 withdrew before 6-months) and n=1 control where a protocol violation was noted (randomized without conclusive evidence of neurocognitive impairment - see participant flow section).|||Global Neurocognitive Z-Score||Standard Error|Least Squares Mean
2675262|NCT01448850|Secondary|Number of Participants Exhibiting Anti-Drug Antibodies for MEDI8968 at Any Visit|Anti-drug antibodies for MEDI8968 were analyzed for participants who received placebo or MEDI8968 as per planned analysis.|Day 1 up to Week 69|Immunogenicity (IM) population included all participants who were randomized, received at least one dose of investigational product, and had at least one post-dose serum sample for IM testing.|||participants|||Number
2675263|NCT01448850|Secondary|Observed Serum Concentrations of MEDI8968||Pre-dose (Baseline), Post-dose on Week 53|PK population included all participants who were randomized, received at least one dose of investigational product, and had at least one post-dose serum concentration.|||nanogram per milliliters (ng/mL)||Standard Deviation|Mean
2675264|NCT01448850|Secondary|Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Week 69 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs reported below included both SAEs and non-serious AEs.|Day 1 up to Week 69|Safety population included all participants who were randomized and received at least one dose of investigational product.|||participants|||Number
2675273|NCT01448824|Secondary|Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax) of LY2484595|The times of maximum observed plasma concentrations (tmax) of LY2484595 after a single dose and after once daily (QD) dosing for 14 consecutive days are reported.|Part 1, Periods 1 and 2, Day 1: Predose, 1, 2, 3, 4, 6, 8, 12, and 24 Hours Postdose; Day 14 through Day 21: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 Hours Post Dose|Participants who received at least 1 dose of study drug and had evaluable LY2484595 concentration data.|||Hours (h)||Full Range|Median
2675265|NCT01448850|Secondary|Percentage of Participants With Improvement in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score|The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD). Negative change score signifies improvement compared to baseline. Number of participants with improvement in BODE score compared to baseline were reported.|Baseline and Week 53|The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'N' signifies those participants evaluable for this measure.|||percentage of participants|||Number
2675266|NCT01448850|Secondary|Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score at Week 53|The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test. The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe). BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD).|Baseline and Week 53|The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'N' signifies those participants evaluable for this measure.|||units on a scale||Standard Error|Mean
2675267|NCT01448850|Secondary|Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score|The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status. A 4-point change in total score demonstrates a clinically meaningful change, while an 8-point change and a 12-point change are interpreted as a moderate and large change in health status, respectively.|Week 53|The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||percentage of participants|||Number
2675268|NCT01448850|Secondary|Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Subscales Scores at Week 53|The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease). Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100. The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status.|Baseline and Week 53|The mITT population included all participants who were randomized into the study and received any investigational product. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.|||units on scale||Standard Error|Mean
2675269|NCT01448850|Secondary|Time to First Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|Time to first worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Mild exacerbations require treatment with an increase in usual therapy, e.g., increase use of short acting bronchodilators. Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization.|Day 1 up to 393|The mITT population included all participants who were randomized into the study and received any investigational product.|||days||Inter-Quartile Range|Median
2675270|NCT01448850|Secondary|Mean Rate of Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.|Day 1 up to 393|The mITT population included all participants who were randomized into the study and received any investigational product.|||AECOPD events/year||90% Confidence Interval|Mean
2675271|NCT01448850|Primary|Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)|An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days. The severity of an AECOPD is defined as: Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics. Severe exacerbations require hospitalization. The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations. Mean exacerbations were presented as number of exacerbations/year.|Day 1 up to 393|Modified intent-to-treat (mITT) population included all participants who were randomized into the study and received any investigational product.|||AECOPD events/year||90% Confidence Interval|Mean
2675272|NCT01448824|Secondary|Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2484595|Exposure to LY2484595 in terms of the area under the concentration-time curves (AUC) after a single dose and after once daily (QD) dosing for 14 consecutive days are reported.|Part 1, Periods 1 and 2, Day 1: Predose, 1, 2, 3, 4, 6, 8, 12, and 24 Hours Postdose; Day 14 through Day 21: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 Hours Post Dose|All participants who received at least 1 dose of LY2484595 and had at least 3 consecutive plasma LY2484595 concentrations above the lower limit of quantification with at least 1 of these concentrations following the maximum observed plasma concentration (Cmax).|||Nanograms * hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2675274|NCT01448824|Secondary|Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2484595|The maximum observed plasma concentrations (Cmax) of LY2484595 after a single dose and after once daily (QD) dosing for 14 consecutive days are reported.|Part 1, Periods 1 and 2, Day 1: Predose, 1, 2, 3, 4, 6, 8, 12, and 24 Hours Postdose; Day 14 through Day 21: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 Hours Post Dose|Participants who received at least 1 dose of LY2484595 and had evaluable LY2484595 concentration data.|||Nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2675275|NCT01448824|Secondary|Pharmacodynamics: Change From Baseline to Day 21 in High-density Lipoprotein Cholesterol (HDL-C), Low-density Lipoprotein Cholesterol (LDL-C), and Triglycerides (TG)||Day 1 (Baseline) and Day 21|Participants who received at least 1 dose of LY2484595 or placebo during Period 1 and had evaluable pharmacodynamic (HDL-C, LDL-C, TG) data.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2675276|NCT01448824|Secondary|Pharmacodynamics: Change From Baseline to Day 21 in Cholesteryl Ester Transfer Protein (CETP) Activity||Day 1 (Baseline) and Day 21|Participants who received at least 1 dose of LY2484595 or placebo and had evaluable pharmacodynamic (CETP) data.|||Picomoles per milliliters per minute||Standard Deviation|Mean
2675277|NCT01448824|Primary|Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2484595|The geometric least squares (LS) means of area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞) of LY2484595 following administration of LY2484595 alone and with ketoconazole are reported. Least squares means were calculated from an analysis of variance (ANOVA) model with a fixed effect for treatment and a random effect for participant. The LS means for each treatment and the 90% confidence intervals (CI) for the difference in means were back transformed from the log scale to provide estimates of the geometric means and 90% CIs for the ratio of the geometric means (LY2484595 coadministered with ketoconazole and LY2484595 alone).|Part 2, Period 1, Day 1 through Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post Dose; Period 2, Day 5 through Day 15: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 Hours Post Dose|Participants who received at least 1 dose of LY2484595 and had at least 3 consecutive plasma LY2484595 concentrations above the lower limit of quantification with at least 1 of these concentrations following the maximum observed plasma concentration (Cmax).|||Nanograms * hours per milliliter||90% Confidence Interval|Geometric Mean
2675278|NCT01448824|Primary|Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax) of LY2484595|The median times to maximum observed plasma concentration (Tmax) of LY2484595 following administration of LY2484595 alone and with ketoconazole are reported.|Part 2, Period 1, Day 1 through Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post Dose; Period 2, Day 5 through Day 15: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 Hours Post Dose|Participants who received at least 1 dose of LY2484595 and had evaluable LY2484595 concentration data.|||Hours (h)||Full Range|Median
2675279|NCT01448824|Primary|Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2484595|The geometric least squares (LS) means for the maximum observed plasma concentration (Cmax) of LY2484595 following administration of LY2484595 alone and with ketoconazole are reported. Least squares means were calculated from an analysis of variance (ANOVA) model with a fixed effect for treatment and a random effect for participant. The LS means for each treatment and the 90% confidence intervals (CI) for the difference in means were back transformed from the log scale to provide estimates of the geometric means and 90% CIs for the ratio of the geometric means (LY2484595 coadministered with ketoconazole and LY2484595 alone).|Part 2, Period 1, Day 1 through Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post Dose; Period 2, Day 5 through Day 15: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 Hours Post Dose|Participants who received at least 1 dose of LY2484595 and had evaluable LY2484595 concentration data.|||Nanograms per milliliter (ng/mL)||90% Confidence Interval|Least Squares Mean
2675280|NCT01448824|Primary|Part 1: Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs|The number of participants with 1 or more AEs is summarized cumulatively. In addition, the number of participants with any serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.|Part 1: Baseline through ≥14 days after last dose of study drug (≥Day 28)|All participants who received at least 1 dose of study drug.|||Participants|||Number
2675281|NCT01448707|Secondary|Number of Participants Reporting Resistance Mutations With Confirmed Virologic Failure Who Have HIV RNA >400 Copies/mL and Genotype Resistance Results|The viral genotype of participants treated with DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks. Genotypic resistance (number of resistance mutations) at any time point when a participant had a confirmed plasma VL >400 copies/mL after randomization was performed per treatment group for the ITT population. Results were summarized based on individual treatment received: Darunavir resistance mutations, non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations, nucleoside reverse transcriptase inhibitor (NRTI) mutations, protease inhibitor (PI) resistance mutations, PR mutations, RT mutations, extended NNRTI mutations, primary PI mutations.|Over 48 and 96 Weeks|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.|||Participants|||Number
2675282|NCT01448707|Secondary|Number of Participants Reporting Treatment-Emergent Phenotypic Drug Resistance|The loss of treatment options of DRV/rtv monotherapy versus triple therapy containing DRV/rtv at Weeks 48 and 96, as defined by treatment-emergent phenotypic drug resistance. Drug resistance is classified as: 1) Confirmed HIV RNA >= 400 copies/mL, 2) Post-baseline phenotypic data and 3) Phenotypic resistance to any of the drug classes (NRTI, NNRTI, or PI).|At Weeks 48 and 96|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.|||Participants|||Number
2675283|NCT01448707|Secondary|Time to Loss of Virologic Response|Time (in days) it takes to show loss of response per time to loss of virologic response (TLOVR) algorithm: confirmed HIV-1 RNA >= 50 copies/mL or premature discontinuation.|Baseline up to Week 96 or early withdrawal|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.|||Days||Full Range|Median
2675284|NCT01448707|Secondary|Change From Baseline in Global Neurocognitive Performance z-Score|Change in neurocognitive function of DRV/rtv monotherapy versus triple therapy containing DRV/rtv over 48 and 96 weeks. Neurocognitive function will be measured by Hopkins Verbal Learning Test (verbal learning and memory), Colour Trail Test (psychomotor speed and cognitive flexibility) and Grooved Pegboard Test (psychomotor speed and fine motor function). Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP).|Baseline, Week 48 and 96|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.|||Units on a Scale||Standard Error|Mean
2675285|NCT01448707|Secondary|Virologic Response (FDA Snapshot, Switch Included)|The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/milliliters [mL] after 48 and 96 weeks of follow-up after switching to DRV/ritonavir(rtv) monotherapy versus triple therapy containing DRV/rtv. Switch included is defined as all participants who discontinued randomized medication were followed up on their subsequent treatment.|Week 48 and 96|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.|||Percentage of Participants|||Number
2675286|NCT01448707|Secondary|Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)|The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/milliliters [mL] after 96 weeks of follow-up after switching to DRV/ritonavir(rtv) monotherapy versus triple therapy containing DRV/rtv. Switch = Failure is defined as switch in background nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) not permitted by the trial protocol.|Week 96|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.|||Percentage of Participants|||Number
2675287|NCT01448707|Primary|Virologic Response (Food Drug and Administration [FDA] Snapshot, Switch = Failure)|The percentage of participants who have plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels <50 copies/milliliters [mL] after 48 weeks of follow-up. Switch = Failure is defined as switch in background nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) not permitted by the trial protocol or plasma HIV-1 RNA assessment closest to target date of the analysis time point window (44-52 weeks) and next/confirmation of Plasma HIV-1 RNA in the analysis time point window above the threshold or discontinuation for any other reason.|Week 48|The intent-to-treat (ITT) population is the set of all participants who were randomized and who took at least one dose of study medication in the treatment phase.|||Percentage of Participants|||Number
2675288|NCT01448616|Secondary|Asymptomatic Shedding (Shedding on Days Without Genital Lesions)|"Within person changes in shedding on days without lesions between the lead-in (observational) phase and the study drug (treatment) phase. Each arm is evaluated separately and no inter arm comparisons are made.~We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment."|Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase|All randomized participants are included in ITT analysis. Per protocol analysis includes persons receiving 30 or more days of study drug with >90% adherence as documented by returned product counts.|||% days with asymptomatic shedding||95% Confidence Interval|Number
2675289|NCT01448616|Secondary|Genital Lesion Rate|"The within person change in proportion of days with lesions between the lead-in (observational) and study drug (treatment) phase for each arm separately. No between arm comparisons were performed. We include intent to treat with all randomized participants as well as per protocol (persons receiving study drug for at least 30 days with 90% or better reported compliance per returned product counts).~We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment."|Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase||||percentage of days with lesions (%)||95% Confidence Interval|Number
2675290|NCT01448616|Secondary|Within-person Changes in Log-copy Numbers of HSV|"The within-person changes in mean log-copy numbers of HSV shed during treatment phase (oral TDF, vaginal TFV, or double placebo) compared with the lead-in (observation) phase in the same participants. Each treatment arm is analyzed separately without comparison between arms.~We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment."|Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase|Analysis is within person changes such that the observational group contributed to analyses of those persons in each treatment randomization group|||log-copy number of HSV DNA shed||95% Confidence Interval|Mean
2675291|NCT01448616|Primary|HSV Shedding Rate in Those Receiving Oral TDF, Vaginal TFV, or Double Placebo|The within-person changes in rate of HSV shedding during study drug administration (treatment phase) compared with the rate of HSV shedding during lead-in observation phase in the same participants. We evaluated only weeks 2-5 of HSV shedding during the treatment phase in comparison with the 4 weeks of the lead-in phase. We excluded the first week of samples from the treatment phase in order to allow for physiologic run-in of the treatment. This is analyzed separately for each treatment arm and not compared between arms.|Comparison of 4 weeks of treatment phase with 4 weeks of lead-in phase|This includes intent to treat, ( all randomized participants) and per-protocol analyses (persons receiving 30 or more days of treatment with >90% compliance as recorded by returned product counts)|||percentage of swabs positive (%)||95% Confidence Interval|Number
2675292|NCT01448525|Secondary|Percentage of Participants With at Least a 1-Grade Increase in the Global Eyelash Assessment (GEA) Score|The investigator evaluated the patient's overall eyelash prominence using the 4-point GEA scale: 1=minimal (worst), 2=moderate, 3=marked or 4=very marked (best). An at least a 1-grade increase in GEA score indicated improvement.|Baseline, Week 16|Intent to treat population included all randomized participants who had at least 1 post-baseline efficacy assessment.|||Percentage of participants|||Number
2675319|NCT01447719|Other Pre-specified|Individual Reader Results (Autopsy Within 1 Year of Scan)|Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 28 positive and 18 negative scans based on histopathology at autopsy.|at autopsy within 12 months of florbetapir PET scan|Includes only those subjects with time from scan to autopsy less than one year.|||florbetapir PET scans|||Number
2675293|NCT01448525|Primary|Percentage of Participants Who Are Satisfied or Very Satisfied With Their Eyelashes Overall|"Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: Overall, how satisfied are you with your eyelashes? using a 5-point scale: -2=very unsatisfied (worst), -1=unsatisfied, 0=neutral, 1=satisfied or 2=very satisfied (best). The percentage of participants who rated their satisfaction as 1=satisfied or 2=very satisfied at Week 16 is reported."|Week 16|Intent to treat population included all randomized participants who had at least 1 post-baseline efficacy assessment.|||Percentage of participants|||Number
2675294|NCT01448486|Secondary|Cerebrospinal Fluid|To determine if there is improvement in CSF neopterin concentrations with the addition of Raltegravir.|Baseline and 12 months|Study was terminated prematurely with an incomplete study dataset before any meaningful analyses of the data could be conducted. CSF was not collected at 12 months for n=1 raltegravir and n=1 control who refused lumbar puncture.|||nmol/L||Standard Error|Mean
2675295|NCT01448486|Primary|Neurocognitive Function|Change in overall neurocognitive performance, defined as a global neurocognitive z-score, over the study time-period (baseline, 6-months, 12-months). To derive this score, 1) raw scores obtained from a 5-domain brief neurocognitive battery were converted to age-corrected z-scores (M=0, SD=1) and 2) the set of individual subtest z-scores were averaged to generate a single composite (global) z-score for each subject. Lower (negative) scores therefore indicate greater levels of cognitive impairment.|Baseline, 6 months and 12 months|Study was terminated prematurely with an incomplete study dataset any before any meaningful statistical analysis of the data (including change over the study time-points) could be performed.|||Global Neurocognitive Z-Score||Standard Error|Mean
2675296|NCT01448356|Secondary|Tear Film Break up Time|After instillation of fluorescein, the participant will then be asked to open the eyes, look ahead at the observer's forehead and not blink for as long as possible. The break up time is defined as the time between the lid opening and the first appearance of any dry spot on the cornea. The participant will be requested to close his eyes for few seconds and the procedure will be repeated for the left eye.|20 minutes after the required temperature and humidity in the chamber is achieved||||seconds||95% Confidence Interval|Mean
2675297|NCT01448356|Primary|Tear Evaporation Rate|The rate of tear evaporation is measured by the use of ocular thermography. For each subject,his/her ocular surface temperature will be recorded twice, one for each eye. The subject at first rests his/her chin on a chin rest, with his/her forehead lean against a metal frame (which is part of the chin rest). Then the recording starts lasting approximately 20seconds for each eye. While recording, the subject needs to look straight into the lens, but can blink naturally. After this, the recording data will be analyzed to derive the evaporation rate using a mathematical model.|20 minutes after the required temperature and humidity in the chamber is achieved||||Watt/meter^2||95% Confidence Interval|Mean
2675298|NCT01448213|Secondary|Number of Eyes With Intraocular Pressure (IOP) Elevation|Absolute IOP greater than or equal to 24 mm Hg or a relative increase of 10 mm Hg over the baseline preoperative reading.|one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK||||eyes|Participants||Number
2675299|NCT01448213|Primary|Number of Eyes With Immunologic Graft Rejection Episodes||Within 1 year||||eyes|Participants||Number
2675300|NCT01448057|Secondary|Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms|Subject will assess Nasal and non Nasal symptoms using a 100 mm Visual Analog Scale for each symptom, 0=no symptoms 100= the worst possible symptoms|Day 3|In the combination product arm 11 subjects had missing assessment and 5 subject in the paracetamol arm|||mm||Standard Deviation|Mean
2675301|NCT01448057|Primary|Physician Global Evaluation of Effectiveness on Nasal Symptoms|"The Physician will measure the reduction of Nasal Symptoms (Nasal Congestion, Sneezing, and Rhinorrhea) on day 2.~Range from 1 to 5 where 1 is excellent and 5 is bad :~1 = excellent : 75% to 100% remission of signs and symptoms 5 = bad : exacerbation of nasal symptoms"|Day 2|In the combination product arm 8 subjects had missing assessment and 1 subject in the paracetamol arm|||score on a scale||Standard Deviation|Mean
2675302|NCT01448044|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation.|From Day 1 (start of study treatment) up to Follow-up Week 4|Analysis was performed on all treated participants.|||participants|||Number
2675303|NCT01448044|Secondary|Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene|Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR12 and SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 12 and Week 24 respectively.|Post Treatment Weeks 12, 24|For SVR12; analysis was performed by backward imputation method, For SVR24: analysis was performed in Modified ITT population.|||Percentage of participants|||Number
2675304|NCT01448044|Secondary|Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels|Participants who achieved HCV RNA undetectable ie, 10 international units per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.|Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12, End of treatment (EOT), Post treatment Week 24, Post treatment Week 48|The analysis was performed in modified ITT population.|||Percentage of participants||95% Confidence Interval|Number
2675305|NCT01448044|Secondary|Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)|Participants who achieved HCV RNA levels below LLOQ ie, 25 international unit per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.|Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12; End of treatment (EOT); Post treatment Week 24; Post treatment Week 48|The analysis was performed in modified ITT population.|||Percentage of participants||95% Confidence Interval|Number
2675320|NCT01447719|Other Pre-specified|Individual Reader Results (All Scans With Autopsy)|Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 39 positive and 20 negative scans based on histopathology at autopsy.|at autopsy within 24 months of florbetapir PET scan||||florbetapir PET scans|||Number
2675306|NCT01448044|Primary|Percentage of Participants With 12 Week Sustained Virologic Response (SVR12)|Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels < lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12.|Week 12 (Follow-up period)|The analysis was performed in modified Intent to treat population (ITT), defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. Missing values were imputed using backward imputation technique.|||Percentage of participants||95% Confidence Interval|Number
2675307|NCT01447927|Secondary|Overall Adverse Event Rates|"Number of patients that experienced adverse events (grade 1 or above) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v. 4.0.~The data reported in the table include only the commonly occurring adverse events (3 or more events)."|Up to 30 days||||participants|||Number
2675308|NCT01447927|Primary|Percent Change in Median pS6K1 Immunostaining Among Participants With Barrett Esophagus|The percent change in pS6K1 was calculated as month 3 pS6k1 values minus baseline pS6k1 values, then divide by baseline pS6k1 values and multiply by 100.|Baseline to 3 months|Participants were considered evaluable for primary endpoint if pS6K1 data were available from both the pre- and post-intervention evaluations based on the intent-to-treat principle.|||percentage of change||Full Range|Median
2675309|NCT01447914|Post-Hoc|Cycles of Tivantinib Treatment Administered|Number of treatment cycles completed by study participants.|From start of participant treatment to completion or disease progression; assessed up to 16 months|No participants responded to the therapy and no analyses were done|||number of treatment cycles||Full Range|Mean
2675310|NCT01447914|Other Pre-specified|Progression-free Survival (PFS)|Kaplan and Meier product limit methods will be used to estimate the median PFS with 95% confidence intervals. Furthermore, the univariate and multivariate Cox proportional hazards regression model will be used to identify prognostic factors for PFS.|From start of the treatment to disease progression or death (regardless of cause of death), whichever comes first, assessed up to 30 days|No participants responded to the therapy and no analyses was done.||||||
2675311|NCT01447914|Other Pre-specified|Duration of Response|Kaplan and Meier product limit methods will be used to estimate the DOR with 95% confidence intervals.|From first observation of partial response to the time of disease progression, assessed up to 30 days|No participants responded to the therapy and no analyses were done||||||
2675312|NCT01447914|Secondary|Time to Next Treatment (TTNT)|Kaplan and Meier product limit methods will be used to estimate the TTNT with 95% confidence intervals.|From registration on trial to next treatment or death due to any cause, whichever comes first||||number of months||95% Confidence Interval|Median
2675313|NCT01447914|Primary|Toxicities of Single Agent Tivantinib: Grade 3 Nonhematologic or Grade 4 Hematologic Toxicities According to the Common Terminology Criteria for Adverse Events (CTCAE), Version 4|Toxicities with a grade 3 nonhematologic or grade 4 hematologic toxicities according to CTCAE, version 4. Grade 3 and estimated with a 95% credible interval. Summary statistics will be provided for continuous variables.|Up to 30 days||||Participants|||Count of Participants
2675314|NCT01447914|Primary|Overall Response Rate (ORR)|ORR using International Myeloma Working Group Response Criteria, achieve at least a partial response (PR) or better: Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR): CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90%; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 hour; Stable Disease (SD): Not CR, VGPR, PR or progressive disease; Progressive Disease (PD):>25% from lowest value Serum and/or Urine M-component, new lesions or soft tissue plasmacytomas, or hypercalcemia.|Up to 30 days|Proportion of participants reported on an intent-to-treat basis.|||participants|||Number
2675315|NCT01447888|Secondary|Pain Management Improvement at 24 Hours After the Recovery Period|We will be assessing if the intervention improved postoperative pain management during the first 24 hours after the recovery period (first 4 hours postoperatively) as compared to the non-intervention group. Measures that will be used to assess success: Verbal pain scores, opioid consumption (doses and frequency), and vital signs. Verbal pain scores were reported using the Wong-Baker FACES pain rating scale which ranges from 0 (no hurt) to 10 (hurts worst). Higher numerical scores on the scale indicate more pain, thus a worse outcome.|24 hours after the recovery period||||score on a scale||Standard Deviation|Mean
2675316|NCT01447888|Primary|Immediate Postoperative Pain Control|We will be assessing if the intervention improves immediate (4 hours) postoperative pain control as compared to the non-intervention group. Measures that will be used to assess immediate post-operative pain include: Verbal pain scores, opioid consumption, and vital signs. Verbal pain scores were reported using the Wong-Baker FACES pain rating scale which ranges from 0 (no hurt) to 10 (hurts worst). Higher numerical scores on the scale indicate more pain, thus a worse outcome.|4 hours post surgery||||score on a scale||Standard Deviation|Mean
2675317|NCT01447849|Secondary|Change in Viscoelasticity of Gastric Secretion in Controls and Patients With Chronic Constipation.|The viscoelasticity of gastric mucus(centipoises) was measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator).|Measured after 1 week of lubiprostone therapy and compared to 1 week of placebo with 1 week of washout in between.|To provide 0.80 statistical power for detection of significance.|||Centipoises||Standard Error|Mean
2675318|NCT01447849|Primary|Change of Mucus and Mucin Secretion in Patients With Chronic Constipation and in Controls.|The rate of mucus and mucin secretion(mg/hr) will be measured in gastric juice aspirated in basal conditions and during stimulation with pentagastrin after 1 week of therapy with lubiprostone (Active Comparator) and compared with 1 week of placebo administration (Placebo Comparator).|Measured after 1 week of lubiprostone and 1 week of placebo with 1 week of washout period in between.|Number of participants was calculated to provide statistical power of 0.80 for detection of significance.|||mg/hour||Standard Error|Mean
2675322|NCT01447719|Secondary|Specificity Analysis in Subjects With Autopsy Within 1 Year of Scan|Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).|at autopsy within 12 months of florbetapir PET scan|18 of 46 subjects who died within 1 year of scan had no or sparse neuritic plaques at autopsy|||participants|||Number
2675323|NCT01447719|Secondary|Sensitivity Analysis in Subjects With Autopsy Within 1 Year of Scan|Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).|at autopsy within 12 months of florbetapir PET scan|28 of 46 subjects who died within 1 year of scan had moderate to frequent neuritic plaques at autopsy|||participants|||Number
2675324|NCT01447719|Primary|Correlation of Florbetapir-PET Image and Amyloid Plaque Density|Spearman's rank order correlation of the median visual read of the florbetapir-PET image and the amyloid plaque density assessed post-mortem by quantitative immunohistochemistry (IHC) averaged across 6 brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.|at autopsy within 24 months of florbetapir PET scan||||Correlation coefficient||95% Confidence Interval|Number
2675325|NCT01447719|Primary|Specificity Analysis in All Autopsy Population|Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).|at autopsy within 24 months of florbetapir PET scan|20 of 59 subjects from the all autopsy population had no or sparse neuritic plaques at autopsy|||participants|||Number
2675326|NCT01447719|Primary|Sensitivity Analysis in All Autopsy Population|Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD (Consortium to Establish a Registry for AD) criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).|at autopsy within 24 months of florbetapir PET scan|39 of 59 subjects from all autopsy population had moderate to frequent neuritic plaques at autopsy|||participants|||Number
2675327|NCT01447706|Post-Hoc|To Explore the Utility of an EGFR Family Receptor-ligand (Heregulin, HRG) as a Predictor of Response to MM-121 and /or Paclitaxel in Formalin Fixed (FFPE) Tumor Samples|Fresh tumor samples were obtained from patients prior to enrollment and formalin-fixed for analysis. Samples were analyzed using RNA-ISH for the expression of the biomarker, heregulin. Progression-free survival was assessed using RECIST v 1.1 to determine whether patients whose tumors express HRG have a lower PFS than those whose tumors do not express HRG, and to assess whether the addition of MM-121 to Paclitaxel can increase PFS in HRG-high patients.|Time from first dose to date of progression, the longest time frame of 3.9 years|Patients with available tissue for RNA-ISH analysis|||months PFS||95% Confidence Interval|Median
2675328|NCT01447706|Secondary|Overall Survival|To determine whether MM-121 + paclitaxel is more effective than paclitaxel alone in prolonging overall survival. This was a time-to-event analysis of time from first dose to date of death.|Time from first dose to date of death, with a median of approximately 13 months||||months||95% Confidence Interval|Median
2675329|NCT01447706|Primary|Progression Free Survival|"To determine whether MM-121 + paclitaxel was more effective than paclitaxel alone in prolonging progression-free survival in advanced ovarian cancers resistant or refractory to platinum agents. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD)."|Time from first dose to date of progression, the longest time frame of 3.9 years||||months||95% Confidence Interval|Median
2675330|NCT01447576|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.|The items on CGI-I scale are 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) was set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI improvement was compared to the participants condition at Baseline.|Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (LOCF)|Efficacy dataset had participants who received at least 1 dose of brexpiprazole and had a baseline and atleast 1 postbaseline efficacy evaluation for CGI-S. LOCF dataset included data recorded at a given visit in treatment phase or, if no observation was recorded at that visit, data carried forward from the previous visit in the Treatment Phase.|||Units on a scale||Standard Deviation|Mean
2675331|NCT01447576|Secondary|Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.|The CGI-S is a 7-point scale from 1 through 7. The items on CGI-S scale are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill participants. The score 0 (= not assessed) was set to missing.|Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (last-observation-carried-forward [LOCF])|Efficacy dataset had participants who received at least 1 dose of brexpiprazole and had a baseline and at least 1 postbaseline efficacy evaluation for CGI-S. LOCF dataset included data recorded at a given visit in treatment phase or, if no observation was recorded at that visit, data carried forward from the previous visit in the Treatment Phase.|||Units on a scale||Standard Deviation|Mean
2675354|NCT01447433|Secondary|Change in Visceral Fat Area|BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine visceral fat area.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||cm^2||Standard Deviation|Median
2675355|NCT01447433|Secondary|Change in Fat Percentage|BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine fat percentage.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||Percentage of body weight||Standard Deviation|Mean
2675332|NCT01447576|Primary|Participants With Adverse Events (AEs).|An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the physician. The severity was assessed as mild, moderate, or severe. A treament-emergent AE (TEAE) was defined as any AE that started after start of open-label brexpiprazole; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study drug.|After the Informed Consent Form (ICF) was signed, through Follow up 30 (+2) days after last visit|The primary safety dataset included all participants exposed to at least 1 dose of brexpiprazole.|||Participants|||Number
2675333|NCT01447511|Primary|Warfarin Clearance.|Warfarin enantiomer (S-warfarin and R-warfarin) clearance was measured in healthy volunteers genotyped for CYP2C9*1/*1, CYP2C9*1B/*1B, CYP2C9*1/*3, CYP2C9*2/*3 and CYP2C9*3/*3 to determine the magnitude of the warfarin-fluconazole (inhibition) and warfarin-rifampin (induction) drug interactions.|Over three (two for CYP2C9*1B/*1B participants) 12-16 day study periods.|Participants with the CYP2C9*1B/*1B haplotype did not participate in the fluconazole period (inhibition). One CYP2C9*1/*3 participant only completed the control period. One CYP2C9*2/*3 participant only completed the control and fluconazole (inhibition) study periods.|||mL/h||Standard Deviation|Mean
2675334|NCT01447446|Secondary|Percentage of Participants With Adverse Events (AE)|An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.|Up to 118 weeks|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants|||Number
2675335|NCT01447446|Secondary|Percentage of Participants With Concomitant Medical Condition at Baseline||Baseline|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants|||Number
2675336|NCT01447446|Secondary|Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA)|Participants who prolonged the treatment period from 72 weeks were not reported. Participants who discontinued their treatment as planned were included. Here, number of participant analyzed is the total number of participants who received direct-acting anti-viral (DAA).|Up to 72 weeks of treatment|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants|||Number
2675337|NCT01447446|Secondary|Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV)|Participants who prolonged the treatment period from 72 weeks were not reported.|Up to 72 weeks of treatment|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants|||Number
2675338|NCT01447446|Secondary|Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC)||Up to 118 weeks|The data for this outcome measure were not collected and analyzed because the standard of care has changed significantly since the development of the study protocol, this comparison was no longer of practical value.||||||
2675339|NCT01447446|Secondary|Duration of Overall Treatment|Duration of overall treatment was defined as the time between first and last administration of any study drug, in weeks.|Up to 118 weeks|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||Weeks||Standard Deviation|Mean
2675340|NCT01447446|Secondary|Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR)|Extended (rapid) virological response (eRVR) defined as UVR at weeks 4 and 12 for telaprevir, and as UVR at weeks 8 and 24 for boceprevir.|Up to 98 weeks|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants||95% Confidence Interval|Number
2675341|NCT01447446|Secondary|Percentage of Participants With Very Rapid Virological Response, Rapid Virological Response, Complete Early Virological Response and Partial Early Virological Response (pEVR) During First 12 Weeks|Percentage of participants with very rapid virological response (VRVR) (defined as VR/UVR by study week 2), rapid virological response (RVR) (defined as VR/UVR by study week 4, but no VRVR), complete early virological response (cEVR) (defined as VR/UVR by study week 12, but no VRVR or RVR) and partial early virological response (pEVR) (defined as a 2 log10 drop of HCV RNA by study week 12, but no VRVR, RVR or cEVR) were reported.|Up to 12 weeks|The data for all of the above mentioned virological responses were not collected and was not analyzed.||||||
2675356|NCT01447433|Secondary|Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass|BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine body fat mass, body lean mass, and visceral fat mass.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||kg||Standard Error|Mean
2675357|NCT01447433|Primary|Change in Body Weight|Weight was obtained in light clothing to the nearest 0.1kg using a digital scale 8:00am and 10:00am after an overnight fast between.|Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||kg||Standard Deviation|Mean
2675428|NCT01446250|Primary|Percentage of Participants That Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events||within 48 weeks|No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.||||||
2675342|NCT01447446|Secondary|Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions|SVR 12 and 24 rates for dual therapy participants are defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 or 24 weeks post completion of the treatment period. If a qualitative test was used, then the lower limit of detection has to be <=50 IU/mL. SVR12 and 24 rates for triple therapy participants are defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 or 24 weeks post completion of the treatment period. Here, number of participants analyzed excluded the participants with premature withdrawal due to lack of efficacy or non-safety reasons and participants without dose reductions or interruptions during the first 99 study days.|Up to first 12 weeks of treatment|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants||95% Confidence Interval|Number
2675343|NCT01447446|Secondary|Virological Breakthrough|Virological breakthrough/rebound defined as non-VR/non-UVR during the treatment period (including end of treatment) in participants with prior VR/UVR or an increase of HCV RNA by >=1 log10 during the treatment period in comparison to the lowest HCV RNA (nadir) previously measured during the treatment period in participants without VR/UVR during the treatment period. Here, Number of participants analyzed is the participants with at least 2 on-treatment HCV RNA assessments (including EoT) or 1 on-treatment HCV RNA assessment (excluding EoT) and response at EoT by backward imputation.|Up to EOT (up to 118 weeks)|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants||95% Confidence Interval|Number
2675344|NCT01447446|Secondary|Virological Relapse After End of Treatment|Virological relapse defined as non-virological response (non-VR)/non-undetectable virological response (non-UVR) at the last HCV RNA assessment during the treatment-free follow-up period in participants with VR/UVR at EOT. Here, number of participants analyzed is the participants with end of treatment response (EoT-R) who also had an HCV RNA test at least 12 weeks after EoT or whose last follow-up HCV RNA test showed non-response (HCV RNA >=50 IU/mL).|Up to 24 weeks after EOT (up to 118 weeks)|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants||95% Confidence Interval|Number
2675345|NCT01447446|Secondary|Virological Response at Various on Treatment Time Points and End of Treatment (EOT)|Virological response (VR) for dual therapy participants is defined as HCV RNA <50 IU/mL as assessed by a qualitative HCV RNA test with a lower limit of detection (LLD) <=50 IU/mL or as assessed by a quantitative test with a lower limit of quantification (LLQ) <=50 IU/mL for all time points concerned. Results of HCV RNA tests with LLD and LLQ >50 IU/mL were considered as non-response. VR for triple therapy participants is defined as undetectable HCV RNA assessed by a test with lower limit of detection <=50 IU/mL (UVR). Results of HCV RNA tests with an LLD >50 IU/mL were considered as non-response for triple therapy participants.|Week 4, 12 and End of treatment (EOT) (up to 96 weeks)|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants||95% Confidence Interval|Number
2675346|NCT01447446|Primary|Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12)|SVR12 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR12 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 weeks post completion of the treatment period.|12 weeks after end of treatment (up to 118 weeks)|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants||95% Confidence Interval|Number
2675347|NCT01447446|Primary|Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24)|SVR24 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 24 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR24 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 24 weeks post completion of the treatment period.|24 weeks after end of treatment (up to 118 weeks)|Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).|||percentage of participants||95% Confidence Interval|Number
2675348|NCT01447433|Secondary|Change in Energy Intakes||Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||kcal/d||Standard Deviation|Mean
2675349|NCT01447433|Secondary|Change in Fasting Plasma Insulin||Baseline and 12 weeks|Males were excluded from final analysis for statistical reasons.|||mIU/L||Standard Deviation|Mean
2675358|NCT01447420|Secondary|Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12|Viral load reduction at Week 4 and Week 12 relative to the Baseline (Week 0) in terms of the expression profile of IL-28b was reported. The reduction was measured according to the following ranges: < 1.0 log IU/ml; >= 1.0 and < 2.0 log IU/ml; >= 2.0 and < 3.0 log IU/ml; >= 3.0 and <4.0 log IU/ml; >= 4.0 log IU/ml. Changes in viral load are usually reported as a log change (in powers of 10). For example, a two log decrease in viral load (2 Log10) is a decrease of 10^2 or 100 times to the previously reported levels. N = number of participants, for Week 0 to Week 4 (n = 34, 68, 17) and Week 0 to Week 12 (n = 35, 69, 18) for CC, CT and TT genotypes respectively.|From Baseline (Week 0) to Week 12|The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at baseline. Participants with available data at the time of evaluation were analyzed.|||participants|||Number
2675359|NCT01447420|Secondary|Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment|Participants with sustained virological response (SVR) and development of anemia during the first month and after the first month of treatment according to the different expression profiles of IL-28B were reported.|Up to Week 72|The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at baseline.|||participants|||Number
2675360|NCT01447420|Secondary|Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression|Viral Response rate (rapid/early/end of treatment) in relation to IL28-B expression (measured by the rate of non-detection of HCV RNA at treatment Weeks 4, 12, 24 and after the End of Treatment (EOT, i.e. Week 48) based on the expression profile of IL-28B (CC, CT or TT) were reported. Rapid virologic response (RVR) was defined as undetectable HCV RNA at treatment Week 4. Partial early virological response (pEVR) was defined as positive HCV viral load, but with a >= 2 log10 international units (IU) per millilitre (mL) reduction at treatment Week 12 from Baseline (Week 0); Complete early virologic response (cEVR) was defined as undetectable HCV RNA at treatment Week 12; Virologic response at treatment Week 24 (VR 24) was defined as undetectable HCV RNA at treatment Week 24; Virologic response at end of treatment (EOT) was defined as undetectable HCV RNA at treatment Week 48; SVR at 24 weeks after end of treatment was defined as undetectable HCV RNA at 24 weeks after EOT.|Weeks 4, 12, 24, 48, 60 and 72|The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at baseline.|||participants|||Number
2675361|NCT01447420|Primary|Percentage of Participants With Incidence of Anemia|Anemia is a condition marked by a deficiency of red blood cells (RBCs) or of hemoglobin (Hb) in the blood, resulting in pallor and weariness anemia (Hb < 11 gram per decilitre (g/dL) for women and Hb < 12 g/dL for men). Incidence of anemia was calculated by dividing the number of participants who experienced the event by the number of participants in the safety population.|Up to Week 72|Safety population included all enrolled participants who received at least one dose of any study medication.|||Percentage of participants||95% Confidence Interval|Number
2675362|NCT01447420|Primary|Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression|Participants with sustained virological response (SVR) rate in relation to interleukin 28B expression were reported. SVR rate is defined as the percentage of participants with undetectable HCV Ribonucleic acid (RNA), measured at least 24 weeks after the end of treatment (48 weeks) in terms of the expression profile of Interleukin 28B (IL-28B) (CC, CT or TT) in participants with genotype 1 hepatitis C virus (HCV) chronic infection. Participants with detectable HCV RNA or without measurement at the end of the follow-up period were considered as non-responders.|At Week 72|The efficacy population included all enrolled participants who received at least one dose of any study medication, excluding one participant who took medication and had HCV RNA undetectable at Baseline (Week 0).|||Percentage of participants||95% Confidence Interval|Number
2675363|NCT01447407|Secondary|Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interleukin-17A (IL-17A)|A secondary objective is to compare the cellular immune response for Als3-specific production of IL-17A from PBMCs between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. The IL-17A cellular immune responses will be evaluated by ELISpot using approximately 200,000 PBMCs per well. A positive response was defined as a sample with greater than 20 spot forming units per 10^6 PBMCs.|Baseline, Day 7, Day 14, Day 28, Day 90/Exit||||Participants|||Count of Participants
2675364|NCT01447407|Secondary|Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interferon-gamma (IFN-g)|A secondary objective is to compare the cellular immune response for Als3-specific production of IFN-g from PBMCs between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. The IFN-g cellular immune responses will be evaluated by ELISpot using approximately 200,000 PBMCs per well. A positive response was defined as a sample with greater than 20 spot forming units per 10^6 PBMCs.|Baseline, Day 7, Day 14, Day 28, Day 90/Exit||||Participants|||Count of Participants
2675365|NCT01447407|Secondary|Immunogenicity - Cervicovaginal Wash Anti-Als3 IgA1|A secondary objective is to compare the cervicovaginal wash IgA1 immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Cervicovaginal wash IgA1 will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.|Baseline, Day 7, Day 14, Day 28, Day 90/Exit||||Titer||Standard Deviation|Geometric Mean
2675366|NCT01447407|Secondary|Immunogenicity - Cervicovaginal Wash Anti-Als3 IgG|A secondary objective is to compare the cervicovaginal wash IgG immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Cervicovaginal wash IgG will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.|Baseline, Day 7, Day 14, Day 28, Day 90/Exit||||Titer||Standard Deviation|Geometric Mean
2675476|NCT01445951|Secondary|FPG Change From Baseline to Week 24|Comparison of mean change from Baseline to Week 24 visit in fasting plasma glucose (FPG) levels (central laboratory results)|Baseline to Week 24|Full analysis set|||mg/dL||Standard Error|Least Squares Mean
2675367|NCT01447407|Secondary|Immunogenicity - Serum Anti-Als3 IgA1|A secondary objective is to compare the serum IgA1 immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Serum IgA1 will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.|Baseline, Day 7, Day 14, Day 28, Day 90/Exit||||Titer||Standard Deviation|Geometric Mean
2675368|NCT01447407|Secondary|Immunogenicity - Serum Anti-Als3 IgG|A secondary objective is to compare the serum IgG immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Serum IgG will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.|Baseline, Day 7, Day 14, Day 28, Day 90/Exit||||Titer||Standard Deviation|Geometric Mean
2675369|NCT01447407|Primary|Number of Participants With Treatment Emergent Adverse Events|The primary objective of this study is to assess the safety of a single dose of NDV-3 vaccine, administered either IM with or without alum adjuvant at one dose level or ID at a lower dose level, compared to placebo. Clinical evaluations will be assessed on each subject at selected time points up to 90 days post-vaccination.|Up to 90 days post-vaccination|All subjects completing study. Additionally, a subject in Group 4 withdrew from the study before the very last visit, so while this subject is not considered to have completed the study, immunogenicity and culture data for this subject were included.|||participants|||Number
2675370|NCT01447225|Secondary|Immunogenicity|Samples were collected to determine the presence of an immunologic reaction to MM-121 (i.e. human anti-human antibodies).|Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 88.1 weeks, and a collection was made post-infusion in any case of infusion reaction|||||||Number
2675371|NCT01447225|Secondary|Pharmacokinetics (AUClast)|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the AUClast. Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg) and per study part (Part 1 or Part 2).|Collections taken at Cycle 1, Week 1 for all patients at the start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion||||hr* ug/mL||Geometric Coefficient of Variation|Geometric Mean
2675372|NCT01447225|Secondary|Pharmacokinetics|Pharmacokinetic (PK) evaluation was performed on plasma samples obtained weekly for the first cycle of the study and then on day 1 of each additional cycle to assess pre-treatment trough concentrations of MM-121. Non-compartmental analysis (NCA) was performed to calculate standard PK parameters, including the maximum observed concentration (Cmax). Serum levels of MM-121 were measured at a central lab using an enzyme-linked immunosorbent assay (ELISA). Data is presented per dose level of MM-121 (12 mg/kg, 20 mg/kg, or 40/20 mg/kg).|Collections taken at Cycle 1, Week 1 for all patients at start of the infusion (pretreatment), at the end of the infusion, and at 2, 4, 24 and 48 hours after the start of the MM-121 infusion||||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2675373|NCT01447225|Secondary|Objective Response Rate|To determine the number of patients reporting an objective response using RECIST v 1.1 where a Partial Response (PR) is defined as >20% decrease in tumor burden from baseline and a Complete Response (CR) is defined as complete disappearance from tumor burden from baseline. Objective Response is presented as the total # patients with PR or CR.|patients were assessed for response during their time on study, the longest of which was 88.1 weeks||||participants with objective response|||Number
2675374|NCT01447225|Primary|To Characterize Dose-limiting Toxicities (DLTs) Associated With the Combination of MM-121 With Anticancer Therapies|To establish the safety of escalating doses of MM-121 administered in combination with multiple anti-cancer therapies in order to determine the recommended phase 2 dose. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD to be used for the expansion cohort. DLTs were not measured in the Expansion Cohort.|From date of first dose to 30 days after termination, the longest 88.1 weeks||||participants reporting DLTs|||Number
2675375|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Cabazitaxel|"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Cabazitaxel doses tested: 20 or 25 mg/m2 Day 1 of 3"|From date of first dose to 30 days after termination, the longest 88.1 weeks||||mg/m2|||Number
2675376|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Pemetrexed|"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Pemetrexed doses tested: 500 mg/m2 Day 1"|From date of first dose to 30 days after termination, the longest 88.1 weeks||||mg/m2|||Number
2675400|NCT01446796|Secondary|Functional Capacity and Symptoms|To determine whether continuous RV pacing improves functional capacity and symptoms as measured by six minute walk test and symptoms questionnaires in the early post-LVAD implantation period.|14 days|Study terminated early due to low accrual. No data analysis completed.||||||
2675377|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Carboplatin|"Maximum Tolerated Dose reported in Target AUC, as calculated by the Calvert Formula~Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Carboplatin doses tested: 5 or 6 AUC Day 1"|From date of first dose to 30 days after termination, the longest 88.1 weeks||||target AUC (mg*min/mL)|||Number
2675378|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: Gemcitabine|"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Gemcitabine doses tested: 1000 mg/m2 Day 1 and 8"|From date of first dose to 30 days after termination, the longest 88.1 weeks|NOTE: Maximum tolerated dose is for the combination of gemcitabine and MM-121. MTD of MM-121 is provided in separate endpoint.|||mg/m2|||Number
2675379|NCT01447225|Primary|To Determine the Maximum Tolerated Dose (MTD) of MM-121 in Combination With Anticancer Therapies: MM-121 Doses|"Using a 3+3 dose escalation model, the maximum tolerated dose of each therapy combination was determined by assessing dose-limiting toxicities in each cohort. If 3 patients were treated and passed the observation window, escalation to the next cohort was initiated. If a DLT was reported, 3-4 additional patients were enrolled and observed. If a DLT was observed in expanded cohort, this dose was considered to be the maximum tolerated dose. The maximum tolerated dose was defined at the cohort in which two dose-limiting toxicities were observed, or as the highest target dose tested in the absence of DLTs. The determined MTD was considered the Recommended Phase 2 Dose.~Dose Levels (3 week cycles) MM-121 doses tested: 20 mg/kg IV one-time loading dose then 12 mg/kg IV QW (20/12 mg/kg); 40/20 mg/kg Gemcitabine doses tested: 1000 mg/m2 Day 1 and 8 Pemetrexed doses tested: 500 mg/m2 Day 1 Carboplatin doses tested: 5 or 6 AUC Day 1 Cabazitaxel doses tested: 20 or 25 mg/m2 Day 1 of 3"|From date of first dose to 30 days after termination, the longest 88.1 weeks|Note: data provided below is for MM-121 doses only for the combination. Combination therapy MTDs are provided in separate endpoint measures.|||mg/kg|||Number
2675380|NCT01447225|Primary|To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Anticancer Therapies|Safety and tolerability data presented in detail in the adverse events and serious adverse events section of the results posting|From date of first dose to 30 days after termination, the longest 88.1 weeks||||participants reporting adverse events|||Number
2675381|NCT01447121|Secondary|Number of Study Staff Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method When Testing Subject Blood Glucose (BG)|Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS), which included an investigational meter and sensor. BGM results were compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results were used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG results >=75mg/dL) of the reference method results.|1 hour|115 (115x1) test results are possible. Staff tested blood from 118 subjects (one of 3 test strip lots). All study results from 2 subjects were excluded from data analyses as already described. Also, one test exceeded time interval (defined in protocol) between meter test and reference method.|||BG test results|||Number
2675382|NCT01447121|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes tested self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS), which included an investigational meter and sensor. BGM results were compared with capillary plasm BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results were used to calculate the number of BG results within +/- 15 mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG results >=75mg/dL) of the reference method results (YSI capillary plasma).|1 hour|115(115x1)test results are possible. 118 subjects tested one of 3 test strip lots on the BGM system. Study results from 2 subjects were excluded from all data analyses as already described. One subject test exceeded time interval (defined in protocol) between meter test and reference method.|||BG test results|Participants||Number
2675383|NCT01447017|Primary|Adverse Events (AEs)|"AEs were collected by a non-leading question such as have you experienced any new health problems or worsening of existing conditions as well as reporting events directly observed or spontaneously volunteered by patients. All AEs including but not limited to events reported by the patient, or reported in answer to an open question by the Investigator or member of the study team were recorded as an AE including the following information: Diagnosis; Start date (and time, if relevant), Stop date (and time, if relevant) or resolution; Severity; Action taken; Causality; Seriousness; Outcome."|"AEs occurring during the treatment period were collected on day 8 or 11, as applicable. Four weeks after the last dose of investigational medicinal product (IMP), previously reported AEs were followed up and assessed as recovered or not recovered."|All safety analyses were performed on safety analysis set. All randomised patients who received at least 1 dose of the IMP and had at least 1 safety follow-up performed were included in the safety analysis set.|||participants|||Number
2675384|NCT01446874|Secondary|Incidence of Fever||Within 24 hours of surgery|None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing.|||Participants|||Count of Participants
2675385|NCT01446874|Secondary|Postoperative Respiratory Failure|Postoperative respiratory failure = need for postoperative mechanical ventilation, need for bronchoscopy for atelectasis, need for tracheostomy|Within 30 days of surgery|None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing.|||Participants|||Count of Participants
2675386|NCT01446874|Secondary|Perioperative Mortality||Within 30 days of surgery|None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing.|||Participants|||Count of Participants
2675387|NCT01446874|Secondary|Compliance With Oral Hygiene Regimen as Measured by the Number of Participants Who Completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire|Compliance is measured by the number of participants who completed the Modified Morisky Medication/Intervention Adherence Scale and Knowledge Questionnaire|Within 30 days of surgery|None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing and the participants did not complete the questionnaire.|||Participants|||Count of Participants
2675388|NCT01446874|Secondary|Compliance With Oral Hygiene Regimen as Measured by a Daily Brushing Diary||Within 30 days of surgery (comparing pre-op and post-op)|The Pilot Portion is not included in this outcome measure. 3 participants in the esophageal resection group was not evaluable for this outcome measure.|||Participants|||Count of Participants
2675389|NCT01446874|Primary|Adherence to the Pre-operative Toothbrushing Regimen||Completion of pre-operative toothbrushing (three times a day for 5 days prior to surgery)|This outcome measure was for only the pilot portion of the study.|||Participants|||Count of Participants
2675390|NCT01446874|Primary|Number of Participants Who Develop Postoperative Pneumonia in the Two Groups: Lung Cancer Resection Patients and Esophageal Resection Patients|"Patients will be considered to have postoperative pneumonia if they meet three of the following criteria within 30 days after surgery;~Fever (Temperature >38.2 C)~Leucocytosis (WBC>12,000/cu mm)~New infiltrate on chest X-ray~Positive sputum or bronchial culture~Treatment with antibiotics These criteria are utilized by the national Society of Thoracic Surgeons' database."|Within 30 days of surgery|-None of the participants from the pilot portion are included in this outcome measure as the pilot portion only measured compliance of pre-operative toothbrushing.|||Participants|||Count of Participants
2675391|NCT01446809|Secondary|Progression Free Survival|Defined as the duration of time from randomization to progressive disease (per RECIST), local recurrence, distant metastatic disease (exclusive of stage IV subjects), or death, whichever occurs first.|Up to 3 years||||Participants|||Count of Participants
2675392|NCT01446809|Secondary|Number of Participants With Pathologic Response at the Time of Surgery as Measured by % Tumor Viability ( >= 95% Necrosis)|Estimate the amount of viable tumor, and report the percentage of necrosis. Analysis was only completed on a subset of participants.|An expected average of 12 weeks||||Participants|||Count of Participants
2675393|NCT01446809|Secondary|Overall Survival|Defined as the interval of time from randomization until death from any cause.|Up to 3 years||||Participants|||Count of Participants
2675394|NCT01446809|Secondary|Change in Levels of VEGF and Soluble VEGFR2 Assessed by ELISA on Plasma and Tumor Extracts|Plasma will be collected for measurement of VEGF and soluble VEGFR2 (sVEGFR2) at baseline, after the 14 day Run-in period of pazopanib, after completion of neoadjuvant chemotherapy and approximately every 3 months thereafter until completion of pazopanib maintenance therapy, when indicated. Quantitative enzyme-linked immunosorbent assays (ELISA) for VEGF and sVEGFR2 will be performed on plasma and tumor extracts. Plasma will also be collected for micro RNA at baseline, after the 14 day Run-in period of pazopanib, following neoadjuvant chemotherapy and every 3 months thereafter until completion of pazopanib maintenance therapy, when indicated.|At baseline and after 14 days||||percentage of concentration|||Number
2675395|NCT01446809|Primary|Pharmacokinetic Profile of Pazopanib|Trough plasma pazopanib concentration measured during the 14 day run-in period on days 10 through 14.|Up to 14 days||||ng/mL||Standard Deviation|Mean
2675396|NCT01446809|Primary|Tumor Response by RECIST Criteria|RECIST measurements will be performed on serial MRIs to evaluate the correlation with FDG-PET. The longest diameter (LD) of the target lesions will be measured and reported as the baseline LD. The baseline LD will be used as reference to further characterize the objective tumor response of the measurable dimension of the disease.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression (PD), a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|At 8 weeks|8 week MRI not done on one Placebo patient.|||Participants|||Count of Participants
2675397|NCT01446809|Primary|Tumor Response by RECIST Criteria|RECIST measurements will be performed on serial MRIs to evaluate the correlation with FDG-PET. The longest diameter (LD) of the target lesions will be measured and reported as the baseline LD. The baseline LD will be used as reference to further characterize the objective tumor response of the measurable dimension of the disease.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression (PD), a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|At 15 days|"Per RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the LD of target lesions; Progression (PD),20% increase in the sum of the LD of target lesions,or measurable increase in a non-target lesion,or appearance of new lesions.,"|||Participants|||Count of Participants
2675398|NCT01446809|Primary|Change in Maximum SUV of Tumors Measured by FDG-PET Post Receipt of 2 Courses of Preoperative Chemotherapy|Change in maximum SUV of tumors measured by FDG-PET. Comparison conducted using a two-sided Wilcoxon rank sum test.|From baseline to 8 weeks|8 week PET not done on one Pazopanib participant.|||SUV||Full Range|Median
2675399|NCT01446809|Primary|Change in Maximum SUV of Tumors Measured by FDG-PET Pre- and Post Receipt of Pazopanib Versus Placebo|Change in maximum SUV (standardized uptake value) of tumors measured by FDG-PET. Comparison conducted using a two-sided Wilcoxon rank sum test.|From baseline to 15 days||||Standardized uptake value-SUV||Full Range|Median
2675401|NCT01446796|Secondary|Right Ventricular Function|To determine whether continuous RV pacing improves invasive and non-invasive measures of RV function in the early period post-LVAD implantation. Measured by Pulmonary Artery catheter measures of intra-cardiac pressures and cardiac output in the ICU setting and by qualitative and quantitative Echocardiographic measures of RV function during the hospital course.|14 days|Study terminated early due to low accrual. No data analysis completed.||||||
2675402|NCT01446796|Secondary|Post-operative Need for Hemodynamic / Respiratory Support|To determine whether continuous RV pacing reduces the need for inotropic / vasoactive agents, mechanical ventilation, or other circulatory support in the early post-operative period. Measured by the number of hemodynamic and respiratory support interventions and duration of those interventions.|14 days|Study terminated early due to low accrual. No data analysis completed.||||||
2675403|NCT01446796|Primary|Length of Hospitalization|To determine whether continuous RV pacing reduces ICU length of stay (number of days) and overall hospital length of stay (number of days) post-LVAD implantation.|14 days|Study terminated early||||||
2675404|NCT01446705|Secondary|Health Care Quality: Care Sensitive Admissions|This study will use the Agency for Healthcare Research and Quality's (AHRQ) Prevention Quality Indicators (PQI) to calculate the outcome measure. The PQIs are a set of measures used with hospital inpatient data to identify ambulatory care sensitive conditions. The PQIs consist of 14 conditions. The study will adopt 12 that are commonly used for adult patients: angina, asthma, bacterial pneumonia, chronic obstructive pulmonary disease, congestive heart failure, dehydration, diabetes long-term complications, diabetes short-term complications, diabetes uncontrolled, hypertension, lower-limb amputation among diabetes patients, and urinary infection.|3 years|This analysis looked specifically at hospitalizations within a cohort of diabetes patients (a subset of the whole).|||ACS Hospitalizations per 100k patients|||Number
2675405|NCT01446705|Primary|Health Care Quality: Affect of HIE on LDL Levels of Participants.|This study will measure the impact of HIE upon health care quality the underuse of ambulatory care services for diabetics. Measurements of underuse before and after implementation will detect improvements in the quality of care. To measure underuse, the study employs a measurement set that is sensitive to the potential effects and feasible for electronic data capture. In this specific instance, we expect the LDL levels to reflect lower numbers among diabetics due to greater health management via information sharing.|3 years|These are diabetics within the cohort defined as being diagnosed, alive, and being aged 18-75. Specifically looking at LDL|||mg/dL of LDL||95% Confidence Interval|Least Squares Mean
2675406|NCT01446705|Primary|Effect of Health Information Exchange on Cost|Before after analysis of the presence of health information exchange on costs within the VA healthcare system; Measure is cost, unadjusted, in dollars for the year post enrollment in the health information exchange|2 Years|5269 individuals were excluded due to lacking cost information.|||$ per year unadjusted total VA cost||Standard Deviation|Median
2675407|NCT01446705|Primary|Understanding Utilization of Healthcare Procedures by Veterans According to Source of Data|Determining rates of usage of healthcare by veterans by source of data. This will clue us into any differences in utilization patterns between groups.|2 years|Veterans divided into enrolled and non-enrolled in HIE groups|||participants|||Number
2675408|NCT01446666|Secondary|Positive Predictive Value for HCC|The positive predictive value was the number of true positive test results in patients with the positive tests in a specific modality.|during the 1.5-year study period (from the date of first screening to 6 months following the last screening)||||percentage of true positive calls|||Number
2675409|NCT01446666|Secondary|False Positive Rate|The false-positive rate was defined as the number of tests with positive findings by a specific imaging modality in patients without a HCC.|during the 1.5-year study period (from the date of first screening to 6 months following the last screening)||||percentage of false positive test|the number of exams||Number
2675410|NCT01446666|Secondary|Detection Rate of Patients With Very Early Stage HCC|"The number of patients with HCC nodules of very early stage detected by a given modality divided by the total number of definite HCC nodules of very early stage detected by any of 2 modalities plus interval cancers.~Very early stage (stage 0) HCC is defined by the Barcelona Clinic Liver Cancer staging system (BCLC): A single HCC <2 cm without gross vascular invasion or extrahepatic metastasis."|during the 1.5-year study period (from the date of first screening to 6 months following the last screening)|Of the 43 patients, 32 (74.4%) had very early-stage.|||percentage of detected very early HCC|||Number
2675411|NCT01446666|Secondary|Detection Rate of Patients With Early Stage HCC|"The number of patients with early stage HCC detected by a given modality divided by the total number of patients with early stage HCC detected by any of 2 modalities plus interval cancers.~Early stage (stage A or 0) HCC is defined by the Barcelona Clinic Liver Cancer staging system (BCLC): A single HCC <5 cm or <=3 lesions each <3 cm in diameter, without gross vascular invasion or extrahepatic metastasis."|during the 1.5-year study period (from the date of first screening to 6 months following the last screening)||||percentage of early HCC detected|||Number
2675412|NCT01446666|Primary|Detection Rate of Patients With HCC|- The number of patients with definite HCC detected by a given modality divided by the total number of patients with definite HCC detected by any of 2 modalities plus interval cancers|during the 1.5-year study period (from the date of first screening to 6 months following the last screening)||||percentage of HCC detected on each exam|||Number
2675413|NCT01446419|Secondary|Change in ODI From Baseline to 6 Months Post-treatment|"The improvement in ODI at 6 months compared to baseline.~ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms."|6 months|Per Protocol Population: subjects that received the intended therapy per randomization assignment (appropriate ablation of the basivertebral nerve in the Intracept System arm) and completed follow-up per the study protocol.|||units on a scale||95% Confidence Interval|Least Squares Mean
2675427|NCT01446250|Secondary|Percentage of Participants With Emergence of Resistant Mutations||within 48 weeks|No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.||||||
2675477|NCT01445951|Secondary|FEV1 Change From Baseline to Week 24|Forced Expiratory Volume in 1 second - change from baseline to week 24|Baseline to Week 24|Safety population|||Liters||Standard Error|Least Squares Mean
2675414|NCT01446419|Secondary|Patient Success at 3 Months|"Proportion of subjects with clinical success at 3 months, where clinical success was defined as:~3 month ODI score represented at least a 15-point reduction from baseline~no device or procedure related SAE between baseline and 3 mos.~no increase in opioid use between procedure and 3 mos.~no deficit in a motor or dermatomal sensory group at the treated level at 3 mos.~no operative interventions or invasive procedures for lumbar back pain by a pain management or spinal specialist between procedure and 3 mos."|3 months|Per Protocol Population: subjects that received the intended therapy per randomization assignment (appropriate ablation of the basivertebral nerve in the Intracept System arm) and completed follow-up per the study protocol.|||percentage of patients|||Number
2675415|NCT01446419|Primary|Change in ODI From Baseline to 3 Months Post-treatment|"The primary variable is the Oswestry Disability Index (ODI) and the primary efficacy endpoint is the mean improvement from baseline to 3 months in the ODI. The primary endpoint will be evaluated in both the treatment and sham groups with between-group comparisons used to assess the success of the Intracept System in reducing chronic axial low back pain.~ODI is a patient questionnaire that assesses back dysfunction due to back pain. There are 10 questions that are scored from 0-5. The obtained score is multiplied by 2 to produce a percentage score that is reported on a scale of 0-100. Scores are interpreted as follows: 0-20% minimum disability; 21-40% moderate disability; 41-60% severe disability; 61-80% crippled; 81-100% bed bound or exaggerating their symptoms."|3 months|Per Protocol Population: subjects that received the intended therapy per randomization assignment (appropriate ablation of the basivertebral nerve in the Intracept System arm) and completed follow-up per the study protocol.|||units on a scale||95% Confidence Interval|Least Squares Mean
2675416|NCT01446289|Secondary|Percentages of Infants Reporting SAEs|Percentages of infants born from women who received either one injection of the study vaccine or placebo, reporting SAEs from birth until study termination are reported.|From birth until study termination|The analysis was done on the Safety Set.|||Percentages of subjects|||Number
2675417|NCT01446289|Secondary|Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs)|Percentage of maternal subjects reporting unsolicited AEs, SAEs, AEs requiring a non-routine physician's visit, AEs leading to withdrawal are reported.|All AEs were recorded until delivery, after delivery all AEs requiring a non-routine physician's visit and AEs leading to withdrawal from the study. SAEs were collected for the duration of the trial.|The analysis was done on the Safety Set.|||Percentages of subjects|||Number
2675418|NCT01446289|Secondary|Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)|Percentage of maternal subjects reporting solicited local and systemic AEs and other indicators of reactogenicity from day 1 to 7 after vaccination are reported.|From day 1 to 7 after vaccination|The analysis was done on the Safety Set, ie, all subjects in the enrolled population who received a study vaccination, provided post vaccination safety data, provided post-baseline safety data.|||Percentages of subjects|||Number
2675419|NCT01446289|Secondary|Percentages of Infant Subjects Showing Anti-diphtheria Antibodies GMCs (ELISA) Over 0.1 IU/mL at 1 Month After the Last Routine Infant Immunization|Percentages of infant subjects showing anti-diphtheria antibodies GMCs (ELISA) over 0.1 IU/mL in sera collected at 1 month after the last routine infant immunization (ie, either 5 months or 7 months after birth, depending on the vaccination schedule) are reported.|1 month after the last routine infant immunization|The analysis was done on the Immunogenicity PPS.|||Percentages of subjects||95% Confidence Interval|Number
2675420|NCT01446289|Secondary|GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth|GMRs of anti-GBS CPS antibody GMCs (ELISA) against serotypes Ia, Ib and III in infants at 3 months of age (day 91 after birth) versus GMCs at birth are reported.|Day 91 after birth|The analysis was done on the Immunogenicity PPS.|||Ratio||95% Confidence Interval|Geometric Mean
2675421|NCT01446289|Secondary|GMC (ELISA) of Anti-GBS CPS Antibodies in Infants|GMC (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III in infants at birth and at 3 months of age are reported.|Day of birth and day 91 after birth|The analysis was done on the Immunogenicity PPS.|||μg/mL||95% Confidence Interval|Geometric Mean
2675422|NCT01446289|Secondary|Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects|GMRs of GMCs (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III, in maternal subjects at study day 31, at delivery and at day 91 post-partum versus day 1 (baseline) after one administration of GBS vaccine or placebo are reported.|Day 31, day of delivery, day 91 post-delivery|The analysis was done on the Immunogenicity PPS.|||Ratio|Participants|95% Confidence Interval|Geometric Mean
2675423|NCT01446289|Secondary|GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects|GMCs (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III in maternal subjects at study day 1, study day 31 and at day 91 post-partum after one administration of GBS vaccine or placebo are reported.|Day 1, day 31 and day 91 post-delivery|The analysis was done on the Immunogenicity PPS.|||µg/mL||95% Confidence Interval|Geometric Mean
2675424|NCT01446289|Primary|Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery|The Geometric mean transfer ratio of anti-GBS CPS antibodies against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.|Day of delivery/birth|The analysis was done on the Immunogenicity PPS.|||Ratio||95% Confidence Interval|Geometric Mean
2675425|NCT01446289|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth|GMCs of anti-Group B Streptococcus (GBS) capsular polysaccharide (CPS) antibodies against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.|Day of delivery/birth|The analysis was done on the Immunogenicity Per Protocol Set (PPS), ie: all subjects in the enrolled population who correctly received the vaccine, provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to un-blinding.|||µg/mL||95% Confidence Interval|Geometric Mean
2675426|NCT01446250|Secondary|Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 24 Weeks After the End of Treatment (SVR24)|SVR24 was defined as hepatitis C virus (HCV) RNA undetectable (by limit of detection) 24 weeks after end of treatment.|24 weeks post-treatment|No data has been reported because planned data analyses were not performed as the study was terminated before the outcome measure time point.||||||
2675429|NCT01446237|Secondary|Mean Change in ISGA From Baseline to Each Study Visit|The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value.|Baseline (Day 1) and Week 1, 2, 4, 8, 12|ITT population. Only those participants with data available at the indicated time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2675430|NCT01446237|Secondary|Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit|The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extends from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value.|Baseline (Day 1) and Week 1, 2, 4, 8, 12|ITT population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in category titles).|||Lesions||Standard Deviation|Mean
2675431|NCT01446237|Primary|Number of Participants With ISGA Score of 0 (Clear) or 1 (Almost Clear) at Each Study Visit|The investigator assessed efficacy at baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions).|Week 1, 2, 4, 8 and 12|ITT population.|||Participants|||Number
2675432|NCT01446237|Primary|Number of Participants With a Minimum 2-grade Improvement of Investigator's Static Global Assessment (ISGA) From Baseline to Each Study Visit|The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value.|Baseline (Day 1) and Week 1, 2, 4, 8, 12|ITT population. Only those participants with data available at that particular time points were analyzed.|||Participants|||Number
2675433|NCT01446237|Primary|Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit|The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extended from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. Mean percent change from baseline at each study visit was presented.|Baseline (Day 1) and Week 1, 2, 4, 8, 12|Intent-to-treat (ITT) population consisted of all participants that were enrolled in the study. Only those participants with data available at the indicated time points were analyzed.|||Percent change in lesions||Standard Deviation|Mean
2675434|NCT01446159|Secondary|Phase 1b and Phase 2: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI-573|Participants With Positive ADA to MEDI-573 are reported.|Pre-infusion on Day 1 of each cycle, End of Treatment, Day 30, 60 and 90 post treatment (approximately 6 years)|Participants who received MEDI-573 and were analysed per the treatment they actually received were analysed for this outcome measure.|||Participants|||Count of Participants
2675435|NCT01446159|Secondary|Phase 1b and Phase 2: Concentration of Insulin-like Growth Factor (IGF) I and IGF-II|The mean concentration profiles of both IGF-I and IGF-II post administration of MEDI-573 in plasma were evaluated during treatment.|Baseline (Cycle1 Day1 pre-dose), end of treatment (EOT), and 60 days post last dose (Approximately 6 years)|Safety population included all participants who received any study therapy and were analysed per the treatment they actually received. Participants with free IGF concentration were analysed.|||ng/mL||Standard Deviation|Mean
2675436|NCT01446159|Secondary|Phase 1b and Phase 2: Terminal Half Life (t1/2) of MEDI-573 for Cycle 1|The elimination half-life (t1/2) is the time measured for the serum concentration of MEDI-573 to decrease by 1 half to its original concentration.|Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)|The ITT population was considered for this analysis. Participants who received MEDI-573 were analysed.|||Day||Standard Deviation|Mean
2675437|NCT01446159|Secondary|Phase 1b and Phase 2: Systemic Clearance (CL) of MEDI-573 for Cycle 1|The CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose was estimated by dividing the total administered dose by AUC(0-infinity).|Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)|The ITT population was considered for this analysis. Participants who received MEDI-573 were analysed.|||mL/day/kg||Standard Deviation|Mean
2675438|NCT01446159|Secondary|Phase 1b and Phase 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of MEDI-573 for Cycle 1||Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)|The ITT population was considered for this analysis. Participants who received MEDI-573 were analysed.|||Day||Full Range|Median
2675439|NCT01446159|Secondary|Phase 1b and Phase 2: Maximum Observed Serum Concentration (Cmax) of MEDI-573 for Cycle 1||Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)|The ITT population was considered for this analysis. Participants who received MEDI-573 were analysed.|||μg/mL||Standard Deviation|Mean
2675440|NCT01446159|Secondary|Phase 1b and Phase 2: Dose-Normalised Area Under the Serum Concentration-time Curve From Time Zero to Infinity (DN AUC0-inf) of MEDI-573 for Cycle 1||Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)|The ITT population was considered for this analysis. Participants who received MEDI-573 were analysed.|||day·kg·μg/mL/mg||Standard Deviation|Mean
2675441|NCT01446159|Secondary|Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI-573 for Cycle 1||Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)|The ITT population was considered for this analysis. Participants who received MEDI-573 were analysed.|||μg·day/mL||Standard Deviation|Mean
2675442|NCT01446159|Secondary|Phase 1b and Phase 2: Area Under the Serum Concentration-time Curve From Time Zero to Day 21 (AUC0-day21) of MEDI-573 for Cycle 1||Cycle 1 Days 1, 2, 8, 15, and 21 (Cycle 2 Day 1, pre-dose)|The ITT population was considered for this analysis. Participants who received MEDI-573 were analysed.|||μg·day/mL||Standard Deviation|Mean
2675443|NCT01446159|Secondary|Phase 2: Change in Tumor Size||From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 6 years)|The ITT population included all participants who received any study therapy and were analysed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analysed.|||Centimeters||Standard Deviation|Mean
2675444|NCT01446159|Secondary|Phase 2: Overall Survival (OS)|Overall survival (OS) was measured from treatment start until death.|From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 6 years)|The ITT population included all participants who received any study therapy and were analysed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analysed.|||Months||Full Range|Median
2675445|NCT01446159|Secondary|Phase 2: Time to Progression (TTP)|Time to progression was measured from treatment start until the first documentation of disease progression. The PD was defined as >= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion.|From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 6 years)|The ITT population included all participants who received any study therapy and were analysed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analysed.|||Months||Full Range|Median
2675446|NCT01446159|Secondary|Phase 2: Duration of Response (DR)|Duration of response (DR) is measured from the first documentation of disease response to the first documented progressive disease and was evaluated only in participants who achieved objective response (confirmed CR or confirmed PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was defined as >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions.|From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 6 years)|The ITT population included all participants who received any study therapy and were analysed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analysed.|||Months||Full Range|Median
2675447|NCT01446159|Secondary|Phase 2: Time to Response|Time to response was measured from treatment start to the first documentation of disease response and was evaluated only in participants who achieved objective response (confirmed CR or confirmed PR. The CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was defined as >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions.|From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 6 years)|The ITT population included all participants who received any study therapy and were analysed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analysed.|||Months||Full Range|Median
2675448|NCT01446159|Secondary|Phase 2: Objective Response Rate (ORR)|The ORR was defined as percentage of participants with confirmed complete response or confirmed partial response, where CR was defined as disappearance of all target and non-target lesions and no new lesions and PR was definded as >= 30% decrease in the sum of diameters of Target Lesions (compared to baseline) and no new lesions.|From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 6 years)|The ITT population included all participants who received any study therapy and were analysed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analysed.|||Percentage of participants||95% Confidence Interval|Number
2675449|NCT01446159|Secondary|Phase 2: Number of Participants With Best Overall Tumor Response|Tumor evaluation was based on RECIST v1.1 by CT or MRI scan as: Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions; Partial Response (PR): >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new lesions; Stable disease (SD): Neither sufficient shrinkage to qualify as a response nor sufficient growth to qualify as progression; Progressive Disease (PD): >= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion; not evaluable (NE): either no or only a subset of lesion measurements are made at an assessment.|From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 6 years)|The ITT population included all participants who received any study therapy and were analysed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analysed.|||Participants|||Count of Participants
2675450|NCT01446159|Secondary|Phase 1b and Phase 2: Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs|An abnormal ECG findings that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 6 years).|From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 6 years)|Safety population included all participants who received any study therapy and were analysed per the treatment they actually received.|||Participants|||Count of Participants
2675478|NCT01445951|Primary|Change From Baseline to Week 24 in HbA1c|Effect of treatment as measured by change from baseline in glycated hemoglobin (HbA1c). Primary treatment difference is TI-Gen2 vs. Insulin Aspart at Week 24|Baseline to Week 24|Full analysis set|||Percent of hemoglobin||Standard Error|Least Squares Mean
2675451|NCT01446159|Secondary|Phase 1b and Phase 2: Number of Participants With Abnormal Vital Signs Reported as TEAEs|An abnormal vital signs that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 6 years).|From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 6 years)|Safety population included all participants who received any study therapy and were analysed per the treatment they actually received.|||Participants|||Count of Participants
2675452|NCT01446159|Secondary|Phase 1b and Phase 2: Number of Participants With Abnormal Clinical Laboratory Results Reported as TEAEs|An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 6 years).|From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 6 years)|Safety population included all participants who received any study therapy and were analysed per the treatment they actually received.|||Participants|||Count of Participants
2675453|NCT01446159|Primary|Phase 2: Progression-free Survival (PFS)|"Progression-free survival (PFS) was defined as the time from the randomization until the first documentation of disease progression or death due to any cause, whichever occurred first.~The PFS was censored on the date of the last tumor assessment documenting absence of tumor progression for participants who had no documented progression and were still alive prior to data cut-off, dropout, or the initiation of alternate anticancer treatment. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as >= 20% increase in the sum of diameters of target lesions and an absolute increase in sum of diameters of >=5mm (compared to the previous minimum sum) or progression of non-target lesions or a new lesion."|From Day 1 until disease progression or death due to any cause, whichever occurred first (Approximately 6 years)|The ITT population included all participants who received any study therapy and were analysed per their randomized treatment group. Participants enrolled in Phase 2 of the study were analysed.|||Months||95% Confidence Interval|Median
2675454|NCT01446159|Primary|Phase 1b: Number of DLTs|The AEs that occurred during Cycle 1 (Days 1 to 21) and were suspected of having a causal relationship to MEDI-573 and were >= Grade 3 in severity were considered as DLTs.|Up to Day 21 of Cycle 1|Evaluable population included all participants in Phase 1b of the study, who received at least 1 full cycle of MEDI-573 and completed the safety follow-up through the DLT evaluation period (Days 1 to 21 of Cycle 1).|||DLT events|||Number
2675455|NCT01446159|Primary|Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs)|The AEs that occurred during Cycle 1 (Days 1 to 21) and were suspected of having a causal relationship to MEDI-573 and were >= Grade 3 in severity were considered as DLTs.|Up to Day 21 of Cycle 1|Evaluable population included all participants in Phase 1b of the study, who received at least 1 full cycle of MEDI-573 and completed the safety follow-up through the DLT evaluation period (Days 1 to 21 of Cycle 1).|||Participants|||Count of Participants
2675456|NCT01446159|Primary|Phase 1b and Phase 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An Adverse Event (AE) is any unfavourable and unintended sign, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. A serious adverse event (SAE) is an AE that results in death, initial or prolonged inpatient hospitalization, life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or an important medical event. TEAEs and TESAEs are defined as AEs and SAEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 60 days after the last study drug or until the participants started another anticancer therapy, whichever occurs first (approximately 6 years).|From the start of study treatment (Day 1) through 60 days after the last dose of treatment or until the participants started another anticancer therapy, whichever occurs first (approximately 6 years)|Safety population included all participants who received any study therapy and were analysed per the treatment they actually received.|||Participants|||Count of Participants
2675457|NCT01446042|Secondary|Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90|"To determine the efficacy of 4.5% TBS-1 gel, administered 2 or 3 times daily at a dose of 5.5 mg per nostril, in achieving the following serum total testosterone maximum concentration (Cmax) on Day 90:~A Cmax (maximum testosterone concentration) value of 1500 ng/dL or more in at least 85% of the participants analyzed~A Cmax (maximum testosterone concentration) value of 1800 to 2500 ng/dL in fewer than 5% of participants analyzed~No analyzed participants with a Cmax (maximum testosterone concentration) >2500 ng/dL"|90 days|ITT subjects who have a Cmax value at the specified visit.|||Participants|||Count of Participants
2675458|NCT01446042|Primary|Serum Testosterone Cavg|The percentage of patients with an average serum total testosterone concentration (Cavg) within the normal range (300 to 1050 ng/dL)|90 days|Per-Protocol Population|||Participants|||Count of Participants
2675459|NCT01446003|Primary|Number of Participants Who Discontinued the Study Medication Due to an AE|An AE is defined as any unfavorable and unintended medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 70 days|The safety population consisted of all participants who received at least one dose of the investigational drug.|||Participant|||Number
2675460|NCT01446003|Primary|Number of Participants Who Experienced at Least One Adverse Event (AE)|An AE is defined as any unfavorable and unintended medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Up to 70 days|The safety population consisted of all participants who received at least one dose of the investigational drug.|||Participant|||Number
2675461|NCT01446003|Secondary|Trough Plasma Concentration (Ctrough) of MK-8457|The lowest plasma concentration reached by the drug prior to the next administration was determined for Day 1 (after initial dosing) and Day 10 (after multiple dosing). The placebo group was not included; this endpoint evaluated only the MK-8457 group.|pre-AM dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post AM dose on Days 1 and 10; pre-AM dose on Day 5 or 6|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (Ctrough).|||nM||Geometric Coefficient of Variation|Geometric Mean
2675462|NCT01446003|Secondary|Time to Maximum Concentration (Tmax) of MK-8457|Tmax was determined for the AM dose on Day 1 and Day 10. The placebo group was not included; this endpoint evaluated only the MK-8457 group.|pre-AM dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post AM dose on Days 1 and 10; 24 hrs post-AM dose on Day 10|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (Tmax).|||hr||Full Range|Median
2675463|NCT01446003|Secondary|Maximum Concentration (Cmax) of MK-8457|Maximum plasma concentrations of MK-8521 were determined for the AM dose on Day 1 and Day 10. The placebo group was not included; this endpoint evaluated only the MK-8457 group.|pre-AM dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post AM dose on Days 1 and 10; 24 hrs post-AM dose on Day 10|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (Cmax).|||nM||Geometric Coefficient of Variation|Geometric Mean
2675464|NCT01446003|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours (AUC0-12hr) of MK-8457|AUC0-12hr is an estimate of total plasma exposure to study drug over the dosing interval (12hr). Plasma concentrations of MK-8457 were determined on Day 1 (after initial dosing) and Day 10 (after multiple dosing). The placebo group is not included; this endpoint evaluated only the MK-8457 group.|pre-AM dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hrs post AM dose on Days 1 and 10|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (AUC0-12hr).|||nM*hr||Geometric Coefficient of Variation|Geometric Mean
2675465|NCT01446003|Secondary|Change From Baseline to Day 10 in Maximum Moving Average (maxMAΔ) Blood Pressure Measured Over 4 Hours|The effect of drug on resting blood pressure was estimated using maxMAΔ. The maxMAΔ in blood pressure was calculated as the maximum moving average change from baseline to Day 10 of 3 consecutive 15-minute blood pressure measurements across the first 4 hours after the morning (AM) and evening (PM) doses. In this method, the LS means of three consecutive time points over the 4 hour period were determined and the maximum LS mean was used for the endpoint. Blood pressure was determined using continuous monitoring at rest. Increased values represent an increase in hypertensive severity.|Up to 4 hours postdose on Days 1 and 10|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (maxMAΔ in blood pressure).|||mmHg||95% Confidence Interval|Least Squares Mean
2675466|NCT01446003|Secondary|Change From Baseline to Day 10 in 24-hour Mean Ambulatory Diastolic Blood Pressure (DBP)|DBP was measured using ambulatory blood pressure monitoring (ABPM) on Day -1 and Day 10 of each treatment period. The 24-hour LS mean ambulatory DBP change from baseline was then determined for Day 10, the last day of multiple dose treatment. Baseline is defined as the average 24-hour DBP for each participant on Day -1. Increased values represent an increase in hypertensive severity.|Baseline and Day 10|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (change in 24-hour mean ambulatory DBP).|||mmHg||95% Confidence Interval|Least Squares Mean
2675467|NCT01446003|Primary|Change From Baseline to Day 10 in 24-hour Mean Ambulatory Systolic Blood Pressure (SBP)|SBP was measured using ambulatory blood pressure monitoring (ABPM) on Day -1 and Day 10 of each treatment period. The 24-hour least squares (LS) mean ambulatory SBP change from baseline was then determined for Day 10, the last day of multiple dose treatment. Baseline is defined as the average 24-hour SBP for each participant on Day -1. Increased values represent an increase in hypertensive severity.|Baseline and Day 10|The per-protocol population consisting of participants who comply with the protocol sufficiently to ensure that data were likely to exhibit the effects of treatment according to the underlying scientific model used for analysis (change in 24-hour mean ambulatory SBP).|||mmHg||95% Confidence Interval|Least Squares Mean
2675468|NCT01445951|Secondary|Proportion of Responders Achieving HbA1c <= 7.0%|Efficacy as measured in proportion of subjects achieving HbA1c < or = to 7.0%|Week 24|Full analysis set|||percentage of participants|||Number
2675469|NCT01445951|Other Pre-specified|Severe Hypoglycemia Event Rate|Number of Severe Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 24|Safety population|||Events/Subject-Month|||Number
2675470|NCT01445951|Other Pre-specified|Total Hypoglycemia Event Rate|Number of Hypoglycemic Events/Total Subject Exposure Time (in months)|Baseline to Week 24|Safety population|||Events/Subject-Month|||Number
2675471|NCT01445951|Other Pre-specified|Incidence of Severe Hypoglycemia|Severe Hypoglycemia defined as: Requiring 3rd party assistance.|Baseline to Week 24|Safety population|||percentage of participants|||Number
2675472|NCT01445951|Other Pre-specified|Incidence of Total Hypoglycemia|Hypoglycemia, defined as blood glucose <= 70 mg/dL or in absence of blood glucose, symptoms that are resolved by the administration of carbohydrates.|Baseline to Week 24|Safety population|||percentage of participants|||Number
2675473|NCT01445951|Secondary|Change in Body Weight From Baseline to Week 24|Change in body weight from Baseline to Week 24|Baseline to Week 24|Full analysis set (subjects with data available at Baseline and at Week 24)|||kg||Standard Error|Least Squares Mean
2675474|NCT01445951|Secondary|Mean 7-point Glucose Week 24 Values||Week 24|Full analysis set|||mg/dL||Standard Deviation|Mean
2675475|NCT01445951|Secondary|Mean 7-point Glucose Baseline Values|Mean 7-point glucose at baseline|Baseline|Full analysis set|||mg/dL||Standard Deviation|Mean
2675479|NCT01445886|Secondary|Physician's and Subject's Global Assessment|"The Physician's and Subject's Global Assessment (PGA and SGA) will be assessed by two dermatologists and participant himself/herself respectively after treatment 24 weeks.~A 6-point scale was used for both SGA and PGA: 0 = worse, 1 = 0-24% clearing with little or no change, 2 = 25-49% clearing with slight improvement, 3 = 50-74% clearing with moderate improvement, 4 = 75-99% clearing with striking improvement, 5 = cleared. A score between 3 and 5 was considered to be a positive response and a score between 0 and 2 a poor response."|Week 24||||units on a scale||Standard Deviation|Mean
2675480|NCT01445886|Secondary|Change From Baseline in Modified Target NAPSI for the Single Most Severely Affected Nail|"The target nail will be assessed by two dermatologists before treatment and at week 4, 8, 12, 16, 20, 24 using modified target NAPSI score (mtNAPSI, 0-96).~mtNAPSI evaluation: a target nail is divided into 4 quadrants and for each quadrant the nail parameters (oil drop, onycholysis, hyperkeratosis, hemorrhages, pitting, leukonychia, red spots on the lunula, and crumbling) are assessed separately: 0 = no sign, 1 = mild, 2 = moderate, and 3 = severe; the range of mtNAPSI is between 0 and 96, with higher score indicating more severe symptoms."|Baseline and 24 weeks||||units on a scale||Standard Deviation|Mean
2675481|NCT01445886|Primary|Change From Baseline in Single-handed Nail Psoriasis Severity Index (shNAPSI) at 24 Weeks|"The nails will be assessed by two dermatologists at baseline and after treatment 4, 8, 12, 16, 20, 24 weeks using single-handed Nail Psoriasis Severity Index (shNAPSI) score. shNAPSI evaluation: Each nail is given a score for nail bed psoriasis (0-4) and nail matrix psoriasis (0-4) , the total of which is the score for that nail (0-8); the range of shNAPSI of one hand is between 0 and 40, with higher score indicating more severe symptoms. Nail bed psoriasis: presence of any of the nail bed features (onycholysis, hemorrhages, hyperkeratosis, oil drop (salmon patch dyschroma): 0 for none, 1 for 1 quadrant only, 2 for 2 quadrants, 3 for 3 quadrants, and 4 for 4 quadrants. Nail matrix psoriasis: presence of any of the nail matrix features (pitting, leukonychia red spots in the lunula, crumbling): 0 for none, 1 if present in 1 quadrant of the nail, 2 if present in 2 quadrants of the nail, 3 if present in 3 quadrants of the nail, and 4 if present in 4 quadrants of the nail."|Baseline and 24 weeks||||units on a scale||Standard Deviation|Mean
2675482|NCT01445873|Secondary|Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Atrial Septostomy|Number of participants who received an atrial septostomy (balloon or blade) during hospitalization.|Day 1 to Month 6|FAS; N=number of participants with hospitalizations during follow-up period.|||participants|||Number
2675483|NCT01445873|Secondary|Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Heart/Lung Transplantation|Number of participants who received an heart/lung transplant during hospitalization.|Day 1 to Month 6|FAS; N=number of participants with hospitalizations during follow-up period.|||participants|||Number
2675484|NCT01445873|Secondary|Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Lung Transplantation|Number of participants who received an lung transplant during hospitalization.|Day 1 to Month 6|FAS; N=number of participants with hospitalizations during follow-up period.|||participants|||Number
2675485|NCT01445873|Secondary|Number of Hospitalizations|All hospitalizations during the follow-up period recorded in medical records.|Day 1 to Month 6|FAS|||hospitalizations||95% Confidence Interval|Mean
2675486|NCT01445873|Secondary|Other Pulmonary Arterial Hypertension (PAH)-Related Outcomes: Mortality|Number of participants who died during the follow-up period.|Day 1 to Month 6|FAS|||participants|||Number
2675487|NCT01445873|Secondary|Pulmonary Arterial Hypertension (PAH) Severity and Functional Status: Time to Clinical Worsening|Occurrence of any of the following: death, unplanned PAH-related hospitalization, initiation of epoprostenol, arterial septostomy, lung or heart/lung transplantation, ≥15% decrease from baseline in 6 minute walk test, signs/symptoms of right sided heart failure, and/or worsening WHO functional class.|Day 1 to Month 6|FAS|||months||Standard Deviation|Mean
2675488|NCT01445873|Secondary|Change From Baseline in Percent of Predicted Peak VO2|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with ≥ 1 value recorded during follow-up period.|||percent Vo2||95% Confidence Interval|Mean
2675489|NCT01445873|Secondary|Change From Baseline in Borg Dyspnoea Score|Borg dyspnoea scale is a 10-point scale where following scores stands for severity of dyspnoea: 0 (no breathlessness at all); 0.5 (very very slight [just noticeable]); 1 (very slight); 2 (slight breathlessness); 3 (moderate); 4 (some what severe); 5 (severe breathlessness); 7 (very severe breathlessness); 9 (very very severe [almost maximum] and 10 (maximum). Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with ≥ 1 value recorded during follow-up period.|||units on a scale||95% Confidence Interval|Mean
2675490|NCT01445873|Secondary|Change From Baseline in the Total Distance Walked During 6 Minute Walk Test (6MWT)|6MWT was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. Continuous pulse oximetry was conducted during the test for safety. Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and 1 value recorded during follow-up period.|||meters||95% Confidence Interval|Mean
2675491|NCT01445873|Secondary|Change From Baseline in Tricuspid Regurgitant Velocity|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and ≥ 1 follow-up value.|||m/sec||95% Confidence Interval|Mean
2675492|NCT01445873|Secondary|Change From Baseline in Tei Index|Difference between pre-index and follow-up value. Combined myocardial performance index calculated by adding isovolumic contraction time and isovolumic relaxation time and dividing the resulting sum by ejection time.|Baseline to Month 6|FAS; N=number of participants with pre-index and ≥ 1 follow-up value.|||ratio||95% Confidence Interval|Mean
2675493|NCT01445873|Secondary|Change From Baseline in Cardiac Output|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and follow-up value.|||L/min||95% Confidence Interval|Mean
2675494|NCT01445873|Secondary|Change From Baseline in Pulmonary Vascular Resistance|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and follow-up value.|||Dyn/s/cm5||95% Confidence Interval|Mean
2675495|NCT01445873|Secondary|Change From Baseline in Left Ventricular End Diastolic Pressure|Difference between pre-index and follow-up value.|Baseline to Month 6|Data not analyzed: no participants had pre-index and follow-up values for this outcome measure.|||mm Hg||95% Confidence Interval|Mean
2675497|NCT01445873|Secondary|Change From Baseline in Mean Pulmonary Artery Pressure|Difference between pre-index and follow-up value.|Baseline to Month 6|Data not analyzed: no participants had pre-index and follow-up values reported for this outcome measure.|||mm Hg||95% Confidence Interval|Mean
2675498|NCT01445873|Secondary|Change From Baseline in Mean Right Atrial Pressure|Difference between pre-index and follow-up value.|Baseline to Month 6|FAS; N=number of participants with pre-index and ≥ 1 value recorded during follow-up period.|||mm Hg||95% Confidence Interval|Mean
2675499|NCT01445873|Secondary|Change From Baseline in World Health Organization (WHO) Functional Class of Pulmonary Hypertension|Class I: no limitation of usual (usl) physical activity (PA); PA does not increase(d) (incr) dyspnea (dys), fatigue (ftg), chest pain (CP), or syncope (syn); Class II: mild limitation of usl PA; no discomfort at rest, but normal PA causes incr dys, ftg, CP, or presyncope (presyn); Class III: marked limitation of PA; no discomfort at rest but < ordinary activity causes incr dys, ftg, CP, or presyn; Class IV: unable to perform any PA at rest; may have signs of right ventricular failure; sys and/or ftg at rest and symptoms are incr by almost any PA.|Baseline to Month 6|FAS; N=number of participants with pre-index (prior to Thelin initiation) and ≥ 1 WHO value recorded during follow-up.|||participants|||Number
2675500|NCT01445873|Secondary|Use of Other Pulmonary Arterial Hypertension (PAH)-Related Medications|Use of PAH-related medications other than Thelin described by class of agent received.|Day 1 to Month 6|FAS|||percentage of participants|||Number
2675501|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Daily Dosage|Daily dosage of Thelin based on information in the medical record for the baseline visit and all follow-up clinic visits.|Day 1 to Month 6|FAS|||mg||95% Confidence Interval|Mean
2675502|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Numbers of Therapy-days Dispensed|Duration of Thelin therapy from initial receipt until date of discontinuation of thelin therapy or the end of follow-up, whichever occurred first.|Day 1 to Month 6|Not analyzed: duration of Thelin therapy as number of therapy days dispensed was not summarized; this measure was reported as duration in months only.|||days||Standard Deviation|Mean
2675503|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Duration|Duration of Thelin therapy based on time from index date (Day 1 of treatment) until the date of discontinuation of Thelin therapy.|Day 1 to Month 6|FAS; participants without evidence of discontinuation of Thelin therapy were censored at the end of follow-up (at 6 months or death if prior to 6 months).|||months||Standard Deviation|Mean
2675504|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Discontinuation|Participants were designated as having discontinued Thelin therapy if there was evidence in the medical records that treatment had been terminated.|Day 1 to Month 6|FAS|||participants|||Number
2675505|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Therapy Switching|Participants with evidence of discontinuation of Thelin therapy and evidence of receipt of another PAH-related therapy not previously received during the study period.|Day 1 to Month 6|FAS|||participants|||Number
2675506|NCT01445873|Primary|Patterns of Pharmacotherapy With Sitaxentan Sodium (Thelin): Mean Time to Therapy Augmentation|Participants still receiving Thelin with evidence of receipt of another PAH-related therapy (eg. bosentan, sildenafil) not previously received during the study period. Mean time in months to therapy augmentation.|Day 1 to Month 6|Full analysis set (FAS): participants with idiopathic pulmonary arterial hypertension (PAH) or PAH secondary to connective tissue disease, receipt of Thelin for treatment of PAH, 6 months of follow-up (except for death) after initial receipt (IR) of Thelin, and at least 1 clinic visit in medical record during 6-month period after IR of Thelin.|||months||Standard Deviation|Mean
2675507|NCT01445847|Primary|Number of Patients With Laryngospasm Postoperatively|"There were 4 scores of laryngospasm:~0 = No Laryngospasm~= Stridor or partial laryngospasm~= Complete Laryngospasm~= Cyanosis"|within first 15 minutes post‐dose|Trial was terminated by data monitoring committee due to safety concerns|||participants|||Number
2675508|NCT01445769|Other Pre-specified|Dose Distribution at Week 24|Average Daily Dose for the last 28 days on study.|Week 24|Intent-to-treat population: All enrolled participants.|||participants|||Number
2675509|NCT01445769|Secondary|Number of Participants With Grade 3 or Grade 4 Adverse Events||Baseline to the end of the study|Safety population: All participants who took at least 1 dose of study drug.|||participants|||Number
2675510|NCT01445769|Secondary|Median Percentage Change in Abdominal Symptom Scores at Week 24.|Symptoms of myelofibrosis were assessed using a symptom diary, the modified MFSAF v2.0. Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. The abdominal symptom score was the sum of 3 individual symptom scores (abdominal discomfort, pain under ribs on left side, and feeling of fullness [early satiety]).|Week 24|Intent-to-treat population: All enrolled participants. Note that three subjects did not have the Week 24 TSS; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 TSS assessment. Thus 39 subjects were analyzed.|||Percentage change||Full Range|Median
2675511|NCT01445769|Secondary|Mean Percentage Change in Abdominal Symptom Scores at Week 24.|Symptoms of myelofibrosis were assessed using a symptom diary, the modified MFSAF v2.0. Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. The abdominal symptom score was the sum of 3 individual symptom scores (abdominal discomfort, pain under ribs on left side, and feeling of fullness [early satiety]), each on a scale of 0 to 10. A higher score indicates worse symptoms. A negative change score indicates improvement. The Baseline abdominal symptom score was the mean of daily abdominal symptom scores from the last 7 consecutive days prior to the first study dose and ranged from 0 to 30. The Week 24 abdominal symptom score was the mean of the daily abdominal symptom scores from the last 28 consecutive days prior to the Week 24 visit and ranged from 0 to 30.|Week 24|Intent-to-treat population: All enrolled participants. Note that three subjects did not have the Week 24 TSS; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 TSS assessment. Thus 39 subjects were analyzed.|||Percentage change||Standard Deviation|Mean
2675706|NCT01444378|Secondary|Stent Integrity by X-ray|"Xrays were performed to evaluate stent integrity and to determine the presence of any stent fractures.~Grade of fracture as follows:~0 - No stent fracture(s) identified~- Single strut fracture only~- Multiple strut fractures~- Stent fracture with alignment~- Fracture out of alignment (≥ 2 segments)~- Spiral Fracture"|12 months|ITT population.|||percentage of participants|||Number
2675512|NCT01445769|Secondary|Percentage of Participants With Clinically Notable Anemia|Clinically Notable Anemia was a pre-specified safety parameter examined at Weeks 12, 18 and 24 and defined as: 1) New onset Grade 3 or higher anemia in subjects who are transfusion independent at Baseline, 2) New onset transfusion dependence in subjects who are transfusion independent at Baseline, defined as receipt of ≥ 2 units in ≤ a 12-week interval, 3) 50% increase in transfusions compared to Baseline in subjects who are transfusion dependent at Baseline.|Baseline to Weeks 12, 18 and 24|Safety population: All participants who took at least 1 dose of study drug.|||Percentage of participants|||Number
2675513|NCT01445769|Secondary|Percentage of Participants With a ≥ 50% Improvement From Baseline in Their Transfusion Status or With New Transfusion Independence Status for Those Participants Who Were Transfusion Dependent at Baseline|"Transfusion dependence at Baseline is defined as subjects who received ≥ 2 units of red blood cell product(s) in the 12 consecutive weeks prior to the date of first dose.~Transfusion independence On-Study is defined as subjects who received 0 units of red blood cell products over any 12-week period after starting dosing with ruxolitinib.~Improvement in transfusion dependence On-Study is defined as a 50% or greater reduction in the frequency of red blood cell transfusions over any 12-week period after starting dosing with ruxolitinib."|Baseline to Week 24|Intent-to-treat population: All enrolled participants who were transfusion dependent at baseline (n=15).|||Percentage of participants||95% Confidence Interval|Number
2675514|NCT01445769|Secondary|Median Percent Change From Baseline in Palpable Spleen Length at Week 24|Spleen length was assessed by manual palpation. The edge of the spleen was determined by palpation and measured in centimeters, using a soft ruler, from the costal margin to the point of greatest splenic protrusion.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that one subject had a non-palpable spleen at baseline, one subject did not have the Week 24 spleen palpation performed; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 spleen palpation. Thus 40 subjects were analyzed.|||Percentage change||Full Range|Median
2675515|NCT01445769|Secondary|Mean Percentage Change From Baseline in Palpable Spleen Length at Week 24|Spleen length was assessed by manual palpation. The edge of the spleen was determined by palpation and measured in centimeters, using a soft ruler, from the costal margin to the point of greatest splenic protrusion.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that one subject had a non-palpable spleen at baseline, one subject did not have the Week 24 spleen palpation performed; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 spleen palpation. Thus 40 subjects were analyzed.|||Percentage change||Standard Deviation|Mean
2675516|NCT01445769|Secondary|Percentage of Participants With a ≥ 50% Improvement From Baseline in Total Symptom Score at Week 24|Symptoms of myelofibrosis were assessed using a symptom diary, the modified MFSAF v2.0. Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. Symptoms assessed included night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), muscle/bone pain, and inactivity. The daily total symptom score was the sum of the first 6 individual symptom scores (each on a scale of 0-10). Inactivity was not included in the total score. The Baseline total symptom score was the mean of daily total symptom scores from the last 7 consecutive days prior to the first study dose and ranged from 0 to 60. The Week 24 total symptom score was the mean of the daily total symptom scores from the last 28 consecutive days prior to the Week 24 visit and ranged from 0 to 60. A higher score indicates worse symptoms. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All enrolled participants.|||Percentage of participants||95% Confidence Interval|Number
2675517|NCT01445769|Secondary|Percentage of Participants With a ≥ 10% Reduction From Baseline in Spleen Volume at Week 24|Spleen volume was measured using magnetic resonance imaging (MRI) or computed tomography (CT) scan. The MRIs were read in the central imaging laboratory. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the technique of least squares. MRI was the preferred method for obtaining spleen volume data. CT scans were performed if the participant was not a candidate for MRI. The CT scans were processed by the same central laboratory used for MRIs. The same method (MRI or CT) was used for all visits for a given participant unless a new contraindication to the use of MRI (eg, pacemaker insertion) occurred.|Baseline to Week 24|Intent-to-treat population: All enrolled participants.|||Percentage of participants||95% Confidence Interval|Number
2675518|NCT01445769|Secondary|Percentage of Participants With a ≥ 35% Reduction From Baseline in Spleen Volume at Week 24|Spleen volume was measured using magnetic resonance imaging (MRI) or computed tomography (CT) scan. The MRIs were read in the central imaging laboratory. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the technique of least squares. MRI was the preferred method for obtaining spleen volume data. CT scans were performed if the participant was not a candidate for MRI. The CT scans were processed by the same central laboratory used for MRIs. The same method (MRI or CT) was used for all visits for a given participant unless a new contraindication to the use of MRI (eg, pacemaker insertion) occurred.|Baseline to Week 24|Intent-to-treat population: All enrolled participants.|||Percentage of participants||95% Confidence Interval|Number
2675519|NCT01445769|Secondary|Median Percent Change From Baseline in the Total Symptom Score at Week 24|Symptoms of myelofibrosis were assessed using a symptom diary, the modified MFSAF v2.0. Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. Symptoms assessed included night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), muscle/bone pain, and inactivity. The daily TSS was the sum of the first 6 individual symptom scores (each on a scale of 0-10). Inactivity was not included in the total score. The Baseline total symptom score was the mean of daily total symptom scores from the last 7 consecutive days prior to the first study dose and ranged from 0 to 60. The Week 24 total symptom score was the mean of the daily total symptom scores from the last 28 consecutive days prior to the Week 24 visit and ranged from 0 to 60. A higher score indicates worse symptoms. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that 3 subjects did not have the Week 24 TSS; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 TSS assessment. Thus 39 subjects were analyzed.|||Percentage change||Full Range|Median
2675707|NCT01444378|Secondary|Maximum Walking Distance||12 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants|||Number
2675520|NCT01445769|Secondary|Mean Percentage Change From Baseline in the Total Symptom Score at Week 24|Symptoms of myelofibrosis were assessed using a symptom diary, the modified Myelofibrosis Symptom Assessment Form (MFSAF v2.0). Participants were issued a hand-held device to record answers to queries regarding 7 symptoms of myelofibrosis each night from Baseline through Week 24. Symptoms assessed included night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), muscle/bone pain, and inactivity. The daily total symptom score (TSS) was the sum of the first 6 individual symptom scores (each on a scale of 0-10). Inactivity was not included in the total score. The Baseline TSS was the mean of daily total symptom scores from the last 7 consecutive days prior to the first study dose and ranged from 0 to 60. The Week 24 TSS was the mean of the daily total symptom scores from the last 28 consecutive days prior to the Week 24 visit and ranged from 0 to 60. A higher score indicates worse symptoms. A negative change score indicates improvement.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that 3 subjects did not have the Week 24 TSS; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 TSS assessment. Thus 39 subjects were analyzed.|||Percentage change||Standard Deviation|Mean
2675521|NCT01445769|Primary|Median Percent Change From Baseline in Spleen Volume at Week 24|Spleen volume was measured using magnetic resonance imaging (MRI) or computed tomography (CT) scan. The MRIs were read in the central imaging laboratory. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the technique of least squares. MRI was the preferred method for obtaining spleen volume data. CT scans were performed if the participant was not a candidate for MRI. The CT scans were processed by the same central laboratory used for MRIs. The same method (MRI or CT) was used for all visits for a given participant unless a new contraindication to the use of MRI (eg, pacemaker insertion) occurred.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that 2 subjects did not have the Week 24 MRI; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 MRI. Thus 40 subjects were analyzed.|||: Percentage change||Full Range|Median
2675522|NCT01445769|Primary|Mean Percentage Change From Baseline in Spleen Volume at Week 24|Spleen volume was measured using magnetic resonance imaging (MRI) or computed tomography (CT) scan. The MRIs were read in the central imaging laboratory. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the technique of least squares. MRI was the preferred method for obtaining spleen volume data. CT scans were performed if the participant was not a candidate for MRI. The CT scans were processed by the same central laboratory used for MRIs. The same method (MRI or CT) was used for all visits for a given participant unless a new contraindication to the use of MRI (eg, pacemaker insertion) occurred.|Baseline to Week 24|Intent-to-treat population: All enrolled participants. Note that 2 subjects did not have the Week 24 MRI; one subject dropped out for disease progression and two withdrew consent prior to the Week 24 MRI. Thus 40 subjects were analyzed.|||Percentage change||Standard Deviation|Mean
2675523|NCT01445678|Secondary|The Percentage of Subjects With Clinical Response at LFU Visit in the ME Population|Clinical response is clinical cure at TOC and no signs and symptoms recur or worsen since the TOC visit|LFU; 38 to 45 days after first study drug administration|Microbiologically evaluable: Treated patients, complied with protocol, with pathogens susceptible to study drug.|||percentage of subjects|||Number
2675524|NCT01445678|Secondary|The Percentage of Subjects With Clinical Response at Long Term Follow-Up (LFU) in the MITT Population|Clinical response is clinical cure at TOC and no signs and symptoms recur or worsen since the TOC visit.|LFU; 38 to 45 days after first study drug administration|MITT: Randomized patients, with baseline pathogen.|||percentage of subjects|||Number
2675525|NCT01445678|Secondary|The Percentage of Subjects With Clinical Response at End of Therapy in the ME Population|Clinical response is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.|EOT; Within 24 hours of last study drug administration|Microbiologically evaluable: Treated patients, complied with protocol, with pathogens susceptible to study drug.|||percentage of subjects|||Number
2675526|NCT01445678|Secondary|The Percentage of Subjects With Clinical Response at End of Therapy (EOT) Visit in the MITT Population|Clinical response is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.|EOT; Within 24 hours of last study drug administration|MITT: Microbiological Intent-to-Treat: Randomized patients, with baseline pathogen.|||percentage of subjects|||Number
2675527|NCT01445678|Secondary|The Percentage of Subjects With Microbiological Outcome of Success at the TOC Visit in the Microbiologically Evaluable (ME) Population|Success is eradication (absence of the baseline pathogen in a specimen appropriately obtained from the original site of infection) or presumed eradication (absence of material to culture in a subject who was assessed as a clinical cure) for each baseline pathogen|TOC; 26-30 days after start of study drug administration|Microbiologically evaluable: Treated patients, complied with protocol, with pathogens susceptible to study drug.|||percentage of subjects|||Number
2675528|NCT01445678|Primary|The Percentage of Subjects With Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population|Clinical cure is complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.|TOC; 26-30 days after start of study drug administration|MITT: Randomized patients, with baseline pathogen.|||percentage of subjects|||Number
2675529|NCT01445652|Primary|Subjective Vision With Correction Type|"Participant responded to an SMS message: Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]."|Month 6|This reporting group includes all participants who sent in an SMS response.|||Units on a scale||Standard Deviation|Mean
2675530|NCT01445652|Primary|Subjective Happiness With Correction Type|"Participant responded to an SMS message: Please rate your happiness (H) and vision (V) with your [contact lenses/spectacles]: 1=very poor; 2=poor; 3=neither; 4=good; and 5=very good. eg H2V4. Please send N if in you are not wearing [contact lenses/spectacles]."|Month 6|This reporting group includes all participants who sent in an SMS response.|||Units on a Scale||Standard Deviation|Mean
2675531|NCT01445626|Secondary|Time to Improvement of 3 Lines or More in BCVA|Time to improvement of 3 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 3 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best).|Baseline, Up to 12 months|All participants with data available for analysis.|||Days||Full Range|Median
2675532|NCT01445626|Secondary|Time to Improvement of 2 Lines or More in BCVA|Time to improvement of 2 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 2 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best).|Baseline, Up to 12 months|All participants with data available for analysis.|||Days||Full Range|Median
2675533|NCT01445626|Secondary|Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last Injection|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and 7 to 12 weeks after the last injection. A negative change from baseline indicates improvement.|Baseline, 7 to 12 weeks following the last injection|All participants with data available for analysis.|||µm||Standard Deviation|Mean
2675534|NCT01445626|Secondary|Percentage of Patients With an Increase of 3 Lines or More in BCVA|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement.|Baseline, Up to 12 months|All treated participants.|||Percentage of participants|||Number
2675535|NCT01445626|Secondary|Percentage of Patients With an Increase of 2 Lines or More in BCVA|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement.|Baseline, Up to 12 months|All treated participants.|||Percentage of participants|||Number
2675536|NCT01445626|Secondary|Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of letters ranging from 0 (worse) to 100 (best). The change in BCVA was calculated using the most improved number of letters read correctly between 7 and 12 weeks following the last injection of OZURDEX® - the number of letters read correctly at baseline. A positive change from baseline indicates improvement.|Baseline, 7 to 12 weeks following the last injection|All participants with data available for analysis.|||Letters||Standard Deviation|Mean
2675537|NCT01445626|Primary|Time to OZURDEX® Re-injection|Time to OZURDEX® re-injection is the time in days between the first and second OZURDEX® injections.|Up to 12 months|All participants with data available for analysis.|||Days||Standard Deviation|Mean
2675538|NCT01445613|Secondary|Clinical Success|Clinical success is defined as the attainment of < 50% residual stenosis of the target lesion and absence of a death or stroke 30-day post-procedure.|30 days|FAS population|||percentage of participants||95% Confidence Interval|Number
2675539|NCT01445613|Secondary|Freedom From Clinically Driven Target Lesion Revascularization|Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion.|365 days|FAS population|||percentage of participants|||Number
2675540|NCT01445613|Secondary|Freedom From Clinically Driven Target Lesion Revascularization|Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion.|180 days|FAS population|||percentage of participants|||Number
2675541|NCT01445613|Secondary|Freedom From Clinically Driven Target Lesion Revascularization|Target Lesion Revascularization (TLR) is designated as clinically driven if the subject has recurring symptoms or has become newly symptomatic and has stenosis >50% in the stented lesion, or is asymptomatic and has a stenosis of >80% in the stented lesion.|30 days|FAS population|||percentage of participants|||Number
2675542|NCT01445613|Secondary|Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age||365 days|FAS population|||percentage of participants|||Number
2675543|NCT01445613|Secondary|Composite of Peri-procedural Death and Stroke by Age||30 days|FAS population. The number of participants analyzed includes subjects with data available at that time frame.|||percentage of participants||95% Confidence Interval|Number
2675544|NCT01445613|Secondary|Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status||365 days|FAS population|||percentage of participants|||Number
2675545|NCT01445613|Secondary|Composite of Peri-procedural Death and Stroke by Symptomatic Status||30 days|FAS population|||percentage of participants||95% Confidence Interval|Number
2675546|NCT01445613|Primary|Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days||365 days|FAS population|||percentage of participants|||Number
2675547|NCT01445613|Secondary|Death and All Stroke||30 Days|FAS population. The number of participants analyzed includes subjects with data available at that time frame.|||percentage of participants||95% Confidence Interval|Number
2675548|NCT01445613|Primary|Composite Rate of Peri-procedural (Within 30 Days of the Procedure) Death and Stroke, Plus Ipsilateral Stroke Between Day 31 and 1 Year (365 Days)||0 to 365 days|FAS population|||percentage of participants||Standard Error|Mean
2675549|NCT01445548|Secondary|Development of Exudative Age-Related Macular Degeneration (AMD) as Measured by Optical Coherence Tomography (OCT) at 12 Months Compared to Baseline||Baseline and 12 Months|Zero participants were analyzed because no data were collected to analyze this outcome as no study or fellow eye developed neovascular changes during the study.||||||
2675602|NCT01444898|Primary|Appetite Scores|"Appetite scores using a syndrome-validated hyperphagia questionnaire~11 item questionnaire divided into subcategories of behavior (5 questions), drive (4 questions), severity (2 questions). Tallied and analyzed as total and subcategory scores. Each question scored 1-5 with higher scores correlating with worse hyperphagia.~Possible ranges: Total 11-55, behavior 5-25, drive 4-20, severity 2-10"|6 months||||units on a scale||Standard Deviation|Mean
2675550|NCT01445548|Secondary|Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||Ratio|Eyes|Standard Deviation|Mean
2675551|NCT01445548|Secondary|Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||Ratio|Eyes|Standard Deviation|Mean
2675552|NCT01445548|Secondary|Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||Ratio|Eyes|Standard Deviation|Mean
2675553|NCT01445548|Secondary|Relative Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12||||Ratio|Eyes|Standard Deviation|Mean
2675554|NCT01445548|Secondary|Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss.The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||mm^2|Eyes|Standard Deviation|Mean
2675555|NCT01445548|Secondary|Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Confocal Scanning Laser Ophthalmoscope (SLO), in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a SLO by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||mm^2|Eyes|Standard Deviation|Mean
2675556|NCT01445548|Secondary|Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||mm^2|Eyes|Standard Deviation|Mean
2675557|NCT01445548|Secondary|Absolute Change in Area of GA, as Measured by Fundus Autofluorescence (FAF) Imaging Using a Modified Fundus Camera (mFC), in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for FAF images obtained with a mFC by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||mm^2|Eyes|Standard Deviation|Mean
2675558|NCT01445548|Secondary|Absolute Change in Drusen Area Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.|"The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 3 had drusen area graded at 12 months.|||MPS DA|Eyes|Standard Deviation|Mean
2675559|NCT01445548|Secondary|Absolute Change in Drusen Area Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.|"The total area occupied by drusen was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~One Macular Photocoagulation Study Disc Area (MPS DA) is equivalent to 1.77 mm^2 on the retina."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 3 had drusen area graded at 12 months.|||MPS DA|Eyes|Standard Deviation|Mean
2675560|NCT01445548|Secondary|Relative Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12||||Ratio||Standard Deviation|Mean
2675561|NCT01445548|Secondary|Relative Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by dividing the absolute change in the total area of GA in the study eye at 12 months by the baseline value."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||Ratio||Standard Deviation|Mean
2675562|NCT01445548|Secondary|Absolute Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||mm^2|Eyes|Standard Deviation|Mean
2675563|NCT01445548|Secondary|Absolute Change in Total Area of Macular GA, Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.|"Geographic atrophy (GA) is the death of photoreceptors and surrounding cells in the retina. The death of these photoreceptors results in lesions that cause vision loss. The area of GA was determined using planimetry for color stereoscopic fundus images by masked graders at the Doheny Image Reading Center (University of Southern California, Los Angeles, CA).~This outcome measure was calculated by subtracting the GA value for the study eye at baseline from the GA value for the study eye at Month 12."|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||mm^2|Eyes|Standard Deviation|Mean
2675564|NCT01445548|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Fellow Eye at 12 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. One eye (the study eye) was initially randomized to receive intravitreal sirolimus and the fellow eye was observed as the control.|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||ETDRS letters|Eyes|Standard Deviation|Mean
2675565|NCT01445548|Secondary|Changes in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. One eye (the study eye) was initially randomized to receive intravitreal sirolimus and the fellow eye was observed as the control.|Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||ETDRS letters|Eyes|Standard Deviation|Mean
2675566|NCT01445548|Primary|Rate of Change in Area of Geographic Atrophy (GA), Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Fellow Eye at 12 Months Compared to Baseline.||Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||mm^2/month|Eyes|Standard Deviation|Mean
2675567|NCT01445548|Primary|Rate of Change in Area of Geographic Atrophy (GA), Based on Masked, Digital Grading of Fundus Photography by an External Reading Center, in the Study Eye at 12 Months Compared to Baseline.||Baseline and Month 12|The analysis was intention-to-treat (ITT). Although 6 participants were enrolled, only 5 were followed for 12 months.|||mm^2/month|Eyes|Standard Deviation|Mean
2675568|NCT01445301|Secondary|Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12|Burning/stinging, itching were evaluated independently by the participant on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12).|Baseline (Day 1) and Week 1, 2, 4, 8 and 12|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X. X, X in the category titles).|||Score on scale||Standard Deviation|Mean
2675603|NCT01444898|Primary|Change in Pancreatic Peptide (PP)||6 months||||pg ml^-1||Standard Deviation|Mean
2675604|NCT01444898|Primary|Change in Acy Ghr||6 months||||pg ml^-1||Standard Deviation|Mean
2675605|NCT01444898|Primary|Change in Leptin||6 months||||ng ml^-1||Standard Deviation|Mean
2675569|NCT01445301|Secondary|Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12|Erythema (redness), dryness, and peeling, were evaluated independently by the investigator on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12).|Baseline (Day 1) and Week 1, 2, 4, 8, and 12|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles).|||Score on scale||Standard Deviation|Mean
2675570|NCT01445301|Secondary|Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX)|MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism). MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism) for the susceptibility of clinical isolates (Propionibacterium acnes before and after application of the CLDM and NDFX was reported. MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis.|Baseline (Day 1) and Week12|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles).|||Micrograms/milliliter|||Number
2675571|NCT01445301|Secondary|Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions|The percentage of participants who had reduction in total lesions (inflammatory and non-inflammatory) of at least 50 percent from Baseline at Weeks 1, 2, 4, 8, and 12 was measured.|Baseline (Day 1) and Week 1, 2, 4, 8, and 12|ITT population. Only those participants available at the indicated time points were analyzed.|||Percentage of participants||95% Confidence Interval|Number
2675572|NCT01445301|Secondary|Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12|Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5 (very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face.|Week 1, 2, 4, 8, and 12|ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles).|||Percentage of participants||95% Confidence Interval|Number
2675573|NCT01445301|Secondary|Percentage of Participants With a Minimum 2-grade Improvement From Baseline to Week 12 in Investigator's Static Global Assessment (ISGA) Score|Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5(very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face.|Baseline (Day 1) and Week 12|ITT population. Only those participants available at the indicated time points were analyzed.|||Percentage of Participants||95% Confidence Interval|Number
2675574|NCT01445301|Secondary|Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts|The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.( Weeks 1, 2, 4, 8 and 12)|Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12|ITT population. Only those participants available at the specified time points were analyzed.|||Percent change||Standard Error|Least Squares Mean
2675575|NCT01445301|Secondary|Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts|The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.|Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12|ITT population. Only those participants available at the specified time points were analyzed.|||Lesion count||Standard Error|Least Squares Mean
2675606|NCT01444898|Primary|Change in Insulin Levels||6 months||||u/U ml^-1||Standard Deviation|Mean
2675607|NCT01444898|Primary|Change in HbA1c (%)||6 months||||percentage||Standard Deviation|Mean
2675608|NCT01444898|Primary|Change in BMI Z-Score||6 months||||units on a scale||Standard Deviation|Mean
2675576|NCT01445301|Secondary|Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts|The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.|Baseline (Day 1) and Weeks 1, 2, 4, and 8|ITT population. Only those participants available at the specified time points were analyzed.|||lesion count||Standard Deviation|Mean
2675577|NCT01445301|Primary|Absolute Change From Baseline to Week 12 in Total Lesion Counts.|The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from post-randomization value at Week 12.|Baseline (Day 1) and Week 12|ITT population. Only those participants available at the indicated time points were analyzed.|||lesion count||Standard Error|Least Squares Mean
2675578|NCT01445171|Other Pre-specified|Subject's Average Serum LDH Measurement Over Time.|The lactate dehydrogenase (LDH) test looks for signs of damage to the body's tissues.|Baseline, 3 Months, 1 Year, and 5 Years post-implant|The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.|||U/L||Standard Deviation|Mean
2675579|NCT01445171|Other Pre-specified|Subject's Average Haptoglobin Measurement Over Time.|Laboratory Analysis of Haptoglobin on blood drawn from subjects; Haptoglobin is a protein produced by the liver.|Baseline, 3 Months, 1 Year, and 5 Years post-implant|The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.|||g/L||Standard Deviation|Mean
2675580|NCT01445171|Other Pre-specified|Subject's Average Reticulocytes Percentage Over Time.|Reticulocytes are immature red blood cells; a reticulocyte blood test measures the amount of these cells in the blood.|Baseline, 3 Months, 1 Year, and 5 Years post-implant|The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.|||percentage of reticulocytes||Standard Deviation|Mean
2675581|NCT01445171|Other Pre-specified|Subject's Average Platelet Count Over Time.|Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.|Baseline, 3 Months, 1 Year, and 5 Years post-implant|The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.|||10^3 platelets per microliter||Standard Deviation|Mean
2675582|NCT01445171|Other Pre-specified|Subject's Average Hematocrit Percentage Over Time.|Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component (plasma) in the blood.|Baseline, 3 Months, 1 Year, and 5 Years post-implant|The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.|||percentage of red blood cells||Standard Deviation|Mean
2675583|NCT01445171|Other Pre-specified|Subject's Average Hemoglobin Count Over Time.|Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.|Baseline, 3 Months, 1 Year, and 5 Years post-implant|The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.|||g/dl||Standard Deviation|Mean
2675584|NCT01445171|Other Pre-specified|Subject's Average Red Blood Cells Count Over Time.|Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.|Baseline, 3 Months, 1 Year, and 5 Years post-implant|The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.|||10^6 cells/microliters||Standard Deviation|Mean
2675585|NCT01445171|Other Pre-specified|Subject's Average White Blood Cell Count Measurement Over Time.|Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.|Baseline, 3 Months, 1 Year, and 5 Years post-implant|The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.|||10^3 cells/microliters||Standard Deviation|Mean
2675586|NCT01445171|Other Pre-specified|Subject's Amount of Aortic Valvular Regurgitation Over Time|Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.|Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.|||Participants|||Count of Participants
2675587|NCT01445171|Other Pre-specified|Subject's Average Effective Orifice Area Measurements Over Time.|Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.|Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.|||Centimeters Squared||Standard Deviation|Mean
2675663|NCT01444378|Secondary|Quality of Life Measures : Physical Component Summary (PCS)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675588|NCT01445171|Other Pre-specified|Subject's Average Mean Systolic Gradient Measurements Over Time.|Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.|Discharge (an average of 13 days), 1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.|||mmHg||Standard Deviation|Mean
2675589|NCT01445171|Other Pre-specified|Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time|The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.|Baseline, 3 Months, and 1 Year post-implant|The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.|||units on a scale||Standard Deviation|Mean
2675590|NCT01445171|Other Pre-specified|Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline|"The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.~Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).~Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).~Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.~Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases."|1 Month, 3 Months, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant|The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.|||Participants|||Count of Participants
2675591|NCT01445171|Other Pre-specified|Number of Subject's With Procedural Success|Procedure success is defined as device technical success followed by the absence of adverse events requiring device reoperation, requiring implantation of permanent pacemaker, or subject death.|Discharge(an average of 13 days) or 10 days post-implant, whichever comes first|This outcome is reported for enrolled subjects where data is available. Subjects were considered enrolled after meeting all the enrollment criteria, signing the informed consent, and after the surgeon sized the aortic annulus, and determined that the bioprosthesis could be implanted.|||Participants|||Count of Participants
2675592|NCT01445171|Other Pre-specified|Number of Subject's With Device Technical Success|Device technical success is defined as the successful delivery and deployment of one bioprosthesis with one delivery system with a maximum of two attempts.|At time of surgery, an average of 3 hours|This outcome is reported for enrolled subjects where data is available. Subjects were considered enrolled after meeting all the enrollment criteria, signing the informed consent, and after the surgeon sized the aortic annulus, and determined that the bioprosthesis could be implanted.|||Participants|||Count of Participants
2675593|NCT01445171|Primary|Percent of Late Adverse Events|Number of late adverse events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).|Events occurring >= 31 days and up through 5 years post-implant|The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.|||Percentage of late adverse events|||Number
2675594|NCT01445171|Primary|Percent of Early Adverse Events|Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100.|Events occuring within 30 days of procedure|The outcome is reported for subjects who received the Edwards Intuity model 8300ACA or 8300ACB device where data is available.|||Percentage of subjects|||Number
2675595|NCT01445028|Primary|Rate of Retinal Attachment|We will evaluate all patients for retinal attachment at 3 months.|3 months||||Participants|||Count of Participants
2675596|NCT01444924|Secondary|Pain Scores|Pain scores by the Visual Analog Scale (VAS) [0-5, where 0 is no pain and 5 is extreme] and Wisconsin Brief Pain Inventory (BPI) [where 0 is no pain and 10 is the most painful], will be collected 3 times post-operatively (once the day of surgery (at least 2 hours post-op) and both the morning and afternoon/evening on post-operative day #1). Pain scores will be analyzed individually using the chi-squared test and linear regression. All statistical calculations used a two-sided significance level of 0.05 and were calculated using the R Project for Statistical Computing. VAS and BPI scores for each subject were averaged to provide a resultant VAS and BPI score.|from 2 hours post-op to the afternoon/evening of post-op day #1||||units on a scale||95% Confidence Interval|Mean
2675597|NCT01444924|Primary|24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents||24 hours||||mg||Standard Deviation|Mean
2675598|NCT01444911|Secondary|Vaginal Length|Change in vaginal length as measured from baseline to 6 months.|At baseline and 6 months||||Centimeters||Full Range|Mean
2675599|NCT01444911|Secondary|FACT-G Score|The FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire assesses general cancer quality-of-life measure for evaluating patients receiving cancer treatment. Scores range from 0 to 108, where 0 is low well-being and 108 is the highest well-being possible. Difference in score from baseline to 6 months is reported.|At baseline and 6 months||||units on a scale||Full Range|Mean
2675600|NCT01444911|Secondary|Change in Marinoff Scale at 6 Months|"The Marinoff dyspareunia scale measures pain with intercourse, measured from 0-3, according to the following scale:~0 = no pain with intercourse~= pain with intercourse that doesn't prevent the completion~= pain with intercourse requiring interruption or discontinuance~= pain with intercourse preventing any intercourse~Difference in Marinoff scores reported, value at 6 months minus value at baseline."|At baseline and 6 months|Data for eleven subjects (2 from Standard of Care and 9 from VRP) was not collected at one or more study visits, and the change in scores could not be calculated.|||units on a scale||Full Range|Mean
2675601|NCT01444911|Primary|Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months|Female Sexual Function Index (FSFI), uses a 19-item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported.|At baseline and 6 months||||Units on a scale||Full Range|Mean
2675609|NCT01444898|Primary|% Change in Body Mass Index (BMI)|Prior to analysis, distributions were evaluated for normality and natural log transformation was performed to analyse data not normally distributed. Data are presented as mean ±SD unless not normally distributed, in which case they are presented as median with intra-quartile ranges (25th and 75th percentiles). Within-subject changes between visits were analysed by mixed model repeated measures. When the overall F-test for difference among visits was significant, Dunnett-adjusted pairwise comparisons were made between baseline and each subsequent visit.|6 months||||% change in BMI||Standard Deviation|Mean
2675610|NCT01444898|Primary|Change in Weight|Change in weight (kg) after 6 months of treatment with study drug. Described as mean +/- SD|6 months||||kg||Standard Deviation|Mean
2675611|NCT01444781|Secondary|Number of Participants Reporting a Solicited Injection Site Following Booster Vaccination With Prevenar Vaccine|Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Grade 3 Injection site: Pain, cries if limb is moved or reduced movement; Erythema and Swelling, ≥5 cm; and Extensive swelling of limb, Severe.|Day 0 up to Day 7 after final booster vaccination|Solicited injection site reactions were assessed in the Safety Analysis Set.|||Participants|||Number
2675612|NCT01444781|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|Solicited injection site: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb; Solicited systemic reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 Injection site: Pain, Cries if limb is moved or reduced movement; Erythema and Swelling, ≥5 cm; Extensive swelling of limb, Severe. Grade 3 Systemic reactions: Pyrexia (Temperature) >39.5˚C; Vomiting, ≥ 6 times per 24 hours or needing parenteral nutrition; Crying, >3 hours; Somnolence, Sleeping often or difficulty waking; Anorexia, refuses ≥3 meals; and Irritability, Inconsolable.|Day 0 up to Day 7 after final booster vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set, which includes all persons who received the study or control vaccine.|||Participants|||Number
2675613|NCT01444781|Secondary|Summary of Geometric Mean Titers to Vaccine Antigens After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine by Age Strata|Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay.|Day 30 after final booster vaccination|Geometric mean titers to vaccine antigens were assessed in the Per Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2675614|NCT01444781|Secondary|Summary of Booster Response to Vaccine Antigens Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine By Age Strata|Anti-PT and anti-FHA antibodies were measured by ELISA.|Day 0 (pre-vaccination) and Day 30 after final booster vaccination|Booster responses to vaccine antigens were assessed in the Per Protocol Analysis Set.|||Participants|||Number
2675615|NCT01444781|Secondary|Summary of Geometric Mean Titers to Prevenar Vaccine Antibodies After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA.|Day 30 after final booster vaccination|Geometric mean titers against Prevenar vaccine serotypes were assessed in the Per Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2675616|NCT01444781|Secondary|Summary of Immune Response Against Serotypes in the Prevenar Vaccine After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|Anti-Streptococcus pneumococcal type specific antibody (anti-Pn PS) was measured by ELISA. Booster response to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F was defined as antibody titers ≥0.35 µg/mL at Day 30.|Day 30 after final booster vaccination|Antibody responses against Prevenar vaccine serotypes were assessed in the Per-protocol Analysis Set.|||Participants|||Number
2675617|NCT01444781|Secondary|Summary of Geometric Mean Titers to Vaccine Antibodies Post Primary Vaccination Series; Before and After Booster Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine.|"Anti-Diphtheria antibodies were measured by a toxin neutralization test. Anti-Tetanus, anti-PT, and anti-FHA antibodies were measured by ELISA. Anti-Poliovirus types 1, 2, and 3 were measured by neutralization assay. Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-PRP antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker).~Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers."|Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination|Geometric mean titers against vaccine antibodies were assessed in the Per Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2675618|NCT01444781|Primary|Summary of Hepatitis B and Haemophilus Influenzae Type B Post Primary Series Antibodies; Antibody Persistence, and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|"Anti-Hepatitis B antibodies were measured by the commercially available VITROS ECi/ECiQ Immunodiagnostic System. Anti-Haemophilus influenza type b capsular polyribosyl ribitol phosphate (PRP) antibodies were measured using a Farr type radioimmunoassay that used radiolabeled PRP (3H PRP) in the presence of 36Cl (volume marker). Anti-Hepatitis antibody titers ≥ 10 mIU/mL and ≥ 100 mIU/mL at Day 0 confirmed antibody persistence and booster response at Day 30. Anti-PRP antibody titers ≥ 0.15 µg/ml and ≥ 1.0 µg/ml at Day 0 confirmed antibody persistence and booster response at Day 30.~Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers."|Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination|Antibody responses were assessed in the Per Protocol Analysis Set.|||Participants|||Number
2675619|NCT01444781|Primary|Summary of Polio Antibodies Post Primary Series, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|"Anti-Poliovirus types 1, 2, and 3 antibodies were measured by neutralization assay. Antibody persistence for anti-Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) before the booster dose at Day 0. Booster response to Poliovirus 1, 2, and 3 was defined as antibody titers ≥8 (1/dil) at Day 30.~Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers."|Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination|Antibody responses were assessed in the Per Protocol Analysis Set.|||Participants|||Number
2675708|NCT01444378|Secondary|Maximum Walking Distance||6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants|||Number
2675620|NCT01444781|Primary|Summary of Pertussis and Filamentous Haemagglutinin Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine or Infanrix Hexa Vaccine|"Anti-Pertussis toxin (PT) and anti-Filamentous haemagglutinin (FHA) antibodies were measured by ELISA. Antibody persistence for anti-PT and anti-FHA was defined as titers ≥ lower limit of quantitation (LLOQ) before the booster dose at Day 0. Booster responses for PT and FHA at Day 30 were defined as: pre-vaccination antibody concentrations < LLOQ and post-vaccination levels ≥ 4 x LLOQ, pre-vaccination antibody concentrations ≥ LLOQ but < 4 x LLOQ and post/pre vaccination ≥ 4, and pre-vaccination antibody concentrations ≥ 4 x LLOQ and post/pre-vaccination ≥ 2.~Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers."|Day 140 after primary vaccination, Day 0 (pre-vaccination), and Day 30 after final booster vaccination|Antibody responses were assessed in the Per-protocol Analysis Set.|||Participants|||Number
2675621|NCT01444781|Primary|Summary of Diphtheria and Tetanus Post Primary Series Antibodies, Persistence and Booster Response Following Vaccination With Either DTaP-IPV Hep B-PRP T Vaccine or Infanrix Hexa Vaccine|"Anti-Diphtheria (D) antibodies were measured by a toxin neutralization test. Anti-Tetanus (T) antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Antibody persistence for anti-Diphtheria and anti-Tetanus antibodies was defined as titers ≥0.01 IU/mL and ≥0.1 IU/mL before the booster dose at Day 0. Booster response to Diphtheria and Tetanus was defined as antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL at Day 30 post-booster vaccination.~Day 140 = Primary series; Day 0 = Pre-booster; and Day 30 = Post-booster titers"|Day 140 (Primary series) and Day 0 (Pre-booster)|Antibody responses were assessed in the Per Protocol Analysis Set, which includes all persons who did not have any protocol deviations.|||Participants|||Number
2675622|NCT01444742|Secondary|Overall Survival (OS)|Overall survival defined as the time interval from study entry date to the date of death due to any cause, measured in days/months. Bayesian time-to-event model used to monitor overall survival.|5 years||||Months||Full Range|Median
2675623|NCT01444742|Primary|Number of Participants With Complete Response (CR)|Complete Response Criteria (CR must last for at least 4 weeks): Marrow: </= 5% myeloblasts with normal maturation of all cell lines; Persistent dysplasia noted; Blood: Hemoglobin (Hb) >/= 11 g/dL (untransfused, patient not on EPO); Neutrophils >/= 1x109/L (not on myeloid growth factor); Platelets >/= 100 * 109/L (not on thrombopoietic agent); No blasts. Bone marrow aspirate and/or biopsy at the end of course 1 (day 28 +/- 7 days). The method of Thall, Simon, and Estey used to monitor response.|4 weeks after first cycle|One of the eighty-one participants registered on the study were in evaluable for response.|||Participants|||Count of Participants
2675624|NCT01444651|Secondary|Baseline to 3-month Change in Matsuda Disposition Index|Change in disposition index from baseline to 3 months. This index is a composite measure thought to reflect insulin resistance and secretion. Matsuda disposition index = [Matsuda sensitivity index * insulinogenic index]|Baseline and 3 months||||unitless index||Standard Deviation|Mean
2675625|NCT01444651|Secondary|Baseline to 3 Month Change in Composite of Insulin Resistance and Sensitivity, as Measured by the Oral Disposition Index|The secondary endpoint is defined as the treatment group difference in the change in oral disposition index (baseline minus 3-month). This is thought to reflect a composite of both insulin resistance and secretion. Oral disposition index = insulinogenic index / fasting insulin|Baseline and 3 months||||unitless index||Standard Deviation|Mean
2675626|NCT01444651|Secondary|Insulinogenic Index|The secondary endpoint is defined as the treatment group difference in the change in insulinogenic index (baseline minus 3-month). This index is thought to reflect insulin secretion, and is derived from fasting and 30 min-post oral glucose tolerance testing glucose and insulin values. Insulinogenic index = [fasting insulin - insulin at time 30 min] / [fasting glucose - glucose at time 30 min]|Baseline and 3 months||||unitless index||Standard Deviation|Mean
2675627|NCT01444651|Secondary|Baseline to 3-month Change in Endothelial Function Measured by EndoPAT|Endothelial function was measured using the reactive hyperemia index, acquired using EndoPAT device. Peripheral arterial tonometry probes were placed on both index fingers. After a 5 min equilibration period, a blood pressure cuff was inflated to 200 mmHg and kept inflated for 5 min. The cuff was then rapidly deflated and the reactive hyperemic response pulse volume recorded, where RHI = ratio of hyperemic finger pulse volume (post-cuff inflation / pre-cuff inflation) to control finger pulse volume (post-cuff inflation / pre-cuff inflation)|Baseline and 3 months||||unitless index||Standard Deviation|Mean
2675628|NCT01444651|Secondary|Baseline to 3-month Change in Insulin Sensitivity, as Measured by the Matsuda Index|The secondary endpoint is defined as the treatment group difference in the change in Matsuda Index (baseline minus 3-month). This index is a measure of insulin resistance derived from a frequently sampled oral glucose tolerance test, obtaining glucose and insulin levels in the fasting state, as well as 30, 60, 90, and 120 min after administration of oral glucose load. Matsuda index = 10,000/SQRT [fasting glucose*fasting insulin* (mean glucose from time 30, 60, 90, 120 min) * (mean insulin at time 30, 60, 90, and 120 min)]|Baseline and 3 months||||unitless index||Standard Deviation|Mean
2675629|NCT01444651|Primary|Change in Insulin Resistance From Baseline to 3 Months, as Measured by HOMA-IR|The primary endpoint is defined as the treatment group difference in the change in insulin resistance (baseline HOMA-IR minus 3-month HOMA-IR). HOMA-IR = [fasting glucose * fasting insulin]/405|Baseline and 3 months||||mg*microunits/dL*mL||Standard Deviation|Mean
2675630|NCT01444456|Secondary|Percentage of Participants With Increase in Hemoglobin ≥ 1 g/dL at Any Time|The percentage of participants with increase in hemoglobin (≥ 1 g/dL) at any time from Day 2 until the end-of-study assessment (Week 13).|From Baseline to Week 13|Primary analysis set|||percentage of participants|||Number
2675638|NCT01444430|Secondary|Asthma Control Questionnaire (ACQ6)|"The outcome variable for ACQ6 was the difference between the average of values recorded during the treatment period (day 28, day 84 and day 182) and the baseline measure. Analysis of covariance (ANCOVA) model, including the fixed factors of treatment and strata by incoming control/asthma treatment and baseline ACQ6 as covariate was used to compare Symbicort and budesonide.~The asthma control questionnaire, ACQ6, consists of six questions; all assessed on a 7-point scale from 0 to 6, where 0 represents good control and 6 represents poor control. The overall score is the mean of the responses to each of the six questions."|baseline, day 28, day 84, day 182|Full analysis set (FAS) population comprised of all patients randomized to study drug with at least one post-baseline ACQ6 score.|||ACQ6 overall score change from baseline||Standard Error|Least Squares Mean
2675631|NCT01444456|Secondary|Percentage of Participants With Improvement in Patient-perceived Fatigue (PPF) at Any Time|"The percentage of participants with iimprovement in PPF at any time from Day 2 until the end-of-study assessment (Week 13). Improvement in PPF was defined as improvement in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference [MID]). The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the FACT-An questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for Not at all to 4 for Very much. Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue)."|From Baseline to Week 13|Primary analysis set|||percentage of participants|||Number
2675632|NCT01444456|Secondary|Time to First Increase in Hemoglobin|Time from Baseline to first increase in hemoglobin of ≥ 1 g/dL|From Baseline until Week 9|Primary analysis set|||days||95% Confidence Interval|Median
2675633|NCT01444456|Secondary|Mean Change From Baseline in FACT-F Score for Participants With a VAS Improvement of 5 ± 3 Points|"The FACT-F subscale consists of 13 fatigue-related items (statements) that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants are asked to indicate how they feel in response to each of the 13 statements on a scale from 0 for Not at all to 4 for Very much. Total scores for the FACT-F subscale can range from 0 to 52; the higher the score the better the quality of life. A positive change (>0) from baseline score constitutes an improvement in fatigue between Baseline and Week 9. The fatigue-visual analog scale (VAS) is a 100-point scale where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue)."|Baseline and Week 9|Primary analysis set participants with a fatigue VAS score improvement at Week 9 of 5 ± 3 points from Baseline|||units on a scale||Standard Deviation|Mean
2675634|NCT01444456|Secondary|Percentage of Participants by Tumor Type With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL|"Improvement in PPF was defined as improvement at week 9 in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference [MID]), and an increase in hemoglobin was defined as ≥ 1 g/dL increase from Baseline. The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for Not at all to 4 for Very much. Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue)."|Baseline to Week 9|Primary analysis set|||percentage of participants||95% Confidence Interval|Number
2675635|NCT01444456|Primary|Percentage of Participants Receiving Darbepoetin Alfa With Improvement in Patient Perceived Fatigue (PPF) and Increase in Hemoglobin ≥ 1 g/dL|"Improvement in PPF was defined as improvement at Week 9 in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) score of ≥ 3.5 points from Baseline (the minimally important difference [MID]), and an increase in hemoglobin was defined as ≥ 1 g/dL increase from Baseline. The FACT-F MID was determined by the mean FACT-F change score (between Baseline and Week 9) for participants who had an improvement in the fatigue visual analog scale (VAS) score of 5 ± 3 points. The FACT-F subscale consists of 13 fatigue-related items that are a subset of the Functional Assessment of Cancer Therapy - Anaemia (FACT-An) questionnaire. Participants indicate how they feel in response to 13 statements on a scale from 0 for Not at all to 4 for Very much. Total scores for the FACT-F subscale range from 0 to 52; the higher the score the better the quality of life. The fatigue-VAS is a 100-point scale, where fatigue-levels are rated from 0 (least fatigue) to 100 (worst possible fatigue)."|Baseline to Week 9 (Treatment Day 57). Due to the observational nature of the study and variation in ESA dosing schedules, assessments closest to day 57 and within Days 43 to 70 (inclusive) were used to calculate the Week 9 visit results.|The Primary analysis set consists of enrolled participants who received at least 1 dose of darbepoetin alfa, have baseline assessments for each of Hemoglobin, FACT-F subscale and VAS, and analyzable post-baseline assessments for each of Hemoglobin, FACT-F subscale, and VAS at Week 9.|||percentage of participants||95% Confidence Interval|Number
2675636|NCT01444430|Secondary|Number of Participants Experiencing Discontinuation of Investigational Product Due to a Protocol Defined Asthma Exacerbation|Number of participants experiencing discontinuation of investigational product due to a protocol defined asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.|Up to 26 weeks|The On treatment Analysis set comprised of all randomized patients and included data that corresponded to each patient’s period of exposure to study drug plus 7 days after the last date of study drug treatment.|||Participants|||Number
2675637|NCT01444430|Secondary|Percent of Nights With Awakening(s) Due to Asthma|Percent of nights with awakening(s) due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.|Daily up to 26 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.|||Percentage of nights||Standard Error|Least Squares Mean
2675639|NCT01444430|Secondary|Mean Number of Puffs of Rescue Medication Per 24 Hours|Mean number of puffs of rescue medication per day (24 hours) during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.|Daily up to 26 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.|||Inhalations/day||Standard Error|Least Squares Mean
2675709|NCT01444378|Secondary|Maximum Walking Distance||1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants|||Number
2675640|NCT01444430|Secondary|Percent of Days With Activity Limitation Due to Asthma|Percent of days with activity limitation due to asthma during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.|Daily up to 26 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug. The analysis set comprises of all patients with at least one day with asthma symptoms, i.e. the denominator is the number of days with asthma symptoms.|||Percentage of days||Standard Error|Least Squares Mean
2675641|NCT01444430|Secondary|Percent of Days With no Asthma Symptoms|Percent of days with no asthma symptoms during the randomized treatment period. Analysis of variance (ANOVA) model including the fixed factors of treatment and strata by incoming control/asthma treatment was used to compare Symbicort and budesonide.|Daily up to 26 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug and had at least one entry of diary data after randomization.|||Percentage of days||Standard Error|Least Squares Mean
2675642|NCT01444430|Primary|Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation|Number of participants experiencing an event included in the definition of asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.|Up to 26 weeks|The On treatment Analysis set comprised of all randomized patients and included data that corresponded to each patient’s period of exposure to study drug plus 7 days after the last date of study drug treatment.|||Participants|||Number
2675643|NCT01444430|Primary|Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization)|Number of participants experiencing an event in the composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization), using events adjudicated and confirmed by the Joint Adjudication Committee. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated.|Up to 27 weeks|Full analysis set (FAS) population comprised of all patients randomized to study drug.|||Participants|||Number
2675644|NCT01444417|Secondary|Number of Participants With Adverse Events|"A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:~fatal,~life threatening (places the subject at immediate risk of death),~requires in-patient hospitalization or prolongation of existing hospitalization,~results in persistent or significant disability/incapacity,~congenital anomaly/birth defect, and/or~other significant medical hazard. Adverse events were graded for severity according to the CTCAE version 3.0 grading scale, where Grade 3 = moderate, Grade 4 = life-threatening and Grade 5 = fatal.~Treatment-related adverse events (TRAEs) were those assessed by the investigator as possibly related to study drug. This relationship was determined by a yes or no response to the question: Is there a reasonable possibility that the event may have been caused by study drug?"|From the first dose of study drug until 4 weeks after last dose; 28 weeks.|Safety analysis set (all participants who received at least one dose of study drug)|||participants|||Number
2675645|NCT01444417|Secondary|Total Number of Composite Bleeding Episodes|A composite bleeding episode was defined as clinically significant bleeding events or the use of a rescue medication to prevent a clinical significant bleeding event during weeks 2 through 25 of the treatment period. A clinically significant bleeding event was defined as a Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grade ≥ 2 bleeding event.|Week 2 to week 25|Efficacy analysis set|||bleeding episodes||Standard Deviation|Mean
2675646|NCT01444417|Secondary|Percentage of Participants Who Received Rescue Medication During the Treatment Period|Rescue medication is any medication (other than excluded medications) that is intended to increase platelet counts or prevent bleeding.|24 weeks|Efficacy analysis set|||percentage of participants||95% Confidence Interval|Number
2675647|NCT01444417|Secondary|Number of Weeks With Platelet Response|Number of weeks with platelet counts ≥ 50 x 10^9/L during week 2 to week 25 measurements. Participants may not have had a weekly response within 4 weeks after receiving any rescue medications.|Week 2 to week 25|Efficacy analysis set|||weeks||Full Range|Median
2675648|NCT01444417|Secondary|Percentage of Participants With an Overall Platelet Response|"Overall platelet response is defined as either a durable platelet response or transient platelet response.~Durable platelet response was defined as weekly platelet count ≥ 50 x 10^9/L for 6 or more times during week 18 to week 25 measurements. Participants may not have had a weekly response within 4 weeks after receiving any rescue medication.~Transient platelet response was defined as weekly platelet count ≥ 50 x 10^9/L for 4 or more times during week 2 to week 25 measurements but without durable platelet response. Participants may not have had a weekly response within 4 weeks after receiving any rescue medications."|Week 2 to week 25|Efficacy analysis set|||percentage of participants||95% Confidence Interval|Number
2675649|NCT01444417|Primary|Percentage of Participants With a Durable Platelet Response|A participant with durable platelet response was defined as achieving at least 6 weekly platelet counts of ≥ 50 x 10^9/L during the last 8 weeks of treatment (platelet counts obtained from week 18 to week 25). If a platelet count from a participant was not available (missing) in a certain week, that week was imputed as non-response for that participant. Platelet counts were not deemed as a positive response for 4 weeks after the administration of rescue medication.|Week 18 to week 25|Efficacy analysis set (all randomized participants)|||percentage of participants||95% Confidence Interval|Number
2675650|NCT01444391|Secondary|Tube Retention|Tube retention is the presence of a tympanostomy tube placed successfully by the Tula TDS device across the tympanic membrane at the two-week follow-up visit.|2 weeks post-procedure|"This outcome measure analysis includes evaluation only of ears with TDS-placed tube.~Two subjects (3 ears) were excluded due to missing follow-up data. An additional 3 subjects (4 ears) were excluded because no TDS tube was placed. Three of the 37 participants analyzed had one of two study ears excluded, due to no TDS in that ear."|||ears|Participants||Number
2675710|NCT01444378|Secondary|Maximum Walking Distance||Pre-procedure|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants|||Number
2675651|NCT01444391|Secondary|Procedure Tolerability|Procedure Tolerability is defined as the proportion of subjects reporting the procedure as tolerable, where tolerable is defined as a score of 0 through 3, using the Wong-Baker FACES pain scale.The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Procedure Tolerability will be determined on a per patient basis, with the patient's score being the average of the scores for the left and right ear if both ears are successfully treated with the Tube Delivery System.|Day 0 (day of procedure)|The analysis population includes subjects with successful tube placement using the Tube Delivery System (TDS) in one or both ears. Six subjects were excluded for whom one ear had a successful TDS placement and one ear did not.|||participants|||Number
2675652|NCT01444391|Secondary|Procedure Success|Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis.|Day 0 (day of procedure)||||participants|||Number
2675653|NCT01444391|Primary|Device Success|Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis.|Day 0 (day of procedure)||||devices|Participants||Number
2675654|NCT01444391|Primary|Number of Subjects With Procedural, Serious and Device-related Adverse Events.|Adverse events which are procedural, serious, and device-related.|Procedure through 2 weeks post-procedure||||subjects|||Number
2675655|NCT01444378|Secondary|Vascular Quality of Life (VascuQol) Total Scores|Vascular Quality of Life (VascuQol) : A standardized, validated questionnaire used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 7 point response scale, with a score of 1 being the worst and a score of 7 the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. There are no sub scales.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675656|NCT01444378|Secondary|Vascular Quality of Life (VascuQol) Total Scores|Vascular Quality of Life (VascuQol) : A standardized, validated questionnaire used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 7 point response scale, with a score of 1 being the worst and a score of 7 the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome. There are no sub scales.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675657|NCT01444378|Secondary|Vascular Quality of Life (VascuQol) Total Scores|"Vascular Quality of Life (VascuQol) : A standardized, validated questionnaire used to evaluate vascular disease-specific health outcomes. VascuQol total score includes scores of Activity Domain, Symptom Domain, Pain Domain, Emotional Domain and Social Domain. Each item is rated as a 7 point response scale, with a score of 1 being the worst and a score of 7 the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.~There are no sub scales."|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675658|NCT01444378|Secondary|Quality of Life Measures : Mental Component Summary (MCS)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675659|NCT01444378|Secondary|Quality of Life Measures : Mental Component Summary (MCS)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675660|NCT01444378|Secondary|Quality of Life Measures : Mental Component Summary (MCS)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675661|NCT01444378|Secondary|Quality of Life Measures : Physical Component Summary (PCS)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675662|NCT01444378|Secondary|Quality of Life Measures : Physical Component Summary (PCS)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675664|NCT01444378|Secondary|Quality of Life Measures : Mental Health (MH)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675665|NCT01444378|Secondary|Quality of Life Measures : Mental Health (MH)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675666|NCT01444378|Secondary|Quality of Life Measures : Mental Health (MH)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675667|NCT01444378|Secondary|Quality of Life Measures : Role Emotional (RE)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675668|NCT01444378|Secondary|Quality of Life Measures : Role Emotional (RE)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675669|NCT01444378|Secondary|Quality of Life Measures : Role Emotional (RE)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675670|NCT01444378|Secondary|Quality of Life Measures : Social Functioning (SF)|"SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.~rm-Based Scores."|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675671|NCT01444378|Secondary|Quality of Life Measures : Social Functioning (SF)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675672|NCT01444378|Secondary|Quality of Life Measures : Social Functioning (SF)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675673|NCT01444378|Secondary|Quality of Life Measures : Vitality (VT)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675674|NCT01444378|Secondary|Quality of Life Measures : Vitality (VT)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675675|NCT01444378|Secondary|Quality of Life Measures : Vitality (VT)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675676|NCT01444378|Secondary|Quality of Life Measures : General Health (GH)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675705|NCT01444378|Secondary|Toe Brachial Index (TBI)|The toe brachial index is the ratio of the resting ipsilateral toe systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|At 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||ratio||Standard Deviation|Mean
2675677|NCT01444378|Secondary|Quality of Life Measures : General Health (GH)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675678|NCT01444378|Secondary|Quality of Life Measures : General Health (GH)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675679|NCT01444378|Secondary|Quality of Life Measures : Bodily Pain (BP)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675680|NCT01444378|Secondary|Quality of Life Measures : Bodily Pain (BP)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675681|NCT01444378|Secondary|Quality of Life Measures : Bodily Pain (BP)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675682|NCT01444378|Secondary|Quality of Life Measures : Role Physical (RP)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675683|NCT01444378|Secondary|Quality of Life Measures : Role Physical (RP)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675684|NCT01444378|Secondary|Quality of Life Measures : Role Physical (RP)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675685|NCT01444378|Secondary|Quality of Life Measures : Physical Functioning (PF)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675686|NCT01444378|Secondary|Quality of Life Measures : Physical Functioning (PF)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675687|NCT01444378|Secondary|Quality of Life Measures : Physical Functioning (PF)|SF-12 Norm-Based Scores; Quality of Life (SF-12®) is a standardized, validated questionnaire used to evaluate general health outcomes. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2675688|NCT01444378|Secondary|Freedom From Ipsilateral Major Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 379 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2675689|NCT01444378|Secondary|Freedom From Ipsilateral Major Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 365 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2675690|NCT01444378|Secondary|Freedom From Ipsilateral Major Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 180 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2675691|NCT01444378|Secondary|Freedom From Ipsilateral Major Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 30 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2675692|NCT01444378|Secondary|Freedom From Ipsilateral Major Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|At day 0 (on the day of index procedure)|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2675693|NCT01444378|Secondary|In-Stent Percent Diameter Stenosis (%DS)|"Percent Diameter Stenosis:~The value calculated as 100 * (1 - Minimum Lumen Diameter/Reference Vessel Diameter) using the mean values from two orthogonal views (when possible) by Quantitative Analysis."|Post-Procedure (≥ 1 day)|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percent Diameter stenosis||Standard Deviation|Mean
2675694|NCT01444378|Secondary|In-Segment Percent Diameter Stenosis (%DS)|"Percent Diameter Stenosis:~The value calculated as 100 * (1 - Minimum Lumen Diameter/Reference Vessel Diameter) using the mean values from two orthogonal views (when possible) by Quantitative Analysis."|Post-Procedure (≥ 1 day)|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percent Diameter stenosis|Target lesions|Standard Deviation|Mean
2675695|NCT01444378|Secondary|In-Segment Percent Diameter Stenosis (%DS)|"Percent Diameter Stenosis:~The value calculated as 100 * (1 - Minimum Lumen Diameter/Reference Vessel Diameter) using the mean values from two orthogonal views (when possible) by Quantitative Analysis."|Pre-Procedure|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Percent Diameter stenosis|Target lesions|Standard Deviation|Mean
2675696|NCT01444378|Secondary|Stent Occlusion|Stent occlusion was defined as total occlusion identified within the stent by arteriography and/or ultrasound that occurs > 30 days post-index procedure.|> 30 Days Post Study Procedure|ITT population.|||percentage of participants|||Number
2675697|NCT01444378|Secondary|Sub-Acute Stent Thrombosis|Stent thrombosis was defined as total occlusion identified within the stent by arteriography and/or ultrasound that occurs within 30 days post-index procedure.|> 24 Hours - 30 Days Post Study Procedure|ITT population.|||percentage of participants|||Number
2675698|NCT01444378|Secondary|Acute Stent Thrombosis|Stent thrombosis was defined as total occlusion identified within the stent by arteriography and/or ultrasound that occurs within 30 days post-index procedure.|0 - 24 Hours Post Study Procedure|ITT population.|||percentage of participants|||Number
2675699|NCT01444378|Secondary|Duplex Ultrasound: In-Stent Peak Systolic Velocity Ratio (PSVR)|In-Stent Restenosis: Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography. A PSVR of > 2.4 will be used to determine restenosis via duplex ultrasound.|12 months|ITT population, per lesion analysis. In-stent peak systolic velocity (PSV) and in-stent peak systolic velocity ratio (PSVR) are excluded from the analysis, for subjects who had TLR prior to the duplex ultrasound or duplex ultrasound was out of the protocol defined window or duplex ultrasound was not readable.|||cm/sec|Target lesions|Standard Deviation|Mean
2675700|NCT01444378|Secondary|Duplex Ultrasound: In-Stent Peak Systolic Velocity Ratio (PSVR)|In-Stent Restenosis: Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography. A PSVR of > 2.4 will be used to determine restenosis via duplex ultrasound.|1 month|ITT population, per lesion analysis. In-stent peak systolic velocity (PSV) and in-stent peak systolic velocity ratio (PSVR) are excluded from the analysis, for subjects who had TLR prior to the duplex ultrasound or duplex ultrasound was out of the protocol defined window or duplex ultrasound was not readable.|||cm/sec|Target lesions|Standard Deviation|Mean
2675701|NCT01444378|Secondary|Duplex Ultrasound: Maximum In-Stent Peak Systolic Velocity (PSV)|"In-Stent Restenosis:~Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography."|12 months|ITT population, per lesion analysis. In-stent peak systolic velocity (PSV) and in-stent peak systolic velocity ratio (PSVR) are excluded from the analysis, for subjects who had TLR prior to the duplex ultrasound or duplex ultrasound was out of the protocol defined window or duplex ultrasound was not readable.|||cm/sec|Target lesions|Standard Deviation|Mean
2675702|NCT01444378|Secondary|Duplex Ultrasound: Maximum In-Stent Peak Systolic Velocity (PSV)|"In-Stent Restenosis:~Re-narrowing within the margins of the stent following the reduction of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by duplex ultrasound or arteriography."|1 month|ITT population, per lesion analysis. In-stent peak systolic velocity (PSV) and in-stent peak systolic velocity ratio (PSVR) are excluded from the analysis, for subjects who had TLR prior to the duplex ultrasound or duplex ultrasound was out of the protocol defined window or duplex ultrasound was not readable.|||cm/sec|Target lesions|Standard Deviation|Mean
2675703|NCT01444378|Secondary|Toe Brachial Index (TBI)|The toe brachial index is the ratio of the resting ipsilateral toe systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|At 1 year|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||ratio||Standard Deviation|Mean
2675704|NCT01444378|Secondary|Toe Brachial Index (TBI)|The toe brachial index is the ratio of the resting ipsilateral toe systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|At 6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||ratio||Standard Deviation|Mean
2675762|NCT01444092|Secondary|PCDAI|Paediatric Crohn's Disease Activity Index. Range from 0 (best) to 100 (worst).|Baseline to 8 weeks|Full analysis set|||Units on a scale||Standard Deviation|Mean
2675711|NCT01444378|Secondary|Walking Impairment Questionnaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|12 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
2675712|NCT01444378|Secondary|Walking Impairment Questionnaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
2675713|NCT01444378|Secondary|Walking Impairment Questionnaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
2675714|NCT01444378|Secondary|Walking Impairment Questionnaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|Pre-procedure|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||scores on a scale||Standard Deviation|Mean
2675715|NCT01444378|Secondary|Rutherford-Becker Clinical Category for the Treated Limb|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable."|12 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants|||Number
2675716|NCT01444378|Secondary|Rutherford-Becker Clinical Category for the Treated Limb|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable."|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants|||Number
2675717|NCT01444378|Secondary|Rutherford-Becker Clinical Category for the Treated Limb|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable."|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants|||Number
2675718|NCT01444378|Secondary|Rutherford-Becker Clinical Category for the Treated Limb|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable."|Pre-procedure|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants|||Number
2675719|NCT01444378|Secondary|Embolic Events in the Treated Limb (as Reported by Site)|Embolic Event is defined as formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|At 1 year|ITT population, per subject analysis.|||percentage of participants|||Number
2675720|NCT01444378|Secondary|Embolic Events in the Treated Limb (as Reported by Site)|Embolic Event is defined as formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|At 6 months|ITT population, per subject analysis.|||percentage of participants|||Number
2675763|NCT01444092|Primary|Adverse Event|Number of patients with at least one adverse event|12 weeks|Safety analysis set|||Patients|||Number
2675721|NCT01444378|Secondary|Embolic Events in the Treated Limb (as Reported by Site)|Embolic Event is defined as formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|At 1 month|ITT population, per subject analysis.|||percentage of participants|||Number
2675722|NCT01444378|Secondary|Freedom From Any Ipsilateral Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 379 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2675723|NCT01444378|Secondary|Freedom From Any Ipsilateral Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 365 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2675724|NCT01444378|Secondary|Freedom From Any Ipsilateral Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 180 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2675725|NCT01444378|Secondary|Freedom From Any Ipsilateral Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|0 to 30 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2675726|NCT01444378|Secondary|Freedom From Any Ipsilateral Amputation|Amputation is defined as the removal of a body extremity by surgery. For this trial, the definition of amputation will only include amputations of the limb that was treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.|At day 0 (on the day of index procedure)|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2675727|NCT01444378|Secondary|Freedom From Stent Patency|Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.|0 to 379 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2675728|NCT01444378|Secondary|Freedom From Stent Patency|Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.|0 to 365 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2675729|NCT01444378|Secondary|Freedom From Stent Patency|Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.|0 to 180 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2675730|NCT01444378|Secondary|Freedom From Stent Patency|Primary Stent Patency defined as < 50% stenosis of the stented segment, as determined by duplex ultrasound or arteriography.|0 to 30 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2675731|NCT01444378|Secondary|Death||At 1 year|ITT population, per subject analysis.|||percentage of participants|||Number
2675732|NCT01444378|Secondary|Death||At 6 months|ITT population, per subject analysis.|||percentage of participants|||Number
2675733|NCT01444378|Secondary|Death||At 1 month|ITT population, per subject analysis.|||percentage of participants|||Number
2675734|NCT01444378|Secondary|Target Vessel Revascularization (TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the ipsilateral superficial femoral artery and the proximal popliteal artery, including the target lesion itself.|At 1 year|ITT population, per subject analysis.|||percentage of participants|||Number
2675735|NCT01444378|Secondary|Target Vessel Revascularization (TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the ipsilateral superficial femoral artery and the proximal popliteal artery, including the target lesion itself.|At 6 months|ITT population, per subject analysis.|||percentage of participants|||Number
2675736|NCT01444378|Secondary|Target Vessel Revascularization (TVR)|TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the ipsilateral superficial femoral artery and the proximal popliteal artery, including the target lesion itself.|At 1 month|ITT population, per subject analysis.|||percentage of participants|||Number
2675737|NCT01444378|Secondary|Any Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be prospectively classified as clinically-driven or not clinically-driven by the investigator prior to repeat angiography. An independent angiographic core laboratory will verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.|At 1 year|ITT population, per subject analysis.|||percentage of participants|||Number
2675738|NCT01444378|Secondary|Any Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be prospectively classified as clinically-driven or not clinically-driven by the investigator prior to repeat angiography. An independent angiographic core laboratory will verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.|At 6 months|ITT population, per subject analysis.|||percentage of participants|||Number
2675739|NCT01444378|Secondary|Any Target Lesion Revascularization (TLR)|TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be prospectively classified as clinically-driven or not clinically-driven by the investigator prior to repeat angiography. An independent angiographic core laboratory will verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.|At 1 month|ITT population, per subject analysis.|||percentage of participants|||Number
2675740|NCT01444378|Secondary|Clinically-driven Target Lesion Revascularization (CD-TLR)|"Revascularization within the borders of the stent, +5 mm unstented vessel at both ends, with diameter stenosis ≥ 50% (determined by duplex ultrasound or angiographic core laboratory) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel) plus one or both of the following:~Worsening Rutherford-Becker Clinical Category;~Change in ABI by >0.15 and ABI ≤0.8"|At 1 year|ITT population, per subject analysis.|||percentage of participants|||Number
2675741|NCT01444378|Secondary|Clinically-driven Target Lesion Revascularization (CD-TLR)|"Revascularization within the borders of the stent, +5 mm unstented vessel at both ends, with diameter stenosis ≥ 50% (determined by duplex ultrasound or angiographic core laboratory) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel) plus one or both of the following:~Worsening Rutherford-Becker Clinical Category;~Change in ABI by >0.15 and ABI ≤0.8"|At 6 months|ITT population, per subject analysis.|||percentage of participants|||Number
2675742|NCT01444378|Secondary|Clinically-driven Target Lesion Revascularization (CD-TLR)|"Revascularization within the borders of the stent, +5 mm unstented vessel at both ends, with diameter stenosis ≥ 50% (determined by duplex ultrasound or angiographic core laboratory) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel) plus one or both of the following:~Worsening Rutherford-Becker Clinical Category;~Change in ABI by >0.15 and ABI ≤0.8"|At 1 month|ITT population, per subject analysis.|||percentage of participants|||Number
2675743|NCT01444378|Secondary|Ankle Brachial Index (ABI) for the Treated Limb|"A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.~ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.~A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used."|12 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point. ABI > 1.3 was excluded from the analysis.|||Ratio||Standard Deviation|Mean
2675744|NCT01444378|Secondary|Ankle Brachial Index (ABI) for the Treated Limb|"A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.~ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.~A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used."|6 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point. ABI > 1.3 was excluded from the analysis.|||Ratio||Standard Deviation|Mean
2675745|NCT01444378|Secondary|Ankle Brachial Index (ABI) for the Treated Limb|"A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.~ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.~A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used."|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point. ABI > 1.3 was excluded from the analysis.|||Ratio||Standard Deviation|Mean
2675764|NCT01444027|Primary|Caregiver Quality of Life - Financial: Change From Baseline to Post-Intervention Exit|An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better financial quality of life.|At Baseline and Exit (approximately 4 weeks after recruitment)|Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data.|||units on a scale||Standard Error|Mean
2675779|NCT01443845|Secondary|Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1)|Mean change from randomization (Visit 2) over 52 weeks of treatment in predose forced expiratory volume in 1 second (FEV1)|Week 0 (Visit 2) to Week 52|Intent-to-Treat Population who the completed 52-week treatment period|||Liters||Standard Error|Least Squares Mean
2675746|NCT01444378|Secondary|Ankle Brachial Index (ABI) for the Treated Limb|"A measure of the fall in blood pressure in the arteries supplying the legs and is used to detect evidence of blockages in the peripheral vessels. It is calculated by dividing the higher systolic blood pressure in the ankle (dorsalis pedis or posterior tibial) of the one leg by the higher of the two systolic blood pressures in the arms.~ABI=Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure. The ABI is the ratio of the ankle to arm pressure, and an ABI between 0.9 and 1.3 is considered normal. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 severe disease.~A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. For patients in whom the ABI cannot be accurately measured , toe pressure measurement and toe brachial index should be used."|Pre-Procedure|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point. ABI > 1.3 was excluded from the analysis.|||Ratio||Standard Deviation|Mean
2675747|NCT01444378|Secondary|Freedom From Vessel Patency|This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.|0 to 180 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2675748|NCT01444378|Secondary|Freedom From Vessel Patency|This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.|0 to 30 days|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2675749|NCT01444378|Secondary|Acute Success : Technical Success|Technical success: Device success plus attainment of final residual stenosis of < 30%|With in 2 days of index post procedure|ITT population, per lesion analysis|||percentage of target lesions|Target Lesions||Number
2675750|NCT01444378|Secondary|Acute Success : Clinical Success|Clinical success: Defined on a per patient basis, as the attainment of a final residual stenosis of < 30% by core laboratory assessment using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications within 2 days after the index procedure or at hospital discharge, whichever is sooner.|With in 2 days after index post procedure or at hospital discharge (before 1 month)|ITT population, per subject analysis|||percentage of participants|||Number
2675751|NCT01444378|Secondary|Acute Success : Device Success|Device success defined on a per device basis, as the achievement of successful delivery and deployment of the trial device at the intended target lesion and successful withdrawal of the delivery catheter.|With in 2 days of index post procedure|ITT population, per device analysis.|||percentage of devices|Device||Number
2675752|NCT01444378|Primary|Freedom From Vessel Patency|This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.|0 to 365 days|Intention-to-treat (ITT) population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2675753|NCT01444378|Primary|Major Adverse Event (MAE)|"Primary safety endpoint is freedom from MAE which is defined as a composite of:~Death due to all causes~Index limb major amputation (at or above the ankle)~Clinically-driven target lesion revascularization (TLR)"|30 days||||percentage of participants|||Number
2675754|NCT01444300|Secondary|Change in Timed 25 Foot Walking Speed||Baseline to 12 weeks||||seconds||Standard Deviation|Mean
2675755|NCT01444300|Secondary|Change in Activities-specific Balance Confidence (ABC) Questionnaire Scores|The ABC is an 11-point scale and subjects are asked to indicate personal level of confidence in doing specific activities without losing balance or becoming unsteady on a scale from 0% to 100%. The ratings are added (possible range =0 -1600) and divide by 16 to get each subject's ABC score. A high ABC score indicates a high degree of confidence and a low ABC score indicates a low degree of confidence.|Baseline to 12 weeks||||Scores on a scale||Standard Deviation|Mean
2675756|NCT01444300|Primary|Change in Automatic Postural Response (APR )Latency|Automatic Postural Response (APR) latencies will be measured by Computerized Dynamic Posturography (CDP). The restoration of balance after an unexpected movement by Computerized Dynamic Posturography relies on automated postural responses in the upper and lower legs, trunk, shoulders, and neck muscles. APR latency is the reaction- time response to movements of the support surface on which the subject stands. These responses typically occur at onset latencies of ~100 milliseconds. In response to a change, both feet-in-place and stepping strategies can be used to recover balance, with the incidence of stepping responses becoming larger as the change magnitude increases voluntary movements in human subjects.|Baseline to 12 weeks||||milliseconds||Standard Deviation|Mean
2675757|NCT01444287|Secondary|Overall Comfort|Patient reported subjective comfort of lenses or spectacles (range 0-100, where 100 is best).|after 8 hours||||units on a scale||Standard Error|Least Squares Mean
2675758|NCT01444287|Primary|Limbal Redness|Scale of 0 to 4, where 0=none and 4= severe redness. Measure reported as a comparison of 8 hours of wear to baseline with the difference being reported.|Baseline, After 8 hours of treatment conditions||||units on a scale||Standard Error|Least Squares Mean
2675759|NCT01444287|Primary|Endothelial Blebs|Corneal images captured with equipment are measured, manually outlined to estimate total bleb area from 0 to 100%. This is measured as a change in percentage after 20 minutes compared to the value prior to lens wear (baseline).|baseline, after 20 minutes of treatment conditions||||percentage of bleb area||Standard Error|Mean
2675760|NCT01444287|Primary|Corneal Thickness|Percentage of corneal swelling (positive value) or deswelling (negative value) measured with Haag-Streit pachymetry equipment in microns, reported as a percent.|After 8 hours of contact lens wear|Subjects are those enrolled and randomized to a trial arm.|||Percent Change||Standard Error|Least Squares Mean
2675761|NCT01444092|Secondary|IMPACT 3|IMPACT 3 is a self-administered QoL form. The score ranges from 35 (poor) to 175 (best).|Baseline to 8 weeks|Safety analysis set|||Units on a scale||Standard Deviation|Mean
2675765|NCT01444027|Primary|Caregiver Quality of Life - Emotional: Change From Baseline to Post-Intervention Exit|An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better emotional quality of life.|At Baseline and Exit (approximately 4 weeks after recruitment)|Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data.|||units on a scale||Standard Error|Mean
2675766|NCT01444027|Primary|Caregiver Quality of Life - Social: Change From Baseline to Post-Intervention Exit|An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better social quality of life.|At Baseline and Exit (approximately 4 weeks after recruitment)|Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data.|||units on a scale||Standard Error|Mean
2675767|NCT01444027|Primary|Caregiver Quality of Life - Physical: Change From Baseline to Post-Intervention Exit|An interview CQLI version was developed by using identical items from the paper-based CQLI and replacing the visual analogue response format with a 0-10 response scale. Higher scores indicate better physical quality of life.|At Baseline and Exit (approximately 4 weeks after recruitment)|Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data.|||units on a scale||Standard Error|Mean
2675768|NCT01444027|Primary|Caregiver Anxiety: Change From Baseline to Post-Intervention Exit|Caregiver anxiety was measured with the 7-item Generalized Anxiety Disorder (GAD-7) Scale (Spitzer et al., 2006), which measures the frequency with which respondents experience symptoms of anxiety such as restlessness, difficulty relaxing, and uncontrollable worrying. The GAD-7 total scores range from 0 to 21, with higher scores indicating more anxiety.|At Baseline and Exit (approximately 4 weeks after recruitment)|Intent to treat population (all participants who received at least one intervention session). Multiple imputation was used to replace missing data.|||units on a scale||Standard Error|Mean
2675769|NCT01443923|Secondary|Efficacy (SVR) Rates as Predicted by Viral Response at the End of the 4-week lead-in Therapy With PEG/RBV and Comparison Between HCV Monoinfected and HIV/HCV Coinfected Subjects||6 months post treatment|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.||||||
2675770|NCT01443923|Secondary|Proportion of Subjects Who Are Receiving HAART Who Remain With an HIV RNA & lt; 400 Copies/mL and Those With HIV RNA & gt; 400 Copies/mL at End of Treatment||End of Treatment|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.||||||
2675771|NCT01443923|Secondary|Safety and Treatment Outcome Measures Stratified by ESA Use||6 months|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.||||||
2675772|NCT01443923|Secondary|Change in Early HCV Viral Load Kinetics Between Mono and Co-infected Subjects||Day 0, Day 7|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.||||||
2675773|NCT01443923|Primary|Efficacy, Defined as Sustained Viral Response (SVR) Six Months After the End of Specified Treatment.||6 months post treatment|Due to the change in the standard of care treatment of HCV, it became difficult to recruit patients to receive IFN based therapy with the prospects of IFN free treatment being available sooner. Study was prematurely terminated and no data was collected/analyzed for the Outcome.||||||
2675774|NCT01443858|Secondary|Percentage of Change of CO at End of Week 3 When Comparing Abstinent Smokers Versus Non-abstinent Smokers|To further validate the association between a decrease in expired air CO before the quit date and subsequent abstinence, the decrease in expired air CO from baseline to week 3 (Session P3) will be compared between abstinent and non-abstinent smokers, using ANOVA.|After 3 weeks of treatment (relative to baseline)|"Abstinent (n=2 Control, 7 25mg, 2 50mg) Non-abstinent (n=16 Control, 16 25mg, 23 50mg)"|||percentage change||Standard Error|Mean
2675775|NCT01443858|Secondary|Percentage of Change of CO at End of Week 1 When Comparing Abstinent Smokers Versus Non-abstinent Smokers|To further validate the association between a decrease in expired air CO before the quit date and subsequent abstinence, the decrease in expired air CO from baseline to week 1 (Session P2) will be compared between abstinent and non-abstinent smokers, using ANOVA.|After 1 week of treatment (relative to baseline)|"Abstinent (n=2 Control, 7 25mg, 2 50mg) Non-abstinent (n=16 Control, 16 25mg, 23 50mg)"|||percentage change||Standard Error|Mean
2675776|NCT01443858|Secondary|Number of Participants Completing the Continuous 4 Week Abstinence From Smoking|Continuous 4 week abstinence from smoking (weeks 3-6 post quit date), based on self-reported abstinence confirmed by expired air CO ≤8ppm, will be compared between each meclizine group and placebo, using logistic regression analyses|weeks 3-6 post quit date||||participants||95% Confidence Interval|Number
2675777|NCT01443858|Primary|Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 3|To evaluate the effects of meclizine as an augmentation treatment in conjunction with nicotine patch, the percent decrease in expired air carbon monoxide (CO) at the end of week 3 (relative to baseline) will be compared (using ANOVA) between each meclizine group and placebo.|After 3 weeks of treatment (relative to baseline)||||percentage change||Standard Error|Mean
2675778|NCT01443858|Primary|Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 1|To evaluate the effects of meclizine alone on ad lib smoking, the percent decrease in expired air carbon monoxide (CO) at the end of week 1 (relative to baseline) will be compared (using ANOVA) between each meclizine group and placebo.|After 1 week of treatment (relative to baseline)||||percentage change||Standard Error|Mean
2675780|NCT01443845|Secondary|Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics|Rate of moderate or severe COPD exacerbations treated with antibiotics during the double-blind treatment period.|Week 0 (Visit 2) to Week 52||||COPD Exacerbations per Patient per Year||95% Confidence Interval|Number
2675781|NCT01443845|Secondary|Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations)|Rate of moderate or severe COPD exacerbations, defined as requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.|Week 0 (Visit 2) to Week 52|Intent-to-Treat Study Population|||COPD exacerbations per patient per year||95% Confidence Interval|Number
2675782|NCT01443845|Primary|Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year.|Rate of moderate or severe COPD exacerbations, defined as requiring oral or parenteral glucocorticosteroids (moderate) or requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.|Baseline to Week 52|Intent-to-Treat Study Population|||COPD exacerbations per patient per year||95% Confidence Interval|Number
2675783|NCT01443546|Secondary|Pregnancies Per Transfer|Pregnancy rate per transfer will be assessed by hCG level on day 14 post retrieval and clinical pregnancy rate will be assessed by ultrasound on day 28 post retrieval. This will additionally assess efficacy of intervention.|4 weeks post retrieval|Data was not completed by study participants so data was not analyzed for comparison||||||
2675784|NCT01443546|Secondary|Number of Mature Oocytes Retrieved|Number of mature oocytes retrieved will assess the efficacy of the intervention|1 day post ovulation|Data was not completed by study participants so data was not analyzed for comparison||||||
2675785|NCT01443546|Primary|Ovarian Volume|Ovarian volume of both ovaries will be measured by ultrasound on post op day number 7. Measurements will be taken in three different dimensions and volume calculated from those measurements.|7 days post retrieval|data for ovarian volume was not collected by 3D ultrasound||||||
2675786|NCT01443546|Primary|Number of Days Post Retrieval Until Subject is Able to Resume Her Usual Activities|Subjects will complete a brief questionnaire on post retrieval day 7. They will state how many days after retrieval they were able to resume their usual activities.|7 days post retrieval|Data was not completed by study participants so data was not analyzed for comparison||||||
2675787|NCT01443546|Primary|Number of Subjects Having Adverse Events|Any donor having a serious complication such as severe hyperstimulation syndrome, ovarian torsion, infection or peritoneal bleeding will be recorded|1 month|Total of 26 participants were enrolled. Number of subjects enrolled in each arm were below targeted numbers|||participants|||Number
2675788|NCT01443494|Secondary|Perfused Vessel Density|Increasing MAP from 65 mm Hg to target level. The sublingual microcirculation was measured by sidestream dark field, including the parameters of perfused vessel density|Target MAP stabilization for 30 min||||vessels/mm^2||Standard Deviation|Mean
2675789|NCT01443494|Primary|Mean Arterial Pressure|"As chronic hypertensive patients were supposed to have undergone more blood pressure measurements in daily life than non-hypertensive ones, the averaged MAP acquired from patients' physical examination records of the last two years was registered and assumed as patients' usual level of MAP and target MAP. If patients' medical records were incomplete, a detailed enquiry about the target MAP to their next kin was performed.~After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements."|Target MAP stabilization for 30 min||||mmHg||Standard Deviation|Mean
2675790|NCT01443442|Primary|Change From Baseline in Ocular Itching at 14 Days|Ocular Itching Scale. Scale is 0 - 4 in 0.5 scale unit increments. 0 equals no Itch. 4 equals most severe itch. No calculation details are necessary as the change is calculated as the latest time point minus the earliest time point.|Change from Baseline in Ocular Itching at 14 Days||||units on a scale||Standard Deviation|Mean
2675791|NCT01443403|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs)|"Treatment-emergent adverse events (TEAEs) were adverse events that occurred after the first dose of study drug.~Treatment-related TEAEs were defined as TEAEs that were considered by the Investigator to be definitely, probably, or possibly related to study drug."|From first dose of study drug through 28 days after the last dose of study treatment (up to 57 days).|Adverse events were assessed using the safety population. The safety population included all participants who received study drug. This population was analyzed as treated.|||participants|||Number
2675792|NCT01443403|Secondary|Area Under the Concentration-time Curve From Hour 0 to the Time Point of the Last Measurable Concentration Within the Dose Interval (AUC0-τ)|Pharmacokinetic blood samples for naldemedine (S-297995) and its metabolite, Nor-S-297995, were collected from a subset of participants at selected study sites on Day 1 and in a further subset on Day 28.|Day 1 and Day 28 predose and 1, 2 , 4, 8, and 24 hours postdose|PK population with available data|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2675793|NCT01443403|Secondary|Time to Maximum Concentration (Tmax) of Naldemedine and Metabolite Nor-S-297995|Pharmacokinetic blood samples for naldemedine (S-297995) and its metabolite, Nor-S-297995, were collected from a subset of participants at selected study sites on Day 1 and in a further subset on Day 28.|Day 1 and Day 28 predose and 1, 2 , 4, 8, and 24 hours postdose|PK population with available data|||hours||Full Range|Median
2675794|NCT01443403|Secondary|Maximum Observed Plasma Concentration (Cmax) of Naldemedine and Metabolite Nor-S-297995|Pharmacokinetic blood samples for naldemedine (S-297995) and its metabolite, Nor-S-297995, were collected from a subset of participants at selected study sites on Day 1 and in a further subset on Day 28.|Day 1 and Day 28 predose and 1, 2, 4, 8, and 24 hours postdose|The PK parameter population (PK population) includes all participants who received study drug with at least one PK parameter estimated adequately on Day 1 or Day 28|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2675795|NCT01443403|Secondary|Subject Global Satisfaction at End of Treatment|On day 29 (or at early termination), participants were asked about their degree of satisfaction with constipation and abdominal symptoms from the start of study drug dosing to Day 28 (or early termination visit). The grades were as follows: 1, markedly worsened; 2, moderately worsened; 3, slightly worsened; 4, unchanged; 5, slightly improved; 6, moderately improved; and 7, markedly improved.|Day 29, or at early termination|mITT population|||participants|||Number
2675796|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in Abdominal Discomfort|Participants were asked to rate their abdominal discomfort for the past 24 hours on a scale from 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.|Baseline and Weeks 1, 2, 3, and 4|mITT population with a value at both baseline and the specified time point.|||units on a scale||Standard Deviation|Mean
2675797|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Abdominal Discomfort|Participants were asked to rate their abdominal discomfort for the past 24 hours on a scale from 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population with a value at both baseline and the last 2 weeks of treatment.|||units on a scale||Standard Deviation|Mean
2675798|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in Abdominal Bloating|Participants were asked to rate their abdominal bloating for the past 24 hours on a scale of 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.|Baseline and Weeks 1, 2, 3, and 4|mITT population with a value at both baseline and the specified time point.|||units on a scale||Standard Deviation|Mean
2675799|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Abdominal Bloating|Participants were asked to rate their abdominal bloating for the past 24 hours on a scale of 0 to 4, where 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4 = Very Severe.|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population with a value at both baseline and the last 2 weeks of treatment.|||units on a scale||Standard Deviation|Mean
2675800|NCT01443403|Secondary|Mean Rescue Laxative Use Per Week During the Treatment Period|Participants were asked how many doses of rescue laxative medication they had taken within the past 24 hours as part of the Bowel Movement and Constipation Assessment Diary (BMCA).|Weeks 1 to 4|mITT population|||doses/week||Standard Deviation|Mean
2675801|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Rescue Use of Laxative Agents Per Week|Participants were asked how many doses of rescue laxative medication they had taken within the past 24 hours as part of the Bowel Movement and Constipation Assessment Diary (BMCA).|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||doses/week||Standard Deviation|Mean
2675802|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of False Start BMs Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A false start was defined as any attempted, but unsuccessful bowel movement (no solid or liquid fecal material was excreted)."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population with values at both baseline and the last 2 weeks of the treatment period|||false start BMs||Standard Deviation|Mean
2675803|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of SBMs Per Week Without Straining|Straining during BMs was graded using the following scale: 0 = No straining; 1 = Mild straining; 2 = Moderate; 3 = Severe; 4 = Very Severe. A BM without straining is defined as a BM with a straining score of 0 or 1.|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.|||bowel movements/week||Standard Error|Least Squares Mean
2675804|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of SBMs Per Week With no Straining|Straining during BMs was graded using the following scale: 0 = No straining; 1 = Mild straining; 2 = Moderate; 3 = Severe; 4 = Very Severe. A BM without straining was defined as a BM with a straining score of 0 or 1.|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||bowel movements/week||Standard Error|Least Squares Mean
2675805|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in Number of SBMs Rated as 3 or 4 on the Bristol Stool Scale Per Week|Consistency of BMs was measured using the Bristol Stool Scale, according to the following: 1 = separate hard lumps like nuts; 2 = sausage shaped but lumpy; 3 = like a sausage, but with cracks on its surface; 4 = like a sausage or a snake, smooth and soft; 5 = soft blobs and with clear-cut edges; 6 = floppy pieces with ragged edges/mushy stool; 7 = watery, no solid pieces, entirely liquid.|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.|||spontaneous bowel movements/week||Standard Error|Least Squares Mean
2675806|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of SBMs Per Week Rated as 3 or 4 on the Bristol Stool Scale|Consistency of BMs was measured using the Bristol Stool Scale, according to the following: 1 = separate hard lumps like nuts; 2 = sausage shaped but lumpy; 3 = like a sausage, but with cracks on its surface; 4 = like a sausage or a snake, smooth and soft; 5 = soft blobs and with clear-cut edges; 6 = floppy pieces with ragged edges/mushy stool; 7 = watery, no solid pieces, entirely liquid.|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||spontaneous bowel movements/week||Standard Error|Least Squares Mean
2675807|NCT01443403|Secondary|Percentage of Participants With CSBMs Within 4, 8, 12, and 24 Hours After the Initial Administration of Study Drug|The percentage of participants who experienced at least one CSBM within 4, 8, 12, and 24 hours after the initial administration of study drug and before the second administration.|4, 8, 12, and 24 hours|mITT population|||percentage of participants|||Number
2675808|NCT01443403|Secondary|Percentage of Participants With SBMs Within 4, 8, 12, and 24 Hours After the Initial Administration of Study Drug|The percentage of participants who experienced at least one SBM within 4, 8, 12, and 24 hours after the initial administration of study drug and before the second administration.|4, 8, 12, and 24 hours|mITT population|||percentage of participants|||Number
2675809|NCT01443403|Secondary|Time to the First Complete Spontaneous Bowel Movement|Time to the first CSBM was defined as the time to the first CSBM after the initial administration of study drug. Participants who withdrew from the study before a CSBM was observed or had no CSBM during the treatment period were treated as censored.|28 days|mITT population|||hours||95% Confidence Interval|Median
2675810|NCT01443403|Secondary|Time to the First Spontaneous Bowel Movement|Time to the first SBM was defined as the time to the first SBM after the initial administration of study drug. Participants who withdrew from the study before an SBM was observed or had no SBM during the treatment period were treated as censored.|28 days|mITT population|||hours||95% Confidence Interval|Median
2676002|NCT01442155|Primary|Disease-Free Survival (Time to Event)|Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of colon cancer, or death due to any cause).|Up to 3 years|Intent-to-treat (ITT) population included all participants treated with at least one dose of study drug. Here, number of participants analyzed is number evaluable for efficacy.|||months||95% Confidence Interval|Median
2675811|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3 and 4 in Number of Days Per Week With CSBMs|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation."|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.|||days/week||Standard Error|Least Squares Mean
2675812|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of Days Per Week With CSBMs|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||days/week||Standard Error|Least Squares Mean
2675813|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3 and 4 in Number of Days Per Week With SBMs|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~An SBM is defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement."|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.|||days/week||Standard Error|Least Squares Mean
2675814|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in Number of Days Per Week With SBMs|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~An SBM is defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||days/week||Standard Error|Least Squares Mean
2675815|NCT01443403|Secondary|Percentage of Participants With a CSBM Response at Weeks 1, 2, 3, and 4|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A CSBM responder was defined as a participant whose frequency of CSBMs during the treatment period was 3 times or more per week and who had an average increase in the frequency of CSBMs from baseline of 1 or more per week."|Baseline and Weeks 1, 2, 3, and 4|mITT population; missing data were imputed using last observation carried forward (LOCF).|||percentage of participants|||Number
2675816|NCT01443403|Secondary|Percentage of Participants With a CSBM Response in the Last 2 Weeks of the Treatment Period|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A CSBM responder was defined as a participant whose frequency of CSBMs within the last 2 weeks of the treatment period was 3 times or more per week and who had an average increase in the frequency of CSBMs from baseline of 1 or more per week."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||percentage of participants|||Number
2675817|NCT01443403|Secondary|Percentage of Participants With an SBM Response at Weeks 1, 2, 3 and 4|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~An SBM responder was defined as any participant whose frequency of SBM per week during the treatment period was 3 times or more per week, and who had an average increase from baseline of 1 or more per week."|Baseline and Weeks 1, 2, 3, and 4|mITT population; missing data were imputed using last observation carried forward (LOCF).|||percentage of participants|||Number
2675818|NCT01443403|Secondary|Percentage of Participants With an SBM Response in the Last 2 Weeks of the Treatment Period|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~An SBM responder was defined as a participant whose frequency of SBMs within the last 2 weeks of the treatment period was 3 times or more per week and who had an average increase in the frequency of SBMs from baseline of 1 or more per week."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||percentage of participants|||Number
2675819|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Complete Spontaneous Bowel Movements Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation."|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.|||complete spontaneous BMs per week||Standard Error|Least Squares Mean
2675820|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Spontaneous Bowel Movements (CSBMs) Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A CSBM was defined as a spontaneous BM which was accompanied by the feeling of complete evacuation."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||complete spontaneous BMs per week||Standard Error|Least Squares Mean
2675821|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Complete Bowel Movements Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A complete BM (CBM) was defined as a BM where the participant answered 'Yes' to the following question: 'Did you have a feeling of complete emptying after the bowel movement?'"|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.|||complete bowel movements per week||Standard Error|Least Squares Mean
2675822|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Complete Bowel Movements (CBMs) Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A complete BM (CBM) was defined as a BM where the participant answered 'Yes' to the following question: 'Did you have a feeling of complete emptying after the bowel movement?'"|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||complete bowel movements per week||Standard Error|Least Squares Mean
2676030|NCT01441882|Secondary|Objective Response|Proportion of patients achieving the endpoint along with its 95% exact binomial confidence interval will be presented.|Up to 2 years|||||||
2675823|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Bowel Movements Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A BM was defined as all bowel movements observed irrespective of the use of a laxative agent."|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.|||bowel movements per week||Standard Error|Least Squares Mean
2675824|NCT01443403|Secondary|Change From Baseline to the Last 2 Weeks of the Treatment Period in the Number of Bowel Movements (BMs) Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A BM was defined as all bowel movements observed irrespective of the use of a laxative agent."|Baseline and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|mITT population|||bowel movements per week||Standard Error|Least Squares Mean
2675825|NCT01443403|Secondary|Change From Baseline to Weeks 1, 2, 3, and 4 in the Number of Spontaneous Bowel Movements Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A spontaneous bowel movement was defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement. Baseline was defined as the average number of SBMs per day during the 2 weeks prior to randomization."|Baseline and Weeks 1, 2, 3, and 4|mITT population with values at both baseline and the specified time point.|||spontaneous bowel movements per week||Standard Error|Least Squares Mean
2675826|NCT01443403|Primary|Change From Baseline to Last 2 Weeks of the Treatment Period in the Number of Spontaneous Bowel Movements Per Week|"Participants completed a daily Bowel Movement and Constipation Assessment Diary to record information about bowel movements and constipation.~A spontaneous bowel movement was defined as a bowel movement unassisted by rescue medication (laxative or enema) taken within the 24 hours preceding the bowel movement. Baseline was defined as the average number of SBMs per week during the 2 weeks prior to randomization. The number of SBMs per week in the last 2 weeks of treatment is defined as the average number of SBMs per week recorded in the diary for the 14 days prior to the last dose of study drug."|Baseline (2 weeks prior to randomization) and the last 2 weeks of treatment (Weeks 3 to 4 for participants who completed the 28-day treatment period)|Modified intention-to-treat population|||spontaneous bowel movements per week||Standard Error|Least Squares Mean
2675827|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 0|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675828|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675829|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675830|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675831|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675832|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675833|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2676822|NCT01436279|Primary|Length of Procedure|Interval from speculum insertion to speculum removal|Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days.||||minutes||95% Confidence Interval|Mean
2675834|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675835|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675836|NCT01443364|Secondary|Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675837|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 0|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675838|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675839|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 2||||units on a scale||Full Range|Median
2675840|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675841|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675842|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675843|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675844|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675845|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2676823|NCT01436266|Primary|Blood Loss|500 cc or more|one day following the procedure||||Participants|||Count of Participants
2675846|NCT01443364|Secondary|Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675847|NCT01443364|Secondary|Bone Erosion at Week 0|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675848|NCT01443364|Secondary|Bone Erosion at Week 1|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675849|NCT01443364|Secondary|Bone Erosion at Week 2|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675850|NCT01443364|Secondary|Bone Erosion at Week 4|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675851|NCT01443364|Secondary|Bone Erosion at Week 6|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675852|NCT01443364|Secondary|Bone Erosion at Week 8|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675853|NCT01443364|Secondary|Bone Erosion at Week 12|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675854|NCT01443364|Secondary|Bone Erosion at Week 24|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675855|NCT01443364|Secondary|Bone Erosion at Week 36|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675856|NCT01443364|Secondary|Bone Erosion at Week 52|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675857|NCT01443364|Secondary|Cartilage Damage at Week 0|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675858|NCT01443364|Secondary|Cartilage Damage at Week 1|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675859|NCT01443364|Secondary|Cartilage Damage at Week 2|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675860|NCT01443364|Secondary|Cartilage Damage at Week 4|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675861|NCT01443364|Secondary|Cartilage Damage at Week 6|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675862|NCT01443364|Secondary|Cartilage Damage at Week 8|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675863|NCT01443364|Secondary|Cartilage Damage at Week 12|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675864|NCT01443364|Secondary|Cartilage Damage at Week 24|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675865|NCT01443364|Secondary|Cartilage Damage at Week 36|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675866|NCT01443364|Secondary|Cartilage Damage at Week 52|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675867|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 0|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675868|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 1|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675869|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 2|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675870|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 4|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675871|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 6|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675872|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 8|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675873|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 12|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675874|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 24|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675875|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 36|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675876|NCT01443364|Secondary|Doppler Signal and Blood Flow at Week 52|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675877|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 0|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 0 (Baseline)|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675878|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 1|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675879|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 2|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675880|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 4|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675881|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 6|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675882|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 8|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675883|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 12|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675884|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 24|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675885|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 36|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675886|NCT01443364|Secondary|Synovial Fluid and Proliferation at Week 52|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2676031|NCT01441882|Secondary|Incidence of Adverse Events Assessed According to the NCI Common Terminology Criteria for Adverse Events Version 4.0|Adverse events will be tabulated and summarized according to key reporting criteria (i.e., grade or seriousness, unanticipated, treatment attribution).|Up to 2 years||2019-07-31|07/2019||||
2675887|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675888|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675889|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675890|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675891|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675892|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675893|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675894|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675895|NCT01443364|Secondary|Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52|The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675896|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675897|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675898|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675899|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675900|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675901|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675902|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675903|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675904|NCT01443364|Secondary|Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52|The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675905|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 1|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675906|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 2|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675907|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 4|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675908|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 6|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675909|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 8|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675910|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 12|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675911|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 24|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675912|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 36|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675913|NCT01443364|Secondary|Change From Baseline in the Bone Erosion at Week 52|The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675914|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 1|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675915|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 2|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675916|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 4|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675917|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 6|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675918|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 8|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675919|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 12|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675920|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 24|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675921|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 36|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675922|NCT01443364|Secondary|Change From Baseline in the Cartilage Damage at Week 52|The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675923|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 1|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675924|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 2|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675925|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 4|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675926|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 6|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675927|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 8|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675928|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 12|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675929|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 24|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675930|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 36|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675931|NCT01443364|Secondary|Change From Baseline in the Doppler Signal and Blood Flow at Week 52|The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675932|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 1|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 1|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675933|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 2|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 2|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675934|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 4|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 4|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2676114|NCT01441076|Secondary|Physician Global Score|Global visual analogue scale administered by physicians with a range of score of 0-100. Lower scores indicate least symptoms and higher scores indicate worst symptoms faced by the patient.|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
2675935|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 6|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 6|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675936|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 8|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 8|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675937|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 12|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 12|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675938|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 24|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 24|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675939|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 36|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 36|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675940|NCT01443364|Secondary|Change From Baseline in the Synovial Fluid and Proliferation at Week 52|The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints, with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.|From Baseline to Week 52|Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).|||units on a scale||Full Range|Median
2675941|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 1 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 1 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.|||percentage of subjects||95% Confidence Interval|Number
2675942|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 2 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 2 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.|||percentage of subjects||95% Confidence Interval|Number
2675943|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 4 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 4 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.|||percentage of subjects||95% Confidence Interval|Number
2675944|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 6 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 6 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.|||percentage of subjects||95% Confidence Interval|Number
2675945|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 8 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 8 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.|||percentage of subjects||95% Confidence Interval|Number
2675946|NCT01443364|Primary|The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52|Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system|From Baseline to Week 12 and Week 52|The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.|||percentage of subjects||95% Confidence Interval|Number
2675947|NCT01443130|Secondary|Incidence of Infection in the Fetal Circulation|Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of positive for malaria cord blood smear and cord PCR results in maternal subjects based on the results of the thick smear and PCR from the cord blood sample.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all maternal participants with cord blood smears and cord PCR results obtained.|||percentage of participants||97.5% Confidence Interval|Number
2675948|NCT01443130|Secondary|Incidence of Clinical Malaria, All Species|Maternal participants were followed to outcome of the pregnancy. Clinical malaria is defined as malaria infection at any parasite density with associated symptoms including at least one of the following: objective fever measured at the clinic, history of fever in the past 48 hours or other symptoms in the last 48 hours including: headache, myalgia, vomiting, or weakness.|Enrollment to delivery (approximately 12-36 weeks)|The analysis population includes all maternal participants.|||percentage of participants||97.5% Confidence Interval|Number
2675949|NCT01443130|Secondary|Incidence of Malaria Infection, All Species.|Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of malaria infection episodes measured by positive parasitemia in maternal subjects.|Enrollment to delivery (approximately 12-36 weeks)|The analysis population includes all maternal participants.|||percentage of participants||97.5% Confidence Interval|Number
2675950|NCT01443130|Secondary|Incidence of Active Placental Malaria Infection|Maternal participants were followed to outcome of the pregnancy. This outcome measure provides the number of placental malaria infections in maternal subjects diagnosed by the presence of parasites and/or pigment on histological section or molecular evidence of infection (PCR).|At delivery: Approximately 12-36 weeks after enrollment|This analysis population includes all maternal subjects with placental slides reviewed and PCR results obtained.|||percentage of participants||97.5% Confidence Interval|Number
2675951|NCT01443130|Secondary|Incidence of Intrauterine Growth Restriction (IUGR)|Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants with IUGR at delivery. IUGR is defined as weight below the 10th percentile for gestational age based on the World Health Organization (WHO) fetal growth curve. This classification is supported by literature resulting from the INTERGROWTH-21st Project; José Villar.|At delivery: Approximately 12-36 weeks after enrollment|This analysis population includes all infants with weight captured at delivery and with mothers having reported gestational age at delivery.|||percentage of participants||97.5% Confidence Interval|Number
2675952|NCT01443130|Secondary|Incidence of Low Birth Weight (LBW) (Birthweight < 2500 Grams)|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of infants whose birthweight was less than 2500 grams.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all infants born alive with weight data collected at birth.|||percentage of infants||97.5% Confidence Interval|Number
2675953|NCT01443130|Secondary|Infant Mortality Rate to 14 Weeks of Age|Infants were followed from the time of delivery until 14 weeks of age. This outcome measure provides the incidence of infants who died within 14 weeks of delivery.|For 14 weeks after delivery.|The analysis population includes all enrolled infants.|||percentage of infants||97.5% Confidence Interval|Number
2675954|NCT01443130|Secondary|Incidence of Preterm Delivery|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was preterm delivery, defined as delivery less than 37 weeks of gestation. The outcome of the delivery was not considered, and could have been live birth, stillbirth, or miscarriage.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all participants whose pregnancies were followed to delivery.|||percentage of deliveries||97.5% Confidence Interval|Number
2675955|NCT01443130|Secondary|Incidence of Miscarriage|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was miscarriage, defined as an infant delivered without any signs of life at less than 28 weeks of gestation.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all maternal participants.|||percentage of pregnancies||97.5% Confidence Interval|Number
2675956|NCT01443130|Secondary|Incidence of Stillbirth|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of participants' deliveries whose outcome was stillbirth, defined as an infant born without any signs of life at 28 weeks or greater of gestation.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all participants whose pregnancies were followed to delivery.|||percentage of deliveries||97.5% Confidence Interval|Number
2675957|NCT01443130|Secondary|Incidence of Maternal Severe Anemia (Hemoglobin < 7gm/dl)|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of severe anemia among maternal participants during pregnancy. Severe anemia is defined as having a hemoglobin value less than 7 gm/dl.|From enrollment until delivery, approximately 12-36 weeks|The analysis population includes all maternal participants.|||percentage of maternal participants||97.5% Confidence Interval|Number
2675958|NCT01443130|Secondary|Incidence of Maternal Anemia (Hemoglobin < 10 Grams/Deciliter)|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of anemia among maternal participants during pregnancy . Anemia is defined as having a hemoglobin value less than 10 grams/deciliter (gm/dL).|From enrollment until delivery, approximately 12-36 weeks|The analysis population includes all maternal participants.|||percentage of maternal participants||97.5% Confidence Interval|Number
2675959|NCT01443130|Secondary|Incidence of Placental Malaria by Placental Impression Smear|Maternal participants were followed to outcome of the pregnancy. The outcome measure provides the incidence of malaria infection in the placenta based on diagnosis by positive placental impression smear results.|At delivery: Approximately 12-36 weeks after enrollment|The analysis population includes all maternal participants whose pregnancies were followed to delivery and from whom a placenta was collected and an impression smear performed.|||percentage of placentas||97.5% Confidence Interval|Number
2676115|NCT01441076|Secondary|Patient Global Score|Global visual analogue scale taken by patients with a range of score of 0-100. Lower scores indicate least symptoms and higher scores indicate worst symptoms faced by the patient.|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
2675960|NCT01443130|Primary|Incidence of Placental Malaria Infection Based on Histology|The placenta was collected at the time of delivery for examination by histology to determine malaria infection. Malaria infection was concluded if histology identified parasites or malaria pigment in the placental tissue.|At delivery: Approximately 12-36 weeks after enrollment|All participants from whom the placental histopathology slides collected at the time of delivery were reviewed are included in the analysis.|||percentage of pregnancies||97.5% Confidence Interval|Number
2675961|NCT01443078|Secondary|Pathologic Response Rate|The percentage of patients with a major pathologic response|2 years||||percentage of patients||95% Confidence Interval|Number
2675962|NCT01443078|Primary|PERCIST Partial Metabolic Response|"The primary endpoint was partial metabolic response after 2 cycles of switch therapy as assessed by PERCIST (SUVmax decrease ≥30% using the pre-switch scan as new baseline)."|2 years||||participants|||Number
2675963|NCT01443026|Secondary|Changes in Nuclear Morphometry|We will use a computerized image analysis system designed for the chemoprevention setting to test the hypothesis that the antioxidants cause a favorable change in a nuclear morphometry index based on nuclear size, shape and chromatin texture.|baseline and 6 months|||||||
2675964|NCT01443026|Primary|Changes in Serum Biomarkers|Change in serum lycopene, umol/L|baseline and 6 months||||umol/L||Full Range|Mean
2675965|NCT01443026|Primary|Tissue Biomarkers|We will use conventional immunohistochemistry and computer-based image analysis to test the hypothesis that the lycopene supplements alter the expression of proteins marking the status of proliferation, differentiation, cell regulation and apoptosis in high-risk tissue.|baseline and 6 months|||||||
2675966|NCT01442844|Primary|Percentage of Wound Re-epithelialization||4 weeks||||percentage of wound re-epithelialization||Full Range|Mean
2675967|NCT01442779|Secondary|Participants With Change in Cough|changes in cough status after treatment for 1 month.|1 month|During the course of the study it was noted that subjects experienced a change in the cough that is sometimes associated with IPF. The 6 subjects still enrolled in the study were asked to complete a questionnare regarding the status of the cough.|||Participants|||Number
2675968|NCT01442779|Primary|Minimal/no Change in Quality of Life||12 months|Analysis was performed only on those subject who continue on medication for at least one year.|||Participants|||Number
2675969|NCT01442779|Primary|Minimal/no Progression (1 yr) by High Resolution Computed Tomography (HRCT) & Pulmonary Function|Disease progression was determined by comparing results of the High Resolution Computed Tomography(HRCT) and pulmonary function at one year to the baseline HRCT & pulmonary function. The same radiologist did the comparsion for all subjects.|1 yr||||Participants|||Number
2675970|NCT01442714|Secondary|Overall Survival|Survival was measured from the 1st day of azacitidine treatment to death from any cause.|462 Days||||months||95% Confidence Interval|Median
2675971|NCT01442714|Secondary|Median Duration of Response|The median duration of response was defined by the median duration of response for participants with Complete Response (CR); CR with incomplete count recovery (CRi); or Partial Response (PR).|203 days||||days||95% Confidence Interval|Median
2675972|NCT01442714|Primary|Overall Response Rate (ORR)|Overall response rate was defined as the sum of Complete Response (CR) + CR with incomplete count recovery (CRi) + Partial Response (PR).|203 days||||Participants|||Count of Participants
2675973|NCT01442688|Primary|Maximum Plasma Concentration (Cmax) for Amoxicillin|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set|||ug/ml||Standard Deviation|Mean
2675974|NCT01442688|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for Amoxicillin|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Assessed over a 24-hour period starting post-dose on day 4|The Pharmacokinetic Analysis Set was defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. The Safety Analysis Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.|||h*ug/ml||Standard Deviation|Mean
2675975|NCT01442675|Secondary|Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra®|Solicited injection-site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection-site reactions: Pain - Significant, prevents daily activity; Erythema and Swelling - >100 mm. Grade 3 systemic reactions: Fever - ≥40˚C or ≥104˚F; Headache, Malaise, Myalgia, and Shivering - Significant, prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
2675976|NCT01442675|Secondary|Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®|Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.|Day 6 and Day 28 post-vaccination|Geometric mean titers ratios (GMTRs) were assessed in the Per-protocol Analysis Set. Serum samples were also collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC GMTRs at this time point.|||Titers ratio||95% Confidence Interval|Geometric Mean
2675977|NCT01442675|Secondary|Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®|Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.|Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination|Geometric mean titers (GMTs) were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC GMTs at this time point.|||Titers||95% Confidence Interval|Geometric Mean
2675978|NCT01442675|Secondary|Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®|Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.|Day 6 and Day 28 post-vaccination|SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.|||Participants|||Number
2675979|NCT01442675|Secondary|Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®|"Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC).~Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point."|Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination|SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.|||Participants|||Number
2675980|NCT01442675|Secondary|Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®|"Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC).~Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point."|Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination|SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point.|||Participants|||Number
2675981|NCT01442675|Primary|Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®|Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC)|Day 28 post-vaccination|SBA-HC antibody titers were assessed in the Per-protocol Analysis Set.|||Participants|||Number
2675982|NCT01442493|Secondary|Number of Participants Meeting DSM-IV Cocaine Dependence Criteria|Number of participants meeting DSM-IV cocaine dependence criteria|12-months post-baseline|Baseline values were used when 12 month data were missing|||Participants|||Count of Participants
2675983|NCT01442493|Secondary|Number of Participants Meeting DSM-IV Opiate Dependence Criteria|Diagnostic and Statistical Manual (DSM)-IV criteria for opiate dependence|12-months post-baseline|Baseline values were used when 12 month data were missing|||Participants|||Count of Participants
2675984|NCT01442493|Secondary|Global Score on the World Health Organization Quality of Life Measure|Scale from 1 through 5. A higher score reflects a better quality of life.|12-months post-baseline|Baseline values were used when 12 month data were missing|||units on a scale||Standard Deviation|Mean
2675985|NCT01442493|Secondary|Criminal Behavior|Days of criminal behavior|12-months post-baseline||||Number of Days in the Past 30 days||Standard Deviation|Mean
2675986|NCT01442493|Secondary|Drug Use HIV Risk Behavior|HIV Drug Use Risk Assessment Battery Score ranges from 0 to 22. A higher score is considered to be associated with higher risk.|12-months post-baseline|Baseline values were used when 12 month data were missing.|||units on a scale||Standard Deviation|Mean
2675987|NCT01442493|Secondary|Number of Participants With Cocaine Positive Urine Tests|Cocaine positive urine drug test|12-months post-baseline|Missing data were considered positive|||Participants|||Count of Participants
2675988|NCT01442493|Primary|Number of Participants With Opiate Positive Urine Tests|Number of participants with opiate positive urine tests|12-months post-baseline|Missing data were counted as positive|||Participants|||Count of Participants
2675989|NCT01442376|Secondary|Proportion of Patients With Complete Response >24 to 120 Hours (Delayed Phase) in Cycle 1|Complete Response (CR) was defined as no vomiting, no retching, and no use of antiemetic rescue medication from >24 to 120 hours (delayed phase) after T0 (start of administration of the most emetogenic chemotherapy) during first cycle.|from >24 to 120 hours (delayed phase) after T0|Full Analysis Set (FAS) population.|||percentage of patients||95% Confidence Interval|Number
2675990|NCT01442376|Primary|Proportion of Patients With Complete Response 0 to 24 Hours (Acute Phase) in Cycle 1|Complete Response (CR) was defined as no vomiting, no retching, and no use of antiemetic rescue medication from 0 to 24 hours (acute phase) after T0 (start of administration of the most emetogenic chemotherapy) during first cycle. Time 0 (T0) is defined as the time when the patient starts the first cycle of chemotherapy.|0 to 24 hours after T0|Full Analysis Set (FAS) population|||percentage of patients||95% Confidence Interval|Number
2675991|NCT01442181|Other Pre-specified|Directed Fluency, Animals|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The participant is asked to name as many animals as possible beginning with a letter, for one minute.|Change in Baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||animals||Standard Deviation|Mean
2675992|NCT01442181|Other Pre-specified|Stroop Word Test|"Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Only 9 patients in the minimally invasive surgery arm completed the stroop word test, and only 6 patients in the medical therapy group completed the stroop word test.~In this test, subjects are asked to read a list of words. 100 is the maximum amount of correct responses per trial."|Change in Baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||words||Standard Deviation|Mean
2675993|NCT01442181|Other Pre-specified|Wtar (Wechsler Test of Adult Reading) Word List|"Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation).~The WTAR is composed of 50 irregularly spelled words and takes approximately 10 minutes to complete. The examiner begins by presenting the first word card and prompting the patient for a single pronunciation of the word. This procedure continues through all 50 word cards and is discontinued if the patient provides 12 consecutive incorrect pronunciations. Each correct pronunciation is given a score of 1, with 50 as the maximum raw score."|Baseline|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||words||Standard Deviation|Mean
2675994|NCT01442181|Other Pre-specified|Stroop Color Test|"Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Only 9 patients in the minimally invasive surgery arm completed the stroop color test, and only 6 patients in the medical therapy group completed the stroop color test.~In this test, subjects are asked to read a list of color words. 100 is the maximum amount of correct responses per trial."|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||colors||Standard Deviation|Mean
2675995|NCT01442181|Other Pre-specified|Hopkins Verbal Learning Test Version A|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). This test measures word recognition. 12 words are read to the subject and they have to repeat as many as they can recall. There are 4 trials, each with 12 total possible words.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||words||Standard Deviation|Mean
2675996|NCT01442181|Other Pre-specified|Directed Fluency; Cowa (Controlled Oral Word Association Test)|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The participant is asked to name as many words as possible beginning with a letter, excluding proper nouns, for one minute and this procedure is repeated three times.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||words||Standard Deviation|Mean
2675997|NCT01442181|Other Pre-specified|Montreal Cognitive Assessment (Moca)|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The score is 0 - 30 point test with the higher the score the better cognitive function.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||units on a scale||Standard Deviation|Mean
2675998|NCT01442181|Other Pre-specified|STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory)|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Scores range from 20 to 80, with higher scores correlating with greater anxiety.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||units on a scale||Standard Deviation|Mean
2675999|NCT01442181|Other Pre-specified|STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory)|Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Scores range from 20 to 80, with higher scores correlating with greater anxiety.|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||units on a scale||Standard Deviation|Mean
2676000|NCT01442181|Primary|Quality of Life RAND 36-Item Health Survey|"Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation).~The RAND 36-Item Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores which will have a 0 to 100 range."|Change in baseline, 3 month, and 6 month|Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.|||units on a scale||Standard Deviation|Mean
2676001|NCT01442155|Secondary|Safety: Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Up to 3 years|Safety population included all participants treated with at least one dose of study drug.|||percentage of participants|||Number
2677083|NCT01435031|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|3 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2676003|NCT01442129|Secondary|Functional Status and Ventricular Function|"The key efficacy endpoint of this study is functional status and ventricular function, while weaned from LVAD support, at 90 days post intervention (LVAD implantation + intramyocardial injection of study product). Functional status is defined by the ability to tolerate wean from LVAD support for 30 minutes without signs or symptoms of hypoperfusion, including, but not limited to symptoms of low output or signs of vascular congestion. Ventricular function will be assessed by transthoracic echocardiogram (TTE) in those patients able to be weaned for 30 minutes from LVAD support.~The number of participants who successfully tolerated the 30 minute wean from LVAD support at 90 days is reported."|90 days||||participants|||Number
2676004|NCT01442129|Primary|Intervention Related Adverse Events|The primary safety endpoint of this study is the incidence of the following potential study-intervention related adverse events within 90 days post intervention (LVAD implantation + intramyocardial injection of study product): infectious myocarditis, myocardial rupture, neoplasm, hypersensitivity reaction, and immune sensitization.|90 days||||events|||Number
2676005|NCT01442103|Secondary|Pain Upon Application of Investigational Product.|VAS pain scale will be used to measuring pain at each dressing change.|4 weeks|||||||
2676006|NCT01442103|Secondary|Infection Assessment|Erythema, edema, warmth, increased drainage, foul odor and fever will be assessed at each visit.|4 weekks|||||||
2676007|NCT01442103|Primary|Resolution of Signs and Symptoms of Local Wound Infection/Inflammation.|Signs and symptoms of local wound infection/inflammation will be assessed by visual infection assessment (including body temperature) and wound status.|4 weeks|Popul for the asses.of safety was incld all subjs that received at least one device and that provided data after baseline. Prim.analys:ITT, popul incld all subjs that provid.data for the prim endpoint Parameters were summ for the ITT popul using apt sum. statistics. Data described in a descriptive manner only. Efficacy endpoints were sum.by visit.|||participants|||Number
2676008|NCT01442064|Secondary|Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25)|"NEI VFQ-25 is a 25 item questionnaire that assesses visual function and quality of life for a total possible score of 0 to 100. A higher score represents better functioning. The change from baseline is calculated at Month 12 and Month 24.~Participants are grouped according to the treatment they received in initial studies FVF4165g BRAVO (NCT00486018) and FVF4166g CRUISE (NCT00485836)."|Baseline (Day 0 of extension study), Months 12 and 24|"Enrolled participants for whom data was available for analyses at the given time-points. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n."|||Scores on a scale||Standard Deviation|Mean
2676009|NCT01442064|Secondary|Change From Baseline in Central Foveal Thickness at Month 6 and Month 12|Change from baseline in Central foveal (retinal) thickness was assessed by Optical Coherence Tomography (OCT). OCT was conducted at the study sites by personnel who were certified by the University of Wisconsin Fundus Photograph Reading Center.|Baseline (Day 0 of extension study), Months 6 and 12|"Enrolled participants for whom data was available for analyses at the given time-point as indicated by n in the categories. Observed data were used with no imputation."|||µm||Standard Deviation|Mean
2676010|NCT01442064|Secondary|Change From Baseline in the Best Corrected Visual Acuity (BCVA)|Change from baseline in then BCVA was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a Starting Test Distance of 4 Meters. An increase in the number of letters read indicates improvement in visual acuity.|Baseline (Day 0 of extension study), Months 6, 12, 18, and 24|"Enrolled participants for whom data was available for analyses at the given time-points. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by n."|||letters||Standard Deviation|Mean
2676011|NCT01442064|Primary|Number of Participants With Non-ocular Adverse Events|"Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death.~Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.~Additional information about adverse events can be found in the adverse events section."|Up to 24 months|Ranibizumab- Treated Participants includes all participants who received Ranibizumab in one of the initial studies or this extension study. This analysis includes only those adverse events that occurred during this extension study.|||participants|||Number
2676012|NCT01442064|Primary|Number of Participants With Ocular Adverse Events in the Study Eye|"Number of participants with: any ocular adverse events, ocular adverse events causing treatment discontinuation, ocular serious adverse events, intraocular inflammation and cataracts that occurred in the study eye.~Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded."|Up to 24 months|Ranibizumab- Treated Participants includes all participants who received Ranibizumab in one of the initial studies or this extension study. This analysis includes only those adverse events that occurred during this extension study.|||participants|||Number
2676013|NCT01442038|Secondary|Kaplan-Meier Estimates for Time From Randomization to Myocardial Infarction|Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.|Baseline through end of study (average 90 weeks)|Full Analysis Set|||percentage of participants|||Number
2676014|NCT01442038|Secondary|Kaplan-Meier Estimates for Time From Randomization to Cardiovascular Death|Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.|Baseline through end of study (average 90 weeks)|Full Analysis Set|||percentage of participants|||Number
2676015|NCT01442038|Secondary|Kaplan-Meier Estimates for Time From Randomization to Sudden Cardiac Death|Time to event distributions were estimated by the Kaplan-Meier method. 1 month = 28 days; 1 calendar year = 365 days.|Baseline through end of study (average 90 weeks)|Full Analysis Set|||percentage of participants|||Number
2676116|NCT01441076|Secondary|Number of Oral Ulcers by Physician Evaluation|Number of oral ulcers noted by physician evaluation|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||oral ulcers in participants||Full Range|Median
2676016|NCT01442038|Primary|Kaplan-Meier Estimates for Time From Randomization to First Occurrence of Ischemia-driven Revascularization or Ischemia-driven Hospitalization Without Revascularization|Time to event distributions were estimated by the Kaplan-Meier (KM) method. 1 month = 28 days; 1 calendar year = 365 days.|Baseline through end of study (average 90 weeks)|Full Analysis Set: all participants in the Safety Analysis Set (randomized and received at least one dose of study drug), except participants with no qualifying percutaneous coronary intervention (PCI; formerly known as angioplasty with stent))|||percentage of participants|||Number
2676017|NCT01441973|Secondary|Objective Response Rate (ORR)|ORR is defined as the number of participants with stringent compete response [SCR], complete response [CR], very good partial response [VGPR], and partial response [PR])/number of participants in arm, expressed as a percentage. Confidence intervals computed using the Clopper and Pearson method. SCR=CR plus normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. CR=Negative immunofixation on serum and urine and 5% or fewer plasma cells in bone marrow. VGPR=Serum and urine monoclonal (M) protein detectable by immunofixation but not on electrophoresis or 90% reduction in serum M protein level plus urine M protein level <100 mg/24 hour. PR=50% reduction of serum M protein and reduction in 24-hour urinary M protein by 90% or to <200 mg/24 hour|From first dose to date of progression or objective response (assessed up to August 2017, approximately 59 months)|All treated participants|||Percentage of participants||90% Confidence Interval|Number
2676018|NCT01441973|Secondary|Progression Free Survival (PFS) Rate|The probability was estimated from the K-M curve of subjects being alive and without disease progression (modified IMWG criteria) at 2 years from the initiation of study therapy by dose cohort|Up to 2 years from the initiation of study therapy by dose cohort (approximately 24 months)|All treated participants|||Probability of Progression Free Survival||90% Confidence Interval|Number
2676019|NCT01441973|Secondary|Number of Participants With a Dose- or Concentration-related Effect on QTcF Interval, PR Interval, QRS Interval, and Heart Rate|All on-treatment electrocardiograms (ECGs) were performed in triplicates ( 1 ECG test equaled 3 consecutive individual 12-lead ECGs performed within a 4-minute period). The timing of the ECG was critical to the endpoint of the study. The investigative site documented any deviations from the protocol or procedures related to ECG collection or serum sampling. No ECGs were excluded due to timing deviations; no deviations were considered clinically relevant and all ECG data were included.|cycle 1 to first day of cycle 3 assessed up to 08/17, approximately 59 months|All participants who received at least 1 dose of study drug|||Participants|||Number
2676020|NCT01441973|Secondary|Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality|Clinical laboratory evaluations included hematology, chemistry, and liver and renal functioning.|From date of first dose to date of last dose plus 60 days (assessed up to August 2017, approximately 59 months|All participants who received at least 1 dose of study drug|||Participants|||Number
2676021|NCT01441973|Primary|Linear Regression of Maximal Percent Reduction in Serum Monoclonal (M) Protein on Baseline Percent CD56^Dim Cells in Bone Marrow|Estimated using linear regression model, with baseline CD56^dim cells as the independent covariate, and maximal percent reduction in serum M protein as the dependent variable. For 1 patient who had nonmeasurable disease at baseline, the percent change in serum kappa-lambda difference was used instead of the percent change in serum M protein. Unit of measure=percent change from baseline in M protein cells/ percent change in CD56^dim cells (% chg from BL in M pro/% chg CD56^dim cs)|From day of last patient, first dose to 6 months|All participants who received at least 1 dose of study drug and had the required data (4 participants did not have baseline data available).|||% chg from BL in M pro/% chg CD56^dim cs||95% Confidence Interval|Number
2676022|NCT01441973|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Infusion Reactions|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|From day of last patient, first dose to 6 months|All participants who received at least 1 dose of study drug|||Participants|||Number
2676023|NCT01441960|Secondary|Differences in Seizure Duration Between Compounds|Observational reports suggest that differences in seizure duration might exist depending on the neuromuscular blocking agents used to accomplish muscle strength control during ECT.|Up to six weeks following inclusion||||Seconds||Standard Deviation|Mean
2676024|NCT01441960|Secondary|Compound Specific Differences in Time to Recovery From Neuromuscular Blockade|The investigators defined the compound specific differences in time to recovery from neuromuscular blockade - i.e., recovery of spontaneous breathing and recovery of the twitch height to baseline.|Up to six weeks following inclusion||||minutes||Standard Deviation|Mean
2676025|NCT01441960|Primary|Optimal Dose of Neuromuscular Blocking Agent During ECT|The optimal dose of muscle neuromuscular blocking is defined as the lowest dose of either compound that predicts 'acceptable' control of muscle strength during ECT. Assessment of the primary end point is based on a dichotomous scale 'acceptable' and 'not acceptable' control of muscle strength during ECT, and the two assessors will be blinded to the dose of neuromuscular blocking agent. The optimal dose was identified for each subject, and results were reported as the average of all lowest doses collected in the study.|Up to six weeks following inclusion||||mg.kg-1||95% Confidence Interval|Mean
2676026|NCT01441882|Other Pre-specified|Biomarker Analysis of SRC, TEC, or BTK Family Kinase Inhibition|Use of either t-test (normally distributed variables) or Wilcoxon rank sum test (non-normally distributed variables) to determine whether the mean of continuous biomarkers or patient factors (e.g., IC50 dasatinib cytotoxicity, SRC family kinase inhibition level, TEC family kinase inhibition level, disease risk such as the presence or absence of poor risk features as defined in the protocol) are significantly different between responders and non-responders.|Up to 2 years|||||||
2676027|NCT01441882|Secondary|Target Response Rate|Proportion of patients achieving the endpoint along with its 95% exact binomial confidence interval will be presented.|Up to 2 years|||||||
2676028|NCT01441882|Secondary|Progression-free Survival|Kaplan-Meier method will be used to estimate the survival curve.|Up to 2 years|||||||
2676029|NCT01441882|Secondary|Overall Survival|Kaplan-Meier method will be used to estimate the survival curve.|Up to 2 years|||||||
2676032|NCT01441882|Primary|In Vitro Dasatinib Sensitivity in Predicting Clinical Activity|Defined by a decrease in absolute lymphocyte count, as determined by peripheral blood complete blood count (CBC) with differential or by bone marrow examination of 50 % and/or a decrease of detectable total lymph node size or spleen size by 50% (either by clinical examination contrast enhanced computed tomography [CT]). Summarized using descriptive statistics (e.g., proportions for categorical variables, and mean/standard deviation for continuous variables).|8 weeks|Five patients met the primary objective. Four patients had a decrease in absolute lymphocyte count (peripheral blood complete blood count (CBC) with differential or by bone marrow examination of 50%), 4 patients had a decrease of detectable total lymph node size by 50%, and no patients had a decrease in spleen size by 50%.|||Participants|||Count of Participants
2676033|NCT01441843|Secondary|Somatic Symptoms and Complaints|Medical records are used to assess somatic symptoms and complaints. Next to the medical records, dimensions of the QoR-40 (physical comfort, physical independence and pain) are used to measure somatic symptoms and complaints.|Baseline; first postoperative working day; 1 week after surgery|||||||
2676034|NCT01441843|Secondary|Depressive Mood|The Hospital Anxiety and Depression Scale (HADS) is used to assess the change in depression. The HADS is a well known international outcome measurement for anxiety and depression. It is often used in the clinical setting. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of depression.|baseline; 1 week after surgery|||||||
2676035|NCT01441843|Secondary|Aggression Regulation|The State-Trait Anger Scale (STAS) is used to assess the aggression regulation. STAS is one of the most used tools for measuring aggression. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of aggression|baseline; 1 week after surgery|||||||
2676036|NCT01441843|Secondary|Fatigue|The Multidimensional Fatigue Inventory (MFI) is used to assess the change in fatigue. The MFI is a self-report instrument designed to measure fatigue. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of fatigue.|baseline; 1 week after surgery|||||||
2676037|NCT01441843|Secondary|Anxiety|The State-Trait Anxiety Inventory (STAI) is used to assess anxiety. Scores are calculated by summing the scores on the items, and a higher score indicates a higher level of anxiety.|baseline; after surgery but before discharge; 1 week after surgery|||||||
2676038|NCT01441843|Primary|Quality of Recovery Score|"The Quality of Recovery Score - 40 (QoR-40), a 40-item scale, is used to assess the quality of recovery.~Each item is rated on a five-point Likert scale (1-5), and the QoR-40 score is calculated as the sum of the scores on these items. Minimal possible score = 40, maximal possible score = 200. A higher score indicates a higher level of quality of recovery."|Baseline; first postoperative working day; seventh postoperative day.||||scores on a scale||Standard Deviation|Mean
2676039|NCT01441765|Secondary|Number of Participants Who Survived at 2 Years|To evaluate overall survival following treatment with CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine.|2 years||||participants|||Number
2676040|NCT01441765|Secondary|Effect on Circulating Regulatory T Cells|To evaluate the effect of CT-011 alone or in conjunction with DC/RCC fusions on circulating regulatory T cells and PD-1 expression by circulating and bone marrow derived T cells.|2 years|Data was not analyzed as so few participants were enrolled and no participants achieved a PR.||||||
2676041|NCT01441765|Secondary|Immunologic Response|To evaluate immunologic response directed against RCC and tumor specific antigens following therapy with CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine. Immunologic response will be characterized as peak response post-therapy and ongoing response at 3 and 6 months following treatment.|2 years|Data was not analyzed as so few participants were enrolled and none of the participants achieved a PR or CR.||||||
2676042|NCT01441765|Primary|Number of Participants With PR or CR at 2 Years|"To evaluate the complete and partial response rate following completing 4 cycles of CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, (with an absolute increase of at least 5 mm), or the appearance of new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|2 years||||participants|||Number
2676043|NCT01441765|Primary|Number of Participants With Adverse Events|Assessment of toxicity associated with treating patients with metastatic RCC with CT-011 alone or CT-011 in conjunction with DC/RCC. Toxicity was assessed and classified according to CTCAE Version 4.0.|2 years||||participants|||Number
2676044|NCT01441596|Secondary|Overall Survival|Overall Survival is defined as time from randomisation to the date of death from any cause.|From first drug administration until 28 days after end of treatment, up to 805 days|RS including only patients who died|||weeks||Inter-Quartile Range|Median
2676045|NCT01441596|Secondary|Progression-Free Survival|"Progression-Free Survival is defined as the time from the date of randomisation to the date of disease progression or death whichever came first.~Disease progression was defined as either disease progression in CNS lesions (including worsening in NSS and use of corticosteroid) or disease progression in extra-CNS lesions according to RECIST 1.1."|From first drug administration until 28 days after end of treatment, up to 805 days|RS including only patients who experienced disease progression or death|||weeks||Inter-Quartile Range|Median
2676046|NCT01441596|Primary|Patient Benefit Rate at 12 Weeks|Percentage of patients with patient benefit at week 12. Patient benefit was defined by the absence of central nervous system (CNS) disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in addition to no tumour-related worsening of the neurological signs and symptoms (NSS), no tumour-related increase in corticosteroid dosage and no progression of extra CNS disease according to RECIST 1.1|12 weeks from randomisation|Randomised Set (RS): includes all randomised patients, whether treated or not.|||percentage of participants||95% Confidence Interval|Number
2676047|NCT01441570|Secondary|Blood Pressure|Evaluate the baseline and follow-up systolic and diastolic blood pressures for all subjects in both groups.|12 weeks||||mmHg||Standard Deviation|Mean
2676048|NCT01441570|Primary|Quality of Life|"Primary outcome measure will be the change from the Screening/Enrollment Visit to the End of the Study/Early Termination visit in scores of four quality of life questionnaires. The four quality of life questionnaires that were used included the following:~Short Form (SF)-36v2 Health Survey (Score Range = 0-100; the lower the score the more disability)~Sexual Dysfunction Tool for Men = International Index of Erectile Function (IIEF) Questionnaire (Score Range = 5-25; a score of 22-25 = No erectile dysfunction; 17-21 = Mild erectile dysfunction; 12-16 = Mild to moderate erectile dysfunction; 8-11 = Moderate erectile dysfunction; 5-7 = Severe erectile dysfunction)~Sexual Dysfunction Tool for Women = Changes in Sexual Functioning Questionnaire (CSFQ-14-F; Score Range = 14-70; a score at or below 42 is indicative of sexual dysfunction)~Multidimensional Assessment of Fatigue (MAF) Scale (Score Range = 1-50; the higher the score the more fatigue)"|12 weeks; Baseline scores were measured at the Initial Screening/Enrollment Visit (Visit 1 - beginning of week 1); Follow-Up scores were measured at the End of the Study (Visit 2 - End of week 12)|Adult (>18 years of age) renal transplant recipients, both men and women, requiring pharmacotherapy for high blood pressure were evaluated for inclusion in this analysis.|||units on a scale||Standard Deviation|Mean
2676049|NCT01441466|Secondary|Cross-infection|nosocomially acquired cross-infection|measured until 1 week after hospital exit||||participants|||Number
2676050|NCT01441466|Secondary|Mechanical Ventilation|Mechanical ventilation and endotracheal intubation needed|duration of hospitalisation, an average of 3-4 days||||participants|||Number
2676051|NCT01441466|Secondary|Highest Dyspnoea Score|highest dyspnoea score (0-10) recorded during admission (0 is no dsypnoea, 10 is highest dyspnoeascore, thus the worst)|duration of hospitalisation, an average of 3-4 days||||units on a scale (0-10)||Standard Deviation|Mean
2676052|NCT01441466|Secondary|Supplemental Oxygen Needed|number of days that supplemental oxygen was needed|duration of hospitalisation, an average of 3-4 days||||days||Standard Deviation|Mean
2676053|NCT01441466|Secondary|Number of Days With Tube Feeding|number of days the patient has been tube fed|duration of hospitalisation, an average of 3-4 days||||days||Standard Deviation|Mean
2676054|NCT01441466|Primary|Duration of Hospital Stay||duration of hospitalisation, an average of 3-4 days||||days||Standard Deviation|Mean
2676055|NCT01441440|Secondary|Mean Clinical Global Impression - Improvement (CGI-I) Score at Week 8 or Early Termination|CGI-I is a 7-point clinician rated scale ranging from 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, to 7=very much worse. Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Scores above 4 reflect worsening of illness state as compared to baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.|||Units on a scale||Standard Error|Mean
2676056|NCT01441440|Secondary|Changes From Baseline in 16-item Quick Inventory of Depressive Symptomatology Self-Report Japanese Version (QIDS16-SR-J) Total Score at Week 8 or Early Termination|QIDS16-SR-J is a self-rated scale used in patients with major depressive disorder to measure the overall severity of depressive symptoms: 1) sad mood; 2) concentration; 3) self-criticism; 4) suicidal ideation; 5) interest; 6) energy/fatigue; 7) sleep disturbance (initial, middle, and late insomnia or hypersomnia); 8) decrease/increase in appetite/weight; and 9) psychomotor agitation/retardation. QIDS16-SR-J items are rated on a scale of 0 to 3. The total score ranges from 0 to 27, and higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.|||Units on a scale||Standard Error|Mean
2676057|NCT01441440|Secondary|Changes From Baseline in 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score at Week 8 or Early Termination|HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.|||Units on a scale||Standard Error|Mean
2676058|NCT01441440|Secondary|Changes From Baseline in Clinical Global Impression-Severity (CGI-S) at Week 8 or Early Termination|CGI-S is a 7-point clinician rated scale to assess severity of participant's current illness state; range: 1=normal, not ill at all, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients. Higher scores reflect higher severity of current illness states. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.|||Units on a scale||Standard Error|Mean
2676059|NCT01441440|Secondary|Changes From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8 or Early Termination|MADRS is a scale used in subjects with major depressive disorder to measure the overall severity of depressive symptoms. It is a 10 item, clinician-rated scale that assesses treatment-sensitive change by evaluating ten areas of depressive symptomatology: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts. The items are rated on a 7 point Likert scale (0 - 6) with anchors at 2 point intervals. The total score ranges from 0 to 60, and higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.|||Units on a scale||Standard Error|Mean
2676819|NCT01436279|Secondary|Pain Medication (Fentanyl) During the Abortion|Amount of pain medication used during the procedure: reported as micrograms of fentanyl|Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.||||mcg||Standard Deviation|Mean
2676060|NCT01441440|Primary|Change From Baseline in 17-item Hamilton Raing Scale for Depression (HAM-D17) Total Score at Week 8 or Early Termination|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 or 0 to 4, and the total score ranges from 0 to 52. Higher scores indicate more severe symptoms. Change from baseline: mean score at Week 8 or early termination minus mean score at baseline.|Baseline, Week 8 or Early termination|Participants randomly assigned to treatment who took at least one dose of the study drug in the double-blind period and who had both baseline and at least one post-baseline measurements of the primary efficacy variable.|||Units on a scale||Standard Error|Mean
2676061|NCT01441414|Secondary|Overall Survival (OS) at 2 Years|OS is defined as the time from the first dose date to date of death. For participants not expiring, their survival times will be censored at the last date they are known to be alive, or 2 year whichever is earlier. The 2-year OS rate will be estimated from a time-to event analysis of OS.|5 years|This endpoint was not assessed due to the early termination of the study.||||||
2676062|NCT01441414|Secondary|Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) as Measured by an Independent Radiological Assessment|PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first. PFS was to be calculated as (first event date - the date of randomization +1).|3 years|This endpoint of estimating median PFS was not assessed due to early termination of the study.||||||
2676063|NCT01441414|Secondary|Number of Anti-drug Antibodies (ADA) Samples Confirmed Positive|Detection of neutralizing anti-PF-04856884 antibodies was based on the ability of anti-PF-04856884 neutralizing antibodies to bind to Tag-PF-04856884.|0 and 360 hours post dose and end of study|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.|||ADA samples|ADA samples||Number
2676064|NCT01441414|Secondary|Cmin (Trough PF-04856884 Serum Concentration)|Pharmacokinetic parameter Cmin (trough PF-04856884 serum concentration) was estimated using noncompartmental methods.|Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.|||ng/mL||Standard Deviation|Mean
2676065|NCT01441414|Secondary|Cmax (Observed Peak Serum PF-04856884 Concentration)|Pharmacokinetic parameter Cmax (observed peak PF-04856884 serum concentration) was estimated using noncompartmental methods.|Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.|||ng/mL||Standard Deviation|Mean
2676066|NCT01441414|Secondary|Tmax (Time When Maximum Serum PF-04856884 Concentration Was Reached)|Pharmacokinetic parameter, Tmax (Time when maximum serum PF-04856884 concentration was reached) was done using non-compartmental methods.|Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.|||hr||Standard Deviation|Mean
2676067|NCT01441414|Secondary|Duration of Response (DR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone|DR is defined as the time from the first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the first documentation of tumor progression or to death due to cancer. Duration of tumor response was to be calculated as (the end date for DR − first CR or PR that is subsequently confirmed +1).|3 years|This endpoint was not assessed due to the early termination of the study.||||||
2676068|NCT01441414|Secondary|Overall Response Rate (ORR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone.|ORR is defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to all randomized participants as defined in the FA Set. Confirmed responses are those that persist on repeat imaging study ≥ 4 weeks after initial documentation of response. Participants who do not have on-study radiographic tumor evaluation or who die, progress, or drop out for any reason prior to reaching a CR or PR will be counted as non-responders (NR) in the assessment of ORR.|4 months|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.|||Percentage of participants|||Number
2676069|NCT01441414|Secondary|Number of Participants With Non-serious AEs and SAEs|Incidence and severity of all-causality AEs and SAEs to be presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).|3 years|This endpoint was not assessed due to the early termination of the study.||||||
2676070|NCT01441414|Primary|Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) in Part II|PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first. Progression free survival was to be calculated as (first event date - the date of randomization +1).|3 years|The primary efficacy endpoint of estimating median PFS in Part II was not assessed due to early termination of the study.||||||
2676079|NCT01441401|Secondary|Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline|Participants who responded to the treatment with gabapentin were counted by the number of concomitant epileptic drugs at baseline across 5 categories (no drug, 1 drug, 2 drugs, 3 drugs, and 4 or more drugs) to assess whether the number of concomitant epileptic drugs at baseline was a factor affecting the treatment efficacy.|MAX 104 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.|||Participants|||Number
2676071|NCT01441414|Primary|Number of Participants With Serious Adverse Events (SAEs) in Part I|Incidence and severity of all-causality serious adverse events (SAEs) are presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). Participants with treatment-related TEAE are coded as NA if they appear for the same preferred term under all-causality TEAE.|4 months|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.|||participants|||Number
2676072|NCT01441414|Primary|Number of Participants With Non-serious Adverse Events (AEs) in Part I (Reported in ≥2 of the Participants Overall).|"Incidence and severity of all treatment-emergent AEs (TEAEs) of both all-causality and treatment-related by preferred term (PT) categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades reported in ≥2 participants overall (CTCAE Grades 3, 4 and 5, combined) for any PT are presented. Participants who are included under all-causality TEAE PT are coded as NA if they appear for the same PT under treatment-related TEAE below.~Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week)."|4 months|The FA set was the primary population for evaluating all safety and efficacy endpoints per the treatment randomization as well as participant characteristics.|||participants|||Number
2676073|NCT01441401|Other Pre-specified|Reduction From Baseline in Epileptic Seizure Frequency|Reduction from baseline in epileptic seizure frequency was defined by the following formula, where B represented the baseline frequency of epileptic seizures during the previous 4 weeks from the treatment start date, whereas T represented the frequency of epileptic seizures during the previous 4 weeks from the end of assessment period: Reduction from baseline in epileptic seizure frequency (%) = [(T-B) / B] X 100. The median percentages were presented along with the corresponding minimum and maximum percentages.|MAX 104 weeks|The analysis population comprised of the participants in the efficacy analysis population who had assessable data of the frequency of epileptic seizures at the start of gabapentin treatment and at the end of assessment period. n=number of participants with assessable data at each post-baseline time point.|||Percentage||Full Range|Median
2676074|NCT01441401|Other Pre-specified|Responder Rate|Responder rate, which was defined as the percentage of participants whose R ratio was - 0.333 or less, was presented along with the corresponding exact 2-sided 95% CI. R ratio of - 0.333 or less corresponded to the decrease of epileptic seizure frequency by 50% or more.|MAX 104 weeks|The analysis population comprised of the participants in the efficacy analysis population who had assessable data of the frequency of epileptic seizures at the start of gabapentin treatment and at the end of assessment period. n=number of participants with assessable data at each post-baseline time point.|||Percentage of participants||95% Confidence Interval|Number
2676075|NCT01441401|Other Pre-specified|Response Ratio (R Ratio)|R Ratio was calculated by the following formula, where B represented the baseline frequency of epileptic seizures during the previous 4 weeks from the treatment start date, whereas T represented the frequency of epileptic seizures during the previous 4 weeks from the end of assessment period: R Ratio = (T - B) / (T + B). R Ratio is within the range of -1 to +1, and a negative value represents a reduction in the frequency of seizure.|MAX 104 weeks|The analysis population comprised of the participants in the efficacy analysis population who had assessable data of the frequency of epileptic seizures at the start of gabapentin treatment and at the end of assessment period. n=number of participants with assessable data at each post-baseline time point.|||Ratio||Standard Deviation|Mean
2676076|NCT01441401|Other Pre-specified|Number of Participants With Key Treatment-Related Adverse Events (Aggressive Behaviors)|Aggressive behaviors including affect lability and hostility were determined as key survey items by the sponsor (Pfizer Japan Inc.). These events were defined as the 101 preferred terms listed by pharmaceuticals and medical devices agency and classified according to MedDRA/J version 17.1. A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor.|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.|||Participants|||Number
2676077|NCT01441401|Other Pre-specified|Number of Participants With Key Treatment-Related Adverse Events (Central Nervous System Depressant Actions)|"Central nervous system depressant actions including somnolence and ataxia were determined as key survey items by the sponsor (Pfizer Japan Inc.). These events were defined according to MedDRA/J version 17.1 as the events classified in psychiatric disorders or nervous system disorders of the system organ classes, or those classified in asthenia or gait disturbance of the preferred terms. A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor."|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.|||Participants|||Number
2676078|NCT01441401|Secondary|Number of Participants Who Responded to Treatment With Gabapentin by Treatment Period|Participants who responded to the treatment with gabapentin were counted by the treatment period (non-long term [less than 1 year] or long term [1 year or more]) to assess whether the treatment period with gabapentin was a factor affecting the treatment efficacy.|MAX 104 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.|||Participants|||Number
2676096|NCT01441180|Primary|Participants With Adverse Events|Number of participants with Grade 3-4 Adverse Events During the Study Treatment Period as a measure of safety and tolerability.|24 weeks||||partipants|||Number
2676097|NCT01441102|Secondary|Number of Participants Withdrawn From the Study Therapy Due to Vision Loss or Adverse Events||Duration of the study, up to 24 months||||participants|||Number
2676080|NCT01441401|Secondary|Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure|Participants who responded to the treatment with gabapentin were counted by the baseline frequency of epileptic seizure (<=8 versus >8 episodes/per 4 weeks) to assess whether the baseline frequency of epileptic seizure was a factor affecting the treatment efficacy.|MAX 104 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.|||Participants|||Number
2676081|NCT01441401|Secondary|Number of Participants Who Responded to Treatment With Gabapentin by Baseline Severity of Epileptic Seizure|Participants who responded to the treatment with gabapentin were counted by the baseline severity of epileptic seizure (mild, moderate and severe) to assess whether the baseline severity of epileptic seizure was a factor affecting the treatment efficacy.|MAX 104 weeks|The efficacy analysis population comprised of the participants who had at least one post-baseline efficacy evaluation for the clinical efficacy and seizure frequency in the safety analysis population. Participants with diseases not eligible for the survey were excluded from the efficacy analysis population.|||Participants|||Number
2676082|NCT01441401|Secondary|Number of Participants With Risk Factors for Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Participants with treatment-related adverse events were counted by each candidate risk factor (including gender, age, and disease eligible for the survey) to assess whether these were risk factors for the treatment-related adverse events. No inferential analyses of risk factors were performed because of a small number of the events (5 events).|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once. No data displayed because outcome measure has zero total participants analyzed.||||||
2676083|NCT01441401|Secondary|Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to gabapentin was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.|||Participants|||Number
2676084|NCT01441401|Primary|Clinical Efficacy Rate|Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical efficacy over the total number of efficacy analysis population, was presented along with the corresponding exact 2-sided 95% CI. For the basis of efficacy evaluation, frequencies of epileptic seizure were recorded during the previous 4 weeks from the treatment start date, and that from the end date of assessment period. Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable.|MAX 104 weeks|The analysis population comprised of the participants in the efficacy analysis population from which those with data not assessable were excluded. n=number of participants with assessable data at each post-baseline time point.|||Percentage of participants||95% Confidence Interval|Number
2676085|NCT01441401|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to gabapentin in a participant who received gabapentin. Relatedness to gabapentin was assessed by the investigator and sponsor (Pfizer Japan Inc.).|MAX 104 weeks|The safety analysis population comprised of participants who had met the inclusion criteria and had taken gabapentin at least once.|||Participants|||Number
2676086|NCT01441245|Secondary|Dopamine Infusion During Hospitalization||in-hospital||||percentage of partecipants|||Number
2676087|NCT01441245|Primary|Evaluation of Renal Function in Terms of GFR Values at Discharge||from admission to discharge, an average of 12 days|Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant|||(ml/min·1.73 m2)||Standard Deviation|Mean
2676088|NCT01441245|Primary|Evaluation of Renal Function in Terms of Changes in GFR||from admission to discharge, an average of 12 days||||(ml/min·1.73 m2)||Standard Deviation|Mean
2676089|NCT01441245|Primary|Change in Brain Natriuretic Peptide (BNP) Levels From Admission to the Discharge||participants were followed for the duration of hospital stay, an average of 13 days|Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant.|||pg/mL||Standard Deviation|Mean
2676090|NCT01441245|Primary|Evaluation of B-type Natriuretic Peptide (BNP) Levels From Admission to the End of Treatment||from admission to discharge, an average of 12 days||||pg/ml||Standard Deviation|Mean
2676091|NCT01441245|Primary|Evaluation of Renal Function in Terms of Changes in Creatinine Levels|evaluation of renal function in terms of changes in creatinine levels during hospitalization in the two arms.|participants were followed for the duration of hospital stay, an average of 13 days|All data were analyzed with intention-to-treat. Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant.|||mg/dL||Standard Deviation|Mean
2676092|NCT01441245|Primary|Evaluation of Renal Function in Terms of Creatinine Levels at Discharge||from admission to discharge, an average of 12 days|All data were analyzed with intention-to-treat. Continuous variables are expressed as mean ± standard deviation (SD) and compared with t test for independent groups. p values <0.05 were considered significant.|||mg/dL||Standard Deviation|Mean
2676093|NCT01441245|Secondary|Length of Hospitalization in the Two Groups|percentage of participants with hospital stay > 10 days|in-hospital|Qualitative variables are expressed as percentage and compared with chi-square test . p values <0.05 were considered significant.|||percentage of partecipants|||Number
2676094|NCT01441245|Primary|Evaluation of Mean Urine Output Volume During the Infusion Period|this study aimed to evaluate the effects of continuous infusion of furosemide in comparison to twice daily regimens at similar doses with respect to changes in renal function in terms of creatinine levels and GFR, urine output and BNP levels from admission to discharge|time period ranging from 72 h to 120 h.||||mL||Standard Deviation|Mean
2676095|NCT01441180|Primary|Sustained Virologic Response|Sustained virology response at 24 weeks post treatment completion|24 weeks post treatment completion|on protocol analysis|||percentage of total participants||95% Confidence Interval|Number
2676102|NCT01441102|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 24 Months Compared to Baseline|Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).|Baseline and 24 Months||||eyes|eyes||Number
2676103|NCT01441102|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 18 Months Compared to Baseline|Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).|Baseline and 18 Months||||eyes|eyes||Number
2676104|NCT01441102|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 12 Months Compared to Baseline|Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).|Baseline and 12 Months||||eyes|eyes||Number
2676105|NCT01441102|Secondary|Number of Study Eyes Demonstrating a Decrease in the Area of Late Leakage, as Measured by Fluorescein Angiography (FA), at 6 Months Compared to Baseline|Fluorescein angiography (FA) images were obtained via a standard digital imaging system (OIS, Sacramento, CA) at baseline and at Month 6, Month 12, Month 18, and Month 24. Three retinal specialists independently graded the area of late fluorescein leakage (at approximately 10 minutes) using a region-of-interest tool in an image analysis software package (NIH ImageJ, Bethesda, MD).|Baseline and 6 Months||||eyes|eyes||Number
2676106|NCT01441102|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 24 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 24 Months||||ETDRS letters|Eyes|Standard Deviation|Mean
2676107|NCT01441102|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 18 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 18 Months||||ETDRS letters|Eyes|Standard Deviation|Mean
2676108|NCT01441102|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 12 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 12 Months||||ETDRS letters|Eyes|Standard Deviation|Mean
2676109|NCT01441102|Secondary|Change in Best-corrected Visual Acuity (BCVA) in the Study Eye at 6 Months Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 6 Months|Two participants withdrew from the study prior to the 6-month visit.|||ETDRS letters|Eyes|Standard Deviation|Mean
2676110|NCT01441102|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 24 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. Changes in OCT will be calculated using the ETDRS grid. Attention will be directed to changes in retinal thickness as measured by OCT in each of the 9 subfields of the grid.|Baseline and 24 Months||||percentage change in retinal thickness|eyes|Standard Deviation|Mean
2676111|NCT01441102|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 18 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. Changes in OCT will be calculated using the ETDRS grid. Attention will be directed to changes in retinal thickness as measured by OCT in each of the 9 subfields of the grid.|Baseline and 18 Months||||percentage change in retinal thickness|eyes|Standard Deviation|Mean
2676112|NCT01441102|Secondary|Percentage Change in Retinal Thickness in the Study Eye at 12 Months Compared to Baseline|Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. Changes in OCT will be calculated using the ETDRS grid. Attention will be directed to changes in retinal thickness as measured by OCT in each of the 9 subfields of the grid.|Baseline and 12 Months||||percentage change in retinal thickness|eyes|Standard Deviation|Mean
2676113|NCT01441102|Primary|Percentage Change in Retinal Thickness in the Study Eye at 6 Months Compared to Baseline|"Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. The participant's eye that met the study eye eligibility criteria was selected as the study eye. For cases in which both eyes met the study eye eligibility criteria, the study eye was selected according to the choice of study eye in cases of bilateral disease selection criteria outlined in the eligibility criteria. The eye not chosen as the study eye is referred to as the fellow eye."|Baseline and 6 months|Two participants withdrew from the study prior to the 6-month visit.|||percentage change in retinal thickness|Eyes|Standard Deviation|Mean
2676117|NCT01441076|Secondary|Number of Genital Ulcers by Physician Evaluation|Number of genital ulcers noted by physician evaluation|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||genital ulcers in participants||Full Range|Median
2676118|NCT01441076|Secondary|Behcets Disease Current Activity Form (BDCAF) Score|The BDCAF is a standardized assessment form in Behcet's disease to measure patient activity. Scoring is based on the history of new clinical features present over the preceding 4 weeks prior to assessment. The range of score is 0 - 12. A total lower score indicates less disease activity and a higher total score indicates more disease activity.|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
2676119|NCT01441076|Secondary|Behcet's Syndrome Activity Scale (BSAS) Score|The BSAS is a standardized assessment form in Behcet's disease. The BSAS score comprises 10 items. The total score possible is between 0-100. A total lower score indicates a less syndrome activity and a higher total score indicates more syndrome activity.|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
2676120|NCT01441076|Secondary|Behcet's Disease Related Quality of Life (BDRQOL) Assessment Score|The BDRQOL is a standardized assessment form in Behcet's disease composed of 30 items (answered true or not true) and each item is scored 0 or 1 (scoring range from 0 to 30). A total lower score indicates a better quality of life and a total higher score indicates a worse quality of life.|Baseline|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
2676121|NCT01441076|Secondary|Physician Global Score|Global visual analogue scale administered by physicians with a range of score of 0-100. Lower scores indicate least symptoms and higher scores indicate worst symptoms faced by the patient.|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
2676122|NCT01441076|Secondary|Patient Global Score|Global visual analogue scale taken by patients with a range of score of 0-100. Lower scores indicate least symptoms and higher scores indicate worst symptoms faced by the patient.|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
2676123|NCT01441076|Secondary|Number of Oral Ulcers by Physician Evaluation|Number of oral ulcers noted by physician evaluation|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||oral ulcers in participants||Full Range|Median
2676124|NCT01441076|Secondary|Number of Genital Ulcers by Physician Evaluation|Number of genital ulcers noted by physician evaluation|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||genital ulcers in participants||Full Range|Median
2676125|NCT01441076|Secondary|Behcets Disease Current Activity Form (BDCAF) Score|The BDCAF is a standardized assessment form in Behcet's disease to measure patient activity. Scoring is based on the history of new clinical features present over the preceding 4 weeks prior to assessment. The range of score is 0 - 12. A total lower score indicates less disease activity and a higher total score indicates more disease activity.|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
2676126|NCT01441076|Secondary|Behcet's Syndrome Activity Scale (BSAS) Score|The BSAS is a standardized assessment form in Behcet's disease. The BSAS score comprises 10 items. The total score possible is between 0-100. A total lower score indicates a less syndrome activity and a higher total score indicates more syndrome activity.|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
2676127|NCT01441076|Secondary|Behcet's Disease Related Quality of Life (BDRQOL) Assessment Score|The BDRQOL is a standardized assessment form in Behcet's disease composed of 30 items (answered true or not true) and each item is scored 0 or 1 (scoring range from 0 to 30). A total lower score indicates a better quality of life and a total higher score indicates a worse quality of life.|Month 6 study visit|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Units on a scale||Full Range|Median
2676128|NCT01441076|Primary|Clinical Remission From Months 3-6|Clinical remission was defined as no oral or vaginal ulcers on physical examination for 2 consecutive monthly visits from months 3-6.|Monthly study visits from months 3-6 during the trial|Analysis included all subjects who enrolled in the trial, including those who terminated the study prior to month 6 due to perceived lack of efficacy of study drug.|||Participants|||Number
2676129|NCT01441037|Primary|Number of Patients Having Attenuation of Accelerated Telomere Attrition|The primary efficacy end point was a 20% reduction in the annual rate of telomere attrition measured at 24 months. The biologic response at 24 months, was defined as a reduction in the telomere length attrition rate to 96 bp per year or less. The normal rate of telomere loss of approximately 60 bp per year. Telomere length was determined with a semiautomated, Clinical Laboratory Improvement Amendments (CLIA)-approved real-time quantitative PCR (qPCR) assay performed in triplicate and validated for human cells|24 months|The analyses included only those subjects who took Danazol|||Participants|||Count of Participants
2676130|NCT01440972|Secondary|Change in Isokinetic Knee Extensor Strength||4 weeks||||Nm/kg||Standard Error|Least Squares Mean
2676159|NCT01440881|Primary|The Examine and Measure Endothelin-1 to Measure Kidney Injury|Serial measurements of Endothelin-1 levels were measured to determine if natriuretic peptides exert their renal protective effects by preserving renal afferent arteriole flow by antagonizing the vasoconstrictive effects of Endothelin-1.|30 days from the start of infusion|randomized as outlined in the protocol|||pg/ml||Inter-Quartile Range|Median
2676131|NCT01440972|Secondary|Change in Knee Injury and Osteoarthritis Outcome Score Pain Subscale|KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life QOL. The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. KOOS is patient-administered, the format is user friendly, and takes about 10 minutes to fill out. Only the pain sub scale was used for the reported study.|4 weeks||||units on a scale||Standard Deviation|Mean
2676132|NCT01440972|Secondary|Change in Lower Limb Muscle Power by Double Leg-press at 40% 1 Repetition Maximum||4 weeks||||Watts||Standard Deviation|Mean
2676133|NCT01440972|Secondary|Change in Quadriceps Muscle Volume by Magnetic Resonance Imaging||4 weeks||||Percent change||Standard Deviation|Mean
2676134|NCT01440972|Primary|Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass||4 weeks||||kg per kg body mass||Standard Deviation|Mean
2676135|NCT01440959|Secondary|Overall Survival|Overall survival duration is calculated as time from the first treatment to the date of death. For patients who are still alive at the cut‐off date for statistical reporting, the overall survival duration will be right censored on the last known alive date.|Up to 3 years||||months||95% Confidence Interval|Median
2676136|NCT01440959|Secondary|Progression-free Survival|"Progression-free survival is defined as the time from the first treatment to the onset of progressive disease per RECIST criteria or to the date of death whichever comes first. For patients who do not experience progressive disease or death, the progression-free survival duration will be right censored on the last disease assessment date.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions"|Up to 3 years||||months||95% Confidence Interval|Median
2676137|NCT01440959|Secondary|Number of Participants With Adverse Events|Adverse events will be graded according to Common Terminology Criteria for Adverse events version 3.0, up to 3 year.|Monitoring of adverse events will be continued for at least 28 days following the last dose of study treatment, up to 3 year.||||participants|||Number
2676138|NCT01440959|Secondary|Efficacy According to the Concentrations of Circulating Growth Factors|Correlation between efficacy results, such as response, progression-free survival, and overall survival andcirculating growth factors (including vascular endothelial growth factor, fibroblast growth factor, interleukin‐8, placental growth factor, and fibroblast growth factor23), and soluble receptors (including soluble form of membrane bound vascular endothelial growth factor receptor-1 and -2).|Up to 24weeks|||||||
2676139|NCT01440959|Secondary|Efficacy According to the Primary Mutation Type|Correlation between efficacy results such as response, progression-free survival and overall survival, and primary mutation type including KIT exons 9, 11, 13, and 17 and PDGFRα exons 12 and 18.|Up to 24weeks|||||||
2676140|NCT01440959|Secondary|Overall Response Rate Using Both CT and PET Scans|PET scan will be performed at baseline and at 4 weeks of treatment. Metabolic response was defined based on the PET response criteria of the European Organization for Research and Treatment of Cancer (EORTC); a metabolic partial response (mPR) was defined as a 25% reduction in average SUVmax; metabolic stable disease (mSD) between a 25% decrease and 25% increase in average SUVmax; metabolic progressive disease (mPD) as a 25% increase in average SUVmax or the appearance of new uptake in metastatic lesions.|Up to 24 weeks||||Percentage of participants|||Number
2676141|NCT01440959|Primary|Disease Control Rate (DCR; OR + Stable Disease)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), >20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD~This was evaluated with abdominal and pelvic dynamic CT scan every 4 weeks for the initial 8 weeks, and then every 8 weeks."|Up to 24 weeks||||Percentage of participants||95% Confidence Interval|Number
2676142|NCT01440946|Secondary|Incremental Recovery (IR; One-stage aPTT Clotting Assay)|IR for FIX activity following rFIXFc dosing: IU/dL rise in plasma FIX per IU/kg drug administered. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU/dL per IU/kg||95% Confidence Interval|Geometric Mean
2676143|NCT01440946|Secondary|Mean Residence Time (MRT; One-stage aPTT Clotting Assay)|MRT: the average time for all the drug molecules to reside in the body. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||hours||95% Confidence Interval|Geometric Mean
2676144|NCT01440946|Secondary|Dose Normalized Area Under the Curve (DNAUC; One-stage aPTT Clotting Assay)|DNAUC: dose normalized area under the drug concentration-time curve (extent of unmetabolized drug in circulation). Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU*h/dL per IU/kg||95% Confidence Interval|Geometric Mean
2676145|NCT01440946|Secondary|Volume of Distribution at Steady State (Vss; One-stage aPTT Clotting Assay)|Vss: volume of distribution at steady state. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||mL/kg||95% Confidence Interval|Geometric Mean
2676146|NCT01440946|Secondary|Clearance (CL; One-stage aPTT Clotting Assay)|CL: the measure of the efficiency of the body to remove the drug and the unit is the volume of the plasma or blood cleared of drug per unit time. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||mL/h/kg||95% Confidence Interval|Geometric Mean
2676147|NCT01440946|Secondary|Terminal Half Life (t1/2; One-stage aPTT Clotting Assay)|t1/2: time required for the concentration of the drug to reach half of its original value in the body. Non-compartmental methods. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||hours||95% Confidence Interval|Geometric Mean
2676148|NCT01440946|Secondary|Maximum Plasma Activity (Cmax; One-stage Activated Partial Thromboplastin Time [aPTT] Clotting Assay)|Cmax: maximum plasma FIX activity during a dosing interval. The values for Cmax were adjusted to the nominal dose of 50 IU/kg. The 95% confidence interval on the geometric mean is based on the t-statistic back-transformed from the log scale.|Baseline (28±7 days before Day 1) Prestudy FIX Dosing: predose; 30±5 min, 3 hrs±30 min, 10±2 hrs, 24±3 hrs, 48±4 hrs postdose. Day 1 rFIXFc Dosing: predose; 30±5 min, 3 hrs ±30 min, 10±2 hrs, 24±3 hrs, 72±7 hrs, 120±12 hrs, 168±16 hrs postdose.|PK Analysis Set: all participants with adequate PK data, defined as complete and evaluable PK samples through 168 hours after rFIXFc dosing. Complete means the availability of the 168-hour sample and at least enough other samples to allow for all the PK parameters to be estimated.|||IU/dL||95% Confidence Interval|Geometric Mean
2676149|NCT01440946|Secondary|Total Dose Required for Resolution of a Bleeding Episode|The total dose required to resolve a bleeding episode per participant and per episode, based on the efficacy period. The efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. For 'Per bleeding episode' values, for each bleeding episode, the total dose is the sum of the doses (IU/kg) administered across all injections given to treat that bleeding episode. For 'Per participant' values, the total dose (IU/kg) used to resolve each bleeding episode is averaged across all bleeding episodes per participant.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; number of participants and number of episodes were determined for participants who had complete information on the dose administered to treat a bleeding episode.|||IU/kg|Bleeding Episodes|Inter-Quartile Range|Median
2676150|NCT01440946|Secondary|Number of Injections Required for Resolution of a Bleeding Episode|The number of injections required to resolve a bleeding episode per participant and per episode, based on the efficacy period. The efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. All injections given from the initial sign of a bleeding episode, until the last date/time within the bleeding episode window are counted. The resolution of a bleeding episode is defined as no sign of bleeding following injection for the bleeding episode. For 'Per participant' values, the number of injections required to resolve each bleeding episode is averaged across all bleeding episodes per participant.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; number of participants and number of episodes were determined for participants with at least 1 evaluable bleeding episode.|||injections|Bleeding Episodes|Inter-Quartile Range|Median
2676151|NCT01440946|Secondary|Number of Days From the Last Prophylaxis Injection to a Spontaneous Bleeding Episode|The number of days from the last prophylaxis injection to the onset of a new spontaneous bleeding episode, analyzed across all evaluable bleeding episodes per participant and per episode, based on the efficacy period. Evaluable bleeding episodes are those for which both a date and time are available for both the onset of the bleeding episode and the previous prophylactic injection. The efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. For 'Per participant' values, the number of days from the last prophylactic injection to a spontaneous bleeding episode is averaged across all evaluable spontaneous bleeding episodes per participant.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; number of participants and number of episodes were determined for participants with at least 1 evaluable spontaneous bleeding episode.|||days|Evaluable Spontaneous Bleeding Episodes|Inter-Quartile Range|Median
2676160|NCT01440881|Primary|The Examine and Measure Cytokines to Measure Kidney Injury|Serial measurement of serum cytokine profiles were measured with multiplex Luminex plates that enable the simultaneous measurement of 23 cytokines.|30 days from the start of infusion|randomized per protocol|||pg/ml||Inter-Quartile Range|Median
2676152|NCT01440946|Secondary|Annualized rFIXFc Consumption by Type of Injection|Annualized consumption of rFIXFc for prevention of bleeding (prophylactic), treatment of bleeding, and other rFIXFc injections. Consumption is calculated for the efficacy period. The efficacy period began with the first prophylactic dose of rFIXFc and ended with the last dose (regardless of the reason for dosing). Surgery/rehabilitation and PK evaluation periods were not included in the efficacy period. Annualized consumption = (total IU/kg of study treatment received during the efficacy period / total number of days during the efficacy period)*365.25. Participants who did not have a particular injection type are counted as having zero injections for that type.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc.|||IU/kg rFIXFc per year||Standard Deviation|Mean
2676153|NCT01440946|Secondary|Physician's Global Assessment of the Participant's Response to His rFIXFc Regimen|Investigators assessed each participant's response to his rFIXFc regimen using a 4-point scale: excellent=bleeding episodes responded to ≤ the usual number of injections or ≤ the usual dose of rFIXFc or the rate of breakthrough bleeding during prophylaxis was ≤ that usually observed; effective=most bleeding episodes responded to the same number of injections and dose, but some required more injections or higher doses, or there was a minor increase in the rate of breakthrough bleeding; partially effective=bleeding episodes most often required more injections and/or higher doses than expected, or adequate breakthrough bleeding prevention during prophylaxis required more frequent injections and/or higher doses; ineffective=routine failure to control hemostasis, or hemostatic control required additional agents. Percentages are based on the total number of responses; multiple responses per participant are counted.|Up to 50 weeks +/- 7 days|Full Analysis Set: participants who received ≥ 1 dose of rFIXFc; based on the number of responses.|||percentage of responses|responses||Number
2676154|NCT01440946|Secondary|Participant Assessment of Response to Injections to Treat a Bleeding Episode|Participant's assessment of the response (provided by the caregiver) to the first rFIXFc injection for each bleeding episode. Percentages were based on the number of bleeding episodes for which a response was provided for the first injection, using the following 4-point scale: excellent=abrupt pain relief and/or improvement in signs of bleeding within approximately 8 hours after the initial injection; good=definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an injection, but possibly requiring more than one injection after 24 to 48 hours for complete resolution; moderate=probable or slight beneficial effect within 8 hours after the initial injection and requiring more than one injection; no response=no improvement, or condition worsened, within approximately 8 hours after the initial injection.|Up to 50 weeks +/- 7 days|Full Analysis Set: participants who received at least 1 dose of rFIXFc and had ≥ 1 bleeding episode; based on the number of injections with an evaluation.|||percent of 1st injections w/ a response|Injections||Number
2676155|NCT01440946|Secondary|Annualized Joint Bleeding Rate (Spontaneous)|Annualized bleeding rate for spontaneous joint bleeding episode=(number of bleeding episodes meeting those criteria during the efficacy period/total number of days during the efficacy period)*365.25. Efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. A bleeding episode started from the first sign of bleeding and ended ≤ 72 hours after the last treatment for the bleeding episode, within which any symptoms of bleeding at the same location or injections ≤ 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken > 72 hours after the preceding 1 was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last injection.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; based on the number of participants whose efficacy period is of at least 1 day in duration.|||bleeding episodes per participant per yr||Inter-Quartile Range|Median
2676156|NCT01440946|Secondary|Annualized Bleeding Rate|Annualized bleeding rate = (number of bleeding episodes during the efficacy period / total number of days during the efficacy period)*365.25. The efficacy period begins with the first prophylactic dose of rFIXFc and ends with the last dose (for prophylaxis or a bleeding episode). Surgery/rehabilitation periods and PK evaluation periods are not included in the efficacy period. A bleeding episode started from the first sign of bleeding and ended no more than 72 hours after the last treatment for the bleeding episode, within which any symptoms of bleeding at the same location or injections less than or equal to 72 hours apart were considered the same bleeding episode. Any injection to treat the bleeding episode taken more than 72 hours after the preceding one was considered the first injection to treat a new bleeding episode at the same location. Any bleeding at a different location was considered a separate bleeding episode, regardless of time from last injection.|Up to 50 weeks +/- 7 days (efficacy period as defined in description)|Full Analysis Set: participants who received at least 1 dose of rFIXFc; based on the number of participants whose efficacy period was of at least 1 day in duration.|||bleeding episodes per participant per yr||Inter-Quartile Range|Median
2676157|NCT01440946|Primary|Occurence of Factor IX (FIX) Inhibitor Development|An inhibitor test result ≥ 0.6 Bethesda units (BU)/mL, confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. Both tests were to be performed by the central laboratory using the Nijmegen-modified Bethesda Assay. Incidences were summarized for any positive inhibitor for participants with ≥ 50 exposure days (EDs) to rFIXFc. In addition, the incidence for all participants, regardless of their EDs to rFIXFc, was also summarized. An exact 95% CI for the proportion of participants with a confirmed inhibitor was calculated using the Clopper-Pearson exact method for a binomial proportion.|Up to 50 weeks +/- 7 days, or up to 50 EDs if reached prior to Week 50|Safety Analysis Set: participants who received at least 1 dose of prestudy FIX, or at least 1 dose of rFIXFc; n=number of participants with given number of EDs who had a valid inhibitor test.|||percentage of participants||95% Confidence Interval|Number
2676158|NCT01440881|Primary|The Examine and Measure Urinary NGAL to Measure Kidney Injury|Urinary NGAL,a biomarker for kidney injury was measured.|A change in urinary NGAL 2 hours after bypass was stopped and 5 minutes after the start of spontaneous circulation was resumed.|randomized as outlined in protocol|||ng/ml||Inter-Quartile Range|Median
2676187|NCT01440569|Secondary|Change From Baseline in CD4+ Cell Count at Week 24||Baseline; Week 24|Full Analysis Set; the Missing = Excluded method was used, where participants with missing data were excluded from the analysis.|||cells/μL||Standard Deviation|Mean
2676161|NCT01440881|Primary|Measure Neutrophils to Measure Kidney Injury|0.35 mL of whole blood from each patient was applied to a microfluidics chip to isolate neutrophils. Total RNA was subsequently isolated and gene expression (for all genes listed below) was measured with an Affymetrix gene chip. Data was normalized using RMA (Robust multi-array average) and expressed as log2 expression.|30 days from the start of infusion||||log2 expression||Standard Deviation|Mean
2676162|NCT01440816|Secondary|Distant Regression Rate|Distant regression rate is defined as the percentage of participants with ≥30% regression (decrease in size) of at least one assessed distant (non-injected) lesion.|3-4 weeks after the first dose in each cycle and then every 3 months until disease progression, death or withdrawal of consent (up to 15 months)|All patients from Cohorts A and B with evaluable lesions.|||percentage of participants|||Number
2676163|NCT01440816|Secondary|Local Regression Rate|Local regression rate is defined as the percentage of participants with ≥30% regression (decrease in size) of at least one assessed local (injected) lesion.|3-4 weeks after the first dose in each cycle and then every 3 months until disease progression, death or withdrawal of consent (up to 15 months)|All patients from Cohorts A and B with evaluable lesions.|||percentage of participants|||Number
2676164|NCT01440816|Secondary|Immunologic Effects of IT pIL-12 Injection and In Vivo EP Measured By: Percentage of Participants With a Positive Fold Change (Log2) in IL-12A Messenger Ribonucleic Acid (mRNA) for Patient Pre- and Post IT pIL 12 EP|Nanostring analysis was performed to determine the expression (mRNA) of IL-12. For each study patient, the fold change (log2 transformed) in IL-12A mRNA as measured by Nanostring was determined using the pre-treatment (screening) biopsy as a reference for the post treatment biopsy. A log2 fold change >=1 is a positive result.|Pre-treatment up to Week 13|Efficacy Analysis Set, all patients from Cohort B who received any amount of the study drug (tavo) and had evaluable lesions.|||percentage of participants|||Number
2676165|NCT01440816|Secondary|Overall Survival|Overall survival is defined as the time in days from the date of first study drug administration to the date of death.|From the start of study treatment until death (up to 15 months)|Efficacy Analysis Set, all patients who received any amount of the study drug (tavo). Zero participants were analyzed for overall survival because all patients were alive at their study completion visit.||||||
2676166|NCT01440816|Secondary|Time to Progression (TTP)|TTP is defined as the number of days between the treatment initiation date (Study Day 1) and the earliest date of documented disease progression as defined by RECIST 1.1 or death that is not associated with prior disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|3-4 weeks after the first dose in each cycle and then every 3 months until disease progression, death or withdrawal of consent (up to 15 months)|Efficacy Analysis Set, all patients from Cohort B who received any amount of the study drug (tavo) and had document disease progression.|||days||95% Confidence Interval|Median
2676167|NCT01440816|Secondary|Objective Response Rate (ORR) in Injected and Non-injected (Distant) Lesions|"ORR is defined as the percentage of participants with evaluable lesions that achieved a complete response (CR) or partial response (PR) as assessed by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.~The same method was used to assess response rate for treated lesions and response rate for non-treated lesions. The best response rate for non-treated lesions was based on the number of patients who had at least one non-treated lesion."|3-4 weeks after the first dose in each cycle and then every 3 months until disease progression, death or withdrawal of consent (up to 15 months)|Efficacy Analysis Set, all patients from Cohort B who received any amount of the study drug (tavo) and had evaluable lesions.|||percentage of participants|||Number
2676168|NCT01440816|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, medical treatment or procedure and which did not necessarily have to have had a causal relationship with this treatment. An adverse event could have, therefore, been any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, medical treatment or procedure whether or not considered related to the medicinal product. An SAE was defined an any untoward medical occurrence that at any dosage resulted in one or more of the following: death, A life-threatening adverse event (real risk of dying), inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly, required intervention to prevent permanent impairment of damage.|From signing of informed consent to 8 weeks after the last dose of study treatment (up to 15 months)|Safety Analysis Set, all patients who received any amount of the study drug (tavo).|||percentage of participants|||Number
2676169|NCT01440816|Primary|Percentage of Participants Who Experienced At Least 2-Fold Increase in Expression of IL-12 Protein in the Tumor Tissue After Intratumoral (IT) pIL-12 Injections and In Vivo Electroporation|The MAGPIX assay was used to assess differential expression of hIL-12 in patient tumor tissue before and after treatment with intratumoral (IT) tavo injections and in vivo electroporation (EP). Expression of hIL-12 was used to identify patients who met the primary endpoint of a 2-fold or higher increase in expression of hIL-12 in tumors after treatment. Fold change was taken as a comparison of hIL-12 expression at Week 3:pre-treatment, Week 6:pre-treatment, Week 8:pre-treatment, or Week 13:pre-treatment over baseline (pre- treatment). The fold change was calculated as log2 (time point/baseline).|Pre-treatment up to Week 13|Efficacy Analysis Set, all patients from Cohort B who received any amount of the study drug (tavo).|||percentage of participants|||Number
2676170|NCT01440803|Primary|Change in Lumbar Spine Bone Mineral Density (LS-BMD) on Active Medication|Dual Energy X-ray Absorptiometry (DXA) will be used to measuring bone mineral density (BMD).|Baseline and 12 months|One patient in the Teriparatide (Forteo) arm was lost to follow up before the completion of the 12 month visit, therefore could not be analyzed for the primary outcome.|||percentage of change||Standard Deviation|Mean
2676171|NCT01440764|Secondary|Urine Output|Diuresis is an expected effect of furosemide. To the extent that aerosol furosemide is absorbed into the blood, diuresis is an expected 'side effect' of this treatment|Cumulative urine output 1 hour after intervention||||ml of urine||Standard Deviation|Mean
2676172|NCT01440764|Secondary|Multidimensional Dyspnea Profile|Characterization of subject's response to laboratory dyspnea model. Data are from a baseline pre-treatment test on the first drug or placebo treatment day for the subjects used in the main analysis. Subjects were asked to complete the MDP with reference to the last 30 sec of each run. To weigh subjects equally, we selected one run from each subject: the first run that terminated in a rating of overall breathing discomfort (A1) of 50 to 90% of full scale. The units of measurement are expressed as units on a 0 to 10 scale measuring intensity of a given quality, with higher values indicating greater intensity and 10 representing maximum perceived intensity.|Measured before intervention||||units on a scale||Standard Error|Mean
2676173|NCT01440764|Primary|Subject Rating of Breathing Discomfort (Dyspnea)|Change in breathing discomfort (dyspnea) rating at benchmark PETCO2 using a visual analog scale. The change in breathing discomfort is expressed as units on a 0% to 100% continuous scale, where higher values represent more dyspnea. The change is represented as the rating of breathing discomfort after the intervention minus the rating of breathing discomfort before the intervention.|The breathing discomfort ratings were taken as an average of all ratings during runs before intervention and the first two runs after intervention. The 1st and 2nd post-runs began (on average) 12 minutes and 49 minute after intervention, respectively.||||units on a scale||Standard Error|Mean
2676174|NCT01440647|Secondary|Percentage of Participants With Reintubation|Reintubation rate is a measure of the efficacy of NIPPV.|0-7 days post-extubation||||% of participants with reintubation|||Number
2676175|NCT01440647|Primary|Number of Days Being Intubated||30 days from birth||||days||Full Range|Median
2676176|NCT01440634|Primary|Effect of an Exercise Intervention on Walking Ability (Functional Outcome)|Walking distance (Six-Minute Walk test). Following a standardized protocol, individuals are instructed to walk back and forth a 100-ft hallway as far as they can in six minutes after instructions to cover as much distance as possible. A research assistant walks slightly behind each participant so as not to pace the individual. The research assistant records whether or not each person stops during the 6-minute walk. During the proposed study, members of the research team and trained lay health promoters (LHPs) will walk directly behind the individuals and give standardized instructions of encouragement at set intervals. Data will be reported on meters walked.|6 months||||meters||Standard Deviation|Mean
2676177|NCT01440595|Secondary|Number of Participants Achieving Complete Early Virologic Response (cEVR) at Week 24 in the Placebo Arm|cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 24 (i.e., after 12 weeks of placebo + 12 weeks of grazoprevir treatment). HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 24|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.||||||
2676178|NCT01440595|Secondary|Number of Participants Achieving Undetectable HCV RNA at Week 12 in the Placebo Arm|HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 12|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.||||||
2676179|NCT01440595|Secondary|Number of Participants Achieving Sustained Viral Response 24 Weeks After Completion of Therapy (SVR24)|SVR24 was defined as undetectable HCV RNA 24 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 36 for Grazoprevir treatment arms, Week 48 for Placebo arm|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.||||||
2676180|NCT01440595|Secondary|Number of Participants Achieving Sustained Viral Response 12 Weeks After Completion of Therapy (SVR12)|SVR12 was defined as undetectable HCV RNA 12 weeks after completion of study therapy. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 24 for Grazoprevir treatment arms, Week 36 for Placebo arm|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.||||||
2676181|NCT01440595|Secondary|Number of Participants Achieving Rapid Viral Response (RVR)|RVR was defined as undetectable HCV RNA at Week 4. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Week 4|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.||||||
2676182|NCT01440595|Secondary|Time to First Achievement of Undetectable HCV Ribonucleic Acid (RNA)|Time to first achievement of undetectable HCV RNA was determined by measuring HCV RNA at Treatment Days 1, 3, and 7; Treatment Weeks 2, 4, 8, 12, 16, 20, and 24; as well as Follow-up Weeks 4, 12, and 24. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v2.0 assay.|Baseline to Week 12 for Grazoprevir treatment arms, Week 24 for Placebo arm|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.||||||
2676183|NCT01440595|Primary|Number of Participants Achieving Complete Early Virologic Response (cEVR) in the Grazoprevir Treatment Arms|cEVR was defined as undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Week 12. HCV RNA was measured using the Roche COBAS® Taqman® HCV Test, v.2.0 assay.|Week 12|The Full Analysis Set (FAS) population includes all randomized participants who received at least 1 dose of study treatment. No participants completed treatment, and no analyses were conducted for this study due to early termination.||||||
2676184|NCT01440569|Secondary|Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 48||Up to 48 weeks|Full Analysis Set|||percentage of participants|||Number
2676185|NCT01440569|Secondary|Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 24||Up to 24 weeks|Full Analysis Set|||percentage of participants|||Number
2676186|NCT01440569|Secondary|Change From Baseline in CD4+ Cell Count at Week 48||Baseline; Week 48|Full Analysis Set; the Missing = Excluded method was used, where participants with missing data were excluded from the analysis.|||cells/µL||Standard Deviation|Mean
2676191|NCT01440543|Primary|Success Rate of Minimal Sedation Colonoscopy|A succesful colonoscopy using assigned technique was defined as reaching the caecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam. Any time the further insertion of the scope was not possible, the patient reported pain level > 3 using a 7-point Likert scale [7] (0 = no pain, 6 = intolerable pain) or demanded additional sedation, the endoscopist preferentially switched to the other insertion technique. Enhanced sedation was used in case the other technique had not been successful.|6 months|Statistical power was calculated for the primary endpoint. A sample size of 145 subjects per insertion arm was calculated using two-tailed α = 0,05, β = 0,05, assuming that 80% versus 60% success rate in the water (Water/CO2 and Water/Air) and gas (CO2/CO2 and Air/Air) insertion arms would have been clinically relevant.|||percentage of all participants|||Number
2676192|NCT01440543|Secondary|Patient Comfort During the Procedure and During First 24 Hours After Procedure|Comfort was assessed using a 18-point questionnaire form based on 0-6 continuous scale (0 = best, 6 = worst)- abdominal pain during, 30 minutes, 3, 12 and 24 hours after the procedure, bloating duringm 30 minutes, 3, 12 and 24 hours after the procedure, flatus during, 30 minutes, 3, 12 and 24 hours after the procedure, impact on patient´s daily activities during first 24 hours after the procedure, willingnes to repeat the colonoscopy and overall satisfaction with the procedure|six months|||||||
2676193|NCT01440543|Primary|Success Rate of Minimal Sedation Colonoscopy|Successful minimal sedation colonoscopy using assigned technique was defined as reaching the caecum without switch to another insertion method and / or without additional sedation beyond the initial administration of 2 mg of midazolam.|six months|||||||
2676194|NCT01440517|Secondary|Uptake of 99mTc-maraciclatide Agent in Diabetic Subjects With Heart Failure With Preserved Left Ventricular Fraction and Subjects With Diabetes Mellitus and Asymptomatic Diastolic Dysfunction|Due to the lack of subject enrollment, efficacy data were not analyzed.|Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.|Due to the lack of subject enrollment, efficacy data were not analyzed.||||||
2676195|NCT01440517|Primary|Evidence of Active Myocardial Angiogenesis/Remodeling|Due to the lack of subject enrollment, efficacy data were not analyzed.|Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration.|Due to the lack of subject enrollment, efficacy data were not analyzed.||||||
2676196|NCT01440387|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)|A serious adverse event was any untoward medical occurrence that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|During the entire study period (Day 0 - Day 20 after vaccination).|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2676197|NCT01440387|Secondary|Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).|An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 21-day (Days 0-20) post-vaccination period.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2676198|NCT01440387|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were chest tightness, chills, cough, fatigue, headache, joint pain at other location, muscle pain, red eyes, sore throat, swelling of the face and fever [oral temperature ≥ 38.0 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = oral temperature above 39.0°C|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2676199|NCT01440387|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling greater than 100 millimeters (mm). i.e. >100mm.|During the 4-day (Days 0-3) post-vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2676200|NCT01440387|Primary|HI Antibody Seroconversion Factors (SCFs) Against Each of the 4 Vaccine Influenza Strains.|SCFs were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.|At Day 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Fold increase||95% Confidence Interval|Geometric Mean
2676201|NCT01440387|Primary|Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.|At Day 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2676202|NCT01440387|Primary|Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains.|A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.|At Day 0 and Day 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Subjects|||Number
2676203|NCT01440387|Primary|Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains.|Antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu B/Florida/4/06 (Yamagata), FluB/Bri/60/08 (Victoria), Flu A/CAL/7/09 (H1N1) and Flu A/Victoria/210/09 (H3N2) antigens.|At Day 0 and Day 21|The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2676204|NCT01440374|Secondary|EQ-5D Utility Score Analysis|"EuroQoL Five Dimensions Questionnaire (EQ-5D) is a standardized generic preference based health related quality of life instrument. It records how one's health is today and consists of a descriptive system. The Descriptive system is Comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension on the EQ-5D involves a 3-point response scale which indicates the level of impairment (level 1 = no problem; level 2 = some or moderate problem(s) and level 3 = unable, or extreme problems). Level of problem reported in each EQ-5D dimension determines a unique health state which is converted into a weighted health state index by applying scores from EQ-5D preference weights elicited from general population samples. This generates a unique description of the subjects' health status, which is valued between 0 (representing death) and 1 (representing perfect health). Higher the score, the better the quality of life.~EQ-ED is a score."|Change from baseline, up to week 12|Part 2 Population (Intent-to-Treat population)|||Adjusted mean change from baseline||Standard Error|Mean
2676205|NCT01440374|Secondary|Functional Assessment of Cancer Therapy (FACT)|"The FACT-Th-18 is the most widely used and accepted tool evaluating health-related quality-of-life outcomes in cancer patients with chronically low platelets (where Th designates thrombocytopenia). The entire FACT-Th-18 was used in this trial, which includes the 18-item thrombocytopenia subscale used to assess the impact of symptoms, signs, and functional consequences of thrombocytopenia in MDS and AML subjects. The FACT-Th-18 is a validated and reliable instrument with known psychometric properties. FACT-ThS is an 18 item questionnaire specific to assessing the impact of symptoms, signs, and functional consequences of Thrombocytopenia. ThS score ranges from 0 to 72 with higher the score, the better the QoL. FACT G total score moves from 0 to 108 where higher the score, the better the HRQL.~FACT-Th Total Score is calculated by adding the FACT-ThS and FACT-G score. Total score ranges from 0 to 180 and again, higher the score, the better the HRQL."|Change from baseline, up to week 12|Part 2 Population (Intent-to-Treat population)|||Adjusted mean change from baseline||Standard Error|Mean
2676206|NCT01440374|Secondary|Summary of Health Outcomes|"The number of subject with medical resource utilization (MRU) data are reported in this table.~MRU included number of emergency room visits, number of home healthcare visits, number of hospitalization days, number of medication or surgery specialist visits, number of procedures inpatient, number of procedures outpatient, number of non-study radiology visits, number of non-study laboratory visits, number of nurse practitioner/physician assistance/nurse visits, number of primary care physician visits, number of telephone consultations."|week 12|Part 2 Population (Intent-to-Treat population)|||Subject with Events|||Number
2676207|NCT01440374|Secondary|Median Overall Survival||Up to 13 months|Part 2 Population (Intent-to-Treat population)|||Months||95% Confidence Interval|Median
2676208|NCT01440374|Secondary|Independent Reviewer Assessed Disease Progression||Up to week 12|Part 2 Population (Intent-to-Treat population)|||Number of subjects|||Number
2676209|NCT01440374|Secondary|Independent Reviewer-Assessed Best Response|Participants were evaluated in accordance with the modified International Working Group (Cheson, 2006). CR: Bone marrow blasts <5%, Hgb ≥11g/dL, Hematologic Improvement - Platelets (Baseline <20Gi/L: >20 Gi/L and 2x baseline; Baseline ≥20 Gi/L: ≥50 Gi/L and 2x baseline), Neutrophils ≥1.0 Gi/L, Peripheral blasts 0%. PR: Bone marrow blasts decreased by ≥50% but >5%, Peripheral blood as in CR. Marrow CR: Bone marrow blasts <5% and decrease by ≥50%, Note any Hematologic Improvements, Stable disease: Failure to achieve PR, but no evidence of progression for >8w, Cytogenetic response: Complete: disappearance of chromosomal abnormality; no new abnormalities Partial: ≥50% reduction of chromosomal abnormality.|up to week 12|Part 2 Population (Intent-to-Treat population)|||Number of subjects|||Number
2676210|NCT01440374|Secondary|Number of Participants With Maximum Bleeding Grade According to World Health Organization on Bleeding Scale|Occurrence and severity of bleeding, measured using the WHO Bleeding Scale Grade 0=no bleeding; Grade 1=petechiae; Grade 2=mild blood loss; Grade 3=gross blood loss; Grade 4=debilitating blood loss.|Weeks 5 to 12|Part 2 Population (Intent-to-Treat population)|||Number of subjects|||Number
2676211|NCT01440374|Secondary|Maximum Duration of Platelet Transfusion Independence||Weeks 5 to 12|Part 2 Population (Intent-to-Treat population)|||maximum duration of platelet transfusion||Standard Deviation|Mean
2676212|NCT01440374|Secondary|Change in Mean Platelet Count||Baseline to Week 12|Part 2 Population (Intent-to-Treat population)|||Gi/L||Standard Deviation|Mean
2676213|NCT01440374|Secondary|Hematologic Improvement|Definitions of hematologic improvement for platelets, neutrophils, and hemoglobin were based on modified International Working Group (IWG) consensus criteria.|Weeks 5 to 12|Part 2 Population (Intent-to-Treat population)|||Number of subjects|||Number
2676214|NCT01440374|Secondary|Mean Number of Platelet Transfusions||Weeks 5 to 12|Part 2 Population (Intent-to-Treat population)|||Number of platelet transfusions||Standard Deviation|Mean
2676215|NCT01440374|Secondary|Plasma Eltrombopag Pharmacokinetic Concentration-Time Data - by Visit (Part 2 Subjects)||Day 1 to week 12|Pharmacokinetic population|||ug/mL||Standard Deviation|Mean
2676216|NCT01440374|Secondary|Plasma Eltrombopag Pharmacokinetic Concentration-Time Data - by Visit (Part 1 Subjects)||Day 1 to week 8|Pharmacokinetic population: all subjects in All Subjects Population who had a PK blood sample obtained/analyzed.|||ug/mL||Standard Deviation|Mean
2676217|NCT01440374|Primary|Clinically Relevant Thrombocytopenic Events (CRTE) From Week 5 up to Week 12 During Part 2|A participant was considered to have a CRTE at a given assessment if he/she had platelet counts <10 Gi/L, or platelet transfusions, or >=Grade 3 hemorrhagic adverse events. CRTEs during Weeks 5 to 12 were compared between treatments using a generalized linear mixed model. Average of weekly proportion of subjects with CRTE during Week 5 to 12 was estimated for each treatment. Intent to Treat (ITT) Population was comprised of all randomized participants during Part 2.|From Week 5 up to Week 12 during Part 2|Part 2 Population (Intent-To-Treat (ITT) Population: all randomized subjects in part 2)|||percentages of participants||95% Confidence Interval|Mean
2676218|NCT01440374|Primary|Number of Participants With Platelet Response up to Week 8 During Part 1|A participant was considered as a responder if he/she met the following response criteria: a Baseline platelet count <20 Giga cells per liter (Gi/L) and a post-Baseline increased to >20 Gi/L and at least 2 times the Baseline value; or a Baseline platelet count >=20 Gi/L and a post-Baseline absolute platelet count increased to >=50 Gi/L and at least 2 times the Baseline value. The response criteria was evaluated at each visit. Increase in platelet count observed up to 3 days after a platelet transfusion was not considered as a platelet response. The Part 1 Population was comprised of all participants enrolled into Part 1.|From Baseline up to Week 8 during Part 1|Part 1 Population: all subjects who enrolled in Part 1.|||Participants|||Number
2676219|NCT01440322|Secondary|Back Surface Deposits (None, Very Slight)|"Back surface deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."|||Percentage of lenses|Participants||Number
2676220|NCT01440322|Secondary|Front Surface Deposits (None, Very Slight)|"Front surface deposits on the contact lens, as assessed by the investigator for each eye individually. Front surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."|||Percentage of lenses|Participants||Number
2676221|NCT01440322|Secondary|Dry Areas/Non-Wetting (None, Very Slight)|"Dry areas/non-wetting (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Dry areas/non-wetting was rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as none or very slight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."|||Percentage of lenses|Participants||Number
2676222|NCT01440322|Secondary|Lens Centration (Centered, Slight Decentration)|"Lens centration, as assessed by the investigator for each eye individually. Lens centration was rated on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as centered or slight decentration is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."|||Percentage of lenses|Participants||Number
2676223|NCT01440322|Secondary|Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)|"Lens fit, as assessed by the investigator for each eye individually. Lens fit was rated on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, -2=unacceptably tight. The combined percentage of lenses assessed as optimal, acceptably loose, or acceptably tight is reported. Lenses from both eyes contributed to the percentage."|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."|||Percentage of lenses|Participants||Number
2676224|NCT01440322|Secondary|Subjective Rating of Overall Handling|Overall handling, as rated by the participant on a 10-point scale, with 1 being difficult and 10 being easy. The participant rated both eyes together by providing one single rating.|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of participants with non-missing values at the specific time point for each arm group."|||Units on a scale||Standard Deviation|Mean
2676225|NCT01440322|Secondary|Subjective Rating of Overall Comfort|Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of participants with non-missing values at the specific time point for each arm group."|||Units on a scale||Standard Deviation|Mean
2676226|NCT01440322|Secondary|Subjective Rating of Overall Vision|Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of participants with non-missing values at the specific time point for each arm group."|||Units on a scale||Standard Deviation|Mean
2676264|NCT01440049|Primary|Percentage of Participants Who Died in SAS Population||Baseline up to Month 12|SAS population included all participants who received study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2676227|NCT01440322|Primary|Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)|Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.|Up to Month 3|"The analysis population includes all enrolled and dispensed participants who completed the study. No imputation was used for missing values. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, used as the denominator for percentage calculation."|||Percentage of eyes|Participants||Number
2676228|NCT01440283|Secondary|Quantify (in mm/cm) the Range of Target Movement During the Breathing Phase Measured by 4DMRI and 4DCT.|Obtain target tissue motion-defining data which can guide future more conformal therapeutic regimens incorporating smaller volumes of uninvolved tissue.|Baseline and approximately 2 weeks following initiation of irradiation.|All participants underwent complete surgery prior to RT, therefore, no visible tumor tissue target was available for movement measurements.||||||
2676229|NCT01440283|Secondary|Quantify the Range of Organ Movement During the Breathing Phase Measured by 4-dimensional MRI (4DMRI) and 4DCT.|Normal tissue motion-defining measurements were obtained which can guide future more conformal therapeutic regimens incorporating smaller volumes of uninvolved tissue. Participants underwent CT simulation and 4D-CT acquisition as well as real-time dynamic 4D MRI prior to the start of radiation therapy (RT), and a subsequent repeat 4D-CT was obtained approximately 2 weeks after the start of RT. The imaging position was supine with general anesthesia. Renal edges were marked in a customized graphical interface for each imaging series with the image resolution determining the minimum motion extent. Vectors of renal edge motion were quantified in the anterior-posterior (A-P), medial-lateral (M-L), and superior-inferior (S-I) dimensions. The motion extent derived from the MRI dataset was considered in defining the margins for RT treatment planning.|Baseline and approximately 2 weeks following initiation of irradiation.|Five participants did not receive all scans for motion evaluations and are excluded from the analysis. Age at scan ranges from 8 months to 9.5 years old. The median age was 3.8 years.|||mm||Standard Deviation|Mean
2676230|NCT01440283|Primary|Pattern of Local-regional Failure.|Categorical measurements of local-regional failure.|2 years after last patient enrollment|There was no local-regional failure noted (please see outcome #1), therefore, no pattern of failure could be determined.||||||
2676231|NCT01440283|Primary|Percentage of Participants Who Failed to Reach Local-regional Control|Measured from start of radiation therapy to date of local-regional failure or last follow-up.|2 years after last patient enrollment||||percentage of participants|||Number
2676232|NCT01440101|Secondary|Part A: Summary of Lymphocyte Counts Over Time||Baseline [Week 0]); 28 days post-dose; Weeks 12, 24, and 32 (follow-up)|Participants in Part A who received a dose of BG00002 and had at least 1 post-baseline assessment of lymphocytes; n=participants with assessment at timepoint.|||cells/microliter||Standard Deviation|Mean
2676233|NCT01440101|Secondary|Part A: Natalizumab Binding Saturation Of α4 Integrin Sites On Peripheral Blood Mononuclear Cells (PBMC)|Pharmacodynamic activity was assessed by measuring the degree of saturation by BG00002 of the very late antigen-4 (VLA-4, also known as α4β1 integrin) receptor on peripheral blood mononuclear cell populations. This was accomplished by staining cells with phycoerythrin-conjugated anti-human immunoglobulin G4 (IgG4) antibody (hIgG4-PE) to label the cell-bound BG00002, followed by flow cytometric detection and quantification.|Pre-dose; 4 hours post-dose; 7, 14, 21, and 28 days post-dose; Weeks 8, 12, and 16: pre-dose; Week 20: pre-dose; 4 hours post-dose; 7, 14, 21, and 28 days post-dose|Participants in Part A who received a dose of BG00002 and had at least 1 post-baseline assessment of α4-integrin saturation; n=participants with an assessment at timepoint.|||percent saturation||Standard Deviation|Mean
2676234|NCT01440101|Secondary|Part B: Number of Participants With Adverse Events (AEs)|AE=any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. Serious AE (SAE)=any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, was a life threatening event; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; or any other medically important event that, in the opinion of the Investigator, may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above. Events were categorized as related or not related; severity was categorized as mild, moderate, or severe.|Baseline (Week 0) to Week 24||||participants|||Number
2676235|NCT01440101|Secondary|Part B: Status of Serum Antibodies to Natalizumab|Persistent positivity is defined as 2 positive results separated by at least 6 to 12 weeks.|Baseline (Week 0) and Week 24|Participants with one or more post-baseline screening antibody result.|||participants|||Number
2676236|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: CL|Systemic clearance (CL) was calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration.|||mL/h||Full Range|Geometric Mean
2676237|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: Vd|Volume of distribution (Vd) was calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose; Dose 6/Week 20 pre-dose, post-dose, and 4, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint.|||L||Full Range|Geometric Mean
2676238|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: Tmax and T1/2|Time to maximum concentration (Tmax) and half-life (T1/2) were calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose; Dose 6/Week 20 pre-dose, post-dose, and 4, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint.|||hours||Full Range|Geometric Mean
2676331|NCT01439867|Secondary|Percentage of Participants With Corrected Serum Calcium Levels < 8.8 mg/dL (2.2 mmol/L) During the Study||26 weeks|The analysis included participants who received at least 1 dose of cinacalcet and had at least 1 measured serum calcium value while on cinacalcet (calcium analysis set).|||percentage of participants||90% Confidence Interval|Number
2676239|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: AUC(0-last) and (0-AUC∞)|Area under the curve to the last measurable concentration (AUC[0-last]); and area under the curve extrapolated to infinity (0-AUC∞) were calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose; Dose 6/Week 20 pre-dose, post-dose, and 4, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint.|||µg*h/mL||Full Range|Geometric Mean
2676240|NCT01440101|Secondary|Part A: Pharmacokinetic (PK) Profile of Natalizumab in Serum: Cmax|Observed maximum concentration (Cmax) was calculated using non-compartmental methods.|Dose 1/Week 0: pre-dose, post-dose and 4, 24, 48 and 96 hours post-dose; Dose 6/Week 20 pre-dose, post-dose, and 4, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint.|||µg/mL||Full Range|Geometric Mean
2676241|NCT01440101|Secondary|Part B: Concentration of Natalizumab in Serum|The concentration of BG00002 in serum was determined using an Enzyme Linked Immunosorbent Assay (ELISA).|Baseline (Week 0), Week 12, Week 24|Randomized participants who received at least 1 infusion of BG00002 and had at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of these participants with an assessment at given timepoint. Participants with values <LLQ were not counted in the n for that timepoint.|||µg/mL||Standard Deviation|Mean
2676242|NCT01440101|Secondary|Part A: Concentration of Natalizumab in Serum|The concentration of BG00002 in serum was determined using an Enzyme Linked Immunosorbent Assay (ELISA).|Week 0: pre-dose, post-dose and 2, 24, 48 and 96 hours post-dose; 7, 14, and 21 days post-dose; Weeks 4, 8, 12, and 16: pre-dose; Week 20 pre-dose, post-dose, and 2, 24, 48 and 96 hours post-dose; 7, 14, 21, and 28 days post-dose|Participants who received at least 1 infusion of BG00002 with at least 1 post-baseline assessment of BG00002 serum concentration; n = the number of participants with an assessment at given timepoint. At Weeks 8, 12, and 16, one participant had values less than the lower limit of quantitation (<LLQ) and was not counted in the n for that timepoint.|||µg/mL||Standard Deviation|Mean
2676243|NCT01440101|Secondary|Part B: Change From Baseline to Weeks 12 and 24 in the Global Assessment of Well-Being As Assessed by Participants Using a Visual Analog Scale (VAS)|The participant's self-rating of global impression of his/her well-being was assessed with a VAS. The instrument ranged from 0 to 100 (mm), where a score of 0 denoted 'poor' and a score of 100 denoted 'excellent.'|Baseline (Week 0), Week 12, Week 24|n = all participants with an assessment at baseline and given timepoint.|||units on a scale||Standard Deviation|Mean
2676244|NCT01440101|Secondary|Part B: Number of Participants Who Were Relapse Free Over 24 Weeks|Participants were categorized as relapse free=yes, relapse free=no, or relapse free=unknown. The category of relapse free=unknown includes participants who withdrew from the study and did not experience a relapse prior to withdrawal.|Baseline (Week 0) to Week 24|All participants who received study drug.|||participants|||Number
2676245|NCT01440101|Secondary|Part B: Cumulative Number Of New Or Newly Enlarging, Non-Enhancing T2-Hyperintense Lesions Over 24 Weeks||Baseline (Week 0) to Week 24|Missing new Gd+ or new or newly-enlarging, non-enhancing T2 hyperintense lesions were imputed using linear interpolation between the 2 adjacent non-missing values. For participants who discontinued the study, linear interpolation reduced to last observation carried forward (LOCF) was used for imputing any remaining missing values.|||lesions||Standard Deviation|Mean
2676246|NCT01440101|Secondary|Part B: Cumulative Number of Gd+ Lesions Over 24 Weeks||Baseline (Week 0) to Week 24|Missing new Gd+ or new or newly-enlarging, non-enhancing T2 hyperintense lesions were imputed using linear interpolation between the 2 adjacent non-missing values. For participants who discontinued the study, linear interpolation reduced to last observation carried forward (LOCF) was used for imputing any remaining missing values.|||lesions||Standard Deviation|Mean
2676247|NCT01440101|Secondary|Part B: Adjusted Annualized Relapse Rate Over 24 Weeks|The frequency of clinical exacerbations over 24 weeks was assessed using an annualized relapse rate that was calculated for each treatment group as the total number of relapses experienced in the group over the 24 weeks of treatment, divided by the total number of subject-years followed in the study. Obtained from a Poisson regression model, adjusted for the baseline relapse rate.|Week 24||||relapses per year|Participants|95% Confidence Interval|Number
2676248|NCT01440101|Secondary|Part B: Cumulative Number of New Active Lesions Over 24 Weeks||Baseline (Week 0) to Week 24|Missing new Gd+ or new or newly-enlarging, non-enhancing T2 hyperintense lesions were imputed using linear interpolation between the 2 adjacent non-missing values. For participants who discontinued the study, linear interpolation reduced to last observation carried forward (LOCF) was used for imputing any remaining missing values.|||lesions||Standard Deviation|Mean
2676249|NCT01440101|Primary|Part B: Rate of Development of New Active Lesions Over 24 Weeks|New active lesions were the sum of the gadolinium-enhancing (Gd+) lesions and any new or newly enlarging T2 hyperintense lesions that did not enhance as seen on cranial magnetic resonance imaging (MRI) scans. The rate is calculated for each participant as the ordinary least squares slope of the cumulative new active lesions over time.|Baseline (Week 0) to Week 24|Missing new Gd+ or new or newly-enlarging, non-enhancing T2 hyperintense lesions were imputed using linear interpolation between the 2 adjacent non-missing values. For participants who discontinued the study, linear interpolation reduced to last observation carried forward (LOCF) was used for imputing any remaining missing values.|||lesions per week over 24 weeks||Standard Deviation|Mean
2676250|NCT01440101|Primary|Part A: Number of Participants With Adverse Events (AEs)|AE=any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. Serious AE (SAE)=any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, was a life threatening event; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; or any other medically important event that, in the opinion of the Investigator, may have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above. Events were categorized as related or not related; severity was categorized as mild, moderate, or severe.|Baseline (Week 0) to Week 24|All participants who received study drug.|||participants|||Number
2676251|NCT01440049|Other Pre-specified|Percentage of Participants With Reason for Starting Eplerenone Treatment in FAS Population|Reasons for starting eplerenone treatment included myocardial infarction, heart failure and other conditions including severe hypertension by primary hyperaldosteronism; hypertension/coronaropathy and hypokalaemia; hypertension; left ventricular failure; not tolerated spironolactone; hypertension: gynecomastia with aldactone; pulmonary suboedema; hypertension: adrenal hyperplasia, gynecomastia with aldactone; hypertension not controlled.|Baseline|FAS population. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2676252|NCT01440049|Other Pre-specified|Percentage of Participants With Signs of Cardiac Insufficiency in FAS Population|New York Health Association (NYHA) functional classification included: Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity; fatigue, palpitation, or dyspnea with ordinary physical activity), Class III (marked limitation of physical activity; fatigue, palpitation, or dyspnea with less than ordinary physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Percentage of participants in each functional class was reported.|Baseline, Months 3, 6, 9, 12|FAS population. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.|||Percentage of participants||95% Confidence Interval|Number
2676253|NCT01440049|Other Pre-specified|Change From Baseline in Maximum Value of Kalaemia Levels in FAS Population|The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L. Change in maximum value kalaemia level was calculated by subtracting the baseline values from the maximum observed value of kalaemia levels during the study.|Baseline up to Month 12|FAS population. 'N' (number of participants analyzed)= participants evaluable for this measure. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.|||mmol/L||Standard Deviation|Mean
2676254|NCT01440049|Other Pre-specified|Maximum Kalaemia Levels in Serum in FAS Population|The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 mmol/L.|Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||mmol/L||Standard Deviation|Mean
2676255|NCT01440049|Other Pre-specified|Number of Measurements Per Month for Kalaemia Levels in FAS Population|The presence of excess potassium in the circulating blood is called hyperkalaemia. Normal potassium serum level is 3.5 to- 5.0 millimole per liter (mmol/L). Number of measurements per month for the kalaemia levels was reported.|Months 3, 6, 9, 12|FAS population. 'N' (number of participants analyzed)= participants evaluable for this measure. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.|||Measurements per month||Standard Deviation|Mean
2676256|NCT01440049|Other Pre-specified|Percentage of Participants With General Practitioner (GP) Consultation in FAS Population||Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.|||Percentage of participants||95% Confidence Interval|Number
2676257|NCT01440049|Other Pre-specified|Percentage of Participants With Other Notable Events in FAS Population|Other notable events included any clinically significant event other than death or hospitalization (example, ventricular tachycardia treated by defibrillator, imbalanced diabetes, work accident, right foot gout crisis, low back pain-oliguria, chest pain, bronchitis, renal failure, heart failure, hypotension, edema, standardization of gamma glutamyl transpeptidase (GT) after stopping lamisyl (peros) prescribed for a long term for mycosis, pain, nausea, fracture, trauma, gonarthrosis, increased urea, elevation of gamma GT etc.).|Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.|||Percentage of participants||95% Confidence Interval|Number
2676258|NCT01440049|Secondary|Percentage of Participants Who Discontinued Eplerenone Treatment in FAS Population||Baseline up to Month 12|FAS population. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2676259|NCT01440049|Secondary|Number of Participants With Concomitant Cardiovascular Treatment in SAS Population|Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.|Baseline up to Month 12|SAS population included all participants who received study medication.|||Participants|||Number
2676260|NCT01440049|Secondary|Number of Participants With Concomitant Cardiovascular Treatment in FAS Population|Concomitant cardiovascular treatment included any cardiovascular treatment other than, and in addition to, the study treatment taken at any time during the study.|Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date.|||Participants|||Number
2676261|NCT01440049|Secondary|Number of Participants With Reason for Increased or Decreased Eplerenone Dose||Baseline up to Month 12|Data were not statistically summarized and were provided in individual participant listings as per the planned analysis.||||||
2676262|NCT01440049|Primary|Number of Participants With Worsened Renal Function||Baseline up to Month 12|Data were not analyzed because the assessment of renal function was not included in the planned analysis of this study.||||||
2676263|NCT01440049|Primary|Percentage of Participants Hospitalized in FAS Population||Baseline up to Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2676265|NCT01440049|Primary|Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 12 in FAS Population|Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.|Baseline, Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2676266|NCT01440049|Primary|Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 9 in FAS Population|Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.|Baseline, Month 9|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2676267|NCT01440049|Primary|Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 6 in FAS Population|Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.|Baseline, Month 6|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2676268|NCT01440049|Primary|Percentage of Participants With Change From Baseline in Eplerenone Treatment Dosage at Month 3 in FAS Population|Change of eplerenone dosage = modified dosage (mg daily) - dosage at start of treatment (mg daily). A positive change indicated dosage increase and a negative change indicated dosage decrease.|Baseline, Month 3|FAS population. Here 'n' is signifying those participants who were evaluable for this measure at given time point for each group respectively.|||Percentage of participants||95% Confidence Interval|Number
2676269|NCT01440049|Primary|Percentage of Participants With Eplerenone Treatment Compliance at Month 12 in FAS Population|Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.|Month 12|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2676270|NCT01440049|Primary|Percentage of Participants With Eplerenone Treatment Compliance at Month 9 in FAS Population|Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.|Month 9|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2676271|NCT01440049|Primary|Percentage of Participants With Eplerenone Treatment Compliance at Month 6 in FAS Population|Participants receiving eplerenone on the basis of the approved SmPC were said to be treatment compliant.|Month 6|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2676272|NCT01440049|Primary|Percentage of Participants With Eplerenone Treatment Compliance at Month 3 in FAS Population|Participants receiving eplerenone on the basis of the approved summary of product characteristics (SmPC) were said to be treatment compliant.|Month 3|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||Percentage of participants||95% Confidence Interval|Number
2676273|NCT01440049|Primary|Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Safety Analysis Set (SAS) Population|Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.|Baseline|SAS population included all participants who received study medication. Here, 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||Percentage of EDV||Standard Deviation|Mean
2676274|NCT01440049|Primary|Systolic Ejection Fraction as a Measure of Left Ventricular Dysfunction at Inclusion for Full Analysis Set (FAS) Population|Left ventricular dysfunction, a condition in which the left ventricle of the heart exhibits a decreased functionality, was assessed based on systolic ejection fraction. Systolic ejection fraction was the fraction of the end-diastolic volume (EDV) that was ejected out of left ventricle with each contraction.|Baseline|FAS population included all participants who had been on study medication with inclusion questionnaire and at least one follow-up questionnaire completed, and excluded those participants with treatment start date occurring after the inclusion date. 'N' (number of participants analyzed)= participants evaluable for this measure.|||Percentage of EDV||Standard Deviation|Mean
2676275|NCT01439971|Secondary|Maximum Mean Increase From Baseline in Peak Thrombin Generation|The peak height is defined as the maximum thrombin concentration produced. Maximum mean increase from baseline at any time point was reported.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.|||Nanomolar (nM)||Standard Deviation|Mean
2676276|NCT01439971|Secondary|Maximum Mean Decrease From Baseline in Thrombin Generation Lag Time|The lag time is defined as the time to reach one sixth of the peak height and is a measure of the initiation phase. It is equivalent to the clotting time. Maximum mean decrease from baseline at any time point was reported.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.|||minutes||Standard Deviation|Mean
2676277|NCT01439971|Secondary|Maximum Mean Increase From Baseline in Endogenous Thrombin Potential (ETP)|ETP was evaluated using a Thrombin Generation Assay (TGA), a validated automated ex-vivo assay that measures the ability of plasma to generate thrombin. Thrombin generation curves are generated and calculated using dedicated software. ETP is the area under the thrombin generation curve and represents the total amount of generated thrombin. Maximum mean increase from baseline at any time point was reported.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.|||nanomolar*minute (nM*min)||Standard Deviation|Mean
2676278|NCT01439971|Secondary|Maximum Mean Increase From Baseline in D-Dimers|D-dimer is an indicator of fibrin formation and its subsequent lysis and is a useful biomarker representing overall activation of blood coagulation. Maximum mean increase from baseline at any time point was reported.|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.|||ng/mL||Standard Deviation|Mean
2676279|NCT01439971|Secondary|Maximum Mean Increase From Baseline in Prothrombin Fragments 1+2|Prothrombin fragment 1+2 is a coagulation factor, released when prothrombin is cleaved by activated Factor X. Elevated plasma levels of prothrombin fragment 1+2 indicate high risk of thrombosis. Maximum mean increase from baseline at any time point was reported.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.|||picomoles per liter (pmol/L)||Standard Deviation|Mean
2676280|NCT01439971|Secondary|Maximum Mean Increase From Baseline in Thrombin Anti-Thrombin (TAT) Complexes|TAT complex is a parameter of coagulation and fibrinolysis. The normal reference range of values for TAT is 1 to 4.1 mcg/L. Elevated TAT concentrations may signify predisposition to thrombosis. Maximum mean increase from baseline at any time point was reported.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug. The 'Number of Participants Analyzed' is the number of evaluable participants for this measure.|||mcg/L||Standard Deviation|Mean
2676281|NCT01439971|Secondary|Maximum Mean Decrease From Baseline in Activated Partial Thromboplastin Time (aPTT)|aPTT is a blood test that characterizes blood coagulation. Maximum mean decrease from baseline at any time point was reported.|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.|||seconds||Standard Deviation|Mean
2676282|NCT01439971|Secondary|Maximum Mean Decrease From Baseline in Prothrombin Time (PT)|PT measures how long it takes blood to clot. Maximum mean decrease from baseline at any time point was reported.|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.|||seconds||Standard Deviation|Mean
2676283|NCT01439971|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.|||hours||Full Range|Median
2676284|NCT01439971|Secondary|Clearance (CL)|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose is influenced by the fraction of the dose absorbed.|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.|||L/hr/kg||Geometric Coefficient of Variation|Geometric Mean
2676285|NCT01439971|Secondary|Volume of Distribution at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.|||L/kg||Geometric Coefficient of Variation|Geometric Mean
2676286|NCT01439971|Secondary|Mean Residence Time (MRT)|MRT is AUMCinf/AUCinf, where AUMC is the area under the first moment curve.|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.|||hours||Standard Deviation|Mean
2676287|NCT01439971|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)|AUCinf is area under the plasma concentration-time curve from time 0 extrapolated to infinite time.|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2676288|NCT01439971|Secondary|Incremental Recovery (IncRec)|IncRec is the maximum rise in plasma concentration per administered dose.|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.|||ng/mL/mcg/kg||Geometric Coefficient of Variation|Geometric Mean
2676289|NCT01439971|Secondary|Terminal Elimination Half-Life (t1/2)|t1/2 is the time measured for the plasma concentration to decrease by one half.|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.|||hour||Standard Deviation|Mean
2676290|NCT01439971|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)|Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2676291|NCT01439971|Secondary|Maximum Observed Plasma Concentration (Cmax)||Day 1 (pre-dose and 5 min, 10 min, 20 min, 30 min, 1 hr, 3 hr, 6 hr, 9 hr, and 12 hrs post-dose), Day 2 (24 hrs post-dose), Day 3 (48 hrs post-dose)|The PK parameter analysis population included enrolled and treated participants who had at least 1 of the PK parameters of interest.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2676292|NCT01439971|Primary|Number of Participants With Positive Immune Response (Anti-Drug Antibodies [ADA], PF-05280602 Inhibitor, Factor VIIa Inhibitor, Factor VII Inhibitor, and Depletion of Factor VII Activity)|Assays for the determination of a positive immune response was performed. An antibody immune response was defined as a confirmed post-treatment positive ELISA result in combination with a negative baseline sample ELISA result. Positive antibody immune responses to PF-05280602 by ELISA was evaluated for cross reactivity to NovoSeven RT and to Factor VII.|Baseline through Day 60|The immunogenicity parameter population included enrolled and treated participants with at least 1 post-treatment anti-PF-05280602 antibody (ADA), PF-05280602 inhibitor, or Factor VII activity level determination.|||participants|||Number
2676293|NCT01439971|Primary|Number of Participants With Clinically Significant Laboratory Abnormalities Meeting Stopping Criteria|Clinically significant findings for stopping rules are: hemoglobin <8 grams/deciliter (g/dL) or >20% decrease from normal baseline; WBC >20,000 cells/mm^3 or <1,500 decrease with normal baseline; platelets <100,000/mm^3 or >33% decrease from baseline; total bilirubin >1.5X ULN; AST or ALT >2.5X ULN; alkaline phosphatase >3X ULN; creatinine >1.5X baseline; BUN >31.0 mg/dL; glucose <0.6 or >1.5X reference range; uric acid > ULN; sodium >150 or <130 mEq/L; potassium >5.5 or <3.0 mEq/L; calcium >11.5 or <8.0 mg/dL; albumin <2.0 g/L; total protein <5.0 g/L; positive D-dimer at Day 15; PT prolonged by 3 seconds above baseline; ATIII < LLN and >20% decrease from baseline; troponin-T values above the reference range; fibrinogen <0.75X LLN or >25% decrease from baseline.|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.|||participants|||Number
2676294|NCT01439971|Primary|Number of Participants With Treatment-Emergent Laboratory Test Abnormalities (Normal Baseline)|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); chemistry (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, creatinine, blood urea nitrogen [BUN], glucose, uric acid, sodium, potassium, chloride, bicarbonate, calcium, albumin, total protein, creatine kinase); urinalysis (urine white blood cell [WBC], urine RBC); other (troponin T).|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.|||participants|||Number
2676295|NCT01439971|Primary|Number of Participants With Treatment-Emergent Abnormal Tissue Factor Pathway Inhibitor (TFPI) Levels by Magnitude|TFPI is a polypeptide that can regulate blood coagulation. TFPI levels of potential clinical concern are values <1X LLN and >1X ULN.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug.|||participants|||Number
2676296|NCT01439971|Primary|Number of Participants With Treatment-Emergent Abnormal Anti-Thrombin III (ATIII) Levels by Magnitude|ATIII is a protein in the blood that blocks abnormal blood clots from forming. Low levels of ATIII can cause abnormal blood clots. ATIII levels of potential clinical concern are values <1X LLN and >1X ULN.|Baseline through Day 3|The safety population included all enrolled participants who received the study drug.|||participants|||Number
2676297|NCT01439971|Primary|Number of Participants With Treatment-Emergent Abnormal Troponin-T Levels by Magnitude|Troponin-T is a cardiac marker for the evaluation of possible cardiovascular injury. Troponin-T levels of potential clinical concern are values >1.5 times the upper limit of normal (1.5X ULN) or >=2.5X ULN.|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.|||participants|||Number
2676298|NCT01439971|Primary|Number of Treatment-Emergent Hemophilia AEs by Severity|Mild severity AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function.|Baseline through Day 60|The safety population included all enrolled participants who received the study drug.|||adverse events|||Number
2676299|NCT01439971|Primary|Number of Treatment-Emergent AEs and SAEs by Severity (Except Hemophilia AEs)|AE severity were graded as mild, moderate, or severe. Mild severity AEs do not interfere with the participant's usual function. Moderate AEs interfere to some extent with the participant's usual function. Severe AEs interfere significantly with the participant's usual function.|Baseline through Day 60|The safety population included all enrolled participants who received the study drug.|||adverse events|||Number
2676300|NCT01439971|Primary|Number of Participants With Treatment-Emergent Hemophilia AEs and Withdrawals Due to Hemophilia AEs|Hemophilia AEs included spontaneous (no known contributing factor) and traumatic (known or presumed contributing factor/reason) bleeding episodes.|Baseline through Day 60|The safety population included all enrolled participants who received the study drug.|||participants|||Number
2676301|NCT01439971|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Withdrawals Due to AEs (Except Hemophilia AEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 15 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline through Day 60|The safety population included all enrolled participants who received the study drug.|||participants|||Number
2676820|NCT01436279|Secondary|Subject Discomfort Before the Abortion|Pain was subjectively described by the subjects as : None, Mild, Moderate, Severe|Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.||||participants|||Number
2676302|NCT01439971|Primary|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings|ECG findings of potential clinical concern were: PR interval greater than or equal to (>=)300 milliseconds (msec), >=25% increase from baseline for baseline values >200 msec, >=50% increase from baseline for baseline values less than or equal to (<=)200 msec; QRS complex >=140 msec or >=50% increase from baseline; QTcF interval (Fridericia's correction) >=450 msec or >=30 msec increase from baseline.|Baseline through Day 15|The safety population included all enrolled participants who received the study drug.|||participants|||Number
2676303|NCT01439971|Primary|Number of Participants With Changes Since Previous Physical Examination|Physical examinations were conducted by a physician, trained physician's assistant, or nurse practitioner. A complete physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, genitourinary, gastrointestinal, musculoskeletal, and neurological systems. The limited or abbreviated physical examination focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.|Baseline (Day 0), Day 1, Day 2, Day 3, Day 15|The safety population included all enrolled participants who received the study drug.|||participants|||Number
2676304|NCT01439971|Primary|Change From Baseline in Supine Pulse Rate|Change from baseline is the vital sign value at Day 2, Day 3, and Day 15 minus vital sign value at baseline.|Baseline, Day 2, Day 3, and Day 15|The safety population included all enrolled participants who received the study drug.|||beats per minute (bpm)||Standard Deviation|Mean
2676305|NCT01439971|Primary|Change From Baseline in Respiration Rate|Respiration rate measured as respirations per minute (resp/min).|Baseline, Day 2, Day 3, and Day 15|The safety population included all enrolled participants who received the study drug.|||resp/min||Standard Deviation|Mean
2676306|NCT01439971|Primary|Change From Baseline in Body Temperature|Body temperature was measured by mouth (oral) or ear (tympanic). A temperature greater than 38.5 degree Celsius was considered a fever.|Baseline, Day 2, Day 3, and Day 15|The safety population included all enrolled participants who received the study drug.|||degree Celcius||Standard Deviation|Mean
2676307|NCT01439971|Primary|Change From Baseline in Body Weight||Baseline, Day 2, Day 3, and Day 15|The safety population included all enrolled participants who received the study drug.|||kilograms (kg)||Standard Deviation|Mean
2676308|NCT01439971|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Supine blood pressure (BP) was measured with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg) after 5 minutes of rest. The same arm (preferably the dominant arm) was to be used throughout the study.|Baseline, Day 2, Day 3, and Day 15|The safety population included all enrolled participants who received the study drug.|||mmHg||Standard Deviation|Mean
2676309|NCT01439945|Secondary|The Intra-patient Changes of Magnesium Level From Baseline to the End of Treatment Period Between Magnesium Oxide and Placebo Arms.|"The intra-patient changes of magnesium level from baseline to the end of treatment period between magnesium oxide and placebo arms will be compared using a repeated measures model.~Serum magnesium concentrations will be performed prior to study medication usage and during the last week of blinded study use. These will be obtained in the first 150 patients. Mean change in serum magnesium concentrations will be compared between the 3 study arms to determine whether there are any apparent changes in the patients receiving placebos vs the two magnesium doses."|Baseline to week 8|All patients that started protocol treatment and had serum magnesium levels obtained at baseline and week 9 were included in this analysis.|||mg/dL||Standard Deviation|Mean
2676310|NCT01439945|Secondary|The Change of Daily Interference as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS) From Baseline to Treatment Termination.|"We will use the Hot Flash Related Daily Interference Scale (HFRDIS) (SEQ) to evaluate the specific effect of hot flashes have on various life activities such as work, social, leisure and relationships while receiving treatment. The questionnaire is 10 questions and is based on a 0=Do not interfere to 10=Completely interfere scale. The weekly score is the summation of these 10 questions and therefore ranges from 0 to 100. The total change in severity of symptoms is calculated by subtracting the week 8 score from the baseline. Therefore, values below zero indicate a worsening of symptoms and values above zero indicate an improvement and has a maximum range of -100 to 100. A gatekeeper procedure, following a fixed-sequence hypothesis testing method, was used to examine the higher dose of magnesium vs. placebo first and then the lower dose of magnesium vs. placebo, if the former was statistically significant."|Baseline to week 8|All patients that began treatment and completed the HFRDI questionnaire at baseline and week 8 were used in this analysis.|||units on a scale||Full Range|Median
2676311|NCT01439945|Secondary|The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination|"We will use the Symptom Experience Questionnaire (SEQ) to evaluate the specific impact of the study treatment on the effect hot flashes have on various life activities such as work, social, leisure and relationships. The questionnaire is 14 questions and is based on a 0=Not at all to 10=As bad as it can be scale. The change of severity of symptoms as measured by the SEQ from baseline to treatment termination will be first summarized by descriptive statistics as a percent change from baseline."|Baseline to week 8|All patients that started treatment and completed the Symptom Experience Questionnaire at baseline and Cycle 9 were included in this analysis.|||percentage change||Full Range|Median
2676312|NCT01439945|Secondary|Frequency and Maximum Grade of Adverse Events Reported Via the CTCAE 4.0 During the Treatment Period.|Frequency and severity of adverse events reported by patients in weekly Symptom Experience Questionnaire and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.|Baseline to Week 8|All patients that started protocol treatment and were evaluated for adverse events are included in this analysis.|||Participants|||Count of Participants
2676313|NCT01439945|Secondary|Weekly Frequency of Hot Flashes as Measured by the Hot Flash Diary During the Treatment Period|As part of the Hot Flash Diary, the number of hot flashes was recorded for each patient for each week. For this endpoint, the mean number of hot flashes for each group is reported. A repeated measure analysis comparing each dose level group and the Placebo is reported.|Baseline to Week 8|All patients that began protocol treatment and completed the Hot Flash Diary were included in this analysis.|||number of hot flashes||Standard Deviation|Mean
2676314|NCT01439945|Primary|The Intra-patient Changes of Weekly Hot Flash Activity From Baseline During the Treatment Period.|"The primary endpoint is the intra-patient changes of weekly hot flash activity from baseline during the treatment period. The hot flash activity will be measured by the weekly average hot flash score, which is a composite entity of both frequency and severity of hot flashes.~The hot flash severity is graded from 1 to 4 (1=mild, 2=moderate, 3=severe, and 4=very severe). The daily hot flash score is computed by multiplying the mean grade of severity by the frequency during every 24 hour period. Therefore, a score of zero is the lowest possible score and can be interpreted as having no hot flashes. The weekly hot flash score was calculated by adding all scores for the week.~The mean Hot Flash Score for each week for each group is reported and a repeated measures analysis is reported comparing each dose level group to the Placebo group."|Baseline to Week 8|All patients that began protocol treatment and completed the Hot Flash Diary were included in this analysis.|||units on a scale||Standard Deviation|Mean
2676315|NCT01439880|Secondary|Apolipoprotein B/Apolipoprotein A1 Ratio at Week 24 and Week 52||Baseline of parent study and extension study weeks 24 and 52|Participants randomized in the extension study 20110110 and with available data at each time point.|||ratio||Standard Deviation|Mean
2676316|NCT01439880|Secondary|Total Cholesterol/HDL-C Ratio at Week 24 and Week 52||Baseline of parent study and extension study weeks 24 and 52|Participants randomized in the extension study 20110110 and with available data at each time point.|||ratio||Standard Deviation|Mean
2676317|NCT01439880|Secondary|Apolipoprotein B Level at Week 24 and Week 52||Baseline of parent study and extension study weeks 24 and 52|Participants randomized in the extension study 20110110 and with available data at each time point.|||mg/dL||Standard Deviation|Mean
2676318|NCT01439880|Secondary|Non-high-density Lipoprotein Cholesterol (Non-HDL-C) Level at Week 24 and Week 52||Baseline of parent study and extension study weeks 24 and 52|Participants randomized in the extension study 20110110 and with available data at each time point.|||mg/dL||Standard Deviation|Mean
2676319|NCT01439880|Secondary|Low-density Lipoprotein Cholesterol (LDL-C) Level at Week 24 and Week 52||Baseline of parent study and extension study weeks 24 and 52|Participants randomized in study 20110110 and with available data at each time point.|||mg/dL||Standard Deviation|Mean
2676320|NCT01439880|Primary|Number of Participants With Adverse Events|Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.03, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.|52 weeks in the SOC-controlled period and up to 4 years in the All-IP period; actual median duration of treatment in the All-IP period was 46.9 months.|All randomized participants (year 1) and randomized participants on study and who received at least 1 dose of evolocumab in the all-IP period (years 2-5).|||Participants|||Count of Participants
2676321|NCT01439867|Secondary|Dose- and Weight-Normalized Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUClast) for Cinacalcet||Week 12|The Pharmacokinetic/ Pharmacodynamic (PK/PD) analysis set includes all participants who received at least one dose of study drug and had at least one evaluable PK parameter.|||hr*ng/mL/(mgkg)||Standard Deviation|Mean
2676322|NCT01439867|Secondary|Dose- and Weight-Normalized Maximum Plasma Concentration (Cmax) of Cinacalcet||Week 12|The Pharmacokinetic/ Pharmacodynamic (PK/PD) analysis set includes all participants who received at least one dose of study drug and had at least one evaluable PK parameter.|||ng/mL/(mgkg)||Standard Deviation|Mean
2676323|NCT01439867|Secondary|Percentage of Participants Who Achieved iPTH Values < 300 pg/mL During the Study|A participant was considered to have achieved iPTH < 300 pg/mL (31.8 pmol/L) during the study if any post-baseline iPTH value was < 300 pg/mL.|26 weeks|The analysis included all enrolled subjects with at least 1 post-baseline assessment (full analysis set).|||percentage of participants||90% Confidence Interval|Number
2676324|NCT01439867|Secondary|Percentage of Participants Who Achieved iPTH Values Between 200 and 300 pg/mL at Any Two Consecutive Measurements|A participant was considered to have achieved iPTH between 200 and 300 pg/mL (21.2 and 31.8 pmol/L) at any 2 consecutive measurements if any two consecutive post-baseline iPTH values were within the range regardless if there was a missing value in between. The analysis included all enrolled subjects with at least 1 post-baseline assessment.|26 weeks|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set).|||percentage of participants||90% Confidence Interval|Number
2676325|NCT01439867|Secondary|Percentage of Participants Who Achieved ≥ 30% Reduction in iPTH From Baseline During the Study|A participant was considered to have achieved ≥ 30% reduction in iPTH if the percent change of any post-baseline iPTH value was ≤ -30% from baseline.|26 weeks|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set).|||percentage of participants||90% Confidence Interval|Number
2676326|NCT01439867|Secondary|Percentage of Participants Who Achieved > 30% Reduction in iPTH From Baseline at Any Two Consecutive Measurements|A participant was considered to have achieved > 30% reduction in iPTH from baseline at any 2 consecutive measurements if percent change of any two consecutive post-baseline iPTH values were < -30% regardless if there was a missing value in between.|26 weeks|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set).|||percentage of participants||90% Confidence Interval|Number
2676327|NCT01439867|Secondary|Percent Change From Baseline in Calcium Phosphorus Product (Ca x P)||Baseline and weeks 3, 7, 11, 15, 19, 22, and 24|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.|||percent change||Standard Deviation|Mean
2676328|NCT01439867|Secondary|Percent Change From Baseline in Serum Phosphorous||Baseline and weeks 3, 7, 11, 15, 19, 22, and 24|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.|||percent change||Standard Deviation|Mean
2676329|NCT01439867|Secondary|Percent Change From Baseline in Corrected Serum Calcium||Baseline and weeks 3, 7, 11, 15, 19, 22, and 24|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.|||percent change||Standard Deviation|Mean
2676330|NCT01439867|Secondary|Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)||Baseline and weeks 3, 7, 11, 15, 19, 22, and 24|The analysis included all enrolled participants with at least 1 post-baseline assessment (full analysis set) and with available data at each time point.|||percent change||Standard Deviation|Mean
2676332|NCT01439867|Primary|Percentage of Participants With Hypocalcemia|Hypocalcemia was defined as corrected serum calcium levels < 9.0 mg/dL (2.25 mmol/L) for participants aged 28 days to < 2 years, and < 8.4 mg/dL (2.1 mmol/L) for participants aged ≥ 2 years to < 6 years at any time during the study.|26 weeks|The analysis included participants who received at least 1 dose of cinacalcet and had at least 1 measured serum calcium value while on cinacalcet (calcium analysis set).|||percentage of participants||90% Confidence Interval|Number
2676333|NCT01439854|Secondary|Change in Mitochondrial Function|The change in mitochondrial function/gene expression at two weeks compared to baseline. This was measured by energy expenditure.|baseline, two weeks||||cal/min.kg||Standard Deviation|Mean
2676334|NCT01439854|Primary|Change in Insulin Sensitivity|The change in insulin sensitivity and total glucose disposal measured at two weeks with the insulin clamp compared to baseline. This is measured using TGD (whole body tissue glucose disposal)/SSPI (steady state plasma insulin concentration) ratio|baseline, two weeks||||mg/kg.min per µU/ml||Standard Deviation|Mean
2676335|NCT01439724|Secondary|Oral Mucositis Survival Free, Pain, Opioid Treatment, Hospitalization, Treatment Interruption, Treatment Delay, Patient Weight Loss, Nasogastric Tube or of a Gastrostomy.|Oral mucositis survival free, pain, opioid treatment, hospitalization, treatment interruption, treatment delay, patient weight loss, nasogastric tube or of a gastrostomy.The oral cavities of all patients were evaluated, from the first day to the last day of treatment.|7 weeks|||||||
2676336|NCT01439724|Primary|Incidence and / or Severity of Oral Mucositis|The oral cavities of all patients were evaluated daily, from the first day until the last day of treatment. We used the scales of mucositis of the World Health Organization (WHO) and the Oral Mucositis Assessment Scale (OMAS) and a visual analogue scale (VAS) for pain assessment.|7 weeks|Data related to the primary endpoint were handled in a per protocol treatment analysis.|||Grade 3-4 oral mucositis|||Number
2676337|NCT01439711|Secondary|Mean Total MRI Tumor Diameter Change From Baseline to Month 6|To ascertain the change in maximum tumor diameter from baseline to 6 months (D6) the same methods as in Primary outcome #2 will be used but on diameter instead of volume. For patients with more than one lesion longest diameter measurement, the sum of all lesion longest diameter measurements was calculated.|6 months||||millimeters||95% Confidence Interval|Mean
2676338|NCT01439711|Secondary|Mean Total MRI Tumor Diameter Change From Baseline to Month 6|Mean total MRI tumor diameter change from baseline to month 6: To ascertain the change in maximum tumor diameter from baseline to 6 months (D6) the same methods as in Primary Outcome #2 will be used but on diameter instead of volume.|6 months||||millimeters||95% Confidence Interval|Mean
2676339|NCT01439711|Secondary|Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0|The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event at least possibly related to the study treatment are reported below.|Up to 6 months post surgery|Patients who had completed the study and had an Adverse Event Form submitted were included in this analysis.|||Participants|||Count of Participants
2676340|NCT01439711|Secondary|Size of Margins (Smallest) at Surgery||3-months and 6-months|||||||
2676341|NCT01439711|Secondary|Presence of Invasive Cancer at Surgery||3-months and 6-months|||||||
2676342|NCT01439711|Secondary|Extent of Residual DCIS Post Surgery||Up to 6 months post-surgery|||||||
2676343|NCT01439711|Secondary|Number of Re-excisions Required to Obtain Clear Margins||3-months and 6-months|||||||
2676344|NCT01439711|Secondary|Type of Primary Surgery (Mastectomy or Lumpectomy)|Rate of Mastectomy will be estimated as the number of mastectomies divided by the number of surgeries. A 95% confidence interval will be constructed using exact binomial methods. Rate of Lumpectomy will be estimated as the number of lumpectomies divided by the number of surgeries. A 95% confidence interval will be constructed using exact binomial methods.|up to 6 months|Patients who underwent surgery were included in this analysis.|||percentage of surgeries||95% Confidence Interval|Number
2676345|NCT01439711|Secondary|Change in Maximum Diameter at 6-months Based on Mammographic Measurement (MD6)|Change in maximum diameter at 6-months based on mammographic measurement (MD6) will be estimated using the methods in Primary Outcome #1, but using the mammographic measurements instead.|6-months|Patients who completed a mammogram at both time points (baseline and month 6) with measurements available were included in this analysis.|||millimeters||95% Confidence Interval|Mean
2676346|NCT01439711|Secondary|Mean Total MRI Tumor Diameter Change From Baseline to Month 3|To ascertain the change in maximum tumor diameter from baseline to 3 months (D3) the same methods as in Primary outcome #1 will be used but on diameter instead of volume. For patients with more than one lesion longest diameter measurement, the sum of all lesion longest diameter measurements was calculated.|3-months||||millimeters||95% Confidence Interval|Mean
2676347|NCT01439711|Primary|Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 6 (V6)|Mean total MRI FTV change from baseline to month 6 (V6): For patients with more than one measureable lesion on the MRI, the sum over all measureable lesions on the MRI was calculated at each time point. V6 was calculated by subtracting the total MRI FTV measured at 6 months from the total MRI FTV measured at baseline. For V6 the raw change in the volume will be calculated for each patient and a mean and 95% confidence interval will be constructed using two-sided t-tests.|up to 6 months from start of treatment||||cubic centimeters||95% Confidence Interval|Mean
2676348|NCT01439711|Primary|Mean Total MRI Functional Tumor Volume (FTV) Change From Baseline to Month 3 (V3)|Mean total MRI FTV change from baseline to month 3 (V3): For patients with more than one measureable lesion on the MRI, the sum over all measureable lesions on the MRI was calculated at each time point. V3 was calculated by subtracting the total MRI FTV measured (i.e. the sum over all lesions present with MRI FTV measurements) at 3 months from the total MRI FTV measured at baseline. For V3 the raw change in the volume will be calculated for each patient and a mean and 95% confidence interval will be constructed using two-sided t-tests.|up to 3 months from start of treatment||||cubic centimeters||95% Confidence Interval|Mean
2676349|NCT01439672|Primary|Insulin Sensitivity|Measure insulin sensitivity following a mixed meal across admissions. Insulin sensitivity was measured based on the minimal model of glucose kinetics using plasma glucose and insulin obtained frequently (approximately every 5-15 minutes) in response to mixed meal challenge.|24 hours||||1/min per uU/mL||Standard Deviation|Mean
2676350|NCT01439633|Primary|Number of Subjects in Which the Targeted Locations Identified Through OFDI Imaging Correlates With the Biopsies.|Determination of the feasibility to mark targeted pathologic locations identified through OFDI imaging using superficial cautery marks.Verification by endoscopy and utilization of the marks for biopsy guidance.Images will be analyzed and compared to biopsies of the correlated marked tissue.|day 1, during diagnostic procedure||||Participants|||Count of Participants
2676351|NCT01439620|Primary|Feasibility of Imaging the Bile Duct With the OFDI Probe|The number of subjects in which the performed OFDI imaging visualizes common bile duct and common hepatic duct strictures.|day 1, during diagnostic procedure|Seven subjects were enrolled and imaged in this study|||Participants|||Count of Participants
2676352|NCT01439594|Primary|Feasibility of OFDI Imaging as Determined by Number of Successful Imaging Sessions|Images will be taken and compared to standard of care biopsy to assess the success and degree of injury associated with radiofrequency ablation techniques. A successful imaging session is defined as any session where the OFDI device was able to take and produce discernible and clear data that is comparable to corresponding biopsy histopathology. It is considered unsuccessful if we were unable to produce OFDI data and/or attain a corresponding biopsy.|During the OFDI imaging session (about 5 minutes)|A total of 17 Participants took place in this study.|||Imaging sessions|Completed Imaging sessions||Number
2676353|NCT01439581|Primary|Pressure Mapping Reducing Hospital Acquired Pressure Ulcers|Comparing number of pressure ulcers when using pressure mapping compared to when not.|Time admitted in the Medical Intensive Care Unit||||Participants|||Count of Participants
2676354|NCT01439568|Secondary|Duration of Overall Response (DOR)|DOR was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|Date of Response to Date of Progressive Disease (Up To 59 Months)|All participants who received at least one dose of study drug. One participant was excluded from analysis due to protocol violation. The number of participants censored were LY2510924 + Carboplatin + Etoposide=47 and Carboplatin + Etoposide=42.|||Months||95% Confidence Interval|Median
2676355|NCT01439568|Secondary|Overall Survival (OS)|Overall survival (OS) is defined as the time from the randomization to the date of death from any cause. For participants who are still alive as of the data cutoff date, OS time will be censored on the date of the participant's last contact (last contact for participants in postdiscontinuation is last known alive date in mortality status).|Randomization to Date of Death from Any Cause (Up To 59 Months)|All participants who received at least one dose of study drug. One participant was excluded from analysis due to protocol violation. The numbers of participants censored were LY2510924 + Carboplatin + Etoposide= 4 and Carboplatin + Etoposide=3.|||Months||95% Confidence Interval|Median
2676356|NCT01439568|Secondary|Number of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])|ORR is defined as the number of participants with a best response of CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.Tumor marker results must have normalized. PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression.|Baseline to Date of Tumor Response or Measured Progressive Disease or Date of Death from any Cause (Up to 59 Months)|All participants who received at least one dose of study drug. One participant was excluded from analysis due to protocol violation.|||Participants|||Count of Participants
2676357|NCT01439568|Primary|Progression Free Survival (PFS)|PFS is defined as the time from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For participants who are still alive at the time of analysis and without evidence of tumor progression, PFS will be censored at the date of the most recent objective progression-free observation. For participants who receive subsequent anticancer therapy (except PCI) prior to objective disease progression or death, PFS will be censored at the date of the last objective progression-free observation prior to the date of subsequent therapy.|Randomization to Measured Progressive Disease or Date of Death from Any Cause (Up To 59 Months)|All participants who received at least one dose of study drug. One participant was excluded from analysis due to protocol violation.The number of participants censored were LY2510924 + Carboplatin + Etoposide=13 and Carboplatin + Etoposide=7.|||Months||95% Confidence Interval|Median
2676358|NCT01439555|Secondary|Clinical Interview Based Impression of Change + Caregiver Input (CIBIC Plus)|The Clinical Interview Based Impression of Change + Caregiver Input (CIBIC Plus) is a semi-structured instrument to examine four major areas of patient function: General, Cognitive, Behavioral and Activities of Daily Living. It is scored from 1 to 7. A score of 1 indicates marked improvement, 4 indicates no change and 7 indicates marked worsening.|Baseline to 4 weeks, 8 weeks and 16 weeks post-baseline||||score on a scale||Standard Deviation|Mean
2676359|NCT01439555|Secondary|Alzheimer's Disease Assessment Scale: Cognitive and Modified Version (ADAS-COG)|Mean Alzheimer's Disease Assessment Scale: Cognitive Subscale (ADAS-COG) score at baseline and at 16 weeks post-enrollment. The ADAS-COG consists of 11 tasks measuring disturbances of memory, language, praxis, attention and other cognitive abilities. Total scores range from 0 to 70, with higher scores (18 and above) indicating greater cognitive impairment.|Baseline to 16 weeks post-baseline||||score on a scale||Standard Deviation|Mean
2676360|NCT01439555|Secondary|Clinical Dementia Rating Scale (CDR)|This outcome measures Clinical Dementia Rating Scale (CDR) scores at baseline (enrollment) and 16 weeks post-enrollment. The Clinical Dementia Rating Scale is scored with a composite scale of 0 to 3, with higher scores indicating lower functional status and lower scores indicating better functional status.|Baseline to 16 weeks post-baseline||||score on a scale||Standard Deviation|Mean
2676361|NCT01439555|Secondary|Cognitive Assessment Screening Test (CAST)|This outcome measured the change in average Cognitive Assessment Screening Test (CAST) scores for the participant group. The CAST is scored from 0 to 40. A higher score indicates better performance, and a lower score indicates worse performance. The participants were given the CAST at baseline, 4 weeks, 8 weeks and 16 weeks post-baseline. The outcome reports on the averaged change for the averaged CAST scores from baseline to 16 weeks.|Baseline to 16 weeks post-baseline||||score on a scale||Standard Deviation|Mean
2676362|NCT01439555|Secondary|Mini Mental State Examination (MMSE) Scores|Change in mental state as reflected by changes to mean Mini Mental State Examination (MMSE) score as measured 4 weeks, 8 weeks and 16 weeks post-baseline. The MMSE uses a 30 point questionnaire to measure cognitive impairment. The MMSE is scored from 0 to 30,with a score equal to or greater than 24 points indicating normal cognition, a score of 19-23 points indicating mild cognitive impairment, 10-18 points indicating moderate impairment and a score equal to or below 9 indicating severe impairment.|Baseline to 4 weeks, 8 weeks and 16 weeks post-baseline|Patients were sequentially treated with the HMC-CoA reductase synthesis inhibitor simvastatin (weeks 0-16); L-Arginine (weeks 4-16); and tetrahydrobiopterin (weeks 8-16). The investigators assessed cognitive function with a psychometric battery including the MMSE at each time point.|||score on a scale||Standard Deviation|Mean
2676363|NCT01439555|Primary|Change in Cerebral Blood Flow as Measured by Arterial Spin Labeling During Magnetic Resonance Imaging (MRI)|Data not available as files corrupted and could not be analyzed|Baseline to week 16|Data files corrupted, analysis not possible||||||
2676364|NCT01439555|Primary|Mean Change in Cerebral Blood Flow as Measured by Magnetic Resonance Imaging (MRI)|Measurement of changes to cerebral blood flow (ml/110g/min) in regions of interest as measured using Magnetic Resonance Imaging (MRI)|Baseline to 16 weeks|Data for 6 participants available. Data file for remaining participants corrupted and could not be retrieved for analysis/reporting.|||ml/110g/min||Standard Deviation|Mean
2676365|NCT01439373|Secondary|Mean Pre-dose Concentration and Concentration at 2 to 4 h Post-dose of GSK2336805 at Days 7, 14, 21, and 28|The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters.|0 (pre-dose), 0 to 2 h, > 2 h up to 4 h, > 4 h up to 6 h, or > 6 h up to 10 h on Days 7, 14, 21 and 28|Sparse PK population included all participant who received GSK2336805, underwent sparse PK sampling during part 2 of the study, and provide at least one evaluable GSK2336805 PK concentration. Only those participants available at the specified time points were analyzed.|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2676366|NCT01439373|Secondary|Mean Apparent Clearance (CL/F) of GSK2336805|The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters|0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 1)|Intensive PK Population.|||L/h||Geometric Coefficient of Variation|Geometric Mean
2676367|NCT01439373|Secondary|Mean Maximum Plasma Concentration of GSK2336805 (Cmax) and Concentration at 24 h (C24) at Day 1|The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by non-compartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters.|0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 1)|Intensive PK Population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2676368|NCT01439373|Secondary|Median Time of Maximal Plasma Concentration (Tmax) of GSK2336805 and Lag Time Before First Observation of Quantifiable Concentration (Tlag) at Day 1|The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were BLQ before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters|0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 2)|Intensive PK Population.|||h||Full Range|Median
2676369|NCT01439373|Secondary|Mean Area Under the Concentration-time Curve (AUC[0-24]), AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) of GSK2336805, at Day 1|AUC values were determined using the linear-up, log-down trapezoidal rule. The individual plasma concentration and actual time data was used to derive the PK parameters of GSK2336805 on Day 1 by noncompartmental PK analyses. For the calculation of PK parameters all plasma concentrations that were below quantification limit (BLQ) before the first measurable concentration were set to zero. The BLQ values that occur at the end of the profile after the last quantifiable concentration were set to missing. Actual sampling times, rather than scheduled sampling times, were used in all computations of PK parameters.|0.0 (pre-dose) and 1, 2, 4, 6, 8, and 24 h post-dose (morning of Day 2)|Intensive Pharmacokinetic (PK) Population comprised of all participants who received GSK2336805, undergo intensive PK sampling during part 1 (Day 1) of the study, and provide evaluable GSK2336805 PK parameters.|||Nanogram (ng)*h/mL||Geometric Coefficient of Variation|Geometric Mean
2676408|NCT01439282|Secondary|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)||Day 1 through 30 days after last dose of study drugs (approximately up to 3 years)|The safety analysis set was all participants who received at least 1 dose of study treatments and had at least 1 post treatment safety assessment.|||participants|||Number
2676370|NCT01439373|Secondary|Median Serum Alanine Aminotransferase at Baseline, Day 7, 14, 21, 28 and 42|Blood samples were collected at Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42 for determination of serum alanine aminotransferase levels.|Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42|Safety Population. Only those participants available at the specified time points were analyzed.|||U/L||Full Range|Median
2676371|NCT01439373|Secondary|Change From Baseline in Serum Alanine Aminotransferase Levels|Blood samples were collected at Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42 for determination of serum alanine aminotransferase levels. Baseline was defined as the last non-missing assessment on or before the first dose of study drug. Change from Baseline was computed as value at post Baseline specified time point minus Baseline value.|Baseline (Day 1, Pre-dose), Day 7, 14, 21, 28 and 42|Safety population. Only those participants available at the specified time points were analyzed.|||Units per litre (U/L)||Standard Deviation|Mean
2676372|NCT01439373|Secondary|Mean Change From Baseline in Serum HCV RNA Levels at Day 2 and Day 28|Blood samples for determination of HCV RNA levels were collected from screening, immediately prior to and 1, 2, 4, 6, and 8 h after the first dose in Part 1 (Day 1), during Part 2 on Days 2 (24 h after the Day 1 dose), 7, 14, 21, and 28, and at the post-treatment follow-up visit on Day 42. All viral load samples, with the exception of the one taken during the screening visit, were taken in duplicate. The actual time and date of each sample collection will be recorded. Measurement of HCV viral load was analyzed by the central laboratory using the COBAS AmpliPrep/COBAS TaqMan HCV test.|Baseline (Day 1, Pre -dose ) and Day 2 (24 h, post-dose), Day 28|Intent-to-Treat Exposed population. Only those participants available at the specified time points were analyzed.|||Log IU/mL||Standard Deviation|Mean
2676373|NCT01439373|Secondary|Mean Serum HCV RNA Levels at Baseline (Day 1), Day 2 and Day 28|Blood samples for determination of HCV RNA levels were collected from screening, immediately prior to and 1, 2, 4, 6, and 8 h after the first dose in Part 1 (Day 1), during Part 2 on Days 2 (24 h after the Day 1 dose), 7, 14, 21, and 28, and at the post-treatment follow-up visit on Day 42. All viral load samples, with the exception of the one taken during the screening visit, were taken in duplicate. The actual time and date of each sample collection will be recorded. Measurement of HCV viral load was analyzed by the central laboratory using the COBAS AmpliPrep/COBAS TaqMan HCV test.|Baseline (Day 1, pre-dose), Day 2 (24 h, Post-dose) and Day 28|Intent-to-Treat Exposed population. Only those participants available at the specified time points were analyzed.|||Log IU/mL||Standard Deviation|Mean
2676374|NCT01439373|Secondary|Number of Participants With Vital Signs of Potential Clinical Concern|The potential clinical importance ranges (low and high) of the vital sign parameters were for systolic blood pressure (<85 and >160 millimeter of mercury [mmHg]), diastolic blood pressure (<45 and >100 mmHg) and heart rate (<40 and >110 beats per minute). Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important vital parameter findings at any visit were reported.|Up to 42 days|Safety population.|||Participants|||Count of Participants
2676375|NCT01439373|Secondary|Number of Participants With Shifts in Urinalysis Parameters From Normal at Baseline to Abnormal|The urinalysis parameters analyzed were Leukocyte esterase, bilirubin, occult blood, glucose, ketones, nitrite, pH, specific gravity and dipstick assessments. Only those parameters for which at least one value of potential clinical importance was reported are summarized. The number of participants with potential clinical important urinalysis findings at specified visit were reported. Visits where no abnormal values were observed not reported.|Day 14, 28, Follow-up (Day 42)|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2676376|NCT01439373|Secondary|Number of Participants With Shift From Baseline to Worst Post Baseline Toxicity Grade for Serum Chemistry Parameters for Day 1 to Day 28|Abnormalities were graded according to the modified DAIDS version 1.0. Shift from Baseline to worst post Baseline toxicity grade were presented for Day 1 to Day 28. The toxicity Grades were, Grade 1: mild (no or minimal interference with usual social & functional activities); Grade 2: moderate (greater than minimal interference with usual social and functional activities); Grade 3: severe (inability to perform usual social and functional activities); Grade 4: potentially life threatening (inability to perform basic self-care functions or Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death). Clinical chemistry parameters were alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, creatine phosphokinase, total CO2, chloride, creatinine, glucose, sodium, phosphate, potassium, total albumin, total bilirubin, and direct bilirubin. Only participants with change in toxicity grades are reported.|Baseline (Day 1) and 28|Safety population.|||Participants|||Count of Participants
2676377|NCT01439373|Secondary|Number of Participants With Shift From Baseline to Worst Post Baseline Toxicity Grade Hematology Parameters for Day 1 to Day 28|Laboratory abnormalities were graded according to the modified division of AIDS ( DAIDS）version 1.0. Shift from Baseline to worst post baseline toxicity grade (where applicable) were presented for Day 1 to Day 28. The toxicity Grades were, Grade 1: mild (no or minimal interference with usual social & functional activities); Grade 2: moderate (greater than minimal interference with usual social and functional activities); Grade 3: severe (inability to perform usual social and functional activities); Grade 4: potentially life threatening (inability to perform basic self-care functions or Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death). Hematology parameters were red blood cell, hemoglobin, hematocrit, platelet white blood cell count with differential leukocyte count, mean corpuscular volume, prothrombin time and international normalized ratio.|Baseline (Day 1) to Day 28|Safety population.|||Participants|||Count of Participants
2676378|NCT01439373|Primary|Change From Baseline in QTcF Interval at Day 2 and 28|Single 12-lead electrocardiogram (ECG) was obtained. The standard ECG criteria of potential clinical importance were 1) absolute QTc Interval, > 450 milliseconds (msec), 2) absolute PR Interval, <110 msec, 3) absolute QRS Interval, < 75 msec and 4) increase from baseline in QTc > 60 msec. QTc Interval was calculated using Frederica correction formula: QTcF = QT / (RR)^1/3. Change from Baseline was calculated by subtracting the Baseline assessment value from post Baseline visit value. Baseline was defined as the last non-missing assessment on or before the first dose of study drug. The change from Baseline in QTc Interval at Day 2 and 28 were reported.|Baseline (Day 1, Pre-dose ), Day 2 and Day 28|Safety population.|||msec||Standard Deviation|Mean
2676449|NCT01439009|Primary|Third Heart Sound|Of the subjects who had third heart sound at baseline, the number of subjects whose symptom was resolved at completion of treatment. Statistical comparison was not done.|Day15||||participants|||Number
2676379|NCT01439373|Primary|Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Event (SAE) During Treatment Period|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.|Up to Day 28|Safety population was consisted of all participants who received at least 1 dose of study medication (GSK2336805 or matching placebo).|||Participants|||Count of Participants
2676380|NCT01439373|Primary|Change From Baseline in HCV Viral Load During 24 Hour (h) Following a Single Dose of GSK2336805 on the Log 10 Scale|Blood samples for determination of HCV RNA levels were collected at immediately prior to and 1, 2, 4, 6, and 8 and 24 h after the first dose in Part 1 (Day 1). Measurement of HCV viral load was analyzed by the central laboratory using the COBAS AmpliPrep/COBAS TaqMan HCV test. Baseline was defined as the last non-missing assessment on or before the first dose of study drug. Change from Baseline was computed as value at post Baseline specified time point minus Baseline value. Virus RNA levels reported as <43 are undetectable levels. If the result for HCV RNA (IU/ML) was <43, then change from Baseline was calculated using 42, and the change from Baseline on the log scale was calculated using log (42).|Day 1 (Baseline [Pre-dose], 1, 2, 4, 6, and 8 and 24 h)|Intent-to-Treat Exposed population.|||Log IU/mL||Standard Deviation|Mean
2676381|NCT01439373|Primary|Number of Participants With HCV Genotype 1 With Virologic Response|Serum for determination of HCV genotype was collected at the screening visit. Genotype was determined by the VERSANT HCV genotype 2.0 Assay (LiPA). Number of participants with HCV genotype 1 were reported.|Day 7, 14 and 21|Intent-to-Treat Exposed population.|||Participants|||Count of Participants
2676382|NCT01439373|Primary|Probability of Participants With HCV Genotype 1 Achieving RVR at Day 28, Primary and Supportive Analyses|The primary comparison of interest was performed using a Bayesian probability model. Probability of achieving undetectable HCV RNA distribution analyzed was reported.|Day 28|Intent-to-Treat Exposed population.|||Posterior probability||Standard Deviation|Mean
2676383|NCT01439373|Primary|Probability of Participants With HCV Genotype 1 Achieving RVR At Day 28, Nominal Analysis|The primary comparison of interest was performed using a Bayesian probability model. Probability of achieving undetectable HCV RNA distribution analyzed by nominal analysis was reported.|Day 28|Intent-to-Treat Exposed population.|||Posterior probability||Standard Deviation|Mean
2676384|NCT01439373|Primary|Number of Participant Achieving RVR at Day 28, (Primary and Supportive Analyses)|RVR was defined as the proportion of participants LOD <18 IU/mL for HCV RNA after 4 weeks of treatment (Day 28). Participants achieving RVR at Day 28 were considered treatment responders. Participants with missing HCV RNA values at Day 28 or discontinued before Day 28 were considered as treatment failure. Proportion of participants with HCV genotype 1 achieving RVR was the primary comparison of interest to show superiority of GSK2336805 over placebo in genotype 1 participants. The primary and supportive analysis differs from the nominal analysis as supportive analysis is assessed at Day 28 ± 2 (2 days visit window) whereas, the nominal analysis was assessed at Day 28.|Day 28|Intent-to-Treat Exposed population.|||Participants|||Count of Participants
2676385|NCT01439373|Primary|Number of Participant Achieving Rapid Virological Response (RVR) at Day 28, Nominal Analysis|RVR was defined as the proportion of participants below the assay lower limit of detection (LOD) <18 International units per milliliter (IU/mL) for Hepatitis C virus (HCV) ribonucleic acid (RNA) after 4 weeks of treatment (Day 28). Participants achieving RVR at Day 28 were considered treatment responders. Participants with missing HCV RNA values at Day 28 or discontinued before Day 28 were considered as treatment failure . Proportion of participants with HCV genotype 1 achieving RVR was the primary comparison of interest to show superiority of GSK2336805 over placebo in genotype 1 participants.|Day 28|Intent-to-Treat Exposed population comprised of all participants who meet study criteria and were randomly assigned to treatment in the study with documented evidence of had received at least 1 dose of randomized treatment and at least 1 post-baseline HCV RNA measurement.|||Participants|||Count of Participants
2676386|NCT01439360|Secondary|Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).|SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.|During the entire study period (approximately 6- 8 months per subject)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2676387|NCT01439360|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs).|pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = pIMDs that prevented normal activities. Related = symptom assed by the investigator as causally related to the study vaccination.|During the entire study period (approximately 6- 8 months per subject)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2676388|NCT01439360|Secondary|Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs)|MAVs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was defined as MAVs that prevented normal activities and related was defined as MAVs assessed by the investigator to be causally related to the study vaccination.|During the entire study period (approximately 6- 8 months per subject)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2676450|NCT01439009|Primary|Pulmonary Rales|Of the subjects who had pulmonary rales at baseline, the number of subjects whose symptom was resolved at completion of treatment. Statistical comparison was not done.|Day15||||participants|||Number
2676389|NCT01439360|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.|During the 28-day (Days 0-27) post-vaccination period|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2676390|NCT01439360|Secondary|Duration of Solicited General Symptoms|Duration was defined as number of days with any grade of general symptoms.|During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).|||Days||Full Range|Median
2676391|NCT01439360|Secondary|Duration of Solicited Local Symptoms|Duration was defined as number of days with any grade of local symptoms.|During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).|||Days||Full Range|Median
2676392|NCT01439360|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.|Solicited general symptoms assessed were Drowsiness, Irritability/fussiness, Loss of appetite and Temperature (Axillary). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination.|During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).|||Participants|||Count of Participants
2676393|NCT01439360|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.|Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that resulted crying when limb was moved/ spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. >50mm.|During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)|The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).|||Participants|||Count of Participants
2676394|NCT01439360|Secondary|Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)|"Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).~PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects"|At Day 0 and Day 28/56|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.|||Participants|||Count of Participants
2676395|NCT01439360|Secondary|Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only).|"MGI also known as the seroconversion factor [SCF] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).~POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects."|At Day 28/56 (POST)|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.|||Fold change||95% Confidence Interval|Geometric Mean
2676396|NCT01439360|Secondary|Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)|"Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4 fold increase in post vaccination reciprocal titer against the vaccine virus.~PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects"|At Day 28/56 (POST)|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.|||Participants|||Count of Participants
2676397|NCT01439360|Secondary|Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)|"A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).~PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects."|At Day 0 and Day 28/56|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.|||Participants|||Count of Participants
2676451|NCT01439009|Primary|Change in Liver Size From Baseline|The comparison of the average of amount of change from baseline. Statistical comparison was not done．|Day15||||cm||Standard Deviation|Mean
2676398|NCT01439360|Secondary|Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only)|"Titers were expressed as geometric mean antibody titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata).~PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects"|At Days 0 and 28/56|The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2676399|NCT01439360|Secondary|Number of Subjects With First Occurrence of RT-PCR Confirmed Severe Influenza A and/or B Due to Any Seasonal Influenza Strain.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.|||Participants|||Count of Participants
2676400|NCT01439360|Secondary|Number of Subjects With First Occurrence of Acute Otitis Media (AOM) With RT-PCR Confirmed Influenza A and/or B Infection Due to Any Seasonal Influenza Strain.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.|||Participants|||Count of Participants
2676401|NCT01439360|Secondary|Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Any Seasonal Influenza Strain.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.|||Participants|||Count of Participants
2676402|NCT01439360|Secondary|Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Any Seasonal Influenza Strain.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.|||Participants|||Count of Participants
2676403|NCT01439360|Secondary|Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.|||Participants|||Count of Participants
2676404|NCT01439360|Secondary|Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.|||Participants|||Count of Participants
2676405|NCT01439360|Secondary|Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.|||Participants|||Count of Participants
2676406|NCT01439360|Primary|Number of Subjects With RT-PCR Confirmed Influenza of Any Severity.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.|||Participants|||Count of Participants
2676407|NCT01439360|Primary|Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.|Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.|During the surveillance period (approximately 6 to 8 months)|The ATP cohort for efficacy – Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.|||Participants|||Count of Participants
2676452|NCT01439009|Primary|Jugular Venous Distension|The comparison of the average of amount of change from baseline. Statistical comparison was not done.|Day15||||cm||Standard Deviation|Mean
2676409|NCT01439282|Secondary|Use of Cold Cap for Alopecia|Alopecia (hair loss) is a potential side effect of some chemotherapy agents. Chemotherapeutic drugs are toxic and could potentially harm the hair follicles (wear hair grows from) resulting in the hair falling out. It can occur in small patches on various parts of the body or all over the body and is usually temporary when related to cancer treatment. Cold cap therapy is one form of therapy for alopecia involving hair loss from the scalp. Wearing a cap or head covering with cold packs before, during, or after chemotherapy may help prevent hair loss as the cold narrows the blood vessels in the skin on your head which may lead to less of the drug reaching the hair follicles. Alopecia was one of the most common adverse events (AEs) related to eribulin only.|On the day of study drug infusion treatments during Cycles 1 through 4|Safety analysis set included all participants who received at least one dose of study treatments and had at least one postbaseline safety assessment.|||Participants|||Number
2676410|NCT01439282|Primary|Percentage of Participants Who Achieved the Target Relative Dose Intensity (RDI) of 85%|Relative Dose Intensity (RDI) is defined as the amount of drug administered over a specific time and is expressed as the fraction of that recommended for standard of care. The RDI for each participant was calculated as follows: (1) based on each participant's body surface area (BSA), a total planned dose for both eribulin (Dep) and capecitabine (Dcp) calculated for a full 4-cycle regimen; (2) actual total dose of eribulin (Dea) and capecitabine (Dca) for the full 4-cycle regimen as collected on the case report form; (3) overall RDI = (Dea/Dep + Dca/Dcp)/2. For each individual participant, the regimen was considered feasible if that participant was able to achieve an RDI of at least 85% of the 4 cycles of eribulin plus capecitabine treatment. Missing doses due to any reason was counted as zero in the RDI calculation.|21-Day Cycle 1 through 21-Day Cycle 4|Full analysis set included all participants who received at least one dose of eribulin mesylate plus capecitabine.|||Percentage of participants||95% Confidence Interval|Number
2676411|NCT01439204|Secondary|Number of Participants With a Change From Baseline in QT Interval and Corrected (Fridericia) QT Interval (QTcF) - Safety Population|12-lead electrocardiograms were performed on a supine participant (5 minutes supine) at baseline (baseline = screening; Days -21 to -2) and at Day 71. QT interval and QTc were measured in mille seconds (msec). A change from baseline QT and QTc (corrected for heart rate by Fridericia formula) greater than (>) 30 msec or less than (<) 60 msec were presented, as well as values over 450 and 500 msec. QT interval on ECG image defined as: time from the beginning of the QRS (complex consisting of Q, R and S waves) to the end of the T wave.|Day 1 to Day 71|All participants who received study drug and had at least one ECG value.|||participants|||Number
2676412|NCT01439204|Secondary|Change From Baseline in Diastolic Blood Pressure on Days 1, 2, 15, 29, 57, and 71 - Safety Population|Blood pressure was obtained while the participant had been quietly seated for at least 5 minutes. Baseline was the 0 hour measurement on Day 1 (day of dosing) or if this value was missing, the last measurement before dosing. Blood pressure was measured in millimeters of mercury (mmHg) on Days 1, 2, 15, 29, 57, and 71.|Day 1 to Day 71|All participants who received study drug (safety population) and had diastolic assessment were included in the analysis. Day 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (N=33 in both arms); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).|||mmHg||Standard Deviation|Mean
2676413|NCT01439204|Secondary|Change From Baseline in Systolic Blood Pressure - Safety Population|Blood pressure was obtained while the participant had been quietly seated for at least 5 minutes. Baseline was the 0 hour measurement on Day 1 (day of dosing) or if this value was missing, the last measurement before dosing. Blood pressure was measured in millimeters of mercury (mmHg) on Days 1, 2, 15, 29, 57, and 71.|Day 1 to Day 71|All participants who received study drug (safety population) and had systolic assessment were included in the analysis. Days 1 and 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (N=33 in both arms); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).|||mmHg||Standard Deviation|Mean
2676414|NCT01439204|Secondary|Number of Participants With Marked Hematology Abnormalities on Days 2, 15, 29, 57, and 71 - Safety Population|Blood samples obtained: Days 2, 4, 8, 15, 22, 29, 43, 57 and 71. Male(M); Female (F). Reference ranges (low/high) for laboratory parameters for which participants were identified with marked abnormalities during the study: Leukocytes (quantitative White blood cells) (M/F) 4-11*10^3/microliters (µL); Neutrophils (absolute)(M/F) 1.4- 8.2*10^3/µL.|Day 2 to Day 72|All participants who received study drug (safety population) and had a laboratory assessment were included in the analysis. Day 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (Lonza arm N=34; Devens arm N=33); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).|||participants|||Number
2676415|NCT01439204|Secondary|Number of Participants With Marked Serum Chemistry Abnormalities on Days 2, 15, 29, 57 and 71 - Safety Population|Blood samples obtained: Days 1, 2, 4, 8, 15, 22, 29, 43, 57 and 71. International Units per liter (U/L); milligram per deciliter (mg/dL); Male(M); Female (F). Reference ranges (low/high) for laboratories for which participants were identified with marked abnormalities during the study: Blood Urea Nitrogen (M/F) 10-20mg/dL ; Creatine Kinase (F) 21-21 U/L,(M) 32-294 U/L; Direct Bilirubin (M/F) 0.1-0.4 mg/dL ; Fasting Glucose (M/F) 70-110 mg/dL; Lactate Dehydrogenase (M/F) 110-209 U/L.|Day 2 to Day 71|All participants who received study drug (safety population) and had a laboratory assessment were included in the analysis. Day 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (Lonza arm N=34; Devens arm N=33); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).|||participants|||Number
2676416|NCT01439204|Secondary|Number of Participants With Positive Abatacept-induced Immunogenicity Response|Immunogenicity determination was based on titers of anti-abatacept and anti- cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4-T) antibodies in serum over time. A participant had a positive abatacept-induced immunogenicity if 1 of the following criteria were met: missing baseline measurement and a positive response after baseline; negative baseline response and positive response after baseline; a baseline response and a positive response after baseline that has a titer value strictly greater than the baseline titer value. A validated, sensitive, electrochemiluminescence assay (ECL) method was used to analyze the antibodies in serum. Samples confirmed positive with ECL and with abatacept serum concentrations of less than equal to 1 µg/mL were further analyzed with a validated, in vitro, cell-based bioassay to analyze the sera containing the abatacept neutralizing activity. Samples obtained on Days 29, 57 and 71 post dose of abatacept on Day 1 (baseline).|Days 29, 57, 71|Immunogenicity Data Set: All participants with at least 1 postdose visit.|||participants|||Number
2676417|NCT01439204|Primary|Volume of Distribution at Steady-state (Vss) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|Vss was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Vss was measured in liters per kg body weight (L/kg).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.|||L/kg||Geometric Coefficient of Variation|Geometric Mean
2676418|NCT01439204|Primary|Total Body Clearance (CLT) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|CLT was the volume of abatacept cleared by the system, normalized by baseline body weight. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). CLT was measured in milliliters per hours per kilogram of body weight (mL/h/kg).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.|||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
2676419|NCT01439204|Primary|Terminal Phase Elimination Half-life (T-HALF) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|T-HALF was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). T-HALF was measured in hours (h).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.|||h||Standard Deviation|Mean
2676420|NCT01439204|Primary|Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity [AUC(0 - INF)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population|AUC (0 - INF) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - INF) was measured in µg*h/mL.|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2676421|NCT01439204|Primary|Area Under the Concentration-time Curve From Zero to the Last Time of the Last Quantifiable Concentration [AUC(0-T)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population|AUC (0 - T) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - T) was measured in micro grams*hour per milliliter (µg*h/mL).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2676422|NCT01439204|Primary|Area Under the Concentration-time Curve (AUC) From Time Zero to 28 Days [AUC(0-28 Days)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population|AUC (0 - 28) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - 28) was measured in micro grams*hours per milliliter (µg*h/mL).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2676423|NCT01439204|Primary|Time to Reach Maximum Concentration (Tmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|Tmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Tmax was measured in hours (h).|Day 1 to Day 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.|||h||Full Range|Median
2676424|NCT01439204|Primary|Maximum Observed Concentration (Cmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population|Cmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Cmax was measured in micro grams per milliliter (µg/mL).|Days 1 to 71|Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles. All completers had evaluable PK.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2676425|NCT01439165|Secondary|Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions|Injection site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection site reactions: Pain, Significant, prevents daily activity. Erythema and Swelling, >100 mm. Grade 3 Systemic reactions: Fever, ≥39°C or ≥102.1 F; Headache, Malaise, and Myalgia, Significant; prevents daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in the Safety Analysis Set.|||Percentage of participants|||Number
2676453|NCT01439009|Primary|Number of Subjects Whose Lower Limb Edema Severity Grading Improved by One or More Grade|Of the subjects who had lower limb edema at baseline, the number of subjects whose lower limb edema severity grading. Statistical comparison was not done.|Day15||||participants|||Number
2676454|NCT01439009|Primary|Body Weight|The comparison of the average of amount of change from baseline. Statistical comparison was not done.|Day15||||kg||Standard Deviation|Mean
2676426|NCT01439165|Primary|Percentage of Subjects With Pertussis Antigen Booster Response|"Anti-Pertussis antibodies (Pertussis toxoid, Filamentous Hemagglutinin [FHA], Pertactin, Fimbriae (types 2 and 3) were assessed using an enzyme-linked immunosorbent assay. Booster response is defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times if the pre-vaccination concentration is above the cutoff value, or at least 4 times if it is at or below the cutoff value.~Anti-pertussis toxoid booster response rates further to Adacel vaccination was compared to an expected booster rates based on study Td506 (PMID 15933223) since Td Adsorbed Vaccine does not contain any pertussis antigens."|1 month post-booster vaccination|Booster response rate was assessed in the Per protocol analysis set|||Percentage of subjects|||Number
2676427|NCT01439165|Primary|Geometric Mean Concentrations (GMC) of Anti Pertussis Antibodies|Anti-Pertussis antibodies (Pertussis toxoid, Filamentous Hemagglutinin (FHA), Pertactin, Fimbriae types 2 and 3) were assessed using an enzyme-linked immunosorbent assay. Anti-pertussis GMCs further to Adacel vaccination was compared to an historical control group with Daptacel (NCT00255047 for pertussis toxoid and PMID 8538705 for FHA, Pertactin and Fimbriae) since Td Adsorbed Vaccine does not contain any pertussis antigens.|1 month post-booster vaccination|Geometric mean concentrations were assessed in the Per Protocol Analysis Set.|||Concentrations (1/dil)||95% Confidence Interval|Geometric Mean
2676428|NCT01439165|Primary|Percentage of Participants With Diphtheria and Tetanus Booster Response|Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus antibodies were assessed using an enzyme-linked immunosorbent assay. A booster response was defined as a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with pre-vaccination antibody concentrations ≤2.56 IU/mL for diphtheria and ≤ 2.7 IU/mL for tetanus. If the pre vaccination antibody concentrations were > 2.56 IU/mL for diphtheria and > 2.7 IU/mL for tetanus, then a 2-fold increase in response rate was defined as a booster response.|1 month post-booster vaccination|Booster response rates were assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2676429|NCT01439165|Primary|Percentage of Participants With Diphtheria and Tetanus Seroprotection|Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus antibodies were assessed using an enzyme-linked immunosorbent assay. Seroprotection was defined as the following: Anti-Diphtheria and Anti-Tetanus ≥ 0.1 IU/mL.|1 month post-booster vaccination|Seroprotection was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2676430|NCT01439126|Secondary|Long-term Safety of KAPVAY in Children and Adolescents With ADHD Based on the Assessment of Changes in the Columbia Suicide Severity Rating Scale (C-SSRS)|"The outcome reported is the number of subjects that responded Yes to the question Do you have a wish to be dead at Visit 20.~C-SSRS is a clinician-rated instrument designed to provide consistent and systematic assessment of both suicidal ideation and behavior within a study, as well as across studies. The scale is a feasible, low burden series of questions that appropriately assess and track all suicidal events, including ideation. Suicidal ideation is assessed according to yes/no responses to 5 questions of increasing severity (from a wish to die to an active thought of killing oneself with plan and intent) as follows:~Wish to be Dead~Non-Specific Active Suicidal Thoughts~Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act~Active Suicidal Ideation with Some Intent to Act, without Specific Plan~Active Suicidal Ideation with Specific Plan and Intent"|Visit 20 (Week 40)|Double-Blind Full Analysis Set|||participants|||Number
2676431|NCT01439126|Secondary|Long-term Safety of KAPVAY in Children and Adolescents With ADHD Based on the Assessment of Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Study Drug Discontinuation, Clinically Significant Changes or Abnormalities in Vital Signs||From study start to study end (40 weeks)|Double-Blind Full Analysis Set|||Participants|||Number
2676432|NCT01439126|Secondary|Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the Epworth Sleepiness Scale for Children (ESS-C)|"Change in the ESS-C scale from randomization to end of randomized-withdrawal period. The ESS-C is a simple eight-tem Likert scale designed to assess daytime sleepiness in children aged 2-18 years. The scale takes less than two minutes to be completed by patient or by parent rating. Sleepiness is a common symptom in both medicated and unmedicated children with ADHD given the predominance of impaired sleep quality. The total score achieved when the chance of dozing in each situation is added up serves as the outcome measure.~The ESS-C comprises 8 items describing various daytime activities. Item scores ranging from 0 (would never doze or sleep) to 3 (high chance of dozing or sleeping). A total score is derived as the sum of the items, with higher total scores indicative of a greater level of sleepiness (worse outcome). Total scores range from 0 to 24."|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set|||units on a scale||Standard Deviation|Mean
2676433|NCT01439126|Secondary|Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the Weiss Functional Impairment Rating Scale-Parent (WFIRS-P)|"The WFIRS-P is designed to assess the impact of child's behavior or emotional problems on 7 domains related to function: Family (10 items), School Learning (4 items), School Behavior (6 items), Life Skills (10 items), Child's Self-concept (3 items), Social Activities (7 items), and Risky Activities (10 items). Each item was scored on a scale ranging from 0 (never or not at all) to 3 (very often or very much). Each scale score was calculated as the average for that scale. The total score is the average of all non-missing items. Higher scores are associated with greater impact of disease on functioning."|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set|||units on a scale||Standard Deviation|Mean
2676434|NCT01439126|Secondary|Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the Clinical Global Impressions-Severity of Illness Scale (CGI-S)|"The CGI-S is a clinician rated instrument designed to assess the subject's current illness state. The CGI-Severity (CGI-S) asks the clinician one question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.~This rating is based upon observed and reported symptoms, behavior, and function in the past seven days."|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set|||scores on a scale||Standard Deviation|Mean
2676435|NCT01439126|Secondary|Long-term Efficacy of KAPVAY in Children and Adolescents With ADHD as Measured by the Change From Randomization to the End of the Randomized-withdrawal Period on the ADHD-Rating Scale-4th Edition (ADHD-RS-IV)|The ADHD-RS-IV (clinician version), has been widely used as a measure of efficacy in clinical trials of treatments in children and adolescents with ADHD. It is derived from the 18 inattentive and hyperactive/impulsive diagnostic criteria for ADHD from the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR). The clinician version of the ADHD-RS-IV has a large base of normative data and has demonstrated reliability and discriminant validity in children and adolescents. The ADHD-RS-IV of 2 subscales: inattention - 9 items and hyperactivity-impulsivity - 9 items. Each gives a score ranging from 0 (none, never or rarely) to 3 (severe, very often), for a total score ranging from 0 to 54 (higher score worse and a lower score more favourable). Two subscales are summed.|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set|||scores on a scale||Standard Deviation|Mean
2676436|NCT01439126|Secondary|To Evaluate the Long-term Efficacy of KAPVAY in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) as Measured by the Time to Treatment Failure From the Start of Randomized-withdrawal Period|Time to treatment failure was calculated as follows: Treatment failure (not premature termination) = visit date where the failure criteria was met - visit 9 date + 1; Treatment failure (premature termination) = termination date - visit 9 date + 1|Time From randomization to treatment failure (up to 26 weeks)|Double-Blind Full Analysis Set|||days||95% Confidence Interval|Median
2676437|NCT01439126|Primary|Long-term Maintenance of Efficacy of KAPVAY in Children and Adolescents With Attention Deficit Hyperactivity Disorder (ADHD) as Measured by the Percentage of Treatment Failures in the KAPVAY vs. Placebo Groups|"Treatment failure a ≥30 percentage increase (worsening)(ADHD-RS-IV, clinician version) total score and a ≥2 point increase (worsening) in Clinical Global Impressions-Severity of Illness Scale (CGI-S) at any two consecutive visits during the randomized-withdrawal period.~The ADHD-RS-IV of 2 subscales: inattention - 9 items and hyperactivity-impulsivity - 9 items. Each gives a score ranging from 0 (none, never or rarely) to 3 (severe, very often), for a total score ranging from 0 to 54 (higher score worse).~The CGI-S is a 7-point scale,1 (Normal, not at all ill) to 7 (extremely ill patients).The CGI-Severity (CGI-S) asks the clinician one question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients."|From randomization to end of the randomized-withdrawal period (26 weeks)|Double-Blind Full Analysis Set. This set included all randomized subjects who took at least 1 dose of study medication during the double blind (randomized-withdrawal) phase|||% of Participants|||Number
2676438|NCT01439087|Primary|Feasibility and Sensitivity of OFDI Imaging in the Colon|OFDI Images are analyzed and compared to standard of care biopsies in order to differentiate hyperplastic polyps from adenomas or to identify serrated polyps. A total of 15 subjects were consented, but upon inspection of the colon only 2 participants met the eligibility criteria and participated.|During the OFDI imaging session which should take an average of 5 mintues||||Participants|||Count of Participants
2676439|NCT01439074|Secondary|% of Study Burn Healed After One Week||1 week||||percentage of study burn healed||Standard Deviation|Mean
2676440|NCT01439074|Secondary|Number of Dressing Changes|Number of dressing changes including first assembly|4 weeks|ITT population/Safety population. ITT includes all Subjects, subject to at least one post-randomisation treatment and that provide some data for the primary endpoint.|||applications||Standard Deviation|Mean
2676441|NCT01439074|Secondary|Percent of Burn Epithelised/Healed|Healing will be defined as 95% or more epithelialisation|4 weeks||||percentage of study burn healed||Standard Deviation|Mean
2676442|NCT01439074|Primary|Time to Healing|Healing will be defined as number of days|4 weeks|ITT population/Safety population. ITT includes all Subjects, subject to at least one post-randomisation treatment and that provide some data for the primary endpoint.|||days||Standard Deviation|Mean
2676443|NCT01439035|Primary|Number of Subjects With Changes of Villous Architecture Undergoing OFDI Imaging|"OFDI images analyzed and compared to standard of care biopsies to identify celiac disease caracteristic mucosal lesions.~In this pilot study, we demonstrated the feasibility of using OFDI for visualizing changes of villous architecture in CD patients in vivo"|during imaging session|Subjects 7 or over 7 years old with Celiac Disease|||Participants|||Count of Participants
2676444|NCT01439009|Primary|Number of Subjects Whose New York Heart Association (NYHA) Classification Improved by One More Grade From Baseline|"New York Heart Association (NYHA) Classification is below ClassI：No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).~ClassII：Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).~ClassIII：Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.~ClassIV：Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases."|The day after last IMP administration and Baseline||||participants|||Number
2676445|NCT01439009|Primary|Dypnea|Of the subjects who had dyspnoea at baseline, the number of subjects whose symptom was resolved at completion of treatment. Statistical comparison was not done.|Day15||||participants|||Number
2676446|NCT01439009|Primary|Plasma Brain Natriuretic Peptide (BNP) Concentration|The comparison of the average of amount of change from baseline. Statistical comparison was not done.|Day15||||pg/mL||Standard Deviation|Mean
2676447|NCT01439009|Primary|Pulmonary Congestion|Of the subjects who had pulmonary congestion at baseline, the number of subjects whose pulmonary congestion severity grading showed an improvement of one grade or more (eg, moderate to mild) at completion of treatment. Statistical comparison was not done.|Day15||||participants|||Number
2676448|NCT01439009|Primary|Cardiothoracic Ratio|"Investigator majored Thoracic length and Cardiac length from chest X-ray. Cardiothoracic Ratio was calculated from Cardiac length/Thoracic length*100. Lowering of Cardiothoracic Ratio suggests recovery from heart congestion.~The comparison of the average of amount of change from baseline. Statistical comparison was not done."|Day15||||Percentage||Standard Deviation|Mean
2676455|NCT01439009|Primary|Mortality （Number of Death）|Statistical comparison was not done.|Week26||||participants|||Number
2676456|NCT01439009|Primary|Cummulative Incidence of Events at Week 26|"From start day of IMP administration to final day of follow up period, 1) and 2) below were defined as event~Death from cardiovascular events~Worsening of heart failure~The day of re-hospitalization due to worsening of heart failure~The day of medication below due to worsening of heart failure Phosphodiesterase III inhibitors (Injection), Catecholamine preparations (Injection), Colforsin preparations (Injection), Diuretics (Injection), Human atrial natriuretic peptide preparations (Injection)：Calperitide (Injection)"|Week 26||||Percentage of events at 26 weeks|||Number
2676457|NCT01438996|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)||During the 28-day period after vaccination||||participants|||Number
2676458|NCT01438996|Secondary|Number of Subjects Reporting AE|AE during 28 days after vaccination(including solicited reactions during 7 days after vaccination)|During the 28-day period after vaccination||||participants|||Number
2676459|NCT01438996|Secondary|Number of Subjects Reporting Any (Local, Systemic and Other) Post Vaccination Reaction|Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia, fatigue and fever.|During the 7-day period after vaccination||||participants|||Number
2676460|NCT01438996|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers||At 28 days after vaccination as compared to baseline||||percentage of subjects||95% Confidence Interval|Number
2676461|NCT01438996|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers||At 7 days after vaccination as compared to baseline||||percentage of subjects||95% Confidence Interval|Number
2676462|NCT01438996|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers||At 3 days after vaccination as compared to baseline||||percentage of subjects||95% Confidence Interval|Number
2676463|NCT01438996|Primary|Anti-Vi ELISA GMC|To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 28 after vaccination as as measured by ELISA|At 28 days after vaccination||||ELISA Units/mL||95% Confidence Interval|Geometric Mean
2676464|NCT01438996|Primary|Anti-Vi ELISA GMC|To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 7 after vaccination as as measured by ELISA|At 7 days after vaccination||||ELISA Units/mL||95% Confidence Interval|Geometric Mean
2676465|NCT01438996|Primary|Anti-Vi ELISA Geometric Mean Concentration (GMC)|To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 3 after vaccination as as measured by enzyme-linked immunosorbent assay (ELISA)|At 3 days after vaccination||||ELISA Units/mL||95% Confidence Interval|Geometric Mean
2676466|NCT01438840|Secondary|Number of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L at Day 8|Participants with platelet response at Day 8 are defined as those who had a platelet count greater than or equal to 50 x 10^9/L at day 8 in the absence of rescue therapy on or before Day 8.|Week 1 (Day 8)|Full Analysis Set (Core Study): All participants who were randomized into the study.|||Participants|||Count of Participants
2676467|NCT01438840|Secondary|Number of Participants With a Reduction in Use of Concomitant Immune/Idiopathic Thrombocytopenic Purpura (ITP) Medication|Only participants on concomitant ITP medications at baseline were included.|Week 1 through Week 26|Full Analysis Set (Core Study): All participants who were randomized into the study.|||Participants|||Count of Participants
2676468|NCT01438840|Primary|Number of Weeks With Platelet Count Greater Than or Equal to 50 x 10^9/L During 6-Month Treatment Period|The cumulative number of weeks of platelet response is defined as the total numbers of weeks in which the platelet count is greater than or equal to 50 x 10^ 9/L during 6 months of treatment of core study in the absence of rescue therapy.|Week 1 to Week 26|Full Analysis Set (Core Study): All participants who were randomized into the study.|||Weeks||Full Range|Median
2676469|NCT01438814|Secondary|Change From Baseline in HbA1c Over Time|Means are adjusted by treatment and continuous baseline HbA1c|Baseline, 2 weeks and 8 weeks|Patients from FAS1000 (LOCF)|||percent||Standard Error|Mean
2676470|NCT01438814|Secondary|Composite Endpoint of Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment) and no Occurrence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by Investigators During 14 Weeks|The proportion of patients who achieved all the targets in a composite endpoint (HbA1c lowered by at least 0.8% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment).|14 weeks|Patients from FAS1000 (NCF)|||participants|||Number
2676471|NCT01438814|Secondary|Change From Baseline in Body Weight by Visit at Week 14|Means are adjusted by treatment, continuous baseline HbA1c and continuous baseline weight|Baseline and 14 weeks|FAS1000 having values for weight at baseline and week 14.|||kg||Standard Error|Mean
2676472|NCT01438814|Secondary|Composite Endpoint of Occurence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment) and no Occurence of Moderate and Severe Metformin Pre-specified GI Side Effects Assessed by the Investigators During 14 Weeks|The proportion of patients who achieved all the targets in a composite endpoint (HbA1c lowered by at least 0.5% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment).|14 weeks|Patients from FAS1000 (NCF)|||participants|||Number
2676473|NCT01438814|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.8% After 14 Weeks of Treatment)|The proportion of patients who achieved a relative efficacy response (HbA1c lowering by at least 0.8% after 14 weeks of treatment).|14 weeks|Patients from the FAS1000 (NCF)|||participants|||Number
2676474|NCT01438814|Secondary|Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 14 Weeks of Treatment)|The proportion of patients who achieved a relative efficacy response (HbA1c lowering by at least 0.5% after 14 weeks of treatment).|14 weeks|Patients from FAS1000 (NCF)|||participants|||Number
2676475|NCT01438814|Secondary|Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <6.5% After 14 Weeks of Treatment, and no Occurrence of Moderate or Severe Metformin Pre-specified GI Side Effects Assessed by Investigators|The proportion of patients who achieved all the targets in a composite endpoint (HbA1c below 6.5% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe GI side effects of metformin, as assessed by the investigators during 14 weeks of treatment).|14 weeks|Patients from FAS1000 (NCF) having a baseline HbA1c>=6.5%.|||participants|||Number
2676476|NCT01438814|Secondary|Metformin Pre-specified GI Symptom Intensity Score Assessed by Patients During 14 Weeks of Treatment|The intensity of the GI side effects was also assessed by the patients using VAS scaled from 0 to 10; higher scores indicate more severe events. Means are adjusted by treatment and continuous baseline HbA1c.|14 weeks|Patients from the FAS1000 using original results (OR) and having GI adverse events which were assessed for severity by the patient.|||units on a scale||Standard Error|Mean
2676477|NCT01438814|Secondary|Metformin Pre-specified GI Symptom Intensity Score Assessed by Investigators During 14 Weeks of Treatment|Patients could experience multiple events, therefore, multiple answers were possible for each patient.|14 weeks|Patients from FAS1000 and having GI adverse events which were assessed for severity by the investigator.|||events|Participants||Number
2676478|NCT01438814|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 14 Weeks of Treatment|Means are adjusted by treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose.|Baseline and 14 weeks|Patients from FAS1000 with LOCF|||mg/dL||Standard Error|Mean
2676479|NCT01438814|Secondary|Occurence of Metformin Pre-specified Moderate to Severe GI Side Effects Assessed by Investigators During 14 Weeks of Treatment|Proportion of patients who experienced at least one metformin pre-specified moderate or severe GI side effect during 14 weeks|14 weeks|Patients from FAS1000|||participants|||Number
2676480|NCT01438814|Secondary|Composite Endpoint of Occurrence of Treat to Target Efficacy Response, That is an HbA1c Under Treatment of <7.0% After 14 Weeks of Treatment, on no Occurrence of Moderate or Severe Gastrointestinal (GI) Side Effects During 14 Weeks of Treatment|The proportion of patients who achieved all the targets in a composite endpoint (HbA1c below 7.0% after 14 weeks of treatment; no occurrence of pre-specified moderate or severe gastrointestinal (GI) side effects of metformin, as assessed by the investigators during 14 weeks of treatment)|14 weeks|Patients from FAS1000 with non-completer considered as failure (NCF) having a baseline HbA1c>=7.0%.|||participants|||Number
2676481|NCT01438814|Primary|Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) After 14 Weeks Treatment|Adjusted mean change in HbA1c from baseline at Week 14 was analysed using an ANCOVA model. The Model included treatment and continuous baseline HbA1c.|Baseline and 14 weeks|FAS1000mg with last observation carried forward (LOCF): all patients randomised and treated who had a baseline at least 1 on-treatment HbA1c value and who tolerated a daily metformin dose of at least 1000 mg at the end of the titration phase.|||percent||Standard Error|Mean
2676482|NCT01438710|Primary|Evaluation of Hand Tremor and Stable Kidney Transplant Patients When Switched From Prograf to LCP-Tacro.|"The primary efficacy endpoint is the mean change from baseline (ie Day 7) in the Fahn-Tolosa-Marin Clinical Rating Scale (FTM) for overall tremor score 7 days after (ie, Day 14) LCP-Tacro conversion.~The overall FTM score was 0 to 100 where higher scores denoted worst/more severe tremor.~Below the mean total score and standard deviation for each treatment is given in addition to the mean change."|14 days|"Of the 40 patients who completed the study period, 38 patients were evaluable for efficacy evaluation and included in the modified intention to treat (mITT) population.~The outcome measure is given as total score below."|||units on a scale||Standard Deviation|Mean
2676483|NCT01438541|Secondary|Evaluate the Dressing Shape|Investigator and Nurses evaluated the shape of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent|14 days||||participants|||Number
2676484|NCT01438541|Secondary|Overall Experience of Use of the Dressing|Investigator and Nurses evaluate the overall Experience of using of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent, Not measured|14 days||||participants|||Number
2676485|NCT01438541|Primary|Erythema ( No/Yes)|Total improvement of erythema|14 days|Vulnerable subjects with high risk of skin breakdown.|||participants|||Number
2676486|NCT01438489|Secondary|Accumulation Ratio of Trough Concentration (Ctrough,AR) of Anifrolumab at Day 169 and 365|Accumulation ratio for trough concentration (Ctrough,AR) of anifrolumab after multiple administration at Day 169 and 365 was calculated.|Pre-infusion and 15 minutes post-infusion on Day 169 and 365|"The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."|||Ratio||Full Range|Median
2676487|NCT01438489|Secondary|Trough Concentration (Ctrough) of Anifrolumab at Day 29, 169 and 365|Trough concentration (Ctrough) of anifrolumab at Day 29, 169 and 365 were calculated.|Pre-infusion and 15 minutes post-infusion on Day 29, 169 and 365|"The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."|||microgram per milliliter||Standard Deviation|Mean
2676488|NCT01438489|Secondary|Accumulation Ratio of Maximum Observed Plasma Concentration (Cmax,AR) of Anifrolumab|Accumulation ratio for maximum plasma concentration (Cmax,AR) of anifrolumab after multiple administration at Day 169 and 337 was calculated.|Pre-infusion and 15 minutes post-infusion on Day 169 and 337|"The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."|||Ratio||Full Range|Median
2676489|NCT01438489|Secondary|Maximum Observed Plasma Concentration (Cmax) of Anifrolumab at Day 1, 169 and 337|Maximum plasma concentration (Cmax) was defined as the peak plasma level of anifrolumab, derived from plasma concentration -time data.|Pre-infusion and 15 minutes post-infusion on Day 1, 169 and 337|"The Pharmacokinetic population included all treated participants with at least 1 Pharmacokinetic assessment. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."|||micrograms/milliliter (mcg/mL)||Standard Deviation|Mean
2676490|NCT01438489|Secondary|Neutralization Ratio of 21-Gene Type I Interferon (IFN) Signature for Participants With Positive Baseline Pharmacodynamic (PD) Gene Signature|The PD positive and negative gene signature was determined by comparing the expression of type I IFN-inducible genes in a 21-gene panel in study participants relative to pooled normal blood collected from healthy participants.|Days 29, 85, 141, 169, 253, 337 (treatment phase), on Days 365, 396, and 422 (follow up period)|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure and n signifies evaluable participants for the specified category of the arms respectively."|||Ratio||Standard Deviation|Mean
2676491|NCT01438489|Secondary|Percentage of SLE Participants With Positive Anti-drug Antibody (ADA)|Anti-drug antibody responses to anifrolumab in serum were evaluated.|Days 1, 85, 141, 169, 253, 337 (Treatment Phase), 365, 396, and 422 (Follow-up Period)|"The safety population included participants who received any investigational product. Here, N and “n” signifies evaluable participants for this outcome measure and for specified category of the arms respectively. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in Anifrolumab 1000 mg group."|||Percentage of Participants|||Number
2676492|NCT01438489|Secondary|Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)|Any medically significant changes from the screening ECG was recorded as TEAEs. An abnormal ECG findings such as QT prolonged were reported as treatment emergent adverse events.|Day 1 (Baseline) to Day 422 (End of Study)|"The safety population included participants who received any investigational product. Here, N signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group."|||Participants|||Number
2676493|NCT01438489|Secondary|Number of Participants With Vital Signs Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)|Vital sign parameters are temperature, blood pressure, respiratory rate, heart rate and weight. Vital signs abnormalities were reported as TEAEs.|Day 1 (Baseline) to Day 422 (End of Study)|"The safety population included participants who received any investigational product. Here, N signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group."|||Participants|||Number
2676494|NCT01438489|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities in Investigations Reported as Treatment-Emergent Adverse Events|Any medically significant change in laboratory evaluations were recorded as Treatment emergent adverse events.|Day 1 (Baseline) to Day 422 (End of Study)|"The safety population included participants who received any investigational product. Here, N signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group."|||Participants|||Number
2676495|NCT01438489|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs) and Treatment-Emergent Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a study participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. A serious AE (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly (in offspring of participant). AEs may be treatment emergent (TE) [that is, occurring after initial receipt of investigational product] or non-TE. An AESI is one of scientific and medical concern specific to understanding biologics and requires close monitoring and rapid communication by investigator to sponsor.|Day 1 (Baseline) to Day 422 (End of Study)|"The safety population included participants who received any investigational product. Here, N signifies evaluable participants for this outcome measure. One participant from Placebo group received Anifrolumab 1000 mg once and hence, included it in the Anifrolumab 1000 mg group."|||Participants|||Number
2676496|NCT01438489|Secondary|Percentage of Participants on Oral Corticosteroids (OCS) >=10 mg/Day of Prednisone or Equivalent at Baseline Who Were Able to Taper to Less Than or Equal to (<=) 7.5 mg/Day at Day 365|Participants on OCS >=10 mg/day of prednisone or equivalent at baseline who were able to taper to <= 7.5 mg/day at Day 365 were evaluated.|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure."|||Percentage of Participants|||Number
2676497|NCT01438489|Secondary|Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index [SRI (4)] Response With Oral Corticosteroids (OCS) Tapering at Day 365|An SRI (4) Responder was defined as a participant who had 1) a reduction in baseline SLEDAI-2K disease activity score of >= 4 points; 2) no worsening of disease from baseline as measured by the MDGA (worsening was defined as an increase of >= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index A organ system score and no more than one new or worsening BILAG-2004 Index B organ system score. OCS tapering requires a sustained reduction of OCS from Day 281 through Day 365 (less than 10 mg/day and less or equal to the dose received on Day 1). SRI was analyzed by a logistic regression model.|Day 365|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure."|||Percentage of Participants|||Number
2676498|NCT01438489|Primary|Percentage of Type I Interferon (IFN) Test High Participants Achieving an Systemic Lupus Erythematosus Responder Index (SRI) (4) Response With Oral Corticosteroids (OCS) Tapering at Day 169|Type I IFN signature in whole blood assessed by using a 4-gene diagnostic test. The blood samples collected were to be used to prospectively identify participants as IFN test-high or test-low. The results of this test were used to stratify participants. An SRI (4) Responder was defined as a participant who had 1) a reduction in baseline SLEDAI-2K disease activity score of >= 4 points; 2) no worsening of disease from baseline as measured by the Physician Global Assessment (MDGA) (worsening was defined as an increase of >= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index A organ system score and no more than one new or worsening BILAG-2004 Index B organ system score. OCS tapering requires a sustained reduction of OCS from Day 85 through Day 169 [less than 10 mg/day and less or equal to the dose received on Day 1]. SRI was analyzed by a logistic regression model.|Day 169|"The mITT population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure."|||Percentage of Participants|||Number
2676530|NCT01438307|Primary|Objective Response Rate|The objective response is defined as the percentage of patients that achieve a complete and/or partial response according to The Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).|Baseline up to 28 months||||participants|||Number
2676821|NCT01436279|Secondary|Operative Time|Interval from initiation of vacuum aspiration to speculum removal|Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.||||minutes||95% Confidence Interval|Median
2676499|NCT01438489|Primary|Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index [SRI (4)] Response With Oral Corticosteroids (OCS) Tapering at Day 169|An SRI (4) responder defined as a participant who had 1) a reduction in baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of greater than or equal to (>=) 4 points; 2) no worsening of disease from baseline as measured by the Physician Global Assessment (MDGA) (worsening was defined as an increase of >= 0.3 from baseline on a 0 to 3.0 visual analog scale); and 3) no new British Isles Lupus Assessment Group 2004 (BILAG-2004) Index 'A' organ system score and no more than one new or worsening BILAG-2004 Index 'B' organ system score. OCS tapering requires a sustained reduction of OCS from Day 85 through Day 169 [less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1]. SRI was analyzed by a logistic regression model.|Day 169|"The modified Intent-To-Treat (mITT) population included all randomized participants who received any investigational product and had a baseline primary efficacy measurement. Here, N signifies evaluable participants for this outcome measure."|||Percentage of Participants|||Number
2676500|NCT01438476|Primary|Postoperative Pain Experience|The Area Under the Curve (AUC) pain score during the first 48 hours after surgery. Post operative pain was measured during the first 48 hours per unit acuity guidelines. Typically this was at a minimum of every four hours yielding an average number of measures during the first 48 hours. The scale is 0-480 low scores are better.|First 48 hours after surgery||||score on a scale* hour||Inter-Quartile Range|Median
2676501|NCT01438424|Secondary|Off-treatment Follow-up: Mean Change in HBV DNA (Amendment 11 Cohort)|The Amendment 11 Cohort consisted of participants who were HBeAg negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing.|End of dosing to Weeks 48 and 96 off-treatment follow-up|Participants who were HBeAg negative and who had liver disease, a minimum of 192 weeks of entecavir treatment, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks before end of dosing, and had serum ALT levels ≤1.0*ULN at the end of study drug dosing. (n=number of evaluable participants)|||Log10 copies/mL||Standard Error|Mean
2676502|NCT01438424|Secondary|Off-treatment Follow-up: Percentage of Participants With Sustained HBV DNA <1,000, <300, and <10,000 Copies/mL by PCR Assay and With ALT ≤1*ULN (Amendment 11 Cohort)|The Amendment 11 Cohort consisted of participants who were HBeAg negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR Assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing. ULN=upper limit of normal.|End of dosing to Weeks 48 and 96 off-treatment follow-up|Participants who were HBeAg negative and who had liver disease, a minimum of 192 weeks of entecavir treatment, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks before end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing. (n=number of evaluable participants)|||Percentage of participants|||Number
2676503|NCT01438424|Primary|Off-treatment Follow-up: Percentage of Participants With Sustained Hepatitis B Virus (HBV) DNA <10,000 Copies by Polymerase Chain Reaction (PCR) Assay (Amendment 11 Cohort)|The Amendment 11 Cohort consisted of participants who were hepatitis B e antigen (HBeAg) negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing.ALT=alanine aminotransferase; ULN=upper limit of normal.|End of dosing to Week 48 off-treatment follow-up|Participants who were HBeAg negative and who had compensated liver disease, a minimum of 192 weeks (4 years) of treatment with entecavir, HBV DNA <300 copies/mL by PCR assay for ≥48 weeks before end of dosing and on the last observed result ≤24 weeks prior to end of dosing, and serum ALT levels ≤1.0*ULN at the end of study drug dosing.|||Percentage of participants|||Number
2676504|NCT01438424|Secondary|Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort)|The Lamivudine Retreatment Switch Cohort consisted of participants who were nucleoside-naive HBeAg negative and enrolled from BMS study AI463-027 (NCT00035789) with >60 days between end of dosing in AI463-027 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study.|Baseline to Week 144|Participants enrolled from study AI463-027 who were nucleoside-naive HBeAg-negative and had >60 days off treatment between the last dose in AI463-027 and the first dose in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
2676505|NCT01438424|Secondary|Week 96: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Retreatment Switch Cohort)|The Lamivudine Retreatment Switch Cohort consisted of participants who were nucleoside-naive HBeAg negative and enrolled from BMS study AI463-027 (NCT00035789) with >60 days between end of dosing in AI463-027 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study.|Baseline to Week 96|Participants enrolled from AI463-027 who were nucleoside-naive HBeAg-negative, received lamivudine, and had >60 days between end of dosing in AI463-027 and the switch to entecavir in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
2676506|NCT01438424|Primary|Week 192: Number of Participants With Death As Outcome, Any AE, Grade 3-4 AEs, SAEs, Discontinuations Due to AEs, and Abnormalities in Selected Laboratory Test Results|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. CTC Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. ALT=alanine aminotransferase; ULN=upper limit of normal.|Continuously from Day 1 through Week 192|Participants who enrolled from Phase 3 studies of nucleoside-naive HBeAg-positive (AI463-022) and HBeAg-negative (AI463-027) participants and received at least 1 dose of study drug in the current study up to Week 192. (n=number of evaluable participants)|||Participants|||Number
2676507|NCT01438424|Secondary|Week 144: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort)|The Lamivudine Continuous Switch Cohort consisted of participants who were nucleoside-naive, HBeAg-positive and received lamivudine in BMS study AI463-022 (NCT00035633) and enrolled in the current study with ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study.|Baseline to Week 144|Participants enrolled from AI463-022 who received lamivudine, were nucleoside-naive HBeAg-positive, and had ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
2676508|NCT01438424|Secondary|Week 96: Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay, Loss of HBeAg, HBeAg Seroconversion, and ALT ≤1.0*ULN (Lamivudine Continuous Switch Cohort)|The Lamivudine Continuous Switch Cohort consisted of participants who were nucleoside-naive, HBeAg-positive and received lamivudine in BMS study AI463-022 (NCT00035633) and enrolled in the current study with ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as switch therapy in the current study.|Baseline to Week 96|Participants enrolled from AI463-022 who received lamivudine, were nucleoside-naive HBeAg-positive, and had ≤35 days off treatment between end of dosing in AI463-022 and the switch to entecavir in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
2676509|NCT01438424|Secondary|Percentage of Participants Who Achieved HBV DNA <300 and <10^4 Copies/mL by PCR Assay and ALT ≤1.0*Upper Limit of Normal (ULN) (Entecavir Retreatment Cohort)|The Entecavir Retreatment Cohort consisted of participants who were nucleoside-naive, HBeAg-negative and enrolled from BMS study AI463-027 with >60 days off treatment between the last dose in AI463-027 and the first dose in the current study. This cohort permitted assessment of entecavir, 1.0 mg, provided as retreatment in the current study.|Baseline to Weeks 48, 96, and 144|Participants enrolled from study AI463-027 who were nucleoside-naive, HBeAg-negative and had >60 days off treatment between the last dose in AI463-027 and the first dose in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
2676510|NCT01438424|Secondary|Percentage of Participants Who Achieved HBV DNA <300 Copies/mL by PCR Assay, Loss of HBeAG, Seroconversion, and ALT ≤1.0*Upper Limit of Normal (ULN) (Entecavir Continuous Treatment Cohort)|The Entecavir Continuous Treatment Cohort consisted of participants from study AI463-022 (NCT00035633) who were nucleoside-naive HBeAg-positive and enrolled in the current study with ≤35 days off treatment between the last dose in AI463-022 and the first dose in the current. This cohort is considered to be on continuous entecavir treatment and permitted assessment of continuous administration of entecavir in AI463-022 and the current study.|Baseline to Weeks 48, 96, 144, 192, and 240|Participants enrolled from study AI463-022 who were nucleoside-naive, HBeAg-positive and enrolled in the current study with ≤35 days off treatment between the last dose in AI463-022 and the first dose in the current study and were evaluable. (n=number of evaluable participants)|||Percentage of participants|||Number
2676511|NCT01438424|Primary|Week 144: Number of Participants With Death As Outcome, Any AE, Grade 3-4 AEs, SAEs, Discontinuations Due to AEs, and Abnormalities in Selected Laboratory Test Results|An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. AST=aspartate aminotransferase; ULN=upper limit of normal.|Continuously from Day 1 through Week 144|Participants enrolled up to Week 144 who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Participants|||Number
2676512|NCT01438424|Secondary|Overall Study: Percentage of Participants With a Confirmed ≥1 log10 Increase From Nadir in HBV DNA by PCR Assay||Baseline to Week 144|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
2676513|NCT01438424|Primary|Overall Study: Number of Participants With Normal Electrolyte and Fasting Glucose Values at Baseline and Abnormalities in Electrolyte and Fasting Glucose Laboratory Test Results at End of Dosing|Hypochloremia: Grade (Gr) 1=90-93; Gr 2=85-<90; Gr 3=80-<85; Gr 4=40-<80. Hyperchloremia: Gr 1=113-<117; Gr 2=117-<121; Gr 3=121-125; Gr 4>125. Hypocarbia: Gr 1=19-21; Gr 2=15-<19; Gr 3=41-45; Gr 4=>45. Hypercarbia: Gr 1=31-36; Gr 2=37-40; Gr 3=41-45; Gr 4=>45. Hyponatremia: Gr 1=130-132; Gr 2=123-<130; Gr 3=116-<123; Gr 4<116. Hypernatremia: Gr 1=148-<151; Gr 2=151-<158; Gr 3=158-165; Gr 4=>165. Hypokalemia: Gr 1=3-3.4; Gr 2=2.5-<3; Gr 3=2-<2.5; Gr 4=<2. Hyperkalemia: Gr 1=5.6-<6.1; G2=6.1-<6.6; Gr 3=6.6-7; Gr 4=>7. Hypoglycemia: Gr 1=55-64; Gr 2=40-<55; Gr 3=30-< 40; G4=-<30. Hyperglycemia: Gr 1=116-<161; Gr 2=161-<251; Gr 3=251-500; Gr 4>500.|Day 1 of treatment through Week 240|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Participants|||Number
2676514|NCT01438424|Primary|Overall Study: Number of Participants With Normal Pancreatic Enzyme and Renal Function Values at Baseline and Abnormalities in Pancreatic Enzyme and Renal Function Laboratory Test Results at End of Dosing|Amylase: Grade 1=1.10-<1.40*ULN; Grade 2=1.40-< 2.10*ULN; Grade 3=2.10-5.00*ULN; Grade 4=>5.00*ULN. Lipase: Grade 1.1-<1.4*ULN; Grade 2=1.4-<2.1*ULN; Grade 3=2.1-5.0*ULN; Grade 4=>5.0*ULN. Creatinine: Grade 1=1.10-< 1.60*ULN; Grade 2=1.60-<3.10*ULN; Grade 3=3.10-6.00*ULN; Grade 4=>6.00*ULN. Blood urea nitrogen (BUN): Grade 1=1.25-<2.60*ULN; Grade 2=2.60-<5.10*ULN; Grade 3=5.10-10*ULN; Grade 4=>10*ULN. ULN=upper limit of normal.|Day 1 of treatment through Week 240|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Participants|||Number
2676531|NCT01438294|Other Pre-specified|Energy Expenditure|Was measured using a biaxial accelerometer (SenseWearTM Pro activity monitor, USA) (Kuys et al. 2011). The equipment was always used on the upper right limb for the determination of skin temperature, galvanic skin response and movement. Energy expenditure was calculated in metabolic equivalents (METS) and calories per minute. The SenseWear arm bandTM was used during the exercise sessions as a comparative parameter of effort intensity in the VGG and TG. The energy expenditure at rest, medium and maximum effort was the average of all sessions of all children.|baseline and during all training sessions 8 weeks|||||||
2676515|NCT01438424|Primary|Overall Study: Number of Participants With Normal Hematology Values at Baseline and Abnormalities in Hematology Laboratory Test Results Through Week 240|Hemoglobin (g/dL): Grade (Gr) 1=9.5-11.0; Gr 2=8.0-<9.5; Gr 3=6.5-<8.0; Gr 4=<6.5 White blood cells (cells/mm^3): Gr 1=2,500-<4,000; Gr 2=1,000-<2,500; Gr 3=800-<1,000; Gr 4=<800. Neutrophils (cells/mm^3): Gr 1=1000-<1500; Gr 2=750-<1000; Gr 3=500-<750; Gr 4=<500. Platelets (cells/mm^3): Gr 1=75,000-99,000; Gr 2=50,000-<75,000; Gr 3=20,000-<50,000; Gr 4=<20,000. Prothrombin time (seconds): Gr 1=1.01-<1.26*ULN; Gr 2=1.26-<1.51 *ULN; Gr 3=1.51-3*ULN; Gr 4=>3*ULN. INR: Gr 1=1.24-1.5; Gr 2=1.5-2; Gr 3=2-3; Gr 4=>3. INR=international normalized ratio; ULN=upper limit of normal. .|Day 1 of treatment through Week 240|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Participants|||Number
2676516|NCT01438424|Secondary|Week 192: Percentage of Participants With Improvement in Fibrosis (Efficacy Evaluable Cohort)|The Ishak Modification for Hepatic Activity Index (HAI) scores necroinflammatory activity in chronic hepatitis. 0=no fibrosis, 1=fibrosis expansion of some portal areas, 2=fibrosis expansion of most portal areas, 3=fibrosis expansion of most portal areas with occasional bridging, 4=fibrosis expansion of portal areas with marked bridging, 5=incomplete cirrhosis, 6=probable or definite cirrhosis. Higher score=more severe necrosis. Improvement in fibrosis=≥1-point reduction in HAI score. Cohort participants had to have adequate baseline and long-term biopsy samples and baseline Knodell scores ≥2.|Baseline to Week 192|Subset of participants who who had evaluable paired liver biopsy results at Phase 3 study baseline and on their last observed biopsies performed in the current study. (n=number of evaluable participants)|||Percentage of participants||95% Confidence Interval|Number
2676517|NCT01438424|Secondary|Week 192: Percentage of Participants With Histologic Improvement (Efficacy Evaluable Cohort)|The Knodell Histologic Activity Index scores stage of necrosis and grade of inflammation in liver biopsies. Components are necrosis near the portal vein, intralobular degeneration and focal necrosis, portal inflammation, and fibrosis. The 4 components are scored from 1 to 4 and 1 to 10 (necrosis near the portal vein) and combined for a total score, with 22 being the highest possible score. Higher the score for each component=greater liver damage. Histologic improvement=a ≥2-point reduction in total Knodell score and no worsening in fibrosis. Cohort participants had to have adequate baseline and long-term biopsy samples and baseline Knodell necroinflammatory scores ≥2.|Baseline to Week 192|Subset of participants who who had evaluable paired liver biopsy results at Phase 3 study baseline and on their last observed biopsies performed in the current study. (n=number of evaluable participants)|||Percentage of participants||95% Confidence Interval|Number
2676518|NCT01438424|Secondary|Overall Study: Percentage of Participants Who Achieved ALT Normalization|ULN=upper limit of normal. ALT normalization=ALT levels ≤1.0*ULN.|Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
2676519|NCT01438424|Secondary|Overall Study: Mean Alanine Transaminase (ALT) Levels|Observed values.|Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||U/L||Standard Deviation|Mean
2676520|NCT01438424|Secondary|Overall Study: Percentage of Participants With HBeAg Seroconversion|Observed values. Seroconversion=negative HBeAg with detectable anti-HBe antibody.|Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
2676521|NCT01438424|Secondary|Overall Study: Percentage of Participants Who Achieved a Loss of Hepatitis B e Antigen (HBeAg)|Observed values.|Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
2676522|NCT01438424|Secondary|Overall Study: Mean HBV DNA Level by PCR Assay||Study entry to Week 216|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||log10 copies/mL||Standard Deviation|Mean
2676523|NCT01438424|Primary|Overall Study: Number of Participants With Death As Outcome, Any Adverse Event (AE), Grade 3-4 AEs, Serious Adverse Events (SAEs), and Discontinuations Due to AEs|An AE is a new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not be causally related to treatment. An SAE is an unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling. ALT=alanine transaminase; ULN=upper limit of normal.|Continuously from Day 1 through Week 240|All participants who received at least 1 dose of study drug in the current study.|||Participants|||Number
2676524|NCT01438424|Secondary|Overall Study: Percentage of Participants by HBV DNA Category by PCR Assay|Observed values.|Baseline to Week 192|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
2676525|NCT01438424|Secondary|Overall Study: Percentage of Participants With Sustained HBV DNA <10^4 Copies/mL by PCR Assay||Study entry to Week 192|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
2676526|NCT01438424|Secondary|Overall Study: Percentage of Participants With Sustained HBV DNA Level <300 Copies/mL by PCR Assay||Study entry to Week 192|Participants who received at least 1 dose of study drug in the current study. (n=number of evaluable participants)|||Percentage of participants|||Number
2676527|NCT01438307|Secondary|Overall Survival|Assessment will be made in subjects with Stage IV NSCLC who receive Cabazitaxel-SRP6258 after progressing with first line platinum-based chemotherapy.|28 months||||months||95% Confidence Interval|Median
2676528|NCT01438307|Secondary|Number of Patients With Any Graded Adverse Event|Safety will be assessed using the National Cancer Institute Common Toxicity Criteria (Version 4.0) and all adverse events will be recorded prior to each treatment regimen.|Baseline up to 28 months|14 patients in each cohort were included in the toxicity assessment and 13 patients in each cohort in the efficacy assessment.|||Participants|||Count of Participants
2676529|NCT01438307|Secondary|Progression Free Survival|Progression Free Survival is defined from the initiation of treatment until radiological-clinical evidence of progression according to the RECIST (v 1.1).|Baseline up to 28 months||||months||95% Confidence Interval|Median
2676532|NCT01438294|Other Pre-specified|Asthma Control Questionnaire (ACQ6) - Clinical Control of Disease|"Asthma control questionnaire (ACQ) is a standardized toll to assess clinical control in asthmatic patients and consists of 7 questions, 5 related to asthma symptoms, one regarding the use of short- acting ß2 agonists as rescue medication, and one regarding FEV1 before bronchodilator in percent of predicted.~ACQ score is the average these items and ranges from 0 (completely controlled) to 6 (uncontrolled) obtained in a 7 days period. The total points is divided by six to provide the final score ( six questions with range 0 to 6 points, maximal 36 points divided by six maximal 6 and mimimal 0)~The cutoff point for controlled/uncontrolled asthma is 2 points. Patient was classified according ACQ scores into controlled (<0.75), partially controlled (0.75-1.5) and uncontrolled asthma (>1.5). A minimal clinical important difference is 0.5 on a 7-point scale (Juniper et al.2005, Leite et al. 2008 and Ko et al. 2012)."|clinical control week 8||||units on a scale||Inter-Quartile Range|Median
2676533|NCT01438294|Secondary|Pulmonary Function|was performed before and after the inhalation of 400μg of salbutamol (Easy One™, USA), and technical procedures were performed as recommended by ATS/ERS. Predicted normal values were those proposed by Polgar and Promadhat 1971 and a 12% and 200 mL increase in FEV1 from baseline were characterized as a positive response to the bronchodilator) in a climate-controlled room.|baseline and after 8 weeks|||||||
2676534|NCT01438294|Secondary|Body Composition|All participants were evaluated individually, always during the afternoon to avoid circadian changes. Height, weight and abdominal circumference were determined. Tetrapolar bioimpedance was measured using the Biodynamics™ model 310 (Biodynamics Corporation Seattle WA, USA) by positioning the child in the supine position and electrodes in the extremity of the right upper and lower limbs (Goran et al.1993).|baseline and after 8 weeks|||||||
2676535|NCT01438294|Secondary|Treadmil Test (Bruce Protocol)|"A maximal exercise testing was performed in a treadmill using Bruce protocol that has been used to provide information on exercise capacity, physiopathological characteristics during effort, the efficacy of medications and the potential risk for diseases ( Zijp et al. 2010). The test was interrupted when the child reported maximal fatigue or reached the maximum heart rate around 200bpm (Peyer et al. 2011). During the test, blood pressure and peripheral oxygen saturation were quantified and an electrocardiogram was performed. The Borg scale was used to quantify for the sensation of shortness of breath during effort and at rest (Lamb 1995).~Change from baseline in the distance walked on treadmill test will be consider as outcome measure."|8 week distance walked on treadmill test||||meters||Standard Deviation|Mean
2676536|NCT01438294|Primary|Exhaled Nitric Oxide (FeNO) Level|"The measurement of exhaled FeNO level is performed by several commercially available devices, however the equipment NIOX ® (Aerocrine, Sweden) analyzer is the only FDA-approved and Anvisa (Food and Drug Administration) for clinical monitoring of asthma.~The measure will be performed before and after the training program of exercise, or pulmonary rehabilitation, by means of portable equipment NIOX MINO ®."|The FeNO level was performed in week 8||||ppb||Standard Deviation|Mean
2676537|NCT01438229|Other Pre-specified|Cystatin C||24 months||||mg/L||Standard Deviation|Mean
2676538|NCT01438229|Other Pre-specified|Cystatin C||18 months||||mg/L||Standard Deviation|Mean
2676539|NCT01438229|Other Pre-specified|Cystatin C||12 months||||mg/L||Standard Deviation|Mean
2676540|NCT01438229|Other Pre-specified|Cystatin C||6 months||||mg/L||Standard Deviation|Mean
2676541|NCT01438229|Other Pre-specified|Cystatin C||Baseline||||mg/L||Standard Deviation|Mean
2676542|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.~estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|24 months||||mL/min per 1.73m^2||Standard Deviation|Mean
2676543|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.~estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|18 months||||mL/min per 1.73m^2||Standard Deviation|Mean
2676544|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.~estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|12 months||||mL/min per 1.73m^2||Standard Deviation|Mean
2676545|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.~estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|6 months||||mL/min per 1.73m^2||Standard Deviation|Mean
2676546|NCT01438229|Other Pre-specified|Estimated Glomular Filtration Rate|"Calculated using Modifide Diet in Renal Disease formula.~estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)"|Baseline||||mL/min per 1.73m^2||Standard Deviation|Mean
2676547|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||24 months||||mg/g||Standard Deviation|Mean
2676548|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||18 months||||mg/g||Standard Deviation|Mean
2676549|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||12 months||||mg/g||Standard Deviation|Mean
2676550|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||6 months||||mg/g||Standard Deviation|Mean
2676551|NCT01438229|Other Pre-specified|Urine Albumin to Creatinine Ratio||Baseline||||mg/g||Standard Deviation|Mean
2676552|NCT01438229|Other Pre-specified|24hr Ambulatory Diastolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 24 months||||mmHg||Standard Deviation|Mean
2676553|NCT01438229|Other Pre-specified|24hr Ambulatory Diastolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 12 months||||mmHg||Standard Deviation|Mean
2676554|NCT01438229|Other Pre-specified|24hr Ambulatory Diastolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 6 months||||mmHg||Standard Deviation|Mean
2676555|NCT01438229|Other Pre-specified|24hr Ambulatory Systolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 24 months||||mmHg||Standard Deviation|Mean
2676556|NCT01438229|Other Pre-specified|24hr Ambulatory Systolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 12 months||||mmHg||Standard Deviation|Mean
2676557|NCT01438229|Other Pre-specified|24hr Ambulatory Systolic BP Change|Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.|Baseline to 6 months||||mmHg||Standard Deviation|Mean
2676558|NCT01438229|Other Pre-specified|Office Diastolic BP Change||Baseline to 24 months||||mmHg||Standard Deviation|Mean
2676559|NCT01438229|Other Pre-specified|Office Diastolic BP Change||Baseline to 18 months||||mmHg||Standard Deviation|Mean
2676560|NCT01438229|Other Pre-specified|Office Diastolic BP Change||Baseline to 12 months||||mmHg||Standard Deviation|Mean
2676561|NCT01438229|Other Pre-specified|Office Systolic BP Change||Baseline to 24 months||||mmHg||Standard Deviation|Mean
2676562|NCT01438229|Other Pre-specified|Office Systolic BP Change||Baseline to 18 months||||mmHg||Standard Deviation|Mean
2676563|NCT01438229|Other Pre-specified|Office Systolic BP Change||Baseline to 12M||||mmHg||Standard Deviation|Mean
2676564|NCT01438229|Other Pre-specified|Office Diastolic BP Change||Baseline to 6M||||mmHg||Standard Deviation|Mean
2676565|NCT01438229|Primary|Office Systolic Blood Pressure Change||Baseline to 6 months|Subjects with both baseline and 6M follow up office blood pressure measurements|||mmHg||Standard Deviation|Mean
2676566|NCT01438229|Primary|Adverse Events|All device or procedure related adverse events|24 months|All subjects receiving renal artery ablation procedure|||percentage of participants|||Number
2676567|NCT01438177|Secondary|Median Duration of Response of This Regimen|Duration of response is the time from response (CR or PR) until progression of disease or relapse. Responses and progression were evaluated based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006).|up to 2 years|patients who have responded|||months||Full Range|Median
2676568|NCT01438177|Secondary|Percentage of Subjects Who Have Complete Response or Partial Response and Have 2+ or Higher Autophagy||until clinical response (up to 2 years)|Study was terminated prior to collection of this data point.||||||
2676569|NCT01438177|Secondary|Number of Participants With Adverse Events of Grade 3 or Higher|Adverse events reported here were at least possibly related to the protocol therapy.|Treatment period plus 30 days post-treatment|Any patients who started the treatment|||participants|||Number
2676570|NCT01438177|Primary|Response Rate (CR + PR After 2 Cycles)|"Response rate is defined as the percentage of patients who have a complete response (CR) or partial response (PR). Responses were assessed every two cycles of treatment, based on the criteria published by the International Myeloma Working Group (Durie, et al, 2006). Per International Myeloma Working Group response criteria:~CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and < 5% plasma cells in bone marrow PR: > 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to < 200 mg/24 h"|Up to 2 years|Evaluable patients.|||percentage of participants|||Number
2676571|NCT01438151|Primary|Remicade Dose Escalation|At visit 1 and 2, Remicade given at 5mg/kg. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.|2/16/12-3/22/13||||participants|||Number
2676572|NCT01438060|Secondary|Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Treatment Beyond 140 Weeks|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Week 140 to Week 328|Participants in France who completed the 130-week open-label extension phase and continued beyond Week 140 were included in safety sample.|||Participants|||Number
2676573|NCT01438060|Secondary|Participants With Potentially Clinically Significant Laboratory Abnormalities During Extension Phase|Criteria for identifying potentially clinically significant laboratory values were based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products.|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group) were included in the Extension Phase Safety Sample.|||Participants|||Number
2676574|NCT01438060|Secondary|Participants With a Potentially Clinically Significant Electrocardiogram Abnormalities During Extension Phase|Bradycardia:Heart rate ≤50 bpm and ≥15 bpm decrease from baseline; Supraventricular premature beat: ≥2 per 10 seconds and any increase from baseline; 1st degree A-V Block: PR ≥0.20 seconds and increase of ≥0.05 second from baseline; Intraventricular conduction block:QRS ≥0.12 second and increase of ≥0.02 second from baseline; QTcB= ≥450 msec and ≥10% increase from baseline; QTcN =≥450 msec and ≥10% increase from baseline. All other events were not present at baseline but observed during the study|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group) were included in the Extension Phase Safety Sample.|||Participants|||Number
2676626|NCT01437878|Secondary|Change in Oxygen Uptake|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
2676575|NCT01438060|Secondary|Participants With a Potentially Clinically Significant Vital Sign Abnormality During Extension Phase|Systolic BP: increase defined as ≥180 and a ≥20-mmHg increase from baseline (BL); decrease defined as ≤90 and a ≤20mmHg decrease from BL. Diastolic BP: increase defined as ≥105 and a ≥15mmHg decrease from BL, decrease defined as ≤50 and a ≤15mmHg decrease from BL. Heart rate: increase defined as ≥120 and ≥15bpm increase from bBL, decrease defined as ≤50 and ≤15bpm decrease from BL; Weight: increase defined as ≥7% from baseline, decrease defined as ≤7% decrease BL. Criteria for identifying PCS measurements based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group) were included in the Extension Phase Safety Sample.|||Participants|||Number
2676576|NCT01438060|Secondary|Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AE During Extension Phase|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group)were included in the Extension Phase Safety Sample.|||Participants|||Number
2676577|NCT01438060|Secondary|Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events During Extension Phase|Extrapyramidal symptoms (EPS) are various movement disorders such as acute dystonic reactions, pseudoparkinsonism, or akathisia|Week 11 to Week 140|All the 161 participants (80 in placebo and 81 in aripiprazole group)were included in the Extension Phase Safety Sample.|||Participants|||Number
2676578|NCT01438060|Secondary|Change in Barnes Global Clinical Assessment of Akathisia Score During Extension Phase|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|End of Acute Phase (Week 10), Weeks 18,26, 40, 52|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.~Of the 161 participants, 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."|||units on a scale||Standard Error|Mean
2676579|NCT01438060|Secondary|Change in Simpson-Angus Scale (SAS) Total Score During Extension Phase|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50 (lower score=less severe). Negative change scores indicate improvement.|End of Acute Phase (Week 10), Weeks 18,26, 40, 52|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.~Of the 161 participants, 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."|||Units on Scale||Standard Error|Mean
2676580|NCT01438060|Secondary|Change in Abnormal Involuntary Movement Scale (AIMS) Total Score During Extension Phase|"AIMS is a rating scale that was designed to measure involuntary movements (tardive dyskinesia). The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. These items are rated on a five-point scale of severity from 0-4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe).~AIMS Total Score is from 0 to 28. A negative change score signifies improvement."|End of Acute Phase (Week 10), Weeks 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 140|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.~Of the 161 participants (80 in placebo and 81 in aripiprazole group), 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."|||Units on Scale||Standard Error|Mean
2676581|NCT01438060|Secondary|Clinical Global Impression (CGI) Improvement Score During Extension Phase|The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Weeks 12, 14, 18, 22, 26, 30, 34, 40, 46, 52, 68, 84, 100, 116, 132, 140|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values.~Of the 161 participants, 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."|||Units on Scale||Standard Error|Mean
2676582|NCT01438060|Secondary|Change in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score From Baseline During Extension Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 18,26,40,52,68,84,100,116,132,140|"Observed Cases data set, Efficacy Sample. n=participants with both post-baseline and baseline values~Of the 161 participants (80 in placebo and 81 in aripiprazole group), 158 were included in the Extension Phase Efficacy Sample, (3 treated participants had no efficacy measurements)."|||Units on a Scale||Standard Error|Mean
2676627|NCT01437878|Secondary|Change in End Tidal Partial Pressure of Oxygen|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
2676583|NCT01438060|Secondary|Participants With Potentially Clinically Significant Electrocardiogram Abnormalities in Acute Phase|Bradycardia:Heart rate ≤50 bpm and ≥15 bpm decrease from baseline; Supraventricular premature beat: ≥2 per 10 seconds and any increase from baseline; 1st degree A-V Block: PR ≥0.20 seconds and increase of ≥0.05 second from baseline; Intraventricular conduction block:QRS ≥0.12 second and increase of ≥0.02 second from baseline; QTcB= ≥450 msec and ≥10% increase from baseline; QTcN =≥450 msec and ≥10% increase from baseline. All other events were not present at baseline but observed during the study. Inc=increase|Week 1 to Week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication. n=Participants who were evaluated for electrocardiogram|||Participants|||Number
2676584|NCT01438060|Secondary|Participants With Potentially Clinically Significant (PCS) Vital Sign Abnormalities in Acute Phase|Systolic BP: increase defined as ≥180 and a ≥20-mmHg increase from baseline (BL); decrease defined as ≤90 and a ≥20mmHg decrease from BL. Diastolic BP: increase defined as ≥105 and a ≥15mmHg decrease from BL, decrease defined as ≤50 and a ≥15mmHg decrease from BL. Heart rate: increase defined as ≥120 and ≥15bpm increase from BL, decrease defined as ≤50 and ≥15bpm decrease from BL; Weight: increase defined as ≥7% from BL, decrease defined as ≤7% decrease BL. Criteria for identifying PCS measurements are based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products|Week 1 to week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication. n=Participants with values for vital signs|||Participants|||Number
2676585|NCT01438060|Secondary|Participants With Potentially Clinically Significant Laboratory Abnormalities in Acute Phase|Criteria for identifying potentially clinically significant laboratory values were based on guidelines suggested by the FDA Division of Neuropharmacological Drug Products. Normal ranges are local lab data and vary according to the site. M=male, F=female. Criteria for hematocrit also includes a 3 point shift from baseline.|Week 1 to Week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication. n=Participants with values for laboratory findings|||Participants|||Number
2676586|NCT01438060|Secondary|Participants Who Died, Experienced Serious Adverse Events (SAEs), Adverse Events (AEs) or Discontinuations Due to AEs in Acute Phase|AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.|Week 1 to week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication.|||Participants|||Number
2676587|NCT01438060|Secondary|Participants With Extrapyramidal Symptoms (EPS) Related Adverse Events in Acute Phase|Extrapyramidal symptoms (EPS) are various movement disorders such as acute dystonic reactions, pseudoparkinsonism, or akathisia|Week 1 to week 10|Of the 208 randomized participants, one (randomized to aripiprazole) was excluded from the Safety Sample as the participant withdrew consent prior to receiving study medication.|||Participants|||Number
2676588|NCT01438060|Secondary|Change From Baseline in Barnes Global Clinical Assessment of Akathisia in Acute Phase|The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"Observed cases data set, efficacy sample. n=Participants with both post-baseline and baseline measures.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Unit on scale||95% Confidence Interval|Mean
2676589|NCT01438060|Secondary|Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score in Acute Phase|"The Abnormal Involuntary Movement Scale (AIMS) is a rating scale that was designed to measure involuntary movements (tardive dyskinesia). The AIMS test has a total of twelve items rating involuntary movements of various areas of the patient's body. These items are rated on a five-point scale of severity from 0-4. The scale is rated from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe).~AIMS Total Score is from 0 to 28. A negative change score signifies improvement."|Baseline (Day 0), Weeks 2, 4, 8, and 10|"Observed Cased data set, efficacy sample. n=Participants who had both post baseline and baseline values.~Of the 208 randomized participants, 5 were excluded from the efficacy data set: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on scale||95% Confidence Interval|Mean
2676590|NCT01438060|Secondary|Change From Baseline in Simpson-Angus Scale (SAS) Total Score in Acute Phase|The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50.(lower score=less severe). Negative change scores indicate improvement.|Baseline (Day 0), Weeks 2, 4, and 10|"Observed cases data set, Efficacy Sample. n=Participants who had both post baseline and baseline values.~Of the 208 randomized participants, 5 were excluded from the efficacy data set: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on scale||95% Confidence Interval|Mean
2676628|NCT01437878|Secondary|Change in End Tidal Partial Pressure of Carbon Dioxide|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
2676591|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Sleep|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
2676592|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Appetite/Eating Behaviors|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
2676593|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Aberrant Motor Behavior|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
2676594|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Irritability/Lability|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
2676595|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Disinhibition|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
2676596|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Elation/Euphoria|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
2676597|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Apathy/Indifference|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
2676645|NCT01437605|Primary|Number of Participants With Adverse Events Related to Study Treatment|Number of participants with adverse events after receiving one dose of recMAGE-A3 + AS15 ASCI or recMAGEA3 + AS15 ASCI in combination with Poly IC:LC|Beginning of Treatment to End of Follow Up - up to 5 years per participant||||Participants|||Count of Participants
2676598|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Anxiety|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
2676599|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Depression/Dysphoria|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
2676600|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Agitation/Aggression|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
2676601|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Hallucinations|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
2676602|NCT01438060|Secondary|Change From Baseline in NPI Individual Item Scores in Acute Phase: Delusions|The 12 individual items in NPI that quantify behavioral changes in dementia are delusions, hallucinations, agitation, depression, anxiety, apathy, disinhibition, irritability, euphoria, aberrant motor behavior, nighttime behaviors, and appetite. For each behavioral domain there are 4 scores (refer to outcome 1 for the scoring for frequency, severity, total, caregiver distress). Presence of symptoms (0=no, 1=yes) x ratings for frequency and severity yield a total possible score of 0 to 12 for each item. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
2676603|NCT01438060|Secondary|Change From Baseline in Mini Mental State Examination (MMSE) Total Score in Acute Phase|The MMSE is a screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language). It is a 19 item scale, the total score can range from 0 to 30, with a higher score indicating better function. A positive change score indicates improvement from baseline.|Baseline (Day 0), Week 10|"LOCF data set, efficacy sample. n=Participants who had both post baseline and baseline values.~Of the 208 randomized participants, 5 were excluded from the efficacy data set: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on Scale||Standard Error|Mean
2676604|NCT01438060|Secondary|Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score in Acute Phase|"The BPRS is designed to measure clinical change in participants and is used as a global measure of psychopathology. The BPRS includes 18 items with items devoted to hallucinatory behavior, suspiciousness, unusual thought content, etc. BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126.~A negative change score signifies improvement."|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample. n = Participants who had both post baseline and baseline values.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Unit on Scale||95% Confidence Interval|Mean
2676629|NCT01437878|Secondary|Change in Pulmonary Vascular Resistance|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
2676605|NCT01438060|Secondary|CGI Improvement Score in Acute Phase|The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Improvement scale is a 7 point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.|Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample. n = Participants who had both post baseline and baseline values.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on Scale||Standard Error|Mean
2676606|NCT01438060|Secondary|Change From Baseline in Clinical Global Impression (CGI) Severity of Illness Score in Acute Phase|The CGI rating scale, which measures symptom severity, treatment response and the efficacy of treatments, is used in clinical studies on mental disorders. CGI Severity scale is a 7-point scale that requires the clinician to rate the severity of the illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. The assessment is based on severity of mental illness at the time of rating, 0=not assessed, 1=normal, 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; or 7=extremely ill.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2). An additional participant did not have CGI-Severity score and was not included in the analysis"|||Units on Scale||95% Confidence Interval|Mean
2676607|NCT01438060|Secondary|Change From Baseline in NPI Total Caregiver Distress Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The total NPI Caregiver Distress Score is calculated by adding the 12 Caregiver Distress Individual Item Scores, to yield a possible total score of 0 to 60. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
2676608|NCT01438060|Secondary|Change From Baseline in NPI Psychosis Subscale Caregiver Distress Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale:0=not at all distressing to 5=extremely distressing). The NPI Psychosis Subscale Caregiver Distress Score is calculated by adding Individual Item Scores for the domains of Delusions and Hallucinations, to yield a possible total score of 0 to 10. Lower score=less severity. A negative change score from baseline=improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Unit on a Scale||95% Confidence Interval|Mean
2676609|NCT01438060|Secondary|Participants Who Demonstrated a ≥ 50% Decrease From Baseline in the Total NPI Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement.|Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Participants|||Number
2676610|NCT01438060|Secondary|Participants Who Demonstrated a ≥ 50% Decrease From Baseline to Endpoint in the NPI Psychosis Subscale Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.|Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Participants|||Number
2676611|NCT01438060|Secondary|Change From Baseline in NPI Total Score in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale: 1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Total Score is calculated by adding the Individual Item Scores for all 12 domains, to yield a possible NPI Total Score of 0 to 144. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, 8, and 10|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a Scale||95% Confidence Interval|Mean
2676630|NCT01437878|Secondary|Change in Right Ventricular Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
2676612|NCT01438060|Secondary|Change From Baseline in NPI Psychosis Subscale Score Through Week 8 in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Weeks 1, 2, 3, 4, 6, and 8|"LOCF data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on Scale||95% Confidence Interval|Mean
2676613|NCT01438060|Primary|Change From Baseline in Neuropsychiatric Inventory (NPI) Psychosis Subscale Score at Week 10 in Acute Phase|The NPI is a questionnaire that quantifies behavioral changes in dementia. For each of 12 behavioral domains there are 4 scores: Frequency (scale:1=occasionally to 4=very frequently), Severity (scale:1=Mild to 3=Severe), Total (frequency x severity), Caregiver distress (scale: 0=not at all distressing to 5=extremely distressing).The NPI Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual Item Scores, to yield a possible total score of 0 to 24. Lower score=less severity. A negative change score from baseline indicates improvement.|Baseline (Day 0), Week 10|"Last Observation Carried forward (LOCF) data set, efficacy sample.~Of the 208 randomized participants, 5 were excluded from the efficacy data sample: 2 from placebo (Withdrew Consent, Inadequate Caregiver Input.); 3 in aripiprazole group (Withdrew Consent-1, AE-2)"|||Units on a scale||Standard Error|Mean
2676614|NCT01437995|Secondary|Pulmonary Function: Change in FEV1/FVC Ratio|Change in participant's FEV1/FVC ratio calculated as 48 weeks minus baseline.|Baseline and 48 weeks||||ratio||95% Confidence Interval|Median
2676615|NCT01437995|Secondary|Change in Pulmonary Function: FEV1 and FVC|Change in participant's pre-bronchodilator pulmonary function tests (FEV1 and FVC) calculated as 48 weeks minus baseline.|Baseline and 48 weeks||||Liters||95% Confidence Interval|Median
2676616|NCT01437995|Secondary|Rate of Episodes of Poor Asthma Control|Rate of episodes of poor asthma control (EPAC) defined by unscheduled medical care, hospitalization, use of oral corticosteroids and/or increased use of rescue medications and/or decrease of 30% or more in morning peak expiratory flow rate|48 weeks||||Episodes of poor asthma control|||Number
2676617|NCT01437995|Secondary|Pulmonary Function- Change in Peak Expiratory Flow|Change in morning peak expiratory flow rate from the patients' daily diary cards, calculated at 48 weeks minus baseline (randomization)|Baseline and 48 weeks||||Liters per minute||95% Confidence Interval|Median
2676618|NCT01437995|Primary|Treatment Failure|Rate of treatment failures assessed by decline in peak flow or FEV1, increased need for beta agonists, requirement for non-scheduled medical care for asthma symptoms, or prednisone taper.|48 weeks||||participants|||Number
2676619|NCT01437943|Primary|Effect of Aliskiren on Kidney Metabolism|Evaluation of aliskiren on kidney metabolism by P-MR spectroscopy|180 days (completion of treatment)|Only one subject completed study drug and no subjects had completed the 6 month P-MR scan at the time the trial was terminated. Because of this, we were not able to analyze the primary outcome.||||||
2676620|NCT01437878|Secondary|Change in Minute Ventilation|Change from baseline to week 4. Minute ventilation was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
2676621|NCT01437878|Secondary|Change in Tidal Volume|Change from baseline to week 4. Tidal volume was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
2676622|NCT01437878|Secondary|Change in Arterial Oxygen Saturation as Indicated by Pulse Oximetry|Change from baseline to week 4. Arterial oxygen was determined by pulse oximetry during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
2676623|NCT01437878|Secondary|Change in Heart Rate|Change from baseline to week 4. Heart rate was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
2676624|NCT01437878|Secondary|Change in Oxygen Uptake Per Heartbeat|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
2676625|NCT01437878|Secondary|Change in Carbon Dioxide Output|Change from baseline to week 4. Pulmonary gas exchange was measured during incremental and constant work rate exercise testing.|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
2676676|NCT01437124|Primary|Cobalt Chromium Levels|Serum cobalt chromium levels post THR|2 years post THR|metal ion levels|||micrograms/dl||95% Confidence Interval|Mean
2676631|NCT01437878|Secondary|Change in Cardiac Output|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
2676632|NCT01437878|Secondary|Change in Mean Right Atrial Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
2676633|NCT01437878|Secondary|Change in Mean Pulmonary Arterial Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
2676634|NCT01437878|Secondary|Change in Diastolic Pulmonary Arterial Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
2676635|NCT01437878|Secondary|Change in Systolic Pulmonary Arterial Pressure|On Day 1 patients underwent acute hemodynamic testing prior to and immediately after (no more than 15 minutes) the first dose of inhaled iloprost or placebo. All hemodynamic variables were measured using a Swan-Ganz catheter.|15 minutes|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
2676636|NCT01437878|Secondary|Participants With Treatment-emergent Adverse Events|Treatment-emergent adverse events up to 24 hours post-end of treatment (EOT), approximately 4 weeks|Baseline up to 24 hours post-EOT, approximately 4 weeks|Total population|||participants|||Number
2676637|NCT01437878|Primary|Change in Endurance Time|Change from baseline to week 4 in endurance time during constant work rate exercise testing|Baseline to week 4|The study was prematurely terminated as after 1 year it was not possible to identify a suitable number of patients who satisfied the selection criteria. Only 2 patients were randomized prior to the termination of the study, and 1 patient received a single dose of active treatment. Therefore, there are inadequate data to evaluate efficacy.||||||
2676638|NCT01437852|Primary|Percent Area of the StrataGraft Treatment Site Requiring Autografting by Day 28|The percentage of the treatment site area initially covered with StrataGraft tissue that required autograft by day 28 was determined.|28 days|ITT Population - consisted of all participants who received any amount of StrataGraft skin tissue, regardless of follow-up status.|||Percentage of area||Full Range|Median
2676639|NCT01437852|Primary|Number of Participants With Wound Closure of the Treatment Sites at Three Months|Determination of complete wound closure of both treatment sites was evaluated at 3 months.|3 months|Intent-to-Treat (ITT) Population consisted of all participants who received any amount of StrataGraft skin tissue, regardless of follow-up status. Participants with available data were analyzed.|||Participants|||Count of Participants
2676640|NCT01437605|Other Pre-specified|Correlation Between Gene Expression Profile and Treatment Clinical Activity|A potential correlation between gene expression profile and treatment clinical activity (RFS) in both study arms (recMAGE-A3 + AS15 ASCI and recMAGE-A3 + AS15 ASCI in combination with Poly IC:LC).|Beginning of Treatment to End of Follow Up - up to 5 years per participant|Participants not analyzed due to low number of patients accrued to this study before closure for likely futility from other negative trials of MAGE-A3||||||
2676641|NCT01437605|Other Pre-specified|Immunogenicity as Measured by T Cell Responses|Immunogenicity as measured by T cell responses directed against MAGE-A3 antigen.|Beginning of Treatment to End of Follow Up - up to 5 years per participant|Participants not analyzed due to low number of patients accrued to this study before closure for likely futility from other negative trials of MAGE-A3||||||
2676642|NCT01437605|Secondary|Median Overall Survival (OS)|OS defined as the interval from randomization to the date of death, irrespective of the cause of death; patients still alive will be censored at the date of the last assessment. The primary analysis will be based on the adjusted Cox regression model.|At 5 years|Data not collected (likely futility from low numbers enrolled when the protocol was closed to accrual)||||||
2676643|NCT01437605|Secondary|Percentage of Participants With Relapse-Free Survival (RFS)|RFS, defined as the time from randomization to the date of first relapse of melanoma or of death, whichever comes first. Percentage of participants with RFS, assessed up to 2 years is reported|Beginning of Treatment to End of Follow Up - up to 2 years per participant||||percentage of participants||95% Confidence Interval|Number
2676644|NCT01437605|Secondary|Immunogenicity Per Treatment Arm|Laboratory Endpoint: Assessment of the immunogenicity of the two regimens. Serum antibodies (such as Anti-MAGE-A3) seropositivity status (a seropositive patient is a patient whose titre is greater than or equal to the cut-off value) will be the primary immune endpoints assessed. Seropositivity will be assessed at baseline, after 2, 4, 6, 7 and 9 administrations, post-treatment (i.e., at concluding visit) and one year after concluding visit (i.e., at follow-up visit 2).|Beginning of Treatment to End of Follow Up - up to 5 years per participant|Data not collected (likely futility from low numbers enrolled when the protocol was closed to accrual)||||||
2676646|NCT01437540|Secondary|Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline|Potentially clinically significant changes were defined as listed in the table below for QT interval, QTcB, QTcF, QRS interval, PR interval and heart rate (HR)|Up to study Week 56 ± 3 days|Patients with baseline and at least 1 post-baseline assessment value for each parameter|||Percentage of patients|||Number
2676647|NCT01437540|Secondary|Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure|Systolic BP ≥180 mmHg and increase ≥20 mmHg from baseline or ≤90 mmHg and decrease ≥20 mmHg from baseline; Diastolic BP ≥105 mmHg and increase ≥15 mmHg from baseline or ≤50 mmHg and decrease ≥15 mmHg from baseline; Pulse rate ≥ 110 bpm and increase ≥ 15% from baseline or ≤ 50 bpm and decrease ≥15% from baseline|Up to study Week 56 ± 3 days|Patients with baseline and at least 1 post-baseline assessment of vital signs for each parameter|||Percentage of patients|||Number
2676648|NCT01437540|Secondary|Percentage of Patients to Experience Any Potentially Clinically Significant (PCS) Post-baseline Change in Clinical Laboratory Values for Hematology, Chemistry or Urinalysis at the End of the Study|"<0.85 x lower limit of normal (LLN) or > 1.15 upper limit of normal (ULN) for hemoglobin, hematocrit, red blood cell, platelet, white blood cell, neutrophil and lymphocyte counts >1.15 × ULN for eosinophil, basophil and monocyte counts~>1.15 x ULN for aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, total bilirubin, creatinine kinase, lactate dehydrogenase, blood urea nitrogen, creatinine, uric acid, total cholesterol, triglycerides <0.85 x LLN or >1.15 ULN for fasting glucose, calcium, phosphorus, total protein and albumin <0.95 x LLN or >1.05 x ULN for sodium, potassium and chloride~Urinary blood, ketones or pH <0.85 x LLN or > 1.15 ULN"|Up to study Week 52|Patients with available non-potentially clinically significant baseline value and at least one post-baseline assessment|||Percentage of participants|||Number
2676649|NCT01437540|Primary|Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE)|TEAEs were coded Version 16.0 of the Medical Dictionary for Regulatory Activities (MedDRA)|Up to study Week 56 ± 3 days|Safety Population defined as all randomized patients who took at least one dose of double-blind investigational product|||Percentage of participants|||Number
2676650|NCT01437501|Secondary|Levels of Sulforaphane and Its Metabolites at the End of Intervention Period (After 84 Daily Doses)|Micromoles of urinary sulforaphane metabolites excreted over 24 hours after consuming the 84th dose.|Endpoints assessed on urine samples collected at the end of the intervention (day 84 [week 12])||||micromoles||Inter-Quartile Range|Median
2676651|NCT01437501|Primary|Effect of Treatment on Levels of Air Toxics Mercapturic Acids Over Intervention Period|Urinary excretion of benzene mercapturic acid (S-PMA) in 12 hour overnight void at 12 weeks|Endpoints were assessed on urine samples collected at the end of the intervention on week 12.|Analyses were conducted on all urine samples provided by study participants at week 12.|||pmol/mg creatinine||Inter-Quartile Range|Median
2676652|NCT01437488|Secondary|Number of Participants Who Tolerated Cabazitaxel||Up to 30 days after completion of study treatment||||Participants|||Count of Participants
2676653|NCT01437488|Secondary|Progression Free Survival|To determine the progression free survival (PFS) of patients with advanced or recurrent urothelial carcinoma who have previously been treated with a platinum based regimen while on treatment with cabazitaxel. Defined as a 20% increase in the largest diameter of the largest lesion by CT scan.|Every 3 cycles or 63 days||||Participants|||Count of Participants
2676654|NCT01437488|Secondary|Overall Survival|To determine the percentage of patients alive at 12 months from trial entry. Overall survival will be measured from date of randomization to date of death due to any cause.|At 12 months||||Participants|||Count of Participants
2676655|NCT01437488|Primary|Overall Response Rate|To determine the overall response rate of patients who have disease response while on treatment with Cabazitaxel. CT scan will be used to measure tumor pre-treatment and then every 3 cycles (every 63 days)|Every 3 cycles or 63 days||||Participants|||Count of Participants
2676656|NCT01437449|Secondary|Grade 3, 4, and 5 Related Adverse Events (Toxicities)|Related adverse events are considered toxicities. The outcome was assessed as adverse events and serious adverse events (SAEs per 21CFR§312.32) at least Grade 3, and are reported as the number of toxicities by grade (3, 4 or 5), a number without dispersion.|2 years||||Related Adverse Events|||Number
2676657|NCT01437449|Secondary|Overall Survival (OS)|Overall survival (OS) was assessed through 24 months. The outcome is reported as the median time that participants remained alive, with 95% CI.|24 months||||months||95% Confidence Interval|Median
2676658|NCT01437449|Secondary|Progression-free Survival (PFS)|"Progression-free survival (PFS), defined as the duration of time from start of treatment to time of progression or death, was assessed through 24 months, according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. The outcome is reported as the median time that participants remained free of progression, with 95% confidence interval (CI).~Complete Response (CR) = Disappearance of all target lesions~Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions~Overall Response (OR) = CR + PR~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)~Stable disease (SD) = Small changes that do not meet any of the above criteria"|24 months||||months||95% Confidence Interval|Median
2676659|NCT01437449|Primary|Overall Response Rate (ORR)|"Clinical response for each participant will be assessed after 8 weeks of treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Overall response rate (ORR) was assessed as the sum of the number of participants that experience a complete response (CR) or partial response (PR). The outcome is defined and reported as the number of subjects that responded, a number without dispersion. Other response statuses are included. RECIST v1.1 criteria is defined as follows.~Complete Response (CR) = Disappearance of all target lesions~Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions~Overall Response (OR) = CR + PR~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s)~Stable disease (SD) = Small changes that do not meet any of the above criteria"|8 weeks|Response data were not available for all participants.|||participants|||Number
2676792|NCT01436305|Secondary|Total Daily Prescribed Pill Number at Days 28 and 84, and Wks 24, 36, 52, 72, 104 and 156|This is a measure of the total number of pills a participant was prescribed on a given day|Day 28, Day 84, Week 24, Week 36, Week 52, Week 72, Week 104, Week 156|Intent-to-treat with available data|||Number of pills||Standard Deviation|Mean
2676660|NCT01437423|Other Pre-specified|Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™.|The number of participants reporting adverse events by demographic characteristic following a primary series injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis) during the 6 years surveillance period is reported.|Up to 30 days post-primary and booster of vaccination|Adverse events were reported from the Safety Analysis Set.|||Participants|||Number
2676661|NCT01437423|Other Pre-specified|Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.|The number of participants reporting unsolicited adverse events within 30 days following a primary series and booster injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis) during the 6 year surveillance period|Up to 30 days post-primary and booster of TETRAXIM™ vaccination|Unsolicited adverse events were reported from the Safety Analysis Set.|||Participants|||Number
2676662|NCT01437423|Other Pre-specified|Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.|Injection-site reactions: Tenderness, Erythema, and Swelling. Systemic reactions: Fever (Temperature) and Crying abnormal. Grade 3 Injection-site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Grade 3 Systemic reactions: Fever, >39.5˚C; Crying abnormal, >3 hours.|Up to 30 days post-primary and booster vaccination|Solicited adverse events were reported from the Safety Analysis Set.|||Participants|||Number
2676663|NCT01437423|Primary|Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.|The number of participants reporting unexpected adverse events within 30 days following a primary series and booster injection of TETRAXIM™ (Combined vaccine of adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated poliomyelitis)) during 6 year surveillance period.|Up to 30 days post-primary and booster vaccination|Adverse events were reported from the Safety Analysis Set.|||Participants|||Number
2676664|NCT01437397|Secondary|Change From Baseline in St George's Respiratory Questionnaire (SGRQ) Total Score|St George's Respiratory Questionnaire (SGRQ) measures COPD-specific health outcomes and consists of 2 parts with 3 dimension scores (a symptom score and an activity and impacts score). SGRQ total score is the sum of these scores and ranges from 0 (best health status) to 100 (worst health status).|Week 24 of treatment|ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment|||Scores on a scale||Standard Error|Least Squares Mean
2676665|NCT01437397|Secondary|Change in Transition Dyspnea Index (TDI) Focal Score|"The TDI measures the change from baseline in severity of breathlessness in symptomatic patients. The TDI contains a rating for 3 categories (functional impairment, magnitude of task, magnitude of effort).TDI scale ranges from -3 (major deterioration) to +3 (major improvement) including a 0 score to indicate no change. The 3 categories are added to obtain a focal score ranging from -9 (including 0) to +9."|Week 24 of treatment|ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment|||Scores on a scale||Standard Error|Least Squares Mean
2676666|NCT01437397|Primary|Change From Baseline in Morning Trough Forced Expiratory Volume in One Second (FEV1)||Week 24 of treatment|ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment|||Liters||Standard Error|Least Squares Mean
2676667|NCT01437397|Primary|Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)||Week 24 of treatment|ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment|||Liters||Standard Error|Least Squares Mean
2676668|NCT01437319|Primary|Corneal Infiltrate Event- Phase II|The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.|12-Month Follow-up|The analysis population consists of subjects that were enrolled into Phase II and were correctly classified as either repeat Mucin Ball former or Non-repeat Mucin Ball former. Twenty- three subjects had incorrect Mucin ball classification.|||percentage of subjects|||Number
2676669|NCT01437319|Primary|Corneal Infiltrate Events - Phase I|The percentage of Subjects that experienced Corneal Inflammatory Events within their Mucin Ball classification.|1-Month Follow-up|The analysis population consists of subjects that completed all study visits in Phase I without a major protocol deviation and were correctly classified as either repeat Mucin Ball former or Non-repeat Mucin Ball former. Five subjects had incorrect Mucin Ball classification and 8 subjects met study objective.|||percentage of subjects|||Number
2676670|NCT01437267|Secondary|Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination|Solicited local reactions were: erythema, induration, pain/tenderness. Solicited systemic reactions were; lethargy, irritability, vomiting, diarrhoea, loss of appetite (and persistent crying in the older infants and infants age group)|During the 7-day follow-up period after vaccination|Analysis was done on as treated safety population|||participants|||Number
2676671|NCT01437267|Primary|Anti-Vi ELISA GMC||At 6 months after last vaccination|Intention-to-treat analysis set|||ELISA Units/mL||95% Confidence Interval|Geometric Mean
2676672|NCT01437267|Primary|Anti-Vi ELISA Geometric Mean Concentration (GMC)||At 28 days after last vaccination|Intention-to-treat analysis set|||ELISA Units/mL||95% Confidence Interval|Geometric Mean
2676673|NCT01437267|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer||At 6 months after last vaccination as compared to baseline|Intention-to-treat analysis set|||percentage of subjects||95% Confidence Interval|Number
2676674|NCT01437267|Primary|Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer||At 28 days after last vaccination as compared to baseline|Intention-to-treat analysis set, which included all participants who received the vaccination, those in whom at least one post-vaccination blood sample was collected, and those for whom at least one ELISA result was available.|||percentage of subjects||95% Confidence Interval|Number
2676675|NCT01437124|Secondary|Chromosomal Abnormality|Deviation of karyotype from normal 2 years post THR|2 years post THR|24 colour FISH|||% chromosomal abberations||95% Confidence Interval|Mean
2676677|NCT01437111|Secondary|Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26|Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study.|Baseline and Week 26|Per Protocol Population consisted of FAS but excluded participants who had important deviations from protocol or did not complete study on study drug. For analysis, participants in Per Protocol Population were categorized into 3 subgroups by osteoporosis therapy received at baseline: Recent/Current, Other therapy, and Treatment Naïve.|||Percent change||Standard Deviation|Mean
2676678|NCT01437111|Primary|Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26|Serum samples to measure serum 25-hydroxyvitamin D [25(OH)D] will be collected at specific visits during the treatment phase of the study.|Week 26|Full Analysis Set (FAS) consisted of participants who received >=1 dose of study drug; had >=1 post-baseline observation for the analysis endpoint; and had baseline data. For analysis, participants in the FAS were categorized into 3 subgroups by osteoporosis therapy received at baseline: Recent/Current, Other therapy, and Treatment Naïve|||Participants|||Number
2676679|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 36 Months||||Points||Inter-Quartile Range|Median
2676680|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 24 Months||||Points||Inter-Quartile Range|Median
2676681|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 12 months||||Points||Inter-Quartile Range|Median
2676682|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 6 months||||Points||Inter-Quartile Range|Median
2676683|NCT01437098|Secondary|Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)|The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.|Baseline to 30 days|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had Q of L available at this visit were analyzed. Not everyone followed to this visit had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.|||Points||Inter-Quartile Range|Median
2676684|NCT01437098|Secondary|Valve-related Deaths||0 day to 36 months||||prob of freedom from event @ 1095 days|||Number
2676685|NCT01437098|Secondary|Valve-related Deaths||0 day to 24 months||||prob of freedom from event @ 730 days|||Number
2676686|NCT01437098|Secondary|Valve-Related Deaths||0 day to 12 months||||prob of freedom from event @ 365 days|||Number
2676687|NCT01437098|Secondary|Valve-related Deaths||0 day to 6 months||||prob of freedom from event @ 183 days|||Number
2676688|NCT01437098|Secondary|Valve-related Deaths||0 day to 30 days||||prob of freedom from event @ 30 days|||Number
2676689|NCT01437098|Secondary|Repeat Hospitalization||0 day to 36 months||||prob of freedom from event @ 1095 days|||Number
2676690|NCT01437098|Secondary|Repeat Hospitalization||0 day to 24 months||||prob of freedom from event @ 730 days|||Number
2676691|NCT01437098|Secondary|Repeat Hospitalization||0 day to 12 months||||prob of freedom from event @ 365 days|||Number
2676692|NCT01437098|Secondary|Repeat Hospitalization||0 day to 6 months||||prob of freedom from event @ 183 days|||Number
2676693|NCT01437098|Secondary|Repeat Hospitalization||0 day to 30 days||||prob of freedom from event @ 30 days|||Number
2676694|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||36 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.|||percentage of participants|||Number
2676793|NCT01436305|Secondary|Count of Participants With Use of Lipid Lowering Medications at Baseline and Wks 24, 52, 104 and 156|Lipid lowering medications are used in the treatment of high levels of fats (lipids), such as cholesterol in blood|Baseline, Week 24, Week 52, Week 104, Week 156|Intent-to-treat|||Participants|||Count of Participants
2676695|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||24 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had Total AR available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.|||percentage of participants|||Number
2676696|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||12 months||||percentage of participants|||Number
2676697|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||6 months||||percentage of participants|||Number
2676698|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)||30 days||||percentage of participants|||Number
2676699|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||36 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.|||percent||Standard Deviation|Mean
2676700|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||24 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.|||percent||Standard Deviation|Mean
2676701|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||12 months||||percent||Standard Deviation|Mean
2676702|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||6 months||||percent||Standard Deviation|Mean
2676703|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)||30 days||||percent||Standard Deviation|Mean
2676704|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||36 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.|||cm²||Standard Deviation|Mean
2676705|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||24 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had EOA measurement available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.|||cm²||Standard Deviation|Mean
2676706|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||12 months||||cm²||Standard Deviation|Mean
2676707|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||6 months||||cm²||Standard Deviation|Mean
2676708|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)||30 days||||cm²||Standard Deviation|Mean
2676709|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||36 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.|||mmHg||Standard Deviation|Mean
2676710|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||24 months|The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had mean gradients available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.|||mmHg||Standard Deviation|Mean
2676711|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||12 months||||mmHg||Standard Deviation|Mean
2676712|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance- Mean Gradient||6 months||||mmHg||Standard Deviation|Mean
2676713|NCT01437098|Secondary|Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient||30 days||||mmHg||Standard Deviation|Mean
2676714|NCT01437098|Secondary|Procedural Success, Defined as Device Success and Absence of In-hospital MACCE.||after procedure or discharge||||percentage of participants|||Number
2676715|NCT01437098|Secondary|Device Success as Defined in the Description.|"successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system~correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function)~Intended performance of the prosthetic valve (aortic valve area >1.2 cm² (by echocardiography using the continuity equation) and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/sec, without moderate or severe prosthetic valve AR)~Only one valve implanted in the proper anatomical location"|after procedure or discharge|The AT cohort that went through an index procedure were analyzed for Device Success. Also, all components that went into the success measures had to be non-missing. Therefore n=53.|||percentage of participants|||Number
2676716|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~all-cause death~myocardial infarction (MI)~all stroke, and~reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 36 months|The Kaplan-Meier Method was used to calculate the number.|||prob of freedom from event at 1095 days|||Number
2676717|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~all-cause death~myocardial infarction (MI)~all stroke, and~reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 24 months|The Kaplan-Meier Method was used to calculate the number.|||prob of freedom from event at 730 days|||Number
2676718|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~all-cause death~myocardial infarction (MI)~all stroke, and~reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 12 months|The Kaplan-Meier Method was used to calculate the number.|||prob of freedom from event @ 365 days|||Number
2676719|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~all-cause death~myocardial infarction (MI)~all stroke, and~reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 6 months|The Kaplan-Meier Method was used to calculate the number.|||prob of freedom from event @ 183 days|||Number
2676720|NCT01437098|Secondary|Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)|"MACCE is defined as a composite of:~all-cause death~myocardial infarction (MI)~all stroke, and~reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)"|0 day to 30 days|The Kaplan-Meier Method was used to calculate the number.|||prob of freedom from event @ 30 days|||Number
2676721|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.~Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.~Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|36 Months||||percentage of participants|||Number
2676722|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.~Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.~Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|24 Months||||percentage of participants|||Number
2676723|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.~Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.~Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|12 Months||||percentage of participants|||Number
2676724|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.~Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|6 months||||percentage of participants|||Number
2676725|NCT01437098|Secondary|NYHA Classification Over Time|"NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.~Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.~Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased."|30 days|NYHA denominators included deaths (n=2). Taken deaths out, you have n=51 at 30 days.|||percentage of participants|||Number
2676726|NCT01437098|Primary|Composite Success of Improvement in New York Heart Association (NYHA) Class and a Performance Goal for Effective Orifice Area (EOA).|The primary endpoint was defined as the proportion of implanted subjects with improvement of at least 1 NYHA class from baseline to 6 months and EOA greater than 1.2 cm² at 6 months.|baseline and 6 months|All subjects implanted with the MDT-2111 device.|||percentage of participants|||Number
2676727|NCT01436799|Primary|Regional Cerebral Oxygen Satuation (rSO2)|definitive values of regional cerebral oxygen saturation(rSO2,%) values are described as mean (SD)|1, 3, 5, 7, and 9 min after the beach chair position|A power analysis was calculated based on a previous study.14 In each group, 16 patients were needed to detect a mean intergroup difference of 5% in the rSO2 value with a power of 80% and a type I error of 0.05. To compensate for a dropout rate of 20%, 40 patients were included in this study.|||percentage of rSO2 (%)||Standard Deviation|Mean
2676728|NCT01436643|Primary|Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death|"In this analysis patients with all (serious and non-serious) adverse events, and death were reported.~See Safety Section."|21 weeks|The safety set was used for analysis, which consists of 54 patients, of whom 2 patients did not start treatment with any antidepressant|||Participants|||Number
2676729|NCT01436526|Secondary|Half-life Associated With the Terminal Slope (t½)|Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis|||hr||Geometric Coefficient of Variation|Geometric Mean
2676730|NCT01436526|Secondary|Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)|Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis|||hr||Full Range|Median
2676731|NCT01436526|Secondary|Mean Residence Time (MRT)|The mean residence time is the average time that the molecules introduced into the body stay in the body.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis|||hr||Geometric Coefficient of Variation|Geometric Mean
2676732|NCT01436526|Secondary|Maximum Observed Drug Concentration in Plasma After Single Dose Administration Divided by Dose Per kg Body Weight (Cmax, Norm)|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; Cmax,norm is defined as Cmax divided by dose (mg) per kg body weight.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis|||kg/L||Geometric Coefficient of Variation|Geometric Mean
2676733|NCT01436526|Secondary|Area Under the Plasma Concentration Versus Time Curve Divided by Dose Per kg Body Weight (AUCnorm)|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; AUCnorm is defined as AUC divided by dose per kg body weight.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis|||kg*hr/L||Geometric Coefficient of Variation|Geometric Mean
2676734|NCT01436526|Primary|Maximum Observed Drug Concentration in Plasma After Single Dose Administration (Cmax) Incl. Bioequivalence (BE) Evaluation|Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis|||µg/L||Geometric Coefficient of Variation|Geometric Mean
2676735|NCT01436526|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tn)] Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; [AUC (0-tn)] is defined as AUC from time 0 to the last data point above the Lower Limit of Quantification.|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis|||µg*hr/L||Geometric Coefficient of Variation|Geometric Mean
2676736|NCT01436526|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity After Single Dose (AUC) Incl. Bioequivalence (BE) Evaluation|The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample (AUC is defined as area under the concentration vs. time curve from zero to infinity after single (first) dose).|0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration|N=26 valid for pharmacokinetic analysis|||µg*hr/L||Geometric Coefficient of Variation|Geometric Mean
2676737|NCT01436500|Secondary|Change in 24-hour Urine Volume|The volume of urine collected in a 24-hour post-treatment period minus the volume collected in a 24-hour pre-treatment period.|Baseline to Hour 96|Data were missing for the post-treatment urine volume measurements in 9 of 42 ifetroban patients and 3 of 13 placebo patients so they were excluded from the analysis.|||mL||Standard Deviation|Mean
2676738|NCT01436500|Secondary|The Percentage of Patients Achieving a Reduction of Creatinine Clearance to Below Baseline on Two Consecutive Daily Measurements||Day 0 to Day 5||||percentage of participants|||Number
2676739|NCT01436500|Secondary|Percentage of Patients Achieving a Treatment-period Serum Creatinine Reduction Below 1.5 mg/dL||Day 0 through Day 5||||percentage of participants|||Number
2676740|NCT01436500|Secondary|Safety: Day 28 Mortality||28 days||||percentage of participants|||Number
2676770|NCT01436370|Secondary|Number of Participants Reporting Solicited Quantitative Local Injection Site Reactions|Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days after vaccination (Day 0-7). If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they reported experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.|Day 0 to Day 7|The analysis population includes all participants enrolled and vaccinated in the study.|||participants|||Number
2676741|NCT01436500|Primary|Pharmacokinetic Parameters (Concentration) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment|Plasma concentrations of ifetroban and it's major active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters.|3 days|Patients from which a full series of plasma samples were obtained from baseline through Hour 72 were included in the calculations of the PK parameters. Where the number of participants analyzed in an arm is lower than the number exposed for that arm, the patients with missing data did not contribute to the calculation of the PK parameters.|||ng/mL||Standard Deviation|Mean
2676742|NCT01436500|Primary|Pharmacokinetic Parameters (Exposure) of Ifetroban and Ifetroban Acylglucuronide After Three Days of Treatment|Plasma concentrations of ifetroban and its primary active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters.|3 days|Patients from which a full series of plasma samples were obtained from baseline through Hour 72 were included in the calculations of the PK parameters. Where the number of participants analyzed in an arm is lower than the number exposed for that arm, the patients with missing data did not contribute to the calculation of the PK parameters.|||ng*hr/mL||Standard Deviation|Mean
2676743|NCT01436500|Primary|Half-life (T-1/2) of Ifetroban and Ifetroban Acylglucuronide|Plasma concentrations of ifetroban and its major active metabolite were measured at Baseline and Study Hours 1, 2, 4, 8, 12, 24, 48, 49, 50, 52, 56, 60, and 72 to determine the Pharmacokinetic parameters.|3 days|Patients from which a full series of plasma samples were obtained from baseline through Hour 72 were included in the calculations of the PK parameters. Where the number of participants analyzed in an arm is lower than the number exposed for that arm, the patients with missing data did not contribute to the calculation of the PK parameters.|||hours||Standard Deviation|Mean
2676744|NCT01436435|Secondary|Major Adverse Events (MAE)|Number of Major Adverse Events as defined by amputation, death, Target Lesion Revascularization, Target Vessel Revascularization, Myocardial Infarction or angiographic distal embolization that requires a separate intervention or hospitalization through 30 days|30 days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.|||Major Adverse Events|||Number
2676745|NCT01436435|Secondary|Ankle-Brachial Index (ABI)|Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.|12 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 64 participants were not evaluable.|||percentage of patients|||Number
2676746|NCT01436435|Secondary|Ankle-Brachial Index (ABI)|Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.|6 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 51 participants were not evaluable.|||percentage of patients|||Number
2676747|NCT01436435|Secondary|Ankle-Brachial Index (ABI)|Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.|30 days|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.|||percentage of patients|||Number
2676748|NCT01436435|Secondary|Procedural Success|Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy|Index Procedure|Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint|||percentage of patients|||Number
2676749|NCT01436435|Primary|Binary Restenosis|Percentage of patients with binary restenosis at 12 months as defined by duplex ultrasound derived systolic velocity ratio >2.5. Binary restenosis will be measured by duplex ultrasound technology.|12 months|Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 184 participants were not evaluable.|||percentage of patients|||Number
2676750|NCT01436396|Secondary|Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following Any and Each Injection With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo|Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: >=50 millimeter (mm). Grade 3 Solicited systemic reactions: Fever: >39.5°celsius; Vomiting: >= episodes per 24 hours or requiring parenteral hydration; Crying abnormal: >3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses >=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable. Solicited Injection site reaction were reported separately for Stamaril®, CYD and placebo vaccine.|Day 0 up to 14 days post any Inj., Post Inj. 1, Post Inj. 2 and Post Inj. 3|Analysis was performed on Safety analysis set. Here, ‘number analyzed’ = participants with available data for each specified category. “0” in “number analyzed” field= none of the participants were evaluable since participants did not received CYD dengue vaccine as Injection 1 (Placebo group) or Placebo at any time point (CYD dengue vaccine group).|||Percentage of participants|||Number
2676751|NCT01436396|Secondary|Percentage of FV Non-immune (Naïve) Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With the Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo|Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV non-immune participants at baseline were defined as those participants with <10 (1/dil) for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus.|Pre-Injection 1 and 28 days Post-Injections 2 and 3|Analysis was performed on Full analysis set for dengue immunogenicity. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2676752|NCT01436396|Secondary|Percentage of FV-immune Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo|Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV-immune participants at baseline were defined as those participants with >= 10 (1/dil) for at least 1 serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strain or for YF virus.|Pre-Injection 1 and 28 days Post-Injections 2 and 3|Analysis was performed on Full analysis set for dengue immunogenicity. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||percentage of participants|||Number
2676753|NCT01436396|Secondary|GMTs of Dengue Virus Antibodies of FV-Non Immune (Naïve) Participants Following Vaccination With YF Vaccine Non Immune (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo|GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV-non-immune participants at baseline were defined as those participants with <10 (1/dil) for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus.|Pre-Injection 1 and 28 days Post-Injections 2 and 3|Analysis was performed on Full analysis set for dengue immunogenicity. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2676754|NCT01436396|Secondary|GMTs of Dengue Virus Antibodies of FV Immune Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo|GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. FV immune participants at baseline were defined as those participants with >= 10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for YF virus.|Pre-Injection 1 and 28 days Post-Injections 2 and 3|Analysis was performed on Full analysis set for dengue immunogenicity. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2676755|NCT01436396|Secondary|Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against at Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strains After YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo|Neutralizing antibodies against at least 1, 2, 3, or 4 serotypes (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay.|Pre-Injection 1 and 28 days Post-Injections 2 and 3|Analysis was performed Full analysis set for dengue immunogenicity. Here, ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2676756|NCT01436396|Secondary|Percentage of Participants With Antibody Titer >= 10 (1/Dil) Against Each Serotype With Parental Dengue Virus Strains After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo|Neutralizing antibodies against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay. Seroconversion was defined as antibody titers >= 10 (1/dil) against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains.|Pre-Injection 1 and 28-days Post-Injections 2 and 3|Analysis was performed Full analysis set for dengue immunogenicity. Here, ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2676757|NCT01436396|Secondary|GMTRs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo|GMTRs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue PRNT assay.|Pre-Injection 1 and 28-days Post-Injections 2 and 3|Analysis was performed on Full analysis set for dengue immunogenicity. Here, ‘number analyzed’ = participants with available data for each specified category.|||Titer ratios||95% Confidence Interval|Geometric Mean
2676758|NCT01436396|Secondary|GMTs of Dengue Virus Antibodies Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo|GMTs against each serotype (Serotype 1, 2, 3 and 4) with the parental dengue virus strains were assessed using a dengue plaque reduction neutralization test (PRNT) assay.|Pre-Injection 1 and 28-days Post-Injections 2 and 3|Analysis performed on Full analysis set for dengue immunogenicity which included participants who received at least 1dose of CYD dengue vaccine/placebo, had at least 1 blood sample withdrawn and valid post vaccination test results for at least 1 dengue serotype. Here,‘number analyzed’ =participants with available data for each specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2676759|NCT01436396|Secondary|Percentage of All Participants With YF Antibody Titers of >=10 (1/Dil) Before and After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo|Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies >=10 (1/dil) regardless of the flavivirus status of participants at baseline.|Pre-Injection 1 and 28-days Post-Injection 1|Analysis was performed on Full analysis set. Here, ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2676760|NCT01436396|Secondary|Geometric Mean Titer Ratios (GMTRs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo|GMTs ratios against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay.|Pre-Injection 1 and 28- days Post-Injection 1|"Analysis was performed on Full analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure."|||Ratio||95% Confidence Interval|Geometric Mean
2676761|NCT01436396|Secondary|Geometric Mean Titers (GMTs) of YF Antibodies in All Participants Following Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo|GMTs against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay.|Pre-Injection 1 and 28-days Post-Injection 1|Analysis was performed on Full analysis set. Here, ‘number analyzed’ = participants with available data for each specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2676762|NCT01436396|Secondary|Percentage of All Participants With Seroconversion Against YF Antigen After Vaccination With YF Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo|Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies >= 10 (1/dil) in participants YF-seronegative at baseline or 4-fold increase from pre- to post-YF antibody titers in participants YF-seropositive at baseline.|28 days Post-Injection 1|Analysis performed on Full analysis set included participants who received at least co-administration of Stamaril® vaccine with either 1st dose of CYD dengue vaccine or placebo, had blood sample post-Stamaril® vaccination drawn and a valid test result. Here, ‘overall number of participants analyzed’=participants evaluable for this outcome measure.|||Percentage of participants|||Number
2676763|NCT01436396|Primary|Percentage of Flavi Virus (FV) Non-immune Participants With Seroconversion Against YF Antigen After Vaccination With Yellow Fever (YF) Vaccine (Stamaril®) Concomitantly With Either CYD Dengue Vaccine or a Placebo|Neutralizing antibodies against YF were assessed using a YF virus plaque reduction neutralization test (YF PRNT50) assay. Seroconversion was defined as YF antibodies >=10 (1/dilution [dil]) in flavivirus non-immune participants (defined as those with YF antibodies <10 [1/dil] for all serotypes (Serotype 1, 2, 3 and 4) with parental dengue virus strains and for YF virus).|28 days Post-Injection 1|Analysis was performed on Per-Protocol analysis set which included all participants who had no protocol deviations. Per-Protocol analysis set was defined for the Stamaril® vaccine immune response.|||Percentage of participants|||Number
2676764|NCT01436370|Secondary|Number of Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from all participants prior to vaccination and at the Days 7, 21 and 180 follow up visits for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 7, 21 and 180 following immunization|The analysis population includes all subjects enrolled and vaccinated with the 2012-2013 vaccines who had blood collected at the visit. One RA Participant, Standard Dose and one Healthy Control, High Dose recipient are not included at Day 180 because the participant was out of window and lost to follow-up, respectively.|||participants|||Number
2676765|NCT01436370|Secondary|Number of Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7, 21 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from all participants prior to vaccination and at the Days 7, 21 and 180 follow up visits for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 7, 21 and 180 following immunization|The analysis population includes all subjects enrolled and vaccinated with the 2011-2012 vaccines.|||participants|||Number
2676766|NCT01436370|Secondary|Number of RA Participants With a Worsening Rheumatoid Arthritis Status During the Course of the Study, Based on the RAPID3 Score From the NP2 Questionnaire|The RAPID 3 score is an index of the three patient-reported measures from the Multi-Dimensional Health Assessment Questionnaire (MDHAQ) R808 and serves as an assessment of patient status for those with rheumatoid arthritis. The score consists of the cumulative total of the Function (FN), Pain (PN), and Patient Global (PTGL) values. The severity of the RAPID 3 score is categorized as: >12=High Severity; 6.1-12=Moderate Severity; 3.1-6=Low Severity; and ≤3=Remission. The NP2 questionnaire was completed by RA participants at all clinic visits. Scores at Days 7, 21 and 180 were compared to Day 0 to determine worsening, defined as moving from the baseline category to a more severe category.|Day 0 to Days 7, 21 and 180|All RA participants are included in the analysis population for this outcome measure.|||participants|||Number
2676767|NCT01436370|Secondary|Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from RA participants prior to vaccination and at the Days 7 and 180 follow up visits for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 7 and 180 following immunization|The analysis population includes RA participants enrolled and vaccinated with the 2012-2013 vaccines who had blood collected at the visit. One RA Participant, Standard Dose recipient is not included at Day 180 because the participant was out of window.|||participants|||Number
2676768|NCT01436370|Secondary|Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Days 7 and 180 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from RA participants prior to vaccination and at the Days 7 and 180 follow up visits for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Days 7 and 180 following immunization|The analysis population includes all RA subjects enrolled and vaccinated with the 2011-2012 vaccines.|||participants|||Number
2676769|NCT01436370|Primary|Number of RA Participants in the 2012-2013 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from RA participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with 2012-2013 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 following immunization|The analysis population includes all RA participants enrolled and vaccinated with the 2012-2013 vaccines.|||participants|||Number
2676771|NCT01436370|Secondary|Number of Participants Reporting Solicited Local Injection Site Reactions Based on a Functional Grading Scale|Participants maintained a memory aid to record daily the occurrence of local injection site reactions of pain, tenderness, redness, and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0 to Day 7|The analysis population includes all participants enrolled and vaccinated in the study.|||participants|||Number
2676772|NCT01436370|Secondary|Number of Participants Reporting Fever|Participants were provided with a thermometer and a memory aid on which to record daily oral temperatures for 8 days after vaccination (Day 0-7). The protocol defined fever as oral temperature of 38.0 degrees Celsius or higher. Participants are counted as experiencing fever if they reported oral temperatures of 38.0 degrees Celsius or higher on any of the 8 days.|Day 0 to Day 7|The analysis population includes all participants enrolled and vaccinated in the study.|||participants|||Number
2676773|NCT01436370|Secondary|Number of Participants Reporting Solicited Systemic Symptoms Based on a Functional Grading Scale|Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, shivering, and asthenia for 8 days after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.|Day 0 to Day 7|The analysis population includes all participants enrolled and vaccinated in the study.|||participants|||Number
2676774|NCT01436370|Secondary|Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2012-2013 Season|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 7, 21 and 180 days following vaccination. The HAI assay was conducted with the three antigens in the 2012-2013 seasonal inactivated TIV. Within each 2012-2013 study arm, geometric mean titers and 95% confidence intervals were calculated for each antigen separately.|Days 0, 7, 21 and 180|The analysis population includes all participants enrolled and vaccinated with the 2012-2013 vaccines who had blood collected at the visit. One RA Participant, Standard Dose and one Healthy Control, High Dose recipient are not included at Day 180 because the participant was out of window and lost to follow-up, respectively.|||titers||95% Confidence Interval|Geometric Mean
2676775|NCT01436370|Secondary|Geometric Mean Titers (GMT) for Each of the Specific Influenza Strains Included in Vaccine Received by Participants in the 2011-2012 Season|Blood was collected for HAI assay at Day 0 prior to vaccination and again at 7, 21 and 180 days following vaccination. The HAI assay was conducted with the three antigens in the 2011-2012 seasonal inactivated TIV. Within each 2011-2012 study arm, geometric mean titers and 95% confidence intervals were calculated for each antigen separately.|Days 0, 7, 21 and 180||||titers||95% Confidence Interval|Geometric Mean
2676776|NCT01436370|Secondary|Number of Participants Reporting Vaccine-related Serious Adverse Events (SAEs) Throughout the Course of the Study.|Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnosis.|Day 0 to Day 180|The analysis population includes all participants enrolled and vaccinated in the study.|||participants|||Number
2676777|NCT01436370|Primary|Number of RA Participants in the 2011-2012 Season Who Achieved Seroconversion at Day 21 Against Each of the 3 Specific Influenza Strains in Vaccine the Participant Received|Blood was collected from RA participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with 2011-2012 seasonal influenza vaccine strains virus as the assay antigens. A participant met the threshold of seroconversion if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.|Day 0 prior to and Day 21 following immunization|The analysis population includes all RA participants enrolled and vaccinated with the 2011-2012 vaccines.|||participants|||Number
2676778|NCT01436357|Secondary|Number of Participants With Positive Cell Mediated Immune Response|Cell mediated immune response was measured by interferon gamma (IFN-gamma) production by T-cells against each of the six HCV genotype 1b peptide pools in the vaccine. Positivity was defined as i) more than 48 spot forming cells per million PBMC; and ii) at least three times the mean background spots per million PBMC found in ELISpot wells containing cells and peptide diluent (DMSO). A participant was considered a responder if a positive response to at least one in 6 mixtures (pools) of peptides was detected.|Within 14 days after the last vaccination (Day 56)|The population for this outcome included all participants who received both vaccinations and had immunogenicity data available. Participants are analyzed as treated. Data collected post-HCV infection were excluded from this analysis.|||Participants|||Count of Participants
2676779|NCT01436357|Primary|Number of Participants With Severe Local and/or Systemic Solicited Reactogenicity Signs and Symptoms in the 8 Days (Day 0-7) After Second Vaccination|"Participants recorded temperature and the presence and intensity of post-vaccination reactogenicity events daily on an 8-day memory aid. Local solicited reactogenicity events included pain, tenderness, erythema, induration and warmth at the injection site. Systemic solicited reactogenicity events included fever, chills, arthralgia/joint pain, malaise/fatigue, myalgia/body aches, headache, nausea, vomiting, abdominal pain. Severe was defined as events interrupt a subject's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually incapacitating. Measured erythema and induration of >50 mm and oral temperature >40.0 degrees Celsius were considered severe."|7 days after second vaccination|The safety analysis population includes all participants receiving the vaccination for whom data were available. Participants are analyzed as treated.|||Participants|||Count of Participants
2676791|NCT01436305|Secondary|Number of Events of Death or Graft Loss|This measure counts deaths and graft loss occurring at any point post transplantation. Graft loss is defined as need for dialysis for greater than 30 days duration, allograft nephrectomy, or retransplantation.|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Events|||Number
2676780|NCT01436357|Primary|Occurrence of Vaccine-related Serious Adverse Events (SAEs) From the Time of First Vaccination Through the Entire Study Period|The occurrence of SAEs was assessed at every study visit. The occurrence of SAEs may also have come to the attention of the investigator by secondary contacts of the participant when they did not present for study visits. Relationship to vaccine was assessed by the site investigator.|Day 0 to 29 months|The safety analysis population excludes 1 participant who was not vaccinated. Participants are analyzed as treated.|||Participants|||Count of Participants
2676781|NCT01436357|Primary|Number of Participants With Severe Local and/or Systemic Solicited Reactogenicity Signs and Symptoms in the 8 Days (Day 0-7) After First Vaccination|"Participants recorded temperature and the presence and intensity of post-vaccination reactogenicity events daily on an 8-day memory aid. Local solicited reactogenicity events included pain, tenderness, erythema, induration and warmth at the injection site. Systemic solicited reactogenicity events included fever, chills, arthralgia/joint pain, malaise/fatigue, myalgia/body aches, headache, nausea, vomiting, abdominal pain. Severe was defined as events interrupt a subject's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually incapacitating. Measured erythema and induration of >50 mm and oral temperature >40.0 degrees Celsius were considered severe."|7 days after first vaccination|The safety analysis population includes all participants receiving the vaccination for whom data were available. Participants are analyzed as treated.|||Participants|||Count of Participants
2676782|NCT01436357|Primary|Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) at 1 Month After Second Vaccination|Blood was collected at baseline and 1 month after each vaccination for assessment of alanine transferase (ALT) (SGPT), creatinine, hemoglobin, platelets, and white blood cells (WBC). A laboratory AE was defined for ALT as greater than 1.25 times the upper limit of normal. A laboratory AE was defined for creatinine as greater than or equal to 1.2 times the upper limit of normal (as appropriate for age and sex). A laboratory AE was defined for hemoglobin as less that or equal to 12.4 g/dl for males and less than or equal to 10.8 g/dl for females. A laboratory AE was defined for platelets as less than or equal to 117,000 per cumm. A laboratory AE was defined for WBC as less than or equal to 2.9 thou/mcl or greater than or equal to 11.9 thou/mcl.|1 month after second vaccination|The safety analysis population includes all participants with blood collected at the timepoint summarized. Participants are analyzed as treated.|||Participants|||Count of Participants
2676783|NCT01436357|Primary|Number of Participants With Clinical Safety Laboratory Adverse Events (AEs) at 1 Month After First Vaccination|Blood was collected at baseline and 1 month after each vaccination for assessment of alanine transferase (ALT) (SGPT), creatinine, hemoglobin, platelets, and white blood cells (WBC). A laboratory AE was defined for ALT as greater than 1.25 times the upper limit of normal. A laboratory AE was defined for creatinine as greater than or equal to 1.2 times the upper limit of normal (as appropriate for age and sex). A laboratory AE was defined for hemoglobin as less that or equal to 12.4 g/dl for males and less than or equal to 10.8 g/dl for females. A laboratory AE was defined for platelets as less than or equal to 117,000 per cumm. A laboratory AE was defined for WBC as less than or equal to 2.9 thou/mcl or greater than or equal to 11.9 thou/mcl.|1 month after first vaccination|The safety analysis population includes all participants with blood collected at the timepoint summarized. Participants are analyzed as treated.|||Participants|||Count of Participants
2676784|NCT01436357|Primary|Number of Participants With Chronic Hepatitis C Virus (HCV) Infection at 6 Months|Chronic hepatitis C virus (HCV) infection was defined by persistent viremia over a period of 6 months after initial detection of primary infection.|6 months|All randomized are included as treated (one participant randomized to placebo received vaccine) with the following censoring criteria applied: did not receive both vaccinations, HCV infected at baseline, did not have sufficient follow-up to be evaluable for efficacy, or had major protocol deviations compromising the assessment of vaccine efficacy.|||Participants|||Count of Participants
2676785|NCT01436305|Secondary|Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90mm Hg Within 24 Hours of Onset of Transplant Procedure|Temperature of >39 degrees Celsius would be an indication of fever most often in response to an infection or illness. Systolic blood pressure <90mm Hg would be an indication of low blood pressure.|24 hours after transplantation|Intent-to-treat|||Participants|||Count of Participants
2676786|NCT01436305|Secondary|Count of Participants With EBV Infection as Reported on the Case Report Form as Adverse Events|"Viral infections following renal transplantation is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during this study using participant blood samples.~Acronym: Epstein-Barr virus (EBV)"|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Participants|||Count of Participants
2676787|NCT01436305|Secondary|Count of Participants With BKV and CMV Viremia (Local Center Monitoring) Reported as Adverse Events|"Viral infections following renal transplantation is significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during this study using participant blood samples.~Acronyms: BK Polyoma Virus (BKV); Cytomegalovirus (CMV)."|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Participants|||Count of Participants
2676788|NCT01436305|Secondary|Count of Participants With Infections Requiring Hospitalization or Systemic Therapy Reported as Serious Adverse Events|Infections of certain types (i.e., excluding those identified in the protocol as occurring commonly in this study population) were required to be reported as a serious adverse event if they required either inpatient hospitalization of prolongation of a current hospitalization.|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Participants|||Count of Participants
2676789|NCT01436305|Secondary|Number of All Adverse Events (AEs) and Serious Adverse Events (SAEs)|Adverse events were collected systematically from enrollment through last study visit. Displayed below are counts of all adverse events per treatment group (including both serious and non-serious adverse events). Separately counts of all adverse events determined to be serious are displayed per treatment group. More detail about adverse events for this trial is displayed in the 'Adverse Event' section.|Enrollment through last study visit (up to week 156)|Intent-to-treat|||Events|||Number
2676790|NCT01436305|Secondary|Count of Participants With Rejection|The number of participants who were treated by their local physician for any type of rejection including, but not limited to cellular rejection and antibody- mediated rejection of the transplanted kidney regardless of the presence of a biopsy.|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Participants|||Count of Participants
2676794|NCT01436305|Secondary|Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156|"A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are detailed below.~Total cholesterol: 75-169 mg/dL if age ≤ 20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease~LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease~HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease~Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease~Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease"|Baseline, Week 24, Week 52, Week 104, Week 156|Intent-to-treat|||mg/dL||Standard Deviation|Mean
2676795|NCT01436305|Secondary|Count of Participants With Use of Anti-hypertensive Medications at Wk 52|Anti-hypertensive medications are a class of drugs that are used to treat hypertension. The medications seek to prevent the complications of high blood pressure, such as stoke and myocardial infarction.|Week 52|Intent-to-treat with available data at Week 52|||Participants|||Count of Participants
2676796|NCT01436305|Secondary|Standardized Blood Pressure Measurement at Wk 52|A blood pressure measurement consists of two numbers: the systolic and diastolic pressures. Systolic pressure measures the pressure in blood vessels when the heart beats. Diastolic pressure measures the pressure in blood vessels between beats of the heart. Systolic measures of <120 and diastolic measures of <80 are considered normal. Systolic measures of 120-139 and diastolic measures of 80-89 are considered at risk (or pre-hypertension). Systolic measures of ≥140 and diastolic measures of ≥90 are considered high.|Week 52|Intent-to-treat with available data at Week 52|||mmHg||Standard Deviation|Mean
2676797|NCT01436305|Secondary|HbA1c Measured at Days 28 & 84, and Weeks 24, 36, 52, 72, 104 and 156|Hemoglobin A1c (HbA1c) measures the average blood glucose levels over 8-12 weeks, thus acting as a useful long-term gauge of blood glucose control. A value below 6.0% reflects normal levels, 6.0% to 6.4% reflects prediabetes, and a value of ≥ 6.5% reflects diabetes.|Day 28, Day 84, Week 24, Week 36, Week 52, Week 72, Week 104, Week 156|Intent-to-treat with available data|||percent||Standard Deviation|Mean
2676798|NCT01436305|Secondary|Count of Participants With Treated Diabetes Between Day 14 and Wk 52|Treated diabetes is defined as the receipt of oral medication or insulin for >14 days between 14 days and 52 weeks post-transplant|Day 14 to Week 52|Intent-to-treat with available data|||Participants|||Count of Participants
2676799|NCT01436305|Secondary|Count of Participants With Either New Onset Diabetes After Transplant (NODAT) or Impaired Fasting Glucose (IFG) at Wk 52 Based on Criteria Specified by the ADA and WHO|"New onset diabetes is the development of diabetes post-kidney transplant. It was identified by the clinical sites caring for each participant and reported directly in the clinical database. Impaired fasting glucose (IFG) is a determination made by referencing glucose measurements obtained from a standard chemistry panel. Any fasting glucose measure that is between 110 and 125 mg/dL is classified as IFG.~Acronyms: American Diabetes Association (ADA); World Health Organization (WHO)."|Week 52|Intent-to-treat|||Participants|||Count of Participants
2676800|NCT01436305|Secondary|Count of Participants With de Novo Anti-donor HLA Antibodies at Wk 52|The presence of antibodies reactive to Histocompatibility Antigen (HLA) molecules expressed on the renal allograft have been associated with both acute and chronic injury to the transplanted kidney. The development of de novo anti- donor HLA antibodies may mean a person is more likely to reject the graft.|Week 52|Intent-to-treat|||Participants|||Count of Participants
2676801|NCT01436305|Secondary|Type of Treatment of Rejection|"Upon having a biopsy performed, persons often receive treatment for rejection based on the results of the biopsy, which may or may not have shown signs of rejection. Details of biopsy findings and corresponding treatment are presented here for each instance of treatment for rejection. Acronyms and abbreviations are defined below.~ACR=Acute Cellular Rejection ATG=Anti-thymocyte globulin therapy Chr. AMR=Chronic Antibody Mediated Rejection Gd.=Grade IFTA=Interstitial Fibrosis and Tubular Atrophy IVIG=Intravenous Immunoglobulin therapy.~Only 'for cause' biopsies were performed post-transplant; thus, it is possible for a participant to be included in the analysis population and not have a biopsy for this outcome measure."|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Biopsy|Biopsies||Number
2676802|NCT01436305|Secondary|Count of Participants With Antibody Mediated Rejection|Antibody mediated rejection (AMR) is defined as diffusely positive staining for C4d, presence of circulating anti-donor antibodies and morphologic evidence of acute tissue injury.|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Participants|||Count of Participants
2676803|NCT01436305|Secondary|Count of Participants by Severity of First Acute Cellular Rejection by Wk 52|"Acute cellular rejection is when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade ≥ IA by Banff 2007 criteria. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection. Originally, this endpoint was worded as The severity of first and highest acute cellular rejection within the first 52 weeks. But since the highest grade for each subject coincided with the first ACR episode for each subject, only a summary of severity of the first episode is presented here."|Transplantation through Week 52|Intent-to-treat|||Participants|||Count of Participants
2676804|NCT01436305|Secondary|Count of Participants With Acute Cellular Rejection Grade Equal to or Greater Than IA, by the Banff 2007 Criteria|Acute cellular rejection is when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade ≥ IA by Banff 2007 criteria.|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Participants|||Count of Participants
2676805|NCT01436305|Secondary|Count of Participants With CAN/IFTA Grade I, II or III at Any Time Post-transplant|CAN/IFTA grades were determined per local pathology interpretations of biopsy tissue. These grades reflect the severity of interstitial fibrosis and tubular atrophy present in the tissue obtained during a kidney biopsy. Higher grades indicate greater severity in interstitial fibrosis and tubular atrophy present the kidney biopsy tissue.|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Participants|||Count of Participants
2676806|NCT01436305|Secondary|An Increase of One or More Grades of CAN/IFTA When Comparing the Implantation and Subsequent Protocol Biopsies|CAN/IFTA grades reflect the severity of interstitial fibrosis and tubular atrophy present in the tissue obtained during a kidney biopsy. Higher grades indicate greater severity in interstitial fibrosis and tubular atrophy present the kidney biopsy tissue. The aim of this measure was to compare central lab reviewed pre-implantation biopsies to post-transplant biopsies, as pre-specified per protocol; however, the central lab had an inadequate set of biopsies to proceed with evaluation.|Week 52, Week 104, and Week 156|There was an insufficient number of biopsies collected for the summarized data to be reliable.||||||
2676807|NCT01436305|Secondary|Count of Participants With Delayed Graft Function Post-Transplant|Delayed graft function is defined as dialysis in the first week on one or more occasions for any indication other than the treatment of acute hyperkalemia in the setting of otherwise acceptable renal function|Any time within the first week post-transplant|Intent-to-treat|||Participants|||Count of Participants
2676808|NCT01436305|Secondary|The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine|The estimated Glomerular Filtration Rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI). A score of ≥90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure. An estimate of the slope, or change over time, in eGFR was produced using standard statistical linear modeling procedures. The estimate was then re-scaled so that it can be interpreted as a change in eGFR per month. Positive numbers indicate increasing kidney function. Larger numbers indicate greater change in kidney function.|Week 52, Week 104, and Week 156|Intent-to-treat with available data|||Change in eGFR (mL/min/1.73m^2) by month||Standard Deviation|Mean
2676809|NCT01436305|Secondary|Mean Calculated eGFR Using MDRD 4 Variable Model|The estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease equation (MDRD). A score of ≥90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure.|Week 52, Week 104, and Week 156|Intent-to-treat population with available data at Weeks 52, 104 and 156|||mL/min/1.73m^2||Standard Deviation|Mean
2676810|NCT01436305|Secondary|Count of Participants With CKD Stage 4 or 5|"The stages of Chronic Kidney Disease are defined using the participant's GFR value as indicated below.~Stage 1 if GFR value is ≥90; Stage 2 if 60 ≤ GFR < 90; Stage 3A if 45 ≤ GFR < 60; Stage 3B if 30 ≤ GFR < 45; Stage 4 if 15 ≤ GFR < 30; Stage 5 if GFR < 15.~Stage 1 means kidney function is normal. Stage 2 indicates mildly reduced kidney function, pointing to kidney disease. Stages 3A abd 3B indicate moderately reduced kidney function. Stage 4 indicates severely reduced kidney function. Stage 5 indicates very severe or end stage kidney failure."|Week 52, Week 104, and Week 156|Intent-to-treat population with available data at Weeks 52, 104 and 156|||Participants|||Count of Participants
2676811|NCT01436305|Secondary|Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant|"The stages of Chronic Kidney Disease are defined using the participant's GFR value as indicated below:~Stage 1 if GFR value is ≥90; Stage 2 if GFR value is ≥60 and < 90; Stage 3A if 45 ≤GFR < 60; Stage 3B if 30 ≤ GFR < 45; Stage 4 if 15 ≤GFR < 30;l Stage 5 if GFR < 15.~Stage 1 means kidney function is normal. Stage 2 indicates mildly reduced kidney function, pointing to kidney disease. Stages 3A and 3B indicate moderately reduced kidney function. Stage 4 indicates severely reduced kidney function. Stage 5 indicates very severe or end stage kidney failure."|Week 52, Week 104, and Week 156|Intent-to-treat population with available data at Weeks 52, 104 and 156|||Participants|||Count of Participants
2676812|NCT01436305|Secondary|Count of Participants With Estimated Glomerular Filtration Rate (GFR) < 60 mL/Min/1.73 m^2 by CKD EPI|GFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI). A score of ≥90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure. This measure specifically looked at participants with scores less than 60.|Week 52, Week 104, and Week 156|Intent-to-treat population with available data at Weeks 52, 104 and 156.|||Participants|||Count of Participants
2676813|NCT01436305|Secondary|Count of Participants With Biopsy Proven Acute Rejection at Any Time Post-Transplant|Biopsy proven acute rejection was defined as histologic evidence of borderline or higher cellular rejection per local pathologist.|Transplantation through last study visit (up to week 156)|Intent-to-treat|||Participants|||Count of Participants
2676814|NCT01436305|Primary|Mean Glomerular Filtration Rate (GFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52|GFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI). A score of ≥ 90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure.|Week 52|Intent-to-treat population with measurable data at Week 52|||mL/min/1.73m^2||Standard Deviation|Mean
2676815|NCT01436279|Secondary|Difficulty of Procedure|"Outcome measure is the number and percentage of participants where the provider rated the procedure as difficult or very difficult. Provider assessment of difficulty of procedure categories were: very easy, easy, moderate, difficult, or very difficult."|After completion of procedure||||Participants|||Count of Participants
2676816|NCT01436279|Secondary|Acceptability to Patient|"Patient was asked whether they would choose to be in the same group again if they had a similar procedure again. The number of participants whose response was yes is being reported."|After procedure completion||||Participants|||Count of Participants
2676817|NCT01436279|Secondary|Cervical Dilation Achieved|Cervical dilation at start of procedure|At time of abortion||||mm||Standard Deviation|Mean
2676818|NCT01436279|Secondary|Pain Medication (Midazolam) During the Abortion|Amount of pain medication used during the procedure: reported as milligrams of midazolam|Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days.||||mg||Standard Deviation|Mean
2676824|NCT01436253|Primary|Percentage of Participants With Reduced Cardiovascular Risk|Cardiovascular risk assessment to determine the 10-year risk for developing cardiovascular disease was done using Framingham risk scoring; categories scored are age, high density lipoprotein (HDL) cholesterol value, total cholesterol value, history of cigarette smoking, and systolic blood pressure. The total of all the points for each risk factor is used to assign a percentage of risk for the occurence of cardiovascular disease within 10 years. Total points for men range from -9 to +37 and for women from -8 to +46; >=17 total points for men, and >=25 total points for women indicates a >=30% risk of developing cardiovascular disease.|Baseline and Month 3|Participants meeting all inclusion and exclusion criteria.|||Percentage of participants|||Number
2676825|NCT01436253|Primary|Percentage of Participants Achieving Target Lipid Values|Target total cholesterol value was <4.5 mmol/L and target low densisty lipoprotein (LDL) value was <2.5 mmol/L|Baseline and Month 3|Participants meeting all inclusion and exclusion criteria.|||Percentage of participants||95% Confidence Interval|Number
2676826|NCT01436201|Primary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin||Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17|Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin Tmax data.|||hours||Full Range|Median
2676827|NCT01436201|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Digoxin||Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17|Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin Cmax data.|||nanograms per milliliter||Geometric Coefficient of Variation|Geometric Mean
2676828|NCT01436201|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Digoxin||Predose (Digoxin) and up to 24 hours postdose on Days 7, 10, and 17|Participants who received at least one dose of study drug (digoxin or dulaglutide) with evaluable digoxin AUC data.|||nanograms times hours/milliliter||Geometric Coefficient of Variation|Geometric Mean
2676829|NCT01436175|Secondary|PRUQ-MDD - Effect of Depressive Symptoms|The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions on a 0 to 10 point scale - 1. During past week, how much did depressive symptoms affect work productivity; 2. During past week, how much did depressive symptoms affect regular non-work daily activities. Higher scores indicates more effect of depressive symptoms on work productivity and non-work daily activities.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories|||units on scale||Standard Deviation|Mean
2676830|NCT01436175|Secondary|PRUQ-MDD - Number of Hours|The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions - 1. How many hours do you usually work or would you usually be expected to work (hrs/week); 2. How many hours did you actually work last week; 3. On average, how many hours do you volunteer per week. Number of hours are reported.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||hours||Standard Deviation|Mean
2676831|NCT01436175|Secondary|PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)|The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions - 1. How many times did you visit the following healthcare providers in the past month: Family doctor/primary care, Non-physician healthcare practitioner (NPHP), Psychiatrist/Psychologist/Counselor (PPC); 2. How many times did you take one of the tests, mentioned below, during the past month: Blood test, CT Scan, X Ray, Renal function, Thyroid function; and 3. How many times did you visit the hospital emergency room (ER), urgent care facility (UCF) or an after-hours clinic (AHC) in the past month. Number of events (visit to health care provider, visit to hospital facilities, and number of times a test was performed) are reported.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories|||events||Standard Deviation|Mean
2676832|NCT01436175|Secondary|PRUQ-MDD - Number of Days of Resource Utilization|The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Number of nights in medical/surgical ward, number of nights in ICU, and number of days a participant received home care in the past month are reported.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories.|||days||Standard Deviation|Mean
2676833|NCT01436175|Secondary|Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)|"The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered the following questions:~1. Were you hospitalized in the past month, 2. Do you work for pay, 3. If you missed time at work last week, please note all the reasons why, 4. Would you say that the past week was typical, like the rest of the 3 weeks this month, in terms of your working hours, 5. Do you do volunteer work (VW), and 6. If you do not receive money for your work and do not participate in volunteer work, the reason is.~Number of participants with response is reported."|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure|||participants|||Number
2676834|NCT01436175|Secondary|Amphetamine Cessation Symptom Assessment (ACSA) Total Score|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|Week 53|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2676835|NCT01436175|Secondary|Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET|CSFQ-14 is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning. Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).|Baseline, Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories.|||units on a scale||Standard Deviation|Mean
2676836|NCT01436175|Secondary|Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is a 16-item self-report questionnaire which evaluates general participant satisfaction with health, mood, relationships, functioning in daily life, and their treatment. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total raw score (summary scale score) was calculated by summing item scores 1 to 14 (total raw score range: 14 to 70). Item 15 (satisfaction with medication, raw score range: 1 to 5) and Item 16 (overall satisfaction and contentment; raw score range: 1 to 5) were stand-alone items. For reporting, summary scale, Item 15 and Item 16 raw scores were transformed into percentage maximum possible score which ranged from 0 to 100, where higher scores are indicative of greater enjoyment or satisfaction.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure, n = participants evaluable for specified categories|||units on a scale||Standard Deviation|Mean
2676837|NCT01436175|Secondary|Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)|QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression. The QIDS-SR was only assessed in the SPD489-322 antecedent study. The QIDS-SR total score is calculated as the sum of the highest score on any 1 of Items 1-4, Item 5, the highest score on any 1 of Items 6-9, Items 10-14, the highest score on either Item 15 or 16.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure|||units on a scale||Standard Deviation|Mean
2676838|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Visual Analog Scale|EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. EQ-5D-5L Visual Analog Scale score is numbered from 0 to 100, where a score of 100 is the best health a participant can imagine|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2676839|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||participants|||Number
2676840|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||participants|||Number
2676841|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||participants|||Number
2676842|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||participants|||Number
2676843|NCT01436175|Secondary|EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility|Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||participants|||Number
2676844|NCT01436175|Secondary|Short Form-12 Health Survey Version 2 (SF-12V2)|SF-12V2 is a multi-purpose, 7-item survey that measures 8 domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It is expressed by two summary measures (Aggregate Physical and Aggregate Mental) for which values can range from 0 to 100. A higher score is indicative of a better health state.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||units on a scale||Standard Deviation|Mean
2676845|NCT01436175|Secondary|Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I)|Participants who did not have Clinical Global Impressions - Severity of Illness (CGI-S) assessed at Week 8 in the antecedent study should not have had CGI-I assessed in this study and were excluded from the summary of CGI-I. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.|Week 52/ET|FAS. Here, Number of Participants Analyzed = participants who were evaluable for this outcome measure.|||participants|||Number
2676857|NCT01436162|Secondary|Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2)|Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||95% Confidence Interval|Least Squares Mean
2676846|NCT01436175|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET|"Designed to evaluate the extent to which illness symptoms impact a participant's life in 3 areas: work, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.~Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162])."|Baseline, Week 52/ET|Full Analysis Set (FAS) included all participants in the Safety Analysis Set who had at least 1 clinical experience outcome assessment in the study. Here n = participants evaluable at specified time-points.|||units on a scale||Standard Deviation|Mean
2676847|NCT01436175|Primary|Change From Baseline in Pulse Rate at Week 52|Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).|Baseline, Week 52/ET|Safety Analysis Set. Here n = participants evaluable at specified time-points.|||beats per minute(bpm)||Standard Deviation|Mean
2676848|NCT01436175|Primary|Change From Baseline in Diastolic Blood Pressure at Week 52|Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).|Baseline, Week 52/ET|Safety Analysis Set. Here n = participants evaluable at specified time-points.|||mmHg||Standard Deviation|Mean
2676849|NCT01436175|Primary|Change From Baseline in Systolic Blood Pressure at Week 52|Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 [NCT01435759], SPD489-322 [NCT01436149], and SPD489-323 [NCT01436162]).|Baseline, Week 52/ET|Safety Analysis Set. Here n = participants evaluable at specified time-points.|||millimeter of mercury(mmHg)||Standard Deviation|Mean
2676850|NCT01436175|Primary|Columbia-Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviour during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Week 5 up to Week 52/Early Termination(ET)|Safety analysis set included all participants who took at least 1 dose of investigational product and had at least 1 post-Visit 0 (Week 0) safety assessment in this study|||participants|||Number
2676851|NCT01436162|Secondary|Amphetamine Cessation Symptom Assessment (ACSA) - Total Aggregate Score|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|8 weeks|Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 safety assessment (e.g., coming back for any visit, reporting of an AE, or reporting the absence of AEs) after the Augmentation Baseline Visit (Visit 8).|||Score||Standard Deviation|Mean
2676852|NCT01436162|Secondary|Columbia Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.|Up to 8 weeks|Safety Analysis Set: All subjects who took at least 1 dose of randomized investigational product and who had at least 1 safety assessment (e.g., coming back for any visit, reporting of an adverse event [AE], or reporting the absence of AEs) after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
2676853|NCT01436162|Secondary|Mean Change From Baseline in the Multidimensional Assessment of Fatigue (MAF) Global Fatigue Index (GFI)|MAF contains 16 items scored on a scale from 1 (not at all) to 10 (a great deal). Answers are converted to a Global Fatigue Index with total scores ranging from 1 (no fatigue) to 50 (severe fatigue). Lower scores indicate less fatigue.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||Standard Error|Least Squares Mean
2676854|NCT01436162|Secondary|Clinical Global Impressions - Global Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
2676855|NCT01436162|Secondary|Mean Change in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Female|The CSFQ-14 is a short-form interview/questionnaire that measures illness- and medication-related changes in sexual functioning. A 5-point Likert scale is used ranging from 1 (never) to 5 (always). The CSFQ-14 total score can range from 14 to 70, with lower scores being associated with worsened sexual functioning.|Up to 8 weeks|Full Analysis Set: Female subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||Standard Deviation|Mean
2676856|NCT01436162|Secondary|Mean Change in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score Male|The CSFQ-14 is a short-form interview/questionnaire that measures illness- and medication-related changes in sexual functioning. A 5-point Likert scale is used ranging from 1 (never) to 5 (always). The CSFQ-14 total score can range from 14 to 70, with lower scores being associated with worsened sexual functioning.|Up to 8 weeks|Full Analysis Set: Male subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||Standard Deviation|Mean
2676899|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Head CT Examinations.||One year||||mGy||Standard Deviation|Mean
2676983|NCT01435577|Secondary|Number of Participants With 50% Response After 48 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 48 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.|Baseline value to 48 hours after first study drug administration|Full analysis set.|||participants|||Number
2676858|NCT01436162|Secondary|Mean Change From Baseline in Abbreviated Brief Assessment of Cognition Affective Disorders (ABAC-A) Composite T-Scores|The ABAC-A is a rater-administered series of activities designed to be sensitive to the critical cognitive deficits in affective disorders and schizophrenia. There are 6 subtests of the ABAC-A: List Learning (verbal memory); Digit Sequencing Task (working memory); Token Motor Task (motor speed); Verbal Fluency; Symbol Coding (attention and processing speed); and Tower of London Test (executive functions). The ABAC-A Composite T-score change from Augmentation Baseline Visit (Visit 8; Week 8) at Visit 14/Early Termination (ET) (Week 16/ET) was analyzed.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||t-score||95% Confidence Interval|Least Squares Mean
2676859|NCT01436162|Secondary|Mean Change From Baseline Over Time in MADRS Total Score|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of MADRS total score after the Augmentation Baseline Visit (Visit 8). Sample size (n) of MADRS total score at each visit differed from sample size (N) of the FAS.|||units on a scale||95% Confidence Interval|Least Squares Mean
2676860|NCT01436162|Secondary|Percent of Participants Achieving Remission on the MADRS|MADRS remission was defined as a MADRS total score of ≤10.|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
2676861|NCT01436162|Secondary|Percentage of Participants Achieving a 50% Response on the MADRS|The percentage of subjects who achieved a 50% response (i.e. ≥50% reduction in MADRS total score from the Lead-in Baseline, Visit 2).|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
2676862|NCT01436162|Secondary|Percentage of Participants Achieving a 25% Response on the MADRS|The percentage of subjects who achieved a 25% response (i.e. ≥25% reduction in MADRS total score from the Lead-in Baseline, Visit 2).|Up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
2676863|NCT01436162|Secondary|Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score at 8 Weeks|Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.|8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||95% Confidence Interval|Least Squares Mean
2676864|NCT01436162|Primary|Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at 8 Weeks|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||95% Confidence Interval|Least Squares Mean
2676865|NCT01436149|Secondary|Amphetamine Cessation Symptom Assessment (ACSA)|ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||Standard Deviation|Mean
2676866|NCT01436149|Secondary|Columbia Suicide Severity Rating Scale (C-SSRS)|C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. The assessment is done by the nature of the responses, not by a numbered scale.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
2676867|NCT01436149|Secondary|Clinical Global Impressions - Global Improvement (CGI-I)|Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
2676868|NCT01436149|Secondary|Mean Change From Baseline in the Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)|The short form is a 16-item self-report questionnaire which evaluates general subject satisfaction with health, mood, relationships, functioning in daily life, and the treatment being taken. Overall level of satisfaction is evaluated on a 5-point scale from 1 (very poor) to 5 (very good). The total score ranges from 14-70 (last two items on the form are not included in the total score). A higher score indicates a better quality of life.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||95% Confidence Interval|Least Squares Mean
2677029|NCT01435356|Secondary|Overall Survival|To evaluate overall survival in the overall study population. Overall Survival was defined as the interval from randomization to the date of death, irrespective of the cause of death; patients still alive were censored at the date of the last assessment.|5 years||||months||95% Confidence Interval|Mean
2676869|NCT01436149|Secondary|Mean Change From Baseline in the Short Form-12 Health Survey V2 (SF-12V2)|Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||95% Confidence Interval|Least Squares Mean
2676870|NCT01436149|Secondary|Mean Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR)|The QIDS-SR is a self-administered questionnaire designed to rate depressive symptoms. The scale contains 16 items, each scored using a 4-point scale ranging from 0 (representing the most favorable response [low amount of symptom]) to 3 (representing the least favorable response [frequent/intense symptom]). The total score could range from 0 (no depression) to 27 (very severe depression). Higher scores represent more severe depressive symptoms.|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||95% Confidence Interval|Least Squares Mean
2676871|NCT01436149|Secondary|Mean Change From Baseline Over Time in MADRS Total Score|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|Baseline and up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||95% Confidence Interval|Least Squares Mean
2676872|NCT01436149|Secondary|Percentage of Participants Achieving Remission on the MADRS|MADRS remission was defined as a MADRS total score of ≤10. A comparison was performed at Visit 14/ET (Week 16/ET).|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
2676873|NCT01436149|Secondary|Percentage of Participants Achieving a 50% Response on the MADRS|The percentage of subjects who achieved a 50% response (i.e., ≥50% reduction in MADRS total score from Lead-in Baseline, Visit 2; Week 0). A comparison was performed at Visit 14/ET (Week 16/ET).|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
2676874|NCT01436149|Secondary|Percentage of Participants Achieving a 25% Response on the MADRS|The percentage of subjects who achieved a 25% response (i.e., ≥25% reduction in MADRS total score from Lead-in Baseline, Visit 2; Week 0). A comparison was performed at Visit 14/Early Termination (ET) (Week 16/ET).|up to 8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||percentage of participants|||Number
2676875|NCT01436149|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score at up to 8 Weeks|Designed to evaluate the extent to which illness symptoms impact a subject's life in 3 areas: work/school, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment.|8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||95% Confidence Interval|Least Squares Mean
2676876|NCT01436149|Primary|Mean Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.|8 weeks|Full Analysis Set: Subjects who took at least 1 dose of randomized investigational product and who had at least 1 valid primary efficacy measurement of the MADRS total score after the Augmentation Baseline Visit (Visit 8).|||units on a scale||95% Confidence Interval|Least Squares Mean
2676877|NCT01436110|Secondary|Number of Participants Who Withdrew Due to Lack of Efficacy During the 24-week Treatment Period|The reason for withdrawal was lack of efficacy if a participant was withdrawn due to: clinic FEV1 falling below the FEV1 stability limit; participant experiencing at least 4 days of AM or PM PEF falling below the PEF stability limit and/or at least 3 days of >=12 inhalations/day of albuterol/salbutamol usage during the 7 days immediately preceding any contact; or the occurrence of an asthma exacerbation, defined as the deterioration of asthma requiring the use of systemic (oral, parenteral, or depot) corticosteroids for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. The FEV1 stability limit was calculated as the best pre-salbutamol/albuterol FEV1 at Visit 2 * 80%. The PEF stability limit was calculated as the mean AM PEF from the available 7 consecutive days preceding Visit 2 * 80%.|From the first dose of the study medication until Week 24/Early Withdrawal|ITT Population|||Participants|||Number
2676878|NCT01436110|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 24-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
2676879|NCT01436110|Secondary|Change From Baseline in Daily Morning (AM) PEF Averaged Over the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||L/min||Standard Error|Least Squares Mean
2676880|NCT01436110|Secondary|Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters/minute (L/min)||Standard Error|Least Squares Mean
2676881|NCT01436110|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
2676882|NCT01436110|Primary|Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 24 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline, on-treatment measurement at scheduled clinic visits was used to impute the missing measurements.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants with non-missing covariates and post-Baseline FEV1 data were analyzed.|||Liters||Standard Error|Least Squares Mean
2676883|NCT01436084|Primary|Number of Participants With Overall Response|Overall response based on hematologic improvement defined by International Working Group (IWG) response criteria in myelodysplasia. Complete remission (CR): Bone marrow of 5% myeloblasts with normal maturation of all cell lines, noted persistent dysplasia; Partial Remission: CR criteria if abnormal before treatment except Bone marrow blasts decreased by 50% over pretreatment but still > 5%; Marrow CR: Bone marrow 5% myeloblasts and decrease by 50% over pretreatment. Bone marrow aspirate pre-therapy (Day 0) and on Day 28 of first cycle then every 3 cycles. Responses must last at least 4 weeks.|28 days to one year|Study was halted prior to completion of treatment and assessment for any participant(s).||||||
2676884|NCT01436071|Secondary|Number of Participants Who Withdrew Due to a Lack of Efficacy During the 12-week Treatment Period|The reason for withdrawal was lack of efficacy if a participant was withdrawn due to: clinic FEV1 falling below the FEV1 stability limit; participant experiencing at least 4 days of AM or PM PEF falling below the PEF stability limit and/or at least 3 days of >=12 inhalations/day of albuterol/salbutamol usage during the 7 days immediately preceding any contact; or the occurrence of an asthma exacerbation, defined as the deterioration of asthma requiring the use of systemic (oral, parenteral, or depot) corticosteroids for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. The FEV1 stability limit was calculated as the best pre-salbutamol/albuterol FEV1 at Visit 2 * 80%. The PEF stability limit was calculated as the mean AM PEF from the available 7 consecutive days preceding Visit 2 * 80%.|From the first dose of the study medication until Week 12/Early Withdrawal|ITT Population|||Participants|||Number
2676885|NCT01436071|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Over the 12-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
2676886|NCT01436071|Secondary|Change From Baseline in Daily Morning (AM) PEF Averaged Over the 12-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||L/min||Standard Error|Least Squares Mean
2676887|NCT01436071|Secondary|Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 12-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 12-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters/minute (L/min)||Standard Error|Least Squares Mean
2676888|NCT01436071|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 12-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 12|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
2676889|NCT01436071|Primary|Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 12 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 12 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 12 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing value.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received >=1 dose of study medication, except for the par. of one investigator (excluded after good clinical practice [GCP] issues identified during a site audit). Only those par. with non-missing covariates and a post-Baseline FEV1 measurement were analyzed.|||Liters||Standard Error|Least Squares Mean
2676890|NCT01436045|Primary|Trails B - Errors|The results are presented as the mean sum of the errors during the Trails B assessment For each of these, a higher number of errors is indicative of a higher cognitive deficit.|20 minutes post-intranasal administration||||mean number of errors||Standard Error|Mean
2676891|NCT01436045|Primary|Trails B - Seconds|The results are presented as the number of seconds to complete Trails B. For each of these, a higher number of seconds is indicative of a higher cognitive deficit.|20 minutes post-intranasal administration||||mean seconds||Standard Error|Mean
2676892|NCT01436045|Secondary|Olfactory Function|"The Sniff Magnitude Test (SMT) measures olfactory function not influenced by cognitive problems (minimal dependence on language, cognitive ability, memory, and odor naming ability). Sniff magnitude ratios are calculated as a ratio of sniff magnitudes (area under the sniff curve). Lower sniff magnitude ratios indicate more impairment.~[average sniff magnitude of malodor/average sniff magnitude to a null odor]"|60 minute post intranasal administration||||ratio of area under the sniff curve||Standard Error|Mean
2676893|NCT01436045|Primary|Cognitive Performance|"The results are presented as a mean number of correct responses for each cognitive assessment.~For each of these, a lower number correct is indicative of a higher cognitive deficit.~Ranges are as follows: RBANS List Learning (0-40), RBANS Story Memory (0-24), RBANS Figure Copy (0-20), RBANSLine Orientation (0-20), RBANS Semantic Fluency (0-unlimited), RBANS List Recall (0-10), RBANS List Recognition (0-20), RBANS Story Recall (0-12), RBANS Figure Recall (0-20), Digit Span Forward (0-16), Digit Span Backward (0-16), Boston Naming (0-15)."|20 minutes post-intranasal administration||||mean total correct responses||Standard Error|Mean
2676894|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Spine CT Examinations.||one year||||mGy||Standard Deviation|Mean
2676895|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Chest Abdomen and Pelvis CT Examinations.||one year||||mGy||Standard Deviation|Mean
2676896|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Cardiac CT Examinations.||one year||||mGy||Standard Deviation|Mean
2676897|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Abdomen CT Examinations.||one year||||mGy||Standard Deviation|Mean
2676898|NCT01436006|Primary|Value of Mean Volumetric Computed Tomography Dose Index (CTDI Vol) for Chest CT Examinations.||one year||||mGy||Standard Deviation|Mean
2676900|NCT01435928|Secondary|Intent to Attend (ITA) Assessment at Open-label Baseline|"The ITA assessment will be administered by a research staff member. The response is recorded on a 10-point scale, with 0 = Not at all and 9 = Extremely. The ITA allowed the site to capture data regarding dropout risk. The following question was completed at the screening visit: How likely is it that you will complete the study?"|Open Label Baseline|All subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.|||units on a scale||Standard Deviation|Mean
2676901|NCT01435928|Secondary|Smoking Questionnaire (Average Number of Cigarettes Per Day) at Week 28 (LOCF)|Smoking history and frequency were assessed during the study by a research staff member. During the study, smoked subjects were asked about the average number of cigarettes per day they smoked over the last week.|28 Weeks - Double Blind Phase|ITT Subjects who smoked|||number of cigarettes smoked daily||Standard Deviation|Mean
2676902|NCT01435928|Other Pre-specified|EuroQol (EQ-5D): EQ-VAS Score|"The EQ-5D is a self-administered, standardized measure of health states consisting of two parts: EQ-5D descriptive system consisting of one question in each of five dimensions (mobility, self-care, pain, usual activities, and anxiety) with three possible response levels per question, classifying patients into one of 243 distinct health states, and a 20-cm visual analogue health status rating.~The 20-cm visual analog scale (VAS) has endpoints labeled best imaginable health state and worst imaginable health state that are anchored at 100 and 0, respectively. Respondents are asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS, which best represents their own health on that day."|Double-blind phase - 28 Weeks|There were 5 Lurasidone subjects and 3 placebo subjects that had no post-baseline assessment.|||units on a scale||Standard Deviation|Mean
2676903|NCT01435928|Secondary|Brief Adherence Rating Scale|The Brief Adherence Rating Scale (BARS) is a clinician-administered adherence assessment instrument that consists of four items including three questions and a visual analog rating scale (VAS) to assess the percentage (0 - 100%) of doses taken by the subject in the previous month.|Double-blind phase - 28 Weeks|There were 6 Lurasidone subjects and 2 placebo subjects that had no post-baseline assessment.|||percentage of monthly doses taken||Standard Deviation|Mean
2676904|NCT01435928|Secondary|Change From Double-blind Baseline in Modified Specific Levels of Functioning (SLOF) Total Score|The modified SLOF scale is designed to measure directly observable behavioral functioning and daily living skills of patients with chronic mental illness. The modified SLOF consists of 24 items divided into two subscales: Social functioning (comprised of 7 items from interpersonal relationships section) and Community Living Skills (comprised of 17 items from activities and work skills sections). Each item is rated on a 5-point scale and mapped to 0 to 4 with a higher score indicating worse condition. The total score will be the sum of all 24 items and ranges from 0 to 96.|Double-blind phase - 28 Weeks|There were 19 Lurasidone subjects and 20 placebo subjects that had no post-baseline assessment.|||units on a scale||Standard Error|Least Squares Mean
2676905|NCT01435928|Secondary|Change From Double-blind Baseline in Short Form-12v2 Health Survey (SF-12v2) Physical Component Score|"The SF-12v2 is a self-administered, multipurpose short-form (SF) generic measure of health status. It was developed to be a shorter, yet valid, alternative to the SF-36 for use in large surveys of general and specific populations as well as in large longitudinal studies of health outcomes. The 12 items in the SF-12v2 are a subset of those in the SF-36; SF-12v2 includes one or two items from each of the eight health concepts with higher scores indicative of higher functioning and better health. The Physical Component Score is a composite of the Physical Functioning, Role Functioning, Bodily Pain and General Health scales.~Physical Composite Scores (PCS) is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health."|Double-blind phase - 28 Weeks|There were 5 Lurasidone subjects and 3 placebo subjects that had no post-baseline SF-12 assessment.|||units on a scale||Standard Error|Least Squares Mean
2676906|NCT01435928|Secondary|Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score|"The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity."|Double-blind phase - 28 Weeks|There were four Lurasidone subjects and 2 placebo subjects that had no post-baseline MADRS assessment.|||units on a scale||Standard Error|Least Squares Mean
2676907|NCT01435928|Secondary|Change From Double-blind Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score|The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.|Double-blind phase - 28 Weeks||||units on a scale||Standard Error|Least Squares Mean
2676908|NCT01435928|Secondary|Change From Double-blind Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score|The PANSS is an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure is comprised of 30 items and three scales: the Positive scale contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility; the Negative scale contains seven questions to assess blunted effect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addresses other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS total score is the sum of all 30 items and ranges from 30 through 210. A higher score is associated with greater illness severity.|Double-Blind phase - 28 Weeks||||units on a scale||Standard Error|Least Squares Mean
2676909|NCT01435928|Secondary|Time to All-cause Discontinuation|The Kaplan-Meier method was used for estimation.|Double-blind phase - 28 weeks||||days||95% Confidence Interval|Median
2676910|NCT01435928|Primary|Time to First Relapse Event During Double-blind Phase|The Kaplan-Meier method is used for the estimation.|Double-blind phase - 28 Weeks||||days||95% Confidence Interval|Median
2676911|NCT01435824|Secondary|Volume of Distribution/F|It was estimated from (Clearance/F)/Kel. Elimination rate constant (Kel) was estimated from the terminal log-linear phase of the concentration-time profiles. Then, elimination half-life was calculated as follows: ln2/Kel.|Data points were taken at 0, 0.25, 0.5, 1, 1.5, 3, 4 and 8 hours after dosing.||||l/kg||Standard Deviation|Mean
2676912|NCT01435824|Secondary|Clearance/F|The log-trapezoidal method was used to calculate AUC last (AUC from time 0 to 8 h), and AUC∞ was estimated using an elimination rate constant (Kel) of the terminal log-linear phase (β phase) of the concentration time profile extrapolating to time infinity. Then, CL/F was derived from Dose/AUC∞. F is bioavailability, which cannot be determined in this study, and therefore, we estimate CL/F, but not CL itself.|Data points were taken at 0, 0.25, 0.5, 1, 1.5, 3, 4 and 8 hours after dosing.||||ml/kg/min||Standard Deviation|Mean
2676913|NCT01435824|Secondary|Elimination Half-life|Elimination rate constant (Kel) was estimated from the terminal log-linear phase of the concentration-time profiles. Then, elimination half-life was calculated as follows: ln2/Kel.|Data points were taken at 0, 0.25, 0.5, 1, 1.5, 3, 4 and 8 hours after dosing.||||min||Standard Deviation|Mean
2676914|NCT01435824|Primary|Tmax|Time to reach Cmax after administration|Data points were taken at 0, 0.25, 0.5, 1, 1.5, 3, 4 and 8 hours after dosing.||||min||Standard Deviation|Mean
2676915|NCT01435824|Primary|Cmax|A maximum plasma concentration of amoxicillin within the time frame of a dosing|0, 0.25, 0.5, 1, 1.5, 3, 4 and 8 hours after dosing||||ng/ml||Standard Deviation|Mean
2676916|NCT01435824|Primary|Area Under the Curve to 8h (AUC Last)|Amoxicillin plasma concentrations were determined by HPLC-MS/MS and PK parameters were estimated using a model-independent approach. Specifically, the log-trapezoidal method was used to calculate AUC last (AUC from time 0 to 8 h).|Baseline, 0.25, 0.5, 1, 1.5, 3, 4 and 8 hours after dosing||||mcg*min/mL||Standard Deviation|Mean
2676917|NCT01435824|Primary|Area Under the Curve to Time Infinity (AUC to Time Infinity)|"Amoxicillin plasma concentrations were determined by HPLC-MS/MS and AUC∞ (to time infinity) was estimated using a model-independent approach. Specifically, the log-trapezoidal method was used to calculate AUC last (AUC from time 0 to 8 h), and AUC∞ was further estimated with the elimination rate constant (Kel) of the terminal log-linear phase (β phase) of the concentration time profile extrapolating to time infinity as follows:~AUC∞ = AUC last + [C]8h/Kel; where [C]8h is the plasma concentration at time 8 h postdose."|Baseline, 0.25, 0.5, 1, 1.5, 3, 4 and 8 hours after dosing||||mcg*min/mL||Standard Deviation|Mean
2676918|NCT01435798|Secondary|Satisfaction|Satisfaction with study treatment assessed over the 7 days prior to admission (5-point categorical scale)|Last week prior to admission (end of 1-week maintenance period)||||Participants|||Count of Participants
2676919|NCT01435798|Primary|Mean Pain Intensity (Percent Change From Baseline)|Primary outcome was percent change from baseline in mean pain intensity (transformed Gracely Scale; 0-35). Baseline was defined as the week prior to randomization. The greater the percent change, the bigger the reduction in pain intensity.|1st week of maintenance period (week prior to hospital admission for nested study; subjects traveled to Boston on days 6-7 of the maintenance period)||||Percent change from baseline||Standard Error|Mean
2676920|NCT01435772|Secondary|Insulin-like Growth Factor Binding Protein 3 (IGFBP3)|insulin-like growth factor binding protein 3 from lab|Baseline, Week 144|Full Analysis Set. No data collected for outcomes with 0 participants analyzed. Please note: the overall number of participants reflects the number of patients in that arm, while the outcome measurement number of participants reflects the number of patients for which data is available and analyzed.|||nmol/L||Standard Deviation|Mean
2676921|NCT01435772|Secondary|Plasma IGF-II Concentration|Plasma IGF-II concentration from lab|Baseline, Week 144|Full Analysis Set. No data collected for outcomes with 0 participants analyzed. Please note: the overall number of participants reflects the number of patients in that arm, while the outcome measurement number of participants reflects the number of patients for which data is available and analyzed.|||nmol/L||Standard Deviation|Mean
2676922|NCT01435772|Secondary|Plasma IGF-I Concentration|Plasma IGF-I concentration from lab|Baseline, Week 144|Full Analysis Set. No data collected for outcomes with 0 participants analyzed. Please note: the overall number of participants reflects the number of patients in that arm, while the outcome measurement number of participants reflects the number of patients for which data is available and analyzed.|||nmol/L||Standard Deviation|Mean
2676923|NCT01435772|Secondary|Change From Baseline in Urine Tetrasaccharide Concentration at Week 144|Change from Baseline in Urine Tetrasaccharide Concentration at Week 144|Baseline, Week 144|Full Analysis Set. No data collected for outcomes with 0 participants analyzed.|||mmol/mol||Standard Deviation|Mean
2676924|NCT01435772|Secondary|Percent Predicted Upright Forced Vital Capacity (FVC)|Pulmonary function test: Percent Predicted Upright Forced Vital capacity|Baseline, Week 144|Full Analysis Set.|||Percent Predicted||Standard Deviation|Mean
2676925|NCT01435772|Secondary|Percent Predicted Upright Forced Vital Capacity (FVC)|Pulmonary function test: Percent Predicted Upright Forced Vital Capacity|Baseline, Week 144|Full Analysis Set.|||Percent Predicted||Standard Deviation|Mean
2676926|NCT01435772|Secondary|Maximum Voluntary Ventilation (MVV)|Pulmonary function test: Maximum Voluntary Ventilation (MVV)|Baseline, Week 144|Full Analysis Set. No data collected for outcomes with 0 participants analyzed.|||L/min||Standard Deviation|Mean
2676927|NCT01435772|Secondary|6 Minutes Walk Test (Meters)|Distance walked within 6 minutes|Baseline, Week 144|Full Analysis Set.|||meter||Standard Deviation|Mean
2676928|NCT01435772|Secondary|Percent Predicted Maximum Expiratory Pressure (MEP)|Pulmonary Function Test: Percent Predicted Maximum Expiratory Pressure|Baseline, Week 144|Full Analysis Set. No data collected for outcomes with 0 participants analyzed.|||Percent of Predicted||Standard Deviation|Mean
2676929|NCT01435772|Secondary|Percent Predicted Maximal Inspiratory Pressure (MIP)|Pulmonary Function Test: Percent Predicted Maximal Inspiratory Pressure|Baseline, Week 144|Full Analysis Set. No data collected for outcomes with 0 participants analyzed.|||Percent of Predicted||Standard Deviation|Mean
2676930|NCT01435772|Primary|Number of Participants With a Positive Anti-BMN 701 Antibody Response|Status of Anti-IGF-II antibody is corresponding to the test results of blood samples|Baseline, Week 144|Full Analysis Set.|||Participants|||Count of Participants
2676931|NCT01435772|Primary|Number of Participants With a Positive Anti-BMN 701 Antibody Response|Status of Anti-IGF-I antibody is corresponding to the test results of blood samples|Baseline, Week 144|Full Analysis Set.|||Participants|||Count of Participants
2676932|NCT01435772|Primary|Number of Participants With a Positive Anti-BMN 701 Antibody|Status of Anti-BMN 701 antibody is corresponding to the test results of blood samples.|Baseline, Week 144|Full Analysis Set. Please note the overall number of participants reflects the number of patients in that arm, while the outcome measurement number of participants reflects the number of patients for which data is available and analyzed.|||Participants|||Count of Participants
2676933|NCT01435759|Primary|Change in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score From Augmentation Baseline (Week 8) to Week 16 (Double-blind Phase, Dose Response Evaluable Set)|MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. CHange in MADRS total score in Augmentsion Baseline to Week 16.|Augmentation Baseline (Week 8) to Week 16|Dose Response Evaluable Set (DRES): All randomized subjects who had at least 1 valid primary efficacy measurement (MADRS total score) during the Dose Maintenance Period (Weeks 11-16) while on the target dose level of investigational product.|||units on a scale||90% Confidence Interval|Least Squares Mean
2676934|NCT01435759|Secondary|Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16||From Augmentation Baseline (Week 8) to Week 16|Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product.|||bpm||Standard Deviation|Mean
2676935|NCT01435759|Secondary|Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16||From Augmentation Baseline (Week 8) to Week 16|Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product.|||mmHg||Standard Deviation|Mean
2676936|NCT01435759|Secondary|Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16||From Augmentation Baseline (Week 8) to Week 16|Vital Signs Evaluable Set: All randomized subjects who had at least 1 valid vital signs measurement during the Dose Maintenance Period while on the target dose level of investigational product.|||mmHg||Standard Deviation|Mean
2676937|NCT01435655|Other Pre-specified|Plasma Concentration of Tafamidis at Week 8, Week 26, Week 52 and Week 78|Mean plasma concentration of tafamidis at 3 hours after administration|Week 8, Week 26, Week 52, Week 78|The PK Analysis Set included all participants treated who had at least 1 quantifiable plasma tafamidis concentration.|||ng/mL||Standard Deviation|Mean
2676938|NCT01435655|Secondary|Number of Participants With Transthyretin (TTR) Stabilization at Week 26, Week 52, and Week 78 Compared With Baseline as Measured by a Validated Immunoturbidimetric Assay|"TTR tetramer was assessed using a validated immunoturbidimetric assay. The TTR tetramer level for each plasma sample was measured before and after urea denaturation. The Fraction of Initial (FOI) tetramer concentration is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI. A patient who has the TTR stabilization is defined as the patient whose percent stabilization is equal to or more than 32%."|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.|||Participants|||Number
2676939|NCT01435655|Secondary|Change From Baseline in Ambulatory Status at Week 26, Week 52 and Week 78|Ambulatory status was evaluated using walking ability scale in polyneuropathy disability score. The ambulatory status was evaluated as: 0=Good, 1=Sensory disturbances in the feet but able to walk without difficulty, 2=Some difficulties with walking but can walk without aid, 3a=Able to walk with 1 stick or crutch, 3b=Able to walk with 2 sticks or crutches, 4=Not ambulatory, confined to a wheelchair or bedridden.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.|||Participants|||Number
2676940|NCT01435655|Secondary|Change From Baseline in Modified Body Mass Index (mBMI) at Week 8, Week 26, Week 52 and End of Study|The mBMI was calculated by multiplying the BMI (the weight in kilograms divided by the square of the height in meters) by serum albumin level (gram/liter). Change in mBMI was calculated as the mBMI at the given week minus the Baseline mBMI.|Baseline, Week 8, Week 26, Week 52, End of Study|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.|||(kilogram/square meter)*(gram/liter)||Standard Deviation|Mean
2676941|NCT01435655|Secondary|Change From Baseline in Summated 3 Nerve Tests Small Fiber Normal Deviate Score (∑ 3 NTSF Nds) as Measured by Cooling and Heat Pain Thresholds by QST and HRDB at Week 26, Week 52 and Week 78|The Σ3 NTSF nds measures small-fiber function. It is a composite score defined as 3 times the mean of non-missing values of normal deviates of cooling threshold for lower limbs, heat pain intermediate response for lower limbs, and HRDB. The total score range is approximately -11.2 to 11.2, with a higher score demonstrating worse nerve function.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.|||Units on a scale||Standard Deviation|Mean
2676942|NCT01435655|Secondary|Change From Baseline in Summated 7 Nerve Tests Normal Deviate Score (∑ 7 NTs Nds) as Measured by Nerve Conduction Studies (NCS), Vibration Detection Threshold (VDT) and Heart Rate Response to Deep Breathing (HRDB) at Week 26, Week 52, and Week 78|The Σ7 NTs nds measures primarily large-fiber function. It is a composite score derived from five NCS attributes (peroneal nerve distal motor latency, peroneal nerve compound muscle action potential, peroneal nerve motor conduction velocity, tibial nerve distal motor latency, and sural nerve sensory nerve action potential amplitude) along with VDT obtained in great toes by Quantitative Sensory Testing (QST), and HRDB value. It is defined as 7 times the mean of non-missing values of, the five normal deviates of NCS, HRDB, and average normal deviate for VDT of toes. Score was determined through reference to normal values for age, sex, height and abnormalities scored. Total score range is approximately -26 to 26, where higher score=worse nerve function.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.|||Units on a scale||Standard Deviation|Mean
2676943|NCT01435655|Secondary|Change From Baseline in Scores of the Total Quality of Life (TQOL) and 5 Domains as Measured by the Norfolk QOL - Diabetic Neuropathy (Norfolk QOL-DN) at Week 26, Week 52 and Week 78.|Norfolk QOL-DN is a 35-item participant-rated questionnaire. It consists of 5 domains: Physical Functioning/Large Fiber [score range: -4 - 56] , Activities of Daily Living (ADL) [0 - 20], Symptoms [0 - 32], Small Fiber [0 - 16] and Autonomic [0 - 12]. Total of quality of life (TQOL) score is the sum of all five domains with a range of -4 to 136 (Pfizer Data Standards). Higher scores on each item of the Norfolk QOL-DN TQOL indicate worse quality of life.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.|||Units on a scale||Standard Deviation|Mean
2676944|NCT01435655|Secondary|Change From Baseline in Neuropathy Impairment Score (NIS); NIS (Total), NIS-LL (Lower Limb) and NIS-UL (Upper Limb) at Week 26, Week 52 and Week 78|The NIS provides a total body single score of neuropathic deficits (score range: 0-122, higher score = more deficit), comprising subset scores for cranial nerves, muscle weakness, reflexes, and sensation (based on mean of 2 scores in 1 week period; each item scored separately for left and right). The NIS-LL is a subscale that provides a score for the lower limbs functions (muscle weakness, reflexes and sensation in great toe) and has a score range of 0-44 (higher score = more deficit). The NIS-UL is a subscale that provides a score for the upper body functions (muscle weakness [including cranial nerves], reflexes and sensation in finger) and has a score range of 0-78 (higher score = more deficit). The components for cranial nerves and muscle weakness are scored from 0 (Normal) to 4 (Paralysis), and those for reflexes and sensation from 0 (Normal) to 2 (Absent). For all items, higher scores indicate greater impairment.|Baseline, Week 26, Week 52, Week 78|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.|||Units on a scale||Standard Deviation|Mean
2676945|NCT01435655|Primary|Number of Participants With Transthyretin (TTR) Stabilization at Week 8 Compared With Baseline as Measured by a Validated Immunoturbidimetric Assay|"TTR tetramer level for each plasma sample was assessed using a validated immunoturbidimetric assay before and after urea denaturation. The Fraction of Initial (FOI) tetramer concentration is the ratio of the measured TTR tetramer concentration after denaturation to the measured TTR tetramer average concentration before denaturation. TTR tetramer stabilization is based on the difference between the on-treatment FOI and the baseline FOI expressed as a percentage of the baseline FOI. A patient who has the TTR stabilization is defined as the patient whose percent stabilization is equal to or more than 32%."|8 weeks|Full Analysis Set (FAS) included all participants who received at least one dose of the study drug.|||Participants|||Number
2676946|NCT01435616|Secondary|Percentage of Participants With Equal or Above 2- and 3-fold ULN for Alanine Transaminase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) and Aspartate Transaminase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)|The percentage of participants was calculated by dividing the number of participants equal or above 2- or 3-fold ULN for ALT/SGPT or AST/SGOT by the total number of participants analyzed, multiplied by 100.|Up to 52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable post-baseline liver enzyme data.|||percentage of participants|||Number
2676947|NCT01435616|Secondary|Percentage of Participants With HbA1C Equal or Less Than 6.5% and Less Than 7.0 % and Without Nocturnal Hypoglycemia|The percentage of participants with HbA1C ≤ 6.5% or < 7.0% without nocturnal hypoglycemia is presented. Percentage was calculated by dividing the number of participants with the indicated HbA1c values over the total number of participants and multiplying by 100.|Up to 52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline HbA1c measurement. Missing endpoints were imputed with the LOCF method, using only post-baseline data.|||percentage of participants|||Number
2676948|NCT01435616|Secondary|Percentage of Participants With Total and Nocturnal Hypoglycemic Events|A hypoglycemic event is defined by a blood glucose value ≤70 mg/dL (3.9mmol/L). Total hypoglycemic events include documented symptomatic hypoglycemia, asymptomatic hypoglycemia, probable symptomatic hypoglycemia, unspecified hypoglycemia, or severe hypoglycemia. Nocturnal hypoglycemic events refer to any total hypoglycemic event that occurs between bedtime and waking. The percentage of participants was calculated by dividing the number of participants with hypoglycemic or nocturnal hypoglycemic events by the total number of participants analyzed, multiplied by 100.|Baseline to 52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable hypoglycemia event data.|||percentage of participants|||Number
2676949|NCT01435616|Secondary|Intra-participant Variability of the Fasting Blood Glucose (FBG)|Intra-participant variability of FBG, which was measured by SMBG, was assessed by the standard deviation of the FBG measurement at the Week 52 visit. LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable post-baseline FBG data.|||mg/dL||Standard Error|Least Squares Mean
2676950|NCT01435616|Secondary|Overall Treatment-Emergent Anti-LY2065541 Antibody Response (TEAR)|The percentage of participants with a TEAR is summarized. TEAR is defined as a change in the anti-LY2605541 antibody level from undetectable at baseline to detectable at baseline, or, for those participants with detectable antibodies at baseline, change to a value with at least a 130% relative increase from baseline. Overall TEAR is defined as one or more TEAR during the specified period.|Baseline to 78 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable TEAR data.|||percentage of participants|||Number
2676951|NCT01435616|Secondary|Percentage of Participants With Equal or Above 2-, and 3-fold Upper Limits of Normal (ULN) for Total Bilirubin||Up to 52 weeks|All participants who were randomized, had at least 1 dose of study drug, and had at least 1 post-baseline total bilirubin measurement.|||percentage of participants|||Number
2676952|NCT01435616|Secondary|Change From Baseline to 52 Weeks in Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)|LS means were calculated using a MMRM with baseline lipid measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|Baseline, 52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline lipid measurement.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2676953|NCT01435616|Secondary|Adult Low Blood Sugar Survey|The adult Low Blood Sugar Survey (LBSS) is a validated, participant-reported 33-item questionnaire with items rated on a 5-point Likert scale, where 0 = never and 4 = always. The LBSS measures behaviors to avoid hypoglycemia and its negative consequences (15 items) and worries about hypoglycemia and its negative consequences (18 items). Total score is the sum of all items (range of 0 to 132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using an analysis of covariance model (ANCOVA) with baseline LBSS score, stratification factors (country, HbA1c, and SU/meglitinide use), and treatment as fixed effects.|Up to 52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable LBSS data. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.|||units on a scale||Standard Error|Least Squares Mean
2676954|NCT01435616|Secondary|Insulin Treatment Satisfaction Questionnaire|The Insulin Treatment Satisfaction Questionnaire (ITSQ) is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes who are receiving insulin. The questionnaire measures satisfaction from the following 5 domains: inconvenience of regimen, lifestyle flexibility, glycemic control, hypoglycemic control, and insulin delivery device. Data presented are the transformed total score on a scale of 0 to 100, where higher scores indicate better treatment satisfaction. LS means were calculated using a MMRM with stratification factors (country, HbA1c, and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|Up to 52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable ITSQ data.|||units on a scale||Standard Error|Least Squares Mean
2676955|NCT01435616|Secondary|European Quality of Life-5 Dimension (EQ-5D)|The EQ-5D is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) using a 3-level scale of 1 to 3 (no problem, some problems, and extreme problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United States population-based algorithm. Scores range from -0.11 to 1.0, where a score of 1.0 indicates perfect health. LS means were calculated using a MMRM with baseline stratification factors (country, HbA1c, and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable EQ-5D data.|||units on a scale||Standard Error|Least Squares Mean
2676956|NCT01435616|Secondary|Number of Insulin Dose Adjustments to Steady-State|Insulin doses were adjusted according to an algorithm (adapted from Riddle et al. 2003) during the first 26 weeks of the study and thereafter according to investigator judgment. Steady-state was defined as the first local maximum dose (maximum of moving 4-week interval) of LY2605541 or glargine within the window of +/- 2 weeks. The number of dose adjustments to steady-state was the total number of dose changes until steady-state was reached. LS means were calculated using a MMRM with baseline insulin dose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|Baseline to 52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable post-baseline insulin data.|||number of insulin dose adjustments||Standard Error|Least Squares Mean
2676957|NCT01435616|Secondary|Insulin Dose Per Body Weight|LS means were calculated using a MMRM with baseline insulin dose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable insulin dose data.|||units of insulin/kg body weight||Standard Error|Least Squares Mean
2676958|NCT01435616|Secondary|Hemoglobin A1c|HbA1c is a test that measures a person's average blood glucose level over the past 2 to 3 months. LS means were calculated using a MMRM with baseline HbA1C measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline HbA1c measurement.|||percentage of HbA1c||Standard Error|Least Squares Mean
2676959|NCT01435616|Secondary|Change From Baseline to 52 Weeks in Body Weight|LS means were calculated using a MMRM with baseline body weight measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|Baseline, 52 weeks|All participants who were randomized, who received at least 1 dose of study drug, and had evaluable body weight data.|||kilograms (kg)||Standard Error|Least Squares Mean
2676960|NCT01435616|Secondary|6 Point Self-monitored Blood Glucose (SMBG)|Six-point SMBG profiles were obtained at pre-morning meal (fasting), pre-midday meal (lunch), pre-evening meal (dinner), bedtime, approximately 0300 hours, and pre-morning meal (fasting) the next day. Six-point SMBG profiles were obtained over 2 nonconsecutive days within the week prior to the next office visit. LS means were calculated using a MMRM with baseline blood glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable SMBG data.|||mg/dL||Standard Error|Least Squares Mean
2676961|NCT01435616|Secondary|Fasting Blood Glucose (By Participant Self-monitored Blood Glucose Readings)|LS means were calculated using a MMRM with baseline fasting blood glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable fasting blood glucose data.|||mg/dL||Standard Error|Least Squares Mean
2676962|NCT01435616|Secondary|Fasting Serum Glucose (By Laboratory Measurement)|LS means were calculated using a MMRM with baseline fasting serum glucose measurement, stratification factors (country, HbA1c, LDL-C [< 100 mg/dL and ≥ 100 mg/dL], and SU/meglitinide use), treatment, visit, and treatment-by-visit interaction as fixed effects.|52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had evaluable fasting serum glucose data.|||mg/dL||Standard Error|Least Squares Mean
2676963|NCT01435616|Secondary|Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 %|The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.|52 weeks|All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline HbA1c measurement.|||percentage of participants|||Number
2676981|NCT01435577|Secondary|Time to Perceptible Pain Relief|When the participant began to feel any pain-relieving effect after the administration of the first dose they were requested to stop the first stopwatch. The time was noted. This measured when the participant first felt any difference in the pain.|up to 48 hours|Participants without pain relief (as measured by the double stopwatch method) were censored at 12 hours from the initial dose or at the time of early withdrawal from the Double-blind Treatment Period, whichever occurred first. Time to perceptible pain relief is not reported for matching placebo arms because of the high number of discontinuations.|||hours||95% Confidence Interval|Median
2676964|NCT01435616|Secondary|Rate of Total and Nocturnal Hypoglycemia Events|Hypoglycemia is a condition that occurs when a person's blood glucose level is lower than the normal range (less than or equal to 70 milligrams per deciliter [mg/dL] or less than 3.9 millimoles per liter [mmol/L]). Total hypoglycemia refers to an event that meets the criteria for documented symptomatic hypoglycemia, asymptomatic hypoglycemia, probable symptomatic hypoglycemia, unspecified hypoglycemia, or severe hypoglycemia. Nocturnal hypoglycemia refers to any total hypoglycemic event that occurs between bedtime and waking. Group mean (listed as LS means below) rates of total and nocturnal hypoglycemia were calculated using a negative binomial regression model (number of episodes = treatment + SU/meglitinide use + baseline hypoglycemia event rate, with log [exposure per 30 days] as the offset variable in the model).|Baseline to 52 weeks|All participants who were randomized, who received at least 1 dose of study drug, and had evaluable total and/or nocturnal event data.|||episodes/participant/30 days||Standard Error|Least Squares Mean
2676965|NCT01435616|Primary|Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c)|HbA1C is a test that measures a person's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) with baseline HbA1c measurement, stratification factors (country, low density lipoprotein-cholesterol [LDL-C, < 100 milligrams per deciliter {mg/dL} and ≥ 100 mg/dL] and sulfonylurea [SU]/meglitinide use), visit, treatment, and visit-by-treatment interaction as fixed effects.|Baseline, 52 weeks|All participants who were randomized, had at least 1 dose of study medication, and at least 1 post-baseline HbA1c measurement.|||percentage of HbA1c||Standard Error|Least Squares Mean
2676966|NCT01435603|Secondary|Percent Change in Physical Activity||Baseline to 6, 12, and 24 months|||||||
2676967|NCT01435603|Secondary|Percent Change in Dietary Composition||Baseline to 6, 12, and 24 months|||||||
2676968|NCT01435603|Secondary|Percent Change in Blood Pressure||Baseline to 6, 12, and 24 months|||||||
2676969|NCT01435603|Secondary|Percent Change in A1c||Baseline to 6, 12, and 24 months|||||||
2676970|NCT01435603|Secondary|Percent Change in Blood Total Cholesterol||Baseline to 6, 12, and 24 months|||||||
2676971|NCT01435603|Secondary|Percent Change in Body Weight||Baseline to 6 and 24 months|||||||
2676972|NCT01435603|Secondary|Changes in Health State Utility|The study collects individual participant survey data that will include the Medical Outcomes Study Short Form-12 health-related quality of life questionnaire. Responses from the questionnaire are used to construct a validated numerical score that expresses global health-related quality of life across a range of 0 (death) to 1 (perfect health). Changes in this indicator will be evaluated.|Baseline to 6,12, and 24 months|||||||
2676973|NCT01435603|Secondary|Incremental Costs|The study will capture direct medical, direct non-medical, and indirect costs from individual participants. Mean changes in these costs will be compared across randomized study arms.|6, 12, and 24 months|||||||
2676974|NCT01435603|Primary|Percent Change in Body Weight|(Body weight at 12 months subtracted from baseline body weight) divided by baseline body weight. Negative numbers indicate a weight loss.|Baseline to 12 months|Participants who completed weight measurements at the baseline and 12 month exam|||percentage of change||Standard Deviation|Mean
2676975|NCT01435577|Secondary|Mean Pain Intensity Scores at Relative Time - Matching Placebo Randomized Participants|The pain intensity at the relative time points are the pain intensity before and one hour after study drug administration. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.|Baseline; for the first 6 administrations|Participants contributing data (indicated in brackets)|||units on a scale||Standard Deviation|Mean
2676976|NCT01435577|Secondary|Mean Pain Intensity Scores at Relative Time- Tapentadol Randomized Participants|The pain intensity at the relative time points are the pain intensity before and one hour after study drug administration. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.|Baseline; for the first 6 administrations|Participants contributing data.|||units on a scale||Standard Deviation|Mean
2676977|NCT01435577|Secondary|Pharmacokinetic Concentrations of Tapentadol-O-glucuronide|"Tapentadol-O-glucuronide is the metabolite of tapentadol. Metabolites are sometimes referred to as breakdown products. The body alters the administered medication to a metabolite so that can be more easily or quickly removed from the body. Tapentadol-O-glucuronide concentrations were measured in participants in the tapentadol treatment arm. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL."|15 minutes to 20 hours after first drug administration|Participants in the placebo arm were not analyzed. Only those participants contributing data were analyzed. Participants that had an early second study drug administration were not part of the analysis.|||ng/mL||Full Range|Mean
2676978|NCT01435577|Post-Hoc|Number of Participants Scored as a Responder Based on Patient Global Impression of Change|"Responders are those participants with Patient Global Impression of Change (PGIC) values Much improved, or Very much improved. Participants with missing value are considered non-responders."|Fixed time points at 12, 24 and 48 hours after baseline|Participants with early second dose the PGIC assessment from End-of-double-blind Treatment was taken as the 48 hours value. Assessments done more than 4.5 hours after the 12th infusion were excluded from analysis and participants were considered non-responders.|||participants|||Number
2676979|NCT01435577|Secondary|Pharmacokinetic Concentrations of Tapentadol|Tapentadol concentrations were measured in participants in the tapentadol treatment arm. Serum was analyzed by means of liquid chromatography coupled to tandem mass spectrometry with a lower limit of quantification (LLOQ) at 0.2 ng/mL.|15 minutes to 20 hours after first drug administration|Participants in the placebo arm were not analyzed. Only those participants contributing data were analyzed. Participants that had an early second study drug administration were not part of the analysis.|||ng/mL||Full Range|Mean
2676980|NCT01435577|Secondary|Time to Meaningful Pain Relief|The participant was instructed to stop the stopwatch when they had meaningful pain relief. That is, when the pain relief made a real difference, after the first drug administration.|up to 48 hours|Participants without pain relief (as measured by the double stopwatch method) were censored at 12 hours from the initial dose or at the time of early withdrawal from the Double-blind Treatment Period, whichever occurred first. Time in hours to meaningful pain relief are not reported for matching placebo arm due to the high discontinuation rate.|||hours||95% Confidence Interval|Median
2676984|NCT01435577|Secondary|Number of Participants With 50% Response After 24 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 24 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.|Baseline value to 24 hours after first study drug administration|Full analysis set.|||participants|||Number
2676985|NCT01435577|Secondary|Number of Participants With 50% Response After 12 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 50% or more reduction in pain intensity from the administration of the first dose to 12 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 50% from their baseline value.|Baseline value to 12 hours after first study drug administration|Full analysis set.|||participants|||Number
2676986|NCT01435577|Secondary|Number of Participants With 30% Response After 48 Hours, Based on Pain Intensity Scores|Individual participants response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 48 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.|Baseline value to 48 hours after first study drug administration|Full analysis set.|||participants|||Number
2676987|NCT01435577|Secondary|Number of Participants With 30% Response After 24 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 24 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.|Baseline value to 24 hours after first study drug administration|Full analysis set.|||participants|||Number
2676988|NCT01435577|Secondary|Number of Participants With 30% Response After 12 Hours, Based on Pain Intensity Scores|Individual participant response. Number of participants that reported a 30% or more reduction in pain intensity from the administration of the first dose to 12 hours after the first study drug administration are counted as having a response if their pain intensity decreased by 30% from their baseline value.|Baseline value to 12 hours after first study drug administration|Full analysis set.|||participants|||Number
2676989|NCT01435577|Secondary|Sum of Pain Intensity Differences After 48 Hours|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 60 minutes was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).|Baseline value to 48 hours after first study drug administration|Full Analysis Set.|||units on a scale||95% Confidence Interval|Mean
2676990|NCT01435577|Secondary|Sum of Pain Intensity Differences After 12 Hours|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 12 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).|Baseline value to 12 hours after first study drug administration|Full Analysis Set.|||units on a scale||95% Confidence Interval|Mean
2676991|NCT01435577|Secondary|Sum of Pain Intensity Differences After 8 Hours|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 8 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).|Baseline value to 8 hours after first study drug administration|Full Analysis Set.|||units on a scale||95% Confidence Interval|Mean
2676992|NCT01435577|Secondary|Sum of Pain Intensity Differences After 4 Hours|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 4 hours was calculated. If the values are negative (then the baseline pain intensity was greater than the pain intensity measured after dosing).|Baseline value to 4 hours after first study drug intake|Full analysis set. Primary imputation method was analyzed: Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 h after each rescue medication intake.|||units on a scale||95% Confidence Interval|Mean
2676993|NCT01435577|Secondary|Sum of Pain Intensity Differences After 60 Minutes|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between the PI after fixed times after first dose and the baseline PI (prior to the first dose). The Sum of Pain Intensity Differences over 60 minutes was calculated. If the value is negative then the baseline pain intensity was greater than the pain intensity measured after dosing.|Baseline value to 60 minutes after first study drug administration|Full analysis set.|||units on a scale||95% Confidence Interval|Mean
2676994|NCT01435577|Secondary|Patient Global Impression of Change After 48 Hours of Treatment|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).|Baseline value to 48 hours after first study drug administration|Participants contributing data. Missing PGIC values were mainly due to participants discontinuing the trial before this time point.|||participants|||Number
2676995|NCT01435577|Secondary|Patients Global Impression of Change After 24 Hours of Treatment|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).|Baseline value to 24 hours after study drug administration|Participants contributing data. Missing PGIC values were mainly due to participants discontinuing the trial before this time point.|||participants|||Number
2676996|NCT01435577|Secondary|Patient Global Impression of Change After 12 Hours of Treatment|In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant verbally rated their impression of overall status with 1 of 7 possible responses (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse).|Baseline value to 12 hours after first study drug administration|Participants contributing data. Missing PGIC values were mainly due to participants discontinuing the trial before this time point.|||participants|||Number
2676997|NCT01435577|Secondary|Pain Intensity Differences at Fixed Time Points|Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline pain intensity (prior to the first dose) and the pain intensity at the time. A negative number indicates a decrease in pain in the whole treatment group. The greater the negative pain intensity difference value the greater the pain relief in the treatment arm. A score of 0 indicates that there has been no change in pain in a treatment group. A positive value indicates an increase in pain in the treatment group.|Starting at 15 minutes and up to 48 hours after first drug administration|Full Analysis Set (FAS): Participants who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 hours after each rescue medication intake.|||units on a scale||Standard Deviation|Mean
2676998|NCT01435577|Secondary|Mean Pain Intensity Scores at Fixed Time Points|The mean pain intensity at fixed time points in the trial for all participants is listed. The pain intensity was measured using the Pain Intensity (PI). Pain intensity was assessed on 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine.|Baseline; up to 48 hours|Full Analysis Set (FAS). Participants who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 hours after each rescue medication intake.|||units on a scale||Standard Deviation|Mean
2676999|NCT01435577|Primary|Sum of Pain Intensity Differences (SPID 24)|"Pain Intensity assessed at predefined time points (at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours after first drug administration) over a 24 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates no pain and a score of ten indicates pain as bad as you can imagine. Pain Intensity Differences at each predefined time point (calculated as post-baseline NRS values - baseline NRS values) were analyzed. Negative SPID24 values indicate a decrease in pain intensity and positive values indicate an increase in pain intensity since baseline."|Baseline value; up to 24 hours after first study drug administration|Full Analysis Set (FAS): patients who took at least one dose of study medication, had a baseline value, and had at least one post-baseline measurement; Last Observation Carried Forward (LOCF) after dropout, and LOCF for 6 hours after each rescue medication intake.|||units on a scale||95% Confidence Interval|Least Squares Mean
2677000|NCT01435460|Secondary|Ocular Itching|Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe|Change from baseline to day 8 (visit 2)|Participants analyzed from the per protocol (PP) population|||units on a scale||Standard Deviation|Mean
2677001|NCT01435460|Secondary|Bulbar Conjunctival Injection|Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe|Change from baseline to day 8 (visit 2)|Participants analyzed from the per protocol (PP) population|||units on a scale||Standard Deviation|Mean
2677002|NCT01435460|Primary|Ocular Itching|Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe|Change from baseline to day 15 (visit 3)|Participants analyzed from the per protocol (PP) population|||units on a scale||Standard Deviation|Mean
2677003|NCT01435460|Primary|Bulbar Conjunctival Injection|Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe|Change from baseline to day 15 (visit 3)|Participants analyzed from the per protocol (PP) population|||units on a scale||Standard Deviation|Mean
2677004|NCT01435382|Other Pre-specified|Percentage of Participants With Positive Anti-drug (Anti-PF 04950615) Antibodies|Human serum samples of participants who received PF-04950615 were analyzed for the presence of anti-PF-04950615 antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA).|Day 1 up to Day 85|Safety analysis set included all participants who had at least 1 dose of study medication.|||percentage of participants|||Number
2677005|NCT01435382|Other Pre-specified|Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)|ECG abnormalities included 1) PR interval: maximum >=300 maximum millisecond (msec), increase of >=25 percent (%) for baseline value of >200 msec and maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec; 2) QRS interval: maximum >=200 msec, maximum increase of >=25 % for baseline value of >100 msec and maximum increase of >=50% for baseline value of <=100 msec; 3) QT interval corrected using the Fridericia's formula (QTCF): 450 msec to <= 480 msec, 480 msec to <=500 msec, > 500 msec, maximum increase from baseline of >30 to <=60 msec and maximum increase from baseline of >60 msec. Clinical significance of ECG were judged by investigator.|Day 1 up to Day 85|Safety analysis set included all participants who had at least 1 dose of study medication.|||Participants|||Count of Participants
2677006|NCT01435382|Other Pre-specified|Number of Participants With Clinically Significant Changes in Vital Signs|Vital signs abnormalities included: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (>=) 30 millimeter of mercury (mmHg); maximum increase or decrease from baseline in supine diastolic BP of >=20 mmHg; supine pulse rate less than (<) 40 beats per minute (bpm) and greater than (>) 120 bpm; standing pulse rate less than (<) 40 beats per minute (bpm) and greater than (>) 140 bpm. Clinical significance of vital signs were judged by investigator.|Day 1 up to Day 85|Safety analysis set included all participants who had at least 1 dose of study medication.|||Participants|||Count of Participants
2677030|NCT01435356|Primary|Disease Free Survival|To evaluate of the clinical efficacy in terms of Disease Free Survival of treatment versus placebo in the overall population of patients with bladder cancer with MAGE-A3 expression after cystectomy. Disease Free Survival is the time from randomization to either the date of first recurrence of the disease or the date of death (whatever the cause), whichever occurred first. Types of recurrence considered as an event included loco-regional and distant metastases. In addition, any death occurring without prior documentation of tumor recurrence was considered as an event (and was not censored in the statistical analysis) as this approach is less prone to introduce bias.|5 years||||months||95% Confidence Interval|Mean
2677007|NCT01435382|Other Pre-specified|Number of Participants With Clinically Significant Laboratory Abnormalities|Laboratory parameters evaluated for abnormalities were: hematology (hemoglobin [Hgb], hematocrit, red blood cell [RBC] count, platelets, white blood cell count [WBC], lymphocytes, total neutrophils, basophils, eosinophils, monocytes); coagulation (partial thromboplastin time, prothrombin time [PT], PT international ratio); clinical chemistry (glucose, creatine kinase, amylase, lipase); liver function (total, direct and indirect bilirubin, aspartate aminotransferase [AT], alanine AT, gamma-glutamyl transferase, alkaline phosphatase, total protein, albumin, lactate dehydrogenase); renal function (blood urea nitrogen, creatinine, uric acid); urinalysis (urine- specific gravity, pH, glucose, ketones, blood/Hgb, nitrite, leukocyte, esterase, RBC, WBC, epithelial cells, hyaline cast and bacteria); lipid (cholesterol); electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate, bicarbonate). Clinical significance of laboratory abnormalities were judged by investigator.|Day 1 up to Day 85|Safety analysis set included all participants who had at least 1 dose of study medication.|||Participants|||Count of Participants
2677008|NCT01435382|Other Pre-specified|Visual Analogue Scale (VAS)|Participants indicated the amount of pain experienced due to study drug injection, on a VAS of 0 (no pain) to 100 (very severe pain), where higher scores indicate higher intensity of pain.|Day 1: Immediately post-dose, 0.5, 1.0, 2.0, 8.0 hours post-dose; Day 2, 3|Safety analysis set included all participants who had at least 1 dose of study medication. Here, “Number of Participants Analyzed” signifies number of participants evaluable at different time points.|||units on a scale||Standard Deviation|Mean
2677009|NCT01435382|Other Pre-specified|Number of Injection Site Reactions Reported as Adverse Events|The injection site reactions included erythema, induration, ecchymosis, injection site pain and injection site pruritus. An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|Day 1 up to Day 3|Safety analysis set included all participants who had at least 1 dose of study medication. This outcome measure was planned not to be analyzed in reporting arm: PF-04950615 200 mg IV.|||injection site reactions|||Number
2677010|NCT01435382|Other Pre-specified|Number of Participants With Injection Site Reactions|The injection site reaction included erythema, induration, ecchymosis, injection site pain, injection site pruritus.|Day 1 up to Day 3|Safety analysis set included all participants who had at least 1 dose of study medication. This outcome measure was planned not to be analyzed in reporting arm: PF-04950615 200 mg.|||Participants|||Count of Participants
2677011|NCT01435382|Other Pre-specified|Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Day 1 up to Day 85|Safety analysis set included all participants who had at least 1 dose of study medication.|||Participants|||Count of Participants
2677012|NCT01435382|Other Pre-specified|Number of Adverse Events (AEs) by Severity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).|Day 1 up to Day 85|Safety analysis set included all participants who had at least 1 dose of study medication.|||adverse events|||Number
2677013|NCT01435382|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state.|Day 1 up to Day 85|Safety analysis set included all participants who had at least 1 dose of study medication.|||Participants|||Count of Participants
2677014|NCT01435382|Secondary|Duration of Fasting LDL-C Suppressed Below 70 mg/dL and 100 mg/dL||Day 1 up to Day 85|PD population included all participants randomized and treated who had at least 1 plasma concentration of PF-04950615, and lipid panel or PCSK9 data. Here, “Number of Participants Analyzed” signifies number of participants evaluable at different time points.|||days||Standard Deviation|Mean
2677015|NCT01435382|Secondary|Percent Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C) at Day 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71 and 85|Baseline was the average of observations collected on Days 7 and 1 prior to the study treatment administration.|Baseline, Day 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85|PD population included all participants randomized and treated who had at least 1 plasma concentration of PF-04950615, and lipid panel or PCSK9 data. Here, “Number of Participants Analyzed” signifies number of participants evaluable at different time points.|||percent change||Standard Deviation|Mean
2677016|NCT01435382|Secondary|Absolute Value of Fasting Low-density Lipoprotein Cholesterol (LDL-C)||Day 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85|Pharmacodynamic (PD) population included all participants randomized and treated who had at least 1 plasma concentration of PF-04950615, and lipid panel or proprotein convertase subtilisin/kexin type 9 (PCSK9) data. Here, “Number of participants analyzed” signifies number of participants evaluable at different time points.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2677031|NCT01435304|Secondary|Number of Participants on Vasoactive Drugs at 48 Hours Post op Point|This metric is a surrogate for low output failure and /or vasoplegia depending upon whether inotropes or vasoconstrictors are used.|Any intravenous vasoactive drug being used at the 48 hour time point postoperative||||Participants|||Count of Participants
2677032|NCT01435304|Secondary|Number of Participants With Stroke|Any neurological defect according to Society of Thoracic Surgery (STS) definition|Index admission postoperative until the time of discharge, an expected average of 7 days.||||Participants|||Count of Participants
2677017|NCT01435382|Primary|Absolute Bioavailability of PF-04950615 Subcutaneous Groups|Bioavailability is defined as the rate and extent to which the active moiety administered drug reaches the systemic circulation. Absolute bioavailability of the subcutaneous doses was estimated by comparing log-transformed dose-normalized AUClast for subcutaneous to intravenous dose.|Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were evaluable for this measure. This outcome measure was not analyzed in reporting arm: PF‑04950615 IV 200 mg.|||percentage of bioavailability||95% Confidence Interval|Number
2677018|NCT01435382|Primary|Terminal Elimination Half-life (t1/2) of PF-04950615|t1/2 is the time measured for the plasma concentration of drug to decrease by one half.|Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were evaluable for this measure.|||hour||Standard Deviation|Mean
2677019|NCT01435382|Primary|Volume of Distribution at Steady State (Vss) of PF-04950615 Intravenous Group|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss is determined when overall intake of drug is in dynamic equilibrium with its elimination.|Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|PK parameter analysis population. Here 'N' signifies those participants who were evaluable for this measure. This outcome measure was planned not to be analyzed in reporting arms: PF-04950615 SC 200 mg (2 injections of 1mL), PF-04950615 SC 200 mg (1 injection of 2 mL) and PF-04950615 SC 100 mg (1 injection of 1 mL).|||milliliter||Standard Deviation|Mean
2677020|NCT01435382|Primary|Apparent Volume of Distribution (Vz/F) of PF-04950615 Subcutaneous Groups|Volume of distribution (Vz) is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction of the dose absorbed from plasma after SC administration of drug.|Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were evaluable for this measure. This outcome measure was planned not to be analyzed in reporting arm: PF‑04950615 IV 200 mg.|||milliliter||Standard Deviation|Mean
2677021|NCT01435382|Primary|Clearance (CL) of PF-04950615 Intravenous Group|Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.|Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|PK parameter analysis population. Here 'N' signifies those participants who were evaluable for this measure. This outcome measure was planned not to be analyzed in reporting arms: PF-04950615 SC 200 mg (2 injections of 1mL), PF-04950615 SC 200 mg (1 injection of 2 mL) and PF-04950615 SC 100 mg (1 injection of 1 mL).|||milliliter per hour||Standard Deviation|Mean
2677022|NCT01435382|Primary|Apparent Clearance (CL/F) of PF-04950615 Subcutaneous Groups|Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent clearance (CL/F) is influenced by the fraction of the dose absorbed from plasma after SC administration of drug.|Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were evaluable for this measure. This outcome measure was planned not to be analyzed in reporting arm: PF‑04950615 IV 200 mg.|||milliliter per hour||Standard Deviation|Mean
2677023|NCT01435382|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero To Infinity (AUCinf) of PF‑04950615||Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' signifies those participants who were evaluable for this measure.|||nanogram*hour per milliliter||Standard Deviation|Mean
2677024|NCT01435382|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of PF‑04950615||Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. Here 'N' (Overall Number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||nanogram*hour per milliliter||Standard Deviation|Mean
2677025|NCT01435382|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615||Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|PK parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest.|||hour||Full Range|Median
2677026|NCT01435382|Primary|Maximum Observed Plasma Concentration (Cmax) of PF‑04950615||Pre-dose, 30 minutes, 1, 8, 24, 48, 72, 96, 120, 168, 336, 504, 672, 840, 1008, 1176, 1344, 1512, 1680, 2016 hours post-dose|Pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who have at least 1 of the PK parameters of primary interest.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2677027|NCT01435356|Secondary|Distant Metastasis-free Survival|To evaluate Distant metastasis-free survival in the overall study population. Distant metastasis-free survival was defined as the interval from randomization to the date of first distant metastasis or date of death, whichever occurred first. Patients alive and without distant metastasis were censored at the date of last assessment.|5 years||||months||95% Confidence Interval|Mean
2677028|NCT01435356|Secondary|Disease-free Specific Survival|To evaluate Disease-free specific survival in the overall population.Disease-free specific survival was defined as the interval from randomization to the date of first recurrence of disease or date of death due to bladder carcinoma, whichever occurred first. Patients without recurrence or death were censored at the date of last assessment. Patients without recurrence who died from another cause were censored at the date of death.|5 years||||months||95% Confidence Interval|Mean
2677034|NCT01435304|Secondary|Number of Participants With Acute Kidney Injury (AKI)|Using the Acute Kidney Injury Network (AKIN) definition of a 0.03mg/dL increase in serum creatinine within 48 hours of surgery, serial postoperative creatinines will reflect the presence of AKI when compared with the baseline creatinine.|All creatinines will be recorded and assessed during the entire index admission in order to compare postoperative to preoperative baseline creatinine, an expected average of 7 days.||||Participants|||Count of Participants
2677035|NCT01435304|Secondary|Number of Participants Which Had Blood Products Transfused (RBC's, Platelets, FFP)|These blood components can be a metric of the success of achieving a satisfactory coagulation status.|All blood products transfused during index admission, an expected average of 7 days, with the exception of preoperative transfusions.||||Participants|||Count of Participants
2677036|NCT01435304|Primary|Amount of Chest Catheter Drainage 24 Hours Postoperatively|Chest catheters are placed in the mediastinum and sometimes pleural space(s) to collect shed mediastinal blood in the first 24 hours post operative cardiac surgery|Total amount for the first 24 hours postoperative||||mL||Standard Deviation|Mean
2677037|NCT01435265|Secondary|Adherence to Adalimumab Treatment|Adherence measured by average days between doses used, as measured by a Medication Event Monitoring System (MEMS) cap on the disposal container for used syringes.|Baseline to 12 months|All participants|||days||Standard Deviation|Mean
2677038|NCT01435265|Primary|Investigator's Global Assessment (IGA) of Psoriasis|Investigator's Global Assessment (IGA) is rated on a scale of 0 (clear) to 5 (very severe). The outcome measure to be reported is the number of patients who reached a final IGA of 0 (clear) or 1 (almost clear).|12 months|All participants completing the study.|||participants|||Number
2677039|NCT01435265|Primary|Change in Psoriasis Area Severity Index (PASI-75)|The Psoriasis Area Severity Index measures severity of psoriasis on a 0-6 scale for head, trunk, upper extremities, and lower extremities and amount of erythema, infiltration, and desquamation for each area. An overall score of 0-72 for the whole body is calculated from the observed severity values. Outcomes will be reported in terms of PASI 75, or number of participants showing at least 75% reduction in PASI score from baseline. Only final PASI 75 will be reported.|Baseline, 1 month, 3 months, 6 months, 9 months, 12 months|All participants who completed the study.|||participants|||Number
2677040|NCT01435174|Primary|Pharmacokinetic Parameters of Ranolazine|Peak Plasma Concentration (Cmax) with a 500 mg dose of ranolazine|At hours post-dose: 0, 2, 4, 8, 12, 15, 18, 20, 22, 23, 26, 30, 65||||mcg/mL||Standard Deviation|Mean
2677041|NCT01435122|Secondary|Occurrence of Possibly Related Adverse Events (AEs)|Grade 2 through 4 toxicities considered at least possibly related to treatment. Percentage of participants affected per category. Safety assessments will consist of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology and blood chemistry parameters and regular physical examinations. Adverse events will be evaluated continuously throughout the study. Safety and tolerability will be assessed according to the National Institute of Health/National Cancer Institute (NIH/NCI) Common Terminology Criteria for Adverse Events version 4 (CTCAE v4) available at: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm.|12 Months|All participants.|||percentage of participants|||Number
2677042|NCT01435122|Secondary|Time to Treatment Failure|Time to Treatment Failure: Time from administration of the initial dose of axitinib until study discontinuation for any reason (e.g., disease progression, toxicity, death, withdrawal of consent).|12 Months|All participants.|||months||95% Confidence Interval|Median
2677043|NCT01435122|Secondary|24 Month Overall Survival (OS) Rate|Overall survival by Kaplan Meier, determined from the time of drug administration to death from any cause. The effect of an intervention is assessed by measuring the number of subjects survived or saved after that intervention over a period of time. The time starting from a defined point to the occurrence of a given event, for example death is called as survival time and the analysis of group data as survival analysis.|24 months|All participants|||percentage of participants|||Number
2677044|NCT01435122|Secondary|Tumor Response Rate|Tumor response rate using RECIST. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|12 Months|All participants evaluable at time of analysis.|||Participants|||Count of Participants
2677045|NCT01435122|Primary|Median Progression Free Survival|Post follow-up progression free survival at time of analysis.|Up to 36 Months|All participants.|||months||95% Confidence Interval|Median
2677046|NCT01435122|Primary|Rate of Progression Free Survival (PFS)|Progression-free survival rate at 12 months. PFS: determined as the time from administration of the initial dose of axitinib until objective tumor progression using Response Evaluation Criteria In Solid Tumors (RECIST), or death. Progressive Disease (PD) Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. Stable Disease (SD): Neither sufficient shrinkage to qualify for Partial Response (PR) nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.|12 Months|All participants.|||percentage of participants|||Number
2677047|NCT01435031|Secondary|Number of Participants With Occurrence of Stent Fracture at Target Lesion|Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.|4 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days."|||Participants|||Count of Participants
2677048|NCT01435031|Secondary|Number of Participants With Occurrence of Stent Fracture at Target Lesion|Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.|3 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days."|||Participants|||Count of Participants
2677084|NCT01435031|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677049|NCT01435031|Secondary|Number of Participants With Occurrence of Stent Fracture at Target Lesion|Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.|2 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 720 days or ITT subjects with follow-up of at least 690 days."|||Participants|||Count of Participants
2677050|NCT01435031|Secondary|Number of Participants With Occurrence of Stent Fracture at Target Lesion|Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.|1 year|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 360 days or ITT subjects with follow-up of at least 330 days"|||Participants|||Count of Participants
2677051|NCT01435031|Secondary|Number of Participants With Stent Thrombosis|"Academic Research Consortium (ARC) criteria.~Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|4 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677052|NCT01435031|Secondary|Number of Participants With Stent Thrombosis|"Academic Research Consortium (ARC) criteria.~Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|3 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677053|NCT01435031|Secondary|Number of Participants With Stent Thrombosis|"Academic Research Consortium (ARC) criteria.~Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677054|NCT01435031|Secondary|Number of Participants With Stent Thrombosis|"Academic Research Consortium (ARC) criteria; definite and probable.~Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677055|NCT01435031|Secondary|Number of Participants With Stent Thrombosis|"Academic Research Consortium (ARC) criteria; definite and probable.~Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: Any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|Late (>30 days to 1 year)|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677056|NCT01435031|Secondary|Number of Participants With Stent Thrombosis|"Academic Research Consortium (ARC) criteria; definite and probable. Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: Any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|Subacute (>24 hours to 30 days)|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677069|NCT01435031|Secondary|Number of Participants With Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.~Target vessel failure will be reported when any of the following events occur:~Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is determined."|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677057|NCT01435031|Secondary|Number of Participants With Stent Thrombosis|"Academic Research Consortium (ARC) criteria; definite and probable~Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).~Probable stent thrombosis as defined by ARC criteria: Any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause."|Acute (0-24 hours)|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677058|NCT01435031|Secondary|Number of Participants With Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR|4 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days."|||Participants|||Count of Participants
2677059|NCT01435031|Secondary|Number of Participants With Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR|3 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days."|||Participants|||Count of Participants
2677060|NCT01435031|Secondary|Number of Participants With Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677061|NCT01435031|Secondary|Number of Participants With Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677062|NCT01435031|Secondary|Number of Participants With Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677063|NCT01435031|Secondary|Number of Participants With Target Lesion Failure (TLF)|Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677064|NCT01435031|Secondary|Number of Participants With Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.~Target vessel failure will be reported when ANY of the following events occur:~Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is determined."|4 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days."|||Participants|||Count of Participants
2677065|NCT01435031|Secondary|Number of Participants With Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.~Target vessel failure will be reported when ANY of the following events occur:~Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is determined."|3 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days."|||Participants|||Count of Participants
2677066|NCT01435031|Secondary|Number of Participants With Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.~Target vessel failure will be reported when ANY of the following events occur:~Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is determined."|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677067|NCT01435031|Secondary|Number of Participants With Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.~Target vessel failure will be reported when ANY of the following events occur:~Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is determined."|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677068|NCT01435031|Secondary|Number of Participants With Target Vessel Failure (TVF)|"Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.~Target vessel failure will be reported when ANY of the following events occur:~Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.~Cardiac death not clearly due to a non-target vessel endpoint.~Target vessel revascularization is determined."|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677082|NCT01435031|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|4 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677070|NCT01435031|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|"Repeat PCI or CABG of the target vessel.~Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study"|4 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677071|NCT01435031|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|"Repeat PCI or CABG of the target vessel.~Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study"|3 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677072|NCT01435031|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|"Repeat PCI or CABG of the target vessel.~Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study"|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677073|NCT01435031|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|"Repeat PCI or CABG of the target vessel.~Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study"|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677074|NCT01435031|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|"Repeat PCI or CABG of the target vessel.~Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study"|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677075|NCT01435031|Secondary|Number of Participants With All Target Vessel Revascularization (TVR)|Repeat PCI or CABG of the target vessel. Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677076|NCT01435031|Secondary|Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|4 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677077|NCT01435031|Secondary|Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|3 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677078|NCT01435031|Secondary|Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677079|NCT01435031|Secondary|Number of Participants With Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677080|NCT01435031|Secondary|Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677081|NCT01435031|Secondary|Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)|TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677085|NCT01435031|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677086|NCT01435031|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Repeat PCI or CABG to the target lesion/site.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677087|NCT01435031|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|Repeat percutaneous coronary intervention (PCI) or Coronary artery bypass graft (CABG) to the target lesion/site.|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677088|NCT01435031|Secondary|Number of Participants With Target Vessel-related MI|"TLF Component; per ARC~Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|4 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days."|||Participants|||Count of Participants
2677089|NCT01435031|Secondary|Number of Participants With Target Vessel-related MI|"TLF Component; per ARC~Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|3 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677090|NCT01435031|Secondary|Number of Participants With Target Vessel-related MI|"TLF Component; per ARC~Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677091|NCT01435031|Secondary|Number of Participants With Target Vessel-related MI|"TLF Component; per ARC~Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677092|NCT01435031|Secondary|Number of Participants With Target Vessel-related MI|"TLF Component; per ARC~Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677093|NCT01435031|Secondary|Number of Participants With Target Vessel-related MI|"TLF Component; per ARC~Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel."|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677094|NCT01435031|Secondary|Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component;~Myocardial Infarction (per ARC definition)~Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal~Non-Q-wave MI: All MIs not classified as Q-wave."|4 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days."|||Participants|||Count of Participants
2677095|NCT01435031|Secondary|Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component;~Myocardial Infarction (per ARC definition)~Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal~Non-Q-wave MI: All MIs not classified as Q-wave."|3 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677096|NCT01435031|Secondary|Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component;~Myocardial Infarction (per ARC definition)~Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal~Non-Q-wave MI: All MIs not classified as Q-wave."|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677097|NCT01435031|Secondary|Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component;~Myocardial Infarction (per ARC definition)~Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal~Non-Q-wave MI: All MIs not classified as Q-wave."|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677098|NCT01435031|Secondary|Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component;~Myocardial Infarction (per ARC definition)~Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal~Non-Q-wave MI: All MIs not classified as Q-wave."|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677099|NCT01435031|Secondary|Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)|"MACE Component;~Myocardial Infarction (per ARC definition)~Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal~Non-Q-wave MI: All MIs not classified as Q-wave."|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677100|NCT01435031|Secondary|Number of Participants Experiencing Cardiac Death|"TLF component.~Cardiac death was defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|4 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days."|||Participants|||Count of Participants
2677101|NCT01435031|Secondary|Number of Participants Experiencing Cardiac Death|"TLF component.~Cardiac death was defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|3 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677102|NCT01435031|Secondary|Number of Participants Experiencing Cardiac Death|"TLF component.~Cardiac death was defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677103|NCT01435031|Secondary|Number of Participants Experiencing Cardiac Death|"TLF component.~Cardiac death was defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677104|NCT01435031|Secondary|Number of Participants Experiencing Cardiac Death|"TLF component.~Cardiac death was defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677105|NCT01435031|Secondary|Number of Participants Experiencing Cardiac Death|"TLF component.~Cardiac death was defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded"|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677106|NCT01435031|Secondary|Number of Participants Experiencing Death|"MACE Component; per protocol.~Death is divided into 2 categories:~Cardiac death is defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|4 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days."|||Participants|||Count of Participants
2677107|NCT01435031|Secondary|Number of Participants Experiencing Death|"MACE Component; per protocol.~Death is divided into 2 categories:~Cardiac death is defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|3 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days."|||Participants|||Count of Participants
2677108|NCT01435031|Secondary|Number of Participants Experiencing Death|"MACE Component; per protocol.~Death is divided into 2 categories:~Cardiac death is defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|2 years|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677124|NCT01435031|Secondary|Percentage of Participants With Procedural Success With Kissing Wire Technique|Defined as device success and absence of in-hospital MACE with antegrade crossing technique|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set.The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.|||percentage of participants|||Number
2677109|NCT01435031|Secondary|Number of Participants Experiencing Death|"MACE Component; per protocol.~Death is divided into 2 categories:~Cardiac death is defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677110|NCT01435031|Secondary|Number of Participants Experiencing Death|"MACE Component; per protocol.~Death is divided into 2 categories:~Cardiac death is defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677111|NCT01435031|Secondary|Number of Participants Experiencing Death|"MACE Component; per protocol.~Death is divided into 2 categories:~Cardiac death is defined as death due to any of the following:~Acute MI~Cardiac perforation/pericardial tamponade~Arrhythmia or conduction abnormality~Stroke within 30 days of the procedure or stroke suspected of being related to the procedure~Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery~Any death in which a cardiac cause cannot be excluded.~Non-cardiac death is defined as a death not due to cardiac causes (as defined above)."|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677112|NCT01435031|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|4 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days."|||Participants|||Count of Participants
2677113|NCT01435031|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|3 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days."|||Participants|||Count of Participants
2677114|NCT01435031|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|2 years|"ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.~The overall number of participants analysed include ITT subjects who experienced the specific event within 720 days or ITT subjects with follow-up of at least 690 days."|||Participants|||Count of Participants
2677115|NCT01435031|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|1 year|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677116|NCT01435031|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|6 months|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677117|NCT01435031|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE)|Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.|30 days|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2677118|NCT01435031|Secondary|Percentage of Participants With Clinically Significant Perforation|Any perforation resulting in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft or comparable therapy|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT Set|||percentage of participants||95% Confidence Interval|Number
2677119|NCT01435031|Secondary|Resource Utilization: Contrast Volume||Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set.|||mL||Standard Deviation|Mean
2677120|NCT01435031|Secondary|Resource Utilization: Fluoroscopic Time||Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set.|||Minutes||Standard Deviation|Mean
2677121|NCT01435031|Secondary|Resource Utilization: Procedural Time||Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set.|||Minutes||Standard Deviation|Mean
2677122|NCT01435031|Secondary|Percentage of Participants With Procedural Success With Multiple Crossing Techniques|Defined as device success and absence of in-hospital MACE with antegrade crossing technique|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.|||percentage of participants|||Number
2677123|NCT01435031|Secondary|Percentage of Participants With Procedural Success With Sub Intimal Technique|Defined as device success and absence of in-hospital MACE with antegrade crossing technique.|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.|||percentage of participants|||Number
2677125|NCT01435031|Secondary|Percentage of Participants With Procedural Success With Reverse CART|Defined as device success and absence of in-hospital MACE with antegrade crossing technique|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.|||percentage of participants|||Number
2677126|NCT01435031|Secondary|Percentage of Participants With Procedural Success With Controlled Antegrade-Retrograde Technique (CART)|Defined as device success and absence of in-hospital MACE with antegrade crossing technique|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.|||percentage of participants|||Number
2677127|NCT01435031|Secondary|Percentage of Participants With Procedural Success With Primary Retrograde Wire Crossing|Defined as device success and absence of in-hospital MACE with antegrade crossing technique|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.|||percentage of participants|||Number
2677128|NCT01435031|Secondary|Percentage of Participants With Procedural Success With Knuckle Wire|Defined as device success and absence of in-hospital MACE with antegrade crossing technique|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.|||percentage of participants|||Number
2677129|NCT01435031|Secondary|Percentage of Participants With Procedural Success With Subintimal Tracking and Re-entry (STAR) Technique|Defined as device success and absence of in-hospital MACE with antegrade crossing technique|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.|||percentage of participants|||Number
2677130|NCT01435031|Secondary|Percentage of Participants With Procedural Success With Antegrade Crossing|Defined as device success and absence of in-hospital MACE with antegrade crossing technique.|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.|||percentage of participants|||Number
2677131|NCT01435031|Secondary|Percentage of Participants With Procedure Success|"Device success and absence of in-hospital MACE.~Per-protocol MI definition: Myocardial infarctions per protocol definition were categorized as Q-wave (development of new, pathological Q waves on the ECG) or non-Q-wave (elevation of CK levels to greater than two times the upper limit of normal and elevated CK-MB in the absence of new pathological Q waves).~Per ARC MI definition: Myocardial infarctions per ARC definition were also categorized as Q-wave (development of new pathological Q waves in 2 or more contiguous leads (according to the Minnesota code) with or without post-procedure CK or CK-MB levels elevated above normal) or non-Q-wave (all MIs not classified as Q-wave). ARC defined MIs were further classified as Periprocedural PCI, Periprocedural CABG, Spontaneous, Sudden Death, and Reinfarction based on biomarker and additional criteria and as ST Elevation MI (STEMI) or Non-ST Elevation MI (NSTEMI) based on ST segment."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||percentage of participants||95% Confidence Interval|Number
2677132|NCT01435031|Secondary|Percentage of Participants With Device Success|Achievement of <50% diameter stenosis within the target lesion segment using assigned study device|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||percentage of participants||95% Confidence Interval|Number
2677133|NCT01435031|Secondary|Percentage of Participants With Change in TIMI Flow Grade: Post-procedure|"Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.~TIMI Classification:~TIMI 0 No perfusion.~TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run.~TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel.~TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||percentage of participants||95% Confidence Interval|Number
2677134|NCT01435031|Secondary|Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure|"Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.~TIMI Classification:~TIMI 0 No perfusion.~TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run.~TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel.~TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set.The number of participants analyzed include subjects who had available follow up data at that time frame.|||percentage of participants||95% Confidence Interval|Number
2677135|NCT01435031|Secondary|Minimum Lumen Diameter (MLD): Post-procedure|"Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.~MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Laboratory."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||mm||Standard Deviation|Mean
2677136|NCT01435031|Secondary|Minimum Lumen Diameter (MLD): Pre-procedure|"Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.~MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during Quantitative coronary angiography (QCA) by the Angiographic Core Laboratory."|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.|||mm||Standard Deviation|Mean
2677137|NCT01435031|Primary|Percentage of Participants With Angioplasty Predilatation-related: Successful Predilatation of the CTO|"Successful delivery of the MINI-TREK Coronary Dilatation Catheter to and across the target lesion and;~Successful inflation and deflation of the MINI-TREK Coronary Dilatation Catheter and;~Absence of clinically significant vessel perforation, flow-limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) from baseline or clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with MINI-TREK and;~Achievement of final TIMI flow 3 for the target lesion at the conclusion of the index procedure"|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|Angiographically Evaluable Subjects|||percentage of participants||95% Confidence Interval|Number
2677138|NCT01435031|Primary|Percentage of Participants With Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI)|"Successful recanalization of the CTO defined as:~Confirmation of placement of the guide wire in the distal true lumen (component 1)~Absence of in-hospital MACE, based on protocol MI (component 2)"|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|All the subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and in whom an attempt was made to cross the target lesion with the HT Progress or the HT Pilot guide wires, are included in the ITT population for the guide wire-related analysis.|||percentage of participants||95% Confidence Interval|Number
2677139|NCT01435031|Primary|Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI)|"Successful recanalization of the CTO defined as:~Confirmation of placement of the guide wire in the distal true lumen (component 1)~Absence of in-hospital MACE, based on ARC MI (component 2)"|Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes|All the subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and in whom an attempt was made to cross the target lesion with the HT Progress or the HT Pilot guide wires, are included in the ITT population for the guide wire-related analysis.|||percentage of participants||95% Confidence Interval|Number
2677140|NCT01435031|Primary|Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per Protocol Set)|The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.|1 year|Per-protocol (PP) definition: The per-protocol population is defined as all ITT subjects in whom at least 1 study stent was implanted, met procedure success, had available follow up data (i.e. a MACE event within 360 days or follow up of at least 330 days), and did not have major protocol deviations due to inappropriate enrollment.|||Participants|||Count of Participants
2677141|NCT01435031|Primary|Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set)|The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.|1 year|Intention-to-treat (ITT) definition: ITT subjects include all subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and whose target lesion was successfully crossed and predilated.|||Participants|||Count of Participants
2677142|NCT01435018|Secondary|Cellular and Humoral Markers of Immune Function and Activation|This outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|Baseline, weeks 60, 120, 180, 240||2021-03-31|03/2021||||
2677143|NCT01435018|Secondary|RNA Levels for KSHV Genes|This outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|Baseline, weeks 60, 120, 180, 240||2021-03-31|03/2021||||
2677144|NCT01435018|Secondary|Peripheral Blood Mononuclear Cell (PBMC) KSHV|This outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|Baseline, weeks 60, 120, 180, 240||2021-03-31|03/2021||||
2677145|NCT01435018|Secondary|Plasma KS-associated Herpesvirus (KSHV)|This outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|Baseline, weeks 60, 120, 180, 240||2021-03-31|03/2021||||
2677146|NCT01435018|Secondary|Immunohistochemical Evaluations of Viral and Cellular Gene Expression.|This outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available|Baseline, 24-48 hours after 2nd chemo-therapy cycle begins||2021-03-31|03/2021||||
2677147|NCT01435018|Secondary|Quality of Life Measures|This outcome was not included in the primary analyses and will be defined in more detail in a separate analysis plan. Results will be reported to ct.gov when available.|Baseline, weeks 60, 120, 180, 240||2021-03-31|03/2021||||
2677148|NCT01435018|Secondary|Salivary KSHV|Funding for oral KS objectives including data and sample collection was withdrawn during the study conduct.|Baseline, weeks 60, 120, 180, 240|The corresponding outcome measure was withdrawn.||||||
2677149|NCT01435018|Secondary|Presence of Oral KS|Funding for oral KS objectives including data and sample collection was withdrawn during the study conduct.|From study entry to week 240|The corresponding outcome measure was withdrawn.||||||
2677150|NCT01435018|Secondary|Self-reported Adherence to ART Therapy|ART adherence is based on participant's recall of the number of missed ART doses for the past month. Perfect adherence is defined as having zero missed ART doses.|At Weeks 6, 12, 18, 30 and 48|All eligible participants who initiated study chemotherapy with available data as of March 2018.|||Participants|||Count of Participants
2677151|NCT01435018|Secondary|Changes in CD4+ Lymphocyte Cell Count for BV+ART vs. PTX+ART|Baseline CD4 lymphocyte cell count is the mean of screening and Step 1 entry CD4 values. Absolute change in CD4+ lymphocyte cell count was calculated as value at a given visit minus the baseline CD4 lymphocyte cell count.|Baseline, weeks 12, 24, 48|All eligible participants who initiated study chemotherapy with available data as of March 2018.|||cells/mm^3||Inter-Quartile Range|Median
2677152|NCT01435018|Secondary|Changes in CD4+ Lymphocyte Cell Count for ET+ART vs. PTX+ART|Baseline CD4 lymphocyte cell count is the mean of screening and Step 1 entry CD4 values. Absolute change in CD4+ lymphocyte cell count was calculated as value at a given visit minus the baseline CD4 lymphocyte cell count.|Baseline, weeks 12, 24, 48|All eligible participants who initiated study chemotherapy with available data as of March 2016.|||cells/mm^3||Inter-Quartile Range|Median
2677153|NCT01435018|Secondary|Number of Participants With Treatment-related Toxicities and Adverse Events (AEs)|Adverse events classified by the site personnel as possibly, probably or definitely related to ART or chemotherapy.|From study entry to week 240|All eligible participants who initiated study chemotherapy with available data as of March 2018.|||Participants|||Count of Participants
2677154|NCT01435018|Secondary|Number of Participants With Peripheral Neuropathy (PN)|Presence of PN is defined as having all of the following results: presence of symptomatic PN, abnormal perception of vibrations, and absent or hypoactive deep tendon reflexes.|Screening, Weeks 3, 6, 9, 12, 15, 18, 21. Assessment of PN for ET+ART was only done at screening, weeks 9 and 21.|All eligible participants who initiated study chemotherapy with available data as of March 2018.|||Participants|||Count of Participants
2677155|NCT01435018|Secondary|Number of Participants With Symptomatic Peripheral Neuropathy (SPN)|"SPN consists of three assessments: (1) pain, aching or burning in feet, legs, (2) pins and needles in feet, legs, and (3) numbness (lack of feeling) in feet, legs. SPN is graded on a severity scale from 0 (not present), 1 (mild) to 10 (severe). Presence of SPN is defined as having grade ≥1 in at least one of the three assessments."|Screening, Weeks 3, 6, 9, 12, 15, 18, 21. Assessment of SPN for ET+ART was only done at screening, weeks 9 and 21.|All eligible participants who initiated study chemotherapy with available data as of March 2018.|||Participants|||Count of Participants
2677156|NCT01435018|Secondary|Duration of Objective Response for BV+ART vs. PTX+ART|Duration of objective response is the number of weeks from first complete or partial response to the earliest among progression, death or off study week. The 25th percentile duration is presented.|From study entry up to week 144|All eligible participants who initiated study chemotherapy with complete of partial KS response in Step 1 as of March 2018.|||weeks||95% Confidence Interval|Number
2677157|NCT01435018|Secondary|Duration of Objective Response for ET+ART vs. PTX+ART|Duration of objective response is the number of weeks from first complete or partial response to the earliest among progression, death or off study week. The 25th percentile duration is presented.|From study entry up to week 144|All eligible participants who initiated study chemotherapy with complete of partial KS response in Step 1 as of March 2016.|||weeks||95% Confidence Interval|Number
2677158|NCT01435018|Secondary|Number of Participants With Objective Response for BV+ART vs. PTX+ART|The number of participants with objective response (complete response or partial response) as best overall KS response in Step 1. Overall KS response status (complete response, partial response, stable, disease progression) was based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|From study entry up to week 144|All eligible participants who initiated study chemotherapy with available data as of March 2018.|||Participants|||Count of Participants
2677159|NCT01435018|Secondary|Number of Participants With Objective Response for ET+ART vs. PTX+ART|The number of participants with objective response (complete response or partial response) as best overall KS response in Step 1. Overall KS response status (complete response, partial response, stable, disease progression) was based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|From study entry up to week 144|All eligible participants who initiated study chemotherapy with available data as of March 2016.|||Participants|||Count of Participants
2677160|NCT01435018|Secondary|Time to IERC-confirmed KS Progression or Death for BV+ART vs. PTX+ART|Time to IERC-confirmed KS progression or death was computed as the number of weeks between study entry and the earlier between date of IERC-confirmed KS progression or date of death. For participants who did not have the event, event time was censored at the week of last contact with the participant or at the participant's off study week, whichever is later.The 25-th percentile and hazard ratio are presented.|From study entry to week 240|All eligible participants who initiated study chemotherapy with available data as of March 2018.|||weeks||95% Confidence Interval|Number
2677161|NCT01435018|Secondary|Time to IERC-confirmed KS Progression or Death for ET+ART vs. PTX+ART|Time to IERC-confirmed KS progression or death was computed as the number of weeks between study entry and the earlier between date of IERC-confirmed KS progression or date of death. For participants who did not have the event, event time was censored at the week of last contact with the participant or the participant's off study week, whichever is later. The 25-th percentile and hazard ratio are presented.|From study entry to week 240|All eligible participants who initiated study chemotherapy with available data as of March 2016.|||weeks||95% Confidence Interval|Number
2677162|NCT01435018|Secondary|Cumulative Rate of Death for BV+ART vs PTX+ART|The Kaplan-Meier estimate of the cumulative rate of death. Time to death was computed as the number of weeks between study entry and date of death. For participants who did not have the event, time to death was censored at the week of last contact with the participant or at the participant's off study week, whichever is later.|From study entry to week 240|All eligible participants who initiated study chemotherapy with available data as of March 2018.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677190|NCT01434810|Secondary|Number of Participants Requiring Exchange Blood Transfusion|Exchange blood transfusion required to lower the bilirubin level. Serum bilirubin will be measured twice daily during filtered sunlight or conventional phototherapy exposure, for an expected average of four days, and a maximum of ten days.|Four to ten days|The need for exchange blood transfusion was assessed on all 447 enrolled participants.|||Participants|||Count of Participants
2677163|NCT01435018|Secondary|Cumulative Rate of Death for ET+ART vs. PTX+ART|The Kaplan-Meier estimate of the cumulative rate of death. Time to death was computed as the number of weeks between study entry and date of death. For participants who did not have the event, time to death was censored at the week of last contact with the participant or at the participant's off study week, whichever is later.|From study entry to week 240|All eligible participants who initiated study chemotherapy with available data as of March 2016.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677164|NCT01435018|Secondary|Cumulative Rate of Change in KS Treatment by Week 48 for BV+ART vs. PTX+ART|The Kaplan-Meier estimate of the cumulative rate of change in KS treatment by week 48. Change in KS treatment was defined as stopping Step 1 randomized chemotherapy and initiating a different chemotherapy.|From study entry to week 48|All eligible participants who initiated study chemotherapy with available data as of March 2018.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677165|NCT01435018|Secondary|Cumulative Rate of Change in KS Treatment by Week 48 for ET+ART vs. PTX+ART|The Kaplan-Meier estimate of the cumulative rate of change in KS treatment by week 48. Change in KS treatment was defined as stopping Step 1 randomized chemotherapy and initiating a different chemotherapy.|From study entry to week 48|All eligible participants who initiated study chemotherapy with available data as of March 2016.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677166|NCT01435018|Secondary|Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for BV+ART vs. PTX+ART|The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.|From study entry to week 48|All eligible participants who initiated study chemotherapy with available data as of March 2018.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677167|NCT01435018|Secondary|Cumulative Rate of KS Progression, Death, AIDS Defining Event, Virologic Failure, or KS-IRIS by Week 48 for ET+ART vs. PTX+ART|The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, virologic failure, or KS-IRIS.|From study entry to week 48|All eligible participants who initiated study chemotherapy with available data as of March 2016.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677168|NCT01435018|Secondary|Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for BV+ART vs. PTX+ART|The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, or virologic failure by week 48|From study entry to week 48|All eligible participants who initiated study chemotherapy with available data as of March 2018.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677169|NCT01435018|Secondary|Cumulative Rate of KS Progression, Death, AIDS Defining Event, or Virologic Failure by Week 48 for ET+ART vs. PTX+ART|The Kaplan-Meier estimate of the cumulative rate of KS progression, death, AIDS defining event, or virologic failure by week 48|From study entry to week 48|All eligible participants who initiated study chemotherapy with available data as of March 2016.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677170|NCT01435018|Secondary|Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for BV+ART vs. PTX+ART|The Kaplan-Meier estimate of the cumulative rate of KS progression, death, or AIDS defining event by week 48|From study entry to week 48|All eligible participants who initiated study chemotherapy with available data as of March 2018.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677171|NCT01435018|Secondary|Cumulative Rate of KS Progression, Death, or AIDS Defining Event by Week 48 for ET+ART vs. PTX+ART|The Kaplan-Meier estimate of the cumulative rate of KS progression, death, or AIDS defining event by week 48|From study entry to week 48|All eligible participants who initiated study chemotherapy with available data as of March 2016.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677172|NCT01435018|Secondary|Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for BV+ART vs. PTX+ART|KS-IRIS is defined as any IERC-confirmed KS-progression that occurs within 12 weeks of ART-initiation that is associated with an increase in CD4 cell count of at least 50 cells/mm3 above the study entry value and/or a decrease in the HIV-1 RNA level by at least 0.5 log below the study entry value prior to or at the time of documented KS progression.|From study entry to week 12|All eligible participants who initiated study chemotherapy with available data as of March 2018.|||Participants|||Count of Participants
2677173|NCT01435018|Secondary|Number of Participants With Kaposi's Sarcoma-Immune Reconstitution Inflammatory Syndrome (KS-IRIS) for ET+ART vs. PTX+ART|KS-IRIS is defined as any IERC-confirmed KS-progression that occurs within 12 weeks of ART-initiation that is associated with an increase in CD4 cell count of at least 50 cells/mm³ above the study entry value and/or a decrease in the HIV-1 RNA level by at least 0.5 log below the study entry value prior to or at the time of documented KS progression.|From study entry to week 12|All eligible participants who initiated study chemotherapy with available data as of March 2016.|||Participants|||Count of Participants
2677174|NCT01435018|Secondary|Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for BV+ART vs. PTX+ART|Virologic failure is defined as two successive measurements of plasma HIV-1 RNA ≥1000 copies/mL at week 12 to week 24 or RNA ≥400 copies/mL at week 24 or later.|From study entry to week 48|All eligible participants who initiated study chemotherapy with available data as of March 2018.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677175|NCT01435018|Secondary|Cumulative Rate of HIV-1 RNA Virologic Failure by Week 48 for ET+ART vs. PTX+ART|Virologic failure is defined as two successive measurements of plasma HIV-1 RNA ≥1000 copies/mL at week 12 to week 24 or RNA ≥400 copies/mL at week 24 or later.|From study entry to week 48|All eligible participants who initiated study chemotherapy with available data as of March 2016.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677176|NCT01435018|Secondary|Cumulative Rate of AIDS-defining Event by Week 48 for BV+ART vs. PTX+ART|The Kaplan-Meier estimate of the cumulative rate of AIDS-defining events by week 48. AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Time to event was computed as the number of weeks from study entry to the first AIDS-defining event. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48.|From study entry to week 48|All eligible participants who initiated study chemotherapy with available data as of March 2018.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677177|NCT01435018|Secondary|Cumulative Rate of AIDS-defining Event by Week 48 for ET+ART vs. PTX+ART|The Kaplan-Meier estimate of the cumulative rate of AIDS-defining events by week 48. AIDS-defining events refer to non-KS AIDS-defining diagnosis (WHO Stage 4 (2007), plus microsporidiosis, cyclospora gastroenteritis, Chagas disease and visceral leishmaniasis). Time to event was computed as the number of weeks from study entry to the first AIDS-defining event. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48.|From study entry to week 48|All eligible participants who initiated study chemotherapy with available data as of March 2016.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677178|NCT01435018|Secondary|Cumulative Rate of IERC-confirmed KS Progression by Week 48 for BV+ART vs. PTX+ART|The Kaplan-Meier estimate of the cumulative rate of IERC-confirmed KS progression by week 48. IERC-confirmed KS progression was defined as KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|From study entry to week 48|All eligible participants who initiated study chemotherapy with available data as of March 2018.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677179|NCT01435018|Secondary|Cumulative Rate of IERC-confirmed KS Progression by Week 48 for ET+ART vs. PTX+ART|The Kaplan-Meier estimate of the cumulative rate of IERC-confirmed KS progression by week 48. IERC-confirmed KS progression was defined as KS disease progression confirmed by the IERC based on comparing follow-up KS response to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|From study entry to week 48|All eligible participants who initiated study chemotherapy with available data as of March 2016.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677180|NCT01435018|Secondary|Cumulative Rate of Death by Week 48 for BV+ART vs. PTX+ART|The Kaplan-Meier estimate of the cumulative rate of death by week 48. Time to death was computed as the number of weeks from study entry to the death date. For participants who did have the event, time to death was censored at the week of last contact with the participant. Time to death above 48 were censored at week 48.|From study entry to week 48|All eligible participants who initiated study chemotherapy with available data as of March 2018.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677181|NCT01435018|Secondary|Cumulative Rate of Death by Week 48 for ET+ART vs. PTX+ART|The Kaplan-Meier estimate of the cumulative rate of death by week 48. Time to death was computed as the number of weeks from study entry to date of death. For participants who did have the event, time to death was censored at the week of last contact with the participant. Time to death above 48 were censored at week 48.|From study entry to week 48|All eligible participants who initiated study chemotherapy with available data as of March 2016.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677182|NCT01435018|Primary|Cumulative Rate of Progression-Free Survival by Week 48 for BV+ART vs. PTX+ART|Progression-free survival (PFS) by week 48 is defined as a lack of the following events: (a) Independent Endpoint Review Committee (IERC)-confirmed KS progression, (b) death, (c) entry into an additional step, or (d) loss to follow-up, prior to week 48. PFS rate was estimated by the Kaplan-Meier survival probability at week 48. Time to event was computed as the number of weeks from study entry to the first among these events. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. Overall KS outcome status (complete response, partial response, stable, disease progression) was based on comparing follow-up to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|From study entry to week 48|All eligible participants who initiated study chemotherapy with available data as of March 2018.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677183|NCT01435018|Primary|Cumulative Rate of Progression-Free Survival by Week 48 for ET+ART vs. PTX+ART|Progression-free survival (PFS) by week 48 is defined as a lack of the following events: (a) Independent Endpoint Review Committee (IERC)-confirmed KS progression, (b) death, (c) entry into an additional step, or (d) loss to follow-up, prior to week 48. PFS rate was estimated by the Kaplan-Meier survival probability at week 48. Time to event was computed as the number of weeks from study entry to the first among these events. For participants who did not have any of the events, event time was censored at the week of last contact with the participant. Follow-up time beyond 48 was censored at week 48. Overall KS outcome status (complete response, partial response, stable, disease progression) was based on comparing follow-up to study entry or best KS response with respect to clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|From study entry to week 48|All eligible participants who initiated study chemotherapy with available data as of March 2016.|||Cumulative events per 100 persons||95% Confidence Interval|Number
2677184|NCT01434823|Secondary|Daytime Intensivist Daily Sleep Duration|This will be the primary outcome of the Intensivist Sleep and Work sub-study.|Daily||||hours||Standard Deviation|Mean
2677185|NCT01434823|Secondary|Discharge Home From Hospital|Patients who were discharged from the hospital to their homes|Assessed up to 12 months||||participants|||Number
2677186|NCT01434823|Secondary|Re-admission to the MICU Within 48 Hours|The investigators will measure, in hours, the time spent from discharge from the MICU until a patient is re-admitted to the MICU during the same hospital stay.|From time of discharge from MICU, to re-admission to the MICU - assessed up to 12 months||||participants|||Number
2677187|NCT01434823|Secondary|In-hospital Mortality|Mortality will be assessed during each patient's stay in the hospital.|From time of admission to MICU to hospital discharge - assessed up to 12 months||||participants|||Number
2677188|NCT01434823|Secondary|MICU Mortality|Mortality will be assessed during each patient's stay in the MICU from admission to discharge|From time of admission to MICU until discharge from MICU - assessed up to 12 months||||participants|||Number
2677189|NCT01434823|Primary|MICU Length of Stay|Time from ICU admission to discharge|From time of admission in the MICU until time of discharge from the MICU - assessed up to 12 months||||hours||Inter-Quartile Range|Median
2677191|NCT01434810|Primary|Efficacy of Phototherapy|For a given evaluable treatment day, the phototherapy treatment was deemed effective if that infant on that day had a decrease in serum bilirubin level or (if <72hrs old) an rate of increase of less than 0.2 mg/dL/h. Therefore efficacy is reported as a percentage of the evaluable treatment days (i.e. number of effective evaluable treatment days divided by total number of evaluable treatment days).|Four to ten days|The efficacy analysis was carried out on the 561 treatment days which were evaluable (see flow chart).|||treatment days|treatment days||Count of Units
2677192|NCT01434810|Primary|Safety of Phototherapy|For a given treatment day, the phototherapy treatment was deemed safe if that infant on that day did not have to be withdrawn from treatment due to hypo- or hyperthermia, sunburn or dehydration. Therefore safety is reported as a percentage of the total treatment days (i.e. number of safe treatment days divided by total number of treatment days).|Four to ten days|Safety was assessed for all 593 days on which treatment was received, in all 433 participants who were treated.|||treatment days|treatment days||Count of Units
2677193|NCT01434745|Secondary|FA|Fractional anisotropy as measured by brain diffusion tensor imaging (DTI)|end of treatment, an average of 1 per year|Analyses were not completed and will never be completed due to insufficient funding||||||
2677194|NCT01434745|Secondary|MRS Lipids|Brain magnetic resonance spectroscopy|end of treatment, an average of 1 per year|Analyses were not completed and will never be completed due to insufficient funding||||||
2677195|NCT01434745|Secondary|MVA|urinary mevalonate excretion|through study completion, an average of 2 per year|Analyses were not completed and will never be completed due to insufficient funding||||||
2677196|NCT01434745|Secondary|ADC|Apparent diffusion coefficient measured by brain diffusion tensor imaging (DTI)|end of treatment, an average of 1 per year|Analyses were not completed and will never be completed due to insufficient funding||||||
2677197|NCT01434745|Secondary|Plasma Marker of Sterol Metabolism|Blood cholesterol to 7-dehydrocholesterol ratio|through study completion, an average of 2 per year|Analyses were not completed and will never be completed due to insufficient funding||||||
2677198|NCT01434745|Secondary|Whole Body Cholesterol Pool Size, Synthesis & Absorption Using Stable Isotope Testing|administration of cholesterol and water labeled with stable isotope followed by measurement overtime in blood concentrations|end of treatment, an average of 1 per year|Analyses were not completed and will never be completed due to insufficient funding||||||
2677199|NCT01434745|Primary|Development Quotient (DQ)|neurocognitive assessment measured with Mullen Scales of Learning|through study completion, an average of 2 per year|No funding||||||
2677200|NCT01434693|Primary|Incidence of Adverse Events|Comparison of safety and tolerability was performed across the dose levels by evaluating the post-dose tolerability of TSO in patients with Crohn's Disease via incidence of adverse events (i.e. # events) with a specific focus on reported gastrointestinal signs and symptoms|6 mo|All patients who were randomized were treated according to the protocol and therefore were all included in the Safety Population.|||events|||Number
2677201|NCT01434680|Secondary|Number Of Subjects Reporting Solicited Local And Systemic Adverse Events|"Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following a single injection with either MenC-CRM LIQ or MenC-CRM ROS or MenC-CRM EMV.~Safety was also assessed in subjects who mistakenly received MenC-CRM EMV instead of MenC-CRM ROS."|From day 1 through day 7|Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data.|||Number of subjects|||Number
2677202|NCT01434680|Secondary|Geometric Mean hSBA Titers Against N Meningitidis Serogroup C 28 Days After Vaccination|Immunogenicity was measured by hSBA GMTs against N meningitidis type C, approximately 28 days (at day 29) after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM ROS.|1 month postvaccination (day 29)|Analysis was done on the per protocol (PP) set.|||Titers||95% Confidence Interval|Geometric Mean
2677203|NCT01434680|Primary|Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup C 28 Days After Vaccination|Immunogenicity was measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs)against N meningitidis type C, at day 29 after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM EMV and MenC-CRM ROS to MenC-CRM EMV.|1 month postvaccination (day 29)|Analysis was done on the per protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.|||Titers||95% Confidence Interval|Geometric Mean
2677204|NCT01434667|Secondary|Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate.|"Yes/no response to the question, Since receiving your Alzheimer's disease risk estimate, have you joined any other Alzheimer's disease-related research studies?"|6 weeks and 6 months post-disclosure|Participants who provided data on these survey items|||Participants|||Count of Participants
2677205|NCT01434667|Secondary|Insurance and Advance Planning Changes|A series of yes/no questions that ask whether the risk assessment motivated changes to insurance or advance planning.|6 months post-disclosure|Participants who provided data on the 6-month follow-up survey about these outcomes|||Participants|||Count of Participants
2677206|NCT01434667|Secondary|Health Behavior and Insurance Changes|AD prevention behaviors enacted within the prior two weeks.|Baseline, 6 weeks post-disclosure, and 6 months post-disclosure|Participants who provided data on health behaviors at each time point.|||Participants|||Count of Participants
2677207|NCT01434667|Secondary|User Ratings of Risk Assessment Experience|"Subjective ratings of the impact of risk assessment. Participants provided ratings on a 1-5 scale, with 1 being very negative and 5 being very positive"|6 Weeks and 6 Months Post-disclosure|Participants who completed these items in the post-disclosure surveys.|||score on a scale||Standard Deviation|Mean
2677208|NCT01434667|Secondary|Participant Satisfaction|How well participants' expectations about information, explanations, reassurance, advice, and help in decision making were met. Participants rated satisfaction for each dimension on a 1-7 scale, with higher scores indicating that expectations were met better.|6 Weeks and 6 Months Post-disclosure|Participants who provided responses on each expectation item|||score on a scale||Standard Deviation|Mean
2677209|NCT01434667|Secondary|Recall and Comprehension of Risk Information|"Several measures to assess participant recall and comprehension of personalized risk information for AD. The sum number correct of the two items that were presented to both randomization arms (What form of APOE increases risk for Alzheimer's disease?, and What percentage were you given as your 3-year risk of developing Alzheimer's disease?) are summarized here."|6 Weeks and 6 Months Post-disclosure|Participants who provided data on each scale.|||score on a scale||Standard Deviation|Mean
2677210|NCT01434667|Secondary|Psychological Impact of Test Disclosure (IGT-AD)|A 15-item scale measuring distress specific to the test results received. Scores range from 0-75, with higher scores indicating greater test-related distress. Higher scores indicate greater distress about the risk assessment.|6 Weeks and 6 Months Post-disclosure|Participants who completed the full 15-item scale|||score on a scale||Standard Deviation|Mean
2677211|NCT01434667|Secondary|Impact of Event Scale (IES)|The Impact of Event assesses intrusive thoughts and avoidance related to a specific stressful life event. It is a 15-item self-report measure with scores that range from 0 to 75, with greater scores indicating greater distress about the event.|1-3 Days, 6 Weeks and 6 Months Post-disclosure|Participants who completed the full 15-item scale.|||score on a scale||Standard Deviation|Mean
2677212|NCT01434667|Primary|Mini State Trait Anxiety Inventory|Validated introspective psychological inventory consisting of 6 self-report items pertaining to anxiety affect. Responses are transformed into scores that range from 20 to 80, with higher scores indicating greater anxiety.|Baseline, 6 weeks post-disclosure, and 6 months post-disclosure|Participants who completed the full 6-item scale|||score on a scale||Standard Deviation|Mean
2677213|NCT01434667|Primary|Geriatric Depression Scale|A 15-item self-report assessment used to identify depression in the elderly. GDS scores ranged from 0-15. Higher scores indicated greater depression.|Baseline, 6 weeks post-disclosure, and 6 months post-disclosure|Participants who completed the full 15-item scale.|||score on a scale||Standard Deviation|Mean
2677214|NCT01434654|Secondary|Cerebrospinal Fluid|To measure plateaux CSF ARV concentrations. This will identify the proportion of patients achieving levels of specific ARVs capable of inhibiting 95% of in vitro viral replication (IC95).|Baseline to 12 Months|Data presented for n=5 participants with detectable CSF ARV concentrations who had lumbar puncture at Baseline and 12 months. The pre-specified analysis was not conducted as nevirapine, raltegravir, and darunavir were the only ARVs detected in CSF, and of these, only nevirapine was detected above the minimum threshold (set at >50 ug/L).|||ug/L||Standard Error|Mean
2677215|NCT01434654|Secondary|Change in MRS Cerebral Metabolite Ratios in Frontal White Matter|Change in major cerebral metabolites in the frontal white matter, as measured by 1H-Magnetic Resonance Spectroscopy (MRS), between baseline and 12-months. Spectra were acquired on a Phillips Achieva 3T MRI scanner using point-resolved spectroscopy (PRESS) sequence with short TE. jMRUI/AMARES algorithm was used to process spectra. Metabolite ratios were calculated for the following metabolites: N-acetyl aspartate (NAA), choline (Cho), creatine (Cr), myo-inositol (mIo), glutamate/glutamine complex (Glx), in relation to internal H20 as standard.|Baseline and 12 months|n=1 participant in high CNS penetrance arm did not return for 12-months follow-up visit. Their baseline data were therefore excluded from analysis.|||Ratio||Standard Error|Least Squares Mean
2677216|NCT01434654|Secondary|Change in MRS Cerebral Metabolite Ratios in Basal Ganglia|Change in major cerebral metabolites in the basal ganglia, as measured by 1H-Magnetic Resonance Spectroscopy (MRS), after a 12 month period of observation. Spectra were acquired on a Phillips Achieva 3T MRI scanner using point-resolved spectroscopy (PRESS) sequence with short echo time (TE). jMRUI/AMARES algorithm was used to process spectra. Metabolite ratios were calculated for the following metabolites: N-acetyl aspartate (NAA), choline (Cho), creatine (Cr), myo-inositol (mIo), in relation to internal water (H20) as standard.|Baseline and 12 months|n=1 participant in high CNS penetrance arm did not return for 12-months follow-up visit. Their baseline data were therefore excluded from analysis.|||Ratio||Standard Error|Least Squares Mean
2677217|NCT01434654|Primary|Change in Neurocognitive Functioning|Change in overall neurocognitive performance, defined as a global neurocognitive z-score, after a 12-month period of observation, between HIV positive patients taking antiretroviral regimens categorized as being either of high or low CNS penetration. To derive this score, 1) raw scores obtained from a 5-domain brief neurocognitive battery were converted to age-corrected z-scores (M=0, Standard Deviation=1) and 2) the set of individual subtest z-scores were averaged to generate a single composite (global) z-score for each subject. Lower (negative) scores therefore indicate greater levels of cognitive impairment.|Change from baseline Neuropsychological testing at 6 and 12 months|Modified intent-to-treat analysis. All enrolled participants were included aside n=2 low CNS penetrance with baseline data only (1 lost to follow-up, 1 withdrew before 6-months).|||Global neurocognitive z-score||Standard Error|Least Squares Mean
2677218|NCT01434641|Secondary|Rest/Stress Myocardial Count Density Ratio|"The rest and stress myocardial count densities are determined automatically using Evolution software on the GE Healthcare Xeleris Nuclear Medicine computer workstation. The ratio is calculated by simple division.~Please not that patient outcomes are NOT measured in this research protocol."|immediately following SPECT image processing (1 hour after the test)|||||||
2677219|NCT01434641|Primary|Myocardial Perfusion SPECT Image Quality 16 Minutes|"SPECT image quality realized using the stress/rest single-day protocol: 16- minute post-stress acquisitions If myocardial image quality is equivalent or superior to that encountered with standard myocardial perfusion SPECT performed using a standard low-dose rest/high-dose SPECT protocol and OSEM processing and if the rest/stress myocardial count density ratio is > 3.5 the outcome of a particular patient is judged to be favorable (acceptable).If either image quality is poor or if the rest/stress count density ratio is less than 3.5, the outcome is judged unfavorable."|at 16 minutes|Of the total 102 patients enrolled, additional 16-minute post-stress SPECT was performed on 37 patients.|||participants|||Number
2677220|NCT01434641|Primary|Myocardial Perfusion SPECT Image Quality 12 Minutes|"SPECT image quality realized using the stress/rest single-day protocol: 12- minute post-stress acquisitions If myocardial image quality is equivalent or superior to that encountered with standard myocardial perfusion SPECT performed using a standard low-dose rest/high-dose SPECT protocol and OSEM processing and if the rest/stress myocardial count density ratio is > 3.5 the outcome of a particular patient is judged to be favorable (acceptable).If either image quality is poor or if the rest/stress count density ratio is less than 3.5, the outcome is judged unfavorable."|at 12 minutes||||participants|||Number
2677221|NCT01434511|Secondary|Anti-host Cell Protein Baby Hamster Kidney (BHK) Antibody Titer.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
2677222|NCT01434511|Secondary|Anti-OBI-1 Antibody Titer.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
2677223|NCT01434511|Secondary|Anti-human Factor VIII Antibody Titer.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
2677224|NCT01434511|Secondary|Efficacy Assessment of OBI-1 in Participants With Anti-human Factor VIII Titers >30 Bethesda Units (BU)||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
2677225|NCT01434511|Secondary|Recovery and Elimination Rate Parameters of OBI-1 in Subjects With Inhibitors Treated With OBI-1 Therapy.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
2677226|NCT01434511|Secondary|Correlation Between the Pre-infusion Anti-OBI-1 Antibody Titers and the Recovery of OBI-1.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
2677227|NCT01434511|Secondary|Correlation Between the Pre-infusion Anti-OBI-1 Antibody Titers, the Total Dose of OBI-1, the Outcome at 24 Hours and the Eventual Control of the Bleeding Episode.||Frame: Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
2677228|NCT01434511|Secondary|Correlation Between Response to OBI-1 Therapy at Specified Time Points and Eventual Control of Serious Bleeding Episodes.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
2677229|NCT01434511|Secondary|Total Number of Infusions of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
2677230|NCT01434511|Secondary|Total Dose of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
2677231|NCT01434511|Secondary|Frequency of Infusions of OBI-1 Required to Successfully Control Qualifying Bleeding Episodes.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
2677232|NCT01434511|Secondary|Proportion of Bleeding Episodes Responsive to OBI-1 Therapy at Designated Assessment Time Points After the Initiation of Therapy, as Assessed by the Investigator||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
2677233|NCT01434511|Secondary|Overall Proportion of Serious Bleeding Episodes Successfully Controlled With OBI-1 Therapy, as Assessed by the Investigator.||Through 90 days ± 7days following final OBI-1 dose|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
2677234|NCT01434511|Primary|Proportion of Serious Bleeding Episodes Responsive to OBI-1|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, the study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within the OBI-1-302 study (Congenital Hemophilia A).|24 hours after initiation of treatment|This study was terminated early and only enrolled one participant. Due to concerns that the participant would be at risk of being re-identified, study results are not posted. The decision to terminate this study was not related to any safety and/or efficacy concern of OBI-1 in the indication described within this study (Congenital Hemophilia A).||||||
2677235|NCT01434342|Primary|Adherence|Adherence is measured by the percentage of randomized participants who have a Quitline call. Note that this outcome is only defined for the Intervention arm|24 weeks|All randomized participants|||Participants|||Count of Participants
2677236|NCT01434342|Primary|Feasibility of a Smoking Cessation Intervention Among Cancer Patients|The primary feasibility measures are retention and adherence. This outcome, retention, is the percentage of patient who remain in the study for 24 weeks.|24 Weeks|All randomized participants|||Participants|||Count of Participants
2677237|NCT01434290|Secondary|Genetic Markers Associated With Normal Tissue Toxicities Resulting From Radiotherapy||Study entry to 5 years from the end of protocol treatment|The biomarker data will not be obtained due to lack of funding therefore no patients have outcome measure data.||||||
2677238|NCT01434290|Secondary|Utilization of Sexual Medications/Devices Questionnaire Response Frequences|"The Utilization of Sexual Medications/Devices questionaire is designed to assess the use of erectile aids among patients treated for prostate cancer. This instrument is used to complement the sexual symptom domain in the EPIC. The number of subjects responding Yes to the following questions are reported: Do you have a penile prosthesis, Have you used an medications or devices to aid or improve erections?. Arms are not compared to each other. One, 2, and 5 years will be entered when they are available."|Baseline and one year from the end of protocol treatment|Eligible patients who started study treatment and completed the questionnaire at baseline and the specified timepoint|||participants|||Number
2677239|NCT01434290|Secondary|Change From Baseline in EQ-5D Scores|The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). Change from baseline is calculated as score at the timepoint of interested - baseline score. One, 2, and 5 years will be entered when they are available. Arms are not compared.|Baseline and one year from the end of protocol treatment|All eligible patients who started study treatment and completed the EQ-5D at baseline and the specified timepoint|||units on a scale||Inter-Quartile Range|Median
2677240|NCT01434290|Secondary|The Percentage of Patients With Reduction From Baseline at One Year in EPIC Hormonal Domain Score That Exceeds 3 Points|The percentage of patients with a reduction in the EPIC hormonal domain score from baseline that exceeds 3 points (baseline - one year > 3). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other.|Baseline and one year from the end of protocol treatment|Eligible patients who started study treatment and completed the specified domain of the EPIC at baseline and one year|||percentage of participants||95% Confidence Interval|Number
2677241|NCT01434290|Secondary|The Percentage of Patients With Reduction From Baseline at One Year in EPIC Sexual Domain Score That Exceeds 11 Points|The percentage of patients with a reduction in the EPIC sexual domain score from baseline that exceeds 11 points (baseline - one year > 11). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other.|Baseline one year from the end of protocol treatment|Eligible patients who started study treatment and completed the specified domain of the EPIC at baseline and one year|||percentage of participants||95% Confidence Interval|Number
2677242|NCT01434290|Secondary|Change From Baseline in EPIC Bowel and Urinary HRQOL as Continuous Variables at One Year|The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life and a positive change from baseline indicating improvement over time. For this endpoint, in each domain, the actual change score calculated as timepoint score - baseline score will be used as the statistic.|Baseline and one year from the end of protocol treatment|Eligible patients who started protocol treatment and completed the respective domain of the EPIC at baseline and one year|||units on a scale||Inter-Quartile Range|Median
2677243|NCT01434290|Secondary|Quality Adjusted Life Years at 5 Years Using the EQ-5D and DFS|Will be reported after five-year data has been obtained.|Registration to 5 years from the end of protocol treatment||2021-06-30|06/2021||||
2677244|NCT01434290|Secondary|Rate of Disease-free Survival (DFS)|The disease-free survival duration will be measured from the date of randomization to the date of documentation of disease progression or until the date of death from any cause. DFS will be estimated for each hypofractionated arm by the Kaplan-Meier method. One, 2, and 5 years will be entered when they are available. Arms are not compared to each other.|Registration to 1 year from the end of protocol treatment|Eligible patients who started protocol treatment|||percentage of participants||95% Confidence Interval|Number
2677935|NCT01426438|Secondary|Change in Triglycerides|Change in Triglycerides (mg/dL) from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||mg/dL||Inter-Quartile Range|Median
2677245|NCT01434290|Secondary|Rate of PSA Failure|Failure occurs when the PSA is first noted to be 2 ng/mL or more than the current nadir value (PSA > current nadir + 2) post RT completion. Only one year results are shown. One, 2, and 5 years from the end of protocol treatment will be entered as they are available. Rate of PSA failure is estimated by the cumulative incidence method. Arms are not compared to each other.|Registration to one year from the end of protocol treatment|Eligible patients who started protocol treatment|||percentage of participants||95% Confidence Interval|Number
2677246|NCT01434290|Secondary|Acute and Late Gastrointestinal (GI) and Genitourinary (GU) Toxicity for Each Arm|Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the adverse event (AE). The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. An acute adverse event is defined as the first occurrence of worst severity of the adverse event ≤30 days after the completion of radiation therapy (RT). The high dose RT arm of Radiation Therapy Oncology Group (RTOG) study RTOG-0126 (NCT00033631) reported 1% of patients experienced grade 3+ GI/GU acute toxicity with no patient experiencing a grade 4 or 5 toxicity. If the lower confidence interval is >1%, then that arm will be further investigated for acceptability. A late adverse event is defined as the first occurrence of worst severity of adverse event >30 days after RT completion. Arms are not compared to each other.|Start of protocol treatment to one year from the end of protocol treatment|Eligible patients who started protocol treatment|||percentage of participants||95% Confidence Interval|Number
2677247|NCT01434290|Primary|The Percentage of Patients With Reduction From Baseline to One-year EPIC Urinary Domain Score That Exceeds 2 Points|The co-primary endpoint is the proportion of patients with a reduction in the Expanded Prostate Cancer Index Composite (EPIC) urinary domain score from baseline to 1 year that exceeds 2 points (baseline - one year > 2). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other.|Baseline and one year from the end of protocol treatment|Eligible patients who started protocol treatment and completed the urinary domain of the EPIC at baseline and one year|||percentage of participants||95% Confidence Interval|Number
2677248|NCT01434290|Primary|Percentage of Patients With Reduction From Baseline to the One-year EPIC Bowel Domain Score That Exceeds 5 Points|The co-primary endpoint is the percentage of patients with a reduction in the Expanded Prostate Cancer Index Composite (EPIC) bowel domain score from baseline to 1 year that exceeds 5 points (baseline - one year > 5). The EPIC is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal). Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. Arms are not compared to each other.|Baseline and one year from the end of protocol treatment|Eligible patients who started protocol treatment and completed the bowel domain of the EPIC at baseline and one year|||percentage of participants||95% Confidence Interval|Number
2677249|NCT01434186|Primary|Mean Change in HbA1c From Baseline to Week 16||16 week short term treatment period||||percentage||Standard Deviation|Mean
2677250|NCT01434121|Secondary|Plasma Cytokine/Chemokine Levels||during time of infusions - 96 hours from time of enrollment|Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results||||||
2677251|NCT01434121|Secondary|Multiple Organ Dysfunction Score||during time of infusion - 96 hours from time of enrollment|Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results||||||
2677252|NCT01434121|Secondary|Length of Time on Vasopressor Medication||during time of infusion - 96 hours from time of enrollment|Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results||||||
2677253|NCT01434121|Secondary|Ventilator-free Days||subject will be followed until discharged from the hospital, has deceased, or study duration has reached 28 days from time of enrollment, whichever is first|Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results||||||
2677254|NCT01434121|Secondary|Duration of Mechanical Ventilation||subject will be followed until mechanical ventilation has been discontinued, the subject has deceased, or study duration has reached 28 days from time of enrollment, whichever is first|Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results||||||
2677255|NCT01434121|Secondary|Intensive Care Unit Length of Stay||subject will be followed until discharged from the ICU, has deceased, or study duration has reached 28 days from time of enrollment, whichever is first|Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results||||||
2677256|NCT01434121|Primary|Number of Patients Who Experienced Ascorbic Acid Infusion Related Arterial Hypotension, Vomiting, or Tachycardia in Septic Patients|There were no instances of arterial hypotension, vomiting, or tachycardia within the study population related to the study drug|during time of infusion- 96 hours from time of enrollment||||participants|||Number
2677257|NCT01434030|Secondary|Willingness to Follow PGASystem Advice|The categories below indicate types of information that could be received from a PGASystem and the percentage of participants who stated that they would follow this type of advice from a PGASystem.|2 hour focus group||||percentage of participants|||Number
2677258|NCT01434030|Primary|Desire to Receive Advice From Personal Glucose Advisory System (PGASystem)|The categories below indicate types of information that could be received from a PGASystem and the percentage of participants who stated that they would like to receive this type of information from a PGASystem.|2 hour focus group||||percentage of participants|||Number
2678237|NCT01424813|Other Pre-specified|Percent Change From Baseline in FEV1 AUC||Day 8|||||||
2677259|NCT01433978|Primary|Change From Baseline in Local Platelet Count for the 6 Month Treatment Period|Platelet responses to avatrombopag was evaluated using the platelet counts determined at local clinical laboratories. Only participants with non-missing data at both baseline and the relevant post-baseline visit are included in the change from baseline summary statistics. Standard deviation is not applicable for some of the categories, from Visit 14 to Visit 22, as the number of participants analyzed for that visit was 1 individual.|Day 5, Day 8, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16, Week 18, Week 19, Week 20, Week 22, Week 23, Week 24, Week 25, Week 26|The Full Analysis Set (FAS) included all participants who were randomized into the study. Only participants with non-missing data at both baseline and the relevant post-baseline visit are included in the change from baseline summary statistics.|||cells x 10^9/L||Standard Deviation|Geometric Mean
2677260|NCT01433913|Secondary|Changes in Serum Fasting Glucose||Baseline and 12 weeks|Data were not collected because insulin is a more relevant outcome measure than glucose||||||
2677261|NCT01433913|Secondary|Changes in Serum SHBG||Baseline and 12 weeks|analysis limited to participants with fasting serum samples|||% change||Inter-Quartile Range|Median
2677262|NCT01433913|Secondary|Changes in Serum Testosterone||Baseline and 12 weeks|analysis limited to participants with fasting serum samples|||% change||Inter-Quartile Range|Median
2677263|NCT01433913|Secondary|Changes in Serum IGF-1/IGFBP-3||Baseline and 12 weeks|analysis limited to participants with fasting serum samples|||% change||Inter-Quartile Range|Median
2677264|NCT01433913|Secondary|Changes in Serum Fasting Insulin||Baseline and 12 weeks|analysis limited to participants with fasting serum samples|||% change||Inter-Quartile Range|Median
2677265|NCT01433913|Secondary|Changes in Serum PSA||Baseline and 12 weeks|Analysis limited to participants with fasting serum samples|||% change||Inter-Quartile Range|Median
2677266|NCT01433913|Secondary|Cell Cycle Regulation in the Prostatectomy Tissue as Assessed by IHC of Retinoblastoma Protein Phosphorylation (p-pRb)||12 weeks|Data were not collected due to budgetary constraints||||||
2677267|NCT01433913|Secondary|AMPK Activation in the Prostatectomy Tissue as Assessed by IHC of p-AMPK||12 weeks|Data were not collected due to budgetary constraints||||||
2677268|NCT01433913|Secondary|Angiogenesis in the Prostatectomy Tissue as Assessed by IHC of CD34||12 weeks|Data were not collected due to budgetary constraints||||||
2677269|NCT01433913|Secondary|mTOR Regulation in the Prostatectomy Tissue as Assessed by IHC of Phospho-p70 S6 Kinase (p-p70S6K)||12 weeks|Participants with tissue sections available from prostatectomy|||% positive cells||Inter-Quartile Range|Median
2677270|NCT01433913|Secondary|Cell Cycle Regulation in the Prostatectomy Tissue as Assessed by IHC of Cyclin D1||12 weeks|Participants with tissue sections available from prostatectomy|||% positive cells||Inter-Quartile Range|Median
2677271|NCT01433913|Secondary|Apoptosis Levels in the Prostatectomy Tissue as Assessed by IHC of Cleaved Caspase 3|Average number of positively stained cells that exhibited nuclear fragmentation from five randomly selected high-power fields (40x) in the tumor region was calculated for each participant|12 weeks|Participants with tissue sections available from prostatectomy|||Number of positive cells||Inter-Quartile Range|Median
2677272|NCT01433913|Secondary|Prostate Tissue Metformin Concentration Levels as Assessed by Liquid Chromatography Tandem Mass Spectrometry||12 weeks|analysis limited to patients with fresh frozen prostatectomy tissue|||ug/g tissue||Inter-Quartile Range|Median
2677273|NCT01433913|Primary|Cell Proliferation in the Prostatectomy Tissue as Assessed by Ki67 Expression Using Immunohistochemistry (IHC)|Data between the two study groups will be compared using a two-group t-test at a two-sided 0.05 level of significance. If the data are not normally distributed, a non-parametric rank-sum test will be utilized.|12 weeks|Participants with tissue sections available from prostatectomy|||% positively stained nuclei||Inter-Quartile Range|Median
2677274|NCT01433731|Primary|Percentage of Patients With Complete or Partial Response as Measured by Change in Lesion Severity Using CAILS (Composite Assessment of Index Lesion Severity)|Response assessed by change in lesion severity using Composite Assessment of Index Lesion Severity (CAILS) Assessment Tool which measures clinical signs of CTCL by erythema; scaling; plaque elevation; hypo- or hyperpigmentation, each on a scale of 0-8; and lesion size (cm2), on a scale of 0 (no lesion; 0 cm2) to 18 (300 cm2). Up to five index lesions are each scored, and a subtotal CAILS score is provided for each index lesion. A total score is calculated by summing these subtotals. Response criteria measure the change in CAILS score from baseline to follow-up as follows: Complete Response (CR): 100% decrease in CAILS score; Partial Response (PR): 50% - 99% decrease in CAILS score; Stable Disease (SD): < 25% increase to < 50% decrease in CAILS score; Progressive Disease (PD) ≥ 25% increase in CAILS score.|Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42||||percentage of participants|||Number
2677275|NCT01433549|Secondary|Mean Non-Invasive Tear Film Break-Up Time (NITBUT)|As assessed by the investigator using a corneal topographer. NITBUT was assessed at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear. A longer tear film break-up time indicates a more stable tear film and may lead to a more comfortable lens-wearing experience.|Hour 12|All participants who participated in both phases of the study.|||Seconds||Standard Deviation|Mean
2677276|NCT01433549|Primary|Mean End-of-Day Comfort|As assessed by the participant using a visual analog scale ranging from 0 (extremely uncomfortable) to 100 (very comfortable and fresh) at the end of each 12-hour (approximate) cycle. During each cycle, contact lenses were worn for 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes. A new pair of contact lenses was dispensed for each 2-hour interval of lens wear.|Hour 12|All participants who participated in both phases of the study.|||Units on a scale||Standard Deviation|Mean
2677277|NCT01433471|Secondary|Change From Baseline of the Simple Clinical Colitis Activity Index at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 Weeks|To assess ulcerative colitis disease activity without requiring endoscopy|Baseline, 2, 4, 6, 8, 10, 14, 16, 18, 20, 22 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.||||||
2678238|NCT01424813|Other Pre-specified|Percent Change From Baseline in FEV1 AUC 0-6||Day 1|||||||
2699806|NCT01247064|Secondary|Rate of Hospitalization||1 day||||percentage of participants|||Number
2677278|NCT01433471|Secondary|Change in Mayo Score From Baseline at 12 Weeks and 24 Weeks|To assess ulcerative colitis disease activity|Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.||||||
2677279|NCT01433471|Primary|Change From Baseline of Gene Expression at 12 Weeks and 24 Weeks as Assessed by Microarray and Real-time Polymerase Chain Reaction Analysis of Pinch Biopsies||Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.||||||
2677280|NCT01433471|Primary|Change From Baseline of Bacterial Composition and Attachment at 12 Weeks and 24 Weeks as Assessed by Real-time Polymerase Chain Reaction and 454 Sequencing of Pinch Biopsies and Stool Specimens||Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.||||||
2677281|NCT01433471|Primary|Change From Baseline of Effector Lymphocyte Populations (Th1, Th2, Th17, and T-regulatory Cells) at 12 and 24 Weeks as Assessed by Flow Cytometry of Peripheral Blood Mononuclear Cells and Isolated Leukocytes From Pinch Biopsies||Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.||||||
2677282|NCT01433471|Primary|Change From Baseline of Mucus Production at 12 Weeks and 24 Weeks as Assessed by Histopathology||Baseline, 12 weeks, 24 weeks|Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.||||||
2677283|NCT01433354|Primary|Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)|"Adverse events were summarized for the open-label treatment period, where the open-label treatment period is defined based on how AEs were collected and reported according to the manner in which participants entered the current study and which treatment (AFQ056 or placebo) they were receiving in the previous study.~AEs which were continuing from the core study or that started after the end of core study but prior to first dose of open-label study medication in the extension study for Category 1 participants are shown under 'Prior to Ext. first dose'.~AEs which started during the open-label treatment period are presented based on the last AFQ056 dose taken on or before the onset date of the AE (25 mg bid; 50 mg bid; 75 mg bid; or 100 mg bid). No efficacy data presented as study was terminated."|Prior to first dose in extension study, Baseline (start of study treatment in extension study) to End of trial|The analysis was performed in the safety set (SS) population, defined as participants who received at least one dose of study medication and had at least one safety assessment occurring after first dose of extension study medication. Here, ‘Number of Participants Analyzed’ signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2677284|NCT01433263|Secondary|Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Stepping Compared to Placebo at Week 4 and 7|Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.|Baseline, Week 4 and Week 7|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.|||percentage change in time (minutes)||Standard Deviation|Mean
2677285|NCT01433263|Secondary|Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Standing Compared to Placebo at Week 4 and 7|Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.|Baseline, Week 4 and Week 7|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.|||percentage change in time (minutes)||Standard Deviation|Mean
2677286|NCT01433263|Secondary|Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Sedentary Taken Compared to Placebo at Week 4 and 7|Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.|Baseline, Week 4 and Week 7|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.|||percentage change in time (minutes)||Standard Deviation|Mean
2677287|NCT01433263|Secondary|Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Number of Steps Taken Compared to Placebo at Week 4 and 7|Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery.|Baseline, Week 4 and Week 7|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.|||percentage change in number of steps||Standard Deviation|Mean
2677288|NCT01433263|Secondary|Percentage Change From Baseline of Bone Mineral Density (BMD) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo at Week 8|Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(BMD at Visit - BMD at Baseline) / BMD at Baseline] * 100.|Baseline, Week 8|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 8|||Percentage Change in BMD||Standard Deviation|Mean
2678239|NCT01424813|Other Pre-specified|Percent Change From Baseline in FEV1 AUC 0-6 Over the 12-week Treatment Period||Day 1, Day 8, Day 85|||||||
2677289|NCT01433263|Secondary|Percentage Change From Baseline in Total Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo: at Week 8|total lean body mass (LBM) is measured by dual energy x-ray absorptiometry (DXA).Percent Change = [(LBM at Visit - LBM at Baseline) / LBM at Baseline] * 100.|Baseline, Week 8|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 8|||Percentage Change in LBM||Standard Deviation|Mean
2677290|NCT01433263|Secondary|Time to Reach the Maximum Concentration After Drug Administration (Tmax)|Blood samples for pharmacokinetic (PK) evaluation were drawn on Day 1 30mg/kg BYM338 (Core)or week 8 Late 30mg/kg BYM338 (when placebo subjects were rolled over to active). Tmax was directly determined from the raw serum concentration-time data.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.|||hr||Inter-Quartile Range|Median
2677291|NCT01433263|Secondary|Maximum Observed Serum Concentration (Cmax)|Blood samples for pharmacokinetic (PK) evaluation were drawn on Day 1 30mg/kg BYM338 (Core)or week 8 Late 30mg/kg BYM338 (when placebo subjects were rolled over to active). PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8|Pharmacokinetics (PK) analysis set: Patients with evaluable PK data.|||ng/ml||Standard Deviation|Mean
2677292|NCT01433263|Secondary|Percentage Change in Body Weight From Baseline at Week 7 and Week 9|Percentage Change in body weight from baseline in killograms (kg) at week 7 and week 9|Baseline, Week 7 and Week 9|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data.|||Percent Change of Weight (kg)||Standard Deviation|Mean
2677293|NCT01433263|Primary|Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8|Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was no more than or equal to 2% at Week 8 was considered responders.|Baseline, week 8|Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 8|||Percentage Change of TMV||Standard Deviation|Mean
2677294|NCT01433250|Secondary|Measure of Disability: Expanded Disability Status Scale (EDSS).|The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) the EDSS steps (ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions.|Baseline to week 97|Not all patients may have been available at all time points for EDSS evaluation|||participants|||Number
2677295|NCT01433250|Secondary|Change in Brain Volume at End of Study.|Change in volume from start to end of study|week 97||||ml||Standard Deviation|Mean
2677296|NCT01433250|Secondary|Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T2 Weighted MRI|Measures of absolute number of gadolinium [Gd]-enhancing lesions on T2-weighted lesions|weeks 13,25,37,53,73 and 97||||lesions||Full Range|Mean
2677297|NCT01433250|Secondary|Number Lesions Measured in the Brain by Magnetic Resonance Imaging. T1 Weighted MRI|Measures of absolute number of gadolinium [Gd]-enhancing lesions on T1-weighted scans|weeks 13,25,37,53,73 and 97||||lesions||Full Range|Mean
2677298|NCT01433250|Secondary|Distribution of Patients With Relapses to End of Study (EOS) (All Subjects)|Description: number of relapses based on neurological assessments and EDSS|week 97||||Participants|||Number
2677299|NCT01433250|Primary|Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments|Safety outcomes will be described in Adverse events section as there was not an efficacy primary outcome|97 weeks||||participants|||Number
2677300|NCT01433172|Secondary|Response Rate|Response according to Response Evaluation in Solid Tumors (RECIST) 1.1. Complete Response (CR): Complete disappearance of all measurable and non-measurable disease; No new lesions. Partial Response (PR): Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. Progressive Disease (PD): 20% or greater increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Stable Disease (SD): Does not qualify for CR, PR, Progression or Symptomatic Deterioration; All target measurable lesions must be assessed using the same techniques as baseline.|Up to 12 Months|All Phase II participants|||Participants|||Count of Participants
2677301|NCT01433172|Primary|Phase II: Progression Free Survival (PFS)|PFS is measured as the time from start of treatment to progression or death. 6 month progression free survival will be estimated from available clinical and radiographic assessments and RECIST 1.1 will be used to make tumor measurements. Progressive Disease (PD) = 20% increase in the sum of the longest diameter of target lesions.|Up to 6 Months|A Phase II participants evaluable at time of analysis.|||months||95% Confidence Interval|Median
2677302|NCT01433172|Primary|Phase I: Recommend Phase II Dose (RPDII)|Highest dose level of GMCD40L vaccine in combination with CCL21 that induced dose limiting toxicity (DLT) in fewer than 33% of patients. DLT: Intervention-specific acute toxicity; i.e., occurrence within 28 days of drug administration, according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), V 4: 1.) that precludes further dose escalation. Participants are entered in cohorts of 3 at the first dose level. Doses are not escalated over the course of treatment of an individual patient. If 2 or more patients experience toxicity in dose level 1 (30X10^6 cells per injection), dose de-escalation will occur. Dose level -1 will be defined by 10 % reduction of cells administered from dose level 1 and follow the same rules. It is not feasible to escalate the dose of the vaccine beyond 30X10^6 cells per injection; therefore the Maximum Tolerated Dose (MTD) may not be reached in this study. In that case, the highest dose level will be used in the phase II component.|Up to 6 Months|All Phase I Participants|||Recommend Phase II Dose Level|||Number
2677340|NCT01432535|Primary|AUC From Time 0 to the Last Measurable Sample (AUC0-last)|AUC0-last is a measure of the total amount of drug in the plasma from the dose to the last measurable sample.|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.|||pg*hr/mL||95% Confidence Interval|Least Squares Mean
2690160|NCT01319721|Secondary|Eye Movement Amplitude (EMA)||One Year||||millimeter|Participants|Standard Deviation|Mean
2677303|NCT01433159|Primary|Change From Baseline in Composite PUSH (Pressure Ulcer Scale for Healing) Score|"Change from baseline in composite wound bed scores measured as the PUSH total score on Day 15. The PUSH Tool v.3.0, which monitors the three critical parameters that are the most indicative of healing, was used in this study. Scales for the three measurements were: Area = 0 (healthy skin) to 10 (>24 cm x cm); Exudate = 0 (non) to 3 (heavy); Tissue type = 0 (epithelial tissue) to 4 (necrotic tissue). All values were summed and final values are the cumulative scores.~Cumulative Scores = 0 (Best possible outcome: healthy skin/epithelial tissue with no exudate) to 17 (Worst possible outcome: wound >24 cm x cm, containing necrotic tissue, with heavy exudate)"|baseline, 14 Days|Per Protocol Population|||scores on a scale||Standard Deviation|Least Squares Mean
2677304|NCT01433107|Secondary|Number of Subjects With Adverse Event|Number of Subjects with adverse event|6 weeks|Number of subject with any adverse events mild or moderate having signed the informed consent. One subject had an adverse event but did not receive any study drug and was not included in the number of subjects started.|||participants|||Number
2677305|NCT01433107|Secondary|Total Clinical Signs and Symptoms (S/S) Scores|"Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale:~0 = absent~= mild~= moderate~= severe In order to calculate the total symptom score, the scores for each individual symptom are added up.~Possible range : 0 to 18"|week 6||||units on a scale||95% Confidence Interval|Mean
2677306|NCT01433107|Primary|Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2)|"Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale:~0 = absent~= mild~= moderate~= severe In order to calculate the total symptoms score the rating for all symptoms are added up.~Possible range 0 to 18"|week 6|Number of success. The discrepancy between number of participants analyzed and participants completed is explained by delayed exclusions (people having negative mycology results received after completion of the study).|||participants|||Number
2677307|NCT01433081|Secondary|Opioid Consumption|Opioid consumption after discharge|24 hours||||miligram morphine equivalents||Inter-Quartile Range|Median
2677308|NCT01433081|Primary|Quality of Recovery Scores Post Operative|Quality of recovery scores post operative. Scored on a scale of 40 (poor recovery) to 200 (good recovery).|24 hours post operative|Two drop outs for either arm were removed from analysis.|||units on scale 40 (low) - 200 (high)||Inter-Quartile Range|Mean
2677309|NCT01433055|Secondary|The Effect of Adjunct Minocycline to Placebo on Global Clinical Improvement of Symptoms.|The Clinical Global Impression Severity score will be used to examine the effect of minocycline compared to placebo. This assessment has 2 items (scored 0-7) with a total minimum socre of 0 and maximum score of 14. The lower the score the better the outcome.|10 Weeks||||units on a scale||Standard Deviation|Mean
2677310|NCT01433055|Secondary|The Effect of Adjunct Minocycline to Placebo to Improve Depressive Symptoms as Measured by the Calgary Depression Scale|The total score of the Calgary Depression Rating Scale will be used to examine the efficacy of minocycline compared to placebo in improving depressive symptoms. This assessment has 9 items (scored 0-3) with a total minimum socre of 0 and maximum score of 27. The lower the score the better the outcome.|10 Weeks||||units on a scale||Standard Deviation|Mean
2677311|NCT01433055|Secondary|The Effect of Minocycline Compared to Placebo to Improve Negative Symptoms as Measured by the Scale for the Assessment of Negative Symptoms (SANS)|Adjunct minocycline will be compared to placebo to test its efficacy in improving negative symptoms of schizophrenia. The Scale for the Assessment of Negative Symptoms (SANS) will be used to test changes in the total SANS score in adjunct minocycline compared to placebo in the 10 week study. This assessment has 22 items (scored 0-5) with a total minimum score of 0 and maximum score of 110. The lower the score the better the outcome.|10 Weeks||||units on a scale||Standard Deviation|Mean
2677312|NCT01433055|Primary|Effect of Minocycline on Cognitive Symptoms as Measured by the MATRICS Consensus Cognitive Battery.|Adjunct minocycline will be compared to placebo to test its efficacy in improving cognitive function. Neuropsychological testing will be done at baseline and endpoint using the MATRICS battery. A composite score as well as individual scores will be will be the primary outcome over the 10 week randomized study. This assessment total minimum score of -10 and maximum score of 80. He higher the score the better the outcome.|10 Weeks||||units on a scale||Standard Deviation|Mean
2677313|NCT01433055|Primary|Brief Psychiatric Rating Scale (BPRS) Positive Symptom Domain Scores Between Minocycline and Placebo.|Adjunct minocycline to clozapine will be compared to placebo to test its efficacy to improve positive psychotic symptoms. The 4 item positive sub factor of the Brief Psychiatric Rating Scale (BPRS) will be the primary outcome over the 10 week randomized study. Total maximum score is 28, and total minimum score is 4. The positive domain score consists of conceptual disorganization (item 4), suspiciousness (item 11) hallucinatory behavior (item 12), and unusual thought content (item 15). All data is reported as the difference between baseline and 10 weeks. The lower the score the better the outcome.|10 Weeks|The BPRS is a scale that measures major psychotic and non psychotic symptoms in persons with psychotic disorders. It is an 4 item scale with a score range of 1-7 on each item. Results are reported as total score. Total maximum score is 28, and total minimum score is 4.|||units on a scale||Standard Deviation|Mean
2677314|NCT01433042|Primary|Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians|precentage of SB3 images that were graded as superior in image quality to SB2 by the physicians|up to 6 months from end of recruitment|"Five (2%) cases were excluded from the efficacy analysis due to the following :~1 patient withdrawn prior to any procedure.~1 patient did not meet the inclusion criteria~3 cases, the capsule remained in the stomach during the entire procedure.~Therefore, 220 cases are included in the efficacy analysis."|||percentage of cases|||Number
2677315|NCT01433016|Primary|PDR Peak|PDR peak - the rate at which the 13C labeled substrate is metabolized, percentage dose recovery.|At study day one after one hour||||percentage of dose recovery||Standard Deviation|Mean
2680011|NCT01405794|Primary|Change In Glucose Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||mg/dl||Standard Deviation|Mean
2677316|NCT01432938|Secondary|Pharmacodynamics: Maximum Observed International Normalized Ratio (INRmax) of Warfarin|Observed INRmax was assessed from venous blood samples collected to determine the response variable INR at predose and at pre-determined intervals after the administration of warfarin.|Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least 1 dose of warfarin with evaluable warfarin INR data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2677317|NCT01432938|Secondary|Pharmacodynamics: Area Under the International Normalized Ratio Curve (AUCINR) of Warfarin|AUCINR was assessed from venous blood samples collected to determine the response variable INR at predose and at pre-determined intervals after the administration of warfarin.|Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least one dose of warfarin with evaluable warfarin INR data.|||ratio||Geometric Coefficient of Variation|Geometric Mean
2677318|NCT01432938|Primary|Pharmacokinetics: Time to Maximum Concentration (Tmax) of R-warfarin and S-warfarin||Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least one dose of warfarin with evaluable warfarin concentration data.|||hours||Full Range|Median
2677319|NCT01432938|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of R-warfarin and S-warfarin||Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least one dose of warfarin with evaluable warfarin concentration data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2677320|NCT01432938|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of R-warfarin and S-warfarin|Area under the concentration versus time curve (AUC) from zero to infinity was determined from plasma concentrations of the S- and R- enantiomers of warfarin.|Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)|Participants who received at least one dose of warfarin with evaluable warfarin concentration data.|||nanograms times hours per milliliter||Geometric Coefficient of Variation|Geometric Mean
2677321|NCT01432886|Primary|Number of Participants With Adverse Events|The number of subjects who developed 'treatment-emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.|From signing of informed consent up to 30 days after participant's last treatment dose or up to approximately 2 years|The safety analysis set included all participants who received at least one dose of study drug and had at least one post dose safety evaluation.|||Participants|||Number
2677322|NCT01432886|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0). DLTs were defined as grade 4 neutropenia persisting for more than 7 days; grade 3 or above febrile neutropenia; grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring blood transfusion; non-hematologic toxicity (excluding toxicity related to neutrophils, leukocytes, lymphocytes, platelets, CD4 lymphocytes, anemia, and bone marrow density) greater than or equal to grade 3 (Exceptions: Dose reduction was not required even when the following conditions were met: grade 3 nausea, vomiting, or diarrhea controllable with anti-emetic or anti-diarrheal medication and abnormal laboratory parameter not requiring treatment); and day 8 administration was delayed or skipped as a result of the subject did not meet the dosing riteria within cycle.|Up to 3 weeks|The DLT analysis set included those participants who received at least one dose of study drug and had a DLT assessment in cycle 1 (3 weeks) without deviations from the eribulin mesylate/trastuzumab dosing regimens and other major protocol prescripts. Participants with a DLT, regardless of this criterion, were also included in the DLT analysis set.|||Participants|||Number
2677323|NCT01432756|Primary|Number of Topics Discussed Between Parent and Child|"Measured using the Parent-Child Communication Scale (communication on sexual and HIV topics that the intervention covers) for both parent and child participants in pre- and post-assessments. This is a measurement of the number of sex and HIV topics discussed. 16 topics were assessed, including how women get pregnant, how to use condoms to prevent pregnancy and HIV, and how to recognize sexual pressure.~For each topic, participants answered yes or no if they discussed it, and then rate between 1-16 to indicate their communication (higher scores mean better communication). The total scores is reported as the sum of the 16 items, and can range from 0-16."|6 months|Each dyad consisted of one parent and their adolescent child. Sixty-six parents and 66 adolescents participated.|||number of sex and HIV topics discussed||Standard Deviation|Mean
2677324|NCT01432626|Primary|Number of Participants Who Had an Abnormal Regional Uptake of I-123 mIBG at Baseline (Acute Phase) and the Number of Participants Who Had an Abnormal I-123 mIBG Uptake on Follow up (Recovery Phase)|Number of participants who had an abnormal regional uptake of I-123 mIBG at baseline (acute phase) and the number of participants who had an abnormal I-123 mIBG uptake on follow up (recovery phase)|During the acute phase (2-5 days with an expected mean 3 days) and after recovery of cardiac function (6 weeks)||||participants|||Number
2677325|NCT01432600|Secondary|Phase II - Occurrence of Possibly Related Adverse Events (AEs)|Phase II: Participants with Grade 3 or 4 adverse events at least possibly related to the study treatment in 5% of participants in the Phase 2 portion, by AE category, assessed by the National Cancer Institute Common Terminology Criteria (NCI CTC) version 4.0.|Up to 48 Months|All Phase II Participants who completed allocated intervention.|||percentage of participants|||Number
2677326|NCT01432600|Secondary|Phase II - Median Overall Survival (OS)|Overall survival per treatment arm. Overall survival is defined as the time from start of treatment to death of any cause.|36 Months|All participants assigned to Arm B and Arm C.|||months||95% Confidence Interval|Median
2677327|NCT01432600|Secondary|Phase II - Median Progression Free Survival (PFS)|Progression free survival per treatment arm. Progressive Disease (PD) requires one of the following, increase of greater than or equal to 25% from baseline in: Serum M-component; Urine M-component; The difference between involved and uninvolved sFLC levels; The size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia.|36 Months|All Phase II Participants.|||months||95% Confidence Interval|Median
2677952|NCT01426386|Secondary|Number and Size of Follicles During Stimulation|Follicular volume at end of stimulation|End of stimulation (up to 16 stimulation days)|mITT population (all randomised and exposed subjects). This is equivalent to the FAS|||cm^3||Standard Deviation|Mean
2677328|NCT01432600|Primary|Phase II - Overall Response Rate (ORR)|Overall response, Minimal Remission (MR) or better per treatment arm, using the uniform response criteria by the International Myeloma Working Group (IMWG) of pomalidomide in combination with high dose dexamethasone with or without cyclophosphamide in participants with relapsed and refractory myeloma. In addition, Minimal response was incorporated in those response criteria as this is a valid endpoint in patients with relapsed or refractory myeloma. MR: 25-49% reduction in serum paraprotein and a 50-89% reduction in urine light chain excretion; A 25-49% reduction in the size of soft tissue plasmacytoma must be demonstrated is applicable.|36 Months|All Phase II Participants.|||percentage of participants||95% Confidence Interval|Number
2677329|NCT01432600|Primary|Phase I - Maximum Tolerated Dose (MTD)|The maximum tolerated dose of oral weekly cyclophosphamide in milligrams (mg), in combination with pomalidomide and dexamethasone. Dose Escalation of Cyclophosphamide, orallly (PO) days 1, 8, 15 as follows: Level 1: 300 mg; Level 2: 400 mg; Level 3: 500 mg. The period for assessment of Dose Limiting Toxicity (DLT) is the first cycle (28 days). The following toxicities will be considered dose limiting if encountered only in the phase I portion of the study: Febrile neutropenia; Grade 3 or 4 non-hematologic toxicity related to treatment with pomalidomide or cyclophosphamide; Participants must have received optimal symptomatic treatment for Grade 3 or 4 nausea, vomiting, or diarrhea to be considered a DLT; Grade 4 transaminitis; Grade 3 transaminitis must be present for ≥ 7 days to be considered a DLT; Grade 4 thrombocytopenia for 7 or more days; Grade 4 neutropenia for 7 or more days.|28 Days|All Phase I Participants.|||mg|||Number
2677330|NCT01432574|Secondary|Change in Antibody Titers|Change in antibody titers 1 month post-dose 3 of vaccine. For each vaccine component, the geometric mean titers (GMT) and the corresponding 95% confidence intervals (CI) were calculated for antibody titers at each time-point (Day 1 and Month 7). For each participant, the difference in antibody titers between these 2 time-points (titers at Month 7 minus titers at Day 1) was calculated. The mean of antibody titer change and its 95% CI were calculated. Immune response was measured with a multiplex competitive Luminex immunoassay (anti-HPV-6, -11, -16, and -18 chemiluminescence immunoassay analyzer (cLIA); Merck) at Pharmaceutical Product Development (PPD). Briefly, this assay simultaneously quantitates neutralizing antibodies to HPV 6, 11, 16, and 18 in 50 μL of serum. mMU/ml is an arbitrary unit of measure derived after comparing relative inhibition of mAb-PE binding to a pooled standard reference serum using a four-parameter logistic curve fit and correcting for dilution.|Points: Day 1 and Month 7|Participants who had specimens contributing to both Day 1 and Month 7 serum HPV antibody evaluations.|||mMU/mL (geometric mean titer)||95% Confidence Interval|Geometric Mean
2677331|NCT01432574|Primary|Percentage of Participants Seropositive at Month 7|Immune response was measured with a multiplex competitive Luminex immunoassay (anti-HPV-6, -11, -16, and -18 chemiluminescence immunoassay analyzer (cLIA); Merck) at Pharmaceutical Product Development (PPD). Briefly, this assay simultaneously quantitates neutralizing antibodies to HPV 6, 11, 16, and 18 in 50 μL of serum. The seronegative study population at Day 1 (no detectable HPV antibody titers at Day 1) were to be categorized as seroconverted due to increase in titer levels for each vaccine component at Month 7.|7 Months|Participants who had specimens contributing to both Day 1 and Month 7 serum HPV antibody evaluations.|||percentage of participants|||Number
2677332|NCT01432561|Primary|Time to Peak Plasma Cysteamine Concentration (Tmax)|Subjects were randomized to one of two possible treatment sequences using block randomization: Sequence 1 - fasted, high-fat, high-protein or Sequence 2 - high-protein, high-fat, fasted. Sequence assignment determined the treatment condition corresponding to Period I, II & III visits.|0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes, and 3.5, 4, 4.5, 5, 6 hours post‐dose||||minutes||Standard Deviation|Mean
2677333|NCT01432561|Primary|Peak Plasma Cysteamine Concentration (Cmax)|Subjects were randomized to one of two possible treatment sequences using block randomization: Sequence 1 - fasted, high-fat, high-protein or Sequence 2 - high-protein, high-fat, fasted. Sequence assignment determined the treatment condition corresponding to Period I, II & III visits.|0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes, and 3.5, 4, 4.5, 5, 6 hours post‐dose||||uM||Standard Deviation|Mean
2677334|NCT01432561|Primary|Cysteamine Absorption: Area Under the Plasma Concentration Curve (AUC)|Subjects were randomized to one of two possible treatment sequences using block randomization: Sequence 1 - fasted, high-fat, high-protein or Sequence 2 - high-protein, high-fat, fasted. Sequence assignment determined the treatment condition corresponding to Period I, II & III visits.|0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180 minutes, and 3.5, 4, 4.5, 5, 6 hours post‐dose||||min*uM||Standard Deviation|Mean
2677335|NCT01432535|Primary|Apparent Volume of Distribution (Vd/F)|Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.|||Liters||95% Confidence Interval|Geometric Mean
2677336|NCT01432535|Primary|Apparent Total Body Clearance (CL/F)|CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.|||mL/min||95% Confidence Interval|Number
2677337|NCT01432535|Primary|Apparent Terminal Half-life (T1/2)|T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2677338|NCT01432535|Primary|Time to Maximum Observed Serum Concentration (Tmax)|Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.|From hour 0 (pre-dose) up to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.|||hours||95% Confidence Interval|Median
2677339|NCT01432535|Primary|Maximum Observed Serum Concentration (Cmax)|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.|From hour 0 (pre-dose) to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.|||pg/mL||95% Confidence Interval|Geometric Mean
2690161|NCT01319721|Secondary|Healing Time of Corneal Epithelial Defect||Four Weeks||||days|Participants|Standard Deviation|Mean
2677341|NCT01432535|Primary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)|AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.|From hour 0 (pre-dose) to 288 hours post-dose|All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.|||pg*hr/mL||95% Confidence Interval|Least Squares Mean
2677342|NCT01432457|Secondary|Change From Baseline on the Arizona Sexual Experiences (ASEX) Scale Total Score|"The ASEX scale has 5 items to assess sexual functioning with a 1-week recall period. The 5 items assess sex drive, ease of arousal, ease of erection/lubrication, ease of orgasm and orgasm satisfaction. Subjects were encouraged to complete all 5 items regardless of sexual activity during the past week. However, all analyses utilized only the data for the visits where the presence of sexual activity was indicated.~Each individual score ranged from 1 to 6; the total score (based on the sum of the individual items) ranged from 5 to 30; higher scores indicated worse sexual function."|Baseline to Week 8 (final on-therapy)|Safety population: randomized subjects who have taken at least 1 dose of double-blind investigational product. Imputation technique: ASEX scale total score analyzed using analysis of covariance based on LOCF data. ASEX data only analyzed for subjects indicating sexual activity at baseline and a timepoint during post-baseline.|||Units on a scale||Standard Error|Mean
2677343|NCT01432457|Secondary|Hamilton Rating Scale for Depression, 17-item (HAM-D17) Remission Rate|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score of ≤ 7.|Baseline to week 8 (final on-therapy)|Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least one post-baseline HAM-D17 total score. Imputation technique: A logistic regression model based on last- observation-carried-forward (LOCF) data was used.|||percentage of the number of participants|||Number
2677344|NCT01432457|Secondary|Hamilton Rating Scale for Depression, 17-item (HAM-D17) Response Rate|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) total score.|Baseline to Week 8 (final on-therapy)|Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least one post-baseline HAM-D17 total score. Imputation technique: A logistic regression model based on last-observation-carried-forward (LOCF) data was used.|||percentage of the number of participants|||Number
2677345|NCT01432457|Secondary|Change From Baseline on the Clinical Global Impression-Severity (CGI-S) Score|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state.|Baseline to Week 8 (final on-therapy)|Intent-to-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: Analysis of covariance (ANCOVA) was used based on last-observation-carried-forward (LOCF) data.|||Units on scale||Standard Error|Mean
2677346|NCT01432457|Secondary|Change From Baseline on the Clinical Global Impression-Severity Score (CGI-S)|CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = worse state.|Baseline to Week 8 (final on-therapy)|Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: A mixed effects model for repeated measures (MMRM) was used with the baseline CGI-S score as a covariate.|||Units on scale||Standard Error|Mean
2677347|NCT01432457|Secondary|Change From Baseline on the Clinical Global Impression Scale-Improvement (CGI-I)|CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = worse outcome.|Baseline to Week 8 (final on-therapy)|Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: The Cochran-Mantel-Haenszel row-mean-score-difference test using ridit scores based on last-observation-carried-forward (LOCF) data.|||number of participants|||Number
2677348|NCT01432457|Primary|Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline|Baseline to Week 8 (final on-therapy)|Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: Analysis of covariance (ANCOVA) was used based on last-observation-carried-forward (LOCF) data.|||Units on a scale||Standard Error|Mean
2677349|NCT01432457|Primary|Change From Baseline on the Hamilton Rating Scale for Depression, 17-item Total Score (HAM-D17) at Week 8|HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, and weight loss). Each item is scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), for a maximum total score of 52; higher scores indicate more depression. Change from baseline: score at observation minus score at baseline.|Baseline to Week 8 (final on-therapy)|Intent-To-Treat (ITT) population: randomized subjects who have taken at least 1 dose of double-blind investigational product, and had a baseline and at least 1 post-baseline HAM-D17 total score. Imputation technique: A mixed effects model for repeated measures (MMRM) was used with the baseline HAM-D17 score as a covariate.|||Units on a scale||Standard Error|Mean
2690162|NCT01319721|Secondary|Complications||One year||||eyes|Participants||Number
2677350|NCT01432444|Secondary|Mean Clinical Global Impression-Improvement Score (CGI-I) by Week.|The efficacy of trial medication was rated for each participant using the CGI-I scale. The study physician would rate the participants total improvement whether or not it was entirely due to drug treatment. All responses were compared to the participants condition at Baseline of the appropriate phase. The CGI-I during Phase B were assessed relative to the participants condition at the Phase B Baseline visit. Response choices included: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse.|Week 4, 12 and 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.|||Units on a scale||Standard Deviation|Mean
2677351|NCT01432444|Secondary|Change From Baseline in Clinical Global Impression-Severity Score (CGI-S).|"The severity of illness for each participant were rated using the CGI-S scale. To assess CGI-S, study physician were to answer the following question: Considering your total clinical experience with this particular population, how mentally ill is the patient at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients."|Baseline to Week 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.|||Units on a scale||Standard Deviation|Mean
2677352|NCT01432444|Secondary|Change From Baseline in PANSS Negative Subscale Score.|The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The 7 negative symptom constructs are blunted affect, emotional withdrawal, poor rapport, passive pathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.|||Units on a scale||Standard Deviation|Mean
2677353|NCT01432444|Secondary|Change From Baseline in PANSS Positive Subscale Score.|The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity suspiciousness/ persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).|Baseline to Week 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.|||Units on a scale||Standard Deviation|Mean
2677354|NCT01432444|Secondary|Change From Baseline in PANSS (Positive and Negative Syndrome Scale) Total Score.|The PANSS consists of three subscales with a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicates (absence of symptoms) and a score of 7 indicates (extremely severe symptoms). The symptom constructs for each subscale are as follows: 7 Positive subscale symptom constructs, 7 Negative subscale symptom constructs and 16 General Psychopathology subscale symptom constructs. The PANSS total score ranges from 30 to 210.|Baseline to Week 24|The core dataset for all efficacy analyses is the ITT dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.|||Units on a scale||Standard Deviation|Mean
2677355|NCT01432444|Primary|Number of Inpatient Psychiatric Hospitalization for Retrospective Period (Months 4-6) and Prospective Period (Months 4-6).|The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥ inpatient psychiatric hospitalizations) between the retrospective period months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot. Open-label Aripiprazole IM Depot Treatment Phase 3-month Completer sample comprised of all participants who entered open-label aripiprazole IM depot treatment Phase and completed at least 3 months of treatment. This sample was used for the primary endpoint analysis (N=336).|Retrospective period Months 4-6; Prospective period Months 4-6|The core dataset for all efficacy analyses is the Intent-to-Treat (ITT) dataset which consisted of data from all participants who entered Phase B regardless of receiving a dose in the Open-label Aripiprazole IM Depot Treatment Phase.|||participants|||Number
2677356|NCT01432405|Secondary|Plasma Adipocytokines|the effect of the intervention on plasma adiponectin levels.|one year||||microgram per ml||Standard Error|Mean
2677357|NCT01432405|Primary|Hepatic Fat|The effect of exenatide and pioglitazone on liver fat content after one year of treatment in patients with type 2 diabetes.|one year||||percent of liver fat||Standard Error|Mean
2677358|NCT01432379|Secondary|Incidence Rate of Intractable Migraine|Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of intractable migraine from study enrollment up to 64 weeks. Intractable migraine is a migraine that does not seem to go away.|64 weeks|Treated Population: all patients who received at least 1 dose of botulinum toxin Type A|||events per 1,000 person-months||95% Confidence Interval|Number
2677359|NCT01432379|Primary|Incidence Rate of Dysphagia|Incidence rates are reported for subjects with events per 1,000 person-months and are based on the first reported occurrence of dysphagia from study enrollment up to 64 weeks. Dysphagia is difficulty or discomfort swallowing.|64 weeks|Treated Population: all patients who received at least 1 dose of botulinum toxin Type A|||events per 1,000 person-months||95% Confidence Interval|Number
2677589|NCT01430624|Primary|Alcohol Use Disorders Identification Test (AUDIT)|Total scores range from 0 - 40 with higher scores indicating greater problem severity, post assault at 6 months|6 months|Includes only participants with full scale score information at 6 months|||units on a scale||Standard Deviation|Mean
2677360|NCT01432366|Secondary|Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Concerns Score at Baseline|Correlation between BMQ concerns score and participant's characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants' beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant's characteristics included age, height, weight, BMI, time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery.|Baseline|BAS included all participants who were enrolled in the study and seen at baseline. Here, ‘n’ signifies those participants who were evaluable for the specified characteristics.|||correlation coefficient||95% Confidence Interval|Number
2677361|NCT01432366|Secondary|Correlation Between Demographic and Clinical Factors and Beliefs About Medicines Questionnaire Necessity Score at Baseline|Correlation between BMQ necessity score and participant's characteristics (demography and clinical factors) was assessed by using Pearson correlation coefficient. BMQ consists of two 5-item scales assessing participants' beliefs about necessity of prescribed medication for controlling disease (BMQ necessity) and their concerns about potential adverse consequences of taking it (BMQ concerns). Respondents indicate their degree of agreement with each statement on five-point Likert scale, ranging from 1=strongly disagree to 5=strongly agree. Total scores for necessity and concerns scales were summed; range from 5 to 25. Higher scores = stronger beliefs. Participant's characteristics included age, height, weight, body mass index (BMI), time since first RA symptoms, diagnosis, number of comorbidities and number of joint replacement or surgery.|Baseline|BAS included all participants who were enrolled in the study and seen at baseline. Here, ‘n’ signifies those participants who were evaluable for the specified characteristics.|||correlation coefficient||95% Confidence Interval|Number
2677362|NCT01432366|Secondary|Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale at Month 6 and 12|BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity-concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost-benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable for each specified subscales.|||correlation coefficient||95% Confidence Interval|Number
2677363|NCT01432366|Secondary|Pearson Correlation Coefficient Between Beliefs About Medicines Questionnaire and Medication Adherence Rating Scale (MARS) at Baseline|BMQ Necessity and BMQ Concerns are described in outcome measure 1 and 2 respectively. BMQ necessity-concerns: difference between necessity and concerns scales (ranges from -20 to +20, where higher score=better cost-benefit). BMQ Harm scale assesses the degree to which medicines are perceived as harmful. BMQ over use scale assesses beliefs about use of medicines and if they are overprescribed by clinicians. BMQ Harm and overuse scales comprise of 4 items, each item assessed on a 5-point scale (1=strongly disagree to 5=strongly agree). Total BMQ Harm and overuse scores were calculated as the sum of individual items and ranges from 4 to 20. Higher scores =more negative orientation towards medicines. MARS consists of a 5-item scale assessing the frequency of non-adherent behavior of participants for taking medication (5=never, 4=rarely, 3=sometimes, 2=often, 1=very often). Scores for each of the 5 items were summed; ranging from 5 to 25. Higher scores=higher levels of adherence.|Baseline|BAS included all participants who were enrolled in the study and seen at baseline. Here, ‘n’ signifies those participants who were evaluable for each specified subscales.|||correlation coefficient||95% Confidence Interval|Number
2677364|NCT01432366|Secondary|Change From Baseline in Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 12|BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).|Baseline, Month 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||percentage of participants|||Number
2677371|NCT01432366|Secondary|Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Safety at Month 12|Correlation between BMQ concerns score and safety was assessed by using Spearman correlation coefficient. BMQ Concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.|Month 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||correlation coefficient||95% Confidence Interval|Number
2678980|NCT01416272|Primary|Comfort|Symptoms and complaints measured on an analog scale|4 visits over 1 year|DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.||||||
2677365|NCT01432366|Secondary|Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Month 6 and 12|BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||percentage of participants|||Number
2677366|NCT01432366|Secondary|Percentage of Participants Agreeing or Strongly Agreeing With Beliefs About Medicines Questionnaire at Baseline|BMQ consists of two 5-item scales assessing participants' agreement or strong agreement with beliefs about BMQ necessity and BMQ concerns. The items were: BMQ1: Necessity (my health at present depends on my medicines); BMQ2: Concern (having to take medications worries me); BMQ3: Necessity (my life would be impossible without my medications); BMQ4: Concern (I sometimes worry about the long term effects of my medications); BMQ5: Necessity (without my medications I would be very ill); BMQ6: Concern (my medications are mystery to me); BMQ7: Necessity (my health in the future will depend on my medications); BMQ8:Concern (my medications disrupt my life); BMQ9: Necessity (I sometimes worry about becoming too dependent on my medications); BMQ10: Concern (my medications protect me from becoming worse); BMQ11: Necessity (these medicines cause to me unpleasant adverse events).|Baseline|BAS included all participants who were enrolled in the study and seen at baseline. Here 'n' signifies those participants who were evaluable for the given sub-scale items.|||percentage of participants|||Number
2677367|NCT01432366|Secondary|Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Safety|Correlation between evolution of BMQ concerns score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in BMQ concerns score and safety score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable at each specified time point.|||correlation coefficient||95% Confidence Interval|Number
2677368|NCT01432366|Secondary|Correlation Between Evolution of Beliefs About Medicines Questionnaire Concerns and Disease Activity Score Based on 28 Joints Count|Correlation between evolution of BMQ concerns score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ concerns score at Month 6 and 12. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 [very well] to 100 mm [extremely bad]). DAS28 <=3.2= low DA; >3.2 to <=5.1= moderate DA; >5.1=high DA; <2.6=remission.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable at specified time point.|||correlation coefficient||95% Confidence Interval|Number
2677369|NCT01432366|Secondary|Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Safety|Correlation between evolution of BMQ necessity score and safety was assessed by calculating Spearman correlation coefficient between change from baseline in safety score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported AEs considered related to anti-TNF- alpha therapy.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable at specified time point.|||correlation coefficient||95% Confidence Interval|Number
2677370|NCT01432366|Secondary|Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Disease Activity Score Based on 28 Joints Count|Correlation between evolution of BMQ necessity score and DAS28 score was assessed by calculating Pearson correlation coefficient between change from baseline in DAS28 score and BMQ necessity score at Month 6 and 12. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 [very well] to 100 mm [extremely bad]). DAS28 <=3.2= low DA; >3.2 to <=5.1= moderate DA; >5.1=high DA; <2.6=remission.|Month 6, 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘n’ signifies those participants who were evaluable at specified time point.|||correlation coefficient||95% Confidence Interval|Number
2677460|NCT01431716|Primary|Change in Total Pulmonary Resistance From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values|||dyn/sec/cm^5||Standard Deviation|Mean
2691227|NCT01312766|Secondary|Controlled Ovarian Stimulation Duration (Days)||up to 23 days after treatment start||||days||Standard Deviation|Mean
2677372|NCT01432366|Secondary|Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Disease Activity Score Based on 28 Joints Count at Month 12|Correlation between BMQ concerns score and DAS28 score was assessed by using Pearson correlation coefficient. BMQ concerns is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of SJC; TJC using 28 joints count, ESR (mm/hour) and participant's assessment of DA on VAS (range 0 [very well] to 100 mm [extremely bad]). DAS28 <=3.2= low DA; >3.2 to <=5.1= moderate DA; >5.1=high DA; <2.6=remission.|Month 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||correlation coefficient||95% Confidence Interval|Number
2677373|NCT01432366|Secondary|Correlation Between Beliefs About Medicines Questionnaire Necessity Score and Safety at Month 12|Correlation between BMQ necessity score and safety was assessed by using Spearman correlation coefficient. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). Safety was assessed by analyzing the incidence, type and severity of the reported adverse events (AEs) considered related to anti-TNF- alpha therapy.|Month 12|FAS included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||correlation coefficient||95% Confidence Interval|Number
2677374|NCT01432366|Primary|Correlation Between Beliefs About Medicines Questionnaire (BMQ) Necessity Score and Disease Activity Score Based on 28 Joints Count (DAS28) at Month 12|Correlation between BMQ necessity and DAS28 was assessed by using Pearson correlation coefficient. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of swollen joint count (SJC); tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hour]) and participant's assessment of disease activity (DA) on visual analog scale (VAS) (range 0 [very well] to 100 millimeter (mm) [extremely bad]). DAS28 less than or equal to (<=) 3.2=low DA; greater than (>) 3.2 to <=5.1=moderate DA; >5.1=high DA; <2.6=remission.|Month 12|Full Analysis Set (FAS) included all enrolled participants, who were seen at baseline and had at least 1 subsequent visit. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||correlation coefficient||95% Confidence Interval|Number
2677375|NCT01432327|Secondary|Step Count|Daily number of steps|One Year|||||||
2677376|NCT01432327|Secondary|Stages of Motivational Readiness for Physical Activity|According to The Stages of Motivational Readiness for Change Model (SOC), individuals move through a series of stages as they adopt and maintain a new habit(Prochaska & DiClemente, 1983). Specifically, the stages include Precontemplation, Contemplation, Preparation, Action, and Maintenance.The relevant variables were assessed in a self-administered questionnaire.|One Year|||||||
2677377|NCT01432327|Secondary|Percent of Participants Losing Fat Percentage|The amount of body fat is measured by bioelectrical impedance analysis (BIA).|One Year|||||||
2677378|NCT01432327|Secondary|Daily Energy Expenditure in Physical Activity|Minutes of physical activity. Activities can be classified as moderate-intensity, vigorous-intensity or very vigorous-intensity activities based upon the amount of energy used by the body while doing the activity.|One year|||||||
2677379|NCT01432327|Primary|Physical Activity Level|To account for differences in body size and composition, the 24-hour energy requirement (kcal/day) is expressed as a multiple of the basal metabolic rate per 24 hours by using the PAL value (PAL = total energy expenditure/basal metabolic rate). A desirable PAL includes the regular practice of physical activity at work or in spare time with an intensity and duration that will reduce the risk of becoming overweight and developing a variety of non-communicable chronic diseases usually associated as co-morbidities with obesity. This corresponds to PAL values of 1.75 and higher.|One year|Intention to treat analysis was used and analyses data from all participants, including those who did not complete the study|||Metabolic Equivalent||Standard Deviation|Mean
2677380|NCT01432275|Secondary|Preference Questionnaire (Insulin Calculator Not Activated)|"Result for the question: The meter the subject would change to"|25 days (results recorded after the two 7 day periods)|Subjects used a comparator blood glucose meter for 7 days and a FreeStyle InsuLinx meter for 7 days (insulin calculator deactivated). Subjects then completed a preference questionnaire. Each subject was assigned one of the three competitor systems. Subjects had not previously used either study device. Analysis per protocol.|||participants|||Number
2677381|NCT01432275|Primary|Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method.|Overall user preference of the FreeStyle InsuLinx system as a diabetes management tool when compared against their usual method.|25 days|A comparator blood glucose meter was used for 7 days and a FreeStyle InsuLinx for 7 days (insulin calculator inactive). For the last 10 days a FreeStyle InsuLinx with the insulin calculator activated was used. Each subject was assigned one of the three competitor systems. Subjects had not previously used any study systems. Analysis per protocol.|||participants|||Number
2677398|NCT01432236|Secondary|Hospital Anxiety and Depression Scale (HADS) at Baseline.|HADS: participant rated questionnaire with 2 subscales. HADS-A (anxiety) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D (depression) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
2677382|NCT01432262|Secondary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Pre-Vaccination to 1 Month Post-Vaccination|Geometric mean fold rises (GMFRs) for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from pre-vaccination to 1 month post-vaccination were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.|Pre-vaccination to 1 month (28 to 42 days) after vaccination|EIP: eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result, received no prohibited vaccines, and had no other major protocol violations. Here “N” signifies participants with valid and determinate assay results at both pre-vaccination and post-vaccination.|||fold rise||95% Confidence Interval|Geometric Mean
2677383|NCT01432262|Secondary|Percentage of Participants Achieving Serotype-Specific Opsonophagocytic Activity (OPA) Titer With at Least Lower Limit of Quantification (LLOQ) 1 Month After Vaccination|Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using microcolony OPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ for each serotype: 1=1:18, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13.|One month (28 to 42 days) after vaccination|EIP: eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, and had no other major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2677384|NCT01432262|Primary|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between vaccination and up to 1 month (28 to 42 days) after vaccination that were absent before treatment or that worsened relative to pre-treatment state.|Baseline up to 1 Month (28 to 42 days) after vaccination|Safety Population included all participants who received the vaccine.|||percentage of participants||95% Confidence Interval|Number
2677385|NCT01432262|Primary|Percentage of Participants Reporting Pre-Specified Systemic Events Within 14 Days After Vaccination|Systemic events reported using electronic diary. Fever-Any:>=38 degrees Celsius (C), Mild (M):>=38 to <38.5 degrees C, Moderate(Mod):>=38.5 to <39 degrees C, Severe (S):>=39 to <=40 degrees C, Potentially life threatening:>40 degrees C. Headache, fatigue, muscle pain, joint pain- Any: present, M:did not interfere with activity, Mod:some interference, S:activity prevented. Vomiting- Any:present, M:1-2 times/day (d), Mod:>2/d, S:required intravenous hydration. Diarrhoea- Any:present, M:2-3 loose stools/d, Mod:4-5/d, S:>=6/d. All reports of fever >40 degrees C were confirmed as data entry errors.|Within 14 days after vaccination|Safety Population included all participants who received vaccine. N (Number of Participants Analyzed)=participants reporting yes for at least 1 day or no for all 14 days and n=participants reporting yes for at least 1 day or no for all 14 days for specified systemic event for each group respectively. Participants may be represented in >1 category.|||percentage of participants||95% Confidence Interval|Number
2677386|NCT01432262|Primary|Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination|Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present), Mild (2.5 to 5.0 centimeters [cm]), Moderate (5.1 to 10.0 cm), Severe (>10 cm). Pain at injection site scaled as Any (pain present), Mild (does not interfere with activity), Moderate (interferes with activity), Severe (prevents daily activity).|Within 14 days after vaccination|Safety Population included all participants who received vaccine. N (Number of Participants Analyzed)=participants reporting yes for at least 1 day or no for all 14 days and n=participants reporting yes for at least 1 day or no for all 14 days for specified local reaction for each group respectively. Participants may be represented in >1 category.|||percentage of participants||95% Confidence Interval|Number
2677387|NCT01432262|Primary|Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Vaccination|Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a quantitative functional OPA assay. Confidence intervals (CIs) for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Individual OPA assay values below the assay LLOQ (lower limit of quantification) were set at a titer of 0.5*limit of detection (LOD [8]) = (titer of 4) for the purpose of calculating the OPA GMT.|One month (28 to 42 days) after vaccination|Evaluable Immunogenicity Population (EIP): eligible participants who received vaccine, had blood drawn within the pre-specified time frames, had at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, and had no other major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
2677388|NCT01432236|Other Pre-specified|Health Utilization Assessment (Time for Help no Payment) at Baseline.|The healthcare utilization assessment was used to capture healthcare utilization data at Baseline. This assessment contained 10 questions related to aspects of healthcare services. 'Time for help no payment' refers to time other people spent without receiving payment to help with activities the patient cannot perform due to fibromyalgia.|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Hours||Standard Deviation|Mean
2677389|NCT01432236|Other Pre-specified|Health Utilization Assessment (Total Office Visits, Number of Hospitalizations and Number of Emergency Room Visits) at Baseline.|The healthcare utilization assessment was used to capture healthcare utilization data at Baseline. This assessment contained 10 questions related to aspects of healthcare services.|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Visits||Standard Deviation|Mean
2677590|NCT01430624|Primary|Drug Abuse Screening Test (DAST-10)|total possible scores range from 0 - 10 with higher scores indicating poor functioning, post assault at 6 months|6 months|Only includes participants with complete scale data at 6 months|||units on a scale||Standard Deviation|Mean
2677390|NCT01432236|Other Pre-specified|Work Productivity and Activity Index-Specific Health Problem (WPAI-SHP) Questionnaire at Baseline.|WPAI-SHP assessed work productivity and impairment. It was a participant-rated, six-item questionnaire regarding current employment, hours missed and actually worked, and degree to which a specified health problem affected work productivity and regular activities over the past 7 days. Subscale scores included percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Each subscale score was expressed as an impairment percentage (0-100) where higher numbers indicated greater impairment and less productivity.|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
2677391|NCT01432236|Other Pre-specified|Number of Participants With Categorical Scores on the C-SSRS at Post-Baseline.|"C-SSRS assessed whether participant experienced following:completed suicide (1), suicide attempt (2) (response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (3) (Yes on preparatory acts or behavior), suicidal ideation (4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7) (Yes on Has subject engaged in non-suicidal self-injurious behavior). Below table indicated one participant (10141023) treated with Pregabalin reported preparatory act. However upon study unblinding it was clarified that preparatory act occurred while the participant was taking placebo. Since preparatory act was reported at first visit of Period 2, by convention statistical summaries classified this under Pregabalin treatment."|From Visit 3 to Visit 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Participants|||Number
2677392|NCT01432236|Other Pre-specified|Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline.|"C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (3) (Yes on preparatory acts or behavior), suicidal ideation (4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7) (Yes on Has participant engaged in non-suicidal self-injurious behavior)."|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Participants|||Number
2677393|NCT01432236|Other Pre-specified|Mean PSGA Score at End of Period.|PSGA was a single-item self-rated instrument that measured the participant's overall status on an 11-point numeric rating scale (NRS) ranging from 0 (very poor) to 10 (very good).|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2677394|NCT01432236|Other Pre-specified|Mean Patient Static Global Assessment (PSGA) Score at Baseline.|PSGA was a single-item self-rated instrument that measured the participant's overall status on an 11-point NRS ranging from 0 (very poor) to 10 (very good).|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
2677395|NCT01432236|Secondary|EQ-5D Score at End of Period.|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2677396|NCT01432236|Secondary|Mean EuroQoL 5-Dimensions (EQ-5D) Score at Baseline.|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health).|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
2677397|NCT01432236|Secondary|HADS at End of Period.|HADS: participant rated questionnaire with 2 subscales. HADS-A (anxiety) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D (depression) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2677428|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-EEG at Two Consecutive Visits in the Escalation Phase (EP)|EEG is a diagnostic test for epilepsy. The EEG machine records the brain's electrical activity as a series of waveforms. HV is an activation technique used to provoke seizures during an EEG recording. An approximately 30-minute EEG with HV was performed on participants in a supine position. In the HV test, participants breathed through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute ) for 4 continuous minutes using a pin-wheel provided to them.|Up to Study Week 49|FAS|||Participants|||Number
2677399|NCT01432236|Secondary|Subjective Sleep Questionnaire - Parameter Estimates for Subjective Number of Awakenings Per Night After Sleep Onset at End of Period.|Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective number of awakenings after sleep onset was the subjective estimate of the total number of times the participant awakened during the night until final awakening.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Number of times awakened||Standard Error|Least Squares Mean
2677400|NCT01432236|Secondary|Subjective Sleep Questionnaire - Mean Subjective Total Sleep Time at End of Period.|Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective total sleep time was the subjective estimate of the total amount of time the participant was asleep after lights out until final awakening.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Minutes||Standard Error|Least Squares Mean
2677401|NCT01432236|Secondary|Subjective Sleep Questionnaire - Mean Latency to Sleep Onset at End of Period.|Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective latency to sleep onset was the subjective estimate of the amount of time to fall asleep after lights out.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Minutes||Standard Error|Least Squares Mean
2677402|NCT01432236|Secondary|Subjective Sleep Questionnaire - Mean Subjective Wake After Sleep Onset at End of Period.|Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective wake after sleep onset was the subjective estimate of the total amount of time the participant was awake after initial sleep onset until final awakening.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Minutes||Standard Error|Least Squares Mean
2677403|NCT01432236|Secondary|Subjective Sleep Questionnaire - Mean Sleep Quality at End of Period.|Subjective Sleep Questionnaire included 5 items: participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Subjective rating of quality of sleep during the past night was done by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses was therefore 0-10.|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2677404|NCT01432236|Secondary|Percentage of Participants With >=30% and >=50% Pain Reduction Based on Daily Pain Diary.|Participant with at least a 30% reduction in mean pain score from baseline (at randomization) to the endpoint at the end of each period (Visits 6 and 12) is considered a 30% responder, for the respective period. Similarly, a subject with at least a 50% reduction in mean pain score from baseline (at randomization) to the endpoint at the end of each period (Visits 6 and 12) is considered a 50% responder, for the respective period.|Visits 2, 6, and 12|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Percentage of participants|||Number
2677405|NCT01432236|Other Pre-specified|PGIC at the End of Period 2.|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Because of the crossover design and PGIC recall period (since starting study medication), the Period 1 PGIC data were felt to provide the clearest comparison across treatments, whereas Period 2 PGIC data were felt to have a more complex interpretation. Thus PGIC at End of Period 2 was separately analyzed from PGIC at End of Period 1.|End of Period 2 at Week 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Percentage of Participants|||Number
2677406|NCT01432236|Secondary|Patient Global Impression of Change (PGIC) at the End of Period 1.|PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse).|End of Period 1 at Week 6|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Percentage of participants|||Number
2677407|NCT01432236|Secondary|FIQ Score at End of Period.|This was a 20-item participant reported outcome instrument. It contained 10 subscales, which were combined to yield a total score. The first 11 questions were related specifically to physical functioning subscale, ranging from 0 to 10. The remaining 9 questions assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiety and depression ranging from 0 to 10. The higher values indicated greater impairment. All 20 were combined to form a total score ranging from 0 to 100, provides an estimation of fibromyalgia impact with higher scores indicating more impairment. The severity categorizations for the FIQ are: less than 40 (mild), 40-60 (moderate), and above 60 (severe).|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation. Different number (N) for each category represents participants that were actually treated with pregabalin and placebo during the study.|||Units on a scale||Standard Error|Least Squares Mean
2677408|NCT01432236|Secondary|Fibromyalgia Impact Questionnaire (FIQ) Score at Baseline.|This was a 20-item participant reported outcome instrument. It contained 10 subscales, which were combined to yield a total score. The first 11 questions were related specifically to physical functioning subscale, ranging from 0 to 10. The remaining 9 questions assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiety and depression ranging from 0 to 10. The higher values indicated greater impairment. All 20 were combined to form a total score ranging from 0 to 100, provides an estimation of fibromyalgia impact with higher scores indicating more impairment. The severity categorizations for the FIQ are: less than 40 (mild), 40-60 (moderate), and above 60 (severe).|Baseline|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
2677409|NCT01432236|Primary|Mean NRS Pain Score at End of Period.|"The daily pain diary consists of an 11-point numeric scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Participants describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The endpoint mean pain scores for Period 1 and Period 2 are defined as the mean of the last 7 non-missing daily diary pain ratings while taking study medication in the double-blind phase during Period 1 and Period 2, respectively."|End of each period, at Weeks 6 and 14|ITT population defined as all participants who were randomized, treated (ie, received at least one dose of study medication) and had at least one post-randomization efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2677410|NCT01432171|Primary|Number of Participants With Seizures|Number of Participants that had seizure in a randomized, two-arm, parallel groups of post-operative participants with newly-diagnosed high-grade glioma (HGG)|12 months or first seizure||||Participants|||Count of Participants
2677411|NCT01432145|Secondary|Quality of Life - EuroQol Group, Five Dimensions, Three-level (EQ-5D-3L) Standardized Instrument for Measuring Generic Health Status|Evaluated using the EQ-5D-3L questionnaire at baseline, 3 and 6 months, and at the end of treatment or 12 months, as well as using the ECOG performance status measure after each cycle|At the end of treatment or 12 months|Quality of life could not be analysed due to the low questionnaire completion rate; only two patients (3%) completed the baseline and 12 month follow up QoL questionnaires, , but data could not be reported in the Outcome Measure due to confidentiality issues.||||||
2677412|NCT01432145|Primary|Objective Response Rate to 6-mercaptopurine and Methotrexate (6MP/MTX) in This Patient Population.|"1st stage: If less than 3/30 evaluable patients respond at 8 weeks the trial will be stopped for futility. If 3 or more out of 30 evaluable patients respond then a further 35 patients will be recruited (2nd stage) - this was met.~The proportion of patients responding to treatment (complete response, partial response or stable disease) at the second stage will be presented per Response Evaluation Criteria In Solid Tumours (RECIST) criteria version 1.1 measured radiologically with computerised tomography (CT) and/or magnetic resonance imaging (MRI); the same method is used at baseline and at follow-up: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Patients who yield progressive disease (PD) are classed as non-responders."|8 weeks after start of treatment|Evaluable patients are those patients who complete at least 4 out of 8 weeks of trial medication and are assessed for response as per RECIST v1.1 at 8 weeks. Patient who stop trial medication early due to disease progression are also fully evaluable as they have reached an end point.|||Participants|||Count of Participants
2677413|NCT01432015|Primary|Overall Complete Response Rate|no emetic episodes or rescue therapy following the initiation of chemotherapy|13 months|Study participants included adult, female patients with a histologically confirmed, newly diagnosed gynecologic cancer (e.g., epithelial ovarian, fallopian tube, primary peritoneal cancer or uterine cancer).|||percentage of participants|||Number
2677414|NCT01432015|Secondary|Impact on Daily Living Activities|Proportion of patients reporting no impact on daily living activities following initiation of chemotherapy|13 months|Study participants included adult, female patients with a histologically confirmed, newly diagnosed gynecologic cancer (e.g., epithelial ovarian, fallopian tube, primary peritoneal cancer or uterine cancer).|||percentage of participants|||Number
2677415|NCT01431989|Primary|First-order Rate Constant Associated With the Terminal Portion of the Curve (Kel)|This parameter is estimated via linear regression of time versus log concentration. It allows for the obtainment of estimates of T1/2 (T1/2=ln(2)/Kel) considering the schedule and the detection limits defined.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population|||1/hr||Standard Deviation|Mean
2677416|NCT01431989|Primary|Terminal Half-life (T1/2_Kel)|T1/2_Kel is calculated by using the formula T1/2_Kel = Ln(2)/Kel.T1/2 is of particular use in measuring bioavailability, by measuring the elimination of the product.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population|||hr||Standard Deviation|Mean
2677417|NCT01431989|Primary|Percentage of AUC0-inf That is Due to Extrapolation From the Time of the Last Measurable Concentration to Infinity (AUC%Extrapolation)|The percentage of AUC0-inf that is due to extrapolation from Tlast to infinity (AUC%Extrapolation) is calculated by using the formula AUC_%extrapolation = 100*(AUC0-inf minus AUC0-t)/AUC0-inf. The function of this parameter is to provide information about what percentage of the theoretical curve (AUC0-inf) was possible to determine experimentally (AUC0-t) Therefore, on average, it is expected that the residual area (AUCextrapolation) is not greater than 20%.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population|||percentage||Standard Deviation|Mean
2677418|NCT01431989|Primary|Time of Maximum Observed Concentration (Tmax)|The time of maximum observed concentration (Tmax) is obtained directly from the plasma concentration curve of the drug by non-compartimental method. Tmax is of particular use in measuring bioavailability, by measuring the time at which the maximum concentration is achieved.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods: (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population|||hr||Standard Deviation|Mean
2677419|NCT01431989|Primary|Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) Extrapolated to Infinity (AUC0-inf)|Measurement of AUC0-inf is obtained directly from the plasma concentration curve of drug against time (non-compartmental method). AUC0-inf is calculated from time 0 (prior to administration of medication) extrapolated to infinity, by using the formula AUC0-inf = AUC0-t + Clast/Kel, where Clast is the last measurable concentration, and Kel is the first-order rate constant associated with the terminal portion of the curve. AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Collection points (hrs):0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1[Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population|||ng*hr/mL||Standard Deviation|Mean
2677420|NCT01431989|Primary|Maximum Observed Concentration of Drug Through Time (Cmax)|"Cmax is defined as the maximum or peak concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. Measurement is obtained directly from the plasma concentration curve of the drug (non-compartmental method)."|Collection points (hrs): 0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population|||ng/mL||Standard Deviation|Mean
2677421|NCT01431989|Primary|Area Under the Curve of Plasma Concentration of Drug From Time 0 (Zero) to t (Last Measurable Concentration) (AUC0-t)|The area under the plot of plasma concentration of drug against time (non-compartmental method), after drug administration, is defined as the area under the curve (AUC). AUC0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration). AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; mL, milliliter.|Collection points (hours [hrs]): 0.00; 0.25; 0.50; 0.75; 1.00; 1.25; 1.50; 1.75; 2.00; 2.50; 3.00; 4.00; 5.00; 6.00; 8.00 evaluated in both periods (Day 1 of Period 1 [Day 1 of study]; Day 1 of Period 2 [Day 15 of study])|Entire Study Population|||ng per hour per ml (ng*hr/mL)||Standard Deviation|Mean
2677422|NCT01431976|Secondary|Number of Days With Seizure Episodes Per Week in the Extension Phase (ExP) Overall|Participants were asked to record the seizure codes, seizure duration, and their physical condition in a diary provided.|Extension Week 12 (Extension Visit 1 [Ext-V1], every 12 week after Ext-V1 and until withdrawal|FAS. Only those participants given the indicated dose of investigational product were analyzed.|||Days||Standard Deviation|Mean
2677423|NCT01431976|Secondary|Number of Days With Seizure Episodes Per Week in the Main Study Phase (Fixed Escalation Phase [FEP], Escalation Phase [EP], Maintenance Phase [MP]), and FEP+EP+MP)|Participants were asked to record the seizure codes, seizure duration, and their physical condition in a diary provided. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title)|Up to Study Week 50|FAS|||Days||Standard Deviation|Mean
2677424|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Assessment Point in the Extension Phase (ExP)|HV is an activation technique used to provoke seizures. Participants were instructed to breathe through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes while sitting using a pin-wheel and were observed for clinical signs of seizures like impairment of consciousness; staring; eye enrollment; eye blinking; chewing movements; hand movement; other automatisms; atonic, tonic, clonic components; autonomic components; or any other signs. During the ExP, HV-clinical signs were assessed to confirm a status of seizure free. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title).|Extension Week 24 (Extension Visit 2 [Ext-V2], every 24 weeks after the Ext-V2 and until withdrawal|FAS. Only those participants given the indicated dose of investigational product were analyzed.|||Participants|||Number
2677425|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-EEG at Each Assessment Point in the Extension Phase (ExP)|EEG is a diagnostic test for epilepsy. The EEG machine records the brain's electrical activity as a series of waveforms. HV is an activation technique used to provoke seizures during an EEG recording. An approximately 30-minute EEG with HV was performed on participants in a supine position. In the HV test, participants breathed through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute ) for 4 continuous minutes using a pin-wheel provided to them. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title).|Extension Week 12 (Extension Visit 1 [Ext-V1]), every 24 weeks after Ext-V1 and until withdrawal|FAS. Only those participants given the indicated dose of investigational product were analyzed.|||Participants|||Number
2677426|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs During Week 4 and Week 8 of the Maintenance Phase|HV is an activation technique used to provoke seizures. Participants were instructed to breathe through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes while sitting using a pin-wheel and were observed for clinical signs of seizures like impairment of consciousness; staring; eye enrollment; eye blinking; chewing movements; hand movement; other automatisms; atonic, tonic, clonic components; autonomic components; or any other signs. During the Maintenace Phase, HV-clinical signs were assessed at Visit 1 (Week 4) and Visit 2 (Week 4).|Week 4 and Week 8 of the Maintenance Phase (up to Study Weeks 42 and 46, respectively)|FAS. Only those participants who were dosed with investigational product at the indicated time points were analyzed.|||Participants|||Number
2677427|NCT01431976|Secondary|Number of Participants Who Were Seizure Free as Confirmed by HV-clinical Signs at Each Dose During the Escalation Phase|HV is an activation technique used to provoke seizures. Participants were instructed to breathe through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes while sitting using a pin-wheel and were observed for clinical signs of seizures like impairment of consciousness; staring; eye enrollment; eye blinking; chewing movements; hand movement; other automatisms; atonic, tonic, clonic components; autonomic components; or any other signs. During the Escalation Phase, HV-clinical signs were assessed to confirm a status of seizure free. Only participants data available at the analysis time point were analyzed (represented as n=X, X, X in category title).|Up to Study Week 49|FAS. Only those participants given the indicated dose of investigational product were analyzed.|||Participants|||Number
2679872|NCT01407354|Primary|Number of Participants Demonstrating 10% Change: Arm Ergometer and Lokomat Metabolic Cart VO2 Peak|Peak VO2 via Arm Ergometer and Lokomat with metabolic cart|7 months||||participants|||Number
2677429|NCT01431976|Primary|Number of Participants Who Were Seizure Free as Confirmed by Hyperventilation (HV)-Electroencephalography (EEG) at the End of the Maintenance Phase (MP)|EEG is a diagnostic test for epilepsy. The EEG machine records the brain's electrical activity as a series of waveforms. HV is an activation technique used to provoke seizures during an EEG recording. An approximately 30-minute EEG with HV was performed on participants in a supine position. In the HV test, participants breathed through their mouths deeply and rapidly (at a rate of approximately 20-25 breaths/minute) for 4 continuous minutes using a pin-wheel provided to them.|Week 12 of the Maintenance Phase (up to Study Week 50)|Full Analysis Set (FAS): all participants who took at least one dose of investigational product and contributed data to at least one efficacy measure after the first dosing of investigational product|||Participants|||Number
2677430|NCT01431963|Secondary|Time to the First Seizure in the Maintenance Phase (Across Seizure Types and by Seizure Type)|The time to the first seizure in the Maintenance Phase is measured at the time the first seizure occurred in the Maintenance Phase. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic-clonic seizures are a type of generalized seizure that affects the entire brain.|Weeks 7 to 30|FAS. Only those participants available at the specified time point were analyzed.|||Days||Standard Error|Mean
2677431|NCT01431963|Secondary|Time to Withdrawal/Dropout From the Study (Across Seizure Types and by Seizure Type in Past 6 Months in the Escalation and Maintenance Phases)|Time to withdrawal is defined as the time from the start of treatment until withdrawal from the study. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures which affect only a small region of the brain, often the temporal lobes or hippocampi. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic-clonic seizures are a type of generalized seizure that affects the entire brain.|up to Week 30|FAS. Only those participants available at the specified time point were analyzed.|||Days||Standard Error|Mean
2677432|NCT01431963|Primary|Number of Participants Who Were Seizure Free in the Maintenance Phase (Across Seizure Types and by Seizure Type Within 6 Months Prior to the Start of the Study)|Participants were considered to be seizure free if they did not report any seizures during the Maintenance Phase. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic-clonic seizures are a type of generalized seizure that affects the entire brain.|Weeks 7 to 30|Full Analysis Set (FAS): all participants in the Safety Population (SP) who provided at least one set of efficacy data after the first dosing of investigational product. The SP is comprised of all participants who had taken at least one dose of investigational product. Only those participants available at the specified time point were analyzed.|||participants|||Number
2677433|NCT01431950|Secondary|Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods Over the 24-week Treatment Period|Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning and evening before taking any rescue or study medication and before the peak expiratory flow measurement. A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no symptoms was considered to be symptom free. A 24-hour period was considered as missing if both the day time and night time data were missing or if one was symptom-free but the other was missing. The Baseline value was the average of the values of the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of symptom-free 24-hr periods||Standard Error|Least Squares Mean
2677434|NCT01431950|Secondary|Change From Baseline in Daily Morning (AM) PEF Averaged Over the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily AM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||L/min||Standard Error|Least Squares Mean
2677445|NCT01431755|Secondary|Percentage of Subjects With at Least One Step Improvement on Medicis Midface Volume Scale (MMVS) at 2 Weeks|The severity of midface volume loss or midface contour deficiency was assessed by the investigators using a 4-graded scale, Medicis Midface Volume Scale -MMVS (1, fairly full; 2, mild loss of fullness; 3, moderate loss, slight hollowing; and 4, substantial loss, clearly apparent hollowing). Each score were exemplified by photographic images on the scale. A one grade decrease in score from screening was defined as a treatment success/improvement.The efficacy in terms of Medicis Midface Volume Scale (MMVS) was assessed by the Investigator per treatment group. The two cheeks were evaluated separately. MMVS was assessed at the time points 2 weeks, 3 months, 2 weeks after re-treatment and 6, 9 and 12 months after first treatment.|2 weeks|Intention to treat. 54/54 subjects|||percentage of participants||95% Confidence Interval|Number
2677435|NCT01431950|Secondary|Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 24-week Treatment Period|PEF is a measure of lung function and is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF was measured by the participants using a hand-held electronic peak flow meter each morning and evening prior to the dose of study medication and any rescue albuterol/salbutamol inhalation aerosol use. Change from Baseline (defined as the average of the values of the last 7 days prior to randomization of the participants) was calculated as the value of the averaged daily trough PM PEF over the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Liters/minute (L/min)||Standard Error|Least Squares Mean
2677436|NCT01431950|Secondary|Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods Over the 24-week Treatment Period|The number of inhalations of rescue bronchodilator, albuterol/salbutamol inhalation aerosol, used during the day and night was recorded by the participants in a daily electronic diary (eDiary). A 24-hour period in which a participant's responses to both the morning and evening assessments indicated no use of rescue medication was considered to be rescue free. A 24-hour period was considered as missing if both day time and night time values were missing or if one of the day time or night time values were missing and the other value indicated no use of rescue medication. The Baseline value is the average of the values over the last 7 days of the daily eDiary prior to the randomization of the participant. Change from Baseline was calculated as the averaged value during the 24-week Treatment Period minus the Baseline value. Analysis was performed using ANCOVA with covariates of Baseline, region, sex, age, and treatment.|From Baseline up to Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of rescue-free 24-hr periods||Standard Error|Least Squares Mean
2677437|NCT01431950|Primary|Change From Baseline in Clinic Visit Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Evening clinic visit FEV1 is defined as the clinic visit (pre-bronchodilator and pre-dose) FEV1 measurement taken at the Week 24 clinic visit. Pre-dose and pre-rescue albuterol/salbutamol trough FEV1 were measured electronically by spirometry in the evening at the Baseline through Week 24 clinic visits. The highest of 3 technically acceptable measurements was recorded. Baseline was the pre-dose value obtained at Visit 2. Change from Baseline was calculated as the Week 24 value minus the Baseline value. Analysis was performed using analysis of covariance (ANCOVA) with covariates of Baseline, region, sex, age, and treatment. The last observation carried forward (LOCF) method was used to impute missing data, in which the last non-missing, pre-dose, post-Baseline on-treatment measurement at scheduled clinic visits was used to impute the missing value.|Baseline and Week 24|Intent-to-Treat (ITT) Population: all participants (par.) randomized to treatment who received >=1 dose of study medication, except for the par. of one investigator (excluded after good clinical practice [GCP] issues identified during a site audit). Only those par. with non-missing covariates and post-Baseline FEV1 data were analyzed.|||Liters||Standard Error|Least Squares Mean
2677438|NCT01431846|Primary|See Primary Outcome Description Below|Follow up appointment within 2 weeks of discharge back to their primary care providers at a primary care facility from a tertiary referral center.|Within 2 weeks of discharge||||participants|||Number
2677439|NCT01431794|Secondary|Overall Tumor Response as Determined by Number of Participants With Complete or Partial Response|Number of participants who experienced complete response (CR) or partial response (PR), as defined by RECIST v1.0; where CR is a disappearance of all target lesions and PR is ≥30% reduction of target lesions.|5 years|This measure only applies to the Phase I arms. All 13 subjects participated in the Arm/group: Phase I: gem, nab-paclitaxel, and LDE225-600mg. There were no participants enrolled in other two Arm/group as the study was terminated.|||Participants|||Count of Participants
2677440|NCT01431794|Secondary|Overall Survival|Number of months alive from cycle 1, Day 1 until 5 years post-intervention or death, whichever comes first.|5 years|This measure only applies to the Phase I arms. All 13 subjects participated in the Arm/group: Phase I: gem, nab-paclitaxel, and LDE225-600mg. There were no participants enrolled in other two Arm/group as the study was terminated.|||months||Full Range|Median
2677441|NCT01431794|Primary|Phase II - Resection Rate of Two Preoperative Chemotherapy Regimens in Patients With Borderline Resectable PDA|Number of participants with borderline resectable pancreatic adenocarcinoma (PDA) who undergo resection after therapy|5 years|No data was collected to assess this outcome measure as the study was terminated before Phase II.||||||
2677442|NCT01431794|Primary|Phase I - Safety and Feasibility of Gemcitabine and Nab-Paclitaxel in Combination With LDE-225 as Neoadjuvant Therapy as Measured by Number of Participants Who Tolerated the Maximal Dose of LDE-225|Number of participants who tolerated the maximal dose of LDE-225 in combination with gemcitabine, nab-paclitaxel as neoadjuvant therapy in patients with borderline resectable pancreatic adenocarcinoma (PDA).|5 years|This measure only applies to the Phase I arms. All 13 subjects participated in the Arm/group: Phase I: gem, nab-paclitaxel, and LDE225-600mg. There were no participants enrolled in other two Arm/group as the study was terminated.|||Participants|||Count of Participants
2677443|NCT01431755|Secondary|Number of Subjects Reporting Adverse Event|"Adverse Events (AEs) were collected by open questioning, information obtained from signs and symptoms detected during examination, observed by the study personnel or spontaneous reports from the subjects.~All subjects were injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek."|Up to 12 months|Safety population, 54 subjects.|||participants|||Number
2677444|NCT01431755|Secondary|Number of Subjects Reporting at Least 1 Diary Complaint Related to the Cheek Treated With Restylane SubQ and Restylane SubQ Lidocaine Respectively After Initial Treatment.|A subject diary was completed for 14 days following the initial treatment and the optional re-treatment at the 3-month visit. Each subject was asked to record the presence of bruising, redness, swelling, pain, tenderness and itching.|14 days|Safety Population. 54/54 subjects.|||participants|||Number
2677459|NCT01431716|Primary|Change in Mean Pulmonary Arterial Pressure From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values|||mmHg||Standard Deviation|Mean
2677446|NCT01431755|Secondary|Percentage of Improved Subjects at 2 Weeks After Treatment as Assessed by Use of Global Esthetic Improvement Scale (GEIS)|Esthetic improvement was evaluated by using Global Esthetic Improvement Scale. GEIS was evaluated by comparing current photos with pre-treatment photos and using a 5-graded scale (worse/no change/somewhat improved/much improved/very much improved). A clinically significant global esthetic improvement was defined as a score of somewhat improved, much improved or very much improved. GEIS was assessed by the Investigator and the subject. Each cheek/study product was evaluated separately. GEIS was assessed at the time points 2 weeks, 3 months, 2 weeks after re-treatment and 6, 9 and 12 months after first treatment.|2 weeks|Intention to treat. 54/54 subjects|||percentage of participants||95% Confidence Interval|Number
2677447|NCT01431755|Secondary|Subject Pain Assessment by Visual Analogue Scale (VAS) 15 and 120 Minutes After Treatment.|"Pain was assessed during the first 2 hours after the initial injection of the study products using a 100 mm VAS. The endpoints of the scale were no pain (0 mm) and worst possible pain (100 mm). Pain was assessed at the time points 15, 30, 60, 90 and 120 minutes after injection."|15 and 120 minutes|Intention to treat. 54/54 subjects|||units on a scale||Standard Deviation|Mean
2677448|NCT01431755|Primary|Percentage of Subjects Who Assessed Treatment With Restylane SubQ Lidocaine as Least Painful.|When injection of both cheeks was completed, the subject was asked which treatment was least painful (right cheek/left cheek/both cheeks alike).|When injection of both cheeks were completed|Intention to treat. 54/54 subjects|||percentage of participants||95% Confidence Interval|Number
2677449|NCT01431716|Other Pre-specified|Number of Participants With Adverse Events Leading to Discontinuation of Study Drug From Baseline to EOT.|Adverse events that led to discontinuation of study drug from the start of study treatment until the end of study treatment were recorded.|Approximately 3 months|All-treated set.|||participants|||Number
2677450|NCT01431716|Other Pre-specified|Change in Global Satisfaction Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT.|Patients were required to complete the TSQM-9 questionnaire at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The TSQM-9 is a validated instrument to assess patients' satisfaction with medication, including a three question global satisfaction scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.|||units on a scale||Standard Deviation|Mean
2677451|NCT01431716|Other Pre-specified|Change in Convenience Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT.|Patients were required to complete the TSQM-9 questionnaire at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The TSQM-9 is a validated instrument to assess patients' satisfaction with medication, including a three question convenience scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.|||units on a scale||Standard Deviation|Mean
2677452|NCT01431716|Other Pre-specified|Change in Effectiveness Score of the Abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) From Baseline to EOT.|Patients were required to complete the TSQM-9 questionnaire at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The TSQM-9 is a validated instrument to assess patients' satisfaction with medication, including a three question effectiveness scale. The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.|||units on a scale||Standard Deviation|Mean
2677453|NCT01431716|Other Pre-specified|Change in N-terminal Pro-B-type Natriuretic Peptide (NT proBNP) From Baseline to EOT.|Blood sampling for NT proBNP was performed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.|||ng/L||Standard Deviation|Mean
2677454|NCT01431716|Other Pre-specified|Number of Participants With Improved, No Change, or Worsening of New York Heart Association Functional Class (NYHA FC) From Baseline to EOT.|NYHA FC was assessed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. Disease severity was assessed by NYHA classification of pulmonary arterial hypertension criteria: Class I: no limitation of physical activity (PA). Ordinary PA: no undue dyspnea/fatigue, chest pain, near syncope. Class II: slight limitation of PA. Comfortable at rest. Ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class III: marked limitation of PA. Comfortable at rest. Less than ordinary PA: undue dyspnea/fatigue, chest pain, near syncope. Class IV: inability to carry out PA without symptoms. Right heart failure. Dyspnea/fatigue may even have been present at rest. Discomfort increased by any PA.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.|||participants|||Number
2677455|NCT01431716|Other Pre-specified|Change in Borg Dyspnea Score From Baseline to EOT.|"The Borg dyspnea score was assessed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The Borg scale is a category-ratio scale, commonly used to evaluate the effects of exercise on dyspnea. The original and modified scales have ratio properties ranging from 0 = nothing at all to 10 = very, very severe, with descriptors from 0 to 10. Descriptors have been modified by others so that 10 has been labelled extremely severe, or the worst possible dyspnea imaginable."|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.|||units on a scale||Standard Deviation|Mean
2677456|NCT01431716|Primary|Change in Mean Cardiac Index From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values|||L/min/m^2||Standard Deviation|Mean
2677457|NCT01431716|Primary|Change in Pulmonary Capillary Wedge Pressure From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values. Data was missing for 5 patients.|||mmHg||Standard Deviation|Mean
2677458|NCT01431716|Primary|Change in Mean Right Atrial Pressure From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values|||mmHg||Standard Deviation|Mean
2691228|NCT01312766|Secondary|Positive b-hCG Test||up to 5 weeks after treatment start||||percentage of participants|||Number
2677461|NCT01431716|Other Pre-specified|Change in 6-minute Walk Distance (6MWD) From Baseline to EOT.|The 6MWD was assessed at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT. The 6-minute walk test is a non-encouraged test that measures the distance walked for the duration of 6 min.|Approximately 3 months|All-treated set who had both a baseline and an EOT assessment.|||m||Standard Deviation|Mean
2677462|NCT01431716|Primary|Change in Pulmonary Vascular Resistance From Baseline to End of Treatment (EOT).|Right heart catheterization was performed for cardiac hemodynamic assessment at Screening or Day 1, prior to switch from Flolan® to EFI/ACT-385781A and at EOT.|Approximately 3 months|All treated set without imputation for missing values. Data was missing for 5 patients.|||dyn/sec/cm^5||Standard Deviation|Mean
2677463|NCT01431703|Primary|Accuracy, Sensitivity, and Specificity for Differentiating Neoplastic and Non-neoplastic Lesions||For this training, patients were consecutively enrolled until a total of 45 target and non-target lesions were obtained.||||percentage of lesions||95% Confidence Interval|Number
2677464|NCT01431534|Primary|Area Under the Concentration-Time Curve of Ridaforolimus From Time 0 to 24 Hours (AUC0-24 hr)|AUC is a measure of the amount of drug in the blood over time. Whole blood samples were collected pre-dose (within 5 minutes of ridaforolimus administration) and post-dose at specified time points on Day 5 of the first week of Cycle 1 to determine AUC0-24 hr.|Day 5 of Cycle 1 [28-day cycle]: pre-dose (0.0 hours) and 0.5, 1.0, 2.0, 4.0, 8.0, and 24.0 hours after administration of ridaforolimus|Participants who received all 5 ridaforolimus doses in the first week of 28-day Cycle 1 were analyzed.|||hr*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2677465|NCT01431534|Primary|Number of Participants Experiencing a Dose Limiting Toxicity (DLT) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0)|DLT defined using NCI-CTCAE v.4.0 as any of the following events occurring during the first 28-day cycle that were possibly, probably, or definitely study drug-related: Grade 4 neutropenia for ≥5 days; Grade 3-4 neutropenia associated with fever, antibiotics, or hospitalization for infection; Grade 4 thrombocytopenia for ≥5 days or requiring platelet transfusion; ≥Grade 3 hyperglycemia for ≥5 days despite management; ≥Grade 3 diarrhea for >24 hours despite management; ≥Grade 3 nausea or vomiting despite management; any other Grade ≥3 non-hematological toxicity persisting despite management (except alopecia, transient electrolyte abnormalities, transient Grade 3 liver function test elevations, and Grade 3 neurotoxicity for participants with baseline Grade 3 neurotoxicity); inability to complete DLT assessment period, interruption in dosing for >10 dosing days during DLT assessment period, or any delay in the initiation of the next cycle for >10 dosing days due to any related toxicity.|Cycle 1 (cycle = 28 days)|Participants who completed the first 28-day cycle of therapy with adequate drug exposure (>75% of planned study drug doses, exclusive of doses missed due to related toxicity), or who discontinued from the study due to a related DLT, were evaluable for DLT.|||Participants|||Count of Participants
2677466|NCT01431521|Primary|Number of Participants Who Discontinued Study Drug Due to an AE|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 4 weeks|The AST Population consists of all participants who received at least one dose of the study drug.|||Participants|||Number
2677467|NCT01431521|Primary|Number of Participants Experiencing One or More Adverse Events (AE)|An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.|Up to 10 weeks|All Subjects as Treated (AST) Population consists of all participants who received at least one dose of the study drug.|||Participants|||Number
2677468|NCT01431521|Secondary|Percent Change From Baseline Aspartate Transaminase (AST)|Hepatic steatosis is not uncommonly associated with mild elevations in serum transaminases, including AST, and these elevations may be a marker of more advanced hepatic disease. Serum transaminases were monitored at baseline and once weekly for the duration of the study to permit a better understanding of the time course of potential improvement in hepatic inflammation during the course of this short study.|Baseline and Week 4|The AST Population consists of all participants who received at least one dose of the study drug. One participant in the Placebo group did not have AST data for Day 28.|||Percent change||95% Confidence Interval|Least Squares Mean
2677469|NCT01431521|Secondary|Percent Change From Baseline in Alanine Transaminase (ALT)|Hepatic steatosis is not uncommonly associated with mild elevations in serum transaminases, specifically ALT, and these elevations may be a marker of more advanced hepatic disease. Serum transaminases were monitored at baseline and once weekly for the duration of the study to permit a better understanding of the time course of potential improvement in hepatic inflammation during the course of this short study.|Baseline and Week 4|The AST Population consists of all participants who received at least one dose of the study drug. One participant in the Placebo group did not have ALT data for Day 28.|||Percent change||95% Confidence Interval|Least Squares Mean
2677470|NCT01431521|Primary|Percent Change From Baseline in Hepatic Fat|Hepatic fat content was assessed via magnetic resonance imaging (MRI) prior to first dose administration and following 4 weeks of treatment. Percent change in hepatic fat fraction from baseline was calculated for each of the 9 liver regions separately and then these were averaged to calculate overall percent change from baseline for each participant.|Baseline and Week 4|Per-Protocol (PP) Population consists of those participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.|||Percent change||95% Confidence Interval|Least Squares Mean
2677471|NCT01431508|Primary|Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12|Participants with SiDBP of 95-115 mmHg at the end of Baseline had SiDBP measured after 12 weeks of treatment.|At Baseline and Week 12|Intention-to-Treat|||mm Hg||Standard Deviation|Mean
2677472|NCT01431391|Secondary|Percentage of Participants With Immune Response As Evaluated by IFN-γ ELISPOT Specific for PA2024|A participant was considered to have an immune response it the post-baseline PA2024-specific IFN-g ELISPOT count was >18|Month 24|The immune response population was defined as all randomized subjects who received 3 infusions of sipuleucel-T.|||percentage of participants|||Number
2679873|NCT01407276|Secondary|Number of Participants Withdrawn From Study||Up to Day 15|All participants that received a single 3 mg dose of omarigliptin.|||Participants|||Number
2677473|NCT01431391|Primary|Immune Response at Month 24 as Evaluated by IFN-γ ELISPOT Specific for PA2024|Immune response at month 24 as evaluated by IFN-γ ELISPOT specific for PA2024 following sipuleucel-T/ADT treatment regimens to determine if order of administration impacted immune response.|PA2024 ELISPOT counts at Month 24|The immune response population was defined as all randomized subjects who received 3 infusions of sipuleucel-T.|||IFN-γ ELISPOT (per 300,000 PBMC)||Standard Error|Mean
2677474|NCT01431339|Secondary|Clinical Status|Compare the clinical efficacy at the short term follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs temperature and receipt of other therapy|Follow-Up Visit (day 28)|Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.|||participants|||Number
2677475|NCT01431339|Secondary|>= 20% Reduction in Lesion Area|Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size|48-72 hours after the initiation of study therapy|The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.|||participants|||Number
2677476|NCT01431339|Secondary|Clinical Status|Compare the clinical efficacy at end of treatment visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of other therapy|End of Treatment Visit (Day 14-15)|Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.|||participants|||Number
2677477|NCT01431339|Primary|Early Clinical Efficacy|Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size and temperature|After 48-72 hours of therapy|The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.|||participants|||Number
2677478|NCT01431313|Secondary|Change in Mitochondrial Oxygen Consumption Compared to Baseline After Each Dose of Nitrite|Basal platelet oxygen consumption measured in isolated platelets by extracellular flux analysis (XF24, Seahorse Biosciences, Billerica, MA).|Maximal effect at 15 minutes post 45mg or 90mg inhalation vs Pre dose|Data are reported in each group for the subset in whom this data was collected.|||picomoles O2/min||95% Confidence Interval|Mean
2677479|NCT01431313|Secondary|Change in Pulmonary Artery Occlusion (Capillary) Pullback Nitrite|Linear mixed effects model across all time points and doses relative to baseline. The mixed effects model takes into account all time points combined (repeated measures) and has been extensively described for clinical trials (please see references). In this model, the effect of treatment on hemodynamics (measured at 0, 15, 30, 45, and 60 minutes after 45mg followed by same times after 90 mg dose) was compared with baseline values. We assessed the overall linear trend of treatment. The effect of treatment on hemodynamics in each patient group was assessed separately in mixed-effects models. The reported mean is the change from baseline of pulmonary artery occlusion (capillary) pullback nitrite concentration over all subsequent times and doses (beta from the mixed effects model), and is reported as the mean and 95% confidence interval.|Pre-dose, 15 minutes post 45mg and 90mg inhalation|Data are reported only for WHO Group I PAH and WHO Group III Pulmonary Hypertension (PH), as there was insufficient data for this analysis for WHO Group II PH. Data are reported in each group for the subset in whom this data was collected.|||micromolar||95% Confidence Interval|Mean
2677480|NCT01431313|Secondary|Change in Plasma Nitrite Concentrations in Mixed Venous Blood|Linear mixed effects model across all time points and doses relative to baseline. The mixed effects model takes into account all time points combined (repeated measures) and has been extensively described for clinical trials (please see references). In this model, the effect of treatment on hemodynamics (measured at 0, 15, 30, 45, and 60 minutes after 45mg followed by same times after 90 mg dose) was compared with baseline values. We assessed the overall linear trend of treatment. The effect of treatment on hemodynamics in each patient group was assessed separately in mixed-effects models. The reported mean is the change from baseline of plasma nitrite concentrations in mixed venous blood over all subsequent times and doses (beta from the mixed effects model), and is reported as the mean and 95% confidence interval.|Pre-dose, 15 minutes post 45mg and 90mg inhalation|Data are reported in each group for the subset in whom this data was collected.|||micromolar||95% Confidence Interval|Mean
2677481|NCT01431313|Secondary|Change in Pulmonary Vascular Impedance / Wave Intensity|Characteristic impedance (Zc) which may be related to compliance effects in the large, conduit arteries.|Pre dose and 60 minutes post last dosage inhaled|Data are reported in each group for the subset in whom this data was collected.|||dyne*sec/cm5||95% Confidence Interval|Median
2677482|NCT01431313|Secondary|Change in Systemic Vascular Resistance (SVR)|Linear mixed effects model across all time points and doses relative to baseline. The mixed effects model takes into account all time points combined (repeated measures) and has been extensively described for clinical trials (please see references). In this model, the effect of treatment on hemodynamics (measured at 0, 15, 30, 45, and 60 minutes after 45mg followed by same times after 90 mg dose) was compared with baseline values. We assessed the overall linear trend of treatment. The effect of treatment on hemodynamics in each patient group was assessed separately in mixed-effects models. Since systemic vascular resistance was not normally distributed, it was transformed to natural log prior to analysis. The reported mean is the change from baseline of SVR over all subsequent times and doses (beta from the mixed effects model), and is reported as the mean and 95% confidence interval.|Time zero, 15, 30, 45 and 60 minutes after nebulization of 45mg followed by 90 mg dose||||mmHg⋅min/L||95% Confidence Interval|Mean
2677483|NCT01431313|Secondary|Change in Systemic Blood Pressure (Mean Arterial Pressure, MAP)|Linear mixed effects model across all time points and doses relative to baseline. The mixed effects model takes into account all time points combined (repeated measures) and has been extensively described for clinical trials (please see references). In this model, the effect of treatment on hemodynamics (measured at 0, 15, 30, 45, and 60 minutes after 45mg followed by same times after 90 mg dose) was compared with baseline values. We assessed the overall linear trend of treatment. The effect of treatment on hemodynamics in each patient group was assessed separately in mixed-effects models. The reported mean is the change from baseline of MAP over all subsequent times and doses (beta from the mixed effects model), and is reported as the mean and 95% confidence interval.|Time zero, 15, 30, 45 and 60 minutes after nebulization of 45mg followed by 90 mg dose||||mmHg||95% Confidence Interval|Mean
2692338|NCT01302548|Secondary|Number of Patients Prescribed Oral Antibiotics|Number of patients prescribed oral antibiotics|48 hours||||participants|||Number
2677484|NCT01431313|Secondary|Time to Maximum Pulmonary Vascular Resistance (PVR) Decrease|Time in minutes to maximum PVR decrease. During study procedure, hemodynamics were measured at 0, 15, 30, 45, and 60 minutes after 45 mg followed by same times after 90 mg dose. The time point at which each patient's maximal decrease in PVR occurred was recorded and reported as the mean and standard deviation in each cohort.|0, 15, 30, 45, and 60 minutes after 45 mg followed by same times after 90 mg dose||||minutes||Standard Deviation|Mean
2677485|NCT01431313|Primary|Change in Pulmonary Vascular Resistance (PVR)|Linear mixed effects model across all time points and doses relative to baseline. The mixed effects model takes into account all time points combined (repeated measures) and has been extensively described for clinical trials (please see references). In this model, the effect of treatment on hemodynamics (measured at 0, 15, 30, 45, and 60 minutes after 45mg followed by same times after 90 mg dose) was compared with baseline values. We assessed the overall linear trend of treatment. The effect of treatment on hemodynamics in each patient group was assessed separately in mixed-effects models. Since pulmonary vascular resistance (PVR) was not normally distributed, it was transformed to natural log prior to analysis. The reported mean is the change from baseline of PVR over all subsequent times and doses (beta from the mixed effects model, converted back from natural log to Woods units), and is reported as the mean and 95% confidence interval.|Time zero, 15, 30, 45 and 60 minutes after nebulization of 45mg followed by 90 mg dose||||Woods units||95% Confidence Interval|Mean
2677486|NCT01431300|Secondary|Quantitative Analysis Noise Ratios|"Signal-to-noise and contrast-to-noise ratios were calculated for each central venous segment, to determine the magnitude of difference in each of the three administered doses. The ratio's were calculated as follows:~Signal-to-noise ratio: signal intensity of vessel segment / standard deviation of signal intensity of the background.~Contrast-to-noise ratio = (signal intensity of vessel segment minus signal intensity of adjacent muscle) / standard deviation of signal intensity of the background."|14 weeks||||ratio||Standard Deviation|Mean
2677487|NCT01431300|Primary|Imaging Quality Score|"Two radiologists assessed imaging quality of each central venous segment for each patient, in order to compare imaging quality between each of the three doses administered. The visualization score for each venous segments was as follows:~poor / nondiagnostic~adequate~good~excellent"|14 weeks||||Units on a visualization score scale||Full Range|Mean
2677488|NCT01431287|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 365 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"Mahler TDI focal score on Day 365 From the two twin trials, present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
2677489|NCT01431287|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 85 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"Mahler TDI focal score on Day 85 From the two twin trials, present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
2677490|NCT01431287|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 43 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"Mahler TDI focal score on Day 43 From the two twin trials, present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
2677491|NCT01431287|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 365 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
2692429|NCT01301963|Secondary|Compare Need for Hospitalization During Mobilization Between Mobilization Groups||Day 1|||||||
2677492|NCT01431287|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 85 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
2677493|NCT01431287|Secondary|FVC AUC(0-24h) Response in Sub-set of Patients With 12-hour PFTs on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"FVC AUC(0-24h) was calculated as the area under the FVC- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres.~FVC AUC(0-24h) response was defined as FVC AUC(0-24h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.~Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169|12-hr PFT set|||Litres||Standard Error|Least Squares Mean
2677494|NCT01431287|Secondary|FVC AUC(0-12h) Response in Sub-set of Patients With 12-hour PFTs on Day 169 From Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"FVC AUC(0-12h) was calculated as the area under the FVC- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~FVC AUC(0-12h) response was defined as FVC AUC(0-12h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate. Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169|12-hr PFT set|||Litres||Standard Error|Least Squares Mean
2677495|NCT01431287|Secondary|FEV1 AUC(0-24h) Response in Sub-set of Patients With 12-hour PFTs on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"FEV1 AUC(0-24h) was calculated as the area under the FEV1- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres. FEV1 AUC(0-24h) response was defined as FEV1 AUC(0-24h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.~Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169|12−hr PFT set|||Litres||Standard Error|Least Squares Mean
2677496|NCT01431287|Secondary|FEV1 AUC(0-12h) Response in Sub-set of Patients With 12-hour Pulmonary Function Test (PFT) on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"FEV1 AUC(0-12h) was calculated as the area under the FEV1- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~FEV1 AUC(0-12h) response was defined as FEV1 AUC(0-12h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.~Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169|12 hr PFT set: All patients who have given Informed Consent for the 12-hour PFT testing and had any spirometry measurement after 3-hour and before or at 12-hours post-dose on Days 169 and 170.|||Litres||Standard Error|Least Squares Mean
2677497|NCT01431287|Secondary|Trough FVC Response on Day 365|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677613|NCT01430403|Secondary|Percent Adherence to Asthma Medication, Treatment Steps 2-5: Omalizumab vs. Placebo|Adherence to the study regimen and other asthma treatments, assessed as percent of expected dose taken, by means of study interviews and study physician corroboration.|90 Day outcome period|Intent–to-treat|||percent adherence||Standard Error|Mean
2677614|NCT01430403|Secondary|School Absences (Percent), Treatment Steps 2-4: Omalizumab vs. ICS|The ratio of the number of school days missed over the numbers of school days in session|90 Day outcome period|Intent-to-treat|||Ratio||Standard Error|Mean
2677498|NCT01431287|Secondary|Trough FVC Response on Day 170|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FVC measurements performed at 23h and at 23h 50 min after inhalation of study medication at the clinic visit on the previous day.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23h and at 23h 50 min after inhalation of study medication on day 170|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677499|NCT01431287|Secondary|Trough FVC Response on Day 85|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677500|NCT01431287|Secondary|Trough FVC Response on Day 43|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677501|NCT01431287|Secondary|Trough FVC Response on Day 15|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15|FAS (day 15). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677502|NCT01431287|Secondary|Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 365|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Median
2677575|NCT01430754|Secondary|Maintenance of Entrainment (Cortisol) in Subjects With N24HSWD|Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary cortisol collected over four separate 48 hour periods, approximately 1 week apart, during the run-in and randomized phases of the trial. Maintenance of entrainment is defined as the proportion of subjects who become non-entrained to a 24 hour day after randomization to tasimelteon or placebo. Non-entrainment was defined as having a post-baseline τ value ≥ 24.1 or the lower bound of the 95% CI >24.0.|Approximately 12 weeks||||participants|||Number
2680012|NCT01405794|Primary|Change In Creatinine Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||mg/dL||Standard Deviation|Mean
2677503|NCT01431287|Secondary|Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 169|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169|FAS (day 169). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Median
2677504|NCT01431287|Secondary|Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 85|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC.Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Median
2677505|NCT01431287|Secondary|Forced Vital Capacity (FVC) AUC(0-3h) Response on Day 1|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC.Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment|FAS (day 1). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Median
2677506|NCT01431287|Secondary|Trough FEV1 Response on Day 365|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677507|NCT01431287|Secondary|Trough FEV1 Response on Day 169|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1hr and 10 min pre-dose on day 169|FAS (day 169). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677508|NCT01431287|Secondary|Trough FEV1 Response on Day 85|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1hr and 10 min pre-dose on day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677615|NCT01430403|Secondary|School Absences (Percent), Treatment Steps 2-5:Omalizumab vs. Placebo|The ratio of the number of school days missed over the numbers of school days in session|90 Day outcome period|Intent–to-treat|||Ratio||Standard Error|Mean
2677927|NCT01426438|Secondary|Change in HOMA-IR|Absolute change from week 0 to week 24 in insulin resistance as estimated by HOMA-IR|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||HOMA IR Score||Inter-Quartile Range|Median
2677509|NCT01431287|Secondary|Trough FEV1 Response on Day 43|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677510|NCT01431287|Secondary|Trough FEV1 Response on Day 15|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15|FAS (day 15). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677511|NCT01431287|Secondary|FEV1 AUC(0-3h) Response on Day 365|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365|FAS (on day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677512|NCT01431287|Secondary|FEV1 AUC(0-3h) Response on Day 85|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85|FAS (on day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677513|NCT01431287|Secondary|FEV1 AUC(0-3h) Response on Day 1|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677514|NCT01431287|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274) is the key secondary endpoint.~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 169|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
2677928|NCT01426438|Secondary|Change in Large HDL Particles|Change in Large HDL Particles from week 0 to week 24|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||nmol/L||Inter-Quartile Range|Median
2677515|NCT01431287|Primary|Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.6 (NCT01431287) and 1237.5 (NCT01431274).|"The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 169|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
2677516|NCT01431287|Primary|Trough FEV1 Response on Day 170|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FEV1 measurements performed at 23 h and at 23 h 50 min after inhalation of study medication at the clinic visit on the previous day.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677517|NCT01431287|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the MMRM model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169|The Full analysis set (FAS) included all patients who were randomised, who were dispensed study medication, were documented to have taken any dose of study medication and who had a non-missing baseline and at least one non-missing post-baseline measurement before or at Week 24 for any of the primary and key secondary efficacy endpoints.|||Litres||Standard Error|Least Squares Mean
2677518|NCT01431274|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 365 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 365 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287).~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
2677519|NCT01431274|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 85 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 85 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287).~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 85|FAS|||points on a scale||Standard Error|Least Squares Mean
2677520|NCT01431274|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 43 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 43 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287).~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
2677521|NCT01431274|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 365 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.|Day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
2677522|NCT01431274|Secondary|Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 85 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.|Day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
2677523|NCT01431274|Secondary|FVC AUC(0-24h) Response in Sub-set of Patients With 24-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"FVC AUC(0-24h) was calculated as the area under the FVC- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres.~FVC AUC(0-24h) response was defined as FVC AUC(0-24h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.~Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169.|12−hr PFT set|||Litres||Standard Error|Least Squares Mean
2677524|NCT01431274|Secondary|FVC AUC(0-12h) Response in the Sub-set of Patients With 12-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"FVC AUC(0-12h) was calculated as the area under the FVC- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~FVC AUC(0-12h) response was defined as FVC AUC(0-12h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate. Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169.|12−hr PFT set|||Litres||Standard Error|Least Squares Mean
2677525|NCT01431274|Secondary|FEV1 AUC(0-24h) Response in the Sub-set of Patients With 12-h PFTs on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"FEV1 AUC(0-24h) was calculated as the area under the FEV1- time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres. FEV1 AUC(0-24h) response was defined as FEV1 AUC(0-24h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.~Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h, 23 h, 23 h and 50 min post-dose on Day 169.|12−hr PFT set|||Litres||Standard Error|Least Squares Mean
2677526|NCT01431274|Secondary|FEV1 AUC(0-12h) Response in the Sub-set of Patients With 12-hour Pulmonary Function Test (PFT) on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"FEV1 AUC(0-12h) was calculated as the area under the FEV1- time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.~FEV1 AUC(0-12h) response was defined as FEV1 AUC(0-12h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted mean (SE) were obtained from fitting an ANCOVA model with categorical effect of treatment and baseline as covariate.~Number of participants analyzed are the number of patients contributing to the ANCOVA model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 8 h, 10 h, 12 h post-dose on Day 169.|12 hr PFT set: All patients who have given Informed Consent for the 12-hour PFT testing and had any spirometry measurement after 3-hour and before or at 12-hours post-dose on Days 169 and 170.|||Litres||Standard Error|Least Squares Mean
2677576|NCT01430754|Primary|Maintenance of Entrainment (aMT6s) in Subjects With N24HSWD.|Entrainment is a measure of synchronization of the master body clock to the 24-hour day. The circadian period (τ) was calculated using urinary aMT6s collected over four separate 48 hour periods, approximately 1 week apart, during the run-in and randomized phases of the trial. Maintenance of entrainment is defined as the proportion of subjects who become non-entrained to a 24 hour day after randomization to tasimelteon or placebo. Non-entrainment was defined as having a post-baseline τ value ≥ 24.1 or the lower bound of the 95% CI >24.0.|Approximately 12 weeks||||participants|||Number
2677527|NCT01431274|Secondary|Trough FVC Response on Day 365.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on Day 365.|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677528|NCT01431274|Secondary|Trough FVC Response on Day 170.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FVC measurements performed at 23h and at 23h 50 min after inhalation of study medication at the clinic visit on the previous day.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677529|NCT01431274|Secondary|Trough FVC Response on Day 85.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and on day 85|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677530|NCT01431274|Secondary|Trough FVC Response on Day 43.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677531|NCT01431274|Secondary|Trough FVC Response on Day 15.|"Trough FVC was defined as the FVC value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FVC response was defined as trough FVC minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15|FAS (day 15). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677538|NCT01431274|Secondary|Trough FEV1 Response on Day 85|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed~1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 85.|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677532|NCT01431274|Secondary|FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 365|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365.|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677533|NCT01431274|Secondary|FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 169|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.|FAS (day 169). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677534|NCT01431274|Secondary|FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 85|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC.Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85.|FAS (day 85). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677535|NCT01431274|Secondary|FVC (Forced Vital Capacity) AUC(0-3h) Response on Day 1|"FVC AUC(0-3h) was calculated as the area under the FVC- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FVC AUC(0-3h) response was defined as FVC AUC(0-3h) minus baseline FVC. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment.|FAS (day 1). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677536|NCT01431274|Secondary|Trough FEV1 Response on Day 365|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed~1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on day 365|FAS (day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677537|NCT01431274|Secondary|Trough FEV1 Response on Day 169|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed~1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 1 hr and 10 min pre-dose on Day 169|FAS (day 169). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677539|NCT01431274|Secondary|Trough FEV1 Response on Day 43|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed~1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 43.|FAS (day 43). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677540|NCT01431274|Secondary|Trough FEV1 Response on Day 15.|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), calculated as the mean of the pre-dose measurements.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed~1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 10 min pre-dose on day 15|FAS (day 15). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677541|NCT01431274|Secondary|FEV1 AUC(0-3h) Response on Day 365|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 365 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 365.|FAS (on day 365). Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677542|NCT01431274|Secondary|FEV1 AUC(0-3h) Response on Day 85|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 85 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 85.|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677543|NCT01431274|Secondary|FEV1 AUC(0-3h) Response on Day 1|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres.~FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose of randomised treatment at Day1.~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on the first day of randomized treatment.|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677544|NCT01431274|Secondary|Mahler Transitional Dyspnoea Index (TDI) Focal Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|"Mahler Transitional Dyspnoea Index (TDI) focal score on Day 169 From the Two Twin Trials, present 1237.5 (NCT01431274) and 1237.6 (NCT01431287) is the key secondary endpoint.~The Mahler Dyspnoea questionnaire is an instrument which measures change from the baseline state The TDI focal score was used to measure the effect of Tio+Olo FDC on patients' dyspnoea after 24 weeks of treatment (Day 169). The focal score is the sum of the subscale scores for Functional Impairment, Magnitude of Effort and Magnitude of Task. Scores for each subscale range from -3 to 3 so that the Focal score ranges from -9 to 9. For all subscale scores and the Focal score a higher value indicates a better outcome. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group."|Day 169|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
2677588|NCT01430624|Primary|Cigarettes (Estimated Number)|quantity in 14 days prior to 6 week, 3 month and 6 month follow-up|14 days preceding 6 week, 3 month and 6 month follow-up|1 participant missing 6 week cigarette smoking information|||cigarettes||Standard Error|Mean
2677545|NCT01431274|Primary|Saint George's Respiratory Questionnaire (SGRQ) Total Score on Day 169 From the Two Twin Trials, Present 1237.5 (NCT01431274) and 1237.6 (NCT01431287)|The SGRQ is designed to measure health impairment in patients with COPD. It is divided into 2 parts: part 1 produces the symptoms score, and part 2 the activity and impacts scores. A total score is also produced. Each subscale score is the sum of the weights for the items in the subscale as a percent of the sum of the weights for a patient in the worst possible condition. The total score uses the same calculation except that the weights are summed over the entire questionnaire. The individual subscales as well as the total score can range from 0 to 100 with a lower score denoting a better health status. Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures model (MMRM) in each treatment group.|Day 169|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||points on a scale||Standard Error|Least Squares Mean
2677546|NCT01431274|Primary|Trough FEV1 Response on Day 170.|"Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours) and was calculated as the mean of the 2 FEV1 measurements performed at 23 h and at 23 h 50 min after inhalation of study medication at the clinic visit on the previous day.~Trough FEV1 response was defined as trough FEV1 minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an MMRM including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom.~Number of participants analyzed are the number of patients contributing to the mixed effect repeated measures (MMRM) model in each treatment group."|1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and at 23 h and at 23 h 50 min after inhalation of study medication on Day 170|FAS. Since it is possible for the patient to meet the data criterion for only a subset of the primary endpoints, it is possible that the number of patients used in the FAS analysis for different endpoints will vary.|||Litres||Standard Error|Least Squares Mean
2677547|NCT01431274|Primary|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3h) Response on Day 169.|"FEV1 AUC(0-3h) was calculated as the area under the FEV1- time curve from 0 to 3 h post-dose using the trapezoidal rule, divided by the duration (3 h) to report in litres. FEV1 AUC(0-3h) response was defined as FEV1 AUC(0-3h) minus baseline FEV1. Baseline was defined as the mean of the 2 pre-dose measurements performed 1 h and 10 min prior to administration of the first dose at visit 2 (day 1).~The adjusted means (SE) were obtained from fitting an Mixed effect model repeated measures (MMRM) including fixed effects of treatment, planned test day, treatment-by-test day interaction, baseline and baseline-by-test day interaction, patient as random effect, and spatial power covariance structure for within−patient errors and Kenward-Roger approximation for denominator degrees of freedom. Number of participants analyzed are the number of patients contributing to the MMRM model in each treatment group."|1 hour (h) and 10 minutes (min) prior to dose to on the first day of randomized treatment and on Day 169 and 5 min, 15 min, 30 min, 1 h, 2 h, 3 h post-dose on Day 169.|The Full analysis set (FAS) included all patients who were randomised, who were dispensed study medication, were documented to have taken any dose of study medication and who had a non-missing baseline and at least one non-missing post-baseline measurement before or at Week 24 for any of the primary and key secondary efficacy endpoints.|||Litres||Standard Error|Least Squares Mean
2677548|NCT01431170|Post-Hoc|Number of Subjects Treated Successfully at Close-Out Visit (Week 16)|Treatment Success is defined as a grade of 0 or improvement by 2 or more compared to the prior visit.|Baseline to Week 16 (Close-Out Visit)||||Number of Treatment Success|||Number
2677549|NCT01431170|Secondary|Medication Safety Outcomes|During each study visit, the Principal Investigator will evaluate any possible adverse events by assessing clinical complaints and symptoms that are experienced by subjects and observed by the parent(s)/legal guardian(s), including findings in external, lacrimal duct system and anterior segment using slit lamp and fundus exam using indirect ophthalmoscope by principal investigator, as well as clinical signs including findings in external, nasolacrimal duct system and anterior segment using slit lamp and fundus exam using indirect ophthalmoscope by principal investigator.|Baseline to Week 16 (Closeout Visit )|No safety issues were reported|||Number of Adverse Events|||Number
2677550|NCT01431170|Secondary|Treatment Failure|"Possible treatment failure at a follow-up examination is operationally defined as follows: if the physician-grading scale of NLDO is worse than or same as the prior visit at any given follow-up visit, possible treatment failure then exists.~Treatment Failure occurred if at visit #1 (2-week visit), the physician-grading scale of NLDO is worse than or same as the baseline visit. Treatment failure can also occur at recurrence visit #1 if the NLDO grading scale is worse or the same as compared to the previous visit. Subjects who meet the criteria for treatment failure were withdrawn from the study by the principal investigator and no additional data was collected. Subjects were referred for continued care."|Baseline to the time of failure or Week 16 (Closeout Visit)||||Number of Treatment Failures|||Number
2677551|NCT01431170|Secondary|Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO|"Subjects who experience recurrence were re-treated as if they were a new patient, with the same study medication, were followed up then classified as Treatment Success or Treatment Failure according to study protocol."|Baseline to Week 16 (Closeout Visit)||||participants|||Number
2677552|NCT01431170|Secondary|Number of Recurrences by Randomization Group|"Recurrence is defined as when the NLDO with infection in the subject's study eye returns, as indicated by a NLDO grading scale of greater than zero after achieving a grade of zero at the previous visit.~Number of subjects who had a recurrence event of the subjects who completed the study by treatment Group."|Baseline to Week 16 (Closeout Visit )|The overall study recurrence rate was 10% study-wide (2 of 20 subjects), with one Besivance subject (11%), and one Polytrim subject (9%) experiencing recurrence.|||Recurrence Subjects|||Number
2677574|NCT01430754|Secondary|Change From Run-In in Subjective Nighttime Total Sleep Time in Lower Quartile of Days (LQ-nTST) During the Randomized Phase|LQ-nTST measures the average nighttime sleep during the patient's worst 25% of nights (shortest total nighttime sleep) from run-in and randomized phase. The higher number indicates improvement.|Approximately 12 weeks||||minutes||Standard Error|Mean
2692430|NCT01301963|Secondary|Compare Days of Apheresis Between Mobilization Groups|Using the Wilcoxon Rand Sum Test|Day 1|||||||
2677553|NCT01431170|Primary|Change in Physician-rated Scale of NLDO From Baseline to Follow-Up Visit at Week 8 or From Baseline to Time of Treatment Failure, if Earlier.|"The NLDO grading scale in the study eye at every visit. The scale ranges from 0 to +4:~0: No tearing and discharge.~1: Tearing, moderate mucous discharge around nasolacrimal punctum~2: Moderate redness of the medial eyelid with mucous discharge~3: Redness and swelling of the eyelid with mucopurulent discharge~4: Redness and swelling of eyelid with purulent discharge~Due to varying baseline severity (measured by NLDO grade) among subjects, change from baseline to week 8 in NLDO grade was further classified as the following:~Treatment success: grade of 0 or improvement by 2 or more compared to the prior visit.~Recurrence: NLDO with infection returns in the study eye, as indicated by a NLDO grade >0 after a grade of 0 at the prior visit.~Treatment Failure: grade is worse than or same as the baseline visit."|Baseline to Week 8||||participants|||Number
2677554|NCT01431144|Primary|Soft Tissue Thickness Over the Implant|Soft tissue thickness at the facial osseous crest.|1 year||||mm||Standard Deviation|Mean
2677555|NCT01431131|Secondary|Histologic Healing of the Osseous Graft|Histologic analysis to determine vital bone, nonvital bone, and trabecular space percentages|4 months||||percentage vital bone||Standard Deviation|Mean
2677556|NCT01431131|Primary|Horizontal Ridge Dimension|WIll be measured with a digital caliper at baseline and 4 months.|Baseline and 4 months||||mm||Standard Deviation|Mean
2677557|NCT01431105|Primary|Number of Participants With SAE|Number of participants who experienced an SAE within the 6 week study period|At 6 weeks after initiation of study drug||||Participants|||Count of Participants
2677558|NCT01431079|Secondary|Change From Baseline and After the Interventions to up to 3 Months Follow-up in Score of Self-efficacy for Receiving HPV Vaccine|"Before the interventions and after the interventions the health belief model construct of self-efficacy for receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Self-efficacy for receiving HPV vaccine will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely to 12- very likely). The subscale has acceptable validity and reliability.~The difference between post and pre-test was taken to determine a change score. This score was then used for regressions."|Post interventions and up to 3 months follow-up|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.|||units on a scale||Standard Deviation|Mean
2677559|NCT01431079|Secondary|Change From Baseline to After the Interventions to Follow-up up to 3 Months After the Interventions in Score of Cues to Action to Receiving HPV Vaccine|"Before the interventions, and after the interventions and up to 3 months after the interventions the health belief model construct of cues to action to receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Cues to action to receiving HPV vaccine will be measured as a summative score on a four item Likert subscale with a range of 0 to 16 (0- not at all likely to 16-very likely). The subscale has acceptable validity and reliability.~Difference between post and pre-test were used to obtain a change score. This score was used for regressions."|Post interventions and up to three months after the intervention|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.|||units on a scale||Standard Deviation|Mean
2677560|NCT01431079|Secondary|Change From Baseline to Post Test After the Interventions to Follow-up (up to 3 Months) in the Score of Perceived Barriers to Receiving HPV Vaccine|"Before the interventions, post test after the interventions following the interventions the health belief model construct of perceived barriers to receiving HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Perceived barriers for receiving HPV vaccine will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely to 12- very likely). The subscale has acceptable validity and reliability.~A difference between post-test and pre-test were taken to obtain the score. This score was then used in the regression."|post interventions and up to 3 months after the intervention|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.|||units on a scale||Standard Deviation|Mean
2677561|NCT01431079|Secondary|Change From Baseline to Post Test After the Interventions to up to 3 Month Follow-up in Score of Perceived Benefits of HPV Vaccine|"Before the interventions, after the interventions and one month following the interventions the health belief model construct of Perceived benefits of HPV vaccine scores will be measured on a paper pencil self-report test and changes noted. Perceived benefits of HPV vaccine will be measured as a summative score on a four item Likert subscale with a range of 0 to 16 (0-not very likely and 16- very likely). The subscale has acceptable validity and reliability.~Difference between posttest and pre-test was done. This value was then used to run the multiple regressions."|post intervention and up to 3 months after the interventions|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.|||units on a scale||Standard Deviation|Mean
2677562|NCT01431079|Secondary|Change From Baseline to Post Test to Upto 3 Month Follow-up After the Interventions in Score for Perceived Severity for HPV|"Before the interventions, after the interventions and up to 3 months following the interventions the health belief model construct of perceived severity for HPV scores will be measured on a paper pencil self-report test and changes noted. Perceived severity for HPV will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 to 12 (0- not likely and 12-very likely). The subscale has acceptable validity and reliability.~Difference between posttest and pre-test was done. This value was then used to run the multiple regressions."|Post interventions and up to 3 months after the intervention|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.|||units on a scale||Standard Deviation|Mean
2677563|NCT01431079|Secondary|Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions in Score of Perceived Susceptibility for HPV|"Before the interventions, after the interventions and up to 3 months following the interventions the health belief model construct of perceived susceptibility for HPV scores will be measured on a paper pencil self-report test and changes noted. Perceived susceptibility for HPV will be measured as a summative score on a three item Likert subscale with a range of 0 to 12 (0- not likely and 12-very likely). The subscale has acceptable validity and reliability.~Difference between posttest and pre-test was done. This value was then used to run the multiple regressions."|Post interventions and up to 3 months after the interventions|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.|||units on a scale||Standard Deviation|Mean
2677564|NCT01431079|Primary|Change From Baseline to Post Intervention to Follow-up up to 3 Months After the Interventions the Number of Participants Who Intend to Take HPV Vaccine Using HPV Intent Scale (Possible Range 0-4 Likert Units)|"Before the interventions, post test after the interventions and follow-up 1 to 3 months after the interventions (health belief model based and knowledge based) participants will be asked about their intent to take the HPV vaccine on a scale of 0-4 Likert units and changes noted.~Posttest was conducted immediately after the intervention. Minimum score = 0 indicating no intent to take vaccine; Maximum score = 4 indicating strong intent to take vaccine. Scale was a single item scale."|Post intervention and up to 3 months after the intervention|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.|||units on a scale||Standard Deviation|Mean
2677565|NCT01431079|Primary|Change From Baseline to Post Intervention to Follow-up (up to 3 Months) After the Interventions the Number of Participants Who Have Taken the HPV Vaccine|Before, after and one to three month following the health belief model based educational intervention and knowledge-based educational intervention the participants will be asked if they have taken the first dose of HPV vaccine and changes noted.|Post intervention and up to 3 months after the interventions|A sample size of 90 men total (Erdfleder, Faul, & Buchner, 1996) was needed for the intervention. This was calculated by G*Power based on: alpha= 0.05, power=.80, groups=2, measurements=2, effect size=.20, correlations among repeated measures-0.5, nonsphericity correction ε=1, giving us total sample of 90.|||participants|||Number
2677566|NCT01431014|Primary|Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery|Measure of facial swelling will be performed using 3-dimensional photogrammetry. The 3d photo acquisition is non-invasive without radiation concern. The images will be taken before and after surgery to measure and compare the degree of facial swelling. Side effects from the steroid use are expected to be low under normal clinical dosage, but will also be monitored. Symptoms of wound infection, psychosis, and prolonged wound healing will be studied. There should be no long term complication, since the steroid use is one single dose.|1 year||||ml||Standard Deviation|Mean
2677567|NCT01430819|Other Pre-specified|Geometric Mean of Titer Ratios (GMTR) of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.|"Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.~Geometric mean of titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer ratios."|Day 21 post-vaccination|Geometric mean of titer ratios of antibodies against Influenza vaccine antigens were determined in all enrolled and vaccinated participants, per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
2677568|NCT01430819|Other Pre-specified|Number of Participants With Seroconversion Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine|"Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.~Seroconversion was defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40; or a pre-vaccination titer ≥ 1:10 and a four-fold increase in post-vaccination titer."|Day 21 post-vaccination|Seroconversion to Influenza vaccine antigens were determined in all enrolled and vaccinated participants, per-protocol population|||Participants|||Number
2677569|NCT01430819|Other Pre-specified|Geometric Mean Titers of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine.|Anti-influenza antibodies were measured using a hemagglutination inhibition (HAI) assay.|Day 21 post-vaccination|GMTs of antibodies against Influenza vaccine antigens were determined in all enrolled and vaccinated participants, per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
2677570|NCT01430819|Primary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine|"Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.~Grade 3 solicited reactions were defined as: Fever ≥ 39.0°C; Pain, Headache, Malaise and Myalgia, significant, prevents daily activities; Erythema and Swelling > 100 mm."|Day 0 to up to Day 28 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, Intent-to-treat population (Safety Analysis Set).|||Participants|||Number
2677571|NCT01430754|Secondary|Change From Run-In in Circadian Time to Relapse During the Randomized Phase|Time to relapse is defined as a 45 minute or greater decrement in the weekly average of subjective nighttime total sleep time (nTST) compared to the Run-in Phase.|Approximately 8 weeks||||days||95% Confidence Interval|Median
2677572|NCT01430754|Secondary|Change From Run-In in Midpoint of Sleep (MoST) During the Randomized Phase|Midpoint of Sleep Timing (MoST) is the measurement of the average timing of sleep relative to bedtime. The average MoST value will trend to 0 as an individual's sleep becomes more fragmented. Improvement is defined as an increase in the average.|Approximately 12 weeks||||minutes||Standard Error|Mean
2677573|NCT01430754|Secondary|Change From Run-In in Total Daytime Sleep Duration in Lower Quartile of Days (UQ-dTSD) During the Randomized Phase|UQ-dTSD measures the average daytime sleep during the patient's worst 25% of days (longest total daytime sleep) from run-in and randomized phase. Lower number indicates improvement.|Approximately 12 weeks||||minutes||Standard Error|Mean
2680013|NCT01405794|Primary|Change In Urea Nitrogen Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 days||||mg/dL||Standard Deviation|Mean
2677577|NCT01430741|Post-Hoc|Estimated Proportion of Veterans Without Negative Housing Exits|We obtained information on negative housing exits from the HUD-VASH Exit form, which is available in HOMES and tracks the dates and reasons for all exits from the program. We measured whether and when a Veteran experienced a negative housing over the period from study enrollment (i.e. the first date of MISSION-Vet for those served by case managers in the GTO group and the date of the first MISSION-Vet session provided to any Veteran at the appropriate study site for this in the comparison group) until the end of the study observation period; the maximum follow-up time was 2.4 years, but only for HUD-VASH Exits. A negative exit was defined as an exit from HUD-VASH that occurred due to non-compliance with case management, eviction, Veteran dissatisfaction with housing, inability to locate Veteran and incarceration. Kaplan-Meier survival curves to calculate an estimate of the proportion of Veterans in each arm/group not experiencing a negative exit from housing at the study's endpoint.|12 months|All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).|||Proportion of Veterans||95% Confidence Interval|Number
2677578|NCT01430741|Post-Hoc|Predicted Values of Veteran Emergency Department Visits for Medical and Mental Health Concerns|Number of emergency department visits for medical and for mental health. Assessed on a monthly basis for 12 months following study enrollment. These measures were obtained from the standardized monthly and quarterly status reports completed by case managers, which were extracted from HOMES. A dichotomous measure of whether a veteran experienced an emergency department visit for medical or mental health conditions , and not a count of number of emergency department visits. We used a mixed-effects logistic regression model to calculate a predicted values (i.e. a Least-Squares Mean) for each group/arm at the study's end-point holding all variables in the model (Veteran age, Veteran sex, presence of an SMI diagnosis, employment) constant at their mean value. Predicted value reported in log-odds (logit) units.|12 months|All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).|||Log Odd Units of Emergency Dept. Visits||Standard Error|Least Squares Mean
2677579|NCT01430741|Post-Hoc|Predicted Values of Veteran Inpatient Hospitalizations for Medical and Mental Health Conditions|Number of inpatient hospitalization for medical and mental health conditions. Assessed on a monthly basis for 12 months following study enrollment. These measures were obtained from the standardized monthly and quarterly status reports completed by case managers, which were extracted from HOMES. A dichotomous measure of whether a veteran experienced an inpatient hospitalization for medical or mental health conditions , and not a count of number of hospitalizations. Specifically, we used a mixed-effects logistic regression model to calculate a predicted values (i.e. a Least-Squares Mean) for each group/arm at the study's end-point holding all variables in the model (Veteran age, Veteran sex, presence of an SMI diagnosis, employment) constant at their mean value. Predicted value reported in log-odds (logit) units.|12 months|All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).|||Inpatient Hospitalization Log Odds Units||Standard Error|Least Squares Mean
2677580|NCT01430741|Post-Hoc|Drug and Alcohol Dependence|Examined monthly alcohol and drug use by Veterans. Assessed on a monthly basis for 12 months following study enrollment. These measures were obtained from the standardized monthly and quarterly status reports completed by case managers, which were extracted from HOMES.|12 months|All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).|||Monthly Substance Use||Standard Error|Least Squares Mean
2677581|NCT01430741|Post-Hoc|Number of Services Provided by Case Managers and Peers to Veterans|Services provided by Case Managers OR Peers was computed by a count of the number of contacts between case managers OR peers and Veterans. This computed a total of all Veteran contacts, which was the sum of face-to-face contacts with Veterans and contacts on behalf of Veterans (described as Veteran contacts) with other stakeholders (e.g. family, medical providers). Assessed on a monthly basis for 12 months following study enrollment. These measures were obtained from the standardized monthly and quarterly status reports completed by case managers, which were extracted from HOMES. We used a linear-mixed effects model to calculate a Least-Squares Mean for each group at the study's end-point holding all variables in the model (Veteran age, Veteran sex, presence of an SMI diagnosis, employment) constant at their mean value.|12 months|All MISSION-Vet IU Veterans and GTO Veterans were analyzed from HUD-VASH data monitoring system HOMES (Homeless Operations, Management and Evaluation).|||Number of Service Contacts||Standard Error|Least Squares Mean
2677582|NCT01430741|Primary|MISSION Fidelity Index|The fidelity index assesses the presence or absences of activities within MISSION-Vet - DRT, peer led sessions, self-guided exercises, referrals made, and/or delivery of the workbook, to each participating Veteran. We analyzed fidelity as the percent of adoption of MISSION-Vet. The threshold for fidelity to adopt MISSION-Vet is 1 contact between the case manager and each participating Veteran. There is no composite score, fidelity to MISSION-Vet is if the case manager conducted at least 1 session with a Veteran.This measure was embedded into the VA Electronic Medical Record System. The investigators will assess the impact GTO has in facilitating adoption and use with fidelity to the MISSION-Vet 12-month service delivery platform, in comparison to implementation as usual.|12-months|Clinician fidelity to MISSION-Vet using IU or GTO. Only assessed Staff population.|||percentage of MISSION-Vet staff use|||Number
2677583|NCT01430624|Secondary|PTSD Symptom Scale Self-Report (PSS-SR)|Total scores range from 0 to 51 with higher scores indicating greater frequency of symptoms, Measure of PTSD symptoms.|2 weeks prior to 6 week, 3 month, 6 month followup|Only includes those with complete scale score information|||units on a scale||Standard Deviation|Mean
2677584|NCT01430624|Secondary|Non-medical Use of Prescription Drugs Frequency|Number of days of use within the 14 days prior to follow-up assessment|14 days prior to 6 week, 3 month, 6 month follow-up|2 participants had missing data at 6 month follow-up|||days of use||Standard Deviation|Mean
2677585|NCT01430624|Primary|Marijuana Use Frequency|Number of days of use within the 14 days prior to follow-up assessment|14 days prior to 6 week, 3 month, 6 month follow-up||||days of use||Standard Deviation|Mean
2677586|NCT01430624|Primary|Amount of Alcohol Use|estimated number of drinks during the 14 days prior to each follow-up assessment|14 days prior to 6 week, 3 month, 6 month follow-up|1 participant with missing data at 6 week follow-up|||Drinks||Standard Deviation|Mean
2677587|NCT01430624|Secondary|Any Other Illicit Drug Use|Any reported use of cocaine or other illicit drugs other than marijuana in the 14 days prior to follow-up|14 days prior to 6 week, 3 month, 6 month follow-up||||participants|||Number
2677591|NCT01430611|Secondary|Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection site: Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥30 mm. Grade 3 systemic reactions: Fever, temperature >39˚C; Headache, Malaise, and Myalgia, Significant, preventing daily activity.|Day 0 up to Day 7 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set (SafAS). A Group 2 subject received the wrong vaccine and was included in Full Analysis Set for Group 2 (where classification was per vaccine randomized to) and also Group 1 SafAS (where classification was according to vaccine actually received).|||Participants|||Number
2677592|NCT01430611|Secondary|Geometric Mean Titers of Serogroup C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean titers were assessed in the Per-protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2677593|NCT01430611|Secondary|Geometric Mean Titers of Serogroup A Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean titers were assessed in the Per-protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2677594|NCT01430611|Secondary|Geometric Mean Titers of Serogroup A and C Antibodies Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group A and C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 0 (pre-vaccination) and Day 30 post-vaccination|Geometric mean titers were assessed in the Full Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2677595|NCT01430611|Secondary|Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup C Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group C antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR)..|Day 0 (pre-vaccination) and Day 30 post-vaccination|Immunogenicity was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2677596|NCT01430611|Secondary|Percentage of Participants With Post-vaccination Titer ≥1:8 for Serogroup A Before and Following Vaccination of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Meningococcal Group A antibodies were measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR)..|Day 0 (pre-vaccination) and Day 30 post-vaccination|Immunogenicity was assessed in the Per Protocol Analysis Set.|||Percentage of participants|||Number
2677597|NCT01430611|Primary|Number of Participants With Seroconversion Following Vaccination With Either Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine or Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine|Seroconversion status was defined as antibody titers against meningococcal serogroups A and C, 30 days after vaccine administration ≥ 4-fold increase from pre-vaccination level measured by 2,3,5 triphenyltetrazolium chloride (TTC) serum bactericidal assay using baby rabbit complement (SBA-BR).|Day 30 post-vaccination|Seroconversion was assessed in the Per-protocol Analysis Set.|||Participants|||Number
2677598|NCT01430585|Secondary|Number of Participants With Genetic Alterations: Phase 2|Following genetic alterations were planned to be analyzed: mutations in Phosphoinositide 3-kinase, catalytic, alpha (PIK3CA), amplification of PIK3CA, Phosphate and tensin homolog (PTEN) deficiency, and changes in other genes or proteins in, or impacting V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS), Insulin-like Growth Factor 1 Receptor (IGF-1R), phosphatidylinositol 3-kinase (PI3K)/ mammalian target of rapamycin (mTOR) pathway.|Phase 2: Baseline, Week 2, 6|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.||||||
2677599|NCT01430585|Secondary|Change From Baseline in Pharmacodynamic, Cell Proliferation and Survival Biomarkers in Biopsied Tumor Tissue at Week 2 and 6: Phase 2|Change from baseline in following pharmacodynamic parameters were planned to be calculated: expression and/or phosphorylation of Phosphoinositide-3-kinase (PI3K) pathway proteins in biopsied tumor tissue and markers of cell cycle and survival.|Phase 2: Baseline, Week 2, 6|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.||||||
2677600|NCT01430585|Secondary|Pharmacokinetic (PK) Parameters of PF-04691502 and Letrozole: Phase 1B and 2|Phase 1B: Following PK parameters were planned to be calculated from the plasma concentration time data using standard non-compartmental methods. For PF-04691502: area under the curve from time zero to last quantifiable concentration (AUClast), area under the curve from time zero to end of dosing interval (AUCtau), maximum observed plasma concentration (Cmax), minimum observed plasma trough concentration (Cmin), average plasma concentration (Cavg), time to reach maximum observed plasma concentration (Tmax), observed accumulation ratio (Rac [obs]); for letrozole: AUClast, Cmax. Phase 2: Following PK parameters were planned to be calculated for PF-04691502 from the plasma concentration time data using standard non-compartmental methods- AUClast, Cmax and Tmax.|Phase 1B: 0 (pre-dose), 1, 2, 4, 6, 24 hours on Day 1 (letrozole alone), Day 2 (PF-0491502 alone), Day 12, Week 5 (PF-0491502 and letrozole in combination); Phase 2: 0 (pre-dose), 1, 2, 4, 6, 24 hours on Day 1, pre-dose on Week 2, 6|Data for phase 1B was reported in individual participant listings but not statistically summarized for analysis due to premature termination of the study. No participant was enrolled in phase 2 of the study.||||||
2677616|NCT01430403|Secondary|Work Disruptions Due to Child's Asthma, Treatment Steps 2-4: Omalizumab vs. ICS|The ratio of the work hours missed due to child's asthma over the numbers of work hours in the past 14 days among caretakers working|90 Day outcome period|Intent-to-treat with available data|||Ratio||Standard Error|Mean
2677601|NCT01430585|Secondary|Number of Participants With Objective Response (OR): Phase 1B and 2|Number of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target lesions, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No appearance of new lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (>=) 30 percent (%) decrease from baseline of the sum of diameters of all target lesions, using the short diameter in the sum for target nodes and the longest diameter in the sum for all other target lesions.|Phase 1B: Baseline, Week 12, end of treatment (Week 34); Phase 2: Baseline, Week 6, 16 or ET|Data for phase 1B was reported in individual participant listings but not statistically summarized for analysis due to premature termination of the study. No participant was enrolled in phase 2 of the study.||||||
2677602|NCT01430585|Secondary|Number of Participants With Clinically Significant Abnormalities in Corrected QT (QTc) Interval: Phase 1B||Phase 1B: Baseline up to end of treatment (Week 34)|Data was not analyzed due to premature termination of the study.||||||
2677603|NCT01430585|Secondary|Number of Participants With Clinically Significant Abnormalities in Vital Signs: Phase 1B and 2|Vital signs assessments planned to include measurement of blood pressure and heart rate.|Phase 1B: Baseline up to 28 days after last dose of study treatment (Week 34); Phase 2: Baseline up to Week 16 or ET|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.||||||
2677604|NCT01430585|Secondary|Number of Participants With Clinically Significant Laboratory Tests Abnormalities: Phase 1B and 2|Laboratory analysis planned to include blood chemistry, hematology and urinalysis.|Phase 1B: Baseline up to end of treatment (Week 34); Phase 2: Baseline up to Week 16 or early termination (ET)|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.||||||
2677605|NCT01430585|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Phase 2|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Phase 2: Baseline up to 28 days after last administration of study treatment|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.||||||
2677606|NCT01430585|Primary|Change From Baseline in Ki-67 Percent Positive Tumor Cells in Biopsied Tumor Tissue at Week 6: Phase 2|Nuclear proliferation marker Ki-67 was to be assessed by immunohistochemistry technique in all specimens.|Phase 2: Baseline, Week 6|Data was not analyzed due to premature termination of the study. No participant was enrolled in phase 2 of the study.||||||
2677607|NCT01430585|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Phase 1B|An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Phase 1B: Baseline up to 28 days after last administration of study treatment|Safety analysis set included all enrolled participants who started study treatment.|||participants|||Number
2677608|NCT01430468|Secondary|Intra-operative Photographs|We will use the intra-operative photographs to qualitatively document the surgical steps. These photos may be useful to explain a deviation in the surgery than what would have been expected by the pre-operative simulator.|Post Op CT within 1 year from surgery|||||||
2677609|NCT01430468|Primary|Comparing Glenoid Component Positioning to Pre Operative Planning|Final implant position will be determined by comparing the position of the glenoid component on the post-operative CT scans with the implant position planned pre-operatively on the surgical simulator. These measurements will be in millimeters and degrees.|1 month post op||||Degrees||Standard Deviation|Mean
2677610|NCT01430455|Primary|29 Item Hamilton Rating Scale for Depression (HamD29)|29 Item Hamilton Rating Scale for Depression (HamD29) is the 29 item version of the most common depression rating scale. The scores represented here are the average scores at baseline and after 16 weeks of open label treatment. The scale is rated from 0-89 with higher scores representing a more depressed state.|Hamilton 29 score at baseline (start date of medication) and week 16|2 patients who did not make it to week 16 (one dropped out at week 3 and one dropped out at week 9)|||Hamilton Depression score||Standard Error|Mean
2677611|NCT01430403|Secondary|Comparison of Home Allergen (Cockroach) Exposure and Asthma Exacerbations: Omalizumab Versus Placebo|Residential environmental exposure to cockroach allergen of participants in the context of the risk of asthma exacerbations and effect of omalizumab versus placebo (control) on asthma exacerbations was explored. Presence of cockroach allergen in household dust samples was assessed. Exacerbation defined as: participant required either 1.)a prescribed course of systemic steroids by a clinician2.)initiation of a course of systemic steroids or 3.)a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. In cases that a participant initiated and completed a course of systemic steroids without clinician involvement, the course was counted as an exacerbation only with fulfillment of the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥10mg per day for ≥1 day).|90 Day outcome period|"Prespecified Outcome Measure: analysis limited to the Omalizumab and Placebo Groups.~Analysis: intent-to-treat (with available data)."|||Participants|||Count of Participants
2677612|NCT01430403|Secondary|Percent Adherence to Asthma Medication, Treatment Steps 2-4: Omalizumab vs. ICS|Adherence to the study regimen and other asthma treatments, assessed as percent of expected dose taken, by means of study interviews and study physician corroboration.|90 Day outcome period|Intent-to-treat|||percent adherence||Standard Error|Mean
2677617|NCT01430403|Secondary|Work Disruptions Due to Child's Asthma, Treatment Steps 2-5: Omalizumab vs. Placebo|The ratio of the work hours missed due to child's asthma over the numbers of work hours in the past 14 days among caretakers working.|90 Day outcome period|Intent–to-treat with available data|||Ratio||Standard Error|Mean
2677618|NCT01430403|Secondary|Asthma Control Test Score: Child Asthma Control Test (C-ACT), Treatment Steps 2-4: Omalizumab vs. ICS|The Childhood Asthma Control Test (C-ACT) is a validated tool to assess overall asthma control (over the last 4 weeks) in patients ages 4 to 11 years. Scores can range from 0 to 27. A score of 19 or less is indicative of asthma that is not well controlled. The minimally important difference in C-ACT scores is not defined.|90 Day outcome period|Intent-to-treat with available C-ACT Scores|||C-ACT Score||Standard Error|Mean
2677619|NCT01430403|Secondary|Asthma Control Test Score: Child Asthma Control Test (C-ACT), Treatment Steps 2-5: Omalizumab vs. Placebo|The Childhood Asthma Control Test (C-ACT) is a validated tool to assess overall asthma control (over the last 4 weeks) in patients ages 4 to 11 years. Scores can range from 0 to 27. A score of 19 or less is indicative of asthma that is not well controlled. The minimally important difference in C-ACT scores is not defined|90 Day outcome period|Intent–to-treat with available C-ACT Scores|||C-ACT Score||Standard Error|Mean
2677620|NCT01430403|Secondary|Asthma Control Test Scores: Asthma Control Test (ACT), Treatment Steps 2-4: Omalizumab vs. ICS|The Asthma Control Test (ACT) is a validated tool to assess asthma control (over the last 4 weeks) in patients ≥12 yrs old. It is comprised of 5 questions assessing symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale (higher score indicating better control). Total scores can range from 5-25. A score of ≤19 is indicative of not well-controlled asthma. The minimally important difference is 3 points.|90 Day outcome period|Intent-to-treat with available ACT Scores|||ACT Score||Standard Error|Mean
2677621|NCT01430403|Secondary|Asthma Control Test Scores: Asthma Control Test (ACT), Treatment Steps 2-5: Omalizumab vs. Placebo|Outcome measure description: The Asthma Control Test (ACT) is a validated tool to assess asthma control (over the last 4 weeks) in patients ≥12 yrs old. It is comprised of 5 questions assessing symptoms, use of rescue medications, and the impact of asthma on everyday functioning. All questions are scored on a 5-point Likert scale (higher score indicating better control). Total scores can range from 5-25. A score of ≤19 is indicative of not well-controlled asthma. The minimally important difference is 3 points.|90 Day outcome period|Intent–to-treat with available ACT scores|||ACT Score||Standard Error|Mean
2677622|NCT01430403|Secondary|Spirometry Measurements: FEV1:FVCx100, Treatment Steps 2-4: Omalizumab vs. ICS|The FEV1 (forced expiratory volume 1))/ FVC (forced vital capacity) ratio is used to evaluate airways obstructions since pure restrictive ventilatory defects cause an equal reduction in the FEV1 and the FVC. An FEV1/FVC ratio below 80% indicates airflow obstruction. Normal FEV1/FVC: 8 - 19 years of age=85%.|90 Day outcome period|Intent-to-treat|||percent FEV1/FVC ratio||Standard Error|Mean
2677623|NCT01430403|Secondary|Spirometry Measurements: FEV1:FVCx100, Treatment Steps 2-5: Omalizumab vs. Placebo|The FEV1 (forced expiratory volume 1))/ FVC (forced vital capacity) ratio is used to evaluate airways obstructions since pure restrictive ventilatory defects cause an equal reduction in the FEV1 and the FVC. An FEV1/FVC ratio below 80% indicates airflow obstruction. Normal FEV1/FVC: 8 - 19 years of age=85%.|90 Day outcome period|Intent–to-treat|||percent FEV1/FVC ratio||Standard Error|Mean
2677624|NCT01430403|Secondary|Spirometry Measurements: Forced Expiratory Volume in 1 Second (FEV1) % Predicted , Treatment Steps 2-4: Omalizumab vs. ICS|FEV1 is air volume exhaled in 1 second during spirometry. Asthma severity classification for trial: mild--pre-bronchodilator FEV1 ≥ 80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; moderate--pre-bronchodilator FEV1 <80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; severe--requiring high-dose inhaled glucocorticoids with/without continuous/near continuous oral glucocorticoids, or uncontrolled despite treatment. FEV1 percent of predicted value is FEV1 converted to a percentage of normal, based on height, weight, and race.|90 Day outcome period|Intent-to-treat|||percent predicted FEV1||Standard Error|Mean
2677625|NCT01430403|Secondary|Spirometry Measurements: Forced Expiratory Volume in 1 Second (FEV1) % Predicted, Treatment Steps 2-5:Omalizumab vs. Placebo|FEV1 is air volume exhaled in 1 second during spirometry. Asthma severity classification for trial: mild--pre-bronchodilator FEV1 ≥ 80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; moderate--pre-bronchodilator FEV1 <80% predicted requiring no/ low-moderate dose of inhaled glucocorticoids; severe--requiring high-dose inhaled glucocorticoids with/without continuous/near continuous oral glucocorticoids, or uncontrolled despite treatment. FEV1 percent of predicted value is FEV1 converted to a percentage of normal, based on height, weight, and race.|90 Day outcome period|Intent–to-treat|||percent predicted FEV1||Standard Error|Mean
2677626|NCT01430403|Secondary|Composite Asthma Severity Index (CASI), Treatment Steps 2-4: Omalizumab vs. ICS|CASI scores include 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. To calculate CASI, the 5 domain scores are summed to determine a final score, which can range from 0 to 20, with 0 being no severity of asthma and 20 being extremely severe asthma.|90 Day outcome period|Intent-to-treat with available CASI scores|||CASI Score||Standard Error|Mean
2677627|NCT01430403|Secondary|Composite Asthma Severity Index (CASI), Treatment Steps 2-5: Omalizumab vs. Placebo|CASI scores include 5 domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. To calculate CASI, the 5 domain scores are summed to determine a final score, which can range from 0 to 20, with 0 being no severity of asthma and 20 being extremely severe asthma.|90 Day outcome period|Intent–to-treat|||CASI Score||Standard Error|Mean
2677639|NCT01430169|Primary|AUX-I Tmax After Injection 2|Time to maximum AUX-I enzyme concentration. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|"Pharmacokinetic (PK) population (N=19). In addition, 2 subjects have been excluded from the analysis due to ELISA interference.~Of the 38 AUX-I profiles, 7 had no quantifiable plasma concentrations through 24 hours post injection."|||hour||Standard Deviation|Mean
2677929|NCT01426438|Secondary|Change in Small LDL Particles|Change in Small LDL particles from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||nmol/L||Inter-Quartile Range|Median
2677628|NCT01430403|Secondary|Number of Exacerbations Evaluated Monthly With Viral Respiratory Infections: Omalizumab vs. Placebo|Asthma exacerbation is defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥10mg per day for ≥1 day. The hypothesis behind this outcome measure is that omalizumab will change virology; thus, the intent of this measure was to assess the comparator group of placebo against omalizumab.|90 Day outcome period|"The pre-specified intent for Outcome Measure: analysis inclusion limited to the Omalizumab and Placebo Groups.~Analysis: intent-to-treat (with available data)."|||Total Number of Viral Infections||Standard Error|Mean
2677629|NCT01430403|Secondary|Severity of Asthma Symptoms Associated With a Viral Infection:Omalizumab vs. Placebo|Severity asthma symptoms is defined as the highest value among the following 3 variables: number of days with wheezing, tightness in the chest, or cough; number of nights with disturbed sleep as a result of asthma; and number of days on which a participant had to slow down or discontinue play/physical activities over a two week period associated with a viral infection. This outcome looks at the effect by group on number of days with asthma symptoms and infections. The hypothesis behind this outcome measure is that omalizumab will change virology; thus, the the intent of this measure was to assess the comparator group of placebo against omalizumab|90 Day outcome period|"The pre-specified intent for Outcome Measure: analysis inclusion limited to the Omalizumab and Placebo Groups.~Analysis: intent-to-treat (with available data)."|||Maximum Symptoms Days||Standard Error|Mean
2677630|NCT01430403|Secondary|Virus-induced Exacerbations as Measured by an Exacerbation That is Associated With a Virus Detected Using the Nasal Mucus Samples|Asthma exacerbation:defined by a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the 1st day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥ 20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥ 10mg per day for ≥1 day. Exacerbations were then associated with viral respiratory infections based on nasal mucus samples collected monthly. Nasal mucus samples were categorized as having exacerbations or not having exacerbations. Participants could potentially be counted in each group, as participants could have samples with exacerbations and samples without exacerbations.|90 Day outcome period|Nasal mucus samples|||Percent Samples with virus|Number of Samples Analyzed||Number
2677631|NCT01430403|Primary|Occurrence of One or More Asthma Exacerbations (Treatment Steps 2-4)|Asthma exacerbation defined as a prescription of a course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥10mg per day for ≥1 day. Odds ratio comparing Inhaled corticosteroid boost therapy (ICS) and Omalizumab arms at Treatment Steps 2-4.|90 Day outcome period|Intent-to-treat|||Percent of adjusted prevalence|||Number
2677632|NCT01430403|Primary|Occurrence of One or More Asthma Exacerbations (All Treatment Steps [Steps 2-5])|Asthma exacerbation defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at ≥ 20mg per day for 3 of any 5 consecutive days; or dexamethasone at ≥10mg per day for ≥1 day. Odds ratio comparing Placebo and Omalizumab arms across all treatment steps (Steps 2-5).|90 Day outcome period|Intent–to-treat|||Percent of adjusted prevalence|||Number
2677633|NCT01430325|Primary|Participant Perception of Breathing Gas|Percent of participants in each arm guessing that their breathing gas was 100% oxygen.|Within 15 minutes of chamber excursion|40 of 42 participants provided an answer to this question.|||percentage of participants|||Number
2677634|NCT01430325|Primary|Participant Perception of Depth|Mean depth perception for participants providing a free response.|Within 15 minutes of chamber excursion|"23 of 42 participants provided a numerical response. The remainder selected I do not know."|||fsw||Standard Deviation|Mean
2677635|NCT01430325|Primary|"Participants Indicating I do Not Know on Depth Questionnaire."|"Participants indicating I do not know on depth questionnaire instead of providing a free response guess."|Within 15 minutes of chamber excursion|All participants who enrolled in the study were analyzed.|||participants|||Number
2677636|NCT01430299|Primary|Number of Radiographic Assessments That Indicate Posterolateral Fusion at 12 Months Post Surgery|Posterolateral fusion by radiographic assessment 12 months post surgery|12 months|One to 3 spinal levels between L3 and S1 were treated per patient. Fusion was assessed twice per treated level. There were 23 OsteoSurge 300 levels and 37 rhBMP-2 levels but 46 OsteoSurge assessments and 74 rhBMP-2 assessments.|||radiographic assessments|radiographic assessments||Count of Units
2677637|NCT01430182|Primary|Opioid Consumption|Number of morphine equivalents used by subject during first 24 hours after discharge from Post-Anesthesia Care Unit|First 24 hours after discharge from Post-Anesthesia Care Unit||||mg of morphine IV equivalents||Standard Deviation|Mean
2677638|NCT01430169|Primary|AUX-II Tmax After Injection 2|Time to maximum AUX-II enzyme concentration. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19) In addition, 2 subjects have been excluded from the analysis due to ELISA interference. Of the 38 AUX-II profiles,23 had no quantifiable plasma concentrations at any time point through 24 hours post injection.|||hours||Standard Deviation|Mean
2677640|NCT01430169|Primary|AUX-II AUC0-tlast After Injection 2|Area under the curve from zero to tlast within 24 hours after the Injection 2, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-II. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19)|||ng*h/mL||Standard Deviation|Mean
2677641|NCT01430169|Primary|AUX-I AUC0-tlast After Injection 2|Area under the curve from zero to tlast within 24 hours after the Injection 2, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-I. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)|||ng*h/mL||Standard Deviation|Mean
2677642|NCT01430169|Primary|AUX-II Cmax After Injection 2|Maximum AUX-II enzyme concentration from zero to 24 hours after Injection 2. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19)|||ng/mL||Standard Deviation|Mean
2677643|NCT01430169|Primary|AUX-I Cmax After Injection 2|Maximum AUX-I enzyme concentration from zero to 24 hours after Injection 2.AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 2 (24 hours after Injection 1 or 0 hour for Injection 2); 5, 10, 20, and 30 minutes after Injection 2; 1, 2, 4, 8, and 12 hours after Injection 2; Day 3 (24 hours after Injection 2)|Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)|||ng/mL||Standard Deviation|Mean
2677644|NCT01430169|Primary|AUX-II Tmax After Injection 1|Time to maximum AUX-II enzyme concentration. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19) One subject was excluded from AUX-II PK analyses due to insufficient quantities of plasma for bioanalysis. Of the 38 AUX-II profiles, 23 had no quantifiable plasma concentrations at any time point through 24 hours post injection.|||hours||Standard Deviation|Mean
2677645|NCT01430169|Primary|AUX-I Tmax After Injection 1|Time to maximum AUX-I enzyme concentration. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19). For 3 subjects Tmax was considered missing if concentration was BLQ for all time points at that injection and 2 subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)|||hours||Standard Deviation|Mean
2677646|NCT01430169|Primary|AUX-II AUC0-tlast After Injection 1|Area under the curve from pre-injection to tlast within 24 hours after the Injection 1, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-II. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19)|||ng*h/mL||Standard Deviation|Mean
2677647|NCT01430169|Primary|AUX-I AUC0-tlast After Injection 1|Area under the curve from pre-injection to tlast within 24 hours after the Injection 1, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-I. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)|||ng*h/mL||Standard Deviation|Mean
2677648|NCT01430169|Primary|AUX-II Cmax After Injection 1|Maximum AUX-II (clostridium Type II collagenase) enzyme concentration from pre-injection to 24 hours after Injection 1. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19).|||ng/mL||Standard Deviation|Mean
2677649|NCT01430169|Primary|AUX-I Cmax After Injection 1|Maximum AUX-I (clostridial type I collagenase) enzyme concentration from pre-injection to 24 hours after Injection 1. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).|15 minutes before Injection 1 (0 hour for Injection 1); 5, 10, 20, and 30 minutes after Injection 1; 1, 2, 4, 8, and 12 hours after Injection 1; 15 minutes before Injection 2 (24 hours after Injection 1)|Pharmacokinetic (PK) population (N=19). Two subjects were excluded from the analysis due to bioanalytical reasons (ELISA interference)|||ng/mL||Standard Deviation|Mean
2677650|NCT01430130|Secondary|Comparison of Scar Smoothness of Treated Side as Compared to the Control Side||Up to 12 months|||||||
2677651|NCT01430130|Secondary|Comfort Level Related to Study Device Application, Wear and Removal||Up to 12 weeks|||||||
2677652|NCT01430130|Secondary|Ease of Use||Up to 12 months|||||||
2677653|NCT01430130|Secondary|Subject and Investigator Satisfaction With the Aesthetic Results||Up to 12 months|||||||
2677666|NCT01430091|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to the Last Measureable Concentration (AUC[0-tlast]) of Prasugrel's Active Metabolite (PRAS-AM)||Pre-dose up to 8 hours post-dose after each treatment|Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel.|||nanogram * hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2677654|NCT01430130|Primary|Visual Analogue Scale (VAS)|"Visual Analogue Scale Scar Score (VAS Scar Score) was defined and validated by Duncan et al 2006[1]. This scale consists of a 10cm line representing scar quality, with 0 representing normal skin and 10 indicating a poor scar. The assessor places a mark along the line to represent the appearance of the scar. This mark is translated into a score by measuring its position on the 10cm line to one decimal place. The independent panel used this to scale the primary outcome.~[1] Duncan J, Bond J, Mason T, Ludlow A, Cridland P, O'Kane S and Ferguson M. Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality? Plast. Reconstr. Surg. 118: 909, 2006."|6 months|Per protocol, all eligible patients who did not exit the study prematurely.|||Units on a scale||Standard Error|Mean
2677655|NCT01430104|Secondary|Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3||Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum 1,25-Hydroxy-Vitamin D3 assessment were included in the analysis.|||picogram per milliliter (pg/mL)||Standard Deviation|Mean
2677656|NCT01430104|Secondary|Concentrations of Serum 25-Hydroxy-Vitamin D||Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum 25-Hydroxy-Vitamin D assessment were included in the analysis.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2677657|NCT01430104|Secondary|Change From Baseline in Daily Urine Calcium Excreted||Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide, had a baseline urine calcium assessment, and at least 1 postdose urine calcium assessment were included in the analysis.|||grams per day (g/day)||Standard Deviation|Mean
2677658|NCT01430104|Secondary|Mean Daily Urine Calcium Excreted||Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose urine calcium assessment were included in the analysis.|||grams per day (g/day)||Standard Deviation|Mean
2677659|NCT01430104|Secondary|Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline|Urine calcium levels presented are for any day during the 28-day Teriparatide Treatment Period.|Day 1 up to Day 28 (28-day Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose urine calcium assessment were included in the analysis.|||participants|||Number
2677660|NCT01430104|Secondary|Change From Baseline in Serum Calcium|Corrected calcium (milligram per deciliter [mg/dL]) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter [g/dL]). The Least Squares (LS) means were controlled for Day, Timepoint, Day*Timepoint, and random error. Postdose refers to after Teriparatide dose.|Baseline (Day -1 of the 14-day Lead-in Period), Day 1, Day 7, Day 14, Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period)|All enrolled participants who complied received at least 1 dose of Teriparatide, completed all protocol requirements, and had at least 1 postdose serum calcium assessment were included in the analysis.|||mg/dL||90% Confidence Interval|Least Squares Mean
2677661|NCT01430104|Secondary|Mean Serum Calcium Levels|Daily profiles of corrected mean serum calcium levels were determined for each participant. Corrected calcium (milligram per deciliter [mg/dL]) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter [g/dL]). The Least Squares (LS) means were adjusted for Day, Timepoint, Day*Timepoint, and random error. At baseline, participants received only Aspara-CA and Alfarol supplements and the timepoints were based on the times before Aspara-CA and Alfarol administration (predose) and after Aspara-CA and Alfarol administration (postdose). During the 28-day Teriparatide Treatment Period, timepoints were based on before Teriparatide administration (predose) and after Teriparatide administration (postdose).|Baseline (Day -1 of 14-day Lead-in Period) and Day 1 and Day 7 and Day 14 and Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide, completed all protocol requirements, and had at least 1 postdose serum calcium assessment were included in the analysis.|||mg/dL||90% Confidence Interval|Least Squares Mean
2677662|NCT01430104|Secondary|Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) and 13.5 mg/dL, Respectively at Any Time Postbaseline|Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter [g/dL]). Serum calcium levels presented are for any time postdose on any day during the 28-day Teriparatide Treatment Period.|Day 1 up to Day 28 (Teriparatide Treatment Period)|All enrolled participants who received at least 1 dose of Teriparatide and had at least 1 postdose serum calcium assessment were included in the analysis.|||participants|||Number
2677663|NCT01430104|Primary|Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL)|Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter [g/dL]). Postdose refers to after Teriparatide dose.|Day 28 (16 and 24 hours postdose)|All enrolled participants who received at least 1 dose of Teriparatide and had either a 16-hour or 24-hour postdose serum calcium assessment on Day 28 were included in the analysis.|||participants|||Number
2677664|NCT01430091|Primary|Pharmacokinetics: Time of Maximum Concentration (Tmax) of Prasugrel's Active Metabolite (PRAS-AM)||Pre-dose up to 8 hours post-dose after each treatment|Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel.|||hours||Full Range|Median
2677665|NCT01430091|Primary|Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel's Active Metabolite (PRAS-AM)||Pre-dose up to 8 hours post-dose after each treatment|Pharmacokinetic analyses were conducted on the full analysis set, which included all data from all randomized participants receiving at least 1 dose of prasugrel.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2677695|NCT01429298|Post-Hoc|Number of Participants Who Achieved at Least 50% Decline in NRS Pain Score at 30 Minutes||30 minutes|The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)|||Participants|||Count of Participants
2677667|NCT01429987|Secondary|Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score|The severity of straining (Straining Score) was reported by the patients using a 11-point scale (0-10) where 0 = none and 10 = the worst|12-Week Treatment Period|The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.|||scores on a scale||Standard Error|Least Squares Mean
2677668|NCT01429987|Secondary|Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period|"The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale [BSFS] from 1 to 7.~= separate hard lumps like nuts (difficult to pass)~= sausage shaped but lumpy~= like a sausage but with cracks on its surface~= like a sausage or snake, smooth and soft~= soft blobs with clear-cut edges (passed easily)~= fluffy pieces with ragged edges, a mushy stool~= watery, no solid pieces (entirely liquid)"|12-Week Treatment Period|The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.|||scores on a scale||Standard Error|Least Squares Mean
2677669|NCT01429987|Secondary|Change From Baseline in 12-week SBM Weekly Frequency Rate|The number of Spontaneous Bowl Movements experienced per week.|12-Week Treatment Period|The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.|||SBMs per week||Standard Error|Least Squares Mean
2677670|NCT01429987|Secondary|Change From Baseline in 12-week CSBM Weekly Frequency Rate|The number of Complete Spontaneous Bowel Movements (CSBMs) per week|12-Week Treatment Period|The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.|||CSBMs per week||Standard Error|Least Squares Mean
2677671|NCT01429987|Primary|Overall Responder 9/12 Weeks|A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation. A weekly responder will have 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week. An overall responder is a patient who is a weekly responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks.|12-Week Treatment Period|The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.|||% of Overall Responder 9/12 weeks|||Number
2677672|NCT01429792|Secondary|Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24|The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment.|Week 24|As pre-specified in the protocol, genotypes 1 and 4 were combined due to insufficient enrollment for genotype 4.||||||
2677673|NCT01429792|Secondary|Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment|The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment.|Week 12|As pre-specified in the protocol, genotypes 1 and 4 were combined due to insufficient enrollment for genotype 4.||||||
2677674|NCT01429792|Secondary|Percentage of Participants With pEVR to Study Treatment at Week 12|The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.|Week 12|As pre-specified in the protocol, genotypes 1 and 4 were combined due to insufficient enrollment for genotype 4.||||||
2677675|NCT01429792|Primary|Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24|The rate of participants with non-RVR and undetectable HCV-RNA at Week 24 was defined as detectable HCV-RNA level at Week 4 of study treatment and undetectable HCV-RNA at Week 24 of study.|Week 24|Participants with CHC Genotype 2 & 3 at Week 24|||Percentage of participants||95% Confidence Interval|Number
2677676|NCT01429792|Primary|Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment|The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment.|Week 4|Participants with CHC Genotype 2 & 3 at Week 4|||Percentage of participants||95% Confidence Interval|Number
2677677|NCT01429792|Primary|Percentage of Participants With Rapid Virologic Response (RVR) at Week 4|The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment.|Week 4|Participants with CHC Genotype 2 & 3 at Week 4|||Percentage of participants||95% Confidence Interval|Number
2677678|NCT01429792|Primary|Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24|The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment|Week 24|Participants with CHC Genotype 1 & 4 at Week 24|||Percentage of participants||95% Confidence Interval|Number
2677679|NCT01429792|Primary|Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment|The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment|Week 12|Participants with CHC Genotype 1 & 4 at Week 12|||Percentage of participants||95% Confidence Interval|Number
2677680|NCT01429792|Primary|Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment|The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.|Week 12|Participants with CHC Genotype 1 & 4 at week 12|||Percentage of participants||95% Confidence Interval|Number
2677681|NCT01429623|Secondary|Change in Disability Assessment in Dementia for Ladostigil Versus Placebo Population|Mean value change (from baseline) in Disability Assessment in Dementia (DAD) across entire study period. DAD evaluates the basic and instrumental activities in daily activities of elderly people with dementia. Higher scores reflect better functioning. DAD ranges from 0 to 100.|3,6,12,18,24,30 and 36 months||||Change from basline on units on a scale||Standard Deviation|Mean
2677682|NCT01429623|Secondary|Change in Neuropsychiatric Test Battery for Ladostigil Versus Placebo Population|Mean value change (from baseline) in Neuropsychiatric Test Battery (NTB) across entire study period. The NTB included the following well known cognitive tests: Rey Auditory Verbal Learning Test (RAVLT), Controlled Word Association Test (COWAT), Category Fluency Test (CFT), WMS-R Digit Span, and Trail Making Part A and B. The mean value was comprised of the z score of each of these tests with all z scores in the direction of higher scores better functioning. Range -3 to +3.|3,6,12,18,24,30 and 36 months|Modified Intent to treat (all randomized subject with at least one post baseline assessment)|||Change from basline on units on a scale||Standard Deviation|Mean
2677683|NCT01429623|Secondary|Change in Geriatric Depression Scale for Ladostigil Versus Placebo Population|"Mean value change (from baseline) in Geriatric Depression Scale (GDS) across entire study period. The GDS ranges from 0 to 30. Scores of 0-9 are considered normal, 10-19 mildly depressed, and 20-30 severely depressed."|3,6,12,18,24,30 and 36 months|Modified Intent to Treat|||Change from basline on units on a scale||Standard Deviation|Mean
2677684|NCT01429623|Primary|Conversion From Mild Cognitive Impairment to Alzheimer's Disease Compared to Placebo|"Total number of conversions from Mild Cognitive Impairment to Alzheimer's disease across entire 3 year study period. Conversion is determined, or defined, by a Clinical Dementia Rating (CDR) score of greater than or equal to one.~Composite rating ranges from 0 no symptoms of dementia to 3 Severe symptoms of dementia."|3,6,12,18,24,30 and 36 months|All randomized subjects with at least one post-baseline visit.|||Participants|||Count of Participants
2677685|NCT01429584|Secondary|Satisfaction With Pain Control|A follow-up phone call was made to patients within 30 days of surgery to assess the presence of any complications related to the block and overall satisfaction with pain control. Overall satisfaction was assessed on a 7-point Likert scale of 1-not at all satisfied with pain control 2-mostly unsatisfied with pain control 3-slightly unsatisfied with pain control 4-no opinion 5-slightly satisfied with pain control 6-mostly satisfied with pain control 7-completely satisfied with pain control.|Within 30 days|Same as other outcome measures|||Likert Satisfaction Scale||Standard Deviation|Mean
2677686|NCT01429584|Secondary|Pain Relief|Pain relief was assessed by recording the amount of opioid administered intraoperatively and in the PACU. The Visual Analogue Score of pain scores (0-10, with 0 being no pain and 10 being the worst pain imaginable) were recorded at the time of discharge from the PACU, within 5 hours of the completion of surgery.|At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery|Same as other outcome measures.|||Visual Analogue Scale for pain||Standard Deviation|Mean
2677687|NCT01429584|Primary|Abnormal Lung Function|Lung function was evaluated by examining diaphragm movement using ultrasound imaging and change in room air oxygen saturation (SpO2). Diaphragm movement was assessed using ultrasound as Normal (diaphragm moves caudad with inspiration), Abnormal (diaphragm does not move caudad with inspiration), and Paradoxical (diaphragm moves cephalad with inspiration). Both diaphragm function and room air SpO2 were assessed prior to any intervention to establish a baseline, and again on discharge from the PACU, within 5 hours of the completion of surgery.|At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery|Power analysis was performed and a drop-out rate of 10% was anticipated.|||participants w/ abnormal diaphragm fxn|||Number
2677688|NCT01429532|Primary|Surgically Induced Astigmatism|Corneal astigmatism was measured using an eye scanner (Pentacam; Oculus, Wetzlar, Germany), and the SIA was calculated at each postoperative visit using the following equation.|post-operative week 1, post-operative month 1, and post-operative month 3||||Diopters||Standard Deviation|Mean
2677689|NCT01429532|Secondary|Best-corrected Visual Acuity|The best-corrected visual acuity (BCVA) was measured, using an ETDRS chart and auto-refraction as refined by an ophthalmologist, preoperatively and at postoperative 1 day, 1 week, 1 month and 3 months.|post-operative week 1, post-operative month 1, and post-operative month 3|The SPSS software package (version 17.0, SPSS Inc, Chicago, IL, USA) was used for statistical analysis.|||logMAR||Standard Deviation|Mean
2677690|NCT01429532|Primary|Central Cornea Endothelial Cell Loss|Central cornea endothelial cell loss was calculated on the basis of preoperative and postoperative endothelial cell density.|post-operative week 1, post-operative month 1, and post-operative month 3|The SPSS software package (version 17.0, SPSS Inc, Chicago, IL, USA) was used for statistical analysis and sample size calculation. Mean ultrasound time (UST), surgical time, cumulative dissipated energy (CDE), total BSS volume, and SIA were compared using multifactor analysis of variance.|||% of endothelial cell loss||Standard Deviation|Mean
2677691|NCT01429441|Secondary|Proportion of Subjects With a ≥2 Lines Improvement in Best-corrected Visual Acuity (BCVA) From Baseline at Month 24|≥2 lines improvement in BCVA from baseline, irrespective of vitrectomy. Missing data were imputed using the LOCF method.|Month 24|FAS. 1 subject did not have BCVA results at baseline and was excluded from this analysis.|||Percentage (weighted across strata)||95% Confidence Interval|Number
2677692|NCT01429441|Primary|Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular Traction [VMT]) Resolution at Day 28|Pharmacological VMA resolution without anatomical defect, based on SD-OCT and determined by the masked central reading center (CRC), with post-resolution vitrectomy considered as a failure. Missing data were imputed using the last observation carried forward (LOCF) method.|Day 28|Full Analysis Set (FAS): The FAS is the set of all randomized subjects who received the initial treatment, and for whom data of at least 1 post-injection efficacy assessment was present. Two (2) subjects (1 in each treatment group) were excluded from the FAS as they withdrew consent and did not attend any of the post-injection visits.|||Percentage (weighted across strata)||95% Confidence Interval|Number
2677693|NCT01429298|Post-Hoc|Number of Participants Who Reported no Pain or Mild Pain at 30 Minutes||30 minutes|The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)|||Participants|||Count of Participants
2677694|NCT01429298|Post-Hoc|Number of Patients Who Achieved Absolute Pain Intensity Score of 3 or Less at 30 Minutes|"Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable)"|30 minutes|The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)|||Participants|||Count of Participants
2702887|NCT01222715|Other Pre-specified|Levels of Biomarkers Related to the Effect of Temsirolimus on the Unfolded Protein Response||Up to 36 weeks|||||||
2677696|NCT01429298|Primary|Mean Change in Pain Intensity Score From Baseline to 30 Minutes|"Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable). The change in NRS score is calculated by subtracting the score at 30 minutes post treatment from the score at baseline, before treatment. The average of these values was calculated."|30 minutes|The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)|||units on a scale||Standard Deviation|Mean
2677697|NCT01429298|Primary|Number of Participants Who Declined Additional Medication at 30 Minutes|"Amount of patients who choose to forgo additional pain medication at 30 minutes post-baseline when asked the question, Do you want more pain medication?"|30 minutes|The discrepancy between the number of patients enrolled and randomized and the number of patients analyzed is due to: never given IV opioids (10), missing primary outcome data (4), enrolled twice (2), and received IV ketorolac prior to enrollment (9)|||Participants|||Count of Participants
2677698|NCT01429285|Post-Hoc|Pain Intensity Score at 60 Minutes|"Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable)."|60 minutes|The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)|||units on a scale||Inter-Quartile Range|Median
2677699|NCT01429285|Post-Hoc|Number of Patients With a Pain Intensity Score of 3 or Less at 60 Minutes|"Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable)."|60 minutes|The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)|||Participants|||Count of Participants
2677700|NCT01429285|Post-Hoc|Number of Patients With 50% or Greater Decline in Pain Intensity Score From Baseline to 60 Minutes|"Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable). The 50% or greater change in pain score is measured by subtracting the pain score at 60 minutes from the pain score at baseline, then dividing that value by the original baseline value and multiplying by 100% to get a percent change value."|60 minutes|The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)|||Participants|||Count of Participants
2677701|NCT01429285|Post-Hoc|Number of Patients Who Achieved Satisfactory Analgesia at 60 Minutes Post-baseline|"Satisfactory analgesia is defined as the patient declining additional pain medication when asked the question, Do you want more pain medication?. This measure refers only to the answer to this question asked at the 60 minute mark. The Primary Outcome (1. Primary Outcome - Number of Patients with successful treatment) refers to the answering no to this question at 15 minutes or 60 minutes post-baseline."|60 minutes|The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)|||Participants|||Count of Participants
2677702|NCT01429285|Post-Hoc|Number of Patients Who Achieved Satisfactory Analgesia at 15 Minutes Post-baseline|"Satisfactory Analgesia is defined as declining additional pain medication when asked the question, Do you want more pain medication?"|15 minutes|The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)|||Participants|||Count of Participants
2677703|NCT01429285|Secondary|Mean Change in Pain Intensity From Baseline to 60 Minutes|"Pain intensity is measured on the numerical rating scale (NRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable). The change in scores over time is calculated by subtracting the score at 60 minutes from the score at baseline (before treatment). These change values were then averaged."|60 minutes|The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)|||units on a scale||Standard Deviation|Mean
2677704|NCT01429285|Primary|Number of Patients With Successful Treatment|"Number of patients with successful treatment is defined as the number of patients who declined additional pain medication within 1 hour of study entry when asked the question, Do you want more pain medication?. This measure looks at declining pain medication at either 15 minutes or 60 minutes, whereas 4. Post-Hoc refers only to the answer to the question at the 60 minute mark post-baseline."|1 hour|The discrepancy between the number of patients enrolled and randomized and the number analyzed is due to patient never being given IV opioids (13), enrolled twice (10), and missing primary outcome data (8)|||Participants|||Count of Participants
2677705|NCT01429272|Secondary|Remission Rate|Remission defined as a score of <11 on Montgomery-Asberg Depression Rating Scale scores for the final two consecutive visits.|Six weeks|Note numbers do not match the participants flow because participants who did not return for at least one post treatment visit could not be included in the analysis.|||percentage of participants|||Number
2677706|NCT01429272|Primary|Treatment Response|Response to treatment defined as a >50% decrease in Montgomery-Asberg Depression Rating Scale scores for the final two consecutive visits.|Six weeks|Note numbers do not match the participants flow because participants who did not return for at least one post treatment visit could not be included in the analysis.|||Percentage of Participants|||Number
2677707|NCT01429259|Secondary|Meropenem Pharmacodynamics|Meropenem exposures defined from the population model for each participant will be analyzed as a function of the isolated pathogens meropenem minimum inhibitory concentration (MIC) to define the exposure of meropenem associated with an absolute and relative percent change in the Forced Expiratory Volume (FEV1).|14-21 days|||||||
2677708|NCT01429259|Secondary|Practicality of 3 Hour Prolonged Infusion|This will be an intention to treat analysis of all 30 participants receiving meropenem as a 3 hour prolonged infusion. The Cystic Fibrosis Questionnaire-Revised (CFQ-R) will be utilized to assess patient or parent assessments of the burden of the prolonged infusion treatment. The CFQ-R will be administered at the beginning of the study and then within 7 days after completion of meropenem therapy.|14-21 days|||||||
2679444|NCT01411267|Secondary|Inhibition of FLT3 Phosphorylation|PIA samples will be collected pre-treatment and on Days 7, 14, 21 and 28 of Course 1.|4 weeks from therapy start|Nineteen of 22 patients had PIA assessment.|||Participants|||Count of Participants
2677709|NCT01429259|Secondary|Safety|This will be an intention to treat analysis of all 30 participants receiving meropenem as a 3 hour prolonged infusion. Participants will be monitored for any sign of symptom of adverse events throughout the course of the study. An adverse event will be defined as any pathologic or unintended change in the structure (signs), function (symptoms), or chemistry (laboratory values) of the body associated with the use of the study drug.|14-21 days|||||||
2677710|NCT01429259|Primary|Population Pharmacokinetics - Volume of Central Compartment|Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's volume of the central compartment.|During 8 hour dosing interval after 3rd meropenem dose||||L/kg||Standard Deviation|Mean
2677711|NCT01429259|Primary|Population Pharmacokinetics - Total Body Clearance|Based on meropenem concentrations, the pharmacokinetics of the study population will be analyzed to determine each patient's total body clearance.|8 hour dosing interval after 3rd meropenem dose||||L/hr/kg||Standard Deviation|Mean
2677712|NCT01429077|Secondary|Participation in Everyday Activities (Maintenance)||Change in participation in everyday activities from 6 weeks to 12 weeks|||||||
2677713|NCT01429077|Secondary|Functional Communication Skills (Maintenance)||Change in functional communication skills from 6 weeks to 12 weeks|||||||
2677714|NCT01429077|Secondary|Western Aphasia Battery Reading and Writing Scores (Maintenance)||Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks|||||||
2677715|NCT01429077|Secondary|Western Aphasia Battery Aphasia Quotient (Maintenance)||Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks|||||||
2677716|NCT01429077|Secondary|Western Aphasia Battery - Reading and Writing Scores||Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks|||||||
2677717|NCT01429077|Secondary|Participation in Everyday Activities|Measures on CETI, QCL,BOSS, CCRSA.|Change from Baseline in participation in everyday activities at 6 weeks|||||||
2677718|NCT01429077|Secondary|Functional Communication Skills|Scores derived from language sample analyses|Change from Baseline in functional communication skills at 6 weeks|||||||
2677719|NCT01429077|Primary|Language Quotient (LQ) on the Western Aphasia Battery|"Includes a measure of auditory comprehension, oral expression, reading and written expression skills.~The scale ranges from 1 - 100 with 100 being better. The change or gain score from baseline to immediately post-treatment (at 6 weeks) is reported. The larger the change score, the greater the improvement."|Change from Baseline in Western Aphasia Battery LQ at 6 weeks||||units on a scale||Standard Deviation|Mean
2677720|NCT01429064|Primary|Number of Participants With Adverse Events|Adverse events from start of ODM-201 treatment (in ARADES 3104001 study) until end of study visit (in ARADES-EXT 3104002 study). Median duration on study treatment was 11,0 months.|From first dose of study treatment up to 4 weeks after last dose of study treatment|Safety population|||participants|||Number
2677721|NCT01429051|Secondary|Number of Participants With Adverse Events (AEs)|The severity (intensity of each AE was assessed as mild (transient symptoms, no interference with daily activities), moderate (marked symptoms, moderate interference with daily activities), or severe (considerable interference with daily activities) by the investigator. Serious adverse events are defined as any untoward medical occurrence that at any dose results in death or is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect. The investigator assessed each AE as either related or not related to study treatment.|12 weeks|Safety analysis set|||participants|||Number
2677722|NCT01429051|Secondary|Efficacy Phase: General Impression (GI) Score at 60 Minutes After First Dose|"Participants assessed their general impression (GI) of treatment efficacy for treated BTP episodes at 60 minutes after first dose of study drug. The validated, categorical 5-point Verbal Rating Scale (VRS) was used for this assessment and scored as follows:~0 =poor;~1 =fair;~2 =good;~3 =very good;~4 =excellent."|During the efficacy phase (II), at each episode of breakthrough pain, 60 minutes after first dose of study drug.|Efficacy Phase, Full Analysis Set|||units on a scale||95% Confidence Interval|Least Squares Mean
2677723|NCT01429051|Secondary|Efficacy Phase: Proportion of BTP Episodes With a Positive Response Defined as a ≥ 33% or 50% Reduction in Pain Intensity|"Overall responder rate is defined as the proportion of breakthrough pain (BTP) episodes with a positive response to treatment. The following definitions of a positive response were analyzed: • Greater than 33% reduction in PI from time 0; • Greater than or equal to 50% reduction in PI from time 0. Pain intensity was assessed using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain."|During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug|Efficacy Phase, Full Analysis Set|||proportion of breakthrough pain episodes|Participants||Number
2677724|NCT01429051|Secondary|Efficacy Phase: Proportion of BTP Episodes With a Positive Response Defined as a ≥ 1, 2 or 3 Point Reduction in Pain Intensity|"Overall responder rate is defined as the proportion of breakthrough pain (BTP) episodes with a positive response to treatment. The following definitions of a positive response were analyzed: • greater than or equal to 1 point reduction in pain intensity (PI) from time 0, • greater than or equal to 2 point reduction in PI from time 0, and • greater than or equal to 3 point reduction in PI from time 0. Pain intensity was assessed using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain."|During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug|Efficacy Phase, Full Analysis Set|||proportion of breakthrough pain episodes|Participants||Number
2677725|NCT01429051|Secondary|Efficacy Phase: Sum of Pain Intensity Differences (SPID0-60 and SPID0-30) Derived From PI Scores|"The SPID30 and SPID60 represent the average improvement in pain intensity over the 30 minute interval and 60 minute interval, respectively. SPIDt was calculated as the area under the curve (AUC) for Pain Intensity Difference over the time interval 0 to t minutes, respectively, divided by the length of the time interval (t minutes). A positive value is a decrease (improvement) of the pain.~Pain intensity was assessed at 0, 5, 30 and 60 minutes after study drug using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain. PID is calculated as the difference in pain intensity from time 0 to each time point."|During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug|Efficacy Phase, Full Analysis Set|||units on a scale||95% Confidence Interval|Least Squares Mean
2677726|NCT01429051|Secondary|Efficacy Phase: Pain Intensity Difference (PID) at 5, 30, and 60 Minutes After First Dose of Study Drug|"During the efficacy phase participants assessed their pain intensity at each breakthrough pain (BTP) episode at 0, 5, 30 and 60 minutes after first dose using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain. PID is calculated as the difference in pain intensity from time 0 to each time point. A positive value is a decrease (improvement) of the pain; a ≥ 2-point difference is considered as clinically important."|During the efficacy phase (II) each episode of breakthrough pain, at 0, 5, 30 and 60 minutes after study drug.|Efficacy Phase, Full Analysis Set|||units on a scale||95% Confidence Interval|Least Squares Mean
2677727|NCT01429051|Secondary|Incidence of Improvement or Worsening in Nasal Mucosa Sign or Abnormality Score|Medical examination of the nasal cavity by rhinoscopy was performed by an oto-rhino-laryngologist before the start of study treatment and at 12 weeks. Signs and any abnormalities were observed for each nostril using the following 4 points assessment scale: • 0 =not present; • 1 =present in a mild degree; • 2 =present in a moderate degree; • 3 =present in a severe degree. A difference in score of 1 or more from Baseline to the end of treatment represented a worsening, while a negative value indicated an improvement of the observed clinical sign. The oto-rhino-laryngologist also assessed whether worsening of a sign was related to study drug. Assessments for both left and right nostrils are presented together. The incidence is calculated as the number of assessments (n) in the improvement or worsening category divided by the number of assessments with a non-missing score for the Nasal Mucosa or Abnormality assessment. Only those signs or abnormalities with n>0 were included|Baseline and at 12 weeks|Safety Analysis Set, which included all patients who received at least 1 dose of INFS (including the initial test dose) with non-missing assessments.|||proportion of nostril assessments|Participants|95% Confidence Interval|Number
2677728|NCT01429051|Primary|Induction Phase: Pain Intensity Difference at 10 Minutes (PID10) After Treatment|"During the efficacy phase participants assessed their pain intensity at each breakthrough pain (BTP) episode at 0 and 10 minutes after first dose using the 11-point Numerical Rating Scale (NRS) on a scale from 0 to 10, where 0 represents the absence of pain and 10 is worst possible pain. PID10 is calculated as the difference in pain intensity from time 0 to 10 minutes. A positive value is a decrease (improvement) of the pain; a ≥ 2-point difference is considered as clinically important."|During the efficacy phase (II), at each episode of breakthrough pain, at 0 and 10 minutes after first dose of study drug.|The Full Analysis Set consisted of all randomly assigned participants who entered the Efficacy Phase (II) of the trial and were treated for at least 1 BTP episode with double-blind INFS in the Efficacy Phase of the trial.|||units on a scale||95% Confidence Interval|Least Squares Mean
2677729|NCT01428882|Secondary|Rate of Patients and Physician Satisfaction With Sedation|"Endoscopists and patients rated their satisfaction with sedation in a 10-cm visual analogue scale after discharge.The patients were contacted 24-48 h after the procedure to answer a questionnaire regarding if they remembered scope insertion or scope removal and willingness to repeat it with a similar protocol and rated their satisfaction and pain perception from 0 to 10. This phone survey was done by the nurse specifically making the measurements in the endoscopy room, who was blinded to the sedation regimen.~For the interpretation of results of the 0-10 point numerical scale, 0 stands for 'extremely dissatisfied with sedation level during the endoscopic procedure', whereas 10 stands for 'extremely satisfied with sedation level during the endoscopic procedure."|Up to 1 hour after colonoscopy for endoscopists and up to 48 hours for patients||||units on a scale||Full Range|Mean
2677730|NCT01428882|Secondary|Rate of Sedation-related Complications During the Procedure and the Recovery Phases|The following events were considered complications of procedural sedation: a decline in oxygen saturation to less than 85 % longer than 30 s after increasing the oxygen flow rate to 5 L/min and transient propofol interruption, a heart rate less than 40 beats per minute and blood pressure less than 80/50 mmHg. Major complications were defined as need for mechanical ventilation or any cardiorespiratory event requiring anaesthesiologist assistance.|Up to two hours, including colonoscopy performance and recovery period||||participants|||Number
2677731|NCT01428882|Secondary|Duration of Recovery After the Endoscopic Procedure|"After completion of the procedure, the patient stood in the examination room monitored continuously by a nurse. When patients responded to normal verbal command, they were asked to sit up and were offered a drink. This was considered the early recovery time.~If they were able to stand unassisted by the bed and had stable hemodynamics parameters (saturation>90 % on room air and blood pressure and heart rate within 20 % of baseline), they were transferred to a locker room accompanied by a relative. The discharge criteria included ability to stand unassisted and tolerate clear liquids once dressed. Once a patient met discharge criteria, they were allowed to leave at their own discretion"|Up to 1 hour after colonoscopy||||minutes||Full Range|Mean
2677732|NCT01428882|Primary|Level of Sedation Throughout the Entire Procedure|Assessment every two minutes of the level of sedation during the endoscopic procedure, rating it as minimal, moderate or deep.|Up to 1 hour after introduction of the colonoscope||||participants|||Number
2677733|NCT01428765|Primary|Concomitant Medication||Baseline||||participants|||Number
2677734|NCT01428765|Primary|Medical History||Baseline||||participants|||Number
2677735|NCT01428765|Primary|Age Group||Baseline||||participants|||Number
2677736|NCT01428765|Primary|Gender||Baseline||||participants|||Number
2677737|NCT01428765|Primary|Antithrombotic Treatment Choice at Baseline||Baseline||||participants|||Number
2677738|NCT01428765|Primary|HAS-BLED Risk Score|The HAS-BLED score is based on a point system in which 1 point is assigned for hypertension (systolic blood pressure >160 mmHg), 1 point for each of abnormal renal (presence of chronic dialysis or renal transplantation or serum creatinine ≥200 μmol/L) and liver (chronic hepatic disease or biochemical evidence of significant hepatic derangement) function, 1 point each is assigned for stroke, bleeding (previous bleeding history and/or predisposition to bleeding), labile Internation Normalized Ratios (INRs,unstable/high INRs or poor time in therapeutic range), age >65 years and 1 point each for drugs (such as antiplatelet agents, non-steroidal anti-inflammatory drugs) or alcohol.|Baseline||||participants|||Number
2677808|NCT01428063|Secondary|Percentage of Participants With Complete Early Virologic Response (cEVR)|cEVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at week 12.|Week 12|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.|||Percentage of participants|||Number
2677739|NCT01428765|Primary|CHA2DS2-VASc Score|"The CHA2DS2-VASc risk score is based on a point system in which 2 points are assigned for a history of stroke or TIA, or age ≥75; and 1 point each is assigned for age 65-74 years, a hypertension, diabetes, cardiac failure, vascular disease and female sex. On the basis of the risk strata defined in previous guidelines, a CHA2DS2-VASc score of 0 corresponds to low risk, a score of 1 corresponds to intermediate risk, and a score of 2 or more corresponds to high risk."|Baseline||||participants|||Number
2677740|NCT01428765|Primary|CHADS2 Score|CHADS2 score is based on a point system in which 2 points are assigned for a history of stroke or transient ischemic attack and 1 point each is assigned for age equal to or greater more than 75 years, hypertension, diabetes, or clinical heart failure or impaired left ventricular systolic function (generally interpreted as an ejection fraction ≤ 40%).|Baseline||||participants|||Number
2677741|NCT01428713|Primary|To Assess the Efficacy of Oral TA and COCP in Adolescents With Menorrhagia.|"To assess~change in Pictorial Blood Assessment Chart Score (PBAC Score) from baseline to the end of 3 cycles of TA~change in quality of life (QOL) as evaluated by the PedsQL instrument from baseline to the end of 3 cycles of TA~change in Pictorial Blood Assessment Chart Score (PBAC Score) from baseline to the end of 3 cycles of COCP~change in quality of life (QOL) as evaluated by the PedsQL instrument from baseline to the end of 3 cycles of COCP~PBAC score:~Quantitative score to measure menstrual blood loss. Scale range: Minimum - 0 score, Maximum: No maximum Interpretation: Score > 100 indicates heavy menstrual bleeding~Peds QL score:~Score to measure quality of life in children Scale range: Minimum: 0, Maximum 100 Calculation: Subscales are reverse scored (using formula 100 - a x 25) and then all subscales are averaged Eg: Subscale score of 3 is reverse scored as: 100 - (3 x 25) = 25 Interpretation: Higher score indicates better quality of life"|Baseline, 3 cycles|10 patients completed TA and their results were analyzed. 11 patients completed COCP and their results were analyzed.|||Scores on a scale||Standard Error|Mean
2677742|NCT01428661|Primary|Change From Baseline to Endpoint at Week 8 Using the Total Score of the Hamilton Depression Rating Scale (HAM-D)|Hamilton Rating Scale for Depression (HAM-D) assesses the range of symptoms that are most frequently observed in subjects with major depressive disorder (MDD) on a scale from 0 to 52. Higher HAM-D scores indicate more severe levels of depressive symptoms, thus, a negative change from baseline indicates a reduction (or improvement) in depressive symptoms.|8 weeks|The Intent-to-Treat (ITT) Population included any subject randomized into the study that receives a dose of study medication and that has completed at least one post-baseline efficacy measurement while on study medication.|||units on a scale||Standard Error|Mean
2677743|NCT01428583|Other Pre-specified|Mean Change From Baseline in Worst Pain Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|"The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. Pain at its worst in the last 24 hours was reported."|Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|"ITT. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."|||unit on a scale||Standard Deviation|Mean
2677744|NCT01428583|Other Pre-specified|Mean Change From Baseline in Average Pain Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|"The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. Pain on average in the last 24 hours was reported."|Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|"ITT. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."|||unit on a scale||Standard Deviation|Mean
2677745|NCT01428583|Other Pre-specified|Mean Change From Baseline in Pain Right Now Score at Weeks 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination|"The pain intensity scale consisted of 4 questions (pain at its worst in the last 24 hours, pain at its least in the last 24 hours, pain on the average in the last 24 hours and pain right now) each scored on an 11-point numerical rating scale, where 0 = no pain and 10 = pain as bad as you can imagine. Pain right now was reported."|Baseline, Week 1, 4, Months 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 12 or Early Termination (ET)|"ITT. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."|||units on a scale||Standard Deviation|Mean
2677746|NCT01428583|Other Pre-specified|Participants Global Assessment of Treatment Satisfaction|"Participant global assessment of treatment satisfaction was scored on a 5-point categorical scale based on response to the question Please rate your overall satisfaction with the study drug you received? where 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied."|Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, end of treatment|"ITT. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."|||unit on a scale||Standard Deviation|Mean
2677747|NCT01428583|Other Pre-specified|Mean Daily Dose of Immediate-release Oxycodone as Rescue Medication|Immediate-release oxycodone as a single ingredient product was used as a rescue medication only during the first 4 weeks of the treatment period to support the initiation of oxycodone HCl and naltrexone HCl treatment.|Up to Week 4|Data for mean daily dose of immediate-release oxycodone was not reported because as per protocol and analysis plan it was not planned to be summarized.||||||
2677767|NCT01428453|Secondary|Change From Baseline (Day 0) in CSF Albumin Quotients at Week 24|CSF albumin quotient was assessed at Baseline visit (Day 0) and Week 24 (Day 168). Change from Baseline in albumin quotient is summarized. Baseline and Week 24 study visits were taken place at approximately the same time of day in the morning (preferably between 08:00 and 12:00) to improve the reliability of CSF. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value. The data is presented in for adjusted mean and standard error of adjusted mean.|Baseline (Day 0) and Week 24|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Nanograms per Liter||Standard Error|Least Squares Mean
2677748|NCT01428583|Other Pre-specified|Percentage of Participants With Current Opioid Misuse Measure (COMM) Score of 9 or Above|The COMM is a 17-item self-report questionnaire to monitor for aberrant medication-related behaviors among chronic pain participants. Participants are asked to indicate the frequency of individual behaviors on a scale from 0 to 4 (0 = never, 1 = seldom, 2 = sometimes, 3 = often, 4= very often). The total COMM score is the sum of the 17 item scores with a range from 0 to 68. Higher score indicated a higher risk for aberrant medication- related behavior. A score of 9 or higher was defined as high risk for aberrant medication- related behavior.|Baseline, Week 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or early termination|"Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules. Here n signifies those participants who were evaluable at specified time point."|||percentage of participants|||Number
2677749|NCT01428583|Other Pre-specified|Percentage of Participants With Response to Urine Drug Test|Participants with a positive urine drug test for illicit drug substances (marijuana, cocaine, amphetamines, methamphetamines, phencyclidine, and ecstasy), or unexpected drug substances (those other than reported by the participant as therapeutic concomitant medications such as opiates and methadone), or a negative urine test for the expected opioid (oxycodone) was assessed.|Screening, Week 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 or early termination|"Safety analysis set. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."|||percentage of participants|||Number
2677750|NCT01428583|Other Pre-specified|Number of Participants With Rescue Medication (Acetaminophen Tablets)|Participants had acetaminophen up to 2 grams per day during the treatment period of the study as rescue medication.|Baseline- less than (<) Week 1, Week 1-<4, Week 4-<Month 2, Month 2-<3, Month 3-<4, Month 4-< 5, Month 5-<6, Month 6-<7, Month 7-<8, Month8-<9, Month 9-<10, Month 10-<11, Month 11-<12, Month 12-<End of study (2 weeks post end of Month 12)|"Intent-to-treat (ITT) included all participants in the safety analysis set who had at least 1 pain intensity score reported during treatment. Here n signifies those participants who were evaluable at specified time point."|||participants|||Number
2677751|NCT01428583|Other Pre-specified|Mean Daily Dose of Study Medication (Oxycodone Component)||Baseline- less than (<) Week 1, Week 1-<4, Week 4-<Month 2, Month 2-<3, Month 3-<4, Month 4-< 5, Month 5-<6, Month 6-<7, Month 7-<8, Month8-<9, Month 9-<10, Month 10-<11, Month 11-<12, Month 12-<End of study (2 weeks post end of Month 12)|"Safety analysis set. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure and n signifies those participants who were evaluable at specified time point."|||milligram/day||Standard Deviation|Mean
2677752|NCT01428583|Other Pre-specified|Duration of Exposure to Study Medication|Duration of exposure to study medication during the course of the study was assessed.|Baseline up to 2 weeks after last dose|Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.|||days||Full Range|Median
2677753|NCT01428583|Other Pre-specified|Time to Stabilization of Study Medication|Stabilization was considered to have occurred when: total daily dose of oxycodone and naltrexone remained unchanged for greater than or equal to (>=) 3 consecutive days, daily acetaminophen used remained at 1 gram or less and immediate-release oxycodone was not being used as a rescue medication. Days to stabilization = date of stabilization - date of first dose + 1.|Baseline up to Month 12|"Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure."|||days||Full Range|Median
2677754|NCT01428583|Other Pre-specified|Observed Steady-state Plasma Concentrations (Cobs) of 6-Beta-naltrexol|6-Beta-naltrexol was a metabolite of naltrexone.|Week 1, 4, Month 2, 3, 6, 9, 12 or early termination|Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.||||||
2677755|NCT01428583|Other Pre-specified|Observed Steady-state Plasma Concentrations (Cobs) of Naltrexone||Week 1, 4, Month 2, 3, 6, 9, 12 or early termination|Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.||||||
2677756|NCT01428583|Other Pre-specified|Observed Steady-state Plasma Concentrations (Cobs) of Noroxycodone|Noroxycodone was a metabolite of Oxycodone.|Week 1, 4, Month 2, 3, 6, 9, 12 or early termination|Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.||||||
2677757|NCT01428583|Other Pre-specified|Observed Steady-state Plasma Concentrations (Cobs) of Oxycodone||Week 1, 4, Month 2, 3, 6, 9, 12 or early termination|Data was not available to report as PK parameters were plotted by individual participant listings but not summarized for analysis, as per planned analysis.||||||
2677758|NCT01428583|Secondary|Subjective Opiate Withdrawal Scale (SOWS) Score|The presence and level of clinical opiate withdrawal signs or symptoms was determined by participant-reported instrument, subjective opiate withdrawal scale (SOWS). It contains 16 symptoms of opiate withdrawal rated by the participant (anxiety, yawning, sweating, tearing, running nose, goose bumps, shaking, hot flashes, cold flashes, bone or muscle aches, restlessness, nauseous, vomiting, muscle twitch, stomach cramps and feel like using now). Each item is rated on a 5-point scale (0= not at all, 1= a little, 2= moderate, 3= quite a bit, 4= extreme). The total score is the sum of all items, ranging from 0 to 64, higher score indicated severe withdrawal.|Baseline, Week 1, 4, Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12|"Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules. Here n signifies those participants who were evaluable at specified time point."|||units on a scale||Standard Deviation|Mean
2677794|NCT01428115|Secondary|Hospital Anxiety and Depression Score (HADS) - Depression Scores by Visit|HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.|||participants|||Number
2709846|NCT01175018|Secondary|Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >10%||10-14 weeks||||% of participants|||Number
2677759|NCT01428583|Secondary|Percentage of Participants With Clinical Opiate Withdrawal Scale (COWS) Score|The presence and level of clinical opiate withdrawal signs or symptoms was determined by clinician-administered, clinical opiate withdrawal scale (COWS). It contains 11 common opiate withdrawal signs or symptoms rated by clinician (resting pulse rate, gastrointestinal upset, sweating, tremor, restlessness, yawning, pupil size, anxiety or irritability, bone or joint aches, gooseflesh skin, runny nose or tearing), rated on either 3-point, 4-point or 5-point scale, higher score indicated more symptoms of withdrawal. The total score is the sum of all items, ranging from 0 to 48, higher score indicated severe withdrawal. Participants were categorized as less than mild (score 0-4) mild (score 5-12), moderate (score 13-24), moderately severe (score 25-36) or severe (score greater than 36). Percentage of participants with mild (score 5-12), moderate (score 13-24), moderately severe (score 25-36) or severe (score greater than 36) were reported.|Baseline up to Month 12|Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.|||percentage of participants|||Number
2677760|NCT01428583|Secondary|Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) Based on Intensity|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Intensity of adverse event was defined on the basis of severity of an event and was classified as; mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) and severe (interferes significantly with participant's usual function). Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to end of study (2 weeks post-end of month 12)|Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.|||participants|||Number
2677761|NCT01428583|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Adverse Reactions|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE that was attributed to study drug in a participant who received study drug was defined as an adverse reaction. Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to end of study (2 weeks post-end of month 12)|Safety analysis set included all enrolled participants who had at least 1 dose of oxycodone HCl and naltrexone HCl extended-release capsules.|||participants|||Number
2677762|NCT01428453|Secondary|Change From Baseline (Day 0) in CogState Battery Attention Composite Score|CogState battery attention composite score comprised of 2 functional tests including 1) Identification task test assessed visual attention and 2) Trail A test measured psychomotor speed and attention. Composite score calculated by standardizing the total score (sum of all responses from 2 functional test) by formula (Total score at baseline - Week 24) / SD of total score at baseline. The observed composite score ranged from minimum -1.756 and maximum 1.330. Higher score indicated the better attention. Baseline value was defined as the latest Day 0 value and Change from Baseline was calculated as post-dose visit minus Baseline value|Baseline (Day 0) and Week 12 (Day 84), Week 24 (Day 168)|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||Standard Error|Least Squares Mean
2677763|NCT01428453|Secondary|Change From Baseline (Day 0) in CogState Battery Overall Composite Score|CogState battery overall composite score comprised of 8 functional tests 1) Controlled oral word association test measured language fluency, planning and working memory. 2) Category naming test measured semantic fluency, planning and working memory. 3) One-back test measured working memory. 4) Trail B test measured motor speed, visual scanning and visual-motor integration, required attention and cognitive flexibility. 5) Go No-Go task evaluated accuracy and reaction time for each response. 6) International shopping list immediate and delayed recall tests measured episodic memory. 7) Identification task test assessed visual attention. 8) Trail A test measured psychomotor speed and attention. Composite score= total score (sum of all responses from 8 functional test) by formula (Total score at baseline - Week 24) / SD of total score at baseline. Score ranged: -1.070 to 0.907. Lower score indicated the better cognitive status. Change from Baseline= post-dose visit minus Baseline value|Baseline (Day 0) and Week 12 (Day 84), Week 24 (Day 168)|ITT Population. Only those participants available at the specified time points were analyzed. The data is presented in for adjusted mean and standard error of adjusted mean.|||Scores on a scale||Standard Error|Least Squares Mean
2677764|NCT01428453|Secondary|Percentage Inhibition in Plasma Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Activity at Week 24|Plasma Lp-PLA2 was assessed at Baseline visit (Day 0) and Week 24 (Day 168). Percentage inhibition in plasma Lp-PLA2 activity ratio is summarized. Percentage inhibition was calculated by dividing change from Baseline in plasma LpPLA2 by Baseline LpPLA2 multiplied by -100. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value.|Baseline (Day 0) and Week 24|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Percent change||Standard Deviation|Mean
2677765|NCT01428453|Secondary|Change From Baseline (Day 0) in Plasma Levels of Abeta42/Abeta40 Ratio at Week 24|Plasma Abeta biomarkers (Abeta42, Abeta40) were assessed at Baseline visit (Day 0) and Week 24 (Day 168). Change from Baseline in plasma Abeta42/Abeta40 ratio is summarized. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value. The data is presented in for adjusted mean and standard error of adjusted mean.|Baseline (Day 0) and Week 24|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Ratio||Standard Error|Least Squares Mean
2677766|NCT01428453|Secondary|Change From Baseline (Day 0) in Plasma Levels of Abeta42 and Abeta40 at Week 24|Plasma Abeta biomarkers (Abeta42, Abeta40) were assessed at Baseline visit (Day 0) and Week 24 (Day 168). Change from Baseline in plasma Abeta42 and Abeta40 are summarized. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value. The data is presented in for adjusted mean and standard error of adjusted mean.|Baseline (Day 0) and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Nanograms per Liter||Standard Error|Least Squares Mean
2677930|NCT01426438|Secondary|Change in LDL Cholesterol|Change in LDL cholesterol (mg/dL) from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||mg/dL||Inter-Quartile Range|Median
2677768|NCT01428453|Primary|Change From Baseline (Day 0) in the Computerized Test Battery for Cognition (CogState) Battery Working Memory/Executive Function (WM/EF) Composite Score at Week 24|The WM/EF composite score was comprised of 5 functional tests including 1) Controlled oral word association which measured language fluency, planning and working memory, 2) Category naming: It measures semantic fluency, planning and working memory, 3) One-back: This is a measure of working memory. 4) Trail B: This is a measure of motor speed, visual scanning, and visual-motor integration. This test required attention and cognitive flexibility. 5) Go No-Go task: This test evaluate accuracy and reaction time for each response. The composite score calculated by standardizing the total score: sum of all responses obtained from these 5 functional test by using the formula (Total score of ITT population at baseline - Total score at Week 24) /standard deviation of mean total mean score at baseline. The observed composite score ranged from minimum -1.474 and maximum 1.596. Lower score means better cognitive status. Change from Baseline was calculated as post-dose visit minus Baseline value.|Baseline (Day 0) and Week 24|ITT Population. Only those participants with data available at the indicated time points were analyzed. The data is presented in for adjusted mean and standard error of adjusted mean.|||Scores on a scale||Standard Error|Least Squares Mean
2677769|NCT01428453|Primary|Change From Baseline (Day 0) in CSF Tau and Phosphorylated Tau (P-tau) Measures at Week 24|CSF tau and P-tau were assessed at Baseline visit (Day 0) and Week 24 (Day 168). Change from Baseline in CSF tau and P-tau was summarized. Baseline and Week 24 study visits were taken place at approximately the same time of day in the morning (preferably between 08:00 and 12:00) to improve the reliability of CSF. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value. The data is presented in for adjusted mean and standard error of adjusted mean.|Baseline (Day 0) and Week 24|ITT Population. Only those participants available at the specified time points were analyzed.|||Nanograms per Liter||Standard Error|Least Squares Mean
2677770|NCT01428453|Primary|Change From Baseline (Day 0) in CSF Abeta42/ Abeta40 Ratio at Week 24|CSF Abeta biomarkers (Abeta42, Abeta40) were assessed at Baseline visit (Day 0) and Week 24 (Day 168). Change from Baseline in CSF Abeta42/Abeta40 ratio is summarized. Baseline and Week 24 study visits were taken place at approximately the same time of day in the morning (preferably between 08:00 and 12:00) to improve the reliability of CSF. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value. The data is presented in for adjusted mean and standard error of adjusted mean.|Baseline (Day 0) and Week 24|ITT Population. Only those participants with data available at the indicated time points were analyzed.|||Ratio||Standard Error|Least Squares Mean
2677771|NCT01428453|Primary|Change From Baseline (Day 0) in Cerebral Spinal Fluid (CSF) Amyloid Beta Peptide (Abeta) 42 and Abeta40 at Week 24|CSF Abeta biomarkers (Abeta42, Abeta40) were assessed at Baseline visit (Day 0) and Week 24 (Day 168). Change from Baseline in CSF Abeta42 and Abeta40 are summarized. Baseline and Week 24 study visits were taken place at approximately the same time of day in the morning (preferably between 08:00 and 12:00) to improve the reliability of CSF. Baseline value was defined as the latest Day 0 value. Change from Baseline was calculated as post-dose (Week 24) visit value minus Baseline value. The data is presented in for adjusted mean and standard error of adjusted mean.|Baseline (Day 0) and Week 24|ITT population. Only those participants available at the specified time points were analyzed.|||Nanograms per Liter||Standard Error|Least Squares Mean
2677772|NCT01428336|Secondary|Peak Total Cortisol Values|Peak total cortisol values during cortrosyn stimulation tests(CST)|1 hour for the CST interventions and 2 hour for the ITT interventions||||ug/dl||Full Range|Median
2677773|NCT01428336|Secondary|Pearson Correlation of Free Cortisol Values During CSTs With ITT|Correlation of free cortisol levels of 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table|1 hour for the CST interventions and 2 hour for the ITT interventions|Correlation of free cortisol levels with 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table. The two groups of patients and volunteers were combined to get a full range of values for each intervention.|||correlation coefficient||95% Confidence Interval|Number
2677774|NCT01428336|Primary|Pearson Correlation of the Total Cortisol Levels Between the ITT and CSTs|Correlation of total cortisol levels of 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table|1 hour for the CST interventions and 2 hour for the ITT interventions|Correlation of total cortisol levels with 1 ug, 25 ug and 250 ug cortrosyn stimulation test with Insulin Tolerance test is described in the outcome table. The two groups of patients and volunteers were combined to get a full range of values for each intervention.|||correlation coefficient||95% Confidence Interval|Number
2677775|NCT01428258|Other Pre-specified|Bone Mineral Density Determined by Dual-energy X-ray Absorptiometry (DXA) Scan|Subjects will have a single DXA test to assess bone mineral density of the lumbar spine and total body during the first dietary treatment that they are randomly assigned to start with.|once during first 3 week dietary treatment|||||||
2677776|NCT01428258|Secondary|N-terminal Telopeptide (NTX) Plasma Concentration at Day 22|Plasma concentration of NTX was determined as a measure of bone resorption; higher levels indicate greater bone breakdown|day 22 of each dietary treatment|Samples were not obtained from 3 subjects due to a collection error by research staff. Thus the sample size is reduced from 30 to 27.|||nmol per liter bone collagen equivalents||Standard Error|Mean
2677777|NCT01428258|Secondary|Bone-specific Alkaline Phosphatase (BSAP) Plasma Concentration at Day 22|Plasma concentration of BSAP was determined as a measure of bone turnover.|day 22 of each dietary treatment|Samples were not obtained from 4 subjects due to a collection error by research staff. Thus the sample size is reduced from 30 to 26.|||micro gram per liter||Standard Error|Mean
2677795|NCT01428115|Secondary|Hospital Anxiety and Depression Score (HADS) - Anxiety Scores by Visit|HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.|||participants|||Number
2709847|NCT01175018|Secondary|Percentage of Patients in Each Group With Left Ventricular Ejection Fraction Change >5%||10-14 weeks||||% of participants|||Number
2677778|NCT01428258|Secondary|Comparison of Phe Concentrations in Plasma With Concentrations in Dried Blood Spots|Concentrations of Phe in plasma and in dried blood spots collected simultaneously by subjects will be compared using 2 methodologies, regardless of intervention. At each of the 4 study visits (baseline and final for each dietary treatment): 1) venipuncture was used to collect blood and plasma was isolated and analyzed for Phe with ion exchange chromatography and 2) subjects were asked right after the venipuncture to spot their blood on filter paper for analysis of Phe with tandem mass spectroscopy (MS/MS). The discrepancy in Phe concentrations with these 2 methods was compared for each sample pair using Bland-Altman statistical analysis. Each subject should have had 4 sample pairs, 29 x 4 = 116, but we ended up with only 110 sample pairs, as explained below.|4 times total, 2 per treatment|Analysis of sample pairs is required to determine the discrepancy in Phe levels with the 2 methods. Each subject should have had 4 sample pairs, 29 x 4 = 116, but we ended up with only 110 sample pairs. The explanation for the difference is that several subjects did not provide dried blood spots because research staff forgot to obtain them.|||micro moles per liter||Standard Error|Mean
2677779|NCT01428258|Secondary|Vitamin D (25-OH) Plasma Concentration at Day 22|Vitamin D was measured as a measure of the capacity for calcium absorption. Higher levels of plasma vitamin D are consistent with higher calcium absorption.|day 22 of each dietary treatment||||ng per ml||Standard Error|Mean
2677780|NCT01428258|Secondary|Executive Function Assessed by BRIEF|Completion of a standardized test, the Behavior Rating Inventory of Executive Function (BRIEF), by each subject for the GMP diet and the AA diet. Values are T-scores which have a mean of 50 points and a SD of 10 points. A T score of <50 is considered within the normative range. Data are analyzed with a paired t-test.|day 22 of each dietary treatment||||T score||Standard Error|Mean
2677781|NCT01428258|Secondary|Dietary Compliance|Compliance with the glycomacropeptide and amino acid dietary treatments will be assessed by comparison of the intake of medical food in grams of protein from medical food per day based on subject completion of 3-day food records prior to the final study visit on day 22. Statistical analysis for a dietary treatment effect will consist of ANOVA.|3 week dietary treatment||||g protein from MF/kg/day||Standard Error|Mean
2677782|NCT01428258|Primary|Change in the Plasma Phenylalanine Concentration of PKU Subjects Fed the Glycomacropeptide Diet Compared With the Change When Fed the Amino Acid Diet|Plasma will be collected at each base week and after 3 weeks on each of the dietary treatments, glycomacropeptide and amino acid, following an overnight fast. Plasma phenylalanine concentration (along with the complete profile of free amino acids) will be determined with an amino acid analyzer in the Wisconsin State Lab of Hygiene. Statistical analysis to determine the significance of the change in plasma phe concentration when comparing the 2 diets will consist of ANCOVA with covariates for baseline Phe and dietary Phe intake. The change in plasma Phe concentration from day 22 (final) to day 1 (baseline) was determined after adjusting for baseline Phe level and dietary Phe intake.|baseline to day 22 on each diet||||micro moles per liter plasma||Standard Error|Mean
2677783|NCT01428219|Secondary|Median Time to PSA Progression||18 months||||weeks||Full Range|Median
2677784|NCT01428219|Secondary|The Number of Patients That Are Progression Free by PSA|The number of patients that are progression free by PSA at 12 weeks|12 weeks||||Participants|||Count of Participants
2677785|NCT01428219|Secondary|Duration of Response.|Duration of response in soft tissue and bone.|18 months||||weeks||Full Range|Median
2677786|NCT01428219|Secondary|Response Proportion in Both Soft Tissue and Bone Disease.|The percentage of participants that respond in soft tissue and bone disease.|18 months||||percentage of participants|||Number
2677787|NCT01428219|Secondary|Progression-free Survival|The percentage of participants alive without progression at 12 weeks|12 weeks||||percentage of participants||95% Confidence Interval|Number
2677788|NCT01428219|Secondary|Mean Fold Change in Bone Metabolism Biomarker Expression With Cabozantinib|Mean fold change in markers of bone metabolism in bone and serum with cabozantinib. Bone biomarkers include Osteocalcin, NTx, TRAcP, BMP2, SOST, BAP, CICP|18 months||||unitless||Standard Deviation|Mean
2677789|NCT01428219|Secondary|Incidence of Adverse Events (AEs) Related to Treatment|The incidence of grades 1-3 AEs, by CTCAE 4.0 category, either possibly, probably or definitely related to treatment. The NCI Common Terminology Criteria for Adverse Events (CTCAE) is a descriptive terminology which can be utilized for AE reporting.|18 months||||adverse events reported|||Number
2677790|NCT01428219|Primary|Percentage of Participants Who Remain Progression-free at 12 Weeks|Efficacy will be measured by the proportion of participants who remain progression-free at 12 weeks after initiation of the study. RECIST 1.1 will be used to measure progression. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or the appearance of one or more new lesions. Kaplan-Meier methods will be used to report progression-free survival.|12 weeks after participant initiates study||||Percentage of participants||95% Confidence Interval|Number
2677791|NCT01428193|Primary|Slope of the Percent Change in Luteinizing Hormone (LH) Pulses as a Function of Day 7 Progesterone Level|The primary outcome variable for the study is the slope of the percent change in LH pulses as a function of day 7 progesterone level.|3 weeks after flutamide treatment|One subject completed the study but had not taken the study medication so her data is unusable. The second subject completed the study. However, no data were formally analyzed. We were subsequently unable to recruit any additional subjects.|||percentage of slope change|||Number
2677792|NCT01428128|Secondary|Complete Blood Count (CBC)|Another objective of this trial is to assess if arsenic protects the blood counts that are adversely affected by chemotherapy|Day 9 of chemotherapy|Data was not collected from CBC at 9 days||||||
2677793|NCT01428128|Primary|Dose of Arsenic That Blocks Activation of p53|A main objective of this trial is to find the dose of arsenic that blocks the activation of p53. Blockage will reduce the amount of p53 production as measured by Western Blot.|Day 1 of chemotherapy||||mg/kg|||Number
2677796|NCT01428115|Secondary|State Trait Anxiety Index (STAI) Trait Scores by Visit|The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.|||scores on a scale||Standard Deviation|Mean
2709848|NCT01175018|Secondary|Percentage of Patients in Each Group With Adverse Remodeling (LVESVi Increase >10%)||10-14 weeks||||% of participants|||Number
2677797|NCT01428115|Secondary|State Trait Anxiety Index (STAI) State Scores by Visit|The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.|||scores on a scale||Standard Deviation|Mean
2677798|NCT01428115|Secondary|Harvey-Bradshaw Index (HBI) Scores by Visit|Harvey-Bradshaw Index (HBI) is for use in the assessment and quantification of symptoms and the present level of disease activity of patients with Crohn's disease. It is a validated clinical index for Crohn's disease, including the 5 categories of: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25 with higher scores indicating higher disease activity. The scores were classified as follows: less than 5 is remission, 5 to 7 is mild, 8 to 16 is moderate, and greater than 16 is severe.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.|||participants|||Number
2677799|NCT01428115|Secondary|Short Inflammatory Bowel Disease Questionnaire (sIBDQ) Scores by Visit|The sIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL). A higher score indicates a better HRQoL.|Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method.|||scores on a scale||Standard Deviation|Mean
2677800|NCT01428115|Primary|Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab|HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.|Baseline and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.|||participants|||Number
2677801|NCT01428115|Primary|Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab|HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.|Baseline and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.|||participants|||Number
2677802|NCT01428115|Primary|Change in State Trait Anxiety Index (STAI) Trait Scores From Baseline to After 6 Months of Treatment With Adalimumab|The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.|Baseline and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.|||scores on a scale||Standard Deviation|Mean
2677803|NCT01428115|Primary|Change in State Trait Anxiety Index (STAI) State Scores From Baseline to After 6 Months of Treatment With Adalimumab|The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.|Baseline and Visit 3 [Month 6]|All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.|||scores on a scale||Standard Deviation|Mean
2677804|NCT01428076|Primary|Weight-adjusted Polidocanol Cmax (Serum)|Cmax measured and adjusted for weight|pharmacokinetics measured- predose, 1, 4, 5, 7, 9, 11, 14, 15, 17, 20, 25, 30 minutes post dose, 1, 2, 3, 4, 5, 6, 8 hours post dose|PK population|||ng/mL||Standard Deviation|Mean
2677805|NCT01428063|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.|For AEs: Day 1 until last visit. For SAEs: Day 1 until 30 days post discontinuation of dosing or participation|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.|||Participants|||Number
2677806|NCT01428063|Secondary|Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)|SVR24 was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.|Week 24 (Follow-up)|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.|||Percentage of participants|||Number
2677807|NCT01428063|Secondary|Percentage of Participants With End of the Treatment Response (EOTR)|EOTR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at end of treatment.|End of the study (Week 24)|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.|||Percentage of participants|||Number
2677931|NCT01426438|Secondary|Change in Non-HDL Cholesterol|Change in non-HDL Cholesterol (mg/dL) from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||mg/dL||Inter-Quartile Range|Median
2677809|NCT01428063|Secondary|Percentage of Participants With Extended Rapid Virologic Response (eRVR)|eRVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at both weeks 4 and 12.|Week 4 and 12|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.|||Percentage of participants|||Number
2677810|NCT01428063|Secondary|Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4|RVR was defined as the percentage of participants with hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at Week 4.|Week 4|The analysis was performed in all treated participants defined as participants who received at least 1 dose of study therapy.|||Percentage of participants|||Number
2677811|NCT01428063|Secondary|Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.|Week 12 (Follow-up period)|The analysis was performed in all treated participants who did not exhibit Genotype 1. One subject with indeterminate genotype in the Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin Arm/Group was excluded from the analysis|||Percentage of participants||95% Confidence Interval|Number
2677812|NCT01428063|Primary|Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV)|SVR12 defined as HCV RNA<limit of quantitation at follow-up Week 12. Nonresponder (NR)=prior NR to pegIFN-2a or ribavirin.|Week 12 (Follow-up period)|Participants with genotype 1 HCV who received at least 1 dose of study drug|||Percentage of participants||95% Confidence Interval|Number
2677813|NCT01428024|Secondary|Subject Diary for 14 Days After Initial Treatment|"To evaluate the acute safety profile (bruising, itching, pain, redness, swelling and tenderness) in terms of a 14-day subject diary after initial treatment.~Subjects still reporting one or more of the symptoms; bruising, itching, pain, redness, swelling and tenderness in the diary at day 14."|2 weeks after initial treatment||||participants|||Number
2677814|NCT01428024|Secondary|Subject Satisfaction Questionnaire|"To evaluate subjects satisfaction in terms of a subject satisfaction questionnaire at week 8 after treatment.~The subject satisfaction questionnaire consists of questions regarding the looks, appearance, disomfort, and satisfaction regarding the treatment of the lips.~The question that will be referred to is: How satisfied are you today with (the look of) your lips ?"|Week 8||||percentage satisfied subjects|||Number
2677815|NCT01428024|Secondary|MLFS (Medicis Lip Fullness Scale) at Week 8|To evaluate the efficacy in terms of Medicis Lip Fullness Scale (MLFS) score by live assessment performed separately by the treating and the independent investigators in the Restylane Lip Volume group. The scale has five levels: Very thin, thin, median, full, very full. Treatment success is defined as at least one grade increase.|week 8 - change from baseline||||percentage improved subjects||95% Confidence Interval|Number
2677816|NCT01428024|Secondary|GEIS (Global Esthetic Improvement Scale) Assessed by the Independent Evaluator at Week 36 After Treatment|To evaluate esthetic change of lips from baseline as judged by the independent evaluator using GEIS at week 2, 4, 12, 26 and 36. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change, worse.|week 36 - change from baseline||||percentage improved subjects||95% Confidence Interval|Number
2677817|NCT01428024|Secondary|GEIS (Global Esthetic Improvement Scale) Assessed by the Treating Investigator at Week 36 After Treatment|To evaluate esthetic change of lips from baseline as judged by the treating investigator using GEIS at week 36. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change.|week 36 - change from baseline||||percentage improved subjects||95% Confidence Interval|Number
2677818|NCT01428024|Secondary|GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 36 After Treatment|To evaluate esthetic change of lips from baseline as judged by the subjects using GEIS at week 36. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change, worse.|week 36 - change from baseline|"Restylane Lip Volume: One subject withdrew consent after the 8-week visit and thus did not perform the GEIS evaluation at 36 weeks.~Restylane Lip Refresh: Two subjects did not perform the GEIS evaluation at 36 weeks."|||percentage improved subjects||95% Confidence Interval|Number
2677819|NCT01428024|Primary|GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment|To evaluate esthetic change of lips from baseline as judged by the subjects using GEIS. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change, worse.|At week 8 - change of lips from baseline|One subject did not perform GEIS evaluation at the 8-week visit and withdrew consent after the visit|||percentage improved subjects||95% Confidence Interval|Number
2677820|NCT01427972|Other Pre-specified|The Number of Participants Who Died While on Study||Baseline up to end of Treatment Period 2 plus 10-day follow-up (80 days)|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2677821|NCT01427972|Secondary|PK: Maximum Plasma Concentration (Cmax) of LY2623091||Predose, 1, 2, 4, 8, 12, and 24 hours postdose on Day 20 of Treatment Periods 1 and 2|All participants who received LY2623091and had Cmax values. Participants were analyzed based on the treatment they received.|||nanograms/milliliter (ng/mL)||Standard Deviation|Mean
2677822|NCT01427972|Secondary|Pharmacokinetics (PK): Area Under the Plasma Concentration Time Curve During the Dosing Period of LY2623091 (AUC0-τ)||Predose, 1, 2, 4, 8, 12, and 24 hours postdose on Day 20 of Treatment Periods 1 and 2|All participants who received LY2623091 and had AUC0-τ values. Participants were analyzed based on the treatment they received.|||hours*nanogram/milliliter (h*ng/mL)||Standard Deviation|Mean
2677823|NCT01427972|Secondary|Change From Baseline to Day 21 in Potassium Clearance Following an Oral Potassium Challenge|Urine potassium clearance is defined as the amount of renal potassium excreted per volume of urine from participant's pooled urine. The oral potassium challenge consisted of 35 milliequivalents (mEq) potassium administered over 10 minutes as a flavored potassium chloride solution. Change was calculated as (Day 21 values) minus (baseline values).|Over 0-6 hours at Baseline and on Day 21|All participants who received any study drug and had potassium clearance values. Participants were analyzed based on the treatment they received.|||Hour*millimoles per liter (h*mmol/L)||Standard Deviation|Mean
2677932|NCT01426438|Secondary|Change in HDL Particles|Change in total HDL particles from week 0 to week 24|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||nmol/L||Inter-Quartile Range|Median
2677824|NCT01427972|Primary|Change From Baseline to Day 21 in Proteinuria Based on 24-hours Pooled Urine|Proteinuria was the presence of excess serum protein in the urine. Proteinuria was calculated for each participant after each treatment period. Change was calculated as (Day 21 post-treatment value) minus (baseline value).|Over 24 hours at Baseline and on Day 21|All participants who received any study drug and had proteinuria values. Participants were analyzed based on the treatment they received.|||milligrams/24 hours (mg/24 h)||Standard Deviation|Mean
2677825|NCT01427933|Other Pre-specified|Number of Participants With Adverse Events (AE) and Participants Who Died|Participants who died or who had clinically significant events defined as serious AEs (SAEs) and other non-serious AEs (regardless of causality). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline up to end of treatment and within 30 days of last dose of study drug (22.6 months)|All randomized participants who received at least 1 dose of study drug and according to the treatment received.|||participants|||Number
2677826|NCT01427933|Secondary|Number of Participants With Anti-Ramucirumab Antibodies|The number of participants who developed treatment-emergent antibody responses after baseline. The antibody test can produce positive results in participants without ramucirumab exposure. Treatment emergent anti-ramucirumab antibody positive was defined as: when baseline titer was greater than 0 and post baseline titer was equal to or greater than 4-fold the baseline titer or if the baseline titer was not detected and post baseline titer is equal to or greater than a value of 20.|Day 1 of Cycle 1, Cycle 3, Cycle 5 and 30 days after last dose of study drug up to 17.7 months|All randomized participants who received at least 1 dose of study drug and assessed for treatment emergent antibodies.|||participants|||Number
2677827|NCT01427933|Secondary|Change in Tumor Size (CTS)|CTS was defines as the change from baseline measurement of target lesions to the post treatment measurement in participants with measurable disease. Change was assessed using radiographic imagining. Log ratio calculated as: log of (tumor size post baseline) divided by (tumor size at baseline). A negative result indicated a shrinking tumor.|Baseline, 6 weeks|All participants with measurable disease at baseline and at 6 weeks.|||log ratio||Standard Deviation|Mean
2677828|NCT01427933|Secondary|Duration of Response (DOR) Time of Response to Progressive Disease|DOR was measured from the time criteria were met for first objectively recorded CR or PR until first date criteria for PD was met or death. Response defined using RECIST v1.1 criteria. CR defined as disappearance of all lesions and pathological lymph nodes reduction in short axis to <10 mm. PR was defined as ≥30% decrease in sum of diameter (SOD) of target lesions. PD defined ≥20% increase in SOD of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants who were not known to have died and who did not have PD were censored at the date of the last tumor assessment prior to the date of any subsequent systemic anticancer therapy.|Time from Observed CR or PR to PD up to 12.1 months|ITT population: all participants according to their randomized treatment group and who had CR or PR. Participants censored: Ramucirumab+Eribulin=1, Eribulin=3.|||months||95% Confidence Interval|Median
2677829|NCT01427933|Secondary|Objective Response Rate (ORR) Percentage of Participants With Measurable Disease Achieving a Best Overall Response of Partial Response (PR) or Complete Response (CR)|ORR was defined as the percentage of participants with measurable disease achieving a best overall response of PR or CR as defined by RECIST v.1.1. CR defined as disappearance of all lesions and pathological lymph nodes reduction in short axis to <10 mm. PR was defined as ≥30% decrease in SOD of target lesions. Participants who did not have any post baseline tumor response assessments for any reason were considered non-responders and included in the denominator when calculating the response rate. ORR for each treatment arm calculated as: [(CR + PR in the treatment arm) divided by (total number of participants in the treatment arm)] x 100.|Start of treatment until documented CR or PR up to 16.5 months|ITT population: all participants according to their randomized treatment group.|||percentage of participants||95% Confidence Interval|Number
2677830|NCT01427933|Secondary|Overall Survival (OS) Randomization to Date of Death From Any Cause|Time from the date of randomization to the date of death from any cause. For participants who were not known to have died as of the data-inclusion cut-off date, OS data were censored on the last date the participants were known to be alive prior to that cut-off date.|Randomization to date of death from any cause up to 28.6 months|ITT Population: All randomized participants. Participants censored: Ramucirumab and Eribulin=24 , Eribulin Monotherapy=28|||Months||95% Confidence Interval|Median
2677831|NCT01427933|Primary|Progression‐Free Survival (PFS)|PFS was defined as time from date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria or death from any cause, whichever is first. Progressive disease (PD) defined as ≥20% increase in sum of diameter (SOD) of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants with no baseline disease assessment were censored at randomization date, regardless of whether or not objectively determined PD or death was observed; participants not known to have died or to have objective progression as of data inclusion cutoff date were censored at last post baseline radiological assessment date or randomization date, if there was no post baseline radiological assessment.|Start of treatment until documented disease progression or death from any cause up to 16.5 months|Intent-to-treat Population (ITT): all participants according to their randomized treatment group. Participants censored: Ramucirumab+Eribulin=14; Eribulin=17.|||months||95% Confidence Interval|Median
2677832|NCT01427920|Secondary|Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score|From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.|Week 20|Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 17 subjects did not contribute to data.|||scores on a scale||Standard Deviation|Mean
2677833|NCT01427920|Secondary|Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score|From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.|Week 4|Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 20 subjects did not contribute to data.|||scores on a scale||Standard Deviation|Mean
2677834|NCT01427920|Secondary|Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score|From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.|Week 0|Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 10 subjects did not contribute to data.|||scores on a scale||Standard Deviation|Mean
2677835|NCT01427920|Secondary|Number of Treatment Emergent Hypoglycaemic Episodes|A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of trial product, and no later than one day after product administration. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to week 20|Safety analysis set included all subjects who received at least one dose of BIAsp 30. One subject did not contribute to data.|||episodes|||Number
2677836|NCT01427920|Secondary|Change in Fasting Plasma Glucose (FPG) (Central Laboratory Values)|Estimated mean change from baseline in FPG after 20 Weeks of treatment|Week 0, week 20|Full analysis set (FAS) - analysis included endpoint derived after 20 weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 13 subjects did not contribute to the statistical analysis after Week 20.|||mmol/L||Standard Error|Least Squares Mean
2677837|NCT01427920|Primary|Change in HbA1c (Glycosylated Haemoglobin) - PP|Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in per protocol (PP) analysis set.|Week 0, week 20|Per protocol (PP) analysis set - analysis included subjects exposed to BIAsp 30 for more than 12 weeks without any major protocol violations. 24 subjects did not contribute to the statistical analysis after Week 20.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
2677838|NCT01427920|Primary|Change in HbA1c (Glycosylated Haemoglobin) - FAS|Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).|Week 0, week 20|Full analysis set (FAS) - analysis included endpoint derived after 20 Weeks of treatment and missing data was imputed using last observation carried forward (LOCF) where any post-baseline measurements were available. 13 subjects did not contribute to the statistical analysis after Week 20.|||percentage of glycosylated haemoglobin||Standard Error|Least Squares Mean
2677839|NCT01427907|Primary|Serum Phosphorus Levels|The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject|2 weeks|Modified intent-to-treat: subjects who were randomized, received at least one prescribed dose of the study medication and provided at least one of the last 4 laboratory assessments of each treatment period|||mg/dL||Standard Deviation|Mean
2677840|NCT01427881|Secondary|Graft Failure|Descriptive statistics will be used to assess the incidence of primary graft failure and secondary graft failure. Primary graft failure is defined as failure to achieve a sustained neutrophil count of >= 500/uL by >= 28 days post-transplant. Secondary graft failure is defined as the decline in neutrophil count to < 500/uL after achieving engraftment which is unrelated to infection or drug effect and is unresponsive to stimulation by growth factors.|By greater than or equal to 28 days post-transplant||||percentage of patients|||Number
2677841|NCT01427881|Secondary|Hematologic Recovery|Descriptive statistics will be used to assess the median days of neutrophil and platelet recovery. The day of neutrophil recovery is defined as the first day of three consecutive lab values on different days, after the conditioning regimen-induced nadir of blood counts, that the absolute neutrophil count is > 500/uL. The day of platelet recovery is defined as the first day of three consecutive lab values on different days, after the conditioning regimen-induced nadir of blood counts, that the platelet count is >= 20,000/uL without platelet transfusion support in the seven days prior.|Up to day +100||||days||Full Range|Median
2677842|NCT01427881|Secondary|Disease-free Survival|Disease-free survival will be evaluated as Kaplan-Meier estimates.|At 1 year post-transplant||||percentage of patients||95% Confidence Interval|Number
2677843|NCT01427881|Secondary|Overall Survival|Overall survival will be evaluated as Kaplan-Meier estimates.|At 1 year post-transplant||||percentage of patients||95% Confidence Interval|Number
2677844|NCT01427881|Secondary|Non-relapse Mortality|Defined as death in the absence of recurrent or progressive malignancy after HCT. Non-relapse morality will be assessed with the use of cumulative incidence plots. This secondary endpoint will be characterized and presented as a cumulative incidence.|At 2 years||||percentage of patients||95% Confidence Interval|Number
2677845|NCT01427881|Secondary|Persistent or Recurrent Malignancy After HCT|Recurrent or progressive malignancy will be assessed with the use of cumulative incidence plots. Recurrent malignancy will be defined by hematologic criteria. Recurrent malignancy will also be defined as any unplanned medical intervention designed to prevent progression of malignant disease in patients who have molecular, cytogenetic or flow-cytometric evidence of malignant cells after transplantation.|At 2 years||||percentage of patients||95% Confidence Interval|Number
2677846|NCT01427881|Secondary|Duration of Systemic Immunosuppressive Treatment|The need for additional immunosuppressive treatment with agents other than those used for prophylaxis, the reasons for their administration (acute GVHD, chronic GVHD, or other reasons) and the duration of its administration will be determined. Patients will be monitored to determine the duration of systemic immunosuppressive treatment. Primary and secondary treatment of acute GVHD and withdrawal of systemic immunosuppressive treatment will be assessed with the use of cumulative incidence plots.|Up to 5 years|This data was not collected.||||||
2677847|NCT01427881|Secondary|Grades II-IV and III-IV Acute GVHD|Grades II-IV and III-IV GVHD will be assessed with the use of cumulative incidence plots.|Through day +100 post-transplant||||percentage of patients|||Number
2677848|NCT01427881|Secondary|Donor Engraftment|Donor engraftment is defined as the count (percent) of patients with full donor chimerism. Full donor chimerism is defined as at least 95% donor CD3 cells in peripheral blood.|At day 28||||Participants|||Count of Participants
2677849|NCT01427881|Primary|Chronic GVHD Requiring Systemic Immunosuppressive Treatment|Chronic GVHD will be defined by National Institutes of Health (NIH) criteria and requiring systemic treatment. A reduction in the cumulative incidence of GVHD from ~35% to ~15% at 1 year would represent a reasonable goal. A sample size of 42 patients provides 90% power to observe such a difference with one-side 5% type-1 error.|At 1 year after transplantation||||percent of patients||95% Confidence Interval|Number
2677850|NCT01427803|Secondary|Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose|Percentage of dosing occasions where a dose was taken less than 22 hours after the most recent previous dose. 22 hrs was chosen to allow for some imprecision in subjects' recollection|28 days|Participants in Patterns of Use cohort who took the product|||Percentage of dosing occasions|Participants||Number
2677851|NCT01427803|Secondary|Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose|Percentage of participants where a dose was taken less than 22 hours after the most recent previous dose thus exceeding the label directions. 22 hrs was chosen to allow for some imprecision in subjects' recollection.|28 days|Participants in Patterns of Use cohort who took the product|||Percentage of participants|||Number
2677852|NCT01427803|Secondary|Percentage of Dosing Occasions Where More Than One Tablet Was Taken|Percentage of dosing occasions where more than one tablet was taken thus exceeding the label directions.|28 days|Participants in Patterns of Use cohort who took the product|||Percentage of dosing occasions|Participants||Number
2677853|NCT01427803|Secondary|Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken|Percentage of participants with at least one dosing occasion where more than one tablet was taken thus exceeding the label directions.|28 days|Participants in Patterns of Use cohort who took the product|||Percentage of participants|||Number
2677854|NCT01427803|Secondary|Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day|Percentage of participants who took product with mean daily use >/= 2 tablets /use day thus exceeding the label directions on any use day.|28 days|Participants in Patterns of Use User Population who had at least 10 use days of the product|||Percentage of participants|||Number
2677855|NCT01427803|Secondary|Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days|Percentage of participants took >/= 2 tablets/use day in any 10 use days thus exceeding the label directions during a treatment course.|28 days|Participants in Patterns of Use User Population who had at least 10 use days of the product|||Percentage of participants|||Number
2677856|NCT01427803|Secondary|Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course|"This endpoint was an assessment of whether the rate of non-therapeutic misuse exceeded the pre-defined acceptable threshold for non-therapeutic misuse. The difference lay in the estimation of misuse in the Patterns of Use Cohort by using 10-day treatment courses rather than by use day. A treatment course for each subject began on the first day they recorded taking one or more tablets which was followed by nine consecutive evaluable days."|28 days|Participants in Patterns of Use cohort who took the product + Reasons for misuse interviewed population|||Percentage of participants|||Number
2677857|NCT01427803|Secondary|Non-therapeutic Reasons for Misuse|Those subjects in the Reasons for Misuse Cohort who did not state misuse due to need for additional pain relief were categorized to Non-therapeutic misuse.|28 days|Participants in Reason for Misuse cohort who misused the product due to non-therapeutic reasons were included in this analysis|||Participants|||Number
2677858|NCT01427803|Primary|Estimated Percentage of Misuse for Non-Therapeutic Reasons|The primary objective of this trial was to determine the percentage of non-therapeutic misuse. Two aspects of consumer use of Aleve 24 Hour were examined: the frequency at which consumers exceeded the label-defined daily dose modified by those who did so for non-therapeutic reasons.|28 days|Participants in Patterns of Use cohort who took the product + Participants in Reason for Misuse cohort who completed interview|||Percentage of Participants|||Number
2677859|NCT01427751|Secondary|Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure|Treatment failure was defined as withdrawal of the participant from treatment or from the study by the investigator before the final visit because of a lack of efficacy.|12 Months|Intent-to-treat population included all randomized participants.|||percentage of participants|||Number
2677860|NCT01427751|Secondary|Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)|The VFQ-25 includes 25 vision-targeted questions plus one general health question which assess visual impairment on functioning and specific aspects of health-related quality of life for a total possible composite score of 0 (worst) to 100 (best functionality). A positive change from Baseline indicates improvement.|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.|||score on a scale||Standard Deviation|Mean
2677861|NCT01427751|Secondary|Time to BCVA Improvement of 15-or-More Letters|BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The time in days to BCVA improvement of 15-or-More letters.|12 Months|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.|||days||Standard Deviation|Mean
2677862|NCT01427751|Secondary|Percentage of Patients With a 15-or-More Letter Decrease in BCVA|BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.|||percentage of participants|||Number
2677863|NCT01427751|Secondary|Percentage of Patients With 15-or-More Letter Improvement in BCVA|BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.|||percentage of participants|||Number
2677864|NCT01427751|Secondary|Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at Baseline and Month 12. A negative change from Baseline indicates improvement.|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.|||microns||Standard Deviation|Mean
2678724|NCT01419769|Secondary|Clinical Success|Clinical success is defined as at least a 50% decrease in pseudocyst size, based on radiographic analysis, at 30 days and/or 60 days.|Up to 60 days|Patients treated per protocol.|||percentage of patients|||Number
2677865|NCT01427751|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA)|BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity) A positive change from Baseline (more letters read correctly) indicates improvement.|Baseline, Month 12|Participants from the intent-to-treat population, all randomized participants, with data available for analysis.|||letters||Standard Deviation|Mean
2677866|NCT01427738|Secondary|Number of Participants Who Found GV and Nystatin Acceptable.|Acceptability was defined as the willingness to use the drug if it is proven effective to treat oral candidiasis. Participants were asked whether or not they would be willing to use the assigned treatment via questionnaires.|After 14 days of treatment|The analysis for acceptability of treatment was based on 209 subjects.|||participants|||Number
2677867|NCT01427738|Secondary|Self-Assessment of General Health|Participants rated their general health on two scales. One is a five point scale ranging from 1 to 5 (1=Excellent; 2=Very Good; 3=Good; 4=Fair; 5=Poor)|Weeks 0, 6|N=110 (GV), 110 (Nystatin) wk 0 N= 96 (GV), 95 (Nystatin) wk 6|||participants|||Number
2677868|NCT01427738|Secondary|Number of Participants Who Were Adherent.|Adherence was reported as a dichotomous variable (adherence vs. non-adherence). Participants who have missing doses less than 15% will be considered as adherent, i.e., if a participant is in the GV arm, then the cutoff point is 28*0.15=4 doses; and for the nystatin arm is 56*0.15=8 doses.|After 14 days of treatment|The analysis for adherence was based on 209 observations.|||participants|||Number
2677869|NCT01427738|Secondary|Tolerance|The investigators will measure tolerance using a scale from 0 to 3 (0=No side effects experienced, no changes in treatment; 1=Some side effects experienced, but not enough to modify treatment; 2=Some side effects experienced, resulted in treatment interruption; 3=Side effects experienced, resulted in treatment discontinuation.)|After 14 days of treatment|The analysis for tolerance was based on 208 observations.|||participants|||Number
2677870|NCT01427738|Secondary|Quantitative Yeast Colony Counts|If quantitative yeast culture yielding < 20 CFU/mL of Candida spp., then we call this mycological success|At weeks 0, 2, 6|"At entry, 210 observations were available (182 had positive culture result for Candida specimen, and 175 of those had colony count performed) to evaluate quantitative yeast colony counts.~N= 78 (GV), 70 (Nystatin) at end of treatment; N= 51 (GV), 35 (Nystatin) at week 6;"|||CFU/mL||Standard Deviation|Mean
2677871|NCT01427738|Secondary|Number of Participant With Symptom|Symptoms were assessed using a visual analog scale where the level of discomfort and pain were recorded and quantified using a scoring system from 0 to 3. 0=no discomfort/pain; 1=mild discomfort/pain; 2=Moderate discomfort/pain; 3=Severe discomfort/pain.|after 14 days of treatment|At entry, a total of 217 observations (106 in GV arm; 111 in nystatin arm) were available to evaluate the symptoms (pain and discomfort) associated with OC. At the end of treatment, a total of 204 observations were available to evaluate the symptoms associated with OC using extended Mantel-Haenszel test between GV and nystatin arms.|||participants|||Number
2677872|NCT01427738|Primary|Number of Participants With Clinical Efficacy|The primary endpoint is clinical efficacy defined as cure (absence of lesions) or improvement (a decrease in severity of lesions) after 14 days of treatment. The oral cavity will be split arbitrarily into 6 sites: left lower and upper labial mucosa and buccal mucosa, right lower and upper labial mucosa and buccal mucosa, hard palate, soft palate, tongue (dorsum, lateral, and ventral), and floor of mouth. Severity is scored using a scoring system from 0 to 3 (0 corresponds to absence of lesions, and 3 corresponds to presence of extensive confluent lesions) which leads to a composite severity score ranging from 0 to 18 after adding up the scores from all 6 sites. Complete success is assigned if the composite score after treatment equals to 0. Improved/partial response is assigned if the composite score after treatment is less than the baseline score. The blinded evaluator scores the severity of lesions by examining different lesion characteristics.|After 14 days of treatment|Out of 221 subjects,17 had oral exams at entry but not week 2: 11 premature discontinuation, 2 missed visits, and 4 without specific reasons. 204 subjects received oral exams at both entry and week 2. 2 more participants were excluded from the final analysis because they had no pseudomem candi at entry, which led to a total of 202 subjects.|||participants|||Number
2677873|NCT01427608|Secondary|Changes in Metabolic Measures: Triglycerides|Change in triglycerides from entry into randomized phase (baseline) and 36 weeks.|From entry into randomized phase (baseline) and 36 weeks||||mg/dL||95% Confidence Interval|Mean
2677874|NCT01427608|Secondary|Changes in Metabolic Measure: Cholesterol|Change in cholesterol from entry into randomized phase (baseline) and 36 weeks.|From entry into randomized phase (baseline) and 36 weeks||||mg/dL||95% Confidence Interval|Mean
2677875|NCT01427608|Secondary|Changes in Metabolic Measures: Weight|Change in weight from entry into randomized phase (baseline) and 36 weeks.|From entry into randomized phase (baseline) and 36 weeks||||pounds||95% Confidence Interval|Mean
2677876|NCT01427608|Primary|Number of Subjects at Risk of Relapse During the Randomized Phase.|"Relapse criteria include at least one of the following:~1)Structured Clinical Interview for Diagnostic Statistical Manual #4 Trade Revision (DSM-IV-TR) Axis 1 Disorders (SCID) symptoms of major depression maintained over two weeks 2)17-item Hamilton Depression Rating Scale score of >17 maintained for more than one week + a mean increase of 5 points from entry into randomized phase 3)Re-emergence of psychosis for more than one week, with a SADS (Schedule for Affective Disorders and Schizophrenia) score of >2 on delusion or hallucination severity items 4)Significant clinical worsening defined as either emergence of high-risk of suicide, and/or development of mania for greater than one week, and/or psychiatric hospitalization."|From entry into randomized phase (baseline) and 36 weeks or earlier relapse||||Participants|||Count of Participants
2677877|NCT01427517|Primary|Brain GSH|change in brain GSH levels from baseline to post-NAC administration (90 - 110 minutes) in all subjects|Baseline and up to 110 minutes post-NAC administration||||percent increase from baseline||Standard Deviation|Mean
2677878|NCT01427504|Primary|Etravirine Cmin Pharmacokinetics Coadministered With Boceprevir|Determine etravirine Cmin when coadministered with boceprevir. [Ratio = etravirine administered with boceprevir / etravirine administered alone]|Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||Ratio||90% Confidence Interval|Geometric Mean
2713964|NCT01145066|Primary|hsCRP|Changes in high sensitive C-reactive protein (hsCRP) were assessed.|baseline||||mg/L||Standard Deviation|Mean
2677879|NCT01427504|Primary|Etravirine Cmax Pharmacokinetics Coadministered With Boceprevir|Determine etravirine Cmax when coadministered with boceprevir. [Ratio = etravirine administered with boceprevir / etravirine administered alone]|Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post-dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||Ratio||90% Confidence Interval|Geometric Mean
2677880|NCT01427504|Primary|Etravirine AUC Pharmacokinetics Coadministered With Boceprevir|Determine etravirine AUC when coadministered with boceprevir. [Ratio = Etravirine administered with bocepreivr / etravirine administered alone]|Pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours Post-dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||Ratio||90% Confidence Interval|Geometric Mean
2677881|NCT01427504|Primary|Boceprevir C8 Pharmacokinetics Coadministered With Etravirine|Determine boceprevir 8 hour concentration when coadministered with etravirine. [Ratio = boceprevir administered with etravirine / boceprevir administered alone]|Pre-dose, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||Ratio||90% Confidence Interval|Geometric Mean
2677882|NCT01427504|Primary|Boceprevir Cmax Pharmacokinetics Coadministered With Etravirine|Determine boceprevir Cmax when coadministered with etravirine. [Ratio = boceprevir administered with etravirine / boceprevir alone]|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||Ratio||90% Confidence Interval|Geometric Mean
2677883|NCT01427504|Primary|Boceprevir AUC Pharmacokinetics Coadministered With Etravirine|Determine boceprevir AUC when coadministered with etravirine. [Ratio = boceprevir administered with etravirine/ boceprevir alone]|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||Ratio||90% Confidence Interval|Geometric Mean
2677884|NCT01427504|Primary|Etravirine Cmin Pharmacokinetics|Determine etravirine Cmin when administered alone|Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2677885|NCT01427504|Primary|Etravirine Cmax Pharmacokinetics|Determine etravirine Cmax when administered alone|Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2677886|NCT01427504|Primary|Etravirine AUC Pharmacokinetics|Determine etravirine area under the concentration vs. time curve (AUC)when administered alone.|Pre-dose and, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2677887|NCT01427504|Primary|Boceprevir C8 Pharmacokinetics|Determine boceprevir 8 hour concentration when administered alone.|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2677888|NCT01427504|Primary|Boceprevir Cmax Pharmacokinetics|Determine the Cmax of boceprevir when administered alone.|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants is based on the number of subjects that completed all three sequences of medication.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2677889|NCT01427504|Primary|Boceprevir AUC Pharmacokinetics|Determine boceprevir area-under-the concentration time curve (AUC) when administered alone.|Pre-dose and, 1, 2, 3, 4, 5, 6, and 8 hours post dose on day 11-14|The number of participants was based on the number of subjects that completed all three sequences of medication.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2677890|NCT01427309|Other Pre-specified|Safety Overview After Injection With Either Fluzone High Dose or Fluzone Vaccine Through the End of Surveillance Period|All serious adverse events, including deaths and adverse events (AEs) of special interest (Guillain Barre Syndrome, Bell's Palsy, encephalitis/myelitis, optic neuritis, Stevens Johnson Syndrome, and toxic epidermal necrolysis) were collected.|Day 0 up to Day 240 post-vaccination|Safety was assessed in the Full Analysis Set.|||Participants|||Number
2677891|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Respiratory Illness|"Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific (i.e., for Influenza A and Influenza B) antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture).~Respiratory illness is defined as the occurrence of a new onset (or exacerbation of a pre-existing condition/symptom) of one or more of the following symptoms (that persist for or reoccur after a period of at least 12 hours): sneezing, stuffy or runny nose (nasal congestion), sore throat, cough, sputum production, wheezing, or difficulty breathing."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by any influenza viral types/subtypes, in association with a respiratory illness were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2677906|NCT01426789|Secondary|Percentage of Participants Who Achieve ACR50 and ACR70 With the Presence/Absence of the HLA-DRB1*04 Allelic Group|A participant was considered to be a responder according to the ACR50 or ACR70 criteria if the participant had at least 50% or 70% improvement, respectively, in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).|12 weeks|Participants, who completed part 1, were included in the analysis.|||Percentage of participants|||Number
2677933|NCT01426438|Secondary|Women: Change in HDL Cholesterol|Among women, change in HDL cholesterol (mg/dL) from week 0 to week 24.|0 and 24 weeks|Women in the as-treated analysis population, limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||mg/dL||Inter-Quartile Range|Median
2678725|NCT01419769|Secondary|Effectiveness: Technical Success|Placement of the AXIOS Stent using the AXIOS Delivery System and removal of the AXIOS Stent using a standard endoscopic snare.|Up to 60 days|Intent-to-Treat population|||participants|||Number
2677892|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Respiratory Illness|"Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.~Respiratory illness was defined as the occurrence of a new onset (or exacerbation of a pre-existing condition/symptom) of one or more of the following symptoms (that persist for or reoccur after a period of at least 12 hours): sneezing, stuffy or runny nose (nasal congestion), sore throat, cough, sputum production, wheezing, or difficulty breathing."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by influenza viral types/subtypes that are antigenically similar to those contained in the vaccine formulations, in association with a respiratory illness were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2677893|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Modified CDC-defined Influenza-like Illness|"Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.~The modified Centers for Disease Control and Prevention-defined influenza-like illness is the occurrence of fever (defined as temperature > 99.0°F [> 37.2°C]) with cough or sore throat."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by any influenza viral types/subtypes, in association with a modified CDC-defined influenza-like illness were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2677894|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Modified CDC-defined Influenza-like Illness.|"Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.~The modified Centers for Disease Control and Prevention-defined influenza-like illness is the occurrence of fever (defined as temperature > 99.0°F [> 37.2°C]) with cough or sore throat."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by influenza viral types/subtypes that are antigenically similar to those contained in the vaccine formulations, in association with a modified CDC-defined influenza-like illness were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2677895|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness|"For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney [MDCK] cells, Classic Flu A and B culture using Rhesus Monkey Kidney [RhMK] cells, and R Mix Flu A and B culture).~A protocol-defined influenza-like illness (ILI) was determined by the occurrence of at least one of the following respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing; concurrently with at least one of the following systemic symptoms: fever (defined as temperature > 99.0°F [> 37.2°C]), chills (shivering), tiredness (fatigue), headache, or myalgia (muscle aches)."|≥14 days post-vaccination|Occurrences of culture-confirmed influenza caused by any influenza viral types/subtypes, in association with a protocol-defined influenza-like illness was assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2677896|NCT01427309|Secondary|Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Protocol-defined Influenza-like Illness (ILI)|Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific (i.e., for Influenza A and Influenza B) antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney [MDCK] cells, Classic Flu A and B culture using Rhesus Monkey Kidney [RhMK] cells, and R Mix Flu A and B culture. For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.|≥14 days post-vaccination|Clinical efficacy was assessed in subjects who met all eligibility criteria, received the vaccine they were randomized to, had successful surveillance contact, did not received additional influenza vaccinations and did not have protocol deviations likely to impact their responses for the primary and secondary endpoints (Per-protocol analysis set).|||Participants|||Number
2677907|NCT01426789|Primary|Change From Baseline in Disease Activity Score 28 (DAS28) in Association With the Presence or Absence of HLA-DRB1 04|The DAS28 is a measure of disease activity in RA. The score is calculated by a complex mathematical formula, which includes the tender joint count(TJC) and swollen joint count (SJC) out of a total of 28 joints, the high-sensitivity C-reactive protein (hsCRP), and the subject's 'global assessment' of disease activity/general health (GH). The subject's global assessment/GH was indicated by a visual analogue scale of 100 mm where the participant marked a point on a 100 mm line between 0 and 100 (0 indicated very good and 100 indicated very bad). The following formula was used to calculate DAS28: DAS-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) = 0.36*ln(CRP+1) + 0.014*GH = 0.96. A DAS28-CRP score > 5.1 implies active disease, <3.2 implies controlled disease and <2.6 implied remission. A negative change from baseline indicates improvement.|baseline, 12 weeks|Participants, who completed part 1, were included in the analysis.|||score on a scale||Standard Error|Least Squares Mean
2677934|NCT01426438|Secondary|Men: Change in HDL Cholesterol|Among men, change in HDL Cholesterol (mg/dL) from week 0 to week 24.|0 and 24 weeks|Men in the as-treated analysis population, limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||mg/dL||Inter-Quartile Range|Median
2677897|NCT01427309|Primary|Occurrences of Culture- or Polymerase Chain Reaction (PCR)-Confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness (ILI).|"Influenza positive cultures were confirmed using direct immunofluorescence techniques with influenza type-specific antibodies. 3 culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). The initial molecular test (PCR) was the validated ProFlu+™ assay by Prodesse, Inc., Waukesha, WI, which had been approved by the Food and Drug Administration through a 510K evaluation for specific detection of Influenza A, B or Respiratory Syncytial Virus.~A protocol-defined influenza-like illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing; concurrently with at least one of the following systemic symptoms: fever (defined as temperature > 99.0°F [> 37.2°C]), chills (shivering), tiredness (fatigue), headache, or myalgia (muscle aches)."|≥14 days post-vaccination|Clinical efficacy was assessed in subjects who met all eligibility criteria, received the vaccine they were randomized to, had successful surveillance contact, did not received additional influenza vaccinations and did not have protocol deviations likely to impact their responses for the primary and secondary endpoints (Per-protocol analysis set).|||Participants|||Number
2677898|NCT01427296|Primary|Distribution of the Overall Colon-cleansing Scale in Each Treatment Group.||6 months||||Participants|||Count of Participants
2677899|NCT01426958|Primary|Area Under Curve From 0 to ∞ Hours (AUC0-∞)|AUC0-∞ represents the area under the concentration curve of the analyte in plasma from 0 extrapolated to infinity.|0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post|This subject set includes all evaluable subjects of the treated set who were assigned to the final dose groups and who provide at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2677900|NCT01426958|Primary|Maximum Concentration (Cmax)|Cmax represents the maximum concentration of the analyte in plasma.|0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post|This subject set includes all evaluable subjects of the treated set who were assigned to the final dose groups and who provide at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2677901|NCT01426958|Primary|Area Under Curve From 0 to tz (AUC0-tz)|AUC0-tz represents the area under the concentration curve of the analyte in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte.|0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post|This subject set includes all evaluable subjects of the treated set who were assigned to the final dose groups and who provide at least one observation for at least one primary (PK) endpoint without important protocol violations relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2677902|NCT01426867|Primary|Mean Ocular Discomfort Score|Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe).|Week 1|Intent-to-Treat (ITT): All subjects who received study medication and had at least 1 scheduled on-therapy visit.|||Units on a scale||Standard Deviation|Mean
2677903|NCT01426854|Secondary|Proportion of Subjects Who Were Pain-Free at All Postoperative Visits|Ocular pain is defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The Investigator scored ocular pain based on the description of pain by the subject. Pain was scored on a 6-unit scale ranging from 0 (none, absence of positive sensation) to 5 (severe, subject reports intense ocular, periocular or radiating pain requiring prescription analgesic). To be considered pain-free at all post operative visits, the patient must have had a score of 0 at Days 1, 3, 7, and 14 and any unscheduled visit. The proportion of subjects who were pain-free at all post-operative visits is reported as percentage.|Up to Day 14|Intent-to-treat: All randomized subjects who completed cataract/IOL implant surgery and returned for at least one postoperative primary efficacy assessment.|||Percentage of subjects|||Number
2677904|NCT01426854|Primary|Proportion of Subjects With Clinical Cure at Day 14|Ocular inflammation was assessed by the Investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (>30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare. The proportion of subjects with a clinical cure is reported as percentage.|Day 14 postoperative|Intent-to-treat: All randomized subjects who completed cataract/IOL implant surgery and returned for at least one postoperative primary efficacy assessment.|||Percentage of subjects|||Number
2677905|NCT01426789|Secondary|Change From Baseline in DAS28 in Association With the Presence or Absence of HLA-DRB1 *SE (Positive), HLA-DRB1 *401 (Carrier) and HLA-DRB1 Position 11 V/L and in Association With Other Biomarkers|The DAS28 is a measure of disease activity in RA. The score is calculated by a complex mathematical formula, which includes the tender joint count(TJC) and swollen joint count (SJC) out of a total of 28 joints, the high-sensitivity C-reactive protein (hsCRP), and the subject's 'global assessment' of disease activity/general health (GH). The subject's global assessment/GH was indicated by a visual analogue scale of 100 mm where the participant marked a point on a 100 mm line between 0 and 100 (0 indicated very good and 100 indicated very bad). The following formula was used to calculate DAS28: DAS-CRP = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) = 0.36*ln(CRP+1) + 0.014*GH = 0.96. A DAS28-CRP score > 5.1 implies active disease, <3.2 implies controlled disease and <2.6 implied remission. A negative change from baseline indicates improvement.|baseline, 12 weeks|Participants, who completed part 1, were included in the analysis. Statistical analysis was not done on the other biomarkers: osteoprotegerin (OPG), rheumatoid factor (RF), anti-cyclic citrullinated peptide antibodies (CCP) and hsCRP. Therefore, data is provided for the alleles only.|||score on a scale||Standard Error|Least Squares Mean
2677925|NCT01426438|Secondary|Change in C-reactive Protein (CRP)|Change in C-reactive protein from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||ug/ml||Inter-Quartile Range|Median
2677926|NCT01426438|Secondary|Change in IL-6|Change in IL-6 from week 0 to week 24|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||pg/ml||Inter-Quartile Range|Median
2677908|NCT01426789|Primary|Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20 ) in Association With the Presence or Absence of the HLA-DRB1 *4 Allelic Group|A participant was considered to be a responder according to the ACR20 criteria if the participant had at least 20% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).|12 weeks|Participants, who completed part 1, were included in the analysis.|||Percentage of participants|||Number
2677909|NCT01426763|Secondary|Number of Subjects With C1 INH Antibodies||Through 30 days after final dose|||||||
2677910|NCT01426763|Secondary|C1 Inhibitor (C1 INH) and C4 Levels||18 days|||||||
2677911|NCT01426763|Primary|Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study||18 days||||participants|||Number
2677912|NCT01426581|Secondary|Number of Participants With Acute Care Events 30 Days Post Discharge|Exacerbation/acute care events within one month of hospital discharge|1 month|The discrepancy between the number of participants analyzed in each group and the number of participants in each arm total is due to lost to follow-up. In the Teach to Goal arm, 8 participants were lost to follow up and 5 participants were lost to follow up in the Brief Intervention arm.|||Participants|||Count of Participants
2677913|NCT01426581|Secondary|Symptom Control|Symptom control will be assessed using interviewer-administered surveys. Using the Borg Dyspnea Scale, a validated Scale from 0 - 20 where 20 is maximal dyspnea, we took the difference between the the 30 day follow-up self reported shortness of breath from baseline to see if there was improvement in symptom control.|1 month|The discrepancy from the number of participants in each group and the number of participants analyzed is due to missing data values due to lose to follow-up for the 30-day post discharge visit. 8 participants did not have values in the Teach To Goal group and 5 did not for the Brief Intervention group.|||units on a scale||Standard Deviation|Mean
2677914|NCT01426581|Secondary|Number of Participants With Self-Efficacy|This is a self-reported measure of how confident a participant is on how well they use their metered dose inhaler.|1 month||||Participants|||Count of Participants
2677915|NCT01426581|Secondary|Role of Health Literacy - Number of Less-Than-Adequate Health Literacy Participants With 30 Days Post Discharge Acute-Care Events|To determine the relative effectiveness of TTG compared to BI for patients with less-than-adequate health literacy using self-reported acute-care events 30 days post discharge. To measure less-than-adequate health literacy, the investigators administered the Short Test of Functional Health Literacy in Adults, a validated tool to assess whether a participant has adequate, marginal, or inadequate health literacy. Less-than-adequate included marginal and inadequate health literacy.|1 month|Out of 120 participants, 23 were screened to have less-than-adequate health literacy.|||Participants|||Count of Participants
2677916|NCT01426581|Primary|Percentage of Participants With MDI Misuse From Baseline to 30 Days Post-Discharge|To evaluate the relative effectiveness of hospital-based TTG versus BI on patients' ability to retain instruction about the correct use of MDI Devices one month after discharge home.|1 month||||percentage|||Number
2677917|NCT01426555|Secondary|Validation of DXA Scanning in Patients With SCI|This study has been designed to evaluate whether sequential DXA scanning of the distal femur and proximal femur is an appropriate clinical tool to monitor bone changes in response to either treatment. Evaluation of bone density by DXA was planned to be compared to CT scans of the distal femur and proximal tibia.|12 months|Dataset unavailable for analysis to VABHS study team. The study was closed by the VABHS IRB.||||||
2677918|NCT01426555|Primary|Improvement of Bone Mass as Measured by Sequential Evaluation of Bone Density and Bone Structure|This work was designed to determine if FES-rowing plus Zoledronic acid is superior to FES-rowing alone reversing deterioration and weakening of the bones due to SCI and was planned to confirm the effects of FES-rowing in bone structure in patients not receiving Zoledronic Acid.|12 months|Data was never analyzed because the study was closed by the VABHS IRB. Full dataset is unavailable for analysis.||||||
2677919|NCT01426516|Secondary|Acceptability of the Use of AGT for Subjects and Clinicians as Measured by Satisfaction Survey|To determine the acceptability to patients and clinicians of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder|6 months|||||||
2677920|NCT01426516|Secondary|Cost|To compare costs of AGT versus TAU in outpatient treatment of nonpsychotic major depressive disorder as measured by claims data.|6 months|||||||
2677921|NCT01426516|Secondary|Quality of Life as Measured by Self Reported Assessment of Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)|To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder, in terms of patient quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)) The minimum raw score on the QLESQ is 14, and the maximum score is 70.|baseline, 3, 6 months|||||||
2677922|NCT01426516|Secondary|Clinician Behavior as Measured by Change in Recorded Treatment Choice Before and After the Assay Results Are Made Available.|Clinicians will rank first and alternative treatment choice and dosage prior to assay and first and two alternative treatment choices after receiving assay results (for AGT group). Clinician choices will be compared.|one week|||||||
2677923|NCT01426516|Primary|Efficacy Measured by Change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), Adjusted for Baseline Severity, at 6 Months|"To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU), in terms of depression severity as measured by change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), adjusted for baseline severity, at 6 months~Add:~highest score on any 1 of the 4 sleep items (items 1 to 4)~highest score on any 1 of the 4 weight items (items 6 to 9)~highest score on either of the 2 psychomotor items (15 and 16)~scores for each of the 6 MDD symptom domains~Total scores range from 0-27. 0 = no signs of depression; 27 = severe depression"|6 months|Invalid Data Collection||||||
2677924|NCT01426438|Secondary|Change in D-Dimer|Change in D-Dimer from week 0 to week 24|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||ug/ml||Inter-Quartile Range|Median
2713965|NCT01145066|Primary|Fasting Insulin|Fasting insulin data at 4 and 8 weeks was averaged.|4 weeks and 8 weeks combined||||μIU/mL||Standard Deviation|Mean
2677936|NCT01426438|Secondary|Change in Cholesterol|Absolute change in total cholesterol from week 0 to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan and had lipid panels at weeks 0 and 24.|||mg/dL||Inter-Quartile Range|Median
2677937|NCT01426438|Primary|Absolute Change in Relative FMD (%)|The absolute change in maximum relative flow mediated dilation (FMD) (%) of the brachial artery from baseline to week 24.|0 and 24 weeks|This is an as-treated analysis limited to 74 participants who had 24 weeks of follow up and a useable week 24 scan.|||% FMD||Inter-Quartile Range|Median
2677938|NCT01426425|Secondary|Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT in Subjects Who Achieved Acute Procedural Success.|If there was no documented evidence of AVNRT recurrence in the post-procedure 6-month follow-up period, the subject is counted as a chronic effectiveness success. The AE Adjudication Committee adjudication of AVNRT recurrence is used to classify subjects for this endpoint.|6 Months|The 378 mITT subjects who had acute procedural success with cryoablation for the treatment of AVNRT are included in this analysis.|||Participants|||Count of Participants
2677939|NCT01426425|Primary|Chronic Safety (Through 6 Months) of the Freezor Xtra Catheter When Used for the Treatment of AVNRT Using an Endocardial Approach.|Subjects who had at least one safety event during or after their cryoablation procedure or through 6 months of follow-up are considered a primary (chronic) safety failure. A safety event is defined as the occurrence of any adverse event that is adjudicated by the AE Adjudication Committee as being serious and study ablation procedure-related and/or Freezor Xtra Catheter related that: 1) Resulted in death, 2) Resulted in a life-threatening illness or injury, 3) Resulted in permanent impairment of a body function or permanent damage to a body structure, 4) Necessitated significant intervention, such as major surgery or even intravenous medical therapy (e.g., vasopressors), to prevent permanent impairment of a body function or permanent damage to a body structure, or 5) Required in-patient hospitalization or a prolongation of an existing hospital stay.|6 Months|The modified intent-to-treat (mITT) set consists of subjects who signed the ICY-AVNRT consent form and met all Pre-EP and Post-EP study inclusion and no exclusion criteria who had a Freezor Xtra Cardiac Cryoablation Catheter inserted into the vasculature for the purpose of the ICY-AVNRT study.|||Participants|||Count of Participants
2677940|NCT01426425|Primary|Chronic Effectiveness (Through 6 Months) of the Freezor Xtra Catheter for the Treatment of AVNRT Using an Endocardial Approach.|"Subjects must have met both of the following acute and chronic conditions to be considered a chronic effectiveness (treatment) success:~Acute Success: The inability to induce more than one echo beat by the same pacing maneuvers that induced AVNRT before cryoablation (with drug provocation if required for induction before cryoablation) at the conclusion of the study cryoablation procedure assessment.~Chronic Success: Lack of documented recurrence of clinical AVNRT during the 6-month follow-up period after the study cryoablation procedure."|6 months|The modified intent-to-treat (mITT) set consists of subjects who signed the ICY-AVNRT consent form and met all Pre-EP and Post-EP study inclusion and no exclusion criteria who had a Freezor Xtra Cardiac Cryoablation Catheter inserted into the vasculature for the purpose of the ICY-AVNRT study.|||Participants|||Count of Participants
2677941|NCT01426412|Secondary|Number of Participants With Detectable Levels of Anti-LY3015014 Antibodies||Days 8, 29 and 85|All randomized participants.|||Participants|||Count of Participants
2677942|NCT01426412|Secondary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C)|Least Square means were calculated using mixed-effects models for repeated measures analysis. The model included factors for treatment, visits and baseline LDL-C. Percent change = (LDL value on Days 15 or 29 - LDL at baseline) / LDL at baseline *100.|Baseline, Days 15 and 29|All randomized participants with evaluable LDL-C data at specified time points.|||percentage of change||90% Confidence Interval|Least Squares Mean
2677943|NCT01426412|Secondary|PK: Maximum Concentration (Cmax) of LY3015014||Predose, 0, 1, 2, 4, 12, 24 hours post dose, and 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85, 99, 113, 127 and 155 days post-dose|All randomized participants who received LY3015014 and had PK data to calculate Cmax.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2677944|NCT01426412|Secondary|Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time 0 to the Last Time Point With a Measurable Concentration of LY3015014 [AUC(0-tlast)]||Predose, 0, 1, 2, 4, 12, 24 hours post dose, and 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85, 99, 113, 127 and 155 days post-dose|All randomized participants who received LY3015014 and had PK data to calculate AUC(0-tlast).|||micrograms *hour/milliliter (µg*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2677945|NCT01426412|Primary|Number of Participants With Clinically Significant Effects|Adverse events (AEs) were considered as clinically significant effects. A summary of serious AEs (SAEs) and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline to study completion (up to 22 weeks)|All randomized participants.|||Participants|||Count of Participants
2677946|NCT01426386|Secondary|Frequency and Intensity of Adverse Events||From signing informed consent form until end of trial visit (up to 5 months)|Safety population (all randomised and exposed subjects). This is equivalent to the mITT|||participants|||Number
2677947|NCT01426386|Secondary|Clinical Pregnancy With Fetal Heart Beat Rate|Clinical pregnancy with fetal heart beat was defined as at least one intrauterine gestational sac with fetal heart beat|5-6 weeks after transfer|mITT population (all randomised and exposed subjects). This is equivalent to the FAS|||percentage||95% Confidence Interval|Number
2677948|NCT01426386|Secondary|Number and Quality of Blastocysts on Day 5|Number of blastocysts (total and good-quality) on Day 5 are presented. A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher|Day 5 after oocyte retrieval|Subjects with oocytes retrieved|||Blastocysts||Standard Deviation|Mean
2677949|NCT01426386|Secondary|Number of Fertilised Oocytes|An oocyte with 2 pronuclei was regarded as correctly fertilised|Day 1 after insemination|Subjects with oocytes retrieved|||Fertilised oocytes||Standard Deviation|Mean
2677950|NCT01426386|Secondary|Total IMP Dose||End of stimulation (up to 16 stimulation days)|mITT population (all randomised and exposed subjects). This is equivalent to the FAS|||µg||Standard Deviation|Mean
2677951|NCT01426386|Secondary|Endocrine Profile|Estradiol at end of stimulation|End of stimulation (up to 16 stimulation days)|mITT population (all randomised and exposed subjects). This is equivalent to the FAS|||pmol/L||Standard Deviation|Mean
2713966|NCT01145066|Primary|Fasting Insulin||baseline||||μIU/mL||Standard Deviation|Mean
2677953|NCT01426386|Primary|Number of Oocytes Retrieved||Day of oocyte retrieval (up to Day 18 after start of stimulation)|Modified Intention-to-treat (mITT) population (all randomised and exposed subjects). This is equivalent to the Full Analysis Set (FAS)|||Oocytes||Standard Deviation|Mean
2677954|NCT01426373|Secondary|Change From Baseline in Line Drawing Assessment|Each participant was given 2 example line drawings representing each of the 5 submental fat grades (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme) and asked to select the drawing that best represents their current profile. Improvement is any decrease in grade, and worsening is any increase in grade.|Baseline and month 3 after last treatment|Treatment effect population with available data|||participants|||Number
2677955|NCT01426373|Secondary|Change From Baseline in Submental Skin Laxity Grade (SMSLG)|"SMSLG assessment was based on clinical evaluation and palpation of the submental area. The SMSLG scale incorporates 3 features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds).~Grade 1 (none): no or minimal superficial wrinkling, skin well apposed to deeper neck structures, no skin redundancy (no skin draping (vertical folds) or skin sagging (horizontal folds));~Grade 2 (mild): mild superficial wrinkling, skin well apposed to deeper neck structures, minimal skin redundancy (slight skin draping and sagging);~Grade 3 (moderate): may have mild to moderate superficial wrinkling, skin has mild to moderate separation from deeper neck structures, moderate skin redundancy (moderate skin draping and skin sagging);~Grade 4 (severe): mild to marked superficial wrinkling, loose skin separated from deeper neck structures, marked skin redundancy (marked skin draping and sagging)."|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data (indicated by n)"|||units on a scale||Standard Deviation|Mean
2677956|NCT01426373|Secondary|Percent Change From Baseline in Submental Fat Thickness|Submental fat thickness was measured using calipers.|Baseline and month 3 and month 12 after last treatment|Treatment effect population with available data at baseline (164) and at each time point|||percent change||Standard Deviation|Mean
2677957|NCT01426373|Secondary|Response to Subject Global Questions|"Participants answered 3 questions on a 7-point scale that ranged from a great deal worse to a great deal better (questions 1 and 2) or from extremely dissatisfied to extremely satisfied (question 3).~Question 1: Since the start of the study, how would you rate the fat under your chin right now?~Question 2: Since the start of the study, how would you rate the definition between your chin and neck right now?~Question 3: How satisfied are you with the treatment you received in this study?"|Month 3 and month 12 after last treatment|Treatment effect population with available data at each time point|||participants|||Number
2677958|NCT01426373|Secondary|Mean Change From Baseline in Self-rating of Attractiveness|"Self-rating of Attractiveness assesses aspects of appearance from the participant's perspective with a series of 6 questions: How attractive do you think your overall appearance (chin/neck, eyes, nose, mouth, entire face) is/are? Each question was answered on a scale from 1 to 9 (1 = not at all attractive, 5 = neither attractive nor unattractive, and 9 = extremely attractive). A positive change from baseline indicates improvement."|Baseline and month 3 and month 12 after last treatment|Treatment effect population with available data at baseline (163), month 3 (144), and month 12 (130)|||units on a scale||Standard Deviation|Mean
2677959|NCT01426373|Secondary|Mean Change From Baseline in Subject Self Rating Scale (SSRS)|The SSRS assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 (0 = extremely dissatisfied, 1 = dissatisfied, 2 = slightly dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = slightly satisfied, 5 = satisfied and 6 = extremely satisfied). A positive change from baseline indicates improvement.|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data (indicated by n)"|||units on a scale||Standard Deviation|Mean
2677960|NCT01426373|Secondary|Mean Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)|The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) related to the appearance of submental fullness as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from baseline indicates improvement.|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data at baseline and each time point (indicated by n)"|||units on a scale||Standard Deviation|Mean
2677961|NCT01426373|Secondary|Percentage of Participants Who Achieved a Composite 2-grade Response|"A composite 2-grade response is defined as at least a 2-grade improvement from baseline on both the CR-SMFRS and PR-SMFRS.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme).~The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? and answered on a 5-point ordinal scale (0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat)."|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data at baseline and at each time point (indicated by n)"|||percentage of participants|||Number
2677962|NCT01426373|Secondary|Percentage of Participants Who Achieved a Composite 1-grade Response|"A composite 1-grade response is defined as at least a 1-grade improvement from baseline on both the CR-SMFRS and PR-SMFRS.~The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme).~The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? and answered on a 5-point ordinal scale (0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat)."|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data at baseline and at each time point (indicated by n)"|||percentage of participants|||Number
2677989|NCT01426009|Secondary|Peak FEV1 (Maximum FEV1 During the First 4 Hours Post-dose on Day 1 and Day 7)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines|Day 1 and Day 7|All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 trough FEV1 values were included in the modified intent-to-treat (mITT) analysis set|||liters||Standard Deviation|Mean
2677963|NCT01426373|Secondary|Mean Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS)|"The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? and answered on a 5-point ordinal scale (0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat). A negative change from baseline indicates improvement."|Baseline and month 3 and month 12 after last treatment|"Treatment effect population with available data at baseline (163) and at each time point (indicated by n)"|||units on a scale||Standard Deviation|Mean
2677964|NCT01426373|Secondary|Mean Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores (CR-SMFRS)|The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme). A negative change from baseline indicates improvement.|Baseline and months 3, 6, 9, and 12 after last treatment|"Treatment effect population (all participants who received at least 1 injection with study drug and had any posttreatment data for treatment effect variables or for the submental skin laxity grade) and with available data at each time point (indicated by n)."|||units on a scale||Standard Deviation|Mean
2677965|NCT01426373|Primary|Number of Participants With Adverse Events (AEs)|"Serious AEs include any event that met one or more of the following criteria: was fatal or life-threatening, required inpatient hospitalization or prolonged a hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or a significant medical hazard.~The severity of each AE was defined as either:~Mild: The participant was aware of the sign or symptom, but it was easily tolerated.~Moderate: The sign or symptom caused discomfort and interfered with usual activity.~Severe: The sign or symptom was incapacitating, and the participant was unable to engage in usual activity.~The investigator determined the relationship of each AE to the study drug using the question: Is there a reasonable possibility that the event may have been caused by treatment with the study drug?"|Up to 12 months after last treatment (maximum of 18 months from first treatment)|Safety population|||participants|||Number
2677966|NCT01426360|Primary|Air Blast Hypersensitivity Score 3 Days After Dentifrice Use|"After 3 days, tooth was isolated. Air was delivered from a standard dental unit air syringe and directed at exposed buccal surface of the hypersensitive tooth for 1 second. The Schiff Cold Air Sensitivity Scale was used to assess the subjects' response.~0 - Subject does not respond to air stimulus;~- Subject responds to air stimulus, but does not request discontinuation of stimulus;~- Subject responds to air stimulus and requests discontinuation or moves from stimulus;~- Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus."|3 days after dentifrice use||||scale||Standard Deviation|Mean
2677967|NCT01426360|Primary|Tactile Hypersensitivity Score After 3 Days of Dentifrice Use|After 3 days, tactile hypersensitivity assessments were done using an Electronic Force Sensing Probe (Yeaple Probe Model 200A, Xinix Research Inc., USA). Scores were recorded in terms of a quantified, reproducible force applied by a #19 explorer tip. After presetting the probe to 10 grams, the tip of the probe was run across the exposed dentin perpendicular to the examined surface. Subsequent passes were made, each time the applied force was increased by 10 grams, until the subject indicated that he/she was experiencing discomfort, or until the maximum force of 50 grams had been reached.|3 days after dentifrice use||||gram||Standard Deviation|Mean
2677968|NCT01426360|Primary|Air Blast Hypersensitivity Scores Immediately After Topical Dentifrice Use|"The tooth was isolated. Air was delivered from a standard dental unit air syringe and directed at the exposed buccal surface of the hypersensitive tooth for 1 second. The Schiff Cold Air Sensitivity Scale was used to assess the subjects' response.~0 - Subject does not respond to air stimulus;~- Subject responds to air stimulus, but does not request discontinuation of stimulus;~- Subject responds to air stimulus and requests discontinuation or moves from stimulus;~- Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus."|immediately after dentifrice use||||scale||Standard Deviation|Mean
2677969|NCT01426360|Primary|Tactile Hypersensitivity Scores Immediately After Topical Dentifrice Use|Immediately after dentifice use, tactile hypersensitivity assessments were done using an Electronic Force Sensing Probe (Yeaple Probe Model 200A, Xinix Research Inc., USA). Scores were recorded in terms of a quantified force applied by a #19 explorer tip. After presetting the probe to 10 grams, the tip of the probe was run across the exposed dentin perpendicular to the examined surface. Subsequent passes were made, each time the applied force was increased by 10 grams, until the subject indicated that he/she was experiencing discomfort, or until the maximum force of 50 grams had been reached.|immediately after dentifrice use||||gram||Standard Deviation|Mean
2677970|NCT01426347|Secondary|Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF)|In each dimension and component of AIMS2-SF, item scores are from 0 to 10 with 10 being worst health.|Baseline and 16 weeks (end of RCT)|For placebo, analysis is based on 26 at baseline and 33 at the end of RCT For treatment, analysis is based on 27 at baseline and 38 at the end of RCT|||units on a scale||Standard Deviation|Mean
2677971|NCT01426347|Primary|Disease Activity Score (DAS) 28|"We measured disease activity as measured by DAS 28 at baseline and at the completion of Randomized Controlled trial, both in the placebo and the active treatment group.~We used DAS-28 scores to indicate disease activity. The DAS -28 scale has a minimum of 0 and a maximum of 10, with higher numbers indicating higher disease activity.~We used the following cut-offs: Remission (< 2.6), low disease activity (< 3.2), moderate disease activity (< 5.1) and high disease activity (> 5.1)."|Baseline and 16 weeks (end of Randomized Controlled Trial (RCT))||||composite score||Standard Deviation|Mean
2677972|NCT01426269|Other Pre-specified|Period 1: Tolerability (Dryness)|Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.|Period 1 (12 Weeks)||||participants|||Number
2677973|NCT01426269|Other Pre-specified|Period 1: Tolerability (Stinging/Burning)|Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.|Period 1 (12 Weeks)||||participants|||Number
2677974|NCT01426269|Other Pre-specified|Period 1: Tolerability (Scaling)|Scaling, dryness, and stinging/burning were graded at baseline and weeks 4, 8, and 12 for subjects taking oral doxycycline and topical metronidazole.|Period 1 (12 Weeks)||||participants|||Number
2677975|NCT01426269|Secondary|Period 2: Inflammatory Lesion Count|The evaluator (investigator or a designee) performed lesion counts at each postbaseline visit.|Period 2 (40 Weeks)||||lesions||Standard Deviation|Mean
2677976|NCT01426269|Secondary|Period 2: Clinician's Erythema Assessment|The evaluator (investigator) assessed the severity of erythema at baseline and each postbaseline visit using a total erythema score. The erythema of 5 areas of the face (forehead, chin, nose, right cheek, left cheek) was scored using a 5 point Clinician's Erythema Assessment scale (0 = none, 1 = mild, 2 = moderate, 3 = significant, 4 = severe). The total of the 5 individual erythema scores scores was the total erythema score.|Period 2 (40 Weeks)||||units on a scale||Standard Deviation|Mean
2677977|NCT01426269|Secondary|Period 2: Investigator's Global Assessment Success|The evaluator (investigator) assessed the severity of rosacea at baseline and each postbaseline visit using a 5 point Investigator's Global Assessment scale. Subjects scores were then dichotomized into success (clear or near clear score) or failure (mild, moderate, or severe score).|Period 2 (40 weeks)||||participants|||Number
2677978|NCT01426269|Primary|Period 2: Number of Subjects Who Relapsed|"Subjects who relapsed during phase 2 were discontinued. Relapse was defined as meeting any one of the following criteria:~A return to the baseline lesion count~A return to the baseline IGA score~The investigator determines that a change in rosacea treatment is warranted due to the subject's clinical condition. The numbers reported here are accumulative numbers for each arm."|Period 2 (40 weeks)||||participants|||Number
2677979|NCT01426230|Primary|Change From Baseline to End of Study in LOCF VAS|"Change from baseline in pain score on visual analog scale (VAS) (intensity scored from No Pain (0mm) to Worst Possible Pain (100mm)) at Week 8 of treatment; last observation carried forward (LOCF) analysis"|8 weeks (Baseline and Week 8)|The Number of Participants Analyzed was based on the available VAS.|||scores on a scale||95% Confidence Interval|Mean
2677980|NCT01426217|Secondary|Presence of Positive Bacterial Culture in IV Stopcock Due to Effluent Contamination|Open lumen ports were removed from the patient; sent directly to the anesthesiology microbiology laboratory; connected by the same clinical laboratory scientist to sterile catheters using sterile, aseptic technique; and injected directly into a BacT/Alert 3D system (bioMérieux Inc., Durham, NC) with 2 mL of sterile saline per port. BacT/Alert is a blood culture system that automatically monitors bacterial growth using colorimetry; a sensor inserted at the bottom of the bottle changes color on detecting the carbon dioxide produced by the growth of the bacteria. Catheters were then removed, and the bottles were directly incubated in the BacT/Alert system for 5 days or until positive. Once positive, the liquid in the bottle was examined to identify the organism.|Until positive, up to 5 days|Specific data for each arm can not be obtained. Sincere efforts were made to obtain and report the data, however, no data is available.|||cases of effluent contamination|||Number
2677981|NCT01426217|Primary|Presence of Bacterial IV Stopcock Lumen Contamination|The presence of bacteria in the stopcock lumen was assessed by analyzing swab cultures of the lumens. Each swab potentially containing bacteria from any of the 3 lumens of the stopcock sets were analyzed|48 hours||||percent stopcock contamination rate|Operating Rooms||Number
2677982|NCT01426191|Secondary|Clinical Effect|outcome:1.clinical cure 2. clinical failure population included patients who received the study drug, complied with the study protocol, did not have a missing or indeterminate clinical outcome response at the test-of-cure (TOC) visit, and had no confounding factors that interfered with the assessment of clinical outcome (e.g., use of nonstudy systemic antibiotic therapy on or after the first dose of the study drug for reasons other than treatment failure).|at weeks 4,day22-28|included all the participants|||Participants|||Count of Participants
2677983|NCT01426191|Primary|Number of Participants With Adverse Events|the incidence(%)of allergies, skin rashes, shock,death, etc.|day0-day22-28||||Participants|||Count of Participants
2677984|NCT01426113|Primary|Change From Baseline in Intraocular Pressure (IOP) in the Study Eye|IOP is a measure of the fluid pressure inside the study eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive change from baseline indicates an increase in IOP (worsening). Due to lack of enrollment, analysis was not performed for this outcome measure.|Baseline, Week 6|Due to early termination of the study, no statistical analysis was performed and no data summaries were generated. From a target of 120 patients, only 6 patients (3 in each group) were enrolled.||||||
2677985|NCT01426009|Secondary|Treatment Responders (Percentage of Subjects With Clinically Meaningful Change From Pre-dose in Trough FEV1 on Day 1 and Day 7)|percentage of subjects with clinically meaningful change from pre-dose in trough FEV1 on Day 1 and Day 7 Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.|Day 1 and Day 7|All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 through FEV1 values were included in the modified intent-to-treat (mITT) analysis set|||percentage of participants|||Number
2677986|NCT01426009|Secondary|Rescue Medication Use|Mean number of puffs of daily rescue medication|Day 1 through Day 7|All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 through FEV1 values were included in the modified intent-to-treat (mITT) analysis set|||average daily number of puffs||Standard Deviation|Mean
2677987|NCT01426009|Secondary|Number of Participants With Adverse Events, Vital Signs, and Clinically Significant Abnormal ECG Values and Laboratory Tests|AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. Vital signs were performed during the screening period to confirm study eligibility and at the final study visit. ECGs were performed during the screening period to confirm study eligibility. Vital signs and ECG were additionally collected within 30 minutes pre-dose; and 30 minutes, and 1, 2, 4, 6, 12 hours, and 23 hours 45 minutes post-dose within each treatment period. Clinical laboratory assessments were conducted during the screening period, at each study visit during each treatment period, and at the final study visit.|Day 1 through Day 7|All subjects who received at least one dose of study medication were included in the safety analysis.|||Participants|||Count of Participants
2677988|NCT01426009|Secondary|Treatment Responders (Number of Subjects With Clinically Meaningful Change From Pre-dose in Trough FEV1 on Day 1 and Day 7)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Clinically meaningful is defined as when the change from baseline (mean of the two pre-dose values at Day 1) in 24 hour trough FEV1 on a SUN-101 treatment is more than 100 mL compared to the mean change in trough FEV1 from all subjects on the placebo treatment.|Day 1 and Day 7|All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 through FEV1 values were included in the modified intent-to-treat (mITT) analysis set|||number of participants|||Number
2716044|NCT01128179|Secondary|Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF)||12 weeks|PP|||mmol/L||Standard Error|Least Squares Mean
2677990|NCT01426009|Primary|Standardized Change in FEV1 Area Under the Curve (AUC) (0-12hr , 12-24hr, 0-24hr) on Day 1 and Day 7|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. The standardized FEV1 AUC(0-12hr and 12-24hr) on Day 1 and Day 7 was calculated using the trapezoidal rule from the changes in FEV1 at Day 1 and Day 7, respectively, from the baseline value (the mean of the two FEV1 values at 45 minutes and 15 minutes prior to morning dose at Day 1 of the respective Treatment Periods) and dividing by the actual length of the time interval.|Day 1 and Day 7|All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 trough FEV1 values were included in the modified intent-to-treat (mITT) analysis set|||liters||Standard Deviation|Mean
2677991|NCT01426009|Primary|Mean Change in 24 Post Dose Trough Forced Expiratory Volume in 1 Second (FEV1)|Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the mean of the spirometry values collected at 23 hours 30 minutes and 24 hours post dose for Day 1 and Day 7 within each Treatment Period. Baseline was calculated as the mean of the FEV1 values at 45 minutes and 15 minutes prior to the morning dose at Day 1 of each Treatment Period. Change from baseline was calculated as the trough FEV1 value minus the baseline for Day 1 and Day 7.|Day 1 and Day 7|All subjects who received at least one dose of study medication and who had Day 1 pre-dose and Day 7 trough FEV1 values were included in the modified intent to treat analysis set|||liters||Standard Deviation|Mean
2677992|NCT01425879|Secondary|Progression-free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|From start of treatment to time of documented progression or death whichever occurs first, assessed up to 4 weeks after completion of study treatment||||months||95% Confidence Interval|Mean
2677993|NCT01425879|Secondary|Overall Survival|Analyzed using Kaplan-Meier method.|From study initiation to time of death, assessed up to 4 weeks after completion of study treatment||||months||95% Confidence Interval|Median
2677994|NCT01425879|Secondary|Frequency of Adverse Events Related to MK-2206|Severity of adverse events is graded according to the NCI CTCAE 4.0.|Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year||||percentage of patients|||Number
2677995|NCT01425879|Primary|Overall Response Rate (Complete and Partial Response) as Defined by RECIST 1.1|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year||||patients|||Number
2677996|NCT01425853|Secondary|Biomarker Analysis|The following biomarkers will be evaluated: COMP, Coll2-1, Coll2-1 NO2 and Fib3-2|6 months|||||||
2677997|NCT01425853|Secondary|Number of Adverse Events Defined by Relationship With Treatment|The safety evaluation was done in the set of randomized patients who took at least one dose of the medication|6 months|Safety population|||number of events|||Number
2677998|NCT01425853|Secondary|Number of Participants With at Least One Adverse Events|The safety evaluation was done in the set of randomized patients who took at least one dose of the medication|6 months|Safety population|||number of participants|||Number
2677999|NCT01425853|Secondary|Health Status According to EuroQoL|"EuroQoL-5D was a standardized instrument for use as a measure of health outcome that provides a simple descriptive profile and a single index value for health status. It was assessed at all of the study visits.~The EQ-5D-3L essentially consists of 2 pages - the EQ-5D descriptive system (page 2) and the EQ visual analogue scale (EQ VAS) (page 3). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. Total scale range for each dimension reported is 1 to 3.~The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.~Total scale range for VAS dimension reported is 0 to 100."|6 months|ADO on PP population|||points||Standard Deviation|Mean
2678000|NCT01425853|Secondary|Patient's and Investigator's Global Assessment of Response to Therapy|"The investigator were asked to evaluated the patient's response to therapy of the index knee by marking a (I) a VAS scale with range 0 mm (best) and 100 mm (worst) as follows: Left hand marker Excellent-Best possible anticipated response, considering the severity and stage of the disease, right hand marker None-no response, absence of drug effect."|6 months|Investigator and Patient's global assessment assessment of response to therapy. ADO on PP population.|||units on a scale||Standard Deviation|Mean
2678001|NCT01425853|Secondary|Patient's Global Assessment (PGA) and Investigator's Global Assessment (IGA) of Disease Activity|"Patients were asked to quantify their disease status on a VAS scale with range 0 mm (best) and 100 mm (worst) as follows: Considering all the ways your arthritis of the knee affects you, mark (I) on the scale how well you are doing. Left hand marker Very Well, Right hand marked Very Poor."|6 months|Patient and Investigator's global assessment of disease activity. ADO on PP population|||units on a scale||Standard Deviation|Mean
2678002|NCT01425853|Secondary|Consumption of Rescue Medication|"Use of rescue medication as number of paracetamol tablets 500 mg since the last visit. The tablet count was reconciled with the patient diary.~Total Number of pills per month"|6 months|Consumption of rescue medication (number of daily tablets consumed). ADO on PP population. daily tablets consumed/month|||daily tablets consumed/month||Standard Deviation|Mean
2678003|NCT01425853|Secondary|Percentage of Presence of Joint Effusion|Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion.|6 months|ADO on PP population|||percentage of participants|||Number
2678004|NCT01425853|Secondary|Percentage of Presence of Joint Swelling|Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion.|6 months|ADO on PP population|||percentage of participants|||Number
2678041|NCT01425749|Secondary|Characterization of the Maturation and Activation of Dendritic Cell (DC) Populations in the Sentinel Immunized Node (SIN) After Treatment With MAGE-A3 ASCI.|Number of CD83+ cells (mature DC) and CD1a+ cells (immature DC/Langerhans cells) per mm^2 in cross-sections of sentinel immunized nodes|Over 3 weeks|Evaluable patients with sufficient node sample for the analysis of DC infiltrates.|||cells per mm^2 in SIN||Standard Deviation|Mean
2678005|NCT01425853|Secondary|Percentage of Participants With Response as Defined by Outcome Variables for Osteoarthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI)|"The OARSI Standing Committee for Clinical Trials Response Criteria Initiative and the OMERACT committee, in concert with the international rheumatology community, has led to the development of a uniform core set of outcome measures for OA. One of the objectives was to propose a set of criteria for measurement based on multiple domains to present the results of changes after treatment in symptomatic parameters as a single variable for clinical trials.~To be considered as responder patients should met one the following criteria:~High improvement in pain or in function ≥ 50% and absolute change ≥ 20 or~Improvement in at least 2 of the 3 following:~Pain ≥ 20% and absolute change ≥ 10~Function ≥ 20% and absolute change ≥ 10~Patient's global assessment ≥ 20% and absolute change ≥ 10"|6 months|ADO on PP population|||percentage of participants|||Number
2678006|NCT01425853|Secondary|Huskisson's VAS|"Visual Analogue Scale: 0 No Pain 100 Maximum Pain Huskisson's VAS measures global pain intensity. Patients were asked to quantify their disease status on a 100 mm VAS as follows: Please indicate the severity of knee pain experienced during the last 48 hours by marking a (I) through the line. Left hand marker represents No pain and right hand marker represents The worst pain imaginable."|6 months|ADO on PP population|||units on a scale||Standard Deviation|Mean
2678007|NCT01425853|Secondary|WOMAC Function Subscale|Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Function to 1700 Maximum Function WOMAC functional limitation subscale was used to measure the functionality of the knee with pain. Seventeen items are used to assess functionality of the knee: tair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties.|6 months||||units on a scale||Standard Deviation|Mean
2678008|NCT01425853|Secondary|WOMAC Stiffness Subscale|Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Stiffness to 200 Maximum Stiffness WOMAC stiffness subscale was used to measure the stiffness of the knee with pain. Two items are used to assess stiffness grade: after first waking and later in the day.|6 months|ADO on PP population|||units on a scale||Standard Deviation|Mean
2678009|NCT01425853|Primary|WOMAC Pain Subscale|Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale Score Range: 0 (no pain) - 500 (maximum pain) The study was designed such that the outcome of primary interest is knee pain related to OA. The measure selected to best evaluate this is an improvement in the WOMAC pain subscales. This subscale consists of 5 items which assesses the pain during walking, using stairs, in bed, sitting or lying, and standing.|6 months|Imputed data on PP population|||units on a scale||Standard Deviation|Mean
2678010|NCT01425814|Secondary|Absolute Inspiratory Capacity (IC) Values|At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS|Up to Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678011|NCT01425814|Secondary|Change From Baseline in Inspiratory Capacity (IC)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS|Up to Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678012|NCT01425814|Secondary|Time to Peak Forced Vital Capacity (FVC)|At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 1|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Hours||Standard Error|Mean
2678013|NCT01425814|Secondary|Change From Baseline in Peak Forced Vital Capacity (FVC)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 1|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678014|NCT01425814|Secondary|Absolute Forced Vital Capacity (FVC) Values|At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Up to Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678015|NCT01425814|Secondary|Change From Baseline in Forced Vital Capacity (FVC)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Up to Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678042|NCT01425749|Secondary|Identification of Antibody Responses to MAGE-A3 After MAGE-A3 ASCI Administration as a Measure of Immunogenicity.|Antibody responses were assessed in serum by ELISA, assay for IgG. Seroconversion was defined as a detectable Ab response by ELISA (>20 EU/ml).|Over 6 months, typically weeks 1, 7, 13, 26|All eligible participants.|||percentage of evaluable participantes|||Number
2679495|NCT01410604|Secondary|Fasting Plasma Glucose|Change from baseline in Fasting plasma glucose after 3 months of treatment.|baseline and 3 months||||mg/dL||Standard Deviation|Mean
2678016|NCT01425814|Secondary|Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 1|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678017|NCT01425814|Secondary|Change From Baseline in Trough Forced Vital Capacity (FVC)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1 At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678018|NCT01425814|Secondary|Time to Peak Forced Expiratory Volume in One Second (FEV1)|At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 1|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Hours||Standard Error|Mean
2678019|NCT01425814|Secondary|Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 1|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678020|NCT01425814|Secondary|Absolute Forced Expiratory Volume in One Second (FEV1) Values|At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Up to Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678021|NCT01425814|Secondary|Change From Baseline in Forced Expiratory Volume in One Second (FEV1)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Up to Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678022|NCT01425814|Secondary|Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 1|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678023|NCT01425814|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1 At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected|Day 2|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678024|NCT01425801|Secondary|Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h|Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678070|NCT01425463|Secondary|Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 4||From Baseline to Week 4|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.|||gramm per liter (g/L)||Standard Deviation|Mean
2678025|NCT01425801|Secondary|Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h|Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678026|NCT01425801|Secondary|Change From Baseline in Normalized Forced Vital Capacity (FVC) Area Under the Curve (AUC)|FVC was normalized to baseline. Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h|Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678027|NCT01425801|Secondary|Change From Baseline to Trough Forced Vital Capacity (FVC)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.|Baseline and +23 h +24 h post-dose|Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678028|NCT01425801|Secondary|Time to Peak Forced Vital Capacity (FVC)|The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.|+15 min, +30 min, +1 h, +2 h, +3 h, +4 h|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Hours||Standard Deviation|Mean
2678029|NCT01425801|Secondary|Peak Forced Vital Capacity (FVC)|The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.|+15 min, +30 min, +1 h, +2 h, +3 h, +4 h|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678030|NCT01425801|Secondary|Change From Baseline in Peak Forced Vital Capacity (FVC)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678031|NCT01425801|Secondary|Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h|Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Percent change||Standard Error|Least Squares Mean
2678032|NCT01425801|Secondary|Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected. The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h|Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678033|NCT01425801|Secondary|Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h|Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678034|NCT01425801|Secondary|Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24h at Day 1|FEV1 was normalized to baseline. Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h|Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678035|NCT01425801|Secondary|Change From Baseline to Trough Forced Expiratory Volume in One Second (FEV1)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.|Baseline and +23 h and +24 h post-dose|Patients in the ITT population with available data at the timepoints of interest. ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678036|NCT01425801|Secondary|Time to Peak Forced Expiratory Volume in One Second (FEV1)|The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.|+15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Hours||Standard Deviation|Mean
2678037|NCT01425801|Secondary|Peak Forced Expiratory Volume in One Second (FEV1)|The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning on Day 1. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.|+15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678038|NCT01425801|Secondary|Percentage Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Percent change||Standard Error|Least Squares Mean
2678039|NCT01425801|Primary|Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)|Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.|Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose|ITT population defined as patients who took at least one dose of investigational medicinal product and had at least a baseline and one post-dose value of FEV1 from at least one treatment period|||Liters||Standard Error|Least Squares Mean
2678040|NCT01425749|Secondary|A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).|Cells per mm^2 in the superficial dermis at the vaccine site microenvironment, by enumeration of immunohistochemically stained slides. Biopsies of the vaccine sites were taken at week 1 (1 week after the first vaccine) and week 7 (1 week after the 3rd vaccine). This only was evaluable in Arm B patients.|Over 6 months|Participants enrolled on Arm B who had sufficient biopsy site samples.|||cells per mm^2 of dermis||Standard Deviation|Mean
2678071|NCT01425463|Secondary|Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 2||From Baseline to Week 2|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.|||gramm per liter (g/L)||Standard Deviation|Mean
2678043|NCT01425749|Secondary|Enumeration of CD4+ and CD8+ T Cells Reactive to MAGE-A3 Epitopes in Peripheral Blood as a Measure of Immunogenicity.|The analysis determined the proportion of CD4+ (and/or CD8+) T cells producing IFN-gamma or TNFα, or both, in response to MAGE-A3 peptide pools (with irrelevant peptide as negative control). T cell response was defined when T cells producing both IFNγ and TNFα in response to MAGE-A3 peptides exceeded (a) twice the maximum of 2 negative controls (PRAME peptides, media only), corrected for pre-existing response; and (b) exceeded the negative controls by at least 0.2% of the T cell population. These criteria also were used to define immunogenicity by ELIspot (IFNγ only). If the negative control values for a given sample were zero, a meaningful fold-increase could not be calculated; so, in those cases, we used the minimum detectable value among all similar assays (0.06%) as the negative control value for that sample.|Over 6 months|All eligible patients with evaluable peripheral blood mononuclear cells; this corresponds to all enrolled patients.|||participants|||Number
2678044|NCT01425749|Primary|Enumeration of CD4 and CD8 T Cell Responses to MAGE-A3 Epitopes in the Injection Site-draining Lymph Node (Sentinel Immunized Node, SIN) as a Measure of Immunogenicity.|Flow cytometry on in vitro stimulated lymphocytes. A positive immune response was identified as one with bifunctional CD4+ or CD8+ T cells, producing both TNF alpha and IFN-gamma after exposure to antigen.|One week after 3 doses of study drug, on day 22.|Eligible participants with evaluable sentinel immunized node specimens.|||participants|||Number
2678045|NCT01425749|Primary|Number of Participants With Treatment-related Adverse Events as a Measure of Safety and Tolerability|grade 2 treatment-related adverse events graded by CTCAE v4|Over 6 months|All eligible patients.|||participants|||Number
2678046|NCT01425723|Secondary|Participant's Assessment of Response (Excellent or Good Response) to rFIXFc Injections for the Treatment of Bleeding Episodes Using a 4-Point Scale|Using eDiary, participant received rating for treatment response to any bleeding episode (BE) using 4-point scale- 1=Excellent: Abrupt pain relief and/or improvement in signs of bleeding within approximately (approx.) 8 hours (h) after initial injection (inj.); 2=Good: Definite pain relief and/or improvement in signs of bleeding within approx. 8h after an injection, but possibly requiring more than 1 injection after 24-48h for complete resolution; 3=Moderate: Probable/slight beneficial effect within 8h after initial injection and requires more than 1 injection and 4=None: No improvement, or condition worsens within approx. 8h after initial injection. This assessment was to be made approx. 8 to 12h from time the injection was given to treat BE and prior to any additional doses of rFIXFc given for same bleeding episode. Percentages are based on the number of bleeding episodes for which a response (excellent or good) was provided for the first injection during the efficacy period.|Approximately 5 years|FAS was analyzed. Data was summarized by treatment regimen for participants from study 998HB102 and by age cohort (<6 years and 6 to <12 years old) and treatment regimen for participants from study 9HB02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.|||Injections|Injections||Count of Units
2678047|NCT01425723|Secondary|Physicians' Global Assessment of Participant's Response to rFIXFc Regimen Using a 4-Point Scale|Participants were assessed for response to their rFIXFc regimen using following 4-point scale: 1=Excellent: bleeding episodes responded to less than or equal to (<=)usual number of injections or dose of rFIXFc or rate of breakthrough bleeding during prophylaxis was <= that usually observed; 2=Effective: most bleeding episodes responded to same number of injections and dose, but some required more injections or higher doses, or there was minor increase in rate of breakthrough; 3=Partially Effective: bleeding episodes most often required more injections and/or higher doses than expected or adequate breakthrough bleeding prevention during prophylaxis required more frequent injections and/or higher doses and 4=Ineffective: routine failure to control hemostasis/hemostatic control require additional agents. Total number of scale responses =total count of scale responses for all participants; multiple responses per participant including those at scheduled and unscheduled visits are counted.|Approximately 5 years|FAS included all participants who received at least 1 dose of rFIXFc. Data was summarized by treatment regimen for participants from Study 998HB102 and Study 9HB02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.|||Responses|Responses||Count of Units
2678048|NCT01425723|Secondary|Annualized rFIXFc Consumption (International Units Per Kilogram [IU/kg])|Annualized consumption = (total international unit per kilogram [IU/kg] of study treatment received during the efficacy period / total number of days during the efficacy period) multiplied by 365.25. Efficacy period reflects sum of all intervals of time during which participants were treated with rFIXFc per treatment regimen excluding major and minor surgical/rehabilitation periods and large injection intervals. Annualized consumption was summarized by treatment regimen for participants from study 998HB102 and by age cohort (<6 years and 6 to <12 years old) and treatment regimen for participants from study 9HB02PED as per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.|Approximately 5 years|FAS included all participants who received at least 1 dose of rFIXFc. Here 'n' (number analyzed) signifies number of participants who were analyzed in each treatment regimen, for each arm, respectively.|||IU per kilogram per participant per year||Inter-Quartile Range|Median
2678049|NCT01425723|Secondary|Total Number of Exposure Days (EDs)|An exposure day is a 24-hour period in which one or more rFIXFc injections are given. The total number of days of exposure to rFIXFc were summarized by treatment regimen for participants from study 998HB102 and by age cohort (<6 years and 6 to <12 years old) and treatment regimen for participants from study 9HB02PED as per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.|Approximately 5 years|Safety Analysis Set included participants who received at least 1 dose of rFIXFc in study 9HB01EXT. Here 'n' (number analyzed) signifies number of participants who were analyzed in each treatment regimen, for each arm, respectively.|||days||Full Range|Median
2678072|NCT01425463|Primary|Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 12||From Baseline to Week 12|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.|||gramm per liter (g/L)||Standard Deviation|Mean
2678073|NCT01425359|Secondary|Patient's Global Impression of Change (PGIC) Scale Score|The PGIC was completed at the end of treatment/last visit.The PGIC scale measures the change in the participant's overall status since the beginning of the study on a scale ranging from 1 (no change or worse) to 7 (very much improved).|8 weeks|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Error|Mean
2678050|NCT01425723|Secondary|Annualized Spontaneous Joint Bleeding Episodes|Bleeding episodes were classified as spontaneous if participant records a bleeding event when there is no known contributing factor such as definite trauma/antecedent strenuous activity. In addition, location of bleed (joint, internal, skin/mucosa or muscle) were also collected. Annualized spontaneous joint bleeding episodes=(Number of spontaneous joint bleeding episodes during efficacy period/number of days during efficacy period)*365.25. Efficacy period reflects sum of all intervals of time during which participants were treated with rFIXFc per treatment regimen excluding major and minor surgical/rehabilitation periods and large injection intervals. Bleeding episodes were summarized by treatment regimen for participants from study 998HB102 and by age cohort (<6 years and 6 to <12 years old) and treatment regimen for participants from study 9HB02PED as per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.|Approximately 5 years|FAS included all participants who received at least 1 dose of rFIXFc. Here 'n' (number analyzed) signifies number of participants who were analyzed in each treatment regimen, for each arm, respectively.|||episodes per participant per year||Inter-Quartile Range|Median
2678051|NCT01425723|Secondary|Annualized Bleeding Rate (ABR)|ABR is annualized number of bleeding episodes per participant per year. Bleeding episodes were classified as spontaneous if participant records bleeding event when there is no known contributing factor such as definite trauma/antecedent strenuous activity and classified as traumatic if participant records bleeding event when there is known reason for bleed. ABR=(Number of bleeding episodes during efficacy period/number of days during efficacy period)*365.25. Efficacy period reflects sum of all intervals of time during which participants were treated with rFIXFc per treatment regimen excluding major and minor surgical/rehabilitation periods and large injection intervals. ABR was summarized by treatment regimen for participants from study 998HB102 and by age cohort (<6 years and 6 to <12 years old) and treatment regimen for participants from study 9HB02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.|Approximately 5 years|Full Analysis Set (FAS) included all participants who received at least 1 dose of rFIXFc. Here 'n' (number analyzed) signifies number of participants who were analyzed in each treatment regimen, for each arm, respectively.|||episodes per participant per year||Inter-Quartile Range|Median
2678052|NCT01425723|Primary|Number of Participants With Any Positive Inhibitor Development|An inhibitor test result greater than or equal to (>=)0.6 Bethesda units per milliliter (BU/mL), confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. Both tests were to be performed by the central laboratory using the Nijmegen-modified Bethesda Assay. Data was summarized by treatment regimen for participants from Study 998HB102 and by age cohort (<6 years and 6 to <12 years old) and treatment regimen for participants from Study 9HB02PED per planned analysis. Participants were included in summary of more than 1 treatment regimen if their regimen changed during study.|Approximately 5 years|Safety Analysis Set included participants who received at least 1 dose of Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc) in study 9HB01EXT.|||Participants|||Count of Participants
2678053|NCT01425632|Secondary|Plasma Concentrations of Unchanged TAU-284 (Bepotastine Besilate) (at a Total of 3 Time Points, i.e., Before and 2 (±1) Hours After Study-drug Administration at Week 1 and Before Study-drug Administration at Week 2)||Week 2|||||||
2678054|NCT01425632|Secondary|Adverse Events and Adverse Drug Reactions||Week 2|||||||
2678055|NCT01425632|Secondary|Change From Baseline in Severity Score||Week 2|||||||
2678056|NCT01425632|Secondary|Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)||Week 2|||||||
2678057|NCT01425632|Secondary|Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)||Week 2|||||||
2678058|NCT01425632|Secondary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]||Week 2|||||||
2678059|NCT01425632|Primary|Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)|Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 4-point scale ranging from 0 (no symptoms) to 3 (severe) .|Baseline and Week 2||||units on a scale||Standard Error|Least Squares Mean
2678060|NCT01425528|Secondary|Pittsburgh Sleep Quality Index||Baseline, 8 wks, 12 wks, 24 wks (optional)|||||||
2678061|NCT01425528|Secondary|Brief Symptom Inventory||Baseline, 8 wks, 12 wks, 24 wks (optional)|||||||
2678062|NCT01425528|Secondary|Beck Depression Inventory||Baseline, 8 wks, 12 wks, 24 wks (optional)|||||||
2678063|NCT01425528|Secondary|Behavior Rating Inventory of Executive Function (BRIEF) Adult Version||Baseline, 8 wks, 12 wks, 24 wks (optional)|||||||
2678064|NCT01425528|Secondary|Hamilton Depression Rating Scale||Baseline, 8 wks, 12 wks, 24 wks (optional)|||||||
2678065|NCT01425528|Secondary|Hamilton Anxiety Rating Scale||Baseline, 8 wks, 12 wks, 24 wks (optional)|||||||
2678066|NCT01425528|Primary|Change in Neurotransmitter Metabolite Levels in Cerebral Spinal Fluid||Baseline, 8 wks, 12 wks|||||||
2678067|NCT01425528|Primary|Change in BH4 Levels in Cerebral Spinal Fluid|Identify dosing range of oral Kuvan® necessary and sufficient to normalize CSF BH4 levels in adults with GTPCH Deficiency.|Baseline, 8 wks, 12 wks|Data from 4 of 6 participants was analyzed for Kuvan Cohort 1 and for Kuvan Cohort 2 for this outcome measure. 2 participant withdrew, 1 participant's diagnosis was reclassified and we were unable to obtain baseline CSF on 1 participant.|||nmol/L||Standard Deviation|Mean
2678068|NCT01425463|Secondary|Percentage of Responders at Week 12|Responders are defined as having an increment of Hemoglobin (Hb) > 15 g/L and post-treatment Hb > 120 g/L (male) or > 110 g/L (female) at Visit 6 (Week 12).|End of Treatment Period (Week 12)|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.|||percentage of participants|||Number
2678069|NCT01425463|Secondary|Change in Hemoglobin (Hb) From Baseline (Week 0) to Week 8||From Baseline to Week 8|The Analysis Population refers to the Per-Protocol Set (PPS), which is defined as a subset of the FAS, excluding all subjects with protocol deviations considered important for the subjects’ validity concerning the efficacy analysis.|||gramm per liter (g/L)||Standard Deviation|Mean
2678074|NCT01425359|Secondary|Change From Baseline in the Short-Form 36® (SF-36) Mental and Physical Component Scores|The range of each health domain score is 0-100, with 0 indicating a poorer health state and 100 indicating a better health state. An increase in score indicates an improvement in health state. Participants were asked to complete the survey at randomization (prior to receiving treatment), and at end of treatment visit (Week 8) or early study drug discontinuation or early termination visit. The survey asked participants for responses specific to the preceding 4 weeks prior to completing the survey.|Up to 8 weeks|Participants in the Full Analysis Set with available data were analyzed.|||units on a scale||Standard Error|Mean
2678075|NCT01425359|Secondary|Percentage of the Last 6 Weeks on Treatment During Which the Angina Frequency Was ≤ 50% of the Baseline Average Weekly Angina Frequency||6 weeks|Full Analysis Set|||percentage of weeks||Standard Error|Mean
2678076|NCT01425359|Secondary|Percentage of Weeks Participants Achieved at Least a 50% Reduction in Angina Frequency|For each participant, the percentage of the last 6 weeks on treatment during which the angina frequency was less than or equal to 50% of the baseline average weekly angina frequency was determined.|6 weeks|Participants in the Full Analysis Set with available data were analyzed.|||percentage of weeks||Standard Deviation|Mean
2678077|NCT01425359|Secondary|Average Weekly Frequency of Sublingual Nitroglycerin Use Over the Last 6 Weeks of Treatment|Average weekly frequency of sublingual nitroglycerin use was defined as the total number reported during the last 6 weeks of treatment divided by the duration corresponding to the last 6 weeks of treatment.|6 weeks|Full Analysis Set|||nitroglycerin uses per week||Standard Deviation|Mean
2678078|NCT01425359|Primary|Average Weekly Angina Frequency Over the Last 6 Weeks of Treatment|"Average weekly angina frequency was defined as the total number of angina episodes reported during the last 6 weeks of treatment divided by 6 weeks.~For subjects who terminated with less than 6 weeks of treatment, frequency was calculated as the total number of angina episodes reported during the treatment period divided by the subject's actual duration of treatment."|6 weeks|Full Analysis Set (FAS): randomized participants who received at least 1 dose of randomized study drug with at least 1 postbaseline primary efficacy measurement and did not have any major eligibility violations. Participants were included in the FAS if they did not discontinue study drug prior to Day 14.|||angina attacks per week||Standard Deviation|Mean
2678079|NCT01425307|Secondary|Change of Baseline in Hepatic Iron Overload as Assessed by Liver Iron Concentration|This secondary objective will compare standard to alternative therapy for hepatic iron overload.|Baseline and 24 months|Participants with available data|||mg FE per g dry weight liver||Standard Deviation|Mean
2678080|NCT01425307|Secondary|Number of Participants With Serious Adverse Events||24 Months|||||||
2678081|NCT01425307|Secondary|Number of Participants With Liver MRI Complications|This outcome will be recorded through questions asking whether there have been Liver MRI complications at baseline, middle, and end of treatment. Any complication higher than a CTCAE grade 2 event will be reported as a SAE.|24 months|||||||
2678082|NCT01425307|Secondary|Number of Participants With Phlebotomy Complications|This outcome will be recorded on every interval visit form through questions asking whether there have been phlebotomy complications. Any complication higher than a CTCAE grade 2 event will be reported as a SAE.|24 months|||||||
2678083|NCT01425307|Secondary|Number of Participants With Hydroxyurea Toxicities|This measure will be performed on a monthly basis throughout the trial by recording the CBC and retic count.|24 Months|||||||
2678084|NCT01425307|Secondary|Number of Participants With Transfusion Events|This outcome will be recorded on every interval visit form through questions asking whether there have been transfusion complications. Any complication higher than a CTCAE grade 2 event will be reported as a SAE.|24 months|||||||
2678085|NCT01425307|Secondary|Growth and Development|This outcome will be measured by capturing height and weight monthly and conducting an annual pubertal assessment.|24 months|||||||
2678086|NCT01425307|Secondary|Neuropsychological Decline|This outcome will be measured using standardized neurocognitive tests at baseline and exit.|24 months|||||||
2678087|NCT01425307|Secondary|Functional Status|This outcome will be measured using Barthel Index testing at the beginning, middle, and end of the treatment period.|24 months|||||||
2678088|NCT01425307|Secondary|Effects on Quality of Life|Standard Quality of Life measure will be taken during specific time points as well as one newly developed Sickle Cell Disease-specific test.|24 months|||||||
2678089|NCT01425307|Secondary|Change of Baseline in Hepatic Iron Overload as Assessed by Serum Ferritin|This secondary objective will compare standard to alternative therapy for hepatic iron overload.|Baseline and 24 months||||ng per mL||Standard Deviation|Mean
2678090|NCT01425307|Secondary|Non-stroke Neurological Events|This secondary objective will compare standard to alternative treatment for the incidence of non-stroke neurological events. Data for this outcome will be collected through entry and exit neurological exams.|24 months|||||||
2678091|NCT01425307|Secondary|Primary Stroke Events|This secondary outcome measure will compare standard to alternative therapy for primary stroke events (a) primary ischemic stroke; b) primary hemorrhagic stroke|24 months|||||||
2678092|NCT01425307|Secondary|TCD Time-averaged Mean Velocity on the Non-index Side|This secondary endpoint for the TWiTCH trial will be maximum TCD time-averaged mean velocity on the non-index side. The non-index side is the side with the lower mean (averaged over baseline evaluations) of the maximum (over arteries on that side) TCD time-averaged velocity. Values of the secondary endpoint will be obtained at clinic visits during baseline and during the 24-month treatment period.|24 months|||||||
2678093|NCT01425307|Primary|Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side|The primary endpoint for the TWiTCH trial was the difference between the treatment groups of the maximum TCD TAMV on the index side, calculated from a mixed model. The index side is the side with the higher mean (averaged over baseline evaluations) of the maximum (over arteries on that side) TCD time-averaged velocity. Values of the TAMV on the index site were obtained at clinic visits during baseline and during the treatment period.|Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).|Intention-to-Treat|||cm/sec||95% Confidence Interval|Mean
2678113|NCT01425281|Secondary|Number of Participants With DMR (All Death, All MI, All Revascularization)|DMR is the composite of All Death, All MI, All Revascularization.|180 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678094|NCT01425281|Secondary|Number of Participants With Cumulative Stent/Scaffold Thrombosis|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.~Timings:~Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.~Definite stent thrombosis occurred by either angiographic/pathologic confirmation.~Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window~-Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus~Pathological confirmation:Evidence of recent thrombus.~Probable stent thrombosis may occur after intracoronary stenting due to:~Unexplained death within first 30 days~Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause."|0-1853 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678095|NCT01425281|Secondary|Number of Participants With Very Late Stent/Scaffold Thrombosis|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.~Timings:~Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.~Definite stent thrombosis occurred by either angiographic/pathologic confirmation.~Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window~-Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus~Pathological confirmation:Evidence of recent thrombus.~Probable stent thrombosis may occur after intracoronary stenting due to:~Unexplained death within first 30 days~Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause."|> 365 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678096|NCT01425281|Secondary|Number of Participants With Late Stent/Scaffold Thrombosis|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.~Timings:~Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.~Definite stent thrombosis occurred by either angiographic/pathologic confirmation.~Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window~-Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus~Pathological confirmation:Evidence of recent thrombus.~Probable stent thrombosis may occur after intracoronary stenting due to:~Unexplained death within first 30 days~Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause."|31-365 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678097|NCT01425281|Secondary|Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.~Timings:~Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.~Definite stent thrombosis occurred by either angiographic/pathologic confirmation.~Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window~-Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus~Pathological confirmation:Evidence of recent thrombus.~Probable stent thrombosis may occur after intracoronary stenting due to:~Unexplained death within first 30 days~Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause."|0-30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678098|NCT01425281|Secondary|Number of Participants With Subacute Stent/Scaffold Thrombosis|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.~Timings:~Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.~Definite stent thrombosis occurred by either angiographic/pathologic confirmation.~Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window~-Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus~Pathological confirmation:Evidence of recent thrombus.~Probable stent thrombosis may occur after intracoronary stenting due to:~Unexplained death within first 30 days~Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause."|> 1-30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678099|NCT01425281|Secondary|Number of Participants With Acute Stent/Scaffold Thrombosis|"Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points.~Timings:~Acute:0-24 hours;Subacute:>24 hours-30 days;Late:30 days-1 year;Very late:>1 year.~Definite stent thrombosis occurred by either angiographic/pathologic confirmation.~Angiographic confirmation:The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent&presence of at least 1 of the following criteria within a 48-hour time window~-Acute onset of ischemic symptoms at rest;New ischemic ECG changes;Typical rise&fall in cardiac biomarkers;Nonocclusive/Occlusive thrombus~Pathological confirmation:Evidence of recent thrombus.~Probable stent thrombosis may occur after intracoronary stenting due to:~Unexplained death within first 30 days~Any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis&in the absence of any other obvious cause."|<=1 day|ITT population. .|||Participants|||Count of Participants
2678114|NCT01425281|Secondary|Number of Participants With DMR (All Death, All MI, All Revascularization)|DMR is the composite of All Death, All MI, All Revascularization.|30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678100|NCT01425281|Secondary|Number of Participants Experiencing Cardiac Death/All MI|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678101|NCT01425281|Secondary|Number of Participants Experiencing Cardiac Death/All MI|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678102|NCT01425281|Secondary|Number of Participants Experiencing Cardiac Death/All MI|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Myocardial Infarction (MI)~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678103|NCT01425281|Secondary|Number of Participants Experiencing Cardiac Death/All MI|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Myocardial Infarction (MI)~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678104|NCT01425281|Secondary|Number of Participants Experiencing Cardiac Death/All MI|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Myocardial Infarction (MI)~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678105|NCT01425281|Secondary|Number of Participants Experiencing Cardiac Death/All MI|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Myocardial Infarction (MI)~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|180 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678106|NCT01425281|Secondary|Number of Participants Experiencing Cardiac Death/All MI|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Myocardial Infarction (MI)~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678107|NCT01425281|Secondary|Number of Participants Experiencing Cardiac Death/All MI|"Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves"|In-hospital (≤ 7 days of post index procedure)|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678108|NCT01425281|Secondary|Number of Participants With DMR (All Death, All MI, All Revascularization)|DMR is the composite of All Death, All MI, All Revascularization|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678109|NCT01425281|Secondary|Number of Participants With DMR (All Death, All MI, All Revascularization)|DMR is the composite of All Death, All MI, All Revascularization|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678110|NCT01425281|Secondary|Number of Participants With DMR (All Death, All MI, All Revascularization)|DMR is the composite of All Death, All MI, All Revascularization.|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678111|NCT01425281|Secondary|Number of Participants With DMR (All Death, All MI, All Revascularization)|DMR is the composite of All Death, All MI, All Revascularization.|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678112|NCT01425281|Secondary|Number of Participants With DMR (All Death, All MI, All Revascularization)|DMR is the composite of All Death, All MI, All Revascularization.|1 year|Intent-to-Treat Population (ITT).The number of participants analyzed include subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678115|NCT01425281|Secondary|Number of Participants With DMR (All Death, All MI, All Revascularization)|DMR is the composite of All Death, All MI, All Revascularization|In-hospital (≤ 7 days of post index procedure)|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678116|NCT01425281|Secondary|Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678117|NCT01425281|Secondary|Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678118|NCT01425281|Secondary|Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678119|NCT01425281|Secondary|Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678120|NCT01425281|Secondary|Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678121|NCT01425281|Secondary|Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|180 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2678122|NCT01425281|Secondary|Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678123|NCT01425281|Secondary|Number of Participants With Target Vessel Failure (TVF) (Cardiac Death, All MI, ID-TVR)|Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).|In-hospital (≤ 7 days of post index procedure)|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678124|NCT01425281|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678125|NCT01425281|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678126|NCT01425281|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678127|NCT01425281|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678128|NCT01425281|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678129|NCT01425281|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|180 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678130|NCT01425281|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2679496|NCT01410604|Primary|Tumour Necrosis Factor Alpha|Change from baseline in Tumour necrosis factor alpha after 3 months of treatment.|baseline and 3 months||||pg/mL||Standard Deviation|Mean
2678131|NCT01425281|Secondary|Number of Participants With Major Adverse Cardiac Events (MACE) (Cardiac Death, All MI, ID-TLR)|Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).|In-hospital (≤ 7 days of post index procedure)|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2678132|NCT01425281|Secondary|Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678133|NCT01425281|Secondary|Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678134|NCT01425281|Secondary|Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678135|NCT01425281|Secondary|Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678136|NCT01425281|Secondary|Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678137|NCT01425281|Secondary|Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, TV-MI, ID-TLR)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|180 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678138|NCT01425281|Secondary|Number of Participants With Target Lesion Failure (TLF) (Cardiac Death, Target Vessel Myocardial Infarction (TV-MI), ID-TLR)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678139|NCT01425281|Secondary|Number of Participants With Target Lesion Failure (TLF) (Cardiac Death,(Target Vessel Myocardial Infarction(TV-MI), ID-TLR)|Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).|In-hospital (≤ 7 days of post index procedure)|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678140|NCT01425281|Secondary|Number of Participants Experiencing All Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI)~Q wave MI Development of new, pathological Q wave on the ECG.~Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2678141|NCT01425281|Secondary|Number of Participants Experiencing All Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI)~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678142|NCT01425281|Secondary|Number of Participants Experiencing All Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI)~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2679497|NCT01410604|Primary|Interleukin 6|Change from baseline in Interleukin 6 after 3 months of treatment.|baseline and 3 months||||pg/mL||Standard Deviation|Mean
2678143|NCT01425281|Secondary|Number of Participants Experiencing All Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI)~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678144|NCT01425281|Secondary|Number of Participants Experiencing All Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI)~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678145|NCT01425281|Secondary|Number of Participants Experiencing All Death/All MI|"All deaths includes~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI)~Q wave MI Development of new, pathological Q wave on the ECG.~Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|180 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678146|NCT01425281|Secondary|Number of Participants Experiencing All Death/All MI|"All deaths includes~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI)~Q wave MI Development of new, pathological Q wave on the ECG.~Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2678147|NCT01425281|Secondary|Number of Participants Experiencing All Death/All MI|"All deaths includes~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.~Myocardial Infarction (MI) Q wave MI Development of new, pathological Q wave on the ECG. Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|In-hospital (≤ 7 days of post index procedure)|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2678148|NCT01425281|Secondary|Number of Participants With All Revascularization|Revascularization: Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold. Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion. Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion. Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2678149|NCT01425281|Secondary|Number of Participants With All Revascularization|"Revascularization:~Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.~Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.~Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.~Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel."|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678150|NCT01425281|Secondary|Number of Participants With All Revascularization|"Revascularization:~Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.~Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.~Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.~Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel."|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678151|NCT01425281|Secondary|Number of Participants With All Revascularization|"Revascularization:~Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.~Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.~Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.~Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel."|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678152|NCT01425281|Secondary|Number of Participants With All Revascularization|"Revascularization:~Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.~Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.~Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.~Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel."|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678153|NCT01425281|Secondary|Number of Participants With All Revascularization|"Revascularization:~Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.~Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.~Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.~Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel."|180 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2678154|NCT01425281|Secondary|Number of Participants With All Revascularization|"Revascularization:~Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.~Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.~Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.~Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel."|30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678155|NCT01425281|Secondary|Number of Participants With All Revascularization|"Revascularization:~Target Lesion Revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the scaffold and to 5 mm distal to the test scaffold.~Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion.~Non Target Lesion Revascularization (Non-TLR) is any revascularization in the target vessel for a lesion other than the target lesion.~Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel."|In-hospital (≤ 7 days of post index procedure)|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2678156|NCT01425281|Secondary|Number of Participants With Non-Target Vessel Revascularization (Non-TVR)|Non Target Vessel Revascularization (Non-TVR) is any revascularization in a vessel other than the target vessel.|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678157|NCT01425281|Secondary|Number of Participants With Non Target Vessel Revascularization (Non-TVR)|Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678200|NCT01425268|Secondary|Expansion Days|The median number of days taken to complete the expansion process.|12 months|All breasts successfully exchange from expander to standard breast implant were analyzed for the length of time to complete the expansion process (days)|||days|breasts|Full Range|Median
2678158|NCT01425281|Secondary|Number of Participants With Non Target Vessel Revascularization (Non-TVR)|Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678159|NCT01425281|Secondary|Number of Participants With Non Target Vessel Revascularization (Non-TVR)|Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678160|NCT01425281|Secondary|Number of Participants With Non Target Vessel Revascularization (Non-TVR)|Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678161|NCT01425281|Secondary|Number of Participants With Non Target Vessel Revascularization (Non-TVR)|Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.|180 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678162|NCT01425281|Secondary|Number of Participants With Non Target Vessel Revascularization (Non-TVR)|Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.|30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2678163|NCT01425281|Secondary|Number of Participants With Non Target Vessel Revascularization (Non-TVR)|Non Target Vessel Revascularization (Non-TVR)is any revascularization in a vessel other than the target vessel.|In-hospital (≤ 7 days of post index procedure)|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678164|NCT01425281|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2678165|NCT01425281|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678166|NCT01425281|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678167|NCT01425281|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678168|NCT01425281|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678169|NCT01425281|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|180 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2678170|NCT01425281|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2678171|NCT01425281|Secondary|Number of Participants With Target Vessel Revascularization (TVR)|Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.|In-hospital (≤ 7 days of post index procedure)|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2678217|NCT01424930|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone|The table below shows median Tmax of Abiraterone. The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Day 7 and Day 14|Participants who received at least 1 dose of study medication and were included in the pharmacokinetics analysis.|||hours||Full Range|Median
2678172|NCT01425281|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678173|NCT01425281|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678174|NCT01425281|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678175|NCT01425281|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678176|NCT01425281|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678177|NCT01425281|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|180 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2678178|NCT01425281|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated (CI) or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2678179|NCT01425281|Secondary|Number of Participants With Target Lesion Revascularization (TLR)|"Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated (CI) or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.~The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent."|In-hospital (≤ 7 days of post index procedure)|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2678180|NCT01425281|Secondary|Number of Participants With All Myocardial Infarction (Per Protocol Definition)|"Myocardial Infarction (MI)~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678181|NCT01425281|Secondary|Number of Participants With All Myocardial Infarction (Per Protocol Definition)|"Myocardial Infarction (MI)~Q wave MI: Development of new, pathological Q wave on the ECG.~Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678182|NCT01425281|Secondary|Number of Participants With All Myocardial Infarction (Per Protocol Definition)|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678183|NCT01425281|Secondary|Number of Participants With All Myocardial Infarction (Per Protocol Definition)|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678184|NCT01425281|Secondary|Number of Participants With All Myocardial Infarction (Per Protocol Definition)|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678185|NCT01425281|Secondary|Number of Participants With All Myocardial Infarction (Per Protocol Definition)|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves."|180 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678186|NCT01425281|Secondary|Number of Participants With All Myocardial Infarction (Per Protocol Definition)|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated Creatine kinase-MB (CK-MB) in the absence of new pathological Q waves."|30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678187|NCT01425281|Secondary|Number of Participants With All Myocardial Infarction (Per Protocol Definition)|"Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG.~-Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated Creatine kinase-MB (CK-MB) in the absence of new pathological Q waves."|In-hospital (≤ 7 days of post index procedure)|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678188|NCT01425281|Secondary|Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|5 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678189|NCT01425281|Secondary|Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|4 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678190|NCT01425281|Secondary|Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678191|NCT01425281|Secondary|Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|2 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678192|NCT01425281|Secondary|Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|1 year|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.|||Participants|||Count of Participants
2678193|NCT01425281|Secondary|Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|180 Days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2678194|NCT01425281|Secondary|Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~• Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~• Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~• Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|30 days|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2678195|NCT01425281|Secondary|Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)|"All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.~Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.~Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.~Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma."|In-hospital (≤ 7 days of post index procedure)|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||Participants|||Count of Participants
2678196|NCT01425281|Secondary|Number of Participants With Procedural Success|Achievement of final in-scaffold/stent residual stenosis of less than 50% by QCA with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay.|From the start of index procedure to end of index procedure||||Participants|||Count of Participants
2678197|NCT01425281|Secondary|Device Success|Successful delivery and deployment of the first study scaffold/stent the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 50% by quantitative coronary angiography (QCA).|From the start of index procedure to end of index procedure|Device Success is measured on a per Lesion basis. Some patients had more than one lesion treated so the total number of lesions is larger than the number of patients.|||Percentage of lesions|Target lesions||Number
2678198|NCT01425281|Primary|Absolute Difference (3 Years Post-nitrate - Post Procedure Post-nitrate) In-Scaffold Minimum Lumen Diameter|In-scaffold:Within the margins of the scaffold.|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||mm|Target lesions|Standard Deviation|Mean
2678199|NCT01425281|Primary|Absolute Difference (3 Years Post Nitrate- 3 Years Pre Nitrate) In-Scaffold Mean Lumen Diameter (MLD)|In-scaffold:Within the margins of the scaffold.|3 years|ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame|||mm|Target lesions|Standard Deviation|Mean
2678236|NCT01424813|Other Pre-specified|Percent Change From Baseline in FEV1 AUC||Day 85|||||||
2678201|NCT01425268|Primary|Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event|The primary endpoint is assessed when the subject has completed tissue expansion and completed an exchange to standard breast implants. Subjects not completing the exchange procedure due to a device related event are considered failures.|12 months|Primary Analysis Population (Per Protocol Cohort) = Subjects with an expander implanted successfully with no major protocol violation (evaluated per breast). Subjects who had a bilateral procedure have each breast evaluated separately.|||Breasts|Breasts||Count of Units
2678202|NCT01425229|Primary|Cmax|Cmax after the first dose of bosentan, at steady-state, during clarithromycin|after first dose, at steady-state, during clarithromycin||||ng/ml||95% Confidence Interval|Geometric Mean
2678203|NCT01425229|Primary|AUC|AUC of bosentan after first-dose, at steady-state and during clarithromycin therapy|0-infinity; dosing interval||||h*ng/ml||95% Confidence Interval|Geometric Mean
2678204|NCT01425203|Secondary|Percentage of Participants Achieving Early Virologic Response (EVR) At Treatment Week (TW) 8|EVR was defined as an undetectable HCV-RNA level at TW 8. This analysis was conducted when all participants had completed 8 weeks of the study or had discontinued prior to TW 8.|Treatment Week 8|Full Analysis Set (FAS); all randomized participants who received at least 1 dose of any trial medication (PEG, RBV, or BOC) in the Treatment Phase. The Crossover arm had zero participants at TW8 since the first opportunity for participants in the PBO + PR Control arm to roll over to the Crossover arm was at TW12.|||percentage of participants|||Number
2678205|NCT01425203|Secondary|Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population)|SVR24 was defined as an undetectable plasma HCV-RNA level at FW24. If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.|Follow-up Week 24 (up to 72 weeks)|mITT population included all randomized participants who received ≥1 dose of experimental trial drug: BOC (for Experimental RGT BOC + PR arm) or Placebo (for PBO + PR Control arm). Participants in the PBO Control Arm who switched to the Crossover Arm were considered failures for SVR24 in this analysis and are not reported here.|||percentage of participants|||Number
2678206|NCT01425203|Primary|Percentage of Participants Achieving Sustained Virologic Response At Follow-up Week 24 (SVR24) Among Participants Who Received At Least One Dose of Any Trial Medication (Full Analysis Set Population)|SVR24 was defined as an undetectable plasma Hepatitis C Virus-ribonucleic acid (HCV-RNA) level at Follow-up Week 24 (FW24). If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.|Follow-up Week 24 (up to 72 weeks)|Full Analysis Set (FAS); all randomized participants who received at least 1 dose of any trial medication (PEG, RBV, or BOC) in the Treatment Phase. Participants in the PBO Control Arm who switched to the Crossover Arm were considered failures for SVR24 in this analysis and are not reported here.|||percentage of participants|||Number
2678207|NCT01425190|Primary|Final Dose of Boceprevir By Age Group||Day 1|This outcome measure could not be analyzed due to termination of the study prior to enrolling Cohorts 2 and 3.||||||
2678208|NCT01425190|Primary|Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir|The time at which the maximum plasma boceprevir concentration was observed.|0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose|The Per Protocol (PP) population includes all participants who complied with the protocol sufficiently to ensure that data for this assessment were likely to exhibit the effects of treatment, according to the underlying scientific model.|||Hour||Full Range|Mean
2678209|NCT01425190|Primary|Maximum Plasma Concentration (Cmax) of Single Dose Boceprevir|The maximum observed plasma concentration of boceprevir across sampling intervals was determined.|0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose|The Per Protocol (PP) population includes all participants who complied with the protocol sufficiently to ensure that data for this assessment were likely to exhibit the effects of treatment, according to the underlying scientific model.|||ng/mL||Full Range|Mean
2678210|NCT01425190|Primary|Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir|Plasma concentrations of boceprevir were determined at 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose.|0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose|The Per Protocol (PP) population includes all participants who complied with the protocol sufficiently to ensure that data for this assessment were likely to exhibit the effects of treatment, according to the underlying scientific model.|||ng hr/mL||Full Range|Mean
2678211|NCT01424943|Secondary|Parent Symptoms of Depression, Anxiety and Stress|DASS-21, brief screening measure of symptoms of depression, anxiety, and stress. Scores on each scale range from 0-21. Higher scores indicate more symptoms in each area.|baseline, 5 months||||scores on a scale||Standard Deviation|Mean
2678212|NCT01424943|Primary|KIPS|KIPS observational measure of the quality of the parent-child relationship. scores range from 1-5. Higher scores indicate a higher quality of relationship.|Baseline, 5 months||||scores on a scale||Standard Deviation|Mean
2678213|NCT01424943|Primary|Parenting Self-confidence|Toddler Care Questionnaire. Measures parent reported self-confidence in parenting a toddler. Parents rate their confidence in performing parenting tasks specific to toddlers. Higher scores indicate more confidence. Scores range from 37-185. The total sum score derived from adding the scores for the 37 items in this survey was used for this outcome measure.|Baseline, 5 months||||units on a scale||Standard Deviation|Mean
2678214|NCT01424943|Primary|Child Behavior|Child Behavior Checklist 1/5-5. A parent report measure of child behavioral problems. The score used for this outcome was the CBCL Total Score, which is a T-Score. T scores average 50 with a standard deviation of 10. Scores above 65 considered in the clinical range.|Baseline, 5 months||||T-score||Standard Deviation|Mean
2678215|NCT01424943|Primary|Parenting Style|Parenting Scale (Total Score; measure of parenting style). 30 items on the scale, scores range from 1-7 for each item with higher scores indicating dysfunctional parenting styles (laxness, over-reactivity, hostility). Scores summed and divided by 30 for total score.|Baseline, 5 months||||scores on a scale||Standard Deviation|Mean
2678216|NCT01424930|Secondary|Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)|The table below shows mean AUC24h. The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.|Day 7 and Day 14|Participants who received at least 1 dose of study medication and were included in the pharmacokinetics analysis.|||ng*h/mL||Standard Deviation|Geometric Mean
2678218|NCT01424930|Secondary|Maximum Observed Plasma Concentration (Cmax) of Abiraterone|The table below shows mean Cmax of Abiraterone. The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.|Day 7 and Day 14|Participants who received at least 1 dose of study medication and were included in the pharmacokinetics analysis.|||ng/mL||Standard Deviation|Geometric Mean
2678219|NCT01424930|Primary|Number of Participants With Grade 3 or Higher Adverse Events (AEs) of Special Interest or Grade 3 or Higher Serious AEs Due to Study Medication|AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.|Postdose on Cycle 1 Day 8 to predose on Cycle 2 Day 1|Safety population: Participants who received at least 1 dose of study medication and contributed any safety data after the start of study treatment.|||Participants|||Number
2678220|NCT01424813|Other Pre-specified|Morning Peak Expiratory Flow Reading Reported on Patient Diary||Treatment days 1 through 85|||||||
2678221|NCT01424813|Secondary|Participants With Clinically Significant Vital Sign Assessments|"For both standard and serial vital signs, participants were seated for at least 5 minutes before vital signs were assessed. Heart rate was obtained prior to the blood pressure measurement. Serial heart rate and blood pressure were conducted in the sitting position prior to the spirometry assessment; baseline measures were taken pre-dose at -30 ± 5 and -5 minutes on Day 1. Day 85 serial vital sign measures were taken in the sitting position prior to spirometry assessments pre-dose at -30 ± 5 and -5 minutes, then post-dose at 30 (±5) minutes, 1hr (± 10 min), 2hr (± 10 min), 3hr (± 10 min), 4hr (± 10 min), 5hr (± 10 min) and 6 hr (± 10 min).~Serial heart rate and blood pressure measurements that were elevated to the following criteria were considered clinically significant:~Systolic blood pressure: > 160 beats/minute Diastolic blood pressure: >100 beats/minute Heart rate: >120 beats/minute"|Day 8, Day 85|Safety population|||participants|||Number
2678222|NCT01424813|Secondary|Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group|Physical exam was recorded as normal or abnormal based on physician assessment. Format for results is: Test Baseline/Endpoint HEENT = head, eyes, ears, nose, throat|Day 1 (Baseline), Day 85|Safety population. Only participants with both baseline and endpoint physical examination findings are summarized. Two placebo participants were missing endpoint physical examinations.|||participants|||Number
2678223|NCT01424813|Secondary|Participants With Adverse Events|Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.|Day 1 to Day 92|Safety analysis set|||participants|||Number
2678224|NCT01424813|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 85.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 85|Full analysis set of participants with data at the time point|||L*hr||95% Confidence Interval|Mean
2678225|NCT01424813|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 8.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 8|Full analysis set of participants with data at the time point|||L*hr||95% Confidence Interval|Mean
2678226|NCT01424813|Other Pre-specified|Percent of Rescue Medication Free Days in the Patient Diary||Treatment days 1 through 85|||||||
2678227|NCT01424813|Other Pre-specified|Percent of Symptom Free Days on the Patient Diary||Treatment days 1 through 85|||||||
2678228|NCT01424813|Other Pre-specified|Duration of Response on Days 1, 8 and 85|Duration of response measured from the time post-dosing to the first time after the response onset (increase ≥15% above baseline) when the FEV1 decreases to less than 15% above baseline (within 6 hours after dosing) for those who responded within 30 minutes|Day 1, Day 8, Day 85|||||||
2678229|NCT01424813|Other Pre-specified|Time to Onset of Effect (Change in FEV1 of 15% From Baseline Within 30 Minutes Postdose)for Those Who Responded in 30 Minutes||Day 1, Day 8, Day 85|||||||
2678230|NCT01424813|Other Pre-specified|Duration of Response Measured From the Time Post-dosing to the First Time After the Response Onset (Increase ≥12% Above Baseline) When the FEV1 Decreases to Less Than 12% Above Baseline (Within 6 Hours After Dosing) for Those Who Responded in 30 Minutes||Day 1, Day 8, Day 85|||||||
2678231|NCT01424813|Other Pre-specified|Time to Onset of Effect (Change in FEV1 of 12% From Baseline Within 30 Minutes Postdose)||Day 1, Day 8, Day 85|||||||
2678232|NCT01424813|Other Pre-specified|Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 85||Day 85|||||||
2678233|NCT01424813|Other Pre-specified|Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 8||Day 8|||||||
2678234|NCT01424813|Other Pre-specified|Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 1||Day 1|||||||
2678235|NCT01424813|Other Pre-specified|Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose Over the 12-week Treatment Period||Day 1, Day 8, Day 85|||||||
2678240|NCT01424813|Secondary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 1.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 1|Full analysis set|||L*hr||95% Confidence Interval|Mean
2678241|NCT01424813|Primary|Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period|"FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average (by the trapezoidal rule) of FEV1 AUC 0-6 measures adjusted for the baseline measure (i.e., change from baseline at each timepoint) recorded on days 1, 8 and 85 of the treatment period. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day.~FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min."|Day 1, Day 8 and Day 85|Full analysis set which includes all participants in the intent-to-treat (ITT) population who received at least 1 dose of study medication and had at least 1 post-baseline assessment.|||L*hr||Standard Error|Mean
2678242|NCT01424670|Secondary|Proportion of Participants With Final Outcome At Month 30 As A Treatment Success Or Failure (Including Relapse) Using MGIT|Treatment success was defined as achieving SCC by 6 months using MGIT, completing the trial out to 30 months with sustained SCC and alive at the last contact for follow-up. All other participants were treatment failures who failed to achieve SCC by Month 6, achieved SCC but have a confirmed positive, early terminate from the trial prior to the Month 30 visit but are alive at the last contact for follow-up, lost to follow-up and vital status unknown and death.|Month 30|The MITT sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both.|||Participants|||Count of Participants
2678243|NCT01424670|Secondary|Mean Change From Baseline In TTD Using The MGIT System|The value for TTD was defined (in days) as the time interval from inoculation until a MGIT machine detects a positive signal for a sputum culture during the routine 42-day incubation period. TTD analysis was based only on the corresponding qualitative sputum results of pure positive and pure negative cultures in days and hours of the initial positive signal for a culture from the MGIT printout. Mean change is reported for Baseline, Week 1, Week 2, Week 3, Week 24, Week 26, and Last visit (Month 18 or last visit for participants treated beyond Month 18).|Baseline, Week 1, Week 2, Week 3, Week 24, Week 26, and Last visit (Month 18 or last visit for participants treated beyond Month 18)|The MITT sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both.|||days||Standard Deviation|Mean
2678244|NCT01424670|Secondary|Mean (Time Averaged) Area Under The Curve (AUC) Of Change From Baseline In Time To Detection (TTD) To Month 6 Using MGIT|"The value for TTD was defined (in days) as the time interval from inoculation until a MGIT machine detects a positive signal for a sputum culture. The AUC of the change from Baseline for TTD in days (from Baseline to Month 6) summarizes the overall participant response for the treatment period. The change from Baseline in original time to detection of MGIT positive signal, in days, up to 6 months was performed using AUC in MGIT. The Baseline was defined as the average of Day −1 and Day 1 values if cultures on both days were positive; if only 1 culture was positive, the value for TTD for the positive culture was used as the Baseline.~The TTD is Time to Detection measured by day, so the unit of AUC of change from baseline in TTD is day*day. Since Mean AUC is reported, which is actually Time Averaged AUC, the AUC was divided by the duration of the observation, and thus the unit of the Mean AUC is day."|Baseline, up to Month 6|The MITT sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both, who had both a baseline and at least one post baseline TTD value.|||days||Standard Deviation|Mean
2678245|NCT01424670|Secondary|Number of Participants Who Developed Resistance To Delamanid|Acquired resistance was defined as a post-baseline resistant result at any time point after a Baseline susceptible result. The overall resistance to delamanid during the trial was assessed.|Up to Month 30|The intent-to-treat (ITT) sample comprised all randomized participants.|||participants|||Number
2678246|NCT01424670|Secondary|Treatment Outcomes Assessed By Principal Investigators (PI)At The End Of Treatment With OBR|Final treatment outcomes were assessed by the Principal Investigator (PI) at the end of treatment with OBR (24 months post randomization) according to the 2008 World Health Organization (WHO) outcome definitions for treating participants with multidrug-resistant tuberculosis (MDR TB). Frequency counts and percentage of participants achieving favorable and unfavorable outcomes were provided by treatment group. Participants who had non-missing Principal Investigator assessed treatment outcomes at the end of treatment with OBR were included in the analysis.|Month 24|The MITT sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both.|||Participants|||Count of Participants
2678247|NCT01424670|Secondary|Proportion of Participants With Sustained SCC At Month 18, Month 24, And Month 30 Using MGIT|Sustained SCC was defined as SCC achieved by Month 6 and not followed by a confirmed positive thereafter, where confirmed positive was defined as 2 or more observed positive single representative culture results, not taking into account indeterminate, missing, or contaminated results. Sustained SCC was analyzed at Month 18 to 30 using MGIT.|Month 18, Month 24, and Month 30|The MITT sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both.|||Participants|||Count of Participants
2678329|NCT01424306|Secondary|Fasting Plasma Zonulin Concentrations|Zonulin concentrations will be measured by enzyme-linked immunosorbent assay in fasting plasma collected on day 9 of each diet period. Plasma zonulin is a marker of intestinal permeability.|End (day 9) of each diet period.|All completed participants combined in per protocol analysis|||ng/mL||Standard Deviation|Mean
2678248|NCT01424670|Secondary|Proportion of Participants With SCC At 2 And 6 Months Using MGIT|"SCC was evaluated at 2 and 6 months (6-month Intensive Period) using MGIT. SCC at 2 months was defined to occur at the date of collection of the first sputum specimen with mycobacterial culture negative for growth of MTB using MGIT culture, followed by at least 1 confirmatory negative MGIT culture result at least 25 days after the first negative specimen and not followed by any sputum specimens positive for growth in the MGIT culture at any point up to 3 months (Week 12).~SCC at 6 months was determined by the observation of a sputum specimen negative for growth of MTB using the MGIT culture system, followed by at least 1 confirmatory negative sputum culture at least 25 days after the first negative and not followed by a confirmed positive (defined as at least 2 observed positive results, not taking into account indeterminate, missing, or contaminated results). 2 specimens were collected at each visit and an algorithm in the SAP was used to define a single representative result."|Month 2 and Month 6|The MITT sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both.|||Participants|||Count of Participants
2678249|NCT01424670|Primary|Time To Sputum Culture Conversion (SCC) During 6-Month Intensive Period Using The Mycobacteria Growth Indicator Tube (MGIT) System|SCC at 6 months was determined by the observation of a sputum specimen negative for growth of mycobacterium tuberculosis (MTB) using the MGIT culture system, followed by at least 1 confirmatory negative sputum culture at least 25 days after the first negative and not followed by a confirmed positive (defined as at least 2 observed positive results, not taking into account indeterminate, missing, or contaminated results). 2 specimens were collected at each visit and an algorithm in the statistical analysis plan (SAP) was used to define a single representative result. Time to SCC was then defined as the interval between the date of first dose of IMP and the date of first of 2 consecutive negative single representative time points that were at least 25 days apart. The median time in days to SCC up to Month 6 is presented.|Month 6|The modified intent-to-treat (MITT) sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both.|||Days||95% Confidence Interval|Median
2678250|NCT01424644|Secondary|Number of Subjects With Unsolicited Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo|"The number of subjects reporting any unsolicited adverse reactions (AEs) when Tdap and HPV are concomitantly administered with MenACWY-CRM as compared to when Tdap and HPV vaccine are concomitantly administered with placebo.~Note: A total of 2 MenACWY-CRM+Tdap+HPV subjects reported AEs leading to premature withdrawal - one subject due to treatment emergent AE and another subject prior to study vaccination on day 1."|Throughout the study (Day 1 to Day 211).|Analysis was done on overall safety population - All subjects in the exposed population who provided postvaccination and post-baseline safety data.|||Subjects|||Number
2678251|NCT01424644|Secondary|Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap and HPV Are Concomitantly Administered With MenACWY-CRM Compared to When Tdap and HPV Are Concomitantly Administered With Placebo|The number of subjects reporting solicited local and systemic reactions following concomitant administration of MenACWY-CRM vaccine, Tdap and HPV vaccine as compared to concomitant administration of placebo with Tdap and HPV.|Day 1-7 after any vaccination.|Analysis was done on solicited safety Set - All subjects in the exposed population who provided solicited AEs.|||Subjects|||Number
2678252|NCT01424644|Secondary|Geometric Mean hSBA Titers Against N. Meningitidis Serogroups A,C,W and Y at 1 Month After Men ACWY Vaccination.|The immunogenicity was assessed in terms of geometric mean hSBA titers of MenACWY when administered concomitantly with Tdap and HPV at 1 month after 1 dose of MenACWY vaccination.|1 month post MenACWY-CRM vaccination.|Analysis was done on the MenACWY per-protocol population - all subjects who received all the relevant doses of vaccine correctly, and provided evaluable serum samples at baseline and one month postvaccination for at least one serogroup, and had no major protocol violation as defined prior to unblinding.|||Titers||95% Confidence Interval|Geometric Mean
2678253|NCT01424644|Primary|Geometric Mean Concentrations of Antibodies Against Pertussis Antigens After Concomitant Administration of Tdap With HPV and MenACWY-CRM Compared to Concomitant Administration of Tdap With HPV and Placebo|The geometric mean concentrations (GMCs) of antibodies against pertussis antigens (PT, FHA and PRN), as measured by ELISA, following concomitant administration of Tdap with HPV and MenACWY-CRM as compared to concomitant administration of Tdap with HPV and placebo.|1 month post Tdap vaccination.|Analysis was done on the Tdap per-protocol population.|||EU/mL||95% Confidence Interval|Geometric Mean
2678254|NCT01424644|Primary|Percentages of Subjects With Anti-diphtheria and Anti-tetanus Antibody Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With HPV and MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With HPV and Placebo|The percentages of subjects with anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL (as measured by ELISA) following concomitant administration of Tdap with HPV and MenACWY-CRM vaccine as compared to concomitant administration of Tdap with HPV and placebo.|1 month post Tdap vaccination.|Analysis was done on the Tdap per-protocol population, i.e., all subjects who received all the relevant doses of vaccine correctly, and provided serology results at one month postvaccination, and had no major protocol violation as defined prior to unblinding.|||percentages of subjects||95% Confidence Interval|Number
2678255|NCT01424566|Secondary|Change From Randomization Baseline In NRS Constipation At Last Visit (Up To Day 36 Of The Double-blind Period)|"Participants indicated level of constipation on an 11-point NRS, where a score of 0 was no constipation, and 10 was constipation as bad as you can imagine. Last visit refers to the last visit that a participant completed the assessment.~Change in NRS constipation score was calculated as: Last Visit NRS constipation score - Randomization (Part B) Baseline NRS constipation score. The participant's Randomization (Part B) baseline constipation NRS value was the last evaluation (including unscheduled visits) in the single-blind treatment period (Part A) prior to the first dose of study drug in the double-blind treatment period (Part B). A negative value indicates improvement in condition from Randomization (Part B) Baseline."|Randomization Baseline, Last Visit (up to Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
2716045|NCT01128179|Secondary|Change From Baseline in Serum Phosphate Values at Week 12 (LOCF)||12 weeks|PP|||mmol/L||Standard Error|Least Squares Mean
2678256|NCT01424566|Secondary|Change From Randomization Baseline In Daily Break-through Opioid Dose (Morphine Equivalent) At End Of Treatment|"Daily break-through opioid dose usage was calculated as the product of prescribed dose per use, and the number of uses per day. If participants took more than 1 different break-through opioid for more than 1 day, the sum of morphine equivalence dose usages for each break-through opioid was calculated for the summary.~Change in daily break-through opioid dose was calculated as: End of Treatment daily break-through opioid dose - Randomization (Part B) Baseline daily maintenance opioid dose. The participant's Randomization (Part B) baseline daily break-through opioid dose value was the mean over the last 4 consecutive days of the single-blind treatment period (Part A; pre-randomization). A negative value indicates a decrease in dose from Randomization (Part B) Baseline."|Randomization Baseline, End of Treatment (Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||mg (morphine equivalent)||Standard Deviation|Mean
2678257|NCT01424566|Secondary|Change From Randomization Baseline In Daily Maintenance Opioid Dose (Morphine Equivalent) At End Of Treatment|"The prescribed daily quantity of opioid maintenance dose was calculated as the product of dose per use and daily frequency of use. Participants were asked: Have you used your maintenance dose painkiller today as prescribed? If the participant answered No to the question, the daily opioid maintenance dose usage on that day was set to 0.~Change in daily maintenance opioid dose was calculated as: End of Treatment daily maintenance opioid dose - Randomization (Part B) Baseline daily maintenance opioid dose. The participant's Randomization (Part B) baseline daily maintenance opioid dose value was the mean over the last 4 consecutive days of the single-blind treatment period (Part A; pre-randomization). A negative value indicates a decrease in dose from Randomization (Part B) Baseline."|Randomization Baseline, End of Treatment (Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||mg (morphine equivalent)||Standard Deviation|Mean
2678258|NCT01424566|Secondary|Change From Randomization Baseline In Daily Total Opioid Use (Morphine Equivalent) At End Of Treatment|"The total daily opioid use (in morphine equivalence) was the sum of morphine equivalence of daily maintenance dose and break-through dose.~Change in daily total opioid use was calculated as: End of Treatment daily total opioid use - Randomization (Part B) Baseline daily total opioid use. The participant's Randomization (Part B) baseline daily total opioid use value was the mean over the last 4 consecutive days of the single-blind treatment period (Part A; pre-randomization). A negative value indicates a decrease in use from Randomization (Part B) Baseline."|Randomization Baseline, End of Treatment (Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||mg (morphine equivalent)||Standard Deviation|Mean
2678259|NCT01424566|Secondary|Patient Satisfaction Questionnaire At Last Visit (Up To Day 36 Of The Double-blind Period)|"The Patient Satisfaction Questionnaire (PSQ) was used to assess level of satisfaction of the participant with the study drug, with the markers extremely satisfied, very satisfied, slightly satisfied, neutral, slightly dissatisfied, very dissatisfied, extremely dissatisfied. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36 of the double-blind period."|Last Visit (up to Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||Participants|||Count of Participants
2678260|NCT01424566|Secondary|Physician Global Impression Of Change At Last Visit (Up To Day 36 Of The Double-blind Period)|"The Physician Global Impression of Change (PGIC) was used by the treating physician (investigator/sub-investigator) to assess if there was any change in the general functional abilities of the participant since prior to commencement of study medication, with the markers: very much worse, much worse, slightly worse, no change, slightly improved, much improved, very much improved. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36 of the double-blind period."|Last Visit (up to Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||Participants|||Count of Participants
2678261|NCT01424566|Secondary|Subject Global Impression Of Change At Last Visit (Up To Day 36 Of The Double-blind Period)|"The Subject Global Impression of Change (SGIC) was used to assess the overall status of the participant related to their cancer pain, with the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse, or very much worse. The SGIC was assessed at Day 36 of the double-blind period or the day at which a participant's last evaluation was performed, such as in the case of early termination. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36 of the double-blind period."|Last Visit (up to Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||Participants|||Count of Participants
2678262|NCT01424566|Secondary|Change From Randomization Baseline In Mean Sleep Disruption NRS At End Of Treatment|"Participants indicated the level of sleep disruption experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated did not disrupt sleep and a score of 10 indicated completely disrupted (unable to sleep at all). Change in mean sleep disruption NRS was calculated as: End of Treatment sleep disruption NRS score - Randomization (Part B) Baseline sleep disruption NRS score. The participant's Randomization (Part B) baseline sleep disruption 0-10 NRS value was the mean over the last 4 consecutive days of the single-blind treatment period (Part A; pre-randomization). A negative value indicates an improvement in sleep disruption score from Randomization (Part B) Baseline."|Randomization Baseline, End of Treatment (Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
2719252|NCT01105650|Secondary|Number of Participants With Progressive Disease at One Year||1 Year||||Participants|||Count of Participants
2678263|NCT01424566|Secondary|Change From Randomization Baseline In Mean NRS Worst Pain At End Of Treatment|"Participants indicated the level of worst pain experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Change in mean NRS worst pain was calculated as: End of Treatment NRS worst pain score - Randomization (Part B) Baseline NRS worst pain score. The participant's Randomization (Part B) baseline worst pain 0-10 NRS value was the mean over the last 4 consecutive days of the single-blind treatment period (Part A; pre-randomization). A negative value indicates an improvement in worst pain score from Randomization (Part B) Baseline."|Randomization Baseline, End of Treatment (Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
2678264|NCT01424566|Secondary|Percent Improvement From Eligibility Baseline In Mean NRS Average Pain Score At End Of Treatment|"Participants indicated level of pain in the last 24 hours on an 11-point NRS, where a score of 0 was no pain and 10 was pain as bad as you can imagine. Eligibility Baseline = mean score from the 3-day eligibility period. End of Treatment = mean score over last (up to) 4 days to the final pain score at End of Treatment or up until Day 36 of the double-blind period, whichever is earlier, or final score available (prematurely terminated).~Percentage improvement from baseline (Imp%) was calculated as:~Imp% = (Eligibility Baseline pain NRS mean - End of Treatment pain NRS mean)/Eligibility Baseline pain NRS mean * 100.~For participants who died or withdrew due to disease progression, Imp% values were used. For participants who died or withdrew unrelated to disease progression before end of Week 5, Imp% was zero for participants whose Imp% value was positive and it was Imp% for participants whose Imp% value was not positive."|Eligibility Baseline, End of Treatment (Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||percent improvement||Inter-Quartile Range|Median
2678265|NCT01424566|Primary|Change From Randomization Baseline In Mean NRS Average Pain At End Of Treatment|"Participants indicated the level of pain experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Change in mean NRS average pain was calculated as: End of Treatment NRS average pain score - Randomization (Part B) Baseline NRS average pain score. The participant's Randomization (Part B) baseline pain 0-10 NRS value was the mean over the last 4 consecutive days of the single-blind treatment period (Part A; pre-randomization). A negative value indicates an improvement in average pain score from Randomization (Part B) Baseline."|Randomization Baseline, End of Treatment (Day 36 of the double-blind period)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
2678266|NCT01424514|Secondary|Number of Participants With Vital Sign of Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), HR and Body Temperature of PCI Abnormalities at Any Time During Treatment|The PCI values of vital signs were SBP: <85 and >160 millimetres of mercury (mmHg), DBP of <45 and >100 mmHg, HR of <40 and >110 beats per minute (bpm) and body temperature of <36 and >37.5oC.|Day 1 and Day 14 of each period|All Subjects Population.|||Participants|||Number
2678267|NCT01424514|Secondary|Number of Participants With Clinical Chemistry PCI Abnormalities of Creatinine, Blood Urea Nitrogen (BUN), Uric Acid, Cholesterol, Triglycerides, Lactate Dehydrogenase (LDH) and Liver Function Test at Any Time During Treatment|The PCI values of clinical chemistry parameters were creatinine: low- male is <75 micromoles per litre (mcmol/L); low- female is <65 mcmol/L; high- male >110 mcmol/L; high- female >95 mcmol/L, BUN: high is >1.5 x ULN millimole per litre (mmol/L), uric acid: low- male is <180 mcmol/L; low- female is <120 mcmol/L; high- male >480 mcmol/L; high- female >420 mcmol/L, cholesterol: low is <3.9 mmol/L; high is >6.5 mmol/L [if age <=40, if age >40- high is >6.55 mmol/L], triglycerides: low- <0.5 mmol/L; high- >2.0 mmol/L, LDH: >220 units per lire (U/L). For high alanine aminotransferase (ALT); aspartate aminotransferase (AST); alkaline phosphatase is >=2 x ULN U/L. Total bilirubin high is >=1.5 x ULN mcmol/L, gamma glutamyltransferase (GGT) high: male- >60 U/L; female > 40 U/L.|Day 14 of each period|All Subjects Population.|||Participants|||Number
2678268|NCT01424514|Secondary|Number of Participants With Clinical Chemistry PCI Abnormalities of Albumin, Calcium, Glucose, Potassium, Sodium and Total Carbon Dioxide (CO2) at Any Time During Treatment|The PCI values of albumin, calcium, glucose, potassium, sodium and total CO2 were obtained by multiplying a fixed factor to the site's upper or lower limit normal ranges for each of the parameter. The factors were albumin (relative low): 0.86, calcium: 0.91 for relative low; 1.06 for relative high, glucose: 0.71 for relative low; 1.41 for relative high, potassium: 0.86 for relative low; 1.10 for relative high, sodium: 0.96 for relative low; 1.03 for relative high and total CO2: 0.86 for relative low; 1. 14 for relative high.|Day 14 of each period|All Subjects Population.|||Participants|||Number
2678269|NCT01424514|Secondary|Number of Participants With Haematology Abnormalities of Potential Clinical Importance (PCI) at Any Time During Treatment|The PCI values of hematology parameters were obtained by multiplying a fixed factor to the site's upper or lower limit normal ranges for each of the parameter. The factors were white blood cell count (WBC): 0.67 for relative low; 1.82 for relative high, haemoglobin (Hb) relative high: male - 1.03; female - 1.13, haematocrit (relative high): male - 1.02; female - 1.17, platelets: 0.67 for relative low; 1.57 for relative high, neutrophils (relative low): 0.83, lymphocytes (relative low): 0.81.|Day 14 of each period|All Subjects Population.|||Participants|||Number
2678270|NCT01424514|Secondary|Number of Participants With Abnormal (Both Not Clinically Significant and Clinically Significant) Electrocardiogram (ECG) Findings|ECGs were obtained on Day 1 (pre-dose) and Day 14 (pre- dose) of each period. Single 12-lead ECGs was obtained at each timepoint during the study using an ECG machine that automatically calculated the heart rate (HR) and measures PR, QRS, QT, and QTc intervals. Participants with abnormal (not clinically significant), abnormal (clinically significant) and no result were presented.|Day 1 (pre-dose) and Day 14 (pre-dose)|All Subjects Population.|||Participants|||Number
2678333|NCT01424306|Primary|Fasting Plasma Interleukin-6 on Day 9 of Each Diet Period|The concentration of interleukin-6 in fasting plasma will be measured by high-sensitivity enzyme-linked immunosorbent assay at the end (day 9) of each 8-day dietary period.|End (day 9) of each diet period|All completed participants combined in per protocol analysis|||pg/mL||Inter-Quartile Range|Median
2678271|NCT01424514|Secondary|Number of Participants With Any Adverse Event (AE), Serious Adverse Event or Drug-related AE|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalised ratio >1.5. AEs were classified as potentially drug-related, based on the investigator's judgement.|Start of study treatment (Day 1 of first period) up to follow up, for up to 28 days.|All Subjects Population.|||Participants|||Number
2678272|NCT01424514|Secondary|Pharmacokinetic Parameter of Time to Maximum Observed Plasma Concentration (Tmax) on Day 1 and 14|Blood samples for pharmacokinetic assessment were collected at pre-dose (0 h), 1, 2, 3 and 24 h post-dose on Day 1 and Day 14 of each period. Tmax was determined directly from the raw concentration-time data on Day 1 and Day 14 where, NQs were imputed to zero or missing and lower limit of quantification is 2.5 ng /mL. Analysis was done on the number of participants with non-missing observations (including imputed NC values)|Pre-dose (0 h), 1, 2, 3 and 24 h post-dose on Day 1 and Day 14 of each period.|Pharmacokinetic Population.|||h||Full Range|Median
2678273|NCT01424514|Secondary|Pharmacokinetic Parameter of Maximum Observed Plasma Concentration (Cmax) on Day 1 and 14|Blood samples for pharmacokinetic assessment were collected at pre-dose (0 h), 1, 2, 3 and 24 h post-dose on Day 1 and Day 14 of each period. The first occurrence of Cmax was determined directly from the raw concentration-time data on Day 1 and Day 14 where, NQs were imputed to zero or missing and lower limit of quantification was 2.5 nanogram per millilitre (ng /mL). Logarithmically transformed data is reported for Cmax. CVb (%) was calculated as, CVb (%) = SQRT (exp [SD2-1]) x 100, where SD is the standard deviation of the logarithmically transformed data. Analysis was done on the number of participants with non-missing observations (including imputed NC values).|Pre-dose (0 h), 1, 2, 3 and 24 h post-dose on Day 1 and Day 14 of each period.|Pharmacokinetic population.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2678274|NCT01424514|Secondary|Pharmacokinetic Parameter of Area Under the Plasma Concentration-time Curves From Time Zero (Pre- Dose) to 3 h and 24 h (t) on Day 1 and Day 14 (AUC [0-3], AUC [0-t])|Blood samples for pharmacokinetic assessment were collected at pre-dose (0 h), 1, 2, 3 and 24 h post-dose on Day 1 and Day 14 of each period. The area under the plasma concentration-time curves from time zero (pre- dose) to 3 h, AUC (0-3) and the last quantifiable concentration, AUC (0-t) (24 h) was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. The AUC of non-calculable (NC) due to non-quantifiable concentration measured as below lower limit of quantification (NQ) values were imputed by 0.5 x lowest observed AUC (i.e., AUC [0-3]: 0.5 x 6.4; AUC[0-t]: 0.5 x 6.3). Coefficient of variation (CVb [%]) was calculated as, CVb (%) = SQRT (exp [SD2-1]) x 100, where SQRT is the square root, exp is the exponent and SD is the standard deviation of the logarithmically transformed data. Analysis was done on the number of participants with non-missing observations (including imputed NC values).|Pre-dose (0 h), 1, 2, 3 and 24 h post-dose on Day 1 and Day 14 of each period.|Analysis was done on Pharmacokinetic Population, defined as participants in the ‘All Subjects’ population for whom a pharmacokinetic sample was obtained and analysed. Imputed NC values were derived for AUC (0-3), on Day 1 for 3 participants and for AUC (0-t) on Day 1 for 2 participants.|||Nanogram × hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2678275|NCT01424514|Secondary|Mean Total Ocular Symptom Score (TOSS; Red, Itchy and Tearing Eyes) Elicited by a 1 h CDA Challenge at 1 h Post-dose on Day 1, 1 and 24 h Post-dose on Day 14 to Compare the Effect of Intranasal SB-705498 12 mg Compared With Placebo|The assessment of TOSS was done based on a CDA challenge, for 1 h in a controlled environmental exposure chamber which was validated for 14+/-5 degree C, <15% relative humidity and 5+/-3 ft/sec air velocity, 1 h post dose on Day 1 and 1 h and 24 h post dose on Day 14 (Day 15). TOSS was calculated as the sum of the symptom scores for 3 ocular symptoms of itching/burning eyes, tearing/watering eyes, and redness of eyes. It was rated on a 4-point severity scale ranging from 0 to 3, where: 0=absent, 1=mild, 2=moderate and 3=severe (symptom hard to tolerate, interferes with daily activities/sleeping). TOSS score ranges from 0-9 with 0 representing an absence of symptoms and 9 representing severe symptoms. These values were used to derive the WM (s) of the CDA challenge value and the maximum score. WM is reported as LS mean.|Day 1 and 15 of each period (Day 14, 24 h post- dose was assessed on Day 15)|All Subjects Population. Only those participants available at the specified time points was analyzed.|||Scores on scale||Standard Error|Least Squares Mean
2678276|NCT01424514|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Following Repeat Doses of SB-705498 on Day 14|The RQLQ is a 28-item, disease-specific quality of life questionnaire that measures the functional (physical, emotional, and social) problems troublesome to adults with allergies. The RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms and emotional). All 28 questions were evaluated by the participant in an assessment diary over 2 weeks of treatment period and was rated on a 7-point severity scale ranging from 0 to 6, where 0=least severe to 6=extremely severe. Overall mean was calculated by summing all 28-item scores and dividing by total number of items in the questionnaire. RQLQ score ranges from 0-6 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. Baseline was defined as the value on Day 1 pre- dose. Change from baseline was calculated by subtracting baseline (Day 1 pre-dose) values from individual post-randomization values. Adjusted mean is reported as LS mean.|Baseline (Day 1 pre-dose) and Day 14 of each period|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Error|Least Squares Mean
2678330|NCT01424306|Secondary|Intestinal Permeability, as Assessed by the 5-hour Urinary Lactulose/Mannitol Test|Intestinal permeability will be assessed on day 9 of each diet period by administering a beverage containing 2 g of mannitol and 5 g of lactulose followed by collecting urine for 5 hours afterwards. Recovery of mannitol and lactulose in urine will be measured by gas chromatography, and will be indicative of the degree of intestinal permeability.|End (day 9) of each diet period.|All completed participants combined in per protocol analysis|||ratio||Inter-Quartile Range|Median
2678277|NCT01424514|Secondary|Mean Change From Baseline to Day 14 of Acoustic Rhinometry (AR) Following Repeat Dosing of SB-705498 at 2 h and 25 h Post-dose|Overall AR score was obtained by adding minimal cross-sectional area (MCA) for right and left nostril. MCA1 was captured within the nose at a distance of 0 and 2.2 cm and MCA2 at 2.2 and 5.5 cm. MCA1 and MCA2 were captured simultaneously for each nostril, 3 measurements were obtained from each nostril which resulted in 12 data points. Absolute MCA for all regions in left or right nostril was calculated using the 3 acceptable measurements, calculating average of each of right and left MCA's and also by selecting minimum value from these averages to obtain minimum MCA for left and right nostril. Baseline is defined as the value on Day 1 pre- dose. Change from baseline was calculated by subtracting the baseline (Day 1 pre-dose) values from individual post-randomization values done immediately following CDA challenge. In case of missing baseline or post randomization value, the change from baseline was set to be missing. Adjusted mean is reported as LS mean.|Baseline (Day 1 pre-dose), Day 14 and Day 15 of each period (Day 14, 25 h post dose on Day 14 was evaluated on Day 15)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Centimetre square (cm^2)||Standard Error|Least Squares Mean
2678278|NCT01424514|Secondary|Mean Sneezing Elicited by a 1 h CDA Challenge at 1 h Post-dose on Day 1, 1 and 24 h Post-dose on Day 14 to Compare the Effect of Intranasal SB-705498 12 mg With Placebo|The assessment of sneezing was done based on a CDA challenge, for 1 h in a controlled environmental exposure chamber which was validated for 14+/-5 degree C, <15% relative humidity and 5+/-3 ft/sec air velocity, 1 h post dose on Day 1 and 1 h and 24 h post dose on Day 14 (Day 15). Sneezing was scored on a 4-point scale ranging from 0 to 3, where: 0=absent, 1=mild, 2=moderate, and 3=severe (symptom hard to tolerate). The score ranges from 0-3 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. It was used to derive the WM CDA challenge value calculated over the time interval 0 to 60 m after start of CDA challenge and the maximum score. WM is reported as LS mean.|Day 1, Day 14 and Day 15 of each period (Day 14, 24 h post- dose was done on Day 15)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Error|Least Squares Mean
2678279|NCT01424514|Secondary|Mean Individual Component of TSS of Rhinorrhoea (Runny Nose), Nasal Congestion and Post-nasal Drip From Day 7 to Day 14 Following Repeat Doses of SB-705498|The individual component of TSS nasal symptoms of nasal congestion, rhinorrhoea (runny nose) and post nasal drip was scored on a 4-point scale ranging from 0 to 3, where: 0=absent, 1=mild, 2=moderate, and 3=severe (symptom hard to tolerate). The scores of the individual components of TSS ranges from 0-3 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. For Day 1 to 14 of each study period, participants were asked to keep a diary to record their symptoms whilst at home on a diary card provided by the clinical unit. Reflective rating represented the symptoms over the proceeding 12 h which was performed once daily in the PM. The PM reflective rating was done approximately 12 h after dosing, but before bedtime.|Day 7 to Day 14 of each period|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Deviation|Mean
2678280|NCT01424514|Secondary|Mean TSS From Day 7 to Day 14 (Post-dose Prior to Challenge) Following Repeat Doses of SB-705498|TSS was calculated as the sum of the response for 3 components of nasal congestion, rhinorrhoea and post nasal drip. It was rated on a 4-point scale ranging from 0 to 3, where: 0=absent, 1=mild, 2=moderate, and 3=severe (symptom hard to tolerate). TSS score ranges from 0-9 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. For Day 1 to 14 of each study period, participants were asked to keep a diary to record their symptoms whilst at home provided by the clinical unit. Reflective rating represented the symptoms over the proceeding 12 h which was performed once daily in the evening (PM). The PM reflective rating was done approximately 12 h after dosing, but before bedtime. If any of the individual components were missing then the TSS was set to be missing for that participant at that timepoint.|Day 7 to Day 14 of each period|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Deviation|Mean
2678281|NCT01424514|Secondary|Mean Individual Component of TSS of Rhinorrhoea (Runny Nose), Nasal Congestion and Post-nasal Drip Elicited by a 1 h CDA Challenge, 1 h Post-dose on Day 1 to Compare the Effect of a Single Dose of 12 mg Intranasal SB-705498 With Placebo|The individual components of TSS was calculated based on a CDA challenge, done for 1 h in a controlled environmental exposure chamber which was validated for 14+/-5 degree C, <15% relative humidity and 5+/-3 ft/sec air velocity, 1 h and 24 h post dose on Day 1. The individual component of TSS nasal symptoms were nasal congestion, rhinorrhoea (runny nose), and post nasal drip It was rated on a 4-point scale ranging from 0 to 3, where: 0=absent, 1=mild, 2=moderate, and 3=severe (symptom hard to tolerate). The score ranges from 0-3 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. WM for TSS was calculated over the time interval 0 to 60 m after start of CDA challenge by calculating AUC of the TSS via the linear trapezoidal method then dividing by the total duration that the participant took to complete CDA challenge assessments. WM is reported as LS mean.|Day 1 of each period|All Subjects Population.|||Scores on scale||Standard Deviation|Mean
2678282|NCT01424514|Secondary|Mean Total Symptom Score (TSS) Elicited by a 1 Hour (h) CDA Challenge, 1 h Post-dose on Day 1 to Compare the Effect of a Single Dose of 12 mg Intranasal SB-705498 With Placebo|TSS was calculated based on a CDA challenge, done for 1 h in a controlled environmental exposure chamber which was validated for 14+/-5 degree C, <15% relative humidity and 5+/-3 ft/sec air velocity, 1 h and 24 h post dose on Day 1. TSS was calculated as the sum of the response for 3 components of nasal congestion, rhinorrhoea and post nasal drip. It was rated on a 4-point scale ranging from 0 to 3, where: 0=absent, 1=mild, 2=moderate, and 3=severe (symptom hard to tolerate). TSS score ranges from 0-9 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. WM for TSS was calculated over the time interval 0 to 60 m after start of CDA challenge by calculating AUC of the TSS via the linear trapezoidal method then dividing by the total duration that the participant took to complete CDA challenge assessments. WM is reported as LS mean.|Day 1 of each period|All Subjects Population.|||Scores on scale||Standard Error|Least Squares Mean
2678331|NCT01424306|Secondary|Mean Daily Calorie Intake|Mean daily calorie intake will be assessed during each of the three 8-day diet periods. All foods will be provided to the subjects in excess of what they are estimated to require, and calorie intake will be assessed by subtracting returned foods from foods administered.|The mean daily calorie intake during each of the 8-day diet periods will be calculated.|All completed participants combined in per protocol analysis|||kcal/d||Standard Deviation|Mean
2678283|NCT01424514|Primary|Mean Individual Component of TSS of Rhinorrhoea (Runny Nose), Nasal Congestion and Post-nasal Drip Elicited by a 1 h CDA Challenge, 1 h and 24 h on Day 14 to Compare the Effect of 14 Day Repeat Dosing of Intranasal SB-705498 12 mg With Placebo|The individual components of TSS was calculated based on a CDA challenge, done for 1 h in a controlled environmental exposure chamber which was validated for 14+/-5 degree C, <15% relative humidity and 5+/-3 ft/sec air velocity, 1 h and 24 h post dose on Day 14 (Day 15). The individual component of TSS nasal symptoms were nasal congestion, rhinorrhoea (runny nose), and post nasal drip It was rated on a 4-point scale ranging from 0 to 3, where: 0=absent, 1=mild, 2=moderate, and 3=severe (symptom hard to tolerate). The scores of the individual components of TSS ranges from 0-3 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. WM for TSS was calculated over the time interval 0 to 60 m after start of CDA challenge by calculating AUC of the TSS via the linear trapezoidal method then dividing by the total duration that the participant took to complete CDA challenge assessments. WM is reported as LS mean.|Day 14 to Day 15 of each period (Day 14, 24 h post- dose was done on Day 15)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2678284|NCT01424514|Primary|Mean Total Symptom Score (TSS) Elicited by a 1 Hour (h) Cold Dry Air (CDA) Challenge, 1 h and 24 h on Day 14 to Compare the Effect of 14 Day Repeat Dosing of Intranasal SB-705498 12 mg With Placebo|TSS was calculated based on a CDA challenge, done for 1 h in a controlled environmental exposure chamber which was validated for 14+/-5 degree Celsius (C), <15% relative humidity and 5+/-3 feet per second (ft/sec) air velocity, 1 h and 24 h post dose on Day 14 (Day 15). TSS was calculated as the sum of the response for 3 components of nasal congestion, rhinorrhoea and post nasal drip. It was rated on a 4-point scale ranging from 0 to 3, where: 0=absent, 1=mild, 2=moderate, and 3=severe (symptom hard to tolerate). TSS score ranges from 0-9 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. Weighted mean (WM) for TSS was calculated over the time interval 0 to 60 minute (m) after start of CDA challenge by calculating area under the curve (AUC) of the TSS via the linear trapezoidal method then dividing by the total duration that the participant took to complete CDA challenge assessments. WM is reported as least square (LS) mean.|Day 14 to Day 15 of each period (Day 14, 24 h post- dose was done on Day 15)|All Subjects population defined as all participants who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.|||Scores on scale||Standard Error|Least Squares Mean
2678285|NCT01424501|Secondary|Frequency of CD8+ T-cells M72-specific Expressing Immune Markers in Any Combination|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
2678286|NCT01424501|Secondary|Frequency of CD8+ T-cells M72-specific Expressing Cytokines in Any Combination|Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
2678287|NCT01424501|Secondary|Frequency of M72-specific CD8+ T-cells Expressing Immune Markers in Any Combination|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
2678288|NCT01424501|Secondary|Frequency of M72-specific CD8+ T-cells Expressing Cytokines in Any Combination|Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
2678289|NCT01424501|Secondary|Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Cytokines|Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
2678290|NCT01424501|Secondary|Frequency of CD8+ T-cells M72-specific Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
2679498|NCT01410604|Primary|High-sensitivity C-reactive Protein|Change from baseline in High-sensitivity C-reactive protein after 3 months of treatment.|baseline and 3 months||||mg/dL||Standard Deviation|Mean
2678291|NCT01424501|Secondary|Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Cytokines|Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
2678292|NCT01424501|Secondary|Frequency of M72-specific CD8+ T-cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
2678293|NCT01424501|Secondary|Frequency of M72-specific CD8+ T-cells Expressing at Least 2 Immune Markers Among 6|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a), CD40-ligand (CD40-L), Interleukin-17 (IL-17) and/or Interleukin-13 (IL-13).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
2678294|NCT01424501|Secondary|Frequency of M72-specific Cluster of Differentiation 8 (CD8+) T-cells Expressing at Least 2 Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD8+ T-cells/million cells||Inter-Quartile Range|Median
2678295|NCT01424501|Secondary|Frequency of CD4+ T-cells M72-specific Expressing Immune Markers in Any Combination|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
2678296|NCT01424501|Secondary|Frequency of CD4+ T-cells M72-specific Expressing Cytokines in Any Combination|Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
2678297|NCT01424501|Secondary|Frequency of M72-specific CD4+ T-cells Expressing Immune Markers in Any Combination|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
2678298|NCT01424501|Secondary|Frequency of M72-specific CD4+ T-cells Expressing Cytokines in Any Combination|Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
2678299|NCT01424501|Secondary|Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
2678300|NCT01424501|Secondary|Frequency of CD4+ T-cells M72-specific Expressing Any Combination of Cytokines|Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
2678301|NCT01424501|Secondary|Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
2678302|NCT01424501|Secondary|Frequency of M72-specific CD4+ T-cells Expressing Any Combination of Cytokines|Immune markers (cytokines) expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
2678303|NCT01424501|Secondary|Frequency of M72-specific CD4+ T-cells Expressing at Least 2 Immune Markers Among 6|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a), CD40-ligand (CD40-L), Interleukin-17 (IL-17) and/or Interleukin-13 (IL-13).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
2678304|NCT01424501|Secondary|Frequency of M72-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing Any Combination of the Different Immune Markers|Immune markers expressed were among Interleukin-2 (IL-2), Interferon-gamma (IFN-g), Tumour necrosis factor-alpha (TNF-a) and/or CD40-ligand (CD40-L).|Prior to dose 1 (Day 0), post-dose 1 (Days 7 and 30), post-dose 2 (Days 37, 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||CD4+ T-cells/million cells||Inter-Quartile Range|Median
2678305|NCT01424501|Secondary|Concentrations of Anti-M72 Antibodies|Concentrations are presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EU/mL).|Prior to dose 1 (Day 0), post-dose 1 (Day 30), post-dose 2 (Days 60 and 210)|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules, receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||EU/mL||95% Confidence Interval|Geometric Mean
2678306|NCT01424501|Secondary|Number of Subjects With Anti-Mycobacterium Tuberculosis Fusion Protein M72 Antibodies|Cut-off values assessed were greater than or equal to (≥) 2.8, as measured by Enzyme-Linked Immunosorbent Assay (ELISA) in the sera of subjects seronegative before vaccination.|Prior to dose 1 (Day 0), post-dose 1 (Day 30), post-dose 2 (Days 60 and 210)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity,which included all evaluable subjects who met all eligibility criteria and complied with vaccination and blood sampling schedules,receiving a complete vaccination program or if not, they did not have blood samples taken after the interruption of the vaccination.|||Participants|||Count of Participants
2678307|NCT01424501|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Up to day 210|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and for whom data were available.|||Subjects|||Number
2678308|NCT01424501|Primary|Number of Subjects With Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|During the 30 day (Days 0-29), after vaccination|The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered and for whom data were available.|||Subjects|||Number
2678309|NCT01424501|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, malaise, myalgia and temperature [body temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any solicited general symptom regardless of their intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = body temperature above (>) 39.5°C. Related = event assessed by the investigator as causally related to the study vaccination.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administered, for whom data were available and who had their symptoms sheets filled in.|||Participants|||Count of Participants
2678310|NCT01424501|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities. Grade 3 redness/swelling = redness/swelling spreading beyond (>) 100 millimeters (mm) of injection site.|During the 7-day (Days 0-6) post-vaccination period following each dose and across doses|The analysis was performed on the Total Vaccinated cohort, which included all subjects with study vaccine administered, for whom data were available and who had their symptom sheets filled in.|||Participants|||Count of Participants
2678332|NCT01424306|Secondary|Fasting Plasma Adiponectin|The concentration of adiponectin in fasting plasma will be measured by enzyme-linked immunosorbent assay at the end (day 9) of each 8-day dietary period.|End (day 9) of each diet period.|All completed participants combined in per protocol analysis|||ng/mL||Standard Deviation|Mean
2678311|NCT01424397|Secondary|Number of Participants With Clinical Biochemistry Parameters of PCI|The PCC range for clinical chemistry parameters included albumin, low: 0.86, millimole per liter (mmol)/L, calcium, low: 0.91, high: 1.06, glucose. Low: 0.71, high: 1.41, Potassium, low: 0.86, high: 1.10, Sodium, low: 0.96, high: 1.03, Total CO2, Low: 0.86, high: 1.14, Creatinine, in male, Low: <75 micromole per liter (μmol/L), high: >110 μmol/L, female, Low: <65 μmol/L, high: >95, Blood Urea Nitrogen (BUN), high: >1.5xULN mmol/L, Uric Acid, in male, Low: < 180 μmol/L, high: > 480 μmol/L, female, Low: < 120 μmol/L, high: > 420. Only parameters with PCI values are reported.|Up to Week 16|All subjects population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2678312|NCT01424397|Secondary|Number of Participants With Hematology Parameters of PCI|The PCC range for hematology parameters included white blood cell count, low: 0.67, high 1.82, neutrophil count, low: 0.83, Hemoglobin, male- high 1.03, female- high 1.13, hematocrit, male- high 1.02, female- high 1.17, Platelet Count, low: 0.67, high: 1.57, lymphocytes, low 0.81. Only parameters with PCI values are reported.|Up to Week 16|All subjects population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2678313|NCT01424397|Secondary|Change From Baseline in ECG Values: PR Interval, QRS Duration, QT Interval, QTcB, QTcF|Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated heart rate and measured PQ, QRS, QT, QTc corrected by Bazett's formula (QTcB) and QTc corrected by Fridericia's formula (QTcF). Baseline was assessment on Day 1. Change from Baseline was the values at specified time points subtracted by the Baseline value.|Baseline and Day 8 of each treatment period|All subjects population. Only those participants available at the indicated time points were analyzed.|||Milliseconds (msec)||Standard Deviation|Mean
2678314|NCT01424397|Secondary|Change From Baseline in ECG Values: Heart Rate|Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated heart rate and measured PQ, QRS, QT, and QTc intervals. Baseline was assessment on Day 1. Change from Baseline was the values at specified time points subtracted by the Baseline value.|Baseline and Day 8 of each treatment period|All subjects population. Only those participants available at the indicated time points were analyzed.|||beats per minute (bpm)||Standard Deviation|Mean
2678315|NCT01424397|Secondary|Number of Participants With Vital Signs of Potential Clinical Importance (PCI)|Vital signs assessment included heart rate, blood pressure, and temperature. Criteria for vital sign values meeting potential clinical concern included: systolic blood pressure (SBP) <85 and >160 millimeters of mercury (mm Hg), diastolic blood pressure (DBP) < 45 and > 100 mm Hg, temperature <36 and >37.5 Degree Celsius and heart Rate <40 and >110 beats per minute. Only parameters with PCI values are reported.|Up to Week 16|All Subjects population. Only those participants available at the indicated time points were analyzed.|||Participants|||Count of Participants
2678316|NCT01424397|Secondary|Maximum Observed Concentration (Cmax) for SB-705498 on Day 8|Plasma samples for pharmacokinetic analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified. Values were reported as least squares geometric means with respective geometric coefficient of variation (% CV).|Period 1: Day 1 (post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h), Period 2 and 3: Day 1 (Pre-dose 0.0 h, post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h)|Pharmacokinetic Population. Only those participants available at the indicated time points were analyzed.|||nanograms per mililiter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2678317|NCT01424397|Secondary|Area Under Concentration-time Curve (AUC) for SB-705498 on Day 8|Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. AUC0-t was calculated by the linear trapezoidal method. AUC0-infinity was calculated as the sum of the AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant, where first-order elimination or terminal rate constant was calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations. Values were reported as Least Squares Geometric Means with respective % CV.|Period 1: Day 1 (post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h), Period 2 and 3: Day 1 (Pre-dose 0.0 h, post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h)|The ‘Pharmacokinetic Population' is defined as participants in the ‘All Subjects’ population for whom a pharmacokinetic sample was obtained and analyzed. Only those participants available at the indicated time points were analyzed.|||nanograms*hour per mililiter (ng.h/mL)||Geometric Coefficient of Variation|Geometric Mean
2678318|NCT01424397|Secondary|Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Following Repeat Doses of SB-705498 or or SB-705498 Matching Placebo|The RQLQ composed of 28 items covering 7 domains of health. Each question is scored on a scale of 0 to 6 (where, 0 = not troubled and 6 = extremely troubled). 7 domains were: Activities (3 items):1, 2, 3;Sleep (3 items): 4, 5, 6; Non-nose/eye symptoms (7 items): 7, 8, 9, 10, 11, 12, 13; Practical Problems (3 items): 14, 15, 16; Nasal Symptoms (4 items): 17, 18, 19, 20; Eye Symptoms (4 items): 21, 22, 23, 24; Emotional (4 items): 25, 26, 27, 28 consisted of total 28 items. Domain activity score = total post-baseline score for individualized activity items answered on both visits divided by total Baseline score for individualized activity items answered on both visits multiplied by the Baseline score for item(s) missing post-baseline. The global RQLQ score was calculated by averaging all 28 item scores, which ranges from 0 to 6 (where, 0 = not troubled and 6 = extremely troubled). Higher scores indicate worsening of symptoms.|Day 8|All subjects population. Only those participants available at the indicated time points were analyzed.|||Score on a scale||Standard Error|Least Squares Mean
2678327|NCT01424306|Secondary|Adipose Tissue Inflammation - Tissue Expression of TNF-alpha mRNA|A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of TNF-alpha mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.|End (day 9) of each diet period.|A subset of the study population opted to undergo voluntary adipose tissue biopsy|||copy number/ng total RNA||Standard Deviation|Mean
2679499|NCT01410604|Primary|Adiponectin|Change from baseline in Adiponectin after 3 months of treatment.|baseline and 3 months||||µg/mL||Standard Deviation|Mean
2678319|NCT01424397|Secondary|Total Nasal Airflow on Day 8 Measured Using Active Anterior Rhinomanometry (AAR)|Total Nasal Airflow is calculated as the sum of the left nostril and the right nostril airflow values. AAR is a very sensitive method of assessing clinical parameters of nasal obstruction (nasal flow, nasal resistance and nasal flow increase). A participant was instructed to breathe through one nostril while a sensor in the other nostril measured the difference in pre-nasal and choanal pressure. The system was connected to a computer. Nasal flow and nasal resistance were observed at pressure levels of 75, 150 and 300 Pascal. The defined measuring range for the flow was +-1000 milliliter per second (mL/s). Weighted means for total nasal airflow Resistance was calculated by dividing the area under the curve between 1 and 4 hours (via the linear trapezoidal method) by the total duration that the participant took to complete the chamber challenge assessments.|Day 8|All subjects population. Only those participants available at the indicated time points were analyzed.|||Milliliters per second (mL/s)||Standard Error|Least Squares Mean
2678320|NCT01424397|Secondary|Mean TNSS and Its Individual Components From Day 4 to Day 8|Nasal symptoms (nasal congestion, rhinorrhoea, itching and sneezing) were scored on a scale from 0 to 3 where 0= absent symptoms, 3 = severe symptoms. TNSS was calculated as the sum of the response for all 4 individual nasal symptom scores. TNSS ranged from 0 to 12, where 0=absent symptoms, 3=severe symptoms. Higher the score, more severe the symptoms. Mean of TNSS and its individual components is presented pre-evening (pm) dose on Days 4, 5, 6, 7 and pre-challenge [1 hour (hr)] on Day 8.|pre-evening (pm) dose on Days 4, 5, 6, 7 and pre-challenge [1 hour (hr)] on Day 8 of each treatment period|All subjects population. Only those participants available at the indicated time points were analyzed.|||Score on a scale||Standard Deviation|Mean
2678321|NCT01424397|Primary|Mean Total Nasal Symptom Score (TNSS) and Its Individual Components on Day 8|Nasal symptoms (nasal congestion, rhinorrhoea, itching and sneezing) were scored on a scale from 0 to 3 where 0= absent symptoms, 3 = severe symptoms. TNSS was calculated as the sum of the response for all 4 individual nasal symptom scores. TNSS ranged from 0 to 12, where 0=absent symptoms, 3=severe symptoms. Higher the score, more severe the symptoms. Weighted mean (WM) of TNSS and its individual components (nasal congestion, rhinorrhoea, itching and sneezing) are presented on Day 8. Weighted mean was calculated over the time interval 0 to 4 hours after start of allergen chamber challenge by calculating the area under the curve of TNSS/component from time of the first observation to time of the last observation (AUC [tf-t1 hours]) using the trapezoidal rule, and then dividing by the actual relevant time interval (tf-t1) required by participant to complete the chamber challenge assessments. A Bayesian analysis was conducted to derive the posterior probability for TNSS.|Day 8 of each treatment period|All subjects population. Only those participants available at the specified time points were analyzed.|||Score on scale||Standard Deviation|Mean
2678322|NCT01424306|Secondary|Adipose Tissue Inflammation - Tissue Expression of IFN-gamma mRNA|A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of IFN-gamma mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.|End (day 9) of each diet period.|A subset of the study population opted to undergo voluntary adipose tissue biopsy|||copy number/ng total RNA||Inter-Quartile Range|Median
2678323|NCT01424306|Secondary|Adipose Tissue Inflammation - Tissue Expression of CCL2 mRNA|A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of CCL2 mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.|End (day 9) of each diet period.|A subset of the study population opted to undergo voluntary adipose tissue biopsy|||copy number/ng total RNA||Inter-Quartile Range|Median
2678324|NCT01424306|Secondary|Adipose Tissue Inflammation - Tissue Expression of IL-10 mRNA|A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of IL-10 mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.|End (day 9) of each diet period.|A subset of the study population opted to undergo voluntary adipose tissue biopsy|||copy number/ng total RNA||Inter-Quartile Range|Median
2678325|NCT01424306|Secondary|Adipose Tissue Inflammation - Tissue Expression of IL-6 mRNA|A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of IL-6 mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.|End (day 9) of each diet period.|A subset of the study population opted to undergo voluntary adipose tissue biopsy|||copy number/ng total RNA||Inter-Quartile Range|Median
2678326|NCT01424306|Secondary|Adipose Tissue Inflammation - Tissue Expression of IL-1beta mRNA|A subgroup of the study population will be enrolled into an ancillary study that will aim to assess the effects of consuming fructose- vs. high-fructose corn syrup- vs. glucose-sweetened beverages on adipose tissue inflammation. Adipose tissue inflammation will be assessed by whole adipose tissue gene expression analysis of IL-1beta mRNA. Abdominal subcutaneous adipose tissue samples will be obtained from subjects enrolled into the ancillary study by needle aspiration biopsy on day 9 of each 8-day dietary period.|End (day 9) of each diet period.|A subset of the study population opted to undergo voluntary adipose tissue biopsy|||copy number/ng total RNA||Inter-Quartile Range|Median
2678328|NCT01424306|Secondary|Fasting Plasma Lipopolysaccharide-binding Protein (LBP)|Lipopolysaccharide-binding protein (LBP) will be measured by enzyme-linked immunosorbent assay in fasting plasma collected on day 9 of each diet period. LBP is an acute phase protein secreted by the liver in response to endotoxin (lipopolysaccharide) exposure.|End (day 9) of each diet period.|All completed participants combined for protocol analysis|||ug/mL||Inter-Quartile Range|Median
2678334|NCT01424306|Primary|Fasting Plasma C-reactive Protein|The concentration of C-reactive protein in fasting plasma will be measured by high-sensitivity assay at the beginning (day 1) and end (day 9) of each 8-day dietary period.|Beginning (day 1) and end (day 9) of each diet period.|All completed participants combined in per protocol analysis|||mg/L||Inter-Quartile Range|Median
2678335|NCT01424228|Secondary|Change From Baseline in the Short Form-36 Health Survey (SF-36) Score at Up to the Final On Treatment Assessment Value|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Total score ranges from 0 (lowest level of health) - 100 (highest level of health) on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability (i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). Higher scores are associated with better quality of life.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||units on a scale||Standard Deviation|Mean
2678336|NCT01424228|Secondary|Change From Baseline in the Patient Assessment of Constipation - Quality of Life (PAC-QOL) Score at Up to the Final On Treatment Assessment Value|The PAC-QOL is a validated 28-item questionnaire for the evaluation of quality of life in subjects with constipation. Items are rated on a 5-point Likert scale: 0=not at all/none of the time, 1=a little bit/a little bit of the time, 2=moderately/some of the time, 3=quite a bit/most of the time, 4=extremely/all of the time. Total score ranges from 0-112. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-QOL total score was considered clinically meaningful.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||units on a scale||Standard Deviation|Mean
2678337|NCT01424228|Secondary|Change From Baseline in the Patient Assessment of Constipation - Symptom (PAC-SYM) Questionnaire Score at Up to the Final On Treatment Assessment Value|The PAC-SYM is a validated 12-item questionnaire for the evaluation of severity of symptoms of constipation in subjects with constipation. Items are rated on a 5-point Likert scale: 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. Total score ranges from 0 to 48. Lower scores indicate improvement in symptoms. A 1-point improvement in PAC-SYM total score was considered clinically meaningful.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||units on a scale||Standard Deviation|Mean
2678338|NCT01424228|Secondary|Change From Baseline in the Number of Days With Rescue Medication Taken Per Week at Up to 24 Weeks|Rescue medications include laxatives and enemas.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||days/week||Standard Deviation|Mean
2678339|NCT01424228|Secondary|Change From Baseline in the Number of Bisacodyl Tablets Taken Per Week at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||tablets/week||Standard Deviation|Mean
2678340|NCT01424228|Secondary|Time to First SCBM After Investigational Product Intake on Day 1 and Day 28||Day 1 and 28|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results.|||hours||95% Confidence Interval|Median
2678341|NCT01424228|Secondary|Change From Baseline in Percent SBM With Sensation of Complete Evacuation at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||percentage of SBM||Standard Deviation|Mean
2678342|NCT01424228|Secondary|Change From Baseline in Percent SCBM With No Straining and Severe/Very Severe Straining at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||percentage of SCBM||Standard Deviation|Mean
2678343|NCT01424228|Secondary|Change From Baseline in Straining Per SCBM at Up to 24 Weeks|Straining was evaluated on a 5-point scale (0=none, 1=mild, 2=moderate, 3=severe, or 4=very severe)|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||units on a scale||Standard Deviation|Mean
2678344|NCT01424228|Secondary|Change From Baseline in Percent SCBM With a Consistency of Normal and Hard/Very Hard at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||percentage of SCBM||Standard Deviation|Mean
2678345|NCT01424228|Secondary|Change From Baseline in Average Consistency Per SCBM at Up to 24 Weeks|Consistency measured using the 7-point Bristol scale where 1-2 indicate constipation (=hard/very hard), 3-4 are ideal stools (=normal), and 5-7 tending toward diarrhea.|Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||units on a scale||Standard Deviation|Mean
2678346|NCT01424228|Secondary|Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by 4-Week Treatment Period||Over 24 week treatment period|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results.|||percentage of subjects|||Number
2678347|NCT01424228|Secondary|Percent of Subjects With an Average Weekly Frequency of at Least 3 SCBM by Week||Over 24 week treatment period|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results.|||percentage of subjects|||Number
2678348|NCT01424228|Secondary|Change From Baseline in Spontaneous Complete Bowel Movements Per Week at Up to 24 Weeks||Baseline and Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||SCBM/week||Standard Deviation|Mean
2678349|NCT01424228|Secondary|Average Number of Spontaneous Complete Bowel Movements (SCBM) Per Week Up to 24 Weeks||Over 24 week treatment period|ITT population. Not all subjects in the ITT population had data for this outcome.|||SCBM/week||Standard Deviation|Mean
2678540|NCT01421667|Secondary|Time to Maximum Concentration (Tmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)|Time of maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All patients who were treated with brentuximab vedotin monotherapy and had Tmax of MMAE results.|||days||Full Range|Median
2678350|NCT01424228|Secondary|Percentage of Subjects With an Increase of ≥1 Spontaneous Complete Bowel Movement (SCBM) Per Week Up to 24 Weeks||Over 24 week treatment period|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. The 21 subjects with a risk of potential unblinding due to an error in the randomization system were excluded from the ITT Population to avoid the risk of bias to the study results.|||percentage of subjects|||Number
2678351|NCT01424228|Primary|The Percentage of Subjects With an Average of ≥3 Spontaneous Complete Bowel Movements (SCBM) Per Week Over the 24 Week Treatment Period|Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.|Over 24 week treatment period|Intent-to-Treat Population (ITT) includes all subjects randomized into the study who took at least 1 dose of investigational product. There were 21 subjects with a risk of potential unblinding due to an error in the randomization system who were excluded from the ITT Population to avoid the risk of bias to the study results.|||percentage of subjects|||Number
2678352|NCT01424189|Secondary|Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5|"Visual disturbances/distortions were reported by the participant on the Assessment of Photic Phenomena and Lens EffectS (APPLES) questionnaire, a Patient Reported Outcome (PRO) questionnaire intended to evaluate 10 distinct visual phenomena associated with cataract extraction and IOL implantation. The first 20 questions addressed both the frequency and severity of the phenomena using a 4-point categorical scale ranging from never to always (frequency) or none to severe (severity). The final (21st) question indicated whether the participant answered the questions based on experiences with or without glasses. The participant completed the assessment as a retrospective analysis of the previous week. Rate is presented as the percentage of participants with severity score severe for the visual phenomenon."|Month 12 from second eye implantation|This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).|||percentage of participants|||Number
2678353|NCT01424189|Primary|Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5|The rate of actual and potential secondary surgical interventions (SSIs) related to the optical properties of the IOL was estimated. If an ocular surgical intervention was performed, it qualified as an actual SSI; however; if the participant met the protocol-specified criteria that would warrant an SSI, but didn't actually undergo the SSI, it qualified as a potential SSI. Rate is presented as percentage of participants.|Month 12 from second eye implantation|This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye). For participants with actual SSIs, performance testing outcomes conducted prior to the secondary intervention were carried forward to the final analysis.|||percentage of participants|||Number
2678354|NCT01424189|Primary|Mean Monocular Uncorrected Near Visual Acuity (UCNVA) at Fixed Distance at Visit 5|VA was measured monocularly without visual correction using a hand-held ETDRS chart at a fixed distance that differed by lens model implanted. The logMAR ETDRS near visual acuity chart was designed for use at 40 cm; results obtained at other distances were converted to reflect the change in apparent letter size that results from the change in distance. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.|Month 12 from second eye implantation|This analysis population includes all participants with successful IOL implantation in the first implanted eye with data at visit.|||logMAR||Standard Deviation|Mean
2678355|NCT01424189|Primary|Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5|Visual acuity (VA) was measured monocularly (each eye separately) without visual correction using a 100% contrast ETDRS (Early Treatment of Diabetic Retinopathy Study) chart positioned 4 meters (m) from the participant under well-lit conditions. +0.25 diopter (D) spherical power was applied to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.|Month 12 from second eye implantation|This analysis population includes all participants with successful IOL implantation in the first implanted eye with data at visit.|||logMAR|eyes|Standard Error|Least Squares Mean
2678356|NCT01424072|Primary|Coping Strategy: Social Support Domain|"Scale information: Folkman and Lazarus Coping Strategy Inventory with 66 items. The scale is constructed by 8 different domains: confrontation, distancing, self-control, social support, acceptance of responsibility, escape avoidance, problem solving and positive reappraisal.The questions are scored by Likert scale: 0 (not used this strategy); 1 (used somewhat); 2 (used enough) and 3(used in large quantities) to the 66 items (Folkman and Lazarus Coping Strategy Inventory). It performed a summation of items and defined the scores: 0-4 points (not use this strategy), 5-9 (use this strategy a bit), 10-14 ( use this strategy quite) 14-18 (use strategy plenty)."|after 60 days|Of the 109 subjects, four were eliminated for having a low level of stress and three for not belonging to nursing staff;seven didn’t appear in the first session. Some lost sessions and were also excluded. One abandoned the treatment because of the side effects, one didn’t complete the questionnaire, seven went on vacation or sick leave(2).|||units on a scale||Standard Deviation|Mean
2678357|NCT01424072|Primary|Coping Strategy: Distancing Domain|The questions are scored by Likert scale: 0 (not used this strategy); 1 (used somewhat); 2 (used enough) and 3(used in large quantities) to the 66 items (Folkman and Lazarus Coping Strategy Inventory). It performed a summation of items and defined the scores: 0-4 points (not use this strategy), 5-9 (use this strategy a bit), 10-14 ( use this strategy quite) 14-18 (use strategy plenty).|after 75 days||||units on a scale||Standard Deviation|Mean
2678382|NCT01423760|Secondary|Overall Survival (OS)|Overall survival time was defined as the time from randomization to death. Subjects without events were censored at the last date they were known to be alive.|From randomization to death, assessed up to 3.6 years|Efficacy analysis was not performed due to the premature termination of this safety follow-up study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115)||||||
2679102|NCT01414413|Secondary|Loss to Retention|Comparison between study arms of the proportion of participants who initiate ART during the first 6-months of the HIV-testing intervention who are lost to retention within 6 months after initiating ART 6-months|The first 6-months following availability of home-based HIV testing||||participants|||Number
2678358|NCT01424072|Primary|Coping Strategy: Domain Social Support(After 60 Days)|"Scale information: Folkman and Lazarus Coping Strategy Inventory with 66 items. The scale is constructed by 8 different domains: confrontation, distancing, self-control, social support, acceptance of responsibility, escape avoidance, problem solving and positive reappraisal.The questions are scored by Likert scale: 0 (not used this strategy); 1 (used somewhat); 2 (used enough) and 3(used in large quantities) to the 66 items (Folkman and Lazarus Coping Strategy Inventory). It performed a summation of items and defined the scores: 0-4 points (not use this strategy), 5-9 (use this strategy a bit), 10-14 ( use this strategy quite) 14-18 (use strategy plenty)."|after 60days|Of the 109 subjects, four were eliminated for having a low level of stress and three for not belonging to nursing staff;seven didn’t appear in the first session. Some lost sessions and were also excluded. One abandoned the treatment because of the side effects, one didn’t complete the questionnaire, seven went on vacation or sick leave(2).|||units on a scale||Standard Deviation|Mean
2678359|NCT01424072|Secondary|Stress Scale|Scale information: Stress Symptoms List (LSS)with 60 items (better outcome)Low score: 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): >120 points.|after 60 days|Of the 109 subjects, four were eliminated for having a low level of stress and three for not belonging to nursing staff;seven didn’t appear in the first session. Some lost sessions and were also excluded. One abandoned the treatment because of the side effects, one didn’t complete the questionnaire, seven went on vacation or sick leave(2).|||units on a scale||Standard Deviation|Mean
2678360|NCT01424033|Primary|Pulmonary Function Tests|Not recorded. Study terminated due to departure of PI.|Every 3 months|||||||
2678361|NCT01423916|Secondary|Number of Participants With Maximum Change From Baseline to the On-treatment ECG Values on Day 11 for Heart Rate (HR), PR Interval, and QRS Interval.|Changes in HR with values 25% decrease from Day −1 and HR < 50 bpm and 25% increase from Day −1 and HR > 100 bpm; PR interval of greater than or equal to 25% change from Day −1 and PR > 200 msec; QRS interval of Greater than or equal to 25% change from Day −1 and > 100 msec were noted on Day 11. Maximum change from baseline to the on-treatment ECG values on Day 11 for heart rate.|Day 11|Electrocardiograms were sampled at predose and approximately 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose on Days -1, 1, 11, and 12.|||participants|||Number
2678362|NCT01423916|Secondary|Number of Participants With New Incidence of ECG Morphology Abnormalities on Day 11.|Participants with incidence of ECG morphology abnormalities on Day 11 (participants who had abnormalities during Day 11 but not at Day -1) were noted. Types of abnormalities included appearance of abnormal U waves, negative T waves, elevation of ST segment, depression of ST segment, second degree heart block, third degree heart block, right bundle branch block, and left bundle branch block. ECGs were sampled at predose and approximately 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose on Days -1, 1, 11, and 12.|Day 11|Number of participants who took at least one dose of study drug post Day −1, and had evaluations of the ECG parameters at Baseline and Post Baseline.|||participants|||Number
2678363|NCT01423916|Secondary|Number Participants Noted With New Incidence of QT Interval of > 500 Msec on Day 11.|The number of participants who were noted with new incidence of QT interval of > 500 msec on Day 11 and a 12-lead ECG was used.|Day 11|Assay sensitivity sample dataset demonstrated the ability of the trial that detected the effect of moxifloxacin on the QTcI that consisted from randomized participants in moxifloxacin and placebo arms, who had evaluable time-matched ECG assessments in both periods (Day -1/1 or Day 11/12) in placebo and moxifloxacin on Days -1, 1, 11, and 12.|||participants|||Number
2678364|NCT01423916|Secondary|Number of Participants With QTcI Interval > 60 Msec on Day 11.|The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). Participants with QTcI interval change of > 60 msec on Day 11 were presented here.|Day 11|Assay sensitivity dataset demonstrated the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed included those who had observations in QTc at both Days −1 and 11.|||participants|||Number
2678365|NCT01423916|Secondary|Number of Participants With QTcI Interval Between 30 and 60 Msec on Day 11.|The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). Participants with QTcI interval change between 30 to 60 msec were presented here.|Day 11|Assay sensitivity dataset shows the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed were total number of participants with both Baseline and at least one observation of the given parameter.|||participants|||Number
2678366|NCT01423916|Secondary|Change From Baseline in Summary of Maximum QTcI on Day 11 Minus Maximum QTcI on Day -1 (Baseline).|The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). The change from Baseline in summary of maximum QTcI on Day 11 minus maximum QTcI on Day -1 (Baseline) is presented here.|Baseline, Day 11|Assay sensitivity dataset demonstrated the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed included those who had observations in QTc at both Days −1 and 11.|||msec||Standard Deviation|Mean
2678367|NCT01423916|Secondary|Change From Baseline in Summary of Maximum QTcI on Day 11 Minus Mean QTcI on Day -1 (Baseline).|The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). The change form Baseline in summary of maximun QTcI on Day 11 minus mean QTcI on Day -1 (Baseline) is presented here.|Baseline, Day 11|Assay sensitivity dataset shows the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed were total number of participants with both Baseline and at least one observation of the given parameter.|||msec||Standard Deviation|Mean
2678368|NCT01423916|Secondary|Number of Participants Noted With Time-matched Change in Mean QTcI Change From Baseline for Assay Sensitivity of Moxifloxacin Treatment Corrected for Placebo at Day 11.|New onset (> 450, > 480, or > 500 msec) in QTc was defined as a participant who attained a QTc > 450, > 480, > 500 msec during Day 11 but not on Day −1. The number of participants were noted with time-matched change in mean QTcI change from Baseline for assay sensitivity of moxifloxacin treatment corrected for placebo. The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k).|Baseline, Day 11|Assay sensitivity dataset demonstrated the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed included those who had observations in QTc at both Days −1 and 11.|||participants|||Number
2678369|NCT01423916|Primary|Area Under the Plasma Concentration-time Curve During Dosing (AUCT).|Pharmacokinetics endpoint is the area under the concentration-time curve from time zero to 24 hours (AUC0-24h) of brexpiprazole and moxifloxacin. Area under the plasma concentration-time curve during the dosing interval at steady-state (AUCT) value was estimated using the linear trapezoidal rule; the value reported represent the area under the curves to the last time point during that day. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.|Day 11|PK analysis dataset consisted of all evaluable PK parameters from randomized participants who had plasma concentrations. For Moxifloxacin group, area under the plasma concentration-time curve was calculated to the last observable concentration.|||ng*h/mL||Standard Deviation|Mean
2678370|NCT01423916|Primary|Time to Maximum (Peak) Plasma Concentration (Tmax) of Brexpiprazole and Moxifloxacin.|Pharmacokinetics endpoint is the time to maximum (peak) plasma concentration (tmax) of brexpiprazole and moxifloxacin. Values for tmax were determined directly from the observed data. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.|Day 11|PK analysis dataset consisted of all evaluable PK parameters from randomized participants who had plasma concentrations.|||Hours||Full Range|Median
2678371|NCT01423916|Primary|Maximum Peak Plasma Concentration (Cmax) of Brexpiprazole and Moxifloxacin.|Pharmacokinetics endpoint is the maximum (peak) plasma concentration (Cmax) of brexpiprazole and moxifloxacin. Values for Cmax were determined directly from the observed data. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.|Day 11|Pharmacokinetics (PK) analysis dataset consisted of all evaluable PK parameters from randomized participants who had plasma concentrations.|||ng/mL||Standard Deviation|Mean
2678372|NCT01423916|Primary|Number of Participants With Adverse Events (AE) and Clinically Important Changes in Vital Signs, Physical Examinations, Laboratory Tests, and Standard ECGs (Electrocardiogram).|Clinically important changes in vital signs, physical examinations, laboratory tests and ECGs were by and large reflected in AE/SAE (which are presented in safety section) of this report.|AEs were recorded from Screening (informed consent was signed) during the 12-day treatment period to follow-up 30 (+ 2) days post-last dose of study medication|Safety dataset of randomized participants received 1 dose of study medication after Day 1.|||participants|||Number
2678373|NCT01423916|Primary|Time-matched QTcI Change From Baseline (Day −1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment.|Pharmacodynamics endpoint is the time-matched corrected QT interval (QTcI) change from baseline (Day -1) corrected for placebo on Day 11 following brexpiprazole treatment. The primary QT to QTc correction formula (QTcI) was determined for each participant using the participant's baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k was derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k).|Day 11 (Hours 1, 2, 3, 4, 5, 6, 8, 12, 16, 24)|The dataset quantitates effect of brexpiprazole on individual QTcI corrected for placebo of the completer population where participants received study medication from Day 1 to Day 11 (placebo at Day 1) had 1 Predose and Post-dose time-matched ECG assessments on Day 1 and Day 11. The first 5 time points for moxifloxacin arm only were 2-sided 98% CI.|||msec||90% Confidence Interval|Mean
2678374|NCT01423812|Secondary|Secondary Efficacy Endpoints|•Proportion of subjects with plasma HIV-1 RNA <50 c/mL at Week 24|week 24||||Participants|||Count of Participants
2678375|NCT01423812|Secondary|Medication Adherence Assessment|Characterize adherence to once-daily versus twice-daily darunavir/ritonavir containing regimens using the Modified Medication Adherence Self-Report Inventory (M-MASRI) scale|Within 48 weeks of randomization to study medications|||||||
2678376|NCT01423812|Secondary|Assessment of Virologic Failure|•Assess the development of viral resistance in subjects experiencing virological failure|Within 48 weeks of randomization to study medications|||||||
2678377|NCT01423812|Secondary|Immunologic Endpoints|•Absolute values and changes from baseline in CD4+ and CD8+ over time|48 weeks after randomization to study medications|||||||
2678378|NCT01423812|Secondary|Safety Assessment|•Compare the tolerability, safety, and change in lipid parameters(total cholesterol, LDL, HDL, triglycerides) of once-daily versus twice-daily darunavir/ritonavir containing regimens over 48 weeks|Within 48 weeks of randomization to study medications|||||||
2678379|NCT01423812|Secondary|Secondary Efficacy Endpoints|"Proportion of subjects with plasma HIV-1 RNA <50 c/mL and <400 c/mL at Week 24~Proportion of subjects with plasma HIV-1 RNA <400 c/mL at Week 48"|Within 48 weeks after randomization to study medication|||||||
2678380|NCT01423812|Primary|Primary Efficacy Endpoint for Virologic Suppression in HIV-infected Subjects|"Proportion of subjects with plasma HIV-1 RNA <50 c/mL at Week 48 using a Missing, Switch, or Discontinuation = Failure (MSDF) algorithm as codified by the FDA's snapshot algorithm"|48 weeks after randomization to study medication||||participants|||Number
2678381|NCT01423773|Primary|Final Comfort|"Comfort was assessed by the participant on a Visual Analog Scale of 0 to 100, where 0=Extremely Uncomfortable (My eyes are in pain. I cannot tolerate my lenses) and 100=Extremely Comfortable (My eyes feel GREAT, better than normal. I cannot feel my lenses)."|Day 2, Hour 10|All enrolled participants|||Units on a scale||Standard Deviation|Mean
2679103|NCT01414413|Secondary|Reporting of HIV-positive Results|Comparison of the proportion of all cluster adults confiding HIV-positive results to the resident community counsellor between study arms during the 1-year study period|The first 6-months following availability of home-based HIV testing||||participants|||Number
2678383|NCT01423760|Primary|Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death|An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect, AEs leading to discontinuation and AEs leading to death.|Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years|Only subjects treated with tecemotide were included in the safety analysis set.|||Subjects|||Number
2678384|NCT01423617|Secondary|Global Evaluation of Efficacy by Subjects|"The subjects evaluate independently the efficacy of the investigational product, using a scale with scores of very good, good, moderate and poor."|12 weeks|||||||
2678385|NCT01423617|Secondary|Global Evaluation of Safety by Subjects|"The subjects evaluate independently the safety of the investigational product, using a scale with scores of very good, good, moderate and poor."|12 weeks|||||||
2678386|NCT01423617|Secondary|Global Evaluation of Safety by Investigators|"The investigators evaluate independently the safety of the investigational product, using a scale with scores of very good, good, moderate and poor."|12 weeks|||||||
2678387|NCT01423617|Secondary|Changes in Body Fat Free Mass (kg)||12 weeks|||||||
2678388|NCT01423617|Secondary|Subjects' Global Feeling of Satiety|"Subject's feeling of satiety (subsequent to the three main meals) is judged globally by the subjects on the basis of a 4 point rating scale: 0 = no; 1 = slightly, 2 = moderate and 3 = strong."|12 weeks|||||||
2678389|NCT01423617|Secondary|Changes in Hunger, Eating, and Food-craving Related Items From the Control of Eating Questionnaire (COEQ)||12 weeks|||||||
2678390|NCT01423617|Secondary|Changes in Body Fat Content (%)||12 weeks|||||||
2678391|NCT01423617|Secondary|Changes in Waist-hip-ratio||12 weeks|||||||
2678392|NCT01423617|Secondary|Changes in Hip Circumference||12 weeks||||cm||Standard Deviation|Mean
2678393|NCT01423617|Secondary|Changes in Waist Circumference (cm)||12 weeks||||cm||Standard Deviation|Mean
2678394|NCT01423617|Secondary|Number of Subjects Who Lost at Least 3% of Baseline Body Weight||12 weeks||||participants|||Number
2678395|NCT01423617|Primary|Change in Mean Body Fat (kg)|Change in mean body fat at week 12 compared to baseline|12 weeks||||kg||Standard Deviation|Mean
2678396|NCT01423617|Primary|Change in Mean Body Weight (kg)|Change in mean body weight at week 12 compared to baseline.|12 weeks||||kg||Standard Deviation|Mean
2678397|NCT01423604|Secondary|Summary of Clinical Benefit|"A subject was considered a clinical benefit responder if he/she met at least 1 of the following criteria:~Subject showed improvement in at least one of the following parameters on successive scheduled observations without worsening in the others: pain intensity, analgesic use, or performance status~Subject was stable or improved on the pain intensity, analgesic use, and performance status and had a ≥ 7% increase in body weight maintained for 2 consecutive reporting periods that was not because of fluid accumulation."|Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.|||percentage of participants|||Number
2678398|NCT01423604|Secondary|Durable Response Rate|Durable response was defined as subjects with a response of Partial response (PR) or better at 2 subsequent measurements that were at least 4 weeks apart.|Measured every 4 weeks until death or PD, whichever was earlier (up to 8 months)|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.|||percentage of participants|||Number
2678399|NCT01423604|Secondary|Objective Response Rate|Objective response rate (ORR) was defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) measured by the investigator per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria during the treatment period. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Measured every 4 weeks for duration of study treatment (up to 8 months)|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.|||percentage of participants|||Number
2678400|NCT01423604|Secondary|Progression-Free Survival (PFS)|Progression-free survival was defined as the length of time between the date of randomization and the earlier of death or progressive disease (PD), whichever was earlier, as assessed by RECIST. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Analysis includes study data from the start of the study (first dose for that subject) until death or PD, whichever was earlier up to 8 months.|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.|||days||95% Confidence Interval|Median
2678401|NCT01423604|Primary|Overall Survival|Overall survival was measured as the length of time (in days) between the randomization date and the date of death.|Primary analysis includes study data from the start of the study (first dose for that subject) until the death of the subject (up to 8 months).|The intent-to-treat (ITT) population included subjects randomized in Part 2 of the study.|||days||95% Confidence Interval|Median
2678402|NCT01423253|Secondary|Change From Baseline to Week 12 (LOCF) in the SDS Total Score|The Sheehan Disability Scale (SDS) is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).|Baseline to week 12|Safety Population - 12 subjects did not have the SDS total score at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
2678538|NCT01421719|Secondary|Number of Incontinence Episodes Per Day|Urinary incontinence 6 months after treatment (n=16). Data are included for participants who completed all diary entries and attended the Month 6 visit|6 months|Per protocol. Quantified from 3-day voiding diary at baseline and each clinical evaluation to 6 months. Mean change in daily incontinence made up analysis.|||leaks/day||Standard Deviation|Mean
2678403|NCT01423253|Secondary|Change From Baseline to Week 12 (LOCF) in the HAM-A Total Score|The Hamilton Rating Scale for Anxiety (HAM-A) is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.|Baseline to week 12|Safety Population - 4 subjects did not have the HAM-A assessment at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
2678404|NCT01423253|Secondary|Change From Baseline to Week 12 (LOCF) in the YMRS Total Score|The Young Mania Rating Scale (YMRS) is an 11-item instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.|Baseline to week 12|Safety population - 2 subject did not have YMRS assessment at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
2678405|NCT01423253|Secondary|Change From Baseline to Week 12 (LOCF) in CGI-S Score|The Clinical Global Impression - Severity of illness (CGI-S) score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.|baseline to week 12|Safety population - 1 subject did not have the CGI-S assessment at week 12 (LOCF)|||units on a scale||Standard Deviation|Mean
2678406|NCT01423253|Primary|Percentage of Subjects Who Discontinued Due to Treatment Emergent Adverse Events (TEAEs)|Percentage of subjects who discontinued due to Treatment Emergent Adverse Events (TEAEs)|12 Weeks|Safety Population|||percentage of subjects|||Number
2678407|NCT01423253|Primary|Percentage of Subjects With Treatment Emergent Serious Adverse Events (TESAEs)|Percentage of subjects with Treatment Emergent Serious Adverse Events (TESAEs)|12 Weeks|Safety Population|||percentage of subjects|||Number
2678408|NCT01423253|Secondary|Mean Change From Baseline to Week 12 (LOCF) in MADRS Total Scores|"Mean change from baseline to week 12 (LOCF) in Montgomery-Asberg Depression Rating Scale (MADRS) total scores The MADRS is a clinician-rated assessment of the subject's level of depression and consists of 10 items. Each item is rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the ten items and ranges from 0 to 60. Higher scores are associated with greater severity."|Baseline to12 Weeks|Safety population - only 47 subjects had the MADRS assessment at Week 12 (LOCF).|||units on a scale||Standard Deviation|Mean
2678409|NCT01423253|Primary|Percentage of Subjects With Treatment Emergent Adverse Events (TEAEs)|Percentage of subjects with treatment emergent adverse events (TEAEs)|12 Weeks|Safety population|||percentage of subjects|||Number
2678410|NCT01423162|Primary|Percent Iron Absorption|Percentage of iron available for absorption from fortified oat drink with and without added vitamin C|14 days after administration|Per protocol|||percentage of Iron absorbed||Standard Error|Mean
2678411|NCT01423084|Secondary|Number of Subjects Reporting SAEs and AE Leading to Withdrawal|Number of subjects reporting any Serious AEs (SAEs), medically attended AEs and AEs that result in a subject's withdrawal from the study after any vaccination.|Throughout the study period.|Safety Set|||Number of subjects|||Number
2678412|NCT01423084|Secondary|Number of Subjects Reporting Unsolicited AEs|Number of subjects reporting any Unsolicited AEs after any vaccination.|From day 1 to day 7 after any vaccination.|Safety Set|||Number of subjects|||Number
2678413|NCT01423084|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)|Number of subjects reporting solicited local and systemic Adverse Events and other indicators of reactogenicity after any vaccination.|From day 1 to day 7 after any vaccination|Safety Set|||Number of subjects|||Number
2678414|NCT01423084|Secondary|GMR of ELISA GMCs Against Antigen 287-953 at Day 45.|The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 45 vs baseline).|Two weeks after the second vaccination (day 45)|Per Protocol Set, immunogenicity subset|||Ratio of GMTs||95% Confidence Interval|Geometric Mean
2678415|NCT01423084|Primary|ELISA Geometric Mean Concentration (GMCs) Against Vaccine Antigen 287-953|The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.|One month after the second vaccination (day 61)|Per Protocol Set population|||IU/ml||95% Confidence Interval|Geometric Mean
2678416|NCT01423084|Secondary|ELISA GMCs Against Vaccine Antigen 287-953 at Day 45.|The immune response of two different lots of rMenB+OMV NZ is evaluated in terms of ELISA GMCs against vaccine antigen 287-953.|Two weeks after the second vaccination (day 45)|Per Protocol Set, immunogenicity subset.|||IU/ml||95% Confidence Interval|Geometric Mean
2678417|NCT01423084|Secondary|Percentage of Subjects With hSBA ≥1:5 Against Each of N. Meningitidis Serogroup B Reference Strains at Day 45.|The immune response of two different lots of rMenB+OMV NZ against each of N. Meningitidis serogroup B reference strains is evaluated in terms of percentages of subjects with hSBA ≥1:5 two weeks after the last vaccination.|Two weeks after the second vaccination (day 45)|Per Protocol Population, immunogenicity subset|||Percentage of subjects||95% Confidence Interval|Number
2678418|NCT01423084|Secondary|GMRs of GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.|"The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of GMRs of GMT against 3 N.~meningitidis serogroup B reference strains at two weeks after last vaccination."|Two weeks after the second vaccination (day 45)|Per Protocol Set, Immunogenicity subset|||Ratio of GMTs||95% Confidence Interval|Geometric Mean
2678419|NCT01423084|Secondary|hSBA GMT Against 3 N. Meningitidis Serogroup B Reference Strains at Day 45.|The immunogenicity of two different lots of rMenB+OMV NZ is evaluated in terms of hSBA GMT against 3 N. Meningitidis serogroup B reference strains at two weeks after last vaccination.|Two weeks after the second vaccination (day 45)|Per Protocol Set, immunogenicity subset|||Titers||95% Confidence Interval|Geometric Mean
2678420|NCT01423084|Secondary|Geometric Mean Ratio (GMR) of ELISA Geometric Mean Concentration (GMCs) Against Antigen 287-953|The immune response of two different lots of rMenB+OMV NZ against antigen 287-953 is evaluated in terms of GMRs between ELISA GMCs (day 61 vs baseline).|One month after the second vaccination (day 61)|Per Protocol Set Population|||Ratio of GMTs||95% Confidence Interval|Geometric Mean
2679115|NCT01414244|Secondary|Stool Frequency|Baseline and 8 week at the conclusion of therapy|Baseline and 8 weeks following therapy||||stools per day||Standard Deviation|Mean
2678421|NCT01423084|Secondary|Geometric Mean Ratio (GMR) of GMTs Against Each of N. Meningitidis Serogroup B Reference Strains.|The immune response of two different lots of rMenB+OMV NZ against each of N. meningitidis serogroup B test strains is evaluated in terms of GMR between GMTs (1month after the second vaccination vs baseline).|One month after the second vaccination (day 61)|Per Protocol Set Population|||Ratio of GMTs||95% Confidence Interval|Geometric Mean
2678422|NCT01423084|Secondary|Percentage of Subjects in Each Lot With hSBA ≥ 1:5|The percentage of subjects in each lot with hSBA ≥ 1:5 at one month after the second vaccination for each of the three reference strains (H44/76, 5/99, and NZ98/254) for each vaccine group|One month after the second vaccination (day 61)|Per Protocol Set population|||Percentage of subjects||95% Confidence Interval|Number
2678423|NCT01423084|Primary|Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against 3 Neisseria.Meningitidis (N. Meningitidis) Serogroup B Reference Strains.|Consistency of the immune response of the two lots of rMenB+OMV NZ will be assessed at one month after the second vaccination based on the ratio of the vaccine lot hSBA GMTs for each of three serogroup B reference strains (H44/76, 5/99, and NZ98/254) and based on the ratio of Enzyme-linked Immunosorbent Assay (ELISA) GMCs for vaccine antigen 287-953. The equivalence interval will be (0.5, 2.0).|One month after the second vaccination (day 61)|Per Protocol Set population|||Titers||95% Confidence Interval|Geometric Mean
2678424|NCT01422915|Primary|Protoporphyrin Concentration in Blood|"erythrocyte protoporphyrin concentration, ug/dl~plasma protoporphyrin concentration, ug/dl"|Samples collected while on treatment (range 93-208 treatment days)||||ug/dl||Standard Deviation|Mean
2678425|NCT01422915|Primary|Photosensitivity, Assessed by Measuring the Number of Minutes of Sun Tolerance|Minutes of sun tolerance|At 60 days of treatment|All of the original 4 subjects had bona fide erythropoietic protoporphyria (EPP). One subject was removed during Perdiod 1. The data from the same 3 subjects who completed periods 1 and 2 were analyzed for the study results. Data collected was not tractable for statistical analysis given the range of results|||minutes||Standard Deviation|Mean
2678426|NCT01422889|Secondary|Stent Thrombosis|Academic Research Consortium (ARC) defined (definite/probable) stent thrombosis (ST) in the ION registry population. For the protocol specified secondary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.|Annually, after the first year, through 2 years.|There were 57 subjects not evaluable for 2-year cardiac events (No follow-up ≥ 700 days and events-free within 730-day) leaving a total of 1054 subjects evaluated for ARC ST Definite/Probable.|||percentage of participants|||Number
2678427|NCT01422889|Primary|Cardiac Death or Myocardial Infarction (CD/MI)|Cardiac Death or myocardial infarction (CD/MI) in the ION registry population. For the protocol specified primary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.|12 Months|There were 83 subjects not evaluable for 12-month cardiac events (No follow-up ≥ 335 days and events-free within 365-day) leaving a total of 1028 subjects evaluated for 12 month CD/MI.|||percentage of paricipants|||Number
2678428|NCT01422876|Secondary|Occurrence of Treat to Target Efficacy Response for Treatment Naive Patients|Occurrence of the treat-to-target efficacy response for Treatment Naive patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.|24 Weeks|Full Analysis Set (FAS) with non-completers considered failures (NCF). FAS-treatment naive patients randomised and treated who had a baseline (HbA1c>= 7% at baseline are included) and at least 1 on treatment HbA1c value with NCF approach, in which missing data due to premature discontinuation of a patient were considered as failure.|||% of patients satisfying HbA1c <7.0%||95% Confidence Interval|Number
2678429|NCT01422876|Secondary|Occurrence of Treat to Target Efficacy Response for Metformin Background Patients|Occurrence of the treat-to-target efficacy response for Metformin Background patients measured as HbA1c < 7.0% after 24 weeks of treatment for patients with HbA1c >=7.0% at baseline.|24 Weeks|Full Analysis Set (FAS) with non-completers considered failures (NCF). FAS- Metformin background patients randomised and treated who had a baseline (HbA1c>= 7% at baseline are included) and at least 1 on treatment HbA1c value with NCF approach, in which missing data due to premature discontinuation of a patient were considered as failure.|||% of patients satisfying HbA1c <7.0%||95% Confidence Interval|Number
2678430|NCT01422876|Secondary|Change From Baseline in Body Weight for Treatment Naive Patients|Change from baseline in body weight for Treatment Naive patients.|Baseline and 24 Weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all treatment naive patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.|||kg change from baseline||Standard Error|Least Squares Mean
2678431|NCT01422876|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Treatment Naive Patients|Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.|Baseline and 24 weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all treatment naive patients randomised to and treated who had a baseline and at least 1 on treatment HbA1c value.|||% change from baseline||Standard Error|Least Squares Mean
2678432|NCT01422876|Secondary|Change From Baseline in Body Weight for Metformin Background Patients|Change from baseline in body weight for Metformin Background patients.|Baseline and 24 Weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all Metformin Background patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.|||kg change from baseline||Standard Error|Least Squares Mean
2678433|NCT01422876|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 24 for Treatment Naive Patients|Change from baseline in fasting plasma glucose at week 24 for Treatment Naive patients.|Baseline and 24 Weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all treatment naive patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.|||mg/dL change from baseline||Standard Error|Least Squares Mean
2678434|NCT01422876|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 24 for Metformin Background Patients|Change from baseline in fasting plasma glucose at week 24 for Metformin Background patients.|Baseline and 24 Weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all Metformin Background patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.|||mg/dL change from baseline||Standard Error|Least Squares Mean
2678435|NCT01422876|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) for Metformin Background Patients|Glycosylated hemoglobin (HbA1c) is a measurement of the percentage of hemoglobin that is glycated. The change from baseline in HbA1c is calculated as the week 24 HbA1c minus the baseline HbA1c. Since HbA1c is measured as a percentage the change from baseline is also a percentage.|Baseline and 24 weeks|Full Analysis Set (FAS) with last observation carried forward (LOCF). FAS - all Metformin Background patients randomised and treated who had a baseline and at least 1 on treatment HbA1c value.|||% change from baseline||Standard Error|Least Squares Mean
2678436|NCT01422850|Primary|Blood Pressure, Pulse and Temperature|Blood pressure, pulse and temperature were monitored frequently during 48 hours post injection of the study product, and thereafter at each follow up visit.|At planned study visit´s at study week 0, 4, 5, 6, 7, 9, 10, 11, 12, 14, 15, 16, 18, 21, 24 and at study visit week 25||||participants|||Number
2678437|NCT01422850|Secondary|The Secondary Endpoint for This Study is to Establish if Any Indications of a Positive Therapeutic Effect on the Prostate Cancer May be Observed.|No significant conclusion of efficacy is possible due to the study design with only one group of patients. However by analyzing and comparing the outcome with the data the individual patient presented at baseline some trends of efficacy, defined as stable disease or partial response, are possible. Trends towards possible treatment response were measured by monitoring PSA, a potential marker for prostate cancer disease progression; by other blood markers; and by Quality of life questionnaire (EORTC QLQ-C30) and WHO/ECOG (Eastern Cooperative Oncology Group). Control of any bone metastases were followed by hotspots and bone scan index measured by skeletal scintigraphy.|Within 12 weeks||||participants|||Number
2678438|NCT01422850|Primary|Adverse Events|"To show safety and tolerability patients was monitored closely after administration of ALECSAT and during the follow up period. Heart rate, temperature, blood pressure, Performance status was monitored. Blood samples analysed were: PSA, Alkaline Phosphatase (ALP), Lactate DeHydogenase (LDH), Creatinine (CREAT) and Standard haematology: Blood picture (complete blood count, haemogram), leucocytes, Differential count, electrolytes, renal function, and liver count (liver enzymes).~AE and SAE was reported during the study period and the Investigator was urged to judge whether the event was related to the study product or not."|At planned study visit´s at study week 0, 4, 5, 6, 7, 9, 10, 11, 12, 14, 15, 16, 18, 21, 24 and at study visit week 25|No formal statistical analysis plan was considered for this study. Any subject that received one administration of ALECSAT and a 6 week follow-up period will be considered as having received ALECSAT and be included in the efficacy part of the report. All patients that received at least one injection of ALECSAT was assessed for safety.|||Events|||Number
2678439|NCT01422824|Secondary|Hemoglobin Levels||Baseline; Weeks 8, 16, 24, 48|Efficacy intent-to-treat population included all treated participants. Here, 'n' signifies the number of participants with available data for hemoglobin at specified visits.|||gram per liter||Standard Deviation|Mean
2678440|NCT01422824|Primary|Number of Participants With Adverse Events (AEs)|AE: any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE (SAE): resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, or was medically significant. Any AE included participants with both serious and non-serious AEs.|Up to 12 months|Safety population|||participants|||Number
2678441|NCT01422720|Secondary|Change From Baseline in Standardized Seizure Frequency|Absolute and relative changes from baseline of seizure frequency standardised to a frequency per 4 weeks.|8-week Baseline Period and 26-week Treatment Period||||seizures/4 weeks||Standard Deviation|Mean
2678442|NCT01422720|Primary|Number of Subjects With Reported Adverse Events (AE)|"An AE was defined as Treatment-Emergent Adverse Event (TEAE), if first onset or worsening was after the first intake of investigational medicinal product (IMP) and not more than 14 days after the last administration of IMP.~TEAE assessment:~patients who died~patients who died due to Treatment-emergent adverse event (TEAE)~patients with at least one Serious Adverse Event (SAE)~patients with at least one Treatment-emergent Serious Adverse Event (TESAE)~patients prematurely terminated due to TEAE~patients with at least one TEAE~patients with at least one related TEAE~patients with at least one severe TEAE~patients without any TEAE"|throughout the study||||participants|||Number
2678443|NCT01422538|Secondary|Subject Satisfaction at 180 Days Post-treatment|Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 180 days post-treatment Responses were tabulated.|180 days post-treatment|Data analyzed includes PSQ responses at 180 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied.|||percentage of participants Satisfied|||Number
2678444|NCT01422538|Secondary|Subject Satisfaction at 90 Days Post-treatment|Subjects rated their satisfaction as Very Satisfied, Satisfied, Dissatisfied or Very Dissatisfied using a Patient Satisfaction Questionnaire (PSQ). Responses at 90 days post-treatment Responses were tabulated.|90 days post-treatment.|Data analyzed includes PSQ responses at 90 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied or Satisfied.|||percentage of participants Satisfied|||Number
2678445|NCT01422538|Other Pre-specified|Subject's Assessment of Pain|Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 1 representing no pain and 10 representing the worst pain possible. Pain assessment data were obtained from Group A and Group C subjects only.|During Ulthera study treatment||||units on a scale||Full Range|Mean
2678446|NCT01422538|Secondary|Overall Aesthetic Improvement at 180 Days Post-treatment|"At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse Any Improvement includes subjects assessed in categories 1-3."|180 days post-treatment||||percentage of participants improved|||Number
2719652|NCT01102374|Secondary|Severity of Acute Respiratory Infections|ARIs resulting in emergency department visits or hospitalizations|12 month||||events|||Number
2678447|NCT01422538|Secondary|Overall Aesthetic Improvement at 90 Days Post-treatment|"At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS) (Physician GAIS - PGAIS; Subject GAIS - SGAIS), comparing to pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse Any Improvement includes subjects assessed in categories 1-3."|90 days post-treatment.||||percentage of participants improved|||Number
2678448|NCT01422538|Primary|Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs.|Three masked assessors reviewed pre- and 90 days post-treatment photos from 29 subjects who returned for their 90-day follow-up visit, assessing for improvement in skin laxity at 90 days post-treatment compared to baseline, i.e., lifted and tightened skin in the areas treated with the assigned study treatment based on the assigned study arm.|90 days post-treatment||||percentage of participants improved|||Number
2678449|NCT01422434|Secondary|Change in mPASI From Baseline to Week 1|The extent of and severity of redness, thickness and scaliness of psoriasis were recorded for each of three regions (arms, trunk and legs) and these were used to calculate mPASI. The m-PASI could range from 0 to 64.8. The least severe outcome is 0 and the most severe outcome is 64.8|Baseline to Week 1||||percentage of change||Standard Deviation|Mean
2678450|NCT01422434|Secondary|Physician's Global Assessment of Psoriasis|"Subjects with 'clear' or 'almost clear' disease by physician's global assessment on the following 6 point scale: clear, almost clear, mild, moderate, severe, very severe.~The assessment represents the average lesion severity on the trunk and limbs. The assessment was based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit."|Week 4||||participants|||Number
2678451|NCT01422434|Secondary|Change From Baseline in Target Lesion Assessment|"Percentage change in composite severity score of the target lesion from baseline to Week 4.~At Visit 1, the investigator selected a target lesion. Location was recorded as trunk, limb excluding elbow and/or knee.~At Visits 1-4, the investigator assessed the severity of the target lesion for each sign (redness, thickness and scaliness) on a scale from 0 to 8 where 0 is no signs of redness, thickness or scaliness and 8 is the most severe signs of redness, thickeness or scaliniess.~The individual scores for redness, thickness and scaliness were added together to give a single composite score for severity of the target lesion which could range from 0 to 24. The percentage change in the composite severity score from baseline to each visit was also calcutated."|Baseline to Week 4||||percentage of change||Standard Deviation|Mean
2678452|NCT01422434|Primary|Change From Baseline in Modified Psoriasis Area and Severity Index (mPASI)|"The primary response criterion was the percentage change in m-PASI from baseline to Week 4.~The extent of and severity of redness, thickness and scaliness of psoriasis were recorded for each of three regions (arms, trunk and legs) and these were used to calculate mPASI using the following formula:~Arms: 0.2(R+T+S)E = X Trunk: 0.2(R+T+S)E = Y Legs: 0.2(R+T+S)E = Z where R = score for redness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) T = score for thickness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) S = score for scaliness (using a scale from 0 to 4, where o is non signs and 4 is the most severe signs) E = score for extent (using a scale from 0 to 6, where 0 is no involvement and 6 is 90-100% involvemnet) The sum of X + Y + Z gave the total m-PASI, which could range from 0 to 64.8."|Baseline to Week 4||||percentage of change||Standard Deviation|Mean
2678453|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Tube Weight Based Compliance Characteristics|"Association of response in symptoms with tube weight based compliance (Itching)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.~Groups are made by % of tube used by weight."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678454|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Tube Weight Based Compliance Characteristics|"Association of response in symptoms with tube weight based compliance (Dyspareunia)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.~Groups are made by % of tube used by weight."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678473|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Age Characteristics|"Association of response in symptoms with characteristics of the subject population (Dryness and Age)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678455|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Tube Weight Based Compliance Characteristics|"Association of response in symptoms with tube weight based compliance (Dryness)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with compliance determined by % of tube used by weight.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.~Groups are made by % of tube used by weight."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678456|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Patient Reported Compliance Characteristics|"Association of response in symptoms with patient reported compliance (Itching)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.~Groups are made by % of compliance reported by patients"|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678457|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Patient Reported Compliance Characteristics|"Association of response in symptoms with patient reported compliance (Dyspareunia)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.~Groups are made by % of compliance reported by patients"|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678458|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Patient Reported Compliance Characteristics|"Association of response in symptoms with patient reported compliance (Dryness)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with patient reported compliance.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.~Groups are made by % of compliance reported by patients"|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678459|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Indication for Endocrine Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Itching and Indications)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678460|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Indication for Endocrine Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Dyspareunia and Indications)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678539|NCT01421667|Secondary|Baseline Soluble CD30 Expression|Serum concentration of soluble CD30 before first dose of brentuximab vedotin|Baseline|All patients who were treated with brentuximab vedotin monotherapy and had baseline sCD30 expression results.|||ng/mL||Full Range|Median
2678461|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Indication for Endocrine Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Dryness and Indications)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678462|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Prior Cytotoxic Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Itching and prior cytotoxic therapy)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678463|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Prior Cytotoxic Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Dyspareunia and prior cytotoxic therapy)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678464|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Prior Cytotoxic Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Dryness and prior cytotoxic therapy)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678465|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Current Endocrine Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Itching and current endocrine therapy)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678466|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Current Endocrine Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Dyspareunia and current endocrine therapy)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2679145|NCT01414166|Secondary|Percent Change From Baseline in HDL-C at Week 16|The percentage change from baseline in the participants' HDL-C was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.||||||
2678467|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics|"Association of response in symptoms with characteristics of the subject population (Dryness and current endocrine therapy)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678468|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics|"Association of response in symptoms with characteristics of the subject population (Itching and Menopause status)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678469|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Menopause Status Characteristics|"Association of response in symptoms with characteristics of the subject population (Dyspareunia and Menopause status)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678470|NCT01422408|Secondary|Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics|"Association of response in symptoms with characteristics of the subject population (Dryness and Menopause status)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678471|NCT01422408|Secondary|Change in Vaginal Itching Symptom Scores by Age Characteristics|"Association of response in symptoms with characteristics of the subject population (Itching and Age)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678472|NCT01422408|Secondary|Change in Dyspareunia Symptom Scores by Age Characteristics|"Association of response in symptoms with characteristics of the subject population (Dyspareunia and Age)~Determine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population.~Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks|The rows are sub-groups of the total number analyzed. The sum of the row counts matches the overall number.|||units on a scale||Inter-Quartile Range|Median
2678474|NCT01422408|Secondary|Number of Patients Experiencing Toxicities|Toxicity data will be reported as descriptive data as the percentage of patients experiencing reported side effects. Toxicity and safety analyses will be conducted using the safety analysis set.|Over 4 weeks|Toxicity and safety analyses will be conducted using the safety analysis set.|||Participants|||Count of Participants
2678475|NCT01422408|Secondary|Change in Total Vaginal Index Score.|"Change in total vaginal index score. The total vaginal index score is a numerical value ranging from zero to twelve, comprised of the three components of vaginal dryness, vaginal itching, and dyspareunia graded on an ordinal scale of zero to four added together.~Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -12 to +12; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms.~Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints."|Baseline and 4 weeks||||units on a scale||Inter-Quartile Range|Median
2678476|NCT01422408|Secondary|Change in Symptom Scores of Vaginal Itching|"Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-secondary endpoints.~Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks||||units on a scale||Inter-Quartile Range|Median
2678477|NCT01422408|Primary|Change in Symptom Scores of Dyspareunia|"Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.~Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks||||units on a scale||Inter-Quartile Range|Median
2678478|NCT01422408|Primary|Change in Symptom Scores of Vaginal Dryness|"Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively). Analyzed using Wilcoxon signed rank test with 2.5% significance level to account for two co-primary endpoints.~Outcome measures median change in score from baseline to end of study. Scale is explained above for the scoring of symptoms at each time point. The median change (i.e. median difference) can range from -4 to +4; negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms."|Baseline and 4 weeks||||units on a scale||Inter-Quartile Range|Median
2678479|NCT01422382|Secondary|Number of Participants With at Least One Adverse Event.||24 Days||||Participants|||Number
2678480|NCT01422382|Primary|NK-104 AUC||15 Days|All subjects with measurable pharmacokinetic (PK) values|||ng * h/mL||Standard Deviation|Mean
2678481|NCT01422369|Secondary|Number of Participants With at Least One Adverse Event.||16 Days|All subjects who took at least one dose of study medication.|||Participants|||Number
2678482|NCT01422369|Primary|NK-104 AUC||16 Days|All subjects with measurable pharmacokinetic (PK) values.|||ng * h/mL||Standard Deviation|Mean
2678483|NCT01422356|Primary|HPV Prevalence|Prevalence of anal HPV of any type at baseline|Baseline|Number of men at baseline visit|||participants|||Number
2678484|NCT01422304|Other Pre-specified|Number of Participants With One or More Postoperative Anemia Adverse Events With Onset Within 72 Hours After Study Drug Administration|This measure is the incidence of postoperative anaemia with an onset within 72 hours after study drug administration. A participant is included in the count for this measure if an adverse event with any of the following event terms occurred in the participant with onset within the defined time frame: postoperative anaemia, anaemia, haemorrhagic anaemia, haemoglobin decreased or haemoglobin S decreased.|Up to 72 hours post study drug administration|APaT population|||participants|||Number
2678485|NCT01422304|Other Pre-specified|Postoperative Changes in Hgb Concentrations Using the Bleeding Index|The Bleeding Index was used to describe postoperative changes in Hgb concentrations at Visit 3. Bleeding Index = Hgb level at Visit 3 - Hgb level at baseline, adjusted for the amount of RBCs transfused. Missing baseline Hgb values were imputed using the overall mean Hgb value at baseline.|Baseline and Visit 3 (24-48 hours post study drug administration)|APaT population|||g/L||Standard Deviation|Mean
2678486|NCT01422304|Other Pre-specified|Total Transfusion Volume in Participants Who Required Postoperative Transfusion|"Among participants who received a transfusion unit (e.g., whole blood, packed RBCs, cell saver RBCs, fresh frozen plasma, platelets) that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous [i.e., predose] transfusion for participants who had received a previous transfusion), the total volume of blood transfused post study drug was calculated. The volume of blood transfused post study drug (using linear interpolation when transfusions were ongoing at the time of study drug administration) was converted to grams of Hgb transfused, using RBC concentration information received from the investigators. The sum of Hgb transfused was standardized to normal volume Hgb in homologous whole blood, using 20 g/dL Hgb for calculation of the standardized volume."|From end of study drug administration through approximately 120 hours after study drug administration|Participants in APaT population who received a transfusion unit that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous [i.e., predose] transfusion for participants who had received a previous transfusion)|||mL||Geometric Coefficient of Variation|Geometric Mean
2678507|NCT01422213|Secondary|Change From Baseline to Week 8 in CGI-S Score|The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.|Baseline and Week 8|FAS|||units on a scale||Standard Error|Mean
2678487|NCT01422304|Other Pre-specified|Number of Participants Requiring Any Postoperative Transfusion|The number of participants who received a transfusion unit (e.g., whole blood, packed RBCs, cell saver RBCs, fresh frozen plasma, platelets) that started after study drug administration and within 120 hours after study drug administration (or within 48 hours after any previous [i.e., predose] transfusion for participants who had received a previous transfusion) was determined.|From end of study drug administration through approximately 120 hours after study drug administration|APaT population|||participants|||Number
2678488|NCT01422304|Other Pre-specified|Postoperative Drainage Volume Within 24 Hours After Study Drug Administration|The total volume of postoperative drainage from the surgical site over the 24 hours after study drug administration was recorded.|Up to 24 hours post study drug administration|APaT population|||mL||Standard Deviation|Mean
2678489|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Events of Anaphylaxis With Onset Within 14 Days After Study Drug Administration|This Measure is identified in study protocol as an Other Secondary Outcome Measure. Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. Adverse events suggestive of hypersensitivity which met defined criteria (e.g., serious event) and/or suspected events of anaphylaxis were evaluated by a blinded external Adjudication Committee to determine whether such events met either of the following two criteria for anaphylaxis (Sampson et al. J Allergy Clin Immunol 2006;117:391-7) - 1. Acute onset of an illness with involvement of the skin, mucosal tissue or both, and at least one of the following: a) respiratory compromise, b) reduced blood pressure (BP) or associated symptoms of end-organ dysfunction. 2. Two or more of the following that occur rapidly after exposure to a likely allergen for that participant: a) involvement of the skin-mucosal tissue, b) respiratory compromise, c) reduced BP or associated symptoms, d) persistent gastrointestinal symptoms.|Up to 14 days post study drug administration|APaT population|||participants|||Number
2678490|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Venous Thromboembolic (VTE) Events With Onset Within 14 Days After Study Drug Administration|This Measure is identified in study protocol as an Other Secondary Outcome Measure. Suspected symptomatic VTE events were evaluated by a blinded external Adjudication Committee. The confirmation of a VTE event was based on determination of a clinically meaningful venous thrombosis (e.g., pulmonary embolism or deep vein thrombosis).|Up to 14 days post study drug administration|APaT population|||participants|||Number
2678491|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 14 Days After Study Drug Administration|This Measure is identified in study protocol as an Other Secondary Outcome Measure. All SUAEB were evaluated by a blinded external Adjudication Committee. MBE = one or more of the following: 1) Fatal bleeding; 2) Bleeding that is symptomatic and occurs in critical area/organ, in a non-operated joint, or is intramuscular with compartment syndrome; 3) Extrasurgical site bleeding causing a fall in Hgb level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or RBCs, occurring within 24 hours of the bleeding; 4) Surgical site bleeding requiring second intervention, or bleeding at operated joint that interferes with rehabilitation; or 5) Surgical site bleeding that is unexpected/prolonged and/or causes hemodynamic instability, with fall in Hgb level of at least 20 g/L (1.24 mmol/L) or transfusion of at least two units of whole blood or RBCs, occurring within 24 hours of the bleeding.|Up to 14 days post study drug administration|APaT population|||participants|||Number
2678492|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Major Events of Bleeding With Onset Within 24 Hours After Study Drug Administration|This Measure is identified in study protocol as an Other Secondary Outcome Measure. All SUAEB were evaluated by a blinded external Adjudication Committee. Major bleeding event (MBE) = one or more of the following: 1) Fatal bleeding; 2) Bleeding that is symptomatic and occurs in critical area/organ, in a non-operated joint, or is intramuscular with compartment syndrome; 3) Extrasurgical site bleeding causing a fall in hemoglobin (Hgb) level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red blood cells (RBCs), occurring within 24 hours of the bleeding; 4) Surgical site bleeding requiring second intervention, or bleeding at operated joint that interferes with rehabilitation; or 5) Surgical site bleeding that is unexpected/prolonged and/or causes hemodynamic instability, with fall in Hgb level of at least 20 g/L (1.24 mmol/L) or transfusion of at least two units of whole blood or RBCs, occurring within 24 hours of the bleeding.|Up to 24 hours post study drug administration|APaT population|||participants|||Number
2678493|NCT01422304|Secondary|Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 14 Days After Study Drug Administration|"This Measure is identified in study protocol as an Other Secondary Outcome Measure. Post-treatment events of bleeding were evaluated by a medically-qualified, blinded member of the surgical team (Blinded Safety Assessor), in consultation with the surgeon, to determine if an event was a suspected, unanticipated adverse event of bleeding (SUAEB). A SUAEB is an event of bleeding outside the usual boundaries of expectations for a participant considering the type of procedure as well as participant's specific surgical experience and underlying risk of bleeding. In addition, blinded review of clinical and laboratory databases was performed to identify any event potentially consistent with a SUAEB; these were reviewed by the Blinded Safety Assessor, who determined if any was a SUAEB. All SUAEBs were evaluated by a blinded external Adjudication Committee, which classified each as either: 1) a major bleeding event, 2) a non-major bleeding event, or 3) not an unanticipated event of bleeding."|Up to 14 days post study drug administration|APaT population|||participants|||Number
2678494|NCT01422304|Secondary|Percent Change From Baseline in Prothrombin Time (International Normalized Ratio) (PT[INR]) at 10 and 60 Minutes Post Study Drug Administration|Change from baseline in PT(INR) is identified in study protocol as an Other Secondary Outcome Measure. Blood samples for determination of PT(INR) values were obtained at baseline and at 10 and 60 minutes after study drug administration. PT(INR) is a performance indicator measuring the efficacy of the extrinsic and common blood coagulation (blood clotting) pathways. The INR is the ratio of a participant's prothrombin time to a normal (control) sample, raised to the power of the International Sensitivity Index (ISI) value for the analytical system used (INR = [PT-Test/PT-Normal]^ISI). Higher values of PT(INR) indicate a reduction in the clotting tendency of blood.|Baseline, 10 and 60 minutes post study drug administration|Participants in APaT population who had baseline and at least one post baseline PT(INR) measurement within defined assessment window (10 or 60 minutes post study drug).|||percent change||Standard Deviation|Mean
2719653|NCT01102374|Primary|Number of Acute Respiratory Infections (ARIs)|ARIs defined as upper or lower respiratory infections|12 months||||events|||Number
2678495|NCT01422304|Secondary|Percent Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at 10 and 60 Minutes Post Study Drug Administration|Change from baseline in aPTT is identified in study protocol as the Key Secondary Outcome Measure. Blood samples for determination of aPTT values were obtained at baseline and at 10 and 60 minutes after study drug administration. aPTT is a performance indicator measuring the efficacy of the intrinsic and common blood coagulation (blood clotting) pathways. Higher values of aPTT indicate a reduction in the clotting tendency of blood.|Baseline, 10 and 60 minutes post study drug administration|Participants in APaT population who had baseline and at least one post baseline aPTT measurement within defined assessment window (10 or 60 minutes post study drug).|||percent change||Standard Deviation|Mean
2678496|NCT01422304|Primary|Number of Participants With One or More Adjudicated Events of Bleeding (Major or Non-major) With Onset Within 24 Hours After Study Drug Administration|"Post-treatment events of bleeding were evaluated by a medically-qualified, blinded member of the surgical team (Blinded Safety Assessor), in consultation with the surgeon, to determine if an event was a suspected, unanticipated adverse event of bleeding (SUAEB). A SUAEB is an event of bleeding outside the usual boundaries of expectations for a participant (e.g., in amount of blood lost, prolonged duration of bleeding, or other factors) considering the type of procedure as well as participant's specific surgical experience and underlying risk of bleeding. In addition, blinded review of clinical and laboratory databases was performed to identify any event potentially consistent with a SUAEB; these were reviewed by the Blinded Safety Assessor, who determined if any was a SUAEB. All SUAEBs were evaluated by a blinded external Adjudication Committee, which classified each as either: 1) a major bleeding event, 2) a non-major bleeding event, or 3) not an unanticipated event of bleeding."|Up to 24 hours post study drug administration|APaT population|||participants|||Number
2678497|NCT01422239|Secondary|Change in Smoking From Baseline to the Followup Assessment (Week 12)|Change in number of cigarettes per day (CPD) (averaged over the previous week) from the baseline assessment (Week 0) to the followup assessment (Week 12) for participants who did not quit smoking during the study.|Week 0 (baseline), Week 12 (one month followup)|Participants who completed the week 8 appointment and provided the number of cigarettes smoked per day were included.|||CPD||Standard Deviation|Mean
2678498|NCT01422239|Secondary|Point-prevalence Smoking Abstinence Four Weeks After the End of the Trial Assessed by Self-report and Carbon Monoxide Levels|point-prevalence smoking abstinence assessed at one month after the completion of counseling and measured by self-report (no smoking reported in the previous 7 days) and confirmed by carbon monoxide levels (CO levels < 5ppm)|12 weeks|participants who did not complete the appointment were considered to be smoking|||participants|||Number
2678499|NCT01422239|Primary|Point-prevalence Smoking Abstinence Assessed at the End of the Trial and Measured by Self-report and Confirmed by Carbon Monoxide Levels|point-prevalence smoking abstinence assessed at the end of the trial and measured by self-report (no smoking reported in the previous 7 days) and confirmed by carbon monoxide levels (CO levels < 5ppm)|Up to 8 weeks|Participants who dropped out of the study were considered to be smoking.|||participants|||Number
2678500|NCT01422226|Primary|Ease of IUD Insertion (Use of Ancillary Measures)|The primary outcome is the proportion in each group able to have the IUD inserted in a standard fashion without the ancillary measures of mechanical dilation of the cervix, placement of paracervical nerve block, or using abdominal ultrasound for guidance. The null hypothesis for the primary outcome is that misoprostol does not influence difficulty of insertion.|During the IUD insertion procedure, up to 2 hours||||participants|||Number
2678501|NCT01422213|Secondary|Risk of Suicidality Using C-SSRS Scores|"The Columbia-Suicide Severity Rating Scale (C-SSRS) was developed by researchers at Columbia University as a tool to systematically assess suicidal ideation and behaviour in patients during participation in a clinical study. The C-SSRS is composed of questions that address suicidal behaviour and questions that address suicidal ideation, with subquestions that assess severity. The tool was administered via an interview with the patient.~For 2 patients in each treament group (6 in total) the CSSRS assessments are missing during study."|Up to 8 weeks|APTS|||participants|||Number
2678502|NCT01422213|Secondary|Change From Baseline to Week 8 Using the MADRS Total Score and the Composite Z-score|"Effect on cognitive dysfunction after correcting for the effect on depressive symptoms.~The estimation of the effect on cognitive dysfunction after correcting for the effect on depressive symptoms was based on the composite z-score and the MADRS total score. The effect was estimated in an ANCOVA model using the composite z-score at week 1 as dependent variable and the change from baseline to week 1 in the MADRS total score, the baseline MADRS total score, the baseline composite z-score, the treatment group and site as independent variables."|Baseline and Week 8|FAS, LOCF|||z score||Standard Error|Least Squares Mean
2678503|NCT01422213|Secondary|Change From Baseline to Week 1 Using the MADRS Total Score and the Composite Z-score|"Effect on cognitive dysfunction after correcting for the effect on depressive symptoms.~The estimation of the effect on cognitive dysfunction after correcting for the effect on depressive symptoms was based on the composite z-score and the MADRS total score. The effect was estimated in an ANCOVA model using the composite z-score at week 1 as dependent variable and the change from baseline to week 1 in the MADRS total score, the baseline MADRS total score, the baseline composite z-score, the treatment group and site as independent variables.~In the week 1 analysis the vortioxetine 10 and 20 mg groups were pooled because patients randomized to vortioxetine 20 mg received vortioxetine 10 mg in the first week of the study."|Baseline and Week 1|FAS, LOCF|||z score||Standard Error|Least Squares Mean
2678504|NCT01422213|Secondary|Proportion of Remitters at Week 8 (Remission is Defined as a MADRS Total Score <=10)||Week 8|FAS, LOCF|||percentage of participants|||Number
2678505|NCT01422213|Secondary|Proportion of Responders at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline||Baseline and Week 8|FAS, last observation carried forward (LOCF)|||percentage of participants|||Number
2678506|NCT01422213|Secondary|Clinical Status Using CGI-I Score at Week 8|The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse). The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.|Week 8|FAS|||units on a scale||Standard Error|Mean
2679146|NCT01414166|Secondary|Percent Change From Baseline in the Ratio of LDL-C to High-Desity Lipoprotein Cholesterol (HDL-C) at Week 16|The percentage from baseline in the participants' ration of LDL-C to HDL-C was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed||||||
2678508|NCT01422213|Secondary|Change From Baseline to Week 8 in MADRS Total Score|The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.|Baseline and Week 8|FAS|||units on a scale||Standard Error|Mean
2678509|NCT01422213|Secondary|Change From Baseline to Week 8 in the CRT (Attention)||Baseline and Week 8|FAS|||log10 (ms)||Standard Error|Mean
2678510|NCT01422213|Secondary|Change From Baseline to Week 8 in the SRT (Speed of Processing)|"Simple Reaction Time (SRT) is designed to assess psychomotor speed, and Choice Reaction Time (CRT) is designed to assess visual attention. Two computerised tests, part of the CogState battery were used to measure SRT and CRT in milliseconds:~The detection task measures SRT: the patient presses a yes button, whenever an onscreen playing card is turned over.~The identification task measures CRT: the patient presses a yes button whenever an onscreen playing card is turned over and is red, or a no button if the card is not red."|Baseline and Week 8|FAS|||log10 (ms)||Standard Error|Mean
2678511|NCT01422213|Secondary|Change From Baseline to Week 8 in Incongruent STROOP Time to Complete (Executive Function)||Baseline and Week 8|FAS|||seconds||Standard Error|Mean
2678512|NCT01422213|Secondary|Change From Baseline to Week 8 in Congruent STROOP Time to Complete (Executive Function)|Stroop Colour Naming Test (STROOP) is a cognitive test designed to assess the ability to inhibit a prepotent response to reading words while performing a task that requires attention control. It comprises two sheets with 50 words on each, and each word is the name of a colour. On the first sheet, the Congruent STROOP Sheet, the word and ink colour match; on the Incongruent STROOP Sheet, the word and ink colour do not match. For each sheet, the patient has 4 minutes to name the ink colour of each word. When the patient finishes the sheet, or once 4 minutes is up, the clinician notes the time taken and counts the number of correct and incorrect responses. The scale ranges from 0-100, the higher score the greater the cognitive flexibility.|Baseline and Week 8|FAS|||seconds||Standard Error|Mean
2678513|NCT01422213|Secondary|Change From Baseline to Week 8 in the TMT B (Executive Function)|TMT is a cognitive test designed to assess scanning, visuomotor tracking, executive function, and cognitive flexibility. It consists of two parts, A and B: the patient must draw lines to connect consecutively numbered circles (part A) and then connect consecutively numbered and lettered circles alternating between the two sequences (part B). The time taken to complete the two parts is recorded. Part B examines executive functioning and ability to shift cognitive set. The lower the score the faster the ability to shift cognitive set.|Baseline and Week 8|FAS|||seconds||Standard Error|Mean
2678514|NCT01422213|Secondary|Change From Baseline to Week 8 in the TMT A (Speed of Processing)|Trail Making Test (TMT) is a cognitive test designed to assess scanning, visuomotor tracking, executive function, and cognitive flexibility. It consists of two parts, A and B: the patient must draw lines to connect consecutively numbered circles (part A) and then connect consecutively numbered and lettered circles alternating between the two sequences (part B). The time taken to complete the two parts is recorded. Part A assesses cognitive processing speed. The lower the score the faster the processing speed.|Baseline and Week 8|FAS|||seconds||Standard Error|Mean
2678515|NCT01422213|Secondary|Change From Baseline to Week 8 in RAVLT (Delayed Recall)|Rey Auditory Verbal Learning Task (RAVLT) is a cognitive test designed to assess verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded.|Baseline and Week 8|FAS|||number of words correctly recalled||Standard Error|Mean
2678516|NCT01422213|Secondary|Change From Baseline to Week 8 in RAVLT (Acquisition)|Rey Auditory Verbal Learning Task (RAVLT) is a cognitive test designed to assess verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded.|Baseline and Week 8|FAS|||number of words correctly recalled||Standard Error|Mean
2678517|NCT01422213|Secondary|Change From Baseline to Week 8 in DSST (Number of Correct Symbols)|"Digit Symbol Substitution Test (DSST) is a cognitive test designed to assess psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-second period. Each correct symbol is counted, and the total score ranges from 0 (less than normal functioning) to 133 (greater than normal functioning). as a description of DSST."|Baseline and Week 8|FAS|||number of correct symbols||Standard Error|Mean
2678518|NCT01422213|Primary|Change From Baseline to Week 8 in DSST (Number of Correct Symbols) and RAVLT (Acquisition and Delayed Recall) Using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scores|"DSST assesses psychomotor speed of performance requiring visual perception, spatial decision-making, and motor skills. It consists of 133 digits and requires the patient to substitute each digit with a simple symbol in a 90-s period. Each correct symbol is counted, and the total score ranges from 0 (< normal functioning) to 133 (> normal functioning).~RAVLT assesses verbal learning and memory, including immediate memory, efficiency of learning, retroactive and proactive interference effects, and encoding versus retrieval. It consists of a number of tasks, including immediate recall and delayed recall. The number of words correctly recalled on each task is recorded.~The scores are standardized by subtracting the overall mean change from baseline from the individual change from baseline and dividing by the standard deviation estimate of the change from baseline. The 2 tests, DSST and RAVLT are each assigned a weight of 0.5, the 2 subtests of RAVLT are each assigned a weight of 0.25."|Baseline and Week 8|FAS|||z score||Standard Error|Mean
2678519|NCT01422187|Secondary|Hemoglobin|Hemoglobin measure yearly|60 months||||mg/dL||Standard Error|Mean
2678520|NCT01422187|Secondary|Platelet Count|Platelet count measure annually|60 months||||platelets/mm^3||Standard Error|Mean
2678521|NCT01422187|Secondary|Liver Volume|Liver volume by MRI|60 months||||Milliliters||Standard Error|Mean
2678522|NCT01422187|Primary|Spleen Volume|Spleen volume measured by MRI|60 months||||Milliliters||Standard Error|Mean
2719654|NCT01102270|Secondary|Sleep Duration|total sleep duration|8 hour In-Laboratory Polysomnogram (PSG)||||hours of sleep||Standard Error|Mean
2678523|NCT01422161|Secondary|Disability Measured by Modified Rankin Scale Score Pre-Treatment|Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The mRS is an ordered scale coded from 0 (no symptoms at all), 1 (No significant disability despite symptoms; able to carry out all usual duties and activities), 2 (Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance), 3 (Moderate disability; requiring some help, but able to walk without assistance), 4 (Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance), 5 (severe disability) and 6 (death).|Pre-Treatment||||Modified Rankin Scale Score||Standard Deviation|Mean
2678524|NCT01422161|Secondary|Motor Impairment Measured by the Fugl-Meyer Scale Post-Treatment|Scale is comprised of five domains and there are 155 items in total: Motor functioning (in the upper and lower extremities); Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints); Balance (contains 7 tests, 3 seated and 4 standing); Joint range of motion (8 joints); Joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1= perform partially, 2 = perform fully).|1 Day and 90 Days|Total upper limb Fugl Meyer Score out of 66.|||score on a scale||Standard Error|Mean
2678525|NCT01422161|Secondary|Disability Measured by Modified Rankin Scale Score Post-Treatment|Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.The mRS is an ordered scale coded from 0 (no symptoms at all), 1 (No significant disability despite symptoms; able to carry out all usual duties and activities), 2 (Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance), 3 (Moderate disability; requiring some help, but able to walk without assistance), 4 (Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance), 5 (severe disability) and 6 (death).|90 Days||||Modified Rankin Scale Score||Standard Deviation|Mean
2678526|NCT01422161|Secondary|Measure of Upper Limb Motor Impairment Measured by Fugl Meyer Scale|"This scale has 3 points for each item. A zero is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. Reflex activity is measured using 2 points only, with a score of 0 or 3 for absence and presence of reflex. The maximum total score that can be obtained in Fugl Meyer assessment is 226, though it is common practice to assess all domains separately.The five domains assessed by Fugl-Meyer scale are:~Motor function (Maximum score in upper limb = 66; Maximum score in lower limb = 34) Sensory function (Maximum score = 24) Balance (Maximum score = 14) Range of motion of joints (Maximum score = 44) Joint pain (Maximum score = 44)"|Pre-Treatment, Day 90|Total upper limb Fugl Meyer scale score out of 66.|||Fugl Meyer Scale Score||Standard Error|Mean
2678527|NCT01422161|Primary|Time Taken to Form a Stable Grasp Post Treatment|"Hand motor impairment (execution and planning) during a functional grasp and lift tasks.~Hand function."|90 Days|Time taken to form a stable grasp.|||Preload phase duration in Seconds||Standard Error|Mean
2678528|NCT01422161|Primary|Time Taken to Form a Stable Grasp Pre-Treatment|"Assessments are done on day 1, before the 1st Botulinum toxin injection.~They will be assessed for:~Hand motor impairment (execution and planning) during a functional grasp and lift tasks.~Hand function."|Day 1|Improved motor execution as measured by the time taken to form a stable grasp.|||Preload phase duration in Seconds||Standard Error|Mean
2678529|NCT01422135|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for EE|Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.|6 weeks|Primary PK population|||ng*hr/mL||Standard Deviation|Mean
2678530|NCT01422135|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) (0-168) Profile for LNG|Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.|6 weeks|Primary PK population|||ng*hr/mL||Standard Deviation|Mean
2678531|NCT01422135|Primary|Steady-State Concentration (Css) (48-168) Profile for EE|Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.|6 weeks|Primary PK population|||pg/mL||Standard Deviation|Mean
2678532|NCT01422135|Primary|Steady-State Concentration (Css) (48-168) Profile for LNG|Pharmacokinetic (PK) sampling will be done after exposure to each anatomic location. PK evaluations were performed at the following time points: hour (immediately prior to dosing) and at 3 hours, 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.|6 weeks|Primary PK population|||pg/mL||Standard Deviation|Mean
2678533|NCT01422070|Secondary|Number of ICU Readmissions|Number of readmissions to intensive care unit during the same hospital course|Max 90 days after admission to the Study Unit||||readmissions|||Number
2678534|NCT01422070|Secondary|Length of Hospital Stay|Number of days (calendar days -1) from admission to the Study Unit to discharge from the hospital|Max 90 days after admission to the Study Unit||||days||Inter-Quartile Range|Median
2678535|NCT01422070|Secondary|Length of ICU Stay|Number of days (calendar days -1) from admission to and discharge from the Study Unit|Max 90 days after admission to intensive care unit||||days||Inter-Quartile Range|Median
2678536|NCT01422070|Primary|Vital Status at Hospital Discharge|Hospital mortality of the patients admitted to intensive care units with or without intermediate care unit in the hospital|Max 90 days after admission to the Study Unit||||participants|||Number
2678537|NCT01421719|Primary|Number of Patients Requiring Catheterization for Urinary Retention Secondary to Treatment.|Requirement for catheter because of urinary retention.|zero to six months||||participants|||Number
2679727|NCT01409382|Other Pre-specified|Pregnancy and Neonatal Outcomes|Early miscarriages, 2nd and 3rd trimester losses, preterm deliveries, take-home babies, neonatal hypoglycemia: number of babies|Three years||||participants (babies)|||Number
2678541|NCT01421667|Secondary|Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) (Cycle 1)|Maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All patients who were treated with brentuximab vedotin monotherapy and had Cmax of MMAE results.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2678542|NCT01421667|Secondary|Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) (Cycle 1)|Trough concentration of ADC from 0 to 21 days following the first dose of brentuximab vedotin|3 weeks|All patients who were treated with brentuximab vedotin monotherapy and had Ctrough of ADC results.|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2678543|NCT01421667|Secondary|Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) (Cycle 1)|End of infusion concentration of ADC following the first dose of brentuximab vedotin|1 day|All patients who were treated with brentuximab vedotin monotherapy and had Ceoi of ADC results.|||ug/mL||Geometric Coefficient of Variation|Geometric Mean
2678544|NCT01421667|Secondary|Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy|Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|Up to 3 years|All participants who received treatment with brentuximab vedotin monotherapy.|||participants|||Number
2678545|NCT01421667|Secondary|Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression|Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), or stable disease (SD, no new sites and no change in size of previous lesions) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. Patients are grouped by CD30-positivity or CD30u (undetectable CD30).|Up to 3 years|All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2678546|NCT01421667|Secondary|Progression-Free Survival With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis|Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment.|||months||Full Range|Median
2678547|NCT01421667|Secondary|Duration of Complete Remission With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis|Duration of complete remission (CR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin monotherapy and achieved CR|||months||Full Range|Median
2678548|NCT01421667|Secondary|Duration of Objective Response With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis|Duration of complete remission (CR) or partial remission (PR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin monotherapy and achieved a CR or PR.|||months||Full Range|Median
2678549|NCT01421667|Secondary|Complete Remission (CR) Rate by Investigator|Percentage of participants treated with brentuximab vedotin monotherapy or brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received brentuximab vedotin monotherapy or brentuximab vedotin plus rituximab and had both a baseline and at least one post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2678550|NCT01421667|Secondary|Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab|Percentage of participants treated with brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin plus rituximab and had both a baseline and at least one post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2678551|NCT01421667|Primary|Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab|Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.|Up to 3 years|All participants who received treatment with brentuximab vedotin plus rituximab.|||participants|||Number
2678552|NCT01421667|Primary|Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy|Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.|Up to approximately 3 years|All participants who received treatment with brentuximab vedotin monotherapy and had both a baseline and at least one post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2678553|NCT01421654|Primary|Hours Used|The number of hours that each group used the device will be compared between subjects using fixed pressure with the Acclimate mode and subjects using fixed pressure without the Acclimate mode.|30 days||||Total Hours Used||Standard Deviation|Mean
2719664|NCT01102257|Secondary|Change on Brief Ocular Discomfort Inventory (BODI)||90 +/- 14 days following initiation of drug regimen|||||||
2678554|NCT01421641|Secondary|Tenaculum Placement Satisfaction|Satisfaction with overall tenaculum placement procedure. Subjects asked to answer their overall satisfaction with the pain control. Subjects asked to complete 100mm Visual Analog Scale (0mm=not at all satisfied to 100mm=very satisfied)|After placement of the tenaculum||||mm||Standard Deviation|Mean
2678555|NCT01421641|Secondary|Intervention Pain|Pain with the intervention (injection or gel application). Subjects are asked to complete pain scale using a 100mm Visual Analog Scale (0mm=no pain and 100mm=worst pain of my life)|after application of randomized intervention||||mm||Standard Deviation|Mean
2678556|NCT01421641|Primary|Tenaculum Pain|The primary outcome was pain at the time of tenaculum placement. Patient asked to pain scale using 100mm Visual Analog Scale (0mm=no pain, 100mm=worst pain of my life) during after tenaculum placement.|After tenaculum placement|4 subjects were excluded due to protocol violations|||mm||Standard Deviation|Mean
2678557|NCT01421589|Secondary|Change in Phosphocreatine Recovery|Change in phosphocreatine recovery, represented by ViPCr, from Baseline to 12-weeks is reported.|Baseline and 12-weeks|Obese men with reduced GH secretion were treated with rhGH for 12 weeks. All 15 subjects underwent 31P-MRS, however, two scans were not evaluable due to technical difficulties.|||mM/min||Standard Error|Mean
2678558|NCT01421589|Secondary|Change in Insulin Sensitivity|Change in fasting glucose from Baseline to 12-weeks is reported.|Baseline and 12-weeks||||mg/dl||Standard Error|Mean
2678559|NCT01421589|Secondary|Change in Inflammatory Marker|Change in high sensitivity C-reactive protein (hsCRP) from Baseline to 12-weeks is reported.|Baseline and 12-weeks||||mg/l||Standard Error|Mean
2678560|NCT01421589|Secondary|Change in Body Composition|Change in waist circumference from Baseline to 12-weeks is reported.|Baseline and 12-weeks||||cm||Standard Error|Mean
2678561|NCT01421589|Secondary|Change in Skeletal Muscle IGF-1 Gene Expression|Change in skeletal muscle IGF-1 gene mRNA expression from Baseline to 12-weeks is reported.|Baseline and 12-weeks|Paired analyses (both Baseline and 12-weeks) from only 10 subjects are available for gene expression|||fold change||Standard Error|Mean
2678562|NCT01421589|Secondary|Change in Circulating IGF-1 Concentration|Change in circulating IGF-1 from Baseline to 12-weeks is reported.|Baseline and 12-weeks||||ug/l||Standard Error|Mean
2678563|NCT01421589|Primary|Phosphocreatine Recovery|The primary objective of this study is to determine the effects of growth hormone on mitochondrial function as assessed by 31P-MRS in obese subjects with reduced GH secretion. Mitochondrial function was represented by ViPCr, a measure of phosphocreatine recovery after sub-maximal exercise. Univariate regression analyses was performed to assess the relationship between the change in skeletal muscle IGF-1 mRNA after 12 weeks treatment with rhGH to change in ViPCr.|12-weeks|All 15 subjects underwent 31P-MRS, however, two scans were not evaluable due to technical difficulties. In addition, paired analyses (both Baseline and 12-weeks) from only 10 subjects were available for gene expression analyses. Therefore univariate regression analyses between IGF-1 mRNA and PCr recovery could only be performed in 10 subjects.|||correlation coefficient|||Number
2678564|NCT01421511|Secondary|Change From Baseline in Patient-reported Pain, by Study Visit|0=no pain, 10=worst pain Only 1 visit per participant for Day 4-6, only 1 visit for Day 7-9, and only 1 visit for Day 10-13.|Multiple|The Intent to Treat analysis set includes data from all randomized participants.|||units on a scale||Standard Deviation|Mean
2678565|NCT01421511|Secondary|Investigator's Assessment of Clinical Response at the Day-7 Visit|Clinical improvement defined as improvement in overall clinical status.|Day 7|The Intent to Treat analysis set includes data from all randomized participants.|||participants|||Number
2678566|NCT01421511|Secondary|Investigator's Assessment of Clinical Response at the 48-72 Hour Visit|Clinical improvement defined as improvement in overall clinical status.|48-72 Hours|The Intent to Treat analysis set includes data from all randomized participants.|||participants|||Number
2678567|NCT01421511|Secondary|Investigator's Assessment of Clinical Success of the Post Therapy Evaluation Visit in Clinically Evaluable-Post Treatment Evaluation Analysis Set.|Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, no new signs, symptoms or complications attributable to the ABSSSI and no further antibiotic therapy required for treatment of primary ABSSSI lesion.|Post-Treatment Evaluation (7-14 days after the End of Therapy)|All randomized participants receiving minimal study therapy, completed EOT and PTE Investigator's assessments, no concomitant systemic antibiotic therapy through PTE, and no confounding events or factors.|||participants|||Number
2678568|NCT01421511|Secondary|Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit|Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, and no further antibiotic therapy required for treatment of primary ABSSSI lesion.|Post-Treatment Evaluation (7-14 days after the End of Therapy)|The Intent to Treat analysis set includes data from all randomized participants.|||participants|||Number
2678569|NCT01421511|Secondary|Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set|Responder: No increase in lesion surface area from baseline.|End of Therapy Day 11|All randomized participants receiving minimal study therapy, completed EOT assessment, no concomitant systemic antibiotic therapy and no confounding events or factors.|||participants|||Number
2678570|NCT01421511|Secondary|Clinical Response at the End of Therapy Visit|Responder: No increase in lesion surface area from baseline.|Day 11|The Intent to Treat analysis set includes data from all randomized participants.|||participants|||Number
2678571|NCT01421511|Primary|The Early Clinical Response Rate|Responder: No increase in lesion surface area from baseline.|48-72 hours|The Intent to Treat analysis set includes data from all randomized participants.|||participants|||Number
2678581|NCT01421459|Secondary|Insulin Dose Per Body Weight (U/kg) Per Day|Insulin dose in units (U) per body weight in kilograms (kg) per day. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline Insulin Dose per Body Weight measure; last observation carried forward (LOCF).|||units per kilogram per day (U/kg/day)||Standard Error|Least Squares Mean
2679918|NCT01406860|Secondary|Length of Stay||Participants will be followed for the duration of their emergency department visit after the initiation of treatment (Average Length of stay in minutes)|Data were not collected||||||
2678572|NCT01421498|Primary|Ocular Symptom: Change From Baseline in Visual-Related Subscale of the Symptom Functional Scale Score to Day 84|The symptom functional scale is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers. The 12 items of the symptom functional scale questionnaire were graded on a scale of 0 (none of the time) to 4 (all of the time). The index consisted of 3 sub scales: symptoms (sensitivity to light, gritty sensation, pain, blurred vision, and poor vision [Items 1-5]), visual-related sub scale of the symptom functional scale (ability to read, drive at night, use a computer, watch television [Items 6-9]), and environmental triggers (windy conditions, low humidity, air conditioning [Items 10-12]). The symptom functional scale was scored on a scale of 0 to 100, with higher scores representing greater disability. Negative change from baseline indicates improvement.|Baseline (Day 0) to Day 84|ITT population with LOCF.|||units on a scale||Standard Deviation|Mean
2678573|NCT01421498|Primary|Ocular Sign: Change From Baseline in Inferior Corneal Fluorescein Staining to Day 84|Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. The staining was graded with the Ophthalmic Research Associates, Inc. (ORA) scale. The corneal surface is divided into three regions: superior, central and inferior. The scores for each of these 3 regions ranged from 0 to 4 (0=no staining/none; 1=occasional/trace; 2=countable/mild; 3=uncountable, but not confluent/moderate; 4=confluent/severe) with 0.5 point increments, and lower score indicates a better outcome. Inferior corneal fluorescein staining scores from the study eye only were reported. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.|Baseline (Day 0) to Day 84|Intent-to-Treat (ITT) population with Last Observation Carried Forward (LOCF) included all randomized participants who received at least 1 dose of investigational product.|||units on a scale||Standard Deviation|Mean
2678574|NCT01421472|Primary|Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR)|Pathologic Complete Response was defined as the absence of invasive cancer in the breast and lymph nodes following completion of neoadjuvant systemic therapy and reported according to the current AJCC staging system for neoadjuvant clinical studies. The endpoint was to determine the pathologic Complete Response (pCR) rates associated with weekly treatment of MM-121 plus paclitaxel followed by the combination treatment of doxorubicin plus cyclophosphamide compared with weekly paclitaxel alone followed by the combination treatment of doxorubicin plus cyclophosphamide in patients with human epidermal growth factor receptor 2 (HER2)-negative primary breast cancer.|At time of surgery, an expected average of 24-26 weeks|Subjects with evaluable resection.|||participants|||Number
2678575|NCT01421459|Other Pre-specified|Percentage of Participants With Treatment Emergent Antibody Response (TEAR)|TEAR is defined as an absolute increase of at least 1% in insulin antibody levels (measured in % binding) and at least 30% relative increase from Baseline for participants who are insulin antibody-positive at Baseline, or turning from insulin antibody-negative status at Baseline to antibody-positive during the course of the study following treatment with study drug.|4 weeks and 12 weeks and 24 weeks and Endpoint (up to 24 weeks) and Baseline to 24 weeks (Overall)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline analysis to detect insulin antibodies; last observation carried forward (LOCF).|||percentage of participants|||Number
2678576|NCT01421459|Other Pre-specified|Percentage of Participants With Detectable Insulin Antibody Levels||Baseline and 4 weeks and 12 weeks and 24 weeks and Endpoint (up to 24 weeks) and Baseline to 24 weeks (Overall)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline analysis to detect insulin antibodies; last observation carried forward (LOCF).|||percentage of participants|||Number
2678577|NCT01421459|Secondary|Rate Per 30 Days of Hypoglycemic Events|The rate of hypoglycemic events per 30 days between two visits is defined as the total number of events between the visits divided by the actual number of days between the visits, and then multiplied by 30 days. A hypoglycemic event is defined as any time a participant has a blood glucose (BG) level of ≤70 milligrams per deciliter (mg/dL) even if the event was not associated with signs, symptoms, or treatment consistent with current guidelines (American Diabetes Association 2005). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions. Severe Hypoglycemic events may or may not have a reported BG ≤70 mg/dL. These events may be associated with sufficient neuroglycopenia to induce seizure or coma.|Baseline, Endpoint (up to 24 weeks)|All randomized participants who received at 1 dose of study drug with Baseline at least 1 post-Baseline hypoglycemic event.|||hypoglycemic events per 30 days||Standard Deviation|Mean
2678578|NCT01421459|Secondary|Incidence of Hypoglycemic Events|A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose (BG) concentration of ≤70 milligrams/deciliter (mg/dL) even if it was not associated with signs, symptoms, or treatment consistent with current American Diabetes Association (ADA: 2005) guidelines. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.|Baseline and Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline hypoglycemic event measure.|||hypoglycemic events in 24 weeks|||Number
2678579|NCT01421459|Secondary|Percentage of Participants With HbA1c <7 % and HbA1c ≤6.5%|Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.|Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks and Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline HbA1c measure; last observation carried forward (LOCF).|||percentage of participants|||Number
2678580|NCT01421459|Secondary|Insulin Dose (Units)|Units of insulin taken daily. Least Square (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1C, country, sulfonylurea use, time of basal insulin injection and treatment.|Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline insulin dose measure; last observation carried forward (LOCF).|||units per day (U/day)||Standard Error|Least Squares Mean
2678582|NCT01421459|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ)|ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen [(IR) 5 items: domain scores range (DSR) 5-35], Lifestyle Flexibility [(LF) 3 items: DSR 3-21], Glycemic Control [(GC) 3 items: DSR 3-21], Hypoglycemic Control [(HC) 5 items: DSR 5-35], Insulin Delivery Device [(IDD) 6 items: DSR 6-42]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100*[(7-mean raw score)/6]. Higher scores indicate better treatment satisfaction. Least Squares (LS) mean are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|4 weeks (wk) and 12 wk and Endpoint (EP) (up to 24 wk)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline ITSQ measure; last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2678583|NCT01421459|Secondary|Adult Low Blood Sugar Survey (ALBSS)|"ALBSS contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (almost always). Items are categorized in 2 domains: Behavior (or avoidance) Items 1 to 15 and Worry (or affect) Items 16 to 33. Behavior Total Score range is 0 to 60 and Worry Total Score range is 0 to 72. Higher scores on Behavior items (related to avoidance of hypoglycemia) reflect greater awareness and/or effort of the participant to prevent low blood sugar. Higher scores on Worry items (related to worries about low blood sugar and its consequences) reflect greater participant concern about having low blood sugar. The ALBSS Total Scores (Worry and Behavior item scores combined) range is 0 to 132. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment."|4 weeks (wk) and 12 wk and Endpoint (up to 24 wk)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline ALBSS measure; last observation carried forward (LOCF).|||units on a scale||Standard Error|Least Squares Mean
2678584|NCT01421459|Secondary|Change From Baseline in Body Weight|Change from baseline in body weight. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|Baseline and 4 weeks (wk) and 8 wk and 12 wk and 16 wk and 20 wk and 24 wk and Endpoint (up to 24 wk)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline body weight measure; last observation carried forward (LOCF).|||kilogram (kg)||Standard Error|Least Squares Mean
2678585|NCT01421459|Secondary|Glycemic Variability of Fasting Blood Glucose|Glycemic variability is measured by the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning pre-meal blood glucose value from the 7-point self-monitoring blood glucose [SMBG] profiles. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|Baseline and Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline fasting blood glucose measure; last observation carried forward (LOCF).|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2678586|NCT01421459|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) Profiles|Seven-point SMBG are completed at the following timepoints: Morning (AM) Pre-Meal, Morning (AM) Post-Prandial (PP), Midday (MD) Pre-Meal, Midday PP, Evening (EV) Pre-Meal, Bed Time and 0300 hours. PP glucose is measured 2 hours (hrs) after the start of the meal. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection, and treatment.|Baseline and Endpoint [up to 24 weeks (wk)]|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline SMBG measure; last observation carried forward (LOCF).|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2678587|NCT01421459|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c)|HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.|Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks|All randomized participants who received at least 1 dose of study drug with Baseline and at least 1 post-Baseline HbA1c measure.|||percentage of HbA1c||Standard Error|Least Squares Mean
2678588|NCT01421459|Secondary|Change From Baseline in Insulin Antibody Levels|Blood samples are collected from participants and percentage of insulin antibody binding measured. Least Squares (LS) means are determined by analysis of covariance (ANCOVA) and adjusted for Baseline of response and treatment.|Baseline and 4 weeks and 12 weeks and Endpoint (24 weeks and up to 24 weeks)|All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline insulin antibody measure; last observation carried forward (LOCF).|||percentage of insulin antibody binding||Standard Error|Least Squares Mean
2678589|NCT01421459|Primary|Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)|HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.|Baseline, Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug and with a Baseline and at least 1 post-Baseline HbA1c measure; last observation carried forward (LOCF).|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2678590|NCT01421355|Primary|Change in Brachial Artery Diameter|The primary endpoint is the difference in the change in brachial artery diameter in response to a flow stimulus at visit 2 and 3. It is anticipated that a response will occur following atazanavir therapy compared with baseline. The principal secondary endpoints are the serum measures of oxidant stress and antioxidant capacity.|Day 0 and Day 4||||percentage of dilation||Standard Deviation|Mean
2678666|NCT01420289|Secondary|Percent Improvement in Peak Walking Time|Percentage Improvement in the amount of time one can walk without pain|16 weeks||||Percentage Change||Standard Error|Mean
2678667|NCT01420289|Primary|Mean Percent Reduction in Wound Surface Area||baseline and 16 weeks||||Percent reduction in wound surface area||Standard Error|Mean
2678591|NCT01421342|Secondary|Rate of Protocol Response Measured as a Change in Clinical Global Impression (CGI) - Improvement Scale|Clinical assessment of a participant's level of depression and treatment response assessed by the Clinical Global Impression - Improvement (CGI -I) Scale, a 7-point clinician rating scale of improvement from baseline in severity of depression (Guy 1976). A secondary outcome measure of response was defined as achieving a score of 2 (much improved) or 1 (very much improved).|During acute phase (up to 12 weeks)|Whole randomized cohort by intent-to-treat|||Participants|||Count of Participants
2678592|NCT01421342|Secondary|Rate of Protocol Response as Reduction in Symptoms of Major Depression (>= 50% Reduction in QIDS-C)|Response measured as reduction in symptom score for major depression defined as: 1. a reduction in QIDS-C16 of 50% or greater|During acute phase (up to 12 weeks)||||Participants|||Count of Participants
2678593|NCT01421342|Secondary|Rate of Protocol Relapse of Symptoms of Major Depression After Achieving Remission in the Acute Phase|Relapse in symptoms of major depression defined as a QIDS-C16 => 11 among those achieving remission in the acute phase.|Within 36 weeks after randomization (initiation of treatment)|The Analysis Population is the cohort of participants who met the criteria for protocol remission during the Acute Phase (first 12 Weeks of follow-up)|||Participants|||Count of Participants
2678594|NCT01421342|Primary|Rate of Protocol Remission of Symptoms of Major Depressive Disorder|Remission of symptoms of major depression during the acute treatment phase (12 weeks) defined as a sustained clinician-rated Quick Inventory of Depressive Symptoms (QIDS-C16) of <= 5 for two consecutive visits.|During acute phase (12 weeks)||||Participants|||Count of Participants
2678595|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Correlation coefficient between change from baseline in WPAI-AS and EQ-5D VAS score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||Correlation coefficient|||Number
2678596|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life (EQ-5D) Visual Analog Scale (VAS) Score at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. Correlation coefficient between WPAI-AS and EQ-5D VAS score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.|||Correlation coefficient|||Number
2678597|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS during 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers=greater impairment, less productivity. EQ-5D:participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility,self-care,usual activities,pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state [no problems], 3=worst health state [confined to bed]). Correlation coefficient between change from baseline in WPAI-AS and EQ-5D total score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||Correlation coefficient|||Number
2678598|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Euro Quality of Life-5 Dimensions (EQ-5D) Total Score at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS during 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers=greater impairment, less productivity. EQ-5D:participant rated questionnaire to assess health-related quality of life in terms of single utility score. Health state profile component assesses level of current health for 5 domains: mobility,self-care,usual activities,pain/discomfort and anxiety/depression; Scale range 1 to 3 (1=better health state [no problems], 3=worst health state [confined to bed]). Correlation coefficient between WPAI-AS and EQ-5D total score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.|||Correlation coefficient|||Number
2678599|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Month 6 and 24|WPAI-AS:6-item questionnaire to determine amount of absenteeism,presenteeism,work productivity loss,daily activity impairment attributable to AS during 7 days prior to each visit.It yields 4 sub-scores:work time missed(absenteeism),impairment while working(presenteeism),overall work impairment(work productivity), activity impairment(daily activity impairment).Sub-scores transformed to impairment percentages(range 0 to 100), higher numbers=greater impairment,less productivity.SF-36:standardized survey evaluating 8 aspects of functional health,well being(physical,social functioning; physical,emotional role limitations; bodily pain; general health; vitality; mental health).8 aspects summarized as PCS and MCS. Scores normalized to United States population to have mean=50,standard deviation=10(norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between change from baseline in WPAI-AS and MCS score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||Correlation coefficient|||Number
2678600|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Mental Component Summary Score (MCS) at Baseline|WPAI-AS: 6-item questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment attributable to AS during 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity), activity impairment (daily activity impairment). Sub-scores transformed to impairment percentages (range 0 to 100), higher numbers=greater impairment,less productivity. SF-36:standardized survey evaluating 8 aspects of functional health, well being (physical, social functioning; physical, emotional role limitations; bodily pain; general health; vitality; mental health). 8 aspects summarized as PCS and MCS. Scores normalized to United States population to have mean=50, standard deviation=10 (norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between WPAI-AS and MCS score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.|||Correlation coefficient|||Number
2678601|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Month 6 and 24|WPAI-AS:6-item questionnaire to determine amount of absenteeism,presenteeism,work productivity loss,daily activity impairment attributable to AS during 7 days prior to each visit.It yields 4 sub-scores:work time missed(absenteeism),impairment while working(presenteeism),overall work impairment(work productivity),activity impairment(daily activity impairment).Sub-scores transformed to impairment percentages(range 0 to 100),higher numbers=greater impairment,less productivity.SF-36:standardized survey evaluating 8 aspects of functional health,well being(physical,social functioning; physical,emotional role limitations; bodily pain; general health; vitality; mental health).8 aspects summarized as PCS and MCS. Scores normalized to United States population to have mean=50,standard deviation=10 (norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between change from baseline in WPAI-AS and PCS score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||Correlation coefficient|||Number
2678602|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Baseline|WPAI-AS:6-item questionnaire to determine amount of absenteeism,presenteeism,work productivity loss,daily activity impairment attributable to AS during 7 days prior to each visit.It yields 4 sub-scores:work time missed(absenteeism),impairment while working(presenteeism),overall work impairment(work productivity), activity impairment(daily activity impairment).Sub-scores transformed to impairment percentages(range 0 to 100), higher numbers=greater impairment,less productivity.SF-36:standardized survey evaluating 8 aspects of functional health,well being(physical,social functioning; physical,emotional role limitations; bodily pain; general health; vitality; mental health).8 aspects summarized as PCS and mental component summary (MCS).Scores normalized to United States population to have mean=50,standard deviation=10 (norm based scoring with <50=lower level of functioning and >50=higher level of functioning). Correlation coefficient between WPAI-AS and PCS score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.|||Correlation coefficient|||Number
2678603|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BAS-G is used to indicate the effect of disease on participant's well-being. This scale is composed of 2 items ranging from 0 = very good to 10 =very bad. Total score ranges from 0 to 10: the higher the BAS-G score, the worse the participant's health status. Correlation coefficient between change from baseline in WPAI-AS and BAS-G score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||Correlation coefficient|||Number
2680014|NCT01405794|Primary|Change in Carbon Dioxide Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 days||||mmol/L||Standard Deviation|Mean
2678604|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Global Score (BAS-G) at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BAS-G is used to indicate the effect of disease on participant's well-being. This scale is composed of 2 items ranging from 0 = very good to 10 =very bad. Total score ranges from 0 to 10: the higher the BAS-G score, the worse the participant's health status. Correlation coefficient between WPAI-AS and BAS-G score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.|||Correlation coefficient|||Number
2678605|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Final score ranges from 0 to 10: the higher the BASMI score, the more severe the participant's limitation of movement due to their AS. Correlation coefficient between change from baseline in WPAI-AS and BASMI score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||Correlation coefficient|||Number
2678606|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Metrology Index (BASMI) Total Score at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Final score ranges from 0 to 10: the higher the BASMI score, the more severe the participant's limitation of movement due to their AS. Correlation coefficient between WPAI-AS and BASMI score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.|||Correlation coefficient|||Number
2678607|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 6 and 24|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASFI:validated self-assessment tool to determine degree of functional limitation in AS. Utilizing a scale of 0-10(0=easy, 10=impossible),participants answered 10 questions assessing ability in completing normal daily activities/physically demanding activities. BASFI total score=mean score of 10 questions (range: 0 to 10, higher score=more severity). Correlation coefficient between change from baseline in WPAI-AS and BASFI score at Month 6, 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at visit 1 (baseline), started the treatment with etanercept and had at least one visit during follow-up. Here 'n' signifies those participants who were evaluable at specified time points for the given sub-scale items.|||Correlation coefficient|||Number
2678608|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Baseline|WPAI-AS:6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment due to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed(absenteeism), impairment while working(presenteeism), overall work impairment(work productivity), activity impairment(daily activity impairment). These sub-scores are transformed to impairment percentages(range 0 to 100), with higher numbers indicating greater impairment, less productivity. BASFI:validated self-assessment tool to determine degree of functional limitation in AS. Utilizing a scale of 0-10(0=easy, 10=impossible),participants answered 10 questions assessing ability in completing normal daily activities/physically demanding activities. BASFI total score=mean score of 10 questions (range: 0 to 10, higher score=more severity). Correlation coefficient between WPAI-AS and BASFI score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.|||Correlation coefficient|||Number
2678668|NCT01420146|Secondary|HER2 Extracellular Domain|evaluate the concentration of circulating HER2 extracellular domain in the blood and study his possible role as on imaging quality|within 60 min before tracer injection|||||||
2678609|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 6 and Month 24|WPAI-AS: 6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment attributable to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity), activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. BASDAI: validated self-assessment tool to determine disease activity in participants with AS. Utilizing a scale of 0-10 (0=none and 10=very severe), participants answered 6 questions measuring discomfort, pain, fatigue. The BASDAI total score averages the individual assessments and ranges from 0-10 (0=none, 10=very severe). Correlation coefficient between change from baseline in WPAI-AS and BASDAI score at Month 6 and 24 was reported.|Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||Correlation coefficient|||Number
2678610|NCT01421303|Secondary|Correlation Between Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Baseline|WPAI-AS: 6-question participant rated questionnaire to determine amount of absenteeism, presenteeism, work productivity loss, daily activity impairment attributable to AS for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity), activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. BASDAI: validated self-assessment tool to determine disease activity in participants with AS. Utilizing a scale of 0-10 (0=none and 10=very severe), participants answered 6 questions measuring discomfort, pain, fatigue. The BASDAI total score averages the individual assessments and ranges from 0-10 (0=none, 10=very severe). Correlation coefficient between WPAI-AS and BASDAI score at baseline was reported.|Baseline|BAS consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given scale item at baseline.|||Correlation coefficient|||Number
2678611|NCT01421303|Secondary|Change From Baseline in Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6 and 24|WPAI: AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis (AS) for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline, Month 6, Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable at the specified time points for the given sub-scale items.|||Percentage of impairment||Standard Deviation|Mean
2678612|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 24|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Month 24|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 24.|||Percentage of impairment||Standard Deviation|Mean
2678613|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 18|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Month 18|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 18.|||Percentage of impairment||Standard Deviation|Mean
2678614|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 12|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Month 12|FAS consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 12.|||Percentage of impairment||Standard Deviation|Mean
2680015|NCT01405794|Primary|Change in Chloride Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 days||||mmol/L||Standard Deviation|Mean
2678615|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Month 6|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Month 6|Follow-up analysis set (FAS) consisted of all participants enrolled in the study, who were seen at baseline, started the treatment with etanercept and had at least 1 visit during follow-up. Here 'n' signifies those participants who were evaluable for the given sub-scale items at Month 6.|||Percentage of impairment||Standard Deviation|Mean
2678616|NCT01421303|Primary|Work Productivity and Activity Impairment Questionnaire - Ankylosing Spondylitis (WPAI-AS) Scale Scores at Baseline|WPAI-AS is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.|Baseline|Baseline analysis set (BAS) consisted of all participants enrolled in the study, who were seen at baseline and started the treatment with etanercept (Enbrel). Here 'n' signifies those participants who were evaluable for the given sub-scale items at baseline.|||Percentage of impairment||Standard Deviation|Mean
2678617|NCT01421277|Primary|Main Reason for Stopping Triptan Use||Up to 3 months|All screened participants who were fully eligible for the study.|||Number of partiicpants|||Number
2678618|NCT01421277|Primary|Number of Participants Continuing Triptan Therapy|Participants reported information online. For this measure, the number of participants who continued to use a triptan after the first migraine attack were counted; switching from one triptan to another was considered continued use.|Up to 3 monoths|All screened participants who were fully eligible for the study.|||Number of participants|||Number
2678619|NCT01421277|Primary|Number of Participants Using a Triptan for Migraine Attacks|Participants reported information online. For this measure, the number of participants who used at least one dose of any newly prescribed triptan for the first time in response to a migraine attack were counted.|Up to 3 months|All screened participants who were fully eligible for the study.|||Number of participants|||Number
2678620|NCT01421225|Secondary|Pre-lunch Blood Glucose Level|Blood glucose levels were documented at 12 pm just prior to being served lunch.|Participants will be followed for the duration of the 48 hour protocol||||mg/dL||Standard Error|Mean
2678621|NCT01421225|Secondary|Number of Interventions for Hypoglycemia|The number of interventions for hypoglycemia between 10 PM - 8 AM.|Participants will be followed for the duration of the 48 hour protocol||||Interventions|||Number
2678622|NCT01421225|Secondary|Post-prandial Glycemic Control|Peak post-prandial blood sugar between 8 AM and noon|Participants will be followed for the duration of the 48 hour protocol||||mg/dL||Standard Error|Mean
2678623|NCT01421225|Primary|Nocturnal Glycemic Control|Time spent within target glucose range based on the glucose meter measurements between 10 PM and 8 AM. The target range is 110-200 mg/dl as this is the American Diabetes Association defined target overnight range for this age group.|Participants will be followed for the duration of the 48 hour protocol.||||Hours||Standard Error|Mean
2678624|NCT01421147|Secondary|Rate Per 30 Days of Hypoglycemic Events|The rate of hypoglycemic events per 30 days is defined as the total number of events between visits divided by the actual number of days between visits, and then multiplied by 30 days. A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has blood glucose (BG) concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines (ADA 2005). Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.|Baseline through 24 weeks (wk) and 52 weeks|All randomized participants who received at least 1 dose of study drug.|||hypoglycemic events per 30 days||Standard Deviation|Mean
2678625|NCT01421147|Secondary|Incidence of Hypoglycemic Events|Incidence of hypoglycemic events is defined as the number of hypoglycemic events. A hypoglycemic event is defined as any time a participant feels that he/she is experiencing a sign or symptom that is associated with hypoglycemia, or has a blood glucose (BG) concentration of ≤ 70 milligrams/deciliter [mg/dL (3.9 millimoles/liter (mmol/L)], even if it was not associated with signs, symptoms, or treatment consistent with current guidelines [American Diabetes Association (ADA) 2005]. Severe hypoglycemia is defined as a hypoglycemic event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions (these episodes may be associated with sufficient neuroglycopenia to induce seizure or coma; also, BG measurements may not be available during such an event). Nocturnal hypoglycemia is defined as any hypoglycemic event that occurs between bedtime and waking.|Baseline through 24 weeks (wk) and 52 weeks|All randomized participants who received at least 1 dose of study drug.|||events|||Number
2678626|NCT01421147|Secondary|Percentage of Participants With Hemoglobin A1c (HbA1c) <7.0% and HbA1c ≤6.5%|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. The percentage of participants with Hemoglobin A1c (HbA1c) <7.0% or HbA1c ≤6.5% is calculated as the number of participants with an HbA1c level of the cut-off value (<7.0% or ≤6.5%) divided by the number of participants treated, then multiplied by 100.|Baseline and 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoints (up to 24 weeks and up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline HbA1c measurement. Last observation carried forward (LOCF) principle was used for Endpoints (up to 24 weeks and up to 52 weeks).|||percentage of participants|||Number
2678627|NCT01421147|Secondary|Insulin Dose - Units [Total and by Component [Basal and Bolus (Lispro)])|Units of insulin taken daily were presented. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Endpoints [up to 24 weeks (wk) and up to 52 weeks]|All randomized participants who received at least 1 dose of study drug and had at least 1 insulin daily dose measurements. Last observation carried forward (LOCF) principle was used.|||units of insulin per day (U/day)||Standard Error|Least Squares Mean
2678628|NCT01421147|Secondary|Insulin Dose Per Body Weight (U/kg) (Total and by Component [Basal and Bolus (Lispro)])|Total daily insulin dose was adjusted for body weight [units of insulin/kilogram/day (U/kg/day)]. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Endpoints [up to 24 weeks (wk) and up to 52 weeks]|All randomized participants who received at least 1 dose of study drug and had at least 1 daily insulin dose per body weight measurements. Last observation carried forward (LOCF) principle was used.|||U/kg/day||Standard Error|Least Squares Mean
2678629|NCT01421147|Secondary|Insulin Treatment Satisfaction Questionnaire (ITSQ)|ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. Items divided into 5 domains: Inconvenience of Regimen [(IR) 5 items: scores range 5-35], Lifestyle Flexibility [(LF) 3 items: scores range 3-21], Glycemic Control [(GC) 3 items: scores range 3-21], Hypoglycemic Control [(HC) 5 items: scores range 5-35], Insulin Delivery Device [(IDD) 6 items: scores range 6-42]. ITSQ Total Overall Scores range from 22-154. Data presented are the transformed score on a scale of 0-100, where transformed score=100×[(7-raw score)/6]. Higher scores indicate better treatment satisfaction. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline and 24 weeks and Endpoint (up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline ITSQ measurements. Last observation carried forward (LOCF) principle was used for Endpoint (up to 52 weeks).|||units on a scale||Standard Error|Least Squares Mean
2678630|NCT01421147|Secondary|Adult Low Blood Sugar Survey (ALBSS)|"ALBSS contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (almost always). Items are categorized in 2 domains: Behavior (or avoidance) Items 1 to 15 and Worry (or affect) Items 16 to 33. Behavior Total Score (TS) range is 0 to 60 and Worry TS range is 0 to 72. Higher scores on Behavior items (related to avoidance of hypoglycemia) reflect greater awareness and/or effort of the participant to prevent low blood sugar. Higher scores on Worry items (related to worries about low blood sugar and its consequences) reflect greater participant concern about having low blood sugar. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country."|Baseline and 24 weeks and Endpoint (up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline ALBSS measurement. Last observation carried forward (LOCF) principle was used for Endpoint (up to 52 weeks).|||units on a scale||Standard Error|Least Squares Mean
2678631|NCT01421147|Secondary|Change From Baseline in Body Weight|Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline, 6 weeks and 12 weeks and 18 weeks and Endpoints (up to 24 weeks and up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline body weight measurement. Last observation carried forward (LOCF) principle was used for Endpoints (up to 24 weeks and up to 52 weeks).|||kilogram (kg)||Standard Error|Least Squares Mean
2678632|NCT01421147|Secondary|Glycemic Variability of Fasting Blood Glucose|Glycemic variability is the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning premeal blood glucose value from the 7-point self-monitoring blood glucose (SMBG) profiles. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline and Endpoints (up to 24 weeks and up 52 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline fasting blood glucose measurement. Last observation carried forward (LOCF) principle was used.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2678633|NCT01421147|Secondary|7-Point Self-Monitored Blood Glucose (SMBG) Profiles|7-point SMBG measurements are completed at the following timepoints: Morning (AM) Pre-Meal, AM Post-Prandial (PP), Midday (MD) Pre-Meal, MD PP, Evening (EV) Pre-Meal, Bed Time and 0300 hours. PP glucose is measured 2 hours (hrs) after the start of the meal. Values for the 7-point SMBG profiles were averaged over the three 7-point SMBG profiles during 2-week period prior to each visit. If only 1 of the 3 days of data was collected, then the value of the 1 day was used. If only 2 of the 3 days of data were collected, then the average of the 2 days was used. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline and Endpoints [up to 24 weeks (wk) and up to 52 weeks]|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline SMBG measurement. Last observation carried forward (LOCF) principle was used.|||millimoles per liter (mmol/L)||Standard Error|Least Squares Mean
2678634|NCT01421147|Secondary|Change From Baseline in Hemoglobin A1c (HbA1c)|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline, 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoint (up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline HbA1c measurements. Last observation carried forward (LOCF) principle was used for Endpoint (up to 52 weeks).|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2680016|NCT01405794|Primary|Change Potassium Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 days||||mmol/L||Standard Deviation|Mean
2678635|NCT01421147|Secondary|Change From Baseline in Insulin Antibody Levels|Blood samples are collected from participants and percentage of insulin antibody binding was measured to determine the insulin antibody levels. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline hemoglobin A1c (HbA1c), treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline, 6 weeks and 12 weeks and Endpoints (up to 24 weeks and up to 52 weeks)|All randomized participants who received at least 1 dose of study drug and were insulin antibody positive at baseline and had at least 1 post-baseline insulin antibody positive measurement. Last observation carried forward (LOCF) principle was used for Endpoints (up to 24 and up to 52 weeks).|||percentage of insulin antibody binding||Standard Error|Least Squares Mean
2678636|NCT01421147|Primary|Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)|HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.|Baseline, Endpoint (up to 24 weeks)|All randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline HbA1c measurement. Last observation carried forward (LOCF) principle was used.|||percentage of glycosylated hemoglobin||Standard Error|Least Squares Mean
2678637|NCT01421134|Secondary|Percentage of Subjects Who Achieve a Remission, Defined as a Montgomery-Asberg Depression Rating Scale (MADRS) Total Score of ≤ 12 at Week 6 (LOCF)||Baseline to Week 6|Intent to treat population|||percentage of subjects|||Number
2678638|NCT01421134|Secondary|Percentage of Subjects Who Achieve a Response, Defined as ≥ 50% Reduction From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6 (LOCF).||Baseline to Week 6|Intent to treat population|||percentage of subjects|||Number
2678639|NCT01421134|Secondary|Mean Change From Baseline to Week 6 in the Hamilton Rating Scale for Anxiety(HAM-A) Total Score|The HAM-A is used to quantify the severity of anxiety symptomatology and consists of 14 items. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe/disabling). The HAM-A total score is calculated as the sum of the 14 individual items and ranges from 0 to 56. Higher scores are associated with greater degree of anxiety.|Baseline to Week 6|Intent to treat population. 3 Lurasidone subjects and 2 placebo subjects did not have post-baseline HAM-A assessment.|||units on a scale||Standard Error|Least Squares Mean
2678640|NCT01421134|Secondary|Mean Change From Baseline to Week 6 in the Sheehan Disability Scale (SDS) Total Score|The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors (work/school, social life/leisure, and family life/home responsibility) in the patient's life are impaired by depressive symptoms. These three items are responded to on a visual analogue scale (VAS) ranging through 0 (no impairment), 1-3 (mild), 4-6 (moderate), 7-9 (marked) and 10 (extreme) disability. The SDS total score is calculated as the sum of the three items and ranges from 0 (unimpaired) to 30 (highly impaired).|Baseline to Week 6|Intent to treat population: If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.|||units on a scale||Standard Error|Least Squares Mean
2678641|NCT01421134|Secondary|Mean Change From Baseline to Week 6 in the Young Mania Rating Scale (YMRS) Total Score|The YMRS is an 11-item clinician-rated instrument used to assess the severity of mania. Seven items are rated on a 5-point scale, ranging from 0 to 4, and four items are rated on a 9-point scale, ranging from 0 to 8. The YMRS total score is calculated as the sum of the 11 individual items and ranges from 0 to 60. Higher scores are associated with greater severity of mania.|Baseline to Week 6|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
2678642|NCT01421134|Secondary|Mean Change From Baseline to the 6-week Study Endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) Score|The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.|Baseline to Week 6|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
2678643|NCT01421134|Primary|Mean Change From Baseline to the 6-week Study Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Scores|"The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity."|Baseline to Week 6|Intent to treat population|||units on a scale||Standard Error|Least Squares Mean
2678644|NCT01420965|Secondary|Determine Whether the Combination of Low Dose-Cyclophosphamide and Anti PD1 Monoclonal Antibodies (CT-011) With Provenge(tm) Lead to Improvement in Increase Progression Free Survival (PFS) and Overall Survival (OS) in Patients With Advanced, Min...||2 years|Study discontinued due to drug supply issues; no analysis performed or meaningful data derived.||||||
2678645|NCT01420965|Primary|Determine Feasibility of Provenge Plus Low-dose Cyclophosphamide as Well as the Immune Efficacy of Provenge Alone Versus Provenge Plus Low-dose Cyclophosphamide and Anti PD1 Monoclonal Antibodies (CT011) on the Change in Specific Immune Response.||2 years|Study discontinued due to drug supply issues; no analysis performed or meaningful data derived.||||||
2678646|NCT01420926|Secondary|Adverse Events|Adverse Events: Incidence of adverse events, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Adverse events were collected every cycle during treatment and up to one month after treatment. Adverse events were summarized using summary statistics and frequency tables for each separate cohort. Per protocol, analysis was descriptive in nature. In this section, the number of patients that reported a grade 4 or higher event are summarized. A complete listing of Adverse Events is provided in the Adverse Events section below.|Duration of treatment|The 4 participants were not evaluated for adverse events were excluded from this analysis.|||participants|||Number
2678647|NCT01420926|Secondary|Progression-free Survival|Progression free survival (PFS) was defined as the time from study entry to progression or death. Progression free and surviving patients were censored at the date of last follow-up. The median DFS with 95% CI was estimated using the Kaplan Meier method.|Time from study entry to progression and/or death (up to 10 years)||||months||95% Confidence Interval|Median
2678669|NCT01420146|Secondary|Time Activity Curve|Time activity curve of normal organ and tumor lesions: pharmacokinetic|blood sample at 5, 15, 30, 60 minutes, 1 day, 2 days and 4 or 6 days after tracer injection. Images : Day 0, Day 2 and Day 4 or 6|||||||
2678648|NCT01420926|Secondary|Disease-free Survival (DFS)|Disease free survival (DFS) was defined as the time from CR to relapse or death. Relapse free and surviving patients were censored at the date of last follow-up. The median DFS with 95% CI was estimated using the Kaplan Meier method. Relapse is defined as the reappearance of blood blasts or >= 5% marrow blasts after achieving a CR or CRi.|Time from study entry to relapse and/or death (up to 10 years)|Only participants who achieved a CR are included in this analysis.|||months||95% Confidence Interval|Median
2678649|NCT01420926|Secondary|Complete Remission Rate (CR and CRi)|Defined as the number of patients who achieve a CR or CRi divided by the total number of evaluable patients. A Complete remission (CR) requires: <5% marrow blast, > 200 nucleated cells, no blasts with auer rods, no extramedullary disease, ANC >1,000/mm^3 and platelets > 100,000/mm^3. A CR with incomplete blood count recovery (CRi) is defined as CR with exception of ANC < 1,000/mm^3 or platelets < 100,000/mm^3.|Duration of study up to 10 years||||percentage of participants||95% Confidence Interval|Number
2678650|NCT01420926|Primary|Overall Survival (OS) Time|Overall survival (OS) was defined as the time from study entry to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Time from study entry to death assessed up to 10 years||||months||95% Confidence Interval|Median
2678651|NCT01420848|Secondary|Students Anxiety Levels|The State-Trait Anxiety Inventory consists of 2 scales, each one containing 20 items. One of the scales evaluates state anxiety, characterized by subjective feelings of tension and apprehension, followed by autonomic nervous system responses at a given moment. Trait anxiety, assessed by the other scale, refers to a relatively stable tendency to perceive situations at threatening and react anxiously to them. The scores are divided into low, moderate, high and very high and are determined by the sum of 20 symptoms from a 5-point Likert-type scale.The range of scores is 20-80, the higher the score indicating greater anxiety for both the Trait and State Anxiety.|90 days|It was analysed only the number of participants that ended the study.|||units on a scale||Standard Deviation|Mean
2678652|NCT01420848|Primary|Students Stress Levels|The List of Symptoms of Stress is an evaluation questionnaire which consists of a list of 59 psycho-physiological and psychosocial stress, in which the subject must associate to each symptom of the four answers: never (0), rarely (1 ), often (2) or always (3). The scores are added together and the answers provide the level of stress the individual.In this questionnaire to score from 0 to 11 is void, 12 to 29 (low level), 30 to 59 (medium level), 60 to 120 (high level) and 120 to 177, very high level. Participants below 29 points were excluded.|90 days|It was analysed only the subjects that ended the study.|||units on a scale||Standard Deviation|Mean
2678653|NCT01420653|Primary|SPID (Summed Pain Intensity Differences)|"The time-adjusted Summed Pain Intensity Differences (SPIDs) of the VAS pain intensity scores up to 48 hours after the first dose of study medication.~This was calculated from the visual analogue scale (VAS) pain intensity scores recorded during the 48 hours double blind treatment period, with the last measure taken just prior to the final dose of blinded study medication. The visual analogue scale is 100mm long with 0= no pain and 100=worst pain imaginable. The Visual Analogue Scale It is expected that treatments which can provide superior analgesic effect will demonstrate a greater Summed Pain Intensity Difference."|48 hours afte the first dose|Primary Efficacy Endpoint was analyzed in ITT population (subjects who have been randomized and received the first dose of study medication)|||score on a scale||Standard Error|Mean
2678654|NCT01420627|Secondary|Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period|Number of patients with total erythrocyte dAXP concentration from a trough blood sample <0.02 mmol/L|From Week 34 to End of Study/Early Discontinuation, up to 203 weeks|Completer|||Participants|||Count of Participants
2678655|NCT01420627|Secondary|Duration of Hospitalization||Through end of EZN-2279 study treatment, up to 203 weeks|As-treated population who were hospitalized|||Days|Number of hospitalizations (3 patients)|Standard Deviation|Mean
2678656|NCT01420627|Secondary|Number of Patients With Infections and Hospitalizations|Infections were documented clinically with signs and symptoms without microbiologic cultures or with positive viral or bacterial cultures|Through end of EZN-2279 study treatment, up to 203 weeks|As-treated|||Participants|||Count of Participants
2678657|NCT01420627|Secondary|Summary of Trough dAXP Levels in EZN-2279 Maintenance Period|Trough dAXP levels, mmol/L|Through end of EZN-2279 study treatment, up to 203 weeks|Completer|||mmol/L||Full Range|Median
2678658|NCT01420627|Secondary|Summary of Trough dAXP Levels in EZN-2279 Treatment Period|Trough dAXP levels, mmol/L|From Baseline through Week T-21|Completer|||mmol/L||Full Range|Median
2678659|NCT01420627|Secondary|Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period|Trough ADA activity levels, mmol/h/L|Through end of EZN-2279 study treatment, up to 203 weeks|Completer|||mmol/h/L||Full Range|Median
2678660|NCT01420627|Secondary|Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period|Trough ADA activity, mmol/h/L|From Baseline through Week T-21|Completer|||mmol/h/L||Full Range|Median
2678661|NCT01420627|Secondary|Safety Summary Data|Summary of adverse events and serious adverse events|Through end of EZN-2279 study treatment, up to 203 weeks|As-treated|||Participants|||Count of Participants
2678662|NCT01420627|Primary|Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period|Number of patients with total erythrocyte dAXP concentration from a trough blood sample <0.02 mmol/L|Baseline through Week T-21|Completer|||Participants|||Count of Participants
2678663|NCT01420549|Primary|Reduction of LDL Cholesterol Levels|The primary efficacy variable was the percentage of LDL-C variation at the end of nine weeks of treatment, compared to baseline (pre-randomization), in participants who achieved LDL <100 mg/dL were considered to have been successfully treated.|Baseline compared to the end of 9 weeks of treatment|All randomized participants who received at least one dose of study treatment.|||percent change of LDL||95% Confidence Interval|Least Squares Mean
2678664|NCT01420289|Secondary|Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain.|Percent change (improvement)in mean VAS pain scores at baseline and at 16 weeks|16 weeks||||Percent improvement in mean VAS pain sco||Standard Error|Mean
2678665|NCT01420289|Secondary|Perceived Improvement in Physical Function After 16 Weeks|"Percent improvement in SF-36 Quality of life (QOL) questionnaire score at baseline and at week-16.~The higher the score on the SF-36 questionnaire the better the QOL."|16 weeks||||Percent improvement in Sf-36 QOL score||Standard Error|Mean
2719665|NCT01102257|Primary|Change on Ocular Surface Disease Index (OSDI)||90 +/- 14 days following initiation of drug regimen|||||||
2678670|NCT01420146|Primary|Test the Diagnostic Accuracy of the HER2 Imaging Using the Labelled Monoclonal Antibody Trastuzumab by Correlating the HER2 PET/CT Imaging With the FDG-PET/CT and Molecular Characterization of Tumor Samples With Discordant Image Findings|"A visual 'patient-based' classification capturing the whole disease burden was developed by using a side-by-side display, comparing baseline FDG-PET/CT(showing all FDG-positive mets independent of their HER2-imaging status) & day4 HER2-PET/CT. Pts were grouped into 4 HER2-PET/CT patterns according to the proportion of FDG avid tumour load showing relevant 89Zr-T uptake. Pattern A: entire tumor load showed pertinent tracer uptake; B: dominant part of tumour load showed tracer uptake; C: minor part of tumor load showed tracer uptake; D: entire tumor load lacked tracer uptake. Patterns A+B='HER2-positive' & C+D='HER2-negative'. In the 20 pts: 4 pts were classified A, 5B, 1C & 10D. This classification indicates substantial heterogeneity of 89Zr-T uptake within this so called 'HER2-positive' pt population. After dichotomization, 11(55%) pts were considered as HER2-PET/CT negative. Furthermore, HER2-PET/CT revealed intrapatient heterogeneity of tumour uptake(pts classified B or C)."|4 years||||Participants|||Count of Participants
2678671|NCT01420081|Secondary|Summary of Treatment-related TEAEs|"Safety of subject in terms of number of participants with treatment related AEs.~Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm."|From baseline (-3 days) until 35 days post last dose|Participants were analyzed on safety analysis set which was defined as all enrolled patients who started treatment.|||Number of participants|||Number
2678672|NCT01420081|Secondary|Number of Treatment-related TEAEs|"Safety of subject in terms of number of participants with treatment related AEs.~Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm."|From baseline (-3 days) until 35 days post last dose|Participants were analyzed on safety analysis set which was defined as all enrolled patients who started treatment.|||Number of AEs|||Number
2678673|NCT01420081|Secondary|Summary of Treatment-emergent Adverse Events (TEAEs) - All Causalities|Safety of participants in terms of TEAEs. Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm.|From baseline (-3 days) until 35 days post last dose|Participants were analyzed on safety analysis set which was defined as all enrolled patients who started treatment.|||Number of participants|||Number
2678674|NCT01420081|Secondary|Number of Treatment-emergent Adverse Events (TEAEs) - All Causalities|Safety of participants in terms of TEAEs. Note: One subject treated with PF-05212384 had the stathmin status changed after randomization and was categorized under the corresponding arm.|From baseline (-3 days) until 35 days post last dose|Participants were analyzed on safety analysis set which was defined as all enrolled patients who started treatment.|||Number of AEs|||Number
2678675|NCT01420081|Secondary|Steady State Volume of Distribution (Vss) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.|||Litres||Geometric Coefficient of Variation|Geometric Mean
2678676|NCT01420081|Secondary|Clearance (CL) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.|||L/hr||Geometric Coefficient of Variation|Geometric Mean
2678677|NCT01420081|Secondary|Time for Cmax (Tmax) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.|||hours||Full Range|Median
2678678|NCT01420081|Secondary|Terminal Elimination Half Life (t½) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.|||hours||Standard Deviation|Mean
2678679|NCT01420081|Secondary|Maximum Plasma Concentration (Cmax) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2678680|NCT01420081|Secondary|Area Under the Serum Concentration Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.|||ng.hr/mL||Geometric Coefficient of Variation|Geometric Mean
2678681|NCT01420081|Secondary|Area Under the Serum Concentration Time Profile From Time Zero Extrapolated to Infinity (AUCinf) of PF-05212384 at Each Specified Time Points.||Pre-dose: 0 hours, and Post dose: 0.5 (after end of infusion), 1, 2, 4, 6, 24, 72, and 120 hours at Day 1|Participants were analyzed on PK parameter analysis set which was defined as all treated patients who had at least one of the PK parameters of interest estimated.|||ng.hr/mL||Geometric Coefficient of Variation|Geometric Mean
2678690|NCT01420081|Secondary|Percentage of Participants With Progression Free Survival (PFS) at 6 Months for PF-05212384|Progression free survival is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the probability of remaining progression-free at 6 months (based on Kaplan-Meier estimates). Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions.|6 months|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.|||Percentage of participants||95% Confidence Interval|Number
2680017|NCT01405794|Primary|Change Sodium Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||mmol/L||Standard Deviation|Mean
2678682|NCT01420081|Secondary|Percentage of Participants in Each Treatment Arm With Gene and/or Protein Expression Biomarkers- PIK3CA Amplification, KRAS Mutation P/N, KRAS Mutation OBSV, PTEN Stroma Manual Score, PTEN Tumor Manual Score, KRAS SCC and Stathmin H/L,Tissue.|"Gene and/or protein expression biomarkers in biopsied tumor tissue relating to PI3K and/or mTOR pathway activation, such as PIK3CA and PIK3R1 mutations, Phosphatase And Tensin Homolog (PTEN) protein levels, and PIK3CA gene amplification were to be assessed.~Stained tissues were evaluated by a board-certified pathologist who provided a manual pathology score (i.e., 0, 1+, 2+, or 3+) and, if appropriate, comments upon the staining of the specimen.~The directionality increases from 0 to 3+ with 0 being no staining for PTEN by IHC and 3+ being high staining intensity for PTEN."|Baseline and Cycle1 to Cycle 5 where each cycle consist of 28 days|Participants were analyzed as the molecular profiling tumor analysis set was defined as all enrolled patients who started treatment and had baseline tumor tissues (archived paraffin block or unstained slides or fresh tumor tissue sample) successfully analyzed for at least one of the biomarkers.|||Percentage of participants|||Number
2678683|NCT01420081|Secondary|Stathmin H Score [Mean (SD)] for Each Treatment Arm With Gene and/or Protein Expression Biomarkers in Biopsied Tumor Tissue|"Gene and/or protein expression biomarkers in biopsied tumor tissue relating to PI3K and/or mTOR pathway activation, such as PIK3CA and PIK3R1 mutations, PTEN protein levels, and PIK3CA gene amplification were to be assessed.~Each slide was imaged by whole slide scanning and patient samples were scored as follows:~Pathologist manual score (0, 1+, 2+, 3+) for overall staining intensity of tumor tissue.~Percentage of positive tumor cells staining at 0, 1+, 2+, and 3+.~H-score value (integer between 0 and 300) for tumor cell staining was calculated. The higher the stathmin staining, the higher the stathmin H-score."|Prior to Cycle 1 Day 1|Participants were analyzed as the molecular profiling tumor analysis set was defined as all enrolled patients who started treatment and had baseline tumor tissues (archived paraffin block or unstained slides or fresh tumor tissue sample) successfully analyzed for at least one of the biomarkers.|||Score||Standard Deviation|Mean
2678684|NCT01420081|Secondary|Level of Each Pharmacodynamic Parameter at Specified Timepoints- Triglycerides (mg/dL)|PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.|Baseline (Day -3) and Cycle1 to Cycle 3 where each cycle consist of 28 days|Participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.|||Triglycerides (mg/dL)||Standard Deviation|Mean
2678685|NCT01420081|Secondary|Level of Each Pharmacodynamic Parameter at Specified Timepoints- Cholesterol (mg/dL)|PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.|Baseline (Day -3) and Cycle1 to Cycle 3 where each cycle consist of 28 days|Participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.|||Cholesterol (mg/dL)||Standard Deviation|Mean
2678686|NCT01420081|Secondary|Level of Each Pharmacodynamic Parameter at Specified Timepoints- Glycosylated Hemoglobin (HbA1c)|PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.|Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days|participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.|||HbA1c (mg/dL)||Standard Deviation|Mean
2678687|NCT01420081|Secondary|Level of Each Pharmacodynamic Parameter at Specified Timepoints- Insulin (UIU/mL)|PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.|Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days|Participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.|||Insulin (UIU/mL)||Standard Deviation|Mean
2678688|NCT01420081|Secondary|Level of Each Pharmacodynamic Parameter at Specified Timepoints- Glucose (mg/dL)|PD biomarkers are measured at screening (baseline) and multiple time points post baseline. Baseline is defined as the last measurement prior to dosing, which is the measurement at screening or the cycle 1 day 1 pre-dose measurement if collected. This outcome measure will be updated once the data is available with the supplemental clinical study report.|Baseline (Day -3) and Cycle1 to Cycle 5 where each cycle consist of 28 days|Participants were analyzed on PD analysis set which consisted of all enrolled patients who started treatment and had a baseline as well as at least one post-baseline measurement for at least one PD biomarker. The PD biomarkers include serum glucose, insulin, HbA1c, cholesterol, and triglycerides.|||Glucose (mg/dL)||Standard Deviation|Mean
2678689|NCT01420081|Secondary|Overall Survival (OS) for PF-05212384|OS is defined as the time from the date of Cycle 1 Day 1 to the date of death.|12 months|Survival analysis was not performed as the study was terminated early. No data are available because data were not collected. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.||||||
2678748|NCT01419314|Primary|Pain Scores|A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.|Week 6|The total number of participants that completed the 6 week trial in each investigational group|||units on a scale 0-100 (0=no pain)||Standard Deviation|Mean
2678691|NCT01420081|Secondary|Progression Free Survival for PF-05212384|PFS is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the median. Approximate 95% confidence interval corresponding to this estimate was computed. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions.|From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.|||Days||95% Confidence Interval|Median
2678692|NCT01420081|Secondary|Progression Free Survival for PF-04691502|PFS is defined as the time from the date of cycle 1 day 1 to the date that objective progressive disease is documented or death due to any cause, whichever occurs first. PFS was characterized in terms of the median. Approximate 95% confidence interval corresponding to this estimate was computed. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions with a minimum absolute increase of 5 mm, or an unequivocal progression of non-target lesion, or the appearance of new lesions. On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed.|From Cycle 1 Day 1 to objective progressive disease or death due to any cause whichever occurs first (up to 12 months)|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.|||Time to Event (Days)|||Number
2678693|NCT01420081|Secondary|Percentage of Participants With Objective Response for PF-05212384|Objective response is defined as CR or PR. CR: Complete response: 2 or more objective statuses of CR a minimum of 4 weeks apart documented before PD. Partial response: 2 or more objective statuses of PR or better a minimum of 4 weeks apart documented before PD, but not qualifying as CR. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions.|Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.|||Percentage of participants||95% Confidence Interval|Number
2678694|NCT01420081|Secondary|Objective Response for PF-04691502|"Objective response is defined as CR or PR. CR: Complete response: 2 or more objective statuses of CR a minimum of 4 weeks apart documented before PD. Partial response: 2 or more objective statuses of PR or better a minimum of 4 weeks apart documented before PD, but not qualifying as CR. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions. The outcome data table below presents the number of participants with objective response as yes or no. On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed."|Randomization to objective progression, death or last tumor assessment without progression (up to 12 months)|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.|||Participants response|||Number
2678695|NCT01420081|Primary|Percentage of Participants With Clinical Benefit Response for PF-05212384|Clinical benefit response was defined as best overall response of complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks from Cycle 1 Day 1 (C1D1) to the first time of disease progression. The primary analysis is based on the clinical benefit rate which is calculated as proportion of participants with a clinical benefit response relative to total number of response evaluable participants. Per RECIST v1.1 for target lesions: CR defined as disappearance of all target lesions; PR defined as >=30% decrease in the sum of the longest diameter of target lesions; SD does not qualify for CR, PR or Progression. All target lesions must be assessed. SD can follow PR only in the rare case that the sum increases by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds. A Clopper-Pearson exact 95% CI for the clinical benefit rate is presented in the below table.|16 weeks from Cycle 1 Day 1|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.|||Percentage of participants||95% Confidence Interval|Number
2678696|NCT01420081|Primary|Clinical Benefit Response for PF-04691502|"Clinical benefit response was defined as best overall response of complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks from Cycle 1 Day 1 (C1D1) to the first time of disease progression. The outcome data table below presents the number of participants with clinical benefit response as yes or no. On 09 Oct 2012, Pfizer decided to stop enrollment into PF-04691502. While tumor assessment for PF-04691502 was included as a listing in the final report, formal efficacy analysis for PF-04691502 was not performed."|16 weeks from Cycle 1 Day 1|Per protocol dataset included participants enrolled for treatment, with baseline tumor, measurable disease and with disease under study. The LIC reporting arm were not a part of the per protocol analysis set for summarizing response.|||Participants|||Number
2678704|NCT01420068|Primary|Change in Weight Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the Enrolled to Follow-up Set (EFS)|Participant weight was measured at Baseline (Visit 2 of the Core study), LT Visit 17, LT Visit 18 ([Week 104] only for participants identified in the core study as having primary hypertension), and LT Visit 19 ([Week 156] only for participants identified in the core study as having secondary hypertension). Body weight was measured to the nearest 0.1 kg in indoor clothing, but without shoes.|Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)|The EFS consisted of all participants who signed the informed consent form (ICF) for the second extension study. Number of participants is the number of EFS participants with non-missing measurement at LT Visit 18. Participants with missing data at LT Visit 18 were not included in the analysis.|||kg||Standard Error|Least Squares Mean
2681451|NCT01392326|Secondary|Percent of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline||Week 24|Full Analysis set|||% participants|||Number
2678697|NCT01420068|Secondary|Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group|All participants who were determined to have secondary hypertension in the core study and had a Baseline (Visit 2) standardized neurocognitive assessment in the core study received follow-up neurocognitive assessments at LT Visit 18 and LT Visit 19 with the same tool. The neurocognitive assessment of development included assessment of the following abilities: Attention, Processing speed, Working memory, and Motor speed. For Numbers (Forward and Backward Raw Score), Visual Matching (Number Correct), Sequences (Total Raw Score): positive change indicates a numerical increase, which is considered a better outcome/improvement; negative change/numerical decrease is considered a worse outcome/decline. For Visual Matching (Time to Complete), Time Tapping (Right and Left Hands), and Timed Gait: positive change indicates a numerical increase, which is considered a worse outcome/decline; negative change/numerical decrease is considered a better outcome/improvement.|Baseline to EOS (3 years). EOS was defined as LT Visit 19 (Week 156) for participants with secondary hypertension.|The EFS consisted of all participants who signed the ICF for the second extension study. Number of participants is those with secondary hypertension and both baseline and LT Visit 19 observations for that test.|||Participants|||Count of Participants
2678698|NCT01420068|Secondary|Change in BMI Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group|Participant weight and height was measured at Baseline (Visit 2 of the Core study), LT Visit 17, LT Visit 18 ([Week 104] only for participants identified in the core study as having primary hypertension), and LT Visit 19 ([Week 156] only for participants identified in the core study as having secondary hypertension). Body weight was measured to the nearest 0.1 kg in indoor clothing, but without shoes. BMI was derived.|Baseline to EOS (2 to 3 years). EOS was defined as LT Visit 18 (Week 104) and LT Visit 19 (Week 156) for participants with primary and secondary hypertension, respectively.|The EFS consisted of all participants who signed the ICF for the second extension study. Number of participants is the number of EFS participants with non-missing measurement at EOS. EOS was defined as LT Visit 18 (Week 104) and LT Visit 19 (Week 156) for participants with primary and secondary hypertension, respectively.|||kg/m^2||Standard Error|Least Squares Mean
2678699|NCT01420068|Secondary|Change in Height Assessments From Baseline (Visit 2 of the Core Study) to EOS by Hypertension Group|Participant height was measured at Baseline (Visit 2 of the Core study), LT Visit 17, LT Visit 18 ([Week 104] only for participants identified in the core study as having primary hypertension), and LT Visit 19 ([Week 156] only for participants identified in the core study as having secondary hypertension).|Baseline to EOS (2 to 3 years). EOS was defined as LT Visit 18 (Week 104) and LT Visit 19 (Week 156) for participants with primary and secondary hypertension, respectively.|The EFS consisted of all participants who signed the ICF for the second extension study. Number of participants is the number of EFS participants with non-missing measurement at EOS. EOS was defined as LT Visit 18 (Week 104) and LT Visit 19 (Week 156) for participants with primary and secondary hypertension, respectively.|||cm||Standard Error|Least Squares Mean
2678700|NCT01420068|Secondary|Change in Weight Assessments From Baseline (Visit 2 of the Core Study) to End of Study (EOS) by Hypertension Group|Participant weight was measured at Baseline (Visit 2 of the Core study), LT Visit 17, LT Visit 18 ([Week 104] only for participants identified in the core study as having primary hypertension), and LT Visit 19 ([Week 156] only for participants identified in the core study as having secondary hypertension). Body weight was measured to the nearest 0.1 kg in indoor clothing, but without shoes.|Baseline to EOS (2 to 3 years). EOS was defined as LT Visit 18 (Week 104) and LT Visit 19 (Week 156) for participants with primary and secondary hypertension, respectively.|The EFS consisted of all participants who signed the ICF for the second extension study. Number of participants is the number of EFS participants with non-missing measurement at EOS. EOS was defined as LT Visit 18 (Week 104) and LT Visit 19 (Week 156) for participants with primary and secondary hypertension, respectively.|||kg||Standard Error|Least Squares Mean
2678701|NCT01420068|Primary|Change in Neurocognitive Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS|All participants who were determined to have secondary hypertension in the core study and had a Baseline (Visit 2) standardized neurocognitive assessment in the core study received follow-up neurocognitive assessments at LT Visit 18 and LT Visit 19 with the same tool. The neurocognitive assessment of development included assessment of the following abilities: Attention, Processing speed, Working memory, and Motor speed. For Numbers (Forward and Backward Raw Score), Visual Matching (Number Correct), Sequences (Total Raw Score): positive change indicates a numerical increase, which is considered a better outcome/improvement; negative change/numerical decrease is considered a worse outcome/decline. For Visual Matching (Time to Complete), Time Tapping (Right and Left Hands), and Timed Gait: positive change indicates a numerical increase, which is considered a worse outcome/decline; negative change/numerical decrease is considered a better outcome/improvement.|Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)|The EFS consisted of all participants who signed the ICF for the second extension study. Number of participants is those with secondary hypertension and both baseline and LT Visit 18 observations for that test.|||Participants|||Count of Participants
2678702|NCT01420068|Primary|Change in BMI Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS|Participant height and weight was measured at Baseline (Visit 2 of the Core study), LT Visit 17, LT Visit 18 ([Week 104] only for participants identified in the core study as having primary hypertension), and LT Visit 19 ([Week 156] only for participants identified in the core study as having secondary hypertension). BMI was derived.|Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)|The EFS consisted of all participants who signed the ICF for the second extension study. Number of participants is the number of EFS participants with non-missing measurement at LT Visit 18. Participants with missing data at LT Visit 18 were not included in the analysis.|||kg/m^2||Standard Error|Least Squares Mean
2678703|NCT01420068|Primary|Change in Height Assessments From Baseline (Visit 2 of the Core Study) to Long Term (LT) Visit 18 (Week 104) for the EFS|Participant height was measured at Baseline (Visit 2 of the Core study), LT Visit 17, LT Visit 18 ([Week 104] only for participants identified in the core study as having primary hypertension), and LT Visit 19 ([Week 156] only for participants identified in the core study as having secondary hypertension).|Baseline to LT Visit 18 (Week 104): 2 years (104 weeks)|The EFS consisted of all participants who signed the ICF for the second extension study. Number of participants is the number of EFS participants with non-missing measurement at LT Visit 18. Participants with missing data at LT Visit 18 were not included in the analysis.|||cm||Standard Error|Least Squares Mean
2678705|NCT01420016|Primary|Predicted Annual Rate of Change in 10-year Risk of Fatal or Nonfatal Heart Attack or Stroke|Ten year cardiovascular risk was calculated at each post index visit from the most recent clinical and laboratory values in the EMR. The Framingham lipid equation was used when a lipid value was available in the previous 5 years; otherwise the Framingham BMI equation was used. The primary outcome was the annualized rate of change (slope) in 10-year CVR, estimated for each treatment group from the time and time-by-treatment parameters of a mixed regression model which predicted post-index CVR values from time elapsed since index, treatment group and the time by treatment interaction.|Index to 14 months post index|The patients whose data were included in the primary outcomes analyses met each of the following eligibility criteria. Each patient had an index visit; their first post-implementation primary care visit in a randomized clinic at which they were eligible for the CV Wizard intervention. Visits were intervention eligible based on the CDS algorithms.|||annualized change in 10 year % cv risk||95% Confidence Interval|Number
2678706|NCT01419977|Primary|Change in Clinical Pain Scores|"The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with 0 corresponding to no pain at one end and 10 indicating the worst pain at the other."|Baseline to day 3|9 subjects were discharged prior to obtaining day 3 VAS score.|||units on a scale||Standard Deviation|Mean
2678707|NCT01419977|Primary|Change in Thrombin Generation Assay - Endogenous Thrombin Potential|Patients will have thrombin generation assay samples drawn on Day 1 and 3|Day 1 and Day 3|9 subjects were discharged prior to day 3 so the day 3 blood sample was not obtained.|||nM||Standard Deviation|Mean
2678708|NCT01419977|Primary|Change in Clinical Pain Scores|"The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with 0 corresponding to no pain at one end and 10 indicating the worst pain at the other."|Baseline to day 1||||units on a scale||Standard Deviation|Mean
2678709|NCT01419977|Primary|Change in D-dimer|Patients will have D-dimer,for samples drawn on Day 1 and Day 3|Day 1 and Day 3|9 subjects were discharged prior to day 3 so the day 3 blood sample was not obtained.|||ng/mL||Standard Deviation|Mean
2678710|NCT01419795|Secondary|Donor and Host Polymorphisms of the FCgamma RIIIa Receptor and Their Impact on Disease Response and Relapse||Baseline, day 7 and 28 of course 1, and day 28 of course 3|With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected.||||||
2678711|NCT01419795|Secondary|Pharmacokinetics of Rituximab: Evaluation of Serum Concentrations and Correlations to Drug Dose and Clinical Responses||Baseline, day 7 and 28 of course 1, and day 28 of course 3|With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected.||||||
2678712|NCT01419795|Secondary|Comparison of Incidences of Adverse Events Between the First, Second, and Third Cohorts||Assessed up to 30 days after completion of study treatment|No participants enrolled in the second arm. Not enough participants in first arm to make meaningful comparisons to historic controls.|||Number of adverse events|||Number
2678713|NCT01419795|Secondary|Changes in Plasma Cytokines and Peripheral Blood Lymphocytes in Correlation to Treatment With Lenalidomide||From baseline to day 28 of course 3|With only 3 participants enrolled to the first arm, meaningful comparisons could not be made and data for this objective was not collected.||||||
2678714|NCT01419795|Secondary|Comparison of Rates of Overall Response and Complete Remission Between the First, Second, and Third Cohorts||Assessed up to 18 months|No participants enrolled in the second arm. Not enough participants in first arm to make meaningful comparisons to historic controls.|||Participants|||Count of Participants
2678715|NCT01419795|Secondary|Incidences of Grades II-IV Acute GVHD and Limited or Extensive Chronic GVHD||Assessed up to 30 days after completion of study treatment|No participants enrolled in the second arm.|||Participants|||Count of Participants
2678716|NCT01419795|Secondary|Grade III-IV Toxicity in Patients Receiving Lenalidomide With or Without Rituximab||Assessed up to 30 days after completion of study treatment|No participants enrolled in the second arm.|||Participants|||Count of Participants
2678717|NCT01419795|Secondary|Rate of Response (CR, PR, or SD) and Time to Progression|Estimated using the Kaplan-Meier method in all cohorts. Assessed at day 100.|Assessed up to 18 months|No participants enrolled in the second arm.|||progression free survival probability||95% Confidence Interval|Number
2678718|NCT01419795|Primary|Improvement in Overall Survival of Patients Receiving Lenalidomide With or Without Rituximab in Comparison to Historical Controls Managed by Single or Multiple Chemotherapeutic Agents or Donor Lymphocyte Infusion (DLI) (Cohort 1)|Estimated using the Kaplan-Meier method in all cohorts.|12 months|Primary objective could not be completed because there were no patients enrolled in the second experimental arm (lenalidomide). Additionally, having only three patients in one arm does not allow for a meaningful comparison to historic controls.|||survival probability||95% Confidence Interval|Number
2678719|NCT01419769|Primary|Safety - Freedom From Major Complications: SAE's|Treated subjects are free of serious adverse event classified as implant-associated or implant/endoscopic procedure-associated.|Through the duration of the 1-week post-stent removal study period|Intent-to-Treat population|||percentage of patients|||Number
2678720|NCT01419769|Primary|Safety - Freedom From Major Complications: Tissue Injury|Subjects are free of tissue injury (ulceration to the submucosa) at stent site persisting through 1-week post-stent removal.|Through the duration of the 1-week post-stent removal study period|Per protocol population|||percentage of patients|||Number
2678721|NCT01419769|Primary|Safety - Freedom From Major Complications: Stent Migration/Dislodement|Treated subjects are free of stent migration/ dislodgement into the pseudocyst or enteral lumen|Through the duration of the 1-week post-stent removal study period|Per protocol population of subjects with stent successfully placed|||percentage of patients|||Number
2678722|NCT01419769|Primary|Safety - Freedom From Major Complications: Perforation|Subjects are free of surgery for access-site related perforation|Through the duration of the 1-week post-stent removal study period|Intent-to-Treat population|||percentage of patients|||Number
2678723|NCT01419769|Primary|Safety - Freedom From Major Complications: Access Site-related Infection|Subjects are free of access site-related infection requiring intravenous or intramuscular antibiotics and/or extended hospitalization|Through the duration of the 1-week post-stent removal study period|Per protocol population|||percentage of patients|||Number
2680324|NCT01402102|Secondary|Changes in FFA(Free Fatty Acid)|FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||µEq/L||Standard Deviation|Mean
2678726|NCT01419769|Secondary|Effectiveness: Stent Removability at 30 Days and/or 60 Days|AXIOS stent removal was indicated at the time of pseudocyst resolution (≤ 3 cm diameter) or at 60 the day post procedure visit. Scheduled examination for pseudocyst resolution was designated at 30 days for removal if the pseudocyst resolution criterion was met. Otherwise, the stent was left in place for removal at the 60 day visit.|Up to 60 days|Patients who had AXIOS stent successfully placed during index procedure.|||percentage of patients|||Number
2678727|NCT01419769|Secondary|Effectiveness: Stent Lumen Patency at 30 Days and/or 60 Days|Stent lumen patency at 30 days and/or 60 days.|Up to 60 days|Patients treated per protocol with successful stent placement.|||percentage of patients|||Number
2678728|NCT01419769|Primary|Safety - Freedom From Major Complications: Access Site-related Bleeding|Subjects are free of access site-related bleeding requiring transfusion|Through the duration of the 1-week post-stent removal study period|Intent-to-Treat population|||percentage of patients|||Number
2678729|NCT01419717|Secondary|Number of Participants With Anti-denosumab Binding Antibodies|A blood sample was collected at the end of study visit for the measurement of anti-denosumab binding antibodies.|Assessed at end of study; the median (minimum, maximum) time on study for all enrolled participants was 13.9 (0.0, 74.7) months.|Participants who received at least 1 dose of denosumab in study 20110113 and with at least 1 antibody sample tested.|||Participants|||Count of Participants
2678730|NCT01419717|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment.~Each AE was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE. Treatment-related adverse events (TRAEs) includes events for which the investigator indicated there was a reasonable possibility they may have been caused by investigational product."|From first dose of denosumab in Study 20110113 to end of study; median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.|All participants who received at least one dose of denosumab in study 20110113|||Participants|||Count of Participants
2678731|NCT01419639|Primary|Change in Tumor Size From Baseline||1 Year||||% of change in tumor size from baseline|Tumors|Full Range|Median
2678732|NCT01419639|Secondary|Audiologic Response|"Defined as improvement in speech discrimination score (SDS), defined as an improvement in the score above the 95% critical difference threshold, compared to baseline audiogram at initiation of treatment. Audiologic worsening: decrease in SDS score below the 95% critical difference threshold, compared to baseline audiogram at initiation of treatment.~Patients with vestibular schwannomas will receive baseline audiograms within 28 days before enrollments and subsequent audiograms at the time of each MRI."|1 Year||||participants|||Number
2678733|NCT01419639|Primary|Radiographic Response|To estimate the objective response rates to RAD001 in patients with NF2-related tumors including cranial nerve schwannomas, meningiomas and ependymomas. Radiographic response for study purposes = greater than or equal to 15% reduction in tumor volume in any of the target tumors (partial response). Complete disappearance of any of the target tumors = complete response. MRI of the brain and spine will be performed every 3 months. If an objective response (15% reduction in tumor volume compared to baseline) is observed in any target tumor or stable disease, drug will be continued.|1 Year||||participants|Tumors||Number
2678734|NCT01419626|Secondary|Whole-mouth Mean Bleeding Index (Mean BI) at Week 2 and 4|Bleeding was assessed using the Gingival BI. A periodontal probe with a 0.5 millimeter (mm) diameter tip was inserted into the gingival crevice, and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of four gingival areas (distobuccal, midbuccal, mid-lingual, and mesiolingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0 indicates absence of bleeding after 30 seconds; 1 indicates bleeding after 30 seconds; 2 indicates immediate bleeding.|Week 2 and 4|FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline.|||Units on a scale||Standard Error|Least Squares Mean
2678735|NCT01419626|Secondary|Interproximal Mean Bleeding Index (Mean BI) at Week 2 and 4|Bleeding was assessed using the Gingival BI. A periodontal probe with a 0.5 millimeter (mm) diameter tip was inserted into the gingival crevice, and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of four gingival areas (distobuccal, midbuccal, mid-lingual, and mesiolingual) around each tooth was assessed. After approximately 30 seconds, bleeding at each gingival unit was recorded according to the following scale: 0 indicates absence of bleeding after 30 seconds; 1 indicates bleeding after 30 seconds; 2 indicates immediate bleeding.|Week 2 and 4|FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline.|||Units on a scale||Standard Error|Least Squares Mean
2678736|NCT01419626|Secondary|Whole-mouth Mean Plaque Index (Mean PI) at Week 2|Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 mm), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.|Week 2|FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline.|||Units on a scale||Standard Error|Least Squares Mean
2678737|NCT01419626|Secondary|Interproximal Mean Plaque Index (Mean PI) at Week 2|Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 mm), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.|Week 2|FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline.|||Units on a scale||Standard Error|Least Squares Mean
2678738|NCT01419626|Secondary|Whole-mouth Modified Gingival Index (Mean MGI) at Week 2 and 4|Gingivitis was assessed by the MGI on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth as per following score range: 0 indicates normal (absence of inflammation;) 1 indicates mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2 indicates mild inflammation of the entire gingival unit; 3 indicates moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit. 4 indicates severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.|Week 2 and 4|FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline.|||Units on a scale||Standard Error|Least Squares Mean
2678739|NCT01419626|Secondary|Interproximal Mean Modified Gingival Index (Mean MGI) at Week 2 and 4|Gingivitis was assessed by the MGI on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth as per following score range: 0 indicates normal (absence of inflammation;) 1 indicates mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2 indicates mild inflammation of the entire gingival unit; 3 indicates moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit. 4 indicates severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.|Week 2 and 4|FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline.|||Units on a scale||Standard Error|Least Squares Mean
2678740|NCT01419626|Primary|Whole-mouth Mean Plaque Index at Week 4|Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 mm), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.|Week 4|FAS included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline.|||Units on a scale||Standard Error|Least Squares Mean
2678741|NCT01419626|Primary|Interproximal Mean Plaque Index at Week 4|Plaque area was scored using the Turesky modification of the Quigley-Hein Plaque Index (PI), on six surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, using following score range; 0: indicates no plaque; 1: separate flecks or discontinuous band of plaque on the gingival (cervical) margin; 2: thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin; 3: band of plaque wider than 1mm but less than1/3 of the surface; 4: plaque covering 1/3 or more, but less than 2/3 of the surface; 5 plaque covering 2/3 or more of the surface.|Week 4|Full analysis set (FAS) included all randomized participants who used study product and had baseline and at least one data for mean PI post baseline.|||Units on a scale||Standard Error|Least Squares Mean
2678742|NCT01419314|Secondary|Function-Walking Distance|"Six minute walk test~For this test the participants were instructed to: Please walk as far, as fast and as safe as you can for up to six minutes. The walking test will be performed in a climate-controlled environment, on a level surface void of obstacles and with a pre-determined path of 68 feet (or approximately 20 m) per lap. The beginning and end of the 34-foot path were clearly marked with taped trapezoids to the non-skid floor."|week 6|The number of participants returning for the 6 week follow-up|||Meters (m)||Standard Deviation|Mean
2678743|NCT01419314|Secondary|Function-Walking Distance|"Six minute walk test~For this test the participants were instructed to: Please walk as far, as fast and as safe as you can for up to six minutes. The walking test will be performed in a climate-controlled environment, on a level surface void of obstacles and with a pre-determined path of 68 feet (or approximately 20 m) per lap. The beginning and end of the 34-foot path were clearly marked with taped trapezoids to the non-skid floor."|week 3|The number of participants returning for the 3 week follow-up with complete data|||Meters (m)||Standard Deviation|Mean
2678744|NCT01419314|Primary|Sleep Quality/Quantity Scores (PSQI)|The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions. Buysse et al. reported sensitivity and specificity values of 89.6% and 86.5%, respectively for this scale in identifying good and poor sleepers.|week 6|The number of participants returning for the second follow-up|||Scores ranging 0-21, 0=no disturbances||Standard Deviation|Mean
2678745|NCT01419314|Primary|Sleep Quality/Quantity Scores (PSQI)|The Pittsburgh Sleep Quality Index (PSQI) is a ten item questionnaire, covering the following seven components of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunctions.|week 3|The number of participants returning for the first follow-up with complete data.|||Scores ranging 0-21, 0=no disturbances||Standard Deviation|Mean
2678746|NCT01419314|Secondary|Function-Reach|"Forward reach test~For this test, the investigators asked the participants to stand next to a wall without shoes and with their feet positioned hip-width apart on the floor with one shoulder close to the wall. The participants were instructed to reach as far forward as possible, without losing your balance, touching the wall or stepping and crossing the tile threshold on the floor. The average distance of three reaching attempts was recorded and used in the analysis."|week 6|The number of participants returning for the first follow-up. One participant in the liner group had baseline scores greater than 3 standard deviation difference from the mean and was excluded from the analysis.|||Centimeters (cm)||Standard Deviation|Mean
2678747|NCT01419314|Secondary|Function-Reach|"Forward reach test~For this test, the investigators asked the participants to stand next to a wall without shoes and with their feet positioned hip-width apart on the floor with one shoulder close to the wall. The participants were instructed to reach as far forward as possible, without losing your balance, touching the wall or stepping and crossing the tile threshold on the floor. The average distance of three reaching attempts was recorded and used in the analysis."|week 3|The number of participants returning for the first follow-up. One participant in the liner group had baseline scores greater than 3 standard deviation difference from the mean and was excluded from the analysis.|||Centimeters (cm)||Standard Deviation|Mean
2681452|NCT01392326|Secondary|Percent of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Baseline||Week 24|Full analysis set|||% participants|||Number
2678749|NCT01419314|Primary|Pain Scores at Week 3|A composite pain score was collected using the self-reported Neuropathic Pain Scale (NPS). In this zero to 100 scale, the participant is asked to quantify the different aspects of the pain experience in the presence of neuropathies.|Week 3|The total number of participants returning for the first follow-up at week three with complete data.|||units on a scale 0-100 (0= no pain)||Standard Deviation|Mean
2678750|NCT01419275|Primary|Percentage of Regions With Collateral Versus Antegrade Blood Flow (Sensitivity) Correctly Identified Using MRI With Xenon Contrast Agent (Specificity)|Sensitivity and specificity for MRI-based ASL measure of presence of collaterals was measured using digital subtraction angiography as a gold standard. Measurements were for 20 regions per patient were scored as either positive or negative for collateral flow. A positive value (results) means the region is supplied by collateral flow. Negative means the region is supplied by antegrade (normal) flow. Sensitivity measures the proportion of positives that are correctly identified as such. Specificity measures the proportion of negatives that are correctly identified as such.|performed one time within 1 week prior to surgery|One participant did not undergo MRI and was not included in the analysis.|||percentage of regions|Cerebral regions|95% Confidence Interval|Number
2678751|NCT01419249|Primary|Height Velocity Standard Deviation Score (SDS) at Year 1|Height velocity SDS was calculated as height velocity minus reference mean height velocity divided by standard deviation of the reference population. Height velocity SDS reflects the height velocity relative to a reference population of the same age and gender. Height velocity SDS at Year 1 was one of the growth parameter to assess the first year growth response to r-hGH treatment.|Year 1|FAS population included all the participants who had provided informed consent and had non-missing height at start (defined as within one month prior to treatment start date) and at 1 year (+/- 120 days) of r-hGH treatment and had pharmacogenomics data available.|||standard deviation score||Standard Deviation|Mean
2678752|NCT01419249|Primary|Change From Baseline in Height Standard Deviation Score (SDS) at Year 1|Height SDS was calculated as height minus reference mean height divided by standard deviation of the reference population. Height SDS reflects the height relative to a reference population of the same age and gender. Change from baseline in height SDS at Year 1 was one of the growth parameter to assess the first year growth response to r-hGH treatment.|Baseline and Year 1|FAS population included all the participants who had provided informed consent and had non-missing height at start (defined as within one month prior to treatment start date) and at 1 year (+/- 120 days) of r-hGH treatment and had pharmacogenomics data available.|||standard deviation score||Standard Deviation|Mean
2678753|NCT01419249|Secondary|Evaluation of the Contribution of Validated Genetic Markers to the Amplitude of First Year Growth Response to r-hGH Therapy in TS Girls Using Turner Syndrome Kabi-Pharmacia International Growth Study (TS KIGS) Predictive Model|TS KIGS predictive model includes various clinical, auxological and biological markers which are as follows: maximum GH response to provocation test; age at onset of therapy; birth weight SDS; average GH dose received during the first year of r-hGH therapy; height SDS at start of therapy; the difference between the pre-treatment height SDS of the subject and the mid parental height SDS; and weight SDS at start of therapy.|Year 1|No genetic markers were identified during the study therefore, the data for this outcome measure was not analyzed.||||||
2678754|NCT01419249|Secondary|Evaluation of the Contribution of Validated Genetic Markers to the Amplitude of First Year Growth Response to r-hGH Therapy in IGHD Children Using Growth Hormone Deficiency Kabi-Pharmacia International Growth Study (GHD KIGS) Predictive Model|GHD KIGS predictive model includes various clinical, auxological and biological markers which are as follows: maximum growth hormone (GH) response to provocation test; age at onset of therapy; birth weight SDS; average GH dose received during the first year of r-hGH therapy; height SDS at start of therapy; the difference between the pre-treatment height SDS of the subject and the mid parental height SDS; and weight SDS at start of therapy.|Year 1|No genetic markers were identified during the study therefore, the data for this outcome measure was not analyzed.||||||
2678755|NCT01419249|Primary|Change From Baseline in Height at Year 1|Change from baseline in height at year 1 was one of the growth parameter to assess the first year growth response to r-hGH treatment.|Baseline and Year 1|FAS population included all the participants who had provided informed consent and had non-missing height at start (defined as within one month prior to treatment start date) and at 1 year (+/- 120 days) of r-hGH treatment and had pharmacogenomics data available.|||centimeter||Standard Deviation|Mean
2678756|NCT01419236|Secondary|Change From Baseline in MSHQ-EjD-SF Bother/Satisfaction Score at 16 Weeks|"The MSHQ-EjD-SF was a 4 item, self-reported questionnaire used for the assessment of EjD during the past month. The MSHQ-EjD-SF Bother/Satisfaction Score was based on Q4: If you have had any ejaculation difficulties or have been unable to ejaculate, have you been bothered by this? Scores ranged from 0 (no problem with ejaculation), 1 (not at all bothered) to 5 (extremely bothered). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline Bother/Satisfaction Score as fixed effects, and unstructured covariance structure for modeling correlation."|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.|||units on a scale||Standard Error|Least Squares Mean
2678757|NCT01419236|Secondary|Change From Baseline in the International Index of Erectile Function (IIEF)-Orgasmic Function Domain Score at 16 Weeks|IIEF: 15 item, self-reported questionnaire assessing overall erectile function and satisfaction during past month. Orgasmic Function Domain Score: sum of IIEF scores for Q9 and Q10. In Q9, participants (pts) identified how often they ejaculated when having sexual stimulation or intercourse. In Q10, pts identified how often they had a feeling of an orgasm with or without ejaculation when having sexual stimulation or intercourse. For each Q, scores ranged from 0 (no sexual stimulation or intercourse), 1 (almost never or never) to 5 (almost always or always). Total Orgasmic Function Domain Scores ranged from 0 to 10. LS mean of change from baseline calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline Orgasmic Function Domain Score as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.|||units on a scale||Standard Error|Least Squares Mean
2678758|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Orgasmic Pleasure at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Reported is orgasmic pleasure rated from 0 (no pleasure) to 10 (excellent). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline orgasmic pleasure as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.|||units on a scale||Standard Error|Least Squares Mean
2678759|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Frequency of Sexual Attempts at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the change from baseline number of sexual attempts at 16 weeks. LS mean of change from baseline was calculated using an analysis of covariance (ANCOVA) including treatment group, region, baseline total testosterone level, baseline ED severity (normal, mild, moderate, severe) as fixed effects, and centered baseline as a covariate.|Baseline, up to 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline; Last observation carried forward (LOCF).|||sexual attempts||Standard Error|Least Squares Mean
2678760|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Delayed Ejaculation at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is delayed ejaculation rated from 0 (did not ejaculate) to 10 (optimal/best ejaculate time). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline delayed ejaculation as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.|||units on a scale||Standard Error|Least Squares Mean
2678761|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Perceived Force of Ejaculation at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the perceived force of ejaculation rated from 0 (could not ejaculate) to 10 (strong ejaculation). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline perceived force of ejaculation as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.|||units on a scale||Standard Error|Least Squares Mean
2678762|NCT01419236|Secondary|Change From Baseline in Sexual Activity Log: Perceived Volume of Ejaculate at 16 Weeks|The sexual activity log was used by study participants to document ejaculatory functioning and orgasmic pleasure for each sexual activity attempt over 4 weeks. Ejaculatory functioning included perceived volume of ejaculate, perceived force of ejaculation, delayed ejaculation, and frequency. Reported is the perceived volume of ejaculate rated from 0 (no ejaculate) to 10 (high volume of ejaculate). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline ejaculatory volume as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.|||units on a scale||Standard Error|Least Squares Mean
2678763|NCT01419236|Secondary|Change From Baseline in Ejaculate Volume at 16 Weeks|The change from baseline in ejaculate volume was determined by actual measurement of semen volume in milliliters (mL). LS mean of change from baseline was calculated using MMRM including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level (≥200 ng/dL vs. <200 ng/dL), baseline ED severity (normal, mild, moderate, severe), and centered baseline ejaculatory volume as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.|||mL||Standard Error|Least Squares Mean
2678764|NCT01419236|Primary|Change From Baseline in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Ejaculatory Function Score at 16 Weeks|MSHQ-EjD-SF: 4 item, self-reported questionnaire assessing ejaculatory dysfunction. MSHQ-EjD-SF Ejaculatory Function Score: sum of scores for questions (Q)1 through Q3 about frequency and strength of ejaculations and volume of ejaculate for sexual activity attempts during past month. Ejaculation frequency was rated 1 (could not ejaculate) to 5 (all the time); strength and volume from 0 (could not ejaculate) to 5 (as strong/much as it always has been). Total Ejaculatory Function Score ranged from 1 to 15. Least-squares (LS) mean of change from baseline calculated using repeated measures mixed‐effects model (MMRM) including treatment, visit, treatment-by-visit interaction, region, baseline total testosterone level [≥200 nanograms per deciliter (ng/dL) versus (vs.) <200 ng/dL], baseline erectile dysfunction (ED) severity (normal, mild, moderate, severe), and centered baseline ejaculatory function score as fixed effects, and unstructured covariance structure for modeling correlation.|Baseline, 16 weeks|Randomized participants who received at least 1 dose of study drug and completed the MSHQ-EjD-SF questionnaire at least once post-baseline.|||units on a scale||Standard Error|Least Squares Mean
2678800|NCT01418937|Primary|Number of Subjects With Potential Immune-mediated Disease (pIMDs)||Throughout the study period (from Month 0 up to Month 12)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered|||Subjects|||Number
2678765|NCT01419197|Secondary|6-month and 1-year Survival (Final Analysis)|6-month and 1-year survival were defined as the percentage of participants who were alive at 6 months and 1 year, respectively, as estimated using Kaplan-Meier method.|Baseline to the clinical cut-off date of 13 Feb 2015 (up to 4 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2678766|NCT01419197|Secondary|Overall Survival (Final Analysis)|Overall survival was defined as the time from randomization to death from any cause.|Baseline to the clinical cut-off date of 13 Feb 2015 (up to 4 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2678767|NCT01419197|Secondary|Change From Baseline in the EORTC QLQ-BM22 Pain Score on Day 1 of Each Cycle|The EORTC QLQ-BM22 assesses the symptoms of bone metastases using 22 items: 5 items for sites of pain, 3 pain characteristics, 8 functional interference aspects, and 6 psychosocial aspects. The pain score was derived from the 3 pain characteristic items. Each item was rated on a 4-point scale, where 1=Not at all to 4=Very much. The pain score was the sum of the 3 pain characteristic scores and was normalized to a scale of 0 to 100. A higher score indicates greater pain. A negative change score indicates improvement.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Only participants with a Baseline pain score and at least 1 post-baseline pain score were included in the analysis. Participants were included in the treatment group to which they were randomized.|||Units on a scale||Standard Deviation|Mean
2678768|NCT01419197|Secondary|Time to Pain Symptom Progression|Time to pain symptom progression was defined as the time from randomization to the first documentation of an increase in narcotic use and/or a 10 point increase from Baseline in the pain score as measured by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire for patients with bone metastases (EORTC QLQ-BM22). The EORTC QLQ-BM22 assesses the symptoms of bone metastases using 22 items: 5 items for sites of pain, 3 pain characteristics, 8 functional interference aspects, and 6 psychosocial aspects. The pain score was derived from the 3 pain characteristic items. Each item was rated on a 4-point scale, where 1=Not at all to 4=Very much. The pain score was the sum of the 3 pain characteristic scores and was normalized to a scale of 0 to 100. A higher score indicates greater pain.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Only participants with a Baseline pain score and at least 1 post-baseline pain score were included in the analysis. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2678769|NCT01419197|Secondary|6-month and 1-year Survival|6-month and 1-year survival were defined as the percentage of participants who were alive at 6 months and 1 year, respectively, as estimated using Kaplan-Meier method.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2678770|NCT01419197|Secondary|Duration of the Objective Response|Duration of the objective response was defined as the time from the first tumor assessment that was judged to indicate that the patient had an objective response to the time of first documented disease progression using RECIST v1.1 per investigator assessment or death from any cause, whichever occurred first.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Only participants with an objective response were included in the analysis. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2678771|NCT01419197|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum. Participants who had no post-baseline tumor assessment were counted as non-responders.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Only participants with measurable disease at Baseline were included in the analysis. Participants were included in the treatment group to which they were randomized.|||Percentage of participants||95% Confidence Interval|Number
2678772|NCT01419197|Primary|Overall Survival|Overall survival (OS) was defined as the time from randomization to death from any cause. Overall survival was a co-primary endpoint.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2678773|NCT01419197|Primary|Progression-free Survival|Progression-free survival was defined as the time from randomization to the first documented disease progression by investigator assessment using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurred first. Progression-free survival was a co-primary endpoint.|Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)|Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.|||Months||95% Confidence Interval|Median
2678774|NCT01419184|Secondary|cSSSI-related Medical Resource Utilization and Costs|Direct medical costs were based on utilization of health resources. Unit cost data were obtained from sources external to the trial and assigned to corresponding medical resource utilization observed within the trial to estimate costs of care. cSSSI-related costs were reported from a societal perspective, and further broken down into a health care system perspective. The health care system perspective includes hospital and outpatient costs. The societal perspective includes the health care system perspective plus participant and caregiver time loss from work and participant and caregiver out-of-pocket expenses. Total cost (including both total inpatient and total post-discharge costs) per participant is presented.|Baseline (Day 0) through 30 days post hospital discharge|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS.|||dollars (United States)||Standard Deviation|Mean
2678775|NCT01419184|Secondary|30-day cSSSI-related Hospital Readmission Rates|Hospital readmission rates were defined as readmission to an inpatient hospital facility within 30 days of hospital discharge for management of cSSSI relapse or treatment of adverse events related to cSSSI treatment. It did not include all-cause readmissions (for completeness, all-cause readmissions are reported in the descriptive tables). Participants were asked if they had been readmitted to the hospital since their discharge and whether the admission was specifically for their skin infection. The number of participants who were re-hospitalized for skin infection or side effects due to skin infection medication within 30 days since the initial hospital discharge (Day 14) is presented.|End of Hospital Stay (up to Day 14) through 30 days post hospital discharge|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS.|||participants|||Number
2678776|NCT01419184|Secondary|Participant Global Impression of Improvement (PGI-I) at Hospital Discharge|PGI-I assessments of improvement were measured by asking participants: How is your skin infection today compared to how it was yesterday? Scores were calculated based on response to the single item, where 1 = improved a lot; 2 = improved moderately; 3 = improved a little; 4 = no change; 5 = worsened a little; 6 = worsened moderately; 7 = worsened a lot. Mean PGI-I scores are presented at hospital discharge; lower values represent greater improvement.|End of Hospital Stay (up to Day 14)|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. Participants also had evaluable PGI-I data at hospital discharge.|||units on a scale||Standard Deviation|Mean
2678777|NCT01419184|Secondary|Mean Change From Baseline to Hospital Discharge in Participant-reported Health-related Quality of Life (HRQoL)|Health-related quality of life (HRQoL) was measured using the EuroQol-5 Dimensions, 5 Level (EQ-5D-5L) multi-attribute questionnaire. The 5 dimensions measured were: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant's health state was expressed by a descriptive profile of a 5 digit number. The EQ-5D health states were converted into a single summary index (from 0 to 1, with 0 representing death, to 1 representing perfect health) by applying weights to each of the levels in each dimension. Change from baseline to hospital discharge is presented; positive values represent an increase in health utility.|Baseline (Day 0), End of Hospital Stay (up to Day 14)|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. Participants also had evaluable EQ-5D data at baseline and at hospital discharge.|||units on a scale||Standard Deviation|Mean
2678778|NCT01419184|Secondary|Mean Change From Baseline to Hospital Discharge in Pain According to the Brief Pain Inventory-Short Form (BPI-SF)|"Pain was measured as the amount of pain experienced right now by the participant using an 11-point numerical rating scale adapted from Brief Pain Inventory-Short Form (BPI-SF). Participants were asked to rate pain in his or her skin infection from 0 to 10, where 0 is no pain and 10 is pain as bad as he or she could imagine. Change from baseline to hospital discharge is presented; a negative value represents a decrease in pain."|Baseline (Day 0), End of Hospital Stay (up to Day 14)|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. Participants also had evaluable BPI-SF data at baseline and at hospital discharge.|||units on a scale||Standard Deviation|Mean
2678779|NCT01419184|Primary|Infection-Related Hospital Length of Stay|Infection Related Hospital Length of Stay (IRLOS) is defined as the number of hours of hospitalization associated with antibiotic treatment of the complicated skin and skin structure infections (cSSSI) beginning at initiation of study-antibiotic administration and ending at discontinuation of all antibiotic therapy for cSSSI or at hospital discharge (whichever occurred first). This included continued hospitalization for treatment of adverse events resulting from use of the study antibiotic or subsequent antimicrobial therapy. The mean number of hours for each treatment group is presented.|Baseline (Day 0) through the End of Hospital Stay (up to Day 14)|The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. As the end of the IRLOS depended upon the participant’s course of treatment, no static set of items were answered to determine if a participant had complete data.|||Hours||Standard Deviation|Mean
2678780|NCT01419171|Secondary|Clinical Procedural Success Rate|Clinical Procedural Success: lesion diameter stenosis < 30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death. Summarized per patient.|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||percentage of patients||95% Confidence Interval|Number
2678781|NCT01419171|Secondary|Periprocedural Endpoints: Technical Success Rate|Technical success: successful delivery and deployment of the study stent to the target vessel, without balloon rupture or embolization. Summarized per attempted study stent.|Participants will be followed for the duration of hospital stay, an expected average of 1 day||||percentage of patients|Participants|95% Confidence Interval|Number
2678782|NCT01419171|Secondary|12 Month Stent Thrombosis Rate (Definite or Probable by Academic Research Consortium [ARC] Definitions)||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
2678783|NCT01419171|Secondary|12 Month All Death/MI/TVR Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
2678784|NCT01419171|Secondary|12 Month All Death or MI Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
2678785|NCT01419171|Secondary|12 Month Cardiac Death or MI Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
2678786|NCT01419171|Secondary|12 Month All Death Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
2678787|NCT01419171|Secondary|12 Month Non-cardiac Death Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
2678788|NCT01419171|Secondary|12 Month Cardiac Death Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
2678789|NCT01419171|Secondary|12 Month Myocardial Infarction (MI)(Q-wave and Non-Q-wave) Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
2678790|NCT01419171|Secondary|12 Month Target Vessel Failure (TVF) Rate|Target vessel failure is any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.|Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
2678791|NCT01419171|Secondary|12 Month Target Vessel Revascularization (TVR) Rate||Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
2678792|NCT01419171|Secondary|12 Month Target Lesion Revascularization (TLR) Rate|Any ischemia-driven repeat percutaneous coronary intervention (PCI), to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.|Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months|12-Month rates: the percentage of patients who experience an event through 365 days post-procedure out of the patients who have either had an event within 365 days post-procedure or who were event-free with last follow-up at least 335 days post-procedure.|||percentage of participants||95% Confidence Interval|Number
2678793|NCT01419171|Primary|9-month Target Lesion Failure (TLF) Rate|The primary endpoint is 9-month target lesion failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), Myocardial Infarction (MI) (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.|Nine Month|N=323 (5 patients were not evaluable for the endpoint: Follow-up < 240 days and event-free)|||percentage of participants||95% Confidence Interval|Number
2678794|NCT01419080|Secondary|All-cause Mortality|all-cause mortality|One Year||||Participants|||Count of Participants
2678795|NCT01419080|Primary|Peripheral Artery Disease (PAD) - Specific Health Status|Scores on a scale of 0-100 with higher scores representing better health status (0= worst health imaginable, 100= best health imaginable). Subscales are weighed in a standardized scoring algorithm (proprietary). Measures symptoms, symptom stability, and quality of life.|One Year||||units on a scale of 0-100||Standard Deviation|Mean
2678796|NCT01419028|Secondary|Invasive Ventilator-free Survival Time|Invasive ventilator-free survival is defined as the time during which the patient is alive and not invasively ventilated. For the purpose of this study, invasive ventilation is defined as mechanical ventilation via intubation of trachaeostomy.|Retrospective data collected on or before the date of abstraction.||||days||95% Confidence Interval|Median
2678797|NCT01419028|Primary|Survival|Overall survival is defined as the time from birth to time of death.|Retrospective data collected on or before the data of abstraction.||||days||95% Confidence Interval|Median
2678798|NCT01418937|Primary|Number of Pregnant Subjects Reporting Pregnancy Outcomes|The pregnancy outcomes were based on reports from pregnant subjects in the study population. Pregnancy outcomes are pregnancies resulting in live births.|Throughout the study period (from Month 0 up to Month 12)|The analysis was performed on the number of pregnant subjects participating in the study.|||Subjects|||Number
2678799|NCT01418937|Primary|Number of Subjects With Medically Significant Conditions (MSCs)|MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|Throughout the study period (from Month 0 up to Month 12)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered|||Subjects|||Number
2684210|NCT01369784|Secondary|MUM-1 Expression|immunohistochemical reaction of cells with MUM-1 antibody|At the beginning of the 2nd line of treatment||||percentage of participants|||Number
2678801|NCT01418937|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the study period (from Month 0 up to Month 12)|The analysis was based on the Total Vaccinated cohort, which included all subjects with the study vaccine administered|||Subjects|||Number
2678802|NCT01418703|Secondary|Mean Glucose|Average plasma glucose concentration in mg/dl|Throughout each 22-hour closed-loop and open-loop admission for sCTR and eCTR||||mg/dL||Standard Deviation|Mean
2678803|NCT01418703|Secondary|Percent Time Spent in Near Normoglycemia|Comparison of time spent in near normoglycemia (3.9 to 10 mmol/mL) in open-loop vs closed-loop sCTR and eCTR.|Throughout each 22-hour closed-loop and open-loop admission for sCTR and eCTR||||percentage of time||Standard Deviation|Mean
2678804|NCT01418703|Primary|Hypoglycemic Events|Number of hypoglycemic events below 70 mg/dL per patient per day|Throughout each 22-hour closed-loop and open-loop admission for sCTR and eCTR||||events/admission per patient||Standard Deviation|Mean
2678805|NCT01418482|Secondary|Pain|To evaluate pain during dressing removal at visit 4,(after one week) with John Hopkins pain scale. Measured 0=no pain, 100= worst pain, scale from 0-100 mm|3 weeks||||units on a scale||Inter-Quartile Range|Median
2678806|NCT01418482|Secondary|Evaluate the Comfort|Comfort level and overall experience were each assessed using a scale that ranged from very poor to very good.|3 weeks||||participants|||Number
2678807|NCT01418482|Primary|Evaluate the Experience of Using Mepilex Border Ag ( a Silver Dressing) in Normal Clinical Practice|burns healed|3 weeks|small thickness partial burns|||burns healed|||Number
2678808|NCT01418378|Secondary|Radiographic Evaluation of Maximum Flexion|Maximum knee flexion measured radiographically at 1 year time point|1 year time point|Subjects at 1 year within safety population with complete, available data|||Degrees||Standard Deviation|Mean
2678809|NCT01418378|Secondary|Number of Subjects With Radiolucencies - Tibial Component|"The bone-implant interface at the tibial components were examined radiographically and radiolucencies were measured in millimeters.~Radiolucent lines (RLLs) greater than 2mm are considered to be clinically significant.~Radiolucent lines greater than 2mm are considered to be clinically significant."|6 weeks to 24 months|Subjects within safety population with complete, available data|||Participants|||Count of Participants
2678810|NCT01418378|Secondary|Number of Subjects With Radiolucencies - Femoral Component|"The bone-implant interface at the femoral components were examined radiographically and radiolucencies were measured in millimeters.~Radiolucent lines (RLLs) greater than 2mm are considered to be clinically significant."|6 to 12 week and 24 month intervals|Subjects within safety population with complete, available data|||Participants|||Count of Participants
2678811|NCT01418378|Secondary|Alignment - Tibial Posterior Slope|Alignment - Tibial Posterior Slope measured at 2 year time point. This angle is measured between a line through the center of the side of the tibia and the top flat surface of the tibial implant|2 year time point|Subjects at 2 years within safety population with complete, available data|||Degrees||Standard Deviation|Mean
2678812|NCT01418378|Secondary|Alignment - Tibial Posterior Slope|Tibial Posterior Slope measured at 1 year time point. This angle is measured between a line through the center of the side of the tibia and the top flat surface of the tibial implant|1 year time point|Subjects at 1 year within safety population with complete, available data|||Degrees||Standard Deviation|Mean
2678813|NCT01418378|Secondary|Alignment - Femoral Component Flexion|Alignment - Femoral Component Flexion measured at 2 year time point. This measures the angle between a line drawn though the center of the side of the femur and a line drawn across the top of the flat inner surface of the femoral component.|2 year time point|Subjects at 2 years within safety population with complete, available data|||Degrees||Standard Deviation|Mean
2678814|NCT01418378|Secondary|Alignment - Femoral Component Flexion|Femoral Component Flexion measured at 1 year time point. This measures the angle between a line drawn though the center of the side of the femur and a line drawn across the top of the flat inner surface of the femoral component.|1 year time point|Subjects at 1 year within safety population with complete, available data|||Degrees||Standard Deviation|Mean
2678815|NCT01418378|Secondary|Alignment - Tibial Component to Anatomic Angle|Tibial component angle measured at 2 year time point. This angle is measured between a line drawn from the center of the femoral head tibial implant.|2 year time point|Subjects at 2 year within safety population with complete, available data|||Degrees||Standard Deviation|Mean
2678816|NCT01418378|Secondary|Alignment - Tibial Component to Anatomic Angle|Tibial component angle measured at 1 year time point. This angle is measured between a line drawn from the center of the femoral head tibial implant.|1 year time point|Subjects at 1 year within safety population with complete, available data|||Degrees||Standard Deviation|Mean
2678817|NCT01418378|Secondary|Alignment - Femoral Component to Anatomic Angle|Femoral component angle measured at 2 year time point. This angle is measured between a line drawn from the center of the femoral head and a line across the bottom of the femoral implant (condyles).|2 year time point|Subjects at 2 year within safety population with complete, available data|||Degrees||Standard Deviation|Mean
2678818|NCT01418378|Secondary|Alignment - Femoral Component to Anatomic Angle.|Femoral component angle measured at 1 year time point. This angle is measured between a line drawn from the center of the femoral head and a line across the bottom of the femoral implant (condyles).|1 year time point|Subjects at 1 year within safety population with complete, available data|||Degrees||Standard Deviation|Mean
2678819|NCT01418378|Secondary|Anatomic Alignment Angle|"Anatomic angle measured at 2 year time point.~If one draws a line from the center of the hip joint to the center of the ankle joint this is considered to be the mechanical axis of the femur.~A line drawn through the center of the femoral shaft is the anatomic axis.~The angle created at the intersection of these lines is referred to as the anatomic alignment angle.~A normal angle is approximately 7-9 degrees valgus or slightly knock-kneed. Varus angles are less common and are also referred to as bow-legged."|2 year time point|Subjects at 2 years within safety population with complete, available data|||Participants|||Count of Participants
2678883|NCT01417377|Secondary|Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC)||Up to 6 months|The number of doses were not collected because the participants never achieved Hb level of 11 to 12 g/dL.||||||
2719666|NCT01102218|Secondary|Observe Changes in Markers of Inflammation Including But Not Limited to TNF-α and IL-6||6 months|||||||
2678820|NCT01418378|Secondary|Anatomic Alignment Angle|"Anatomic angle measured at 1 year time point.~If one draws a line from the center of the hip joint to the center of the ankle joint this is considered to be the mechanical axis of the femur.~A line drawn through the center of the femoral shaft is the anatomic axis.~The angle created at the intersection of these lines is referred to as the anatomic alignment angle.~A normal angle is approximately 7-9 degrees valgus or slightly knock-kneed. Varus angles are less common and are also referred to as bow-legged."|1 year time point|Subjects at 1 year within safety population with complete, available data|||Participants|||Count of Participants
2678821|NCT01418378|Secondary|Total Knee Society Knee Score at 2 Years|"Total Knee Society Knee Score change from baseline at 2 years~The Total Knee Society Score is comprised of two scores: the Knee Score and the Function Score. Both have a 0-100 range. Sub-scales are combined to compute a total score of 100~The Total Knee Society Score is made up of pain, range of motion, alignment and stability subscores. An Excellent score is 80-100, a good score is 70-79, a fair score is 60-69 and a poor score is anything below 60."|2 years|Subjects at 2 years within per protocol population with complete, available data|||Scores on a scale||Standard Deviation|Mean
2678822|NCT01418378|Secondary|Total Knee Society Score at 1 Year|"Total Knee Society Knee Score change from baseline at 1 year~The Total Knee Society Score is comprised of two scores: the Knee Score and the Function Score. Both have a 0-100 range. Sub-scales are combined to compute a total score of 100~The Total Knee Society Score is made up of pain, range of motion, alignment and stability subscores. An Excellent score is 80-100, a good score is 70-79, a fair score is 60-69 and a poor score is anything below 60."|1 year|Subjects at 1 year within per protocol population with complete, available data|||Scores on a scale||Standard Deviation|Mean
2678823|NCT01418378|Secondary|Number of Participants With Flexion Contracture at 2 Years|Summary of flexion contracture at 2 year time point.Flexion contracture is a shortening of the muscles that prevents the leg from fully extending|2 years|Subjects at 2 years within per protocol population with complete, available data|||Participants|||Count of Participants
2678824|NCT01418378|Secondary|Number of Participants With Flexion Contracture at 1 Year|Summary of flexion contracture at 1 year time point. Flexion contracture is a shortening of the muscles that prevents the leg from fully extending|1 years|Subjects at 1 year within per protocol population with complete, available data|||Participants|||Count of Participants
2678825|NCT01418378|Secondary|Change From Baseline in Goniometer Measured Maximum Total Range of Motion at 2 Years.|Comparative evaluation of the change from baseline values in 2 year goniometer-measured total range of motion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Total range of motion is the full distance the lower leg travels in relation to the upper leg.|2 years|Subjects at 2 years within per protocol population with complete, available data|||degrees||Standard Deviation|Mean
2678826|NCT01418378|Secondary|Change From Baseline in Goniometer Measured Maximum Total Range of Motion at 1 Year|Comparative evaluation of the change from baseline values in 1 year goniometer-measured total range of motion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Total range of motion is the full distance the lower leg travels in relation to the upper leg.|1 year|Subjects at 1 year within per protocol population with complete, available data|||degrees||Standard Deviation|Mean
2678827|NCT01418378|Secondary|Change From Baseline in Goniometer Measured Maximum Passive Extension at 2 Years|Comparative evaluation of the change from baseline values in 2 year goniometer-measured passive extension. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Passive extension involves moving the leg without active muscle contraction|2 year|Subjects at 2 years within per protocol population with complete, available data|||degrees||Standard Deviation|Mean
2678828|NCT01418378|Secondary|Change From Baseline in Goniometer Measured Maximum Passive Extension at 1 Year|Comparative evaluation of the change from baseline values in 1 year goniometer-measured passive extension. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Passive extension involves the leg being moved without active muscle contraction|1 year|Subjects at one year within per protocol population with complete, available data|||degrees||Standard Deviation|Mean
2678829|NCT01418378|Secondary|Change From Baseline in Goniometer Measured Maximum Passive Flexion at 1 Year.|Comparative evaluation of the change from baseline values in 1 year goniometer-measured passive Flexion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg. Passive flexion involves moving the leg through range of motion without active muscle contraction|1 year|Subjects at 1-year within per protocol population with complete, available data|||degrees||Standard Deviation|Mean
2678830|NCT01418378|Secondary|Knee Injury and Osteoarthritis Outcome - Quality of Life Subscore - 2 Years|"Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Quality of Life Subscore~The subscore ranges from 0 (no difficulty) to 16 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale.~100 - (score x 100) / 16 = transformed score"|2 years|Study subjects at 2 years - Subjects within per protocol population with complete, available data|||Scores on a scale||Standard Deviation|Mean
2678831|NCT01418378|Secondary|Knee Injury and Osteoarthritis Outcome - Quality of Life Subscore - 1 Years|"Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Activities of Quality of life Subscore~The subscore ranges from 0 (no difficulty) to 16 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale.~100 - (score x 100) / 16 = transformed score"|1 year|Study subjects at 1 years - Subjects within per protocol population with complete, available data|||Scores on a scale||Standard Deviation|Mean
2678832|NCT01418378|Secondary|Knee Injury and Osteoarthritis Outcome Sport and Recreation Subscore - 2 Years|"Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Activities of Daily Living Subscore~The subscore ranges from 0 (no difficulty) to 20 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale.~100 - (score x 100) / 20 = transformed score"|2 year|Study subjects at 2 years - Subjects within per protocol population with complete, available data|||Scores on a scale||Standard Deviation|Mean
2680325|NCT01402102|Secondary|Changes in Apo-B(Apolipoprotein B)|Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||g/L||Standard Deviation|Mean
2678833|NCT01418378|Secondary|Knee Injury and Osteoarthritis Outcome - Sport and Recreation Subscore - 1 Years|"Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Activities of Daily Living Subscore~The subscore ranges from 0 (no difficulty) to 20 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale.~100 - (score x 100) / 20 = transformed score"|1 year|Study subjects at 1 years - Subjects within per protocol population with complete, available data|||Scores on a scale||Standard Deviation|Mean
2678834|NCT01418378|Secondary|Knee Injury and Osteoarthritis Outcome - Activities of Daily Living Subscore - 2 Years|"Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Activities of Daily Living Subscore~The subscore ranges from 0 (no difficulty) to 68 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale.~100 - (score x 100) / 68 = transformed score"|2 year|Study subjects at 2 years - Subjects within per protocol population with complete, available data|||Scores on a scale||Standard Deviation|Mean
2678835|NCT01418378|Secondary|Knee Injury and Osteoarthritis Outcome - Activities of Daily Living Subscore - 1 Years|"Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Symptom Subscore~The subscore ranges from 0 (no difficulty) to 68 (extreme difficulty). The subscore is then transformed into a 0 (extreme difficulty) to 100 (no difficulty) scale.~100 - (score x 100) / 68 = transformed score"|1 year|Study subjects at 1 year - Subjects within per protocol population with complete, available data|||Scores on a scale||Standard Deviation|Mean
2678836|NCT01418378|Secondary|Knee Injury and Osteoarthritis Outcome Symptom Subscore - 2 Years|"Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Symptom Subscore~The subscore ranges from 0 (never have symptoms) to 28 (always have symptoms). The subscore is then transformed into a 0 (always have symptoms) to 100 (never have symptoms) scale.~100 - (score x 100) / 28 = transformed score"|2 years|Study subjects at 2 year -Subjects within per protocol population with complete, available data|||Scores on a scale||Standard Deviation|Mean
2678837|NCT01418378|Secondary|Knee Injury and Osteoarthritis Outcome Symptoms Subscore - 1 Years|"Comparative evaluation of the change from baseline values at 1 year in Knee Injury and Osteoarthritis Outcome Symptom Subscore~The subscore ranges from 0 (no symptoms) to 36 (always have symptoms). The subscore is then transformed into a 0 (always have symptoms) to 100 (never have symptoms) scale.~100 - (score x 100) / 36 = transformed score"|1 years|Study subjects at 1 year - Subjects within per protocol population with complete, available data|||Scores on a scale||Standard Deviation|Mean
2678838|NCT01418378|Secondary|Knee Injury and Osteoarthritis Outcome Pain Subscore - 2 Years|"Comparative evaluation of the change from baseline values at 2 years in Knee Injury and Osteoarthritis Outcome Pain Subscore~The subscore ranges from 0 (no pain) to 36 (extreme pain). The subscore is then transformed into a 0 (extreme pain) to 100 (no pain) scale.~100 - (score x 100) / 36 = transformed score"|2 years|Study subjects at 2 years - Subjects within per protocol population with complete, available data|||Scores on a scale||Standard Deviation|Mean
2678839|NCT01418378|Secondary|Knee Injury and Osteoarthritis Outcome Pain Subscore - 1 Year|"Comparative evaluation of the change from baseline values at 1 years in Knee Injury and Osteoarthritis Outcome Pain Subscore~The subscore ranges from 0 (no pain) to 36 (extreme pain). The subscore is then transformed into a 0 (extreme pain) to 100 (no pain) scale.~100 - (score x 100) / 36 = transformed score"|Pre-operative baseline to 1 year|Subjects within per protocol population with complete, available data|||Scores on a scale||Standard Deviation|Mean
2678840|NCT01418378|Secondary|Change From Baseline in Goniometer Measured Maximum Passive Flexion at 2 Years|Comparative evaluation of the change from baseline values in 2 year goniometer-measured passive flexion. A goniometer is an instrument used to measure angles in degrees and captures the change in angle between the upper and lower leg|Pre-operative baseline to 2 years|Per protocol population|||degrees||Standard Deviation|Mean
2678841|NCT01418378|Primary|Percentage of Knees Who Survived at 2 Years Post-operative|The Kaplan-Meier success rate at 24-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no components revised for any reason) was censored at the time of last follow-up.|2 Years|Safety population|||Percentage of Knees remaining||95% Confidence Interval|Number
2678842|NCT01418365|Primary|Maximum Plasma Concentration (Cmax) at Steady State for Metronidazole|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set|||ng/ml||Standard Deviation|Mean
2678843|NCT01418365|Primary|Area Under the Plasma Concentration Curve (AUC) at Steady State for Metronidazole|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. The Safety Analysis Set consists of subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.|||ng*h/ml||Standard Deviation|Mean
2678844|NCT01418209|Secondary|Perceived Hot Flash Interference (Hot Flash Related Daily Interference Scale; HFRDIS) -- Week 8|The perceived hot flash related daily interference scale (HFRDIS) is a tool for assessing the impact of hot flashes on quality of life. There are 10 questions with each having a score ranging from 0 to 10. The scores from each question are summed for a total score ranging from 0 to 100. Lower numbers indicate less interference and higher numbers indicate more interference.|Week 8|Intention-to-treat, i.e., all participants with follow-up data were included.|||units on a scale||95% Confidence Interval|Mean
2678845|NCT01418209|Secondary|Perceived Hot Flash Interference (Hot Flash Related Daily Interference Scale; HFRDIS) -- Week 4|The perceived hot flash related daily interference scale (HFRDIS) is a tool for assessing the impact of hot flashes on quality of life. There are 10 questions with each having a score ranging from 0 to 10. The scores from each question are summed for a total score ranging from 0 to 100. Lower numbers indicate less interference and higher numbers indicate more interference.|Week 4|Intention-to-treat, i.e., all participants with follow-up data were included.|||units on a scale||95% Confidence Interval|Mean
2678884|NCT01417377|Secondary|Number of Dose Adjustments Required to Maintain Hb Levels||Up to 6 months|None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed.||||||
2678846|NCT01418209|Secondary|Bothersomeness of Hot Flashes -- Week 8|Measured by self-report diary twice daily (day and night) for 7 days. Bothersomeness ratings ranged from 0 to 3 with lower numbers being less bothersome and higher numbers being more bothersome. Data from the day and night bothersomeness ratings were averaged for a single daily score. The single daily scores for the week prior to the week 8 study assessment were summed and averaged to produce a mean daily VMS bothersomeness for week 8.|Week 8|Intention-to-treat, i.e., all participants with follow-up data were included.|||units on a scale||95% Confidence Interval|Mean
2678847|NCT01418209|Secondary|Bothersomeness of Hot Flashes -- Week 4|Measured by self-report diary twice daily (day and night) for 7 days. Bothersomeness ratings ranged from 0 to 3 with lower numbers being less bothersome and higher numbers being more bothersome. Data from the day and night bothersomeness ratings were averaged for a single daily score. The single daily scores for the week prior to the week 4 study assessment were summed and averaged to produce a mean daily VMS bothersomeness for week 4.|Week 4|Intention-to-treat, i.e., all participants with follow-up data were included.|||units on a scale||95% Confidence Interval|Mean
2678848|NCT01418209|Primary|Frequency of Hot Flashes (Daily Vasomotor Symptom [VMS] Frequency) -- Week 8|Measured by self-report diary twice daily (day and night). The day and night frequencies were summed to produce a single number of hot flashes per day. The single number of hot flashes per day were summed and averaged for one week prior to the week 8 study assessment to produce a mean daily frequency for week 8.|Week 8|Intention-to-treat, i.e., all participants with follow-up data were included.|||number of hot flashes per day||95% Confidence Interval|Mean
2678849|NCT01418209|Secondary|Severity of Hot Flashes -- Week 8|Measured by self-report diary twice daily (day and night) for 7 days. Severity ratings ranged from 0 to 3 with lower numbers being less severe and higher numbers being more severe. Data from the day and night severity ratings were averaged for a single daily score. The single daily scores for the week prior to the week 8 study assessment were summed and averaged to produce a mean daily VMS severity for week 8.|Week 8|Intention-to-treat, i.e., all participants with follow-up data were included.|||units on a scale||95% Confidence Interval|Mean
2678850|NCT01418209|Secondary|Severity of Hot Flashes -- Week 4|Measured by self-report diary twice daily (day and night) for 7 days. Severity ratings ranged from 0 to 3 with lower numbers being less severe and higher numbers being more severe. Data from the day and night severity ratings were averaged for a single daily score. The single daily scores for the week prior to the week 4 study assessment were summed and averaged to produce a mean daily VMS severity for week 4.|Week 4|Intention-to-treat, i.e., all participants with follow-up data were included.|||units on a scale||95% Confidence Interval|Mean
2678851|NCT01418209|Primary|Frequency of Hot Flashes (Vasomotor Symptom [VMS] Frequency) -- Week 4|Measured by self-report diary twice daily (day and night). The day and night frequencies were summed to produce a single number of hot flashes per day. The single number of hot flashes per day were summed and averaged for one week prior to the week 4 study assessment to produce a mean daily frequency for week 4.|Week 4|Intention-to-treat, i.e., all participants with follow-up data were included.|||number of hot flashes per day||95% Confidence Interval|Mean
2678852|NCT01418001|Secondary|Pathologic Response|will be assessed by both MRI and by pathologic review after surgery. An estimate of each response rate and the 95% CI will be provided|2 years|No data is available because data was not collected due to lack of accrual.||||||
2678853|NCT01418001|Primary|Overall Objective Response|"Overall objective response measured using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.~Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|Every 6 weeks up to 2 years||||participants|||Number
2678854|NCT01417936|Secondary|Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Death and AEs Leading to Discontinuation|An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.|From the first dose of study drug administration up to 4 weeks after the last dose of study drug administration|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.|||Subjects|||Number
2678855|NCT01417936|Secondary|Volume of Distribution (Vz)|Volume of distribution was defined as the theoretical volume in which the total amount of drug needed to be uniformly distributed to produce the desired serum concentration of a drug.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.|||milliliter/kilogram||Standard Deviation|Mean
2678856|NCT01417936|Secondary|Time to Reach Minimum Serum Concentration (Tmin)||Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.|||hour||Standard Deviation|Mean
2678857|NCT01417936|Secondary|Time to Reach Maximum Serum Concentration (Tmax)||Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.|||hour||Standard Deviation|Mean
2678885|NCT01417377|Secondary|Time to Achieve Hb Level to 11-12 g/dL||Up to 6 months|None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed.||||||
2719667|NCT01102218|Secondary|Examine the EPO Resistance Index (Erythropoietin Dose/kg/Week/Hgb) or ERI Over Time||6 months|||||||
2678858|NCT01417936|Secondary|Terminal Half Life (T1/2)|The apparent terminal half-life was defined as the time required for the serum concentration of Sym004 to decrease 50% in the final stage of its elimination.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.|||hour||Standard Deviation|Mean
2678859|NCT01417936|Secondary|Clearance (CL)|Clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.|||milliliter/hour/kilogram||Standard Deviation|Mean
2678860|NCT01417936|Secondary|Minimum Serum Concentration (Cmin)||Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.|||microgram/milliliter||Standard Deviation|Mean
2678861|NCT01417936|Secondary|Maximum Serum Concentration (Cmax)||Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.|||microgram/milliliter||Standard Deviation|Mean
2678862|NCT01417936|Secondary|Area Under the Serum Concentration Curve From Time Zero to Infinity (AUC [0-inf])|The AUC (0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.|||microgram-hour/milliliter||Standard Deviation|Mean
2678863|NCT01417936|Secondary|Area Under the Serum Concentration Curve From Time Zero to 168 Hours (AUC [0-168])|The AUC (0-168h) was estimated by determining the total area under the curve of the concentration versus time curve.|Pre-treatment, 1, 2, 4, 8, 24, and 48 hours post-infusion at Week 0 and Week 3|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. ‘n’ signifies subjects who were evaluable at given time points.|||microgram-hour/milliliter||Standard Deviation|Mean
2678864|NCT01417936|Secondary|Number of Subjects With Detectable Biomarkers at Any Visit|The biomarkers human papilloma virus (HPV), mutated epidermal growth factor receptor (EGFRvIII), c-MET and human epidermal growth factor receptor (HER) 2, HER3 were analyzed only in tumor cells while EGFR, phosphorylated epidermal growth factor receptor (pEGFR), and Ki-67 were analyzed both in tumor and skin biopsy cells.|Weeks 0 and 4; and 4 weeks after last dose|"The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment. n signifies subjects evaluable for specified biomarker type."|||Subjects|||Number
2678865|NCT01417936|Secondary|Overall Survival Time|Overall survival time was defined as the time from first infusion of Sym004 until date of death. Subjects who withdraw the consent or lost to follow-up were censored.|Time from first infusion of Sym004 until death, assessed up to 18 months|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.|||days||95% Confidence Interval|Median
2678866|NCT01417936|Secondary|Time to Progression (TTP)|The TTP was defined as the time from first infusion of Sym004 until disease progression according to RECIST Version 1.1 criteria. Disease progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The subjects who died without prior assessment of PD were censored for TTP.|Time from first infusion of Sym04 until disease progression, assessed up to 18 months|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.|||days||95% Confidence Interval|Median
2678867|NCT01417936|Secondary|Duration of Overall Response|Duration of overall response was defined as the time from the first time point where measurement criteria are met for CR or PR until first date of recurrence or PD was objectively documented according to RECIST Version 1.1. Duration of overall response was censored at date of last imaging data of measured lesions if no confirmation of recurrence or PD was available.|Time from first infusion of Sym004 until disease progression or death, assessed up to 18 months|Duration of overall response could not be calculated as no subject showed CR or PR.||||||
2678868|NCT01417936|Secondary|Objective Tumor Response and Derived Endpoints (Objective Response Rate and Disease Control Rate)|"Best objective tumor response was defined as the occurrence of complete response (CR), partial response (PR), stable disease (SD), or PD according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.~Objective response was defined as the occurrence of CR or PR according to RECIST Version 1.1. Disease control was defined as the occurrence of CR, PR or SD according to RECIST Version 1.1.~CR: Disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 mm; PR: At least a 30% decrease in the sum of diameters of all - lesions, taking as reference the baseline sum diameters; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on trial."|Time from first infusion of Sym004 until disease progression or death, assessed up to 18 months|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.|||Percentage of subjects||95% Confidence Interval|Number
2678886|NCT01417377|Primary|Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study||Month 4 up to Month 6|None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed.||||||
2678922|NCT01416636|Secondary|Effect on N-terminal Pro-BNP Levels|"baseline values, assessment after 12 and 24 weeks~As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 46 patients randomized to high dose group and 46 patients in low dose group."|Baseline and 24 weeks||||percentage change to baseline||Standard Deviation|Mean
2678869|NCT01417936|Primary|Progression Free Survival (PFS) Time|The PFS time was defined as the time from first infusion of Sym004 until progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. or death. PD was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The unequivocal progression of existing non-target lesions and the appearance of one or more lesions was also considered progression. Subjects who died without confirmed PD were considered as progressed. Subjects who died or showed PD more than 21 days after last treatment were censored (that is, were considered alive without progression on Day 21 after last treatment). Evaluation was done using Kaplan-Meier estimates.|Time from the first infusion of Sym004 until progressive disease or death, assessed up to 24 weeks|The FAS comprised all subjects who had been exposed to trial drug irrespective of their compliance to the planned course of treatment.|||days||95% Confidence Interval|Median
2678870|NCT01417741|Primary|Postoperative Nausea and Vomiting|Post operative Nausea and vomiting in phase 1 and 11 recovery (Measured as a percentage of participants who experienced this outcome) Post op Nausea and vomiting on post op day one ( measured as a percentage of participants who experienced this outcome) as reported on a telephone survey|24 hours||||Participants|||Count of Participants
2678871|NCT01417481|Secondary|Changes in Other Spirometric Variables|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).|8 weeks||||Percentage of baseline||Standard Error|Mean
2678872|NCT01417481|Secondary|Changes in FEV1, FEF25, and FEFmax|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).|8 weeks||||Percentage of baseline||Standard Error|Mean
2678873|NCT01417481|Secondary|Changes in Pulse Oximetry, FEV1/FVC, and FEF50.|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).|8 weeks||||Percentage of baseline||Standard Error|Mean
2678874|NCT01417481|Secondary|Changes in Score for Sputum Production, Dyspnea and Global Symptoms|"To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).~In the symptoms questionnaire, each respiratory symptom (Cough severity, Sputum features, Appetite, Dyspnea, and Energy perception) was evaluated in a 5-options Likert scale, ranging from 1 (better) to 5 (worse). The total score was computed by the simple sum of the five symptoms."|8 weeks||||Percentage of baseline||Standard Error|Mean
2678875|NCT01417481|Primary|Changes in Sputum Concentration of Inflammatory Biomarkers (G-CSF)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentage change was log-transformed to adjust to a normal distribution.|8 weeks||||log (percent change)||Standard Error|Mean
2678876|NCT01417481|Primary|Changes in Sputum Concentration of Inflammatory Biomarkers (IL-6)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentage change was log-transformed to adjust to a normal distribution.|8 weeks|From the 13 patients who initiated the study, some children did not expectorate at some visits. Thus, only a non-paired population of 9 children under glycine and 11 under placebo could be analyzed.|||log (percent change)||Standard Error|Mean
2678877|NCT01417481|Primary|Changes in Serum Concentration of Inflammatory Biomarkers (TNF-alpha)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentages were log-transformed to adjust to a normal distribution.|8 weeks|From the 13 patients who initiated the study, some parents did not give consent for blood sampling, and some children refused the venous puncture at some visits. Thus, only a non-paired population of 9 children per group could be analyzed.|||log (percent change)||Standard Error|Mean
2678878|NCT01417481|Primary|Changes in Sputum Concentration of Inflammatory Biomarkers (Other Than IL-6 and G-CSF)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentage change was log-transformed to adjust to a normal distribution.|8 weeks|From the 13 patients who initiated the study, some children at some visits could not give an appropriate sputum sample. Thus, only a non-paired population of 9 (glycine group) and 11 (placebo group) children could be analyzed.|||log (percent change)||Standard Error|Mean
2678879|NCT01417481|Primary|Changes in Serum Concentration of Inflammatory Biomarkers (Other Than TNF-alpha)|To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]). Then, percentages were log-transformed to adjust to a normal distribution.|8 weeks|From the 13 patients who initiated the study, some parents did not give consent for blood sampling, and some children refused the venous puncture at some visits. Thus, only a non-paired population of 9 children per group could be analyzed.|||log (percent change)||Standard Error|Mean
2678880|NCT01417481|Secondary|Changes in Clinical Data Scores (Other Than Sputum Production, Dyspnea and Global Symptoms)|"To correct for the baseline variability, all measurements were expressed as percentage of baseline (value at week 8 with respect to baseline value [beginning of the glycine or placebo period, respectively]).~Each respiratory symptom (Cough severity, Sputum features, Appetite, Dyspnea, and Energy perception) was evaluated in a 5-options Likert scale, ranging from 1 (better) to 5 (worse). The total score was computed by the simple sum of the five symptoms."|8 weeks||||Percentage of baseline||Standard Error|Mean
2678881|NCT01417455|Primary|Osteoclast Activity Ex-vivo|Total area resorbed by osteoclasts as percentage of total area analyzed|at baseline and at 6 months||||percentage of resorbed area||Inter-Quartile Range|Median
2678882|NCT01417455|Primary|Osteoclast Differentiation Ex-vivo|Osteoclasts will be differentiated from untreated patients and patients under several TNF blockers.|at baseline and at 6 months||||OC/mm2||Inter-Quartile Range|Median
2678887|NCT01417195|Secondary|Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS)|A treatment-emergent AE was any AE occurring after start of investigational medicinal product (IMP) and within the time of residual drug effect, or a pretreatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. The time of residual drug effect was the estimated period of time after the last dose of the IMP, where the effect of the product was still considered to be present based on pharmacokinetic, pharmacodynamic, or other IMP characteristics.|Day 1 up to Day 20|Safety population|||participants|||Number
2678888|NCT01417195|Secondary|Summary of Assessor Questionnaire on Day 6|"Participants assigned to the Menopur and Bravelle treatment arm prepared and self-administered her daily dose on Day 6 in the presence of the study coordinator or designee assessor. The assessor then completed a 7 question questionnaire with YES or NO answers to document their assessment of participant understanding of drug administration procedures. Reported data represent the number of participants for whom the assessor answered the question YES.~Gonadotropins are referred to as investigational medicinal product (IMP)."|Day 6|Intent to treat population for the combination treatment arm only|||participants|||Number
2678889|NCT01417195|Secondary|Summary of Assessor Questionnaire on Day 1|"Participants assigned to the Menopur and Bravelle treatment arm read the Mixing Instructions Guide on how to mix and administer the medications at home. Participants were given enough time to read and understand the instructions and ask any questions. After completing the SCQ, participants prepared and self-administered her assigned first daily dose in the presence of the study coordinator or designee assessor. The assessor then completed a 7 question questionnaire with YES or NO answers to document their assessment of participant understanding of drug administration procedures. Reported data represent the number of participants for whom the assessor answered the question YES.~Gonadotropins are referred to as investigational medicinal product (IMP)."|Day 1|Intent to treat population for the combination treatment arm only|||participants|||Number
2678890|NCT01417195|Secondary|Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6|Subject comprehension questionnaires were repeated on Day 6 after 5 days of combination therapy by participants assigned to the Menopur and Bravelle treatment arm. The SCQ consists of 7 questions with YES/NO answers to self-gauge participants' understanding of drug administration procedures. Reported data represent the number of participants who answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP).|Day 6|Intent to treat population for the combination treatment arm only|||participants|||Number
2678891|NCT01417195|Secondary|Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1|Subject comprehension questionnaires were completed on Day 1 only by participants assigned to the Menopur and Bravelle treatment arm. On Day 1, the participant read the Mixing Instructions Guide on how to mix and administer the medications at home. The participant was given enough time to read and understand the instructions and ask any questions. The participant then completed the SCQ which consists of 7 questions with YES/NO answers, to self-gauge their understanding of drug administration procedures. Reported data represent the number of participants who answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP).|Day 1|Intent to treat population for the combination treatment arm only|||participants|||Number
2678892|NCT01417195|Primary|Fertilization Rate|The fertilization rate was defined for each participant and calculated as the number of 2 pronuclei (fertilized) (2PN) oocytes divided by the total number of oocytes retrieved multiplied by 100.|approximately day 13 (16-20 hours post insemination by in vitro fertilization (IVF) insemination or intracytoplasmic sperm injection (ICSI))|Intent to treat population|||percentage of oocytes retrieved||Standard Deviation|Mean
2678893|NCT01417156|Secondary|Percentage of Patient With First Occurrence of Acute Exacerbations of Idiopathic Pulmonary Fibrosis (IPF) Until Week 234.|The percentage of patient having first acute exacerbation of Idiopathic Pulmonary Fibrosis (IPF) based on investigator reported adverse events until week 234.|Week 234|TS|||percentage of participants|||Number
2678894|NCT01417156|Secondary|Acute Exacerbations of IPF: Risk (Incidence Rate) of Acute Exacerbations of IPF.|The risk (incidence rate calculated as number of patients with at least 1 exacerbation, divided by the total time at risk ×100) of acute exacerbation of IPF.|First drug administration until end of treatment, up to 5 years|TS|||patients per 100 patient-year||95% Confidence Interval|Number
2678895|NCT01417156|Secondary|Annual Rate of Decline in Haemoglobin (Hb) Corrected Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)|"Adjusted annual rate of decline in Hb corrected DLCO. The means presents actually adjusted rate based on random coefficient regression with fixed effects for gender, age, height & random effect of patient specific intercept & time. Within-patient errors are modelled by Unstructured variance-covariance matrix.Inter-individual variability is modelled by a variance-Components variance−covariance matrix.~mmHg: millimeters of mercury"|Baseline & every 8 weeks after drug administration until end of treatment, up to 5 years|OC-TS|||mL/Minute(min)/mmHg per year||Standard Error|Mean
2678896|NCT01417156|Secondary|Annual Rate of Decline in Forced Vital Capacity (FVC).|"The adjusted annual rate of decline in Forced Vital Capacity (FVC). The means presents actually the adjusted rate based on a random coefficient regression with fixed effects for gender, age, height and random effect of patient specific intercept and time. Within−patient errors are modelled by an Unstructured variance−covariance matrix. Inter−individual variability is modelled by a Variance−Components variance−covariance matrix.~The result for Annual rate of decline (ROD) in FVC should be interpreted with caution and along with descriptive statistics, because inferences used for this analysis might not be valid as suggested by skewed distribution of the data."|Baseline and every 8 weeks after drug administration until end of treatment, up to 5 years|TS-OC Observed Case (OC): This method was used for the replacement of missing values.|||(mililitre (mL)/year)||Standard Error|Least Squares Mean
2678897|NCT01417156|Primary|Incidence of Overall Adverse Events|Incidence (Number of patients) of Adverse events (AEs) over the course of treatment period including serious adverse events (SAEs), AEs leading to discontinuation of study medication, and fatal AEs.|First drug administration until end of treatment, up to 5 years|Treated set (TS)|||participants|||Number
2678898|NCT01417104|Other Pre-specified|Change From Baseline in Resting Diastolic Blood Pressure|Difference between end of treatment and baseline in resting diastolic blood pressure|baseline to end of treatment ( up to 36 weeks)|Intent to treat analysis including only participants who had at least one post-baseline assesment|||mm Hg||95% Confidence Interval|Mean
2678899|NCT01417104|Secondary|Change in the Percentage Wall Volume (PWV) Between Baseline and End of Treatment|Using an approach similar to intravascular atheroma volume calculations, percentage wall volume (PWV) for thoracic region, abdominal region and total aorta for each patient and each exam was generated. and a difference between baseline and end of treatment was calculated.|Baseline and end of treatment ( 17 to 36 weeks)|3 MRI not analyzable, 23 final MRI not obtained due to trial termination|||Percentage of the Outer Wall Volume||Standard Deviation|Mean
2678900|NCT01417104|Primary|Change in Normalized Total Aortic Wall Volume (TWV) Between the Trial Arms at the End of the Treatment|"All patients underwent imaging using a 3T, MRI system. The MRI sequence method used for wall depiction was a 3D, fat suppressed, dark blood, turbo spin echo sequence with variable flip angles (SPACE). Following co-registration of pre and post treatment MR images, and generation of MPR sections, images were magnified, contrast adjusted and patient/exam identifier information was removed and replaced by pre-assigned code to blind images for measurements.~An experienced observer performed manual measurements of lumen and lumen plus wall areas by delineating the inner border and the outer border of the vessel wall in each cross-section image of the aorta. Using an approach similar to intravascular atheroma volume calculations, normalized total aortic wall volume (TWV) for thoracic region, abdominal region and total aorta for each patient and each exam was generated."|Baseline and end of treatment ( 17 to 36 weeks)|3 MRI data sets were not analyzable ( low quality images), and 23 post-treatment MRI not obtained ( <17 weeks on drug when trial terminated owing to ALTITUDE results)|||mm3||Standard Deviation|Mean
2678901|NCT01417078|Primary|Pharmacokinetic (PK) Parameter: Area Under The Concentration Curve From Time 0 to 12 Hours (AUC(0-12)) and AUC Time to Last Measurable Plasma Concentration|"Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter AUC(0-12) and AUC(last).~The mean estimate of AUC(0-12) was adjusted to a 20 mg dose. AUC(last) was used for the calculation of AUC for nordiazepam. AUC(0-12) values could not be estimated for nordiazepam given that nordiazepam concentrations were rising between 6 and 12 hours."|Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours|"PK Population: patients who had adequate concentration-time data to permit estimation of noncompartmental PK parameters.~One patient was not included in the analysis of nordiazepam due to receiving clorazepate, which interfered with the analysis of nordiazepam from diazepam administration."|||hour*nanogram/milliliter (h*ng/mL)||Standard Deviation|Mean
2678902|NCT01417078|Primary|Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax)|"Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Tmax.~The mean Tmax value was adjusted to a 20 mg dose."|Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours|"PK Population: patients who had adequate concentration-time data to permit estimation of noncompartmental PK parameters.~One patient was not included in the analysis of nordiazepam due to receiving clorazepate, which interfered with the analysis of nordiazepam from diazepam administration."|||hour (h)||Standard Deviation|Mean
2678903|NCT01417078|Secondary|Number of Patients With Treatment Emergent Adverse Events (TEAEs)|"TEAEs refer to adverse events with start dates occurring after dosing. Treatment-Related TEAEs refer to those 'possibly' or 'probably' related to study drug.~Intensity definitions:~Mild: Usually transient, required no special treatment, and did not interfere with the patient's daily activities.~Moderate: Usually caused a low degree of inconvenience or concern to the patient, and may have interfered with daily activities, but was usually ameliorated by simple therapeutic measures.~Severe: Interrupted a patient's usual daily activities, and generally required systemic drug therapy or other treatment."|Pre-dose to 48 hours post-dose|Safety Population (dosed with study drug)|||participants|||Number
2678904|NCT01417078|Primary|Pharmacokinetic (PK) Parameter: Maximum Measure Plasma Concentration (Cmax),|Summary of Dose-Adjusted Diazepam and Nordiazepam PK parameter Cmax. The mean Cmax value was adjusted to a 20 mg dose.|Pre-dose, 10, 15, 30, and 45 mins, and 1, 1.5, 2, 4, 6, 9,and 12 hours|"PK Population: patients who had adequate concentration-time data to permit estimation of noncompartmental PK parameters.~One patient was not included in the analysis of nordiazepam due to receiving clorazepate, which interfered with the analysis of nordiazepam from diazepam administration."|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2678905|NCT01417026|Secondary|"Changes From Baseline to Post-testing (After Max. 12 Days) on the Happy Faces Measure of Social Attention"|"The Happy Faces task requires that participants look at a series of faces of men and women. Faces are presented on the screen one by one and children are asked just to look at the faces. Eye movements are measured with a Tobii x120 tabletop eye-tracker to evaluate participants' looking patterns towards the eyes versus the mouth region."|Baseline and Post-testing (after max. 12 days)||||change in proportion of looking||Standard Deviation|Mean
2678906|NCT01417026|Primary|Change From Baseline to Post-testing (After Max. 12 Days) on the Reading the Mind in the Eyes Test (Child Version)|This is a test of emotion recognition. This test asks children to pick the best word out of four options to describe the mental state of a set of eyes. The test includes 28 photographs of eyes with both affective (e.g., upset) and cognitive (e.g., thoughtful) mental state words as choices.|Baseline and Post-testing (after max. 12 days)||||change in items correct||Standard Deviation|Mean
2678907|NCT01417026|Primary|Change From Baseline to Post-testing (After Max. 12 Days) on the Part/Whole Identity Test (LFI Skills Battery)|This test measures the extent to which the participant employed a featural or holistic face recognition strategy. A sample face is presented, followed by a test face composed of either two whole faces or two face parts.|Baseline and Post-testing (after max. 12 days)||||change in percent correct||Standard Deviation|Mean
2678908|NCT01417000|Secondary|To Assess Safety of the Cyclophosphamide, GVAX Pancreas Vaccine, and CRS-207 Treatment Regimen|Safety was assessed based upon the number of adverse events (AEs) that occurred in the FAS of each treatment arm, including serious AEs and total AEs. Total AEs included both serious and non-serious AEs. AEs reported for the Cy/GVAX + CRS-207 arm (FAS) include the 61 treated subjects initially assigned to this arm plus AEs occurring on/after the first rollover dose date for the 3 Cy/GVAX rollover subjects. AEs reported for the Cy/GVAX arm (FAS) include treated subjects initially assigned to this arm but exclude AEs for rollover subjects occurring on/after the first rollover dose date.|Starting with administration of first investigational drug product through 28 days after final study treatment, assessed up to 60 months from the date of randomization.|Analysis conducted for the FAS of each study arm.|||Participants|||Count of Participants
2679577|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walking Cane|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set|||participants|||Number
2678909|NCT01417000|Primary|Overall Survival (OS) in Subjects Receiving Test Treatments (FAS)|"For all treated subjects, OS was defined as the time between the date of randomization and the date of death or censoring, and was estimated using Kaplan-Meier (KM) methods with 95% confidence intervals (CIs). Subjects without documentation of death at the time of the final analysis were censored using the date the subject was last known to be alive. Per the study protocol, following an Interim Analysis (IA), subjects in the Cy/GVAX arm were offered rollover to Cy/GVAX + CRS-207 arm. 3 subjects rolled over to the Cy/GVAX + CRS-207 arm (rollover subjects). These rollover subjects were censored at the day prior to the first rollover treatment dose date, and were included for analysis in the Cy/GVAX arm. Additionally, 2 subjects originally treated per the Cy/GVAX + CRS-207 arm discontinued treatment and entered follow-up, but following IA were re-treated per the Cy/GVAX + CRS-207 arm regimen. Data from these re-treated subjects were included in the Cy/GVAX + CRS-207 arm analysis."|Subjects were followed from the date of randomization to the date of death or discontinuation, whichever came first, assessed up to 60 months.|Analysis conducted for the FAS of each study arm.|||months||95% Confidence Interval|Median
2678910|NCT01416987|Secondary|Number of Participants With Clinical Pregnancy as Per Effectiveness Analysis Set|The clinical pregnancy was defined as a positive serum in urine HCG test or as the presence of gestational sac or yolk sac by an ultrasonography confirmation.|2463 days|Effectiveness analysis set included participants who were evaluated for follicular growth (FG) after treatment with Pergoveris ®, except those; who were not assessed for FG; whose assessments of FG were considered 'undecidable' based on Human Chorionic Gonadotropin (HCG) not administered, ultrasonography not done on the day of HCG administration.|||Participants|||Count of Participants
2678911|NCT01416987|Secondary|Number of Participants With Clinical Pregnancy as Per Safety Analysis Set|The clinical pregnancy was defined as a positive serum in urine HCG test or as the presence of gestational sac or yolk sac by an ultrasonography confirmation.|2463 days|Safety analysis set included all participants who received at least one dose of Pergoveris®.|||Participants|||Count of Participants
2678912|NCT01416987|Secondary|Number of Participants With at Least One Follicle of More Than 17 Millimeter (mm) of Mean Diameter on Ultrasonography|Number of participants with one follicle of more than 17mm of mean diameter on ultrasonography were reported.|2463 days|Effectiveness analysis set included participants who were evaluated for follicular growth (FG) after treatment with Pergoveris®, except those; who were not assessed for FG; whose assessments of FG were considered 'undecidable' based on Human Chorionic Gonadotropin (HCG) not administered, ultrasonography not done on the day of HCG administration.|||Participants|||Count of Participants
2678913|NCT01416987|Primary|Number of Participants With Adverse Event (AE) and Adverse Drug Reaction (ADR)|Adverse Event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse events included both Serious AEs and non-serious AEs. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse Drug Reactions (ADR) was defined as an adverse event for which a causal relationship between the product and the occurrence was suspected, that was judged possible or probable by the reporting physician.|2463 days|Safety analysis set included all participants who received at least one dose of Pergoveris®.|||Participants|||Count of Participants
2678914|NCT01416805|Secondary|ADIS-C/P Clinical Severity Rating|Anxiety Disorders Interview Schedule for DSM-IV: Child and Parent Versions (ADIS-IV-C/P)- The ADIS-IV-C/P (Silverman & Albano, 1996) is a clinician-administered, semi-structured interview that assesses for the presence and severity of DSM-IV anxiety disorders as well as Dysthymia and Major Depression, ADHD, Conduct Disorder, and Oppositional-Defiant Disorder. Excellent psychometric properties have been reported (e.g., Wood et al., 2002). The Clinical Severity Rating score is a one item metric reflecting the severity of the anxiety diagnosis. This is rated by the clinician based on their interview with the patient and parent, together with their judgment. The Rating ranges from 0 to 8 with higher scores reflecting worse anxiety.|14 weeks||||units on a scale||Standard Deviation|Mean
2678915|NCT01416805|Primary|PARS|Pediatric Anxiety Rating Scale (PARS)- The PARS (RUPP, 2002) is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week. The scale score ranges from 0 to 30 with higher scores reflecting worse anxiety. The score, ranging from 0-30 represents a total score by summing all 6 items (which have item response options ranking from 0 to 5 each).|14 Weeks||||units on a scale||Standard Deviation|Mean
2678916|NCT01416636|Secondary|Effect on Signs & Symptoms of the CTEPH|baseline values, assessment after 24 weeks|Baseline and 24 weeks||||participants|||Number
2678917|NCT01416636|Secondary|Effect on Hemodynamic Parameter (mRap - Mean Right Atrial Pressure)|"baseline values, assessment after 24 weeks~As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 48 patients randomized to high dose group and 47 patients in low dose group."|Baseline and 24 weeks||||mmHg||Standard Deviation|Mean
2678918|NCT01416636|Secondary|Effect on Hemodynamic Parameter (mPAP - Mean Pulmonary Arterial Pressure)|"baseline values, assessment after 24 weeks~As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 47 patients randomized to high dose group and 47 patients in low dose group."|Baseline and 24 weeks||||mmHg||Standard Deviation|Mean
2678919|NCT01416636|Secondary|Effect on Hemodynamic Parameter (CO - Cardiac Output)|"baseline values, assessment after 24 weeks~As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 48 patients randomized to high dose group and 47 patients in low dose group."|Baseline and 24 weeks||||L/min||Standard Deviation|Mean
2678920|NCT01416636|Secondary|Effect on Hemodynamic Parameter (CI - Cardiac Index)|"baseline values, assessment after 24 weeks~As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 48 patients randomized to high dose group and 47 patients in low dose group."|Baseline and 24 weeks||||L/min/m2||Standard Deviation|Mean
2678921|NCT01416636|Secondary|Effect on Hemodynamic Parameter (PVR - Pulmonary Vascular Resistance)|"baseline values, assessment after 24 weeks~As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 48 patients randomized to high dose group and 47 patients in low dose group."|Baseline and 24 weeks||||dyn.s.cm^-5||Standard Deviation|Mean
2725360|NCT01059357|Secondary|Number of Participants With Blood Loss and Complications||6 months||||Participants|||Count of Participants
2678923|NCT01416636|Secondary|Effect on Quality of Life by the MINNESOTA Questionnaire|"This questionnaire is composed of 21 questions relating to limitations in lifestyle associated with Heart Failure. Respondents use a 5-point scale that ranges from 0 (none) to 5 (too much), with a score of 0 representing no limitation and a score of 5 representing maximum limitation. The change in individual score sum was evaluated and is displayed in the results, with a possible range of 0-105. Higher values indicate more limitations in Quality of Life.~As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 50 patients randomized to high dose group and 46 patients in low dose group."|Baseline and 24 weeks||||units on a scale||Standard Deviation|Mean
2678924|NCT01416636|Secondary|Change in WHO/NYHA (World Health Organization - New York Heart Association) Functional Class|"Class I - Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope.~Class II - Patients with pulmonary hypertension resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.~Class III - Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope~Class IV - Patients with pulmonary hypertension in the inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity."|Baseline and 24 weeks||||Participants|||Count of Participants
2678925|NCT01416636|Secondary|Effect on Maximal Borg Score During 6-minutes Walk Test|"The Borg scale was used for rating of dyspnea during 6-minutes walk test. The scale is defined from 0 to > 10 (upper bound) (0 = NOTHING AT ALL; 0.5 = VERY VERY SLIGHT (just noticeable); 1 = VERY SLIGHT; 2 = SLIGHT; 3 = MODERATE; 4 = SOMEWHAT SEVERE; 5 = SEVERE; 6-9 = VERY SEVERE; 10 = VERY VERY SEVERE (almost maximum); >10 MAXIMUM).~As can be seen with the scale, the higher scale values represent a worse outcome.~As no imputation rule applied only full-data sets were evaluated. Complete data sets were available for 48 patients randomized to high dose group and 48 patients in low dose group."|Baseline and 24 weeks|For this endpoint no imputation role was applied. For 48 patients of the high dose group, as well as for the low dose group, baseline data and also 24 week data are available.|||units on a scale||Standard Deviation|Mean
2678926|NCT01416636|Secondary|Number of Participants With Clinical Worsening|"Clinical worsening defined as a decrease of 6-minute walk test distance of more than 20% from baseline due to Chronic Thromboembolic Pulmonary Hypertension, decrease of New York Heart Association functional class, hospitalization with the requirement for additional Pulmonary Hypertension specific treatment and/or death due to worsening Chronic Thromboembolic Pulmonary Hypertension.~Clinical Worsening was assessed after 12 weeks and 24 weeks, participants experiencing clinical worsening at any time-point are reported."|12 weeks and 24 weeks|All randomized subjects who received at least one dose of study medication.|||Participants|||Count of Participants
2678927|NCT01416636|Primary|Change in 6-minute Walk Test Distance After 24 Weeks|"To determine the effect of subcutaneous Treprostinil sodium on 6-minute walk test distance after 24 weeks in patients with severe non-operable chronic thromboembolic pulmonary hypertension severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension~Time frame of the 6-minute walk test: The 6-minute walk test was conducted at the following visits:~baseline (day 1)~Visit 6 (day 168)~In case of missing values, Last-Observation-Carried-Forward imputation method was used. In such cases values documented at Visit 4 (day84) were used."|Baseline and 24 weeks|All randomized subjects who received at least one dose of study medication.|||m||Standard Deviation|Mean
2678928|NCT01416610|Secondary|Beck Depression Inventory (BDI) Score by Visit|The BDI questionnaire items were scored by generating the sum of the responses to all answered items. Each result was categorized into one of four categories: 0-13= no depression or clinically not significant or in remission; 14-19= mild depression; 20-28= moderate depression; or 29-63= severe depression. Mean scores are presented by visit.|at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months|Participants with a viable score at the given time point|||units on a scale||Standard Deviation|Mean
2678929|NCT01416610|Secondary|Beschwerdeliste (BL) Score by Visit|"The BL questionnaire items were scored by calculating the average response to all answered items. Items can be graded 1=stark (affliction is strong) to 4=gar nicht (not present). The higher the BL score, the less afflictions were present for a participant. Mean scores are presented by visit."|at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months|Participants with a viable score at the given time point|||units on a scale||Standard Deviation|Mean
2678930|NCT01416610|Secondary|Fatigue Severity Scale (FSS) Score by Visit|The Fatigue Severity Scale (FSS) consists of 9 questions, each answered within a range of 1-7, where lower scores indicate less fatigue in everyday life. The FSS score is the mean of the 9 numbers. Mean scores are presented by visit.|at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months|Participants with a viable score at the given time point|||units on a scale||Standard Deviation|Mean
2678931|NCT01416610|Secondary|Short Form Health Survey (SF-36) Scores by Visit|The SF-36 questionnaire items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions of physical functioning, role functioning, bodily pain, general health, vitality, social functioning, and mental health were scored on a scale of 0 (worst) to 100 (best), and health transition was scored on a scale of 0 (worst) to 5 (best). Summary SF-36 scores are reported by category and by visit.|at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months|Participants with a viable score at the given time point|||units on a scale||Standard Deviation|Mean
2678932|NCT01416610|Secondary|Percentage of Participants With Virological Relapse|Virological relapse is defined as no SVR24 in a participant with undetectable HCV RNA at end of treatment who has at least one post-treatment polymerase chain reaction (PCR) result available, using a LOCF approach. Percentage is based on the number of non-missing observations (total).|by end of follow-up, within 3 years, 6 months|Participants who completed treatment|||percentage of participants||95% Confidence Interval|Number
2678933|NCT01416610|Secondary|Percentage of Participants With End of Treatment Response|A participant was considered to have end of treatment response if there was undetectable HCV RNA after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).|at end of treatment, within 3 years, 6 months||||percentage of participants||95% Confidence Interval|Number
2678934|NCT01416610|Secondary|Percentage of Participants With SVR 12|SVR 12 is defined as percentage of participants with undetectable HCV RNA 12 weeks after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).|12 weeks after completing treatment, within 3 years, 6 months||||percentage of participants||95% Confidence Interval|Number
2678935|NCT01416610|Primary|Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24)|SVR24 is defined as percentage of participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment, using a last observation carried forward (LOCF) approach. Percentage is based on the number of non-missing observations (total).|24 weeks after completing treatment, within 3 years, 6 months||||percentage of participants||95% Confidence Interval|Number
2678936|NCT01416584|Other Pre-specified|Entered Methadone Treatment|Did the participant enter methadone treatment at any point in the 6-month treatment period?|6 months|We did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.||||||
2678937|NCT01416584|Other Pre-specified|In Methadone Treatment at End of Treatment|Was each participant in methadone treatment at the end of the 6-month intervention evaluation period?|6 months|We did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.||||||
2678938|NCT01416584|Other Pre-specified|Did Participant Inject Drugs?|Percent of months that participants reported injecting drugs.|6 months|We did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.||||||
2678939|NCT01416584|Other Pre-specified|Went to Shooting Gallery/House or Other Place Where Users go to Shoot-up?|The percent of months that participants reported going to a shooting gallery/hour or other place where users go to shoot-up.|6 months|Due to the very low rate of reports of going to a shooting gallery/house or other place where users go to shoot-up in all groups, we did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.||||||
2678940|NCT01416584|Other Pre-specified|Did Participant Share Needles or Works?|Percent of months that participants reported sharing needles or works.|6 months|Due to the very low rate of reports of sharing needles or works in all groups, we did not analyze this measure. This grant has ended and there is no funding to conduct more analyses.||||||
2678941|NCT01416584|Secondary|Percentage of M,W,F Urine Samples Negative for Opiates|Was each participant's urine sample negative for opiates at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period?|6 months|intent to treat|||percentage of M,W,F urine samples||Full Range|Mean
2678942|NCT01416584|Secondary|Percentage of M,W,F Urine Samples Negative for Cocaine|Was each participant's urine sample negative for cocaine at each of the Monday, Wednesday, Friday urine samples scheduled throughout the intervention evaluation period?|6 months|intent to treat|||percentage of urine samples||Full Range|Mean
2678943|NCT01416584|Primary|Percentage of Monthly Urine Samples Negative for Cocaine|Was the participant's urine sample negative for cocaine at each of the six 30-day assessments scheduled throughout the intervention evaluation period?|6 months|intent to treat|||percentage of cocaine negative||Full Range|Mean
2678944|NCT01416584|Primary|Percentage of Monthly Urine Sample Negative for Opiates|Percentage of urine sample negative for opiates at each of the six 30-day assessments scheduled throughout the intervention evaluation|6 months|Intent to treat|||percentage of opiate negative||Full Range|Mean
2678945|NCT01416584|Primary|Percentage of Months in Methadone Treatment|The percentage of months in which participants were enrolled in methadone treatment during the 6-month intervention evaluation period?|6 months|Intent to treat|||percent of months in methadone treatment||Full Range|Mean
2678946|NCT01416571|Secondary|Number of Subjects With Any and Related Serious Adverse Events (SAEs)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 84 and from Day 0 to Day 385|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Participants|||Count of Participants
2678947|NCT01416571|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an unsolicited AE regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 20 and from Day 0 to Day 84.|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Participants|||Count of Participants
2678948|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIL), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents Total BIL, BIL con/dir, CREA and BUN results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Participants|||Count of Participants
2678958|NCT01416571|Secondary|Duration of Solicited Local Symptoms After Vaccination.|Assessed solicited local symptoms were pain, redness and swelling. Duration was defined as the number of days with any grade of local symptoms.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination, on subjects who experienced the specific symptom.|||days||Inter-Quartile Range|Median
2678949|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents WBC, ALT and AST results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Participants|||Count of Participants
2678950|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents NEU, PLA and RBC results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Participants|||Count of Participants
2678951|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents HBIN, LYM and MON results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Participants|||Count of Participants
2678952|NCT01416571|Secondary|Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.|Assessed biochemical and haematological parameters were alanine aminotransferase (ALT), aspartate aminotransferase (AST), basophils (BAS), blood urea nitrogen (BUN), creatinine (CREA), eosinophils (EOS), haematocrit (HCRIT), haemoglobin (HBIN), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC), total bilirubin (Total BIR), bilirubin conjugated/direct (BIL con/dir). Per parameter, it was assessed whether subjects had laboratory values unknown, below, within or above the normal ranges. This outcome presents BAS, EOS and HCRIT results.|At Day 0 and Day 42|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Participants|||Count of Participants
2678953|NCT01416571|Secondary|Number of Subjects With Potential Immune Mediated Disease (s) (pIMDs).|pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune aetiology.|From Day 0 to Day 84 and from Day 0 to Day 385|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Participants|||Count of Participants
2678954|NCT01416571|Secondary|Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).|MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 385|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Participants|||Count of Participants
2678955|NCT01416571|Secondary|Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).|MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of any MAEs regardless of intensity grade or relationship to vaccination. Grade 3 = event which prevented normal activities Related = event assessed by the investigator as causally related to the study vaccination.|From Day 0 to Day 84|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Participants|||Count of Participants
2678956|NCT01416571|Secondary|Duration of Solicited General Symptoms After Vaccination.|Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, increased sweating and shivering. Duration was defined as the number of days with any grade of general symptoms.|During the 7-day (Days 0-6) post-vaccination period following each dose|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination, on subjects who experienced the specific symptom.|||days||Inter-Quartile Range|Median
2678957|NCT01416571|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were fatigue, gastrointestinal, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination. Any fever was defined as axillary temperature ≥ 38 degrees Celsius (°C). Grade 3 = general symptom that prevented normal activities. Grade 3 fever = fever ≥ 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination.|During the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Participants|||Count of Participants
2678978|NCT01416272|Secondary|Visual Acuity - High Contrast|High contrast visual acuity measured with high ambient illumination (HCHI)|4 visits over 1 year|DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.||||||
2678959|NCT01416571|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of intensity grade. Grade 3 pain = significant pain at rest; prevented normal activities. Grade 3 Redness/Swelling = Redness/Swelling >100 millimeters (mm).|During the 7-day follow-up period (Days 0-6) after any vaccination|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one study vaccination.|||Participants|||Count of Participants
2678960|NCT01416571|Secondary|Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.|MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.|||ratio||95% Confidence Interval|Geometric Mean
2678961|NCT01416571|Secondary|Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer < 1:10 and a post-vaccination reciprocal HI titer (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.|At Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.|||Participants|||Count of Participants
2678962|NCT01416571|Secondary|Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.|At Day 0 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.|||Participants|||Count of Participants
2678963|NCT01416571|Secondary|Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs).|At Day 0 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.|||titers||95% Confidence Interval|Geometric Mean
2678964|NCT01416571|Secondary|Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.|A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.|At Day 0 and Day 182|The analysis was performed on the According-to-Protocol (ATP) cohort for persistence at Day 182, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against the vaccine-homologous H5N1 HA antigen for the blood samples taken at Day 0 and Day 182 were available.|||Participants|||Count of Participants
2678965|NCT01416571|Secondary|Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.|Titers are presented as geometric mean titers (GMTs).|At Day 0 and Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.|||titers||95% Confidence Interval|Geometric Mean
2678966|NCT01416571|Secondary|Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.|A seropositive subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:10.|At Day 0 and Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.|||Participants|||Count of Participants
2678967|NCT01416571|Primary|Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.|A seroprotected subject was defined as a vaccinated subject who had H5N1 reciprocal HI titers ≥ 1:40 against the vaccine-homologous virus.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.|||Participants|||Count of Participants
2678968|NCT01416571|Primary|Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.|MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.|||ratio||95% Confidence Interval|Geometric Mean
2678969|NCT01416571|Primary|Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.|A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer less than (<) 1:10 and a post-vaccination reciprocal HI titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination reciprocal titer against the vaccine virus.|At Day 42|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine doses and for whom the assay results for antibodies against vaccine-homologous H5N1 Hemagglutinin (HA) antigen for the blood samples taken at Day 0, and Day 42 were available.|||Participants|||Count of Participants
2678979|NCT01416272|Secondary|Visual Acuity - Low Contrast|Low contrast visual acuity measured with high ambient illumination (LCHI)|4 visits over 1 year|DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE.||||||
2678970|NCT01416389|Secondary|Pharmacokinetics, Intracycle Accumulation Ration (Ra) of LY2523355|The intracycle accumulation ratio (Ra) is defined as the LY2523355 Cmax on Day 3 of Cycle 1 to the LY2523355 Cmax on Day 1 of Cycle 1 after a 1-hour intravenous infusion of LY2523355 on Day 1 and Day 3 of Cycle 1.|Cycle 1: Day 1 and Day 3|Participants who received 1-dose of LY2523355 on Day 1 and Day 3 of Cycle 1 and who have evaluable pharmacokinetic data to enable estimation of the LY2523355 Cmax on Day 1 and Day 3 of Cycle 1. One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2, and is not included in this analysis.|||unitless ratio||Geometric Coefficient of Variation|Geometric Mean
2678971|NCT01416389|Secondary|Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LSN2546307|Cmax is the maximum plasma concentration of LSN2546307 (metabolite) after a 1-hour intravenous infusion of LY2523355 on Day 1 and Day 3 of Cycle 1.|Cycle 1: Day 1 and Day 3|Participants who received 1 dose of LY2523355 on Day 1 and Day 3 of Cycle 1 and who have evaluable pharmacokinetic data to enable estimation of the LSN2546307 Cmax on Day 1 and Day 3 of Cycle 1.One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2, and is not included in this analysis.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2678972|NCT01416389|Other Pre-specified|Percentage of Deaths on Study Through the Follow-up Period|"The percentage of participants who died through the follow-up period of the study; the cause of death was not captured.~A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module."|Baseline through end of treatment follow-up (up to 423 days)|Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone). One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.|||percentage of participants|||Number
2678973|NCT01416389|Secondary|Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355|Cmax is the maximum plasma concentration of LY2523355 after a 1-hour intravenous infusion of LY2523355 on Day 1 and Day 3 of Cycle 1.|Cycle 1: Day 1 and Day 3|Participants who received 1 dose of LY2523355 on Day 1 and Day 3 of Cycle 1 and who have evaluable pharmacokinetic data to enable estimation of the LY2523355 Cmax on Day 1 and Day 3 of Cycle 1. One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2, and is not included in this analysis.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2678974|NCT01416389|Secondary|Percentage of Participants Achieving a Clinical Benefit (Clinical Benefit Rate)|"Clinical benefit rate is the proportion of participants who achieve a best response of complete response (CR), partial response (PR), or stable disease (SD) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines. CR is a disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. SD is neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as progressive disease, taking as reference the smallest sum diameter since treatment started.~Clinical benefit rate is calculated as a total number of participants with CR, PR, or SD divided by the total number of participants with measurable disease, multiplied by 100."|Baseline to measured progressive disease or date of death from any cause (up to 423 days)|Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone). One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.|||percentage of responders||90% Confidence Interval|Number
2678975|NCT01416389|Secondary|Progression-free Survival (PFS)|Progression-free survival (PFS) is the time from the date of randomization to the first date of progressive disease (PD) or death due to any cause, whichever occurs first. PD is as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines, and is defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). In addition, the sum must have demonstrated an absolute increase of at least 5 millimeter (mm) (the appearance of 1 or more new lesions was considered progression). Kaplan-Meier analysis was performed on the observed distribution of PFS. Participants were censored from analysis for the following reasons: lack of disease assessment, lost to follow-up, and further anticancer therapy started. Median PFS is presented.|Baseline to measured progressive disease or date of death from any cause (up to 423 days)|Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone). The total number of participants censored is 7. One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.|||months||90% Confidence Interval|Median
2678976|NCT01416389|Secondary|Percentage of Participants Achieving an Overall Response (Overall Response Rate)|Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines. CR is a disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100.|Baseline to measured progressive disease or date of death from any cause (up to 423 days)|Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone). One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.|||percentage of responders||90% Confidence Interval|Number
2678977|NCT01416389|Primary|Change in Tumor Size (CTS) From Baseline to the End of Cycle 2|The log ratio of tumor size at Cycle 2 to tumor size at baseline is calculated for each participant, where the tumor size is the sum of the target lesion measurements at each assessment.|Baseline up to end of Cycle 2 (Day 42)|Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone) and who had target lesion measurements at both baseline and the end of Cycle 2. One participant was mistakenly dosed with 6 mg/m^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis.|||log ratio of end of Cycle 2 to baseline||Standard Deviation|Mean
2678981|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in Number of New/Enlarging T2 Lesions|New or enlarging T2 lesions as measured by MRI.|Baseline (Part 1) and Weeks 156 and 204|Summary new/enlarging T2 lesion values are provided in previous Outcome Measure. Due to the nature of self-selected population in an extension trial and sparse data up to Week 204, further tabulations on percentage changes on these endpoints were deemed less meaningful and unnecessary, and the analysis was not done.||||||
2678982|NCT01416181|Secondary|Part 2: Summary of New/Enlarging T2 Lesion Counts|New or enlarging T2 lesions as measured by MRI.|Baseline (Part 1) up to Week 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||lesions||Standard Deviation|Mean
2678983|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in Whole Gray Matter Brain Volume|Whole grey matter brain volume as measured by MRI.|Baseline (Part 1) and Weeks 156 and 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||percentage change||Standard Deviation|Mean
2678984|NCT01416181|Secondary|Part 2: Percentage Change From Week 24 (Part 1) in Whole Brain Volume|Whole brain volume as measured by MRI.|Week 24 (Part 1) and Weeks 156 and 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||percentage change||Standard Deviation|Mean
2678985|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 2) in the WPAI-MS Questionnaire|The WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (percentage of work time missed) 2. Presenteesism (percentage of impairment at work/reduced on-the-job effectiveness) 3. Work productivity loss (WPL; percentage of overall work impairment [absenteeism plus presenteeism]) 4. Activity Impairment (AI; percentage of overall activity impairment). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|Part 2 Baseline (Week 108) and Weeks 156 and 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||percentage change||Standard Deviation|Mean
2678986|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 2) in the Work Productivity and Activity Impairment - Multiple Sclerosis (WPAI-MS) Questionnaire|The WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (percentage of work time missed) 2. Presenteesism (percentage of impairment at work/reduced on-the-job effectiveness) 3. Work productivity loss (percentage of overall work impairment [absenteeism plus presenteeism]) 4. Activity Impairment (percentage of overall activity impairment). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.|Part 2 Baseline (Week 108) and Weeks 156 and 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2) who had an assessment at Baseline and given time point.|||percentage of impairment||Standard Deviation|Mean
2678987|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in the SDMT|SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best).|Baseline (Part 1) and every 4 weeks from Week 108 to Week 204|Actual change from baseline tables are provided in previous Outcome Measure. Due to the nature of self-selected population in an extension trial and sparse data up to Weeks 204 and 252, further tabulations on percentage changes on these endpoints were deemed less meaningful and unnecessary, and the analysis was not done.||||||
2678988|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in the Symbol Digit Modalities Test (SDMT)|SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best).|Baseline (Part 1) and every 4 weeks from Week 108 to Week 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2). Missing values were imputed using last observation carried forward.|||units on a scale||Standard Deviation|Mean
2678989|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in the MSIS-29 Physical Score|The 29-item MSIS-29 is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health. A negative number on change from baseline value indicates an improvement in MSIS-29.|Baseline (Part 1) and Weeks 156, 204|Actual change from baseline tables are provided in previous Outcome Measure. Due to the nature of self-selected population in an extension trial and sparse data on Weeks 204 and 252, further tabulations on percentage changes on these endpoints were deemed less meaningful and unnecessary.||||||
2678990|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in the MSIS-29 Physical Score|The 29-item MSIS-29 is a patient-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a patient's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health. A negative number on change from baseline value indicates an improvement in MSIS-29.|Baseline (Part 1) and Weeks 156 and 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2) who had an assessment at Baseline and given time point.|||units on a scale||Standard Deviation|Mean
2678991|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in the 6MWT|The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.|Baseline (Part 1) and Weeks 156, 204|Actual change from baseline tables are provided in previous Outcome Measure. Due to the nature of self-selected population in an extension trial and sparse data on Weeks 204 and 252, further tabulations on percentage changes on these endpoints were deemed less meaningful and unnecessary.||||||
2680326|NCT01402102|Secondary|Changes in Apo-A1(Apolipoprotein A1)|Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||g/L||Standard Deviation|Mean
2678992|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in the 6-Minute Walk Test (6MWT)|The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.|Baseline (Part 1) and Weeks 156 and 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||meters||Standard Deviation|Mean
2678993|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in EDSS|The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||percentage change||Standard Deviation|Mean
2678994|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in EDSS|The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||units on a scale||Standard Deviation|Mean
2678995|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in 9HPT (Non-Dominant Hand)|The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The two trials for each hand are averaged. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||percentage change||Standard Deviation|Mean
2678996|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in 9HPT (Non-Dominant Hand)|The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The two trials for each hand are averaged. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||seconds||Standard Deviation|Mean
2678997|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in 9HPT (Dominant Hand)|The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The two trials for each hand are averaged. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||percentage change||Standard Deviation|Mean
2678998|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in 9HPT (Dominant Hand)|The 9HPT is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The two trials for each hand are averaged. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||seconds||Standard Deviation|Mean
2678999|NCT01416181|Secondary|Part 2: Percentage Change From Baseline (Part 1) in T25FW|The T25FW is a quantitative mobility and leg function performance test based on a timed 25-foot walk. The participant is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the participant has reached the 25-foot mark. The task is immediately repeated; the score for the T25FW is the average of the two completed trials. Values are presented for the overall group, as well as the CP (defined in the primary outcome measure description above) and NP subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||percentage change||Standard Deviation|Mean
2679020|NCT01416025|Primary|Number of Participants With Treatment Failure|"The primary endpoint of the study will be a binary outcome, called Failure, defined as one of the following: measured at 42 days from initiation of drug administration:~Progression of underlying infection (clinical failure)~Death~Development of a voriconazole-associated SAE: LFTs, Rash, Visual disturbance, Neurologic abnormality (e.g: hallucinations)"|42 days||||participants|||Number
2679578|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Walker|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set|||participants|||Number
2679000|NCT01416181|Secondary|Part 2: Absolute Change From Baseline (Part 1) in T25FW|The T25FW is a quantitative mobility and leg function performance test based on a timed 25-foot walk. The participant is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the participant has reached the 25-foot mark. The task is immediately repeated; the score for the T25FW is the average of the two completed trials. Lower scores on time taken to reach 25 foot mark reflect a better outcome. Values are presented for the overall group, as well as the Confirmed Progressor (CP, defined in the primary outcome measure description above) and Non-Progressor (NP) subgroups.|Baseline (Part 1) and Weeks 156, 204|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2); n=participants who had an assessment at Baseline and given time point.|||seconds||Standard Deviation|Mean
2679001|NCT01416181|Secondary|Part 2: Percentage of Participants With Disability Worsening at 156 Weeks|Percentage of participants with disability worsening at each scheduled efficacy visit in Part 2, defined as one or more of the following: • ≥ 20% worsening from Part 1 baseline in T25FW; • ≥ 20% worsening from Part 1 baseline in 9HPT; • Worsening from Part 1 baseline in EDSS (≥ 1 point increase if Part 1 baseline EDSS ≤ 5.5 or ≥ 0.5 point increase if Part 1 baseline EDSS > 5.5). The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. The T25FW is a quantitative mobility and leg function performance test where the participant is timed while walking for 25 feet. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs. 95% CIs of percentages are based on normal approximation.|Week 156|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment (Part 2).|||percentage of participants||95% Confidence Interval|Number
2679002|NCT01416181|Secondary|Part 1: Percentage of Participants Defined as Confirmed Progressors on EDSS Functional System Scores|"The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist. Participants with confirmed progression of disability in EDSS physical functional system scores will be defined as those who met one of the following criteria:~an increase of ≥ 1 point from baseline system score of ≥ 1 or an increase of ≥ 2 points from baseline system score of 0 in at least 2 physical functional systems, or~an increase of ≥ 2 points from baseline system score of ≥ 1 or an increase of ≥ 3 points from baseline system score of 0 in any 1 physical functional system.~A confirmed progressor was defined as a participant who met the criteria for disability progression at any given visit and at the 6-Month Confirmation Visit. The 95% CIs are based on normal approximation."|Up to 96 weeks|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment.|||percentage of participants||95% Confidence Interval|Number
2679003|NCT01416181|Secondary|Part 1: Percentage Change From Week 24 in Whole Brain Volume at Week 96|Whole brain volume as measured by MRI.|Week 24 and Week 96|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment. Includes those participants with an assessment at Weeks 24 and 96.|||percentage change||Standard Deviation|Mean
2679004|NCT01416181|Secondary|Part 1: Change From Baseline in the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical) Score|The 29-item MSIS-29 is a participant-reported outcome measure to assess the impact of MS on day-to-day life during the past 2 weeks from a participant's perspective; it measures 20 physical items and 9 psychological items. The physical score is generated by summing individual items and then transforming to a scale with a range of 0 to 100, where high scores indicate worse health. A negative number on change from baseline value indicates an improvement in MSIS-29.|Baseline and Week 96|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment. Excludes participants who withdrew prior to 1 year (defined as stopping treatment prior to Week 48) of participation in the study.|||units on a scale||Standard Deviation|Mean
2679005|NCT01416181|Secondary|Part 1: Change From Baseline in Manual Ability Score Based on the ABILHAND Questionnaire|The ABILHAND Questionnaire measures the participant's perceived difficulty in performing everyday manual activities in the last 3 months. The participant completes a 56-item questionnaire by estimating their own difficulty or ease in performing each of 56 activities. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where high scores indicate greater impact on manual ability. A positive number on change from baseline value indicates an improvement in ABILHAND.|Baseline and Week 96|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment. Excludes participants who withdrew prior to 1 year (defined as stopping treatment prior to Week 48) of participation in the study.|||units on a scale||Standard Deviation|Mean
2679006|NCT01416181|Secondary|Part 1: Change From Baseline in the 12-Item MS Walking Scale (MSWS-12)|MSWS-12 is a participant self-assessment of the walking limitations due to MS during the past 2 weeks. It contains 12 items that measure the impact of MS on walking. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where higher scores indicate greater impact on walking. A negative number on change from BL value indicates an improvement in MSWS-12.|Baseline and Week 96|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment. Excludes participants who withdrew prior to 1 year (defined as stopping treatment prior to Week 48) of participation in the study.|||units on a scale||Standard Deviation|Mean
2679007|NCT01416181|Secondary|Part 1: Percentage of Participants With a T25FW Response|T25FW response is defined as any improvement from the best pre-dose T25FW in at least 75% of the scheduled on-treatment visits through Week 96. The T25FW is a quantitative mobility and leg function performance test based on a timed walk over 25 feet. The participant is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the participant has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. The score for the T25FW is the average of the 2 completed trials. The 95% CI of the percentage is based on normal approximation.|Up to 96 weeks|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment. Excludes participants who withdrew prior to 1 year (defined as stopping treatment prior to Week 48) of participation in the study.|||percentage of participants||95% Confidence Interval|Number
2679008|NCT01416181|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|AE: any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. SAE: any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect. An SAE may have also been any other medically important event in the opinion of the Investigator.|218 weeks|Safety population: all participants who were randomized in Part 1 and received at least 1 infusion of study treatment in Part 2.|||participants|||Number
2679009|NCT01416181|Primary|Part 1: Percentage of Participants With Confirmed Progression of Disability in One or More of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), or 9-Hole Peg Test (9HPT)|"Confirmed disability progression, defined as ≥1 of the following criteria (confirmed at a second visit ≥6 months later and at Week 96):~Confirmed progression in EDSS (EDSS score increased from baseline [BL] by ≥1 point if BL EDSS ≤5.5 or by ≥0.5 points if BL EDSS ≥6);~Confirmed progression in T25FW (T25FW increased by ≥20% of the BL walk);~Confirmed progression in 9HPT (9HPT increased by ≥20% of the time taken at BL on either hand and confirmed on the same hand).~The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. The T25FW is a quantitative mobility and leg function performance test where the participant is timed while walking for 25 feet. The 9HPT is a quantitative test of upper extremity function that measures the time it takes to place 9 pegs into 9 holes and then remove the pegs. The 95% confidence interval (CI) of the percentage is based on normal approximation."|Up to 96 weeks (2 years)|Intent to treat population: all participants who were randomized and received at least 1 infusion of study treatment.|||percentage of participants||95% Confidence Interval|Number
2679010|NCT01416155|Secondary|Mean Change From Baseline in the Assessment of Expanded Disability Status Scale (EDSS) up to Week 192|The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.|Day 1 up to Week 192|n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2679011|NCT01416155|Secondary|Adjusted Annualized Relapse Rate|Clinical relapses are defined as new or recurrent neurologic symptoms, not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurological findings upon examination by the neurologist. The annualized relapse rate is calculated overall as the total number of relapses experienced in the study divided by the number of days followed in the study, and the ratio multiplied by 365. Obtained from a Poisson regression model, adjusted for the baseline relapse rate from study 101MS203 (NCT01440101).|Day 1 up to approximately 50 months||||relapses per subject-years|Participants|95% Confidence Interval|Number
2679012|NCT01416155|Primary|Number of Participants With Serum Antibodies to Natalizumab|Negative is defined as negative for antibodies at all post-baseline results. Transient positivity is defined as only 1 positive result. Persistent positivity is defined as 2 positive results separated by at least 6 to 12 weeks.|Day 1 up to approximately 50 months|Immunogenicity population: all participants who had received at least 1 infusion of BG00002, were negative for BG00002 antibodies at baseline and had at least 1 nonmissing post-baseline assessment of antibody status.|||participants|||Number
2679013|NCT01416155|Primary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations Due to AEs|An AE was any untoward medical occurrence that did not necessarily have a causal relationship with this treatment. An SAE was any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigators, placed the subject at immediate risk of death (a life-threatening event); however, this did not include an event that, had it occurred in a more severe form, might have caused death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigators, could have jeopardized the subject or may have required intervention to prevent one of the other outcomes listed in the definition above.|Day 1 through First Follow-Up (12 Weeks After Last Infusion) +/- 7 days. Approximately 62 months|Safety population: all participants who received at least 1 dose of study treatment.|||participants|||Number
2679014|NCT01416142|Secondary|Preference for Test Lens|Proportion of participants preferring the Test lens over their spectacles. Participants changed from Spectacles to PureVision Lenses or PureVision Lenses to spectacles during movie intermission.|During the movie (Visit 2)|All eligible, dispensed subjects|||participants|||Number
2679015|NCT01416142|Primary|Visual Acuity|Visual acuity(VA) measured at the screening visit (all eligible participants) while wearing spectacles and the VA measured at the end of study (Visit 3) 1-Week wearing PureVision2 HD lenses. VA wearing spectacles vs. VA wearing PureVision2 HD Lenses, lower the number the better the VA.|Screening visit (Visit 1) and one week follow-up(Visit 3)|Mean scores are based on the number of eyes with nonmissing logMAR VAs. All eligible, dispensed eyes while wearing spectacles vs. wearing PureVision2 lenses.|||logMAR|Participants|Standard Deviation|Mean
2679016|NCT01416129|Primary|Socket Pressure|Pressure sensors are placed on the skin and measured.|10 minutes after fitting with both sockets||||mm Hg||Standard Deviation|Mean
2679017|NCT01416129|Primary|Quality of Life|Validated surveys will be used to solicit participants' subjective experience and feedback.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.|||||||
2679018|NCT01416129|Primary|Balance and Stability|Balance and stability will be assessed for limits of stability and postural stability.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.|||||||
2679019|NCT01416129|Primary|Gait|Gait will be assessed in terms of biomechanics and spatiotemporal parameters.|Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.|||||||
2679053|NCT01415518|Secondary|Change in COPD Symptoms - Breathing|Change in breathing symptom score (from 0 (none) to 4 (severe)) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period (12 weeks)||||Score from 0 to 4||95% Confidence Interval|Least Squares Mean
2679021|NCT01415986|Secondary|Changes in the Quality of Life (QoL)|The change in the overall score of the University of Washington quality of life questionnaire (UW-QOL). Each of the domain-specific items is scored from 0 (worst quality of life (QOL) to 100 (Best QOL). The composite score is created by averaging the scores.|Within 1 month of enrollment or as scheduled at screening and at 3 and 5 months after treatment.|No data was collected because the participant was lost to follow up.||||||
2679022|NCT01415986|Primary|Local Tumor Response to Interstitial Photodynamic Therapy (I-PDT) With Temoporfin|Longitudinal changes in tumor size (cm) and standardized uptake value (SUV) measured with Positron Emission Tomography - Computed Tomography (PET- CT).|Within 1 month of enrollment or as scheduled at screening and at 3 and 5 months after treatment|No data was collected because the participant was lost to follow up.||||||
2679023|NCT01415960|Secondary|Determination of Leuprolide Tmax|Leuprolide Pharmacokinetic Parameters (PK Population).|84 days||||day||Standard Deviation|Mean
2679024|NCT01415960|Secondary|Safety Endpoints|"The WHO/ECOG, bone pain, urinary pain and urinary symptoms data reported are the most frequent percentage at the assessment time.~The WHO/ECOG performance status was summarized using the 0 to 4 WHO/ECOG performance status scale. (0= fully active, able to carry on all pre-disease performances without restriction).~Bone pain, urinary pain and urinary symptoms were determined using a 10-point scale (1= no pain/symptoms, 10= worst pain/symptom imaginable)."|168 Days|Safety endpoints adverse events (AEs), local tolerability, vital signs, performance status, bone pain, urinary pain, and urinary symptoms, occurrence of hot flushes and clinical laboratory and electrocardiogram (ECG) results.|||percentage of participants|||Number
2679025|NCT01415960|Secondary|Determination of Leuprolide Cmax|Leuprolide Pharmacokinetic Parameters (PK Population).|Cmax1: 0, 1 and 4 hours post-dose on Day 0 and once on Days 2, 14, 28, 56; Cmax2: 0, 1 and 4 hours post-dose on Day 84 and once on Days 86, 112 and 168.||||ng/mL||Standard Deviation|Mean
2679026|NCT01415960|Secondary|Prostate-specific Antigen (PSA) Concentrations|"For purposes of calculating summary statistics, any concentration values Below Limit Quantification (BLQ) were to be assigned ½ the Low Limit Quantification (LLOQ) (LLOQ=0.36). If the calculated mean, median or minimum value at a time point was less than LLOQ, BLQ is presented. In addition, since a high proportion of BLQ values may affect the Standard Deviation (SD); if more than 50% of values were imputed, then no mean or median was calculated for that time point."|168 days||||ng/mL||Standard Deviation|Mean
2679027|NCT01415960|Secondary|Follicle-stimulating Hormone (FSH)|"For purposes of calculating summary statistics, any concentration values Below Limit of Quantification (BLQ) were to be assigned ½ the Low Limit of Quantification (LLOQ) (LLOQ=3.66). If the calculated mean, median or minimum value at a time point was less than LLOQ, BLQ is presented. In addition, since a high proportion of BLQ values may affect the Standard Deviation (SD); if more than 50% of values were imputed, then no mean or median was to be calculated for that time point."|168 days||||mIU/mL||Standard Deviation|Mean
2679028|NCT01415960|Secondary|Determination of Serum Luteinizing Hormone (LH)|"For purposes of calculating summary statistics, any concentration values Below Limit of Quantification (BLQ) were to be assigned ½ the Low Limit of Quantification (LLOQ) (LLOQ=2.00). If the calculated mean, median or minimum value at a time point was less than LLOQ, BLQ is presented. In addition, since a high proportion of BLQ values may affect the Standard Deviation (SD); if more than 50% of values were imputed, then no mean or median was calculated for that time point."|168 days||||mIU/mL||Standard Deviation|Mean
2679029|NCT01415960|Primary|Percentage of Participants Achieving Chemical Castration (Defined as Testosterone Levels ≤ 0.5 ng/mL) at Days 28, 84, and 168.|The primary endpoint was testosterone ≤ 0.5 ng/mL assessed on Days 28, 84, and 168. Thereby, maintenance of castration was to be demonstrated through Day 168 with no missing data at these key time points, unless the missing data were due to an event unrelated to the study drug (ITT patients).|168 days||||percentage of participants||95% Confidence Interval|Number
2679030|NCT01415934|Primary|Proportion of Deaths Within 60 Days of Enrollment.|To determine, among patients with life-limiting illness, if there is a difference in the proportion who die within 60 days after enrollment between patients for whom statins are discontinued vs. patients who are maintained on the medication.|Within 60 days of Subject Enrollment|Intent to treat|||proportion of deaths||90% Confidence Interval|Number
2679031|NCT01415921|Primary|Post Exercise Heart Rate Recovery|Change in heart rate from peak exercise to 1 minute post-exercise (beats per minute)|12 weeks|Heart rate recovery is also measured as beats/min (peak HR at end of exercise – HR 1 min post exercise = HRR).|||beats per minute||Standard Deviation|Mean
2679032|NCT01415921|Primary|Baseline Heart Rate Recovery|Change in peak HR at end of exercise to 1 minute post-exercise (beats per minute)|Baseline|Heart rate recovery is also measured as beats/min (peak HR at end of exercise – HR 1 min post exercise = HRR).|||beats per minute||Standard Deviation|Mean
2679033|NCT01415908|Secondary|Hospital Stay||During the time of hospital stay||||days||Standard Deviation|Mean
2679034|NCT01415908|Secondary|Blood Loss||During the operation, an average of 200 minutes for investigational group and 281.5 minutes for control group||||mls||Standard Deviation|Mean
2679035|NCT01415908|Secondary|Operative Time||Operative time was recorded from skin incision to wound closure||||minutes||Standard Deviation|Mean
2679036|NCT01415908|Secondary|Percent of Subjects Who Had Additional Surgical Procedures/Interventions||24 months||||percentage of participants|||Number
2679037|NCT01415908|Secondary|Success Rate of General Health Status|The Medical Outcomes Study 36-Item Short Form (SF-36) health survey was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The scores for PCS and MCS are between 0 and 100, with higher scores denoting better quality of life. To be classified as a success, the following criteria must be met for SF-36 PCS and MCS, respectively: post-operative score - pre-operative score >= 0. The results are reported as percent of subjects who have SF-36 PCS success, SF-36 MCS success, and overall SF-36 success.|24 months||||percentage of participants|||Number
2679054|NCT01415518|Secondary|Use of Reliever Medication During Day in the Whole Treatment Period|Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period (12 weeks)||||times/day||95% Confidence Interval|Least Squares Mean
2679038|NCT01415908|Secondary|Success Rate of Leg Pain|"Numerical rating scales were used to evaluate leg pain intensity and frequency. Subjects rated their leg pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, subjects recorded their leg pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total leg pain score were the sum of pain intensity and frequency scores. Success rate of leg pain is reported as percent of subjects whose leg pain improvement met: pre-operative score - post-operative score > 0."|24 months||||percentage of participants|||Number
2679039|NCT01415908|Secondary|Success Rate of Back Pain|"Numerical rating scales were used to evaluate back pain intensity and frequency. Subjects rated their back pain intensity on a scale from 0-10, with a score of 0 representing no pain and a score of 10 representing pain as bad as it could be. Similarly, subjects recorded their back pain frequency on a scale from 0-10, with a score of 0 being pain none of the time and a score of 10 being pain all of the time. The total back pain score were the sum of pain intensity and frequency scores. Success rate of back pain is reported as percent of subjects whose back pain improvement met: pre-operative score - post-operative score > 0."|24 months||||percentage of participants|||Number
2679040|NCT01415908|Secondary|Success Rate of Neurological Status|Neurological status was assessed in six sections: motor, sensory, reflexes, straight leg raising, bowel function, and bladder function. Each of the sections had a number of elements. Success rate of neurological status is reported as percent of subjects whose neurological status was maintained or improved in three key neurological assessments—motor, sensory, and deep tendon reflexes.|24 months||||percentage of participants|||Number
2679041|NCT01415908|Secondary|Success Rate of Oswestry Disability Index|ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability). Success rate of Oswestry Disability Index (ODI) is reported as percent of subjects whose ODI score met: pre-operative score - post-operative score ≥ 15.|24 months||||percentage of participants|||Number
2679042|NCT01415908|Secondary|Rate of Fusion Success|"Rate of fusion success is reported as percent of subjects having fusion success. The fusion success was defined radiologically as:~evidence of bridging bone;~no evidence of motion;~no evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface."|24 months|Eight investigational and 3 control subjects were evaluated for fusion success at 24 months.|||percentage of participants|||Number
2679043|NCT01415908|Primary|Rate of Overall Success|"Rate of overall success is reported as percent of subjects who met all of the following criteria:~fusion at all treated levels (e.g., one level for a one level fusion and two levels for a two level fusion);~pain/disability (Oswestry Disability Index) success;~neurological status success;~no serious adverse event classified as implant associated or implant/surgical procedure associated;~no additional surgical procedure classified as a failure."|24 months||||percentage of participants|||Number
2679044|NCT01415583|Primary|Number of Participants With Post-tonsillectomy Bleeding||2 weeks after surgery||||participants||97.5% Confidence Interval|Number
2679045|NCT01415531|Secondary|Trough Seated Systolic Blood Pressure (SBP)|Change from baseline in mean seated trough cuff Systolic Blood Pressure (SBP) at Week 8 as measured by an Omron device. The secondary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.|Change from Baseline to Week 8|641 patients were randomized to receive double-blind treatment. The Safety population consisted of 641 patients who received at least 1 dose of double-blind treatment. The Intent to Treat population (ITT) consisted of 634 patients who had at least 1 postbaseline seated diastolic blood pressure (DBP) assessment|||mm Hg||Standard Deviation|Mean
2679046|NCT01415531|Primary|Trough Seated Diastolic Blood Pressure (DBP)|Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.|Change from Baseline to Week 8|641 patients were randomized to receive double-blind treatment. The Safety population consisted of 641 patients who received at least 1 dose of double-blind treatment. The Intent to Treat population (ITT) consisted of 634 patients who had at least 1 postbaseline seated diastolic blood pressure (DBP) assessment|||mmHG||Standard Deviation|Mean
2679047|NCT01415518|Secondary|Use of Reliever Medication During Night in the Whole Treatment Period|Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the whole treatment period (12 weeks)||||times/day||95% Confidence Interval|Least Squares Mean
2679048|NCT01415518|Secondary|Use of Reliever Medication During Night in the First Week on Treatment|change in the number of inhalations of reliever medication during day from run-in to the first week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the first week on treatment||||times/day||95% Confidence Interval|Least Squares Mean
2679049|NCT01415518|Secondary|Use of Reliever Medication During Night in the Last Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the last week on treatment||||times/day||95% Confidence Interval|Least Squares Mean
2679050|NCT01415518|Secondary|COPD Exacerbations|Severe exacerbations requiring systemic steroids (oral ≥3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms|Whole treatment period (12 weeks)||||exacerbations/12 weeks||95% Confidence Interval|Least Squares Mean
2679051|NCT01415518|Secondary|COPD Symptoms Sputum|Change in sputum symptom score (from 0 (none) to 4 (severe)) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period (12 weeks)||||Score from 0 to 4||95% Confidence Interval|Least Squares Mean
2679052|NCT01415518|Secondary|COPD Symptoms - Cough|Change in cough symptom score (from 0 (none) to 4 (almost constant)) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period (12 weeks)||||Score from 0 to 4||95% Confidence Interval|Least Squares Mean
2679055|NCT01415518|Secondary|Use of Reliever Medication During Day in the First Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in to the first week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the first week on treatment||||times/day||95% Confidence Interval|Least Squares Mean
2679056|NCT01415518|Secondary|Use of Reliever Medication During Day in the Last Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in to the last week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment||||times/day||95% Confidence Interval|Least Squares Mean
2679057|NCT01415518|Secondary|Post-dose PEF in Whole Treatment Period|Change in post-dose morning PEF at 5 minutes from run-period to whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in whole treatment period (12 weeks)||||L/min||95% Confidence Interval|Least Squares Mean
2679058|NCT01415518|Secondary|Post-dose PEF in First Week of Treatment|Change in post-dose morning PEF at 5 minutes from run-in period to first week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurments measured at 5 minutes after inhalation of study drug in the first week of treatment||||L/min||95% Confidence Interval|Least Squares Mean
2679059|NCT01415518|Secondary|Post-dose PEF in Last Week of Treatment|Change in post-dose morning PEF at 5 minutes from run-period to last week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the last week of treatment||||L/min||95% Confidence Interval|Least Squares Mean
2679060|NCT01415518|Secondary|Pre-dose PEF in Whole Treatment Period|Change in pre-dose morning PEF from run-in period to whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in whole treatment period (12 weeks)||||L/min||95% Confidence Interval|Least Squares Mean
2679061|NCT01415518|Secondary|Pre-dose PEF in First Week of Treatment|Change in pre-dose morning PEF from run-in period to first week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurments measured before inhalation of study drug in the first week of treatment||||L/min||95% Confidence Interval|Least Squares Mean
2679062|NCT01415518|Secondary|Pre-dose PEF in Last Week of Treatment|Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to last week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the last week of treatment||||L/min||95% Confidence Interval|Least Squares Mean
2679063|NCT01415518|Secondary|Post-dose IC at 60 Minutes|Ratio of post-dose IC at 60 minutes to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)||||Ratio||95% Confidence Interval|Geometric Mean
2679064|NCT01415518|Secondary|Pre-dose IC|Ratio of pre-dose IC (Inspiratory Capacity) to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)||||Ratio||95% Confidence Interval|Geometric Mean
2679065|NCT01415518|Secondary|Post-dose FVC at 60 Minutes|Ratio of post-dose FVC at 60 minutes to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)||||Ratio||95% Confidence Interval|Geometric Mean
2679066|NCT01415518|Secondary|Post-dose FVC at 5 Minutes|Ratio of post-dose FVC at 5 minutes to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 5 minutes after inhalation of study drug at weeks 0, 1, 6, 12)||||Ratio||95% Confidence Interval|Geometric Mean
2679067|NCT01415518|Secondary|Pre-dose FVC|Ratio of pre-dose FVC (Forced Vital Capacity) to baseline|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)||||Ratio||95% Confidence Interval|Geometric Mean
2679068|NCT01415518|Secondary|Post-dose FEV1 at 60 Minutes|Ratio of post-dose FEV1 at 60 minutes to baseline value|Baseline (meaured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS|||Ratio||95% Confidence Interval|Geometric Mean
2679069|NCT01415518|Secondary|Post-dose FEV1 at 5 Minutes|Ratio of post-dose FEV1 at 5 minutes to baseline value|Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug|FAS|||Ratio||95% Confidence Interval|Geometric Mean
2679070|NCT01415518|Primary|Pre-dose FEV1|Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value|Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug|FAS|||Ratio||95% Confidence Interval|Geometric Mean
2679071|NCT01415453|Primary|Phosphene Perception in Response to Ultrasound Pulse.|The investigators will test the hypothesis that compression of retinal nerves by ultrasound force will cause perception of light (phosphenes) in blind subjects lacking functioning photoreceptors (retinitis pigmentosa). With each of two 5 msec ARFI exposures, if the subject either perceived the spark of light (phosphene), then it was documented as a positive response; if they did not, it was marked as a negative response.|Subjects will undergo a single examination of approximately 15 minute duration during which they will report perception of phosphenes during ultrasound exposure.|Only one subject was examined.|||participants|||Number
2679072|NCT01415440|Primary|Brain Structure Volume|Brain structure volume measured in mm^3|12 weeks|ADHD participants who completed 12 weeks of treatment.|||mm^3||Standard Deviation|Mean
2679073|NCT01415427|Secondary|Change From Baseline in Urine Keratan Sulfate - MPP|Efficacy was assessed by changes from baseline in urine keratan sulfate (normalized to urine creatinine.)|Baseline to week 168|MPP- modified per-protocol population, define as the ITT(intent to treat) after removing patients who had orthosurgery in first 120 weeks or <96 doses in first 120 weeks|||ug/mg||Standard Deviation|Mean
2679101|NCT01414413|Secondary|Adherence to ART|Comparison between study arms of the proportion of HIV-positive participants who are adherent to ART during the 1-year study period|First 6-months following availability of home-based HIV testing|||||||
2679074|NCT01415427|Secondary|Change From Baseline in Urine Keratan Sulfate - ITT|Efficacy was assessed by changes from baseline in urine keratan sulfate (normalized to urine creatinine.)|Baseline to week 168|ITT-intent-to-treat population, defined as all patients enrolled in the study who received patient IDs regardless of whether they received study drug or not|||ug/mg||Standard Deviation|Mean
2679075|NCT01415427|Secondary|Change From Baseline in 3-minute Stair Climb Test - MPP|Efficacy was assessed by changes from baseline in 3-minute stair climb test.|Baseline to week 168|MPP- modified per-protocol population, define as the ITT(intent to treat) after removing patients who had orthosurgery in first 120 weeks or <96 doses in first 120 weeks|||stairs/min||Standard Deviation|Mean
2679076|NCT01415427|Secondary|Change From Baseline in 3-minute Stair Climb Test - ITT|Efficacy was assessed by changes from baseline in 3-minute stair climb test.|Baseline to week 168|ITT-intent-to-treat population, defined as all patients enrolled in the study who received patient IDs regardless of whether they received study drug or not|||stairs/min||Standard Deviation|Mean
2679077|NCT01415427|Primary|Change From Baseline in 6-minute Walk (6MW) Test - MPP|Efficacy was assessed by changes from baseline in 6-minute walk test|Baseline to week 168|MPP- modified per-protocol population, define as the ITT(intent to treat) after removing patients who had orthosurgery in first 120 weeks or <96 doses in first 120 weeks.|||meters||Standard Deviation|Mean
2679078|NCT01415427|Primary|Change From Baseline in 6-minute Walk (6MW) Test - ITT|Efficacy was assessed by changes from baseline in 6-minute walk test|Baseline to week 168|ITT-intent-to-treat population, defined as all patients enrolled in the study who received patient IDs regardless of whether they received study drug or not.|||meters||Standard Deviation|Mean
2679079|NCT01415401|Secondary|Percentage of Subjects Who Reach Target IOP (≤ 18 mmHg)|IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Week 8|This analysis population includes all subjects who received study medication, completed all study visits, and satisfied inclusion/exclusion criteria. In addition, no imputation methods were employed; therefore only efficacy measurements available at each visit and time point were analyzed.|||percentage of participants|||Number
2679080|NCT01415401|Primary|Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline)|IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.|Baseline, Week 8|This analysis population includes all subjects who received study medication and had at least one on-therapy study visit. Last observation carried forward (LOCF) was used.|||mmHg||Standard Deviation|Mean
2679081|NCT01415349|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for SSP-002358|Area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Assessed over 48 hours post-dose|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Subjects who vomited or experienced significant diarrhea between dosing and 10 hours post-dose were excluded from the pharmacokinetic descriptive statistics and statistical analysis.|||ng*h/ml||Standard Deviation|Mean
2679082|NCT01415349|Primary|Maximum Plasma Concentration (Cmax) for SSP-002358|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over 48 hours post-dose|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Subjects who vomited or experienced significant diarrhea between dosing and 10 hours post-dose were excluded from the pharmacokinetic descriptive statistics and statistical analysis.|||ng/ml||Standard Deviation|Mean
2679083|NCT01415232|Primary|Correlation Between Actual Epidural Needle Depth (ND) and Estimated Epidural Depth (Est-D)|Measured using the Pearson correlation coefficient between actual epidural needle depth (ND) and epidural depth as estimated by the epidural depth equation (EQ-US) followed by ultrasound (longitudinal and transverse planes) measurement.|at the time of labor epidural catheter insertion (an average of 5 minutes for ultrasound visualization)|per protocol|||correlation coefficient||95% Confidence Interval|Number
2679084|NCT01414855|Secondary|Pharmacodynamics: Peripheral Blood CD19-positive B-cell Count||Up to approximately 24 months|||||||
2679085|NCT01414855|Secondary|Pharmacokinetics: Area Under the Concentration-Time Curve 7 Day (AUC7day)|Blood was collected for PK parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in in day times micrograms per milliliter (day*μg/mL).|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.|||day*μg/mL||Standard Deviation|Mean
2679086|NCT01414855|Secondary|Pharmacokinetics: Volume of Distribution (V) for Obinutuzumab|V is the apparent volume in which a drug is distributed in the body. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters (mL).|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.|||mL||Standard Deviation|Mean
2679087|NCT01414855|Secondary|Pharmacokinetics: Clearance (Cl) for Obinutuzumab|Cl is the volume of serum cleared of the drug per unit of time. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in milliliters/day (mL/day).|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.|||mL/day||Standard Deviation|Mean
2679579|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Able to Walk Without Assistance|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set|||participants|||Number
2679088|NCT01414855|Secondary|Pharmacokinetics: Terminal Half-Life (t1/2) for Obinutuzumab|T1/2 is the time required for the concentration of the drug to reach half of its original value. Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in days|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.|||days||Standard Deviation|Mean
2679089|NCT01414855|Secondary|Pharmacokinetics (PK): Maximum Concentration Observed (Cmax) for Obinutuzumab|Blood was collected for PK Parameters. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).|Cycle 1 Day 1 pre and post dose, Days 3,5, Day 8 pre and post-dose, Day 15 pre-dose. Cycle 8 Day 1 pre and post-dose, Days 5,8,12|PK-Evaluable included all participants with viable PK data for analysis.|||μg/mL||Standard Deviation|Mean
2679090|NCT01414855|Secondary|Number of Participants With Grade 3 to 4 Infusion-Related (IRR) Adverse Events (AE) in Participants Receiving Shorter Duration Infusion (SDI)|SDI 120 is a shorter duration infusion of 120 minutes and SDI 90 is shorter duration infusion of 90 minutes. Grade 3 IRR AE: Prolonged (e.g., not rapidly responsive to symptomatic medication and/or brief interruption of infusion); recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae. Grade 4 IRR AE: Life-threatening consequences; urgent intervention indicated.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|Participants from the Safety population, all randomized participants who received at least 1 dose of study drug, who received shorter duration infusions.|||participants|||Number
2679091|NCT01414855|Secondary|Percentage of Participants With Adverse Events as a Measure of Safety|An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug or other protocol-imposed intervention. Preexisting conditions that worsened during the study were reported as adverse events.|From the first dose of study treatment to end of study (up to 5 years 4 months)|Safety population included all randomized participants who received study drug.|||percentage of participants|||Number
2679092|NCT01414855|Secondary|Duration of Response (DOR)|DOR is defined as first occurrence of documented response (CR or PR) until the first occurrence of relapse or progression or death of any cause. CR: disappearance of all evidence of disease. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.|From the response assessment to relapse, progression, or death (up to 64 months)|All participants with data available. Participants who had not progressed, relapsed, or died at the time of analysis were censored for duration of response at the date of the last valid response assessment.|||months||Full Range|Median
2679093|NCT01414855|Secondary|Progression-Free Survival (PFS) as Assessed by the Investigator|PFS was defined as the time from the date of the first dose of study treatment until the date of disease progression, relapse, or death from any cause.|From the first dose of study treatment to PFS assessment (up to 64 months)|All participants. Patients who had not progressed, relapsed or died at the time of analysis were censored on the date of last valid disease assessment. If no tumor assessments were performed after the baseline visit, the patient was censored for PFS at the date after the first dose of study treatments.|||months||95% Confidence Interval|Median
2679094|NCT01414855|Secondary|Overall Response Rate (ORR) as Assessed by the IRF at the End of Treatment|Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|All participants|||percentage of participants||95% Confidence Interval|Number
2679095|NCT01414855|Secondary|Complete Response (CR) Rate as Assessed by the Independent Review Facility (IRF) at the End of Treatment|Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the IRF using CT scans, PET scans and pertinent clinical information. CR is the disappearance of all evidence of disease.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|All participants.|||percentage of participants||95% Confidence Interval|Number
2679096|NCT01414855|Primary|Overall Response Rate (ORR) as Assessed by the Investigator at the End of Treatment|Overall response rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, FDG-PET and computed tomography (CT). CR is the disappearance of all evidence of disease. PR is at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|All participants|||percentage of participants||95% Confidence Interval|Number
2679097|NCT01414855|Primary|Complete Response (CR) Rate as Assessed by the Investigator at the End of Treatment|Complete response rate is defined as the percentage of participants with Complete Response (CR) according to the Revised Response Criteria for Malignant Lymphoma (Cheson et al., 2007). Disease response was evaluated by the investigator using regular clinical and laboratory examinations, fluorodeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT). CR is the disappearance of all evidence of disease.|From the first dose of study treatment to end of treatment response assessment (approximately 228 to 258 days)|All participants.|||percentage of participants||95% Confidence Interval|Number
2679098|NCT01414634|Primary|Number of Adverse Events||3 months after treatment||||Number of AE|||Number
2679099|NCT01414634|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability||12 months|||||||
2679100|NCT01414413|Secondary|Adult Mortality|Comparison between study arms of non-traumatic and HIV-related adult (15-49) mortality rates during the first 6 months of the HIV-testing intervention|The first 6-months following availability of home-based HIV testing|||||||
2679104|NCT01414413|Secondary|Uptake of Home-based HIV Testing|Comparison between study arms of the proportion of all resident adults who request HIV testing (either as standard HTC or as supervised HIV self-testing) from the resident community counsellor during the first year of the study.|The first 6-months following home assessment and initiation of ART being made available||||participants|||Number
2679105|NCT01414413|Primary|ART Initiation|Comparison between study arms of the proportion of all resident adults (per capita, and irrespective of HIV status or participation in home-based HIV testing intervention) who initiate ART during the first 6 months of the home-based HIV-testing intervention.|First six months following introduction of home-based HIV testing||||participants|||Number
2679106|NCT01414257|Secondary|Clinical Efficacy Rate|"Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assesable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of methotrexate was assessed as effective or ineffective by the investigator. The assessment was based on the baseline condition of disease control and degree of alleviation from baseline in clinical symptoms and laboratory data."|24 Weeks|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (clinical efficacy rate) at least once. Participants with observed effectiveness data were included in table.|||Percentage of Participants||95% Confidence Interval|Number
2679107|NCT01414257|Secondary|Number of Participants With Treatment Related Pre-specified Important Serious Adverse Events|Pre-specified important adverse events were 1) Interstitial pneumonia, 2) Pulmonary fibrosis, 3) Hepatic impairment, 4) Renal impairment, 5) Hematopoietic disorder, 6) Infection, and 7) Lymphoma. A treatment-related adverse event was any untoward medical occurrence attributed to methotrexate in a participant who received methotrexate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to methotrexate was assessed by the investigator.|24 Weeks|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received methotrexate at least once.|||Participants|||Number
2679108|NCT01414257|Secondary|Number of Participants With Treatment-Related Serious Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to methotrexate in a participant who received methotrexate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to methotrexate was assessed by the investigator.|24 Weeks|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received methotrexate at least once.|||Participants|||Number
2679109|NCT01414257|Primary|Change From Baseline in Disease Activity Score (DAS28)-4CRP|Disease activity score based on 28-joint count and C-reactive protein (4 variables) (DAS28-4 [CRP]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, C-reactive protein (CRP, mg/dL) and VAS of general health. Mean change from baseline in the DAS28-4 (CRP) at Week 24 is calculated. The total scale range can not be specified.|Baseline and 24 Weeks|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (CRP) at least once. Participants with observed change in DAS28-4 (CRP) were included in table.|||Score||Standard Deviation|Mean
2679110|NCT01414257|Primary|Change From Baseline in Disease Activity Score (DAS28)-4ESR|Disease activity score based on 28-joint count and erythrocyte sedimentation rate (4 variables) (DAS28-4 [ESR]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, ESR (mm/hour) and visual analogue scale (VAS) of general health assessed by participant or investigator. Mean change from baseline in the DAS28-4 (ESR) at Week 24 is calculated. The total scale range can not be specified.|Baseline and 24 Weeks|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (ESR) at least once. Participants with observed change in DAS28-4(ESR) were included in table.|||Score||Standard Deviation|Mean
2679111|NCT01414257|Primary|Disease Activity Score (DAS28)-4CRP|Disease activity score based on 28-joint count and C-reactive protein (4 variables) (DAS28-4 [CRP]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, C-reactive protein (CRP, mg/dL) and VAS of general health. The total scale range of DAS28-4 (ESR) , minimum is 0.0 and maximum can not be specified. DAS28-4 (CRP) >4.1 indicated high disease activity, ≥2.7 to 4.1 indicated moderate disease activity, <2.7 indicated low disease activity, and <2.3 indicated remission.|Baseline and 24 Weeks|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (CRP) at least once. Participants with observed DAS28-4(CRP) were included in table.|||Score||Standard Deviation|Mean
2679112|NCT01414257|Primary|Disease Activity Score (DAS28)-4ESR|Disease activity score based on 28-joint count and erythrocyte sedimentation rate (4 variables) (DAS28-4 [ESR]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, ESR (mm/hour) and visual analogue scale (VAS) of general health assessed by participant or investigator. Higher score indicated more disease activity. The total scale range of DAS28-4 (ESR) , minimum is 0.0 and maximum can not be specified. DAS28-4 (ESR) >5.1 indicated high disease activity, ?3.2 to ?5.1 indicated moderate disease activity, <3.2 indicated low disease activity, and <2.6 indicated remission.|Baseline and 24 Weeks|The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (ESR) at least once. Participants with observed DAS28-4(ESR) were included in table.|||Score||Standard Deviation|Mean
2679113|NCT01414257|Primary|Number of Participants With Treatment-Related Adverse Events|A treatment-related adverse event was any untoward medical occurrence attributed to methotrexate in a participant who received methotrexate.|24 Weeks|The safety analysis set comprised of participants who satisfied the inclusion criteria and had received methotrexate at least once.|||Participants|||Number
2679114|NCT01414244|Secondary|Stool Consistency|Bristol Stool Scale The Bristol Stool Scale characterizes stool characteristics and ranges from a minimum score of 1 with depicts hard or constipated stool to a maximum score of 7 which is watery or diarrheal stools. In this trial, stool that is less than 7 is better and depicts a good outcome.|Baseline and 8 weeks following therapy||||units on a scale (1-7)||Standard Deviation|Mean
2679116|NCT01414244|Secondary|Intestinal Permeability|The secondary outcome measure will be a change in intestinal permeability from baseline to 8 weeks at the conclusion of therapy. Intestinal permeability is measured by the urinary lactulose/mannitol ratio following ingestion of a solution of lactulose and mannitol.|baseline and 8 weeks following therapy||||lactulose/mannitol (L/M)||Standard Deviation|Mean
2679117|NCT01414244|Primary|Change in the Irritable Bowel Symptom Severity Scale|The primary outcome measure will be a change in the Irritable Bowel Symptom Severity Scale (IBS-SS) from baseline to 8 weeks at the conclusion of therapy. The IBS-SS scale ranges from 0 to 500 (worst). A decrease in 50 or greater in the IBS-SS is considered a positive response.|baseline and 8 weeks following therapy||||units on a scale||Standard Deviation|Mean
2679118|NCT01414205|Secondary|Pharmacodynamics: Number of Participants With Peripheral Blood B-cell Recovery|Blood was sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry. B-cell recovery was defined as a CD19 result ≥ 0.07 × 10^9/L, where CD19 was previously depleted. B-cell recovery was only considered possible following the last dose of study treatment. The number of participants with B-cell recovery from End of Treatment to 6 months of Follow-up is reported in two categories: Recovery with Progressive Disease (PD) [PD before B-cell recovery or PD within 45 days after recovery] or Recovery without PD. PD required one of the following: 50% increase in the absolute number of circulating lymphocytes, Appearance of new palpable lymph nodes, 50% increase in the longest diameter of any previous site of lymphadenopathy, 50% increase in the enlargement of the liver and/or spleen or Transformation to a more aggressive histology.|Up to 4 years, 5 months|Participants from the Safety Evaluable Population, all randomized participants who received at least one dose of study drug, with B-Cell depletion.|||Participants|||Number
2679119|NCT01414205|Secondary|Pharmacodynamics: Number of Participants With Peripheral Blood B-cell Depletion|Blood was sent to a central laboratory for the evaluation of cluster of differentiation 19 (CD19) by flow cytometry. B-cell depletion was defined as a CD19 result < 0.07 × 10^9/L after at least one dose of study drug has been administered.|Up to 4 years, 5 months|Participants from the Safety Evaluable Population, all randomized participants who received at least one dose of study drug, who had data available for this outcome measure.|||Participants|||Number
2679120|NCT01414205|Secondary|PK: Serum Concentrations of Obinutuzumab (Follow-Up Visits)|Blood serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).|Months 3, 6, 9, and 12|All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.|||μg/mL||Standard Deviation|Mean
2679121|NCT01414205|Secondary|PK Parameter: Terminal Half-Life (t1/2)|Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). T1/2 was reported in Days.|Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)|All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.|||Days||Geometric Coefficient of Variation|Geometric Mean
2679122|NCT01414205|Secondary|PK Parameter: Volume of Distribution at Steady State (Vss)|Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). Vss is reported in liters.|Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)|All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2679123|NCT01414205|Secondary|PK Parameter: Clearance at Steady State (CLss)|Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA). CLss is reported in milliliters per day (mL/day).|Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)|All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.|||mL/day||Geometric Coefficient of Variation|Geometric Mean
2679124|NCT01414205|Secondary|PK Parameter: Area Under the Serum Concentration-Time Curve Between Dosing Interval Tau (AUCt )|Blood was collected for PK Parameters before and after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in day times micrograms per milliliter (day*μg/mL).|Day 148 (pre-infusion, at end of infusion, 5, 8 and 12 days after start of infusion)|All randomized participants who received study drug with PK data available for analysis. Participants with insufficient data points for PK estimation were excluded.|||day*μg/mL||Geometric Coefficient of Variation|Geometric Mean
2679125|NCT01414205|Secondary|PK Parameter: Maximum Serum Concentration (Cmax)|Blood was collected for Pharmacokinetic (PK) Parameter Cmax after dose administration on Day 1 of Cycle 8. Serum samples were sent to a central lab and were analyzed for obinutuzumab using a validated enzyme-linked immunosorbent assay (ELISA) measured in micrograms per milliliter (μg/mL).|Day 148 (at end of infusion)|All randomized participants who received study drug with PK data available for analysis.|||μg/mL||Geometric Coefficient of Variation|Geometric Mean
2679126|NCT01414205|Secondary|Percentage of Participants With Adverse Events Leading to Study Discontinuation|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution.|Up to 4 years, 5 months|Safety population included all randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2679127|NCT01414205|Secondary|Percentage of Participants With Adverse Events of Interest|Adverse Events of interest for this study were: serious infusion related reactions during or within 24 hours of infusion, serious neutropenia, serious infection, tumor lysis syndrome and Hepatitis B reactivation.|Up to 4 years, 5 months|Safety population included all randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2679580|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Saw Their Physical Therapist|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set|||participants|||Number
2679128|NCT01414205|Secondary|Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution. A SAE was any AE that was one of the following: fatal, life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the investigational product or considered a significant medical event by the investigator. Additional information about AEs can be found in the Adverse Event Section.|Up to 4 years, 5 months|Safety population included all randomized participants who received at least 1 dose of study drug.|||Percentage of participants|||Number
2679129|NCT01414205|Secondary|Number of Participants Surviving at End-of-Study||Up to 4 years, 5 months|Intent-to-treat population included all randomized participants.|||Participants|||Number
2679130|NCT01414205|Secondary|Duration of Response||Up to 4 years, 5 months|||||||
2679131|NCT01414205|Secondary|Progression-free Survival (PFS)|PFS was defined as the time from the randomization to the first occurrence of progression or death, whichever occurred first.|Up to 4 years, 5 months|Intent-to-treat population included all randomized participants.|||Months||95% Confidence Interval|Median
2679132|NCT01414205|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with complete response (CR), CR with incomplete marrow recovery (CRi) or partial response (PR) as assessed by the investigator according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines two months after last treatment. CR required: blood lymphocytes < 4 x 10^9/Liter (L), absence of lymphadenopathy (≤ 1.5 centimeter (cm) in long axis by Computed Tomography), no hepatomegaly or splenomegaly, absence of disease, Neutrophils > 1.5 x 10^9/L, Platelets > 100 x 10^9/L, Hemoglobin >11 g/dL, bone marrow normal and lymphoid nodules absent. CRi was CR with incomplete marrow recovery. PR required: 50% decrease in peripheral blood lymphocyte count, 50% reduction in lymphadenopathy, 50% reduction of liver and/or spleen enlargement if enlarged at baseline, Neutrophils > 1.5 x 10^9/L or > 50% of pretreatment value, Platelets > 100 x 10^9/L or 50% of pretreatment value and Hemoglobin > 11 g/dL or > 50% of pretreatment value.|Week 32|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
2679133|NCT01414192|Secondary|Mortality Rate|The number of participants who died from any cause was recorded. The number of deaths was then extrapolated to produce the number of deaths per 100,000 patient-years.|up to 48 months|All enrolled participants with available data.|||Deaths per 100,000 patient-years||95% Confidence Interval|Number
2679134|NCT01414192|Secondary|Percentage of Participants With at Least 1 Discontinuation of Study Drug|The percentage of participants who stopped study drug at least once during the study period was recorded and summarized.|up to 48 months|All enrolled participants with available data.|||Percentage of Participants|||Number
2679135|NCT01414192|Secondary|Percentage of Participants Who Continued Treatment for 12, 24, 36, and 48 Months|Participants' data reviewed and the number of participants who had continued treatment for 12, 24, 36, and 48 months was recorded.|up to 48 months|All enrolled participants with available data. The ezetimibe monotherapy with or without previous lipid-lowering treatment groups were combined for this outcome.|||Percentage of Participants|||Number
2679136|NCT01414192|Secondary|Percentage of Participants With CV Risk Factors|Enrolled participants' data were reviewed for presence of CV risk factors that included smoking, alcohol & substance abuse, high blood pressure, Type 1 and Type 2 diabetes mellitus, cholesterol level, hypertriglyceridemia, body mass index, cardiovascular disease history, family history of early cardiovascular disease. The sum of all risk factors was tabulated for each participant and totals were summarized by group.|At enrollment (baseline)|All enrolled participants with available data|||Percentage of Participants|||Number
2679137|NCT01414192|Secondary|Percentage Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 12 Months|LDL-C levels at baseline and after 12 months of treatment were compared and the percentage change was recorded. In the model, it is assumed that the 5th and 95th percentiles represent the minimum and maximum effect of treatment, respectively.|Baseline and Month 12|All participants with available data for endpoint. The ezetimibe plus statin and ezetimibe/simvastatin arms were combined for this outcome.|||Percentage Change||Full Range|Mean
2679138|NCT01414192|Primary|Rate of Cardiovascular (CV) Events|Number of participants who experienced myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, revascularization procedure, fatal stroke, and/or sudden death was recorded. The number of events was divided by the total number of patient-years calculated for each treatment group to produce the rate of CV events per 1000 patient years.|up to 48 months|All participants with available data for endpoint.|||Events per 1000 patient-years||95% Confidence Interval|Number
2679139|NCT01414166|Secondary|Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) at Week 16|The percentage change from baseline in participants' Apo A-I was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.||||||
2679140|NCT01414166|Secondary|Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16|The percentage change from baseline in participants' Apo B was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.||||||
2679141|NCT01414166|Secondary|Percent Change From Baseline in Lipoprotein(a) (LP[a]) at Week 16|The pecentage change from baseline in participants LP(a) was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.||||||
2679142|NCT01414166|Secondary|Percent Change From Baseline in the Ratio of Total Cholesterol (TC) to HDL-C at Week 16|The percentage change from baseline in the ratio of TC to HDL-C was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.||||||
2679143|NCT01414166|Secondary|Percent Change From Baseline in Non-HDL-C at Week 16|The percentage change from baseline in participants' non-HDL-C was to be calculated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.||||||
2679144|NCT01414166|Secondary|Percent Change From Baseline in Triglycerides (TG) at Week 16|The percentage change from baseline in participants' TG level was to be evaluated at study Week 16.|Baseline and Week 16|Due to early study termination, this efficacy endpoint was not analyzed.||||||
2679147|NCT01414166|Primary|Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Averaged Across Week 12 and Week 16|The percentage change from baseline in the participants' LDL-C was to be evaluated and averaged across treatment Week 12 and Week 16.|Baseline and Weeks 12 to 16|Due to early study termination, this efficacy endpoint was not analyzed.||||||
2679148|NCT01414153|Secondary|Proportion of Subjects With Adverse Events.||Baseline to Day 120||||percentage of subjects|||Number
2679149|NCT01414153|Secondary|Proportion of Subjects With ETDRS BCVA of 20/40 or Better.|Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly. 20/40 Snellen corresponds to a range of 69-73 letters by ETDRS.|Baseline to Day 120||||percentage of subjects||80% Confidence Interval|Number
2679150|NCT01414153|Secondary|Proportion of Subjects Losing 3 Lines or More in ETDRS BCVA.|Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly. One line is equivalent to 5 letters, so a loss of 3 lines is a loss of 15 letters.|Baseline to Day 120||||percentage of subjects||80% Confidence Interval|Number
2679151|NCT01414153|Secondary|Proportion of Subjects Gaining Greater Than or Equal to 0, 5, 10 and 15 Letters on the ETDRS Chart.|Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly.|Baseline to Day 120||||percentage of subjects||80% Confidence Interval|Number
2679152|NCT01414153|Secondary|Mean Change in CNV Lesion Area as Determined by Fluorescein Angiography (FA).||Baseline to Day 120|ITT population|||mm^2||Standard Error|Least Squares Mean
2679153|NCT01414153|Secondary|Mean Change in Central Subfield Retinal Thickness||Baseline to Day 120|ITT population|||μM||Standard Error|Least Squares Mean
2679154|NCT01414153|Primary|Mean Change in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS)|Visual function was assessed using the ETDRS protocol, for which numerical scores range from 0 to 100 (roughly equivalent to 20/10 vision as measured by Snellen). A higher score represents better functioning. A positive number represents an increase in number of letters read correctly.|Baseline to Day 120|Intent-to-treat (ITT) Population|||letters||Standard Deviation|Least Squares Mean
2679155|NCT01414114|Secondary|Percent Change From Baseline in Phosphorus During the Efficacy Period|Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.|Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)|Modified intent-to-treat population with available data at both time points|||percent change||Standard Deviation|Mean
2679156|NCT01414114|Secondary|Percent Change From Baseline in Corrected Calcium During the Efficacy Period|Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.|Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)|Modified intent-to-treat population with available data at both time points|||percent change||Standard Deviation|Mean
2679157|NCT01414114|Secondary|Percentage of Participants With PTH ≤ 300 pg/mL During the Efficacy Period|The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.|The efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)|Modified intent-to-treat population with available data|||percentage of participants||95% Confidence Interval|Number
2679158|NCT01414114|Secondary|Percentage of Participants With ≥ 30% Reduction in PTH From Baseline During the Efficacy Period|The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.|Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)|Modified intent-to-treat population with available data|||percentage of participants||95% Confidence Interval|Number
2679159|NCT01414114|Primary|Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period|Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period.|Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)|The modified intent-to-treat population (all participants who were randomized and received treatment) with available data at both time points.|||percent change||Standard Deviation|Mean
2679160|NCT01414036|Secondary|Use of Other Tobacco Treatment Support|self-report of all tobacco treatment support received, including support from non-study sources, including the internet, during the study period.|3 months|14 out of the 23 in control group completed 3 month survey and 19 out of 24 in patient navigation group completed the 3 month survey.|||participant|||Number
2679161|NCT01414036|Secondary|Stage of Change With Regard to Smoking Cessation|Stage of change is assessed at baseline and 3 months. Three months after study entry, 7 of patient navigation-intervention participants who had initially said that they did not have a time frame in mind for quitting reported that they now had a time frame in mind for quitting, relative to 1 of ETC-control participants.|3 months|14 out of the 23 in control group completed 3 month survey and 19 out of 24 in patient navigation group completed the 3 month survey.|||participant|||Number
2679162|NCT01414036|Primary|Engagement in Smoking Cessation Treatment|This is a dichotomous variable, Y/N, based on a) completion of > 1 quit line counseling session (based on self-report) OR b) > 1 PCP visit in which smoking cessation treatment is discussed (patient self-report and medical record review of progress notes) OR c) Completion of > 1 session of a BMC smoking cessation group (medical record review).|3 months|14 out of the 23 in control group completed 3 month survey and 19 out of 24 in patient navigation group completed the 3 month survey.|||participant|||Number
2679163|NCT01414010|Primary|Bacteria Prevalence in Stool|"The most prevalent bacterial genera within the study population~Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Days 10 and 14 After Treatment: Average of Days 21, 28, and 56"|Day 0 to 56|The investigators expanded their studies on the probiotic (Saccharomyces boulardii) to constitute a full, separate study. Reference: NCT01473368.|||percentage of bacterial genera in stool||Standard Deviation|Mean
2679164|NCT01413958|Secondary|Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities (RQLQ)|"The RQLQ is a disease-specific quality of life questionnaire developed to measure the physical, emotional, and social problems in adults with rhinoconjunctivitis. Questions were divided into 7 domains: sleep (3 questions), non-hay fever symptoms (7 questions), practical problems (3~questions), nasal symptoms (4 questions), eye symptoms (4 questions), and activities (3 questions), and emotions (4 questions). Individual items within the RQLQ are equally weighted. The questionnaire is analyzed directly from the scores recorded and the results are expressed as the mean score for each of the domains (i.e., domain scores range from 0 to 6). Six represents the greatest impairment and 0 represents the least impairment. Overall quality of life score is the mean score for all domains."|Up to Day 8|The Intent-To-Treat Population was used in this analysis. There were 285 evaluable participants for the Placebo Group at Day 8.|||Scores on a scale||Standard Deviation|Mean
2679165|NCT01413958|Secondary|Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period.|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.|Baseline and Day 1, 2, 3, 4, 5, 6, and 7|Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Days 5 and 7, 287 on Days 1, 3, 4 and 286 on Days 2 and 6. For the Placebo Group, there were 286 evaluable participants on Days 1, 2, 3, 5, 6 and 285 on Day 7 and 284 on Day 4.|||Scores on a scale||Standard Deviation|Mean
2679166|NCT01413958|Secondary|Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.|Baseline and Day 2, 3, 4, 5, 6, and 7|The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Days 1, 2, 3, 4, 5, 7 and 286 evaluable participants at Day 6. For the Placebo Group, there were 287 evaluable participants on Day 1, 286 on Days 3, 5, 6 and 285 on Days 2, 4, 7.|||Scores on a scale||Standard Deviation|Mean
2679167|NCT01413958|Secondary|Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period.|Baseline and Day 1, 2, 3, 4, 5, 6, and 7|The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Day 5, 287 on Days 1, 3, 4, 6 and 286 on Day 2. For the Placebo Group, there were 287 evaluable participants on Day 1, 286 on Days 2, 5, 6, 285 on Days 3 and 7 and 284 on Day 4.|||Scores on a scale||Standard Deviation|Mean
2679168|NCT01413958|Secondary|Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period.|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period.|Baseline and Day 2, 3, 4, 5, 6, and 7|The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Days 2 - 5 and 287 on Day 6. For the Placebo Group, there were 287 evaluable participants on Day 1, 286 on Days 2, 5, and 6 and 285 on Days 3, 4, and 7.|||Scores on a scale||Standard Deviation|Mean
2679208|NCT01413087|Secondary|Extent of Exposure - BC-819 Total Number of Treatments|Measured by the average and median number of treatments of the patients to BC-819 and gemcitabine.|24 months|ITT population comprised all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population|||number of treatments||Standard Deviation|Mean
2679209|NCT01413087|Secondary|Extent of Exposure - BC-819 Total Exposure (mg)|Measured by the average and median exposure of the patients to BC-819 and gemcitabine.|24 months|ITT population comprised all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population|||mg||Standard Deviation|Mean
2679169|NCT01413958|Secondary|Mean Change From Baseline in Morning Predose Instantaneous Nasal Congestion Symptom Score|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual morning instantaneous nasal scores was reported as the daily morning instantaneous nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.|||Scores on a scale||Standard Deviation|Mean
2679170|NCT01413958|Secondary|Day 7 Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms). The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score over the entire treatment period.|Baseline and Day 7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and at Day 7 was 285.|||Scores on a scale||Standard Deviation|Mean
2679171|NCT01413958|Secondary|Time to Maximal Phenylephrine Effect|The time to maximal phenylephrine effect was defined as the earliest time that the nasal congestion symptom score in the Phenylephrine treatment group demonstrated the greatest numerical difference from the Placebo treatment group in change from baseline. The mean change from baseline scores for a Phenylephrine treatment arm and for the Placebo treatment arm at each timepoint of the treatment period (Day 1 morning, Day 1 evening, etc) was calculated. The difference between the Phenylephrine treatment arm and Placebo treatment arm mean at each timepoint of the treatment period was calculated. The time to maximal phenylephrine effect was the first timepoint at which the difference between the Phenylephrine treatment arm and the Placebo treatment arm was greatest. The results for the Placebo treatment arm are not presented as the result of this outcome measure is only relevant for the Phenylephrine treatment group.|Baseline up to Day 7|All participants in the intent-to-treat population (all randomized participants who received at least 1 tablet of study medication).|||Days|||Number
2679172|NCT01413958|Secondary|Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.|Baseline and Day 1, 2, 3, 4, 5, 6, 7|The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 287 evaluable participants on Day 1 and 288 on Day 2 - 7. For the Placebo Group, there were 286 evaluable participants on Days 1, 2, 3, 4, 5, 6 and 285 on Day 7.|||Scores on a scale||Standard Deviation|Mean
2679173|NCT01413958|Secondary|Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period.|Baseline and Day 1, 2, 3, 4, 5, 6, and 7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). For the Phenylephrine Group, there were 287 evaluable participants on Day 1 and 288 on Days 2 - 7. For Placebo Group, there were 286 evaluable participants on Days 1, 2, 3, 4, 5, 6, and 285 on Day 7.|||Scores on a scale||Standard Deviation|Mean
2679174|NCT01413958|Secondary|Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score|The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.|||Scores on a scale||Standard Deviation|Mean
2679210|NCT01413087|Secondary|Extent of Exposure - Gemcitabine Total Number of Treatments|Measured by the average and median number of treatments of the patients to BC-819 and gemcitabine.|24 months|ITT population comprised all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population|||number of treatments||Standard Deviation|Mean
2679211|NCT01413087|Secondary|Extent of Exposure - Gemcitabine Total Exposure (g)|Measured by the average and median number of exposure of the patients to BC-819 and gemcitabine.|24 months|ITT population comprised all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population|||g||Standard Deviation|Mean
2679175|NCT01413958|Secondary|Mean Change From Baseline in the Evening Reflective Symptom Assessment Score|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily evening nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.|||Scores on a scale||Standard Deviation|Mean
2679176|NCT01413958|Secondary|Mean Change From Baseline in the Morning Reflective Symptom Assessment Score|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily morning nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.|||Scores on a scale||Standard Deviation|Mean
2679177|NCT01413958|Primary|Mean Change From Baseline in Daily Reflective Nasal Congestion Score|The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), and 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.|Baseline and Days 1-7|Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286.|||Scores on a scale||Standard Deviation|Mean
2679178|NCT01413750|Secondary|Maximum Tolerated Dose (MTD) (Phase I)|The highest dose tested in which fewer than 33% of patients experience an attributable DLT to the study drug, when at least 6 patients are treated at that dose and are evaluable for toxicity. The MTD is one dose level below the lowest dose in which 33% or more of the patients experience a DLT. The MTD is based on the first cycle of therapy. The recommended Phase II dose is generally the MTD, although secondary considerations of toxicity and dose reductions on subsequent cycles and other secondary considerations may result in the recommended Phase II dose being below the MTD.|4 weeks from start of treatment, up to 1 year||||mg|||Number
2679179|NCT01413750|Secondary|Dose Limiting Toxicity (DLT) (Phase I)|DLT is defined as any grade III or higher non-hematological toxicity except nausea, vomiting or alopecia. Nausea or vomiting (> grade 2) that last longer than 48 hours despite maximal medical therapy. Absolute neutrophil count < 1000/uL lasting longer than 7 days. Grade 4 thrombocytopenia (platelet < 25,000/uL). Grade 3 or 4 neutropenia associated with sepsis or fever > 38 C. Delay in starting cycle 2 by more than 2 weeks due to toxicity.Abnormal non-hematological laboratory criteria (Grade 3 or higher) will be considered a DLT, if clinically significant and drug-related. If baseline value is elevated prior to drug therapy, an increase will not be considered a DLT unless there is an elevation by more than 2 grades, and it is of clinical significance. Dose escalation schedule for vorinostat: 600 mg QD; 800 mg QD.|4 weeks from start of treatment, up to 1 year||||participants with DLTs|||Number
2679180|NCT01413750|Primary|Progression-free Survival (PFS)|"Estimated using the product-limit method of Kaplan and Meier.~PFS defined as time from randomization to progression or death due to any cause.~Progression defined as Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 1 year|Due to early termination phase II portion of the study did not reach planned accrual.|||months||95% Confidence Interval|Median
2679181|NCT01413542|Secondary|Effect of Treatment (DPP4 Inhibition vs. Placebo) on Venous GLP-1 Levels in Response to Arterial GLP-1 Infusion||Blood for analysis of GLP-1 levels was obtained one hour after sitagliptin (DPP4 inhibition) vs. placebo administration and after each dose of GLP-1||||pmol/L||Standard Error|Mean
2679182|NCT01413542|Secondary|Effect of Treatment (ACE or DPP4 Inhibition, or Combined) on Norepinephrine (NE) Release (Arterial Venous Gradient) in Response to Substance P (SP)||Blood for analysis of norepinephrine (NE) release was obtained 60 minutes after sitagliptin (DPP4 inhibition) vs. placebo and after each assessment of FBF (see primary outcome measure)||||pg/mL||Standard Error|Mean
2679183|NCT01413542|Secondary|Assess Effect of ACE and/or DPP4 Inhibition on Heart Rate Response to Substance P (SP)||Heart rate was measured every 5 minutes throughout the study day (and thus during each dose of peptide infusion)||||beats per minute||Standard Error|Mean
2679184|NCT01413542|Secondary|Assess Tissue Type Plasminogen Activator (tPA) Release|Following measurement of FBF, samples will be obtained to determine the effect of ACE inhibition and/or DPP4 inhibition on tPA release in response to bradykinin and substance P (SP) (group 1)|Blood for analysis of tPA release was obtained 60 minutes after sitagliptin (DPP4 inhibition) vs. placebo and after each assessment of FBF (see primary outcome measure)||||estimate of difference (ng/min/100mL)||95% Confidence Interval|Number
2679246|NCT01412866|Primary|Initiation of Smoking Cessation Treatment|Started smoking cessation treatment|2 months||||participants|||Number
2679185|NCT01413542|Primary|The Effect of Enalaprilat (ACE Inhibition), Sitagliptin (DPP4 Inhibition), or the Combination on the Vasodilator Response (Forearm Blood Flow) to Substance P (SP) and Bradykinin (Group 1) or Glucagon Like Peptide-1 and Brain Naturetic Peptide (Group 2).|Forearm blood flow (FBF) was measured by strain gauge plethysmography at the completion of each dose of intra-arterial peptide. A dose response curve was therefore constructed for each vasoactive peptide substrate. The effect of sitagliptin (DPP4 inhibition) vs. placebo and enalaprilat (ACE inhibition) vs. vehicle on the forearm blood flow response to each peptide could then be determined.|60 minutes post-placebo or sitagliptin (DPP4 inhibition) and over last 2 minutes of each 5 min infusion per peptide dose (30 min washout between peptides); sequence repeated with enalaprilat (ACE inhibition) or vehicle|In Group 1: Peptide 1=Max dose Bradykinin; Peptide 2=Substance P (SP) In Group 2: Peptide 1=GLP-1; Peptide 2=BNP (FBF expressed as percent change for both peptides) ACE inhibition=enalaprilat DPP4 inhibition=sitagliptin|||estimate of difference(ml/min/100ml FBF)||95% Confidence Interval|Mean
2679186|NCT01413516|Primary|7 Day Point Prevalence Abstinence From All Forms of Tobacco|Self report of being quit for 7 continuous days at the time of the 4-week follow-up survey confirmed by saliva cotinine or urine anabasine verification.|4 weeks after beginning study||||participants|||Number
2679187|NCT01413503|Primary|Number of Patients With Complete (CR), Partial (PR), or Minor (MR) Response and Without Progressive Disease|Patients with complete (CR), partial (PR), or minor (MR) response and without progressive disease 1 year from initial treatment, using RECIST RESPONSE CRITERIA for measurable soft tissue tumor: CR=No Tumor (Primary or metastatic); catacholamines, metanephrines and chromogranin A all normal. PR=Primary and all measurable sites decreased >50%; number of positive bone sites decreased by >50%; bone marrow tumor decreased by 50%. MR=No new lesions; >50% reduction of any measurable lesion (primary or metastases); <25% increase in any existing lesion.|After 1 year from initial treatment||||Participants|||Count of Participants
2679188|NCT01413360|Secondary|The Change in Serum Interleukin 22 Level From Baseline to 12 Weeks|Serum interleukin 22(IL-22)level after 12 weeks of high vitamin C administration and Baseline IL-22 level|Baseline and 12 weeks||||pg/mL||Full Range|Median
2679189|NCT01413360|Primary|The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks|Serum alanine aminotransferase (ALT) level after 12 weeks of high dose vitamin C administration and Baseline serum ALT level|Baseline and 12 weeks||||IU/L||Full Range|Median
2679190|NCT01413204|Secondary|Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs||Week 24|||||||
2679191|NCT01413204|Secondary|Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test||Week 24|||||||
2679192|NCT01413204|Secondary|Change in Blood Pressure||Week 24|||||||
2679193|NCT01413204|Secondary|Change in Body Weight||Week 24|||||||
2679194|NCT01413204|Secondary|Change in Fasting Plasma Glucose||Week 24|||||||
2679195|NCT01413204|Primary|Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)||baseline and 24 weeks|Full analysis set, last observation carried forward|||percent HbA1C||Standard Error|Least Squares Mean
2679196|NCT01413191|Other Pre-specified|Tumor Shrinkage for All Efficacy-evaluable Patients||Up to 2 years|No participants was evaluable due to progression.||||||
2679197|NCT01413191|Secondary|Durable Response Rate|Durable Response Rate is the proportion of subjects with a confirmed complete or partial response ≥ 6 months in duration.|Up to 2 years||||Participants|||Count of Participants
2679198|NCT01413191|Secondary|Overall Survival (OS)||Up to 2 years||||WEEKS||95% Confidence Interval|Median
2679199|NCT01413191|Secondary|Progression-free Survival (PFS)||Up to 2 years||||WEEKS||95% Confidence Interval|Median
2679200|NCT01413191|Secondary|Duration of Response|Duration of response will be summarized by using descriptive statistics. Median duration of response will be estimated by using the Kaplan-Meier method.|From the date criteria are first met for complete or partial response until the first date of documented progression, assessed up to 2 years|Duration of response could not be calculated, as there were no responders.||||||
2679201|NCT01413191|Secondary|Disease Control Rate|Disease Control Rate is the proportion of subjects with a confirmed complete or partial response of any duration or stable disease ≥3 months in duration.|Up to 2 years||||Participants|||Count of Participants
2679202|NCT01413191|Primary|Number of Participants With Response|Response rate is the percentage of subjects with a confirmed complete or partial response using revised Response Evaluation Criteria in Solid Tumors (RECIST) where changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria: Complete Response (CR): Disappearance all target lesions; pathological lymph nodes reduction in short axis to <10 mm. Partial Response (PR): 30% or > decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): 20% or > increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if smallest on study); and sum must demonstrate absolute increase of 5+ mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study.|Baseline to 2 years|One participant was not evaluable for response assessment.|||participants|||Number
2679203|NCT01413178|Secondary|Overall Survival (OS)||From time of ASCT to 3 years||||Participants|||Count of Participants
2679204|NCT01413178|Secondary|Number of Participants That Had Grade 3-4 Toxicities.||At day 90 post SCT (Stem Cell Transplantation)||||participants|||Number
2679205|NCT01413178|Secondary|Treatment-Related Mortality (TRM) Between 2 Arms.||100 days post treatment||||Participants|||Count of Participants
2679206|NCT01413178|Secondary|Number of Participants With Complete Response (CR)|Complete response (CR), evaluated 90 days from transplant, defined as (i) negative immunofixation of the multiple myeloma (MM) protein in urine and serum, (ii) disappearance of any soft tissue plasmacytomas, and (iii) less than 5% plasma MM cells in the bone marrow. International Myeloma Working Group uniform response criteria.|Evaluated 90 days from transplant.||||Participants|||Count of Participants
2679207|NCT01413178|Primary|Progression-Free Survival (PFS)|Participants that are still alive and without Multiple Myeloma 3 years after Stem cell Transplantation.|3 years after transplant||||Participants|||Count of Participants
2680315|NCT01402128|Secondary|Changes in HDL-C(High Density Lipoprotein-cholesterol)|HDL-C(High Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||mg/dl||Standard Deviation|Mean
2679212|NCT01413087|Secondary|Serological Tumor Marker: CA 19-9|Serum was collected for quantitative measurement of CA 19-9.|24 months|ITT population comprised of all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population|||U/mL||Standard Deviation|Mean
2679213|NCT01413087|Secondary|Quality of Life Using the Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire|The FACT-G is a 27-item compilation of general questions divided into 4 primary QoL domains: physical well-being, social/family well-being, emotional well-being and functional well-being. The total FACT-G scores will be summarized by descriptive statistics (e.g., n, mean, median, standard deviation and range). The individual FACT-G score will be presented by frequency and percentage. Scores range from 0-108. High total scores represent better general QoL.|Screening, Visit 4 (post gemcitabine induction), Visit 9 (5 weeks), Visit 13 (9 weeks), every 6 months after Visit 13|ITT population comprised all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population|||units on a scale||Standard Deviation|Mean
2679214|NCT01413087|Secondary|Quality of Life (QoL) Assessed by Karnofsky Performance Status (KPS)|"Quality of life will be assessed by the The Karnofsky Performance Status (KPS) Index. KPS scores over time will be compared to those at baseline and changes from baseline will be presented.~KPS scores are on a scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100) of 0 (dead) to 100 (Normal no complaints; no evidence of disease)."|Screening, Visit 4 (post gemcitabine induction), Visit 9 (5 weeks), Visit 13 (9 weeks)|ITT population comprised of all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population|||score on a scale||Full Range|Median
2679215|NCT01413087|Secondary|Resectability of the Target Tumor Lesion|Resectability of the target tumor lesion was determined by CT/MRI as defined in the National Comprehensive Cancer network (NCCN) guidelines. Resectable tumors have no arterial tumor contact (celiac axis [CA], superior mesenteric artery [SMA], or common hepatic artery [CHA]) and no tumor contact with the superior mesenteric vein (SMV) or portal vein (PV) or ≤180° contact without vein contour irregularity. *Not Applicable refers to another clinically significant abnormality that interfered with resectability determination of the target tumor lesion.|an average of 16 weeks|ITT population comprised all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population.|||Participants|||Count of Participants
2679216|NCT01413087|Secondary|Response Rate of Target Lesion|"Response rate will be assessed both for the primary target tumor lesion alone and overall, including development of metastases. Target tumor lesions are identified and the longest diameter of the target lesion is measured by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines.~Complete response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.~Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~Progressive Disease: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also show an increase of at least 5 mm.~Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|8 weeks|ITT population comprised of all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population|||Participants|||Count of Participants
2679217|NCT01413087|Secondary|Overall Survival (OS)|OS was calculated from the date of consent until death due to any cause.|24 months|ITT population comprised all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population|||years||95% Confidence Interval|Median
2679218|NCT01413087|Primary|Progression-free Survival (PFS)|To compare the effect of intratumoral endoscopic ultrasound injection of BC-819 administered with intravenous gemcitabine on progression-free survival. PFS was defined as the time from the date of consent until objective tumor progression or death. Median PFS by Kaplan-Meier analysis was used for evaluation. The target tumor lesion was identified and the longest diameter of the target lesion was measured according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. For disease evaluations after treatment, scans conducted at baseline that were used for tumor measurements were repeated.|24 months|ITT comprised of all subjects who received any treatment with either gemcitabine or BC-819 and whose tumors were positive for H19. All 12 patients were included in the ITT population.|||months||95% Confidence Interval|Median
2679219|NCT01412983|Secondary|Overall Comfort|The mean difference in comfort-related symptoms/complaints scores between lens groups. Rated on a scale of 0-100 with 100 being the most favorable score.|One week|All eligible dispensed eyes|||units on a scale|Participants|Standard Deviation|Least Squares Mean
2679220|NCT01412983|Primary|Visual Acuity|The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups.|One week|All eligible dispensed eyes|||LogMAR|Participants|Standard Deviation|Least Squares Mean
2679221|NCT01412957|Secondary|Maximum Post-baseline Change From Baseline in Corrected QT (QTc) Interval|QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle as measured by electrocardiogram (ECG). QTc is the QT interval corrected for heart rate. To evaluate the effect of panitumumab treatment on the QTc interval length among participants treated with panitumumab, ECGs were collected at the following time points from participants randomized to panitumumab arm at a limited number of sites: Week 1 prior to the first panitumumab infusion (Baseline) and within 30 minutes following the end of the first infusion of panitumumab (Cmax), Week 7 after 3 doses of panitumumab (steady state), and at the safety follow-up visit. The ECGs were submitted for independent central review to calculate the reported QTc interval. QTc was calculated using both the Bazett correction (QTcB) and the Fridericia correction (QTcF).|Baseline (pre-dose), Week 1 and Week 7 (post-dose) and 4 weeks after the last dose (Safety Follow-up visit)|QTc Analysis Set is defined as the subset of participants in the Safety Analysis Set who received at least one panitumumab dose and were enrolled at the limited number of sites participating in QTc evaluation and had baseline and at least 1 post-baseline QTc assessment.|||msec||Standard Deviation|Mean
2680316|NCT01402128|Secondary|Changes in LDL-C (LDL Low Density Lipoprotein-cholesterol)|LDL-C (LDL Low Density Lipoprotein-cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||mg/dl||Standard Deviation|Mean
2679222|NCT01412957|Secondary|Number of Participants With Adverse Events (AEs)|The severity of each AE was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Grade 1 = Mild; 2 = Moderate (discomfort enough to cause interference with usual activity); 3 = Severe (incapacitating with inability to work or do usual activity); 4 = Life-threatening and 5 = Fatal), with the exception of the skin-or nail-related AEs which were graded using a CTCAE version 3.0 with modifications. A serious AE was defined as an AE that met at least 1 of the following criteria: • fatal, • life-threatening, • required in-patient hospitalization or prolongation of existing hospitalization, • resulted in persistent or significant disability/incapacity, • congenital anomaly/birth defect, and/or • other medically important serious event. Treatment-related AEs (TRAEs) are those the investigator considered there was reasonable possibility that the event might have been caused by study drug.|From first dose until 30 days after last dose; median safety reporting periods were 4.2 months and 2.2 months for panitumumab plus BSC arm and BSC alone arm, respectively.|Safety Analysis Set (all randomized participants)|||participants|||Number
2679223|NCT01412957|Secondary|Objective Response Rate in Participants With Wild-type RAS|Objective response rate is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator's assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesions not qualifying for either CR or PD and no new lesions.|Response was assessed at Week 4, Week 8, and then every 8 weeks until the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).|Wild-type RAS Efficacy Analysis Set|||percentage of participants||95% Confidence Interval|Number
2679224|NCT01412957|Secondary|Objective Response Rate|Objective response rate (ORR) is defined as the percentage of participants with either a complete response (CR) or partial response (PR) per RECIST version 1.1. Radiographic tumor assessments and investigator's assessment of response were performed at Week 4, Week 8, and then every 8 weeks until disease progression (radiographic or clinical progression). CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR: At least a 30% decrease in the size of target lesions with no progression of non-target lesions and no new lesions, or, the disappearance of all target lesions with persistence of one or more non-target lesions not qualifying for either CR or PD and no new lesions.|Response was assessed at Week 4, Week 8, and then every 8 weeks until the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).|ITT analysis set|||percentage of participants||95% Confidence Interval|Number
2679225|NCT01412957|Secondary|Progression Free Survival (PFS) in Participants With Wild-type RAS|"PFS was defined as the time from the randomization date to the date of disease progression per RECIST version 1.1 or death.~Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions, or an increase in size of non-target lesions thought be ≥ 20% with an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date."|From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).|Wild-type RAS Efficacy Analysis Set|||months||95% Confidence Interval|Median
2679226|NCT01412957|Secondary|Overall Survival in Participants With Wild-type RAS|A secondary efficacy endpoint was overall survival in participants with wild-type rat sarcoma viral oncogene homolog (RAS) (without mutation in exons 2 [codons 12 and 13], 3 [codons 59 and 61], and 4 [codons 117 and 146] of KRAS and neuroblastoma RAS viral oncogene (NRAS)). In participants with wild-type RAS, RAS mutation status was defined by KRAS exon 2 mutation status per clinical trial assay testing and mutation status of KRAS exon 3 and 4 and NRAS exons 2, 3 and 4 per Sanger bi-directional sequencing. Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date.|From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 36.1 weeks (panitumumab plus BSC: 43.7 weeks; BSC alone: 23.6 weeks).|Wild-type RAS Efficacy Analysis Set (subset of participants in the ITT Analysis Set without mutation in exon 2, 3, and 4 of KRAS or NRAS)|||months||95% Confidence Interval|Median
2679227|NCT01412957|Secondary|Progression-free Survival|Progression-free survival (PFS) was defined as the time from the randomization date to the date of disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Progressive disease (PD): At least a 20% increase in the size of target lesions compared with the smallest size since treatment started and an absolute increase of at least 5 mm, any new lesions or an increase in size of non-target lesions thought be ≥ 20% and an absolute increase of at least 5 mm, or significant increase in pleural effusions, ascites or other fluid collections with cytologic proof of malignancy. Participants who were alive and did not meet the criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date.|From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).|ITT Analysis Set|||months||95% Confidence Interval|Median
2679248|NCT01412801|Secondary|Percentages of Infants Who Experienced Unsolicited Adverse Events|Safety in Infants was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events since birth to study termination|Birth to Study Termination, for up to 24 weeks|Safety Set (Unsolicited AEs, Infants)|||percentages of Infant subjects|||Number
2680317|NCT01402128|Secondary|Changes in Visceral Adipose Tissue|Visceral adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||cm^3||Standard Deviation|Mean
2679228|NCT01412957|Primary|Overall Survival|Overall survival was defined as the time from the randomization date to the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date and participants with survival data obtained after the planned analysis data cut-off date had survival censored at the cut-off date.|From randomization to the last on-study or long-term follow-up visit, as of the data cut-off date of 10 June 2014. The median follow-up time was 34.9 weeks (panitumumab plus BSC: 41.0 weeks; BSC alone: 25.5 weeks).|Intent to Treat (ITT) Analysis Set (all randomized participants); participants in the ITT Analysis Set were required to have wild-type KRAS exon 2 (codons 12 and 13, alleles G12A, G12D, G12R, G12C, G12S, G12V, or G13D) per protocol.|||months||95% Confidence Interval|Median
2679229|NCT01412944|Secondary|Relationship Between Response to AIN457 and Failed Response to Previous Biologic Psoriasis Therapy|This outcome measure was not analyzed due to the small sample size of the study (43 participants).|End of study|||||||
2679230|NCT01412944|Secondary|Number of Participants Who Developed Anti-secukinumab Antibodies|The development of anti-secunimubab anti-bodies would decrease a participant's ability to respond to secukinumab treatment.|Baseline, weeks 12, 24 and 40|Participants from full analysis set (FAS), who had values at baseline and post-baseline, were included in the analysis. The FAS included all participants to whom treatment was assigned.|||Number of participants|||Number
2679231|NCT01412944|Secondary|Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100)|The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.|Baseline, weeks 8, 16, 24, 32 and 40|The FAS population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.|||Percent change||Standard Deviation|Mean
2679232|NCT01412944|Secondary|Mean Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Scores|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Baseline, weeks 8, 16, 24, 32 and 40|The FAS population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.|||Percent change||Standard Deviation|Mean
2679233|NCT01412944|Secondary|Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral warts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A DLQI of 0 or 1 indicates no impairment or little impairment, respectively. A negative mean percentage change from baseline indicates improvement."|Baseline, Week 8, Week 16, Week 24, Week 32,up to Week 40|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.|||Percentage of participants|||Number
2679234|NCT01412944|Secondary|Percentage of Participants in Each IGA Mod 2011 Score Category|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.|||Percentage of participants|||Number
2679235|NCT01412944|Secondary|Mean Percent Change From Baseline in PASI Scores|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.|Baseline, weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had post-baseline values at the given weeks, were included in the analysis for that week.|||Percent change||Standard Deviation|Mean
2679247|NCT01412801|Primary|Geometric Mean Antibody Transfer Ratio Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL), for GBS Serotypes Ia, Ib and III at Delivery/Birth.|The Geometric mean transfer ratio of GBS-specific Ab against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.|Day of delivery/birth|Full Analysis Set (FAS)-Maternal and Infant Subjects: Maternal subjects provided at least one evaluable serum sample result at delivery; infant subjects provided at least one evaluable sample result at birth (from cord blood, or peripheral blood within 72 hours when cord blood was unavailable).|||Ratios||95% Confidence Interval|Geometric Mean
2679236|NCT01412944|Secondary|Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 40|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had values at a given week, were included in the analysis for that week.|||Percentage of participants|||Number
2679237|NCT01412944|Primary|Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in PASI After 12 Weeks of Treatment in Study AIN457A2304) With Investigator's Global Assessment Model 2011 (IGA Mod 2011) 0 or 1 Response|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.|Week 8|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had week 8 values, were included in the analysis.|||Percentage of participants|||Number
2679238|NCT01412944|Primary|Percentage of Participants (Who Achieved a Partial Response Defined as ≥ 50% But < 75% Improvement in Psoriasis Area and Severity Index (PASI) After 12 Weeks of Treatment in Study AIN457A2304) With 75% Improvement From Baseline in PASI|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|Week 8|The full analysis set (FAS) population was used for this analysis. The FAS included all participants to whom treatment was assigned. Only participants from the FAS, who had week 8 values, were included in the analysis.|||Percentage of participants|||Number
2679239|NCT01412918|Secondary|Percentage of Participants Which Showed Presence of SCN9 Gene Expression.|Percentage of participants with and without tinnitus provided a genetic sample via saliva to determine presence of SCN9 gene expression.|Single visit (day 1), evaluated at the time of the genetic collection.||||% of participants with gene expression|||Number
2679240|NCT01412918|Primary|Determine the Percentage of Participants for Which the Inhibitor™ Tinnitus Masking Device Effected Tinnitus Perception|Determine percentage of particpants with a change in tinnitus perception to evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device.|Single visit (day 1), assessed the day of visit||||percentage of participants|||Number
2679241|NCT01412879|Secondary|5-year Overall Survival (OS)|Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.|Up to 5 years|All eligible patients who started treatment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2679242|NCT01412879|Secondary|Response Rate (Complete and Partial Response)|Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.|Up to 9 months|All eligible patients who started treatment were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2679243|NCT01412879|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Up to 8 months (Assessed at the beginning of each cycle of treatment, at restaging, and at post transplant.)|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.|||Participants|||Number
2679244|NCT01412879|Primary|Progression-Free Survival (PFS) at 2 Years|Disease progression is defined using the 2007 revised Cheson et al. criteria that is at least 50% increase in sum of the product of the diameters (SPD) of target measurable nodal lesions over the smallest sum observed, or >= 50% increase in greatest transverse diameter (GTD) of any nodal > 1 cm in shortest axis, or >= 50% increase in the SPD of other target measurable lesions over the smallest sum observed, any new bone marrow involvement, any new lesion, lymph node with long axis is > 1.5 cm or if both long and short axes are > 1 cm, PET positive if patients with no pretreatment PET scan or when PET scan was positive before therapy. Progression-free survival is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|Up to 2 years|All eligible patients who started treatment were included in the analysis|||percentage of participants||95% Confidence Interval|Number
2679245|NCT01412866|Secondary|Days of Nicotine Abstinence||6 months|||||||
2679249|NCT01412801|Secondary|Percentages of Subjects Who Experienced Unsolicited Adverse Events|Safety was assessed in terms of the number of subjects who experienced Unsolicited Adverse Events after receiving one dose of the GBS Trivalent Vaccine|Day 1 to Study Termination, for up to 24 weeks|Safety Set (Unsolicited AEs, Maternal Subjects)|||percentages of subjects|||Number
2679250|NCT01412801|Secondary|Percentages of Subjects With Solicited Systemic AEs|Safety was assessed in terms of the number of subjects with solicited systemic AEs after receiving one dose of the GBS Trivalent Vaccine|From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks|Safety Set (Solicited AEs, Maternal Subjects)|||percentages of Subjects|||Number
2679251|NCT01412801|Secondary|Percentages of Subjects With Solicited Local Adverse Events (AEs)|Safety was assessed in terms of the number of subjects with solicited local AEs after receiving one dose of the GBS Trivalent Vaccine|From 6 Hours to Day 7 After Each Vaccination, for up to 24 weeks|Safety Set (Solicited AEs, Maternal Subjects)|||percentage of Subjects|||Number
2679252|NCT01412801|Secondary|Percentages of Maternal Subjects With The Enzyme-linked Immunosorbent Assay (ELISA) Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold at Delivery|Immunogenicity was measured in terms of the percentages of maternal subjects with ELISA Antibody Levels for GBS Serotypes Ia, Ib and III Above a Specific Threshold after receiving one dose of GBS Trivalent Vaccine.Threshold values of 0.1, 0.2, 0.5, 1, 2, 3, 5, and 8 μg/mL were used for serum concentrations for maternal subjects.|Day of Delivery|FAS (Maternal Subjects)|||Percentage of maternal subjects|||Number
2679253|NCT01412801|Secondary|Vaccine Induced Maternal Serotype Specific GBS Antibody Levels for GBS Serotypes Ia, Ib and III at Day 1, 15, 31 and at Delivery|Immunogenicity was measured as Geometric Mean Concentration of Antibody levels for GBS Serotypes Ia, Ib and III after receiving one dose of GBS Trivalent Vaccine.|Day 1, 15, 31 and at Delivery|FAS (Maternal Subjects in the Exposed Population) who -Secondary objective serum GMC: provided at least one evaluable sample result at day 1 (prior to vaccination), day 15, day 31, or at delivery;- Secondary objective kinetics: provided at least one evaluable serum sample at day 1 (prior to vaccination), day 15, day 31, and at delivery.|||µg/mL||95% Confidence Interval|Geometric Mean
2679254|NCT01412801|Primary|Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth|GMCs of Group B Streptococcus (GBS)-specific Abs against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.|Day of delivery/birth|Full Analysis Set (FAS)-Maternal and Infant Subjects: Maternal subjects provided at least one evaluable serum sample result at delivery; infant subjects provided at least one evaluable sample result at birth (from cord blood, or peripheral blood within 72 hours when cord blood was unavailable).|||μg/mL||95% Confidence Interval|Geometric Mean
2679255|NCT01412710|Secondary|Glycemic Control|hemoglobin A1C blood test|Baseline|A1C baseline.|||Percentage of Hemoglobin||Standard Deviation|Mean
2679256|NCT01412710|Primary|Blood Lipid|Total cholesterol will be used as surrogate measures for cardiovascular disease risk.|Baseline|Total cholesterol baseline.|||mg/dl||Standard Deviation|Mean
2679257|NCT01412554|Secondary|Ultrasound Abdomen|Ultrasound quantification of abdominal adipose tissue|One-day visit. Final analyses of the whole cohort during 2012-2013|||||||
2679258|NCT01412554|Secondary|Echocardiography|Transthoracic echocardiography will be performed using a VIVID E9 (or VIVID 7) echocardiographic scanner (GE Vingmed, Horten) with 1,7-MHz probe in second harmonic mode and optimal gain and contrast.Left ventricular (LV) internal dimension, intraventricular septal thickness and LV posterior wall thickness will be measured as well as epicardial adipose tissue. We will also evaluate biplane Simpson ejection fraction and valvular incompetence|One-day visit, final analyses 2012-2013|||||||
2679259|NCT01412554|Secondary|Sympathoadrenal Activity During Rest and Stress Tests|A mental arithmetic stress test will be announced and performed immediately after the glucose clamp, to assess the effects of increased adrenaline and noradrenaline when hepatic glucose production is suppressed by hyperinsulinaemia. Blood pressure, heart rate and catecholamine blood-levels are measured at pre-defined intervals.|One-day visit and analyses will be done during 2012-2013|||||||
2679260|NCT01412554|Primary|Exploring Insulin Sensitivity After 10-20 Years of Follow-up|The primary outcome is insulin sensitivity measured as the glucose disposal rate (GDR) (mg/kg/min), calculated from the average glucose infusion rate during the last 20 minutes of a 120 minutes hyperinsulinaemic isoglycaemic glucose clamp.|20 years|||||||
2679261|NCT01412554|Primary|Exploring Insulin Sensitivity After 10-20 Years of Follow-up|The primary outcome is insulin sensitivity measured as the glucose disposal rate (GDR) (mg/kg/min), calculated from the average glucose infusion rate during the last 20 minutes of a 120 minutes hyperinsulinaemic isoglycaemic glucose clamp.|One-day visit and the analyses will be done when all patients are examined in the period 2012-2013||||mg/kg/min||Standard Deviation|Mean
2679262|NCT01412541|Secondary|Secondary Safety #8 - Percentage of Subjects With Readmission for Cardiovascular Events at 12 Months.|Percentage of subjects with Readmission for cardiovascular events at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679263|NCT01412541|Secondary|Secondary Safety #8 - Percentage of Subjects With Readmission for Cardiovascular Events at 6 Months.|Percentage of subjects with Readmission for cardiovascular events at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679264|NCT01412541|Secondary|Secondary Safety #8 - Percentage of Subjects With Readmission for Cardiovascular Events at 1 Month.|Percentage of subjects with Readmission for cardiovascular events at 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679265|NCT01412541|Secondary|Secondary Safety #7 - Percentage of Subjects With Major Vascular Complications at 12 Months.|Percentage of subjects with Major vascular complications at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679266|NCT01412541|Secondary|Secondary Safety #7 - Percentage of Subjects With Major Vascular Complications at 6 Months.|Percentage of subjects with Major vascular complications at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2680318|NCT01402128|Primary|Changes in Body Fat Mass(kg)|Body fat mass(kg) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||kg||Standard Deviation|Mean
2679267|NCT01412541|Secondary|Secondary Safety #7 - Percentage of Subjects With Major Vascular Complications at 1 Month.|Percentage of subjects with Major vascular complications at 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679268|NCT01412541|Secondary|Secondary Safety #6 - Percentage of Subjects With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 12 Months.|Percentage of subjects with Reintervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679269|NCT01412541|Secondary|Secondary Safety #6 - Percentage of Subjects With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 6 Months.|Percentage of subjects with Reintervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679270|NCT01412541|Secondary|Secondary Safety #6 - Percentage of Subjects With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 1 Month.|Percentage of subjects with Reintervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature at 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679271|NCT01412541|Secondary|Secondary Safety #5 - Percentage of Subjects With Target Vessel Revascularization (TVR) at 12 Months.|Percentage of subjects with Target Vessel Revascularization (TVR) at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679272|NCT01412541|Secondary|Secondary Safety #5 - Percentage of Subjects With Target Vessel Revascularization (TVR) at 6 Months.|Percentage of subjects with Target Vessel Revascularization (TVR) at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679273|NCT01412541|Secondary|Secondary Safety #5 - Percentage of Subjects With Target Vessel Revascularization (TVR) at 1 Month.|Percentage of subjects with Target Vessel Revascularization (TVR) at 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679274|NCT01412541|Secondary|Secondary Safety #4 - Percentage of Subjects With Amputation (Above the Ankle)-Free Survival (AFS) 12 Months.|Percentage of subjects with Amputation (above the ankle)-Free Survival (AFS) 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participans||95% Confidence Interval|Number
2679275|NCT01412541|Secondary|Secondary Safety #4 - Percentage of Subjects With Amputation (Above the Ankle)-Free Survival (AFS) 6 Months.|Percentage of subjects with Amputation (above the ankle)-Free Survival (AFS) 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of partiipants||95% Confidence Interval|Number
2679276|NCT01412541|Secondary|Secondary Safety #4 - Percentage of Subjects With Amputation (Above the Ankle)-Free Survival (AFS) 1 Month.|Percentage of subjects with Amputation (above the ankle)-Free Survival (AFS) 1 Month|1 Month|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679277|NCT01412541|Secondary|Secondary Safety #3 - Percentage of Subjects With All-cause Death at 12 Months.|Percentage of subjects with All-cause death at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679278|NCT01412541|Secondary|Secondary Safety #3 - Percentage of Subjects With All-cause Death at 6 Months.|Percentage of subjects with All-cause death at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679279|NCT01412541|Secondary|Secondary Safety #3 - Percentage of Subjects With All-cause Death at 1 Month.|Percentage of subjects with All-cause death at 1 Month|1 month|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679280|NCT01412541|Secondary|Secondary Safety #2 - Percentage of Subjects With Composite of Freedom From All-cause Perioperative (≤30 Day) Death and Freedom From the Following at 6 Months: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death.|Percentage of subjects with Composite of freedom from all-cause perioperative (≤30 day) death and freedom from the following at 6 months: index limb amputation, index limb re-intervention, and index-limb-related death.|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of Participants||95% Confidence Interval|Number
2679281|NCT01412541|Secondary|Secondary Safety #2 - Percentage of Subjects With Composite of Freedom From All-cause Perioperative (≤30 Day) Death and Freedom From the Following at 1 Month: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death at 1 Month.|Percentage of subjects with Composite of freedom from all-cause perioperative (≤30 day) death and freedom from the following at 1 Month: index limb amputation, index limb re-intervention, and index-limb-related death at 1 month.|1 Month|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of Participants||95% Confidence Interval|Number
2679282|NCT01412541|Secondary|Secondary Safety #1 - Percentage of Subjects With Freedom From All-cause Death, Index Limb Amputation Above the Ankle and Target Vessel Revascularization (TVR) (VIVA Safety Endpoint).|Percentage of subjects with Freedom from all-cause death, index limb amputation above the ankle and Target Vessel Revascularization (TVR) (VIVA Safety Endpoint)|30 days|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679283|NCT01412541|Secondary|Secondary Efficacy #10A - Mean Change in Quality of Life Physical Component and Mental Component of SF-36 v2 From Baseline to 12 Months.|Mean change in quality of life physical component and mental component of SF-36 v2 from baseline to 12 months. The SF-36 v2 United States (US) average normative score is 50, scores can range from 30 (Worst) to 70 (Best).|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||units on a scale||Standard Deviation|Mean
2679284|NCT01412541|Secondary|Secondary Efficacy #10A - Mean Change in Quality of Life Physical and Mental Component of SF-36 v2 From Baseline to 6 Months.|Mean change in quality of life physical and mental component of SF-36 v2 from baseline to 6 months. The SF-36 v2 United States (US) average normative score is 50, scores can range from 30 (Worst) to 70 (Best).|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||units on a scale||Standard Deviation|Mean
2679285|NCT01412541|Secondary|Secondary Efficacy #10 - Mean Change of the EuorQol (EQ-5D) Index From Baseline to 12 Months.|Mean change of the EuorQol (EQ-5D) index from baseline to 12 months. The EQ-5D index range is 0 to 1.0 with a positive change indicating improvment in health state.|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||units on a scale||Standard Deviation|Mean
2679286|NCT01412541|Secondary|Secondary Efficacy #10 - Mean Change of the EuorQol (EQ-5D) Index From Baseline to 6 Months.|Mean change of the EuorQol (EQ-5D) index from baseline to 6 months. The EQ-5D index range is 0 to 1.0 with a positive change indicating improvment in health state.|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||units on a scale||Standard Deviation|Mean
2679287|NCT01412541|Secondary|Secondary Efficacy #9 - Mean of Subjects With Change in Six Minute Walk Test Distance From Baseline Through 12 Months.|Mean of subjects with change in Six Minute Walk Test distance from baseline through 12 months|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||meters||Standard Deviation|Mean
2679288|NCT01412541|Secondary|Secondary Efficacy #9 - Mean of Subjects With Change in Six Minute Walk Test Distance From Baseline to 6 Months.|Mean of subjects with change in Six Minute Walk Test distance from baseline to 6 months|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||meters||Standard Deviation|Mean
2679289|NCT01412541|Secondary|Secondary Efficacy #8 - Mean Differences Between the Total Walking Impairment Questionnaire Score From Baseline to 12 Months.|Mean differences between the total Walking Impairment Questionnaire score from baseline to 12 months. The total score is calculated as the mean of the distance, speed, and stair scores with a range between 0 to 100. A positive change would indicate improvment.|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||units on a scale||Standard Deviation|Mean
2679290|NCT01412541|Secondary|Secondary Efficacy #8 - Mean Differences Between the Total Walking Impairment Questionnaire Score From Baseline to 6 Months.|Mean differences between the total Walking Impairment Questionnaire score from baseline to 6 months. The total score is calculated as the mean of the distance, speed, and stair scores with a range between 0 to 100. A positive change would indicate improvment.|Baseline and 6 months|The sample size were subjects that had data available for analysis of the endpoint.|||units on a scale||Standard Deviation|Mean
2679291|NCT01412541|Secondary|Secondary Efficacy #7 - Mean Difference Between the Baseline and 12 Months of Resting Ankle Brachial Index (ABI).|Mean difference between the baseline and 12 months of resting ankle brachial index (ABI).|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||ratio||Standard Deviation|Mean
2679292|NCT01412541|Secondary|Secondary Efficacy #7 - Mean Difference Between the Baseline and 6 Months of Resting Ankle Brachial Index (ABI).|Mean difference between the baseline and 6 months of resting ankle brachial index (ABI).|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||ratio||Standard Deviation|Mean
2679293|NCT01412541|Secondary|Secondary Efficacy #6 - Percentage of Subjects With Change of Rutherford Classification From Baseline to 12 Months.|Percentage of subjects with change of Rutherford classification from baseline to 12 months Rutherford 0 Asymptomatic, no hemodynamically significant occlusive disease Rutherford 1 Mild claudication Rutherford 2 Moderate claudication Rutherford 3 Severe claudication Rutherford 4 Ischemic rest pain|Baseline and 12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants improving|||Number
2679294|NCT01412541|Secondary|Secondary Efficacy #6 - Percentage of Subjects With Change of Rutherford Classification From Baseline to 6 Months (%Improved).|"Percentage of subjects with change of Rutherford classification from baseline to 6 months (%Improved).~Rutherford 0 Asymptomatic, no hemodynamically significant occlusive disease Rutherford 1 Mild claudication Rutherford 2 Moderate claudication Rutherford 3 Severe claudication Rutherford 4 Ischemic rest pain"|Baseline and 6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants improving|||Number
2679295|NCT01412541|Secondary|Secondary Efficacy #5A - Percentage of Subjects With Freedom From Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - Driven) at 12 Months.|Percentage of subjects with Freedom from Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - driven) at 12 Months|12 Month|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679296|NCT01412541|Secondary|Secondary Efficacy #5A - Percentage of Subjects With Freedom From Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - Driven) at 6 Months.|Percentage of subjects with Freedom from Target Lesion Revascularization (TLR) Total (Clinical and DUS/Angiography - driven) at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679297|NCT01412541|Secondary|Secondary Efficacy #5 - Percentage of Subjects With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 12 Months.|Percentage of subjects with Freedom from Target Lesion Revascularization (TLR) Clinically-driven at 12 Months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of partcipants||95% Confidence Interval|Number
2679298|NCT01412541|Secondary|Secondary Efficacy #5 - Percentage of Subject With Freedom From Target Lesion Revascularization (TLR) Clinically-driven at 6 Months.|Percentage of subject with Freedom from Target Lesion Revascularization (TLR) Clinically-driven at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679378|NCT01412021|Primary|Change From Baseline in Physician Global Assessment (VAS) at Week 8|A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.|Baseline, Week 8|participants in the efficacy analysis set with an assessment|||mm||Standard Deviation|Mean
2679299|NCT01412541|Secondary|Secondary Efficacy #4 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) <2.5 Through 12 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) <2.5 through 12 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679300|NCT01412541|Secondary|Secondary Efficacy #4 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Suplex Ultrasound (DUS) Peak Systolic Velocity Ration (PSVR) <2.5 Through 6 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of Suplex Ultrasound (DUS) peak systolic velocity ration (PSVR) <2.5 through 6 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679301|NCT01412541|Secondary|Secondary Efficacy #3A - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ration (PSVR) <3.0 Through 12 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of Duplex Ultrasound (DUS) peak systolic velocity ration (PSVR) <3.0 through 12 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679302|NCT01412541|Secondary|Secondary Efficacy #3A - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) <3.0 Through 6 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) <3.0 through 6 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679303|NCT01412541|Secondary|Secondary Efficacy #3 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) <2.0 Through 12 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) <2.0 through 12 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679304|NCT01412541|Secondary|Secondary Efficacy #3 - Percentage of Subjects With Alternative Primary Patency Based on Alternative Definitions of Duplex Ultrasound Peak Systolic Velocity Ratio (DUS PSVR) <2.0 Through 6 Months.|Percentage of subjects with Alternative Primary Patency based on alternative definitions of duplex ultrasound peak systolic velocity ratio (DUS PSVR) <2.0 through 6 Months. DUS PSVR is calculated by dividing the maximum peak systolic velocity (PSV) from the stenosis by the PSV from the nearest segment of normal artery above the site of increase.|6 Months|.The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679305|NCT01412541|Secondary|Secondary Efficacy #2A - Percentage of Subjects With Secondary Patency Rate at 12 Months (Defined by Core Lab Adjudication).|Percentage of subjects with Secondary Patency Rate at 12 Months (defined by core lab adjudication)|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679306|NCT01412541|Secondary|Secondary Efficacy #2A - Percentage of Subjects With Secondary Patency (Absence of Target Lesion Restenosis by Core Lab Adjudication) at 6 Months.|Percentage of subjects with Secondary Patency (absence of target lesion restenosis by core lab adjudication) at 6 Months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of Participants||95% Confidence Interval|Number
2679307|NCT01412541|Secondary|Secondary Efficacy #2 - Percentage of Subjects With Duplex Ultrasound Clinical Primary Patency [Freedom From Clinically Driven Target Lesion Revascularization (TLR) and Binary Restenosis] at 12 Months.|Percentage of subjects with duplex ultrasound Clinical Primary Patency [Freedom from Clinically Driven Target Lesion Revascularization (TLR) and binary restenosis] at 12 months|12 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679308|NCT01412541|Secondary|Secondary Efficacy #2 - Percentage of Subjects With Duplex Ultrasound Clinical Primary Patency [Freedom From Clinically Driven Target Lesion Revascularization (TLR) and Binary Restenosis] at 6 Months.|Percentage of subjects with Duplex Ultrasound Clinical Primary Patency [Freedom from Clinically Driven Target Lesion Revascularization (TLR) and binary restenosis] at 6 months|6 Months|The sample size were subjects that had data available for analysis of the endpoint.|||percentage of participants||95% Confidence Interval|Number
2679309|NCT01412541|Secondary|Secondary Efficacy #1B - Number of Subjects With Procedural Success.|Number of subjects with Procedural Success defined as attainment of ≤30% residual stenosis in the treatment area by independent core lab analysis without serious adverse events during the index procedure.|During the procedure|Based on number of subjects with Procedural success as identified by the core lab.|||participants|||Number
2679310|NCT01412541|Secondary|Secondary Efficacy #1A - Number of Subjects With Technical Success.|Number of subjects with Technical Success defined as successful access and deployment of the device and visual estimate of ≤30% diameter residual stenosis during the index procedure without deployment of a bailout stent.|During the procedure|Based on number of subjects with Technical success as identified by the core lab.|||participants|||Number
2679680|NCT01410110|Primary|Days of Use in Prior 30 Days|Days of Use based on Time-Line Follow-back, Toxicology Screen, Breathalyzer, and Chart Review. The range at 6 month follow-up is 0 to 30 days of use with more days being a worse outcome.|30 Days Prior to 6 month follow-up||||Days of Use||Standard Deviation|Mean
2679311|NCT01412541|Secondary|Secondary Efficacy #1 - Number of Devices With Device Success.|Number of devices with Device Success defined on a per device basis, the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system.|During the procedure|Based upon devices used in the study (432 for DCB and 180 for PTA).|||devices|Devices||Number
2679312|NCT01412541|Primary|Primary Efficacy - Percentage of Subjects With Primary Patency of the Target Lesion at One Year.|Percentage of subjects with Primary patency of the target lesion at one year. Primary patency is defined as freedom from target lesion restenosis (defined by duplex ultrasound core lab adjudication) and target lesion revascularization (TLR).|12 months|Overall, 83.5% (264/316) test DCB subjects and 84.4% (135/160) control PTA subjects were evaluable for the primary efficacy endpoint testing.|||percentage of participants||95% Confidence Interval|Number
2679313|NCT01412541|Primary|Primary Safety - Percentage of Subjects With Composite of Freedom From All-cause Peri-operative (≤30 Day) Death and Freedom From the Following: Index Limb Amputation, Index Limb Re-intervention, and Index-limb-related Death at 12 Months.|Percentage of subjects with Composite of freedom from all-cause peri-operative (≤30 day) death and freedom from the following: index limb amputation, index limb re-intervention, and index-limb-related death at 12 months.|12 months|Overall, 90.5% (286/316) test DCB subjects and 89.4% (143/160) control PTA subjects were evaluable for primary safety endpoint testing.|||percentage of participants||95% Confidence Interval|Number
2679314|NCT01412424|Secondary|Percentage of Participants With ≥ 1, 2, or 3 Acromegaly Symptoms at Baseline and at the End of the Extension Treatment Period|Reported is the percentage of participants who had ≥ 1, 2, or 3 of the 5 symptoms of acromegaly (headaches, perspiration, asthenia, swelling of extremities, or joint pain) of any severity (mild, moderate, or severe). This was a post hoc analysis.|Baseline and the end of the extension treatment period (up to 13 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.|||Percentage of participants|||Number
2679315|NCT01412424|Secondary|Percentage of Participants With Improved or Maintained Acromegaly Symptoms at the End of the Extension Treatment Period|The severity (absent, mild, moderate, severe) of the 5 acromegaly symptoms headache, perspiration, asthenia, swelling of extremities, and joint pain was assessed at Baseline and at the end of the extension treatment period. The percentage of participants with improved or maintained (no change) acromegaly symptoms from Baseline at the end of the extension treatment period is reported.|Baseline and the end of the extension treatment period (up to 13 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.|||Percentage of participants||95% Confidence Interval|Number
2679316|NCT01412424|Secondary|Maintenance of Response During the Extension Treatment Period|Maintenance of an insulin-like growth factor-1 (IGF-1) response during the extension treatment period was defined as the percentage of participants with an IGF-1 concentration < 1.3 times the upper limit of normal at the beginning of the extension treatment period and at the end of the extension treatment period. IGF-1 concentration was determined in serum samples taken at the same visits growth hormone concentration was assessed.|Beginning of the extension treatment period and the end of the extension treatment period (up to 13 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.|||Percentage of participants||95% Confidence Interval|Number
2679317|NCT01412424|Secondary|Percentage of Participants With Specified IGF-1 and GH Concentrations at the Beginning and at the End of the Extension Treatment Period|Percentage of participants with the following serum insulin-like growth factor-1 (IGF-1) and growth hormone (GH) concentrations at the beginning (BETP) and at the end (EETP) of the extension treatment period: IGF-1 < 1.3 times the upper level of normal (ULN) and GH < 5.0 ng/mL, IGF-1 < 1.3 times ULN and GH < 1.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 5.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 2.5 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 1.0 ng/mL, IGF-1 < 1.3 times ULN, IGF-1 ≤ 1.0 times ULN, GH < 5.0 ng/mL, GH < 2.5 ng/mL, GH < 1.0 ng/mL, IGF-1 ≥ 1.3 times ULN and GH < 2.5 ng/mL, IGF-1 < 1.3 times ULN and GH ≥ 2.5 ng/mL, and IGF-1 ≥ 1.3 times ULN and GH ≥ 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.|Beginning and the end of the extension treatment period (up to 6 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.|||Percentage of participants|||Number
2679318|NCT01412424|Secondary|Maintenance of Response During the Fixed Dose Phase of the Core Treatment Period|Maintenance of response during the fixed dose phase of the core treatment period was defined as the percentage of participants with an insulin-like growth factor-1 (IGF-1) concentration < 1.3 times the upper limit of normal at the beginning of the fixed dose phase of the core treatment period and at the end of the core treatment period. IGF-1 concentration was determined in serum samples taken at the same visits growth hormone concentration was assessed.|Beginning of the fixed dose phase of the core treatment period and the end of the core treatment period (up to 7 months)|Fixed dose population: All enrolled participants who received any amount of study drug, who had at least 1 IGF-1 or GH assessment after the first dose of octreotide, and who entered the fixed dose phase of the core treatment period.|||Percentage of participants|||Number
2679336|NCT01412281|Secondary|Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability|"Solicited local and systemic AEs, Unsolicited AEs, Tolerability and acceptability~Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).~Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4"|Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days)|Safety population, all vaccinated subjects|||participants|||Number
2679338|NCT01412281|Primary|Seroprotection|"Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers|||percentage of seroprotected subjects||95% Confidence Interval|Number
2679319|NCT01412424|Secondary|Percentage of Participants With Specified IGF-1 and GH Concentrations at Baseline and at the End of the Core Treatment Period|Percentage of participants with the following serum insulin-like growth factor-1 (IGF-1) and growth hormone (GH) concentrations at Baseline and at the end of the core treatment period (ECTP): IGF-1 < 1.3 times the upper limit of normal (ULN) and GH < 5.0 ng/mL, IGF-1 < 1.3 times ULN and GH < 1.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 5.0 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 2.5 ng/mL, IGF-1 ≤ 1.0 times ULN and GH < 1.0 ng/mL, IGF-1 < 1.3 times ULN, IGF-1 ≤ 1.0 times ULN, GH < 5.0 ng/mL, GH < 2.5 ng/mL, GH < 1.0 ng/mL, IGF-1 ≥ 1.3 times ULN and GH < 2.5 ng/mL, IGF-1 < 1.3 times ULN and GH ≥ 2.5 ng/mL, and IGF-1 ≥ 1.3 times ULN and GH ≥ 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.|Baseline and the end of the core treatment period (up to 7 months)|Modified intent-to-treat population: All enrolled participants who received any amount of study drug and who had at least 1 IGF-1 or GH assessment after the first dose of octreotide.|||Percentage of participants|||Number
2679320|NCT01412424|Primary|Percentage of Responders at the End of the Extension Treatment Period|A responder was defined as a participant with a serum insulin-like growth factor-1 (IGF-1) concentration < 1.3 times the upper limit of normal (adjusted for age and gender) and a growth hormone (GH) concentration < 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.|End of the extension treatment period (up to 13 months)|Extension intent-to-treat population: All participants who entered the extension treatment period and received any amount of study drug during the extension treatment period.|||Percentage of responders||95% Confidence Interval|Number
2679321|NCT01412424|Primary|Percentage of Responders at the End of the Core Treatment Period|A responder was defined as a participant with a serum insulin-like growth factor-1 (IGF-1) concentration < 1.3 times the upper limit of normal (adjusted for age and gender) and a growth hormone (GH) concentration < 2.5 ng/mL. The growth hormone concentration was the mean of 5 fasted GH serum concentrations collected at 30 minute intervals for 2 hours, 2 to 4 hours post-octreotide dose. IGF-1 concentration was determined in serum samples taken at the same visits GH concentration was assessed.|End of the core treatment period (up to 7 months)|Modified intent-to-treat population: All enrolled participants who received any amount of study drug and who had at least 1 IGF-1 or GH assessment after the first dose of octreotide.|||Percentage of responders||95% Confidence Interval|Number
2679322|NCT01412333|Secondary|Number of Participants With Anti-Drug Antibodies (ADAs) to Ocrelizumab|Number of participants positive for anti-drug antibodies (ADAs) to ocrelizumab is the number of post- baseline evaluable participants determined to have treatment-induced ADA or treatment-enhanced ADA during the study period.|Baseline up to Week 96|Baseline evaluable participants with an ADA assay result from a baseline sample(s). The safety population included all participants who received any study drug. Here, n signifies the number of participants evaluable at the specified time points.|||participants|||Number
2679323|NCT01412333|Secondary|Exposure to Ocrelizumab (Area Under the Concentration - Time Curve, AUC)|AUC represents total drug exposure for one dosing interval after the 4th dose.|Pre-infusion at Weeks 1, 24, 48, 72; and 30 minutes post-infusion at Week 72; at any time during Weeks 84 and 96|The pharmacokinetics (PK) population included all participants in the ocrelizumab group who had at least 1 measurable concentration value.|||micrograms per milliter*day||Standard Deviation|Mean
2679324|NCT01412333|Secondary|Number of Participants With Adverse Events (AEs)|AEs included infusion related reactions (IRRs) and serious MS relapses, but excluded non-serious MS relapses. Serious Adverse Events (SAEs) included serious MS relapses and serious IRRs.|Baseline up to Week 96|The safety population included all participants who received any study drug.|||participants|||Number
2679325|NCT01412333|Secondary|Percentage of Participants Who Have No Evidence of Disease Activity (NEDA) up to Week 96|NEDA was defined only for participants with a baseline EDSS score >=2.0. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). Participants who completed the 96- week treatment period were considered as having evidence of disease activity if at least one protocol- defined relapse (PDR), a confirmed disability progression (CDP) event or at least one MRI scan showing MRI activity (defined as Gd-enhancing T1 lesions, or new or enlarging T2 lesions) was reported during the 96-week treatment period, otherwise the participant was considered as having NEDA.|Week 96|ITT population included all randomized participants in the study. Here, number of participants analysed signifies number of participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2679326|NCT01412333|Secondary|Change From Baseline in Short Form Health Survey-36 (SF-36) Physical Component Summary (PCS) Score at Week 96|The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores (domains) as well as psychometrically based physical and mental health summary measures. The SF-36 taps 8 health concepts: physical functioning, bodily pain, physical role functioning, emotional role functioning, emotional well-being, social functioning, vitality, and general health perceptions. The 8 scales are further summarized to 2 distinct higher-ordered clusters: the PCS and mental composite t-score (MCS). The range for all 8 domains as well as for the composite t- scores is from 0 to 100 with 100 as best possible health status and 0 as worst health status.|Baseline, Week 96|Descriptive statistics at baseline include participants with assessment at baseline and at least one post- baseline value. ITT population included all randomized participants in the study. Here, n signifies the number of participants evaluable at specified time points.|||t-score||Standard Error|Mean
2679337|NCT01412281|Primary|Seroconversion|"Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat population, vaccinated subjects with available pre- and post-vaccination titers|||percentage of seroconverted subjects||95% Confidence Interval|Number
2679359|NCT01412151|Primary|Tolerability|Proportion of subjects able to complete treatment|306 Weeks||||Participants|||Number
2679327|NCT01412333|Secondary|Percent Change in Brain Volume as Detected by Brain Magnetic Resonance Imaging (MRI) From Week 24 to Week 96|"Brain volume was recorded as an absolute normalized value at the baseline visit then recorded at subsequent visits as a percentage change relative to the absolute value at the baseline visit. Therefore, brain volume at Week 24 was calculated as the brain volume at the baseline visit multiplied by 1 + ([percentage change in brain volume from baseline visit to Week 24]/100). Estimates are from analysis based on mixed-effect model of repeated measures (MMRM) using unstructured covariance matrix: Percentage Change = Brain Volume at Week 24 + Geographical Region (US vs. ROW) + Baseline EDSS (< 4.0 vs. >= 4.0) + Week + Treatment + Treatment*Week (repeated values over Week) + Brain Volume at Week 24*Week. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis)."|From week 24 up to week 96|ITT population included all randomized participants in the study. Here, number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||percent change||Standard Error|Mean
2679328|NCT01412333|Secondary|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Score to Week 96|MSFC score consists of: A) Timed 25-Foot walk; B) 9-Hole Peg Test (9-HPT); and C) Paced Auditory Serial Addition Test (PASAT-3 version). The MSFCS is based on the concept that scores for these three dimensions (arm, leg, and cognitive function) are combined to create a single score (the MSFC) that can be used to detect change over time in a group of participants with MS. Since the three primary measures differ in what they actually measure, a common composite score for the three different measures i.e., Z- score was selected for the purpose. MSFC Score = {Z arm, average + Z leg, average + Z cognitive} / 3.0. The results from each of these three tests are transformed into Z-scores and averaged to yield a composite score for each participant at each time point. A score of +1 indicates that, on average, an individual scored 1 standard deviation (SD) better than the reference population and a score of -1 indicates that an individual scored 1 SD worse than the reference population.|Baseline, Week 96|ITT population included all randomized participants in the study. Here, n signifies the number of participants evaluable at specified time points.|||Z-score||Standard Error|Mean
2679329|NCT01412333|Secondary|Number of T1 Hypointense Lesions During the Double-Blind Treatment|The total number of new T1-Hypo-Intense Lesions (Chronic Black Holes) for all participants in the treatment group was calculated as the sum of the individual number of new lesions at Weeks 24, 48, and 96.|Baseline up to week 96|ITT population included all randomized participants in the study.|||lesions|||Number
2679330|NCT01412333|Secondary|Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks During the Double-Blind Treatment Period|Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 24 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.|Week 104|ITT population included all randomized participants in the study.|||weeks||Full Range|Median
2679331|NCT01412333|Secondary|Percentage of Participants With Confirmed Disability Improvement (CDI) for at Least 12 Weeks|Disability improvement was assessed only for the subgroup of participants with a baseline EDSS score of >= 2.0. It was defined as a reduction in EDSS score of: A) >=1.0 from the baseline EDSS score when the baseline score was >=2 and <=5.5 B) >= 0.5 when the baseline EDSS score > 5.5. The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined.|Week 96|ITT population included all randomized participants in the study. Here, number of participants analyzed signifies number of participants who were evaluable for this outcome measure.|||percentage of participants||95% Confidence Interval|Number
2679332|NCT01412333|Secondary|Number of New, and/or Enlarging T2 Hyperintense Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double Blind Treatment|The total number of new and/or enlarging T2 lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.|Baseline up to week 96|ITT population included all randomized participants in the study.|||lesions|||Number
2679333|NCT01412333|Secondary|Number of T1 Gadolinium (Gd)-Enhancing Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) During the Double-Blind Treatment|The total number of T1 gadolinium-enhancing lesions for all participants in the treatment group was calculated as the sum of the individual number of lesions at Weeks 24, 48, and 96.|Baseline up to week 96|ITT population included all randomized participants in the study.|||lesions|||Number
2679334|NCT01412333|Secondary|Time to Onset of Confirmed Disability Progression (CDP) for at Least 12 Weeks During the Double-Blind Treatment Period|Disability progression was defined as an increase in the Expanded Disability Status Scale (EDSS) score of: A) >=1.0 point from the baseline EDSS score when the baseline score was less than or equal to (<=) 5.5 B) >=0.5 point from the baseline EDSS score when the baseline score was >5.5 The EDSS scale ranges from 0 (normal neurological exam) to 10 (death due to multiple sclerosis). This outcome measure was considered confirmatory only when results of both studies WA21092 and WA21093 were combined. Disability progression was considered confirmed when the increase in the EDSS was confirmed at a regularly scheduled visit at least 12 weeks after the initial documentation of neurological worsening. Participants who had initial disability progression with no confirmatory EDSS assessment and who were on treatment at time of clinical cut-off date were censored at the date of their last EDSS assessment.|Week 104|ITT population included all randomized participants in the study.|||weeks||Full Range|Median
2679335|NCT01412333|Primary|Annualized Relapse Rate (ARR) in Participants With Relapsing Multiple Sclerosis (MS) at 96 Weeks|ARR was protocol-defined and calculated as the total number of relapses for all participants in the treatment group divided by the total participant-years of exposure to that treatment.|Week 96|Intent-to-treat (ITT) population included all randomized participants in the study.|||relapses/participant year of treatment||95% Confidence Interval|Number
2680319|NCT01402115|Secondary|Changes in PTH(Parathyroid Hormone)|PTH(parathyroid hormone) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||pg/mL||Standard Deviation|Mean
2679339|NCT01412281|Primary|Geometric Mean Titer|"GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA Note for guidance on harmonisation of requirements for influenza vaccines, 1997)"|3 weeks after vaccination (Day 22 ± 2 days)|Intent-to-treat, vaccinated subjects with available pre- and post-vaccination titers|||GMT fold increase from baseline||95% Confidence Interval|Number
2679340|NCT01412229|Secondary|Patient-reported Quality of Life Scores|Functional Assessment of Cancer Therapy - Head & Neck (FACT-HN) is the FACT-G and a 12 item head and neck cancer specific subscale completed at screening (Screening), 3 weeks post induction chemotherapy (Treatment Break), 7 weeks post concomitant chemoradiotherapy (7 weeks Off Treatment), one year post off-treatment (1 year Off Treatment). The FACT-G is a 27 item measure of general QOL assessing function in 4 domains: physical well-being (PWB), social-family well-being (SFWB), emotional well-being (EWB) and functional well-being (FWB). Items are rated by patients on a Likert scale from 0 to 4 (resulting in potential total scores between 0 and 156). Higher scores represent better QOL.|screening until one year after treatment|All patients on treatment who returned completed questionnaires at each time point|||FACT-HN score||Full Range|Median
2679341|NCT01412229|Secondary|Number of Participants With at Least One Grade 3-4 Toxicity, Listed by Event|Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.|24 Weeks|Patients who received study treatment|||participants|||Number
2679342|NCT01412229|Secondary|Number of Participants With at Least One Grade 3-4 Toxicity|Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.|9 Weeks|Patients who received treatment on study|||Participants|||Count of Participants
2679343|NCT01412229|Secondary|Overall Survival|Rate of Overall Survival|1 year|Patients who completed treatment|||Participants|||Count of Participants
2679344|NCT01412229|Secondary|Complete Response Rate (CR)|Complete Response Rate as defined by RECIST 1.1 after induction chemotherapy followed by definitive chemoradiation|20 weeks|Patients who completed treatment|||Participants|||Count of Participants
2679345|NCT01412229|Secondary|Objective Response Rate (CR+PR)|Objective Response Rate as defined by RECIST 1.1 after induction chemotherapy followed by definitive chemoradiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|20 weeks|Patients who completed treatment|||Participants|||Count of Participants
2679346|NCT01412229|Secondary|Progression Free Survival|Rate of Progression Free Survival (Time to death or progression defined by imaging of target lesions via CT or MRI scan post induction chemotherapy and chemoradiotherapy every 3 months for one year)|1 year||||percentage of participants||95% Confidence Interval|Number
2679347|NCT01412229|Secondary|Rate of Complete Response Following Induction Chemotherapy|Report the rate of complete responses, defined as disappearance of all target lesions, following induction chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions.|Baseline evaluation to 3 weeks after induction chemotherapy||||Participants|||Count of Participants
2679348|NCT01412229|Primary|Clinical Response Rate Following Induction Chemotherapy|Evaluation of target lesions via imaging with CT or MRI scans at 2-3 weeks post induction chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.|9 weeks||||Participants|||Count of Participants
2679349|NCT01412164|Secondary|TLF (Target Lesion Failure)|Participants with the determination of TLF. TLF is the composite of cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure|5 years after index PCI||||Participants|||Count of Participants
2679350|NCT01412164|Secondary|TLF (Target Lesion Failure)|Participants with the determination of TLF, TLF is the composite of cardiac death, target vessel MI and clinically driven TLR|3 years after index PCI||||Participants|||Count of Participants
2679351|NCT01412164|Secondary|TLF (Target Lesion Failure)|Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR|1 years after index PCI||||percentage of participants with TLF|||Number
2679352|NCT01412164|Secondary|Patient-related Cardiovascular Clinical Composite Endpoints|Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction.|5 years after index PCI||||Participants|||Count of Participants
2679353|NCT01412164|Secondary|Patient-related Cardiovascular Clinical Composite Endpoints|Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction.|3 years after index PCI||||Participants|||Count of Participants
2679354|NCT01412164|Secondary|Patient-related Cardiovascular Clinical Composite Endpoints|Participants with cardiovascular clinical composite endpoints. Cardiovascular clinical composite endpoints defined as the composite of all death, all MI and vascular reconstruction.|1 years after index PCI||||Participants|||Count of Participants
2679355|NCT01412164|Secondary|Stent Implantation Success Rate (SIS Rate)|Stent implantation success (SIS) means participant successfully implanted stent, defined as residual stenosis of the lesion less than 30% and TIMI bloodflow Grade III|immediately after the procedure||||percentage of participants with SIS|||Number
2679356|NCT01412164|Primary|TLF (Target Lesion Failure) Rate|Percentage of participants with determination of TLF ,TLF is the composite of cardiac death, target vessel MI and clinically driven TLR|12 months after index procedure||||percentage of participants with TLF|||Number
2679357|NCT01412151|Secondary|Biological Markers of Disease Progression|Biological indicators that creatine treatment might affect the progression of HD: serum creatine levels, neuroimaging, metabolomic and gene expression analysis|310 Weeks|data was not collected or analyzed for this outcome measure.||||||
2679358|NCT01412151|Secondary|Clinical Measures Resources Not Available to Complete Secondary Analyses.|"Components of the UHDRS (Unified Huntington Disease Rating Scale)~data was not collected or analyzed for this outcome measure."|310 Weeks|data was not collected or analyzed for this outcome measure.||||||
2679360|NCT01412086|Primary|Intra-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale|Intra-rater (within raters) agreement of the GEBA scores (1=very sparse, 2=sparse, 3=full, 4=very full) to assess eyebrow fullness was evaluated by weighted Kappa statistics. Weighted Kappa statistics were calculated for each of 7 raters who evaluated 112 subjects using GEBA scale, assessing agreement between 2 different time points at day 1. The overall intra-rater agreement for Kappa statistics for all raters combined was estimated by pooling Kappa statistics for each rater using a chi-square statistic. The degree of agreement of the point estimates of Kappa statistics was interpreted according to the reference range scale that was predefined as: ≤ 0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial and 0.81-1:00: almost perfect. The 95% confidence interval for Kappa statistics was provided.|Day 1|All enrolled participants.|||Kappa statistics||95% Confidence Interval|Number
2679361|NCT01412086|Primary|Inter-rater Reliability of Physician Raters Using the Global Eyebrow Assessment (GEBA) Scale|Inter-rater agreement (among raters) of the GEBA scores (1=very sparse, 2=sparse, 3=full, 4=very full) to assess eyebrow fullness was evaluated using Kendall's coefficient of concordance (Kendall's W). Each of 7 raters scored 112 subjects' eyebrows using the GEBA Scale at 2 different time points at day 1. The overall inter-rater agreement for Kendall's W for all raters combined was estimated based on the average of the scores from those 2 different time points. The degree of agreement of the point estimates of Kendall's W was interpreted according to the reference range scale that was pre-defined as: ≤ 0: poor, 0.00-0.20: slightly, 0.21-0.40: fair, 0.41-0.60: moderate, 0.61-0.80: substantial and 0.81-1:00: almost perfect. The 95% confidence interval for Kendall's W was provided.|Day 1||||Kendall's W||95% Confidence Interval|Number
2679362|NCT01412060|Primary|Time From Baseline to the First Symptom Relapse During the Double-blind Phase|"Relapse was defined as meeting ≥1 of the following criteria:1-Hospitalization due to worsening of condition;2-increase in Positive and Negative Syndrome Scale(PANSS) total score by ≥30% for participants,scored ≥50 or a ≥10-point increase for participants,scored <50 at randomization;3-increase in Clinical Global Impressions-Severity(CGI-S) score by ≥2 points at Week 20;4-deliberate self-injury or aggressive behaviour;5-suicidal/homicidal ideation judged clinically significant by Investigator;6-score of >4 on 1 or more of following PANSS items:P1,P2,P3,P6,P7,G8 or G14. Second assessment not performed based on Investigator discretion.~PANSS is 30-item rating scale. Each item scored on 7-point scale. Total score ranges from 30 to 210. Lower score indicates fewer schizophrenic symptoms. CGI-S is 7-point scale,measures severity of participant's illness in comparison with others with same diagnosis. Lower score indicates less severe illness. 25th percentile for time to relapse was reported."|Up to 34 Weeks and Bi-Weekly thereafter until Week 92|Double-blind intent-to-treat population: All participants who received at least 1 dose of double-blind investigational product and who had at least 1 post-randomization assessment of PANSS or CGI-S during the Double-blind Treatment Phase.|||Days||95% Confidence Interval|Number
2679363|NCT01412021|Other Pre-specified|Number of Participants With Adverse Drug Reactions (ADRs)|Adverse drug reactions are defined and totaled as collected adverse events whose causal relation with adalimumab cannot be ruled out. An adverse event refers to any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease associated with the use of a drug, whether or not considered related to the drug.|up to Week 24|participants in the safety analysis set with an assessment|||Participants|||Count of Participants
2679364|NCT01412021|Primary|Change From Baseline in Weight at Week 24||Baseline, Week 24|participants in the safety analysis set with an assessment|||kg||Standard Deviation|Mean
2679365|NCT01412021|Primary|Change From Baseline in Weight at Week 16||Baseline, Week 16|participants in the safety analysis set with an assessment|||kg||Standard Deviation|Mean
2679366|NCT01412021|Primary|Change From Baseline in Weight at Week 12||Baseline, Week 12|participants in the safety analysis set with an assessment|||kg||Standard Deviation|Mean
2679367|NCT01412021|Primary|Change From Baseline in Weight at Week 8||Baseline, Week 8|participants in the safety analysis set with an assessment|||kg||Standard Deviation|Mean
2679368|NCT01412021|Primary|Change From Baseline in Weight at Week 4||Baseline, Week 4|participants in the safety analysis set with an assessment|||kg||Standard Deviation|Mean
2679369|NCT01412021|Primary|Change From Baseline in Height at Week 24||Baseline, Week 24|participants in the safety analysis set with an assessment|||cm||Standard Deviation|Mean
2679370|NCT01412021|Primary|Change From Baseline in Height at Week 16||Baseline, Week 16|participants in the safety analysis set with an assessment|||cm||Standard Deviation|Mean
2679371|NCT01412021|Primary|Change From Baseline in Height at Week 12||Baseline, Week 12|participants in the safety analysis set with an assessment|||cm||Standard Deviation|Mean
2679372|NCT01412021|Primary|Change From Baseline in Height at Week 8||Baseline, Week 8|participants in the safety analysis set with an assessment|||cm||Standard Deviation|Mean
2679373|NCT01412021|Primary|Change From Baseline in Height at Week 4||Baseline, Week 4|participants in the safety analysis set with an assessment|||cm||Standard Deviation|Mean
2679374|NCT01412021|Primary|Change From Baseline in Anti-Cyclic Citrullinated Peptide Antibodies at Week 24||Baseline, Week 24|participants in the efficacy analysis set with an assessment|||U/mL||Standard Deviation|Mean
2679375|NCT01412021|Primary|Change From Baseline in Physician Global Assessment (VAS) at Week 24|A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.|Baseline, Week 24|participants in the efficacy analysis set with an assessment|||mm||Standard Deviation|Mean
2679376|NCT01412021|Primary|Change From Baseline in Physician Global Assessment (VAS) at Week 16|A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.|Baseline, Week 16|participants in the efficacy analysis set with an assessment|||mm||Standard Deviation|Mean
2679377|NCT01412021|Primary|Change From Baseline in Physician Global Assessment (VAS) at Week 12|A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.|Baseline, Week 12|participants in the efficacy analysis set with an assessment|||mm||Standard Deviation|Mean
2679379|NCT01412021|Primary|Change From Baseline in Physician Global Assessment (VAS) at Week 4|A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.|Baseline, Week 4|participants in the efficacy analysis set with an assessment|||mm||Standard Deviation|Mean
2679380|NCT01412021|Primary|Change From Baseline in Serum MMP3 Level at Week 24||Baseline, Week 24|participants in the efficacy analysis set with an assessment|||ng/mL||Standard Deviation|Mean
2679381|NCT01412021|Primary|Change From Baseline in Serum MMP3 Level at Week 16||Baseline, Week 16|participants in the efficacy analysis set with an assessment|||ng/mL||Standard Deviation|Mean
2679382|NCT01412021|Primary|Change From Baseline in Serum MMP3 Level at Week 12||Baseline, Week 12|participants in the efficacy analysis set with an assessment|||ng/mL||Standard Deviation|Mean
2679383|NCT01412021|Primary|Change From Baseline in Serum MMP3 Level at Week 8||Baseline, Week 8|participants in the efficacy analysis set with an assessment|||ng/mL||Standard Deviation|Mean
2679384|NCT01412021|Primary|Change From Baseline in Serum MMP3 Level at Week 4||Baseline, Week 4|participants in the efficacy analysis set with an assessment|||ng/mL||Standard Deviation|Mean
2679385|NCT01412021|Primary|Change From Baseline in DAS28-4/CRP at Week 24|The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline, Week 24|participants in the efficacy analysis set with an assessment|||units on a scale||Standard Deviation|Mean
2679386|NCT01412021|Primary|Change From Baseline in DAS28-4/CRP at Week 16|The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline, Week 16|participants in the efficacy analysis set with an assessment|||units on a scale||Standard Deviation|Mean
2679387|NCT01412021|Primary|Change From Baseline in DAS28-4/CRP at Week 12|The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline, Week 12|participants in the efficacy analysis set with an assessment|||units on a scale||Standard Deviation|Mean
2679388|NCT01412021|Primary|Change From Baseline in DAS28-4/CRP at Week 8|The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline, Week 8|participants in the efficacy analysis set with an assessment|||units on a scale||Standard Deviation|Mean
2679389|NCT01412021|Primary|Change From Baseline in DAS28-4/CRP at Week 4|The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline, Week 4|participants in the efficacy analysis set with an assessment|||units on a scale||Standard Deviation|Mean
2679390|NCT01412021|Primary|Change From Baseline in DAS28-4/ESR at Week 24|The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline, Week 24|participants in the efficacy analysis set with an assessment|||units on a scale||Standard Deviation|Mean
2679391|NCT01412021|Primary|Change From Baseline in DAS28-4/ESR at Week 16|The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline, Week 16|participants in the efficacy analysis set with an assessment|||units on a scale||Standard Deviation|Mean
2679392|NCT01412021|Primary|Change From Baseline in DAS28-4/ESR at Week 12|The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline, Week 12|participants in the efficacy analysis set with an assessment|||units on a scale||Standard Deviation|Mean
2679412|NCT01411852|Secondary|"Acute Renal Failure Classification Score of Failure Without Glomerular Filtration Rate (GFR)"|Increased plasma creatinine > 3 x reference measure (ED admission) or acute plasma creatinine = 350 umol/L or acute rise = 44 umol/L or urine output < 0.3 mL/k/h x 24h. Only measured for patients with at least 2 days of ICU stay assessed.|From ED arrival through the first 24 hours|Patients with at least at 2 day stay in the ICU|||participants|||Number
2679393|NCT01412021|Primary|Change From Baseline in DAS28-4/ESR at Week 8|The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline, Week 8|participants in the efficacy analysis set with an assessment|||units on a scale||Standard Deviation|Mean
2679394|NCT01412021|Primary|Change From Baseline in DAS28-4/ESR at Week 4|The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.|Baseline, Week 4|participants in the efficacy analysis set with an assessment|||units on a scale||Standard Deviation|Mean
2679395|NCT01411995|Primary|Pain Score Assessed Immediately Following IUD Insertion|"Using a visual analog scale, women will report their level of pain pre-procedure, after tenaculum placement, and post-procedure (following IUD insertion).The entirety of the procedure should last no more than 5-10 minutes. The pain score is assessed at the 3 timepoints within that 10 minute window. No additional followup is required.~Range: 0-10 (0= no pain, 10=worst pain)"|Immediately following IUD insertion||||units on visual analog scale||Full Range|Median
2679396|NCT01411917|Secondary|Time to Hospital Discharge|This outcome is intended to assess the impact of the regional anesthesia technique on the amount of time that patients stayed in the hospital following their surgical procedure. This outcome is measured in hours.|Hours that patient spends in the hospital for their surgical procedure.||||hours||Standard Deviation|Mean
2679397|NCT01411917|Secondary|Incidence of Post-operative Nausea||24 hours||||Participants|||Count of Participants
2679398|NCT01411917|Secondary|PACU Opioid Use|Morphine Equivalents|Approximately two hours post-anesthesia||||mg||Standard Deviation|Mean
2679399|NCT01411917|Secondary|Intra-operative Opioid Use|Morphine Equivalents|Approximately 2-3 hours after block/placebo placement||||mg||Standard Deviation|Mean
2679400|NCT01411917|Secondary|Time From PACU Recovery Room Admission Until Meeting Recovery Room Discharge Criteria||Approximately two hours post-anesthesia||||Minutes||Standard Deviation|Mean
2679401|NCT01411917|Secondary|Pain Scores at 24 Hours Post-block|0-10 Pain Scale Numerical Rating Pain Scale. 0 represents no pain and 10 represents the worst pain imaginable.|24 hours post-block||||units on a scale||Standard Deviation|Mean
2679402|NCT01411917|Secondary|Pain Scores at Post-anesthesia Care Unit (PACU) Discharge|0-10 Pain Scale Numerical Rating Pain Scale. 0 represents no pain and 10 represents the worst pain imaginable.|Surgical PACU (Approximately 2 hours post-anesthesia)||||units on a scale||Standard Deviation|Mean
2679403|NCT01411917|Primary|24 Hour Postoperative Opioid Consumption|We aim to evaluate whether patients consume less opioids, over the first 24 hours post-operatively following ileostomy takedown, with the addition of a pre-operative Transversus Abdominis Plane (TAP) block for analgesia.|24 hours||||mg||Standard Deviation|Mean
2679404|NCT01411891|Secondary|Catheter Insertion Site Colonization.|Skin at the FNC insertion site will be swabbed with a sterile cotton tip applicator moistened with sterile normal saline. The swab will be placed in a sterile container. The swab will be inoculated onto a blood agar plate/eosin-methylene blue plate/chocolate agar plate and incubated for 3 days aerobically, then inoculated onto an anaerobic brucella-agar plate and incubated for 7 days anaerobically. Bacterial growth found in the first quadrant of the inoculated plate will be defined as low grade, in the second and/or third will be moderate, and in the fourth quadrant will be heavy.|24-48 hours.||||participants|||Number
2679405|NCT01411891|Primary|Catheter Tip Colonization|Three cm of the for research purposes only, a 3 cm distal portion will be cut using sterile scissors into a sterile container, and sent to the lab for culture in a sterile container. The catheter segments will be rolled onto blood agar plates at 35°C under aerobic and anaerobic conditions. Number of colonies will be counted at 1 week. The peripheral nerve catheter tip will be considered colonized if the culture yields 15 or greater colony forming units.|24-48 hours after placement of femoral nerve catheter.|Patients presenting for elective TKA.|||participants|||Number
2679406|NCT01411852|Secondary|In-hospital Mortality|Number of patients who died prior to discharge.|From day of the 911 call through hospital discharge|All enrolled patients|||participants|||Number
2679407|NCT01411852|Secondary|Penetrating Trauma 24 Hour Mortality|The 24 hour mortality endpoint for the total number of patients injured by penetrating mechanisms in each arm.|From time of hospital arrival through first 24 hours|Patients with traumatic shock due to penetrating traumatic mechanisms|||participants|||Number
2679408|NCT01411852|Secondary|Blunt Trauma 24 Hour Mortality|The 24 hour mortality endpoint for the total number of patients injured by blunt mechanisms in each arm.|From time of hospital arrival through first 24 hours|Analyzed patients had traumatic shock due to blunt traumatic mechanisms. One patient randomized to the controlled resuscitation group was not analyzed because neither blunt force nor penetrating injury had occurred. It was determined that the source of bleeding was from a gastrointestinal lesion.|||participants|||Number
2679409|NCT01411852|Secondary|Days Alive Out of the Hospital Through Day 28|"The number of days beginning with the day of the 911 call counted as Day 0 through Day 28 during which the patient is alive and not being cared for in the hospital"|From day of the 911 call through Day 28|Patients with known discharge status|||Days alive out of hospital thru day 28||Standard Deviation|Mean
2679410|NCT01411852|Secondary|Days Alive Out of the Intensive Care Unit (ICU) Through Day 28|"The number of days beginning with the day of the 911 call counted as Day 0 through Day 28 during which the patient is alive and not being cared for in the intensive care unit"|From day of the 911 call through Day 28|Patients with known discharge status|||ICU-free days||Standard Deviation|Mean
2679411|NCT01411852|Secondary|Ventilator Free Days Through Day 28|"The number of days beginning with the day of the 911 call counted as Day 0 through Day 28 during which the patient did not require mechanical ventilation. Deaths are assigned the worst score (0)."|From day of the 911 call through Day 28|Patients with known discharge status.|||Ventilator-free days||Standard Deviation|Mean
2679413|NCT01411852|Secondary|"Acute Renal Failure Classification Score of Injury Without Glomerular Filtration Rate (GFR)"|"Increased plasma creatinine > 2 x reference measure (ED admission) or urine output < 0.5 mL/kg/h x 24h. The RIFLE urine criterion for this level actually specifies a 12 hour period of assessment but study data are collected for 24-hr periods. This row includes patients who met the Failure criteria as well. Only measured for patients with at least 2 days of ICU stay assessed."|From ED arrival through Day 28|Patients with at least at 2 day stay in the ICU|||participants|||Number
2679414|NCT01411852|Secondary|"Acute Renal Failure Classification Score of Risk Without Glomerular Filtration Rate (GFR)"|"Increased plasma creatinine > 1.5 x reference measure (ED admission). Urine criteria is based on 6-hour periods for this level of the RIFLE and cannot be assessed since study data are collected for 24-hour periods. This row includes patients who met the Injury and Failure criteria as well. Only measured for patients with at least 2 days of ICU stay assessed."|From ED arrival through Day 28|Patients with at least a 2 day ICU stay|||participants|||Number
2679415|NCT01411852|Secondary|Hemorrhage Control Procedure Within 2 Hours of ED Arrival|Hemorrhage control procedures include blood vessel ligated or embolized, organ packed or removed, laparotomy or thoracotomy|From ED arrival through the first 2 hours|All patients except for 1 patient who was enrolled while in police custody|||participants|||Number
2679416|NCT01411852|Secondary|International Normalized Ratio (INR) on Admission to the Emergency Department|The first International normalized ratio (INR) value reported from blood drawn within the first 24 hours from arrival|From final Emergency Department arrival time through first 24 hours|Patients who had a first INR value measured within the first 24 hours of ED arrival|||ratio||Standard Deviation|Mean
2679417|NCT01411852|Secondary|Platelet Value on Admission|First platelet value from blood drawn in the the first 24 hours after arrival|From final Emergency Department arrival time through first 24 hours|All patients with the first platelet value measured within the first 24 hours of ED arrival|||10^9 Platelets/Liters||Standard Deviation|Mean
2679418|NCT01411852|Secondary|Hemoglobin on Admission to the Emergency Department|The first hemoglobin value reported from blood drawn in the final Emergency Department|From final Emergency Department arrival time through first 24 hours|All patients with a first hemoglobin measured within the first 24 hours of ED arrival|||grams/deciliter||Standard Deviation|Mean
2679419|NCT01411852|Secondary|Base Deficit on Admission to the Emergency Department (ED)|The first base deficit value reported from arterial blood lab work drawn after arrival in the final Emergency Department. This measure reflects the acid-base balance in the arterial blood. A negative number indicates that the blood is more acid that normal.|From final Emergency Department arrival time through first 24 hours|Patient with the first base deficit recorded in the first 24 hours of the ED arrival|||mmol/Liter||Standard Deviation|Mean
2679420|NCT01411852|Secondary|Total Blood Product Requirements in First 24 Hours|Total amount of blood products required: packed red blood cells (PRBC), fresh frozen plasma (FFP), platelets (plts), cryoprecipitate (cryo)|From ED arrival through the first 24 hours|All patients except one who was enrolled while in police custody|||Liters||Standard Deviation|Mean
2679421|NCT01411852|Secondary|Total Fluid Requirement During First 24 Hours|Total volume of fluid administered during the first 24 hours inclusive of crystalloids, blood products, 3% saline, mannitol, and other colloids|From ED arrival through the first 24 hours|All patients except one who was enrolled while in police custody|||Liters||Standard Deviation|Mean
2679422|NCT01411852|Secondary|Number of Ineligible Patients Enrolled at the Time of Randomization|"Eligibility criteria:~Inclusion Criteria~Included will be those with:~Blunt or penetrating injury~Age ≥15yrs or weight ≥50kg if age is unknown~Prehospital SBP ≤ 90 mmHg 5.3 Exclusion Criteria~Excluded will be those with:~Ground level falls~Evidence of severe blunt or penetrating head injury with a Glasgow Coma Score (GCS) ≤ 8~Bilateral paralysis secondary to suspected spinal cord injury~Fluid greater than 250 ml was given prior to randomization~Cardiopulmonary resuscitation (CPR) by Emergency Medical Services (EMS) prior to randomization~Known prisoners~Known or suspected pregnancy~Drowning or asphyxia due to hanging~Burns Total Body Surface Area (TBSA) > 20%~Time of call received at dispatch to study intervention > 4 hours"|From the time the paramedic with study drug kit arrived at patient's side to the time kit was opened prior to ED arrival|All patients enrolled in the study.|||participants|||Number
2679423|NCT01411852|Primary|24 Hour Mortality|The 24 hour mortality endpoint for the total number of patients each arm|From time of hospital arrival through the first 24 hours|All patients except for one who was enrolled while in police custody|||participants|||Number
2679424|NCT01411852|Primary|Total Volume of All Crystalloid Given for Early Resuscitation (Feasibility)|The primary feasibility endpoint was early crystalloid volume (ECV) defined as crystalloid infused from Emergency Medical Services (EMS) arrival at the scene until the end of the study period|From time of first intravenous or intraosseous insertion through the first 2 hours after hospital arrival or hemorrhage control, which ever occurs first|Patients with traumatic shock due to blunt or penetrating mechanisms|||liters||95% Confidence Interval|Mean
2679425|NCT01411839|Secondary|MedSignals Electronic Pill-box for Adherence|The MedSignals electronic pill-box is a storage bin that allows participants to store medications. In the treatment condition, the pill-box provides audio commands to alarm participants that it is time to take their medication. The pill-box stores adherence data (time, number of openings). In the control condition, the pill-box does not alarm participants but serves in the same capacity otherwise. All data is uploaded electronically. Higher numbers indicate better adherence that correspond to pill-box openings corresponding to the designated time of taking their medication.|6 and 9 month follow-up adherence scores||||Percent adherence||Standard Deviation|Mean
2679426|NCT01411839|Secondary|Self-Report Adherence|Self-reported adherence was assessed with the visual analog scale (VAS). The VAS is a 10cm line that is shown to patients who then mark on the line (from 0 to 100% in 1cm intervals) how much medication they have taken. Higher scores indicate better adherence.|Self-reported adherence at 6 and 9-month follow-up||||Percent of all doses of medication taken||Standard Deviation|Mean
2679443|NCT01411488|Primary|Number of Patients With Anal Erosion Within 14 Days After Insertion of FMS|anal erosion within 14 days after insertion of FMS|up to 14 days|Pearson's chi square test (categorical data) and Wilcoxon test (continuous measures). Logistic regression was used to assess primary endpoint by time the device was in use.|||Participants|||Count of Participants
2680327|NCT01402102|Secondary|Changes in Total Cholesterol|Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||mg/dL||Standard Deviation|Mean
2679427|NCT01411839|Primary|Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a|"Clinician-administered ratings are scored on the MADRS. The MADRS is a 10-item, past 7-day clinician administered scripted rating scale of depressive symptoms (each of the ten items is scored from 0-6, with total scores ranging from 0 to 60). The areas are: apparent and reported sadness, inner tension, reduced sleep/appetite, concentration difficulties, lassitude, inability to feel, pessimistic and suicidal thoughts. Higher scores indicate the presence of more depressive symptoms.~Participant self-report ratings are scored on the BDI-1a. The BDI-1a is assessed at each time point using the revised Beck Depression Inventory-Ia (BDI-Ia), which consists of 21 items, each with a 4-point response scale anchored with descriptive statements. Scores can range from 0-63, and scores of 10 or higher are presumptive of mild depressive severity. The BDI scores presented were added up and higher scores indicate worse depression. The MADRS and BDI-Ia is scored a total units on the scale."|MADRS and BDI-1a scores at 6 and 9-month follow-up||||Units on a scale||Standard Deviation|Mean
2679428|NCT01411774|Secondary|Clinical Global Impression-Severity|The Clinical Global Impression-Severity involves a trained clinician rating how severe the person's OCD symptoms are on a 0 to 6 scale, with higher scores corresponding to more severe symptoms. This rating only involves a clinician completing a single item.|10 weeks||||units on a scale||95% Confidence Interval|Mean
2679429|NCT01411774|Primary|Children's Yale-Brown Obsessive-Compulsive Scale.|The Children's Yale-Brown Obsessive-Compulsive Scale measures the severity of OCD symptoms. There are 10 questions that are summed to arrive at a total score, with higher scores representing more severe OCD symptoms (scores range from 0-40).|10 weeks||||units on a scale||95% Confidence Interval|Mean
2679430|NCT01411696|Secondary|Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection|Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and 4 to 20 weeks after each injection. A negative change from baseline indicates improvement.|Baseline, 4 to 20 Weeks after Each injection (up to 6 months)|All participants with data available for analysis.|||Micron (μm)||Standard Deviation|Mean
2679431|NCT01411696|Secondary|Percentage of Participants With an Increase of 3 Lines or More in BCVA|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement.|Baseline, Up to 6 months|All participants.|||Percentage of participants|||Number
2679432|NCT01411696|Secondary|Percentage of Participants With an Increase of 2 Lines or More in BCVA|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement.|Baseline, Up to 6 months|All participants.|||Percentage of participants|||Number
2679433|NCT01411696|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection|BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The change in BCVA was calculated using the most improved number of lines read correctly between 4 and 20 weeks following the last injection of OZURDEX® - the number of lines read correctly at baseline. A positive change from baseline indicates improvement.|Baseline, 4 to 20 weeks after last injection (Up to 6 months)|All participants with data available for analysis.|||Lines||Full Range|Mean
2679434|NCT01411592|Secondary|Debonding of the RBFDP|Restoration was rebonded without any impairment of function|5 years||||participants|||Number
2679435|NCT01411592|Primary|Final Loss of the Restauration||5 years||||participants|||Number
2679436|NCT01411527|Primary|Pubertal Onset|"Pubertal onset (according to Tanner stageing - Marshall & Tanner 1969 and 1970), i.e. Tanner stages B2+ or G2+ [Tanner stages included genital stages 1-5 as well as pubic hairs tages 1-6]~Data of both arms were pooled for calculation of means."|up to 8 year period.|Population|||years||95% Confidence Interval|Mean
2679437|NCT01411501|Secondary|Change From Baseline in Difficulty Degree of Defecation at the 8th Week|"This outcome describes how much effort the patients with while defecating. It ranges from 0 to 3.~0—Without difficulty~Defecation straining~Severe defecation straining~Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings.~[the average score of one week at the 8th week]-[the average score of one week at baseline]"|baseline and at 8 weeks||||participants|||Number
2679438|NCT01411501|Secondary|Change From Baseline in the Bristol Stool Scale at the 8th Week|Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 8th week-the Bristol Stool Scale at baseline.|baseline and at 8 weeks||||units on a scale||Full Range|Mean
2679439|NCT01411501|Secondary|Changes of the SBMs From Baseline at Week 8|[average number of spontaneous bowel movements in a week at week 8]-[average number of spontaneous bowel movements in a week at baseline]|baseline and at 8 weeks||||times per week||95% Confidence Interval|Mean
2679440|NCT01411501|Secondary|Change From Baseline in Difficulty Degree of Defecation at the 4th Week|"This outcome describes how much effort the patients with while defecating.It ranges from 0 to 3.~0—Without difficulty~Defecation straining~Severe defecation straining~Defecation with the help of hands, A 0 is considered better than 3 for outcome. Patients score for themselves according to their own feelings.~[the average score of one week at the 4th week]-[the average score of one week at baseline]"|baseline and at 4 weeks||||participants|||Number
2679441|NCT01411501|Secondary|Change From Baseline in the Bristol Stool Scale at the 4th Week|Bristol stool scale provides illustration of seven stool types. It ranges from 1 to 7 with the meaning that 1 referring to separate hard lumps and 7 referring to watery, no solid pieces. For patients with constipation, a higher score means a better outcome. This outcome means the Bristol Stool Scale at the 4th week-the Bristol Stool Scale at baseline.|baseline and at 4 weeks||||units on a scale||95% Confidence Interval|Mean
2679442|NCT01411501|Primary|Change of the SBMs From Baseline at Week 4|[average number of spontaneous bowel movements in a week at week 4]-[average number of spontaneous bowel movements in a week at baseline]|baseline and at 4 weeks||||times per week||95% Confidence Interval|Mean
2679445|NCT01411267|Secondary|Disease Response|Possible outcomes are: Complete Remission (CR), Complete Remission without Platelet Recovery (CRp), complete response with incomplete hematologic recovery (CRi), Stable Disease, Progressive Disease, Induction Death, or Relapse|10 weeks|Five of 22 patients were not evaluable for response per protocol because they were removed from protocol therapy prior to disease assessment without meeting PD criteria|||Participants|||Count of Participants
2679446|NCT01411267|Primary|The Dose of AC220 That is Safe and Biologically Active When Given in Sequential Combination With Ara-C/Etoposide|The incidence of dose limiting toxicity (DLT) will be measured. The maximum tolerated dose will be the highest study dose at which 1 or fewer of six patients experience DLT during cycle 1 of therapy. Plasma inhibitor activity (PIA) will be measured Pre-treatment and on Days 7, 14, 21 and 28 of Course 1. For the MTD to be considered biologically active, we will require that 7 of 9 patients achieve PIA of > 90% at 3 of 4 trough time points.|4 weeks from therapy start|No patients with ALL were enrolled during Dose Level 1.|||Participants|||Count of Participants
2679447|NCT01411241|Secondary|Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Third Injection of CYD Dengue Vaccine|Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: >=50 mm. Grade 3 Solicited systemic reactions: Fever: >39.5°C; Vomiting: >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: >3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses >=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable.|Day 0 up to Day 14 post-third injection|Analysis was performed on Safety analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2679448|NCT01411241|Secondary|Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Second Injection of CYD Dengue Vaccine or a Placebo Vaccine|Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: >=50 mm. Grade 3 Solicited systemic reactions: Fever: >39.5°C; Vomiting: >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: >3 hours; Drowsiness, Sleeping most of the time or difficult to wake up; Appetite lost: refuses >=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable.|Day 0 up to Day 14 post-second injection|Analysis was performed on Safety analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2679449|NCT01411241|Secondary|Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered Concomitantly With Either CYD Dengue Vaccine or a Placebo Vaccine|Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reactions: Tenderness: cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: >=50 mm. Grade 3 Solicited systemic reactions: Fever: >39.5°C; Vomiting: >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: >3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses >=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable; and Extensive swelling, severe.|Day 0 up to Day 14 post-booster injection|Analysis was performed on Safety analysis set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure and ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2679450|NCT01411241|Secondary|Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following the First Injection With CYD Dengue Vaccine|Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade (Grd) 3 Solicited injection site reactions: Tenderness, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling: >=50 mm. Grade 3 Solicited systemic reactions: Fever: >39.5 degree Celsius (°C); Vomiting: >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal: >3 hours; Drowsiness: Sleeping most of the time or difficult to wake up; Appetite lost: refuses >=3 feeds/meals or refuses most feeds/meals; Irritability: inconsolable.|Day 0 up to Day 14 post-first injection|Analysis was performed on Safety analysis set which included participants who received at least one dose of CYD dengue vaccine, Pentaxim vaccine or placebo. Here, ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2679451|NCT01411241|Secondary|Percentage of Participants With Seropositivity Against at Least One, Two, Three, or Four Serotypes With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV// Hib (Pentaxim™) Administered With CYD Dengue Vaccine|Seropositivity against each dengue virus serotype (parental strains) were measured by dengue PRNT. Seropositivity was defined as antibody titers >=10 (1/dilution).|Pre-injection 1 and 28 days post-injection 2 and 3|Analysis was performed on Full analysis set for dengue immunogenicity. Here, ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2679452|NCT01411241|Secondary|Percentage of Participants With a Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine|Seropositivity against each dengue virus serotype (parental strains) were measured by dengue PRNT. Seropositivity was defined as antibody titers >=10 (1/dilution).|Pre-injection 1 and 28 days post-injection 2 and 3|Analysis was performed on Full analysis set for dengue immunogenicity. Here, ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2679515|NCT01410448|Secondary|Percentage of Participants With Proteinuria|Incidence of proteinuria (>1,000 mg/day in urine collected in 24 hours or > 1.0 if measured on the urine protein/creatinine concentration ratio in a spot urine sample) was assessed.|3 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.|||Percentage of participants|||Number
2679453|NCT01411241|Secondary|Geometric Mean Titer Ratios Against Each Serotype With the Parental of Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine|Geometric mean titers of antibodies against the dengue virus serotypes were measured by dengue PRNT.|Pre-injection 1 and 28 days post-injection 2 and 3|Analysis was performed on Full analysis set for dengue immunogenicity. Here, ‘number analyzed’ = participants with available data for each specified category.|||Titer ratio||95% Confidence Interval|Geometric Mean
2679454|NCT01411241|Secondary|Geometric Mean Titers Against Each Serotype With the Parental Dengue Virus Strains Before and After a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine|Geometric mean titers of antibodies against the dengue virus serotypes were measured by dengue plaque reduction neutralization test (PRNT).|Pre-injection 1 and 28 days post-injection 2 and 3|Analysis was performed on Full analysis set for dengue immunogenicity which included participants randomized into the dengue immunogenicity subset who received at least one dose of CYD dengue vaccine. Here, ‘number analyzed’ = participants with available data for each specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2679455|NCT01411241|Primary|Percentage of Participants With Seroprotection or Booster Response After a Booster Injection (Inj.) of Diphtheria, Tetanus, Acellular Pertussis(DTaP)-Inactivated Polio Virus (IPV)//Hib (Pentaxim™) Administered Concomitantly With CYD Dengue Vaccine|Antibodies (Ab) against diphtheria, tetanus toxoid, pertussis toxoid (PT), and filamentous hemaglutinin (FHA) was measured by enzyme-linked immunosorbent assay (ELISA), polyribosylribitol phosphate (PRP) by Farr-type radioimmunoassay, and poliovirus types 1, 2, and 3 by seroneutralization assay. Seroprotection was defined as >=0.1 International Unit (IU)/mL for diphtheria toxoid and tetanus toxoid, >=8 1/dil for poliovirus types 1, 2, and 3, and >=1.0 μg/mL for PRP. Booster response to PT and FHA: participants whose pre-vaccination Ab titers were < lower limit of quantitation (LLOQ), a booster response occurred if they had post-vaccination levels >=4* LLOQ; participants whose pre-vaccination Ab concentrations were >=LLOQ but <4* LLOQ, a booster response occurred if they had a 4-fold increase (post/pre-vaccination levels >=4); for participants whose pre-vaccination Ab concentrations were >=4* LLOQ, a booster response occurred if they had a 2-fold increase (post/pre-vaccination >=2).|28 days post-injection|Per-protocol analysis set:all participants who had no protocol deviations (not meet inclusion/exclusion criteria,not received vaccine in time window, administration not done per protocol) and could impact Pentaxim vaccine immunogenicity up to Visit 06 (Month 07). Here, ‘number analyzed’=participants with available data for each specified category.|||Percentage of participants|||Number
2679456|NCT01411228|Secondary|Liver Volume|Liver volume by MRI or Ultrasound. Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 12 and 24|Two Switchover Patients completed 18 months treatment due to early closure of the study site and continued in a compassionate use program|||Milliliters||Standard Error|Mean
2679457|NCT01411228|Secondary|Platelet Count|Platelet count. Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 9, 12, 24 and 33-36|Two Switchover Patients completed 18 months treatment due to early closure of the study site and continued in a compassionate use program|||Platelets/mm^3||Standard Error|Mean
2679458|NCT01411228|Secondary|Spleen Volume|Spleen volume measured by MRI (or ultrasound). Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 12 and 24|Two Switchover Patients completed 18 months treatment due to early closure of the study site and continued in a compassionate use program|||Milliliters||Standard Error|Mean
2679459|NCT01411228|Secondary|Chitotriosidase|Chitotriosidase. Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 9, 12 and 24|Chitotriosidase was not analyzed for the subjects in the Switchover group|||nmol/mL*h||Standard Deviation|Mean
2679460|NCT01411228|Primary|Hemoglobin|Median and interquartile range. Baseline is the value obtained from the parent study: PB-06-005 for 30 and 60 Units/kg arms and PB-06-002 from Switchover arm.|Baseline, months 9, 12 and 24|Two Switchover Patients completed 18 months treatment due to early closure of the study site and continued in a compassionate use program|||g/dL||Inter-Quartile Range|Median
2679461|NCT01411215|Secondary|Number of RA Participants Had Remission of Disease|Counts of participants had remission of disease. Remission of disease was defined by a DAS28-4 (ESR) <2.6.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for DAS28-4 (ESR). n=number of evaluable participants at the corresponding visit.|||Participants|||Number
2679462|NCT01411215|Secondary|Number of RA Participants Had DAS28-4 (ESR) Improvement|Counts of participants had good, moderate and no response to treatment with etanercept. Good response was present DAS28-4 (ESR) <=3.2, DAS28-4 (ESR) improvement from baseline >1.2. Moderate response was 1) present DAS28-4 (ESR) >3.2 and <=5.1, DAS28-4 (ESR) improvement from baseline >1.2, or >0.6 and <=1.2; 2) present DAS28-4 (ESR) <=3.2, DAS28-4 (ESR) improvement from baseline >0.6 and <=1.2; or 3) present DAS28-4 (ESR) >5.1, DAS28-4 (ESR) improvement from baseline > 1.2. No response was 1) DAS28-4 (ESR) improvement from baseline <=0.6 regardless present DAS28-4 (ESR), or 2) present DAS28-4 (ESR) >5.1, DAS28-4 (ESR) improvement from baseline >0.6 and <=1.2.|Week 2, Week 4, Week 8, Week 12, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for DAS28-4 (ESR) improvement. n=number of evaluable participants at the corresponding visit.|||Participants|||Number
2679463|NCT01411215|Secondary|Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])|DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity on a 0-100 mm VAS: DAS28-4 (ESR)=0.56*square root(TJC 28 joints) + 0.28*square root(SJC 28 joints) + 0.70*ln(ESR) + 0.014*PtGA. DAS28-4 (ESR) above 5.1 indicated high disease activity whereas a DAS28-4 (ESR) below 3.2 indicated low disease activity.|Baseline (Week 0), Week 2, Week 4, Week 12, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were RA participants who were evaluated for DAS28-4 (ESR). n=number of evaluable participants at the corresponding visit.|||units on a scale||Standard Deviation|Mean
2679554|NCT01410357|Primary|Body Mass Index (BMI) at 60 Weeks||60 weeks||||kg/m^2||Standard Deviation|Mean
2679555|NCT01410357|Primary|Systolic Blood Pressure at 60 Weeks||60 weeks||||mmHg||Standard Deviation|Mean
2679464|NCT01411215|Secondary|Swollen Joint Count (SJC) for RA Participants|SJC (28 joints) include the joints of shoulders, elbows, wrists, MCP, PIP, and the knees. The joints were assessed for swelling using the following scale: Present (1), Absent (2), Not Done (3), Not Applicable (4). Artificial joints were not assessed.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were RA participants who were evaluated for SJC. n=number of evaluable participants at the corresponding visit.|||Joints||Standard Deviation|Mean
2679465|NCT01411215|Secondary|Tender Joint Count (TJC) for RA Participants|TJC (28 joints) include the joints of shoulders, elbows, wrists, metacarpophalangeal (MCP), proximal interphalangeal (PIP), and the knees. The joints were assessed for tenderness using the following scale: Present (1), Absent (2), Not Done (3), Not Applicable (4). Artificial joints were not assessed.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were RA participants who were evaluated for TJC. n=number of evaluable participants at the corresponding visit.|||Joints||Standard Deviation|Mean
2679466|NCT01411215|Secondary|Number of Participants With Any Abnormal Laboratory Test Results|Number of participants with any abnormal laboratory test results, criteria for abnormalities were complete blood count (CBC) including hemoglobin (<0.8*lower limit of normal[LLN]), mean corpuscular volume (MCV, <0.9*LLN or >1.1*upper limit of normal[ULN]), hematocrit (<0.8*LLN), red blood cell count (<0.8*LLN), platelets (<0.5*LLN or >1.75*ULN), white blood cell count (<0.6*LLN or >1.5*ULN), lymphocytes (<0.8*LLN or >1.2*ULN), neutrophils (<0.8*LLN or >1.2*ULN), basophil (>1.2*ULN), eosinophil (>1.2*ULN), and monocytes (>1.2*ULN); ESR (>1.5*ULN); aspartate aminotransferase (AST,>3.0*ULN); alanine aminotransferase (ALT,>3.0*ULN); blood urea nitrogen (BUN,>1.3*ULN); and creatinine (CRE,>1.3*ULN).|Baseline (Week 0) up to Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for laboratory test abnormalities.|||Participants|||Number
2679467|NCT01411215|Secondary|Evaluate the Association Between Participant's Age and Treatment Adherence Rate|Participants were allocated to 5 groups by age as 10 years separately: <20 years, >=20 and <30 years, >=30 and <40 years, >=40 and <50 years, >50 years. The number of participants with treatment adherence rate 1), <50%, 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120% were provided for each age group described above.|First day of receiving etanercept up to Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for treatment adherence rate; those participants with partial dosing dates were excluded. n=number of evaluable participants at the corresponding age group.|||Participants|||Number
2679468|NCT01411215|Secondary|Number of Participants With Treatment Adherence Rate of 1), <50 Percents (%), 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120%|Treatment adherence rate was calculated using the following formula: [Actual dosing/expected dosing on the basis of approved product label] × 100%. Counts of participants by 6 levels of treatment adherence rate: 1), <50%, 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120%.|First day of receiving etanercept up to Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for treatment adherence rate; those participants with partial dosing dates were excluded.|||Participants|||Number
2679469|NCT01411215|Secondary|VAS Score for Pain|Participants placed a mark on a 0-100 mm VAS to indicate the magnitude of pain, with 0 meaning no pain and 100 meaning the most severe pain.|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for pain. n=number of evaluable participants at the corresponding visit.|||mm||Standard Deviation|Mean
2679470|NCT01411215|Secondary|Participant's Global Assessment (PtGA) of Disease Activity|Participants placed a vertical line on a 0-100 mm VAS to indicate the magnitude of their global disease activity, with 0 meaning no disease activity (disease inactive) and 100 meaning extreme disease activity (disease extremely active).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for PtGA of disease activity. n=number of evaluable participants at the corresponding visit.|||mm||Standard Deviation|Mean
2679471|NCT01411215|Secondary|Physician's Global Assessment of Disease Activity|Physicians indicated on a 0-100 millimeters (mm) visual analogue scale (VAS) to assess the activity of the participant's disease according to the participant's clinical condition, with 0 meaning no disease activity (disease inactive) and 100 meaning extreme disease activity (disease extremely active).|Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52|All enrolled participants who received at least 1 dose of etanercept. Participants analyzed were participants who were evaluated for physician’s global assessment of disease activity. n=number of evaluable participants at the corresponding visit.|||mm||Standard Deviation|Mean
2679472|NCT01411215|Primary|Number of Participants With AEs Per System Organ Class During 52 Weeks|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category.|First day of receiving etanercept through 52 weeks|All enrolled participants who received at least 1 dose of etanercept.|||Participants|||Number
2679473|NCT01411215|Primary|Number of Participants With AEs Per System Organ Class During 24 Weeks|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category.|First day of receiving etanercept through 24 weeks|All enrolled participants who received at least 1 dose of etanercept.|||Participants|||Number
2679474|NCT01411215|Primary|Number of Participants Who Had Any SAEs During 52 Weeks|An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Informed consent or signed data privacy statement through 52 weeks|All enrolled participants who received at least 1 dose of etanercept.|||Participants|||Number
2679556|NCT01410357|Primary|Glycosylated Hemoglobin (HbA1c) at 60 Weeks||60 weeks||||mmol/mol||Standard Deviation|Mean
2679475|NCT01411215|Primary|Number of Participants Who Had Any Serious Adverse Events (SAEs) During 24 Weeks|An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Informed consent or signed data privacy statement through 24 weeks|All enrolled participants who received at least 1 dose of etanercept.|||Participants|||Number
2679476|NCT01411215|Primary|Number of Participants Who Had Any AEs During 52 Weeks|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|First day of receiving etanercept through 52 weeks|All enrolled participants who received at least 1 dose of etanercept.|||Participants|||Number
2679477|NCT01411215|Primary|Number of Participants Who Had Any Adverse Events (AEs) During 24 Weeks|An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.|First day of receiving etanercept through 24 weeks|All enrolled participants who received at least 1 dose of etanercept.|||Participants|||Number
2679478|NCT01411137|Primary|Parkinson's Disease Questionnaire-8 (PDQ-8)|Change from Baseline in Parkinson's disease Questionnaire-8 (PDQ-8) at End of Study or early discontinuation. The PDQ-8 is a self-reported questionnaire consisting of 8 questions regarding the subject's disease symptoms, each item ranging from 0 to 4, and the responses consist of 0=Never, 1=Occasionally, 2=Sometimes, 3=Often, and 4=Always or cannot do at all, total score ranging from 0 (never have problems/issues) to 32 (always have problems or cannot do at all).|6 months||||units on a scale||Standard Deviation|Mean
2679479|NCT01411137|Primary|Clinical Global Impression (CGI)|"Clinician-reported satisfaction outcome of IPX066 using Clinical Global Impression (PGI) 7-point scale.~At Part 1 Week 6; Part 2 Month 3, and Month 6 or at Early Termination, the Investigator rated how much a subject's overall condition had changed since Part 1 Visit 1 (Baseline) using 7-point scale. 1=very much worse and 7=very much improved."|6 months||||units on a scale||Standard Deviation|Mean
2679480|NCT01411137|Primary|Patient Global Impression (PGI)|At Part 1 Week 6, Part 2 Month 3 and Month 6 or at Early Termination, the subjects rated the change in their condition with IPX066 treatment from their condition prior to Part 1 Visit 1(Baseline) using Patient Global Impression (PGI) 7-point scale. 1=very much worse and 7=very much improved.|6 months||||units on a scale||Standard Deviation|Mean
2679481|NCT01411085|Primary|Timeline Followback Assessing Number of Drinks Per Week|Alcohol/other substance use (including tobacco) will be assessed primarily by weekly self-report using the Timeline Followback (TLFB) method enhanced by procedures to strengthen the reliability and validity of this measure. It involves asking participants to retrospectively estimate their alcohol and other substance use.|Weekly for 14 weeks, using data from last 8 weeks|The analysis was performed on all completers (N=7).|||Drinks per week||Standard Deviation|Mean
2679482|NCT01410812|Secondary|Dollar Amount Participants Would Pay for Enrollment|Willingness to pay is measured as the dollar amount a participant would pay to be enrolled in a program such as the treatment. Participant who would pay more are said to be more willing to pay, as opposed to those who would pay less or not at all.|9 weeks|Some of the participants failed to respond for this outcome measure.|||Dollars||Standard Deviation|Mean
2679483|NCT01410812|Primary|Average Weekly Gym Attendance From Baseline to Week 9||9 weeks||||Average Weekly Gym Attendance||95% Confidence Interval|Mean
2679484|NCT01410799|Secondary|Tolerability of Nocturnal Administration|Subjects record diary of drug administration in evening and morning describing any issues with pump system for drug delivery, local skin issues at site of injection or other adverse events. Study nurses also record telephone contact with subjects every other day for first week of dosing and weekly for first month.|Ongoing throughout 12 weeks|Study was terminated, no data collected.||||||
2679485|NCT01410799|Secondary|Physical Performance|6 Minute Walk Test|Baseline and 12 weeks|Study was terminated, no data collected.||||||
2679486|NCT01410799|Secondary|Fuel Utilization|Assessment of resting metabolic rate|baseline and 12 weeks|Study was terminated, no data collected.||||||
2679487|NCT01410799|Secondary|Fat-free and Lean Mass|iDXA scan|baseline and 12 weeks|Study was terminated, no data collected.||||||
2679488|NCT01410799|Secondary|Glucose Homeostasis|Glucose clamp study at week 12 of study drug use|12 weeks|Study was terminated, no data collected.||||||
2679489|NCT01410799|Primary|Muscle Strength|Pre-drug and post-drug 1 RM (Repetition Maximum) testing|12 weeks|Study was terminated, no data collected.||||||
2679490|NCT01410773|Secondary|Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test subject Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGM meter results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG results >=75mg/dL) of the YSI capillary plasma reference method results.|1 hour|One subject had low blood sugar. The protocol (and User Guide) do not allow alternative site testing when blood sugar is low. The remaining 109 subjects tested one strip lot on the BGM system. 109 test results were available.|||participants|||Number
2679491|NCT01410773|Primary|Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method|Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Meter (BGM). BGM results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or within +/- 20%(for reference BG results >=75mg/dL) of the reference method results (YSI capillary plasma).|1 hour|110 subjects tested one of 3 test strip lots on the BGM system. 110 (1x110) test results are available.|||participants|||Number
2679492|NCT01410604|Secondary|Waist Circumference|Change from baseline in Waist circumference after 3 months of treatment.|baseline and 3 months||||cm||Standard Deviation|Mean
2679493|NCT01410604|Secondary|Body Mass Index|Change from baseline in Body Mass Index after 3 months of treatment.|baseline and 3 months||||kg/m^2||Standard Deviation|Mean
2679494|NCT01410604|Secondary|Fasting Insulin|Change from baseline in Fasting insulin after 3 months of treatment.|baseline and 3 months||||µU/mL||Standard Deviation|Mean
2679500|NCT01410565|Secondary|Participants With Treatment Emergent Adverse Events (TEAEs)|TEAEs will be mainly characterized by the number of treatment emergent adverse events and treatment related AEs that occur or worsen after the first dose of study treatment.|24 Months from Randomization|All patients who received Apaziquone in the Open Label Phase and subsequently randomized to one of the treatment arms in the Double Blind Phase.|||participants|||Number
2679501|NCT01410565|Secondary|Recurrence Rate at 24 Months|Measurement the number of participants with the recurrence at 24 months.|24 months|All patients who received Apaziquone in the Open Label Phase and subsequently randomized to one of the treatment arms in the Double Blind Phase.|||participants|||Number
2679502|NCT01410565|Primary|Time to Recurrence|Time to recurrence is the time from randomization to the date of first histologically confirmed recurrence of bladder cancer (for eligible patients with Low- intermediate risk NMIBC, who had undergone TURBT followed by, a single instillation of apaziquone immediately post TURBT and multiple instillations of apaziquone or placebo).|Recurrence of cancer in the bladder during 24 months of follow-up|All patients who received Apaziquone in the Open Label Phase and subsequently randomized to one of the treatment arms in the Double Blind Phase. Participants without recurrence were censored.|||months||Full Range|Mean
2679503|NCT01410552|Secondary|Shock(s) Appropriately Delivered|Percentage of shocks appropriately delivered|552 days||||Percentage of appropriate shocks|||Number
2679504|NCT01410552|Primary|Patients With Inappropriate Shock(s)|Percentage of patients presenting with inappropriate shock(s)|552 days||||Percentage of pts with inap shocks|||Number
2679505|NCT01410474|Secondary|Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years|Safety was assessed as the number of subjects aged 6 to 18 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination.|From day 1 through day 7 postvaccination|Analysis was done on safety population.|||Subjects|||Number
2679506|NCT01410474|Secondary|Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years|Safety was assessed as the number of subjects aged 2 to 5 years who reported solicited local and systemic adverse events (AEs) within days 1 through 7 after MenACWY-CRM vaccination.|From day 1 through day 7 postvaccination|Analysis was done on safety population i.e. the subjects in the exposed population who provided post-baseline safety data.|||Subjects|||Number
2679507|NCT01410474|Secondary|Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination|Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, before vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), bye age group and overall.|Day 1 and 29|Analysis was done on MITT population|||Percentages of Subjects||95% Confidence Interval|Number
2679508|NCT01410474|Secondary|Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination|Immunogenicity was measured as ratio of postvaccination GMTs to prevaccination GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, at 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.|Day 1 and Day 29|Analysis was done on MITT population|||Ratio||95% Confidence Interval|Geometric Mean
2679509|NCT01410474|Secondary|Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination|Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, before the vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.|Day 1 and 29|Analysis was done on MITT population|||hSBA Titers||95% Confidence Interval|Geometric Mean
2679510|NCT01410474|Secondary|Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group|"Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% CI, directed against N. meningitidis serogroups A, C, W and Y, at Day 29, by age groups.~Seroresponse is defined as:~for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8.~for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer."|Day 1 and Day 29|Analysis was done on MITT population|||Percentages of Subjects||95% Confidence Interval|Number
2679511|NCT01410474|Primary|Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination|"Immunogenicity was measured as the percentage of subjects with hSBA seroresponse and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at 28 days after one vaccination of MenACWY-CRM (day 29).~Seroresponse is defined as:~for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8.~for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer."|Day 1 and Day 29|Analysis was done on modified intention-to-treat (MITT) population i.e subjects in the exposed population who provided evaluable serum samples whose assay results were available for at least one serogroup on day 1 and/or day 29.|||Percentages of Subjects||95% Confidence Interval|Number
2679512|NCT01410448|Secondary|Percentage of Participants With a New Onset of Diabetes|The percentage of participants with a new onset of diabetes was assessed.|12 months|Participants from the modified ITT, who had values at 12 months, were analyzed. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant.|||Percentage of participants|||Number
2679513|NCT01410448|Secondary|Percentage of Participants With a New Onset of Malignancy|The percentage of participants with a new onset of malignancy was assessed.|12 months|Participants from the modified ITT, who had values at 12 months, were analyzed. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant.|||Percentage of participants|||Number
2679514|NCT01410448|Secondary|Percentage of Participants With Acute Rejection (AR)|AR was defined as an episode of increased serum creatinine >30% that was clinically diagnosed as an acute rejection but was not biopsy proven.|12 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.|||Percentage of participants|||Number
2680328|NCT01402102|Secondary|Changes in Triglycerides|Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|PP analysis|||mg/dl||Standard Deviation|Mean
2679516|NCT01410448|Secondary|Change From Baseline in Serum Creatinine - Modified ITT|Blood samples were collected to assess serum creatinine measurements. A negative change from baseline indicates improvement.|baseline, 12 months|Participants from the modified ITT, who had both baseline and month 12 measurements, were included in the analysis for the month 12 time point. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant.|||mg/dL||Standard Deviation|Mean
2679517|NCT01410448|Secondary|Change From Baseline in Serum Creatinine - ITT|Blood samples were collected to assess serum creatinine measurements. A negative change from baseline indicates improvement.|baseline, 3 months|Participants from the ITT, who had both baseline and the post-baseline measurement for a given post-baseline time point, were included in the analysis for that post-baseline time point. The ITT population included all randomized participants who were treated.|||mg/dL||Standard Deviation|Mean
2679518|NCT01410448|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - Modified ITT|Renal function was assessed by measuring serum creatinine and serum urea and by calculating creatinine clearance using the MDRD-4 formula. eGFR = 186.3*(serum creatinine [mg/dL])^-1.154 * (age at screening) -0.203 * (0.742 if female) * (1.21 if African American). A positive change from baseline indicates improvement.|baseline, 12 months|Participants from the modified ITT, who had both baseline and month 12 measurements, were included in the analysis for the month 12 time point. The modified ITT included participants who completed the Core Phase (at 3 months) without discontinuing the treatment and performed the subsequent follow-up evaluation at 12 months after transplant.|||mL/min||Standard Deviation|Mean
2679519|NCT01410448|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - ITT|Renal function was assessed by measuring serum creatinine and serum urea and by calculating creatinine clearance using the MDRD-4 formula. eGFR = 186.3*(serum creatinine [mg/dL])^-1.154 * (age at screening) -0.203 * (0.742 if female) * (1.21 if African American). A positive change from baseline indicates improvement.|baseline, 3 Months|Participants from the ITT, who had both baseline and month 3 measurements, were included in the analysis for the month 3 time point. The ITT population included all randomized participants who were treated.|||mL/min||Standard Deviation|Mean
2679520|NCT01410448|Secondary|Duration of DGF|The duration of DGF was defined as the elapsed time from first to last day of post-transplant dialysis.|3 months|Participants from the Intent-to-Treat (ITT) populations who required dialysis, 46 (23.83%) of the IE group and 60 (31.58%) of the DE group, were analyzed. The ITT population included all randomized participants who were treated.|||Days||Full Range|Median
2679521|NCT01410448|Secondary|Percentage of Participants With Delayed Graft Function (DGF) -|DGF was defined as the need for dialysis in the first week after transplant, excluding Renal Replacement Therapy within the first 24 hours after transplantation.|3 Months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.|||Percentage of participants|||Number
2679522|NCT01410448|Secondary|Percentage of Participants With BPAR - Worst-case Scenario|A biopsy-proven acute rejection was defined as a biopsy graded IA, IB, IIA, IIB or III. In the worst-case scenario, failure, i.e. BPAR, was identified in one of the following cases: occurrence of BPAR or study discontinuation due to any reason.|3 Months, 12 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.|||Percentage of participants|||Number
2679523|NCT01410448|Secondary|Graft Survival Rate: Percentage of Participants With Graft Loss - Worst-case Scenario|The percentage of participants who experienced graft loss was assessed. In the worst-case scenario, failure, i.e. graft loss, was identified in one of the following cases: occurrence of graft loss or discontinuation due to any reason.|3 months, 12 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.|||Percentage of participants|||Number
2679524|NCT01410448|Secondary|Participant/Graft Survival Rate: Percentage of Participants With Failure Events of Death or Graft Loss - Worst-case Scenario|The percentage of participants who experienced death or graft loss was assessed. In the worst-case scenario, failure, i.e. participants death or graft loss, was identified in one of the following cases: occurrence of at least one failure event or study discontinuation due to any reason.|3 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.|||Percentage of participants|||Number
2679525|NCT01410448|Secondary|Patient Survival Rate: Percentage of Deaths - Worst-case Scenario|The percentage of deaths was assessed. In the worst-case scenario, failure, i.e. death, was identified in one of the following cases: participant's death or study discontinuation due to any reason.|3 Months, 12 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.|||Percentage of participants|||Number
2679526|NCT01410448|Secondary|Percentage of Participants Who Experienced Treatment Failure - Worst-case Scenario|The percentage of participants who experienced treatment failure was assessed. Treatment failure was defined as the occurrence of at least one failure event among death, graft loss or biopsy-proven acute rejection (BPAR). In the worst-case scenario, treatment failure was identified in one of the following cases: occurrence of at least one treatment failure event or study discontinuation due to any reason.|3 months|The intent to treat (ITT) population, which included all randomized participants who were treated, was analyzed.|||Percentage of participants|||Number
2679527|NCT01410448|Secondary|Percentage of Participants Without Wound Healing Complications - Worst-case Scenario|The percentage of participants without wound healing complications was assessed. Wound healing complications consisted of lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia. In the worst-case scenario, failure, i.e. at least one healing complication occurrence, was identified in one of the following cases: wound complication occurrence, missing information about wound complication occurrence or study discontinuation due to any reason for participants who did not complete the 12 month follow-up visit.|12 months|The safety population, which included all randomized participants who were treated and had at least one safety assessment, was analyzed.|||Percentage of participants|||Number
2679576|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Wheelchair|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set|||participants|||Number
2679528|NCT01410448|Primary|Percentage of Participants Without Wound Healing Complications - Worst-case Scenario|The percentage of participants without wound healing complications was assessed. Wound healing complications consisted of lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia. In the worst-case scenario, failure, i.e. at least one healing complication occurrence, was identified in one of the following cases: wound complication occurrence, missing information about wound complication occurrence, or study discontinuation due to any reason.|3 months|The safety population, which included all randomized participants who were treated and had at least one safety assessment, was analyzed.|||Percentage of participants|||Number
2679529|NCT01410409|Other Pre-specified|Exploratory Outcomes|"Pain intensities on a 100 mm VAS with terminal descriptors of 'no pain' and 'worst pain possible' in various situations.~Number of sites with pain in the previous 24 hours shaded on a region-divided body chart~Pain location and type assessed using the Knee Pain Map.~Maximum isometric muscle strength (converted to Nm using the length of the lower leg) measured bilaterally in knee flexion and knee extension in a make test using a handheld dynamometer (Powertrack II TM Commander from JTech Medical Industries, Salt Lake City, Utah, USA)~Pressure pain thresholds measured bilaterally using a handheld algometer (Algometer Type II, Somedic AB, Hoerby, Sweden)) at five sites at the knee and the m. tibialis anterior muscle.~Self-efficacy in improving pain, function and QOL in various situations using a 100 mm VAS with terminal descriptors of 'very unsure' and 'very sure'.~Further exploratory objectives may be added later on."|Baseline, 3months, 6months, 12months and 24 months.|Will be reported in later publications, as it is exploratory outcomes||||||
2679530|NCT01410409|Secondary|Serious Adverse Events Related to the Index Knee|Adverse events (AE) and seriously adverse events (SAE) will be registered in three ways and divided into index knee or sites other than index knee. The project physiotherapist will record any adverse events that the participant experiences or tells them about. For the participants allocated to, or crossing over to, TKA, a project worker will look through hospital records to register if any pre-defined perioperative and postoperative adverse events occurred. At all follow-ups, the assessor will use open-probe questioning to assess adverse events in all participants|Primary: 12months||||Serious adverse events related to knee|||Number
2679531|NCT01410409|Secondary|Proportion of Users of Pain Medication|With possible answers being yes and no|Baseline and 12months.||||proportion of participants||95% Confidence Interval|Number
2679532|NCT01410409|Secondary|Weight Change in kg From Baseline|Weight change in kg measured without shoes at the same time of day and on the same scale|Primary: 12months.|Only patients with a BMI equal to or >25 were included in the analysis|||kg||95% Confidence Interval|Mean
2679533|NCT01410409|Secondary|Change in the Five Subscales of KOOS From Baseline|All subscales going from 0 to 100 (worst to best)|Primary: 12months.||||units on a scale||95% Confidence Interval|Mean
2679534|NCT01410409|Secondary|Change in 20-meter Walk From Baseline||Primary: 12months.||||sec||95% Confidence Interval|Mean
2679535|NCT01410409|Secondary|Change in Timed Up & Go (TUG) From Baseline||Primary: 12months.||||sec||95% Confidence Interval|Mean
2679536|NCT01410409|Secondary|Change in EQ-5D From Baseline|"Between groups comparisons of the change from baseline to the 1 year follow-up in all secondary endpoint will be handled similar to the primary endpoint. See Statistical analysis plan for further description (Links)~Range of EQ-5D Descriptive Index is -0.59 to 1.00 (worst to best), while the EQ VAS goes from 0 to 100 (worst to best)."|Primary: 12months.||||units on a scale||95% Confidence Interval|Mean
2679537|NCT01410409|Primary|Change in KOOS4 From Baseline (Knee Injury and Osteoarthritis Outcome Score)|The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best). Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority.|Primary: 12months.||||units on a scale||95% Confidence Interval|Mean
2679538|NCT01410357|Other Pre-specified|Comparison of PMHSMS (Perceived Mental Health Self-Management Scale) Score Between TTIM and TAU at 60 Weeks|The Perceived Mental Health Self-Management Scale is an 8-item Likert scale, with each question ranging from 1-5. Total summed scores range from 8-40, with higher scores indicating higher perceived self-management competence in regards to mental health.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.|||scores on a scale||Standard Deviation|Mean
2679539|NCT01410357|Other Pre-specified|Comparison of PDSMS (Perceived Diabetes Self Management Scale)Score Between TTIM and TAU at 60 Weeks|The Perceived Diabetes Self-Management Scale is an 8-item Likert scale, with each question ranging from 1-5. Items 1, 2, 6, and 7 are reverse coded. Total summed scores range from 8-40, with higher scores indicating higher perceived self-management competence in regards to diabetes.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 67 TTIM and 72 TAU.|||scores on a scale||Standard Deviation|Mean
2679540|NCT01410357|Other Pre-specified|Comparison of MSPSS (Multidimensional Scale of Perceived Social Support) Score Between TTIM and TAU at 60 Weeks|The Multidimensional Scale of Perceived Social Support is a 12 question Likert scale, with each item ranging from 1-5. Total scores range from 12-60, with higher scores indicating more perceived social support.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 73 TTIM and 74 TAU.|||scores on a scale||Standard Deviation|Mean
2679541|NCT01410357|Other Pre-specified|Comparison of Diabetes Knowledge Score Between TTIM and TAU at 60 Weeks|The diabetes knowledge score has 23 questions which assess how much knowledge one has about diabetes. They are in multiple choice format, with 4 choices, and only one is correct. The total amount correct is added up, and then calculated into a percentage of answers correct.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 73 TTIM and 74 TAU.|||percent correct||Standard Deviation|Mean
2679542|NCT01410357|Other Pre-specified|Comparison of Utilization (Mental Hospital) Score Between TTIM and TAU at 60 Weeks|The Utilization of Mental Hospital score looks at how many times a participant used these resources. Analyses include a simple mean and SD.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 73 TTIM and 74 TAU.|||time utilized||Standard Deviation|Mean
2679543|NCT01410357|Other Pre-specified|Comparison of Utilization (Mental Ed) Score Between TTIM and TAU at 60 Weeks|The Utilization of Mental Education score looks at how many times a participant used these resources. Analyses include a simple mean and SD.|60 weeks|While 76 completed TAU, there was some missing data for this scale, resulting in 74 TAU.|||times utilized||Standard Deviation|Mean
2679544|NCT01410357|Other Pre-specified|Comparison of Utilization (Phys Ed) Score Between TTIM and TAU at 60 Weeks|The Utilization of Physical Education score looks at how many times a participant used these resources. Analyses include a simple mean and SD.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 74 TTIM and 75 TAU.|||times utilized||Standard Deviation|Mean
2679545|NCT01410357|Secondary|Comparison of ISMI (Stigma Resistance) Score Between TTIM and TAU at 60 Weeks|The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Stigma Resistance, has 5 Likert-scale items. Each question is rated as 0= strongly disagree, 1= disagree, 2= neutral, 3= agree, 4= strongly agree. These scores are all reverse coded. Total scores on the Stigma Resistance subscale range from 0-20, with higher scores reflecting higher levels of reported internalized stigma of mental illness.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.|||scores on a scale||Standard Deviation|Mean
2679546|NCT01410357|Secondary|Comparison of ISMI (Social Withdrawal) Score Between TTIM and TAU at 60 Weeks|The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Social Withdrawal, has 6 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Social Withdrawal subscale range from 6-30, with higher scores reflecting higher levels of reported internalized stigma of mental illness.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.|||scores on a scale||Standard Deviation|Mean
2679547|NCT01410357|Secondary|Comparison of ISMI (Discrimination Experience) Between TTIM and TAU at 60 Weeks|The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Discrimination Experience, has 5 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Discrimination Experience subscale range from 5-25, with higher scores reflecting higher levels of reported internalized stigma of mental illness.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.|||scores on a scale||Standard Deviation|Mean
2679548|NCT01410357|Secondary|Comparison of ISMI (Stereotype Endorsement) Score Between TTIM and TAU at 60 Weeks|The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Stereotype Endorsement, has 7 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= agree, 4= strongly agree. Total scores on the Stereotype Endorsement subscale range from 7-28, with higher scores reflecting higher levels of reported internalized stigma of mental illness.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 69 TTIM and 74 TAU.|||scores on a scale||Standard Deviation|Mean
2679549|NCT01410357|Secondary|Comparison of ISMI (Internalized Stigma of Mental Illness -Alienation) Between TTIM and TAU at 60 Weeks|The ISMI (Internalized Stigma of Mental Illness) has 29 questions, broken into 5 subscales. This subscale, Alienation, has 6 Likert-scale items. Each question is rated as 1= strongly disagree, 2= disagree, 3= neutral, 4= agree, 5= strongly agree. Total scores on the Alienation subscale range from 6-30, with higher scores reflecting higher levels of reported internalized stigma of mental illness.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 70 TTIM and 74 TAU.|||scores on a scale||Standard Deviation|Mean
2679550|NCT01410357|Secondary|Comparison of AUDIT (Alcohol Use Disorders Identification Test) Score Between TTIM and TAU (Treatment as Usual) at 60 Weeks|The AUDIT scale (Alcohol Use Disorders Identification Test) has 10 questions, with scores on each question ranging from 0 to 4 (0= never, 1= less than monthly, 2= monthly, 3= weekly 4= daily/almost daily). Questions 9 and 10 only have three anchors: 0, 2, and 4. The scores are summed to get total. Therefore, the range of possible scores are 0-40, with higher scores indicating indicating a greater likelihood of hazardous and harmful drinking. However, such scores may also reflect greater severity of alcohol problems and dependence, as well as a greater need for more intensive treatment.|60 weeks|While 74 participants completed the TTIM arm and 76 completed TAU, there was some missing data for this scale, resulting in 69 TTIM and 73 TAU.|||Scores on a scale||Standard Deviation|Mean
2679551|NCT01410357|Secondary|Self-rated Diabetes Self-Care Activities (SDSCA) Questionnaire at 60 Weeks|The SDSCA measure is a brief self-report questionnaire of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking. It is comprised of 10 questions, to which each have a 5 point scale with anchors 1= never through 5= always. The items are summed to a total score, which ranges from 10-50.|60 weeks||||scores on a scale||Standard Deviation|Mean
2679552|NCT01410357|Secondary|Tablets Routine Questionnaire (TRQ) at 60 Weeks|The self-reported Tablets Routine Questionnaire (TRQ) measures change in treatment adherence. The TRQ determines proportion of prescribed medication missed, and ranges from 0 (no medication missed/100% adherent) to 100 (no medication taken/0% adherent). The TRQ format captured an exact proportion (%) of days with a missed medication dose for each oral maintenance psychotropic medication and then an average combined TRQ was calculated for all orally-prescribed medications.|60 weeks||||percentage of days adherent||Standard Deviation|Mean
2679553|NCT01410357|Primary|SF-36 Health Survey at 60 Weeks; Physical Health Component|The Short Form 36 Health Survey (SF-36) is a self-report of general health divided into a physical component summary (PCS) and mental component summary (MCS). Norm-based scores are placed on the same metric with a mean of 50 and standard deviation of 10. Scores above 50 reflect higher functional status than the average population and scores below 50 reflect lower than average function.|60 weeks||||scores on a scale||Standard Deviation|Mean
2679557|NCT01410357|Primary|SF-36 (Short-form) Health Survey at 60 Weeks; Mental Health Component|The Short Form 36 Health Survey (SF-36) is a self-report of general health divided into a physical component summary (PCS) and mental component summary (MCS). Norm-based scores are placed on the same metric with a mean of 50 and standard deviation of 10. Scores above 50 reflect higher functional status than the average population and scores below 50 reflect lower than average function.|60 weeks||||scores on a scale||Standard Deviation|Mean
2679558|NCT01410357|Primary|Sheehan Disability Scale (SDS) at 60 Weeks|The SDS measures role impairment in three domains (work/school; family life/home; social life). Possible total scores range from 0 to 30, with higher scores indicating greater disability. Only the total score was reported in our analyses, and is denoted here. The total score is calculated by summing the three domain scores, each which range from 0-10.|60 weeks||||scores on a scale||Standard Deviation|Mean
2679559|NCT01410357|Primary|Global Assessment of Functioning (GAF) at 60 Weeks|The GAF is a 100-point single-item scale that measures global functioning. Possible scores range from 1 to 100, with higher scores indicating better functioning.|60 weeks||||scores on a scale||Standard Deviation|Mean
2679560|NCT01410357|Primary|Clinical Global Impression (CGI) at 60 Weeks|The Clinical Global Impression (CGI) is a broad measure of global psychopathology that evaluates illness severity on a 1 to 7 point continuum. Possible scores range from 0 to 7, with higher scores indicating greater psychopathology.|60 weeks||||scores on a scale||Standard Deviation|Mean
2679561|NCT01410357|Primary|Montgomery Asberg Depression Rating Scale (MADRS) at 60 Weeks|The MADRS is a 10-item depression severity scale widely utilized in studies with patients with serious mental illness. Possible scores range from 0 to 60 with higher scores indicating worse depression.|60 weeks||||scores on a scale||Standard Deviation|Mean
2679562|NCT01410357|Primary|Brief Psychiatric Rating Scale (BPRS) at 60 Weeks|The BPRS measures psychotic and non-psychotic symptoms in serious mental illness. Possible total scores range from 7 to 126, with higher scores indicating greater symptom severity. For this study, the BPRS with 18 items was used. Each symptom measured ranges from 1-7, and all 18 items/symptoms are summed to create the total score. Only the BPRS total score was utilized in the analyses.|60 weeks||||scores on a scale||Standard Deviation|Mean
2679563|NCT01410344|Secondary|Infection Severity|The maximum grade of infections reported by participants are described, as defined in the BMT CTN Technical MOP.|1 Year Post-transplant||||Participants|||Count of Participants
2679564|NCT01410344|Secondary|Percentage of Participants With Chronic Graft-Versus-Host Disease (GVHD)|Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification.|1 Year Post-transplant||||percentage of participants||95% Confidence Interval|Number
2679565|NCT01410344|Secondary|Percentage of Participants With Acute Graft-Versus-Host Disease (GVHD)|"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL 1.2-3 mg/dL 2.3.01-6 mg/dL 3.6.01-15.0 mg/dL 4.>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4"|Day 100 Post-transplant||||percentage of participants||95% Confidence Interval|Number
2679566|NCT01410344|Secondary|Chimerism|Donor T-cell and myeloid chimerism will be described separately by conditioning regimen intensity (myeloablative or reduced intensity) according to proportions with mixed chimerism (5-95% donor cells out of all), full chimerism (>95% donor cells), or graft rejection (<5% donor cells).|Week 4, Day 100, and 6 months Post-transplant||||Participants|||Count of Participants
2679567|NCT01410344|Secondary|Percentage of Participants Recovering Hematologic Function|Recovery of hematologic function is described by the time to neutrophil and platelet recovery. Time to neutrophil recovery will be the first of three consecutive days of > 500 neutrophils/μL following the expected nadir. Time to platelet engraftment will be described by the date when platelet count is > 20,000/μL for the first of three consecutive labs with no platelet transfusions 7 days prior.|Days 28 and 100 Post-transplant||||percentage of participants|||Number
2679568|NCT01410344|Secondary|Disease Status|Patients will be assessed for disease status at Day 100 post-HCT, classified as complete remission, partial remission, stable disease, and relapse/progressive disease.|Day 100 Post-transplant||||Participants|||Count of Participants
2679569|NCT01410344|Secondary|Primary Cause of Death||Up to 2 Years Post-transplant||||Participants|||Count of Participants
2679570|NCT01410344|Secondary|Percentage of Participants With Relapse/Progression|Relapse/Progression is defined as relapse or progression of the primary malignancy.|1 Year Post-transplant||||percentage of participants||95% Confidence Interval|Number
2679571|NCT01410344|Secondary|Percentage of Participants With Overall Survival|Overall survival is defined as the time from transplant to death from any cause.|Six months, 1 Year, and 2 Years Post-transplant||||percentage of participants||95% Confidence Interval|Number
2679572|NCT01410344|Primary|Percentage of Participants With Non-Relapse Mortality|The events for non-relapse mortality are death due to any cause other than relapse of the underlying malignancy.|Day 100, 1 Year, and 2 Years Post-transplant||||percentage of participants||95% Confidence Interval|Number
2679573|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Had Someone Helping Them to Walk|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set|||participants|||Number
2679574|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Cannot Get Out of Bed|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set|||participants|||Number
2679575|NCT01410240|Secondary|Rehabilitation Parameter by Study Day- Number of Participants Who Were Using a Another Walking Device (Other Than a: Walker, Walking Cane, or Wheelchair)|The number of participants responding affirmative in their rehabilitation diaries for each day|60 days|Full Analysis Set|||participants|||Number
2679581|NCT01410240|Secondary|Proportion of Participants With Any Adverse Events or Serious Injuries During or After Surgery||Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6|"Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants"|||Proportion of participants||95% Confidence Interval|Number
2679582|NCT01410240|Secondary|Proportion of Participants With Wound Complications (ie, Hematoma, Cellulitis, Dehiscence, Superficial or Deep Infection, and Persistent Drainage)||Day 0; Post-operative Days 1, 3 and Weeks 1, 2, 6|"Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants"|||Proportion of participants||95% Confidence Interval|Number
2679583|NCT01410240|Secondary|Proportion of Participants With Transfusion Requirements||Intra-operative|"Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants"|||Proportion of participants||95% Confidence Interval|Number
2679584|NCT01410240|Secondary|Length of Hospital Stay||From the day of hospitalization to the day of discharge|Full Analysis Set|||Days||Standard Deviation|Mean
2679585|NCT01410240|Primary|Proportion of Participants Who Have Adverse Events Related to Investigational Product (IP)|"Proportion of Participants who have serious injuries (SIs) related to IP~Proportion of Participants who have non-serious adverse events (non-SAEs) related to IP"|Throughout the study period, 1 year and 4 months|"Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 12 Run-In participants"|||Proportion of participants||95% Confidence Interval|Number
2679586|NCT01410240|Secondary|Change From Baseline in SF-36 Scores at Postoperative Weeks 1, 2, and 6|"Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. Scores were included where data was available.~Change in SF-36 Scores From Baseline = (Postoperative Week 1,2, or 6 Scores) - (Baseline Scores)."|Baseline and Postoperative Weeks 1, 2, and 6||||Scores on a scale||Standard Deviation|Mean
2679587|NCT01410240|Secondary|Quality of Life (Utilizing the Short Form 36 Health Survey [SF-36]) Measured Preoperatively (Baseline), and Postoperatively at Week 1, 2, and 6|Physical Functioning (PF); Role Limitation Due to Physical Health (RP); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Role Limitation Due to Emotional Problems (RE); Mental Health (MH), Physical Component Score (PCS); Mental Component Score (MCS). Scores range 0-100, higher scores represent better health. There is no total overall score; scoring is done for subscores and summary scores. Scores were included where data was available.|Preoperative, and Postoperative Weeks 1, 2, and 6|Full Analysis Set|||Scores on a scale||Standard Deviation|Mean
2679588|NCT01410240|Secondary|Change From Baseline at Postoperative Day 3, Week 1, Week 2, and Week 6 in Western Ontario and McMaster Universities (WOMAC) Scores|"A well-validated scale to reflect problems in people with lower limb issues.~Pain scale (5 items): 0 (none) to 10 (extreme pain) is used to grade each item, higher scores indicate greater pain. The overall pain scale = 0 (no pain) to 50 (extreme pain)~Stiffness scale (2 items): 0 (none) to 10 (extreme stiffness) is used to grade each item, higher scores indicate greater stiffness. The overall stiffness scale = 0 (no stiffness) to 20 (extreme stiffness)~Physical Activity Difficulty (PAD) scale (17 items): 0 (none) to 10 (extreme PAD) is used to grade each item, with higher scores indicating greater PAD. The overall PAD scale = 0 (no PAD) to 170 (extreme PAD) Averages calculated by taking sum of all individual item scores listed above and dividing by total number of items, range = 0 (no issues) to 10 (extreme issues).~Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues).~Postoperative (Postop)"|Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6|Full Analysis Set|||score on a scale||Standard Deviation|Mean
2679589|NCT01410240|Secondary|Western Ontario and McMaster Universities (WOMAC) Function Index Scores|"A well-validated scale to reflect problems in people with lower limb issues.~Pain scale (5 items): 0 (none) to 10 (extreme pain) is used to grade each item, higher scores indicate greater pain. The overall pain scale = 0 (no pain) to 50 (extreme pain)~Stiffness scale (2 items): 0 (none) to 10 (extreme stiffness) is used to grade each item, higher scores indicate greater stiffness. The overall stiffness scale = 0 (no stiffness) to 20 (extreme stiffness)~Physical Activity Difficulty (PAD) scale (17 items): 0 (none) to 10 (extreme PAD) is used to grade each item, with higher scores indicating greater PAD. The overall PAD scale = 0 (no PAD) to 170 (extreme PAD)~Averages calculated by taking sum of all individual item scores listed above and dividing by total number of items, range = 0 (no issues) to 10 (extreme issues).~Total Scores calculated by taking sum of all individual item scores listed above, range = 0 (no issues) to 240 (extreme issues)~Postoperative (Postop)"|Pre-operatively (Day -1 to Day 0), and post-operatively at Day 3 and Week 1, 2 and 6|Full Analysis Set|||score on a scale||Standard Deviation|Mean
2679590|NCT01410240|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 6|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Week 6|Full Analysis Set|||score on a scale||Standard Deviation|Mean
2679591|NCT01410240|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 2|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Week 2|Full Analysis Set|||score on a scale||Standard Deviation|Mean
2679592|NCT01410240|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Week 1|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Week 1|Full Analysis Set|||score on a scale||Standard Deviation|Mean
2679593|NCT01410240|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Pain Scores at Postoperative Day 3|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3|Full Analysis Set|||score on a scale||Standard Deviation|Mean
2679594|NCT01410240|Secondary|Visual Analogue Scale (VAS) Pain Scores|Participant rated assessment of the level of pain they are experiencing with their operated knee. The VAS Pain Scale rates pain on a scale from 0 (no pain) to 10 (worst possible pain). For the pain scale, a higher score indicates worse pain.|Pre-operatively (Day -1 to Day 0) and post-operatively at Day 3, Week 1, 2 and 6|Full Analysis Set|||score on a scale||Standard Deviation|Mean
2679595|NCT01410240|Secondary|Pain Management - Number of Days When Pain Medication Was Used|"Each participant kept a knee pain management diary. The diary was used to document the pain medication taken on a daily basis.~While the participants were hospitalized, either they filled out the diary, or study team members collected the pain diary data and filled out the diary."|Pre-operatively (Day -1 to Day 0); and post-operatively daily thru week 6|Full Analysis Set|||days||Standard Deviation|Mean
2679596|NCT01410240|Secondary|Total Drain Output at Day 1 Post-operatively||1 day post-operatively|Full Analysis Set|||mL||Standard Deviation|Mean
2679597|NCT01410240|Secondary|Transfusion Requirements - Packed Red Blood Cells||Intra-operatively (Day 0) thru Postoperative Day 3|Full Analysis Set - participants with transfusion requirement|||mL||Standard Deviation|Mean
2679598|NCT01410240|Secondary|Duration of Surgery||Time from first incision to complete wound closure (Day 0)|Full Analysis Set|||minutes||Standard Deviation|Mean
2679599|NCT01410240|Secondary|Amount of FLOSEAL Applied||Intra-operatively (Day 0)|"Safety Analysis Set~Note: The FLOSEAL (+ Standard of Care (SoC)) Arm/Group Includes the 15 Run-In participants"|||mL||Standard Deviation|Mean
2679600|NCT01410240|Secondary|Total Tourniquet Time|Measured from the time point of the tourniquet inflation to deflation using the same watch/clock|Intra-operatively (on day of surgery = Day 0)|Full Analysis Set|||minutes||Standard Deviation|Mean
2679601|NCT01410240|Secondary|Change From Baseline in Hematocrit (Hct) at Postoperative Day 3||Pre-operative and day 3 post-operatively|"Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels."|||percent||Standard Deviation|Mean
2679602|NCT01410240|Secondary|Change From Baseline in Hematocrit (Hct) at Postoperative Day 2||Pre-operative and day 2 post-operatively|"Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels."|||percent||Standard Deviation|Mean
2679603|NCT01410240|Secondary|Change From Baseline in Hematocrit (Hct) at Postoperative Day 1|Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels.|Pre-operative and day 1 post-operatively|"Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hct levels."|||percent||Standard Deviation|Mean
2679604|NCT01410240|Secondary|Change in Hemoglobin (Hgb) Levels at Day 3 Post-operatively|Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels.|Pre-operative and day 3 post-operatively|"Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels."|||g/dL||Standard Deviation|Mean
2679605|NCT01410240|Secondary|Change in Hemoglobin (Hgb) Levels at Day 1 Post-operatively||Pre-operative and day 1 post-operatively|"Full Analysis Set~Participants who required a transfusion prior to the outcome assessments were excluded from the efficacy analyses of Hgb levels."|||g/dL||Standard Deviation|Mean
2679606|NCT01410240|Primary|Change in Hemoglobin (Hgb) Level at Day 2 Post-operatively||Pre-operative and 2 days post-operatively|"Full Analysis Set~Participants who required a transfusion prior to the primary outcome assessment of Hgb level at postoperative Day 2 were excluded from the primary outcome analysis."|||g/dL||Standard Deviation|Mean
2679607|NCT01410227|Secondary|PK80- Ratio of Intra-participant PK of VWF:RCo, VWF:Ag and VWF:CB at Baseline and After 6 Months|Area under the plasma concentration curve (AUC) from time 0 to infinity per dose (AUC0-∞/dose) for von Willebrand Factor Ristocetin cofactor (VWF:RCo), von Willebrand Factor Antigen (VWF:Ag) and von Willebrand Factor Collagen Binding (VWF:CB). Each parameter was compared between the two PK assessments after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. 13 participants had data available for this endpoint i.e. data for PK1 and PK2.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.|Participants from the PK80 Arm who had pharmacokinetic (PK) data available after both the first infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] [PK1] and the second infusion of 80 IU/kg rVWF [PK2].|||ratio of AUC0-∞/dose||90% Confidence Interval|Geometric Mean
2679608|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of FVIII:C|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of Factor VIII activity (FVIII:C) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679664|NCT01410227|Secondary|Percentage of Participants Who Develop Binding Antibodies to rFurin|The presence of total binding anti-rFurin antibodies was determined by measuring total immunoglobulin (Ig) antibodies (IgG, IgA, IgM) against rFurin protein using an enzyme-linked immunosorbent assay (ELISA). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of participants|||Number
2684211|NCT01369784|Secondary|Multiple Myeloma Oncogene 1 (MUM-1) Expression|immunohistochemical reaction of cells with MUM-1 antibody|At diagnosis||||percentage of participants|||Number
2679609|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of FVIII:C|Area under the plasma concentration curve (AUC) from time 0 to infinity of Factor VIII activity (FVIII:C) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679610|NCT01410227|Secondary|PK80 - Volume of Distribution at Steady State of VWF:CB|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg||95% Confidence Interval|Median
2679611|NCT01410227|Secondary|PK80 - Elimination Phase Half-Life of VWF:CB|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
2679612|NCT01410227|Secondary|PK80 - Incremental Recovery of VWF:CB|Incremental Recovery (IR) at the maximum plasma concentration Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679613|NCT01410227|Secondary|PK80 - Clearance of VWF:CB|Clearance (CL) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg/hours||95% Confidence Interval|Median
2679614|NCT01410227|Secondary|PK80 - Mean Residence Time of VWF:CB|Mean Residence Time (MRT) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
2679615|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:CB|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participatns from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679665|NCT01410227|Secondary|Percentage of Participants Who Develop Binding Antibodies to CHO|The presence of total binding anti-CHO antibodies was determined by measuring total immunoglobulin (Ig) antibodies (IgG, IgA, IgM) against Chinese Hamster Ovary (CHO) protein using an enzyme-linked immunosorbent assay (ELISA). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of participants|||Number
2679616|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:CB|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679617|NCT01410227|Secondary|PK80 - Volume of Distribution at Steady State of VWF:Ag|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg||95% Confidence Interval|Median
2679618|NCT01410227|Secondary|PK80 - Elimination Phase Half-Life of VWF:Ag|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
2679619|NCT01410227|Secondary|PK80 - Incremental Recovery of VWF:Ag|Incremental Recovery (IR) at the maximum plasma concentration Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679620|NCT01410227|Secondary|PK80 - Clearance of VWF:Ag|Clearance (CL) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg/hours||95% Confidence Interval|Median
2679621|NCT01410227|Secondary|PK80 - Mean Residence Time of VWF:Ag|Mean Residence Time (MRT) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
2679622|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:Ag|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679666|NCT01410227|Secondary|Percentage of Participants Who Develop Binding Antibodies to VWF|The presence of total binding anti-VWF antibodies was determined by an enzyme-linked immunosorbent assay (ELISA) employing polyclonal anti-human immunoglobulin (Ig) antibodies (IgG, IgM and IgA). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of participants|||Number
2679623|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:Ag|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Antigen (VWF:Ag) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679624|NCT01410227|Secondary|PK80 - Volume of Distribution at Steady State of VWF:RCo|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study. PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg||95% Confidence Interval|Median
2679625|NCT01410227|Secondary|PK80 - Elimination Phase Half-Life of VWF:Co|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
2679626|NCT01410227|Secondary|PK80 - Incremental Recovery of VWF:RCo|Incremental Recovery (IR) at the maximum plasma concentration Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679627|NCT01410227|Secondary|PK80 - Clearance of VWF:RCo|Clearance (CL) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg/hours||95% Confidence Interval|Median
2679628|NCT01410227|Secondary|PK80 - Mean Residence Time of VWF:RCo|Mean Residence Time (MRT) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
2679629|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:RCo|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679681|NCT01410110|Secondary|Attention Index|Index comprised on Trails A and Continuous Performance Test. T scores for the assessments are averaged. T scores range from 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 month and 6 month follow-up||||T Scores||Standard Deviation|Mean
2679630|NCT01410227|Secondary|PK80 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:RCo|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 80 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF] for participants in the PK80 arm (participants from Arm 3 with PK80 data only). PK assessment conducted at first infusion of 80 IU/kg rWVF [PK1] and the second infusion of 80 IU/kg rVWF after participants were treated on demand for bleeding episodes for at least 6 months since their first infusion of study product [PK2]. Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679631|NCT01410227|Secondary|PK50 - Volume of Distribution at Steady State of FVIII:C|Volume of Distribution at Steady State (Vss) of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg||95% Confidence Interval|Median
2679632|NCT01410227|Secondary|PK50 - Elimination Phase Half-Life of FVIII:C|Elimination Phase Half-Life (T1/2) of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant FVIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
2679633|NCT01410227|Secondary|PK50 - Incremental Recovery of FVIII:C|Incremental Recovery (IR) at the maximum plasma concentration of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679634|NCT01410227|Secondary|PK50 - Clearance of FVIII:C|Clearance (CL) of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg/hours||95% Confidence Interval|Median
2679635|NCT01410227|Secondary|PK50 - Mean Residence Time of FVIII:C|Mean Residence Time (MRT) of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] for participants in the PK50 arms (Arm 1 and Arm 2).|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
2679636|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of FVIII:C|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679637|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of FVIII:C|Area under the plasma concentration curve (AUC) from time 0 to infinity of Factor VIII activity (FVIII:C) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679638|NCT01410227|Secondary|PK50 - Volume of Distribution at Steady State of VWF:CB|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants[N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg||95% Confidence Interval|Median
2679639|NCT01410227|Secondary|PK50 - Elimination Phase Half-Life of VWF:CB|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant FVIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
2679640|NCT01410227|Secondary|PK50 - Incremental Recovery of VWF:CB|Incremental Recovery (IR) at the maximum plasma concentration of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679641|NCT01410227|Secondary|PK50 - Clearance of VWF:CB|Clearance (CL) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg/hours||95% Confidence Interval|Median
2679642|NCT01410227|Secondary|PK50 - Mean Residence Time of VWF:CB|Mean Residence Time (MRT) of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
2679643|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:CB|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679644|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:CB|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Collagen Binding (VWF:CB) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679645|NCT01410227|Secondary|PK50 - Volume of Distribution at Steady State of VWF:Ag|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg||95% Confidence Interval|Median
2679646|NCT01410227|Secondary|PK50 - Elimination Phase Half-Life of VWF:Ag|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant FVIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
2679677|NCT01410110|Secondary|Verbal and Visual Learning and Memory|Brief Visual-Spatial Memory Test (BVMT) and Hopkins Verbal Learning and Memory Test (HVLT). Total Score T Scores for tests were averaged. T score range is 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Months, 6 Months||||T Scores||Standard Deviation|Mean
2679647|NCT01410227|Secondary|PK50 - Incremental Recovery of VWF:Ag|Incremental Recovery (IR) at the maximum plasma concentration of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679648|NCT01410227|Secondary|PK50 - Clearance of VWF:Ag|Clearance (CL) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg/hours||95% Confidence Interval|Median
2679649|NCT01410227|Secondary|PK50 - Mean Residence Time of VWF:Ag|Mean Residence Time (MRT) of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII] or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
2679650|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:Ag|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679651|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:Ag|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Antigen (VWF:Ag) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679652|NCT01410227|Secondary|PK50 - Volume of Distribution at Steady State of VWF:RCo|Volume of Distribution at Steady State (Vss) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg||95% Confidence Interval|Median
2679653|NCT01410227|Secondary|PK50 - Elimination Phase Half-Life of VWF:Co|Elimination Phase Half-Life (T1/2) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant FVIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
2679654|NCT01410227|Secondary|PK50 - Incremental Recovery of VWF:RCo|Incremental Recovery (IR) at the maximum plasma concentration of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679678|NCT01410110|Secondary|Processing Speed Index|Wechsler Adult Intelligence Scale (WAIS) Digit Coding and Symbol Search. T scores for the assessments are averaged. T scores range from 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Months, 6 Months||||T Scores||Standard Deviation|Mean
2679655|NCT01410227|Secondary|PK50 - Clearance of VWF:RCo|Clearance (CL) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||dL/kg/hours||95% Confidence Interval|Median
2679656|NCT01410227|Secondary|PK50 - Mean Residence Time of VWF:RCo|Mean Residence Time (MRT) of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||hours||95% Confidence Interval|Median
2679657|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to 96 Hours (AUC0-96h/Dose) of VWF:RCo|Area under the plasma concentration curve (AUC) from time 0 to 96 hours of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for participants in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679658|NCT01410227|Secondary|PK50 - Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity (AUC0-∞/Dose) of VWF:RCo|Area under the plasma concentration curve (AUC) from time 0 to infinity of von Willebrand Factor Ristocetin cofactor (VWF:RCo) after infusion of 50 IU/kg recombinant von Willebrand Factor:von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) (ratio of 1.3:1±0.2) [rVWF:rFVIII], or 50 IU/kg VWF:RCo rVWF administered together with saline (placebo) [rVWF] for subjects in the PK50 arms (Arm 1 and Arm 2). Category title includes number of participants [N] who provided data for the category.|PK evaluations at pre-infusion, then at 15, 30 and 60 mins, and 3, 6, 12, 24, 30, 48, 72 and 96 hrs post-infusion. PK evaluation timeframe for 28 ± 3 days after first infusion of study product which includes PK evaluation for both infusions and washout.||||(hours*U/dL)/(U VWF: RCo/kg)||95% Confidence Interval|Median
2679659|NCT01410227|Secondary|Number of Adverse Events by Infusion Related to Study Product Including Clinically Significant Changes in Laboratory Parameters and Vital Signs|Adverse Events (AEs) by infusion related to study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are described. Only laboratory parameters (hematology and clinical chemistry) and vital signs (physical examination, ECG) with clinically significant findings that are recorded as AEs are included. Categories presented as Severity-System Organ Class-Preferred Term Seriousness: serious adverse event (SAE); non serious adverse event (nsAE) System Organ Class: Cardiac disorders (CARD); General disorders and administration site conditions (GEN); Investigations (INV); Nervous system disorders (NERV); Skin and subcutaneous tissue disorders (SKN); Vascular disorders (VAS).|For 12 months after first infusion of rVWF:rFVIII or rVWF||||Number of Adverse Events|Infusions||Number
2679660|NCT01410227|Secondary|Number of Participants With Adverse Events Related to Study Product Including Clinically Significant Changes in Laboratory Parameters and Vital Signs|Number of participants with Adverse Events (AEs) related to study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are described. Only laboratory parameters (hematology and clinical chemistry) and vital signs (physical examination, ECG) with clinically significant findings that are recorded as AEs are included. Categories presented as Severity-System Organ Class-Preferred Term Seriousness: serious adverse event (SAE); non serious adverse event (nsAE) System Organ Class: Cardiac disorders (CARD); General disorders and administration site conditions (GEN); Investigations (INV); Nervous system disorders (NERV); Skin and subcutaneous tissue disorders (SKN); Vascular disorders (VAS).|For 12 months after first infusion of rVWF:rFVIII or rVWF||||Number of participants|||Number
2679661|NCT01410227|Secondary|Number of Adverse Events Related to Study Product Including Clinically Significant Changes in Laboratory Parameters and Vital Signs|Adverse Events (AEs) related to study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are described. Only laboratory parameters (hematology and clinical chemistry) and vital signs (physical examination, ECG) with clinically significant findings that are recorded as AEs are included. Categories presented as Severity-System Organ Class-Preferred Term Seriousness: serious adverse event (SAE); non serious adverse event (nsAE) System Organ Class: Cardiac disorders (CARD); General disorders and administration site conditions (GEN); Investigations (INV); Nervous system disorders (NERV); Skin and subcutaneous tissue disorders (SKN); Vascular disorders (VAS). Category title includes number of AEs [N] for the category.|For 12 months after first infusion of rVWF:rFVIII or rVWF||||Number of Adverse Events|Adverse Events||Number
2679662|NCT01410227|Secondary|Percentage of Participants Who Had an Occurrence of Thrombotic Events||After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of participants|||Number
2679663|NCT01410227|Secondary|Percentage of Participants Who Develop Binding Antibodies to Mouse Immunoglobulin|The presence of total binding anti-Murine immunoglobulin (IgG) antibodies was determined using an enzyme-linked immunosorbent assay (ELISA). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of participants|||Number
2684212|NCT01369784|Secondary|p53 Expression|immunohistochemical reaction of cells with p-53 antibody|At the beginning of the 2nd line of treatment||||percentage of participants|||Number
2679667|NCT01410227|Secondary|Percentage of Participants Who Develop Inhibitory Antibodies to VWF|Neutralizing antibodies (inhibitors) to Von Willebrand Factor Ristocetin cofactor (VWF:RCo), VWF collagen binding (VWF:CB) and VWF Factor VIII binding (VWF:FVIIIB) activities were measured using Nijmegen modification of the Bethesda assay. One Bethesda Unit (BU) is thereby defined as the amount of inhibitor that decreased the measured activity in the assays to 50% of that of the negative control samples. The assays were validated using human plasma samples from two type 3 VWD patients with low (1-2 BU/mL) and high (~10 BU/mL) titer inhibitors and plasma samples from non-human primates immunized with human rVWF (>100 BU/mL). Category title includes number of participants [N] who provided data for the category.|After signing informed consent until 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of participants|||Number
2679668|NCT01410227|Secondary|Percentage of Participants Who Develop Inhibitory Antibodies to FVIII|Development of neutralizing antibodies (inhibitors) to factor VIII (FVIII) was assessed by the Nijmegen modification of the Bethesda assay. Positive FVIII inhibitor tests were defined as ≥ 0.4 Bethesda units/mL (BU/mL) by the Nijmegen-modified Bethesda assay that is confirmed by a second test performed on an independent sample obtained 2-4 weeks following the first test. Category title includes number of participants [N] who provided data for the category.|For 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of participants|||Number
2679669|NCT01410227|Secondary|Number of Units of rVWF:rFVIII and/or rVWF Per Bleeding Episode|The number of units is provided as the actual dose [IU/kg] of recombinant von Willebrand factor:recombinant factor VIII (rVWF:rFVIII) and/or rVWF required to treat a bleeding episode (BE). BEs were to be initially treated with an infusion of rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels, if available. In cases, where no FVIII levels were available, the individual participant's PK data was used to determine the rFVIII dose. The data set included prospectively estimated BEs treated with study product of known lot number with an available efficacy rating from participants in the Full Analysis Set.|For 12 months after first infusion of rVWF:rFVIII or rVWF||||IU/kg|Bleeding episodes|90% Confidence Interval|Median
2679670|NCT01410227|Secondary|Number of Infusions of rVWF:rFVIII and/or rVWF Per Bleeding Episode|The actual number of infusions of recombinant von Willebrand factor:recombinant factor VIII (rVWF:rFVIII) and/or rVWF required to treat a bleeding episode (BE). BEs were to be initially treated with an infusion of rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels, if available. In cases, where no FVIII levels were available, the individual participant's PK data was used to determine the rFVIII dose. The data set included prospectively estimated BEs treated with study product with an available efficacy rating from participants in the Full Analysis Set.|For 12 months after first infusion of rVWF:rFVIII or rVWF||||Number of infusions|Bleeding episodes|90% Confidence Interval|Median
2679671|NCT01410227|Secondary|"Percentage of Treated Bleeding Episodes With an Efficacy Rating of Excellent or Good, Excluding Gastrointestinal Bleeds"|"Efficacy ratings of excellent or good for the control of bleeding episodes (BEs) with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are defined as follows: Excellent - actual infusions ≤ estimated number of infusions required to treat BE; no additional von Willebrand Factor (VWF) required (all BEs); Good - >1-2 infusions (minor/moderate BEs) or <1.5 infusions (major BEs) greater than estimated required to control BE; no additional VWF required (all BEs). The data set included prospectively estimated BEs excluding gastrointestinal (GI) bleeds treated with study product with an available efficacy rating from participants in the Full Analysis Set."|For 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of bleeding episodes|Bleeding episodes|90% Confidence Interval|Geometric Mean
2679672|NCT01410227|Secondary|"Percentage of Treated Bleeding Episodes With an Efficacy Rating of Excellent or Good"|"Efficacy ratings excellent or good for the control of bleeding episodes (BEs) with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) are defined as follows: Excellent - actual infusions ≤ estimated number of infusions required to treat BE; no additional von Willebrand Factor (VWF) required (all BEs); Good - >1-2 infusions (minor/moderate BEs) or <1.5 infusions (major BEs) greater than estimated required to control BE; no additional VWF required (all BEs). The data set included prospectively estimated BEs treated with study product with an available efficacy rating from participants in the Full Analysis Set"|For 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of bleeding episodes|Bleeding episodes|90% Confidence Interval|Number
2679673|NCT01410227|Primary|Percentage of Participants With Treatment Success for Treated Bleeding Episodes|Treatment success was defined as the extent of control of bleeding episodes (BEs) using a mean efficacy rating score of <2.5 for a participant's BEs treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) during the study period. Scores used: Excellent = 1 - actual infusions ≤ estimated number of infusions required to treat BE; no additional VWF required (all BEs); Good = 2 - >1-2 infusions (minor/moderate BEs) or <1.5 infusions (major BEs) greater than estimated required to control BE; no additional VWF required (all BEs); Moderate = 3 ≥ 3 infusions (minor/moderate BEs) or ≥ 1.5 infusions (major BEs) greater than estimated required to control BE; no additional VWF required (all BEs); None = 4 - severe uncontrolled bleeding or intensity of bleeding not changed; additional VWF required. Included participants with available primary efficacy rating (prospective-excluding gastrointestinal bleeds) in the Full Analysis Set.|For 12 months after first infusion of rVWF:rFVIII or rVWF||||Percent of participants||90% Confidence Interval|Number
2679674|NCT01410110|Secondary|Global Index|Comprised of the average of 5 Index T Scores (Attention, Processing Speed, Visual and Verbal Memory and Learning, Working Memory and Executive Function). T Scores range from 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Months, 6 Months||||T Scores||Standard Deviation|Mean
2679675|NCT01410110|Secondary|Executive Function|Mazes, Wisconsin Card Sorting Task (WCST) Perseverative Error, Non-Perseverative Error, Conceptual Level. T Scores for each variable were averaged together. T Scores have a range of 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Months, 6 Months||||T Scores||Standard Deviation|Mean
2679676|NCT01410110|Secondary|Verbal and Visual Working Memory|WAIS Digit Span and Wechsler Memory Scale (WMS) Spatial Span. T Scores are averaged. T Scores range from 30 to 80 with a mean of 50. Higher scores are better.|Baseline, 3 Month, 6 Months||||T Scores||Standard Deviation|Mean
2679679|NCT01410110|Primary|Weeks of Sobriety|0 to 26 Weeks. Higher number of Weeks is better.|26 weeks|1 additional participant in Work Therapy Only had missing data for this variable.|||Weeks||Standard Deviation|Mean
2679682|NCT01410110|Primary|Days of Sobriety in First 90 Days|Abstinence will be determined by toxicology screening, breathalyzer and substance abuse calendar weekly during 3 months of active intervention. Days of sobriety has a range of 0 to 90 with higher being a better outcome.|3 months||||Days of Sobriety||Standard Deviation|Mean
2679683|NCT01410097|Secondary|Modified Mini-Mental Status Exam (3MS)|The Modified Mini-Mental Status Exam (3MS) was used to assess global cognitive function. Scores range from 0 to 100 with higher scores indicating better cognitive function. Assessed 8 or 9 years post-randomization in Look AHEAD parent Study.|Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978)|||Score on a scale||Standard Deviation|Mean
2679684|NCT01410097|Secondary|Modified Stroop Color and Word Test|The Modified Stroop Color and Word Test was used to assess executive function. The test measures a participant's ability to view complex visual stimuli and to respond to one stimulus dimension while suppressing response to another competitive stimulation. The participant first reads aloud words denoting colors printed in black ink (Subtest 1), then names aloud the color of blocks printed in colored ink (Subtest 2), and finally names aloud the color ink in which the words are printed in which are incongruent to the word (Subtest 3). The amount of time to complete each subtest and the number of errors are recorded and interference calculated as time to complete Subtest 3 - Subtest 1 + errors (lower interference scores indicate better cognitive performance). Assessed 8 or 9 years post-randomization in Look AHEAD parent Study.|Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978)|||score on a scale||Standard Deviation|Mean
2679685|NCT01410097|Secondary|Rey Auditory Verbal Learning Test (RAVLT)|The Rey Auditory Verbal Learning Test (RAVLT) was used to assess verbal memory. The participant is read a list of 15 words five times. After each time the list is given, the participant is asked to immediately recall as many words as possible. Following the fifth recall, an interference list is presented, after which the participant is asked to spontaneously recall words from the original list. After a 10-minute interval has passed, the participant is asked again to recall as many words as possible from the original list. The number of words correctly recalled on the delayed recall were used in the analysis (range, 0-15; higher number correct indicates better performance). Assessed 8 or 9 years post-randomization in Look AHEAD parent Study.|Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978)|||number correct||Standard Deviation|Mean
2679686|NCT01410097|Secondary|Digit Symbol Substitution Test (DSST)|The Digit Symbol Substitution Test (DSST) was used to assess working memory. Participants were presented with a legend at the top of the page showing the boxes each with a number from 1 to 9 and below each numbered box is a unique symbol. As rapidly as possible, the participant fills in the randomly ordered boxes with numbers paired with blank boxes with the symbol that corresponds to the number in the legend. The score is the total number of correctly entered symbols completed in 90 seconds (range, 0-133; higher score indicates better performance). Assessed 8 or 9 years post-randomization in Look AHEAD parent Study.|Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978)|||number correct||Standard Deviation|Mean
2679687|NCT01410097|Secondary|Trail Making Test (Part A & B)|Trail Making Tests A and B was used to assess attention and concentration (Part A) and executive function (Part B). Part A measures the time (in seconds) to draw lines to connect circled numbers in a numerical sequence and Part B measures the time (in seconds) to draw lines to connect circled numbers and letters in an alternating numeric and alphabetic sequence as rapidly as possible. The difference (in seconds; greater time indicates worse performance) in performance on Part B minus Part A was used in analysis to represent the contrast between performance on the simple (Part A) and alternating conditions (Part B). Assessed 8 or 9 years post-randomization in Look AHEAD parent Study.|Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Only participants who attended the ancillary clinic visit and completed the cognitive battery were included in the analysis (n=978)|||secs||Standard Deviation|Mean
2679688|NCT01410097|Secondary|Knee Extensor Strength|Maximum knee extensor strength (one repetition maximum (1RM)) was assessed on a Nautilus One™ Leg Extension machine. Participants with prior knee surgery on both knees where all or part of the joint was replaced were excluded from testing. The right leg was tested unless there was a contraindication (e.g., prior knee surgery). If participants experienced knee pain during the test and there were no contraindications to test the other leg, the other leg was tested; if participants experienced knee pain on the other leg, the test was terminated. Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Only participants who attended the ancillary clinic visit and were able to achieve maximum knee extensor strength (1RM) were included in the analysis (n=701)|||kg||Standard Deviation|Mean
2679689|NCT01410097|Secondary|Grip Strength|Grip strength (kg) was measured twice in each hand using an isometric Hydraulic Hand Dynamometer (Jamar, Bolingbrook, IL). The maximum of the force from two trials for the stronger hand was used in the analyses. Participants with severe hand pain or recent surgery in both hands were excluded from testing. Assessed 8 or 9 years post-randomization in Look AHEAD parent Study.|Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Only participants who attended the ancillary clinic visit and were able to do the grip strength test were included in the analysis (n=907)|||kg||Standard Deviation|Mean
2679690|NCT01410097|Secondary|Gait Speed Over 400 m|A 400 m walk was administered to assess endurance. Participants were instructed to walk at their usual pace and time to complete the 400-m walk was recorded. The 400-m walk test was terminated if the participant reported chest pain, tightness or pressure, significant shortness of breath or difficulty breathing, feeling faint, lightheaded or dizzy, or other pain (e.g., leg pain).Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Only participants who attended the ancillary clinic visit and were able to complete the 400 m walk were included in the analysis (n=869)|||m/sec||Standard Deviation|Mean
2679726|NCT01409434|Primary|Fasting Glucose (mg/dL)||Fasting glucose was obtained at time 0 min.|A total of 44 patients were included in the study, however 4 patients were treated with anti-diabetic medications and so were excluded from the analysis. Therefore there are a total of 40 patients that were included in the analysis.|||mg/dL||Standard Deviation|Mean
2679691|NCT01410097|Primary|Short Physical Performance Battery (SPPB) Score|The Short Physical Performance Battery (SPPB) was administered to assess lower extremity physical performance and consisted of standing balance tasks (side-by-side, semi- and full-tandem stands for 10 seconds each), time to complete 5 repeated chair stands, and a 6-m walk to assess usual gait speed. Each of the three performance measures was assigned a score ranging from 0 (inability to perform the task) to 4 (the highest level of performance) and summed to create an SPPB score ranging from 0 to 12 (best). Assessed 8 or 9 years post-randomization in Look AHEAD parent Study.|Assessed 8 or 9 years post-randomization in Look AHEAD parent Study|Only participants who attended the ancillary clinic visit and were able to do the SPPB were included in the analysis (n=954)|||Score on a scale||Standard Error|Mean
2679692|NCT01410084|Secondary|Number of Participants Who Were Compliant to Intervention|Number of participants who consumed at least 4 out of a possible 5 supplement doses (=>80% compliance) over 5 months.|5 months|Compliance assessed in participants who remained in the study over the 5 month intervention for an analysis sample of 64 participants.|||Participants|||Count of Participants
2679693|NCT01410084|Secondary|Number of Falls|Determine the effectiveness of the intervention on reducing the number of falls using monthly fall calendars (compare the average number of falls in vitamin D3 group vs. active placebo group over 5 months)|5 months||||falls/participant||Full Range|Mean
2679694|NCT01410084|Primary|Change in 25-hydroxyvitamin D Levels Over 5 Months|Determine the effectiveness of the intervention on improving 25-hydroxyvitamin D levels (change in 25(OH)D from baseline to 5-month follow-up). Measured as 5-month follow-up 25(OH)D level minus baseline 25(OH)D level.|5 months|Participants who did not have a 5 month follow-up visit (n=4) and those who did not have baseline and/or follow-up blood samples (n=7) were excluded from the analysis leaving an analysis sample of 57 participants|||ng/mL||Standard Error|Mean
2679695|NCT01410058|Other Pre-specified|Cmax|Maximum plasma concentration post does, determined using a non-compartmental approach by means of the Phoenix WinNonlin software application. Time points for sample collection were 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h|Baseline (day 22), Post-moringa (day 35)|Only patients with complete data were included.|||microgram/mL||Geometric Coefficient of Variation|Geometric Mean
2679696|NCT01410058|Secondary|C12h|plasma concentration 12h post dose, determined using a non-compartmental approach by means of the Phoenix WinNonlin software application. Time points for sample collection were 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h|Baseline (Day 22); Post-moringa (Day 35)|Only patients with complete data were included in the analysis.|||microgram/mL||Geometric Coefficient of Variation|Geometric Mean
2679697|NCT01410058|Primary|AUC|Area under the plasma concentration time curve, determined using a non-compartmental approach by means of the Phoenix WinNonlin software application. Time points for sample collection were 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h|Baseline (day 22), Post-moringa (day 35)|Only participants with complete data were included|||h*microgram/mL||Geometric Coefficient of Variation|Geometric Mean
2679698|NCT01409993|Secondary|Blood Pressure|Systolic blood pressure|3 months||||mmHg||Standard Deviation|Mean
2679699|NCT01409993|Secondary|Fasting Plasma Glucose||3 months||||mg/dL||Standard Deviation|Mean
2679700|NCT01409993|Primary|Glucose Infusion Rate|In the group of subjects undergoing euglycemic clamp (Aim 2)|2.5 hours after 3 months of therapy|one subject in the sildenafil Aim 2 arm has incomplete data from the three-month clamp due to infusion dysfunction|||mL/hr||Standard Deviation|Mean
2679701|NCT01409993|Primary|Index of Tissue Sensitivity to Insulin|in the group of subjects undergoing hyperglycemic clamp (Aim 1), calculated by dividing the average glucose infusion rate during the last hour of the clamp by the average plasma insulin concentration during the same interval|2.5 hours after 3 months of therapy||||(mg/kg/min per microU/mL)*100||Standard Error|Mean
2679702|NCT01409993|Primary|Insulin Secretion|in the group of subjects undergoing hyperglycemic clamp (Aim 1)|2.5 hours after 3 months of therapy|Glucose-stimulated insulin secretion from 90 to 120 minutes of hyperglycemic clamp|||microU/mL||Standard Error|Mean
2679703|NCT01409928|Primary|Change in Body Mass Index Z-score|Measure of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.|12 months post operation||||Z-score||Standard Deviation|Mean
2679704|NCT01409837|Primary|Proportion of Sperm Cells With Abnormal Morphology (%)|The proportion (per cent) of the total number of sperm cell with abnormal appearance.|Week 282|All the patients who were randomized into each group were analyzed on the basis of intention-to-treat.|||Per cent||Standard Deviation|Geometric Mean
2679705|NCT01409837|Primary|Proportion of Sperm Cells With Normal Motility (%)|The proportion (per cent) of the sperm cells exhibiting both rhythmic and propulsive movements considered to be of normal intensity.|Week 282|All the patients who were randomized into each group were analyzed on the basis of intention-to-treat|||Per cent||Standard Deviation|Geometric Mean
2679706|NCT01409837|Primary|Total Sperm Cell Count|The total number of sperm cells found in each milliliter of seminal fluid.|Week 282|All the patients who were randomized into each group were analyzed on the basis of intention-to-treat.|||Millions/ml||Standard Deviation|Geometric Mean
2679707|NCT01409837|Primary|Ejaculate Volume|The volume in milliliters of seminal fluid produced per ejaculation.|Week 282|All the patients who were randomized into eacg group was analyzed on the basis of intention-to-treat|||ml||Standard Deviation|Geometric Mean
2679708|NCT01409837|Primary|Proportion of Sperm Cells With Abnormal Morphology (%)|Proportion (per cent) of sperm cells with abnormal appearance|Week 96|All the patients randomized into each group was analyzed on the basis of intention-to-treat.|||per cent||Standard Deviation|Geometric Mean
2679709|NCT01409837|Primary|Proportion of Sperm Cells With Normal Motility (%)|This was determined as the proportion (percent) of the total sperm cells exhibiting both rhythmic and propulsive movements considered to be of normal intensity.|Week 96|All the patients randomized into each group was analyzed on the basis of intention-to-treat|||Per cent||Standard Deviation|Geometric Mean
2679710|NCT01409837|Primary|Total Sperm Cell Count Per Milliliter of Seminal Fluid.|the number of sperm cells counted per milliliter volume of seminal fluid|Week 96|All the patients randomized into each group were analyzed on the basis of intention-to-treat|||Millions/ml||Standard Deviation|Mean
2684213|NCT01369784|Secondary|p-53 Expression|immunohistochemical reaction of cells with p-53 antibody|At diagnosis||||percentage of participants|||Number
2679711|NCT01409837|Secondary|Adverse Events Monitoring|The patients were encouraged to report every event promptly by phone to one of the authors (NOG), no matter however minor.Blood pressure measurements were done with mercury sphygmomanometers fitted with adult-size cuffs (Accoson, England). Serum potassium levels were estimated using the flame photometric method as described by Davidson and Henry|At weeks 6, 12, 24, 48, 96, 102, 114,138, 186 and 282|All the patients who were randomized into each group were monitored for adverse events.|||participants|||Number
2679712|NCT01409837|Primary|Changes From Baseline in the Seminal Fluid Characteristics Throughout the Study|The seminal fluid characteristics were assessed twice before the entry of each patient and both at least two-weeks apart. The two values were averaged and recorded as baseline for week 0 while subsequent changes from the baseline were monitored during each of the scheduled visits at weeks 6, 12, 24, 48, 96, 102, 114, 138, 186 and 282. The two groups swopped treatments at the 96th week. The number of pregnancies achieved was also documented throughout the study period.|Week 96.|All the patients randomized into each group were included in the analysis on the basis of intention-to-treat (last value carried forward)|||ml||Standard Deviation|Geometric Mean
2679713|NCT01409811|Primary|Mean (SE) Change From Pre-Treatment Baseline in (Log)pg/mL of Biomarker, by Time, Adjusted for Level at Baseline|After the trial's premature closure, no data were collected for the primary endpoints; however, data on 14 of 30 secondary endpoints were obtained and are summarized below. Serum level (pg/mL) per biomarker was log-transformed. Change from baseline over time was evaluated using a generalized linear mixed model where follow-up time was represented by terms for the sequence of post-baseline samples or for (log)day on study. To recognize regression to the mean across repeated samples, a term for biomarker level at baseline, with or without interaction by time, was included when it improved the model's fit to the observed data. With 14 biomarkers sampled twice after baseline, there were 28 evaluations of change in biomarker level with exposure to study drug. Therefore, to control the False Discovery Rate (FDR), only evaluations that maintained the study's FDR at no more than 5 percent were accepted as true.|"48-72 hrs and Surgery (10-23 days)"|The analysis included data from all evaluable subjects.|||Change from Baseline in (log)pg/mL||Standard Error|Mean
2679714|NCT01409707|Primary|Timeline Follow Back|The timeline follow back is a measure of drug and alcohol consumption in the prior 90 days. The timeline follow back is a calendar-based retrospective account of drug and alcohol consumption for a specified period of time (e.g., past 90 days). One of the most commonly reported metrics of drug and alcohol consumption from this measure is percent days abstinent (PDA). Percent days abstinent is simply the proportion of days for the specified period of time (e.g., 90 days) in which drugs or alcohol were not consumed. Percent days abstinent can range from 0 to 100 with 0 representing no abstinence during a specified period of time (i.e., consumed alcohol every day) and 100 representing complete abstinence during a specified period of time.|3-months posttreatment|All participants who started the study were included in the analyses (ITT). Missing data were estimated using maximum likelihood estimation.|||percentage of days abstinent||Standard Error|Mean
2679715|NCT01409707|Primary|Impact of Event Scale-Revised|The Impact of Event Scale-Revised is a 22-item self-report measure of posttraumatic stress disorder symptoms. The total score for the Impact of Event Scale-Revised ranges from 0 to 88 with lower scores representing less severe symptoms of posttraumatic stress disorder and higher scores representing more severe symptoms of posttraumatic stress disorder.|3-months posttreatment|All participants who started the study were included in the analyses (ITT). Missing data were estimated using maximum likelihood estimation.|||units on a scale||Standard Error|Mean
2679716|NCT01409564|Secondary|Fazekas Scale|"Level of severity of white matter lesions in AD patients who can be legitimately administered with cilostazol. Measured by professionally trained clinicians.~The higher score indicates more severe white matter lesion. Max-min: 0-3"|Baseline||||participants|||Number
2679717|NCT01409564|Secondary|Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)|"Measured by professionally trained clinicians. Higher score indicates more severe AD symptoms.~Score Scale: 0-18 (min-MAX)"|Baseline, 12-month, 24-month||||units on a scale||Standard Deviation|Mean
2679718|NCT01409564|Secondary|Activities of Daily Living (ADCS-ADL)|"The caregiver answered to the questions given to measure the cognitive function level of the patients in daily living. Lower scores indicate greater severity.~23 questions Score Scale: 0-78 (min-MAX)"|Baseline, 12-month, 24-month||||units on a scale||Standard Deviation|Mean
2679719|NCT01409564|Secondary|Mini-Mental State Examination (MMSE) in the Korean Version of the CERAD Assessment Packet)|Basic cognitive functions are checked. (0-30) The score is better when higher.|Baseline, 12-month, 24-month||||units on a scale||Standard Deviation|Mean
2679720|NCT01409564|Secondary|Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog)|"The ADAS-Cog score is measured by the number of questions answered incorrectly, therefore the higher is the worse.~Score Scale: 0-75 (min-MAX)~Each subcategory scores are summed.~Word-recall test (0-10)~Commands (0-5)~Constructional praxis (0-5)~Naming Objects/ Fingers (0-5)~Ideational Praxis (0-5)~Orientation (0-8)~Word Recognition (0-12)~Remembering Test Instructions (0-5)~Spoken Language Ability (0-5)~Word Finding Difficulty (0-5)~Comprehension (0-5)"|Baseline, 12-week, 24-week||||units on a scale||Standard Deviation|Mean
2679721|NCT01409564|Primary|Regionally Averaged Cerebral Glucose Uptake Changes Measured by FDG PET Uptake With Voxel-based Method|Regional cerebral glucose uptake level was measured as the ratio value of FDG uptake of the each unit level to the global mean uptake value.|Baseline, 24-week|Number of patients with increased whole brain glucose uptake level. In the real analysis, however, a voxel-based image analysis results were used; therefore, data which can be entered here is not much meaningful.|||Bq/Bq (no unit)||Standard Deviation|Mean
2679722|NCT01409434|Secondary|High Density Lipoprotein (mg/dL)||High Density Lipoprotein was obtained at time 0 min.||||mg/dL||Standard Deviation|Mean
2679723|NCT01409434|Secondary|Low Density Lipoprotein (mg/dL)||Low Density Lipoprotein was obtained at time 0 min.||||mg/dL||Standard Deviation|Mean
2679724|NCT01409434|Secondary|Triglycerides (mg/dL)||Triglycerides was obtained at time 0 min.||||mg/dl||Standard Deviation|Mean
2679725|NCT01409434|Secondary|Oral Glucose Tolerance Test (mg/dl h)|Area under the curve for the OGTT was calculated for each patient using the 3 time points (0 hour, 1 hour and 2 hour). Average value for participants is provided.|one oral glucose tolerance test was performed with 3 time points (0 hour, 1 hour, 2 hour)|Patients that underwent an OGTT|||mg/dL*h||Standard Deviation|Mean
2684227|NCT01369732|Primary|Incidence of Acute Kidney Injury Based on RIFLE Criteria||upto 7 days after surgery||||participants|||Number
2679728|NCT01409382|Secondary|Refractory Hypoglycemia|"Any glucose level ≤ 40/dL at 1, 2 or 4 h:~Neonates with hypoglycemia (glucose level equal or below 40 mg/dL at 1, 2 or 4 h) will be offered milk. Neonates unable to suckle, will be treated with intravenous dextrose for one hour.~A new heel stick blood sample will be drawn to assess glucose levels.~Neonates with persistent hypoglycemia will be considered as refractory hypoglycemia."|One hour after feeding or after intravenous dextrose|All hypoglycemic neonates were screened for refractory hypoglycemia. Only neonates born to mothers who were physically inactive and reported excessive carbohydrate consumption displayed refractory hypoglycemia.|||neonates with refractory hypoglycemia|||Number
2679729|NCT01409382|Primary|Neonatal Hypoglycemia|Any glucose level equal or below 40mg/dL at 1, 2 or 4 h after birth, obtained by heelstick.|1, 2 and 4 h after birth.||||neonates|Participants||Number
2679730|NCT01409291|Secondary|Fast Food Meals Per Week|Mean number of fast food meals per week|1 year||||meals per week||Standard Deviation|Mean
2679731|NCT01409291|Primary|Minutes of Exercise Per Week|Mean minutes of exercise per week|1 year||||minutes||Standard Deviation|Mean
2679732|NCT01409239|Primary|Difference Between Heart Rate Variability Between Intravenous and Subcutaneous Group|difference in mean low frequency/high frequency heart rate variability (LF/HF HRV)at 6 hour. 2 patients were excluded who did not have usable LF/HF HRV data at 6 hours. These patients remained in the study as they did have other measures.|6 hour||||none (ratio)||Inter-Quartile Range|Median
2679733|NCT01409213|Primary|Change From Baseline for Mean Fasting Blood Glucose (FBG)|Change from baseline was defined as mean FBG baseline value minus mean FBG end of observation value.|Baseline and end of Observation (up to Month 6)|Participants from the full analysis set with available data.|||mg/dL||Standard Deviation|Mean
2679734|NCT01409213|Primary|Change From Baseline for Mean Hemoglobin A1c (HbA1C)|Change from baseline was defined as mean HbA1c baseline value minus the mean HbA1c end of observation value.|Baseline and end of Observation (up to Month 6)|Participants from the full analysis set with available data.|||Percent of glycosylated hemoglobin||Standard Deviation|Mean
2679735|NCT01409096|Secondary|Hamilton Rating Scale for Anxiety (HRSA)|"The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).~Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where less than 17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe."|12 weeks||||units on a scale||Standard Error|Least Squares Mean
2679736|NCT01409096|Secondary|Young Mania Rating Scale (YMRS)|"This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).~Score:~Minimum: 0 Maximum: 60 Lower score associated with better outcome"|12 weeks||||units on a scale||Standard Error|Least Squares Mean
2679737|NCT01409096|Secondary|Inventory of Depressive Symptomatology-Self Report (IDS-SR)|"IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode.~Score:~Minimum: 0 Maximum: 84 Lower score associated with better outcome"|12 weeks||||units on a scale||Standard Error|Least Squares Mean
2679738|NCT01409096|Primary|The 17-item Hamilton Rating Scale for Depression (HRSD17)|"The HRSD is an observer-rated measure of depressive symptomatology.~Minimum: 0; Maximum: 50; Better outcome: lower score; Normal score: 7 or less."|12 weeks||||units on a scale||Standard Error|Least Squares Mean
2679739|NCT01409031|Secondary|Duration of Mechanical Ventilation||Participants will be on mechanical ventilation an average of 1 week|This trial was terminated early due to lack of recruitment. No participants completed the study. Data required to assess this outcome measure was not collected.||||||
2679740|NCT01409031|Secondary|Age at Hospital Discharge||Participants will be followed for the duration of hospital stay, an expected average of 3 weeks|This trial was terminated early due to lack of recruitment. No participants completed the study. Data required to assess this outcome measure was not collected.||||||
2679741|NCT01409031|Secondary|Duration of Supplemental O2||Participants will be on supplemental O2 an average of 2 weeks|This trial was terminated early due to lack of recruitment. No participants completed the study. Data required to assess this outcome measure was not collected.||||||
2679742|NCT01409031|Secondary|Change in Pulmonary Arterial Pressure|Change in pulmonary arterial pressure as calculated by echocardiography|Baseline and 4 hours post study drug administration|This trial was terminated early due to lack of recruitment. No participants completed the study. Data required to assess this outcome measure was not collected.||||||
2679743|NCT01409031|Primary|Receipt of Standard Therapy at Any Point During the 7-day Treatment Period|Receipt of standard therapy (inhaled nitric oxide [iNO] and/or extracorporeal membrane oxygenation [ECMO]) at any point during the 7-day treatment period|7-day treatment period|This trial was terminated early due to lack of recruitment. No participants completed the study. Data required to assess this outcome measure was not collected.||||||
2679744|NCT01409031|Primary|Improvement in Oxygenation||From baseline values at 4 and 24 hours|This trial was terminated early due to lack of recruitment. No participants completed the study. Data required to assess this outcome measure was not collected.||||||
2679745|NCT01408992|Primary|Standard Hearing Test|Hearing loss is defined as an elevation, at least more than 25 dB of air-conduction, pure tone average threshold at speech frequencies. The severity loss is categorized into mild (26-40 dB), moderate (41-55 dB), moderately severe (56-74 dB), severe (75-90 dB), and profound (>90 dB). In this study, we aim to use FMHT as a screening tool for hearing disability (Better hearing ear has hearing threshold greater than 40 dB).|Baseline||||participants|||Number
2679746|NCT01408992|Post-Hoc|Sensitivity of FMHT to Detect the Hearing Loss.|"FMHT has 15 questions and there are 4 possible answer for each question. The best possible answer is never and is scored 0, occasionally is scored 1, half the time is scored 2 and almost always the worst answer is scored 3. The total possible range for the FMHT scores 0-45. We then compared the total score with the better hearing ears as in Outcome measure 1. The total number of participants with a score from 0 to 45, and that all participants in the study had a score within this range. It would appear, from information provided in the previous version of this record, that the total score might range from 0 to 45."|baseline|The frequencies of subjects who had FMHT score from 0 to 45 were counted.|||participants|||Number
2679747|NCT01408992|Secondary|Prevalence of Ear Diseases|the frequency of diseased ears per the total examined ears|Immediate||||ears|Participants||Number
2679748|NCT01408914|Secondary|Incidence of Rifampin-related Grade 2 or Higher Adverse Events|Number of participants experiencing at least one rifampin-related grade 2 or higher adverse events during the initial 8 weeks of treatment and up to four weeks after.|Throughout the 12 weeks post treatment initiation||||Participants|||Count of Participants
2679749|NCT01408914|Secondary|Sputum Culture Sterilization During the Initial 8 Weeks of Treatment|Number of participants that are sputum culture (in LJ) negative for TB at 8 weeks|Until 8 weeks of treatment are completed||||Participants|||Count of Participants
2679750|NCT01408914|Primary|Steady State Pharmacokinetic Exposure of RIF|The endpoint is the (dimensionless) ratio of AUC0-6 mcg/ml*h to MIC99.9 mcg/ml|At any time during the intensive phase of treatment, after steady state has been reached (at a minimum, after 14 days of daily RIF delivery)|Analysis was completed in 168 participants evaluable for pharmacokinetics, as samples were unable to be collected in 12 study participants.|||Ratio||Inter-Quartile Range|Median
2679751|NCT01408901|Secondary|Change in CD34_CD45lo_CD31_CD133_ at 12-week Follow-up|"Red blood cells are lysed twice with freshly prepared lysis buffer. Remaining cells are stained with LIVE/DEAD® Fixable Dead Cell Stains for 20 minutes at room temperature and Fc receptors are blocked by incubating with Fc receptor blocking reagent for 10 minutes at 4oC. Samples are then stained with the following antibody cocktail for 30 minutes at 4oC: CD34 VioBlue, CD133-APC , CD45 AlexaFluor 700, and CD31 (PECAM-1) APC-eFluor® 780. Stained samples are acquired using a BD LSRII and analyzed using Flowjo software.~The outcome is the absolute change in the percentages of cells."|change from baseline to week 12|Note: It is pre-specified in the study protocol that investigators will determine whether a supervised treadmill exercise intervention alone (Group C) is associated with greater increases in CD34+ cells at 12-week follow-up, compared to Group D. Therefore, only group C and group D are included here.|||percentage of cells||95% Confidence Interval|Mean
2679752|NCT01408901|Secondary|Change in CD34_CD45lo_CD31_ at 12-week Follow-up|"Red blood cells are lysed twice with freshly prepared lysis buffer. Remaining cells are stained with LIVE/DEAD® Fixable Dead Cell Stains for 20 minutes at room temperature and Fc receptors are blocked by incubating with Fc receptor blocking reagent for 10 minutes at 4oC. Samples are then stained with the following antibody cocktail for 30 minutes at 4oC: CD34 VioBlue, CD133-APC , CD45 AlexaFluor 700, and CD31 (PECAM-1) APC-eFluor® 780. Stained samples are acquired using a BD LSRII and analyzed using Flowjo software.~The outcome is the absolute change in the percentages of cells."|change from baseline to week 12|Note: It is pre-specified in the study protocol that investigators will determine whether a supervised treadmill exercise intervention alone (Group C) is associated with greater increases in CD34+ cells at 12-week follow-up, compared to Group D. Therefore, only group C and group D are included here.|||percentage of cells||95% Confidence Interval|Mean
2679753|NCT01408901|Secondary|Change in CD34_CD45loCD133_ at 12-week Follow-up|"Red blood cells are lysed twice with freshly prepared lysis buffer. Remaining cells are stained with LIVE/DEAD® Fixable Dead Cell Stains for 20 minutes at room temperature and Fc receptors are blocked by incubating with Fc receptor blocking reagent for 10 minutes at 4oC. Samples are then stained with the following antibody cocktail for 30 minutes at 4oC: CD34 VioBlue, CD133-APC , CD45 AlexaFluor 700, and CD31 (PECAM-1) APC-eFluor® 780. Stained samples are acquired using a BD LSRII and analyzed using Flowjo software.~The outcome is the absolute change in the percentages of cells."|change from baseline to week 12|Note: It is pre-specified in the study protocol that investigators will determine whether a supervised treadmill exercise intervention alone (Group C) is associated with greater increases in CD34+ cells at 12-week follow-up, compared to Group D. Therefore, only group C and group D are included here.|||percentage of cells||95% Confidence Interval|Mean
2679754|NCT01408901|Secondary|Change in CD34_CD45lo at 12-week Follow-up|"Red blood cells are lysed twice with freshly prepared lysis buffer. Remaining cells are stained with LIVE/DEAD® Fixable Dead Cell Stains for 20 minutes at room temperature and Fc receptors are blocked by incubating with Fc receptor blocking reagent for 10 minutes at 4oC. Samples are then stained with the following antibody cocktail for 30 minutes at 4oC: CD34 VioBlue, CD133-APC , CD45 AlexaFluor 700, and CD31 (PECAM-1) APC-eFluor® 780. Stained samples are acquired using a BD LSRII and analyzed using Flowjo software.~The outcome is the absolute change in the percentages of cells."|change from baseline to week 12|Note: It is pre-specified in the study protocol that investigators will determine whether a supervised treadmill exercise intervention alone (Group C) is associated with greater increases in CD34+ cells at 12-week follow-up, compared to Group D. Therefore, only group C and group D are included here.|||percentage of cells||95% Confidence Interval|Mean
2679755|NCT01408901|Secondary|Change in Maximal Treadmill Walking Time at 12-week Follow-up|The Gardner graded treadmill exercise test is the standard, accepted treadmill protocol for measuring change in maximal treadmill walking time in response to interventions among PAD participants. In the Gardner exercise protocol, speed is maintained at 2.0 miles per hour (mph) and treadmill grade increases by 2.0% every two minutes. If patients cannot begin walking at 2.0 mph, treadmill speed is started at 0.50 mph and increased by 0.50 mph every 2 minutes until the participant reaches 2.0 mph, after which the treadmill grade is increased every two minutes.|change from baseline to week 12|Data were imputed for participants who were lost to follow-up or who canceled the visit. Variables used for imputation were age, ankle brachial index, body mass index, sex, race, smoking status, baseline outcome values, leg symptoms, and comorbidities. SAS procedure MI was used to obtain 20 imputed data sets.|||minutes||95% Confidence Interval|Mean
2679756|NCT01408901|Secondary|Change in Brachial Artery Flow-mediated Dilation (FMD) at 12-week Follow-up|The brachial artery is imaged 5 to 9 cm above the antecubital fossa using a linear array vascular ultrasound transducer. Three video sequences are obtained. The first verifies the location and baseline hemodynamic state of the brachial artery. The second begins 20 seconds before cuff inflation and continues for 10 seconds after inflation. The third begins 15 seconds before cuff release and continues for 90 seconds after deflation. Brachial artery FMD is calculated as the percent change in brachial artery diameter at 60 seconds and at 90 seconds after the release of the cuff.|change from baseline to week 12|Data were imputed for participants who were lost to follow-up or who canceled the visit. Variables used for imputation were age, ankle brachial index, body mass index, sex, race, smoking status, baseline outcome values, leg symptoms, and comorbidities. SAS procedure MI was used to obtain 20 imputed data sets.|||percent change||Inter-Quartile Range|Median
2679811|NCT01408043|Secondary|Correlation of Peripheral CD34+ Cell Count With Graft Content of CD34+ Cells|Correlation of peripheral CD34+ cell count with graft content of CD34+ cells assessed using Spearman correlation.|Up to 28 days post treatment|No data collected for this outcome due to low accrual||||||
2679757|NCT01408901|Primary|Change in Six-Minute Walk Performance at 12-week Follow-up|In the six-minute walk, participants walk back and forth along a 100-ft hallway for six minutes after standardized instructions to complete as many laps as possible. Distance covered in six minutes is recorded.|change from baseline to week 12|Data were imputed for participants who were lost to follow-up or who canceled the visit. Variables used for imputation were age, ankle brachial index, body mass index, sex, race, smoking status, baseline outcome values, leg symptoms, and comorbidities. SAS procedure MI was used to obtain 20 imputed data sets.|||meters||95% Confidence Interval|Mean
2679758|NCT01408888|Secondary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of LY2189265||Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2|Participants who received at least one dose of LY2189265 with evaluable LY2189265 tmax data.|||hours||Full Range|Median
2679759|NCT01408888|Secondary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY2189265||Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2|Participants who received at least one dose of LY2189265 with evaluable LY2189265 Cmax data.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2679760|NCT01408888|Secondary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY2189265|Area under the LY2189265 pharmacokinetic (PK) concentration versus time curve (AUC [0-tau]) during one dosing interval (168 hours) is summarized.|Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2|Participants who received at least one dose of LY2189265 with evaluable LY2189265 AUC data.|||nanograms times hour/milliliter(ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2679761|NCT01408888|Secondary|Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Sitagliptin||Predose and up to 24 hours post dose on Day 4, Day 6, and Day 13 of Treatment 2|Participants who received at least one dose of sitagliptin with evaluable sitagliptin tmax data|||hours||Full Range|Median
2679762|NCT01408888|Primary|Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Sitagliptin||Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2|Participants who received at least one dose of sitagliptin with evaluable sitagliptin Cmax data.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2679763|NCT01408888|Primary|Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Sitagliptin|Area under the sitagliptin pharmacokinetic (PK) concentration versus time curve (AUC [0-tau]) during one dosing interval (24 hours) is summarized.|Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2|Participants who received at least one dose of sitagliptin with evaluable sitagliptin AUC data.|||nanograms times hour/milliliter(ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2679764|NCT01408862|Primary|Changes in Basal or Aggregant-induced Platelet Activation (With and Without Glucose Added to the Media, 200 mg/dl, 400 mg/dL) by GLP-1-(7-36)NH2 and Its Metabolite (GLP-1-(9-36)NH2)and a GIP Agonist at Different Concentrations.|"1 Direct effect of GLP-1-(7-36)NH2 and its metabolite (GLP-1-(9-36)NH2) and GIP agonist on platelet aggregation, with and without preincubation at different glucose concentrations.~2. GLP-1-(7-36)NH2 and its metabolite (GLP-1-(9-36)NH2) and GIP agonist modulation (with and without 300 mg/dL glucose added to the media) of platelet activation and aggregation induced by classical platelet agonists such as ADP, collagen and bovine von Willebrand factor.~Data points from various conditions were combined (averaged),"|Platelets drawn from a volunteer will be evaluated 1 time (in 1-2 days)|We assume that with 10 samples per condition divided in 5 categories (1 control plus 4 concentrations of GLP1 and GIP agonists) for a standardized difference of 0.5 between groups and a p=0.05, the statistical power would be higher than 90%. We used a similar design to test the effect of GLP1 and GIP agonists on platelet aggregants.|||% of Inhibition||Standard Deviation|Mean
2679765|NCT01408862|Primary|Expression of Glucagon Like Peptide -1 (GLP-1) and Gastric Inhibitory Peptide (GIP) Receptors in Normal Human Platelets|1.1 Measurement of GLP-1 and GIP receptors at the platelet RNA level by Real Time-PCR 1.2 GLP-1 and GIP receptors detection at the protein level: 1.2.1 Expression on platelet membrane by flow cytometry. 1.2.2 Detection in total platelet proteins by western-blot. Data of flow cytometry are provided below|Platelets drawn from a volunteer were evaluated 1 time (in 1-2 days)||||percentage of positive cells||Standard Deviation|Mean
2679766|NCT01408732|Primary|Severityof Epistaxis|The primary outcome measure will be severity of epistaxis as measured by the Epistaxis Severity Score (ESS). The ESS, a recently developed online questionarrie that calculates the grading system for epistaxis severity. The higher the score the more severe the nose bleeds are Scale consists of several questions with a range of scale from 0-5 The average score is calculated for a final assessment|Change from Baseline to 14 weeks||||units on a scale||Standard Deviation|Mean
2679767|NCT01408719|Secondary|Changes in Body Weight and Waist Circumference(WC)|Body weight will be monitored every day when subject visits the Richardson Centre. Waist circumference will be measured at the beginning and end of each study phase.|Every day for body weight; beginning and end of each phase for WC|||||||
2679768|NCT01408719|Primary|Changes in LDL Cholesterol|Serum LDL cholesterol will be estimated using the Friedewald equation.|Beginning and end of each phase|||||||
2679769|NCT01408719|Secondary|Potential Gene-nutrient Interactions: CYP7A1 and APOE|The Single Nucleotide Polymorphism (SNP) rs3808607 of CYP7A1 gene, rs429358 and rs7412 of APOE gene, and their associations with different blood lipid responses to beta-glucan interventions will be determined.|Once for each participant|||||||
2679770|NCT01408719|Secondary|Cholesterol Absorption/Synthesis|The rate of cholesterol absorption and synthesis will be measured in each intervention phase using single stable isotope labelling technique.|End of each phase|||||||
2679771|NCT01408719|Primary|Changs in Total Cholesterol|Fasted total cholesterol concentration will be measured using the automated enzymatic methods.|Beginning and end of each phase||||mmol/L||Standard Error|Least Squares Mean
2679772|NCT01408706|Secondary|Patient Expression of Discomfort|Patient expression of discomfort was scored for each insertion by the treating radiation therapist on a scale from 1(none) to 5(intolerable). An average score was obtained at completion of therapy for each patient. At completion of the study, an average value was obtained for each immobilization device by averaging the average score for each patient .|Up to nine weeks||||units on a scale||Full Range|Mean
2679856|NCT01407575|Primary|UKU Side Effect Rating Scale|measure of side effects 46 items with scores of 0,1,2,3 possible. Theoretical range 0-138 Lower scores indicate fewer side effects|6 weeks||||units on a scale||Standard Deviation|Mean
2679773|NCT01408706|Secondary|Difficulty of Insertion.|Difficulty of device insertion was scored for each treatment by the treating radiation therapist on a scale from 1(easiest) to 5(most difficult). An average score was obtained at completion of therapy for each patient. At completion of the study, an average value was obtained for each immobilization device by averaging the average score for each patient .|Up to nine weeks||||units on a scale||Full Range|Mean
2679774|NCT01408706|Primary|Deviation of the Prostate Rectal Interface From Its Position at Time of Simulation.|Measurements will be taken for at least 5, and up to 9, occasions on a weekly basis during each patient's course of treatment. An average value will be determined for each patient. An average of individual patient values will be determined for each immobilization device.|Up to 9 weeks||||CENTIMETERS||Standard Deviation|Mean
2679775|NCT01408641|Secondary|Amount of PTSD Symptoms|The Clinician Administered PTSD Scale (CAPS) contains 30 questions relating to PTSD symptoms. Each question asks about both the frequency and the severity of each symptom. These questions are split into categories. Each criterion has several questions, and scores for each criterion are added up at the end. To meet criteria for a symptom, a patient must meet criteria in both frequency and intensity score for each item. Frequency and intensity and then combined to form a single severity score. Severity scores range from 0-4, with 0 being absent to 4 being extreme/incapacitating.|14 weeks|There were not enough interested, eligible participants available to continue the study. Additionally, the study drug expired and the pharmacy that had done the compounding was bought by a larger chain and was set to be closed. Therefore, the study was stopped and closed in April 2013.||||||
2679776|NCT01408641|Primary|Percentage of Heavy Drinking Days|The Alcohol Timeline Follow Back (TLFB) interview was conducted to establish a baseline drinking pattern over the previous 90 days and confirm the presence of an alcohol use disorder (defined as consumption of greater than 35 standard drinks per week over the previous 4 weeks). The TLFB involves asking participants to retrospectively report their drinking days using a calendar.|14 weeks|There were not enough interested, eligible participants available to continue the study. Additionally, the study drug expired and the pharmacy that had done the compounding was bought by a larger chain and was set to be closed. Therefore, the study was stopped and closed in April 2013.||||||
2679777|NCT01408628|Secondary|Severity of Self-reported Hypoglycemia|Severity was defined by the scale used by the DCCT: grade 1 - subject was able to recognize and treat appropriately without assistance; grade 2 - subject required help from another person either to recognize or recognize/treat; grade 3 - subject required injection of glucagon or treatment in ER|6 Months|Subjects who completed both the Internet intervention and the 6 months of follow up|||incidents (count)|||Number
2679778|NCT01408628|Secondary|Change in HbA1c|Change in HbA1c (average measure of the % of glycosolated hemoglobin in the blood over the past 3 months) from baseline to end of follow up period.|Change from Baseline through Month 6 of follow-up period|Subjects who both completed the Internet intervention and the six months of follow up|||percentage of glycosolated hemoglobin||Standard Deviation|Mean
2679779|NCT01408628|Primary|Frequency of Hypoglycemia|Hypoglycemia was defined in the study as either a blood glucose reading <70 mg/dL or symptomatic to the patient/subject.|6-month follow up period following the Internet Intervention|Subjects who both completed the Internet intervention AND the 6 months of follow up|||incidents per person-year||Standard Deviation|Mean
2679780|NCT01408576|Secondary|The Percent of Subjects Meeting Treatment Response Criteria According to a Combined Response Index|Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.|Week 96|The Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365) or SL0010 (NCT01261793) prior to enrollment in SL0012, and with available results at the Week 96 time-point.|||percentage of participants|||Number
2679781|NCT01408576|Secondary|Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index|Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.|Week 96|The Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365) or SL0010 (NCT01261793) prior to enrollment in SL0012, and with available results at the Week 96 time-point.|||Participants|||Count of Participants
2679782|NCT01408576|Secondary|Percentage of Subjects Meeting Treatment Response Criteria According to a Combined Response Index|Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.|Week 48|The Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365) or SL0010 (NCT01261793) prior to enrollment in SL0012.|||percentage of participants|||Number
2679783|NCT01408576|Secondary|Number of Subjects Meeting Treatment Response Criteria According to a Combined Response Index|Combined response index is a response variable (yes/no) incorporating the following criteria for achievement of responder status (ie, all criteria must be met to achieve responder status): (1) British Isles Lupus Activity Group (BILAG) improvement, (2) No worsening in Systemic Lupus Erythematosus Activity Index (SLEDAI), (3) No worsening in Physician's Global Assessment of Disease, and (4) No disallowed changes in concomitant medications, with disallowed changes including mainly increases in corticosteroids, immunosuppressants, and antimalarials.|At Week 48|The Full Analysis Subset 1 (FASS1) consisted of all subjects in the FAS who were enrolled in study SL0008 (NCT00660881), SL0009 (NCT01262365) or SL0010 (NCT01261793) prior to enrollment in SL0012.|||Participants|||Count of Participants
2679784|NCT01408576|Primary|Percentage of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)|"A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes:~Death~Life-threatening~Significant or persistent disability/incapacity~Congenital anomaly/birth defect (including that occurring in a fetus)~Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious~Initial inpatient hospitalization or prolongation of hospitalization"|During the treatment period (through Week 96)|Safety Set (SS) which consisted of all subjects who had received at least 1 partial dose of study medication during SL0012. A partial dose of study medication was defined as any infusion during which the subject received >0mL of study medication.|||percentage of participants|||Number
2679785|NCT01408576|Primary|Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 96 Weeks)|"A SAE is a treatment-emergent adverse event (TEAE) that the investigator classifies as serious. This includes:~Death~Life-threatening~Significant or persistent disability/incapacity~Congenital anomaly/birth defect (including that occurring in a fetus)~Important medical event that, based upon appropriate medical judgment, may jeopardize the patient or subject and may require medical or surgical intervention to prevent 1 of the other outcomes listed in the definition of serious~Initial inpatient hospitalization or prolongation of hospitalization"|During the treatment period (through Week 96)|Safety Set (SS) which consisted of all subjects who had received at least 1 partial dose of study medication during SL0012. A partial dose of study medication was defined as any infusion during which the subject received >0mL of study medication.|||Participants|||Count of Participants
2679786|NCT01408576|Primary|Percentage of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)|A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.|During the treatment period (through Week 96)|Safety Set (SS) which consisted of all subjects who had received at least 1 partial dose of study medication during SL0012. A partial dose of study medication was defined as any infusion during which the subject received >0mL of study medication.|||percentage of participants|||Number
2679787|NCT01408576|Primary|Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (Maximum 96 Weeks)|A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.|During the treatment period (through Week 96)|Safety Set (SS) which consisted of all subjects who had received at least 1 partial dose of study medication during SL0012. A partial dose of study medication was defined as any infusion during which the subject received more than (>) 0mL of study medication.|||Participants|||Count of Participants
2679788|NCT01408563|Secondary|Median Thrombopoietin Levels After Transplant||30 Days||||pg/mL||Full Range|Median
2679789|NCT01408563|Secondary|Rate of Post-transplant Lymphoma|The number of participants that were found to have lymphoma post-transplant.|2.5 years||||Participants|||Count of Participants
2679790|NCT01408563|Secondary|1 Year Relapse Rate|The percentage of participants that relapsed within 12 months. Relapse is defined by either morphological or cytogenetic evidence of the original malignancy consistent with pre-transplant features.|1 year||||percentage||95% Confidence Interval|Number
2679791|NCT01408563|Secondary|Overall Survival|The percentage of participants alive at two years|2 years|The two participants found to be ineligible after being consented and registered were excluded from the analysis.|||percentage of participants||95% Confidence Interval|Number
2679792|NCT01408563|Secondary|Relapse-free Survival|The percentage of participants that have not died or had disease progression by two years. Relapse is defined by either morphological or cytogenetic evidence of the original malignancy consistent with pre-transplant features.|2 years|The two participants found to be ineligible after being consented and registered were excluded from the analysis.|||percentage of participants||95% Confidence Interval|Number
2679793|NCT01408563|Secondary|Immune Reconstitution - Median CD4 Count at 12 Months||1 Year|CD4 counts were only available for 11 participants at the 12 months time point|||cells/mm3||Full Range|Median
2679794|NCT01408563|Secondary|100-day Treatment Related Mortality|The percentage of treatment related participant deaths within 100 days of receiving umbilical cord blood transplantation. All deaths in the absence of relapse of the primary malignancy will be considered treatment related mortality.|100 Days|The two participants found to be ineligible after being consented and registered were excluded from the analysis.|||percentage of participants||95% Confidence Interval|Number
2679795|NCT01408563|Secondary|The Rate of Chronic GVHD|Chronic Graft Versus Host Disease (GVHD) is assessed using the National Institutes of Health (NIH) consensus criteria.|From the time of transplantation until the time of chronic GVHD onset, up to 1 year|The two participants found to be ineligible after being consented and registered were excluded from the analysis.|||percentage of participants||95% Confidence Interval|Number
2679796|NCT01408563|Secondary|Rates of Grade II-IV and Grade III-IV Acute Graft Versus Host Disease (GVHD) at 100 Days|"Acute GVHD is assessed using Consensus Criteria:~Organ Classifications:~0: No rash due to GVHD; Bilirubin < 2 mg/dL; < 500 mL diarrhea/ day~1: Maculopapular rash < 25% of body surface; Bilirubin 2-3 mg/dL; 500 to 999 mL diarrhea/ day or persistent nausea with histologic evidence of GVHD in stomach/ duodenum~2: Maculopapular rash 25-50% of body surface; Bilirubin 3.1-6 mg/dL; 1,000 to 1,499 mL diarrhea/ day~3: Maculopapular rash > 50% of body surface; Bilirubin 6.1-15 mg/dL; 1,500 or more mL diarrhea/ day~4: Generalized erythroderma with bullous formation; Bilirubin > 15 mg/dL; Severe abdominal pain with or without ileus~Overall Clinical Grade:~0: No Stage 1-4 of any organ~I: Stage 1-2 rash and no liver or gut involvement~II: Stage 3 rash, or Stage 1 liver involvement, or Stage 1 gut involvement~III: None to Stage 3 skin rash with Stage 2-3 liver involvement, or Stage 2-4 gut involvement~IV: Stage 4 skin rash, or Stage 4 liver involvement"|100 Days|The two participants found to be ineligible after being consented and registered were excluded from the analysis.|||percentage of participants||95% Confidence Interval|Number
2679797|NCT01408563|Secondary|Number of Participants With Primary Graft Failure|Primary graft failure is defined as the failure to achieve an absolute neutrophil count (ANC) >500/ µL by day 42, in the absence of relapse.|From the time of transplantation until 42 days post transplantation||||Participants|||Count of Participants
2679798|NCT01408563|Secondary|Median Time to Platelet Engraftment|The time to platelet engraftment is measured from the time of transplantation until the time of first documented platelet engraftment. Platelet engraftment is defined as a platelet count ≥ 20,000/µL for three consecutive measurements over three or more days. The first of the three days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 3 days or in the following 7 days after the day of engraftment, unless the platelet transfusion is being given specifically to achieve a platelet threshold to allow an elective invasive procedure, such as a central catheter removal.|From the time of transplantation, until the time of platelet engraftment, median duration of 52 days|The two participants found to be ineligible after being consented and registered were excluded from the analysis. In addition to those two participants, the 10 participants that did not achieve engraftment were not included in the analysis.|||Days||Full Range|Median
2679799|NCT01408563|Secondary|Median Time to Neutrophil Engraftment|The median number of days measured from the time of transplantation, until the first documented neutrophil engraftment. neutrophil engraftment is defined as the first of 3 consecutive days of absolute neutrophil count > 500 neutrophils per microliter of blood.|From the time of transplantation, until the time of neutrophil engraftment, median duration of 24 days|The two participants found to be ineligible after being consented and registered were excluded from the analysis. In addition to those two participants, the 8 participants that did not achieve engraftment were not included in the analysis.|||Days||Full Range|Median
2679800|NCT01408563|Primary|Number of Participants With a Clinically Significant Infection|The one year significant infection rate (infections requiring medical intervention) after double umbilical cord blood transplant using a novel conditioning regimen of fludarabine/melphalan/low dose total body radiation. The data is shown as the number of significant infections participants experienced during the first year, measured from the start of treatment.|1 Year|The two participants found to be ineligible after being consented and registered were excluded from the analysis.|||Participants|||Count of Participants
2679801|NCT01408537|Secondary|Neutralizing Antibody Persistence One Year After the Primary Vaccination|To determine the neutralizing antibody persistence one year after the primary JEVAC vaccination.|1 year after primary vaccination|The analysis was excluded 5 subjects who had NT titer >10 on D0|||participants|||Number
2679802|NCT01408537|Secondary|Adverse Events of Vaccine|To determine the adverse events of JEVAC|7, 14, 28 days after each vaccination and throughout the study period for local, solicited systemic, unsolicited systemic and serious adverse events, respectively|Determined AEs by number of injections 152 injection for the first dose 151 injection for the second dose 145 injection for the third dose|||events|Participants||Number
2679803|NCT01408537|Secondary|Geometric Mean Titer of NT After Primary and Booster Vaccination|To determine the geometric mean titers (GMT) of neutralizing antibody of JEVAC 1 month after primary and then before and after booster vaccinations.|28 days after second vaccination, before and 28 days after booster vaccination with JEVAC|152 were enrolled, 1 withdrawn consent before second vaccine, 5 had NT >= 10 before first vaccine, 146 included in D28 after second vaccine. At 1 year, 3 received JE vaccine outside the study, 3 lost follow up, 140 included in before booster, At D28 after booster, 1 could not draw blood, 139 included in D28 after booster.|||titer||95% Confidence Interval|Geometric Mean
2679804|NCT01408537|Primary|Seroconversion Rate After Primary Vaccination|To determine the seroconversion rate by using neutralizing antibody (NT) against JE virus (Beijing P3 strain) JE virus from <10 on before first vaccination To >= 10 at 28 days after second vaccination (primary vaccination). Those who have NT titer >=10 before first vaccination, will not be included in immunogenicity evaluation.|28 days after second dose of JEVAC|There were 152 enrolled subjects in the study. However, 5 subjects had NT titer >= 10 before first vaccination and one subject whom blood on 28days after second vaccination was not drawn due to withdrawn consent. Therefore, the number of subjects for the outcome measurement should be 146.|||percentage of seroconversion|||Number
2679805|NCT01408485|Secondary|Secondary Efficacy|Secondary efficacy or chronic success is defined as freedom from recurrence of typical atrial flutter 3 mos. post ablation. Flutter recurrence will be documented on an ECG. Repeat ablations, new antiarrhythmia medications or increase in the existing anti-arrhythmic medications during the 3 mos. post ablation are considered chronic failures.|3 months||||participants|||Number
2679806|NCT01408485|Primary|Primary Efficacy|Primary efficacy or acute success is defined as achievement of bi-directional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system.|30 minutes||||participants|||Number
2679807|NCT01408485|Primary|Primary Safety: Incidence of Composite, Serious Adverse Events Within 7 Days Post-Procedure|Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.|7 days|200 subjects who met Inc/Excl criteria were enrolled. 21 subjects were withdrawn prior to the use of the investigational device, thus, 179 were treated. 5 subjects had composite adverse events that were serious and occurred within 7 days of the ablation procedure. These events are part of the primary safety endpoint analysis per protocol.|||participants|||Number
2679808|NCT01408329|Primary|Plasma Glucose Concentration||Glucose measurements were made at baseline, 3, 6, & 10 weeks. Blood was collected consistently after a 10-12 h fast the morning after a CVAC session (except for baseline).|Those that completed the study|||mg/dl||Standard Deviation|Mean
2679809|NCT01408303|Primary|Serum Non-HDL Cholesterol|The primary endpoints are the differences in mean percent changes from baseline to end-of-treatment in non-HDL cholesterol between placebo and the 2g/day and 4g/day Epanova groups.|6 weeks|"The Intent-to-Treat (ITT) Population was comprised of all subjects who were randomized. In the event that randomized subjects terminated before treatment or had no post-treatment efficacy assessments, a modified ITT Population was implemented."|||Percent change from baseline||95% Confidence Interval|Least Squares Mean
2679810|NCT01408277|Primary|Mean Percent Change in Wound Area|Wound area was measured using the ARANZ Silhouette digital wound imaging and measurement device. The average percent (%) of change from baseline of the target wound area at the end of the 6-week treatment period and the end of the entire 12-week study period respectively, was calculated using a two-way ANCOVA model.|6 and 12 weeks|Primary analysis was based on the Intent-to-treat dataset which consisted of all subjects randomized to treatment.|||percentage of change in wound area||Standard Error|Mean
2679812|NCT01408043|Secondary|Need for Remobilization|"Number of participants that needed remobilization in supermobilizers and normal mobilizers.~Remobilization can be described as follows:~The first step for patients undergoing autologous hematopoietic cell transplantation is to mobilize hematopoietic progenitor/stem cells from the bone marrow using G-CSF, plerixafor and/or chemotherapy. This is followed by collection of the cells by apheresis. If sufficient number of progenitor/stem cells cannot be mobilized and then collected by apheresis to proceed with transplantation, it is considered as mobilization failure. For these patients, mobilization of their hematopoietic progenitor/stem cells is attempted a second time (remobilization). The need to do a second 'mobilization' attempt is not ideal."|Up to 28 days post treatment|Participants that were mobilized|||Participants|||Count of Participants
2679813|NCT01408043|Secondary|Number of Transfusion Requirements|Number of transfusions (number of packed red blood cells and platelet transfusions required from day 0 to +28 post-transplant) in supermobilizers and normal mobilizers|Up to 28 days post treatment|Participants that were mobilized|||transfusions||Standard Deviation|Mean
2679814|NCT01408043|Secondary|Number of Days of Apheresis Required|Number of days of apheresis required to achieve goal in supermobilizers and normal mobilizers|Up to 28 days post treatment|Participants that were mobilized|||days||Standard Deviation|Mean
2679815|NCT01408043|Secondary|Overall Survival in Supermobilizers and Normal Mobilizers|Percentage of participants who were alive 1 year after transplant (OS)|Up to 1 year post-transplant|All participants that had some mobilization|||percent of participants|||Number
2679816|NCT01408043|Secondary|Progression-free Survival in Supermobilizers and Normal Mobilizers|Percentage of participants who were alive and free of progression 1 year after transplant (PFS)|Up to 1 year post-transplant|All participants that had some mobilization|||percent of participants|||Number
2679817|NCT01408043|Secondary|Length of Hospital Stay in Super Mobilizers and Normal Mobilizers|Length of hospital stay in participants receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg.|Up to 28 days post treatment|All participants that had some mobilization|||days||Standard Deviation|Mean
2679818|NCT01408043|Secondary|Platelet Recovery in Super Mobilizers and Normal Mobilizers|Platelet recovery in participants receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg.|Up to 28 days post treatment|All participants that had some mobilization|||percentage of change||Standard Deviation|Mean
2679819|NCT01408043|Secondary|Neutrophil Recovery in Super Mobilizers and Normal Mobilizers|Neutrophil recovery in participants receiving greater than or equal to 8 and less than 8 x 10^6 CD34+ cells/kg entered as the mean cell count of super mobilizers and normal mobilizers.|Up to 28 days post treatment|All participants that had some mobilization|||K/ul||Standard Deviation|Mean
2679820|NCT01408043|Primary|Overall Survival|Number of participants who receive greater than or equal to 8 x 10^6 CD34+ cells/kg by 15% following collection with plerixafor, etoposide, and filgrastimstill alive at 1 yr post transplant|Up to 1 year post-transplant|Number of supermobilizer participants that were able to achieve collection of ≥ 8 x 106 CD34+ cells/kg|||Participants|||Count of Participants
2679821|NCT01408043|Primary|Progression-free Survival|The number of participants of patients who receive greater than or equal to 8 x 10^6 CD34+ cells/kg following collection with plerixafor, etoposide, and filgrastim and that have progression-free survival at one year|Up to 1 year post-transplant|Number of supermobilizer participants that were able to achieve collection of ≥ 8 x 106 CD34+ cells/kg|||Participants|||Count of Participants
2679822|NCT01408043|Primary|Collection Using Plerixafor, Etoposide, and Filgrastim|Number of participants able to collect equal to or more than 8 x 10^6 CD34+ cells/kg with addition of plerixafor to etoposide and filgrastim. These participants are defined as supermobilizers. Participants with less than 8 x 10^6 CD34+ cells/kg are defined as normal mobilizers.|Within 2 days of apheresis|All participants that went on study|||Participants|||Count of Participants
2679823|NCT01408030|Secondary|Number of Participants With Treatment Failure|Treatment failure is defined as the occurrence of one or more of the following during the study: need for nasal surgery or chemical cautery or other new treatment modality to control epistaxis; transfusion of more than 12 units of RBC; severe complications such as acute myocardial infarction, venous thromboembolism, brain hemorrhage; or death|Baseline through 12 weeks||||Participants|||Count of Participants
2679824|NCT01408030|Secondary|Number of Participants Requiring Red Blood Cell (RBC) Transfusion|Number of participants requiring RBC transfusion during weeks 1-12|12 weeks||||Participants|||Count of Participants
2679825|NCT01408030|Secondary|Hemoglobin Level|grams/100 ml, assessed at week 12|12 weeks|8 participants who finished the active treatment phase did not have a hemoglobin level measured, and thus only 99 were analyzed.|||gram/100 ml||Inter-Quartile Range|Median
2679826|NCT01408030|Secondary|Hoag Epistaxis Severity Score|Hoag Epistaxis Severity Score (ESS) is based on 6 nosebleed variables such as frequency and duration which are entered by patients. The ESS has a minimum value of 0 and maximum value of 10, with 10 representing more severe epistaxis.|12 weeks|Participants were included in this analysis if they completed week 12 (phase 1) and filled out an ESS score. 1 participant each from the bevacizumab and placebo group did not fill out an ESS score at week 12.|||units on a scale (0-10)||95% Confidence Interval|Median
2679827|NCT01408030|Secondary|Duration of Epistaxis|Total minutes of bleeding per week|5-12 weeks of active treatment|Participants were included in this analysis (112) if they had at least 3 weeks of data during weeks 5-12; therefore the number of participants analyzed do not equal the number who finished the active treatment phase (120). 2 patients were lost to follow up, 5 dropped out before week 5, and 1 had no epistaxis diary.|||Total minutes of bleeding per week||Inter-Quartile Range|Median
2679828|NCT01408030|Primary|Frequency of Epistaxis|Bleeding episodes per week|Weeks 5-12 of active treatment phase|Participants were included in this analysis (106) if they had at least 3 weeks of data during weeks 5-12; therefore the number of participants analyzed do not equal the number who finished the active treatment phase (120). 2 patients were lost to follow up, 5 dropped out before week 5, 6 filled out diaries incorrectly, and 1 had no diary.|||Bleeding episodes per week||Inter-Quartile Range|Median
2679857|NCT01407575|Primary|Blood Pressure|Measure of systolic and diastolic blood pressure. 140/90 or lower is considered normal and indicates a better outcome.|6 weeks||||mm Hg||Standard Deviation|Mean
2679858|NCT01407575|Primary|Montgomery Asberg Depression Rating Scale|measure of depression severity Theoretical Range 0-60 lower values represent better outcome|6 weeks||||units on a scale||Standard Deviation|Mean
2679829|NCT01407952|Secondary|Number of Participants Experiencing Major Versus Minor Recurrence by 24 Months Follow-up.|"Major recurrence is defined as progression on the Raymond-Roy (RR) Scale to 3, or if initial RR was 3, then progression on the Meyers scale. Minor recurrence was defined as a progression on the RR scale to 2.~The RR scale is a 3 point measure of occlusion, 1=total, 2=residual neck, and 3=residual aneurysm.~The Meyer scale is a 6-point grading scale based on the percentageof the aneurysm filled by contrast on DSA. Grade zero indicates complete and total aneurysm occlusion without remnant or in-terstitial filling within the aneurysm. Grade 1 represents >90%volumetric occlusion of the aneurysm based on planar imaging assessment; grade 2, 70%-89% aneurysm occlusion; grade 3,50%-69%; grade 4, 25%-49%; and grade 5, <25% volumetric aneurysm occlusion."|24 months||||Participants|||Count of Participants
2679830|NCT01407952|Secondary|Number of Participants Who Progressed on the Meyers Scale|Occlusion (in)stability was determined by progression on the Meyers scale. The Meyer scale is a 6-point grading scale based on the percentage of the aneurysm filled by contrast on DSA. Grade zero indicates complete and total aneurysm occlusion without remnant or in-terstitial filling within the aneurysm. Grade 1 represents greater than 90%volumetric occlusion of the aneurysm based on planar imaging assessment; grade 2, 70%-89% aneurysm occlusion; grade 3,50%-69%; grade 4, 25%-49%; and grade 5, less than 25% volumetric aneurysm occlusion.|24 months||||Participants|||Count of Participants
2679831|NCT01407952|Secondary|Number of Participants Experiencing a Hemorrhage From Target Aneurysm Post Surgery|Per the Adverse event log, if a hemorrhage or rupture occurred that was noted to be related to the procedure or device at any point during the 24 month follow-up (not during the operation).|24 months||||Participants|||Count of Participants
2679832|NCT01407952|Secondary|Number of Patients Who Needed Re-treatment of Target Aneurysm|During the 24 month follow-up, if Aneurysm needed to be re-treated.|24 months|participants with available followup|||Participants|||Count of Participants
2679833|NCT01407952|Secondary|Number of Participants With Initial Complete Occlusion|Raymond-Roy (RR) Scale=1 at procedure The RR scale is such that 1=complete occlusion, 2=residual neck, and 3=residual aneurysm.|at procedure|Raymond-Roy Scale recorded at procedure|||Participants|||Count of Participants
2679834|NCT01407952|Secondary|Number of Patients Who Expired During the Study (Mortality Rate)|all-cause mortality at any time during study follow-up|24 months||||Participants|||Count of Participants
2679835|NCT01407952|Secondary|Total Number of Peri-procedural and Post-procedural Adverse Events Related to the Procedure and/or the Device.|total number of Adverse Events per person that were noted to be related to the procedure and device during the study|24 months|Intent to treat population|||Participants|||Count of Participants
2679836|NCT01407952|Secondary|Number of Participants With Adverse Events Related to the Procedure and/or the Device by Participant at Any Time in the Study.|number of participants who experienced any peri-procedural or post-procedural Adverse Event noted to be related to the procedure or device.|24 months|Intent to treat population|||Participants|||Count of Participants
2679837|NCT01407952|Secondary|Clinical Outcome: Modified Rankin Scale (mRS)|modified rankin scale is a measure of neurological disability, which ranges from 0=no symptoms to 5=severe disability (6=dead).|24 months|Based on participants with any post procedural follow-up.|||Participants|||Count of Participants
2679838|NCT01407952|Secondary|Packing Density|Packing density as measured by volumetric filling of the aneurysm|at operation|Participants with both imaging data (to determine aneurysm size), and coil information (length, number, and type used)|||density as expressed as a percentage||Standard Deviation|Mean
2679839|NCT01407952|Primary|Number of Patients With Aneurysm Recurrence Post Surgery|Defined as any progression on the Raymond-Roy (RR) Aneurysm Occlusion Scale. The RR scale is such that 1=complete occlusion, 2=residual neck, and 3=residual aneurysm.|post surgery to 24 months||||participants|||Number
2679840|NCT01407926|Secondary|SF-12 Mental Health Index|The SF-12 is a multipurpose short form to measure health status. There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means the better the outcome.|Baseline and 12 months|12 months minus Baseline value|||units on a scale||95% Confidence Interval|Mean
2679841|NCT01407926|Secondary|SF-12 Role Limitation Emotional Index|The SF-12 is a multipurpose short form to measure health status. There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means the better the outcome.|Baseline and 12 months|12 months minus Baseline value|||units on a scale||95% Confidence Interval|Mean
2679842|NCT01407926|Secondary|SF-12 Social Functioning Index|The SF-12 is a multipurpose short form to measure health status. There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means the better the outcome.|Baseline and 12 months|12 months minus Baseline value|||units on a scale||95% Confidence Interval|Mean
2679843|NCT01407926|Secondary|SF-12 Vitality Index Score|The SF-12 is a multipurpose short form to measure health status. There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means the better the outcome.|Baseline and 12 months|12 months minus Baseline value|||units on a scale||95% Confidence Interval|Mean
2679844|NCT01407926|Secondary|SF-12 Mental Health Composite Index|The SF-12 is a multipurpose short form to measure health status. There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means the better the outcome.|Baseline and 12 months|12 months minus Baseline value|||units on a scale||95% Confidence Interval|Mean
2679845|NCT01407926|Secondary|SF-12 General Health Index|The SF-12 is a multipurpose short form to measure health status. There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means the better the outcome.|Baseline and 12 months|12 months minus Baseline value|||units on a scale||95% Confidence Interval|Mean
2679846|NCT01407926|Secondary|SF-12 Pain Index Score|The SF-12 is a multipurpose short form to measure health status. There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means the better the outcome.|Baseline and 12 months|12 months minus Baseline value|||units on a scale||95% Confidence Interval|Mean
2679847|NCT01407926|Secondary|SF-12 Role Limitation Physical Index|The SF-12 is a multipurpose short form to measure health status. There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means the better the outcome.|Baseline and 12 months|12 months minus Baseline value|||units on a scale||95% Confidence Interval|Mean
2679848|NCT01407926|Secondary|SF-12 Physical Functioning Index|The SF-12 is a multipurpose short form to measure health status. There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means the better the outcome.|Baseline and 12 months|12 months minus Baseline value|||units on a scale||95% Confidence Interval|Mean
2679849|NCT01407926|Secondary|SF-12 Physical Composite Index|The SF-12 is a multipurpose short form to measure health status. There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means a better outcome|12 months minus Baseline value||||units on a scale||95% Confidence Interval|Mean
2679850|NCT01407926|Secondary|Generalized Anxiety Disorder Screener|"The Generalised Anxiety Disorder Assessment (GAD-7) is a seven item instrument that is used to measure or assess the severity of generalised anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Response options include not at all, several days, more than half the days and nearly every day.~The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of not at all, several days, more than half the days, and nearly every day, respectively, and then adding together the scores for the seven questions.~GAD-7 total score for the seven items ranges from 0 to 21. Scores represent:~0-5 = Mild anxiety~6-10 = Moderate anxiety~11-15 = Moderately severe anxiety~15-21 = Severe anxiety~When used as a screening tool, further evaluation is recommended when the score is 10 or greater"|Baseline and 12 months|12 months minus Baseline value|||units on a scale||95% Confidence Interval|Mean
2679851|NCT01407926|Primary|Centre for Epidemiological Studies in Depression Scale|The CES-D consists of 20 items, which range from 0-60, with higher scores indicating greater severity of depressive symptoms. It has been used in prior randomized controlled trials by three of the study investigators that involved older home care clients with mood disorders and has a high degree of reliability, content, construct and criterion related validity, distinguishes between depressed and non-depressed people, and is a sensitive tool for measuring changes in depressive symptoms over time in psychiatric populations.|Baseline to 12 months|12 months minus baseline value|||units on a scale||95% Confidence Interval|Mean
2679852|NCT01407575|Primary|Weight|Participant weight|6 weeks||||lbs||Standard Deviation|Mean
2679853|NCT01407575|Primary|Heart Rate|Heart Rate (Beats per minute) 60-100 beats per minute is considered normal lower heart rate represent healthier outcome|6 weeks||||Beats per minute||Standard Deviation|Mean
2679854|NCT01407575|Secondary|Positive and Negative Affect Scale|"Positive Affect Score: Scores can range from 10 - 50, with higher scores representing higher levels of positive affect.~Negative Affect Score: Scores can range from 10 - 50, with lower scores representing lower levels of negative affect."|6 weeks|reduced sample size verified. This was secondary to administrative error.|||units on a scale||Standard Deviation|Mean
2679855|NCT01407575|Secondary|Brief Symptom Inventory -- Anxiety Subscale|measure of anxiety Lower numbers indicate better outcome Theoretical Range 0-2.4|6 weeks||||units on a scale||Standard Deviation|Mean
2679859|NCT01407523|Secondary|Partial (Type 1) Seizure Frequency Per Day Over the Evaluation Period|Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.|During the Evaluation Period (Day 1 to Day 4)|Full Analysis Set (FAS). The FAS consisted of all subjects in the Safety Set (SS) with evaluable seizure frequency data over the Evaluation Period. All 16 subjects in the SS are included in the FAS.|||Seizures per day||Inter-Quartile Range|Median
2679860|NCT01407523|Secondary|Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4|"Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4.~Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows:~Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg."|Day 4|Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2679861|NCT01407523|Secondary|Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1|"Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1.~Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows:~Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg."|Day 1|Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2679862|NCT01407523|Secondary|Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4|Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4.|Day 4|Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2679863|NCT01407523|Secondary|Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1|Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1.|Day 1|Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS.|||micrograms per milliliter (µg/mL)||Geometric Coefficient of Variation|Geometric Mean
2679864|NCT01407523|Primary|Incidence of Treatment Emergent Serious Adverse Events During the Entire Study Period (up to 32 Days)|A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, results in significant or persistent disability/incapacity, is a congenital anomaly/birth defect (including that occurring in a fetus), or is an important medical event that may jeopardize the subject or may require medical or surgical intervention.|During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18)|Safety Set (SS)|||participants|||Number
2679865|NCT01407523|Primary|Incidence of Treatment Emergent Adverse Events During the Entire Study Period (up to 32 Days)|An Adverse Event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18)|Safety Set (SS)|||participants|||Number
2679866|NCT01407367|Secondary|Number of Deaths Among Participants (All-cause)|determined until end of study.|at the end of study (up to 4.25 years, depending on participant enrollment date)||||participants|||Number
2679867|NCT01407367|Secondary|Number of Participants With End-stage Renal Disease (ESRD) Defined as Need for Renal Replacement Therapy (Dialysis or Transplant)|ESRD defined as the need for renal replacement therapy with either dialysis (hemodialysis or peritoneal) for 3 months or more; or renal transplantation up until the time of end of study.|at the end of study (up to 4.25 years, depending on participant enrollment date)||||participants|||Number
2679868|NCT01407367|Secondary|Change in Renal Function From Baseline|Renal function with estimated glomerular filtration rate (eGFR) based on serum creatinine measured annually until time of end of study.|at the end of study (up to 4.25 years, depending on participant enrollment date)||||ml/min per 1.73m^2 per month||Inter-Quartile Range|Median
2679869|NCT01407367|Secondary|Rate of All-cause Hospitalization|Hospitalizations (following enrollment); including length of stay and safety events during hospitalization until time of end of study.|at the end of study (up to 4.25 years, depending on participant enrollment date)||||events per patient-years|||Number
2679870|NCT01407367|Primary|The Discrete Incidence of Any of the Chronic Kidney Disease Patient Safety Indicators (CKD-PSIs) Endorsed by the Consensus Expert Panel|"The discrete incidence of any of the following CKD-PSIs endorsed by the consensus expert panel:~Class I events: Incidence of patient reported adverse events related to medical care or medicines incuding: Falling, Bleeding, Edema, Angioedema, Confusion or altered mental status, Rhabdomyolysis~Class II events: Incidence of adverse events detected at annual study visits such as: Hyperkalemia, Hypokalemia, Hypoglycemia, Hyperglycemia, Orthostatic Hypotension, Hypotension, Hypertension, Bradycardia~Class III events: Incidence of usage of medications or agents to be avoided in CKD and Incidence of improperly dosed medications in CKD"|at the end of study (up to 4.25 years, depending on participant enrollment date)|Safety events reported in this outcome measure are from 6 months prior to participant's annual in-center visits|||events per 100 patient-visits|||Number
2679871|NCT01407354|Secondary|Number of Movement Recorded by Activity Monitor (SAM)|SAM movements not just steps were gathered one time pre, crossover and post and worn on ankle for 5 days; percent change for each intervention|7 months||||number of movements||Standard Deviation|Mean
2679874|NCT01407276|Secondary|Number of Participants Experiencing an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.|From pre-dose to 14 days post-dose (Up to Day 15)|All participants that received a single 3 mg dose of omarigliptin.|||Participants|||Number
2679875|NCT01407276|Primary|Apparent Terminal Half-life (t1/2) of Omarigliptin|T1/2 is the time required for the maximum concentration of a drug in the plasma to decrease by 50%.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||hour||Standard Deviation|Mean
2679876|NCT01407276|Primary|Time to Maximum Concentration (Tmax) of Omarigliptin|Tmax is a measure of the time to reach the maximum drug plasma concentration post-dose.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||hour||Full Range|Median
2679877|NCT01407276|Primary|Cumulative Amount of Drug Excreted in Urine Over 48 Hours (Ae0-48h) of Omarigliptin|Ae0-48h is a measure of the cumulative amount of drug excreted in the urine for 48 hours post-dose. Ae0-48h was only determined for Panels A-F.|Up to 48 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||mg||95% Confidence Interval|Least Squares Mean
2679878|NCT01407276|Primary|Fraction of Dose Excreted Unchanged in Urine Through 48 Hours Post-dose (fe48h) of Omarigliptin|fe48h is expressed as percentage of omarigliptin not metabolized and excreted in urine. fe48h was only determined for Panels A-F.|Up to 48 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||Percentage of total dose||95% Confidence Interval|Geometric Mean
2679879|NCT01407276|Primary|Renal Clearance (CLr) of Omarigliptin|CLr is a calculation of the rate at which a drug is removed from the body via renal clearance pathways, expressed as volume (milliliters) per unit of time (minutes). CLr was only determined for Panels A-F.|Up to 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||mL/min||95% Confidence Interval|Geometric Mean
2679880|NCT01407276|Primary|Apparent Total Body Clearance (CL/F) of Omarigliptin|CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic, and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).|Up to 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||mL/min||95% Confidence Interval|Geometric Mean
2679881|NCT01407276|Primary|Apparent Volume of Distribution (Vd/F) of Omarigliptin|Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.|Up to 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||L||95% Confidence Interval|Geometric Mean
2679882|NCT01407276|Primary|Concentration at 168 Hours Post-dose (C168h) of Omarigliptin|C168h is a measure of the plasma drug concentration 168 hours post-dose.|168 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||nM||95% Confidence Interval|Geometric Mean
2679883|NCT01407276|Primary|Area Under the Concentration-time Curve From Time 0 to 168 Hours Post Dose (AUC0-168h) of Omarigliptin|AUC0-168h is a measure of the total amount of drug in the plasma from the dose to 168 hours after the dose.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, and 168 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||nM*hr||95% Confidence Interval|Geometric Mean
2679884|NCT01407276|Primary|Maximum Concentration (Cmax) of Omarigliptin|Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||nM||95% Confidence Interval|Geometric Mean
2679885|NCT01407276|Primary|Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) of Omarigliptin|AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.|Pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 (Panel G only), 96, 168, 240, and 336 hours post-dose|All participants that received a single 3 mg dose of omarigliptin.|||nM*hr||95% Confidence Interval|Geometric Mean
2679886|NCT01407094|Primary|Hamilton Rating Scale for Depression|"The Hamilton Rating Scale for depression is a measure of depressive severity (HAM-D17; HDRS)~Scores range from 0-52~Lower scores indicate less depressive symptomatology, and so are the more desirable."|Week 8|Note subjects in the efficacy trial were those that completed 8 weeks of treatment, 115 in the sertraline group, and 123 in the placebo group. SERT had 34 wash-outs, PBO had 27.|||units on a scale||Standard Deviation|Mean
2679887|NCT01407068|Secondary|Clinical Success by Joint Type|Clinical success is defined as a reduction in fixed flexion contracture to 5° or less 30 days after injection of AA4500.|30 days after injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.|||number of joints|Number of joints||Number
2679888|NCT01407068|Primary|Change in Total Range of Motion|The total range of motion is the sum of the range of motion measurements of the two treated joints. Range of motion is defined as difference between full flexion angle and full extension angle expressed in degrees.|30 days after last injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.|||degrees||Standard Deviation|Mean
2679889|NCT01407068|Secondary|Investigator Assessment of Improvement With Treatment|"At the Day 60 follow-up visit, the investigator will determine the degree of improvement in the severity of the subject's treated finger(s) compared with screening as follows:~Very Much Improved~Much improved~Minimally Improved~No Change~Minimally Worse~Much Worse~Very Much Worse"|60 days after last injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.|||participants|||Number
2679919|NCT01406860|Primary|Pain Scale (Numerical Rating Scale for Pain)|Numerical Rating Scale for Pain on a scale of 0-10 with 10 representing the worst pain|Change in pain scores at 60 minutes from baseline as measured on the Numerical Rating Scale for Pain (NRS)|Data were not collected||||||
2679890|NCT01407068|Secondary|Subject Satisfaction With Treatment|"At the Day 60 follow-up visit, each subject will be asked to rate his/her satisfaction with treatment as follows:~Very Satisfied~Quite Satisfied~Neither Satisfied nor Dissatisfied~Quite Dissatisfied~Very Dissatisfied"|60 days after last injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.|||participants|||Number
2679891|NCT01407068|Primary|Percent Change From Baseline in Total Fixed Flexion|Total fixed flexion is defined as the sum of the fixed flexion contractures of the two joints receiving treatment. Change in fixed-flexion contracture is measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees|30 days after last injection|Efficacy analysis is based of the intent-to-treat population (ITT). The population is defined as all enrolled subjects who received two injections of AA4500 and had at least one-post-injection measurement.|||percentage of contracture change||Standard Deviation|Mean
2679892|NCT01406990|Primary|Women With Known CAD Who Are Hyporesponsive to Low Dose (81 mg) Aspirin|Hyporesponsive was defined as Aspirin Response Unit (ARU) > 550 equating to less than 50% platelet inhibition.|Time of enrollment||||participants|||Number
2679893|NCT01406938|Secondary|Number of Participants Developing Anti-secukinumab Antibodies|The development of anti-secunimubab anti-bodies will decrease a participant's ability to respond to secukinumab treatment. The number of participants developing anti-secukinumab anti-bodies was measured from Baseline to week 12, 24, 52 and 8 weeks after treatment at week 60|Baseline, weeks 12, 24, 52 and 60|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Number of participants|||Number
2679894|NCT01406938|Secondary|Number of Secukinumab Injections Needed to Regain PASI 75 Response From Start of Relapse After Week 12|The number of secukinumab injections needed for participants to regain PASI 75 response from the start of relapse after week 12|week 16, 20, 24,28,32,36,40,44,48,and Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||percent of participants|||Number
2679895|NCT01406938|Secondary|Number of Visits With PASI 50, 75, 90, 100 Score and IGA Mod 2011 0 or 1|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 16, 20, 24,28,32,36,40,44,48,and Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percent of participants|||Number
2679896|NCT01406938|Secondary|Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned, only participants with evaluable data were included|||Percent of participants|||Number
2679897|NCT01406938|Secondary|Percent of Responders With PASI Equal to or Greater Than 50, PASI 75, PASI 90, PASI 100 and Percent of Responders With IGA Score of 0 or 1 Who Failed to Respond to a Previous Biologic Psoriasis Therapy|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 12|Full analysis set (FAS) - All patients to whom study treatment was assigned, only participants with evaluable data were included|||Percent of participants|||Number
2679898|NCT01406938|Secondary|Median Time to Relapse (Weeks) From Week 12.|Median time to relapse (weeks) from week 12. Relapse is defined as greater than 50% loss of the maximal PASI improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement|Week 12 to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Number of weeks||95% Confidence Interval|Median
2679978|NCT01405898|Primary|Difference in Change in Clinic Diastolic Blood Pressure From Baseline||4 weeks||||mmHg||Standard Deviation|Mean
2679899|NCT01406938|Secondary|% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Maintenance).|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percent of participant|||Number
2679900|NCT01406938|Secondary|% of Participants Achieving a DLQI Score of 0 or 1 at Each Visit up to Week 52, (Induction)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Baseline to week 2, 4, 6, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percent of participants|||Number
2679901|NCT01406938|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Maintenance)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
2679902|NCT01406938|Secondary|Change From Baseline in Dermatology Life Quality Index (DLQI) Score. up to Week 52, (Induction)|"The DLQI is a quality of life measure used in the psoriatic The 10-item questionnaire has a score range of 0 (best) to 30 (worst) with higher scores indicating poor quality of life. The instrument contains six functional scales (i.e., symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment). Each item has 4 response categories, ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions"|Baseline to week 2, 4, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
2679903|NCT01406938|Secondary|Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Maintenance)|"ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example confined to bed) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)"|Baseline to week 16, 20, 24, 28, 32, 36, 40, 44, 48, and Week 52.|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
2679904|NCT01406938|Secondary|Change From Baseline in EQ-5D at Each Visit, up to Week 52, (Induction)|"ED-5Q: Participant rated questionnaire to assess health related quality of life in terms of a single utility score. Five domains are assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with three possible score: 1 indicates no problems, better state of health; 3 indicates worst state of health (example confined to bed) A visual analog scale (VAS) assesses the health status from 0 (worst possible health state) to 100 (best possible health state)"|Baseline to week 2, 4, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
2679905|NCT01406938|Secondary|Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Maintenance Period))|The IGA mod 2011 is a static scale, i.e., it refers exclusively to the participant's disease state at the time of the assessments and does not attempt a comparison to any of the participant's previous disease states at prior visits. The score ranges from 0 (clear) to 4 (severe. The score 0 is clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 is severe|Baseline, week 16,20,24,28,32,36,40,44,48, and Week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percent of participants|||Number
2679906|NCT01406938|Secondary|Percent of Participants Achieving Psoriasis Area & Severity Index (PASI) Score and IGA Mod 2011 0 or 1 Score Over Time at Week 12 and 52 (Induction)|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe|Baseline, week 2, 4, 6, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Percent of participant|||Number
2679907|NCT01406938|Secondary|Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week at Week 16, 20, 24,28,32,36,40,44,48,and Week 52|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)|Baseline, week 12,16,20,24,28,32,36,40,44,48 and week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
2679908|NCT01406938|Secondary|Absolute Change From Baseline for PASI 50 / 75 / 90 / 100 and IGA 2011 Score of 0 or 1 at Week 2, 4, 6, 8, 12|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head:01, arms:0.2 body:0.3 legs:0.4)|Baseline, week 2, 3 , 4, 8, 12|Full analysis set (FAS) - All patients to whom study treatment was assigned|||Units on a scale||Standard Deviation|Mean
2679909|NCT01406938|Primary|For the Fixed Interval Group and the Start of Relapse (SoR) Group, the Percentage of Participants (Who Responded to Treatment at Week 12) Maintaining a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 52|PASI: Combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section(head: 0.1, arms: 0.2 body: 0.3 legs: 0.4)|Week 40 , week 52|Full analysis set (FAS) - All patients to whom study treatment was assigned.|||Percent of participants|||Number
2679910|NCT01406873|Secondary|Mean Change From Baseline in Patient-Reported Disease Burden and Quality of Life|"The Myotonic Dystrophy Health Index (MDHI) is a validated disease-specific measure of patient-reported disease burden. The MDHI total score is a weighted average derived from 17 subscales. MDHI total scores range form 0-100 with 0 representing no patient-reported disease burden and 100 representing the most severe patient-reported disease burden.~The Individualized Neuromuscular Quality of Life Questionnaire (INQoL) is a measure of quality of life in neuromuscular disease. The INQoL summary score is a weighted average made up of 5 sub-domains. Scores range from 0-100, and can be interpreted as the percent of maximal detrimental impact on quality of life with higher scores indicating more detrimental impact.~The 36-Item Short Form Survey (SF-36) is a generic measure of quality of life across 8 domains. Two summary metrics are produced from the 8 domains, ranging from 0-100% with lower scores representing worse levels of functioning."|Baseline to 6 months|Intent to treat (ITT) population was defined as all participants who were randomized to the study, received at least one dose of study medication and have post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2679911|NCT01406873|Secondary|Mean Change From Baseline in PR, QRS, and QTc Intervals, and Average Minimum Heart Rate (HR) Via Electrocardiogram (ECG) Monitoring|PR, QRS, and QTc intervals as well as average minimum heart rate (HR) were obtained through standard 12 lead electrocardiograms (ECGs). Values were computer generated and verified by the study investigator and study cardiologist.|Baseline to 6 Months|Intent to Treat (ITT) population was defined as all participants who were randomized to the study, received at least one dose of study medication and have post-baseline efficacy assessment.|||Milliseconds||Standard Error|Mean
2679912|NCT01406873|Secondary|Mean Change From Baseline in Manual Muscle Testing (MMT) Score|Manual muscle testing was performed on 26 muscle groups (shoulder abductors, elbow flexors, wrist flexors, wrist extensors, hip flexors, knee extensors, hip extensors, knee flexors, hip abductors, elbow extensors, ankle dorsiflexors, and plantar flexors on the right and left plus neck extensor and neck flexors). The muscles were tested in various positions including sitting, supine, prone, and side lying and each graded on a modification of the Medical Research Council (MRC) scale of 0 to 5 (5 representing normal strength). Average MMT score is derived by averaging the individual MMT scores across the 26 individual muscles.|Baseline to 6 months|Intent to Treat (ITT) population was defined as all participants who were randomized to the study, received at least one dose of study medication and have post-baseline efficacy assessment.|||Units on a scale||Standard Deviation|Mean
2679913|NCT01406873|Secondary|Mean Change From Baseline in Quantitative Measure of Hand Grip Myotonia|Relaxation time of the long finger flexor muscles of the right hand after a maximum voluntary isometric contraction performed in a standardized fixed position of the right arm elbow/wrist/hand. Relaxation time for this measurement is defined as the time to relax from 90% to 5% of the maximum isometric force of contraction of the hand (the first of 6 serial contractions averaged over two consecutive trials performed 10 minutes apart).|Baseline to 6 months|Intent to Treat (ITT) population was defined as all participants who were randomized to the study, received at least one dose of study medication, and have post-baseline efficacy assessment at 6 months. Data was not analyzable on 3 people in the placebo arm.|||Seconds||Standard Deviation|Mean
2679914|NCT01406873|Secondary|Percentage of Participants That Had a Dose Reduction or a Study Drug Withdrawal or Suspension Over 6 Months|Adverse events were monitored at the three in-person evaluations (Months 0, 3, and 6), at telephone evaluations every 2 weeks, and via patient-completed side effect diaries. The study investigators and safety monitoring committee reviewed adverse events and made decisions regarding drug withdrawals, suspensions, and dose reductions as needed.|6 months|Intent to Treat (ITT) population was defined as all participants who were randomized to the study, received at least one dose of study medication and have post-baseline efficacy assessment.|||Participants|||Count of Participants
2679915|NCT01406873|Primary|Mean Change From Baseline in Ambulation Using the 6 Minute Walk Distance|During this assessment, participants were asked to walk as far as they could back and forth on a fixed 20 meter route for 6 minutes. The total distance walked during the 6 minutes was recorded in meters. Change from baseline was defined as the difference between the average 6 minute walk distance at baseline and the average 6 minute walk distance at 6 months.|Baseline to 6 months|Intent to Treat (ITT) population was defined as all participants who were randomized to the study, received at least one dose of study medication and have post-baseline efficacy assessment. Follow-up data was not collected on one participant in the mexiletine arm due to a broken foot.|||Meters||Standard Deviation|Mean
2679916|NCT01406860|Secondary|Adverse Effects|Frequency of adverse effects in each arm|From the time when the treatment is initiated until the 24 hour follow-up phone survey|Data were not collected||||||
2679917|NCT01406860|Secondary|24 Hour Pain Score|24 hour pain score (follow-up phone call)|24 hours after discharge from ED|Data were not collected||||||
2686921|NCT01346397|Primary|Graft Survival|in cyclosporine group 84.6 +/- 5.8%; in tacrolimus group 86.2 +/- 4.1%|5 years||||percentage of participants||95% Confidence Interval|Number
2679920|NCT01406795|Secondary|Villalta PTS Scale|The Villalta PTS Scale is a score based on the patient's symptoms, includes cramps, pain, and redness. It is scaled from 0 to 48, with a higher score representing more severe disease.|up to 2 years|Data were not collected for this outcome.||||||
2679921|NCT01406795|Secondary|VEINS-QOL|The VEINS-QOL is a questionnaire that represents a patient's quality of life, using measures like how well the patient can walk, sleep, and enjoy life. Responses are graded on a scale of 1-5, with 1 being very good, and 5 being very poor. The VEINS-QOL measure is defined by the count of participants that showed a decreased overall score following their procedure.|Up to 2 years||||Participants|||Count of Participants
2679922|NCT01406795|Secondary|Venous Clinical Severity Score|Venous Clinical Severity represents the severity of the venous pathology, which includes measures like pain, inflammation, and number of ulcers. It is scored on a scale of 0-3 with the upper end representing very severe outcomes for the patient.|up to 2 years|Data were not collected for this outcome||||||
2679923|NCT01406795|Secondary|Decrease in Swelling of Affected Extremity|The count of participants that experienced a decrease in swelling after the stent was placed.|up to 2 years||||Participants|||Count of Participants
2679924|NCT01406795|Secondary|Adverse Events|Adverse events were reported as the count of participants that experienced an adverse event within two years of their procedure.|up to two years 2 years||||Participants|||Count of Participants
2679925|NCT01406795|Secondary|Secondary Patency|Secondary patency means that the initial intervention failed and a second intervention was performed to establish or maintain patency. Secondary patency is defined as the count of participants that required a second intervention to establish patency.|up to 1 year||||Participants|||Count of Participants
2679926|NCT01406795|Secondary|Assisted-primary Patency|Patency refers to whether the stent is unoccluded (open). Primary refers to the first time a stent was placed (or the first time patency needed to be established). Assisted refers to the fact that a device (like a balloon) was used to open the stent. Assisted-primary patency is defined as the count of participants that demonstrated the need for an intervention to establish patency.|up to 1 year||||Participants|||Count of Participants
2679927|NCT01406795|Secondary|Freedom From Device-related Amputation|Freedom from device-related amputation (amputation of infected limb) is reported as the count of participants with no device-related amputation within 1 year following stent placement.|up to 1 year following the procedure||||Participants|||Count of Participants
2679928|NCT01406795|Primary|Primary Patency Rate|Patency refers to whether the stent is unoccluded (open). Primary patency rate was defined as the count of participants with >= 50% patency following initial stent placement, and is reported as the count of participants meeting this criteria.|up to 1 year following the procedure||||Participants|||Count of Participants
2679929|NCT01406795|Primary|Stent Migration|Stent migration is reported as the count of participants with stent migration within 1 year following stent placement.|up to one year following the procedure 1 year||||Participants|||Count of Participants
2679930|NCT01406795|Primary|Stent Migration|Stent migration is reported as the count of participants with stent migration within 1 month following stent placement.|up to 1 month following the procedure||||Participants|||Count of Participants
2679931|NCT01406717|Secondary|Change From Baseline in Total Cholesterol||24 weeks||||mg/dL||Standard Error|Least Squares Mean
2679932|NCT01406717|Secondary|Change From Baseline in Very Low Density Lipoproteins||24 weeks||||mg/dL||Standard Error|Least Squares Mean
2679933|NCT01406717|Secondary|Subjects Achieving HbA1c < 7%||24 weeks|Evaluable Population for Efficacy|||Participants|||Count of Participants
2679934|NCT01406717|Secondary|Change in Body Weight||24 weeks||||kilograms||Standard Error|Least Squares Mean
2679935|NCT01406717|Secondary|Change From Baseline in High Density Lipoproteins||24 weeks||||mg/dL||Standard Error|Least Squares Mean
2679936|NCT01406717|Secondary|Change From Baseline in Low Density Lipoproteins||24 weeks||||mg/dL||Standard Error|Least Squares Mean
2679937|NCT01406717|Secondary|Change From Baseline in Triglycerides||24 weeks|The evaluable population: all mITT subjects who received at least 80% of study medication over 24 weeks and completed treatment through week 24. (modified Intent-to-treat population: .subjects who were randomized and received at least one dose of the trial medication after visit 2 (baseline) and had at least one post-baseline visit.|||mg/dl||Standard Error|Least Squares Mean
2679938|NCT01406717|Secondary|Change From Baseline in 2-h PPG||24 weeks|The evaluable population: all mITT subjects who received at least 80% of study medication over 24 weeks and completed treatment through week 24. (modified Intent-to-treat population: .subjects who were randomized and received at least one dose of the trial medication after visit 2 (baseline) and had at least one post-baseline visit.|||mg/dl||Standard Deviation|Mean
2679939|NCT01406717|Primary|Proportion of Subjects With Potentially Immune-related TEAEs||24 weeks|Evaluable population for safety: subjects who were randomized and received at least one dose of a trial medication|||Participants|||Count of Participants
2679940|NCT01406717|Primary|Proportion of Subjects Positive for Anti-exenatide Antibodies||24 weeks|modified intent to treat population|||Participants|||Count of Participants
2679941|NCT01406717|Primary|Change From Baseline to End of Study in FPG||24 weeks||||mg/dL||Standard Error|Least Squares Mean
2679942|NCT01406717|Primary|Change From Baseline to End of Study in HbA1c||24 weeks|Intent-to-treat|||percentage of HbA1c||Standard Error|Least Squares Mean
2679943|NCT01406652|Secondary|Number of Participants With Post-surgical Wound Dehiscence|We assess clinical failures of bursectomy for bursitis. As recurrences are associated with wound dehiscence, we evaluate the dehiscence a the most important parameter for Failure. Of course, dehiscence can also occur without recurrent infection, but this is also considered as failure.|2 months||||participants|||Number
2679944|NCT01406652|Primary|Overall Costs of the Combined Surgical and Medical Treatment|The overall costs are of primary interest in the study protocol.|2 months|The overall costs (Swiss francs; CHF) are of primary interest in the study protocol|||Swiss Francs||Inter-Quartile Range|Median
2679945|NCT01406574|Secondary|Best Overall Response|Overall response was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST guideline) - mRECIST 1.0.|From first dose of study medication up to 28 weeks|"Efficacy population included all treated subjects who had received at least 1 dose of study drug.~No statistical analysis provided for Best Overall Responders."|||participants|||Number
2679946|NCT01406574|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|"Recommended Dose (RD) of OPB-31121 was defined as the highest dose at which Dose Limited Toxicity (DLT) occurred at an incidence of < 30%.~DLT was defined as adverse events related to OPB-31121 occurring until Day 32, and 1) Grade 4 neutrophil count decreased persisting for ≧ 8 days, or Grade 3 or 4 febrile neutropenia, or infection with neutrophil count decreased 2) Grade 4 Plt decreased, or Grade 3 Plt decreased persisting for ≧ 8 days 3) Grade 3 or 4 nausea, vomiting, or diarrhoea that occurred despite the use of an anti-emetic or anti-diarrheal agents 4) Grade 3 or more severe AEsa excluding the AEs presented above 1) to 3) 5) AEs requiring interruption of IMP administration for a period of ≧ 8 consecutive days 6) Same AEs causing interruption of IMP administration twice"|From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)|"DLT evaluated subjects who had achieved ≧75% study drug compliance during a 4-week (28-day) treatment period starting from Day 4.~No statistical analysis provided for Subjects With DLTs."|||participants|||Number
2679947|NCT01406574|Primary|Subjects With Treatment Emergent Adverse Events|Treatment emergent adverse events observed during outcome measure time frame.|From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)|Safety population No statistical analysis provided for Subjects With Treatment Emergent Adverse Events.|||participants|||Number
2679948|NCT01406223|Secondary|Days to First Cigarette Following Quitting Smoking|Days to first cigarette (i.e. lapse) will be measured via self-report.|Up to 11 weeks post quit day.|Twenty-eight subjects dropped from the study prior to their scheduled quit day, so they were not included in these analyses.|||days||Standard Deviation|Mean
2679949|NCT01406223|Primary|The Amygdala, Anterior Insula, and Medial Prefrontal Cortex Scans Will be Compared to Evaluate Significant Differences|Mean blood-oxygen-level dependent (BOLD) contrast sensitive functional magnetic resonance imaging (fMRI) cue-reactivity signal following 2 week pre-quit treatment, controlling for baseline cue-reactivity.|change from baseline in whole brain blood-oxygen-level dependent (BOLD) contrast sensitive functional magnetic resonance imaging (fMRI) images collected during a cue-reactivity task following 2 weeks of pre-quit treatment|Only participants who completed both scanning sessions and provided useable data were included in imaging analysis.|||percent BOLD signal change||Standard Deviation|Mean
2679950|NCT01406015|Secondary|Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)|Insulin resistance was measured using the 75 G glucose tolerance test. Participants ingested 75 grams of glucose in 300-400 mL of water over 5 minutes. Blood samples were taken before ingesting glucose and then every 30 minutes for 120 minutes. HOMA-IR was calculated using the Insulin and glucose levels obtained. A negative change (decrease in insulin resistance) indicates improvement.|Baseline and Week 6 (Prior to ingesting glucose and every 30 minutes for 120 minutes)|All randomized participants who completed the study.|||IR index||Standard Deviation|Mean
2679951|NCT01406015|Secondary|Change From Baseline in Insulin Sensitivity Index (ISI)|Insulin sensitivity was measured using the 75 gram (G) glucose tolerance test. Participants ingested 75 grams of glucose in 300-400 milliliters (mL) of water over 5 minutes. Blood samples were taken before ingesting glucose and then every 30 minutes for 120 minutes. Insulin sensitivity index was calculated by Matsuda and Defronzo's formula using the values obtained. A positive change from Baseline (increase in insulin sensitivity) indicates improvement.|Baseline and Week 6 (Prior to ingesting glucose and every 30 minutes for 120 minutes)|All randomized participants who completed the study.|||IS index||Standard Deviation|Mean
2679952|NCT01406015|Secondary|Change From Baseline in Markers of Inflammation|Blood was to be collected and tested for Tumor Necrosis Factor Alpha (TNF-α) and Monocyte Chemotactic Protein-1 (MCP-1), markers of inflammation; However, due to lack of funding, blood samples were not analyzed and data for levels of inflammation markers were not collected.|Baseline and Week 6|Analysis was not performed.||||||
2679953|NCT01406015|Secondary|Change From Baseline in Para-aminohippurate (PAH) Clearance|Renal plasma blood flow was determined by clearance of para-aminohippurate (PAH). A loading dose of PAH (8 mg/kg) was given intravenously followed by a 1 hour constant infusion of PAH at a rate of 12 mg/minute (min). Plasma samples were obtained at Baseline and at 50 and 60 minutes. PAH clearance was calculated from the plasma levels and infusion rates and reported in millimeters (mL)/minute (min). A positive change from Baseline indicates improvement.|Baseline and Week 6 (Prior to PAH infusion and at 50 and 60 minutes post PAH infusion)|All randomized participants who completed the study.|||mL/min||Standard Deviation|Mean
2679954|NCT01406015|Primary|Change From Baseline in Post-ischemic Dilatation|Ultrasonography of the brachial artery was performed to evaluate endothelial function by flow mediated dilatation (FMD) studies. A blood pressure cuff was placed on the participant's upper arm and was compressed for 5 minutes. After release of compression, brachial artery diameter and blood flow velocity were measured. FMD was expressed as the percentage change in brachial artery diameter. A positive change from Baseline indicates improvement.|Baseline and Week 6|All randomized participants who completed the study.|||percent dilalation||Standard Deviation|Mean
2679955|NCT01405950|Secondary|Pharmacokinetic (PK) Parameter Cmax (Maximum Observed Drug Concentration in Plasma) of a Single Dose of Tizanidine at 4 Different Dose Levels in Children and Adolescents With Cerebral Palsy and Mild to Moderate Spasticity.|"Baseline: immediately before the standardized meal (i.e., before administration of tizanidine) on dosing day~0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after administration of tizanidine~PK parameters will be derived by using WinNonlin Pro (version 5.0.1 or later, Pharsight Corp)."|Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours|Pharmacokinetics Population|||nanogram/mililiter||Standard Error|Mean
2679956|NCT01405950|Primary|Pharmacokinetic (PK) Parameter AUC0-8 (Area Under the Concentration-time Curve From Time 0 to 8 Hours) of a Single Dose of Tizanidine at 4 Different Dose Levels in Children and Adolescents With Cerebral Palsy and Mild to Moderate Spasticity.|"Baseline: immediately before the standardized meal (i.e., before administration of tizanidine) on dosing day~0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after administration of tizanidine~PK parameters will be derived by using WinNonlin Pro (version 5.0.1 or later, Pharsight Corp)."|Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours|Pharmacokinetics Population|||hour*nanogram/mililiter||Standard Error|Mean
2679979|NCT01405898|Secondary|Difference in Change in Endothelial Function From Baseline|as measured by flow-mediated dilatation [%change in diameter of vessel] - an increase in diameter demonstrates an improvement in endothelial function|4 weeks||||% dilatation||Standard Deviation|Mean
2679980|NCT01405898|Secondary|Difference in Change in Plasma Nitrite Concentration From Baseline||4 weeks||||umol/L||Standard Deviation|Mean
2679957|NCT01405937|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment|||percentage of participants|||Number
2679958|NCT01405937|Secondary|Mean Change From Baseline in HCV RNA (Log 10)|"HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered undetectable."|Baseline, Week 2, Week 4, Week 8, Week 12, Week 24|Participants in the FAS population (all randomized participants who received at least one dose of study treatment) that had HCV RNA data available.|||Log IU/ml||Standard Deviation|Mean
2679959|NCT01405937|Primary|Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE. For this study, safety parameters or AEs of special interest that were identified a priori included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal (GI) adverse experiences (vomiting, nausea, and diarrhea). The percentage of participants with ≥1 specific AEs were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment|||percentage of participants||95% Confidence Interval|Number
2679960|NCT01405937|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)|Participants were assessed for undetectable HCV RNA levels at the end of all study therapy. The percentage of participants with undetectable HCV RNA levels at EOT were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 24|FAS population; all randomized participants who received at least one dose of study treatment.|||Percentage of participants||95% Confidence Interval|Number
2679961|NCT01405937|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR)|cEVR was defined as having an undetectable HCV RNA level at Week 12. The percentage of participants achieving cEVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 12|FAS population; all randomized participants who received at least one dose of study treatment.|||Percentage of participants||95% Confidence Interval|Number
2679962|NCT01405937|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR)|RVR was defined as having an undetectable HCV RNA level at Week 4. The percentage of participants achieving RVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 4|FAS population; all randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2679963|NCT01405937|Secondary|Percentage of Participants Achieving SVR12|SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy. The percentage of participants achieving SVR12 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|12 weeks after 24 weeks of study therapy (up to 36 weeks)|FAS population; all randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2679964|NCT01405937|Primary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)|SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy. The percentage of participants achieving SVR24 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|24 weeks after 24 weeks of study therapy (up to 48 weeks)|Full Analysis Set (FAS) population; all randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2679965|NCT01405924|Secondary|Percentage of Participants Who Used No Rescue Medication During Cycle 2 of Chemotherapy|Participants recorded any use of rescue medication for established nausea/vomiting in their daily diaries from initiation of chemotherapy infusion through the morning of Day 6. The percentage of participants who used no rescue medication during Cycle 2 of chemotherapy was calculated.|Up to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.|||Percentage of Participants|||Number
2679966|NCT01405924|Secondary|Percentage of Participants With No Significant Nausea During Cycle 2 of Chemotherapy|"Participants rated their degree of nausea in response to How much nausea have you had over the last 24 hours? using a 100-mm visual analog scale (VAS, 0=no nausea, 100=nausea as bad as it could be) on Days 2-6 following initiation of chemotherapy. No significant nausea was defined as VAS score <25 mm over the 24-120 hours following initiation of chemotherapy. The percentage of participants who experienced no significant nausea during Cycle 2 of chemotherapy was calculated."|From 24 to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.|||Percentage of Participants|||Number
2679981|NCT01405898|Primary|Difference in Change in Clinic Systolic Blood Pressure From Baseline||4 weeks||||mmHg||Standard Deviation|Mean
2680172|NCT01404234|Secondary|Change in Pseudomonas Aeruginosa (PA) Sputum Density|The change in PA sputum density (log10 colony-forming units per gram [cfu/g]) was assessed at the end of each 28-day AZLI treatment course.|Baseline to Day 28, 84, and 140|Participants in the Full Analysis Set ≥ 6 years of age were analyzed.|||log10 CFU/g||Standard Deviation|Mean
2679967|NCT01405924|Secondary|Functional Living Index - Emesis (FLIE) Total Score During Cycle 2 of Chemotherapy|"The FLIE Total Score is an 18-question quality-of-life questionnaire on the impact of nausea and vomiting (9 questions on nausea and 9 questions on vomiting) on daily life. Each question uses a visual analog scale (VAS) to rate the impact of nausea/vomiting from 1 to 7. FLIE Total Scores are calculated by summing the responses to the 18 questions and can range from 18-126 (18=a great deal of impairment, 126=no impairment), with a higher score indicating less impairment due to nausea and vomiting. No Impact on daily life was defined as a FLIE Total Score >108. Participants completed the FLIE questionnaire on the morning of Day 6 following initiation of chemotherapy in Cycle 2; their responses covered their experiences with nausea and vomiting over the previous 5 days."|From Day 1 (prior to initiation of chemotherapy in Cycle 2) to morning of Day 6 (up to ~120 hours following initiation of chemotherapy in Cycle 2)|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.|||Score on a Scale||Standard Deviation|Mean
2679968|NCT01405924|Secondary|Percentage of Participants With a Complete Response During Cycle 2 of Chemotherapy|A complete response is defined as no vomiting/no retching episodes and no use of rescue medication during the 120 hours following initiation of chemotherapy. The percentage of participants with a complete response during Cycle 2 of chemotherapy was calculated.|Up to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.|||Percentage of Participants|||Number
2679969|NCT01405924|Secondary|Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy Per Type of Chemotherapy|A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of partcipants with no vomiting and no retching episodes 0-120 hours following initiation of chemotherapy in Cycle 2 was calculated based on type of chemotherapy received.|Up to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data. Participants were grouped into 2 cohorts based on type of chemotherapy received.|||Percentage of Participants|||Number
2679970|NCT01405924|Primary|Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy|A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of partcipants with no vomiting and no retching episodes 0-120 hours following chemotherapy in Cycle 2 was calculated.|Up to 120 hours following initiation of chemotherapy in Cycle 2|The population consisted of all participants who received chemotherapy, received a dose of study drug, had no protocol deviations and had complete data.|||Percentage of Participants|||Number
2679971|NCT01405911|Primary|Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE)|An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Up to 8 weeks|All randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the actual study treatment they received. Due to a prescription error, one participant who was randomized to the placebo group took sitagliptin 50 mg.|||Percentage of participants|||Number
2679972|NCT01405911|Primary|Percentage of Participants Who Experienced One or More Adverse Events (AEs)|An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Up to 10 weeks|All randomized participants who received at least one dose of study treatment. Participants were included in the treatment group corresponding to the actual study treatment they received. Due to a prescription error, one participant who was randomized to the placebo group took sitagliptin 50 mg.|||Percentage of participants|||Number
2679973|NCT01405911|Secondary|Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for 75-gram Oral Glucose Tolerance Test (OGTT) at Week 7|Glucose total AUC 0-2 hours for 75 g OGTT was measured at Baseline (Week -1) and at Week 7. After fasting for ≥10 hours, blood samples for glucose measurement were drawn at 0 minutes (at 75 g glucose loading), 30 minutes, 60 minutes, 90 minutes, and 120 minutes. At Week 7, participants received study drug or placebo 30 minutes prior to loading 75 g glucose solution.|Baseline (Week -1) and Week 7|All participants, as randomized, who received at least one dose of study treatment and have a baseline measurement or post-randomization measurement for the analysis endpoint subsequent to study treatment.|||Percent change||95% Confidence Interval|Least Squares Mean
2679974|NCT01405911|Primary|Percent Change From Baseline in Glucose Total Area Under the Concentration Curve 0 to 2 Hours (AUC 0-2 Hrs) for Meal Tolerance Test (MTT) at Week 8|Glucose total AUC 0-2 hours for MTT was measured at Baseline (Week 0) and at Week 8. After fasting for ≥10 hours, blood samples for glucose measurement were drawn at 0 minutes (at standard meal loading), 30 minutes, 60 minutes, 90 minutes, and 120 minutes. At Week 8, participants received study drug or placebo 30 minutes prior to consuming a standard meal.|Baseline (Week 0) and Week 8|All participants, as randomized, who received at least one dose of study treatment and have a baseline measurement or post-randomization measurement for the analysis endpoint subsequent to study treatment.|||Percent change||95% Confidence Interval|Least Squares Mean
2679975|NCT01405898|Secondary|Difference in Change in Arterial Stiffness From Baseline|carotid-femoral pulse wave velocity [m/s] measured by Vicorder|4 weeks||||m/s||Standard Deviation|Mean
2679976|NCT01405898|Primary|Difference in Change in Ambulatory Diastolic Blood Pressure From Baseline||4 weeks||||mmHg||Standard Deviation|Mean
2679977|NCT01405898|Primary|Difference in Change in Ambulatory Systolic Blood Pressure From Baseline||4 weeks||||mmHg||Standard Deviation|Mean
2679982|NCT01405820|Primary|Cumulative Number of Combined Unique Active Lesions|Cumulative number of combined unique active lesions (sum of the number of new gadolinium (Gd)-enhancing lesions and new or newly enlarging T2 hyperintense lesions not associated with Gd-enhancement on T1 weighted scans) based on brain magnetic resonance imaging (MRI) scans Up to Week 60.|Up to Week 60|Modified intent-to-treat (mITT) population: all randomized participants who received at least 1 dose of study drug, had at least 1 efficacy assessment, and had no statistical protocol deviations.|||lesions||Standard Deviation|Mean
2679983|NCT01405794|Secondary|Total Change in Heart Rate in Silver Participants|Assessment only completed on the 32ppm Oral Silver part of the trail|Baseline and 14 Days||||beats per minute||95% Confidence Interval|Mean
2679984|NCT01405794|Secondary|Total Change in Diastolic Blood Pressure Silver Participants|Assessment only completed on the 32ppm Oral Silver part of the trail|Baseline and 14 Days||||mmhg||95% Confidence Interval|Mean
2679985|NCT01405794|Secondary|Total Change in Systolic Blood Pressure Silver Participants|Assessment only completed on the 32ppm Oral Silver part of the trail|Baseline and 14 Days||||mmhg||95% Confidence Interval|Mean
2679986|NCT01405794|Primary|Cytochrome P450 Assay on Midazolam in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days||||ng/ml||Standard Deviation|Mean
2679987|NCT01405794|Secondary|Cytochrome P450 Assay on Chlorozoxazone in Participants Dosed With Silver|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days||||ng/ml||Standard Deviation|Mean
2679988|NCT01405794|Primary|Cytochrome P450 Assay on Omeprazole in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days||||ng/ml||Standard Deviation|Mean
2679989|NCT01405794|Primary|Cytochrome P450 Assay on Caffeine in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days||||ng/ml||Standard Deviation|Mean
2679990|NCT01405794|Primary|Cytochrome P450 Assay on Losartan in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days||||ng/ml||Standard Deviation|Mean
2679991|NCT01405794|Primary|Cytochrome P450 Assay on Dextromethorphan in Participants|Assessment Placebo (14 Days) and 32ppm Oral Silver (14 Days). Cytochrome P450 assay is used to determine the function of how Dextromethorphan metabolized. The value represents the peak absorption of the 450 enzyme when dextromethorphan is given during the Silver or Placebo Arm.|14 Days||||ng/ml||Standard Deviation|Mean
2679992|NCT01405794|Primary|Change In Eosinophils Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||percent||Standard Deviation|Mean
2679993|NCT01405794|Primary|Change In Basophils Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||percent||Standard Deviation|Mean
2679994|NCT01405794|Primary|Change In Monocytes Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||percent||Standard Deviation|Mean
2679995|NCT01405794|Primary|Change In Lymphocytes Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||percent||Standard Deviation|Mean
2679996|NCT01405794|Primary|Change In Granulocytes Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||percent||Standard Deviation|Mean
2679997|NCT01405794|Primary|Change In Platelet Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||k/uL||Standard Deviation|Mean
2679998|NCT01405794|Primary|Change In Mean Corpuscular Hemoglobin Concentration Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||gm/dL||Standard Deviation|Mean
2679999|NCT01405794|Primary|Change In Mean Corpuscular Volume Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||fL||Standard Deviation|Mean
2680000|NCT01405794|Primary|Change In Hematocrit Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||percent||Standard Deviation|Mean
2680001|NCT01405794|Primary|Change In Hemoglobin Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||gm/dL||Standard Deviation|Mean
2680002|NCT01405794|Primary|Change In Red Blood Count Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||M/uL||Standard Deviation|Mean
2680003|NCT01405794|Primary|Change In White Blood Count Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||k/uL||Standard Deviation|Mean
2680004|NCT01405794|Primary|Change In Calcium Blood Level|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||mg/dL||Standard Deviation|Mean
2680005|NCT01405794|Primary|Change In Albumin Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||g/dL||Standard Deviation|Mean
2680006|NCT01405794|Primary|Change In Total Bilirubin Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||mg/dL||Standard Deviation|Mean
2680007|NCT01405794|Primary|Change in Total Protein Blood Levels|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||g/dL||Standard Deviation|Mean
2680008|NCT01405794|Primary|Change In Alanine Aminotransferase Blood Level|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||U/L||Standard Deviation|Mean
2680009|NCT01405794|Primary|Change In Aspartate Aminotransferase Blood Level|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||U/L||Standard Deviation|Mean
2680010|NCT01405794|Primary|Change In Alkaline Phosphatase Blood Level|Evaluation of Placebo Group and Silver Particle Group (dose - 32ppm)|14 Days||||U/L||Standard Deviation|Mean
2680018|NCT01405768|Secondary|Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Median)|"A Likert visual analog scale will be used to determine the overall pain experienced by each study participant including injection pain, procedural pain, and cramping.~Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.~Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote no pain were considered to have marked 0 mm."|Within 30 minutes of completion of procedure||||units on a scale||Full Range|Median
2680019|NCT01405768|Primary|Injection Pain Score (Median)|"A Likert visual analog scale will be used to document each study participant's level of pain experienced during injection of the cervical block.~Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.~Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote no pain were considered to have marked 0 mm."|Within 30 minutes of completion of the procedure||||units on a scale||Full Range|Median
2680020|NCT01405768|Secondary|Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Mean)|"A Likert visual analog scale will be used to determine the overall pain experienced by each study participant including injection pain, procedural pain, and cramping.~Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.~Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote no pain were considered to have marked 0 mm."|Within 30 minutes of completion of procedure||||units on a scale||Standard Deviation|Mean
2680021|NCT01405768|Primary|Injection Pain Score (Mean)|"A Likert visual analog scale will be used to document each study participant's level of pain experienced during injection of the cervical block.~Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability.~Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote no pain were considered to have marked 0 mm."|Within 30 minutes of completion of procedure||||units on a scale||Standard Deviation|Mean
2680022|NCT01405742|Secondary|F.VIII Activity|F.VIII Activity (IU/mL) performed at week 8 and week 34, i.e. 8 weeks after initiation of factor dosing in Weeks 1-26, and 8 weeks after initiation of factor dosing in Weeks 27-52.|The time frame is 52 weeks per subject.||||IU/mL||Full Range|Median
2680023|NCT01405742|Secondary|Inter-dose Hypocoagulability by Thrombin Generation|Thrombin generation was performed at week 8 and week 34, i.e. 8 weeks after initiation of factor dosing in Weeks 1-26, and 8 weeks after initiation of factor dosing in Weeks 27-52.|The time frame is 52 weeks per subject.||||nMs||Full Range|Median
2680024|NCT01405742|Primary|Number of Bleeds|The primary outcome was bleed frequency. The data were total number of events for each Arm, and not per-participant.|Weeks 26 (first intervention) and 52 (second intervention)|3 completing study were analyzed|||bleeds per 26 weeks|||Number
2680025|NCT01405560|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment|||percentage of participants|||Number
2680026|NCT01405560|Secondary|Mean Change From Baseline in HCV RNA (Log 10)|"HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered undetectable."|Baseline, Week 2, Week 4, Week 8, Week 12, Week 24|FAS population; all randomized participants who received at least one dose of study treatment.|||Log IU/ml||Standard Deviation|Mean
2680027|NCT01405560|Secondary|Percentage of Participants Achieving Undetectable HCV Ribonucleic Acid (RNA) at the End of Treatment (EOT)|Participants were assessed for undetectable HCV RNA levels at the end of all study therapy. The percentage of participants with undetectable HCV RNA levels at EOT were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 24|FAS population; all randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2680028|NCT01405560|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR)|cEVR was defined as having an undetectable HCV RNA level at Week 12. The percentage of participants achieving cEVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 12|FAS population; all randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2680029|NCT01405560|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR)|RVR was defined as having an undetectable HCV RNA level at Week 4. The percentage of participants achieving RVR were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|At Week 4|FAS population; all randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2684228|NCT01369732|Secondary|the Duration of Hospital Stay|Participants will be followed for the duration of hospital stay, an expected average of 1 month after surgery.|upto 1 month after surgery|||||||
2680030|NCT01405560|Secondary|Percentage of Participants Achieving SVR12|SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy. The percentage of participants achieving SVR12 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|12 weeks after 24 weeks of study therapy (up to 36 weeks)|FAS population; all randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2680031|NCT01405560|Primary|Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an AE. For this study, safety parameters or AEs of special interest that were identified a priori included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal adverse experiences (vomiting, nausea, and diarrhea). The percentage of participants with ≥1 specific AEs were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 48 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment|||percentage of participants||95% Confidence Interval|Number
2680032|NCT01405560|Primary|Percentage of Participants Achieving Sustained Virologic Response (SVR)24|SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy. The percentage of participants achieving SVR24 were reported along with corresponding 95% Clopper-Pearson exact confidence intervals for each treatment regimen.|24 weeks after 24 weeks of study therapy (up to 48 weeks)|Full Analysis Set (FAS) population; all randomized participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2680033|NCT01405508|Secondary|Number of Subjects With at Least One Injection-related Treatment-emergent Adverse Event (TEAE) During the Evaluation Period.|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|4.5-day Evaluation Period|Safety Population consisting of all subjects who took at least 1 dose of study drug.|||Participants|||Number
2680034|NCT01405508|Secondary|Number of Subjects Who Withdrew Due to a Treatment-emergent Adverse Event During the Study (Maximum 40 Days)|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|40 days|Safety Population consisting of all subjects who took at least 1 dose of study drug.|||Participants|||Number
2680035|NCT01405508|Primary|Number of Subjects With at Least One Treatment-emergent Adverse Event During the Study (Maximum 40 Days)|An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.|40 days|Safety Population consisting of all subjects who took at least 1 dose of study drug.|||Participants|||Number
2680036|NCT01405469|Secondary|Percentage of Participants Who Achieved Treatment Success 3 Months After Treatment|"eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. with every meal giving 3 points, daily (2 points), sometimes (1 Point) or no (0 Points), as well as weight loss,(>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms. Post-myotomy eckhardt score ≤ 3 n individuals has been reached in 15 individuals."|3 months after treatment|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.|||percentage of treated patients|||Number
2680037|NCT01405469|Secondary|cm Myotomy Length|myotomy length in cm|POEM procedure|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.|||cm||Standard Deviation|Mean
2680038|NCT01405469|Secondary|Days Duration Hospitalization|participants were followed for the duration of hospital stay, an average of 4 days|days of hospitalization for POEM procedure, an average of 4 days|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.|||days||Standard Deviation|Mean
2680039|NCT01405469|Secondary|Duration Time Procedure|duration time of POEM procedures in minutes|procedure|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.|||minutes||Standard Deviation|Mean
2680040|NCT01405469|Secondary|Medication 3 Months After POEM|proton pump inhibitor (PPI) use at 3 months after POEM procedure|3 months||||participants|||Number
2680041|NCT01405469|Secondary|Number of Participants With Procedure-related Adverse Events|procedure-related adverse events per protocol|procedure to 3 months post procedure||||Participants|||Count of Participants
2680320|NCT01402115|Secondary|Changes in bALP(Bone-specific Alkaline Phosphatase)|bALP(bone-specific alkaline phosphatase) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||U/L||Standard Deviation|Mean
2680042|NCT01405469|Primary|Treatment Success Defined as Symptom Relief 3 Months After Treatment Based on an Eckhardt Score ≤ 3|"eckhardt score is a score to evaluate achalasia discomfort in patients. Patients are being interrogated for dysphagia, regurgitation, and retrosternal pain , correlated with the time frame of occurrence. with every meal giving 3 points, daily (2 points), sometimes (1 Point) or no (0 Points), as well as weight loss,(>10 kg= 3 points, 5-10 kg=2 points, 0-5 kg=1 point, None=0 points. Scale range is from 0 Points (no achalasia) up to 12 points for the worst achalasia symptoms."|3 months after treatment|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.|||Eckardt Score||Standard Deviation|Mean
2680043|NCT01405469|Secondary|Number of Participants With Reflux Symptoms|Number of Participants with Reflux Symptoms during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment|during procedure, and 3 and 6 months, and 1, 2 and 5 years after treatment||||participants|||Number
2680044|NCT01405469|Secondary|mmHg of the Lower Esophageal Sphincter 3 Months After POEM Procedure|esophageal manometry is done 3 months after POEM procedure to evaluate resting lower esophageal sphincter pressure|manometry at 3 month after therapy|Pilot study group to evaluate feasibility and safety of POEM procedure before initiating studies evaluating long-term efficacy.Patients with primary achalasia, diagnosed by established methods(contrast fluoroscopy, manometry, esophagogastroduodenoscopy(EGD)) and age greater than 18 years were included.|||mmHg||Standard Deviation|Mean
2680045|NCT01405456|Secondary|Markers of Immune Activation|MCP-1|6 months||||pg/mL||Standard Error|Mean
2680046|NCT01405456|Secondary|Markers of Systemic Inflammation|IL-6|6 months||||pg/mL||Inter-Quartile Range|Median
2680047|NCT01405456|Secondary|Adiponectin||6 months||||pg/mL||Inter-Quartile Range|Median
2680048|NCT01405456|Secondary|Plasminogen Activator Inhibitor 1||6 months||||ng/mL||Standard Error|Mean
2680049|NCT01405456|Secondary|C-Reactive Protein||6 months||||mg/L||Inter-Quartile Range|Median
2680050|NCT01405456|Secondary|Hemoglobin A1c||6 months||||percentage||Inter-Quartile Range|Median
2680051|NCT01405456|Secondary|Potassium||6 months||||mEq/L||Standard Error|Mean
2680052|NCT01405456|Secondary|Flow Mediated Vasodilation||6 months||||percentage of maximum change||Inter-Quartile Range|Median
2680053|NCT01405456|Secondary|Intramyocellular Lipid||6 months||||percentage of intramyocellular lipid||Inter-Quartile Range|Median
2680054|NCT01405456|Secondary|Liver Fat||6 months||||percentage of intrahepatic lipid||Inter-Quartile Range|Median
2680055|NCT01405456|Secondary|Visceral Adipose Tissue||6 months||||cm^2||Inter-Quartile Range|Median
2680056|NCT01405456|Primary|Insulin Stimulated Glucose Uptake||6 months||||mg/min per μIU/ml||Inter-Quartile Range|Median
2680057|NCT01405313|Secondary|Oxygen Desaturation Index (ODI)|Oxygen desaturation index based on SpO2 measurement of number of dips (number of times per hour of sleep that SpO2 Drops by at least 3% below the basic value) will be recorded, analysed and reported.|One night||||Events per hour||Standard Deviation|Mean
2680058|NCT01405313|Primary|Apnea/Hypopnea Index (AHI)|Physiological sleep signals including pulse oximetry (SpO2), respiratory effort and nasal flow, will be recorded, analysed and reported in the form of an index per hour of sleep. Apnea-Hypopnea Index is calculated counting all apneas (reduction of respiratory flow by >90% for at least 10 seconds) plus all hypopneas (reduction of respiratory flow by >30% for at least 10 seconds with a 4% SpO2 reduction) divided by hours of sleep.|One night||||Events per hour||Standard Deviation|Mean
2680059|NCT01405196|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 4, 8, 12, 16, 20 and 24|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). LOCF method was used to impute missing values.|Baseline, Week 4, 8, 12, 16, 20, 24|"Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis."|||Units on a scale||95% Confidence Interval|Least Squares Mean
2680060|NCT01405196|Secondary|Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline|FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).|Baseline|Full Analysis Set= all randomized participants who received at least 1 dose of study drug. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.|||Units on a scale||Standard Deviation|Mean
2680061|NCT01405196|Secondary|Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24|The SF-6D focuses on seven of the eight health domains covered by the SF-36 Health Survey: physical functioning, role participation (combined role-physical and role-emotional), social functioning, bodily pain, mental health, and vitality. The SF-6D is an attempt to derive a single index from the SF-36 Health Survey for use in economic evaluation studies. As such, it represents a summary score based on a subset of the SF-36 data. Consequently, in lieu of the SF-6D, PCS and MCS SF-36 results are being provided. The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.|Baseline, Week 4, 8, 12, 16, 20, 24|"Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis."|||Units on a scale||95% Confidence Interval|Least Squares Mean
2680062|NCT01405196|Secondary|Change From Baseline in Vitality Scores at Week 4, 8, 12, 16, 20 and 24|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Vitality sub-score is a component of SF-36 Health Survey Questionnaire and assesses energy and fatigue. The vitality score ranged from 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.|Baseline, Week 4, 8, 12, 16, 20, 24|"Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis."|||Units on a scale||95% Confidence Interval|Least Squares Mean
2680063|NCT01405196|Secondary|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24|SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.|Baseline, Week 4, 8, 12, 16, 20, 24|"Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis."|||Units on a scale||95% Confidence Interval|Least Squares Mean
2680064|NCT01405196|Secondary|Thirty Six-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Baseline|SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and mental component score MCS. The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values.|Baseline|Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants evaluable for this outcome measure at specified timepoint. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.|||Units on a scale||Standard Error|Mean
2680065|NCT01405196|Secondary|Change From Baseline in European Quality of Life 5 Dimensions Questionnaire (EQ-5D) at Week 4, 8, 12, 16, 20 and 24|EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point VAS (0= worst imaginable health state, 100= best imaginable health state).|Baseline, Week 4, 8, 12, 16, 20, 24|"Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis."|||Units on a scale||95% Confidence Interval|Least Squares Mean
2680066|NCT01405196|Secondary|Change From Baseline in Patient Global Visual Analog Scale (VAS) at Week 2, 4, 6, 8, 12, 16, 20 and 24|"Participants assessed their disease activity using a 100 mm VAS. Participants answered the following question Considering all the ways your disease affects you, how are you feeling today? Response was recorded by placing a mark on the scale between 0 (very well) and 100 (extremely bad)."|Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24|"Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis."|||mm||95% Confidence Interval|Least Squares Mean
2680067|NCT01405196|Secondary|Patient Global Visual Analog Scale (VAS) Scores at Baseline|"Participants assessed their disease activity using a 100 millimeter (mm) VAS. Participants answered the following question Considering all the ways your disease affects you, how are you feeling today? Response was recorded by placing a mark on the scale between 0 (very well) and 100 (extremely bad)."|Baseline|Full Analysis Set= all randomized participants who received at least 1 dose of study drug. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.|||mm||Standard Error|Mean
2680068|NCT01405196|Secondary|Percentage of Participants With Normalized Serological Activity|Serologic activity was to be assessed in the subgroup of participants who had positive serologic activity at baseline.|Baseline up to Week 24|Consistent with the protocol which pre-specified that if the number of participants with abnormal serological activity at baseline were <25% of overall population, data for this outcome measure was not available.||||||
2680069|NCT01405196|Secondary|Percentage of Participants With Corticosteroid Dose Reduced by Both Greater Than or Equal to (>=) 25 Percent (%) From Baseline and Less Than or Equal to (<=) 7.5 Milligrams Per Day (mg/Day)|Participants were given supplemental corticosteroids at baseline to control disease activity, if necessary. The steroid taper was based on participant's symptoms. Participants recorded their steroid usage on a diary card. Least Observation Carried Forward (LOCF) method was used to impute missing data.|Week 12, 16, 20, 24|Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants evaluable for this outcome measure at specified timepoints. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.|||Percentage of Participants|||Number
2680070|NCT01405196|Secondary|Serum Concentration of PF-04236921|Serum PF-04236921 concentrations over time were summarized.|Day 1, Week 2, 4, 6, 8, 12, 16, 20, 24|"Pharmacokinetic analysis set was the subset of participants from safety analysis set (all participants who received at least 1 dose of investigational product) who provided at least 1 pharmacokinetic concentration. Here, number analyzed signifies those participants who were evaluable at specified time points."|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2684229|NCT01369732|Secondary|the Duration of ICU Stay|Participants will be followed for the duration of ICU stay, an expected average of 2 weeks after surgery.|upto 2 weeks after surgery|||||||
2680071|NCT01405196|Secondary|Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs)|Human serum samples were analyzed for the presence or absence of anti-PF-04236921 antibodies. A positive ADA sample was further tested for neutralizing antibodies using a validated assay.|Baseline up to Week 52|Safety population defined as all participants who had at least one dose of investigational product.|||Participants|||Number
2680072|NCT01405196|Secondary|Number of Participants With Potentially Clinically Important Vital Signs Findings|Criteria for PCI findings in vital signs were defined as: sitting systolic blood pressure (Increase from baseline >=20 millimeter of mercury (mm Hg) and >=160 mm Hg or a decrease from baseline >=20 mm Hg and <=90 mm Hg) and sitting diastolic blood pressure (increase from baseline >=15 mm Hg and >=90 mm Hg or decrease from baseline >=15 mm Hg and <=60 mm Hg), pulse rate (increase from baseline >=15 beats/min and >=120 beats/min or decrease from baseline >=15 beats/min and <=50 beats /min), body temperature (increase of >=2 degree Fahrenheit (F) and temperature >=101 degree F) and weight (change of >=7% in body weight)|Baseline up to Week 52|Safety population defined as all participants who had at least one dose of investigational product.|||Participants|||Number
2680073|NCT01405196|Secondary|Number of Participants With Potentially Clinically Important (PCI) Electrocardiogram (ECG) Findings|Criteria for potentially clinically important (PCI) findings in ECG were defined as: heart rate <=40 beats per minute (bpm) or >=120 bpm; PR interval >=220 millisecond (msec); QT interval >=480 msec; QRS interval >=120 msec; QT interval corrected using the Fridericia formula (QTcF) >=500msec; no sinus rhythm.|Baseline up to Week 52|Safety population defined as all participants who had at least one dose of investigational product. Here, N (Number of participants analyzed) signifies participants evaluable for this outcome measure for each group respectively.|||Participants|||Number
2680074|NCT01405196|Secondary|Number of Participants With Treatment-Emergent Infectious Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. Number of participants with treatment-emergent infectious AEs or SAEs were reported. AEs include both SAEs and non-SAEs.|Baseline up to Week 52|Safety population defined as all participants who had at least one dose of investigational product.|||Participants|||Number
2680075|NCT01405196|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. Number of participants with treatment-emergent AEs or SAEs (excluding infectious AEs or SAEs and injection site reactions) were reported. AEs include both SAEs and non-SAEs.|Baseline up to Week 52|Safety population defined as all participants who had at least one dose of investigational product.|||Participants|||Number
2680076|NCT01405196|Secondary|Number of Participants Who Discontinued Due to Adverse Events|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants who discontinued due to adverse events were reported.|Baseline up to Week 52|Safety population defined as all participants who had at least one dose of investigational product.|||Participants|||Number
2680077|NCT01405196|Secondary|Number of Participants With Clinically Significant Laboratory Tests Results|Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Laboratory values included Alanine Aminotransferase (ALT) [>5.0 - 10.0*Upper limit of normal range (ULN)], Albumin [<26-20 gram per liter (g/L)/ <20 g/L], Amylase [>2.0 - 5.0*ULN], Aspartate Aminotransferase (AST) [>5.0 - 10.0*ULN], Creatine Kinase (CK) [>5.0 - 10.0* ULN/ >10.0*ULN], Glucose (Hyperglycemia) [>13.9 - 27.8 millimoles/liter (mmol/L)], Hemoglobin (HGB) [<80 - 65 g/L/ <65 g/L], Lipase [>2.0 - 5.0*ULN], Lymphocytes (Lymph.)(Absolute [Abs]) [<0.5 - 0.2*10^3/microliter (UL)/ <0.2*10^3/UL], Platelets [<50-25*10^3/UL/ <25*10^3/UL], potassium (low) [<3.0 - 2.5 mmol/L], Sodium (low) [<130 - 120 mmol/L], Total Neutrophils (TN) (Abs) [<1.0 - 0.5*10^3/UL/ <0.5*10^3/UL], Triglycerides [>5.7 - 11.4 mmol/L], White Blood Cell Count (WBC) [<2.0 - 1.0*10^3/UL/ <1.0*10^3/UL].|Baseline up to Week 52|"Safety population defined as all participants who had at least one dose of investigational product. Here, number analyzed signifies those participants who were evaluable at specified time points."|||Participants|||Number
2680078|NCT01405196|Secondary|Percentage of Participants Achieving Pre-defined Criteria for Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Components at Week 24|SRI components include: SLEDAI-2K, BILAG 2004 and PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening(<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids, immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K: assesses improvement in disease activity(range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity (range: A[severe] to E [no disease]). PhGA: assesses worsening in participant's general health status (range: 0[none] to 3[severe]). Model percent estimates reported only for 'Reduction in SLEDAI Score','No Worsening in PhGA' categories; for remaining categories, raw percentages reported|Week 24|Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants who completed through the Week 24 visit. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.|||Percentage of participants|||Number
2680079|NCT01405196|Secondary|Percentage of Participants Achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response at Week 4, 8, 12, 16, 20, and 24|BICLA include: BILAG-2004, SLEDAI-2K, PhGA of disease activity. Participants classified as responder if they did not meet the definition of treatment failure and met all the following criteria: BILAG-2004 improvement (all A scores at baseline improved to B/C/D and all B scores improved to C or D); no worsening in disease activity (no new BILAG-2004 A scores or =<1 new B score); no worsening of total SLEDAI-2K score; no significant deterioration (<10 percent [%] worsening) in analogue PhGA. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. BILAG:assesses disease extent, severity (range: A[severe] to E[no disease]). SLEDAI-2K:assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). PhGA: assesses worsening in participant's general health status(range: 0[none] to 3[severe]).|Week 4, 8, 12, 16, 20, 24|"Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis."|||Percentage of participants|||Number
2680080|NCT01405196|Secondary|Percentage of Participants Achieving Modified Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, 20, and 24|"SRI components include: modified SLEDAI-2K (SLEDAI-2K without standard parameters Low complement and Leukopenia), BILAG 2004, PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids, immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. Modified SLEDAI-2K: assesses improvement in disease activity (range: 0 to 102; higher score = higher severity). BILAG: assesses disease extent, severity (range: A [severe] to E [no disease]). PhGA: assesses worsening in participant's general health status (range: 0[none] to 3[severe])."|Week 4, 8, 12, 16, 20, 24|"Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis."|||Percentage of participants|||Number
2680081|NCT01405196|Secondary|Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, and 20|SRI components include:SLEDAI-2K ,BILAG 2004, PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG:assesses disease extent, severity (range: A [severe] to E [no disease]). PhGA: assesses worsening in participant's general health status(range: 0[none] to 3[severe]).|Week 4, 8, 12, 16, 20|"Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, number analyzed signifies those participants who were evaluable at specified time points. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis."|||Percentage of participants|||Number
2680082|NCT01405196|Primary|Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24|SRI components include:Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K),British Isles Lupus Assessment Group(BILAG) 2004,Physician's Global Assessment(PhGA).Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: greater than or equal to(>=) 4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (less than [<] 0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K:assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG:assesses disease extent, severity (range: A[severe] to E[no disease]). PhGA: assesses worsening in participant's general health status(range: 0[none] to 3[severe]).|Week 24|Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants who completed through the Week 24 visit. As per sponsor’s decision, dosing in “PF-04236921 200 mg” arm was prematurely terminated and hence it was not included in efficacy analysis.|||Percentage of participants|||Number
2680083|NCT01405053|Other Pre-specified|Change From Baseline in Sub-scores in QoLCE|The QoLCE was a 76-item questionnaire designed specifically to measure quality of life in children with epilepsy. QOLCE consists of 16 quality of life subscales (14 multi-item and 2 single item). Each subscales had number of items or questions with responses as excellent, very good, good, fair, and poor. They were changed to 1, 2, 3, 4, and 5 as per instructions. Then changed on a scale of 100, where 1=0, 2=25, 3=50, 4=75, and 5=100. Items corresponding to each subscale were marked and there mean score was score of that subscale. The form was completed by a parent or caregiver who interacted with the child on a consistent, daily basis and took about 20 to 30 minutes to complete. The higher the score, the better the child's quality of life.|Baseline and Week 106|The full analysis set for other efficacy variable included randomized participants who received rufinamide or any other approved add-on AED of the investigator's choice and had a baseline efficacy and at least 1 postbaseline efficacy assessment. Participants evaluable for this outcome measure at given time period were included for assessment.|||score on a scale||Standard Deviation|Mean
2680110|NCT01404650|Primary|Progression-free Survival (PFS)|Measured from time of randomization until objective tumor progression or death; assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Progressive disease (PD) defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest (nadir) sum since the treatment started, or the appearance of one or more new lesions.|At 6 and 12 weeks then every 9 weeks thereafter until progression or intolerable toxicity, up to 4 years.||||months||95% Confidence Interval|Median
2680084|NCT01405053|Other Pre-specified|Change From Baseline in Total Score of Quality of Life in Childhood Epilepsy (QoLCE) Scale|The QoLCE was a 76-item questionnaire designed specifically to measure quality of life in children with epilepsy. QOLCE consists of 16 quality of life subscales (14 multi-item and 2 single item). Each subscales had number of items or questions with responses as excellent, very good, good, fair, and poor. They were changed to 1, 2, 3, 4, and 5 as per instructions. Then changed on a scale of 100, where 1 is equal to (=) 0, 2=25, 3=50, 4=75, and 5=100. Items corresponding to each subscale were marked and there mean score was score of that subscale. The form was completed by a parent or caregiver who interacted with the child on a consistent, daily basis and took about 20 to 30 minutes to complete. The higher the score, the better the child's quality of life.|Baseline and Week 106|The full analysis set for other efficacy variable included randomized participants who received rufinamide or any other add-on AED of the investigator’s choice and had a baseline efficacy assessment and at least 1 postbaseline efficacy assessment. Participants evaluable for this outcome measure at given time period were included for assessment.|||score on a scale||Standard Deviation|Mean
2680085|NCT01405053|Other Pre-specified|Change From Baseline in Language Development Survey (LDS) Scores During Maintenance Period|LDS, a caregiver-administered survey consisted of 8-item questionnaire and vocabulary list of 310 words organized within 14 semantic categories. List contained high frequency words (e.g. more), less common words (e.g. hamburger), and lexical chunks (e.g. Sesame Street). Average LDS score, calculated by dividing total number of words across all valid phrases by number of phrases with greater than (>) 0words; for participants with no words, average was 0. This value was compared to standardized chart to obtain percentile rating. LDS provided 2 scores: average phrase length (number of words/phrase) and number of endorsed vocabulary words. LDS phrase length was categorized into delay (less than or equal to [<=] 20th percentile) and no delay (>20th percentile). LDS vocabulary was categorized into delay(<=15th percentile)and no delay(>15th percentile). Both raw scores were used to provide 2 normative scores based on child's age in months. Higher scores indicated better language development.|Baseline, Weeks 24, 56, 88, and 106|The full analysis set for other efficacy variable included randomized participants who received rufinamide or any other approved add-on AED of the investigator's choice and had a baseline efficacy and at least 1 postbaseline efficacy assessment. Participants evaluable for this outcome measure at given time period were included for assessment.|||words||Standard Deviation|Mean
2680086|NCT01405053|Other Pre-specified|Change From Baseline in CBCL Sub Scores at Week 106|CBCL: 99-item questionnaire, measures behavioral problems/developmental delays, answered by parent/guardian/caregiver. Each item rated on 3-point scale (0=Not True,1=Somewhat/Sometimes True, 2=Very/Often True). 99 items were combined to give scores for 8 problem area scales, where 1 for each 8 syndrome (emotionally reactive, anxious/depressed, somatic, withdrawn, sleep, attention, aggressive behavior, and other problems) were calculated, range: 0 (normal) to 16 (clinical behavior) and 3 summary scores (internalizing, externalizing, and total problems). All 3 summary scores reported scaled to T-scores. Total Problem score was sum of all the problem areas plus 1 additional item, ranging from 0 to 198. Total raw score were converted to t-scores with mean of 50 and SD of 10. T-scores were standardized test scores that indicate same degree of elevation in problems relative to normative sample of peers. Higher scores were indicative of more problems.|Baseline and Week 106|The full analysis set for other efficacy variable included randomized participants who received rufinamide or any other approved add-on AED of the investigator’s choice and had a baseline efficacy and at least 1 postbaseline efficacy assessment. Participants evaluable for this outcome measure at given time period were included for assessment.|||score on a scale||Standard Deviation|Mean
2680087|NCT01405053|Other Pre-specified|Incidence of Worsening of Seizures|Worsening of seizures was summarized by the incidence of participants with doubling in total seizure frequency, doubling in frequency of major seizures (generalized tonic-clonic, drop attacks), or occurrence of new seizure type during each successive 3 to 4 month visit interval of the Maintenance Period relative to baseline.|Baseline up to End of Treatment Period (up to approximately Week 106)|The full analysis set for other efficacy variable included randomized participants who received rufinamide or any other add-on AED of the investigator’s choice and had a baseline efficacy assessment and at least 1 postbaseline efficacy assessment.|||Participants|||Count of Participants
2680088|NCT01405053|Other Pre-specified|Percent Change in Seizure Frequency by Individual Seizure Type Per 28 Days|The frequency per 28 days was defined as (S/D)*28 where, S was equal to the sum of the seizures reported in the participant seizure diary during the specified time interval and D was equal to the number of days with non-missing data in the participant seizure diary for the specified study phase. The number of seizures was assessed and recorded by the participant's parent(s)/caregiver(s) in the participant seizure diary.|Baseline up to End of Treatment Period (up to approximately Week 106)|The full analysis set for other efficacy variable included randomized participants who received rufinamide or any other add-on AED of the investigator’s choice and had a baseline efficacy assessment and at least 1 postbaseline efficacy assessment. Participants evaluable for this outcome measure at given time period were included for assessment.|||percent change in seizure frequency||Full Range|Median
2680089|NCT01405053|Other Pre-specified|Percent Change in Total Seizure Frequency Per 28 Days|The frequency per 28 days was defined as (S/D)*28 where, S was equal to the sum of the seizures reported in the participant seizure diary during the specified time interval and D was equal to the number of days with non-missing data in the participant seizure diary for the specified study phase. The number of seizures was assessed and recorded by the participant's parent(s)/caregiver(s) in the participant seizure diary.|Baseline up to End of the Treatment Period (up to approximately Week 106)|The full analysis set for other efficacy variable included randomized participants who received rufinamide or any other add-on AED of the investigator’s choice and had a baseline efficacy assessment and at least 1 postbaseline efficacy assessment. Participants evaluable for this outcome measure at given time period were included for assessment.|||percent change in seizure frequency||Full Range|Median
2680111|NCT01404611|Primary|Time to Cessation of Otorrhea||From baseline until the end of the study (up to 22 days)||||days||95% Confidence Interval|Median
2680112|NCT01404572|Secondary|Number of Participants With Clinically Relevant Changes in Vital Signs||Study Day 1|All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.||||||
2680113|NCT01404572|Secondary|Number of Participants Who Died and With Adverse Events (AEs) and Serious Adverse Events (SAEs)||Study Day 1|All participants who tasted at least 1 dose of atazanavir|||Participants|||Number
2680090|NCT01405053|Other Pre-specified|Time to Withdrawal From Treatment Due to an Adverse Event or Lack of Efficacy|Withdrawal from either rufinamide or other AED was due to the occurrence of an adverse event or for lack of efficacy. Data was obtained till Week 106 and was extrapolated using Kaplan-Meier method to determine the overall survival time (in weeks) to withdrawal from treatment (excluding taper) due to an adverse event or lack efficacy.|Baseline up to the End of the Treatment Period (up to approximately Week 106)|The full analysis set for other efficacy variable included randomized participants who received rufinamide or any other add-on AED of the investigator’s choice and had a baseline efficacy assessment and at least 1 post baseline efficacy assessment. Participants who were evaluable at a given time point were included for this assessment.|||weeks||95% Confidence Interval|Median
2680091|NCT01405053|Primary|Change From Baseline in CBCL Total Problem T-Scores at End of 2-year Treatment Period|CBCL: 99-item questionnaire measures specific behavioral problems or developmental delays, answered by a parent/legal guardian or suitable caregiver. Each item were rated using 3-point scale (0=Not True, 1=Somewhat/Sometimes True, 2=Very True/ Often True) to indicate how often or typical the behavior was. The 99 items were combined to yield scores for 8 problem area scales (emotionally reactive, anxious/depressed, somatic complaints, withdrawn, sleep problems, attention problems, aggressive behavior, and other problems) and 3 summary scores (internalizing, externalizing, and total problems). Total Problem score was sum of all the problem areas plus 1 additional item, ranging from 0 to 198. Total raw scores are converted to t-scores with mean of 50 and standard deviation (SD) of 10. T-scores were standardized test scores that indicate same degree of elevation in problems relative to the normative sample of peers. Higher scores were indicative of more problems.|Baseline and End of Treatment Period (up to approximately Week 106)|The full analysis set for primary efficacy variable included randomized participants who received rufinamide or any other approved add-on AED of the investigator’s choice and had baseline and at least 1 postdose cognition measurement. Participants who were evaluable for this outcome measure at given time period were included for assessment.|||score on a scale||Standard Deviation|Geometric Mean
2680092|NCT01405053|Primary|Child Behavior Checklist (CBCL) Total Problem T-scores at the End of 2-year Treatment Period|CBCL: 99-item questionnaire measures specific behavioral problems or developmental delays, answered by a parent/legal guardian or suitable caregiver. Each item were rated using 3-point scale (0=Not True, 1=Somewhat/Sometimes True, 2=Very True/ Often True) to indicate how often or typical the behavior was. The 99 items were combined to yield scores for 8 problem area scales (emotionally reactive, anxious/depressed, somatic complaints, withdrawn, sleep problems, attention problems, aggressive behavior, and other problems) and 3 summary scores (internalizing, externalizing, and total problems). Total Problem score was sum of all the problem areas plus 1 additional item, ranging from 0 to 198. Total raw scores are converted to t-scores with mean of 50 and standard deviation (SD) of 10. T-scores were standardized test scores that indicate same degree of elevation in problems relative to the normative sample of peers. Higher scores were indicative of more problems.|End of Treatment Period (up to approximately Week 106)|The full analysis set for primary efficacy variable included randomized participants who received rufinamide or any other approved add-on AED of the investigator’s choice and had baseline and at least 1 postdose cognition measurement. Participants who were evaluable for this outcome measure at given time period were included for assessment.|||score on a scale||Standard Deviation|Mean
2680093|NCT01405027|Secondary|Number of Participants With Adverse Events|Description of the adverse events and rate of events of boceprevir, peginterferon and ribavirin in HCV patients treated at community sites and at HCEEs|Throughout entire study, at end of treatment and follow up week 24||||participants|||Number
2680094|NCT01405027|Secondary|Short Form Health Survey Measuring Quality of Life Reported at Baseline, End of Treatment, and Follow-up Week 24 (36 Multiple Choice Questions)|"Determination of the quality of life for HCV patients treated with boceprevir, peginterferon and ribavirin at community sites and at HCEEs.~Patient scores per subscale (8) were obtained by subtracting the lowest possible raw score from the actual raw score x 100, divided by the lowest possible raw score subtracted from the highest possible raw score. Subscale scores were averaged (with standard deviation) for Group A and Group B. Composite Scores are standardized to the general US population having a mean of 50 and a standard deviation of 10. Higher score = improved quality of life."|Baseline, end of treatment, follow-up week 24|The Quality of Life scores are derived from the responses from subjects who completed questionnaires at protocol-scheduled timepoints.|||score||Standard Deviation|Mean
2680095|NCT01405027|Secondary|Determination of the Rate of Sustained Viral Response (SVR) for HCV Patients Treated With Boceprevir, Peginterferon and Ribavirin at Community Sites and at HCEEs.|Rate of SVR was defined as the percentage of participants with HCV-RNA undetectable at follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm.|Follow-up week 24|Follow-up SVR includes data collected 10 weeks or greater from last treatment.|||percentage of participants|||Number
2680096|NCT01405027|Secondary|Drug Exposure|Total number of patients receiving treatment over specified time intervals.|End of treatment up to treatment week 48||||participants|||Number
2680097|NCT01405027|Primary|Treatment Duration Compliance Rate|The primary objective will be to define treatment duration compliance rate (calculated as the actual treatment duration in weeks divided by the expected duration in weeks) based on individual patient treatment goals as defined in the OPTIMAL protocol for HCV patients treated with boceprevir, peginterferon and ribavirin for up to 48 weeks. Rates will be reported for HCEEs (Group A) and community sites enrolled in the Program (Group B).|End of treatment up to treatment week 48|Population analyzed represents patients who had a PCR at treatment weeks where expected duration of treatment could have been determined. Subjects who discontinued the study due to Treatment Futility were considered to have 100% treatment duration compliance.|||Percentage of compliance||95% Confidence Interval|Mean
2680098|NCT01404988|Secondary|Self-reported Medication Adherence|Assessed using Morisky medication-taking scale. Higher score corresponds to worse adherence.|6 months from baseline||||participants|||Number
2680114|NCT01404572|Secondary|Number of Participants With Abnormal Findings on Electrocardiograms||Study Day 1|All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.||||||
2680115|NCT01404572|Secondary|Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests||Study Day 1|All participants who tasted at least 1 dose of atazanavir. No postdose clinical laboratory assessments were conducted because no participants swallowed any treatment blends.||||||
2680099|NCT01404988|Secondary|Adherence to Beta Blockers|"Refill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available to take. At the original release of the medication, and each subsequent refill, individuals are given enough medication to last a set number of days. This number is referred to as the Days Supply and can be calculated by dividing the number of pills prescribed by the number of pills taken per day. To calculate compliance, the Days Supply is subtracted by the number of days between Actual Refill dates, a time span referred to as the Days Passed. If the Days Passed exceeds the Days Supply the absolute value of the difference represents the number of days the individual was non-adherent. This absolute value is referred to as a Gap. The sum of the Gaps/total number of days passed between the original release of the medication and the final recorded refill date represents non-compliance over that period of time."|6 months from baseline||||proportion of refill compliance||Inter-Quartile Range|Median
2680100|NCT01404988|Secondary|Adherence to ACE Inhibitors and ARB|"Refill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available to take. At the original release of the medication, and each subsequent refill, individuals are given enough medication to last a set number of days. This number is referred to as the Days Supply and can be calculated by dividing the number of pills prescribed by the number of pills taken per day. To calculate compliance, the Days Supply is subtracted by the number of days between Actual Refill dates, a time span referred to as the Days Passed. If the Days Passed exceeds the Days Supply the absolute value of the difference represents the number of days the individual was non-adherent. This absolute value is referred to as a Gap. The sum of the Gaps/total number of days passed between the original release of the medication and the final recorded refill date represents non-compliance over that period of time."|6 months after baseline||||proportion of refill compliance||Inter-Quartile Range|Median
2680101|NCT01404988|Primary|Medication Adherence (Refill Compliance for All HF Medications)|"Refill compliance is an objective measurement of medication adherence that utilizes pharmacy records to assess the proportion of time a patient has medication available to take. At the original release of the medication, and each subsequent refill, individuals are given enough medication to last a set number of days. This number is referred to as the Days Supply and can be calculated by dividing the number of pills prescribed by the number of pills taken per day. To calculate compliance, the Days Supply is subtracted by the number of days between Actual Refill dates, a time span referred to as the Days Passed. If the Days Passed exceeds the Days Supply the absolute value of the difference represents the number of days the individual was non-adherent. This absolute value is referred to as a Gap. The sum of the Gaps/total number of days passed between the original release of the medication and the final recorded refill date represents non-compliance over that period of time."|6 months from baseline visit||||proportion of refill compliance||Inter-Quartile Range|Median
2680102|NCT01404936|Primary|Participants' Response|Complete Response (CR): Disappearance of all clinical evidence of active tumors for a minimum of 8 weeks. Partial Response (PR): 50% or greater decrease in sum of products all measured lesions persisting for at least 4 weeks. No Change: Steady state or change of +/- 25% of tumor size and no progression for minimum of 8 weeks with no appearance of new lesions. Progressive Disease: > 25 % increase in size of any measurable lesion or appearance of significant new lesions.|After 6 courses (3 months)|Two patients did not complete therapy; however, they were included in the intent-to-treat analysis. One patient was censored at the last follow-up date since no events had occurred.|||participants|||Number
2680103|NCT01404923|Primary|Percentage of Improvement of the Total IBSQoL Scores|Improvement of the total IBSQoL scores from baseline to month 6 calculated in percentage|Baseline and 6 Months|The efficacy population included all patients with a calculable IBSQoL score at baseline and at lesat one of the following visit, i.e 173 and 167 patients, respectively in Meteospasmyl and standard of care group.|||% of improvement of IBSQoL total scores||Standard Deviation|Mean
2680104|NCT01404923|Primary|Change From Baseline in Irritable Bowel Syndrome Quality Of Life Overall Score|Irritable Bowel Syndrome Quality of Life total score (IBSQoL) is a health-related Quality of Life (QoL) disease-specific scale adapted for French patients. Total score ranges from minimum=0 to maximum = 100 representing the best outcome.|Baseline and 6 months|The efficacy population included all patients with a calculable IBSQoL score at baseline and at least one of the following visit, i.e 173 and 167 patients, respectively in Meteospasmyl and standard of care group.|||units on a scale||Standard Error|Mean
2680105|NCT01404832|Secondary|Number of Patients Who Had Resolution of Heartburn With Lansoprazole|Resolution of heartburn defined as >50% improvement in symptoms|After 8 weeks of treatment||||participants|||Number
2680106|NCT01404832|Primary|Number of Participants With Eosinophilic Esophagitis||8 weeks||||participants|||Number
2680107|NCT01404650|Secondary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Worst toxicity grades per patient were tabulated for select adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.0|Days 1, 8 and 15 of each 21-day cycle plus 30 days after treatment discontinuation.|All participants who received at least one dose of study drug.|||participants|||Number
2680108|NCT01404650|Secondary|Overall Survival (OS)|Evidence of survival was obtained by clinic visit or telephone contact from the time of first dose until death from any cause.|Every 3 months until patient death or lost to follow-up, for up to 4 years.|All 25 patients who received treatment were included in the analysis of overall survival.|||months||95% Confidence Interval|Median
2680109|NCT01404650|Secondary|Response Rate (RR)|Defined as the proportion of complete and partial responses, assessed per RECIST v1.1. Complete response (CR) defined as a disappearance of all lesions; partial response (PR) defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking the baseline sum LD as reference. Stable Disease (SD) defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for progressive disease, taking as reference the smallest (nadir) sum LD since start of treatment.|At 6 and 12 weeks then every 9 weeks thereafter until progressive disease or intolerable toxicity, for up to 4 years.|Of 25 patients enrolled, 4 patients were not evaluable for response due to treatment discontinuation prior to first disease evaluation.|||percentage of participants|||Number
2680321|NCT01402115|Secondary|Changes in CTx(Collagen Type 1 Cross-linked C-telopeptide)|CTx(collagen type 1 cross-linked C-telopeptide) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||µg/L||Standard Deviation|Mean
2680116|NCT01404572|Primary|Mean Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir|Tasting atazanavir (15 mg, administered as a 5 mL oral suspension) was defined as taking the sample into the mouth, swishing it across the tongue for approximately 30 seconds without swallowing, and then spitting it out. Immediately after tasting each treatment, participants scored the treatments for sweetness using a subjective sweet intensity scoring system: 0=not sweet, 1=mildly sweet, 2=moderately sweet, 3=very sweet. Participants were permitted to select a whole or half score number (for example, 1.5) between the minimum score of 0 and the maximum score of 3.0. The higher the score, the greater the sweetness.|Study Day 1|All participants who tasted at least 1 dose of atazanavir|||Units on a scale||Standard Deviation|Mean
2680117|NCT01404572|Secondary|Mean Palatability Score for Current and New Powder for Oral Use (POU) Formulations of Atazanavir|Overall palatability was scored on a scale of 1 through 5, with 1 being least palatable and 5 being most palatable. Only whole score numbers were accepted.|Study Day 1|All participants who tasted at least 1 dose of atazanavir|||Units on a scale||Standard Deviation|Mean
2680118|NCT01404572|Secondary|Median Palatability Score for Current and New Powder for Oral Use Formulations of Atazanavir|Overall palatability was scored on a scale of 1 through 5, with 1 being least palatable and 5 being most palatable. Only whole score numbers were accepted.|Study Day 1|All participants who tasted at least 1 dose of atazanavir|||Units on a scale||Full Range|Median
2680119|NCT01404572|Primary|Median Scores on a Subjective Sweet Intensity Scale for Current and New Powder for Oral Use (POU) Formulations of Atazanavir|Tasting atazanavir (15 mg, administered as a 5 mL oral suspension) was defined as taking the sample into the mouth, swishing it across the tongue for approximately 30 seconds without swallowing, and then spitting it out. Immediately after tasting each treatment, participants scored the treatments for sweetness using a subjective sweet intensity scoring system: 0=not sweet, 1=mildly sweet, 2=moderately sweet, 3=very sweet. Participants were permitted to select a whole or half score number (for example, 1.5) between the minimum score of 0 and the maximum score of 3.0. The higher the score, the greater the sweetness.|Study Day 1|All participants who tasted at least 1 dose of atazanavir|||Units on a scale||Full Range|Median
2680120|NCT01404559|Primary|Bioenergetics Between Feet Components 21 Days After Fitting Prostheses|Measures of energy expenditure while walking on a treadmill were measured. Expired gas (e.g. oxygen and carbon dioxide) are breathed into a face mask worn by participants. The mask contains sensors to detect the levels of the respective gas. Oxygen uptake is correlated with effort to ambulate and therefore, the more oxygen consumed during walking, the more difficult the bout of activity. Thus, if one prosthetic foot requires the consumption of more or less oxygen than other feet, then this is an indicator of the relative difficulty of walking with that particular foot condition.|21 days total (7days per prosthetic foot condition)||||ml O2/kg/min||Standard Deviation|Mean
2680121|NCT01404559|Primary|Obstacle Course Completion Time|Laser timing lights were used to measure time necessary to complete a 17 task obstacle course. Participants trigger the laser timing lights when they run past them and the times are recorded in a laptop computer. Laser lights are set up in pairs at the beginning and end of the obstacle course.|21 days total (7days per prosthetic foot condition)||||seconds||Standard Deviation|Mean
2680122|NCT01404429|Secondary|Proportion Who Withdrew Due to Intolerance||3 months||||participants|||Number
2680123|NCT01404429|Secondary|Proportion Requiring Stoppage/Decrease/Inability to Hike MTX Due to Cytopenia or Transaminitis (SGOT or SGPT More Than 80IU)||3 months|||||||
2680124|NCT01404429|Secondary|Proportion of Patients Who Withdrew Because of Any Cause||3 months||||participants|||Number
2680125|NCT01404429|Primary|Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2)||3 months||||participants|||Number
2680126|NCT01404429|Primary|Mean Change in the DAS28-3 (Disease Activity Score Using 28 Joints and Using 3 Variables) - Difference Between This Score at 12 Weeks and This Score at Baseline|DAS28-3 is disease activity score using 28 joints and using 3 variables (tender and swollen joint count for 28 joints and ESR(westergren 1st hour) It ranges from 0 to 9.3 where a lower value implies lower disease activity|12 weeks||||units on a scale||Standard Deviation|Mean
2680127|NCT01404325|Secondary|High-Density Lipoprotein (HDL)Cholesterol Levels at Month 1, 3, 6, 9, 12|HDL Cholesterol levels at Month 1, 3, 6, 9, 12|Month 1, 3, 6, 9, 12|Safety Set consisted of all patients that received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. Patients were analyzed according to treatment received. Of note, the statement that a patient had no AEs also constituted a safety assessment.|||mmol/L||Standard Deviation|Mean
2680128|NCT01404325|Secondary|Low-Density Lipoprotein (LDL)Cholesterol Levels at Month 1, 3, 6, 9, 12|LDL Cholesterol levels at Month 1, 3, 6, 9, 12|Month 1, 3, 6, 9, 12|Safety Set consisted of all patients that received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. Patients were analyzed according to treatment received. Of note, the statement that a patient had no AEs also constituted a safety assessment.|||mmol/L||Standard Deviation|Mean
2680129|NCT01404325|Secondary|Total Cholesterol Levels at Month 1, 3, 6, 9, 12|Total Cholesterol levels at Month 1, 3, 6, 9, 12|Month 1, 3, 6, 9, 12|Safety Set consisted of all patients that received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. Patients were analyzed according to treatment received. Of note, the statement that a patient had no AEs also constituted a safety assessment.|||mmol/L||Standard Deviation|Mean
2680130|NCT01404325|Secondary|Triglyceride Levels at Month 1, 3, 6, 9, 12|Triglyceride levels at Month 1, 3, 6, 9, 12|Month 1, 3, 6, 9, 12|Safety Set consisted of all patients that received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. Patients were analyzed according to treatment received. Of note, the statement that a patient had no AEs also constituted a safety assessment.|||mmol/L||Standard Deviation|Mean
2680131|NCT01404325|Secondary|Incidence of Bacterial, Viral, and Fungal Infections at Month 12|Incidence of bacterial, viral, and fungal infections at Month 12|Month 12|Safety Set consisted of all patients that received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. Patients were analyzed according to treatment received. Of note, the statement that a patient had no AEs also constituted a safety assessment.|||incidences|||Number
2680155|NCT01404312|Secondary|Nevirapine (NVP) Plasma Concentrations in Arm A|Mean and standard deviation|Measured at Weeks 0, 2, and 4|Only measured in the first 90 participants randomized to Arm A who enter the study taking NVP and who meet dose timing criteria. For weeks 0, 2, 4, some samples were missing or contaminated.|||nanograms per mL||Standard Deviation|Mean
2680132|NCT01404325|Secondary|Adherence to Target Ranges of Tacrolimus at Month 1, 3, 6, 9, 12|Adherence to target ranges of Tacrolimus at Month 1, 3, 6, 9, 12|Month 1, 3, 6, 9, 12|Safety Set consisted of all patients that received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. Patients were analyzed according to treatment received. Of note, the statement that a patient had no AEs also constituted a safety assessment.|||participant adherence|||Number
2680133|NCT01404325|Secondary|Trough Levels of Tacrolimus at Month 1, 3, 6, 9, 12|Trough levels of Tacrolimus at Month 1, 3, 6, 9, 12|Month 1, 3, 6, 9, 12|Safety Set consisted of all patients that received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. Patients were analyzed according to treatment received. Of note, the statement that a patient had no AEs also constituted a safety assessment.|||ng/mL||Standard Deviation|Mean
2680134|NCT01404325|Secondary|Adherence to Target Ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12|Adherence to target ranges of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12|Month 1, 3, 6, 9, 12|Safety Set consisted of all patients that received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. Patients were analyzed according to treatment received. Of note, the statement that a patient had no AEs also constituted a safety assessment.|||participant adherence|||Number
2680135|NCT01404325|Secondary|Trough Levels of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12|Trough levels of Cyclosporine A (CsA) at Month 1, 3, 6, 9, 12|Month 1, 3, 6, 9, 12|Safety Set consisted of all patients that received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. Patients were analyzed according to treatment received. Of note, the statement that a patient had no AEs also constituted a safety assessment.|||ng/mL||Standard Deviation|Mean
2680136|NCT01404325|Secondary|Adherence to Target Ranges of Everolimus at Month 1, 3, 6, 9, 12|Adherence to target ranges of everolimus at Month 1, 3, 6, 9, 12|Month 1, 3, 6, 9, 12|Safety Set consisted of all patients that received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. Patients were analyzed according to treatment received. Of note, the statement that a patient had no AEs also constituted a safety assessment.|||participant adherence|||Number
2680137|NCT01404325|Secondary|Trough Levels of Everolimus at Month 1, 3, 6, 9, 12|Trough levels of everolimus at Month 1, 3, 6, 9, 12|Month 1, 3, 6, 9, 12|Safety Set consisted of all patients that received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. Patients were analyzed according to treatment received. Of note, the statement that a patient had no AEs also constituted a safety assessment.|||ng/mL||Standard Deviation|Mean
2680138|NCT01404325|Secondary|Incidence of Diabetes Mellitus up to Month 12|Incidence of Diabetes Mellitus up to Month 12|up to Month 12|Full Analysis Set (FAS) consisted of all patients as randomized that received at least 1 dose of study drug and had a valid baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||incidences|||Number
2680139|NCT01404325|Secondary|Incidence of Treated Arterial Hypertension up to Month 12|Incidence of treated of arterial hypertension up to Month 12|up to Month 12|Full Analysis Set (FAS) consisted of all patients as randomized that received at least 1 dose of study drug and had a valid baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||incidences|||Number
2680140|NCT01404325|Secondary|Exercise Capacity 6-Minute Walk Test(6MWT) at Month 6 and Month 12|Exercise capacity (6MWT) at Month 6 and Month 12 Measured by the Borg Scale. THE BORG SCALE 0 is Nothing at all, 0.5 is Very, very slight (just noticeable); 1 is Very slight, 2 is Slight (light); 3 is Moderate; 4 is Somewhat severe; 5 is Severe (heavy), 7 is Very severe, 10 is Very, very severe (maximal)The higher the Borg score implies increased shortness of breath and/or increased fatigue.|Month 6, Month 12|Full Analysis Set (FAS) consisted of all patients as randomized that received at least 1 dose of study drug and had a valid baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Scores on a scale||Standard Deviation|Mean
2680141|NCT01404325|Secondary|Quality of Life (QoL, SF36) at Month 6 and Month 12|Quality of Life (QoL, SF36) at Month 6 and Month 12 Scores can range from a minimum of 0 (maximum disability) to a maximum of 100 (no disability).|Month 6, Month 12|Full Analysis Set (FAS) consisted of all patients as randomized that received at least 1 dose of study drug and had a valid baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||scores on a scale||Standard Deviation|Mean
2680142|NCT01404325|Secondary|Incidence of Death at Month 6 and Month 12|Incidence of death at Month 6 and Month 12|Month 6, Month 12|Safety Set consisted of all patients that received at least 1 dose of study drug and had at least 1 post-baseline safety assessment. Patients were analyzed according to treatment received. Of note, the statement that a patient had no AEs also constituted a safety assessment.|||incidences|||Number
2680143|NCT01404325|Secondary|Incidence of Bronchiolitis Obliterans Syndrome (BOS) at Month 6 and Month 12|Incidence of Bronchiolitis obliterans syndrome (BOS) at Month 6 and Month 12 BOS 0 is FEV1 > 90% of baseline and FEF25-75% > 75% of baseline; BOS 0-p is FEV1 81-90% of baseline and/or FEF25-75% ≤ 75% of baseline; BOS 1 is FEV1 66-80% of baseline; BOS 2 is FEV1 51-65% of baseline; BOS 3 is FEV1 ≤ 50% of baseline|Month 6, Month 12|Full Analysis Set (FAS) consisted of all patients as randomized that received at least 1 dose of study drug and had a valid baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||incidences|||Number
2680144|NCT01404325|Secondary|Incidence of Graft Loss/Re-transplantation at Month 6 and Month 12|Incidence of graft loss/re-transplantation at Month 6 and Month 12|Month 6, Month 12|Full Analysis Set (FAS) consisted of all patients as randomized that received at least 1 dose of study drug and had a valid baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||incidences|||Number
2680171|NCT01404234|Secondary|Percentage of Participants Who Used Additional (Non-study) Antipseudomonal Antibiotics|The percentage of participants who used additional (non-study) antipseudomonal antibiotics (IV, inhaled, oral, IV/inhaled, IV/inhaled/oral) was summarized (number and percent) for all subjects.|Baseline to Day 168|Full Analysis Set|||percentage of participants|||Number
2680145|NCT01404325|Secondary|Incidence of Acute Rejection Episodes at Month 6 and Month 12|"Incidence of acute rejection episodes at Month 6 and Month 12. This table counts multiple occurrences of rejection in the same patient as different incidents. Every incident is associated with both an A and a B classification.~Classification A: Acute Rejection Grade 0 - none, Grade 1-minimal, Grade 2- mild, Grade 3-moderate, Grade 4-Severe; Classification B: Airway Inflammation-Grade 0-none, Grade 1R-low grade, Grade 2R-high grade, Grade X-ungradeable"|Month 6, Month 12|Full Analysis Set (FAS) consisted of all patients as randomized that received at least 1 dose of study drug and had a valid baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||incidences|||Number
2680146|NCT01404325|Secondary|Time to Renal Replacement Therapy at Month 6 and Month 12|Time to renal replacement therapy at Month 6 and Month 12: There were no incidences in either group where renal replacement therapy was required|Month 6, Month 12|Full Analysis Set (FAS) consisted of all patients as randomized that received at least 1 dose of study drug and had a valid baseline assessment of the primary efficacy variable. The outcome could not be analyzed because there were no incidences of renal replacement therapy||||||
2680147|NCT01404325|Secondary|Incidence of Renal Replacement Therapy at Month 6 and Month 12|Incidence of renal replacement therapy at Month 6 and Month 12: There were no incidences in either group where renal replacement therapy was required|Month 6, Month 12|Full Analysis Set (FAS) consisted of all patients as randomized that received at least 1 dose of study drug and had a valid baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||incidences|||Number
2680148|NCT01404325|Secondary|Incidence of Patients Experiencing a Decline in GFR of < 10, 10-15, 15-20, 20-25 and > 25 mL/Min From Baseline to Month 6 and 12.|Incidence of patients experiencing a decline in GFR of < 10, 10-15, 15-20, 20-25 and > 25 mL/min from Baseline to Month 6 and 12calculated by the CKD-EPI method. Participants are counted in each decline level observed for that participant; this means participants may be counted in more than 1 decline level.|Baseline, Month 6, Month 12|Full Analysis Set (FAS) consisted of all patients as randomized that received at least 1 dose of study drug and had a valid baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||incidences|||Number
2680149|NCT01404325|Secondary|Calculated Glomerular Filtration Rate (cGFR) According to Cockcroft-Gault at Month 1, 3, 6, 9, 12|Calculated Glomerular Filtration Rate (cGFR) according to Cockcroft-Gault at Month 1, 3, 6, 9, 12 For men: GFR=(140-Age) x Body weight (kg) / 72 x Serum Creatinine (mg/dl) For women: GFR=0.85 (140 -Age) x Body weight(kg)/ 72 x Serum Creatinine (mg/dl)|Month 1, 3, 6, 9, 12|Full Analysis Set (FAS) consisted of all patients as randomized that received at least 1 dose of study drug and had a valid baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||mL/min||Standard Deviation|Mean
2680150|NCT01404325|Secondary|Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 1, 3, 6, 9, 12|Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at Month 1, 3, 6, 9, 12 cGFR (in mL/min/1.73 m2) = 186.3*(C-1.154)*(A-0.203)*G*R where C = the serum concentration of creatinine (mg/dL), A = age (years), G = 0.742 when gender is female, otherwise G = 1, R = 1.21 when race is black, otherwise R = 1.|Month 1, 3, 6, 9, 12|Full Analysis Set (FAS) consisted of all patients as randomized that received at least 1 dose of study drug and had a valid baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||mL/min||Standard Deviation|Mean
2680151|NCT01404325|Secondary|Calculated Glomerular Filtration Rate (cGFR) According to Cystatin C-based Hoek's Formula at Month 1, 3, 6, 9, 12|Calculated Glomerular Filtration Rate (cGFR) according to Cystatin C-based Hoek's formula at Month 1, 3, 6, 9, 12|Month 1, 3, 6, 9, 12|Full Analysis Set (FAS) consisted of all patients as randomized that received at least 1 dose of study drug and had a valid baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||mL/min||Standard Deviation|Mean
2680152|NCT01404325|Secondary|Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at Month 1, 3, 6, 9, 12|Calculated Glomerular Filtration Rate (cGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at Month 1, 3, 6, 9 and 12. The CKD-EPI equation, expressed as a single equation, is GFR = 141 × min(Scr/κ, 1)α × max(Scr/κ, 1)^-1.209 × 0.993Age × 1.018 (if female) × 1.159 (if black), where Scr is serum creatinine, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/ĸ or 1, and max indicates the maximum of Scr/κ or 1|Month 1, 3, 6, 9, 12|Full Analysis Set (FAS) consisted of all patients as randomized that received at least 1 dose of study drug and had a valid baseline assessment of the primary efficacy variable. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||mL/min||Standard Deviation|Mean
2680153|NCT01404325|Primary|Calculated Glomerular Filtration Rate (cGFR) According to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 Months|Calculated Glomerular Filtration Rate (cGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) at 12 months The CKD-EPI equation, expressed as a single equation, is GFR = 141 × min(Scr/κ, 1)α × max(Scr/κ, 1)^-1.209 × 0.993Age × 1.018 (if female) × 1.159 (if black), where Scr is serum creatinine, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/ĸ or 1, and max indicates the maximum of Scr/κ or 1|Month 12|Full Analysis Set multiple imputation (FAS MI) consisted of all patients as randomized that received at least 1 dose of study drug & had a valid baseline assessment of the primary efficacy variable. Missing values was dealt with by multiple imputation (MI)|||mL/min||95% Confidence Interval|Least Squares Mean
2680154|NCT01404312|Secondary|EFV Plasma Concentrations in Arm B|"For Version 2.0 of the protocol only, measured in the first 90 participants randomized to Arm B who enter the study taking EFV and who meet dose timing criteria.~Samples have not yet been analyzed because the metabolite assay is being validated, and requires submission for approval by the Clinical Pharmacology Quality Assurance Program."|Measured at weeks 0, 2 and 4||2020-12-31|12/2020||||
2680156|NCT01404312|Secondary|Efavirenz (EFV) Plasma Concentrations in Arm A|"Mean and standard deviation.~Week 16 samples have not yet been analyzed because the metabolite assay is being validated, and requires submission for approval by the Clinical Pharmacology Quality Assurance Program. Analysis of week 16 samples are anticipated to be available in September 2019."|Measured at Weeks 0, 2, 4, and 16|Only measured in the first 90 participants randomized to Arm A who entered the study taking EFV and who meet dose timing criteria; and, under Version 2.0 of the protocol, at Weeks 0, 2, 4, and 16 in the first 30 participants randomized to Arm A who enter the study taking EFV and who meet dose timing criteria.|||nanograms per mL||Standard Deviation|Mean
2680157|NCT01404312|Secondary|Number of Participants With Antibiotic Resistance Among Mycobacterium Tuberculosis (MTB) Isolates in Participants Who Develop Active Tuberculosis|Among MTB-diagnosed participants who underwent drug-susceptibility testing, the number who had any resistance to a particular drug.|After TB diagnosis|Participants with a culture-confirmed TB diagnosis who underwent drug susceptibility testing|||Participants|||Count of Participants
2680158|NCT01404312|Secondary|Cumulative Incidence of Death Due to a Non-TB Event|Cumulative incidence function estimated nonparametrically, treating TB-related deaths as competing risks.|From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)|All participants who started study treatment|||events per 100 participants|||Number
2680159|NCT01404312|Secondary|Cumulative Incidence of Death From Any Cause|Data table estimates for percentage who died by each time point were estimated using Kaplan-Meier at 1, 2, 3, and 4 years post-entry.|From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)|All Participants who started study treatment|||events per 100 participants|||Number
2680160|NCT01404312|Secondary|Number of Participants in Each Category of Ordered Categorical Variable Indicating Most Stringent Level of Study Drug Management Due to Toxicity That Was Required Over the Treatment Period|"Ordered categories include:~Premature permanent treatment discontinuation~Treatment hold for more than 7 consecutive days~None of the above"|From entry to end of treatment (up to 8 weeks for Arm A; up to 54 weeks for Arm B)|All participants who started study treatment|||Participants|||Count of Participants
2680161|NCT01404312|Secondary|Number of Participants With a Targeted Adverse Event|Targeted adverse events include each new grade 3 or 4 laboratory value or sign or symptom that is at least one grade increase from baseline for the following: nausea and vomiting; cutaneous; drug-associated fever; elevated aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]), or bilirubin; and peripheral neuropathy|From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)|All participants who started study treatment|||Participants|||Count of Participants
2680162|NCT01404312|Secondary|Number of Participants With Occurrence of One or More Serious Adverse Events (SAEs) Versus no SAEs|Occurrence of any SAE that meets the ICH definition of an SAE|From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)|All participants who started study treatment|||Participants|||Count of Participants
2680163|NCT01404312|Primary|Incidence of First Diagnosis of Active Tuberculosis, Death Related to Tuberculosis, or Death From Unknown Cause|Incidence rate (events per 100 person-years) was estimated, and 95.1% confidence interval used to account for interim analysis of primary efficacy outcome.|From entry to occurrence of event, up to end of follow-up 3 years after last participant enrolled (median follow-up time: 3.3 years)|All participants who started study treatment.|||Events per 100 person-years||95.1% Confidence Interval|Number
2680164|NCT01404260|Primary|Progression Free Survival|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter ever recorded since study treatment started, or progression in existing non-target lesions,or the appearance of one or more new lesions .|The evaluation of disease is demanded every two months for the patients receiving maintenance use of Gefitinib or patients in observation after chemotherapy,until disease progression occured|Efficacy analysis, including PFS will be based on intent to treat (ITT) population.. ITT population includes all the randomised patients who receive at least one dose of study treatment with at least one baseline data of volume of plaque and at least one data after treatment.|||months||95% Confidence Interval|Median
2680165|NCT01404234|Secondary|Adverse Event Rates Adjusted for Study Duration|Adverse events occurring in ≥ 5% of participants adjusted for study duration were summarized. The adjustment was made by using a standardized rate calculated as the sum of study duration across patients divided by 28 for the total number of patient months. Rate calculations presented are the number of adverse events (AEs) per patient month.|Baseline to Day 168|Full Analysis Set|||AEs (per patient month)|||Number
2680166|NCT01404234|Secondary|Percentage of Participants With Study-drug Induced Bronchospasm|Study-drug induced bronchospasm (airway reactivity) was assessed at the baseline visit as the percent change in FEV1 from the pretreatment measurement to 30 minutes following treatment for subjects ≥ 6 years or as from the Investigator's assessment for subjects < 6 years.|Pretreatment at Baseline to 30 minutes following treatment|Full Analysis Set|||percentage of participants|||Number
2680167|NCT01404234|Secondary|Time to Pulmonary Exacerbation|The median days to first pulmonary exacerbation was summarized using Kaplan-Meier (KM) summary statistics.|Baseline to Day 168|Full Analysis Set|||days||95% Confidence Interval|Median
2680168|NCT01404234|Secondary|Percentage of Participants With Pulmonary Exacerbations|Pulmonary exacerbations were defined as respiratory hospitalizations or discrete courses of non-study IV/inhaled antipseudomonal antibiotics. Use of oral antibiotics alone for respiratory signs or symptoms was considered to be representative of milder clinical events and, therefore, was not included in the definition of pulmonary exacerbations.|Baseline to Day 168|Full Analysis Set|||percentage of participants|||Number
2680169|NCT01404234|Secondary|Number of Days Participants Were Hospitalized Due to a Respiratory Event|The average number of days hospitalized due to a respiratory event, among the 11 participants who were hospitalized for respiratory event, was reported.|Baseline to Day 168|Full Analysis Set|||days||Standard Deviation|Mean
2680170|NCT01404234|Secondary|Percentage of Participants Hospitalized at Least Once Due to a Respiratory Event||Baseline to Day 168|Full Analysis Set|||percentage of participants|||Number
2680173|NCT01404234|Secondary|Change From Baseline in CFQ-R Respiratory Symptoms Scale (RSS) Score in Subjects Aged ≥ 6 Years|"The change in CFQ-R RSS score was assessed at the end of each 28-day AZLI treatment course.~The range of scores (units) was 0 to 100 with higher scores indicating fewer symptoms."|Baseline to Day 28, 84, and 140|Participants in the Full Analysis Set ≥ 6 years of age were analyzed.|||units on a scale||Standard Deviation|Mean
2680174|NCT01404234|Secondary|Change From Baseline in FEV1 % Predicted in Subjects Aged ≥ 6 Years|"The change in FEV1 % predicted was assessed at the end of each 28-day AZLI treatment course.~FEV1 % predicted is defined as FEV1 of the patient divided by the average FEV1 in the population for any person of similar age, sex, race, and body composition."|Baseline to Day 28, 84, and 140|Participants in the Full Analysis Set ≥ 6 years of age were analyzed.|||percentage of FEV1 % predicted||Standard Deviation|Mean
2680175|NCT01404234|Primary|Percentage of Participants Who Discontinued Study Drug Due to Safety or Tolerability Reasons|"Participants who discontinued study drug due to safety or tolerability reasons were defined as those with Adverse Event (AE)/Safety or Tolerability on the Study Drug Completion electronic case report form as the reason for early discontinuation. The 95% confidence interval (CI) was calculated using the exact binomial method."|Baseline to Day 168|Participants in the Full Analysis Set (enrolled and received at least 1 dose of study medication) who completed the study or discontinued study drug due to safety or tolerability reasons were analyzed. Two participants voluntarily withdrew from the study prior to completion (not due to AEs/safety or tolerability reasons).|||percentage of participants||95% Confidence Interval|Number
2680176|NCT01404208|Secondary|Clinical Global Impression-Severity (CGI-Severity)|The Clinical Global Impression-Severity is a 7-point clinician rating of illness severity, with a score of 0 indicating no illness and a score of 6 indicating extremely severe symptoms. Because the secondary outcome was the change in score from randomization to post treatment, a more negative score indicates a greater reduction in symptom severity.|Change from Randomization Point to Post Treatment||||Change in score from randomization||Standard Deviation|Mean
2680177|NCT01404208|Primary|Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)|The CY-BOCS is a measure of severity of OCD symptoms, including interference, time spent on thoughts or behaviors, distress, resistance, etc. The CY-BOCS is measured from 0 to 40, with larger values indicating more severe symptoms. Our outcome measure was the difference between the post treatment and randomization scores. When those values are negative, it indicates a reduction in symptom severity.|Change from Score at Randomization to Post Treatment||||Change in score from randomization||Standard Deviation|Mean
2680178|NCT01404078|Secondary|Blood Pressure Reduction and Lipid Lowering in Type 2 Diabetics||8 weeks|||||||
2680179|NCT01404078|Primary|Tolerability of a Double Dose of Half Strength Polycap||8 weeks|||||||
2680180|NCT01404078|Primary|BLOOD PRESSURE LIPIDS|Amongst patients with cardiovascular disease or type 2 diabetes, the study aims to test the safety and efficacy of giving double dose of polycap versus a single dose of polycap for 8 weeks; efficacy to lower blood pressure and elevated lipids and safety assessed as difference with tolerance to double dose of polycap compared to a single dose.|8 weeks||||mmHG||95% Confidence Interval|Mean
2680181|NCT01404039|Primary|Change in Motor Cortex Excitability MEP Amplitude|"We aim to assess the effects of the intervention (ML, SL, OT and MI) on motor cortex excitability as measured by the change in motor evoked potential (using transcranial magnetic stimulation) before and after the given intervention.~For ML: MEP will be measured before and after each ML sessions in the same subject (crossover design - ML sighted/MLblind/ML control).~For SL: MEP will be measured before and after the treatment session in the each groups (parallel design - 1 session per group).~For OT: MEP will be measured before and after the treatment session in the each groups (parallel - 1 session per group).~For MI: MEP will be measured before and after the treatment session in the each groups (parallel design - 1 session per group)."|after each intervention|"ML: crossover design - ML sighted/MLblind/ML control. 15 patients were enrolled, but one participant dropped-out after the first intervention - participants with available data: 14.~SL: parallel design - SL sighted/SLblind/Sactivation/SLcontrol. OT: parallel design - OT real and OT control. MI: parallel design - MI real and MI control."|||microV||Standard Deviation|Mean
2680182|NCT01403987|Secondary|Readmission and Mortality Rates|Percentage of patients in each arm that were either readmitted within 30 days or died within 90 days (ie a combined endpoint of either/or readmission or death)|18 months||||percentage of patients|||Number
2680183|NCT01403987|Secondary|Improvement in Guideline Adherence|Improvement in adherence to AASLD guidelines is summarized as yes or no improvement based on investigator chart review performed prior to and after the intervention. This is not a measure of resident reporting adherence but rather investigator interpretation of patient care and whether care was in line with published guidelines.|18 months||||percentage of participants|||Number
2680184|NCT01403987|Primary|Score Out of Total Possible 25 on a Likert Scale.|"Primary outcome is quantified by summation of Likert scale responses to five questions assessing for comfort level in caring for and managing inpatients with ascites. The scale ranges from strongly disagree, which is assigned a value of 1, to strongly agree, assigned a value of 5. The summation scores will therefore range from 5 to 25 points out of a total of 25 possible points. The post-intervention scores will be compared between groups using a multiple regression model with terms for treatment, baseline summary scores, and other baseline demographic variables as needed."|6 months|Those who provided both baseline and follow up surveys|||units on a Likert scale (maximum is 25)||Standard Deviation|Mean
2680185|NCT01403805|Other Pre-specified|Died Before Oral Care Starting|Number of resident died before the start of oral care|This participant was died before treatment, Day 1|"This participant was determined as Not Completed due to Died before oral care starting. We excluded this participant from analysis for outcome measure."|||participants|||Number
2680186|NCT01403805|Other Pre-specified|Reject Vaccine|Number of resident to reject vaccine|These participants rejected vaccine before treatment, Day 1|"These participants were determined as Not Completed due to Reject vaccine. We excluded these participants from analysis for outcome measure."|||participants|||Number
2680187|NCT01403805|Other Pre-specified|Reject Oral Care|Number of resident to reject oral care|This participant rejected oral care before treatment, Day 1|"This participant was determined as Not Completed due to Reject oral care. We excluded this participant from analysis for outcome measure."|||participants|||Number
2680322|NCT01402115|Primary|Changes in OSC(Osteocalcin)|OSC(Osteocalcin) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||ng/mL||Standard Deviation|Mean
2680188|NCT01403805|Other Pre-specified|Leaving Nursing Home|Numer of resident for leaving nursing home|These participants were followed for the duration of nursing home stay, an average of 22 weeks.|"These participants were determined as Not Completed due to Leaving nursing home. We excluded these participants from analysis for outcome measure."|||participants|||Number
2680189|NCT01403805|Secondary|Death From Pneumonia|Number of participants for the death from pneumonia|1 year||||participants|||Number
2680190|NCT01403805|Primary|Number of Participants With Pneumonia|Number of Participants with Pneumonia sufferers|1 year||||participants|||Number
2680191|NCT01403610|Primary|Time to Progression|Time from initiation study until radiographic progression by RANO criteria|2 years|See full published data at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6071657/|||months||Full Range|Median
2680192|NCT01403441|Secondary|Delis-Kaplan Executive Function System (D-KEFS) Composite Score|D-KEFS is a neurocognitive assessment of executive function. The composite score is derived from scores on tests that include Trails A, Color Word Interference, Verbal Fluency, Sorting, WAIS III Digit Span, and CVLT II Long Delay Free Recall. The scores are reported as deviation from a mean of 10, with a standard deviation of 3. A score of 7 is one standard deviation below the mean, while a score of 13 is 1 standard deviation above the mean. Higher numeric outcomes reflect better performance on the test, lower values reflect poorer performance. Results reflect scores at baseline, and 12 month observation period following Cyberknife System|Baseline and 12 months||||units on a scale||Standard Deviation|Mean
2680193|NCT01403441|Secondary|Clinical Global Impression - Severity (CGI-S) at Baseline and 12 Months|The CGI-S assess the overall severity of depression over the 12 month observation period following Cyberknife System. It is rated from 1 (well or remitted) to 7 (severely ill, among the most depressed).|Baseline and 12 months||||units on a scale||Standard Deviation|Mean
2680194|NCT01403441|Secondary|Hamilton Depression Rating Scale (HDRS) - 17 Item|The HDRS is a rating scale measures the severity of depressive symptoms. The scale consists of 17 symptoms with severity anchors that are scored from 0 to 4. The maximum score (most severe depression) is 68, the lowest (no depressive symptoms) is 0.|Baseline and 12 months|Patients with Bipolar disorder in the depressive phase that have not responded to available treatments|||units on a scale||Standard Deviation|Mean
2680195|NCT01403441|Primary|Serious Adverse Event|An event that required hospitalization due to an unanticipated worsening of the subjects bipolar disorder.|Baseline and 12 months.|Patients with bipolar disorder in the depressive phase who have not responded to any available treatment|||event|||Number
2680196|NCT01403376|Secondary|Immunoglobulin Levels||pre vaccination (baseline) and 28 days post vaccination|Per-protocol population as previously defined|||g/L||Standard Deviation|Mean
2680197|NCT01403376|Secondary|Geometric Mean of Titers (GMT) Ratio Post/Pre Vaccination||pre vaccination (baseline) and 28 days post vaccination|Per-protocol population as previously defined|||ratio post/pre vaccination||90% Confidence Interval|Geometric Mean
2680198|NCT01403376|Secondary|Percentage of Participants With 4 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination|Percentages of participants with an increase from baseline of 4-fold or more in antibody titers and 90% CIs using normal approximation were calculated for each strain and treatment group.|pre vaccination (baseline) and 28 days post vaccination|Per-protocol population as previously defined|||percentage of participants||90% Confidence Interval|Number
2680199|NCT01403376|Secondary|Percentage of Participants With 2 Fold or More Increase in Antibody Titer at 28 Days Post Vaccination|Percentages of participants with an increase from baseline of 2-fold or more in antibody titers and 90% CIs using normal approximation were calculated for each strain and treatment group.|pre vaccination (baseline) and 28 days post vaccination|Per-protocol population as previously defined|||percentage of participants||90% Confidence Interval|Number
2680200|NCT01403376|Primary|Percentage of Participants With Antibody Titer ≥40 at 28 Days Post Vaccination|"For each viral strain (H1N1, H3N2, and B), the antibody titer, level of antibodies in blood sample when exposed to antigen, was calculated as the mean of two replicates. If the titer was below or above the limit of detection, the threshold value was used.~The percentage of participants achieving a titer of 40 or more, as well as the 90% confidence interval (CI) using normal approximation were calculated for each strain and treatment group."|28 days post vaccination|Per-protocol population: Enrolled and vaccinated participants with antibody assessments at Day 28, but excluding those with important events/deviations potentially impacting analysis (multiple sclerosis relapse, poor compliance to treatment, interfering concomitant drug). Participants were considered according to the treatment actually received.|||percentage of participants||90% Confidence Interval|Number
2680201|NCT01403246|Primary|Number of Dose Limiting Toxic Events (DLT) of Lenalidomide Given in Combination With Chlorambucil.||At maximum 8 months from induction therapy start||||Toxic events|||Number
2680202|NCT01403194|Secondary|Change in Level of Lipids||baseline, 3 months|Only one participant returned for the 3 month visit.||||||
2680203|NCT01403194|Secondary|Change in Level of Fasting Insulin||baseline, 3 months|Only one participant returned for the 3 month visit.||||||
2680204|NCT01403194|Primary|Change in Level of Fasting Glucose||baseline, 3 months|Only one participant returned for the 3 month visit.||||||
2680205|NCT01403116|Secondary|% of Oral TU Subjects With 24-hour Maximum Serum T Concentrations (Cmax) Greater Than 1500 ng/dL on Day 90|Percentage of Oral TU treated patients who reached study day 90 and had a maximum serum T concentrations (Cmax) values greater than 1500 ng/dL(objective to meet <15%).|90 days|Percent of oral TU treated subjects with Cmax >1500 ng/dL at Study Day 90|||Participants|||Count of Participants
2680206|NCT01403116|Primary|Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL|The percentages of treated subjects that had 24-hour serum testosterone (T) average concentrations (Cavg) between 300 and 1000 ng/dL|Following 90 days of treatment|Intent to treat population|||percentage of partipants||95% Confidence Interval|Geometric Mean
2680207|NCT01403090|Primary|Safety|Device safety was evaluated on the basis of identification and summarization of the incidence rates of complications and adverse effects.|30 days||||participants|||Number
2680323|NCT01402115|Primary|Changes in DPD(Deoxypyridinoline)|DPD(Deoxypyridinoline) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||nanoMolar DPD per milliMolar creatine||Standard Deviation|Mean
2680208|NCT01403051|Secondary|The Changes From Baseline in iPTH to Weeks 24 and 48|iPTH (Parathyroid Hormone, intact) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=72 and 77 for changes at week 24, n=66 and 72 for changes at week 48."|||pg/mL||Inter-Quartile Range|Median
2680209|NCT01403051|Secondary|The Changes From Baseline in CD4 to Weeks 4, 12, 24 and 48|Total CD4 count changes from baseline to weeks 4, 12, 24 and 48 [week 4/12/24/48 - baseline].|Weeks 0, 4, 12, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=78 and 86 for changes at week 4, n=77 and 85 for changes at week 4, n=76 and 84 for changes at week 24, n=69 and 80 for changes at week 48."|||cells/mm^3||Inter-Quartile Range|Median
2680210|NCT01403051|Secondary|The Changes From Baseline in Urinary Phosphate Excretion to Weeks 24 and 48|"Fractional excretion of phosphate changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).~Fractional Excretion of Phosphate (in %) is defined as:~[Urine Phosphate x Serum Creatinine] / [Urine Creatinine x Serum Phosphate] x 100%"|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=58 and 70 for changes at week 24, n=59 and 69 for changes at week 48."|||percent||Inter-Quartile Range|Median
2680211|NCT01403051|Secondary|The Changes From Baseline in Fasting LDL to Weeks 24 and 48|Fasting LDL cholesterol changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=70 and 72 for changes at week 24, n=65 and 67 for changes at week 48."|||mg/dL||Inter-Quartile Range|Median
2680212|NCT01403051|Secondary|The Changes From Baseline in Fasting Total Cholesterol to Weeks 24 and 48|Fasting total cholesterol changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=74 and 80 for changes at week 24, n=68 and 73 for changes at week 48."|||mg/dL||Inter-Quartile Range|Median
2680213|NCT01403051|Secondary|The Changes From Baseline in HOMA-IR to Weeks 24 and 48|Homeostatic model assessment insulin resistance (HOMA-IR) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=69 and 73 for changes at week 24, n=64 and 69 for changes at week 48."|||HOMA-IR||Inter-Quartile Range|Median
2680214|NCT01403051|Secondary|The Changes From Baseline in CTX to Weeks 24 and 48|CTX (marker of bone resorption) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=72 and 77 for changes at week 24, n=66 and 72 for changes at week 48."|||ng/mL||Inter-Quartile Range|Median
2680215|NCT01403051|Secondary|The Changes From Baseline in P1NP to Weeks 24 and 48|P1NP (marker of bone formation) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=72 and 77 for changes at week 24, n=66 and 72 for changes at week 48."|||ng/mL||Inter-Quartile Range|Median
2680216|NCT01403051|Secondary|The Changes From Baseline in sCD14 to Weeks 24 and 48|Soluble cluster of differentiation 14 (sCD14) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=68 and 68 for changes at week 24, n=62 and 63 for changes at week 48."|||log10 ng/mL||Inter-Quartile Range|Median
2680217|NCT01403051|Secondary|The Changes From Baseline in IL-6 to Weeks 24 and 48|Interleukin 6 (IL-6) changes from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).|Weeks 0, 24 and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=66 and 68 for changes at week 24, n=58 and 62 for changes at week 48."|||log10 pg/mL||Inter-Quartile Range|Median
2680218|NCT01403051|Secondary|The Change in Total 25-OH Vitamin D Level From Baseline to Weeks 24 and 48|"Changes in total 25-OH vitamin D from baseline to weeks 24 and 48 ( [week 24-baseline] and [week 48 - baseline], respectively).~Total 25-OH vitamin D is the sum of vitamin 25-OH D2 and D3 levels. All 25-OH vitamin D2 or D3 values below the lower limit of 1.25 ng/mL were imputed to 0 ng/mL"|Weeks 0, 24, and 48|"Included all available data regardless of treatment change/discontinuation, but was limited to eligible subjects who had both baseline and follow-up data.~n=71 and 74 for changes at week 24, n=65 and 68 for changes at week 48."|||ng/mL||Inter-Quartile Range|Median
2680219|NCT01403051|Secondary|Number of Participants With Primary Adverse Events|Primary adverse events include all SAEs defined according to ICH guidelines and targeted protocol events, which include all diagnoses of hypercalcemia, hypophoatemia, and nephrolithiasis as well as signs and symptoms grade 2 or higher that may be associated with hypercalcemia and all laboratory toxicities grade 2 or higher defined by the 2004 DAIDS grading table|From first study treatment to week 48|All enrolled subjects including subjects excluded from efficacy analysis due to eligibility violation.|||participants|||Number
2680220|NCT01403051|Secondary|The Percent Change From Baseline in Bone Mineral Density (BMD) at Spine|The percent change from baseline to week 48 in bone mineral density (BMD) at spine as measured by DXA scan|Weeks 0 and 48|This analysis is intent-to-treat (ITT) which is limited to eligible subjects who have baseline and week 48 follow-up regardless of treatment change or discontinuation.|||percentage change||Inter-Quartile Range|Median
2680221|NCT01403051|Primary|The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip|The efficacy endpoint is the percent change from baseline to week 48 in bone mineral density (BMD) at total hip (as measured by DXA scan)|Weeks 0 and 48|The primary analysis is intent-to-treat (ITT) which is limited to eligible subjects who have baseline and week 48 follow-up regardless of treatment change or discontinuation.|||percentage change||Inter-Quartile Range|Median
2680222|NCT01402986|Secondary|Percent Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home|The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percentage change||Standard Error|Mean
2680223|NCT01402986|Secondary|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home|Pre- and post-bronchodilator FEV1 at home (morning and evening) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percentage change||Standard Error|Mean
2680224|NCT01402986|Secondary|Percent Change From Baseline in Inspiratory Capacity (IC) at Week 53|Pre- and post-bronchodilator IC at clinic visits (morning) were measured. IC was measured by spirometry. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms. Baseline for IC was measured in liters.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percentage change in liters||Standard Error|Mean
2680225|NCT01402986|Secondary|Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 53|Pre- and post-bronchodilator FVC at clinic visits (morning) were measured. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms. Baseline for FVC was measured in liters.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percentage change in liters||Standard Error|Mean
2680226|NCT01402986|Secondary|Percent Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53|Pre- and post-bronchodilator FEV6 at clinic visits (morning) were measured. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms. Baseline for FEV6 was measured in liters.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percentage change in liters||Standard Error|Mean
2680227|NCT01402986|Secondary|Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53|Pre- and post-bronchodilator FEV1 at clinic visits (morning) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms. Baseline for FEV1 was measured in liters.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percentage change in liters||Standard Error|Mean
2680228|NCT01402986|Secondary|Change From Baseline in Overall Activity Limitations at Week 53|There were 3 activity limitation questions in the ASMA diary. All activity questions were scored from 0 to 4 and averaged, where the higher score indicated greater limitation. Activity limitation scores were averaged weekly for participants with at least 4 non-missing records each week. The baseline score was calculated from Day -7 to Day -1. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2680229|NCT01402986|Secondary|Change From Baseline in Percentage of Nighttime Awakening at Week 53|Scores for nighttime awakenings were generated based on the single item (question 5) that had a dichotomous response option (YES/NO). Nighttime awakenings were averaged weekly for participants with at least 4 non-missing records each week. The baseline score was calculated with data from Day -7 to Day -1. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percentage change||Standard Deviation|Mean
2680230|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Chronic OCS Use|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup chronic OCS use. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
2680262|NCT01402986|Secondary|Mean Change From Baseline in Forced Expiratory Volume in 6 Second (FEV6) at Week 53|Pre- and post-bronchodilator FEV6 at clinic visits (morning) were measured. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||liters||Standard Error|Mean
2680231|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Atopic Asthma Status|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. AER was evaluated by subgroup Atopic and Non-atopic asthma status. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
2680232|NCT01402986|Secondary|Change From Baseline in Total AQLQ(S) Scores at Week 53 in Subgroups|AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
2680233|NCT01402986|Secondary|Change From Baseline in Mean ACQ-6 Scores at Week 53 in Subgroups|Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
2680234|NCT01402986|Secondary|Percent Change From Baseline in Prebronchodilator FEV1 at Week 53 in Subgroups|Prebronchodilator FEV1 was evaluated by subgroups. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||Percent change||Standard Error|Mean
2680235|NCT01402986|Secondary|Severe Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count|Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER was evaluated by subgroup baseline peripheral blood eosinophil count. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
2680236|NCT01402986|Secondary|Severe Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status|Severe AER was assessed based on AER data up to Week 53. An asthma exacerbation is a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 days. It was considered resolved 7 days after last dose of OCS administered (10 days after injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER was evaluated by subgroup Th2 status. Th2-high include participants who had IgE >100 IU/mL and blood eosinophils >=0.14*10^9/Liter. Th2 low would include participants who do not meet Th2 high status. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
2680237|NCT01402986|Secondary|Severe Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility|Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER was evaluated by subgroup FEV1 reversibility. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
2680238|NCT01402986|Secondary|Severe Asthma Exacerbation Rate (AER) by Baseline Serum Periostin|Severe AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Severe AER evaluated by subgroup baseline serum periostin. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
2680239|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Asthma Exacerbations in the Past Year|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup as asthma exacerbations in the past year. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
2680240|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Baseline FEV1% Predicted|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER was evaluated by subgroup baseline FEV1% predicaed. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
2680241|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Baseline FEV1 Reversibility|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroup baseline FEV1 reversibility >=12% and <12%. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
2680242|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Baseline Peripheral Blood Eosinophil Count|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER evaluated by subgroups baseline peripheral blood eosinophil counts. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
2680243|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by T-helper-2 (Th2) Status|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. AER was evaluated by subgroup Th2 status. Th2-high included those participants who had immunoglobulin E (IgE) >100 international unit per milliliter (IU/mL) and blood eosinophils >= 0.14 * 10 power 9 per Liter. Th2 low would include those participants who do not meet Th2 high status. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
2680244|NCT01402986|Secondary|Annual Asthma Exacerbation Rate (AER) by Baseline Serum Periostin|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. It was considered resolved 7 days after the last dose of OCS administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. AER was evaluated by subgroup baseline serum periostin greater than or equal to (>=) or less than (<) median, >= or < 25th percentile and >= or < 75th percentile. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 1 up to Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||AER events/person-year||95% Confidence Interval|Number
2680245|NCT01402986|Secondary|Time to First Severe Exacerbation Through Week 53|Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 1 up to Week 53|The ITT population included all participants who were randomized into the study.|||days||95% Confidence Interval|Median
2680246|NCT01402986|Secondary|Time to First Exacerbation Through Week 53|Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 1 up to Week 53|The ITT population included all participants who were randomized into the study.|||days||95% Confidence Interval|Median
2680247|NCT01402986|Secondary|Severe Annual Asthma Exacerbation Rate (AER)|Severe annualized AER was assessed based on AER data up to Week 53. Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed or administered by the investigator; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. An asthma exacerbation event was considered resolved 7 days after the last dose of oral corticosteroids is administered (10 days after an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 1 up to Week 53|The ITT population included all participants who were randomized into the study.|||AER events/person-year||95% Confidence Interval|Number
2680248|NCT01402986|Secondary|Percentage of Participants With Anti-Drug Antibodies (ADA) to Tralokinumab|Immunogenicity assessment included determination of anti-drug (tralokinumab) antibodies in serum samples. ADA positive was defined as a titer greater than or equal to (>=13) at any point in the study. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Baseline and Week 75|"The PK population included all participants who received at least one dose of tralokinumab and had at least one quantifiable PK observation. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percentage of participants|||Number
2680249|NCT01402986|Secondary|Observed Serum Tralokinumab Concentration at Week 53|Tralokinumab concentrations that were below limit of quantification (LOQ) of the pharmacokinetic (PK) assay (LOQ = 0.500 microgram per milliliter [mcg/mL]) were replaced by LOQ/2 = 0.250 mcg/mL; results were reported to 3 significant figures level of precision. Observed serum tralokinumab concentration at Week 53 was reported.|Week 53|"The PK population included all participants who received at least one dose of tralokinumab and had at least one quantifiable PK observation. Here N signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||microgram per milliliter||Standard Deviation|Mean
2680250|NCT01402986|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to Week 75 that were absent before treatment or that worsened relative to pre-treatment state. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Baseline and Week 75|The safety population included all participants who received any investigational product and had safety data available for analysis.|||participants|||Number
2680251|NCT01402986|Secondary|Change From Baseline in Rescue Medication Use at Week 53|Rescue medication use was collected from 3 questions: daytime use in response to symptoms (question 3), daytime prophylactic use (question 4) and nighttime use (question 7). Rescue medication use questions were first assessed using a dichotomous response option (YES/NO). If the participants reported YES, there was a subsequent question about the number of times rescue medication was used (questions 3a, 4a, and 7a). Daily average scores were summarized each week for all participants with at least 4 non-missing records each week. Days with no reported rescue medication use were represented as 0 and included in the calculation with participants who reported yes and completed questions 3a, 4a and 7a. The baseline scores were calculated from Day -7 to Day -1. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||use per day||Standard Deviation|Mean
2680252|NCT01402986|Secondary|Change From Baseline in Assessing Symptoms of Moderate-to-severe Asthma (ASMA) at Week 53|There were 3 symptom questions in the ASMA diary: daytime frequency (question 1), daytime severity (question 2) and nighttime severity (question 6). All symptom questions were scored from 0 to 4 averaged, where a higher score indicated greater frequency or severity. Daily Asthma symptom scores were averaged weekly for participants with at least 4 non-missing records each week. The baseline score was calculated from Day -7 to Day -1. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Day -7 - Day -1 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Deviation|Mean
2680253|NCT01402986|Secondary|Change From Baseline in European Quality of Life 5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Week 53|The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The EQ-5D VAS was measured from 0 (worst imaginable health state) to 100 (best imaginable health state). Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
2680254|NCT01402986|Secondary|Number of Participants With European Quality of Life 5 Dimensions (EQ-5D) Scores at Week 53|The utility-based EQ-5D questionnaire comprises of two parts and provides a generic measure of health for clinical and economic appraisal. The health state valuation was the summary score of mobility, self-care, usual activities, pain/discomfort and anxiety/depression on a 3 category scale (no problem, moderate problem, severe problems) that reflects increasing levels of difficulty. The minimum possible value is 5 (one point for each dimension) and the maximum possible values is 15 (3 points for each dimension). Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 53|The ITT population included all participants who were randomized into the study.|||participants|||Number
2680255|NCT01402986|Secondary|Change From Baseline in Asthma Quality of Life Questionnaire Standardized Version (AQLQ[S]) Score at Week 53|AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
2680256|NCT01402986|Secondary|Change From Baseline in Mean Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 53|Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score was the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||units on a scale||Standard Error|Mean
2680257|NCT01402986|Secondary|Mean Change From Baseline in Peak Expiratory Flow (PEF) at Week 53 at Home|The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||liters per minute||Standard Error|Mean
2680258|NCT01402986|Secondary|Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53 at Home|Pre- and post-bronchodilator FEV1 at home (morning and evening) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Day 1 - Day 7 (Baseline) and Day 365 - Day 371 (Week 53)|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||liters||Standard Error|Mean
2680259|NCT01402986|Secondary|Mean Change From Baseline in Inspiratory Capacity (IC) at Week 53|Pre- and post-bronchodilator IC at clinic visits (morning) were measured. IC was measured by spirometry. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||liters||Standard Error|Mean
2680260|NCT01402986|Secondary|Mean Change From Baseline in Ratio of Forced Expiratory Volume in 1 Second (FEV1)/Forced Vital Capacity (FVC) at Week 53|Pre- and post-bronchodilator FEV1 and FVC at clinic visits (morning) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Ratio of FEV1/FVC was analysed. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||percentage of ratio||Standard Error|Mean
2680261|NCT01402986|Secondary|Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 53|Pre- and post-bronchodilator FVC at clinic visits (morning) were measured. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||liters||Standard Error|Mean
2680276|NCT01402570|Primary|PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning|Ability to carry out activities that require physical actions, ranging from self-care (activities of daily living) to more complex activities that require a combination of skills, often within a social context. Scores are standardized T-scores with mean of 50 and standard deviation of 10; higher scores indicate better physical function.|Baseline, 1 month, 2 months and 3 months||||units on a scale||Standard Deviation|Mean
2680263|NCT01402986|Secondary|Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 53|Pre- and post-bronchodilator FEV1 at clinic visits (morning) were measured. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Baseline and Week 53|"The ITT population included all participants who were randomized into the study. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively."|||liters||Standard Error|Mean
2680264|NCT01402986|Primary|Annual Asthma Exacerbation Rate (AER)|Annualized AER was assessed based on AER data up to Week 53. An asthma exacerbation defined as a progressive increase of asthma symptoms that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 consecutive days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids for a duration of at least 3 consecutive days. An asthma exacerbation event was considered resolved 7 days after the last dose of oral corticosteroids (OCS) is administered (10 days after administration of an injectable corticosteroid). Courses of corticosteroids initiated after this time period were considered a separate new asthma exacerbation. Data were summarized together for 'Placebo, Q2W' and 'Placebo, Q2/4W' arms.|Week 1 up to Week 53|The intent-to-treat (ITT) population included all participants who were randomized into the study.|||AER events/person-year||95% Confidence Interval|Number
2680265|NCT01402947|Primary|Maximum Plasma Concentration (Cmax) of Ciprofloxacin XR|Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.|||ng/ml||Standard Deviation|Mean
2680266|NCT01402947|Primary|Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Ciprofloxacin XR|AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.|Assessed over a 24-hour period starting post-dose on day 4|Pharmacokinetic Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Analysis Set defined as subjects who took at least 1 dose of investigational product and had at least 1 postdose safety assessment.|||ng*h/ml||Standard Deviation|Mean
2680267|NCT01402869|Secondary|Delta Methemoglobin Blood Level|Change in percentage of methemoglobin in blood from baseline level to peak level|From administration of local anesthetic or start of restorative procedures to time at which maximum methemoglobin blood level was documented during dental treatment for an average of 2 hours|Per protocol|||percentage of methemoglobin in blood||Standard Deviation|Mean
2680268|NCT01402869|Secondary|Time to Peak Methemoglobin Blood Levels|The length of time between the administration of local anesthetic (Prilocaine and Lidocaine Groups) or start of restorative dental procedures (No local anesthetic Group) and the time at which the maximum methemoglobin blood level is observed.|Measured at 10 second intervals during dental treatment for an average of 2 hours|per protocol|||minutes||Standard Deviation|Mean
2680269|NCT01402869|Primary|Peak Methemoglobin Blood Levels|The maximum percentage of methemoglobin in blood|Measured at 10 second intervals during dental treatment for an average of 2 hours|Per protocol|||percentage of methemoglobin in blood||Standard Deviation|Mean
2680270|NCT01402817|Secondary|Volumetric Disease Evaluation|To determine the response rate with Sutent® in patients with plexiform neurofibromas using volumetric analysis of MRI scans|6 months||||percentage of subjects|||Number
2680271|NCT01402817|Primary|Disease Response|To estimate the disease control rate (SD, PR, CR) with Sutent® in patients with neurofibromas (NF1). Tumor response criteria are determined by changes in size using all 3 dimensional measurements: width (W), transvers (T) , and length (L) measurements. Partial Response: ≥20% decrease in the sum of the products of the three perpendicular diameters of all target lesions (up to 5), taking as reference the initial baseline measurements.Stable Disease (SD): Neither sufficient decrease in the sum of the products of the three perpendicular diameters of all target lesions to qualify for PR (taking as reference the initial baseline measurements), nor sufficient increase in a single target lesions to qualify for PD, (taking as reference the smallest disease measurement since the treatment started).Progressive Disease (PD): 40% or more increase in the product of perpendicular diameters of ANY target lesion, taking as reference the smallest product observed.|6 months||||percentage of subjects||95% Confidence Interval|Number
2680272|NCT01402700|Primary|Major Adverse Event Rate at 9 Months|The Major Adverse Event rate at 9 months is defined as a composite of periprocedural death, in-hospital MI, clinically-driven target lesion revascularization and amputation of the treated limb through 9 months postprocedure.|9 months||||percentage of participants|||Number
2680273|NCT01402570|Primary|PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue|Assesses fatigue from mild subjective feelings to an overwhelming, debilitating, and sustained sense of exhaustion that is likely to decrease one's ability to carry out daily activities, including the ability to work effectively and to function at one's usual level in family or social roles. Fatigue is divided conceptually into the experience of fatigue (e.g., frequency, duration, and intensity), and the impact of fatigue upon physical, mental and social activities. Scores are on a T-metric with mean of 50 and standard deviation of 10; higher scores indicate greater fatigue.|Baseline, 1 month, 2 months and 3 months||||units on a scale||Standard Deviation|Mean
2680274|NCT01402570|Primary|Steps Per Day|Count of steps per day using activity monitor worn on upper arm.|Baseline, 1 month, 2 months and 3 months||||steps per day||Standard Deviation|Mean
2680275|NCT01402570|Primary|Sleep Efficiency|The ratio of time asleep over time in bed gathered from sleep diaries completed at bedtime and at awakening. Scores range from 0 to 100%, higher values indicate better sleep efficiency or more time sleeping in bed.|Baseline, 1 month, 2 months and 3 months||||units on a scale||Standard Deviation|Mean
2680313|NCT01402128|Secondary|Changes in Triglyceride|Triglyceride was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||mg/dL||Standard Deviation|Mean
2680277|NCT01402544|Secondary|Mean Change in Central Foveal Thickness (CFT) From Baseline to 6 Months and Baseline to 12 Months||Baseline, Month 6 and Month 12|PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here.The CFT image for one participant could not be located, so only 5 of the 6 enrolled participants data are being reported.|||microns||Standard Deviation|Mean
2680278|NCT01402544|Secondary|Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to 6 Months and Baseline to 12 Months.|Mean change was measured by letters gained or lost. A positive number is letters gained, and a negative number is letters lost.|Baseline, Month 6 and Month 12|PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here.|||letters||Standard Deviation|Mean
2680279|NCT01402544|Primary|Number of Patients That Achieve Their Pre-wet Age-Related Macular Degeneration (AMD) Baseline Visual Acuity Within 12 Months|PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here.|Baseline, Month 6 and Month 12|PI is no longer affiliated with institution. All efforts were exhausted to obtain data from all sites for this study, but we only have access to data from UCSD site. Data from these participants is being reported here.|||Participants|||Count of Participants
2680280|NCT01402531|Primary|Epistaxis Using the Epistaxis Severity Score, Hematocrit, Hemoglobin and Serum Feritin Levels..|The Investigator of this study passed away and we do not have the study data to upload the results.|2 years|The Investigator of this study passed away and we do not have the study data to upload the results.||||||
2680281|NCT01402427|Secondary|Subjective Pain|Analysis of the rates of signiﬁcant pain deﬁned as pain score ≥4 on a semiquantitative scale ranging from 1 to 6.|Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention.||||participants|||Number
2680282|NCT01402427|Secondary|Contrast Volume||The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention.||||milliliter||Inter-Quartile Range|Median
2680283|NCT01402427|Secondary|Fluoroscopic Time||Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.||||minutes||Inter-Quartile Range|Median
2680284|NCT01402427|Secondary|Procedural Time||Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.||||minutes||Inter-Quartile Range|Median
2680285|NCT01402427|Secondary|Rate of Vasodilator Use||Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.||||participants|||Number
2680286|NCT01402427|Secondary|Rate of Code Breaks|Code break: a composite of access site conversion and unplanned use of vasodilators.|Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention.||||participants|||Number
2680287|NCT01402427|Primary|Rate of Access Site Conversions||Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.||||participants|||Number
2680288|NCT01402375|Post-Hoc|Time to Follow up|Median time to contact patients for data collection, measured from discharge to time contacted|up to 48 hours||||hours||Inter-Quartile Range|Median
2680289|NCT01402375|Post-Hoc|50% or Greater Decrease in Numerical Rating Scale (NRS) Pain Score||2 hours||||Participants|||Count of Participants
2680290|NCT01402375|Secondary|Overall Satisfaction With the Pain Medicine|Overall satisfaction with the oral opioid pain medication at 24 hours after discharge using a Likert scale. Patients will be asked to describe their overall experience as being very satisfied, satisfied, unsatisfied or very unsatisfied with the study medication.|24 hrs|Any number analyzed that does not equal the overall number of participants is due to missing data|||Participants|||Count of Participants
2680291|NCT01402375|Primary|Difference in Pain Intensity Score Before and After Last Dose.|"Pain intensity is measured on the numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable). The difference in pain score is calculated by subtracting the average score 2 hours after pain medication is taken from the average pain score immediately before the pain medication is taken."|2 hrs||||units on a scale||Standard Deviation|Mean
2680292|NCT01402284|Secondary|Complete Response (CR) and Minimal Residual Disease Neg (MRDneg) CR Rates at Treatment Intervals With Carfilzomib, Lenalidomide & Dexamethasone (CRd) in New Multiple Myeloma Patients After 8 Cycles of Induction, 1 Year Maintenance, and 2 Years Maintenance|Response is assessed by the International Myeloma Working Group Criteria. MRD is defined by M-spike, plasma cell burden, and abnormal free light chains (FLC). Complete response is negative immunofixation on serum, and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow. Stringent complete response (sCR) is normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence. Near complete response (nCR) is the absence of myeloma protein on electrophoresis, independent of immunofixation status. Very good partial response (VGPR) is serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24h. Overall response rate (ORR) is patients who attained a partial response (PR) (≥50% reduction of serum M-protein and reduction in 24h urinary M-protein) or better (BoR) response.|up to 2 years|*Six patients withdrew from the study, four due to non-compliance and two to continue treatment at another institution. `One patient refused to have a bone marrow biopsy procedure and one patient withdrew due to non-compliance. CR (n=0) after 8 cycles.|||percentage of participants||95% Confidence Interval|Number
2680293|NCT01402284|Secondary|Rate of Minimal Residual Disease (MRD) by Flow Cytometry|Response is assessed by the International Myeloma Working Group Criteria. Complete response is negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow. MRD is defined by M-spike, plasma cell burden, and abnormal free light chains. Immunophenotyping is performed by multi-parametric flow cytometry.|Day 100||||percentage of participants||95% Confidence Interval|Number
2680314|NCT01402128|Secondary|Changes in Total Cholesterol|Total cholesterol was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||mg/dL||Standard Deviation|Mean
2686922|NCT01346397|Primary|Patient Survival|in cyclosporine group 96.4 +/- 2.8%; in tacrolimus group 96.3 +/- 3.4%|5 years||||percentage of participants||95% Confidence Interval|Number
2680294|NCT01402284|Secondary|Cluster of Differentiation 138 (CD138) + Plasma Cells Gene Expression Profiling on Pre and Post Carfilzomib Exposure Bone Marrow Samples|Cluster of differentiation 138+ (CD138)+ plasma cells purified from bone marrow aspirates to identify potential markers of early progression. Changes in selected genes were confirmed by quantitative polymerase chain reaction (PCR) if suggested to be related to risk of progression to multiple myeloma.|Cycle 1 Day 1, an average of 28 days ± 2 days|Data were not collected due to lack of financial resources.||||||
2680295|NCT01402284|Secondary|Overall Survival (OS) Rate|OS is defined as the time of start of treatment to death from any cause.|up to 6 months||||percentage of participants||95% Confidence Interval|Number
2680296|NCT01402284|Secondary|Percentage of Responders With Duration of Response (DOR) at 48 Months|Response is assessed by the International Myeloma Working Group Criteria. DOR is measured from the time measurement criteria are met for a partial response or better until first date that recurrent or progressive disease is objectively documented. Partial response is ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200mg per 24h. Progressive disease requires any one or more of the following: increase of ≥25% from lowest response value in the following on 2 consecutive measurements: serum M-component and/or (the absolute increase must be ≥0.5g/dl). Urine M-component and/or (the absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels. The absolute increase must be >10mg/dl. Bone marrow plasma cell percentage: the absolute % must be ≥10%.|48 months||||percentage of participants||95% Confidence Interval|Number
2680297|NCT01402284|Secondary|Progression Free Survival (PFS) at 48 Months|PFS is defined as time of start of treatment to time of progression or death, whichever occurs first. Response is assessed by the International Myeloma Working Group Criteria. Progressive disease requires any one or more of the following: increase of ≥25% from lowest response value in the following on 2 consecutive measurements: serum M-component and/or (the absolute increase must be ≥0.5g/dl). Urine M-component and/or (the absolute increase must be ≥200mg/24h. Only in patients without measureable serum and urine M-protein levels: the difference between involved and uninvolved free light chain (FLC) levels. The absolute increase must be >10mg/dl. Bone marrow plasma cell percentage: the absolute % must be ≥10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder.|48 months||||percentage of participants||95% Confidence Interval|Number
2680298|NCT01402284|Secondary|Overall Response Rate|Response is assessed by the International Myeloma Working Group Criteria. Patients who attained a partial response or better (BoR) response by the end of induction. Partial response is ≥50% reduction of serum M-protein and reduction in 24h urinary M-protein.|48.3 months||||percentage of participants||95% Confidence Interval|Number
2680299|NCT01402284|Primary|Number of Participants With Serious and Non-serious Adverse Events|Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|4 years and 9 months and 2 days||||Participants|||Count of Participants
2680300|NCT01402141|Primary|Number of Participants With Greater Than 40% Decrease in Histamine-induced Wheal Size (Wheal Size by More Than 40% Decrease in the Number of Subjects Compared With Placebo)|"Number of Participants with Greater than 40% Decrease in Histamine-induced Wheal Size was measured in study visit 1(0 week) and visit 3(12 week).~Percentage change in histamine-induced wheal size calculations were calculated by the formula ((12weeks - 0weeks) * 100/0weeks).~Number of Participants with Greater than 40% Decrease in Histamine-induced Wheal Size compared with placebo."|12weeks|per protocol analysis|||participants|||Number
2680301|NCT01402141|Secondary|Changes in Eosinophil Cationic Protein(ECP)|Eosinophil Cationic Protein(ECP) was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||μg/L||Standard Deviation|Mean
2680302|NCT01402141|Secondary|Changes in Eosinophil|Eosinophil was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||Percentage of WBCs(white blood cells)||Standard Deviation|Mean
2680303|NCT01402141|Secondary|Changes in Interleukin-4|Interleukin-4 was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||pg/ml||Standard Deviation|Mean
2680304|NCT01402141|Secondary|Changes in Interferon-gamma|Interferon-gamma was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||IU/ml||Standard Deviation|Mean
2680305|NCT01402141|Secondary|Changes in Serum Histamine|Serum histamine was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||μg/g creatinine||Standard Deviation|Mean
2680306|NCT01402141|Secondary|Changes in Immunoglobulin E|Immunoglobulin E was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||IU/mL||Standard Deviation|Mean
2680307|NCT01402141|Primary|Changes in Histamine-induced Wheal Size|Histamine-induced wheal size was measured in study visit 1(0 week) and visit 3(12 week).|12weeks|per protocol analysis|||mm^2||Standard Deviation|Mean
2680308|NCT01402128|Secondary|Changes in Subcutaneous Adipose Tissue|Subcutaneous adipose tissue was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||cm^3||Standard Deviation|Mean
2680309|NCT01402128|Primary|Changes in Percent Body Fat(%)|Percent body fat(%) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||percentage of body fat||Standard Deviation|Mean
2680310|NCT01402128|Secondary|Changes in Apo-B(Apolipoprotein B)|Apo-B(Apolipoprotein B) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||g/L||Standard Deviation|Mean
2680311|NCT01402128|Secondary|Changes in Apo-A1(Apolipoprotein A1)|Apo-A1(Apolipoprotein A1) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||g/l||Standard Deviation|Mean
2680312|NCT01402128|Secondary|Changes in FFA(Free Fatty Acid)|FFA(free fatty acid) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||µEq/L||Standard Deviation|Mean
2680329|NCT01402102|Secondary|Changes in HDL-Cholesterol(High Density Lipoprotein - Cholesterol)|HDL-cholesterol(High Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|PP analysis|||mg/dl||Standard Deviation|Mean
2680330|NCT01402102|Primary|Changes in LDL-cholesterol(Low Density Lipoprotein - Cholesterol)|LDL-C(Low Density Lipoprotein - cholesterol) was measured in study visit 1(0 week) and visit 3(12 week).|12 weeks|per protocol analysis|||mg/dl||Standard Deviation|Mean
2680331|NCT01402063|Primary|Progression Free Survival PPX/RT Versus TMZ/RT for Patients With GBM Without Methylation|"MRI response evaluated by RANO criteria~Complete Response (CR): Circumstance when the enhancing tumor is no longer seen by neuroimaging, with the patient off all steroids or on adrenal maintenance only; CR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan coding a response.~Partial Response (PR): Decrease of > 50% in the product of two diameters. Patients should be receiving stable or decreasing doses of steroids. PR will be coded only if confirmed by a second CT/MR scan performed a minimum of 4 weeks after the initial scan.~Progression (P): A > 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. This will not need a confirmatory scan. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of XRT."|Q 3 months on study then Q3 months in f/u for yr 1, q 4 months yr 2, q 6 months for approximately 4 ys.||||participants|||Number
2680332|NCT01402050|Primary|Time Of Start Of Induction Of Labor To Delivery|"The primary outcome variable was time (measured in hours) from first attempt at study agent placement to delivery. Time of placement of Labor Induction agent was noted as the time of Labor Induction initiation and time of delivery was noted as the end time of Labor Induction.~There were no specific time points at which the outcomes were measured due to the uncertainty of the labor process. Total time duration of Labor induction was noted in hours.~Key word: INDUCTION OF LABOR"|Hours||||hours||Inter-Quartile Range|Median
2680333|NCT01402011|Other Pre-specified|Visual Analog Pain Scale|Subject marks his pain level at rest, at work, doing sports on a 10 cm scale. Maximum of pain scores rest, work, sport is recorded.|one month|||||||
2680334|NCT01402011|Other Pre-specified|Visual Analog Pain Scale|Subject marks his pain level at rest, at work, doing sports on a 10 cm scale.|two months|||||||
2680335|NCT01402011|Other Pre-specified|Total Prescription Pain Medication Used|Total amount of narcotic pain medication prescribed. Data were not collected at 1,2,3 and 6 months.|20 minutes before first injection on first day of patient visit|||||||
2680336|NCT01402011|Secondary|Nine Month Satisfaction Questionnaire|Phone call asking how satisfied were they with their treatment 10 = extremely satisfied, 0 = extremely dissatisfied )|Nine months after first injection treatment appointment||||units on a scale||Standard Deviation|Mean
2680337|NCT01402011|Secondary|Disabilities of the Arm Shoulder and Hand Questionnaire|http://www.dash.iwh.on.ca/assets/images/pdfs/DASH_quest06.pdf 30 questions assessing ability to use shoulder in everyday activities, each question scored 1 to 5, where one is normal, no problem and five is unable to perform. No data was collected at 9 months. The score ranges from 30 to 150. Higher scores represent worse outcomes.|20 minutes before the first injection and at 3 months||||units on a scale||Standard Deviation|Mean
2680338|NCT01402011|Secondary|Physical Examination of the Shoulder Scale|From Steven W. Brose, DO, Michael L. Boninger, MD, Bradley Fullerton, MD, Thane McCann, MD, From: Jennifer L. Collinger, BSE, Bradley G. Impink, BSE, Trevor A. Dyson-Hudson, MD Shoulder ultrasound abnormalities, physical examination findings, and pain in manual wheelchair users with spinal cord injury. Arch Phys Med Rehabil 2008 Nov; 89:2086-93, appendix 1 12 parameters of shoulder examination: Biceps tendon/bicipital groove tenderness, Supraspinatus tendon/greater tuberosity tenderness Acromioclavicular joint tenderness Resisted external rotation. Resisted internal rotation. Supraspinatus test. Painful Arc Test. Neer impingement sign. Hawkins-Kennedy impingement sign. O'Brien Active Compression Test for AC Joint Pathology O'Brien Active Compression Test for Labral Pathology impingement sign. each test scored 0 = no pain, 1 = tenderness, 2 = pain. All 12 scores added. Range 0-24. Higher scores = more pathology|20 minutes before first injection on first day of patient visit and at 3 months||||units on a scale||Standard Deviation|Mean
2680339|NCT01402011|Secondary|Rotator Cuff Ultrasound, Ultrasound Shoulder Pathology Rating Scale|"From Brose et al. shoulder ultrasound abnormalities, physical examination findings, and pain in manual wheelchair users with spinal cord injury Arch Phys Med Rehabil 2008 Nov, 89: 2086-93 appendix 2. rates biceps tendinopathy (0-6), supraspinatus tendinopathy (0-5), greater tuberosity the cortical surface (0-3), dynamics supraspinatus impingement (0-3), dynamic subscapularis/ biceps/ coracoid impingement (0-3). The total score ranged from 0 to 20 with higher scores indicating a worse outcome. The change was calculated by taking the final score - the baseline score."|20 minutes before first injection on first day of patient visit and at on average 9.4 months|Three of the 25% dextrose in ligaments and tendons group did not show up for their ultrasound appointment at nine months.|||units on a scale||Standard Deviation|Mean
2680340|NCT01402011|Primary|Change From Baseline in Maximum Pain Score at 9 Months|Participants were asked about pain at rest, at work, doing sports. The maximum pain reported on a scale ranging from 0 (no pain at all) to 10 (extreme pain) was recorded for each participant. Maximum of pain scores rest, work, sport recorded. Calculated as pain at baseline - pain at 9 months.|baseline and 9 months||||units on a scale||Standard Deviation|Mean
2680341|NCT01402011|Primary|Change From Baseline of Visual Analog Pain Scale at 3 Months|Subject marks his pain level at rest, at work, doing sports on a 10 cm scale. Maximum of pain scores rest, work, sport recorded. Calculated as pain at baseline - pain at 3 months. VAS scale is from 0 = no pain to 10 = maximum pain|baseline and three months||||units on a scale||Standard Deviation|Mean
2680342|NCT01402011|Primary|Visual Analog Pain Scale 0= no Pain 10 = Maximum Pain|Subject marks his pain level at rest, at work, doing sports on a 10 cm scale. The maximum pain level among the 3 different activities was recorded.|20 minutes before first injection on first day of patient visit||||units on a scale||Standard Deviation|Mean
2680369|NCT01401582|Secondary|Person With Dementia: Change in Utilization of Health Care Resources|"frequency of utilisation of~general physicians and physicians of other specialties~out-patient treatments~in-patient treatments~hospitalisations~institutionalisation~therapeutic appliances~standardised assessment with the Resource Utilization in Dementia (RUD, Wimo et al. 1998)."|participants will be followed yearly until institutionalisation or death after an expected average of 5 years||2020-05-31|05/2020||||
2680343|NCT01401959|Secondary|The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of Safety|A treatment-related adverse event or serious adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator's assessment). Adverse events and serious adverse events will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V4.03.|Weekly during each 21 day cycle and for 30 days after completion of protocol-specific treatment. After that patients were followed every 3 months for up to 2 years.|All patients who receive at least one dose of treatment.|||Participants|||Count of Participants
2680344|NCT01401959|Secondary|Number of Patients Who Completed Eribulin Therapy as an Assessment of Treatment Feasibility|Examines the feasibility of administering 6 cycles (21 days per cycle) of eribulin without toxicity or disease worsening following standard neoadjuvant chemotherapy and surgery.|up to 18 weeks|All patients who received at least one dose of treatment|||Participants|||Count of Participants
2680345|NCT01401959|Primary|Percentage of Patients With a 2 Year Disease-Free Survival (DFS) as a Measure of Efficacy|The percentage of patients that are without evidence of disease recurrence at the 2 year timepoint, as measured from date of first protocol treatment date to first documented disease progression date or date of death from any cause, whichever comes first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 2 years|Patients who receive at least one dose of treatment|||percentage of patients||95% Confidence Interval|Number
2680346|NCT01401907|Other Pre-specified|Survival||from date of randomization until date of death, assessed up to 3 years||2019-12-31|12/2019||||
2680347|NCT01401907|Other Pre-specified|Additional Resource Utilization|hospital admissions, hospice utilization emergency room admissions intensive care unit admissions resuscitation attempt|from date of randomization until date of death, assessed up to 3 years||2019-12-31|12/2019||||
2680348|NCT01401907|Secondary|Coping (Brief Cope)|compare coping between study arms|Week-12 and Week-24|||||||
2680349|NCT01401907|Secondary|Code Status Documentation|examine rates and timing of code status documentation|study participants will be followed until death or for a minimum of 2 years after enrollment||2019-12-31|12/2019||||
2680350|NCT01401907|Secondary|Health Care Costs||study participants will be followed until death or for a minimum of 2 years after enrollment||2019-12-31|12/2019||||
2680351|NCT01401907|Secondary|Resource Utilization at the End of Life (EOL)|chemotherapy utilization at the EOL hospice utilization (enrollment rate and length of stay)|study participants will be followed until death or for a minimum of 2 years after enrollment||2019-12-31|12/2019||||
2680352|NCT01401907|Secondary|Number and Percentage of Family Caregivers Who Reported the Goal of Treatment is to Cure Cancer|We used the response to an item on Perception of Treatment and Prognosis Questionnaire to compare rates of accurate prognostic understanding between study arms. Family caregivers reported their primary goal of the current cancer treatment: 1) to cure my cancer; 2) to lesson my suffering as much as possible; 3) for me and/or my family to be able to keep hoping; 4) to make sure I have done everything; 5) to extend my life as long as possible; 6) to help cancer research. Family caregivers' responses were dichotomized as 1) to cure my cancer vs. all other.|12 and 24 weeks|Proportion of caregiver goal is cure at week-12 and week-24. Please note the number of participants reflect those who completed the Perception of Treatment and Prognosis Questionnaire at week-12 and week-24, which explains the discrepancy with the participants flow.|||Participants|||Count of Participants
2680353|NCT01401907|Secondary|Family Caregiver Psychological Distress (Based on the Hospital Anxiety and Depression Scale)|We used the Hospital Anxiety and Depression scale to measure overall psychological distress in family caregivers. The Hospital Anxiety and Depression Scale contains two subscales measuring depression and anxiety respectively. When examined continuously, this scale reflects degree of psychological distress with higher scores indicating more psychological distress (range 0-42). We compared overall psychological distress (HADS-total) among family caregivers between the two study arms|Week 12 and Week 24|Looking at the HADS-total score at week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the hospital anxiety and depression scale at these time points (study completers), which explains the discrepancy with the flow chart.|||units on a scale||95% Confidence Interval|Mean
2680354|NCT01401907|Secondary|Family Caregiver Quality of Life as Measured by the SF-36|The Medical Health Outcomes Survey- Short Form (SF-36) is a measure of QOL. The SF-36 measures eight domains of health-related quality of life: physical functioning, role limitation due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitation due to emotional health, and mental health. The response choices are scored and summed to yield two physical (PCS) and mental (MCS) component summary measures with ranges from 0-100. Higher scores indicate better quality of life. We compared family caregiver PCS and MCS scores between the two study arms at week-12 and week-24 adjusting for baseline scores.|Week-12 and Week-24|Adjusted Means controlling for baseline scores. The different rows reflect Week-12 and Week-24 outcomes on SF-36 PCS and MCS domains. The number of participants included in week-12 and week-24 analyses reflect the participants who completed the SF-36 at these time points, which explains the discrepancy with the flow chart.|||units on a scale||95% Confidence Interval|Mean
2680355|NCT01401907|Secondary|Number and Percentage of Participants Who Reported Goal of Their Cancer Treatment is to Cure Their Cancer|We used the response to an item on Perception of Treatment and Prognosis Questionnaire to compare rates of accurate prognostic understanding between study arms. Participants reported their primary goal of their current cancer treatment: 1) to cure my cancer; 2) to lesson my suffering as much as possible; 3) for me and/or my family to be able to keep hoping; 4) to make sure I have done everything; 5) to extend my life as long as possible; 6) to help cancer research. Participants' responses were dichotomized as 1) to cure my cancer vs. all other.|Week12 and Week 24|The different rows reflect analyses at week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the Perception of Treatment and Prognosis Questionnaire at these time points (study completers), which explains the discrepancy with the flow chart.|||Participants|||Count of Participants
2680543|NCT01400841|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline, 2 years postprocedure (extended follow-up)|Baseline measure not available for 1 of 11 participants.|||mm Hg||Standard Deviation|Mean
2680356|NCT01401907|Secondary|Rate of Clinically Significant Depression Symptoms Based on Hospital Anxiety and Depression Scale|The hospital anxiety and depression scale examines symptoms of depression and anxiety. We compared rates of clinically significant depression symptoms (using a cut off of 8 on the depression subscale score) between study arms at week-12 and week-24.|Week-12 and Week-24|The two rows examine outcomes at two different time points week-12 and week-24. Please note the number of participants included in week-12 and week-24 analyses reflect the participants who completed the hospital anxiety and depression scale at these time points (study completers), which explains the discrepancy with the flow chart.|||Participants|||Count of Participants
2680357|NCT01401907|Secondary|Functional Assessment of Cancer Therapy (Quality of Life Measure)|The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 24 weeks.|24 weeks|The analysis focuses on participants who completed week-24 questionnaires (N = 118 in the early palliative care arm, and N = 124 in the standard of care arm)|||units on a scale||95% Confidence Interval|Mean
2680358|NCT01401907|Primary|Functional Assessment of Cancer Therapy (Quality of Life Measure)|The Functional Assessment of Cancer Therapy - General is a quality of life measure with higher scores indicating better quality of life (range 0-108). We are examining the adjusted mean difference from baseline to 12 weeks in this study|12 weeks||||units on a scale||95% Confidence Interval|Mean
2680359|NCT01401842|Secondary|Dynamic Lumbar Extension Muscular Endurance at 11 Weeks|Dynamic lumbar extension muscular endurance (# repetitions at 50% peak torque) as assessed by a validated physical performance test on the lumbar dynamometer|11 weeks|Adjusted (by baseline score) isometric core muscular endurance in seconds (mean ± SE) at follow-up. Differences in sample sizes for this outcome (compared with primary outcome) are due to invalid test data for this outcome (n = 11 stabilization arm; n = 18 strengthening arm).|||repetitions||Standard Error|Mean
2680360|NCT01401842|Secondary|Isometric Core Muscular Endurance at 11 Weeks|Isometric core muscular endurance as assessed by a validated physical performance test (prone static plank test)|11 weeks|Adjusted (by baseline score) isometric core muscular endurance in seconds (mean ± SE) at follow-up. Differences in sample sizes for this outcome (compared with primary outcome) are due to invalid test data for primary outcome (n = 4 stabilization arm; n = 1 strengthening arm), and incomplete data for this outcome (n = 1 stabilization arm).|||seconds||Standard Error|Mean
2680361|NCT01401842|Primary|Isometric Lumbar Extension Muscular Strength at 11 Weeks|Isometric lumbar extension muscular strength (torque - Nm) as assessed by a validated physical performance test on the lumbar dynamometer|11 weeks|Adjusted (by baseline score) isometric lumbar extension muscular strength in Nm (mean ± SE) at follow-up|||Nm||Standard Error|Mean
2680362|NCT01401699|Primary|Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening|Collected entire distal esophagus OFDI Images analyzed and compared to the images obtained during standard of care surveillance endoscopy.|Images will be acquired during the OFDI imaging session which should take an average of 5 minutes|All subjects completed the study with no adverse events.|||Participants|||Count of Participants
2680363|NCT01401647|Secondary|Number of Participants Scoring at or Below a 3 on the MRS Scale|Neurologic status at discharge will be assessed using the modified Rankin Score (MRS). A higher value indicates a worse outcome. 0-No symptoms at all; 1-No significant disability despite symptoms; able to carry out all usual duties and activities, 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3-Moderate disability; requiring some help, but able to walk without assistance; 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6-Dead|Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.|MRS as a secondary outcome is not available on all patients that we have survival for.|||Participants|||Count of Participants
2680364|NCT01401647|Primary|Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge|Patients may die in the field (outside of the hospital at the time of the cardiac arrest), at the emergency room, in the hospital, or they are discharged alive from the hospital.|Patients will be followed from the time of the cardiac arrest until death, hospital discharge, or December 31, 2015, whichever occurs first.|The primary objective is to determine if survival to hospital discharge is improved with early therapeutic administration of IV amiodarone (PM101) compared to placebo.The secondary objectives of the trial are to determine if survival to hospital discharge is improved with early therapeutic administration of Lidocaine vs placebo; PM101 vs lidocaine.|||participants|||Number
2680365|NCT01401595|Secondary|Night Eating Symptoms|"The responses on the Night Eating Symptom Scale (NESS) will be examined over time.~Subjects will complete the NESS at their baseline visit, and at every treatment visit thereafter. The Night Eating Symptom Scale-II (NESS-II) (Lundgren, Allison, Vinai, & Gluck, 2012) is a 14-item questionnaire (possible range of 0-56, with higher scores indicating more severe symptoms) that assesses the presence of NES features over the course of the previous week. The NESS will indicate whether or not escitalopram is having an effect on our participants' night eating symptoms."|12 weeks||||units on a scale||Standard Error|Mean
2680366|NCT01401595|Secondary|Night Eating Symptoms|Number of nocturnal ingestions (waking and having something to eat) were reported at each visit.|12 weeks||||units on a scale||Standard Error|Mean
2680367|NCT01401595|Primary|Change in Symptoms of NES|Outcome of treatment will be measured by self report questionnaire, the Night Eating Symptom Scale ( higher score indicates worse symptoms). The percentage of calories consumed after dinner was estimated by recall at each treatment visit, as compared to their baseline % of intake after dinner, which was calculated through food diaries. The number of nocturnal ingestions (waking during the night and eating) per week was also recalled at each treatment visit.|12 weeks||||percentage of calories after dinner||Standard Error|Mean
2680368|NCT01401582|Secondary|Person With Dementia: Change in Medication|The DCM will conduct an IT-supported home medication review (Fiss et al., 2010) at the patients home with subsequent medication management by the local pharmacy regarding frequency of drug related problems, intake of PIM, clinically relevant drug-drug interaction, adherence, utilisation of adherence supporting activities (medication plan, drug dispenser, support by care service, reduction of the number of drugs taken|participants will be followed yearly until institutionalisation or death after an expected average of 5 years||2020-05-31|05/2020||||
2680370|NCT01401582|Secondary|Person With Dementia and Caregiver: Change in Health Status|"Several instruments will be used to assess the health of the person with dementia:~the GP records the Fragebogen zum SF12- health survey (SF-12, Bullinger et al. 1998) the standardized assessment of elderly in primary care (STEP; Sandholzer et al. 2004) the Brief Symptom Inventory (BSI; Derogatis et al. 1983) the Patient´s health questionnaire (PHQ-D; Löwe et al. 2002, Spitzer et al. 1999)"|participants will be followed yearly until institutionalisation or death after an expected average of 5 years||2020-05-31|05/2020||||
2680371|NCT01401582|Secondary|Person With Dementia: Change in Social Support|The F-SozU (Fydrich et al. 2007) will be used to assess social support in several domains|participants will be followed yearly until institutionalisation or death after an expected average of 5 years||2020-05-31|05/2020||||
2680372|NCT01401582|Secondary|Person With Dementia: Change in Activities of Daily Living|"The functional status was assessed using the Bayer Activities of Daily Living Scale (B-ADL). It coonsits of 25 Items indicating everyday problems/ challenges. Their occurence is rated on a scale of 1 never, to 10 always. All ratings are added and divided by the number of items. This yields a mean score of 1 to 10, where 1 indicates the lowest possible impairment and 10 indicates the highest possible impairment."|one year after baseline assessment||||units on a scale||Standard Deviation|Mean
2680373|NCT01401582|Primary|Reduction of Potential Inapropriate Medication (PIM)|"Having to deal with multimorbidity and polypharmacy in a sample of chronically ill elderly, we also analyze potentially inappropriate medication (PIM), defined as a drug for which the risk of an adverse event outweighs the clinical benefit, particularly when there is evidence in favor of a safer or more effective alternative therapy for the same condition. The PIM were identified using the Priscus list, which contains 83 drugs from 18 different drug classes."|one year after baseline assessment||||Participants|||Count of Participants
2680374|NCT01401582|Primary|Change in Medical Treatment With Antidementia Drugs|medication was systematically reviewed; A computer-based home medication review (HMR) encompasses all medications used by the study participants and includes questions about compliance, adverse effects and drug administration. The collection of primary data on medication in the context of the HMR includes both prescription drugs and over-the-counter drugs. The assignment was then integrated using a master file of the Pharmaceutical Index. The following antidementia drugs were considered: donepezil (N06AD02), rivastigmine (N06AD03), galantamine (N06AD04) and memantine (N06AX01).|one year after baseline assessment||||participants|||Number
2680375|NCT01401582|Primary|Change in Behavioral and Psychological Symptoms of Dementia|Neuropsychiatric Inventory (NPI; Cummings 1997); The NPI represents an interview by proxy on twelve dimensions of neuropsychiatric behaviors, i.e. delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. The presence (0= no, 1= yes) is asked. If present, the severity (rated 1 through 3; mild to severe) and frequency (1 to 4, rarely to very often) of each neuropsychiatric symptom are rated on. Thus the score for each dimension ranges from 0 = not present, 1= mildly and rarely to 12 = severe and often. A total NPI score is calculated as the sum of the frequency by severity scores ofeach domain range: 0 to 144, the higher the more neuropsychiatric symptomatic).|one year after baseline assessment||||units on a scale||Standard Deviation|Mean
2680376|NCT01401582|Primary|Change in Caregiver Burden|"Caregiver burden was assessed using the Berliner Inventar zur Angehörigenbelastung - Demenz (BIZA-D) (Zank et al., 2006). The BIZAD was developed to assess objective as well as subjective burden due to caring for a person wit dementia (PWD). It consists of 88 items covering 20 dimensions of caregiver burden. Objective burden is divided into six dimensions: 1) basic care tasks like support eating, hygiene etc (7 items), 2) extended care tasks like supporting grocery shopping, legal affairs etc. (3 items), 3) Motivation and Guidance (4 items), 4) emotional support (4 items), 5) supporting maintenance of social contacts (3 items) and 6) supervision (4 items). Each item has to be rated regarding the frequency of the support needed on a 5-Point scale (example: supervision; Does the patient need this kind of support: 1=always, 2= mostly, 3=partly, 4=hardly, 5= not at all). Then each item asks: Who is providing this support: all by someone else, mostly by someone else, evenly distributed"|one year after baseline assessment||||units on a scale||Standard Deviation|Mean
2680377|NCT01401582|Primary|Change in Quality of Life|The Quality of Life in Alzheimer's Disease (Qol-AD; Logsdon et al. 2002) was used. This measure designed specifically to obtain a rating of the patient's quality of life from both the patient and the caregiver. Each item is rated on a four point scale, with 1 being poor and 4 being excellent. Total scores, obtained by the sum of all 13 items, range from 13 to 52.|one year after baseline assessment||||units on a scale||Standard Deviation|Mean
2680378|NCT01401543|Secondary|Pharmacokinetics: Cmax of Tadalafil||Predose up to 96 hours postdose for each of the 4 treatment periods|Entire study population: All randomized participants.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2680379|NCT01401543|Secondary|Pharmacokinetics: AUC(0-∞) of Tadalafil||Predose up to 96 hours postdose for each of the 4 treatment periods|Entire study population: All randomized participants.|||nanograms*hours per milliliter (ng*h/mL)||Standard Deviation|Mean
2680380|NCT01401543|Primary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2452473||Predose up to 96 hours postdose for each of the 4 treatment periods|Entire study population: All randomized participants.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2680381|NCT01401543|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2452473||Predose up to 96 hours postdose for each of the 4 treatment periods|Entire study population: All randomized participants.|||nanograms*hours per milliliter (ng*h/mL)||Standard Deviation|Mean
2680382|NCT01401530|Secondary|Recommended Dose|This endpoint was combined with primary outcome measure, MTD|For each dose, first dose of study drug (Cycle 1 Day 1) to end of Cycle 1 (Day 21) (1 cycle = 3 weeks)|This endpoint was combined with primary outcome measure, MTD||||||
2680383|NCT01401530|Secondary|Total Clearance (CL)|Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. SerumPK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of CL, which was then summarized as the median and full range for all participants and expressed as milliliters/minutes/kilograms (mL/min/kg).|Cycle 1 (Day 1)|PK analysis set|||mL/min/kg||Full Range|Median
2680384|NCT01401530|Secondary|Volume of Distribution at Steady State (Vss)|Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Vss, which was then summarized as the median and full range for all participants and expressed as mL/kg.|Cycle 1 (Day 1)|PK analysis set|||mL/kg||Full Range|Median
2680385|NCT01401530|Secondary|Volume of Distribution at Terminal Phase (Vz)|Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Vz, which was then summarized as the median and full range for all participants and expressed as milliliters per kilogram (mL/kg).|Cycle 1 (Day 1)|PK analysis set|||mL/kg||Full Range|Median
2680386|NCT01401530|Secondary|Terminal Elimination Phase Half-life (t1/2)|Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of t1/2, which was then summarized as the median and full range for all participants and expressed in minutes.|Cycle 1 (Day 1)|PK analysis set|||Minutes||Full Range|Median
2680387|NCT01401530|Secondary|Terminal Phase Rate Constant (λz)|Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of λz, which was then summarized as the median and full range for all participants and expressed in 1/minutes.|Cycle 1 (Day 1)|PK analysis set|||1/minutes||Full Range|Median
2680388|NCT01401530|Secondary|Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf))|Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of AUC(0-inf), which was then summarized as the median and full range for all participants and expressed as ng*min/mL.|Cycle 1 (Day 1)|PK analysis set|||ng*min/mL||Full Range|Median
2680389|NCT01401530|Secondary|Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC(0-t))|Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of AUC(0-t), which was then summarized as the median and full range for all participants and expressed as nanograms*minutes per milliliter (ng*min/mL).|Cycle 1 (Day 1)|PK analysis set|||ng*min/mL||Full Range|Median
2680390|NCT01401530|Secondary|Time to Cmax (Tmax) of Denileukin Diftitox in Serum|Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Tmax, which was then summarized as the median and full range for all participants and expressed in minutes.|Cycle 1 (Day 1)|PK analysis set|||Minutes||Full Range|Median
2680391|NCT01401530|Secondary|Maximum Serum Concentration (Cmax) of Denileukin Diftitox|Cmax was defined as the maximum observed concentration of denileukin diftitox following administration of study treatment on Cycle 1 Day 1 and was obtained directly from the measured serum concentration-time curves. Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a lower limit of quantitation (LLOQ) of 30 nanograms per milliliter (ng/mL). Serum pharmacokinetic (PK) data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Cmax, which was then summarized as the median and full range for all participants and expressed as ng/mL.|Cycle 1 (Day 1)|PK analysis set included all participants in whom at least one PK parameter could be calculated.|||ng/mL||Full Range|Median
2680392|NCT01401530|Secondary|Number of Participants With Non-Serious Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Denileukin Diftitox|Safety assessments consisted of monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood coagulation, blood chemistry, and urinalysis values; periodic measurement of vital signs, body weight, 12-lead electrocardiograms (ECGs), Eastern Cooperative Oncology Group performance status, physical examination findings, and ophthalmological examination findings. TEAEs were defined as an AE that had an onset date, or worsening in severity from baseline (pre-treatment), on or after the first dose of study drug up to the last assessment. Treatment-related TEAEs included TEAEs that were considered by the investigator to be possibly or probably related to study drug. SAEs were defined as any untoward medical occurrence which results in death, was life-threatening, required hospitalization or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or caused a congenital anomaly/birth defect.|From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months|Safety Analysis Set (SAS) included all participants who received at least one dose of the study drug with at least one evaluable, post-baseline safety datum.|||Participants|||Number
2680544|NCT01400841|Secondary|Peak Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline, 6 months postprocedure|Baseline measure not available for 1 of 15 participants.|||mm Hg||Standard Deviation|Mean
2680393|NCT01401530|Primary|Maximum Tolerated Dose (MTD) and Recommended Dose (RD)|The MTD was defined as the maximum tolerated dose observed after the evaluation of dose limiting toxicity (DLT) in Cycle 1 with 6 participants. If it was judged that the dose was not tolerated and DLT was confirmed in only 3 participants in the lower dose cohort, 3 other participants were to be added and tolerability was evaluated with 6 participants in total. The RD was to be comprehensively determined based on the MTD and safety data. Participants not evaluable for DLT were defined as participants found to be ineligible or in whom DLT evaluation was impossible due to premature termination for reasons other than toxicities in the judgement of the Sponsor, among those who had received at least one dose of the investigational drug after enrollment.|For each dose, first dose of study drug (Cycle 1 Day 1) to end of Cycle 1 (Day 21) (1 cycle = 3 weeks)|DLT evaluation analysis set included all participants after excluding, from the Safety Analysis Set, participants who were non-evaluable for DLT.|||ug/kg/day|||Number
2680394|NCT01401517|Secondary|Assessment of Improvement of Quality of Life Using the WIQ (Walking Impairment Questionnaire) and SF-36 Questionnaire.|Demonstrate the pharmacodynamic effect of sodium nitrite on changes in measures of claudication symptoms using Quality of Life questionnaires (WIQ & RAND SF-36). The WIQ is a disease-specific instrument that measures community-based walking. The questionnaire consists of four subscales (pain severity, distance, speed, and stairs). The SF-36 is a set of 36 questions that the subject provides short answers on concerning general health issues that the subject chooses. Questionnaires were administered at baseline and again after 10 weeks of treatment. Scores from the individual sections were summed and divided by the maximal score for the section to obtain a percent score, ranging from 0 (inability to perform task) to 100 (no difficulty). The scores for each section at ten weeks was subtracted from the baseline scores for each section of the questionnaires. A negative represents declining function, a positive value represents improvement over the study period.|10 weeks|Change in scores on components of quality of life questionnaires at day 70 compared to baseline. The minimum (-100; represents worsening disease) and maximum differences (100, representing complete improvement) from baseline to 10 weeks for the total score of each subsection of the questionnaires are provided.|||units on a scale||Full Range|Median
2680395|NCT01401517|Secondary|Assessment of Changes in Walking Distance.|Demonstrate the pharmacodynamic effect of sodium nitrite on changes in functional measures of walking distance. The distance a subject can walk in 6 minutes will be measured prior to the first administration of the investigational product and 10 weeks after taking the investigational product but before the dose escalation. Distance walked in 6 minutes was measured at baseline and again after 10 weeks of treatment. The distance walked at ten weeks was subtracted from the baseline distance walked. A negative value represents a worsening of walking distance while a positive value represents an improvement in walking distance.|10 weeks|The change in distance walked in 6 minutes at Day 70 compared to baseline.|||Feet||Standard Deviation|Mean
2680396|NCT01401517|Secondary|Assessment of Changes in Brachial Artery Flow-Mediated Dilation (FMD)at 10 Weeks From Baseline|Demonstrate the pharmacodynamic effect of sodium nitrite on changes in FMD by imaging before investigational product administration and 10 weeks after administration of investigational product but before dose escalation. FMD was measured at baseline and again after 10 weeks of treatment. The value at ten weeks was subtracted from the baseline value. A negative value represents a worsening of FMD while a positive value represents an improvement in FMD.|10 weeks|Change in flow mediated dilation from baseline to final visit (10 weeks post-treatment)|||percentage from baseline in FMD||Standard Deviation|Mean
2680397|NCT01401517|Primary|Reporting of Adverse Events During 11 Week Treatment Period.|The primary objective of this clinical study is to evaluate the safety and tolerability of multiple doses of twice daily 40mg and 80mg sodium nitrite compared with placebo over a 10 week treatment period. Subjects will be asked to report any adverse events during the trial period, and blood pressure, methemoglobin levels and other blood chemistries will be assessed during the trial period for changes from baseline.|11 weeks||||participants|||Number
2680398|NCT01401478|Secondary|Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination|"The percentage of participants who developed hypercalcemia (too much calcium in the blood) and hyperphosphatemia (too much phosphate in the blood) leading to study termination was recorded.~Hypercalcemia was defined as calcium level greater than 11.2 mg/dL for more than 8 weeks, and hyperphosphatemia was defined as phosphate level greater than 6.5 mg/dL for more than 8 weeks."|6 months||||Percentage of participants||95% Confidence Interval|Number
2680399|NCT01401478|Secondary|Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study|The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at each visit post-baseline during the study was recorded.|6 months||||Percentage of participants||95% Confidence Interval|Number
2680400|NCT01401478|Secondary|Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study|The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at least once post-baseline during the study was recorded.|6 months||||Percentage of participants||95% Confidence Interval|Number
2680401|NCT01401478|Secondary|Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study|The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at each visit post-baseline during the study was recorded.|6 months||||Percentage of participants||95% Confidence Interval|Number
2680402|NCT01401478|Secondary|Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Least Once Post-baseline During the Study|The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at least once post-baseline during the study was recorded.|6 months||||Percentage of participants||95% Confidence Interval|Number
2680403|NCT01401478|Secondary|Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study|The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as the achievement of iPTH level 2 to 9 times the upper limit of normal) at each visit during the study was recorded.|6 months|The analysis for this outcome was based on the number of participants (55) who completed the study.|||Percentage of participants||95% Confidence Interval|Number
2680404|NCT01401478|Secondary|Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study|The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as achievement of iPTH level 2 to 9 times the upper limit of normal) at least once during the study was recorded.|6 months||||Percentage of participants||95% Confidence Interval|Number
2680405|NCT01401478|Primary|The Percentage of Participants Who Reached a Target Level of Intact Parathyroid Hormone (iPTH) (150-300 pg/mL) Post-baseline at Least Once During the Study|The percentage of participants who had a post-baseline intact parathyroid hormone (iPTH) level in the range of 150 to 300 pg/mL at least once during the study was recorded.|6 months||||Percentage of participants||95% Confidence Interval|Number
2680406|NCT01401465|Secondary|The Percentage of Subjects Experiencing AEs||Over both two-week treatment periods combined|ITT|||percentage of participants|||Number
2680407|NCT01401465|Secondary|The Number of Subjects Experiencing AEs||Over both two-week treatment periods combined|ITT|||participants|||Number
2680408|NCT01401465|Secondary|The Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Over both two-week treatment periods combined|ITT|||percentage of participants|||Number
2680409|NCT01401465|Secondary|The Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation||Over both two-week treatment periods combined|ITT|||participants|||Number
2680410|NCT01401465|Secondary|Work/Disability Days: Reduced Activity Days|Assessed at the end of each two-week treatment period|Period 1 (days 0-14), Period 2 (days 29-43)|IIT|||Incidence Rate (#events/person-days)|||Number
2680411|NCT01401465|Secondary|Work/Disability Days: Missed Work|Assessed at the end of each two-week treatment period|Period 1 (days 0-14), Period 2 (days 29-43)|ITT Population|||Incidence Rate (#events/person-days)|||Number
2680412|NCT01401465|Secondary|Work/Disability Days: Bed Days|Assessed at the end of each two-week treatment period|Period 1 (days 0-14), Period 2 (days 29-43)|ITT Population|||Incidence Rate (#events/person-days)|||Number
2680413|NCT01401465|Secondary|Treatment Outcome Composite Score Assessed at the End of the Study|Reflects preference on items concerned with perceived drug effectiveness (longer relief; symptom relief; prefer if both were the same price; for feeling better about your appearance; for few problems with irritation to nose; faster relief; how it makes your nose feel). The score is based on the proportion of items (x 100) preferred for ciclesonide and a score of 50 indicates an equal number of items preferred in the two groups. Larger values than 50 indicated greater than 50 percent of the subjects indicated preference for ciclesonide, while smaller values than 50 indicated greater than 50 percent preference for mometasone. Data is presented as the mean treatment outcome composite score. This analysis presents the comparison of ciclesonide versus mometasone in relation to preference for ciclesonide.|End of Study - Day 43|ITT Population|||Scores on a scale||Standard Deviation|Mean
2680414|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Work Well Being Questionnaire Scale|The mean of 1 question on how many days worked and 12 questions on level of satisfaction with work, ability to do work, problems completing work (physical and emotional); 1 questions on rating of leisure activities. Scores range from 1 (lower satisfaction) to 10 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2680415|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: General Health Perceptions Scale|The mean of 11 questions on sleep disturbance, vitality and general health status. Scores range from 100 (lower satisfaction) to 500 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2680416|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Mental and Emotional Health Scale|The mean of 24 questions encompassing anxiety, depression, and loss of behavioral and emotional control (Psychological Distress), life satisfaction, positive well being and emotional ties (Psychological Well Being).Scores range from 100 (lower satisfaction) to 500 (higher satisfaction)|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2680417|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Symptoms and Side-Effects Distress Scale|The mean of 48 questions including allergic-rhinitis and allergic-rhinitis treatment specific and general symptoms measured for prevalence, frequency and distress severity. Scores range from 100 (lower satisfaction) to 600 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2680418|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: General Symptom Interference Scale|"The mean of 7 questions concerning life interference due to nonallergic rhinitis specific symptoms (other symptoms or health problems such as fatigue, pain and depression with the same life activities: 1) work, 2) social events, 3) recreational activities, 4) exercise and physical activities, 5) work effectiveness, 6) enjoying life and 7) feeling your best. Scores range from 1 (lower satisfaction) to 10 (higher satisfaction)"|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2680430|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Interference|This subscale evaluates the patient's assessment of the degree to which allergy symptoms or side effects of the nasal spray interfered with daily routine, meals, recreation, family life, sleep schedules, energy levels, making plans, traveling, having fun and overall quality of life. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2680419|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Allergic-Rhinitis Specific Symptom Interference Scale|"The mean of 7 questions concerning interference with life activities due to the symptoms of allergic-rhinitis (nasal congestion, runny nose, itchy throat or sneezing) interfered with your ability to perform life activities. The life activities included: 1) work, 2) social events, 3) recreational activities, 4) exercise and physical activities, 5) work effectiveness, 6) enjoying life and 7) feeling your best. Scores range from 1 (lower satisfaction) to 6 (higher satisfaction)"|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2680420|NCT01401465|Secondary|The Change From Baseline in Health-Related Quality of Life: Perceived Health (Global Analogue Scale)|The mean of 5 questions: Feeling past month 1) overall or in general, 2) physically, 3) emotionally, 4) personal life and 5) about job or work. Scores range from 100 (lower satisfaction) to 500 (higher satisfaction)|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2680421|NCT01401465|Secondary|The Change From Baseline in Overall Quality of Life Composite Score|Mean of all items in the Mental and Emotional Health and General Health Perceptions scales. Scores range from 100 (lower satisfaction) to 500 (higher satisfaction)|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT|||scores on a scale||Standard Error|Least Squares Mean
2680422|NCT01401465|Secondary|The Change From Baseline in the Treatment Satisfaction Rating Scale: Perceived Relief|The patient's perceived level of relief along with the degree of satisfaction associated with that amount of relief was evaluated within this scale. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2680423|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Management|This subscale evaluates the patient's assessment of issues relating to dosing (number of times and the time required to dose), ability to remember to use the spray, the ease/difficulty of the spray and several questions further pertaining to the convenience of the treatment. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2680424|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Burden|This subscale evaluates the patient's assessment of the level of degree of burden that treatment for allergic rhinitis imposes on a number of areas, including adherence to the treatment regimen, exercise, performing daily activities, social activities, and enjoying life. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2680425|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Hassle|This subscale focuses specifically on the patient's assessment of the amount of bother and hassle of the treatment regimen, including coordinating activities, dosing, carrying supplies, rubbing nose or eyes, blowing nose repeatedly, or facial puffiness. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction). Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2680426|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Sensory Impact|This subscale evaluates the patient's assessment of the sensory attributes including medication running out of the nose, medication running down the throat, and impact on smell and taste. Issues regarding skipping the medication because of the way the nose feels and wanting to try other medications to find a better one are also included. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2680427|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Difficulties|This subscale evaluates the patient's degree of pain, discomfort and side effects perceived to be associated with treatment, and the extent to which pain and discomfort were bothersome. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2680428|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Role Limitation|This subscale evaluates the patient's assessment of the degree of interference with social interactions with family, friends, travel, having fun, problems in performing work or social roles and how flexible the treatment was with scheduling life activities. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2680429|NCT01401465|Secondary|Change From Baseline in the Treatment Satisfaction Rating Scale: Regimen Adaptation|This subscale evaluates the patient's assessment of the convenience of the treatment, whether the treatment was one the subject would recommend to other persons with the same condition, and the level of satisfaction with the current treatment. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||units on a scale||Standard Error|Least Squares Mean
2680431|NCT01401465|Secondary|Change From Baseline in the Regimen Acceptance Composite Score|A combination of the Perceived Relief Scale and the Regimen Adaptation Scale. The composite score and all subscales range from 0 (lower satisfaction) to 100 (higher satisfaction). This is an unweighted average of the combined scales.|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||scores on a scale||Standard Error|Least Squares Mean
2680432|NCT01401465|Secondary|Change From Baseline in the Treatment Functional Impact Composite Score|A combination of the Interference Scale, the Role Limitation Scale, and the Burden Scale. The composite score and the subscales all range from 0 (lower satisfaction) to 100 (higher satisfaction). This is an unweighted average of the combined scales.|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||scores on scale||Standard Error|Least Squares Mean
2680433|NCT01401465|Secondary|Change From Baseline in Subject-reported AM and PM rTNSS Averaged Over Each 2-week Treatment Period.|The reflective Total Nasal Symptom Score (rTNSS) is the sum of 4 Nasal Symptoms: Runny Nose, Sneezing, Itchy Nose, and Nasal Congestion. These symptoms were assessed each morning and evening, and their totals averaged to obtain a daily average rTNSS. These daily averages were averaged over the 6 days prior to treatment to obtain the baseline value, and over the 14 days of each two-week period to obtain the on-treatment averages. The baseline values were then subtracted from the on-treatment averages to obtain the change from baseline scores. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent, 1 = mild ,2 = moderate ,3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.|Averages over each two week treatment period|Per Protocol (PP) Population|||units on a scale||Standard Error|Least Squares Mean
2680434|NCT01401465|Secondary|Treatment Process Composite Preference Score|"The Treatment Process Composite Preference Score is a standardized sum of 9 individual preference items (Ease of use, Convenience, Flexibility Daily Activity, Taste, Use in public, Smell. Less Run out of nose, Less Run down of throat, Number Sprays Dose). For each of these 9 individual items, patients were forced to choose their preference between ciclesonide nasal aerosol 74 mcg and mometasone AQ 200 mcg. Larger values greater than 50 indicated greater preference for ciclesonide, while smaller values less than 50 indicated greater preference for mometasone."|End of Study - Day 43|ITT|||scores on a scale||Standard Deviation|Mean
2680435|NCT01401465|Primary|Change From Baseline in Regimen Attributes Composite Score|The Regimen Attributes Composite Score is a composite of the Sensory Impact and Regimen Management Scales of the Allergic Rhinitis Treatment Satisfaction and Preference Scales. The Regimen Management Scale assess patient satisfaction with issues relating to dosing, ability to remember to use the spray, the ease/difficulty of the spray, and convenience of the treatment. The Sensory Impact Scale assess patient satisfaction with issues relating to sensory attributes, including medication running out of the nose, medication running down the throat, impact on smell/taste, etc. Scores range from 0 (lower satisfaction) to 100 (higher satisfaction).|Baseline for this measurement was Day 1 for Treatment Period 1 and Day 29 for Treatment Period 2. The assessment for Treatment Period 1 was on Day 14 and for Treatment Period 2 on Day 42|ITT Population|||scores on a scale||Standard Error|Least Squares Mean
2680436|NCT01401465|Primary|Total Preference Composite Score Assessed at the End of the Study. The Total Preference Score is the Standardized Sum of 17 Individual Preference Items|"For the 17 individual items, patients were forced to choose their preference between ciclesonide and mometasone (item choices: 1 = prefer ciclesonide; 0 = prefer mometasone). The items for the Total Preference Score assessed 16 treatment attributes and one overall treatment preference: Ease of use, Convenience, Flexibility in daily activities, Taste, Use in public, Smell, Less run out of nose, Longer relief, Less run down of throat, Symptom relief, If both were the same price, Better appearance, Less nasal irritation, Faster relief, Number of sprays per dose, Makes nose feel, and Overall - the one preferred. The score is based on the proportion of items (x 100) preferred for ciclesonide and a score of 50 indicates no preference and scores over 50 indicate preference for ciclesonide. This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide."|End of Study - Day 43|Intent to Treat (ITT)- All randomized subjects who received at least one dose of study medication|||scores on a scale||Standard Deviation|Mean
2680437|NCT01401452|Secondary|Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst-100 best). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months. The percentage of participants achieving MCID in the SF-36 MCS was defined as an increase in MCS of at least 5 points from the baseline score."|Baseline, Months 1, 3, 6, and 9|Participants with available data|||percentage of participants|||Number
2680445|NCT01401452|Primary|Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Months 1, 3, 6, and 9|The percentage of participants with a ≥ 75% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline, Months 1, 3, 6, and 9|Participants with available data|||percentage of participants|||Number
2684230|NCT01369732|Secondary|the Duration of Mechanical Ventilation|Participants will be followed for the duration of mechanical ventilation, an expected average of 2 weeks after surgery.|upto 2 weeks after surgery|||||||
2680438|NCT01401452|Secondary|Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst-100 best). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months. The percentage of participants achieving MCID in the SF-36 PCS was defined as an increase in PCS of at least 3 points from the baseline score."|Baseline, Months 1, 3, 6, and 9|Participants with available data|||percentage of participants|||Number
2680439|NCT01401452|Secondary|Mean Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst-100 best). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months."|Baseline, Months 1, 3, 6, and 9|Participants with available data. Missing values were imputed if single answers were missing for one dimension.|||units on a scale||Standard Deviation|Mean
2680440|NCT01401452|Secondary|Mean Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst-100 best). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months."|Baseline, Months 1, 3, 6, and 9|Participants with available data. Missing values were imputed if single answers were missing for one dimension.|||units on a scale||Standard Deviation|Mean
2680441|NCT01401452|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index 100 (PASI 100) Response at Months 1, 3, 6, and 9|The percentage of participants with a ≥ 100% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline, Months 1, 3, 6, and 9|Participants with available data|||percentage of participants|||Number
2680442|NCT01401452|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI 90) Response at Months 1, 3, 6, and 9|The percentage of participants with a ≥ 90% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline, Months 1, 3, 6, and 9|Participants with available data|||percentage of participants|||Number
2680443|NCT01401452|Secondary|Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI 50) Response at Months 1, 3, 6, and 9|The percentage of participants with a ≥ 50% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.|Baseline, Months 1, 3, 6, and 9|Participants with available data|||percentage of participants|||Number
2680444|NCT01401452|Secondary|Mean Dermatology Life Quality Index (DLQI) Scores|The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment- related feelings. Participants respond to 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.|Baseline, Months 1, 3, 6, and 9|Participants with available data|||units on a scale||Standard Deviation|Mean
2680460|NCT01401166|Secondary|3-Year EFS Rate|EFS events included local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The proportion of participants without an EFS event (i.e., the EFS rate) and corresponding 95% CI at 3 years after randomization was reported.|Year 3|ITT Population|||proportion of participants||95% Confidence Interval|Number
2680446|NCT01401361|Secondary|Secondary Efficacy|"Secondary efficacy / Chronic success is defined as freedom from recurrence of typical atrial flutter 3 months post ablation. Flutter recurrence will be documented on an ECG (or similar such as Holter, telemetry, rhythm strips, etc.). Repeat ablations, new antiarrhythmia medication (Class Ia, Ic, or III) or increase in the dosage of existing anti-arrhythmic medication (Class 1a,~1c, III) during the 3 months post ablation are considered chronic failures."|3 months|134 subjects were treated with the investigational catheter and system with 10 subjects experiencing recurring AFL. Thus 124 subjects comprised the secondary efficacy cohort (freedom from AFL at 90 days).|||participants|||Number
2680447|NCT01401361|Primary|Primary Efficacy|Primary efficacy or Acute success is defined as achievement of bidirectional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system.|30 minutes|134 subjects were treated with the investigational catheter and system with 1 subject failing to pass the bidirectional block inducibility test 30 minutes post ablation. Thus 133 subjects comprised the primary efficacy cohort.|||participants|||Number
2680448|NCT01401361|Primary|Primary Safety:Incidence of Composite, Serious Adverse Events Within 7 Days Post Procedure|Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.|7 days|150 subjects who met Inc/Excl criteria were enrolled. 16 subjects were withdrawn prior to the use of the investigational device, thus,134 were treated. 3 subjects had composite adverse events that were serious and occurred within 7 days of the ablation procedure. These events are part of the primary safety endpoint analysis per protocol.|||participants|||Number
2680449|NCT01401322|Primary|Time-to-Progression (TTP)||12 weeks||||Days||Full Range|Median
2680450|NCT01401283|Secondary|Hospital Stay|length of stay in the postoperative care unit, length of hospital stay|Participants will be followed for the duration of hospital stay, an expected average of 10 days||||days||Inter-Quartile Range|Median
2680451|NCT01401283|Primary|Postoperative Complications|Categories of postoperative complications: Infection (respiratory, abdominal, UTI, wound), Respiratory (prolonged need for ventilation), Cardiovascular (edema, arrythmia, hypotension, AMI, stroke), Abdominal (constipation), Renal (urine output <500ml/d, ARF)|Participants will be followed from end of surgery for the duration of stay in the recovery room, for the duration of the complete hospital stay, an expected average of ten 10 days||||numbers of complications|||Number
2680452|NCT01401257|Secondary|To Assess the Plasma Concentrations of PXT3003|PXT3003 plasmatic concentrations after one administration (randomization) and after 1-,6-and 12-months of treatment.|Randomization, 1-, 6- and 12-month treatment|||||||
2680453|NCT01401257|Secondary|To Assess the Pharmacodynamic Effect of PXT3003 on a Series of Biochemical Biomarkers|"Dosages of biochemical biomarkers in plasma.~Change from baseline after 3-month of treatment."|Randomization and 3-month treatment|||||||
2680454|NCT01401257|Secondary|To Assess the Pharmacodynamic Effect of PXT3003 on Selected Neurophysiological Parameters|"Electrophysiological examination will be performed to assess sensory and motor responses of the median and ulnar nerves (non-dominant side) including: NCV, compound muscle action potential (CMAP) and SNAP.~Change from baseline after 3-,6-, 9- and 12-months of treatment."|Screening, randomization, 3-, 6-, 9- and 12-month treatment|||||||
2680455|NCT01401257|Secondary|To Assess the Pharmacodynamic Effect of PXT3003 on PMP22 mRNA Levels and Intra-epidermal Axon Density in Cutaneous Biopsy|"A cutaneous biopsy (consisting in 2 small punch biopsies) will be performed to assess PMP22 mRNA expression and intra-epidermal axon density.~Change from baseline after 12-month of treatment."|Randomization and 12-month treatment|||||||
2680456|NCT01401257|Secondary|To Obtain Preliminary Data on the Efficacy of PXT3003 on Clinical Scores and Functional Tests|"Efficacy scores and functional tests will be assessed CMTNS/CMTES:ONLS, VAS, fatigue, pain, six minute walk test (6MWT), nine-hole peg test, quantified muscular testing (QMT; hand grip and foot dorsiflexion), CGI.~For each test or score, change from baseline after 3-,6-, 9- and 12-months of treatment."|Screening, randomization, 3-, 6-, 9- and 12-months treatment|||||||
2680457|NCT01401257|Primary|Safety and Tolerability of PXT3003|"The Primary Objective is to assess the clinical and laboratory safety and tolerability of three doses of PXT3003 administered orally for 12 months to CMT1A patients versus placebo.~Number of participants with adverse events in each arm."|Screening, randomization, 1-, 3-, 6-, 9-, 12-month treatment and 1-month follow-up||||Participants|||Count of Participants
2680458|NCT01401166|Secondary|Percentage of Participants With Anti-Trastuzumab or Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies|Participants in Cohort 1 provided blood samples for immunogenicity testing to assess for anti-drug antibodies (ADAs) to trastuzumab or rHuPH20, a component of the SC Herceptin formulation. The percentage of participants who were trastuzumab ADA-positive and the percentage of participants who were rHuPH20 ADA-positive were each reported.|Baseline, pre-dose (0 hours) during Cycle 5 (cycle length of 3 weeks)|Safety Population. Results were planned to be analyzed for only Cohort 1 because the objective of the study was to evaluate immunogenicity within participants who received the SID formulation of Herceptin. The number of participants who provided ADA samples at each timepoint (n) is shown in the table.|||percentage of participants|||Number
2680459|NCT01401166|Secondary|"Percentage of Participants With Responses of Agree or Strongly Agree on the SC SID Satisfaction Questionnaire"|"Participants who performed self-administration of SC Herceptin via SID were given an evaluation questionnaire during the continuation period (Weeks 25 to 52) after their first self-administration. Participants responded to 5 statements about their comfort with self-injection, the convenience of the SID, their self-confidence using the SID, their satisfaction with the SID, and whether they would consider using the SID again in the future. Each statement used a 5-item rating scale with responses from Strongly Disagree to Strongly Agree. The percentage of participants with a positive response (either Agree or Strongly Agree) to each questionnaire statement was reported."|Immediately following first self-administration of SC Herceptin via SID (once during Weeks 25 to 52)|"Safety Population. The Number of Participants Analyzed reflects those who self-administered SC Herceptin using the SID and completed the SC SID questionnaire. Results were planned to be analyzed for only Cohort 1 because the objective of the study was to evaluate satisfaction among those who self-administered the SID formulation of Herceptin."|||percentage of participants|||Number
2680540|NCT01400841|Secondary|LV Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 8 of 15 participants|||g||Standard Deviation|Mean
2680461|NCT01401166|Secondary|Duration of EFS According to Kaplan-Meier Estimate|EFS was defined as the time from randomization to a local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The median duration of EFS and corresponding 95 percent (%) CI according to Kaplan-Meier estimates were planned to be reported and expressed in months.|From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)|ITT Population|||months||95% Confidence Interval|Median
2680462|NCT01401166|Secondary|Percentage of Participants With an Event-Free Survival (EFS) Event|EFS events included local, regional, or distant recurrence of the original breast cancer, occurrence of contralateral breast cancer, or death due to any cause. The percentage of participants who had an EFS event at any time on study was reported.|From Baseline until time of event; assessed every 6 months (median follow-up of 3 years)|ITT Population|||percentage of participants|||Number
2680463|NCT01401166|Secondary|Percentage of HCPs by Time Required to Perform Each Method of Drug Administration|"The time required to perform each method of drug administration was assessed via questionnaire with each HCP by asking to rate the amount of time it took to administer each method of drug administration (IV or SC Herceptin) at the end of the crossover period (Week 24). Time was rated in the following time block categories: less than (<) 5 minutes, 6 to 10 minutes, 11 to 15 minutes, 16 to 20 minutes, and greater than (>) 20 minutes. Responses of Not Sure and Unknown were also allowed. The percentage of HCPs who rated the amount of time in each of the categories was reported."|Week 24|HCP Population. Results were planned to be analyzed for all HCPs combined because the objective of the study was to compare HCP perceived time savings with use of SC over IV Herceptin.|||percentage of HCPs|HCPs||Number
2680464|NCT01401166|Secondary|Percentage of HCPs by Most Satisfied Method of Drug Administration|"The method of drug administration with which HCPs were most satisfied (IV or SC Herceptin) was assessed via questionnaire with each HCP using the question, All things considered, with which method of administration were you most satisfied? at the end of the crossover period (Week 24). The percentage of HCPs who were most satisfied with each method of drug administration was reported."|Week 24|HCP Population: All HCPs who participated in the study and completed the HCP questionnaire. Results were planned to be analyzed for all HCPs combined because the objective of the study was to compare preference between SC and IV Herceptin.|||percentage of HCPs|HCPs||Number
2680465|NCT01401166|Primary|Percentage of Participants by Preferred Method of Drug Administration|"The preferred method of drug administration (IV or SC Herceptin) was assessed in trial-specific telephone interviews with each study participant. Participants were asked, All things considered, which method of administration did you prefer? at the end of the crossover period (Week 24). The percentage of participants who preferred each method of drug administration was reported."|Week 24|Intent-to-Treat (ITT) Population: All participants who received both IV and SC Herceptin and who completed the trial-specific telephone interview conducted after the end of the crossover period.|||percentage of participants|||Number
2680466|NCT01401153|Primary|Mean Time Incorrect Reactions|Mean time to react incorrectly|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Seconds||Inter-Quartile Range|Median
2680467|NCT01401153|Primary|Mean Time Correct Reactions|Mean time to react correctly|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Seconds||Inter-Quartile Range|Median
2680468|NCT01401153|Primary|Incorrect Reactions|Number of incorrect reactions|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Incorrect reactions||Inter-Quartile Range|Median
2680469|NCT01401153|Primary|Number Correct Reactions|Number of correct reactions|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Correct reactions||Inter-Quartile Range|Median
2680470|NCT01401153|Primary|Percentage Incorrect Reactions|Percentage of incorrect reactions|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Incorrect reactions %||Inter-Quartile Range|Median
2680471|NCT01401153|Primary|Reactions|Number of total reactions (Subjects have to decide whether a displayed figure is identical with one of four figures shown or not)|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Total reactions||Inter-Quartile Range|Median
2680472|NCT01401153|Primary|Sequencing Errors|Sequences including all the blocks of a prescribed sequence, but in the wrong order|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Sequences with wrong order||Inter-Quartile Range|Median
2680473|NCT01401153|Primary|Correct Immediate Block Span|Number of sequences correctly reproduced|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Sequences correctly reproduced||Inter-Quartile Range|Median
2680474|NCT01401153|Primary|Incorrect Immediate Block Span|Number of sequences incorrectly reproduced|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Sequences incorrectly reproduced||Inter-Quartile Range|Median
2680475|NCT01401153|Primary|Immediate Block Span|Longest sequence correctly reproduced in at least two of three items (the test is a task of reproducing prescribed sequences from two to eight blocks)|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Longest sequence correctly reproduced||Inter-Quartile Range|Median
2680476|NCT01401153|Primary|Tonic Alertness (Omission Errors)|Stimuli to which no reaction follows within 1.5s|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Omission errors||Inter-Quartile Range|Median
2680477|NCT01401153|Primary|Tonic Alertness (Commission Errors)|Reactions when no stimulus had been presented|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Commission errors||Inter-Quartile Range|Median
2680478|NCT01401153|Primary|Tonic Alertness (Deviation of Reaction Time)|Deviation of reaction time --> logarithmic standard deviation of the reaction times|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Unitless||Inter-Quartile Range|Median
2680479|NCT01401153|Primary|Tonic Alertness (Mean Reaction Time)|Mean reaction time to response to a simple visual stimulus without a preceding warning signal|Participants were tested twice with one week wash out (1h after having/skipping lunch)|Complete case analysis|||Milliseconds||Inter-Quartile Range|Median
2680480|NCT01401101|Primary|PTSD Symptoms|same as baseline and 6 months|12 months|Clinician-Administered PTSD Scale (CAPS) severity score: sum of ratings (from 0-4) for frequency and intensity across each of the 17 symptom items for a possible range of 0-136, where a higher score indicated higher severity.|||CAPS scores||95% Confidence Interval|Mean
2680481|NCT01401101|Primary|PTSD Symptoms|same as baseline|6 months|Clinician-Administered PTSD Scale (CAPS) severity score: sum of ratings (from 0-4) for frequency and intensity across each of the 17 symptom items for a possible range of 0-136, where a higher score indicated higher severity.|||CAPS scores||95% Confidence Interval|Mean
2680482|NCT01401101|Primary|PTSD Symptoms|Clinician-Administered PTSD Scale (CAPS) severity score: sum of ratings (from 0-4) for frequency and intensity across each of the 17 symptom items for a possible range of 0-136, where a higher score indicated higher severity.|0 months (baseline)|all patients who completed the assessment|||CAPS scores||95% Confidence Interval|Mean
2680483|NCT01401062|Primary|Abscopal Response Rate|Defined as the percentage of patients who have responses (complete or partial) outside the irradiated lesions. The abscopal response is assessed at 15 weeks, and confirmed minimum 4 weeks later. The abscopal response is evaluated based on immune-related response criteria (irRC) (Wolchok et al, 2009).|up to 20 weeks||||Participants|||Count of Participants
2680484|NCT01401049|Secondary|To Compare Patient Satisfaction With Sedation Including the Recall of Pain.|We hypothesize that we can reject the null hypothesis that results from all 3 arms are from the same sample, and then show (in pair wise tests) that fospropofol is superior to propofol, and not-inferior to propofol plus lidocaine.|2 hours after the end of the procedure.|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2680485|NCT01401049|Primary|Compare Incidence and Intensity of Pain on Injection That is Caused by Propofol (Lipid Emulsion) Versus the Test Drug Fospropofol.|We hypothesize that we can reject the null hypothesis that results from all 3 arms are from the same sample, and then show (in pair wise tests) that fospropofol is superior to propofol, and not-inferior to propofol plus lidocaine.|2 hours|Due to flooding from Hurricane Sandy at our site, all files and pertinent patient data were lost.||||||
2680486|NCT01401023|Primary|Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile|Stool levels of tigecycline|day 3 of treatment||||micrograms/gram||Standard Deviation|Mean
2680487|NCT01401023|Primary|Mean (SD) Stool Tigecycline Concentration Level|Fecal samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Fecal concentrations were determined with the use of a validated high-performance liquid chromatography assay|day 3 of tigecycline therapy||||micrograms/gram||Standard Deviation|Mean
2680488|NCT01401023|Primary|Mean (SD) Serum Tigecycline Concentration Level|Blood samples were obtained from each patient at the end of a dosing interval (trough concentration) on day 3 of tigecycline therapy. Serum concentrations were determined with the use of a validated high-performance liquid chromatography assay.|day 3 of tigecycline therapy||||milligram/liter||Standard Deviation|Mean
2680489|NCT01401023|Primary|Mean (SD) Minimun Inhibitory Concentration of Tigecycline of Clostridium Difficile Isolates||day 1 stool sample||||milligram/liter||Standard Deviation|Mean
2680490|NCT01401023|Primary|Pharmacokinetics of Tigecycline Along With Standard Treatments for Clostridium Difficile|Serum levels of tigecycline|day 3 of treatment||||milligrams/liter||Standard Deviation|Mean
2680491|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic area under serum curve of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.|||milligrams * hour/liters||Standard Deviation|Mean
2680492|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic clearance of drug of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.|||Liters/hour||Standard Deviation|Mean
2680493|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic (PK) Half Life Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic half life of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.|||hours||Standard Deviation|Mean
2680494|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic (PK) Elimination Rate Constant Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic elimination rate constant of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.|||hour^-1||Standard Deviation|Mean
2680495|NCT01401010|Secondary|Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported as Probability of Target Attainment (40% Time (fT) > Minimum Inhibitory Concentrations (MIC))|"Following determination of pharmacokinetic (PK) parameters from patients with febrile neutropenia, Monte Carlo simulations were then conducted to determine time of serum concentrations above the MIC (40% of the time) against Gram-negative isolates.~These Gram-negative isolates had a range of minimum inhibitory concentrations (MIC) to Doripenem."|1, 4, 6, 8 hours after an infusion of doripenem to determine the PK parameters|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.|||probability of target attainment|||Number
2680496|NCT01401010|Primary|Mean (SD) Doripenem Pharmacokinetic Volume of Distribution Parameter in Febrile Neutropenic Patients|To determine the serum pharmacokinetic volume of distribution of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay.|1, 4, 6, 8 hours after at least two doses of drug|Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing.|||Liters||Standard Deviation|Mean
2680497|NCT01400971|Secondary|Number of Participants Who Achieved Their Personalized HbA1c Target by the End of the Study|As diabetes management practices vary across the countries represented in MOSAIC, a more apt measure of reaching goal is the personalized target that was set for each patient at the beginning of the study.|Baseline through 24 months|All participants enrolled in MOSAIc who had complete treatment data during the study.|||Participants|||Count of Participants
2680498|NCT01400971|Secondary|Number of Participants Adherent to Prescribed Insulin Therapy During the Study (Study Adherent)|"MOSAIC participants answered the question: How often did you miss your insulin shots during the last 7 days?. At each visit, participants were defined as visit adherent if the participant answered I did not miss any shots or I missed some of my shots. They were defined as not visit adherent if he/she answered any of the following: I missed about half of my shots, I missed most of my shots, or I missed all of my shots. A participant is defined to be study adherent if at least: 4 out of 5 visit adherent."|Baseline through 24 months|All participants enrolled in MOSAIc who had complete treatment data during the study.|||Participants|||Count of Participants
2680499|NCT01400971|Secondary|Number of Hypoglycemic and Severe Hypoglycemic Episodes|Hypoglycemia and severe hypoglycemia episodes are self-reported by all participants with complete treatment data from one month prior to the baseline visit until the last visit (24 months). Patients were asked at each visit to self-report any hypoglycemia since their last visit. At the baseline visit participants were asked their hypoglycemia information for the month prior to the baseline visit.|Baseline through 24 months|All participants enrolled in MOSAIc who had complete treatment data during the study.|||episodes|||Number
2680500|NCT01400971|Primary|Number of Participants With Insulin-Related Treatment Change From Initial Insulin Therapy|Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy. Discrimination domain of the Interpersonal Processes of Care Survey [IPC] ranges from 1-5 with higher scores indicating more discrimination and Diabetes Distress Scale ranges from 1-6 with higher scores indicating more distress.|Baseline through 24 months|All participants enrolled in MOSAIc who had complete treatment data during the study.|||Participants|||Count of Participants
2680501|NCT01400958|Secondary|Occurrence of Improved Cognitive Performance|Determine if Nuvigil® improves cognitive function of patients receiving external beam radiation therapy for the treatment of malignant gliomas. Participants who maintained average (T=50) to slightly below average (T=40 or greater) cognitive function.|5 months|Available, evaluable participants with average T Score range cognitive function at baseline|||participants|||Number
2680502|NCT01400958|Primary|Occurrence of Improved Fatigue Experience After Treatment|Determine if Nuvigil® improves fatigue experienced by patients receiving external beam radiation therapy for the treatment of malignant gliomas. Participants who maintained minimal, or experienced improved fatigue experience on a scale of 0 (No fatigue) - 10 (As bad as you can imagine).|5 months|Available, evaluable participants with minimal fatigue at baseline|||participants|||Number
2680503|NCT01400932|Secondary|Mean Change From Baseline in Itching and Burning/Stinging Scores at Weeks 1, 2, 4, 8, 12/Withdrawal|Itching and burning/stinging were evaluated by the participant as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (mild)=noticeable discomfort that caused continuous awareness; 3 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 4 (severe)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the post-Baseline/Withdrawal value minus the Baseline value.|Baseline; Weeks 1, 2, 4, 8, 12 or withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Scores on a scale||Standard Deviation|Mean
2680504|NCT01400932|Secondary|Mean Change From Baseline in Erythema, Dryness, and Peeling Scores at Weeks 1, 2, 4, 8, 12/Withdrawal|Erythema (redness), dryness, and peeling were evaluated independently by the investigator as: 0 (absent)=no erythema, dryness, or peeling; 1 (slight)=faint red/pink coloration, barely perceptible dryness with no flakes or fissure, mild localized peeling; 2 (mild)=light red/pink coloration, perceptible dryness with no flakes/fissure, mild and diffuse peeling; 3 (moderate)=medium red coloration, easily noted dryness and flakes but no fissure, moderate and diffuse peeling; 4 (severe)=beet red coloration, dryness with flakes and fissure, prominent dense peeling. Change from Baseline was calculated as the post-Baseline/Withdrawal value minus the Baseline value.|Baseline; Weeks 1, 2, 4, 8, 12 or Withdrawal|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points/for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Scores on a scale||Standard Deviation|Mean
2680505|NCT01400932|Secondary|Number of Participants Who Had a Reduction in Total Lesions of at Least 50% From Baseline to Weeks 1, 2, 4, 8, and 12|The proportion of participants who have a reduction in total lesions (inflammatory and non-inflammatory) of at least 50% from Baseline at Weeks 1, 2, 4, 8, and 12 was measured.|Baseline; Weeks 1, 2, 4, 8, and 12|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
2680506|NCT01400932|Secondary|Number of Participants Who Had an ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8, and 12|Investigators evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no inflammatory lesions (ILs) or non-inflammatory lesions (NILs); 1=almost clear: rare NILs with no more than rare papules; 2=mild acne: greater than Grade 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate acne: greater than Grade 2, up to many NILs and had some ILs, but no more than one small NL; 4=severe acne: greater than Grade 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe acne: many NILs and ILs and more than a few NLs, had cystic lesions.|Weeks 1, 2, 4, 8, and 12|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Participants|||Number
2680507|NCT01400932|Secondary|Number of Participants Who Had a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12|Investigators evaluated the acne severity of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no inflammatory lesions (ILs) or non-inflammatory lesions (NILs); 1=almost clear: rare NILs with no more than rare papules; 2=mild acne: greater than Grade 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate acne: greater than Grade 2, up to many NILs and had some ILs, but no more than one small NL; 4=severe acne: greater than Grade 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe acne: many NILs and ILs and more than a few NLs, had cystic lesions.|Baseline and Week 12|ITT Population. Only those participants with data available at the specified time point were analyzed.|||Participants|||Number
2680508|NCT01400932|Secondary|Percent Change From Baseline in Total, Inflammatory, and Non-inflammatory Lesion Counts to Weeks 1, 2, 4, 8, and 12|The percent change from Baseline to Weeks 1, 2, 4, 8, and 12 in lesion counts (total [inflammatory and non-inflammatory], inflammatory [IL], and non-inflammatory [NIL]) was analyzed using an ANOVA model with terms for treatment and center. Percent change from Baseline was calculated as: (post-Baseline value minus Baseline value) * 100.|Baseline; Weeks 1, 2, 4 and 8 and 12|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Percent change in lesion counts||Standard Error|Least Squares Mean
2680509|NCT01400932|Secondary|Absolute Change From Baseline in Inflammatory Lesion (IL) Count and Non-inflammatory Lesion (NIL) Count to Weeks 1, 2, 4, 8, and 12|The investigator/subinvestigator counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedo) on the face at each study visit. An open comedo is an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Data were analyzed using an ANCOVA model with terms for Baseline value, treatment, and center.|Baseline; Weeks 1, 2, 4, 8, and 12|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Lesion counts||Standard Error|Least Squares Mean
2680510|NCT01400932|Secondary|Absolute Change in Total Lesion Counts From Baseline to Weeks 1, 2, 4, and 8|The investigator/subinvestigator counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedo) on the face at each study visit. An open comedo is an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter.Data were analyzed using an ANCOVA model with terms for Baseline value, treatment, and center.|Baseline; Weeks 1, 2, 4, and 8|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.|||Lesion counts||Standard Error|Least Squares Mean
2680511|NCT01400932|Primary|Absolute Change in Total Lesion Counts From Baseline to Week 12|The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedos; diagnosis based on palpation) on the face at each study visit. An open comedo is an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedo is a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule is a small, raised, red, dome-shaped palpable lesion. A pustule is a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule may be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter.|Baseline and Week 12|Intent-to-Treat (ITT) Population: all randomized participants who received at least one application of investigational product. Only those participants with data available at the specified time point were analyzed. Analysis was based on an analysis of covariance (ANCOVA) model with terms for Baseline value, treatment, and center.|||Lesion counts||Standard Error|Least Squares Mean
2680512|NCT01400919|Primary|Major Adverse Event Rate||9 months||||percentage of participants|||Number
2680513|NCT01400906|Secondary|Neutrophil and Eosinophil Cell Counts in Induced Sputum on Day 7 of Each Treatment Period|Sputum induction was performed using hypertonic saline solution to collect an adequate sample of secretions from lungs. The collected sputum was analyzed for neutrophil and eosinophil counts. Sputum induction was performed after methacholine challenge and post-dose administration on Day 7. Zero values are imputed to 0.001 for this analysis. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 7 of each treatment period (up to 11 weeks)|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PD Population.|||10^4 cells per gram of sputum||95% Confidence Interval|Geometric Mean
2680541|NCT01400841|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline, 2 years postprocedure (extended follow-up)|Baseline measure not available for 1 of 11 participants.|||mm Hg||Standard Deviation|Mean
2680542|NCT01400841|Secondary|Mean Gradient - Change From Baseline|Transthoracic echocardiography parameter|Baseline, 6 months postprocedure|Baseline measure not available for 1 of 15 participants.|||mm Hg||Standard Deviation|Mean
2684231|NCT01369732|Secondary|Mortality|Participants will be followed for the mortality, an expected average of 1 month after surgery.|upto 1 month after surgery|||||||
2680514|NCT01400906|Primary|LAR - Non-smokers: Absolute Change From Saline in WM FEV1 Between 4-10 Hrs Following Post-treatment Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hour after dosing on Day 6. The WM FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. LAR WM FEV1 was measured at 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 6. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|PD Population. Only those participants were non-smokers were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
2680515|NCT01400906|Primary|LAR - Smokers: Absolute Change From Saline in Weighted Mean (WM) FEV1 Between 4-10 Hrs Following Post-treatment Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hour after dosing on Day 6. The WM FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. LAR WM FEV1 was measured at 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 6. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|PD Population. Only those participants who were smokers were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
2680516|NCT01400906|Primary|LAR - Non-smokers: Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 6. Minimum FEV1 over 4-10 hours post-allergen challenge is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|PD Population. Only those participants who were non-smokers were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
2680517|NCT01400906|Secondary|Concentration of Exhaled Nitric Oxide (eNO) on Day 6 and Day 7 of Each Treatment Period|The concentration of eNO was measured on Day 6 pre-dose and on Day 7 post-study medication administration. eNO was measured 3 times at each time point, and all 3 measurements were recorded. The mean of the 3 measurements was calculated and was used in the derivation of summary statistics.|Day 6 and Day 7 of each treatment period (up to 11 weeks)|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PD Population.|||Parts per billion||Standard Deviation|Mean
2680518|NCT01400906|Secondary|Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 7 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants inhaled doubling increments of methacholine until a >=20% decrease in FEV1 from the post-saline value was achieved.|Day 7 of each treatment period (up to 11 weeks)|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PD Population.|||milligrams per milliliter||95% Confidence Interval|Geometric Mean
2680519|NCT01400906|Secondary|Absolute Change From Baseline in FEV1 Post-dose on Day 1, Day 6 (Prior to Allergen Challenge), and Day 7|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline FEV1 was measured on Day 1 pre-dose administration. FEV1 was measured on Day 1 post-dose, on Day 6 (prior to allergen challenge), and on Day 7 pre dose administration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Baseline, Day 1, Day 6, and Day 7|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PD Population.|||Liters||95% Confidence Interval|Least Squares Mean
2680520|NCT01400906|Secondary|Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 and WM FEV1 Between 0-2 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 6. Minimum FEV1 over 0-2 hrs post-allergen challenge (Minimum EAR) is the minimum value of all of the post-allergen challenge timepoints up to and including 2 hours post-allergen challenge (i.e., minimum over 5 minutes [min], 10 min, 15 min, 20 min, 30 min, 45 min and 1 hr, 1.5 hrs, and 2 hrs). The WM FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PD Population.|||Liters||95% Confidence Interval|Least Squares Mean
2680521|NCT01400906|Primary|Late Asthmatic Response (LAR) - Smokers: Absolute Change From Saline in Minimum Forced Expiratory Volume in One Second (FEV1) Between 4-10 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 6. Minimum FEV1 over 4-10 hours post-allergen challenge is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.|Day 6 of each treatment period (up to 11 weeks)|Pharmacodynamic (PD) Population: all participants in the All Subjects Population (all participants who received at least one dose of study medication) who had a post-dose FEV1 assessment in the same period. Only those participants who were smokers were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
2680522|NCT01400893|Secondary|Renal Replacement Therapy Dependency at Day 60.|RRT dependency at day 60 is defined as patient not receiving any form of intermittent or continuous renal replacement therapy at 60 days post enrollment in the study with no plans for additional intermittent or continuous renal replacement therapy.|Day 60 following treatment initiation|per protocol.|||Participants|||Count of Participants
2680523|NCT01400893|Primary|The Primary Clinical Efficacy Endpoint in This Trial is All Cause Mortality Through 60 Days Post-randomization.|"All cause mortality through day 60 post-randomization.~The outcome data reported here describe the mortality at Day 60 (primary endpoint) of the treated subjects which received the recommended ionized calcium (riCa) for ≥ 90% of treatment time."|Day 60 following treatment initiation|Outcome data is reported for those subjects in which the calcium levels were maintained in the protocol's recommended range (≤0.4 mmol/L) for greater or equal to 90% of the therapy time.|||Participants|||Count of Participants
2680524|NCT01400880|Primary|Comparison of Electrode Sensor and TOCO Detection of Contraction Events, as Compared to IUPC|Contraction timing as measured by the electrode sensor and contraction timing as measure by the TOCO, both compared to the contraction timing as measured by the IUPC gold standard. The contraction timing values of the electrode sensor and TOCO were then compared.|Stage I and II Labor|Pregnant women between the ages of 18-50 with a single viable fetus in stages I and/or II of labor|||seconds||Standard Deviation|Mean
2680525|NCT01400841|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.|||l/min/m^2||Standard Deviation|Mean
2680526|NCT01400841|Secondary|Cardiac Index - Change From Baseline|Hemodynamic parameter computed as cardiac output divided by body surface area|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.|||l/min/m^2||Standard Deviation|Mean
2680527|NCT01400841|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.|||l/min||Standard Deviation|Mean
2680528|NCT01400841|Secondary|Cardiac Output - Change From Baseline|Stroke volume x heart rate. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.|||l/min||Standard Deviation|Mean
2680529|NCT01400841|Secondary|LVEF - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.|||percentage of blood volume||Standard Deviation|Mean
2680530|NCT01400841|Secondary|LVEF - Change From Baseline|Left ventricular ejection fraction. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.|||percentage of blood volume||Standard Deviation|Mean
2680531|NCT01400841|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.|||ml||Standard Deviation|Mean
2680532|NCT01400841|Secondary|LV Systolic Volume - Change From Baseline|Left ventricular systolic volume. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.|||ml||Standard Deviation|Mean
2680533|NCT01400841|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 5 of 11 participants.|||ml||Standard Deviation|Mean
2680534|NCT01400841|Secondary|LV Diastolic Volume - Change From Baseline|Left ventricular diastolic volume. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 7 of 15 participants.|||ml||Standard Deviation|Mean
2680535|NCT01400841|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 3 of 11 participants.|||cm||Standard Deviation|Mean
2680536|NCT01400841|Secondary|LVID Systole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 5 of 15 participants.|||cm||Standard Deviation|Mean
2680537|NCT01400841|Secondary|LVID Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 7 of 11 participants.|||cm||Standard Deviation|Mean
2680538|NCT01400841|Secondary|LVID Diastole - Change From Baseline|Left ventricular internal dimension. Transthoracic echocardiography parameter.|Baseline, 6 months postprocedure|Both baseline and 6-month measure available for 8 of 15 participants.|||cm||Standard Deviation|Mean
2680539|NCT01400841|Secondary|LV Mass - Change From Baseline|Left ventricular mass. Transthoracic echocardiography parameter.|Baseline, 2 years postprocedure (extended follow-up)|Both baseline and 2-year measure available for 6 of 11 participants.|||g||Standard Deviation|Mean
2680545|NCT01400841|Secondary|New York Heart Association (NYHA) Functional Capacity Classification|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|2 years postprocedure (extended follow-up)||||participants|||Number
2680546|NCT01400841|Secondary|New York Heart Association (NYHA) Functional Capacity Classification|Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort|6 months postprocedure|NYHA evaluation not done on 1 of 15 participants|||participants|||Number
2680547|NCT01400841|Secondary|Event-free Survival|Event-free survival is defined as survival free from device-related death|6 months postprocedure||||percentage of participants||95% Confidence Interval|Number
2680548|NCT01400841|Secondary|Actuarial Freedom From Clinical Cardiovascular Events|"Freedom from specified clinical cardiovascular events 2 years postprocedure:~Device-related mortality~Complete heart block~Structural device failure~Endocarditis~Periprosthetic leak or dehiscence~Thromboembolism~Bleeding Event~Native Valve Deterioration~Valve Thrombosis~Hemolysis~Reoperation and explant at 2 years"|2 years postprocedure||||percentage of implant procedures||95% Confidence Interval|Number
2680549|NCT01400841|Secondary|Actuarial Freedom From Clinical Cardiovascular Events|"Freedom from specified clinical cardiovascular events 1 month postprocedure:~Device-related mortality~Complete heart block~Structural device failure~Endocarditis~Periprosthetic leak or dehiscence~Thromboembolism~Bleeding Event~Native Valve Deterioration~Valve Thrombosis~Hemolysis~Reoperation and explant at 1 month"|1 month postprocedure||||percentage of implant procedures||95% Confidence Interval|Number
2680550|NCT01400841|Secondary|Implant Procedure Success|"Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure:~Aortic annular dissection, rupture, or leaflet damage~Paravalvular leak > +2 or requiring intervention~Mitral valve impingement due to implant~implant dehiscence/migration into aorta~implant dehiscence/migration into left ventricle~Hemodynamics requiring intervention~Other adverse event resulting in reoperation, explantation, or permanent disability."|2 years postprocedure (extended follow-up)||||percentage of implant procedures||95% Confidence Interval|Number
2680551|NCT01400841|Secondary|Implant Procedure Success|"Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure:~Aortic annular dissection, rupture, or leaflet damage~Paravalvular leak > +2 or requiring intervention~Mitral valve impingement due to implant~implant dehiscence/migration into aorta~implant dehiscence/migration into left ventricle~Hemodynamics requiring intervention~Other adverse event resulting in reoperation, explantation, or permanent disability."|discharge or 14 days postprocedure, whichever comes first||||percentage of implant procedures||95% Confidence Interval|Number
2680552|NCT01400841|Primary|Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure|Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)|2 years postprocedure (extended follow-up)||||participants|||Number
2680553|NCT01400841|Primary|Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure|Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)|6 months postprocedure||||participants|||Number
2680554|NCT01400841|Primary|Primary Safety Outcome Measure: Event-free Survival|Event-free survival is defined as survival free from device-related death|2 years postprocedure (extended follow-up)|Extended follow-up participants|||percentage of participants||95% Confidence Interval|Number
2680555|NCT01400841|Primary|Primary Safety Outcome Measure: Event-free Survival|Event-free survival is defined as survival free from device-related death|1 month postprocedure||||percentage of participants||95% Confidence Interval|Number
2680556|NCT01400698|Post-Hoc|Duration of Participation in the Study||Up to 10.6 years|ITT population included all participants enrolled in this study. Safety population was identical in this study. Here, ‘N’ (number of participants analyzed) signifies those participants who were evaluated for this measure.|||years||Standard Deviation|Mean
2680557|NCT01400698|Post-Hoc|Duration of Treatment||Up to 10.6 years|ITT population included all participants enrolled in this study. Safety population was identical in this study. Here, ‘N’ (number of participants analyzed) signifies those participants who were treated and hence, were evaluated for this measure.|||years||Standard Deviation|Mean
2680558|NCT01400698|Secondary|Parental Adjusted Height Standard Deviation Score (PAHSDS)|PAHSDS is the distance between the participant's current and target heights, expressed in units of SD of the height distribution of the reference population. Target height is a measure of the height which the participant could hypothetically reach based only on his parents' heights. Target height standard deviation score (THSDS) was calculated as target height minus mean adult height of the reference population divided by SD of the mean adult height of the reference population.|One year after final height was attained up to 10.6 years|ITT population included all participants enrolled in this study. Safety population was identical in this study.|||standard deviation score||Standard Deviation|Mean
2680559|NCT01400698|Primary|Height Standard Deviation Score (HSDS)|HSDS was calculated as height minus reference mean height divided by SD of the reference mean height, both given by the reference growth table (Sempe) for the corresponding chronological age at the height measurement. Greater HSDS indicate greater height. (Sempe M et al., 1979)|One year after final height was attained up to 10.6 years|ITT population included all participants enrolled in this study. Safety population was identical in this study.|||standard deviation score||Standard Deviation|Mean
2680560|NCT01400698|Primary|Final Height|Final height was defined as the height reached 1 year after height velocity (HV) was less than 2 centimeter/year (cm/year). Height velocity was the change in height since the previous year's measurement. Height was measured with a wall-mounted stadiometer (or in supine position if the participant's age was less than 3 years) and the measurement was repeated thrice by the same observer. The mean of the values obtained in the repeated measurements was taken for the analysis.|One year after final height was attained up to 10.6 years|Intention-to-treat (ITT) population included all participants enrolled in this study. Safety population was identical in this study.|||cm||Standard Deviation|Mean
2680561|NCT01400516|Secondary|Change From Baseline in Disease Activity Score 28 Joint Count C-Reactive Protein (DAS-28 CRP)|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and C-Reactive Protein (CRP) for a total possible score of 2 to 10. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.|Baseline and Month 12|Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.|||score on a scale||Standard Deviation|Mean
2680562|NCT01400516|Secondary|Change From Baseline in Bone Mineral Density (BMD) Measured by Dual-Energy X-ray Absorptiometry (DXA) and Instant Vertebral Assessment (IVA) Scan|BMD was measured at the lumbosacral spine antero-posterior and at the femoral neck using a densitometer. A positive change from Baseline (increased bone density) indicates improvement.|Baseline and Month 12|Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.|||grams/centimeters squared (g/cm^2)||Standard Deviation|Mean
2680563|NCT01400516|Primary|Change From Baseline in Joint Erosion Volume Measured by 3-Dimensional Computed Tomography (3D CT) Scan|Both hands were scanned using a CT scanner. A semi-automated software tool was used to segment the erosion margins in 3D. A board certified radiologist identified the individual erosions in six sub-regions: radius, ulna, proximal carpals, distal carpals, metacarpophalangeal (MCP) joints and proximal interphalangeal (PIP) joints. The average total in a single hand/wrist was calculated. A negative change from Baseline(less joint erosions) indicates improvement.|Baseline and Month 12|Analysis includes 24 participants who were randomized, 2 participants withdrew prematurely and are not included.|||cubic millimeter (mm^3)||Inter-Quartile Range|Median
2680564|NCT01400503|Secondary|Number of Participants Positive for Antibodies to Siltuximab|Serum samples were screened for antibodies binding to siltuximab and number of participants positive for antibodies to siltuximab was reported.|Up to 6 years|Safety analysis set included all enrolled participants in this study.|||Participants|||Count of Participants
2680565|NCT01400503|Secondary|Overall Survival|Overall survival was defined as the time between the first study siltuximab administration and death due to any cause. Kaplan-Meier method was used to estimate the overall survival.|Up to 6 years|Safety analysis set included all enrolled participants in this study.|||years||95% Confidence Interval|Median
2680566|NCT01400503|Secondary|Duration of Disease Control|Duration of disease control (DODC) was defined as the time from the first siltuximab administration in this study to disease progression as assessed by the investigator. Disease control was defined as stable or better response assessed by the investigators. Kaplan-Meier method was used to estimate the duration of disease control.|Up to 6 years|Safety analysis set included all enrolled participants in this study.|||years||95% Confidence Interval|Median
2680567|NCT01400503|Secondary|Percentage of Siltuximab-naive Participants Who Experienced Disease Control|Percentage of participants experiencing disease control was defined as the percentage of siltuximab-naïve participants who had stable or better response during the long-term safety extension based on investigator's judgment. Disease control was defined as stable or better response assessed by the investigators.|Up to 6 years|Population included subset of safety analysis set who were previously Siltuximab-naive i.e., received placebo in study CNTO328MCD2001 and never received siltuximab prior to enrollment in this study.|||percentage of participants|||Number
2680568|NCT01400503|Secondary|Percentage of Previously Responding Participants Who Maintained Disease Control|Percentage of participants maintaining disease control (defined as stable or better response) was defined as the percentage of previously responding participants who had not progressed during the long-term safety extension based on investigator assessment. A worsening in any of the measures will be considered as a progression of the disease.|Up to 6 years|Population included subset of safety analysis set who previously responded to siltuximab treatment ie, did not report disease progression while receiving siltuximab in study C0328T03 or CNTO328MCD2001.|||percentage of participants|||Number
2680569|NCT01400503|Primary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.|Up to 6 years|Safety analysis set included all enrolled participants in this study.|||Participants|||Count of Participants
2680570|NCT01400477|Secondary|Inhibition of Auditory Evoked Potential P50 to Repeated Stimuli|The P50 evoked response paired of auditory stimuli S1, S2, is measured. The inhibition is expressed as the ratio P50 S2 amplitude divided by P50 S1 amplitude.|4 weeks|Participants|||percentage of amplitude||Standard Deviation|Mean
2680571|NCT01400477|Primary|Neurocognitive Efficacy|MATRICS CCB Neurocognitive T-score (Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery Statistically Adjusted-score). Higher scores indicate better neurocognitive functionality.|4 weeks|participants|||MATRICS Neurocognitive T score||Standard Deviation|Mean
2680572|NCT01400451|Primary|Number of Participants With Hepatic Dose Limiting Toxicities (DLT) in Participants Treated With Concurrent Ipilimumab and Vemurafenib|DLT defined as a >= Grade 3 drug-related AE during induction with ipilimumab in combination with vemurafenib excluding: Grade 3 AE of tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor); Grade 3 cutaneous squamous cell carcinoma; Grade 3 photosensitivity that resolved to a Grade 1 or baseline within 15 days; Grade 3 immune-mediated events of the skin (rash, pruritis) or endocrine systems (hypothyroidism, hyperthyroidism, hypopituitarism, adrenal insufficiency, hypogonadism and cushingoid) that resolved to a Grade 1 or baseline within 28 days; a transient (resolving within 6 hours of onset) Grade 3 infusion-related AE. Hepatic=elevated aspartate aminotransferase and alanine aminotransferase. Maximum tolerable dose (MTD) was defined as the maximum dose of combination treatment that could be given to 6 subjects such that no more than 2 subjects experience DLT. Day 1=first day of concurrent therapy with ipilimumab and vemurafenib.|Day 1 to last dose of drug + 90 (approximately 2 years)|All participants who received at least one dose of concurrent study drugs.|||participants|||Number
2680581|NCT01400412|Secondary|Number of Participants Who Developed Grade 3 or 4 Primary Adverse Events|"Grade 3 or 4 primary adverse events includes primary signs/symptoms, primary laboratory abnormalities, or primary diagnoses.~See DAIDS AE Grading Table Version 1.0, Dec 2004 (Clarification, Aug 2009)"|From study treatment initiation to week 48|All participants who initiated study treatment|||participants|||Number
2680573|NCT01400451|Primary|During the Combination Treatment Period: Number of Participants With Adverse Events (AEs), AEs Leading to Drug Discontinuation, Serious Adverse Events (SAEs), and Deaths in Participants Treated With Concurrent Ipilimumab and Vemurafenib|AEs graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. AEs: onset on or after ipilimumab start and within 90 days of last dose. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Day 1=first dose of ipilimumab.|Combination drugs: Day 1 to last dose of drug + 90 days (approximately 2 years)|All participants who received at least one dose of study drug.|||participants|||Number
2680574|NCT01400451|Primary|During the Lead In Period: Number of Participants With Adverse Events (AEs), AEs Leading to Drug Discontinuation, Serious Adverse Events (SAEs), and Deaths in Participants Treated With Vemurafenib Alone|AEs graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling, Gr 5=Death. Related=relationship to study drug reported as certain, probable, possible, or missing. Immune-related AEs (irAEs) characterized by potential association with inflammation and considered by investigator as drug related. Lead In Period: between the first vemurafenib dose and the day prior to the first ipilimumab dose.|From first vemurafenib dose to day prior to first ipilimumab dose (28 days); Patients who never progressed from Lead-in to combination treatment (720 mg Alone): first dose to last dose + 90 days (approximately 2 years)|All participants who received at least one dose of study drug.|||participants|||Number
2680575|NCT01400425|Other Pre-specified|Percentage of Subjects Who Undergo a Hypothetical Change in Clinical Diagnosis After Obtaining a Florbetapir F 18 PET Scan.|The impact of a florbetapir F 18 PET scan on a physician's clinical diagnosis of a subject was evaluated on a hypothetical basis because at the start of this study Florbetapir F 18 was an investigational drug and the data collected is for research purposes only. The percentage of subjects who received a florbetapir scan that led to a change in hypothetical clinical diagnosis is presented below.|6 weeks|Subjects who have received a florbetapir scan (either positive or negative).|||Percentage of subjects||95% Confidence Interval|Number
2680576|NCT01400425|Secondary|Change in Physician Management Plans|Determine the percentage of subjects that had at least one hypothetical change between pre and post scan physician management plans. Change in management is defined as the number of subjects prescribed different item-wise plans at the two assessments divided by the total number of subjects in the population with both a pre and post florbetapir F 18 PET scan physician management plan.|6 weeks|All subjects with progressive cognitive decline who have received a florbetapir scan.|||Percentage of subjects||95% Confidence Interval|Number
2680577|NCT01400425|Secondary|Change in Confidence of the Clinical Diagnosis|Change in confidence of the clinical diagnosis prior to obtaining a florbetapir F 18 PET scan to the confidence after obtaining a florbetapir F 18 PET scan among subjects in whom the clinical diagnosis remains unchanged. Confidence levels were self-determined by physicians based on their diagnostic certainty and ranged from 0-100%. The mean (SD) change in confidence reflects the average change in diagnostic confidence along the 0-100% scale for the 62 subjects analyzed.|6 weeks|The hypothetical clinical diagnosis remained unchanged in 62 of 229 subjects who received a florbetapir scan.|||Percent Change in Confidence||Standard Deviation|Mean
2680578|NCT01400425|Other Pre-specified|Item Wise Changes in Physician Management Plan|This outcome analyzed the percentage of subjects who had a hypothetical change in one of the medication or diagnostic categories listed below after receiving a florbetapir scan.|6 weeks|The number of subjects analyzed for each reporting group is determined by scan status. There were 229 total subjects with progressive cognitive decline of whom 113 received a positive florbetapir scan and 116 received a negative florbetapir scan.|||Percentage of subjects|||Number
2680579|NCT01400425|Secondary|Percentage of Subjects Who Undergo a Hypothetical Change in Clinical Diagnosis and Physician Management Plan After Obtaining a Positive Florbetapir F 18 PET Scan|The impact of a positive florbetapir F 18 PET scan on a physician's clinical diagnosis and management of a subject was evaluated on a hypothetical basis because at the start of this study Florbetapir F 18 was an investigational drug and the data collected is for research purposes only. The percentage of subjects who received a positive florbetapir scan that led to a change in hypothetical clinical diagnosis and physician management plans are presented below. A positive florbetapir PET scan is indicative of moderate to frequent β-amyloid neuritic plaque density according to the modified Consortium to Establish a Registry for Alzheimer's Disease (CERAD) criteria.|6 weeks|113 out of 229 subjects with progressive cognitive decline received a positive florbetapir scan.|||Percentage of subjects||95% Confidence Interval|Number
2680580|NCT01400425|Primary|Percentage of Subjects Who Undergo a Hypothetical Change in Clinical Diagnosis and Physician Management Plan After Obtaining a Negative Florbetapir F 18 PET Scan.|The impact of a negative florbetapir F 18 PET scan on a physician's clinical diagnosis and management of a subject was evaluated on a hypothetical basis because at the start of this study Florbetapir F 18 was an investigational drug and the data collected is for research purposes only. The percentage of subjects who received a negative florbetapir scan that led to a change in hypothetical clinical diagnosis and physician management plans are presented below. A negative florbetapir PET scan is indicative of none to sparse β-amyloid neuritic plaque density according to the modified Consortium to Establish a Registry for Alzheimer's Disease (CERAD) criteria.|6 weeks|116 of 229 subjects with progressive cognitive decline received a negative florbetapir scan.|||Percentage of subjects||95% Confidence Interval|Number
2680582|NCT01400412|Secondary|Number of Participants Who Died During the Study||From study treatment initiation to week 48|All participants who started study treatment|||participants|||Number
2680583|NCT01400412|Secondary|Number of Participants Who Experienced Bone Fractures|Number of participants who experienced bone fractures during the study|From study treatment initiation to week 48|All participants who started study treatment|||participants|||Number
2680584|NCT01400412|Secondary|Cumulative Probability of Virologic Failure by Week 48|"Confirmed virologic failure is defined as confirmed plasma HIV-1 RNA levels > 1000 copies/mL at or after week 16 and before week 24, or confirmed HIV-1 RNA levels> 200 copies/mL at or after week 24. Participants who discontinued the study with an unconfirmed virologic failure (HIV-1 RNA > 1000 copies at 16 weeks or HIV-1 RNA level > 200 copies/mL at or after week 24) are considered as virologic failures at the study visit week of the unconfirmed value. Time to virologic failure is defined as the time from study entry to the planned visit week of the initial failure.~Product-limit estimates for the survival function were used to estimate the cumulative probability of virologic failure over time and its corresponding 95% confidence interval for each treatment group."|From study treatment initiation to week 48|All participants who started study treatment|||cumulative probability per 100 persons||95% Confidence Interval|Number
2680585|NCT01400412|Secondary|Change in Levels of D-dimer From Baseline||At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||ng/ml||Inter-Quartile Range|Median
2680586|NCT01400412|Secondary|Change in Levels of sCD14 From Baseline|Change in levels of soluble CD14 from baseline|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||ng/ml||Inter-Quartile Range|Median
2680587|NCT01400412|Secondary|Change in Levels of sCD163 From Baseline to Week 48|Change in levels of soluble CD163 from baseline to week 48|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||ng/ml||Inter-Quartile Range|Median
2680588|NCT01400412|Secondary|Change in Level of IP-10 From Baseline to Week 48|Change in level of Interferon gamma-induced protein 10 (IP-10) from baseline to week 48|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||pg/ml||Inter-Quartile Range|Median
2680589|NCT01400412|Secondary|Change in Levels of IL-6 From Baseline to Week 48|Change in levels of Interleukin 6 (IL-6) from baseline to week 48|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||pg/ml||Inter-Quartile Range|Median
2680590|NCT01400412|Secondary|Percent Change in Expression of RANKL+ on CD8+ T Cells From Baseline to Week 48|percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||percentage change||Inter-Quartile Range|Median
2680591|NCT01400412|Secondary|Percent Change in Expression of CD28+ on CD8+ T Cells From Baseline to Week 48|percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||percentage change||Inter-Quartile Range|Median
2680592|NCT01400412|Secondary|Percent Change in Expression of CD57+ on CD8+ T Cells From Baseline to Week 48|percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||percentage change||Inter-Quartile Range|Median
2680593|NCT01400412|Secondary|Percent Change in Expression of CD28+/CD57+ on CD8+ T Cells From Baseline to Week 48|percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||percentage change||Inter-Quartile Range|Median
2680594|NCT01400412|Secondary|Percentage Change in Expression of CD38+/HLA-DR+ on CD8+ T Cells From Baseline to Week 48|percentage change is defined as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||percentage change||Inter-Quartile Range|Median
2680595|NCT01400412|Secondary|Percentage Change in Expression of CD38+/HLA-DR+ on CD4+ T Cells From Baseline to Week 48|percentage change is define as [ (week 48 - week 0) / week 0 ] * 100%|At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||percentage change||Inter-Quartile Range|Median
2680596|NCT01400412|Secondary|CD8+ T-cell Change From Baseline to Week 48||At weeks 0 and 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||cell/mm^3||Inter-Quartile Range|Median
2680597|NCT01400412|Secondary|Change in CD4 Count From Baseline to Week 48|Change in CD4 count from baseline (week 0) to week 48|Week 0, week 48|Change in total CD4 count is analyzed in the same as-treated population as in the primary as-treated analysis.|||cells/mm^3||Inter-Quartile Range|Median
2682327|NCT01385306|Secondary|Time to Discharge From the Emergency Department|Time to discharge from the emergency department post stimulation|Duration of stay in emergency room - up to approximately 6 hours.|Safety population.|||minutes||Full Range|Mean
2680598|NCT01400412|Secondary|Change in CD4 Count From Baseline to Week 24|Change in CD4 count from baseline (week 0) to week 24|Week 0, week 24|Change in total CD4 count is analyzed in the same as-treated population as in the primary as-treated analysis.|||cells/mm^3||Inter-Quartile Range|Median
2680599|NCT01400412|Secondary|Percent Change in Lumbar Spine Bone Mineral Density (BMD)|The percent change in bone mineral density (BMD) at lumbar spine (as measured by DXA scan) from baseline (week 0) to week 48.|Week 0, week 48|As-treated analysis included only participants with available data at both baseline and week 48 who remained on their randomized MVC or TDF component by the time week 48 DEXA measurement was taken without an interruption of treatment for more than 10 weeks.|||percentage change||Inter-Quartile Range|Median
2680600|NCT01400412|Primary|Percent Change From Baseline in Total Hip Bone Mineral Density (BMD)|The primary endpoint is the percent change in bone mineral density (BMD) at total hip (as measured by DXA scan) from baseline (week 0) to week 48.|Week 0, week 48|The primary analysis was as-treated which included only participants with total hip BMD measurements available at both week 0 and week 48 who remained on their randomized MVC or TDF component by the time week 48 measurement was taken without an interruption of treatment of more than 10 weeks.|||percentage change||Inter-Quartile Range|Median
2680601|NCT01400243|Primary|POMS Vigor/Positive Affect (PA)|"Profile of Mood State questionnaire Vigor/Positive Affect scale. The potential range of the Vigor/Positive Affect scale is from 0 (no vigor) to 32 (maximally high vigor score)."|16 days (baseline through day 15 of treatment)||||units on a scale||Standard Error|Mean
2680602|NCT01400243|Primary|Marijuana Withdrawal Questionnaire (MWC) Total Score|"The Marijuana Withdrawal Questionnaire Total Score includes items assessing anxiety, depression, irritability, appetite, aggression/anger, sleep disturbance, somatic disturbances, and craving to use marijuana. The potential range of this total score is from 0 = no withdrawal symptoms to 47 = maximally high levels of withdrawal."|16 days (prequit baseline and at 1, 3, 5, 7, 9, 11, 13, and 15 days of abstinence)||||units on a scale||Standard Error|Mean
2680603|NCT01400243|Secondary|Diastolic Blood Pressure (DBP)|Diastolic blood pressure measured during each of the experimental sessions-- baseline through 15-days post-quit.|From baseline to Day 15 of abstinence||||mm Hg||Standard Error|Mean
2680604|NCT01400243|Secondary|Heart Rate|Heart rate measured during laboratory assessment sessions.|Baseline through Day 15 of abstinence||||beats per minute||Standard Error|Mean
2680605|NCT01400243|Secondary|Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml.|Tetrahydrocannabinol (THC) Intake assessed by assessing urine sample creatinine corrected THC in ng/ml urine.|across baseline and at 3, 5, 7, 9, 11, 13, and 15 days of abstinence||||ng/ml urine creatinine-corrected THC||Standard Error|Mean
2680606|NCT01400243|Secondary|Tobacco and Nicotine Intake|Nicotine intake was assessed by self-reported tobacco cigarettes per month (30 days) at baseline (prior to treatment) and also across the 30 days starting immediately after the end of treatment.|Basesline 30 days prior to study and during the 30 days following the 15-day abstinence phase.||||Cigarettes per 30 days||Standard Error|Mean
2680607|NCT01400243|Secondary|Systolic Blood Pressure (SBP)|Systolic blood pressure was measured in mmHg during each experimental session prior and subsequent to quitting marijuana.|From baseline to Day 15 of abstinence||||mmHg||Standard Error|Mean
2680608|NCT01400243|Secondary|Patch Guess and Attributions Questionnaire|The Patch Guess and Attributions Questionnaire assesses which type of patch (active versus placebo) the subject believes that he or she was given during the study. This assessment was made at end of treatment (Day 15 of abstinence), the last day on a patch. Scores range from 0 percent to 100 percent chance of being on the nicotine patch for those actually on the placebo patch and from 0 percent to 100 percent chance of being on the nicotine patch for those subjects actually on the nicotine patch. Each subject was asked to indicate the percentage chance that he or she was on the nicotine (as opposed to the placebo) patch. The mean values reported below are the group mean percentage averages.|Day 15 of abstinence||||Percentage chance on nicotine patch||Standard Error|Mean
2680609|NCT01400243|Primary|Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)|"POMS Total negative affect was assessed during the final pre-quit baseline session and the 8 post-quit sessions (1, 3, 5, 7, 9, 11, 13, and 15 days post-quit). The Total negative affect score has a minimum potential value of 0 = best possibly level and a maximum value of 154 = worst possible level."|16 days (prequit baseline and 15 days of abstinence)||||units on a scale||Standard Error|Mean
2680610|NCT01400139|Secondary|Treatment Satisfaction Questionnaire (TSQ) - Part II|The TSQ is a self-administered questionnaire that consists of 2 parts. Part II has 2 questions that measure the subject's willingness to continue the use of study drug as pain medication (Q1), and to recommend the study drug to someone else (Q2). Question 1 consists of 6 categories of response rated on a scale from 1 (very willing to continue) to 6 (very unwilling to continue): 1=Very willing to continue; 2=Willing to continue; 3=Somewhat willing to continue; 4=Somewhat unwilling to continue; 5=Unwilling to continue; 6=Very unwilling to continue. Question 2 consists of 3 categories of response: 1=yes; 2=no; 3=undecided. The number of subjects with each category of response for each individual question was summarized for subjects completing the core study maintenance period and for those enrolled in the extension period.|At Week 52 or upon early discontinuation at or before Week 4 in maintenance and at Week 24 in extension|The Core Study population analyzed was the group of subjects who received at least 1 dose of study drug during the maintenance period and provided data. The Extension Period safety population was the group of core study safety population subjects who entered the extension period and received at least 1 dose of study drug in the extension period.|||participants|||Number
2680618|NCT01400139|Primary|The Number of Participants With Adverse Events as a Measure of Safety|Safety assessments included AEs, clinical laboratory test results, vital sign measurements, ECG findings, and audiology assessments.|Up to 84 weeks|The Core Study safety population (N=922) was defined as the group of subjects who received at least 1 dose of study drug during the study. The Extension Period safety population (N=106) was the group of core study safety population subjects who entered the extension period and received at least 1 dose of study drug in the extension period.|||participants|||Number
2680619|NCT01400113|Secondary|Clinical Global Impression Scale|Secondary outcome measures will include the Clinical Global Impression -Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scales.|2 hours|||||||
2682730|NCT01381679|Secondary|Change From Baseline in TG at Month 12||Baseline and Month 12|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG.|||mg/dL||95% Confidence Interval|Mean
2680611|NCT01400139|Secondary|Treatment Satisfaction Questionnaire (TSQ) - Part I|The TSQ is a self-administered questionnaire that consists of 2 parts. Part I has 6 questions (Q1 to Q6) that ask the subject to rate the experience with use of the study drug in comparison to the prestudy pain medication regarding ease of use, convenience, frequency, pain control, and overall satisfaction. Each question was rated on a scale from 1 (extremely satisfied) to 6 (extremely dissatisfied): Q1=Satisfaction with study drug; Q2=Ease of study drug use to treat pain; Q3=Convenience of study drug to treat pain; Q4=Overall drug satisfaction managing pain; Q5=Satisfaction with frequency of use; Q6=Ease of planning study drug use. The number of subjects with each category (1-6) of response for each individual question (Q1-Q6) was summarized for subjects who entered the core study maintenance period and responded to each question. TSQ - Part I was not administered in the extension period.|At Week 52 or upon early discontinuation at or before Week 4 in the Core Study maintenance period|The Core Study population analyzed was the group of subjects who received at least 1 dose of study drug during the maintenance period and provided data.|||participants|||Number
2680612|NCT01400139|Secondary|Patient Global Impression of Change (PGIC)|The PGIC is an ordinal scale of global evaluation that assesses the change in overall status relative to the start of the study. The scale has only 1 item that measures global change of overall status (improvement or worsening) by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse.|At Week 52 in the Core Study maintenance period and at Week 24 in the Extension Period|The Core Study population analyzed was the group of subjects who received at least 1 dose of study drug during the study. The Extension Period safety population was the group of core study safety population subjects who entered the extension period and received at least 1 dose of study drug in the extension period.|||participants|||Number
2680613|NCT01400139|Secondary|Medical Outcomes Study 36-item Short Form (SF-36)|The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the subject's perspective. The 36 questions are grouped into 11 sections. Some of the sections consist of multiple questions. The survey is summarized into 8 dimensions/scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. From the 8 health dimensions, physical component summary, and mental component summary measures are derived. Scores on each scale ranged from 0 to 100; a higher score indicates a better perception of health.|Up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period|The Core Study population analyzed was the group of subjects who received at least 1 dose of study drug during the maintenance period and provided data. The Extension Period safety population was the group of core study safety population subjects who entered the extension period and received at least 1 dose of study drug in the extension period.|||units on a scale||Standard Deviation|Mean
2680614|NCT01400139|Secondary|Brief Pain Inventory Short Form (BPI-SF)|"The BPI-SF assessed the severity of pain and interference of pain on daily functions. It consists of 9 sections denoted by Q1 to Q8 and Q9A to Q9G according to their order in the questionnaire, that measure pain location, intensity, pain treatment, and functional interference of pain on mood and every day activities. Scores ranged from 0 (none) to 10 (worst as can be). Four of the items (questions 3 to 6) assess severity of pain and 7 items (questions 9A to 9G) assess interference of pain. The pain interference subscale score was determined by calculating the mean of responses to Q9A - Q9G [Q9A (general activity), Q9B (mood),Q9C (walking), Q9D (working), Q9E (relations with others), Q9F (sleep), and Q9G (enjoyment of life)] and the severity of pain subscale score was determined by calculating the mean of responses to Q3 - Q6 [Q3 (worst pain in last 24 hours), Q4 (least pain in last 24 hours), Q5 (average pain), and Q6 (pain right now)]. A lower score indicates lower pain."|Up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period|The Core Study population analyzed was the group of subjects who received at least 1 dose of study drug during the maintenance period and provided data. The Extension Period safety population was the group of core study safety population subjects who entered the extension and received at least 1 dose of study drug in the extension period.|||units on a scale||Standard Deviation|Mean
2680615|NCT01400139|Secondary|Medical Outcomes Study (MOS) Sleep Scale - Revised (MOS Sleep-R)|The MOS Sleep-R is a brief, self-administered 12-item assessment designed to measure key aspects of sleep. It includes a sleep problems index II and 6 subscale scores - sleep disturbance, sleep adequacy, daytime somnolence, snoring, awaken short of breath or with headache, and quantity of sleep. For each individual and time of assessment, quantity of sleep was recorded as the number of hours slept per night. The number of hours it took the subject to fall asleep per night was categorized 1, 2, 3, 4, or 5 corresponding to 0 through 15, 16 through 30, 31 through 45, 46 through 60, or more than 60 minutes, respectively. The other scales were recorded as 1 = all of the time, 2 = most of the time, 3 = some of the time, 4 = a little of the time, or 5 = none of the time. A higher value indicates a better score, therefore a positive change from baseline indicates a better sleep pattern and a negative change from baseline indicates a worsening in sleep pattern.|Baseline and up to 52 weeks in the Core Study maintenance period, and up to 24 weeks in the Extension Period|The Core Study population analyzed was the group of subjects who received at least 1 dose of study drug during the maintenance period and provided data. The Extension Period safety population was the group of core study safety population subjects who entered the extension and received at least 1 dose of study drug in the extension period.|||units on a scale||Standard Deviation|Mean
2680616|NCT01400139|Secondary|"Pain Right Now Score"|"Pain right now scores were collected using an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. The pain right now scores were only collected during the Core Study. Pain right now scores were not assessed during the Extension Period."|Week 12|The Core Study population analyzed was the group of subjects who received at least 1 dose of study drug during the maintenance period and provided data. Data were not collected for this outcome measure during the Extension Period.|||units on a scale||Standard Error|Mean
2680617|NCT01400139|Primary|"Daily Average Pain Over the Last 24 Hours"|"Average pain over the last 24 hours score (on an 11-point numerical rating scale where 0 = no pain and 10 = pain as bad as you can imagine)."|Core study: from start to end of maintenance period (up to 52 weeks); Extension study: from start of maintenance to end of extension (up to 76 weeks)|The Core Study population analyzed (N=727) was the group of subjects who received at least 1 dose of study drug during the maintenance period. The Extension Period population analyzed (N=106) was the group of core study safety population subjects who entered the extension period and received at least 1 dose of study drug in the extension period.|||units on a scale||Standard Deviation|Mean
2680620|NCT01400113|Primary|Positive and Negative Syndrome Scale - Excited Component|The primary outcome measure is change in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) from baseline to 2 hours after medication administration. The PANSS-EC consists of 5 items: excitement, tension, hostility, uncooperativeness, and poor impulse control. The 5 items from the PANSS-EC are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation. This set of items detects differences between drug and placebo when evaluating acute agitation and aggression in psychiatric patients with different psychiatric pathologies.|Change in PANSS-EC score from baseline to 2 hours post drug/placebo administration.||||PANSS SCORE||95% Confidence Interval|Mean
2680621|NCT01399905|Secondary|AUC of Levodopa Plasma Concentrations Above Baseline|Baseline value is levodopa concentration at 9 AM. AUC is calculated as levodopa concentrations minus 9 AM value at 30 minute intervals until 2 PM.|Measured every 30 minutes from 9 AM until 2 PM|The levodopa plasma samples of one subject were accidently thawed so samples from 11 participants were used in this data analysis.|||(µg/ml)*(hours)||Standard Deviation|Mean
2680622|NCT01399905|Primary|Area Under the Curve (AUC) of Tapping Speed|"Tapping speed is an index of bradykinesia and is used as a response to levodopa infusion.~Reported as increase over average of three measurements between 8 AM and 9 AM (baseline tapping speed) as (taps/min)*(hours) for tapping scores from beginning of levodopa infusion to 3 hours after conclusion of levodopa infusion."|Performed every 30 minutes from 8 AM to 2 PM|All 12 participants who completed the study were included in the data analysis. Each arm contains data from all 12 participants because this is a cross-over study. All participants participated in both the high-dose and low-dose carbidopa arms.|||(taps/min)*(hours)||Standard Deviation|Mean
2680623|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Attentional Bias Toward Smoking Cuesmeasured With the Emotional Stroop Task|Recently abstinent smokers assigned to receive D-cycloserine + CET will have less attentional bias (Smoking Stroop task) toward smoking cues at the Post-Extinction Assessment than those who receive placebo + CET The Emotional Stroop uses smoking-related words and neutral words to measure attentional bias toward smoking related cues. Attentional bias is a central feature of many cognitive theories of addiction and can be measured with an emotional analog of the Stroop task. In this task, participants name the colors in which words are printed, and the words vary in their relevance to smoking. Extensive research has shown that patients are often slower to name the color of a word associated with concerns relevant to their clinical condition due to distraction by the meaning of the word(Williams, Mathews et al. 1996). The Stroop interference Score is obtained by subtracting Reaction Time (RT) to smoking minus the Reaction Time to neutral|Baseline and week 6||||Stroop interference Score||Standard Deviation|Mean
2680624|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Craving|Recently abstinent smokers assigned to receive D-cycloserine + CET will have less craving at the Post-Extinction Assessment than those who receive placebo + CET The scale used to measure craving was a Visual Analogue Scale 0 (no desire at all) - 7 (unable to resist) Subjects were presented with 2 blocks of audio recordings, one smoking-related script and one neutral script unrelated to smoking. Craving level was obtained after each audio recording was presented. The craving mean was obtained for each script (smoking vs neutral). Differences in craving level response to smoking cues (smoking script) was compared between subjects who received D-cycloserine + CET and subjects who received placebo + CET.|6 weeks||||change in units on a scale||Standard Deviation|Mean
2680625|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Electromyogram|"Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (electromyogram) reactivity to smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.~Subjects were presented with 2 blocks of audio recordings, one smoking-related script and one neutral script unrelated to smoking. Electromyogram of the corrugator (EMGc)measurement was obtained after each audio recording was presented. The EMGc mean was obtained for each script (smoking vs neutral). Differences in responsivity (EMGc) to smoking cues (smoking script) was compared between subjects who received D-cycloserine + CET and subjects who received placebo + CET."|6 weeks||||change in micro volts||Standard Deviation|Mean
2680626|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Heart Rate|"Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (heart rate) reactivity to smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.~Subjects were presented with 2 blocks of audio recordings, one smoking-related script and one neutral script unrelated to smoking. Heart rate measurement was obtained after each audio recording was presented. The heart rate mean was obtained for each script (smoking vs neutral). Differences in responsivity (heart rate) to smoking cues (smoking script) was compared between subjects who received D-cycloserine + CET and subjects who received placebo + CET."|6 weeks||||change in beats per minute||Standard Deviation|Mean
2680627|NCT01399866|Secondary|Effect of D-cycloserine + Cue-exposure Treatment on Skin Conductance|"Recently abstinent smokers assigned to receive D-cycloserine + CET will have less physiologic (skin conductance) reactivity to smoking cues at the Post-Extinction Assessment than those who receive placebo + CET.~Subjects were presented with 2 blocks of audio recordings, one smoking-related script and one neutral script unrelated to smoking. Assessment of skin conductance was made after each audio recording was presented. The skin conductance mean was obtained for each script (smoking vs neutral). Differences in responsivity (skin conductance) to smoking cues (smoking script) was compared between subjects who received D-cycloserine + CET and subjects who received placebo + CET."|6 weeks||||change in microSiemens||Standard Deviation|Mean
2680628|NCT01399866|Primary|Effect of D-cycloserine + Cue-exposure Treatment on Continuous Abstinence From Tobacco Smoking.|Participants assigned to receive D-cycloserine + CET will achieve better maintenance of tobacco abstinence, as assessed with self-report and saliva cotinine measurements, than those who receive placebo + CET at week 6 follow up visits|Up to 6 weeks||||percentage of participants|||Number
2680629|NCT01399827|Secondary|Efficacy Measured by Mean Change From Baseline to Endpoint on the Global Assessment of Functioning (GAF) Scale|The Global Assessment of Functioning (GAF) scale is used to rate how serious a mental illness may be. Lower scores on this scale indicate a lower level of functioning and higher severity of symptoms. Total scores range from 0 to 100.|baseline to 12 weeks||||units on a scale|||Number
2680684|NCT01399099|Secondary|Comparison of Scar Smoothness of Treated Side as Compared to the Control Side||Up to 12 months|||||||
2680685|NCT01399099|Secondary|Comfort Level Related to Study Device Application, Wear and Removal||Up to 12 weeks|||||||
2680630|NCT01399827|Secondary|Efficacy Measured by Mean Change From Baseline to Endpoint on BRIEF-A Subscales|The BRIEF-A is a 75-item questionnaire that assesses and adult's cognitive, emotional, and behavioral functions within the past month. The subject rates each question on a 3-point scale (1=Never, 2=Sometimes, 3=Often). Raw scores are calculated and used to generate T-scores for 8 scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials), 2 summary index scales (Behavioral Regulation Index and Metacognition Index), and one scale reflecting overall functioning (Global Executive Composite). T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement.|baseline to 12 weeks||||units on a scale|||Number
2680631|NCT01399827|Secondary|Efficacy Measured by Mean Change From Baseline to Endpoint on Clinical Global Impression (CGI) Scale|The Clinical Global Impression (CGI) is a 3-item observer-rated scale that measures illness severity (CGIS), global improvement or change (CGIC) and therapeutic response (CGIE). Scores range from 0 to 7 on each subscale. Total scores range from 0 to 21. T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement.|baseline to 12 weeks||||T-Score|||Number
2680632|NCT01399827|Secondary|Efficacy Measured by Mean Change From Baseline to Endpoint on Adult ADHD Investigator Rating Scale (AISRS) Total Score|"The Adult ADHD Investigator Rating Scale (AISRS) measures ADHD symptoms in adults. This scale is an investigator rated scale. Higher scores on this scale indicate more severe ADHD-like symptoms. Patients symptoms are rated as never, rarely, sometimes, often, or very often by the investigator. Total score ranges from 0 to 54. T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement."|baseline to 12 weeks||||T-Score|||Number
2680633|NCT01399827|Primary|Mean Change From Baseline to Endpoint on the BRIEF-A Emotional Control Scale|The BRIEF-A is a 75-item questionnaire that assesses and adult's cognitive, emotional, and behavioral functions within the past month. The subject rates each question on a 3-point scale (1=Never, 2=Sometimes, 3=Often). Raw scores are calculated and used to generate T-scores for 8 scales (Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials), 2 summary index scales (Behavioral Regulation Index and Metacognition Index), and one scale reflecting overall functioning (Global Executive Composite). T-scores range from 30 to 100, with scores ≥65 indicating clinical impairment. A reduction in score indicates improvement.|Baseline to 12 weeks||||T-Score|||Number
2680634|NCT01399788|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose for rifampicin, isoniazid and ethambutol and additional 36 and 48 hrs post-dose for pyrazinamide|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.|||hr||Full Range|Median
2680635|NCT01399788|Secondary|Plasma Decay Half-life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose for rifampicin, isoniazid and ethambutol and additional 36 and 48 hrs post-dose for pyrazinamide|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period. Here, 'n' is number of participants who were evaluable for this measure.|||hr||Standard Deviation|Mean
2680636|NCT01399788|Secondary|Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞][dn]) for Pyrazinamide|AUC [0-∞][dn] = Dose normalized area under the plasma concentration versus time curve (AUC[dn]) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-∞) divided by dose and then multiplied by 1500. The test and reference for pyrazinamide were given at different doses, so dose-normalized parameters were used for analysis for adjusting the dose effect on bioequivalence conclusion.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.|||(ng*hr/mL)/mg||Standard Deviation|Geometric Mean
2680637|NCT01399788|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0-∞])|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period. Here, 'n' is number of participants who were evaluable for this measure.|||ng*hr/mL||Standard Deviation|Geometric Mean
2680638|NCT01399788|Primary|Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) for Pyrazinamide|It is obtained from Cmax divided by dose and then multiplied by 1500. The test and reference for pyrazinamide were given at different doses, so dose-normalized parameters were used for analysis for adjusting the dose effect on bioequivalence conclusion.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.|||(ng/mL)/mg||Standard Deviation|Geometric Mean
2680639|NCT01399788|Primary|Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) for Pyrazinamide|AUClast[dn] = Dose normalized area under the plasma concentration-time curve (AUC[dn]) from time zero (pre-dose) to the time of last measured concentration. It is obtained from AUClast divided by dose and then multiplied by 1500. The test and reference for pyrazinamide were given at different doses, so dose-normalized parameters were used for analysis for adjusting the dose effect on bioequivalence conclusion.|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.|||(ng*hr/mL)/mg||Standard Deviation|Geometric Mean
2680640|NCT01399788|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
2680686|NCT01399099|Secondary|Ease of Use||Up to 12 months|||||||
2680641|NCT01399788|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration-time curve from time zero (pre-dose) to the time of last measured concentration (AUClast).|0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours (hrs) post-dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2680642|NCT01399723|Secondary|Outcome (Death/Readmission) at 14 Days as Determined by Telephone or Direct Interview|Definition of death as described in third secondary outcome measure.|Day 14||||participants|||Number
2680643|NCT01399723|Secondary|Death at or Before Five Days Following Enrollment|Death defined as: in-hospital death occurring at any time after randomisation (recruitment for HIV-exposed participants) or verbal report of death of the enrolled patient from parent/guardian communicated either directly or via telephone conversation.|Day 0 to Day 5|||||||
2680644|NCT01399723|Secondary|Readmission With Diagnosis of Severe or Very Severe Pneumonia Within 14 Days of Enrollment||Day 0 to Day 14|||||||
2680645|NCT01399723|Secondary|Treatment Failure at or Before Discharge / Day 5 Post Enrollment (Whichever Occurs First)|Treatment failure as defined in the primary outcome measure.|Patients will be followed up from the day of hospitalisation (day 0) until the day of medical discharge (average duration of 3 days) or until day 5 of hospitalisation (whichever occurs first).|Intention to treat analysis|||participants|||Number
2680646|NCT01399723|Primary|Treatment Failure at 48 Hours (Two Full Days After Enrollment)|Development of any signs of very severe pneumonia at any time Hypoxemia defined as SpO2 <85% or <80% for altitude < or ≥1500m respectively measured after minimum of 3 minutes on ambient air Persistent vomiting (occurring within 30 minutes of administration of amoxicillin with failure to retain drug after 3 successive attempts at administration) at any time Clinical diagnosis of new bacterial co-morbid condition requiring revision of antibiotic treatment at any time Lower chest wall indrawing Temperature ≥38◦C Respiratory rate ≥5bpm of admission rate if above age-adjusted normal upper limit|48 hours|Intention to treat analysis|||participants|||Number
2680647|NCT01399697|Secondary|Change From Week 16 to Week 28 in Global Assessment of Disease Activity Assessed Using the VAS Performed by the Investigator|Participants were asked to rate their global assessment of disease activity on a scale ranging from 0=very good to 100=very bad. The scale was represented by a line with 0 at the left edge and 100 at the right edge. The participant was asked to mark the line corresponding to the assessment of their disease activity. The distance from the left edge was measured in mm.|Week 16 and Week 28|ITT Population; only participants with non missing values were included in the analysis.|||units on a scale||Standard Deviation|Mean
2680648|NCT01399697|Secondary|Change From Week 16 to Week 28 in Global Assessment of Disease Activity as Assessed With the Visual Analogue Scale (VAS) Performed by Participant|Participants were asked to rate their global assessment of disease activity on a scale ranging from 0=very good to 100=very bad. The scale was represented by a line with 0 at the left edge and 100 at the right edge. The participant was asked to mark the line corresponding to the assessment of their disease activity. The distance from the left edge was measured in mm.|Week 16 and Week 28|ITT Population; only participants with non missing values were included in the analysis.|||units on a scale||Standard Deviation|Mean
2680649|NCT01399697|Secondary|Change in the Quality of Life Questionnaire (SF-12) From Week 16 to Week 28 in Physical Health|Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. A negative change from baseline indicated a worsening of quality of life.|Week 16 and Week 28|ITT Population; only participants with non missing data were included in the analysis.|||units on a scale||Standard Deviation|Mean
2680650|NCT01399697|Secondary|Change in the Quality of Life Questionnaire (Short Form-12 [SF-12]) From Week 16 to Week 28 in Mental Health|Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. A negative change from baseline indicated decline in health and higher scores indicated improvement in health.|Week 16 and Week 28|ITT Population; only participants with non missing values were included in the analysis.|||units on a scale||Standard Deviation|Mean
2680651|NCT01399697|Secondary|Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Week 16 to Week 28|HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.|Week 16 and Week 28|ITT Population; only participants with non missing values were included in the analysis.|||units on a scale||Standard Deviation|Mean
2680652|NCT01399697|Secondary|Percentage of Participants With Simplified Disease Activity Index (SDAI) <3.3 at Week 28|SDAI is calculated by a simple numerical sum of tender and swollen joint count (based on a 28-joint assessment), participant and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligram per deciliter (mg/dL). SDAI total score 0-86; higher scores = greater affect due to disease activity. SDAI <3.3 = clinical remission.|28 weeks|ITT Population; only participants with SDAI scores at Week 28 were included in the analysis.|||percentage of participants|||Number
2680653|NCT01399697|Secondary|Percentage of Participants With Clinical Disease Activity Index (CDAI) <2.8 at Week 28|CDAI is the sum of tender and swollen joint count based on 28 joints and the participant and physician global disease assessment (VAS 0-10 centimeters [cm]). CDAI total score 0-76; higher scores = greater affect due to disease activity. CDAI <2.8 = clinical remission.|Week 28|ITT Population; only participants with CDAI scores at Weeks 28 were included in the analysis.|||percentage of participants|||Number
2680687|NCT01399099|Secondary|Subject and Investigator Satisfaction With the Aesthetic Results||Up to 12 months|||||||
2680709|NCT01398956|Secondary|The Incidence of Adverse Drug Reactions During the Entire Study Period|Adverse drug reactions excludes Adverse Events (AEs) described by the investigators with no relationship to study drug.|Through study completion, an average of 3 years|The Safety Set (SS) consisted of all subjects who took at least one dose of study medication in this study.|||Adverse Drug Reactions|||Number
2680654|NCT01399697|Secondary|Percentage of Participants With DAS28 Score Less Than (<) 2.6 at Week 28|The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 <2.6 equals (=) remission.|Week 28|ITT Population; only participants with Week 28 DAS28 values were included in the analysis.|||percentage of participants|||Number
2680655|NCT01399697|Primary|Change in Disease Activity Score Based on 28-Joint Count (DAS28) From Week 16 to Week 28|The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate [ESR] in millimeters per hour [mm/hr]), and general health status (participant global assessment of disease activity using visual analog scale [VAS], range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.|Baseline, Week 16, and Week 28|Intent-to-treat (ITT) population: all randomized participants who received at least one dose of study medication and who had at least one efficacy measurement performed.|||units on a scale||Standard Deviation|Mean
2680656|NCT01399619|Secondary|The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no|The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=no. BL = baseline.|60 weeks|FAS|||participants|||Number
2680657|NCT01399619|Secondary|The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes|The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=yes. BL = baseline.|60 weeks|FAS|||participants|||Number
2680658|NCT01399619|Secondary|The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no|The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=no. BL = baseline.|48 weeks|FAS|||participants|||Number
2680659|NCT01399619|Secondary|The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes|The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=yes. BL = baseline.|48 weeks|FAS|||participants|||Number
2680660|NCT01399619|Secondary|The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no|The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=no. BL = baseline.|60 weeks|FAS|||participants|||Number
2680661|NCT01399619|Secondary|The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes|The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=yes. BL = baseline.|60 weeks|FAS|||participants|||Number
2680662|NCT01399619|Secondary|The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no|The number of participants with Alanine Aminotransferase (ALT) normalisation: ALT in normal range at End of Treatment when SVR12=no. BL stands for baseline.|48 weeks|FAS|||participants|||Number
2680663|NCT01399619|Secondary|The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes|The number of participants with Alanine Aminotransferase (ALT) normalisation at End of Treatment (EoT) when SVR12=yes. BL stands for baseline.|48 weeks|FAS|||participants|||Number
2680664|NCT01399619|Secondary|Early Treatment Success (ETS)|Early Treatment Success (ETS): Plasma HCV RNA level<25 IU/mL (detected or undetected) at Week 4 and HCV RNA< 25 IU/mL, undetected at Week 8|Week 4, week 8 and week 60|FAS|||participants|||Number
2680665|NCT01399619|Secondary|Virological Response 24 Weeks Post Treatment (SVR24)|Percentage of participants with virological response 24 weeks post treatment (SVR24): Plasma HCV RNA level<25IU/mL (undetected) 24 weeks after the planned end of treatment.|72 weeks|FAS|||percentage of participants||95% Confidence Interval|Number
2680666|NCT01399619|Primary|Sustained Virological Response (SVR12)|Percentage of participants with sustained Virological Response SVR12: Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level <25 IU/mL, undetected 12 weeks after the planned end of treatment.|60 weeks|FAS|||percentage of participants||95% Confidence Interval|Number
2680667|NCT01399593|Primary|Treatment Failure Rate|The primary efficacy variable was a binary outcome variable where patients meeting the composite endpoint of the occurrence of 1) biopsy-proven acute AMR, 2) graft loss, 3) patient death, or 4) loss to follow-up definition at Week 9 post-transplantation were considered treatment failures and all others were considered treatment successes.|9 weeks post-transplantation|Full analysis set, defined as patients who were randomized, received a living donor kidney transplant, and were treated (either with eculizumab or SOC), based on randomized treatment groups.|||Participants|||Count of Participants
2680668|NCT01399268|Secondary|Ability to Ambulate||48 hours||||Participants|||Count of Participants
2680669|NCT01399268|Secondary|Mortality||Length of hospital stay, an expected average of 5 days||||Participants|||Count of Participants
2680670|NCT01399268|Secondary|In Hospital Infection Rate||Length of hospital stay, an expected average of 5 days||||Participants|||Count of Participants
2680671|NCT01399268|Secondary|Length of Hospital Stay||Length of hospital stay, an expected average of 5 days||||days||Standard Deviation|Mean
2680672|NCT01399268|Secondary|Blood Glucose||24 hours postoperative||||mg/dL||Standard Deviation|Mean
2680673|NCT01399268|Secondary|Desmosine Level||24 hours postoperative|Data were not collected||||||
2680674|NCT01399268|Primary|Decrease in IL6 Level||24 hours postoperative||||pg/ml||99% Confidence Interval|Mean
2680675|NCT01399229|Primary|Comparison of SureCALL® and Tocodynamometer Detection of Contraction Event Timing|Time Stamps of the Peaks of Corresponding Contractions|9 - 41 Minutes||||Seconds||Standard Deviation|Mean
2680676|NCT01399190|Secondary|Percentage of Participants With Adverse Events|An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Up to approximately 30 months|Includes enrolled participants eligible for inclusion in the final analysis.|||percentage of participants|||Number
2680677|NCT01399190|Secondary|Response Rate (Tumor Assessments According to RECIST)|Response to treatment (Response Rate) was defined as the percentage of participants with a complete remission (CR) or partial remission (PR), and was assessed by the investigators according to modified RECIST criteria. CR was defined as disappearance of all lesions. PR was defined as a decrease in sum of lesions size by more than 30%. Response Rate = CR +PR|Up to approximately 30 months|Includes enrolled participants who were evaluable for the primary endpoint analysis.|||percentage of participants|||Number
2680678|NCT01399190|Primary|Progression-free Survival|Progression-free survival was defined as the interval between the day of first treatment and the first documentation of disease progression or death and was assessed by the investigators according to modified Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was defined as an increase in sum of lesions size by more than 20% or new lesions.|From randomization to progression or death during the study (up to approximately 30 months)|Includes enrolled participants who were evaluable for the primary endpoint analysis.|||months||95% Confidence Interval|Median
2680679|NCT01399125|Secondary|Change From Baseline in Mini-Mental State Examination (MMSE) Total Score|The Mini-Mental State Examination (MMSE) was used to establish patient's eligibility for the study and it was also used as an efficacy parameter in the Double-blind Treatment Period. The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 30, with higher scores indicating betterfunction. The total MMSE score at screening was between 10 and 20, inclusive, in order forthe patient to be eligible to participate in the trial.|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.|||scores on a scale||Standard Deviation|Mean
2680680|NCT01399125|Secondary|Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score|NPI including Caregiver Distress Scale (NPI-D) assesses a wide range of behavior problems encountered in dementia patients to provide a means of distinguishing frequency and severity of changes in behavioral problems & facilitates rapid behavioral assessment using screening questions.10 behavioral problems & 2 neurovegetative domains were evaluated through an interview of the caregiver by a mental health professional. The scale includes both frequency & severity ratings of ea. domain as well as a composite domain score(frequency x severity). Frequency: 1(occasionally) - 4(very frequently)&severity:1(mild) - 3(marked).The sum of the composite scores of the 12 domains yields the NPI total score. The NPI-D: 0(not severe & not at all distressing) - 5 (very severe or extremely distressing) for each of the 12 domains. NPI-12 total score: from 0-144, the NPI-10 total score: from 0-120, & NPI-D score: from 0-60, all with higher scores indicating more severe behavioral disturbance.|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.|||scores on a scale||Standard Deviation|Mean
2680681|NCT01399125|Secondary|Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Total Score|"Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) is a caregiver-based Activities of Daily Living (ADL) scale composed of 23 items developed for use in dementia clinical studies. It was designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, as well as making judgments and decisions. Responses for each item were obtained from the caregiver through an interview. For each basic ADL, there was a forced choice of best response or a yes or no question with additional sub questions. Higher numbered scores and answers of yes reflected a more self-sufficient individual. Therefore, the higher total score, the higher functioning the patient was. The total score was the sum of all items and sub questions. The range for the total ADCS-ADL score was 0 to 78."|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.|||scores on a scale||Standard Deviation|Mean
2680682|NCT01399125|Secondary|Change From Baseline in Global Functioning, Assessed by the Alzheimer's Disease Assessment Scale Clinical Impression of Change (ADCS-CGIC)|Alzheimer's disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) scale provides a single global rating of change from baseline. It was recommended that the baseline interview be conducted by two raters, one designated as the primary rater, the other as a backup. Both raters were independent trained clinicians, experienced in the assessment of patients with dementia. Neither rater was involved in any other way with the patients' treatment or evaluation throughout the study. At baseline, both raters had access to all of the patient's available records and evaluations. Subsequently, for all ratings of change from baseline, the rater relied solely on information obtained during the baseline interview of the patient and caregiver, including written notes and, if available, the baseline interview audio- or videotape. The rater had no access to any other safety or efficacy data, including all previous post-baseline ADCS-CGIC ratings by either rater.|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.|||participants|||Number
2680683|NCT01399125|Primary|Change From Baseline on Cognition, Assessed by the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog)|The Alzheimer's Disease Assessment Scale (ADAS) is a performance-based test that measures specific cognitive and behavioral dysfunctions in patients with Alzheimer's Disease. The cognitive subscale of the ADAS (ADAS-Cog) comprises 11 items that are summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. It was assessed by a mental health professional (e.g., M.D., Ph.D., Pharm.D., R.N., or other equivalent qualifications) with a minimum of 2 years research experience meeting certification requirements.|Change at 24 weeks|Per Protocol (PP): patients who received at least one dose of study drug, had a baseline assessment and at least one post-baseline assessment on treatment (after Day 140 and not more than 2 days after the last known date of study drug) of the primary efficacy variable and have no major protocol deviations.|||Scores on a scale||Standard Deviation|Mean
2680688|NCT01399099|Primary|Visual Analogue Scale (VAS)|"Visual Analogue Scale Scar Score (VAS Scar Score) was defined and validated by Duncan et al 2006[1]. This scale consists of a 10cm line representing scar quality, with 0 representing normal skin and 10 indicating a poor scar. The assessor places a mark along the line to represent the appearance of the scar. This mark is translated into a score by measuring its position on the 10cm line to one decimal place. The independent panel used this to scale the primary outcome.~[1] Duncan J, Bond J, Mason T, Ludlow A, Cridland P, O'Kane S and Ferguson M. Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality? Plast. Reconstr. Surg. 118: 909, 2006."|12 months|Per protocol, all eligible patients who did not exit the study prematurely.|||Units on a scale||Standard Error|Mean
2680689|NCT01399047|Secondary|Unified Batten Disease Rating Scale Capability Subscale Change|"The Unified Batten Disease Rating Scale (UBDRS) is a disease-specific clinical assessment. Capability severity was measured by the capability subscale of the UBDRS with a range of 0-14 with higher scores indicating better outcome.~The overall treatment effect was determined - mean difference in capability subscale change (Mycophenolate minus placebo periods) in outcome, adjusted for baseline value and period effects."|Baseline to 8 weeks|All subjects who completed 8 weeks of the respective treatment arm assignment.|||units on a scale||95% Confidence Interval|Mean
2680690|NCT01399047|Secondary|Unified Batten Disease Rating Scale Behavior Subscale Change|"The Unified Batten Disease Rating Scale (UBDRS) is a disease-specific clinical assessment. Mood and behavior severity was measured by the behavior subscale of the UBDRS with a range of 0-55 with zero indicating better outcome.~The overall treatment effect was determined - mean difference in behavior subscale change (Mycophenolate minus placebo periods) in outcome, adjusted for baseline value and period effects."|Baseline to 8 weeks|All subjects who completed 8 weeks of the respective treatment arm assignment.|||units on a scale||95% Confidence Interval|Mean
2680691|NCT01399047|Secondary|Unified Batten Disease Rating Scale Seizure Subscale Change|"The Unified Batten Disease Rating Scale (UBDRS) is a disease-specific clinical assessment. Seizure severity was measured by the seizure subscale of the UBDRS with a range of 0-54 with zero indicating better outcome.~The overall treatment effect was determined - mean difference in seizure subscale change (Mycophenolate minus placebo periods) in outcome, adjusted for baseline value and period effects."|Baseline to 8 weeks|All subjects who completed 8 weeks of the respective treatment arm assignment.|||units on a scale||95% Confidence Interval|Mean
2680692|NCT01399047|Secondary|Unified Batten Disease Rating Scale Physical Subscale Change|"The Unified Batten Disease Rating Scale (UBDRS) is a disease-specific clinical assessment. Motor impairment was measured by the physical subscale of the UBDRS with a range of 0-112 with zero indicating better outcome.~The overall treatment effect was determined - mean difference in physical subscale change (Mycophenolate minus placebo periods) in outcome, adjusted for baseline value and period effects."|Baseline to 8 weeks|All subjects who completed 8 weeks of the respective treatment arm assignment.|||units on a scale||95% Confidence Interval|Mean
2680693|NCT01399047|Primary|Tolerability - Number of Participants Who Completed Each Arm on Assigned Study Drug Dose|The primary outcome measure is tolerability, defined as the completion of 8 weeks on the assigned dosage of study drug.|Baseline to 8 weeks|All subjects.|||Participants|||Count of Participants
2680694|NCT01399008|Primary|Serum Uric Acid|Percent change from baseline in serum uric acid in Per Protocol population|Percent change from baseline in serum uric acid at Week 4|Per Protocol population (all randomized patients who received at least 1 dose of blinded study drug, had at least 1 post-treatment evaluation, had not violated any major entry criterion likely to confound an efficacy analysis and had not deviated significantly from the protocol between enrollment and study completion).|||percent change||Standard Deviation|Mean
2680695|NCT01398982|Secondary|Time to Ambulation|Time to ambulation (# of days)|In-patient hospital stay, average 4-5 days|||||||
2680696|NCT01398982|Secondary|Health Related Quality of Life|Short-form health-related quality of life 36 Scores|Hospital discharge, average 4-5 days, 6 months and 1 year following discharge|||||||
2680697|NCT01398982|Secondary|Anxiety and Depression|Hospital Anxiety and Depression Scale Score|Hospital discharge, average 4-5 days, 6 months and 1 year following discharge|||||||
2680698|NCT01398982|Secondary|Pain Frequency and Intensity|Short-form McGill Pain Questionnaire Score|Hospital discharge, average 4-5 days, 6 months and 1 year following discharge|||||||
2680699|NCT01398982|Secondary|Sedation Level|Sedation score in-patient|In Hospital postoperative measures, average 4-5 days|||||||
2680700|NCT01398982|Secondary|Postoperative Nausea and Vomiting|Postoperative nausea and vomiting (score of 0-3)|In Hospital postoperative measures, average 4-5 days|||||||
2680701|NCT01398982|Secondary|Duration of Hospital Stay|Duration of hospital stay (# of days)|In-patient hospital stay, average of 4-5 days|||||||
2680702|NCT01398982|Secondary|Quality of Recovery|Quality of Recovery (QOR) score (0-18)|In-patient hospital stay, first post operative 48 hours|||||||
2680703|NCT01398982|Secondary|Anti-nausea Consumption|Total in-hospital cumulative anti-nausea consumption|In-patient hospital stay, average 4-5 days|||||||
2680704|NCT01398982|Secondary|First Bowel Movement|Time to first bowel movement (# of days)|In-patient hospital stay, average 4-5 days|||||||
2680705|NCT01398982|Secondary|Pain Disability|Pain Disability Index Scores|Hospital discharge, average 4-5 days, 6 months and 1 year following discharge|||||||
2680706|NCT01398982|Secondary|Daily Pain Intensity Scores at Rest and With Movement|Daily pain intensity scores at rest and with movement using a visual pain analogue scale (0-10)|In Hospital postoperative measures, average 4-5 days|||||||
2680707|NCT01398982|Secondary|Total In-hospital Cumulative Opioid Consumption|Total in-hospital cumulative opioid consumption levels|In-patient hospital stay average of 4 - 5 days|||||||
2680708|NCT01398982|Primary|Mean Total Opioid Consumption|The primary objective of this study is to compare the mean total opioid consumption in the first postoperative 48 hours between the control and study groups in intravenous morphine equivalent units. By directly blocking the neural afferents, the mean opioid consumption will be significantly lower in the group receiving intermittent local anaesthetic boluses compared to the placebo group through a TAP catheter.|first postoperative 48 hours||||mg||Standard Deviation|Mean
2681525|NCT01391858|Primary|Oral Opioids Consumption|Oral opioids consumption after mastectomy until hospital discharge.|Participants were followed for the consumption of oral opioid for the duration of hospital stay, an average of 3 days after mastectomy||||milligram (mg)||Inter-Quartile Range|Median
2680710|NCT01398956|Secondary|The Percentage Change in Generalized Tonic-Clonic (GTC) Seizure Frequency Per Week Over the Evaluation Period From Either of the Combined Baseline Periods of the Previous Studies (N01159 or N01363).|"Percentage change in generalized tonic-clonic (GTC) seizure frequency per week from Baseline of previous studies B over the Treatment Period A is calculated using the equation:~Percentage change from Baseline = ((A-B)/B)*100. Percentage change from baseline is not defined for subjects whose baseline information is missing / unknown or equal to zero, or whose seizure frequency per week is missing/unknown. A negative value in change in generalized tonic-clonic (GTC) seizure frequency indicates a reduction of generalized tonic-clonic (GTC) seizure frequency over the Treatment Period."|During the Treatment Period (up to 4.8 years)|The Full Analysis Set (FAS) consisted of all subjects with evaluable baseline and post-baseline values of generalized tonic-clonic (GTC) seizure frequency as the efficacy analysis, excluding those patients who seriously violated Good Clinical Practice (GCP).|||percent change||95% Confidence Interval|Median
2680711|NCT01398956|Primary|Incidence of Treatment Emergent Adverse Events During the Entire Study Period||Through study completion, an average of 3 years|The Safety Set (SS) consisted of all subjects who took at least one dose of study medication in this study.|||Treatment Emergent Adverse Events|||Number
2680712|NCT01398943|Secondary|Pulse Wave Velocity|A measure of vascular stiffness at baseline and several hours after each experimental intervention.|Post PWV was taken approximately 90 min after baseline|Patients diagnosed with COPD compared to healthy age-matched controls.|||m/sec||Standard Deviation|Mean
2680713|NCT01398943|Primary|Flow-Mediated Dilation (FMD)|Brachial artery FMD induced by reactive hyperemia will be used to assess vascular endothelial function at baseline and several hours after each experimental intervention.|Post FMD was taken approximately 110 min after baseline|Participants included patients diagnosed with COPD and healthy age-matched controls.|||percentage of change in FMD||Standard Deviation|Mean
2680714|NCT01398852|Primary|Changes in Corneal Curvature||24 MO|The CXL-003 study was terminated and data analysis was not done. The sponsor, Topcon Medical Systems, decided to terminate the study for administrative reasons only, and not as a result of any safety issues or concerns relating to the study.||||||
2680715|NCT01398839|Primary|Changes in Corneal Curvature||6 Months|The CXL-002 study was terminated and data analysis was not done. The sponsor, Topcon Medical Systems, decided to terminate the study for administrative reasons only, and not as a result of any safety issues or concerns relating to the study.||||||
2680716|NCT01398787|Primary|Percent Positive Purchase Intent (Definitely Would Buy, Probably Would Buy)|"The participant compared Pair 1 study lenses and indicated purchase intent by answering the following question, Assuming these lenses were at a price you would expect to pay, how likely would you be to purchase these lenses? using a 5-point Likert scale (definitely would buy, probably would buy, might or might not buy, probably would not buy, definitely would not buy). The combined percentage of the top two responses (definitely would buy, probably would buy) is reported. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1)."|Day 1, 2-10 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.|||Percentage of participants|||Number
2680717|NCT01398787|Primary|Percent Positive Responses: Cosmetic Appearance (Strongly Agree, Agree)|The participant compared the cosmetic appearance of Pair 1 study lenses on eye and answered 9 appearance-related questions using a 4-point Likert scale (strongly agree, agree, disagree, strongly disagree). The combined percentage of the top two responses (strongly agree, agree) is reported for each question. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2-10 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.|||Percentage of participants|||Number
2680718|NCT01398787|Primary|Subjective Rating of Initial Comfort|The participant compared the initial comfort (way it feels) of Pair 1 study lenses and rated initial comfort using a 10-point scale (1=poor, 10=excellent). Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.|||Units on a scale||Standard Deviation|Mean
2680719|NCT01398787|Primary|Appearance Preference|The participant compared the appearance (way it looks) of Pair 1 study lenses on eye and indicated preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Appearance preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2-10 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.|||Percentage of participants|||Number
2680720|NCT01398787|Primary|Initial Comfort Preference|The participant compared the initial comfort (way it feels) of Pair 1 study lenses and indicated preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Initial comfort preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.|||Percentage of participants|||Number
2680721|NCT01398787|Primary|Overall Preference|The participant compared Pair 1 study lenses on eye and indicated overall preference using a 4-point Likert scale (prefer lens in the left eye, prefer lens in the right eye, no preference, or both eyes are equal). Overall preference is reported as the percentage of participants who preferred the study lens. Each lens was assessed separately. This outcome measure was pre-specified for Analysis Population 1 (AP1).|Day 1, 2-10 minutes after lens insertion|The analysis population includes all enrolled and exposed participants in AP1, minus any discontinuations, missing responses, or protocol violations as determined by masked review.|||Percentage of participants|||Number
2684232|NCT01369732|Primary|Incidence of Acute Kidney Injury Based on RIFLE Criteria|Serum creatinine, GFR, urine output will be measured at 6:00 AM everyday up to 7 days after surgery.|upto 7 days after surgery|||||||
2680722|NCT01398514|Primary|Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Acquisition Trials 1 to 5|"Three-way interaction between group (active vs. placebo), CS (+ vs. -), and trials (1 - 5).~CS+ refers to the conditioned stimulus associated with the unconditioned stimulus (electric shock). Higher numbers reflect higher skin conductance response to the CS+ (conditioned stimulus).~CS- refers to the stimulus not associated with the unconditioned stimulus. Higher numbers reflect higher skin conductance response to a CS-.~Square-root transformed skin conductance conditioned response are reported for trials 1 to 5 of the Acquisition Phase."|Baseline on Day 1 of Fear Conditioning Paradigm (14 to 17 days post medication initiation)||||micro-Siemens (square rooted)||Standard Error|Mean
2680723|NCT01398514|Primary|Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Early Extinction Trials 1 to 4|"Three-way interaction between group (active vs. placebo), CS (+ vs. -), and trials (1 - 4).~CS+ refers to the conditioned stimulus associated with the unconditioned stimulus (electric shock). Higher numbers reflect higher skin conductance response to the CS+ (conditioned stimulus).~CS- refers to the stimulus not associated with the unconditioned stimulus. Higher numbers reflect higher skin conductance response to a CS-.~Square-root transformed skin conductance conditioned response are reported for trials 1 to 4 of the Early Extinction Phase."|Day 2 of Fear Conditioning Paradigm (15 to 18 days post medication initiation)||||micro-Siemens (square rooted)||Standard Error|Mean
2680724|NCT01398475|Secondary|Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax)||Predose up to 48 hours postdose for each of the 4 treatment periods|Randomized participants who received at least 1 dose of study drug.|||hours (h)||Full Range|Median
2680725|NCT01398475|Secondary|Pharmacokinetics: Maximum Plasma Concentration (Cmax)||Predose up to 48 hours postdose for each of the 4 treatment periods|Randomized participants who received at least 1 dose of study drug.|||nanomoles per liter (nmol/L)||Geometric Coefficient of Variation|Geometric Mean
2680726|NCT01398475|Primary|Pharmacokinetics: Plasma Concentration-Time Curve (AUC)|The area under the concentration-time curve from time 0 to infinity [AUC(0-inf)] is reported for participants who received either LY3009104 tablets or capsules in a fasted or fed state.|Predose up to 48 hours postdose for each of the 4 treatment periods|Randomized participants who received at least 1 dose of study drug.|||nanomoles*hours per liter (nmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2680727|NCT01398410|Secondary|Cumulative Recurrent Rate of Gastric or Duodenal Ulcers|Mucosal injuries with a white coat measuring greater than or equal to 3 mm in diameter was diagnosed as ulcers. When ulcer was confirmed by endoscopic examination during the trial, it was regarded as recurrence of ulcer and the trial was discontinued for the participant involved. The presence or absence of ulcer recurrence was determined by the endoscopy central review panel that were blinded to the investigators' assessments. Cumulative recurrent rate was estimated by the Kaplan-Meier method. The data is presented as percentage of participants with cumulative recurrent rate of gastric or duodenal ulcers.|Baseline, Week 12, Week 24, Week 52, and Week 76 (including data from the Double-Blind Phase)|The analysis was performed using Full Analysis Set, defined as all participants who received at least one dose of rabeprazole, with at least one post-initiation endoscopic assessment results, and showed no ulcers on baseline endoscopy; excluding participants from the newly-initiated rabeprazole groups of study E3810-J081-309.|||Percentage of participants||95% Confidence Interval|Number
2680728|NCT01398410|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs)|An AE was defined as any untoward medical occurrence in a participant administered with the study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study drug up to 30 days after the final dose of study drug) were assessed. The data is presented as percentage of participants with treatment emergent AEs.|For each participant, from administration of first dose of study drug (rabeprazole) up to 30 days from administration of last dose of study drug (rabeprazole) or up to 76 weeks (including data from the Double-Blind Phase)|The analysis was performed using Safety Analysis Set, defined as all participants who received at least one dose of rabeprazole.|||Percentage of participants|||Number
2680729|NCT01398358|Secondary|Change in Teacher-reported Self-regulation as Measured by the General Adaptation T-score From the Social Competence and Behavior Evaluation Scale|To assess self-regulation, teachers completed a modified 60-item version of the Social Competence and Behavior Evaluation (SCBE) scale.The SCBE assesses emotional and behavioral regulation difficulties typically seen in the preschool setting. It includes both positive (competence) and negative (emotional or behavioral problems) items, including internalizing (ie, anxious, sad) and externalizing (ie, oppositional) behaviors, both of which are indicators of poor behavioral self-regulation. The General Adaptation T-score assesses child overall emotional and behavioral self-regulation in the classroom setting. It is calculated by taking the mean of all 60 items for the SCBE questionnaire (with reverse scoring for questions capturing problem behavior) and then determining the corresponding t-score based on published tables. Higher scores indicate better self-regulation. The range for General Adaptation T-score is 30-70.|9 months||||change in t-score from pre to post||Standard Error|Mean
2680730|NCT01398358|Primary|Change in Body Mass Index Z-score|Child BMI z-score was calculated from measure height and weight at enrollment and at the end of the study period|9 months|Seven of the 697 were excluded from analysis because they were missing both pre- and post- intervention BMI z-score. It was possible for a child to be included in the final analysis population even if they had not completed the follow-up portion of the study because the mixed model statistical method used could include their pre-intervention data.|||Z-Score||Standard Error|Mean
2680731|NCT01398280|Primary|Kallikrein 5 (KLK5) Protease Activity|Serine protease activity of KLK5 in adult skin from patients with rosacea is measured after treatment with vehicle or aminocaproic acid cream. Protease activity of facial skin surface is monitored using a synthetic fluorogenic trypsin-like proteinase substrate. Protease activity is monitored as an increase of fluorescence (RFU/uL) with SpectraMax GEMINI EM.|Up to 12 weeks||||RFU/uL||Standard Deviation|Mean
2680732|NCT01398176|Primary|Physiological Modifications to Gamma Delta T Cell Function|Proliferation of γδ-T cells when cultured ex vivo in autologous serum. Values are expressed as a percent of CD3 cells, which means a percent of the total T cell population. Only T cells express CD3.|4 weeks|Intent to treat|||percent of T lymphocytes||Standard Error|Mean
2680733|NCT01398059|Secondary|Change in Glucose Net Incremental Area-Under-The-Curve (iAUC)|Blood draws will occur throughout the day, and the resulting values will be used to calculate AUC.|Baseline, 1.5, 3, 4.5, 6, and 7.5 hours||||mmol/L/min||Standard Deviation|Mean
2680734|NCT01398059|Secondary|Change in LDL-Cholesterol (LDL-C) Net Incremental Area-Under-The-Curve (iAUC)|Blood draws will occur throughout the day, and the resulting values will be used to calculate AUC.|Baseline, 1.5, 3, 4.5, 6, and 7.5 hours||||mmol/L/min||Standard Deviation|Mean
2680735|NCT01398059|Secondary|Change in HDL-Cholesterol (HDL-C) Net Incremental Area-Under-The-Curve (iAUC)|Blood draws will occur throughout the day, and the resulting values will be used to calculate AUC.|Baseline, 1.5, 3, 4.5, 6, and 7.5 hours||||mmol/L/min||Standard Deviation|Mean
2680736|NCT01398059|Secondary|Change in Triglyceride Net Incremental Area-Under-The-Curve (iAUC)|Blood draws will be taken several times throughout the day, and the resulting values will be used to calculate AUC.|Baseline, 1.5, 3, 4.5, 6, and 7.5 hours||||mmol/L/min||Standard Deviation|Mean
2680737|NCT01398059|Primary|Change in Insulin Net Incremental Area-Under-The-Curve (iAUC)|Insulin levels will be assessed multiple times throughout the day, and the resulting values will be used to calculate AUC.|Baseline, 1.5, 3, 4.5, 6, and 7.5 hours||||pmol/L/min||Standard Deviation|Mean
2680738|NCT01397890|Secondary|COPD Exacerbations|Severe exacerbations requiring systemic steroids (oral ≥3 days or parenteral) or hospitalisation or emergency room treatment due to worsening of COPD symptoms|Whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||exacerbations/participant/12 weeks||95% Confidence Interval|Least Squares Mean
2680739|NCT01397890|Secondary|Change in COPD Symptoms - Sputum|Change in Sputum symptom score (from 0:none to 4:severe) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||score on a scale||95% Confidence Interval|Least Squares Mean
2680740|NCT01397890|Secondary|Change in COPD Symptoms - Cough|Change in Cough symptom score (from 0:none to 4:severe) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||score on a scale||95% Confidence Interval|Least Squares Mean
2680741|NCT01397890|Secondary|Change in COPD Symptoms - Breathing|Change in breathing symptom score (from 0:none to 4:severe) from run-in period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||score on a scale||95% Confidence Interval|Least Squares Mean
2680742|NCT01397890|Secondary|Use of Reliever Medication During Night in the Whole Treatment Period|Change in the number of inhalations of reliever medication during night from run-in period to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||times/day||95% Confidence Interval|Least Squares Mean
2680743|NCT01397890|Secondary|Use of Reliever Medication During Night in the First Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in period to the first week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during night in the first week on treatment|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||times/day||95% Confidence Interval|Least Squares Mean
2680744|NCT01397890|Secondary|Use of Reliever Medication During Night in the Last Week on Treatment|Change in the number of inhalations of reliever medication during night from run-in period to the last week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||times/day||95% Confidence Interval|Least Squares Mean
2680745|NCT01397890|Secondary|Use of Reliever Medication During Day in the Whole Treatment Period|Change in the number of inhalations of reliever medication during day from run-in period to the whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||times/day||95% Confidence Interval|Least Squares Mean
2680746|NCT01397890|Secondary|Use of Reliever Medication During Day in the First Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in period to the first week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the first week on treatment|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||times/day||95% Confidence Interval|Least Squares Mean
2680747|NCT01397890|Secondary|Use of Reliever Medication During Day in the Last Week on Treatment|Change in the number of inhalations of reliever medication during day from run-in period to the last week on treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured during day in the last week on treatment, up to 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||times/day||95% Confidence Interval|Least Squares Mean
2680748|NCT01397890|Secondary|Post-dose PEF in Whole Treatment Period|Change in post-dose morning PEF at 5 minutes from run-period to whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||L/min||95% Confidence Interval|Least Squares Mean
2682731|NCT01381679|Secondary|Change From Baseline in Triglycerides (TG) at Month 3||Baseline and Month 3|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TG.|||mg/dL||95% Confidence Interval|Mean
2680749|NCT01397890|Secondary|Post-dose PEF in First Week of Treatment|Change in post-dose morning PEF at 5 minutes from run-in period to first week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the first week of treatment|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||L/min||95% Confidence Interval|Least Squares Mean
2680750|NCT01397890|Secondary|Post-dose PEF in Last Week of Treatment|Change in post-dose morning PEF at 5 minutes from run-period to last week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured at 5 minutes after inhalation of study drug in the last week of treatment, up to 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||L/min||95% Confidence Interval|Least Squares Mean
2680751|NCT01397890|Secondary|Pre-dose PEF in Whole Treatment Period|Change in pre-dose morning PEF from run-in period to whole treatment period|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in whole treatment period of 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||L/min||95% Confidence Interval|Least Squares Mean
2680752|NCT01397890|Secondary|Pre-dose PEF in First Week of Treatment|Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to first week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the first week of treatment|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||L/min||95% Confidence Interval|Least Squares Mean
2680753|NCT01397890|Secondary|Pre-dose PEF in Last Week of Treatment|Change in pre-dose morning PEF (Peak Expiratory Flow) from run-in period to last week of treatment|Mean of daily measurements in run-in period (the last 10 days before randomization) and mean of daily measurements measured before inhalation of study drug in the last week of treatment, up to 12 weeks|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||L/min||95% Confidence Interval|Least Squares Mean
2680754|NCT01397890|Secondary|Post-dose IC at 60 Minutes|Ratio of post-dose IC at 60 minutes to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||Ratio||95% Confidence Interval|Geometric Mean
2680755|NCT01397890|Secondary|Pre-dose IC|Ratio of pre-dose IC (Inspiratory Capacity) in treatment period to baseline value|Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||Ratio||95% Confidence Interval|Geometric Mean
2680756|NCT01397890|Secondary|Post-dose FVC at 60 Minutes|Ratio of post-dose FVC at 60 minutes to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||Ratio||95% Confidence Interval|Geometric Mean
2680757|NCT01397890|Secondary|Post-dose FVC at 5 Minutes|Ratio of post-dose FVC at 5 minutes to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 5 minutes after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||Ratio||95% Confidence Interval|Geometric Mean
2680758|NCT01397890|Secondary|Pre-dose FVC|Ratio of pre-dose FVC (Forced Vital Capacity) in treatment period to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||Ratio||95% Confidence Interval|Geometric Mean
2680759|NCT01397890|Secondary|Post-dose FEV1 at 60 Minutes|Ratio of post-dose FEV1 at 60 minutes to baseline value|Baseline (measured before inhalation of study drug at week 0) and mean in treatment period (measured at 1 hour after inhalation of study drug at weeks 0, 1, 6, 12)|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||Ratio||95% Confidence Interval|Geometric Mean
2680760|NCT01397890|Secondary|Post-dose FEV1 at 5 Minutes|Ratio of post-dose FEV1 at 5 minutes to baseline value|Baseline (-2 weeks) and mean in treatment period (1, 6, 12 weeks) measured at 5 minutes after inhalation of study drug|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||Ratio||95% Confidence Interval|Geometric Mean
2680761|NCT01397890|Primary|Pre-dose FEV1|Ratio of pre-dose FEV1 (Forced Expiratory Volume in 1 second) in treatment period to baseline value|Baseline (week 0) and mean in treatment period (weeks 1, 6, 12) measured before inhalation of study drug|FAS (287 + 290); less number of patients analyzed was caused by missing values.|||Ratio||95% Confidence Interval|Geometric Mean
2680762|NCT01397851|Secondary|Self-reported Malaria Prevalence|Over two weeks before interview, collected through validation survey. Odds ratio calculated in accordance with NIH guidance http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2938757/|2010-2011 season (up to 1 year)|Subset of study population selected for validation survey|||odds ratio|||Number
2680763|NCT01397851|Secondary|Increase in Maize Productivity|Increase in self-reported maize productivity (yield on maize plots divided by size of maize plots), collected through validation survey; calculated as maize productivity 2010-11 minus maize productivity 2009-10, measured in bags (ordinarily 50kg bags; however, kg measure not specified)|2009-2010 and 2010-2011 seasons (up to 2 years)|Subset of study population selected for validation survey|||bags (not further specified)||Standard Error|Mean
2680764|NCT01397851|Secondary|Contract Defaults|Defaults on input loans, as defined in the routine data collection system of the participating cotton outgrowing agribusiness. Odds ratios calculated in accordance with NIH guidance: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2938757/|2010-2011 season (up to 1 year)||||odds ratio|||Number
2680765|NCT01397851|Primary|Cotton Yields|Farmer's cotton yields (kg delivered per household), as defined in the routine data collection system of the participating cotton outgrowing agribusiness|2010-2011 season (up to 1 year)||||kg||Standard Deviation|Mean
2681059|NCT01396148|Primary|Maximum Observed Plasma Concentration (Cmax) of Sunitinib and Its Metabolite|SU012662 is the metabolite of Sunitinib.|Cycle 1 Day 1: pre-dose, 2, 4, 6, and 8 hours post-dose|The PK population included all treated participants with at least one PK observation.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2680766|NCT01397825|Secondary|T1/2: Terminal Disposition Phase Half-life for Vincristine||Cycles 1 and 2 on Day prior to injection of vincristine and multiple time-points (up to 72 hours) post-dose|Vincristine PK-evaluable population was defined as participants with sufficient dosing and concentration-time data to permit non-compartmental PK analysis. Safety Lead-in arm did not receive vincristine. Number analyzed is the number of participants with data available at the time-point. No data was collected for the alisertib 50 mg arm in Cycle 2.|||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
2680767|NCT01397825|Secondary|AUC∞: Area Under the Concentration-time Curve From Time 0 to Infinity for Vincristine||Cycles 1 and 2 on Day 1 prior to injection of vincristine and multiple time-points (up to 72 hours) post-dose|Vincristine PK-evaluable population was defined as participants with sufficient dosing and concentration-time data to permit non-compartmental PK analysis. Safety Lead-in arm did not receive vincristine. Number analyzed is the number of participants with data available at the time-point. No data was collected for the alisertib 50 mg arm in Cycle 2.|||ng/mL*hr||Standard Deviation|Mean
2680768|NCT01397825|Secondary|AUCt: Area Under the Concentration-time Time Curve Over the Dosing Interval From Time 0 to Time t for Vincristine||Cycles 1 and 2 on Day 1 prior to injection of vincristine and multiple time-points (up to 72 hours) post-dose|Vincristine PK-evaluable population was defined as all participants with sufficient dosing and vincristine concentration-time data to permit non-compartmental PK analysis. Safety Lead-in arm did not receive vincristine Number analyzed is the number of participants with data available at the given time-point.|||ng/mL*hr||Standard Deviation|Mean
2680769|NCT01397825|Secondary|Cmax: Maximum Plasma Concentration for Vincristine||Cycles 1 and 2 on Day 1 prior to injection of vincristine and multiple time-points (up to 72 hours) post-dose|Vincristine PK-evaluable population was defined as all participants with sufficient dosing and vincristine concentration-time data to permit non-compartmental PK analysis. Safety Lead-in arm did not receive vincristine. Number analyzed is the number of participants with data available at the given time-point.|||ng/mL||Standard Deviation|Mean
2680770|NCT01397825|Secondary|AUCt: Area Under the Concentration Time Curve Over the Dosing Interval From Time 0 to Time t for Alisertib||Cycle 1 Days 1 and 7 prior to morning alisertib dose and multiple time-points (up to 12 hours) post-dose|Alisertib PK-Evaluable Population was defined as all participants with sufficient dosing and alisertib concentration-time data to permit non-compartmental PK analysis. Number analyzed is the number of participants with data available at the given time-point.|||nanomoles/liter*hour (nmol/L*hr)||Standard Deviation|Mean
2680771|NCT01397825|Secondary|Tmax: Time to First Occurrence of Cmax fo Alisertib||Cycle 1 Days 1 and 7 prior to morning alisertib dose and multiple time-points (up to 12 hours) post-dose|Alisertib PK-Evaluable Population was defined as all participants with sufficient dosing and alisertib concentration-time data to permit non-compartmental PK analysis. Number analyzed is the number of participants with data available at the given time-point.|||hours (hr)||Full Range|Median
2680772|NCT01397825|Secondary|Cmax: Maximum Plasma Concentration for Alisertib||Cycle 1 Days 1 and 7 prior to morning alisertib dose and multiple time-points (up to 12 hours) post-dose|Alisertib Pharmacokinetic (PK)-Evaluable Population was defined as all participants with sufficient dosing and alisertib concentration-time data to permit non-compartmental PK analysis. Number analyzed is the number of participants with data available at the given time-point.|||nanoMolar (nM)||Standard Deviation|Mean
2680773|NCT01397825|Secondary|Number of Participants With Clinically Significant Laboratory Tests Reported as Adverse Events [Phase 2]||From screening period to 30 days after last dose of study drug, approximately 2 years|Phase 2 portion of the study was cancelled by the sponsor.||||||
2680774|NCT01397825|Secondary|Number of Participants With Clinically Significant Changes in Multigated Acquisition (MUGA)/ Echocardiogram (ECHO) [Phase 2]||From screening period to 30 days after last dose of study drug, approximately 2 years|Phase 2 portion of the study was cancelled by the sponsor.||||||
2680775|NCT01397825|Secondary|Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs) [Phase 2]||From screening period to 30 days after last dose of study drug, approximately 2 years|Phase 2 portion of the study was cancelled by the sponsor.||||||
2680776|NCT01397825|Secondary|Number of Participants With Clinically Significant Vital Signs Findings [Phase 2]|Vital sign parameters: blood pressure, heart rate and temperature determined by the investigator to be clinically significant were reported as adverse events.|From screening period to 30 days after last dose of study drug, approximately 2 years|Phase 2 portion of the study was cancelled by the sponsor.||||||
2680777|NCT01397825|Secondary|Number of Participants With Treatment-Emergent Adverse Events [Phase 2]|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|From screening period to 30 days after last dose of study drug, approximately 2 years|Phase 2 portion of the study was cancelled by the sponsor.||||||
2680778|NCT01397825|Secondary|Progression Free Survival (PFS) [Phase 2]|PFS was defined as the time from the date of first study drug administration to the date of first documentation of PD or death.|Duration of study until disease progression, approximately 2 years|The Phase 2 portion of the study was cancelled by the sponsor.||||||
2680779|NCT01397825|Secondary|Duration of Response (DOR) [Phase 2]|DOR was defined as the time from the date of first documentation of a response to the date of first documentation of Progressive Disease (PD).|Duration of study until disease progression, approximately 2 years|Phase 2 portion of the study was cancelled by the sponsor.||||||
2680780|NCT01397825|Secondary|Complete Response Rate [Phase 2]|Complete response rate was defined as the percentage of participants with Complete Response (CR). CR was assessed by the investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease.|Duration of study until disease progression, approximately 2 years|Phase 2 portion of the study was cancelled by the sponsor.||||||
2680826|NCT01397422|Primary|Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8|The UDysRS is a dyskinesia rating scale from 0-104, and it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The last observation carried forward (LOCF) method was used for analysis. Participants were summarized according to the actual treatment received.|Baseline (Day 1) and Week 8|Participants in the MITT population with available data were analyzed.|||units on a scale||Standard Error|Least Squares Mean
2680781|NCT01397825|Secondary|Overall Response Rate as Assessed by the Investigator [Phase 1]|Overall Response Rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) as assessed by the investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.|First dose of alisertib through 30 days after the last dose of alisertib (Up to 5.2 Years)|Response-Evaluable Population was defined as all participants with measurable disease who received at least 1 dose of alisertib and had at least 1 post-baseline response assessment.|||percentage of participants||95% Confidence Interval|Number
2680782|NCT01397825|Primary|Overall Response Rate [Phase 2]|Overall Response Rate was defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) as assessed by the investigator using International Working Group (IWG) Criteria. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.|At the end of Cycle 2, at the end of every second treatment cycle until 6 months, then every 12 weeks thereafter, approximately 2 years|The Phase 2 portion of the study was cancelled by the sponsor.||||||
2680783|NCT01397825|Primary|Number of Participants With Treatment-Emergent Adverse Events [Phase 1]|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|First dose of alisertib through 30 days after the last dose of alisertib (Up to 5.2 Years)|Safety Population was defined as all participants who receive any amount of alisertib.|||participants|||Number
2680784|NCT01397825|Primary|Number of Participants With Clinically Significant Laboratory Tests Reported as Adverse Events [Phase 1]|Abnormal treatment-emergent Chemistry and Hematology Laboratory values determined by the investigator to be clinically significant were reported as adverse events.|First dose of alisertib through 30 days after the last dose of alisertib (Up to 5.2 Years)|Safety Population was defined as all participants who receive any amount of alisertib.|||participants|||Number
2680785|NCT01397825|Primary|Number of Participants With Clinically Significant Changes in Physical Examination Findings [Phase 1]|Abnormal Physical Examination findings determined by the investigator to be clinically significant were reported as Adverse Events.|First dose of alisertib through 30 days after the last dose of alisertib (Up to 5.2 Years)|Safety Population was defined as all participants who receive any amount of alisertib.|||participants|||Number
2680786|NCT01397825|Primary|Number of Participants With Clinically Significant Changes in Multigated Acquisition (MUGA)/ Echocardiogram (ECHO) [Phase 1]|Abnormal changes in MUGA and ECHO findings determined by the investigator to be clinically significant were reported as adverse events.|First dose of alisertib through 30 days after the last dose of alisertib (Up to 5.2 Years)|Safety Population was defined as all participants who receive any amount of alisertib.|||participants|||Number
2680787|NCT01397825|Primary|Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs) [Phase 1]|Abnormal ECGs findings determined by the investigator to be clinically significant were reported as adverse events.|First dose of alisertib through 30 days after the last dose of alisertib (Up to 5.2 Years)|Safety Population was defined as all participants who receive any amount of alisertib.|||participants|||Number
2680788|NCT01397825|Primary|Number of Participants With Clinically Significant Vital Signs Findings (Treatment Related and Unrelated) [Phase 1]|Vital sign parameters: blood pressure, heart rate and temperature determined by the investigator to be clinically significant were reported as adverse events.|First dose of alisertib through 30 days after the last dose of alisertib (Up to 5.2 Years)|Safety Population was defined as all participants who receive any amount of alisertib.|||participants|||Number
2680789|NCT01397786|Secondary|Mean Change From Baseline in PANSS Marder Factor Scores - Anxiety/Depression Score|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items (anxiety (G2), guilt feelings (G3), tension (G4) and depression (G6)) on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
2680790|NCT01397786|Secondary|Mean Change From Baseline in PANSS Marder Factor Scores - Hostility/ Excitement Score|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items (excitement (P4), hostility (P7), uncooperativeness (G8) and poor impulse control (G14)) on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
2680791|NCT01397786|Secondary|Mean Change From Baseline in PANSS Marder Factor Scores - Disorganized Thought Score|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items (conceptual disorganization (P2), difficulty in abstract thinking (N5), mannerisms and posturing (G5), disorientation (G10), poor attention (G11), disturbance of volition (G13) and preoccupation (G15)) on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome).|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
2686285|NCT01351506|Primary|In Hospital Mortality|28 days mortality if patient still have be admitted in hospital.|within 28 days after ICU admission to dead|Total 465 patients|||participants|||Number
2680792|NCT01397786|Secondary|Mean Change From Baseline in PANSS Marder Factor Scores - Negative Symptoms Score|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items (blunted affect (N1), emotional withdrawal (N2), poor rapport (N3), passive/apathetic social withdrawal (N4), lack of spontaneity and conversation flow (N6), motor retardation (G7) and active social avoidance (G16)) of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome).|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
2680793|NCT01397786|Secondary|Mean Change From Baseline in PANSS Marder Factor Scores - Positive Symptoms Score|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score was the sum of the 8 components (delusions (P1), hallucinatory behavior (P3), grandiosity (P5), suspiciousness/persecution (P6), stereotyped thinking (N7), somatic concern (G1), unusual thought content (G9) and lack of judgment and insight (G12)) of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome).|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
2680794|NCT01397786|Secondary|Mean Change From Baseline in Positive and Negative Syndrome Scale Excited Component Score|The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe).|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
2680795|NCT01397786|Secondary|Discontinuation Rate for Lack of Efficacy|Discontinuation rate for the participants who discontinued due to lack of efficacy were examined.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||percentage of participants|||Number
2680796|NCT01397786|Secondary|Response Rate|Response rate was defined as a reduction of ≥ 30% from Baseline in PANSS total score or CGI-I score of 1 (very much improved) or 2 (much improved) at the Last Visit.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||percentage of participants|||Number
2680797|NCT01397786|Secondary|Mean Clinical Global Impression - Improvement Score|The efficacy of study medication was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was due to the drug treatment. All responses were compared to the participant's condition at Screening/Baseline (i.e, Week 6 visit of Protocol NCT00905307). Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
2680798|NCT01397786|Secondary|Mean Change From Baseline in Personal and Social Performance Scale Total Score|The PSP was a validated clinician-rated scale that measured personal and social functioning in four domains: socially useful activities (e.g, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment that determined the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
2680799|NCT01397786|Secondary|Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale Score|"The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the investigator were to answer the following question: Considering your total clinical experience with this particular population, how mentally ill was the participant at that time? Response choices include: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
2680800|NCT01397786|Secondary|Mean Change From Baseline in PANSS Negative Subscale Score|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In negative subscale the severity was rated for the following 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
2680828|NCT01397409|Secondary|Stage 3: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline, Week 4|Per-protocol Population included all treated participants who received all scheduled treatments.|||microns||Standard Deviation|Mean
2680801|NCT01397786|Secondary|Mean Change From Baseline in PANSS Positive Subscale Score|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
2680802|NCT01397786|Secondary|Mean Change From Baseline in Positive and Negative Syndrome Scale Total Score|The PANSS consisted of 3 subscales with 30 symptom constructs (positive subscale (7): delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/perseckion, and hostility; negative subscale (7): blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and conversation flow, stereotyped thinking and general psychopathology subscale (16): somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Severity was rated on 7-point scale with scores 1 (absence) & 7 (extremely severe). The PANSS total score was sum of rating scores for 7 positive, 7 negative, and 16 general psychopathology subscale items of PANSS panel.|From Baseline up to 52 Weeks|The Efficacy Sample included participants in the Safety Sample who had at least 1 post-baseline efficacy evaluation for PANSS Total Score.|||Units on a scale||Standard Deviation|Mean
2680803|NCT01397786|Primary|Percentage of Participants With Adverse Events (AEs)|A treatment-emergent adverse event (TEAE) is defined as an AE that started after start of investigational medicinal product (IMP) treatment; or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption or reduction of IMP.|From Baseline up to 52 Weeks|Safety sample included those participants who had at least one post-baseline efficacy evaluation for Positive and Negative Syndrome Scale (PANSS) total score.|||percentage of participants|||Number
2680804|NCT01397747|Primary|Sensitivity and Specificity of the Exact CRC Screening Test With Comparison to Colonoscopy, Both With Respect to Cancer.|An optical colonoscopic procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The DNA test includes quantitative molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, and Beta-actin, plus a hemoglobin immunoassay. Results were generated with the use of a logistic-regression algorithm, with values of 183 or more considered to be positive. FIT values of more than 100 ng of hemoglobin per milliliter of buffer were considered to be positive. Tests were processed independently of colonoscopic findings. The test functions as a screening tool by generating a score, based on the detection of hemoglobin and multiple DNA methylation and mutational markers, together with an assessment of the total amount of human DNA in each sample. Sensitivity= 100*(multitarget DNA or FIT positive test/positive colonoscopy); Specificity= 100*(multitarget DNA or FIT negative test/negative colonoscopy).|90 Days||||percent||95% Confidence Interval|Number
2680805|NCT01397695|Primary|Measurement of Epistaxis in Patients With HHT as Measured by the HHT Foundation Epistaxis Severity Score, Hematocrit, Hemoglobin and Serum Ferritin Levels.|The Responsible Party for this record has passed away in 2013. There are no study team members still associated with this study at the institution. There have been no publications, and the study data cannot be located.|1-2 years|The Responsible Party for this record has passed away in 2013. There are no study team members still associated with this study at the institution. There have been no publications, and the study data cannot be located.||||||
2680806|NCT01397656|Secondary|Borg Rating of Perceived Exertion Scale|The Borg Rating of Perceived Exertion scale ranges from 6-20, where a score of 6 is associated with the least fatigue|Assessed immediately before and after 5 minutes of CPR||||units on a scale||Standard Deviation|Mean
2680807|NCT01397656|Secondary|Blood Pressure|Mean arterial pressure (mmHg)|Assessed immediately before and after 5 minutes of CPR||||mmHg||Standard Deviation|Mean
2680808|NCT01397656|Secondary|Heart Rate||Assessed immediately before and after 5 minutes of CPR||||beats per minute||Standard Deviation|Mean
2680809|NCT01397656|Primary|CPR Quality|Count of compressions at a depth over 2 inches|5 minutes||||Compressions||Standard Deviation|Mean
2680810|NCT01397617|Secondary|Implant Survival Rate From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months).|An implant was reported to be a surviving implant when it remained in the jaw and was functionally loaded even if not all the individual success criteria were fulfilled (i) an implant that causes no allergic, toxic or gross infectious reactions either locally or systemically, ii) offered anchorage to a functional prosthesis, iii) showed no signs of fracture or bending, iv) showed no signs of peri-implant radiolucency on an intraoral radiograph using a paralleling technique strictly perpendicular to the implant-bone interface, and v) showed no mobility when individually tested by either tapping or rocking with a hand instrument).|baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months|Intention to treat analysis.|||percentage of surviving implants|Participants||Number
2680811|NCT01397617|Primary|The Primary Endpoint Was the Change in Marginal Bone Levels (in mm) From the Time of Implant Insertion to Follow-up Visits (3,6,12,24,36 and 60 Months).|"Marginal bone remodeling is calculated for each side of the implant (mesial and distal) separately, as the difference between bone levels at two time points. The average of mesial and distal remodeling is then calculated for each implant site (paired for each side between two different points). Negative numbers indicate bone loss. Implant insertion was defined as a baseline.~Missing data was not imputed and not included in evaluation."|baseline, 3 months, 6 months, 12 months, 24 months, 36 months and 60 months|Intent to treat analysis (all participants who received at least one implant were analyzed). Missing data was not imputed and not included in evaluation.|||mm||Standard Deviation|Mean
2680827|NCT01397409|Secondary|Stage 3: Change From Baseline in BCVA in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 4|Per-protocol Population included all treated participants who received all scheduled treatments.|||letters||Standard Deviation|Mean
2680812|NCT01397591|Secondary|Number of Participants With Adverse Events (Toxicity)|Toxicities and adverse experiences will be assessed at each visit using the NCI Common Toxicity Criteria for Adverse Events v4.0 Interim analyses on toxicity will be implemented based on the toxicity endpoints of the first 6 patients, and will be conducted sequentially 4 weeks after the treatment of each patient, or when serious toxicity has been observed for the patient, whichever comes earlier. we assume a non-informative prior distribution (Beta (0.001, 0.001)) for toxicity rate, and compute the posterior distribution of toxicity rate sequentially.|Days 1, 8, and 15 of each course and 4-6 weeks after final treatment||||participants|||Number
2680813|NCT01397591|Secondary|Disease Free Survival|The period of time between complete remission and recurrence of disease.|Up to every 3 months for 2 years|Study closed by PI due to lack of accrual before this outcome measure could be analyzed.||||||
2680814|NCT01397591|Secondary|Progression Free Survival|This outcome measure is defined as the length of time after treatment during which the patient survives with no sign of the disease.|Up to every 3 months for 2 years|Study closed by PI due to lack of accrual before this outcome measure could be analyzed.||||||
2680815|NCT01397591|Secondary|Overall Survival|This outcome measure is defined as the time from initiation of treatment to death due to any cause.|Up to every 3 months for 2 years|Study closed by PI due to lack of accrual before this outcome measure could be analyzed.||||||
2680816|NCT01397591|Primary|Response Rate of Ofatumumab in Combination With Bortezomib in Patients With Relapsed CD20+ (Cluster of DIfferentiation Antigen 20) Diffuse Large B Cell Lymphoma, Follicular Lymphoma, or Mantle Cell Lymphoma|Based on International Working Group (IWG) criteria, recorded in four categories: Complete Response (CR), disappearance of all evidence of disease; Partial Response (PR), regression of measurable disease and no new sites of disease; Progressive Disease (PD), Any new lesion or increase by >= 50% of previously involved sites from nadir. Stable Disease (SD), failure to attain CR/PR or PD. A response is defined to be either CR/PR. A failure in response includes SD/PD.|Every 2 cycles during treatment and then every 3 months for 2 years||||participants|||Number
2680817|NCT01397552|Primary|To Determine if One Medication is Better at Relieving Pain Than the Other.|Subjects will be asked to return at 2 wks, 6 wks and 12 weeks the above time points to complete outcome measurements questionnaires and undergo a neurological examination, the 12 weeks outcome should show improvement s/p injection|12 wk post injection|enrollment was too low and half of the subjects did not complete study requirements, no data collected for analysis||||||
2680818|NCT01397461|Primary|Clinical Success|"Clinical response (clinical success or clinical failure) at end of therapy (Visit 3) in the intent to treat clinical (ITTC) population.~Clinical succes at Visit 3 was defined as: SIRS score 0 for exudates/pus, crusting, tissue warmth and pain and no more than 1 each for erythema/inflammation, tissue edema and itching such that no additional antimicrobial therapy in the baseline (Visit 1) affected area is necessary.~The SIRS is a severity index based on seven signs or symptoms:~Exudate/pus~Crusting~Erythema/inflammation~Tissue warmth~Tissue oedema~Itching~Pain~Each sign/symptom is rated on a scale from 0 to 6:~0 = absent~1 2 = mild 3 4 = moderate 5 6 = severe"|2 weeks||||percentage of participants|||Number
2680819|NCT01397448|Primary|Cumulative Recurrent Rates of Gastric or Duodenal Ulcers|Mucosal injuries with a white coat measuring 3 mm in diameter will be diagnosed as ulcers. When ulcer is confirmed by endoscopic examination during the trial, it will be regarded as recurrence of ulcer and the trial will be discontinued for the patient involved.|24 weeks|Defined as all randomized participants who received at least one dose of the study drug and showed no ulcers at baseline, and from whom the results of at least one endoscopic assessment was available.|||Events/100 participants/24 weeks||95% Confidence Interval|Number
2680820|NCT01397448|Secondary|Cumulative Incidence of Bleeding Ulcers||24 weeks|Defined as all randomized participants who received at least one dose of the study drug and showed no ulcers at baseline, and from whom the results of at least one endoscopic assessment was available.|||Events/100 participants/24 weeks||95% Confidence Interval|Number
2680821|NCT01397422|Secondary|Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8|The CGI-C consisted of a single question that assessed the investigator's global impression of the subject's change from Baseline in overall PD symptoms, including but not limited to LID. The CGI-C required that the investigator rate the extent to which the subject's PD had improved or worsened (from marked worsening to marked improvement).|Baseline (Day 1) and Week 8|MITT population|||Participants|||Count of Participants
2680822|NCT01397422|Secondary|Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8|The MDS-UPDRS Parts I, II, and III examined non-motor experiences of daily living, motor experiences of daily living, and motor examination, respectively. Each part had sub scales ranging from normal = 0 to severe = 4.|Baseline (Day 1) and Week 8|MITT population|||units on a scale||Standard Error|Least Squares Mean
2680823|NCT01397422|Secondary|Change in ON Time Without Troublesome Dyskinesia (ON Without Dyskinesia Plus ON With Non-troublesome Dyskinesia) From Baseline to Week 8; Based on a Standardized PD Home Diary|A PD home diary was used to score 5 different conditions in 30-minute time intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. The results were based on 2 consecutive 24-hour diaries taken prior to the day of randomization and prior to the Week 8 visit.|Baseline (Day 1) and Week 8|MITT population|||hours||Standard Error|Least Squares Mean
2680824|NCT01397422|Secondary|Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8|UDysRS Part III measures objective impairment (dyskinesia severity, anatomic distribution, and type, based on 4 observed activities); and Part IV measures objective disability based on Part III activities. The scores for the 2 Parts combined range from 0-44; a higher score represents more severe dyskinesia.|Baseline (Day 1) and Week 8|MITT Population|||units on a scale||Standard Error|Least Squares Mean
2680825|NCT01397422|Secondary|Change in the Fatigue Severity Score (FSS) From Baseline to Week 8|The FSS is a 9-item self-reported scale, rating subject experience of fatigue during the previous 7 days. The total score, on a scale from 1-7, is represented by the mean of all answered items. The higher the score, the greater the fatigue severity.|Baseline (Day 1) and Week 8|MITT population|||units on a scale||Standard Error|Least Squares Mean
2681896|NCT01388816|Primary|Percent Change in HDL-C From Baseline|Percent change from baseline in HDL-C after 28 days of treatment in patients with Type II hyperlipidemia|28 days|Intention to treat (ITT) analysis with last observation carried forward (LOCF) for missing data.|||percent change from baseline||95% Confidence Interval|Least Squares Mean
2680829|NCT01397409|Secondary|Stage 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 4|Per-protocol Population included all treated participants who received all scheduled treatments.|||letters||Standard Deviation|Mean
2680830|NCT01397409|Secondary|Stage 2: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline, Week 4|Per-protocol Population included all treated participants who received all scheduled treatments.|||microns||Standard Deviation|Mean
2680831|NCT01397409|Secondary|Stage 2: Time Between Second Treatment and Recurrence of Active Disease|Recurrence of active disease is defined as the time in days to escape to standard of care. Time is calculated as (date of Escaping to Standard of Care/Censoring minus the date of the Second Injection) +1.|32 Weeks|mITT Population|||days||Inter-Quartile Range|Median
2680832|NCT01397409|Primary|Stage 3: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye|BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.|Baseline, Week 16|Modified-Intent-to-Treat (mITT) Population|||letters||Standard Deviation|Mean
2680833|NCT01397409|Primary|Stage 2: Time Between Baseline Treatment and Recurrence of Active Disease|Recurrence of Active Disease was based on Best Corrected Visual Acuity (BCVA), Central Retinal Thickness (CRT) values as evaluated by the Central Reading Center (CRC) and the investigator assessments of haemorrhage.|Baseline, Week 16|Per-protocol Population included all treated participants who received all scheduled treatments.|||days||Inter-Quartile Range|Median
2680834|NCT01397409|Primary|Stage 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye|CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.|Baseline, Week 4|Safety population included all treated participants.|||microns||Standard Deviation|Mean
2680835|NCT01397409|Primary|Highest Tolerated Dose (HTD) of AGN-150998|Stage 1 evaluated the safety of a single intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.|24 Weeks|Safety population included all treated participants.|||mg|||Number
2680836|NCT01397253|Secondary|Patient PCP Visits, Emergency Room Visits and Rehospitalizations Within 30 Days Post-discharge.|Details regarding patient PCP follow-up office appointments, ER visits and rehospitalizations occuring within 30 days post-discharge will be collected from the EMR.|Within 30 post-discharge from hospital|||||||
2680837|NCT01397253|Primary|Medication Errors at Hospital Discharge|Medication name, dose, and frequency of administration for patient pre-admission medications will be recorded. Medications received during the hospitalization and discharge medications will be obtained by medical record review following hospital discharge. Pre-admission medications will be compared to discharge medications and differences will be considered discharge medication variances. Two trained pharmacists will independently review medication variances to determine clinical indications or medication errors.|Approximately 1-30 days|Hospitalized medical patients with ≥2 comorbidities and ≥5 chronic medications, at a single center|||Errors|Participants||Number
2680838|NCT01397084|Secondary|Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1).|"Maximum severity of heartburn during 7 days at baseline and at 8 weeks was obtained (None, Mild, Moderate, Severe). If the value at 8 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened."|Baseline and 8 weeks|Efficacy Population (104 participants)|||Participants|||Number
2680839|NCT01397084|Secondary|Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1).|"Maximum severity of heartburn during 7 days at baseline and at 4 weeks was obtained (None, Mild, Moderate, Severe). If the value at 4 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened."|Baseline and 4 weeks.|101 Participants out of efficacy population (104 participants) who had data related to heartburn at Week 4 were used.|||Participants|||Number
2680840|NCT01397084|Secondary|Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1).|The number of days with heartburn during the 7-day period prior to the 4 week visit (Visit 2) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 4 weeks was analysed.|Baseline and 4 weeks|101 Participants out of efficacy population (104 participants) who had data related to heartburn at Week 4 were used.|||Days with heartburn||Standard Deviation|Mean
2680841|NCT01397084|Primary|Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1).|The number of days with heartburn during the 7-day period prior to the 8 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 8 weeks was analysed.|Baseline and 8 weeks|Efficacy Population (104 participants)|||Days with heartburn||Standard Deviation|Mean
2680842|NCT01397071|Secondary|Change in Inflammation Marker Nuclear Factor of Kappa Light Polypeptide Gene Enhancer in B-cells Inhibitor Alpha (IkB-alpha)|Change from baseline inflammatory marker IkB-alpha in response to the consumption of 250 g beef patty with or without 68 g avocado added was assessed at 0 (baseline), 1, 2, 3, 4, 5, 6 hours post-ingestion. Baseline and 3 hours post-ingestion was reported.|0 (baseline) and 3 hours post-ingestion||||percentage of baseline||Standard Deviation|Mean
2680843|NCT01397071|Primary|Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI)|Change from baseline in reactive hyperemia index (RHI) in response to consumption of 250 g beef patty with or without 68 g avocado added at 2 hour post-ingestion. RHI is a measure of endothelial dysfunction using noninvasive peripheral arterial tonometry (PAT). It is a ratio of the post-to-pre occlusion PAT amplitude of the tested arm, divided by the post-to-pre occlusion ratio of the control arm. RHI less than 1.67 is considered sign of endothelial dysfunction and RHI equal to or greater than 1.67 is considered normal function. The possible range of scores is 1 to 3. Increasing score indicates the improvement of coronary endothelial function.|Baseline and 2 hours post-ingestion||||score on a scale||Standard Deviation|Mean
2680844|NCT01396551|Secondary|To Calculate the Potential Reduction in Volume and Dose of Normal Lung Irradiated When a Reduced Margin is Used for the Planning Target Volume|To calculate the potential reduction in volume and dose of normal lung irradiated when routine institutional planning target volume margins are reduced to a margin of 0.5 cm circumferentially made possible by realtime localization and tracking of the tumor. This calculation will be done for a subset of the patients.|1-2 weeks following implantation|||||||
2680845|NCT01396551|Secondary|To Record Usability Data, Including User Intervention in Response to the Localization and Tracking Data During the Radiation Treatment Sessions|To record usability data, including user intervention in response to the localization and tracking data (e.g., pausing the bean, patient re-alignment, etc.) during the radiation treatment sessions.|Depending on the type of radiation treatment, this will take place over the course of 1-2 weeks or 1-7 weeks|||||||
2680846|NCT01396551|Secondary|To Collect Target Localization and Tracking Data With the Calypso System During Radiation Treatment Sessions|Target localization and tracking data will be collected with the Calypso System during radiation treatment sessions.|Depending on the type of radiation treatment, this will take place over the course of 1-2 weeks or 1-7 weeks|||||||
2680847|NCT01396551|Secondary|To Evaluate Adverse Events Associated With the Anchored Transponder and the Implantation Procedure|Adverse events associated with the anchored transponder and implantation procedure from the time of implantation through the completion of the follow-up period will be recorded and assessed.|Time of implantation through the completion of the follow-up period of the study (0-14 months)|||||||
2680848|NCT01396551|Secondary|To Assess the Positional Stability of the Anchored Transponders Short Term Through the Completion of Radiotherapy and Long Term Through One Year of Follow-up.|The positional stability of the anchored transponder configuration will be assessed using changes in intertransponder distance. Inter-transponder distance will be calculated from CT scans acquired at treatment planning (baseline), 2-4 subsequent follow-up CT scans acquired during radiation therapy, and 4 follow-up CT scans taking place between 10-13 months post-radiotherapy|1-14 months, depending on the duration of radiotherapy and time between follow-up visits.|||||||
2680849|NCT01396551|Secondary|To Assess the Implantation Procedure of the Anchored Transponder in the Lung|The implantation procedure of the anchored transponder in the lung will be assessed with respect to a number of criteria: ability to implant transponders where intended, implanting physician's satisfaction with the process, and geometric configuration of the implanted transponders.|1-2 weeks following implantation|||||||
2680850|NCT01396551|Primary|To Determine the Proportion of Patients Who Can be Localized by the Calypso System Using the Anchored Transponders.|Whether a patient can be localized by the Calypso System using the anchored transponders will be determined during the first week (i.e., the first five fractions) of radiation therapy.|1-2 weeks following implantation|Two patients were not included in the analysis. One patient became ineligible for Calypso localization after receiving a pacemaker, and one patient did not undergo radiation therapy because of disease progression.|||Participants|||Count of Participants
2680851|NCT01396525|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2680852|NCT01396525|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2680853|NCT01396525|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 9 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2680854|NCT01396525|Secondary|Changes in Quality of Life Measures: Mental Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2680868|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.|3 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of target limbs|Participants||Number
2680855|NCT01396525|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2680856|NCT01396525|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2680857|NCT01396525|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 9 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2680858|NCT01396525|Secondary|Changes in Quality of Life Measures: Physical Component Summary|"This measure indicates the absolute change between two timepoints represented by the mean.~SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible."|Baseline and 1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2680859|NCT01396525|Secondary|Stent Thrombosis|Defined as a total occlusion documented by duplex ultrasound and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.|1 month|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target lesions|Participants|95% Confidence Interval|Number
2680860|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.|3 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of target limbs|Participants||Number
2680861|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.|2 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of target limbs|Participants||Number
2680862|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.|18 months|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of target limbs|Participants||Number
2680863|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.|1 month and 9 months|ITT population.This analysis represents those subjects with target limbs who were event free at this timepoint|||percentage of target limbs|Participants||Number
2680864|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Outcome measure analyzed at 1 and 9 months and at 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|3 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2680865|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Outcome measure analyzed at 1 and 9 months and at 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|2 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2680866|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|18 months|ITT population.This analysis represents those subjects who were event free at this timepoint|||percentage of particpants|||Number
2680867|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Embolic Events|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.|1 month and 9 months|ITT population.This analysis represents those subjects who were event free at this timepoint|||percentage of particpants|||Number
2680927|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|2 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2680869|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.|2 years|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of target limbs|Participants||Number
2680870|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.|18 months|ITT population.This analysis represents those subjects with target limbs who were event free at this time point.|||percentage of target limbs|Participants||Number
2680871|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.|1 month and 9 months|ITT population.This analysis represents those subjects with target limbs who were event free at this timepoint|||percentage of target limbs|Participants||Number
2680872|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|3 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2680873|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|2 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2680874|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|18 months|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2680875|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.|1 month and 9 months|ITT population. This analysis represents those subjects who were event free at this timepoint|||percentage of participants|||Number
2680876|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.|3 years|ITT population.This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2680877|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.|2 years|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2680878|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.|18 months|ITT population. This analysis represents those subjects who were event free at this time point.|||percentage of participants|||Number
2680879|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Death (All Cause)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years|1 month and 9 months|ITT population. This analysis represents those subjects who were event free at this timepoint.|||percentage of participants|||Number
2680880|NCT01396525|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|3 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants|95% Confidence Interval|Number
2680881|NCT01396525|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|2 years|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants|95% Confidence Interval|Number
2680882|NCT01396525|Secondary|Restenosis|Defined as ≥ 50% stenosis at follow-up.|9 months|ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants|95% Confidence Interval|Number
2680883|NCT01396525|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure|3 years|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants||Number
2680884|NCT01396525|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure|2 years|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants||Number
2680885|NCT01396525|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|9 months|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants||Number
2680886|NCT01396525|Secondary|Primary Stent Patency|Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.|1 month|ITT population, per lesion analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of limbs|Participants||Number
2687709|NCT01339897|Secondary|Pharmacokinetics of N6022 on Study Day 1|Analysis of N6022 Cmax values on Study Day 1|Day 1, 24 hours||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2680887|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|3 years|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.|||percentage of limbs|Participants||Number
2680888|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|2 years|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.|||percentage of limbs|Participants||Number
2680889|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|18 months|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.|||percentage of limbs|Participants||Number
2680890|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).|1 month and 9 months|ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions who were event free at this timepoint.|||percentage of limbs|Participants||Number
2680891|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically DrivenTarget Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|3 years|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint.|||percentage of target vessels|Participants||Number
2680892|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically Driven Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|2 years|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint.|||percentage of target vessels|Participants||Number
2680893|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography)|18 months|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint|||percentage of target vessels|Participants||Number
2680894|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).|1 month and 9 months|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint|||percentage of target vessels|Participants||Number
2680895|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).|3 years|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.|||percentage of target vessels|Participants||Number
2680896|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).|2 years|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.|||percentage of target vessels|Participants||Number
2680897|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).|18 months|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this time point.|||percentage of target vessels|Participants||Number
2680898|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).|1 month and 9 months|ITT population. This analysis represents those subjects with lesions in target vessels who were event free at this timepoint|||percentage of target vessels|Participants||Number
2680899|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|3 years|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.|||percentage of target lesions|Participants||Number
2680900|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|2 years|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.|||percentage of target lesions|Participants||Number
2680901|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|18 months|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.|||percentage of target lesions|Participants||Number
2680902|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).|1 month and 9 months|ITT population. This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
2680903|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|3 years|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.|||percentage of target lesions|Participants||Number
2680904|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|2 years|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.|||percentage of target lesions|Participants||Number
2680905|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|18 months|ITT population. This analysis represents those subjects with target lesions who were event free at this time point.|||percentage of target lesions|Participants||Number
2680906|NCT01396525|Secondary|Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)|Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years.Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by Duplex ultrasonography (DUS) or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).|1 month and 9 months|ITT population. This analysis represents those subjects with target lesions who were event free at this timepoint.|||percentage of target lesions|Participants||Number
2680907|NCT01396525|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Baseline and 3 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target limbs|Participants||Number
2680908|NCT01396525|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Baseline and 2 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target limbs|Participants||Number
2680909|NCT01396525|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 9 months|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target limbs|Participants||Number
2680910|NCT01396525|Secondary|Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)|"Change in Rutherford Becker Clinical Category:~Worsening Rutherford Becker Clinical Category:~Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.~Improved Rutherford Becker Clinical Category:~An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement."|Between baseline and 1 month|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target limbs|Participants||Number
2680911|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|3 years|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target limbs|Participants||Number
2680912|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|2 years|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target limbs|Participants||Number
2680913|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|9 months|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target limbs|Participants||Number
2680914|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|1 month|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target limbs|Participants||Number
2680915|NCT01396525|Secondary|Rutherford Becker Clinical Category for the Treated Limb(s)|"The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.~Category and Clinical Description:~0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable"|Pre-Procedure|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of target limbs|Participants||Number
2680928|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|9 months|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2680916|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|3 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2680917|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|2 years|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2680918|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|9 months|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2680919|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|1 month|ITT population, per subject analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||score on a scale||Standard Deviation|Mean
2680920|NCT01396525|Secondary|Walking Impairment Questionaire Scores|Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.|Pre-procedure|ITT population, per subject analysis|||score on a scale||Standard Deviation|Mean
2680921|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|Between baseline and 3 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2680922|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.|Between baseline and 2 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2680923|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.|Between baseline and 9 months|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2680924|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.|Between Baseline and 1 month|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2680925|NCT01396525|Secondary|Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)|The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.|Between baseline and Post-procedure|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2680926|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|3 years|ITT population, per limb analysis.The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2680950|NCT01396421|Secondary|Discontinuation Rate for Lack of Efficacy at Week 6||Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.|||Percentage of participants|||Number
2680929|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|1 month|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2680930|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|Post-Procedure|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2680931|NCT01396525|Secondary|Thigh Brachial Index (TBI) for the Treated Limb(s)|The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.|Pre-procedure|ITT population, per limb analysis. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||Ratio|Participants|Standard Deviation|Mean
2680932|NCT01396525|Secondary|Procedure Success|Procedure success is defined as technical success (device success and attainment of a final residual stenosis of < 30% by QA) without complications within two (2) days after the index procedure or at hospital discharge, whichever is sooner.|Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner|ITT population, per subject analysis|||percentage of participants||95% Confidence Interval|Number
2680933|NCT01396525|Secondary|Technical Success|Technical success is defined as device success (the achievement of successful delivery and deployment of the trial device(s) at the intended target lesion(s), successful withdrawal of the delivery catheter(s)), and attainment of a final residual stenosis of < 30% by QA or as reported by the investigator.|Acute: from beginning of index procedure to end of procedure|ITT population, per lesion analysis|||percentage of target lesions|Participants|95% Confidence Interval|Number
2680934|NCT01396525|Secondary|Device Success|On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).|Acute: from beginning of index procedure to end of procedure|ITT population, per device analysis. Included 210 stents plus 1 stent inserted but not implanted due to device malfunction, 2 stents excluded due to inappropriate sizing (stents were not implanted), 1 stent excluded as stent was not implanted per physician's choice and had no device malfunction.|||percentage of devices|Participants|95% Confidence Interval|Number
2680935|NCT01396525|Primary|Major Adverse Event (MAE)|Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).|9 months|Intent to treat (ITT) population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.|||percentage of participants||95% Confidence Interval|Number
2680936|NCT01396512|Secondary|Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine|Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, and Irritability. Grade 3 injection site: Pain - Cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling longest diameter ≥50 mm. Grade 3 systemic reactions: Fever >39.5°C; Vomiting ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal - >3 hours; Drowsiness - sleeping most of the time or difficult to wake; Appetite Loss - refuses ≥3 feeds or most feeds; Irritability - inconsolable.|Day 0 up to Day 14 post-vaccination|Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
2680937|NCT01396512|Secondary|Number of Participants With Seroprotection Against Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine|Immunogenicity was assessed using a Japanese encephalitis chimeric virus (JE-CV) PRNT50 assay. Seroprotection was defined as the percentage of participants with a titer ≥10 (1/dil) at pre-vaccination and at Day 28 post-vaccination.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection against JE-CV was assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2680938|NCT01396512|Secondary|Geometric Mean Titers Against the Japanese Encephalitis Chimeric Virus Before And Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine|"Geometric mean titers were assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50).~JE-CV PRNT50 antibody titer >10 (1/dil, Day 0)"|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean titers against the JE-CV was assessed in the Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2680939|NCT01396512|Primary|Percentage of Participants With Seroconversion to Japanese Encephalitis Chimeric Virus Following Vaccination With Either IMOJEV™ or CD.JEVAX™ Japanese Encephalitis Vaccine|Immunogenicity assessed using a Japanese encephalitis chimeric virus (JE-CV) 50% Plaque Reduction Neutralization Test (PRNT50). Seroconversion was defined as the percentage of participants who developed neutralizing antibody titers above 10 (1/dil) when seronegative at baseline (<1/10) or who presented a ≥4-fold rise in their neutralizing antibody titers when seropositive (≥1/10) at baseline.|Day 28 post-vaccination|Seroconversion to JE-CV was assessed in the Per-Protocol Analysis Set.|||Percentage of Participants|||Number
2680940|NCT01396486|Primary|Improvement in Depression Symptoms by Children's Depression Rating Scale (CDRS)|The Children's Depression Rating Scale (CDRS) is a clinician-rated instrument with 17 items scored on a 1 to 5 or 1 to 7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. Scores of 20-30 suggest borderline depression. Scores of 40-60 indicate moderate depression.|Baseline to endpoint (12 weeks or last observation carried forward if dropped prior to week 12)||||units on a scale||Standard Deviation|Mean
2680941|NCT01396486|Primary|Improvement in Mania Symptoms by Change in Young Mania Rating Scale (YMRS)|The Young Mania Rating Scale (YMRS) consists of 7 items rated on a scale from 0 (symptoms not present) to 4 (symptoms extremely severe) and 4 items rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe).The YMRS score ranges from 0-60. Questions are asked about the last week. A higher score signifies more severe manic symptoms.|Baseline to endpoint (12 weeks or last observation carried forward if dropped prior to week 12)||||units on a scale||Standard Deviation|Mean
2680942|NCT01396447|Secondary|Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6|"The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a normal state and 7 indicating among the most extremely ill participants. A higher score indicates greater illness. A negative change score indicates improvement."|Baseline to Week 6|Intent-to-treat population: All randomized participants who took at least 1 dose of investigational product and had at least 1 post-Baseline assessment of the Montgomery-Åsberg Depression Rating Scale.|||units on a scale||Standard Error|Least Squares Mean
2680943|NCT01396447|Primary|Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6|The Montgomery-Åsberg Depression Rating Scale is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The scores on the 10 items are summed for a total score that can range from 0 to 60. A higher score indicates greater depression. A negative change score indicates improvement.|Baseline to Week 6|Intent-to-treat population: All randomized participants who took at least 1 dose of investigational product and had at least 1 post-Baseline assessment of the Montgomery-Åsberg Depression Rating Scale.|||units on a scale||Standard Error|Least Squares Mean
2680944|NCT01396434|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to 13vPnC were reported. An AE was any untoward medical occurrence in a participant who received 13vPnC. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-SAEs.|Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period|Participants who received at least 1 dose of 13vPnC.|||participants|||Number
2680945|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Anxiety Depression Score|The PANSS Marder Factor score - Anxiety/Depression Score consists of 4 PANSS items (anxiety [G2], guilt feelings [G3], tension [G4], depression [G6]). The PANSS Marder Factor score - Anxiety/Depression Score for participants was calculated as the sum of the rating assigned to each of the 4 items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
2680946|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Uncontrolled Hostility/Excitement Score|The PANSS Marder Factor score - Uncontrolled Hostility/Excitement Score consists of 4 PANSS items (excitement [P4], hostility [P7], uncooperativeness [G8], poor impulse control [G14]). The PANSS Marder Factor score - Uncontrolled Hostility/Excitement Score for participants was calculated as the sum of the rating assigned to each of the 4 items, and ranged from 4 to 28 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
2680947|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Disorganised Thought Score|The PANSS Marder Factor score -Disorganized Thought Score consists of 7 PANSS items (conceptual disorganization [P2], difficulty in abstract thinking [N5], mannerisms and posturing [G5], disorientation [G10], poor attention [G11], disturbance of violation [G13], preoccupation [G15]). The PANSS Marder Factor score - Disorganized Thought Score for participants was calculated as the sum of the rating assigned to each of the 7 items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
2680948|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Score - Negative Symptoms Score|The PANSS Marder Factor score - Negative Symptoms Score consists of 7 PANSS items (blunted effect [N1], emotional withdrawal [N2], poor rapport [N3], passive/apathetic social withdrawal [N4], lack of spontaneity and conversation flow [N6], motor retardation [G7], active social avoidance [G16]). The PANSS Marder Factor score - Negative Symptoms Score for participants was calculated as the sum of the rating assigned to each of the 7 items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
2680949|NCT01396421|Secondary|Change From Baseline to Week 6 in PANSS Marder Factor Score - Positive Symptoms Score|The PANSS Marder Factor score - Positive Symptoms Score consists of 8 PANSS items (delusions [P1], hallucinatory behaviour [P3], grandiosity [P5], suspiciousness [P6], stereotyped thinking [N7], somatic concern [G1], unusual thought content [G9], lack of judgment and insight [G10]. Each was rated on a scale of 1 (absent) to 7 (extreme). The PANSS Marder Factor score - Positive Symptoms Score for participants was calculated as the sum of the rating assigned to each of the 8 items, and ranged from 8 to 42 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
2688129|NCT01335932|Secondary|Patients With Serious Adverse Events|Number of patients with Serious Adverse Events by day 35|by 35 days post-randomization||||Participants|||Count of Participants
2680951|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score|The PEC consists of 5 PANSS items (excitement [P4], hostility [P7], tension [G4], uncooperativeness [G8], and poor impulse control [G14]). Each rated on a scale of 1 (absent) to 7 (extreme). The PEC for participants was calculated as the sum of the rating assigned to each of the 5 items, and ranged from 5 to 35 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
2680952|NCT01396421|Secondary|Response Rate at Week 6|Response rate was defined as improvement in mean change of ≥30% from baseline in PANSS Total Score at Week 6 or CGI-I score of 1 (very much improved) or 2 (much improved) at Week 6.|Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.|||Percentage of participants|||Number
2680953|NCT01396421|Secondary|Clinical Global Impression- Improvement Scale (CGI-I) Score at Week 6|The participant's overall improvement was rated using the CGI-I. The rater or study physician rated the participant's total improvement whether or not it was due entirely to drug treatment. All responses were compared with the participant's condition at screening/baseline. Response choices were: 0=not assessed, 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse.|Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
2680954|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score|For each symptom construct of the PANSS Negative Subscale, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The symptom constructs were as follows: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale Score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
2680955|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score|For each symptom construct of the PANSS Positive Subscale, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The symptom constructs were as follows: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale Score for each participant was calculated as the sum of the rating assigned to each of the 7 subscale items, and ranged from 7 to 49 with a higher score indicating greater severity of symptoms.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 123, 56 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
2680956|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in Personal and Social Performance Scale (PSP)|The PSP is a clinician-rated scale that measures personal and social functioning in 4 domains: socially useful activities (eg, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 122, 55 and 108 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
2680957|NCT01396421|Secondary|Mean Change From Baseline to Week 1, 2, 3, 4 and 5 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.|"The severity of illness was rated using the CGI-S. To perform this assessment, the rater or study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participant."|Baseline to Week 1, 2, 3, 4 and 5|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2680958|NCT01396421|Secondary|Mean Change From Baseline to Week 1, 2, 3, 4 and 5 Positive and Negative Syndrome Scale (PANSS) Total Score.|The PANSS consists of 3 subscales (positive subscale, negative subscale and general psychology subscale) containing a total of 30 symptom constructs and was administered using the Structured Clinical Interview (SCI)-PANSS. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 1, 2, 3, 4, 5|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2681049|NCT01396148|Secondary|Overall Survival|Overall survival was defined as time (in months) from enrollment to the date of death due to any cause. Analysis was performed using Kaplan-Meier method.|Baseline until death or discontinuation from the study whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days)|The full analysis set included all enrolled participants regardless of what treatment, if any, was received.|||months||95% Confidence Interval|Median
2680959|NCT01396421|Secondary|Mean Change From Baseline to Week 6 in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.|"The severity of illness was rated using the CGI-S which is the key secondary endpoint. To perform this assessment, the rater or study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0=not assessed; 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participant."|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 121, 124, 56 and 109 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
2680960|NCT01396421|Primary|Mean Change From Baseline to Week 6 Positive and Negative Syndrome Scale (PANSS) Total Score.|The PANSS consists of 3 subscales (positive subscale, negative subscale and general psychology subscale) containing a total of 30 symptom constructs and was administered using the Structured Clinical Interview (SCI)-PANSS. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline to Week 6|Efficacy: consists of all participants who received at least one dose of study medication and have baseline and at least one post-baseline efficacy evaluation. At Week 6, 134, 132, 62 and 124 participants in the Brex 4mg, Brex 2mg, Brex 0.25 mg and placebo group, respectively had data.|||Units on a scale||Standard Error|Least Squares Mean
2680961|NCT01396395|Secondary|Number of Subjects Who Showed Compliance to Nicorandil|Compliance percent (%) was calculated by using the formula: (actual total dose divided by planned total dose) multiplied by 100. If subject compliance was less than 80% or greater than 120%, then that subject was considered as non compliant. The compliance of subjects taking nicorandil was evaluated.|Baseline up to 12 Weeks|Safety analysis population included all the subjects who received at least one dose of the study drug. 4 subjects randomized to standard+nicorandil group were included in standard group for safety analysis as they did not receive nicorandil. 1 subject randomized to standard group was included in standard+nicorandil group as nicorandil was received.|||subjects|||Number
2680962|NCT01396395|Secondary|Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Death, and AEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as the AEs that occurred between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 30 days after the last dose of study drug administration (up to 16 weeks )|Safety analysis population included all the subjects who received at least one dose of the study drug. 4 subjects randomized to standard+nicorandil group were included in standard group for safety analysis as they did not receive nicorandil. 1 subject randomized to standard group was included in standard+nicorandil group as nicorandil was received.|||subjects|||Number
2680963|NCT01396395|Secondary|Walk Distance in Six Minute Walk (6-MWT) Test at Week 12|The 6-MWT distance was the distance that a subject could walk in 6 minutes. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. The 6-MWT was completed within 1-hour after wearing Holter.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.|||meters||Standard Deviation|Mean
2680964|NCT01396395|Secondary|Number of Nitroglycerin Tablets Consumed in a Week||At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.|||tablets per week||Inter-Quartile Range|Median
2680965|NCT01396395|Secondary|Number of Subjects Relieved From Angina Attack After the Consumption of Nitroglycerin||At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.|||subjects|||Number
2680966|NCT01396395|Secondary|Frequency of Angina Attack|The total number of times angina attacks occurred within a week (number of times/week)|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.|||angina attacks per week||Inter-Quartile Range|Median
2680967|NCT01396395|Secondary|Number of Subjects Experienced Angina Attack||Baseline up to 12 Weeks|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.|||subjects|||Number
2680968|NCT01396395|Secondary|ECG QT Dispersion|The ECG QT dispersion was defined as the difference between the longest (QTmax) and the shortest (QTmin) QT intervals within a 12‐lead ECG.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.|||milliseconds||Standard Deviation|Mean
2680969|NCT01396395|Secondary|Number of Arrhythmia Occurred Within 24 Hours|The number of ventricular tachycardia and premature ventricular beats that occurred within 24 hours.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.|||beats per 24 hours||Standard Deviation|Mean
2680970|NCT01396395|Secondary|Heart Rate Variability (HRV) Rate: Frequency Domain Power-24 Hour|HRV is the degree of fluctuation in the length of the intervals between heart beats. All HRV parameters are calculated on 'normal-to-normal' (NN) inter-beat intervals (or NN intervals) caused by normal heart contractions. The HRV was evaluated based on frequency domain power-24 hours.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.|||millisecond square (ms^2)||Standard Deviation|Mean
2680971|NCT01396395|Secondary|Heart Rate Variability (HRV) Rate: Time Domain|HRV is the degree of fluctuation in the length of the intervals between heart beats. All HRV parameters are calculated on 'normal-to-normal' (NN) inter-beat intervals (or NN intervals) caused by normal heart contractions. Standard deviation of all NN intervals (SDNN) and Standard deviation of the averages of NN intervals (SDANN) are the two time domain methods used to determine heart rate variability. Two variants of the SDNN, created by dividing the 24-hour monitoring period into 5-minute segments, are the SDNN index and the SDANN index. The SDNN index is the mean of all the 5-minute standard deviations of NN (normal RR) intervals during the 24-hour period, while the SDANN index is the standard deviation of all the 5-minute NN interval means.|At Week 12|"FAS included all randomized subjects who received at least one dose of study treatment. n signifies the number of subjects evaluable for each category in each group for this outcome measure, respectively."|||millisecond||Standard Deviation|Mean
2680972|NCT01396395|Secondary|Percentage of Subjects Experienced Ischemic Heart Attack During the Six-minute Walk Test|The percentage of subjects who experienced ischemic heart attack during the Six-minute walk test (6-MWT) were evaluated.The 6-MWT was the distance that a subject could walk in 6 minutes. Subjects were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed. The 6-MWT was completed within 1-hour after wearing Holter.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.|||percentage of subjects|||Number
2680973|NCT01396395|Secondary|Change From Baseline in Longest Duration of ST Segment Depression at Week 12|The maximum ST- depression was evaluated from sum of all leads for all the subjects with myocardial ischemia attack. The longest duration of ST segment depression of all leads for all the subjects with myocardial ischemia attack.|Baseline, Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.|||seconds||Standard Deviation|Mean
2680974|NCT01396395|Secondary|Change From Baseline in Maximum ST-depression at Week 12|The maximum ST- depression was evaluated from sum of all leads for all the subjects with myocardial ischemia attack. Absolute value of maximum ST-depression was used for calculation.|Baseline, Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.|||millimeter||Standard Deviation|Mean
2680975|NCT01396395|Secondary|Change From Baseline in Total Myocardial Ischemic Burden at Week 12|The total myocardial ischemic burden was defined as the product of the decrease, total array and total time of ST-segment in symptomatic and asymptomatic myocardial ischemia subjects within 24 hours.|Baseline, Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure. Analysis was done only for subjects with myocardial ischemia attack.|||millimeter*minutes||Standard Deviation|Mean
2680976|NCT01396395|Primary|Number of Myocardial Ischemia Attacks in 24 Hours|Myocardial ischemia attack was evaluated by 24-hour Holter monitoring based on the following criteria: 0.08 seconds after the J point in electrocardiogram (ECG) or compared with baseline levels, ST-segment with horizontal or downward sloping down greater than or equal to (>=) 0.1 millivolts (mV), and lasted for >= 1 minute, and at least 1 minute of interval with another ischemic attack, as one array myocardial ischemia.|At Week 12|FAS included all randomized subjects who received at least one dose of study treatment. N (number of subjects analyzed) signifies the number of subjects evaluable for this outcome measure.|||ischemic attacks per 24 hours||Standard Deviation|Mean
2680977|NCT01396382|Primary|Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan|Determine if the 68Ga-DOTATATE PET scan changes patient care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT, U/S).|at 1 year|A major change in management is defined as:planned surgery cancelled, added, or a different type of surgery was planned, or a medication was added or stopped, or a new treatment modality (e.g. radiation) was added. A minor change was adjustment to planned surgery or radiation field, or in current medication dosage.|||participants|||Number
2680978|NCT01396382|Secondary|Number of Severe Adverse Events Occurences Resulting in Changes to Patient Treatment Plans, as a Measure of Safety and Tolerability|Determine if any adverse effects are associated with the 68Ga-DOTATATE PET scan and the number of patients that experience them using NCI Common Terminology Criteria for Adverse Events v4.0, where: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life‐threatening; Grade 5, death. Toxicities present at baseline and continuing without change in grade were excluded for assessment of this outcome measure.|at 1 year||||participants|||Number
2680979|NCT01396317|Secondary|Total Number of Relapses/Recurrences||12 months||||Incidents|||Number
2680980|NCT01396317|Secondary|The Cumulative Dose of Prednisone||6, 12 and 15 months from trial entry||||milligrams||Standard Deviation|Mean
2680981|NCT01396317|Secondary|Proportion of Patients Who Develop Disease Relapses|Relapse was defined as the reappearance of signs and symptoms of PMR, accompanied by an increasing erythrocyte sedimentation rate and/or C-reactive\ protein level attributable to disease activity. Recurrence was similarly defined as the return of PMR symptoms in conjunction with elevations in levels of inflammation markers, occurring 1 month after discontinuation of GC therapy.|6, 12 and 15 months from trial entry||||Participants|||Count of Participants
2680982|NCT01396317|Secondary|Proportion of Patients Able to Achieve Disease Remission (DR) Off Corticosteroids, Without Disease Relapse or Recurrence||12 and 15 months from trial entry||||Participants|||Count of Participants
2680983|NCT01396317|Primary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|"The co-primary endpoints for this study include evaluations of safety and tolerability:~• Safety and tolerability of Tocilizumab will be evaluated during the fifteen-month study period by the monitoring of adverse events and immunogenicity surveillance"|15 months||||Number of Adverse Events|||Number
2681058|NCT01396148|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) for Sunitinib and Its Metabolite|SU012662 is the metabolite of Sunitinib.|Cycle 1 Day 1: pre-dose, 2, 4, 6, and 8 hours post-dose|The PK population included all treated participants with at least one PK observation.|||hours||Full Range|Median
2680984|NCT01396317|Primary|Proportion of Patients in Disease Remission at Six Months From Trial Entry|"The co-primary endpoints for this study include efficacy:~• Efficacy will be defined by the proportion of patients in Disease Remission (DR) off corticosteroids, without relapse or recurrence, at six months from trial entry~Relapse was defined as the reappearance of signs and symptoms of PMR, accompanied by an increasing erythrocyte sedimentation rate and/or C-reactive protein level attributable to disease activity. Recurrence was similarly defined as the return of PMR symptoms in conjunction with elevations in levels of inflammation markers, occurring 1 month after discontinuation of glucocorticoid therapy."|Six months||||Participants|||Count of Participants
2680985|NCT01396265|Secondary|Apparent Volume of Distribution During the Terminal Phase lambda_z Following an Extravascular Dose (V_z/F)|V_z/F represents the apparent volume of distribution during the terminal phase λz following an extravascular dose|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||Litres||Geometric Coefficient of Variation|Geometric Mean
2680986|NCT01396265|Secondary|Apparent Clearance of Afatinib in the Plasma After Extravascular Administration (CL/F)|CL/F represents the apparent clearance of the analyte in the plasma after extravascular administration|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2680987|NCT01396265|Secondary|Mean Residence Time of Afatinib in the Body After Oral Administration (MRTpo)|MRTpo represents the mean residence time of the analyte in the body after oral administration|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||hours||Geometric Coefficient of Variation|Geometric Mean
2680988|NCT01396265|Secondary|Percentage of the AUCtz-∞ Obtained by Extrapolation (%AUCtz-∞)|%AUCtz-∞ represents the percentage of the AUCtz-∞ obtained by extrapolation|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||percentage of AUCtz-∞||Geometric Coefficient of Variation|Geometric Mean
2680989|NCT01396265|Secondary|Area Under Curve From 0 to 24 h (AUC0-24)|AUC0-24 represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 hours (h)|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2680990|NCT01396265|Secondary|Terminal Half-life of Afatinib in Plasma (t1/2)|t1/2 represents the terminal half-life of the analyte in plasma|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||hours||Geometric Coefficient of Variation|Geometric Mean
2680991|NCT01396265|Secondary|Time From Dosing to the Maximum Concentration of Afatinib in Plasma (Tmax)|tmax represents the time from dosing to the maximum concentration of the analyte in plasma|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||hours||Full Range|Median
2680992|NCT01396265|Primary|Maximum Concentration (Cmax)|Cmax represents the maximum concentration of the analyte in plasma.|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2680993|NCT01396265|Primary|Area Under Curve From 0 to tz (AUC0-tz)|AUC0-tz represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2680994|NCT01396265|Primary|Area Under Curve From 0 to Infinity Hours (AUC0-∞)|AUC0-∞ represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.|0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose|PK analysis set - all subjects of the treated set who provided at least 1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations relevant to the evaluation for PL, and who did not experience vomiting at or before 2 times median tmax for afatinib.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2680995|NCT01396239|Post-Hoc|Frequency of AEs Related to Eteplirsen|Frequency of AEs that the study physician considered to be any of the following: Related; Possibly related; or Probably related to eteplirsen.|24 Weeks||||Number of patients|||Number
2680996|NCT01396239|Post-Hoc|Adverse Events >30%|Adverse events that occurred in >30% of the overall patient population across treatment arms.|24 Weeks||||Number of patients|||Number
2680997|NCT01396239|Secondary|Change From Baseline: 6 Minute Walk Test (6MWT) - Modified Intent to Treat Population (mITT)|A key secondary efficacy endpoint will be based on the pre-treatment and post-treatment of the 6-MWT distance. Change from baseline: 6 Minute Walk Test (6MWT) - modified Intent-to-Treat population (mITT).|24 weeks|The mITT population excludes 2 patients in the 30mg/kg arm who showed rapid disease progression within weeks of enrollment, and were unable to complete assessments that required ambulation at or beyond Week 24.|||Meters||Standard Error|Mean
2680998|NCT01396239|Secondary|Change From Baseline: 6 Minute Walk Test (6MWT) - Intent to Treat Population (ITT)|A key secondary efficacy endpoint will be based on the pre-treatment and post-treatment Change from baseline: 6 Minute Walk Test (6MWT) - Intent to Treat population (ITT)|24 weeks||||Meters||Standard Error|Mean
2680999|NCT01396239|Primary|Change in the Number (%) of Dystrophin Positive Fibers|The primary efficacy endpoint will be based on the pre-treatment and post-treatment change in the number (%) of dystrophin positive fibers as measured in the muscle biopsy tissue on immunohistochemistry (IHC).|After 12 weeks for 4 patients who received 50 mg/kg and 2 patients who received placebo. After 24 weeks for 4 patients who received 30 mg/kg and 2 patients who received placebo.|The sample size for the study was selected based on Proof of Principal approach.|||percentage of dystrophin Pos. fibers||Full Range|Least Squares Mean
2681000|NCT01396226|Secondary|Paced QT Interval|Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements|Baseline to last assessment during IP infusion|PP|||msec||Standard Deviation|Mean
2681001|NCT01396226|Secondary|Ventricular Effective Refractory Period|Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion|Baseline to last assessment during IP infusion|PP|||msec||Standard Deviation|Mean
2681002|NCT01396226|Primary|Left Atrial Effective Refractory Period|Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion|Baseline to last assessment during IP infusion|Per Protocol (PP)|||msec||Standard Deviation|Mean
2681003|NCT01396226|Secondary|RR Interval|Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion|Baseline to last assessment during IP infusion|FAS|||msec||Standard Deviation|Mean
2681004|NCT01396226|Secondary|QRS Duration|Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion|Baseline to last assessment during IP infusion|FAS|||msec||Standard Deviation|Mean
2681005|NCT01396226|Secondary|PR Interval|Interval from the onset of the P-wave to the start of the QRS complex. Change from observation before IP infusion to 6 to 8 hours and 20 to 24 hours after IP infusion|Baseline to last assessment during IP infusion|FAS|||msec||Standard Deviation|Mean
2681006|NCT01396226|Secondary|HV Interval|Change from observation before IP infusion to 30 mins after IP start. HV interval - represents conduction time from the proximal His bundle to the ventricular myocardium, ie, infra-nodal conduction time.|Baseline to last assessment during IP infusion|FAS|||msec||Standard Deviation|Mean
2681007|NCT01396226|Secondary|AH Interval|Change from observation before IP infusion to 30 mins after IP start. AH interval- the conduction time from the low right atrium at the inter-atrial septum through the AV node to the His bundle, ie, intra-nodal conduction time.|Baseline to last assessment during IP infusion|FAS|||msec||Standard Deviation|Mean
2681008|NCT01396226|Secondary|PA Interval|Reflects intra-atrial conduction and is defined as the interval from the onset of the P wave in the surface ECG to the onset of atrial activation (A) in the His bundle electrogram. Change from observation before IP infusion to 30 min after IP start|Baseline to last assessment during IP infusion|FAS|||msec||Standard Deviation|Mean
2681009|NCT01396226|Secondary|Atrio-ventricular Effective Refractory Period|Change from observation before IP infusion to during 1st and 2nd LAERP Mean|Baseline to last assessment during IP infusion|FAS|||msec||Standard Deviation|Mean
2681010|NCT01396226|Secondary|Paced QT Interval|Change in CS Paced QT interval (P600 MS) from before and after IP infusion during electrophysiological measurements|Baseline to last assessment during IP infusion|FAS|||msec||Standard Deviation|Mean
2681011|NCT01396226|Secondary|Ventricular Effective Refractory Period|Change in VERP from before IP infusion to 1st and 2nd assessments during IP infusion|Baseline to last assessment during IP infusion|FAS|||msec||Standard Deviation|Mean
2681012|NCT01396226|Primary|Left Atrial Effective Refractory Period|Change in LAERP from before IP infusion to 1st and 2nd assessments during IP infusion|Baseline to last assessment during IP infusion|Full A analysis Set (FAS)|||msec||Standard Deviation|Mean
2681013|NCT01396187|Secondary|Average Plasma Concentration (Cav) of PF-05231023 at Steady State|Participants who received PF-05231023 with C-terminal and N-terminal Cmax at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Geometric Mean
2681014|NCT01396187|Secondary|Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 at Steady State|Participants who received PF 05231023 with C-terminal and N-terminal Cmax at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Geometric Mean
2681015|NCT01396187|Secondary|Volume of Distribution of PF-05231023 at Steady State (Vss)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vss is the apparent volume of distribution at steady-state. PF-05231023 with C-terminal and N-terminal Vss at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|"PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. n signifies those participants who were evaluated for this measure at the specified terminal for each arm."|||liter||Standard Deviation|Geometric Mean
2682732|NCT01381679|Secondary|Change From Baseline in HDL-C at Month 12||Baseline and Month 12|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C.|||mg/dL||95% Confidence Interval|Mean
2681016|NCT01396187|Secondary|Apparent Clearance (CL) of PF-05231023 at Steady State|Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Participants who received PF-05231023 with C-terminal and N-terminal CL at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||liter per hour||Standard Deviation|Geometric Mean
2681017|NCT01396187|Secondary|Plasma Terminal Half-Life (t1/2) of PF-05231023 at Steady State|Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half at the terminal phase. Participants who received PF-05231023 with C-terminal and N-terminal t1/2 at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|"PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. n signifies those participants who were evaluated for this measure at the specified terminal for each arm."|||hour||Standard Deviation|Mean
2681018|NCT01396187|Secondary|Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF- 05231023|Accumulation ratio based on maximum plasma concentration (Cmax) was calculated as: Rac,Cmax = Cmax at steady state (Day 25) divided by Cmax at first dose (Day 1). Participants who received PF-05231023 with C-terminal and N-terminal Rac,Cmax at steady state were reported.|0 hour (pre-dose) on Day 1, 4, 25; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1, 25; Day 2, 3, 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ratio||Standard Deviation|Geometric Mean
2681019|NCT01396187|Secondary|Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval of PF-05231023 (Rac)|Rac was obtained from AUCtau at steady state (Day 25) divided by AUCtau after single dose (Day 1). AUCtau was the area under the concentration-time profile from time zero to end of dosing interval, where tau = 72 hours for Day 1 and tau = 96 hours for Day 25. Participants who received PF-05231023 with C-terminal and N-terminal Rac at steady state were reported.|0 hour (pre-dose) on Day 1, 4, 25; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1, 25; Day 2, 3, 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ratio||Standard Deviation|Geometric Mean
2681020|NCT01396187|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023 at Steady State|Participants who received PF 05231023 with C-terminal and N-terminal Cmax at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng/mL||Standard Deviation|Geometric Mean
2681021|NCT01396187|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 at Steady State|Participants who received PF-05231023 with C-terminal and N-terminal Tmax at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||hour||Full Range|Median
2681022|NCT01396187|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05231023 at Steady State|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) at steady state. Participants who received PF-05231023 with C-terminal and N-terminal AUClast at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Geometric Mean
2681023|NCT01396187|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 at Steady State|Participants who received PF-05231023 with C-terminal and N-terminal AUCtau at steady state were reported.|0 hour (pre-dose) 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 25; Day 26, 29|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||ng*hr/mL||Standard Deviation|Geometric Mean
2681024|NCT01396187|Secondary|Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose|Participants who received PF 05231023 with C-terminal and N-terminal Cmax were reported.|0 hour (pre-dose) on Day 1, 4; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1; Day 2, 3|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2681025|NCT01396187|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose|Participants who received PF-05231023 with C-terminal and N-terminal Tmax were reported.|0 hour (pre-dose) on Day 1, 4; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1; Day 2, 3|PK parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest.|||hour||Full Range|Median
2681026|NCT01396187|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose|Participants who received PF-05231023 with C-terminal and N-terminal AUCtau were reported.|0 hour (pre-dose) on Day 1, 4; 0.5, 1 (end of infusion), 1.5, 2, 3, 5, 9, 13 hours post-start of infusion on Day 1; Day 2, 3|Pharmacokinetic (PK) parameter analysis set included all enrolled and treated participants who had at least 1 of the PK parameters of interest.|||nanogram*hour per milliliter (ng*hr/mL)||Standard Deviation|Geometric Mean
2681027|NCT01396187|Primary|Number of Participants With Blood Glucose Abnormalities|Criteria for blood glucose abnormality: Blood glucose levels <0.6* LLN or >1.5* ULN.|Baseline up to Day 32|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2681028|NCT01396187|Primary|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (>=) 300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia's Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum increase of >=25 percent (%) for baseline value of >200 msec and >=50% for baseline value of less than or equal to (<=) 200 msec for PR interval, maximum increase from baseline of >=50% for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia's Correction).|Baseline up to Day 77|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2681029|NCT01396187|Primary|Number of Participants With Vital Signs Abnormalities|Criteria for vital signs abnormalities: supine systolic blood pressure (SBP) <90 millimeter of mercury (mm Hg), supine diastolic BP (DBP) <50 mm Hg, supine pulse rate <40 beats per minute (bpm), > 120 bpm. Maximum increase or decrease from baseline in supine SBP >=30 mm Hg and maximum increase or decrease from baseline in supine DBP >=20 mm Hg.|Baseline up to Day 77|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2681030|NCT01396187|Primary|Number of Participants With Abnormal Laboratory Values|Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(less than [<] 0.8*lower limit of normal[LLN]); leucocytes (<0.6/greater than [>]1.5*upper limit of normal [ULN]); platelets (<0.5*LLN></0>1.75*ULN); neutrophils, lymphocytes (<0.8*LLN></0>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN), total protein, albumin (<0.8*LLN></0>1.2*ULN); creatinine, urea (>1.3*ULN); glucose (<0.6*LLN></0>1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN></0>1.1*ULN); urine RBCs, urine white blood cells (WBCs) (> or equal[=]20 high-powered field), urine bacteria >20 high-powered field. Total number of participants with any laboratory abnormalities were reported.|Baseline up to Day 42|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2681031|NCT01396187|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 77 which were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Day 77|Safety population included all participants who received at least 1 dose of study medication.|||participants|||Number
2681032|NCT01396187|Primary|Number of Participants With Abnormal Physical Examination Findings|Physical examination included assessment of height, weight, blood pressure, pulse rate and body temperature. Criteria for abnormal physical findings was based on investigator's discretion and were reported as adverse event (AE), as planned.|Baseline up to Day 42|Physical examination data reported in this study was for identification of adverse events and were reported as adverse event in the AE section.||||||
2681033|NCT01396161|Secondary|Urinary Recovery|Percentage of PF-05175157 excreted unchanged in urine over the dosing interval.|Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|PKP analysis population; Participants Analyzed (N): number of participants with evaluable data|||percentage||Standard Deviation|Mean
2681034|NCT01396161|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|It was not possible to calculate data for half-life as the calculation required the slope of terminal elimination phase and the PK sampling was insufficient to characterize the terminal elimination phase, which is needed for the calculation of the half-life.||||||
2681035|NCT01396161|Secondary|Renal Clearance (CLr)|CLr is the amount of unchanged drug excreted in the participants urine from time zero to end of dosing interval.|Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|PKP analysis population; Participants Analyzed (N): number of participants with evaluable data|||mL/min||Standard Deviation|Mean
2681036|NCT01396161|Secondary|Accumulation Ratio for Area Under the Concentration-Time Curve (Rˇac, AUC)|Rˇac for the AUC is defined as AUC (τ, single dose [ss]) / AUC (τ, multiple dose [sd]).|Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|PKP analysis population; Participants Analyzed (N): number of participants with evaluable data|||ratio||Standard Deviation|Mean
2681037|NCT01396161|Secondary|Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)||Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|PKP analysis population; Participants Analyzed (N): number of participants with evaluable data|||µg times (*)hr divided by mL (µg *hr/mL)||Standard Deviation|Mean
2681038|NCT01396161|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|Pharmacokinetic Parameter (PKP) Analysis Population: all enrolled participante who received at least 1 dose of PF05175157 and had at least 1 PKP of interest calculated;Number of Participants Analyzed (N): number of participants with evaluable data|||hours (hrs)||Full Range|Median
2681039|NCT01396161|Secondary|Maximum Observed Plasma Concentration (Cmax)||Hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 1 and 14; at Hour 0 (pre-dose), 3.5, 12 hours post-dose for Day 4, 7 and 11|Pharmacokinetic Concentration (PKC) Analysis Population: all enrolled participants who received at least 1 dose of PF-05175157 and had at least 1 concentration value reported. Number of Participants Analyzed (N): number of participants with evaluable data|||micrograms per milliliter (µg/mL)||Standard Deviation|Mean
2682733|NCT01381679|Secondary|Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3||Baseline and Month 3|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for HDL-C.|||mg/dL||95% Confidence Interval|Mean
2681040|NCT01396161|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to PF-05175157 was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.|2 weeks|Safety Analysis Set: all participants who received at least 1 dose of study medication (PF-05175157 or placebo).|||participants|||Number
2681041|NCT01396148|Secondary|Estimated Sunitinib Plasma Concentration at Which 50% of the Maximum Effect (EC50) for Each Selected Safety Endpoint (e.g., Absolute Neutrophil Count) Was Observed||Cycle 1 Day 1: pre-dose, 2, 4, 6, and 8 hours post-dose|Due to low number of enrolled participants (n=6), there was insufficient data to perform any type of pharmacokinetic/pharmacodynamic modeling to obtain EC50 values, hence data is not reported.||||||
2681042|NCT01396148|Secondary|Estimated Sunitinib Plasma Concentration at Which 50% of the Maximum Effect (EC50) for Each Selected Efficacy Parameter (e.g., Sum of Largest Diameters for Target Tumors) Was Observed||Cycle 1 Day 1: pre-dose, 2, 4, 6, and 8 hours post-dose|Due to low number of enrolled participants (n=6), there was insufficient data to perform any type of pharmacokinetic/pharmacodynamic modeling to obtain EC50 values, hence data is not reported.||||||
2681043|NCT01396148|Secondary|Pearson Correlation Coefficient Between Progression Free Survival With Total Drug (Sunitinib + SU012662) Concentration|Pearson correlation coefficient between Progression Free Survival (PFS) with total drug (Sunitinib + SU012662) concentration at Day 28 of Cycle 1 was calculated. PFS was defined as time (in months) from date of enrolment to the first documentation of disease progression or to death (due to any cause), whichever occurred first. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days|The PK population included all treated participants with at least one PK observation.|||correlation coefficient|||Number
2681044|NCT01396148|Secondary|Progression Free Survival for PK Subgroups|Progression free survival was defined as time (in months) from date of enrollment to the first documentation of disease progression or to death (due to any cause), whichever occurred first. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The PK evaluable participants were assessed according to 2 PK subgroups created on Day 28 of Cycle 1: those with total drug (sunitinib + SU012662) trough plasma concentration (Ctrough) value less than (<) the median Ctrough value(lower exposure) and those with total drug (sunitinib + SU012662) Ctrough values greater than or equal to (>=) the median Ctrough value(higher exposure).|Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days)|The PK population included all treated participants with at least one PK observation.|||months||95% Confidence Interval|Median
2681045|NCT01396148|Secondary|Number of Participants With Stable Disease (SD), Partial Response (PR), Complete Response (CR) and Progressive Disease (PD) for PK Sub-groups|SD:when there is no sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PR: as at least 30% decrease in the sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non-target lesions not increased or absent. CR: disappearance of all lesions (target and non-target). PD:at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Participants with SD, PR, CR and PD responses were assessed according to 2 PK subgroups created on Day 28 of Cycle 1: those with total drug (sunitinib + SU012662) trough plasma concentration (Ctrough) value less than (<) the median Ctrough value(lower exposure) and those with total drug (sunitinib + SU012662) Ctrough values greater than or equal to (>=) the median Ctrough value(higher exposure).|Baseline until disease progression or discontinuation from the study, or death, whichever occurred first(maximum duration: up to Cycle 18; each cycle was of 42 days)|The PK population included all treated participants with at least 1 PK observation.|||participants|||Number
2681046|NCT01396148|Secondary|Pearson Correlation Coefficient Between Percent Change From Baseline in Vital Sign Results With Total Drug (Sunitinib + SU012662) Concentration|Pearson correlation coefficient between percent change from baseline in vital sign results with total drug (Sunitinib + SU012662) concentration were calculated on Day 28 of Cycles 1, 2, and 3. Vital signs included systolic blood pressure and diastolic blood pressure.|Baseline, Day 28 of Cycle 1, Cycle 2 and Cycle 3 (each cycle was of 42 days)|The PK population included all treated participants with at least one PK observation.|||correlation coefficient|||Number
2681047|NCT01396148|Secondary|Pearson Correlation Coefficient Between Percent Change From Baseline in Laboratory Parameters With Total Drug (Sunitinib + SU012662) Concentration|Pearson correlation coefficient between percent change from baseline in laboratory parameters with total drug (Sunitinib + SU012662) concentration were calculated on Day 28 of Cycles 1, 2, and 3. Laboratory parameters included absolute neutrophil count, platelet count, lymphocyte count and hemoglobin.|Baseline, Day 28 of Cycle 1, Cycle 2 and Cycle 3 (each cycle was of 42 days)|The PK population included all treated participants with at least one PK observation.|||correlation coefficient|||Number
2681048|NCT01396148|Secondary|Number of Participants With Adverse Events Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) for Pharmacokinetic (PK) Subgroups|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE version 4.0, Grade1= asymptomatic or mild symptoms, Grade 2= Moderate;local or noninvasive intervention indicated; Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. Participants with any of the Grade 1 to Grade 5 AEs were reported. The PK evaluable participants were divided into 2 PK subgroups on Day 28 of Cycle 1: those with total drug (sunitinib + SU012662) trough plasma concentration (Ctrough) value less than (<) the median Ctrough value(lower exposure) and those with total drug (sunitinib + SU012662) Ctrough values greater than or equal to (>=) the median Ctrough value(higher exposure).|Cycle 1 Day 28 up to Cycle 3 (each cycle 42 days)|The PK subgroup analysis set included all treated participants with at least 1 PK observation.|||participants|||Number
2681050|NCT01396148|Secondary|Progression-Free Survival|Progression free survival was defined as time (in months) from date of enrollment to the first documentation of disease progression or to death (due to any cause), whichever occurred first. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days)|The full analysis set included all enrolled participants regardless of what treatment, if any, was received.|||months||95% Confidence Interval|Median
2681051|NCT01396148|Secondary|Duration of Response|Duration of response was defined as time (in months) from the first documentation of objective tumor response (confirmed CR or PR) to the first documentation of disease progression or death due to any cause. Confirmed response were those that persisted on repeat imaging study for at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and non-target). PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non-target lesions not increased or absent. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).|Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days)|Analysis was performed on a subset of FAS which included participants who had a confirmed CR or PR. Since, none of the participants had confirmed CR or PR, hence duration of response was not analyzed.||||||
2681052|NCT01396148|Secondary|Number of Participants With Objective Response|Objective response in participants was defined as the number of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Confirmed response were those that persisted on repeat imaging study for at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and non-target). PR was defined as at least 30 percentage (%) decrease in the sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non-target lesions not increased or absent.|Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days)|The full analysis set included all enrolled participants regardless of what treatment, if any, was received.|||participants|||Number
2681053|NCT01396148|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities|Criteria for clinically significant laboratory abnormalities: Hemoglobin (Hb), hematocrit: less than (<) 0.8*lower limit of normal (LLN), platelet: <75 or greater than (>) 700*10^3/millimeter (mm)^3*upper limit of normal (ULN), leukocyte: <2.5 or >17.5*10^3/mm^3*ULN; total bilirubin 1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase: >3.0*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN ;blood urea nitrogen, creatinine: >1.3*ULN, uric acid >1.2*ULN; sodium <0.95*LLN or >1.05*ULN, potassium, calcium: <0.9*LLN or >1.1*ULN, albumin, total protein <0.8*LLN or >1.2*ULN; glucose <0.6*LLN or >1.5*ULN, creatine kinase >2.0*ULN; urine (red blood cell, white blood cell >6/high power field).|Baseline up to end of study (up to Cycle 18, each cycle was of 42 days)|The as-treated population included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2681054|NCT01396148|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious adverse events (AEs) and SAEs.|Baseline up to end of study (up to Cycle 18, each cycle was of 42 days)|The as-treated population included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2681055|NCT01396148|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE), Version 4.0|An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE, Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. Treatment-emergent events are events between first dose of study drug and up to end of study (up to Cycle 18) that were absent before treatment or that worsened relative to pretreatment state. Number of participants with AEs of any of the Grade 3 or above (Grade 4, 5) were reported.|Baseline up to end of study (up to Cycle 18, each cycle was of 42 days)|The as-treated population included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2681056|NCT01396148|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to end of study (up to Cycle 18) that were absent before treatment or that worsened relative to pretreatment state. AEs included both non-serious adverse events (AEs) and SAEs.|Baseline up to end of study (up to Cycle 18, each cycle was of 42 days)|The as-treated population included all enrolled participants who received at least 1 dose of study drug.|||participants|||Number
2681057|NCT01396148|Primary|Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours Post Dose AUC(0-8) for Sunitinib and Its Metabolite|AUC(0-8) was defined as area under the plasma concentration time-curve from time zero to 8 hours post dose. SU012662 is the metabolite of Sunitinib.|Cycle 1 Day 1: pre-dose, 2, 4, 6, and 8 hours post-dose|The PK population included all treated participants with at least one PK observation.|||nanograms*hour per milliliter (ng*hr)/mL||Geometric Coefficient of Variation|Geometric Mean
2688161|NCT01335932|Secondary|CMV Peak Viral Load in Blood|CMV Peak Viremia in blood at day 28|at 28 days post-randomization||||log 10 IU/mL||Standard Deviation|Mean
2681060|NCT01396148|Primary|Estimated Oral Clearance (CL/F) of Sunitinib and Its Metabolite|SU012662 is the metabolite of Sunitinib. Oral clearance (CL/F) is a quantitative measure of the rate at which a drug substance is removed from the blood (CL) normalized by the oral bioavailability of the drug (F). Summarized data for all time points was reported.|pre-dose on Day 1, Day 12-18 and Day 25-29 of Cycle 1,2, 3 and 2, 4, 6, 8 hours post-dose on Day 1 Cycle 1|The PK population included all treated participants with at least one PK observation.|||Liters per hour (L/hr)||Standard Deviation|Mean
2681061|NCT01396148|Primary|Estimated Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose AUC(0-24) of Sunitinib and Its Metabolite|Estimated area under the plasma concentration versus time curve from time zero to 24 hours post dose (AUC24) of Sunitinib and its metabolite SU012662. Summarized data for all time points was reported.|pre-dose on Day 1, Day 12-18 and Day 25-29 of Cycle 1,2, 3 and 2, 4, 6, 8 hours post-dose on Day 1 Cycle 1|The PK population included all treated participants with at least one PK observation.|||nanogram*hour per milliliter (ng*hr)/mL||Standard Deviation|Mean
2681062|NCT01396148|Primary|Estimated Steady-State Maximum Plasma Concentration (Cmax,ss) of Sunitinib and Its Metabolite|Estimated steady-state maximum plasma concentration (Cmax,ss) of Sunitinib and its metabolite SU012662. Summarized data for all time points was reported.|pre-dose on Day 1, Day 12-18 and Day 25-29 of Cycle 1,2, 3 and 2, 4, 6, 8 hours post-dose on Day 1 Cycle 1|The PK population included all treated participants with at least one PK observation.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2681063|NCT01396083|Secondary|Increase Rate of the Internal Ocular Pressure (IOP ) : Patients With ≥10% Increase in IOP Compared to Baseline|The proportion of patients with ≥ 10% increase in Internal Ocular Pressure (IOP) compared to baseline at any post-baseline visit.|Baseline, month 6|The Safety Set consisted of all patients from the RS who had received at least one application of study treatment and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no adverse events also constituted a safety assessment|||Participants|||Number
2681064|NCT01396083|Secondary|Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires|The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Observed participants are only described in this analysis|||Units on a scale||Standard Deviation|Mean
2681065|NCT01396083|Secondary|Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires|SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. observed is only described in this analysis.|||Units on a scale||Standard Deviation|Mean
2681066|NCT01396083|Secondary|Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires|The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Score on a scale||Standard Deviation|Mean
2681067|NCT01396083|Secondary|Change Over Time of the Central Retinal Thickness (CRT)|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||µm||Standard Deviation|Mean
2681068|NCT01396083|Secondary|Change Over Time in BCVA|The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||letters||95% Confidence Interval|Least Squares Mean
2681069|NCT01396083|Secondary|Time to Achieve a Significant Improvement ≥ 15 Letters|The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Time to event (Days)||95% Confidence Interval|Median
2681070|NCT01396083|Secondary|Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the number of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline|Baseline, 6 month|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Participants|||Number
2681122|NCT01395784|Primary|"Subjective Ratings of Good Drug Effect"|Visual analog scale ratings (0-100 mm scale, 0=Not at all, 100=Extremely)|Measured during the lab session conducted at the end of each maintenance period|Shown below are peak drug effects from each of the 3 maintenance periods (Placebo, Pioglitazone (PIO) 15, and PIO 45)|||units on a scale||Standard Deviation|Mean
2681071|NCT01396083|Secondary|Mean BCVA Change at Month 6|The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Letters||95% Confidence Interval|Least Squares Mean
2681072|NCT01396083|Primary|Mean Average BCVA Change From Month 1 Through Month 6 to Baseline|the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6. BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is pproximately 20/20. An increased score indicates improvement in acuity|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Letters||Standard Deviation|Mean
2681073|NCT01396070|Secondary|Overall Non-Evaluable Response|"Overall Non-Evaluable Response of full patient population~3 subjects were not evaluable."|4 weeks||||Participants|||Count of Participants
2681074|NCT01396070|Secondary|Overall Partial Response Rate|"Overall Partial Response Rate (PR) in this study population.~3 subjects were not evaluable."|2 years||||Participants|||Count of Participants
2681075|NCT01396070|Secondary|Overall Stable Disease Rate|"Overall Stable Disease Rate (SD) in this study population.~3 subjects were not evaluable."|2 years||||Participants|||Count of Participants
2681076|NCT01396070|Primary|Overall Response Rate (ORR)|Overall response rate of brentuximab vedotin in this study population.|2 years|The percentage was calculated by adding Complete response (CR) + Partial Response (PR) = Overall rate. 3 subjects were not evaluable.|||percentage|||Number
2681077|NCT01396057|Secondary|Rate of the Internal Ocular Pressure (IOP)|The proportion of patients with ≥ 10% increase in IOP compared to baseline at any post-baseline visit.|Baseline, month 6|The Safety Set consisted of all patients from the RS who had received at least one application of study treatment and had at least one post-baseline safety assessment. Patients were analyzed according to treatment received. The statement that a patient had no adverse events also constituted a safety assessment|||Participants|||Number
2681078|NCT01396057|Secondary|Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires|The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Observed participants are only described in this analysis|||Units on a scale||Standard Deviation|Mean
2681079|NCT01396057|Secondary|Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires|SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. observed is only described in this analysis.|||Units on a scale||Standard Deviation|Mean
2681080|NCT01396057|Secondary|Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires|The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Score on a scale||Standard Deviation|Mean
2681081|NCT01396057|Secondary|Change Over Time of the Central Retinal Thickness (CRT)|Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||µm||Standard Deviation|Mean
2681082|NCT01396057|Secondary|Change Over Time in BCVA|The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors|baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Letters||95% Confidence Interval|Least Squares Mean
2681083|NCT01396057|Secondary|Time to Achieve a Significant Improvement ≥ 15 Letters|The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Time to event (Days)||95% Confidence Interval|Median
2681123|NCT01395758|Secondary|ORR Among Subjects in the Crossover Period Treated With Erlotinib Plus Tivantinib|Per RECIST v1.1, CR = disappearance of all lesions and PR = at least 30% decrease in the sum of diameters of target lesions. ORR = (CR+PR)/# subjects.|Date of randomization to the date of death from any cause or to the date that the subject discontinues from the study, assessed up to 24 months.||||Participants|||Count of Participants
2681084|NCT01396057|Secondary|Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters After 6 Month Treatment|BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline|Baseline, 6 month|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Participants|||Number
2681085|NCT01396057|Secondary|Mean BCVA Change From Baseline to Endpoints Month 1 to Month 6|The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Letters (EDTRS)||95% Confidence Interval|Least Squares Mean
2681086|NCT01396057|Primary|Mean Average Best Corrected Visual Acuity (BCVA) Change From Month 1 Through Month 6 to Baseline|the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6|Baseline, month 6|The Full Analysis Set (FAS) consisted of all patients from the Randomized Set (RS) who had received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned|||Letters||Standard Deviation|Mean
2681087|NCT01396044|Secondary|Standardized Mortality Ratio||Hospital admission|All patients treated with at least one day of empirical antibiotics.|||observed/expected deaths||95% Confidence Interval|Mean
2681088|NCT01396044|Secondary|Proportion of Patients-days on Which Empirical Antibiotics Were Used|Proportion of patients-days on which empirical antibiotics were used|ICU admission|All patients who received at least one day of empirical antibiotics.|||Number of patient-days|||Number
2681089|NCT01396044|Secondary|Proportion of Successful Prompts|"Prompting group: number of patient-days that prompting led to empirical antibiotics being discontinued or narrowed/number of patient-days prompting occurred~Electronic checklist group: number of patient-days that electronic checklist led to empirical antibiotics being discontinued or narrowed/number of patient-days electronic checklist was completed"|During ICU admission, an average of 5 days (although individual patients may vary)|All patients treated with at least one day of empirical antibiotics.|||proportion of patient-days|||Number
2681090|NCT01396044|Secondary|Ventilator-free Days|Number of days within the first 28 days after ICU admission that a patient does not require mechanical ventilation.|During hospitalization, an average of 2 weeks per patient (although individual patients may vary)|All patients treated with at least one day of empirical antibiotics.|||days||Inter-Quartile Range|Median
2681091|NCT01396044|Secondary|Length of Stay||During hospitalization, an average of 2 weeks per patient (although individual patients may vary)|All patients treated with at least one day of empirical antibiotics.|||days||Inter-Quartile Range|Median
2681092|NCT01396044|Secondary|Hospital Mortality||During hospitalization, an average of 2 weeks per patient (although individual patients may vary)|All patients treated with at least one day of empirican antibiotics during ICU admission|||number of deaths|||Number
2681093|NCT01396044|Primary|Proportion of Empiric Antibiotics|The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics).|ICU admission|All patients who received at least one day of empirical antibiotics during their ICU admission.|||proportion of antibiotic-days||Standard Deviation|Mean
2681094|NCT01396044|Primary|Empiric Antibiotic Duration||During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)|All patients who received at least one day of empirical antibiotics during their ICU admission.|||days||Inter-Quartile Range|Median
2681095|NCT01396005|Secondary|Cmax of Naloxone (Administered in Combination With Buprenorphine) at Steady State With or Without Boceprevir|Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.|Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants on Day 1; 1 participant discontinued on Day 6.|||(pg/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
2681096|NCT01396005|Secondary|AUC of Naloxone (Administered in Combination With Buprenorphine) at Steady State With or Without Boceprevir|AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.|Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants on Day 1; 2 participants were discontinued from study (Days 2-8).|||(pg.hr/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
2681148|NCT01395043|Primary|Postoperative Pain Using Numerical Rating Scale (NRS) 0-10|"NRS is a pain score and the score can vary between 0 and 10 by which 0 means no pain and 10 equals the worst possible pain.~NRS was evaluated at the time 0, 1, 2, 4, 8 , 12, 18 , 24 and 36 hours after arriving in the post anesthesia care unit at rest and during coughing."|0-36 hours postoperative||||Units on Numerical Rating Score||Inter-Quartile Range|Median
2681097|NCT01396005|Primary|Cmax of Buprenorphine (Administered in Combination With Naloxone) at Steady State With or Without Boceprevir|Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.|Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants on Day 1; 1 participant discontinued from study on Day 6.|||(pg/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
2681098|NCT01396005|Primary|AUC of Buprenorphine (Administered in Combination With Naloxone) at Steady State With or Without Boceprevir|AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for buprenorphine/naloxone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for buprenorphine/naloxone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for buprenorphine/naloxone + boceprevir.|Buprenorphine/naloxone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and buprenorphine/naloxone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants on Day 1; 2 participants were discontinued from study (Days 2-8).|||(pg.hr/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
2681099|NCT01396005|Primary|Maximum Concentration (Cmax) at Steady State of Methadone Enantiomers When Administered With or Without Boceprevir|Cmax is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for methadone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for methadone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for methadone + boceprevir.|Methadone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and methadone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants receiving standard methadone maintenance therapy + boceprevir|||(ng/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
2681100|NCT01396005|Primary|Area Under the Concentration Versus Time Curve (AUC) at Steady State of Methadone Enantiomers When Administered With or Without Boceprevir|AUC is a measure of the amount of drug in the blood over time, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). The Day 1, 0 through 24 hour samples were for methadone levels in the absence of boceprevir co-administration. The Day 7, 0 through 24 hour samples were for methadone levels in the presence of boceprevir co-administration. The Day 5 and 6 predose samples were to check steady state for methadone + boceprevir.|Methadone samples collected Day 1, 0 (predose) through 24 hours post-dose (Day 2). Boceprevir and methadone samples collected Day 7, 0 (predose) through 24 hours post-dose (Day 8). Predose samples also collected on Days 5-6.|All participants receiving standard methadone maintenance therapy + boceprevir|||(ng.hr/mL)/mg||Geometric Coefficient of Variation|Geometric Mean
2681101|NCT01395966|Primary|Time to Cessation of Otorrhea||From baseline until the end of the study ( up to 22 days)||||days||95% Confidence Interval|Median
2681102|NCT01395914|Secondary|Change in A/CS Domain Score|"Change in the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) 12-item Additional Concerns Subscale (A/CS) domain score is a 12-item scale. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).~The 12-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the A/CS domain ranges from 0 (worst) to 48 (best)."|Change in FAACT A/CS Domain Score from baseline of the original trial through Week 12 of this extension trial||||scores on a scale||Standard Error|Least Squares Mean
2681103|NCT01395914|Secondary|Change in Handgrip Strength of the Non-Dominant Hand||Change in HGS from baseline of the original trial through Week 12 of this extension trial.|Intent-to-Treat Population|||kg||Standard Error|Least Squares Mean
2681104|NCT01395914|Secondary|Change in Body Weight||Change in body weight from baseline of the original trial through Week 12 of this extension trial.|Intent-to-Treat Population|||kg||Standard Error|Least Squares Mean
2681105|NCT01395914|Primary|Percentage of Participants With Treatment-emergent Adverse Events|To Evaluate the Safety and Tolerability of Anamorelin HCl.|Over the 12-week treatment period|Safety Population, defined as patients who received any extension trial study drug.|||percentage of participants|||Number
2681106|NCT01395901|Secondary|Proportion of Patients Without Nausea (Patient Aged > 6 Years)||0-24 hours after T0|The Full Analysis Set (FAS) population aged ≥ 6 years|||percentage of patients||95% Confidence Interval|Number
2681107|NCT01395901|Secondary|Proportion of Patients Without Antiemetic Rescue Medication|Rescue medications are any medications with potential antiemetic effect taken in the 24 hours after patient wake-up from anaesthesia (T0).Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.|0-24 hours after T0|The Full Analysis Set (FAS) population.|||percentage of patients||95% Confidence Interval|Number
2681108|NCT01395901|Secondary|Proportion of Patients Without Emetic Episodes|An emetic episode was defined as one or more continuous vomits (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.|0-24 hours after T0|The Full Analysis Set (FAS) population.|||percentage of patients||95% Confidence Interval|Number
2681109|NCT01395901|Secondary|Proportion of Patients With no Vomiting|Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.|0-24 hours after T0|The Full Analysis Set (FAS) population.|||percentage of patients||95% Confidence Interval|Number
2682734|NCT01381679|Secondary|Change From Baseline in LDL-C at Month 12||Baseline and Month 12|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C.|||mg/dL||95% Confidence Interval|Mean
2681110|NCT01395901|Primary|Proportion of Patients With Complete Response|Complete Response was defined as no vomiting, no retching, and no use of antiemetic rescue medication during the first 24 hours postoperatively, starting at T0. Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.|0-24 hours after T0|The Full Analysis Set (FAS) included all randomized patients who received the active study drug, general anesthesia and surgery (evaluable patients). Following the intent-to-treat principle, patients were assigned to the study treatment arm according to their randomized treatment.|||percentage of patients||95% Confidence Interval|Number
2681111|NCT01395888|Primary|Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 12-week Treatment Period (Day 84)|PWV is defined as the speed of travel of the pressure pulse along an arterial segment and can be obtained for any arterial segment accessible to palpation. aPWV is measured with tonometers positioned transcutaneously at the base of the common carotid artery and over the femoral artery. PWV increases with arterial stiffness and is defined by the Moens-Korteweg equation: PWV=square root of Eh/2pR, where E is Young's modulus of the arterial wall, h is the wall thickness, R is the arterial radius at the end of diastole, and p is the blood density. Change from Baseline was calculated as the Day 84 value minus the Baseline value. The analysis was performed using a repeated measures model with covariates of treatment, visit, age, gender, smoking status at screening, geographical region, Baseline aPWV, and interaction terms of Baseline by visit and treatment by visit.|Baseline to Day 84 (Early Withdrawal)|Intent-to-Treat (ITT) Population: all participants (par.) who were randomized to and received >=1 dose of randomized medication in the TP. The analysis model included all par. in the ITT Population without missing covariate information (MCI) and with >=1 post-BL measurement. Par. presented represent those with data available at Day 84 without MCI.|||meters per second (m/sec)||Standard Error|Least Squares Mean
2681112|NCT01395823|Primary|EPO Dose|The primary outcome is the change in the median EPO dose from baseline to 6 months after ergocalciferol supplementation.|Baseline, 6 months||||units/week||Inter-Quartile Range|Median
2681113|NCT01395810|Secondary|Incidence of Serious Adverse Events (SAEs)|AEs were summarized by frequency of events and frequency of patients with any event. Incidence of serious AEs was expressed as number of serious AEs per subject years of exposure (total number of events /total time in trial).|From Day 1 up to 2 years|Safety Analysis set consisted of all subjects exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns.|||Events per subject year of exposure|||Number
2681114|NCT01395810|Secondary|Incidence of Adverse Events (AEs)|AEs were summarized by frequency of events and frequency of patients with any event. Incidence of AEs was expressed as number of AEs per subject years of exposure (total number of events /total time in trial).|From Day 1 up to 2 years|Safety Analysis Set consisted of all subjects who were exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns.|||Events per subject year of exposure|||Number
2681115|NCT01395810|Secondary|FIX Trough Levels|During the trial, the pre-dose FIX levels was measured with the one-stage clotting assay. Measurements taken at least 5 days and no more than 10 days after last dose as well as at least 14 days after last bleeding episode were included in this analysis. The mean FIX trough levels were estimated based on the mixed effects model on the log-transformed plasma concentration with subject as a random effect. The mean FIX trough level was presented back-transformed to the natural scale.|From Day 1 up to 2 years|Full analysis set consisted of all subjects exposed to nonacog beta pegol. This endpoint was analysed only for the prophylaxis arms (i.e.,10 IU/kg, 40 IU/kg). No pre-dose measurements were collected for patients on 80 IU/kg every second week prophylaxis.|||IU/mL||95% Confidence Interval|Mean
2681116|NCT01395810|Secondary|Number of Bleeding Episodes During Routine Prophylaxis|Annualized bleeding rate is the total number of bleeding episodes/total exposure time. It is analysed by a Poisson regression model with dose as a factor allowing for over-dispersion and using treatment duration as an offset. Median annualized bleeding rate is the median of individual annualized bleeding rates. Numbers are based on the treatment arm at the time of each bleed.|From Day 1 up to 2 years|Full analysis set consisted of all subjects exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns.|||bleeds/patient/year||Inter-Quartile Range|Median
2681117|NCT01395810|Secondary|Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate, Poor)|"The haemostatic effect was evaluated by a four-point scale where an excellent or good outcome translated into a successful treatment, and a moderate or poor outcome was considered a treatment failure. The values mentioned below do not include bleeds with missing response."|From Day 1 up to 2 years|Full analysis set consisted of all subjects exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns.|||Percentage of bleeding episodes|Bleeding episodes||Number
2681118|NCT01395810|Primary|Incidence of Inhibitory Antibodies Against FIX Defined as Titre Above or Equal to 0.6 BU (Bethesda Units)|"The primary endpoint was incidence of inhibitors against coagulation factor nine (FIX) defined as titre~≥0.6 Bethesda unit (BU). Number of subjects who developed inhibitors against FIX are reported."|From Day 1 up to 2 years|Safety Analysis Set consisted of all subjects exposed to nonacog beta pegol. Subjects who switched arms were represented in multiple columns.|||Patients with inhibitory antibodies|||Number
2681119|NCT01395797|Secondary|Measures of Subjective Drug Effects Most Commonly Indicative of Abuse Liability.|"Visual analog scale ratings of Liking reported by the participant will be the primary endpoint (0-100 mm, 0=Not at all, 100=Extremely)."|Following 2 weeks of Pioglitazone (PIO) maintenance.||||units on a scale||Standard Error|Mean
2681120|NCT01395797|Primary|Drug's Break Point|Number of operant responses (mouse clicks) participants were willing to provide in order to receive the drug under investigation (heroin or nicotine). The Breakpoint is the point at which participants stopped responding for the drug, i.e., the total number of clicks they were willing to provide in order to receive the drug.|Following 2 weeks of Pioglitazone (PIO) maintenance.||||Mouse clicks||Standard Deviation|Mean
2681121|NCT01395784|Secondary|Analgesic Responses Using the Cold Pressor Test|Latency to withdraw hand from cold water during the cold pressor test.|Measured during the lab session conducted at the end of each maintenance period||||seconds||Standard Deviation|Mean
2682735|NCT01381679|Secondary|Change From Baseline in LDL-C at Month 3||Baseline and Month 3|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for LDL-C.|||mg/dL||95% Confidence Interval|Mean
2681124|NCT01395758|Secondary|Objective Response Rate (ORR) Among All Eligible Subjects (ITT Population) Treated With Erlotinib Plus Tivantinib Compared to Chemotherapy.|Per RECIST v1.1, Complete Response (CR) = disappearance of all lesions and Partial Response (PR) = at least 30% decrease in the sum of diameters of target lesions. ORR = (CR+PR)/# subjects.|Date of randomization to the date of death from any cause or to the date that the subject discontinues from the study, assessed up to 24 months||||Participants|||Count of Participants
2681125|NCT01395758|Secondary|Overall Survival (OS) Among All Eligible Subjects (ITT Population) Treated With Erlotinib Plus Tivantinib Compared to Chemotherapy.|OS is calculated from the date of randomization until death from any cause.|Date of randomization to the date of death from any cause, assessed up to 24 months||||months||95% Confidence Interval|Median
2681126|NCT01395758|Primary|Progression-free Survival (PFS) Among Subjects With KRAS Mutation Positive NSCLC (ITT Population) Treated With Erlotinib Plus Tivantinib Compared to Single Agent Chemotherapy.|Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) criteria as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or progression of existing non-target lesions are also considered progression.|Date of randomization until disease progression per RECIST (v 1.1) or death from any cause, whichever came first, assessed up to 24 months.||||weeks||95% Confidence Interval|Median
2681127|NCT01395537|Secondary|To Determine the Overall Survival|Overall survival is defined as the length of time between the date of starting treatment and death due to any cause. For a patient who is alive at the time of the statistical analysis, the patient will be considered censored at the last date of known contact.|after 37 months|Participants that received treatment|||weeks||Full Range|Median
2681128|NCT01395537|Primary|PHASE II: To Assess the Response Rate to This Regimen.|Number of patients with stable or responding disease after 6 cycles of carboplatin and paclitaxel will continue treatment with lapatinib alone until progression of disease or intolerable side effects.|after 37 months|Participants eligible to move to phase II of study. Study was cancelled prior to additional participants moving to study.|||Participants|||Count of Participants
2681129|NCT01395537|Primary|PHASE I: Number of Patients That Experience a Grade 3-4 Dose Limiting Toxicity|A dose limiting toxicity (DLT) will be defined as any grade 3-4 non-hematologic toxicity or increase in bilirubin >/= 2 mg/dL (>2X baseline in patients with Gilbert's syndrome), or elevation in AST/ALT > 3.0 X ULN during the first 3 week course of therapy.|after 9 weeks (3 cycles) of treatment|All participants that received treatment|||Participants|||Count of Participants
2681130|NCT01395524|Primary|Incidence of Patients Experiencing Severe Adverse Events (SAEs)|The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period (Week 14)|The Safety analysis set included all patients who participated in Study D3820C00004 and received at least 1 dose of study drug in Study D3820C00007, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Participants|||Number
2681131|NCT01395524|Primary|Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)|The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period (Week 14)|The Safety analysis set included all patients who participated in Study D3820C00004 and received at least 1 dose of study drug in Study D3820C00007, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Participants|||Number
2681132|NCT01395524|Secondary|Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL)|The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.|Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)|The modified intent-to-treat (ITT) analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers.The N denotes the number of patients with a baseline and last on-treatment value.|||units on a scale||Standard Deviation|Mean
2681133|NCT01395524|Secondary|Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)|The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.|Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)|The modified intent-to-treat(ITT) analysis set included all randomized patients, with the exception of patients who were found to have randomized multiple times within the program at different centers. The N denotes the number of patients with a baseline and last on-treatment value.|||units on a scale||Standard Deviation|Mean
2681134|NCT01395524|Primary|Incidence of Patients Experiencing at Least One Adverse Event (AE)|The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period (Week 14)|The Safety analysis set included all patients who participated in Study D3820C00004 and received at least 1 dose of study drug in Study D3820C00007, with the exception of patients who were found to have randomized multiple times within the program at different centers.|||Participants|||Number
2682736|NCT01381679|Secondary|Change From Baseline in TC at Month 12||Baseline and Month 12|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC.|||mg/dL||95% Confidence Interval|Mean
2681135|NCT01395394|Primary|C-Reactive Protein (CRP)|Markers will be assessed every other hour for each 6-hour study visit. Kuvan responders and healthy controls will only be assessed at one 6-hour study visit. Kuvan non-responders will be assessed at two study visits (a baseline visit, and a visit after two weeks of Kuvan therapy). Values will be assessed groupwise and also assessed for intrapersonal change in the Kuvan non-responsive group. Time frame of participation is estimated at one month.|CRP will be measured every other hour for six hours at baseline (study visit 1) for all study groups and again during a second visit 2 weeks after baseline in BH4 Non-Responders only (study visit 2)|Study was terminated due to difficulty recruiting patients, thus analysis was limited to preliminary data on 11 patients only. CRP was measured in 10 subjects - data were unavailable for 1 control participant due to inadequate sample volume.|||mg/dl||Standard Deviation|Mean
2681136|NCT01395394|Primary|Lipid Peroxidation|Markers will be assessed every other hour for each 6-hour study visit. Kuvan responders and healthy controls will only be assessed at one 6-hour study visit. Kuvan non-responders will be assessed at two study visits (a baseline visit, and a visit after two weeks of Kuvan therapy). Values will be assessed groupwise and also assessed for intrapersonal change in the Kuvan non-responsive group. Time frame of participation is estimated at one month.|Lipid peroxidation will be measured every other hour for six hours at baseline (study visit 1) for all study groups|Study was terminated due to difficulty recruiting patients, thus analysis was limited to preliminary data on 11 patients only. TBARS was measured in 3 BH4 responders only - data were unavailable for 8 other participants (2 responders, 3 non-responders, and 3 controls) due to inadequate sample volume.|||umole/L||Standard Deviation|Mean
2681137|NCT01395368|Primary|Brain Speed Test|Standardized Z-scores of the Brain Speed Test (BST-Z scores) calculated based on age group-matched normal population data were used for analysis in order to control for the impact of age on test scores. Age-standardized Z-scores, which reflect the distance from the mean in standard deviation values, allow for the comparison of scores across age groups. A z-score of 0 indicates a value of the average, while absolute z-score values above 2 indicate observations significantly different from normal populations.|Participants completed brain speed test on the same day as enrollment. No follow-up required.|Number of participants who completed the study with the exception of 4 subjects whose data was excluded due to the fact that they were younger than the the normative age-specific data available and BST Z-scores were not able to be calculated.|||z-score||95% Confidence Interval|Mean
2681138|NCT01395329|Primary|FBF Response to ACh in the Absence or Presence of Nonselective Endothelin A/B Blockade (BQ-123+BQ-788)|FBF was measured via strain-gauge occlusion plethysmography at rest and in response to BQ-123+BQ-788 +ACh (4.0, 8.0 and 16.0 ug/100 mL tissue/min) for 5 minutes at each dose. Flows during the last minute of rest and each drug dose were measured and the mean value reported.|Forearm blood flow was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.||||mL/100 mL tissue/min||Standard Error|Mean
2681139|NCT01395329|Primary|FBF Response to Sodium Nitroprusside|FBF was measured via strain-gauge occlusion plethysmography at rest and in response to sodium nitroprusside (1.0, 2.0 and 4.0 ug/100 mL tissue/min) for 5 minutes at each dose. Flows during the last minute of rest and each drug dose were measured and the mean value reported.|Forearm blood flow was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.||||mL/100 mL tissue/min||Standard Error|Mean
2681140|NCT01395329|Primary|FBF Response to Acetylcholine (ACh)|FBF was measured via strain-gauge occlusion plethysmography at rest and in response to ACh (4.0, 8.0 and 16.0 ug/100 mL tissue/min) for 5 minutes at each dose. Flows during the last minute of rest and each drug dose were measured and the mean value reported.|Forearm blood flow was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.||||mL/100 mL tissue/min||Standard Error|Mean
2681141|NCT01395329|Primary|Percent Change in FBF Response to BQ-123 (100 Nmol/Min) + BQ-788 (50 Nmol/Min)|Forearm blood flow (FBF) was measured via strain-gauge venous occlusion plethysmography at rest and every 10 minutes thereafter for 60 minutes. The average percent change for before and after either drug or placebo was calculated as the FBF at (each time point-resting value)/resting value and multiplied by 100 to calculate the percent change. The baseline or resting value was measured before the start of each drug infusion.|Forearm blood flow was measured 0-120 minutes before the 12 week drug or placebo intervention and 0-120 minutes after the 12 week drug or placebo intervention.||||Percent change from baseline||Standard Error|Mean
2681142|NCT01395329|Primary|Percent Change in Forearm Blood Flow (FBF) Response to BQ-123 (100 Nmol/Min)|Forearm blood flow (FBF) was measured via strain-gauge venous occlusion plethysmography at rest and every 10 minutes thereafter for 60 minutes. The average percent change for before and after either drug or placebo was calculated as the FBF at (each time point-resting value)/resting value and multiplied by 100 to calculate the percent change. The baseline or resting value was measured before the start of each drug infusion.|Forearm blood flow was measured at 0-60 minutes before the 12 week drug or placebo intervention and 0-60 minutes after the 12 week drug or placebo intervention.||||percent change from baseline||Standard Error|Mean
2681143|NCT01395329|Primary|Diastolic Blood Pressure||Diastolic blood pressure was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.||||mmHg||Standard Error|Mean
2681144|NCT01395329|Primary|Systolic Blood Pressure||Systolic blood pressure was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.||||mmHg||Standard Error|Mean
2681145|NCT01395316|Primary|Diffusion and Myelin Fraction Water Changes on Magnetic Resonance Imaging (MRI)|"Changes in normal appearing white matter from baseline through month 24.~The MRI is designed to identify possible mechanisms by which alemtuzumab acts to protect the brain from inflammation and how it may enhance repair through remyelination."|Baseline to Month 24||||percent Change||Standard Deviation|Mean
2681146|NCT01395277|Secondary|Pulse Wave Velocity / Arterial Stiffness|Assessment of pulse wave velocity in the common carotid artery and the femoral artery provides an index of arterial stiffness.|Prior to (baseline) and 2 hours following beverage consumption||||cm / sec||Standard Deviation|Mean
2681147|NCT01395277|Primary|Cutaneous Blood Flow Response to Local Heating of the Skin.|Local heating of the cutaneous vasculature to 42 degree C is commonly used to evoke a maximal skin blood flow response (only at the site of local heating). This response is almost entirely dependent on nitric oxide mediated vasodilation.|prior to (baseline) and 2 hours post beverage consumption||||percent change in mean skin blood flow||Standard Deviation|Mean
2681149|NCT01395043|Secondary|Opioid Requirements Postoperative|Supplementary opioid requirements for the first 48 hours from arriving in the post anesthesia care unit. Results are total opioid-requirements for the first 48 hours. Way of administration was intravenous in all but 6 administrations. If given orally, a 1:3 ratio was used for conversion from oral to intravenous morphine.|48 hours from arriving in the post anesthesia care unit.||||mg iv morphin equivalent||95% Confidence Interval|Mean
2681150|NCT01395030|Primary|Number of Participants Comprising Two Distinct PET/CT Imaging Phenotypes (High FCH Uptake vs. Low FCH Uptake) Between the Different Tumor Sub-classes|HCC tumors were sub-classified using gene expression arrays into 3 distinct prognostically-relevant molecular sub-classes (S1,S2, S3, where S3 is associated with the most favorable clinical prognosis) based on Hoshida et. al (PMID 19723656). The number of tumors comprising two distinct PET/CT imaging phenotypes (high FCH uptake vs. low FCH uptake) was compared between the different sub-classes.|Up to study completion at an average of 2.5 years|Patients who underwent FCH PET/CT followed by histopathologic confirmation of the tumor|||Participants|||Count of Participants
2681151|NCT01395030|Primary|Clinical Liver Disease Severity Based on Liver Fibrosis (Metavir) Stage|Odds ratios and 95% confidence intervals for histologic liver fibrosis (Metavir) stage >= F1, >= F2, >= F3, and F4 at liver standardized uptake value (SUV) thresholds of 8.3, 8.0, 7.4, and 6.4, respectively. Reference: PMID 29315063.|Up to 1 year|Number of subjects with available peri-tumoral liver histopathology data|||odds ratio||95% Confidence Interval|Number
2681152|NCT01395030|Primary|Statistical Significance of Molecular Pathways Associated With Choline Metabolism as Identified Through Gene Set Enrichment Analysis of Hepatocellular Carcinoma (HCC) Tumor Samples.|Statistically significant enrichment by sets of genes corresponding to previously-defined molecular pathway signatures was assessed by gene set enrichment analysis (a publicly available algorithm) of whole-genome expression array data obtained from tumors previously characterized by FCH PET/CT. Statistical significance was based on a false discovery rate < 0.05. Tumors demonstrating high choline metabolism (defined by a tumor-liver ratio > 1.0 measured on PET) were assessed for enrichment by publicly-available gene sets. This particular analysis involved the entire Molecular Hallmarks gene signature collection (v6.0) as obtained from the Broad Institute Molecular Signature Database (MSigDB).|Up to study completion at an average of 2.5 years|Patients with histopathologically confirmed HCC who completed FCH PET/CT followed by completion of whole-genome expression array analysis of tumor and adjacent liver tissue obtained following partial hepatectomy.|||false discovery rate|||Number
2681153|NCT01395030|Primary|Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Sensitivity/Specificity|Sensitivity and specificity estimated at a predefined point (ie. Youden's maxima) on the receiver operating characteristic curve for detecting hepatocellular carcinoma with prognostically favorable molecular features (Hoshida molecular sub-class S3) based on FCH PET/CT measurement of tumor maximum standardized uptake value (SUVmax) in patients who underwent subsequent tumor resection.|Up to study completion at an average of 2.5 years|Patients from whom surgical tumor resection (ie. partial hepatectomy) provided adequate tumor and liver samples for tissue analysis.|||percentage of analyzed participants|||Number
2681154|NCT01395030|Primary|Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Area Under the Receiver Operating Characteristic Curve.|Area under the receiver operating characteristic curve for detecting resectable hepatocellular carcinoma with prognostically favorable molecular features (Hoshida molecular sub-class S3) based on FCH PET/CT measurement of tumor maximum standardized uptake value (SUVmax).|Up to study completion at an average of 2.5 years|Patients from whom surgical tumor resection (ie. partial hepatectomy) provided adequate tumor and liver samples for tissue analysis.|||unitless|||Number
2681155|NCT01395017|Secondary|Progression Free Survival (PFS)|PFS - time from randomization to unequivocal local or distant disease progression, death or discontinuation from trial for any reason by 02 December 2013. Progression events were determined according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 every 8 weeks.|Time from randomization to earliest PFS event by 02 December 2013|The ITT data which was composed of all randomized participants.|||Days||95% Confidence Interval|Median
2681156|NCT01395017|Primary|Overall Survival|Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013.|From randomization until date of death from any cause by 02 December 2013|The intent-to-treat (ITT) data which was composed of all randomized participants.|||Days||95% Confidence Interval|Median
2681157|NCT01394991|Secondary|Red Blood Cell Transfusions|The number of participants who received at least 1 red blood cell (RBC) transfusion (packed RBC or whole blood) during the study.|during the study (randomization through week 26)|All participants who were randomized, regardless of whether or not they received study drug.|||participants|||Number
2681158|NCT01394991|Secondary|Number of Hemoglobin Responders|Hemoglobin response was defined as a hemoglobin increase of ≥2 g/dL from baseline or reaching a hemoglobin concentration of 12 g/dL, regardless of dose adjustment.|during the study (randomization through week 26)|All participants who were randomized, regardless of whether or not they received study drug.|||participants|||Number
2681159|NCT01394991|Secondary|Mortality|Number of participants who died during the study.|during the study (randomization through week 26)|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2681160|NCT01394991|Secondary|Time to First Suspected Thrombovascular Event|Analysis of time to first suspected thrombovascular event (TVE) measured from the date of randomization to the date of the first suspected TVE during the study. Median time is non-estimable because of too few events, incidence was reported instead.|during the study (randomization through week 26)|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2681161|NCT01394991|Secondary|Number of Suspected Thrombovascular Events|Number of participants who have at least 1 suspected thrombovascular events (TVEs) during the entire study. Suspected TVEs were defined as suspected TVEs during the entire study, whether clinically relevant and objectively confirmed by the Adjudication Committee or not, whether confirmed by the investigator or not.|during the study (randomization through week 26)|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2681242|NCT01393899|Secondary|Change From Baseline in Fecal Calprotectin by Week|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.|Weeks 8, 12 and 26|mFAS|||milligrams per kilogram (mg/kg)||Standard Deviation|Mean
2681162|NCT01394991|Secondary|Time to First Positively Adjudicated Thrombovascular Event|Analysis of time to first positively adjudicated thrombovascular event (TVE) measured from the date of randomization to the date of the first clinically relevant and objectively confirmed TVE as determined by the Adjudication Committee. Median time is non-estimable because of too few events, incidence was reported instead.|during the study (randomization through week 26)|All randomized participants who received at least 1 dose of study drug.|||participants|||Number
2681163|NCT01394991|Secondary|Number of Positively Adjudicated Thrombovascular Events|The number of participants who have at least 1 clinically relevant and objectively confirmed (adjudicated) thrombovascular event (TVE) during the study.|during the study (randomization through week 26)|The modified intent-to-treat (mITT) population used for safety analysis population included all randomized participants who received at least 1 dose of study drug.|||participants|||Number
2681164|NCT01394991|Primary|Number of Participants With at Least 1 Clinically Relevant and Objectively Confirmed Thrombovascular Event From Randomization Through Week 16|Clinically relevant and objectively confirmed thrombovascular event (TVE) was determined by the Adjudication Committee from randomization through Week 16. Clinically relevant TVEs were defined as deep vein thrombosis (DVT) of the limbs; thromboses of other major veins; pulmonary embolism (PE);acute coronary syndrome (ACS);ischemic stroke of arterial or cardiac origin; cerebral venous thrombosis; and arterial thrombosis. Objectively confirmed was defined as the confirmation of the clinical diagnosis of a TVE by appropriate medical imaging studies and laboratory tests.|from randomization through Week 16|The modified intent-to-treat (mITT) population was defined to include all randomized participants who received at least 1 dose of study drug.|||particpants|||Number
2681165|NCT01394978|Primary|Safety Endpoints|"Pulmonary adverse events: pneumothorax, persistent air leak, late onset air leak, residual pleural space, and acute respiratory distress syndrome~Renal adverse events~Cardiac adverse events~Death (all causes)~Hospital readmission"|90 days|Units analyzed represents the number of adverse events that occurred among all study participants in each arm.|||Events|Events||Count of Units
2681166|NCT01394952|Secondary|Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of First Hospitalization for Unstable Angina|Time to first occurrence after randomization of first hospitalization for unstable angina was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.|From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)|All randomized participants.|||Participants|||Count of Participants
2681167|NCT01394952|Secondary|Number of Participants Who Experienced An Event for Time to First Occurrence After Randomization of Heart Failure Requiring Hospitalization or an Urgent Heart Failure Clinic Visit|The time to first occurrence after randomization of heart failure requiring hospitalization or an urgent heart failure clinic visit was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.|From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)|All randomized participants.|||Participants|||Count of Participants
2681168|NCT01394952|Secondary|Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint|The time from randomization to first occurrence of the composite microvascular endpoint was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The composite microvascular endpoint is defined as diabetic retinopathy requiring laser therapy, vitrectomy, or anti-vascular endothelial growth factor therapy (VEGF), clinical proteinuria, a greater than equal ≥ 30% decline in estimated glomerular filtration rate, or need for chronic renal replacement therapy. The number of participants who experienced the composite microvascular endpoint event is presented.|From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)|All randomized participants.|||Participants|||Count of Participants
2681169|NCT01394952|Secondary|Number of Participants Who Experienced an Event for Time to All-cause Mortality|The time to all-cause mortality was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.|From randomization to study completion (Median Follow-Up of 5.4 Years)|All randomized participants.|||Participants|||Count of Participants
2681170|NCT01394952|Secondary|Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually|The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (individually) was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. Death from CV causes is defined as a death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, or death due to other CV causes. The number of participants who experienced an event is presented.|From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)|All randomized participants.|||Participants|||Count of Participants
2681171|NCT01394952|Primary|Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)|The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite endpoint) was evaluated using time-to-event analysis. The primary analysis model was a Cox proportional hazards regression model for the time to the first occurrence of a primary endpoint event, with treatment as a fixed effect using the intent-to-treat population. The number of participants who experienced a primary cardiovascular (CV) endpoint event is presented.|From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years)|All randomized participants.|||Participants|||Count of Participants
2681172|NCT01394926|Secondary|Detecting the Presence of Greater Than or Equal to 50% Stenosis and Greater Than or Equal to 75% Stenosis in the Carotid Arteries When Comparing Pre-contrast to Post-contrast Ultrasound by Dose Group.|Detecting the presence of greater than or equal to 50% stenosis and greater than or equal to 75% stenosis in the carotid arteries when comparing pre contrast to post-contrast U/S by dose group.Using the 3 different dose levels of 0.15 mL, 0.5 mL and 1.5 mL of Optison.|Up to 10 minutes post contrast administration.|Due to difficulty enrolling subjects in all three dose levels of Optison , this study was stopped prematurely. No efficacy analyses were performed.||||||
2681173|NCT01394926|Primary|Finding the Optimal Dose of Optison From 3 Different Dose Levels; 0.15mL, 0.5mL, and 1.5mL.|Assessing the presence of disease of the carotid arteries when comparing pre-contrast to post-contrast ultrasound (U/S) by dose group. Using the optimal dose from 3 different dose levels - 0.15 mL, 0.5 mL and 1.5 mL of Optison.|Up to 10 minutes post contrast administration.|Due to difficulty enrolling subjects in all three dose levels of Optison, this study was stopped prematurely. No efficacy analyses were performed.||||||
2681174|NCT01394718|Secondary|Average Pruritus Score|Pruritus scores were recorded by the nursing staff approximately 4 times over the first 24 hours and then averaged for the 24 hour period. Pruritus scores range from 1 (none) to 3 (intolerable).|24 hours|Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo|||units on a scale||Full Range|Median
2681175|NCT01394718|Secondary|Average Nausea Score|Nausea scores were recorded by the nursing staff approximately 4 times over the first 24 hours and then averaged for the 24 hour period. Nausea Scores range from 1 (none) to 4 (severe).|24 hours|Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo|||units on a scale||Full Range|Median
2681176|NCT01394718|Secondary|Average Pain Score|Pain Scores were monitored using the numeric pain assessment scale in both treatment arms of the study and recorded and averaged for the first 24 hours after initial intra-operative dose of study drug. The numeric pain assessment scale is a verbal self-reported pain assessment that ranges between 1 (no pain) to 10 (worst pain imaginable).|24 hours|Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo|||units on a scale||Standard Deviation|Mean
2681177|NCT01394718|Primary|Total Opiate Requirement|Total opiate requirement was monitored 24 hours post-operatively. Morphine and hydromorphone measurements were totaled and recorded in mg/kg/day of morphine equivalents.|24 hours|Subjects were deemed evaluable if a minimum of 24 hours of data was collected post-operatively, with receipt of at least four doses of study drug, prior to study withdrawal or unblinding, with T0 (time zero) being time of administration of first dose of either treatment drug or placebo.|||mg/kg||Standard Deviation|Mean
2681178|NCT01394705|Secondary|Body Mass Index|Secondary hypotheses include greater improvement in body mass index (BMI) reported below.|Baseline, 3 months||||BMI (kg/m2)||Full Range|Median
2681179|NCT01394705|Primary|Physical Activity|Total time (minutes) in Physical Activity in one week|Baseline, 3 months||||minutes per week||Full Range|Median
2681180|NCT01394692|Secondary|Neurological Deficit|Assessment of new postoperative deficits following tumor surgery|7 days|||||||
2681181|NCT01394692|Secondary|Volumetric Assessment|Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI|72 hours|||||||
2681182|NCT01394692|Secondary|Progression-free Survival|Progression-free survival (radiological and/or clinical progression) at 6 months following surgery|6 months|||||||
2681183|NCT01394692|Primary|Extent of Resection|Number of patients with contrast-enhancing glioma in whom a complete excision of the tumor according to postoperative high-field MRI within 72 hours is achieved|72 hours|Patients in whom histological examination of tumor specimens did not result in diagnosis of a glioma were excluded for final analysis.|||participants|||Number
2681184|NCT01394627|Secondary|Change From Baseline in Inflammation|Change in interleukin-6|Baseline and 2 hours after hypoglycemia|We included the 17 subjects who completed each arm and had interleukin-6 data for both arms (placebo and eplerenone). We calculated the change in IL-6 as IL-6 during hypoglycemia minus IL-6 at baseline.|||pg/ml||Standard Deviation|Mean
2681185|NCT01394627|Primary|Change From Baseline in Cardiovascular Autonomic Function|Modified oxford procedures was performed in duplicate immediately prior to start of the hypoglycemic clamp and during the last 30 min of the clamp (i.e. during the last 30 min of exposure to 2 hours of hypoglycemia).. We calculated the baroreflex sensitivity (the relationship between RR interval and change in systolic blood pressure defined as the change in the inter-beat cardiac interval in milliseconds per unit change in blood pressure in mmHg) at each time point and then the change in baroreflex sensitivity (BRS during hypoglycemia minus BRS at baseline)|Baseline and 2 hours after hypoglycemia|We included the 13 subjects who completed each arm, had usable baroreflex sensitivity data for both treatments (placebo and eplerenone), and achieved a blood sugar during hypoglycemia of less than or equal to 3.0 mmol/L for each clamp.|||ms/mmHg||Standard Deviation|Mean
2681186|NCT01394614|Primary|Incidence of Narcolepsy Among Narcoleptic Subjects Exposed or Unexposed to Vaccine|Incidence rates will be computed by comparing narcolepsy incidence rates in exposed and non-exposed subjects. Comparison of narcolepsy incidence rates in the period prior to vaccine administration and pseudo-vaccine administration will be used to test the comparability of exposed and non-exposed group.|Narcolepsy onset during the 16-week post-vaccination period.||||events per 100,000 person-years|||Number
2681187|NCT01394523|Primary|Post-operative Pain Score|Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain.|30 minutes||||pain score||Standard Deviation|Mean
2681188|NCT01394510|Secondary|Oral Disposition Index|The change in the oral disposition index defined was the change in the early insulin response divided by the change in glucose from 0-30 minutes during the oral glucose tolerance test divided by fasting insulin.|4 weeks||||mg/dl||Standard Deviation|Mean
2681189|NCT01394510|Secondary|Area Under the Curve for Glucose (AUCg)|Change in AUCg from 0-120 minutes during the oral glucose tolerance test at 4 weeks compared to baseline|4 weeks||||mg/dl x 120 minutes||Standard Deviation|Mean
2681243|NCT01393899|Secondary|Fecal Calprotectin by Week|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.|Baseline and Weeks 8, 12 and 26|mFAS|||milligrams per kilogram (mg/kg)||Standard Deviation|Mean
2681190|NCT01394510|Primary|Fasting Urine F2 Alpha Isoprostane Levels|Change in fasting urine isoprostane levels at 4 weeks vs baseline as a marker of oxidative stress|4 weeks|Change in urine F2 alpha isoprostanes/mg urine creatinine. Urine isoprostanes were only measured in a subset of participants due to lack of effect of the intervention on glucose tolerance.|||ng/ml||Standard Deviation|Mean
2681191|NCT01394276|Secondary|Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents|The HAQ is a participant-completed questionnaire specific for RA, recommended by the American college of Rheumatology for the evaluation of quality of life. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. There are 4 possible responses for each question: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do. To calculate HAQ, participant must have a component set score for at least 6 of 8 component set. The HAQ is the sum of the scores, divided by the number of component set that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). Data allowing the evaluation of HAQ was available for 73 participants in DMARD-IR group and 157 participants in DMARD + anti-TNF-IR group.|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. The “n” represents the number of participants analyzed at a specified time point.|||units on a scale||Standard Deviation|Mean
2681192|NCT01394276|Secondary|Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents|"VAS for fatigue is a 100 mm scale for participant's assessment of their current level of fatigue: 0 mm corresponds to no perception of fatigue; 100 mm is the maximum that may be perceived. The mean VAS fatigue scores were evaluated after the first infusion of TCZ in two different sub populations, classified according to the previous pharmacological treatment: participants with inadequate response to DMARD (DMARD-IR: group A) or to DMARD and anti-TNF drugs (DMARD + anti-TNF-IR: group B). Data allowing the evaluation of fatigue (VAS) was available for 45 participants in DMARD-IR group and 113 participants in DMARD + anti-TNF-IR group."|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|"The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. The n represents the number of participants analyzed at a specified time point."|||units on a scale||Standard Deviation|Mean
2681193|NCT01394276|Secondary|Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents|The DAS28 index applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints) 3. ESR or CRP measurement, 4. Participant's judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation. The mean DAS28 scores were evaluated after the first infusion of TCZ in two different sub populations: participants with inadequate response (IR) to DMARD (DMARD-IR: group A) or to DMARD and anti-TNF drugs (DMARD + anti-TNF-IR: group B). Data allowing the evaluation of DAS28 was available for 81 participants in DMARD-IR group and 203 participants in DMARD + anti-TNF-IR group.|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|"The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. The n represents the number of participants analyzed at a specified time point."|||units on a scale||Standard Deviation|Mean
2681194|NCT01394276|Secondary|Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand.|The presence and severity of SH and JE of third MCP joint of left hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of third MCP joint of left hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra-articular surface).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.|||participants|||Number
2681195|NCT01394276|Secondary|Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand|The presence and severity of SH and JE of second MCP joint of left hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of second MCP joint of left hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra-articular surface).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.|||participants|||Number
2681196|NCT01394276|Secondary|Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand.|The presence and severity of SH and JE of third MCP joint of right hand was determined by ultrasound examination. According to the method proposed by Naredo, SH and JE were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization of third MCP joint of right hand was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intraarticular surface).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.|||participants|||Number
2688162|NCT01335932|Secondary|CMV AUC in Throat|CMV AUC in Throat from day 0 to day 28|Day 0 to 28 days post-randomization||||IU*day/mL||Standard Deviation|Mean
2681197|NCT01394276|Secondary|Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand.|The presence and severity of synovial hyperplasia (SH) and joint effusion (JE) of second metacarpo-phalangeal (MCP) joint of right hand was determined by ultrasound examination. According to the method proposed by Naredo, synovial hyperplasia and joint effusion were evaluated based on scoring from 1 to 3 (1 = mild, 2 = moderate, 3 = marked). Vascularization was evaluated with power doppler ultrasound and the score was assessed by a semi quantitative scale ranging from 0 to 3 (0 = normal; 1 = slight, evidence of a single flow signal; 2 = moderate, confluent vessels; 3 = marked, evidence of multiple flow signals in over half the intra articular surface).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.|||participants|||Number
2681198|NCT01394276|Secondary|Percentage of Participants Still on Tocilizumab Treatment Till 12 Months After the 1st Infusion|Percentage of participants who continued treatment till 12 months after the first infusion with TCZ was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.|||percentage of participants|||Number
2681199|NCT01394276|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a participant who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.|||participants|||Number
2681200|NCT01394276|Secondary|Percentage of Participants Discontinuing Treatment With Tocilizumab|The percentage of participants who prematurely discontinued treatment with TCZ during the study period was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.|||percentage of participants|||Number
2681201|NCT01394276|Secondary|Number of Participants With Concomitant Medications|Number of participants treated with at least one concomitant medication i.e., corticosteroid (Prednisone, Methyl prednisolone) was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication.|||participants|||Number
2681202|NCT01394276|Secondary|Mean Score of Health Assessment Questionnaire in Participants on Monotherapy With Tocilizumab|The health assessment questionnaire (HAQ) is a participant-completed questionnaire specific for RA, recommended by the American college of Rheumatology for the evaluation of quality of life. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. There are 4 possible responses for each question: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do. To calculate HAQ, the participant must have a component set score for at least 6 of 8 component set. The HAQ is the sum of the scores, divided by the number of component set that have a score (in range 6-8) for a total possible score of minimum/maximum i.e., 0 (best) to 3 (worst).|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of HAQ was available for 66 participants in TCZ group. The “n” represents the number of participants analyzed at a specified time point.|||units on a scale||Standard Deviation|Mean
2681203|NCT01394276|Secondary|Mean Score of Fatigue Based on Visual Analogue Scale in Participants on Monotherapy With Tocilizumab|"VAS for fatigue is a 100 mm scale for participant's assessment of their current level of fatigue. The '0 'mm corresponds to no perception of fatigue, '100 mm' is the maximum level of fatigue that may be perceived. Mean score of VAS fatigue in participants were reported."|Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of fatigue based on VAS was available for 50 participants in TCZ group. The “n” represents the number of participants analyzed at a specified time point.|||units on a scale||Standard Deviation|Mean
2681204|NCT01394276|Secondary|Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab|The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3.ESR or CRP measurement, 4. Participant's judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation.|Baseline (Month 0), Month 1, Month 2, Month 4, Month 6, and Month 12|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of disease activity based on 28 joints count was available for 93 participants in TCZ group.|||units on a scale||Standard Deviation|Mean
2681219|NCT01394003|Secondary|Pharmacokinetics, Area Under the Concentration-Time Curve (AUC) With Twice Daily (BID) LY2584702 Dosing|Results for AUC from time 0 to infinity [AUC(0-inf)] and AUC from time 0 to 12 hours [AUC(0-12)] on Day 1 and Day 8 (steady state) are reported for participants with a BID LY2584702 dosing regimen.|Parts A and B, Cycle 1: Day 1 and Day 8 (predose, 0.5, 1, 2, 3, 5, and 8 hours postdose)|All participants who received at least 1 dose of study drug [BID dosing regimen (Part A or B)] and had evaluable AUC data. In 300 mg LY2584702 BID group data was not analyzed for AUC(0-12) day 8 due to insufficient participants at the specified time point.|||nanograms*hours/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2688163|NCT01335932|Secondary|CMV AUC in Blood|CMV AUC in blood from day 0 to day 28|Day 0 to 28 days post-randomization||||IU*day/mL||Standard Deviation|Mean
2681205|NCT01394276|Primary|Percentage of Participants Achieving Disease Remission After 6 Months of Treatment|Disease remission is defined as a DAS28 score < 2.6. The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3. ESR or CRP measurement, 4. Participant's judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation. Percentage of participants with disease remission was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of disease remission was available for 226 participants in TCZ group.|||percentage of participants|||Number
2681206|NCT01394276|Primary|Percentage of Participants Achieving Low Disease Activity After 6 Months of Treatment|Low disease activity is defined as a disease activity score based on 28 joint count (DAS28) score lesser or equal to (</=) 3.2. The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3. Erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) measurement, 4. Participant's judgement on his own overall health status expressed by a visual analogue scale (VAS). The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. Percentage of participants with low disease activity was reported.|Up to 12 months|The total population included all participants who met all inclusion/exclusion criteria described in the study and received at least one dose of study medication. Data allowing the evaluation of low disease activity was available for 226 participants in TCZ group.|||percentage of participants|||Number
2681207|NCT01394250|Secondary|Comparison of the Face, Legs, Activity, Cry, Consolability Scale (FLACC) Score Immediately After IV Cannulation Between Groups|The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2. The FLACC score was completed immediately after IV cannulation by a member of the clinical care team who was not part of the study. During initial trial design, the goal was to collect FLACC score pre and post cannulation; however, it was decided prior to enrollment that FLACC score would not be collected pre cannulation, only post.|Up to 5 minutes after IV Cannulation|Analysis population includes only subjects whose first intravenous (IV) cannulation attempt was successful.|||units on a scale||95% Confidence Interval|Median
2681208|NCT01394250|Primary|Change From Baseline in Faces Pain Scale Revised (FPS-R) at 30 Minutes After IV Cannulation|"The Faces Pain Scale Revised (FPS-R) is numerical self-report measure of pain intensity developed for children to score the sensation of pain from 0-10. Pictures of 6 cartoon faces ranging from neutral expression of no pain (0) to very much pain (10)."|Baseline and 30 minutes|Analysis population includes only subjects whose first intravenous (IV) cannulation attempt was successful.|||units on a scale||95% Confidence Interval|Mean
2681209|NCT01394211|Secondary|Proportion of Patients Achieving Down-staging to a Pathologic Stage 0 or 1||Six months from the initiation of neoadjuvant therapy|Participants withdrew from participation||||||
2681210|NCT01394211|Secondary|Proportion of Patients Achieving Sustained Decrease in Ki-67||12 weeks from the initiation of neoadjuvant therapy|Participants withdrew from participation||||||
2681211|NCT01394211|Primary|Rate of pCR at Primary Site (T0) and Nodal Sites (T0N0)|Defined as no evidence of microscopic invasive tumor present. Determined by pathology. Estimated with an exact 95% confidence interval.|Six months from the initiation of neoadjuvant therapy|Participants withdrew from participation||||||
2681212|NCT01394185|Primary|Marijuana Self-administration - Drug Vs Money Choice|Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) in 5 discrete choices each day between one cannabis cigarette and $1. The number of cannabis cigarettes chosen (and subsequently self-administered) is the primary study endpoint|12-day Dronabinol maintenance period||||Cannabis Cigarettes Chosen||Standard Error|Mean
2681213|NCT01394185|Primary|Marijuana Self-administration - Progressive Ratio|Participants will be able to self-administer cannabis cigarettes (weighing about 0.8 grams and with about 6% THC) under a progressive ratio schedule. The number of progressive ratios completed (and thus, cannabis cigarettes consumed) is the primary study endpoint|12-day Dronabinol maintenance period||||Progressive Ratios Completed||Standard Error|Mean
2681214|NCT01394159|Secondary|Technical Failure|Malfunction of the needle during endoscopic ultrasound-guided sampling of the pancreatic mass lesion before a diagnosis is achieved|6 months||||participants|||Number
2681215|NCT01394159|Secondary|Diagnosis Achieved With the Needle||6 months||||participants|||Number
2681216|NCT01394159|Primary|Compare the Median Number of Passes Required to Establish a Diagnosis||6 months||||No. of passes for diagnosis||Inter-Quartile Range|Median
2681217|NCT01394081|Secondary|Days Until VA Clinic Appointment|The number of days from day of randomization to day that the participant attended the VA clinic appointment (derived from the VA medical records). Participants who did not attend a VA clinic appointment be the end of 6-month observation period were classified as censored at 6 months.|6 months||||days||Standard Deviation|Mean
2681218|NCT01394081|Primary|Attendance at a VA Appointment|Attendance at a VA appointment was derived from VA clinical records, defined as the participant attending a scheduled VA clinic appointment. Participants who did not attend a VA clinic appointment be the end of 6-month observation period were classified as censored at 6 months.|6 months|Consenting participants who were randomized and lived in rural location.|||participants|||Number
2681244|NCT01393899|Secondary|Change From Baseline in CRP by Week|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Weeks 4, 8, 12, 20 and 26|mFAS|||milligram per liter (mg/L)||Standard Deviation|Mean
2681220|NCT01394003|Secondary|Pharmacokinetics, Area Under the Concentration-Time Curve (AUC) With Once Daily (QD) LY2584702 Dosing|Results for AUC from time 0 to infinity [AUC(0-inf)] and AUC from time 0 to 24 hours [AUC(0-24)] on Day 1 and Day 8 (steady state) are reported for participants on a QD LY2584702 dosing regimen.|Part A, Cycle 1: Day 1 and Day 8 (predose, 0.5, 1, 2, 3, 5, and 8 hours postdose)|All participants who received at least 1 dose of study drug [QD dosing regimen (Part A)].|||nanograms*hours/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2681221|NCT01394003|Secondary|Number of Participants With Tumor Response|Tumor response was defined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.0) criteria. Complete Response (CR) was the disappearance of all target and non-target lesions and normalization of tumor marker levels of non-target lesions; Partial Response (PR) was at least a 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) was at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions; Stable Disease (SD) was small changes that did not meet above criteria including persistence of 1 or more non-target lesion(s).|Parts A and B, Baseline through study completion [up to Cycle 10 (1 cycle=28 days)]|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2681222|NCT01394003|Secondary|Pharmacokinetics, Maximum Plasma Concentration (Cmax)|Cmax results on Day 1 and on Day 8 (steady state) are reported.|Parts A and B, Cycle 1: Day 1 and Day 8 (predose, 0.5, 1, 2, 3, 5, 8 hours postdose)|All participants who received at least 1 dose of study drug and had evaluable Cmax data. In 300 mg LY2584702 BID group data was not analyzed for Cmax day 8 due to insufficient participants at the specified time point.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2681223|NCT01394003|Primary|Recommended Dose for Phase 2 Studies/Maximum Tolerated Dose (MTD)|Based on the maximum tolerated dose (MTD): highest dose where <33% participants experienced a dose-limiting toxicity (DLT). DLTs were adverse events (AEs) during Cycle 1 that met any 1 of the following criteria using National Cancer Institute's (NCI) Common Terminology Criteria for AEs (CTCAE) grading: any ≥Grade 3 nonhematological toxicity (except nausea/vomiting, diarrhea or hypophosphatemia without maximal symptomatic/prophylactic treatment) that was not related to study disease, any ≥Grade 3 thrombocytopenia with bleeding, any Grade 4 hematological toxicity of >5 days duration or any febrile neutropenia. Investigators, together with the sponsor, could declare a DLT during Cycle 1 if a participant experienced increasing toxicity and it was clear that further treatment would expose the participant to excessive risk. The MTD was below the level required for efficacy, therefore, the study was terminated early and the recommended Phase 2 dose was not calculated.|Parts A and B, Baseline through Cycle 1 (1 cycle=28 days)|All participants who received at least 1 dose of study drug.|||milligrams (mg)|||Number
2681224|NCT01393990|Secondary|Pharmacodynamics (PD): Number of Participants With Greater Than 50% Inhibition of p38 Mitogen-Activated Protein Kinase (MAPK) Activity on Day 1|The effect of LY2228820 on PD biomarker was measured as MAPK-activated protein kinase -2 (MAPKAP-K2) level which is regulated by p38 MAPK activity. Inhibition of p38 MAPK activity will result in lower levels of MAPKAPK-2.|Cycle 1 Day 1: predose, 1, 2, 4, and 6 h postdose|All participants who received at least 1 dose of study drug and had evaluable PD data. At the dose confirmation of 300 mg, the pMAPKAP-K2 inhibition reached above 50% on Day 1 as maximum inhibition.|||Participants|||Count of Participants
2681225|NCT01393990|Secondary|PK: Maximum Plasma Concentration (Cmax) of LY2228820||Cycle 1, Days 1 and 14: predose, 0.5, 1, 2, 3, 4, 6 and 8 h postdose|All participants who received at least 1 dose of study treatment and had evaluable PK data. Participants in 300 mg and 420 mg are combined to measure PK outcome; as dose, formulations and population are same.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2681226|NCT01393990|Secondary|PK: Area Under the Concentration-Time Curve From Time Zero to 8 Hours (AUC0-8) of LY2228820||Cycle 1, Days 1 and 14: predose, 0.5, 1, 2, 3, 4, 6 and 8 h postdose|All participants who received at least 1 dose of study drug and had evaluable PK data. Participants in 300 mg and 420 mg are combined to measure PK outcome; as dose, formulations and population are same.|||nanograms*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2681227|NCT01393990|Secondary|Percentage of Participants With Best Overall Response [Complete Response (CR)+Partial Response (PR)+Stable Disease (SD)]|Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level in non-target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions. PD was defined as having at least a 20% increase in the sum of the LD of target lesion and appearance of ≥1 new lesion and/or unequivocal progression of existing nontarget lesions. SD was defined as small changes that did not meet the above criteria taking as reference the smallest sum LD since treatment started.|Baseline to study completion (Up to 41 months)|All participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2681228|NCT01393990|Secondary|Recommended Dose for Phase 2 Studies|Recommended Phase 2 dose was determined by maximum tolerated dose (MTD), which was determined by Dose-limiting toxicity (DLT). For the purpose of this study, the MTD was defined as the highest dose level at which no more than 33% of participants experience a DLT during Cycle 1.|Baseline to study completion (Up to 41 months)|Any participant who received at least 1 dose of study drug.|||milligrams (mg)|||Number
2681229|NCT01393990|Primary|Number of Participants With Clinically Significant Effects (Physical Assessments and Safety Lab Tests)|Data presented are the number of participants who experienced at least one treatment emergent adverse event (TEAE). A TEAE is defined as an event that first occurred or worsened after the administration of at least 1 dose of study drug, regardless of causality. A summary of serious AEs (SAEs) and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline to study completion (Up to 41 months)|Any participant who received at least 1 dose of study drug.|||Participants|||Count of Participants
2681245|NCT01393899|Secondary|C-Reactive Protein (CRP) by Week|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Baseline and Weeks 4, 8, 12, 20 and 26|mFAS|||milligram per liter (mg/L)||Standard Deviation|Mean
2682737|NCT01381679|Secondary|Change From Baseline in Total Cholesterol (TC) at Month 3||Baseline and Month 3|Participants with baseline, follow-up visit 1 (3 months), and follow-up visit 2 (12 months) measurements for TC.|||mg/dL||95% Confidence Interval|Mean
2681230|NCT01393964|Other Pre-specified|Geometric Mean Apparent Volume of Distribution (Vz) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. Vz was measured in mL per kilogram body weight (mL/kg). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.|||mL/kg||Geometric Coefficient of Variation|Geometric Mean
2681231|NCT01393964|Other Pre-specified|Geometric Mean Total Body Clearance (CLT) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. CLT was measured in mL per hour per kilogram body weight (mL/h/kg). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.|||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
2681232|NCT01393964|Other Pre-specified|Median Time to Maximal Concentration (Tmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. Tmax was measured in hours (h). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.|||h||Full Range|Median
2681233|NCT01393964|Other Pre-specified|Mean Terminal-phase Elimination Half-life (T-Half) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. T-Half was measured in hours (h). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.|||h||Standard Deviation|Mean
2681234|NCT01393964|Secondary|Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests|Sodium high (H) Gr 1:>ULN - 150; Gr 2: >150 - 155; Gr 3: >155 - 160; Gr 4: >160 mmol/L; Sodium low(L) Gr 1:<LLN - 130; Gr 3: <130 - 120; Gr 4: <120 mmol/L. Potassium (H) Gr 1: >ULN - 5.5; Gr 2: >5.5 - 6.0; Gr 3: > 6.0 - 7.0; Gr 4: >7.0 mmol/L; Potassium (L) Gr 1: <LLN - 3.0; Gr 2: <LLN - 3.0; Gr 3: < 3.0 - 2.5; Gr 4: <2.5 mmol/L. Bicarbonate Gr1: 16-<LLN, Gr2: 11-16, Gr3, 8-11, Gr4: <8 milliequivalents per liter (mEq/L). Phosphorus Gr 1: 2.5 - <LLN, Gr2 2.0-<2.5, Gr3: 1.0-<2.0, Gr4: <1.0. Calcium (L) Gr 1: <LLN to 8.0; Gr2: 7.0 - 8.0; Gr3: 6.0-7.0; Gr 4: <6.0 mg/dL; calcium (H) Gr1:>ULN - 11.5, Gr2:>11.5 - 12.5, Gr3: 12.5 - 13.5, Gr4: >13.5.|From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)|All participants who received at least one dose of study treatment (at least one dose of any drug) were summarized.|||participants|||Number
2681241|NCT01393899|Secondary|Tofacitinib Plasma Concentration by Nominal Post-Dose Sampling Time and Tofacitinib Dose|Plasma samples were collected from participants for the determination of tofacitinib concentrations. Only samples from tofacitinib-treated participants were subsequently analyzed. Plasma concentration data are summarized by nominal sample collection times specified in the protocol, and actual sample collection times may be different.|Pre-dose, 20 minutes, 40 minutes, 1 hour and 2 hours post-dose at Weeks 12 and 26/early termination visit|Pharmacokinetic analysis set - included all participants who received at least 1 dose of study medication and had at least 1 measurable plasma concentration. n=number of observations above lower limit of quantification.|||nanograms per milliliter (ng/mL)||Standard Deviation|Mean
2684509|NCT01367249|Primary|Ocular Inflammation|The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15.|Day 15|LOCF Analysis, ITT Population|||eyes|Participants||Number
2681235|NCT01393964|Secondary|Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests|NCI CTCAE, version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Upper Limits of Normal (ULN). Alanine transaminase (ALT); Aspartate aminotransferase (AST); Alkaline phosphatase (ALP). ALT Grade (Gr)1:>1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. AST Gr 1: >1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 1: >1.0 to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 10..0*ULN; Gr 4: >10.0.0*ULN. ALP (U/L) Gr1:>1.0 to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:<LLN to 3 grams per deciliter (g/dL); Gr 2: <3.0 - 2.0 g/L; Gr 3: < 2 g/dL. Creatinine Gr 1: >1 - 1.5*baseline (BL)to >ULN - 1.5*ULN; Gr 2: >1.5 - 3.0*BL to > 1.5 - 3.0*ULN; Gr 3: >3.0*BL to > 3.0 - 6.0*ULN; Gr 4: >6.0*ULN.|From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)|All participants who received at least one dose of study treatment (at least one dose of any drug) were summarized.|||participants|||Number
2681236|NCT01393964|Secondary|Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests|National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Hemoglobin Gr 1:<LLN to 10.0 g/dL, Gr 2:<10.0 to 8.0 g/dL, Gr 3:<8.0 to 6.5 g/dL, Gr 4:<6.5 g/dL. Lymphocytes absolute (abs) Gr 1: <1.5 to 0.8 *10^3 c/µL, Gr 2 <0.8 to 0.5 *10^3 c/µL, Gr 3: <0.5 to 0.2 *10^3 c/µL, Gr 4: <0.2*10^3 c/µL. Neutrophils abs: Gr 1:<LLN to 1.5*10^9/L, Gr 2:<1.5 to 1.0*10^9/L, Gr 3:<1.0 to 0.5*10^9/L, Gr 4:<0.5*10^9/L. Platelet count Gr 1:LLN to 75.0*10^9/L, Gr 2:<75.0 to 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Leukocytes Gr 1:<LLN to 3.0 *10^3 c/µL, Gr 2; <3.0 to 2.0 *10^3 c/µL, Gr 3: <2.0 to 1.0 *10^3 c/µL, Gr 4: <1.0 *10^3 c/µL.|From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)|All participants who received at least one dose of study treatment (at least one dose of any drug) were summarized.|||participants|||Number
2681237|NCT01393964|Secondary|Number of Participants With Persistent Elotuzumab Anti-drug Antibodies (ADA) and Number of Participants ADA Positive at Cycle 2 Pre-dose.|Serum samples were evaluated for the presence of ADAs using a validated bridging electrochemiluminescence (ECL) immunoassay. Samples in: Cycle 1, Day 1 0 h (pre-dose), Cycle 2, Day 1(Study Day 29), 0 h (pre-dose; 672 h post-dose), Cycle 3, Day 1, 0 h and in cycle thereafter, at end of study/discontinuation, and at 30 and 60 day follow up visits post treatment. ADA Positive Participant: baseline negative with at least one ADA positive sample at any time after initiation of treatment or baseline positive with at least one ADA positive sample at any time after initiation of treatment with a titer 9-fold greater than the baseline; Persistent Positive: ADA positive at 2 or more sequential timepoints at least 12 weeks apart; Last Sample Positive: Not persistent positive and ADA Positive Sample in the last sampling timepoint; Other Positive: not persistent positive with ADA negative sample in the last sampling; ADA Negative: no ADA positive sample after the initiation of treatment.|From first dose (Day 1) to last dose plus 60 days, up to Primary Endpoint (June 2014), approximately 2 years|All participants with baseline ADA result and at least one on-treatment ADA result.|||participants|||Number
2681238|NCT01393964|Secondary|Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)|All participants who received at least one dose of study treatment (at least one dose of any drug) were summarized.|||participants|||Number
2681239|NCT01393964|Primary|Geometric Mean Area Under Serum Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) and From Time Zero Extrapolated to Infinite Time AUC(INF) of Elotuzumab Following Cycle 1, Day 1 - Grouping by C-G CrCl Method|The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD participants had 2 additional sample times: immediately prior to and immediately after dialysis. AUC was measured in µg*h/mL. PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group|Day 1 of Cycle 1 to 28 days post dose|The analyses of primary endpoint of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.|||µg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2681240|NCT01393964|Primary|Geometric Mean Maximum Observed Serum Concentration (Cmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method|The quantification of elotuzumab in human serum was performed using a validated Enzyme-linked immunoassay (ELISA). Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. Cmax was measured in micrograms per milliliter (µg/mL). Pharmacokinetic (PK) parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.|Day 1 of Cycle 1 to 28 days post dose|The analyses of primary endpoint of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2682781|NCT01381562|Primary|Laboratory Parameters of Interest- Mean Reticulocytes Over the Period of Study Duration|Absolute mean reticulocytes values recorded over the period of duration were reported.|Up to 42 days|Safety population.|||Trillion cells per Litre||Standard Deviation|Mean
2681246|NCT01393899|Secondary|Percentage of Participants Achieving a Steroid-Free Clinical Remission at Week 26 of the Maintenance Phase - Among Participants on Steroids at A3921084 Baseline|Clinical remission was a CDAI <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body eight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Week 26|mFAS who were on steroids at A3921084 Baseline|||Percentage of participants||80% Confidence Interval|Number
2681247|NCT01393899|Secondary|Kaplan-Meier Estimate of the Rate of Time to Relapse|Time to relapse was defined as increase in CDAI of more than (>)100 points from the maintenance phase baseline and a CDAI score of >220 points, or an increase to or above the baseline CDAI score in A3921083. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8 12, 20 and 26|mFAS, n=number of participants remaining at risk|||Percent Probability||80% Confidence Interval|Number
2681248|NCT01393899|Secondary|Change From Baseline in CDAI Score by Week|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity|Weeks 4, 8, 12, 20 and 26|mFAS|||Score on a scale||Standard Deviation|Mean
2681249|NCT01393899|Secondary|CDAI Score by Week|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general wellbeing, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity|Baseline and Weeks 4, 8, 12, 20 and 26|mFAS|||Score on a scale||Standard Deviation|Mean
2681250|NCT01393899|Secondary|Percentage of Participants With Sustained Clinical Response-100 (Defined as Having at Least a Clinical Response-100 at Both Weeks 20 and 26 From the A3921083 Baseline) in the Maintenance Phase|Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 20 and 26|mFAS|||Percentage of participants||80% Confidence Interval|Number
2681251|NCT01393899|Secondary|Percentage of Participants in Sustained Clinical Remission (Defined as Being in Clinical Remission at Both Weeks 20 and 26) in the Maintenance Phase|Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 20 and 26|mFAS|||Percentage of participants||80% Confidence Interval|Number
2681252|NCT01393899|Secondary|Percentage of Participants in Clinical Remission at Week 4, 8, 12, 20 and 26 Among Participants in Remission at Baseline of Maintenance Study|Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8, 12, 20 and 26|mFAS|||Percentage of participants||80% Confidence Interval|Number
2681253|NCT01393899|Secondary|Percentage of Participants in Clinical Remission at Weeks 4, 8, 12, 20 and 26|Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8, 12, 20 and 26|mFAS|||Percentage of participants||80% Confidence Interval|Number
2681254|NCT01393899|Secondary|Percentage of Participants Achieving Clinical Response-100 at Weeks 4, 8, 12, 20 and 26|Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8, 12, 20 and 26|mFAS|||Percentage of participants||80% Confidence Interval|Number
2681255|NCT01393899|Secondary|Percentage of Participants With Clinical Response-100 or Clinical Remission at Weeks 4, 8, 12 and 20|Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 4, 8, 12 and 20|mFAS|||Percentage of participants||80% Confidence Interval|Number
2681271|NCT01393730|Secondary|Change in Circulating Tumor Cells (CTCs) Levels|CTCs were measured based on established methods.|Pairs of patients' samples were evaluated at baseline and time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.|Data were not collected for this secondary endpoint.||||||
2682782|NCT01381562|Primary|Laboratory Parameters of Interest- Mean Hemoglobin Over the Period of Study Duration|Absolute mean hemoglobin values recorded over the period of duration were reported.|Up to Day 42|Safety population.|||Gram per Litre||Standard Deviation|Mean
2681256|NCT01393899|Primary|Percentage of Participants With Clinical Response-100 (as Defined by a Decrease in Crohn's Disease Activity Index [CDAI] Score of at Least 100 Points From Baseline) or Clinical Remission (CDAI Score Less Than [<]150) at Week 26|Clinical response-100 was defined as a reduction in CDAI score of at least 100 points from baseline of the parent A3921083 study. Clinical remission was a CDAI score <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for anti-diarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.|Week 26|Modified full analysis set (mFAS), defined as all randomized participants who received at least 1 dose of investigational product (ie, active or placebo study medication) in this study and who were randomized into 1 of the tofacitinib (CP-690,550) dose groups in Study A3921083.|||Percentage of participants||80% Confidence Interval|Number
2681257|NCT01393821|Secondary|Long-term Psychosocial Discomfort as Measured by the Change From Baseline in Psychological Distress Score at 4 Weeks (Treatment-regimen Estimand)|"Least Squares mean (LS) of the Psychological Distress Score change from baseline at week 4 was adjusted by treatment, week, race, gender, age (<=50 years/>50 years), and EGFR, via a MMRM analysis. Psychological Distress question (How often have you been bothered by embarrassment about your face?) with a 0-6 scale, where 0 = Never bothered and 6 = Always bothered."|Baseline, Week 4|Excludes cancel patients who never received treatment.|||score on a scale||Standard Error|Least Squares Mean
2681258|NCT01393821|Secondary|Long-term Cutaneous Discomfort as Measured by the Change From Baseline in Face Pain Scale at 4 Weeks (Treatment-regimen Estimand)|"Least Squares mean (LS) of the Face Pain Scale change from baseline at week 4 was adjusted by treatment, week, race, gender, age (<=50 years/>50 years), and EGFR, via a MMRM analysis. Face pain scale question (How would you describe how your face feels?) with a 0-10 Face Pain Scale, where 0 = No pain/burning and 10 = worst possible pain/burning."|Baseline, 4 weeks|Excludes cancel patients who never received treatment.|||score on a scale||Standard Error|Least Squares Mean
2681259|NCT01393821|Secondary|The Number of Patients Experiencing Worst Toxicity|The number of patients experiencing treatment-related adverse events (toxicities) is reported below. The maximum grade toxicity (worst toxicity) is reported by arm.|Up to 8 weeks|Excludes cancel patients who never received treatment.|||Participants|||Count of Participants
2681260|NCT01393821|Primary|Change From Baseline to Week 4 Face Pain Score Measuring Cutaneous Discomfort|"Change from baseline to Week 4 Face pain score measuring cutaneous discomfort. Face pain scale question (How would you describe how your face feels?) with a 0-10 Face Pain Scale, where 0 = No pain/burning and 10 = worst possible pain/burning."|From Baseline to Week 4|Patients who completed the face pain question at baseline and week 4 are included in this analysis.|||score on a scale||Inter-Quartile Range|Median
2681261|NCT01393743|Secondary|Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events as a Measure of Safety and Tolerability of Perampanel in Subjects With Inadequately Controlled PGTC Seizures - (for Core Study)|An Adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational product. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (i.e., the subject was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect (in the child of a subject who was exposed to the study drug). In this study, treatment emergent adverse events (TEAEs) (defined as an AE that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.|For each participant, from the first treatment dose till 30 days after the last dose or up to 21 weeks for core study and 142 weeks for extension phase.|The Safety Analysis Set included participants who were randomized to study drug, received at least 1 dose of study drug, and had at least 1 postbaseline safety assessment.|||Participants|||Number
2681262|NCT01393743|Secondary|Summary of Percent Change From Pre-Perampanel Baseline in Seizure Frequency Per 28 Days - (for Extension Phase)|Efficacy assessments included seizure counts from participant diaries. The percent change in seizure frequency was assessed during the perampanel treatment duration, with the pre-perampanel baseline being used for evaluating the change. The pre-perampanel baseline was defined as follows: 1) for all participants who had been assigned to placebo treatment in the Core Study, the pre-perampanel baseline was computed from all valid seizure diary data during the Core Study, and 2) for participants who had been assigned to perampanel in the Core Study, the pre-perampanel baseline was computed from all valid seizure diary data during the Prerandomization Phase plus the 4 weeks prior to the Prerandomization Phase of the Core Study. The perampanel treatment duration consisted of: 1) the Randomization Phase of the Core Study plus the Extension Phase for participants assigned to perampanel in the Core Study, and 2) the Extension Phase for participants assigned to placebo in the Core Study.|Weeks: 1 to 13, 14 to 26, 27 to 39, 40 to 52, 53 to 65, 66 to 78, 79 to 91, 92 to 104, 105 to 117, 118 to 130, 131 to 143, greater than or equal to 144|Full Analysis Set, which comprised all participants who were eligible to participate in the Extension Phase, received at least 1 dose of perampanel in this phase, and had baseline seizure frequency data and at least 1 observation of valid seizure diary data during the perampanel treatment duration.|||Percent change in seizure frequency||Full Range|Median
2681272|NCT01393730|Secondary|Change in Serum Androgen Levels|Serum androgen levels measured based on established methods. The change from baseline to progression was calculated for each participant.|Pairs of patients' samples for androgen analyses were obtained at baseline and at time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all treated patients.|||ng/dl||Inter-Quartile Range|Median
2681273|NCT01393730|Secondary|Presence of AR Amplification|Presence of AR amplification was measured by established methods.|Patients' samples were evaluated at baseline and every 12 weeks on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all evaluable patients.|||Participants|||Count of Participants
2681263|NCT01393743|Secondary|Percent Change From Core Study Prerandomization Phase in Primary Generalized Tonic-Clonic (PGTC) Seizure Frequency Per 28 Days - (for Extension Phase)|Week 1 began on the date of first dose of the perampanel treatment regardless of whether it occurred in the Core Study or Extension Phase and continued to and included the date of the last dose of perampanel in the Extension Phase. For any given analysis window and seizure type(s), a 50% responder from Core Study Randomization is a participant whose seizure frequency per 28 days for that seizure type(s) during that analysis window is 50% to 100% lower than his or her Core Study Prerandomization baseline seizure frequency per 28 days for that same seizure type(s). In Part B of the Extension Phase (after Visit 15), the seizure diary is only completed for days on which a seizure occurred and missing days were imputed as non-seizure days.|Date of first dose of study drug to date of last dose of study drug in the Extension Phase|Full analysis set included all participants who were eligible to participate in the Extension Phase, received at least 1 dose of perampanel in this phase, and had baseline seizure frequency data and at least 1 observation of valid seizure diary data during the perampanel treatment duration.|||Percent change in PGTC seizure frequency||Full Range|Median
2681264|NCT01393743|Secondary|50% Responder Rate for Primary Generalized Seizure Subtype During Maintenance Period - LOCF - (for Core Study)|Primary generalized seizure subtype included absence and myoclonic seizures. A responder was a participant who experienced a 50% or greater reduction in seizure frequency per 28 days during Maintenance - (LOCF) from prerandomization. The data was presented as the percentage of participants.|Baseline (4 or 8 weeks) and Maintenance (13 weeks)|Only a subset of participants in the Full Analysis Set who experienced these seizure types during the Prerandomization Phase of the study were included in this analysis.|||Percentage of participants|||Number
2681265|NCT01393743|Secondary|50% Responder Rate for All Seizures During Maintenance-LOCF - (for Core Study)|All seizures included PGTC, myoclonic, absence and all other seizures that occur during the study. A responder was a participant who experienced a 50% or greater reduction in seizure frequency per 28 days during Maintenance- LOCF from prerandomization. The data was presented as percentage of participants.|Baseline (4 or 8 weeks) and Maintenance (13 weeks)|Full Analysis Set|||Percentage of participants|||Number
2681266|NCT01393743|Secondary|Median Percent Change in Primary Generalized Seizure Subtype Frequency Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization) - (for Core Study)|Seizure frequency per 28 days was derived from the information recorded in the participant diaries. PGTC seizure frequency per 28 days was calculated as the number of PGTC seizures divided by the number of days in the interval and multiplied by 28. The percent change in seizure frequency relative to baseline (prerandomization) for primary generalized seizure subtype (myoclonic and absence) per 28 days during the Titration and Maintenance Periods combined was analyzed.|Baseline (4 or 8 weeks), Titration (4 weeks), and Maintenance (13 weeks)|Full Analysis Set|||Percent Change||Full Range|Median
2681267|NCT01393743|Secondary|Median Percent Change in All Seizure Frequency Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization) - (for Core Study)|Seizure frequency per 28 days was derived from the information recorded in the participant diaries. PGTC seizure frequency per 28 days was calculated as the number of PGTC seizures divided by the number of days in the interval and multiplied by 28. The percent change in seizure frequency relative to baseline (prerandomization) for all seizures (PGTC, myoclonic, absence and all other seizures that occur during the study) per 28 days during the Titration and Maintenance Periods combined was analyzed.|Baseline (4 or 8 weeks), Titration (4 weeks), and Maintenance (13 weeks)|Full Analysis Set|||Percent Change||Full Range|Median
2681268|NCT01393743|Primary|50% Responder Rate in Primary Generalized Tonic-Clonic Seizure Frequency Per 28 Days Relative to the Core Study Prerandomization Phase - (for Extension Phase)|Responder rate was defined as the percentage of participants who experienced a 50% or greater reduction in PGTC and total seizure frequency during treatment per 28 days relative to baseline (responder). Week 1 began on the date of first dose of the perampanel treatment regardless of whether it occurred in the Core Study or Extension Phase and continued to and included the date of the last dose of perampanel in the Extension Phase. For any given analysis window and seizure type(s), a 50% response from Core Study Prerandomization is a participant whose seizure frequency per 28 days for that seizure type(s) during that analysis window is 50% to 100% lower than his or her Core Study Prerandomization baseline seizure frequency per 28 days for that same seizure type(s). In Part B of the Extension Phase (after Visit 15), the seizure diary is only completed for days on which a seizure occurred and missing days were imputed as non-seizure days.|Week 1 of perampanel treatment to date of last dose of perampanel in the Extension Phase|The Extension Phase FAS included participants who were eligible to participate in the Extension Phase, received at least 1 dose of study drug in this phase, and had baseline seizure frequency data and at least 1 observation of valid seizure diary data during study drug treatment duration.|||Percentage of participants|||Number
2681269|NCT01393743|Primary|50% Responder Rate for Primary Generalized Tonic Clonic Seizure During Maintenance - LOCF - (for Core Study)|A responder was a participant who experienced a 50% or greater reduction in seizure frequency per 28 days during Maintenance-last observation carried forward (LOCF) from prerandomization. The data was presented as the percentage of participants.|Baseline (4 or 8 weeks) and Maintenance (13 weeks)|Full Analysis Set included all randomized participants who received as least 1 dose of study drug and had any postbaseline seizure frequency data. Last observation carried forward (LOCF).|||Percentage of participants|||Number
2681270|NCT01393743|Primary|Median Percent Change in Primary Generalized Tonic Clonic Seizure Frequency (PGTC) Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization) - (for Core Study)|Seizure frequency per 28 days was derived from the information recorded in the participant diaries. PGTC seizure frequency per 28 days (as determined from participant diaries) was calculated as the number of PGTC seizures divided by the number of days in the interval and multiplied by 28. The percent change from baseline in PGTC seizure was analyzed over the Titration and Maintenance Periods combined, while baseline was defined as seizure frequency per 28 days based on all valid diary data during the Prerandomization Phase.|Baseline (4 or 8 weeks), Titration (4 weeks), and Maintenance (13 weeks)|The Full Analysis Set included participants who were randomized to study drug, received at least 1 dose of study drug, and had any postbaseline seizure frequency data during the Randomization Phase.|||Percent change||Full Range|Median
2691734|NCT01307631|Secondary|Duration of Overall Survival|Estimated by using Kaplan-Meier analysis.|Up to 3 years|Overall survival of all patients on study.|||months||Full Range|Median
2681274|NCT01393730|Secondary|Time to Progression (TTP)|TTP based on the Kaplan-Meier method is defined as the duration of time from study entry to documented first observation of progressive disease (PD). Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|Disease evaluation occurred every 12 weeks while patients were receiving treatment. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all treated patients.|||Months||95% Confidence Interval|Median
2681275|NCT01393730|Secondary|Best Overall Response|Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.|Disease was evaluated radiologically at baseline and every 12 weeks cycles on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all treated patients.|||Participants|||Count of Participants
2681276|NCT01393730|Secondary|Time to PSA Progression|Time to PSA progression based on the Kaplan-Meier method was defined as the time between registration and documented PSA progression. PSA progression based on Prostate-Specific Antigen Working Group-2 (PSAWG-2) (2008) criteria was an increase of >/=25% and >/= 2 ng/ml after 12 weeks for patients without a PSA decline from baseline and an increase of >/=25% and >/= 2 ng/ml above the nadir, confirmed by a 2nd value 3 weeks or later for patients with a PSA decline from baseline. PSA progression was reported not duration of response.|PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all treated patients.|||months||95% Confidence Interval|Median
2681277|NCT01393730|Secondary|Prostate-Specific Antigen (PSA) Response|PSA response was defined as decline of 50% from baseline confirmed by a PSA at least 4 weeks later based on Prostate-specific Antigen Working Group-2 (PSAWG-2) (2008) criteria.|PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all treated patients.|||Participants|||Count of Participants
2681278|NCT01393730|Secondary|Change in Serum Levels of Testosterone|Serum testosterone levels were estimated based on established methods. The change from baseline to progression was calculated for each participant.|Samples for testosterone analyses were obtained at baseline and at time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all treated patients.|||ng/dL||Inter-Quartile Range|Median
2681279|NCT01393730|Primary|Number of Participants With Androgen Receptor (AR) Related Mutations|AR related mutation was defined as presence of T878A mutation. Expression of T878A was measured by established methods.|Pairs of patients samples were evaluated at baseline and time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.|The analysis dataset is comprised of all patients evaluable for AR mutation.|||Participants|||Count of Participants
2681280|NCT01393717|Secondary|Overall Survival at Year Two Among AutoHCT Patients With BV|Overall Survival (OS) defined as the time from first treatment day (post AHCT) until death. Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formula.|Assessed for up to 5 years, at least half of the surviving participants followed 2+ years|Among the 57 patients receiving BV, only 50 patients had undergone autologous transplants.|||survival probability||95% Confidence Interval|Number
2681281|NCT01393717|Secondary|Progression Free Survival at Year Two Among AutoHCT Patients With BV|Progression Free Survival (PFS) defined as the time from first treatment day (post AHCT) until objective or symptomatic relapse or death as a result of lymphoma or acute toxicity of treatment. Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formula.|Assessed for up to 5 years, at least half of the surviving participants followed 2+ years|Among the 57 patients receiving BV, only 50 patients had undergone autologous transplants.|||survival probability||95% Confidence Interval|Number
2681282|NCT01393717|Secondary|Total CD34+ Cell Dose Among Patients Receiving Brentuximab Vedotin Followed by Autologous Hematopoietic Stem Cell Transplantation|Among the patients receiving salvage Brentuximab Vedotin (BV) followed by Autologous Hematopoietic Stem Cell Transplantation (AutoHCT), their total CD34+ cell yield by stem cell mobilization.|60 days after completion of last course of study treatment, up to conditioning regimens|Among the 57 enrolled patients, 50 patients receive BV followed by AutoHCT, 32 in Cohort #1 and 18 in Cohort #2.|||x10^6 cells/kg||Full Range|Median
2681283|NCT01393717|Primary|Complete Response (CR) Rate in Cohort #2|The CR rate is calculated as the percent of evaluable patients that have confirmed CR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease.|21 days after completion of last course of study treatment, up to 5 years|Among the 20 enrolled patients in Cohort #2, all the 20 patients were evaluable for efficacy.|||percentage of participants with response||95% Confidence Interval|Number
2681284|NCT01393717|Primary|Overall Response Rate in Cohort #2|The overall response rate is calculated as the percent of evaluable patients that have confirmed CR or PR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease; Partial Response (PR), ≥50% decrease in the sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses.|21 days after completion of last course of study treatment, up to 5 years|Among the 20 enrolled patients in Cohort #2, all the 20 patients were evaluable for efficacy.|||percentage of participants with response||95% Confidence Interval|Number
2681285|NCT01393717|Primary|Complete Response (CR) Rate Among Patients With Salvage Brentuximab Vedotin (BV)|The CR rate is calculated as the percent of evaluable patients that have confirmed CR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease.|21 days after completion of last course of study treatment, up to 5 years|Among the 57 enrolled patients, only 56 patients were evaluable for efficacy.|||percentage of participants with response||95% Confidence Interval|Number
2681286|NCT01393717|Primary|Overall Response Rate Among Patients With Salvage Brentuximab Vedotin (BV)|The overall response rate is calculated as the percent of evaluable patients that have confirmed CR or PR by radiographic imaging, and the exact 95% confidence interval is calculated for this estimate. Per Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007) for target lesions and assessed by CT/PET scans: Complete Response (CR), complete disappearance of all detectable clinical and radiographic evidence of disease; Partial Response (PR), ≥50% decrease in the sum of the product of the diameters of up to six of the largest dominant nodes or nodal masses.|21 days after completion of last course of study treatment, up to 5 years|Among the 57 enrolled patients, only 56 patients were evaluable for efficacy.|||percentage of participants with response||95% Confidence Interval|Number
2681287|NCT01393704|Secondary|Total Operation Time|Time from incision to end of surgery|5 minutes postoperatively||||minutes||Standard Deviation|Mean
2681288|NCT01393704|Secondary|Number of Participants With Peri-operative Complications|Intra or post-operative complications (including but not limited to need for blood transfusion or adverse effect related to Vasopressin).|8 weeks postoperatively||||Participants|||Count of Participants
2681289|NCT01393704|Primary|Estimating Blood Loss at the End of Myomectomy - Suction Canister Estimated Blood Loss Calculation|To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome. Objective calculation of blood loss via the measurement of suction canister fluid (ml) was one of these. The calculation for estimated blood loss will be as follows: EBL = [total suction canister volume] - [volume of irrigation used] - [volume of vasopressin solution injected /2].|5 minutes post-operatively|Due to practice pattern differences among sites, there was some missing data for suction canister blood loss calculation. In these cases, total suction canister volume and/or volume of irrigation used were not measured.|||millileters||Standard Deviation|Mean
2681290|NCT01393704|Primary|Estimating Blood Loss at the End of Myomectomy - Surgeon Estimated Blood Loss|To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome: Subjective surgeon's estimate of blood loss (ml) was one measurement method.|5 minutes post-operatively||||millileters||Standard Deviation|Mean
2681291|NCT01393704|Primary|Estimating Blood Loss at the End of Myomectomy - Hematocrit Percentage|To evaluate whether volume of dilute Vasopressin administered during minimally-invasive myomectomy affects blood loss, three parameters will be collected to assess this outcome. Pre and post-operative hematocrit change (%) was one of these measurement methods.|5 minutes post-operatively|Due to practice pattern differences among sites, there was some missing data for the change in hematocrit variable, where the hematocrit either pre-operatively or post-operatively was not collected.|||hematocrit percentage||Standard Deviation|Mean
2681292|NCT01393626|Secondary|Change From Baseline EQ-5D VAS Scores at Week 8/ET Visit Using ANCOVA|"EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.~Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group & prior use of anti-TNF alpha treatments as factors.~The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data.|||mm||Standard Error|Mean
2681293|NCT01393626|Secondary|EQ-5D Visual Analogue Scale (VAS) Scores at Baseline and Week 8/ET Visit|EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data.|||mm||Standard Deviation|Mean
2681294|NCT01393626|Secondary|Change From Baseline EQ-5D Utility Scores at Week 8/ET Visit Using ANCOVA|"EQ-5D is a participant rated questionnaire to assess health-related QoL via a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain & discomfort, anxiety & depression; 1 = better health state (no problems); 3 = worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain. Score is transformed to a total score ranging from -0.594 to 1.000; higher score indicates better health state. Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group & prior use of anti-TNFα treatments as factors.~The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the number of subjects with non-missing data.|||Score on a Scale||Standard Error|Mean
2681341|NCT01393392|Secondary|Median Number of Cigarettes Smoked Per Day During the Past Week|Self-reported, median number of cigarettes per day during the previous seven days|during the previous seven days at six months post baseline|Three individuals randomized to the intensive, tailored intervention group did not attend any intervention sessions, and one participant in the control condition passed away; these individuals were not included in the analyses.|||cigarettes||Inter-Quartile Range|Median
2681295|NCT01393626|Secondary|EuroQoL 5 Dimensions Questionnaire (EQ-5D) Utility Scores at Baseline and Week 8/ET Visit|"EQ-5D is a participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range from -0.594 to 1.000; a higher score indicates a better health state."|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data.|||Score on a Scale||Standard Deviation|Mean
2681296|NCT01393626|Secondary|Change From Baseline SF-36 Component and Domain Scores at Week 8/ET Visit Using ANCOVA|"The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T scores for both the SF-36 version 2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QOL.~Adjusted means were derived from the ANCOVA model with baseline value as a covariate, treatment group and prior use of anti-TNF alpha treatments as factors.~The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data.|||Score on a Scale||Standard Error|Mean
2681297|NCT01393626|Secondary|Short Form 36 Health Survey (SF-36) Component and Domain Scores at Baseline and Week 8/ET Visit|The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T scores for both the SF-36 version 2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. Higher scores indicate better health-related QOL.|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data.|||Score on a Scale||Standard Deviation|Mean
2681298|NCT01393626|Secondary|Percentage of Participants With a Response to the Patient-Reported Treatment Impact Assessment (PRTI) at Week 8/ET Visit by Category|The IBD Patient Reported Treatment Impact Modified (PRTI) questionnaire comprises 3 individual questions administered to the participant: participant satisfaction with study treatment; participant preference for study drug over prior treatment (this question on participant preference for study drug is prefaced by a simple question of previous treatment/s for IBD received in order to place the preference question into context) and participant willingness to re-use the study treatment again. Each of these questions (except the question on previous treatment, which is informational only) is scored on a 5 point Likert scale. PSA = Patient Satisfaction Assessment; PPTA = Patient Previous Treatment Assessment; PPA = Patient Preference Assessment; PWA = Patient Willingness Assessment.|Week 8/ET visit|FAS. Number of Participants Analyzed is the number of participants in the analysis set.|||Percentage of Participants|||Number
2681299|NCT01393626|Secondary|Percentage of Participants With ≥16 Point Increase From Baseline in IBDQ Total Score at Week 8/ET Visit|The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QOL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL.|Week 8/ET visit|FAS. Number of Participants Analyzed is the number of participants in the analysis set.|||Percentage of Participants|||Number
2681300|NCT01393626|Secondary|Percentage of Participants With an IBDQ Total Score of Greater Than or Equal to (≥) 170 at Week 8/ET Visit|The IBDQ is a psychometrically validated PRO instrument for measuring disease-specific QOL in participants with IBD. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL.|Week 8/ET visit|FAS|||Percentage of Participants|||Number
2681301|NCT01393626|Secondary|Change From Baseline IBDQ Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Week 8/ET Visit Using Analysis of Covariance (ANCOVA)|"IBDQ is a validated PRO instrument for measuring QOL in IBD consisting of 32 items scored from 1 (worst response) to 7 (best response). 32 items are grouped into 4 domains scored as follows: bowel symptoms 10 - 70; systemic symptoms 5 - 35; emotional function 12 - 84; social function 5 - 35. For each domain, higher score indicates better QOL. Total score is the sum of each item score, & ranged from 32 to 224 with a higher score indicating better QOL. Positive change in total score indicated improvement in QOL.~Adjusted means were derived from an ANCOVA model with baseline value as covariate, treatment group & prior use of anti-tumor necrosis factor (TNF) alpha (α) treatments as factors.~The 15 mg BID treatment group was closed to further enrolment early in the study by Protocol Amendment 5 after only 16 participants were enrolled in this group. Therefore, the efficacy analysis was not performed for this group as the results may be difficult to interpret due to the small sample size."|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the maximum number of subjects with non-missing data.|||Score on a scale||Standard Error|Mean
2681302|NCT01393626|Secondary|Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score and Domain Scores (Bowel Function, Emotional Status, Systemic Symptoms, and Social Function) at Baseline and Week 8/ET Visit|The IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with inflammatory bowel disease (IBD). IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items are grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: bowel symptoms 10 to 70; systemic symptoms 5 to 35; emotional function 12 to 84; social function 5 to 35. For each domain, a higher score indicates better QOL. Total score is the sum of each item score, and ranged from 32 to 224 with a higher score indicating a better QOL. Positive change in total score indicated improvement in QOL.|Baseline, Week 8/ET visit|FAS. N is the number of subjects in the analysis set, Number of Participants Analyzed is the number of subjects with non-missing data.|||Score on a scale||Standard Deviation|Mean
2681303|NCT01393626|Secondary|Tofacitinib Plasma Concentrations From 0 to 2 Hours Post Dose on Day 1 and at Week 8/Early Termination (ET) Visit|Plasma samples were collected from participants for the determination of tofacitinib concentrations. Only samples from tofacitinib-treated participants were subsequently analyzed. Plasma concentration data are summarized by nominal sample collection times specified in the protocol, and actual sample collection times may be different.|Pre-dose, 20 minutes, 40 minutes, 1 hour, and 2 to 3 hours post-dose on Day 1 and Week 8/ET visit|Pharmacokinetic analysis set - included all participants who received at least one dose of study medication and had at least one measurable plasma concentration. n is the number of observations (i.e. non-missing concentrations) at each timepoint.|||nanograms per milliliter||Standard Deviation|Mean
2681304|NCT01393626|Secondary|Calprotectin Fecal Concentrations at Weeks 2, 4, and 8|Fecal calprotectin is an inflammatory marker for the gastrointestinal tract and considered as a measurement of neutrophil migration to the gastrointestinal tract. Higher values indicate more serious inflammation.|Weeks 2, 4, and 8|FAS. Number of Participants Analyzed is the number of participants in the analysis set, n is the number of participants with non-missing data.|||mg per kilogram (mg/kg)||Standard Deviation|Mean
2681305|NCT01393626|Secondary|C-Reactive Protein (CRP) Serum Concentrations at Weeks 2, 4, and 8|The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.|Weeks 2, 4, and 8|FAS. Number of Participants Analyzed is the number of participants in the analysis set, n is the number of participants with non-missing data.|||Milligrams per liter (mg/L)||Standard Deviation|Mean
2681306|NCT01393626|Secondary|CDAI Scores at Weeks 2, 4, and 8|CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.|Weeks 2, 4, and 8|FAS. Number of Participants Analyzed is the number of participants in the analysis set, n is the number of participants with non-missing data.|||Score on a scale||Standard Deviation|Mean
2681307|NCT01393626|Secondary|Percentage of Participants Achieving Either Clinical Response-100 or Clinical Remission (CDAI<150) at Weeks 2, 4, and 8|"Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. Clinical remission was a CDAI < 150 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.~The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Baseline, Weeks 2, 4, and 8|FAS, participants with missing values were treated as non-responders.|||Percentage of Participants||95% Confidence Interval|Number
2681308|NCT01393626|Secondary|Percentage of Participants Achieving Clinical Response-100 (as Defined by a Decrease in CDAI Score of at Least 100 Points From Baseline) at Weeks 2, 4, and 8|"Clinical response-100 was defined as a reduction in CDAI score from baseline of at least 100 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.~The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Baseline, Weeks 2, 4, and 8|FAS, participants with missing values were treated as non-responders.|||Percentage of Participants||95% Confidence Interval|Number
2681309|NCT01393626|Secondary|Percentage of Participants Achieving Clinical Response-70 (as Defined by a Decrease in CDAI Score of at Least 70 Points From Baseline) at Weeks 2, 4, and 8|"Clinical response-70 was defined as a reduction in CDAI score from baseline of at least 70 points. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.~The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Baseline, Weeks 2, 4, and 8|FAS, participants with missing values were treated as non-responders.|||Percentage of Participants||95% Confidence Interval|Number
2681310|NCT01393626|Secondary|Percentage of Participants in Clinical Remission (CDAI <150) at Weeks 2 and 4|"Clinical remission was a CDAI <150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.~The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Weeks 2 and 4|FAS, participants with missing values were treated as non-responders.|||Percentage of Participants||95% Confidence Interval|Number
2681354|NCT01393132|Secondary|Tear Film Break up Time|"Tear film break up time (TFBUT) was measured to evaluating the quality of tear at 56 day (+28 day follow up).~The tear film break-up time is defined as the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film.~Range : >10 seconds is thought to be normal, <5 seconds low (with high likelihood of dry eye symptoms)."|Days 56 (+28 day follow up)||||seconds||Standard Deviation|Mean
2681311|NCT01393626|Primary|Percentage of Participants in Clinical Remission (as Defined by a Crohn's Disease Activity Index [CDAI] Score of Less Than [<] 150 Points) at Week 8|"Clinical remission was a CDAI < 150 points. CDAI is a composite index consisting of a weighted scoring of 8 disease variables: number of liquid or very soft stools, extent of abdominal pain, general well-being, occurrence of extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI score was based partly on entries (7 days before evaluation) from participant's diary kept while on study. CDAI scores range from 0 to approximately 600, higher score indicates higher disease activity.~The 15 mg BID treatment group was closed to further enrolment early on in the study by Protocol Amendment 5 after only 16 participants were enrolled into this group. Therefore, the efficacy analysis was not performed for this group because the results may be difficult to interpret due to the small sample size."|Week 8|Full analysis set (FAS) – included all randomized participants who received at least 1 dose of investigational product and who had a qualified CDAI score calculated using the hematocrit value measured at baseline visit (Day 1). Participants with missing values were treated as non-responders.|||Percentage of Participants||95% Confidence Interval|Number
2681312|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety and Depression Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The anxiety/depression factor score is the sum of score from the 4 items on the anxiety/depression subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2681313|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility and Excitement Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The uncontrolled hostility/excitement factor score is the sum of score from the 4 items on the uncontrolled hostility/excitement subscale (range: 4 - best possible outcome to 28 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2681314|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thought Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The disorganized thoughts factor score is the sum of score from the 7 items on the disorganized thoughts subscale (range: 7 - best possible outcome to 49 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2681315|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The negative factor score is the sum of the 7 items of the negative subscale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2681316|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms Score.|Retrospective factor analyses have been performed in recent decades using scores for the 30 individual PANSS items to categorize symptoms into 5 dimensions. Collectively, these dimensions are referred to as the PANSS Marder Factor scores and include positive symptoms score, negative symptoms score, thought score, uncontrolled hostility/excitement, anxiety depression score. The positive factor score is the sum of the 8 components of the positive symptoms scale (range: 8 - best possible outcome to 56 - worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2681317|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Excited Component (PEC) Score.|The PEC score consisted of five PANSS items: excitement (P4), hostility (P7), tension (G4), uncooperativeness (G8), and poor impulse control (G14). Each of the items were rated on a scale of 1 (absent) to 7 (extreme). The PEC scores ranged from 5 (not present) to 35 (extremely severe).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2681318|NCT01393613|Secondary|Percentage of Participants With Discontinuation Rate for Lack of Efficacy at Week 6.|Participants discontinued for lack of efficacy during the trial were reported here.|Week 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||percentage of participants|||Number
2681319|NCT01393613|Secondary|Percentage of Participants With Response at Week 6.|The response rate was defined as reduction of ≥30% from Baseline in PANSS Total Score or CGI-I score of 1 or 2.|Week 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||percentage of participants|||Number
2692672|NCT01300650|Other Pre-specified|Interval Change From Baseline in Biomarkers (High-sensitivity C-reactive Protein, Whole Blood Assay, Brain Natriuretic Peptide)||14 days|||||||
2681320|NCT01393613|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 6.|The efficacy of trial medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at Baseline prior to the first dose of double-blind study medication. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Week 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
2681321|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Negative Subscale Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2681322|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in PANSS Positive Subscale Score.|PANSS consisted of three subscales: a total of 30 symptom constructs. For each construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive subscale score ranged from 7 (best possible outcome) to 49 (worst possible outcome). The analysis of secondary endpoints was conducted if both comparisons of brexpiprazole 4 mg/day vs placebo and brexpiprazole 2 mg/day vs placebo of the primary endpoint were significant. Although only the comparison of brexpiprazole 4 mg/day vs placebo met the gatekeeping threshold in the primary analysis, statistical testing for the other doses was reported for information.|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2681323|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in Personal and Social Performance (PSP) Score.|PSP is a validated clinician-rated scale that measures personal and social functioning in 4 domains: socially useful activities (e.g. work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.|Baseline, Week 3 and Week 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2681324|NCT01393613|Secondary|Mean Change From Baseline to Week 6 in Clinical Global Impression-Severity (CGI-S) Score.|"Severity of illness for each participant was rated using the CGI-S, which was the key secondary efficacy endpoint. To perform this assessment, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2681325|NCT01393613|Primary|Mean Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score.|The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|Baseline, Weeks 1, 2, 3, 4, 5, and 6|Efficacy sample consisted of all participants who received at least one dose of study medication and have Baseline and at least one Post-Baseline efficacy evaluation.|||Units on a scale||Standard Error|Least Squares Mean
2681326|NCT01393600|Post-Hoc|Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score for Combined NBI-98854 Dose Groups (Excluding 1 Site)|Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.|Day 15 and 29, averaged|Intent to treat (ITT) analysis set (all subjects who received at least 8 doses of study drug during Treatment Period 1 and had an AIMS dyskinesia total score value for Day 15).|||units on a scale||Standard Error|Least Squares Mean
2681327|NCT01393600|Secondary|Clinical Global Impression - Global Improvement of TD (CGI-TD)|Clinician's perspective of the participant's overall improvement of TD symptoms over time. The CGI-TD is based on a 7-point scale (range: 1=very much improved to 7=very much worse).|Day 15 and 29, averaged|Intent to treat (ITT) analysis set (all subjects who received at least 8 doses of study drug during Treatment Period 1 and had an AIMS dyskinesia total score value for Day 15).|||units on a scale||Standard Error|Mean
2681328|NCT01393600|Primary|Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score|Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.|Day 15 and 29, averaged|Intent to treat (ITT) analysis set (all subjects who received at least 8 doses of study drug during Treatment Period 1 and had an AIMS dyskinesia total score value for Day 15).|||units on a scale||Standard Error|Least Squares Mean
2681329|NCT01393457|Secondary|Number of Participants Who Completed the 10 Week Trial||10 weeks||||participants|||Number
2681330|NCT01393457|Primary|Cocaine Use Based on Urine Drug Screening|The mean of the predicted probabilities (derived from generalized linear mixed models) of negative drug screens over all 10 weeks is reported, as per the analysis proposed in the protocol.|10 weeks|intention to treat|||number of negative drug screens||Standard Deviation|Mean
2681331|NCT01393444|Secondary|Number of Participants Able to Achieve Direct Brain Control of Assistive Devices Using an Electrocorticography (ECoG)-Based Brain-computer Interface System|Participants will be asked to perform, attempt, or imagine performing motor tasks while their brain activity is recorded in order to observe the changes in neural activity during each task.|Up to 29 days of device implantation|Individuals with limited or no ability to use one or both hands due to cervical spinal cord injury, brachial plexus injury, brainstem stroke, muscular dystrophy, cerebral palsy or amyotrophic lateral sclerosis (ALS) or other motor neuron disease.|||participants|||Number
2681332|NCT01393444|Primary|Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG|Participants will attempt to control devices such as computer cursors, virtual reality environments and assistive devices such as hand orthoses or surface functional electrical stimulators using their brain activity recorded through ECoG.|Up to 29 days of device implantation|Individuals with limited or no ability to use one or both hands due to cervical spinal cord injury, brachial plexus injury, brainstem stroke, muscular dystrophy, cerebral palsy or amyotrophic lateral sclerosis (ALS) or other motor neuron disease.|||participants|||Number
2681333|NCT01393405|Other Pre-specified|Calprotectin Levels < 50 mcg/g Stool in Patients in Remission at Week 48 With Calprotectin Levels ≥ 250 mcg/g Stool at Screening|Steroid free clinical remission as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point and stool calprotectin levels of ≤ 50mcg at week 48 of the induction period in the subgroup of patients with calprotectin ≥ 250mcg/g stool at screening.|48 weeks|33/44 patient in the Methotrexate Maintenance group and 32/40 patients in the Placebo Maintenance group met the criteria of calprotectin ≥ 250 mcg/g stool at screening|||Participants|||Count of Participants
2681334|NCT01393405|Other Pre-specified|Calprotectin Levels < 50 mcg/g Stool in Patients in Remission at Week 16 With Calprotectin Levels ≥ 250 mcg/g Stool at Screening|Steroid free clinical remission as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point and stool calprotectin levels of ≤ 50mcg at week 16 of the induction period in the subgroup of patients with calprotectin ≥ 250mcg/g stool at screening.|16 weeks|134 /179 (75%) patients had a calprotectin value ≥ 250 mcg/g stool at screening.|||Participants|||Count of Participants
2681335|NCT01393405|Other Pre-specified|Calprotectin Levels <250 mcg/g Stool in Patients in Response or in Remission at Week 48 With Calprotectin Levels > 250 mcg/g Stool at Screening|Steroid free clinical remission as defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point or steroid free clinical response defined as a reduction from baseline in the clinical Mayo score of ≥ 2 points and at least 25%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of 0-1 point and a clinical Mayo score ≤5 and stool calprotectin levels <250 mcg/g stool at week 32 of the maintenance period in the subgroup of patients with calprotectin ≥ 250mcg/g stool at screening.|48 weeks|33/44 patient in the Methotrexate Maintenance group and 32/40 patients in the Placebo Maintenance group met the criteria of calprotectin ≥ 250 mcg/g stool at screening|||Participants|||Count of Participants
2681336|NCT01393405|Other Pre-specified|Calprotectin Levels <250 mcg/g Stool in Patients in Response or in Remission at Week 16 With Calprotectin Levels ≥ 250 mcg/g Stool at Screening|Steroid free clinical remission as defined as a Mayo score of ≤ 2 points with no individual subscore exceeding 1 point or steroid free clinical response defined as a reduction from baseline in the clinical Mayo score of ≥ 2 points and at least 25%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or an absolute rectal bleeding subscore of 0-1 point and a clinical Mayo score ≤5 and stool calprotectin levels <250 mcg/g stool at week 16 of the induction period in the subgroup of patients with calprotectin >250mcg/g stool at screening.|16 weeks|134 /179 (75%) patients had a calprotectin value ≥ 250 mcg/g stool at screening.|||Participants|||Count of Participants
2681337|NCT01393405|Secondary|Relapse of Disease Between Week 17-48|Relapse of disease in the Maintenance period as defined as an increase of 3 or more points in the partial Mayo clinic score (excluding sigmoidoscopy) with an absolute clinical Mayo score ≥ 4 or need for retreatment with steroids.|48 weeks||||Participants|||Count of Participants
2681338|NCT01393405|Secondary|Mucosal Healing at Week 48.|Mucosal healing is defined as an absolute Mayo subscore for endoscopy of 0 or 1|48 weeks||||Participants|||Count of Participants
2681339|NCT01393405|Primary|Relapse Free Survival Week 17-48|Relapse-free survival: Total week 48 Mayo score not exceeding 2 points, with all individual subscores not exceeding 1 point and relapse free survival defined by a numerical stable Mayo score throughout 32 weeks of maintenance therapy without increase of 3 or more points in the partial Mayo clinic score (excluding sigmoidoscopy) compared to the partial Mayo score of the individual patient at randomization at week 16 and no steroid use or other immunosuppressive medication throughout the 32 week maintenance period.|48 weeks||||Participants|||Count of Participants
2681340|NCT01393392|Secondary|Number of Participants Who Experienced Any Quit Attempts Since Enrollment|Self-reported, smoke free for 24 hours or more since baseline (yes/no)|during the period between baseline and six months post-enrollment|Three individuals randomized to the intensive, tailored intervention group did not attend any intervention sessions, and one participant in the control condition passed away; these individuals were not included in the analyses.|||Participants|||Count of Participants
2681342|NCT01393392|Secondary|Number of Participants Who Experienced Seven-day Point Prevalence of Smoking Abstinence|"Self-reported not smoking even a puff within the previous seven days, and exhaled carbon monoxide reading of <8 parts per million."|during the previous seven days at six months post baseline|Three individuals randomized to the intensive, tailored intervention group did not attend any intervention sessions, and one participant in the control condition passed away; these individuals were not included in the analyses.|||Participants|||Count of Participants
2681343|NCT01393392|Secondary|Number of Participants Who Experienced Any Quit Attempts Since Baseline|Self-reported, smoke free for 24 hours or more since baseline (yes/no)|During the period between baseline and three months post enrollment|Three individuals randomized to the intensive, tailored intervention group did not attend any intervention sessions, and one participant in the control condition passed away; these individuals were not included in the analyses.|||Participants|||Count of Participants
2681344|NCT01393392|Secondary|Median Number of Cigarettes Participants Smoked Per Day During the Past Week|Self-reported, median number of cigarettes per day during the previous seven days|during the previous seven days at three months post baseline|Three individuals randomized to the intensive, tailored intervention group did not attend any intervention sessions, and one participant in the control condition passed away; these individuals were not included in the analyses.|||cigarettes||Inter-Quartile Range|Median
2681345|NCT01393392|Primary|Number of Participants Who Experienced Seven-day Point Prevalence Smoking Abstinence|"Self-reported not smoking even a puff within the previous seven days, and exhaled carbon monoxide reading of <8 parts per million."|during the previous seven days at three months post baseline|Three individuals randomized to the intensive, tailored intervention group did not attend any intervention sessions, and one participant in the control condition passed away; these individuals were not included in the analyses.|||Participants|||Count of Participants
2681346|NCT01393301|Secondary|Treatment Related Changes in Psychological Distress.|Treatment related changes in psychological distress was measured by combining the SIGH-A, MADRS, STAI-S, and CES-D into one scale score between baseline and the 6-month follow-up. In accordance with published recommendations, each psychological measure was z-scored to put all outcomes on the same scale. A z-score below 0 indicates a level of psychological distress below the mean (lower psychological distress), while a z-score above 0 indicates a level of psychological distress above the mean (higher psychological distress).|6 months||||z-score||Standard Deviation|Mean
2681347|NCT01393301|Primary|Short-term Point Prevalence Abstinence (PPA; Pilot RCT Phase)|Smoking outcomes are assessed at end of treatment by comparing the reported 7 day abstinence (assessed through self-report and independent verification) across the randomized conditions controlling for pre-randomization levels.|10 weeks||||Participants|||Count of Participants
2681348|NCT01393301|Primary|Long-term Point Prevalence Abstinence (PPA; Pilot RCT Phase)|Smoking outcomes are assessed at 6-month follow up by comparing the reported 7 day abstinence (assessed through self-report and independent verification) across the randomized conditions controlling for pre-randomization levels.|6 months||||Participants|||Count of Participants
2681349|NCT01393301|Primary|Treatment Acceptability|"Acceptability is defined as intervention participant study completion. Study completion was defined by participants attending at least 7/10 treatment sessions.~Qualitative interviews were also conducted with participants at the end of the study."|6 months||||Participants|||Count of Participants
2681350|NCT01393158|Secondary|Change In DLQI Scores|"The dermatology life quality index (DLQI) is a validated quality-of-life scale that measures the impact of skin disease. It is a 10 question instrument. Scores of 0 over 0-1 means there is no effect on the patient's life. Scores between 2 and 5 represent a small effect on patient's life. Scores between 6 and 10 correspond to a moderate effect on patient's life. Scores between 11 and 20 correspond to a very large effect on the patient's life. And scores between 21 and 30 correspond to an extremely large effect on patient's life. The range of the scale between 0 and 30 for the added total of the patient's responses. Each question can be answered on a scale of 0-not at all, 1-a little, 2- a lot, 3- very much with some questions having the option of not relevant. The difference in DLQI score from baseline to month three (end of study) in the 20mg arm and month six (end of study) in the 30mg arm was evaluated for efficacy."|Mean change in DLQI scores measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)||||units on a scale||Standard Deviation|Mean
2681351|NCT01393158|Secondary|Change in Pruritus (Visual Analog Scale) Score|The pruritus visual analog scale (VAS) is a 10 cm (100 mm) visual analog scale that measures up patient's itch severity with 10 (100 mm) representing the worst imaginable and 0 representing no itch. This is a validated scale with a change of three from baseline to month three in the 20mg arm (end of study) and month six in the 30mg arm (end of study) being clinically relevant.|Mean change in Pruritus (Visual Analog Scale) score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)||||units on a scale||Standard Deviation|Mean
2681352|NCT01393158|Secondary|Number of Participants in Each IGA Category|The investigator global assessment scale is a gestalt global assessment made by an investigator describing the overall disease severity of the patient. It is a categorical scale that includes 0-clear, 1-almost clear, 2-mild,3- moderate, 4-severe, and 5-very severe. The reduction in IGA score from baseline to month three (end of study) in the 20mg arm and month six (end of study) in the 30mg arm was evaluated for efficacy.|Mean change in IGA score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)||||participants|||Number
2681353|NCT01393158|Primary|Change in EASI Scores|The eczema area and severity index (EASI) is a composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-72. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, population, excoriation and lichenification on a scale of 0-3 for each body of the four body regions (head/neck, trunk, arms, legs). The component measuring area is a body surface area measurement of each region. The area and severity of each body region is weighted based on size of region which are added together for the complete score. The score for each patient's with scores between 0 and 7 are considered mild ,between 7 and 21 are considered moderate, and greater than 21 are considered severe. In this study the change in EASI score between baseline and month three (end of study) in the 20 mg arm and month six in the 30 mg arm, baseline EASI score was subtracted from month 3 or month 6 score in the 30mg arm,and calculated as a final outcome data point.|Mean change in EASI score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)||||units on a scale||Standard Deviation|Mean
2681355|NCT01393132|Secondary|Ocular Discomfort Index|"Dry eye causes ocular discomfort, which is measured using a Ocular Surface Disease Index at 56 day (+28 day followup).~(Symptomatic improvement using the validated Ocular Surface Disease Index (OSDI).~The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision.~For every question, participants check a score between 0 and 4, where 0 equals none of the time and 4 equals all of the time.~OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4].~The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability."|Days 56 (+28 day follow up)||||units on a scale||Standard Deviation|Mean
2681356|NCT01393132|Secondary|Corneal Fluorescein Staining|"Ocular surface irregularity as measured by Slit Lamp Examination (SLE) with fluorescein dye staining of the cornea at days 56 (+28 day follow up).~The scale used to determine the difference in corneal fluorescein staining is the Oxford scale. (The Oxford Scale measures corneal fluorescein staining) Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The five regions were summed, for a maximum score of 25. A higher score represents greater disability."|Days 56 (+28 day follow up)||||units on a scale||Standard Deviation|Mean
2681357|NCT01393132|Primary|Safety|Sum of adverse events observed at Day 1, Day 14, Day 28 and Day 56. Measurable by Intra-ocular pressure (IOP) by applanation tonometry, Complete ophthalmologic evaluation including fundoscopy, An adverse event (baseline and all subsequent study visits).|Day 1, Day 14, Day 28 and Day 56||||event|||Number
2681358|NCT01393106|Secondary|Idelalisib Trough and Peak Plasma Concentration at Week 4|Plasma samples were collected predose (trough) and 1.5 hours postdose (peak). The minimum and maximum value among participants sampled at each time point are presented. Results of less than the lower limit of quantitation (ie, 5 ng/mL) were treated as zero prior to the achievement of the first quantifiable concentration and as missing otherwise.|Predose and 1.5 hours postdose at Week 4|Participants in the ITT Analysis Set with available data were analyzed.|||ng/mL|||Number
2681359|NCT01393106|Secondary|Compliance With Study Drug Dosing as Assessed by Accounting for Used and Unused Drug||Up to Week 110|ITT Analysis Set|||number of doses||Standard Deviation|Mean
2681360|NCT01393106|Secondary|Overall Safety Profile of Idelalisib|"The overall safety of idelalisib was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib), clinically significant abnormal electrocardiograms (ECG), and laboratory abnormalities. Clinically significant abnormalities in ECG were as determined by the investigator."|Up to Week 110|ITT Analysis Set|||percentage of participants|||Number
2681361|NCT01393106|Secondary|Changes in the Plasma Concentrations of Disease-associated Chemokines and Cytokines||Up to Week 110|This analysis was not conducted due to discrepancies with the transfer of samples.||||||
2681362|NCT01393106|Secondary|Changes in Performance Status as Documented Using the Karnofsky Performance Criteria for Participants ≥ 16 Years of Age and the Lansky Performance Criteria for Participants < 16 Years of Age|Changes in performance status were assessed using the Karnofsky performance criteria for participants ≥ 16 years of age and the Lansky performance criteria for participants < 16 years of age. Since there were no participants < 16 years of age, only the Karnofsky performance criteria were used. The change in Karnofsky performance status was reported as the best (highest change score) and worst (lowest change score) change from baseline using the Karnofsky performance criteria. The Karnofsky score classifies patients according to their functional impairment. Scores are on a scale from 0-100, the lower the score, the worse the survival for most serious illnesses.|Baseline and up to Week 110|Participants in the ITT Analysis Set with available data were analyzed.|||units on a scale||Standard Deviation|Mean
2681363|NCT01393106|Secondary|Changes in Health-related Quality of Life as Reported Using the Functional Assessment of Cancer Therapy: Lymphoma (FACT-Lym) Questionnaire|"Change in health-related quality of life was reported by participants using the FACT-Lym questionnaire assessment tool. Results are presented as the mean (SD) best change from baseline in FACT-Lym total score, which was defined as the highest change score (improvement) after baseline.~The FACT-Lym total score is on a scale from 0-168, with higher scores associated with a better quality of life."|Baseline and up to Week 110|FACT-Lym Evaluable Analysis Set: participants who had sufficient baseline and on-study measurements to provide interpretable results for this endpoint.|||units on a scale||Standard Deviation|Mean
2681364|NCT01393106|Secondary|Time to Treatment Failure|Time to treatment failure (TTF) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression, the permanent cessation of idelalisib therapy due to an adverse event, or death from any cause.|Up to Week 110|No data are presented because time to treatment failure data were not collected.||||||
2681365|NCT01393106|Secondary|Progression Free Survival|Progression free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression or death from any cause.|Up to Week 110|ITT Analysis Set|||months||95% Confidence Interval|Median
2681366|NCT01393106|Secondary|Overall Survival|Overall survival was defined as the time from start of idelalisib treatment to death from any cause.|Up to Week 110|ITT Analysis Set|||months||95% Confidence Interval|Median
2681367|NCT01393106|Secondary|Time to Response|Time to response (TTR) was defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR.|Up to Week 110|Responding Analysis Set|||months||Full Range|Median
2681368|NCT01393106|Secondary|Change From Baseline in Fluorodeoxyglucose (FDG) Uptake in Lymph Nodes as Assessed by Positron-emission Tomography (PET)||Up to Week 110|An analysis of changes in FDG uptake by the tumor was not conducted due to unavailability of lymph node biopsy samples.||||||
2681369|NCT01393106|Secondary|Percent Change From Baseline in the Sum of the Product of the Greatest Perpendicular Diameters (SPD) of Target Lymph Nodes as Documented Radiographically||Baseline, Week 8, Week 48, and up to Week 110|ITT Analysis Set|||percent change in SPD||Full Range|Median
2681370|NCT01393106|Secondary|Duration of Response|Duration of response (DOR) was defined as the interval from the first documentation of PR or CR to the earlier of the first documentation of disease progression or death from any cause.|Up to Week 110|Responding Analysis Set: participants who achieved a best response of CR or PR.|||months||95% Confidence Interval|Median
2693573|NCT01294319|Secondary|Post-dexamethasone Cortisol Level||Cortisol obtained at 8-9 AM after dexamethasone taken between 11 pm and midnight||||mcg/dL||Standard Deviation|Mean
2681371|NCT01393106|Primary|Overall Response Rate|"Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as assessed by the investigator.~CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.~PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions."|Up to Week 110|Intent-to-treat (ITT) Analysis Set: participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2681372|NCT01392989|Secondary|Pre-transplant Expression of Natural-killer Group 2, Member D (NKG2D) Ligands|Pre-transplant expression of natural-killer group 2, member D (NKG2D) ligands MIC A, MIC B, and the UL16 binding proteins (ULBPs) will be assessed in participants' bone marrow aspirates. The outcomes is expressed as the number of participants whose expression level for each ligand was elevated compared to background, represented by the known levels for individual without cancer.|Pre-transplant|Insufficient tumor sample materials from the pre-transplant diagnostic bone marrow aspirate was available for the research analysis. No analysis was conducted.||||||
2681373|NCT01392989|Secondary|Number of Participants That Experience Grade 2 to 4 aGvHD Within 100 Days and 1 Year|"Acute graft vs host disease (aGvHD) Grade 2 to 4 was staged & graded using modified Keystone criteria, as below. The outcome is reported as the number of participants that experience Grade 2 to 4 aGvHD within 100 days and 1 year.~Stage 1: Skin: rash < 25% of skin. Liver: bilirubin 2 to 3 mg/dL. Gut: diarrhea 500 to 1000 mL/day or persistent nausea with positive biopsy for GvHD~Stage 2: Skin: rash 25 to 50% of skin. Liver: bilirubin 3 to 6 mg/dL. Gut: diarrhea 1000 to 1500 mL/day.~Stage 3: Skin: rash > 50% of skin. Liver: bilirubin 6 to 15 mg/dL. Gut: diarrhea > 1500 mL/day.~Stage 4: Skin: generalized erythroderma with bulla formation. Liver: bilirubin > 15 mg/dL. Gut: severe abdominal pain with or without ileus Grade of aGvHD was determined as follows.~Grade 1: Stage 1-2 Skin + No Liver stage + No Gut stage~Grade 2: Stage 3 Skin OR Stage 1 Liver or Stage 1 Gut~Grade 3: No Skin stage + Stage 2 to 3 Liver Stage 2 to 4 Gut~Grade 4: Stage 4 Skin + or Stage 2"|1 year|Cytokine-induced killer (CIK) cells were infused in a subset of participants. Results are reported for both subsets and collectively, at 2 time points.|||Participants|||Count of Participants
2681374|NCT01392989|Secondary|Event-free Survival (EFS) Rate|Event-free Survival (EFS) rate will be assessed on all enrolled participants and is defined as the duration of time after cytokine-induced killer (CIK) cell infusion that the participants remain alive with experiencing relapse, Grade 3 to 4 acute graft vs host disease (aGVHD), or death. The outcome will be reported as the number of participants, stratified by receipt of CIK cells, that did not experience a specified event, a number without dispersion.|2 years|All participants are reported. Cytokine-induced killer (CIK) cells were infused in a subset of participants.|||Participants|||Count of Participants
2681375|NCT01392989|Secondary|Overall Survival (OS)|Overall survival (OS) is an expression of the number of participants that remain alive 2 years after cytokine-induced killer (CIK) infusion. The outcome will be reported as the number of participants alive 2 years after CIK infusion, a number without dispersion.|2 years|Cytokine-induced killer (CIK) cells were infused in a subset of participants. Participants that did not receive CIK cells were not included in this analysis.|||Participants|||Count of Participants
2681376|NCT01392989|Primary|Full Donor Chimerism (FDC)|Proportion of patients achieving full donor T-cell chimerism (FDC) by on or before Day 90 post non-myeloablative allogeneic transplant with allogeneic cytokine-induced killer (CIK) cells will be determined. FDC is defined as the attainment of >95% donor type CD3+ cells. The outcome will be reported as number of participants who achieved full donor chimerism, a number without dispersion.|90 days|Cytokine-induced killer (CIK) cells were infused in a subset of participants.|||Participants|||Count of Participants
2681377|NCT01392963|Secondary|Change From Baseline (Week 0) in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) at Week 6 (Six Weeks Post Placebo Injection at Week 0) and Week 18 (Six Weeks Post Botox Injection at Week 12)|"HDRS-21 is a validated, clinician-administered depression assessment scale. Possible scores range from 0 - 7 (within normal range or remission) 8-16 (mild depression) 17-23 (moderate depression) 24-52 (severe depression). Change = (Week 6/18 score - baseline week 0 score)~Outcome measure is the change in HDRS-21 score 6 weeks after injection with placebo (week 0) and Botox (week 12) - HDRS-21 done at week 6 and week 18."|Baseline (Week 0), Week 6, and Week 18|2 patients in the placebo first group dropped out at crossover and were not included in the 18 week assessment|||units on a scale||Standard Deviation|Mean
2681378|NCT01392963|Primary|Change From Baseline in Depression Symptoms on the Hamilton Depression Rating Scale 21 (HDRS-21) AT WEEK 6|"HDRS-21 is a validated, clinician-administered depression assessment scale. Possible scores range from 0 - 7 (within normal range or remission) 8-16 (mild depression) 17-23 (moderate depression) 24-52 (severe depression). Change = (Week 6 post injection score - baseline week 0 score).~PRIMARY OUTCOME MEASURE IS THE CHANGE IN HDRS-21 SCORE AFTER WEEK 6"|baseline and week 6|Participants that completed all study visits were included in the analysis.|||units on a scale||Standard Deviation|Mean
2681379|NCT01392742|Secondary|Percentage of Participants With Virological Response|The Virological response at the end of treatment was defined as the percentage of participants with undetectable HCV RNA, HCV test (based on a single last undetectable HCV RNA PCR falling in the 4 weeks' time window at end of treatment), is basically the sum of participants with SVR and with relapse.|4 weeks after EOT (up to Week 76)|PP population.|||percentage of participants|||Number
2681380|NCT01392742|Secondary|Cumulative Ribavirin Dose in Participants With SVR by HCV Genotype|SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.|Up to Week 72|"PP population. Here number of participants analyzed included participants evaluable for the outcome measure and n signified evaluable participants for specific HCV genotype."|||mg||Full Range|Mean
2681381|NCT01392742|Secondary|Cumulative PEG-IFN Alfa-2a Dose in Participants With SVR by HCV Genotype|SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.|Up to Week 72|"PP population. Here number of participants analyzed included participants evaluable for the outcome measure and n signified evaluable participants for specific HCV genotype."|||µg||Full Range|Mean
2681382|NCT01392742|Secondary|Duration of Treatment in Participants With SVR by HCV Genotype|SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.|Up to Week 72|"PP population. Here number of participants analyzed included participants evaluable for the outcome measure and n signified evaluable participants for specific HCV genotype."|||days||Full Range|Mean
2681383|NCT01392742|Secondary|Predictive Power Values of Host-, Virus- and Treatment-related Factors and Virological Response|Predictive value determined the relationship of host factors to virological response. Host factors included; RVR (EVR for Week 12), gender, liver fibrosis, HCV genotype, height and treatment duration for Week 4 after EOT excluding HCV genotype at Week 12 EOT. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment and EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.|Week 4 and 12|PP population. Here “number of participants analyzed” included participants who were evaluable for this outcome measure|||predictive value|||Number
2681384|NCT01392742|Secondary|Correlation of SVR With Early Virological Response (EVR)|Correlation of SVR with EVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.|Up to 24 weeks after EOT (up to Week 96)|"PP population. Here number of participants analyzed included participants who were evaluable for this outcome measure."|||correlation coefficient|||Number
2681385|NCT01392742|Secondary|Correlation of SVR With Rapid Virological Response (RVR)|Correlation of SVR with RVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment.|Up to 24 weeks after EOT (up to Week 96)|"PP population. Here number of participants analyzed included participants who were evaluable for this outcome measure."|||correlation coefficient|||Number
2681386|NCT01392742|Secondary|Percentage of Participants With Positive Predictive Value on SVR at Week 12|Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/( number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.|Week 12|"PP population. Here number of participants analyzed included participants evaluable for the outcome measure and n signified evaluable participants for specific group."|||percentage of participants|||Number
2681387|NCT01392742|Secondary|Percentage of Participants With Positive Predictive Value on SVR at Week 4|Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/(number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.|Week 4|"PP population. Here number of participants analyzed included participants who were evaluable for this outcome measure and n signified evaluable participants for specific group."|||percentage of participants|||Number
2681388|NCT01392742|Primary|Percentage of Participants Who Were Non-Responders|Non-responders were those participants who had not reached аn undetectable HCV RNA during the treatment period.|Up to 24 weeks after EOT (up to Week 96)|PP population.|||percentage of participants|||Number
2681389|NCT01392742|Primary|Percentage of Participants With Relapse|Relapse was define as аn undetectable HCV RNA during the treatment period, but without such during the follow-up.|Up to 24 weeks after EOT (up to Week 96)|PP population.|||percentage of participants|||Number
2681390|NCT01392742|Primary|Percentage of Participants With Sustained Virological Response (SVR)|SVR was defined as undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) 24 weeks after completion of the actual treatment period (a single last undetectable HCV RNA Polymerase Chain Reaction [PCR] measured greater than or equal to >=140 days post-treatment).|24 weeks after End of treatment (EOT) (up to Week 96)|Per Protocol (PP) population included all participants without any protocol violation.|||percentage of participants|||Number
2681391|NCT01392703|Secondary|Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests|Criteria for normal: bilirubin (0.2 to 1.3 mg/dL); lactate dehydrogenase (101 to 227 U/L); eosinophils (0.06 to 0.87*103 c/μL); erythrocytes (4.2 to 5.8*10^6 c/μL). Participants were required to fast for a minimum of 4 hours prior to the collection of specimens for clinical laboratory tests at screening and for at least 8 hours prior to collection on Day -1. Marked abnormalities were reported for the treatment regiment that participants received just prior to clinical laboratory testing.|Day -1, Screening, and Day 9 of current treatment regimen|All participants who received at least 1 dose of any study drug.|||Participants|||Number
2681392|NCT01392703|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs or Electrocardiogram (ECG) Findings|Blood pressure and heart rate were measured after the participant had been seated quietly for at least 5 minutes. ECG findings were recorded after the participant had been supine for at least 5 minutes. Clinically significant as reported by principal investigator.|Day -1, Screening, and Days 1, 5, 9 and 10 (at study discharge)|All participants who received at least 1 dose of any study drug.|||Participants|||Number
2681393|NCT01392703|Secondary|Number of Participants With at Least 1 Adverse Event (AE), With at Least 1 Treatment-related AE, Who Discontinued Due to AEs, and With at Least 1 Serious Adverse Event (SAE)|An AE is any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant who has received an investigational (medicinal) product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE is an untoward medical event that at any dose results in death, persistent or significant disability/incapacity; is life-threatening or a congenital anomaly/birth defect; or requires or prolongs hospitalization; is an important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention.|Continually from enrollment through Day 9 and at study discharge on Day 10|All participants who received at least 1 dose of any study drug.|||Participants|||Number
2681394|NCT01392703|Secondary|Half-life of Dasatinib||Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.|||Hours||Standard Deviation|Mean
2684367|NCT01368536|Secondary|Percentage of Responders After Treatment|Responders are defined as patients with MSSBP <130 mmHg or a decrease from baseline in MSSBP of ≥20 mmHg|Baseline, 12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
2681395|NCT01392703|Secondary|Time of Maximum Observed Plasma Concentration (Tmax) of Dasatinib|Single-dose pharmacokinetic parameters, such as Tmax, were derived using noncompartmental methods from plasma dasatinib concentration-time data.|Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.|||Hours||Full Range|Median
2681396|NCT01392703|Primary|Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-INF]) of Dasatinib|Single-dose pharmacokinetic parameters, such as AUC(0-INF) were derived using noncompartmental methods from plasma dasatinib concentration-time data.|Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2681397|NCT01392703|Primary|Area Under the Plasma Concentration-time Curve From Zero to the Last Time of the Last Quantifiable Concentration (AUC[0-T])of Dasatinib|Single-dose pharmacokinetic, such as AUC(0-T),parameters were derived using noncompartmental methods from plasma dasatinib concentration-time data.|Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2681398|NCT01392703|Primary|Maximum Observed Concentration (Cmax) of Dasatinib|Single-dose pharmacokinetic parameters, including Cmax, were derived using noncompartmental methods from plasma dasatinib concentration-time data.|Days 1-2, Days 5-6, and Days 9-10|All participants who received at least 1 dose of any study drug and had pharmacokinetic data available.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2681399|NCT01392677|Secondary|Adjusted Mean Change From Baseline in Seated Systolic Blood Pressure|To compare the change from baseline in seated systolic blood pressure (SBP) to week 8 (LOCF) between dapagliflozin and placebo|Baseline to week 8|Full Analysis Set, participants with non-missing baseline and week 8 (LOCF) values|||mmHg||95% Confidence Interval|Least Squares Mean
2681400|NCT01392677|Secondary|Proportion of Participants With HbA1c Value < 7.0% at Week 24 (LOCF)|To compare the proportion of subjects achieving a therapeutic glycemic response, defined as HbA1c <7.0%, at week 24 (LOCF) between dapagliflozin and placebo|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and week 24 (LOCF) values|||Percentage of participants||95% Confidence Interval|Least Squares Mean
2681401|NCT01392677|Secondary|Adjusted Mean Change From Baseline in Total Body Weight|To compare the change from baseline in total body weight to week 24 (LOCF) between dapagliflozin and placebo|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and week 24 (LOCF) values|||kg||95% Confidence Interval|Least Squares Mean
2681402|NCT01392677|Secondary|Adjusted Mean Change From Baseline in FPG|To compare the change from baseline in fasting plasma glucose (FPG) to week 24 (LOCF) between dapagliflozin and placebo|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and week 24 (LOCF) values|||mg/dL||95% Confidence Interval|Least Squares Mean
2681403|NCT01392677|Primary|Adjusted Mean Change From Baseline in HbA1c Levels|To compare the change from baseline in HbA1c to week 24 between dapagliflozin 10 mg in combination with metformin and sulfonylurea and placebo in combination with metformin and sulfonylurea.|Baseline to week 24|Full Analysis Set, participants with non-missing baseline and week 24 values|||Percent||95% Confidence Interval|Least Squares Mean
2681404|NCT01392625|Secondary|Measurement of Changes in Minnesota Living With Heart Failure (MLHF) Questionnaire|Measurement of Minnesota Living with Heart Failure (MLHF) Questionnaire during the 12 month follow-up period. It measures the effects of symptoms, functional limitations, and psychological distress on an individual's quality of life. The response scale for all 21 items on the MLHF is based on a 6-point. The Maximum possible scores being 126 and the minimum 0. Higher scores indicate a worse or worsening quality of life, while lower scores or decreasing scores indicate a better quality of life.|Baseline, 6 month and 12 month||||scores on a scale||Full Range|Median
2681405|NCT01392625|Secondary|Measurement of Changes in New York Heart Association (NYHA)|Measurement of New York Heart Association (NYHA) functional class during the 12 month follow-up period.|Baseline, 6 month and 12 month||||Participants|||Count of Participants
2681406|NCT01392625|Secondary|Measurement of Changes in Global Ejection Fraction|Measurement of regional left ventricular function, end diastolic and end systolic volume, measured by MRI, and or CT, and echocardiogram.|Baseline, 6 month and 12 month||||% ratio of the SV to Global EDV||Standard Deviation|Mean
2681407|NCT01392625|Secondary|Measurement of Changes in 6 Minute Walk|Measurement of Six-minute walk test during the 12 month follow-up period|Baseline, 6 month and 12 month||||meters||Standard Deviation|Mean
2681408|NCT01392625|Secondary|Measurement of Changes in Peak VO2|Measurement of Peak oxygen consumption (Peak VO2) by treadmill determination during the 12 month follow-up period.|Baseline, 6 month and 12 month||||ml/kg/min||Standard Deviation|Mean
2681409|NCT01392625|Primary|Incidence of Any Treatment-emergent Serious Adverse Events (TE-SAEs)|Incidence of TE-SAEs is defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise), or any other potential late effects detected and corroborated by clinical presentation, laboratory investigations, image analysis and when necessary with biopsy from suspected target sites in the body.|One month post-catheterization||||Participants|||Count of Participants
2681410|NCT01392573|Secondary|Change in Body Weight|Observed mean change from baseline in body weight after 26 Weeks of treatment.|Week 0, week 26|Full analysis set. Missing data was imputed using LOCF.|||kg||Standard Deviation|Mean
2681411|NCT01392573|Primary|Change From Baseline in HbA1c (Glycosylated Haemoglobin)|Observed mean change from baseline in HbA1c after 26 Weeks of treatment.|Week 0, week 26|Full analysis set. Missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2681412|NCT01392560|Primary|Change in Glomerular Filtration Rate (GFR) After 8 Weeks of Treatment With Empagliflozin Under Controlled Conditions of Euglycaemia and Hyperglycaemia|The primary endpoint is change in glomerular filtration rate (GFR) after 8 weeks of treatment with empagliflozin under controlled conditions of euglycaemia and hyperglycaemia|Baseline and 8 weeks|Per protocol set for renal (PPS_RENAL) consists of all patients who were treated with study drug and had a baseline measurement and evaluable post-dosing renal data under the clamped hyperglycemia condition for the primary endpoint.|||mL/min/1.73 m^2||Standard Error|Mean
2693589|NCT01294163|Secondary|Vital Signs||7 days|||||||
2681413|NCT01392547|Secondary|Immunogenicity (Inhibitor Development)|Immunogenicity was tested by formation of neutralising antibodies towards vatreptacog alfa and/or FVII. Radioimmunoassay using [125I]-labelled vatreptacog alfa or rFVIIa was used to screen plasma samples for development of anti-drug antibodies|Adverse events were captured from the time of consent to the end of trial visit 1 month (+14 days) after last administration of trial product.|All patients exposed to at least one dose of trial product was included in the safety analysis set. Patients received scheduled doses with rFVIIa, and treatment (rVIIa and vatreptacog alfa) for each bleeding episode.|||Subjects|||Number
2681414|NCT01392547|Secondary|Number of Adverse Events|Any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.|Adverse events were captured from the time of consent to 1 month (+14 days) after last administration of trial product.|All patients exposed to at least one dose of trial product was included in the safety analysis set. Patients received scheduled doses with rFVIIa, and treatment (rVIIa and vatreptacog alfa) for each bleeding episode.|||events|||Number
2681415|NCT01392547|Secondary|Number of Doses of Trial Product Given for Each Acute Bleed||Up to 6 hours after first trial product administration|Patients with ≥1 efficacy data point. 567 bleeds in 69 patients were treated with vatreptacog/rFVIIa in random sequence. Bleeds excluded in case of identical consecutive treatments, use of both trial products, unknown dispensing unit number.|||bleeding episodes|||Number
2681416|NCT01392547|Secondary|Effective and Sustained Bleeding Control||Up to 48 hours after first trial product administration|Patients with ≥1 efficacy data point. 567 bleeds in 69 patients were treated with vatreptacog/rFVIIa in random sequence. Bleeds excluded in case of identical consecutive treatments, use of both trial products, unknown dispensing unit number.|||bleeding episodes|||Number
2681417|NCT01392547|Primary|Effective Bleeding Control Defined as no Additional Haemostatic Medication (Other Than Trial Product) Given||Within 12 hours of first trial product administration|Patients with ≥1 efficacy data point. 567 bleeds in 69 patients were treated with vatreptacog/rFVIIa in random sequence. Bleeds excluded in case of identical consecutive treatments, use of both trial products, unknown dispensing unit number.|||bleeding episodes|||Number
2681418|NCT01392495|Secondary|Medical Resource Utilization||144 weeks|The study terminated early. No statistical analysis was performed on the efficacy outcomes.||||||
2681419|NCT01392495|Secondary|Time to Clinical Worsening (TTCW) Endpoints||144 weeks|The study terminated early. No statistical analysis was performed on the efficacy outcomes.||||||
2681420|NCT01392495|Secondary|Change From Baseline in the Six Minute Walk Distance (6MWD)||baseline, 144 weeks|The study terminated early. No statistical analysis was performed on the efficacy outcomes.||||||
2681421|NCT01392495|Primary|Number of Patients With Adverse Events, Serious Adverse Events and Deaths|Adverse event monitoring was conducted throughout the trial.|144 weeks|Safety Analysis Set: The safety analysis set included all participants who received at least one dose of study drug during the extension and had at least one post-baseline safety assessment.|||Participants|||Number
2681422|NCT01392443|Secondary|Change in Total Symptom Score From Baseline at Week 24 as Measured by Seven-day Modified MFSAF v2.0|The Seven-day modified MFSAF v2.0 is a 7-item PRO instrument based on the modified MFSAF v2.0 diary administered at specified visits. Symptoms of myelofibrosis (MF) were assessed using this instrument & included filling up quickly/early satiety, abdominal discomfort, pain under the ribs, night sweats, itching, bone/muscle pain & inactivity. The first 6 items assessed MF symptom severity at its worst as recalled & the seventh captured MF-related inactivity in the 7 days prior to the clinic visit assessment. All 7 items asked subjects to record their answers on an 11-point numeric rating scale (NRS) (0=Absent, 10=Worst Imaginable). The first 6 items of the instrument focus on MF symptoms & are summed to create a Total Symptom score, defined as the sum of the 6 individual symptom scores other than the inactivity score (each with 0-10 point scale) collected on the same week. The total symptom scale ranges from 0 -60 where higher score indicates a worse level of the condition.|Baseline, Week 24|Full Analysis Set (FAS): comprised of all patients who received at least one dose of ruxolitinib.|||scores on a scale||Full Range|Median
2681423|NCT01392443|Secondary|Change in EORTC QLQ-C30 Scores From Baseline in at Week 24|Patient reported outcomes regarding the impact of MF on patients were assessed using the EORTC QLQ-C30. Data from the EORTC QLQ-C30 questionnaire was analyzed using the standardized scores. There were 2 categories to this scale: Functional/QOL scale and Symptom and Other items scale. For each sub-scale, the raw scores were standardized in order to obtain scores ranging from 0 to 100. For Functional/QOL subscales: a higher score represents a higher/better level of functioning. For Symptoms and Other items subscales: a higher score represents worse level of symptoms. The absolute change from baseline was calculated for each scale and summarized descriptively by scheduled visit.|Baseline, Week 24|Full Analysis Set (FAS): comprised of all patients who received at least one dose of ruxolitinib.|||scores on a scale||Standard Deviation|Mean
2681424|NCT01392443|Secondary|Kaplan Meier Estimates of Duration of Response of at Least ≥ 35% Reduction From Baseline in Spleen Volume Per Kaplan Meier Estimates|For patients who had at least one ≥ 35% reduction in spleen volume from baseline at postbaseline, the duration of response was calculated. The start date of the duration was defined as the first spleen volume measurement that was ≥ 35% reduction from baseline, and the end date of the response duration was defined as the earliest of the following: death, A ≥ 25% increase in spleen volume by MRI (or CT in applicable patients) compared to baseline, Splenic irradiation, Leukemic transformation as defined by a bone marrow or a peripheral blood blast count of ≥ 20%, Splenectomy. Duration of response is calculated only for participants who achieved at least one measured >= 35% reduction in spleen volume at any time.|Weeks 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 192, 216, 240|Full Analysis Set (FAS): comprised of all patients who received at least one dose of ruxolitinib.|||weeks||95% Confidence Interval|Mean
2681425|NCT01392443|Secondary|Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Each Scheduled Time Point - Best Response|The best response rate was defined as the proportion of patients achieving a ≥ 35% reduction in spleen volume from baseline at any post-baseline assessment. The best response rate was estimated with an associated 95% confidence interval.|Weeks 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, at any time point|Full Analysis Set (FAS): comprised of all patients who received at least one dose of ruxolitinib.|||Percentage of participants||95% Confidence Interval|Number
2693590|NCT01294163|Secondary|ECG Abnormalities||7 days|||||||
2681426|NCT01392443|Primary|Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 24|The primary measure of spleen size was by MRI. MRIs were performed with a body coil because the objective was to measure organ volume only, not to assess for lesions. MRIs were performed by local radiologists who were instructed not to provide a quantitative measure of spleen volume, but could provide a qualitative assessment such as enlarged, smaller, larger, etc. The scans from an individual patient were to be read by a central reader upon transfer from the site radiologist.|24 weeks|Full Analysis Set (FAS): comprised of all patients who received at least one dose of ruxolitinib.|||Participants|||Count of Participants
2681427|NCT01392378|Secondary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for toddler dose were events between toddler dose and up to 1 month (28 to 42 days) after toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).|Toddler dose up to 1 Month (28 to 42 days) after toddler dose|Safety analysis set toddler dose included all participants who receive toddler dose of 13vPnC or INFANRIX hexa and had AE or temperature data available.|||participants|||Number
2681428|NCT01392378|Secondary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events after the infant series were events between 1 month (28 to 42 days) after infant series to toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs spontaneously collected on case report form (non-systematic assessment).|1 Month (28 to 42 days) after infant series Dose 3 up to toddler dose|Safety analysis set Dose 3 included all participants who receive Dose 3 of 13vPnC or INFANRIX hexa in infant series and had AE or temperature data available.|||participants|||Number
2681429|NCT01392378|Secondary|Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series|An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for infant series were events between infant series Dose 1 and up to 1 month (28 to 42 days) after infant series that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).|Baseline up to 1 Month (28 to 42 days) after infant series|Safety analysis set Dose 1 included all participants who receive Dose 1 of 13vPnC or INFANRIX hexa in infant series and had AE or temperature data available.|||participants|||Number
2681430|NCT01392378|Secondary|Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose|Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C.|Within 4 days after toddler dose|Safety analysis set toddler dose: participants who receive toddler dose of 13vPnC or INFANRIX hexa and had AE or temperature data available. ‘N’ (number of participants analyzed) =participants reported yes for >=1 day or no for all days, ‘n’ =participants reporting yes for >=1 day or no for all days for specified event for each arm, respectively.|||percentage of participants|||Number
2681431|NCT01392378|Secondary|Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3|Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C. Report of fever >40 degrees C after 13vPnC Infant Series Dose 3 was confirmed as data entry error.|Within 4 days after infant series Dose 3|Safety analysis set Dose 3: participants who received Dose 3 of 13vPnC/INFANRIX hexa in infant series and had AE or temperature data available. ‘N’ (number of participants analyzed) =participants reported yes for >=1 day or no for all days, ‘n’=participants reporting yes for >=1 day or no for all days for specified event for each arm respectively.|||percentage of participants|||Number
2681441|NCT01392378|Secondary|Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series|Geometric LS mean concentrations (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||titer||95% Confidence Interval|Geometric Mean
2681526|NCT01391858|Primary|The Postoperative Opioid Requirement After Mastectomy|IV Patient Controlled Analgesia (PCA) morphine for rescue pain management in the immediate postoperative period for an average of 24 hrs after mastectomy|Participants received PCA pump, an average of 24 hrs after mastectomy||||milligram (mg)||Inter-Quartile Range|Median
2693591|NCT01294163|Secondary|Clinical Laboratory Tests||7 days|||||||
2681432|NCT01392378|Secondary|Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2|Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree C, >39 but <=40 degree C and >40 degree C.|Within 4 days after infant series Dose 2|Safety analysis set Dose 2: participants who received Dose 2 of 13vPnC/INFANRIX hexa in infant series and had AE or temperature data available. ‘N’ (number of participants analyzed) =participants reported yes for >=1 day or no for all days, ‘n’=participants reporting yes for >=1 day or no for all days for specified event for each arm respectively.|||percentage of participants|||Number
2681433|NCT01392378|Secondary|Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1|Participants' core (rectal) temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: >=38 but <=39 degree Celsius (degree C), greater than (>) 39 but <=40 degree C and >40 degree C.|Within 4 days after infant series Dose 1|Safety analysis set Dose 1: participants who received Dose 1 of 13vPnC/INFANRIX hexa in infant series, had Adverse Event (AE) or temperature data. ‘N’(number of participants analyzed)=participants reported yes for >=1 day or no for all days, ‘n’=participants reporting yes for >=1 day or no for all days for specified event for each arm respectively.|||percentage of participants|||Number
2681434|NCT01392378|Secondary|Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose|Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.8 EU/mL, FHA >=46.5 EU/mL, PRN >=43.5 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate antibody concentration or titer to the given concomitant vaccine antigen for each arm respectively.|||percentage of participants||95% Confidence Interval|Number
2681435|NCT01392378|Secondary|Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series|Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate [PRP] >=0.15 mcg/mL; Hib PRP >=1 mcg/mL; Pertussis PT >=14.6 EU/mL, FHA >=16.1 EU/mL, PRN >=24.0 EU/mL; Tetanus >=0.1 IU/mL; Diphtheria >=0.1 IU/mL; HBV >=10 mIU/mL; Poliomyelitis Type 1, 2, 3 >=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate antibody concentration or titer to the given concomitant vaccine antigen for each arm respectively.|||percentage of participants||95% Confidence Interval|Number
2681436|NCT01392378|Secondary|Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||titer||95% Confidence Interval|Geometric Mean
2681437|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured in mIU/mL and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.|||mIU/mL||95% Confidence Interval|Geometric Mean
2681438|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured in IU/mL and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.|||IU/mL||95% Confidence Interval|Geometric Mean
2681439|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured in EU/mL and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.|||EU/mL||95% Confidence Interval|Geometric Mean
2681440|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose|Geometric LS mean concentration (GMCs) were measured in mcg/mL and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.|1 month after the toddler dose|mITT toddler immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.|||mcg/mL||95% Confidence Interval|Geometric Mean
2681442|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series|Geometric LS mean concentration (GMCs) were measured in milli international units/mL (mIU/mL) and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.|||mIU/mL||95% Confidence Interval|Geometric Mean
2681443|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series|Geometric LS mean concentration (GMCs) were measured in International Units/mL (IU/mL) and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.|||IU/mL||95% Confidence Interval|Geometric Mean
2681444|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series|Geometric LS mean concentration (GMCs) were measured in Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin [PT], filamentous hemagglutinin [FHA] and pertactin [PRN]) antibodies.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.|||EU/mL||95% Confidence Interval|Geometric Mean
2681445|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series|Geometric LS mean concentrations (GMCs) and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.|||mcg/mL||95% Confidence Interval|Geometric Mean
2681446|NCT01392378|Secondary|Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series|Antibody-mediated serum OPA against the 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate OPA titer to the given serotype for each arm respectively.|||titer||95% Confidence Interval|Geometric Mean
2681447|NCT01392378|Secondary|Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series|Percentage of participants achieving serotype-specific pneumococcal OPA titer >= LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. The OPA LLOQ in titers for each serotype: 1 = 1:18; 3 = 1:12; 4 = 1:21; 5 = 1:29; 6A = 1:37; 6B = 1:43; 7F = 1:210; 9V = 1:345; 14 = 1:35; 18C = 1:31; 19A = 1:18; 19F = 1:48; 23F = 1:13.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate IgG concentration to the given serotype for each arm respectively.|||percentage of participants||95% Confidence Interval|Number
2681448|NCT01392378|Secondary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose|Antibody geometric LS mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm respectively.|1 month after the toddler dose|mITT toddler immunogenicity set: eligible participants who had >=1 valid,determinate assay result, 56-98 days of age at Vaccination 1, received antipyretic regimen as per randomization, received all vaccinations, may have had received additional anti-pyretic medication, had blood drawn within specified time frames, had no major protocol violations.|||mcg/mL||95% Confidence Interval|Geometric Mean
2681449|NCT01392378|Secondary|Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series|Percentage of participants achieving predefined antibody threshold >=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.|1 month after the infant series|mITT infant immunogenicity population. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure and ‘n’ signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|||percentage of participants||95% Confidence Interval|Number
2681450|NCT01392378|Primary|Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series|Antibody geometric least squares (LS) mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) confidence interval (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.|1 month after the infant series|Modified intent-to-treat (mITT) infant immunogenicity set: all eligible participants who had >=1 valid,determinate assay result, 56-98 days of age at Vaccination 1, received antipyretic regimen as per randomization,may have had received additional anti-pyretic medication,had blood drawn within specified time frames,had no major protocol violations.|||microgram per milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
2681453|NCT01392326|Secondary|Change From Baseline for Joint/Bone Structural Damage (Van Der Heijde Modified Total Sharp Score) for Secukinumab 75 and 150 mg (Pooled Doses)|Measured are 44 joints for erosions: scored 0 to 5 in hands; 0 to 10 in feet;40 joints for joint space narrowing; summed for total score by two experienced readers scored every film blinded to patient identity, treatment, sequence of film. Lower score equals better outcome. With score of zero being normal. Joint structural damage change from baseline at Week 24 using non-parametric ANCOVA, Linear extrapolation. Estimate (for the difference in mean), SE are from a non-parametric ANCOVA model with the change from baseline van der Heijde total modified Sharp score as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.|Week 24|.Full analysis set.|||units on a scale||Standard Error|Mean
2681454|NCT01392326|Secondary|Percent of Patients Achieving ACR50 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo|ACR50 = 50 % improvement in at least 3 of the 5 measures( Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR) and 50 % improvement in the swollen and tender joint count.|Week 24|Full analysis set|||% participant|||Number
2681455|NCT01392326|Secondary|Change From Baseline in HAQ-DI for Secukinumab 75 or 150 mg|"HAQ-DI, assesses a patient's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The stem of each item asks over the past week Are you able to … perform a particular task. The patient's responses are made on a scale from zero (no disability) to three (completely disabled)."|Week 24|Full Analysis Set|||units on a scale||Standard Error|Least Squares Mean
2681456|NCT01392326|Secondary|Change From Baseline in SF36-PCS for Secukinumab 75 or 150 mg|The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.|Week 24|Full Analysis Set|||units on scale||Standard Error|Least Squares Mean
2681457|NCT01392326|Secondary|Change From Baseline in DAS28-CRP for Secukinumab 75 or 150 mg|"DAS-CRP values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS-CRP below the value of 2.6 is interpreted as Remission.DAS28 the DAS-CRP uses 28 different joints for its calculation: proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2) With the above mentioned parameters, DAS-CRP is calculated as: <math>DAS-CRP=0.56 \times \sqrt{TEN28} + 0.28 \times \sqrt{SW28} + 0.36 \times \ln(CRP+1) + 0.014 \times SA+0.96</math> With: TEN28: number of joints with tenderness upon touching SW28: number of swollen joints CRP: C-reactive Protein SA: subjective assessment of disease activity by the patient during the preceding 7 days on a scale betweenn 0 and 100 (0:no activity, 100: highest activity possible)"|Week 24|Full Analysis Set|||units on scale||Standard Error|Least Squares Mean
2681458|NCT01392326|Secondary|Percent of Subjects Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline|A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis|Week 24|Full Analysis Set|||% of participants acheiving goal|||Number
2681459|NCT01392326|Secondary|Percent of Subjects Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline|A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials with end points of psoriasis|Week 24|Full Analysis Set|||% participants acheiving goal|||Number
2681460|NCT01392326|Primary|Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo|A patient will be considered as improved according the ACR20 criteria if she/he has at least 20 % improvement in the two following measures:Tender joint count,Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR)|Week 24|Full analysis set|||% participant|||Number
2681461|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681462|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681463|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681464|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681465|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681466|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681467|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681468|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681469|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681470|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681471|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681472|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681473|NCT01392300|Secondary|Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681474|NCT01392300|Secondary|Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681475|NCT01392300|Secondary|Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain|The Disability Assessment Scale consists of the four domains hygiene, dressing, limb position, and pain which were assessed on a 4-point scale with the values 0 (=no disability), 1 (=mild disability), 2 (=moderate disability), and 3 (=severe disability).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681476|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681477|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681478|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681479|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681480|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681481|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681482|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681607|NCT01391273|Primary|Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)|The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.|Baseline, Month 4|Intent to treat population included all randomized participants.|||Percentage of participants|||Number
2681483|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681484|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681485|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681486|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681487|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681488|NCT01392300|Secondary|Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681489|NCT01392300|Secondary|Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681490|NCT01392300|Secondary|Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681491|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
2681650|NCT01390857|Secondary|Number of Participants With Any Unexpected Adverse Drug Reactions|An unexpected adverse drug reaction is an adverse event whose casual relationship to the study drug is not ruled out by the reporting physician and also is not listed in a package insert of the drug.|1 month|ITT Safety Population|||participants|||Number
2681492|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
2681493|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
2681494|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
2681495|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
2681496|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
2681497|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
2681498|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
2681499|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
2681500|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
2693592|NCT01294163|Secondary|Presence or Absence of Postoperative Delirium|Confusion Assessment Method|7 days|||||||
2681501|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
2681502|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
2681503|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
2681504|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
2681505|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist|The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
2681506|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern|Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 12|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
2681507|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern|Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 8|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
2681508|NCT01392300|Secondary|Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern|Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. Subjects with a reduction of one point were defined as responder for the aim of the efficacy analysis.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by worst case (=non-responder).|||participants|||Number
2681509|NCT01392300|Primary|Investigator's Global Impression of Change|This is the co-primary outcome measure. The Global Impression of Change Scale [GICS] is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point Likert scale that ranges from -3 = very much worse to +3 = very much improved.|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by zero change (worst case).|||units on a scale||Standard Error|Least Squares Mean
2681527|NCT01391819|Secondary|Number of Laboratory Confirmed Dengue Episodes Associated With Clinical Symptoms|Dengue related clinical symptoms included general symptoms, digestive symptoms, respiratory symptoms, hemorrhagic symptoms and any other signs among first symptoms.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||dengue infection cases|||Number
2681510|NCT01392300|Primary|Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern|"Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow.~The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension)."|Week 4|Full Analysis set (all subjects who were randomized after the Amended Protocol Version 3.0, dated 11-MAY-2012 became effective, who were treated, and for whom at least an AS baseline value for the primary target clinical pattern is given). Missing values were imputed by the last observation carried forward (LOCF) approach.|||units on a scale||Standard Error|Least Squares Mean
2681511|NCT01392170|Primary|Number of Participants Achieved of Major Molecular Response (MMR) or Complete Molecular Response (CMR)|Molecular response defined as: major molecular response (MMR) corresponds to a BCR-ABL1/ABL1 ratio of <=0.01. Complete molecular response (CMR) is defined as undetectable BCR-ABL1 transcripts. Molecular response measured every 3 months (a total of 4 assessments within one year of therapy).|12 months from start of treatment with PEG-IFNá-2a|Study terminated due to low accrual. No participants were evaluable for outcome.||||||
2681512|NCT01392053|Secondary|Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period.|Considering the first labour to be a unique experience to every women, and also a moment of many doubts and insecurities, it is considered that the presence of a healthcare professional, providing information and support, during this moment, could be benefitial to most first time mothers. Therefore, the presence of a physiotherapist could have helped minimize the suffering in both groups. The questionnaire applied after labour intended to assess how most women felt regarding this subject.|30 minutes|All patients participatin in the study answered a satisfaction questionnaire after labour.|||participants|||Number
2681513|NCT01392053|Secondary|Obstetric Outcomes - Moment of Utilization of Oxytocin|Oxytocin is a drug used to induce or enhance the muscular activity of the uterus. In this study, the moment when this event happened was associated to the dilation of the uterus cervyx, considering this to be a more reliable data rather than the timelapse of labor. This outcome is measured in centimeter when the women is assessed by the doctor.|10 hours|All patients in both groups were analyzed|||centimeters||Standard Deviation|Mean
2681514|NCT01392053|Secondary|Obstetric Outcome - Moment of Corioamniorrhexis|Corioamniorrhexis may occur during the normal evolution of labour or due to medical conditions. In this study, the moment when this event happened was associated to the dilation of the uterus cervyx, considering this to be a more reliable datum rather than the timelapse of labor. This outcome is measured in centimeter when the women is assessed by the doctor.|10 hours|All patients in both groups were analyzed|||centimeters||Standard Deviation|Mean
2681515|NCT01392053|Secondary|Obstetric Outcomes - Duration of Labour|"The time elapsed between hospital admission and delivery was measured to compare the influence of the procedures established in the study design. It was defined two sets of measures dichotomizing the groups into up to 7 hours or more than 7 hours."|10 hours|All patients in both groups were analyzed|||percentage of participants|||Number
2681516|NCT01392053|Secondary|Obstetric Outcomes - Delivery|Labour can either occur via vaginal canal, also called natural birth, or via caesarian section, which is a surgical procedure used when either the mother or the baby are in distress.|10 hours|All patients of both groups were analyzed.|||participants|||Number
2681517|NCT01392053|Secondary|Pharmacological Analgesia Request According to the Cervical Dilation.|In the institution where this study was conducted, the request for analgesia, made by the patient, is granted promptly. Considering that the further the cervyx dilation grows, the greater the pain intensity is, the cervical dilation was used as an indicator of the moment that the women in labour requested this procedure, and, therefore, could provide a comparison between methods.|10 hours|Of the 46 patients who where evaluated, only 1 (one) in each group didn't request pharmacological analgesia and, thus, were excluded of the analysis of this specific outcome|||centimeters||Standard Deviation|Mean
2681518|NCT01392053|Primary|Effectiveness of Massage Therapy in Pain Relief During Labor.|The Visual Analogue Scale was used to assess the pain intensitiy after each procedure according to the study design. The VAS is a scale composed by a straight line printed on a paper measuring 100 milimeters, where only the 0 (Zero) and the 100 (one hundred) points are marked. The patient is then asked to mark this line accordingly to the intensity of the pain felt in that moment, considering 0 (Zero) to be no pain at all, and 100 (one hundred) to be the most unbearable pain ever suffered. The researcher would measure the distance, in milimeters, from the 0 (Zero)mm to the point were the patient marked, wich was considered to be the intensity of the pain felt by the patient in that moment. A reduction of 13mm or more in this scale is considered to be a significative pain reduction.|30 minutes|A pilot study was conducted previously to determine the size of the population needed. Using a paired sample t-test, with a power of 95% and 5% significance level, it was determined a minimum of 12 patients for Control Group and 16 patients for Massage Group|||milimeters||Standard Deviation|Mean
2681519|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed after discharge on the 90th day after mastectomy||||units on a scale||Inter-Quartile Range|Median
2681520|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed after discharge on the 30th day after mastectomy||||units on a scale||Inter-Quartile Range|Median
2681521|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed after discharge on the 14th day after mastectomy||||units on a scale||Inter-Quartile Range|Median
2681522|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed after discharge on the 7th day after mastectomy||||units on a scale||Inter-Quartile Range|Median
2681523|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed at hospital discharge, an average of 3 days after mastectomy||||units on a scale||Inter-Quartile Range|Median
2681524|NCT01391858|Secondary|Pain Scores|Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)|Participants` pain score was assessed on the first postoperative day after mastectomy||||units on a scale||Inter-Quartile Range|Median
2681528|NCT01391819|Secondary|Number of Dengue Infection Episodes With Any Temperature Interval Since Onset of Suspected Dengue Cases, Among Laboratory Confirmed Dengue Cases|Temperature intervals assessed varied from hypothermia 33.5 to 36.4 degrees Celsius (°C), to normal temperature 36.5-35.9 °C and hyperthermia 37 - 39.9 °C, or were unknown.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||dengue infection cases|||Number
2681529|NCT01391819|Secondary|Number of Dengue Infection Episodes - Clinical Symptom Since Onset of Suspected Dengue Cases: Temperature|Temperature, expressed in degrees Celsius (°C), was among symptoms of symptomatic dengue infection.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||°C||Standard Deviation|Mean
2681530|NCT01391819|Secondary|Number of Hospitalization Days Due to Laboratory Confirmed Dengue Cases|Length of hospitalization was part of the direct medical resource, associated with dengue infection.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Days||Standard Deviation|Mean
2681531|NCT01391819|Secondary|Number of Symptomatic Dengue Laboratory Confirmed Cases Associated With Hospitalization Direct Medical Resource|Direct medical resource included hospitalization, stay in intensive care units (ICU), medications, diagnostic and therapeutic procedures|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Dengue infection cases|||Number
2681532|NCT01391819|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) were collected on the enrolled subjects. SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 to Year 3|The analysis was performed on the Total cohort, which included all subjects enrolled in the study.|||Participants|||Count of Participants
2681533|NCT01391819|Secondary|Number of Laboratory Confirmed Dengue Infection Cases Associated With Subjects Absenteeism|The number of laboratory confirmed dengue infection cases with subjects missing from school due to dengue infection were recorded as part of the dengue active surveillance and indirect resource utilization associated with symptomatic dengue infection.|From 21 up to 35 days post laboratory confirmed dengue onset|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Dengue infection cases|||Number
2681534|NCT01391819|Secondary|Number of School Days Missed by Subjects|The number of school days missed by subjects due to dengue infection were recorded as part of the dengue active surveillance and indirect resource utilization associated with symptomatic dengue infection.|From 21 up to 35 days post laboratory confirmed dengue onset|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Days||Standard Deviation|Mean
2681535|NCT01391819|Secondary|Number of Laboratory Confirmed Dengue Infection Cases Associated With Caregiver Absenteeism|The number of laboratory confirmed dengue infections with primary caregivers missing from work was recorded as part of health economics indirect resource utilization associated with symptomatic dengue infection.|From 21 up to 35 days post laboratory confirmed dengue onset|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Dengue infection cases|||Number
2681536|NCT01391819|Secondary|Number of Working Days Missed of Primary Care Giver 2 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases|The number of days off work from caregiver were recorded as part of health economics indirect resource utilization associated with symptomatic dengue infection.|From 21 up to 35 days post laboratory confirmed dengue onset|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Days||Standard Deviation|Mean
2681537|NCT01391819|Secondary|Number of Working Days Missed of Primary Care Giver 1 of Subjects With Laboratory Confirmed Symptomatic Dengue Cases|The number of days off work from caregiver were recorded as part of health economics indirect resource utilization associated with symptomatic dengue infection.|From 21 up to 35 days post laboratory confirmed dengue onset|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Days||Standard Deviation|Mean
2681538|NCT01391819|Secondary|Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases|"Secondary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seropositive. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore the category number of subjects analysed has been populated with the number of enrolled subjects seropositive for anti-dengue IgG antibodies before the specified season and attended the study visit after the specified season, and in each age stratum."|At Year 3 (2014)|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Dengue infection cases|||Number
2681670|NCT01390818|Secondary|Apparent Terminal Half-Life (t1/2) of SAR245409||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||hour||Full Range|Median
2681539|NCT01391819|Secondary|Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases|"Secondary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seropositive. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore the category number of subjects analysed has been populated with the number of enrolled subjects seropositive for anti-dengue IgG antibodies before the specified season and attended the study visit after the specified season, and in each age stratum."|At Year 2 (2013)|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Dengue infection cases|||Number
2681540|NCT01391819|Secondary|Number of Secondary Laboratory Confirmed Symptomatic Dengue Infection Cases|"Secondary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seropositive. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore the category number of subjects analysed has been populated with the number of enrolled subjects seropositive for anti-dengue IgG antibodies before the specified season and attended the study visit after the specified season, and in each age stratum."|At Year 1 (2012)|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Dengue infection cases|||Number
2681541|NCT01391819|Secondary|Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases|"Primary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seronegative. Analysis was done by calendar year and age strata. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore the category number of subjects analysed has been populated with the number of enrolled subjects seronegative for anti-dengue IgG antibodies before the specified season and attended the study visit after the specified season, and in each age stratum."|At Year 3 (2014)|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Dengue infection cases|||Number
2681542|NCT01391819|Secondary|Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases|"Primary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seronegative. Analysis was done by calendar year and age strata. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore the category number of subjects analysed has been populated with the number of enrolled subjects seronegative for anti-dengue IgG antibodies before the specified season and attended the study visit after the specified season, and in each age stratum."|At Year 2 (2013)|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Dengue infection cases|||Number
2681543|NCT01391819|Secondary|Number of Primary Laboratory Confirmed Symptomatic Dengue Infection Cases|"Primary symptomatic dengue infection cases are defined as laboratory confirmed symptomatic dengue cases whose previous sample collected at scheduled visits to detect anti-dengue IgG antibodies were seronegative. Analysis was done by calendar year and age strata. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore the category number of subjects analysed has been populated with the number of enrolled subjects seronegative for anti-dengue IgG antibodies before the specified season and attended the study visit after the specified season, and in each age stratum."|At Year 1 (2012)|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Dengue infection cases|||Number
2681544|NCT01391819|Secondary|Number of Dengue Infection Cases by Virus Type (DENV)|Among virus types causing dengue infection were DENV-4 in 2012 and 2013 and DENV-1 in 2014, as assessed by PCR.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Dengue infection cases|||Number
2681545|NCT01391819|Secondary|Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection|"Incidence of laboratory confirmed or probable symptomatic dengue infection was assessed by calendar year and age strata. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category number of subjects analysed has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum."|At Year 3 (2014)|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Cases in 1000 person-years||95% Confidence Interval|Number
2681546|NCT01391819|Secondary|Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection|"Incidence of laboratory confirmed or probable symptomatic dengue infection was assessed by calendar year and age strata. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category number of subjects analysed has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum."|At Year 2 (2013)|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Cases in 1000 person-years||95% Confidence Interval|Number
2684377|NCT01368497|Secondary|Absence of Detectable Antiviral Drug-resistance HBV Mutations||End of treatment (up to 48 weeks)||2020-08-31|08/2020||||
2681547|NCT01391819|Secondary|Incidence of All Laboratory-confirmed or Probable Symptomatic Dengue Infection|"Incidence of laboratory confirmed or probable symptomatic dengue infection was assessed by calendar year and age strata. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category number of subjects analysed has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum."|At Year 1 (2012)|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Cases in 1000 person-years||95% Confidence Interval|Number
2681548|NCT01391819|Secondary|Number of Subjects With Laboratory Confirmed or Probable Dengue Cases According Symptomatic Dengue Definition (Primary, Secondary or Unknown) Among the Suspected Dengue Cases|A case of primary or secondary symptomatic dengue infection was defined as laboratory confirmed or probable symptomatic dengue case whose previous sample collected at scheduled Visits 1- 4 (Day 0- Year 3) to detect anti-dengue IgG antibodies was seronegative or seropositive, respectively. A probable dengue case was defined as a suspected symptomatic dengue case with the following laboratory findings: -anti-dengue IgM or anti-dengue IgG positivity in at least one sample (in either blood sample 1 or 2) AND no evidence of viremia (negative dengue virus identification through RT-qPCR) in blood sample 1 AND no evidence of anti-dengue Ig M or IgG seroconversion between blood sample 1 and blood sample 2.|From Year 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Participants|||Count of Participants
2681549|NCT01391819|Secondary|Proportion of Subjects With Primary Asymptomatic Dengue Infection|Asymptomatic dengue primary infection was defined as a documented seroconversion (anti-dengue IgG antibodies) between two sequential sera samples obtained during the scheduled visits, without suspicion of dengue. Proportion of asymptomatic dengue primary infection was analyzed among subjects who had no past dengue infection reported before the beginning of the period.|From Day 0 to Year 3|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||proportion of subjects||95% Confidence Interval|Number
2681550|NCT01391819|Secondary|Proportion of Subjects With Prevalence of Past Dengue Infection (Dengue Seroprevalence) at Enrollment|This outcome measures the occurrence of past dengue infections among subjects who had laboratory results. Proportion was estimated from logistic generalized estimating equations models (GEE) taking the clustering effect of the school into account and was presented per subject enrolment age. Immune response against dengue was assessed via Enzyme-linked Immunosorbent Assay (ELISA).|At Day 0 (At enrollment)|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Proportion of subjects||95% Confidence Interval|Number
2681551|NCT01391819|Primary|Incidence of All Laboratory-confirmed Symptomatic Dengue Infection|"Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through dengue virus identification through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category number of subjects analysed has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum."|At Year 3 (2014)|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Cases in 1000 person-years||95% Confidence Interval|Number
2681552|NCT01391819|Primary|Incidence of All Laboratory-confirmed Symptomatic Dengue Infection|"Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through dengue virus identification through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category number of subjects analysed has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum."|At Year 2 (2013)|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Cases in 1000 person-years||95% Confidence Interval|Number
2681553|NCT01391819|Primary|Incidence of All Laboratory-confirmed Symptomatic Dengue Infection|"Laboratory-confirmed dengue infection refers to suspected symptomatic dengue cases with positive dengue virus identification or serologic evidence of dengue infection through dengue virus identification through Reverse Transcriptase quantitative Polymerase Chain Reaction (RT-qPCR) from first blood sample or anti-dengue Immunoglobulin type M/G (IgM/G) seroconversions between first and second blood sampling. Note: In the study report the denominator for incidence estimation has not been expressed as an absolute number of subjects, but in person-years. Therefore, the category number of subjects analysed has been populated with the number of enrolled subjects attended the study visit after the specified season and in each age stratum."|At Year 1 (2012)|The analysis was performed on the According-To-Protocol (ATP) cohort, which included all subjects meeting all eligibility criteria of the study, with no elimination criteria during the study and complying with the procedures defined in the protocol.|||Cases in 1000 person-years||95% Confidence Interval|Number
2681690|NCT01390649|Secondary|Responder Rate|The responder rate is the percentage of subjects who have a platelet response (defined as a platelet count increase at least once to ≥ 50 x 10^9/L after the first IgPro10 administration).|Within 6 days after the first infusion|Full analysis set: all subjects who received at least 1 IgPro10 infusion.|||percentage of participants||95% Confidence Interval|Number
2681554|NCT01391793|Secondary|The Mean Proportion of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan Taken Across the 3 Radiologists|Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For each radiologist, for each child, if either kidney or both kidneys were diagnosed with scarring, then the child was determined to have renal scarring. For each radiologist, the proportion of children with scarring in a given treatment group is the number of children diagnosed with scarring divided by the number of children in the treatment group. The mean proportion of children with scarring in a given treatment group is the average proportion taken across the 3 radiologists.|The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.|The analysis was ITT. The number of participants is equal to the number of children randomized and eligible who had a positive urine culture at enrollment and a DMSA renal scan, of adequate quality, 5-24 months from the time of enrollment.|||proportion of participants with scarring||Standard Deviation|Mean
2681555|NCT01391793|Primary|The Distribution of Children With Severe Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan|Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Scarring was assessed semi-quantitatively by dividing the renal cortex into 12 equal segments. Severe scarring was defined as greater than 4 affected renal segments or global atrophy, i.e. diffuse scarring or shrunken kidney. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For a given kidney, the presence or absence of severe scarring was the diagnosis endorsed by the majority of readers, i.e. 2 of 3. For a given child, if either kidney or both kidneys were diagnosed with severe scarring by the majority of readers, then the child was determined to have severe renal scarring.|The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.|The analysis was ITT. The number of participants is equal to the number of children randomized and eligible who had a positive urine culture at enrollment and a DMSA renal scan, of adequate quality, 5-24 months from the time of enrollment.|||Participants|||Count of Participants
2681556|NCT01391793|Primary|The Distribution of Children With Renal Scarring at the Outcome Dimercaptosuccinic Acid (DMSA) Renal Scan|Renal scarring was defined as decreased uptake of tracer with or without loss of contours. Three radiologists independently reviewed for scarring all DMSA scans that were of adequate quality. For a given kidney, the presence or absence of scarring was the diagnosis endorsed by the majority of readers, i.e. 2 of 3. For a given child, if either kidney or both kidneys were diagnosed with scarring by the majority of readers, then the child was determined to have renal scarring.|The outcome DMSA scan was 5-24 months from enrollment. The mean number of months was 6.1.|The analysis was Intent-to-Treat (ITT). The number of participants is equal to the number of children randomized and eligible who had a positive urine culture at enrollment and a DMSA renal scan, of adequate quality, 5-24 months from the time of enrollment.|||Participants|||Count of Participants
2681557|NCT01391663|Primary|Oral Clearance (CL/F) Pharmacokinetic Parameter|CL/F is apparent clearance of the drug from the plasma after administration of a single dose of the study drug.|Day 1-4|Healthy Korean Participants|||L/hr||Standard Deviation|Mean
2681558|NCT01391663|Primary|Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter|Time required for half of the drug to be eliminated from the plasma after administration of a single dose of the study drug.|Day 1-4|Healthy Korean Participants|||hr||Standard Deviation|Mean
2681559|NCT01391663|Primary|AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter.|Area under the curve from 0 to 24 hours after administrations of a single dose and multiple doses of the study drug.|Day 1-4, Day 10.|Healthy Korean Participants|||ng·hr/mL||Standard Deviation|Mean
2681560|NCT01391663|Primary|AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter|Area under the plasma concentration-time curve from time 0 to infinity after administration of a single dose of the study drug.|Day 1-4|Healthy Korean Participants|||ng·hr/mL||Standard Deviation|Mean
2681561|NCT01391663|Primary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter|Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug|Day 1-4, Day 10.|Healthy Korean Participants|||hr||Full Range|Median
2681562|NCT01391663|Primary|Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter|Maximum observed plasma concentration (Cmax) is the peak plasma concentration after administrations of a single dose and multiple doses of the study drug|Day 1-4, Day 10|Healthy Korean Participants|||ng/mL||Standard Deviation|Mean
2681563|NCT01391611|Secondary|Response Per Choi Criteria|"Response per Choi criteria~Complete response - Disappearance of all lesions; no new lesion~Partial response - A decrease in size of > or = 10% or a decrease in tumor density (HU) > or = 15% on CT. No new lesions. No obvious progression of nonmeasurable disease.~Stable disease - Does not meet the criteria for CR, PR, or PD. No symptomatic deterioration attributed to tumor progression.~Progressive disease - An increase in tumor size of > or = 10% and does not meet criteria of PR by tumor density (HU) on CT. New lesions. New intratumoral nodules or increase in the size of the existing intratumoral nodules."|6 months|Choi criteria measurements were not done due to technical difficulties.||||||
2681564|NCT01391611|Primary|Non-progression Rate Based on RECIST 1.0 Criteria (CR+PR+SD)|"4-mo non-progression rate~Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression"|24 weeks||||months||95% Confidence Interval|Median
2681565|NCT01391559|Primary|Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline at Two Hours After Inhalation of the Study Medication|FEV1|2 hours||||mL||Standard Deviation|Mean
2681592|NCT01391312|Secondary|Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 60|The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 60. Responders were defined as participants with a score of 0=None or 1=Mild.|Day 60|Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point.|||Percentage of participants|||Number
2681566|NCT01391546|Secondary|Percentage of Participants Who Report at Least 1 Serious Adverse Event|"A serious adverse event (SAE) is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement. The percentage of participants who reported an SAE within 35 days of vaccination were recorded."|up to 35 days after vaccination||||Percentage of Participants|||Number
2681567|NCT01391546|Secondary|Percentage of Participants Who Report at Least 1 Systemic Adverse Event|An adverse event (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Adverse events that were considered systemic (not localized) were summarized. These events included rashes of interest: i.e. Varicella, Varicella-like rashes, Herpes zoster or shingles and Herpes zoster-like rashes and other systemic adverse events.|up to Day 28 after vaccination|All vaccinated participants who had follow-up safety data.|||Percentage of Participants||95% Confidence Interval|Number
2681568|NCT01391546|Secondary|Percentage of Participants Who Report at Least 1 Injection-site Adverse Reaction|Participants entered data into daily diary card regarding previously identified possible injection site reactions of erythema, injection site swelling or injection site pain for 1st 4 days post-vaccination. Additionally, injection site reactions not prompted on diary card (unsolicited) were collected up 28 days post-vaccination. All injection site reactions (solicited or unsolicited) were recorded.|up to 28 days after vaccination|All vaccinated participants who had follow-up safety data.|||Percentage of Participants||95% Confidence Interval|Number
2681569|NCT01391546|Secondary|Geometric Mean Fold Rise (GMFR) of IFN-γ ELISPOT Antibodies|Blood samples taken pre-vaccination and 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMFR.|Pre-vaccination (Day 0) and 4 week post-vaccination|All randomised participants in the ELISPOT subset (predetermined protocol-defined sites) who had received the study vaccine and had valid pre- and post-vaccination data for endpoint.|||Ratio||95% Confidence Interval|Geometric Mean
2681570|NCT01391546|Secondary|Geometric Mean Count (GMCs) of VZV Interferon Gamma ((IFN-γ) Enzyme-Linked ImmunoSpot (ELISPOT) Antibodies|Blood samples taken 4 weeks post-vaccination to determine the IFN-γ ELISPOT GMC's. Results were reported as ELISPOT count/10^6 Peripheral Blood Mononuclear Cells (PBMC)|4 week post-vaccination|All randomised participants in the ELISPOT subset (predetermined protocol-defined sites) who had received the study vaccine and had valid post-vaccination data for endpoint.|||ELISPOT count/10^6 PBMC||95% Confidence Interval|Geometric Mean
2681571|NCT01391546|Secondary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: SC Route|Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-vaccination/GMT Pre-vaccination|Pre-vaccination (Day 0) and 4 week post-vaccination|All randomised participants who had received the study vaccine via SC route, had at least one valid immunogenicity evaluation for VZV antibody and had post-vaccination data available for endpoint.|||Ratio||95% Confidence Interval|Geometric Mean
2681572|NCT01391546|Primary|Geometric Mean Fold Rise (GMFR) in VZV Antibody Titre: IM Route|Blood sample taken at predose (Day 0) and 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination|Pre-vaccination (Day 0) and 4 week post-vaccination|All randomised participants who had received the study vaccine via IM route, had at least one valid immunogenicity evaluation for VZV antibody and had post-vaccination data available for endpoint.|||Ratio||95% Confidence Interval|Geometric Mean
2681573|NCT01391546|Primary|Geometric Mean Titre (GMT) of Varicella Zoster Virus (VZV) Antibodies 4 Weeks Post-vaccination|Blood samples taken at 4 weeks post vaccination to determine the geometric mean titre (GMT) of VZV antibodies via Glycoprotein Enzyme Linked Immunosorbent Assay (gpELISA).|4 week post-vaccination|All randomised participants who had received the study vaccine, had at least one valid immunogenicity evaluation for VZV antibody and had post-vaccination data available for endpoint.|||gpELISA units/mL||95% Confidence Interval|Geometric Mean
2681574|NCT01391507|Secondary|Number of Participants With Holter Electrocardiography (ECG) Parameters|A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Block, Heart rhythm, AV junctional, Ventricular, Lown classification, Results were evaluated.|Baseline and Month 6|Safety population included all participants who received at least 1 dose of the study agent.|||Participants|||Number
2681575|NCT01391507|Secondary|Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6|A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Mean heart rate, maximum heart rate and minimum heart rate were evaluated.|Baseline and Month 6|Safety population included all participants who received at least 1 dose of the study agent.|||Beats per minute||Standard Deviation|Mean
2681576|NCT01391507|Secondary|Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6|Minnesota living with heart failure questionnaire is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses participant's perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Participants responded to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Units on a scale||Standard Deviation|Mean
2681593|NCT01391312|Secondary|Percentage of Facial Wrinkle Scale Responders at Maximum Attempted Muscle Contraction at Day 30|The Investigator rated the subject's severity of glabellar lines (between the eyebrows) at maximum attempted muscle contraction using the 4-point Facial Wrinkle scale where 0=None (Best), 1=Mild, 2=Moderate, 3=Severe (Worse) at day 30. Responders were defined as participants with a score of 0=None or 1=Mild.|Day 30|Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point.|||Percentage of participants|||Number
2682914|NCT01380093|Secondary|Maximum Observed Plasma Concentration (Cmax) of Naltrexone Metabolite (6-beta-naltrexol)||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||pg/mL||Standard Deviation|Mean
2681577|NCT01391507|Secondary|Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression|Disease progression (morbidity) was measured by the NYHA classification. The NYHA classification assesses the severity of symptoms of heart failure as judged by the investigator and is comprised of 4 stages. Stage I- No symptoms/limitation in ordinary physical activity (for example, shortness of breath when walking, climbing stairs); Stage II-Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Stage III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity, (for example, walking short distances [20-100 m]), comfortable only at rest; and Stage IV- Severe limitations in activity/experiences symptoms while at rest (mostly bedbound participants).|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here ‘n’ specifies those participants who were evaluated for this outcome measure at given time point.|||Participants|||Number
2681578|NCT01391507|Secondary|Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6|A standardized 6-minute walk test was performed and the distance covered in 6 minutes was measured.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method.|||Meter||Standard Deviation|Mean
2681579|NCT01391507|Secondary|Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6|Tissue doppler mitral annular velocity is a measure of how well the heart fills with blood. This was measured by echocardiogram. Most of the values for E-wave were not provided in the reports from central core echocardiographic laboratory due to technical reasons.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.|||Centimeter (cm)/ Second (sec)||Standard Deviation|Mean
2681580|NCT01391507|Secondary|Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6|Transmitral flow VTI measures how blood flows through the heart. This was measured by echocardiogram. Most of the values for transmitral flow VTI were not provided in the reports from central core echocardiographic laboratory due to technical reasons.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, “N” (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. No participants were evaluable for arms COR-1 80 mg and COR-1 160 mg.|||Centimeter (cm)||Standard Deviation|Mean
2681581|NCT01391507|Secondary|Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6|The NT-ProBNP is a biomarker (a biologic molecule) that has been shown to predict cardiac events.|Baseline and Month 6|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method.|||Picogram (pg)/ Milliliter (mL)||Standard Deviation|Mean
2681582|NCT01391507|Secondary|Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9|The LVEF is a measure of how much blood is pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (>) 55% are considered normal. It was measured by biplane echocardiography (local assessment).|Baseline and Month 9|ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method.|||Percentage of blood pumped out||Standard Deviation|Mean
2681583|NCT01391507|Primary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6|The LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (>) 55% are considered normal. It was measured by biplane echocardiography (central assessment).|Baseline and Month 6|Intention-to-treat (ITT) population included all participants who were randomly assigned to treatment. Missing data was imputed using last observation carried forward (LOCF) method.|||Percentage of blood pumped out||Standard Deviation|Mean
2681584|NCT01391468|Post-Hoc|Change of Serum IL-10 Level at 6 Months|IL-10 is an anti-inflammatory cytokine; The change of serum IL-10 level at 6 months was measured|6 months||||pg/ml||Standard Deviation|Mean
2681585|NCT01391468|Post-Hoc|Change of Serum Endotoxin Level at 6 Months|endotoxin is a marker of inflammation in chronic kidney disease patients|6 months follow-up||||EU/ml||Standard Deviation|Mean
2681586|NCT01391468|Secondary|Change of Gastrointestinal Symptoms at 6 Months|The change in gastrointestinal symptom rating scale (min and maximum scores 0-45) after treatment. The total score is reported. The higher scale represents a worse outcome.|6 months follow-up||||units on a scale||Standard Deviation|Mean
2681587|NCT01391468|Primary|the Occurrence of Cardiovascular Event and Peritonitis Events||6 month follow-up||||participants|||Number
2681588|NCT01391325|Secondary|Mean Change From Baseline to Month 6 in SF-36 PCS+MCS|The SF-36 is a short-form health survey with 36 questions that yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical (PCS) and mental health (MCS) summary. Each scale is directly transformed into a 0-100 scale. The lower the score the more disability. The higher the score the less disability. The component scores (PCS and MCS) are norm-based to a standard population with a mean of 50 and a standard deviation of 10.|Month 6|Subjects who recieved at least one dose of allopurinol|||units on a scale||Standard Deviation|Mean
2681589|NCT01391325|Secondary|Incidence of Gout Flares|Proportion of subjects who experienced at least one gout flare requiring treatment during the study.|Every month for 6 months.|Subjects who received at least one dose of allopurinol|||percentage of subjects||95% Confidence Interval|Number
2681590|NCT01391325|Secondary|Proportion of Subjects With Serum Urate (sUA) Less Than 6.0 mg/dL|Proportion of subjects with serum urate (sUA) less than 6.0 mg/dL at Month 6 using Last Observation Carried Forward (LOCF) for subjects with missing values at Month 6.|Month 6|All subjects who received at least one dose of allopurinol|||percentage of subjects||95% Confidence Interval|Number
2681591|NCT01391325|Primary|Safety of Allopurinol|Proportion of subjects who experienced at least one Treatment Emergent Adverse Event (TEAE) during the study.|Every month for 6 months.|All subjects who received at least one dose of allopurinol|||percentage of subjects|||Number
2682915|NCT01380093|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone Metabolite (6-beta-naltrexol)||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs||Standard Deviation|Mean
2681594|NCT01391312|Primary|Percentage of Participants With Improvement in Subject Global Assessment of Change at Day 30|Subjects assessed the improvement of their glabellar lines (area between the eyebrows) by answering the question: Compared to before receiving the study treatment, How do you currently feel about the appearance of your glabellar lines? on a 7-point scale where 0=Very much improved, 1=Much improved, 2=Minimally improved, 3=No change, 4=Minimally worse, 5=Much worse, 6=Very much worse. Improvement was defined as responses: 0=Very much improved, 1=Much improved and 2=Minimally improved.|Day 30|Participants from the Intent-to-treat population (all randomized participants) with data available for the time-point.|||Percentage of participants|||Number
2681595|NCT01391299|Secondary|Percentage of Participants With a ≥1 Grade Improvement From Baseline by Subject-Assessed FWS in Forehead Lines at Rest|Participants assessed the severity of their forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline.|Baseline, Day 30|Participants from the intent-to-treat population (all randomized participants) with a Facial Wrinkle Score of at least mild at baseline.|||Percentage of participants|||Number
2681596|NCT01391299|Secondary|Percentage of Participants With a ≥1 Grade Improvement From Baseline by Investigator-Assessed FWS in Forehead Lines at Rest|The Investigator assessed the severity of the patient's forehead lines at rest using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a ≥1 grade improvement from baseline.|Baseline, Day 30|Participants from the intent-to-treat population (all randomized participants) with a Facial Wrinkle Score of at least mild at baseline.|||Percentage of participants|||Number
2681597|NCT01391299|Secondary|Percentage of Participants Achieving Satisfied or Very Satisfied by Subject Assessment of Satisfaction of Appearance of Forehead Lines|Participants rated their overall satisfaction with the appearance of the forehead line area using a 5-point scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied or 5=very satisfied. The percentage of participants with a rating of satisfied or very satisfied at Day 30.|Day 30|Includes participants from the Intent-to-treat Population (all randomized participants) with a rating of very unsatisfied, unsatisfied or neutral in the Subject's Assessment of Satisfaction of Appearance at baseline.|||Percentage of participants|||Number
2681598|NCT01391299|Primary|Percentage of Participants Achieving a Score of None or Mild by Subject-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation|The patient assessed the severity of their forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30.|Day 30|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
2681599|NCT01391299|Primary|Percentage of Participants Achieving a Score of None or Mild by Investigator-Assessed Facial Wrinkle Scale With Photonumeric Guide (FWS) in Forehead Lines at Maximum Eyebrow Elevation|The Investigator assessed the severity of the patient's forehead lines at maximum eyebrow elevation using the 4-point FWS: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30.|Day 30|Intent-to-treat population included all randomized participants.|||Percentage of participants|||Number
2681600|NCT01391286|Secondary|Change From Baseline in Eyelash Darkness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.|||Units on a scale||Full Range|Median
2681601|NCT01391286|Secondary|Change From Baseline in Eyelash Thickness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.|||mm^2||Full Range|Median
2681602|NCT01391286|Secondary|Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.|||mm||Full Range|Median
2681603|NCT01391286|Primary|Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)|The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.|Baseline, Month 4|Intent to treat population included all randomized participants.|||Percentage of participants|||Number
2681604|NCT01391273|Secondary|Change From Baseline in Eyelash Darkness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.|||Units on a scale||Standard Deviation|Mean
2681605|NCT01391273|Secondary|Change From Baseline in Eyelash Thickness as Measured by DIA|Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).|Baseline, Month 4|Participants from the Intent to treat population with data available for analysis.|||mm^2||Standard Deviation|Mean
2681606|NCT01391273|Secondary|Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)|Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).|Baseline, Month 4|Intent to treat population included all randomized participants.|||mm||Standard Deviation|Mean
2681691|NCT01390649|Primary|Set of Antibodies Most Frequently Bound to Red Blood Cells (RBCs) in Subjects Experiencing Clinically Significant Intravascular Hemolysis|The occurrence of clinically significant intravascular hemolysis was determined by an independent Adjudication Committee. No subject experienced clinically significant intravascular hemolysis; therefore, the primary safety endpoint could not be analyzed.|Within 3 days of infusion|||||||
2681608|NCT01391130|Secondary|Duration of Complete Response|Duration of complete response is defined as the time from the date when the measurement criteria are met for complete response until the date of first observation of objective disease progression (taking as reference for PD the smallest measurements recorded since the treatment started). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. Progressive Disease (PD)is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|Date of Complete Response to the Date of Progressive Disease (Up to 67 Months)|All participants who received at least one dose of study drug who had CR.|||months||95% Confidence Interval|Median
2681609|NCT01391130|Secondary|Duration of Overall Response (DOR)|DOR was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.|Date of First Response to Date of Progressive Disease (Up to 67 Months)|All participants who received at least one dose of study drug. Participants censored were LY2510924 + Sunitinib=7 and Sunitinib=7.|||Months||95% Confidence Interval|Median
2681610|NCT01391130|Secondary|Overall Survival (OS)|OS is defined as the time from the date of study randomization to the date of death from any cause. For participants who were still alive as of the data cut-off date, OS time will be censored on the date of the participant's last contact (last contact for participants in post-discontinuation = last known alive date in mortality status).|Randomization to Date of Death from Any Cause (Up to 67 Months)|All participants who received at least one dose of study drug. Participants censored were LY2510924 + Sunitinib=19 and Sunitinib=10.|||months||95% Confidence Interval|Median
2681611|NCT01391130|Secondary|Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])|ORR is defined as the number of participants with a best response of CR and PR defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PR is defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions is also considered progression.|Baseline to Date of Tumor Response or Measured Progressive Disease or Date of Death from any Cause ((Up to 67 Months)|All participants who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2681612|NCT01391130|Primary|Progression Free Survival (PFS)|PFS is defined as the time from date of study Randomization to the first date of objectively determined progressive disease(PD) or death from any cause defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0).PD was defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study(including the baseline sum if that is the smallest).In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance of one or more new lesions was also considered PD.For participants still alive at the time of analysis and without evidence of tumor progression,PFS would be censored at the date of the most recent objective progression-free observation.For participants who receive subsequent anticancer therapy prior to objective disease progression or death,PFS was censored at the date of the last objective progression-free observation prior to the date of subsequent therapy.|Randomization to Measured Progressive Disease or Date of Death From Any Cause (Up to 67 Months)|All participants who received at least one dose of study drug. Participants censored were LY2510924 + Sunitinib = 16 and Sunitinib=12.|||Months||95% Confidence Interval|Median
2681613|NCT01391013|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Count Over Week 48||Screening (Week -4), Week 1 (Day 1), Week 4, Week 12, Week 24, Week 36, Week 48, and follow-up (Week 52)|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||CD4 cells||Inter-Quartile Range|Median
2681614|NCT01391013|Secondary|Change From Baseline to Week 48 in Lumbar Z Score: Median Change in Lumbar Z Score|Z score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. Z score is the number of standard deviations above or below the mean for the participant's age, sex and ethnicity. This score is calculated from participant's age, gender and race and skeletal site. Z score has a mean of '0' and a standard deviation of '1'. Z score lower than its mean indicate low bone mineral density.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||Z score||Inter-Quartile Range|Median
2681615|NCT01391013|Secondary|Change From Baseline to Week 48 in Lumbar T Score: Median Change in Lumbar T Score|T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of '50' and a standard deviation of '10'. T score lower than its mean indicate low bone mineral density.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||T score||Inter-Quartile Range|Median
2684378|NCT01368497|Secondary|Proportion of Participants With HBV DNA < 20 IU/mL||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
2681616|NCT01391013|Secondary|Change From Baseline to Week 48 in Femoral Neck Z Score: Median Change in Femoral Neck Z Score|Z score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. Z score is the number of standard deviations above or below the mean for the participant's age, sex and ethnicity. This score is calculated from participant's age, gender and race and skeletal site. Z score has a mean of '0' and a standard deviation of '1'. Z score lower than its mean indicate low bone mineral density.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||Z score||Inter-Quartile Range|Median
2681617|NCT01391013|Secondary|Change From Baseline to Week 48 in Femoral Neck T Score: Median Change in Femoral Neck T Score|T score is used to calculate bone mineral density (calcium and other types of minerals) in an area of the bone. T score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as a participant. This score is calculated from participant's age, gender and race and skeletal site. T score has a mean of '50' and a standard deviation of '10'. T score lower than its mean indicate low bone mineral density.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||T score||Inter-Quartile Range|Median
2681618|NCT01391013|Secondary|Change From Baseline to Week 48 in Visceral Fat Content in Abdomen: Median Change in Visceral Abdominal Tissue (VAT)|Visceral fat content in abdomen will be analyzed with median change in VAT by an abdomen Computerized Tomography.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||cm square||Inter-Quartile Range|Median
2681619|NCT01391013|Secondary|Change From Baseline to Week 48 in Leg Fat Content: Median Change in Leg Fat (Total)|Leg fat content will be analyzed by Dual Energy X-ray Absortiometry (DEXA scan).|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||Percentage of fat||Inter-Quartile Range|Median
2681620|NCT01391013|Secondary|Change From Baseline in Mean Framingham Risk Score at Week 24 and Week 48: Medican Change in Framingham Risk Score|The Framingham Risk Score is used to estimate the 10-year cardiovascular risk of a participant. It is calculated according to age, laboratory values of total cholesterol and HDL cholesterol, smoking status, and systolic blood pressure. The framingham risk score is calculated as: for males: 0 point (1 percentage) up to 17 points (30 percentages); whereas for females: 0 to 9 points (1 percentage) up to 25 points (30 percentage). Higher scores indicate high cardiovascular risk.|Baseline, Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||Framingham risk score||Inter-Quartile Range|Median
2681621|NCT01391013|Secondary|Change From Baseline in Insulin Sensitivity at Week 24 and Week 48: Median Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|The Homeostatic Model Assessment (HOMA) is a method used to quantify insulin resistance and beta-cell function. HOMA-IR is reflected in the diminished effect of insulin on hepatic glucose production. HOMA-IR is calculated as: (Glucose [mg/dL] X Insulin [pmol/L]) / (405 X 6.945). Higher scores indicate worse insulin resistance.|Baseline, Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||HOMA score||Inter-Quartile Range|Median
2681622|NCT01391013|Secondary|Change From Baseline in Mean Triglycerides at Week 24 and Week 48: Median Change in Triglycerides||Baseline, Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||mg/dL||Inter-Quartile Range|Median
2681623|NCT01391013|Secondary|Change From Baseline in Mean High-density Lipoprotein (HDL) Cholesterol at Week 24 and Week 48: Median Change in HDL||Baseline, Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||mg/dL||Inter-Quartile Range|Median
2681624|NCT01391013|Secondary|Change From Baseline in Mean Low-density Lipoprotein (LDL) Cholesterol at Week 24 and Week 48: Median Change in LDL||Baseline (Day1 of Week 1), Week 24, and Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||mg/dL||Inter-Quartile Range|Median
2681625|NCT01391013|Secondary|Change From Baseline to Week 48 in Precursors of Circulating Endothelial Cells||Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||Endothelial cells||Full Range|Median
2681626|NCT01391013|Secondary|Change From Baseline to Week 48 in Circulating Endothelial Cells||Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||Endothelial cells||Full Range|Median
2681627|NCT01391013|Secondary|Number of Participants With a Human Immunodeficiency Virus- Ribonucleic Acid (HIV-RNA) Greater Than or Equal to 50 Copies/mL||Screening (Week -4), Week 1 (Day 1), Week 4, Week 12, Week 24, Week 36, Week 48, and follow-up (Week 52)|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||Participants|||Number
2681628|NCT01391013|Secondary|Change From Baseline to Week 48 in Brachial Artery FMD: Median Change in FMD (%)|Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter.|Baseline to Week 48|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||Percentage of brachial artery diameter||Inter-Quartile Range|Median
2681629|NCT01391013|Primary|Change From Baseline to Week 24 in Brachial Artery Flow Mediated Vasodilatation (FMD): Median Change in FMD (%)|Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia (an increase in the quantity of blood flow to a body part) induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter.|Baseline (Day 1 of Week 1) to Week 24|Participants who were randomized, who received the study medication, and who contributed any efficacy data after the start of study treatment.|||Percentage of brachial artery diameter||Inter-Quartile Range|Median
2693593|NCT01294163|Secondary|Haemodynamic Profile|Monitoring of heart rate, arterial blood pressure, central venous pressure.|4 hours|||||||
2681630|NCT01391000|Secondary|Short Form 12-PCS for Quality of Life Assessment|The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. SF-12 score measures substantially limited physical disability, general well-being and the perception of one's state of health, (Physical Component Summary) and also measure the psychological attitude of the patient, the limitation in social and personal activities (Mental Component Summary). Physical and Mental Health Composite Scores are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.|Change from baseline in quality of life at the end of the rehabilitation cycle (two weeks)||||units on a scale||95% Confidence Interval|Mean
2681631|NCT01391000|Secondary|Constant Murley Score for Range of Motion and Shoulder Function Assessment.|The Constant Murley scale had values from 0 to 100 where zero represented the worst possible range of motion and shoulder function and 100 the best.|Change from baseline in range of motion at the end of the rehabilitation cycle (two weeks)||||units on a scale||95% Confidence Interval|Mean
2681632|NCT01391000|Primary|Visual Analogue Scale Mean Score|To evaluate the analgesic efficacy of Light Amplification by Stimulated Emission of Radiation carbon dioxide therapy vs Transcutaneous Electrical Nerve Stimulator during the first cycle of rehabilitation through Visual Analogue Scale, calculating the mean score in values of beginning and end of daily treatment. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain.|Change from baseline in pain at the end of the rehabilitation cycle (two weeks)||||units on a scale||95% Confidence Interval|Mean
2681633|NCT01390948|Secondary|Percentage of Participants With an Adverse Event (AE)|An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months)|Safety population included all participants that received study drug.|||percentage of participants|||Number
2681634|NCT01390948|Secondary|Number of Dose Administrations of Study Treatment in the Concurrent Phase|Number of doses were assessed for the concurrent phase, which is the treatment period after the initial treatment phase and including the subsequent treatment break of approximately 4 weeks.|Beginning of the concurrent phase to end of treatment break (10 weeks)|Safety population included all participants that received study drug.|||number of dose administrations||Full Range|Median
2681635|NCT01390948|Secondary|Percentage of Participants With a Treatment Delay or Discontinuation||From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months)|Randomized participant population included all randomized participants regardless of whether they received study treatment.|||percentage of participants|||Number
2681636|NCT01390948|Secondary|Percentage of Participants Who Completed >/= 90% of Planned Radiotherapy and TMZ Administrations||From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months)|Safety population included all participants that received study treatment.|||percentage of participants|||Number
2681637|NCT01390948|Secondary|Neurological Psychological Function as Measured by the Wechsler Scale|The Wechsler Intelligence Scale for Children version IV (WISC-IV) was used to generate a full scale intelligence quotient (IQ) which represents a child's general intellectual ability. The average IQ score is 100, with lower scores representing lower intellectual ability.|End of treatment (approximately 58 weeks post-baseline)|Randomized participant population included all randomized participants regardless of whether they received study treatment.|||units on a scale||Standard Deviation|Mean
2681638|NCT01390948|Secondary|Health Status as Measured by the Health Utility Index (HUI)|HUI is a preference-based, multi-attitude, health-related instrument specifically developed for use with children. HUI consists of eight attributes of health status: vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. Each attribute had 5 or 6 levels varying from highly impaired to normal. Each of the eight health dimensions was tested separately and a composite score ranging between 1 (perfect health) and 0 (death) was obtained for participants aged 5 years or older.|Baseline, Cycle 6 of the adjuvant phase, end of treatment (approximately 58 weeks post-baseline), and yearly during the follow-up period (maximum 5 years in follow-up)|Randomized participant population aged 5 years or older with a measure at the specified time point. Here, 'n' represents the number of participants with a measure at the specified time point.|||units on a scale||Standard Deviation|Mean
2681639|NCT01390948|Secondary|Concordance Between Structural Versus Multimodal Imaging for CRRC-Assessed Event-Free Survival|Concordance is presented as the percentage of participants with concordance between assessments. EFS concordance was defined as event Structural assessment and Diffusion Perfusion assessment occurs within 28 days or no event Structural and no Diffusion Perfusion.|From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months)|Randomized participant population included all randomized participants regardless of whether they received study treatment.|||percentage of participants|||Number
2681640|NCT01390948|Secondary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) determined on two consecutive occasions >/= 4 weeks apart. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. The following were needed to qualify as CR: complete disappearance of all measurable enhancing lesions sustained for at least 4 weeks by MRI, no steroids above physiological levels, clinical status stable or improved compared to baseline. The following were needed to qualify as PR: ≥ 50% decrease from baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks by MRI, steroid dose not increased compared to baseline, clinical status stable or improved compared to baseline.|From the time of randomization of the first participant to the date of clinical cutoff (approximately 52 months)|Randomized participant population with a measurable lesion at baseline.|||percentage of participants||95% Confidence Interval|Number
2681651|NCT01390857|Secondary|Number of Participants With the Indicated Adverse Drug Reactions|"An adverse drug reaction (ADR) is an adverse event whose causal relationship to study drug was not ruled out by the reporting physician. An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all ADRs occurring during the course of the study, please also see the table entitled Other (non-serious) adverse events in the Adverse Event section of the results record."|1 month|ITT Safety Population|||participants|||Number
2681641|NCT01390948|Secondary|EFS as Assessed by the Investigator|EFS was defined as the time from diagnosis to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non-HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the investigator using RANO criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the participant on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.|From the time of randomization to the date of any defined event (up to approximately 52 months)|Randomized participant population included all randomized participants regardless of whether they received study treatment.|||months||95% Confidence Interval|Median
2681642|NCT01390948|Secondary|Percentage of Participants With EFS as Determined by the CRRC at 1 Year|EFS was defined as the time from diagnosis to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the participant on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.|1 year|Randomized participant population included all randomized participants regardless of whether they received study treatment.|||percentage of participants||95% Confidence Interval|Number
2681643|NCT01390948|Secondary|Percentage of Participants With EFS as Determined by the CRRC at 6 Months|EFS was defined as the time from diagnosis to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the participant on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.|6 months|Randomized participant population included all randomized participants regardless of whether they received study treatment.|||percentage of participants||95% Confidence Interval|Number
2681644|NCT01390948|Secondary|Percentage of Participants With 1-Year Survival|1-year survival was estimated using the Kaplan-Meier method.|1 year|Randomized participant population included all randomized participants regardless of whether they received study treatment.|||percentage of participants||95% Confidence Interval|Number
2681645|NCT01390948|Secondary|Overall Survival|Overall Survival was defined as the time of diagnosis to the date of death due to any cause. Overall Survival was estimated using the Kaplan-Meier method.|From the time of randomization to the date of death (up to approximately 52 months)|Randomized participant population included all randomized participants regardless of whether they received study treatment.|||months||95% Confidence Interval|Median
2681646|NCT01390948|Primary|Event-Free Survival (EFS) as Assessed by the Central Radiology Review Committee (CRRC)|EFS was defined as the time from diagnosis to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non-high-grade glioma (HGG) malignancy or death attributable to any cause. Tumor assessments were conducted using magnetic resonance imaging (MRI) and reviewed by the site-independent CRRC using Response Assessment in Neuro-Oncology (RANO) criteria. Tumor progression was defined as clear clinical progression or a greater than or equal to (>/=) 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the participant on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.|From the time of randomization to the date of any defined event (up to approximately 52 months)|Randomized participant population included all randomized participants regardless of whether they received study treatment.|||months||95% Confidence Interval|Median
2681647|NCT01390909|Primary|Average Annualized Costs|Average annualized overall healthcare costs and epilepsy-related healthcare costs were calculated for each treatment group. Epilepsy-related costs were those with a code for epilepsy. ED, Emergency Department; AMC, All Medical Costs; Ep Rel, Epilepsy Related. United States dollars were consumer price index adjusted for 2009.|1 year|For Arms 1 - 4, Medicaid-enrolled participants with uncontrolled epilepsy (see Arm Descriptions for Arm Title 1 and Arm Title 3) or matched participants with well-controlled or intermediate epilepsy. For Arms 5 - 8, privately-insured participants with uncontrolled epilepsy or matched participants with well-controlled or intermediate epilepsy.|||United States dollars||Standard Deviation|Mean
2681648|NCT01390870|Primary|Number of Participants Reporting Compliance With Medication|"Compliance was calculated based on the participant's response to the following question: In general, how many times did you miss taking your prostate medication? Responses were measured on a 5-point scale. Participants who answered I never miss a dose of my medication were considered compliant. All other responses were considered non-compliant."|Cross sectional survey administered once to each participant during a 17-month study period (May 2009 to September 2010)|All enrolled participants taking 5-alpha reductase inhibitors and/or alpha blockers|||participants|||Number
2681649|NCT01390857|Secondary|Number of Participants Classified as Effective and Not Effective|"The course of symptoms was comprehensively assessed by the investigator on a four-category scale (Improved, Unchanged, Worsen, and Unassessable) before and after the initiation of valaciclovir therapy. Improved was regarded as Effective, and Unchanged and  Worsen were regarded as Not effective. The two participants classifed as Not effective were classified as Unchanged."|1 month|Efficacy Analysis Set: all participants assessed for efficacy who completed all study visits; 7 participants did not undergo an efficacy evaluation, and 13 participants failed to visit after the first visit.|||participants|||Number
2681652|NCT01390857|Primary|Number of Participants With Any Serious Adverse Event|"A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all serious adverse events occurring during the course of the study, please see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|1 month|Intent-to-Treat Safety Population: all participants to whom the drug was administered, excluding 10 withdrawal participants.|||participants|||Number
2681653|NCT01390844|Secondary|Percentage of Participants With an AE of Neutropenia in India|Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant.|Up to 96 weeks|APaT - population consists of all randomized participants in India who received ≥ 1 dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included; participants who did not demonstrate GCP compliance were excluded from analysis.|||Percentage of Participants|||Number
2681654|NCT01390844|Secondary|Percentage of Participants With an AE of Neutropenia in Korea and Taiwan|Neutropenia is an abnormally low level of white blood cells (neutrophils). This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 neutropenia during the treatment phase. A higher grade indicates a higher degree of neutropenia. This table summarizes the worst category observed within the period for each participant.|Up to 96 weeks|APaT - population consists of all randomized participants in Korea and Taiwan who received at least one dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included.|||Percentage of Participants|||Number
2681655|NCT01390844|Secondary|Percentage of Participants With an AE of Anemia in India|Anemia is a condition in which the number of red blood cells (hemoglobin) is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified WHO grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters).|Up to 96 weeks|APaT - population consists of all randomized participants in India who received ≥ 1 dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included; participants who did not demonstrate GCP compliance were excluded from analysis.|||Percentage of Participants|||Number
2681656|NCT01390844|Secondary|Percentage of Participants With an Adverse Event (AE) of Anemia in Korea and Taiwan|Anemia is a condition in which the number of red blood cells or hemoglobin concentration is insufficient to meet the body's physiologic needs. This measure gives the percentage of participants who experienced an occurrence of modified World Health Organization (WHO) grade 1-4 anemia during the treatment period. A higher grade indicates a higher degree of anemia. This table summarizes the worst category observed within the period per participant per laboratory test (i.e., the lowest value for the hemotologic parameters).|Up to 96 weeks|All Participants as Treated (APaT) - population consists of all randomized participants in Korea and Taiwan who received at least one dose of study treatment, corresponding to the study treatment they actually received. Only participants with at least one treatment value for a given laboratory test are included.|||Percentage of Participants|||Number
2681657|NCT01390844|Secondary|Percentage of Participants in India Achieving EVR at Treatment Week 8|Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8)|Treatment Week 8|FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC); participants who did not demonstrate GCP compliance were excluded from analysis.|||Percentage of Participants|||Number
2681658|NCT01390844|Secondary|Percentage of Participants in Korea and Taiwan Achieving Early Virologic Response (EVR) at Treatment Week 8|Percentage of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8)|Treatment Week 8|FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC).|||Percentage of Participants|||Number
2681659|NCT01390844|Secondary|Percentage of Participants in India With SVR at Follow-Up Week 24 - mITT Population|SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.|Follow-up Week 24|mITT - population includes all randomized participants who received at least one (1) dose of experimental study drug (i.e., BOC for the Experimental Arm or placebo for the Control Arm); participants who did not demonstrate GCP compliance were excluded from analysis.|||Percentage of Participants|||Number
2681660|NCT01390844|Secondary|Percentage of Participants in Korea and Taiwan With SVR at Follow-Up Week 24 - Modified Intent-to-Treat (mITT) Population|SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.|Follow-up Week 24|mITT - population includes all randomized participants who received at least one (1) dose of experimental study drug (i.e., BOC for the Experimental Arm or placebo for the Control Arm).|||Percentage of Participants|||Number
2681661|NCT01390844|Primary|Percentage of Participants in India With SVR at Follow-Up Week 24 - FAS Population|SVR is defined as undetectable plasma HCV-RNA at FW24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The LOCF method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.|Follow-up Week 24|FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC); participants who did not demonstrate GCP compliance were excluded from analysis.|||Percentage of Participants|||Number
2681662|NCT01390844|Primary|Percentage of Participants in Korea and Taiwan With Sustained Virologic Response (SVR) at Follow-Up Week 24 - Full Analysis Set (FAS) Population|SVR is defined as undetectable plasma HCV-RNA at Follow-up Week (FW) 24. If FW24 is missing and other HCV-RNA values after FW24 are available, the last available value would be used for FW24. The last observation carried forward (LOCF) method was used to impute missing values; if a participant is missing at and after FW24 and has FW12 data, then FW12 data will be carried forward to FW24. Cross-over participants are considered as non-responders in SVR.|Follow-up Week 24|FAS - population includes all randomized participants who received at least one (1) dose of any study medication (i.e., PEG, RBV, or BOC).|||Percentage of Participants|||Number
2681663|NCT01390818|Secondary|Number of Subjects With Complete Tumor Response (CR), Partial Tumor Response (PR), or Stable Disease (SD)|CR=Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR=At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD= At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|From the date of randomisation every 6 weeks up to assessed up to 4 years|The Efficacy Analysis Set (EEF) included all subjects who received at least 1 trial treatment dose (Pimasertib or SAR245409) and had radiographic baseline and at least one evaluable post baseline tumor assessment.|||subjects|||Number
2681664|NCT01390818|Secondary|pERK Concentrations in PBMCs|"pERK Concentrations in PBMCs was measured during DDI Evaluation period and Cycle 1 for DE cohorts. DDI evaluation period is a 4-day period that was performed within 1 week prior to Day 1 Cycle 1. In DDI evaluation period, On Day 1, SAR245409 was be administered alone, and on Day 3, Pimasertib was administered alone. No data were planned to be collected for Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily, Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily, Pimasertib (MSC1936369) 30mg and SAR245409 70mg Once Daily and Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily reporting arms."|DDI Evaluation: Day 1 and 3 (predose, 2, 4, 8 and 24 hours (hr) postdose); Day 2 and 4 (24 hr postdose); C1D1 and C1D15 (predose, 2, 4, 8, 24 hr postdose); C1D2 and C1D16 (24 hr postdose); C1D19 (predose, 2 hr postdose)|Biomarker Analysis Set for pharmacodynamics marker analysis in PBMC included all subjects who received at least first dose of both drugs and had provided at least one pre-dose sample and one post-dose sample. Here “N” signifies number of subject analysed for this outcome measure” and “n” signifies number of subject analysed at specific time point.|||fluorescence intensity||Standard Deviation|Mean
2681665|NCT01390818|Secondary|pS6 Concentrations in Peripheral Blood Mononuclear Cells (PBMCs)|"pS6 Concentrations in PBMCs was measured during DDI Evaluation period and Cycle 1 for DE cohorts. DDI evaluation period is a 4-day period that was performed within 1 week prior to Day 1 Cycle 1. In DDI evaluation period, On Day 1, SAR245409 was be administered alone, and on Day 3, Pimasertib was administered alone. No data were planned to be collected for Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily, Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily, Pimasertib (MSC1936369) 30mg and SAR245409 70mg Once Daily and Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily reporting arms."|DDI Evaluation: Day 1 and 3 (predose, 2, 4, 8 and 24 hours (hr) postdose); Day 2 and 4 (24 hr postdose); Cycle 1 Day 1 (C1D1) and C1D15 (predose, 2, 4, 8, 24 hr postdose); C1D2 and C1D16 (24 hr postdose); C1D19 (predose, 2 hr postdose)|The Biomarker Analysis Set for pharmacodynamics (PD) marker analysis in PBMC included all subjects who received at least the first dose of both drugs and had provided at least one pre-dose sample and one post-dose sample. Here “n” signifies the number of subjects evaluable at the specific time points.|||fluorescence intensity||Standard Deviation|Mean
2681666|NCT01390818|Secondary|Accumulation Ratio (Racc) for Cmax of SAR245409: Day 15|Accumulation ratio (Racc) for Cmax, calculated as Day 15 Cmax divided by Day 1 Cmax.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here N signifies number of participant analyzed for this outcome measure and “n” signifies the number of subjects evaluable at the specific time points."|||Ratio||95% Confidence Interval|Geometric Mean
2681667|NCT01390818|Secondary|Accumulation Ratio (Racc) for AUCtau of SAR245409: Day 15|Accumulation ratio (Racc) for AUCtau, calculated as Day 15 dosing interval AUCtau divided by Day 1 dosing interval AUCtau.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here N signifies number of participant analyzed for this outcome measure and “n” signifies the number of subjects evaluable at the specific time points."|||ratio||95% Confidence Interval|Geometric Mean
2681668|NCT01390818|Secondary|Apparent Volume of Distribution of Total SAR245409 During the Terminal Phase Following Oral Administration (Vz/f)|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Apparent volume of distribution during the terminal phase, calculated by CL/f/λz. Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||litre||95% Confidence Interval|Geometric Mean
2681669|NCT01390818|Secondary|Total Body Clearance (CL/f) of SAR245409|The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the dose with area under the plasma concentration time curve from time zero to infinity (AUC 0-inf)=Dose/AUC 0-inf.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||litre per hour||95% Confidence Interval|Geometric Mean
2681671|NCT01390818|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Infinity (0-inf) of SAR245409: Day 1|"Area under the concentration-time curve from time 0 extrapolated to infinity, calculated as AUC0-t + last observed concentration (Clast)/terminal rate constant (λz), using the Linear up/Log down method.~Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale."|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1 for DE cohorts|"The PK analysis set. Here N signifies number of subjects evaluable for this outcome measure and “n” signifies the number of subjects evaluable at the specific time points."|||hr*ng/mL||95% Confidence Interval|Geometric Mean
2681672|NCT01390818|Secondary|Area Under the Concentration-Time Curve (AUC) During a Dosing Interval (Tau) of SAR245409||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||hr*ng/mL||95% Confidence Interval|Geometric Mean
2681673|NCT01390818|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of SAR245409|Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time (0-24 hours) at which the concentration is at or above the lower limit of quantification. Unit of assessment was hour*nanogram per milliliter (hr*ng/mL).|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||hr*ng/mL||95% Confidence Interval|Geometric Mean
2681674|NCT01390818|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of SAR245409|The time to reach maximum plasma concentration (Tmax) of SAR245409 was calculated.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||hours||Full Range|Median
2681675|NCT01390818|Secondary|Maximum Observed Plasma Concentration (Cmax) for SAR245409||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||nanogram per millilitre (ng/mL)||95% Confidence Interval|Geometric Mean
2681676|NCT01390818|Secondary|Accumulation Ratio (Racc) for Cmax of Pimasertib (MSC1936369B): Day 15|Accumulation ratio (Racc) for Cmax, calculated as Day 15 Cmax/Day 1 Cmax.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here N signifies number of subjects evaluable for this outcome measure and “n” signifies the number of subjects evaluable at the specific time points."|||ratio||95% Confidence Interval|Geometric Mean
2681677|NCT01390818|Secondary|Accumulation Ratio (Racc) for AUCtau of Pimasertib (MSC1936369B): Day 15|Accumulation ratio (Racc) for AUCtau, calculated as Day 15 dosing interval AUCtau per Day 1 dosing interval AUCtau.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here N signifies number of subjects evaluable for this outcome measure and “n” signifies the number of subjects evaluable at the specific time points."|||ratio||95% Confidence Interval|Geometric Mean
2681678|NCT01390818|Secondary|Apparent Volume of Distribution of Total Pimasertib During the Terminal Phase Following Oral Administration (Vz/f) of Pimasertib|Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Apparent volume of distribution during the terminal phase, calculated by CL/f/λz. Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale.Data was not available for 'Pimasertib (MSC1936369B) 60mg Twice Daily' arm as no subjects were considered evaluable because of limited number of samples collected to characterize the terminal phase rate constant needed for the calculation of Vz/f.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here N signifies number of subjects evaluable for this outcome measure and “n” signifies the number of subjects evaluable at specific time points."|||liter||95% Confidence Interval|Geometric Mean
2681679|NCT01390818|Secondary|Total Body Clearance (CL/f) of Pimasertib (MSC1936369B)|The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the Dose with area under the plasma concentration time curve from time zero to infinity (AUC0 inf)=Dose/AUC0- inf.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here N signifies number of subjects evaluable for this outcome measure and “n” signifies the number of subjects evaluable at the specific time points."|||litre per hour (L/hr)||95% Confidence Interval|Geometric Mean
2681680|NCT01390818|Secondary|Half-Life (t1/2) of MSC1936369B (Pimasertib)||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||hour||Full Range|Median
2681681|NCT01390818|Secondary|Area Under the Concentration-Time Curve (AUC) During a Dosing Interval (Tau) of Pimasertib (MSC1936369B)||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The PK analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||hr*ng/mL||95% Confidence Interval|Geometric Mean
2693594|NCT01294163|Secondary|Arterial Oxygen Saturation|Arterial blood gases|4 hours|||||||
2681682|NCT01390818|Secondary|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC 0-inf) of Pimasertib (MSC1936369B) at Day 1|"Area under the concentration-time curve from time 0 extrapolated to infinity, calculated as AUC0-t + last observed concentration (Clast)/terminal rate constant (λz), using the Linear up/Log down method.~Terminal rate constant (λz)."|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1 for DE cohorts|"The PK analysis set. Here N signifies the number of subjects evaluable for this outcome measure. Data was not available for 'Pimasertib (MSC1936369B) 60mg Twice Daily' arm as no subjects were considered evaluable because of limited number of samples collected to characterize the terminal phase rate constant needed for the calculation of AUCinf."|||hr*ng/mL||95% Confidence Interval|Geometric Mean
2681683|NCT01390818|Secondary|Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of Pimasertib (MSC1936369B)|Area under the concentration-time curve from time 0 to the last quantifiable concentration.|Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set . Here n signifies the number of subjects evaluable at the specific time points."|||hour*nanogram per millilitre (hr*ng/mL)||95% Confidence Interval|Geometric Mean
2681684|NCT01390818|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Pimasertib (MSC1936369B)||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|"The PK analysis set. Here n signifies the number of subjects evaluable at the specific time points."|||hour||Full Range|Median
2681685|NCT01390818|Secondary|Maximum Observed Plasma Concentration (Cmax) for Pimasertib (MSC1936369B)||Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts|The pharmacokinetic (PK) analysis set. Here “n” signifies the number of subjects evaluable at the specific time points.|||nanogram/millilitre (ng/mL)||95% Confidence Interval|Geometric Mean
2681686|NCT01390818|Secondary|Number of Subjects Experiencing Any Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as those AEs that started between first dose of study drug and up to 30 days after last dose.|Baseline up to 30 Days after last dose; assessed up to 4 years|The safety analysis set (SAF) analysis set was to include all subjects who had received at least 1 (non-zero) administration of the trial investigational medicinal products (IMPs) MSC1936369B (pimasertib) and/or SAR245409.|||subjects|||Number
2681687|NCT01390818|Primary|Number of Subjects With Dose Limiting Toxicities (DLT)|DLT was defined as any of the following toxicities experienced during the first cycle of treatment at any dose level (DL) and judged not to be related to the underlying disease or any concomitant medication by the Investigator and/or the Sponsor: A treatment emergent adverse event (TEAE) of potential clinical significance such that further dose escalation (DE) would have exposed subjects to unacceptable risk. Any Grade greater than or equal to (>=) 3 non-hematological toxicity, except for: Grade 3 diarrhea, nausea and vomiting with a duration less than or equal to (<=) 48 hours despite adequate supportive care and Alopecia. Grade 4 neutropenia of > 5 days duration or febrile neutropenia. Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia. Any treatment interruption > 2 weeks due to AEs not related to the underlying disease or concomitant medication at any dose level and any severe, life-threatening impairing daily functions complication or abnormality.|Day 1 up to Day 16 in cycle 1|The dose escalation (DE) analysis set included all subjects treated in DE cohorts who received at least 80 percent (%) of pimasertib and 80% of SAR245409 full planned doses in the first cycle (ie, 21-day period from Day 1) of treatment or who experienced a DLT during the first cycle of treatment regardless of the received amount of each drug.|||subjects|||Number
2681688|NCT01390779|Primary|SENSIMED Triggerfish Efficacy|Device's ability to detect ocular pulse frequency concurrent to heart rate, defined as the number of SENSIMED Triggerfish recording intervals showing oscillation at a frequency matching that of heart rate +/- 15%. In absence of eye blinks during sleep, an oscillating pattern is recorded. The frequency of oscillation was determined by independent reviewers for selected SENSIMED Triggerfish 30-second recording intervals for which simultaneous or close to simultaneous heart rate data was recorded. Intervals for which the oscillation frequency on SENSIMED Triggerfish pattern matched heart rate +/- 15% (tolerance due to noise caused by eye and lid movements) were considered accurate. The percentage of accurate intervals was calculated and expected to be at least 75%.|in selected 30-second SENSIMED Triggerfish recording intervals during sleep|One subject was excluded from the analysis due to the absence of a 3-mmHg difference in IOP from wake to sleep. Two subjects were excluded since they had less than 80% of expected SENSIMED Triggerfish data. One subject was excluded from the analysis due to an invalid SENSIMED Triggerfish recording.|||% of accurate recording intervals||95% Confidence Interval|Number
2681689|NCT01390779|Primary|SENSIMED Triggerfish Efficacy|"Investigate the device's capacity to detect changes in IOP from wake to sleep, defined as a significantly positive slope on the SENSIMED Triggerfish recording (obtained on one eye in each subject), based on the established phenomenon that IOP increases from waking to sleep hours. The IOP from wake to sleep was measured in the eye contralateral to that of SENSIMED Triggerfish using pneumatonomtery. Subjects were included in the primary analysis if a difference in IOP of at least 3 mmHg was detected from wake to sleep.~One subject was excluded from the analysis due to the absence of a 3-mmHg difference in IOP from wake to sleep. Two subjects were excluded since they had less than 80% of expected SENSIMED Triggerfish data. One subject was excluded from the analysis due to an invalid SENSIMED Triggerfish recording."|from 1 hour before sleep to 1 hour after sleep|Subjects were included in this analysis if the difference in IOP from wake to sleep was at least 3 mmHg, as determined using pneumatonometry on the eye contralateral to that of SENSIMED Triggerfish, and if the SENSIMED Triggerfish recording contained at least 80% of the expected data points.|||mV/h||Standard Deviation|Mean
2681748|NCT01390038|Secondary|Range of Motion|"Elevation in the scapula plane~Internal rotation with arm at the side~External rotation with arm at the side"|24 months||||Degrees||Standard Deviation|Mean
2681749|NCT01390038|Secondary|Quality of Life|"Simple Shoulder Test~1 (worse) - 12 (best)"|24 months||||units on a scale||Standard Deviation|Mean
2681692|NCT01390441|Primary|Number of Participants Positive for Anti-Drug Antibody (ADA) Formation in the Extension Study|Serum ADA positivity is determined over course of therapy with MK-8808 in the Extension Study.|Week 54, Week 56, Week 68, Week 80, Week 82, Week 94, Week 106|The analysis was not performed due to early termination of the study after Part A. Blood sampling in the Extension Study was performed without further laboratory quantification for this outcome measure.||||||
2681693|NCT01390441|Primary|Number of Participants With Immunoglobulin G (IgG) Response in the Extension Study|Serum IgG levels are determined over course of therapy with MK-8808 in the Extension Study.|Week 54, Week 68, Week 80, Week 94, Week 106|The analysis was not performed due to early termination of the study after Part A. Blood sampling in the Extension Study was performed without further laboratory quantification for this outcome measure.||||||
2681694|NCT01390441|Other Pre-specified|Change From Baseline in Disease Activity in 28 Joints C-Reactive Protein Score (DAS28-CRP) by Time-point|The DAS28-CRP is a combination scoring method for function using the European League against Rheumatism (EULAR) 28 joint count and the CRP value. The DAS28-CRP scores range from 2.0 to 10.0 with higher values indicating a higher disease activity. A DAS28-CRP below the score of 2.6 is interpreted as Remission. CRP values below lower limit of quantification (LLQ) (<0.4 mg/dL) were set to 0.2 mg/dL in the calculation of DAS28-CRP.|Baseline, Week 6, Week 12|FAS defined as all randomized participants who received at least one complete treatment course (2 doses) and had at least one post-treatment measurement. Patients were included in the treatment group to which they were randomized. A patient might have been be excluded from the FAS population for a given endpoint for multiple reasons.|||Score||Standard Deviation|Mean
2681695|NCT01390441|Other Pre-specified|Part B: Number of ACR20, ACR50, and ACR70 Responders at Week 24|"American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD & IGAD: assessment of function on a 4-point Likert scale: 0=very well to 3=unable to do PGAP: pain due to arthritis measured on a 0-100 mm visual analog scale: Left hand marker-no pain; right hand marker-extreme pain HAQ-DI: assessment of 8 daily living activities (dress/groom; arise; eat; walk; reach; grip; hygiene; common daily activities) on 4-point Likert scale: 0=no difficulty to 3=unable to do"|Week 24|FAS defined as all randomized participants who received at least one complete treatment course (2 doses) and had at least one post-treatment measurement. Patients were included in the treatment group to which they were randomized. A patient might have been be excluded from the FAS population for a given endpoint for multiple reasons.|||Participants|||Number
2681696|NCT01390441|Other Pre-specified|Part A: Number of ACR20, ACR50, and ACR70 Responders at Week 24|"American College of Rheumatology (ACR) Responder Index is based on a set of evaluations: the Investigator Tender Joint Count/Number of Tender Joints (out of 68 Joints); Investigator Swollen Joint Count/Number of Swollen Joints (out of 66 Joints); Patient Global Assessment of Disease Activity (PGAD); Investigator Global Assessment of Disease Activity (IGAD); Patient Global Assessment of Pain (PGAP); Health Assessment Questionnaire Disability Index (HAQ-DI); and ESR. ACR response indicates percent change (ie, improvement) from baseline (20%, 50%, 70%) PGAD & IGAD: assessment of function on a 4-point Likert scale: 0=very well to 3=unable to do PGAP: pain due to arthritis measured on a 0-100 mm visual analog scale: Left hand marker-no pain; right hand marker-extreme pain HAQ-DI: assessment of 8 daily living activities (dress/groom; arise; eat; walk; reach; grip; hygiene; common daily activities) on 4-point Likert scale: 0=no difficulty to 3=unable to do"|Week 24|Full Analysis Set defined as all randomized participants who received at least one complete treatment course (2 doses) and had at least one post-treatment measurement. Patients were included in the treatment group to which they were randomized. A patient might have been be excluded from the FAS population for a given endpoint for multiple reasons.|||Participants|||Number
2681697|NCT01390441|Secondary|Part B: Cmax After the Second Infusion of a Single Course of Treatment|Cmax is a measure of the maximum plasma concentration of drug; samples are collected on Day 15 after the second infusion of the first course of treatment.|Day 15|PK analysis for Part B was not performed due to early termination of the study after Part A. Blood sampling in Part B was performed without further laboratory quantification for this outcome measure.||||||
2681698|NCT01390441|Secondary|Part A: Maximum Concentration (Cmax) After the Second Infusion of a Single Course of Treatment|Cmax is a measure of the maximum plasma concentration of drug; samples are collected on Day 15 after the second infusion of the first course of treatment. Descriptive data values and associated dispersion measures (confidence intervals) are expressed in terms of the factor 10E3.|Day 15|Participants who completed a full course of MK-8808 or MabThera® (two full doses of 500 mg/m^2 on Days 1 and 15); had no major protocol violations; had a complete PK profile; had serum MK-8808 or MabThera® concentrations prior to the first dose of the first course not exceeding 5% of Cmax after the first dose of the first course.|||ng/mL||95% Confidence Interval|Geometric Mean
2681699|NCT01390441|Primary|Number of Participants Who Discontinued Study Drug Due to Adverse Events|Discontinuation/withdrawal of study treatment due to an adverse event was performed at the discretion of the investigator or the Sponsor for safety concerns. An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Parts A and B: Up to Week 28; Extension A and B: Up to 82 weeks|APaT population defined as all participants who received at least one dose of study drug.|||Participants|||Number
2681700|NCT01390441|Primary|Number of Participants Who Experienced at Least One Adverse Event|An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.|Parts A and B: Up to 52 weeks; Extension A and B: Up to 106 weeks|All Participants as Treated (APaT) population defined as all participants who received at least one dose of study drug.|||Participants|||Number
2681750|NCT01390038|Primary|Device Success Rate|"A subject is a Patient Success at 24-months if:~There is NO continuous radiolucent line around the prosthesis; and~The adjusted Constant Score is > 85 (successful outcome); and~They did not have revision surgery; and~They did not have a system-related serious adverse event."|24 months||||participants|||Number
2681701|NCT01390441|Primary|Part B: Area Under the Concentration-time Curve From Day 0 to Day 84 (AUC0-84day) After a Single Course of Treatment|AUC is a measure of the amount of drug in the plasma over time; samples are collected at intervals from pre-dose up to 84 days after the dose.|Day 1 (pre- and post-dose), Day 3, Day 5, Day 8, Day 15, Day 17, Day 19, Day 22, Day 29, Day 43, Day 57, Day 85|PK analysis for Part B was not performed due to early termination of the study after Part A. Blood sampling in Part B was performed without further laboratory quantification for this outcome measure.||||||
2681702|NCT01390441|Primary|Part A: Area Under the Concentration-time Curve From Day 0 to Day 84 (AUC0-84day) After a Single Course of Treatment|AUC is a measure of the amount of drug in the plasma over time; samples are collected at intervals from pre-dose up to 84 days after the dose. Descriptive data values and associated dispersion measures (confidence intervals) are expressed in terms of the factor 10E6.|Day 1 (pre- and post-dose), Day 3, Day 5, Day 8, Day 15, Day 17, Day 19, Day 22, Day 29, Day 43, Day 57, Day 85|Participants who completed a full course of MK-8808 or MabThera® (two full doses of 500 mg/m^2 on Days 1 and 15), had no major protocol violations, had a complete pharmacokinetic (PK) profile, had serum MK-8808 or MabThera® concentrations prior to the first dose of the first course not exceeding 5% of Cmax after the first dose of the first course|||hr*mg/mL||95% Confidence Interval|Geometric Mean
2681703|NCT01390428|Primary|Apparent Terminal Half-life (t1/2) of Grazoprevir|Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Day 10 in order to determine the plasma t1/2 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Day 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.|||hr.||Geometric Coefficient of Variation|Geometric Mean
2681704|NCT01390428|Primary|Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 10|Blood samples were collected at 24 hours post-dose on Day 10 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Days 10 at 24 hours postdose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.|||nM||95% Confidence Interval|Geometric Mean
2681705|NCT01390428|Primary|Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 1 for Participants With Severe HI and Healthy Matched to Severe HI|Blood samples were collected at 24 hours post-dose on Day 1 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Day 1 at 24 hours postdose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants with Mild HI, Moderate HI and Healthy Matched to Mild HI or Moderate HI are absent because they had a different Measure Type and Method of Dispersion|||nM||Full Range|Median
2681706|NCT01390428|Primary|Concentrations 24 Hours Post-dose (C24) of Grazoprevir on Day 1 for Participants With Mild HI and Moderate HI and Healthy Matched to Mild HI and Moderate HI|Blood samples were collected at 24 hours post-dose on Day 1 in order to determine the plasma C24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Day 1 at 24 hours postdose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. Participants with Severe HI and Matched Healthy to Severe HI are absent because they had a different Measure Type and Method of Dispersion|||nM||95% Confidence Interval|Geometric Mean
2681707|NCT01390428|Primary|Time to Peak Concentration (Tmax) of Grazoprevir|Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Tmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.|||hr.||Full Range|Median
2681708|NCT01390428|Primary|Maximum Concentration (Cmax) of Grazoprevir|Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma Cmax of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.|||uM||95% Confidence Interval|Geometric Mean
2681709|NCT01390428|Primary|Area Under the Concentration Time-curve From 0 to 24 Hours (AUC0-24) of Grazoprevir|Blood samples were collected at pre-dose, and from 0.5 to 24 hours post-dose on Days 1 and 10 in order to determine the plasma AUC0-24 of Grazoprevir. Classification of HI based on the Child-Pugh scale, where a score of 5-6 = Mild HI; a score of 7-9 = Moderate HI; and a score of 10-15 = Severe HI.|Days 1 and 10 at the following timepoints: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose|Participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.|||uM*hr||95% Confidence Interval|Geometric Mean
2681710|NCT01390415|Secondary|Diastolic Blood Pressure (DBP)|DBP at baseline and month 6.|Baseline and Month 6||||mmHg||Standard Deviation|Mean
2681711|NCT01390415|Secondary|Systolic Blood Pressure (SBP)|SBP at baseline and month 6.|Baseline and Month 6||||mmHg||Standard Deviation|Mean
2681712|NCT01390415|Primary|Number of Participants With Macroalbuminuria After 6 Months of Treatment|Macroalbuminuria was defined as having an albumin/creatinine ratio (ACR) >300 mg/g and ≥30% increase from baseline.|Baseline and Month 6||||participants|||Number
2682933|NCT01380093|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Morphine||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs||Standard Deviation|Mean
2681713|NCT01390402|Primary|Number of Participants With Molecular Complete Remission at 3 Month Post Transplant|Molecular Complete Remission is defined as participant alive and engrafted with molecular complete remission 100 days post transplant where molecular complete response is no BCR-ABL transcripts detected and engraftment is defined as the evidence of donor derived cells (more than 95%) by chimerism studies in the presence of neutrophil recovery by day 28 post stem cell infusion.|Baseline to up to 4 months post-transplant||||participants|||Number
2681714|NCT01390389|Secondary|To Determine Effects of CoQ 10 on Bioenergetics (PCr and Beta NTP) in Older Adults With Bipolar Depression.|Changes in Phosphocreatine and beta NTP (represented as adenosine triphosphate) in gray matter and white matter will be determined by measurements at Week 0 and Week 4 in Geri BD group challenged with CoQ10 and in healthy controls.|4-week trial|Healthy controls with no evidence of current or past psychiatric disorders, and subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in the CoQ10 group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.|||Integration Expressed as Arbitrary Unit||Standard Error|Least Squares Mean
2681715|NCT01390389|Primary|Mean Concentrations of Cerebral Energetic Metabolites in Geriatric BPD and Older Controls at Baseline|Tissue-specific (gray or white matter) concentrations of of Phosphocreatine (PCr), Beta-Nucleoside Triphosphate (bNTP), and Inorganic Phosphate (Pi) in geriatric BPD compared with healthy controls at baseline. Concentrations were measured using CSI P MRS scan at 4T. The analysis of signal intensity is done through integration of the area under the curve and is expressed in arbitrary units.|Baseline||||Integration Expressed as Arbitrary Unit||Standard Error|Mean
2681716|NCT01390298|Primary|Self-reported Pain Intensity|"McGill Pain Questionnaire: 0-10 Visual Analog Scale for self reported pain intensity 0= no pain 10= worst pain imaginable Lower score denotes better outcomes~Visual Analog Scores were obtained during the following times:~Twice daily: day of hospital discharge through postoperative day 14 Once daily postoperative day 15 through postoperative day 28 Once weekly postoperative day 29 through postoperative day 85 Once monthly postoperative day 86 through postoperative day 168~Longitudinal analysis of primary outcome measure over time was estimated by longitudinal mixed models and not one mean and standard deviation.~The change in pain over time was modeled by 7.7344 - 1.6013(log(time))"|Day of hospital discharge to postoperative day 168|Lower Extremity Total Joint Arthroplasty (TJS) Cohort (n=31)|||units on a scale||Standard Deviation|Mean
2681717|NCT01390272|Secondary|Number of Participants Who Did Not Achieve Medication Adherence|"The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:~Do you ever forget to take your blood pressure medicine?~Are you careless at times about taking your blood pressure medicine?~When you feel better do you sometimes stop taking you blood pressure medicine?~Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer.~A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence.~The numbers in the descriptive tables reflect number non-adherent."|18 months|"37 out of the 192 participants in the Titration Intervention group and 33 out of the 193 in the LPN control group had missing medication adherence at 18 months due to not completing the assessment.~The numbers in the descriptive tables reflect #non-adherent."|||Participants|||Count of Participants
2681718|NCT01390272|Secondary|Number of Participants Who Did Not Achieve Medication Adherence|"The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:~Do you ever forget to take your blood pressure medicine?~Are you careless at times about taking your blood pressure medicine?~When you feel better do you sometimes stop taking you blood pressure medicine?~Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer.~A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence.~The numbers in the descriptive tables reflect number non-adherent."|12 months|"53 out of the 192 participants in the Titration Intervention group and 34 out of the 193 in the LPN control group had missing medication adherence at 12 months due to not completing the assessment.~The numbers in the descriptive tables reflect #non-adherent."|||Participants|||Count of Participants
2681719|NCT01390272|Secondary|Number of Participants Who Did Not Achieve Medication Adherence|"The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:~Do you ever forget to take your blood pressure medicine?~Are you careless at times about taking your blood pressure medicine?~When you feel better do you sometimes stop taking you blood pressure medicine?~Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer.~A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence.~The numbers in the descriptive tables reflect number non-adherent."|6 months|"30 out of the 192 participants in the Titration Intervention group and 21 out of the 193 in the LPN control group had missing medication adherence at 6 months due to not completing the assessment.~The numbers in the descriptive tables reflect #non-adherent."|||Participants|||Count of Participants
2681720|NCT01390272|Secondary|Number of Participants Who Did Not Achieve Medication Adherence|"The investigators assessed adherence using patient self-report on a modified Morisky scale using 4 items:~Do you ever forget to take your blood pressure medicine?~Are you careless at times about taking your blood pressure medicine?~When you feel better do you sometimes stop taking you blood pressure medicine?~Sometimes if you feel worse when you take your blood pressure medicine, do you stop taking it? The scale is a Yes(0) or No (1) answer.~A response of YES to any one of the 4 items indicated non-adherence, and responses of all no indicated adherence.~The numbers in the descriptive tables reflect number non-adherent."|Baseline|The numbers in the descriptive tables reflect #non-adherent.|||Participants|||Count of Participants
2681721|NCT01390272|Secondary|Cost Effectiveness|"One of our secondary research questions was: If the intervention results in greater reduction in SBP than the control group, is it cost effective?~Intervention results did not show statistically significant differences between arms, therefore cost effectiveness analysis was not appropriate.~While cost effectiveness was not analyzed because it was a null trial, the investigators would have used resource utilization and cost data from VA data sets to measure VA outpatient and inpatient utilization and costs by arms over 18 months. The investigators would have examined hypertension-related outpatient pharmacy prescription counts and costs in order to compare them to total outpatient pharmacy costs and the investigators would have examined inpatient utilization and costs."|Over 18 months of study intervention|Intervention results did not show statistically significant differences between arms, therefore cost effectiveness analysis is not appropriate.||||||
2681722|NCT01390272|Secondary|Number of Participants With Hypertension Control|The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms. Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the18- month study visit.|18 months|37 out of the 192 participants in the Titration Intervention group and 33 out of the 193 in the LPN control group had missing blood pressure measurement at 18 months due to not completing the assessment.|||Participants|||Count of Participants
2681723|NCT01390272|Secondary|Number of Participants With Hypertension Control|The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms. Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 12-study visit.|12 months|53 out of the 192 participants in the Titration Intervention group and 34 out of the 193 in the LPN control group had missing blood pressure measurement at 12 months due to not completing the assessment.|||Participants|||Count of Participants
2681724|NCT01390272|Secondary|Number of Participants With Hypertension Control|The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms. Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 6-month study visit.|6 months|30 out of the 192 participants in the Titration Intervention group and 22 out of the 193 in the LPN control group had missing blood pressure measurement at 6 months due to not completing the assessment. One additional participant in the LPN control had missing blood pressure measurement at 6 months due to not being able to get a reading.|||Participants|||Count of Participants
2681725|NCT01390272|Secondary|Number of Participants With Hypertension Control|The investigators examined the difference in the degree of systolic BP control over the 18 months of the study between the intervention and control arms. Control was defined as SBP < 130mmHg for hypertensive patients with diabetes and < 140mmHg for patients without diabetes. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the baseline study visit.|Baseline|Mean systolic blood pressure in control (units: participants)|||Participants|||Count of Participants
2681726|NCT01390272|Primary|Systolic Blood Pressure|Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the18- month study visits.|18 months|37 out of the 192 participants in the Titration Intervention group and 33 out of the 193 in the LPN control group had missing blood pressure measurement at 18 months due to not completing the assessment.|||mmHg||Standard Deviation|Mean
2681727|NCT01390272|Primary|Systolic Blood Pressure|Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the12-month study visits.|12 months|Analysis Population Description: Analysis Population Description: 53 out of the 192 participants in the Titration Intervention group and 34 out of the 193 in the LPN control group had missing blood pressure measurement at 12 months due to not completing the assessment.|||mmHg||Standard Deviation|Mean
2681728|NCT01390272|Primary|Systolic Blood Pressure|Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the 6- month study visits.|6 months|30 out of the 192 participants in the Titration Intervention group and 22 out of the 193 in the LPN control group had missing blood pressure measurement at 6 months due to not completing the assessment. One additional participant in the LPN control had missing blood pressure measurement at 6 months due to not being able to get a reading.|||mmHg||Standard Deviation|Mean
2681729|NCT01390272|Primary|Systolic Blood Pressure|Continuous change in systolic blood pressure was measured as the primary outcome. Mean systolic blood pressure was calculated by the average of 3 blood pressure measurements collected at the baseline study visits.|Baseline||||mmHg||Standard Deviation|Mean
2681730|NCT01390259|Secondary|Mean Glucose|Average plasma glucose concentration in mg/dl|22 hours||||mg/dL||Standard Error|Mean
2681731|NCT01390259|Secondary|Percent Time in Euglycemia|Percent of time the patient plasma glucose as measured by YSI is between 70mg/dl and 180mg/dl|22 hours||||percentage of time in range||Standard Error|Mean
2681732|NCT01390259|Primary|Hypoglycemic Events|"Number of hypoglycemic events below 70 mg/dL per patient per day~Hypoglycemic event is defined as consecutive YSI plasma glucose measurements below 70 or moderate hypoglycemic symptoms"|22 hours||||events/patient||Standard Error|Mean
2681733|NCT01390246|Primary|Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Pregnancy (Visit 7)|The accuracy of self-reported smoking abstinence during study visits was confirmed by an exhaled carbon monoxide (CO) levels and by urinary cotinine levels. 7-day point prevalence abstinence was defined as no cigarettes (not even a puff) in the last 7 days, levels of (CO) in exhaled air < 4 ppm, and concentrations of cotinine in urine < 50 ng/mL. At every visit, a research nurse monitored the smoking status of all subjects (amount of cigarettes per day, exhaled CO). Exhaled CO was measured using a Vitalograph carbon monoxide monitor (Lenexa, KS) according to the manufacturer's recommendations. A urine sample was collected at each visit and cotinine in urine was quantified using the validated liquid chromatography-mass spectrometry (LC/MS) method. We calculated the total number of abstinent subjects. The higher the number the better outcome.|End of pregnancy (visit 7) is a time period between 36.0-38.6 weeks gestation||||Participants|||Count of Participants
2681751|NCT01389973|Secondary|Part 1: Percent Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase, and Bilirubin Concentration at Week 28||Baseline and Week 28|"Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial). N (number of participants analyzed) signifies participants who were evalubale for this outcome measure. n signifies participants who were evalubale for each specified category."|||percent change||Standard Deviation|Mean
2681752|NCT01389973|Secondary|Part 1: Percent Change From Baseline in ALP Concentration at Week 28||Baseline and Week 28|Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial).|||percent change||Standard Deviation|Mean
2681734|NCT01390246|Primary|Number of Participants With 7-day Point Prevalence Smoking Abstinence at the End of Medication Treatment (Visit 6)|The accuracy of self-reported smoking abstinence during study visits was confirmed by an exhaled carbon monoxide (CO) levels and by urinary cotinine levels. 7-day point prevalence abstinence was defined as no cigarettes (not even a puff) in the last 7 days, levels of (CO) in exhaled air < 4 ppm, and concentrations of cotinine in urine < 50 ng/mL. At every visit, a research nurse monitored the smoking status of all subjects (amount of cigarettes per day, exhaled CO). Exhaled CO was measured using a Vitalograph carbon monoxide monitor (Lenexa, KS) according to the manufacturer's recommendations. A urine sample was collected at each visit and cotinine in urine was quantified using the validated liquid chromatography-mass spectrometry (LC/MS) method. We calculated the total number of abstinent subjects. The higher the number the better outcome.|Visit 6 (end of 12 weeks of medication therapy)||||Participants|||Count of Participants
2681735|NCT01390246|Primary|Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups on the Quit Date|Cigarette craving and withdrawal symptoms were assessed by the Minnesota Nicotine Withdrawal Scale (MNWS). MNWS consists of 7 objectives (e.g., irritability, anxious, depressed mood, difficulty concentrating, increased appetite, insomnia, restless). Subjects were given a score on each item on a scale of 0 (not present) to 4 (severe). Summed (total) score excluding craving represent subject's symptoms of tobacco withdrawal, ranging from 0 to 28. We calculated a craving for tobacco score and a total score of withdrawal symptoms excluding craving. The higher score represent more sever craving and withdrawal.|Quit date, visit 2 (one week after starting the 12-week course of therapy)||||MNWS Score||Standard Deviation|Mean
2681736|NCT01390246|Primary|Change in Cigarette Craving and Total Nicotine Withdrawal Symptoms Between Groups During Medication Treatment|Cigarette craving and withdrawal symptoms were assessed by the Minnesota Nicotine Withdrawal Scale (MNWS). MNWS consists of 7 objectives (e.g., irritability, anxious, depressed mood, difficulty concentrating, increased appetite, insomnia, restless). Subjects were given a score on each item on a scale of 0 (not present) to 4 (severe). Summed (total) score excluding craving represent subject's symptoms of tobacco withdrawal, ranging from 0 to 28. We calculated a craving for tobacco score and a total score of withdrawal symptoms excluding craving. The higher score represent more sever craving and withdrawal.|During treatment: Visits 2-6 (time period between 2nd and 12th week of therapy)||||MNWS Score||Standard Deviation|Mean
2681737|NCT01390233|Primary|Vaginal Delivery|The primary outcome of this study is vaginal delivery of a liveborn singleton pregnancy. The outcome is considered a vaginal delivery if accomplished by spontaneous vaginal delivery, operative forceps or vacuum forceps. The alternate outcome is delivery by cesarean section.|Gestational age 26-42 weeks||||participants|||Number
2681738|NCT01390220|Secondary|Time to Next Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose|Time to next seizure with a start time >10 minutes and up to 24 hours after administration of the double-blind dose in the CP. Participants who did not have another seizure before the end of the 24-hour observation period were censored at the end of the observation period. Participants administered the open-label second dose who did not have a seizure were censored at the time of the administration.|24 hours|Randomized participants who received the double-blind dose in the CP|||Hours||95% Confidence Interval|Median
2681739|NCT01390220|Secondary|Occurrence of Seizure With a Start Time >10 Minutes After Administration of the Double-blind Dose|Occurrence of next seizure with a start time >10 minutes and up to 24 hours after administration of the double-blind dose in the CP. Participants who did not have another seizure before the end of the 24-hour observation period were censored at the end of the observation period. Participants administered the open-label second dose who did not have a seizure were censored at the time of the administration.|24 hours|Randomized participants who received the double-blind dose in the CP.|||Participants|||Count of Participants
2681740|NCT01390220|Secondary|Participants With Seizure(s) >10 Minutes to 4 Hours After Administration of the Double-blind Dose|Participants with recurrence of seizure(s) >10 minutes and up to 4 hours after administration of the double-blind dose in the CP. Participants who received the open-label second dose within 4 hours of administration of the double-blind dose were analyzed as having had a seizure.|4 hours|Randomized participants who received the double-blind dose in the CP.|||Participants|||Count of Participants
2681741|NCT01390220|Primary|Participants Who Met the Criteria for Treatment Success After Administration of the Double-blind Dose in the Comparative Phase (CP)|Treatment Success is defined as achieving both of the following: 1) termination of seizure(s) within 10 minutes after double-blind study drug administration, and 2) no recurrence of seizure(s) beginning 10 minutes after study drug administration to 6 hours after study drug administration. Participants who received the open-label second dose within 6 hours of administration of the double-blind dose were analyzed as having had a seizure.|6 hours|Randomized participants who received the double-blind dose in the CP.|||Participants|||Count of Participants
2681742|NCT01390181|Primary|Inflammatory Markers Levels|Changes in levels of Matrix Metalloproteinase (MMP-2, MMP-9), Tissue Inhibitor of Metalloproteinases (TIMP 1, TIMP 2), & Transforming Growth Factor-Beta (TGFB) in circulation while taking medication from baseline at 3 months, 6 months and 12 months. The 12 month levels were the primary outcome.|Baseline and 12 months|No participants were analyzed because the study terminated prior to data collection for final primary outcome measure.||||||
2681743|NCT01390064|Primary|Number of Participants With a Dose-limiting Toxicity (Defined as an Adverse Event of Grade 3 or Higher)|The safety and tolerability of the P10s-PADRE/MONTANIDE ISA51 VG vaccine will be determined by toxicity assessments throughout the duration of the study. Subjects will be evaluated for toxicity using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.|9 weeks per subject||||participants|||Number
2681744|NCT01390038|Secondary|Pain: Visual Analog Scale|0 (best) - 10 (worst)|24 Months||||units on a scale||Standard Deviation|Mean
2681745|NCT01390038|Secondary|American Shoulder and Elbow Surgeon Score|0 (worst) - 100 (best)|24 Months||||units on a scale||Standard Deviation|Mean
2681746|NCT01390038|Secondary|Device Parameters|"Devices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty:~Migration~Osteolysis~Subsidence"|24 months||||Percentage of participants|||Number
2681747|NCT01390038|Secondary|Strength|Strength of a Specific shoulder motion as measured in pounds of force on a dynamometer machine supplied by Tornier|24 months||||Pounds||Standard Deviation|Mean
2681753|NCT01389973|Secondary|Part 1: Number of Participants With ALP Remission at Week 28|ALP remission is defined as either normalization of ALP (for participants with baseline ALP between 1.67*and 2.8* upper limit of normal [ULN] or an ALP less than [˂]1.67*ULN [for participants with baseline ALP greater than {˃} 2.8* ULN]). ALP levels above 1.67* ULN level were associated with an increased rate of disease progression.|Week 28|Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial).|||participants|||Number
2681754|NCT01389973|Secondary|Part 1: Number of Participants With ALP Response at Week 28||Week 28|Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial).|||participants|||Number
2681755|NCT01389973|Primary|Part 1: Number of Participants With Alkaline Phosphatase (ALP) Response at Week 12|The ALP response was defined as a greater than 40 percent (%) decrease from Baseline in ALP concentration at Week 12.|Week 12|Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial).|||participants|||Number
2681756|NCT01389882|Secondary|Capillary Blood HCO3|Capillary blood HCO3 checked immediately after the 4-hour respiratory support with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||mmol/L||Standard Deviation|Mean
2681757|NCT01389882|Secondary|Capillary Blood pO2|Capillary blood pO2 checked immediately after the 4-hour respiratory support with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||mmHg||Standard Deviation|Mean
2681758|NCT01389882|Secondary|Capillary Blood pCO2|Capillary blood pCO2 checked immediately after the 4-hour respiratory support with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||mmHg||Standard Deviation|Mean
2681759|NCT01389882|Secondary|Capillary Blood pH|Capillary blood pH checked immediately after the 4-hour respiratory support with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||pH||Standard Deviation|Mean
2681760|NCT01389882|Secondary|Fraction of Oxygen|Fraction of oxygen measured by a ventilator for 4 hours with each ventilator mode|four hours||||percentage of concentration||Full Range|Median
2681761|NCT01389882|Secondary|Peak EAdi|Peak electrical activity of the diaphragm|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||uV||Standard Deviation|Mean
2681762|NCT01389882|Secondary|Work of Breathing|Work of breathing of patients measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||mJ/L||Full Range|Median
2681763|NCT01389882|Secondary|Dynamic Compliance|Dynamic Compliance measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||mL/cmH2O||Standard Deviation|Mean
2681764|NCT01389882|Secondary|Expiratory Tidal Volume|Expiratory tidal volume measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||mL/Kg||Standard Deviation|Mean
2681765|NCT01389882|Secondary|Minute Ventilation|Minute ventilation measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||L/min/Kg||Standard Deviation|Mean
2681766|NCT01389882|Secondary|Mean Airway Pressure|mean airway pressure measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||cmH2O||Standard Deviation|Mean
2681767|NCT01389882|Primary|Peak Inspiratory Pressure|peak inspiratory pressure measured by a ventilator for 4 hours with each ventilator mode|four hours|"The analysis was per protocol. 19 patients who had completed the study was used for the analysis."|||cmH2O||Standard Deviation|Mean
2681768|NCT01389856|Secondary|Accumulation Index (AI) for Bosentan|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Days 1 and 5. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AI was calculated as the ratio AUCtau /AUC0-12 for the subjects having PK samples collected on Day 1 and Day 5 and with AUC0-12 > 0 ng.h/mL.|5 days|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||accumulation index||95% Confidence Interval|Geometric Mean
2681769|NCT01389856|Secondary|Area Under the Concentration-time Curve Over a Period of 24 h (Dose-corrected to 2 mg/kg) on Day 5 (AUC0-24C Day 5) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AUC0-24C Day 5 was calculated as a multiple of AUCtau, (2 × AUCtau for 2 times daily dosing) corrected to 2 mg/kg.|24 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||h*ng/mL||95% Confidence Interval|Geometric Mean
2681779|NCT01389856|Secondary|Tmax for Ro 47-8634 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Tmax was obtained directly from the measured concentrations.|up to 12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||hours||Full Range|Median
2681770|NCT01389856|Secondary|Area Under the Concentration-time Curve Over a Period of 24 h (Dose-corrected to 2 mg/kg) on Day 1 (AUC0-24C Day 1) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AUC0-24C Day 1 was calculated as a multiple of AUC0-12, (2 × AUC0-12 for 2 times daily dosing) corrected to 2 mg/kg.|24 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||h*ng/mL||95% Confidence Interval|Geometric Mean
2681771|NCT01389856|Secondary|Area Under the Concentration-time Curve Over a Dosing Interval at Steady State on Day 5 (AUCtau) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AUCtau Day 5 was calculated according to the trapezoidal rule using the measured concentration-time values above the limit of quantification.|5 days|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||h*ng/mL||95% Confidence Interval|Geometric Mean
2681772|NCT01389856|Secondary|Area Under the Concentration-time Curve Over a Period of 12 h (AUC0-12 Day 1)) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Pharmacokinetic parameters were determined on the basis of scheduled blood sampling time points using non-compartmental analysis. Actual blood sampling times were used only if there was a deviation of more than 5% from the scheduled times. AUC0-12 Day 1 was calculated according to the trapezoidal rule using the measured concentration-time values above the limit of quantification.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||h*ng/mL||95% Confidence Interval|Geometric Mean
2681773|NCT01389856|Secondary|Tmax for Ro 64-1056 on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Tmax was obtained directly from the measured concentrations.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||hours||Full Range|Median
2681774|NCT01389856|Secondary|Tmax for Ro 48-5033 on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Tmax was obtained directly from the measured concentrations.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||hours||Full Range|Median
2681775|NCT01389856|Secondary|Tmax for Ro 47-8634 on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Tmax was obtained directly from the measured concentrations.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||hours||Full Range|Median
2681776|NCT01389856|Secondary|Tmax for Bosentan on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Tmax was obtained directly from the measured concentrations.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||hours||Full Range|Median
2681777|NCT01389856|Secondary|Tmax for Ro 64-1056 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Tmax was obtained directly from the measured concentrations.|up to 12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||hours||Full Range|Median
2681778|NCT01389856|Secondary|Tmax for Ro 48-5033 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Tmax was obtained directly from the measured concentrations.|up to 12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||hours||Full Range|Median
2683022|NCT01380080|Secondary|Proportion of Participants With TB Diagnosis Per Current ACTG Diagnosis Appendix by Week 96|Proportion of participants with TB diagnosis per current ACTG Diagnosis Appendix 60 by week 96|From study entry to week 96||2020-12-31|12/2020||||
2681780|NCT01389856|Secondary|Time to Maximum Whole Blood Concentration (Tmax) for Bosentan on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Tmax was obtained directly from the measured concentrations.|up to 12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||hours||Full Range|Median
2681781|NCT01389856|Secondary|Cmax for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056 on Day 5|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to study drug administration and at 0.5, 1, 2, 3, 7.5, and 12 hours post-dose on Day 5. Cmax obtained directly from the measured concentrations . Cmax was corrected to a dose of 2 mg/kg bosentan (Cmaxc). The target dose was 2 mg/kg. However, as the smallest dose unit was 8 mg (quarter of a tablet), it was not possible to achieve the exact target dose in all patients. Therefore, Cmax was divided by the actual dose (in mg/kg) and multiplied by 2 mg/kg.|12 hours|PK analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||ng/mL||95% Confidence Interval|Geometric Mean
2681782|NCT01389856|Secondary|Maximum Whole Blood Concentration (Cmax) for Bosentan and Its Metabolites, Ro 47-8634, Ro 48-5033, and Ro 64-1056 on Day 1|Concentrations were measured directly in dried blood spot samples scheduled to be taken immediately prior to first study drug administration and at 0.5, 1, 2, 3, 7.5 and 12 hours post-dose on Day 1. Cmax was obtained directly from the measured concentrations. Cmax was corrected to a dose of 2 mg/kg bosentan (Cmaxc). The target dose was 2 mg/kg. However, as the smallest dose unit was 8 mg (quarter of a tablet), it was not possible to achieve the exact target dose in all patients. Therefore, Cmax was divided by the actual dose (in mg/kg) and multiplied by 2 mg/kg.|up to 12 hours|Pharmacokinetic (PK) analysis set. This analysis set comprised all patients included in the all-treated set who were able to provide at least 5 of the 7 blood samples requested for at least one evaluable profile of PK assessment and who did not violate the protocol in a way that might affect the evaluation of the PK endpoints.|||ng/mL||95% Confidence Interval|Geometric Mean
2681783|NCT01389856|Secondary|Change in Fraction of Inspired Oxygen (FiO2) From Baseline to 72 Hours Following Study Drug Administration|FiO2 was determined according to each study centers' standard procedure at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data|||percentage of oxygen||95% Confidence Interval|Median
2681784|NCT01389856|Secondary|Change in Post-ductal Peripheral Oxygen Saturation (SpO2) From Baseline to 72 Hours Following Study Drug Administration|Simultaneous pre- (right hand) and post-ductal (lower extremities) SpO2 were measured using pulse oximetry device at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data|||percentage saturation||95% Confidence Interval|Median
2681785|NCT01389856|Secondary|Change in Pre-ductal Peripheral Oxygen Saturation (SpO2) From Baseline to 72 Hours Following Study Drug Administration|Simultaneous pre- (right hand) and post-ductal (lower extremities) SpO2 were measured using pulse oximetry device at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data|||percentage saturation||95% Confidence Interval|Median
2681786|NCT01389856|Secondary|Change in Partial Pressure of Carbon Dioxide (PaCO2) in Arterial Blood From Baseline to 72 Hours Following Study Drug Administration|PaCO2 was determined in arterial blood samples at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data|||mm Hg||95% Confidence Interval|Median
2681787|NCT01389856|Secondary|Change in Partial Pressure of Oxygen (PaO2) in Arterial Blood From Baseline to 72 Hours Following Study Drug Administration|PaO2 was determined in arterial blood samples at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data|||mm Hg||95% Confidence Interval|Median
2681788|NCT01389856|Secondary|Change in Arterial Blood Oxygen Saturation (SaO2) From Baseline to 72 Hours Following Study Drug Administration|SaO2 was determined in arterial blood samples at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data|||percentage saturation||95% Confidence Interval|Median
2681789|NCT01389856|Secondary|Change in Arterial Blood Gas (ABG) pH From Baseline to 72 Hours Following Study Drug Administration|pH was determined in arterial blood samples at baseline and 72 h after the first study drug administration|72 hours|Randomized and treated patients with available data|||pH||95% Confidence Interval|Median
2681790|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 72 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|72 hours|Randomized and treated patients with available data|||oxygenation index||95% Confidence Interval|Median
2681791|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 48 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|48 hours|Randomized and treated patients with available data|||oxygenation index||95% Confidence Interval|Median
2681792|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 24 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|24 hours|Randomized and treated patients|||oxygenation index||95% Confidence Interval|Median
2681793|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 12 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|12 hours|Randomized and treated patients|||oxygenation index||95% Confidence Interval|Median
2681794|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 5 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|5 hours|Randomized and treated patients|||oxygenation index||95% Confidence Interval|Median
2681795|NCT01389856|Secondary|Change in Oxygenation Index (OI) From Baseline to 3 Hours Following Study Drug Administration|The change in OI from baseline following study drug administration was determined. OI was calculated as the mean airway pressure multiplied by the fraction of inspired oxygen (expressed in %), and the product was divided by the partial pressure of oxygen in arterial blood.|3 hours|Randomized and treated patients|||oxygenation index||95% Confidence Interval|Median
2681796|NCT01389856|Secondary|Percentage of Patients With Pulmonary Hypertension (PH) at End of Treatment|"The presence of PH was assessed by echocardiography. PH was reported as 'present' if at least one of the following criteria was met:~Shunt through ductus arteriosus was either 'predominant right to left' or 'bidirectional'~Shunt through foramen ovale was either 'predominant right to left' or 'bidirectional'~Marked right ventricular dilation was ticked 'present'~Paradoxical shift of intraventricular septum was ticked 'present'~Right ventricular systolic pressure (mmHg) was > 2/3 of the reported systemic blood pressure"|From baseline to up to 14 days|Randomized and treated patients|||percentage of participants|||Number
2681797|NCT01389856|Secondary|Percentage of Patients Requiring Re-initiation of iNO Therapy|Re-initiation of iNO therapy following weaning from iNO therapy|From baseline to up to 21 days|Randomized and treated patients|||percentage of participants|||Number
2681798|NCT01389856|Primary|Time to Complete Weaning From Mechanical Ventilation|Calculated from the time from first study drug administration to complete weaning from mechanical ventilation|From baseline to up to 21 days|Randomized and treated patients|||days||95% Confidence Interval|Median
2681799|NCT01389856|Primary|Time to Complete Weaning From iNO|Calculated from the time from first study drug administration to complete weaning from iNO. Weaning from iNO was considered complete if there was no requirement for the re-initiation of iNO within 24 h after stopping|From baseline to up to 21 days|Randomized and treated patients|||days||95% Confidence Interval|Median
2681800|NCT01389856|Primary|Percentage of Patients With Treatment Failure|Treatment failure was defined as the need for extra corporeal membrane oxygenation or initiation of alternative pulmonary vasodilator treatment|From baseline to up to 21 days|Randomized and treated patients|||percentage of participants|||Number
2681801|NCT01389817|Primary|N95 Peak Via pERG and fERG -PhNR|The primary comparison will be a paired comparison of pre- and post-treatment retinal ganglion cell N95 pattern electroretinogram (pERG) peaks and fERG - Photopic Negative Response (PhNR). Pairing will be done between a subject's treatment and control eye.|12 months|All participants were withdrawn before any data could be obtained.||||||
2681802|NCT01389765|Primary|Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684||0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose|All participants with a baseline observation and at least 1 post-baseline observation.|||hours||Full Range|Median
2681803|NCT01389765|Primary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2216684|The Cmax for LY2216684 was calculated for LY2216684 administered in fed state (test) and LY2216684 administered in fasted state (reference). Geometric LS means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for Cmax.|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose|All participants with a baseline observation and at least 1 post-baseline observation.|||nanogram/milliliter (ng/mL)||90% Confidence Interval|Least Squares Mean
2681804|NCT01389765|Primary|Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684|The AUC for LY2216684 was calculated for LY2216684 administered in fed state (test) and LY2216684 administered in fasted state (reference). Geometric Least Squares (LS) means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for AUC.|0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose|All participants with a baseline observation and at least 1 post-baseline observation.|||nanogram*hour/milliliter (ng*h/mL)||90% Confidence Interval|Least Squares Mean
2681805|NCT01389752|Primary|Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684|The tmax for LY2216684 was assessed.|Predose, up to 72 hours after administration of study drug|All participants who were randomized, for whom tmax data were available, and who were not excluded due to vomiting within twice the median tmax of LY2216684.|||hours||Full Range|Median
2681806|NCT01389752|Primary|Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2216684|The Cmax of LY2216684 was assessed. The Cmax was calculated for LY2216684 administered alone (reference) and LY2216684 co-administered with charcoal (test). Geometric LSMeans were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for Cmax.|Predose, up to 72 hours after administration of study drug|All participants who were randomized, for whom Cmax data were available, and who were not excluded due to vomiting within twice the median time to maximum plasma concentration (tmax) of LY2216684.|||nanogram/milliliter (ng/mL)||90% Confidence Interval|Geometric Least Squares Mean
2681807|NCT01389752|Primary|Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684|The AUC0-∞ of LY2216684 was measured. The AUC was calculated for LY2216684 administered alone (reference) and LY2216684 co-administered with charcoal (test). Geometric Least Squares (LS) means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for AUC.|Predose, up to 72 hours after administration of study drug|All participants who were randomized, for whom AUC0-∞ data were available, and who were not excluded due to vomiting within twice the median time to maximum plasma concentration (tmax) of LY2216684.|||nanogram*hour/milliliter (ng*h/mL)||90% Confidence Interval|Geometric Least Squares Mean
2681808|NCT01389596|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Physical Examinations at Week 13|Physical examinations evaluated the following body systems/organs: general appearance; dermatological; head and eyes; ears, nose, mouth, and throat; pulmonary; cardiovascular; abdominal; genitourinary (optional); lymphatic; musculoskeletal/extremities; and neurological. Clinical significance was determined by the investigator.|Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13|Safety population included all randomized participants who took at least 1 dose of the study drug.|||participants|||Number
2681809|NCT01389596|Other Pre-specified|Number of Participants With Electrocardiogram (ECG) Abnormalities|Criteria for abnormalities in ECG findings: 1) Time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS complex): >=140 milliseconds (msec); 2) The interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=200 msec; 3) Time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTCF interval): absolute value 450 to <480 msec, 480 to <500 msec, >=500 msec; 4) Maximum QT interval: >=500 msec; 5) Maximum QTCB interval (Bazett's correction): 450 to< 480 msec, 480 to <500 msec, >=500 msec. Only those categories of ECG abnormalities in which participants were found abnormal, were reported in this outcome measure.|Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13|"Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure."|||participants|||Number
2681810|NCT01389596|Other Pre-specified|Number of Participants With Clinically Significant Change From Baseline in Neurological Examinations|Neurological examinations included: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation (the latter using a 128-Hertz tuning fork), coordination and gait. Clinical significance was based on investigator's discretion.|Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13|Safety population included all randomized participants who took at least 1 dose of the study drug.|||participants|||Number
2681811|NCT01389596|Other Pre-specified|Number of Participants With Vital Signs Abnormalities|Criteria for abnormalities in vital signs included: sitting systolic blood pressure (SBP) values: maximum increase and decrease of >=30 millimeter of mercury (mmHg) from baseline; sitting diastolic blood pressure (DBP) value: maximum increase and decrease of >=20 mmHg from baseline.|Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13|"Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure."|||participants|||Number
2681812|NCT01389596|Other Pre-specified|Number of Participants With Clinically Significant Laboratory Abnormalities|Criteria for abnormality: hematology (hemoglobin, hematocrit, red blood cells count:<]0.8*lower limit of normal [LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],leukocytes:<0.6*LLN or>1.5*ULN, lymphocytes, total neutrophils:<0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes:>1.2*ULN); Liver Function(aspartate aminotransferase ,alanine aminotransferase, alkaline phosphatase, Gamma glutamyl transferase:>0.3*ULN, total protein, albumin:<0.8*LLN or >1.2*ULN); bilirubin:>1.5*ULN; renal function(blood urea nitrogen, creatinine:>1.3*ULN); Electrolytes(sodium:<0.95*LLN or>1.05*ULN, potassium, chloride, calcium, bicarbonate:<0.9*LLN or >1.1*ULN); Lipids(cholesterol, triglycerides >1.3*ULN); creatine kinase:>2.0*ULN; glucose fasting:<0.6*LLN or >1.5*ULN, urine white blood corpuscles and RBC:>= 20/High Power Field [HPF];urine casts: >1/Low Power Field(LPF);urine bacteria:>20/HPF. Hormones (tetraiodothyronine and thyroid stimulating hormone:<0.8*LLN or >1.2*ULN).|Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13|"Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure."|||participants|||Number
2681813|NCT01389596|Other Pre-specified|Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Week 12: Paediatric Identification (Go-No Go: Attention) Tasks|"CogState battery: computerized test battery used to assess cognitive domains through cognition tests/tasks. The test battery was presented on computer with external response buttons. Paediatric identification task: a measure of choice reaction time and valid assessment of visual attention. In this task, a playing card turning face up was presented in center of the computer screen. As soon as this happened, participant had to decide whether color of card was black or not. If color was black, participants was to press Yes response key, otherwise no. There was no minimum/maximum scores since it was a time-based assessment. The software measured speed of accurate responses (correct identification of color) to each event. In this outcome measure, speed of performance of participants to correctly identify the color (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Lower scores indicated better performance."|Baseline (pre-dose at Day 1), Week 12|"Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and ‘n’ signifies number of participants evaluated for specific categories for each arm respectively."|||log10 milliseconds||Standard Deviation|Mean
2681814|NCT01389596|Other Pre-specified|Change From Baseline in Cognitive Test Battery (CogState Battery) Scores at Week 12: Detection Task|CogState battery:computerized test battery used to assess cognitive domains through cognition tests/tasks. The test battery was presented on computer with external response buttons. In this study, Cogstate battery consisted of 2 tasks which measured psychomotor function (detection task) and attention (paediatric identification task). Detection task was a measure of simple reaction time and provided a valid assessment of psychomotor function in participants. In this task, a playing card turning face up was presented in the center of the computer screen. As soon as this happened, the participant was to press the 'Yes' response key. There was no minimum or maximum scores since it was a time-based assessment. The software measured the speed of accurate responses to each event. In this outcome measure, speed of performance of participants (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Lower scores indicated better performance.|Baseline (pre-dose at Day 1), Week 12|"Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and ‘n’ signifies number of participants evaluated for specific categories for each arm respectively."|||log10 milliseconds||Standard Deviation|Mean
2681820|NCT01389596|Other Pre-specified|Number of Adverse Events by Severity|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild: AEs does not interfere with participant's usual function b) moderate: AEs interferes to some extent with participant's usual function c) severe: AEs interferes significantly with participant's usual function.|Day 1 up to 7 days after last dose of study drug (up to 13 weeks)|Safety population included all randomized participants who took at least 1 dose of the study drug.|||events|||Number
2683023|NCT01380080|Secondary|Time to Initiation of TB Treatment by Week 96|Median time to TB treatment initiation by week 96|From study entry to week 96||2020-12-31|12/2020||||
2681815|NCT01389596|Other Pre-specified|Child Behaviour Checklist (CBCL): Total Problem Subscale Score in Participants Less Than 6 Years of Age|CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study|Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)|"Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and ‘n’ signifies number of participants evaluated for specific categories for each arm respectively."|||T scores||Standard Deviation|Mean
2681816|NCT01389596|Other Pre-specified|Child Behaviour Checklist (CBCL): Withdrawn Subscale Score in Participants Less Than 6 Years of Age|CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study|Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)|"Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and ‘n’ signifies number of participants evaluated for specific categories for each arm respectively."|||T scores||Standard Deviation|Mean
2681817|NCT01389596|Other Pre-specified|Child Behaviour Checklist (CBCL): Internalizing Subscale Score in Participants Less Than 6 Years of Age|CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study.|Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)|"Safety population included all randomized participants who took at least 1 dose of the study drug.Here, N signifies number of participants who were evaluable for this measure and ‘n’ signifies number of participants evaluated for specific categories for each arm respectively."|||T scores||Standard Deviation|Mean
2681818|NCT01389596|Other Pre-specified|Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories During Post Baseline Time Period|"C-SSRS (mapped to C-CASA):participant-rated questionnaire to assess suicidal ideation and suicidal behavior. For suicidal ideation and behaviour, data from C-SSRS was mapped to C-CASA codes 1, 2, 3, 4 and 7. C-SSRS assessed whether participant experienced the following: completed suicide (C-CASA code 1); suicide attempt (response of Yes on actual attempt) (C-CASA code 2); preparatory acts toward imminent suicidal behavior (ISB) (Yes on preparatory acts or behavior)(C-CASA code 3); suicidal ideation (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent) (C-CASA code 4); any self-injurious behavior with no suicidal intent (C-CASA code 7). Number of participants with positive response (response of yes) to C-SSRS (mapped to C-CASA categories 1, 2, 3, 4 and 7) during post baseline time period (Day 1 up to Week 13) were reported"|Day 1 up to Week 13|"Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure."|||participants|||Number
2681819|NCT01389596|Other Pre-specified|Number of Participants (6-16 Years of Age) With Positive Response to Columbia Suicide-Severity Rating Scale (C-SSRS) According to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories At Baseline|"The C-SSRS (mapped to C-CASA) is a participant-rated questionnaire to assess suicidal ideation and suicidal behavior. For suicidal ideation and behaviour, data from C-SSRS was mapped to C-CASA codes 1, 2, 3, 4 and 7. C-SSRS assessed whether participant experienced the following: completed suicide (C-CASA code 1); suicide attempt (response of Yes on actual attempt) (C-CASA code 2); preparatory acts toward imminent suicidal behavior (ISB) (Yes on preparatory acts or behavior)(C-CASA code 3); suicidal ideation (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent) (C-CASA code 4); any self-injurious behavior with no suicidal intent (C-CASA code 7). In this outcome, number of participants with positive response (response of yes) to C-SSRS (mapped to C-CASA categories 2, 3, 4 and 7) at baseline were reported."|Baseline (4 week prior to Day 1 of treatment)|"Safety population included all randomized participants who took at least 1 dose of the study drug. Here, N signifies number of participants who were evaluable for this outcome measure."|||participants|||Number
2681821|NCT01389596|Other Pre-specified|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to drug was assessed by the investigator. AEs included both serious and non-serious adverse events.|Day 1 up to 7 days after last dose of study drug (up to 13 weeks)|Safety population included all randomized participants who took at least 1 dose of the study drug.|||participants|||Number
2681822|NCT01389596|Other Pre-specified|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre- treatment state. AEs included both serious and non-serious adverse events.|Day 1 up to 7 days after last dose of study drug (up to 13 weeks)|Safety population included all randomized participants who took at least 1 dose of the study drug.|||participants|||Number
2681823|NCT01389596|Secondary|Percentage of Participants With at Least 50 Percent (%) or Greater Reduction From Baseline in 28-day Seizure Rate During the 12 Week Treatment Phase|Percentage of participants with 50 percent (%) or greater reduction from baseline in 28-day seizure rate during the 12 week treatment phase were reported. 28-day seizure rate for all partial onset seizures = ([number of seizures in the treatment phase] divided by [number of days in treatment phase minus {-} number of missing diary days in treatment phase])*28.|Day 1 up to Week 12|ITT population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment.|||percentage of participants|||Number
2681824|NCT01389596|Primary|Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During 12-Week Treatment Phase|"All partial onset seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all partial onset seizures = ([number of seizures in the treatment phase] divided by [number of days in treatment phase minus {-} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible 0 seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1)."|Day 1 up to Week 12|"ITT population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment. Here, Number of Participants Analyzed (N) signifies number of participants who were evaluable for this outcome measure."|||Seizures per 28 days||Standard Error|Least Squares Mean
2681825|NCT01389596|Primary|Log-Transformed 28-Day Seizure Rate For All Partial Onset Seizures During Baseline Phase|"All partial onset seizures experienced during baseline phase were recorded by the participants or their parents/legal guardian, in a daily seizure diary. 28-day seizure rate for all partial onset seizures = ([number of seizures in the baseline phase] divided by [number of days in baseline phase minus {-} number of missing diary days in baseline phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible 0 seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1)."|Baseline phase (up to 8 weeks prior to treatment phase [Day 1])|Intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study drug during the double-blind treatment phase and had a baseline and at least 1 follow-up efficacy assessment.|||Seizures per 28 days||Standard Deviation|Mean
2681826|NCT01389323|Secondary|Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), Treatment-related AEs, and Who Died|An AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. For analysis purpose, participants were assigned to following 4 race/ethnicity cohorts: Black/African American, White/Caucasian, Latino and Non-Latino. Some participants were represented in more than one race/ethnicity cohort.|From first dose to last dose plus 7 days (treatment period [TP]) through 48 weeks after the end of TP (follow-up period [FUP])|"All treated participants for TP and all follow-up participants for FUP. Here, n signifies the number of participants evaluable in their respective study periods."|||participants|||Number
2681827|NCT01389323|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Not Detected, at Specified Time Points|The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.|Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Weeks 12 and 24|All treated participants. Here, 'N' (number of participants analyzed) signifies number of participants evaluable at the specified time-points.|||percentage of participants||95% Confidence Interval|Number
2681840|NCT01389258|Secondary|Gingival Zenith Score|"Gingival zenith score measured from the gingival zenith to the incisal edge of the prosthetic crown with a periodontal probe to nearest 0.5 mm.~Presented as change from loading of permanent restoration to time of the 3-year follow-up visit."|Measured at implant loading and at the 3-year follow-up visit after loading.|40 subjects (42 implants) completed the 3-year follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).|||millimeter|implants|Standard Deviation|Mean
2681828|NCT01389323|Secondary|Percentage of Participants With Hepatitis C Virus (HCV) RNA Levels <Lower Limit of Quantitation (LLOQ), Target Detected or Target Not Detected, at Specified Time Points|The limit of detection for HCV RNA levels was 10 IU/mL and the LLOQ was 25 IU/mL. Data for post-treatment Weeks 36 and 48 were based on participants who had achieved virologic response (defined as HCV RNA levels <LLOQ, target not detected) at both Weeks 4 and 12, and completed 24 weeks of study treatment. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.|Weeks 1, 2, 4, 6, 8, 12; both Weeks 4 and 12; end-of-treatment (up to 48 weeks), or post-treatment Week 24|All treated participants. Here, 'N' (number of participants analyzed) signifies number of participants evaluable at the specified time-points.|||percentage of participants||95% Confidence Interval|Number
2681829|NCT01389323|Secondary|Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12) With rs12979860 Single Nucleotide Polymorphisms at Baseline in the Interleukin-28B Gene|SVR12 was defined as Hepatitis C Virus (HCV) RNA levels <lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.|Post-treatment Week 12|All treated participants. Here, 'n' signifies the number of participants evaluable in the specified category.|||percentage of participants||95% Confidence Interval|Number
2681830|NCT01389323|Primary|Percentage of Participants Achieving Sustained Virologic Response at Post-treatment Week 12 (SVR12)|SVR12 was defined as Hepatitis C Virus (HCV) RNA levels <lower limit of quantitation (LLOQ), (target detected or target not detected) at Post-treatment Week 12. The limit of detection for HCV RNA was 10 IU/mL and the LLOQ was 25 IU/mL. For analysis purpose, participants were assigned to following 3 race/ethnicity cohorts: Black/African American, Latino, and White non-Latino. Some participants were represented in more than one race/ethnicity cohort.|Post-treatment Week 12|All treated participants. Modified intent-to-treat analysis (participants meeting the response criteria / all treated participants) was performed for Black/African American and Latino cohorts.|||percentage of participants||95% Confidence Interval|Number
2681831|NCT01389284|Secondary|Global Assessment of the Investigational Product as a Pain Reliever|Global assessment of investigational product as a pain reliever was rated on a 5-point categorical scale: 0 = poor, 1 = fair, 2 = good, 3 = very good, 4 = excellent|24 hours postdose or immediately before the first intake of rescue medication|Intent-to-treat (ITT)|||Participants|||Number
2681832|NCT01389284|Secondary|Number of Times the Participants Took Rescue Medication Over the 24-hour Period||24 hours postdose|Intent-to-treat (ITT)|||Rescue medication intakes||Standard Deviation|Mean
2681833|NCT01389284|Secondary|Cumulative Percentage of Participants Who Took Rescue Medication||At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose|Intent-to-treat (ITT)|||Percentage of participants|||Number
2681834|NCT01389284|Secondary|Median Time to First Intake of Rescue Medication|Time to first use of rescue medication was estimated using Kaplan-Meier method and analyzed by a logrank test stratified by baseline pain intensity. If at least 50% of subjects in a treatment group took rescue medication, the median time to first rescue was determined for that treatment group.|Up to 24 hours postdose|Intent-to-treat (ITT)|||Hours||Full Range|Median
2681835|NCT01389284|Secondary|Pain Relief From Initial Dose|Pain Relief was evaluated using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief|At 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose|Intent-to-treat (ITT)|||Score on the scale||Standard Deviation|Mean
2681836|NCT01389284|Secondary|Pain Intensity Differences (PIDs) by Time From Initial Dose|Pain intensity was evaluated using a 4-point Categorical Pain Intensity Rating Scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe|At 0, 0.25, 0.5, 0.75, 1, 2, 3, 4 ,5 ,6, 8, 12, 16, 20 and 24 hours postdose|Intent-to-treat (ITT)|||Score on the scale||95% Confidence Interval|Mean
2681837|NCT01389284|Secondary|Summed, Time-weighted Total Pain Relief Scores (TOTPARs)|TOTPARs were derived by multiplying the pain relief score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over the specified interval. Pain Relief was evaluated at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours postdose, using the 5-point overall pain relief scale: 0 = No relief, 1 = A little relief, 2 = Some relief, 3 = A lot of relief, 4 = Complete relief. The possible total score ranges of TOTPARs are: TOTPAR0-6: 0 to 18, TOTPAR0-8: 0 to 24, TOTPAR0-12: 0 to 36, TOTPAR0-16: 0 to 48, TOTPAR0-24: 0 to 72, TOTPAR16-24: 0 to 24.|0-6, 0-8, 0-12, 0-16, 0-24, and 16-24 hours postdose|Intent-to-treat (ITT)|||Score on the scale||95% Confidence Interval|Mean
2681838|NCT01389284|Secondary|Summed, Time-weighted Pain Intensity Differences (SPID)|Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total possible score ranges of SPIDs are SPID0-6: -6 to 18, SPID0-8: -8 to 24, SPID0-12: -12 to 36, SPID0-16: -16 to 48, SPID16-24: -8 to 24. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief.|0-6, 0-8, 0-12, 0-16 and 16-24 hours postdose|Intent-to-treat (ITT)|||Score on the scale||95% Confidence Interval|Mean
2681839|NCT01389284|Primary|Summed, Time-weighted Pain Intensity Difference From 0 to 24 Hours Postdose (SPID0-24)|SPID0-24 was calculated by multiplying the pain intensity difference score at each post-dose timepoint by the duration (in hours) since the preceding timepoint and then summing these values over 0 to 24 hours. Pain intensity was measured at baseline, 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8, 12, 16, 20 and 24 hours using the 4-point categorical pain intensity scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. SPID0-24 can vary from -24 to 72. The positive SPID value indicates improvement of pain relief. The higher the SPID value, the more improvement of pain relief.|From 0 to 24 hours post-dose|Intent-to-treat (ITT)|||Score on the scale||Standard Error|Mean
2681841|NCT01389258|Secondary|Presence of Plaque|Occurence of plaque around the study implant. Presented as proportion of implants that show presence of plaque at time of the 3-year follow-up visit.|Measured at the 3-year follow-up visit after implant loading.|40 subjects (42 implants) completed the 3-year follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).|||implants|implants||Count of Units
2681842|NCT01389258|Secondary|Condition of the Periimplant Mucosa by Assessment of Bleeding on Probing (BoP).|Condition of the periimplant mucosa by assessment of Bleeding on Probing (BoP). Presented as % of implants that show presence of bleeding on probing at time of the 3-year follow-up visit.|Measured at implant loading and at the 3-year follow-up visit after loading.|40 subjects (42 implants) completed the 3-year follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).|||implants|implants||Count of Units
2681843|NCT01389258|Secondary|Condition of the Periimplant Mucosa by Assessment of Probing Pocket Depth (PPD).|"Change in pocket depth expressed in millimeters at time of the 3 years follow-up visit, compared to values obtained at delivery of permanent restoration, i.e. loading (baseline).~Negative value = increased pocket depth."|Measured at implant loading and at the 3-year follow-up visit after loading.|40 subjects (42 implants) completed the 3 years follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).|||millimeter|Implants|Standard Deviation|Mean
2681844|NCT01389258|Secondary|Marginal Bone Level Alteration|"Marginal Bone Level (mm) determined from radiographs and expressed as a difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant.~Marginal Bone Level expressed in millimeters obtained at the 3-year follow-up visit compared to values obtained at delivery of the temporary restoration i.e. loading (baseline)."|Measured at the 3-year follow-up visit after implant loading.|40 subjects (42 implants) completed the 3-year follow-up visit. Protocol deviations were excluded (9 subjects, 10 implants), giving a per-protocol analysis population of 31 subjects (32 implants).|||millimeter|Implants|Standard Deviation|Mean
2681845|NCT01389258|Secondary|Implant Stability|Implant stability evaluated clinically/manually (recorded as stable yes/no).|Measured at the 3-year follow-up visit after implant loading.|40 subjects (42 implants) completed the 3-year follow-up visit. Analysis of implant stability was performed on the All Patients Treated (APT) population.|||implants|implants||Count of Units
2681846|NCT01389258|Primary|Implant Survival|Implant survival rate evaluated clinically and radiographically.|Measured at the 3-year follow-up visit after implant loading.|"Intention to treat (ITT), including all participants that received at least one implant, a total of 45 subjects (47 implants).~A total of 5 subjects (5 implants) had been lost to follow-up at time of the 3-year follow-up visit, giving an overall number of 40 subjects (42 implants) as basis for the analysis of three year survival rate."|||Implants|Implants||Count of Units
2681847|NCT01389128|Secondary|Number of Participants With:|Number and type of maternal complications as reported in medical chart|10 hours||||Participants|||Count of Participants
2681848|NCT01389128|Secondary|Number of Participants Whose Neonates Had:|Number and type of neonatal complications as reported in medical chart|10 hours||||Participants|||Count of Participants
2681849|NCT01389128|Secondary|Type of Delivery|Type of delivery at the end of the active phase of labor.|10 hours||||Participants|||Count of Participants
2681850|NCT01389128|Secondary|Number of Women Who Received Pharmacological Analgesia|Determine the number of women who where submitted to pharmacological analgesia, either prescribed by the attending physician ou requested by the patient herself.|10 hours||||Participants|||Count of Participants
2681851|NCT01389128|Secondary|Moment That Women Requested Analgesia During the Active Phase of Labor|Mean uterine cervical dilation at the moment the patient requested analgesia for pain relief. Data obtained from medical record|10 hours||||centimeter||Standard Deviation|Mean
2681852|NCT01389128|Secondary|Evolution of Labor|Amount of minutes, from admission to labor.|10 hours||||minutes||Standard Deviation|Mean
2681853|NCT01389128|Primary|Pain Relief|"The Visual Analogue Scale - VAS - was used to measure the intensity of the pain described by the patients during the study. The patient was requested do mark a dot in a straight line, measuring 100mm, being a 0 (Zero) no pain and 100 the most intense pain. The researcher then would measure the estimated pain intensity in millimeters. The pain intensity was measured in all three phases before and after each procedure assigned to each group. The phases and their respective procedures were:~Phase I: 4-5cm of cervical dilation (pelvic mobility in exercise ball)~Phase II: 5-6cm of cervical dilation (lumbosacral massage)~Phase III: 7cm or higher cervical dilation (warm shower)"|ten hours||||millimeters||Standard Deviation|Mean
2681854|NCT01389102|Primary|Mean Change the Severity of Moderate to Severe Vasomotor Symptoms|"Patients completed a daily diary to record the number of mild, moderate and severe vasomotor symptoms experienced each day.~Mild, moderate and severe were defined as follows:~Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity Severity of hot flushes was measured on a scale of none = 0, mild = 1, moderate = 2 and severe = 3."|baseline to week 12 (12 weeks)||||Scores on a scale||Standard Deviation|Mean
2681855|NCT01389102|Primary|Mean Change in the Number of Moderate to Severe Vasomotor Symptoms Per Day|"Patients completed a daily diary to record the number of mild, moderate and number of moderate or severe vasomotor symptoms [hot flushes and sweating] experienced each day.~Mild, moderate and severe hot flushes and sweating were defined as follows:~Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity"|baseline to week 12||||Vasomotor symptoms per day||Standard Deviation|Mean
2681856|NCT01389076|Secondary|Number of Participants That Experienced SAEs During Treatment.||Up to week 13||||participants|||Number
2681857|NCT01389076|Secondary|Median Progression Free Survival (PFS) Time|The median time patients survived without progression.|2 Years|Due to the withdrawal of Bexxar by the manufacture and failure to find another supplier, the trial was abandoned and follow-up scans were not obtained. Therefore only survival is known. Progression information is not available.||||||
2681858|NCT01389076|Secondary|The Percentage of Participants Alive at 2 Years|Overall survival was examined at 2 years|2 years||||percentage of participants|||Number
2681859|NCT01389076|Secondary|Percentage of Participants That Respond to Treatment|"The overall response rate (PR [partial response] + CR [complete response]) was determined.~Partial response is defined as the regression of measurable disease with no new sites of disease.~Complete response is defined as the disappearance of all evidence of disease."|2 years||||percentage of participants||95% Confidence Interval|Number
2681860|NCT01389076|Primary|Rate of Early Onset HAMA (Human Anti-mouse Antibody) Conversion Following Treatment|The percentage of patients that experience early onset HAMA conversion following treatment. Early-onset HAMA is defined as antimouse antibody levels (in blood serum) of at least 5 times the level of detection, occurring at or prior to the 7th week of I-131 tositumomab therapy.|7 weeks||||percentage of participants||95% Confidence Interval|Number
2681861|NCT01388985|Secondary|Number of Participants Experiencing Serious Adverse Events|Number of participants experiencing a Serious adverse event within 28 days after initial and booster vaccinations|28 days after initial and booster vaccination||||Participants|||Count of Participants
2681862|NCT01388985|Secondary|Number of Particpants Experiencing Adverse Events|Number of participants experiencing Adverse events within one week after initial and booster vaccinations|One week after initial and booster vaccination||||Participants|||Count of Participants
2681863|NCT01388985|Secondary|Number of Particpants With a Rabies Serology More Than 10IU/ml After Primary and Booster Vaccination|Number of participants that have a Rabies serology more than 10 IU/ml on day 35 after primary vaccination, and after booster vaccination.|Day 35 after primary (initial) vaccination, and after booster vaccination||||Participants|||Count of Participants
2681864|NCT01388985|Secondary|Number of Participants With a Rabies Serology More Than 0.5IU/ml After Primary Vaccination|Number of participants that have a Rabies serology more than 0,5 IU/ml on day 35 after primary vaccination.|Day 35 after primary (initial) vaccination||||Participants|||Count of Participants
2681865|NCT01388985|Primary|Number of Participants With a Boostability of the Rabies Antibodies After Booster Vaccination|The primary endpoint is the number of particpants with a boostability of the rabies antibodies on day 7 after booster vaccination, carried out at years 1 to 3 after initial vaccination. A rabies serology value of more than 0,5 IU/ml (international unit/milliliter) on day 7 after booster vaccination is considered to be protective. Subjects showing this serology value at day 7 are considered to be boostable.|Day 7 after booster vaccination|From the total number of participants that completed the study (200 in the standard vaccination schedule and 211 in het accelerated vaccination schedule), not all were included in het per protocol analysis. 15 participants were excluded from the standard vaccination schedule group and 28 were excluded from the accelerated schedule group.|||Participants|||Count of Participants
2681866|NCT01388946|Secondary|Chronic Pain|Number and incidence of patients with persisting pain (burning pain, loss of sensation) three month postoperatively|three months|Below the number of patients with pain three months postoperatively. For the chronic pain assessment in the control group we had two dropouts as contact for two patients was not feasible.|||Number of participants|||Number
2681867|NCT01388946|Secondary|Chronic Pain|Number and incidence of patients with persisting pain (burning pain, loss of sensation) one month postoperatively|one month postoperatively|Below the number of patients with pain one month postoperatively For the chronic pain assessment in the control group we had two dropouts as contact for two patients was not feasible.|||number of participants|||Number
2681868|NCT01388946|Secondary|Pain Scores During Cough 48 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|48 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient in this group presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough 48 h postoperatively|||mm||Standard Deviation|Mean
2681869|NCT01388946|Secondary|Pain Scores During Cough 8 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|8 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) 8 h postoperatively|||mm||Standard Deviation|Mean
2681870|NCT01388946|Secondary|Pain Scores During Cough 4 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|4 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough 4 h postoperatively|||mm||Standard Deviation|Mean
2681871|NCT01388946|Secondary|Pain Scores During Cough 2 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|2 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough 2 h postoperatively|||mm||Standard Deviation|Mean
2681872|NCT01388946|Secondary|Pain Scores During Cough in the PACU|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|PACU|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) during cough in PACU|||mm||Standard Deviation|Mean
2681873|NCT01388946|Secondary|Pain Scores at Rest 48 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|48 h|50 patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. 1 patient in this group presented ileus after the first 24 h assessment, remaining 49 patients for assessment at 48 hours postoperatively Below are the VAS values (mean and standard deviation) at rest 48 hours postoperatively|||mm||Standard Deviation|Mean
2681874|NCT01388946|Secondary|Pain Scores at Rest 24 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|24h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) at rest 24 h postoperatively|||mm||Standard Deviation|Mean
2681875|NCT01388946|Secondary|Pain Scores at Rest 8 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|8 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) at rest 8 h postoperatively|||mm||Standard Deviation|Mean
2681876|NCT01388946|Secondary|Pain Scores at Rest 4 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|4 h|Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery Below are the VAS values (mean and standard deviation) at rest 4 h postoperatively|||mm||Standard Deviation|Mean
2681877|NCT01388946|Secondary|Pain Scores at Rest 2 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|2 h postoperatively|"Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery.~Below are the VAS values (mean and standard deviation) 2 h postoperatively at rest"|||mm||Standard Deviation|Mean
2681878|NCT01388946|Secondary|Pain Scores in the Postoperative Care Unit (PACU) at Rest|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|in PACU|Below is the mean and standard deviation of the VAS scores in PACU at rest Fifty patients in the Ropivacaine group were analyzed for the primary and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery|||mm||Standard Deviation|Mean
2681879|NCT01388946|Primary|VAS Score Changes ( Cough) During 24 h Postoperatively|Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.|24 h|Fifty patients in the Ropivacaine group were analyzed for the primary (VAS score at cough) and secondary outcomes 24 hours postoperatively. One patient presented ileus after the first 24 h and was not assessed for pain 48 h after surgery|||mm||Standard Deviation|Mean
2681880|NCT01388920|Secondary|Plasma Glucose|Changes from baseline in fasting blood glucose|6 months|||||||
2681881|NCT01388920|Secondary|COPD Exacerbations|Frequency and severity of COPD exacerbations|6 months|||||||
2681882|NCT01388920|Secondary|Adverse Events|Number and percentage of subjects with adverse events|6 months|||||||
2681883|NCT01388920|Secondary|Change From Baseline in Patient-reported Outcomes at 6 Months||6 months|||||||
2681884|NCT01388920|Secondary|Change From Baseline in Peripheral Muscle Strength at 6 Months||6 months|||||||
2681885|NCT01388920|Secondary|Change From Baseline in Exercise Capacity at 6 Months||6 months|||||||
2681886|NCT01388920|Primary|Change From Baseline in Lean Body Mass at 6 Months|The primary objective of the study was to evaluate the effect of tesamorelin on lean body mass by Dual-energy X-ray absorptiometry (DXA) scan|6 months|The primary objective of the study was the change in lean body mass between baseline and Month 6. However, the study was halted approximately 1 month after patient enrollment.||||||
2681887|NCT01388907|Secondary|mAFS Abdominopelvic Adhesion Score|mAFS abdominopelvic adhesion score in 23 sites (at the anterior caudal peritoneum; parietocolic gutter right; right and left colon; right and left anterior cranial peritoneum; rectosigmoid; omentum; small intestine; anterior and posterior uterus; posterior cul-de-sac; right and left ovaries [internal and lateral sides], pelvic side walls, ovarian fossae, tubes, and bulbs). It ranges from 0 (best possible outcome) to 16 (worse possible outcome).|10 to 20 weeks post surgery||||units on a scale||Standard Deviation|Mean
2681888|NCT01388907|Secondary|Adnexal Adhesions|Adnexal Adhesions were assessed by AFS score. AFS (= American Fertility Society) score was developed in 1980's by the American Fertility Society in an effort to address needs for a classification scheme for adnexal adhesions suspected to be associated with infertility. 4 anatomic sites evaluated: R-tube; R-ovary; L-tube; L-ovary. Final AFS score for a patient is the score of the side with lower summed score. The higher score, representing the side with the higher adhesion burden, is dropped; Score AFS is from 0 (best possible outcome) to 32 (worse possible outcome).|10 to 20 weeks post surgery||||units on a scale||Standard Deviation|Mean
2681889|NCT01388907|Secondary|Fertility|Fertility was assessed by pregnancy and deliveries rates at 3 years.|3 years||||participants|||Number
2681890|NCT01388907|Primary|Number of Patients With Adhesions to Uterine Scars|"The primary endpoint was the assessment of adhesions to uterine scars and comprised the incidence (expressed per patient and per uterine scar), extent, and severity of adhesions observed during the second-look laparoscopy performed 10 to 20 weeks after the myomectomy.~This assessment was made by the surgeon (investigator) on the one hand and by two independent surgeons who reviewed the video recordings on the other hand."|10 to 20 weeks post surgery|Two patients in group Prevadh group were withdrawn from the study, at 1 and 6 days post-myomectomy. One patient was re-operated for compress removal in Prevadh group and was excluded. Two patients in group Lactate Ringer group were withdrawn from the study, at 1 and 6 days post-myomectomy.|||participants|||Number
2681891|NCT01388816|Secondary|Changes in Other Lipids and Apolipoproteins|Change from baseline (LOCF, ITT population)|28 days|ITT with LOCF|||percentage change from baseline||95% Confidence Interval|Least Squares Mean
2681892|NCT01388816|Secondary|Changes in CETP Inhibition in Plasma|Percent change from baseline in CETP Inhibition|28 days|ITT with LOCF|||percentage from baseline||95% Confidence Interval|Least Squares Mean
2681893|NCT01388816|Secondary|To Evaluate Trough Levels of DRL-17822 in Plasma|Trough levels of DRL-17822 in plasma after 28 days of treatment|28 days||||ng/mL||Standard Deviation|Mean
2681894|NCT01388816|Secondary|Changes in Vital Signs Including Blood Pressure|Vital sign abnormalities reported as treatment-emergent AEs|28 days|ITT/Safety Population|||participants|||Number
2681895|NCT01388816|Secondary|Safety and Tolerability of DRL-17822|Incidence of treatment-related adverse events|28 days|Safety/ITT Population|||participants|||Number
2684379|NCT01368497|Secondary|Proportion of Participants With HBV DNA < 20 IU/mL||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
2681897|NCT01388790|Secondary|Median Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments|The PFS time is defined as the duration from start of treatment until radiological progression (based on RECIST v 1.0 criteria) or death due to any cause within 60 days of the last tumor assessment or start of treatment. Participants without event are censored on the date of last tumor assessment.|Time from start of treatment to disease progression, death or last tumor assessment, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012)|ITT population included all participants who received at least one dose of study treatment.|||months||95% Confidence Interval|Median
2681898|NCT01388790|Primary|Best Overall Response (BOR) Rate - Independent Review Committee (IRC) Assessments|The best overall response rate is defined as the percentage of participants having achieved confirmed complete response plus partial response as the best overall response according to radiological assessments (based on Response Evaluation Criteria in Solid Tumors version 1.0 [RECIST v 1.0] criteria).|Evaluations were performed every 6 weeks until disease progression, reported between day of first participant treated, that is July 2011, until cut-off date, (14 August 2012)|ITT population included all participants who received at least one dose of study treatment.|||percentage of participants||95% Confidence Interval|Number
2681899|NCT01388777|Primary|Rate of Complete Tumor Ablation|The rate of complete tumor ablation in the target lesion will be evaluated by pathologic review of the surgical specimen.|From cryoablation through 30 days from surgery||||Participants|||Count of Participants
2681900|NCT01388647|Other Pre-specified|Dose Limiting Toxicity (DLT)|DLT is defined as grade 4 thrombocytopenia; grade 4 anemia; grade 4 neutropenia lasting > 5 days; or any grade 3 or 4 non-hematologic toxicity occurring during Cycle 1 which is attributable to eribulin, carboplatin, trastuzumab or the combination, or the inability to deliver all three agents at the assigned dose and scheduled time during Cycle 1.The following events are excluded from the DLT definition: grade 3 nausea and/or vomiting responsive to antiemetics; grade 3 fever or infection; grade 3 diarrhea responsive to antidiarrheal therapy.|Approximately 22 days from study treatment start, per subject||||participants|||Number
2681901|NCT01388647|Other Pre-specified|Maximum Tolerated Dose (MTD) of Eribulin in Combination With Carboplatin and Trastuzuamb|The MTD is defined as the dose at which <= 1 of 6 subjects experience DLT (Dose Limiting Toxicity) and above which >= 2 of 6 subjects experience DLT.|Approximately 22 days from study treatment start, per subject|The MTD of ECH as neoadjuvant therapy for HER2+ breast cancer was determined per protocol definitions; however, due to the combination of increased hematologic toxicity and possible reduced efficacy, Phase II of this trial was not initiated.|||mg/m^2|||Number
2681902|NCT01388647|Secondary|Clinical Response|Clinical assessment of response will be performed 3 weeks after completion of study treatment. The treating physician will assess clinical response using physical examination and radiologic evaluation. Clinical response options are complete response (no invasive tumor in breast and lymph nodes), partial response (> 50% reduction in longest diameter of pretreatment tumor), no response (< 50% response to 10% growth of tumor as determined by longest diameter of pretreatment tumor size), and progression.|Assessed prior to definitive surgery, approximately 18 weeks from study treatment start.||||percentage of participants||95% Confidence Interval|Number
2681903|NCT01388647|Primary|Pathologic Response|Definitive surgery will be performed 3 to 8 weeks after completion of study treatment. The pathology report will be scored for pathologic response: complete pathologic response (no invasive cancer in breast or lymph nodes; residual DCIS or LCIS is acceptable), partial pathologic response (residual invasive cancer in breast and/or lymph nodes), or no response (pathologic staging is equal to or worse than pretreatment clinical staging).|Assessed at time of definitive surgery, approximately 21-26 weeks from study treatment start||||percentage of participants||95% Confidence Interval|Number
2681904|NCT01388543|Primary|Day 7 Atazanavir Oral Clearance|Measure atazanavir oral clearance in genetically-determined CYP3A5 expressors versus CYP3A5 non-expressors|Day 7||||L/h/kg||95% Confidence Interval|Geometric Mean
2681905|NCT01388530|Secondary|Attention Network Task - Incongruent Reaction Time|"Laboratory measure of response inhibition. The measure assessed the reaction time in milliseconds (ms) using the Attention Network Task (ANT), which is a computerized test designed to evaluate the efficiency of an attention network.~Outcome measure represents a change from Baseline at Week 8 for the ANT - Incongruent reaction time. Lower reaction time is consider a better outcome."|Baseline and Week 8.|Participants with data at baseline and week 4. We included participants who completed 4 weeks of treatment, but comparison is based on Week 8 vs. baseline.|||milliseconds (ms).||Standard Deviation|Mean
2681906|NCT01388530|Secondary|Conners Global Index - Parent|"A standard, parent completed measure of ADHD symptoms.~Scale range from 0 (best) to 27 (worst).~Unit of Measure - units on a scale.~Outcome value reflects change from baseline at endpoint (Week 8)."|Baseline and Week 8.|Participants with data at baseline and week 4. We required 4 weeks treatment to include in analysis, but analysis is based on comparison of baseline and week 8.|||units on a scale||Standard Deviation|Mean
2681907|NCT01388530|Secondary|Clinical Global Impression - Improvement (CGI-I)|"A global measure of clinical improvement compared with baseline.~A standard clinical trials rating scale with value from 1 (very much improved) to 7 (very much worse).~Unit of measure - percentage improved based on CGI-I scores of 1 and 2 versus all others."|Week 8|Participants with data at baseline and week 4. As with the ADHD-RS, we included participants with at least 4 weeks of treatment, but outcome was assessed at Visit 8 compared with baseline.|||percentage of improved|||Number
2681908|NCT01388530|Primary|ADHD-IV Rating Scale (ADHD-RS)|"A standard, frequently used, clinician completed measure of Diagnostic and Statistical Manual -IV (DSM-IV) ADHD symptoms.~Scale ranges from 0 (best) to 54 (worst).~Unit of Measure - units on a scale.~Outcome value reflects change from baseline at endpoint (Week 8) in ADHD-RS."|Baseline and Week 8.|Participants with data at baseline and week 4. We included participants who participated in 4 weeks of treatment, but change comparison is baseline vs. week 8.|||units on a scale||Standard Deviation|Mean
2681938|NCT01387815|Secondary|Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6|"Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as yes, no, not done or missing."|Month 6|ITT population of participants who were available for assessment at this visit.|||participants|||Number
2681909|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Sex Hormone Binding Globulin|Normal range for this parameter was 28 to 146 nmol/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||nmol/L||Standard Error|Least Squares Mean
2681910|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Thyroid-Stimulating Hormone (TSH)|Normal range for this parameter was 0.35 to 5.5 mIU/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||mIU/L||Standard Error|Least Squares Mean
2681911|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Serum Random Total Cortisol|Normal range for this adrenal parameter was 85.6 to 618.2 nmol/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||nmol/L||Standard Error|Least Squares Mean
2681912|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Corticosteroid-Binding Globulin|Normal range for this adrenal parameter was 1906.448 to 4520.504 mg/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||mg/L||Standard Error|Least Squares Mean
2681913|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Endogenous Thrombin Potential (EPT)-Based Activated Protein-C (APC) Resistance|This hemostatic parameter is calculated by dividing the clotting time with APC by the clotting time without APC. Normal range for this measure was defined as a ratio of 0.32 to 1.79. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||ratio||Standard Error|Least Squares Mean
2681914|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Activated Partial Thromboplastin Time (APTT)-Based Activated Protein-C (APC) Resistance|This hemostatic parameter is calculated by dividing the clotting time with APC by the clotting time without APC. Normal range for this measure was defined as a ratio of 2.00 to 3.36. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||ratio||Standard Error|Least Squares Mean
2681915|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VIII|Normal range for this hemostatic parameter was 50% to 180%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||percentage of normal||Standard Error|Least Squares Mean
2681916|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VII|Normal range for this hemostatic parameter was 60% to 150%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||percentage of normal||Standard Error|Least Squares Mean
2681917|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor II Activity|Normal range for this hemostatic parameter was 70% to 150%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||percentage of normal||Standard Error|Least Squares Mean
2681918|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Antithrombin|Normal range for this hemostatic parameter was 75% to 130%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||percentage of normal||Standard Error|Least Squares Mean
2681919|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Protein C Activity|The normal range for this hemostatic parameter was 70% to 180%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||percentage of normal||Standard Error|Least Squares Mean
2681920|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Period in Protein S Total Antigen|The normal range for this hemostatic parameter was 50% to 147%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||percentage of normal 50% to 147%||Standard Error|Least Squares Mean
2681921|NCT01388491|Secondary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in D-Dimer|Normal range for this hemostatic parameter was 0 to 729 mcg/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||mcg/L||Standard Error|Least Squares Mean
2681922|NCT01388491|Primary|Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels|Normal range for this hemostatic parameter was 41 to 372 pmol/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.|Baseline through Month 6|Per-protocol (PP) population. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.|||pmol/L||Standard Error|Least Squares Mean
2681923|NCT01388361|Secondary|Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes|Corresponds to number of treatment emergent hypoglycaemic events from onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product. Confirmed hypoglycaemia was defined as the pool of severe hypoglycaemic episodes and minor episodes with a plasma glucose (PG) value < 3.1 mmol/L (56 mg/dL).|Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product.|The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator|||events|||Number
2681924|NCT01388361|Secondary|Change From Baseline in Body Weight|Corresponds to the values of change in body weight in kilograms from baseline to week 26.|week 0, week 26|Both sets of FAS and NAS included all randomised and non-randomised subjects in the treatment period and missing data was imputed using LOCF. At baseline, the body weight values were missing for 1 subject in IDeg + Liraglutide arm from FAS and 3 subjects in NAS for IDeg arm.|||kg||Standard Deviation|Mean
2681925|NCT01388361|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG)|Values for change in FPG in mmol/L from baseline to week 26 of randomised period.|week 0, week 26|Both sets of FAS and NAS included all randomised and non-randomised subjects in the treatment period. The FPG values were missing for 7 subjects in FAS (2 subjects with IDeg+ liraglutide; 5 subjects with IDeg+IAsp arm) and 10 subjects in NAS for IDeg arm at baseline. The missing data was imputed using LOCF.|||mmol/L||Standard Deviation|Mean
2681926|NCT01388361|Primary|Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)|Values for change in HbA1c from baseline to 26 weeks of treatment period.|week 0, week 26|The FAS and NAS included all randomised and non-randomised subjects respectively, and missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2681927|NCT01388166|Secondary|Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From Baseline|The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 1 (baseline). Therefore, a positive change score reflects an improvement in the adherence.|12 months and baseline|This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results both at baseline and after 6 months.|||units on a scale||Standard Deviation|Mean
2684380|NCT01368497|Secondary|Proportion of Participants With HBV DNA ≤1000 IU/mL||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
2681928|NCT01388166|Secondary|Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From End of Educational Period After 6 Months.|The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 3. Therefore, a positive change score reflects an improvement in the adherence.|6 months and 12 months|This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results after 6 and 12 months.|||units on a scale||Standard Deviation|Mean
2681929|NCT01388166|Primary|Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From Baseline|The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 3 minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.|Baseline and 6 months|This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results both at baseline and after 6 months.|||units on a scale||Standard Deviation|Mean
2681930|NCT01387815|Secondary|Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24|"Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as yes, no, not done or missing."|Month 24|ITT population of participants who were available for assessment at this visit.|||participants|||Number
2681931|NCT01387815|Secondary|Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18|"Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as yes, no, not done or missing."|Month 18|ITT population of participants who were available for assessment at this visit.|||participants|||Number
2681932|NCT01387815|Secondary|Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12|"Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as yes, no, not done or missing."|Month 12|ITT population of participants who were available for assessment at this visit.|||participants|||Number
2681933|NCT01387815|Secondary|Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6|"Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as yes, no, not done or missing."|Month 6|ITT population of participants who were available for assessment at this visit.|||participants|||Number
2681934|NCT01387815|Secondary|Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3|"Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as yes, no, not done or missing."|Month 3|ITT population of participants who were available for assessment at this visit.|||participants|||Number
2681935|NCT01387815|Secondary|Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24|"Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as yes, no, not done or missing."|Month 24|ITT population of participants who were available for assessment at this visit.|||participants|||Number
2681936|NCT01387815|Secondary|Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18|"Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as yes, no, not done or missing."|Month 18|ITT population of participants who were available for assessment at this visit.|||participants|||Number
2681937|NCT01387815|Secondary|Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12|"Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as yes, no, not done or missing."|Month 12|ITT population of participants who were available for assessment at this visit.|||participants|||Number
2683398|NCT01376362|Secondary|Change in Intraocular Pressure (IOP) in the Fellow Eye at Week One Compared to Baseline|Intraocular pressure was recorded using a standard Goldmann applanation tonometer, a device for the measurement of intraocular pressure between 0 to 78 mm Hg.|Baseline and 1 Week||||mm Hg||Standard Deviation|Mean
2681939|NCT01387815|Secondary|Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3|"Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as yes, no, not done or missing."|Month 3|ITT population of participants who were available for assessment at this visit.|||participants|||Number
2681940|NCT01387815|Secondary|Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24|Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.|Month 24|ITT population|||doses||Standard Deviation|Mean
2681941|NCT01387815|Secondary|Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18|Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.|Month 18|ITT population|||doses||Standard Deviation|Mean
2681942|NCT01387815|Secondary|Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12|Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.|Month 12|ITT population|||doses||Standard Deviation|Mean
2681943|NCT01387815|Secondary|Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6|Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.|Month 6|ITT population|||doses||Standard Deviation|Mean
2681944|NCT01387815|Secondary|Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3|Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.|Month 3|ITT population|||doses||Standard Deviation|Mean
2681945|NCT01387815|Secondary|Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24|Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.|Month 24|ITT population|||doses||Standard Deviation|Mean
2681946|NCT01387815|Secondary|Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18|Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.|Month 18|ITT population|||doses||Standard Deviation|Mean
2681947|NCT01387815|Secondary|Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12|Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.|Month 12|ITT population|||doses||Standard Deviation|Mean
2682091|NCT01387607|Secondary|Number of Treatment-Emergent Adverse Events (TEAEs) Categorized by Severity|A mild Adverse Event (AE) was an AE that did not interfere with participant's usual function. A moderate AE was an AE that interfered participant's usual function to some extent. A severe AE was an AE that interfered significantly with participant's usual function.|Baseline to Follow up (Day 105)|The Safety Analysis Set was defined as all randomized participants who received at least 1 dose of study medication.|||Events|||Number
2681948|NCT01387815|Secondary|Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6|Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.|Month 6|ITT population|||doses||Standard Deviation|Mean
2681949|NCT01387815|Secondary|Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3|Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.|Month 3|ITT population|||doses||Standard Deviation|Mean
2681950|NCT01387815|Secondary|Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 24|Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.|Month 24|ITT population|||sessions||Standard Deviation|Mean
2681951|NCT01387815|Secondary|Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 18|Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.|Month 18|ITT population|||sessions||Standard Deviation|Mean
2681952|NCT01387815|Secondary|Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 12|Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.|Month 12|ITT population|||sessions||Standard Deviation|Mean
2681953|NCT01387815|Secondary|Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 6|Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.|Month 6|ITT population|||sessions||Standard Deviation|Mean
2681954|NCT01387815|Secondary|Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 3|Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.|Month 3|ITT population|||sessions||Standard Deviation|Mean
2681955|NCT01387815|Secondary|Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24|Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.|Month 24|ITT population|||doses||Standard Deviation|Mean
2681956|NCT01387815|Secondary|Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18|Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.|Month 18|ITT population|||doses||Standard Deviation|Mean
2682142|NCT01387269|Primary|Change in Handgrip Strength|Change in Handgrip Strength (HGS) of the non-dominant hand from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.|Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks|Intent-to-Treat Population. Some patients in the ITT population were excluded from the primary LBM/HGS analysis (i.e., multiple imputations/ranking method) if they survived to Week 12 but missed their baseline covariates including LBM, HGS, or ECOG OR had Week 6 and Week 12 outcomes that were outside the visit windows.|||kg||95% Confidence Interval|Median
2681957|NCT01387815|Secondary|Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12|Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.|Month 12|ITT population|||doses||Standard Deviation|Mean
2681958|NCT01387815|Secondary|Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6|Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.|Month 6|ITT population|||doses||Standard Deviation|Mean
2681959|NCT01387815|Secondary|Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3|Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.|Month 3|ITT population|||doses||Standard Deviation|Mean
2681960|NCT01387815|Secondary|HCRU: Cost of Payments for Transportation at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||dollars||Standard Deviation|Mean
2681961|NCT01387815|Secondary|HCRU: Cost of Payments for Transportation at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||dollars||Standard Deviation|Mean
2681962|NCT01387815|Secondary|HCRU: Cost of Payments for Transportation at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||dollars||Standard Deviation|Mean
2681963|NCT01387815|Secondary|HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||dollars||Standard Deviation|Mean
2682143|NCT01387269|Primary|Change in Lean Body Mass|Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.|Change in Lean Body Mass from Baseline Over 12 Weeks|Intent-to-Treat Population. Some patients in the ITT population were excluded from the primary LBM/HGS analysis (i.e., multiple imputations/ranking method) if they survived to Week 12 but missed their baseline covariates including LBM, HGS, or ECOG OR had Week 6 and Week 12 outcomes that were outside the visit windows.|||kg||95% Confidence Interval|Median
2681964|NCT01387815|Secondary|HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||dollars||Standard Deviation|Mean
2681965|NCT01387815|Secondary|HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||dollars||Standard Deviation|Mean
2681966|NCT01387815|Secondary|HCRU: Cost of Payments for Medical Devices at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||dollars||Standard Deviation|Mean
2681967|NCT01387815|Secondary|HCRU: Cost of Payments for Medical Devices at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||dollars||Standard Deviation|Mean
2681968|NCT01387815|Secondary|HCRU: Cost of Payments for Medical Devices at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||dollars||Standard Deviation|Mean
2681969|NCT01387815|Secondary|HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||dollars||Standard Deviation|Mean
2682128|NCT01387516|Primary|Number of Subjects Who Were Verified Abstinent From Smoking Using CO Levels and Cotinine in the Saliva|A smokelyzer and a saliva sample are used to get information on CO levels and cotinine in the saliva as biochemical markers for our research. These levels will determine if the participant is verified as being abstinent from smoking during the week before collection. Biochemical markers are collected at Baseline, 3 and 6 month follow up assessments.|6 months post release|All participants that supplied biochemical markers. If a participant was lost at 3 month follow up; Baseline biochemical markers were included in analysis. When a participant was lost at 6 month follow up, 3 month biochemical markers were used in analysis. 1 participant in the RT/SHP arm never submitted biochemical markers and is not included.|||Participants|||Count of Participants
2681970|NCT01387815|Secondary|HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||dollars||Standard Deviation|Mean
2681971|NCT01387815|Secondary|HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||dollars||Standard Deviation|Mean
2681972|NCT01387815|Secondary|HCRU: Cost of Payments to Healthcare Professionals at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||dollars||Standard Deviation|Mean
2681973|NCT01387815|Secondary|HCRU: Cost of Payments to Healthcare Professionals at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||dollars||Standard Deviation|Mean
2681974|NCT01387815|Secondary|HCRU: Cost of Payments to Healthcare Professionals at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||dollars||Standard Deviation|Mean
2681975|NCT01387815|Secondary|HCRU: Cost of Payment for Over the Counter Medications at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||dollars||Standard Deviation|Mean
2682129|NCT01387516|Primary|Cigarette Use, Average # of Cigarettes Per Smoking Day.|Using a 60-day TLFB we collected the average number of cigarettes smoked per smoking day at 6-month follow-ups|6 months post release|Participants who received both individual (MI or RT) and group (CBT or SHP) treatment who received 6 month follow-up and who had at least one smoking day were included in this analysis. Non-smokers @ 6 month were excluded.|||days||Standard Deviation|Mean
2682130|NCT01387464|Primary|Mean Aqueous Humor Bromfenac Concentration||Approximately 3 hours post last dose|Per-Protocol Population|||ng/mL||Standard Deviation|Mean
2681976|NCT01387815|Secondary|HCRU: Cost of Payment for Over the Counter Medications at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||dollars||Standard Deviation|Mean
2681977|NCT01387815|Secondary|HCRU: Cost of Payment for Over the Counter Medications at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||dollars||Standard Deviation|Mean
2681978|NCT01387815|Secondary|HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population. Data not collected.||||||
2681979|NCT01387815|Secondary|HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||participants|||Number
2681980|NCT01387815|Secondary|HCRU: Number of Participants Admitted to the Intensive Care Unit (ICU) in the Past 4 Weeks at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||participants|||Number
2681981|NCT01387815|Secondary|HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||days||Standard Deviation|Mean
2682131|NCT01387347|Secondary|Number of Adverse Events as a Measure of Safety and Tolerability|The Adverse events, which will be followed, are: impairment of visual acuity, an increase in intraocular pressure (IOP), and an increase in corneal sensitivity in both eyes.|Throughout the study till Day 29|Intention to treat (ITT)|||Events|||Number
2682155|NCT01387139|Primary|Frequency of Adverse Events|We will record all adverse events during the sedation, and then perform a follow-up call to determine if any additional adverse events occured after discharge.|From enrollment through completion of follow-up, up to 7 days|Adverse events|||participants|||Number
2681982|NCT01387815|Secondary|HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||days||Standard Deviation|Mean
2681983|NCT01387815|Secondary|HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||days||Standard Deviation|Mean
2681984|NCT01387815|Secondary|HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||participants|||Number
2681985|NCT01387815|Secondary|HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||participants|||Number
2681986|NCT01387815|Secondary|HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||participants|||Number
2681987|NCT01387815|Secondary|HCRU: Number of Complementary/Alternate Therapy Visits at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population||||||
2682101|NCT01387607|Secondary|Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Number of Awakenings After Sleep Onset (sNAASO)|The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Number of Awakenings after Sleep Onset (sNAASO) parameter subjectively estimated the total number of times the participant awakened during the night until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.|||Awakenings||Standard Error|Least Squares Mean
2681988|NCT01387815|Secondary|HCRU: Number of Complementary/Alternate Therapy Visits at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||visits||Standard Deviation|Mean
2681989|NCT01387815|Secondary|HCRU: Number of Complementary/Alternate Therapy Visits at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||visits||Standard Deviation|Mean
2681990|NCT01387815|Secondary|HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||participants|||Number
2681991|NCT01387815|Secondary|HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||participants|||Number
2681992|NCT01387815|Secondary|HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||participants|||Number
2681993|NCT01387815|Secondary|HCRU: Number of Participants Making Use of an Ambulance Service at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||participants|||Number
2682102|NCT01387607|Secondary|Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Latency to Sleep Onset (sLSO)|The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Latency to Sleep Onset (sLSO) parameter subjectively estimated the amount of time to fall asleep after lights out. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.|||Minutes||Standard Error|Least Squares Mean
2681994|NCT01387815|Secondary|HCRU: Number of Participants Making Use of an Ambulance Service at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||participants|||Number
2681995|NCT01387815|Secondary|HCRU: Number of Participants Making Use of an Ambulance Service at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||participants|||Number
2681996|NCT01387815|Secondary|HCRU: Number of Visits to a Hospital Emergency Room at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||visits||Standard Deviation|Mean
2681997|NCT01387815|Secondary|HCRU: Number of Visits to a Hospital Emergency Room at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||visits||Standard Deviation|Mean
2681998|NCT01387815|Secondary|HCRU: Number of Visits to a Hospital Emergency Room at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||visits||Standard Deviation|Mean
2681999|NCT01387815|Secondary|HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||participants|||Number
2682103|NCT01387607|Secondary|Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Wake After Sleep Onset (sWASO)|The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Wake after Sleep Onset (sWASO) parameter subjectively estimated the total amount of time the participant was awake after initial sleep onset until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.|||Minutes||Standard Error|Least Squares Mean
2682000|NCT01387815|Secondary|HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||participants|||Number
2682001|NCT01387815|Secondary|HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||participants|||Number
2682002|NCT01387815|Secondary|HCRU: Number of Visits to A Healthcare Professional at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||office visits||Standard Deviation|Mean
2682003|NCT01387815|Secondary|HCRU: Number of Visits to A Healthcare Professional at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||office visits||Standard Deviation|Mean
2682004|NCT01387815|Secondary|HCRU: Number of Visits to A Healthcare Professional at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||office visits||Standard Deviation|Mean
2682005|NCT01387815|Secondary|HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||participants|||Number
2682104|NCT01387607|Secondary|Change From Baseline in Mean Sleep Interference Score at Week 14|The Daily Sleep Interference Scale was an 11-point numerical scale ranging from 0 (does not interfere with sleep) to 10 (completely interferes [unable to sleep due to pain]). Participants were asked to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily upon awakening. Baseline Mean Sleep Interference score was defined as the mean of all available last 7 sleep interference score diary entries up to and including Day 1.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
2682006|NCT01387815|Secondary|HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||participants|||Number
2682007|NCT01387815|Secondary|HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||participants|||Number
2682008|NCT01387815|Secondary|HCRU: Number of Visits to Another Physician at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||office visits||Standard Deviation|Mean
2682009|NCT01387815|Secondary|HCRU: Number of Visits to Another Physician at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||office visits||Standard Deviation|Mean
2682010|NCT01387815|Secondary|HCRU: Number of Visits to Another Physician at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||office visits||Standard Deviation|Mean
2682011|NCT01387815|Secondary|HCRU: Number of Participants Making Visits to Another Physician at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||participants|||Number
2682105|NCT01387607|Secondary|Percentage of Participants With Optimal Sleep at Week 14 in Medical Outcome Study (MOS)-Sleep Scale|The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Percentage of participants|||Number
2682012|NCT01387815|Secondary|HCRU: Number of Participants Making Visits to Another Physician at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||participants|||Number
2682013|NCT01387815|Secondary|HCRU: Number of Participants Making Visits to Another Physician at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||participants|||Number
2682014|NCT01387815|Secondary|HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||office visits||Standard Deviation|Mean
2682015|NCT01387815|Secondary|HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||office visits||Standard Deviation|Mean
2682016|NCT01387815|Secondary|HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||office visits||Standard Deviation|Mean
2682017|NCT01387815|Secondary|HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||participants|||Number
2682238|NCT01386658|Primary|Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs)|A standard 12-lead ECG was performed after 10 minutes at rest when the participant was seated or supine following treatment. The number of participants who reported clinically significant changes in ECGs were reported.|6 - 8 hours post-dose on Day 1|Safety population consisted of participants who were treated with icatibant at least once during the study.|||Participants|||Count of Participants
2682018|NCT01387815|Secondary|HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||participants|||Number
2682019|NCT01387815|Secondary|HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||participants|||Number
2682020|NCT01387815|Secondary|HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||participants|||Number
2682021|NCT01387815|Secondary|HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||participants|||Number
2682022|NCT01387815|Secondary|HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for Ankylosing Spondylitis (AS) at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||participants|||Number
2682023|NCT01387815|Secondary|HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|"ITT Population of participants who were available for assessment at this visit and answered yes to question of having insurance for prescription medication. Note: One patient may have had more than one medical insurance; therefore, the total of the rows will not match the number analyzed."|||participants|||Number
2682623|NCT01383018|Primary|Number of Participants With Penile Prosthesis Overall Subject Satisfaction|Penile prosthesis overall subject satisfaction (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.|1 year, post-implantation|Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit.|||Participants|||Count of Participants
2682024|NCT01387815|Secondary|HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|"ITT Population of participants who were available for assessment at this visit and answered yes to question of having insurance for prescription medication. Note: One patient may have had more than one medical insurance; therefore, the total of the rows will not match the number analyzed."|||participants|||Number
2682025|NCT01387815|Secondary|HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|"ITT Population of participants who were available for assessment at this visit and answered yes to question of having insurance for prescription medication. Note: One patient may have had more than one medical insurance; therefore, the total of the rows will not match the number analyzed."|||participants|||Number
2682026|NCT01387815|Secondary|HCRU: Number of Participants With Insurance for Prescription Medication at Month 24|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 24|ITT Population|||participants|||Number
2682027|NCT01387815|Secondary|HCRU: Number of Participants With Insurance for Prescription Medication at Month 12|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 12|ITT Population|||participants|||Number
2682028|NCT01387815|Secondary|Healthcare Resource Utilization (HCRU): Number of Participants With Insurance for Prescription Medication at Month 6|Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting ≥1 visit), visits to another doctor (and number of visits among those reporting ≥1 visit), visits to healthcare professional (and number of visits among those reporting ≥1 visit), visits to hospital emergency room (and number of visits among those reporting ≥1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting ≥1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.|Month 6|ITT Population|||participants|||Number
2682029|NCT01387815|Secondary|WLQ Productivity Loss Score: Change From Baseline to Month 24|"The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.~The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation."|Baseline, Month 24|ITT population|||score on a scale||Standard Deviation|Mean
2683293|NCT01377467|Other Pre-specified|Percent Change From Baseline in Cortical Thickness (Ct.Th) at the Distal Radius|Cortical thickness was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mm.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.|||Percent change||95% Confidence Interval|Median
2682030|NCT01387815|Secondary|WLQ Productivity Loss Score: Change From Baseline to Month 12|"The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.~The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation."|Baseline, Month 12|ITT population|||score on a scale||Standard Deviation|Mean
2682031|NCT01387815|Secondary|WLQ Productivity Loss Score: Change From Baseline to Month 6|"The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.~The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation."|Baseline, Month 6|ITT population|||score on a scale||Standard Deviation|Mean
2682032|NCT01387815|Secondary|WLQ Total Score: Change From Baseline to Month 24|"The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.~The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation."|Baseline, Month 24|ITT population|||score on a scale||Standard Deviation|Mean
2682033|NCT01387815|Secondary|WLQ Total Score: Change From Baseline to Month 12|"The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.~The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation."|Baseline, Month 12|ITT population|||score on a scale||Standard Deviation|Mean
2682034|NCT01387815|Secondary|Work Limitation Questionnaire (WLQ) Total Score: Change From Baseline to Month 6|"The Work Limitation Questionnaire (WLQ) is a self-administered questionnaire comprised of 25 questions.~The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work.~The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation."|Baseline, Month 6|ITT population|||score on a scale||Standard Deviation|Mean
2682035|NCT01387815|Secondary|SF-12 PCS Score: Change From Baseline to Month 24|The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 1-4 comprise the physical component of the SF-12. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement.|Baseline, Month 24|ITT population|||score on a scale||Standard Deviation|Mean
2682036|NCT01387815|Secondary|SF-12 PCS Score: Change From Baseline to Month 12|The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 1-4 comprise the physical component of the SF-12. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement.|Baseline, Month 12|ITT population|||score on a scale||Standard Deviation|Mean
2682106|NCT01387607|Secondary|Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Problems Index Overall Score|The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of sleep problem index overall score was 0 to 100, with higher scores indicating more of the attribute.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
2682037|NCT01387815|Secondary|SF-12 Physical Component Summary (PCS) Score: Change From Baseline to Month 6|The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 1-4 comprise the physical component of the SF-12. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement.|Baseline, Month 6|ITT population|||score on a scale||Standard Deviation|Mean
2682038|NCT01387815|Secondary|SF-12 MCS Score: Change From Baseline to Month 24|The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 5-8 comprise the mental component of the SF-12. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement.|Baseline, Month 24|ITT population|||score on a scale||Standard Deviation|Mean
2682039|NCT01387815|Secondary|SF-12 MCS Score: Change From Baseline to Month 12|The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 5-8 comprise the mental component of the SF-12. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement.|Baseline, Month 12|ITT population|||score on a scale||Standard Deviation|Mean
2682040|NCT01387815|Secondary|Medical Outcomes Study Short Form-12 Health Status Survey (SF-12) Mental Component Summary (MCS) Score: Change From Baseline to Month 6|The Medical Outcomes Study Short Form 12 (SF-12) questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 5-8 comprise the mental component of the SF-12. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement.|Baseline, Month 6|ITT population|||score on a scale||Standard Deviation|Mean
2682041|NCT01387815|Secondary|BDI-II: Change From Baseline to Month 24|"The Beck Depression inventory assesses the presence and severity of depression and responsiveness to treatment. It consists of 21 items converging on 2 scales measuring somatic and affective components of depression. The questions assess hopelessness and irritability, cognition such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and loss of interest in sex.~The total score ranges from a minimum of 0 to a maximum of 63 with the following suggested score interpretations: minimal range = 0-13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29-63.~The higher the score, the greater the severity of the depression."|Baseline, Month 24|ITT population|||score on a scale||Standard Deviation|Mean
2682042|NCT01387815|Secondary|BDI-II: Change From Baseline to Month 12|"The Beck Depression inventory assesses the presence and severity of depression and responsiveness to treatment. It consists of 21 items converging on 2 scales measuring somatic and affective components of depression. The questions assess hopelessness and irritability, cognition such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and loss of interest in sex.~The total score ranges from a minimum of 0 to a maximum of 63 with the following suggested score interpretations: minimal range = 0-13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29-63.~The higher the score, the greater the severity of the depression."|Baseline, Month 12|ITT population|||score on a scale||Standard Deviation|Mean
2682043|NCT01387815|Secondary|Beck Depression Inventory II (BDI-II): Change From Baseline to Month 6|"The Beck Depression inventory assesses the presence and severity of depression and responsiveness to treatment. It consists of 21 items converging on 2 scales measuring somatic and affective components of depression. The questions assess hopelessness and irritability, cognition such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and loss of interest in sex.~The total score ranges from a minimum of 0 to a maximum of 63 with the following suggested score interpretations: minimal range = 0-13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29-63.~The higher the score, the greater the severity of the depression."|Baseline, Month 6|ITT population|||score on a scale||Standard Deviation|Mean
2682044|NCT01387815|Secondary|DLQI ≤1: Percentage of Participants at Month 24|The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.|Month 24|ITT population|||percentage of participants|||Number
2683399|NCT01376362|Secondary|Change in Intraocular Pressure (IOP) in the Study Eye at Week One Compared to Baseline|Intraocular pressure was recorded using a standard Goldmann applanation tonometer, a device for the measurement of intraocular pressure between 0 to 78 mm Hg.|Baseline and 1 Week||||mm Hg||Standard Deviation|Mean
2682045|NCT01387815|Secondary|DLQI ≤1: Percentage of Participants at Month 18|The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.|Month 18|ITT population|||percentage of participants|||Number
2682046|NCT01387815|Secondary|DLQI ≤1: Percentage of Participants at Month 12|The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.|Month 12|ITT population|||percentage of participants|||Number
2682047|NCT01387815|Secondary|DLQI ≤1: Percentage of Participants at Month 6|The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.|Month 6|ITT population|||percentage of participants|||Number
2682048|NCT01387815|Secondary|DLQI ≤1: Percentage of Participants at Month 3|The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.|Month 3|ITT population|||percentage of participants|||Number
2682049|NCT01387815|Secondary|Time to Achieving DLQI ≤1|The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.|Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24|ITT population|||Months||95% Confidence Interval|Median
2682050|NCT01387815|Secondary|DLQI Total Score: Change From Baseline to Month 24|The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.|Baseline, Month 24|ITT population|||score on a scale||Standard Deviation|Mean
2682051|NCT01387815|Secondary|DLQI Total Score: Change From Baseline to Month 18|The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.|Baseline, Month 18|ITT population|||score on a scale||Standard Deviation|Mean
2682115|NCT01387594|Secondary|Cohorts 1 and 2: Number of Participants With Injection Site Reactions by Severity|Injection site reaction AEs include: injection site irritation, injection site pain, injection site rash, contusion, and erythema.|Baseline till End of Study/Early Withdrawal, up to Week 12|All participants who received at least one dose of study drug.|||participants|||Number
2684381|NCT01368497|Secondary|Proportion of Participants With HBV DNA ≤1000 IU/mL||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
2682052|NCT01387815|Secondary|DLQI Total Score: Change From Baseline to Month 12|The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.|Baseline, Month 12|ITT population|||score on a scale||Standard Deviation|Mean
2682053|NCT01387815|Secondary|DLQI Total Score: Change From Baseline to Month 6|The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.|Baseline, Month 6|ITT population|||score on a scale||Standard Deviation|Mean
2682054|NCT01387815|Secondary|Dermatology Quality of Life Index (DLQI) Total Score: Change From Baseline to Month 3|The Dermatology Quality of Life Index (DLQI) is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.|Baseline, Month 3|ITT population|||score on a scale||Standard Deviation|Mean
2682055|NCT01387815|Secondary|PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 24|PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.|Baseline, Month 24|ITT population|||units on a scale||Standard Deviation|Mean
2682056|NCT01387815|Secondary|PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 18|PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.|Baseline, Month 18|ITT population|||units on a scale||Standard Deviation|Mean
2682057|NCT01387815|Secondary|PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 12|PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.|Baseline, Month 12|ITT population|||units on a scale||Standard Deviation|Mean
2682058|NCT01387815|Secondary|PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 6|PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.|Baseline, Month 6|ITT population|||units on a scale||Standard Deviation|Mean
2682059|NCT01387815|Secondary|Patient Global Assessment (PtGA) of Disease Activity Based on a Visual Analog Scale (VAS): Change From Baseline to Month 3|Patient Global Assessment of disease activity (PtGA) was assessed using a visual analog scale (VAS) where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.|Baseline, Month 3|ITT population|||units on a scale||Standard Deviation|Mean
2682060|NCT01387815|Secondary|BSA of Psoriasis Involvement: Change From Baseline to Month 24|The BSA is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.|Baseline, Month 24|ITT population of participants who were available for assessment at this visit.|||percentage estimated body surface area||Standard Deviation|Mean
2682061|NCT01387815|Secondary|BSA of Psoriasis Involvement: Change From Baseline to Month 18|The BSA is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.|Baseline, Month 18|ITT population of participants who were available for assessment at this visit.|||percentage estimated body surface area||Standard Deviation|Mean
2682062|NCT01387815|Secondary|BSA of Psoriasis Involvement: Change From Baseline to Month 12|The BSA is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.|Baseline, Month 12|ITT population of participants who were available for assessment at this visit.|||percentage estimated body surface area||Standard Deviation|Mean
2682063|NCT01387815|Secondary|Body Surface Area of Psoriasis Involvement: Change From Baseline to Month 6|The Body Surface Area (BSA) is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.|Baseline, Month 6|ITT population of participants who were available for assessment at this visit.|||percentage estimated body surface area||Standard Deviation|Mean
2682064|NCT01387815|Secondary|PASQ Total Score: Change From Baseline to Month 24|PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.|Baseline, Month 24|ITT population of participants who were available for assessment at this visit.|||score on a scale||Standard Deviation|Mean
2682065|NCT01387815|Secondary|PASQ Total Score: Change From Baseline to Month 18|PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.|Baseline, Month 18|ITT population of participants who were available for assessment at this visit.|||score on a scale||Standard Deviation|Mean
2682066|NCT01387815|Secondary|PASQ Total Score: Change From Baseline to Month 12|PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.|Baseline, Month 12|ITT population of participants who were available for assessment at this visit.|||score on a scale||Standard Deviation|Mean
2682067|NCT01387815|Secondary|PASQ Total Score: Change From Baseline to Month 6|PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.|Baseline, Month 6|ITT population of participants who were available for assessment at this visit.|||score on a scale||Standard Deviation|Mean
2682068|NCT01387815|Secondary|Psoriasis and Arthritis Screening Questionnaire (PASQ) Total Score: Change From Baseline to Month 3|PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.|Baseline, Month 3|ITT population of participants who were available for assessment at this visit.|||score on a scale||Standard Deviation|Mean
2682069|NCT01387815|Secondary|PGA≤1: Percentage of Participants at Month 24|"The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:~0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;~1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;~2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;~3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;~4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;~5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.~A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit."|Month 24|ITT population|||percentage of participants|||Number
2682070|NCT01387815|Secondary|PGA≤1: Percentage of Participants at Month 18|"The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:~0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;~1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;~2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;~3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;~4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;~5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.~A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit."|Month 18|ITT population|||percentage of participants|||Number
2682116|NCT01387594|Secondary|Cohorts 1 and 2: Number of Participants Who Developed Anti-Drug Antibodies (ADAs) to PF-00547659|Serum samples were analysed for presence of ADAs to PF-00547659. Participants who showed positive results for PF-00547659 were reported.|Day 1; Weeks 4, 8, 9-11 (Cohort 2 only), 12, 20, 28, and 36; Early Withdrawal|All participants who received at least one dose of study drug.|||participants|||Number
2693595|NCT01294163|Secondary|Depth of Anaesthesia|On-line monitoring of depth of anaesthesia from bi-spectral electroencephalogram analysis (BIS monitor)|4 hours|||||||
2682071|NCT01387815|Secondary|PGA≤1: Percentage of Participants at Month 12|"The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:~0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;~1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;~2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;~3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;~4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;~5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.~A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit."|Month 12|ITT population|||percentage of participants|||Number
2682072|NCT01387815|Secondary|PGA≤1: Percentage of Participants at Month 3|"The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:~0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;~1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;~2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;~3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;~4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;~5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.~A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit."|Month 3|ITT population|||percentage of participants|||Number
2682073|NCT01387815|Secondary|Time to Achieving PGA ≤ 1|"The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:~0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;~1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;~2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;~3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;~4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;~5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.~A higher score indicates greater disease severity."|Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24|ITT population|||Months||95% Confidence Interval|Median
2682074|NCT01387815|Primary|Percentage of Participants With a Physician Global Assessment (PGA) Score ≤1 at Month 6|"The Physician global assessment (PGA) score is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories:~0 (Clear): No evidence of scaling or plaque elevation; erythema may be present;~1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation;~2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation;~3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation;~4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation;~5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation.~A higher score indicates greater disease severity. Percentages based on the total number of intent to treat (ITT) participants who attended each visit."|Month 6|ITT population: all participants who signed informed consent, met inclusion/exclusion criteria, and received at least 1 dose of study medication.|||percentage of participants|||Number
2682075|NCT01387789|Secondary|Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 3 Months|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst-100 best). The standard recall period is four weeks. Increases from baseline indicate improvement. Assessments were conducted at baseline and 3 months."|Baseline and 3 months||||units on a scale||Standard Deviation|Mean
2682076|NCT01387789|Secondary|Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 3 Months|The Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) is a patient-reported questionnaire designed to assess the presence or absence of arthritis-related pain and its severity. It consists of a doubly anchored, horizontal VAS, that is scored from 0 (no pain) to 100 (severe pain). Decreases from baseline indicate improvement. Assessments were conducted at baseline and 3 months.|Baseline and 3 months|Participants with available data at this time point|||centimeters||Standard Deviation|Mean
2682077|NCT01387789|Secondary|Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 3 Months|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 3 months.|Baseline and 3 months||||units on a scale||Standard Deviation|Mean
2682127|NCT01387516|Primary|American Thoracic Society Questionnaire (ATSQ)|This validated 8 item measure assesses the frequency of experiencing several respiratory symptoms using a 5 point Likert scale from 1, never to 5, every day. The minimum score is 8 indicating no experience of respiratory symptoms and the maximum score is 40 which indicates a high frequency of experiencing respiratory symptoms.|6 months post release|Participants who received individual (MI or RT) and group treatment (CBT or SHP) and who also received a 6 month follow up.|||score on a scale||Standard Deviation|Mean
2682078|NCT01387789|Secondary|Change in Mean Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 1 Month|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst-100 best). The standard recall period is four weeks. Increases from baseline indicate improvement. Assessments were conducted at baseline and 1 month."|Baseline and 1 month||||units on a scale||Standard Deviation|Mean
2682079|NCT01387789|Secondary|Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 1 Month|The Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) is a patient-reported questionnaire designed to assess the presence or absence of arthritis-related pain and its severity. It consists of a doubly anchored, horizontal VAS, that is scored from 0 (no pain) to 100 (severe pain). Decreases from baseline indicate improvement. Assessments were conducted at baseline and 1 month.|Baseline and 1 month|Participants with available data at this time point|||centimeters||Standard Deviation|Mean
2682080|NCT01387789|Secondary|Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 1 Month|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 1 month.|Baseline and 1 month||||units on a scale||Standard Deviation|Mean
2682081|NCT01387789|Primary|Change in Health Assessment Questionnaire Short Form 36 (SF-36) Scores From Baseline to 6 Months|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst-100 best). The standard recall period is four weeks. Increases from baseline indicate improvement. Assessments were conducted at baseline and 6 months."|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
2682082|NCT01387789|Primary|Change in Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) Scores From Baseline to 6 Months|The Health Assessment Questionnaire Visual Analog Scale (HAQ-VAS) is a patient-reported questionnaire designed to assess the presence or absence of arthritis-related pain and its severity. It consists of a doubly anchored, horizontal VAS, that is scored from 0 (no pain) to 100 (severe pain). Decreases from baseline indicate improvement. Assessments were conducted at baseline and 6 months.|Baseline and 6 months||||centimeters||Standard Deviation|Mean
2682083|NCT01387789|Primary|Change in Overall Health Assessment Questionnaire Disability Index (HAQ-DI) Scores From Baseline to 6 Months|The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥ 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from baseline in the overall score indicate improvement. Assessments were conducted at baseline and 6 months.|Baseline and 6 months||||units on a scale||Standard Deviation|Mean
2682084|NCT01387737|Secondary|Change in Blood Pressure||Week 52|||||||
2682085|NCT01387737|Secondary|Change in Body Weight||Week 52|||||||
2682086|NCT01387737|Secondary|Change in Fasting Plasma Glucose||Week 52|||||||
2682087|NCT01387737|Secondary|Change in HbA1c||Week 52|||||||
2682088|NCT01387737|Primary|Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events||54 weeks||||percentage of incidences|||Number
2682089|NCT01387672|Secondary|Headache|"Severity of headaches. Subjects recorded the severity of headaches upon awakening every day during the run-in phase using a visual analogue scale (VAS). The scale is represented by a line (continuum) 10 cm long. Subjects were asked to make a vertical line along the continuum to indicate the severity of their headache each morning upon awakening. The score is recorded in cm from 0 to 10. A vertical line marked at 0 means no headache (score recorded = 0), a vertical line marked at 10 means a terrible headache (score recorded = 10)."|Run-in phase - 2 days|The mean headache score considering all subjects in each of the treatment/formulation group was calculated.|||score on a scale||Standard Deviation|Mean
2682090|NCT01387672|Primary|Bone Turnover Markers|"Markers of Bone Formation:~Serum Procollagen type 1 amino- terminal propeptide (P1NP)~Serum Osteocalcin (OC)~Serum Bone-specific alkaline phosphatase (BALP)~Markers of Bone Resorption:~- Serum C-telopeptides of collagen cross-links (CTX)"|3 months|One subject from the Treatment Arm 3 had outlier bone turnover markers values and was excluded from the analysis. Total number of subjects analyzed in Treatment Arm 3 was therefore 32.|||Percent change from baseline||Standard Deviation|Mean
2693859|NCT01290822|Secondary|Peak LV dP/dt||13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.||||||
2682092|NCT01387607|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs|An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device. A Serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect. Treatment-emergent AEs (TEAEs) were events between first dose of study drug and up to follow-up visit (Study Day 105) that were absent before treatment or that worsened after treatment. AEs included both SAEs and non-SAEs.|Baseline to Follow up (Day 105)|The Safety Analysis Set was defined as all randomized participants who received at least 1 dose of study medication.|||Participants|||Number
2682093|NCT01387607|Secondary|Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score|The Hospital Anxiety and Depression Scale (HADS) was a self-reported 14-item instrument that consisted of two 7-item subscales that measure the presence and severity of anxiety and depression. For each subscale, range was 0 to 21, with higher scores indicating greater impairment.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
2682094|NCT01387607|Secondary|Change From Baseline at Week 14 in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score|The Hospital Anxiety and Depression Scale (HADS) was a self-reported 14-item instrument that consisted of two 7-item subscales that measure the presence and severity of anxiety and depression. For each subscale, score range was 0 to 21, with higher scores indicating greater impairment.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
2682095|NCT01387607|Secondary|Change From Baseline in Pain Visual Analog Scale (Pain VAS) Score at Week 14|"The Pain Visual Analog Scale (Pain VAS) was a horizontal line; 100 mm in length, self administered by the participants in order to rate pain from 0 no pain to 100 worst possible pain."|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
2682096|NCT01387607|Secondary|Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Physical Component Summary Score|The Short-Form 36 Health Survey (SF-36) was a self-administered questionnaire that measured each of the following 8 health concepts: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. Physical component included physical functioning, role limitations due to physical problems, social functioning and bodily pain. Score range for physical component summary score was 0 to 100 and higher scores reflected better participant status.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
2682097|NCT01387607|Secondary|Change From Baseline at Week 14 in Short-Form 36 (SF-36) Health Survey - Mental Component Summary Score|The Short-Form 36 Health Survey (SF-36) was a self-administered questionnaire that measured each of the following 8 health concepts: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. Mental component included mental health, role limitations due to emotional problems, vitality and general health perception. Score range for mental component summary score was 0 to 100 and higher scores reflected better participant status.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
2682098|NCT01387607|Secondary|Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Score at Week 14|The Multidimensional Assessment of Fatigue (MAF) scale was a self-administered survey that yielded a Global Fatigue Index by assessing the participant's level of fatigue and the degree to which fatigue interferes with activities of daily living. It contained 16 items and measured 4 dimensions of fatigue: severity (2 items), distress (1 item), degree of interference in activities of daily living (11 items), and timing (2 items). Index range was 1 to 50 and higher scores reflected greater impairment.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
2682099|NCT01387607|Secondary|Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Sleep Quality|The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Sleep Quality parameter subjectively rated the quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
2682100|NCT01387607|Secondary|Change From Baseline at Week 14 in Subjective Sleep Questionnaire (SSQ) - Subjective Total Sleep Time (sTST)|The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Total Sleep Time (sTST) parameter subjectively estimated the total amount of time the participant was asleep after lights out until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.|||Minutes||Standard Error|Least Squares Mean
2684382|NCT01368497|Secondary|Proportion of Participants With ALT ≤ 40 U/L for Males, ≤ 35 U/L for Females||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
2682107|NCT01387607|Secondary|Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Quantity of Sleep and Somnolence Subscale Scores|The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of quantity of sleep parameter was 0 to 24 and somnolence was 0 to 100, with higher scores indicating more of the attribute.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
2682108|NCT01387607|Secondary|Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Snoring, Awaken Short of Breath and Sleep Adequacy Subscale Scores|The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of scores represented for snoring, awaken short of breath and sleep adequacy was 0 to 100, with higher scores indicating more of the attribute.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
2682109|NCT01387607|Secondary|Change From Baseline at Week 14 in Medical Outcome Study (MOS)-Sleep Scale - Sleep Disturbance Subscale Score|The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of scores represented for sleep disturbance was 0 to 100, with higher scores indicating more of the attribute.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
2682110|NCT01387607|Secondary|Percentage of Participants With at Least 50% Reduction in Weekly Mean Pain Score From Baseline to Week 14|Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 50% reduction in weekly mean pain score from baseline to Week 14 was defined as a 50% responder.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Percentage of participants|||Number
2682111|NCT01387607|Secondary|Percentage of Participants With at Least 30% Reduction in Weekly Mean Pain Score From Baseline to Week 14|Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 30% reduction in weekly mean pain score from baseline to Week 14 was defined as a 30% responder.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Percentage of participants|||Number
2682112|NCT01387607|Secondary|Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score at Week 14|The Fibromyalgia Impact Questionnaire (FIQ) was a 20-item participant-reported outcome instrument designed to assess health status, progress, and outcomes in participants with fibromyalgia. It contained 10 subscales. There were 11 questions that are related specifically to physical functioning. The remaining items assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. Score range for each subscale was 0 to 10. The 10 subscales were combined to yield a total score with range from 0 to 100. The total score provided an estimation of fibromyalgia impact with higher scores indicating greater impairment.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used.|||Units on a scale||Standard Error|Least Squares Mean
2682113|NCT01387607|Secondary|Percentage of Participants Categorized by Each Patient Global Impression of Change (PGIC) Score at Week 14|The Patient Global Impression of Change (PGIC) was a participant-rated instrument that measured change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse), which was based on a validated scale, the Clinical Global Impression of Change (CGIC). Categories were defined based on the PGIC scores as followed: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse.|Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.|||Percentage of participants|||Number
2682114|NCT01387607|Primary|Change From Baseline in Endpoint Mean Pain Score During the Double-blind Treatment Period at Week 14|Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. The endpoint mean pain score was defined as the mean of the Week 14 pain diary entries in the double-blind treatment phase. Baseline was defined as the mean of last 7 pain diary entries up to and including Day 1.|Baseline, Week 14|The Full Analysis Set (FAS) was defined as all randomized participants who received at least 1 dose of study medication.|||Units on a scale||Standard Error|Least Squares Mean
2683578|NCT01374906|Secondary|Percentage of Patients Who Attain mUFC ≤ 1.0 x ULN|Controlled responder: mUFC ≤ 1.0×ULN by randomized groups.|M7, M12, M24, M36|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2682117|NCT01387594|Secondary|Cohorts 1 and 2: Total Number of Participants With Non-Lumbar Puncture (LP) Related Treatment-Emergent Adverse Events (AEs), Withdrawals Due to AEs, and Serious Adverse Events (SAEs) During the 12-week Treatment Period|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent for this measure are events between first dose of study drug and up to 85 days (Week 12) after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included serious and non-serious AEs.|Baseline up to Week 12|All participants who received at least one dose of study drug were analyzed for AEs/safety. Combined data for both cohorts is presented.|||participants|||Number
2682118|NCT01387594|Primary|Cohort 2: Percent Change From Baseline in Absolute Lymphocyte Count in CSF at Month 3|The primary CSF endpoint of Cohort 2 was the percent change from baseline in absolute lymphocyte counts in CSF after 3 doses of PF-00547659. The hypothesis for the primary endpoint was evaluated using the CSF evaluable population in Cohort 2. CSF samples were obtained via lumbar puncture and analyzed by FACS for total lymphocyte counts. Lumbar punctures were performed by a highly qualified physician using a 20-22 gauge needle, preferably an atraumatic needle.|Baseline, Month 3|All Cohort 2 participants who were enrolled, had 2 evaluable lumbar punctures, and who received all 3 doses of study drug.|||percent change||Full Range|Median
2682119|NCT01387594|Primary|Cohort 2: Baseline Absolute Lymphocyte Count in Cerebrospinal Fluid (CSF)|The primary CSF endpoint of Cohort 2 was the percent change from baseline in absolute lymphocyte counts in CSF after 3 doses of PF-00547659. The hypothesis for the primary endpoint was evaluated using the CSF evaluable population in Cohort 2. CSF samples were obtained via lumbar puncture and analyzed by fluorescence-activated cell sorting (FACS) for total lymphocyte counts. Lumbar punctures were performed by a highly qualified physician using a 20-22 gauge needle, preferably an atraumatic needle.|Baseline|All Cohort 2 participants who were enrolled, had 2 evaluable LPs, and who received all 3 doses of study drug.|||cells per milliliter (cells/mL)||Full Range|Median
2682120|NCT01387581|Primary|Specificity|"Dermatologist specificity is the percent of non-melanomas that dermatologists selected not to biopsy. MelaFind specificity is the percent of non-melanomas that MelaFind called Negative."|Within 120 days of Data Lock||||percent of true negatives||95% Confidence Interval|Mean
2682121|NCT01387581|Primary|Sensitivity|"Dermatologist sensitivity is the percent of melanomas that dermatologists selected to biopsy. MelaFind sensitivity is the percent of melanomas that MelaFind called Positive."|Within 120 days of Data Lock||||percent of true positives||95% Confidence Interval|Mean
2682122|NCT01387542|Primary|Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 10|The PSP scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 10|Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
2682123|NCT01387542|Primary|Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 6|The PSP scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 6|Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
2682124|NCT01387542|Primary|Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 2|The PSP scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.|Baseline, Week 2|Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
2682125|NCT01387542|Primary|Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale at Week 10|"The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening ."|Baseline, Week 10|Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation.|||Units on a scale||Standard Deviation|Mean
2682126|NCT01387516|Primary|Percent Smoking Days|Using a Time-Line Follow-back, we calculated percent smoking days for a 60 day period at 6-month follow-up. This is the percentage of smoking days a participant had out of possible smoking days (days for which the participant was not in a controlled environment where they did not have access to cigarettes).|6 months post release|Includes participants who received individual (MI or RT) and group (CBT or SHP) treatment who also had a 6 month follow up and access to cigarettes. Participants who spent all 90 days of this assessment period in a controlled environment where they did not have access to cigarettes were excluded from this analysis.|||percentage of smoking days||Standard Deviation|Mean
2684383|NCT01368497|Secondary|Proportion of Participants With Alanine Aminotransferase (ALT) ≤ 40 Units (U) Per Liter (L) for Males, ≤ 35 U/L for Females||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
2682132|NCT01387347|Primary|Ocular Discomfort in the Worst Eye in the Controlled Adverse Environment(CAE) Model, Which is a Regulated Environmental Setting Aimed at Exacerbating the Signs and Symptoms of Dry Eye.|"Dry eye causes ocular discomfort, which is measured using a validated 4-point ORA Scale from the start of the dosing till the end of treatment (Day 29). 0 = no discomfort to 4 = constant discomfort.~If the measurement is lower, then improvement of ocular discomfort can be inferred. The test is carried out throughout the study till end of treatment Day 29. However, the primary outcome measure itself is determined on Day 29.~Worst eye: In the case that both eyes were eligible for analysis, the worst eye was chosen as the eye with the greater increase of inferior corneal staining from Visit 1 to Visit 2. If both eyes were equal, the eye with greater ocular discomfort at Visit 2 was chosen as the worst eye. If both eyes had were equal at Visit 2, then the right eye was chosen as the worst eye."|Day 29 (end of treatment)|Intent to Treat (ITT)|||Units on a Scale||Standard Deviation|Mean
2682133|NCT01387347|Primary|Corneal Staining (Inferior Region) in the Worst Eye in the Controlled Adverse Environment (CAE) Model, Which is a Regulated Environmental Setting Aimed at Exacerbating the Signs and Symptoms of Dry Eye|"This is a test that uses orange dye (fluorescein) and a blue light to detect ocular surface defects associated with dry eye. If the test result is normal, the dye remains in the tear film on the surface of the eye and does not adhere to the eye itself. The test is carried out throughout the study till end of treatment Day 29. However, the primary outcome measure itself is determined on Day 29. The scale used to determine the difference in corneal fluorescein staining between RGN-259 and placebo is the ORA scale: 0= no staining (no detectable ocular defect)to 4= confluent staining( severe ocular defect).~Worst eye: In the case that both eyes were eligible for analysis, the worst eye was chosen as the eye with the greater increase of inferior corneal staining from Visit 1 to Visit 2. If both eyes were equal, the eye with greater ocular discomfort at Visit 2 was chosen as the worst eye. If both eyes were equal at Visit 2, then the right eye was chosen as the worst eye."|Day 29 (end of treatment)|Intent to Treat population|||units on a scale||Standard Deviation|Mean
2682134|NCT01387282|Secondary|Change in Body Weight|Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.|Change in Body Weight from Baseline Over 12 Weeks|Modified Intent-to-Treat Population|||kg||Standard Error|Least Squares Mean
2682135|NCT01387282|Secondary|Change in FACIT-F Fatigue Domain Score|"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue domain is a 13-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).~The 13-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the FACIT-F fatigue domain ranges from 0 (worst) to 52 (best)."|Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks|Modified Intent-to-Treat Population|||scores on a scale||Standard Error|Least Squares Mean
2682136|NCT01387282|Secondary|Change in A/CS Domain Score|"The Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Additional Concerns Subscale (A/CS domain) is a 12-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).~The 12-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the A/CS domain ranges from 0 (worst) to 48 (best)."|Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks|Modified Intent-to-Treat Population|||scores on a scale||Standard Error|Least Squares Mean
2682137|NCT01387282|Primary|Change in Handgrip Strength|Change in Handgrip Strength (HGS) of the non-dominant hand from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.|Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks|Intent-to-Treat Population. Some patients in the ITT population were excluded from the primary LBM/HGS analysis (i.e., multiple imputations/ranking method) if they survived to Week 12 but missed their baseline covariates including LBM, HGS, or ECOG OR had Week 6 and Week 12 outcomes that were outside the visit windows.|||kg||95% Confidence Interval|Median
2682138|NCT01387282|Primary|Change in Lean Body Mass|Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.|Change in Lean Body Mass from Baseline Over 12 Weeks|Intent-to-Treat Population. Some patients in the ITT population were excluded from the primary LBM/HGS analysis (i.e., multiple imputations/ranking method) if they survived to Week 12 but missed their baseline covariates including LBM, HGS, or ECOG OR had Week 6 and Week 12 outcomes that were outside the visit windows.|||kg||95% Confidence Interval|Median
2682139|NCT01387269|Secondary|Change in Body Weight|Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.|Change in Body Weight from Baseline Over 12 Weeks|Modified Intent-to-Treat Population|||kg||Standard Error|Least Squares Mean
2682140|NCT01387269|Secondary|Change in FACIT-F Fatigue Domain Score|"The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue domain is a 13-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).~The 13-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the FACIT-F fatigue domain ranges from 0 (worst) to 52 (best)."|Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks|Modified Intent-to-Treat Population|||scores on a scale||Standard Error|Least Squares Mean
2682141|NCT01387269|Secondary|Change in A/CS Domain Score|"The Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Additional Concerns Subscale (A/CS domain) is a 12-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).~The 12-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the A/CS domain ranges from 0 (worst) to 48 (best)."|Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks|Modified Intent-to-Treat Population|||scores on a scale||Standard Error|Least Squares Mean
2682144|NCT01387230|Secondary|Change From Baseline in Serial FEV1 Over 24 Hours Post-dose at Days 1 and 84 (Week 12)|Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. Serial FEV1 measurements were taken electronically by spirometry. Serial FEV1 measurements of interest for Day 1 were collected at 1, 3, 6, 23 and 24 hours post-dose on Day 1 and for Day 84, the measures were pre-dose (24 hours post-dose of Day 83 morning dose but prior to Day 84's dose) and 1, 3, 6, 23 and 24 hours post dose on Day 84. Baseline is the mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1. Change from Baseline was calculated as FEV1 value at the evaluated time point minus Baseline. Analysis performed separately by Visit/Day using a repeated measures model with covariates of treatment, Baseline, smoking status, center group, time, time by Baseline and time by treatment interactions.|Baseline, Day 1 and Day 84|ITT Population. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different participants may have been analyzed at different time points (represented by n=X, X, X in the category titles), so the overall number of participants analyzed reflects everyone in the ITT Population.|||Liters||Standard Error|Least Squares Mean
2682145|NCT01387230|Secondary|Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Days 1, 28 (Week 4) and 84 (Week 12)|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 28, and Day 84 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 1 hour, 3 hours, and 6 hours. Change from Baseline was the WM minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Days 1, 28 and 84|ITT Population. All participants with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different participants may have been analyzed at different time points (represented by n=X, X, X in the category titles), so the overall number of participants analyzed reflects everyone in the ITT Population.|||Liters||Standard Error|Least Squares Mean
2682146|NCT01387230|Primary|Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 14, 28, 56, 84, and 85. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 85 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 84). Change from Baseline was calculated as the trough FEV1 minus the Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions.|Baseline and Day 85|Intent-to-Treat (ITT) Population: all randomized par. who received >=1 dose of study drug. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with >=1 post-BL measurement were included in the analysis.|||Liters||Standard Error|Least Squares Mean
2682147|NCT01387178|Secondary|Number of COPD-related Healthcare Encounters||1 year|A subpopulation of participants with an index date between January 1, 2004 and September 30, 2007|||number of encounters|||Number
2682148|NCT01387178|Primary|Mean Number of COPD Exacerbations|Moderate COPD exacerbations were defined as the occurrence of a COPD-related emergency department (ED) visit or a COPD-related office visit that is closely followed by a prescription claim for oral steroids or antibiotics. Severe exacerbations were defined as the occurrence of a COPD-related hospital admission.|1 year|The total population including participants with index dates between January 1,2004 and June 30, 2008.|||number of exacerbations||Standard Deviation|Mean
2682149|NCT01387178|Primary|Post-index Period COPD-related, Unadjusted Costs|The mean cost per participant for COPD-related healthcare interventions for one year following the index date (first pharmacy claim for fluticasone propionate/salmeterol 250 µg/50 µg [FSC] or tiotropium bromide [TIO]) was calculated. Total medical costs included inpatient, emergency department, and outpatient costs associated with the treatment of COPD. Total pharmacy costs included costs of all COPD-related medications, and total healthcare costs included all medical and pharmacy costs that were related to COPD treatment. These costs were unadjusted and reflect the actual costs.|1 year|A subpopulation of participants with an index date between January 1, 2004 and September 30, 2007|||United States (US) dollars||Standard Deviation|Mean
2682150|NCT01387139|Secondary|Nurse Satisfaction|Measured on a 10-point scale (1= least satisfied, 10= most satisfied)|After procedure is completed, on average less than 1 hour||||units on a scale||Inter-Quartile Range|Median
2682151|NCT01387139|Secondary|Physician Performing Procedure Satisfaction|Measured on a 10-point scale (1= least satisfied, 10= most satisfied)|After procedure is completed, on average less than 1 hour||||units on a scale||Inter-Quartile Range|Median
2682152|NCT01387139|Secondary|Parent Satisfaction|Measured on a 10-point scale (1= least satisfied, 10= most satisfied)|After procedure is completed, on average less than 1 hour||||units on a scale (1-10)||Inter-Quartile Range|Median
2682153|NCT01387139|Secondary|Efficacy of Sedation|"Efficacy is defined as:~The patient does not have unpleasant recall of the procedure.~The patient did not experience sedation-related adverse events resulting in abandonment of the procedure or a permanent complication or an unplanned admission to the hospital or prolonged emergency department (ED) observation~The patient did not actively resist or require physical restraint for completion of the procedure. The need for minimal redirection of movements should not be considered as active resistance or physical restraint.~The procedure was successful"|After procedure is completed, on average less than 1 hour||||participants|||Number
2682154|NCT01387139|Secondary|Recovery Time|Time until the patient has a Vancouver Sedation Recovery Scale Score of 18 or greater.|Once Vancouver Sedation Recovery Scale Score reaches 18 or greater, on average less than 1 hour||||minutes||Inter-Quartile Range|Median
2684384|NCT01368497|Secondary|Proportion of Participants With HBsAg Seroconversion||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
2682156|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Week 24|The MAS assessed the degree of muscle tone during movement of the thumb compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Week 24|Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.|||Participants|||Number
2682157|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Thumb at Baseline|The MAS assessed the degree of muscle tone during movement of the thumb compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Baseline|Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.|||Participants|||Number
2682158|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Week 24|The MAS assessed the degree of muscle tone during movement of the fingers compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Week 24|Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.|||Participants|||Number
2682159|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Fingers at Baseline|The MAS assessed the degree of muscle tone during movement of the fingers compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Baseline|Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.|||Participants|||Number
2682160|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Week 24|The MAS assessed the degree of muscle tone during movement of the wrist compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Week 24|Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.|||Participants|||Number
2682161|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Wrist at Baseline|The MAS assessed the degree of muscle tone during movement of the wrist compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Baseline|Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.|||Participants|||Number
2682175|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 7|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:~= Normal, not ill at all~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill subjects~A negative change from Baseline to Visit 7 indicates an improvement in CGI Item 1."|From Baseline up to 13 months|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.|||score on a scale||Standard Deviation|Mean
2682162|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Week 24|The MAS assessed the degree of muscle tone during movement of the elbow compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Week 24|Participants from the Efficacy population (all participants who received BOTOX® not previously treated with botulinum toxin) who had data available for this outcome measure.|||Participants|||Number
2682163|NCT01387074|Primary|Muscle Tone as Measured by the Modified Ashworth Scale (MAS) in the Elbow at Baseline|The MAS assessed the degree of muscle tone during movement of the elbow compared to normal muscle tone using a 6-point scale where: 0=no increase in muscle tone, 1=Slight increase in muscle tone manifested by a catch and release or by minimal resistance at the end of the range of motion when the part is moved, 1+=Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the range of motion, 2=Marked increase in muscle tone through most of the range of motion but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part rigid in movement or extension. A low score indicated little or no stiffness (best). A high score indicated severe stiffness (worse). The number of participants in each score category is presented.|Baseline|Efficacy population included all participants who received BOTOX® not previously treated with botulinum toxin.|||Participants|||Number
2682164|NCT01387022|Secondary|Genital Viral Shedding (Viral Load on Tear Flow)||3 years|Data were not collected for this Outcome Measure||||||
2682165|NCT01387022|Secondary|Cellular and Humoral Immune Responses|We will assess whether exposure to tenofovir gel at the time of HIV acquisition alters the subsequent humoral and cellular immune responses following antiretroviral treatment initiation|3 years|Data were not collected for this Outcome Measure||||||
2682166|NCT01387022|Secondary|Reported Adverse Events With Severity Grades 3 and 4 Based on the DAIDS Toxicity Grading Tables||From randomisation until either time of termination or time of death|All participants who randomised and initiated on ART|||Participants|||Count of Participants
2682167|NCT01387022|Secondary|Tenofovir Resistance, Defined as Presence of K65R, K70E or Any of the TAMS Mutations||From randomisation until either time of termination or time of death|Resistance testing was only done on participants who were failing first line antiretroviral therapy.|||Participants|||Count of Participants
2682168|NCT01387022|Secondary|Change in CD4+ Cell Count From Randomisation to 12 Months Post-randomisation|Difference between 12 months and randomisation CD4+ count was calculated and then summarised|Measured at 12 months post ART initiation|All participants for whom CD4+ count measurements were recorded at randomisation and at 12 months|||cells/uL||Inter-Quartile Range|Median
2682169|NCT01387022|Primary|The Antiretroviral Treatment Failure Rate at 12 Months.|Treatment failure is defined as viral load > 50 copies/ml, antiretroviral regimen changes for treatment failure or death|12 months post ART intiation or until time of death|All participants who randomised and initiated on ART|||participants|||Number
2682170|NCT01386983|Secondary|Dollar Amount of Enlarged Prostate (EP)-Related Medical Costs Incurred Per Month|EP-related charges were defined as medical claims submitted to The Health Alliance Plan (HAP), a Health Maintenance Organization (HMO) owned and operated by the Henry Ford Heath System (HFHS) for reimbursement and internal billing data that had a primary diagnosis of EP. Charges were assessed during months 5 to 12 of the variable follow-up period. Follow-up could end only due to end of continuous eligibility, end of study period, or end of 1-year follow-up. Charges were computed on a per-month basis due to differences in the length of follow-up in the sample.|3 months prior to and 12 months following index date|Enrolled Population|||dollars||95% Confidence Interval|Mean
2682171|NCT01386983|Primary|Number of Participants With Clinical Progression|Participants with clinical progression are defined as those with acute urinary retention and/or receiving prostate-related surgery.|3 months prior to and 12 months following index date|Participants with enlarged prostate during the enrollment period (EP)/pre-index period; treated with AB and 5ARI within 180 days of index date (ID), or 5ARI only, in the EP; and with continuous Health Maintenance Organization enrollment (access to medical/pharmacy services) for at least 3 months prior to and 5 months of ID.|||participants|||Number
2682172|NCT01386970|Primary|3TC-TP Drug Levels Compared Between HIV Negative and HIV Infected Subject|To compare 3TC- triphosphate concentrations in HIV-negative versus HIV-infected subjects.|Day 12 of dosing||||pmol/10^6 cells||Inter-Quartile Range|Median
2682173|NCT01386970|Primary|ZDV-TP Drug Levels Compared Between HIV Negative and HIV Infected Subject|To compare ZDV- triphosphate concentrations in HIV-negative versus HIV-infected subjects.|Day 12 of dosing||||pmol/10^6 cells||Inter-Quartile Range|Median
2682174|NCT01386944|Secondary|Change in Treatment Regimen Used for Switching to Neupro® up to 28 Days After Entering in the Study|Case reports from clinical practice refer to different switching regimens for patients taking oral dopaminergics who experienced augmentation and then switched to Neupro®. The previous dopaminergic treatment might have been partly or completely down-titrated prior to switching to Neupro®. Physicians were requested to document the change of treatment at each recommended visit in the electronic Case Report Form (eCRF) considering their total clinical experience with this particular Restless Legs Syndrome (RLS) patients population. Documentation comprised changes in the RLS medication last prescribed, and the dosage of Neupro® and concomitant medications. The change of treatment regimen was entirely at the physicians' discretion.|From Baseline up to 28 days|The Analysis Population refers to the Eligibility Completer Set (ECS). The ECS is a subset of the Completer Set excluding patients with Parkinson’s disease and/or treated Polyneuropathy as concomitant disease identified by the preferred term (PT) of the MedDRA coding and patients treated with Neupro up to 4 weeks before Visit 1.|||participants|||Number
2683076|NCT01379703|Primary|Viral Load|Viral load is a direct measure of the viral burden by providing a count of the number of HIV-RNA copies in blood (plasma). The number of HIV-RNA copies in the blood was measured at baseline.|Baseline|Mean viral load is based on number of participants in each group who had laboratory results for viral load at baseline.|||Log10 copies per ml||Standard Deviation|Mean
2682176|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 6|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:~= Normal, not ill at all~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill subjects~A negative change from Baseline to Visit 6 indicates an improvement in CGI Item 1."|From Baseline up to 10 months|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.|||score on a scale||Standard Deviation|Mean
2682177|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 5|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:~= Normal, not ill at all~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill subjects~A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1."|From Baseline up to 7 months|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.|||score on a scale||Standard Deviation|Mean
2682178|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 4|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:~= Normal, not ill at all~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill subjects~A negative change from Baseline to Visit 4 indicates an improvement in CGI Item 1."|From Baseline up to 4 months|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.|||score on a scale||Standard Deviation|Mean
2682179|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 3|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:~= Normal, not ill at all~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill subjects~A negative change from Baseline to Visit 3 indicates an improvement in CGI Item 1."|From Baseline up to 28 days|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.|||score on a scale||Standard Deviation|Mean
2682180|NCT01386944|Primary|Change From Baseline (Visit 1) in Clinical Global Impression (CGI) (Item 1 - Severity of Illness) to Visit 2|"The CGI scales document a global assessment of the severity of RLS at single visits according to the treating physician. To this end the physician judges severity of disease by following a simple seven step severity rating scale:~= Normal, not ill at all~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill subjects~A negative change from Baseline to Visit 2 indicates an improvement in CGI Item 1."|From Baseline up to 7 days|The Analysis Population refers to the Full Analysis Set (FAS). The FAS is a subset of the Safety Set and consists of all patients who received treatment with Neupro at least once and had a Visit 1 and at least one post-Visit 1 measurement on the primary variable documented.|||score on a scale||Standard Deviation|Mean
2682181|NCT01386788|Primary|Serum Cyanide Levels||blood sampling within 2 hours after smoke inhalation|All recruited patients that met all inclusion criteria including blood sampling for cyanide serum level|||participants|||Number
2682182|NCT01386788|Primary|Overall Survival After 24 Hours|Number of participants who survived at 24 hours after smoke inhalation were reported.|24 hours||||participants|||Number
2682183|NCT01386684|Secondary|Percentage of Participants With Changes in Current Prostate Cancer Treatment Since Last Visit.|"Participants were asked Have there been any changes in the current prostate cancer treatment (not including Lupron) since last visit?; if Yes, was the change Initiation of new mediation/Change in Dose/Frequency or Discontinuation of medication. The percentage of subjects at each visit with a change in current prostate cancer treatment (Initiation or Change in Dose/Frequency or Discontinuation of Medication) is presented."|Months 3, 6, 12, 18, 24, 30, and 36|The number of participants with changes in current prostate cancer treatment since the last visit at given time point.|||percentage of participants|||Number
2682184|NCT01386684|Secondary|Treatment Compliance|Treatment compliance by participants was assessed as the number of missed injections since the last visit.|Months 3, 6, 12, 18, 24, 30, and 36|All participants with available data at given time point.|||missed injections||Standard Deviation|Mean
2682185|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Transportation Costs for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants with out of pocket expenses for transportation costs and with available data at given time point.|||dollars (CAD)||Standard Deviation|Mean
2682239|NCT01386658|Primary|Number of Participants With Clinically Significant Changes in Vital Signs|Vital signs included pulse rate, blood pressure, respiration rate, and temperature. The number of participants who reported clinically significant changes in vital signs were reported.|Pre-dose up to 97 days post-dose|Safety population consisted of participants who were treated with icatibant at least once during the study.|||Participants|||Count of Participants
2682186|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Health Care or Extra Help At Home for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants with out of pocket expenses for health care or extra help at home and with available data at given time point.|||dollars (CAD)||Standard Deviation|Mean
2682187|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Devices for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants with out of pocket expenses for medical devices and with available data at given time point.|||dollars (CAD)||Standard Deviation|Mean
2682188|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments for Medical Procedures or Laboratory Tests for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants with out of pocket expenses for payments for medical procedures or laboratory tests and with available data at given time point.|||dollars (CAD)||Standard Deviation|Mean
2682189|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Medical Procedures for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants with out of pocket expenses for medical procedures and with available data at given time point.|||dollars (CAD)||Standard Deviation|Mean
2682190|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Payments to Health Care Professionals for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants with out of pocket expenses for payments to health care professionals and with available data at given time point.|||dollars (CAD)||Standard Deviation|Mean
2682191|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Out of Pocket Expenses for Over-the-counter Medications for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants with out of pocket expenses for over-the-counter medications and with available data at given time point.|||dollars (CAD)||Standard Deviation|Mean
2682192|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Admissions to the Hospital for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants who were admitted to the hospital and with available data at given time point.|||admissions to the hospital||Standard Deviation|Mean
2682234|NCT01386658|Primary|Number of Participants Who Reported Injection Site Reactions (ISR) for Icatibant Exposure Number 1|The number of participants with injection site reactions (erythema, swelling, burning sensation, itching/pruritus, warm sensation, cutaneous pain, or other) that occured after initial icatibant administration was reported.|1 h post-dose on Day 1 up to 9 days post-dose|Safety population consisted of participants who were treated with icatibant at least once during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.|||Participants|||Count of Participants
2682193|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Were Admitted to the Hospital for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36||||Participants|||Count of Participants
2682194|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Visits For Any Other Medical Service for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants who had visited for any other medical service and with available data at given time point.|||visits for any other medical service||Standard Deviation|Mean
2682195|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used Any Other Medical Service for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36||||Participants|||Count of Participants
2682196|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Visits For Complementary/Alternate Therapy for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants who had visited complementary/alternate therapy and with available data at given time point.|||complementary/alternate therapy visits||Standard Deviation|Mean
2682197|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited Complementary/Alternate Therapy for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36||||Participants|||Count of Participants
2682198|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Times That an Ambulance Service Was Used for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants who had used an ambulance service and with available data at given time point.|||ambulance service uses||Standard Deviation|Mean
2682199|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Used an Ambulance Service for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36||||Participants|||Count of Participants
2682200|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Visits to A Hospital Emergency Room for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants who had visited a hospital emergency room and with available data at given time point.|||hospital emergency room visits||Standard Deviation|Mean
2682262|NCT01386632|Secondary|Local Response Rate for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||3 months|||||||
2682201|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Hospital Emergency Room for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36||||Participants|||Count of Participants
2682202|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Healthcare Professional for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants who had visited a healthcare professional and with available data at given time point.|||healthcare professional visits||Standard Deviation|Mean
2682203|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Healthcare Professional for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36||||Participants|||Count of Participants
2682204|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Visits With a Physician for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants who had visited a physician and with available data at given time point.|||physician visits||Standard Deviation|Mean
2682205|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Participants Who Visited a Physician for Prostate Cancer|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36||||Participants|||Count of Participants
2682206|NCT01386684|Secondary|Health Care Utilization and Health Economics Questionnaire: Number of Participants With Medical Insurance for Prescription Medications|The Health Care Utilization and Health Economics Questionnaire is a descriptive, self-administered series of questions aimed at measuring the patient's health care utilization and economic impact of the disease. The questionnaire was used to assess since the last visit the frequency of physician visits; utilization of other health care professionals; visits to clinics, emergency rooms, and hospitalizations related to prostate cancer; use of prescription and non-prescription medications for the management of prostate cancer were determined; and out of pocket expenses for medications and health care.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36|All participants with available data at given time point.|||Participants|||Count of Participants
2682207|NCT01386684|Secondary|International Index of Erectile Function (IIEF-5) Total Score: Change From Baseline to Each Visit|IIEF-5 is a 5-item, self-administered questionnaire assessing the presence and severity of erectile dysfunction. A score of 1 (very low) to 5 (very high) is awarded to each of the 5 questions. The IIEF-5 total score is a sum of the responses to the 5 items. Total scores range from 5 to 25, with higher scores indicating less dysfunction. Change in IIEF-5 was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates an increase in dysfunction.|Month 0 (Baseline) and Months 6, 12, 18, 24, 30, and 36||||units on a scale||Standard Error|Mean
2682208|NCT01386684|Secondary|Functional Assessment of Cancer Therapy Questionnaire - Prostate Cancer (FACT-P) Total Score: Change From Baseline to Each Visit|The FACT-P questionnaire is used with patients with prostate cancer to assess patient quality of life (QoL). FACT-P is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-P use a 5-point rating scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; and 4 = very much). The FACT-P total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-P was analyzed using repeated measures mixed effects general linear model (GLM). A negative change from baseline indicates decreased QoL.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36||||units on a scale||Standard Error|Mean
2682235|NCT01386658|Primary|Number of Participants With Adverse Events (AEs)|An AE was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in a clinical study, whether or not considered investigational product related.|From the start of study drug administration up to 97 days post-dose|Safety population consisted of participants who were treated with icatibant at least once during the study.|||Participants|||Count of Participants
2682209|NCT01386684|Secondary|Functional Assessment of Cancer Therapy Questionnaire - General (FACT-G) Total Score: Change From Baseline to Each Visit|The FACT-G questionnaire is used with patients of any tumor type to assess patient quality of life (QoL). FACT-G is a self-administered, 28-item questionnaire assessing physical, functional, social and emotional well-being, as well as patient satisfaction with treatment. All questions in the FACT-G use a 5-point rating scale (0 = Not at all; 1 = A little bit; 2 = Somewhat; 3 = Quite a bit; and 4 = Very much). The FACT-G total score is computed as the sum of the four subscale scores and has a possible range of 0-108. Higher scores indicate better QoL. Change in FACT-G was analyzed using repeated measures mixed effects general linear model (GLM). A positive change from baseline indicates improved QoL.|Month 0 (Baseline) and Months 3, 6, 12, 18, 24, 30, and 36||||units on a scale||Standard Error|Mean
2682210|NCT01386684|Secondary|Prostatic Specific Antigen (PSA) Levels at Each Visit|Serum PSA was assessed at each study visit.|Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36|All participants with available data at given time point.|||ng/ml||Standard Deviation|Mean
2682211|NCT01386684|Secondary|Prostatic Specific Antigen (PSA): Percentage of Participants With Serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL at Each Visit|Serum PSA was assessed at each study visit. The percentage of participants with serum PSA < 1 ng/mL, 1 to < 5 ng/mL, 5 to < 10 ng/mL, and ≥10 ng/mL are provided at each time point.|Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36|All participants with available date at given time point|||percentage of participants|||Number
2682212|NCT01386684|Secondary|Total Serum Testosterone: Time to Increase Over Castrate Levels|Total serum testosterone was assessed at each study visit. The time to increased total serum testosterone over the castrate levels (>1.7 nmol/L) are provided. The distribution of time to increase in total serum testosterone levels was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.|36 months|All participants who achieved castrate testosterone levels (≤1.7 nmol/L)|||months||Standard Error|Mean
2682213|NCT01386684|Secondary|Total Serum Testosterone Levels at Each Visit|Total serum testosterone was assessed at each study visit.|Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36|All participants with available data at given time point.|||nmol/L||Standard Deviation|Mean
2682214|NCT01386684|Secondary|Total Serum Testosterone: Percentage of Participants With ≤ 0.7 Nmol/L, > 0.7 to ≤ 1.7 Nmol/L, and > 1.7 Nmol/L at Each Visit|Total serum testosterone was assessed at each study visit. The percentage of participants with total serum testosterone ≤ 0.7 nmol/L, > 0.7 to ≤ 1.7 nmol/L, and > 1.7 nmol/L are provided at each time point.|Months 0 (Baseline), 3, 6, 12, 18, 24, 30, and 36|All participants with available data at given time point.|||percentage of participants|||Number
2682215|NCT01386684|Secondary|Castration Resistant Prostate Cancer (CRPC): Time to Event|CRPC defined as PSA > 2 ng/mL on at least 2 consecutive tests. The distribution of time to CRPC was estimated using Kaplan-Meier methodology. The point estimate and standard error of the distribution are provided.|36 months|All participants who achieved PSA levels ≤2 ng/mL|||months||Standard Error|Mean
2682216|NCT01386684|Secondary|Castration Resistant Prostate Cancer (CRPC): Number of Participants|CRPC defined as PSA > 2 ng/mL on at least 2 consecutive tests.|36 months|All participants who achieved PSA levels ≤ 2 ng/mL|||participants|||Number
2682217|NCT01386684|Primary|Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to a Change to an Absolute Value of PSA > 2 ng/mL on at Least 2 Consecutive Tests|A second definition of PFS was used due to changes in the definition of biochemical progression: the time from patient recruitment to a change to an absolute value of PSA > 2 ng/mL on at least 2 consecutive tests, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.|36 months||||months||Standard Error|Mean
2682218|NCT01386684|Primary|Progression-free Survival (PFS) Defined as the Time From Patient Recruitment to Biochemical Progression Based on Doubling of Prostate Specific Antigen (PSA) Velocity or PSA > 5.0|PFS defined as the time from patient recruitment to biochemical progression based on doubling of prostate specific antigen (PSA) velocity or PSA > 5.0, objective tumor progression (RECIST criteria), or death. The distribution of PFS was estimated using Kaplan-Meier methodology. The point estimate and standard error (SE) of the distribution are provided.|36 months||||months||Standard Error|Mean
2682219|NCT01386658|Secondary|Number of Participants With Worsened Intensity of Clinical Hereditary Angioedema (HAE) Symptoms Between 2 and 4 Hours After Treatment With Icatibant Exposure Number 2 and 3|The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5- point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). The number of participants with a worsened severity of HAE symptoms at 4 hours post-dose from 2 hours post-dose were reported.|From 2 hours post-dose to 4 hours post-dose|Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. The number of participants analyzed signifies participants evaluable for this endpoint.|||Participants|||Count of Participants
2682220|NCT01386658|Secondary|Number of Participants With Worsened Intensity of Clinical Hereditary Angioedema (HAE) Symptoms Between 2 and 4 Hours After Treatment With Icatibant Exposure Number 1|The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5- point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). The number of participants with a worsened severity of HAE symptoms at 4 hours post-dose from 2 hours postdose were reported.|From 2 hours post-dose to 4 hours post-dose|Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who evaluable for this endpoint.|||Participants|||Count of Participants
2682236|NCT01386658|Primary|Number of Participants Who Reported Presence of Anti-icatibant Antibodies|The number of participants who reported anti-icatibant antibodies were reported.|Pre-dose up to 97 days post-dose|Safety population consisted of participants who were treated with icatibant at least once during the study.|||Participants|||Count of Participants
2682221|NCT01386658|Secondary|Time to Use of Rescue Medication for the Treatment of Symptoms of the Hereditary Angioedema (HAE) Attack Following Study Drug Administration|"Rescue medication was any medication used after the administration of icatibant which, in the opinion of the investigator, was immediately necessary to alleviate acute symptoms which are judged by the investigator as resultant from the current HAE attack. Time to first use of rescue medication prior to the onset of symptom relief was calculated from the time of study drug administration to the first use of rescue medication prior to the onset of symptom relief. This analysis was not performed since as per protocol, This analysis will only be performed if there are at least 5 participants for a given attack who used rescue medication prior to attaining symptom relief."|From the start of study drug administration up to 52 hours post-dose|Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.|||h||95% Confidence Interval|Median
2682222|NCT01386658|Secondary|Time to Minimum Symptom for Faces, Legs, Activity, Cry, and Consolability (FLACC) Scores|Time to minimum symptoms was defined as the duration of time in hours from study drug administration to the earliest time at which the total post-treatment score improved to zero. Participants of 4 years age and younger underwent investigator assessment of HAE-related pain (cutaneous, abdominal, and laryngeal) using the FLACC comportmental pain scale. Each of the 5 categories was scored from 0 to 2. (F) Face: 0 (no particular expression/smile) - 2 (frequent to constant frown clenched jaw quivering chin); (L) Legs: 0 (normal position/relaxed) - 2 (kicking/legs drawn up); (A) Activity: 0 (lying quietly, normal position, moves easily) - 2 (arched rigid/jerking); (C) Cry: 0 (No cry [awake/asleep]) - 2 (crying steadily/screams/sobs or frequent complaints); (C) Consolability: 0 (content/relaxed) - 2 (difficult to console/comfort), resulting in a total score between 0 and 10.|From start of study drug administration up to 8.5 hours post-dose|Participants from efficacy population with FLACC data.|||h||95% Confidence Interval|Median
2682223|NCT01386658|Secondary|Time to Minimum Symptom for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 2 and 3|Time to minimum symptoms was defined as the duration of time in hours from study drug administration to the earliest time at which post-treatment score improved to zero (or no pain). Participants of 4 years of age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). Time to minimum symptom for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.|From start of study drug administration up to 28 hours post-dose|Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants with FPS-R data.|||h||95% Confidence Interval|Median
2682224|NCT01386658|Secondary|Time to Minimum Symptom for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 1|Time to minimum symptoms was defined as the duration of time in hours from study drug administration to the earliest time at which post-treatment score improved to zero (or no pain). Participants of 4 years of age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). Time to minimum symptom for participants who received initial icatibant administration was reported.|From start of study drug administration up to 52 hours post-dose|Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants with FPS-R data.|||h||95% Confidence Interval|Median
2682225|NCT01386658|Secondary|Time to Minimum Symptoms for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 2 and 3|Time to minimum symptom was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which all symptoms were either mild or absent for the investigator-reported symptom score. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5-point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). Time to minimum symptom for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.|From start of study drug administration up to 12 hours post-dose|Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.|||h||95% Confidence Interval|Median
2682226|NCT01386658|Secondary|Time to Minimum Symptoms for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 1|Time to minimum symptom was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which all symptoms were either mild or absent for the investigator-reported symptom score. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5-point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). Time to minimum symptom for participants who received initial icatibant administration was reported.|From start of study drug administration up to 8.5 hours post-dose|Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.|||h||95% Confidence Interval|Median
2682237|NCT01386658|Primary|Number of Participants With Clinically Significant Changes in Clinical Laboratory Evaluations|Clinical laboratory evaluations included clinical chemistry (including liver function tests), hematology, urinalysis. The number of participants who reported clinically significant changes in clinical laboratory evaluations were reported.|Pre-dose up to 97 days post-dose|Safety population consisted of participants who were treated with icatibant at least once during the study.|||Participants|||Count of Participants
2684385|NCT01368497|Secondary|Proportion of Participants With HBsAg Seroconversion||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
2682227|NCT01386658|Secondary|Time to Onset of Symptom Relief (TOSR) for Faces, Legs, Activity, Cry, and Consolability (FLACC) Scores|The TOSR was defined as the earliest time at which a 20% improvement was seen in the total post-treatment score. Participants of 4 years age and younger underwent investigator assessment of HAE-related pain (cutaneous, abdominal, and laryngeal) using the FLACC comportmental pain scale. Each of the 5 categories was scored from 0 to 2. Face(F): 0 (no particular expression/smile) - 2 (frequent to constant frown clenched jaw quivering chin); Legs(L): 0 (normal position/relaxed) - 2 (kicking/legs drawn up); Activity(A): 0 (lying quietly, normal position, moves easily) - 2 (arched rigid/jerking); Cry(C): 0 (No cry [awake/asleep]) - 2 (crying steadily/screams/sobs or frequent complaints); Consolability(C): 0 (content/relaxed) - 2 (difficult to console/comfort), resulting in a total score between 0 and 10.|From start of study drug administration up to 8.5 hours post-dose|Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants of 4 years and younger with FLACC data.|||h||95% Confidence Interval|Median
2682228|NCT01386658|Secondary|Time to Onset of Symptom Relief (TOSR) for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 2 and 3|The TOSR was defined as the earliest time at which the post-treatment score improved by at least one level. Participants of 4 years age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). TOSR for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.|From start of study drug administration up to 28 hours post-dose|Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants with FPS-R data.|||h||95% Confidence Interval|Median
2682229|NCT01386658|Secondary|Time to Onset of Symptom Relief (TOSR) for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 1|The TOSR was defined as the earliest time at which the post-treatment score improved by at least one level. Participants of 4 years age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). TOSR for participants who received initial icatibant administration was reported.|From start of study drug administration up to 52 hours post-dose|Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants with FPS-R data.|||h||95% Confidence Interval|Median
2682230|NCT01386658|Secondary|Time to Onset of Symptom Relief (TOSR) for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 2 and 3|The TOSR was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which there was at least a 20% improvement in the composite (or average) post-treatment symptom score with no worsening of any single component score. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE using the following 5-point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). TOSR for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.|From start of study drug administration up to 12 hours post-dose|Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who received subsequent icatibant exposures 2 and 3.|||h||95% Confidence Interval|Median
2682231|NCT01386658|Secondary|Time to Onset of Symptom Relief (TOSR) for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 1|The TOSR was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which there was at least a 20 percent (%) improvement in the average post-treatment symptom score with no worsening of any single component score for the initial icatibant exposure. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of hereditary angioedema (HAE) using the following 5-point scale: 0=none (absence of symptoms), 1=mild (no to mild interference with daily activities), 2=moderate (moderate interference with daily activities), 3=severe (severe interference with daily activities) and 4=very severe (very severe interference with daily activities). TOSR for participants who received initial icatibant administration was reported.|From start of study drug administration up to 8.5 hours post-dose|Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.|||h||95% Confidence Interval|Median
2682232|NCT01386658|Primary|Number of Participants With Clinically Significant Changes in Reproductive Hormones|Reproductive hormone levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, and progesterone in females, and FSH, LH, and testosterone in males were measured. The number of participants with clinically significant changes in reproductive hormones was reported.|Pre-dose up to 97 days post-dose|Safety population consisted of participants who were treated with icatibant at least once during the study.|||Participants|||Count of Participants
2682233|NCT01386658|Primary|Number of Participants Who Reported Injection Site Reactions (ISR) for Icatibant Exposure Number 2 and 3|The number of participants with injection site reactions (erythema, swelling, burning sensation, itching/pruritus, warm sensation, cutaneous pain, or other) that occurred after subsequent icatibant administration by study-site personnel (health care practitioner [HCP] administration) or by caregiver/self (caregiver administration) was reported. In the below table, E-2 refers to icatibant exposure 2 and E-3 refers to icatibant exposure 3.|1 h post-dose up to 9 days post-dose|Safety population consisted of participants who were treated with icatibant at least once during the study. Here the number of participants analyzed signifies participants who received subsequent icatibant exposures 2 and 3.|||Participants|||Count of Participants
2682666|NCT01382225|Secondary|Percentage Change From Baseline in Schirmer I Score|The investigator placed a paper strip on the eye under the lower lid and left it in place for 5 minutes. The Schirmer I Score was the length of the strip wetted by the tears (0-35 millimeters). A more positive percentage change indicates a greater amount of improvement.|Baseline, up to Day 14|Modified Intent-to-Treat|||Percent change||Standard Deviation|Mean
2682240|NCT01386658|Primary|Elimination Half-life (t1/2) of a Single Subcutaneous (SC) Dose of Icatibant|Elimination half-life (t1/2) of a single SC dose of icatibant was reported.|Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1|The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.|||h||Standard Deviation|Mean
2682241|NCT01386658|Primary|Volume of Distribution (Vz/F) of a Single Subcutaneous (SC) Dose of Icatibant|Volume of distribution (Vz/F) of a single SC dose of icatibant was reported.|Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1|The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.|||Liters (L)||Standard Deviation|Mean
2682242|NCT01386658|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of a Single Subcutaneous (SC) Dose of Icatibant|Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of a single SC dose of icatibant was reported.|Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1|The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.|||h*ng/mL||Standard Deviation|Mean
2682243|NCT01386658|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to 6 Hours Post-dose (AUC0-t) of a Single Subcutaneous (SC) Dose of Icatibant|Area under the plasma concentration-time curve from time zero to 6 hours post-dose (AUC0-t) of a single SC dose of icatibant was reported.|Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1|The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.|||h*ng/mL||Standard Deviation|Mean
2682244|NCT01386658|Primary|Area Under the Plasma Concentration-time Curve From Time Zero to 4 Hours Post-dose (AUC0-4) of a Single Subcutaneous (SC) Dose of Icatibant|Area under the plasma concentration-time curve from time zero to 4 hours post-dose (AUC0-4) of a single SC dose of icatibant was reported.|Pre-dose; 0.25, 0.5, 0.75, 1, 2, and 4 hours post-dose on Day 1|The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.|||Hour*nanogram per milliliter (h*ng/mL)||Standard Deviation|Mean
2682245|NCT01386658|Primary|Total Plasma Clearance (CL/F) of a Single Subcutaneous (SC) Dose of Icatibant|Total plasma clearance (CL/F) of a single SC dose of icatibant was reported.|Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1|The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.|||Milliliters per minute (mL/min)||Standard Deviation|Mean
2682246|NCT01386658|Primary|Maximum Plasma Concentration (Cmax) of a Single Subcutaneous (SC) Dose of Icatibant|Maximum plasma concentration (Cmax) of a single SC dose of icatibant was reported.|Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1|The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration-time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.|||Nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2682247|NCT01386658|Primary|Time to Peak Concentration (Tmax) of a Single Subcutaneous (SC) Dose of Icatibant|Time to peak concentration (Tmax) of a single SC dose of icatibant was reported.|Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1|Pharmacokinetic (PK) population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration-time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.|||Hour (h)||Standard Deviation|Mean
2682248|NCT01386632|Secondary|Relative Toxicities for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||5 years|||||||
2682249|NCT01386632|Secondary|Relative Toxicities During Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||End of treatment|||||||
2682250|NCT01386632|Secondary|Relative Toxicities for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||3 months|||||||
2682251|NCT01386632|Secondary|Relative Toxicities for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||2 years|||||||
2682252|NCT01386632|Secondary|HPV Status- Correlate These Findings With Toxicity and Outcome (Exploratory Analysis).||3 months|||||||
2682253|NCT01386632|Secondary|Immune Response and Correlate These Findings With Toxicity and Outcome (Exploratory Analysis).||3 months|||||||
2682254|NCT01386632|Secondary|Health-related Quality of Life Among Study Patients by Treatment Arm .||5 year|||||||
2682255|NCT01386632|Secondary|Health-related Quality of Life Among Study Patients by Treatment Arm.||2 year|||||||
2682256|NCT01386632|Secondary|Health-related Quality of Life Among Study Patients by Treatment Arm .||1 year|||||||
2682257|NCT01386632|Secondary|Health-related Quality of Life Among Study Patients by Treatment Arm.||Completion of Treatment|||||||
2682258|NCT01386632|Secondary|Overall Survival for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||5 year|||||||
2682259|NCT01386632|Secondary|Overall Survival for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||2 years|||||||
2682260|NCT01386632|Secondary|Overall Survival for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||1 year|||||||
2682261|NCT01386632|Secondary|Local Response Rate for Locally Advanced Head and Neck Squamous Cell Carcinoma Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.||1 year|||||||
2682263|NCT01386632|Secondary|Two-year and Five-year Progression-free Survival Rate in Locally Advanced Head and Neck Squamous Cell Carcinoma in Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.|Progression will be determined using RECIST 1.1 definition of 20% increase in the sum of the diameters of target lesions, in either primary or nodal lesions or the appearance of one or more new lesion(s) and/or unequivocal progression of existing non-target lesions.|Year 5||2020-06-30|06/2020||||
2682264|NCT01386632|Secondary|Two-year Progression-free Survival Rate in Locally Advanced Head and Neck Squamous Cell Carcinoma in Patients Receiving Concurrent Cisplatin, Radiation Therapy, and DCA.|"Outcome of tumor change will be compared in two separate ways. First, change in measured tumor size at 8 weeks and 3 months will be compared using standard linear models methods (using appropriate transformation to reduce statistical skew).~Progression was determined using RECIST 1.1 definition of 20% increase in the sum of the diameters of target lesions, in either primary or nodal lesions or the appearance of one or more new lesion(s) and/or unequivocal progression of existing non-target lesions."|Year 2||||percentage of patients||95% Confidence Interval|Number
2682265|NCT01386632|Primary|Percentage of Participants Who Experienced Adverse Events During Treatment.|Percentage of Participants Who Experienced Adverse Events During Treatment including but are not limited to mucositis, leucopenia, neuropathy, and treatment breaks. This will be done according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0|Adverse events (AE) will be assessed from the time the subject begins the study until the 30-days after receiving the last dose of the study medication.||||percentage of patients||95% Confidence Interval|Number
2682266|NCT01386606|Other Pre-specified|Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.|The area under the curve for plasma concentration over time from zero to 24 hours (AUC0-24).|Week 6|PK population|||ng*h/mL||Standard Deviation|Mean
2682267|NCT01386606|Other Pre-specified|Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.|The Tmax for plasma concentration.|Week 6|PK population|||h||Standard Deviation|Mean
2682268|NCT01386606|Secondary|Change in Follicle Stimulating Hormone (FSH)|Changes in morning FSH after continuous dosing|Baseline, Week 2, Week 4, Week 6|ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.|||mIU/mL||Standard Deviation|Mean
2682269|NCT01386606|Other Pre-specified|Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.|The Cmax for plasma concentration.|Week 6|PK population|||ng/mL||Standard Deviation|Mean
2682270|NCT01386606|Post-Hoc|Morning Testosterone Correlated With Serial Testosterone.|"9 AM morning testosterone correlated with Week 6 serial testosterone Cavg, Cmin, and Cmax.~If a subject did not have a Week 6 serial testosterone Cavg, Cmin, or Cmax then they were not included for that particular correlation calculation."|Week 6|All Androxal subjects with Week 6 serial testosterone measurements.|||Number of Subjects|||Number
2682271|NCT01386606|Secondary|Change in Leuteinizing Hormone (LH)|Changes in morning LH after continuous dosing|Baseline, Week 2, Week 4, Week 6|ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.|||mIU/mL||Standard Deviation|Mean
2682272|NCT01386606|Primary|24 Hour Average and Maximum Testosterone Concentration|"The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment.~Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24."|Baseline and Week 6|ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.|||ng/dL||Standard Deviation|Mean
2682273|NCT01386554|Secondary|Percentage of Participants With Sustained Remission|The participant's response was considered the average of the two PCR values from the 24-hour urine collections at Visit 8 (Week 24).|At Visit 9 (Week 28)|ITT Population|||Participants|||Count of Participants
2682274|NCT01386554|Primary|Percentage of Participants With Complete or Partial Remission in Proteinuria at 24 Weeks|The participant's response was considered the average of the two PCR values from the 24-hour urine collected at Visit 8 (Week 24). Urine protein creatinine ratio (uPCR) was used to assess remission (partial and complete). Complete remission = uPCR < 0.3 g/g; partial remission = uPCR < 50% of baseline uPCR and > 0.3 g/g but < 3.0 g/g.|At Visit 8 (Week 24)|ITT Population included all randomized participants who received ≥ 1 dose of study mediation and who contributed any efficacy data in the study.|||Participants|||Count of Participants
2682275|NCT01386528|Secondary|Incidence of Inhibitors Against FIX (Coagulation Factor Nine)|Number of patients with inhibitory antibodies|During the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) and every 4 weeks after post-operative period (day 1 to day 13)|The full analysis set consisted of all patients exposed to nanacog beta pegol.|||patients|||Number
2682276|NCT01386528|Secondary|Incidence of Serious Adverse Events (SAE)|The number of serious adverse events per patient years of exposure, reported during the trial period. Number is the only available option here, the data presented are rate of AEs.|During the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) until 4 weeks after post-operative period (day 1 to day 13)|The safety analysis set consisted of all patients exposed to nanacog beta pegol.|||Events per patient year of exposure|||Number
2682277|NCT01386528|Secondary|Incidence of Adverse Events (AEs)|The number of adverse events per patient years of exposure, reported during the trial period. Number is the only available option here, the data presented are rate of AEs.|during the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) until 4 weeks after post-operative period (day 1 to day 13)|The safety analysis set consisted of all patients exposed to nanacog beta pegol.|||events per patient year of exposure|||Number
2682278|NCT01386528|Secondary|Haemoglobin Pre- and Post-surgery Start|The mean pre-surgery and post surgery haemoglobin level.|0, 1 hour, 24 hours.|The full analysis set consisted of all patients exposed to nanacog beta pegol.|||mmol/L||Standard Deviation|Mean
2682279|NCT01386528|Secondary|Transfusion Requirements (Fulfilling Transfusion Criteria)|Mean quantity of transfusion during surgery (the time from knife to skin until last stitch) and the postoperative period (Day 1-13).None of the patients required transfusions beyond Day 6 hence no values presented for days 7-13.|during surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)|The full analysis set consisted of all patients exposed to nanacog beta pegol.|||mL||Standard Deviation|Mean
2682280|NCT01386528|Secondary|Consumption of NNC-0156-0000-0009 (U/kg Body Weight)|Mean consumption of nonacog beta pegol (U/kg) used for treatment per patient before surgery, during surgery (the time from knife to skin until last stitch) and post-operative period.|During surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)|The full analysis set consisted of all patients exposed to nanacog beta pegol.|||U/Kg||Standard Deviation|Mean
2682281|NCT01386528|Primary|Haemostatic Effect During Surgery Evaluated by the Four-point Response Scale (Excellent, Good, Moderate, Poor)|"Haemostatic effect during surgery was evaluated immediately after surgery (last stitch) using a fourpoint response scale:~- Four-point response scale: Excellent, good, moderate, poor. The evaluation was done by the surgeon, anaesthesiologist and/or investigator based on experience as follows:~Excellent: Better than expected/predicted in this type of procedure.~Good: As expected in this type of procedure.~Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.~Poor: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required."|At the day of surgery|The full analysis set consisted of all patients exposed to nanacog beta pegol.|||Haemostatic responses|||Number
2682282|NCT01386125|Primary|Change From Baseline in Total Polyp Size Score|An endoscopic nasal examination was performed by the Investigator. Bilateral nasal polyps were scored as follows for each notril (left and right): 0=no polyps, 1=polyps in middle meatus not reaching below inferior border of middle turbinate, 2=polyps reaching below inferior border of middle turbinate but not inferior border of inferior turbinate, 3=large polyps reaching to or below the lower borders of the inferior turbinate or polyps medial to the middle turbinate. Total polyp size score ranged from 0 to 6 (scored 0 to 3 for each nostril), with a lower score indicating smaller-sized polyps. LS Mean Change from Baseline = LS Mean Score for Week 16 - LS Mean Score for Baseline.|Baseline and Week 16|The FAS population consisted of all randomized participants who received at least one dose of study treatment and who had a baseline and at least one post-baseline efficacy assessment.|||score on a scale||Standard Error|Least Squares Mean
2682283|NCT01386125|Primary|Change From Baseline in Congestion/Obstruction Score|At Baseline, the Investigator and participant jointly evaluated the signs and symptoms of congestion/obstruction. After Baseline, participants scored the signs and symptoms of congestion/obstruction every morning immediately prior to dosing using a morning instantaneous congestion/obstruction score. This score reflected the participant's condition at that time (instantaneous) and ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3= severe), with a lower score indicating less congestion/obstruction. Congestion/obstruction scores were averaged over Weeks 1-4 of the treatment period. Data are compared using Least Square (LS) Means. LS Mean Change from Baseline = LS Mean Score averaged over Weeks 1-4 - LS Mean Score for Baseline.|Baseline and Weeks 1-4|The Full Analysis Set (FAS) population consisted of all randomized participants who received at least one dose of study treatment and who had a baseline and at least one post-baseline efficacy assessment.|||score on a scale||Standard Error|Least Squares Mean
2682284|NCT01386008|Secondary|Investigator Fit Preference|Investigator Fit Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)|V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)|Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.|||participants|||Number
2682285|NCT01386008|Primary|Ocular Health|Ocular health determined by biomicroscopy recorded on a severity scale (0-4) for change from baseline over 30 days.|Change from baseline over 30 days measured at V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)|Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. Change from baseline V1 over 30 days V4 cannot be analyzed.||||||
2682286|NCT01386008|Primary|Subjective Comfort Preference - Participants Preference Response|Subjective responses of participants administered by questionnaire and measured on a linear scale (0-100) measured at each visit.|V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)|Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.|||participants|||Number
2682287|NCT01386008|Secondary|Investigator Surface Preference|Investigator Surface Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)|V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)|Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.|||participants|||Number
2682288|NCT01385995|Secondary|Mean and Standard Deviation of Insulin Sensitivity Index (ISI(0,120)) With Therapeutic CPAP vs. Sham|Insulin Sensitivity Index derived from the Gutt Index, uses the plasma glucose and insulin concentration from fasting (0 min) and 120-min samples from the OGTT, to calculate (Metabolic Clearance Rate)/log (Mean Serum Insulin). The range of possible values is based on the subset ranges of fasting and oral glucose tolerance test (OGTT) insulin and fasting and OGTT glucose, which calculate to be a range of 1.6 to 206.8. An increase in the ISI (0,120) indicates an improvement in the insulin sensitivity.|20 Weeks||||units on a scale||Standard Deviation|Mean
2682289|NCT01385995|Secondary|Mean and Standard Deviation of Indices of Insulin Resistance With Therapeutic CPAP vs. Sham|Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) with therapeutic CPAP vs. Sham CPAP|20 weeks|All subjects with available fasting insulin, glucose measurements|||percentage of beta cell function||Standard Deviation|Mean
2682290|NCT01385995|Secondary|Mean and Standard Deviation of Insulin Indices After Therapeutic CPAP vs. Sham|The data for fasting and 2 hour Insulin (iIU/dL) are presented according to therapeutic CPAP vs. Sham CPAP.|20 weeks|All subjects with available fasting and and 2-hour insulin measurements are included.|||iIU/dL||Standard Deviation|Mean
2682291|NCT01385995|Secondary|Mean and Standard Deviation of Glucose Indices After Therapeutic CPAP vs. Sham|Reported values include: fasting glucose (mg/dL), 2 hour Oral Glucose Tolerance Test (OGTT) (mg/dL)|20 weeks||||mg/dL||Standard Deviation|Mean
2682292|NCT01385995|Primary|Number of Subjects With Normalization of Impaired Glucose Tolerance (IGT)|Number of subjects who experienced normalization of the mean 2-hour oral glucose tolerance test (OGTT) in the overall sample undergoing therapeutic CPAP vs. sham CPAP. (2-hour OGTT glucose< 140 mg/dL)|20 weeks|All available oral glucose tolerance test data was analyzed for the total sample.|||subjects|||Number
2682293|NCT01385748|Other Pre-specified|Overall Treatment Compliance According to the Patient Diary|"All participants complete a daily questionnaire during the active phase (radiotherapy). Compliance = [ number of tablets / (end date of treatment - start date treatment + 1 ) ] * 100. The number of tablets is the number of days with a tablet applied and treatment start and end dates are the first and last dates of the patient diary with a tablet applied."|8 weeks|Participants with evaluable data.|||percentage of compliance||Standard Deviation|Mean
2682294|NCT01385748|Other Pre-specified|Salivary Flow Assessment Using the National Cancer Institute-Common Terminology Criteria (NCI-CTC) for Xerostomia: Time to First Grade 2 or Higher|Salivary flow was assessed and scored by the investigator weekly using the NCI-CTC scale for xerostomia for up to 8 weeks during the active phase (radiotherapy). Time to appearance of Grade 2 or higher on the following 4-point scoring scale is reported: 0 = normal; 1 = symptomatic (dry or thick saliva) without significant dietary alteration (unstimulated saliva flow greater than 0.2 mL/minute); 2 = symptomatic and significant oral intake alterations (e.g. copious water, other lubricants, diet limited to purees and/or soft, moist foods) (unstimulated saliva 0.1 to 0.2 mL/minute); and 3 = symptoms leading to inability to adequately aliment orally, intravenous fluids, tube feedings, or total parenteral nutrition indicated (unstimulated saliva < 0.1 mL/minute).|8 weeks|Two of the 183 participants received study treatment but withdrew early without any safety assessments (1 in the clonidine Lauriad 50 μg group and 1 in the clonidine Lauriad 100 μg group). The safety population therefore included 181 participants.|||weeks||95% Confidence Interval|Median
2682295|NCT01385748|Other Pre-specified|The Overall Incidence of Grade 3/4 Mucositis During the Active Phase.|The presence of grade 3 or 4 oral mucositis on the World Health Organization (WHO) oral mucositis severity scale was assessed twice weekly during the active phase (radiotherapy) by a trained radiation oncologist or an ear nose and throat specialist who took into account the field of radiation treatment. WHO score 3 = ulcers, extensive erythema, and the inability of the participant to swallow a solid diet; WHO score 4 = mucositis to the extent that alimentation was not possible.The number of participants with at least one Grade 3 or Grade 4 mucositis score during the active phase is reported.|8 weeks|Missing = participants without a WHO score during the active phase|||participants|||Number
2682296|NCT01385748|Other Pre-specified|The Maximum Severity of Oral Mucositis|Participants were assessed using the World Health Organization (WHO) oral mucositis severity scale twice weekly during the active phase (radiotherapy) by a trained radiation oncologist or an ear nose and throat specialist who took into account the field of radiation treatment. The WHO scores were as follows: 0 = None; 1 = oral soreness, erythema; 2 = oral erythema, ulcers, solid diet tolerated; 3 = oral ulcers, liquid diet only; 4 = oral alimentation impossible. The maximum severity was the maximum score reported during the active phase.|8 weeks||||participants|||Number
2682297|NCT01385748|Other Pre-specified|Time to Onset of Severe Oral Mucositis|Time to onset is the duration until first Severe Oral Mucositis. Severe Oral Mucositis was defined as a Grade 3 or Grade 4 score on the World Health Organization (WHO) oral mucositis severity scale. Participants were assessed twice weekly during the active phase (radiotherapy) by a trained radiation oncologist or an ear nose and throat specialist who took into account the field of radiation treatment. WHO score 3 = ulcers, extensive erythema, and the inability of the participant to swallow a solid diet; WHO score 4 = mucositis to the extent that alimentation was not possible.|8 weeks||||weeks||95% Confidence Interval|Median
2682298|NCT01385748|Secondary|Overall Survival|After the end-of study visit, the investigator center collects OS follow-up data for each patient who has consented to participate in the follow-up data collection. the OS follow-up period was still ongoing at time of the primary analysis and ended in Nov 2016. The analysis was condicted on the ITT population. The overall survival was evaluate every 6 months after last subject completed in patients who has consented to participate .|2 years|The population for the 2-year OS follow-up was the ITT defined as all patients who received at least 1 dose of investigational drug.|||months||95% Confidence Interval|Median
2682299|NCT01385748|Secondary|Opioid Use: Minimal Total Cumulative Dose Administered (Median, Range)|Opioid use was recorded twice weekly for up to 8 weeks during the active phase (radiotherapy). The sum of non-missing total cumulative doses across all class 3 analgesics recorded for the considered participant is reported.|8 weeks|Participants with at least one use of an opioid during the active phase with evaluable data.|||morphine dose equivalent||Full Range|Median
2682300|NCT01385748|Secondary|Opioid Use: Minimal Total Cumulative Dose Administered (Mean, Standard Deviation)|Opioid use was recorded twice weekly for up to 8 weeks during the active phase (radiotherapy). The sum of non-missing total cumulative doses across all class 3 analgesics recorded for the considered participant is reported.|8 weeks|Participants with at least one use of an opioid during the active phase with evaluable data.|||morphine dose equivalent||Standard Deviation|Mean
2682301|NCT01385748|Secondary|At Least One Opioid Use (Class 3 Analgesic)|Opioid use was recorded twice weekly during the active phase (radiotherapy)|8 weeks||||participants|||Number
2682302|NCT01385748|Primary|Cumulative Radiation Dose at Which Severe Oral Mucositis (World Health Organization [WHO] Score ≥ 3) Was First Observed|The primary endpoint planned in the protocol was the percentage of participants with an oral mucositis score greater than or equal to 3 using the WHO oral mucositis severity scale at a cumulative radiation dose of 50 Gy. This was modified by protocol amendment to the cumulative radiation dose at which a WHO score greater than or equal to 3 was first observed. This change was made to account for the fact that in real practice most patients receive a cumulative dose between 60 and 70 Gy. The presence of grade 3 or 4 oral mucositis was assessed twice weekly during the active phase (radiotherapy) by a trained radiation oncologist or an ear nose and throat specialist who took into account the field of radiation treatment. WHO score 3 = oral ulcers, liquid diet only; WHO score 4 = oral alimentation impossible. Each assessment was associated with the actual cumulative dose of radiotherapy.|8 weeks|The analysis was conducted on the Intent to treat population, defined as all participants who received at least one dose of investigational drug.|||Cumulative radiation dose (Gy)||95% Confidence Interval|Median
2682316|NCT01385566|Primary|Number of Participants Reporting an Adverse Experience (AE)|"An AE is defined as any unfavorable and unintended change in the~structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience."|Up to 42 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination|||participants|||Number
2682303|NCT01385696|Secondary|Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2|"The correct use of devices will be assessed measuring the errors made by patients when using each device after 2 weeks of daily practice (visit 2).~Critical error is defined as the one that compromise the potential benefit of the treatment such as those that impede drug deposition in the lungs or delivery of sufficient dose."|14 days|ITT: all randomized patients who used both devices at least once and expressed a preference for either or neither inhaler. 24 patients from the safety population (12 each arm) received the incorrect treatment allocation and were excluded from the ITT population. Missing data were handled via the observed cases approach.|||Percentage of Patients|||Number
2682304|NCT01385696|Secondary|Mean Overall Satisfaction With Genuair and Handihaler at Visit 2|The patient will be asked to rate the overall satisfaction with each device using a Likert-type scale (from 1 [very dissatisfied] to 5 [very satisfied]) after 2 weeks of daily practice (visit 2)|14 days|ITT: all randomized patients who used both devices at least once and expressed a preference for either or neither inhaler. 24 patients from the safety population (12 each arm) received the incorrect treatment allocation and were excluded from the ITT population. Missing data were handled via the observed cases approach.|||Units on a scale (1-5)||95% Confidence Interval|Mean
2682305|NCT01385696|Primary|Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2|Patients will be asked to answer which device they prefer after 2 weeks of daily practice (visit 2)|14 days|ITT: all randomized patients who used both devices at least once and expressed a preference for either or neither inhaler. 24 patients (12 each arm) received the incorrect treatment allocation and were excluded from the ITT population. Missing data was handled via the observed cases approach.|||Percentage of Patients|||Number
2682306|NCT01385644|Secondary|Percentage Change in Lung Function as Assessed by DLCO Compared to Baseline|DLCO was measured as a percentage of predicted, and the percentage change between 6 months post-infusion and baseline is reported.|6 months post MSC infusion||||percentage of baseline||Inter-Quartile Range|Median
2682307|NCT01385644|Secondary|Percentage Change in 6 Minute Walk Distance Compared to Baseline|At 6 months 6 Minute Walk Distance was mesured and compared as a percentage to baseline|Baseline and 6 months post MSC infusion||||percentage of baseline||Inter-Quartile Range|Median
2682308|NCT01385644|Secondary|Percentage Change in Lung Function as Assessed by FVC Compared to Baseline|Forced Vital Capacity (FVC) was measured and reported as a percentage of predicted and comapred from 6 months post-infusion to baseline|6 months post MSC infusion||||percentage of baseline||Inter-Quartile Range|Median
2682309|NCT01385644|Primary|Number of Participants Who Demonstrated Acute Adverse Events Following Infusion|Acute adverse events following infusion was defined as the development of anaphalaxis and/or a 25% increase or decrease from baseline of hemodynamic measurements.|4 hours post-infusion|Data from 8 participants was analyzed. (4 from each group)|||participants|||Number
2682310|NCT01385579|Primary|Completion of a Colorectal Cancer Screening|Patients who have documentation within the electronic health record of completion of a guideline approved form of colorectal cancer screening (colonoscopy, sigmoidoscopy, or fecal occult blood testing (FOBT)) within 4 months of the initiation of the outreach intervention (by June 30, 2010)|within 4 months of the initiation of outreach (by June 30, 2010)||||participants|||Number
2682311|NCT01385566|Primary|Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like)|Non-injection-site rashes were examined by a study physician. Rashes suspected to be varicella/varicella-like or herpes zoster/herpes zoster-like were sampled for verification by polymerase chain reaction.|Up to 42 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination|||participants|||Number
2682312|NCT01385566|Primary|Number of Participants Reporting Systemic Adverse Experiences|Systemic AEs included all reported AEs except injection-site AEs|Up to 42 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination|||participants|||Number
2682313|NCT01385566|Primary|Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)|The VRC actively prompts for local injection-site AEs of redness, swelling, and pain/tenderness and for the size of local injection-site reactions of redness and swelling that occur within 5 days of vaccination. The presence of varicella/varicella-like rash and herpes zoster/herpes zoster-like rash is also captured on the VRC. Participants receiving an injection in both limbs will be instructed to complete injection-site reaction information for each limb. All injection-site AEs were reported for the limb in which they occurred: V211 vaccine or placebo.|Up to 5 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination|||Participants|||Number
2682314|NCT01385566|Primary|Number of Participants Reporting a Serious Adverse Experience|An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention|Within 5 days after the blood draw at approximately 20 months following vaccine administration|The population analyzed was all randomized participants who received study vaccination and had a Month 20 visit and follow-up|||Participants|||Number
2682315|NCT01385566|Primary|Number of Participants Reporting a Serious Adverse Experience (SAE)|An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention.|Up to 42 days following vaccine administration|The population analyzed was all randomized participants who received study vaccination|||participants|||Number
2682326|NCT01385306|Secondary|Number of Participants With Requirement for Concomitant Medications|Requirement for concomitant medications. Medications administered in the emergency department pre and post stimulation|Duration of stay in emergency room, up to approximately 6 hours|Safety population|||Participants|||Count of Participants
2684386|NCT01368497|Secondary|Proportion of Participants With HBeAg Seroconversion||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
2682317|NCT01385566|Primary|Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies|VZV antibody titers were measured by glycoprotein enzyme-linked immunosorbent assay at baseline and at 6 weeks after vaccine administration. The geometric mean fold change represents the 6-week value / the baseline value.|Baseline and 6 weeks following vaccine administration|The population analyzed included participants who received vaccination and did not have any protocol deviations that may have interfered with the immune response.|||Geometric mean fold change||90% Confidence Interval|Geometric Mean
2682318|NCT01385371|Secondary|Average Paediatric Standardised Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score Over the Peak GPS (Participants 6 to <12 Years of Age)|For PRQLQ, participants assessed a total of 19 items within 5 domains: Nose Symptoms, Eye Symptoms, Practical Problems, Activity Limitation and Other Symptoms, each on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0 to 6 [mean of all domain scores]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis.|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants <12 years of age who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.entry.|||score on a scale||Full Range|Median
2682319|NCT01385371|Secondary|Average Rhinoconjunctivitis DMS Over the Peak GPS|For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.|||score on a scale||Standard Error|Mean
2682320|NCT01385371|Secondary|Average Rhinoconjunctivitis DSS Over the Peak GPS|For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.|||score on a scale||Full Range|Median
2682321|NCT01385371|Secondary|Average Rhinoconjunctivitis DMS Over the Entire GPS|For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis.|Entire GPS (expected average duration of 5 to 6 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.|||score on a scale||Standard Error|Mean
2682322|NCT01385371|Secondary|Average Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities for Participants ≥12 Years of Age (RQLQ12+) Over the Peak GPS|The RQLQ12+ consists of 7 domains: Activities, Sleep, Non-Nose/Eye Symptoms, Practical Problems, Nasal Symptoms, Eye Symptoms, Emotional. Participants reflect on their experience over the previous 7 days and assess 28 items on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0-6 [mean of all domain scores]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis.|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants ≥12 years of age who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.|||score on a scale||Full Range|Median
2682323|NCT01385371|Secondary|Average Total Combined Rhinoconjunctivitis DSS and Rhinoconjunctivitis DMS Over the Peak GPS|"The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications.~For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.~For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis."|Peak GPS (expected average duration of 2 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.|||score on a scale||Full Range|Median
2682324|NCT01385371|Secondary|Average Rhinoconjunctivitis DSS Over the Entire GPS|For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.|Entire GPS (expected average duration of 5 to 6 weeks)|The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.|||score on a scale||Full Range|Median
2682325|NCT01385371|Primary|Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS)|"The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications.~For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms.~For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis."|Entire GPS (expected average duration of 5 to 6 weeks)|The Full Analysis Set (FAS) population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.|||score on a scale||Full Range|Median
2682328|NCT01385306|Secondary|Improvement in Dyspnea Score of at Least 1.5 Points From Baseline to 30 Minutes|Improvement in dyspnea was defined as at least 1.5 point decrease on a 10 point Visual Analogue Scale (VAS) compared with baseline (pre-first stimulation). Where 0 = no dyspnea and 10 = very severe dyspnea. The 30 minute measure was taken immediately after the second stimulation.|30 minutes|Safety population|||units on a scale||Full Range|Mean
2682329|NCT01385306|Secondary|Number of Participants With a Change in FEV1 (Forced Expiratory Volume at 1 Second) of 12% or More From Baseline to 30 Minutes|"Improvement in FEV1 was defined as an increase of at least 12% compared with baseline (pre-first stimulation). The 30 minute measure was taken immediately after the second stimulation.~(FEV1 measured as a percentage of normal, where greater that 80% is normal and less than 40% is severe degree of obstruction.)"|30 minutes|Safety population|||Participants|||Count of Participants
2682330|NCT01385306|Primary|Number of Participants With Adverse Events|Subjects were assessed for adverse events for the duration of procedure. Subjects were also seen at 7 days and had a phone call at 30 days from the date of the stimulation procedure.|30 days|Safety population|||Participants|||Count of Participants
2682331|NCT01385293|Secondary|Time to New Metastatic Disease From the Baseline Visit|Time in days from the start of study treatment to time of new metastatic disease. Time to new metastatic disease is, defined from the date of first study agent administration to the onset of a new evaluable site of disease as per PCWG2 and RECIST 1.1 guidelines, excluding the primary site and all sites documented at baseline will be assessed. Only those patients that experienced a new lesion per this definition are included.|5 years|Only those patients that experienced a new lesion per this definition are included.|||days||Full Range|Median
2682332|NCT01385293|Secondary|Change in Circulating Tumor Cell (CTC) Levels From Baseline|The number of patients with a baseline CTC level of at least 5 who achieved a CTC level of less than 5 during the study.|2 years|13 patients had measured CTC levels above 5 at baseline|||participants|||Number
2682333|NCT01385293|Secondary|Overall Survival of Participants.|Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.|5 years|Intent to treat|||months||95% Confidence Interval|Median
2682334|NCT01385293|Secondary|Prostate Specific Antigen (PSA) Response|The number of patients with a 30% and 50% decrease in PSA from baseline.|2 years|Intent to treat|||participants|||Number
2682335|NCT01385293|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|Number of patients experiencing grade 3-5 adverse events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0|Up to 28 days post last study drug dose. This is the follow-up safety visit.|Intent to treat|||participants|||Number
2682336|NCT01385293|Secondary|Radiologic Response|The number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. Response and progression is evaluated using a combination of the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) and the guidelines for prostate cancer endpoints developed by the Prostate Cancer Clinical Trials Working Group (PCWG2). Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|2 years|Intent to treat|||participants|||Number
2682337|NCT01385293|Primary|Progression Free Survival (PFS) Prostate Cancer Working Group 2 (PCWG2) Criteria or Based on the Onset of a Skeletal Related Event.|"Time in months from the start of study treatment to the date of first progression or death due to any cause. Progression was determined either radiographically using a composite of the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Working Group 2 (PCWG2) criteria or clinically as judged from a skeletal-related event, need for change in therapy, or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.~Response and progression are evaluated using a combination of Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and guidelines for prostate cancer endpoints developed by the Prostate Cancer Clinical Trials Working Group (PCWG2). Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|5 years|Intent to treat|||months||95% Confidence Interval|Median
2682338|NCT01385280|Secondary|Median Time From Entry on Study to Progression of Disease|In weeks|Up to 1.5 years|Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.||||||
2682339|NCT01385280|Secondary|Change in Circulating Tumor Cells (CTC) IGF1R Expression With Treatment||At baseline and on days 8, 90, and 180|Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.||||||
2682340|NCT01385280|Secondary|Change in Circulating Tumor Cells (CTC) ER Expression With Treatment||At baseline and on days 8, 90, and 180|Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.||||||
2682341|NCT01385280|Secondary|Patients With Change in Circulating Tumor Cells (CTC) Expression of M-30 With Treatment||At baseline and on days 8, 90, and 180|Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.||||||
2682342|NCT01385280|Secondary|Patients With Change in Number of Circulating Tumor Cells (CTC) With Treatment||At baseline and on days 8, 90, and 180|Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.||||||
2682343|NCT01385280|Secondary|Patients With Change in Serum M-30 (a Marker of Mitochondrial Apoptosis) With Treatment||At baseline and on days, 8, 30, 60, and 90|Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.||||||
2682344|NCT01385280|Primary|Number of Participants With Grade 4 Toxicity|Such as deep vein thrombosis requiring hospitalization or pulmonary embolism|By day 90|Study was terminated - the PI is deceased. Attempts were made to locate the data but it seems that data were never fully collected/analyzed.||||||
2683579|NCT01374906|Secondary|Percentage Change in Mean Urinary Free Cortisol (mUFC) From Baseline|Percentage change in mUFC (nmol/24h) from baseline by randomized groups.|M7, M12, M24, M36|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage change||Standard Deviation|Mean
2682345|NCT01385202|Secondary|Rate of Acute Success|Acute success is defined as confirmation of entrance block in all Pulmonary veins (PV).|End of procedure|The analysis population for this endpoint includes two groups; a): Calibration Roll-in subjects who were prospectively identified prior to the study procedure and b) the Effectiveness Cohort. Both groups underwent an AF ablation procedure with the study catheter.|||percentage of participants|||Number
2682346|NCT01385202|Primary|Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events.|Primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient Ischemic Attack (TIA), Stroke / Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac Tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular Access Complications, Pulmonary edema, Hospitalization (initial and prolonged), and Heart block.|7 days of the AF ablation procedure|Safety cohort includes all enrolled subjects who had the study catheter inserted.|||Percentage of patients with primary AE||95% Confidence Interval|Number
2682347|NCT01385202|Primary|The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up|The primary effectiveness endpoint for this study will be freedom from documented symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) episodes through 12-month follow-up (includes a three month blanking period).|12-months|Primary Effectiveness Cohort includes those enrolled who met the inclusion/exclusion criteria and had undergone insertion of the study catheter and Atrial Fibrillation (AF) ablation procedure, excluding those with radiofrequency energy not delivered, with calibration roll-in, and with only non-study arrhythmia.|||percentage of participants||95% Confidence Interval|Number
2682348|NCT01385189|Secondary|IgG Antibody Response to Na-GST-1|Dose and formulation of Na-GST-1 that generates the highest IgG antibody response at Day 126, as determined by an indirect enzyme-linked immunosorbent assay (ELISA)|126 days post dose 1||||Arbitrary Units||Standard Deviation|Mean
2682349|NCT01385189|Primary|Immediate Vaccine Related Adverse Events|Frequency of vaccine-related AEs, graded by severity, for each dose and formulation of Na-GST-1|2 hours post vaccination||||Participants|||Count of Participants
2682350|NCT01385176|Secondary|LVESV, Left Ventricular End Systolic Volume|Measurements of LVESV, left ventricular end systolic volume at Baseline and 6 months after Baseline in the Control Arm and in the Therapy Arm|At Baseline and at 6-months after Baseline|Measurements of LVESV, left ventricular end systolic volume at Baseline and at 6-months after Baseline. Participants without paired endpoint data did not contribute to the analysis.|||ml||Standard Deviation|Mean
2682351|NCT01385176|Secondary|Exercise Capacity, Peak VO2|Assessment of functional capacity (e.g., peak VO2) as measures related to patient heart failure status.|Measurements at Baseline and at 6-months after Baseline|Participants without paired endpoint data did not contribute to the analysis.|||ml/kg/min||Standard Deviation|Mean
2682352|NCT01385176|Secondary|LVEF, Left Ventricular Ejection Fraction|LVEF, left ventricular ejection fraction.|LVEF at Baseline and at 6-months after Baseline|LVEF echocardiographic measurements were made at Baseline and at 6 months after Baseline. Participants without paired endpoint data did not contribute to the analysis.|||% of blood ejected from ventricle||Standard Deviation|Mean
2682353|NCT01385176|Primary|Percentage of Surviving Participants|As pre-specified in the study protocol, the All-cause Survival endpoint combined both groups into one analysis population. Subjects contributed data according to the follow-up period during they received VNS therapy (Implant through 18 months for Therapy subjects, 6 through 18 months for Control subjects). Control patients who exited the study in the first 6 months, or who did not have a 6 month visit, were excluded.|18-months|Therapy group received VNS from implant to 18 months. Control group received VNS from 6 months to 18 months. These follow-up periods contributed to the endpoint analysis. Both groups were combined for mortality endpoint analysis. Control patients who exited the study in the first 6 months, or who did not have a 6 month visit, were excluded.|||Percentage of participants surving||90% Confidence Interval|Number
2682354|NCT01385176|Primary|Change in Left Ventricular End-systolic Dimension (LVESD)|"Change in the Left ventricular end-systolic dimension (LVESD) between Baseline and the value at the end of the randomization phase (6 months after Baseline) i.e. 6 months after vagus nerve stimulation in the THERAPY Arm. No Vagus nerve stimulation during that time window in the CONTROL Arm.~The sign (- ) indicates a reduction in the LVESD. Minus means a reduction in LVESD.~The change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline)."|LVESD at Baseline and at 6-months post Baseline|The sign (- ) indicates a reduction in the LVESD. Participants without paired endpoint data did not contribute to the analysis.|||cm||Standard Deviation|Mean
2682355|NCT01385137|Secondary|Week 12 Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Score|"FACT-ES measures physical, social and family, emotional, and functional well-being and endocrine symptoms. The FACT scaleshave five response levels (not at all to very much), where higher scores reflect better well-being and fewer symptoms. This scale provided a measure of the broader impact of join pain and stiffness symptoms. Score range is 0 to 220."|12 weeks post-registration||||FACT-ES score||95% Confidence Interval|Mean
2682356|NCT01385137|Secondary|Week 12 Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) Score|Linear regression model-adjusted week 12 mean score by treatment group. Higher scores represent higher symptom burden. Range is 0 to 100.|12 weeks post-registration||||M-SACRAH score||95% Confidence Interval|Mean
2682357|NCT01385137|Secondary|Week 12 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score|Linear regression model-adjusted week 12 mean score by treatment group The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores indicate higher symptom burden.|12 weeks post-registration||||WOMAC score||95% Confidence Interval|Mean
2682358|NCT01385137|Secondary|Number of Patients With Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 25 weeks|All participants receiving at least some protocol treatment|||Participants|||Number
2684233|NCT01369706|Primary|Electromagnetic Interference|inhibition of the pacemaker, loss of capture, inappropriate mode switch, ventricular oversensing, power-on-reset, device reprogramming or loss of function|time during exposure to hand-held metal detector (2x 30 sec)|Electromagnetic interference|||participants|||Number
2682359|NCT01385137|Primary|Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score|"Linear regression model-adjusted week 12 mean score by treatment group.~Purpose: To assess the severity of pain Population: Patients with pain from chronic diseases or conditions such as cancer, osteoarthritis and low back pain, or with pain from acute conditions such as postoperative pain Responsiveness: Responds to both behavioral and pharmacological pain interventions Method: Self-report or interview Scoring: Higher scores indicate more pain Range: 0-10"|12 weeks post-registration||||BPI score||95% Confidence Interval|Mean
2682360|NCT01385098|Secondary|Serum 25-hydroxyvitamin D Levels at Baseline and 12 Weeks of Daily Vit D Supplementation Post Roux-en Y OR Sleeve Gastrectomy|We anticipate that vitamin D supplementation of Roux-en Y bariatric surgery patients will be less effective in improving or maintaining vitamin D status.|Baseline and 12 weeks||||ng/mL||Standard Deviation|Mean
2682361|NCT01385098|Primary|Vitamin D Concentrations, Pre Operative and Post Bariatric Surgery Following 12 Weeks of Vitamin D Supplementation|Serum 25(OH)D ng/ml levels at baseline and 12 weeks following bariatric surgery|baseline and 12 weeks||||ng/mL||Standard Deviation|Mean
2682362|NCT01385033|Primary|Amyloid Plaque Burden Threshold Determined by the Trimmed HE Sample Mean and SD Brain Cortical [18F]MK-3328 SUVR|Using PET brain images acquired after dosing, ROIs are drawn in identified brain areas. ROIs are projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue TACs. SUVR is calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum. Cortical SUVR is determined, which is a mean SUVR derived from SUVR from multiple brain regions. The 1st and 2nd quartiles of the cortical SUVR distribution, Q1 and Q2, are computed for HE data; values with SUVR ≥(Q2-Q1)*3 are removed before calculation of HE mean (trimmed) and SD (trimmed). This step is performed to remove HE participants with positive plaque burden. Using HE data, the threshold for classification of plaque burden as positive/negative will be calculated as mean (trimmed) + k*SD (trimmed). Value of k will be chosen to fine tune sensitivity/specificity, with specificity of at least 0.9 in the sub-group remaining after trimming of data.|60-90 minutes post dose|The study was terminated early before completion of Part I. Given the low number of enrolled AD participants (6 of up to 15 planned in Part I), the interim analysis for futility in Part I was not conducted and the determination of an amyloid plaque burden threshold using PET imaging data obtained after [18F]MK-3328 administration was not performed.||||||
2682363|NCT01385033|Primary|Brain Cortical [18F]MK-3328 SUVR in AD Participants and HE Participants|Using PET brain images acquired after dosing, ROIs are drawn in identified brain areas. The ROIs are projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue TACs. SUVR is calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum. Cortical SUVR is reported, which is a mean SUVR derived from SUVR from multiple brain regions (frontal cortex, parietal cortex, anterior cingulated gyrus, posterior cingulated gyrus, temporal cortex, lateral temporal cortex and occipital cortices). A trimming procedure will be applied to remove the sub-population of HE participants who have positive amyloid plaque burden. The 1st and 2nd quartiles of the cortical SUVR distribution, Q1 and Q2, are computed for HE data; values with SUVR ≥(Q2-Q1)*3 are removed before calculation of HE mean (trimmed) and standard deviation (SD)(trimmed).|60-90 minutes post dose|The study was terminated early before completion of Part I. Given the low number of enrolled AD participants (6 of up to 15 planned in Part I), the interim analysis for futility in Part I was not conducted and the determination of brain cortical [18F]MK-3328 SUVR values in AD and HE participants was not performed.||||||
2682364|NCT01385033|Primary|Area Under the Receiver Operating Curve (AUC of ROC) for Distinguishing Between AD and HE Participants Based on Brain Cortical [18F]MK-3328 Standard Uptake Value Ratio (SUVR)|Using PET brain images acquired after dosing, regions of interest (ROIs) are drawn in identified brain areas. The ROIs are projected onto all frames of the dynamic PET scans in order to generate [18F]MK-3328 tissue time-activity curves (TACs). SUVR is calculated as the ratio of the average [18F]MK-3328 uptake over 60-90 minutes post dose in the target brain region and the cerebellum. Cortical SUVR is determined, which is a mean SUVR derived from SUVR from multiple brain regions (frontal cortex, parietal cortex, anterior cingulate gyrus, posterior cingulate gyrus, temporal cortex, lateral temporal cortex and occipital cortices). The receiver operating curve (ROC) for determining whether a participant is in HE or AD group by using cortical SUVR values is determined. The ROC is a plot of sensitivity on the y-axis versus 1-specificity (false positive rate) on the x-axis for the range of cortical SUVR threshold values. The AUC of ROC is determined.|60-90 minutes post dose|The study was terminated early before completion of Part I. Given the low number of enrolled AD participants (6 of up to 15 planned in Part I), the interim analysis for futility in Part I was not conducted and the potential of [18F]MK-3328 to distinguish between AD and HE participants was not assessed.||||||
2682365|NCT01384877|Secondary|Quality of Life Question: Over the Past 3 Days, Have Any Practical Matters Resulting From Your Illness, Either Financial or Personal, Been Addressed?|Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores|At most 6 weeks (duration of study)|Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study|||score on a scale||Standard Deviation|Mean
2682366|NCT01384877|Secondary|Quality of Life Question: Over the Past 3 Days, How Much Time do You Feel Has Been Wasted on Appointments Relating to Your Healthcare e.g. Waiting Around for Transport or Repeating Tests?|Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores|At most 6 weeks (duration of study)|Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study|||score on a scale||Standard Deviation|Mean
2682403|NCT01384591|Secondary|Global Fatigue Score as Measured by Brief Fatigue Inventory at Baseline|"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Score ranges (0 to 10) with higher score indicating a worse outcome."|Baseline||||units on a scale||Standard Deviation|Mean
2682367|NCT01384877|Secondary|Quality of Life Question: Over the Past 3 Days, Have You Felt Good About Yourself as a Person?|Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores|At most 6 weeks (duration of study)|Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study|||score on a scale||Standard Deviation|Mean
2682368|NCT01384877|Secondary|Quality of Life Question: Over the Past 3 Days, Have You Been Feeling Depressed?|Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores|At most 6 weeks (duration of study)|Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study|||score on a scale||Standard Deviation|Mean
2682369|NCT01384877|Secondary|Quality of Life Question: Over the Past 3 Days, Have You Been Able to Share How You Are Feeling With Your Family or Friends?|Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores|At most 6 weeks (duration of study)|Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study|||score on a scale||Standard Deviation|Mean
2682370|NCT01384877|Secondary|Quality of Life Question: Over the Past 3 Days, Have Any of Your Family or Friends Been Anxious or Worried About You?|Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores|At most 6 weeks (duration of study)|Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study|||score on a scale||Standard Deviation|Mean
2682371|NCT01384877|Secondary|Quality of Life Question: Over the Past 3 Days, Have You Been Feeling Anxious or Worried About Your Illness or Treatment?|Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores|At most 6 weeks (duration of study)|Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study|||score on a scale||Standard Deviation|Mean
2682372|NCT01384877|Secondary|Quality of Life Question: Over the Past 3 Days, Have Other Symptoms e.g. Feeling Sick, Having a Cough or Constipation Been Affecting How You Feel?|Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores|At most 6 weeks (duration of study)|Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study|||score on a scale||Standard Deviation|Mean
2682373|NCT01384877|Secondary|Quality of Life Question: Over the Past 3 Days, Have You Been Affected by Pain?|Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores|At most 6 weeks (duration of study)|Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study|||score on a scale||Standard Deviation|Mean
2682374|NCT01384877|Primary|Number of Participants With Reduction in Worst Pain Intensity or Reduction in 24hr Opioid Dose of at Least 30% Without Worsening of Pain Scores|"The primary outcomes measure is a binary variable indicating whether lidocaine caused a reduction in cancer pain within 48 hours of infusion and lasting a minimum of 7 days. Lidocaine will be considered to have caused reduction in cancer pain if the subject had either one of the following episodes and lasting a minimum of 7 days:~A 2-point reduction in severity of pain as assessed by the worst pain score in the last 24 hours (question 3) of the Brief Pain Inventory - Short Form (BPI), compared to the BPI pain score at baseline.~Or:~≥30% reduction in 24-hour opioid dose."|7 days|Participants were included in analysis if they completed both treatment periods and all the data was collected for both treatment periods|||Participants|||Count of Participants
2682375|NCT01384760|Secondary|Epworth Sleepiness Score (ESS)|The Epworth Sleepiness Scale (ESS) is a questionnaire for assessing daytime sleepiness. It was first described in 1991 as a simple, self-administered questionnaire. The questionnaire is based on eight common situations in life. Subjects are asked to rate on a scale of 0-3 about how likely they would fall asleep or doze off in these circumstances. This gives a total score of 0 to 24 in each subject.The total score ranges from 0 to 24, with higher scores indicating higher sleepiness.|1 year||||units on a scale||Standard Deviation|Mean
2682376|NCT01384760|Primary|Apnea-hypopnea Index (AHI) at One Year|AHI is a count of the number of upper airway obstruction per hour of sleep. The index will be derived from the overnight home sleep study.|1 year||||events per hour||Standard Deviation|Mean
2682402|NCT01384591|Secondary|Global Fatigue Score as Measured by Brief Fatigue Inventory After Study Invention|"The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with 0 being no fatigue and 10 being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. Score range 0 to 10, with a higher score indicating a worse outcome."|Post dose three of the intervention, average of 17 hours post dose one intervention||||units on a scale||Standard Deviation|Mean
2682377|NCT01384734|Secondary|Change From Baseline in IC50 Fold Change Among Participants With VF at Week 96|Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed.|Baseline and up to Week 96|ITT-E Resistance Tested through Week 96 Population|||IC50 Fold Change||Standard Deviation|Mean
2682378|NCT01384734|Secondary|Change From Baseline in IC50 Fold Change Among Participants With VF at Week 48|Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL. The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed.|Baseline and up to Week 48|ITT-E Resistance Tested through Week 48 Population|||IC50 Fold Change||Standard Deviation|Mean
2682379|NCT01384734|Secondary|Maximum Change From Baseline in Inhibitory Concentration at 50% (IC50) Fold Change Among Participants With VF at Week 24|Virologic failure is defined clinically as confirmed plasma HIV-1 RNA >= 50 copies/mL at Week 24 or later or virologic rebound defined as confirmed HIV-1 RNA >=50 copies/mL at any time after prior confirmed suppression to <50 copies/mL OR confirmed >1 log10 copies/mL increase in HIV-1 RNA at any time above nadir level where nadir was >= 50 copies/mL . The phenotypic resistance to a drug is defined as a fold change (i.e, ratio of the IC50 of the clinical isolate to the IC50 of the reference strain) greater than the cut-off for reduced susceptibility. Maximum change from Baseline in Temsavir IC50 fold change based on all on-treatment values has been presented. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed.|Baseline and up to Week 24|ITT-E Resistance Tested through Week 24 Population|||IC50 Fold Change||Standard Deviation|Mean
2682380|NCT01384734|Secondary|Number of Participants With Newly-emergent Genotypic Substitutions at Week 96|Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 96 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 96 Snapshot analysis window. The criteria for resistance tested was participants with virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL.|Up to Week 96|ITT-E Resistance Tested through Week 96 Population|||Participants|||Count of Participants
2682381|NCT01384734|Secondary|Number of Participants With Newly-emergent Genotypic Substitutions at Week 48|Participants who administered ARV with VF were assessed. Genotypic substitution included assessment of RT substitution, PI substitution and Integrase RAL substitution as per IAS-USA list. ITT-E Resistance Tested through Week 48 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 48 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL.|Up to Week 48|ITT-E Resistance Tested through Week 48 Population|||Participants|||Count of Participants
2682382|NCT01384734|Secondary|Number of Participants With Newly-emergent Genotypic Substitutions at Week 24|Participants who administered antiretroviral (ARV) with virologic failure (VF) were assessed. Genotypic substitution included assessment of Reverse Transcriptase (RT) substitution, Protease Inhibitor (PI) substitution and Integrase RAL substitution as per International Acquired Immune Deficiency Syndrome (AIDS) Society-USA (IAS-USA) list. ITT-E Resistance Tested through Week 24 population included participants who met the criteria for Resistance testing, and the confirmatory value or value at discontinuation occurred at or before the end of the Week 24 Snapshot analysis window. The criteria for resistance tested was participant who had virologic failure or met the following criteria a) Participants who achieved viral suppression (plasma HIV-1 RNA < 50 c/mL) and have confirmed plasma HIV-1 RNA >= 400 c/mL at any time during the study. b) Participants who were discontinued before achieving viral suppression (plasma HIV-1 RNA < 50 c/mL) after Week 8 with last plasma HIV-1 RNA >=400 c/mL.|Up to Week 24|ITT-E Resistance Tested through Week 24 Population|||Participants|||Count of Participants
2682383|NCT01384734|Secondary|Change From Baseline in CD4+ T-cell Count|Blood was collected and CD4+ cell count assessment by flow cytometery was carried out at Baseline (Day 1), Weeks 24, 48 and 96 to evaluate the immunological activity of multiple doses of BMS-663068/GSK3684934. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and those values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and Weeks 24, 48 and 96|ITT-E Population|||Cells per cubic millimeter||Standard Deviation|Mean
2682384|NCT01384734|Secondary|Number of Participants With SAE and Discontinuation Due to AEs During Primary Study|Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety Population comprised of participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week X (where X = 48 or 96) included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 48 and 96 visit snapshot window.|Weeks 48 and 96|Safety Population|||Participants|||Count of Participants
2682385|NCT01384734|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Primary Study|Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage CI. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest.|Weeks 48 and 96|ITT-E Population|||Percentage of Participants||95% Confidence Interval|Number
2682386|NCT01384734|Secondary|Change From Monotherapy Baseline in CD4+ and CD8+ T-cell Proportion During Monotherapy|Blood was collected and CD4+ and CD8+ proportion assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed.|Baseline and Day 8|ITT-E Monotherapy Population|||cells per cubic millimeter||Standard Deviation|Mean
2682387|NCT01384734|Secondary|Change From Monotherapy Baseline in Cluster of Differentiation (CD)4+ and CD8+ T-cell Counts During Monotherapy|Blood was collected and CD4+ and CD8+ cell count assessment was done by flow cytometery and was carried out at Baseline (Day 1) to evaluate the immunological activity of multiple doses of FTR. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment and the values are absolute values. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants with data available at the specified time points were analyzed.|Baseline and Day 8|ITT-E Monotherapy Population|||cells per cubic millimeter||Standard Deviation|Mean
2682388|NCT01384734|Secondary|Number of Participants With SAE and Discontinuation Due to AEs During Monotherapy Period|Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment.|Up to Day 8 of the monotherapy period|ITT-E Monotherapy Population|||Participants|||Count of Participants
2682389|NCT01384734|Secondary|Percentage of Participants With Plasma HIV-1 RNA < 50 c/mL at Day 8 of the Monotherapy Period|Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Baseline of combination therapy was assessed to evaluate the antiviral activity of four doses of FTR. Baseline of combination therapy was the Day 1 of the combination therapy. Virologic success or failure was determined using the non-missing viral load value at Baseline of combination therapy. The assessment closest to the window target Study Day was used for the analysis. Only those participants with data available at the specified time points were analyzed.|Up to Day 8 of the monotherapy period|ITT-E Monotherapy Population|||Percentage of Participants||95% Confidence Interval|Number
2682390|NCT01384734|Secondary|Maximum Decrease From Monotherapy Baseline in log10 Plasma HIV-1 RNA|Maximum decrease from monotherapy Baseline in log10 plasma HIV-1 RNA during monotherapy to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. The data for monotherapy nadir has been presented where nadir represents the maximum decrease from Baseline.|Baseline and up to Day 8 of the monotherapy period|ITT-E Monotherapy Population|||log10 c/mL||Standard Deviation|Mean
2682391|NCT01384734|Secondary|Change From Monotherapy Baseline in log10 HIV RNA of the Monotherapy Period|Change from monotherapy Baseline in log10 HIV RNA to assess the antiviral activity of temsavir following administration of selected doses of FTR administered orally to HIV-1-infected participants for 7 days. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as value at indicated time point minus Baseline value. ITT-E Monotherapy Population comprised of participants that were randomized and participated in the monotherapy sub-study and received at least one dose of FTR Monotherapy. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|Baseline and up to Day 8 of the monotherapy period|ITT-E Monotherapy Population|||log10 c/mL||Standard Deviation|Mean
2682392|NCT01384734|Primary|Number of Participants With Serious Adverse Events (SAE) and Discontinuation Due to AEs up to Week 24|Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or suspected transmission of an infectious agent via the study drug were categorized as SAE. AEs leading to discontinuation of study therapy were also reported as safety assessment. Safety population included all participants who received at least one dose of study treatment. Summaries of SAEs and AEs leading to discontinuation or withdrawal through Week 24 included AEs with onset on or after the start of study treatment (i.e. study date of first study treatment intake) up to and including the end of the Week 24 visit snapshot window.|Up to Week 24|Safety Population|||Participants|||Count of Participants
2683109|NCT01379521|Secondary|Percentage of Participants With a Decrease in the Sum of the of Longest Diameters (SLD) of Target Lesions From Baseline to 30 Months|Percentage of participants with a decrease in the sum of the of longest diameters (SLD) of target lesions from Baseline to 30 months|baseline, 30 months|Full Analysis Set (FAS) comprises all randomized patients.|||Percentage of participants|||Number
2682393|NCT01384734|Primary|Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) < 50 Copies Per Milliliter (c/mL) at Week 24|Percentage of participants with plasma HIV 1 RNA < 50 c/mL at Week 24 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to evaluate the antiviral activity. Treatment comparisons were not performed as this was an estimation study. Response rates were tabulated by treatment arm with exact Clopper-Pearson binomial 95 percentage confidence intervals (CI). Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the snapshot window of the visit of interest. Intent-To-Treat-Exposed (ITT-E) Population includes all randomized participants who received at least one dose of study treatment.|Week 24|ITT-E Population|||Percentage of Participants||95% Confidence Interval|Number
2682394|NCT01384591|Secondary|Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study Intervention|"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention."|Post dose three of the intervention, average of 17 hours post dose one intervention - Directly after handgrip fatigue test|Data for 1 subject was not recorded|||units on a scale||Standard Deviation|Mean
2682395|NCT01384591|Secondary|Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study Intervention|"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention."|Post dose three of the intervention, average of 17 hours post dose one intervention - Before handgrip fatigue test||||units on a scale||Standard Deviation|Mean
2682396|NCT01384591|Secondary|Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline.|"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention."|baseline - directly after handgrip fatigue test||||units on a scale||Standard Deviation|Mean
2682397|NCT01384591|Secondary|Perceptual Fatigue of Whole Body as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline.|"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention."|baseline - before handgrip fatigue test||||units on a scale||Standard Deviation|Mean
2682398|NCT01384591|Secondary|Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test After Study Intervention|"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention."|Post dose three of the intervention, average of 17 hours post dose one intervention - Directly after handgrip fatigue test|Data for 1 subject was not collected.|||units on a scale||Standard Deviation|Mean
2682399|NCT01384591|Secondary|Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test After Study Intervention|"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention."|Post dose three of the intervention, average of 17 hours post dose one intervention - Before handgrip fatigue test||||units on a scale||Standard Deviation|Mean
2682400|NCT01384591|Secondary|Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale After Handgrip Fatigue Test at Baseline.|"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention."|baseline - directly after handgrip fatigue test||||units on a scale||Standard Deviation|Mean
2682401|NCT01384591|Secondary|Perceptual Fatigue of Non-dominant Arm as Measured by Visual Analog Scale Before Handgrip Fatigue Test at Baseline.|"The Visual Analog Scale for Fatigue is an 11cm long line. The subject is asked to mark their level of fatigue (0cm being no fatigue and 11cm being extreme fatigue). This test was performed before and after the handgrip fatigue test, where the non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes.~Handgrip testing was performed at baseline (before any intervention) and post dose three of the intervention, average of 17 hours post dose one intervention."|baseline - before handgrip fatigue test||||units on a scale||Standard Deviation|Mean
2682838|NCT01380782|Other Pre-specified|Exploratory Objective #1: Progression-free Survival at 3- and 6-months for Participants With Recurrent Anaplastic Gliomas (AG)|To explore the efficacy of BIBF 1120 in bevacizumab-naïve and bevacizumab-treated participants with recurrent anaplastic gliomas (AG) survival was assessed at 6 months for Arm A and 3 months for Arm B.|Arm A - 6 months; Arm B - 3 months||||percentage of participants|||Number
2682404|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score After All Doses of Study Intervention|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Post dose three of the intervention, average of 17 hours post dose one intervention||||units on a scale||Standard Deviation|Mean
2682405|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Total Score at Baseline|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Baseline||||units on a scale||Standard Deviation|Mean
2682406|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue After All Doses of Study Intervention|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the vigor scale is 0 to 24, with the higher number meaning more vigor.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Post dose three of the intervention, average of 17 hours post dose one intervention||||units on a scale||Standard Deviation|Mean
2682407|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Vigor Fatigue at Baseline|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the vigor scale is 0 to 24, with the higher number meaning more vigor.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Baseline||||units on a scale||Standard Deviation|Mean
2682408|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue After All Doses of Study Intervention|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the mental fatigue scale is 24 to 0, with the higher number meaning more fatigue~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Post dose three of the intervention, average of 17 hours post dose one intervention||||units on a scale||Standard Deviation|Mean
2682409|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Mental Fatigue at Baseline|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the mental fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Baseline||||units on a scale||Standard Deviation|Mean
2682410|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue After All Doses of Study Intervention|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the emotional fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Post dose three of the intervention, average of 17 hours post dose one intervention||||units on a scale||Standard Deviation|Mean
2682411|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Emotional Fatigue at Baseline|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the emotional fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Baseline||||units on a scale||Standard Deviation|Mean
2684387|NCT01368497|Secondary|Proportion of Participants With HBeAg Seroconversion||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
2682412|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue After All Doses of Study Intervention|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the physical fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Post dose three of the intervention, average of 17 hours post dose one intervention||||units on a scale||Standard Deviation|Mean
2682413|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale Physical Fatigue at Baseline|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the physical fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Baseline||||units on a scale||Standard Deviation|Mean
2682414|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue After All Doses of Study Intervention|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the general fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Post dose three of the intervention, average of 17 hours post dose one intervention||||units on a scale||Standard Deviation|Mean
2682415|NCT01384591|Secondary|Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory - Subscale General Fatigue at Baseline|"Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue.~There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score.~The range of the general fatigue scale is 24 to 0, with the higher number meaning more fatigue.~The range of the total score is -24 to 96, with the higher the number meaning more fatigue."|Baseline||||units on a scale||Standard Deviation|Mean
2682416|NCT01384591|Secondary|Handgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention|Handgrip fatigue of non-dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data reported as % of Maximal Voluntary Contraction (MVC) after fatigue test.|Post dose three of the intervention, average of 17 hours post dose one intervention|Data from 2 subjects was not recorded.|||% of Maximal Voluntary Contraction||Standard Deviation|Mean
2682417|NCT01384591|Secondary|Handgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry After All Doses of Study Intervention|Handgrip fatigue of dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data reported as % of Maximal Voluntary Contraction (MVC) after fatigue test.|Post dose three of the intervention, average of 17 hours post dose one intervention|Data for 2 subjects not recorded.|||% of Maximal Voluntary Contraction||Standard Deviation|Mean
2682418|NCT01384591|Secondary|Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study Intervention|Handgrip Strength of non-dominant hand is measured by handgrip dynamometry at 100% perceived effort with subjects performing one set of three contractions.|Post dose three of the intervention, average of 17 hours post dose one intervention||||kilograms||Standard Deviation|Mean
2682419|NCT01384591|Secondary|Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Perceived Effort After All Doses of Study Intervention|Handgrip Strength of dominant hand is measured by handgrip dynamometry at 100% perceived effort with subjects performing one set of three contractions.|Post dose three of the intervention, average of 17 hours post dose one intervention||||kilograms||Standard Deviation|Mean
2682420|NCT01384591|Secondary|Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study Intervention|Handgrip Strength of non-dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.|Post dose three of the intervention, average of 17 hours post dose one intervention||||kilograms||Standard Deviation|Mean
2682421|NCT01384591|Secondary|Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort After All Doses of Study Intervention|Handgrip Strength of dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.|Post dose three of the intervention, average of 17 hours post dose one intervention||||kilograms||Standard Deviation|Mean
2682422|NCT01384591|Secondary|Handgrip Fatigue of Non-dominant Hand as Measured by Handgrip Dynamometry at Baseline|Handgrip fatigue of non-dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data is reported as % of Maximal Voluntary Contraction (MVC) after fatigue test.|baseline|Data for 2 subjects was not recorded.|||% of Maximal Voluntary Contraction||Standard Deviation|Mean
2684388|NCT01368497|Secondary|Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
2682423|NCT01384591|Secondary|Handgrip Fatigue of Dominant Hand as Measured by Handgrip Dynamometry at Baseline|Handgrip fatigue of dominant hand as measured by handgrip dynamometry fatigue test. The non-dominant hand hold a continuous contraction at 20% of the subjects maximal voluntary contraction for 5 minutes. Data is reported as % of Maximal Voluntary Contraction after fatigue test.|baseline|Data for 2 subjects wasn't recorded.|||% of Maximal Voluntary Contraction||Standard Deviation|Mean
2682424|NCT01384591|Secondary|Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline|Handgrip Strength of non-dominant hand is measured by handgrip dynamometry at 100% effort with subjects performing one set of three contractions.|baseline||||kilograms||Standard Deviation|Mean
2682425|NCT01384591|Secondary|Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 100% Effort at Baseline|Handgrip Strength of dominant hand is measured by handgrip dynamometry at 100% effort with subjects performing one set of three contractions.|baseline||||kilograms||Standard Deviation|Mean
2682426|NCT01384591|Secondary|Handgrip Strength of Non-dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline|Handgrip Strength of non-dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.|baseline||||kilograms||Standard Deviation|Mean
2682427|NCT01384591|Secondary|Handgrip Strength of Dominant Hand as Measured by Handgrip Dynamometry at 50% Perceived Effort at Baseline|Handgrip Strength of dominant hand is measured by handgrip dynamometry at 50% perceived effort with subjects performing one set of three contractions.|baseline||||kilograms||Standard Deviation|Mean
2682428|NCT01384591|Primary|Leg Blood Flow as Measured by Doppler Ultrasound|Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.|2 hours post dose three of the intervention and a meal, average of 19 hours post dose one of the intervention||||ml/minute||Standard Deviation|Mean
2682429|NCT01384591|Primary|Leg Blood Flow as Measured by Doppler Ultrasound|Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.|1 hour post dose three of the intervention and a meal, average of 18 hours post dose one of the intervention||||ml/minute||Standard Deviation|Mean
2682430|NCT01384591|Primary|Leg Blood Flow as Measured by Doppler Ultrasound|Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.|Post dose three of the intervention and a meal, average of 17 hours post dose one of the intervention||||ml/minute||Standard Deviation|Mean
2682431|NCT01384591|Primary|Leg Blood Flow as Measured by Doppler Ultrasound|Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.|2 hours post dose two of the intervention, average of 14 hours post dose one of the intervention||||ml/minute||Standard Deviation|Mean
2682432|NCT01384591|Primary|Leg Blood Flow as Measured by Doppler Ultrasound|Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.|1 hour post dose two of the intervention, average of 13 hours post dose 1 of the intervention|Missed blood flow measurement on one placebo participant at this time point.|||ml/minute||Standard Deviation|Mean
2682433|NCT01384591|Primary|Leg Blood Flow as Measured by Doppler Ultrasound|Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.|12 hours post dose one of the intervention||||ml/minute||Standard Deviation|Mean
2682434|NCT01384591|Primary|Leg Blood Flow as Measured by Doppler Ultrasound|Femoral Doppler Blood Flow was evaluated via Doppler ultrasound. For the two-dimensional (2-D) and Doppler ultrasound measurements, an ultrasound system (HDI-5000; Philips Medical Systems, Bothell, WA) with a linear array transducer (L7-4) was used with a transmit frequency of 12MHz. 2-D imaging of the common femoral artery will be performed in the long axis. Images will be triggered to the R wave of the cardiac cycle, and the femoral artery diameter will be measured using online video calipers. A pulsed-wave Doppler sample blood volume will be placed at the same location in the center of the artery, and the mean blood velocity will be measured using online angle correction and analysis software. Femoral artery mean blood flow will be calculated from 2-D and Doppler ultrasound data using the equation: Q = vπ ∙ (d/2)2, where Q is femoral blood flow, v is mean femoral artery blood flow velocity, and d is femoral artery diameter.|Baseline||||ml/minute||Standard Deviation|Mean
2682435|NCT01384539|Secondary|Compare the Effect of Calcitriol and Cholecalciferol Supplementation on Vascular Endothelial Cell Expression of Nf-kB|The effect of calcitriol and cholecalciferol supplementation will be evaluated calculating the mean change in total vascular endothelial cell NFkB expression. NFkB expression is given as arbitrary units and represent ratios of endothelial cell protein expression to human umbilical vein endothelial cell (HUVEC) expression in order to account for any variation in the staining procedure.|6 months||||ratio of NFkB to HUVEC expression||Standard Deviation|Mean
2682436|NCT01384539|Secondary|Compare the Efficacy of Calcitriol and Cholecalciferol Supplementation on Plasma Concentrations of C-reactive Protein|Secondary aims are focused to explore whether vitamin D improves vascular endothelial function through decreases in inflammation|6 months||||mg/dL||Inter-Quartile Range|Median
2682437|NCT01384539|Primary|Compare the Difference Between the Calcitriol and Cholecalciferol Groups in Conduit Artery Endothelium-dependent Dilation (EDD) in Response to Treatment.|EDD will be measured by brachial artery flow-mediated dilation (FMD). The mean change in percent FMD from baseline will be documented.|6 months||||percent change in FMD||Standard Deviation|Mean
2682438|NCT01384292|Primary|Response (Responder/Non-responder) to Study Drug|Response (responder/non-responder) to study drug, where a responder was defined as having at least 3 rescue-free bowel movements (RFBMs) per week during the 4-week Part A treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks. An RFBM was defined as a bowel movement (BM) without rescue laxatives in the previous 24 hours.|Baseline to Week 4|All randomized patients|||Participants|||Number
2682439|NCT01384019|Secondary|Reperfusion Success|microvascular obstruction, myocardial salvage, and infarct size measured using post-PCI CMR|3-5 days|||||||
2682440|NCT01384019|Primary|Postinfarct Remodeling|postinfarct remodeling as evidenced by decreased left ventricular (LV) dilatation measured by CMR 6 months post PCI|6 months|Forty one patients underwent 6 month CMR in distal protection group and 43 patients, in conventional PCI group.|||Number of participants with remodeling|||Number
2682441|NCT01383993|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||hrs||Full Range|Median
2682442|NCT01383993|Secondary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration||Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2682443|NCT01383993|Secondary|Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration|AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2682444|NCT01383993|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||hrs||Full Range|Median
2682445|NCT01383993|Secondary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration||Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2682539|NCT01383499|Secondary|FEV1 Area Under the Curve From 0 to 3 h (AUC0-3h) Response|FEV1 (AUC0-3h) will be calculated as the area under the curve from 0 to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.|||Litre||Standard Error|Least Squares Mean
2682446|NCT01383993|Secondary|Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration|AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2682447|NCT01383993|Secondary|Ratio of AUC12,ss Following IV Administration Relative to AUC12,ss Following Oral Administration|Ratio was calculated from the following formula; AUC12,ss Following Oral Administration over AUC12,ss Following IV Administration|AUC12, ss for IV:Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion. AUC12,ss for oral: Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing.|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||ratio||Standard Deviation|Mean
2682448|NCT01383993|Primary|Number of Participants Assessed Visual Questionnaire||Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit|The safety analysis was performed on all subjects who received at least 1 dose of study medication.|||participants|||Number
2682449|NCT01383993|Primary|Number of Participants Assessed Color Vision Test||Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit|The safety analysis was performed on all subjects who received at least 1 dose of study medication.|||participants|||Number
2682450|NCT01383993|Primary|Number of Participants Assessed Near Distance Visual Acuity Test||Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit|The safety analysis was performed on all subjects who received at least 1 dose of study medication.|||participants|||Number
2682451|NCT01383993|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Oral Administration||Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||hrs||Full Range|Median
2682452|NCT01383993|Primary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following Oral Administration||Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2682453|NCT01383993|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following Oral Administration|AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2682454|NCT01383993|Primary|Time to Reach Maximum Observed Plasma Concentration (Tmax) Following IV Administration||Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||hrs||Full Range|Median
2682455|NCT01383993|Primary|Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following IV Administration||Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||mcg/mL||Geometric Coefficient of Variation|Geometric Mean
2682456|NCT01383993|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration|AUC12,ss was obtained by the Linear/Log trapezoidal method.|Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion|The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.|||μg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2682457|NCT01383954|Primary|Percent Change From Baseline in Pain Score During Week 2|Participants assessed their knee pain using a visual analog scale (VAS) where 0=no pain and 100=worst possible pain. Pain scores were recorded in an electronic diary prior to and 4 hours after the first daily application of diclofenac gel for breakthrough pain. The daily percent change in pain scores over the 7 days prior to Week 2 were averaged. Percent change from baseline (average pain score 7 days prior to first treatment) was calculated as (value at baseline - value at post-baseline visit)/ (value at baseline) x 100. A positive change from baseline indicates improvement.|Baseline and Week 2|Modified Intent-to-Treat Population, all participants who completed at least 50% of the study (at least 2 weeks of drug treatment), who had pain data available for analysis at the given timepoints.|||percent change||Standard Deviation|Mean
2682458|NCT01383954|Primary|Percent Change From Baseline in Pain Score During Week 1|Participants assessed their knee pain using a visual analog scale (VAS) where 0=no pain and 100=worst possible pain. Pain scores were recorded in an electronic diary prior to and 4 hours after the first daily application of diclofenac gel for breakthrough pain. The daily percent change in pain scores over the 7 days prior to Week 1 were averaged. Percent change from Baseline (average pain score 7 days prior to first treatment) was calculated as (value at baseline - value at post-baseline visit) / (value at baseline) x 100. A positive change from Baseline indicates improvement.|Baseline and Week 1|Modified Intent-to-Treat Population, all participants who completed at least 50% of the study (at least 2 weeks of drug treatment), who had pain data available for analysis at the given timepoints.|||percent change||Standard Deviation|Mean
2683472|NCT01375777|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.|||percent change||Standard Error|Least Squares Mean
2682459|NCT01383928|Secondary|Overall Survival|Overall survival was measured as the time from the date of first dose of study treatment to the time of death plus 1 day. For participants who did not die, survival was censored at the date of last contact. Overall Survival was analyzed using standard survival analysis techniques based on Kaplan-Meier estimates.|Baseline up to a follow-up of 62.1 months|mITT population included all participants who received at least 1 dose of any study drug in Phase 2 or who received at least 1 dose of any study drug and were treated at the phase 2 dose level during Phase 1.|||months||95% Confidence Interval|Median
2682460|NCT01383928|Secondary|Kaplan-Meier Estimate of Percentage of Participants Achieving Survival at Year 1|The Kaplan-Meier estimate reports the percentage of participants surviving at Year 1.|1 year after the first dose of study treatment|mITT population included all participants who received at least 1 dose of any study drug in Phase 2 or who received at least 1 dose of any study drug and were treated at the phase 2 dose level during Phase 1.|||percentage of participants||95% Confidence Interval|Number
2682461|NCT01383928|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of first dose of study treatment to the date of first documentation of progressive disease or to death due to any cause, whichever occurred first plus 1. PD: >=25% increase from lowest value in:serum/urine M-component; difference between involved,uninvolved FLC levels; bone marrow plasma cell percent; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. SD: not meeting criteria for CR, VGPR, PR, or PD. Participants who received ASCT or an alternate anticancer therapy were censored at the last response assessment that was SD or better before initiation of therapy. Participants without a response assessment were censored at the date of first dose. PFS was analyzed using standard survival analysis techniques based on Kaplan-Meier estimates.|Baseline up to a follow-up of 62.1 months|mITT population included all participants who received at least 1 dose of any study drug in Phase 2 or who received at least 1 dose of any study drug and were treated at the phase 2 dose level during Phase 1.|||months||95% Confidence Interval|Median
2682462|NCT01383928|Secondary|Time to Disease Progression (TTP)|Time to progression was defined as the time from the date of first dose of study treatment to the date of first documentation of PD + 1 day. Participants that did not experience PD will be censored at the last response assessment that is SD or better. PD: >=25% increase from lowest value in:serum/urine M-component; difference between involved, uninvolved FLC levels; bone marrow plasma cell percent; new bone lesions/soft tissue plasmacytomas development/existing bone lesions/soft tissue plasmacytomas size rise; hypercalcaemia development. SD: not meeting criteria for CR, VGPR, PR, or PD. Participants that received Autologous Stem Cell Transplantation (ASCT) or an alternate cancer therapy were also be censored at the last response assessment that is, SD or better prior to initiation of therapy. Participants without response assessment will be censored at the date of first dose. TTP was analyzed using standard survival analysis techniques based on Kaplan-Meier estimates.|Baseline up to a follow-up of 62.1 months|modified-intent-to-treat (mITT) population included all participants who received at least one dose of any study drug in Phase 2 or who received at least 1 dose of any study drug and were treated at the phase 2 dose level during Phase 1.|||months||95% Confidence Interval|Median
2682463|NCT01383928|Secondary|Phase 2: Duration of Response (DOR)|DOR was measured as the time from the date of first documentation of a confirmed response to the date of first documented PD. PD is defined as >=25% increase from lowest value in: serum/urine M-component; difference between involved, uninvolved FLC levels; bone marrow plasma cell percent; development of new bone lesions or soft tissue plasmacytomas development or increase in the size of existing bone lesions or soft tissue plasmacytomas; hypercalcaemia development.|Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)|Included a subset of response-evaluable population who achieved response.|||months||95% Confidence Interval|Median
2682464|NCT01383928|Secondary|Phase 2: Time to Response|Time to first response is defined as the time from the date of first dose of study treatment to the date of the first documentation of a confirmed response (PR or better) in a participant who responded + 1 day. PR as per IMWG criteria is 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by 90% or to <200 mg per 24 hours.|Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)|Response-evaluable population included all participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post-baseline response assessment.|||months||Full Range|Median
2682465|NCT01383928|Secondary|Phase 2: Percentage of Participants With Minimal Response (MR)|MR as per IMWG criteria is 25%-49% reduction in serum paraprotein and 50%-89% reduction in urine light chain excretion for 6 weeks.|Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2682466|NCT01383928|Secondary|Phase 2: Percentage of Participants With Partial Response (PR)|PR as per IMWG criteria is 50% reduction of serum M-protein and reduction in 24-hr urinary M-protein by 90% or to <200 mg per 24 hours.|Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2682467|NCT01383928|Secondary|Phase 2: Percentage of Participants With Near Complete Response (nCR)|nCR as per IMWG criteria is positive immunofixation analysis of serum or urine as the only evidence of disease; appearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow.|Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2682468|NCT01383928|Secondary|Phase 2: Percentage of Participants With Very Good Partial Response (VGPR)|VGPR as per IMWG criteria is serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours.|Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2682469|NCT01383928|Secondary|Phase 2: Percentage of Participants With Stringent Complete Response (sCR)|sCR as per IMWG criteria is CR plus normal FLC ratio and absence of clonal cells in bone marrow. CR is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow.|Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)|Response-evaluable population included all participants who received at least one 1 dose of ixazomib, had measurable disease at baseline, and at least one 1 post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2682470|NCT01383928|Secondary|Phase 2: Percentage of Participants With Complete Response (CR)|CR as per IMWG criteria is negative immunofixation on serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow.|Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2682471|NCT01383928|Secondary|Phase 2: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR) After Cycles 4, 8, and 16|CR as per IMWG criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours. VGPR were applicable only to participants who had measurable disease defined by at least 1 of the following 3 measurements: Serum M-protein; Urine M-protein; Serum FLC assay.|Cycles 4, 8, and 16|Response-evaluable population included all participants who received at least one 1 dose of ixazomib, had measurable disease at baseline, and at least one 1 post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2682472|NCT01383928|Secondary|Phase 2: Percentage of Participants With Overall Response (CR+VGPR+PR)|Overall response is defined as CR, VGPR or PR based on IMWG Response Criteria for malignant lymphoma. CR: disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. VGPR: serum, urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein+urine M-protein level <100 mg/24h. Partial response (PR) is a minimum of 50% decrease in sum of the product of the diameters of up to 6 of the largest dominant nodes or nodal masses and no increase in the size of other nodes.|Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment.|||percentage of participants||95% Confidence Interval|Number
2682473|NCT01383928|Secondary|Phase 1: Percentage of Participants With Best Overall Response|CR as per International Myeloma Working Group (IMWG) uniform criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow. Partial response(PR):>=50% reduction of serum M-protein,urinary M-protein by >=90%/to <200 mg/24 hr reduction.Near CR(nCR):positive immunofixation of serum/urine;soft tissue plasmacytomas disappearance;<=5% plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours. VGPR was applicable only to participants who had measurable disease defined by at least 1 of the following 3 measurements: Serum M-protein greater than or equal to (>=)1 g/dL; Urine M-protein >=200 mg/24 hours; Serum FLC assay level >=10 mg/dL, provided serum FLC ratio was abnormal.|Baseline until end of study treatment (Up to treatment Cycle 83 - approximately 2037 days)|Response-evaluable population included all participants who received at least 1 dose of ixazomib, had measurable disease at baseline, and at least 1 post-baseline disease assessment. Results were summarized together for all Phase 1 participants, as per planned analysis.|||percentage of participants||95% Confidence Interval|Number
2682474|NCT01383928|Secondary|Phase 1: Rac: Accumulation Ratio of Ixazomib|The accumulation ratio (Rac) was estimated as the ratio of AUC (0-72) on Day 11 to the AUC (0-72) on Day 1. AUC (0-72) is the area under the plasma concentration-time curve from time zero to 72 hours post-dose for ixazomib.|Cycle 1, Days 1 and 11|PK analysis population included all participants, who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 11 assessments were available.|||ratio||Standard Deviation|Geometric Mean
2682475|NCT01383928|Secondary|Phase 1: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib|Tmax: Time to reach the first maximum plasma concentration (Cmax), equal to time (hours) to Cmax of ixazomib after administration, obtained directly from the plasma concentration-time curve.|Cycle 1, Days 1 and 11|PK analysis population included all participants, who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 11 assessments were available.|||hours||Full Range|Median
2682476|NCT01383928|Secondary|Phase 1: AUC(0-72): Area Under the Plasma Concentration-Time Curve From Time 0 to 72 Hours Postdose for Ixazomib|AUC(0-72) is a measure of the area under the plasma concentration time-curve from time zero to 72 hours post-dose for ixazomib.|Cycle 1, Days 1 and 11|PK analysis population included all participants, who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 11 assessments were available.|||hour*nanogram per milliliter (hr*ng/mL)||Standard Deviation|Geometric Mean
2682477|NCT01383928|Secondary|Phase 1: Cmax: Maximum Plasma Concentration for Ixazomib|Maximum observed plasma concentration (Cmax) is the peak plasma concentration of ixazomib, obtained directly from the plasma concentration-time curve.|Cycle 1, Days 1 and 11|Pharmacokinetic (PK) analysis population included all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of PK parameters where Days 1 and 11 assessments were available.|||nanogram per milliliter (ng/mL)||Standard Deviation|Geometric Mean
2682540|NCT01383499|Secondary|FVC Trough Response|The trough FVC response is defined as the pre-dose FVC measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.|||Litre||Standard Error|Least Squares Mean
2684389|NCT01368497|Secondary|Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
2682478|NCT01383928|Primary|Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Study Drug Discontinuation|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 30 days after the last dose of study drug (approximately 1905 days)|Safety population included all participants who received at least 1 dose of any study drug.|||percentage of participants|||Number
2682479|NCT01383928|Primary|Phase 2: Percentage of Participants Experiencing Serious Adverse Events|A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.|Baseline up to 30 days after the last dose of study drug (approximately 1905 days)|Safety population included all participants who received at least one dose of any study drug.|||percentage of participants|||Number
2682480|NCT01383928|Primary|Phase 2: Percentage of Participants With Grade 3 or Higher Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. As per Common Terminology Criteria for Adverse Events v4.0 (CTCAE), Grade 3 = AE with severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4 = AE with life-threatening consequences; urgent intervention indicated and Grade 5 = Death related to AE.|Baseline up to 30 days after the last dose of study drug (approximately 1905 days)|Safety population included all participants who received at least 1 dose of any study drug.|||percentage of participants|||Number
2682481|NCT01383928|Primary|Phase 2: Percentage of Participants With Complete Response (CR) + Very Good Partial Response (VGPR)|CR as per International Myeloma Working Group (IMWG) uniform criteria is defined as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and <5% plasma cells in bone marrow. VGPR as per IMWG criteria is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hours. VGPR was applicable only to participants who had measurable disease defined by at least 1 of the following 3 measurements: Serum M-protein greater than or equal to (>=)1 g/dL; Urine M-protein >=200 mg/24 hours; Serum FLC assay level >=10 mg/dL, provided serum FLC ratio was abnormal.|Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)|Response-evaluable population included all participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post-baseline response assessment.|||percentage of participants||95% Confidence Interval|Number
2682482|NCT01383928|Primary|Phase 1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Vital signs included body temperature, blood pressure and heart rate.|Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)|Safety population included all participants who received at least 1 dose of any study drug.|||Participants|||Count of Participants
2682483|NCT01383928|Primary|Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAE) Related to Neurotoxicity|TEAE related to neurotoxicity grading based on common terminology criteria for adverse events (CTACE) version 4.03 are reported. Grade 1= mild; Grade 2= moderate; within normal limits, Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= life-threatening consequences; urgent intervention indicated; Grade 5= death. Only TEAEs related to neurotoxicity with values are reported.|Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)|Safety population included all participants who received at least 1 dose of any study drug and reported baseline and at least 1 post-baseline value.|||Participants|||Count of Participants
2682484|NCT01383928|Primary|Phase 1: Number of Participants With Markedly Abnormal Laboratory Values Reported as Treatment Emergent Adverse Events (TEAEs)|Laboratory tests included chemistry, hematology and urinalysis. Abnormal laboratory value was assessed as an AE if the value lead to discontinuation or delay in treatment, dose modification, therapeutic intervention, or was considered by the investigator to be a clinically significant change from baseline. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)|Safety population included all participants who received at least 1 dose of any study drug and reported baseline and at least 1 post-baseline value.|||Participants|||Count of Participants
2682485|NCT01383928|Primary|Phase 1: Percentage of Participants Experiencing 1 or More Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.|Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)|Safety population included all participants who received at least 1 dose of any study drug.|||percentage of participants|||Number
2682486|NCT01383928|Primary|Phase 1: Recommended Phase 2 Dose (RP2D)|The RP2D of ixazomib was determined after the evaluation of the available data from the phase 1 portion of the trial which included, but was not limited to analyses of efficacy results, toxicity characterization, all grades peripheral neuropathy, and treatment discontinuation. The maximum number of cycles received was 83 cycles (approximately up to 2037 days).|Cycle 1 (21 days)|Safety population included all participants who received at least 1 dose of any study drug.|||mg|||Number
2682487|NCT01383928|Primary|Phase 1: Maximum Tolerated Dose (MTD)|MTD was highest dose of ixazomib given with combination drugs, at which <=1 of 6 participants experienced dose-limiting toxicity (DLT) during Cycle 1 of Phase 1. DLT defined as any of following considered possibly related to therapy: Grade 4 neutropenia (absolute neutrophil count [ANC] <500 cell per cubic millimeter [cells/mm^3]) for >7 days; Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia for >7 days; Grade 3 thrombocytopenia with clinically significant bleeding; platelet count <10,000/mm^3; Grade 2 peripheral neuropathy with pain or >=Grade 3 peripheral neuropathy; >=Grade 3 nausea/emesis, diarrhea controlled by supportive therapy; any >=Grade 3 nonhematologic toxicity except Grade 3 arthralgia/myalgia; or <1 week Grade 3 fatigue; delay in initiation of the subsequent therapy cycle by >14 days; <=80% lenalidomide doses administered due to other >=Grade 2 combination study drug-related nonhematologic toxicities requiring therapy discontinuation.|Cycle 1 (21 days)|DLT-evaluable population included all participants who received all Cycle 1 doses of MLN9708 and completed Cycle 1 procedures, or experienced a DLT in Cycle 1 in Phase 1.|||mg|||Number
2682488|NCT01383759|Secondary|Organ Response - Renal Involvement at 24 Months|24 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.|24 months|1 participants died at the previous 12 month follow up point|||Participants|||Count of Participants
2682489|NCT01383759|Secondary|Organ Response - Renal Involvement at 12 Months|12 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.|12 months||||Participants|||Count of Participants
2682490|NCT01383759|Secondary|Organ Response - Cardiac Involvement at 24 Months|24 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.|24 months||||Participants|||Count of Participants
2682491|NCT01383759|Secondary|Progression Free Survival at 24 Months|following the 3-phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.|24 months||||percentage of patients||95% Confidence Interval|Number
2682492|NCT01383759|Secondary|Organ Response - Cardiac Involvement at 12 Months|12 months post-initiation of treatment following the 3 phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.|12 months||||Participants|||Count of Participants
2682493|NCT01383759|Secondary|To Estimate the Hematologic Response Rate|[Complete Response (CR) (Normalization of the free light chain (FLC)levels and ratio; Negative serum and urine ; <5% plasma cells in bone marrow), Very Good Partial Response (VGPR) (Reduction in the dFLC (difference between involved [iFLC] and uninvolved FLC) to<4mg/dl) and Partial Response (PR)] (>/= 50% reduction in the dFLC), achieved at 12 month, and at 24 months post-initiation of treatment following the 3-phase comprehensive treatment approach.|2 years||||Participants|||Count of Participants
2682494|NCT01383759|Primary|Participants Evaluated for Toxicity|Toxicities will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0.|2 years||||Participants|||Count of Participants
2682495|NCT01383759|Primary|Percentage of Participants Experiencing Progression Free Survival at 12 Months|of a 3-phase comprehensive treatment approach including induction with BD followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis.|12 months|Data were not collected for MIDD group.|||percentage of patients||95% Confidence Interval|Number
2682496|NCT01383720|Other Pre-specified|Acute Kidney Injury - Stage 2 or 3|"Stage 2: Increase in serum creatinine to 200-300% (2.0-3.0 times increase compared with baseline).~Stage 3: Increase in serum creatinine to ≥ 300% (> 3 times increase compared with baseline) or serum creatinine of ≥ 4.0 mg/d (≥ 354 μmol/L) with an acute increase of at least 0.5 mg/dl (44 μmol/L). Subjects receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria."|Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
2682497|NCT01383720|Other Pre-specified|Bleeding|"Life-threatening or Disabling Bleeding~Fatal bleeding OR~Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome OR~Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery OR~Overt source of bleeding with drop in hemoglobin of ≥5 g/dL or whole blood or packed red blood cells (RBC) transfusion ≥4 units~Major Bleeding~Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC AND~Does not meet criteria of life-threatening or disabling bleeding"|Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
2682498|NCT01383720|Other Pre-specified|New Conduction Disturbances or Arrhythmias Requiring Permanent Pacemaker||Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
2682499|NCT01383720|Other Pre-specified|Major Vascular Complication|"Any thoracic aortic dissection~Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, or compartment syndrome) leading to either death, need for significant blood transfusions (≥4 units), unplanned percutaneous or surgical intervention, or irreversible end-organ damage (e.g. hypogastric artery occlusion causing visceral ischemia or spinal artery injury causing neurologic impairment)~Distal embolization (non-cerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage"|Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
2682500|NCT01383720|Other Pre-specified|Urgent/Emergent Conversion to Surgery or Repeat Procedure for Valve-related Dysfunction||Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
2682501|NCT01383720|Other Pre-specified|Major Stroke|Confirmed with a Modified Rankin score >/= 2 at 30 and 90 days|Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
2684266|NCT01369329|Secondary|Number of Participants in Clinical Remission at Week 8|Clinical remission is defined as a CDAI score of less than (<) 150 points at Week 8.|Baseline and Week 8|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
2682502|NCT01383720|Other Pre-specified|Peri-procedural Myocardial Infarction|"Peri-Procedural Myocardial Infarction (≤72 hours after the index procedure)~New ischemic symptoms (e.g., chest pain or shortness of breath), or new ischemic signs (e.g. ventricular arrhythmias, new or worsening heart failure, new ST-segment changes, hemodynamic instability, or imaging evidence of new loss of viable myocardium or new wall motion abnormality), AND~Elevated cardiac biomarkers (preferably creatine kinase-myoglobin band) within 72 h after the index procedure, consisting of two or more post-procedure samples that are > 0.6 to 8 h apart with a 20% increase in the second sample and a peak value exceeding 10X the 99th percentile upper reference limit (URL), or a peak value exceeding 5X the 99th percentile URL with new pathological Q waves in at least 2 contiguous leads"|72 hours||||participants|||Number
2682503|NCT01383720|Other Pre-specified|Death||Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
2682504|NCT01383720|Other Pre-specified|Aortic Valve Area|As determined by echocardiography|Discharge or 7 days post-procedure, whichever comes first||||cm^2||Standard Deviation|Mean
2682505|NCT01383720|Other Pre-specified|Mean Aortic Valve Gradient|As determined by echocardiography|Discharge or 7 days post-procedure, whichever comes first||||mm Hg||Standard Deviation|Mean
2682506|NCT01383720|Other Pre-specified|No Major Adverse Cardiovascular and Cerebrovascular Events Through Discharge|Major adverse cardiovascular or cerebrovascular events include all-cause mortality, periprocedural myocardial infarction ≤72 hours, major stroke, urgent/emergent conversion to surgery or repeat procedure for valve-related dysfunction|Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
2682507|NCT01383720|Other Pre-specified|Single Valve Implanted in the Proper Anatomical Location||procedure||||participants|||Number
2682508|NCT01383720|Other Pre-specified|Intended Performance of the Lotus Valve|Aortic valve area >1.0 cm2 plus either a mean aortic valve gradient <20 mmHg or peak velocity <3m/sec, without moderate or severe prosthetic valve aortic regurgitation|At time of discharge or 7 days post procedure||||participants|||Number
2682509|NCT01383720|Other Pre-specified|Successful Access, Device Delivery, Deployment and Positioning and Retrieval of Delivery System||Procedure||||participants|||Number
2682510|NCT01383720|Secondary|Paravalvular Aortic Regurgitation|As determined by echocardiography|Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
2682511|NCT01383720|Secondary|Central Aortic Regurgitation|As determined by echocardiography|Discharge or 7 days post-procedure, whichever comes first||||participants|||Number
2682512|NCT01383720|Secondary|Device Performance Endpoint-Valve Retrieval, if Attempted|Successful retrieval of the Lotus Valve System if retrieval is attempted|procedure||||participants|||Number
2682513|NCT01383720|Secondary|Device Performance Endpoint-Repositioning|Successful repositioning of the Lotus Valve System if repositioning is attempted|procedure|Patients in whom repositioning of the Lotus Valve was attempted|||participants|||Number
2682514|NCT01383720|Primary|Clinical Procedural Success|Clinical procedural success defined as successful implantation of a Lotus Valve System (Device Success) without in-hospital Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) through discharge or 7 days post-procedure, whichever comes first.|Discharge or 7 days post-procedure, whichever comes first|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis|||participants|||Number
2682515|NCT01383707|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first study drug administration to the date of death due to any cause. Participants who were alive at the time of the analysis were censored at the last date the participant was known to be alive. OS was calculated as follows: OS (months) = ([Date of Death - first study drug administration] + 1)/30|End of study up to approximately 3 years|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.|||months||95% Confidence Interval|Median
2682516|NCT01383707|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of first study drug administration to the date of disease progression or death due to any cause, whichever came first. Progression was defined according to RECIST, v1.1 as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Participants, who did not progress were censored at the date of the last assessment performed. Participants who withdrew from the study without documented progression and for whom an electronic case report form (eCRF) existed as evidence that evaluations had been made, were censored at the date of the last tumor assessment when the participant was known to be progression-free. Participants without post-baseline tumor assessments, but known to be alive were censored at the time of first study drug administration. PFS was calculated: PFS (months) = ([Date of Event - Date of first study drug administration] + 1)/30.|End of study up to approximately 3 years|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.|||months||95% Confidence Interval|Median
2682517|NCT01383707|Secondary|Disease-free Interval (DFI)|DFI was defined as the time from the date of R0/R1 surgery to the date of disease relapse or death due to any cause. Participants who did not progress were considered censored at the date of the last assessment performed. For participants receiving two-stage resection, the date of R0/R1 surgery was the date of the second surgery. Participants, who did not receive surgery and participants without R0/R1 surgery were censored at Day 1. DFI was calculated as follows: DFI (months) = ([Date of R0/R1 surgery ‐ Date of 1st relapse/Death] + 1)/30|End of study up to approximately 3 years|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.|||months||95% Confidence Interval|Median
2682518|NCT01383707|Secondary|Percentage of Participants Achieving No Residual Tumor (R0)/Surgical Margin With Microscopic Residual Tumor (R1) Liver Resection|The percentage of participants achieving R0/R1 liver resection was defined as the percentage of participants achieving R0 surgery (no residual tumor) plus percentage of participants achieving R1 surgery (surgical margin with microscopic residual tumor).|End of study up to approximately 3 years|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.|||percentage of participants||95% Confidence Interval|Number
2682541|NCT01383499|Secondary|Forced Vital Capacity (FVC) Peak (0-3h) Response|The FVC peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FVC measured within the first 3 hours post dosing and the FVC baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.|||Litre||Standard Error|Least Squares Mean
2682519|NCT01383707|Primary|Objective Response Rate (ORR) in the Per-protocol Analysis Set (PPAS)|ORR was defined as the percentage of participants with shrinkage (PR) or disappearance of cancer (CR). Tumor response was evaluated according to the RECIST v1.1. The same method of tumor measurement and assessment had to be used to characterize each lesion throughout the study. Tumor assessment consisted of CT scan (abdomen + pelvis + chest) or CE-MRI (abdomen + pelvis) + non CE-CT (chest) according to the choice of the center. CR, Disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.|Up to 11 cycles of treatment (up to Week 22)|The PPAS included all subjects in the ITT set, who did not experience any major protocol violations.|||percentage of participants||95% Confidence Interval|Number
2682520|NCT01383707|Primary|Objective Response Rate (ORR) in the Intent-to-treat (ITT) Analysis Set|ORR was defined as the percentage of participants with shrinkage (partial response [PR]) or disappearance of cancer (complete response [CR]). Tumor response was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). The same method of tumor measurement and assessment had to be used to characterize each lesion throughout the study. Tumor assessment consisted of computerized tomography (CT) scan (abdomen + pelvis + chest) or contrast-enhanced magnetic resonance imaging (CE-MRI) (abdomen + pelvis) + non CE-CT (chest) according to the choice of the center. CR, Disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 11 cycles of treatment (up to Week 22)|The ITT set, which included all enrolled participants, who received at least one dose of any study medication.|||percentage of participants||95% Confidence Interval|Number
2682521|NCT01383681|Primary|Physician Assessment of Spasticity|The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.|Month 12|Planned analysis: All participants. Not enough data was collected for analysis of this outcome measure.||||||
2682522|NCT01383681|Primary|Physician Assessment of Spasticity|The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.|Baseline|Planned analysis: All participants. Not enough data was collected for analysis of this outcome measure.||||||
2682523|NCT01383616|Secondary|Middle Vertebral Body Height Restoration Following Surgery With Kyphoplasty|Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the middle vertebral body heights.|Preoperative assessment within 3 weeks before surgery and postoperative day 1|Pre and postoperative measurements were available for 14 patients in the unipedicular group, and 17 patients in the bipedicular group.|||percent change||Standard Deviation|Mean
2682524|NCT01383616|Secondary|Comparison of 12 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups|A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.[1] It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. The scale is from 1-10 with 10 as the highest level of pain, and 0 being no pain|12 months post-op|From the period of intervention to 12 month follow-up, 9 total patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 14 patients from this arm at 12 months. 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.|||units on a scale||Standard Deviation|Mean
2682525|NCT01383616|Secondary|Comparison of 12 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups|The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. A score of 0 indicates no back pain, while a score of 24 indicates significant back pain.|12 months post-op|From the period of intervention to 12 month follow-up, 9 total patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 14 patients from this arm at 12 months. 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.|||units on a scale||Standard Deviation|Mean
2682526|NCT01383616|Secondary|Comparison of 12 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups|Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.[2] The scores for all questions answered are summed. Zero is equated with no disability and 50 is the maximum disability possible|12 months post-op|From the period of intervention to 12 month follow-up, 9 total patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 14 patients from this arm at 12 months. 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.|||units on a scale||Standard Deviation|Mean
2682527|NCT01383616|Secondary|Comparison of 3 Month VAS Score Between Unipedicular and Bipedicular Kyphoplasty Groups|A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.[1] It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. The scale is from 1-10 with 10 as the highest level of pain, and 0 being no pain|3 months post-op|From the period of intervention to 3 month follow-up, 5 patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months. 3 patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months.|||units on a scale||Standard Deviation|Mean
2682542|NCT01383499|Secondary|Trough FEV1 Response|The trough FEV1 is defined as the pre-dose FEV1 measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.|||Litre||Standard Error|Least Squares Mean
2682839|NCT01380782|Secondary|Safety Profile as Summarized With Descriptive Statistics (Using Toxicity Data Gathered on Trial)|Safety profile in both populations - as adverse events are posted separately in detail, these results will demonstrate serious adverse events (defined as grades 3-5) that were judged at least possibly related to Nintedanib (BIBF 1120).|2 years||||number of incidents|||Number
2682528|NCT01383616|Secondary|Comparison of 3 Month RDQ Score Between Unipedicular and Bipedicular Kyphoplasty Groups|The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. A score of 0 indicates no low back pain, while a score of 24 indicates significant low back pain.|3 months post-op|From the period of intervention to 3 month follow-up, 5 patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months. 3 patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months.|||units on a scale||Standard Deviation|Mean
2682529|NCT01383616|Secondary|Measurement of Change in Kyphotic (Cobb) Angle Following Kyphoplasty|Preoperative and postoperative thoracolumbar radiographs used to calculate the change in kyphotic (Cobb) angle of the spine following surgery|Preoperative assessment within 3 weeks before surgery and postoperative day 1|Pre and postoperative measurements were available for 14 patients in the unipedicular group, and 17 patients in the bipedicular group.|||percent change||Standard Deviation|Mean
2682530|NCT01383616|Secondary|Anterior Vertebral Body Height Restoration Following Surgery With Kyphoplasty|Preoperative and postoperative thoracolumbar radiographs were used to calculate the percent changes of the anterior vertebral body heights.|Preoperative assessment within 3 weeks before surgery and postoperative day 1|Pre and postoperative measurements were available for 14 patients in the unipedicular group, and 17 patients in the bipedicular group.|||percent change||Standard Deviation|Mean
2682531|NCT01383616|Primary|Change in RDQ in the Bipedicular Group From 3 to 12 Months|The Roland Morris Disability Questionnaire is a widely used health status measure for low back pain. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. A score of 0 indicates no low back pain, while a score of 24 indicates significant low back pain.|3-12 months post operation|From the period of intervention to 12 month follow-up, 6 total patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 15 patients from this arm at 12 months.|||units on a scale||Standard Deviation|Mean
2682532|NCT01383616|Primary|Comparison of 3 Month ODI Score Between Unipedicular and Bipedicular Kyphoplasty Groups|The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.|Preoperative questionnaire within 3 weeks before surgery and postoperative questionnaires at 3 months after surgery|From the period of intervention to 3 month follow-up, 5 patients were lost in the unipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months. 3 patients were lost in the bipedicular kyphoplasty arm, resulting in analysis of 18 patients from this arm at 3 months.|||units on a scale||Standard Deviation|Mean
2682533|NCT01383499|Secondary|Change From Baseline in Mean Number of Nighttime Awakenings|Mean number of nighttime awakenings due to asthma symptoms as assessed by patients eDiary incorporated in the AM3® device. Analysis adjusted for treatment, period, patient and baseline using a mixed model. The scores for this question used the following scale where: 1='Did not wake up', 2='Woke up once', 3='Woke up 2-5 times', 4='Woke up more than 5 times' and 5='Was awake all night'.|Baseline and last week of treatment (week 4)|"FAS with at least one on-treatment value. For outcome measures obtained by AM3 device one patient in the TioR2.5 group had no on-treatment data."|||scores on a scale||Standard Error|Least Squares Mean
2682534|NCT01383499|Secondary|Control of Asthma as Assessed by Asthma Control Questionnaire (ACQ)|ACQ is a questionnaire consisting of seven point Likert scale ranging from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The scale describes the frequency and severity of asthma symptoms. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|4 weeks|FAS with at least one on-treatment value.|||Score||Standard Error|Least Squares Mean
2682535|NCT01383499|Secondary|Change From Baseline in the Number of Puffs of Rescue Medication Per Period (24 h, Daytime and Night-time Use)|Mean number of inhalations (puffs) of unscheduled rescue salbutamol therapy during whole day (24 h, daytime and night-time use). Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|"FAS with at least one on-treatment value. For outcome measures obtained by AM3 device one patient in the TioR2.5 group had no on-treatment data."|||Puffs||Standard Error|Least Squares Mean
2682536|NCT01383499|Secondary|Mean Evening PEF Response|Mean Evening PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|"FAS with at least one on-treatment value. For outcome measures obtained by AM3 device one patient in the TioR2.5 group had no on-treatment data."|||Litre/min||Standard Error|Least Squares Mean
2682537|NCT01383499|Secondary|Mean Morning Peak Expiratory Flow (PEF) Response|Mean morning PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|"FAS with at least one on-treatment value. For outcome measures obtained by AM3 device one patient in the TioR2.5 group had no on-treatment data."|||Litre/min||Standard Error|Least Squares Mean
2682538|NCT01383499|Secondary|FVC Area Under the Curve From 0 to 3 h (AUC0-3h) Response|FVC (AUC0-3h) will be calculated as the area under the curve from 0 to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|FAS with at least one on-treatment value.|||Litre||Standard Error|Least Squares Mean
2682840|NCT01380782|Secondary|Time-to-tumor Progression|Time-to-tumor progression in both populations.|2 years||||days||95% Confidence Interval|Median
2682543|NCT01383499|Primary|Forced Expiratory Volume (FEV1) Peak (0-3h) Response|The FEV1 peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FEV1 measured within the first 3 hours post dosing and the FEV1 baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.|Baseline and 4 weeks|The Full analysis set (FAS) is defined as patients randomised, treated, with baseline data and at least one on-treatment efficacy measurement after 4 weeks on treatment within a period.|||Litre||Standard Error|Least Squares Mean
2682544|NCT01383486|Secondary|The Percentage of Low Literacy Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours|In addition to the primary outcome measure evaluated for all selection evaluable participants, this secondary outcome was evaluated separately for low literacy participants. Low Literacy Participants are defined as those who had REALM (Rapid Estimate of Adult Literacy in Medicine) score </= 60 at visit 1.|Up to 14 days|Subgroup of Selection Evaluation Population: low literacy participants who had REALM score </= 60 at visit 1 and chose naproxen sodium.|||Percentage of participants|||Number
2682545|NCT01383486|Secondary|The Percentage of Participants Who Selected Naproxen Sodium ER , Expected Their Pain to Last More Than 12 Hours and Reported Their Selection Decision Within First 24 Hours||Within 24 hours of their selection decision taken up to 14 days|Subgroup of Selection Evaluation Population|||Percentage of participants|||Number
2682546|NCT01383486|Primary|The Percentage of Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours|Participants were instructed to select a product for use upon their pain episode and then call a toll-free number for an interview within 30 minutes of the selection decision. Participants who did not call were interviewed after 14 days for data collection. The primary endpoint was derived from 2 variables: 1) number of participants who selected Naproxen Sodium ER and reported expected duration of pain less than or equal to 12 hrs (A); 2) number of participants who selected Naproxen Sodium ER and report expected duration of pain greater than 12 hrs (B). The results was calculated as B/(A+B).|up to 14 days|Only subjects who chose naproxen sodium were included in the analysis.|||Percentage of participants|||Number
2682547|NCT01383447|Secondary|Predictive Values of Levels of Flow Cytometric Minimal Residual Disease (MRD) on Duration of Progression Free Survival for the Study Population|Kaplan-Meier PFS curves and cumulative incidence of progression curves will be generated for patients above vs. below each threshold, and log rank will be used to compare the curves.|Day 29|This study was halted prematurely by the NCI for low accrual. No results were analyzed.||||||
2682548|NCT01383447|Secondary|Comparative Pharmacokinetics (PK) and Pharmacodynamics (PD) of Entinostat Alone vs. Entinostat Plus Imatinib Mesylate|Entinostat concentrations will be compared when administered alone or in combination with imatinib by paired Student's t test (day 4 vs 11 concentrations) or Wilcoxon signed rank tests as appropriate. Association between exposure parameters and PD endpoints (e.g., apoptosis, histone acetylation, BCR-ABL expression) will be assessed using Fisher's exact tests or Wilcoxon rank sum tests as appropriate.|Day 4 and 11|This study was halted prematurely by the NCI for low accrual. No results were analyzed.||||||
2682549|NCT01383447|Secondary|Progression Free Survival (PFS) for Adults With Relapsed/Refractory Ph+ ALL Treated With Combination of Entinostat and Imatinib Mesylate|The Kaplan-Meier estimator will be used to estimate PFS with a 95% confidence interval from study entry.|At 1 year|This study was halted prematurely by the NCI for low accrual. No results were analyzed.||||||
2682550|NCT01383447|Secondary|Rate of Complete Response (CR) for Adults With Relapsed/Refractory Ph+ ALL Treated With a Combination of Entinostat (at the Dose Determined in Phase 1) and Imatinib Mesylate||Up to 30 days post-treatment|This study was halted prematurely by the NCI for low accrual. No results were analyzed.||||||
2682551|NCT01383447|Primary|Maximum Tolerated Dose (MTD) of Entinostat When Given in Combination With Imatinib Mesylate|The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.|Up to 30 days post-treatment|This study was halted prematurely by the NCI for low accrual. No results were analyzed.||||||
2682552|NCT01383421|Other Pre-specified|PSP Satisfaction Questionnaire Responses at Week 78|The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.|Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.|||percentage of participants|||Number
2682553|NCT01383421|Other Pre-specified|PSP Satisfaction Questionnaire Responses at Week 52|The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.|Week 52|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.|||percentage of participants|||Number
2682554|NCT01383421|Other Pre-specified|PSP Satisfaction Questionnaire Responses at Week 24|The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.|Week 24|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.|||percentage of participants|||Number
2682555|NCT01383421|Other Pre-specified|PSP Satisfaction Questionnaire Responses at Week 12|The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented.|Week 12|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases.|||percentage of participants|||Number
2682841|NCT01380782|Secondary|Overall Survival|Overall survival in both populations|2 years||||months||95% Confidence Interval|Median
2682556|NCT01383421|Other Pre-specified|Change From Baseline Means in the Beliefs About Medicines Questionnaire (BMQ) at Week 78|The BMQ consists of 11 questions used to assess the participant's beliefs about medication and the necessity of medications prescribed to them for rheumatoid arthritis. Each question answered from 'strongly disagree' to 'strongly agree,' with some questions attributed to the necessity sub-scale, and others to the concern sub-scale. Each answer is scaled from 1 to 5. The necessity sub-scale is calculated by taking the average of necessity scores, and the concern sub-scale is calculated by taking the average of the concern scores. Higher scores on the necessity sub-scale represent the stronger perceptions of the participant for the necessity of their medication. Similarly, higher scores on the concerns sub-scale represent stronger concerns about the potential negative effects of their medications.|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing Baseline and at least 1 non-missing post-Baseline value. Observed cases.|||units on a scale||Standard Deviation|Mean
2682557|NCT01383421|Other Pre-specified|Percentage of Participants Who Started at Level 3 (or Above) at Baseline and Remained at Level 3 or Improved to Level 4 on the PAM-13 at Week 78|The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management.|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and were at Level 3 or 4 at Baseline. Non-responder imputation.|||percentage of participants|||Number
2682558|NCT01383421|Other Pre-specified|Percentage of Participants Who Started and Remained at Level 4 From Baseline to Week 78 on the PAM-13|The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management.|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and were at Level 4 at Baseline. Non-responder imputation.|||percentage of participants|||Number
2682559|NCT01383421|Other Pre-specified|Percentage of Participants Who Demonstrated Improvement From Baseline or Who Remained at Level 4 From Baseline on the Patient Activation Measure (PAM-13) at Week 78|The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management.|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.|||percentage of participants|||Number
2682560|NCT01383421|Other Pre-specified|Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78|"The CQR includes 19 items and measures RA treatment-specific compliance/adherence. Participants select an answer based on whether they agree with each statement. The agreements are based on a 4-point Likert scale with anchors don't agree at all (score = 1), don't agree (score = 2), agree (score = 3), and agree very much (score = 4). The total score is calculated by summing all 19 items and subtracting 19 from the total and dividing by 0.57. The compliance score ranges between 0 (complete non-compliance) to 100 (perfect compliance)."|Baseline, Week 24, 52, and 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2682561|NCT01383421|Other Pre-specified|Mean Change From Baseline in TSQM Scores at Week 78|TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2682562|NCT01383421|Other Pre-specified|Mean Change From Baseline in TSQM Scores at Week 52|TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).|Baseline, Week 52|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2682563|NCT01383421|Other Pre-specified|Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24|TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction).|Baseline, Week 24|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2682564|NCT01383421|Other Pre-specified|Mean Change From Baseline in WPAI at Week 78|"The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating RA had no effect on this and 10 indicating RA completely prevented me from this. A decrease in the WPAI score indicates improvement."|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2682565|NCT01383421|Other Pre-specified|Mean Change From Baseline in WPAI at Week 52|"The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating RA had no effect on this and 10 indicating RA completely prevented me from this. A decrease in the WPAI score indicates improvement."|Baseline, Week 52|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2682566|NCT01383421|Other Pre-specified|Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24|"The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating RA had no effect on this and 10 indicating RA completely prevented me from this. A decrease in the WPAI score indicates improvement."|Baseline, Week 24|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2682567|NCT01383421|Other Pre-specified|Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78|"A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the DAS28(CRP) score. The DAS28(CRP) score ranges from 0-10, with higher scores indicating more disease activity.~A Good Response is defined as an improvement (decrease) in the DAS28 of >1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.~A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or, an improvement (decrease) in the DAS28 of > 1.2 from Baseline and attainment of a DAS28 score of > 3.2.~No Response is defined as either an improvement (decrease) in the DAS28 of ≤ 0.6, or an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 and attainment of a DAS28 of > 5.1"|Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing visit values. Observed cases.|||percentage of participants|||Number
2682568|NCT01383421|Other Pre-specified|Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78|"A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the DAS28(ESR) score. The DAS28(ESR) score ranges from 0-10, with higher scores indicating more disease activity.~A Good Response is defined as an improvement (decrease) in the DAS28 of > 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.~A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or, an improvement (decrease) in the DAS28 of > 1.2 from Baseline and attainment of a DAS28 score of > 3.2.~No Response is defined as either an improvement (decrease) in the DAS28 of ≤ 0.6, or an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 and attainment of a DAS28 of > 5.1"|Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing visit values. Observed cases.|||percentage of participants|||Number
2682569|NCT01383421|Other Pre-specified|Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78|"ACR20/50/70 response is a 20%/50%/70% improvement in a participant's disease condition compared to Baseline. A participant is considered an ACR20/50/70 responder if the following 3 criteria are met: ≥ 20/50/70% improvement in 28 tender joint count; ≥ 20/50/70% improvement in swollen joint count; ≥ 20/50/70% improvement in at least 3 of the following 5 assessments:~Patient's assessment of pain~Patient's global assessment of disease activity~Physician's global assessment of disease activity~HAQ-DI~Acute phase reactant value (CRP or erythrocyte sedimentation date [ESR])"|Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing visit values. Observed cases.|||percentage of participants|||Number
2682570|NCT01383421|Other Pre-specified|Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78|The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a visual analogue scale from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission.|Baseline, Weeks 24, 52, and 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2682571|NCT01383421|Other Pre-specified|Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78|The SDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission.|Baseline, Weeks 24, 52, and 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2682572|NCT01383421|Other Pre-specified|Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78|The DAS28 is a validated combined index of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher numbers indicating more disease activity.|Baseline and Weeks 24, 52, 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward.|||units on a scale||Standard Deviation|Mean
2682573|NCT01383421|Secondary|Percentage of Participants Achieving a MCID in the HAQ-DI at Week 64|The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.|Baseline, Week 64|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.|||percentage of participants||95% Confidence Interval|Number
2682574|NCT01383421|Secondary|Percentage of Participants Achieving a MCID in the HAQ-DI at Week 52|The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.|Baseline, Week 52|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.|||percentage of participants||95% Confidence Interval|Number
2682575|NCT01383421|Secondary|Percentage of Participants Achieving a MCID in the HAQ-DI at Week 36|The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.|Baseline, Week 36|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.|||percentage of participants||95% Confidence Interval|Number
2682576|NCT01383421|Secondary|Percentage of Participants Achieving a MCID in the HAQ-DI at Week 24|The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.|Baseline, Week 24|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.|||percentage of participants||95% Confidence Interval|Number
2682577|NCT01383421|Secondary|Percentage of Participants Achieving a MCID in the HAQ-DI at Week 12|The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.|Baseline, Week 12|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.|||percentage of participants||95% Confidence Interval|Number
2682578|NCT01383421|Primary|Percentage of Participants Achieving a Minimal Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 78|The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline.|Baseline, Week 78|Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation.|||percentage of participants|||Number
2682579|NCT01383356|Secondary|Area Under the Curve 0 to Inf (AUC0-inf)|AUC0-inf is the area under the concentration versus time curve of metformin in plasma from time zero extrapolated to infinity.|Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period|All subjects having all samples in all periods and subjects who missed samples that may not affect the estimation of pharmacokinetic parameters in any period|||ng*h/ml||Standard Deviation|Mean
2682610|NCT01383096|Primary|OZ439 t1/2|Apparent terminal half life (t1/2)|1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing|Pharmacokinetic Population: all subjects who received study drug, and completed at least one treatment (provided they had adequate OZ439 plasma concentration data) were included in the pharmacokinetic analysis.|||hours||Geometric Coefficient of Variation|Geometric Mean
2682580|NCT01383356|Primary|Area Under the Curve 0 to Last Measurable Value (AUC0-t)|AUC0-t is the area under the concentration versus time curve of metformin in plasma, from time zero (0) to the time of the last measurable analyte concentration (t), as calculated by the linear trapezoidal method.|Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period|All subjects having all samples in all periods and subjects who missed samples that may not affect the estimation of pharmacokinetic parameters in any period|||ng*h/ml||Standard Deviation|Mean
2682581|NCT01383356|Primary|Maximum Plasma Concentration (Cmax)|Maximum measured concentration of metformin in plasma, per period.|Prior to drug administration and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 16, 24, 30, and 36 hours post dose in each treatment period|All subjects having all samples in all periods and subjects who missed samples that may not affect the estimation of pharmacokinetic parameters in any period.|||ng/ml||Standard Deviation|Mean
2682582|NCT01383317|Secondary|Pain Unpleasantness|Pain unpleasantness will be measured on postoperative day (POD) 1 and 2 by using a 0-10 verbal scale after asking the subject to cough. Higher scores denotes more intensity and unpleasantness of pain.|Postoperative day 1 and postoperative day 2|Data was not collected on some participants in both groups because they refused to answer or they were discharged.|||units on a scale||Standard Deviation|Mean
2682583|NCT01383317|Secondary|Patient Verbal Assessment as to Whether They Received Active Treatment or Placebo|Participants were questioned to see if they knew what interventional group they belonged to.|Postoperative day 1 and postoperative day 2|Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged.|||Participants|||Count of Participants
2682584|NCT01383317|Secondary|Leg Pain at 48 Hours|Number of participants that had leg pain at 48 hours.|postoperative day 2|Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged.|||Participants|||Count of Participants
2682585|NCT01383317|Secondary|McGill Pain Sensory|The McGill Pain Questionnaire (MPQ) is a three-part pain assessment tool that measures several dimensions of the patient's pain experience. The scale range is 0-78, with higher scores denoting worse outcomes.|Postoperative day 1 and postoperative day 2|Population differs from participant flow, because some participants in each group did not complete the assessment.|||units on a scale||Standard Deviation|Mean
2682586|NCT01383317|Secondary|Level of Sedation|The Ramsey Sedation Scale (RSS) was used to determine the level of sedation. Th RSS defines the conscious state from a level 1: the patient is anxious, agitated or restless, through the continuum of sedation to a level 6: the patient is completely unresponsive. The score range is from 1-6, with higher scores denoting worse outcomes.|Postoperative day 1 and postoperative day 2|Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged.|||units on a scale||Standard Deviation|Mean
2682587|NCT01383317|Secondary|Use of Antiemetics|Number of participants that used an antiemetic postoperative day 1 and postoperative day 2 was recorded.|Postoperative day 1 and postoperative day 2|Data was not collected on some participants in both groups because they were unconscious, refused to answer, or they were discharged.|||Participants|||Count of Participants
2682588|NCT01383317|Secondary|Consumption of Nonopioid Analgesics|All non-opioids analgesics administered during postoperative day 1 and 2 will be recorded and the number of participants that used nonopiods will be given.|Postoperative day 1 and postoperative day 2|Data was not collected on some participants in both groups because they were unconscious, refused to answer or they were discharged.|||Participants|||Count of Participants
2682589|NCT01383317|Secondary|Number of Participants That Consumed Opioids|All opioids administered during postoperative day (POD) 1 and 2 will be recorded and the number of participants that used opioids will be given.|Postoperative day 1 and postoperative day 2|Data was not collected on some participants in both groups because they were unconscious, refused to answer or they were discharged.|||Participants|||Count of Participants
2682590|NCT01383317|Primary|Comparison of Pain Intensity and Unpleasantness Postoperatively|Pain intensity and unpleasantness will be measured on postoperative day (POD) 1 and 2 by using a 0-10 verbal scale after asking the subject to cough. Higher scores denotes more intensity and unpleasantness of pain.|Postoperative day 1 and postoperative day 2|Data was only collected for participants that were alert and conscious.|||units on a scale||Standard Deviation|Mean
2682591|NCT01383213|Secondary|to Compare the Efficacy of the Two Treatments in Terms of In-hospital Mortality|"The secondary endpoint of this study will be evaluated, if appropriate, on 3 subpopulations composed of:~CPAP: patients randomised to CPAP treatment who have changed treatment only after the reaching of the primary endpoint~Control: patients randomised to Venturi mask treatment~Mixed: patients who, after the treatment with Venturi mask, have needed to be treated with non-invasive CPAP"|participants will be followed for the duration of hospital stay, an expected average of 4 weeks|||||||
2682592|NCT01383213|Primary|to Evaluate the Efficacy of CPAP (Group A) in Comparison With Oxygen Therapy With Venturi Mask (Group B, Standard Therapy) in Terms of Achievement of Criteria for Endotracheal Intubation.|"Endotracheale intubation criteria:≥1 among the major criteria or ≥2 among the minor criteria MAJOR CRITERIA:Respiratory arrest;Respiratory pauses with unconsciousness;Severe hemodynamic instability; Need of sedation MINOR CRITERIA:Reduction ≥ 30% of basal PaO2/FiO2; Increasing of 20% PaCO2 if basal PaCO2 is≥40mmHg; Worsening of alertness;Distress;SpO2<90%;Exhaustion.~The reaching of these criteria does not automatically imply the actual intubation of the patient, since this decision will depend on the treating physician."|the reaching of the following endotracheal intubation criteria maintained for at least one hour:||||participants|||Number
2682593|NCT01383200|Primary|Participants Score on Pain Scale|Do you have sharp pain in your eye? Pain will be assessed by units on a scale of 1-5: 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort|1 hour (60minutes) post LASIK operation|Five participants received tetracaine right eye and lidocaine left eye and six participants received lidocaine right eye and tetracaine left eye. A total of 22 eyes were analyzed for pain.|||Score on scale|eyes|Standard Deviation|Mean
2683294|NCT01377467|Other Pre-specified|Percent Change From Baseline in Trabecular Volumetric Bone Mineral Densitiy (Tb.vBMD) at the Distal Radius|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.|||Percent change||95% Confidence Interval|Median
2682594|NCT01383174|Secondary|Breast Cancer-Specific Distress of the Intrusive Thoughts Scale|Breast cancer-specific distress was measured with the 7 item Intrusive Thoughts Scale (anchored to the breast cancer experience), a subscale of the revised Impact of Event Scale (RIES). Response options were 0=not at all, 1=rarely, 2=sometimes, and 3=often. Using the published scoring algorithm, items were summed after recoding responses to 0, 1, 3, and 5. Possible score ranges were 0-35. Higher scores indicate greater distress.|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
2682595|NCT01383174|Secondary|Somatization a Subscale of the Brief Symptom Inventory (BSI)|BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for somatization were 0-4. Higher scores indicated more distress.|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
2682596|NCT01383174|Secondary|Depression a Subscale of the Brief Symptom Inventory (BSI)|BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for depression were 0-4. Higher scores indicated more distress.|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
2682597|NCT01383174|Primary|Total Score of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.~Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to each of the FACT-B subscale. The total overall score is based on the sum of modified subscales (see above primary outcomes for modifications to subscales). Possible score ranges for the total overall score were 0-108. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
2682598|NCT01383174|Primary|Enjoyment of Life a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.~Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: functional well-being subscale. Of 7 items, 3 were dropped because items were conceptually different and did not converge psychometrically with the other items on that scale; the remaining 4 items were specific to enjoyment of life, thus we renamed the subscale to Enjoyment of Life. Modified subscale was scored by summing items. Possible score ranges for enjoyment of life were 0-16. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
2682599|NCT01383174|Primary|Breast Cancer Concerns a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.~Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: breast cancer concerns subscale. Of 7 items, 2 were dropped because of low item-scale correlations and were conceptually different from the other items on that scale. Modified subscale was scored by summing items. Possible score ranges for emotional well-being were 0-28. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
2682600|NCT01383174|Primary|Emotional Well-being a Subscale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.~Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: emotional well-being subscale. Of 6 items, 1 was dropped because of low item-scale correlations and it was conceptually different from the other items on that scale (only positively worded item on the scale). Modified subscale was scored by summing items. Possible score ranges for emotional well-being were 0-20. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
2683295|NCT01377467|Other Pre-specified|Percent Change From Baseline in Cortical Volumetric Bone Mineral Densitiy (Ct.vBMD) at the Distal Radius|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.|||Percent change||95% Confidence Interval|Median
2682601|NCT01383174|Primary|Social/Family Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.~Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: social/family well-being subscale. Of 7 items, 2 were dropped because the items were conditional on having a partner (resulting in lots of missing data). Modified subscale was scored by summing items. Possible score ranges for social/family well-being were 0-20. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
2682602|NCT01383174|Secondary|Anxiety a Subscale of the Brief Symptom Inventory (BSI)|BSI was used to measure general symptoms of distress. BSI consists of 3 scale scores pertaining to general symptoms of distress (anxiety, depression, somatization). Response options were 0=not at all, 1=a little bit, 2=moderately, 3=quite a bit, and 4=extremely. Scores were the mean of nonmissing items. Possible score ranges for anxiety were 0-4. Higher scores indicated more distress.|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
2682603|NCT01383174|Primary|Physical Well-being a Subcale of the Functional Assessment of Cancer Therapy-Breast Quality of Life Instrument (FACT-B)|"FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social-family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much.~Psychometric analysis in our Spanish-speaking Latina sample resulted in modifications to FACT-B: physical well-being subscale. Of 7 items, 1 was dropped because it was conceptually different from other items on that scale. Modified subscale was scored by summing items. Possible score ranges for physical well-being were 0-24. Higher scores indicated greater well-being."|Baseline and 6 month assessment|Using intention-to-treat analyses, used repeated-measures linear regression models to estimate the intervention effects on outcomes. Likelihood-based model estimation assumed outcome responses were missing at random.|||units on a scale||Standard Deviation|Mean
2682604|NCT01383161|Secondary|Change From Baseline to 18 Months on Beck Depression Inventory (BDI)|Beck Depression Inventory is a self-reported questionnaire consisting of 21 items that assess for core depressive symptoms, including sadness, sleep, suicidality, and anhedonia. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total scores range from 0 (no depressive symptoms) to 84 (extreme depression), with higher scores indicating more significant depression.|Baseline and 18 Months||||units on a scale||Standard Deviation|Mean
2682605|NCT01383161|Secondary|Change From Baseline to 18 Months on Trail Making Test, Part A|Trail Making Test is a measure used to assess cognition and attention. Trail Making, Part A is a timed test that consists of 25 circles on a piece of paper with the numbers 1-25 written randomly in circles. The respondent is asked to draw a circle from number one, and so on, in correct numerical order, until they reach number 25. Results are reported as the number of seconds required to complete the task. Respondents were allotted as much time as necessary to complete the task. Higher scores indicate greater impairment.|Baseline and 18 Months||||seconds||Standard Deviation|Mean
2682606|NCT01383161|Primary|Change From Baseline on Buschke Selective Reminding Task, Total Score|Buschke Selective Reminding Task (SRT) is a standardized measure of verbal learning that presents 12 words to the subject who is asked to immediately recall as many words as possible. The examiner then presents words that the subject was unable to recall until the subject can recall all 12 words without prompting twice, or until the examiner has presented prompts up to 12 times. Total Recall score is the sum of words recalled over the 12 trials, which reﬂects immediate recall (short-term memory) for new information. Scores range from 0 to 144, with higher scores indicating better learning.|Baseline and 18 Months||||units on a scale||Standard Deviation|Mean
2682607|NCT01383161|Primary|Change From Baseline on Buschke Selective Reminding Task, Consistent Long-Term Retrieval|Buschke Selective Reminding Task (SRT) is a standardized measure of verbal learning that presents 12 words to the subject who is asked to immediately recall as many words as possible. The examiner then presents words that the subject was unable to recall until the subject can recall all 12 words without prompting twice, or until the examiner has presented prompts up to 12 times. Consistent Long-Term Retrieval score is the number of words that the subject recalls without receiving prompts and indicates how well the subject consolidates the new information during the learning phase (encoding). Scores indicate the sum of consistent long-term word retrieval across the 12 trials and range from 0 to 144, with higher scores indicating better learning.|Baseline and 18 Months||||units on a scale||Standard Deviation|Mean
2682608|NCT01383161|Primary|Change From Baseline to 18 Months on Brief Visual Memory Test-Revised, Delay|The Brief Visual Memory Test-Revised (BVMT-R) provides a measure of visual memory. In three learning trials, the respondent views 6 geometric figures for 10 seconds and is asked to draw as many of the figures as possible from memory in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Delayed recall measures standard scoring of designs for accuracy and correct placement after delay period. Scores range from 0 to 12 and reflect recent, long-term learning, with higher scores indicating better learning. There are 6 equivalent alternate forms.|Baseline and 18 Months||||units on a scale||Standard Deviation|Mean
2682609|NCT01383161|Primary|Change From Baseline to 18 Months on Brief Visual Memory Test-Revised, Recall|The Brief Visual Memory Test-Revised (BVMT-R) provides a measure of visual memory. In three learning trials, the respondent views 6 geometric figures for 10 seconds and is asked to draw as many of the figures as possible from memory in their correct location on a page in the response booklet. A Delayed Recall Trial is administered after a 25-minute delay. Recall measures standard scoring of designs for accuracy and correct placement across the three trials. Scores across the three trials are summed and range from 0 to 36, with higher scores indicating better learning. There are 6 equivalent alternate forms.|Baseline and 18 Months||||units on a scale||Standard Deviation|Mean
2682611|NCT01383096|Primary|OZ439 AUC0-∞|Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)|1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing|Pharmacokinetic Population: all subjects who received study drug, and completed at least one treatment (provided they had adequate OZ439 plasma concentration data) were included in the pharmacokinetic analysis.|||ng.h/mL||Geometric Coefficient of Variation|Geometric Mean
2682612|NCT01383096|Primary|OZ439 Cmax|The maximum observed plasma drug concentrations (Cmax)|1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 168 hours post dosing|Pharmacokinetic Population: all subjects who received study drug, and completed at least one treatment (provided they had adequate OZ439 plasma concentration data) were included in the pharmacokinetic analysis.|||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2682613|NCT01383018|Other Pre-specified|UCLA Prostate Cancer Index Over Five Years|The University of California Los Angeles-Prostate Cancer Index -UCLA-PCI is a validated, twenty question questionnaire to asses impact of treatment for early stage prostate cancer on quality of life. The UCLA-PCI is analyzed in six sections, Sexual Function and Sexual Bother, Urinary Function and Urinary Bother, and Bowel Function and Bowel Bother. This is to measure not just the impact on function but also the quality of life impact. The UCLA PCI domain is scored on a scale of 0-100 points with higher values representing better outcomes.|Baseline through 5 years|Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional.|||score on a scale||Standard Deviation|Mean
2682614|NCT01383018|Other Pre-specified|American Urology Association - Symptom Index Over Five Years|"The AUA-SI contains seven symptoms questions which include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total score of maximum 35 points from non-missing items. The lower score means a better quality of life."|Baseline through 5 years|Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional.|||score on a scale||Standard Deviation|Mean
2682615|NCT01383018|Other Pre-specified|Erection Hardness Scale Over Five Years|The Erection Hardness Scale (EHS), an easy-to-use, four-point scale for erectile dysfunction, provides a reliable measure of erection hardness and an indicator of other health and wellbeing outcomes, according to new data reported at the European Association of Urology. EHS rates the hardness of erection on a scale of zero to four, with four being the maximal score. A higher score indicates a harder penis while a lower score indicates greater dysfunction.|Baseline through 5 years|Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional.|||score on a scale||Standard Deviation|Mean
2682616|NCT01383018|Other Pre-specified|Subject Reported 5-question International Index of Erectile Function (IIEF-5) Total Score, Baseline Through Five Years|Penile prosthesis International Index of Erectile Function (IIEF-5) score (effectiveness objective 2) measured using a validated, multi-dimensional, self-administered questionnaire. Overall responses are reported. A higher score demonstrates an improvement in erectile function while a lower score indicates a loss of erectile function. The 5-question International Index of Erectile Function (IIEF-5) Questionnaire is a validated, multi-dimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes in clinical trials. A score of 0 to 5 is awarded to each of the 5 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. The subscales are summed to calculated the total score. The minimum total score for this questionnaire is 0 with a maximum of 30.|Baseline through 5 years|Number of subjects analyzed reduced over time due to attrition. Also, follow-up after 1 year was optional.|||score on a scale||Standard Deviation|Mean
2682617|NCT01383018|Primary|Number of Participants With Penile Prosthesis That Are Using the Device Less Than Desired or Dissatisfied - Reason Device Used Less Than Desired or Dissatisfied|Reason why subject is using penile prosthesis less than desired or dissatisfied (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.|1 year, post implantation|Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit and responded that they were using the device less than desired or dissatisfied.|||Participants|||Count of Participants
2682618|NCT01383018|Primary|Number of Participants With Penile Prosthesis Using the Device But Not as Often as Desired|Number of penile prosthesis subjects using the device but indicated that they were not using as often as desired (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.|1 year, post implantation|Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit.|||Participants|||Count of Participants
2682619|NCT01383018|Primary|Number of Participants With Penile Prosthesis That Were Not Using the Device, Reasons for Non-use|Penile prosthesis reasons for non-use at 1 year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.|1 year, post implantation|Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit who had answered that they were not using the device and responded to the reason for non-use.|||Participants|||Count of Participants
2682620|NCT01383018|Primary|Number of Times Per Month Participants With Penile Prosthesis Are Using the Device.|Penile prosthesis use at 1 year measured in number of times per month (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.|1 year, post implantation|Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit who hand answered that they were using the device and responded to how many times per month they were using it.|||Number of times per month||Standard Deviation|Mean
2682621|NCT01383018|Primary|Number of Participants With Penile Prosthesis That Are Using the Device Indicating How Often Their Use is.|Penile prosthesis use at year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.|1 year, post implantation|Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit who answered that they were using the device and responded to how often they were using it.|||Participants|||Count of Participants
2682622|NCT01383018|Primary|Number of Participants With Penile Prosthesis That Are Using the Device|Number of subjects using penile prosthesis at 1 year (effectiveness objective 1) measured using a non-validated, standard question, evaluated overall and by penile prosthesis.|1 year, post implantation|Subjects who received an AMS penile prosthesis and completed 1 year follow-up visit.|||Participants|||Count of Participants
2682624|NCT01383005|Secondary|"Percentage of Participants With Missing Doses During the Past 4 Days and the Last Weekend in KAPITAL-2 and QD-KAPITAL Studies"|Adherence to LPV/r QD therapy (overall study population of QD-KAPITAL) compared with that of LPV/r BID therapy using data of Cohort 2 from a 2007-2008 study, respectively (KAPITAL2, Casado et al. See Detailed Description for full reference). The KAPITAL2 cohort was comprised of HIV-infected participants treated with LPV/r BID from ≥3 months to <2 years for at least 1 month before inclusion in the study. (A full comparison of the adherence between the QD-KAPITAL study and the KAPITAL2 study could not be made due to formal differences in the applied adherence questionnaires; therefore, the above in-common specified item was compared.) Data for the overall study population of QD-KAPITAL are provided here, but a comparison to Cohort 2 from the KAPITAL2 study is not presented.|at the single study visit, performed after at least 12 weeks of treatment with Kaletra|All participants with evaluable data.|||percentage of participants|||Number
2682625|NCT01383005|Secondary|Comparison of Mean Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension Scores From QD-KAPITAL and KAPITAL2 Studies|Participants' perceptions of the QD and BID LPV/r regimens using data from the overall study population of QD-KAPITAL and from Cohort 2 of a 2007-2008 study, respectively (KAPITAL2, Casado et al. See Detailed Description for full reference). The KAPITAL2 cohort was comprised of HIV-infected participants treated with LPV/r BID from ≥3 months to <2 years for at least 1 month before inclusion in the study. Data for the overall study population of QD-KAPITAL are provided here, but a comparison to Cohort 2 from the KAPITAL2 study is not presented.|at the single study visit, performed after at least 12 weeks of treatment with Kaletra|All participants with evaluable data. n=the number of participants with data for given dimension.|||units on a scale||Standard Deviation|Mean
2682626|NCT01383005|Secondary|Mean Number of Days on LPV/r QD|This independent variable was correlated with the percentage of participants with the dependent variable of an HIVTSQ Overall Satisfaction dimension mean score value of <5 (see Outcome Measure 8), to determine the factors associated with a participant's lower perception of QD LPV/r treatment (see statistical analysis for odds ratio).|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants, per responses to the HIVTSQ Overall Satisfaction Dimension|||days||Standard Deviation|Mean
2682627|NCT01383005|Secondary|Viral Load (VL) Change After at Least 12 Weeks of Treatment With the Lopinavir/Ritonavir (LPV/r)|Viral load change was categorized as either 'detectable to undetectable,' 'undetectable to undetectable,' or 'current detectable' (includes participants whose viral load changed from undetectable to detectable and those whose viral load was detectable throughout). This independent variable was correlated with the percentage of participants with the dependent variable of a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction dimension mean score value of <5 (see Outcome Measure 8), to determine the factors associated with a participant's lower perception of QD LPV/r treatment (see statistical analyses for odds ratio).|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants, per responses to the HIVTSQ Overall Satisfaction Dimension|||participants|||Number
2682628|NCT01383005|Secondary|Percentage of Participants With a Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Overall Satisfaction Dimension Mean Score Value of ≥5 and <5|The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The items are aggregated to 3 different dimensions. The Overall Satisfaction dimension has a maximum score of 54 (items 1, 2, 3, 5, 6, 7, 8, 9 and 10). The mean of the individual item scores were dichotomized as 'mean score <5 (lower participant perception of LPV/r QD)' and 'mean score ≥5 (high or very high participant perception of LPV/r QD).' The dependent variable of a mean score <5 was correlated with the independent variables of viral load and time on treatment (see Outcome Measures 9 and 10), to determine the factors associated with a participant's lower perception of QD LPV/r treatment.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants|||percentage of participants|||Number
2682629|NCT01383005|Secondary|Reasons for Starting or Switching to a Lopinavir/Ritonavir Once Daily (LPV/r QD)Regimen|Participants' cumulative reasons for starting or switching to a LPV/r QD regimen were tabulated via the following yes/no questions entered on the case report form by the physician: simplification (simp) as reason to change to LPV/r QD; preference (pref) of patient as reason to change to LPV/r QD; adjustment to other antiretrovirals (adjust to ARV) as reason to change to LPV/r QD; adherence as reason to change to LPV/r QD; patient's lifestyle as reason to change to LPV/r QD; tolerability as reason to change to LPV/r QD.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants|||participants|||Number
2682630|NCT01383005|Secondary|Adherence Classification of Participants Per Simplified Medication Adherence Questionnaire (SMAQ)|Participants' adherence was classified according to answers for 5 of 6 items on the participant questionnaire Simplified Medication Adherence Questionnaire (SMAQ): 4 yes/no questions: Do you ever forget to take your medicines? Do you take your medicines at the instructed time? If you ever feel ill, do you stop taking the medication? Have you ever missed your medication during weekends?; plus the following: In the past week, how many times have you missed your medication? (0, 1-2, 3-5, 6-10, >10). (Please see Outcome Measure 5 for details regarding the 6th item on the SMAQ.) Perfect adherence = no dose was forgotten, medication was not skipped for any reason, and the schedule was not modified; adequate adherence = no dose was forgotten, but at least one dose was not taken at the indicated time; poor adherence = one or more doses were not taken.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data.|||participants|||Number
2682631|NCT01383005|Secondary|Number of Days Without Medication, Per Simplified Medication Adherence Questionnaire (SMAQ)|Number of days without medication was assessed by 1 of the 6 items on the patient questionnaire Simplified Medication Adherence Questionnaire (SMAQ): How many full days have you missed your medication since your last visit? (Please see Outcome Measure 6 for details regarding the remaining 5 items on the SMAQ.)|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data.|||participants|||Number
2684390|NCT01368497|Secondary|Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
2682632|NCT01383005|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores Comparison Between Cohorts|The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The items are aggregated to 3 different dimensions: the Overall Satisfaction dimension, with a maximum score of 54 (items 1, 2, 3, 5, 6, 7, 8, 9 and 10); General/Clinical Satisfaction dimension, with a maximum score of 30 (items 1, 2, 3, 9 and 10); Lifestyle dimension, with a maximum score of 24 (items 5, 6, 7 and 8). The mean score per dimension was compared between cohorts.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data. n=number of participants with complete data for given HIVTSQ item.|||units on a scale||Standard Deviation|Mean
2682633|NCT01383005|Primary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ)Dimension (Overall Satisfaction, General/Clinical Satisfaction, Lifestyle) Scores for the Overall Study Population|The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The items are aggregated to 3 different dimensions: the Overall Satisfaction dimension, with a maximum score of 54 (items 1, 2, 3, 5, 6, 7, 8, 9 and 10); General/Clinical Satisfaction dimension, with a maximum score of 30 (items 1, 2, 3, 9 and 10); Lifestyle dimension, with a maximum score of 24 (items 5, 6, 7 and 8). Each dimension was considered for the evaluation of the primary outcome. For each participant, each dimension score was calculated as a sum of the individual item scores.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data. n=number of participants with complete data for given HIVTSQ item.|||units on a scale||Standard Deviation|Mean
2682634|NCT01383005|Secondary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores Comparison Between Cohorts|The HIVTSQ consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The mean score per item was compared between cohorts.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data. n=number of participants with complete data for given HIVTSQ item.|||units on a scale||Standard Deviation|Mean
2682635|NCT01383005|Primary|Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Individual Item Scores for the Overall Study Population|Participant treatment satisfaction was measured using the HIVTSQ, which consists of 10 items (1-Satisfaction, 2-HIV Control, 3-Adverse Effects, 4-Level of Demand, 5-Convenience, 6-Flexibility, 7-Knowledge, 8-Life Habits, 9-Recommendability, and 10-Willingness to Continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). Each single item was considered for the evaluation of the primary outcome.|At the single study visit, performed after at least 12 weeks of treatment with Kaletra QD|All participants with complete data. n=number of participants with complete data for given HIVTSQ item.|||units on a scale||Standard Deviation|Mean
2682636|NCT01382940|Secondary|Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Third Rituximab Infusion|"Participants who experienced a moderate or serious IRR had their infusion interrupted immediately and received aggressive symptomatic treatment. The CTCAE includes the following severity descriptions: - Moderate means mild to moderate interference with the patient's daily activities, no or minimal medical intervention/therapy required; - Severe means considerable interference with the patient's daily activities, medical intervention/therapy required, hospitalization possible. If the IRR was moderate, the infusion was not to be restarted before all the symptoms disappeared, and then at half the rate. If the participant tolerated the reduced rate for 30 minutes, the infusion rate was increased to the next rate on the protocol-specified infusion schedule. If the symptoms did not resolve with treatment, the participant was withdrawn from the treatment period of the study. Participants who experienced a severe IRR to rituximab treatment were discontinued from the study."|During the infusion (a 2-hour period) on Day 168|All randomized participants who received infusion at the faster rate on Day 168. One participant received the Day 168 rituximab infusion at the labeled rate rather than at the faster rate and was excluded from the analysis population.|||percentage of participants||95% Confidence Interval|Number
2682637|NCT01382940|Secondary|Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Third Rituximab Infusion|"The intensity of AEs experienced within 24 hours of beginning infusion were graded on NCI's CTCAE (v. 4.0) intensity scale from Grade 1 (Mild) to Grade 5 (Death). Grade 3 AEs are Severe and Grade 4 AEs are Life-threatening, Disabling."|Within 24 hours of beginning infusion on Day 168|All randomized participants who received infusion at the faster rate on Day 168. One participant received the Day 168 rituximab infusion at the labeled rate rather than at the faster rate and was excluded from the analysis population.|||percentage of participants||95% Confidence Interval|Number
2682647|NCT01382719|Secondary|Desire Domain From Female Sexual Function Index|The FSFI is brief self-report questionnaire that measures female sexual function. The change from baseline to end of study in the desire domain were obtained from the FSFI Q1 and Q2. The score range is 1-5. For each of the 2 time points, the score was computed programmatically using the algorithm described by Rosen [6], resulting in a score from 0 (min) to 6 (max).|4-12 weeks from baseline to end of study (total study duration 20 weeks)||||units on a scale||Standard Deviation|Mean
2682648|NCT01382719|Secondary|Satisfaction With Arousal as Measured by GAQ Question 1|"This is the change in Baseline to End-of-Study in Satisfaction with Arousal as measured by GAQ Question 1. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 1 is Compared to the start of the study (prior to taking the study drug), how would you describe your satisfaction with your arousal while using the study drug? The score range is 1 (very much worse) to 7 (very much better)."|4-12 weeks from baseline to end of study (total study duration 20 weeks)||||units on a scale||Standard Deviation|Mean
2682638|NCT01382940|Secondary|Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Second Rituximab Infusion|"Participants who experienced a moderate or serious IRR had their infusion interrupted immediately and received aggressive symptomatic treatment. The CTCAE includes the following severity descriptions: - Moderate means mild to moderate interference with the patient's daily activities, no or minimal medical intervention/therapy required; - Severe means considerable interference with the patient's daily activities, medical intervention/therapy required, hospitalization possible. If the IRR was moderate, the infusion was not to be restarted before all the symptoms disappeared, and then at half the rate. If the participant tolerated the reduced rate for 30 minutes, the infusion rate was increased to the next rate on the protocol-specified infusion schedule. If the symptoms did not resolve with treatment, the participant was withdrawn from the treatment period of the study. Participants who experienced a severe IRR to rituximab treatment were discontinued from the study."|During the infusion (a 2-hour period) on Day 15|All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined.|||percentage of participants||95% Confidence Interval|Number
2682639|NCT01382940|Secondary|Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Second Rituximab Infusion|"The intensity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0), where Grade 1 indicates Mild severity and Grade 5 indicates Death. The CTCAE defines Grades 3 and 4 as follows: - Grade 3 means Severe, indicating considerable interference with the patient's daily activities; medical intervention/therapy required; and hospitalization possible. - Grade 4 means Life-threatening, Disabling, based on extreme limitation in activity; significant medical intervention/therapy required, and hospitalization probable."|Within 24 hours of beginning infusion on Day 15|All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined.|||percentage of participants||95% Confidence Interval|Number
2682640|NCT01382940|Secondary|Percentage of Participants Experiencing Any IRR or SIRR Associated With the Third Rituximab Infusion|IRRs are AEs that occurred within 24 hours of beginning infusion that were included on a pre-specified list of MedDRA preferred terms, and an SIRR is an IRR that suggests a significant hazard, contraindication, side effect or precaution.|Within 24 hours of beginning infusion on Day 168|All randomized participants who received infusion at the faster rate on Day 168. One participant received the Day 168 rituximab infusion at the labeled rate rather than at the faster rate and was excluded from the analysis population.|||percentage of participants||95% Confidence Interval|Number
2682641|NCT01382940|Secondary|Percentage of Participants Experiencing Any Serious IRR (SIRR) Associated With the Second Rituximab Infusion|A serious infusion-related reaction (SIRR) is an IRR that meets the definition of a serious adverse event. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution.|Within 24 hours of beginning infusion on Day 15|All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined.|||percentage of participants||95% Confidence Interval|Number
2682642|NCT01382940|Primary|Percentage of Participants Experiencing Any Infusion-related Reaction (IRR) Associated With the Second Rituximab Infusion|"The primary criterion for assessing safety of the faster infusion was the incidence of infusion related reaction (IRRs). IRRs were adverse events (AEs) that occurred within 24 hours of beginning infusion that were among a pre-specified list of preferred terms from the Medical Dictionary for Regulatory Activities (MedDRA). Incidence is defined as the percentage of participants experiencing an IRR."|Within 24 hours of beginning infusion on Day 15|All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined.|||percentage of participants||95% Confidence Interval|Number
2682643|NCT01382901|Primary|International Restless Legs Syndrome (IRLS) Total Score|The scale represents the patients symptoms of RLS. The patient rates his/her symptoms based on 10 questions with a maximum possible score of 40 representing the most severe symptoms while a score of 0 represents no symptoms at all.|Change from Baseline to Day 28|Evaluable Population|||Scores on a scale||Standard Deviation|Mean
2682644|NCT01382719|Secondary|FSDS-DAO Total Score|"FSDS-DAO (Female Sexual Distress Scale - Desire/Arousal/Orgasm) is an assessment tool to measure female sexual distress. The change from baseline to end of study in the FSDS-DAO (total score) was measured. There are 15 questions, eg, How often do you feel: Distressed about your sex life and the score range was 0 (Never), 1 (Rarely), 2 (Occasionally), 3 (Frequently), 4 (Always). The score for each subject at each time point was computed as the sum of the scores from the 15 questions, resulting in a possible score at each time point between 0 and 60."|4 - 12 weeks from baseline to end of study (total study duration 20 weeks)||||units on a scale||Standard Deviation|Mean
2682645|NCT01382719|Secondary|Quality of Relationship With Partner as Measured by GAQ Question 4|"This is the change in Baseline to End-of-Study in Quality of Relationship with Partner as Measured by GAQ Question 4. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 4 is Compared to the start of the study (prior to taking the study drug), how has taking the study drug changed your relationship with your partner? The score range is 1 (very much worse) to 7 (very much better)."|4-12 weeks from baseline to end of study (total study duration 20 weeks)||||units on a scale||Standard Deviation|Mean
2682646|NCT01382719|Secondary|Satisfaction With Desire as Measured by GAQ Question 2|"This is the change in Baseline to End-of-Study in Satisfaction with Desire as Measured by GAQ Question 2. GAQ (Global Assessment Questions) is a questionnaire that evaluates overall satisfaction level experienced while using the study drug. Question 2 is Compared to the start of the study (prior to taking the study drug), how would you describe your satisfaction with your desire while using the study drug? The score range is 1 (very much worse) to 7 (very much better)."|4-12 weeks from baseline to end of study (total study duration 20 weeks)||||units on a scale||Standard Deviation|Mean
2684391|NCT01368497|Secondary|Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
2682649|NCT01382719|Secondary|Change From Baseline to End-of-Study in Arousal Domain Score From Female Sexual Function Index|The FSFI is brief self-report questionnaire that measures female sexual function. The change from baseline to end of study in the arousal domain were obtained from the FSFI Q3 through Q6. The score range is 0-5. For each of the 2 time points, the score was computed programmatically using the algorithm described by Rosen [6], resulting in a score from 0 (min) to 6 (max).|4-12 weeks from baseline to end of study (total study duration 20 weeks)||||units on a scale||Standard Deviation|Mean
2682650|NCT01382719|Primary|The Primary Efficacy Endpoint is Change From Baseline to End of Study in the Number of Satisfying Sexual Events (SSE)|"The primary efficacy endpoint is change from baseline to end of study in the number of satisfying sexual events (SSEs), computed as the number of events during the last 4 weeks of treatment with FSEP-R Q10 = Yes minus the number of baseline events with FSEP-R Q10 = Yes. Efficacy analyses were done with the MITT population which consisted of all randomized subjects who took at least 1 dose of double-blind treatment after the 2 in-clinic doses of double-blind medication and who had at least 1 follow-up visit (Visit 10 or later) to ensure that FSEP-R data were reviewed and confirmed by the investigative site."|4 - 12 weeks from baseline to end of study (total study duration 20 weeks). Baseline was the 4-week single-blind placebo period.||||SSEs||Standard Deviation|Mean
2682651|NCT01382602|Primary|Percentage of Participants With Response (Based on Stress IEF, or In-office Pad Weight Test, or 24-hour Pad Weight Test) at 12 Months|A composite primary endpoint of responder rate was used, where a subject was considered a responder if she had ≥ 50% reduction from baseline in stress Incontinence Episode Frequency (stress IEF; reported stress leaks from 3-day diary) or ≥ 50% reduction in leakage from baseline as determined by either the in-office pad weight test or the 24-hour pad weight test.|12 months|Analysis population is based on subjects that received at least 1 treatment of AMDC-USR or placebo at the 12 months follow-up..|||Percentage of subjects||95% Confidence Interval|Number
2682652|NCT01382446|Primary|Effectiveness of Chlorhexidine Gluconate Oral Care for Trauma Patients|Examination of number of participants who do not develop oral bacteria and Ventilator Associated Pneumonia when an oral rinse containing 0.12% Chlorhexidine Gluconate is used as part of a oral care protocol.|18 Months|Intention to Treat Analysis Used|||participants|||Number
2682653|NCT01382303|Secondary|Mean Change of TNF-a|changes in TNF-a from baseline to 24 weeks|baseline and 24 weeks||||pg/mL||Standard Deviation|Mean
2682654|NCT01382303|Secondary|Mean Change of Fasting Glucose|changes serum fasting glucose from baseline to 24 weeks|baseline and 24 weeks||||mg/dL||Standard Deviation|Mean
2682655|NCT01382303|Secondary|Mean Change of Creatinine|changes serum creatinine from baseline to 24 weeks|baseline and 24 weeks||||mg/dL||Standard Deviation|Mean
2682656|NCT01382303|Secondary|Mean Change of eGFR|changes in eGFR from baseline to 24 weeks|baseline and 24 weeks||||ml/min per 1.73m2||Standard Deviation|Mean
2682657|NCT01382303|Secondary|Percentage Change in Albuminuria|Changes of urine albumin to creatinie ratio from baseline to 24 weeks|baseline and 24 weeks||||% change from baseline||Inter-Quartile Range|Mean
2682658|NCT01382303|Primary|Percentage Change in Proteinuia|Changes of urine protein to creatinie ratio from baseline to 24 weeks|baseline and 24 weeks||||% change from baseline||Inter-Quartile Range|Mean
2682659|NCT01382251|Secondary|Brief Pain Inventory (BPI) Functional Interference Score.|"Comprised of seven questions in which the subject is asked to describe the extent to which pain interferes with activity. Scores are anchored at 0 for does not interfere and 10 for completely interferes. The seven resulting scores are averaged and reported as a single value (0 - 10) with higher scores indicating greater interference with function."|Baseline, one week, and one month following surgery||||units on a scale||Standard Deviation|Mean
2682660|NCT01382251|Secondary|Short Form 12|A validated measure of health related quality of life comprised of 12 questions regarding participant experience over the preceding week. Generate Physical And Mental Component scores ranging from 0-100 with higher scores indicating better quality of life.|Baseline, one week, and one month following surgery||||units on a scale||Standard Deviation|Mean
2682661|NCT01382251|Secondary|Zarit Burden Interview (ZBI)|"A 22-item questionnaire in which subjects rate how often they experience negative feelings associated with caregiving. Each item rated on a 5 point scale anchored at 0 for never and 4 for nearly always. Scores range from 0-88 with higher scores indicating increased burden of care."|Baseline, one week, and one month following surgery||||units on a scale||Standard Deviation|Mean
2682662|NCT01382251|Primary|Functional Autonomy Measurement System (SMAF)|29-item scale, each item graded on a four-point scale. 0= independent, 1= needs supervision,2 = needs help, 3 = dependent. Total score ranges from 0 to 87 with higher scores indicating increased disability|Baseline, one week, and one month following surgery||||units on a scale||Standard Deviation|Mean
2682663|NCT01382225|Secondary|Proportion of Improved Scores on the Global Impact on Dry Eye Syndrome on Daily Life (GIDL) Rating|"The subject was asked on a questionnaire, Please consider how your dry eyes feel when doing daily activities such as working on the computer, watching television, reading, and driving. Based on this, please rate the impact of your dry eye symptoms on your daily life, and responded on a 4-point scale from 0-3 (0=Absent to 3=Severe). Improved was defined as a change in score of <0 from baseline. Proportion is reported as a percentage of participants. A greater percentage of subjects reporting a lower score indicates an improvement."|Baseline, Up to Day 14|Modified Intent-to-Treat|||Percentage of Participants|||Number
2682664|NCT01382225|Secondary|Percentage Change From Baseline in Global Symptom Composite Index (GSCI) Score|For each of 5 common dry eye symptoms, the frequency (0-3) and intensity (0-100) scores were multiplied to obtain the symptom score (0-300). The 5 symptom scores were summed to obtain the Global Symptom Composite Index Score (0-1500). A more negative percentage change indicates a greater amount of improvement.|Baseline, up to Day 14|Modified Intent-to-Treat|||Percentage change||Standard Deviation|Mean
2682665|NCT01382225|Secondary|Percentage Change From Baseline in Global Symptom Intensity (GSI) Total Score|The subject completed a questionnaire and rated the intensity of five common dry eye symptoms. Intensity was rated on a visual analog scale from 0-100 (0=no symptoms to 100=severe symptoms). The GSI Total Score (0 to 500) is the sum of the five individual ratings. A more negative percentage change indicates a greater amount of improvement.|Baseline, up to Day 14|Modified Intent-to-Treat|||Percent change||Standard Deviation|Mean
2684423|NCT01368185|Primary|Serum Uric Acid (SUA) Level|SUA at baseline and Month 3.|Baseline and Month 3||||mg/dL||Standard Deviation|Mean
2682667|NCT01382225|Secondary|Percentage Change From Baseline in Corneal Fluorescein Staining (CFS) Total Score|The investigator instilled an ophthalmic dye on the eye and rated corneal staining by type, extent/surface area, and depth. Each staining was rated on a 5-point scale from 0 to 4 (0=no staining/0% to 4=patch/>45%/immediate diffuse stromal glow). The CFS Total Score (0-12) is the sum of the three individual ratings. A more negative percentage change indicates a greater amount of improvement.|Baseline, up to Day 14|Modified Intent-to-Treat|||Percent change||Standard Deviation|Mean
2682668|NCT01382225|Secondary|Change From Baseline in GSF Total Score at Day 14|The subject completed a questionnaire and rated the frequency of five common dry eye symptoms. Frequency was rated on a 4-point scale from 0 to 3 (0=never to 3=constantly). The GSF Total Score (0-15) is the sum of the five individual ratings. A more negative change indicates a greater amount of improvement.|Baseline, Day 14|Modified Intent-to-Treat|||Units on a scale||Standard Deviation|Mean
2682669|NCT01382225|Secondary|Change From Baseline in LGS Total Score at Day 14|The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement.|Baseline, Day 14|Modified Intent-to-Treat|||Units on a scale||Standard Deviation|Mean
2682670|NCT01382225|Primary|Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7|The subject completed a questionnaire and rated the frequency of five common dry eye symptoms. Frequency was rated on a 4-point scale from 0 to 3 (0=never to 3=constantly). The GSF Total Score (0-15) is the sum of the five individual ratings. A more negative change indicates a greater amount of improvement.|Baseline, Day 7|Modified Intent-to-Treat|||Units on a scale||Standard Deviation|Mean
2682671|NCT01382225|Primary|Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7|The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement.|Baseline, Day 7|Modified Intent-to-Treat (mITT): The set of all randomized subjects who received at least one administration of the allocated product, had baseline efficacy measurement, had at least 1 post-baseline measurement and received the correct formulation of the lissamine green solution.|||Units on a scale||Standard Deviation|Mean
2682672|NCT01382212|Secondary|Number of Subjects With Potentially Clinically Significant Physical Examination Findings||Baseline (Day 1) and Final Visit (up to Week 12)|All-treated data set|||participants|||Number
2682673|NCT01382212|Secondary|Oral Body Temperature: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set|||degrees Celsius||Standard Deviation|Mean
2682674|NCT01382212|Secondary|Heart Rate: Mean Change From Baseline to Final Visit|Heart rate was measured after the subject had been sitting for at least 3 minutes.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set|||bpm||Standard Deviation|Mean
2682675|NCT01382212|Secondary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit|Blood pressure was measured after the subject had been sitting for at least 3 minutes.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set|||mm Hg||Standard Deviation|Mean
2682676|NCT01382212|Secondary|Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings|12-lead ECGs were recorded after the subject had been in the supine position for at least 5 minutes. The number of subjects with potentially clinically significant ECG findings, as determined by the investigator, is presented.|Baseline (Day 1) to Final Visit (up to Week 12)|All-treated data set|||participants|||Number
2682677|NCT01382212|Secondary|Number of Subjects With Adverse Events|An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.|From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks).|All-treated data set|||participants|||Number
2682678|NCT01382212|Secondary|Osteocalcin: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||ng/mL||Standard Deviation|Mean
2682679|NCT01382212|Secondary|Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit|n=subjects with evaluable Baseline and Post-baseline data for each parameter.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set|||pg/mL||Standard Deviation|Mean
2682680|NCT01382212|Secondary|Total Protein and Albumin: Mean Change From Baseline to Final Visit|n=subjects with evaluable Baseline and Post-baseline data for each parameter.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All-treated data set|||g/dL||Standard Deviation|Mean
2682681|NCT01382212|Secondary|Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||mEq/L||Standard Deviation|Mean
2682682|NCT01382212|Secondary|Alkaline Phosphatase: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||IU/L||Standard Deviation|Mean
2685988|NCT01353963|Primary|Change From Baseline in Heart Rate at Week 4.||Week 4|Safety population included all participants who received at least 1 dose of study medication during the observation period.|||beats per minute (bpm)||Standard Deviation|Mean
2682683|NCT01382212|Secondary|Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit|n=subjects with evaluable Baseline and Post-baseline data for each parameter.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||mg/dL||Standard Deviation|Mean
2682684|NCT01382212|Secondary|Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit|n=subjects with evaluable Baseline and Post-baseline data for each parameter.|Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||U/L||Standard Deviation|Mean
2682685|NCT01382212|Secondary|Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||cells x 10^9/µL||Standard Deviation|Mean
2682686|NCT01382212|Secondary|White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||cells x 10^3/µL||Standard Deviation|Mean
2682687|NCT01382212|Secondary|Red Blood Cells: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||cells x 10^6/µL||Standard Deviation|Mean
2682688|NCT01382212|Secondary|Hematocrit: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||percent||Standard Deviation|Mean
2682689|NCT01382212|Secondary|Hemoglobin: Mean Change From Baseline to Final Visit||Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)|All subjects in the all-treated data set with evaluable data|||g/dL||Standard Deviation|Mean
2682690|NCT01382212|Secondary|Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline||Baseline (last measurement collected prior to the first dose) to Week 12|All-treated data set|||percentage of participants||95% Confidence Interval|Number
2682691|NCT01382212|Secondary|Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL||Baseline (last measurement collected prior to the first dose) to Week 12|All-treated data set|||percentage of participants||95% Confidence Interval|Number
2682692|NCT01382212|Primary|Percentage of Subjects With Hypercalcemia|The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values > 10.2 mg/dL (2.55 mmol/L).|Day 1 to Week 12|All-treated data set: all subjects enrolled and administered at least 1 dose of paricalcitol|||percentage of participants||95% Confidence Interval|Number
2682693|NCT01382186|Primary|Veteran Need for Education Support for My HealtheVet and Secure Messaging Use.|Veterans were asked to report if they would like to have education and support using My HealtheVet and the Secure Messaging tool.|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.|||participant|||Number
2682694|NCT01382186|Primary|Veterans That Believed Improvements to the Secure Messaging System Would Make the Tool More Useful in the Future Are Presented in the Table.|Veterans were asked to report if improvements to the secure messaging system would make the tool more useful for use in the future.|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.|||participant|||Number
2682695|NCT01382186|Primary|Intention to Use Secure Messaging in the Future|Veteran respondent intention to use Secure Messaging in the future|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.|||participant|||Number
2682696|NCT01382186|Primary|Benefits of Using Secure Messaging|Veterans report benefits of using Secure Messaging|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.|||participant|||Number
2682697|NCT01382186|Primary|Reasons for Using Secure Messaging Tool on My HealtheVet|Participants reported reasons for Using Secure Messaging tool on My HealtheVet|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans registered for My HealtheVet and opted in to use Secure Messaging. The sample of 33 Veterans from phase 1 was not included in this method of the study.|||participant|||Number
2682698|NCT01382186|Primary|Frequency of Electronic Resource Use|Mail surveys examine Veterans frequency of electronic resource use.|baseline|This is a primary outcome for phase 2 of the study which was measured in random sample of 819 Veterans. The purposive sample of 33 Veterans from phase 1 was not included in this method of the study.|||participants|||Number
2682699|NCT01382186|Primary|Secure Messaging Use and Content Patterns|Extraction of secure messages over a three-month time frame to examine message content type, including: general, tests, medication, and appointments.|3 months|This method of secondary data collection was conducted with the purposive sample of 33 Veterans in phase 1 of the study. The random sample of 819 Veteran survey respondents in phase 2 were not included in this method of data collection.|||secure messages|Participants||Number
2682712|NCT01381900|Secondary|Percent Change in Body Weight From Baseline to Week 18|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.|||Pecent change||Standard Error|Least Squares Mean
2682700|NCT01382186|Primary|Usability of Secure Messaging|To determine ease of use and usefulness of secure messaging. Purposive sample of 33 participants were assessed for their ability to complete the following tasks: navigate to Secure Messaging, log-in to My HealtheVet and Secure Messaging, Set user preferences, check Secure Message inbox, open and send Secure Message, Open and read Secure Message attachment. Measured as: (1) able to complete task; (2) able to complete task with some difficulty; (3) not able to complete task.|baseline|This user-testing method was conducted with the first purposive sample of 33 participants in phase 1 of the study. The random sample of 819 participants in phase 2 were not a part of the user-testing study method.|||participants|||Number
2682701|NCT01382108|Primary|Tear Meniscus Height (TMH). The Height of the Tear Film Meniscus at the Eyelid Margin.|Assessments will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.|Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.||||mm||Standard Deviation|Mean
2682702|NCT01382108|Primary|Tear Breakup Time (TBUT). The Time Taken, in Seconds, for the Tear Film to Break up on the Surface of the Cornea.|Measurements will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.|Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.||||seconds||Standard Deviation|Mean
2682703|NCT01382108|Primary|Meibomium Gland Dropout Score - Evidence of Meibomian Gland Dysfunction (MGD) Confirmed by Meibograhpy Imaging Using the Keratograph 4 Measured on a Subjective Grading Scale (0-3) (Summing the Score for the Upper and Lower Lids for a Final Scale of 0-6)|"Assessments will be made in normal participants (no MGD) and participants with MGD and compared between the two groups at baseline and after the use of a meibomian gland evaluator.~The meibomium gland dropout score subjective grading scale:~0 = no loss of mebomium glands~= area of meibomium gland loss less than 33%~= area of meibomium gland loss between 33% and 67%~= area of meibomium gland loss more than 67%."|Before and after the use of a meibomian gland evaluator. Assessments will be separated by a period of at least 10 minutes.||||units on a scale||Standard Deviation|Mean
2682704|NCT01381952|Other Pre-specified|Radiation Dose Measurements: Air Kerma (AK)|Percentage of dose reduction of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame.|Participants were followed for the duration of the procedure|All patients with recorded dose information and images for both angiograms were included (n=20)|||percentage of dose reduction||Standard Deviation|Mean
2682705|NCT01381952|Secondary|Radiation Dose Measurements: Dose Area Product (DAP)|Percentage of dose reduction of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame.|Participants were followed for the duration of the procedure|All patients with recorded dose information and images for both angiograms were included (n=20)|||percentage of dose reduction||Standard Deviation|Mean
2682706|NCT01381952|Primary|Image Quality. For Each Included Participant 2 Images (1 AlluraXper; 1 AlluraClarity) Were Evaluated.|"The images were evaluated in randomized, blinded, offline readings. The anonymized images were displayed in pairs, i.e. the reference image run on one monitor (randomly left or right side) with the corresponding quarter-dose image run on the adjacent monitor. Three neuroradiologists graded the arterial, capillary, and venous phases separately. For each characteristic the images quality (IQ) were rated on a scale of 1 to 5 as 1 (very poor), 2 (mediocre), 3 (average), 4 (good), 5 (very good/excellent). An overall IQ score (3-15) was calculated as the sum of the score for these characteristics.~A paired Student's t test is used to compare the overall IQ score between the 2 imaging techniques. If the upper limit of the 97.5% one-sided CI for the difference overall IQ between the two treatment groups does not exceed the pre-defined non-inferiority margin of 2.5 Clarity will be declared non-inferior to the current image acquisition settings for DSA."|1 day||||Scores on a scale||95% Confidence Interval|Mean
2682707|NCT01381926|Primary|Determine Changes in Bone Turnover Markers by Tartrate-Resistant Acid Phosphatase 5b (TRACP5b) During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM.|Bone turnover by Tartrate-Resistant Acid Phosphatase 5b (TRACP5b) was assessed. Distribution of the Difference between EX/PBO Low/High Dose and Baseline Levels were calculated.|Baseline to 20 weeks|For Crossover, study, participants were matched for the placebo and study drug arms. As such, only data from participants completing both arms were included in the statistical analysis.|||U/L||Standard Deviation|Mean
2682708|NCT01381926|Primary|Determine Changes in Bone Turnover Markers by Serum N-Telo Peptide During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM.|Bone turnover by Serum N-Telo peptide (NTX) was assessed. Distribution of the Difference between EX/PBO Low/High Dose and Baseline Levels were calculated|Baseline to 20 weeks|For Crossover, study, participants were matched for the placebo and study drug arms. As such, only data from participants completing both arms were included in the statistical analysis.|||nMBCE/L||Standard Deviation|Mean
2682709|NCT01381926|Primary|Determine Changes in Bone Resorption Markers During the Treatment With a GLP-1 Receptor Agonist (Exenatide) Compared to Placebo in Patients With T2DM.|Bone reabsorption by bone-specific alkaline phosphatase (BAP) was assessed. Distribution of the Difference between EX/PBO Low/High Dose and Baseline Levels were calculated.|Baseline to 20 weeks|For Crossover study, participants were matched for the placebo and study drug arms. As such, only data from participants completing both arms were included in the statistical analysis.|||mg/L||Standard Deviation|Mean
2682710|NCT01381900|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <6.5% at Week 18|The table below shows the percentage of patients with HbA1c <6.5% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.|||Percentage of patients|||Number
2682711|NCT01381900|Secondary|Percentage of Patients With Glycosylated Hemoglobin (HbA1c) <7% at Week 18|The table below shows the percentage of patients with HbA1c <7% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.|||Percentage of patients|||Number
2682713|NCT01381900|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
2682714|NCT01381900|Primary|Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 18|The table below shows the least-squares (LS) mean change in HbA1c from baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 18|Analysis used overall mITT analysis set (all randomized patients who received at least 1 dose of double-blind study drug). Last-observation-carried-forward method used for missing Week 18 values. Table includes only participants with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
2682715|NCT01381874|Secondary|Change From Baseline in Serum Endocrine Biomarkers (Progesterone and Testosterone) at End of Treatment|Change from baseline in serum endocrine biomarkers (Progesterone and Testosterone) was summarized by treatment at end of treatment.|Baseline and End of treatment (approximately 2 years)|"ITT analysis set with valid baseline value and at least 1 post baseline value. Here n (number analyzed) signifies participants evaluable for specified categories."|||Nanomoles Per Liter (nmol/L)||Standard Deviation|Mean
2682716|NCT01381874|Secondary|Change From Baseline in Serum Endocrine Biomarkers (Estradiol and Estrone) at End of Treatment|Change from baseline in serum endocrine biomarkers (estradiol and estrone) was summarized by treatment at end of treatment.|Baseline and End of treatment (approximately 2 years)|"ITT analysis set with valid baseline value and at least 1 post baseline value. Here n (number analyzed) signifies participants evaluable for specified categories."|||Picomoles Per Liter (Pmol/L)||Standard Deviation|Mean
2682717|NCT01381874|Secondary|Duration of Response|Duration of objective response was measured from the first time that the CR or PR was achieved to the first observation of disease progression (either radiographic or clinical) based on the RECIST criteria.|Approximately 2 years|ITT analysis set with measurable disease at baseline with complete or partial response.|||months||95% Confidence Interval|Median
2682718|NCT01381874|Secondary|Clinical Benefit Rate|Clinical benefit rate was defined as the percentage of participants with measurable disease achieving a best overall response of a CR, PR, or stable disease (SD) for at least 6 months based on RECIST. Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits.|Approximately 2 years|ITT analysis set with measurable disease at baseline.|||Percentage of participants|||Number
2682719|NCT01381874|Secondary|Overall Response Rate (ORR)|Overall response rate was defined as the percentage of participants with measurable disease achieving a best overall response of either complete response (CR) or partial response (PR) based on RECIST. CR: disappearance of all target lesions and non-target lesions. PR: at least a 30 percent (%) decrease in the sum of longest diameter (LD) of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits.|Approximately 2 years|ITT analysis set with measurable disease at baseline.|||Percentage of participants|||Number
2682720|NCT01381874|Primary|Overall Survival (OS)|OS was calculated as the time from randomization to death from any cause.|Approximately 3 years|ITT analysis set included all participants randomized into the study.|||Months||95% Confidence Interval|Median
2682721|NCT01381874|Primary|Progression-Free Survival (PFS)|Progression-free survival was defined as the time from randomization to first occurrence of disease progression (either radiographic or clinical), or death from any cause. PFS was determined using radiographic progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) on measurable lesions captured by computed tomography (CT) or magnetic resonance imaging (MRI). Clinical disease progression was considered only when disease progression could not be confirmed by CT or MRI, such as when the disease site is skin, bone marrow, or central nervous system.|Approximately 2 years|Intent-to-Treat (ITT) analysis set included all participants randomized into the study.|||Months||95% Confidence Interval|Median
2682722|NCT01381861|Secondary|Overall Survival|Median overall survival|2 years|Data not collected||||||
2682723|NCT01381861|Secondary|Severity of Adverse Events|Severity of adverse events by NCI CTCAE|28 days post last dose of TRC105|All patients who received at least a portion of a dose of TRC105.|||participants|||Number
2682724|NCT01381861|Secondary|TRC105 Immunogenicity|TRC105 Anti-Drug Antibody (ADA) Immunogenicity by ELISA|1 year|All patients that received at least a portion of TRC105|||Participants|||Count of Participants
2682725|NCT01381861|Secondary|Serum Concentrations of TRC105|Median peak and trough concentration of TRC105 by ELISA in ug/mL|Cycle 1 Day 15|All patients who received at least a portion of a TRC105 dose|||ug/mL||Full Range|Median
2682726|NCT01381861|Secondary|CA-125 Response Rate|CA-125 response rate by GCIG criteria|Every 2 cycles|All patients who received at least a portion of a dose of TRC105|||participants|||Number
2682727|NCT01381861|Primary|Adverse Events|Frequency of adverse events as assessed by NCI CTCAE (Version 4.0)|28 days|All patients who received at least a portion of a dose of TRC105.|||Participants|||Count of Participants
2682728|NCT01381861|Primary|Proportion of Patients Who Have Objective Tumor Response|Proportion of patients who have objective tumor response (complete or partial) by RECIST 1.1|Every 2 cycles|This population will include all patients enrolled in the study who receive at least 1 dose of TRC105 study medication and who undergo at least one on study efficacy assessment or expire due to progressive disease prior to the first efficacy assessment.|||participants|||Number
2682729|NCT01381861|Primary|Progression-free Survival Rate After 6 Months of Treatment on Study|Number of patients ongoing within the study who have not progressed after 6 months of treatment|6 months|This population will include all patients enrolled in the study who receive at least 1 dose of TRC105 study medication and who undergo at least one on study efficacy assessment or expire due to progressive disease prior to the first efficacy assessment.|||participants|||Number
2682738|NCT01381679|Primary|Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level|Individual LDL-C target values were set according to the Austrian Cholesterol Consensus (ACC) 2007 for patients for patients suffering from coronary heart disease (CHD) or CHD equivalent in an office-based, routine medical care setting. Participants were categorized as either high-risk or very high-risk based on ACC criteria. The LDL-C target levels for each category were 100 mg/dL and 70 mg/dL, respectively|Up to 12 months||||Participants|||Number
2682739|NCT01381575|Secondary|Number of Subjects Completing the Vaccination Course|The number of subjects completing the vaccination course was assessed as the number of subjects with at least one dose received during the study.|From Day 0 up to Month 13|The analysis was based on the TVC, which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available.|||Participants|||Count of Participants
2682740|NCT01381575|Secondary|Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies|Outcomes of reported pregnancies were: Ectopic pregnancy, Elective termination NO apparent congenital anomaly (ACA), Live Infant NO ACA, Stillbirth NO ACA.|From Day 0 up to Month 36 (throughout the study period)|The analysis was based on the TVC, which included all subjects with the study vaccine administered and who reported any pregnancies and outcomes of reported pregnancies.|||Participants|||Count of Participants
2682741|NCT01381575|Secondary|Number of Subjects With Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.|From Day 0 up to Month 36 (throughout the study period)|The analysis was based on the TVC, which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available.|||Participants|||Count of Participants
2682742|NCT01381575|Secondary|Number of Subjects With Medically Significant Conditions (MSCs)|MSC include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.|From Day 0 up to Month 36 (throughout the study period)|The analysis was based on the TVC, which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available.|||Participants|||Count of Participants
2682743|NCT01381575|Secondary|Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)|pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.|From Day 0 up to Month 13 (for Cervarix 1 Group and Cervarix 2 Group) and from Day 0 up to Month 18 (for Cervarix 3 Group)|The analysis was based on the TVC, which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available. The data for Cervarix 1 and 2 Groups are only presented up to Month 13, as the data were only collected up to Month 13 for those 2 groups.|||Participants|||Count of Participants
2682744|NCT01381575|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = unsolicited AE preventing normal activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.|During the 30 day (Days 0-29) post-vaccination period|The analysis was based on the TVC, which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available.|||Participants|||Count of Participants
2682745|NCT01381575|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, fever and urticaria. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any fever = axillary temperature ≥ 37.5 degrees Celsius (°C). Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever greater than (>) 39.0 °C. Related = general symptom assessed by the investigator as causally related to the vaccination.|During the 7-day period (Days 0-6) after each vaccine dose and across doses|The analysis was based on the TVC, which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available and symptom sheet completed. Subjects from Cervarix 1 and Cervarix 3 Groups received only 2 doses of vaccine, therefore data are presented up to Dose 2.|||Participants|||Count of Participants
2682746|NCT01381575|Secondary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = redness/swelling above 50 millimeters (mm).|During the 7-day period (Days 0-6) after each vaccine dose and across doses|The analysis was based on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available and symptom sheet completed. Subjects from Cervarix 1 and Cervarix 3 Groups received only 2 doses of vaccine, therefore data are presented up to Dose 2.|||Participants|||Count of Participants
2682747|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects|The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 7 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 7 EL.U/mL) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.|At Day 0 and at Months 13, 18 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity which included a sub-cohort of 100 subjects from Cervarix 3 Group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.|||cells/million B-cells||Inter-Quartile Range|Median
2682748|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects|The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 8 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 8 EL.U/mL) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.|At Day 0 and at Months 13, 18 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity which included a sub-cohort of 100 subjects from Cervarix 3 Group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.|||cells/million B-cells||Inter-Quartile Range|Median
2682749|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects|The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 7 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 7 EL.U/mL) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.|At Day 0 and at Months 7, 12, 24 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity which included a sub-cohort of 100 subjects per study group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.|||cells/million B-cells||Inter-Quartile Range|Median
2682750|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects|The CMI response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration < 8 EL.U/mL) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ 8 EL.U/mL) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.|At Day 0 and Months 7, 12, 24 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity which included a sub-cohort of 100 subjects per study group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.|||cells/million B-cells||Inter-Quartile Range|Median
2682751|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects|The CMI response represents the measure of the cytokines production (i.e. IL-2, IFN-γ, TNF-α, and CD40L) by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-18. The frequency was presented as a number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration < 7 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ 7 EL.U/mL) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.|At Months 0, 13, 18 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity which included a sub-cohort of 100 subjects per study group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.|||cells/million T-cells||Inter-Quartile Range|Median
2682752|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects|The CMI response represents the measure of the cytokines production (IL-2, IFN-γ, TNF-α, and CD40L) by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-16 The frequency was presented as a number of of cytokine-positive cluster of differentiation (CD)4 i.e.CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration < 8 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ 8 El.U/mL) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.|At Day 0 and at Months 13, 18 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity which included a sub-cohort of 100 subjects per study group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.|||cells/million T cells||Inter-Quartile Range|Median
2682753|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects|The CMI response represents the measure of the cytokines production [IL-2, IFN-γ, TNF-α, and CD40L] by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-18. The frequency was presented as a number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration < the cut-off value of 7 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ 7 EL.U/mL) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.|At Day 0 and at Months 7, 12, 24 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity which included a sub-cohort of 100 subjects per study group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.|||cells/million T cells||Inter-Quartile Range|Median
2682783|NCT01381562|Primary|Number of Participants With Normal and Abnormal ECG Findings|12-lead ECGs was obtained during the study using an ECG machine and performed with the participant in a semi-supine position rested in this position for at least 10 minutes beforehand. Measurements deviated substantially from previous readings were repeated immediately. Number of participants with normal and abnormal ECG findings were reported.|Up to Day 42|Safety population.|||Participants|||Count of Participants
2689003|NCT01329978|Secondary|Change in HCV RNA at Week 12||Baseline (Day 1) to Week 12|Participants in the Safety Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2682754|NCT01381575|Secondary|Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects|The CMI response represents the measure of the cytokines production [i.e. interleukin-2 (IL-2), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α) and the cluster of differentiation 40 Ligand (CD40L)] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-16. The frequency was presented as number of cytokine-positive cluster of differentiation (CD)4 i.e. CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration < cut-off value of 8 EL.U/mL) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ 8 El.U/mL) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.|At Day 0 and at Months 7, 12, 24 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity which included a sub-cohort of 100 subjects per study group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.|||cells/million T cells||Inter-Quartile Range|Median
2682755|NCT01381575|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group|Antibody titers were expressed as GMTs. The cut-off of the assay was ≥ 40 ED50 for both anti-HPV-16 and anti-HPV-18. The assay was performed on a subset of 100 subjects per study group.|At Day 0 and at Months 7, 12, 18, 24 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity which included a subset of 100 subjects per study group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.|||Titer||95% Confidence Interval|Geometric Mean
2682756|NCT01381575|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group|Antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was ≥ 40 ED50 for both anti-HPV-16 and anti-HPV-18. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.|At Months 0, 13, 18, 24 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity which included a subset of 100 subjects from Cervarix 3 Group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.|||Titers||95% Confidence Interval|Geometric Mean
2682757|NCT01381575|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group|Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.|At Day 0 and at Months 13, 18, 24 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity which included all subjects seronegative before vaccination, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2682758|NCT01381575|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group|Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations ≥ 8 EL.U/mL and anti-HPV-18 concentrations ≥ 7 EL.U/mL, respectively) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration < 8/7 EL.U/mL. A seropositive subject was a subject with anti-HPV-16/18 antibody concentration ≥ 8/7 EL.U/mL.|At Day 0 and at Months 13, 18, 24 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity which included all subjects seronegative before vaccination, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.|||Participants|||Count of Participants
2682759|NCT01381575|Secondary|Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36|Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.|At Day 0 and at Months 7, 12, 18, 24 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity which included all subjects seronegative before vaccination, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2682760|NCT01381575|Secondary|Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36|Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations ≥ 8 EL.U/mL and anti-HPV-18 concentrations ≥ 7 EL.U/mL, respectively) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration < 8/7 EL.U/mL. A seropositive subject was a subject with anti-HPV-16/18 antibody concentration ≥ 8/7 EL.U/mL.|At Day 0 and at Months 7, 12, 18, 24 and 36|The analysis was based on the Month 36 ATP cohort for immunogenicity which included all subjects seronegative before vaccination, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.|||Participants|||Count of Participants
2682761|NCT01381575|Primary|Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Month 7|Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.|At Month 7 (i.e. one month after the last dose of study vaccine)|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component at Month 7.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2682784|NCT01381562|Primary|Number of Participants With Clinically Significant Trends in Vital Signs Over the Period of Study Duration|Vital parameters including systolic and diastolic blood pressure, heart rate, respiration rate, and temperature were recorded. The number of participants with potentially clinically concern value of any vital parameter at any visit were reported.|Up to Day 42|Safety Population.|||Participants|||Count of Participants
2689004|NCT01329978|Secondary|Change in HCV RNA at Week 8||Baseline (Day 1) to Week 8|Participants in the Safety Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2682762|NCT01381575|Primary|Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervarix 1 Group and Cervarix 2 Group at Month 7|Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 concentrations ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration lower than (<) 8/7 EL.U/mL, respectively. A seropositive subject was a subject with anti-HPV-16/18 antibody concentration ≥ 8/7 EL.U/mL, respectively.|At Month 7 (i.e. one month after the last dose of study vaccine)|The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component at Month 7.|||Participants|||Count of Participants
2682763|NCT01381562|Secondary|Tmax of GSK2251052 Using Intensive PK Sampling|Tmax was planned to be determined. A nonlinear mixed effects model as implemented in the program NONMEM was planned to be used to analyze plasma concentration data. However, data for PK analysis was not collected.|Day 5: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose|PK population. Data for PK analysis was not collected.||||||
2682764|NCT01381562|Secondary|AUC of GSK2251052 Using Intensive PK Sampling|AUC was planned to be determined. A nonlinear mixed effects model as implemented in the program NONMEM was planned to be used to analyze plasma concentration data. However, data for PK analysis was not collected.|Day 5: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose|PK population. Data for PK analysis was not collected.||||||
2682765|NCT01381562|Secondary|Cmax of GSK2251052 Using Intensive PK Sampling|Cmax was planned to be determined. A nonlinear mixed effects model as implemented in the program NONMEM was planned to be used to analyze plasma concentration data. However, data for PK analysis was not collected.|Day 5: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose|PK population. Data for PK analysis was not collected.||||||
2682766|NCT01381562|Secondary|Tmax of GSK2251052 Using Non-intensive PK Sampling|Tmax was planned to be determined. A nonlinear mixed effects model as implemented in the program NONMEM was planned to be used to analyze plasma concentration data. However, data for PK analysis was not collected.|Day 5: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|PK population. Data for PK analysis was not collected.||||||
2682767|NCT01381562|Secondary|AUC of GSK2251052 Using Non-intensive PK Sampling|AUC was planned to be determined. A nonlinear mixed effects model as implemented in the program NONMEM was planned to be used to analyze plasma concentration data. However, data for PK analysis was not collected.|Day 5: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|PK population. Data for PK analysis was not collected.||||||
2682768|NCT01381562|Secondary|Cmax of GSK2251052 Using Non-intensive PK Sampling|Cmax was planned to be determined. A nonlinear mixed effects model as implemented in the program NONMEM was planned to be used to analyze plasma concentration data. However, data for PK analysis was not collected.|Day 5: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|PK population. Data for PK analysis was not collected.||||||
2682769|NCT01381562|Secondary|Time to Cmax (Tmax) of GSK2251052|Tmax was planned to be determined. A nonlinear mixed effects model as implemented in the program NONMEM was planned to be used to analyze plasma concentration data. However, data for PK analysis was not collected.|Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|PK population. Data for PK analysis was not collected.||||||
2682770|NCT01381562|Secondary|Area Under the Concentration Time Curve (AUC) of GSK2251052|AUC was planned to be determined. A nonlinear mixed effects model as implemented in the program NONMEM was planned to be used to analyze plasma concentration data. However, data for PK analysis was not collected.|Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|PK population. Data for PK analysis was not collected.||||||
2682771|NCT01381562|Secondary|Maximum Plasma Concentration (Cmax) of GSK2251052|Cmax was planned to be determined. A nonlinear mixed effects model as implemented in the program NONMEM was planned to be used to analyze plasma concentration data. However, data for pharmacokinetics (PK) analysis was not collected.|Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|PK population consisted of participants for whom PK samples were collected. Data for PK analysis was not collected.||||||
2682772|NCT01381562|Secondary|Number of Participants With Therapeutic Response in MITT Population|Therapeutic response was a measure of the overall efficacy response, and a therapeutic success referred to participants who had been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic response. Therapeutic response was determined programmatically.|End of IV therapy (0-24 hours post-therapy); Test of cure (5-9 days post-therapy); Late Follow-up (21-28 days post-therapy)|MITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2682773|NCT01381562|Secondary|Number of Participants With Therapeutic Response in Microbiological Evaluable Population|Therapeutic response was a measure of the overall efficacy response, and a therapeutic success referred to participants who had been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic response. Therapeutic response was determined programmatically.|End of IV therapy (0-24 hours post-therapy); Test of cure (5-9 days post-therapy); Late Follow-up (21-28 days post-therapy)|Microbiological evaluable population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2695810|NCT01275339|Secondary|Change in Circulating Neurohormonal Markers|BNP and systemic markers of collagen turnover and oxidative stress|6 and 12 weeks and 6 months|||||||
2682774|NCT01381562|Secondary|Number of Participants With Clinical Response in MITT Population|Clinical success was defined as resolution or improvement of Baseline signs and symptoms of cIAI, including white blood cell count within normal limits, participant was afebrile and peritoneal findings consistent with cIAI were no longer present with no new symptoms present that were not present at Baseline and no use of additional or alternate antibiotic therapy. Clinical failure was defined as (1) Lack of improvement or worsening in one or more signs and symptoms of cIAI recorded at Baseline, or reappearance of signs and symptoms that had previously resolved, or (2) signs and symptoms recorded that were not present at Baseline, or (3) receipt of additional or alternate antibiotic therapy for cIAI or (4) participant had died, or (5) participant had an adverse event leading to study drug discontinuation and the participant required additional or alternative antibacterial therapy for the current cIAI.|End of IV therapy (0-24 hours post-therapy) and Late Follow-up (21-28 days post-therapy)|MITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2682775|NCT01381562|Secondary|Number of Participants With Clinical Response in Microbiological Evaluable Population|Clinical success was defined as resolution or improvement of Baseline signs and symptoms of cIAI, including white blood cell count within normal limits, participant was afebrile and peritoneal findings consistent with cIAI were no longer present with no new symptoms present that were not present at Baseline and no use of additional or alternate antibiotic therapy. Clinical failure was defined as (1) Lack of improvement or worsening in one or more signs and symptoms of cIAI recorded at Baseline, or reappearance of signs and symptoms that had previously resolved, or (2) signs and symptoms recorded that were not present at Baseline, or (3) receipt of additional or alternate antibiotic therapy for cIAI or (4) participant had died, or (5) participant had an adverse event leading to study drug discontinuation and the participant required additional or alternative antibacterial therapy for the current cIAI.|End of IV therapy (0-24 hours post-therapy); Test of cure (5-9 days post-therapy); Late Follow-up (21-28 days post-therapy)|Microbiological evaluable population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2682776|NCT01381562|Secondary|Number of Participants With Microbiological Response in Microbiological Evaluable Population|Microbiological Response at End of IV Therapy was assessed as MS or MF. MS was categorized as ME and PME. MF was categorized as MP and PMP, unable to determine, new infection and colonization. Number of participants with microbiological response in microbiological evaluable population were reported.|End of IV therapy (0-24 hours post-therapy); Test of cure (5-9 days post-therapy); Late Follow-up (21-28 days post-therapy)|Microbiological evaluable population. Only those participants available at the specified time points were analyzed|||Participants|||Count of Participants
2682777|NCT01381562|Secondary|Number of Participants With Microbiological Response in MITT Population|Microbiological Response at End of IV Therapy was assessed as Microbiological Success (MS) or Microbiological Failure (MF). MS was categorized as microbiological eradication (ME) and presumed microbiological eradication (PME). MF was categorized as microbiological persistence (MP), presumed microbiological persistence (PMP), unable to determine, new infection and colonization. Number of participants with microbiological response in MITT population were reported.|End of IV therapy (0-24 hours post-therapy); Test of cure (5-9 days post-therapy); Late Follow-up (21-28 days post-therapy)|MITT Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2682778|NCT01381562|Secondary|Number of Participants With Clinical Response at Test of Cure Visit (5-9 Days Post-therapy) in Microbiological Evaluable Population.|Test of cure-clinical success was resolution of signs and symptoms of complicated intra-abdominal infection (cIAI) for participants who were clinical successes at the end of IV therapy visit with no new symptoms recorded that were not present at Baseline and no use of additional antibiotic therapy for cIAI. Test of cure-clinical failure was persistence of signs and symptoms of cIAI recorded at Baseline, or reappearance of signs and symptoms that had previously resolved, or new signs and symptoms recorded that were not present at a previous visit, or receipt of additional or alternate antibiotic therapy for cIAI or participant had died. Test of cure- unable to determine was refusal to consent to a clinical examination, lost to follow-up. Participants who were 'unable to determine' at End of IV therapy were considered 'unable to determine' Test of cure Visit as well. Due to early termination of the study, a Bayesian approach for informal hypothesis testing was not performed.|Day 5 to 9 post IV therapy|Microbial evaluation population comprised of participants from the MITT population who adhered to the protocol (do not violate the protocol) and received at least 5 days of IV therapy.|||Participants|||Count of Participants
2682779|NCT01381562|Primary|Number of Participants With Clinical Response at Test of Cure Visit (5-9 Days Post-therapy) in Microbiological Intent to Treat (MITT) Population|Test of cure-clinical success was resolution of signs and symptoms of complicated intra-abdominal infection (cIAI) for participants who were clinical successes at the end of IV therapy visit with no new symptoms recorded that were not present at Baseline and no use of additional antibiotic therapy for cIAI. Test of cure-clinical failure was persistence of signs and symptoms of cIAI recorded at Baseline, or reappearance of signs and symptoms that had previously resolved, or new signs and symptoms recorded that were not present at a previous visit, or receipt of additional or alternate antibiotic therapy for cIAI or participant had died. Test of cure- unable to determine was refusal to consent to a clinical examination, lost to follow-up. Participants who were 'unable to determine' at End of IV therapy were considered 'unable to determine' Test of cure Visit as well. Due to early termination of the study, a Bayesian approach for informal hypothesis testing was not performed.|Day 5 to 9 post IV therapy|MITT Population comprised of all randomized participants who received at least one dose of study medication and had at least one Gram-negative pathogen identified at Baseline. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2682780|NCT01381562|Primary|Mean Change From Baseline in Hemoglobin for Partcipants With Significant Hemoglobin Drop|Participants in whom the hemoglobin level dropped by more than 30% from Baseline that was not attributable to acute blood loss were recorded and immediately withdrawn from study treatment. Baseline assessments were recorded on Visit 1 (Day 1) and used as Baseline values. The change from Baseline was calculated by subtracting the Baseline values from Day 42 values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing. The mean change from Baseline in hemoglobin for participants with significant hemoglobin drop were reported.|Baseline (Day 1) and up to Day 42|Safety Population. Only those participants available at the specified time points were analyzed.|||grams/L||Standard Deviation|Mean
2682785|NCT01381562|Primary|Number of Participants With Any Adverse Event|AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE included AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition|Up to Day 42|Safety Population comprised of all participants who received at least one dose of study medication.|||Participants|||Count of Participants
2682786|NCT01381549|Secondary|Tmax of GSK2251052 Using Intensive PK Sampling|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 4: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose|||||||
2682787|NCT01381549|Secondary|AUC of GSK2251052 Using Intensive PK Sampling|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 4: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose|||||||
2682788|NCT01381549|Secondary|Cmax of GSK2251052 Using Intensive PK Sampling|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 4: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose|||||||
2682789|NCT01381549|Secondary|Tmax of GSK2251052 Using Non-intensive PK Sampling|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 4: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|||||||
2682790|NCT01381549|Secondary|AUC of GSK2251052 Using Non-intensive PK Sampling|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 4: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|||||||
2682791|NCT01381549|Secondary|Cmax of GSK2251052 Using Non-intensive PK Sampling|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 4: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|||||||
2682792|NCT01381549|Secondary|Time to Cmax (Tmax) of GSK2251052|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|||||||
2682793|NCT01381549|Secondary|Area Under the Concentration Time Curve (AUC) of GSK2251052|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|||||||
2682794|NCT01381549|Secondary|Maximum Plasma Concentration (Cmax) of GSK2251052|The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.|Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose|||||||
2682795|NCT01381549|Secondary|Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit|The therapeutic response was the combination of a participant's clinical and microbiological response. It was assessed at the Test of Cure visit in participants who have a qualifying Gram-negative uropathogen at Baseline and have had a minimum of 5 days of IV therapy. Therapeutic response was a measure of the overall efficacy response, and a therapeutic success referred to participants who have been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic response.|End of IV therapy (0-24 hours post-therapy) and Late Follow-up (21-28 days post-therapy)|MITT Population.|||Participants|||Count of Participants
2682796|NCT01381549|Secondary|Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit|Clinical response was a combination of clinical success and clinical failure. In clinical success, participants showed no signs and symptoms of pyelonephritis and lower complicated urinary tract infection and antibiotics are not used for the same. In clinical failure, there is reappearance of signs and symptoms of and lower complicated urinary tract infection and participant required antibiotics for the same.|End of IV therapy (0-24 hours post-therapy), Test of Cure Visit (5 to 9 days post-IV therapy) and Late Follow-up (21-28 days post-therapy)|MITT Population.|||Participants|||Count of Participants
2682797|NCT01381549|Secondary|Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit|Microbiological response involved both microbiological success and microbiological failure. A reduction in the uropathogens in the urine culture and no growth on blood culture was termed as microbiological success. Increase in the uropathogens in the urine culture and pathogens identified in the blood culture or use of antibacterials other than study treatments were classified as microbiological failures.|End of IV therapy (0-24 hours post-therapy), Test of Cure Visit (5 to 9 days post-IV therapy) and Late Follow-up (21-28 days post-therapy)|MITT Population.|||Participants|||Count of Participants
2682798|NCT01381549|Primary|Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC)|Hematology parameters included basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils and WBC. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils and WBC are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Gigacells per Liter||Standard Deviation|Mean
2682799|NCT01381549|Primary|Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)|Hematology parameters included hemoglobin and MCHC. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in hemoglobin and MCHC are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Gram per Liter||Standard Deviation|Mean
2682800|NCT01381549|Primary|Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes|Hematology parameters included RBC count and reticulocytes. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in RBC count and reticulocytes are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Trillion cells per liter||Standard Deviation|Mean
2682801|NCT01381549|Primary|Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV)|Hematology parameters included MCV. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in MCV are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Femtoliters||Standard Deviation|Mean
2682802|NCT01381549|Primary|Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH)|Hematology parameters included MCH. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in MCH are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Picograms||Standard Deviation|Mean
2682803|NCT01381549|Primary|Change From Baseline in Hematology Parameters- Hematocrit|Hematology parameters included hematocrit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in hematocrit are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Fraction||Standard Deviation|Mean
2682804|NCT01381549|Primary|Therapeutic Response at the Test of Cure Visit|The therapeutic response was the combination of a participant's clinical and microbiological response. It was assessed at the Test of Cure visit in participants who have a qualifying Gram-negative uropathogen at Baseline and have had a minimum of 5 days of IV therapy. Therapeutic response was a measure of the overall efficacy response, and a therapeutic success referred to participants who have been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic response.|Test of Cure Visit (5 to 9 days post-IV therapy)|Microbiological Intent to Treat (MITT) comprised of all randomized participants who received at least one dose of study medication and had at least one gram-negative uropathogen and no more than two gram-negative uropathogens (≥10^5 Colony forming units [CFU]/mL for each pathogen) identified from Baseline urine culture.|||Participants|||Count of Participants
2682805|NCT01381549|Primary|Summary of Vital Signs- Mean Temperature|Vital sign measurements included temperature (oral, tympanic or rectal). Measurements that deviated substantially from previous readings were repeated immediately. Temperature was assessed as normal hospital practice dictated and the maximum daily temperature was recorded in the electronic case report form (eCRF).|Up to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Celsius||Standard Deviation|Mean
2682806|NCT01381549|Primary|Summary of Vital Signs- Mean Respiration Rate|Vital sign measurements included respiratory rate. Measurements that deviated substantially from previous readings were repeated immediately. Mean respiration rate are presented.|Up to Late Follow-up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Breaths/minute||Standard Deviation|Mean
2682807|NCT01381549|Primary|Summary of Vital Signs- Mean Heart Rate|Vital sign measurements included heart rate. Measurements that deviated substantially from previous readings were repeated immediately. Mean heart rate is presented.|Up to Late Follow-up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2682808|NCT01381549|Primary|Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital sign measurements included SBP and DBP (supine or semi-supine). Measurements that deviated substantially from previous readings were repeated immediately. Mean SBP and DBP are presented.|Up to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2682809|NCT01381549|Primary|Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Twelve lead ECGs were obtained during the study using an ECG machine that automatically measured PR, QRS, QT, and QT corrected by Bazett's formula (QTcB), QT corrected by Fridericia's formula (QTcF) intervals. Twelve lead ECGs were performed with the participant in a semi-supine position having rested in this position for at least 10 minutes beforehand. Measurements that deviated substantially from previous readings were repeated immediately. Three measurements were taken at pre-dose on Day 1 at least 5 min apart. One additional ECG measurement was taken after completion of the first infusion of study medication. Two ECG measurements (pre and post-1st infusion of the day) were taken on Day 4 while the participant was on IV therapy. When there was an abnormal finding, two more were taken and the mean PR interval, QRS duration, QT interval and QTcB were calculated from automated ECG readings. One ECG measurement was taken at the early safety follow-up visit.|Up to Late Follow-up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2682835|NCT01380782|Other Pre-specified|Exploratory Objective #4: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Perfusion MRI, Diffusion MRI|To explore the correlation between perfusion MRI, diffusion MRI and response to therapy.|2 years|||||||
2695811|NCT01275339|Secondary|Change in 6 Minute Walk Distance||6 and 12 weeks and 6 months|||||||
2682810|NCT01381549|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.|Up to 28 days post-therapy|Safety Population.|||Participants|||Count of Participants
2682811|NCT01381549|Primary|Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT)|Clinical laboratory parameters included ALT, ALP, AST, Creatine kinase and GGT. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in ALT, ALP, AST, Creatine kinase and GGT are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||International units per Liter||Standard Deviation|Mean
2682812|NCT01381549|Primary|Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)|Clinical laboratory parameters included C02 content/bicarbonate, chloride, glucose, potassium, sodium and urea/BUN. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in C02 content/bicarbonate, chloride, glucose, potassium, sodium and urea/BUN are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Millimole per Liter||Standard Deviation|Mean
2682813|NCT01381549|Primary|Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin|Clinical laboratory parameters included creatinine, direct bilirubin and total bilirubin. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in creatinine, direct bilirubin and total bilirubin are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Micromole per liter||Standard Deviation|Mean
2682814|NCT01381549|Primary|Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE)|Clinical laboratory parameters included CCE. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in CCE are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population. Only those participants available at the specified time points were analyzed.|||Milliliter per minute||Standard Deviation|Mean
2682815|NCT01381549|Primary|Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein|Clinical laboratory parameters included albumin and total protein. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in albumin and total protein are presented.|Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)|Safety Population which comprised of all participants who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.|||Gram per Liter||Standard Deviation|Mean
2682816|NCT01381471|Primary|Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period|The mean number of outpatient office visits, inpatient visits, and emergency department visits incurred by participants during the one-year post-index period was measured.|One Year|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of COPD (ICD-9 codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)|||healthcare encounters||Standard Deviation|Mean
2682817|NCT01381471|Primary|Mean Number of Pharmacy Claims by Participants During the Post-Index Period|The mean number of pharmacy claims incurred by participants during the one-year post-index period was measured.|One Year|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of COPD (ICD-9 codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)|||pharmacy claims||Standard Deviation|Mean
2682818|NCT01381406|Secondary|Incidence Rate of Hospitalizations and Emergency Room Visits Per 100 Person Years|Unadjusted incidence rates per 100 person years of chronic obstructive pulmonary disease (COPD)-related hospitalizations and emergency department visits by treatment group are presented. Incidence rate is calculated by dividing the number of healthcare service encounters by the number of person years of follow up. Person years adjust for different lengths of follow up for individual participants|Data were collected over a maximum period of 4 years|Managed care enrollees (aged >40 years) with at least one COPD-related exacerbation at baseline and newly initiating therapy with TIO with or without the addition of FSC during the study enrollment period was the target population. The date of TIO-alone therapy or TIO+FSC add-on date was the index date.|||visits per 100 person years|||Number
2682836|NCT01380782|Other Pre-specified|Exploratory Objective #3: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Serum Angiogenic Peptides, Circulating Endothelial Cells, and/or Circulating Progenitor Cells|To explore the correlation between serum angiogenic peptides, circulating endothelial cells, and circulating progenitor cells with response to therapy.|2 years|||||||
2682837|NCT01380782|Other Pre-specified|Exploratory Objective #2: Determination if Any Correlation Exists Between Patient Outcomes (Survival, PFS3, PFS6) and Tumor Genotype and/or Expression Profile|To explore the extent to which the tumor's genotype and expression profile correlate with outcome.|2 years|||||||
2689005|NCT01329978|Secondary|Change in HCV RNA at Week 4||Baseline (Day 1) to Week 4|Participants in the Safety Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2682819|NCT01381406|Secondary|Adjusted Mean Monthly Costs Per COPD Patient by Treatment Group|The mean costs of health care encounters adjusted to control for baseline differences between treatment groups and reported in 2008 United States dollars as calculated with the consumer price index (CPI) are presented. CPI is standard multiplier for adjusting the cost of goods and services to a single year. Total costs include pharmacy and medical costs. Medical costs were computed from the paid amounts of medical claims with a primary diagnosis code for COPD. COPD-related pharmacy costs were computed from paid amounts of COPD-related prescription medications.|Data were collected over a maximum period of 4 years|Managed care enrollees (aged >40 years) with at least one COPD-related exacerbation at baseline and newly initiating therapy with TIO with or without the addition of FSC during the study enrollment period was the target population. The date of TIO-alone therapy or TIO+FSC add-on date was the index date.|||United States dollars||95% Confidence Interval|Mean
2682820|NCT01381406|Primary|Incidence Rate Per 100 Person Years of Hospitalization or Emergency Department (ED) Visit Related to Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)|A severe exacerbation is defined as one with a primary diagnosis of COPD. A moderate exacerbation is an ED visit with a primary diagnosis of COPD, a physician visit with a diagnosis of COPD and a prescription for an oral corticosteroid, a physician visit with a diagnosis code for COPD and an antibiotic for respiratory infection, or physician administration of nebulized albuterol within 3 days of an office visit. Incidence rate is calculated by dividing the number of exacerbations by the number of person years. Person years adjust for different lengths of follow up for participants.|Data were collected over a maximum period of 4 years|Managed care enrollees (aged >40 years) with at least one COPD-related exacerbation at baseline and newly initiating therapy with TIO with or without the addition of FSC during the study enrollment period was the target population. The date of TIO-alone therapy or TIO+FSC add-on date was the index date.|||exacerbations per 100 person years|||Number
2682821|NCT01381120|Secondary|Change in Post-ureteroscopy Stent-induced Lower Urinary Tract Symptoms.|Measured through the use of the ureteral stent symptom questionnaire. Patients reported symptoms on a scale of 1 to 5 (1 being the absence of symptoms and 5 being very debilitating symptoms). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure.|Baseline and three months.||||units on a scale||95% Confidence Interval|Mean
2682822|NCT01381120|Primary|Change in Post-ureteroscopy Stent-induced Pain|Measured through the use of the ureteral stent symptom questionnaire. Patients reported pain on a scale of 0 to 10 (0 being the absence of pain and 10 being the most excruciating pain of their life). The questionnaire was administered a couple days post-op and once again several weeks later. The mean difference (baseline minus 3 months) on this continuous scale was used for this outcome measure.|Baseline and 3 months.||||units on a scale||95% Confidence Interval|Mean
2682823|NCT01381068|Secondary|Systemic Blood Flow - as Measured by Supervior Vena Cava (SVC) Flow|An echocardiogram performed within the first 12 hours of life will measure supervior vena cava (SVC) flow.|Within 12 hours of life|The echocardiograms were not performed on all patients because of lack of available staff|||ml/kg/min||Standard Deviation|Mean
2682824|NCT01381068|Secondary|Number of Patients Ventilated on NICU Admission|At the time of NICU admission directly after the DR resuscitation the number of patients ventilated will be reported per group|On NICU admission, approximately 15 minutes of life|Only 7 patients were ventilated on admission to the NICU- data not presented|||Participants|||Count of Participants
2682825|NCT01381068|Secondary|Incidence of Pneumothorax/Airleak|This outcome will be counted as yes if any pneumothorax or airleak is noted on any chest xray during the hospitalization.|Hospital course, approximately 2-3 months||||Participants|||Count of Participants
2682826|NCT01381068|Secondary|Oxygen Use at 36 Weeks|This outcome will be counted as yes if the infant is receiving oxygen at 36 weeks adjusted age.|Hospital course, approximately 2-3 months||||Participants|||Count of Participants
2682827|NCT01381068|Secondary|Duration of Ventilation|The number of days on the ventilator during the entire hospital course will be counted for this outcome.|Duration of the hospital course, approximately 2-3 months||||days||Full Range|Mean
2682828|NCT01381068|Secondary|End Tidal CO2 Levels|The EtCO2 levels from the last 5 breaths of the DR resuscitation will be averaged to determine this outcome.|At the conclusion of resuscitation, approximately 15 minutes of life.||||mmHg||Full Range|Mean
2682829|NCT01381068|Primary|PCO2 Level Outside of Desired Range (40-60 mmHg)|This outcome will be obtained from the first available blood gas after admission to the NICU.|Admission to NICU, approximately 1 hour of life||||participants|||Number
2682830|NCT01381016|Primary|Luteinizing Hormone Pulse Amplitude||Post estradiol at one month||||IU/L||Standard Error|Mean
2682831|NCT01381016|Primary|Luteinizing Hormone Pulse Amplitude|The study is powered on luteinizing hormone pulse amplitude because it is the clinical outcome for which the most data is available. The primary comparison is whether there is a significant reduction in the pulse amplitude in the obese between the pre- and post-treatment periods and whether there is no change in the pulse amplitude in the normal weight patients between the pre and post-treatment periods.|Baseline||||IU/L||Standard Error|Mean
2682832|NCT01380834|Secondary|Opioid Consumption|Other secondary end points will total amount of fentanyl (mcg/kg), dilaudid (mcg/kg), oxycodone (mg/kg) and morphine (mg/kg) (after conversion of above opioids to morphine based on opioids potency) used at 24 hours postoperatively (or until the patient is discharged, if sooner).|24 hrs after blocks were done or until the patient is discharged||||mg/kg||Standard Deviation|Mean
2682833|NCT01380834|Secondary|Postoperative Pain Scores Assessed Using Visual Analog Scale (VAS).|"The VAS (Visual Analog Scale, 0 mm no pain, to 100 mm, the worst pain possible ) is used to assess postoperative pain for patients. Postoperative pain scores will be assessed and compared at 4, 8, 12, 18 and 24 hr after paravertebral block."|24 hrs after blocks were done or until the patient is discharged||||units on a scale||Standard Deviation|Mean
2682834|NCT01380834|Primary|Opioids Consumption Via PCA|The primary end-point of this research is the amount of dilaudid (ng/kg/min) administered via Patient Controlled Analgesia (PCA), 12 hours after administration of ropivacaine 0.5% /normal saline in paravertebral space and administration of normal saline/ropivacaine 0.5% at all four laparoscopic ports.|12 hrs after the blocks were done||||ng/kg/min||Standard Deviation|Mean
2689006|NCT01329978|Secondary|Change in HCV RNA at Week 2||Baseline (Day 1) to Week 2|Participants in the Safety Analysis Set with available data were analyzed.|||log10 IU/mL||Standard Deviation|Mean
2682842|NCT01380782|Secondary|Proportion of Participants Experiencing Stable Disease (SD) as Their Best Radiographic Response|Best radiographic response in both populations. There were no participants with partial or complete responses, so the results are being reported in the proportion of participants who experienced stable disease (SD) as their best response (as opposed to progressive disease).|2 years||||% of patients with best response SD|||Number
2682843|NCT01380782|Primary|3-Month Progression Free Survival|To determine the efficacy of BIBF 1120 in bevacizumab-treated participants with recurrent GBM as measured by 3-month progression free survival (PFS3).|3 months||||percentage of participants|||Number
2682844|NCT01380782|Primary|6-Month Progression Free Survival|To determine the efficacy of BIBF 1120 in bevacizumab-naive participants with recurrent glioblastoma (GBM) as measured by 6-month progression-free survival (PFS6).|Six months||||percentage of participants|||Number
2682845|NCT01380769|Secondary|Assess Objective Response Rate (ORR) of CRLX101+ BSC Compared to BSC Only|Comparison of objective response rate in subjects treated with CRLX101+BSC versus subjects treated with BSC alone.|12 months|Intention-To-Treat (ITT)|||Percentage of Participants|||Number
2682846|NCT01380769|Primary|To Compare Overall Survival of Patients Treated With CRLX101 + BSC to Those Patients Treated With BSC Only|Comparison of survival among patients treated with CRLX101 + best supportive care vs patients treated wiht best supportive care only.|Up to 18 months|Intention-to-treat (ITT) and Patient Safety Population (PSP), includes all CRLX101 + BSC subjects who received at least 1 dose of study treatment and all randomized BSC alone subjects who attended at least 1 study visit. (Confidence interval if insufficient data to estimate NE = 99999.99)|||months||95% Confidence Interval|Median
2682847|NCT01380743|Secondary|Duvoglustat Concentration In Skeletal Muscle|"The concentration of duvoglustat in skeletal muscle tissue homogenate was measured after pre-administration of single ascending oral doses of duvoglustat during Treatment Period 2. Participants had skeletal muscle biopsies at either Day 3 or Day 7 during Treatment Period 2.~Three participants were excluded from this analysis due to the following reasons: treatment sequence was inadvertently switched due to study site error, follow-up biopsy sample could not be conclusively identified, or muscle biopsies were mislabeled at the clinical site.~Values presented are arithmetic mean (percent coefficient of variation, [CV%]) because of the prevalence of participants with values below the limit of quantification. Concentrations below the limit of quantification were treated as zero."|Day 3 or Day 7|The Per Protocol population included all participants who successfully completed both periods.|||ng/g||Geometric Coefficient of Variation|Geometric Mean
2682848|NCT01380743|Secondary|Total GAA Activity In Skeletal Muscle|The total GAA activity in skeletal muscle was measured after a single intravenous administration of rhGAA alone and after pre-administration of single ascending oral doses of duvoglustat. Participants were assessed using skeletal muscle biopsies at either Day 3 or Day 7 during Treatment Periods 1 and 2.|Day 3 or Day 7|The Per Protocol population included all participants who successfully completed both periods.|||pmol/mg/h||Geometric Coefficient of Variation|Geometric Mean
2682849|NCT01380743|Primary|PK: AUC From Time 0 Extrapolated To Infinity (AUCinf) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease|"The AUCinf of total GAA and rhGAA protein in plasma was measured after a single rhGAA intravenous infusion and after pre-administration of single ascending oral doses of duvoglustat.~During Treatment Period 1, participants received a single intravenous infusion of rhGAA. During Treatment Period 2, participants received a single oral dose of duvoglustat 1 hour before initiation of a single rhGAA intravenous infusion. PK samples were taken at time points Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2.~The number of participants analyzed for some cohorts are reduced because the terminal phase of the concentration profile for these participants was not estimable."|Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2|The Per Protocol population included all participants who successfully completed both periods.|||h*(nmol/mL/h)||Geometric Coefficient of Variation|Geometric Mean
2682850|NCT01380743|Primary|PK: Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Time Of The Last Measurable Concentration (AUC0-t) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease|"The AUC0-t of total GAA and rhGAA protein in plasma was measured after a single rhGAA intravenous infusion and after pre-administration of single ascending oral doses of duvoglustat.~During Treatment Period 1, participants received a single intravenous infusion of rhGAA. During Treatment Period 2, participants received a single oral dose of duvoglustat 1 hour before initiation of a single rhGAA intravenous infusion. PK samples were taken at time points Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2."|Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2|The Per Protocol population included all participants who successfully completed both periods.|||nmol/mL/h||Geometric Coefficient of Variation|Geometric Mean
2682851|NCT01380743|Primary|PK: Elimination Half-life (T1/2) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease|"The T1/2 of total GAA and rhGAA protein in plasma was measured after a single rhGAA intravenous infusion and after pre-administration of single ascending oral doses of duvoglustat.~During Treatment Period 1, participants received a single intravenous infusion of rhGAA. During Treatment Period 2, participants received a single oral dose of duvoglustat 1 hour before initiation of a single rhGAA intravenous infusion. PK samples were taken at time points Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2.~Values presented are arithmetic mean (percent coefficient of variation, [CV%]). The number of participants analyzed for some cohorts are reduced because the terminal phase of the concentration profile for these participants was not estimable."|Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2|The Per Protocol population included all participants who successfully completed both periods.|||h||Geometric Coefficient of Variation|Geometric Mean
2682890|NCT01380327|Secondary|Change in German Cockroach-Specific Serum IgG Over Time|Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum immunoglobulin G (IgG). This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 3 months of treatment|Intent-to-treat population with complete data.|||Ratio||95% Confidence Interval|Geometric Mean
2682852|NCT01380743|Primary|PK: Time To The Maximum Plasma Concentration (Tmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease|"The Tmax of total GAA and rhGAA protein in plasma was measured after a single rhGAA intravenous infusion and after pre-administration of single ascending oral doses of duvoglustat.~During Treatment Period 1, participants received a single intravenous infusion of rhGAA. During Treatment Period 2, participants received a single oral dose of duvoglustat 1 hour before initiation of a single rhGAA intravenous infusion. PK samples were taken at time points Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2."|Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2|The Per Protocol population included all participants who successfully completed both periods.|||h||Full Range|Median
2682853|NCT01380743|Primary|Pharmacokinetics (PK): Maximum Measured Plasma Concentration (Cmax) Of Total GAA And rhGAA Protein In Plasma In Participants With Pompe Disease|"The Cmax of total GAA and rhGAA protein in plasma was measured after a single rhGAA intravenous infusion and after pre-administration of single ascending oral doses of duvoglustat.~During Treatment Period 1, participants received a single intravenous infusion of rhGAA. During Treatment Period 2, participants received a single oral dose of duvoglustat 1 hour before initiation of a single rhGAA intravenous infusion. PK samples were taken at time points Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2."|Predose, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, and 24 hours, and 3 or 7 days postdose during Periods 1 and 2, and 24 to 30 days postdose during Period 2|The Per Protocol population included all participants who successfully completed both periods.|||nmol/mL/h||Geometric Coefficient of Variation|Geometric Mean
2682854|NCT01380743|Primary|Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs)|"A TEAE was defined as an adverse event (AE) with an onset date on or after the first dose of investigational medicinal product (IMP), or an AE with an onset date before the first dose date that worsened in severity after the first dose date. A severe AE was defined as an AE that was incapacitating and required medical intervention. The number of participants who experienced 1 or more severe TEAEs after dosing on Day 1 up to Day 60 (includes end of study follow-up period) is reported.~A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module."|Day 1 after dosing up to Day 60|The Safety Population included all participants who were enrolled and received at least 1 dose of rhGAA or duvoglustat.|||Participants|||Count of Participants
2682855|NCT01380730|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2682856|NCT01380730|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2682857|NCT01380730|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2682858|NCT01380730|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2682859|NCT01380730|Secondary|Change From Baseline in LDL-C at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||mg/dL||Standard Error|Least Squares Mean
2682860|NCT01380730|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing ultracentrifugation LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.|||percent change||Standard Error|Least Squares Mean
2682861|NCT01380691|Secondary|Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Self-Ratings of Calmness and Contentment|Assessed via the Bond and Lader Visual Analogue Scale (VAS), which utilizes a 16-point scale of 0 to 100 with 0 representing the worst rating and 100 representing the best rating. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect.|Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours|Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable calmness and contentment self-ratings.|||units on a scale||95% Confidence Interval|Least Squares Mean
2682862|NCT01380691|Secondary|Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Speed of Retrieval of Information From Memory|"Speed of retrieval is a measure of complex information processing speed, summing reaction times from the two working memory (numeric and spatial) tasks and the two episodic recognition (word recognition and picture recognition) tasks. This composite score reflects the time it takes to decide correctly whether an item is held in working memory or episodic secondary memory.Scores are measured by response latencies, and smaller scores indicate better function. A negative change from baseline reflects impairment compared to baseline.~LS means calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect."|Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours|Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable speed of retrieval of information from memory data.|||millisecond (msec)||95% Confidence Interval|Least Squares Mean
2682891|NCT01380327|Primary|Change in German Cockroach-Specific Serum IgE Over Time|Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 3 months of treatment|Intent-to-treat population with complete data.|||Ratio||95% Confidence Interval|Geometric Mean
2682892|NCT01380197|Secondary|Number of Participants Who Experienced Pain Relief||2 days||||participants|||Number
2682893|NCT01380197|Primary|Acute Chest Syndrome|Number of Participants with Acute Chest Syndrome or A new pulmonry infiltrate on Chest X-ray|3 days||||participants|||Number
2682863|NCT01380691|Secondary|Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Episodic Memory|"Episodic memory is based on how accurate the participant responds using the measures from immediate word recall (range 0-15), delayed word recall (range 0-15), word recognition (range 0-15), and picture recognition (range 0-20) tasks. The sum of four the accuracy scores, are summed, and averaged to provide a composite score (range 0-37.5). This composite score reflects the ability to store, hold, and retrieve information of an episodic nature (such as an event, a name, an object, a scene, or an appointment). A high score reflects someone able to recall memory for a prolonged period. A negative change from baseline reflects impairment compared to baseline.~LS mean was calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect."|Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours|Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable episodic memory data.|||units on a scale||95% Confidence Interval|Geometric Mean
2682864|NCT01380691|Secondary|Change From Baseline to 1, 2, 3, 4.5, 6, 8, and 10 Hours in Working Memory|"Working memory is a sum of accuracy measures from the numeric and spatial working memory tasks known as the sensitivity index (SI). Working Memory SI is based on how fast the participant responds correctly and how many are correct responses. SI ranging from zero (chance performance) to one (perfect accuracy). A high score reflects someone able to hold in memory for a prolonged period. A negative change from baseline reflects impairment compared to baseline.~A series of 5 digits were presented on a computer screen, every second, for the participant to hold in memory. Followed by 30 probe digits, the participant had to decide whether it appeared in the original series by responding with 'Yes' or 'No'. This was repeated 2 times using different series and probes.~LS mean was calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect."|Baseline, 1, 2, 3, 4.5, 6, 8, and 10 hours|Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable working memory data.|||Units on a scale||95% Confidence Interval|Least Squares Mean
2682865|NCT01380691|Secondary|Pharmacokinetics: Area Under the Concentration Time Curve From Time Zero to the Last Time Point With a Measurable Concentration (AUC[0-tlast]) of Alcohol||Predose through 12 hours postdose|Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching LY2216684 with evaluable alcohol-concentration data.|||millimoles*hours/liters (mmol*h/L)||Geometric Coefficient of Variation|Geometric Mean
2682866|NCT01380691|Secondary|Pharmacokinetics: Area Under the Concentration Time Curve Over a Dosing Interval (AUCt) of LY2216684||Predose through 24 hours postdose|Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching alcoholic beverage with evaluable LY2216684-concentration data.|||nanograms*hours/milliliters (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2682867|NCT01380691|Secondary|Pharmacokinetics: Observed Tmax of Alcohol||Predose through 24 hours postdose|Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching LY2216684 with evaluable alcohol-concentration data.|||hours||Inter-Quartile Range|Median
2682868|NCT01380691|Secondary|Pharmacokinetics: Observed Time to Maximum Plasma Concentration (Tmax) of LY2216684||Predose through 24 hours postdose|Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching alcoholic beverage with evaluable LY2216684-concentration data.|||hours||Inter-Quartile Range|Median
2682869|NCT01380691|Secondary|Pharmacokinetics: Observed Cmax of Alcohol||Predose through 24 hours postdose|Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching LY2216684 with evaluable alcohol-concentration data.|||millimoles/liters (mmol/L)||Geometric Coefficient of Variation|Geometric Mean
2682870|NCT01380691|Secondary|Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax) of LY2216684||Predose through 24 hours postdose|Participants who received at least one dose of LY2216684, alcoholic beverage, or placebo-matching alcoholic beverage with evaluable LY2216684-concentration data.|||nanograms/milliliters (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2682871|NCT01380691|Primary|Change From Baseline to 10 Hours in Self-Rated Alertness|Assessed via the Bond and Lader Visual Analogue Scale (VAS), which utilizes a 16-point scale of 0 to 100 with 0 representing the worst rating and 100 representing the best rating. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect.|Baseline, 10 hours|Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable self-rated alertness data.|||units on a scale||95% Confidence Interval|Least Squares Mean
2682872|NCT01380691|Primary|Change From Baseline to 10 Hours in Postural Stability|"The ability to stand upright without moving was assessed using equipment modeled on the Wright Ataxia-meter. To measure movements, a cord was attached to the participant who was required to stand for one minute, as still as possible, with feet apart and eyes closed. The amount of sway is expressed as the total angular movement calibrated in units of one-third degree of angle of sway.~The amount of sway is expressed as the total angular movement in the antero-posterior plane and calibrated in units of one-third degree of angle of sway. Higher result indicates better postural stability. A negative change from baseline reflects impairment compared to baseline. LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect."|Baseline, 10 hours|Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable postural stability data.|||1/3 degree of angle of sway||95% Confidence Interval|Least Squares Mean
2682912|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2684424|NCT01368081|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|Number of patients with confirmed hypoglycaemic adverse events|After the first drug intake until 7 days after the last treatment administration, up to 383 days|Treated patients|||participants|||Number
2682873|NCT01380691|Primary|Change From Baseline to 10 Hours in Continuity of Attention Composite Score|"Continuity of attention is a measure of sustained attention, combining (summed) accuracy and error measures from the choice reaction time and digit vigilance tasks. The number of correct responses (out of 50) for choice reaction time was added to the total number of targets correctly identified (out of 45) digit vigilance minus the number of false alarms (total score of -45 to 95). A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline.~LS means were calculated using mixed model ANCOVA adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect."|Baseline, 10 hours|Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable continuity of attention data.|||units on a scale||95% Confidence Interval|Least Squares Mean
2682874|NCT01380691|Primary|Change From Baseline to 10 Hours in Power of Attention Composite Score|Power of attention is a measure of focused attention and information processing speed; based on the summed reaction times from the simple reaction time, choice reaction time, and digit vigilance tasks. Scores are measured by response latencies, and smaller scores indicate better function. Least squares (LS) means were calculated using mixed model analysis of covariance (ANCOVA) adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect.|Baseline, 10 hours|Participants who received at least one dose of LY2216684, alcoholic beverage, placebo-matching LY2216684, or placebo-matching alcoholic beverage with evaluable power of attention data.|||minutes||95% Confidence Interval|Least Squares Mean
2682875|NCT01380639|Secondary|Brain Natruretic Peptide (BNP)|change in BNP from baseline to day 19|day 1, day 19|||||||
2682876|NCT01380639|Secondary|Arterial Blood Gas||day 1|||||||
2682877|NCT01380639|Secondary|Lung Function||day 1|||||||
2682878|NCT01380639|Secondary|BODE-Score|Change in Bode-Score from baseline to day 19|day 1, day 19|||||||
2682879|NCT01380639|Secondary|Isometric Maximum Handgrip Force|change in isometric max. handgrip force from baseline to day 19|day 1, day 19|||||||
2682880|NCT01380639|Secondary|Body Composition|Change in body composition from baseline to day 19|day 1 and 19|||||||
2682881|NCT01380639|Primary|6-Minute-Walking-Distance|Change in 6-minute-walking-distance from baseline to day 19|day 1, day 19||||m||Standard Deviation|Mean
2682882|NCT01380535|Primary|Number of Participants With an Overall Response at Week 28|Participants with overall response included those with partial response or complete response, according to study staff who did not know which treatment they received (blinded assessment).|Week 28|Intention to treat population|||Participants|||Count of Participants
2682883|NCT01380379|Secondary|Change in Assertiveness Between Baseline and Post-intervention|"Measured by the Rathus Assertiveness Schedule (Rathus, 1973). Rathus Assertiveness Scale is a 30-item scale assessing assertive behavior in a variety of situations. Each item is rated on a 6-point Likert scale from +3 (very characteristic of me) to -3 (very uncharacteristic of me). Total scores range from +90, which is equivalent of very assertive behavior to -90, which is equivalent to very unassertive behavior.~The positive change indicates an increase in assertive behavior."|Change in assertiveness from baseline to post-class (8 weeks)||||units on a scale||Standard Deviation|Mean
2682884|NCT01380379|Primary|Change in Self-efficacy From Baseline to Post-treatment|General self-efficacy (Schwartz and Jerusalem, 1993) is a measure of one's perceived self-competence. Scores are summed across 10 items, and range between 10-40, where higher scores reflect a stronger sense of personal competence.|Change in GSE from baseline to 8 weeks|The data is the change in general self efficacy from baseline to post-class, with higher scores indicating a greater increase in self-efficacy|||units on a scale||Standard Deviation|Mean
2682885|NCT01380366|Secondary|To Evaluate Liver Enzymes in Total Parenteral Nutrition (TPN)-Dependent Short Bowel Syndrome Patients Before and After Administration of Zorbtive®.|Following completion of Visit 2, study staff will obtain results of liver injury/function tests (ALT, Aspartate transaminase (AST), bilirubin, alkaline phosphatase (ALK or ALP), GGT) from the medical record from each routine clinical exam from Month 3 through Month 24. Results that show decreased liver injury (ALT, AST, bilirubin, alkaline phosphate (ALK or ALP), GGT) will show Zorbtive administration enhanced intestinal permeability and enhanced liver function.|(Visit 1) Baseline, (Visit 2) 28-31 days after baseline, then at regularly scheduled follow-up clinic visits for two years from Month 3 through Month 24||||participants|||Number
2682886|NCT01380366|Primary|To Identify Small Intestinal Permeability Changes in Short Bowel Syndrome Patients After Administration of Recombinant Human Growth Hormone (Zorbtive®).|Permeability changes will be identified in short bowel syndrome patients by evaluating concentration of lactulose, mannitol and sucralose from Visit 1 to Visit 2. A decrease in concentration of sucralose in urine indicates Zorbtive potentially enhancing intestinal barrier function.|(Visit 1) Baseline to (Visit 2) 28-31 days after baseline||||participants|||Number
2682887|NCT01380327|Secondary|Percent of Participants With the Occurrence of Adverse Events (AEs)|Percent of participants who experienced at least one AE.|Participant enrollment to end of study (up to 3 months post-baseline)||||Percentage of population|||Number
2682888|NCT01380327|Secondary|Change in IgE Fragment Antibody Binding (FAB) Activity Over Time|Outcome is change in mean IgE FAB activity level from baseline to post-baseline (status post 3 months of treatment). Serum from cockroach sublingual immunotherapy (SLIT)-treated participants were analyzed to determine if treatment inhibits in-vitro cockroach SLIT, using the per protocol allergenic extract doses. This result is an indicator of immune modulation over time, however its clinical significance is unclear.(Reference: Shamji MH et al. The IgE-facilitated allergen binding (FAB) assay: validation of a novel flow-cytometric based method for the detection of inhibitory antibody responses. J Immunol Methods 2006;317(1-2): 71-9).|Baseline through 3 months of treatment|Intent-to-treat population with complete data.|||Percent antibody binding||95% Confidence Interval|Mean
2682889|NCT01380327|Secondary|Change in German Cockroach-Specific Serum IgG4 Over Time|Outcome is the ratio of geometric means for baseline versus post-baseline German cockroach-specific serum immunoglobulin subclass 4 (IgG4). This result is an indicator of immune modulation over time, however its clinical significance is unclear.|Baseline through 3 months of treatment|Intent-to-treat population with complete data.|||Ratio||95% Confidence Interval|Geometric Mean
2682894|NCT01380184|Primary|Apparent Terminal Half-life (t1/2) of Ridaforolimus: Cycle 1 (Cycle 1 is 19 Days)|t½ is the time that it takes for the concentration of ridaforolimus in the body to decrease by half. The (harmonic) means and 95% confidence intervals for t1/2 after a single dose of ridaforolimus and after multiple doses of ridaforolimus are presented.|Cycle 1: Predose on Day 1 and at various time points through to 24 hours postdose on Day 19; Cycle 1 is 19 days|The Pharmacokinetic Evaluable population consisted of all participants who complied with the protocol sufficiently to ensure that these data will likely exhibit the effects of treatment according to the underlying scientific model and who had blood samples with concentrations above the lower limit of quantitation.|||Hours||95% Confidence Interval|Mean
2682895|NCT01380184|Primary|Time to Maximum Concentration (Tmax) of Ridaforolimus: Day 1, Day 19|Tmax is the time at which the Cmax of ridaforolimus is reached. The medians and ranges (minimum, maximum) for Tmax after a single dose of ridaforolimus and after multiple doses of ridaforolimus are presented.|Cycle 1 Day 1: Predose and at various time points up to 24 hours postdose on Day 1; Cycle 1 Day 19: Predose and at various time points up to 24 hours postdose on Day 19; Cycle 1 is 19 days|The Pharmacokinetic Evaluable population consisted of all participants who complied with the protocol sufficiently to ensure that these data will likely exhibit the effects of treatment according to the underlying scientific model and who had blood samples with concentrations above the lower limit of quantitation.|||Hours||Full Range|Median
2682896|NCT01380184|Primary|Concentration at 24 Hours (C24hr) of Ridaforolimus: Day 1, Day 19|C24hr is the concentration of ridaforolimus in the blood 24 hours after a dose of ridaforolimus. The (geometric) mean was calculated based on the back-transformed least-squares mean and the 95% confidence interval was determined from a linear mixed-effect model, containing a fixed effect for day and a random effect for participant, performed on natural log-transformed values. The geometric means and back-transformed 95% confidence intervals after a single dose of ridaforolimus and after multiple doses of ridaforolimus are presented for C24hr.|Cycle 1 Day 1: Predose and at various time points up to 24 hours postdose on Day 1; Cycle 1 Day 19: Predose and at various time points up to 24 hours postdose on Day 19; Cycle 1 is 19 days|The Pharmacokinetic Evaluable population consisted of all participants who complied with the protocol sufficiently to ensure that these data will likely exhibit the effects of treatment according to the underlying scientific model and who had blood samples with concentrations above the lower limit of quantitation.|||ng/mL||95% Confidence Interval|Geometric Mean
2682897|NCT01380184|Primary|Maximum Concentration (Cmax) of Ridaforolimus: Day 1, Day 19|Cmax is the peak blood plasma concentration following a dose of ridaforolimus. The (geometric) mean was calculated based on the back-transformed least-squares mean and the 95% confidence interval was determined from a linear mixed-effect model, containing a fixed effect for day and a random effect for participant, performed on natural log-transformed values. The geometric means and back-transformed 95% confidence intervals after a single dose of ridaforolimus and after multiple doses of ridaforolimus are presented for Cmax.|Cycle 1 Day 1: Predose and at various time points up to 24 hours postdose on Day 1; Cycle 1 Day 19: Predose and at various time points up to 24 hours postdose on Day 19; Cycle 1 is 19 days|The Pharmacokinetic Evaluable population consisted of all participants who complied with the protocol sufficiently to ensure that these data will likely exhibit the effects of treatment according to the underlying scientific model and who had blood samples with concentrations above the lower limit of quantitation.|||ng/mL||95% Confidence Interval|Geometric Mean
2682898|NCT01380184|Primary|Area Under the Curve From 0 to 24 Hours (AUC0-24hr) of Ridaforolimus: Day 1, Day 19|AUC0-24hr represents the total exposure to ridaforolimus and its average blood concentration multiplied by the total amount of time (extrapolated to 24 hours) that ridaforolimus was in the body. The (geometric) mean was calculated based on the back-transformed least-squares mean and the 95% confidence interval was determined from a linear mixed-effect model, containing a fixed effect for day and a random effect for participant, performed on natural log-transformed values. The geometric means and back-transformed 95% confidence intervals after a single dose of ridaforolimus and after multiple doses of ridaforolimus are presented for AUC0-24hr.|Cycle 1 Day 1: Predose and at various time points up to 24 hours postdose on Day 1; Cycle 1 Day 19: Predose and at various time points up to 24 hours postdose on Day 19; Cycle 1 is 19 days|The Pharmacokinetic Evaluable population consisted of all participants who complied with the protocol sufficiently to ensure that these data will likely exhibit the effects of treatment according to the underlying scientific model and who had blood samples with concentrations above the lower limit of quantitation.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2682899|NCT01380184|Primary|Area Under the Curve From 0 to Infinity (AUC0-∞) of Ridaforolimus: Cycle 1 (Cycle 1 is 19 Days)|AUC0-∞ represents the total exposure to ridaforolimus and its average blood concentration multiplied by the total amount of time (extrapolated to infinity) that ridaforolimus was in the body. The (geometric) mean was calculated based on the back-transformed least-squares mean and the 95% confidence interval was determined from a linear mixed-effect model, containing a fixed effect for day and a random effect for participant, performed on natural log-transformed values. The geometric mean and back-transformed 95% confidence interval are presented for AUC0-∞.|Cycle 1: Predose on Day 1 and at various time points through to 24 hours postdose on Day 19; Cycle 1 is 19 days|The Pharmacokinetic Evaluable population consisted of all participants who complied with the protocol sufficiently to ensure that these data will likely exhibit the effects of treatment according to the underlying scientific model and who had blood samples with concentrations above the lower limit of quantitation.|||ng*hr/mL||95% Confidence Interval|Geometric Mean
2682900|NCT01380184|Primary|Lag Time (Tlag) of Ridaforolimus: Day 1|Tlag is the time taken for ridaforolimus to appear in systemic circulation following oral administration. The median and full range (minimum, maximum) for Tlag after a single dose of ridafolorlimus are presented.|Cycle 1 Day 1: Predose and at various time points up to 24 hours postdose on Day 1; Cycle 1 is 19 days|The Pharmacokinetic Evaluable population consisted of all participants who complied with the protocol sufficiently to ensure that these data will likely exhibit the effects of treatment according to the underlying scientific model and who had blood samples with concentrations above the lower limit of quantitation.|||Hours||Full Range|Median
2682913|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682901|NCT01380184|Secondary|Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)|A laboratory AE (LAE) is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A clinical AE (CAE) is defined similarly but also includes changes in structure or function of the body. Serious AEs (SAEs) are those that result in one or more of the pre-specified outcome(s) that meet the criteria of seriousness, including death, life-threatening, significant disability, or hospitalization, etc. Drug-relatedness was determined by the investigator based on clinical judgement.|From first dose up to 30 days after last dose (Up to 26 weeks)|The Safety Population consisted of all participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2682902|NCT01380145|Secondary|Assessment of Survival and Time to Subsequent Therapy|Progression-free survival (PFS) was calculated as the date from first immunization to first observation of disease progression or death due to any cause, censored on the start date of subsequent therapy or at the last date of disease assessment for subjects without a PFS event. Overall survival (OS) was calculated as the date from first immunization to death due to any cause, censored at the date of last follow-up for subjects who were alive at the time of the analysis. Time to subsequent therapy was calculated as the date from first immunization to start of subsequent therapy for myeloma, censored at the date of death or last follow-up for subjects who did not receive subsequent therapy.|Continuously on study and for up to 5 years post-study|The Evaluable Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.|||days||Full Range|Median
2682903|NCT01380145|Secondary|Assessment of Tumor Response|"Tumor responses were evaluated using appropriate imaging methods and were categorized according to the IMWG criteria, which includes the following response designations:~Complete Response (CR): negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, <5% plasma cells in bone marrow; Stringent CR (sCR): CR + normal free light chain (FLC) ratio and absence of clonal cells in bone marrow; Very Good Partial Response (VGPR): Serum/urine M-component detectable by immunofixation but not electropheresis OR ≥90% reduction in serum M-component + urine M-component <100 mg/24 hrs; Partial Response (PR): ≥50% reduction of serum M-protein and reduction in 24-hr urinary M-protein by ≥90% or to <200 mg/24 hrs Stable disease: not response or progression"|At 3 and 12 months after auto-SCT|The Evaluable Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.|||participants|||Number
2682904|NCT01380145|Secondary|Induction or Augmentation of MAGE-A3-Specific Cellular Immunity|Cellular immunity was determined by enzyme-linked immunosorbent spot assay (ELISPOT) or intracellular flow cytometry to determine peripheral blood levels of interferon gamma-producing CD4+ and CD8+ T cells specific for MAGE-A3. Results were considered significant if > 50 spots and > 2 times the number of spots to negative control were observed.|Baseline, first immunization, and first and second leukopheresis prior to auto-SCT; Days 31, 73, 194, 284, and 374 after auto-SCT|The Immunogenicity Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.|||participants|||Number
2682905|NCT01380145|Secondary|Induction or Augmentation of MAGE-A3-Specific Humoral Immunity|Humoral immunity was determined by enzyme-linked immunosorbent assay (ELISA) to measure the presence of circulating antibodies to MAGE-A3. Titers against an antigen were considered significant if they were >100. Induction of responses was considered significant if there was a change from undetectable (<100) to detectable (>100) or if there was an at least 4-fold increase in titers over time.|Baseline, first immunization, and first and second leukopheresis prior to auto-SCT; Days 31, 73, 194, 284, and 374 after auto-SCT|The Immunogenicity Analysis Set comprises all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.|||participants|||Number
2682906|NCT01380145|Primary|Assessment of Safety of recMAGE-A3 + AS15|Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs, with severity graded according to the NCI CTCAE, Version 4.0.|Continuously for up to 14 months|The Safety Analysis Set comprises all subjects who received at least 1 immunization with study drug.|||participants|||Number
2682907|NCT01380093|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682908|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682909|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682910|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682911|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone Metabolite (6-beta-naltrexol)|AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682916|NCT01380093|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682917|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Naltrexone|AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682918|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Naltrexone|AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682919|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Naltrexone|AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682920|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Naltrexone|AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682921|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Naltrexone|AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682922|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Naltrexone|AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682923|NCT01380093|Secondary|Maximum Observed Plasma Concentration (Cmax) of Naltrexone||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||pg/mL||Standard Deviation|Mean
2682924|NCT01380093|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs||Standard Deviation|Mean
2682925|NCT01380093|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Morphine|AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682926|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)] of Morphine|AUC (0-24) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682927|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-12)] of Morphine|AUC (0-12) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682928|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-8)] of Morphine|AUC (0-8) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682929|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-4)] of Morphine|AUC (0-4) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682930|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-2)] of Morphine|AUC (0-2) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682931|NCT01380093|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-1)] of Morphine|AUC (0-1) = Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||hrs*pg/mL||Standard Deviation|Mean
2682932|NCT01380093|Secondary|Maximum Observed Plasma Concentration (Cmax) of Morphine||Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|Safety population included all participants who received at least one dose of study drug in the Treatment Phase.|||picogram/milliliter (pg/mL)||Standard Deviation|Mean
2682934|NCT01380093|Secondary|Pupillometry: Time to Maximum (Peak) Effect (TEmax)|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. TEmax = Time to smallest post-dose pupil size.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
2682935|NCT01380093|Secondary|Pupillometry: Peak Effect (Emax)|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. Emax = Smallest post-dose pupil size.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
2682936|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-24 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682937|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-12 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682938|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-8 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682939|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-4 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682940|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-2 Hours|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682941|NCT01380093|Secondary|Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour|Pupillometry assessments measured change in pupil size (miosis) as an indicator of opioid pharmacological properties. The same eye for each participant was used for all measurements during the study. Participants had the size of their pupil measured (in mm) using a pupillometer. Measurements were made in a dimly lit (mesopic) room with controlled lighting conditions. AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682942|NCT01380093|Secondary|Take Drug Again Effect at 24 Hours|"Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = definitely would not, 50 mm = do not care, and 100 mm = definitely would)."|24 hrs post dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
2683072|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|9 months|Change from baseline analysis is based on last observation carried forward for total study population (N=1341) and tablet formulation group (N=677).|||Log10 copies per ml||Standard Deviation|Mean
2682943|NCT01380093|Secondary|Overall Drug Liking Effect at 24 Hours|"Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = strong disliking, 50 mm= neither like nor dislike, and 100 mm= strong liking)."|24 hrs post dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
2682944|NCT01380093|Secondary|Dizzy: Time to Maximum (Peak) Effect (TEmax)|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
2682945|NCT01380093|Secondary|Dizzy: Peak Effect (Emax)|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
2682946|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-24 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682947|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-12 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682948|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-8 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682949|NCT01380093|Primary|High: Peak Effect (Emax)|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
2682950|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-4 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682951|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-2 Hours|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682952|NCT01380093|Secondary|Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour|Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682953|NCT01380093|Secondary|Sleepy: Time to Maximum (Peak) Effect (TEmax)|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
2683024|NCT01380080|Secondary|CD4+ T-cell Count Change From Baseline|Change was calculated as the CD4+ T-cell count at week (4 and 24) minus the baseline CD4+ T-cell count. The results at week 48 will be submitted after the study is completed|From study entry to weeks 4, 24 and 48|Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.|||cells/ mm^3||Inter-Quartile Range|Median
2682954|NCT01380093|Secondary|Sleepy: Peak Effect (Emax)|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
2682955|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-24 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682956|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-12 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682957|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-8 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682958|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-4 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682959|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-2 Hours|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682960|NCT01380093|Secondary|Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour|Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr(0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682961|NCT01380093|Secondary|Feel Sick: Time to Maximum (Peak) Effect (TEmax)|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
2682962|NCT01380093|Secondary|Feel Sick: Peak Effect (Emax)|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
2682963|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-24 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682964|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-12 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2683025|NCT01380080|Secondary|CD4+ T-cell Count|The absolute levels of CD4+ T-cell counts (cells/mm^3) at weeks 0, 4, and 24. The results at week 48 will be submitted after the study is completed|At weeks 0, 4, 24, and 48|Intent to treat: All eligible participants were included in the analysis: Participants were analyzed per original assigned randomized treatment. Missing data were assigned missing completely at random.|||cells/ mm^3||Inter-Quartile Range|Median
2682965|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-8 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682966|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-4 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682967|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-2 Hours|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682968|NCT01380093|Secondary|Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour|Feel sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682969|NCT01380093|Secondary|Nausea: Time to Maximum (Peak) Effect (TEmax)|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
2682970|NCT01380093|Secondary|Nausea: Peak Effect (Emax)|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
2682971|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-24 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682972|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-12 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682973|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-8 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682974|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-4 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|Pre-dose, 0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682975|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-2 Hours|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|Pre-dose, 0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2683073|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|6 months||||Log10 copies per ml||Standard Deviation|Mean
2682976|NCT01380093|Secondary|Nausea: Area Under Effect Curve (AUE) From 0-1 Hour|Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|Pre-dose, 0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682977|NCT01380093|Secondary|Bad Effects: Time to Maximum (Peak) Effect (TEmax)|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
2682978|NCT01380093|Secondary|Bad Effects: Peak Effect (Emax)|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
2682979|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-24 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682980|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-12 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682981|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-8 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682982|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-4 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682983|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-2 Hours|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682984|NCT01380093|Secondary|Bad Effects: Area Under Effect Curve (AUE) From 0-1 Hour|Bad effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682985|NCT01380093|Secondary|Any Effects: Time to Maximum (Peak) Effect (TEmax)|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
2682986|NCT01380093|Secondary|Any Effects: Peak Effect (Emax)|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
2683074|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|3 months||||Log10 copies per ml||Standard Deviation|Mean
2682987|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-24 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682988|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-12 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682989|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-8 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682990|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-4 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682991|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-2 Hours|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682992|NCT01380093|Secondary|Any Effects: Area Under Effect Curve (AUE) From 0-1 Hour|Any effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682993|NCT01380093|Secondary|Good Effects: Time to Maximum (Peak) Effect (TEmax)|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
2682994|NCT01380093|Secondary|Good Effects: Peak Effect (Emax)|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
2682995|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-24 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682996|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-12 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682997|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-8 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2683075|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|1 month||||Log10 copies per ml||Standard Deviation|Mean
2682998|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-4 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2682999|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-2 Hours|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2683000|NCT01380093|Secondary|Good Effects: Area Under Effect Curve (AUE) From 0-1 Hour|Good effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2683001|NCT01380093|Secondary|High: Time to Maximum (Peak) Effect (TEmax)|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). TEmax = Time to maximum observed score.|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
2683002|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-24 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24).|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2683003|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-12 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12).|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2683004|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-8 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8).|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2683005|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-4 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4).|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2683006|NCT01380093|Secondary|High: Area Under Effect Curve (AUE) From 0-1 Hour|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1).|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2683007|NCT01380093|Secondary|Drug Liking: Time to Maximum (Peak) Effect (TEmax)|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). TEmax = Time to maximum observed score."|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs||Standard Deviation|Mean
2683008|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-24 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-24) = Area under the effect versus time curve from time 0 to 24 hrs (0-24)."|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2683009|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-12 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-12) = Area under the effect versus time curve from time 0 to 12 hrs (0-12)."|0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2683010|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-8 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-8) = Area under the effect versus time curve from time 0 to 8 hrs (0-8)."|0.5, 1, 1.5, 2, 3, 4, 6 and 8 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2683011|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-4 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-4) = Area under the effect versus time curve from time 0 to 4 hrs (0-4)."|0.5, 1, 1.5, 2, 3 and 4 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2683012|NCT01380093|Secondary|Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-1) = Area under the effect versus time curve from time 0 to 1 hr (0-1)."|0.5 and 1 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2683013|NCT01380093|Primary|High: Area Under Effect Curve (AUE) From 0-2 Hours|High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hrs (0-2).|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2683014|NCT01380093|Primary|Drug Liking: Peak Effect (Emax)|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). Emax = Maximum observed score."|0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose PD data from each period and did not have major protocol violations.|||mm||Standard Deviation|Mean
2683015|NCT01380093|Primary|Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hours|"Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of neither like nor dislike (score of 50 mm), on the left with strong disliking (score of 0 mm) and on the right with strong liking (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours (hrs) (0-2)."|0.5, 1, 1.5 and 2 hrs post-dose|The evaluable population included all randomized participants who completed all 3 treatment periods of the treatment phase, contributed post-dose pharmacodynamic (PD) data from each period and did not have major protocol violations.|||hrs*mm||Standard Deviation|Mean
2683016|NCT01380080|Secondary|Proportion of Participants Who Prematurely Discontinued Antiretroviral Therapy by Week 48|Proportion of participants with premature discontinuation of antiretroviral therapy (ART) by Week 48|From study entry to week 48||2020-12-31|12/2020||||
2683017|NCT01380080|Secondary|Proportion of Participants Who Prematurely Discontinued Any Component of TB Treatment by Week 48|Proportion of participants with premature discontinuation of any component of TB treatment by Week 48|From study entry to week 48||2020-12-31|12/2020||||
2683018|NCT01380080|Secondary|Proportion of Participants With Reportable Hospitalization by Week 48|Proportion of participants with any hospitalization reported by Week 48|From study entry to week 48||2020-12-31|12/2020||||
2683019|NCT01380080|Secondary|Proportion of Participants With IRIS (Using Current ACTG Definition) by Week 48|Proportion of participants with IRIS (using current ACTG definition Appendix 60) by Week 48|From study entry to week 48||2020-12-31|12/2020||||
2683020|NCT01380080|Secondary|Proportion of Participants With at Least One New Grade 3 or 4 That is at Least a One-grade Increase From Baseline for the Following Targeted Laboratory Values by Week 48|"Proportion of participants with at least one new Grade 3 or 4 that is at least a one-grade increase from baseline for the following targeted laboratory values by Week 48~The targeted laboratory events include hemoglobin, serum creatinine, ALT and AST"|From study entry to week 48||2020-12-31|12/2020||||
2683021|NCT01380080|Secondary|Proportion of Participants With at Least One New Grade 3 or 4 Adverse Event That is at Least a One-grade Increase From Baseline by Week 48|Proportion of participants with at least one new Grade 3 or 4 laboratory or sign or symptom that is at least a one-grade increase from baseline by Week 48|From study entry to week 48||2020-12-31|12/2020||||
2683026|NCT01380080|Secondary|Proportion of Participants With HIV-1 RNA Level <400 Copies/mL|Proportion of participants with HIV-1 RNA level <400 copies/mL at weeks 0, 4, and 24. The results at week 48 will be submitted after the study is completed|At weeks 0, 4, 24, and 48|Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completed at random|||Proportion of participants||95% Confidence Interval|Number
2683027|NCT01380080|Secondary|Cumulative Probability of Death or AIDS Progression by Week 24|"The Kaplan-Meier estimate of the cumulative probability of death or AIDS progression by week 24~The result of cumulative probability of death or AIDS progression by week 48 will be submitted after the study is completed. AIDS progression was defined as new WHO stage 3 or 4 conditions occurred after study entry."|From study entry to week 24|Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment|||Cumulative probablity per 100 persons||95% Confidence Interval|Number
2683028|NCT01380080|Secondary|Cumulative Probability of First AIDS Progression by Week 96|The Kaplan-Meier estimate of the cumulative probability of first AIDS progression which was defined as the identification of a new World Health Organization (WHO) stage 3 or 4 condition|From study entry to week 96||2020-12-31|12/2020||||
2683029|NCT01380080|Secondary|Cumulative Probability of Death by Week 24|The Kaplan-Meier estimate of cumulative probability of death by week 24|From study entry to week 24|Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment|||Cumulative probablity per 100 persons||95% Confidence Interval|Number
2683030|NCT01380080|Primary|Cumulative Probability of Death or Unknown Vital Status by Week 24|"The Kaplan-Meier estimate of the cumulative probability of death or unknown vital status by week 24.~Vital status at week 48 and again at weeks 60, 72, 84, and 96 was determined for participants who do not complete study follow-up, including those who are prematurely discontinued from the study before week 24 without coming in to the clinic. Vital status for participants who are not discontinued from the study whenever a scheduled visit of any type is missed was also obtained. The vital status was considered unknown at week 24 if a participant prematurely discontinued from the study before week 24 and no vital status was obtained at week 48."|From study entry to week 24|Intent to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment|||Cumulative probablity per 100 persons||95% Confidence Interval|Number
2683031|NCT01379963|Secondary|Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL|Hemoglobin level Level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to KDOQI guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.|Up to 6 months|Analysis population included all enrolled participants who had received study treatment and were monitored for hemoglobin level on a monthly basis, according to standard clinical practice. Here, number of participants analyzed signifies those participants who were evaluable for this outcome.|||Percentage of participants|||Number
2683032|NCT01379963|Primary|Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL)|Hemoglobin level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.|Up to 6 months|Analysis population included all enrolled participants who had received study treatment and were monitored for hemoglobin level on a monthly basis, according to standard clinical practice. Here, number of participants analyzed signifies those participants who were evaluable for this outcome.|||Percentage of participants|||Number
2683033|NCT01379937|Secondary|Number of Subjects With Booster Vaccine Response for H5N1 Neutralizing Antibodies|This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.|At Days 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Subjects|||Number
2683034|NCT01379937|Secondary|Number of Subjects With Vaccine Response Rates (VRR) for H5N1 Neutralizing Antibodies||At Days 42, 182 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Subjects|||Number
2683035|NCT01379937|Secondary|Number of Subjects With Neutralizing Anti-H5N1 Antibody Titers|"Seropositivity rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.~Seropositivity rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 0, 42,182, 192 and 364."|At Days 0, 42, 182 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Subjects|||Number
2683036|NCT01379937|Secondary|Booster Factor for Hemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/01/2005 Strain of H5N1 Influenza Disease|Boooster factor against the A/turkey/Turkey/01/2005 (H5N1 VIRUS) strain were tabulated 95% CI on Days 192,364. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.|At Days 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Titer||95% Confidence Interval|Geometric Mean
2689506|NCT01326845|Secondary|Difference in Frequency and Severity of All Non-GI AEs Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|months 3 and 6|||||||
2683037|NCT01379937|Secondary|Number of Seroconverted Subjects Against the A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease|"Booster seroconversion rates against the A/turkey/Turkey/01/2005 (H5N1 VIRUS) strain were tabulated on Days 192 and 364.~This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol."|At Days 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Subjects|||Number
2683038|NCT01379937|Secondary|Mean Geometric Increase for Anti-H5N1 Antibody Titers|"MGI against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.~MGI against the A/turkey/Turkey/01/2005 (H5N1 virus) strain were tabulated on Days 42, 182 and 364."|At Days 42, 182, 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Titer||95% Confidence Interval|Geometric Mean
2683039|NCT01379937|Secondary|Number of Seroprotected Subjects Against the A/Indonesia/05/2005 and A/Turkey/Turkey/01/2005 Strains of H5N1 Influenza Disease|"A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.~Seroprotection rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated 95% CI on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 -Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.~Seroprotection rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 182 and 192."|At Days 0,42, 182, 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Subjects|||Number
2683040|NCT01379937|Secondary|Number of Seroconverted Subjects Against the A/Indonesia/05/2005 Strains of H5N1 Influenza Disease|"A seroconverted subject was defined as a vaccinee with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.~Seroconversion rates against the A/Indonesia/05/2005 (H5N1 VIRUS) strain were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group."|At Days 42, 182, 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Subjects|||Number
2683041|NCT01379937|Secondary|Number of Subjects With Anti-H5N1 Antibodies Above the Cut Off Values ≥1:10|"Seropositivity rates against the A/Indonesia/5/2005 (H5N1 virus) strain, were tabulated on Days 0,42,182 for all subjects, 192 for GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and 364 for GSK1562902A Formulation 1 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group.~Seropositivity rates against the A/turkey/Turkey/01/2005 (H5N1 virus) strain, were tabulated on Days 182, 192 and 364."|At Days 0, 42, 182, 192 and 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Subjects|||Number
2683042|NCT01379937|Secondary|Number of Subjects With Serious Adverse Events (SAEs).|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (Day 0 to 364)|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2683043|NCT01379937|Secondary|Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)||During the entire study period (Day 0 to 364)|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2683044|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During Day 0 to Telephone Contact (TC) Day 84 overall.|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2683055|NCT01379768|Primary|Change From Week 1 in Relative Oxidative Response of PMNs at Week 5|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.|Week 1, Week 5|This reporting group includes all participants who completed the study per protocol.|||Ratio||Standard Deviation|Mean
2684452|NCT01367860|Secondary|VAS for Leg Pain - 1st Week|Pain Score for leg pain- Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|1st week from surgery||||units on a scale||Standard Deviation|Mean
2683045|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.|During a 21-day (Days 0 - 20) follow-up period after vaccination|The analysis was based on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2683046|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia and temperature[defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. The symptoms were assessed for subjects aged 6 years or more.|During a 7-day (Day 0-6) follow-up period after vaccination|The analysis was based on subjects aged 6 years or more, comprised in the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2683047|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.|Assessed solicited general symptoms were diarrhea/vomiting, drowsiness, irritability/fussiness, loss of appetite and temperature [defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. The symptoms were assessed for subjects aged less than 6 years.|During a 7-day (Day 0-6) follow-up period after each vaccination|The analysis was based on subjects aged less than 6 years, comprised in the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2683048|NCT01379937|Secondary|Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.|During a 7-day (Day 0-6) follow-up period after each vaccination|The analysis was based on the Total vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2683049|NCT01379937|Secondary|H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains|Antibody titers were given as GMTs. A/Indonesia/5/2005 = A/INDO and A/Turkey/Turkey/01/2005 = A/TURK.|At Days 0, 42, 182, 192, 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Titer||95% Confidence Interval|Geometric Mean
2683050|NCT01379937|Secondary|H5N1 HI Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains|The antibody titres were given as Geometric Mean Titer (GMT). A/Indonesia/5/2005 = A/INDO and A/Turkey/Turkey/01/2005 = A/TURK.|At Days 0, 42, 182, 192, 364|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Titer||95% Confidence Interval|Geometric Mean
2683051|NCT01379937|Primary|Number of Subjects With Any Medically Attended Adverse Events (MAEs)|Any = occurrence of the symptom regardless of intensity grade.|From Day 0 to Day 364.|The analysis was based on the Total vaccinated Cohort, which included all subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2683052|NCT01379937|Primary|Number of Subjects With Any Medically Attended Adverse Events (MAEs)|Any = occurrence of the symptom regardless of intensity grade. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.|From Day 0 to Day 182|The analysis was based on the Total vaccinated Cohort, which included all subjects with at least 1 vaccine administration documented.|||Subjects|||Number
2683053|NCT01379937|Primary|Haemagglutination Inhibition (HI) Antibody Titers for the A/Turkey/Turkey/01/2005 (H5N1) Vaccine Strain.|Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Turkey/Turkey/01/2005 antigen. The A/Turkey/Turkey/01/2005 (A/TURK) vaccine strain was administered to groups receiving the adjuvanted Influenza vaccine GSK1562902A. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.|At Day 192.|The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) and for whom assay results were available for antibodies against the study vaccine.|||Titer||95% Confidence Interval|Geometric Mean
2683054|NCT01379781|Primary|Hamilton Rating Scales of Depression|"Assessing severity of depression; clinician rated~24 questions~13 items are scored on a 5 point scale ranging from 0=not present to 4=severe~11 items are scored from 0-2~A composite score is created by the sum of the scores from all items. Scores can range from 0-74~0-7: normal~8-13: mild depression~14-18: moderate depression~19-23: severe depression~24: very severe depression~Higher summed values indicate a greater severity of depression"|6 weeks postpartum|Those in the analysis received both baseline and 6-week assessment sessions.|||units on a scale||Standard Deviation|Mean
2683071|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|12 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.|||Log10 copies per ml||Standard Deviation|Mean
2683056|NCT01379768|Primary|Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Cell adhesion response is reported as a ratio of activated to non-activated samples. The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.|Week 1, Week 5|This reporting group includes all participants who completed the study per protocol.|||Ratio||Standard Deviation|Mean
2683057|NCT01379768|Primary|Change From Week 1 in Leukocyte Population at Week 5|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The difference between total leukocytes for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.|Week 1, Week 5|This reporting group includes all participants who completed the study per protocol.|||Leukocytes||Standard Deviation|Mean
2683058|NCT01379768|Primary|Relative Oxidative Response of Polymorphonuclear Leukocytes (PMNs)|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. Oxidative response is reported as a ratio of activated to non-activated samples. DCF (dichlorofluorescein diacetate) is a molecular probe that measures the oxidative burst. Upon stimulation, the PMNs synthesize reactive oxygen species, such as superoxide or hydrogen peroxide, which is detected by the probe. Differences in the oxidative response between contact lens wearers and non-lens wearers is indicated by a shift in the ratio (stimulated/unstimulated).|Week 5|This reporting group includes all participants who completed the study per protocol.|||Ratio||Standard Deviation|Mean
2683059|NCT01379768|Primary|Relative Cell Adhesion Response of Polymorphonuclear Leukocytes (PMNs)|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer. CD54 is a protein typically found in the cell membrane of leukocytes, which up-regulates during inflammation and promotes cell adhesion. Cell adhesion response is reported as a ratio of stimulated to non-stimulated samples.|Week 5|This reporting group includes all participants who completed the study per protocol.|||Ratio||Standard Deviation|Mean
2683060|NCT01379768|Primary|Leukocyte Population|A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA). Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes. The total amount of leukocytes for contact lens wearers and non-lens wearers is presented. Potential differences in leukocyte count between lens wearers and non-lens wearers may indicate a different immune response.|Week 5|This reporting group includes all participants who completed the study per protocol.|||Leukocytes||Standard Deviation|Mean
2683061|NCT01379703|Secondary|Adverse Events Observed on Treatment With Lopinavir/Ritonavir.|"Total number of adverse events with causal relationship (rated by Investigator as probably or possibly related) to lopinavir/ritonavir treatment.~All serious adverse events and non serious adverse events (0.2% or greater frequency) are summarized in the Reported Adverse Events section of this record."|18 months||||Events|||Number
2683062|NCT01379703|Secondary|Compliance With Lopinavir/Ritonavir|Participants reported whether they had missed any doses of their antiretroviral treatment.|18 months|Only participants receiving lopinavir/ritonavir capsules for followed for up to 18 months.|||Participants|||Number
2683063|NCT01379703|Secondary|Compliance With Lopinavir/Ritonavir|Participants reported whether they had missed doses of their antiretroviral treatment.|9 months||||Participants|||Number
2683064|NCT01379703|Secondary|Reasons for Discontinuation of Lopinavir/Ritonavir|For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.|18 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.|||Participants|||Number
2683065|NCT01379703|Secondary|Reasons for Discontinuation of Lopinavir/Ritonavir|For participants who discontinued lopinavir/ritonavir treatment, the reasons for discontinuation are provided.|9 months||||Participants|||Number
2683066|NCT01379703|Primary|Laboratory Parameter Lipids|A blood lipid panel consisting of total cholesterol, triglyceride, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) levels was performed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.|Baseline, 9 months, 18 months|Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.|||millimoles per liter||Standard Deviation|Mean
2683067|NCT01379703|Primary|Laboratory Parameter Transaminases|Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.|Baseline, 9 months, 18 months|Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.|||international units per liter||Standard Deviation|Mean
2683068|NCT01379703|Primary|Laboratory Parameter Blood Glucose|Blood glucose laboratory values were assessed at baseline and scheduled study visits. Normal ranges are based on the standards for individual facilities in each country.|Baseline, 9 months, 18 months|Analysis was based on participants with laboratory values at each time point. Only participants receiving lopinavir/ritonavir capsules were planned to be followed after 9 months.|||millimoles per liter||Standard Deviation|Mean
2683069|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|18 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on last observation carried forward (N=660).|||Log10 copies per ml||Standard Deviation|Mean
2683070|NCT01379703|Primary|Viral Load|Viral load (number of HIV-RNA copies in the blood) was measured at baseline and scheduled study visits. A decrease in viral load is a measure used to assess the effectiveness of antiviral treatments.|15 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months.|||Log10 copies per ml||Standard Deviation|Mean
2683580|NCT01374906|Secondary|Actual Change in Mean Urinary Free Cortisol (mUFC) From Baseline|Actual change in mUFC (nmol/24h) from baseline by randomized groups.|baseline, Month 7 (M7), Month 12 (M12), Month 24 (M24) , Month 36 (M36)|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||nmol/24h||Standard Deviation|Mean
2683077|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 18 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 18 months.|||cells per mm³||Standard Deviation|Mean
2683078|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 15 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 15 months.|||cells per mm³||Standard Deviation|Mean
2683079|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 12 months|Only participants receiving lopinavir/ritonavir capsules were planned to be followed past 9 months. Change from baseline analysis is based on participants receiving capsule formulation with CD4 count results available at 12 months.|||cells per mm³||Standard Deviation|Mean
2683080|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 9 months|Change from baseline analysis is based on participants with CD4 count results available at 9 months.|||cells per mm³||Standard Deviation|Mean
2683081|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 6 months|Change from baseline analysis is based on participants with CD4 count results available at 6 months.|||cells per mm³||Standard Deviation|Mean
2683082|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 3 months|Change from baseline analysis is based on participants with CD4 count results available at 3 months.|||cells per mm³||Standard Deviation|Mean
2683083|NCT01379703|Primary|Changes in CD4 Count|Increases in CD4 count are a biomarker for antiretroviral treatment effectiveness in restoring immunologic function. Changes in participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the change from Baseline in the number of CD4+ cells at scheduled study visits.|Baseline to 1 month|Change from baseline analysis is based on participants with CD4 count results available at 1 month.|||cells per mm³||Standard Deviation|Mean
2683084|NCT01379703|Primary|CD4 Count|CD4 lymphocyte count is a measure of a participant's immunologic health. Participants' CD4-positive (CD4+) T-lymphocyte counts were assessed by measuring the number of CD4+ cells at baseline.|Baseline|Mean CD4 count is based on number of participants in each group who had CD4 count results at Baseline.|||cells per mm³||Standard Deviation|Mean
2683085|NCT01379664|Secondary|Total Intraoperative Opioid Consumption|Total amount of opioid in IV morphine equivalents used during surgeyr|intraoperative||||mg||Standard Deviation|Mean
2683086|NCT01379664|Secondary|Time-weighted Average Verbal Rating Pain Score|Time-weighted average VRS (Verbal Rating Scale) pain score over the first 72 h after surgery as recorded by nurses at approximately 4-h intervals. The VRS pain score is from 0 (no pain) to 10 (worst imaginable pain).|up to 72 hours after surgery|Postoperative pain measurements were not available for 19 isoflurane patients and 20 sevoflurane patients.|||units on a scale||Standard Deviation|Mean
2683087|NCT01379664|Primary|Hospital Length of Stay||participants will be followed for the duration of hospital stay, an expected average of 3 days||||Days||Inter-Quartile Range|Median
2683088|NCT01379651|Secondary|Changes in the Median Weal Diameter, Using Egg White SPTs, End-point SPT and PP|Before and after SOTI, we evaluated the change in the median weal diameter in millimeters, using egg white SPTs, end-point SPT and PP.|Baseline and 6 months|We were unable to calculate sample size because no quantitative data about the clinical outcome could be hypothesized. Indeed, the few reports of food causing allergy, the protocol, the way of SOTI administration and food doses administered yielded reported variable results. the analysis was per intention to treat|||mm diameter||Full Range|Median
2683089|NCT01379651|Primary|Number of Children That Achieved Total (40 ml) or Partial (Less Than 40 ml But at Least 10 ml) Tolerance to Raw Egg|To evaluate the efficacy of a 6-month Specific Oral Tolerance Induction (SOTI) protocol in inducing tolerance (maximal dose of raw egg emulsion tolerated after 6 months) in children with severe IgE-mediated egg allergy and a history of at least 1 anaphylactic reaction after accidental exposure to egg.|baseline and 6 months||||participants|||Number
2683090|NCT01379625|Secondary|Exercise Heart Rate|Subjects will complete a submaximal treadmill exercise study at baseline. Exercise heart heart, ventilation and perceived exertion will be measured. Subjects will be randomized to MCT or triheptanoin supplementation for 4 months. At the end of treatment, the exercise test will be repeated keeping work performed constant. Change in exercise heart rate, ventilation and exertion will be compared between groups.|change from baseline to 4 months of treatment||||beats per minute||Standard Deviation|Mean
2683091|NCT01379625|Primary|Ejection Fraction|Change in resting ejection fraction over 4 month treatment period|4 months|Change in resting ejection fraction over 4 month treatment period calculated as: 4 month ejection fraction-baseline ejection fraction. Only participants with available data are included in this analysis.|||percent||Standard Deviation|Mean
2684469|NCT01367847|Primary|Retention|Retention assesses whether or not the family completed the full treatment program.|Baseline to Post-Intervention (average 8 to 12 weeks)|Given that these analyses focus on retention, the analysis sample is the 19 enrolled parent-child dyads (i.e., including the drop-outs)|||Participants|||Count of Participants
2683092|NCT01379625|Primary|Energy Expenditure|Total energy expenditure will be measured by doubly labeled water and resting energy expenditure will be measured by indirect calorimetry at baseline and again after 4 months of either MCT or trihpetanoin treatment.|change from baseline after 4 months of treatment|One subject in each group did not complete the doubly labeled water measures. A total of 15 in each group measured total energy expenditure at baseline and at the end of the study. This value compares the change over treatment.|||kcal/day||Standard Deviation|Mean
2683093|NCT01379573|Secondary|Abnormal Fluid Collection||At birth (approximately 9 months)||||Participants|||Count of Participants
2683094|NCT01379573|Secondary|Birth Weight <10% in the Context of Gestational Age||At birth (approximately 9 months)||||Participants|||Count of Participants
2683095|NCT01379573|Secondary|Prematurity|(gestational age <37 weeks at birth)|At birth (approximately 9 months)||||Participants|||Count of Participants
2683096|NCT01379573|Secondary|Cutaneous Neonatal Lupus||Up to 15 months (at birth - 9 months, and 6 months thereafter)||||Participants|||Count of Participants
2683097|NCT01379573|Secondary|Fetal Death Not Related to Cardiac Dysfunction|"An autopsy with full evaluation of the heart will be encouraged but cannot be mandated. If AV block or evidence of a cardiomyopathy can be proven, then these will provide the basis for final categorization. If not possible, the death will not be considered a recurrence rate but will be reported."|Up to 9 months||||Participants|||Count of Participants
2683098|NCT01379573|Secondary|Echocardiographic Densities Consistent With EFE Confirmed Postnatally|(see title)|After enrollment at 16-18 weeks gestation, then weekly until 26 weeks, biweekly to 34 weeks, at birth (approximately 9 months), and at one year follow up (approximately 21 months from enrollment)||||Participants|||Count of Participants
2683099|NCT01379573|Secondary|Any Sign of Myocardial Injury, Without Change in Cardiac Rate or Rhythm|a) shortening fraction <28% = 2 SD below normal mean or qualitatively reduced systolic function; b) cardio-thoracic ratio >0.33; c) hydropic changes; d) moderate/severe tricuspid regurgitation.|After enrollment at 16-18 weeks gestation, then weekly until 26 weeks, biweekly to 34 weeks, at birth (approximately 9 months), and at one year follow up (approximately 21 months from enrollment)||||Participants|||Count of Participants
2683100|NCT01379573|Secondary|Prolonged PR Interval (>150msec)|EKG at birth must confirm 1st degree AV block. It is also possible that a fetus developing 1st degree block on study medication might have developed more advanced block in the absence of study medication.|After enrollment at 16-18 weeks gestation, then weekly until 26 weeks, biweekly to 34 weeks, at birth (approximately 9 months), and at one year follow up (approximately 21 months from enrollment)||||Participants|||Count of Participants
2683101|NCT01379573|Primary|Recurrence of Advanced Heart Block|Echocardiogram reveals 2nd or 3rd degree AV block|After enrollment at 16-18 weeks gestation, then weekly until 26 weeks, biweekly to 34 weeks, at birth (approximately 9 months), and at one year follow up (approximately 21 months from enrollment)||||Participants|||Count of Participants
2683102|NCT01379534|Secondary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths|Adverse event monitoring was conducted throughout the study.|up to 30 days after the last dose of study drug, up to 18 weeks|Safety analysis set: The safety set included all participants who received at least one dose of study medication.|||Participants|||Number
2683103|NCT01379534|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a participant did not have an event, PFS was censored at the date of last adequate response assessment before the data analysis cut-off date or the start date of new antineoplastic therapy after study drug discontinuation.|up to 18 weeks|Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.|||Months||95% Confidence Interval|Median
2683104|NCT01379534|Secondary|Overall Survival (OS)|OS was defined as the time from date of treatment to the date of death from any cause. If a participant was not known to have died at the date of analysis cut-off, the OS was censored at the last date of contact.|up to 18 weeks|Full Analysis Set (FAS): The FAS included all participants who received at least one dose of study medication.|||Months||95% Confidence Interval|Median
2683105|NCT01379534|Secondary|Duration of Response (DR)|Duration of response was defined for participants with a CR or PR as the time from the date of the first documented response (CR or PR) to the date of the first documented progression or death due to disease. If a participants did not have a progression event, duration of response was censored at the date of the last adequate tumor assessment before the data analysis cut-off date or the antineoplastic therapy start date or the death date.|up to 18 weeks|This outcome measure was not analyzed. The analysis was not required because there were too few responders.||||||
2683106|NCT01379534|Secondary|Disease Control Rate (DCR)|DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD).|Baseline and every 6 weeks until disease progression, up to 18 weeks|Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.|||Percentage of participants|||Number
2683107|NCT01379534|Secondary|Overall Response Rate (ORR)|ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR).|Baseline and every 6 weeks until disease progression, up to 18 weeks|Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.|||Percentage of participants|||Number
2683108|NCT01379534|Primary|Progression Free Survival (PFS) Rate|"The 18-week PFS was defined as the percentage of participants who did not have a progression event at week 18. Participants who progressed, died, had response assessment of unknown (UNK) or discontinued before 18 weeks of observation without progression were counted as failure. Progressive disease was assessed as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1."|up to 18 weeks|Primary endpoint analysis set (PEAS): The PEAS included all participants who received at least one dose of study medication and had measurable disease at baseline as confirmed by a local Investigator.|||Percentage of participants|||Number
2684755|NCT01364584|Secondary|Echocardiographic Measures - Longitudinal Strain|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||% difference in lengths||Standard Deviation|Mean
2683110|NCT01379521|Secondary|Incidences of Cumulative New Nodular Recurrence, Portal Vein Invasion and Extra Hepatic Metastases|Incidences of cumulative new nodular recurrence, portal vein invasion and extra hepatic metastases but incidence of portal vein invasion meant those patients without documented vascular invasion at screening/baseline. The study was terminated early due to slow enrollment of 4 years, higher than anticipated screen failure rate due to a higher than anticipated proportion of patients having advanced liver disease and a change in clinical practice the total of 80 patients was not reached with only 59 patients recruited in total. The study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.|30 months|Full Analysis Set (FAS) comprises all randomized patients. The trial results are inconclusive as the study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.||||||
2683111|NCT01379521|Secondary|Overall Survival (OS)|Overall survival was defined as the time from date of randomization to date of death due to any cause. If death had not occurred at the date of the analysis cut-off then OS was censored at the date of the last contact.|6, 12, 18, 24, 30 months|Full Analysis Set (FAS) comprises all randomized patients. The trial results are inconclusive as the study was underpowered|||months||90% Confidence Interval|Median
2683112|NCT01379521|Secondary|Overall Response Rate (ORR) and Disease Control Rate (DCR) Based on Original RECIST|Overall response rate was defined as the number of patients whose best overall response was either complete response or partial response according to the Complete response: Disappearance of all target lesions or lymph nodes <10 mm in the short axis Partial response: >30% decrease in sum of the longest diameters (SLD) of target lesions Disease control rate was defined as the number of patients with a best overall response of complete response, partial response or stable disease. The study was terminated early due to slow enrollment of 4 years, higher than anticipated screen failure rate due to a higher than anticipated proportion of patients having advanced liver disease and a change in clinical practice the total of 80 patients was not reached with only 59 patients recruited in total. The study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.|6, 12 months, end of study|Full Analysis Set (FAS) comprises all randomized patients. The trial results are inconclusive as the study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.||||||
2683113|NCT01379521|Secondary|Time to Progression Based on Original RECIST|Time to Progression (TTP) defined as the time from the date of randomization to the date of first documented radiological confirmation of disease progression based on original RECIST criteria. Progressive Disease: >20% increase in sum of the longest diameters (SLD) of target lesions with an absolute increase of ≥5 mm; new lesions. The study was terminated early due to slow enrollment of 4 years, higher than anticipated screen failure rate due to a higher than anticipated proportion of patients having advanced liver disease and a change in clinical practice the total of 80 patients was not reached with only 59 patients recruited in total. The study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.|6, 12 months, end of study|Full Analysis Set (FAS) comprises all randomized patients. The trial results are inconclusive as the study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.||||||
2683114|NCT01379521|Secondary|Overall Response Rate (ORR) and Disease Control Rate (DCR) Based on the Modified RECIST|"Overall response rate was defined as the number of patients whose best overall response was either complete response or partial response according to the modified RECIST. Complete response: Disappearance of arterial phase enhance-ment in all target lesions. Partial response: >30% decrease in sum of the longest diameters (SLD) of viable target lesion (arterial phase enhance-ment)Disease control rate was defined as the number of patients with a best overall response of complete response, partial response or stable disease. The study was terminated early due to slow enrollment of 4 years, higher than anticipated screen failure rate due to a higher than anticipated proportion of patients having advanced liver disease and a change in clinical practice the total of 80 patients was not reached with only 59 patients recruited in total. The study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed."|6, 12 months, end of study|Full Analysis Set (FAS) comprises all randomized patients. The trial results are inconclusive as the study was underpowered due to termination therefore data was not collected and the outcome measure was not analyzed.||||||
2683115|NCT01379521|Primary|Time to Progression (TTP) Based on the Modified RECIST Criteria|"Time to Progression (TTP) defined as the time from the date of randomization to the date of first documented radiological confirmation of disease progression based on modified RECIST criteria. Progressive Disease: >20% increase in sum of the longest diameters (SLD) of viable target lesion (arterial phase enhancement)"|3, 6, 12, 18 and 24 months|Full Analysis Set (FAS) comprises all randomized patients.|||months||90% Confidence Interval|Median
2683116|NCT01379508|Secondary|eGFR Change From Baseline in Telbivudine Arm vs Tenofovir Arm Over the Course of the Study|eGFR changes were calculated using the Modification of Diet in Renal Disease (MDRD) formula: GFR = 186 x (sCr)^(-1.154) x (age)^-0.203 with Female: Multiply GFR by 0.742; Black: Multiply GFR by 1.210. sCr is Serum Creatinine in mg/dl (measured at each scheduled visit). Age in years at visit (=[sCr sample collection date -Date of birth]/365.25). Weight in kilograms, as measured at the visit or the closest previous visit Safety population.|Baseline, 24 weeks, 52 weeks, 104 weeks, 156 weeks|Safety population consisted of patients who received at least 1 dose of study drug and had 1 post-baseline safety assessment. Numbers in parentheses represent the number of participants who met the criteria for the measurement in the 2 LDT arms, LDT Overall, 2 TDF arms, TDF Overall, respectively|||mL/min/1.73 m2||Standard Deviation|Mean
2683117|NCT01379508|Secondary|Percentage of Participants Achieving Secondary Efficacy Endpoints at Week 156 (mITT)|To assess the antiviral efficacy, as evaluated by the percentage of patients achieving HBV DNA <300 copies/mL (51 IU/mL) at Week156, ALT normalization, HBsAg loss, development of HBsAg conversion , cumulative tx emergent resistance, HBV DNA <300 copies/mL with HBV DNA <7 log at Baseline|156 weeks|The modified ITT (mITT) population consisted of all patients in ITT population who were eligible and enrolled into the extension.|||percentage of participants||95% Confidence Interval|Number
2683169|NCT01378429|Secondary|Apparent Clearance of the Drug (CL/F)|CL/F liter per hour (L/hour) is the apparent clearance of the drug|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.|||L/hour||Standard Deviation|Mean
2683118|NCT01379508|Secondary|Percentage of Patients Achieving Secondary Efficacy Endpoints (rITT)|To assess the antiviral efficacy, as evaluated by the percentage of patients achieving HBV DNA <300 copies/mL (51 IU/mL), ALT normalization, HBsAg loss, HBsAg conversion, virologic breakthrough (VB) at study visit, cumulative VB by study defined study period, cumulative treatment-emergent resistance|week 24, 52, 104|Roadmap intent-to-treat (rITT) population was analyzed.|||percentage of particiipants||95% Confidence Interval|Number
2683119|NCT01379508|Primary|Percentage of Participants Achieving HBV DNA < 300 Copies/mL (51 IU/mL) at Week 52 (rITT Population) -|"The primary objective of the study is to compare the efficacy of Roadmap-Concept-based telbivudine treatment versus Roadmap-Concept-based tenofovir treatment in HBeAg-negative CHB patients. The rate of HBV DNA < 300 copies/mL (51 IU/mL) at week 52 will be used for the comparison of the efficacy. The hypothesis is that the aggregated rate of HBV DNA < 300 copies/mL (51 IU/mL) at week 52 of Telbivudine (ARM 1) is non-inferior to Tenofovir (ARM 2). For the treating missing as failure analysis, patients who came for their primary endpoint Week 52 visit within the ± 7-day window but not on the exact designated day of the visit were treated as missing data."|week 52|Roadmap intent-to-treat (rITT) population consisted of patients in the ITT population who did not discontinue before Wk 24 and did not receive add-on. The total of the mono and combination arms were analyzed.|||percentage of participants|||Number
2683120|NCT01379222|Primary|Freedom From Aneurysm-related Mortality Rate (ARM) at 5 Years (1826 Days)|"Aneurysm-Related Mortality (ARM) is defined as death from rupture of the abdominal aortic aneurysm or from any procedure intended to treat the Abdominal Aortic Aneurysm (AAA). If a death occurred within 30 days of any procedure intended to treat the AAA, then it is presumed to be aneurysm related unless there is evidence to the contrary. Deaths occurring after 30 days of any procedure intended to treat the AAA that are procedure-related should be aneurysm related.~> All deaths will be adjudicated by a Clinical Events Committee (CEC) to determine device, procedure and/or AAA relatedness."|5 years||||Proportion of Surviving||95% Confidence Interval|Number
2683121|NCT01379183|Secondary|Small Intestine and Colon Volume|A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume||||mL||Standard Error|Mean
2683122|NCT01379183|Secondary|Small Intestine Volume|A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume||||mL||Standard Error|Mean
2683123|NCT01379183|Secondary|Colonic Volume|A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume||||mL||Standard Error|Mean
2683124|NCT01379183|Secondary|Ileal Volume|The Ileal is the terminal portion of the small intestine extending from the jejunum to the cecum. A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume||||mL||Standard Error|Mean
2683125|NCT01379183|Secondary|Jejunal Volume|The jejunum is the section of the small intestine between the duodenum and the ileum. A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. Small bowel volumes were evaluated with 5 mm thick coronal slices using a fat-suppressed true fast imaging with steady state precession sequence while the participant held his or her breath.|Approximately 60 minutes after beginning ingestion of fluid volume||||mL||Standard Error|Mean
2683126|NCT01379183|Primary|Gastric Volume|A Magnetic Resonance (MR) enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. MR images of the abdomen were acquired with a torso phased array coil and a 1.5 tesla magnet MRI. Gastric volumes were assessed with an axial 3D axial gradient echo sequence, which imaged the entire stomach in 13 seconds.|Approximately 60 minutes after beginning ingestion of fluid volume||||mL||Standard Error|Mean
2683127|NCT01378988|Primary|Number of Subjects Who Received Rescue Medication for Sedation and Analgesic|Participants who received rescue medication midazolam for sedation and/or fentanyl for analgesic during study drug Infusion|During the treatment (6 to 24 hours)|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate pharmacokinetic samples to estimate primary parameters.|||participants|||Number
2683128|NCT01378988|Primary|Absolute Time That Subject is in UMSS Range 2-4 During Treatment Period|"The level of sedation will be assessed using the University of Michigan Sedation Scale (UMSS).~Score 0 (awake/alert); Score 1 (sleepy/responds appropriately); Score 2 (somnolent/arouses to light stimuli); Score 3 (deep sleep/arouses to deeper physical stimuli); Score 4 (unarousable).~The UMSS scores obtained just prior the loading dose (LD) and 5 and 10 minutes during LD; 0, 5, 10, 15, 30, and 60 minutes and thereafter every 4 hours of the maintenance infusion; within 5 minutes of obtaining each pharmacokinetic sample; within 5 minutes prior and after any midazolam rescue during dexmedetomidine infusion period."|During the treatment (6 to 24 hours)|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||Hours||Standard Deviation|Mean
2683129|NCT01378988|Primary|Average Total Faces, Legs, Activity, Cry, and Consolability (FLACC) Score|FLACC scale is a 5 category observational measure to assess pediatric pain on face, legs, activity, cry and consolability. Responses in each category are scored between 0 to 2 (0 = normal, relaxed to 2 = upset, rigid), for a maximum total score of 10.|Prior to loading dose and every hour during the maintenance infusion; within 5 minutes after any fentanyl administration during DEX infusion or every 4 hours in case of continuous fentanyl infusion; within 5 minutes prior and after titration of fentanyl|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||units on a scale||Standard Deviation|Mean
2683130|NCT01378988|Primary|Weight-Adjusted Volume of Distribution (Vdw)|Weight-Adjusted Volume of distribution of dexmedetomidine after intravenous administration.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||Litre per Kilogram||Standard Deviation|Mean
2683131|NCT01378988|Primary|Volume of Distribution (Vd)|Volume of distribution of dexmedetomidine after intravenous administration. Volume of distribution measures how much the drug spreads through the body after the dose.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||Litre||Standard Deviation|Mean
2683132|NCT01378988|Primary|Plasma Clearance (CL)|Clearance of dexmedetomidine after intravenous administration. Clearance is the rate at which the drug is removed from the plasma after the dose.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||Litre per Hour||Standard Deviation|Mean
2683133|NCT01378988|Primary|Weight-Adjusted Plasma Clearance (CLw)|Weight-Adjusted Plasma Clearance of dexmedetomidine after intravenous administration.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||Litre per Hours per Kilogram||Standard Deviation|Mean
2683134|NCT01378988|Primary|Time to Reach Maximum Plasma Concentration (Tmax)|Observed time to reach maximum plasma concentration of dexmedetomidine, expressed in hours|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||Hours||Standard Deviation|Mean
2683135|NCT01378988|Primary|Terminal Elimination Half-life (t1/2)|Terminal elimination half-life of dexmedetomidine. Half-life is the time required for plasma concentration of the drug to decrease by 50%.|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||Hours||Standard Deviation|Mean
2683136|NCT01378988|Primary|Steady State Concentration (Css)|Concentration of dexmedetomidine at steady state in plasma|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||picogram per millilitre||Standard Deviation|Mean
2683137|NCT01378988|Primary|Observed Peak Plasma Concentration (Cmax)|Maximum observed concentration of dexmedetomidine in plasma|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||picogram per millilitre||Standard Deviation|Mean
2683138|NCT01378988|Primary|Area Under the Plasma Concentration-time Curve (AUC0-∞)|Area under the plasma concentration-time curve of dexmedetomidine at 0 to Infinity hours|30 minutes prior to loading dose (LD); 5 minutes before finishing LD; 0.5, 1, 2 and 4-6 hours during maintenance infusion (MI); 30 minutes prior (within 24 hours of start of MI) and 10 minutes, 0.5, 1, 2, 4 and 10 hours end of MI|Full Evaluable Population consisted of all subjects who received study drug for at least 5 hours with adequate PK samples to estimate primary parameters.|||picogram*hour per millilitre||Standard Deviation|Mean
2683139|NCT01378975|Secondary|Percentage of Participants With Adverse Events (AE)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.|From signing of informed consent form up to 28 days after the last dose of study drug (approximately up to 4 years)|The safety population included all participants who received at least one dose of study medication.|||percentage of participants|||Number
2683140|NCT01378975|Secondary|Best Overall Response Rate (BORR) Within the Brain and Outside Brain (Not Necessarily Follows the RECIST Criteria - as Assessed by Investigator)|Percentage of participants who were responders (with best overall response (BOR) documented as confirmed complete response [CR] or partial response [PR]) were reported.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.|||percentage of participants||95% Confidence Interval|Number
2683170|NCT01378429|Secondary|Terminal Half Life (t1/2)|Terminal half-life (t1/2) (hour)|Weeks 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.|||Hour||Standard Deviation|Mean
2683171|NCT01378429|Secondary|Time to the Occurrence of Cmax|tmax (hour) (PK Population)|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.|||Hour||Standard Deviation|Mean
2689507|NCT01326845|Secondary|Difference in Severity of Specific Commonly Reported GI Symptoms Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|months 3 and 6|||||||
2683141|NCT01378975|Secondary|Best Overall Response Rate (BORR) Within the Brain and Outside Brain (Assessed by Investigator)|Percentage of participants who were responders with BOR documented as confirmed CR or PR, stable disease (SD), progressive disease (PD). CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study. Here, ‘n’ indicates the number participants who were evaluable for within brain assessment and who had measurable disease outside brain at baseline for outside brain assessment.|||percentage of participants|||Number
2683142|NCT01378975|Secondary|Overall Survival|Overall survival was defined as time between enrollment on Day 1 and date of death, irrespective of the cause of death. Participants for whom no death was captured on the clinical database were censored at the latest date they were known to be alive prior to or on the cutoff date.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.|||months||Full Range|Median
2683143|NCT01378975|Secondary|Time to Development of New Brain Metastases in Responders|Time to development of new lesions within the brain was defined as the interval between the date of first treatment and the earliest date of documentation of new brain lesions. Participants who were known to be free of new lesions were censored on the date of last tumor assessment.|Date of first treatment and the earliest date of documentation of new brain lesions (approximately up to 4 years)|The ITT population included all participants who were enrolled in the study. Here, number of participants analyzed is the participants who were responders.|||months||Full Range|Median
2683144|NCT01378975|Secondary|Progression-Free Survival (PFS) Based on Tumor Assessment Within Brain Only (Assessed by Investigator )|Progression-free survival was defined as the time between enrollment on Day 1 and the date of first radiographically documented progressive disease (within brain), clinical progressive disease, as assessed by the investigator or death whichever occurred first.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.|||months||Full Range|Median
2683145|NCT01378975|Secondary|Progression-Free Survival (PFS) Based on Overall Tumor Response (Assessed by Investigator)|Progression-free survival was defined as the time between enrollment on Day 1 and the date of first radiographically documented progressive disease (within or outside the brain), clinical progressive disease, as assessed by the investigator or death whichever occurred first.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.|||months||Full Range|Median
2683146|NCT01378975|Secondary|Duration of Response (DOR) (Assessed by Investigator and IRC)|Duration of response was defined as the time interval between the date of the earliest qualifying response and the earliest date of PD or death from any cause. For participants who were alive without progression following the qualifying response, DOR were censored on the date of last available tumor assessment on or before the data cutoff date.|Date of the earliest qualifying response until the earliest date of PD or death from any cause (approximately up to 4 years)|The ITT population included all participants who were enrolled in the study. Here, 'n' indicates number of participants who were responders within brain or outside brain assessed by investigator or IRC.|||months||Full Range|Median
2683147|NCT01378975|Secondary|Best Overall Response Rate Outside the Brain (Assessed by IRC)|BORR outside of brain assessed by IRC is defined as percentage of participants who were responders (with BOR documented as confirmed CR or PR). According to RECIST v1.1 criteria modified for brain metastases, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study. Here, number participants analyzed is the total number of participants who had measurable disease outside brain at baseline.|||percentage of participants||95% Confidence Interval|Number
2683148|NCT01378975|Secondary|Best Overall Response Rate (BORR) in the Brain of Participants With Previously Treated Brain Metastases as Assessed by the IRC Using RECIST v1.1|BORR within brain assessed by IRC is defined as percentage of participants who were responders (with BOR documented as confirmed CR or PR). According to RECIST v1.1 criteria modified for brain metastases, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.|||percentage of participants||95% Confidence Interval|Number
2683149|NCT01378975|Secondary|Best Overall Response Rate (BORR) in the Brain of Participants With Previously Treated or Untreated Brain Metastases as Assessed by the IRC Using RECIST v1.1|Percentage of participants who were responders with BOR documented as confirmed CR or PR, stable disease (SD), progressive disease (PD). CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The ITT population included all participants who were enrolled in the study.|||percentage of participants|||Number
2689508|NCT01326845|Secondary|Difference in Severity of Overall GI AEs Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|months 3 and 6.|||||||
2683150|NCT01378975|Primary|Best Overall Response Rate (BORR) Within Brain of Previously Untreated Participants (Assessed by Independent Review Committee [IRC] Using Modified Response Evaluation Criteria in Solid Tumors [RECIST])|BORR assessed by IRC is defined as percentage of participants who were responders [with best overall response (BOR) documented as confirmed complete response (CR) or partial response (PR)]. The RECIST v1.1 criteria modified for independent review of body and brain lesions was based on current radiology practices. The modifications to RECIST v1.1 included allowing target lesions in the brain to be >=5 mm by contrast-enhanced magnetic resonance imaging scan (in traditional RECIST v1.1 this is >=10 mm), allowing up to 5 target lesions in the brain (in traditional RECIST v1.1 only 2 target lesions), and examining the lesions within the brain and outside the brain separately for analytical purposes. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm), PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline up to the disease progression or death from any cause (approximately 4 years)|The intent to treat (ITT) population included all participants who were enrolled in the study.|||percentage of participants||95% Confidence Interval|Number
2683151|NCT01378962|Secondary|Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation by Mutation Type|EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR mutation was determined in liquid biopsies by reverse transcriptase-polymerase chain reaction (RT-PCR /Cobas).|Baseline, At progression of disease (up to 12 Months)|Analysis population included all participants enrolled in the study who received at least 1 dose of treatment and who had samples for EGFR mutation. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.|||percentage of participants|||Number
2683152|NCT01378962|Secondary|Percentage of Participants With Primary and Secondary Resistance|Primary resistance: participants did not reach SD or PR or CR before going to PD. Secondary resistance: participants experienced PD after having reached SD or PR or CR at least once. CR: complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes must decrease to normal (short axis less than 10 mm), with no new lesions. PR: >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. PD: >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline up to disease progression (up to 12 Months)|Analysis population included all participants enrolled in the study who received at least 1 dose of treatment and who had a documented PD response during the study period.|||percentage of participants|||Number
2683153|NCT01378962|Secondary|Percentage of Participants Achieving CR, PR, or SD as Best Overall Response|The Disease Control Rate was defined as the percentage of participants who had CR or PR or SD as Best Overall Response achieved within the time between the first drug administration and documented disease progression or end of study. According to RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. SD was defined as not qualifying for CR, PR, or PD.|Baseline up to disease progression or end of study (up to 12 Months)|ITT population.|||percentage of participants||95% Confidence Interval|Number
2683154|NCT01378962|Primary|Probability of Being Progression Free 12 Months After Baseline|According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|12 months|ITT population.|||probability of being progression-free||Standard Error|Mean
2683155|NCT01378962|Primary|Progression-Free Survival (PFS)|PFS was defined as the time from baseline to the date of first occurrence of disease progression or death. According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier method.|Up to 1 year after enrollment of the last participant (maximum up to 27 months)|ITT population.|||months||90% Confidence Interval|Median
2683156|NCT01378962|Secondary|Percentage of Participants With Objective Response|Objective response was defined as the percentage of participants with CR or PR as best overall response by RECIST v1.1. To be assigned the status of PR or CR, changes in tumor measurements were to be confirmed by repeated assessments no less than 4 weeks after the criteria for response were first met. CR was defined as complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as >=30% decrease under baseline of sum of diameters of all target lesions. The short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. Participants with no tumor assessment after start of study treatment were considered as non-responders. The percentage of participants with response is presented.|Baseline up to disease progression or end of study (up to 12 Months)|ITT population.|||percentage of participants||95% Confidence Interval|Number
2683172|NCT01378429|Secondary|Maximum Observed Concentration|Cmax (ng/mL) (PK Population)|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.|||ng/mL||Standard Deviation|Mean
2683157|NCT01378962|Secondary|Percentage of Participants With a Response by Best Overall Response|Tumor response was assessed according to RECIST v1.1. Complete response (CR): complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes must decrease to normal (short axis less than 10 mm), with no new lesions. Partial response (PR): greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. PD: >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Stable disease (SD): not qualifying for CR, PR, or PD.|Baseline up to disease progression or end of study (up to 12 Months)|ITT population.|||percentage of participants|||Number
2683158|NCT01378962|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to the date of death due to any cause. OS was assessed using Kaplan-Meier method.|Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months)|ITT population.|||months||Standard Error|Mean
2683159|NCT01378962|Secondary|Percentage of Participants Who Died||Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months)|ITT population.|||percentage of participants|||Number
2683160|NCT01378962|Primary|Percentage of Participants With Disease Progression or Death at 12 Months After Baseline|According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|12 months|Intent to treat (ITT) population included all participants enrolled in the study who received at least 1 dose of treatment.|||percentage of participants|||Number
2683161|NCT01378520|Secondary|Change in Level of B-endorphin Immunoreactivity|Change between pre-treatment and post treatment serum levels of beta-endorphin immunoreactivity measured in pmol/L|At the end of resistance load breathing (4.5 hours after receiving the test article)||||pmol/L||Standard Deviation|Mean
2683162|NCT01378520|Primary|Intensity of Breathlessness|"The average of all ratings for the intensity of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with Ketoconazole and 10 ratings during 10 minutes of RLB with inert powder, then ratings for intensity through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 252 ratings for Ketoconazole and for inert powder.~Subject rating of intensity of breathlessness was obtained at 1 minute intervals during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Intensity and at the top by Greatest Intensity."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)||||units on a scale||Standard Deviation|Mean
2683163|NCT01378520|Primary|Unpleasantness of Breathlessness|"The average of all ratings for the unpleasantness of breathlessness at equivalent times for each subject during Resistive Load Breathing (RLB). For example, if 1 subject provided 6 ratings during 6 minutes of RLB with Ketoconazole and 10 ratings during 10 minutes of RLB with inert powder, then ratings for unpleasantness through 6 minutes were used for analysis for that patient. This approach was used for all subjects to yield a total of 252 ratings for Ketoconazole and for inert powder.~Subject rating of intensity of unpleasantness was obtained during RLB on a 100 mm Visual Analog Scale anchored at the bottom by No Unpleasantness and at the top by Greatest Unpleasantness."|At 1 minute intervals during Resistive Load Breathing at Period 1 (Day 3 or 4) and Period 2 (Day 5, 6 or 7)||||units on a scale||Standard Deviation|Mean
2683164|NCT01378429|Secondary|Change From Baseline in Averaged Daily Subject-reported AM and PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment|TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent 1 = mild 2 = moderate 3 = severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement|weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.|||units on a scale||Standard Deviation|Mean
2683165|NCT01378429|Secondary|Percentage of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.|||percentage of devices|Participants||Number
2683166|NCT01378429|Secondary|Number of Devices With Actuation Consistency, Where Actuation Consistency is Defined as a Dose Indicator Count Within ± 20% of the Subject Self-report of Study Medication Administration||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.|||Devices|Participants||Number
2683167|NCT01378429|Secondary|Ratio (Percentage) of the Number of Correct Advances of the Dose Indicator to the Number of Expected Advances Based on Subject Self-report of Study Medication Administration Plus Extra Non-nasal Actuations||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.|||percentage of number of correct advances||Standard Deviation|Mean
2683168|NCT01378429|Secondary|Apparent Volume of Distribution (Vz/F)|Vz/F Liters (L) is the apparent volume of distribution|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.|||L||Standard Deviation|Mean
2685190|NCT01361867|Primary|Step Length Adaptation|The percentage of the step length change caused by the mechanical perturbation that subjects compensate for|within a trial of the experiment (i.e. a few minutes)||||% of step length compensated for||Standard Error|Mean
2683173|NCT01378429|Secondary|AUC(0-24h)|Area under the concentration-time curve from time 0 to 24 hours. Collected at 0, 30 min, 60 min, 90 min, 2 hours (h), 4 h, 8 h, 12 h, 16 h, and 24h after dosing.|Week 6|PK Population: Subjects in the ITT population who completed the study on treatment medication and had assayed serum concentrations of ciclesonide and/or des ciclesonide. Descriptive statistics were presented for serum drug/metabolite concentrations and evaluable pharmacokinetic parameters.|||ng*hr/mL||Standard Deviation|Mean
2683174|NCT01378429|Secondary|Percentage of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.|Local Treatment-Emergent Adverse Events (ITT Population)|weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.|||percentage of participants|||Number
2683175|NCT01378429|Secondary|Number of Subjects Experiencing Nasal AEs, Including Epistaxis, Nasal Ulceration, and Nasal Perforation.|Local Treatment-Emergent Adverse Events (ITT Population)|weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.|||participants|||Number
2683176|NCT01378429|Secondary|Percentage of Subjects Experiencing AEs||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.|||percentage of participants|||Number
2683177|NCT01378429|Secondary|Number of Subjects Experiencing AEs||weeks 0-6|Intent-to-treat (ITT) Population: All randomized subjects who received at least 1 dose of double blind study medication.|||participants|||Number
2683178|NCT01378429|Secondary|Change From Baseline in Urinary Free Cortisol-Uncorrected for Urine Creatinine||weeks 0-6|The PP population consisted of all ITT subjects who had sufficient blood sample collection at Visit 4/BL and Visit 7/End of Week 6 for serum cortisol measurements, completed the study on treatment medication and had no IPDs.|||mcg/g||Standard Error|Least Squares Mean
2683179|NCT01378429|Secondary|Change From Baseline in Urinary Free Cortisol-Corrected for Urine Creatinine||weeks 0-6|The PP population. Subjects with either missing baseline data or post dose data, or both were not included in the analysis|||mcg/g||Standard Error|Least Squares Mean
2683180|NCT01378429|Primary|The Change in Serum Cortisol Area Under the Curve (AUC) From Time 0 to 24 Hours (0-24), Calculated Using a Trapezoidal Rule, From Baseline to the End of the 6 Week Treatment Period|Area under the concentration-time curve from time 0 to 24 hours [AUC(0-24h)]. Timepoints at which data were collected: 0, 2, 4, 8, 12, 16, and 24 at week 0 and 6.|Week 0 and 6|The Per Protocol (PP) population consisted of all ITT subjects who had sufficient blood sample collection at Visit 4/BL and Visit 7/End of Week 6 for serum cortisol measurements, completed the study on treatment medication and had no important protocol deviations (IPDs).|||mcg•hour/dL||Standard Error|Least Squares Mean
2683181|NCT01378416|Primary|AUC (0-∞) - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity|3-hour IV infusion, every 8 hours for three consecutive days. AUC (0-∞) was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).|Day 1, Day 2, day 3||||ng∙hr/mL||Standard Deviation|Mean
2683182|NCT01378416|Primary|Tmax (Time at Which Cmax First Observed)|3-hour IV infusion, every 8 hours for three consecutive days. Tmax was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).|Day 1, Day 2, Day 3||||hours||Standard Deviation|Mean
2683183|NCT01378416|Primary|Cmax (Maximum Plasma Concentration)|3-hour IV infusion, every 8 hours for three consecutive days. Cmax was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).|Day 1, Day 2, Day 3||||ng/mL||Standard Deviation|Mean
2683184|NCT01378416|Primary|Average Total Body Clearance (Calculated From Rate and Concentration)|3-hour IV infusion, every 8 hours for three consecutive days. Average Total Body Clearance was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).|Day 1, Day 2, Day 3||||L/hr/m^2|||Number
2683185|NCT01378416|Secondary|Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)|Summary of All Adverse Events (AEs) by Maximum Grade Occurring in >= 10% Patients|6 weeks||||Participants|||Number
2683186|NCT01378377|Secondary|Phospho Extracellular Signal Regulated Kinase (pERK ) Levels and Phospho Ribosomal Protein S6 (pS6) Levels in in Peripheral Blood Mononuclear Cells (PBMCs)|During the first cycle (either Cycle 1 non-DDI or Cycle 1-DDI) blood samples will be collected for pharmacodynamic marker assessments by flow cytometry such as phospho-ERK and phospho- S6 activities in PBMCs|DDI cohorts: Days 1, 9 and 10 of Cycle 1; Non-DDI cohorts: Days 1, 8 and 9 of Cycle 1|As the trial was terminated early due to toxicities observed with the combination of pimasertib and temsirolimus, it was decided as per plan not to evaluate the biomarker data for this study||||||
2683187|NCT01378377|Secondary|Number of Subjects With Disease Control Rate|Disease control is defined as confirmed complete response (CR), partial response (PR), or stable disease (SD) >=12 weeks), based on tumor assessments as determined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. CR: The disappearance of all lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the sum of the longest diameter at baseline. SD: Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since treatment started.|From the start of the trial treatment until data cut-off date (23 February 2012)|Data was not evaluated for this outcome as the subjects did not met the minimum criteria duration for the evaluation of the outcome measure due to the early termination of the trial||||||
2683188|NCT01378377|Secondary|Volume of Distribution (Vz) of Temsirolimus|The Vz was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. “Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||liter||Full Range|Median
2683273|NCT01377922|Primary|Change From Baseline Quantitative Myasthenia Gravis (QMG) at 14 Days|The QMG is a physician-rated test including 13 assessments, including facial strength, swallowing, grip strength, and duration of time that limbs can be maintained in outstretched positions. Each of the 13 items is scored from 0 (none) to 3 (severe). The total score can range from 0 to 39. Increased QMG total score correlates to worsening symptoms of LEMS.|Assessment at Baseline and Day 14||||QMG Score||Standard Deviation|Mean
2683189|NCT01378377|Secondary|Apparent Volume of Distribution (Vz/F) of Pimasertib|Volume of distribution (Vz) was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. The Vz after oral dose (Vz/F) was influenced by the fraction absorbed. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|"Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. 'N' =subjects evaluable for this outcome measure; Number Analyzed signifies subjects evaluable for this measure for specified categories for each reporting group, respectively."|||liter||Full Range|Median
2683190|NCT01378377|Secondary|Total Body Clearance From Plasma Following Intravenous Administration (CL) of Temsirolimus|The clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. 'N' =subjects evaluable for this outcome measure; “Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||liter/hour||Full Range|Median
2683191|NCT01378377|Secondary|Apparent Clearance From Plasma Following Oral Administration (CL/f) of Pimasertib|Clearance (CL) of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. The CL obtained after oral dose (CL/F) was influenced by the fraction of the dose absorbed (bioavailability). Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. 'N’ =subjects evaluable for this outcome measure;“Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||liter/hour||Full Range|Median
2683192|NCT01378377|Secondary|Apparent Terminal Half-life (t1/2) of Temsirolimus|The t1/2 was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. N=subjects evaluable for this outcome measure; “Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||hour||Full Range|Median
2683193|NCT01378377|Secondary|Apparent Terminal Half-life (t1/2) of Pimasertib|The t1/2 was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. 'N'=subjects evaluable for this outcome measure; “Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||hour||Full Range|Median
2683194|NCT01378377|Secondary|Area Under Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of Temsirolimus|The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. 'N’=subjects evaluable for this outcome measure;“Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||hour*nanogram/milliliter||Full Range|Median
2683195|NCT01378377|Secondary|Area Under the Concentration Time Curve During a Dosing Interval (AUCtau) and Area Under the Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of Pimasertib|The AUCtau was defined as the area under the concentration curve divided by the dosing interval. AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1 for AUCtau; DDI cohorts: Day 1 of Cycle 1 AUC0-inf|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. 'N’=subjects evaluable for this outcome measure; “Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||hour*nanogram/milliliter||Full Range|Median
2683196|NCT01378377|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Temsirolimus|Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. “Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||hour||Full Range|Median
2683197|NCT01378377|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) of Pimasertib|Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. “Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||hour||Full Range|Median
2683198|NCT01378377|Secondary|Maximum Plasma Concentration (Cmax) of Temsirolimus|Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 8|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. “Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||nanogram/milliliter||Full Range|Median
2683199|NCT01378377|Secondary|Maximum Plasma Concentration (Cmax) of Pimasertib|Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan.|Drug-drug interaction (DDI) cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1|Pharmacokinetic analysis was performed in all the subjects who received at least one administration of trial medication and whose plasma samples were collected. “Number Analyzed” signifies subjects evaluable for this measure for specified categories for each reporting group, respectively.|||nanogram/milliliter||Full Range|Median
2683200|NCT01378377|Secondary|Number of Subjects With Treatment-emergent Adverse Events (TEAEs)|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. The TEAEs were those events that occur between first dose of trial treatment and up to 30 days after last dose of the trial treatment that were absent before treatment or that worsened relative to pretreatment state.|From the start of the trial treatment until data cut-off date (23 February 2012)|The safety analysis set included all the subjects who received at least one administration of trial medication.|||subjects|||Number
2683201|NCT01378377|Primary|Number of Subjects With Dose Limiting Toxicities (DLTs)|DLT was defined as any of the following toxicities graded as per National Cancer Institute (NCI) common terminology criteria for adverse events (NCI CTCAE v4.0) encountered within cycle 1 of treatment at any dose level and judged not to be related to the underlying disease or concomitant medications. A treatment emergent adverse event (TEAE) of potential clinical significance such that further dose escalation would expose subjects to unacceptable risk; any Grade >=3 non-hematological toxicity except Grade 3 asymptomatic increases in liver function tests, diarrhea, nausea or vomiting with duration <= 48 hours and alopecia; Grade 4 neutropenia of >5 days duration or febrile neutropenia of >1 day duration; Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia; any treatment interruption >2 weeks due to adverse events; any severe, impairing daily functions or life-threatening, complication or abnormality not defined in NCI-CTCAE that is attributable to the therapy.|Up to 21 Days (within Cycle 1)|The dose escalation analysis set included all the subjects who received at least 80% of the planned doses of each treatment (pimasertib and temsirolimus) in the first cycle of treatment or who experienced DLT during the first cycle of treatment regardless of the received amount of drug.|||subjects|||Number
2683202|NCT01378325|Primary|Number of Physician Interventions Needed to Maintain Maternal Blood Pressure After Spinal Anesthesia Within 20% of Baseline and to Treat Bradycardia During Cesarean Delivery.|"Physician interventions are triggered by hemodynamic changes more than 20% of baseline. The intervention can be one or more of the following:~stopping the phenylephrine infusion~changing the rate of phenylephrine infusion~rescue intravenous bolus of phenylephrine (100 µg) for hypotension~rescue intravenous bolus of atropine (0.4 mg) for bradycardia"|Patients will be followed up throughout the Cesarean delivery (average of 1.5 hours).||||number of interventions||Full Range|Median
2683203|NCT01378299|Secondary|Percent Change in Bone Turnover Markers According the Presence of Diabetes Mellitus|Percent change in bone turnover markers from baseline to 18 months.|Baseline to 18 months|Analysis was by intention to treat with the last value carry forward. Thirty-seven subjects with diabetes mellitus group and 41 without diabetes mellitus have complete dataset available for analysis.|||Percentage Changes||Standard Error|Mean
2683204|NCT01378299|Secondary|Percent Change in Bone Mineral Density According the Presence of Diabetes Mellitus|Percent change in bone mineral density from baseline to 18 months|Baseline to 18 months|Analysis was by intention to treat with the last value carry forward. Thirty-nine subjects with diabetes mellitus group and 45 without diabetes mellitus have complete dataset available for analysis.|||Percent change||Standard Deviation|Mean
2683205|NCT01378299|Secondary|Percent Change in Bone Turnover Markers According to the rs1062033 Polymorphism of the CYP19A1 Gene|Percent change in bone turnover markers|Baseline to 18 months|Analysis was by intention to treat with the last value carry forward. Those who had at least one follow-up from baseline were included in the analysis. The data of 79 subjects with acceptable assay coefficient of variability were available for analysis; 15 subjects in the GG, 37 in the GC and 27 in the CC genotype.|||Percent change||Standard Deviation|Mean
2683206|NCT01378299|Secondary|Percent Change in Bone Turnover Markers According to the rs700518 Polymorphism of the CYP19A1 Gene|Percent change in bone turnover from baseline to 18 months.|Baseline to 18 months|Analysis was by intention to treat with the last value carry forward. Those who had at least one follow-up from baseline were included in the analysis. The data of 79 subjects were analyzed; 15 in the GG, 43 in the GA and 21 in the AA genotype.|||perecent change||Standard Deviation|Mean
2683207|NCT01378299|Secondary|Percent Change in Aromatase Gene Activity From the Buffy Coat According to the 700518 Polymorphism of the CYP19A1 Gene|Percent change in gene expression from baseline to 18 months|Baseline to 6 months|Gene expression studies were successful in 27 samples; 6 in the GG, 17 in the GA and 4 in the AA genotype.|||percent change||Standard Deviation|Mean
2683208|NCT01378299|Secondary|Percent Change in Hematocrit According to re1062033 Polymorphism of the CYP19A1 Gene|Percent change in hematocrit from baseline to 18 months|Baseline to 18 months|Analysis was by intention to treat with the last value carry forward. Those who had at least one follow-up from baseline were included in the analysis. The data of 85 subjects were available for analysis; 15 subjects in the GG, 37 in the GC and 33 subjects in the CC genotype.|||percent change||Standard Deviation|Mean
2683209|NCT01378299|Secondary|Percent Change in Hematocrit According to the Genotype of the 700518 Polymorphism of the CYP19A1gene|Percent change in hematocrit from baseline to 18 months|baseline to 18 months|Analysis was by intention to treat with the last value carry forward. Those who had at least one follow-up from baseline were included in the analysis. The data of 85 subjects were available for analysis; 16 subjects in the GG, 43 in the GC and 26 subjects in the CC genotype.|||Percent change||Standard Deviation|Mean
2683210|NCT01378299|Secondary|Percent Change in Prostate-specific Antigen (PSA) According to the rs1062033 Polymorphism of the CYP19A1 Gene|Percent change in PSA from baseline at 18 months|from baseline to 18 months|More participants came for their 6-month blood test than for other outcomes e.g. BMD. Since our analysis was intention to treat with the last value carry forward, there were more patients with evaluable PSA data at 18 months, as some patients who had PSA but had no BMD testing etc. who dropped out of the study were also included in the analysis.|||precent change||Standard Deviation|Mean
2684756|NCT01364584|Secondary|Echocardiographic Measures - Circumferential Strain|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||% difference in circumferences||Standard Deviation|Mean
2683211|NCT01378299|Secondary|Percent Change in Prostate-specific Antigen (PSA) According to the rs700518 Polymorphism of the CYP19A1 Gene|Percent change in PSA from baseline to 18 months|From baseline to 18 months|More participants came for their 6-month blood test than for other outcomes e.g. BMD. Since our analysis was intention to treat with the last value carry forward, there were more patients with evaluable PSA data at 18 months, as some patients who had PSA but had no BMD testing etc. who dropped out of the study were also included in the analysis.|||percent change||Standard Deviation|Mean
2683212|NCT01378299|Secondary|Percent Change in Bone Mineral Density According to Body Mass Index (BMI)|Percent changes in bone mineral density from baseline|baseline to 18 months|Analysis was by intention to treat with the last value carry forward. Thirty subjects in BMI group 1, 31 in BMI group 2 and 23 subjects in BMI groups 3 have complete dataset available for analysis. There were a total 84 patients who were able to provide data for this outcome at 18 months.|||Percent change||Standard Error|Mean
2683213|NCT01378299|Primary|Percent Change in Bone Mineral Density (BMD) According to the rs1062033 Polymorphism in the CYP19A1 Gene|Percent change in bone mineral density from baseline to 18 months.|baseline to 18 months|Analysis was by intention to treat with the last value carry forward. Those who had at least one follow-up from baseline were included in the analysis . The data of 82 subjects were available for analysis; 14 in the GG, 38 in the GC and 32 in the CC genotype.|||PERCENT CHANGE||Standard Deviation|Mean
2683214|NCT01378299|Primary|Percent Change in Bone Mineral Density (BMD) According to rs700518 Polymorphism in the CYP19A1 Gene|Percent change in bone mineral density from baseline to 18 months|form baseline to 18 months|Analysis was by intention to treat with the last value carry forward. Those who had at least one follow-up from baseline were included in the analysis. The data from 84 subjects were available for analysis; 15 in the GG, 44 in the GA and 25 in the AA genotype.|||percent change||Standard Deviation|Mean
2683215|NCT01378221|Primary|Peri- and Postoperative Time Course of Circulating 1,25-dihydroxyvitamin D in the First Postoperative Month in Cardiac Surgery Patients||change from baseline within 1 month after cardiac surgery||||percentage||Standard Error|Mean
2683216|NCT01378195|Secondary|Perceived Quality of Life|"The Perceived Quality of Life (PQoL instrument) measures quality of life by the evaluation of major categories of fundamental life needs. This measure was developed using a normative sample of older individuals, and has been used in a number of studies investigating the effects of chronic disorders on the perceived quality of life. The scale contains items describing level of satisfaction with needs and resources in various categories. The scale refers to the caregiver. Minimum (worst value) = 0. Maximum score (best value=10. Higher values represent a better outcome."|3 months||||units on a scale||Standard Deviation|Mean
2683217|NCT01378195|Secondary|Revised Memory and Behavior Problems Checklist|"This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this bothered or upset them. A conditional bother score is calculated which is the upset or bother ratings for only the problematic behavior that occurred. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome."|3 months||||units on a scale||Standard Deviation|Mean
2683218|NCT01378195|Primary|Perceived Stress Scale|"The Perceived Stress Scale measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome."|3 months||||units on a scale||Standard Deviation|Mean
2683219|NCT01378117|Secondary|Percent of Blood Glucose Readings Within Target Range Between 70 and 140 mg/dL Among the Three Groups After 24 Hrs of Randomized Treatment|The blood glucose within target range is defined as the levels between 70 mg/dL and 140 mg/dL. BG was measured before each meal and at bedtime (or every 6 h if a patient was not eating) using a point-of-care glucose meter (ACCUCHECK; Roche, Indianapolis, IN). In addition, BG was measured at any time if a patient experienced symptoms of hypoglycemia or if requested by the treating physician. the percentage of the readings are calculated and compared|during hospitalization, up to 10 days||||percentage of blood glucose readings||Standard Deviation|Mean
2683220|NCT01378117|Secondary|Number of Deaths Among the Subjects in Different Groups|Mortality is defined as death occurring during admission among the participants. The number of deaths in each assigned group is calculated.|during hospitalization, up to 10 days||||Participants|||Count of Participants
2683221|NCT01378117|Secondary|Number of Subjects With Acute Renal Failure Among the Three Randomized Groups During Hospitalization|Acute renal failure is defined as a clinical diagnosis of acute renal failure with documented new-onset abnormal renal function (serum creatinine > 2.2 mg/dL or an increment > 0.5 mg/dL from baseline). The total daily dose of insulin and sitagliptin will be adjusted as per serum creatinine concentration. The total daily insulin dose will be reduced to 0.3 unit/kg in patients with creatinine >1.7 mg/dl. The dose of sitagliptin will be reduced to 50 mg/day in patients with creatinine clearance between 30-50 ml/min (approximate serum creatinine levels >1.7 and ≤3.0 mg/dl for men and >1.5 and ≤2.5 mg/dl for women).|during hospitalization, up to 10 days||||Participants|||Count of Participants
2683222|NCT01378117|Secondary|Mean Length of Stay in Days in the Hospital Among Different Groups|The duration of stay in days in the hospital between the three groups is calculated and mean number of days is measured.|during hospitalization, up to 10 days||||days||Standard Deviation|Mean
2683223|NCT01378117|Secondary|Mean Total Daily Dose of Insulin in Units/Day Given During Hospitalization Among the Three Groups|The total insulin includes total glargine insulin (units/day) and total lispro insulin (units/day) given to subjects for maintaining blood glucose levels during hospitalization in different groups. The goal of therapy was to maintain a fasting and premeal glucose concentration between 100 and 140 mg/dL. The doses of insulin were adjusted daily according to protocol. The mean amount is calculated among the different groups and compared.|during hospitalization, up to 10 days||||units/day||Standard Deviation|Mean
2683296|NCT01377467|Other Pre-specified|Percent Change From Baseline in Total Volumetric Bone Mineral Densitiy (Tot.vBMD) at the Distal Radius|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal radius and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.|||Percent change||95% Confidence Interval|Median
2683224|NCT01378117|Secondary|Number of Patients With a Mean Daily BG > 240 mg/dL After the 1st Day of Treatment Among the Treatment Groups|Mean daily blood glucose levels are measured to assess the treatment Failures. For study purpose Treatment failure was defined as having three or more consecutive Blood Glucose (BG) readings > 240 mg/dL or a mean daily BG >240 mg/dL after the 1st day of treatment. Number of patients with a mean daily BG > 240 mg/dL after the 1st day of treatment are recorded and compared among the treatment groups. BG was measured before each meal and at bedtime (or every 6 h if a patient was not eating) using a point-of-care glucose meter.|during hospitalization,up to 10 days||||Participants|||Count of Participants
2683225|NCT01378117|Secondary|Number of Patients With Severe Hypoglycemic Episodes Among the 3 Treatment Groups|severe hypoglycemic episodes are defined as blood glucose levels <40 mg/dl. The number of patients with these events during the 5 days of hospitalization are recorded and compared. BG was measured before each meal and at bedtime (or every 6 h if a patient was not eating) using a point-of-care glucose meter.|during hospitalization,up to 5 days||||Participants|||Count of Participants
2683226|NCT01378117|Secondary|Number of Patients With Hypoglycemic Events Among the Treatment Groups|Hypoglycemia is defined as blood glucose (BG) reading <70 mg/dl. The number of hypoglycemia events during hospitalization are recorded and compared among the different groups. BG was measured before each meal and at bedtime (or every 6 h if a patient was not eating) using a point-of-care glucose meter|during hospitalization,up to 10 days||||Participants|||Count of Participants
2683227|NCT01378117|Primary|Mean Blood Glucose Levels Among the Three Groups at the Time of Hospitalization to 1st Day After Therapy|The primary outcome of the study is to determine differences in glycemic control as measured by mean BG concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with type 2 diabetes mellitus, at the time of admission to the blood glucose levels 24hrs after the therapy|Admission and after 1st day of therapy||||mg/dl||Standard Deviation|Mean
2683228|NCT01378104|Secondary|IL28B Polymorphism Effect on SVR|We additionally investigate the IL28B polymorphism and this result can effect on the SVR depending on dosage of peginterferon alfa-2a.|post treatment 24 weeks|The patients who agreed to check the genotype were analysed.|||percentage of SVR|||Number
2683229|NCT01378104|Primary|Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a|We investigate whether the SVR between 100% and 80% group of peginterferon alfa 2a is not different.|post treatment 24 weeks|We present the result of intention-to-treat analysis.|||participants who achieved SVR|||Number
2683230|NCT01378065|Secondary|Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the12 Month Visit|Colorectal-anal Distress Inventory is measured by the CRADI-8 at 12 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).|Baseline and 12 months|All subjects|||units on a scale||Standard Deviation|Mean
2683231|NCT01378065|Secondary|Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Month Visit|Colorectal-anal Distress Inventory is measured by the CRADI-8 at 6 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).|Baseline and 6 months|All subjects|||units on a scale||Standard Deviation|Mean
2683232|NCT01378065|Secondary|Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 3 Month Visit|Colorectal-anal Distress Inventory is measured by the CRADI-8 at 3 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).|Baseline and 3 months|All subjects|||units on a scale||Standard Deviation|Mean
2683233|NCT01378065|Secondary|Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Week Visit|Colorectal-anal Distress Inventory is measured by the CRADI-8 at 6 weeks. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).|Baseline and 6 weeks|All subjects|||units on a scale||Standard Deviation|Mean
2683234|NCT01378065|Secondary|Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 12 Months|Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at12 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.|Baseline and 12 months|The 25 subjects who completed the PISQ-12 at the twelve month follow up visit.|||units on a scale||Standard Deviation|Mean
2683235|NCT01378065|Secondary|Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Months|Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 6 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.|Baseline and 6 months|The 26 subjects who completed the PISQ-12 at the six month follow up visit.|||units on a scale||Standard Deviation|Mean
2683297|NCT01377467|Other Pre-specified|Percent Change From Baseline in Cortical Thickness (Ct.Th) at the Distal Tibia|Cortical thickness was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mm.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.|||Percent change||95% Confidence Interval|Median
2683236|NCT01378065|Secondary|Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 3 Months|Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 3 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.|Baseline and 3 months|The 25 subjects who completed the PISQ-12 at the three month follow up visit.|||units on a scale||Standard Deviation|Mean
2683237|NCT01378065|Secondary|Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Weeks|Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 6 weeks. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.|Baseline and 6 weeks|The 28 subjects who completed the PISQ-12 at the six week follow up visit.|||units on a scale||Standard Deviation|Mean
2683238|NCT01378065|Secondary|Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 12 Months|Bladder function is measured by UDI-6 Questionnaire at 12 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.|Baseline and 12 months|All subjects.|||units on a scale||Standard Deviation|Mean
2683239|NCT01378065|Secondary|Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Months|Bladder function is measured by UDI-6 Questionnaire at 6 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.|Baseline and 6 months|All subjects.|||units on a scale||Standard Deviation|Mean
2683240|NCT01378065|Secondary|Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 3 Months|Bladder function is measured by UDI-6 Questionnaire at 3 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.|Baseline and 3 months|All subjects.|||units on a scale||Standard Deviation|Mean
2683241|NCT01378065|Secondary|Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Weeks|Bladder function is measured by UDI-6 Questionnaire at 6 weeks. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.|Baseline and 6 weeks|All subjects.|||units on a scale||Standard Deviation|Mean
2683242|NCT01378065|Secondary|Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months.|"The PGI-I Index consists on one question and was collected at 12 months. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response."|12 months|All subjects|||participants|||Number
2683243|NCT01378065|Secondary|Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months.|"The PGI-I Index consists on one question and was collected at 6 months. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response."|6 months|The 29 subjects who completed the PGI-I at the six month follow up visit.|||participants|||Number
2683244|NCT01378065|Secondary|Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months.|"The PGI-I Index consists on one question and was collected at 3 months. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response."|3 months|The 29 subjects who completed the PGI-I at the three month follow up visit.|||participants|||Number
2683245|NCT01378065|Secondary|Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks.|"The PGI-I Index consists on one question and was collected at 6 weeks. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response."|6 weeks|The 29 subjects who completed the PGI-I at the six week follow up visit.|||participants|||Number
2683274|NCT01377636|Primary|BIS Change|The BIS scale ranges from 0 to 100. The individual's baseline BIS was measured continuously and was maintained in an anesthetic steady state with minimum variance prior to isoproterenol. A deviation from the mean in excess of 3 points (2 STD) was defined categorically as a positive response and was counted dichotomously.The difference between Pre-BIS and Post-BIS was calculated.|Within 20 minutes of starting isoproterenol infusion||||units on a scale||95% Confidence Interval|Mean
2683246|NCT01378065|Secondary|Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the12 Month Visit|Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 12 month visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|12 month|The 6 subjects who were treated in the posterior compartment with Restorelle Direct Fix.|||percentage of subjects|||Number
2683247|NCT01378065|Secondary|Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Month Visit|Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 6 month visit Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|6 month|The 5 subjects who were treated in the posterior compartment with Restorelle Direct Fix and have POP-Q measurement recorded at the six month follow-up visit.|||percentage of subjects|||Number
2683248|NCT01378065|Secondary|Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 3 Month Visit|Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 3 month visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|3 month|The six subjects who had posterior compartment vaginal reconstruction surgery.|||percentage of subjects|||Number
2683249|NCT01378065|Secondary|Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Week Visit|Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 6 week visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|6 week|The 6 subjects who were treated in the posterior compartment with Restorelle Direct Fix.|||percentage of subjects|||Number
2683250|NCT01378065|Secondary|Percentage of Participants With Mesh Exposure/Extrusion After Vaginal Reconstruction Surgery at 12 Months.|"Percentage of participants with anterior and posterior compartment mesh exposure/extrusion after vaginal reconstruction with Restorelle Direct Fix at 12 months. Per the protocol, mesh extrusion is defined as passage gradually out of a body structure or tissue. Mesh exposure is defined as  a condition of displaying, revealing, exhibiting or making accessible e.g. vaginal mesh visualized through separated vaginal epithelium."|12 months|All study subjects.|||percentage of subjects|||Number
2683251|NCT01378065|Primary|Palpability of the Restorelle Direct Fix A&P|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|12 months|All subjects|||participants|||Number
2683252|NCT01378065|Primary|Palpability of the Restorelle Direct Fix A&P|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|6 months|All subjects|||participants|||Number
2683253|NCT01378065|Primary|Palpability of the Restorelle Direct Fix A&P|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|3 months|All study subjects|||participants|||Number
2683254|NCT01378065|Primary|Palpability of the Restorelle Direct Fix A&P|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|6 weeks|All subjects|||participants|||Number
2683255|NCT01378065|Secondary|Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 12 Months|Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 12 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|12 months|The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.|||percentage of subjects|||Number
2683256|NCT01378065|Secondary|Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Months|Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 6 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|6 months|The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.|||percentage of subjects|||Number
2683257|NCT01378065|Secondary|Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 3 Months|Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 3 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|3 months|The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.|||percentage of subjects|||Number
2683258|NCT01378065|Secondary|Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Weeks|Surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 6 weeks. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).|6 weeks|The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.|||percentage of subjects|||Number
2683275|NCT01377636|Other Pre-specified|Number of Participants Who Developed Ischemia or ST Segment Changes|The (ST) segment on the EKG was monitored for changes suggestive of demand ischemia. An observable EKG change compared to baseline was defined categorically as a positive response and was counted dichotomously.|Within 20 minutes of starting isoproterenol infusion||||participants|||Number
2686434|NCT01350232|Secondary|Organ Toxicity|To assess organ toxicity related to fludarabine, cytarabine, cyclophosphamide and low-dose total body irradiation in a population with severe sickle cell anemia.|30 days post infusion|||||||
2683259|NCT01378065|Secondary|Rates of de Novo Dyspareunia|"Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 12 months. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always."|12 months|The 11 sexually active subjects without dyspareunia at baseline. At the 12 month follow-up visit, only 11 subjects were sexually active and thus only 11 subjects completed Question 3.5 on the PISQ-12 questionnaire. Therefore, the number of participants analyzed for this outcome was 11 at the 12 month follow-up visit.|||percentage of subjects|||Number
2683260|NCT01378065|Secondary|Rates of de Novo Dyspareunia|"Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at six months. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always."|6 months|The 12 sexually active subjects without dyspareunia at baseline.|||percentage of subjects|||Number
2683261|NCT01378065|Secondary|Rates of de Novo Dyspareunia|"Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 3 months. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always."|3 months|The 12 sexually active subjects without dyspareunia at baseline.|||percentage of subjects|||Number
2683262|NCT01378065|Secondary|Rates of de Novo Dyspareunia|"Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 6 weeks. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always."|6 weeks|The 12 sexually active subjects without dyspareunia at baseline.|||percentage of subjects|||Number
2683263|NCT01378065|Primary|Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P)|Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.|Baseline|All subjects|||participants|||Number
2683264|NCT01377987|Secondary|Pittsburgh Sleep Quality Index|Pittsburgh Sleep Quality Index is a measure of self-reported sleep quality containing 19 questions that make up 7 component scores that are added to provide a total score. Total scores range from 0-21 (units on a scale) with higher scores representing reduced sleep quality. A score of 5 or more is interpreted as reduced sleep quality. The total score is reported.|1 week|All participants who participated in the relevant study arm.|||units on a scale||Standard Deviation|Mean
2683265|NCT01377987|Secondary|Brain Natriuretic Peptide (NT-proBNP)|Brain natriuretic peptide (NT-proBNP) in morning|1 week|All participants who completed the relevant arm|||pg/ml||Standard Deviation|Mean
2683266|NCT01377987|Secondary|Left-atrial Volume|Left-atrial volume index, echocardiography, bi-plane method. Lower values were considered a favorable outcome. We considered values ≤28 mL/m^2 to indicate normal left atrial volume. Values indicating graded left atrial enlargement were described as follows: mild (29-33 mL/m^2), moderate (34-39 mL/m^2), severe (≥40 mL/m^2).|1 week|echocardiography could not be performed on one study due to rescheduling issues|||mL/m^2||Standard Deviation|Mean
2683267|NCT01377987|Secondary|Sympathetic Activity (Urinary Norepinephrine)|Urinary norepinephrine levels overnight|1 week|All participants who completed the relevant study arm|||ug/g-creatinine||Standard Deviation|Mean
2683268|NCT01377987|Secondary|"Ventilatory Chemoreflex Sensitivity, Loop Gain Using Carbon Dioxide Pulses"|"Chemoreflex loop gain was assessed according to Sands SA et al AJRCCM 2017 Jan 15;195(2):237-246. Loop gain is a unitless ratio measure that describes the magnitude of the increase in ventilation that occurs in response to a prior reduction in ventilation (disturbance) and has units of L/min per L/min. A larger value indicates a more sensitive and unstable control system predisposing to oscillatory breathing. Loop gain was measured on the time scale of 1 min (i.e. response to a 1 cycle/min sinusoidal disturbance, referred to as LG1). The procedure involved brief administration of 7% carbon dioxide in air for 0.5 min (pulses); tests were repeated every 3 min for 30 min while measuring ventilation and carbon dioxide levels at the nose with patients awake and supine.~measured using 0.5 min pulses of carbon dioxide."|1 week|All participants who completed the relevant arm. Morning data are reported.|||unitless||Standard Deviation|Mean
2683269|NCT01377987|Primary|The Severity of Sleep Disordered Breathing (Apnea-hypopnea Index, AHI)|The frequency of apneas and hypopneas (apnea-hypopnea index) was assessed. The primary measure was the value for non-REM supine sleep. A higher value indicates more severe sleep apnea. A value above 15 indicates the presence of moderate-to-severe sleep apnea.|1 week|All participants who were randomized and completed the relevant study arm. Data are for non-REM supine sleep.|||events per hour||Standard Deviation|Mean
2683270|NCT01377922|Secondary|Change in CGI-I Score|"The Investigator completed the 7-point CGI I, based on changes in symptoms, behavior, and functional abilities, at the protocol-specified time points compared to the patient's condition at Day 0.~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse"|Baseline and Day 14||||CGI-I score||Standard Deviation|Mean
2683271|NCT01377922|Secondary|Change From Baseline Timed 25 Foot Walking Test (T25FW) at 14 Days|"The T25FW test, a component of the Multiple Sclerosis Functional Composite, was a quantitative mobility and leg function performance test based on a timed 25-foot walk (National Multiple Sclerosis Society). The patient was directed to walk a clearly marked 25-foot course as quickly and safely as possible. Following a rest of at least 5 minutes, the timed 25-foot walk was repeated. Patients could use assistive devices, such as canes, crutches, or walkers.~All data were normalized to the number of feet per minute, so if the patient walked 25 feet in less than a minute, the result was a speed greater than 25 feet/minute.~The measurement for the T25FW test was the average speed, expressed in feet/minute, of the 2 completed walks."|Assessment at Baseline and Day 14||||feet/minute||Standard Deviation|Mean
2683272|NCT01377922|Primary|Change in SGI Score|"Subject Global Impression (SGI) is a measure of changes in subject's perception of change in overall wellbeing.~The patient is asked to use the 7-point scale below to rate their impression of the effects of the study medication during the preceding 3 days on their physical well being.~Terrible~Mostly dissatisfied~Mixed~Partially satisfied~Mostly satisfied~Pleased~Delighted"|Assessment at Baseline and Day 14|FAS|||SGI score||Standard Deviation|Mean
2683276|NCT01377636|Other Pre-specified|Number of Participants With New Arrhythmia During Steady State.|Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation after return to sinus rhythm. If a non-sinus arrhythmia resulted from the infusion, the arrhythmia was defined categorically as a positive response and was counted dichotomously.|Within 20 minutes of start of isoproterenol||||participants|||Number
2683277|NCT01377636|Other Pre-specified|Number of Participants With Amnesia or No Recall During Steady State|Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation. Specific pre-determined test words were spoken to the subject during administration of isoproterenol. After anesthesia, patients were tested for possible recall of those specific words. If no words were recalled, the result was categorically defined as amnesia.|Within one hour of completing anesthesia||||participants|||Number
2683278|NCT01377636|Other Pre-specified|Number of Participants With Change in Blood Pressure|Non-Invasive Blood Pressure (NIBP) is measured routinely as part of an anesthetic. Pre- and Post Blood Pressures where noted. An increase or decrease of 10 percent or more was defined as a significant change in systolic blood pressure.|Within 20 minutes of starting isoproterenol infusion||||participants|||Number
2683279|NCT01377636|Other Pre-specified|Number of Participants With Significant Change in Heart Rate|Heart rate measured by standard EKG monitor during anesthesia. Pre- and Post Heart rates where noted. An increase of 8 percent or more was defined as a significant change in heart rate.|Within 20 minutes of starting isoproterenol infusion||||participants|||Number
2683280|NCT01377636|Secondary|Number of Participants Who Follow Verbal Command to Squeeze Hands|"Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation. Ability to follow verbal commands before and after isoproterenol infusion was assessed by asking subjects to squeeze my hands."|Within 20 minutes of starting isoproterenol infusion||||participants|||Number
2683281|NCT01377636|Secondary|Number of Participants With Spontaneous Musculoskeletal Movement|Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation. Patients under steady state total venous anesthesia (TIVA) with propofol and remifentanil infusions with BIS around 50 normally do not move even in the absence of neuromuscular blockade. Spontaneous movement appearing like restlessness during sleep is unusual. Several patients under anesthesia after isoproterenol appear to wake up and move spontaneously.|Within 20 minutes of starting isoproterenol infusion||||participants|||Number
2683282|NCT01377636|Primary|Number of Participants With an Increase in BIS Readings During Steady State|Increasing doses of isoproterenol (5,10,15,20 mcg/minute) were administered to patients undergoing catheter ablation for atrial fibrillation. BIS levels were measured continuously before and after isoproterenol administration. Number of participants with increase in BIS reading during anesthetic steady state are reported below. The BIS scale ranges from 0 to 100. The individual's baseline BIS was measured continuously and was maintained in an anesthetic steady state with minimum variance prior to isoproterenol. A deviation from the mean in excess of 3 points (2 STD) was defined categorically as a positive response and was counted dichotomously.|During time of Electrophysiology (EP) studies.||||participants|||Number
2683283|NCT01377623|Secondary|Concentration of IL-8||Post-operative Day 1||||pg/ml||Inter-Quartile Range|Median
2683284|NCT01377623|Secondary|Concentration of IL-6||Post-operative Day 1||||pg/ml||Inter-Quartile Range|Median
2683285|NCT01377623|Secondary|Concentration of IL-1a||Post-operative Day 1||||pg/ml||Inter-Quartile Range|Median
2683286|NCT01377623|Secondary|Concentration of TNF-alpha||Post-operative Day 1||||pg/ml||Inter-Quartile Range|Median
2683287|NCT01377623|Primary|Quality of Recovery Score (QoR-40)|The QoR-40 is a 40 item questionnaire in which each question is answered with a score of 1-5. QoR-40 scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).|Post-operative Day 3||||units on a scale||Standard Deviation|Mean
2683288|NCT01377584|Secondary|Continuous Positive Airway Pressure (CPAP) Adherence|Adherence will be measured as the amount of time that the CPAP machine is turned on and maintained at prescribed pressure. The latter number represents the amount of time power is on and the mask is positioned properly on the face. All patients will be using a CPAP machine with remote monitoring capabilities. Adherence reports are automatically uploaded to a secure data center daily. Adherence data can be accessed through the web-based patient compliance management system, EncoreAnywhere.|one week, one month, and 3 months after CPAP initiation||||hours of use||Standard Deviation|Mean
2683289|NCT01377584|Primary|Sleep Quality|The Pittsburgh Sleep Quality Index (PSQI) is a 19 item questionnaire that measures self-reported sleep quality and disturbances over the last 1 month time period. The questionnaire measures 7 components of sleep quality: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A global PSQI score is obtained by summing the 7 component scores (range = 0-21). A PSQI global score > 5 indicates a poor sleeper.|baseline and 3 months after CPAP initiation||||units on a scale||Standard Deviation|Mean
2683290|NCT01377584|Primary|Sleep-related Functional Outcomes|The Functional Outcomes of Sleep Questionnaire-10 is 10-item questionnaire assesses the impact of sleep disorders of excessive sleepiness on multiple activities of everyday living. Scores for five domains of functioning (e.g., activity, vigilance, intimacy and sexual relationships, general productivity, and social outcome) are obtained. Each domain score ranges from 1 to 4 (1 indicating more difficulty). The total score is derived by calculating the mean of the domain scores and multiplying by five. The total score ranges from 5 to 20, with higher scores indicating greater functioning.|baseline and 3 months after CPAP initiation||||units on a scale||Standard Deviation|Mean
2683291|NCT01377584|Primary|Daytime Sleepiness|The Epworth Sleepiness Scale is an 8-item questionnaire that assesses daytime sleepiness.Total scores range from 0 to 24. A score of > 10 indicates excessive daytime sleepiness.|baseline and 3 months after CPAP initiation||||units on a scale||Standard Deviation|Mean
2683292|NCT01377480|Primary|Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction|Blood samples were collected for qualitative polymerase chain reaction (PCR) assay for Trypanosoma cruzi deoxyribonucleic acid (DNA). Successful response was defined as a negative qualitative PCR value at the Day 180 follow up visit.|Day 180|The Full Analysis Population included all randomized subjects who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2683298|NCT01377467|Other Pre-specified|Percent Change From Baseline in Trabecular Volumetric Bone Mineral Densitiy (Tb.vBMD) at the Distal Tibia|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.|||Percent change||95% Confidence Interval|Median
2683299|NCT01377467|Other Pre-specified|Percent Change From Baseline in Cortical Volumetric Bone Mineral Densitiy (Ct.vBMD) at the Distal Tibia|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.|||Percent change||95% Confidence Interval|Median
2683300|NCT01377467|Other Pre-specified|Percent Change From Baseline in Total Volumetric Bone Mineral Densitiy (Tot.vBMD) at the Distal Tibia|Volumetric BMD (vBMD) was measured via HR-pQCT (Xtreme CT) at the distal tibia and was expressed as mg HA/cm3.|Baseline and month 12|Subgroup of patients (n=24) who participated in the HR-pQCT (Xtreme CT) subprotocol.|||Percent change||95% Confidence Interval|Median
2683301|NCT01377467|Other Pre-specified|1,25-(OH)2 Vitamin D3|Blood levels of 1,25-(OH)2 vitamin D3 were measured as ng/L|baseline, months 3, 6, and 12|For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.|||ng/L||95% Confidence Interval|Least Squares Mean
2683302|NCT01377467|Other Pre-specified|25-OH-vitamin D3|Blood levels of 25-OH-vitamin D3 were measured as microgramm/L|baseline, months 3, 6, and 12|For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.|||microgramm/L||95% Confidence Interval|Least Squares Mean
2683303|NCT01377467|Other Pre-specified|Blood Levels of PTH (ng/L) at Baseline and Months 3, 6, and 12|Blood levels of PTH (ng/L) were measured at baseline and at months 3, 6, and 12|baseline and months 3, 6, and 12|For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.|||ng/L||95% Confidence Interval|Least Squares Mean
2683304|NCT01377467|Other Pre-specified|Blood Levels of Phosphate (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12|Blood levels of phosphate (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, 12|baseline, months 0.5, 1, 2, 3, 6, 12|For this endpoints, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.|||mmol/L||95% Confidence Interval|Least Squares Mean
2683305|NCT01377467|Other Pre-specified|Blood Levels of Calcium (mmol/L) at Baseline and Months 0.5, 1, 2, 3, 6, 12|Blood levels of calcium (mmol/L) were measured at baseline and at months 0.5, 1, 2, 3, 6, and 12|baseline, months 0.5, 1, 2, 3, 6, 12|For this endpoints, an available case analysis was performed, thus all randomised patients with valid data at all time points were included.|||mmol/L||95% Confidence Interval|Least Squares Mean
2683306|NCT01377467|Secondary|P1NP at Baseline and Months 3, 6 and 12|Blood concentrations of P1NP were measured in microgram/L|baseline, month 3, month 6, and month 12|For this endpoints, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.|||microgram/L||95% Confidence Interval|Least Squares Mean
2683307|NCT01377467|Secondary|Beta-CTX at Baseline and Months 3, 6 and 12|Blood concentrations of beta-CTX (microgram/L)|baseline, month 3, month 6, and month 12|For this endpoint, an available case analysis was performed, i.e., all randomised patients with valid data at all time points were included.|||microgram/L||95% Confidence Interval|Least Squares Mean
2683308|NCT01377467|Secondary|Percent Change in BMD at the Femoral Neck From Baseline to Month 6|The femoral neck BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite|Baseline and month 6|The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).|||percent change||Standard Deviation|Mean
2683309|NCT01377467|Secondary|Percent Change in BMD at the Total Hip From Baseline to Month 6|The total hip BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite|Baseline and month 6|The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).|||percent change||Standard Deviation|Mean
2683310|NCT01377467|Secondary|Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 6|The total lumbar spine BMD was measured via DXA and was expressed in g/cm2 hydroxylapatite.|Baseline and month 6|The intention-to-treat was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).|||percent change||Standard Deviation|Mean
2683311|NCT01377467|Secondary|Percent Change in BMD at the Femoral Neck From Baseline to Month 12|The total femoral neck BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite|Baseline and month 12|The intention-to-treat (ITT) was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).|||percent change||Standard Deviation|Mean
2683312|NCT01377467|Secondary|Percent Change in BMD at the Total Hip From Baseline to Month 12|The total hip BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite|Baseline and month 12|The intention-to-treat (ITT) population was used for the analysis of this endpoint, i.e. all subjects were included in the analysis that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).|||percent change||Standard Deviation|Mean
2683313|NCT01377467|Primary|Percent Change in BMD at the Total Lumbar Spine From Baseline to Month 12|The total lumbar spine BMD was measured via Dual Energy X-ray Absorptiometry (DXA) and was expressed in g/cm2 hydroxylapatite|Baseline and month 12|The intention-to-treat (ITT) population was used for the primary efficacy analysis, i.e. all subjects were included that have been randomized to the control group or to the denosumab group. Missing values were replaced with a last-value-carried-forward approach (LVCF).|||percent change||Standard Deviation|Mean
2685191|NCT01361854|Primary|Failure Rate of Sleep Study|"failure rate of polysomnography according to the hook-up protocol. Polysomnographies scored as poor or unsatisafctory according to Redline et al. SLEEP 1998 are considered as failed."|1 day||||percentage of participants|||Number
2683314|NCT01377441|Secondary|Quality of Recovery Score (QoR-40).|The secondary outcome parameters will be the quality of recovery score (QoR-40) to measure quality of recovery from surgery, a simple fatigue scale, digits forward and backward, and the global depression schedule. Forty questions in five dimensions will be scored by patients on a five-point Likert scale. Seven point fatigue scales (in- and out-patient) is often used to assess progress of recovery in head trauma patients. Metrics will be administered on at the baseline visit and or on the day of surgery and on postoperative days 1, 2, 4 and 6.|48h|No data displayed because Outcome Measure has zero total participants analyzed.||||||
2683315|NCT01377441|Primary|Concentrations of the Cytokines Tumor Necrosis Factor Alpha (TNF-alpha), Interleukin IL-1Beta (IL-1Beta), IL-2, IL-6, IL-10, and Interferon-gamma (IFN-gamma) as Well as Prostaglandin E2 at Different Time Points.|Concentration of the cytokines TNF-alpha, IL-1Beta, IL-2, IL-6, IL-10, and IFN-gamma as well as prostaglandin E2 at different time points will be our primary outcome. Changes in mediator levels in the IV ibuprofen versus placebo groups will be compared. Plasma samples will be collected before administration of any drug (after placement of IV lines), at the end of the surgery, and on the first postoperative day.|48h|Unfortunately, due to major flooding at our site, due to Hurricane Sandy, all data and samples for this study were lost. Therefore, it was impossible to analyze any data for this study.||||||
2683316|NCT01377402|Secondary|Participants With Cardiac Events During Follow-up.|Cardiovascular Death. Myocardial infarctions (re-MIs) defined according to WHO criteria of 1979.|2-5 years||||Participants|||Number
2683317|NCT01377402|Primary|Total Mortality.|Mortality for any reason|2-5 years|Patients with suspected ACS|||participants|||Number
2683318|NCT01377389|Secondary|Overall Survival|Overall survival of patients treated with intermittent ADT and ipilimumab in months.|From the date of randomization until the date of first documented progression or date of death from any case, whichever came first, assessed up to 70 months.|Only 22 was analyzed, 5 were uncensored.|||months||Full Range|Mean
2683319|NCT01377389|Secondary|The Total Number of Study Drug Related Events Indicated by the Participants|The total number of adverse events which were related to one of the study drugs. Grade 1- Mild, asymptomatic of mild symptoms; clinical or diagnostic observation only; intervention not indicated. Grade 2- Moderate, minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental (daily living activities). Grate 3- Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care of daily life activities.|From the first dose to the last follow-up, up to 60 months||||related events|||Number
2683320|NCT01377389|Secondary|Time to Progression of Disease (PD) Off Androgen Depravation Therapy (ADT), After Treatment With Intermittent ADT Plus Ipilimumab.|The number of months after the last ADT dose until the PSA progression|2 to 45 months||||months||Full Range|Mean
2683321|NCT01377389|Secondary|Time to Testosterone Recovery (> 50ng/mL) in Patients Treated With Intermittent ADT Plus Ipilimumab.|The presence of testosterone was followed in each patient from the start of treatment until the testosterone lab test was found to be at a value greater than 50ng/mL.|1 month up to 7 months.|Out of 27 participants, 24 were evaluable for outcome analysis.|||months||Full Range|Mean
2683322|NCT01377389|Secondary|The Number of Clonal Expansion of Cluster of Differentiation 8 (CD8) T-cells|"CD8 T-cells are known as cytotoxic T-cells or killer T-cells. When the resting CD8 T-cells are activated, the activated CD8 T-cells multiple to fight a specific target so creating a group of specifically activated T-cells. This test measured the minimal number of clonal expansions of CD8 T-cells that always preceded an adverse response to treatment that was due to increased activity in the immune system itself. The minimal number of clonal expansion points to what this increased activity in the immune system might look like."|Each evaluable patient was followed from the time of their first dose until 30 days after their last dose of study drug|9 were evaluable for outcome analysis out of 11 participants|||clonal expansions|||Number
2683323|NCT01377389|Primary|Number of Participants Who Progressed After 7 Months of Being on Treatment|Anti-tumor activity assessed through serial PSA measurements (blood tests) at 7 months on treatment. Progression defined as two consecutive PSA values increasing by at least 20% or more from the lowest PSA value for each patient.|at the end of 7 months on treatment|Out of 27 participants, 24 were evaluable for outcome analysis.|||Participants|||Count of Participants
2683324|NCT01377233|Secondary|Clinical Global Impression Improvement Scale (CGI-I)|The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment is made independent of whether the rater believes the improvement is drug-related or not.|8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)|All patients who were randomized to the double-blind study period, who took at least one dose of drug, and who had at least one valid PANSS assessment were included in the full analysis set (FAS)|||units on a scale||Standard Deviation|Mean
2683325|NCT01377233|Secondary|Clinical Global Impression Severity Scale (CGI-S) Change From Baseline|The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses their clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).|8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)|All patients who were randomized to the double-blind study period, who took at least one dose of drug, and who had at least one valid PANSS assessment were included in the full analysis set (FAS)|||units on a scale||Standard Error|Mean
2683326|NCT01377233|Secondary|Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline|The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).|8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)|All patients who were randomized to the double-blind study period, who took at least one dose of drug, and who had at least one valid PANSS assessment were included in the analysis.|||units on a scale||Standard Error|Mean
2683327|NCT01377233|Primary|Number of Patients With Adverse Events as a Measure of Safety and Tolerability|Number of patients with treatment-emergent adverse events during each of the two study periods plus corresponding safety follow-up period. Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total)|11 weeks for open-label period; 13 weeks for double-blind period|Adverse events for the 46 patients enrolled in the open-label period are reported in the first (open-label) study arm. Adverse events for the 42 patients (out of the 46 enrolled) who were subsequently randomized to the double-blind period are reported across the last four (randomized) study arms.|||participants|||Number
2683328|NCT01377194|Secondary|Change in Sheehan Disability Scale (SDS) Total Score|The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe)|From Baseline to Week 8|Of the 568 patients randomized to receive double-blind treatment, 562 patients received at least 1 dose of treatment and were included in the Safety Population, and 557 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS assessment and were included in the ITT Population.|||units on a scale||Standard Error|Least Squares Mean
2683329|NCT01377194|Primary|Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score - Mixed-effects Model for Repeated Measures (MMRM) Analysis.|The Montgomery-Asberg Depression Rating Scale (MADRS) rates patients on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point scale. A score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The minimum overall score possible was 0 (absence of symptoms), with a maximum overall score of 60 (maximum severity).|From Baseline to Week 8|Of the 568 patients randomized to receive double-blind treatment, 562 patients received at least 1 dose of treatment and were included in the Safety Population, and 557 patients received at least 1 dose of treatment and had at least 1 postbaseline MADRS assessment and were included in the ITT Population.|||Units on a scale||Standard Deviation|Mean
2683330|NCT01377012|Primary|Extension Phase: Percentage of Patients Achieving a American College of Rheumatology Response ACR20, ACR50 and ACR70||up to week 260|The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1||||||
2683331|NCT01377012|Secondary|Extension Phase: Immunogenicity Against Secukinumab||up to week 260|The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1||||||
2683332|NCT01377012|Secondary|Extension Phase: Changes in Baseline of Quality of Life (Qol) Outcomes Measured by Medical Outcome Short Form SF-36 v2|Short Form Health Survey (SF-36) consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed.|Baseline, up to week 260|The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1||||||
2683333|NCT01377012|Secondary|Extension Phase: Proportion of Subjects Achieving ACR/(EULAR) Remission|ACR/EULAR remission is defined as SDAI ≤ 3.3, where SDAI is a measure of disease activity in RA based on 28 tender and swollen joint counts, CRP, Physician and Patient's Global Assessments of Disease|up to week 260|The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1||||||
2683334|NCT01377012|Secondary|Extension Phase: Proportion of Subjects Achieving Low Disease Activity and Good/Moderate European League Against Rheumatism (EULAR) Responses|Low Disease Activity is defined as DAS28 ≤ 3.2. EULAR good response requires an improvement of > 1.2 in the DAS28 score with a present score of ≤3.2; EULAR moderate response is defined as an improvement of >0.6 to ≤1.2 in DAS28 and a present score of ≤5.1; or an improvement of >1.2 and a present score of >3.2.|up to week 260|The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1||||||
2683335|NCT01377012|Secondary|Extension Phase: Change in Baseline of RA Disease Activity as Measured by Disease Activity Score (DAS28)|"The DAS28 score is a measure of RA disease activity calculated using variables such as swollen joint count, the Erythrocyte Sedimentation Rate (ESR) and patient reported assessment of health.~Using this data, the DAS28 calculation provides a number on a scale from 0-10 indicating the current activity of a patient's RA. A DAS28 score above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 score lower than 2.6."|week 260|The outcome measures were not analyzed, as a result of the lack of efficacy found in study AIN457F2309 and as per changes to the planned analysis plan for CAIN457f2302/E1||||||
2683336|NCT01377012|Primary|Core Study: Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20) at Week 24|ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20 response results at week 24 used non-responder imputation.|Week 24|The Full analysis set (FAS) comprised all patients who were randomized and to whom study treatment had been assigned.|||Percentage of Participants|||Number
2683400|NCT01376362|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week Two Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 Weeks||||ETDRS Letters||Standard Deviation|Mean
2686522|NCT01349816|Secondary|Peak Change in IC|Mean inspiratory capacity (IC) of 1 and 2 hours post-dose minus baseline|Day 1|MITT Population|||Liters||95% Confidence Interval|Least Squares Mean
2683337|NCT01377012|Secondary|Core Study Percentage of Patients Achieving Major Clinical Response (Continuous Six-month Period of ACR70 Response During the 1 Year Period) at Week 52|The major clinical response is defined as continuous six-month period of ACR70 response during the 1 year period. ACR70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 70% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR70 response results at week 24 used non-responder imputation.|52 week|The Full analysis set (FAS) comprised all patients who were randomized and to whom study treatment had been assigned. N=The total number of subjects in the treatment groups with evaluation|||Percentage of Participants|||Number
2683338|NCT01377012|Secondary|Core Study: Change From Baseline at Week 24 in Van Der Heijde Total Modified Sharp Score|Separate radiographs of each hand/wrist and each foot were taken at basline and Week 24. The radiographs were assessed using the van der Heijde modified Sharp score. The change in the Van der Heijde modified Sharp score is calculated against the baseline value. The total van der Heide modified Sharp score goes from 0 to 448, the bigger the change, the worse it is for the patient.|Week 24|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed.|||Score on a scale||Standard Error|Mean
2683339|NCT01377012|Secondary|Core Study: Change From Baseline and Week 24 in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)|"The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, are you able to... perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement."|Baseline, Week 24|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||Score on a scale||Standard Error|Least Squares Mean
2683340|NCT01376908|Secondary|Population PK Parameter: Time to Maximum Plasma Concentration (Tmax)||Up to Week 26|Tmax could not be calculated from the model derived parameters because shrinkage was over 20% for V/F and interindividual variability could not be estimated for Ka.||||||
2683341|NCT01376908|Secondary|Population PK Parameter: Maximum Observed Plasma Concentration (Cmax)||Up to Week 26|Cmax could not be calculated from the model derived parameters because shrinkage was over 20% for V/f and interindividual variability could not be estimated for absorption rate constant (Ka).||||||
2683342|NCT01376908|Secondary|Population PK Parameter: Terminal Elimination Half-life (t1/2)|The t1/2 was defined as the time required for plasma concentration of drug to decrease 50 percent (%) in the final stage of elimination. Since t1/2 could not be obtained from non-compartmental analysis because of sparse data, t1/2 was estimated as Log(2)*(V/F)/(CL/F), where V/F & CL/F were the population apparent central Volume & clearance, estimated from population PK model. The reason for pooling subjects receiving Kuvan & subjects with Phe-restricted Diet was to facilitate the estimation of baseline endogenous value of BH4 which can only observed in subjects not receiving treatment. Ignoring this baseline endogenous value would have led biased stimated of the Kuvan PK parameters. This pooling assumes that the addition of Kuvan does not confound the BH4 measurements in these analyses as a consequence the population PK parameters describing the PK of BH4 are the same for the 2 arms and so cannot be presented in terms of per arm/per treatment group based as per the planned analysis.|Weeks 5 to 12|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. ‘N’ (number of subjects analyzed) =subjects evaluable for this outcome measure.|||hours|||Number
2683343|NCT01376908|Secondary|Population PK Parameter: Area Under the Plasma Concentration Curve, Time 0 to Infinity (AUC [0-infinity])|AUC [0-infinity] was estimated by determining total area under the curve of the concentration versus time curve extrapolated to infinity. Since AUC could not be obtained from non-compartmental analysis because of sparse data, AUC = Dose/(CL/F); CL/F was population apparent clearance estimated from the population PK model, & Dose the actual total dose received by the patient on one dosing interval. The reason for pooling subjects receiving Kuvan &subjects with Phe-restricted Diet was to facilitate estimation of baseline endogenous value of BH4 which can only be observed in subjects not receiving treatment. Ignoring this baseline endogenous value would have led to biased estimated of Kuvan PK parameters. This pooling assumes that the the addition of Kuvan does not confound the BH4 measurements in these analyses as a consequence the population PK parameters describing the PK of BH4 were same for the 2 arms and cannot be presented per arm/per treatment group as per planned analysis.|Weeks 5 to 12|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. ‘N’ (number of subjects analyzed) =subjects evaluable for this outcome measure.|||microgram*hour per liter(mcg*hour/liter)||Standard Deviation|Mean
2683364|NCT01376804|Primary|Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Withdrawal Due to AEs|"An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. Pre-existing conditions which worsen during a study were reported as AEs.~A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant."|52 weeks|Safety Population included all enrolled patients who received at least one dose of study medication and had at least one post-baseline assessment of safety.|||Participants|||Number
2686523|NCT01349816|Secondary|At Least 12% Improvement in FEV1|Proportion of subjects achieving >=12% improvement in FEV1 relative to baseline|Day 1|MITT Population|||Participants|||Number
2683344|NCT01376908|Secondary|Population PK Parameter: Apparent Volume of Distribution (V/f)|V/f is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug. The reason for pooling subjects receiving Kuvan and subjects with Phe-restricted Diet was to facilitate the estimation of baseline endogenous value of BH4 which can only be observed in subjects not receiving the treatment. Ignoring this baseline endogenous value would have led to biased stimated of the Kuvan PK parameters. This pooling assumes that the addition of Kuvan does not confound the BH4 measurements in these analyses as a consequence the population PK parameters describing the PK of BH4 are the same for the 2 arms and so cannot be presented in terms of per arm/per treatment group based as per the planned analysis.|Weeks 5 to 12|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. 'N' (number of subjects analyzed) =subjects evaluable for this outcome measure.|||liter||Standard Error|Mean
2683345|NCT01376908|Secondary|Population Pharmacokinetic (PK) Parameter: Apparent Clearance (CL/f)|CL/f is the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways.The reason for pooling subjects receiving Kuvan and subjects with Phe-restricted Diet was to facilitate the estimation of baseline endogenous value of BH4 which can only be observed in subjects not receiving the treatment. Ignoring this baseline endogenous value would have led to biased stimated of the Kuvan PK parameters. This pooling assumes that the addition of Kuvan does not confound the BH4 measurements in these analyses as a consequence the population PK parameters describing the PK of BH4 are the same for the 2 arms and so cannot be presented in terms of per arm/per treatment group based as per the planned analysis.|Weeks 5 to 12|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. 'N' (number of subjects analyzed) =subjects evaluable for this outcome measure.|||liter per hour||Standard Error|Mean
2683346|NCT01376908|Secondary|Number of Samples With Phenylalanine Hydroxylase (PAH) Gene Mutations|The DNA samples received were quantified by using a nanophotometer, and were aliquoted to a concentration of 20 nanogram/microliter DNA and aliquots from each sample were distributed to one 96-well plate. All samples were Sanger sequenced regarding exons 1 to 13 of the PAH gene in forward direction using the DNAs in the 96-well plate. All samples showing variants were Sanger sequenced regarding the concerned exon in reverse direction using DNA from the original tube. All samples showing a homozygous mutation were analyzed by MLPA. All samples showing only 1 mutation were analyzed by MLPA. All samples showing only 1 or no mutation were resequenced completely (exons 1 to 13) in both directions.|Screening (within 42 days prior to Day 1 of the 26-week study period)|Analysis population included subjects who signed pharmacogenetics (PGx) informed consent and whose samples were available for analysis. Out of 109 subjects screened for the study, 77 PGx informed consent forms were signed and 73 samples were analyzed.|||Sample|||Number
2683347|NCT01376908|Secondary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)||Baseline, Weeks 4, 8, 12, 16, 20, and 26|"Intention-to-treat (ITT) population consisted of all the randomized subjects at the start of the study and were analyzed according to the group allocated. n signifies number of evaluable subjects in the specified categories for each reporting group, respectively."|||mmHg||Standard Deviation|Mean
2683348|NCT01376908|Secondary|Dietary Phe Tolerance During Extension Period|Phe tolerance was defined as the amount of dietary Phe ingested (mg/kg/day) while maintaining blood Phe levels within the selected therapeutic target range (defined as >=120 to <360 mcmol/L).|Every 6 months during 3 year extension period or until product is commercially approved|The extension period of this study is ongoing. Data will be provided after completion of extension period i.e first quarter 2017||||||
2683349|NCT01376908|Secondary|Number of Subjects With Hypophenylalanemia|Hypophenylalanemia is defined as the condition of blood Phe levels <120 mcmol/L.|Week 26|Safety population consisted of all subjects who had some safety assessment data available (at least one visit in vital signs, AE or laboratory results) in the Study Period and who received at least one dose of Kuvan in the Study Period, or who were randomized to Phe-restricted diet alone.|||Subjects|||Number
2683350|NCT01376908|Secondary|Growth Parameters Standard Deviation Scores (SDS)|Growth assessment was performed by monitoring body mass index, height (or length), weight, and maximal occipital-frontal head circumference (MOFHC). Supine length was measured up to 2 years of age thereafter standing height was measured unless subject was unable to stand upright, in which case supine length was measured. Respective parameter SDS was calculated as the value of parameter minus reference mean value of parameter divided by standard deviation of the reference population.|Baseline, Weeks 4, 8, 12, 16, 20, and 26|"Intention-to-Treat (ITT) population consisted of all subjects who were randomized at the start of the Study Period and analyzed according to the group allocated. n signifies number of evaluable subjects in the specified categories for each reporting group, respectively."|||SDS||Standard Deviation|Mean
2683351|NCT01376908|Secondary|Neurodevelopmental Status Assessed Using Bayley III Scales of Infant and Toddler Development|Neurodevelopmental assessments was done using the following age-dependent scales: Bayley III for subjects less than (<) 3.5 years of age and WPPSI III for subjects greater than or equal to (>=) 3.5 to <4 years of age, based on following scores: adaptive behavior composite (ABC) score, cognitive composite (CC) score, language composite (LC) score, motor composite (MC) score., and social-emotional composite (SEC) score. Composite scores ranged from 40 (very poor) to 160 (excellent) and are classified as following: >=115: accelerated performance; 85-114: development within normal limits; 70-84: mildly delayed development; less than or equal to (<=) 69: significant delayed development.|Baseline and Week 26|"Intention-to-Treat (ITT) population consisted of all subjects who were randomized at the start of the Study Period and analyzed according to the group allocated. n signifies number of evaluable subjects in the specified categories, for each reporting group, respectively."|||Units on a scale||Standard Deviation|Mean
2683380|NCT01376557|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12||12 weeks|ITT|||mg/dL||Standard Deviation|Mean
2683381|NCT01376557|Secondary|Number of Participants Achieving a HbA1c Value of <7% at Week 12||12 weeks|ITT|||participants|||Number
2683382|NCT01376557|Primary|Change From Baseline in HbA1c to Week 12||12 weeks|ITT|||% change||Standard Deviation|Mean
2685192|NCT01361633|Secondary|Implicit Memory Task|Assesses implicit memory for anxious and neutral words|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up|||||||
2683352|NCT01376908|Secondary|Number of Subjects With Normal Neuromotor Developmental Milestones Assessed Using Denver Developmental Scale (DDS)|"Subjects with normal neuromotor development were assessed by standardized developmental milestones using a parent/guardian report form in the following areas: fine motor, gross motor, language, and personal-social using DDS Test. DDS Test is a widely used to examine the developmental progress of 0-6 years of children. The scale reflects what percentage of a certain age group is able to perform a certain task. Tasks are grouped into 4 categories (social contact, fine motor skill, language, and gross motor skill) and include items such as smiles spontaneously (performed by 90% of three-month-olds), knocks 2 building blocks against each other (90% of 13-month-olds), speaks 3 words other than mom and dad (90% of 21-month-olds), or hops on 1 leg (90% of 5-year-olds). The more items a child fails to perform (passed by 90% of his/her peers), the more likely the child manifests a significant developmental problems."|Baseline, Weeks 12, 26|"Intention-to-Treat (ITT) population consisted of all subjects who were randomized at the start of the Study Period and analyzed according to the group allocated. n signifies number of evaluable subjects in the specified categories, for each reporting group, respectively."|||subjects|||Number
2683353|NCT01376908|Secondary|Number of Subjects With Any TEAEs, AEs Related to Kuvan, Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study treatment and up to 31 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|From the first dose of study drug administration up to 31 days after the last dose of study drug administration|Safety population included all subjects who either received at least one dose of Kuvan in the study period, or were randomized to Phe-restricted diet alone and who had some safety assessment data available.|||subjects|||Number
2683354|NCT01376908|Secondary|Change From Baseline in Dietary Phe Tolerance After 26 Weeks|Phe tolerance was defined as the amount of dietary Phe ingested (mg/kg/day) while maintaining blood Phe levels within the selected therapeutic target range (defined as >=120 to <360 mcmol/L).|Baseline and at Week 26 (last observation carried-forward [LOCF])|Intention-to-treat (ITT) population consisted of all the randomized subjects at the start of the study and were analyzed according to the group allocated. ‘n’ signifies number of subjects evaluable for this measure at given time points for each reporting group respectively.|||mg/kg/day||Standard Error|Mean
2683355|NCT01376908|Secondary|Mean Blood Phe Levels|Mean blood phe levels were defined as the mean of blood phe levels assessed over each 2-week intervals|Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26|Intention-to-treat (ITT) population consisted of all the randomized subjects at the start of the study and were analyzed according to the group allocated. ‘n’ signifies number of subjects evaluable for this measure at given time points for each reporting group respectively.|||micromol per liter (mmol/L)||Standard Deviation|Mean
2683356|NCT01376908|Primary|Dietary Phenylalanine (Phe) Tolerance at Week 26|Phe tolerance was defined as the amount of dietary Phe prescribed (milligram per kilogram per day [mg/kg/day]) while maintaining blood Phe levels within the selected therapeutic target range (defined as greater than or equal to [>=] 120 to less than [<] 360 micromoles per liter [mcmol/L]).|Week 26|Intention-to-treat (ITT) population consisted of all the randomized subjects at the start of the study and were analyzed according to the group allocated.|||mg/kg/day||Standard Error|Mean
2683357|NCT01376804|Secondary|Number of Participants With Known Ganciclovir Resistance (Mutations in Either UL54 or UL97 Genes)|All patients with measurable CMV had both UL54 and UL97 genes sequenced to assess for known CMV resistance to ganciclovir.|52 Weeks|All patients meeting the resistance analysis criteria are included into the resistance analysis.|||Participants|||Number
2683358|NCT01376804|Secondary|Number of Participants With Death||52 Weeks|ITT population included all enrolled patients who had taken at least one dose of study medication.|||Participants|||Number
2683359|NCT01376804|Secondary|Number of Participants With Graft Loss|Graft loss was defined as the institution of chronic dialysis (at least 6 consecutive weeks), transplant nephrectomy, or retransplantation.|52 Weeks|ITT population included all enrolled patients who had taken at least one dose of study medication.|||Participants|||Number
2683360|NCT01376804|Secondary|Number of Participants With Biopsy Proven Rejection|Renal biopsies were performed as medically indicated. Biopsies were assessed histologically using the updated Banff criteria 1997.|52 Weeks|ITT population included all enrolled patients who had taken at least one dose of study medication.|||Participants|||Number
2683361|NCT01376804|Secondary|Number of Participants With Peak Cytomegalovirus (CMV) Viral Load up to Week 52 Post-Transplant|Blood samples were sent to a central lab for the quantitative assessment of CMV viral load (amount of CMV in the blood) by an FDA-approved molecular-based assay. The number of participants in each category is reported in copies/milliliter (CP/mL). CMV DNA is detected in all categories < 150 CP/mL and above.|52 weeks|ITT population included all enrolled patients who had taken at least one dose of study medication.|||Participants|||Number
2683362|NCT01376804|Secondary|Number of Participants With Cytomegalovirus (CMV) Disease in the First 52 Weeks Post-Transplant as Assessed by the Investigator|A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia by each study center as part of the clinical assessment required for diagnosis of CMV infection. CMV disease included CMV syndrome or tissue invasive CMV. CMV syndrome required fever ≥ 38 degrees Celsius, severe malaise, leukopenia on 2 separate measurements, atypical lymphocytosis ≥ 5%, thrombocytopenia, elevation of hepatic transaminases and presence of CMV in blood. Tissue Invasive CMV required evidence of localized CMV infection in a biopsy or other appropriate symptom and relevant symptoms or signs of organ dysfunction.|52 weeks|Intent-to-treat (ITT) population included all enrolled patients who had taken at least one dose of study medication.|||Participants|||Number
2683363|NCT01376804|Secondary|Number of Participants With Cytomegalovirus (CMV) Infection in the First 52 Weeks Post-Transplant as Assessed by the Investigator|A polymerase chain reaction (PCR) based assay or antigenaemia assay was used for the qualitative assessment of CMV viremia (presence of CMV in the blood) by each study center as part of the clinical assessment required for diagnosis of CMV infection.|52 weeks|Intent-to-treat (ITT) population included all enrolled patients who had taken at least one dose of study medication.|||Participants|||Number
2683365|NCT01376700|Post-Hoc|Number of Inhibitors in Previously Untreated Patients (PUPs) and Minimally Treated Patients (MTPs) - (Only 'True' Inhibitors)|"PUPs = no previous FVIII exposure; MTPs ≤4 previous FVIII exposures~'True' positive inhibitor (PI) = any FVIII inhibitor assay result ≥0.6 Bethesda Units (BU)/mL confirmed by central lab on 2 consecutive samples, ie ≥2 PI results (including first PI test, per study protocol) assessed as either:~i. High FVIII inhibitor titer (>5 BU/mL)~ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL). In addition, to be classified as 'true' positive low FVIII inhibitors titer (≥0.6 - ≤5.0 BU/mL), one of following criteria must be met:~a) Lower or absent therapeutic response at infusion of standard replacement doses (clinically relevant) as deemed by clinician in charge.~b) Any lab result of binding FVIII antibodies (IgM, IgA, IgG, IgG1, IgG2, IgG3, or IgG4) must be positive.~Classification based on first positive FVIII inhibitor assessment. Inhibitor test result is:~> 5 BU/mL, categorized as high-titer inhibitor~≥0.6 BU/mL but ≤5 BU/mL, categorized as low-titer"|50 exposure days to ADVATE|Safety Analysis Set|||inhibitors|||Number
2683366|NCT01376700|Post-Hoc|Number of Participants With Factor VIII (FVIII) Inhibitors by Inhibitor Type (Only 'True' Inhibitors)|"'True' positive inhibitor (PI) defined as any FVIII inhibitor assay result ≥0.6 Bethesda Units (BU)/mL confirmed by central lab on 2 consecutive samples, ie ≥2 PI results (including first PI test, in accordance with study protocol) assessed as either:~i. High FVIII inhibitor titer (> 5 BU/mL)~ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL). In addition, to be classified as 'true' positive low FVIII inhibitors titer (≥0.6 - ≤5.0 BU/mL), one of following criteria must be met:~a) Lower or absent therapeutic response at infusion of standard replacement doses (clinically relevant) as deemed by the clinician in charge.~b) Any lab result of binding FVIII antibodies (IgM, IgA, IgG, IgG1, IgG2, IgG3, or IgG4) must be positive.~Classification based on first positive FVIII inhibitor assessment. Inhibitor test result is:~> 5 BU/mL, then categorized as a high-titer inhibitor~≥0.6 BU/mL but ≤5 BU/mL, then categorized as a low-titer."|50 exposure days to ADVATE|Safety Analysis Set|||participants|||Number
2683367|NCT01376700|Secondary|Number of Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs) at Least Possibly Related to ADVATE|Possibly or probably related adverse events|50 exposure days to ADVATE|Safety Analysis Set|||adverse events|||Number
2683368|NCT01376700|Secondary|FVIII-Specific Antibody Isotype for All Participants at Study Entry and Every 10 Exposure Days (EDs)||50 exposure days to ADVATE|Summary statistics of FVIII-Specific Antibody Isotypes were not performed due to the early termination of the study||||||
2683369|NCT01376700|Secondary|Total Factor VIII (FVIII) Consumption by Participant||50 exposure days to ADVATE|Due to the low number of subjects available for evaluation, no statistical tests were performed to assess the total FVIII consumption by participant||||||
2683370|NCT01376700|Secondary|Correlation of Known Risk Factors to Factor VIII (FVIII) Inhibitor Formation||50 exposure days to ADVATE|Due to the low number of subjects available for evaluation, no statistical tests were performed to assess associations between known risk factors to inhibitor formation.||||||
2683371|NCT01376700|Secondary|Number and Type of Surgeries|"Elective surgery is not allowed during period of first 20 exposure days (EDs)~Peripherally inserted central catheter (PICC)"|50 exposure days to ADVATE|Safety Analysis Set|||surgeries|||Number
2683372|NCT01376700|Secondary|Number, Type, and Severity of All Bleeds Experienced When Different Prophylactic Dosing Frequencies Are Used (Once or Twice Per Week and Unknown Frequency)|"Nominal Dosing Frequency:~1 time per week~2 times per week~Unknown dosing frequency (UK)~Bleeding Type (BT):~Skin~Muscle and Soft Tissue~Mucosal~Joint~Other~Multiple~Total~Bleeding severity:~Minor~Moderate~Severe~Total"|50 exposure days to ADVATE|Safety Analysis Set|||Bleeds|Bleeds||Number
2683373|NCT01376700|Secondary|Number of Participants With Low-titer, High-titer, Transient, and All Factor VIII (FVIII) Inhibitors|"High FVIII inhibitor titer (> 5 Bethesda Unit (BU)/mL)~Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL)"|50 exposure days to ADVATE|Safety Analysis Set|||participants|||Number
2683374|NCT01376700|Secondary|Number of Exposure Days of Treatment With Advate Prior to First Positive Factor VIII (FVIII) Confirmed Inhibitor Assessment|"Confirmed inhibitor is defined as any FVIII inhibitor assay result equal or greater than 0.6 BU/mL confirmed by the central laboratory on 2 consecutive samples, i.e. at least 2 positive inhibitor results (including the first positive inhibitor test, in accordance with the study protocol) assessed as either:~i. High FVIII inhibitor titer (> 5 BU/mL) or~ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL)."|50 exposure days to ADVATE|Safety Analysis Set|||days||Inter-Quartile Range|Median
2683375|NCT01376700|Secondary|Number of Participants With Severe Hemophilia A (FVIII ≤ 1%) With Factor VIII (FVIII) Inhibitor Formation Within the First 50 Exposure Days to ADVATE|"Inhibitor testing will be performed in the central laboratory and a non-zero result must be confirmed in the central laboratory as soon as possible, preferably 1 week after inhibitor testing.~Confirmed FVIII inhibitor is defined as any FVIII inhibitor assay result equal or greater than 0.6 Bethesda Units (BU)/mL confirmed by the central laboratory on 2 consecutive samples, i.e. at least 2 positive inhibitor results (including the first positive inhibitor test, in accordance with the study protocol) assessed as either:~i. High FVIII inhibitor titer (> 5 BU/mL) or~ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL)."|50 exposure days to ADVATE|Safety Analysis Set|||participants|||Number
2683376|NCT01376700|Primary|Number of Participants With Severe and Moderately Severe Hemophilia A (FVIII ≤ 2%) With Factor VIII (FVIII) Inhibitor Formation Within the First 50 Exposure Days to ADVATE|"Inhibitor testing will be performed in the central laboratory and a non-zero result must be confirmed in the central laboratory as soon as possible, preferably 1 week after inhibitor testing.~Confirmed FVIII inhibitor is defined as any FVIII inhibitor assay result equal or greater than 0.6 Bethesda Units (BU)/mL confirmed by the central laboratory on 2 consecutive samples, i.e. at least 2 positive inhibitor results (including the first positive inhibitor test, in accordance with the study protocol) assessed as either:~i. High FVIII inhibitor titer (> 5 BU/mL) or~ii. Low FVIII inhibitor titer (≥0.6 - ≤5.0 BU/mL)."|50 exposure days to ADVATE|"Safety Analysis Set~All study participants had severe Hemophilia A, less than 1% Factor VIII levels. (ie there were no moderately severe hemophilia A participants (FVIII levels >1% to ≤ 2%) in this study."|||participants|||Number
2683377|NCT01376557|Secondary|Change From Baseline in Triglycerides at Week 12||12 weeks|ITT|||mg/dL||Standard Deviation|Mean
2683378|NCT01376557|Secondary|Change From Baseline in Systolic Blood Pressure (SPB) at Week 12||12 weeks|ITT|||mm Hg||Standard Deviation|Mean
2683379|NCT01376557|Secondary|Change From Baseline in Body Weight at Week 12||12 weeks|ITT|||kg||Standard Deviation|Mean
2683383|NCT01376388|Secondary|Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points|A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. An abnormal and significant ECG finding includes the presence of a QT interval corrected for heart rate (QTc interval) >500 milliseconds (msec) or an uncorrected QT interval >600 msec, for participants with Bundle Branch Block QTc >530 msec based on an average QTc value of triplicate ECGs. The study investigator determined if the abnormal ECG finding was CS or NCS. The WD visit was conducted for participants who withdrew at any point during the study. The Week 24/WD and Week 52/WD visits were conducted for participants who completed the Week 24 visit or withdrew before Week 24 and completed the Week 52 visit or withdrew before Week 52, respectively. The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|Baseline (Screening visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed at each time point is indicated by n=X in the category title."|||Participants|||Number
2683384|NCT01376388|Secondary|Change From Baseline in Heart Rate|Heart rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the assessment value at the time of interest minus the Baseline value. The WD visit was conducted for participants who withdrew at any point during the study. The Week 24/WD visit was conducted for participants who completed the Week 24 visit or withdrew before Week 24. The Week 52/WD visit was conducted for participants who completed the Week 52 visit or withdrew before Week 52.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed (represented by n=X in the category title). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population."|||Beats per minute||Standard Deviation|Mean
2683385|NCT01376388|Secondary|Change From Baseline in Blood Pressure|Blood pressure measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the assessment value at the time of interest minus the Baseline value. The WD visit was conducted for participants who withdrew at any point during the study. The Week 24/WD visit was conducted for participants who completed the Week 24 visit or withdrew before Week 24. The Week 52/WD visit was conducted for participants who completed the Week 52 visit or withdrew before Week 52.|Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed (represented by n=X in the category title). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the ITT Population."|||Millimeters of Mercury (mmHg)||Standard Deviation|Mean
2683386|NCT01376388|Secondary|Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title."|||Millimoles/Liter (MMOL/L)||Standard Deviation|Mean
2683387|NCT01376388|Secondary|Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measuremnt of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title."|||Micromoles/Liter (µM/L)||Standard Deviation|Mean
2683388|NCT01376388|Secondary|Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title."|||International Units/Liter (IU/L)||Standard Deviation|Mean
2683397|NCT01376362|Secondary|Change in Intraocular Pressure (IOP) in the Study Eye at Week Two Compared to Baseline|Intraocular pressure was recorded using a standard Goldmann applanation tonometer, a device for the measurement of intraocular pressure between 0 to 78 mm Hg.|Baseline and 2 Weeks||||mm Hg||Standard Deviation|Mean
2683389|NCT01376388|Secondary|Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed at each time point is indicated by n=X in the category title."|||Proportion||Standard Deviation|Mean
2683390|NCT01376388|Secondary|Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)|Blood samples were collected for the measurement of hemoglobin, albumin, and total protein at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by n=X in the category title."|||Grams/Liter (G/L)||Standard Deviation|Mean
2683391|NCT01376388|Secondary|Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurment of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by ''n=X'' in the category title.|||10^9 cells/Liter (GI/L)||Standard Deviation|Mean
2683392|NCT01376388|Secondary|Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD|Blood samples were collected for the measurement of the indicated laboratory parameters at following time points: BL (Week -2), Week 12, Week 24, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).|BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD|"ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by ''n=X in the category title."|||Percentage of cells in blood||Standard Deviation|Mean
2683393|NCT01376388|Primary|Number of Participants With AEs Classified by the Indicated Maximum Grade Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities).|52 weeks|ITT Population|||Participants|||Number
2683394|NCT01376388|Primary|Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period|An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold of >=5%) and SAEs.|52 weeks|Intent-to-Treat (ITT) Population: all participants who had received at least one dose of study drug|||Participants|||Number
2683395|NCT01376362|Secondary|Proportion of Participants With a Visual Loss of 15 or More Early Treatment Diabetic Retinopathy Study (ETDRS) Letters in the Study Eye|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 Weeks||||Percentage of Participants|||Number
2683396|NCT01376362|Secondary|Change in Intraocular Pressure (IOP) in the Fellow Eye at Week Two Compared to Baseline|Intraocular pressure was recorded using a standard Goldmann applanation tonometer, a device for the measurement of intraocular pressure between 0 to 78 mm Hg.|Baseline and 2 Weeks||||mm Hg||Standard Deviation|Mean
2683401|NCT01376362|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Study Eye at Week Two Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 2 Weeks||||ETDRS Letters||Standard Deviation|Mean
2683402|NCT01376362|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Fellow Eye at Week One Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 1 Week||||ETDRS Letters||Standard Deviation|Mean
2683403|NCT01376362|Secondary|Change in ETDRS Best-corrected Visual Acuity (BCVA) in the Study Eye at Week One Compared to Baseline|Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.|Baseline and 1 Week||||ETDRS Letters||Standard Deviation|Mean
2683404|NCT01376362|Secondary|Change in Macular Volume in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline|Macular volume was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 2 Weeks||||mm^3||Standard Deviation|Mean
2683405|NCT01376362|Secondary|Change in Macular Volume in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline|Macular volume was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 2 Weeks||||mm^3||Standard Deviation|Mean
2683406|NCT01376362|Secondary|Change in Macular Volume in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline|Macular volume was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 1 Week||||mm^3||Standard Deviation|Mean
2683407|NCT01376362|Secondary|Change in Macular Volume in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline|Macular volume was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 1 Week||||mm^3||Standard Deviation|Mean
2683408|NCT01376362|Secondary|Change in Excess Central Macular Thickening in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline|Central macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 2 Weeks||||µm||Standard Deviation|Mean
2683409|NCT01376362|Secondary|Change in Excess Central Macular Thickening in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week Two Compared to Baseline|Central macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 2 Weeks||||µm||Standard Deviation|Mean
2683410|NCT01376362|Secondary|Change in Excess Central Macular Thickening in the Fellow Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline|Central macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 1 Week||||µm||Standard Deviation|Mean
2683411|NCT01376362|Primary|Change in Excess Central Macular Thickening in the Study Eye, as Measured by Optical Coherence Tomography (OCT), at Week One Compared to Baseline|Central macular thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue.|Baseline and 1 Week||||µm||Standard Deviation|Mean
2683412|NCT01376349|Primary|Alleviation of the Most Bothersome Vaginal Symptom (Vaginal Dryness or Dyspareunia) Over 12 Weeks|"The primary outcome is severity of the most bothersome vaginal symptom: dryness or dyspareunia. The Vaginal Symptom Measure (VSM) was used to evaluate the severity of vaginal dryness and dyspareunia. The VSM uses a 5- point ordinal response scale; 1=none, 2=mild, 3=moderate, 4=severe and 5=very severe to measure the severity associated with vaginal dryness and/or dyspareunia. For each patient, the change in severity was calculated by subtracting the baseline from the week 12 reported score. Therefore, the full range of scores ranges from -4 (greatest decrease in severity) to 4 (greatest increase in severity). A negative score indicates a decrease in severity from baseline, zero indicates no reported affect and positive scores indicate a more severe report at week 12. The primary assessment method will be a comparison of the averages of the changes over time in the severity items for the most bothersome symptom from baseline to 12 weeks (as indicated at baseline)."|At baseline and 12 weeks|All patients that started treatment and completed their week 12 evaluation are included in this analysis.|||change in units on a scale||Full Range|Median
2683413|NCT01376323|Secondary|Number of Participants With HbA1c < 7.0% and < 6.5%|Data has been presented for number of participants with their corresponding percentages with HbA1c <7.0% and <6.5%.|Up to Week 12|PD population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2683445|NCT01376167|Secondary|Number of Participants With Gastrointestinal Disorders|Gastrointestinal tolerability was analyzed by the number of par experiencing gastrointestinal disorders such as abdominal pain, heartburn, diarrhea, constipation, nausea, and vomiting. The number of participants with gastrointestinal disorders for each treatment group has been summarized.|Up to Day 180|Safety Population|||Participants|||Number
2683414|NCT01376323|Secondary|Change From Baseline in Fructosamine at Week 6 and Week 12|Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day -1 visit. Statistics is provided for least square mean. It was assessed on Baseline (Day -1), Day 41 and Week 12.|Baseline (Day -1) and Week 12|PD population. Only those participants available at the specified time points were analyzed.|||Micromoles per liter||Standard Deviation|Mean
2683415|NCT01376323|Secondary|Summary of Homeostatic Model Assessment (HOMA) Index Calculated From Change From Baseline in Fasting Insulin and Fasting Glucose at Week 12|Mean of triplicate measurements at pre-dose time point was considered for the summary. HOMA was calculated by multiplying insulin concentration with glucose concentration divided by 22.5. Change from Baseline for insulin and glucose was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12.|Baseline (Day 1) and up to Week 12|PD population. Only those participants available at the specified time points were analyzed.|||Index||Standard Deviation|Mean
2683416|NCT01376323|Secondary|Change From Baseline in Fasting Insulin at Week 12|Mean of triplicate measurements at pre-dose time point were considered for the summary. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean at Week 12. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12.|Baseline (Day 1) and up to Week 12|PD population. Only those participants available at the specified time points were analyzed.|||Picomoles per liter||Standard Deviation|Mean
2683417|NCT01376323|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 12|Mean of triplicate measurements at pre-dose time point were considered for the summary. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as mean of Day 1 pre-dose visit. Statistics is provided for least square mean at Week 12. It was assessed on Day 1 (pre-dose), 2 (pre-dose), Week 6 (pre-dose) and Week 12.|Baseline (Day 1) and up to Week 12|PD population. Only those participants available at the specified time points were analyzed.|||Millimoles per liter||Standard Deviation|Mean
2683418|NCT01376323|Secondary|GSK256073 AUC and HbA1c at Week 12 Was Evaluated to Establish the Exposure-response Pharmacokinetic/Pharmacodynamic (PK/PD) Relationship|The relationships between drug exposure and HbA1c and relative PD endpoints of interest was planned to be plotted graphically. The data for this outcome measure was not collected.|Up to Week 12|PD population. The data for this outcome measure was not collected.||||||
2683419|NCT01376323|Secondary|Change From Baseline in 12 Hour Non-esterified Fatty Acids (NEFA) and Glucose Weighted Mean Concentration Value at Day 2 and at Week 6|Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as weighted mean value at Day 1 visit. Statistics is provided for least square mean at Week 6. It was assessed on Baseline (Day 1), Day 2 and Week 6.|Baseline (Day 1) and up to Week 6|PD population. Only those participants available at the specified time points were analyzed.|||Millimoles per liter||Standard Deviation|Mean
2683420|NCT01376323|Primary|Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12|Blood samples for analysis of HbA1c were collected at Baseline (Day -1), Day 41, Week 9 and Week 12. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. Baseline was defined as Day -1 visit. Statistics is provided for least square mean at Week 12.|Baseline (Day -1) and up to Week 12|Pharmacodynamic (PD) population comprised of all participants who provide pharmacodynamic data. Only those participants available at the specified time points were analyzed.|||Percentage of Glycosylated Hemoglobin||Standard Deviation|Mean
2683421|NCT01376323|Primary|Number of Participants With Abnormal Urinalysis: Glucose, Protein, Blood and Ketones by Dipstick|Urinalysis parameters included glucose, protein, blood and ketones by dipstick. It was assessed on Baseline (Day -1) and 12. Urine glucose was measured as grams per deciliter (G/dL).|Up to Week 12|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2683422|NCT01376323|Primary|Number of Participants With Hematology Abnormalities of Potential Clinical Importance (PCI)|Hematology parameters included platelet, red blood cell (RBC) count, mean corpuscular volume (MCV), neutrophils, white blood cell (WBC) count (absolute), mean corpuscular hemoglobin (MCH), lymphocytes, reticulocyte count, mean corpuscular hemoglobin concentration (MCHC), monocytes, hemoglobin, eosinophils, hematocrit and basophils. It was assessed on Baseline (pre-dose Day 1) and 12. Data for parameters with high and low of PCI is provided.|Up to Week 12|Safety population|||Participants|||Count of Participants
2683423|NCT01376323|Primary|Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance (PCI)|Clinical chemistry parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, fasting glucose, total carbon dioxide, gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP), total protein, creatine phosphokinase (CPK) and fasting lipid panel including total cholesterol, triglycerides, high density lipoprotein (HDL) cholesterol and low density lipoprotein (LDL) cholesterol. It was assessed on Baseline (pre-dose Day 1), Week 3 and 12. Data for parameters with high and low of PCI is provided.|Up to Week 12|Safety population|||Participants|||Count of Participants
2683424|NCT01376323|Primary|Number of Participants With Abnormal Electrocardiograms (ECGs) Findings|Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QTc intervals. It was assessed at Baseline (pre-dose Day 1), Day 2, Week 3, Week 6 and 12. Participants with normal, abnormal not clinically significant and abnormal clinically significant ECG were presented.|Up to Week 20|Safety population. Only those participants available at the specified time points were analyzed.|||Participants|||Count of Participants
2683425|NCT01376323|Primary|Change From Baseline in Heart Rate|Mean of triplicate measurements at each time point was considered for the summary. Baseline was defined as pre-dose of Day 1 visit. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. It was assessed on Baseline (pre-dose Day 1), Day 1 (12 hours), Day 2, Week 3, 6, 9 and 12.|Baseline (pre-dose Day 1) and up to Week 12|Safety population. Only those participants available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2683426|NCT01376323|Primary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Mean of triplicate measurements at each time point was considered for the summary. Baseline was defined as pre-dose of Day 1 visit. Change from Baseline was calculated by subtracting the Baseline values from the corresponding post-treatment values. It was assessed on Baseline, Day 1 (12 hours), Day 2 (pre-dose and 12 hours), Week 3, 6 (pre-dose and 12 hours), 9 and 12.|Baseline (pre-dose Day 1) and up to Week 12|Safety population. Only those participants available at the specified time points were analyzed.|||Millimeters of mercury||Standard Deviation|Mean
2683427|NCT01376323|Primary|Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Up to Week 12|Safety population was used which was defined as all participants who received at least one dose of study drug.|||Participants|||Count of Participants
2683428|NCT01376310|Primary|Number of Participants With Adverse Events|Number of participants with adverse events as a measure of safety and tolerability|Until 30 days after the last dose of study treatment. Subjects may have continued to receive study treatment until disease progression, death, unacceptable toxicity or until locally commercially available. The maximum duration of exposure was 76 months.|Safety Set|||Participants|||Count of Participants
2683429|NCT01376297|Primary|Percentage of Patients With Adverse Events|This was a safety study where Adverse Events is the primary outcome (defined by the current ICH Guideline for Good Clinical Practice). Patients were randomized according to a 3:1 ratio (netupitant/palonosetron:aprepitant/palonosetron). No formal comparison was planned, the presence of a control in the same patient population helped interpret any unexpected safety finding in the experimental arm.The number of patients was estimated in order to have more than 100 patients treated with the netupitant/palonosetron comination for up to at least six cycles. Based on 100 patients, if a given AE is not observed, an AE incidence of 3% or greater can be excluded with 95% confidence.|Participants will be followed for the duration of the chemotherapy, an expected average duration of up to 24 weeks assuming 6 chemotherapy cycles given every 4 weeks|Safety Population|||percentage of patients with TEAE|||Number
2683430|NCT01376245|Secondary|Mean Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Domain Score at Day 168|CRQ-SAS measures 4 domains (fatigue, emotional function, mastery and dyspnea) of functioning of participants (par.) with COPD: mastery (amount of control the par. feels he/she has over COPD symptoms); fatigue (how tired the par. feels); emotional function (how anxious/depressed the par. feels); and dyspnea (how short of breath the par. feels during physical activities). Each domain is calculated separately and measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Dyspnea domain score is the mean of all non-missing responses for that domain. Only the dyspnea domain was measured as a secondary outcome. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average of the Day 168 values minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), day, day by BL, and day by treatment interactions.|Baseline (BL) and Day 168|ITT Population. Only those participants available at the indicated time point were assessed.|||Scores on a scale||Standard Error|Least Squares Mean
2683431|NCT01376245|Primary|Mean Change From Baseline in Clinic Visit Pre-dose Trough FEV1 at Day 169|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 was defined as the pre-dose and pre-bronchodilator FEV1, which was obtained at each clinic visit. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing at each clinic visit. Change from Baseline was calculated as the average at each clinic visit minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), baseline - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, day, day by baseline and day by treatment interactions.|Baseline to Day 169|Intent-to-Treat (ITT) Population: all randomized par. who received at least one dose of study medication. Number of par. presented represents those with data available at the time point being presented, however, all par. in the ITT population without missing covariate information with at least one post BL measurement are included in the analysis.|||Liters||Standard Error|Least Squares Mean
2683432|NCT01376167|Secondary|Volume of Distribution (Vc/F) of TQ|Apparent population central volume of distribution of TQ|Day 2, Day 8, Day 15, Day 29 and Day 60|Safety Population|||Liters||90% Confidence Interval|Median
2683433|NCT01376167|Secondary|Oral Clearance (CL/F) of TQ|Apparent population oral clearance of TQ|Day 2, Day 8, Day 15, Day 29 and Day 60|Safety Population|||Liters per hour||90% Confidence Interval|Median
2683434|NCT01376167|Secondary|Number of Participants With Action Taken to Treat Recurrence Episode of P Vivax Malaria|Health outcomes were evaluated based on the actions taken by the participants to treat recurrence episode of P vivax malaria. The reported action taken by site is summarized. Where no action by site have been reported at a visit, the number of participants analyzed is given as 0. Only those participants with data available at the specified data points were analyzed.|Up to Day 180|Safety Population|||Participants|||Number
2683435|NCT01376167|Secondary|Time Lost by Participants or Care Givers From Normal Occupation|Health outcomes were evaluated based on total time lost by participants or care givers due to an episode of malaria. The reported time lost due to recurrence episode of P vivax malaria has been summarized by category and by site. Where categories by site have not been reported at a visit, the number of participants analyzed is given as 0. Only those participants with data available at the specified data points were analyzed.|Up to Day 180|Safety Population|||Days|||Number
2683436|NCT01376167|Secondary|Cost Incurred With Purchase of Medications Associated With Recurrence Episode of Malaria|"Health outcomes were evaluated based on the cost of medications purchased. The reported total medication cost for paracetamol associated with recurrence episode of P vivax malaria has been reported by site. Where costs have not been reported at a visit, the number of participants analyzed is given as 0. Medications recorded as Other and medications without costs are excluded from the analysis. Only those participants with data available at the specified data points were analyzed."|Up to Day 180|Safety Population|||USD||Standard Deviation|Mean
2683437|NCT01376167|Secondary|Cost Associated With Recurrence Episode of P Vivax Malaria|Health outcomes were evaluated based on the total costs spent on treatment, transport, medication and tests. The cost was summarized according to the place at which the participant went to for care (drug shop, trial clinic, other clinic, hospital (inpatient/outpatient), traditional healer, other). The reported costs by type and by site has been summarized. Where costs have not been reported at a visit, the number of participants analyzed is given as 0. Only those participants with data available at the specified data points were analyzed.|Up to Day 180|Safety Population|||US Dollars (USD)||Standard Deviation|Mean
2683438|NCT01376167|Secondary|Number of Participants With Clinical Chemistry Laboratory Data Outside the Reference Range|Blood samples were collected for the evaluation of clinical chemistry parameters including Alanine Aminotransferase (ALT), Alkaline Phosphatase (Alk. Phos), Aspartate Aminotransferase (AST), bilirubin, creatine kinase, creatinine, glomerular filtration rate (GFR), indirect bilirubin and urea. The number of participants with clinical chemistry laboratory data outside the extended normal range (F3) was presented. The upper and lower limits for F3 range were defined by multiplying the normal range limits by different factors. High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment. Only those participants with data available at the specified data points were analyzed.|Up to Day 120|Safety Population|||Participants|||Number
2683439|NCT01376167|Secondary|Number of Participants With Hematology Laboratory Data Outside the Reference Range|Blood samples were collected for the evaluation of hematology parameters including eosinophils, leukocytes, lymphocytes, neutrophils, platelets, reticulocytes and methemoglobin. The number of participants with hematology laboratory data outside the extended normal range (F3) was presented. The upper and lower limits for F3 range were defined by multiplying the normal range limits by different factors. High and low indicated that the participants had values flagged as high and low respectively for the particular parameter any time on-treatment. Only those participants with data available at the specified data points were analyzed.|Up to Day 120|Safety Population|||Participants|||Number
2683440|NCT01376167|Secondary|Number of Participants With TEAEs by Maximum Intensity|An AE is defined as any untoward medical occurrence in a participant under clinical investigation, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is defined as AEs with an onset date and time on or after that of the start of first dose of study medication (including CQ). Number of participants with AEs based on severity has been presented.|Up to Day 180|Safety Population|||Participants|||Number
2683441|NCT01376167|Secondary|Number of Participants With TEAEs and Serious TEAEs|An AE is defined as any untoward medical occurrence in a participant under clinical investigation, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/ birth defect, other situations and is associated with possible drug induced liver injury with hyperbilirubinemia. TEAEs is defined as AEs with an onset date and time on or after that of the start of first dose of study medication (including CQ). Number of participants with TEAEs and serious TEAEs have been presented.|Up to Day 180|Safety Population|||Participants|||Number
2683442|NCT01376167|Secondary|Number of Participants With Retinal Changes From Baseline|Ophthalmic assessments were carried out at pre-qualified sites (Manaus) prior to randomization and at Days 29 and 90 and at withdrawal. Assessments were carried out at Day 180 if the Day 90 assessments showed abnormalities. The last assessment performed on the day of randomization or earlier was considered Baseline. Change from Baseline was calculated as the post Baseline assessment minus the Baseline assessment. The number of participants with definite retinal change and questionable (ques) retinal change from Baseline was presented. Only those participants with data available at the specified data points were analyzed.|Baseline and up to Day 180|Ophthalmic Safety Population. Day 180 was not a required follow up assessment, hence, data was not collected for most participants.|||Participants|||Number
2683443|NCT01376167|Secondary|Incidence of Visual Field Abnormalities Based on Best Corrected Visual Acuity Test Scores|Ophthalmic assessments were carried out at pre-qualified sites (Manaus) prior to randomization and at Days 29 and 90 and at withdrawal. Assessments were carried out at Day 180 if the Day 90 assessments showed abnormalities. The last assessment performed on the day of randomization or earlier was considered Baseline. Best corrected visual acuity was assessed individually for each eye. Scores were recorded as a ratio. The values were used to derive a logMAR score for statistical analysis where logMAR=-1x log10 (ratio score). The mean and standard deviation of logMAR score for each treatment group has been summarized. High scores were associated with worse vision, and low scores with better vision. Only those participants with data available at the specified data points were analyzed.|Up to Day 180|Ophthalmic Safety Population. Day 180 was not a required follow up assessment, hence, data was not collected for most participants.|||logMAR scores||Standard Deviation|Mean
2683444|NCT01376167|Secondary|Number of Participants With Keratopathy|Ophthalmic assessments were carried out at pre-qualified sites (Manaus) prior to randomization and at Days 29 and 90 and at withdrawal. Assessments were carried out at Day 180 if the Day 90 assessments showed abnormalities. The last assessment performed on the day of randomization or earlier was considered Baseline. The number of participants displaying keratopathy in each eye was summarized for each visit. The number of participants with new keratopathy at any time post Baseline was also reported. Ophthalmic Safety Population comprised of all participants in the Safety Population who have results from any eye assessments. Only those participants with data available at the specified data points were analyzed.|Up to Day 180|Ophthalmic Safety Population. Day 180 was not a required follow up assessment, hence, data was not collected for most participants.|||Participants|||Number
2686524|NCT01349816|Secondary|Time to Onset of Action|At least 10% improvement in mean FEV1|Day 1|MITT Population|||Participants|||Number
2683446|NCT01376167|Secondary|Change From Baseline in Percent Methemoglobin|Methemoglobin assessment was made with the aid of a non-invasive signal extraction pulse CO-Oximeter handheld machine (Masimo). The change from Baseline in percent methemoglobin by treatment, time and sex has been summarized. The last assessment performed prior to the first dose of study medication (CQ or randomized treatment) was considered as Baseline. Change from Baseline was calculated as the post baseline assessment minus the Baseline assessment for percent methemoglobin. Only those participants with data available at the specified data points were analyzed.|Baseline and up to Day 120|Safety Population|||Percent Methemoglobin||Standard Deviation|Mean
2683447|NCT01376167|Secondary|Number of Participants With Acute Renal Failure|There were no participants with acute renal failure in the study.|Up to Day 180|Safety Population|||Participants|||Number
2683448|NCT01376167|Secondary|Number of Participants Who Received Blood Transfusion|The number of participants who received blood transfusion as a result of hemoglobin decline has been summarized.|Up to Day 180|Safety Population|||Participants|||Number
2683449|NCT01376167|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) Potentially Related to Hemoglobin Decrease|TEAEs are defined as adverse events (AEs) with an onset date and time on or after that of the start of first dose of study medication (including CQ). The number of participants with TEAEs potentially related to hemoglobin decrease has been presented.|Up to Day 180|Safety Population|||Participants|||Number
2683450|NCT01376167|Secondary|Number of Participants With Hemoglobin Decline From Baseline Over First 29 Days|Glucose-6-phosphate dehydrogenase deficiency (G6PD) deficiency is known to be a risk factor for hemolysis in participants treated with 8-aminoquinolines. Blood samples were collected for the evaluation of hemoglobin levels. Hemoglobin decreases of >=30% or >3 grams/deciliter (g/dL) from Baseline; or, an overall drop in hemoglobin below 6.0 g/dL in the first 15 days of the study were considered as protocol defined serious adverse events (SAEs). Number of participants with maximum hemoglobin decline from Baseline over first 29 days of study has been summarized. Safety Population consisted of all randomized participants who received at least one dose of study medication.|Baseline and up to Day 29|Safety Population|||Participants|||Number
2683451|NCT01376167|Secondary|Time to Fever Clearance|Fever clearance time was defined as time from first dose of treatment to the time when body temperature falls to normal within Study Days 1-4 and remains normal for at least 48 hours up to the Day 8 visit. Fever clearance was considered to have been achieved once an initial temperature of more than 37.40 degree Celsius is reduced to a value less than or equal to 37.40 degree Celsius and in the absence of value more than 37.40 degree Celsius in the following 48 hours up to the Day 8 visit. The time taken to achieve fever clearance was analyzed using Kaplan Meier Methodology. The median fever clearance time along with 95% confidence interval has been presented for each treatment group.|Up to Day 180|mITT Population|||Hours||95% Confidence Interval|Median
2683452|NCT01376167|Secondary|Time to Parasite Clearance|Parasite clearance time was defined as time needed to clear asexual parasite from the blood that is, parasite numbers falling below the limit of detection in the thick blood smear and remaining undetectable after 6 to 12 hours. The time taken to achieve parasite clearance was analyzed using Kaplan Meier Methodology. The median parasite clearance time along with 95% confidence interval has been presented for each treatment group.|Up to Day 180|mITT Population|||Hours||95% Confidence Interval|Median
2683453|NCT01376167|Secondary|Time to Recurrence of P Vivax Malaria|Recurrence was defined as the first confirmed presence of P vivax asexual stage parasites after clearance of initial parasitemia following CQ treatment. Time to recurrence was defined as the time (in days) from initial parasite clearance to recurrence. The time to recurrence was analyzed by the Kaplan-Meier method. NA indicates data was not available due to insufficient number of participants with events during the follow up period in the study. The median number of days to recurrence along with 95% confidence interval has been presented for each treatment group.|Up to Day 180|mITT Population|||Days||95% Confidence Interval|Median
2683454|NCT01376167|Secondary|Number of Participants With Recurrence-free Efficacy at 4 Months Post Dose|A participant (par) was considered to have demonstrated recurrence-free efficacy at 4 months if: a) Par had non-zero P vivax asexual parasite count at Baseline. b) Par showed initial clearance of P vivax parasitemia. c) Par had no positive asexual P vivax parasite count at any assessment prior to or on Study Day 130 following initial parasite clearance. d) Par did not take a concomitant medication with anti-malarial activity at any point between Study Day 1 and their last parasite assessment after Study Day 109 (up to and including Study Day 130). e) Par is parasite-free at 4 months defined as a negative asexual P vivax parasite count at the first parasite assessment performed after Study Day 109 (up to and including Study Day 130). Par were censored if they did not have P.vivax at Baseline, or took a drug with anti-malarial action despite not having malaria parasites or did not have a 4 month assessment. The number of par with recurrence-free efficacy at 4 months has been summarized.|4 months post dose|mITT Population|||Participants|||Number
2683455|NCT01376167|Primary|Number of Participants With Recurrence-free Efficacy at 6 Months Post Dose|A participant was considered to have demonstrated recurrence-free efficacy at 6 months if: a) Participant had non-zero P vivax asexual parasite count at Baseline. b) Participant showed initial clearance of P vivax parasitemia defined as two negative asexual P vivax parasite counts, with at least 6 hours between the counts, and no positive counts in the interval. c) Participant had no positive asexual P vivax parasite count at any assessment prior to or on Study Day 201 following initial parasite clearance. d) Participant did not take a concomitant medication with anti-malarial activity at any point between Study Day 1 and their last parasite assessment. e) Participant is parasite-free at 6 months. Participants were censored if they did not have P.vivax at Baseline, or took a drug with anti-malarial action despite not having malaria parasites, or did not have a 6 month assessment. The number of participants with recurrence-free efficacy at 6 months has been summarized.|6 months post dose|Microbiologic intent to treat (mITT) Population-all randomized participants who received at least one dose of study medication, who have at least one P vivax parasite assessment after randomization, and who have a positive parasite smear for P vivax at Baseline.|||Participants|||Number
2683456|NCT01376089|Secondary|Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.|Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration.|Ten minutes post contrast administration.||||Number of subject images|||Number
2683457|NCT01376089|Primary|Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.|Number of subjects experiencing moderate (score of 4 -7) to severe (score of 8 - 10) discomfort for cold, heat or pain between Iodixanol and Iopamidol.|Within 10 minutes post contrast administration.||||Number of Subjects with discomfort|||Number
2683458|NCT01376089|Primary|Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.|Number of subjects experiencing any moderate (score of 4 - 7) to severe (score 8 - 10) discomfort for cold or heat or pain between Iodixanol and Iopamidol.|Within 10 minutes post contrast administration||||Number of Subjects with discomfort|||Number
2683459|NCT01376050|Secondary|Change in Ulcer Size|The study ulcer was digitally photographed, and the ulcer size/area calculated in centimeters squared (cm²) using the Aranz Medical SilhouetteMobile™ System, a portable handheld computer device with custom camera and software that enables capturing of a wound image at the point of care. The change in ulcer size from baseline to study endpoint (12 weeks) was calculated. A decrease in ulcer size indicates an improvement in the ulcer status and is positive for study success. An increase in ulcer size indicates a worsening of the ulcer status and is negative for study success.|Baseline and 12 Weeks||||cm²||Standard Deviation|Mean
2683460|NCT01376050|Primary|Difference in the Proportion of Venous Stasis Ulcers Attaining Complete Wound Closure Between Treatment Groups|'Complete wound closure' is defined as skin re-epithelialization without drainage or dressing requirements confirmed across a consecutive two-week evaluation period. Efficacy success was defined as a statistically significant greater proportion of venous stasis ulcers in the test procedure group achieving complete wound closure compared with the proportion of venous stasis ulcers in the placebo procedure group achieving complete wound closure.|Baseline and 12 Weeks||||participants|||Number
2683461|NCT01376037|Primary|Change in Combined Upper Arm Circumference Measurements From Baseline to Endpoint|Change in combined upper arm circumference measurements is calculated as the difference in combined upper arm circumference measurements from baseline to endpoint (2 weeks) for each of the right upper arm and the left upper arm, separately. A change of at least +1.25 centimeters, for each of the right upper arm and the left upper arm, separately, is considered positive for study success for an individual subject. It was pre-determined that the overall study would be considered a success if at least 50% (16 or more out of 31) of the test group subjects attained individual subject success and individual subject successes in the placebo group were at least 35% lower than for test group subjects (5 or less out of 31).|baseline and 2 weeks||||participants|||Number
2683462|NCT01375946|Secondary|Patch Adhesion|"Patch adhesion scores by investigator evaluation by external condition; including dry sauna, whirlpool, treadmill exercise, normal, and cold water conditions; using the following scale:~0: >90% adhered (essentially no lift off of the skin)~>75% adhered but <90% (some edges showing lift)~>50% adhered but <75% (half of system lifts off)~<50% (> half of system lifts off, but undetached)~patch completely detached~Patches were assessed prior to patch removal."|6 weeks|Safety population|||Score||Standard Deviation|Mean
2683463|NCT01375946|Primary|Css (48-168) Profile of EE|Css (48-168) profile of EE for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.|6 weeks|Primary PK population|||pg/mL||Standard Deviation|Mean
2683464|NCT01375946|Primary|Steady-state Concentration (Css) (48-168) Profile of LNG|Css (48-168) profile of LNG for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.|6 weeks|Primary PK population|||pg/mL||Standard Deviation|Mean
2683465|NCT01375946|Primary|AUC(0-168) Profile of Ethinyl Estradiol (EE)|AUC(0-168) profile of EE for external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.|6 weeks|Primary PK population|||ng*hr/mL||Standard Deviation|Mean
2683466|NCT01375946|Primary|Area Under the Concentration Versus Time Curve (AUC) (0-168) Profile of Levonorgestrel (LNG)|AUC(0-168) profile of LNG for each external condition including dry sauna, normal, whirlpool, cold water, and treadmill exercise. The blood sampling for the pharmacokinetic evaluations was performed at the following time points: 0 hour (immediately prior to dosing) and at 6 hours, 12 hours, 24 hours (1 day), 48 hours (2 days), 72 hours (3 days), 120 hours (5 days), 144 hours (6 days), and 168 hours (7 days) following application of the patch.|6 weeks|Primary PK population|||ng*hr/mL||Standard Deviation|Mean
2683467|NCT01375777|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2683468|NCT01375777|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2683469|NCT01375777|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2683470|NCT01375777|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12||Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2683471|NCT01375777|Secondary|Change From Baseline in LDL-C at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using LOCF.|||mg/dL||Standard Error|Least Squares Mean
2685193|NCT01361633|Secondary|Stroop|Assesses executive functioning|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up|||||||
2683473|NCT01375764|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2683474|NCT01375764|Secondary|Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12|LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2683475|NCT01375764|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2683476|NCT01375764|Secondary|Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12|LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing data at Week 12 were imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2683477|NCT01375764|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing Apolipoprotein B at Week 12 was imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2683478|NCT01375764|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12|LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing Apolipoprotein B at Week 12 was imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2683479|NCT01375764|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing non-HDL-C at Week 12 was imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2683480|NCT01375764|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12|LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; missing non-HDL-C at Week 12 was imputed using LOCF.|||percent change||Standard Error|Least Squares Mean
2683481|NCT01375764|Secondary|Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evoloumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; Missing UC LDL-C at Week 12 was imputed using LOCF.|||mg/dL||Standard Error|Least Squares Mean
2683482|NCT01375764|Secondary|Change From Baseline in LDL-C at Week 12|LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; Missing UC LDL-C at Week 12 was imputed using LOCF.|||mg/dL||Standard Error|Least Squares Mean
2683483|NCT01375764|Primary|Percent Change From Baseline in LDL-C at Week 12: Ezetimibe Alone Versus Evolocumab + Ezetimibe|LDL-C was measured using ultracentrifugation. LS means are based off an ANCOVA model which includes treatment group (evolocumab + ezetimibe and ezetimibe alone) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; Missing UC LDL-C at Week 12 was imputed using LOCF and calculated LDL-C.|||percent change||Standard Error|Least Squares Mean
2683484|NCT01375764|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation. Least squares (LS) means are based off an analysis of covariance (ANCOVA) model which includes treatment group (3 evolocumab alone dose groups and the ezetimibe group) and stratification factors as covariates.|Baseline and Week 12|Full analysis set; Missing ultracentrifugation (UC) LDL-C at Week 12 was imputed using last observation carried forward (LOCF) and calculated LDL-C.|||percent change||Standard Error|Least Squares Mean
2683485|NCT01375751|Secondary|Percent Change From Baseline in Apolipoprotein B /Apolipoprotein A-1 Ratio at Week 12||Baseline and Week 12|Full analysis set; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
2683486|NCT01375751|Secondary|Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12||Baseline and Week 12|Full analysis set; LOCF imputaton was used.|||percent change||Standard Error|Least Squares Mean
2683487|NCT01375751|Secondary|Percent Change From Baseline in Apolipoprotein B at Week 12||Baseline and Week 12|Full analysis set; LOCF imputation was used|||percent change||Standard Error|Least Squares Mean
2683488|NCT01375751|Secondary|Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (HDL-C) at Week 12||Baseline and Week 12|Full analysis set; LOCF imputation was used.|||percent change||Standard Error|Least Squares Mean
2683489|NCT01375751|Secondary|Absolute Change From Baseline in LDL-C at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; LOCF imputation was used.|||mg/dL||Standard Error|Least Squares Mean
2683490|NCT01375751|Primary|Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12|LDL-C was measured using ultracentrifugation.|Baseline and Week 12|Full analysis set; Missing ultracentrifugation (UC) LDL-C data at Week 12 were imputed using last observation carried forward (LOCF) and calculated LDL-C.|||percent change||Standard Error|Least Squares Mean
2683491|NCT01375660|Secondary|Incident Diabetes||12 Months||||participants|||Number
2683492|NCT01375660|Post-Hoc|Change in Glycemia||12 Months||||percentage of participants|||Number
2685194|NCT01361633|Secondary|Trails B|Assesses executive functioning|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up|||||||
2683493|NCT01375660|Secondary|C-Peptidogenic Index-30|"Index of insulin secretion, higher index means higher insulin secretion. C-peptide circulates in blood in amounts equal to insulin because insulin and C-peptide are linked when first made by the pancreas. C-peptide is more stable in blood than insulin; therefore it can be reliably used to evaluate insulin secretion. It is calculated by a special formula using C-peptide and glucose measured at 0 min and at 30 min (hence 30 in the name) in Oral Glucose Tolerance test.~Insulin secretion was assessed based on formula C-Peptidogenic index-30 [(C-Peptide at 30 min - fasting C-peptide)/(glucose at 30 min - fasting glucose)]Bergstrom RW, Wahl PW, Leonetti DL, Fujimoto WY. Association of fasting glucose levels with a delayed secretion of insulin after oral glucose in subjects with glucose intolerance. J Clin Endocrinol Metab. 1990;71:1447-1453.)"|12 Month||||(ng/mL)/(mg/dL)||Standard Deviation|Mean
2683494|NCT01375660|Secondary|Insulinogenic Index-30|"Index of insulin secretion, higher index means higher insulin secretion. It is calculated by a special formula using insulin and glucose measured at 0 min and at 30 min (hence 30 in the name) in Oral Glucose Tolerance test.~Insulin secretion was assessed based on formula Insulinogenic index-30 [(insulin at 30 min - fasting insulin)/(glucose at 30 min - fasting glucose)] (Kosaka K, Hagura R, Kuzuya T. Insulin responses in equivocal and definite diabetes, with special reference to subjects who had mild glucose intolerance but later developed definite diabetes. Diabetes. 1977;26:944-952)"|12 Month||||(µU/mL)/(mg/dL)||Standard Deviation|Mean
2683495|NCT01375660|Secondary|Insulin Sensitivity by Matsuda Composite|"Insulin Sensitivity by Matsuda Composite - index of insulin sensitivity, higher index means higher insulin sensitivity. Low insulin sensitivity means high insulin resistance and high risk of type 2 diabetes mellitus. It is calculated by a special formula using insulin and glucose measured in Oral Glucose Tolerance test. The formula is different from a formula for OGIS.~Matsuda composite calculated based on formula 10^4/Square Root of [(fasting glucose x fasting insulin) x (mean glucose x mean insulin)] (Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic glucose clamp. Diabetes Care. 1999;22:1462-1470) Unit of measure is 10000/√[(µU/mL)/(mg/dL)]x[(µU/mL)/(mg/dL)]."|12 Months||||10^4/√[(µU/mL)/(mg/dL)x(µU/mL)/(mg/dL)]||Standard Deviation|Mean
2683496|NCT01375660|Secondary|Change in HbA1c From Baseline at 12 Months||Baseline and 12 Months||||percentage of A1C||Standard Deviation|Mean
2683497|NCT01375660|Primary|Oral Glucose Insulin Sensitivity (OGIS)|"Oral glucose insulin sensitivity = index of insulin sensitivity, higher index means higher insulin sensitivity. Low insulin sensitivity means high insulin resistance and high risk of type 2 diabetes mellitus. It is calculated by a special formula using insulin and glucose measured in Oral Glucose Tolerance test.~The primary outcome was the change in oral glucose insulin sensitivity (OGIS, from oral glucose tolerance test) after 12 months of treatment calculated as OGIS at 12-months minus OGIS baseline."|12 months||||ml/min/m^2 of body surface area||Standard Deviation|Mean
2683498|NCT01375608|Primary|The Percentage Change in HbF Level From Baseline to the Average Over the Final 1 Month of Study.||Final 1 month of study||||Participants|||Count of Participants
2683499|NCT01375569|Secondary|Count of Participants With Adverse Events|here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|25 months, 15 days||||Participants|||Count of Participants
2683500|NCT01375569|Primary|Time to Tumor Progression (TTP) for TRC105 in Hepatocellular Carcinoma (HCC).|Time to tumor progression is defined as the proportion of participants who are progression free after 4 months on study. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).|2 years||||Weeks||Full Range|Mean
2683501|NCT01375491|Secondary|CRP|Measure of global inflammation. Only the Doxycycline and Placebo arms are reported because the control group was not evaluated at Day 84.|Day 84|Only the Doxycycline and Placebo arms are reported because the control group was not evaluated at Day 84.|||microgram/ml||Standard Error|Mean
2683502|NCT01375491|Primary|MMP Activity|MMP activity is measured using a charge-changing peptide substrate for MMP-2 and MMP-9. Only the Doxycycline and Placebo arms are reported because the control group was not evaluated at Day 84.|Day 84|Only the Doxycycline and Placebo arms are reported because the control group was not evaluated at Day 84.|||uM 5-FAM/h-ug protein||Standard Error|Mean
2683503|NCT01375491|Secondary|CRP|Measure of global inflammation.|Baseline (Day 1)||||microgram/ml||Standard Error|Mean
2683504|NCT01375491|Primary|MMP Activity|MMP activity is measured using a charge-changing peptide substrate for MMP-2 and MMP-9.|Baseline (Day 1)||||uM 5-FAM/h-ug protein||Standard Error|Mean
2683505|NCT01375374|Secondary|Change in Total Cholesterol Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)|The change in total cholesterol levels from Baseline to the end of the Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement.|From Day 1 (Baseline) to Day 84 (Treatment Period End)|The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.|||mmol/L||Full Range|Median
2683506|NCT01375374|Secondary|Change in Serum Thyroid Hormone Free Thyroxine Level From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)|The change in the serum thyroid hormone free thyroxine level from Baseline to the end of the Maintenance Period was summarized descriptively by visit.|From Day 1 (Baseline) to Day 84 (Treatment Period End)|The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.|||pmol/L||Full Range|Median
2683507|NCT01375374|Secondary|Change in Sex Hormone Calculated Free Androgen Index Levels From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)|The change in sex hormone calculated free androgen index (100 x Testosterone/sex hormone binding globulin) levels from Baseline to the end of Maintenance Period was summarized descriptively by visit. A negative value indicates an improvement.|From Day 1 (Baseline) to Day 84 (Treatment Period End)|The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.|||Free Androgen Index||Full Range|Median
2683508|NCT01375374|Primary|Change in Serum Sex Hormone Binding Globulin (SHBG) From Baseline to Treatment Period End (Comprised of a 4-week Titration Period and an 8-week Maintenance Period)|Due to premature termination of enrollment prior to achieving the planned sample size (a total of 28 subjects), this primary safety variable was assessed for descriptive purposes only. A negative value indicates an improvement.|From Day 1 (Baseline) to Day 84 (Treatment Period End)|The Analysis Population refers to the Safety Set (SS). The SS consists of all subjects who received at least 1 dose of Lacosamide.|||nmol/L||Full Range|Median
2683509|NCT01375205|Post-Hoc|Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 24 Months|Percentage of cumulative Atopic Dermatitis diagnosed by any MD at 24 Months|24 Months|Number of participants analyzed captures only those participants still on study at 24 months.|||percentage of participants|||Number
2683510|NCT01375205|Secondary|Skin pH|Skin pH, as measured using a pH probe|2 month, 6 month, and 12 month visits|Number of participants analyzed captures only those participants that completed Skin pH testing at all time points. Not all participants noted in the overall participant flow were able to complete Skin pH testing either due to study status (i.e., lost to follow up, withdrawn) or missed visits.|||pH||Standard Deviation|Mean
2683511|NCT01375205|Secondary|Skin Hydration (Skin Electrical Capacitance)|Determination of stratum corneum hydration from the dorsal forearm|2 month, 6 month, and 12 month visits|Number of participants analyzed captures only those participants that completed skin hydration testing at all time points. Not all participants noted in the overall participant flow were able to complete skin hydration testing either due to study status (i.e., lost to follow up, withdrawn) or missed visits.|||farads||Standard Deviation|Mean
2683512|NCT01375205|Secondary|Transepidermal Water Loss (TEWL)|Transepidermal water loss (TEWL) to measure skin barrier function|2 month, 6 month, and 12 month visits|Number of participants analyzed captures only those participants that completed TEWL testing at all time points. Not all participants noted in the overall participant flow were able to complete TEWL testing either due to study status (i.e., lost to follow up, withdrawn) or missed visits.|||(g/[m2hr])||Standard Deviation|Mean
2683513|NCT01375205|Secondary|Filaggrin Mutation Status|Filaggrin mutation status result|6 month visit|Number of participants analyzed captures only those participants that completed 6 month filaggrin testing. Not all participants noted in the overall participant flow were able to complete filaggrin testing either due to study status (i.e., lost to follow up, withdrawn) or missed visit.|||Participants|||Count of Participants
2683514|NCT01375205|Secondary|Age at Onset of Eczema|Age of subject at onset of eczema|Baseline through Month 24 Follow-up||||months||Full Range|Median
2683515|NCT01375205|Secondary|Percentage of High Emollient Use|Patient-reported adherence to the emollient regimen in the intervention group and the treatment group. High emollient use was defined as applying the intervention or control emollient five or more days per week.|2, 6, 12, 18, and 24 months||||percentage of participants|||Number
2683516|NCT01375205|Primary|Percentage of Participants With Cumulative Atopic Dermatitis Diagnosed by Investigator at 12 Months|Percentage of cumulative Atopic Dermatitis diagnosed by a blinded investigator at 12 months|12 months|Around 28% of subjects enrolled were lost to follow-up by 12 months|||Percentage of participants|||Number
2683517|NCT01375140|Primary|Participants With Objective Response|To determine the efficacy of the combination of Ruxolitinib + Lenalidomide in patients with Myelofibrosis (MF). Objective response rate equals Complete and Partial Response, and Clinical Improvement as defined by International Working Group for Myelofibrosis Research and Treatment (IWG-MRT). Objective response rate (ORR), defined as a clinical improvement (CI), partial remission (PR), and complete remission (CR) according to the International Working Group (IWG) Criteria. Complete remission (CR): bone marrow blasts <5%, hemoglobin >/= 10, absolute neutrophil count (ANC) >/= 1000, platelets >/= 100, <2% immature myeloid cell, spleen and liver not palpable. Partial Response (PR): CR plus one or more of the following: ANC >/= 1000, decreased platelets by 50%, hemoglobin >/= 8.5 but < 10, <2% immature myeloid cells. Clinical improvement (CI): hemoglobin increase of 2g/dl, transfusion independence or reduction splenomegaly and/or hepatomegaly >/= 50%, >/=50% reduction in MPN-SAF TSS|3 cycles (28 days each) up to 3 months||||Participants|||Count of Participants
2683518|NCT01375127|Primary|Number of Participants Who Died||Baseline through Month 12|Safety analysis included all eligible participants who had provided an informed consent for this study.|||participants|||Number
2683519|NCT01375127|Primary|Number of Participants With Graft Failure|Graft failure which occurred within 12 months after the last dose of tofacitinib was reported. Graft failure was defined as graft nephrectomy, re-transplantation, or return to dialysis for greater than or equal to (>=) 6 consecutive weeks.|Baseline through Month 12|Safety analysis included all eligible participants who had provided an informed consent for this study.|||participants|||Number
2683520|NCT01375127|Primary|Number of Participants With Central Nervous System (CNS) Infection|Participants with CNS infection involving the brain or spinal cord, within 12 months after the last dose of tofacitinib were reported.|Baseline through Month 12|Safety analysis included all eligible participants who had provided an informed consent for this study.|||participants|||Number
2683521|NCT01375127|Primary|Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD)|All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported.|Baseline through Month 12|Safety analysis included all eligible participants who had provided an informed consent for this study.|||participants|||Number
2683522|NCT01375075|Primary|Percent Change From Baseline to 12 Weeks in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo|Percent change from baseline = 100*(post-baseline assessment - baseline assessment)/baseline assessment. Higher values in the percent change from baseline represented an improvement for HDL-C and lower values in the percent change from baseline represented an improvement for LDL-C. Least Squares (LS) mean was adjusted for baseline value of the variable analyzed.|Baseline and Week 12|All randomized participants who took at least 1 dose of double-blind study medication, had a baseline and at least 1 post-baseline HDL-C measurement [modified intent-to-treat (mITT) population], and also completed the Week 12 visit.|||percent change||Standard Error|Least Squares Mean
2684008|NCT01371305|Secondary|Time to Reach Maximum Observed Serum Concentration (Tmax) of BG00011||Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50|Pharmacokinetic (PK) population = Safety population.|||hours||Standard Deviation|Mean
2683523|NCT01375075|Secondary|Change From Baseline in Plasma CETP Mass|Plasma CETP mass assay was a solid-phase enzyme-linked immunosorbent assay (ELISA) designated to measure human CETP mass which employed the quantitative enzyme immunoassay principle. An increase in plasma CETP mass represented an improvement. LS mean was adjusted for baseline value of the variable analyzed.|Baseline, Weeks 4, 8, and 12|All randomized participants who took at least 1 dose of double-blind study medication, had a baseline and at least 1 post-baseline HDL-C measurement (mITT population), and had at least 1 post-baseline CETP mass measurement.|||micrograms per milliliter (µg/mL)||Standard Error|Least Squares Mean
2683524|NCT01375075|Secondary|Percent Change From Baseline in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity|Plasma CETP activity assay employed a fluorometric method to determine the CETP transfer activity. Percent change from baseline = 100*(post-baseline assessment - baseline assessment)/baseline assessment. An increase in the percent change from baseline represented an improvement. LS mean was adjusted for baseline value of the variable analyzed.|Baseline, Weeks 4, 8, and 12|All randomized participants who took at least 1 dose of double-blind study medication, had a baseline and at least 1 post-baseline HDL-C measurement (mITT population), and had at least 1 post-baseline CETP activity measurement.|||percent change in CETP activity||Standard Error|Least Squares Mean
2683525|NCT01375075|Secondary|Change From Baseline to 12 Week Endpoint in Highly-Sensitive C-Reactive Protein (hsCRP)|LS mean was adjusted for baseline value of the variable analyzed.|Baseline and Week 12|All randomized participants who took at least 1 dose of double-blind study medication, had a baseline and at least 1 post-baseline HDL-C measurement (mITT population), and had at least 1 post-baseline hsCRP measurement.|||milligrams per deciliter (mg/dL)||Standard Error|Least Squares Mean
2683526|NCT01375075|Secondary|Number of Myopathy and Liver Injury Events|Myopathy events were considered muscle-related treatment emergent adverse events (TEAEs) and liver injury events were considered hepatic disorder-related TEAEs reported per Medical Dictionary for Regulatory Activities (MedDRA). An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs were newly occurring AEs or AEs worsening after first dose.|Baseline through Week 12|All randomized participants who took at least 1 dose of double-blind study medication (ITT population).|||events|||Number
2683527|NCT01375075|Secondary|Change From Baseline to 12 Weeks in Serum Bicarbonate|LS mean was adjusted for baseline value of the variable analyzed.|Baseline and Week 12|All randomized participants who took at least 1 dose of double-blind study medication (ITT population) and had a baseline and at least 1 post-baseline serum bicarbonate measurement.|||milliequivalents per liter (mEq/L)||Standard Error|Least Squares Mean
2683528|NCT01375075|Secondary|Change From Baseline to 12 Weeks in Serum Sodium|LS mean was adjusted for baseline value of the variable analyzed.|Baseline and Week 12|All randomized participants who took at least 1 dose of double-blind study medication (ITT population) and had a baseline and at least 1 post-baseline serum sodium measurement.|||milliequivalents per liter (mEq/L)||Standard Error|Least Squares Mean
2683529|NCT01375075|Secondary|Change From Baseline to 12 Weeks in Plasma Renin Activity|LS mean was adjusted for baseline value of the variable analyzed.|Baseline and Week 12|All randomized participants who took at least 1 dose of double-blind study medication (ITT population) and had a baseline and at least 1 post-baseline plasma renin activity measurement.|||nanograms per milliliter per hour||Standard Error|Least Squares Mean
2683530|NCT01375075|Secondary|Change From Baseline to 12 Weeks in Aldosterone|LS mean was adjusted for baseline value of the variable analyzed.|Baseline and Week 12|All randomized participants who took at least 1 dose of double-blind study medication (ITT population) and had a baseline and at least 1 post-baseline aldosterone measurement.|||nanograms per deciliter (ng/dL)||Standard Error|Least Squares Mean
2683531|NCT01375075|Secondary|Change From Baseline to 12 Weeks in Blood Pressure|"Blood pressure reported as systolic blood pressure (SBP) and diastolic blood pressure (DBP).~LS mean was adjusted for baseline value of the variable analyzed."|Baseline and Week 12|All randomized participants who took at least 1 dose of double-blind study medication (ITT population) and had a baseline and at least 1 post-baseline value of the response variable.|||millimeters of mercury (mm Hg)||Standard Error|Least Squares Mean
2683532|NCT01375075|Secondary|The Number and Severity of Episodes of Rashes at Any Time From Baseline Through Week 12|All rash cases were adjudicated by a central dermatologist blinded to treatment assignment according to a study-specific Clinical Events Committee (CEC) charter. Rash events were assessed according to clinical relevance (severity). Categories included high risk, low risk, not a relevant dermatosis, or insufficient documentation for determination. High risk rashes included anaphylaxis, toxic epidermal necrolysis, Stevens Johnson Syndrome, Drug Reaction with Eosinophilia and System Symptoms (DRESS), urticaria/angioedema, vasculitis, erythroderma, and lupus-like reaction. All other rashes were considered low risk or not a relevant dermatosis per the Investigator's clinical opinion. A participant could be reported in multiple categories.|Baseline through Week 12|All randomized participants who took at least 1 dose of double-blind study medication intent-to-treat (ITT) population.|||events|||Number
2683533|NCT01375075|Secondary|Pharmacokinetics - Area Under the Curve (AUC) of LY2484595 and Atorvastatin||Weeks 2, 4, 8, 12 (predose and postdose), and Week 16|Participants who were administered LY2484595 or LY2484595 + Atorvastatin and had evaluable pharmacokinetic (PK) samples.|||nanograms*hours per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2683534|NCT01375075|Secondary|Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin|Percent change from baseline = 100*(post-baseline assessment - baseline assessment)/baseline assessment. An increase in the percent change from baseline represented an improvement for HDL-C and a decrease in the percent change from baseline represents an improvement for LDL-C. LS mean was adjusted for baseline value of the variable analyzed.|Baseline, Weeks 2, 4, and 8|All randomized participants who took at least 1 dose of double-blind study medication, had a baseline and at least 1 post-baseline HDL-C measurement (mITT population), and had at least 1 post-baseline value of the response variable for the specified time frame.|||percent change||Standard Error|Least Squares Mean
2683535|NCT01375049|Primary|Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Sensitivity Analysis Set)|The percentage of participants with PA-negative cultures at all time points after cessation of active treatment at Day 28 (assessed at Days 56, 112, and 196) was summarized for the Sensitivity Analysis Set.|Day 28 to Day 196|Sensitivity Analysis Set|||percentage of participants||95% Confidence Interval|Number
2683536|NCT01375049|Secondary|Pharmacokinetics (PK) Peak and Trough Plasma Concentrations of Aztreonam|The plasma concentration of aztreonam for participants < 6 years of age was obtained 1 hour after the first dose of AZLI on Day 1 and immediately prior to the last dose of AZLI on Day 28.|Day 1 (1 hour postdose) and Day 28 (immediately prior to dosing)|Participants in the Full Analysis Set < 6 years of age with evaluable PK profiles were analyzed.|||ng/mL||Standard Deviation|Mean
2683537|NCT01375049|Secondary|Change From Baseline in Body Mass Index (BMI)||Baseline to Days 28, 56, 112, and 196|Full Analysis Set|||kg/m^2||Standard Deviation|Mean
2683538|NCT01375049|Secondary|Change From Baseline in Height||Baseline to Days 28, 56, 112, and 196|Full Analysis Set|||cm||Standard Deviation|Mean
2683539|NCT01375049|Secondary|Change From Baseline in Weight||Baseline to Days 28, 56, 112, and 196|Full Analysis Set|||kg||Standard Deviation|Mean
2683540|NCT01375049|Secondary|Use of Additional (Non-study) Antipseudomonal Antibiotics|The percentage of participants who used additional (non-study) antipseudomonal antibiotics (an indication of PA exacerbation) while on treatment and posttreatment was summarized.|Baseline to Day 196|Full Analysis Set|||percentage of participants|||Number
2683541|NCT01375049|Secondary|Percentage of Participants With PA-negative Cultures|The percentage of participants with a PA-negative culture was summarized at each visit.|Days 28, 56, 112, and 196|Participants from the Full Analysis Set who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course were included in the analysis at all time points.|||percentage of participants|||Number
2683542|NCT01375049|Secondary|Change From Baseline in CFQ-R RSS Score|Respiratory symptoms (eg, coughing, congestion, wheezing) were assessed with the Cystic Fibrosis Questionnaire - Revised (CFQ-R) Respiratory Symptoms Scale (RSS) only in participants ≥ 6 years of age. The range of scores (units) is 0 to 100 with higher scores indicating fewer symptoms.|Baseline to Days 28, 56, 112, and 196|Participants in the Sensitivity Analysis Set ≥ 6 years of age with available data for this assessment were analyzed.|||units on a scale||Standard Deviation|Mean
2683543|NCT01375049|Secondary|Change From Baseline in FEV1% Predicted|Spirometry assessments were performed only in participants ≥ 6 years of age. Forced expiratory volume in 1 second (FEV1) % predicted was defined as FEV1 of the participant divided by the average FEV1 in the population for any person of similar age, sex and body composition.|Baseline to Days 28, 56, 112, and 196|Participants in the Sensitivity Analysis Set ≥ 6 years of age with available data for this assessment were analyzed.|||percentage of FEV1% predicted||Standard Deviation|Mean
2683544|NCT01375049|Primary|Percentage of Participants With PA-negative Cultures at All Time Points After Cessation of Active Treatment (Evaluable Analysis Set)|The percentage of participants with PA-negative cultures at all time points after cessation of active treatment at Day 28 (assessed at Days 56, 112, and 196) was summarized for the Evaluable Analysis Set.|Day 28 to Day 196|Evaluable Analysis Set|||percentage of participants||95% Confidence Interval|Number
2683545|NCT01375010|Secondary|Change in Biochemical Markers|To evaluate the effect of vitamin D and calcium supplementation on biochemical markers of bone turnover and markers of inflammation. (PTH)|12 months|A complete case approach was utilized for secondary outcomes in participants with data at 12 months (n=69).|||percentage of change||Standard Deviation|Mean
2683546|NCT01375010|Secondary|Change in Vitamin D Levels|To evaluate the change in vitamin D levels with supplementation|12 months|A complete case approach was utilized for secondary outcomes in participants with data at 12 months (n=69).|||percentage of change||Standard Deviation|Mean
2683547|NCT01375010|Secondary|Change in Volumetric Bone Mineral Density (vBMD)|To evaluate the change in volumetric BMD (VBMD) at the Tibia|Baseline, 12 months|A complete case approach was utilized for secondary outcomes in participants with vBMD data at 12 months (n=69).|||percentage of change||Standard Deviation|Mean
2683548|NCT01375010|Secondary|Areal Change in Bone Mineral Density (aBMD)|To evaluate the change in areal BMD (aBMD) at the total hip (TH)|Baseline,12 months|A complete case approach was utilized for outcome in participants with BMD data at 12 months (n=69).|||percentage of change||Standard Deviation|Mean
2683549|NCT01375010|Primary|Change in Bone Mineral Density (BMD)|Percent change from baseline in BMD at lumbar spine (as measured by Dual-emission X-ray absorptiometry (DXA) scan) at 12 months|Baseline, 12 months|A complete case approach was utilized for outcome in participants with BMD data at 12 months (n=69).|||percentage change||Standard Deviation|Mean
2683550|NCT01374971|Secondary|Percent Change From Screening in Disease Activity Score (DAS) 28 ESR After 14 Weeks of Treatment|The DAS 28 ESR is a score calculated from the results of a 28-count joint assessment (total number of tender joint possible is 28, and total number of swollen joints possible is 28), the Erythrocyte Sedimentation Rate (ESR), and the Patient Global Assessment (measured using a 100 mm visual analogue scale, with the lowest possible score of 0 mm meaning the subject is not affected at all by arthritis and the highest possible score of 100 mm meaning the subject is severely affected by arthritis). A lower DAS 28 ESR indicates less active disease, and a higher DAS 28 ESR indicates more active disease. The DAS 28 ESR was calculated for each subject at the screening visit and at the Week 14 final visit. The percent change was then calculated for each patient, and a mean percent change for all subjects was determined.|Screening and Week 14||||percent change||Standard Deviation|Mean
2683551|NCT01374971|Primary|Percent Change From Baseline in Synovial TNFa, CXCL13, IL-8, IL-6, IL-1b, IL-10, IP-10, BCL3, CD3E, DUSP4, FOXP3, CD79A, CD138, MMP-3, and MMP-1 After 12 Weeks of Treatment With Certolizumab Pegol (CZP) in Patients With Rheumatoid Arthritis|Synovial tissue biopsy samples were taken at baseline and at 12 weeks after starting treatment with CZP. These samples were analyzed to determine the concentrations of select biomarkers and to determine the percent change in concentration from baseline to week 12.|Baseline and Week 12||||Percent change||95% Confidence Interval|Geometric Mean
2683552|NCT01374919|Secondary|Number of Participants With Treatment Related Serious Adverse Events. Calls for Minor Side Effects Will Occur at 24 and 48 Hours and One Week. A Followup Visit Will Occur at 4 Weeks.||immediate, 24 and 48 hours, one week and followup visit at 4 weeks||||participants|||Number
2683553|NCT01374919|Primary|Efficacy of 1020 mg of Ferumoxytol Over 15 Minutes. Hemoglobin Measurements Will Take Place at Four and Eight Week Visit.|Percentage of participates with indicated increase in hemoglobin from baseline to week 4 and week 8|baseline 4 weeks and 8 weeks|Two patients had minor infusion reactions and refused rechallenge. All other patients completed the study. Their hemoglobin levels, the primary outcome, were obtained at 4 and 8 weeks.|||percentage of participants|||Number
2683554|NCT01374906|Secondary|Actual Change in SF-12v2 Score From Baseline - Physical Component Summary|SF-12v2 General Health Survey is a general patient reported outcome instrument over time. It is scored to provide eight health domain scores (Bodily Pain (BP), General Health (GH), Physical Functioning (PF), Role-Physical (RP), Social Functioning (SF), Role-Emotional (RE), Vitality (VT) and Mental Health (MH)). These eight domain scores can be combined to form two summary scores reflecting overall physical and mental health: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The analyses reported here focus on PCS and MCS scores. The domain scores use a norm-based score, which standardizes the scores with respect to the mean and standard deviation of a nationally representative sample of United States (US) adults. These are the scores on the original scale which have not been transformed in any way. The possible range of scores is 0 to 100, with higher scores representing better outcomes.|Months 7, 12 & 24|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||scores on a scale||Standard Deviation|Mean
2683555|NCT01374906|Secondary|Actual Change in SF-12v2 Score From Baseline - Mental Component Summary|SF-12v2 General Health Survey is a general patient reported outcome instrument over time. It is scored to provide eight health domain scores (Bodily Pain (BP), General Health (GH), Physical Functioning (PF), Role-Physical (RP), Social Functioning (SF), Role-Emotional (RE), Vitality (VT) and Mental Health (MH)). These eight domain scores can be combined to form two summary scores reflecting overall physical and mental health: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The analyses reported here focus on PCS and MCS scores. The domain scores use a norm-based score, which standardizes the scores with respect to the mean and standard deviation of a nationally representative sample of United States (US) adults. These are the scores on the original scale which have not been transformed in any way. The possible range of scores is 0 to 100, with higher scores representing better outcomes.|Months 7, 12 & 24|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||scores on a scale||Standard Deviation|Mean
2683556|NCT01374906|Secondary|Actual Change in Standardized Score of Cushing's Disease HRQoL (CushingQOL) Score From Baseline|CushingQol is a disease-specific patient-reported outcome instrument. It is a single-domain 12 item Cushing's disease quality of life instrument. The Cushing's syndrome quality of life (CushingQoL) questionnaire is a single domain questionnaire which includes 12 self-report items scored using a five point Likert scale anchored at (1=always/very much and 5=never/not at all). The patient is asked to report what they think or feel about their Cushing's syndrome and how much the illness has interfered in usual activities over the past 4 weeks. The total score is standardized on a 0-100 scale with lower scores indicating a greater impact on quality of life.|Months 7, 12, 24 & 36|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||scores on a scale||Standard Deviation|Mean
2683557|NCT01374906|Secondary|Pharmacokinetic (PK) Parameter: Cmax|"Pasireotide peak levels (Cmax) was one of the parameters used for PK assessments. Cmax is the post-dose PK concentration with an elapsed time from the previous injection of 21+/-2 days. All patients randomized to the study had at least one PK observation and were therefore included in the pharmacokinetic analysis set (PAS). Cmax PK observations (Day 20 and Day 104) with an elapsed time from the previous injection outside of 21+/-2 days window were excluded. Given that SOM230 LAR was administered once a month, the Cmax were collected every 28 days in this study, thus this provides a summary of Cmax values provided by incident dose (last dose administered prior to PK sample collection), not by randomized dose, hence each column is equivalent to an incident dose and not an arm/group. Patients randomized to either the 10mg or 30mg could be titrated down to 5mg due to safety, or titrated up to 40mg, hence the 4 incident doses/columns that were allowed per protocol during this study."|Days 22, 106, 190|"Pharmacokinetic analysis set (PAS): The PAS consists of all randomized patients who have received at least one dose of study drug and had at least one post dosing PK assessment.~Patients were analyzed according to incident dose (defined as the last dose prior to the PK sample)."|||ng/mL||Standard Deviation|Mean
2683558|NCT01374906|Secondary|Pharmacokinetic (PK) Parameter: Ctrough|Pasireotide trough levels (Ctrough) was 1 of the parameters used for PK assessments. Ctrough is the pre-dose PK concentration with an elapsed time from previous injection of 28+/-2 days. All patients randomized to the study had at least 1 PK observation & were therefore included in the pharmacokinetic analysis set. PK observations with missing concentrations, missing dose, missing elapsed time or an elapsed time from previous injection outside of 28 ±2 days window were excluded. Given that SOM230 LAR was administered once a month, Ctrough was collected every 28 days and thus this provides a summary of Ctrough values provided by incident dose (last dose administered prior to PK sample collection), not by randomized dose, hence each column is equivalent to an incident dose & not an arm/group. Patients randomized to either 10mg or 30mg could be titrated down to 5mg due to safety, or titrated up to 40mg, hence the 4 incident doses/columns that were allowed per protocol during this study.|Days 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337|"Pharmacokinetic analysis set (PAS): The PAS consists of all randomized patients who have received at least one dose of study drug and had at least one post dosing PK assessment.~Patients were analyzed according to incident dose (defined as the last dose prior to the PK sample)."|||ng/mL||Standard Deviation|Mean
2683559|NCT01374906|Secondary|Percent of Participants With a Duration of at Least 50% Reduction in mUFC From Baseline at Indicated Time Points|Duration of 50% reduction from baseline is defined as the period starting from the date of patient's first 50% reduction from baseline|Months 6, 12 & 18|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2683560|NCT01374906|Secondary|Percent of Participants Attaining a Time to First Achievement of at Least a 50% Reduction in mUFC From Baseline at Indicated Time Points|Time to first achievement of a 5by randomized groups.0% reduction in mUFC from baseline|every month in the core phase and every 3 months in the extension phase) up to and including the cut-off date for the Month 12 CSR (10-Nov-2015)|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2683577|NCT01374906|Secondary|Percentage of Patients Who Attain mUFC ≤1.0 x ULN or Have at Least 50 % Reduction From Baseline in mUFC|Controlled responder: mUFC ≤ 1.0×ULN. Partially controlled responder: at least 50% reduction in mUFC from Baseline, and mUFC >1.0×ULN.|M7, M12, M24, M36|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2683561|NCT01374906|Secondary|Percentage of Patients That Attain a Reduction of at Least 50% in mUFC From Baseline|"All of the participants who discontinued prior to month 4 evaluations were classed as non-responders. For participants missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value.~Analysis split by screening strata of mUFC~Stratum 1:"|Months 7, 12, 24 & 36|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2683562|NCT01374906|Secondary|Percentage of Participants That Attained a Mean Urinary Free Cortisol (mUFC) <= 1.0 x Upper Limit of Normal (ULN) at Month 7 Regardless of Dose Up-titration at Month 4.|"All of the participants who discontinued prior to month 4 evaluations were classed as non-responders. For participants missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value.~Analysis split by screening strata of mUFC Stratum 1: mUFC 1.5x to < 2.0 x ULN Stratum 2: mUFC 2.0x to <= 5.0 x ULN"|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2683563|NCT01374906|Secondary|Percentage of Participants Having a Favorable Shift From Baseline in Clinical Signs|This includes patients with improvements in symptoms from baseline. Clinical signs over time include: facial rubor, fat pads, hirsutism, striae, (via photographs by a second local physician who was blinded to the treatment dose and time point of the photograph) and muscle strength.|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||Percentage of participants|||Number
2683564|NCT01374906|Secondary|Percentage Change From Baseline in Clinical Signs Over Time|Percentage change in parameter measurements: blood pressure, body mass index, waist circumference, fasting serum lipid profile, weight, bone density and body composition (examined by DXA scan) from Baseline|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||Percentage change||Standard Deviation|Mean
2683565|NCT01374906|Secondary|Actual Change From Baseline in Clinical Signs Over Time: Cholesterol & Triglycerides|Change in parameter measurements: cholesterol & triglycerides from Baseline|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||mmol/L||Standard Deviation|Mean
2683566|NCT01374906|Secondary|Actual Change From Baseline in Clinical Signs Over Time: Waist Circumference|Change in waist circumference measurements from Baseline|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||cm||Standard Deviation|Mean
2683567|NCT01374906|Secondary|Actual Change From Baseline in Clinical Signs Over Time: Body Composition: Region|Change in body composition: region measurements from Baseline|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage fat||Standard Deviation|Mean
2683568|NCT01374906|Secondary|Actual Change From Baseline in Clinical Signs Over Time: Weight|Change in weight measurements from Baseline|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||kg||Standard Deviation|Mean
2683569|NCT01374906|Secondary|Actual Change From Baseline in Clinical Signs Over Time: Body Mass Index (BMI)|Change in BMI measurements from Baseline|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||kg/m2||Standard Deviation|Mean
2683570|NCT01374906|Secondary|Actual Change From Baseline in Clinical Signs Over Time: Blood Pressure|Change in blood pressure measurements from Baseline|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||mmHg||Standard Deviation|Mean
2683571|NCT01374906|Secondary|Percentage Change From Baseline on Serum Cortisol Over Time|Percentage change in serum cortisol (nmol/L) from Baseline by randomized groups.|Months 7, 12, 24 & 36|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||Percentage change||Standard Deviation|Mean
2683572|NCT01374906|Secondary|Percentage Change From Baseline on Plasma Adrenocorticotropic Hormone (ACTH) Over Time|Percentage change in ACTH (pmol/L) from Baseline by randomized groups.|Months 7, 12, 24 & 36|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||Percentage change||Standard Deviation|Mean
2683573|NCT01374906|Secondary|Percent of Participants Attaining a Duration of Controlled or Partially Controlled Response at Indicated Time Points|Duration of controlled or partially controlled response is defined as the period starting from the date of patient's first normalization (mUFC≤ 1.0 x ULN) or at least 50% reduction from baseline up to the date when the patient's mUFC >1.0 x ULN and the reduction from baseline falls to less than 50% for the first time.|Month 6, 12, 18|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2683574|NCT01374906|Secondary|Percent of Participants Attaining a mUFC ≤ 1.0 x ULN or at Least a 50% Reduction in mUFC From Baseline at Indicated Time Points|Time to first achievement of attaining a mUFC ≤ 1.0 x ULN or at least a 50% reduction in mUFC from baseline by randomized groups.|Momth 7, Month 12|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||Percentage of participants||95% Confidence Interval|Number
2683575|NCT01374906|Secondary|Percentage of Patients With Uncontrolled Response at Month 7 & Month 12 Within the Subset of Patients Who Had Uncontrolled Response at a) Months 1 and 2; b) Months 1, 2, and 3|Percentage of patients with mUFC > 1.0 xULN at Month 7 and Month 12 within the subset of patients who were uncontrolled at a) Months 1 & 2, b) Months 1, 2, & 3 by randomized groups.|Month 7, Month12|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage of participants|||Number
2683576|NCT01374906|Secondary|Percentage of Patients Who Are Controlled Responders (mUFC ≤ 1.0 xULN) on at Least 4 of the 7 mUFC Assessments by Month 7 & on at Least 7 of the 12 mUFC Assessments by Month 12.|Percentage of patients with mUFC ≤ 1.0 x ULN at a minimum of 4 months up to and including Month 7, and at a minimum of 7 months up to and including Month 12 by randomized groups.|Month 7, Month 12|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2686525|NCT01349816|Secondary|Peak Change From Baseline in FEV1|Peak change from baseline in FEV1 through 2 hours|Day 1|MITT Population|||Liters||95% Confidence Interval|Least Squares Mean
2683581|NCT01374906|Secondary|Percentage of Participants That Attained a mUFC ≤ 1.0 x ULN at Month 7 and Had Not Had a Dose Increase at Month 4|"Percentage of participants that attain a mUFC ≤ 1.0×ULN at Month 7 and had not had a dose increase at Month 4. Patients who had a dose increase prior to Month 7 were counted as non-responders in this analysis.~Patients who discontinued before month 4 evaluations classed as non-responders. For patients missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value.~A responder was defined as a patient who attains mUFC ≤1.0 X ULN and had not had a dose increase at Month 4."|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2683582|NCT01374906|Primary|Percentage Participants That Attained a mUFC ≤ 1.0 x ULN at Month 7 Regardless of Dose Titration|Percentage of participants that attained a mean urinary free cortisol (mUFC) <= 1.0 x upper limit of normal (ULN) at Month 7 regardless of dose up-titration at Month 4. Patients who discontinued before month 4 evaluations classed as non-responders. For patients missing month 7 mUFC assessments, the last available mUFC assessment at or after month 4 was carried forward as the month 7 mUFC assessment value.|Month 7|Full analysis set (FAS): The FAS comprises all randomized patients who received at least one dose of study drug.|||percentage of participants||95% Confidence Interval|Number
2683583|NCT01374802|Secondary|Tmax,ss of Darunavir|time from last dosing to maximum concentration of the analyte in plasma at steady state|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)|PK set|||h||Full Range|Median
2683584|NCT01374802|Primary|Cmax,ss of Darunavir|maximum measured concentration of the analyte in plasma at steady-state|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2683585|NCT01374802|Primary|Cτ,ss of Darunavir|concentration of the analyte in plasma at steady-state after a uniform dosing interval τ=24h of darunavir|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 h after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)|PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2683586|NCT01374802|Primary|AUCτ,ss of Darunavir|"area under the concentration-time curve of the analyte in plasma at steadystate over a uniform dosing interval τ of darunavir.~The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities"|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00,12:00 hours (h) after drug administration on day 8 (DRV/r) and day 16 (BI 201335+DRV/r)|Pharmacokinetic (PK) set: all subjects in the treated set who provided at least one observation for at least one primary endpoint without any important protocol violations relevant to the pharmacokinetic evaluation and who did not experience vomiting at or before 2 times median tmax.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2683587|NCT01374568|Primary|Bone Turnover in Subjects Treated With Sitagliptin When Compared to Those Treated With Placebo|Bone turnover assessed using change in bone-specific alkaline phosphatase (BAP) over 8 weeks of treatment.|8 WEEKS|The difference between the bone turnover markers bone alkaline phosphatase (BAP) from baseline to end of study were calculated for treatment and placebo groups. Serum samples were not available for one placebo participant at baseline and for one placebo patient at end of study.|||mg/L||Standard Deviation|Mean
2683588|NCT01374568|Primary|Bone Turnover in Subjects Treated With Sitagliptin When Compared to Those Treated With Placebo.|Bone turnover assessed using change in TRACP5b over 8 weeks of treatment.|8 weeks|The difference between the bone turnover markers TRACP5b from baseline to end of study were calculated for treatment and placebo groups. Serum samples were not available for one placebo participant at baseline and for one placebo patient at end of study. As a result we were unable to analyze the 2 participants with missing data.|||U/L||Standard Deviation|Mean
2683589|NCT01374516|Secondary|Number of Participants With Solicited Systemic Reactions Following Any and Each Injection With Either CYD Dengue Vaccine or a Placebo|Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever: >= 39°C; Headache, Malaise, Myalgia, and Asthenia: significant, prevents daily activity.|Within 14 days after each and any injection|Solicited systemic reactions were assessed in a subset of the Safety Analysis Set, which included all participants who received at least one dose of study vaccine and who were evaluated for reactogenicity. Here, 'number analyzed' = participants with available data for specified category.|||Participants|||Number
2683590|NCT01374516|Secondary|Number of Participants With Solicited Injection Site Reactions Following Any and Each Injection With Either CYD Dengue Vaccine or a Placebo|Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions (9-11 years): Pain: incapacitating, unable to perform usual activities; Erythema and Swelling, >= 50 mm. Grade 3 Solicited injection site reactions (12-16 years): Pain: significant, prevents daily activity; Erythema and Swelling, >100 mm.|Within 7 days after each and any injection|Solicited injection site reactions were assessed in a subset of the Safety Analysis Set, which included all participants who received at least one dose of study vaccine and who were evaluated for reactogenicity. Here, ‘number analyzed’ = participants with available data for specified category.|||Participants|||Number
2683591|NCT01374516|Secondary|Geometric Mean Titers of Antibodies Against Each Dengue Virus Serotype Before and Following Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo|Geometric mean titers for each of the 4 dengue virus serotypes (parental strains) were assessed using the plaque reduction neutralization test in a pre-defined subset of participants.|Pre-injection 1, 28 days post Injections 2 and 3, 13 months (V 07) and 60 months (V 12) post-injection 3|Antibody titers against each dengue virus serotype strain were assessed in FASI, which included a subset of participants who received at least one dose of vaccine and had a blood sample drawn and result available after the dose. Here,‘number analyzed’ = participants with available data for each specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2683609|NCT01374451|Secondary|PFS and the Predictive Probability of Success in Phase III|105 PFS events expected after approximately 36 months|Once 105 PFS events had occurred occurred|Since the study was terminated because the study did not meet its primary objective which was based on PFS as per local radiology assessment, minimal efficacy data was obtained. Only 80 PFS events occurred before study was terminated so 105 PFS events was not reached to analyze this data.||||||
2683592|NCT01374516|Secondary|Percentage of Participants With Antibody Titers >=10 1/Dil Against Each Dengue Virus Serotype Before and Following Injection (Inj.) With CYD Dengue Vaccine or Placebo|Dengue neutralizing antibody levels against each of the 4 dengue virus serotypes (parental strains) were measured by the plaque reduction neutralization test in a pre-defined subset of participants.|Pre-injection 1, 28 days post Injections 2 and 3, 13 months (Visit [V] 07) and 60 months (Visit [V] 12) post-injection 3|Antibody titers against each dengue virus serotype strain were assessed in Full Analysis Set for Immunogenicity(FASI),which included a subset of participants who received at least one dose of vaccine and had a blood sample drawn and result available after the dose.Here, ‘number analyzed’=participants with available data for each specified category.|||Percentage of participants|||Number
2683593|NCT01374516|Secondary|Number of Clinically Severe VCD Cases During the Surveillance Expansion Period Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo|The severity of VCD cases was assessed by an IDMC based on a medical review of cases and any of the following criteria:-1) Platelet count <=100000 /μl and bleeding (tourniquet, petechiae or any bleeding) plus plasma leakage 2) Shock (pulse pressure <= 20 mmHg in a child, or hypotension [<= 90 mmHg] with tachycardia, weak pulse and poor perfusion) 3) Bleeding requiring blood transfusion 4) Encephalopathy i.e. Unconsciousness or poor conscious state or fitting not attributable to simple febrile convulsion or focal neurological signs. Poor conscious state or unconsciousness must be supported by GCS score 5) Liver impairment (AST >1000 IU/L or PT INR >1.5) excluding other causes of viral hepatitis 6) Impaired kidney function (serum creatinine >= 1.5 mg/dL) 7) Myocarditis, pericarditis or clinical heart failure supported by CXR, echocardiography, ECG or cardiac enzymes.|From consent to participate in the Surveillance Expansion Period to the end of study (up to 72 months)|Number of clinically severe VCD cases were assessed in the Full Analysis Set for Surveillance Expansion Period. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||Cases|||Number
2683594|NCT01374516|Secondary|Number of Clinically Severe VCD Cases Throughout the Trial Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo|The severity of VCD cases was assessed by an Independent Data monitoring Committee (IDMC) based on a medical review of cases and any of the following criteria:1) Platelet count <=100000 /μl and bleeding (tourniquet, petechiae or any bleeding) plus plasma leakage 2) Shock (pulse pressure <= 20 mmHg in a child, or hypotension [<= 90 mmHg] with tachycardia, weak pulse and poor perfusion) 3) Bleeding requiring blood transfusion 4) Encephalopathy i.e. unconsciousness or poor conscious state or fitting not attributable to simple febrile convulsion or focal neurological signs. Poor conscious state or unconsciousness must be supported by Glasgow Coma Scale (GCS) score 5) Liver impairment (AST >1000 IU/L or prothrombin time [PT] International normalized ratio [INR] >1.5) excluding other causes of viral hepatitis 6) Impaired kidney function (serum creatinine >= 1.5 mg/dL) 7) Myocarditis, pericarditis or clinical heart failure supported by CXR, echocardiography, ECG or cardiac enzymes.|Day 0 to the end of study (up to 72 months)|Number of clinically severe VCD cases were assessed in the Safety Analysis Set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||Cases|||Number
2683595|NCT01374516|Secondary|Number of Hospitalized VCD Cases During the Surveillance Expansion Period Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo|Hospitalized VCD cases were defined as VCD confirmed by dengue RT-PCR and/or dengue NS 1 ELISA in participants with acute febrile illness (temperature >=38°C on at least 2 consecutive days) requiring hospitalization.|From consent to participate in the Surveillance Expansion Period to end of the study (up to 72 months)|Analysis was performed in the Safety Analysis Set.|||Cases|||Number
2683596|NCT01374516|Secondary|Number of Hospitalized VCD Cases Throughout the Trial Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo|Hospitalized VCD cases were defined as VCD confirmed by dengue RT-PCR and/or dengue NS 1 ELISA in participants with acute febrile illness (temperature >=38°C on at least 2 consecutive days) requiring hospitalization.|Day 0 up to the end of study (up to 72 months)|Number of hospitalized dengue hemorrhagic fever cases were assessed in the Safety Analysis Set. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||Cases|||Number
2683597|NCT01374516|Secondary|Number of Symptomatic VCD Cases Meeting WHO Criteria During the Surveillance Expansion Period Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo|The 1997 WHO criteria are: a) Fever: acute onset, high (>= 38°C) and continuous, for 2 to 7 days and (b) any of the following: thrombocytopenia (platelet <=100 x 109/L) and plasma leakage as shown by hematocrit increased by 20% or more or pleural effusion and/or ascites and/or hypoalbuminemia. The first two clinical criteria plus thrombocytopenia and signs of plasma leakage are enough to establish diagnosis of DHF. DHF was graded as follows: Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test; Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participant, usually in the form of skin and/or other hemorrhages; Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness; and Grade IV: Profound shock with undetectable blood pressure and pulse.|From consent to participate in the Surveillance Expansion Period to the end of study (up to 72 months)|Number of WHO dengue hemorrhagic fever cases were assessed in the Full Analysis Set for Surveillance Expansion Period, which included all participants who received at least 1 injection and accepted to be included in the Surveillance Expansion Period.|||Cases|||Number
2683610|NCT01374451|Secondary|Overall Survival (OS) Using Kaplan Meier Method|Overall survival was defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient is not known to have died, survival was to be censored at the date of last contact.|Once 80 PFS events had occurred|The FAS consisted of all randomized patients.1 patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems. The study was terminated because the study did not meet its primary objective so minimal efficacy data was obtained.|||Percentage of participants||95% Confidence Interval|Number
2683827|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 84|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 84 measurement.|Day 84|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.|||participants|||Number
2683598|NCT01374516|Secondary|Number of Symptomatic VCD Cases Meeting World Health Organization (WHO) Criteria Throughout the Trial Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo|Dengue hemorrhagic fever (DHF) cases were defined as number of participants with at least one symptomatic VCD episode meeting the 1997 WHO criteria. (a) Fever: acute onset, high (>= 38°C) and continuous, lasting 2 to 7 days and (b) any of the pre-listed hemorrhagic manifestations and laboratory findings of thrombocytopenia (platelet <=100 x 109/L) and plasma leakage as shown by hemoconcentration (hematocrit increased by 20% or more) or pleural effusion (seen on CXR) and/or ascites and/ or hypoalbuminemia. The first two clinical criteria plus thrombocytopenia and signs of plasma leakage are enough to establish a clinical diagnosis of DHF. DHF was graded as follows: Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test; Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhage.|Day 0 to the end of study (up to 72 months)|Number of WHO dengue hemorrhagic fever cases were assessed in the Safety Analysis Set, which included all participants who received at least one dose of study vaccine. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.|||Cases|||Number
2683599|NCT01374516|Secondary|Number of Symptomatic VCD Cases Due to Any Serotype Post-dose 2 Following Injection With Either CYD Dengue Vaccine or a Placebo|Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature >= 38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue RT-PCR and/or dengue NS 1 ELISA. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Group.|28 days post-injection 2 and up to 13 months post-injection 3|Number of symptomatic VCD cases were assessed in the Other Efficacy Analysis Set, which included participants who received at least 2 doses of study vaccine.|||Cases|||Number
2683600|NCT01374516|Secondary|Number of Symptomatic VCD Cases Due to Any Serotype Occurring 28 Days Post-dose 1 Following Injection With Either CYD Dengue Vaccine or a Placebo|Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature >= 38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue RT-PCR and/or dengue NS 1 ELISA. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Group.|28 days post-injection 1 and up to 13 months post-injection 3|Number of symptomatic VCD cases were assessed in the Full Analysis Set for Efficacy, which included participants who received at least 1 dose of study vaccine.|||Cases|||Number
2683601|NCT01374516|Secondary|Number of Symptomatic VCD Cases Due to Any Serotype During the Active Phase Following Injection With Either CYD Dengue Vaccine or a Placebo|Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature >=38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue RT-PCR and/or dengue NS 1 ELISA. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Group.|Day 0 up to 13 months post-injection 3|Number of symptomatic VCD cases were assessed in the Full Analysis Set for Efficacy, which included all participants who received at least 1 injection.|||Cases|||Number
2683602|NCT01374516|Primary|Number of Symptomatic Virologically Confirmed Dengue (VCD) Cases Due to Any Serotype During the Active Phase Post-dose 3 Following Injection With Either CYD Dengue Vaccine or a Placebo|Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature >=38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue reverse transcriptase polymerase chain reaction (RT-PCR) and/or dengue non-structural (NS) protein 1 antigen enzyme-linked immunosorbent assay (ELISA). Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Group.|28 days and up to 13 months post-injection 3|Number of symptomatic VCD cases were assessed in the Per-Protocol Analysis Set for Efficacy, defined as participants who had no protocol deviations.|||Cases|||Number
2683603|NCT01374451|Secondary|Summary of Pasireotide Concentrations Following Intramuscular Injection of Pasireotide LAR 60mg||Cycle 1 Day 21, Cycle 2 Day 29|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.|||ng/mL||Standard Deviation|Mean
2683604|NCT01374451|Secondary|Summary of Pharmacokinetics (PK) for Everolimus for Tmax||Cycle 2 Day 1|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.|||hr||Inter-Quartile Range|Median
2683605|NCT01374451|Secondary|Summary of Pharmacokinetics (PK) for Everolimus for Cmax and Cmin||Cycle 2 Day 1|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.|||ng/mL||Standard Deviation|Mean
2683606|NCT01374451|Secondary|Summary of Pharmacokinetics (PK) for Everolimus for CL/F||Cycle 2 Day 1|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.|||L/hr||Standard Deviation|Mean
2683607|NCT01374451|Secondary|Summary of Pharmacokinetics (PK) for Everolimus for AUClast||Cycle 2 Day 1|PK analysis set consisted of all patients who had at least 1 pasireotide LAR injection or 1 everolimus administration and 1 evaluable concentration data.|||ng*hr/mL||Standard Deviation|Mean
2683608|NCT01374451|Secondary|Disease Control Rate (DCR) as Per Radiology Review|Disease control rate is the percentage of patients with a best overall response of CR or PR or stable disease (SD) determined by the local radiologist according to the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) Version 1.0. CR: Disappearance of all nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameter of all target lesions recorded at or after baseline. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD). PD: Any progression ≤ 18 weeks after randomization (and not qualifying for CR, PR or stable disease SD.|Once 80 PFS events had occurred|The FAS consisted of all randomized patients.1 patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems. The study was terminated because the study did not meet its primary objective so minimal efficacy data was obtained.|||Percentage of participants||95% Confidence Interval|Number
2683611|NCT01374451|Secondary|Duration of Response (DoR)|80 PFS are expected after approximately 24 months. Kaplan Meier was initially planned to be used to depict duration of response by treatment group and by stratum. Later based on the mode of action of everolimus and pasireotide and based on study experience, only a low number of objective responses per RECIST were expected. Therefore, protocol was amended to only list duration of response, and confirmed responses were flagged in the listing. Hence, statistical analyses were not planned and such data are not available for the following table.|Once 80 PFS events had occurred|The FAS consisted of all randomized patients. Only a low number of objective responses per RECIST was expected. Therefore, protocol was amended to only list duration of response, and confirmed responses were flagged in the listing. Hence, statistical analyses were not planned and such data are not available for the following table.||||||
2683612|NCT01374451|Secondary|Objective Response Rate (ORR) as Per Radiology Review|"Objective response was determined by the local radiologist according to the RECIST Version 1.0. ORR is the percentage of patients with a best overall response of complete response (CR) or partial response (PR). This is also referred to as Overall response rate.~CR: Disappearance of all nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameter of all target lesions recorded at or after baseline."|Once 80 PFS events had occurred|The FAS consisted of all randomized patients.1 patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems. The study was terminated because the study did not meet its primary objective so minimal efficacy data was obtained.|||Percentage of participants||95% Confidence Interval|Number
2683613|NCT01374451|Secondary|Safety and Tolerability Profile of Everolimus Alone or in Combination With Pasireotide LAR|Consisted of monitoring and recording the rate, type, severity, and causal relationship of adverse events (AEs) and serious AEs (SAEs) to treatment. The safety analysis was based mainly on the frequency of AEs or SAEs and on the number of laboratory values that fell outside of pre-determined range.|Once 80 PFS events had occurred|"Safety analysis population included all patients who received any study medication (i.e. at least 1 dose of the study drug in case of monotherapy or at least 1 dose of any 1 compound of the study treatment in case of a combination therapy) with a post-Baseline safety assessment.~See Adverse Events (AE) section for all AEs collected."|||Participants|||Number
2683614|NCT01374451|Primary|Progression-free Survival (PFS) Per Local Radiological Review|PFS per RECIST 1.0. (Response Evaluation Criteria in Solid Tumors). PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause.|Once 80 PFS events had occurred aproximately after 24 months|"The FAS consisted of all randomized patients. Following the intention to treat principle patients were analyzed according to the treatment (and stratum) they were assigned to at randomization.~One patient in the everolimus + pasireotide LAR treatment arm was untreated due to administrative problems."|||months||95% Confidence Interval|Median
2683615|NCT01374438|Secondary|Change From Baseline in HMW Adiponectin of MSDC-0160 or Placebo Over 12 Weeks|Estimate the effect of 150 mg daily MSDC-0160 versus placebo on levels of high molecular weight adiponectin. Increases in HMW adiponectin suggest improved insulin sensitivity.|Days 1(baseline) and 91||||micromol/L||Standard Deviation|Mean
2683616|NCT01374438|Secondary|Change From Baseline in Cognitive Function as Estimate With the Executive Function Scale|Estimate of the effect of 3-months of MSDC-0160 treatment versus placebo on a 9-item executive function scale. A summary measure of executive function was constructed by converting raw scores from 9 individual tests into z-scores as described by Bennett DA, et al., The Rush Memory and Aging Project: study design and baseline characteristics of the study cohort, Neuroepidemiology. 2005;25(4):163-175.|Days 1 (baseline) and 91|One subject in the MSDC-0160 group and 2 subjects in the placebo group were not able to complete the executive function tests at both study time points.|||z-score||Standard Deviation|Mean
2683617|NCT01374438|Secondary|Change From Baseline in Cognitive Function as Determined by the ADAS-Cog Subscale|Alzheimer's Disease Assessment Scale - Cognitive Subscale, an assessment of cognitive ability. Scores on 11 individual tasks were summed to produce the reported total score, with a possible range of 0 (no impairment) to 70 (severe impairment).|Days 1 (baseline) and 91|One subject in the MSDC-0160 group and 2 subjects in the placebo group were not able to complete the ADAS-Cog tests at both study time points.|||Scores on a scale||Standard Deviation|Mean
2683618|NCT01374438|Secondary|Change From Baseline in Global Cognitive Function Tests|Change from baseline in cognitive function, as determined by global cognitive function on a neuropsychological battery of 19 tests, following 3 months treatment with MSDC-0160 versus placebo. A summary measure of global cognitive function was constructed by converting raw scores from 19 individual tests into z-scores as described by Bennett DA, et al., The Rush Memory and Aging Project: study design and baseline characteristics of the study cohort, Neuroepidemiology. 2005;25(4):163-175.|Days 1 (baseline) and 91||||z-scores||Standard Deviation|Mean
2683619|NCT01374438|Primary|Effects of MSDC-0160 on Cerebral Metabolic Glucose Rate or Placebo Over 12 Weeks in Pre-specified Regions of Interest Analysis Referenced to Cerebellum|Investigate the effect of 150 mg daily MSDC-0160 vs placebo on 3-month change in brain glucose utilization using FDG-PET pre-specified regions of interest analysis referenced to cerebellum, including five bilateral regions: posterior cingulate, parietal cortex (angular gyrus), lateral temporal cortex, medial temporal cortex, and anterior cingulate-medial frontal cortex. Results are reported as Standardized Uptake Value Ratios. A change from baseline in the metabolic rate of glucose that is ≥0 indicates maintenance of brain glucose utilization, whereas values <0 indicate a decline in brain glucose utilization.|Days 1(baseline) and 91|Intent-to-treat|||Ratio||Standard Deviation|Mean
2683620|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
2683621|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
2683622|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
2683623|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With Wild-Type KRAS Versus Participants With Mutant KRAS|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
2683624|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
2683625|NCT01374425|Secondary|OS in Participants With Wild-Type KRAS Versus Participants With Mutant KRAS|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
2683626|NCT01374425|Secondary|OS in Participants With High VEGF-A Levels Versus Participants With Low VEGF-A Levels|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
2683627|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With Wild-Type V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Versus Participants With Mutant KRAS|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
2683828|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 28|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 28 measurement.|Day 28|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.|||participants|||Number
2683628|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
2683629|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
2683630|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection in Participants With Low ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
2683631|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection in Participants With Low ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
2683632|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection in Participants With High ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
2683633|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection in Participants With High ERCC-1 Levels|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|"ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
2683634|NCT01374425|Secondary|Percentage of Participants With Complete Liver Metastasis Resection|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. The percentage of participants with R0 resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2684758|NCT01364584|Secondary|Change From Baseline in Peak Dilation of Brachial Artery Diameter|Change in the response of the brachial artery to hyperemia will be assessed before and after 3 months of study medication or placebo.|Baseline and 3 months||||millimeters||Standard Deviation|Mean
2683635|NCT01374425|Secondary|Percentage of Participants With Liver Metastasis Resection|The timing of resective surgery was not defined in the protocol and was left at the discretion of the Investigator. Resection was classified as R0, R1, or R2 following surgery. R0 was defined as complete resection with clear margins ≥1 mm. R1 was defined as the presence of exposed tumor or histologically detected tumor cells at the line of transection, or <1 mm microscopic margins. In the case of use of radiofrequency ablation or cryotherapy, the resection was considered as R1. R2 was defined as macroscopic positive margins or incomplete resection at time of surgery. The percentage of participants with resection of liver or liver plus lymph node metastases was reported. The 95% CI was computed using normal approximation to the binomial distribution.|At time of resective surgery during study (maximum up to 45 months overall)|ITT Population; only those participants with liver or liver plus lymph node metastases were included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2683636|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
2683637|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels|Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
2683638|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1 in Participants With High ERCC-1 Levels|Disease control was defined as CR, PR, or SD according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
2683639|NCT01374425|Secondary|Percentage of Participants With Disease Control According to RECIST Version 1.1|Disease control was defined as CR, PR, or stable disease (SD) according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. SD was defined as neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for disease progression (≥20% increase in sum of LD of target lesions plus absolute increase ≥5 mm) in reference to the smallest sum of LD on study. The percentage of participants with CR, PR, or SD was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|ITT Population|||percentage of participants||95% Confidence Interval|Number
2683640|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
2683641|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
2683642|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1 in Participants With High ERCC-1 Levels|Objective response was defined as CR or PR according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||percentage of participants||95% Confidence Interval|Number
2683643|NCT01374425|Secondary|Percentage of Participants With Objective Response According to RECIST Version 1.1|Objective response was defined as complete response (CR) or partial response (PR) according to RECIST Version 1.1. CR was defined as disappearance of all target lesions and short-axis reduction to less than (<) 10 mm of any pathological lymph nodes. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to sum of LD at Baseline. Confirmation of response at a consecutive assessment was not required. The percentage of participants with CR or PR was reported. The 95% CI was computed using normal approximation to the binomial distribution.|From Baseline until disease progression; assessed every 6 weeks (maximum up to 45 months overall)|ITT Population|||percentage of participants||95% Confidence Interval|Number
2683644|NCT01374425|Secondary|OS in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
2683645|NCT01374425|Secondary|OS in Participants With Low ERCC-1 Levels|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
2683646|NCT01374425|Secondary|OS in Participants With High ERCC-1 Levels|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
2683647|NCT01374425|Secondary|Overall Survival (OS)|Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. OS was defined as the time from randomization to death. The median duration of OS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death (maximum up to 45 months overall)|ITT Population|||months||95% Confidence Interval|Median
2683648|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and Low VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
2683649|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 and High VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
2683672|NCT01374269|Secondary|Quality of Life, Vitality.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
2683650|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and Low VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
2683651|NCT01374425|Secondary|PFS According to RECIST Version 1.1 in Participants With High ERCC-1 and High VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
2683652|NCT01374425|Primary|PFS According to RECIST Version 1.1 in Participants With High Vascular Endothelial Growth Factor (VEGF)-A Levels Versus Participants With Low VEGF-A Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
2683653|NCT01374425|Primary|PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels Versus Participants With Low ERCC-1 Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
2683654|NCT01374425|Primary|PFS According to RECIST Version 1.1 in Participants With Low ERCC-1 Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
2683655|NCT01374425|Primary|PFS According to RECIST Version 1.1 in Participants With High ERCC-1 Levels|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as ≥20% increase in sum of LD of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 mm. Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% CI was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|"ITT Population. The Number of Participants Analyzed reflects the number of evaluable participants for the outcome measure."|||months||95% Confidence Interval|Median
2683829|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 21|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 21 measurement.|Day 21|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.|||participants|||Number
2683656|NCT01374425|Primary|Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1|Tumor assessments were performed according to RECIST Version 1.1. Disease progression was defined as greater than or equal to (≥) 20 percent (%) increase in sum of largest diameters (LD) of target lesions in reference to the smallest sum of LD on study, in addition to an absolute increase ≥5 millimeters (mm). Disease progression was further defined as the last documented progression determined by the Investigator no later than 1 day before initiation of second-line therapy. Death on study included death from any cause occurring no later than 3 months after the last component of study treatment. PFS was defined as the time from randomization to death or disease progression, whichever occurred first. The median duration of PFS was estimated by Kaplan-Meier analysis and expressed in months. The 95% confidence interval (CI) was computed using the method of Brookmeyer and Crowley.|From Baseline until death or disease progression; assessed every 6 weeks (maximum up to 45 months overall)|Intent-to-treat (ITT) Population|||months||95% Confidence Interval|Median
2683657|NCT01374269|Secondary|Medical Consultations.|This result shows, the total number of participants received additional medical consultations.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||participants|||Number
2683658|NCT01374269|Secondary|Medical Consultations.|This result shows, the total number of participants received additional medical consultations.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||participants|||Number
2683659|NCT01374269|Secondary|Medical Consultations.|This result shows, the total number of participants received additional medical consultations.|4 weeks||||participants|||Number
2683660|NCT01374269|Secondary|Missing Workdays|This result shows the average of the number of missed work days.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||Days||Standard Deviation|Mean
2683661|NCT01374269|Secondary|Missing Workdays|This result shows the average of the number of missed work days.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||Days||Standard Deviation|Mean
2683662|NCT01374269|Secondary|Missing Workdays|This result shows the average of the number of missed work days.|4 weeks||||Days||Standard Deviation|Mean
2683663|NCT01374269|Secondary|Missing Workdays|This result shows the average of the number of missed work days.|6 weeks before starting||||Days||Standard Deviation|Mean
2683664|NCT01374269|Secondary|Treatments Associated With Low Back Pain at 6 Months|we are showing in this result, the number of patients who had to receive any additional treatment in either group. The measure is the number of participants who received additional treatment throughout the duration of the study.|6 months||||participants|||Number
2683665|NCT01374269|Secondary|Relapses of Lumbar Pain|The percentage of patients with relapsed of low back pain was measured.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||percentage of participants|||Number
2683666|NCT01374269|Secondary|Relapses of Lumbar Pain|The percentage of patients with relapsed of low back pain was measured.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||percentage of participants|||Number
2683667|NCT01374269|Secondary|PHQ-9 Patient Health Questionnaire (PHQ-9) Depression|Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
2683668|NCT01374269|Secondary|PHQ-9 Patient Health Questionnaire (PHQ-9) Depression|Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
2683669|NCT01374269|Secondary|PHQ-9 Patient Health Questionnaire (PHQ-9) Depression|Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).|At the beginning||||units on a scale||Standard Deviation|Mean
2683670|NCT01374269|Secondary|PHQ-9 Patient Health Questionnaire (PHQ-9) Depression|Depression was measured with the Patient Health Questionnaire (PHQ-9), which ranged from 0 (no depression) to 27 (severe depression).|4 weeks||||units on a scale||Standard Deviation|Mean
2683671|NCT01374269|Secondary|Quality of Life, Vitality.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
2696844|NCT01265875|Primary|Opiate Use at Baseline, Days 4 and 30.|Daily opiate use (oral morphine equivalent).|Baseline, Day 4, Day 30.||||mg/day||Standard Deviation|Mean
2683673|NCT01374269|Secondary|Quality of Life, Vitality.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.|4 weeks||||units on a scale||Standard Deviation|Mean
2683674|NCT01374269|Secondary|Quality of Life, Vitality.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Vitality.|At the beginning||||units on a scale||Standard Deviation|Mean
2683675|NCT01374269|Secondary|Quality of Life, Mental Health.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
2683676|NCT01374269|Secondary|Quality of Life, Mental Health.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
2683677|NCT01374269|Secondary|Quality of Life, Mental Health.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.|4 weeks||||units on a scale||Standard Deviation|Mean
2683678|NCT01374269|Secondary|Quality of Life, Mental Health.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Mental Health.|At the beginning||||units on a scale||Standard Deviation|Mean
2683679|NCT01374269|Secondary|Quality of Life, General Health Perceptions.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
2683680|NCT01374269|Secondary|Quality of Life, General Health Perceptions.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
2684800|NCT01363999|Secondary|Plasma Concentration of Atorvastatin Metabolites|Measuring the amount of byproducts of the metabolization of Atorvastatin in the blood plasma.|3 days||||ng/ml||Geometric Coefficient of Variation|Geometric Mean
2683681|NCT01374269|Secondary|Quality of Life, General Health Perceptions.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.|4 weeks||||units on a scale||Standard Deviation|Mean
2683682|NCT01374269|Secondary|Quality of Life, General Health Perceptions.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: General Health Perceptions.|At the beginning||||units on a scale||Standard Deviation|Mean
2683683|NCT01374269|Secondary|Quality of Life, Social Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
2683684|NCT01374269|Secondary|Quality of Life, Social Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
2683685|NCT01374269|Secondary|Quality of Life, Social Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.|4 weeks||||units on a scale||Standard Deviation|Mean
2683686|NCT01374269|Secondary|Quality of Life, Social Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Social Function.|At the beginning||||units on a scale||Standard Deviation|Mean
2683687|NCT01374269|Secondary|Quality of Life, Physical Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
2683688|NCT01374269|Secondary|Quality of Life, Physical Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
2684801|NCT01363999|Primary|Plasma Concentration of Atorvastatin||3 days||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2684802|NCT01363999|Primary|Plasma Concentration of Dalcetrapib Active Form||3 days||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2683689|NCT01374269|Secondary|Quality of Life, Physical Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.|4 weeks||||units on a scale||Standard Deviation|Mean
2683690|NCT01374269|Secondary|Quality of Life, Physical Function.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Function.|At the beginning||||units on a scale||Standard Deviation|Mean
2683691|NCT01374269|Secondary|Quality of Life, Physical Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
2683692|NCT01374269|Secondary|Quality of Life, Physical Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
2683693|NCT01374269|Secondary|Quality of Life, Physical Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance|4 weeks||||units on a scale||Standard Deviation|Mean
2683694|NCT01374269|Secondary|Quality of Life, Physical Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Physical Performance|At the beginning||||units on a scale||Standard Deviation|Mean
2683695|NCT01374269|Secondary|Quality of Life, Emotional Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
2683696|NCT01374269|Secondary|Quality of Life, Emotional Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
2685195|NCT01361633|Secondary|Tower of London|Assesses executive functioning|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up|||||||
2683697|NCT01374269|Secondary|Quality of Life, Emotional Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.|4 weeks||||units on a scale||Standard Deviation|Mean
2683698|NCT01374269|Secondary|Quality of Life, Emotional Performance.|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: Emotional Performance.|At the beginning||||units on a scale||Standard Deviation|Mean
2683699|NCT01374269|Secondary|Quality of Life, Bodily Pain|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
2683700|NCT01374269|Secondary|Quality of Life, Bodily Pain|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
2683701|NCT01374269|Secondary|Quality of Life, Bodily Pain|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.|4 weeks||||units on a scale||Standard Deviation|Mean
2683702|NCT01374269|Secondary|Quality of Life, Bodily Pain|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: bodily pain.|At the beginning||||units on a scale||Standard Deviation|Mean
2683703|NCT01374269|Secondary|Quality of Life, Change in Health|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
2683704|NCT01374269|Secondary|Quality of Life, Change in Health|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
2685020|NCT01362491|Secondary|Duration of Relief|Median participant time for dropping out of the study due to lack of efficacy or receipt of rescue medication, whichever came first.|0 to 3 hours|Population included all randomized patients that reported a treatment failure or received rescue medication.||||||
2683705|NCT01374269|Secondary|Quality of Life, Change in Health|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.|4 weeks||||units on a scale||Standard Deviation|Mean
2683706|NCT01374269|Primary|Visual Analogue Scale of Pain|The best result is 0 and the worst is 100, Pain relief more than 25 mm on the Visual Analogue Scale, assessed 24 weeks after intervention.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
2683707|NCT01374269|Primary|Visual Analogue Scale of Pain|In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at 12 weeks.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
2683708|NCT01374269|Primary|Visual Analogue Scale of Pain|In the VAS the best result is 0 and the worst is 100. The primary outcome was pain improvement of ≥25 mm on the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at 4 weeks.|4 weeks||||units on a scale||Standard Deviation|Mean
2683709|NCT01374269|Secondary|Quality of Life, Change in Health|Improvement in Quality of life was assessed with the SF-36 questionnaire, which ranges from 0 to 100 being 100 the best quality of life. The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. This outcome shows the subdomain data: change in health.|At the beginning||||units on a scale||Standard Deviation|Mean
2683710|NCT01374269|Secondary|Roland-Morris Questionnaire|Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
2683711|NCT01374269|Secondary|Roland-Morris Questionnaire|Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
2683712|NCT01374269|Secondary|Roland-Morris Questionnaire|Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.|4 weeks||||units on a scale||Standard Deviation|Mean
2683713|NCT01374269|Secondary|Roland-Morris Questionnaire|Improvement in function assessed by the Roland-Morris questionnaire, a widely used health status measure for low back pain. The RMDQ can be used in research or clinical practice. Scoring the RMDQ. The RMDQ is scored by adding up the number of items checked by the patient. The score can therefore vary from 0 to 24. It is not recommended to give patients a 'Yes' / 'No' option. If patients indicate in any way that an item is not applicable to them, the item is scored 'No', i.e. the denominator remains 24. Being worst 24.|At the beginning||||units on a scale||Standard Deviation|Mean
2683714|NCT01374269|Secondary|Oswestry Disability Index|Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.|24 weeks|We lost 2 patients in arm exercise 1 because we ran out of time limit for the investigation and could not evaluate them and 1 who did not answer our calls . In the NSAIDs arm we recover 3 patients who did not answer the call for three months evaluation, and lost 4 for deadline of the investigation.|||units on a scale||Standard Deviation|Mean
2683744|NCT01373671|Primary|Efficacy Based on the Area Under the Receiver Operating Characteristic (ROC) Curve in Breasts Analyzed With DBT as an Adjunct to FFDM vs. FFDM Alone|The primary objective of this study was to demonstrate the superiority of DBT and FFDM images together in comparison to FFDM images alone with respect to the ability of readers to detect and diagnose malignant lesions. A comparison of the breast-level ROC areas was used to evaluate the superiority of DBT as an adjunct to FFDM vs. FFDM alone.|1 year|Per protocol 300 subjects were selected for analysis based on 89% power & 5% type one error rate determination.|||unitless|breasts|Standard Error|Mean
2683715|NCT01374269|Secondary|Oswestry Disability Index|Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.|12 weeks|We lost 4 patients in arm exercise because we ran out of time limit for the investigation and could not evaluate them. And we lost 4 in arm NSAIDs, 3 who did not answer our calls and 1 for close investigation.|||units on a scale||Standard Deviation|Mean
2683716|NCT01374269|Secondary|Oswestry Disability Index|Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.|4 weeks||||units on a scale||Standard Deviation|Mean
2683717|NCT01374269|Secondary|Oswestry Disability Index|Function was assessed using the Oswestry Disability Index questionnaire Version 2.1a, which ranges from 0 to 100 (greater disability), being worst 100. The Oswestry Disability Index is currently considered by many as the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. 0% to 20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.|At the beginning||||units on a scale||Standard Deviation|Mean
2683718|NCT01374269|Primary|Visual Analogue Scale of Pain|In the Visual Analogue Sacale the best result is 0 and the worst is 100, The primary outcome was pain the mesurement of the Visual Analog Scale (VAS) (0 [no pain] to 100 [maximum pain]) at the beginning.|At the beginning||||units on a scale||Standard Deviation|Mean
2683719|NCT01374217|Secondary|Effect of PDE5 Inhibition on Immune Function as Assessed by MDSC Quantification|Percentage change in the amount of myeloid derived suppressor cells (MDSCs) in peripheral blood.|Up to 6 months|Data was not collected to assess this outcome measure.||||||
2683720|NCT01374217|Secondary|Quality of Life Scores|Median change in symptom scores. Scale is the EORTC QLQ-C30. There are three domains: symptom scale (score range 7-14); past week (score range 21-82); and global health status (score range 2-14). Higher or increasing scores mean worse outcomes; lower or decreasing scores mean better outcomes.|3 months (M3) and 6 months (M6)|Two participants returned the Month 3 survey and seven participants returned the Month 6 survey (there is some overlap). The remaining participants cannot be analyzed as there is no follow-up data.|||change in score on a scale||Full Range|Median
2683721|NCT01374217|Secondary|Time to Progression|Median time to progression of disease in days.|Up to 71 days|One participant was not analyzed because he only received eight days of study drug prior to progression and removal from study. One participant was retrospectively ineligible and was therefore not analyzed.|||days||95% Confidence Interval|Median
2683722|NCT01374217|Secondary|Duration of Response|Median length of response in months.|Up to 6 months|This analysis only includes the 5 participants who had a clinical response.|||months||Full Range|Median
2683723|NCT01374217|Primary|Response Rate|Percentage of participants who responded to the addition of tadalafil. Response is defined as a complete remission (CR), very good partial remission (VGPR), partial remission (PR), or stable disease (SD) by International Uniform Response criteria.|Up to 6 months|One participant was not analyzed because he only received eight days of study drug prior to progression and removal from study. One participant was retrospectively ineligible and was therefore not analyzed.|||Participants|||Count of Participants
2683724|NCT01374178|Secondary|Number of Participants With Clinically Significant Effects|Clinically significant effects were defined as serious and nonserious adverse events. A summary of serious and all other nonserious adverse events is located in the Reported Adverse Event module.|Baseline up to 30 days|All randomized participants were included in the analysis.|||participants|||Number
2683725|NCT01374178|Secondary|Time of Maximum Glucose Infusion Rate (tRmax)||Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable glucodynamic data.|||hour (h)||Full Range|Median
2683726|NCT01374178|Secondary|Total Glucose Infused (Gtot)||Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable glucodynamic data were included in the analysis.|||gram (g)||Geometric Coefficient of Variation|Geometric Mean
2683727|NCT01374178|Secondary|Maximum Glucose Infusion Rate (Rmax)||Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable glucodynamic data were included in the analysis.|||grams per hour (g/h)||Geometric Coefficient of Variation|Geometric Mean
2683728|NCT01374178|Secondary|Pharmacokinetics: Maximum Concentration (Cmax)||Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable pharmacokinetic data were included in the analysis.|||picomole per liter (pmol/L)||Geometric Coefficient of Variation|Geometric Mean
2683729|NCT01374178|Primary|Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)|AUC from time zero to 24 hours (AUC0-24) is reported for this outcome measure.|Periods 1 and 2: Baseline up to 24 hours|All randomized participants who received at least 1 dose of study drug, completed at least 1 clamp procedure, and had evaluable pharmacokinetic data were included in the analysis.|||picomole*hour per liter (pmol*hr/L)||Geometric Coefficient of Variation|Geometric Mean
2683745|NCT01373580|Secondary|Number of Participants With Induced Manifest Refractive Astigmatism in the Implanted Eye|Less than 5% of participants should have postoperative manifest refractive astigmatism in the implanted eye that increases from baseline by greater than 2.00 D at 6 months postoperative and all subsequent visits.|At 6 months postoperative and all subsequent visits|Numbers analyzed at each timepoint differ due to participant availability.|||Count of Participants|||Number
2689509|NCT01326845|Secondary|Difference in Frequency of Specific Commonly Reported GI AEs Between the Two Treatment Groups|Study was prematurely terminated and not powered for efficacy.|months 3 and 6.|||||||
2683730|NCT01374087|Secondary|Change in Quality of Life (QoL) Modifications (Spanish Version of the Expanded Prostate Cancer Index Composite (EPIC) Questionnaire) From Baseline at 5 Years|EPIC assessed the disease-specific aspects of prostate cancer and its therapies and comprised four summary domains (Urinary, Bowel, Sexual and Hormonal). Factor analysis supported dividing the Urinary Domain Summary Score into two different Incontinence and Irritative/Obstructive subscales. In addition, each Domain Summary Score had measurable Function Subscale and Bother Subscale components. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.|Baseline and 5 years.|No data analyses for change from baseline score for QoL modifications were conducted as the study was terminated prior to completion of the 5 year follow-up.||||||
2683731|NCT01374087|Secondary|Number of Participants With Change in Total Serum PSA Levels From Baseline at 3, 6 and 12 Months|"Blood samples were drawn for serum PSA at baseline (Visit 1) and at 3, 6 and 12 months.~Changes from baseline in total serum PSA levels in relation to the normal parameter ranges are indicated. WNR = Within Normal Range, BNR= Below Normal Range and ANR = Above Normal Range."|Baseline and 3, 6 and 12 months|The Safety population consisted of all randomised subjects who received at least one dose of study medication. Only subjects with data available at each timepoint are included.|||Participants|||Count of Participants
2683732|NCT01374087|Secondary|Number of Participants With Change in Total Serum Testosterone Levels From Baseline at 3, 6 and 12 Months|"Blood samples were drawn for serum testosterone at baseline (Visit 1) and then at 3, 6 and 12 months.~Changes from baseline in total serum testosterone levels in relation to the normal parameter ranges are indicated. WNR = Within Normal Range, BNR= Below Normal Range and ANR = Above Normal Range."|Baseline and 3, 6 and 12 months|The Safety population consisted of all randomised subjects who received at least one dose of study medication. Only subjects with data available at each timepoint are included.|||Participants|||Count of Participants
2683733|NCT01374087|Secondary|Overall Survival|Overall survival was defined as the time in months from diagnosis (biopsy date for local recurrence) to death due to any cause, the last visit or the loss to follow-up.|5 years|No data analyses for Overall Survival were conducted as the study was terminated prior to completion of the 5 year follow-up.||||||
2683734|NCT01374087|Secondary|BFFS Percentage 5 Years From Treatment Initiation|A subject had a biochemical failure if there was an increase of PSA of 2 ng/mL or more in comparison with the pre-study nadir PSA confirmed in the course of follow-up by a second value after 3 or more weeks or with diagnosis of a new clinical recurrence of their prostate cancer over the 5 year follow-up.|5 years|No data analyses were conducted as the study was terminated prior to completion of the 5-year follow-up.||||||
2683735|NCT01374087|Secondary|Time to Progression|"Time to progression (in months) was measured from the informed consent date to the date of first event occurrence. Progression was defined as either: death from all causes or disease progression (defined as PSA increased by 2 ng/mL as compared to the pre-trial nadir PSA, confirmed during follow-up by a second value after 3 or more weeks, or the diagnosis of a new clinical recurrence of their prostate cancer (metastasis, new injury, etc.)).~As the study was prematurely terminated, no analyses were conducted. Data for time to progression are listed by subject for those individuals who reported progression."|Up to 5 years|A total of 3 subjects in the brachytherapy group and 4 subjects in the brachytherapy + triptorelin 22.5 mg group reported treatment failure. The subject numbers assigned in the study are not presented. The subjects with progression are listed as Subjects 1 to 7, with these bearing no relation to the subject numbers used for other endpoints herein.|||Months|||Number
2683736|NCT01374087|Primary|Biochemical Failure-free Survival (BFFS)|"BFFS was determined by a prostate-specific antigen (PSA) increase of 2 nanograms per millilitre (ng/mL) or more in comparison with the pre-study nadir PSA and confirmed in the course of follow-up by a second value 3 weeks later or longer over the 5 year follow-up. Time to BFFS was defined from treatment initiation to the first time when PSA increase of 2 ng/mL was observed.~As the study was prematurely terminated, no analyses were conducted. Data for BFFS are listed by subject for those individuals who reported biochemical failure. Time (in months) to biochemical failure is relative to the date of brachytherapy."|Up to 5 years|A total of 3 subjects in each treatment group reported biochemical failure. The subject numbers assigned in the study are not presented. The subjects with biochemical failure are listed as Subject 1 to Subject 6, with these bearing no relation to the subject numbers used for other endpoints herein.|||Months|||Number
2683737|NCT01373931|Primary|Area Under the Concentration-Time Curve Over a Dosing Interval (AUCτ) of Ethinyl Estradiol and Norelgestromin|The results presented are Geometric Least Squares (LS) mean. LS mean values were adjusted for treatment, sequence, period and participant.|Predose up to 24 hours post dose on Day 21|All randomized participants who received at least 1 dose of study drug and had pharmacokinetics data to analyze AUCτ. Participants were analyzed based on the treatment they received.|||picograms*hour/milliliter (pg*hr/mL)||90% Confidence Interval|Geometric Mean
2683738|NCT01373931|Primary|Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of Ethinyl Estradiol and Norelgestromin||Predose up to 24 hours post dose on Day 21|All randomized participants who received at least 1 dose of study drug and had pharmacokinetics data to analyze tmax. Participants were analyzed based on the treatment they received.|||hour (h)||Full Range|Median
2683739|NCT01373931|Primary|Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Ethinyl Estradiol and Norelgestromin|The results presented are Geometric Least Squares (LS) mean. LS mean values were adjusted for treatment, sequence, period and participant.|Predose up to 24 hours post dose on Day 21|All randomized participants who received at least 1 dose of study drug and had pharmacokinetics data to analyze Cmax. Participants were analyzed based on the treatment they received.|||picograms/milliliter (pg/mL)||90% Confidence Interval|Geometric Mean
2683740|NCT01373918|Secondary|Anthropometric Measurements|Growth will be assessed by weight at the time of hospital discharge (approximately 5 weeks)|approximately 5 weeks||||g||Standard Deviation|Mean
2683741|NCT01373918|Secondary|Anthropometric Measurements|Growth will be assessed by growth velocity at 28 days of age|28 days of age||||g/d||Standard Deviation|Mean
2683742|NCT01373918|Secondary|Mortality Rate|death|at the end of the hospital stay which is expected to be an average of 5 weeks||||participants|||Number
2683743|NCT01373918|Primary|Presence of Cholestasis|Cholestasis will be defined by a direct bilirubin > 2 mg/dL|prior to 100 days of life, hospital discharge, or death whichever comes first||||participants|||Number
2683746|NCT01373580|Secondary|Number of Participants With no or Minimal Loss of Best Corrected Visual Acuity in the Implanted Eye|Less than 5% of participants should lose more than two lines of best corrected distance and near visual acuity in the implanted eye; and less than 1% of participants with preoperative best spectacle corrected visual acuity (BCDVA) of 20/20 in the implanted eye should have best corrected distance and near visual acuity worse than 20/40 in the implanted eye at 6 months postoperative and all subsequent visits.|at 6 months postoperative and all subsequent visits|Numbers analyzed at each timepoint differ due to participant availability|||Count of Participants|||Number
2683747|NCT01373580|Primary|Number of Participants With Improvement in Uncorrected Near Visual Acuity (20/40 or Better) in the Implanted Eye|75% of participants should achieve uncorrected near visual acuity in the implanted eye of 20/40 or better as compared to preoperative baseline|24 Months||||Count of Participants|||Number
2683748|NCT01373489|Primary|Hemoglobin A1c (HbA1c) at 6 Months Post Randomization|Hemoglobin A1c (HbA1c) was measured at 6 months post randomization|6 months post randomization|Final analysis used baseline A1c analysis of covariance for differences in levels of A1c at 6 months between the treatment groups with baseline A1c as covariate.|||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2683749|NCT01373450|Secondary|Change From Baseline in Insulinotrophic Effect (ISR/G) After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM|Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose (G), insulin and C-peptide levels were measured from blood collected at baseline and during GGI; with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR) and hence determine ISR/G.|Baseline and up to 160 minutes after start of GGI|All treated participants. Six participants were treated for two periods with placebo, resulting in placebo n = 18.|||ISR (ng/min) / Glucose (mg/dL)||Standard Deviation|Least Squares Mean
2683750|NCT01373450|Secondary|Change From Baseline in Gmax After Single Doses of 0.6 mg Lg, or 1.2 mg Lg, Compared With Single Doses of Placebo or OXM|Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI to determine the maximum ambient glucose concentration above baseline.|Baseline and up to 160 minutes after start of GGI|All treated participants. Six participants were treated for two periods with placebo, resulting in a placebo n = 18.|||mg/dL||Standard Deviation|Least Squares Mean
2683751|NCT01373450|Secondary|Change From Baseline in Insulinotrophic Effect (ISR/G) at the Highest Glucose Infusion Rate After Two Periods of Placebo Treatment|The reproducibility of insulinotrophic effects was compared after two separate placebo treatment periods within the same treatment sequence. Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single subcutaneous dose of placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Over these two treatment periods glucose (G), insulin and C-peptide levels were measured from blood collected at the highest glucose infusion rate; with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR), and hence to determine the insulinotrophic effect, ISR/G.|Baseline and 160 minutes after start of GGI at each placebo treatment period|Participants within the same treatment sequence who were treated with Placebo in two separate treatment periods. Participants treated with Oxyntomodulin or Liraglutide were not analyzed for this outcome measure.|||ISR (ng/mg) / Glucose (mg/dL)||Standard Deviation|Mean
2683752|NCT01373450|Primary|Change From Baseline in Beta Cell Sensitivity to Glucose (Φ) After a Single Dose of OXM|Beta cell sensitivity measures the ability to mount an insulin secretory response relative to the level of ambient plasma glucose. Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting 40 minutes. Glucose (G), insulin and C-peptide levels were measured from blood collected at baseline and during GGI, with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR). Beta Cell Sensitivity (Φ) was determined from the regression of the ISR on ambient plasma glucose (G).|Baseline and up to160 minutes after start of GGI|Participants treated with Oxyntomodulin or placebo. Six participants were treated for two periods with placebo, resulting in placebo n = 18. Participants treated with Liraglutide were not analyzed for this outcome measure.|||ISR (ng/mL) / Glucose (mg/dL)||Standard Deviation|Least Squares Mean
2683753|NCT01373450|Primary|Change From Baseline in Maximum Ambient Glucose Concentration (Gmax) After a Single Dose of OXM|Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI to determine the maximum ambient glucose concentration above baseline.|Baseline and up to 160 minutes after start of GGI|Participants treated with Oxyntomodulin or placebo. Six participants were treated for two periods with placebo, resulting in placebo n = 18. Participants treated with Liraglutide were not analyzed for this outcome measure.|||mg/dL||Standard Deviation|Least Squares Mean
2683754|NCT01373450|Primary|Change From Baseline in Time-weighted Average of Glucose Measured by Area Under the Curve (AUC) After a Single Dose of Oxyntomodulin (OXM)|Participants received on Day (-1) an overnight intravenous (IV) infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of liraglutide (Lg) or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 OXM or placebo for OXM, accompanied by up to 160 minutes of graded glucose infusion (GGI). During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI at the following minutes: 0, 20, 40, 60, 80, 100, 120, 140, 160 and 165 in order to calculate the time-weighted average change from baseline in glucose AUC from 0-160 minutes.|Baseline and during GGI at time points 0, 20, 40, 60, 80, 100, 120, 140, 160 and 165 minutes|Participants treated with Oxyntomodulin or placebo. Six participants were treated for two periods with placebo, resulting in placebo n = 18. Participants treated with Liraglutide were not analyzed for this outcome measure.|||mg/dL||Standard Deviation|Least Squares Mean
2683755|NCT01373346|Secondary|Albumin : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of albumin level after operation in good response group for the evaluation of long-term safety."|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We analyzed the change of albumin level after operation for the evaluation of long-term safety in good responder group.|||g/dl||Standard Deviation|Mean
2683756|NCT01373346|Secondary|Hemoglobin : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition in good response group."|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We analyzed the change of hemoglobin after operation in good responder group for the evaluation of long-term safety.|||g/dl||Standard Deviation|Mean
2683757|NCT01373346|Secondary|HbA1c : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of HbA1c after operation in good response group.~HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC)~The HbA1c was calculated as a ratio to total hemoglobin."|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of HbA1c after operation in good responder group."|||percentage of glycated hemoglobin||Standard Deviation|Mean
2683758|NCT01373346|Secondary|Body Mass Index : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of weight change after operation in good response group.~BMI(Body Mass index , kg/㎡) was measured.~BMI was obtained using the following formula:~Weight (kg) / (Height (m) x Height (m))"|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of weight after operation in good responder group."|||kg/㎡||Standard Deviation|Mean
2683759|NCT01373346|Secondary|HOMA-B : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of beta-cell function after operation in good response group. HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured.~HOMA-B was obtained using the following formula:~225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)"|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of beta cell function after operation in good responder group."|||percentage of beta cell function||Standard Deviation|Mean
2683760|NCT01373346|Secondary|HOMA-IR : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of insulin resistance after operation in good response group.~HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured.~HOMA-IR was obtained using the following formula:~Glucose(mg/dl) x Insulin/405"|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of HOMA-IR after operation in good responder group."|||units on a scale||Standard Deviation|Mean
2683830|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 14|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 14 measurement.|Day 14|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed for each time point decreased over the course of the study as participants were discharged from the hospital.|||participants|||Number
2683761|NCT01373346|Secondary|QUICKI : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications. We called this group as good response group. We analyzed the change of insulin sensitivity after operation in good response group. The quantitative insulin sensitivity check index (QUICKI) was measured.~The QUICKI is obtained using the following formula:~1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))"|Before operation, 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of QUICKI after operation in good responder group."|||units on a scale||Standard Deviation|Mean
2683762|NCT01373346|Secondary|Matsuda Index : Good Response Group|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 - 21.7 months). Some patients showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation. We called this group as good response group. We analyzed the change of insulin sensitivity after operation in good response group.~The Matsuda index(Insulin Sensitivity Index) was obtained using the following formula:~Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)]"|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|"At the end of the study, the follow-up duration was 12.5 ± 5.5 months (6.0 – 21.7 months). Normal FPG level and HbA1c < 6% without any antidiabetic medications were observed in 11 patients (78.6 %). We called this group as good responder group. We analyzed the change of insulin sensitivity after operation in good responder group."|||units on a scale||Standard Deviation|Mean
2683763|NCT01373346|Primary|Operation Related Mortality|Operation related mortality was measured for the evaluation of safety for the operation. Operation related mortality was defined as any complication resulting in the death of the patient within 1 month or during hospitalization after operation.|Until end of study (on average 14.8 months)|All of enrolled patient were included.(N=15)|||participants|||Number
2683764|NCT01373346|Primary|Albumin|For the evaluation of long-term safety, albumin was measured to determine malnutrition.|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the long-term safety evaluation.|||g/dl||Standard Deviation|Mean
2683765|NCT01373346|Primary|Hemoglobin|For the evaluation of long-term safety, hemoglobin was measured to determine the degree of anemia and malnutrition.|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the long-term safety evaluation.|||g/dl||Standard Deviation|Mean
2683766|NCT01373346|Primary|HbA1c|"For the evaluation of efficacy for the operation, HbA1c(%) was measured serially (preop. 6months after op. until end of study(on average 14.8 months)).~HbA1c is formed in a non-enzymatic glycation pathway by hemoglobin's exposure to plasma glucose and measured by high-performance liquid chromatography (HPLC) The HbA1c was calculated as a ratio to total hemoglobin."|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.|||percentage of glycated hemoglobin||Standard Deviation|Mean
2683767|NCT01373346|Secondary|Body Mass Index|"BMI(Body Mass index , kg/㎡) was measured.~BMI was obtained using the following formula:~Weight (kg) / (Height (m) x Height (m))"|Before operation, 6 Months After Operation, Until End of Study(on Average 14.8 Months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.|||kg/㎡||Standard Deviation|Mean
2683768|NCT01373346|Secondary|HOMA-B|"HOMA-B(Homoeostasis model assessment-derived beta-cell function) was measured.~HOMA-B was obtained using the following formula:~225 × 18/fasting insulin(mU/L) × fasting glucose(mg/dL)"|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.|||percentage of beta cell function||Standard Deviation|Mean
2683769|NCT01373346|Secondary|HOMA-IR|"HOMA-IR(Homeostasis model assessment-estimated insulin resistance) was measured.~HOMA-IR was obtained using the following formula:~Glucose(mg/dl) x Insulin/405"|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.|||units on a scale||Standard Deviation|Mean
2683770|NCT01373346|Secondary|QUICKI|"The quantitative insulin sensitivity check index (QUICKI) was measured.~The QUICKI was obtained using the following formula:~1 / (log(fasting insulin µU/mL) + log(fasting glucose mg/dL))"|Before operation , 6 months after operation , Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.|||units on a scale||Standard Deviation|Mean
2683922|NCT01371838|Secondary|Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in MITT Population||7-20 days after last day of study drug administration|All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV.|||Participants|||Number
2683771|NCT01373346|Primary|Morbidity|"For the evaluation of safety, morbidity were analyzed. For the evaluation of short-term safety, complications higher than the Clavien-Dindo grade II (Dindo et. Ann Surg 240:205 2004) were collected.~*Clavien-dindo classification of surgical complications Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.~Grade III: Requiring surgical, endoscopic or radiological intervention Grade IV:Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management Grade V:Death of a patient Suffix'd' : If the patient suffers from a complication at the time of discharge ,the suffix d (for 'disability') is added to the respective grade of complication. This label indicates the need for a follow-up to fully evaluate the complication.~For the evaluation of long-term safety, the patients were evaluated every month after discharge."|Until end of study (on average 14.8 months)|All of enrolled patient were included. (N=15)|||participants|||Number
2683772|NCT01373346|Secondary|Matsuda Index|"Matsuda Index(Insulin Sensitivity Index) was measured.~The Matsuda index was obtained using the following formula:~Matsuda index = 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during OGTT)]"|Before operation , 6 months after operation, Until end of study (on average 14.8 months)|Fifteen patients were enrolled for this study. During the follow-up period, there was one patient, who had poorly differentiated neuroendocrine carcinoma which is one of most aggressive gastric cancer, and died due to recurrence four months after surgery. The patient who died of recurrence was excluded from the efficacy evaluation.|||units on a scale||Standard Deviation|Mean
2683773|NCT01373294|Other Pre-specified|Comparison of the Correlative Assay|For comparing the correlative assay results of ever-relapsers vs non-relapsers, the combined data with the monotherapy and combination therapy groups would be applied. The participants would be categorized based on 1-year relapse.|1 year post disease response|||||||
2683774|NCT01373294|Other Pre-specified|Effect of Addition of Revlimid on Cytokines|The immunologic impact of the addition of Revlimid™ to BCG for secondary prevention of non-muscle-invasive transitional cell bladder cancer, in terms of a panel of correlative assays. The effect of addition of Revlimid on cytokines associated with generation of immune response and on cytotoxic T lymphocytes and memory phenotype lymphocytes.|Duration of study treatment and follow-up - average of 12 months|||||||
2683775|NCT01373294|Secondary|Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|Number of participants with treatment emergent AEs or SAEs per category. SAEs will be specifically labeled as such. Participants were assessed at monthly intervals (corresponding to Revlimid™ refill points for adverse events), classified by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, and these were tabulated.|Duration of study treatment and follow-up - average of 12 months|All participants.|||participants|||Number
2683776|NCT01373294|Primary|Arm A: Progression Free Survival (PFS)|The 1-year progression free/ recurrence free/ bladder-intact survival was tabulated for the experimental arm for a median follow-up period of 369 days. The progression free/ recurrence free/ bladder-intact survival is defined as the time from start of study treatment to first documentation of objective tumor progression, recurrence, bladder resection or irradiation or to death due to any cause, whichever comes first. PFS data was not collected for participants in the Arm B: Control because too few participants were enrolled in Arm B to conduct the planned per Arm comparison|1 year|Experimental Arm A Group Only.|||participants|||Number
2683777|NCT01373281|Secondary|Number of Hospitalized VCD Cases During the Surveillance Expansion Period Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo|Hospitalized VCD cases were defined as VCD confirmed by dengue RT-PCR and/or dengue NS1 ELISA in participants with acute febrile illness (temperature >= 38°C on at least 2 consecutive days) requiring hospitalization.|From consent to participate in the Surveillance Expansion Period to 60 months post-injection 3 (up to Month 72)|Number of hospitalized dengue hemorrhagic fever cases were assessed in the Safety Analysis Set.|||Cases|||Number
2683778|NCT01373281|Secondary|Number of Hospitalized VCD Cases Throughout the Trial Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo|Hospitalized VCD cases were defined as VCD confirmed by dengue RT-PCR and/or dengue NS1 ELISA in participants with acute febrile illness (temperature >=38°C on at least 2 consecutive days) requiring hospitalization.|Day 0 to the end of study (up to 72 months)|Number of hospitalized dengue hemorrhagic fever cases were assessed in the Safety Analysis Set. Here, ‘number analyzed’ = participants with available data for specified category.|||Cases|||Number
2683779|NCT01373281|Secondary|Number of Participants With Systemic Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo|Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever, >= 39°C; Headache, Malaise, Myalgia, and Asthenia, Significant, prevents daily activity.|Within 14 days after injection|Solicited systemic reactions were assessed in a subset of the Safety Analysis Set, which included all participants who received at least one dose of study vaccine.|||participants|||Number
2683780|NCT01373281|Secondary|Number of Participants With Solicited Injection Site Reactions Following Any and Each Inj. With Either CYD Dengue Vaccine or a Placebo|Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions (2-11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, >= 50 mm. Grade 3 Solicited injection site reactions (12-14 years): Pain, Significant, prevents daily activity; Erythema and Swelling, >100 mm.|Within 7 days after injection|Solicited injection site reactions were assessed in a subset of the Safety Analysis Set, which included all participants who received at least one dose of study vaccine.|||participants|||Number
2683787|NCT01373281|Secondary|Number of Symptomatic VCD Cases Due to Any Serotype Occurring 28 Days Post-dose 1 Following Injection With Either CYD Dengue Vaccine or a Placebo|Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature >= 38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue reverse transcriptase polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Vaccine Group.|28 days post-injection 1 and up to 13 months post-injection 3|Number of symptomatic VCD cases were assessed in the Full Analysis Set for Efficacy, which included participants who received at least 1 dose of study vaccine.|||Cases|||Number
2689510|NCT01326845|Secondary|Difference in Frequency of Overall Newly Occurring GI AEs Between the Two Treatment Groups at Month 6.|Study was prematurely terminated and not powered for efficacy.|6 months|||||||
2683781|NCT01373281|Secondary|Number of Clinically Severe VCD Cases During the Surveillance Expansion Period Due to Any Serotype Following Inj. With Either CYD Dengue Vaccine or a Placebo|The severity of VCD cases was assessed by an IDMC based on a medical review of cases and any of the following criteria:1) Platelet count <=100000μl and bleeding (tourniquet, petechiae or any bleeding) plus plasma leakage 2) Shock (pulse pressure <= 20mmHg in a child, or hypotension [<= 90 mmHg] with tachycardia, weak pulse and poor perfusion) 3) Bleeding requiring blood transfusion 4) Encephalopathy i.e. Unconsciousness or poor conscious state or fitting not attributable to simple febrile convulsion or focal neurological signs. Poor conscious state or unconsciousness must be supported by GCS score 5) Liver impairment (AST >1000 IU/L or PT INR >1.5) excluding other causes of viral hepatitis 6) Impaired kidney function (serum creatinine >= 1.5 mg/dL) 7) Myocarditis, pericarditis or clinical heart failure supported by CXR, echocardiography, ECG or cardiac enzymes.|From consent to participate in the Surveillance Expansion Period to 60 months post-injection 3 (up to Month 72)|Number of clinically severe VCD cases were assessed in the Full Analysis Set for SEP.|||Cases|||Number
2683782|NCT01373281|Secondary|Number of Clinically Severe VCD Cases Throughout the Trial Due to Any Serotype Following Inj. With Either CYD Dengue Vaccine or a Placebo|The severity of VCD cases was assessed by an IDMC based on a medical review of cases and any of the following criteria:1) Platelet count <=100000 μl and bleeding (tourniquet, petechiae or any bleeding) plus plasma leakage 2) Shock (pulse pressure <= 20 mmHg in a child, or hypotension [<= 90 mmHg] with tachycardia, weak pulse and poor perfusion) 3) Bleeding requiring blood transfusion 4) Encephalopathy i.e. Unconsciousness or poor conscious state or fitting not attributable to simple febrile convulsion or focal neurological signs. Poor conscious state or unconsciousness must be supported by GCS score 5) Liver impairment (AST >1000 IU/L or PT INR >1.5) excluding other causes of viral hepatitis 6) Impaired kidney function (serum creatinine >= 1.5 mg/dL) 7) Myocarditis, pericarditis or clinical heart failure supported by CXR, echocardiography, ECG or cardiac enzymes.|Day 0 to the end of study (up to 72 months)|Number of clinically severe VCD cases were assessed in the Safety Analysis Set. Here, ‘number analyzed’ = participants with available data for each specified category.|||Cases|||Number
2683783|NCT01373281|Secondary|Number of Symptomatic VCD Cases Meeting 1997 WHO Criteria During the Surveillance Expansion Period Due to Any Serotype Following Inj. With Either CYD Dengue Vaccine or a Placebo|The 1997 WHO criteria are: a) Fever: acute onset, high (>= 38°C) and continuous, for 2 to 7 days and (b) any of the following: thrombocytopenia (platelet <=100 x 109/L) and plasma leakage as shown by hematocrit increased by 20% or more or pleural effusion and/or ascites and/or hypoaluminemia. The first two clinical criteria plus thrombocytopenia and signs of plasma leakage are enough to establish diagnosis of DHF. Dengue hemorrhagic fever was graded as follows:Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test; Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participant,usually in the form of skin and/or other hemorrhages; Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness; and Grade IV: Profound shock with undetectable blood pressure and pulse.|From consent to participate int the Surveillance Expansion Period to 60 months post-injection 3 (up to Month 72)|Number of WHO dengue hemorrhagic fever cases were assessed in the Full Analysis Set for Surveillance Expansion Period, which included all participants who received at least 1 injection and accepted to be included in the Surveillance Expansion Period.|||Cases|||Number
2683784|NCT01373281|Secondary|Number of Symptomatic VCD Cases Meeting 1997 WHO Criteria Throughout the Trial Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo|"Dengue hemorrhagic fever cases were defined as number of participants with at least one symptomatic VCD episode meeting the 1997 WHO criteria.~(a) Fever: acute onset, high (>= 38°C) and continuous, lasting 2 to 7 days and (b) any of the pre-listed hemorrhagic manifestations and laboratory findings of thrombocytopenia (platelet <=100 x 109/L) and plasma leakage as shown by hemoconcentation (hematocrit increased by 20% or more) or pleural effusion (seen on CXR) and/or ascites and/or hypoaluminemia. The first two clinical criteria plus thrombocytopenia and signs of plasma leakage are enough to establish a clinical diagnosis of DHF. Dengue hemorrhagic fever was graded as follows: Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test; Grade II: Spontaneous bleeding in addition to the manifestations of Grade I participants, usually in the form of skin and/or other hemorrhage."|Day 0 to the end of study (up to 72 months)|Number of WHO dengue hemorrhagic fever cases were assessed in the Safety Analysis Set, which included all participants who received at least one dose of study vaccine. Here, ‘number analyzed’ = participants with available data for each specified category.|||Cases|||Number
2683785|NCT01373281|Secondary|Number of Symptomatic VCD Cases Due to Any Serotype During the Active Phase in Either CYD Dengue Vaccine or Placebo Group|Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature >=38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue reverse transcriptase polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Vaccine Group.|Day 0 up to 13 months post-injection 3|Number of symptomatic VCD cases were assessed in the Full Analysis Set for Efficacy, which included all participants who received at least 1 injection.|||Cases|||Number
2683786|NCT01373281|Secondary|Number of Symptomatic VCD Cases Due to Any Serotype 28 Days Post-dose 2 Following Injection With Either CYD Dengue Vaccine or a Placebo|Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature >= 38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue reverse transcriptase polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Vaccine Group.|28 days post-injection 2 and up to 13 months post-injection 3|Number of symptomatic VCD cases were assessed in the Other Efficacy Analysis Set, which included participants who received at least 2 doses of study vaccine.|||Cases|||Number
2683826|NCT01372995|Secondary|Change in Plasma LL-37 Levels|Plasma LL-37 was measured at Baseline, Day 7 and Day 14.|Baseline, Day 7, Day 14|For the Day 14 analysis there were 8 participants in the Placebo arm, 6 participants in the 250,000 of Vitamin D arm, and 5 participants in the 500,000 of Vitamin D arm.|||ng/mL||Inter-Quartile Range|Median
2683788|NCT01373281|Secondary|Percentage of Participants With Antibody Titers >= 10 1/Dilution (1/Dil) Against Each Dengue Virus Serotype Strain Before and Following Inj. With CYD Dengue Vaccine or Placebo|Percentage of participants with antibody titers >= 10 (1/Dil) against each serotypes of the dengue virus strains were assessed using PRNT in a pre-defined subset of participants.|Pre-injection 1, 28 days post Injections 2 and 3, 13 months (V 07) and 60 months (V 12) post-injection 3|Antibody titers against each dengue virus serotype strain were assessed in FASI, which included a subset of participants who received at least one dose of vaccine and had a blood sample drawn and result available after the dose. Here, ‘number analyzed’ = participants with available data for each specified category.|||Percentage of participants|||Number
2683789|NCT01373281|Secondary|Geometric Mean Titers of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo|Geometric mean titers against each of the 4 serotypes of dengue virus strains were assessed using the plaque reduction neutralization test (PRNT) in a pre-defined subset of participants.|Pre-injection 1, 28 days post Injections 2 and 3, 13 months (Visit 07) and 60 months (Visit 12) post-injection 3|Antibody titers against each dengue virus serotype strain were assessed in Full Analysis Set for Immunogenicity(FASI),which included a subset of participants who received at least one dose of vaccine and had a blood sample drawn and result available after the dose. Here,‘number analyzed’=participants with available data for each specified category.|||Titers (1/dilution)||95% Confidence Interval|Geometric Mean
2683790|NCT01373281|Primary|Number of Symptomatic Virologically Confirmed Dengue (VCD) Cases Due to Any Serotype During the Active Phase Post-dose 3 Following Injection (Inj.) With Either CYD Dengue Vaccine or a Placebo|Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature >=38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue reverse transcriptase polymerase chain reaction and/or dengue NS protein 1 antigen enzyme-linked immunosorbent assay. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Vaccine Group.|28 days and up to 13 months post-dose 3|Number of symptomatic VCD cases were assessed in the Per-Protocol Analysis Set for Efficacy|||Cases|||Number
2683791|NCT01373242|Secondary|Change in Peanut IgG4 Over Time Among Subjects Who Were Induced With Clinical Desensitization Versus Those Who Failed|Comparative estimates of changes in immune parameters (serum levels of peanut-specific IgG4 in mg/L) from baseline through end of treatment among subjects who were induced with clinical desensitization (ingesting 5000mg on DBPCFC without symptoms) versus those who failed (developing clinical symptoms after ingesting 5000mg on DBPCFC).|48 months||||mg/L||Full Range|Median
2683792|NCT01373242|Secondary|Change in Peanut IgE Over Time Among Subjects Who Were Induced With Clinical Desensitization Versus Those Who Failed|Comparative estimates of changes in immune parameters (serum levels of peanut specific IgE in kU/L) from baseline through end of treatment among subjects who were induced with clinical desensitization (ingesting 5000mg on DBPCFC without symptoms) versus those who failed (developing clinical symptoms after ingesting 5000mg on DBPCFC).|48 months||||kU/L||Full Range|Median
2683793|NCT01373242|Secondary|Change in Peanut Skin Test Wheal Over Time Among Subjects Who Were Induced With Clinical Desensitization Versus Those Who Failed|Comparative estimates of changes in immune parameters (wheal size in mm during peanut skin prick test) from baseline through end of treatment among subjects who were induced with clinical desensitization (ingesting 5000mg on DBPCFC without symptoms) versus those who failed (developing clinical symptoms after ingesting 5000mg on DBPCFC).|48 months||||mm||Full Range|Median
2683794|NCT01373242|Secondary|Number of Participants With Gastrointestinal and Possible Gastrointestinal Eosinophilic Adverse Events.|With published concerns for the development of eosinophilic gastrointestinal disease after food immunotherapy, will report the number of participants with gastrointestinal and possible gastrointestinal eosinophilic adverse events during SLIT therapy|48 months||||Participants|||Count of Participants
2683795|NCT01373242|Secondary|Number of Participants With Adverse Events and Serious Adverse Events During the Study.|Number of participants with adverse events (AEs) and serious adverse events (SAEs) during the SLIT treatment portion of the study.|48 months||||Participants|||Count of Participants
2683796|NCT01373242|Primary|Population Estimate of a Subject's True Sensitivity Threshold to Decrease by One Dose Level of During the DBPCFC|A population estimate of time to loss of desensitization will be calculated for a subject's true sensitivity threshold (LOAEL) to decrease by one dose level during the double-blind, placebo-controlled food challenge. Food challenge dose levels are as follows: 100 mg, 200 mg, 500 mg, 800 mg, 1300 mg, 2100 mg. This is calculated based on the Kaplan-Meier estimator of the survival function using study participant data.|52 months||||weeks|||Number
2683797|NCT01373242|Primary|Population Estimate of a Subject's True Sensitivity Threshold to Maintain at the Same Dose Level During DBPCFC|A population estimate of time to loss of desensitization will be calculated for a subject's true sensitivity threshold (LOAEL) to maintain at the same dose level during the double-blind, placebo-controlled food challenge. Food challenge dose levels are as follows: 100 mg, 200 mg, 500 mg, 800 mg, 1300 mg, 2100 mg. This is calculated based on the Kaplan-Meier estimator of the survival function using study participant data.|52 months||||weeks|||Number
2683798|NCT01373242|Primary|Population Estimate of Time for a Subject's True Sensitivity Threshold to Reduce by Half.|A population estimate of time to loss of desensitization will be calculated for a subject's true sensitivity threshold (LOAEL) to reduce by half, also called half-life of sensitivity threshold. This is calculated based on the Kaplan-Meier estimator of the survival function using study participant data.|52 months||||weeks|||Number
2683799|NCT01373242|Primary|Population Sensitization Threshold in mg Peanut Protein Predicted to Provoke Reactions in 10% of the Peanut-allergic Population|An estimate of the dose as assessed by the 48th month DBPCFC reported in mg peanut protein, also called population sensitization threshold, predicted to provoke reactions in 10% of the peanut-allergic population. This will also give population level no observed adverse event level (NOAEL) and lowest observed adverse event level (LOAEL) that would define interval of consecutive administered dose levels within which the population sensitization threshold lies. NOAEL is the highest dose observed not to produce any adverse effect and LOAEL is the lowest dose that is observed to produce an adverse effect.|48-52 months||||mg|||Number
2685196|NCT01361633|Secondary|Wisconsin Card Sort Test|Assesses executive functioning|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up|||||||
2683800|NCT01373242|Primary|Population Sensitization Threshold in mg Peanut Protein Predicted to Provoke Reactions in 5% of the Peanut-allergic Population|An estimate of the dose as assessed by the 48th month DBPCFC reported in mg peanut protein, also called population sensitization threshold, predicted to provoke reactions in 5% of the peanut-allergic population. This will also give population level no observed adverse event level (NOAEL) and lowest observed adverse event level (LOAEL) that would define interval of consecutive administered dose levels within which the population sensitization threshold lies. NOAEL is the highest dose observed not to produce any adverse effect and LOAEL is the lowest dose that is observed to produce an adverse effect.|48 - 52 months||||mg|||Number
2683801|NCT01373229|Secondary|Reduction in the Frequency of Blood and Platelet Transfusions|The change in number of transfusions from pre- to post-treatment will be calculated and summarized across all patients by giving the minimum, the 25th, 50th (median) and the 75th percentile and the maximum.|4 weeks prior to therapy and in the 4 weeks following the completion of therapy|Data were not collected and the Outcome will never be analyzed||||||
2683802|NCT01373229|Secondary|Reduction in Severity of B Symptoms|Reduction in the severity of the following B symptoms will be assessed: fever ≥ 101F, chills, night sweats, and anorexia with weight loss.|at the end of stage 1 (lenalidomide alone), at the end of stage 2 (4 months of combination), and at 2 months post-completion of therapy|Data were not collected and the Outcome will never be analyzed||||||
2683803|NCT01373229|Secondary|Overall Survival (OS)||the time from day 1 of treatment to death or 2 years, whichever comes first|Subjects who died on study|||months||Standard Deviation|Mean
2683804|NCT01373229|Secondary|Progression-free Survival (PFS)||time from day 1 of treatment to disease progression, death, or 2 years, whichever comes first|Subjects who experienced disease progression|||months||Standard Deviation|Mean
2683805|NCT01373229|Secondary|Overall Response (Complete Response/Partial Response)|"NCI 96 Response Criteria~CR (Complete Response):~Lymphadenopathy = none > 1.5cm Hepatomegaly = none Splenomegaly = none Blood lymphocytes = <4000 per microliter Marrow = normocellular, <30% lymphocytes, no B-lymphoid nodules. Platelet count = >100,000 per microliter Hemoglobin = >11.0 grams per deciliter Neutrophils = >1500 per microliter~PR (Partial Response):~Lymphadenopathy = Decrease >/= 50% Hepatomegaly = Decrease >/= 50% Splenomegaly = Decrease >/= 50% Blood lymphocytes = Decrease >/= 50% from baseline Marrow = 50% reduction in marrow infiltrate or B-lymphoid nodules. Platelet count = >100,000 per microliter or increase >/= 50% over baseline Hemoglobin = >11.0 grams per deciliter or increase >/= 50% over baseline Neutrophils = >1500 per microliter or increase >/= 50% over baseline"|at the end of 4 months of combination treatment and at 2 months after completion of therapy|Three (3) subjects were unable to complete the run-in phase. Three (3) subjects died prior to completing stage 2, and three (3) subjects were unable to complete 4 cycles of combination therapy. Therefore, only 6 subjects were analyzed for response.|||Participants|||Count of Participants
2683806|NCT01373229|Primary|Maximum Tolerated Dose||4-16 months||||mg/kg|||Number
2683807|NCT01373164|Secondary|Phase 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA19-9) Level at First Study Completion Follow-up|Carbohydrate antigen 19-9 (CA 19-9) is a modified Lewis(a) blood group antigen, and has been used as a tumor marker. The outcome measure is the median, minimum and maximum values from participants who had samples collected at baseline and at follow-up|Baseline, study treatment completion after first follow up visit (up to 1 year)|All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for CA19-9 level.|||Units/Milliliter (U/mL)||Full Range|Median
2683808|NCT01373164|Secondary|Phase 2: Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) at Study Completion|The BPI-SF Pain Severity Subscale was a participant-rated questionnaire that measured the severity of pain. Severity scores could have ranged from 0 (no pain) to 10 (pain as bad as you can imagine) for questions that included assessing average pain in the past 24 hours.|Baseline, study treatment completion (up to 1 year)|All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for BPI-sf.|||Units on a scale||Standard Deviation|Mean
2683809|NCT01373164|Secondary|Phase 2: Population PK: Maximum Concentration (Cmax) of Galunisertib|Plasma samples for pharmacokinetic (PK) analysis were obtained on Day 14 at 0 hours (Pre-dose), 0.5, 2, 3, 6 hours post dose and morning doses from 24h and 48h. Cmax takes all time points post dose into account and one value is reported.|Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)|All randomized participants who received at least 1 dose of study drug with evaluable PK data.|||ng/mL||Inter-Quartile Range|Mean
2683810|NCT01373164|Secondary|Phase 2: Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24])|AUC[0-24] is a combined measure obtained from Day 14 at 0 hour (pre-dose), 0.5, 2,3, 6 hours post dose and morning doses from 24h and 48h to compute.|Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)|All randomized participants who received at least 1 dose of study drug with evaluable PK data.|||mg*h/L||Inter-Quartile Range|Mean
2683811|NCT01373164|Secondary|Phase 2: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Overall Response Rate[ORR])|Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.|Baseline to measured progressive disease (up to 2 years)|All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for ORR.|||Percentage of Participants||95% Confidence Interval|Number
2683812|NCT01373164|Secondary|Phase 2: Percentage Change From Baseline in Tumor Size (CTS)|Change in tumor size is defined as the maximum percent change from baseline in the sum of target lesions. Change was assessed in each participant using radiographic imaging.|Baseline, end of Cycle 2 (up to 56 days)|All randomized participants who received at least 1 dose of study drug and had baseline and a post-baseline measurement for change in tumor size.|||Percent change in tumor size||95% Confidence Interval|Geometric Mean
2696845|NCT01265875|Secondary|Number of Participants With Serious Adverse Events.||30 Days||||participants|||Number
2683813|NCT01373164|Secondary|Phase 2: Progression Free Survival (PFS)|PFS is defined as the date of randomization to the first date of progression of disease or of death from any cause. For each participant who is not known to have died or to have had a progression of disease as of the data-inclusion cut-off date for a particular analysis, PFS will be censored at the date of last prior contact. PFS will be calculated and analyzed twice: (1) including clinical progressions of disease not based on lesion measurements, and (2) excluding clinical progressions. Progression Disease (PD) was defined as having at least a 25% increase in the sum of the longest diameter of target lesions.|Baseline to first date of progressive disease or death due to any cause (up to 2 years)|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline observation. Number of participants censored were Galunisertib + Gemcitabine = 21 and Placebo + Gemcitabine = 11.|||Months||95% Confidence Interval|Median
2683814|NCT01373164|Secondary|Phase 1b: Number of Participants With Tumor Response|Response was defined using RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria.|Baseline to end of Phase 1b (up to 1 year)|Phase 1b: All participants who received at least one dose of study drug.|||Participants|||Number
2683815|NCT01373164|Secondary|Phase 1b: Pharmacokinetics: Maximum Plasma Drug Concentration at Steady State (Cmax,ss)|Plasma samples for pharmacokinetic (PK) analysis were obtained on Day 14 at 0 hours (Pre-dose), 0.5, 2, 3, 6 hours post dose and morning doses from 24h and 48h. Cmax takes all time points post dose into account and one value is reported.|Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)|Phase 1b: All participants who received at least one dose of study drug and had evaluable PK data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2683816|NCT01373164|Secondary|Phase 1b: Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 24 Hours (AUC[0-24], ss) and Time Zero to Infinity (AUC[0-∞], ss)|AUC[0-24h] is a combined measure obtained from Day 14 at 0 hour (pre-dose), 0.5, 2,3, 6 hours post dose and morning doses from 24h and 48h to compute. AUC0-infinity will take 48h and extrapolation beyond this in addition to earlier time points to be calculated. All mentioned time points are used to calculate the two AUCs.|Cycle 1 Days 14 (predose; 0.5, 2, 3, and 6 hours post dose), 24h (Days 15) and 48h (Days 16)|Phase 1b: All participants who received at least one dose of study drug and had evaluable PK (pharmacokinetics) data.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2683817|NCT01373164|Primary|Phase 2: Overall Survival (OS)|Overall survival is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date for a particular analysis, overall survival duration was censored for that analysis at the date of last prior contact.|Baseline to date of death from any cause (up to 2 years)|All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline observation. Number of participants censored were Galunisertib + Gemcitabine = 20 and Placebo + Gemcitabine = 4.|||Months||95% Confidence Interval|Median
2683818|NCT01373164|Primary|Phase 1b: Recommended Phase 2 Dose|The recommended Phase 2 dose was the highest dose where less than 1/3 of participants experienced dose limiting toxicities (DLTs). The recommended dose was determined based on a review of overall toxicity, dose reductions, omissions, and pharmacokinetic information from Phase 1b.|Time of first phase 1b dose until time of last phase 1b dose (up to 1 year)|Phase 1b: All participants who received at least one dose of study drug.|||milligrams (mg)|||Number
2683819|NCT01372995|Secondary|Day 84 Mortality|The number of participants who died prior to the end of the study (Day 84) was collected.|Day 84|The number of participants in the hospital mortality analysis for the arm receiving 500,000 IU of Vitamin D3 was 10, rather than 11, as one participant withdrew.|||participants|||Number
2683820|NCT01372995|Secondary|Number of Hospital Mortality Cases|The number of study participants who died while in the hospital was collected.|12 weeks|The number of participants in the hospital mortality analysis for the arm receiving 500,000 IU of Vitamin D3 was 10, rather than 11.|||participants|||Number
2683821|NCT01372995|Secondary|Number of Hospital Acquired Infections|The number of study participants who had a hospital acquired infection.|12 weeks||||participants|||Number
2683822|NCT01372995|Secondary|Change in Sequential Organ Failure Assessment (SOFA) Score|Change in Sequential Organ Failure Assessment (SOFA) score between Baseline and Day 7. The Sequential Organ Failure Assessment (SOFA) score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems (respiratory, nervous, cardiovascular, liver, coagulation, and kidneys). A score ranges from 0-24. 0 (normal) to 4 (high degree of dysfunction) is given for each organ system, with a higher score indicating greater severity. A score of 0-6 is associated with a mortality rate of less than 10% while a score between 16 and 24 is associated with a greater than 90% mortality rate. Scores decreasing between the Baseline and Day 7 measurements are represented as negative values for the change in SOFA score.|Baseline, Day 7|SOFA score obtained daily while in the ICU. The portion of the study participants included in the analysis of the change in SOFA score between Baseline and Day 7 is limited to participants having values for both time points..|||units on a scale||Standard Deviation|Mean
2683823|NCT01372995|Secondary|Duration of Time in Hospital|The number of days that each participant spent in the hospital was collected and the average number of days for each study arm is reported.|12 weeks||||days||Standard Deviation|Mean
2683824|NCT01372995|Secondary|Duration of Time in Intensive Care Unit (ICU)|The number of days spent in the intensive care unit (ICU) was collected for each participant and the average number of days for each study arm is reported.|12 weeks||||days||Standard Deviation|Mean
2683825|NCT01372995|Secondary|Duration of Time on Ventilator|The number of days spent on mechanical ventilation was collected for all study participants and the average number of days for each study arm is reported.|12 weeks||||days||Standard Deviation|Mean
2690088|NCT01319877|Secondary|One-year Survival Rate by the Chemotherapy Regimen Subgroup||1 year|Participants with known prior chemotherapy regimens were evaluated|||percentage of participants||95% Confidence Interval|Number
2683831|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Day 7|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the Day 7 measurement.|Day 7|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. The number of participants analyzed at each time point decreased over the course of the study as participants were discharged from the hospital.|||participants|||Number
2683832|NCT01372995|Primary|Number of Participants With Plasma 25(OH)D Concentration >30ng/mL at Baseline|The number of participants with a plasma 25(OH)D concentration in the desirable range (defined as greater than 30 ng/mL) at the baseline measurement.|Baseline|Blood samples were obtained every 7 days while participants remained hospitalized. Follow up discontinued once the participant was discharged from the hospital. At the baseline time point, 10 patients were randomized to the placebo arm, 9 to the arm receiving 250,000 IU of Vitamin D3, and 11 to the arm receiving 500,000 of Vitamin D3.|||participants|||Number
2683833|NCT01372878|Secondary|Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥10 mm Where OC Considered as the Gold Standard Reference|Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 6 mm. For a given polyp, a match between the PillCam Colon 2 Capsule and optical colonoscopy was considered if the polyp size was assessed within plus or minus 50% of the size of the estimate of the OC measurement and the polyp as appearing within the same colon segment or in adjacent segments. The polyp size measurement by optical colonoscopy was used as the reference standard.|1 year, same as study duration||||percentage of participants||95% Confidence Interval|Number
2683834|NCT01372878|Primary|Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥6 mm Where OC Considered as the Gold Standard Reference|"Sensitivity and specificity of PillCam Platform with the PillCam COLON 2 capsule in detecting subjects with polyps equal to or larger than 6 mm. For a given polyp, a match between the PillCam Colon 2 Capsule and optical colonoscopy was considered if the polyp size was assessed within plus or minus 50% of the size of the estimate of the OC measurement and the polyp as appearing within the same colon segment or in adjacent segments. The polyp size measurement by optical colonoscopy was used as the reference standard.~Sensitivity measures the proportion of actual positives which are correctly identified as such.~Specificity measures the proportion of negatives which are correctly identified as such.~positive event defined as patients with polyps ≥6 mm detected by OC procedure."|1 year, same as study duration||||percentage of participants||95% Confidence Interval|Number
2683835|NCT01372813|Secondary|Evaluate The Correlation Between Von Hippel-Lindau (VHL) Mutational Status and Response to ZD6474 (Vandetanib)|If an adequate number of responses were seen, the relation of these responses to the presence/absence of inactivating VHL mutations in tumor tissue would have been assessed.|12 months|Not enough samples for meaningful analysis.||||||
2683836|NCT01372813|Secondary|The Effects of ZD6474 (Vandetanib) on Tumor Microvessel Density|Tumor tissue sections were to be stained with hematoxylin and eosin (H and E) and endothelial cell markers at baseline and specified timepoints following initiation of therapy (when tumor tissue was available)|12 months|Not enough samples for meaningful analysis.||||||
2683837|NCT01372813|Secondary|Tumor Tissue Used to Evaluate Von Hippel-Lindau (VHL) Status and/or Components of the Vascular Endothelial Growth Factor (VEGF)/Epidermal Growth Factor Receptor (EGFR) Pathway|Components of the VEGF and EGFR pathways were to be evaluated using Western blot analysis at baseline and specified timepoints following initiation of therapy when tumor tissue was available.|12 months|Not enough samples for meaningful analysis.||||||
2683838|NCT01372813|Secondary|Number of Participants With Vandetanib (ZD6474) Effects on Tumor Vascular Flow and Permeability Using Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI)|Flow dynamics within specific tumor sites will be evaluated based on the results of the DCE-MRI obtained first without contrast enhancement and then after contrast enhancement. The parameter to be measured is the forward contrast transfer rate (Ktrans), the reverse contrast transfer rate (Kep), and/or the extravascular extracellular space volume fraction (Ve). Flow dynamics are a measure of blood flow changes in the tumor and are determined using the parameters previously defined (Ktrans, Kep, etc.).|12 months||||Participants with changes|||Number
2683839|NCT01372813|Secondary|Number of Circulating Endothelial Cells (CEC) Per 10^6 Mononuclear Cells or Per Microliter of Peripheral Blood Analyzed in Samples Taken Before and After Treatment|CEC cell concentrations are calculated as a percentage of the total number of mononuclear cells or as the number of cells/microliter of whole blood after an evaluation of a minimum of 10^5 cellular events, and preferably 10^6 cellular events.|12 months|Not enough samples for meaningful analysis.||||||
2683840|NCT01372813|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|11.5 months||||Participants|||Number
2683841|NCT01372813|Secondary|Progression-free Survival as Defined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|"Progression free survival is defined as the time from initiation of treatment to either progression or death.~RECIST evaluates tumor response. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. For detailed information about RECIST, see the protocol Link module."|12 months||||Days||95% Confidence Interval|Median
2683842|NCT01372813|Secondary|Number of Circulating Endothelial Progenitor Cells (CEP) Per 10^6 Mononuclear Cells or Per Microliter of Peripheral Blood Analyzed in Samples Taken Before and After Treatment|CEP cell concentrations are calculated as a percentage of the total number of mononuclear cells or as the number of cells/microliter of whole blood after an evaluation of a minimum of 10^5 cellular events, and preferably 10^6 cellular events.|12 months|Not enough samples for meaningful analysis.||||||
2683843|NCT01372813|Secondary|Effect of Vandetanib on Plasma Biomarkers-vascular Endothelial Growth Factor (VEGF), Vascular Endothelial Growth Factor 2 (VEGFR2)|Plasma VEGFR and VEGFR2 would have been measured using the (enzyme-linked immunosorbent assay)ELISA at baseline and specified timepoints following initiation of therapy.|12 months|Not enough samples for meaningful analysis.||||||
2684068|NCT01370629|Primary|Number of Participants Experiencing Significant Hypotension|Significant hypotension is defined as: symptomatic hypotension with systolic blood pressure (BP) <90 mmHg, requiring treatment with vasopressors|Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion||||Participants|||Count of Participants
2683844|NCT01372813|Primary|Number of Participants With a Clinical Response (Partial Response (PR) + Clinical Response (CR))|Clinical response is the best response recorded from the start of treatment until disease progression. Clinical response is assessed by the Response Evaluation in Solid Tumors (RECIST) criteria. A partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. A complete response (CR) is the disappearance of all target lesions.|12 months||||Participants|||Number
2683845|NCT01372774|Secondary|Change in Quality-of-life at 6 Months|Clinically significant change in quality of life is defined as ten-point change on QOL scores (transformed to a 0 to 100 scale). As measured by the overall score from the FACT-Br. An improvement is defined as a change greater than or equal ten points.|Up to 6 months post randomization|Only patients with baseline and 6 month QOL assessment scores were included in this analysis.|||participants|||Number
2683846|NCT01372774|Secondary|Time to CNS Failure in These Patients||Up to 5 years post radiation||||Months||95% Confidence Interval|Median
2683847|NCT01372774|Secondary|Local Control of the Surgical Bed|Local control of the surgical bed means that tumor did not recur at the unresected metastases treated with stereotactic radiosurgery, SRS, or whole brain radiotherapy, WBRT. Intercranial Brain Control Rates estimated via 1-Cumulatice Incidence Rate from Competing Risk survival analysis of time to the specific recurrence type. Deaths without recurrence are censored at time of death.|Up to 6 months post radiation||||percentage of patients||95% Confidence Interval|Number
2683848|NCT01372774|Primary|Overall Survival|To determine in patients with one to four brain metastases whether there is improved overall survival in patients who receive SRS to the surgical bed compared to patients who receive WBRT. Overall survival is defined as the time from randomization to death from any cause.|from baseline up to 5 years post radiation|All enrolled patients were included in the analysis of this outcome. This includes the 9 patients that did not receive treatment.|||months||95% Confidence Interval|Median
2683849|NCT01372774|Primary|Cognitive Deterioration Free Survival Post-radiation in Patients Who Received SRS Compared to Patients Who Received WBRT|To determine in patients with one to four brain metastases whether there is less nuerocognitive progression post-randomization in patients who receive SRS to the surgical bed compared to patients who receive WBRT. Neurocognitive progression is defined as a drop of at least one stanard deviation from baseline in one of the six neurocognitive tests at post-randomization evaluation.|from baseline up to 5 years post radiation|All enrolled patients were included in the analysis of this outcome. This includes the 9 patients that did not receive treatment.|||Months||95% Confidence Interval|Median
2683850|NCT01372748|Secondary|Percentage of Participants Scoring at or Below a 3 on the MRS Scale|Neurologic status at discharge will be assessed using the modified Rankin Score (MRS). A higher value indicates a worse outcome. 0-No symptoms at all; 1-No significant disability despite symptoms; able to carry out all usual duties and activities, 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3-Moderate disability; requiring some help, but able to walk without assistance; 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6-Dead|Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.||||percentage of participants|||Number
2683851|NCT01372748|Primary|Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge|Patients may die in the field (outside of the hospital at the time of the cardiac arrest), at the emergency room, in the hospital, or they are discharged alive from the hospital.|Patients will be followed from the time of the cardiac arrest until death or hospital discharge, whichever occurs first.|The primary aim of the trial is to compare survival to hospital discharge after continuous chest compressions (CCC) versus standard American Heart Association (AHA) recommended cardiopulmonary resuscitation (CPR) with interrupted chest compressions (ICC) in patients with out-of-hospital cardiac arrest (OOHCA).|||participants|||Number
2683852|NCT01372618|Secondary|Hyperglycemia|In our previous study, we found that women had moderately increased blood sugar early after starting SOM230. In other studies in normal individuals this effect disappeared by a week or two. We found some evidence of improvement during administration. However, extending the treatment period from 9.5 to 19.5 days will enable us to make certain that the early elevated sugar associated with SOM230 is only temporary.|Before and after 20 days of treatment with 3 month post-treatment follow-up|PI death. Study terminated||||||
2683853|NCT01372618|Secondary|Effect of SOM 230 / Pasireotide on Tumor Volume and Tumor Kinetics|To determine whether pasireotide prevents angiogenesis in DCIS as it does in the rat mammary gland, we will immunostain tissue samples for Factor VIII to identify vessels in DCIS before and after treatment. Further, using dynamic contrast enhanced MRI (DCE-MRI) we plan to detect changes in angiogenesis in vivo, non-invasively, and also detect effects of pasireotide which theoretically should inhibit vascularity. We propose to evaluate changes in the size of the lesion, changes in the morphologic appearance and kinetic features of the lesion.|Before and after 20 days of treatment|PI death. Study terminated||||||
2683854|NCT01372618|Primary|Cell Proliferation and Apoptosis|Tissue from initial diagnostic breast biopsies will be compared to the remaining tissue excised after treatment with SOM230. Tissue will be stained to measure cell proliferation and apoptosis (cell death).|Before and after 20 days of treatment|PI death. Study terminated||||||
2683855|NCT01372605|Secondary|Depression-free Days|Total depression-free days over 12 months as calculated from Hamilton Rating Scale for Depression scores at baseline and 3, 6, 9, and 12 months|12 months|All participants with at least one depression measure contributed to this analysis.|||days||Standard Deviation|Mean
2683856|NCT01372605|Secondary|Safety Endpoint|Psychiatric hospitalizations|12 months||||participants|||Number
2683857|NCT01372605|Secondary|Self-reported Adherence|Antiretroviral medication adherence, self-reported, over past 30 days using a visual analog scale. On the scale, participants report the percentage of prescribed antiretroviral pills that were taken in the past 30 days, ranging from 0 (no pills) to 100% (all pills).|12 months|All participants completing the 12-month interview contributed data to this analysis. Some participants did not complete the 12-month interview but still completed the study and contributed other data.|||units on a scale||Standard Deviation|Mean
2693260|NCT01296360|Secondary|GMTs and Rate of Subjects With a PRNT Titer of >1:10 at Months 12, 24 and 36 After First IXIARO Vaccination in IC51-323 With and Without Booster Vaccination||36 months|||||||
2683858|NCT01372605|Secondary|Self Reported Adherence|Antiretroviral medication adherence, self-reported, over past 30 days using a visual analog scale. On the scale, participants report the percentage of prescribed antiretroviral pills that were taken in the past 30 days, ranging from 0 (no pills) to 100% (all pills).|6 months|All participants completing the 6-month interview and currently on antiretrovirals contributed to this analysis. Some participants did not complete the 6-month interview but still continued in the study and contributed to later data.|||units on a scale||Standard Deviation|Mean
2683859|NCT01372605|Secondary|Quality of Life|Short Form-12 Mental Composite score. Scores range from 0-100, with 50 corresponding to the mean and 10 points to the standard deviation in a normative US population. Higher scores indicate better health.|6 months|All participants who completed a 6-month research interview contributed data to this endpoint. Some participants did not complete the 6-month interview but still continued in the study and contributed later data.|||units on a scale||Standard Deviation|Mean
2683860|NCT01372605|Secondary|Number of Participants With Viral Load Below Detection|HIV RNA viral load below the limit of detection at 6 months|6 months|All participants with a viral load available at 6 months. Some individuals without a viral load at 6 months still continued in the study and provided later data.|||participants|||Number
2683861|NCT01372605|Secondary|Appointment Adherence|Kept HIV appointments as a percentage of all kept or missed appointments during 12 months post-enrollment|12 months|All participants with available medical chart data on appointment attendance were analyzed. Some participants did not complete the study but still contributed chart abstraction data.|||Percent of appts that were kept||Standard Deviation|Mean
2683862|NCT01372605|Secondary|Health Care Costs|Total health care costs over 12 months|12 months|All participants were analyzed using all available time points, with multiple imputation used to address missing data.|||dollars||Standard Error|Mean
2683863|NCT01372605|Secondary|Antiretroviral Medication Adherence|Antiretroviral medication adherence assessed by unannounced pill count, assessed by blinded assessor|12 months|Includes all individuals who completed a 6-month pill count that could be linked to an earlier (usually, 5-month) pill count, so as to calculate adherence. Some individuals did not complete this data point but still continued in the study and contributed later data.|||Percentage of expected pills||Standard Deviation|Mean
2683864|NCT01372605|Secondary|Depressive Symptoms|Hamilton Rating Scale for Depression (HAMD) symptom score at 6 months, assessed by blinded assessor. Possible score ranges from 0 to 50. Higher scores indicate worse depressive symptoms.|Six months|All those completing a 6-month outcomes interview which resulted in a valid HAMD measure|||units on a scale||Standard Deviation|Mean
2683865|NCT01372605|Primary|Antiretroviral Medication Adherence|Antiretroviral medication adherence assessed by monthly unannounced pill count, assessed by blinded assessor|Six months post-enrollment|All those completing a 6-month pill count which resulted in a valid adherence measure|||observed pills taken as % of expected||Standard Deviation|Mean
2683866|NCT01372501|Secondary|Change in Absolute Weight Loss From Baseline to Week 52||Week 52|Per Protocol Population (n=14); subjects who had the device implanted for 52 weeks.|||kg||Standard Deviation|Mean
2683867|NCT01372501|Primary|Assessment of the % Excess Weight Loss at Week 52 or Last Assessment|Excess weight was determined from ideal body weights based on a BMI of 25 kg/m2|52 Weeks|Full Analysis Set (FAS) population had a device successfully implanted.|||%EWL||Standard Deviation|Mean
2683868|NCT01372462|Secondary|Borg Dyspnea Score During Constant Workrate Exercise at Isotime|"Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control) at isotime. Borg Dyspnea Score ranges in values from 0 to 10. The lower score represent better outcome.~0 = No breathlessness at all, representing better outcome 10 = Maximum breathlessness, representing worse outcome"|Outcome was measured in each Study day 1,2,3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and N|Per Protocol|||units on a scale||Standard Deviation|Mean
2683869|NCT01372462|Secondary|SpO2 During Constant Workrate Exercise at Isotime|Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).|Outcome was measured in each of the Study day 1,2, 3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxyg|Per Protocol|||percentage of oxyHb saturation||Standard Deviation|Mean
2683870|NCT01372462|Primary|Exercise Duration for Constant Work Rate Exercise Tests Under 4 Test Conditions|Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).|Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen.|Per protocol analysis|||minutes||Standard Deviation|Mean
2683871|NCT01372410|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 8 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 8 is defined as the value obtained 24 hours after the morning dose administered on Day 7. Analysis was performed using a mixed model with covariates of mean Baseline, period Baseline, treatment, and period as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each particiapant. Change from Baseline for each treatment period is the trough FEV1 at Day 8 minus the Baseline value for that treatment period.|Baseline and Day 8 of each treatment period (up to Study Day 50)|mITT Population. All participants with >=1 post-baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 8.|||Liters||Standard Error|Least Squares Mean
2683935|NCT01371825|Secondary|Change From Baseline To Months 12, 24, 36, 48, And 60 In Serum Transaminases (ALT And AST)|Change from Baseline to Months 12, 24, 36, 48, and 60 for alanine aminotransferase (ALT) and aspartate aminotransferase (AST).|Baseline, Month 12, Month 24, Month 36, Month 48, and Month 60|The PES included participants who received any amount of sebelipase alfa and who were ≤8 months of age on the date of their first infusion of sebelipase alfa. All 9 participants were included in the PES.|||units/Liter (U/L)||Full Range|Median
2683872|NCT01372410|Primary|Final Dose-response Model Parameter β-FEV1MB-S0 for Trough FEV1|The trough FEV1 data for both the once-daily (QD) and twice-daily (BID) UMEC doses were included in a parametric analysis in order to evaluate dose response. Both a Day 8 dataset and a pooled dataset for Day 7 and Day 8 were analyzed and reported. The rationale for pooling Day 7 and Day 8 (post-hoc analysis) was to ensure informative interpretation of FEV1 response as a function of dose given the repeated measures for trough FEV1 response within each participant on different days. β-FEV1MB-S0 is defined as the covariate (Baseline trough FEV1) effect on the mean Baseline trough FEV1 estimate (S0). FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.|Day 7 and Day 8 of each treatment period (up to Study Day 50)|mITT Population: par. randomized to treatment who received >=1 dose of study medication. Par. with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X in category titles); the overall number of par. analyzed reflects everyone in the mITT Population.|||fraction of mean estimated Baseline FEV1|||Number
2683873|NCT01372410|Primary|Final Dose-response Model for Trough FEV1 for ED50 (Potency) Parameter|The trough FEV1 data for both the once-daily (QD) and twice-daily (BID) UMEC doses were included in a parametric analysis in order to evaluate dose response. Both a Day 8 dataset and a pooled dataset for Day 7 and Day 8 were analyzed and reported. The rationale for pooling Day 7 and Day 8 (post-hoc analysis) was to ensure informative interpretation of FEV1 response as a function of dose given the repeated measures for trough FEV1 response within each participant on different days. ED50 is defined as the potency and is the dose that yields 50% of Emax (maximum predicted FEV1 response). FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.|Day 7 and Day 8 of each treatment period (up to Study Day 50)|mITT Population: par. randomized to treatment who received >=1 dose of study medication. Par. with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X in category titles); the overall number of par. analyzed reflects everyone in the mITT Population.|||micrograms||95% Confidence Interval|Geometric Mean
2683874|NCT01372410|Secondary|Change From Baseline (BL) in Weighted Mean FEV1 Over 0 to 24 Hours After the Morning Dosing on Day 7 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The weighted mean FEV1 was calculated using 0-24 hour post-dose measurements at Day 7 of each treatment period, which included pre-dose and post-dose 1, 3, 6, 9, 12, 13, 15, 23, and 24 hours. Analysis was performed using a mixed model with covariates of mean BL, period BL, treatment, and period as fixed effects and participant as a random effect. BL is the FEV1 value recorded pre-dose on Day 1 of each TP, mean BL is the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the weighted mean FEV1 at Day 7 minus the BL value for that TP.|Baseline and Day 7 of each treatment period (TP; up to Study Day 49)|mITT Population. All participants with >=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 7.|||Liters||Standard Error|Least Squares Mean
2683875|NCT01372410|Secondary|Change From Baseline (BL) in Serial FEV1 Over Time on Day 7 of Each Treatment Period|Serial FEV1 for once daily dosing is recorded at the pre-AM dose (AMD; time 0 hour [h]) and at 1, 3, 6, 9, 12,13, 15, 23, and 24 hours after the AMD on Day 7. For twice daily dosing, the 12 h AMD corresponds to the pre-PM dose (PMD), the 13 h AMD corresponds to the 1 h PMD, the 15 h AMD corresponds to the 3 h PMD, the 23 h AMD corresponds to the 11 h PMD, and the 24 h AMD corresponds to the 12 h PMD in this table. Analysis was performed using a mixed model with covariates of mean BL, period BL, treatment, period, time, time by period BL interaction, time by mean BL interaction, and time by treatment interaction as fixed effects and participant as a random effect. BL is the value recorded pre-dose on Day 1 of each TP, mean BLis the mean of the BLs for each participant, and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each timepoint within a TP is the serial FEV1 measure at that timepoint minus the BL value for that TP.|Baseline and Day 7 of each treatment period (TP; up to Study Day 49)|mITT Population. All participants (par.) with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X, X, X, X in the category titles), so the overall number of par. analyzed reflects everyone in the mITT Population with data available at >=1 time point.|||Liters||Standard Error|Least Squares Mean
2683876|NCT01372410|Primary|Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1)|The trough FEV1 data for both the once-daily (QD) and twice-daily (BID) UMEC doses were included in a parametric analysis in order to evaluate trough FEV1dose response. The Day 8 dataset and a pooled dataset for Day 7 and Day 8 were analyzed separately and reported. The rationale for pooling Day 7 and Day 8 (post-hoc analysis) was to ensure informative interpretation of FEV1 response as a function of dose given the repeated measures for trough FEV1 response within each participant on different days. The fixed-effects parameters of the dose response model include Emax (the maximum predicted FEV1 response), ED50 (potency), and S0 (estimated Baseline FEV1). FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Data for Emax and S0 are reported in this table. mITT=Modified Intent-to-Treat; par.=participants; BL=Baseline.|Day 7 and Day 8 of each treatment period (up to Study Day 50)|mITT Population: par. randomized to treatment who received >=1 dose of study medication. Par. with >=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X in category titles); the overall number of par. analyzed reflects everyone in the mITT Population.|||Liters||95% Confidence Interval|Geometric Mean
2683877|NCT01372384|Secondary|Overall Survival|The overall survival (OS) is defined as the time from the first dose of Erlotinib to the date of death due to any cause.|Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.|The ITT population included all patients with at least one valid post-baseline assessment.|||Days||Full Range|Median
2684090|NCT01370564|Secondary|Estimate Changes in Clinical Markers of Heart Failure and Kidney Function|Changes in blood urea nitrogen from baseline to study exit (an average of 3-months).|Baseline through Completion/Exit (an average of 3-months)|Subjects with blood urea nitrogen values at both the baseline and study exit visits|||mg/dL||Standard Deviation|Mean
2683878|NCT01372384|Secondary|Safety: Incidence of Adverse Events|An AE is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An SAE is any experience that suggests a significant hazard, contraindication, side effect, or precaution.|Until participants had disease progression, unacceptable toxicity, or died; approximately 24 months.|All participants who received at least one dose of study medication and had a safety assessment performed post baseline were included in the safety population. Participants were analyzed according to the first dose received during the study.|||participants|||Number
2683879|NCT01372384|Secondary|Objective Response Rate (Investigator Assessed)|Objective response rate (ORR) was defined by RECIST criteria: Partial response (PR) was defined as ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) was defined as disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression of disease (PD) = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions. Stable Disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on the study.|Visit 4, Visit 6, Visit 10 and Visit 22; (up to approximately 24 months)|The ITT population included all patients with at least one valid post-baseline assessment. Only those participants available at the specified time points were analyzed (represented by n=X).|||Percentage||95% Confidence Interval|Number
2683880|NCT01372384|Primary|Progression-free Survival (Tumour Assessments According to RECIST Criteria)|Progression free survival is (PFS) defined as the time from the first dose of Erlotinib to the date of first occurrence of disease progression or death.|Until participants had disease progression, unacceptable toxicity or died; approximately 24 months.|The Intent-to-treat (ITT population) included all patients with at least one valid post-baseline assessment.|||Days||Inter-Quartile Range|Median
2683881|NCT01372202|Secondary|Esophageal Tumor CHFR Methylation and Detection in Plasma|To determine the agreement between tumor CHFR methylation and detection in plasma.|3 years|Study closed due to early stopping rule, therefore data was not collected to assess this outcome measure.||||||
2683882|NCT01372202|Secondary|Time to Disease Progression|To determine time to disease progression with this treatment strategy.|3 years|Study closed due to early stopping rule, therefore data was not collected to assess this outcome measure.||||||
2683883|NCT01372202|Secondary|Survival|Overall survival with given treatment strategy.|3 years||||Participants|||Count of Participants
2683884|NCT01372202|Primary|Pathological Complete Response|CHFR methylation status correlates with response to taxane containing platinum-based combination therapy and tumor response involving operable Esophageal Cancer. Perform analysis comparing detection of CHFR in tumor and plasma.|3 years||||Participants|||Count of Participants
2683885|NCT01372150|Secondary|Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Weeks 1, 2, 3, 4, 6, and 8|ITT Population|||Percentage of Participants|||Number
2683886|NCT01372150|Secondary|Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Baseline and Weeks 1, 2, 3, 4, 6, and 8|ITT Population|||Percentage of Participants|||Number
2683887|NCT01372150|Secondary|Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score|A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.|Baseline and Week 8|ITT Population|||Score on a Scale||Standard Error|Mean
2683888|NCT01372150|Primary|Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score|Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.|Baseline and Week 8|Intention-To-Treat (ITT) Population - included all randomized participants who received at least 1 dose of study drug, had a baseline primary efficacy assessment, and had at least one post-baseline primary efficacy assessment.|||Score on a Scale||Standard Error|Mean
2683889|NCT01372085|Secondary|Part B: Average Time-Matched QT Interval Corrected by Fridericia's Formula (QTcF) Change From Baseline to Day 1|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using Fridericia's formula: QTcF = QT/RR^0.33. The QTcF after single oral doses of LY2584702 test formulation [TF (tablet)], LY2584702 reference formulation [RF (capsule)], or placebo were administered in a fasted or fed state are reported at baseline (time-matched Day -1 QTcF) and 3 hours (h), 4 h, 6 h, and 24 h postdose. Day 1, Hour 24 was time-matched with Day-1, Hour 0.|Part B: Baseline [Period 1 (Day -1)] and Periods 1 to 4 (Day 1). Electrocardiograms (ECG) were performed at time point 0 and 3 h, 4 h, 6 h, and 24 h.|Randomized participants in Part B of the study who had both baseline and postdose ECG assessments at each time point.|||milliseconds (ms)||Standard Deviation|Mean
2683949|NCT01371747|Secondary|Proportion of Participants Achieving Serum Potassium Levels Within 3.5 to 5.5 mEq/L at Week 8 for Each Individual Starting Dose Group||Baseline to Week 8|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.|||percentage of participants||95% Confidence Interval|Number
2683890|NCT01372085|Secondary|Part A: QT Interval Corrected by Fridericia's Formula (QTcF) Change From Baseline to Day 1|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and is calculated from electrocardiogram (ECG) data. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between 2 R waves. Using Fridericia's formula: QTcF = QT/RR^0.33. The QTcF after single oral doses of LY2584702 reference formulation [RF (capsule)] were administered in a fasted state are reported at baseline (Day 1, Predose) and 3 hours (h), 4 h, 6 h, and 24 h postdose.|Part A: Baseline [Day 1 (Predose)] and Day 1 (3 h, 4 h, 6 h, and 24 h postdose)|Randomized participants in Part A of the study who had both baseline and postdose ECG assessments at each time point. Data was not collected for Placebo group due to insufficient participants (N=2).|||milliseconds (ms)||Standard Deviation|Mean
2683891|NCT01372085|Secondary|Part B: Baseline-Adjusted Change-From-Predose in the Concentration of Lipids (Total Cholesterol)|Baseline-adjusted change-from-predose in lipid concentrations were measured to assess the LY2584702 effect on lipids under different fed states. The 50-milligram (mg) LY2584702 test formulation [TF (tablet)] was the only dose and formulation administered in both the fasted and fed states for comparison. Therefore, changes in total cholesterol after single oral doses of placebo, 10-mg, or 200-mg LY2584702 TF or 25-mg or 50-mg LY2584702 reference formulation [RF (capsule)] were not calculated. The baseline-adjusted change-from-predose in total cholesterol levels in the fasted and fed state following a single 50-mg LY2584702 TF dose is reported. Baseline was Day -1 of Period 1 for Period 3 fasted state and baseline was Day -1 of Period 4a for Period 4a fed state. Least squares (LS) means was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, time, treatment by time, and participant.|Part B: Baseline [Periods 1 and 4a (Day -1)], Periods 3, 4a (Day 1). Lipid concentration measurements were performed at time point 0 and 1 hour (h), 3 h, 4 h, 6 h, 10 h, and 24 h.|Randomized participants (pts) in Part B of study who had both baseline and postdose total cholesterol measurements. Pts not analyzed for baseline-adjusted change-from-predose total cholesterol levels after single dose placebo, 10-mg, or 200-mg LY2584702 TF or 25-mg or 50-mg LY2584702 RF since they weren’t administered in both fasted and fed state.|||milligrams per deciliter (mg/dL)||90% Confidence Interval|Least Squares Mean
2683892|NCT01372085|Secondary|Pharmacokinetics, Area Under the Concentration-Time Curve (AUC)|AUC from time 0 to the time of the last quantifiable concentration [AUC(0-tlast)] and AUC from time 0 to infinity [AUC(0-inf)] following a single oral dose of LY2584702 test formulation [TF (tablet)] or reference formulation [RF (capsule)] is reported.|Part A: Day 1 and Part B: Periods 1 to 4, Day 1 [Predose, 1 hour (h), 3 h, 4 h, 6 h, 10 h, 24 h, 48 h postdose]|Randomized participants in Part A or B of the study who had evaluable AUC data.|||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2683893|NCT01372085|Primary|Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax)|The Cmax following a single oral dose of LY2584702 test formulation [TF (tablet)] or reference formulation [RF (capsule)] is reported.|Part A: Day 1 and Part B: Periods 1 to 4, Day 1 [Predose, 1 hour (h), 3 h, 4 h, 6 h, 10 h, 24 h, 48 h postdose]|Randomized participants in Part A or B of the study who had evaluable Cmax data.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2683894|NCT01371994|Secondary|Time From Baseline to First Day of Returning to Work|The time from Baseline to first day of returning to work was estimated using the Kaplan-Meier method.|From Baseline to Week 12|Full analysis set participants who were employed prior to the study.|||days||95% Confidence Interval|Median
2683895|NCT01371994|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant's assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.|Baseline and Week 12|"Full analysis set with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point."|||Percent activity impairment||Standard Error|Least Squares Mean
2683896|NCT01371994|Secondary|Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent activity impairment is derived from the participant's assessment of the degree to which their urinary leakage affected their regular daily activities. A higher percentage indicates greater impairment and less productivity.|Baseline|Full analysis set participants with available WPAI data at Baseline.|||percent activity impairment||Standard Deviation|Mean
2683897|NCT01371994|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.|Baseline and Week 12|"Full analysis set including participants who were employed prior to the study and with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point."|||percent overall work impairment||Standard Error|Least Squares Mean
2683898|NCT01371994|Secondary|Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent overall work impairment takes into account both hours missed due to urinary leakage and the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity.|Baseline|Full analysis set participants who were employed prior to the study and with available WPAI data at Baseline.|||percent overall work impairment||Standard Deviation|Mean
2683899|NCT01371994|Secondary|Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity. A negative change from Baseline indicates improvement.|Baseline and Week 12|"Full analysis set including participants who were employed prior to the study and with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point."|||percent impairment while working||Standard Error|Least Squares Mean
2683900|NCT01371994|Secondary|Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent impairment while working was derived from the participant's assessment of the degree to which urinary leakage affected their productivity while working. A higher percentage indicates greater impairment and less productivity.|Baseline|Full analysis set participants who were employed prior to the study and with available WPAI data at Baseline.|||percent impairment while working||Standard Deviation|Mean
2683901|NCT01371994|Secondary|Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. A negative change from Baseline indicates improvement.|Baseline and Week 12|"Full analysis set including participants who were employed prior to the study and with available WPAI data at both Baseline and each time point; n indicates the number of participants with available data at each time point."|||Percent work time missed||Standard Error|Least Squares Mean
2683902|NCT01371994|Secondary|Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed|Work productivity was measured by the Work Productivity and Activity Impairment Questionnaire (WPAI). WPAI asks participants about the effect of urinary leakage on their ability to perform their work-related functions and carry out daily activities over the past seven days. Percent work time missed is derived from the number of hours of work missed due to urinary leakage as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed.|Baseline|Full analysis set participants who were employed prior to the study and with available WPAI data at Baseline.|||percent work time missed||Standard Deviation|Mean
2683903|NCT01371994|Secondary|Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score|The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother).|Baseline and Week 12|"Full analysis set with available ICIQ-SF data at both Baseline and each time point; n indicates the number of participants with available data at each time point."|||units on a scale||Standard Error|Least Squares Mean
2683904|NCT01371994|Secondary|International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline|The ICIQ-SF is a validated self-administered questionnaire designed for patients with urinary incontinence. The ICIQ-SF assessed urinary incontinence using 3 scored questions which ask patients about their frequency of urine leakage, how much urine leakage, and perceived impact of leakage on daily lives over the past 4 weeks. The ICIQ-SF is a sum of the 3 scores and ranges from 0 (low bother) to 21 (maximum bother).|Baseline|Full analysis set with available ICIQ-SF QOL data at Baseline.|||units on a scale||Standard Deviation|Mean
2683905|NCT01371994|Secondary|Change From Baseline in American Urology Association Quality of Life (QOL) Score|"The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible).~End of treatment is the last on-treatment assessment during the treatment period."|Baseline and Week 12|"Full analysis set with available AUA data at both Baseline and each time point; n indicates the number of participants with available data at each time point."|||units on a scale||Standard Error|Least Squares Mean
2683906|NCT01371994|Secondary|American Urology Association Quality of Life (QOL) Score at Baseline|The American Urology Association (AUA) includes a single bother question which asked participants how they would feel if they had to live with their urinary condition the way it is now for the rest of their life. The bother question score ranges from 0 (delighted) to 6 (terrible).|Baseline|Full analysis set with available AUA QOL data at Baseline.|||units on a scale||Standard Deviation|Mean
2683907|NCT01371994|Secondary|Change From Baseline in American Urology Association Symptom Score (AUASS)|"Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always).~The AUASS Symptom Score is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst).~End of treatment is the last on-treatment assessment during the treatment period."|Baseline and Week 12|"Full analysis set with available AUASS data at both Baseline and each time point; n indicates the number of participants with available data at each time point."|||units on a scale||Standard Error|Least Squares Mean
2683950|NCT01371747|Secondary|Mean Change in Serum Potassium From Week 52 or Last Patiromer Dose (if Occurred Before Week 52) to Follow-up Visits Plus 7 Days||Week 52 or Last Patiromer Dose (if Occurred before Week 52) to Following up Visit Plus 7 Days|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.|||mEq/L||Standard Deviation|Mean
2683908|NCT01371994|Secondary|American Urology Association Symptom Score (AUASS) at Baseline|"Quality of life was measured by the American Urology Association Symptom Score (AUASS). The AUASS includes 7 questions addressing symptoms of frequency, urgency, nocturia (waking during the night to urinate), hesitancy, weak urinary, incomplete emptying, and intermittence. The questionnaire asked participants to consider how these symptoms affected them over the past month on a scale from 0 (not at all) to 5 (almost always).~The AUASS is a sum of the 7 symptom scores and ranges from 0 (best) to 35 (worst)."|Baseline|Full analysis set with available AUASS data at Baseline.|||units on a scale||Standard Deviation|Mean
2683909|NCT01371994|Secondary|Change From Baseline in Average Daily Pad Usage|"Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage.~End of treatment is the last on-treatment assessment during the treatment period."|Baseline and Weeks 4, 8 and 12|"Full analysis set with available pad usage data at both Baseline and each time point; n indicates the number of participants with available data at each time point."|||pads||Standard Error|Least Squares Mean
2683910|NCT01371994|Secondary|Average Daily Pad Usage at Baseline|Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period. A 7-day window was used to calculate the average daily pad usage.|Baseline (7 days prior to Day 1)|Full analysis set with available pad usage data at Baseline.|||pads||Standard Deviation|Mean
2683911|NCT01371994|Secondary|Percentage of Participants Who Gain Continence During 12-week Treatment Period|"Urinary continence is defined as three consecutive 24-hour days in which a participant uses no pads or a pad for security which remains completely dry. Participants recorded their daily pad usage in an electronic diary during the 12-week treatment period.~End of treatment is the last on-treatment assessment during the treatment period."|Weeks 4, 8, and 12|Full analysis set; the calculation of percentage of participants uses the full analysis set as the denominator at each time point.|||percentage of participants|||Number
2683912|NCT01371994|Primary|Time From First Dose to Urinary Continence|Urinary continence is defined as the first of three consecutive 24-hour days in which a participant uses no pads, or a pad for security which remains completely dry, during the 12-week treatment period. Participants recorded their daily pad usage in an electronic diary. Kaplan-Meier curves were used to estimate the distribution of cumulative incidence of urinary continence over the 12-week study treatment period. Participants who did not experience the event during the 12-week treatment period were considered as censored at the End of Treatment (EOT) visit or Week 12, whichever occurs first.|12 weeks|Full analysis set defined as all randomized participants who took at least one dose of study drug and had at least one efficacy endpoint evaluation.|||days||95% Confidence Interval|Median
2683913|NCT01371877|Secondary|Number of Participants With Adverse Events|Unit of Measure is Safety and Tolerability. The number of participants with adverse events will be compared between the groups using the independent sample t-test (assuming the distribution is normal).|3 month study trial|No significant adverse events. All subjects in the high vitamin D3 group completed the study; 4 subjects in the low vitamin D3 600 IU/day withdrew from the study (1 for pregnancy and 3 unknown). There was no evidence of hypercalcemia.|||participants|||Number
2683914|NCT01371877|Secondary|Total Urticaria Severity Score at 3 Months|The Unit of Measure is Efficacy. The Total Urticaria Severity Score (USS) ranges from 0 to 93, higher scores = worse symptoms. This secondary outcome of this study is to determine if high dose vitamin D supplementation improves the urticaria severity score (USS). The change in USS will be compared between the groups using the independent sample t-test (assuming the distribution is normal). Logistic regression and multiple linear regression will be used to adjust for possible confounders.|3 month intervention||||units on a scale||Standard Error|Mean
2683915|NCT01371877|Primary|Medication Usage|The Unit of Measure is Efficacy. The primary outcome of this study is to determine if vitamin D supplementation reduces the medication usage in subjects with CUA. Thus, for the outcome of reduction in pills, at 12 weeks, subjects whose pill usage decreases by 2 or more pills per day will be classified as improved. Subjects whose pill consumption did not change or increased will be classified as unchanged.|12 week intervention||||number of pills/day||Standard Deviation|Mean
2683916|NCT01371851|Primary|Change in Psychostimulant-positive Urines Over Time|Urine samples positive for methamphetamine or cocaine via twice-weekly urine drug screens. Weekly urine results data were averaged within subjects and the mean proportion across subjects within each group was calculated for graphic representation.|twice-weekly urine samples (8 weeks)|Those eligible participants who received at least one dose of study medication.|||proportion of psychostimulant-pos urines|Participants|Standard Deviation|Mean
2683917|NCT01371838|Secondary|Microbiological Re-infection/Recurrence at LFU Visit in ME Population||21-42 days after last dose of study drug|ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations|||Participants|||Number
2683918|NCT01371838|Secondary|Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population||21-42 days after last dose of study drug|mMITT population: All subjects in MITT population who meet the minimal disease criteria for CABP and who have at least one typical bacterial organism consistent with a CABP pathogen identified from an appropriate microbiological specimen (eg, blood, sputum, or pleural fluid).|||Participants|||Number
2683919|NCT01371838|Secondary|Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in CE Population||21-42 days after last day of study drug administration|CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient’s outcome (ie, the patient does not have an indeterminate outcome). For this measure only patients who were cured at TOC could be assessed for relapse.|||Participants|||Number
2683920|NCT01371838|Secondary|Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in MITT Population||21-42 days after last day of study drug administration|All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV. For this measure only patients who were cured at TOC could be assessed for relapse.|||Participants|||Number
2683921|NCT01371838|Secondary|Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in CE Population||7-20 days after last dose of study drug|CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient’s outcome (ie, the patient does not have an indeterminate outcome).|||Participants|||Number
2683923|NCT01371838|Secondary|Per-Patient Microbiological Response at Test of Cure (TOC) Visit in ME Population|An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid.|7-20 days after last day of study drug administration|ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations.|||Participants|||Number
2683924|NCT01371838|Secondary|Per-Patient Microbiological Response at Test of Cure (TOC) Visit in mMITT Population|An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid.|7-20 days after last day of study drug administration|mMITT population: All subjects in MITT population who meet the minimal disease criteria for CABP and who have at least one typical bacterial organism consistent with a CABP pathogen identified from an appropriate microbiological specimen (eg, blood, sputum, or pleural fluid).|||Participants|||Number
2683925|NCT01371838|Secondary|Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population||7-20 days after last dose of study drug|ME population: includes patients who meet criteria for both the CE and mMITT populations. In fact, there were different pathogens isolated and we decided to focus on the 5 ones that occurred the most. Additionally please be informed that patients number will not match even if we present all 18 pathogens due to polymicrobial infections.|||Participants|||Number
2683926|NCT01371838|Secondary|Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population||7-20 days after last dose of study drug|ME population: includes patients who meet criteria for both the CE and mMITT populations. In fact, there were different pathogens isolated and we decided to focus on the 5 ones that occurred the most. Additionally please be informed that patients number will not match even if we present all 18 pathogens due to polymicrobial infections.|||Participants|||Number
2683927|NCT01371838|Secondary|Clinical Response at the Test of Cure (TOC) Visit in ME Population||7-20 days after last day of study drug administration|ME population: The ME population includes patients who meet criteria for both the CE and mMITT populations.|||Participants|||Number
2683928|NCT01371838|Secondary|Clinical Response at the Test of Cure (TOC) Visit in mMITT Population||7-20 days after last day of study drug administration|mMITT population: All subjects in MITT population who meet the minimal disease criteria for CABP and who have at least one typical bacterial organism consistent with a CABP pathogen identified from an appropriate microbiological specimen (eg, blood, sputum, or pleural fluid).|||Participants|||Number
2683929|NCT01371838|Secondary|Clinical Response at the Test of Cure (TOC) Visit in MITT Population||7-20 days after last day of study drug administration|All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV.|||Participants|||Number
2683930|NCT01371838|Secondary|Clinical Response at End of Treatment (EOT) Visit in CE Population||Last day of study drug administration|CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient’s outcome (ie, the patient does not have an indeterminate outcome).|||Participants|||Number
2683931|NCT01371838|Secondary|Clinical Response at End of Treatment (EOT) Visit in MITT Population||Last day of study drug administration|All randomized subjects who were intended to receive study treatment and were of PORT risk class III and IV.|||Participants|||Number
2683932|NCT01371838|Primary|Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population|Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: •Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy •Treatment-limiting AE leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia •Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome|7-20 days after last dose of study drug|CE population: All patients in the MITT population who also meet the minimal disease criteria for CABP and for whom sufficient information regarding CABP is available to determine the patient’s outcome (ie, the patient does not have an indeterminate outcome).|||Participants|||Number
2683933|NCT01371825|Secondary|Number Of Participants Achieving And Maintaining Transfusion-free Hemoglobin Normalization [TFHN]|"The number of participants achieving and maintaining TFHN are presented.~For TFHN to be achieved, the participant must a) have had 2 post-baseline measurements of hemoglobin at least 4 weeks apart that were both above the age-adjusted lower limit of normal; b) have had no known additional measurements of hemoglobin that were below the age-adjusted lower limit of normal during the (minimum) 4-week period; and c) have had no transfusions during the (minimum) 4-week period, and also no transfusions for 2 weeks prior to the first hemoglobin measurement in the (minimum) 4-week period.~For TFHN to be maintained, the participant must have been transfusion-free beginning at Week 6 and had all hemoglobin assessments above the lower limit of normal beginning in Week 8 and lasting at least 13 weeks."|Baseline to Month 60|Participants in the PES who received treatment with sebelipase alfa for at least 4 weeks (and could therefore be assessed for short-term TFHN). The PES included participants who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa.|||Participants|||Count of Participants
2683934|NCT01371825|Secondary|Change From Baseline To Months 12, 24, 36, 48, And 60 In Serum Ferritin|The median change in serum ferritin from Baseline to Months 12, 24, 36, 48, and 60 is presented.|Baseline, Month 12, Month 24, Month 36, Month 48, and Month 60|The PES included participants who received any amount of sebelipase alfa and who were ≤8 months of age on the date of their first infusion of sebelipase alfa. All 9 participants were included in the PES.|||micrograms/Liter (µg/L)||Full Range|Median
2685197|NCT01361633|Secondary|Logical Memory Subtests|Measures verbal memory recall|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up|||||||
2683936|NCT01371825|Secondary|Number Of Participants With Stunting, Wasting, Or Underweight|"The number of participants who met criteria for the following dichotomous indicators of under nutrition were reported. These indicators included the following:~Stunting was defined as at least 2 standard deviations below the median for length-for-age/height-for-age;~Wasting was defined as wasting at least 2 standard deviations below the median for weight-for-length/weight-for-height; and~Underweight was defined as at least 2 standard deviations below the median for WFA."|Baseline to Month 12, Month 24, Month 36, Month 48, and Month 60|The PES included participants who received any amount of sebelipase alfa and who were ≤8 months of age on the date of their first infusion of sebelipase alfa. All 9 participants were included in the PES.|||Participants|||Count of Participants
2683937|NCT01371825|Secondary|Change From Baseline To Months 12, 24, 36, 48, And 60 In Weight For Age (WFA) Percentiles|Baseline is defined as the last measurement prior to the first infusion of sebelipase alfa.|Baseline, Month 12, Month 24, Month 36, Month 48, and Month 60|The PES included participants who received any amount of sebelipase alfa and who were ≤8 months of age on the date of their first infusion of sebelipase alfa. All 9 participants were included in the PES.|||WFA Percentile||Full Range|Median
2683938|NCT01371825|Secondary|Median Age At Death|Participants in the PES who died during the study, including 3 participants who died after having received between 1 and 4 infusions of sebelipase alfa and 1 participant who died after approximately 40 weeks on treatment.|Baseline to Week 260|Participants in the PES who died during the study were included in this analysis. The PES included all 9 participants who received any amount of sebelipase alfa and who were ≤8 months of age on the date of their first infusion of sebelipase alfa.|||months||Full Range|Median
2683939|NCT01371825|Secondary|Percentage Of Participants Surviving Beyond 12 Months Of Age|The percentage of participants in the PES who survived to at least 18 months of age.|Baseline to Month 18, Month 24, Month 36, Month 48, and Month 60|Evaluable participants in the PES, which included participants who received any amount of sebelipase alfa and who were ≤ 8 months of age on the date of their first infusion of sebelipase alfa. There were 2 non-evaluable participants at Month 60, defined as participants who were alive, still in the study, and had not yet reached 60 months of age.|||Percentage of participants||95% Confidence Interval|Number
2683940|NCT01371825|Primary|Percentage Of Participants In The Primary Efficacy Analysis Set (PES) Surviving To 12 Months Of Age|The primary efficacy endpoint was the percentage of participants (%) in the PES who survived to at least 12 months of age.|Month 12|The PES included participants who received any amount of sebelipase alfa and who were ≤8 months of age on the date of their first infusion of sebelipase alfa. All 9 participants were included in the PES.|||Percentage of participants||95% Confidence Interval|Number
2683941|NCT01371786|Secondary|Deposition of Radioactivity Within on Nasal Wipes Over 10 Minutes as a Percent of Delivered Dose|The scintigraphic measure of radioactivity deposited on nasal wipes, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), over 10 minutes (at approximately 2 minute intervals post-dose) following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Average of 2, 4, 6, 8, and 10 minutes post dose|Scinitigraphic Population|||percentage of radiolabeled||Standard Deviation|Mean
2683942|NCT01371786|Secondary|Initial Deposition of Radioactivity on Nasal Wipes as a Percent of Delivered Dose|The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) on nasal wipes, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Day 1 at 2 minutes post-dose|Scintigraphic Population|||percentage of radiolabeled||Standard Deviation|Mean
2683943|NCT01371786|Secondary|Deposition of Radioactivity Within the Nasal Cavity Over 10 Minutes as a Percent of Delivered Dose|The scintigraphic measure of radioactivity deposited within the nasal cavity, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), over 10 minutes (at approximately 2 minute intervals post-dose) following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Average of 2, 4, 6, 8 and 10 minutes post dose|Scinitgraphic Population|||percentage of of radiolabled||Standard Deviation|Mean
2683944|NCT01371786|Secondary|Initial Deposition of Radioactivity Within the Nasopharynx as a Percent of Delivered Dose|The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) within the nasopharynx, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Day 1 at 2 minutes post-dose|Scintigraphic Population|||percentage of radiolabeled||Standard Deviation|Mean
2683945|NCT01371786|Primary|Initial Deposition of Radioactivity Within the Nasal Cavity as a Percent of Delivered Dose|The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) within the nasal cavity, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.|Day 1 at 2 minutes post dose|Scintigraphic Population|||percentage of radiolabeled||Standard Deviation|Mean
2683946|NCT01371747|Secondary|Proportions of Participants Achieving Serum Potassium Levels Within 3.8 to 5.0 mEq/L at Week 52 for Each Individual Starting Dose Group||Baseline to Week 52|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.|||percentage of participants||95% Confidence Interval|Number
2683947|NCT01371747|Secondary|Time to First Serum Potassium Measurement of 4.0 - 5.0 mEq/L During Treatment Initiation Period for Each Individual Starting Dose Group||Baseline to Week 8|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.|||Days||95% Confidence Interval|Median
2683948|NCT01371747|Secondary|Proportion of Participants Achieving Serum Potassium Levels Within 4.0 to 5.0 mEq/L at Week 8 for Each Individual Starting Dose Group||Baseline to Week 8|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.|||percentage of participants||95% Confidence Interval|Number
2683951|NCT01371747|Secondary|Mean Change in Serum Potassium From Baseline to Week 52 During the Long-term Maintenance Period for Each Individual Starting Dose Group||Baseline to Week 52|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.|||mEq/L||Standard Deviation|Mean
2683952|NCT01371747|Secondary|Least Squares Mean Change in Serum Potassium From Baseline to Day 3 During the Treatment Initiation Period for Each Individual Starting Dose Group|Least squares mean changes from Baseline to Day 3 were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates.|Baseline to Day 3|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.|||mEq/L||Standard Error|Least Squares Mean
2683953|NCT01371747|Secondary|Least Squares Mean Change in Serum Potassium From Baseline to Week 8 or Time of First Titration for Each Individual Starting Dose Group|Least squares mean changes from Baseline to Week 8/first titration were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates.|Baseline to Week 8 or First Titration which could occur at any scheduled study visit after patiromer initiation.|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.|||mEq/L||Standard Error|Least Squares Mean
2683954|NCT01371747|Primary|Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group|Least square mean changes from Baseline to Week 4/first titration were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates.|Baseline to Week 4 or First Titration which could occur at any scheduled study visit after patiromer initiation.|Included all randomized participants who received at least 1 dose of patiromer. Analyses of endpoints included participants with available central laboratory potassium values at the time point of interest.|||mEq/L||Standard Error|Least Squares Mean
2683955|NCT01371734|Secondary|Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. Higher score = more affected.|Weeks 1, 2, 3, 4, 6, and 8|ITT Population n is the number of participants with non-missing values|||Percentage of Participants|||Number
2683956|NCT01371734|Secondary|Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score equals (=) more affected.|Weeks 1, 2, 3, 4, 6, and 8|ITT Population n is the number of participants with non-missing values|||Percentage of Participants|||Number
2683957|NCT01371734|Secondary|Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)|A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Mean change from baseline was adjusted for the baseline total score, age group and gender.|Baseline and Week 8|ITT Population n is the number of participants with evaluable data.|||Score on a scale||Standard Error|Least Squares Mean
2683958|NCT01371734|Primary|Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)|Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Mean change from baseline was adjusted for the baseline total score, age group and gender.|Baseline and Week 8|"Intention-To-Treat (ITT) Population - included all randomized participants who received at least 1 dose of study drug, had a baseline primary efficacy assessment, and had at least one post-baseline primary efficacy assessment.~n is the number of participants with evaluable data."|||Score on a scale||Standard Error|Least Squares Mean
2683959|NCT01371721|Secondary|Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.|||Percentage of Participants|||Number
2683960|NCT01371721|Primary|Percentage of Participants Experiencing a Treatment Emergent Adverse Event||Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|Safety Population-includes all treatment-assigned participants who took at least one dose of investigational product in the period of study B2061031.|||Percentage of Participants|||Number
2683961|NCT01371721|Secondary|Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases|Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.|||Percentage of Participants|||Number
2685198|NCT01361633|Secondary|Controlled Oral Word Association Test|Measure of a person's ability to make verbal associations to specified letters.|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up|||||||
2683962|NCT01371721|Secondary|Percentage of Participants With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26|A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Higher score = more affected.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.|||Percentage of Participants|||Number
2683963|NCT01371721|Secondary|Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases|A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.|||Score on a Scale||Standard Deviation|Mean
2683964|NCT01371721|Secondary|Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases|Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.|Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study|ITT-included all randomized participants who had a baseline (of study B2061031) CDRS-R evaluation (Week 9 of study B2061014) took at least 1 dose of study drug and had at least 1 CDRS-R evaluation after the first dose of study drug in the B2061031 study period.|||Score on a Scale||Standard Deviation|Mean
2683965|NCT01371708|Secondary|Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group)|Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.|||Percentage of participants|||Number
2683966|NCT01371708|Secondary|Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases|Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.|||Percentage of participants|||Number
2683967|NCT01371708|Secondary|Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)|"The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing very much improved and 7 representing very much worse; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032."|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.|||Percentage of participants|||Number
2683968|NCT01371708|Secondary|Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases|"The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing very much improved and 7 representing very much worse; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032."|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.|||Percentage of participants|||Number
2683976|NCT01371708|Primary|Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)|A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who received at least 1 dose of study drug in study B2061030|||Percentage of participants|||Number
2683977|NCT01371656|Secondary|Comparison of the Percentage of Patients Having Incidence of CDAD Between Arms|Clostridium Difficile Associated Disease (CDAD) is defined as a positive C. difficile toxin assay result and diarrhea, CTCAE version 4, grade 2 and higher.|Up to 60 days after enrollment or receiving levofloxacin|All evaluable, and centrally reviewed AL and HSCT patients are reported. Ineligible patients and patients who withdrew of consent prior to treatment were excluded.|||Percentage of patients|||Number
2683969|NCT01371708|Secondary|Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group)|"The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing very much improved and 7 representing very much worse; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032."|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.|||Percentage of participants|||Number
2683970|NCT01371708|Secondary|Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases|"The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing very much improved and 7 representing very much worse; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032."|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.|||Percentage of participants|||Number
2683971|NCT01371708|Secondary|Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)|"The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating normal, not at all ill and 7, among the most extremely ill patients. Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032."|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.|||Units on a scale||Standard Deviation|Mean
2683972|NCT01371708|Secondary|Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases|"The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating normal, not at all ill and 7, among the most extremely ill patients. Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032."|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a Children's Depression Rating Scale-Revised (CDRS-R) evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.|||Units on a scale||Standard Deviation|Mean
2683973|NCT01371708|Secondary|Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)|The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.|||Units on a scale||Standard Deviation|Mean
2683974|NCT01371708|Secondary|Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases|The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.|||Units on a scale||Standard Deviation|Mean
2683975|NCT01371708|Primary|Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)|A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.|From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030|All participants who received at least 1 dose of study drug in study B2061030|||Percentage of participants|||Number
2683978|NCT01371656|Secondary|Comparison of the Percentage of Patients Having Incidence of Musculoskeletal Adverse Events Including Tendinopathy (Tendonitis and Tendon Rupture) Between Arms|Musculoskeletal conditions included at least one occurrence of arthralgia, arthritis, gait abnormality or tendinopathy.|Enrollment, 2 months and 12 months post infection observation period|Evaluable patients who submitted musculoskeletal Case Record Form (CRF) combined from both Acute Leukemia (AL) and Hematopoietic stem cell transplantation (HSCT) cohorts at enrollment. Ineligible and withdrew of Consent prior to treatment were excluded.|||Percentage of patients|||Number
2683979|NCT01371656|Secondary|Comparison of the Percentage of Patients That Died Due to Bacterial Infection Between Arms||Up to 60 days after enrollment or receiving levofloxacin|Evaluable patients combined from both AL and HSCT cohorts were reported. Ineligible and withdrew of Consent prior to Tx were excluded.|||Percentage of patients|||Number
2683980|NCT01371656|Secondary|Comparison of the Percentage of Patients Having Severe Infection Between Arms|Severe infection defined as any grade 4 or 5 CTCAE catheter-related infection, enterocolitis, lung infection, sepsis, small intestine infection and other infections or infestations|Up to 60 days after enrollment or receiving levofloxacin|All evaluable, and centrally reviewed AL and HSCT patients are reported. Ineligible patients and patients who withdrew of consent prior to treatment were excluded.|||Percentage of patients|||Number
2683981|NCT01371656|Secondary|Comparison of the Percentage of Patients Having Incidence of Fever and Febrile Neutropenia Between Arms|Fever and febrile neutropenia defined as Absolute Neutrophil Count (ANC) < 1000/mm3 with a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >= 38 degrees C (100.4 degrees F) for more than one hour.|Up to 60 days after enrollment or receiving levofloxacin|All evaluable, and centrally reviewed AL and HSCT patients are reported. Ineligible patients and patients who withdrew of consent prior to treatment were excluded.|||Percentage of patients|||Number
2683982|NCT01371656|Secondary|Comparison of the Percentage of Patients Having Antibiotic Exposures Between Arms|Exposure to antibiotics was considered during the infection observation period(s) was defined a priori as follows: Gram positive agents = vancomycin, linezolid, daptomycin or quinupristin/dalfopristin; Aminoglycosides = amikacin, gentamicin or tobramycin; Third or fourth generation cephalosporins = cefepime, ceftazidime, ceftriaxone or cefotaxime; Empiric antibiotics for fever and neutropenia = imipenem, meropenem, cefepime, ceftazidime or piperacillin/tazobactam|Up to 60 days after enrollment or receiving levofloxacin|All evaluable, and centrally reviewed AL and HSCT patients are reported. Ineligible patients and patients who withdrew of consent prior to treatment were excluded.|||Percentage of patients|||Number
2683983|NCT01371656|Primary|Comparison of the Percentage of Patients Having Bacteremia Incidence Between Levofloxacin vs. No Prophylaxis Arms|A bacteremia incidence is defined as an occurrence of at least 1 episode of true (centrally reviewed) bacteremia among Acute Leukemia (AL) and Hematopoietic stem cell transplantation (HSCT) patients.|Up to 60 days after enrollment or receiving levofloxacin|All evaluable, and centrally reviewed AL and HSCT patients are reported. Ineligible patients and patients who withdrew of consent prior to treatment were excluded.|||Percentage of patients|||Number
2683984|NCT01371643|Secondary|Percentage of Responders (Only Including Surgical Failures in Arm 2)|Nadir growth hormone <1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.|3 months||||percentage of participants||95% Confidence Interval|Number
2683985|NCT01371643|Primary|Percentage of Responders (All Treatments)|Nadir growth hormone <1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.|3 months||||percentage of participants||95% Confidence Interval|Number
2683986|NCT01371643|Primary|Percentage of Responders (Primary Medical Treatment in Arm 1, Primary Surgical Treatment in Arm 2)|Nadir growth hormone <1 ng/mL during a standard 2 hour oral glucose tolerance test using 75 g glucose and normal IGF-I according to age and gender-matched standards.|3 months||||percentage of participants||95% Confidence Interval|Number
2683987|NCT01371565|Primary|Number of Participants With Adverse Events|Safety was assessed at all visits and adverse events were recorded.|6 months|Due to the small number of patients enrolled (N=4), no formal assessments were planned. All patients who received study drug were included in the safety review.|||participants|||Number
2683988|NCT01371552|Primary|"Percentage of Participants Responding Yes"|The participant responded to 11 subjective, performance-related statements on a questionnaire by circling 1 = yes, 2 = no, or 3 = don't know.|Part 2: Day 7|This reporting group includes all participants who completed Part 2.|||Percentage of participants|||Number
2683989|NCT01371552|Primary|Lens Wettability|Lens wettability was assessed by the investigator during slit-lamp examination and graded on a 0-4 scale in 0.25 steps, where 0 = excellent and 4 = severely reduced.|Part 1: Day 1 at Dispense, Day 1 at 8 hours, Day 3 at 8 hours|This reporting group includes all participants who completed all three lens wear periods in Part 1.|||Units on a scale||Standard Deviation|Mean
2683990|NCT01371552|Primary|Percentage of Participants Preferring Study Lens Either Strongly or Slightly (of Those With a Preference) vs. Their Habitual Lenses at End of Wear|"The participant circled a number from 1 to 5 in response to the question, Overall, which lens do you prefer - the lens you wore today or your regular lenses? in which 1 = strongly prefer my regular lenses, 2 = prefer my regular lenses, 3 = no preference, 4 = prefer test lens, 5 = strongly prefer test lens. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 3|This reporting group includes all participants who completed all three lens wear periods in Part 1.|||Percentage of participants|||Number
2683991|NCT01371552|Primary|Percentage of Participants Reporting That Their Eyes Rarely or Never Felt Dry at End of Wear|"The participant circled a number from 0 to 4 in response to the question, Over the entire day while wearing these contact lenses, how often did your eyes feel dry? in which 0 = never, 1 = rarely, 2 = sometimes, 3 = frequently, 4 = constantly. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 2|This reporting group includes all participants who completed all three lens wear periods in Part 1.|||Percentage of participants|||Number
2683992|NCT01371552|Primary|Mean Overall Ease of Handling at End of Wear|"The participant recorded a number from 0 to 100 in response to the question, How would you rate the overall ease of handling these lenses? in which 0 = very difficult and 100 = very easy. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 3|This reporting group includes all participants who completed all three lens wear periods in Part 1.|||Units on a scale||Standard Deviation|Mean
2683993|NCT01371552|Primary|Mean Overall Quality of Vision at End of Wear|"The participant recorded a number from 0 to 100 in response to the question, How would you rate the overall quality of vision while wearing these lenses? in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 3|This reporting group includes all participants who completed all three lens wear periods in Part 1.|||Units on a scale||Standard Deviation|Mean
2683994|NCT01371552|Primary|Mean Overall Comfort Given at End of Wear|"The participant recorded a number from 0 to 100 in response to the question, How would you rate the overall comfort of these lenses? in which 0 = very poor and 100 = excellent. The end of wear questionnaire was completed at time of lens removal for that day."|Part 1: Day 3|This reporting group includes all participants who completed all three lens wear periods in Part 1.|||Units on a scale||Standard Deviation|Mean
2683995|NCT01371552|Primary|Mean Value of Comfort During the Day|"The participant recorded a number from 0 to 100 in response to the question, How would you rate the comfort of your lenses over the last hour? in which 0 = very poor and 100 = excellent. Comfort was assessed at 4 hours, 8 hours, and 12 hours, and the responses were averaged."|Part 1: Day 2 at 4 hours, 8 hours, and 12 hours|This reporting group includes all participants who completed 12 hours of lens wear on Day 2.|||Units on a scale||Standard Deviation|Mean
2683996|NCT01371539|Primary|Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity|The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.|1 week|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.|||logMAR||Standard Deviation|Mean
2683997|NCT01371539|Primary|Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity|The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.|1 week|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.|||logMAR||Standard Deviation|Mean
2683998|NCT01371305|Secondary|Number of Participants With Treatment Emergent Antibodies to BG00011||Up to Week 19|The “Safety” population consisted of all participants who received at least one dose of BG00011 or placebo.|||participants|||Number
2683999|NCT01371305|Secondary|Percentage Change (PC) From Baseline in Biomarkers Isolated From Bronchoalveolar Lavage (BAL)|The expression level of 7 genes; Arachidonate 5-lipoxygenase (ALOX5), fibronectin 1 (FN1), Oxidized low density lipoprotein receptor 1 (OLR1), Plasminogen activator inhibitor-1 (PAI-1; aka SERPINE 1), Transglutaminase 2 (TGM2), Triggering receptor expressed on myeloid cells 1 (TREM1), and v-ets erythroblastosis virus E26 oncogene homolog 1 (ETS1) were assessed via BAL as well as a ratio of pSMAD2 to tSMAD2 levels.|Baseline, Day 8 (Follow up)|The “Pharmacodynamic” population consisted of all participants who received at least 1 multiple dose injection of BG00011 and have a corresponding sample collected for BAL and/or blood biomarkers.|||Percentage||Standard Deviation|Mean
2684000|NCT01371305|Secondary|Apparent Volume of Distribution (Vd/F) of BG00011||Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50|PK population = safety population. Data for this outcome measure was not analysed on day 1.|||milliliter per kilogram (mL/kg)||Standard Deviation|Mean
2684001|NCT01371305|Secondary|Apparent Clearance (CL/F) of BG00011||Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50|PK population = Safety population. Data for this outcome measure was not collected at Day 1.|||milliliter/hour/kilogram (mL/hr/kg)||Standard Deviation|Mean
2684002|NCT01371305|Secondary|Area Under the Concentration Versus Time Curve From Time Zero to Infinity AUC(0-inf) of BG00011||Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50|PK population = Safety population. Data for this outcome measure was not collected at Day 1.|||hr*ng/mL||Standard Deviation|Mean
2684003|NCT01371305|Secondary|Apparent Terminal Rate Constant [λz]||Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50|PK population = Safety population. Data for this outcome measure was not collected at Day 1.|||hour||Standard Deviation|Mean
2684004|NCT01371305|Secondary|Apparent Terminal Elimination Half Life (T1/2) of BG00011||Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50|PK population = Safety population. Data for this outcome measure was not collected at Day 1.|||hour||Standard Deviation|Mean
2684005|NCT01371305|Secondary|Area Under the Serum Concentration-Time Curve From Time 0 to 168 Hours AUC(0-168) of BG00011||Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50|PK population = Safety population.|||hr*ng/mL||Standard Deviation|Mean
2684006|NCT01371305|Secondary|Area Under the Serum Concentration Time Curve From Time 0 to Last Quantifiable Observed Concentration AUC(0-t) of BG00011||Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50|PK population = Safety population.|||hours nanogram per milliliter (hr*ng/mL)||Standard Deviation|Mean
2684007|NCT01371305|Secondary|Maximum Observed Serum Concentration (Cmax) of BG00011||Pre-dose, 8, 24, 48 and 96 hours post-dose on Day 1; pre-dose on Days 8, 15, 22, 29, 36, 43; pre-dose, 24, 48, 96, 168, 336, 504, 672, 1344, 2016 hours post-dose on Day 50|PK population = Safety population.|||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
2684009|NCT01371305|Primary|Number of Participants With Adverse Events (AEs)|An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.|up to Week 19|The “Safety” population consisted of all participants who received at least one dose of BG00011 or placebo.|||Participants|||Number
2684010|NCT01371110|Secondary|Percentage of Patients Who Meet Response and Remission|Percentage of patients who meet response (defined as 25% reduction in Y-BOCCS score) and remission (defined as Y-BOCS score ≤10) criteria at 24 hrs post-infusion and durability of efficacy up to two weeks after administration. Assessments will be performed 24, 48 and 72 hrs post-infusion and after 7, 10, and 14 days.|up to 14 days||||percentage of participants|||Number
2684011|NCT01371110|Primary|Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCCS) Rating OCD Symptom Severity From Baseline to 24-hours After Ketamine Administration|"The primary efficacy outcome is change in the Y-BOCCS rating score on a scale from baseline to 24 hrs post-administration of ketamine.~The 10 Y-BOCCS items are each scored on a four-point scale from 0 = no symptoms to 4 = extreme symptoms. The sum of the first five items is a severity index for obsessions. The sum of the last five an index for compulsions. A translation of total score into an approximate index of overall severity is: 0-7 - subclinical; 8-15 - mild; 16-23 - moderate; 24-31 - severe; 32-40 - extreme."|Baseline and 24 Hours||||Units on a scale||Full Range|Mean
2684012|NCT01371006|Secondary|Group B - Number of Participants With Drug Related Adverse Events|"Number of participants with investigator-defined drug related adverse events (AE) in sequence group B. AEs occurring up to 5 days after last intake of Faldaprevir were assigned to Faldaprevir+Midazolam+Efavirenz treatment.~AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone."|From Day 1 up to 30 days after last treatment (Days 1,2,6,8,9,10,11,14,17,18,19,24)|all subjects entered in sequence group B of the treated set.|||participants|||Number
2684013|NCT01371006|Secondary|Group A - Number of Participants With Drug Related Adverse Events|"Number of participants with investigator-defined drug related adverse events (AE) in sequence group A. AEs occurring up to 5 days after last intake of Faldaprevir on day 19 were assigned to Efavirenz+Faldaprevir treatment.~AEs were assessed throughout the trial. During the outpatient portion of the trial, assessment of AEs was monitored by telephone."|From Day 1 up to 30 days after last treatment (Days 1,2,3,4,5,6,7,8,11,13,14,15,16,17,18,19,20,24)|all subjects entered in sequence group A of the treated set.|||participants|||Number
2684014|NCT01371006|Secondary|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG|Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Physical Examination and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.|From first treatment administration (Day 1) up to Day 24|treated set: All subjects who were dispensed study medication and were documented to have taken at least 1 dose of trial medication|||participants|||Number
2684015|NCT01371006|Secondary|Group B - Midazolam: AUC0-∞|Area under the concentration-time curve of of Midazolam over the time interval 0 to infinity on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam|all subjects entered in sequence group B of the PK set.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2684016|NCT01371006|Secondary|Group B - Midazolam: Tmax|Time of maximum concentration after a single dose of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam|all subjects entered in sequence group B of the PK set.|||hours||Full Range|Median
2684017|NCT01371006|Secondary|Group B - Midazolam: Cmax|Maximum plasma concentration of Midazolam on days 1, 9 and 18, calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 14:00, 24:00 h after administration of Midazolam|all subjects entered in sequence group B of the PK set.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2684018|NCT01371006|Secondary|Group B - Faldaprevir: Tmax,ss|Time of maximum concentration of Faldaprevir on Day 9 and 10 at steady state, calculated for patients in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence group B of the PK set|||hours||Full Range|Median
2684019|NCT01371006|Secondary|Group A - Efavirenz: Tmax|Time of maximum concentration of Efavirenz on day 14, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Efavirenz|All patients entered in sequence group A of the PK set|||hours||Full Range|Median
2684020|NCT01371006|Secondary|Group A - Faldaprevir: C12,ss|Plasma concentration 12 h after dosing of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence group A of the PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2684021|NCT01371006|Secondary|Group A - Faldaprevir: AUC0-12h,ss|Area under the concentration-time curve of Faldaprevir over the time interval 0-12h on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence group A of the PK set|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2684022|NCT01371006|Secondary|Group A - Faldaprevir: Tmax,ss|Time of maximum concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence sequence group A of the PK set|||hours||Full Range|Median
2684023|NCT01371006|Secondary|Group A - Faldaprevir: Cmax,ss|Maximum plasma concentration of Faldaprevir on day 14 at steady state, calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after administration of Faldaprevir|All patients entered in sequence group A of the PK set|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2697164|NCT01263717|Secondary|Carotid Intimal Medial Thickness (cIMT)|Carotid Intimal Medial Thickness (cIMT).|6 months|All available data were used.|||Change in mm||95% Confidence Interval|Mean
2684024|NCT01371006|Primary|Group B - Faldaprevir: C12,ss|Plasma concentration 12 h after dosing of Faldaprevir at steady state calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir|all subjects entered in sequence group B of the PK set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2684025|NCT01371006|Primary|Group B - Faldaprevir: AUC0-12h,ss|Area under the concentration-time curve of Faldaprevir at steady state over the time interval 0 to 12h calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir|all subjects entered in sequence group B of the PK set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2684026|NCT01371006|Primary|Group B - Faldaprevir: Cmax,ss|Maximum plasma concentration at steady state of Faldaprevir calculated for subjects in sequence group B (600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00 h after first administration of Faldaprevir|all subjects entered in sequence group B of the PK set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2684027|NCT01371006|Primary|Group A - Efavirenz: AUC0-∞|Area under the concentration-time curve of the analyte in plasma over the time interval 0 to infinity of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 h after administration of Efavirenz|all subjects entered in sequence group A of the PK set.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2684028|NCT01371006|Primary|Group A - Efavirenz: Cmax|Maximum plasma concentration (Cmax) of Efavirenz calculated for subjects in sequence group A (240 mg Faldaprevir+50 mg Efavirenz)|0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00 hours(h) after administration of Efavirenz|all subjects entered in sequence group A of the PK set. Pharmacokinetic (PK) set: This subject set included all subjects of the treated set who provided evaluable data for at least1 observation for at least 1 primary PK endpoint in any trial period without important protocol violations.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2684029|NCT01370863|Secondary|Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Questionnaire at 4 Weeks|The PAGI-SYM contains 20 items and the scores range from 0 (no symptoms)-5 (very severe symptoms) for each item with a total score of 0-100. Higher scores indicate more severe gastrointestinal symptoms.|Baseline and 4 weeks|Pharmacodynamics Population (PD) defined as all randomized subjects with at least 1 administration of the investigational product and with both a baseline and post-baseline PD assessment.|||Units on a scale||Standard Deviation|Mean
2684030|NCT01370863|Secondary|Change From Baseline in the Number of Days With Heartburn and/or Regurgitation at 4 Weeks||Baseline and 4 weeks|Pharmacodynamics Population (PD) defined as all randomized subjects with at least 1 administration of the investigational product and with both a baseline and post-baseline PD assessment.|||Number of days||Standard Deviation|Mean
2684031|NCT01370863|Primary|Change From Baseline in the Number of Liquid-containing Reflux Events (pH/MII Monitoring) at 4 Weeks|This is used to characterize gastric reflux events. The measurements were made over a 24-hour period at baseline and again at week 4.|Baseline and 4 weeks|Pharmacodynamics Population (PD) defined as all randomized subjects with at least 1 administration of the investigational product and with both a baseline and post-baseline PD assessment.|||Number of Reflux Events||Standard Deviation|Mean
2684032|NCT01370837|Primary|Induration Size as a Response to Intracutaneous Candida Albicans.||48 hours after injection.||||millimeters||95% Confidence Interval|Median
2684033|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Remission at Week 6 or Early Termination (Per Protocol - Non-Naive Subjects)|"The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. All subjects in the Per Protocol population completed Week 6. This analysis includes only PP subjects exposed to an antidepressant medication in their current episode (non-naive).~This outcome provides the total number of subjects in each arm that achieved clinical remission at Week 6 within the Non-Naive, Per Protocol population.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population - Non-Naive Subjects|||participants|||Number
2684034|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Remission at Week 6 (Per Protocol - All)|"For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. All subjects in the Per Protocol population completed Week 6.~This outcome provides the total number of subjects in each arm that achieved clinical remission within the Per Protocol population at Week 6.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (up to week 6)|Per Protocol Population|||participants|||Number
2684052|NCT01370655|Primary|Percentage of Participants Who Experienced at Least 1 Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced an AE during the study was summarized by study drug taken at the time of the AE.|Up to 14 days post last dose of each treatment period (total of 6 weeks for each treatment period)|All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence.|||Percentage of Participants|||Number
2684035|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Remission at Week 6 or Early Termination (Intent to Treat)|"The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical remission. Remission is defined as a total HAM-D17 score ≤ 7. If any subject did not complete the double-blind phase (Week 6) in the Intent to Treat (ITT) population, the assessment last observation carried forward (LOCF) was used.~This outcome provides the total number of subjects in each arm that achieved clinical remission within the ITT population.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)|Includes all subjects who signed an informed consent, met all I/E criteria, were subsequently randomized and received at least 1 treatment (active sTMS or sham) session in the double-blind phase.|||participants|||Number
2684036|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - Non-Naive Subjects)|"The Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response, defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. All subjects in the Per Protocol (PP) population completed Week 6. This analysis includes only PP subjects exposed to an antidepressant medication in their current episode (non-naive).~This outcome provides the total number of subjects in each arm that achieved clinical response within the Non-Naive, Per Protocol population.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population - Non-Naive Subjects|||participants|||Number
2684037|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Response at Week 6 (Per Protocol - All)|"For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response. Response is defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. All subjects in the Per Protocol population completed Week 6.~This outcome provides the total number of subjects in each arm that achieved clinical response within the Per Protocol population.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population|||participants|||Number
2684038|NCT01370733|Secondary|Number of Subjects Who Demonstrate Clinical Response at Week 6 or Early Termination (Intent to Treat)|"For this outcome, the Hamilton Rating Scale for Depression (HAM-D17) was utilized to determine clinical response. Response is defined as a reduction of at least 50% in total HAM-D17 score from Baseline through Week 6. If any subject did not complete the double-blind phase (Week 6) in the ITT population, the assessment last observation carried forward (LOCF) was used.~This outcome provides the total number of subjects in each arm that achieved clinical response within the Intent to Treat population.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity."|Baseline to End of Double-Blind Treatment Period (Week 6)||||participants|||Number
2684039|NCT01370733|Secondary|Mean HAM-D17 Total Score Change (Per Protocol - Non-Naive Subjects)|"All subjects in the Per Protocol analysis completed Week 6. Baseline HAM-D17 total score was directly compared to Week 6 HAM-D17 total score. The single value provided in each arm reflects this change.~This analysis included only Per Protocol subjects exposed to an antidepressant medication in their current episode (non-naive). This includes past history of intolerance, resistance, or inadequate dosing/duration.~The Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population - Non-Naive Subjects|||units on a scale||Standard Deviation|Mean
2684040|NCT01370733|Primary|Mean HAM-D17 Total Score Change (Per Protocol - All)|"The mean HAM-D17 total score change from Baseline (Day 0) to Week 6 compared between the active treatment and sham-controlled groups. All subjects in the Per Protocol analysis completed Week 6. Baseline HAM-D17 total score was directly compared to the HAM-D17 total score at Week 6. The single value provided in each arm reflects the change seen.~For this trial, the Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response."|Baseline to End of Double-Blind Treatment Period (Week 6)|Per Protocol Population|||units on a scale||Standard Deviation|Mean
2684064|NCT01370629|Secondary|Number of Participants Who Are Converted to Sinus Rhythm for at Least One Minute||Up to 90 minutes after the start (baseline) of first infusion of vernakalant||||Participants|||Count of Participants
2684065|NCT01370629|Primary|Number of Participants Experiencing Significant Bradycardia||Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion||||Participants|||Count of Participants
2684041|NCT01370733|Primary|Mean HAM-D17 Total Score Change (Intent to Treat - All)|"The mean HAM-D17 total score change from Baseline (Day 0) to Week 6 compared between the active treatment and sham-controlled groups. If any subject did not complete the double-blind phase in the ITT population, the assessment last observation carried forward (LOCF) was used. The single value provided in each arm reflects the change seen.~For this trial, the Hamilton Rating Scale for Depression (HAM-D28) was performed as a baseline assessment. A subset of the HAM-D28, the HAM-D17, was utilized as both a baseline and efficacy measure. It's considered the gold standard for rating depression severity and used frequently in clinical trials. The HAM-D17 score ranges from 0-52; a score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity. A reduction of 50% or more in total score from Baseline indicates clinical response."|Baseline to End of Double-Blind Treatment Period (Week 6)|Includes all subjects who signed an informed consent, met all I/E criteria, were subsequently randomized and received at least 1 treatment (active sTMS or sham) session in the double-blind phase.|||units on a scale||Standard Deviation|Mean
2684042|NCT01370694|Secondary|Clinical Response of Tumor to MK-8808/CVP Combination Therapy|The response of the tumor to MK-8808/CVP combination therapy was radiographically assessed using Response Criteria Evaluation in Solid Tumors (RECIST). Response categories of partial response (PR), complete resonse (CR), and uncomfirmed (CRu) central review.|Up to 2 years|All participants with evaluable data|||Participants|||Number
2684043|NCT01370694|Secondary|Ctrough of Plasma Levels of MK-8808 When Used as Single Agent Maintenance|Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.|Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)|No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.||||||
2684044|NCT01370694|Secondary|Lowest Concentration (Ctrough) of Plasma Levels of MK-8808 When Used in Combination With CVP|Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.|Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)|This analysis was not done due to early termination of the study.||||||
2684045|NCT01370694|Secondary|Cmax of Plasma Levels of MK-8808 During Single Agent Maintenance Therapy|Cmax is a measure of the maximum amount of drug in the plasma over time using samples taken at specified time points.|Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)|No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.||||||
2684046|NCT01370694|Secondary|Maximum Concentration (Cmax) of Plasma Levels of MK-8808 When Used in Combination With CVP|Cmax is a measure of the maximum concentration of the drug in the plasma as measured using plasma samples taken over specified time points.|Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)|This analysis was not done due to early termination of the study.||||||
2684047|NCT01370694|Primary|Number of Participants Experiencing Clinical and Laboratory AEs During MK-8808 Maintenance Therapy|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose of single agent MK-8808 up to 2 years|No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.||||||
2684048|NCT01370694|Primary|Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.|From first dose of combination therapy up to 24 weeks|All participants receiving at least one dose of any study drug.|||Participants|||Number
2684049|NCT01370655|Secondary|Change From Baseline in Urine Potassium at 24 Hours Post-dose on Day 28|Urine potassium (K+) levels were measured over 24-hours on Day -1 and on Day 28. The total amount of K+ excreted in the urine for Day-1 (baseline) and Day 28 were calculated and the difference between the 2 values was recorded.|Baseline (Day -1) and Day 28|All participants who received at least 1 dose of study drug, complied with protocol sufficiently and had available data for endpoint. Participants are grouped by study drug taken at the time of the evaluation and not by randomly assigned sequence.|||mmol/day||90% Confidence Interval|Least Squares Mean
2684050|NCT01370655|Primary|Percentage of Participants Who Experienced at Least 1 Drug-related Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who experienced an AE that was reported as at least possibly-related to the study was summarized by study drug taken at the time of the AE.|Up to 14 days post last dose of each treatment period (total of 6 weeks for each treatment period)|All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence.|||Percentage of Participants|||Number
2684051|NCT01370655|Primary|Percentage of Participants Who Had Study Discontinued During the Study Due to an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the product, was also an AE. The percentage of participants who had the administration of the study drug discontinued during the study was summarized by study drug taken at the time of the AE. Participants may or may not have completed the study.|up to 4 weeks of each treatment period|All participants who received at least 1 dose of study drug. AEs are reported by study drug taken at the time of the event and not by randomly assigned sequence.|||Percentage of Participants|||Number
2684066|NCT01370629|Primary|Number of Participants Experiencing Significant Atrial Flutter||Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion||||Participants|||Count of Participants
2684067|NCT01370629|Primary|Number of Participants Experiencing Significant Ventricular Arrhythmia||Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion||||Participants|||Count of Participants
2684053|NCT01370655|Primary|Change From Baseline in Urine Sodium at 24 Hours Post-dose on Day 1|Urine sodium (Na) levels were measured over 24-hours on Day -1 (baseline) and on Day 1. The total amount of Na excreted in the urine for Day-1 (baseline) and Day1 were calculated and the difference between the 2 values was recorded.|Baseline (Day-1) and Day 1|All participants who received at least 1 dose of study drug, complied with protocol sufficiently and had available data for endpoint. Participants are grouped by study drug taken at the time of the evaluation and not by randomly assigned sequence.|||mmol/day||90% Confidence Interval|Least Squares Mean
2684054|NCT01370655|Primary|Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Diastolic Blood Pressure (DBP)|Each participant had their blood pressure monitored by continuous 24-hour ambulatory blood pressure monitoring (ABPM) on Days -1 and 28 of each treatment period. The average diastolic blood pressure over the 24-hour monitoring period was calculated for baseline (Day -1) and Day 28. The difference between baseline and Day 28 was calculated and recorded.|Baseline and Day 28|All participants who received at least 1 dose of study drug, complied with protocol sufficiently and had available data for endpoint. Participants are grouped by study drug taken at the time of the evaluation and not by randomly assigned sequence.|||mmHg||90% Confidence Interval|Least Squares Mean
2684055|NCT01370655|Primary|Change From Baseline in Time-weighted Average Over 24 Hours Post Dose (TWA [0-24]) in Systolic Blood Pressure (SBP)|Each participant had their blood pressure monitored by continuous 24-hour ambulatory blood pressure monitoring (ABPM) on Days -1 and 28 of each treatment period. The average systolic blood pressure over the 24-hour monitoring period was calculated for baseline (Day -1) and Day 28. The difference between baseline and Day 28 was calculated and recorded.|Baseline and Day 28|All participants who received at least 1 dose of study drug, complied with protocol sufficiently and had available data for endpoint. Participants are grouped by study drug taken at the time of the evaluation and not by randomly assigned sequence.|||mmHg||90% Confidence Interval|Least Squares Mean
2684056|NCT01370642|Primary|Percentage of Participants Who Discontinued Study Drug Due to an AE|An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience.|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment. One treated participant was excluded from the APaT due to a protocol violation.|||percentage of participants|||Number
2684057|NCT01370642|Secondary|Least Squares (LS) Mean Change From Baseline in HCV RNA (Log 10)|"HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered undetectable."|Baseline, Week 2, Week 4, Week 8, Week 12, Week 24|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.|||Log IU/ml||95% Confidence Interval|Least Squares Mean
2684058|NCT01370642|Primary|Percentage of Participants With One or More Tier 1 Adverse Events (AEs) During the Study|"An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience. For this study, safety parameters or AEs of special interest that were identified a priori constituted Tier 1 safety endpoints that were subject to inferential testing for statistical significance. Tier 1 AEs on this study included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal adverse (GI) experiences (vomiting, nausea, and diarrhea)."|From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)|All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment. One treated participant was excluded from the APaT due to a protocol violation.|||percentage of participants|||Number
2684059|NCT01370642|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)|Participants were assessed for undetectable HCV RNA levels at the end of all study therapy.|At Week 24 or 48|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.|||percentage of participants|||Number
2684060|NCT01370642|Secondary|Percentage of Participants Achieving Complete Early Virologic Response (cEVR)|cEVR was defined as having an undetectable HCV RNA level at Week 12.|At Week 12|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.|||percentage of participants|||Number
2684061|NCT01370642|Secondary|Percentage of Participants Achieving Rapid Virologic Response (RVR)|RVR was defined as having an undetectable HCV RNA level at Week 4.|At Week 4|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.|||percentage of participants|||Number
2684062|NCT01370642|Secondary|Percentage of Participants Achieving SVR12|SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy.|12 weeks after 24 or 48 weeks of study therapy (up to 60 weeks)|FAS population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.|||percentage of participants|||Number
2684063|NCT01370642|Primary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)|SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy.|24 weeks after 24 or 48 weeks of study therapy (up to 72 weeks)|Full Analysis Set (FAS) population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.|||percentage of participants|||Number
2684069|NCT01370616|Secondary|Percentage of Participants Who Discontinued Treatment Due to an AE|Participants chose to discontinue treatment or were discontinued from the study by the investigator due to any untoward effects, or for safety reasons such as an AE. The investigator determined whether or not the AE caused the test drug to be discontinued.|Up to day 28|Participants who received at least one dose of IV study therapy|||Percentage of participants|||Number
2684070|NCT01370616|Secondary|Percentage of Participants With Serious AEs (SAEs)|A SAE is an AE occurring at any dose that resulted in any of the following: death, was life threatening, a persistent or significant disability/incapacity, prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect in an offspring, was a cancer, an overdose, or other important medical events requiring medical or surgical intervention.|Up to day 42|Participants who received at least one dose of IV study therapy|||Percentage of participants|||Number
2684071|NCT01370616|Secondary|Percentage of Participants With Drug-related AEs|A drug-related AE is any AE caused by the test drug as determined by an investigator who is a qualified physician. Drug-relatedness of the AE was assessed by evidence that the participant was actually exposed to the test drug, whether the AE followed a reasonable temporal sequence from administration of the test drug, and whether or not the AE was more reasonably explained by another source.|Up to day 42|Participants who received at least one dose of IV study therapy|||Percentage of participants|||Number
2684072|NCT01370616|Secondary|Percentage of Participants With One or More Adverse Events (AEs)|An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body that is temporally associated with the use of the investigational product, whether or not considered related to the use of the medicinal product. This also includes any change in frequency and/or intensity of a preexisting condition which is temporally associated with the use of the medicinal product.|Up to day 42|Participants who received at least one dose of IV study therapy|||Percentage of participants|||Number
2684073|NCT01370616|Secondary|Percentage of Participants With Both Favorable Clinical and Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy|The investigator assessed participants for both a favorable clinical response (clinical improvement or cure) and a favorable microbiological response (eradication or presumptive eradication). Clinical improvement means that most pretherapy signs and symptoms of the index infection, had resolved, and no further IV antibiotic therapy is required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required. Eradication means that the original pathogen was absent from the last available culture obtained from the original site of infection. Presumptive eradication means that the participant showed cure or improvement and no appropriate material is available to follow-up culture from the original site of infection, or collection of such a specimen would cause undue discomfort.|Day 15 up to Day 38|Participants with proper clinical diagnosis, adequate study therapy and clinical assessment, appropriate antimicrobial therapy, and microbiological assessment. One participant from the Ertapenem arm with indeterminate clinical response, was excluded from the analysis. A modified LOCF (failure was carried forward), was used to impute missing data.|||Percentage of participants||95% Confidence Interval|Number
2684074|NCT01370616|Secondary|Percentage of Participants With Favorable Microbiological Response Assessments at FUA Day 10 of Post-antibiotic Study Therapy|The investigator assessed participants for a favorable microbiological response, defined as eradication or presumptive eradication. Eradication means that the original pathogen was absent from the last available culture of an adequate specimen obtained from the original site of infection. Presumptive eradication means that the participant showed cure or improvement and no appropriate material is available to follow-up culture from the original site of infection, or collection of such a specimen would cause undue discomfort.|Day 15 up to Day 38|Participants with proper clinical diagnosis, adequate study therapy, adequate clinical assessment, appropriate antimicrobial therapy, and proper microbiological assessment. A modified LOCF, where only failure was carried forward, was used to impute missing data.|||Percentage of participants||95% Confidence Interval|Number
2684075|NCT01370616|Secondary|Percentage of Participants With Favorable Clinical Response Assessments at Follow-up Assessment (FUA) Day 10 of Post-antibiotic Study Therapy|The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.|Day 15 up to Day 38|Participants with a confirmed clinical diagnosis, adequate length of IV study therapy, protocol-specified visit at FUA, and no documented protocol-specific exclusions. A modified LOCF, where only failure was carried forward, was used to impute missing data.|||Percentage of participants||95% Confidence Interval|Number
2684076|NCT01370616|Secondary|Percentage of Participants With Favorable Clinical Response Assessments at Day 5 of IV Study Therapy|The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.|Day 5|Participants with a confirmed clinical diagnosis, adequate length of IV study therapy, protocol-specified visit at Day 5, and no documented protocol-specific exclusions. A modified LOCF, where only failure was carried forward, was used to impute missing data.|||Percentage of participants||95% Confidence Interval|Number
2684077|NCT01370616|Primary|Percentage of Participants With Favorable Clinical Response Assessments at Discontinuation of Intravenous (IV) Study Therapy (DCIV)|The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.|Day 5 up to Day 28|Participants with confirmed clinical diagnosis, adequate IV study therapy, protocol-specified visit at DCIV, and no protocol-specific exclusions. A modified last-observation-carried-forward (LOCF), where only failure was carried forward, was used to impute missing data.|||Percentage of participants||95% Confidence Interval|Number
2684078|NCT01370603|Secondary|Percent Change From Baseline in Triglycerides (TG) After 6 Weeks of Treatment|Serum TG measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2684079|NCT01370603|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B After 6 Weeks of Treatment|Serum Apo B measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2684080|NCT01370603|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) After 6 Weeks of Treatment|Non-HDL-C calculated at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2684081|NCT01370603|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks of Treatment|Serum HDL-C measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2684082|NCT01370603|Secondary|Percent Change From Baseline in Total Cholesterol (TC) After 6 Weeks of Treatment|Serum TC measured at baseline and after 6 week of treatment in each of the 2 treatment periods.|Baseline and Week 6|"Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have~substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period."|||Percentage Change||95% Confidence Interval|Least Squares Mean
2684083|NCT01370603|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks of Treatment|Serum LDL-C calculated using Friedewald formula at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant may have been a protocol violator in 1 treatment period and not in the other treatment period.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2684084|NCT01370590|Secondary|Percent Change From Baseline in Triglycerides (TG) After 6 Weeks of Treatment|Serum TG measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2684085|NCT01370590|Secondary|Percent Change From Baseline in Apolipoprotein (Apo) B After 6 Weeks of Treatment|Serum Apo B measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2684086|NCT01370590|Secondary|Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) After 6 Weeks of Treatment|Non-HDL-C measured at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2684087|NCT01370590|Secondary|Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) After 6 Weeks of Treatment|Serum HDL-C calculated at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2684088|NCT01370590|Secondary|Percent Change From Baseline in Total Cholesterol (TC) After 6 Weeks of Treatment|Serum TC measured at baseline and after 6 week of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2684089|NCT01370590|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks of Treatment|Serum LDL-C calculated using Friedewald formula at baseline and after 6 weeks of treatment in each of the 2 treatment periods.|Baseline and Week 6|Per-Protocol Population, which excluded participants due to important deviations from the protocol that may have substantially affected the results of the primary efficacy endpoint(s). A participant could be excluded from 1 or more of the analyses. Results are reported by treatment formulation and not by sequence.|||Percentage Change||95% Confidence Interval|Least Squares Mean
2693261|NCT01296360|Secondary|GMTs (Geometric Mean Titre) for JEV Neutralizing Antibodies Measured Using a Validated PRNT (Plaque Reduction Neutralization Test) at 1 Month After the Booster Dose||1 month|||||||
2684091|NCT01370564|Secondary|Estimate Changes in Clinical Markers of Heart Failure and Kidney Function|Changes in estimated glomular filtration rate from baseline to study exit (an average of 3-months).|Baseline through Completion/Exit (an average of 3-months)|Subjects with lestimated glomular filtration rate values available at the baseline and study exit (3-month) visit.|||mL/min per 1.73 m^2||Standard Deviation|Mean
2684092|NCT01370564|Secondary|Summarize Adverse Events|All serious adverse events, cardiovascular adverse events, and event related to the IPC system will be documented and summarized.|Baseline through Completion/Exit (an average of 3-months)|All 21 subjects participating in the IPC study|||Participants|||Count of Participants
2684093|NCT01370564|Secondary|Estimate Changes in Clinical Markers of Heart Failure and Kidney Function|Changes in brain natriuretic peptide from baseline to study exit (an average of 3-months).|Baseline through Completion/Exit (an average of 3-months)|Subjects with brain natriuretic peptide values at baseline and study completion (3-month visit) visits|||pg/dL||Standard Deviation|Mean
2684094|NCT01370564|Secondary|Quantify Subject Compliance to Daily PtIS|The proporition of IPC days study subjects indicated they complied with their PtIS.|Baseline through Completion/Exit (on average 3-months)|The analysis population is the total number of study participants. For each study subject, the number of days in which the subject indicated that they followed their PtIS|||proportion of compliant days||95% Confidence Interval|Number
2684095|NCT01370564|Secondary|Characterize the Rate of IPC Setup System Changes|The frequency of changes in the IPC setup during the study (an average of 3-months).|Baseline through Completion/Exit (an average of 3-months)|The analysis population is the total number of study participants. For each study subject, the number of changes to the IPC setup were obtained|||changes per day||95% Confidence Interval|Number
2684096|NCT01370564|Primary|Characterize the Technical Feasibility of the Network Based IPC System|The proportion of study days a PtIS is based on the subjects' daily pressure state|Baseline through Completion/Exit (an average of 3 months)|The analysis population is the total number of study participants. For each study subject, the number of days in which the IPC system delivered a patient instruction set based on the subject's pressure state as measured by the Chronicle ICD/IHM pressure sensor.|||percentage of days|Days|95% Confidence Interval|Mean
2684097|NCT01370538|Primary|Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment||From randomisation to day 14|Per-protocol analysis set|||Percentage of heartburn free days||Standard Deviation|Mean
2684098|NCT01370538|Secondary|Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment|There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6). For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period. However, for subjects reporting anything less than 14 days the two will not be identical. For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn.|From randomisation to day 14|Full Analysis Set|||Participants|||Number
2684099|NCT01370538|Secondary|Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo|The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.|From randomisation to day 14|Full Analysis Set|||Participants|||Number
2684100|NCT01370538|Secondary|Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period|Treatment period is considered to be both weeks 1 and 2 between V3 and V4.|From randomisation to the day 14|Full Analysis Set|||Participants|||Number
2684101|NCT01370538|Primary|Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment||From randomisation to day 14|Full analysis set|||Percentage of heartburn free days||Standard Deviation|Mean
2684102|NCT01370525|Primary|Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment||From randomization to day 14|Per-protocol analysis set|||Percentage||Standard Deviation|Mean
2684103|NCT01370525|Secondary|Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment|There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6). For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period. However, for subjects reporting anything less than 14 days the two will not be identical. For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn.|From randomisation to day 14||||Participants|||Number
2684104|NCT01370525|Secondary|Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo|The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.|From randomisation to the day 14|Full Analysis Set|||Participants|||Number
2684105|NCT01370525|Secondary|Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period|Randomized treatment period is considered as both weeks 1 and 2 between V3 and V4.|From randomisation to day 14|Full Analysis Set|||Participants|||Number
2684106|NCT01370525|Primary|Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment||From randomisation to day 14|Full analysis set|||Percentage||Standard Deviation|Mean
2684107|NCT01370499|Secondary|Change From Baseline to 52 Week Endpoint in Pulse Rate|Pulse measurements were collected when the participant was in a sitting position. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.|Baseline, 52 weeks|All participants who took at least one dose of study medication and had a baseline and at least one post-baseline value.|||beats per minute (bpm)||Standard Error|Least Squares Mean
2684108|NCT01370499|Secondary|Change From Baseline to 52 Week Endpoint in Blood Pressure|Blood pressure measurements were collected when the participant was in a sitting position. Three measurements of sitting blood pressure collected at approximately 1-minute intervals at every visit were averaged and used as the value for the visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.|Baseline, 52 weeks|All participants who took at least one dose of study medication and had a baseline and at least one post-baseline value.|||millimeters of mercury (mmHg)||Standard Error|Least Squares Mean
2684109|NCT01370499|Secondary|Change From Baseline to 52 Week Endpoint in Arizona Sexual Experiences (ASEX) Scale|The Arizona Sexual Experiences (ASEX) scale is used to assess sexual functioning in both males and females. The ASEX total score for the male and female version is calculated as the sum of the responses (rated from 1 [extremely] to 6 [no/never]) to the 5 items of the ASEX scale. Total scores ranged from 5 to 30, with higher scores indicating greater sexual dysfunction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.|Baseline, 52 weeks|All participants who took at least one dose of study medication and had a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2684110|NCT01370499|Secondary|Change From Baseline to 52 Week Endpoint in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)|The CPFQ is a 7-item participant-rated questionnaire pertaining to a participant's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item is scored on a 6-point scale ranging from 1 (greater than normal) to 6 (totally absent). Total scores ranged from 7 to 42. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.|Baseline, 52 weeks|All participants who took at least one dose of study medication and had a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2684111|NCT01370499|Secondary|Change From Baseline to 52 Week Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)|The Q-LES-Q-SF is a self-administered 16-item questionnaire measuring degree of enjoyment and satisfaction experienced in various areas of daily life during the past week on a 5-point Likert scale (1=very poor and 5=very good). The total possible scores range from 16 to 80. Higher scores indicate higher levels of enjoyment/satisfaction. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.|Baseline, 52 weeks|All enrolled participants with a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2684112|NCT01370499|Secondary|Change From Baseline to 52 Week Endpoint in EuroQol Questionnaire - 5 Dimension (EQ-5D)|The 5Q-5D Visual Analog Scale is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score is self-reported using a visual analogue scale, marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.|Baseline, 52 weeks|All enrolled participants with a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2684113|NCT01370499|Secondary|Change From Baseline to 52 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores|The SDS Global Functional Impairment Score (total score) and subscores were completed by the participant and were used to assess the effect of the participant's symptoms on his or her work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. The Global Functional Impairment Score is the sum of the 3 items, and scores ranged from 0 to 30 with high values indicating greater disruption in the participant's work life (work/school impairment score), social life (social life/leisure activities impairment score), and family life (family life/home responsibilities impairment score). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.|Baseline, 52 weeks|All enrolled participants with a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2684114|NCT01370499|Secondary|Change From Baseline to 52 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) Depression and Anxiety Subscale Scores|The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire with 2 subscales: anxiety and depression. The anxiety subscale score is the sum of the 7 odd-numbered items and depression subscale score is the sum of the 7 even-numbered items, giving maximum scores of 21 for each subscale. Scores of 11 or more on either subscale were considered to be a 'significant' case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal'. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.|Baseline, 52 weeks|All enrolled participants with a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2684115|NCT01370499|Secondary|Change From Baseline to 52 Week Endpoint in Fatigue Associated With Depression (FAsD) Average Score and Subscale Scores|"The FAsD is a participant-rated scale with a total of 13 items. Six of the 13 items ask how often participants experience different aspects of fatigue with responses from 1 (never) to 5 (always). Seven of the 13 items ask how often fatigue impacts various aspects of the participant's lives with responses from 1 (not at all) to 5 (very much). The Experience Score was derived by taking the mean of Items 1 through 6, the Impact Score was derived by taking the mean of Items 7 through 13 (applicable items only), and the Average Score was the mean of Items 1 through 13 (derived by taking the mean of all applicable items for each participant). Item 12 applied only to participants with a spouse or significant other and Item 13 applied to participants who had a job or who went to school. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for pooled investigative site and visit, baseline score, and baseline score-by-visit interaction."|Baseline, 52 weeks|All enrolled participants with a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2684116|NCT01370499|Secondary|Change From Baseline to 52 Week Endpoint in Clinical Global Impression - Severity (CGI-S)|Clinical Global Impression - Severity (CGI-S) measures severity of depression at the time of assessment compared with the start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.|Baseline, 52 weeks|All enrolled participants with a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2685199|NCT01361633|Secondary|Continuous Performance Test|Assesses Sustained Attention|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without further patient follow-up|||||||
2684117|NCT01370499|Secondary|Change From Baseline to 52 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Items|The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist (sadness [apparent], sadness [reported], inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items are rated on a scale of 0 to 6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for pooled investigative site and visit, baseline score, and baseline score-by-visit interaction.|Baseline, 52 weeks|All enrolled participants with a baseline and at least one post-baseline value.|||units on a scale||Standard Error|Least Squares Mean
2684118|NCT01370499|Secondary|Percentage of Participants With Suicidal Behaviors and Ideations Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)|"The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation was defined as a yes answer to any 1 of 5 suicidal ideation questions, which included a wish to be dead and 4 different categories of active suicidal ideation. Suicidal behavior was defined as a yes answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as treatment-emergent (TE) if not present at baseline. Percentage of participants was calculated by dividing the number of participants with suicide-related events by the total number of participants at risk, multiplied by 100%. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module."|Baseline through 52 weeks|All participants who took at least one dose of study medication and had a baseline and at least one post-baseline value.|||percentage of participants|||Number
2684119|NCT01370499|Primary|Number of Participants With Clinically Significant Events|Clinically significant events were defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.|Baseline through 52 weeks|All participants who took at least one dose of study medication and did not discontinue from the study for the reason 'Lost to follow-up' at the first post-baseline visit.|||Participants|||Count of Participants
2684120|NCT01370460|Secondary|Postoperative Transfusion Rate|Number of patients with symptomatic (tachycardia, hypotension, presyncope) anemia of < 8.0g/dL hemoglobin, or any hemoglobin <7.0 g/dL, precipitated transfusion.|participants will be followed for the duration of hospital stay, an expected average of 3 days||||participants|||Number
2684121|NCT01370460|Primary|Blood Loss|Preoperative and lowest postoperative hemoglobin|participants will be followed for the duration of hospital stay, an expected average of 3 days||||mL||Standard Deviation|Mean
2684122|NCT01370408|Secondary|Number of Patients That Experience Treatment Failure Within the First 24 Hours|Number of patients with first emetic episode or time to administration of rescue therapy, whichever occurred first, within the first 24 hours|24 hours||||participants|||Number
2684123|NCT01370408|Secondary|Number of Patients That Required First Administration of Rescue Medication Within 24 Hours|Number of patients who required the use of rescue medication (lorazepam, prochlorperazine, promethazine, metoclopramide, scopolamine, or dronabinol) within the first 24 hours|24 hours||||participants|||Number
2684124|NCT01370408|Secondary|Patients Who Experience First Emetic Episode Within 24 Hours|Number of patients with first emetic episode experienced within 24 hours|24 hours||||participants|||Number
2684125|NCT01370408|Secondary|Emetic Episodes|Number of emetic episodes|120 Hours||||episodes||Full Range|Mean
2684126|NCT01370408|Secondary|Complete Control Rate for Nausea & Vomiting|Complete control rate (CC; defined as no emetic episodes, no rescue medication use, and no more than mild nausea)|120 hours||||participants|||Number
2684127|NCT01370408|Secondary|Complete Remission During Overall Chemotherapy Time Period|Proportion of patients achieving a CR during the cumulative overall 0-120 hour time period|120 hours||||participants|||Number
2684128|NCT01370408|Secondary|Complete Remission During Acute Phase Post-chemotherapy|Proportion of patients achieving an acute CINV CR during the acute phase post -chemotherapy (0-24 hours)|24 hours||||participants|||Number
2684129|NCT01370408|Primary|Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting|Proportion of patients achieving a delayed CINV complete response (CR) defined as no emetic episode and no use of rescue medications during the 24-120 hour period post chemotherapy.|120 hours||||participants|||Number
2684130|NCT01370369|Secondary|Frequency of Adverse Events (AEs)|The data were presented using descriptive statistics for this outcome.|From Baseline to Day 43|Safety Analysis Set population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||number of event|||Number
2684131|NCT01370369|Secondary|Pharmacokinetic Parameter : AUC0-24 Observed for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 and/or 24 hr.|||ng*hour/dL||Standard Deviation|Mean
2684132|NCT01370369|Secondary|Pharmacokinetic Parameter - Tmax for DHT With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||hour||Full Range|Median
2684133|NCT01370369|Secondary|Pharmacokinetic Parameter - Cmax for Dihydrotestosterone (DHT) With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||ng/dL||Standard Deviation|Mean
2685565|NCT01358734|Primary|Kaplan Meier Estimates for One Year Survival|One-year survival rate was defined as all deaths within one year from the date of randomization. All others censored at the at year 1 or date of discontinuation|Up to 24 months|ITT included all randomized participants|||months||95% Confidence Interval|Median
2684134|NCT01370369|Secondary|Pharmacokinetic Parameter : AUC0-24 Observed for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 and/or 24 hr.|||pg*hour/mL||Standard Deviation|Mean
2684135|NCT01370369|Secondary|Pharmacokinetic Parameter - Tmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||hour||Full Range|Median
2684136|NCT01370369|Secondary|Pharmacokinetic Parameter - Cmax for Free Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||pg/mL||Standard Deviation|Mean
2684137|NCT01370369|Secondary|Pharmacokinetic Parameter : AUC0-24 Observed for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 and/or 24 hr.|||ng*hour/dL||Standard Deviation|Mean
2684138|NCT01370369|Secondary|Pharmacokinetic Parameter - Tmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||hour||Full Range|Median
2684139|NCT01370369|Secondary|Pharmacokinetic Parameter - Cmax for Total Testosterone With Multiple-dose Profile of IMP After 10 Days of Treatment to Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 23, 33, and 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||ng/dL||Standard Deviation|Mean
2684140|NCT01370369|Secondary|Pharmacokinetic Parameter : Area Under the Plasma Concentration Time Curve From 0 to 24 hr (AUC0-24) Observed for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP. Number of subjects was less than 20 in some group(s) for AUC0-24 as parameter could not be calculated due to missing concentration for 0 hr.|||ng*hour/dL||Standard Deviation|Mean
2684141|NCT01370369|Secondary|Pharmacokinetic Parameter : Time of Maximum Observed Concentration (Tmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh, and Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||hour||Full Range|Median
2684142|NCT01370369|Secondary|Pharmacokinetic Parameter : Maximum Concentration Observed (Cmax) for Total Testosterone, After an Initial Single Treatment (Testosterone) on the Abdomen, Inner Thigh and Shoulder/Upper Arm.|The data were presented using descriptive statistics for this outcome.|Samples were collected at pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 1, 7 and 13|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||ng/dL||Standard Deviation|Mean
2684143|NCT01370369|Primary|Responder Rate - the Percentage of Subjects Whose Minimum Concentration Observed (Cmin) and Average Steady State Concentration (Cave) of Serum Testosterone Levels Were Between 298 and 1043 ng/dL.|Responder rate was calculated for the subjects who received 10 days of treatment with three doses of testosterone gel; 1.25 mL, 2.50 mL, and 3.75 mL, respectively. The data were presented using descriptive statistics for this outcome.|From Baseline to Day 43|ITT population was used for this analysis, which comprised of all subjects who received at least one dose of the IMP.|||percentage of subjects|||Number
2684144|NCT01370356|Secondary|Percentage of Participants With 4-Week Point Prevalence of Smoking Cessation|"The 4-week point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 4 weeks of the study. The participant`s smoking status and other nicotine use was evaluated based on the last 4 weeks questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered no to both questions (Has the subject smoked any cigarettes (even a puff) in the last 4 weeks?; and Has the subject used any nicotine products and/or other tobacco.... in the last 4 weeks?) and whose expired CO < 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm)."|Week 52|The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.|||percentage of participants|||Number
2684157|NCT01370265|Secondary|Hyperemic Segmental MBF|"Regional MBFs were calculated using commercial software (PMOD Technologies, version 2.4). After the apical and basal slices of the left ventricular myocardium were chosen, the software automatically defined 4 myocardial regions of interest (segments) in the apical planes.~The hyperemic MBF was measured approximately 4 hours after arrival in the PET unit, depending on the randomization."|Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit|Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.|||mL/min/gm||Standard Deviation|Mean
2684145|NCT01370356|Secondary|Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation|"The 7-day point prevalence of abstinence was defined as being abstinent from smoking and using tobacco products during the last 7 days at Week 12, 24, and 52. The participant`s smoking status and other nicotine use was evaluated based on the last 7 days questions on the NUI and confirmed by CO expiration. Responders were defined as those, who answered no to both questions (Has the subject smoked any cigarettes (even a puff) in the last 7 days?; and Has the subject used any nicotine products and/or other tobacco.... in the last 7 days?) and whose expired CO < 10 ppm. Missing CO was imputed as negative (CO ≤ 10 ppm)."|Week 12, 24, and 52|The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.|||percentage of participants|||Number
2684146|NCT01370356|Secondary|Percentage of Participants With CO Confirmed Long Term CA From Smoking|Percentage of participants who remained abstinent from Week 21 to Week 52, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 52, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).|Weeks 21 - 52|The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.|||percentage of participants|||Number
2684147|NCT01370356|Secondary|Percentage of Participants With CO Confirmed 4-Week CA From Smoking|Percentage of participants who remained abstinent from Week 21 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the NUI and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 21 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).|Week 21 - 24|The Full Analysis Set was referred to as the ITT population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.|||percentage of participants|||Number
2684148|NCT01370356|Primary|Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking|Percentage of participants who remained abstinent from Week 15 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the Nicotine Use Inventory (NUI) and confirmed by expired CO < 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 15 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).|Week 15 - 24|The Full Analysis Set was referred to as the Intent-to-Treat (ITT) population and was defined as all randomized participants. The ITT population was the primary analysis set for the efficacy analyses in this study.|||percentage of participants|||Number
2684149|NCT01370317|Primary|Number of Participants Who Discontinued Study Treatment Due to An Adverse Event|An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Up to 28 days after initial dose of study treatment|All participants who received at least one dose of study drug|||Participants|||Count of Participants
2684150|NCT01370317|Secondary|Time to Maximum Plasma Concentration (Tmax) of MK-1029|Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Tmax of MK-1026.|Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose|All participants who received study drug and had evaluable concentration values for Tmax on Day 1 and Day 28|||Hours||Full Range|Median
2684151|NCT01370317|Secondary|Maximum Plasma Concentration (Cmax) of MK-1029|Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Cmax of MK-1026.|Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose|All participants who received study drug and had evaluable concentration values for Cmax on Day 1 and Day 28|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2684152|NCT01370317|Secondary|Area Under the Concentration-Time Curve From Time 0 to 6 Hours (AUC0-6hr) of MK-1029|Blood was collected on Day 1 and Day 28 at predose and 1, 2, 3, 4 and 6 hours postdose for determining the Cmax of MK-1026.|Day 1 and Day 28: Predose, 1, 2, 3, 4, and 6 hours postdose|All participants who received study drug and had evaluable concentration values for AUC0-6 hours on Day 1 and Day 28|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2684153|NCT01370317|Primary|Number of Participants Who Experienced One or More Adverse Events|An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.|Up to 42 days after initial dose of study treatment|All participants who received at least one dose of study drug|||Participants|||Count of Participants
2684154|NCT01370265|Secondary|Hyperemic Blood Pressure (mmHg)|Blood pressure was measured approximately 4 hours after arrival in the PET unit, depending on the randomization.|Day 2, approximately 4 hours after arrival in the PET unit|Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.|||mmHg||Standard Deviation|Mean
2684155|NCT01370265|Secondary|Heart Rate (Beats Per Minute (BPM))|The resting heart rate was measured approximately 35 minutes after arrival in the PET unit. The hyperemic heart rate was measured approximately 4 hours after arrival in the PET unit, depending on the randomization.|Day 2, approximately 35 minutes and approximately 4 hours after arrival in the PET unit|Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.|||bpm||Standard Deviation|Mean
2684156|NCT01370265|Secondary|Segmental CFR|CFR was calculated using the equation: hyperemic MBF/resting MBF.|Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit|Analysis per protocol, one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.|||ratio||Standard Deviation|Mean
2684208|NCT01369784|Secondary|Ann Arbor Staging|Ann Arbor=I: Best condition Ann Arbor=IV: Worst condition|At the beginning of the 2nd line of treatment||||percentage of patients|||Number
2684158|NCT01370265|Secondary|Global Cardiac Flow Rate|Cardiac Flow Rate was calculated using the equation: hyperemic MBF/resting MBF.|Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit|Analysis per protocol, one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.|||ratio||Standard Deviation|Mean
2684159|NCT01370265|Secondary|Resting Global MBF and Resting Segmental MBF|"MBF is the rate of blood supplied to the myocardium, or heart muscle. Global Myocardial blood flow was calculated using commercial software (PMOD Technologies, version 2.4).~Regional MBFs were calculated using commercial software (PMOD Technologies, version 2.4). After the apical and basal slices of the left ventricular myocardium were chosen, the software automatically defined 4 myocardial regions of interest (segments) in the apical planes."|Day 2, approximately 35 minutes after arrival in positron emission tomography (PET) unit|Resting MBF was measured on all subjects prior to the interventions.|||ml/min/gm||Standard Deviation|Mean
2684160|NCT01370265|Primary|Global Hyperemic Myocardial Blood Flow (MBF)|"MBF is the rate of blood supplied to the myocardium, or heart muscle. Hyperemic MBF is the rate of myocardial blood flow in the heart muscle during either regadenoson or adenosine stress. Myocardial blood flow was calculated using commercial software (PMOD Technologies, version 2.4).~The Hyperemic MBF was measured approximately 4 hours after arrival in the PET unit."|Day 2, approximately 4 hours after arrival in positron emission tomography (PET) unit|Analysis per protocol; one participant in each group experienced an ischemic ECG with the first stress drug, and they were withdrawn from the study. This is a per intervention presentation.|||mL/min/gm||Standard Deviation|Mean
2684161|NCT01370213|Secondary|Number of Participants With Early In Vivo Expansion of Natural Killer (NK) Cells|Successful in vivo donor NK cell expansion will be defined by measuring an absolute circulating donor-derived NK cell count of >100 cells/μl in patient's peripheral blood 12 days after infusion.|Day 12|"CD34 Graft - of 7, 1 NA due to missing data/tests not performed, 1 not evaluable.~TCRα/β Schema - of 17 patients, 15 were evaluable for outcome measure criteria, 2 were not evaluable.~TCRα/β Schema + ATG at different time - 1 given ATG at different time, results reported separately."|||Participants|||Count of Participants
2684162|NCT01370213|Secondary|Number of Participants Who Relapse|Cumulative incidence will be used to estimate relapse.|2 Years|"CD34 Graft - of 7, 1 patient not evaluable, 2 patients did not clear disease, 2 died before 2 years.~TCRα/β Schema - of 17, 7 didn't achieve remission, 2 died before 2 years, 2 were not evaluable.~TCRα/β Schema + ATG at different time - 1 patient received ATG at different time, results reported separately."|||Participants|||Count of Participants
2684163|NCT01370213|Secondary|Number of Participants With Treatment Related Mortality (TRM)|Cumulative incidence will be used to estimate TRM.|At 6 Months|"CD34 Schema - of 7 patients, 1 was not evaluable. TCRα/β Schema - of 17 patients, 8 died of disease, 2 did not have TRM at 6 months, 2 were not evaluable.~TCRα/β Schema + ATG at different time - 1 patient given ATG at different time, results reported separately."|||Participants|||Count of Participants
2684164|NCT01370213|Secondary|Number of Participants With Disease Free Survival||At 6 Months|"CD34 Schema - of 7, 1 patient was not evaluable. TCRα/β Schema - of 17, 15 patients evaluable for DFS , 2 patients were not evaluable.~TCRα/β Schema + ATG at different time - 1 patient given ATG at different time so results reported separately"|||Participants|||Count of Participants
2684165|NCT01370213|Primary|Number of Participants With Donor Neutrophil Engraftment|The rate of donor neutrophil engraftment in the absence of leukemia at day +28 will be determined. Successful neutrophil engraftment is defined as an absolute donor-derived neutrophil count of >500 cells/μl. Leukemia free is defined as <5% bone marrow blasts, absence of blasts with Auer rods; absence of extramedullary disease; but cytogenetic or molecular minimal residual disease is allowed.|Day 28|"CD34 Schema - out of 7 patients, 2 patients were NA due to leukemia, 1 died, and 1 was not evaluable so 3 were analyzed (4 were not).~TCRα/β Schema - out of 17 patients, 6 patients were NA due to leukemia, 2 were not evaluable.~TCRα/β Schema + ATG - 1 patient was given ATG at a different time so their results were reported separately"|||Participants|||Count of Participants
2684166|NCT01370083|Secondary|Tongue-palate Pressure Amplitude for Maximum Isometric Pressures|We will measure the amplitude of peak tongue-pressure amplitudes on maximum isometric pressure tasks performed using the Iowa Oral Performance Instrument. The maximum amplitude across a series of 3 maximum isometric pressure tasks performed with the bulb in a posterior position (flat end aligned with the first molar tooth) will be used to document tongue strength.|Post-treatment value|Individuals with complete pre and post-treatment data available|||Kilopascals||Standard Deviation|Mean
2684167|NCT01370083|Secondary|Penetration-Aspiration Scale Score for 5 cc Thin Liquid Swallows|The Penetration-Aspiration Scale is an 8-point ordinal scale that addresses the depth of airway invasion and response to airway invasion during swallowing. We will measure penetration-aspiration for a series of 3 X 5 cc thin liquid swallows in videofluoroscopy. The participant's worst score will be taken to reflect their swallowing safety. This score will be collapsed into a binary score < vs. > 3 on the scale, reflecting material entering and remaining in or below the supraglottic space (versus transient entry or no entry at all).|Post-treatment (12 weeks)|Participants with complete pre and post-treatment videofluoroscopy data available.|||participants|||Number
2684168|NCT01370083|Primary|Change in Swallow Response Time for 5 cc Thin Liquid Swallows|Swallow response time (the time duration between bolus passing the ramus of the shadow of the mandible and onset of hyolaryngeal excursion for airway protection 5cc thin liquid barium boluses in videofluoroscopy. Measures > 350 ms are considered to reflect impairment and a heightened risk of penetration-aspiration. The participant's mean swallow response time will be calculated across a series of 3 X 5 cc swallows and then reduced to a binary score < vs > 350 milliseconds.|Post treatment (12 weeks)||||participants|||Number
2684169|NCT01370005|Other Pre-specified|Confirmed Hypoglycaemic Adverse Events|Number of participants with confirmed hypoglycaemic adverse events|From drug administration until last drug administration plus seven days, up to 171 days|Treated set which included all patients treated with at least one dose of randomised trial medication. Treatment assignment as first medication taken.|||participants|||Number
2684170|NCT01370005|Secondary|Orthostatic Blood Pressure|Orthostatic blood pressure (BP) at baseline and after 12 weeks of treatment.|Baseline and 12 weeks|Treated set for patients with available measurements at baseline and week 12. Treatment assignment as first medication taken.|||participants|||Number
2684171|NCT01370005|Secondary|Composite Endpoint of Change From Baseline of HbA1c, Systolic Blood Pressure and Body Weight|A composite endpoint of the following conditions at week 12 compared to baseline (all 3 fulfilled): reduction of HbA1c from baseline of at least 0.5%, reduction of systolic blood pressure > 3 mmHg from baseline and reduction of weight from baseline > 2%|Baseline and 12 weeks|"Patients in the full analysis set (FAS). Treatment assignment as randomised.~Non-completers (missing data due to early discontinuation, values after start of rescue medication or changes in antihypertensive therapy) considered 'failure' was used as the imputation rule."|||participants|||Number
2684172|NCT01370005|Secondary|Proportion of Patients Reaching Blood Pressure <130/80 mmHg|Proportion of patients reaching blood pressure <130/80 mmHg after 12 weeks of treatment|Baseline and 12 weeks|"Patients in the FAS without blood pressure control at baseline. Blood pressure control is defined as DBP<80 mmHg and SBP <130 mmHg. Treatment assignment as randomised.~Non-completers (missing data due to early disc, values after start of rescue medication or changes in antihyp. therapy) considered 'failure' was used as the imputation rule."|||participants|||Number
2684173|NCT01370005|Secondary|Trough Mean Seated Diastolic Blood Pressure (DBP) Change From Baseline|Change from baseline in trough mean seated DBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."|||mmHg||Standard Deviation|Mean
2684174|NCT01370005|Secondary|Trough Mean Seated Systolic Blood Pressure (SBP) Change From Baseline|Change from baseline in Trough Mean Seated SBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."|||mmHg||Standard Deviation|Mean
2684175|NCT01370005|Secondary|Nighttime Mean Diastolic Blood Pressure (DBP) Change From Baseline|Change from baseline in nighttime mean DBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."|||mmHg||Standard Deviation|Mean
2684176|NCT01370005|Secondary|Nighttime Mean Systolic Blood Pressure (SBP) Change From Baseline|Change from baseline in nighttime mean SBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."|||mmHg||Standard Deviation|Mean
2684177|NCT01370005|Secondary|Daytime Mean Diastolic Blood Pressure (DBP) Change From Baseline|Change from baseline in daytime mean DBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."|||mmHg||Standard Deviation|Mean
2684178|NCT01370005|Secondary|Daytime Mean Systolic Blood Pressure (SBP) Change From Baseline|Change from baseline in daytime mean SBP after 12 weeks of treatment.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."|||mmHg||Standard Deviation|Mean
2684179|NCT01370005|Secondary|Body Weight Change From Baseline|Change from baseline in body weight after 12 weeks of treatment.|Baseline and 12 weeks|"Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy were set to missing and LOCF was used for imputation of missing values."|||kg||Standard Deviation|Mean
2684180|NCT01370005|Secondary|Fasting Plasma Glucose (FPG) Change From Baseline|Change from baseline in FPG after 12 weeks of treatment.|Baseline and 12 weeks|"Full analysis set (FAS) which included all randomised and treated patients who had a baseline HbA1c value and a baseline mean 24-h systolic blood pressure (SBP) value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy were set to missing and LOCF was used for imputation of missing values."|||mg/dL||Standard Deviation|Mean
2684181|NCT01370005|Secondary|Proportion of Patients With HbA1c <7%|Proportion of patients with HbA1c <7% after 12 weeks.|Baseline and 12 weeks|"Patients in the full analysis set (FAS) and with baseline HbA1c >= 7%. Treatment assignment as randomised.~Non-completers (missing data due to early discontinuation or values after start of rescue medication) considered 'failure' was used as the imputation rule."|||participants|||Number
2684182|NCT01370005|Secondary|Mean 24-hour Diastolic Blood Pressure Change From Baseline|Change from baseline in mean 24-hour diastolic blood pressure (DBP) after 12 weeks.|Baseline and 12 weeks|"FAS which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."|||mmHg||Standard Deviation|Mean
2684183|NCT01370005|Primary|Mean 24-hour Systolic Blood Pressure Change From Baseline|Change from baseline of mean 24-hour systolic blood pressure (SBP).|Baseline and 12 weeks|"FAS, which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and LOCF was used for imputation of missing values."|||mmHg||Standard Deviation|Mean
2684209|NCT01369784|Secondary|Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status|ECOG=0: Fully active, able to carry on all pre-disease performance without restriction ECOG=5: Exitus|At the beginning of the 2nd line of treatment||||participants|||Number
2684184|NCT01370005|Primary|HbA1c Change From Baseline|Change from baseline in HbA1c after 12 weeks of treatment.|Baseline and 12 weeks|"Full analysis set (FAS), which included all randomised and treated patients who had a baseline HbA1c and a baseline mean 24-h systolic blood pressure value. Treatment assignment as randomised.~Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values."|||percentage of HbA1c||Standard Deviation|Mean
2684185|NCT01369888|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|8 months, 9 days||||participants|||Number
2684186|NCT01369888|Primary|Phase 1: Maximum Tolerated Dose (MTD) of Intravenous Recombinant IL-15 as a Daily Intravenous Bolus for 10 Consecutive Days in Patients With Metastatic Melanoma Who Have Received a Lymphodepleting Chemotherapy and ACT TIL.|Intravenous recombinant IL-15 as a daily intravenous bolus for 10 consecutive days in patients with metastatic melanoma who have received a lymphodepleting chemotherapy and ACT TIL with dose escalation (i.e., dose level 1: 0.25 mcg, dose level 2: 0.50 mcg, dose level 3: 1 mcg, and dose level 4: 2 mcg) to further characterize the safety of the MTD prior to starting the phase 2 portion.|2 years||||mcg/kg/day|||Number
2684187|NCT01369875|Secondary|Number of Participants With Serious and Non-Serious Adverse Events|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, up to approximately 8 months.||||Participants|||Count of Participants
2684188|NCT01369875|Primary|Number of Participants With Clinical Tumor Regression.|Clinical tumor regression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is a disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD.|up to approximately 8 months||||Participants|||Count of Participants
2684189|NCT01369849|Secondary|Treatment-free Survival|Treatment free survival is defined to be the time from registration to the date of initation of subsequent therapy or death. The distribution of treatment free survival will be estimated using the method of Kaplan-Meier.|Time from registration to the date of initiation of subsequent therapy or death, median follow-up time is 37 months|All patients that were treated and evaluable were included in this endpoint.|||months||95% Confidence Interval|Median
2684190|NCT01369849|Secondary|Overall Response Rate|The Overall response rate is estimated by the total number of complete or partial responses (CR, CRi, CCR, nPR, or PR) divided by the total number of evaluate patients. Complete and partial responses were scored using the NCI Working Group criteria. A Complete Response (CR, CRi, and CCR) is characterized by an absence of lymphadenopathy, heptomegaly and splenomegaly with or without normalized blood counts and bone marrow assessment . A PR is defined as having >50% decrease in lymphocyte count and reduction in sum of the products of measured nodes and an improvement in blood counts. Exact binomial 95% confidence intervals for the true overall response rate will be calculated.|3 months post-treatment|All patients that were treated and evaluable for response were included together in this endpoint.|||proportion of patients||95% Confidence Interval|Number
2684191|NCT01369849|Secondary|Minimal-residual Disease|Minimal residual disease (MRD) will be evaluated after treatment in patients who achieve a complete clinical response. Flow cytometry will be used to detect approximately 1 CLL cell per 10,000 leukocytes following induction. A score of positive means CLL cells were found and a negative score means no CLL cells were found. The number of patients with an MRD negative score are reported here.|Cycle 6 assessment (maximum of 231 days post-registration)|5 patients achieved a complete response and were analyzed for MRD|||Participants|||Count of Participants
2684192|NCT01369849|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved a clinical response as the date at which the patient's objective status is first noted to be a CR, CRi, CCR, nPR, or PR to the earliest date progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.|Median follow-up of 39 months and maximum follow-up of 54 months|12 patients achieved a response and were included in this analysis.|||months||95% Confidence Interval|Median
2684193|NCT01369849|Secondary|Fluorescent in Situ Hybridization (FISH) Biomarker Analysis|Fluorescent in situ hybridization (FISH) is a molecular cytogenetic technique that uses fluorescent probes that bind to only those parts of the chromosome with a high degree of sequence complementarity. It was developed by biomedical researchers in the early 1980s and is used to detect and localize the presence or absence of specific DNA sequences on chromosomes. In this disease group, there are recognized patterns of DNA sequences that play a role in prognostic outcomes. Patterns named 11q-, 13q-, Trisomy 12 may lead to different responses to treatments. Here we report the number of patients with each FISH prognosis evaluated pre-treatment. These factors will be summarized and used to help characterize the types of patients accrued to this trial.|Baseline|All patients that started treatment and had baseline biomarkers completed were included in this analysis. One of the 4 patients accrued to dose level 2 was not eligible for this endpoint. Therefore, 6 patients at Dose Level 1 and 3 patients at Dose Level 2 and 4 patients accrued to the Phase II portion of the study are included in this endpoint.|||Participants|||Count of Participants
2684194|NCT01369849|Secondary|Biomarker Analysis (CD38, CD49d, and ZAP-70)|CD38, CD49d, and ZAP-70 status will be evaluated pre-treatment. These factors will be summarized and used to help characterize the types of patients accrued to this trial.|Baseline|All patients that started treatment and had baseline biomarkers completed were included in this analysis. One of the 4 patients accrued to dose level 2 was not eligible for this endpoint. Therefore, 6 patients at Dose Level 1 and 3 patients at Dose Level 2 and 4 patients accrued to the Phase II portion of the study are included in this endpoint.|||Participants|||Count of Participants
2684195|NCT01369849|Secondary|Biomarker Analysis (IgVH Gene Mutation)|IgVH gene mutationwill be evaluated pre-treatment. This factors will be summarized and used to help characterize the types of patients accrued to this trial.|Baseline|All patients that started treatment and had baseline biomarkers completed were included in this analysis. One of the 4 patients accrued to dose level 2 was not eligible for this endpoint. Therefore, 6 patients at Dose Level 1 and 3 patients at Dose Level 2 and 4 patients accrued to the Phase II portion of the study are included in this endpoint.|||Participants|||Count of Participants
2684196|NCT01369849|Primary|Proportion of Complete Response Defined to be a CR or CRi Noted as the Objective Status (Phase II)|"A Complete Response (CR) is defined by the NCI Working Group criteria and requires all of the following for a period of at least 2 months:~Absence of lymphadenopathy (e.g. lymph nodes >1.5 cm) by physical examination.~No hepatomegaly or splenomegaly by physical examination.~Absence of constitutional symptoms.~Neutrophils ≥1500/ul.~Platelets >100,000/ul (untransfused).~Hemoglobin >11.0 gm/dl (untransfused)~Peripheral blood lymphocytes <4000/uL~Patients who fulfill all criteria for a CR but who have a persistent anemia, thrombocytopenia, or neutropenia related to drug toxicity rather than residual CLL will be classified as CR with incomplete marrow recovery (CRi).~The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner."|From registration to response, up to 84 days|All eligible patients treated at Dose Level 1 were included in the Phase II primary endpoint. All 6 patients from Phase I, Dose level 1 and 4 of the 5 patients registered to the Phase II portion of the study were eligible for this endpoint.|||percentage of participants||95% Confidence Interval|Number
2684197|NCT01369849|Primary|Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)|The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD.The number of patients reporting a dose-limiting event are reported.|Up to 35 days|Only the patients registered to the Phase I portion of this study were analyzed for this endpoint. One of the 4 patients accrued to dose level 2 was not eligible for this endpoint. Therefore, 6 patients at Dose Level 1 and 3 patients at Dose Level 2 are included in this endpoint.|||Patients reporting Dose-Limiting Events|||Number
2684198|NCT01369784|Post-Hoc|Relationship Between Global Response Rate to 2nd Line of Treatment and Beta-2 Microglobulin at Relapse|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At relapse||||mg/100ml||Standard Deviation|Mean
2684199|NCT01369784|Post-Hoc|Relationship Between Global Response Rate to 2nd Line of Treatment and Lymphocyte/Monocyte Rate on Relapse|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At relapse||||participants|||Number
2684200|NCT01369784|Post-Hoc|Relationship Between Global Response Rate to 2nd Line of Treatment and Absolute Lymphocyte Count on Relapse|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At relapse||||participants|||Number
2684201|NCT01369784|Secondary|Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At diagnosis||||participants|||Number
2684202|NCT01369784|Secondary|Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At diagnosis||||participants|||Number
2684203|NCT01369784|Secondary|Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At diagnosis||||participants|||Number
2684204|NCT01369784|Secondary|Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis|Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse|At diagnosis||||participants|||Number
2684205|NCT01369784|Primary|Predictive Value of R-IPI at Diagnosis||At diagnosis||||participants|||Number
2684206|NCT01369784|Secondary|Response to Second Line of Treatment|"Complete Response (CR), Disappearance of all target lesions for at least 8 weeks.~Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment."|After second line of treatment||||participants|||Number
2684207|NCT01369784|Secondary|Response to First Line of Treatment|"Complete Response (CR), Disappearance of all target lesions for at least 8 weeks.~Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment."|After first line treatment||||participants|||Number
2684214|NCT01369784|Primary|R-IPI Index (Revised International Prognostic Index)|The IPI is based on the evaluation of 5 clinical factors: age > 60 years Ann Arbor stage III or IV disease > 1 extra nodal site European Cooperative Oncology Group performance status (ECOG PS) _ 2, increased serum LDH (lactate dehydrogenase) levels Revised IPI (R-IPI) evaluates the same parameters, but groups them differently to form 3 prognostic groups of patients with significantly different progression-free survival and overall survival outcomes.|At the beginning of the 2nd line of treatment, an average of 2 years||||percentage of patients|||Number
2684215|NCT01369784|Secondary|Bcl-6 Expression|immunohistochemical reaction of cells with Bcl-6 antibody|At the beginning of the second line of treatment||||percentage of participants|||Number
2684216|NCT01369784|Secondary|Bcl-6 Expression|immunohistochemical reaction of cells with Bcl-6 antibody|At diagnosis||||participants|||Number
2684217|NCT01369784|Secondary|Bcl-2 Expression|immunohistochemical reaction of cells with Bcl-2 antibody|At the beginning of the 2nd line of treatment||||participants|||Number
2684218|NCT01369784|Secondary|Bcl-2 Expression|immunohistochemical reaction of cells with Bcl-2 antibody|At diagnosis||||percentage of participants|||Number
2684219|NCT01369784|Primary|R-IPI Index (Revised International Prognostic Index)|Data will be recorded from diagnosis to second line response, an expected average of 7 months|At diagnoses||||percentage of participants|||Number
2684220|NCT01369758|Secondary|Percentage of Subjects That Achieve 100% Removal of Target Pathology|Percentage of subjects that achieve 100% removal of target pathology, as determined by hysteroscopic exam following the treatment procedures.|1 hour post treatment||||percentage of participants||95% Confidence Interval|Number
2684221|NCT01369758|Primary|Procedure Efficacy|Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatment procedure|1 hour post treatment|559 pathologies, 187 Fibroids and 372 polyps, were removed from 278 patients.|||percent of pathology||95% Confidence Interval|Mean
2684222|NCT01369745|Secondary|Time to Failure (Days)|Patients will be monitored for addition of any DMARD or withdrawal due to flare. The time to failure is defined as the duration of study participation (in days) until a qualifying event or completion of study treatment, whichever comes first.|Baseline to 12 weeks|Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.||||||
2684223|NCT01369745|Secondary|Multidimensional Assessment of Fatigue (MAF) at Week 12|"The Multidimensional Assessment of Fatigue (MAF) scale contains 16 items and measures four dimensions of fatigue: severity (#1-2), distress (#3), degree of interference in activities of daily living (#4-14), and timing (#15-16). Fourteen items contain numerical rating scales (#1-14) and two items have multiple-choice responses (#15-16). Respondents are asked to reflect on fatigue patterns for the past week.~To calculate the Global Fatigue Index (GFI): Convert item #15 to a 0-10 scale by multiplying each score by 2.5 and then sum items #1, 2, 3, average #4-14, and newly scored item #15.~Scores range from 1 (no fatigue) to 50 (severe fatigue). Do not assign a score to items #4-14 if respondent indicated they do not do any activity for reasons other than fatigue. If respondents select no fatigue on item #1, assign a zero to items #2-16. Item #16 is not included in the Global Fatigue Index."|week 12|Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.||||||
2684224|NCT01369745|Secondary|Percentage of Subjects Achieving ACR20, ACR50 and ACR70 at 12 Weeks|The American College of Rheumatology (ACR) 20 is a widely accepted composite index of improvement in RA proposed by the ACR (Fransen and van Riel 2009). ACR20 refers to a composite improvement of 20% in swollen joint count, tender joint count, and 3 or more of the following 5 measures:Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient Pain VAS, Patient's self-addressed disability (HAQ) (Arnet 1988 and Felson 1995), Acute-phase reactant (ESR or CRP) The ACR 50 and ACR 70 are similar tools, used to indicate 50% and 70% improvement, respectively.|Week 12|Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.||||||
2684225|NCT01369745|Secondary|Change From Baseline in DAS28-CRP Individual Components at 12 Weeks|"The mean change in the individual components of the Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12 which included individual assessment of Tender Joint Count (28-joint assessment), Swollen Joint Count (28-joint assessment), Patient Global Assessment of Disease Activity and absolute CRP level. In each case, higher scores indicate more disease activity.~The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity."|Baseline to week 12|Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.||||||
2684226|NCT01369745|Primary|Change From Baseline in DAS28-CRP at 12 Weeks|"The primary efficacy endpoint was the mean change in Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12.~The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of <3.2 suggests a low level of disease activity, while a score of >5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤3.2 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores."|baseline to week 12|The efficacy analysis population includes all 252 subjects who received at least one dose of study drug after randomization and who provided at least one post-baseline measurement of the primary endpoint|||units on a scale||Standard Deviation|Mean
2684234|NCT01369680|Secondary|Pain Control|"Subjects will be assessed for clinically significant change in pain scores during and after study drug administration. Significant change in pain scores were determined at week 2, though week 14 scores were collected as well.~Participants with a 2 point (or greater) decrease in pain scores compared to baseline were considered to have responded. The NRS scale was used, the scale ranges from 0-10, with 10 being the most pain."|Week 2|Number of participants for analysis was determined in negotiation with the FDA for safety of all participants.|||participants|||Number
2684235|NCT01369680|Secondary|Norketamine Cmax (Measured in ng/mL).|Pharmacokinetic testing will be done during chronic ketamine administration on subjects consenting to additional testing one week into study drug administration. This is to further describe the activity of ketamine in the blood of children when administered chronically and to enable comparison of any clinical effect or toxicity with steady state levels of ketamine in children.|At week 1|All participants consenting for pharmacokinetics were analyzed. No participants in ketamine 1.5 mg/kg/dose group consented for pharmacokinetics.|||ng/mL||Full Range|Mean
2684236|NCT01369680|Secondary|Neurocognitive Effect|"Baseline neurocognitive testing will be done before study drug is given. Subjects will be reassessed for any changes in neurocognitive scores at end of dosing (week 2) and at three weeks off study drug (week 14). Significant changes were measured at week 14 compared to baseline. Week 2 was measured to inform future studies.~The neurocognitive scores are standardized scores with a mean of 100; low scores correlate with low neurocognitive function, while high scores correlate with high function. A significant change is defined as greater than or equal to 10% decrease in scores."|At 14 weeks|All participants not lost to follow-up were analyzed|||participants|||Number
2684237|NCT01369680|Primary|Number of Participants Tolerating Dose|According to CTCae any dose causing grade 2 or worse toxicity will be an untolerated dose. Tolerability is defined as ability to take the medication for 2 weeks without having a grade 2 or worse toxicity.|Up to 2 weeks|Number of participants was determined through negotiation with the FDA for safety of all participants.|||participants|||Number
2684238|NCT01369641|Primary|Efficacy of Intratympanic Sodium Thiosulfate (STS)|"To assess the efficacy of intratympanic sodium thiosulfate (STS) on reducing the degree or incidence of hearing loss in patients receiving systemic cisplatin therapy using puretone and speech audiometry, and distortion product otoacoustic emissions (DPOAE).~Pure tone and speech audiometry: hearing will be assessed prior to any initiation of cisplatin therapy, again at three weeks, 6 weeks, 12 weeks, and every 6 months thereafter for up to one year."|Through 1 year post-treatment|||||||
2684239|NCT01369615|Primary|The Number of Participants With Adverse Events as a Measure of Safety.|Safety assessments included adverse events (AEs), vital sign measurements, clinical laboratory test results, and somnolence (University of Michigan Sedation Scale [UMSS]). Safety variables were summarized descriptively within age group for the extension safety population.|Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment).|The extension safety population was the group of patients who received at least 1 dose of study drug during the Extension Study.|||participants|||Number
2684240|NCT01369511|Secondary|Change From Baseline in Appendicular Lean Body Mass (aLBM) at Weeks 4, 8, and 16|The percentage change in aLBM of 3 limbs (excluding the operated limb) was measured by DEXA. LS means of the aLBM change from baseline to the 12 week endpoint was adjusted by baseline aLBM values as a covariate and treatment, visit, and the treatment-by-visit interaction were included as fixed effect via an MMRM analysis.|Baseline, 4 Weeks, 8 Weeks, and 16 Weeks|Randomized participants with non-missing baseline and at least 1 post-baseline aLBM measure.|||percentage change in aLBM (3 limbs)||Standard Error|Least Squares Mean
2684241|NCT01369511|Primary|Change From Baseline in Appendicular Lean Body Mass (aLBM) at Week 12|The percentage change in aLBM of 3 limbs (excluding the operated limb) was measured by dual energy x-ray absorptiometry (DEXA). Least squares (LS) means of the aLBM change from baseline to the 12 week endpoint was adjusted by baseline aLBM values as a covariate and treatment, visit, and the treatment-by-visit interaction were included as fixed effect via a mixed-effects model for repeated measured (MMRM) analysis.|Baseline, 12 Weeks|Randomized participants with non-missing baseline and at least 1 post-baseline aLBM measure.|||percentage change in aLBM (3 limbs)||Standard Error|Least Squares Mean
2684242|NCT01369485|Primary|Evaluate the Median Change From Baseline in Mean Urgency (Urinary) Incontinence Episodes (Leaks) Between the Active and Sham Treatment Groups|"The primary objective of the randomized phase of the study is to evaluate the 12 week and 12 month median change from baseline in mean urgency (urinary) incontinence episodes (leaks) between treatment groups. The mean of the number of urinary incontinence episodes over 24 hours is defined as the mean of the number of UIEs recorded per 24 hour period for three consecutive days (via a 3-day diary).~Mean urinary frequency episodes calculated for each patient during time period. The median change in frequency was then calculated for each treatment group. Distribution of changes from baseline were then assessed prospectively for normality using the Kolmogorov - Smirnoff test. Since departure from normality was actually observed in the distribution, the Wilcoxon Rank-Sum test was performed to compare the median change between treatment groups and the p-values for the test of equality of medians were reported along with the medians."|12 weeks (Randomized Phase) and 12 Months (Open Label)||||Episodes/day||Inter-Quartile Range|Median
2684243|NCT01369485|Secondary|Change Clinical Global Impressions at 12 Weeks|"CGI is an Investigator assessment, which rates the severity of illness at baseline on a scale of 1 (normal, not ill at all) to 7 (Amongst the most extremely ill patients), and then rates improvement at 12 weeks on a scale of 1 (very much improved) to 10 (very much worse). The analysis was based upon the number of patients that much and very much improved."|12 weeks (Randomized Phase) and 12 Months (Open Label Phase)|Intent to treat|||% patients much or very much improved|||Number
2684244|NCT01369485|Secondary|Assessment of Improvement as Measure by Overactive Bladder Satisfaction With Treatment Questionnaire (OAB-SAT)|Overall satisfaction with treatment was assessed (OAB-SAT-q) an 11 question list with multiple scaled checkboxes to allow the subject to rate the treatment with regard to satisfaction, bother from side effects, treatment endorsement, and convenience.|12 weeks|Intent to treat population for those who had prior treatment for OAB.|||percentage of patient prefer treatment|||Number
2684425|NCT01368081|Primary|Number of Patients With Drug Related Adverse Events|Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days|After the first drug intake until 7 days after the last treatment administration, up to 383 days|Treated patients|||participants|||Number
2684245|NCT01369485|Secondary|Assessment of Treatment Benefit Scale (TBS)|TBS is a patient-reported outcome comprised of a 4-point scale of checkboxes to describe the change in condition during treatment (greatly improved to worsened). Improvement was defined as a change in the patient's assessment of overall condition to improved or greatly improved over the course of treatment. Analysis was based upon the number of patients who reported an improvement in condition.|12 Weeks|Intent to Treat|||percentage patients improved (responded)|||Number
2684246|NCT01369485|Secondary|Change in Patient Perception of Bladder Condition (PPBC) From Baseline (Screening Period) to Week 12 as Defined as an Improvement in Severity.|PPBC is a 6-point scale (from 'no problems at all' to 'many severe problems') describing the problem level of the bladder condition at that moment. Improvement is defined as a reduction in the number and/or severity of observed problems.|12 Weeks (Randomized Phase) and 12 Months (Open Label Phase)|Intent to Treat|||percentage of patients that improved|||Number
2684247|NCT01369485|Secondary|Change in Median Total Health Related Quality of Life (HRQL) of OAB-q From Baseline (Screening) to Week 12|The OAB-q is validated to measure symptom bother and life impact due to OAB. It consists of an 8-item Bother Scale to assess individual symptoms and a 25-item HRQL scale that in turn consists of 4 subscales (coping-8 items, concern-7 items, sleep-5 items and social-5 items) to assess impact on life. Responses for each item in the Bother Scale range from 1 (bothered not at all by the symptom) to 6 (Bothered A Very Great Deal). Scores are then added generating an overall Bother Score (severity) ranging from 8 to 48. For HRQL, individual responses range between 1-None of the Time to a 6-All of the Time. Subscale scores range from 8-48 (coping) 7-42 (concern), 5-30 (sleep) and 5-30 (social). Subscale scores are then added to generate the HRQL ranging between 25-150. Raw HRQL scores are transformed for standardization purposes as follows: ((Highest Possible Score-Actual Raw Score)/Range of Scores)*1 00 so that scores could range from 0 (All of the Time) to 100 (None of the Time).|12 Weeks (Randomized Phase) and 12 Months (Open Label).|Intent to Treat|||units on a scale||Inter-Quartile Range|Median
2684248|NCT01369485|Secondary|Measure Improvement in the Median of the Mean OAB-Symptom Composite Score|"OAB Symptom Composite Score (OAB-SCS) is a composite symptom score of toilet voids, urgency severity and urge urinary incontinence combining the Indevus Urgency Severity Scale (IUSS) for capture of urgency severity per toilet void with 24-hour frequency and UUI episodes.~IUSS Score/void and/or UUI is assigned an OAB-SCS Point/Void: 0(none)=1, 1(mild/easily tolerated)=2, 2(moderate discomfort interfering with activities)=3, 3(severe/extreme urgency discomfort that abruptly stopped all activity or tasks)=4, UUI without void=5.~Overall OAB-SCS Score is calculated for each day by multiplying the OAB-SCS Points/Void and/or UUIs by the number of events meeting criteria and adding the individual scores together. The minimum overall OAB-SCS score in a 24 hour period would be a 1 (representing a single mild void with a OAB -SCS Point/Void score of 0). The score would increase based upon the number voids/events and overall severity each event. Medians calculated for each treatment group."|12 weeks||||units on a scale||Inter-Quartile Range|Median
2684249|NCT01369485|Secondary|Measure Decrease in the Median Change From Baseline in Mean Urgency Episodes|"Evaluate the 12 week change from baseline in median for mean number of urgency episodes between the active and sham treatment groups.~Patients were required to complete seven 3-day voiding diaries throughout the course of the study. The voiding diary collected the following information: amount voided (in ml); urgency associated with each toileted void , approximate time of leak, and presence of urge preceding leak.The mean number of urgency episodes over 24 hours was then calculated for each patient during the observation period. The change in median for the mean of the number of urgency episodes over 24 hours) for each treatment group was then calculated.~Distribution of changes from baseline were assessed prospectively using the Kolmogorov - Smirnoff test. The Wilcoxon Rank-Sum test was performed to compare the median change between treatment groups and the p-values for the test of equality of medians were reported along with the medians."|12 weeks||||Difference in episodes/24 Hours||Inter-Quartile Range|Median
2684250|NCT01369485|Secondary|Measure Median Change in Mean Volume Per Void|Evaluate the 12 week median change from baseline in mean volume (ml) per void between the active and sham treatment groups|12 weeks||||ml||Inter-Quartile Range|Median
2684251|NCT01369485|Secondary|Measure Change in the Median of the Mean Urinary Frequency|"Evaluate the 12 week change from baseline in median urinary frequency between the active and sham treatment groups.~Mean urinary frequency episodes calculated for each patient during time period. The median change in frequency was then calculated for each treatment group. Distribution of changes from baseline were then assessed prospectively for normality using the Kolmogorov - Smirnoff test. Since departure from normality was actually observed in the distribution, the Wilcoxon Rank-Sum test was performed to compare the median change between treatment groups and the p-values for the test of equality of medians were reported along with the medians."|12 weeks and 12 Months||||Episodes/24 hours||Inter-Quartile Range|Median
2684252|NCT01369485|Primary|Evaluate Proportion of Responders Based on the Change From Baseline in Mean Urgency (Urinary) Incontinence Episodes (Leaks) Between the Active and Sham Treatment Groups|"The primary objective of the randomized phase of the study is to evaluate the 12 week change from baseline in mean urgency (urinary) incontinence episodes (leaks) between the active and sham treatment groups. The mean of the number of urinary incontinence episodes over 24 hours is defined as the mean of the number of UIEs recorded per 24 hour period for three consecutive days (via a 3-day diary).~The primary objective of the open label phase of the study is to evaluate and confirm the continued efficacy of the VERV™ System for long-term use. The primary objective was assessed with rate of responders, where responder was defined as a subject who achieved a decrease of ≥50% in mean urgency urinary incontinence episodes at 12 weeks compared to baseline."|12 weeks (Randomized Phase) and 12 Months (Open Label)|Intent to treat population. Responders are defined as patients who had a greater than or equal to 50% decrease in mean number urgency incontinence episodes over 24 hours.|||Number of responders|||Number
2684253|NCT01369355|Secondary|Number of Participants in Clinical Remission at Week 44 in the Subset of Participants Who Were Refractory or Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy|Clinical remission at Week 44 was defined as a CDAI score of <150 points in the subset of participants who were refractory or Intolerant to tumor necrosis factor antagonist therapy.|Week 44|The primary efficacy analysis population in this study was randomized participants (ie, participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.|||participants|||Number
2693262|NCT01296360|Secondary|Rate of Subjects Achieving a >4-fold Increase in JEV (Japanese Encephalitis Virus) Neutralizing Antibody Titers at 1 Month After the Booster Dose||1 month|||||||
2684254|NCT01369355|Secondary|Number of Participants With Corticosteroid-free Remission at Week 44|Corticosteroid-free remission at Week 44 was defined as a CDAI score of <150 points without receiving corticosteroids at Week 44.|Week 44|The primary efficacy analysis population in this study was randomized participants (ie, participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.|||participants|||Number
2684255|NCT01369355|Secondary|Number of Participants in Clinical Remission at Week 44 Among Participants in Clinical Remission to Ustekinumab at Week 0 of Maintenance Study|Clinical remission at week 44 was defined as a CDAI score of < 150 points among participants in clinical remission to Ustekinumab at week 0 of maintenance study.|Week 44|Analysis population included all randomized participants after the study was restarted (who were in clinical remission at Week 0 of maintenance study). 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2684256|NCT01369355|Secondary|Number of Participants With Clinical Response at Week 44|Clinical response at Week 44 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points. Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.|Week 44|The primary efficacy analysis population in this study was randomized participants (ie, participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.|||participants|||Number
2684257|NCT01369355|Primary|Number of Participants With Clinical Remission at Week 44|Clinical remission at Week 44 was defined as a Crohn's Disease Activity Index (CDAI) score of <150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). CDAI was assessed by collecting information on 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). A decrease in CDAI over time indicates improvement in disease activity.|Week 44|The primary efficacy analysis population in this study was randomized participants (ie, participants who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.|||participants|||Number
2684258|NCT01369342|Secondary|Number of Participants With CDAI 70 Point Response at Week 3|70-point response is defined as at least 70 points reduction in CDAI score (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 3|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
2684259|NCT01369342|Secondary|Number of Participants With Crohn's Disease Activity Index (CDAI) 70 Point Response at Week 6|70-point response is defined as at least 70 points reduction in CDAI score (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.|Week 6|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
2684260|NCT01369342|Secondary|Number of Participants in Clinical Response at Week 8|Clinical response at Week 8 was defined as a reduction from baseline in the CDAI score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.|Week 8|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
2684261|NCT01369342|Secondary|Number of Participants in Clinical Remission at Week 8|Clinical remission at Week 8 was defined as a Crohn's Disease Activity Index (CDAI) score of <150 points.|Week 8|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
2684262|NCT01369342|Primary|Number of Participants With Clinical Response at Week 6|Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A decrease in CDAI score over time indicates improvement in disease activity.|Week 6|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
2684263|NCT01369329|Secondary|Number of Participants With CDAI 70-point Response at Week 3|70-point response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline and Week 3|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
2684264|NCT01369329|Secondary|Number of Participants With Crohn's Disease Activity Index (CDAI) 70-point Response at Week 6|70-point response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.|Baseline and Week 6|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
2684265|NCT01369329|Secondary|Number of Participants in Clinical Response at Week 8|Clinical response at Week 8 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points. Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.|Baseline and Week 8|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
2684267|NCT01369329|Primary|Number of Participants With Clinical Response at Week 6|Clinical response at Week 6 was defined as a reduction from baseline in the Crohn's Disease Activity Index score of greater than or equal (>=) 100 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.|Baseline and Week 6|Efficacy analyses set included all the participants who were randomized after the study was restarted.|||participants|||Number
2684268|NCT01369225|Other Pre-specified|Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52|The MMSE is a brief 30-point questionnaire test that is used to assess cognition. Scores range from 0 to 30, with higher scores indicating better cognitive state.|Baseline, Week 52|The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
2684269|NCT01369225|Other Pre-specified|Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52|The CDR scale is a dementia staging instrument that tracks the progression of cognitive impairment in the following 6 categories: memory, orientation, judgment and problem solving, involvement in community affairs, home and hobbies, and personal care. The CDR-SB scale is obtained by summing the ratings in each of the 6 categories, ranging from 0 to 18. Higher scores indicate greater disease severity.|Baseline, Week 52|The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
2684270|NCT01369225|Other Pre-specified|Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52|The NPI is an instrument used to assess changes of behavior that have appeared in a defined period of time in subjects with Alzheimer's Disease and other dementias. Twelve behavioral areas are assessed: delusions, apathy, hallucinations, disinhibition, agitation, irritability, depression, aberrant motor behavior, anxiety, nighttime behaviors, euphoria, appetite, and eating changes. The NPI score is based on frequency and severity of specific behaviors within these categories. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.|Baseline, Week 52|The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
2684271|NCT01369225|Other Pre-specified|Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52|The DAD is a functional assessment comprised of 40 items (17 items related to self-care and 23 items involving instrumental activities of daily living). The DAD assessment is scored from 0 to 100; higher scores indicate better function.|Baseline, Week 52|The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
2684272|NCT01369225|Other Pre-specified|Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52|ADAS-Cog is a structured scale that evaluates memory, orientation, attention, reasoning, language and constructional praxis. The ADAS-Cog comprises 11 items that are summed to a total score ranging from 0 to 70, with higher scores indicate greater cognitive impairment.|Baseline, Week 52|The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.|||units on a scale||Standard Deviation|Mean
2684273|NCT01369225|Other Pre-specified|Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer|Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer >=6.64 corresponded to positive ADA category value. The number of participants who tested positive on 1 or more occasions is reported.|Baseline, Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions); n=number of evaluable participants at the specified time point.|||participants|||Number
2684274|NCT01369225|Primary|Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings|Brain MRIs were collected to assess for potential drug-related changes that might have constituted a safety concern. Findings suggestive of either vasogenic edema or intracranial hemorrhage were to be reported as AEs of special circumstance.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).|||participants|||Number
2684275|NCT01369225|Primary|Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)|The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. C-SSRS assesses whether participant experienced the following: completed suicide; suicide attempt; preparatory acts towards imminent suicidal behavior; suicidal ideation; self-injurious behavior, no suicidal intent. The results presented are the number of participants with completed suicide or non-fatal suicide events or behaviors. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).|||participants|||Number
2684276|NCT01369225|Primary|Number of Participants With Abnormal Neurological Examination Findings|Neurological examinations were done to the extent needed to assess the subject for any potential changes in neurological status, as determined by the investigator. Examinations included level of consciousness, speech, cranial nerves, motor, sensory, coordination, gait, and tendon reflexes. Only tests with at least 1 participant abnormality are reported.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).|||participants|||Number
2684426|NCT01368081|Secondary|Change From Baseline in HbA1c|Change from baseline in HbA1c after 52 weeks of treatment|Baseline and 52 weeks|Full analysis set|||percentage of HbA1c||Standard Error|Least Squares Mean
2685588|NCT01358578|Secondary|Maintenance of IGA Mod 2011 0 or 1 Response After 52 Weeks of Treatment for Subjects Who Were IGA Mod 2011 0 or 1 Responders After 12 Weeks of Treatment||52 wks|Full analysis set|||participants who reached goal|||Number
2684277|NCT01369225|Primary|Number of Participants With Abnormal Physical Examination Findings|A full physical examination consisted of an examination of the abdomen, genitourinary and cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal and neurological systems, skin, extremities, head, ears, eyes, nose, throat and thyroid gland. Criteria for abnormal physical findings was based on the investigator's discretion and any new physical examination findings were documented as AEs. Only sites with at least 1 participant abnormality are reported.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).|||participants|||Number
2684278|NCT01369225|Primary|Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings|ECG parameters included PR interval, QRS interval, and QT interval. Criteria for ECG changes meeting potential clinical concern included: PR interval >=300 milliseconds (msec) or >=25% increase when baseline is >200 msec and >=50% increase when baseline is less than or equal to (<=)200 msec; QRS interval >=200 msec or >=50% increase from baseline when baseline is less than or equal to 100 msec and >=25% increase when baseline is >100 msec; and QTcF >=450 msec or >=30 msec increase.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).|||participants|||Number
2684279|NCT01369225|Primary|Number of Participants With Potentially Clinically Important Vital Sign Findings|Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate <40 or >120 beats per minute (bpm); standing pulse rate <40 or >140 bpm; systolic blood pressure (SBP) of more than or equal to (>=)30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP <90 mm Hg, diastolic blood pressure (DBP) >=20 mmHg change from baseline in same posture or DBP <50 mm Hg.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).|||participants|||Number
2684280|NCT01369225|Primary|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern|The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell [RBC] count, RBC morphology, platelet count, white blood cell [WBC] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen [BUN], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy [if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase]); others (coagulation panel, circulating immune complex, and complement activation).|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).|||participants|||Number
2684281|NCT01369225|Primary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.|Baseline up to Week 52|The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).|||participants|||Number
2684282|NCT01369199|Secondary|Absence of Detectable Antiviral Drug-resistance HBV Mutations||End of treatment (up to 48 weeks)||2020-08-31|08/2020||||
2684283|NCT01369199|Secondary|Proportion of Participants With HBV DNA <20 IU/mL||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
2684284|NCT01369199|Secondary|Proportion of Participants With HBV DNA <20 IU/mL||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
2684285|NCT01369199|Secondary|Proportion of Participants With HBV DNA ≤1000 IU/mL||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
2684286|NCT01369199|Secondary|Proportion of Participants With HBV DNA ≤1000 IU/mL||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
2684287|NCT01369199|Secondary|Proportion of Participants With ALT Normalization (Men <30 U/L, Women <20 U/L)||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
2684288|NCT01369199|Secondary|Proportion of Participants With ALT Normalization (Men <30 U/L, Women <20 U/L)||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
2684289|NCT01369199|Secondary|Proportion of Participants With ALT <45 U/L for Men, <30 U/L for Women||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
2684290|NCT01369199|Secondary|Proportion of Participants With Alanine Aminotransferase (ALT) <45 U/L for Men, <30 U/L for Women||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
2684291|NCT01369199|Secondary|Proportion of Participants With HBsAg Seroconversion||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
2684292|NCT01369199|Secondary|Proportion of Participants With HBsAg Seroconversion||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
2684293|NCT01369199|Secondary|Proportion of Participants With HBsAg Loss||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
2684294|NCT01369199|Secondary|Proportion of Participants With HBsAg Loss||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
2684295|NCT01369199|Secondary|Proportion of Participants With HBeAg Seroconversion||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
2684296|NCT01369199|Secondary|Proportion of Participants With HBeAg Seroconversion||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
2684297|NCT01369199|Secondary|Proportion of Participants With HBeAg Loss||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
2684298|NCT01369199|Secondary|Proportion of Participants With HBeAg Loss||End of treatment (up to 48 weeks)||||Proportion of participants||95% Confidence Interval|Number
2684299|NCT01369199|Primary|Incidence of Serious Adverse Events (SAEs) Per Person-Year|The incidence is calculated as the number of SAEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.|From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)||||SAEs per person-year of observation||95% Confidence Interval|Number
2684300|NCT01369199|Primary|Incidence of Adverse Events (AEs) Per Person-Year of Observation|The number of AEs includes both AEs and Serious Adverse Events (SAEs). The incidence is calculated as the number of AEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.|From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)||||Events per person-year of observation||95% Confidence Interval|Number
2684301|NCT01369199|Primary|Proportion of Participants With HBeAg Loss (Lack of Detectable HBeAg) AND HBV DNA ≤1,000 IU/mL|Lack of data was considered to be treatment failure.|End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
2684302|NCT01369108|Primary|Clinical Performance by VAS (Pain Scale)|Sensitivity to cold was measured by applying a cotton pellet soaked with pulp vitality refrigerant spray (Endo Ice, Coltene/ Whaledent, Cuyahoga Falls, OH, USA) to the tooth for three seconds. Sensitivity to biting was measured by having the patient bite on a cotton roll for five seconds. After each test, the subject was asked to place an ''X'' on a 10-mm line labeled ''1'' on the left and ''10'' on the right. Patients were told that a ''10'' represents the worst pain they can imagine (ie, childbirth, major surgery, or kidney stone) and that ''1'' represents no sensation at all.|baseline, 6, 12 and 24 months||||units on a scale|teeth|Standard Deviation|Mean
2684303|NCT01369108|Primary|Clinical Performance by Cvar & Ryge Scores|"Clinical performance reported on 6 parameters as the % of teeth with perfect scores (A rating).~Cvar & Ryge scores measure 6 parameters: Anatomic form (rated A,B= satisfactory, C=unsatisfactory); Color Match (A=match, B=mismatch, but within normal, C=mismatch outside normal); Marginal Adaptation (A=no visible crevice, B=no exposure of dentin, C=defect to enamel-dentine junction, D= fracture, missing); Marginal Discoloration (A=none, B= marginal discoloration, C=marginal discoloration to pulpal direction); Surface Integrity (A=smooth, B=slight rough, C=Pitted, D=fracture)'Secondary caries (A=none, D=present)."|baseline, 6, 12 and 24 months||||percent of teeth|teeth||Number
2684304|NCT01369069|Other Pre-specified|Death|Death from any cause|90 days (+30 days)||||Participants|||Count of Participants
2684305|NCT01369069|Secondary|Stroke Specific Quality of Life (SSQOL)|Stroke Specific Quality of Life. Scores range from 1-5 with higher scores indicating better quality of life|Follow up (Max 164 days)||||score on a scale||Inter-Quartile Range|Median
2684306|NCT01369069|Secondary|Number of Participants With a Favorable Barthel Index|Favorable outcomes for the Barthel Index was defined as a score of 95-100 on the BI at 90 days post randomization. Barthel - Barthel Index for Activities of Daily Living (ADL) assesses functional independence, generally in stroke patients. Scores range from 0-100 with higher scores indicating greater ability to perform activities of daily living.|Follow up (Max 164 days)||||Participants|||Count of Participants
2684307|NCT01369069|Secondary|Number of Participants With a Favorable NIHSS|The NIHSS (National Institutes of Health Stroke Scale) score ranges from 0 to 42, with higher scores indicating greater neurological deficits. A favorable NIHSS was defined as a score of 0 or 1 on the NIHSS at 90 days post randomization.|Follow up (Max 164 days)||||Participants|||Count of Participants
2684308|NCT01369069|Primary|Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL)|Severe hypoglycemia (blood glucose < 40mg/dL) is the primary safety outcome and will be measured during the 72 hour treatment period.|72 hours||||Participants|||Count of Participants
2684309|NCT01369069|Primary|Number of Participants With a Favorable Modified Rankin Scale (Yes/No)|Favorable for the primary efficacy outcome is defined as modified Rankin Scale (mRS) score of 0 in patients with mild stroke (baseline NIHSS 3-7), mRS 0 or 1 in patients with moderate stroke (baseline NIHSS 8-14), and mRS 0, 1 or 2 in patients with severe stroke (baseline NIHSS 15-22) at 90 days with a pre-specified range of acceptable days of 76 -120 days. The mRS is a stroke outcome scale used to assess functional status after stroke. It consists of seven levels (0-6) where 0 indicates no residual symptoms at all, 5 indicates severe disability and 6 indicates death. The person collecting the mRS score was to be blinded to the participant's treatment group assignment.|90 days (-14/+30 days)||||Participants|||Count of Participants
2684310|NCT01369030|Secondary|Change in Overall Patient Satisfaction With Deplin® Using a 9-point Satisfaction Scale|"Mean satisfaction with medication was rated on 1 to 9 point scale, 1 indicating not at all satisfied and 9 as very satisfied."|Baseline to Endpoint (90 days)||||units on a scale||Full Range|Mean
2684311|NCT01369030|Secondary|Proportion of Patients Reporting Difficulty in Daily Functioning Due to Depressive Symptoms||Baseline to Endpoint (90 days)||||percentage of participants|||Number
2684312|NCT01369030|Primary|Change in Depression Severity as Measured by the 9-item Patient Health Questionnaire (PHQ-9)|"The PHQ-9 is a depression scale used to assess brief depression severity by rating symptoms and functional impairment experienced in the last two weeks. The questionnaire contains a total of 9 questions, and each question is scored on a range from 0-3. The minimum value 0 represents not at all, 1 several days, 2 indicates more than half the days, and the maximum value 3 stands for nearly every day. The total possible range is 0-27. The total number of each 0, 1, 2, 3 is added and multiplied by its value (0=0, 1=1, etc.) to produce a total score generated from the subtotal sum. The PHQ-9 total score is interpreted as follows: 0-4 represents minimal depression, 5-9 as mild depression, 10-14 as moderate depression, 15-19 moderately severe depression, and 20-27 severe depression."|Baseline to Endpoint (90 days)|Analyses were performed on the 554 patients who had a baseline PHQ-9>=5 and further analyzed by baseline depression severity groups defined by baseline PHQ-9 scores: 5<=PHQ-9<=9; 10<=PHQ-9<=14; 15<=PHQ-9<=19; and 20<=PHQ-9<=27.|||units on a scale||Standard Deviation|Mean
2684313|NCT01368965|Other Pre-specified|Subject Assessment of Pain|Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region.|During Ulthera treatment||||Average NRS score||Full Range|Mean
2700346|NCT01243320|Primary|Change In Red Blood Count Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||m/uL||95% Confidence Interval|Mean
2684314|NCT01368965|Secondary|Patient Satisfaction Questionnaire|Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at six months (D180) post Ulthera treatment. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.|180 days post-treatment|Data analyzed includes PSQ responses at 180 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied.|||percentage of participants Satisfied|||Number
2684315|NCT01368965|Secondary|Patient Satisfaction Questionnaire|Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.|90 Days post-treatment|Data analyzed includes PSQ responses at 90 days post-treatment assessing subjects' satisfaction with study treatment. Responses were tabulated. Outcomes reported represent the percentage of subjects reporting any satisfaction, i.e., Very Satisfied and Satisfied.|||percentage of participants Satisfied|||Number
2684316|NCT01368965|Secondary|Global Aesthetic Improvement at 180 Days Post-treatment|At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.|180 days post-treatment|"Subjects completing the 180-Day SGAIS = 39; however, the 180-Day PGAIS was not obtained for 2 subjects. PGAIS data are based on n=37.~The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse"|||percentage of participants improved|||Number
2684317|NCT01368965|Secondary|Global Aesthetic Improvement at 90 Days Post-treatment|At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. PGAIS = Physician Global Aesthetic Improvement Scale; SGAIS = Subject Global Aesthetic Improvement Scale.|90 Days post-treatment|"The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse"|||percentage of participants improved|||Number
2684318|NCT01368965|Primary|Change in Overall Lifting and Tightening of Treated Tissue|The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos|90 days post treatment|Masked, qualitative assessment of standardized photographs at 90 days post treatment compared to baseline, could not be completed as images taken at one site were not recovered due to poor data management and staffing issues at the site.||||||
2684319|NCT01368900|Other Pre-specified|Subject Assessment of Pain|Subjects' sensory responses to the treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale, 0-10, where 0 = no pain and 10 = worse pain possible.|Average pain scores reported during study treatment|The subjects' sensory responses to the treatment exposures were recorded for each anatomical region treated, using a validated numeric rating scale of 0-10 with 1 representing no pain and 10 representing the highest degree of pain.|||units on a scale||Full Range|Mean
2684320|NCT01368900|Secondary|Patient Satisfaction Questionnaire at 180 Days Post-treatment|Subject satisfaction determined by scores on a patient satisfaction questionnaire at 180 days post-treatment.|180 days post-treatment|Data analyzed included subjects completing a 180 day visit and a questionnaire assessing treatment satisfaction, comparing pre-treatment and day 180 post-treatment photographic images. Responses were tabulated. 60 of 61 subjects provided responses. One subject's response was missing.|||percentage of participants Satisfied|||Number
2684321|NCT01368900|Secondary|Patient Satisfaction Questionnaire 90 Days Post-treatment|Subject satisfaction determined by scores on a patient satisfaction questionnaire at 90 days post-treatment.|90 days post-treatment|Data analyzed included subjects completing a 90 day visit and a questionnaire assessing treatment satisfaction, comparing pre-treatment and day 90 post-treatment photographic images. Responses were tabulated.|||percentage of participants Satisfied|||Number
2684322|NCT01368900|Secondary|Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 180 Days Post-treatment|"At 180 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse~Any Improvement includes subjects assessed in categories 1-3."|180 days post-treatment|Data analysis was based on participants who completed a Subject Global Aesthetic Improvement scale (SGAIS) and were assessed by a study investigator via completion of a Physician Global Aesthetic Improvement scale (PGAIS)at 180 days post-treatment, per protocol.|||percentage of participants improved|||Number
2684323|NCT01368900|Secondary|Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 90 Days Post-treatment|"At 90 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse~Any Improvement includes subjects assessed in categories 1-3."|90 days post-treatment|Data analysis was based on participants who completed a Subject Global Aesthetic Improvement scale (SGAIS) and were assessed by a study investigator via completion of a Physician Global Aesthetic Improvement scale (PGAIS)at 90 days post-treatment, per protocol.|||percentage of participants improved|||Number
2684324|NCT01368900|Secondary|Improvement in Periorbital Wrinkles and Rhytids Around the Eyes at 60 Days Post-treatment|"At 60 days post-treatment, each site investigator and each subject completed a Global Aesthetic Improvement Scale (GAIS), comparing with pre-treatment photos. The GAIS is 5-point scale (1-5) describing an overall assessment as follows:~= Very Much Improved~= Much Improved~= Improved~= No Change~= Worse~Any Improvement includes subjects assessed in categories 1-3."|60 days post-treatment|At 60 days, the PI and subject completed a GAIS (PGAIS and SGAIS, respectively)for comparison to pre-treatment.|||percentage of participants improved|||Number
2684449|NCT01367860|Secondary|VAS for Leg Pain - 6rd Month|Pain Score for leg pain - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|6th month from surgery|Intention to treat|||units on a scale||Standard Deviation|Mean
2684325|NCT01368900|Primary|Overall Improvement in Periorbital Wrinkles and Rhytids Around the Eyes|Improvement in periorbital skin laxity and rhytids as determined by masked assessor review of photographs at 90days post-treatment compared to baseline.|90 days post-treatment|Primary endpoint: Three masked assessors reviewed pre- and 90 days post-treatment photos, assessing each eye separately. 41 right, 42 left eye photos were found to be usable. Photos excluded had photographic lighting, focus and exposure inconsistencies obscuring key physical details making pre- vs. post-treatment photo comparisons impossible.|||percentage of participants improved|||Number
2684326|NCT01368874|Secondary|L'Oreal Photographic Scale 180 Days Post-treatment|"At 180 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:~Horizontal neck folds (Grades 0-6)~Neck sagging (Grades 0-7);~Texture (Female grades 0-5; male grades 0-7);~Ptosis (Female grades 0-5; males grades 0-7)."|180 Days post-treatment||||units on a scale||Full Range|Mean
2684327|NCT01368874|Secondary|L'Oreal Photographic Scale 90 Days Post-treatment|"At 90 days post-treatment, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:~Horizontal neck folds (Grades 0-6)~Neck sagging (Grades 0-7);~Texture (Female grades 0-5; male grades 0-7);~Ptosis (Female grades 0-5; males grades 0-7)."|90 Days post-treatment||||units on a scale||Full Range|Mean
2684328|NCT01368874|Secondary|L'Oreal Photographic Scale Baseline|"At baseline, the Principal Investigator (PI) assessed the subjects' horizontal neck folds, neck sagging, and texture and ptosis changes using the L'Oreal Photographic Scales. The L'Oreal scales include the following categories, with a higher grade denoting an increased severity in each category:~Horizontal neck folds (Grades 0-6)~Neck sagging (Grades 0-7);~Texture (Female grades 0-5; male grades 0-7);~Ptosis (Female grades 0-5; males grades 0-7)."|Baseline||||units on a scale||Full Range|Mean
2684329|NCT01368874|Secondary|Patient Satisfaction Questionnaire 180 Days Post-treatment|Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 180 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the ares treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 180 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 180 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included.|180 days post-treatment||||Percentage of participants|||Number
2684330|NCT01368874|Secondary|Patient Satisfaction 90 Days Post-treatment|Patient satisfaction was determined by scores on a patient satisfaction questionnaire (PSQ) completed at 90 days post-treatment. Subjects indicated on a PSQ whether they saw improvement in the areas treated, i.e., providing a Yes/No response, and how satisfied they were with their Ulthera treatment, i.e., Very Satisfied, Satisfied, Dissatisfied, Very Dissatisfied. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment, comparing pre-treatment and 90 day post-treatment photos. Proportions of subjects reporting Improvement, and Very Satisfied and Satisfied are included.|90 Days post-treatment||||Percentage of participants|||Number
2684331|NCT01368874|Secondary|Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity , as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.|"At 180 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse Any Improvement includes participants assessed in categories 1-3"|180 days post-treatment|At 180 days post-treatment, the PI and subject completed a Global Aesthetic Improvement Scale (PGAIS and SGAIS, respectively)for comparison to pre-treatment.|||percentage of participants improved|||Number
2684332|NCT01368874|Other Pre-specified|Subjects' Assessment of Pain|Subjects' sensory response to the Ulthera treatment exposures were recorded for each anatomical region treated using a validated Numeric Rating Scale (0-10), with 0 representing no pain and 10 representing the worst pain possible.|During Ulthera treatment||||units on a scale||Full Range|Mean
2684333|NCT01368874|Primary|Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity - RE-ANALYZED GROUP|"Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis.~A data set of 42 of the 61 participants were re-analyzed. Data were removed for 19 participants whose pre-treatment and/or post-treatment photos were of poor photo quality, i.e., poor lighting, poor focus, poor positioning, creating the potential for biasing the masked assessment results."|90 Days post-treatment||||participants|||Number
2684334|NCT01368874|Secondary|Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.|"At 90 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse Any Improvement includes participants assessed in categories 1-3"|90 days post-treatment|At 90 days post-treatment, the PI and subject completed a Global Aesthetic Improvement Scale (PGAIS and SGAIS, respectively)for comparison to pre-treatment.|||percentage of participants improved|||Number
2684350|NCT01368614|Secondary|Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Nocturnal O2 Saturation|Measurement of overnight oxygen saturation as measured by percentage of oxygen saturation (SpO2)|Screening & 6 weeks|"6 participants withdrew from the study and therefore did not provide values at week 6.~1 Participant did not have scorable data from the baseline PSG to calculate this measure."|||percentage of oxygen saturation (SpO2)||Standard Deviation|Mean
2684335|NCT01368874|Secondary|Improvement in Overall Lifting and Tightening of Jowl and/or Neck Laxity, as Assessed by the Principal Investigator (PI) and the Subject Using the Global Aesthetic Improvement Scale, i.e., PGAIS and SGAIS, Respectively.|"At 60 days post-treatment, a PGAIS and SGAIS were completed based on a live assessment of the subject and a photographic assessment comparing post-treatment photos to baseline photos, to assess overall aesthetic improvement. The GAIS is a 5-point scale (1-5) describing an overall assessment as follows:~- Very Much Improved~- Much Improved~- Improved~- No Change~- Worse Any Improvement includes participants assessed in categories 1-3"|60 days post-treatment|At 60 days post-treatment, the PI and subject completed a Global Aesthetic Improvement Scale (PGAIS and SGAIS, respectively)for comparison to pre-treatment.|||percentage of participants improved|||Number
2684336|NCT01368874|Primary|Improvement in Overall Lifting and Tightening of the Jowls and/or Neck Laxity|Improvement in overall lifting and tightening of skin as determined by masked, qualitative assessment of photographs at 90 days post-treatment compared to baseline. Efficacy was based on the number of treated subjects assessed as improved in skin laxity, horizontal neck folds, neck sagging, texture and/or ptosis.|90 Days post-treatment||||participants|||Number
2684337|NCT01368835|Other Pre-specified|Subject Assessment of Pain|Subject assessment of pain using a validated Numeric Rating Scale (NRS), 0-10, where 0 = no pain and 10=worse pain possible. Subjects' sensory responses to the treatment exposures were recorded using the NRS for each anatomical region.|During Ulthera study treatment|Evaluable subjects, i.e., n=70, who received an Ulthera treatment and for whom an NRS was completed.|||Average NRS score||Full Range|Mean
2684338|NCT01368835|Secondary|Patient Satisfaction Questionnaire|Subjects indicated whether they saw improvement, i.e., providing a Yes/No response, in face and neck characteristics at three months (D90) post Ulthera treatment. Pre-treatment and Day 90 post-treatment photographs were available for viewing during the assessment. Subjects also had a mirror in hand for real time assessment. Subjects' Yes/No responses were tabulated.|90D|The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available.|||percentage of participants improved|||Number
2684339|NCT01368835|Secondary|Change in Submental and Neck Skin Laxity by Quantitative Analysis|The percentage of participants assessed as having an improvement in tissue lift, i.e., >20mm2 in submental and neck skin laxity, at 90 Days post-treatment compared to baseline based on quantitative analysis.|90D|The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available, i.e., evaluable participants.|||percentage of participants improved|||Number
2684340|NCT01368835|Primary|Change in Overall Lifting and Tightening of Treated Tissue on the Lower Face and Submental Regions.|The percentage of participants assessed to have improvement in skin laxity, i.e., lifted and tightened skin in the areas treated with the Ulthera System, as determined by three masked assessors comparing pre-treatment and 90-days post-treatment photos from 70 subjects who returned for their 90-day follow-up visit.|90D|The number of participants who received an Ulthera treatment and for whom pre-treatment and 90-day post-treatment photos were available, i.e., evaluable participants, for a masked assessment.|||percentage of participants improved|||Number
2684341|NCT01368809|Secondary|Postoperative Pain|"Postoperative pain measured using a Verbal Rating Scale (VRS) at post-anesthesia care unit (PACU), (90 minutes after arriving).~Postoperative pain VRS scores: 0 = none pain to 10 = intolerable pain."|one day||||Scores on a scale||Standard Deviation|Mean
2684342|NCT01368809|Secondary|Incidence of Nausea and Vomiting|Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) at PACU (post-anesthesia care unit.|1 day||||participants|||Number
2684343|NCT01368809|Primary|Incidence of Coughing|during the perioperative period (insertion of an LMA device, maintenance of anesthesia, and emergence from general anesthesia) for ambulatory surgery procedures.|one day||||participants|||Number
2684344|NCT01368653|Secondary|Prolonged Abstinence|This outcome measures whether regular smoking (7 days in a row) occurred between the 4th and 10th weeks of the quit attempt.|10 weeks||||participants|||Number
2684345|NCT01368653|Secondary|Mediators of Treatment Effects|Emotional, mental, and behavioral measures that may help explain treatment effects on tobacco use outcomes will be assessed intensively in the three weeks leading up to a quit attempt and the first week of a quit attempt to examine mediators of the first phase treatment. Additional analyses of reports of emotions, thoughts, and behaviors will explore mediators of non-nicotine cigarette effects on smoking. These measures will be analyzed to see if treatment affects them and if they predict smoking behavior.|1 week post-quit and 6 weeks post-quit|||||||
2684346|NCT01368653|Secondary|10-week Abstinence|This captures whether any tobacco use occurred in the past 7 days at the 10-week follow up (i.e., whether any tobacco use occurred in the 10th week of the quit attempt), as reported by participants in a timeline follow-back telephone interview and confirmed by a follow-up expired carbon monoxide reading less than or equal to 8 parts per million.|10 weeks||||participants|||Number
2684347|NCT01368653|Primary|4-week Abstinence|7-day point prevalence abstinence captures whether participants have used tobacco in the past 7 days at the 4-week post-quit follow-up (i.e., whether any tobacco use occurred in the 4th week of the quit attempt).|4 weeks||||participants|||Number
2684348|NCT01368614|Secondary|Number of Participants With Need for Continued Oxygen Supplementation|Some users enrolled into the study required supplemental oxygen at different times during the day: at rest, during exertion and at night. The need for supplemental oxygen was compared at baseline and at 6 weeks.|Screening & 6 weeks||||Participants|||Count of Participants
2684349|NCT01368614|Secondary|Reaction Time (Psychomotor Vigilance Test-PVT)|To measure trends of vigilance between the baseline screening assessment and the 6 week follow up visit comparing the three Arms/Groups. This measured how quickly participants reacted to visual stimulus. Reaction time is the latency at which the participant reacts to a visual stimulus > 100 ms.|Screening & 6 weeks|"participant from the AVAPS-AE Arm/Group did not complete the baseline screening PVT.~participants from the Omnilab Advanced BIPAP Arm/Group did not complete the 6 week follow up PVT.~participants from the Omnilab Advanced CPAP Arm/Group did not complete the 6 week follow up PVT."|||milliseconds||Standard Deviation|Median
2684366|NCT01368536|Secondary|Percentage of Patients Achieving Blood Pressure Control After Treatment|Patient with blood pressure control is defined as patients achieving MSSBP <130 mmHg and MSDBP <80 mmHg.|12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
2684351|NCT01368614|Secondary|Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study)- Arousal and Awakening Indices|The arousal index is measured by the average number of arousals or awakenings a participant has over an hour of sleep.|Screening & 6 weeks|"6 participants withdrew from the study and therefore did not provide values at week 6.~1 Participant did not have scorable data from the baseline PSG to calculate this measure."|||arousals per hour||Standard Deviation|Mean
2684352|NCT01368614|Secondary|Duration and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Sleep Efficiency|Duration, efficiency and quality of sleepiness are measured by a number of different parameters. Sleep efficiency is measured by the total time a participant is spent asleep.|Screening & 6 weeks|"6 participants withdrew from the study and therefore did not provide values at week 6.~1 Participant did not have scorable data from the baseline PSG to calculate this measure."|||percentage of time spent in that stage||Standard Deviation|Mean
2684353|NCT01368614|Secondary|Duration, Efficiency and Quality of Sleep and Sleepiness (Derived From Sleep Study) - Duration|Duration, efficiency and quality of sleepiness are measured by a number of different parameters. Total sleep time in each stage provides the average amount of time a participant was in that stage of sleep. This includes Stage 1, Stage 2, Stage 3/4, and Rapid Eye Movement (REM) sleep.|Screening & 6 weeks|"6 participants withdrew from the study and therefore did not provide values at week 6.~1 Participant did not have scorable data from the baseline PSG to calculate this measure."|||percentage of time spent in that stage||Standard Deviation|Mean
2684354|NCT01368614|Secondary|Nocturnal Transcutaneous Capnography (TcC02)|"Nocturnal Transcutaneous Capnography is a non-invasive monitoring tool to measure ventilation over the night.~."|Screening & 6 weeks|This measure was not a standard practice of the sleep scoring company and was not done.||||||
2684355|NCT01368614|Secondary|Room Air Sp02 Assessment Via Pulse Oximetry|Oxygen saturation measurements as determined by pulse oximetry|Screening & 6 weeks|6 participants withdrew from the study and therefore did not provide values at week 6.|||percentage of oxygen saturation (SpO2)||Standard Deviation|Mean
2684356|NCT01368614|Secondary|Actigraphy|Actigraphy is a method of measuring activity and sleep which is achieved by wearing a small watch-like device for an extended period of time. The data is intended to provide an objective measure of physical activity and sleep / week patterns during pre / post sleep studies and throughout the 6 weeks of home use.|Screening & 6 weeks|Participants were asked to wear an actiwatch to measure actigraphy. Actigraphy was reviewed as part of the study however a detailed analysis was not conducted because the data was to variable.||||||
2684357|NCT01368614|Secondary|Ventilator Adherence - Days Used|Average number of days used per week|6 weeks|6 participants withdrew from the study and therefore did not provide values at week 6.|||days per week||Standard Deviation|Mean
2684358|NCT01368614|Secondary|Ventilator Adherence - Average Hours|The average number of hours ventilator was used per each day used.|6 weeks|6 participants withdrew from the study and therefore did not provide values at week 6.|||Hours per day||Standard Deviation|Mean
2684359|NCT01368614|Secondary|Severe Respiratory Insufficiency Questionnaire (SRIQ)|The SRIQ is a 49 question survey. This survey asks questions about the past week. It is answered on a scale of -2 to 2 and converted to 1 to 5, 1 is completely untrue and 5 is always true. The questionnaire is broken down into 7 sections when scoring: respiratory complaints, physical functioning, attendant systems and sleep, social relationships, anxiety, psychological well-being and social functioning. Once each scale score is calculated. The average score can be calculated by taking the mean of the subscales. This process of transformation produces a score between 0 and 100 with higher values indicating a better health-related quality of life according to content of the scale.|Screening & 6 weeks|6 participants withdrew from the study and therefore did not provide values at week 6.|||units on a scale||Standard Deviation|Mean
2684360|NCT01368614|Secondary|Epworth Sleepiness Scale|Epworth Sleepiness scale is a measure of daytime sleepiness. It is a series of 8 questions answered on a scale of 0 to 3, 0 being no chance of dozing and 3 being a high chance of dozing. The range of the scale is 0 to 24. The higher the total score, the higher the chance of falling asleep.|Screening & 6 weeks|"6 participants withdrew from the study and therefore did not provide values at week 6.~1 participant did not complete the ESS at the end of the study."|||units on a scale||Standard Deviation|Mean
2684361|NCT01368614|Secondary|Apnea Hypopnea Index (AHI)|The AHI is the number of apneas and hypopneas per hour of sleep. It will be evaluated during the screening sleep study and the 6 week follow up sleep study. AHI less than 5 is considered normal. For an Apnea-Hypopnea Index (or AHI) from 5 to 15 denotes mild sleep apnea. Fifteen to 30 is moderate, while a greater than 30 AHI is considered severe.|Screening & 6 weeks|"6 participants withdrew from the study and therefore did not provide values at week 6.~1 Participant did not have scorable data from the baseline PSG to calculate this measure."|||events per hour||Standard Deviation|Mean
2684362|NCT01368614|Secondary|Daytime Partial Pressure of Oxygen in Arterial Blood(Pa02)|Daytime Pa02 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks.|Screening & 6 weeks|6 participants withdrew from the study and therefore did not provide values at week 6.|||mmHg||Standard Deviation|Mean
2684363|NCT01368614|Primary|Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)|Daytime PaCO2 measurements will be assessed for all randomized patients to each mode of ventilation therapy (AVAPS-AE, bilevel PSV, CPAP) after 6 weeks.|Screening & 6 weeks|6 participants withdrew from the study and therefore did not provide values at week 6.|||mmHg||Standard Deviation|Mean
2684364|NCT01368562|Primary|Number of Participants With Opioid Induced Side Effects|Opioid induced side effects included nausea, myoclonus, mental clouding (confusional state), vomiting, sedation, pruritus, sweating (hyperhidrosis), constipation, and urinary retention. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.|From start of treatment until end of study (up to maximum 3.4 years)|All enrolled participants who provided a signed and dated written ICF.|||Participants|||Count of Participants
2684365|NCT01368536|Secondary|Number of Patients With Adverse Events, Serious Adverse Events and Death to Assess Safety and Tolerability of Treatment With Valturna and Chlorthalidone or Valturna and Amlodipine Versus Valturna Alone||12 weeks|Safety Set — Consists of all patients who received at least one dose of the double-blind study drug. Patients were analyzed according to the treatment that they received.|||Participants|||Number
2684368|NCT01368536|Secondary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) After 12 Weeks of Treatment|Sitting blood pressure (BP) was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, DBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|Baseline, 12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
2684369|NCT01368536|Secondary|Change From Baseline in MSSBP After 12 Weeks of Treatment Ending With Between the Valturna + Chlorthalidone Combination and Valturna Alone|Sitting BP was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|Baseline, 12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
2684370|NCT01368536|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) After 12 Weeks of Treatment Ending With the Combination of Valturna and Amlodipine Versus Valturna Alone|Sitting BP was measured at trough (24 hours ± 3 hours postdose) and recorded at all study visits. At the first study visit, the patient had his/her BP measured in both arms; the arm in which the highest sitting DBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.|Baseline, 12 weeks|The study was terminated and consequentially was underpowered for adequate statistical analysis||||||
2684371|NCT01368497|Secondary|Tanner Stages of Pubic Hair Growth|"The Tanner Stage questionnaire is only completed by participants 8 years of age and older. The copyrighted form includes pictures and descriptions. Participants selected the picture closest to their self-perceived pubic hair growth.~Boys and girls: I-prepubertal (no pubic hair at all); II-sparse growth of long, slightly pigmented hair, straight or curled, at base of penis or along labia; III: darker, coarser and more curled hair, spreading sparsely over junction of pubes; IV- hair adult in type, but covering smaller area than in adult; V-adult in type and quantity.~There is no better or worse outcome. They are self-assessed descriptive measures of physical growth."|End of follow-up (up to 96 weeks)||||Participants|||Count of Participants
2684372|NCT01368497|Secondary|Tanner Stages of Pubic Hair Growth|"The Tanner Stage questionnaire is only completed by participants 8 years of age and older. The copyrighted form includes pictures and descriptions. Participants selected the picture closest to their self-perceived pubic hair growth.~Boys and girls: I-prepubertal (no pubic hair at all); II-sparse growth of long, slightly pigmented hair, straight or curled, at base of penis or along labia; III: darker, coarser and more curled hair, spreading sparsely over junction of pubes; IV- hair adult in type, but covering smaller area than in adult; V-adult in type and quantity.~There is no better or worse outcome. They are self-assessed descriptive measures of physical growth."|End of treatment (up to 48 weeks)||||Participants|||Count of Participants
2684373|NCT01368497|Secondary|Tanner Stages of Physical Growth|"The Tanner Stage questionnaire is only completed by participants 8 years of age and older. The copyrighted form includes pictures and descriptions. Girls selected the picture closest to their self-perceived breast growth from among 5 stages of breast growth and boys did the same for testes, scrotum, and penis growth.~Boys: I-prepubertal; II-enlargement of scrotum and testes; III-enlargement of the penis and further growth of testes; IV- increased size of penis with growth in breadth and development of glans, testes, and scrotum larger, scrotum skin darker; V- adult genitalia.~Girls: I-prepubertal; II-breast bud stage with the elevation of breast and papilla and enlargement of the areola; III-further enlargement of breast and areola, no separation of their contour; IV-areola and papilla form a secondary mound above the level of the breast; V: mature adult stage.~There is no better or worse outcome. They are self-assessed descriptive measures of physical growth."|End of follow-up (up to 96 weeks)||||Participants|||Count of Participants
2684374|NCT01368497|Secondary|Tanner Stages of Physical Growth|"The Tanner Stage questionnaire is only completed by participants 8 years of age and older. The copyrighted form includes pictures and descriptions. Girls selected the picture closest to their self-perceived breast growth from among 5 stages of breast growth and boys did the same for testes, scrotum, and penis growth.~Boys: I-prepubertal; II-enlargement of scrotum and testes; III-enlargement of the penis and further growth of testes; IV- increased size of penis with growth in breadth and development of glans, testes, and scrotum larger, scrotum skin darker; V- adult genitalia.~Girls: I-prepubertal; II-breast bud stage with the elevation of breast and papilla and enlargement of the areola; III-further enlargement of breast and areola, no separation of their contour; IV-areola and papilla form a secondary mound above the level of the breast; V: mature adult stage.~There is no better or worse outcome. They are self-assessed descriptive measures of physical growth."|End of treatment (up to 48 weeks)||||Participants|||Count of Participants
2684375|NCT01368497|Secondary|Growth Measures: Z-scores Weight, Height, and Body Mass Index|A child's Z-score is the number of standard deviations that the child is from the average of children of the same sex and age from a reference population. The reference population is provided in the 2000 Centers for Disease Control and Prevention (CDC) growth charts. Positive Z scores mean the growth measure (weight, height, or body mass index) is above the average, negative Z scores mean the growth measure is below the average.|End of follow-up (up to 96 weeks)||||Z-score||95% Confidence Interval|Mean
2684376|NCT01368497|Secondary|Growth Measures: Z-scores Weight, Height, and Body Mass Index|A child's Z-score is the number of standard deviations that the child is from the average of children of the same sex and age from a reference population. The reference population is provided in the 2000 Centers for Disease Control and Prevention (CDC) growth charts. Positive Z scores mean the growth measure (weight, height, or body mass index) is above the average, negative Z scores mean the growth measure is below the average.|End of treatment (up to 48 weeks)||||Z-score||95% Confidence Interval|Mean
2684392|NCT01368497|Primary|Incidence of Serious Adverse Events (SAEs) Per Person-Year|The incidence is calculated as the number of SAEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.|From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)||||SAEs per person-year of observation||95% Confidence Interval|Number
2684393|NCT01368497|Primary|Incidence of Adverse Events (AEs) Per Person-Year|The number of AEs includes both AEs and Serious Adverse Events (SAEs). The incidence is calculated as the number of AEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.|From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)||||AEs per person-year of observation||95% Confidence Interval|Number
2684394|NCT01368497|Primary|Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss & Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels ≤1,000 International Units (IU) Per Milliliter (mL)||End of follow-up (up to 96 weeks)||||Proportion of participants||95% Confidence Interval|Number
2684395|NCT01368432|Secondary|Mini Mental Status Exam (MMSE)|"This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal).~A score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable."|At 12 weeks||||units on a scale||Standard Deviation|Mean
2684396|NCT01368432|Secondary|Mini Mental Status Exam (MMSE)|"This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal).~A score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable."|At baseline||||units on a scale||Standard Deviation|Mean
2684397|NCT01368432|Secondary|Disability Rating Scale (DRS)|"This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable.~Scores range from 0 (normal) and 29 (extreme vegetative state)."|At 12 weeks||||units on a scale||Standard Deviation|Mean
2684398|NCT01368432|Secondary|Disability Rating Scale (DRS)|"This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable.~Scores range from 0 (normal) and 29 (extreme vegetative state)."|At baseline||||units on a scale||Standard Deviation|Mean
2684399|NCT01368432|Secondary|Quality of Life (QWL)|"This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale.~Scores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable."|At 12 weeks||||units on a scale||Standard Deviation|Mean
2684400|NCT01368432|Secondary|Quality of Life (QWL)|"This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale.~Scores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable."|At baseline||||units on a scale||Standard Deviation|Mean
2684401|NCT01368432|Secondary|Satisfaction With Life (SWL)|"This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale.~The scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life).~It is used as continuous variable."|12 weeks||||units on a scale||Standard Deviation|Mean
2684402|NCT01368432|Secondary|Satisfaction With Life (SWL)|"This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale.~The scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life).~It is used as continuous variable."|baseline||||units on a scale||Standard Deviation|Mean
2684403|NCT01368432|Secondary|Clinical Anxiety Scale (CAS)|"This outcome measure is assessing the participant's anxiety as assessed by the CAS.~The scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable."|12 weeks||||units on a scale||Standard Deviation|Mean
2684404|NCT01368432|Secondary|Clinical Anxiety Scale (CAS)|"This outcome measure is assessing the participant's anxiety as assessed by the CAS.~The scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable."|Baseline||||units on a scale||Standard Deviation|Mean
2684405|NCT01368432|Secondary|Clinical Global Impression (CGI)- Improvement|"This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator.~The scores range from 1-7~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse"|at 12 weeks||||units on a scale||Standard Deviation|Mean
2684406|NCT01368432|Secondary|Clinical Global Impression (CGI) - Severity at Baseline|"This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator. Scores range from 1-7~= Normal—not at all ill~= Borderline mentally ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill patients."|Baseline||||units on a scale||Standard Deviation|Mean
2684407|NCT01368432|Primary|Montgomery-Asberg Depression Rating Scale (MADRS)|"This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.~0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; >34 - severe depression.~In this study the score was used as a continuous variable."|MADRS score at 12 weeks||||units on a scale||Standard Deviation|Mean
2684408|NCT01368432|Primary|Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline|"This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.~0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; >34 - severe depression.~In this study the score was used as a continuous variable."|MADRS score at baseline||||units on a scale||Standard Deviation|Mean
2684409|NCT01368406|Primary|Change in Weight From Baseline to Endpoint|All patients were weighed in the morning, on the same scale, without shoes, with the individuals wearing light clothes.Measures were collected by the same investigator in all assessments.|baseline, 3-month||||kg||95% Confidence Interval|Mean
2685589|NCT01358578|Secondary|Maintenance of PASI 75 Response at Week 52 for Patients Who Were PASI 75 Responders at Week 12 (Non-responder Imputation)||52 wks|Full analysis set|||participants who reached goal|||Number
2684410|NCT01368276|Secondary|Durable Response Rate|"Durable response rate is defined as the percentage of participants with a complete response (CR) or partial response (PR) assessed by the investigator, initiating at any time while receiving talimogene laherparepvec or GM-CSF therapy on the 005/05 or the 005/05-E study and maintained continuously for at least 6 months from response initiation. This reflects all new sites of disease as well as disease sites identified at baseline.~Disease assessments were performed at the beginning of each treatment cycle in accordance with modified World Health Organization criteria.~CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline."|From randomization in study 005/05 until the data-cut-off date for the extension period of 08 August 2014; median treatment duration for 005/05 and 005/05-E studies combined was 88 weeks for talimogene laherparepvec and 100 weeks for GM-CSF.|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2684411|NCT01368276|Secondary|Objective Response Rate|"Objective response rate was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) assessed by the investigator. Best overall response for a patient is the best overall response observed across all time points and is cumulative (ie, includes responses during the parent study 005/05 and during Study 005/05-E).~Disease assessments were performed at the beginning of each treatment cycle and assessed in accordance with modified World Health Organization criteria.~CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline."|From randomization in study 005/05 until the data-cut-off date for the extension period of 08 August 2014; median treatment duration for 005/05 and 005/05-E studies combined was 88 weeks for talimogene laherparepvec and 100 weeks for GM-CSF.|The full analysis set for the extension study is defined as all participants who received at least one dose of extension treatment.|||percentage of participants||95% Confidence Interval|Number
2684412|NCT01368276|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs)|"AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 based on the following guideline:~Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE.~Treatment-related AE refers to AEs that have possible or probable relation to study treatment as determined by the investigator.~A serious AE is one that meets one or more of the following criteria/outcomes:~Results in death.~Is life-threatening.~Requires inpatient hospitalization or prolongation of existing hospitalization.~Results in persistent or significant disability/incapacity.~Is a congenital anomaly/birth defect.~Is an important medical event."|From first administration of study drug in the extension period until 30 days after last dose. Median duration of treatment was 50 weeks in the GM-CSF group and 36 weeks in the talimogene laherparepvec group.|Safety population (randomized participants who received at least one dose of extension treatment).|||participants|||Number
2684413|NCT01368263|Secondary|PEPI-0 Rate in Patients Whose Estradiol is Fully Suppressed (< or = 15 pg/mL) and Tumor Ki67 Level is 10% or Less||16 weeks|(1) of the participants in Group 1 had an inconclusive PEPI score at week 16 and was not evaluable. (1) of the participants in Group 1 did not have surgery and was not evaluable. Participants in Group 2 and Group 3 were not evaluable for this outcome as the estradiol and Ki67 levels were above outcome specified levels.|||percentage of participants|||Number
2684414|NCT01368263|Secondary|Preoperative Endocrine Prognostic Index Score (PEPI Score)|To obtain the PEPI score, risk points for relapse-free survival (RFS) and breast cancer-specific survival (BCSS) are assigned depending on the hazard ratio (HR) from the multivariable analysis. The total PEPI score assigned to each patient is the sum of the risk points derived from the pT stage, pN stage, Ki67 level, and estrogen receptor status of the surgical specimen. A HR in the range of 1 to 2 receives one risk point; a HR in the 2 to 2.5 range, two risk points; a HR greater than 2.5, three risk points. The total risk point score for each patient is the sum of all the risk points accumulated from the four factors in the model, ranges from 0 (best possible outcome) to 12 (worst possible outcome).|At time of definitive surgery|2 participants in Group 1 did not have a PEPI score at time of surgery as (1) participant did not have nodal dissection and (1) did not have surgery. Both participants in Group 2 and Group 3 did not have surgery study tissue collected|||participants|||Number
2684415|NCT01368263|Secondary|Relationship Between Pretreatment FFNP-PET Standard Uptake Value (SUV) and 4-week Post-treatment Ki-67||Baseline and 4 weeks post-treatment|This outcome was not analyzed due to funding issues.||||||
2684416|NCT01368263|Primary|Acceptability of Management With Surgical Oophorectomy/Continued LHRH With Continued Oral Endocrine Therapy and no Chemotherapy|Proportion of patients with a PEPI score of 0 and pathological stage 1 who choose to forego chemotherapy.|6 months post neoadjuvant endocrine therapy and surgery|None of the participants had a PEPI score and 0 and pathological stage 1.||||||
2684417|NCT01368263|Primary|Pathologic Complete Response (CR) Rate|"In patients with Ki67 >10% and <= 15 pg/ml at 4 weeks.~The pCR rate for neo-adjuvant chemotherapy is defined as 100 times the number of eligible patients with no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary or sentinel lymph nodes divided by the total number of eligible patients who received neo-adjuvant chemotherapy."|1 month|There were no evaluable participants to analyze in Group 1, 2, or 3. No participants met the criteria for Ki67 >10% and estradiol levels of <= 15 pg/ml at 4 weeks.||||||
2684418|NCT01368211|Secondary|Change in Maximum Amplitude at 24-hours Post-transfusion|Thromboelastography parameter: Pre- to post-transfusional modification in Maximum Amplitude at 24-hours post-transfusion|pre-transfusion, 24-hour post transfusion||||mm||Standard Deviation|Mean
2684419|NCT01368211|Primary|Change in Maximum Amplitude at 1-hour Post-transfusion|Thromboelastography (TEG) Parameter: Pre- to post-transfusional modification of Maximum Amplitude at 1-hour post-transfusion|pre-transfusion, 1-hour post transfusion||||mm||Standard Deviation|Mean
2684420|NCT01368185|Secondary|Systolic Blood Pressure (SBP)|SBP at baseline and month 3.|Baseline and Month 3||||mmHg||Standard Deviation|Mean
2684421|NCT01368185|Secondary|Diastolic Blood Pressure (DBP)|DBP at baseline and month 3.|Baseline and Month 3||||mmHg||Standard Deviation|Mean
2684422|NCT01368185|Secondary|The Percentage of Patients With Hyperuricemia|Hyperuricemia was defined as SUA >6.6mg/dL in females and >7.7mg/dL in males.|Baseline and Month 3||||percent of participants|||Number
2684427|NCT01368042|Secondary|Change Per Month From Baseline to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL Per Month)|PTH levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. Linear models based on Generalized Estimating Equations (GEE) were used to assess the effect of time on change from enrollment (at least 1 month after starting treatment with paricalcitol iv) through 3 months post-enrollment and 6 months post-enrollment.|Enrollment, 3 months post-enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.|||pg/mL per month||95% Confidence Interval|Mean
2684428|NCT01368042|Secondary|Change From Enrollment to 6 Months in Parathyroid Hormone (PTH) Levels (pg/mL)|PTH levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months|All enrolled participants with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up).|||pg/mL||Standard Deviation|Mean
2684429|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Calcium-Phosphorous (Ca×P) Product Levels (mg˄2/dL˄2)|Ca×P product levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.|||mg˄2/dL˄2||Standard Deviation|Mean
2684430|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Phosphorous Levels (mg/dL)|Phosphorous levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.|||mg/dL||Standard Deviation|Mean
2684431|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Calcium Levels (mg/dL)|Calcium levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.|||mg/dL||Standard Deviation|Mean
2684432|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Creatinine Levels (mg/dL)|Creatinine levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.|||mg/dL||Standard Deviation|Mean
2684433|NCT01368042|Secondary|Change From Enrollment to 6 Months Post-enrollment in Urea Levels (mg/dL)|Urea levels were recorded at each study visit prior to hemodialysis according to routine clinical practice and at the discretion of the physician. The change from enrollment (at least 1 month after starting treatment with paricalcitol iv) to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit value minus the enrollment value.|Enrollment, 6 months post-enrollment|All participants in the enrolled population with available data at the study timepoints, regardless of whether or not they completed the study (i.e., the 6-month post-enrollment follow-up). Of the 265 participants enrolled, 11 were considered to have protocol deviations and excluded; therefore, 254 participants were included in the study analyses.|||mg/dL||Standard Deviation|Mean
2684434|NCT01368042|Primary|Change Per Month From Baseline to 6 Months Post-enrollment on the 8 Scales of the RAND 36-Item Health Survey|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, bodily pain, general health perception, health change). Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the enrollment and post-enrollment visits was calculated as the visit score minus the baseline score. Linear models based on Generalized Estimating Equations (GEE) were used to assess the effect of time on change from baseline through enrollment, 3 months post-enrollment, and 6 months post-enrollment.|Baseline, enrollment, 3 months post-enrollment, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale/month||95% Confidence Interval|Mean
2684435|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Health Change' Item Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes a single question pertaining to the participant's health change over the last year. The scores range from 0 to 100, with 100: much better than 1 year ago; 75: somewhat better than 1 year ago; 50: about the same; 25: somewhat worse than 1 year ago; 0: much worse than 1 year ago. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale||Standard Deviation|Mean
2684436|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'General Health Perceptions' Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including general health perceptions. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale||Standard Deviation|Mean
2684437|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Bodily Pain' Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including bodily pain. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale||Standard Deviation|Mean
2684438|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Social Functioning' Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including social functioning. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale||Standard Deviation|Mean
2684439|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Emotional Well-Being' Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including emotional well-being. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale||Standard Deviation|Mean
2684440|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Energy/Fatigue' Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including energy/fatigue. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale||Standard Deviation|Mean
2684450|NCT01367860|Secondary|VAS for Leg Pain - 3rd Month|Pain Score for leg pain - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|3rd month from surgery||||units on a scale||Standard Deviation|Mean
2684451|NCT01367860|Secondary|VAS for Leg Pain - 1st Month|Pain Score for leg pain - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|1st month from surgery||||units on a scale||Standard Deviation|Mean
2687710|NCT01339897|Secondary|Pharmacokinetics of N6022 Over 7 Days|Analysis of N6022 AUC0-tau values from Study Day 7|Day 7, 24 hours|N6022 AUC0-tau values from Study Day 7|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2684441|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Emotional Problems' Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including role limitations due to emotional problems. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale||Standard Deviation|Mean
2684442|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Role Limitations Due to Physical Health' Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including role limitations due to physical health. The scores for each scale range from 0 to 100, with 0 representing the worst possible score and 100 representing the best possible score. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale||Standard Deviation|Mean
2684443|NCT01368042|Primary|Change From Baseline to 6 Months Post-enrollment in RAND 36-Item Health Survey 'Physical Functioning' Scale Scores|The RAND 36-Item Health Survey questionnaire is self-completed by the participant and includes 36 questions that assess 8 different scales, including physical functioning. The scores for each scale range from 0 to 100, with 0 representing the worst possible state of physical functioning and 100 representing the best possible state of physical functioning. Baseline was 10 to 35 days prior to starting treatment with paricalcitol iv; enrollment was at least 1 month after starting treatment with paricalcitol iv. The change from baseline to the 6-month post-enrollment visit was calculated as the 6-month post-enrollment visit score minus the baseline score.|Baseline, 6 months post-enrollment|All participants in the enrolled population with an available RAND 36-Item Health Survey score at the study timepoints. Of the 265 participants enrolled, 11 were considered to have protocol deviations and were excluded from the enrolled population; therefore, 254 participants were included in the study analyses.|||scores on a scale||Standard Deviation|Mean
2684444|NCT01367886|Secondary|Overactive Bladder Questionnaire (OAB-q) Will be Used to Assess Bother From Urinary Urgency at Baseline and at 6 Weeks..|Overactive bladder subjects answered the Overactive Bladder questionnaire (OAB-q) before starting Fesoterodine and at the end of taking 6 weeks of Fesoterodine. The OAB-q consists of 8 questions asking how bothered subject was in the past 4 weeks. Questions #2 (An uncomfortable urge to urinate?); #3 (A sudden urge to urinate with little or no warning?); #4 (Accidental loss of small amounts of urine?); #7 (An uncontrollable urge to urinate?); #8 (Urine loss associated with a strong desire to urinate?) are asking about urgency. Choices for answers are: 1 (Not at all); 2 (A little bit); 3 (Somewhat); 4 (Quite a bit); 5 (A great deal); 6 (A very great deal). Multiple responses to the questionnaire was averaged per participant at baseline and at 6 weeks and then all participants answers were totaled and then averaged at baseline and at 6 weeks.|Outcome measures were assessed at baseline and after the 6 week visit.||||scores on a scale||Standard Deviation|Mean
2684445|NCT01367886|Primary|Bladder Diary (Using Urinary Sensation Scale Found in Bladder Diary) to Assess Urinary Urgency at Baseline and at 6-week Treatment|The Urinary Sensation Scale found in the bladder diary given to subjects was used to assess urinary urgency. The Urinary Sensation Scale was filled out by the subject for 3 days before starting Fesoterodine and filled out again for 3 days at the end of taking 6 weeks of Fesoterodine. The scale ranges from 1 (no feeling of urgency), 2 (mild), 3 (moderate), 4 (severe) to 5 (unable to hold; leak urine). The urgency scale with the most check marks per day over a period of 3 days before start of medication was averaged for each subject. The urgency scale with the most check marks per day over a period of 3 days at the end of taking 6 weeks of medication was averaged for each subject. Then, the average before start of medication for all subjects and the average at the end of taking 6 weeks of medication for all subjects were compared.|Outcome measure was assesses at baseline and at the end of the 6-week treatment period.||||scores on Urinary Sensation Scale||Standard Deviation|Mean
2684446|NCT01367886|Secondary|Overactive Bladder Questionnaire (OAB-q) to Assess Bother From Urinary Frequency at Baseline and at 6 Weeks.|Overactive Bladder subjects answered the Overactive Bladder Questionnaire (OAB-q) before starting Fesoterodine and at the end of taking 6 weeks of Fesoterodine. The OAB-q consists of 8 questions asking how bothered subject was in the past 4 weeks. Questions # 1 (Frequent urination during the daytime hours?); #5 (Nighttime urination?) and #6 (Waking up at night because you have to urinate?) are asking about frequency. Choices of answers are: 1 (Not at all); 2 (A little bit); 3 (Somewhat); 4 (Quite a bit); 5 (A great deal) 6 (A very great deal). Multiple responses to the questionnaire were averaged for each participant at baseline and at 6 weeks and then all participants' answers were totaled and averaged at baseline and at 6 weeks.|Outcome measure was assessed at baseline and after the 6 week visit.||||scores on a scale||Standard Deviation|Mean
2684447|NCT01367886|Primary|Bladder Diary to Assess Urinary Frequency at Baseline and at End of 6-week Treatment|Overactive bladder subjects filled out a 3-day bladder diary before starting Fesoterodine and another 3-day bladder diary at the end of taking 6 weeks of Fesoterodine. The bladder diary was used to assess urinary frequency. The average number of urinations (frequency) per day over a period of 3 days before the start of medication and at the end of 6 weeks of medication were compared for each subject and then as a group.|Outcome measure was assessed at baseline and at the end of the 6-week treatment||||urinations/day||Standard Deviation|Mean
2684448|NCT01367860|Secondary|VAS for Leg Pain - 12th Month|pain scale - VAS for leg pain - 12th month|12th month from surgery||||units on a scale||Standard Deviation|Mean
2684453|NCT01367860|Secondary|Oswestry Disability Index (ODI) - 12th Month|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.~Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.~0 is the best outcome and 50 is the worst outcome."|12th month from surgery||||units on a scale||Standard Deviation|Mean
2684454|NCT01367860|Secondary|Oswestry Disability Index (ODI) - 6th Month|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.~Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.~0 is the best outcome and 50 is the worst outcome."|6th month from surgery|Intention to treat|||units on a scale||Standard Deviation|Mean
2684455|NCT01367860|Primary|Oswestry Disability Index (ODI) - 3th Month|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.~Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.~0 is the best outcome and 50 is the worst outcome."|3th month|Intention to treat|||units on a scale||Standard Deviation|Mean
2684456|NCT01367860|Secondary|Oswestry Disability Index (ODI) - 1st Month|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.~Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.~0 is the best outcome and 50 is the worst outcome."|1st month from baseline||||units on a scale||Standard Deviation|Mean
2684457|NCT01367860|Secondary|Oswestry Disability Index (ODI) - 1st Week|"Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain.~Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5.~0 is the best outcome and 50 is the worst outcome."|1st week minus baseline|Intention to treat|||units on a scale||Standard Deviation|Mean
2684458|NCT01367860|Secondary|VAS for Lumbar Pain - 12th Month|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|12th month from surgery||||units on a scale||Standard Deviation|Mean
2684459|NCT01367860|Secondary|VAS for Lumbar Pain - 6th Month|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|6th month from surgery||||units on a scale||Standard Deviation|Mean
2684460|NCT01367860|Secondary|VAS for Lumbar Pain - 3rd Month|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|3rd month from surgery||||units on a scale||Standard Deviation|Mean
2684461|NCT01367860|Secondary|VAS for Lumbar 1st Month|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|1st month from surgery|intention to treat|||units on a scale||Standard Error|Mean
2684462|NCT01367860|Secondary|VAS for Lumbar - 1st Week|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|1st week from surgery||||units on a scale||Standard Deviation|Mean
2684463|NCT01367860|Secondary|Clinical Evaluation|"Will be measured dichotomously: (present or absent)~Variables:~Infection; residual pain; herniation recurrency"|6th month|Infection|||participants|||Number
2684464|NCT01367860|Primary|VAS for Lumbar Pain in 3 Months|Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome.|VAS for Lumbar Pain at 3 Months|intention to treat|||units on a scale||Standard Deviation|Mean
2684465|NCT01367847|Secondary|Mean Consumer Satisfaction|Average parent-reported satisfaction with the treatment program on a project-developed consumer satisfaction scale (Possible range = 11 -77; Higher score = greater satisfaction).|Post-Intervention (Average 8 to 12 weeks)|N = 15 parent-child dyads who completed the treatment program.|||score on a scale||Standard Deviation|Mean
2684466|NCT01367847|Secondary|Mean Sessions for Complete Treatment|Mean number of sessions that parent-child dyads in each group required to master the program skills and complete treatment (Fewer sessions to complete treatment considered more cost-effective as parent-child dyads learning skills more efficiently).|Baseline to Post-Intervention (Average 8 to 12 weeks)|N = 15 parent-child dyads who completed the treatment program.|||Sessions||Full Range|Mean
2684467|NCT01367847|Secondary|Mean Post-treatment Score Eyberg Child Behavior Inventory (ECBI)|The ECBI is a 36 item measure frequently used in treatment outcome research with young children, as it it reflects problem behavior in this age range and is sensitive to change. Parents rate the frequency of each problem behavior as occurring 0 = never to 7 = always. Scores can range from 0 to 252 with higher scores reflecting greater problem behaviors.|Baseline to Post-Intervention (average 8 to 12 weeks)|N = 15 parent-child dyads who completed the treatment program.|||units on a scale||Standard Deviation|Mean
2684468|NCT01367847|Primary|Mean % Sessions Attended as Scheduled|Participation in each weekly session as scheduled was recorded for each family. Mean attendance of scheduled sessions was computed for each parent-child dyad and then for each group. For example, if a parent-child dyad required 8 sessions to master the program skills and attended all 8 sessions as scheduled they would have 100%. If instead, another parent-child dyad also required 8 sessions to complete the program, but half of those were rescheduled at least once. Then the overall average attendance is calculated across the parent-child dyads in each group. Greater scheduled attendance = optimal outcome.|Baseline to Post-Intervention (average 8 to 12 weeks)|Given the pilot nature of study and smalll sample size, intent to treat analyses were not conducted. Rather, analyses were conducted on those parent-child dyads who completed all sessions within each group.|||percentage of scheduled sessions||Standard Deviation|Mean
2684470|NCT01367834|Secondary|Volume of Brain Lobes (Insular Cortex)|Percent change in volumes of parietal lobes as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).|||percentage change||Standard Deviation|Mean
2684471|NCT01367834|Secondary|Volume of Brain Lobes (Limbic)|Percent change in volumes of parietal lobes as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).|||percentage change||Standard Deviation|Mean
2684472|NCT01367834|Secondary|Volume of Brain Lobes (Parietal)|Percent change in volumes of parietal lobes as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).|||percentage change||Standard Deviation|Mean
2684473|NCT01367834|Secondary|Volume of Brain Lobes (Temporal)|Percent change in volumes of temporal lobes as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).|||percentage change||Standard Deviation|Mean
2684474|NCT01367834|Secondary|Volume of Brain Lobes (Frontal)|Percent change in volumes of frontal lobes as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).|||percentage change||Standard Deviation|Mean
2684475|NCT01367834|Secondary|Volume of Brain Lobes (Central)|Percent change in volumes of central brain region (precentral gyrus, postcentral gyrus, rolandic operculum) as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).|||percentage change||Standard Deviation|Mean
2684476|NCT01367834|Secondary|White Matter Tracts (SLF)|Change in the fractional anisotropy (FA) of white matter tracts using Diffusion Tensor Imaging (DTI); superior longitudinal fasciculus|Change in FA from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).|||percentage change||Standard Deviation|Mean
2684477|NCT01367834|Secondary|Volume of Brain Lobes (Occipital)|Percent change in volumes of occipital lobes as determined by MRI.|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).|||percentage change||Standard Deviation|Mean
2684478|NCT01367834|Primary|Total Brain Volume|Percent change in total brain volume as determined by magnetic resonance imaging (MRI)|Change in volume from 12 months of age scan in 24 months of age scan|Note that only subjects with usable MRI data are included in this analysis (this is a subset of all children completing the protocol).|||percentage change||Standard Deviation|Mean
2684479|NCT01367704|Primary|Change From Baseline to 3 Months Using the Intentions to Intervene Scale|"Proclivity to intervene when witnessing disrespectful and harmful behaviors among peers comparing baseline and follow up mean scores, using a 5-point Likert-like scale ranging from very unlikely to very likely (minimum = 1 and maximum = 5). This scale was investigator developed by Miller (PI) et al to assess participants report of how likely they would be to do something to stop the behavior and modeled as a mean of 8 items."|3 months||||mean scores||Standard Deviation|Mean
2684480|NCT01367704|Primary|Change From Baseline to 3 Months Using the Gender Equitable Attitudes Scale|"Assessment of gender-equitable attitudes comparing baseline mean score with follow up mean score, using a 5-point Likert-like scale ranging from strongly agree to strongly disagree (minimum = 1 and maximum = 5). This scale includes questions modified from Barker's Gender-Equitable Norms Scale and modeled as a mean of responses to 11 items."|3 months||||mean scores||Standard Deviation|Mean
2684481|NCT01367704|Primary|Change From Baseline to 3 Months Using the Recognition of Abusive Behavior Scale|"Recognition of disrespectful and harmful behaviors against girls as abusive comparing baseline and follow up mean scores, using a 5-point Likert-like scale ranging from not abusive to extremely abusive (minimum = 1 and maximum = 5). This scale was developed by Silverman et al to assess perceptions of the degree of abusiveness of specified relationship behaviors and modeled as a mean of responses to 12 items."|3 months||||mean scores||Standard Deviation|Mean
2684482|NCT01367665|Secondary|Percentage of Participants With a ≥ 30% Reduction in Composite Symptom Severity Score According to MDASI Scale|"M.D. Anderson Symptom Inventory (MDASI) scale. The MDASI core instrument is a 19-item patient self-report questionnaire whose items comprise two scales, symptom severity and symptom interference. For 13 items (i.e., pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness or tingling), participants were asked to rate how severe the symptoms were when at their worst in the last 24 hours. For the remaining 6 items, participants were asked to rate how much the symptoms have interfered with 6 areas of functioning (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) in the last 24 hours."|08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).|Included only participants who were enrolled after Protocol Version 4 was implemented, had non-missing data and average baseline score ≥ 4. Per protocol, the MDASI measurements were measured in Metastatic patients only.|||Percentage of participants|||Number
2684495|NCT01367457|Primary|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events (Non-SAEs).|Baseline to the 28 calendar days after the last administration of study drug (upto 80 months)|Safety population included all participants with RCC or MCL who received atleast 1 dose of study treatment.|||participants|||Number
2684483|NCT01367665|Secondary|Percentage of Participants With a ≥ 30% Reduction in Disease-Related Symptoms According to MDASI Scale|"M.D. Anderson Symptom Inventory (MDASI) scale. The MDASI core instrument is a 19-item patient self-report questionnaire whose items comprise two scales, symptom severity and symptom interference. For 13 items (i.e., pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness or tingling), participants were asked to rate how severe the symptoms were when at their worst in the last 24 hours. For the remaining 6 items, participants were asked to rate how much the symptoms have interfered with 6 areas of functioning (i.e., general activity, walking, work, mood, relations with other people, and enjoyment of life) in the last 24 hours."|08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month).|Included only participants who were enrolled after Protocol Version 4 was implemented, had non-missing data and baseline score ≥4. Per protocol, the MDASI measurements were measured in Metastatic patients only.|||Percentage of participants|||Number
2684484|NCT01367665|Secondary|Change From Baseline Scores of Skindex-16 Questionnaire Domains of Emotion, Function and Symptom|The Skindex-16 questionnaire includes three domains for the assessment of the effects of skin disease on participants' quality of life: symptoms, emotions and function. For each domain, responses from the questionnaire were transformed to a linear scale of 100 varying from 0 (never bothered, i.e., best) to 100 (always bothers, i.e., worst).|Baseline to the data cut-off date of 14 June 2017 (up to 6 years).|Only included participants that had histologically confirmed disease at baseline. For each time point, Number Analyzed refers to patients with non-missing values.|||units on a scale||Standard Deviation|Mean
2684485|NCT01367665|Secondary|Overall Survival (OS)|OS was defined as the time from the date of first treatment to the date of death, regardless of the cause of death.|Baseline to the data cut-off of 14 June 2017 (up to 6 years)|Only included participants that had histologically confirmed disease and measureable disease status at baseline (measureable or non-measureable).|||months||95% Confidence Interval|Median
2684486|NCT01367665|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time interval between the date of the first therapy and the date of progression or death for any causes, whichever occurs first. Disease progression was assessed by the investigator.|Baseline to the data cut-off of 14 June 2017 (up to 6 years)|Only included participants that had histologically confirmed disease and measureable disease status at baseline (measureable or non-measureable).|||months||95% Confidence Interval|Median
2684487|NCT01367665|Secondary|Time to Response|Time to response was defined as the interval between the date of first treatment and the date of first documentation of confirmed CR or PR (whichever occur first).|Baseline to the data cut-off of 14 June 2017 (up to 6 years)|Only included participants that had histologically confirmed measurable disease at baseline.|||months||95% Confidence Interval|Median
2684488|NCT01367665|Secondary|Duration of Response|Duration of response was defined as the time interval between the date of the earliest qualifying response (CR or PR) and the date of disease progression or death for any cause. Median duration of response was estimated using Kaplan-Meier estimates.|Baseline to the data cut-off of 14 June 2017 (up to 6 years)|Only included participants that had histologically confirmed disease, measureable disease status at baseline (measureable or non-measureable) and reported a response of CR or PR.|||months||95% Confidence Interval|Median
2684489|NCT01367665|Secondary|Best Overall Response Rate (BORR)|BORR was defined as the percentage of participants achieving either a complete response (CR) or a partial response (PR) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) required a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.|Baseline to the data cut-off of 14 June 2017 (up to 6 years)|Only included participants that had histologically confirmed measurable disease at baseline.|||percentage of participants|||Number
2684490|NCT01367665|Primary|Exposure to Study Treatment - Dose Intensity|Dose intensity was defined as the percentage of actual number of doses received versus planned.|Baseline to the data cut-off of 14 June 2017 (up to 6 years)||||percentage of doses||Full Range|Median
2684491|NCT01367665|Primary|Exposure to Study Treatment: Duration on Treatment|Duration on treatment was the number of days between first and last dose of study treatment.|Baseline to the data cut-off of 14 June 2017 (up to 6 years)||||days||Full Range|Median
2684492|NCT01367665|Primary|Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters||Baseline to the data cut-off of 14 June 2017 (up to 6 years)||||percentage of participants|||Number
2684493|NCT01367665|Primary|Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons|"Reasons for other included unknown, natural causes, cardiac decompensation, general state alteration, deterioration of general state, clinical deterioration taking into consideration patient's age, old age, and disease progression of mediastinal squamous cell carcinoma (SCC)."|Baseline to the data cut-off of 14 June 2017 (up to 6 years)||||percentage of participants|||Number
2684494|NCT01367665|Primary|Percentage of Participants Who Experienced Any Adverse Events (AEs), AEs Grade 3 or 4, AEs Leading to Drug Interruptions or Discontinuations and Any Serious Adverse Events (SAEs)|Adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activity of daily living with inability to perform bathing, dressing and undressing, feeding self, using the toilet, taking medications but not bedridden. Grade 4: An immediate threat to life. Urgent medical intervention is required in order to maintain survival.|Baseline to the data cut-off of 14 June 2017 (up to 6 years)||||percentage of participants|||Number
2684496|NCT01367457|Primary|Overall Survival (OS)|Overall survival (OS) was defined as the interval from the day of the start of the treatment to death, or censored to the last date when the participant was identified to be alive.|From initiation of treatment untill death (up to 80 months)|Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment.|||months||95% Confidence Interval|Median
2687711|NCT01339897|Secondary|Pharmacokinetics of N6022|N6022 AUC0-tau measurements from Day 1|Day 1, 24 hours|Any subject that completed N6022 or placebo PK sampling|||h*ng/mL||Geometric Coefficient of Variation|Geometric Mean
2684497|NCT01367457|Primary|Duration of Response (DOR)|Duration of response (DOR) was defined as the interval from the date the response was documented to the first date that progression of disease (PD) was observed in participants with PR or CR. RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. PD, CR and PR are defined in primary outcome 1 and 2.|From initiation of treatment up to disease progression (up to 80 months)|Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.|||months||95% Confidence Interval|Median
2684498|NCT01367457|Primary|Percentage of Participants With Objective Response|Objective response: percentage of participants who achieved complete remission (CR) or partial response (PR). RECIST criteria was used for participants with RCC and Cheson criteria for participants with MCL. RECIST criteria (CR: disappearance of all target lesions, any pathological lymph nodes(target or non-target) reduced in short axis to <10 mm, PR: at least 30% decrease in sum of diameters of target lesions). Cheson criteria (CR: all lymph node masses regressed to normal size, each lymph node mass that was >1.5 cm in longest transverse dimension regressed to <=1.5 cm, lymph node mass that was 1.1-1.5 cm regressed to <=1 cm, complete disappearance of all radiographic evidence of disease, PR: at least 50% decrease in sum of products of the longest perpendicular dimensions of the previously identified dominant lymph node masses, no increase in size of other lymph nodes.)|From initiation of treatment up to disease progression (up to 80 months)|Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment.|||percentage of participants|||Number
2684499|NCT01367457|Primary|Progression-free Survival (PFS)|Progression-free survival: interval between start of treatment to first day when progressive disease (PD) was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) for participants with RCC and Cheson criteria for participants with MCL, or death due to any cause. RECIST criteria: at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). Appearance of one or more new lesions also considered progression. Cheson criteria: appearance of any new sites of lymphoma OR at least 50% increase in product of longest perpendicular dimensions of any previously identified lymph node mass (LNM) OR at least 50% increase in longest dimension of any previously identified LNM greater than 1 cm in longest transverse dimension OR at least 50% increase in size of any previously involved site of lymphoma.|From initiation of treatment up to disease progression (up to 80 months)|Evaluable population included all participants with RCC or MCL who received atleast 1 dose of study treatment.|||months||95% Confidence Interval|Median
2684500|NCT01367262|Secondary|Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Feces|The metabolites of LY2886721 were identified using an HPLC chromatogram. The relative abundance of LY2886721 and its metabolites in feces were reported as a percentage of recovered radioactivity and calculated by dividing the sum of the radioactive content of fractions contributing to a particular peak by the sum of the radioactive content of all fractions in the radio chromatogram, then multiplying by 100. Radioactivity corresponds to 80 μCi [^14C]-LY2886721.|0 to 144 hours postdose|All enrolled participants.|||percentage of recovered radioactivity||Standard Deviation|Mean
2684501|NCT01367262|Secondary|Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Urine|The metabolites of LY2886721 were identified using an HPLC chromatogram. The relative abundance of LY2886721 and its metabolites in urine were reported as a percentage of recovered radioactivity and calculated by dividing the sum of the radioactive content of fractions contributing to a particular peak by the sum of the radioactive content of all fractions in the radio chromatogram, then multiplying by 100. Radioactivity corresponds to 80 μCi [^14C]-LY2886721.|0 to 72 hours postdose|All enrolled participants.|||percentage of recovered radioactivity||Standard Deviation|Mean
2684502|NCT01367262|Secondary|Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Plasma|The metabolites of LY2886721 were identified using a high performance liquid chromatography (HPLC) chromatogram. The relative abundance of LY2886721 and its metabolites in plasma were reported as a percentage of recovered radioactivity and calculated by dividing the sum of the radioactive content of fractions contributing to a particular peak by the sum of the radioactive content of all fractions in the radio chromatogram, then multiplying by 100. Radioactivity corresponds to 80 μCi [^14C]-LY2886721.|1 to 8 hours postdose|All enrolled participants.|||percentage of recovered radioactivity||Standard Deviation|Mean
2684503|NCT01367262|Secondary|PK of Radioactivity: Cmax|The Cmax of total radioactivity in plasma and whole blood are reported as nanogram equivalents per milliliter (ng Eq/mL).|Predose up to 4 days (96 hours) postdose|All enrolled participants.|||ng Eq/mL||Geometric Coefficient of Variation|Geometric Mean
2684504|NCT01367262|Secondary|Plasma PK of LY2886721: Maximum Observed Concentration (Cmax)||Predose up to 4 days (96 hours) postdose|All enrolled participants.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2684505|NCT01367262|Secondary|PK of Radioactivity: AUC(0 to Inf)|AUC(0 to inf) for plasma and whole blood total radioactivity is reported as hours*nanogram equivalents per milliliter (h*ng Eq/mL).|Predose up to 4 days (96 hours) postdose|All enrolled participants.|||h*ng Eq/mL||Geometric Coefficient of Variation|Geometric Mean
2684506|NCT01367262|Secondary|Plasma Pharmacokinetics (PK) of LY2886721: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0 to Inf)]||Predose up to 4 days (96 hours) postdose|All enrolled participants.|||hours*nanograms per milliliter (h*ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2684507|NCT01367262|Primary|Percentage of Urinary and Fecal Excretion of LY2886721 Radioactivity Over Time|Urinary and fecal excretion of LY2886721 radioactivity over time was expressed as a percentage of the total radioactive dose administered. The amount of drug-related material excreted in urine and feces (Ae) at a specific collection interval (i) was calculated as the product of radioactivity concentration and volume or weight. The Ae values for each collection interval were then summed and calculated as Total Ae=Ae(i1)+Ae(i2)+Ae(in). The percentage of the total radiolabeled dose administered that was excreted in feces or urine=[(Total Ae)/(Total radioactive dose administered)]*100.|Predose up to 7 days (168 hours) postdose|All enrolled participants.|||percentage of radioactive dose||Standard Deviation|Mean
2684508|NCT01367249|Secondary|Ocular Pain|"The proportion of subjects who were free of ocular pain at Day 1. Pain Free defined as a score of None on the pain scale of the Ocular Comfort Grading Assessment in the subject diary."|Day 1|LOCF Analysis, ITT Population|||eyes|Participants||Number
2684510|NCT01367236|Secondary|Brain Function, Absolute Change Over 48 Weeks of N-acetyl Aspartate/Creatinine Ratio|The study team will assess the brain functions at each visit. The results of the MRI scans will be compared, changes in N-acetyl aspartate/creatinine ratio over 48 weeks.|48 weeks||||ratio of N-acetyl aspartate/creatin||Standard Deviation|Mean
2684511|NCT01367236|Primary|Cognitive Function, Global Cognitive Score (Z-score)|"When commencing antiretroviral therapy (anti-HIV therapy) for the first time, improvements in the function of the brain are frequently observed. For example memory and concentration may improve. However, whether these improvements may differ between different anti-HIV therapies is largely unknown.~The purpose of this study is to compare two different combination anti-HIV therapies over 48 weeks and to assess if differences in improvement in the function of the brain are observed over this period.~Score increase means improved performance of cognitive function"|24 weeks, 48 weeks||||z score||Standard Error|Mean
2684512|NCT01367158|Secondary|Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) After Vaccination|Solicited local and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.|From Day 1 to Day 7 after vaccination|Analysis was done on Safety Set (all subjects in the exposed set who provided post-vaccination solicited AE data).|||Number of Subjects|||Number
2684513|NCT01367158|Secondary|Numbers of Subjects With Other Unsolicited AEs|Unsolicited AEs were collected from Day 8 After vaccination Through Study Termination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.|Day 8 After vaccination Through Study Termination, up to 6 months|Analysis was done on the Safety Set (all subjects in the exposed set who provided post-vaccination unsolicited AE data).|||Number of Subjects|||Number
2684514|NCT01367158|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination|Unsolicited AEs were collected with onset from Day 1 through Day 7 After Vaccination. One subject initially randomized to group 3ABCWYqOMV and supposed to receive rMenB+1/4OMV+ACWY as the third vaccination, actually received Tdap as the third vaccination and was included in 2ABCWYqOMV group for the safety analysis.|From Day 1 to Day 7 after vaccination|Analysis was done on the Safety Set (all subjects in the exposed set who provided post-vaccination unsolicited AE data).|||Number of Subjects|||Number
2684515|NCT01367158|Secondary|GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.|||Ratio||95% Confidence Interval|Geometric Mean
2684516|NCT01367158|Secondary|GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.|||Titers||95% Confidence Interval|Geometric Mean
2684517|NCT01367158|Secondary|GMR Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.|||Ratio||95% Confidence Interval|Geometric Mean
2684518|NCT01367158|Secondary|GMT Against Serogroups A, C, W, and Y at Month 0 Through Month 12 Following Vaccination at 0, 2 and 6 Months With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.|||Titers||95% Confidence Interval|Geometric Mean
2684519|NCT01367158|Secondary|GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (month 6) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.|||Ratio||95% Confidence Interval|Geometric Mean
2684520|NCT01367158|Secondary|GMT Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0 and Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, After Third Vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.|||Titers||95% Confidence Interval|Geometric Mean
2684757|NCT01364584|Secondary|Change in (Non-invasively Measured) Deoxygenated Hemoglobin Concentration in the Vastus Lateralis During Exercise|Deoxygenated hemoglobin concentration will be measured using near-infrared spectroscopy during sub-maximal exercise before and after 3 months of study drug administration.|Baseline and 3 months|Data not collected||||||
2684521|NCT01367158|Secondary|GMR for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratios (95%CI) Against N meningitidis Serogroups A, C, W and Y after after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|At month 1, 3, 6, 7 and 12|Analysis was done by Per MITT Set.|||Ratio||95% Confidence Interval|Geometric Mean
2684522|NCT01367158|Secondary|GMT for N Meningitidis Serogroups A, C, W and Y at Month 0 Through Month 12 Following Vaccination at Month 0, Month 2 With One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against N meningitidis Serogroups A, C, W and Y after first (month 1) and second (month 3) vaccination during the parent study NCT01210885, after 6 month of the first vaccination (6 month) in the parent study and after the third vaccination (month 7) and 6 month after the third vaccination (month 12) with One of Four MenABCWY Formulations, rMenB, or MenACWY/Placebo.|At month 1, 3, 6, 7 and 12|Analysis was done by MITT Set.|||Titers||95% Confidence Interval|Geometric Mean
2684523|NCT01367158|Secondary|Percentages of Subjects With 4-fold Increase in hSBA Titers Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as the percentage of subjects with 4-fold Increase in human serum bactericidal assay (hSBA) titers and associated 95% CI, Against Serogroup B Test Strains at One Month After Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|At month 7|Analysis was done by MITT month 7 Set.|||Percentages of subjects||95% Confidence Interval|Number
2684524|NCT01367158|Secondary|Percentages of Subjects With Seroresponse Against N Meningitidis Serogroups A, C, W and Y at 1 Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as the percentage of subjects with seroresponse Against N meningitidis Serogroups A, C, W and Y, after pre and post vaccination at month 6 and after the third vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo. Seroresponse to N meningitidis serogroups A, C, W and Y is defined as: For subjects with a prevaccination hSBA <1:4, a postvaccination hSBA ≥1:8;For subjects with a prevaccination hSBA ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.|At month 7|Analysis was done by MITT month 7 Set.|||Percentages of subjects||95% Confidence Interval|Number
2684525|NCT01367158|Secondary|GMR for (95%CI) for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratio (95% CI), against Serogroup B Test Strains at One Month After the Third Vaccination (month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|At month 7|Analysis was done by MITT Month 7 Set.|||Ratio||95% Confidence Interval|Geometric Mean
2684526|NCT01367158|Secondary|GMT for N Meningitidis Against Serogroup B Test Strains at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7) with One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|At month 6 and month 7|Analysis was done by MITT Month 7 Set.|||Titers||95% Confidence Interval|Geometric Mean
2684527|NCT01367158|Secondary|Geometric Mean Ratio (GMR) for (95%CI) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as Geometric Mean Ratio (95% CI), against N meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination (month 7) With One of Four MenABCWY Formulations or rMenB|At month 7|Analysis was done by MITT Month 7 Set.|||Ratio||95% Confidence Interval|Geometric Mean
2684528|NCT01367158|Secondary|Geometric Mean Titers (GMT) for N Meningitidis Serogroups A, C, W and Y at One Month After the Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as Geometric Mean hSBA Titers against N meningitidis Serogroups A, C, W and Y at One of Four MenABCWY Formulations or rMenB at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)|At month 6 and month 7|Analysis was done by MITT Month 7 Set.|||Titers||95% Confidence Interval|Geometric Mean
2684529|NCT01367158|Primary|Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains at One Month After Third Vaccination With One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:5 and associated 95% CI, directed against to Serogroup B Test Strains at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7)|At month 6 and month 7|Analysis was done by MITT Month 7 Set.|||Percentages of subjects||95% Confidence Interval|Number
2684530|NCT01367158|Primary|Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo|Antibody response was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥1:8 and associated 95% CI, directed against to N meningitidis serogroups A, C, W, and Y at 6 months following first vaccine during the parent study NCT01210885 and one month after third vaccination (Month 7).|At month 6 and month 7|Analysis was done by Modified Intention-To-Treat (MITT) Month 7 Set. MITT is defined as all subjects in the enrolled set who received a study vaccination at Month 6 and provided one evaluable serum sample at Month 7.|||Percentages of subjects||95% Confidence Interval|Number
2684531|NCT01367119|Secondary|Mean Post Anesthesia Recovery Side Effects|Post anesthesia recovery side effects were assessed at the time of discharge from recovery with five patient self-report items: nausea, headache, myalgia, visual disturbance, and confusion. These were rated by the patients on a four point scale (0, 1, 2, 3) - absent, mild, moderate, severe. This means that for each item a subject could score between 0 (no symptoms) and 3 (severe symptoms). Also, degree of recovery room agitation was rated by the nurse on a similar four point scale.|Time of discharge from recovery after ECT for each treatment, approximately 30 minutes after the end of the seizure||||units on a scale||Standard Deviation|Mean
2700347|NCT01243320|Primary|Change In White Blood Count Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||k/uL||95% Confidence Interval|Mean
2684532|NCT01367119|Secondary|Mean Depression Rating Using the Patient Health Questionnaire-9 (PHQ-9)|"The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV). Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 27 (severe symptoms) for depression.~The questionnaire was administered to the subjects prior to the first treatment, the morning of the third treatment, the morning of the fifth treatment, and the morning of the seventh treatment. For subjects whos treatment series ws cancelled prior to a scheduled next administration of the rating scale, every effort was mde to administer them 2 days after the last treatment.~Means are reported overall across all treatments; p-values also take into account variability across treatments and within subject."|Baseline and after every second treatment for 7 treatments|Analysis was intent to treat; for the ketamine arm there were 65 observations, for the methohexital arm there were 63 observations.|||units on a scale||Standard Deviation|Mean
2684533|NCT01367119|Primary|Mean Depression Rating Using the Hospital Anxiety and Depression Scale (HADS)|"The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 42 (severe symptoms) for either anxiety or depression.~The questionnaire was administered to the subjects prior to the first treatment, the morning of the third treatment, the morning of the fifth treatment, and the morning of the seventh treatment. For subjects whose treatment series ws cancelled prior to a scheduled next administration of the rating scale, every effort was made to administer them 2 days after the last treatment.~Means are reported overall across all treatments; p-values also take into account variability across treatments and within subject."|Baseline and after every second treatment for 7 treatments|Analysis was intent to treat; for the ketamine arm there were 54 observations, for the methohexital arm there were 55 observations.|||units on a scale||Standard Deviation|Mean
2684534|NCT01367080|Secondary|t1/2|Terminal half-time(t1/2) of Amitryptyline in Plasma|Up to 72 hours||||hour||Standard Deviation|Mean
2684535|NCT01367080|Secondary|Tmax|Time for Maximum Concentration(Tmax) of Amitryptyline in Plasma|Up to 72 hours||||hour||Standard Deviation|Mean
2684536|NCT01367080|Secondary|Cmax|Maximum Concentration(Cmax) of amitryptyline in plasma|Up to 72 hours||||ng/mL||Standard Deviation|Mean
2684537|NCT01367080|Primary|AUClast and AUCinf|Area Under the Plasma concentration-time curve from time Zero to Infinity(AUCinf) and Area Under the Plasma concentration-time curve from time Zero to last time(AUClast) of Amitryptiline in plasma|Up to 72 hours||||ng*hr/mL||Standard Deviation|Mean
2684538|NCT01366976|Secondary|Serum Creatinine|Serum creatinine measured over a 72 hour period|72 hours||||mg/dL||Standard Error|Mean
2684539|NCT01366976|Primary|Plasma F2-isoprostane Concentrations|Plasma F2-isoprostane concentrations as a measure of lipid peroxidation|24 hours||||pg/mL||Standard Error|Mean
2684540|NCT01366976|Secondary|Urinary NGAL (Neutrophil Gelatinase-associated Lipocalin)|Changes in urinary NGAL (neutrophil gelatinase-associated lipocalin) as marker of acute kidney injury|24 hours||||ng/mL||Standard Error|Mean
2684541|NCT01366976|Primary|Plasma Isofuran Concentrations|Plasma isofuran concentrations as a measure of lipid peroxidation|24 hours||||pg/mL||Standard Error|Mean
2684542|NCT01366885|Secondary|Number of Mothers Who Developed Side Effects From Vitamin D|Mother will be followed by blood and urine screening for hypercalcemia and hypercalciuria which is the primary side effects of too much vitamin D.|During pregnancy and the 3 years of the child's development|The children born were assessed for whether they developed autism or not.|||participants|||Number
2684543|NCT01366885|Primary|Number of Children Who Developed Autism|The child will be screened by an Modified Checklist for Autism in Toddlers (MCHAT) interview at 18 months of age, and by a questionnaire, the Pervasive Developmental Disorder Behavioral Inventory (PDDBI) at 3 years of age to determine whether the child has developed autism or not.|Child assessed at 3 years of age|Children who developed autism|||Children who developed autism|||Number
2684544|NCT01366872|Secondary|Radiographic Predictors of Implant Failures and Poor Outcomes|Post-Operative radiographic disposition. Subsidence is described as the component sinking into the bone. Ingrowth is described as the implant components to conform into the tibia and talus.|A Minimum of 2 Years Post Index Procedure|Per protocol, patients who were completely revised were excluded.|||participants|||Number
2684545|NCT01366872|Secondary|Evaluation of Complication and Reoperation Rates|Number of reported complications/reoperations following the index procedure.|A Minimum of 2 Years Post Index Procedure|Per Protocol|||participants|||Number
2684546|NCT01366872|Primary|Assessment of Functional Outcomes Following Agility LP Ankle Replacement|Range of Motion - Combined total of dorsiflexion and plantarflexion. Full range of motion is described as 30 degrees or more. Partial limitation is described as 29 to 15 degrees. Range of motion that is less than 15 degrees is described as severely limited.|A Minimum of 2 Years Post Index Procedure|Per surgical history (protocol).|||Degrees||Standard Deviation|Mean
2684547|NCT01366846|Secondary|Number of Peanut Avoidance After Peanut Consumption Group Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within in the Per Protocol Population|At 60 and 72 months of age, eligible participants were given an oral food challenge (intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 9.4g/13.7g (month 60/month 72) of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|60 months and 72 months|Per Protocol|||Participants|||Count of Participants
2684645|NCT01365611|Primary|MRT (the Mean Residence Time of Ketorolac Tromethamine, Where Possible)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6|The half-life could not be estimated for a subject due to the nature of the subject's PK profile.|||hours||Standard Deviation|Mean
2684548|NCT01366846|Secondary|Number of Participants With Peanut Allergy (PA) at 60- and 72-month Visits Within the Peanut Avoidance After Peanut Consumption Group|At 60 and 72 months of age, eligible participants were given an oral food challenge (intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 9.4g/13.7g (month 60/month 72) of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|60 months and 72 months|Intent-to-treat|||Participants|||Count of Participants
2684549|NCT01366846|Primary|Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group in the Per Protocol Population|At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|72 months|Per Protocol|||Participants|||Count of Participants
2684550|NCT01366846|Primary|Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum in the Per Protocol Population|At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have peanut allergy.|72 months|Per Protocol|||Participants|||Count of Participants
2684551|NCT01366846|Primary|Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Treatment Group|At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose). Participants were considered to have no peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|72 months|Intent-to-treat with available data at 72 Months|||Participants|||Count of Participants
2684552|NCT01366846|Primary|Number of Participants With Peanut Allergy (PA) at 72 Months of Age - by Skin Prick Test Stratum|At 72 months of age, eligible participants were given an oral food challenge (oral intake of 5g of peanut protein in a single dose). Participants were considered to not have peanut allergy (PA) if they experienced no reaction following the food challenge. Those who did react were offered a double-blind, placebo-controlled food challenge with a total of 13.7g of peanut protein administered in increments. These participants were considered to have PA if they experienced a reaction at any point during the dose escalation. For participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on the results of a SPT and the values for peanut-specific IgE were used to determine whether or not a participant should be considered to have PA.|72 months|Intent-to-treat with available data at 72 months|||Participants|||Count of Participants
2684553|NCT01366638|Primary|Plasma Concentrations of TMC435|"The table below shows the median (range) TMC435 predose plasma concentrations (C0h) and maximum concentration (Cmax) values for participants in each treatment group. Overall is the median exposure estimate using all available data for each participant in the study. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Overall (Up to Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population, defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.|||ng/mL||Full Range|Median
2684554|NCT01366638|Primary|The Area Under the Plasma Concentration-Time Curve (From 0 to 24 Hours) (AUC24h)|"The table below shows the median (range) AUC24h values for TMC435 for all participants in each TMC435 treatment group who received TMC435 for up to 12 weeks. Overall is the median exposure estimate using all available data for each participant in the study. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Overall (Up to Week 12)|Pharmacokinetic (PK) analysis was performed in the PK population, defined as all participants from whom sparse blood samples were drawn and who received at least 1 dose of study medication.|||ng·h/mL||Full Range|Median
2684562|NCT01366638|Primary|The Percentage of Participants With a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)|"The table below shows the percentage of participants in each treatment group with an SVR12 defined as participants with undetectable plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment (Week 24 or 48) who also had undetectable plasma HCV RNA 12 weeks after the last dose of treatment (Week 36 or 60). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 36 or 60|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of Participants|||Number
2688164|NCT01335932|Secondary|Incidence of CMV Reactivation >1,000 IU Per mL at 28 Days in Throat|Number of participants with CMV reactivation >1,000 IU per mL at day 28 in throat|at 28 days post-randomization||||Participants|||Count of Participants
2684555|NCT01366638|Primary|The Percentage of Participants Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2b (PegIFNα-2b) and Ribavirin (RBV) at Week 24|"The table below shows the percentage of participants in each treatment group who met RGT criteria (ie, who had plasma levels of hepatitis C virus ribonucleic acid [HCV RNA] <1.2 log10 IU/mL detectable/undetectable at Week 4 and <1.2 log 10 IU/mL undetectable at Week 12) and completed treatment with PegIFNα-2b and RBV at Week 24. Participants in the TMC435 Treatment-Naïve and TMC435 Prior Relapser treatment groups not meeting RGT criteria continued treatment with PegIFNα-2a and RBV to Week 48 (does not apply to the TMC435 Non-responder treatment group because the specified treatment duration was 48 weeks and RGT criteria was not assessed at Week 24). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Week 24 or 48|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2684556|NCT01366638|Primary|The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up|"The table below shows the percentage of participants in each treatment group with greater than or equal to 2 log10 IU/mL drop from baseline in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at each time point during treatment and post-treatment follow-up. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Day 3, Day 7 and Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, EOT (up to Week 24 or 48), follow-up (FU) Week 4, 12, and 24|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2684557|NCT01366638|Primary|The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal Limit of ALT at the End of Treatment (EOT)|"The table below shows the number of participants in each treatment group with abnormal ALT levels at Baseline who achieved normalization of ALT levels defined as having an ALT value less than or equal to the Upper Limit of Normality (ie, 40 IU/mL) at EOT. At Baseline, 15 treatment-naïve participants, 13 prior relapsers, and 13 prior non-responders had abnormal ALT levels at Baseline. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Up to Week 48|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2684558|NCT01366638|Primary|The Number of Participants Demonstrating Viral Relapse|"The table below shows the number of participants in each treatment group who demonstrated viral relapse, defined as having undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels at end of treatment (EOT [Week 24 or 48]) and detectable HCV RNA during follow-up or detectable HCV RNA at the time points of an assessment of sustained virologic response (SVR). The number of participants analyzed in each treatment group below are those with undetectable HCV RNA levels at EOT and with at least one follow-up HCV RNA measurement. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Up to 72 weeks|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
2684559|NCT01366638|Primary|The Number of Participants With Viral Breakthrough|"The table below shows the number of participants in each treatment group who experienced viral breakthrough during the TMC435 treatment period. Viral breakthrough is defined as a confirmed increase of greater than 1 log10 IU/mL in plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached or a confirmed value of plasma HCV RNA of greater than 2.0 log10 IU/mL in participants whose plasma HCV RNA level had previously been reported below 1.2 log10 IU/mL detectable or undetectable. NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Up to 48 Weeks|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Participants|||Number
2684560|NCT01366638|Primary|The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During Treatment and at the End of Treatment|"The table below shows the percentage of participants in each treatment group with undetectable HCV RNA less than 1.2 log10 IU/mL during treatment and at end of treatment (EOT). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|Weeks 4, 12, 24, 36, 48, 60, 72, and EOT (up to Week 48)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2684561|NCT01366638|Primary|The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)|"The table below shows the percentage of participants in each treatment group with a SVR24 defined as participants with undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) at the end of treatment and at 24 weeks after the last dose of treatment (Week 48 or 72). NOTE: All outcome measures reported in this study are Exploratory; not Primary as indicated (refer to Limits and Caveats)."|24 weeks after the last dose of treatment (Week 48 or 72)|The Full Analysis Set (FAS) consisted of all participants who received at least one dose of study drug during the study except for those who did not meet the major eligibility criteria for the study and participants who did not have efficacy data available after treatment with study medication.|||Percentage of participants|||Number
2684716|NCT01365052|Primary|Percentage of Subjects With Any Serious Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product|Please see further details in AE section|10 days after randomization|Safety population|||Percentage of participants|||Number
2684563|NCT01366534|Secondary|Frequency of CS-specific T-cells Producing IFN-γ|The analysis was performed via Enzyme-Linked Immunospot (ELISPOT) N-terminal assay. Data are presented as the number of spots per million peripheral blood mononuclear cells (PBMCs).|14 days post-dose 1 (Day 14)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.|||spots/million PBMCs||Standard Deviation|Mean
2684564|NCT01366534|Secondary|Frequency of CS-specific T-cells Producing IFN-γ|The analysis was performed via Enzyme-Linked Immunospot (ELISPOT) full length assay. Data are presented as the number of spots per million peripheral blood mononuclear cells (PBMCs). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.|14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.|||spots/million PBMCs||Standard Deviation|Mean
2684565|NCT01366534|Secondary|Frequency of HBs-specific CD4+ T-cells|HB-specific CD4+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMCs). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.|14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.|||T-cells/million PBMCs||Standard Deviation|Mean
2684566|NCT01366534|Secondary|Frequency of CS (Total CS or Repeat)-Specific CD8+ T Cells|CS-specific CD8+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMC). Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.|14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.|||T-cells/million PBMCs||Standard Deviation|Mean
2684567|NCT01366534|Secondary|Frequency of CS (Total CS or Repeat)-Specific CD4+ T-cells|CS-specific CD4+ T-cells expressing at least 2 cytokines/activation markers between IL-2, IFN-γ, TNF-α and CD40-L are presented here. Analysis was performed via intra-cellular staining (ICS) assays, data are presented as frequency of T-cells per million peripheral blood mononuclear cells (PBMCs).Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore the frequency for this group is presented as from Day 77.|14 days post-dose 1 (Day 14), 14 days post-dose 2 (Day 42), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.|||T-cells/million PBMCs||Standard Deviation|Mean
2684568|NCT01366534|Secondary|Anti-Adenovirus Type 35 (Ad35) Neutralizing Antibody Titers at Specified Time Points|Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77.|28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
2684569|NCT01366534|Secondary|Anti-hepatitis B (Anti-HBs) Antibody Titers|Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77.|28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
2684615|NCT01365910|Secondary|Overall Survival|Estimated probable duration of life from on‐study date to date of death from any cause, using the Kaplan‐Meier method with censoring.|Every 3 months, up to 2 years|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.|||days||95% Confidence Interval|Median
2700348|NCT01243320|Primary|Change In Calcium Blood Level|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mg/dL||95% Confidence Interval|Mean
2684570|NCT01366534|Secondary|Anti-circumsporozoite Protein (Anti-CS) Antibody Titers|Titers are presented as geometric mean titers (GMTs) and are measured in titers. Volunteers from Control Group did not receive any immunization, but were subjected to the sporozoite challenge, therefore GMTs for this group are presented as from Day 77.|28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)|The analyses were performed on the According-to-Protocol (ATP) cohort for Immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements, who did not report any underlying medical condition influencing immune responses and for whom immunogenicity data were available.|||Titers||95% Confidence Interval|Geometric Mean
2684571|NCT01366534|Secondary|Number of Days Until the Onset of P. Falciparum Parasitemia Following Sporozoite Challenge|The onset of P. falciparum parasitemia was defined by a positive blood slide.|From day of challenge (Day 0) up to 159 days post-challenge|The analyses were performed on the According-to-Protocol (ATP) cohort for Efficacy, which included all evaluable subjects who did not use any medication or blood products forbidden by the protocol, who did not report any under lying medical condition influencing immune responses, for whom efficacy data were available.|||Days||Standard Deviation|Mean
2684572|NCT01366534|Primary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|Throughout the study period (Day 0 - Day 236)|The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented. All challenged infectivity controls were also included in this cohort and presented as a separate group.|||Participants|||Count of Participants
2684573|NCT01366534|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 30-day (Day 0 - Day 29) follow-up period post-challenge|The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented. All challenged infectivity controls were also included in this cohort and presented as a separate group.|||Participants|||Count of Participants
2684574|NCT01366534|Primary|Number of Subjects With Any Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within the 30-day (Day 0 - Day 29) follow-up period post-vaccination|The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented.|||Participants|||Count of Participants
2684575|NCT01366534|Primary|Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms|Assessed solicited general symptoms were chills, fatigue, gastrointestinal symptoms, headache and temperature [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.Grade 3 Chills = rigors [uncontrollable shivering more than (>) 15 seconds]. Grade 3 Fatigue, Gastrointestinal symptoms and Headache = symptoms that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within the 7-day (Day 0 - Day 6) follow-up period post-vaccination|The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented, who had their symptoms sheet filled in.|||Participants|||Count of Participants
2684576|NCT01366534|Primary|Number of Subjects With Any and Grade 3 Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.|Within the 7-day (Day 0 - Day 6) follow-up period post-vaccination|The analyses were performed on the Intention-to-treat (ITT) cohort, which included all subjects with at least one vaccine administration documented, who had their symptoms sheet filled in.|||Participants|||Count of Participants
2684577|NCT01366534|Primary|Number of Subjects With Plasmodium Falciparum Parasitemia Following Sporozoite Challenge|P. falciparum parasitemia was defined as a positive blood slide.|28 days following sporozoite challenge (Day 105)|The analyses were performed on the According-to-Protocol (ATP) cohort for Efficacy, which included all evaluable subjects who did not use any medication or blood products forbidden by the protocol, who did not report any under lying medical condition influencing immune responses, for whom efficacy data were available.|||Participants|||Count of Participants
2684578|NCT01366521|Secondary|Mean Dose Normalized Cmax Ratio to Assess the Relative Bioavailability of SC Mepolizumab as Compared With IV Mepolizumab|Maximum plasma concentration was estimated by population modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Log-transformed dose-normalized (DM) Cmax were be analyzed using an analysis of variance (ANOVA) model. The ratio for each SC dose group versus IV and across SC doses versus IV will be estimated from the model together with associated 90% confidence intervals. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).|||Percentage||90% Confidence Interval|Mean
2684717|NCT01365052|Primary|Percentage of Subjects With Any Adverse Event for Those Subjects Who Were Randomized and Took at Least One Dose of Investigational Product|Please see further details in Adverse Events (AE) section|10 days after randomization|Safety population|||Percentage of participants|||Number
2684579|NCT01366521|Secondary|Mean AUC to Assess the Absolute Bioavailability of SC Mepolizumab|Population modelling techniques using non-linear mixed effect methods were used to estimate individual and population pharmacokinetic parameters from the sparse sampling. Log-transformed individual clearance estimates were analysed using an analysis of variance (ANOVA) model. The absolute bioavailability for each SC dose group and across SC doses will be estimated from the model together with associated 90% confidence intervals. Blood samples for PK analyses were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population|||Percentage||90% Confidence Interval|Mean
2684580|NCT01366521|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 3|The number of participants with normal, abnormal - clinically significant (CS), and abnormal - not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), at Screening (SCR) and Day 3 are presented. Findings were determined to be normal, abnormal CS, and NCS by the investigator.|Screening (SCR) and at Day 3|Safety Population|||Participants|||Number
2684581|NCT01366521|Secondary|Number of Participants With Levels of Anti-mepolizumab Antibodies at Indicated Time Points|Blood samples were collected for the determination of anti-mepolizumab antibodies by antibody detection (AD) and antibody neutralisation (AN) assay. For participants who prematurely withdrew from the study and had been dosed, immunogenicity testing occurred (if possible) at the time of premature withdrawal and at 16 weeks after dosing (or the end of the study, whichever came first). Serum was tested for the presence of anti-mepolizumab antibodies using the currently approved analytical methodology incorporating screening, confirmation and titration steps. Samples confirmed positive for the presence of anti-mepolizumab antibodies in the original assay were tested for the presence of neutralizing antibodies.|Day 1, Day 112 and Day 140|Safety Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).|||Participants|||Number
2684582|NCT01366521|Secondary|Change From Baseline in Heart Rate Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140|Vital sign measurements including heart rate (HR) was measured at Baseline (Pre-dose Day 1), Day 1 (30 minutes, 1 h, 2 h), Day 28 (pre-dose, 30 minutes, 1 h, 2 h), Day 56 (pre-dose, 30 minutes, 1 h, 2 h), Day 84, Day 112 and follow-up (Day 140).|Baseline (Day 1 pre-dose) and at Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140|Safety Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).|||beats per minute (BPM)||Standard Deviation|Mean
2684583|NCT01366521|Secondary|Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Assessed at Baseline, Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140|Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured at Baseline (pre-dose Day 1), Day 1 (30 minutes, 1 h, 2 h), Day 28 (pre-dose, 30 minutes, 1 h, 2 h), Day 56 (pre-dose, 30 minutes, 1 h, 2 h), Day 84, Day 112 and follow-up (Day 140).|Baseline (Day 1 pre-dose) and at Day 1, Day 28, Day 56, Day 84, Day 112 and Day 140|Safety Population. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2684584|NCT01366521|Secondary|Number of Participants With Hematology Laboratory Parameters Outside the Normal Range at Following Treatment|Hematology laboratory parameters included platelet count, red blood cells (RBC) count, white blood cell (WBC) count, hemoglobin, hematocrit, reticulocyte count, mean corpuscle volume (MCV), mean corpuscle hemoglobin (MCH), mean corpuscle hemoglobin concentration (MCHC), neutrophils, segmented neutrophils (SN), total neutrophils (TN), lymphocytes, monocytes, eosinophils and basophils assessed at Baseline, Weeks 4, 8, 12 and 20. Hematology abnormalities outside the normal range (high and low values) at any time post-Baseline are presented.|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140 (follow-up visit)|Safety Population|||Participants|||Number
2684585|NCT01366521|Secondary|Number of Participants With Clinical Chemistry Parameters Outside the Normal Range Following Treatment|Clinical chemistry laboratory parameters included blood urea nitrogen (BUN), potassium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TB) and direct bilirubin, creatinine, chloride, uric acid, glucose, total carbondioxide (CO2), gamma glutamyltransferase (GGT), albumin, sodium, calcium, alkaline phosphatase (ALP) and total protein assessed at Baseline, Weeks 4, 8, 12 and 20. Laboratory abnormalities outside the normal range (high and low values) at any time post-Baseline are presented.|Baseline (Day 1 pre-dose), Weeks 4, 8, 12 and 20|Safety Population: all participants randomized to treatment who received at least one dose of study medication. Only those participants available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).|||Participants|||Number
2684586|NCT01366521|Primary|Terminal Half-life (t½) From Pre-dose (Day 1) to Day 140 for Mepolizumab|Terminal half-life (t1/2) was estimated by modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters for mepolizumab from the sparse sampling. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population|||Days||95% Confidence Interval|Mean
2684587|NCT01366521|Primary|Time to Maximum Plasma Concentration (Tmax) From Pre-dose (Day 1) to Day 140 for Mepolizumab|Time to maximum plasma concentration was estimated by population modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population. Only those participants with the blood samples available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).|||hours||Full Range|Median
2684642|NCT01365624|Primary|AUClast (Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Time Point Post-dose||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose||||ng*hours/mL||Standard Deviation|Mean
2684588|NCT01366521|Primary|Maximum Plasma Concentration (Cmax) From Pre-dose (Day 1) to Day 140 for Mepolizumab|Maximum plasma concentration was estimated by population modelling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Blood samples for PK analyses of mepolizumab were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 h, 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PK Population. Only those participants with the blood samples available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).|||Nanogram per milliliter (ng/mL)||95% Confidence Interval|Geometric Mean
2684589|NCT01366521|Primary|Mean Area Under the Plasma-concentration Time Curve (AUC) Following SC and IV Administration of Mepolizumab|AUC of mepolizumab was estimated by population modeling techniques using non-linear mixed effect methods for the individual and population pharmacokinetic parameters from the sparse sampling. Individual cumulative plasma of mepolizumab AUC to Day 84 (cumAUC(0-day 84)), is the sum of the AUCs over each dosing interval after each of the three doses administered, for those participants with data up to Day 84. Individual cumulative plasma of mepolizumab AUC to Day 140 (cumAUC(0-day 140) is the sum of the AUCs over each dosing interval after each of the three doses administered plus the AUC post the last dose interval up to Day 140 (i.e. from Day 84 to Day 140). Blood samples for PK analyses were collected on dosing days (Days 1, 28 and 56) at pre-dose and 0.5 hour (h), 1 h and 2 h post-dose (time was relative to the end of infusion in the IV cohort) as well as on Days 3, 7, 70, 84, 112 and 140 (follow-up visit).|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|Pharmacokinetic (PK) Population: all participants randomized to treatment and who received at least one dose of study treatment and who have at least one PK sample taken and analyzed. Only those participants with the blood samples available at the indicated time points were analyzed (represented by n=X, X, X, X in the category titles).|||Nanogramper milliliter per hour(ng*h/mL)||95% Confidence Interval|Geometric Mean
2684590|NCT01366521|Primary|Number of Participants Who Achieved >=50% Eosinophil Repletion by Day 140|This summarizes the number of participants who returned to at least 50% of their Baseline blood eosinophil levels after maximum inhibition had been achieved and without any subsequent decrease in blood eosinophil levels. Blood samples were collected at Days 1, 3, 7, 28, 56, 70, 84, 112 and 140.|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PD Population|||Participants|||Number
2684591|NCT01366521|Primary|Time to Maximum Change in Blood Eosinophils Levels (Tmaxeos)|Blood samples were collected at Days 1, 3, 7, 28, 56, 70, 84, 112 and 140 to assess the time to first occurrence of maximum reduction from baseline in blood eosinophil levels between Day 1 pre-dose and last quantifiable study measurement.|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PD Population.|||Days||95% Confidence Interval|Mean
2684592|NCT01366521|Primary|Maximum Change From Baseline in Blood Eosinophils (Emax)|Blood samples were collected at Days 1, 3, 7, 28, 56, 70, 84, 112 and 140 to assess the maximum reduction from Baseline in blood eosinophils between Day 1 pre-dose and last quantifiable study measurement. Change from Baseline was calculated as the ratio of the post-Baseline value divided by the Baseline value. The maximum reduction from Baseline in eosinophils is represented by the minimum ratio to Baseline.|Days 1, 3, 7, 28, 56, 70, 84, 112 and 140|PD Population|||Giga units per liter (GI/L)||95% Confidence Interval|Geometric Mean
2684593|NCT01366521|Primary|Area Under the Blood Eosinophil Time Curve (AUEC) up to Day 84|Area under the absolute blood eosinophil time curve to Day 84 (AUECeos[0-day 84]) determined using the linear trapezoidal rule for subset of participants with blood eosinophil data to Day 84. Blood samples for the analyses of AUEC(eos) (0-day 84) were collected at Days 1, 3, 7, 28, 56, 70 and 84.|Days 1, 3, 7, 28, 56, 70 and 84|PD Population. Only participants with eosinophil data to Day 84 were analyzed.|||Giga unit per liter per day (GI*d/L)||95% Confidence Interval|Geometric Mean
2684594|NCT01366521|Primary|Change From Baseline in Blood Eosinophil Levels at Week 12 (Day 84)|Change from Baseline in blood eosinophils was calculated as the post-Baseline value minus the Baseline value. The change from Baseline in log-transformed blood eosinophil levels at Week 12 was analyzed using both a linear and non-linear (Imax) dose response models. The dose response was found to be non-linear and hence only the results of the non-linear model are presented. Mepolizumab 75mg IV assumed to equate to 100 mg SC within model. Prior to log10-transformation, zero values were imputed with half the minimum value across all dose groups and time points. An adjustment for Baseline eosinophil count was also incorporated into the model.|Baseline (Day 1 pre-dose) and Week 12|Pharmacodynamic (PD) Population: all participants randomized to treatment and who received at least one dose of study medication and who also had a Baseline PD or biomarker measurement and at least one post-treatment PD or biomarker measurement. Only participants who were available at the specified time point were analyzed.|||Proportion of Baseline blood eosinophil||95% Confidence Interval|Number
2684595|NCT01366495|Secondary|Proportion of Those Prescribed Highly Active Antiretroviral Therapy (HAART) Who Are Undetectable|To determine if a promising, theory driven, case management based strategy (Project Bridge), will be utilized by individuals with HIV recruited through community corrections.|6,12,18-months|We were unable to obtain official medical records from treatment clinics.||||||
2684596|NCT01366495|Secondary|Retention in Community HIV Treatment|Number of Days with Retention in Community HIV Treatment|18 months||||days||Standard Deviation|Mean
2684597|NCT01366495|Primary|Number of Participants That Entered Community HIV Treatment|Number of Participants That Entered Community HIV Treatment (yes versus no) at the 3-month post baseline follow-up period.|3-months||||Participants|||Count of Participants
2684598|NCT01366495|Primary|Number of Participants Willing to Undergo Rapid HIV Testing|"Aim 1: To determine the willingness of the community corrections population to undergo HIV testing (Seek).~Aim 1a: To compare a strategy of rapid HIV testing on site in community corrections (probation and parole offices) to referral to an off site community HIV testing location with a randomized control study (Test)."|Baseline||||Participants|||Count of Participants
2684643|NCT01365624|Primary|Tmax (Time to Reach Maximum Plasma Concentration)||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose||||hours||Full Range|Median
2684644|NCT01365624|Primary|Cmax (Maximum Plasma Concentration)||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose||||ng/mL||Standard Deviation|Mean
2684599|NCT01366443|Primary|Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus|Patients underwent two assessments to determine positive or negative membrane rupture status: (1) Standard clinical assessment using fluid leaking from the cervical os, or two of the following; pooling, positive nitrazine test, or ferning and (2) A new combination immunoassay ROM Plus containing a combination of monoclonal and polyclonal antibodies to Placental Protein 12 (PP12) and Alpha-fetoprotein (AFP). Then, membrane rupture status was determined by chart review for reference based on a post delivery patient chart review by an experienced physician blinded to ROM Plus results.|1 week|Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes who underwent all three assessments.|||participants|||Number
2684600|NCT01366417|Primary|Antimicrobial Efficacy|Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 10 minutes after a single application of test material relative to the baseline bacterial count.|10 minutes after treatment|Subjects whose Treatment Day Baseline bacterial counts met qualification criteria|||log 10 colony forming units / cm^2||95% Confidence Interval|Mean
2684601|NCT01366417|Primary|Antimicrobial Efficacy|Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 30 seconds after a single application of test material relative to the baseline bacterial count.|30 seconds after treatment|subjects whose treatment day baseline microbial count met the qualification criteria and completed all assessments.|||log 10 colony forming units / cm^2||95% Confidence Interval|Mean
2684602|NCT01366209|Primary|Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52||52 weeks|Intent to Treat all randomized Patient|||percentage of patients|||Number
2684603|NCT01366196|Other Pre-specified|Numerical Pain Rating Scale Score With Physical Therapy on Postoperative Day 1|Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.|Postoperative Day 1 with Physical Therapy||||units on a scale||Standard Deviation|Mean
2684604|NCT01366196|Other Pre-specified|Numerical Pain Rating Scale Score on Postoperative Day 1 at Rest|Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.|Postoperative Day 1 at rest||||units on a scale||Standard Deviation|Mean
2684605|NCT01366196|Other Pre-specified|Numerical Pain Rating Scale Score on Day of Surgery|Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.|Day of Surgery||||units on a scale||Standard Deviation|Mean
2684606|NCT01366196|Secondary|Oral Analgesic Supplementation Use|Tabulate number of patients that used supplemental oral analgesics|Day of surgery||||Participants|||Count of Participants
2684607|NCT01366196|Primary|Patient Controlled Analgesia (PCA) Hydromorphone Usage||Postoperative day 1||||mL||Standard Deviation|Mean
2684608|NCT01366092|Secondary|Immunologic Effects of Low-dose Daily SC IL-2: Treg/Tcon Ratio|Blood samples were collected throughout the patient's 12 weeks of IL-2 treatment and after the 4 week hiatus. The ratio between CD4+CD25+FOXP3+ regulatory T cells (Treg) and CD4 conventional T cell (Tcon) counts were measured.|16 weeks of study follow-up||||ratio||Inter-Quartile Range|Median
2684609|NCT01366092|Secondary|Immunologic Effects of Low-dose Daily SC IL-2: Treg Cell Counts|Blood samples were collected throughout the patient's 12 weeks of IL-2 treatment and after the 4 week hiatus. The CD4+CD25+FOXP3+ regulatory T cells (Treg) counts were measured.|16 weeks of study follow-up||||cell count/ uL||Inter-Quartile Range|Median
2684610|NCT01366092|Secondary|Overall Survival and Progression-free Survival|Overall survival (OS) and progression-free survival (PFS) were calculated using the Kaplan-Meier method. OS was defined as from the study entry to death from any cause. Patients who were alive or lost to follow-up were censored at the time last seen alive. PFS was defined from the study entry to disease relapse or progression or death from any cause, whichever occurred first.|2 years from start of IL-2||||probability|||Number
2684611|NCT01366092|Secondary|Prednisone Taper With IL-2 Therapy|Participants had their steroid dose assessed at weeks 6, 12,16, and every 8 weeks while on extended duration IL-2 therapy.|End of treatment after 16 weeks or most recent follow-up date for patients on extended|Participant's steroid taper was measured using their steroid dose at the start of therapy and their dose at the end of 16 weeks. For participants who continued on extended duration therapy, their final steroid dose was determined at the time of stopping treatment or, if still ongoing, the last clinic visit at the time of data analysis.|||percent taper||Full Range|Mean
2684612|NCT01366092|Secondary|Toxicity of 12-week Course of Low-dose SC IL-2 Therapy|Participants were evaluated at clinical visits for toxicities related to IL-2 throughout their 12-week treatment course|12 weeks|Grade 2 or higher, related to IL-2, adverse events (AE) were recorded for participants during their 12-week IL-2 treatment course. AE's were evaluated based on the CTCAE version 4.0.|||Grade 2 or higher related AEs|||Number
2684613|NCT01366092|Primary|Overall Response Rate of Low-dose Daily SC IL-2 in Steroid-refractory cGVHD|Participants were evaluated according to the cGVHD NIH Consensus criteria at baseline, 6 weeks, and 12 weeks on study. Per cGVHD NIH Consensus criteria, cGVHD involved organ systems are given a grade 0-3 and an overall cGVHD score, from 0-10, is given. Complete Response is defined as resolution of all reversible manifestations in each organ or site of cGVHD. A partial response is defined as an improvement in measure at least one organ or site, or decrease in global ratings by at least a 2-point change on the 10-point scale, without progression measured at any other organ or site. Non-responders have no change in cGVHD meeting criteria for either partial response or disease progression. Progressive disease is defined as an increase in organ or site scales (1-point change on a 3-point scale) or 2- to 3-point increase on the global cGVHD ratings. Clinical worsening of cGVHD is not synonymous with progressive cGVHD per NIH criteria.|Baseline, 6 weeks, and 12 weeks|33 of 35 patients were evaluable for response criteria. To be evaluable, patients had to receive at least 6 weeks of daily IL-2 and had their disease re-assessed.|||participants|||Number
2684614|NCT01365910|Secondary|Number of Patients With Each Worst‐Grade Toxicity|"Count of patients according to the worst‐grade toxicity experienced by each, where worst‐grade toxicity is per NCI common toxicity criteria: grade 1= mild; grade 2 = moderate; grade 3 = severe; grade 4 = life‐threatening; grade 5 = death~Assessed: days 1 &15 of cycle 1; day 1 of each subsequent 28-day cycle; at 30-day follow-up for two years"|date on‐study up to 2 years following final dose of study|Total number of patients reported with any toxicity|||participants|||Number
2693461|NCT01294748|Secondary|Device Success|Achievement of a final in-stent residual diameter stenosis of <50% (by QCA), using the assigned device only.|8 hours||||percentage of participants|||Number
2684616|NCT01365910|Secondary|Progression-free Survival|Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring. Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.|Every 3 months, up to 2 years|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where either death or progression is an event, with censoring for non‐progressed, non‐expired patients at greater of off‐study date or last known alive date.|||days||95% Confidence Interval|Median
2684617|NCT01365910|Primary|Overall Response Rate (Complete Response + Partial Response) With a Target of at Least 15%|Per Response Evaluation in Solid Tumors (RECIST) criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. Defined as the CR + PR recorded from the start of the treatment until disease progression/recurrence, the exact two-sided 95% confidence intervals will be reported.|Baseline and every 8 weeks, up to 2 years|All patients are included in the analysis on intention‐to-treat basis. Analysis is by Kaplan‐Meier method, where death is an event, with censoring for non‐expired patients at greater of off‐study date or last known alive date.|||percentage of target lesions||95% Confidence Interval|Median
2684618|NCT01365845|Secondary|Assessment of Cardiac Function Markers|Assess levels of cardiac function markers Troponin and Brain Naturietic Peptide before and after treatment.|after treatment|||||||
2684619|NCT01365845|Secondary|Assessment of Longterm Side Effects and Disease Specific End Points.|"Assess late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, soft tissue fibrosis, rib fracture, and secondary malignancies.~Analyze local control, progression-free survival, and overall survival."|1 month following completion of treatment, then every 6 months for 5 years, then annually thereafter.|||||||
2684620|NCT01365845|Secondary|Assessment of Acute Side Effects|Assess acute toxicities including pericarditis, pneumonitis, dermatitis, fatigue, and nausea.|Participants will be assessed weekly during radiation therapy for an expected average of 7 weeks.|||||||
2684621|NCT01365845|Secondary|Secondary Dosimetric Endpoint|Assess improvements in other dosimetry endpoints including lung dose (mean lung dose, V20, V5), heart dose (mean heart, V20, V5), mean dose to the thyroid, mean esophageal dose, D95 coverage for axillary, supraclavicular and internal mammary nodes, maximal spinal cord dose (Dmax) and skin Dmax.|2 weeks prior to starting radiation therapy.|||||||
2684622|NCT01365845|Primary|Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE)|A reduction of 50% in heart volume exposed to radiation doses ≥ 5 Gy/CGE was considered preferred outcome in this study plan.|2 weeks prior to starting radiation therapy.||||% of heart receiving >= 5 Gray (Gy)||Full Range|Median
2684623|NCT01365819|Other Pre-specified|Reduction in Cigarette Smoking|3) To determine whether varenicline reduces cigarette smoking more than placebo among cigarette smoking MA dependent participants.|9 weeks|This analysis includes a sub-population of participants in both conditions who smoked any cigarettes during treatment. Results are model fitted number of cigarettes smoked per week at baseline and at week 9.|||average number of cigarettes|average number of cigarettes|Standard Deviation|Mean
2684624|NCT01365819|Other Pre-specified|Reduced MA Withdrawal Symptoms|2) To determine whether varenicline reduces MA withdrawal symptoms more than placebo among MA- dependent participants over the course of the trial.|9 weeks|This outcome was not assessed.||||||
2684625|NCT01365819|Other Pre-specified|Prevalence of Relapse Following Initiation of Abstinence During Treatment|1) The number of participants who achieve MA abstinence and subsequently relapse to MA use during treatment by condition (varenicline, placebo) during the outpatient treatment period.|7 weeks|This analysis presents the number of participants in each condition who achieved abstinence during treatment and later relapsed.|||Participants|||Count of Participants
2684626|NCT01365819|Secondary|Number of Days Retained in Trial|Secondary aims will compare treatment retention among participants randomly assigned to receive varenicline or placebo|9 weeks|This outcome was not assessed.||||||
2684627|NCT01365819|Primary|End of Treatment Abstinence|The primary analysis will compare two weeks continuous MA abstinence at end of treatment during weeks 8 and 9 among participants randomly assigned to receive varenicline versus those randomly assigned to receive placebo.|9 weeks||||Participants|||Count of Participants
2684628|NCT01365793|Secondary|Intelligence Quotient (IQ) Testing|IQ was assessed with the WASI (6-18 year olds) or WPPSI-III (3-5 year olds) at the 3 month follow-up visit. The Wechsler Abbreviated Scale of Intelligence (WASI) is a measure of IQ designed for individuals aged 6 to 89. The WASI includes four subtests; the Block Design and Matrix Reasoning tests measure Performance IQ, and the Vocabulary and Similarities tests measure Verbal IQ. Full scale IQ was computed from these scores and used for analyses. Scores typically vary from 75 to 135 with higher scores representing a better outcome.|3 months|All randomized subjects aged 3 years and older with 3-month follow-up and successful completion of IQ testing.|||IQ points||Standard Deviation|Mean
2684629|NCT01365793|Secondary|Mean Scores on Tests of Memory Capacity 3 Months After Recovery From DKA.|Contextual memory was assessed via color and spatial-position tasks. Color-Task: black-ink items on a white square background were shown on a computer screen with a colored border. Subjects were asked to remember the item and the item's border color. Items were shown for 1 second, followed by a 1-second interval in which a fixation point was shown. Then, subjects were given a self-paced recognition test including studied drawings and new drawings shown in random order with no color border. Subjects determined if they had seen the drawing before. For recognized drawings, subjects reported the previously shown border color. Spatial-Position task: identical to the color task except that the items instead varied in their spatial position on the computer screen. The item-context association rate is the rate of correct item-color and item-spatial position recalled over the total of previously viewed items correctly recognized. Score range: 0-1 with higher scores indicating a better outcome.|3 months|All randomized subjects aged 6 years old and older with 3-month follow-up and successful completion of memory score tests, and d-prime (a measure of chance agreement) >0.50|||Item-context association rate||Standard Deviation|Mean
2684630|NCT01365793|Secondary|Hourly Improvement in Forward and Backward Digit Span Scores During DKA Treatment (Mean Difference Per Hour)|The Digit Span subtest is adapted from the Wechsler Intelligence Scale for Children, 4th version (WISC-IV) and it assesses working memory. It consists of a Digit Span Forward task in which individuals are asked to repeat numbers in the same sequence as they were presented verbally and a Digit Span Backward task in which participants repeat the numbers in the reversed order to which they were heard. Each task yields a score ranging from 0 to 16. Higher scores represent better outcomes for this test. The trajectory of digit span scores during the course of the hospitalization was used to assess improvements in mental status and whether these varied systematically as a function of treatment protocol. Digit span measurements were collected every four hours during waking hours (7AM to 10PM). The measure analyzed is the average linear change in scores between enrollment and either 24-hours or DKA resolution, whichever occurred first.|24 hours|All randomized patients with digit span measured during DKA|||Digit Span Change per Hour||Standard Error|Mean
2684631|NCT01365793|Secondary|Frequency of Clinically Apparent Brain Injury|Deterioration in neurological status requiring interventions such as hyperosmolar therapy or endotracheal intubation, or resulting in death. This outcome was determined by an adjudication committee.|24 hours|All randomized patients.|||Participants|||Count of Participants
2684632|NCT01365793|Primary|the Number of Participants With Glasgow Coma Score (GCS) < 14 Within the First 24 Hours of Treatment for Diabetic Ketoacidosis (DKA)|The primary outcome is the binary indicator that a patient's GCS score drops below 14 (i.e. abnormal score) within the first 24 hours of treatment of DKA. There will be two treatment factors: sodium concentration of re-hydration fluids and rate of rehydration. These effects will be tested separately, using the Mantel-Haenszel chi-square test, stratified by hospital, and by the other main factor.|24 hours|Patients with a GCS of 14 or 15 at randomization|||Participants|||Count of Participants
2684633|NCT01365650|Primary|MRT (the Mean Residence Time)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine||||hours||Standard Deviation|Mean
2684634|NCT01365650|Primary|t1/2z (the Terminal Half-life, Where Possible)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine||||hours||Standard Deviation|Mean
2684635|NCT01365650|Primary|AUC 0-∞ (the AUC From Time Zero to Infinity, Where Possible)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine||||ng*h/mL||Standard Deviation|Mean
2684636|NCT01365650|Primary|AUC 0-t (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Post-dose)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine||||ng*h/mL||Standard Deviation|Mean
2684637|NCT01365650|Primary|Tmax (the Time to Maximum Concentration)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine||||hours||Full Range|Median
2684638|NCT01365650|Primary|Cmax (the Maximum Observed Plasma Concentration)|PK analysis by standard model was performed by a pharmacokineticist using model-independent analysis methods in WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each time, together with individual plasma concentrations of ketorolac.|Blood samples for PK analyses were obtained at pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 hours post administration of ketorolac tromethamine||||ng/mL||Standard Deviation|Mean
2684639|NCT01365624|Primary|MRT (Mean Residence Time)||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose|Two subjects had abnormally low plasma ketorolac concentration-time profiles that were inconsistent with the rest of the elderly population.|||hours||Standard Deviation|Mean
2684640|NCT01365624|Primary|t1/2z (Terminal Half-life)||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose|Two subjects had abnormally low plasma ketorolac concentration-time profiles that were inconsistent with the rest of the elderly population.|||hours||Standard Deviation|Mean
2684641|NCT01365624|Primary|AUC (Area Under the Plasma Concentration-time Profile From Time 0 to Infinity||Blood samples for PK analyses were obtained at pre-dose (15 minutes prior to ketorolac administration), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour and 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours and 24 hours post-dose|Two subjects had abnormally low plasma ketorolac concentration-time profiles that were inconsistent with the rest of the elderly population.|||ng*hours/mL||Standard Deviation|Mean
2684646|NCT01365611|Primary|t1/2z (the Terminal Half-life of Ketorolac Tromethamine, Where Possible)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6|The half-life could not be estimated for a subject due to the nature of the subject's PK profile.|||hours||Standard Deviation|Mean
2684647|NCT01365611|Primary|AUC Inf (the AUC From Time Zero to Infinity, Where Possible)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6|The half-life could not be estimated for a subject due to the nature of the subject's PK profile.|||ng*hours/mL||Standard Deviation|Mean
2684648|NCT01365611|Primary|AUC 0-t (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Post-dose of Ketorolac Tromethamine).||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6||||ng*hours/mL||Standard Deviation|Mean
2684649|NCT01365611|Primary|Tmax (the Time to Maximum Concentration of Ketorolac Tromethamine)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6||||hours||Full Range|Median
2684650|NCT01365611|Primary|Cmax (the Maximum Observed Plasma Concentration of Ketorolac Tromethamine)||PK parameters were determined using the following blood sampling times: pre-dose (within 10 minutes of ketorolac tromethamine administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 15 and 24 h post administration of study drug on Days 1 and 6||||ng/mL||Standard Deviation|Mean
2684651|NCT01365585|Secondary|Change From Baseline in Borg Dyspnea Index at Year 1, 2, 3 and 4|Borg dyspnea scale: 10-point scale where following scores stands for severity of dyspnea: 0=no breathlessness at all;0.5=very very slight (just noticeable); 1=very slight; 2=slight breathlessness; 3=moderate; 4=some what severe; 5=severe; 7=very severe breathlessness; 9=very very severe (almost maximum) and 10=maximum.|Baseline, Year 1, 2, 3, 4|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. 'n' included those participants who were evaluable for this measure at specified time points.|||units on a scale||Standard Deviation|Mean
2684652|NCT01365585|Secondary|Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at Year 1, 2, 3 and 4|PCWP was measured by pulmonary artery catheterization and provided an indirect measure of left atrial pressure.|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.||||||
2684653|NCT01365585|Secondary|Change From Baseline in Cardiac Index (CI) at Year 1, 2, 3 and 4|CI: calculated as COsys divided by BSA.|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.||||||
2684654|NCT01365585|Secondary|Change From Baseline in Pulmonary Vascular Resistance (PVR) at Year 1, 2, 3 and 4|PVR: calculated by subtracting PCWP from mPAP and dividing by cardiac output in pulmonary circulation (COpulm).|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.||||||
2684655|NCT01365585|Secondary|Change From Baseline in Mean Pulmonary Arterial Pressure (mPAP) at Rest at Year 1, 2, 3 and 4|mPAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.||||||
2684656|NCT01365585|Secondary|Change From Baseline in Right Atrial Pressure (RAP) at Year 1, 2, 3 and 4|RAP was measured using a pressure transducer positioned at the mid-axillary line with the participant in the supine position.|Baseline, Year 1, 2, 3, 4|Data was not summarized because results were available for very few participants and were insufficient for analysis.||||||
2684657|NCT01365585|Secondary|Change From Baseline in New York Heart Association, World Health Organization (NYHA/WHO) Functional Class in Participants With Pulmonary Arterial Hypertension (PAH) at Year 1, 2, 3 and 4|NYHA/WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity) to Class IV (can not perform a physical activity without any symptoms, dyspnea at rest). Improvement=reduction in functional class, deterioration = increase in functional class, no change = no change in functional class. Number of participants in each functional class was reported.|Baseline, Year 1, 2, 3, 4|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure. Here, 'n' included those participants who were evaluable for this measure at specified time points.|||participants|||Number
2684658|NCT01365585|Primary|Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 4|6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline, Year 4|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||meter||Standard Deviation|Mean
2684659|NCT01365585|Primary|Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 3|6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline, Year 3|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||meter||Standard Deviation|Mean
2684660|NCT01365585|Primary|Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 2|6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline, Year 2|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||meter||Standard Deviation|Mean
2684661|NCT01365585|Primary|Change From Baseline in 6-Minute Walk Distance (6MWD) at Year 1|6MWD was the distance that a participant could walk in 6 minutes. Participants were asked to perform the test at a pace that was comfortable to them, with as many breaks as they needed.|Baseline, Year 1|Analysis population included all participants who satisfied the eligibility criteria for the study. Here, 'N' (number of participants analyzed) included those participants who were evaluable for this measure.|||meter||Standard Deviation|Mean
2684662|NCT01365546|Secondary|Post-operative Efficacy Assessment|Post-operative efficacy was assessed by the investigator, covering the time period from the end of the procedure up to 24 hours following the last infusion of study medication. This assessment took the post-operative bleeding and oozing into consideration|up to 30 days||||participants|||Number
2684663|NCT01365546|Secondary|Assessment of Intra-operative Hemostatic Efficacy|The efficacy of Wilate during surgical procedures was assessed by a 4-point ordinal efficacy scale by the surgeon at the end of the surgical procedure and took the predicted versus actual blood loss and transfusion requirements into consideration. Outcome measure 1 takes the results of outcome measure 2 and 3 into consideration and is an overall assessment covering intra- and post-operative efficacy.|1 Day||||participants|||Number
2684664|NCT01365546|Primary|Overall Hemostatic Efficacy (Success or Failure) of Wilate, Based on the Intra-operative Assessment of the Surgeon and the Post-operative Assessment by the Investigator Using a 4-point Ordinal Efficacy Scale.|Efficacy of Wilate in surgical procedures was assessed intra-operatively by the surgeon and post-operatively by the investigator. The IDMC additionally conducted an independent adjudication of all hemostatic efficacy results ('secondary adjudication') and adjudicated the surgeons'/investigators' assessments of the intra- and post-operative assessments where there were discrepancies between the two assessments ('primary adjudication'). It was specified in the SAP that the study will be terminated early and success claimed if the two-sided 98.75% confidence interval (CI) for the overall success rate excludes and is greater than 0.60 (equivalent to 25 or more successes out of the 30 procedures).|30 Days||||participants||95% Confidence Interval|Number
2684665|NCT01365507|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.|||Episodes/100 years of patient exposure|||Number
2684666|NCT01365507|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.|||Episodes/100 years of patient exposure|||Number
2684667|NCT01365507|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 26 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product.|||Events/100 years of patient exposure|||Number
2684668|NCT01365507|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). For 2 subjects baseline values were missing, hence not included in the analysis.|||mmol/L||Standard Deviation|Mean
2684669|NCT01365507|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 26 weeks of treatment.|Week 0, week 26|The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2684670|NCT01365494|Secondary|Percentages of Subjects Reporting Adverse Events (AEs)|Adverse events (AEs) were collected for 7 days following administration of each study vaccination or until time of next vaccination (whichever occurred sooner). All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects during the study were collected throughout the study period and all AEs were unsolicited.|All reported SAEs and medically attended AEs or AEs that resulted in the premature withdrawal of subjects were collected up to 42 days after first vaccination. Adverse events were collected throughout the study period|Safety population- All subjects in the Exposed population who provide post vaccination safety data and as vaccinated (as treated)|||percentages of subjects|||Number
2684671|NCT01365494|Secondary|Ratio of GMCs in Study Groups (Zagreb/Essen Schedules) on Days 7 and 42 as Measured by RVNA Geometric Mean Concentrations|Immunogenicity was measured as the ratio of GMCs of RVNA titer , evaluated using the rapid fluorescent focus inhibition test, on Days 7 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedules|Day 0, Day 7, Day 14 and Day 42|Full Analysis Set- All subjects in the exposed population who provided at least one evaluable serum sample and as randomized|||IU\ml||95% Confidence Interval|Geometric Mean
2684672|NCT01365494|Secondary|Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Zagreb and Essen Groups at Days 7, 14 and 42|Immunogenicity was measured as the percentage of subjects who achieved anti-RVNA titer ≥0.5 IU/mL, at days 0, 7, 14 and 42 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.|Study day 7, 14 and 42|Full Analysis Set- All subjects in the exposed population who provided at least one evaluable serum sample and as randomized|||Percentages of Subjects|||Number
2700349|NCT01243320|Primary|Change in Albumin Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||g/dL||95% Confidence Interval|Mean
2684673|NCT01365494|Primary|Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Each of the Zagreb and Essen Groups on Study Day 14|Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and on study day 14 as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule|On Day 0 and Day 14|Per Protocol Set-All subjects in the FAS (Full analysis set) population who:correctly receive the vaccine, provide evaluable serum sample at day 14, and have no major protocol violation as defined prior to analysis|||IU/mL||95% Confidence Interval|Geometric Mean
2684674|NCT01365481|Secondary|Percentage of Chronic Kidney Disease (CKD) Patients Who Had Estimated Glomerular Filtration Rate (eGFR) Decrease > 25 % From Baselinefrom Baseline to End Point|Percentage of Patients with CKD who had eGFR decrease > 25 % from Baseline|Baseline, End Point (Week 78 or Last observation carried forward (LOCF)|The Safety set (SAF) included all patients who received at least one dose of study medication.that has Chronic Kidney Disease (CKD)|||Percentage of patients|||Number
2684675|NCT01365481|Primary|Change From Baseline in Mean Sitting Diastolic Blood Pressure (MsDBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.|Baseline, End Point (Week 78 or Last observation carried forward (LOCF)|The Full Analysis set (FAS) included all patients who entered the treatment period. ) This OM looked at the Valsartan + Antihypertensive and Valsartan alone for ALL patients and did not break up the analysis between CKD and non-CKD patients.|||millimeter(s) of mercury (mmHg)||Standard Deviation|Mean
2684676|NCT01365481|Secondary|Percentage of Chronic Kidney Disease (CKD) Patients Who Had >=50% Reduction in Urine Albumin/Creatinine Ratio (UACR) From Baseline to End Point|Percentage of Patients with CKD who had Urine albumin creatinine reduction >/= 50% from baseline|Baseline, End Point (Week 78 or Last observation carried forward (LOCF)|The Safety set (SAF) included all patients who received at least one dose of study medication that has Chronic Kidney Disease (CKD) only|||Percentage of patients|||Number
2684677|NCT01365481|Secondary|Number of Participants With MSSBP, MSDBP and (MSSBP and MSDBP Combined) < 95th Percentile for Gender, Age, and Height|Number of Participants with Mean sitting systolic (MSSBP) and mean sitting diastolic(MSDBP) blood pressure and both combined less than the 95th percentile for age, gender and height|End Point (Week 78 or Last observation carried forward (LOCF)|The Full Analysis set (FAS) included all patients who entered the treatment period. This analysis includes only participants with baseline MSSBP or MSDBP or (MSSBP or MSDBP combined) ≥95th percentile for gender, age and height. n analyzed is displayed in left column. This OM did not break up the analysis between CKD and non-CKD patients.|||Number of Participants|||Number
2684678|NCT01365481|Primary|Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at End Point (Week 78 or Last Observation Carried Forward (LOCF)|Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.|Baseline, End Point (Week 78 or Last observation carried forward (LOCF)|The Full Analysis set (FAS) included all patients who entered the treatment period. ) This OM looked at the Valsartan + Antihypertensive and Valsartan alone for ALL patients and did not break up the analysis between CKD and non-CKD patients.|||millimeter(s) of mercury (mmHg)||Standard Deviation|Mean
2684679|NCT01365468|Other Pre-specified|Physician's Global Assessment of Clinical Condition (PGA) of Skin Lesions|The Physician‟s Global Assessment of Clinical Condition (PGA) is a 7-point grading scale for the investigator's assessment of the overall extent of improvement or worsening of the patient‟s skin disease as compared to baseline. Responses must be confirmed by at least two assessments separated in time by at least 4 weeks. The grading ranges from 0 to 6; 0 is Completely clear where as 6 is for worse condition. A complete clinical response (CCR) requires a grading of 0 indicating the absence of disease (histological confirmation is not required). Grades 1, 2, and 3 constitute partial response, indicating improvement of at least 50 percent, but less than 100 percent improvement.|Screening, after course #3, #6, #12, #18, #24, End of Treatment (1 course = 28 days)|Study got terminated because of poor patient's accrual. Enrolled patients were less than planned number of patients required for analysis. Hence, planned analysis was not done.||||||
2684680|NCT01365468|Other Pre-specified|Number of Patients With Clinical Response|Clinical response is defined as improvement of function, performance status, or decrease in PN related pain persisting for at least 28 days on treatment.|Screening, Day 1, after course #3, #6, #12, #18, #24, End of Treatment (1 course = 28 days)|Study got terminated because of poor patient's accrual. Enrolled patients were less than planned number of patients required for analysis. Hence, planned analysis was not done.||||||
2684681|NCT01365468|Primary|Number of Patients With Adverse Events Assessed by Common Toxicity Criteria for Adverse Events (CTCAE) V.04|Adverse events were assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0. If CTCAE grading does not exist for an adverse event, the severity of mild, moderate, severe, and life-threatening, corresponding to grades 1 - 4 respectively, were used. CTCAE grade 5 (death) was not used in this study.|From the time ICF was signed until 28 days after End of Treatment (up to a maximum of 25 months)|The Safety Population consisted of all patients who received at least one dose of study treatment and had at least one post-baseline safety assessment.|||Patients|||Number
2684682|NCT01365468|Primary|Number of Patients With Objective Radiographic Responses Based on Volumetric MRI Measurements (In Stratum 2 Only)|"Response was assessed at the time that a follow up volumetric MRI scan is performed (after course 6 and then every 6 months and at the end of treatment).~Complete response (CR): complete resolution of all measurable or palpable PN for ≥ 28days and no appearance of new lesions.~Partial response (PR): A ≥ 20% reduction in the sum of the volume of all index PN lesions for ≥ 28days.~Stable disease (SD): A < 20% increase and < 20% decrease in the sum of the volume of all index PN lesions for ≥ 28days."|Screening, after course #6, then every 6 months and end of treatment(1 course=28days)|The Full Analysis Set (FAS) consisted of all enrolled patients.|||Patients|||Number
2695296|NCT01280604|Secondary|Low-density Lipoprotein (LDL)|LDL levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks||||milligram/deciliter||Standard Deviation|Mean
2684683|NCT01365468|Primary|Time to Disease Progression (TTP) Based on Change in Volumetric MRI Measurements in Children and Adults (In Stratum I Only)|This endpoint was planned to be analyzed for only Stratum 1 patients. Progression of disease defined as a ≥ 20% increase in the volume (by volumetric MRI) of at least one of the index plexiform neurofibromas (PN) compared to the pretreatment volume measured prior to the start of the current treatment phase.|Screening, after course #6, #12, #18, #24, End of Treatment(1 course=28days)|The Full Analysis Set (FAS) consisted of all enrolled patients.|||Days||95% Confidence Interval|Median
2684684|NCT01365455|Secondary|Number of Participants Who Developed Anti-secukinumab Antibodies|The development of anti-secunimubab anti-bodies would decrease a participant's ability to respond to secukinumab treatment.|Week 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||participants|||Number
2684685|NCT01365455|Secondary|Percentage of Participants Achieving PASI 75, PASI 90 and IGA Mod 2011 0 or 1 Response at Week 12 by Previous Exposure to Biologic Systemic Therapy or Anti-TNF-α Therapy and Failed to Respond to a Previous Biologic or Anti-TNF-α Therapy Psoriasis Therapy|PASI is an assessment of lesion severity & affected area into a single score:0(no disease)to 72(max. disease).Body is divided into 4 areas for scoring(head,arms,trunk,legs)each area is scored separately & then added for final PASI.For each area, % of skin involved is estimated:0(0%)to 6(90-100%)& severity is estimated by clinical signs, erythema,induration & desquamation;scale 0(none) to 4(max). Final PASI=sum of severity parameters for each area* area score weight of section(head:0.1,arms:0.2 body:0.3 legs:0.4).PASI 75, 90 is patients achieving≥75%or90% improvement from baseline.The IGA mod 2011 scale is static, exclusively to the patients disease at assessment,& not with any of the patient's previous disease states at other visits.The scores are:0=clear,1=almost clear,2= mild,3=moderate&4=severe.Response variables PASI 75,90, IGA mod 2011 0 or 1 response at wk 12 was scored versus previous psoriasis systemic therapy & response to previous biologic systemic therapy by treatment|Week 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of participants|||Number
2684686|NCT01365455|Secondary|Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Maintenance Period|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Week 12,24,36, & 52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of Participants|||Number
2684687|NCT01365455|Secondary|Percentage of Participants Who Achieved Dermatology Life Quality Index (DLQI) of 0 or 1 During Induction Period|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Week 4, 8, 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of Participants|||Number
2684688|NCT01365455|Secondary|Percentage Changes in the Dermatology Life Quality Index (DLQI) During Maintenance Period|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Week 12,24, 36 & 52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percent Change||95% Confidence Interval|Median
2684718|NCT01365052|Other Pre-specified|Percentage of Subjects Who Discontinued Due to an Adverse Event for Those Subjects Who Are Randomized and Take at Least One Dose of Investigational Product||10 days after randomization|Safety population|||Percentage of participants|||Number
2684719|NCT01365039|Primary|High Contrast, Distance logMAR Visual Acuity (VA)|Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint|4 visits over 3 months|All Eligible, Dispensed Eyes|||logMAR|Participants|Standard Deviation|Mean
2684720|NCT01365039|Primary|Slit Lamp Findings > Grade 2|Statistical non-inferiority of Slit Lamp Findings > Grade 2 at any visit between the Test and Control lenses|4 visits over 3 months|Over All Follow-up Visits, Eyes with Findings > Grade 2 (All Dispensed Eyes)|||eyes|Participants||Number
2684689|NCT01365455|Secondary|Percentage Changes in the Dermatology Life Quality Index (DLQI) During Induction Period|"The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). Not relevant is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment. A negative mean percentage change from baseline indicates improvement."|Baseline, Week 4, 8 & 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percent Change||95% Confidence Interval|Median
2684690|NCT01365455|Secondary|Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Maintenance Period|The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.|Week 12, 24, 36, 52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percent Change||Standard Deviation|Mean
2684691|NCT01365455|Secondary|Mean Percent Change From Baseline in EuroQOL 5-Dimension Health Status Questionnaire (EQ-5D) Health State Assessment (From 0 to 100) Induction Period|The EQ-5D is an instrument used to assess a participant's health status. The instrument includes a descriptive profile and a visual analog scale (VAS). The descriptive profile includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 3 response levels: no problems, some problems and severe problems. The VAS is a vertical scale that assesses the health status from 0 (worst possible health state) to 100 (best possible health state). This outcome measures the percent change in VAS score. Positive mean percent changes indicate improvement.|Baseline, Week 4,8, 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||percent change||Standard Deviation|Mean
2684692|NCT01365455|Secondary|Time to PASI 75 Response up to 12 Weeks|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (max). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 75 was defined as participants achieving ≥ 75% improvement from baseline.|Week 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||days||Inter-Quartile Range|Median
2684693|NCT01365455|Secondary|Percentage of Participants in Each IGA Mod 2011 Score Category Maintenance Period After Week 12 to Week 52|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.|Week 13,14,15,16,20,24,28,32,36,40,44,48,52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of participants|||Number
2684694|NCT01365455|Secondary|Percentage of Participants in Each IGA Mod 2011 Score Category up to Week 12 - Induction Period|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.|Baseline, Week 1,2,3,4,8,12,|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of participants|||Number
2684695|NCT01365455|Secondary|Mean Percent Change From Baseline in PASI Scores Maintenance Period After Week 12 to Week 52|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.|Week 13,14,15,16,20,24,28,32,36,40,44,48,52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percent change||Standard Deviation|Mean
2700350|NCT01243320|Primary|Change In Total Bilirubin Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||mg/dL||95% Confidence Interval|Mean
2684696|NCT01365455|Secondary|Mean Percent Change From Baseline in PASI Scores up to Week 12 - Induction Period|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). A negative mean percentage change indicates improvement.|Baseline, Week 1,2,3,4,8,12,|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percent Change||Standard Deviation|Mean
2684697|NCT01365455|Secondary|Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response Maintenance Period After Week 12 to Week 52|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (max). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 13,14,15,16,20,24,28,32,36,40,44,48,52|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of participants|||Number
2684698|NCT01365455|Secondary|Percentage of Participants Achieving PASI 50/75/90/100 Response or IGA 0 or 1 Response up to 12 Weeks Induction Period|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (max). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 50, 75, 90 and 100 were defined as participants achieving ≥ 50%, 75%, 90% or 100% improvement from baseline. The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe.|Week 1,2,3,4,8,12,|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of participants|||Number
2684699|NCT01365455|Secondary|Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo|The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. A reduction in score from baseline shows efficacy. Each question has a score of 0 (no symptoms) up to 10 (Severe symptoms)|Week 12|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Scores on a Scale||Standard Error|Mean
2684700|NCT01365455|Secondary|Number of Participants That Maintained the IGA Mod 2011 0 or 1 Response at 52 Weeks of Treatment for Participants Who Were IGA Mod 2011 0 or 1 Responders at Week 12|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1.|12 and 52 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||number of participants|||Number
2684701|NCT01365455|Secondary|Number of Participants That Maintained the Psoriasis Area and Severity Index (PASI) 75 Response at 52 Weeks of Treatment for Participants Who Were PASI 75 Responders at Week 12|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|12 and 52 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||number of participants|||Number
2684702|NCT01365455|Secondary|Percentage of Participants Who Achieved a PASI (Psoriasis Area and Severity Index) Score of 90 or Better at Week 12|PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 was defined as participants who achievied ≥ 90% improvement from baseline.|12 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of Participants|||Number
2684703|NCT01365455|Primary|Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1|The IGA mod 2011 scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe. Treatment success was defined as achievement of IGA mod 2001 score of 0 or 1. IGA score of 0 or 1 as an indicator of efficacy.|12 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of Participants|||Number
2684704|NCT01365455|Primary|Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks|A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).|12 weeks|Full analysis set (FAS): The FAS was comprised of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment assigned to at randomization. If the actual stratum was different to the assigned stratum in IRT, the actual stratum was used in analyses.|||Percentage of participants|||Number
2684705|NCT01365273|Primary|VAS Score for Pain After Dressing Removal|"Pain after the dressing removal measued with Visual Analogue Scale (VAS).0 = no pain till 100 = worst pain."|Visit 6, day 7|All subjects to post-randomization treatment and that provided some data for the primary endpoint were included in the ITT analysis.|||units on a scale||Standard Deviation|Median
2684706|NCT01365273|Primary|VAS Score for Pain During Dressing Removal|"Pain when half of the study product(s) has been removed measued with Visual Analogue Scale (VAS).0 = no pain till 100 = worst pain."|Visit 6, day 7|All included subjects to post-randomization treatment and that provided some data for the primary endpoint was included in the Intention To Treat analyses.|||units on a scale||Standard Deviation|Median
2684707|NCT01365273|Primary|VAS Score for Pain Before Dressing Removal|"Pain was measured with Visual Analogue Scale (VAS)(100 mm) measuring from 0 = no pain at one end to 100 = most intense pain imagaginable at the other end."|At visit 6, day 7|All subjects to post-randomization treatment and that provided some data for the primary endpoint were included in the ITT analysis.|||units on a scale||Standard Deviation|Median
2684708|NCT01365130|Secondary|Number of Patients Experienced a Toxicity Associated With Cabazitaxel for Patients With Metastatic Gastroesophageal Adenocarcinomas That Have Progressed After at Least One Line of Therapy for Metastatic Disease.|CTCAE version 4. It is noted that the time frame was approximately 7 months, taking into account the total amount of treatment patients received on this trial.|During treatment and through 30 days post treatment, approximately 7 months|Number of patients who experienced a toxicity on the trial. Not all toxicities may be related to study treatment.|||Participants|||Count of Participants
2684709|NCT01365130|Primary|Number of Patients Without Progression at 3 Months|Response will be assessed via RECIST 1.1 criteria|every three cycles approx every 63 days||||participants|||Number
2684710|NCT01365091|Primary|AUC From Time 0 Extrapolated to Infinite Time (AUC[0-inf]) for Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets|AUC=Area Under the Concentration-time Curve|Days 1, 2, and 3 of Periods 1 and 2|Participants who received study medication and were evaluable|||ng*h/mL||Standard Deviation|Mean
2684711|NCT01365091|Secondary|Number of Participants With Death as Outcome and Serious Adverse Events (SAEs)|SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.|Continuously, from screening through Day 1 to within 30 days of drug discontinuation on Day 1|All enrolled participants who receive study medication|||Participants|||Number
2684712|NCT01365091|Primary|AUC From Time 0 to Time of the Last Quantifiable Concentration (AUC[0-T])of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets|AUC=Area under the concentration-time curve|Days 1, 2, and 3 of Periods 1 and 2|Participants who received study medication and were evaluable|||pg*h/mL||Standard Deviation|Mean
2684713|NCT01365091|Primary|Maximum Observed Concentrations (Cmax) of Metformin, Saxagliptin, and 5-Hydroxy (5-OH) Saxagliptin as a Fixed-dose Combination (FDC) and as Individual Tablets||Days 1, 2, and 3 of Periods 1 and 2|Participants who received study medication and were evaluable|||μg/mL||Standard Deviation|Mean
2684714|NCT01365052|Other Pre-specified|Treatment Compliance - Duration of Exposure to Treatment in Days||10 days after randomization|Safety population|||Days||Standard Deviation|Mean
2684715|NCT01365052|Other Pre-specified|Treatment Compliance - Number of Capsules Taken||10 days after randomization|Safety population|||Capsules||Standard Deviation|Mean
2684721|NCT01364922|Secondary|Participant's Global Assessment of Study Drug at Final Evaluation|"The participant's overall impression of the study drug was obtained by having the participant answer the question How would you rate your overall response to the study medication? on a 5-point categorical scale: excellent; very good; good; fair; poor."|Double-blind baseline to Day 29|Double-blind intent to treat population; scores for participants with no post-randomization assessment were excluded from this analysis.|||participants|||Number
2684722|NCT01364922|Secondary|Participant's Global Assessment of Back Pain Status at Final Evaluation|"The participant's overall impression of their back pain status was obtained by having the participant answer the question Considering all the ways your chronic low back pain affects you, how are you doing today? on a 5-point categorical scale: very good (no symptoms and no limitation of normal activities); good (mild symptoms and no limitation of normal activities); fair (moderate symptoms and limitation of some normal activities); poor (severe symptoms and inability to carry out most normal activities); very poor (very severe symptoms which are intolerable and inability to carry out all normal activities)."|Double-blind baseline to Day 29||||participants|||Number
2684723|NCT01364922|Primary|Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)|The change from the double-blind randomization baseline (DB baseline: the last assessment before first dose in the double-blind period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from an ANCOVA model.|Double-blind baseline to Day 29|The analysis of the primary outcome measure included all randomized participants who received at least 1 dose of study drug during the double-blind period (double-blind intent-to-treat) and had at least 1 assessment during the double-blind period.|||scores on a scale||Standard Error|Least Squares Mean
2684724|NCT01364896|Primary|Number of Participants With High-grade Anal Dysplasia Lesions|High resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria|Baseline and 6 to 12 months||||participants|||Number
2684725|NCT01364896|Primary|Number of Participants Who Had One or More Anal Biopsies|High resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria|Baseline and 6 to 12 months||||participants|||Number
2684726|NCT01364896|Primary|Number of Participants With Abnormal Anal Cytology (ASC-US, ASC-H, LSIL, HSIL, Cancer)|High-resolution anoscopy with anal cytology testing|Baseline and 6 to 12 months||||participants|||Number
2684727|NCT01364896|Primary|Percent of Participants With HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and/or 58||Baseline and 6 to 12 months||||percentage of participants|||Number
2684728|NCT01364896|Primary|Number of Participants With Anal HPV of Any Type, Single Type, and Multiple Types|Anal (and vaginal for female participants) HPV PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58) using the SYBR-Green-based real-time PCR assay with a reverse line blot assay for genotyping of HPV in the positive samples and Taqman probe-based real-time PCR assays for quantification of individual HPV subtypes|Baseline and 6 to 12 months||||participants|||Number
2684729|NCT01364870|Primary|Self-reported Pain With Walking (From Iowa Gait Test)|"Subjects are instructed to walk as quickly as they safely can for 15 seconds. Their pain was assessed with a Numeric Rating Scale (where 0 is no pain and 20 is pain as bad as you can imagine)."|2 days post-op||||scores on a scale||Full Range|Median
2684730|NCT01364870|Primary|Self-Reported Pain With Movement|"While subject's knee extension is measured, they report their pain on 0-20 Numeric Rating Scale (where 0 is no pain and 20 is pain as bad as you can imagine)."|1 day post-op||||scores on a scale||Full Range|Median
2684731|NCT01364740|Other Pre-specified|Attitude Toward Device Use Questionnaire Scores|Questionnaire consisting of multiple questions, scored as 1 = disagree completely to 5 = agree completely, revealed the following mean scores|one night||||units on a scale||Standard Deviation|Mean
2684732|NCT01364740|Secondary|Oxygen Saturation|Mean oxygen saturation|One night||||percent||Standard Deviation|Mean
2684733|NCT01364740|Secondary|Hypopnea Index|Number of events/hour of sleep. Hypopneas scored without EEG arousals.|One night||||events/hour||Standard Deviation|Mean
2684734|NCT01364740|Secondary|Apnea Index|Number of events/hour of sleep|One night||||events/hour||Standard Deviation|Mean
2684735|NCT01364740|Primary|AHI|Apnea-Hypopnea Index (number of events/hour of sleep). Hypopneas scored without EEG arousals.|One night||||events/hour||Standard Deviation|Mean
2684736|NCT01364727|Secondary|Disease Control Rate (DCR)|"Disease control rate (DCR) is the sum of Complete Response (CR) rate + Partial Response (PR) rate + Stable Disease (SD) rate , and is expressed here as the sum of the Overall Response Rate (ORR = CR + PR) plus the Stable Disease (SD) rate, ORR + SD.~Response was assessed by the RECIST criteria, elaborated above."|2 years|Includes those participants with Complete Response (CR) plus those with Partial Response (PR), plus those with Stable Disease).|||Participants|||Count of Participants
2684737|NCT01364727|Secondary|Median Progression-free Survival (PFS)|Median Progression-free survival in patients with thymic malignancies treated with amrubicin|2 years|Some participants (2) continue to survive without progression, although a median and the 95% confidence interval (95% CI) for the 33 participants have been defined.|||Months||95% Confidence Interval|Median
2684738|NCT01364727|Primary|Overall Response Rate (ORR)|"Participants received amrubicin 35 mg/m2 IV days 1 to 3, every 3 weeks, until progression or toxicity.~Tumor response rate was assessed radiographically by the Response Evaluation Criteria In Solid Tumors (RECIST), and the overall response rate (ORR) was expressed as the sum of the Complete Response (CR) rate and the Partial Response (PR) rate.~RECIST criteria define when cancer patients improve (respond); stay the same (stable); or worsen (progression) during treatments. The criteria presume that linear measures are an adequate substitute for 2-dimensional (2D) methods and includes 4 response categories:~CR = Disappearance of all target lesions~PR = 30% decrease in the sum of the longest diameter of target lesions~Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions~Stable disease (SD) = Small changes that do not meet above criteria"|2 years|Includes those participants with Complete Response (CR) plus those with Partial Response (PR).|||Participants|||Count of Participants
2684754|NCT01364584|Secondary|Echocardiographic Measures - Stroke Volume|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||mL/beat||Standard Deviation|Mean
2684739|NCT01364649|Secondary|Number of Participants With Shifts in the CSFQ-14 From Abnormal to Normal at Each Week Assessed|The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. Normal sexual functioning is defined as a CSFQ-14 total score of >41 for women and >47 for men. Abnormal sexual functioning is defined as a CSFQ-14 total score of ≤41 for women and ≤47 for men. All subjects entered the study with abnormal sexual functioning. A shift to normal indicates that symptoms have improved.|Baseline and Weeks 1, 2, 4, 6 and 8|Participants from the FAS, defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. Last observation carried forward.|||number of participants|||Number
2684740|NCT01364649|Secondary|Change From Baseline in the CSFQ-14 Total Score at All Other Time Points Assessed|The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A positive change from Baseline indicates that symptoms have improved. The primary analysis was based on a mixed model for repeated measurements (MMRM) analysis of covariance with treatment, center, week, treatment-by-week interaction as fixed effects, Baseline CSFQ-14 total score-by-week as covariate, and a completely unstructured covariance matrix.|Baseline and Weeks 1, 2, 4 and 6|Participants from the FAS, defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure.|||scores on a scale||Standard Error|Least Squares Mean
2684741|NCT01364649|Primary|Change From Baseline in the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) Total Score at Week 8|The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A positive change from Baseline indicates that symptoms have improved. The primary analysis was based on a mixed model for repeated measurements (MMRM) analysis of covariance with treatment, center, week, treatment-by-week interaction as fixed effects, Baseline CSFQ-14 total score-by-week as covariate, and a completely unstructured covariance matrix.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure.|||scores on a scale||Standard Error|Least Squares Mean
2684742|NCT01364623|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) for Estradiol Following TBS-2|AUCt shown for single dose and AUCtau for multiple dose.|Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosing||||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2684743|NCT01364623|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) for Dihydrotestosterone Following TBS-2|AUCt shown for single dose and AUCtau for multiple dose.|Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosing||||ng*h/dL||Geometric Coefficient of Variation|Geometric Mean
2684744|NCT01364623|Primary|Medium Dose TBS-2 Multiple Dose Average Steady-state Concentration (Cavg) of Total Testosterone||-0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48h after Day 3 dosing||||ng/dL||Standard Deviation|Mean
2684745|NCT01364623|Primary|Bioavailability (Cmax) of Total Testosterone Through Pharmacokinetic Profiles|Cmax - maximum concentration of total testosterone observed after dosing of TBS-2|Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosing||||ng/dL||Geometric Coefficient of Variation|Geometric Mean
2684746|NCT01364623|Primary|Bioavailability (AUC0-t) of Total Testosterone Through Pharmacokinetic (PK) Profiles|Area under the concentration time curve from time zero to the last measurable concentration time point (AUC0-t) for single dose and AUCtau shown for multiple dose.|Based on blood samples collected -0.25, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 20, 23.5h relative to dosing||||ng*h/dL||Geometric Coefficient of Variation|Geometric Mean
2684747|NCT01364584|Secondary|Echocardiographic Measures - Lateral E:E'|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||ratio||Standard Deviation|Mean
2684748|NCT01364584|Secondary|Echocardiographic Measures - Lateral E'|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||centimeters/second||Standard Deviation|Mean
2684749|NCT01364584|Secondary|Echocardiographic Measures - Septal E:E'|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||ratio||Standard Deviation|Mean
2684750|NCT01364584|Secondary|Echocardiographic Measures - Septal E'|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||centimeters/second||Standard Deviation|Mean
2684751|NCT01364584|Secondary|Echocardiographic Measures - Mitral Valve Deceleration Time|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||milliseconds||Standard Deviation|Mean
2684752|NCT01364584|Secondary|Echocardiographic Measures - Mitral Valve E:A Wave Velocity|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||centimeters/second||Standard Deviation|Mean
2684753|NCT01364584|Secondary|Echocardiographic Measures - Mitral Valve E Wave Velocity|Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.|Baseline and 3 months||||centimeters/second||Standard Deviation|Mean
2700351|NCT01243320|Primary|Change In Total Protein Blood Levels|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||g/dL||95% Confidence Interval|Mean
2684759|NCT01364584|Secondary|Change From Baseline in Arterial Stiffness|Pulse wave velocity will be measured via sphygmocor before and after 3 months of study medication or placebo.|Baseline and 3 months|Data unable to be collected on all participants, hence the difference between the overall number of participants analyzed here and the actual number of participants who completed the study|||meters/second||Standard Deviation|Mean
2684760|NCT01364584|Secondary|Oxygen Uptake Kinetics Steady State Tau|Time to steady state oxygen consumption will be assessed in subject before and after 3 months of study medication or placebo.|Baseline and 3 months||||seconds||Standard Deviation|Mean
2684761|NCT01364584|Primary|Peak Oxygen Consumption (VO2 Peak)|Subjects' peak oxygen consumption (VO2 peak) will be tested on a stationary bike before and after 3 months of study medication or placebo.|Baseline and 3 months||||milliliters per kilogram per minute||Standard Deviation|Mean
2684762|NCT01364558|Primary|Comparison of the Absolute Bioavailability of Two Intranasal Diazepam Formulations.|"To calculate bioavailability we used the following formula:~Area Under the Curve (Intranasal Spray)*100/Area Under the Curve (Intravenous Injection)"|2 days||||Percentage of Bioavailability||90% Confidence Interval|Geometric Mean
2684763|NCT01364467|Secondary|Nasal Secretion Collection|To measure the biophysical properties of nasal secretions for improved mucus clearance.|10 minutes|Unable to analyze due to insufficient sample material||||||
2684764|NCT01364467|Secondary|Nasal Volume|Acoustic rhinometry is used to measure cross-sectional volume of the nasal cavity allowing the calculation of nasal volume.|15 Minutes||||Square centimeters||Standard Deviation|Mean
2684765|NCT01364467|Primary|Change in Subjective Nasal Scoring|The Sinus and Nasal Quality of Life Survey (SN-5) questionnaire assesses the impact of infection on nasal symptoms, emotion, and activity. The SN-5 is a 5-item scale with each item rated on a scale of worsening symptoms from 1 (none of the time) through 7 (all of the time). Items were averaged to yield a single score ranging from 1 (better outcomes) to 7 (worse outcomes). Scores were used to asses change in disease severity and the impact of interventions on subjective complaints from baseline to follow-up.|Baseline to 10 Minutes||||score on a scale||Standard Deviation|Mean
2684766|NCT01364428|Secondary|Rate of Nocturnal Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.|Week 0 to Week 22 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2684767|NCT01364428|Secondary|Rate of Confirmed Hypoglycaemic Episodes|Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.|Week 0 to Week 22 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Episodes/100 years of patient exposure|||Number
2684768|NCT01364428|Secondary|Rate of Treatment Emergent Adverse Events (AEs)|Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.|Week 0 to Week 22 + 7 days follow up|The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.|||Events/100 years of patient exposure|||Number
2684769|NCT01364428|Secondary|Change in Fasting Plasma Glucose (FPG)|Change from baseline in FPG after 22 weeks of treatment.|Week 0, Week 22|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 5 subjects baseline values were missing.|||mmol/L||Standard Deviation|Mean
2684770|NCT01364428|Primary|Change in Glycosylated Haemoglobin (HbA1c)|Change from baseline in HbA1c after 22 weeks of treatment|Week 0, Week 22|The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).|||percentage of glycosylated haemoglobin||Standard Deviation|Mean
2684771|NCT01364389|Secondary|Effect on Health-related Quality of Life||6 months|||||||
2684772|NCT01364389|Secondary|Comparison Between the Initial Response to AIN457 and ACZ885 and the Response After Re-dosing of AIN457 and ACZ885||6 months|||||||
2684773|NCT01364389|Secondary|Pharmacokinetics of AIN457 and ACZ885||Day 15|||||||
2684774|NCT01364389|Secondary|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths||6 months|Safety analysis set: This set included all participants who received at least one dose of study medication.|||Participants|||Number
2684775|NCT01364389|Secondary|Cumulative and/or Mean Steroid Dose Over a 6 Month Period||6 months|||||||
2684776|NCT01364389|Secondary|Number of Flares Over a 6 Month Period||6 months|||||||
2684777|NCT01364389|Secondary|Time to First Flare||6 months|||||||
2684778|NCT01364389|Secondary|Time to Complete Clinical Response|The time to complete clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a complete clinical response at Day 15. A participant was defined as a complete responder if the participant had: >70% reduction in patient global assessment VAS compared with baseline, morning stiffness < 30 min, CRP < 1.0 mg/dL and/or ESR < 30 mm/1st hr.|Day 15|PD analysis set|||Percentage of participants|||Number
2684804|NCT01363986|Secondary|Overall Survival|The number of participants surviving at the final visit.|Baseline, weekly for 3 weeks (pre-WBRT phase), Cycles 1 through 15 (treatment phase Weeks 1 through 15), and 4 weeks after Cycle 15 (Week 15) or the last dose of study treatment|ITT population; survival status of 1 participant was unknown at the final visit.|||participant|||Number
2684779|NCT01364389|Secondary|Time to Partial Clinical Response|"The time to partial clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a partial clinical response at Day 15. A participant was defined as a partial responder if the participant had:~>50% reduction in patient global assessment visual analogue scale (VAS) compared with baseline and morning stiffness < 60 minutes."|Day 15|PD analysis set|||Percentage of participants|||Number
2684780|NCT01364389|Primary|Polymyalgia Rheumatica Activity Score (PMR-AS)|The efficacy of a single dose of AIN457 and ACZ885 (canakinumab) was measured by the polymyalgia rheumatica activity score. A composite PMR-AS was developed from the following components: measure of C-reactive protein (CRP), measure of Erythrocyte Sedimentation Rate (ESR), assessment of early morning stiffness, assessment of the patient's elevation on upper limbs, patient's assessment of pain, and physician's global assessment of disease activity. Treatment effect was measured by the percent reduction in PMR-AS. N=3 for the ACZ885 arm because CRP values at Day 15 were missing for 2 participants.|Baseline, Day 15|Pharmacodynamic (PD) Analysis Set: This set included participants who received at least one dose of study medication and had no major protocol deviation that may impact the PD data.|||Percent reduction||Standard Error|Least Squares Mean
2684781|NCT01364298|Secondary|Number of Participants With Adverse Events (AEs)|An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered.|Day 7 up to Day 84 (+7 days)|Safety population included all the randomized participants who received at least one dose of study drug.|||participants|||Number
2684782|NCT01364298|Secondary|Percentage of Participants With at Least 30 and 50 Percent (%) Improvement in Numeric Pain Intensity Scale (NPIS) From Baseline at Day 84 (Week 12)|NPIS is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours.|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug.|||percentage of participants|||Number
2684783|NCT01364298|Secondary|Number of Participants With Various Health Conditions Based on Clinical Global Impression of Change (CGIC) Scale|CGIC is an assessment that the physician performs to assess the participant's global change in health condition from start of the study on a 7-point scale (1 = extremely improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse 6 = much worse, 7 = extremely worse).|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2684784|NCT01364298|Secondary|Number of Participants With Various Health Conditions Based on Global Impression of Patient Change (GIPC) Scale|GIPC is an assessment that the participant's global change in health condition from start of the study on a 7-point scale (1 = extremely improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse 6 = much worse, 7 = extremely worse).|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'N' (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2684785|NCT01364298|Secondary|Sleep Evaluation: Number of Participants Who Fell Asleep in Pre-specified Time Duration|Sleep evaluation was performed by assessing number of participants who fell asleep in a particular pre-specified range of time duration, that is, 0-15 minutes, 16-30 minutes, 31-45 minutes, 46-60 minutes and greater than 60 minutes at Day 84 (Week 12).|Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug.|||participants|||Number
2684786|NCT01364298|Secondary|Profile of Mood States (POMS) Score|"POMS is a rating scale, which comprises of 65 items that are evaluated in a 0-4 scale, where 0 means not at all and 4 extremely. The scores for the 65 items are added in various combinations to throw six validated factors which are used to calculate total POMS score: (tension-anxiety) + (depression-dejection) + (anger-hostility)+ (fatigue-Inertia) + (confusion-bewilderment) - (vigor-activity). Score range (-40 to 192). Score -40 denotes the best score and score 192 denotes the worst score."|Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug.|||units on a scale||Standard Deviation|Mean
2684787|NCT01364298|Secondary|Change From Baseline in Visual Analogue Scale (VAS) Score at Day 84|VAS is used to rate the pain as per 10 centimeter (cm) line. The pain intensity score ranges from '0=no pain' to '10=worst possible pain'. Change from baseline data has been calculated as value at baseline minus value at Day 84.|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'n' signifies number of participants who were evaluable for specified categories at different time points.|||centimeter||Standard Deviation|Mean
2684803|NCT01363986|Secondary|Brain Progression-Free Survival (B-PFS)|B-PFS was defined as the time from the date of first study drug assumption and the date of documented evidence of brain progression (defined as appearance of new brain metastases or progression of pre-existing lesions) or death for brain progression, whichever came first. Progression in other metastatic sites, deaths not due to brain-progression and withdrawals due to adverse events were to be considered as competing risk.|Baseline, weekly for 3 weeks (pre-WBRT phase), Cycles 1 through 15 (treatment phase Weeks 1 through 15), and 4 weeks after Cycle 15 (Week 15) or the last dose of study treatment|Due to the premature interruption of the study and the small number of enrolled participants (3 nerolled), all participant data were listed only, without any descriptive statistics or data analysis. The endpoint of B-PFS was thus not analyzed.||||||
2701459|NCT01234649|Secondary|Absolute Body Weight|Body weight in LIRA-MET group compared with PL-MET group|84 weeks of treatment||||kilograms||Standard Deviation|Mean
2684788|NCT01364298|Secondary|Change From Baseline in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score at Day 84|The LANSS scale score is 7-item pain scale that consists of grouped sensory description and sensory examination with simple scoring system. Evaluations in two main areas: pain and sensorial exploration. The ﬁrst 5 questions asks for presence of unpleasant skin sensations (pricking, tingling, pins and needles), appearance of skin (mottled, red, or pink), increased sensitivity of skin to touch, sudden bursts of electric shock sensations, and hot or burning skin sensations. Last 2 questions involve sensory testing for the presence of allodynia and altered pinprick threshold. Different numbers of points, relative to their signiﬁcance to neuropathic pain, are given to positive answers for maximum of 24 points. A score less than 12 makes unlikely that participant's symptoms are neuropathic in nature, whereas score more than 12 make neuropathic mechanisms likely to be contributing to participant's pain. Change from baseline data has been calculated as value at baseline minus value at Day 84.|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'n' signifies number of participants who were evaluable for specified categories at different time points.|||units on a scale||Standard Deviation|Mean
2684789|NCT01364298|Primary|Change From Baseline in Average Numeric Pain Intensity Scale (NPIS) Score at Day 84|An average NPIS pain score (daily average records of the past seven days) was evaluated. Numeric pain intensity scale (NPIS) is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours. Change from baseline data has been calculated as value at baseline minus value at Day 84.|Baseline and Day 84 (Week 12)|Per protocol population (PPP) included all the treated participants who showed no major protocol violations and were compliant with study inclusion criteria and with the proper administration of the study drug. 'n' signifies number of participants who were evaluable for specified categories at different time points.|||units on a scale||Standard Deviation|Mean
2684790|NCT01364259|Secondary|Pain Relief Following Radiosurgery|Pain improvement as assessed by the Barrow Neurological Institute (BNI) facial pain score from pre-treatment baseline of BNI 3-5 (3-some pain/controlled on medications, 4-some pain/not controlled on medications, 5-severe pain) to BNI 1-2 (1-no pain/ no medication, 2- occasional pain/no medication)|1 year|8 subjects were enrolled on the Amifostine arm, however, one subject was enrolled but withdrew prior to treatment.|||Participants|||Count of Participants
2684791|NCT01364259|Primary|Facial Numbness Following Radiosurgery|Percent of patients with facial numbness following radiosurgery will be determined at one year follow up.|1 year|One subject randomized to drug arm did not have data.|||Participants|||Count of Participants
2684792|NCT01364233|Primary|Number of Subjects Who Had an Additional Hernia Occur Following Surgery With Condensed Polytetrafluoroethylene (cPTFE, MotifMESH) Mesh|Hernia occurrence at one year after surgery|1 year||||participants|||Number
2684793|NCT01364207|Primary|Change in Intraocular Pressure at 90 Minutes|"At the caffeinated coffee visit: Change in intraocular pressure at 90 minutes = intraocular pressure at 90 minutes post caffeinated coffee ingestion minus intraocular pressure at baseline prior to caffeinated coffee ingestion~At the decaffeinated coffee visit: Change in intraocular pressure at 90 minutes = intraocular pressure at 90 minutes post decaffeinated coffee ingestion minus intraocular pressure at baseline prior to decaffeinated coffee ingestion"|Prior to coffee ingestion (baseline), 90 minutes post coffee ingestion|Only those 106 participants who completed both study visits were included in baseline and final data analyses. The 6 participants who did not complete both study visits were not included in any baseline or final data analyses.|||mm Hg||Standard Deviation|Mean
2684794|NCT01364207|Primary|Change in Intraocular Pressure at 60 Minutes|"At the caffeinated coffee visit: Change in intraocular pressure at 60 minutes = intraocular pressure at 60 minutes post caffeinated coffee ingestion minus intraocular pressure at baseline prior to caffeinated coffee ingestion~At the decaffeinated coffee visit: Change in intraocular pressure at 60 minutes = intraocular pressure at 60 minutes post decaffeinated coffee ingestion minus intraocular pressure at baseline prior to decaffeinated coffee ingestion"|Prior to coffee ingestion (baseline), 60 minutes post coffee ingestion|Only those 106 participants who completed both study visits were included in baseline and final data analyses. The 6 participants who did not complete both study visits were not included in any baseline or final data analyses.|||mm Hg||Standard Deviation|Mean
2684795|NCT01364090|Secondary|Behavioral and Quality of Life|Evaluate changes in illicit drug use, opiate substitution therapy, depression, suicidal ideations and health-related quality of life in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy.|48 weeks|||||||
2684796|NCT01364090|Secondary|Treatment Response (ETR & SVR24)|Evaluate the percentage with undetectable HCV RNA at end of treatment (ETR) and 24 weeks post end of treatment (SVR24) in participants treated with PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non quantifiable HCV RNA or undetectable HCV RNA at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA at week 4 of therapy.|48 weeks|||||||
2684797|NCT01364090|Secondary|Treatment Adherence|Evaluate the adherence (>80 of PEG-IFN, >80% of RBV, >80% of time) to directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.|48 weeks|||||||
2684798|NCT01364090|Primary|Treatment Efficacy|The primary outcome measure is the number of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following directly observed PEG-IFN alfa-2b in combination with self-administered ribavirin for 12 weeks in participants with non-quantifiable (<15 IU/ml detected and <15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy and for 24 weeks in participants with quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy.|36 weeks|ITT|||Participants|||Count of Participants
2684799|NCT01363999|Secondary|Safety: Incidence of Serious Adverse Events||9 weeks||||Events|||Number
2684805|NCT01363986|Secondary|Number of Participants With Brain Objective Response Defined According to RECIST Criteria at the Final Visit|Brain objective response was defined as either a CR or PR), provided that there was no increase in steroid requirements, or worsening of neurological signs and symptoms. CR was defined as the disappearance of all CNS lesions. PR was defined as ≥30% reduction in the volumetric sum of all measurable CNS lesions.|BL and 4 weeks after Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT) or the last dose of study treatment|ITT population; 1 participant was not assessed at the final visit.|||participant|||Number
2684806|NCT01363986|Secondary|Number of Participants With Brain Objective Response According to RECIST Criteria at Cycle 15|Brain objective response was defined as either a CR or PR, provided that there was no increase in steroid requirements or worsening of neurological signs and symptoms. CR was defined as the disappearance of all CNS lesions. PR was defined as ≥30% reduction in the volumetric sum of all measurable CNS lesions.|Baseline and Cycle 15 (Week 15, approximately 13 weeks after completion of WBRT)|ITT population; 2 participants were not assessed at Cycle 15.|||participants|||Number
2684807|NCT01363986|Primary|Number of Participants With Brain Objective Response According to Response Evaluation Criteria In Solid Tumors (RECIST) Criteria at Cycle 7|Brain objective response was defined as either a complete response (CR) or partial response (PR), provided that there was no increase in steroid requirements or worsening of neurological signs and symptoms. CR was defined as the disappearance of all central nervous system (CNS) lesions. PR was defined as a greater than or equal to (≥) 30 percent (%) reduction in the volumetric sum of all measurable CNS lesions.|Baseline and Cycle 7 (Week 7, approximately 5 weeks after completion of whole brain radiotherapy [WBRT])|ITT population; 1 participant was not assessed at Cycle 7.|||participants|||Number
2684808|NCT01363908|Secondary|Change From Baseline in Serum Ferritin|Serum ferritin levels were assessed to determine if a participant was a successful responder and were determined from serum biochemistry analyses conducted at the central laboratories. A negative change from baseline indicates that serum ferritin decreased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.|||ng/mL||Standard Deviation|Mean
2684809|NCT01363908|Secondary|Change From Baseline in Cardiac Iron Load Assessed by T2* MRI|The efficacy of SPD602 was assessed by determining cardiac iron load. Cardiac MRI data were collected by using T2* standard procedures and used to determine iron load. A negative change from baseline indicates that iron load increased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.|||milliseconds||Standard Deviation|Mean
2684810|NCT01363908|Secondary|Change From Baseline in LIC Adjusted by Transfusional Iron Intake And Assessed by R2* MRI|The efficacy of SPD602 was assessed by determining LIC and adjusting for transfusional iron intake. Abdominal MRI data were collected by using R2* standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.|||mg Fe/g*dw||Standard Deviation|Mean
2684811|NCT01363908|Secondary|Change From Baseline in LIC Assessed by R2* MRI|The efficacy of SPD602 was assessed by determining LIC. Abdominal MRI data were collected by using R2* standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.|||mg Fe/g*dw||Standard Deviation|Mean
2684812|NCT01363908|Primary|Change From Baseline in LIC Adjusted by Transfusional Iron Intake And Assessed by FerriScan R2 MRI|The efficacy of SPD602 was assessed by determining LIC and adjusting for transfusional iron intake. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased.|Baseline, 24 weeks, and 48 weeks|The FAS, defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.|||mg Fe/g*dw||Standard Deviation|Mean
2684813|NCT01363908|Primary|Change From Baseline in Liver Iron Concentration (LIC) Assessed by FerriScan R2 Magnetic Resonance Imaging (MRI)|The efficacy of SPD602 was assessed by determining LIC. Abdominal MRI data were collected by using FerriScan R2 standard procedures and used to determine LIC. A negative change from baseline indicates that LIC decreased.|Baseline, 24 weeks, and 48 weeks|The Full Analysis Set (FAS), defined as all participants in the Safety Analysis Set who had at least 1 post-baseline primary efficacy assessment, which was considered as the LICs assessed from FerriScan R2 MRI.|||mg Fe/g*dw||Standard Deviation|Mean
2684814|NCT01363908|Primary|Fraction Of Orally Administered Drug Excreted Unchanged In Urine (fe) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in urine of patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. Children who could cooperate provided urine samples for PK assessment on Day 1 over 3 time intervals: 0-4, 4-8, and 8-24 hours after the last dose (continued into Day 2). Urine concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from urine concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.|||percentage of total dose||Standard Deviation|Mean
2684815|NCT01363908|Primary|Amount Excreted Into Urine (Ue) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in urine of patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. Children who could cooperate provided urine samples for PK assessment on Day 1 over 3 time intervals: 0-4, 4-8, and 8-24 hours after the last dose (continued into Day 2). Urine concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from urine concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.|||mg||Standard Deviation|Mean
2684816|NCT01363908|Primary|Renal Clearance (CLr) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in urine of patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. Children who could cooperate provided urine samples for PK assessment on Day 1 over 3 time intervals: 0-4, 4-8, and 8-24 hours after the last dose (continued into Day 2). Urine concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from urine concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.|||L/h||Standard Deviation|Mean
2684817|NCT01363908|Primary|Terminal Half-life (t1/2) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in plasma of all patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. PK blood samples were collected as follows: Pre-dose on Day 1 (within 60 minutes prior to investigational product administration) and at 0.5, 1, 2, 3, 4, 8 hours (±3 minutes) and 24 hours (±30 minutes) post-dose. Plasma concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from plasma concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.|||hours||Standard Deviation|Mean
2684818|NCT01363908|Primary|Area Under The Plasma Concentration-Time Curve (AUC) From The Time of Dosing to The Last Measurable Concentration (AUClast) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in plasma of all patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. PK blood samples were collected as follows: Pre-dose on Day 1 (within 60 minutes prior to investigational product administration) and at 0.5, 1, 2, 3, 4, 8 hours (±3 minutes) and 24 hours (±30 minutes) post-dose. Plasma concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from plasma concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.|||h*mg/L||Standard Deviation|Mean
2684819|NCT01363908|Primary|Time of Maximum Observed Plasma Concentration Sampled During a Dosing Interval (Tmax) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in plasma of all patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. PK blood samples were collected as follows: Pre-dose on Day 1 (within 60 minutes prior to investigational product administration) and at 0.5, 1, 2, 3, 4, 8 hours (±3 minutes) and 24 hours (±30 minutes) post-dose. Plasma concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from plasma concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The PK set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable.|||hours||Full Range|Median
2684820|NCT01363908|Primary|Maximum Observed Plasma Concentration (Cmax) of SPD602 After a Single Oral Dose|The pharmacokinetic (PK) parameters of SPD602 were measured in plasma of all patients following a single capsule dose of SPD602 at 16 mg/kg at start of treatment on Day 1 and at the clinic visit on Day 2. PK blood samples were collected as follows: Pre-dose on Day 1 (within 60 minutes prior to investigational product administration) and at 0.5, 1, 2, 3, 4, 8 hours (±3 minutes) and 24 hours (±30 minutes) post-dose. Plasma concentrations of SPD602 were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The PK parameters were determined from plasma concentration-time data for SPD602 (total) by non-compartmental analysis.|Day 1 and up to 24 hours post-dose|The Pharmacokinetic (PK) set, defined as all participants in the Safety Analysis Set for whom the primary PK data were considered sufficient and interpretable. The Safety Analysis Set was defined as all participants who had taken at least 1 dose of investigational product. Treatment assignment was based on the treatment actually received.|||ng/mL||Standard Deviation|Mean
2684821|NCT01363843|Secondary|Evaluate the Toxicity of Study Therapy|"Evaluate the toxicity of induction FOLFOX and subsequent infusional 5-FU or capecitabine/radiation. Results show number of patients who experienced a SAE. This does not mean all SAEs were deemed related to treatment.~•Secondary efficacy measures include the clinical response rate, as measured endorectal ultrasound or pelvic MRI, and incidence and severity of toxicities seen during the various phases of study treatment, including treatment delays, bleeding and post-op complications. Each visit will have a toxicity assessment completed"|approx 1 year||||Participants|||Count of Participants
2684822|NCT01363843|Primary|Incidence of Complete Resection|The primary objective of this study is to determine the incidence of pCRs and complete (R0) resections at surgery after induction chemotherapy with 8 cycles of modified FOLFOX6 followed by standard chemoradiation with IMRT with concurrent infusional 5-FU or capecitabine|approx 6 months||||participants|||Number
2684823|NCT01363765|Secondary|NRR of Negative-laboratory TB (Cluster-averaged).|"The notification rate (NR, i.e., number of notifications/100,000 population/year) ratio (NRR) is defined as the NR in the intervention period/NR in the observation period, and is presented in the statistical analysis section.~Numbers are driven from linkage between lab (all tests done) and notification databases; denominators are population taking into account growth of the population during the study period, adjusted for variations in monthly number of opening days (by weighing the number of person-months for the proportion of suspects with samples examined each month out of the total number examined by the laboratory during the whole study period), stratified by sex and age group.~Routine practices were not changed; patients with a high suspicion of TB were, as prior to the study, notified regardless of a confirmatory test."|October 2012 (up to 2 years)||||notifications/100,000 persons/year||95% Confidence Interval|Number
2684905|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: t1/2 (Cohort 1)|t1/2 was analyzed for Cohort 1 (treatment-naive) and was defined as the estimate of the terminal elimination half-life of the drug.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)|||hours|||Number
2684824|NCT01363765|Secondary|NRR of Non-laboratory Tested TB (Cluster-averaged).|"The notification rate (NR, i.e., number of notifications/100,000 population/year) ratio (NRR) is defined as the NR in the intervention period/NR in the observation period, and is presented in the statistical analysis section.~Numbers are participants in the notification database who were not in the lab (all tests done) database; denominators are population taking into account growth of the population during the study period, adjusted for variations in monthly number of opening days (by weighing the number of person-months for the proportion of suspects with samples examined each month out of the total number examined by the laboratory during the whole study period), stratified by sex and age group.~Routine practices were not changed; patients with a high suspicion of TB were, as prior to the study, notified regardless of a confirmatory test."|October 2012 (up to 2 years)|The result is the notification rate ratio|||notifications/100,000 persons/year||95% Confidence Interval|Number
2684825|NCT01363765|Primary|Costs Per Detected Case|Costs per detected case were analyzed using a decision tree model from the national health system perspective. Incremental cost-effectiveness ratio (ICER) was calculated as (costs with Xpert - costs with smears)/(cases detected with Xpert - cases detected with smears). Negative ICERs mean cost saving.|October 2012 (up to 2 years)||||American dollars|||Number
2684826|NCT01363765|Primary|Notification Rate Ratio|Proportion of additional bacteriologically confirmed notified TB cases during intervention period compared to the observation period Patients notified who had a positive test result. The notification rate (NR, i.e., number of notifications/100,000 population/year) ratio (NRR) is defined as the NR in the intervention period/NR in the observation period, and is presented in the statistical analysis section.|October 2012 (up to 2 years)|Only patients found both in laboratory and in the notification databases were included since this is an outcome based on notification rates. Population growth during time was estimated. NR per 100,000 population|||notifications/100,000 persons/year||95% Confidence Interval|Number
2684827|NCT01363713|Other Pre-specified|Change in Bulbar Conjunctiva Hyperemia Score by Visit|"Change from baseline of bulbar conjunctiva hyperemia score. Bulbar conjunctiva hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe).~The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined."|From baseline to 8-week||||score||Standard Error|Mean
2684828|NCT01363713|Other Pre-specified|Change in Palpebral Hyperemia Score by Visit|"Change from baseline of palpebral hyperemia score. Palpebral hyperemia was assessed by the investigator and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe).~The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined."|From baseline to 8-week||||score||Standard Error|Mean
2684829|NCT01363713|Primary|Change in Ocular Itching Score by Visit|"Change from baseline in the average of Ocular itching score over the past 3 days. Ocular itching was assessed by the subject and graded on a 5 points scale of 0-4 (0=no itching, 4=incapacitating itch).~The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined."|From baseline to 8-week||||score||Standard Error|Mean
2684830|NCT01363700|Secondary|Mean Hyperemia Score Compared to Olopatadine Period2|"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores.~The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge ."|Visit 7 (5, 10, and 20 minutes post-CAC)||||score||Standard Error|Mean
2684831|NCT01363700|Secondary|Mean Ocular Itching Score Compared to Olopatadine Period2|"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch.~The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge ."|Visit 7 (3, 5, and 10 minutes post-CAC)||||score||Standard Error|Mean
2684832|NCT01363700|Primary|Mean Hyperemia Score Compared to Placebo Period1|"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean palpebral and bulbar conjunctiva hyperemia was assessed by the investigator at 5, 10, and 20 min post challenge and graded on a 4 points scale of 0-3 (0=none and 3= extremely severe). Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctiva scores. Count unit was defined each eye.~The endpoint used the average score of three time points (5, 10, and 20 minutes) after allergen challenge ."|Visit 5 (5, 10, and 20 minutes post-CAC)||||score||Standard Error|Mean
2684833|NCT01363700|Primary|Mean Ocular Itching Score Compared to Placebo Period1|"A conjunctivitis allergic challenge (CAC) was performed 4 hours after drop instillation. Mean ocular itching score was assessed by the subject at 3, 5, and 10 min post challenge and graded on a 5 points scale of 0-4 where 0=no itching and 4=incapacitating itch. Count unit was defined each eye.~The endpoint used the average score of three time points (3, 5, and 10 minutes) after allergen challenge ."|Visit 5 (3, 5, and 10 minutes post-CAC)||||score||Standard Error|Mean
2684834|NCT01363661|Secondary|Frequency of AEs and SAEs in the Two Groups After Twelve Months of Treatment (Month 12).|Sum of the events collected during 12 months.|Month 12|Intention-to-treat population|||Number of events|||Number
2684835|NCT01363661|Secondary|Frequency of Serious Cardiovascular Events (SCEs) in the Two Groups After Twelve Months of Treatment (Month 12).|Sum of the events collected during 12 months.|Month 12|Intention-to-treat population|||Number of events|||Number
2684836|NCT01363661|Secondary|Change Versus Baseline in Some Specific Endothelial Biomarkers After Twelve Months of Treatment (Month 12).||Month 12|Per protocol population|||Relative change versus baseline (%)||Standard Deviation|Mean
2684837|NCT01363661|Secondary|Change Versus Baseline in the Augmentation Index in the Two Groups After Six and Twelve Months of Treatment (Months 6 and 12).|The results are expressed mean relative change (%) between month 6 or month 12, and baseline. A positive result means improvement in the augmentation index between baseline and month 6 or month 12. It could be considered as a surrogate of a decrease of the arterial stiffness. A negative percentage means the inverse. The are no fixed limits to the scale. At month 6,the minimum observed was -139% and the maximum observed was +1600%.At month 12, the minimum observed was -524% and the maximum observed was +1600%.|Month 6 and Month 12|Per protocol population|||Relative change versus baseline (%)||Standard Deviation|Mean
2684838|NCT01363661|Secondary|Change Versus Baseline in the Score of the EndoPAT in the Two Groups After Six Months of Treatment (Month 6).|The results are expressed mean relative change (%) between month 6 and baseline. A positive result means improvement in the score of the EndoPAT between baseline and month 6. It could be considered as a surrogate of a decrease of the endothelial dysfunction. A negative percentage means the inverse. The are no fixed limits to the scale. The minimum observed was -200% and the maximum observed was +6100%.|Month 6|Per protocol population|||Relative change versus baseline (%)||Standard Deviation|Mean
2684839|NCT01363661|Primary|Change Versus Baseline in the Score of the EndoPAT in the Two Groups After One Year of Treatment (Month 12).|The results are expressed mean relative change (%) between month 12 and baseline. A positive result means improvement in the score of the EndoPAT between baseline and month 12. It could be considered as a surrogate of a decrease of the endothelial dysfunction. A negative percentage means the inverse. The are no fixed limits to the scale. The minimum observed was -275% and the maximum observed was +4200%.|12 months|Per protocol population|||Relative change versus baseline (%)||Standard Deviation|Mean
2684840|NCT01363492|Primary|Change From Baseline in Heart Rate Variability Parameter pNN50||Baseline to week 55||||msec||Standard Deviation|Mean
2684841|NCT01363492|Primary|Change From Baseline in Heart Rate Variability Parameter rMSSD||Baseline to week 55||||msec||Standard Deviation|Mean
2684842|NCT01363492|Primary|Change From Baseline in Heart Rate Variability Parameter SDNN||Baseline to week 55||||msec||Standard Deviation|Mean
2684843|NCT01363492|Secondary|Change From Baseline in Urine Gb3||Baseline to week 55||||(nmol/g creatinine)||Standard Deviation|Mean
2684844|NCT01363492|Secondary|Change From Baseline in Plasma Gb3||Baseline to week 55||||(nmol/mL)||Standard Deviation|Mean
2684845|NCT01363492|Secondary|Change From Baseline in MFS||Baseline to week 55||||(%)||Standard Deviation|Mean
2684846|NCT01363492|Secondary|Change From Baseline in LVMI||Baseline to week 55||||(g/m^2.7)||Standard Deviation|Mean
2684847|NCT01363492|Primary|Development of IgG Anti-Agalsidase Alfa Antibody|Reflects development of Anti-Agalsidase antibodies post baseline|Baseline to Week 55||||participants|||Number
2684848|NCT01363492|Primary|Number of Treatment Emergent Adverse Event (TEAE)||Baseline to week 55||||events|||Number
2684849|NCT01363492|Primary|Number of Serious Adverse Event (SAE)||Baseline to week 55||||events|||Number
2684850|NCT01363479|Secondary|Proportion of Patients With no Rescue Medication||0-24 hours|||||||
2684851|NCT01363479|Secondary|Proportion of Patients With no Emesis||0-24 hours|||||||
2684852|NCT01363479|Primary|Proportion of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication||0-24 hours|Full Analysis Set i.e. patients receiving study drugs and chemotherapy|||percentage of responders||95% Confidence Interval|Number
2684853|NCT01363440|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.|Baseline and Week 52||||scores on a scale||Standard Error|Least Squares Mean
2684854|NCT01363440|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.|Baseline and Week 52||||scores on a scale||Standard Error|Least Squares Mean
2684855|NCT01363440|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF||Baseline and Week 52||||microns||Standard Error|Least Squares Mean
2684856|NCT01363440|Secondary|Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF|Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)|Baseline and Week 52||||percentage of participants|||Number
2684857|NCT01363440|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF||Baseline and Week 52||||percentage of participants|||Number
2684858|NCT01363440|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF||Baseline and Week 52|All secondary efficacy endpoints were analyzed using the full analysis set (FAS). The FAS included all 'Participants received Treatment' and had a baseline and at least 1 post-baseline assessment of Best Corrected Visual Acuity (BCVA).|||percentage of participants|||Number
2684859|NCT01363440|Primary|Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)|Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye were included; a higher score represents better functioning.|Baseline and Week 52|The Primary efficacy endpoint was analyzed using the full analysis set (FAS). The FAS included all 'Participants received Treatment' and had a baseline and at least 1 post-baseline assessment of Best Corrected Visual Acuity (BCVA).|||letters correctly read||Standard Error|Least Squares Mean
2684860|NCT01363401|Secondary|Change in SF-36 (The Short Form (36) Health Survey is a 36 Item)|"The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score presents more severe disability. The higher the score presents less disability.~This was measured at Visit 5 and Visit 9. (week 0,16) The first injection was performed at 0 week.~The score variation baseline(Visit 5) and week 16(Visit 9)"|baseline(Visit 5) and week 16(Visit 9)|The SF-36 was assessed except Two participants of no treatment group, because 1) ICU admissions for breathing therapy 2) Patients reject the measurement.|||point||Standard Deviation|Mean
2684861|NCT01363401|Secondary|Change in Forced Vital Capacity (FVC) (Percent of Predicted Normal)|"Secondary efficacy was measured by comparing the rate of decline of mean FVC by treatment group.~FVC which is a clinical scale to observe variation in patient's respiratory competence, was conducted at Visit 1, Visit 5 and Visit 9. (week -12,0,16) The first injection was performed at 0 week. FVC variation baseline(Visit 5) and week 16(Visit 9)"|baseline(Visit 5) and week 16(Visit 9)|"One of the test group, FVC was assessed except because received tracheostomy during the clinical trial.~FVC was assessed except Two participants of no treatment group because 1) ICU admissions for breathing therapy 2) Patients reject the measurement"|||percent of prediceted||Standard Deviation|Mean
2684862|NCT01363401|Secondary|Change in Appel Scale|"To evaluate the disease change, Appel scale will be assessed. Appel scale is a test tool, which is devised to evaluate the functional condition and variation of ALS(Lou Gehrig's disease) patients (rating 6 to between 30 and 36 points for each of 5 functional conditions, 30-164 total).~The higher the total score presents more severe disability. This was done at Visit 1, Visit 5 and Visit 9 (week -12,0,16). The first injection was performed at 0 week(Visit 5) Appel scale total score variation baseline(Visit 5) and week 16(Visit 9)"|baseline(Visit 5) and week 16(Visit 9)|Apple scale was assessed except Two participants of No treatment group, because 1) ICU admissions for breathing therapy 2) Patients reject the measurement.|||point||Standard Deviation|Mean
2684863|NCT01363401|Primary|The Difference in the Changes of Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R) Between Treatment Groups and Control Groups.|ALSFRS-R is ordinal rating scale questionnaire (rating 0-4 for each question, 4 is most functional, 0-48 total) of 12 functional activities. The most functional total score is 48. ALSFRS-R was evaluated at baseline and week 28.(The first injection was performed at 0 week) ALSFRS-R total score variation baseline(Visit 5) and week 16(Visit 9)|baseline(Visit 5) and week 16(Visit 9)|The ALSFRS-R score was assessed by all the subjects in Phase 1/2 clinical trials.|||score on a scale||Standard Deviation|Mean
2684864|NCT01363349|Secondary|Long Term Schizophrenia Treatment|Evaluation of the antipsychotic efficacy of BL-1020 compared to risperidone after 6, 12 and 24 weeks of treatment|Baseline and 6, 12 and 24 weeks of treatment|||||||
2684865|NCT01363349|Secondary|Long Term Cognition|Evaluation of the cognitive benefits of treatment with BL-1020 compared to risperidone after 12 and 24 weeks of treatment|12 and 24 weeks of treatment|||||||
2684866|NCT01363349|Primary|Cognition|To evaluate the cognitive benefits of treatment with CYP-1020 (formerly known as BL-1020) compared to risperidone after 6 weeks of treatment in patients experiencing acute exacerbation of schizophrenia. Assessed by calculating difference between CYP-1020 and Risperidone on mean change from baseline to Week 6 endpoint on MATRICS Consensus Cognition Battery (MCCB) normative composite score. MCCB is a neuropsychological test battery that comprises 10 measures of 7 different cognitive areas including speed of processing, verbal learning, memory-verbal and non verbal reasoning and problem solving, visual learning, social cognition, attention/vigilance.The study was terminated after the interim analysis. MCBB total score ranges from -50 to 150. Change from Baseline by Visit (LOCF)Higher score means better cognitive functioning.|Baseline and 6 weeks|Analysis for MCCB Score ITT population.|||Scores on a scale||Standard Deviation|Mean
2684867|NCT01363297|Secondary|Messenger Ribonucleic Acid (mRNA) Gene Expression|Optional blood samples for pharmacogenomic parameters were collected during Cycle 1 prior to the start of the inotuzumab ozogamicin infusion (0 hours) and 1 hour post-dose (original Final Protocol and Protocol Amendments 1 and 2) or 3 hours post-dose (Protocol Amendments 3 and 4) on Day 1 and Day 15 from those participants who provided consent. Gene expression analysis of samples collected pre- and post-dosing was performed using 96-gene TaqMan® low density array cards to examine the concordance between clinical outcome and expression of genes such as those involved in DNA damage response, apoptosis, B-cell antigen expression, glutathione metabolism, drug transport and the phosphoinositide 3-kinase/mammalian target of rapamycin pathway. Expression for each gene was reported as a normalized value, 2^-change in (∆) threshold cycle (Ct), where ∆Ct is Ct^target gene minus Ct^reference genes, averaged.|Predose and postdose on Days 1 and 15 of Cycle 1|Pharmacogenomics population - included all enrolled participants who received at least 1 dose of any study drug, and had at least 1 biomarker parameter from the corresponding assay sample with both a baseline and post-treatment assessment.|||Fold expression||Full Range|Median
2684868|NCT01363297|Secondary|Percentage of CD22+ Leukemic Blasts in Abnormal B Cells in Bone Marrow by Visit|CD22+ leukemic blasts assessed in abnormal B cells from bone marrow (data from central laboratories only).|Pre-dose on Days 1 and 15 of Cycles 1 and 2, and Day 1 of Cycle 4|Safety analysis set|||Percentage of CD22+||Full Range|Median
2684869|NCT01363297|Secondary|Percentage of Cluster of Differentiation-22 Positive (CD22+) Leukemic Blasts in Abnormal B Cells in Blood by Visit|CD22+ leukemic blasts assessed in abnormal B cells from blood (data from central laboratories only).|Pre-dose on Days 1 and 15 of Cycles 1 and 2, and Day 1 of Cycle 4|Safety analysis set|||Percentage of CD22+||Full Range|Median
2684870|NCT01363297|Secondary|Duration of Follow-Up|Duration of follow-up was defined as the time from the date of first dose of study drug to the date of last contact for participants known to be alive.|From first dose up to approximately 2 years|Participants who were alive|||Months||95% Confidence Interval|Median
2684871|NCT01363297|Secondary|Time to MRD Negativity for Participants Who Achieved CR or CRi|Time to MRD negativity was defined as the time from the date of first dose of study drug to the date of first documentation of MRD negativity.|Screening, Day 21 of Cycles 1 to 6 and up to 4 to 6 weeks after the last dose (up to 34 weeks)|All participants who achieved CR/CRi and MRD negativity.|||Days||Full Range|Median
2684872|NCT01363297|Secondary|Time to Response for Participants Who Achieved CR/CRi or PR|Time to response was defined as the time from the date of first dose of study drug to the date of first documentation of hematologic response (CR, CRi, or PR).|Up to approximately 2 years from first dose|All participants who achieved CR, CRi or PR.|||Days||Full Range|Median
2684873|NCT01363297|Secondary|Time to Remission for Participants Who Achieved CR or CRi|Time to remission was defined as the time from the date of first dose of study drug to the date of first documentation of hematologic remission (CR or CRi) in participants achieving remission during study therapy.|Up to approximately 2 years from first dose|All participants who achieved CR or CRi|||Days||Full Range|Median
2684874|NCT01363297|Secondary|Overall Survival (OS)|OS was defined as the time from Cycle 1 Day 1 to date of death due to any cause. If death was not documented, censoring occurred at the date at which the participant was last known to be alive.|Up to approximately 2 years from first dose|Safety analysis set|||Months||95% Confidence Interval|Median
2684875|NCT01363297|Secondary|Duration of Response (DoR) for Participants Who Achieved CR/CRi or PR|DoR was defined for participants who respond as the time from the date of first documentation of Hematologic Response (CR, CRi, or PR) to the date of the first documentation of DoR event (earliest date of PD, treatment discontinuation due to global deterioration of health status, first induction therapy or transplant after PR, relapse after CR or CRi or death due to any cause). Participants last known to be 1) alive and 2) without a DoR event, were censored at the date of the last disease assessment that verified lack of event.|Up to approximately 2 years from first dose|All participants who achieved CR, CRi or PR.|||Weeks||95% Confidence Interval|Median
2684876|NCT01363297|Secondary|Duration of Remission (DoR1) for Participants Who Achieved CR or CRi|DoR1 was defined for participants who responded as the time from the date of first documentation of Complete Hematologic Response (CR or CRi) to the date of the first documentation of relapse after CR or CRi, treatment discontinuation due to global deterioration of health status) or to death due to any cause. Participants last known to be 1) alive and 2) without a DoR1 event, were censored at the date of the last disease assessment that verified lack of event.|Up to approximately 2 years from first dose|All participants who achieved CR or CRi|||Months||95% Confidence Interval|Median
2684877|NCT01363297|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from Cycle 1 Day 1 to first documentation of PFS event (earliest date of objective progression [PD], treatment discontinuation due to global deterioration of health status, subsequent induction or transplant after best response of PR or resistant disease, relapse after CR or CRi, or death due to any cause). Participants last known to be 1) alive and 2) without a PFS event, were censored at the date of the last disease assessment that verified lack of event.|Up to approximately 2 years from first dose|Safety analysis set|||Months||95% Confidence Interval|Median
2684878|NCT01363297|Secondary|Percentage of Participants Who Had a Post-Treatment Stem-Cell Transplant (SCT)|Post-treatment SCT rate was defined as the percentage of participants who underwent SCT following treatment with inotuzumab ozogamicin.|Up to approximately 2 years from first dose|Safety analysis set|||Percentage of Particicpants|||Number
2684879|NCT01363297|Secondary|Percentage of Participants With CR or CRi by Cytogenetic Category|CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL.|From screening to progressive disease or another induction therapy started, up to approximately 2 years|Safety analysis set (n refers to number of participants evaluated)|||Percentage of Participants|||Number
2684880|NCT01363297|Secondary|Number of Participants With Minimal Residual Disease (MRD) Negativity in Participants Achieving CR and CRi|MRD negativity was defined as <0.01% mononuclear cells.|From screening to progressive disease or another induction therapy started, up to approximately 2 years|Number of participants who achieved CR and CRi|||Participants|||Number
2684881|NCT01363297|Secondary|Percentage of Participants With CR, CRi or PR in Phase 2|CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL. PR was defined as an improved or no worsening of acute lymphocytic leukemia as indicated by no peripheral blood blasts, and either or both of the following: at least a 50% decrease in the marrow blast percentage, compared to the pre-treatment value, and marrow blast percentage ≥5% and ≤25% and/or C2 extramedullary disease status.|From screening to progressive disease or another induction therapy started, up to approximately 2 years|Safety analysis set|||Percentage of Partcicipants||95% Confidence Interval|Number
2684882|NCT01363297|Primary|Percentage of Participants With CR, CRi or PR During the Phase 1 Expansion Phase|CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL. PR was defined as an improved or no worsening of acute lymphocytic leukemia as indicated by no peripheral blood blasts, and either or both of the following: at least a 50% decrease in the marrow blast percentage, compared to the pre-treatment value, and marrow blast percentage ≥5% and ≤25% and/or C2 extramedullary disease status.|From screening to progressive disease or another induction therapy started, up to approximately 2 years|Safety analysis set|||Percentage of Partcicipants||95% Confidence Interval|Number
2684883|NCT01363297|Primary|Percentage of Participants With CR or CRi During Phase 2|CR was defined as a disappearance of leukemia as indicated by <5% marrow blasts and the absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was defined as CR except with ANC <1000/µL and/or platelets <100,000/µL.|From screening to progressive disease or another induction therapy started, up to approximately 2 years|Safety analysis set|||Percentage of Partcicipants||90% Confidence Interval|Number
2684884|NCT01363297|Primary|Percentage of Participants With Preliminary Satisfactory Response (Complete Response [CR], CR With Incomplete Count Recovery [CRi], Partial Response [PR], or Resistant Disease [RD]) Indicating Disease Stability After First Dose During Phase 1 Dose-Finding|CR was the disappearance of leukemia indicated by <5% marrow blasts and absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by ANC ≥1000/µL and platelets ≥100,000/µL. C1 extramedullary disease status was required. CRi was as for CR except with ANC <1000/µL and/or platelets <100,000/µL. PR was an improved or no worsening of acute lymphocytic leukemia indicated by no peripheral blood blasts, and/or at least a 50% decrease in the marrow blast percentage, compared to pre-treatment value, and marrow blast percentage ≥5% and less than or equal to (≤)25% and/or C2 extramedullary disease status. RD occurred if a participant survived ≥7 days following completion of initial treatment course and had persistent leukemia in the most recent peripheral blood smear or bone marrow and/or persistent disease involvement at any extramedullary site after completion of therapy.|From screening to progressive disease or another induction therapy started, up to approximately 2 years|Safety analysis set|||Percentage of Participants|||Number
2685683|NCT01357720|Primary|Seroprotection Rate: Anti-diphtheria Toxoid Antibodies|Percentage of subjects with antibody levels against diphtheria toxoid ≥0.1 IU/mL (i.e. seroprotection rate)|1 month after the third vaccination|Available observations at Visit 4|||percentage of subjects||95% Confidence Interval|Number
2684885|NCT01363297|Primary|Percentage of Participants Reporting Dose Limiting Toxicities (DLTs) During the Phase 1 Dose-Finding Phase|DLT was any of the following in the first cycle & attributable to inotuzumab ozogamicin: any greater than or equal to (≥) Grade 4 non-hematologic toxicity except nausea/vomiting (if manageable with supportive care), alopecia, & toxicities secondary to neutropenia & sepsis; prolonged myelosuppression (absolute neutrophil count [ANC] less than [<] 500 per microliter [/µL] or platelet count <25,000/µL in bone marrow with <5 percent (%) blasts & no evidence of leukemia more than 45 days beyond the most recent dose of test article); any Grade 3 non-hematologic toxicity (excluding toxicities such as alopecia or those secondary to neutropenia & sepsis) not resolving to ≥ Grade 2 within 7 days of the most recent dose of test article or was clinically significant irrespective of duration; any ≥ Grade 3 elevation of alanine aminotransferase, aspartate aminotransferase or bilirubin lasting ≥7 days; any test article related toxicity resulting in permanent discontinuation of test article.|Cycle 1|Safety analysis set|||Percentage of Participants|||Number
2684886|NCT01363258|Secondary|Oral Health|The oral health will be measured as the total score obtained from the Oral Health Assessment Tool. The OHAT contains 8 categories (e.g., status of gums, dentition, moisture of oral cavity, general cleanliness, etc.). Each category is assigned a value of 0=healthy, 1=problematic, and 2=unhealthy. Scores range from 0 (healthy) to 16 (unhealthy).|Baseline (observation) to follow-up (week 3)||||units on a scale||Standard Error|Mean
2684887|NCT01363258|Primary|Care-Resistant Behavior|"Care-resistant behavior will be measured using the Resistiveness to Care Scale.This instrument is a checklist. The 13 care-resistant behaviors (e.g., turn away, hit/kick, say no, etc.) are listed on the left side of the instrument. There are 3 columns for each behavior (mild, moderate, and severe). When behaviors occur, a tick mark is placed in the appropriate column (mild, moderate, or severe). The final score is obtained by multiplying the sums for mild by 1, the sums for moderate by 2, and the sums for severe behavior by 3. These subtotals are then summed together for a final care-resistant behavior score. One cannot determine the frequency and quality of behaviors from raw scores alone. For example, a score of 12 could mean 12 mild behaviors or 4 severe behaviors. The sums were used as global care-resistant behavior. Higher numbers signify more frequent and intense care-resistant behavior. Minimum value was 0, max value was 25."|Baseline (observation) to follow-up (week 3)|One-hundred nine NH residents were enrolled; 101 were randomized, 100 contributed data for analyses, and 91 completed the 3-week intervention period.|||units on a scale||Standard Error|Mean
2684888|NCT01363076|Primary|MRT (Mean Residence Time)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose||||hr||Standard Deviation|Mean
2684889|NCT01363076|Primary|t1/2 (the Terminal Half-life, Where Possible)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose||||hr||Standard Deviation|Mean
2684890|NCT01363076|Primary|AUC 0-24 (the AUC From Time Zero to 24 Hours Post-dose|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose||||ng•h/mL||Standard Deviation|Mean
2684891|NCT01363076|Primary|AUCinf (the AUC Time From Zero to Infinity, Where Possible)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Pro. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac. AUCinf calculated as: AUCinf = AUC(0-24) + (concentration at 24 hr/elimination constant).|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose||||ng•h/mL||Standard Deviation|Mean
2684892|NCT01363076|Primary|AUClast (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint Post-dose)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose||||ng•h/mL||Standard Deviation|Mean
2684893|NCT01363076|Primary|Tmax (The Time to Maximum Observed Plasma Concentration; ie. The Time at Which Cmax Occured)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Pro. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac. Individual plasma ketorolac concentrations were summarized by dose level for the PK population at each sampling time using n, arithmetic mean, SD, CV(%), geometric mean, 95% confidence intervals (CI) for the arithmetic mean, median, minimum, and maximum.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose||||hr||Full Range|Median
2684906|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Tmax (Cohort 2)|Tmax was analyzed for Cohort 2 (treatment-experienced) and was defined as the time of Cmax.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.|||hours||Inter-Quartile Range|Median
2684894|NCT01363076|Primary|Cmax (the Maximum Observed Plasma Concentration)|Pharmacokinetic analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times for ketorolac assay were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each dose level, together with the individual plasma concentrations of ketorolac.|All PK parameters were assessed using blood samples collected 15 minutes prior to the dose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, and 24 hours after the dose||||ng/mL||Standard Deviation|Mean
2684895|NCT01363050|Primary|MRT (the Mean Residence Time|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.|||hours||Standard Deviation|Mean
2684896|NCT01363050|Primary|AUCτ (the Area Under the Plasma Concentration-time Curve Over the Dosing Interval at Steady-state)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.|||ng*hours/mL||Standard Deviation|Mean
2684897|NCT01363050|Primary|Tmin,ss (the Time to Minimum Concentration at Steady State)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.|||hours||Full Range|Median
2684898|NCT01363050|Primary|Cmin,ss (the Minimum Observed Plasma Concentration at Steady State)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.|||ng/mL||Standard Deviation|Mean
2684899|NCT01363050|Primary|Tmax,ss (the Time to Maximum Concentration at Steady State)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.|||hours||Full Range|Median
2684900|NCT01363050|Primary|Cmax,ss (the Maximum Observed Plasma Concentration at Steady State)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 3 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.|||ng/mL||Standard Deviation|Mean
2684901|NCT01363050|Primary|AUC 0-8h (the Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.|||ng*hours/mL||Standard Deviation|Mean
2684902|NCT01363050|Primary|Tmax (the Time to Maximum Concentration)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.|||hours||Full Range|Median
2684903|NCT01363050|Primary|Cmax (the Maximum Observed Plasma Concentration)|PK analysis by standard model independent methods was performed by a pharmacokineticist using WinNonlin Professional. Actual blood sampling times were converted to a time from dosing (elapsed time). Elapsed times were listed by subject for each treatment, together with the individual plasma concentrations of ketorolac.|Blood samples for determination of plasma concentration of ketorolac were taken immediately prior to each dose and every hour for 8 hours post-dose on Day 1 (morning doses)|Two subjects were considered pharmacokinetic outliers and were excluded from the PK population.|||ng/mL||Standard Deviation|Mean
2684904|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: t1/2 (Cohort 2)|t1/2 was analyzed for Cohort 2 (treatment-experienced) and was defined as the estimate of the terminal elimination half-life of the drug.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.|||hours||Inter-Quartile Range|Median
2684907|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Tmax (Cohort 1)|Tmax was analyzed for Cohort 1 (treatment-naive) and was defined as the time of Cmax.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)|||hours|||Number
2684908|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Ctau (Cohort 2)|Ctau was analyzed for Cohort 2 (treatment-experienced) and was defined as the observed drug concentration at the end of the dosing interval.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.|||ng/mL||Standard Deviation|Mean
2684909|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Ctau (Cohort 1)|Ctau was analyzed for Cohort 1 (treatment-naive) and was defined as the observed drug concentration at the end of the dosing interval.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)|||ng/mL|||Number
2684910|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Cmax (Cohort 2)|Cmax was analyzed for Cohort 2 (treatment-experienced) and was defined as the maximum observed concentration of drug in plasma.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.|||ng/mL||Standard Deviation|Mean
2684911|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: Cmax (Cohort 1)|Cmax was analyzed for Cohort 1 (treatment-naive) and was defined as the maximum observed concentration of drug in plasma.|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)|||ng/mL|||Number
2684912|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: AUCtau (Cohort 2)|AUCtau was analyzed for Cohort 2 (treatment-experienced) and was defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|Participants in the PK/PD Substudy Analysis Set (treatment-experienced only) with available postbaseline data were analyzed.|||h*ng/mL||Standard Deviation|Mean
2684913|NCT01363011|Secondary|Plasma Pharmacokinetics of COBI: AUCtau (Cohort 1)|AUCtau was analyzed for Cohort 1 (treatment-naive) and was defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval).|Blood samples were collected at 0 (predose), 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 8.0, 12.0, and 24.0 hours postdose at baseline and Weeks 2, 4, and 24.|PK/PD Substudy Analysis Set (treatment-naive only)|||h*ng/mL|||Number
2684914|NCT01363011|Secondary|Percentage of Participants Who Experienced Graded Laboratory Abnormalities (Cohort 2)|Laboratory abnormalities were summarized for Cohort 2 (treatment-experienced) and were defined as values that increased at least one toxicity grade from baseline at any time postbaseline up to and including the date of last dose of study drug plus 30 days. A participant was counted once if they had a qualifying event.|Up to 166 weeks plus 30 days|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.|||percentage of participants|||Number
2684915|NCT01363011|Secondary|Percentage of Participants Who Experienced Graded Laboratory Abnormalities (Cohort 1)|Laboratory abnormalities were summarized for Cohort 1 (treatment-naive) and were defined as values that increased at least one toxicity grade from baseline at any time postbaseline up to and including the date of last dose of study drug plus 30 days. A participant was counted once if they had a qualifying event.|Up to 147 weeks plus 30 days|Safety Analysis Set (treatment-naive only)|||percentage of participants|||Number
2684916|NCT01363011|Secondary|Percentage of Participants Who Experienced Adverse Events (Cohort 2)|Adverse events (AEs) occurring from baseline up to 30 days following the last dose of study drug were summarized for Cohort 2 (treatment-experienced). A participant was counted once if they had a qualifying event.|Up to 166 weeks plus 30 days|Safety Analysis Set (treatment-experienced only)|||percentage of participants|||Number
2684917|NCT01363011|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (Cohort 2)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed in Cohort 2 (treatment-experienced) using the FDA snapshot analysis algorithm.|Week 24|Full Analysis Set (treatment-experienced only): participants in the treatment-experienced group who were randomized and received at least one dose of study drug|||percentage of participants|||Number
2684918|NCT01363011|Primary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (Cohort 1)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed in Cohort 1 (treatment-naive) using the FDA snapshot analysis algorithm.|Week 24|Full Analysis Set (treatment-naive only): participants in the treatment-naive group who were randomized and received at least one dose of study drug|||percentage of participants|||Number
2684919|NCT01363011|Primary|Change From Baseline in aGFR at Weeks 2, 4, and 24 (Cohort 2)|Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 2 (treatment-experienced). aGFR was calculated using iohexol plasma clearance.|Baseline; Weeks 2, 4, and 24|PK/PD Substudy Analysis Set (treatment-experienced only): participants in the treatment-experienced group who were enrolled and received at least one dose of study drug and who had data for steady-state PK parameters at the relevant time points were analyzed.|||mL/min||Inter-Quartile Range|Median
2684920|NCT01363011|Primary|Change From Baseline in Actual Glomerular Filtration Rate (aGFR) at Weeks 2, 4, and 24 (Cohort 1)|Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 1 (treatment-naive). aGFR was calculated using iohexol plasma clearance.|Baseline; Weeks 2, 4, and 24|Pharmacokinetic/Pharmacodynamic (PK/PD) Substudy Analysis Set (treatment-naive only): participants in the treatment-naive group who were enrolled and received at least one dose of study drug and who had data for steady-state PK parameters at the relevant time points were analyzed.|||mL/min|||Number
2684921|NCT01363011|Primary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 24 (Cohort 2)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
2684922|NCT01363011|Primary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation, Adjusted at Week 24 (Cohort 1)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
2684923|NCT01363011|Secondary|Percentage of Participants Who Experienced Adverse Events (Cohort 1)|Adverse events (AEs) occurring from baseline up to 30 days following the last dose of study drug were summarized for Cohort 1 (treatment-naive). A participant was counted once if they had a qualifying event.|Up to 147 weeks plus 30 days|Safety Analysis Set (treatment-naive only)|||percentage of participants|||Number
2684924|NCT01363011|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 48 and 96 (Cohort 2)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced) using the FDA snapshot analysis algorithm.|Weeks 48 and 96|Treatment-experienced participants in the Full Analysis Set with available data were analyzed.|||percentage of participants|||Number
2684925|NCT01363011|Secondary|Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 48 and 96 (Cohort 1)|The percentage of participants with HIV-1 RNA < 50 copies/mL at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive) using the FDA snapshot analysis algorithm.|Weeks 48 and 96|Treatment-naive participants in the Full Analysis Set with available data was analyzed.|||percentage of participants|||Number
2684926|NCT01363011|Secondary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation (Adjusted) at Weeks 48 and 96 (Cohort 2)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
2684927|NCT01363011|Secondary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation (Adjusted) at Weeks 48 and 96 (Cohort 1)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
2684928|NCT01363011|Primary|Change From Baseline in eGFR-CKD-EPI Formula Based on Cystatin C Equation at Week 24 (Cohort 2)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
2684929|NCT01363011|Primary|Change From Baseline in eGFR Using the Chronic Kidney Disease, Epidemiology Collaboration (CKD-EPI) Formula Based on Cystatin C Equation at Week 24 (Cohort 1)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
2684930|NCT01363011|Primary|Change From Baseline in eGFR-MDRD at Week 24 (Cohort 2)|Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
2684931|NCT01363011|Primary|Change From Baseline in eGFR Using the Modification of Diet in Renal (MDRD) Equation at Week 24 (Cohort 1)|Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area.|Baseline; Week 24|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
2684932|NCT01363011|Secondary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation at Weeks 48 and 96 (Cohort 2)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
2684933|NCT01363011|Secondary|Change From Baseline in eGFR-CKD-EPI Based on Cystatin C Equation at Weeks 48 and 96 (Cohort 1)|Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
2684934|NCT01363011|Secondary|Change From Baseline in eGFR-MDRD at Weeks 48 and 96 (Cohort 2)|Change from baseline in eGFR-MDRD at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-experienced participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
2684935|NCT01363011|Secondary|Change From Baseline in eGFR-MDRD at Weeks 48 and 96 (Cohort 1)|Change from baseline in eGFR-MDRD at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m^2 body surface area. This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.|||mL/min/1.73 m^2||Inter-Quartile Range|Median
2685000|NCT01362608|Secondary|Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment|Kaplan Meier estimate|12 weeks|Full analysis set|||hours||95% Confidence Interval|Median
2684936|NCT01363011|Secondary|Change From Baseline in eGFR-CG at Weeks 48 and 96 (Cohort 2)|Change from baseline in eGFR-CG at Weeks 48 and 96 were analyzed in Cohort 2 (treatment-experienced). This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Week 48|Participants in the Safety Analysis Set (treatment-experienced only) with available data were analyzed.|||mL/min||Inter-Quartile Range|Median
2684937|NCT01363011|Secondary|Change From Baseline in eGFR-CG at Weeks 48 and 96 (Cohort 1)|Change from baseline in eGFR-CG at Weeks 48 and 96 were analyzed in Cohort 1 (treatment-naive). This outcome is to measure the long-term effect of COBI-containing regimens on renal parameters.|Baseline; Weeks 48 and 96|Treatment-naive participants in the Safety Analysis Set with available data were analyzed.|||mL/min||Inter-Quartile Range|Median
2684938|NCT01363011|Primary|Change From Baseline in eGFR-CG at Week 24 (Cohort 2)|Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 2 (treatment-experienced).|Baseline; Week 24|Safety Analysis Set (treatment-experienced only): participants in the treatment-experienced group who were randomized and received at least one dose of study drug|||mL/min||Inter-Quartile Range|Median
2684939|NCT01363011|Primary|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Cockcroft-Gault (CG) Equation at Week 24 (Cohort 1)|Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 1 (treatment-naive).|Baseline; Week 24|Safety Analysis Set (treatment-naive only): participants in the treatment-naive group who were randomized and received at least one dose of study drug|||mL/min||Inter-Quartile Range|Median
2684940|NCT01362959|Post-Hoc|Time in Normal Brain Function D10|Time alive without delirium and without sedation or coma|10 days||||hours||Inter-Quartile Range|Median
2684941|NCT01362959|Post-Hoc|Time in Normal Brain Function D20|Time spent alive without delirium and without sedation or coma|20 days||||hours||Inter-Quartile Range|Median
2684942|NCT01362959|Secondary|90-day Mortality|Mortality at day 90 after enrollment|Day 90 followup||||percentage of patients|||Number
2684943|NCT01362959|Primary|Patient Location Day 30|In the ICU or hospital at day 30|On day 30||||Participants|||Count of Participants
2684944|NCT01362959|Primary|30-day Mortality||30 days||||percentage of patients|||Number
2684945|NCT01362946|Secondary|Overall Treatment Recommendation - Parent|At end end of both treatment blocks, parents selected which treatment they though was best for their child - standard behavioral treatment or modified behavioral treatment|End of all treatment, at week 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One excluded because only completed one block of treatment.|||percentage of participants|||Number
2684946|NCT01362946|Secondary|Overall Treatment Recommendation - Counselor|At end end of both treatment blocks, counselors sorted children into one of four treatment response groups: (1) responded best to standard behavior therapy; (2) responded best to modified behavior therapy; (3) responded well to both treatments; (4) did not respond to either treatment|End of all treatment, at week 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One excluded because only completed one block of treatment.|||percentage of participants|||Number
2684947|NCT01362946|Secondary|Overall Effectiveness|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: Please rate how effective this treatment was in changing your child as compared with other treatment services your child has received. This item was rated using a Likert scale that ranged from 0 (this treatment much less effective) to 4 (this treatment much more effective)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.|||units on a scale||Standard Error|Least Squares Mean
2684948|NCT01362946|Secondary|Overall Satisfaction|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: Please rate your overall satisfaction with this treatment as compared with other treatment services your child has received. This item was rated using a Likert scale that ranged from 0 (much less satisfied with this program) to 4 (much more satisfied with this program)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.|||units on a scale||Standard Error|Least Squares Mean
2684949|NCT01362946|Secondary|Recommend Treatment?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: Would you recommend this treatment to other parents?. This item was rated using a Likert scale that ranged from 0 (no definitely) to 4 (yes definitely)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.|||units on a scale||Standard Error|Least Squares Mean
2684950|NCT01362946|Secondary|Would You Send Your Child to This Treatment Again?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: Would you send your child to this treatment if you could do it over again?. This item was rated using a Likert scale that ranged from 0 (no definitely) to 4 (yes definitely)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.|||units on a scale||Standard Error|Least Squares Mean
2685001|NCT01362608|Secondary|Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment|Physicians will score their response ofrange of motion on a 5-point Likert scale (normal,mildly restricted, moderately restricted, severely restricted and immolbilized).|baseline through week 12|Full Analysis Set|||participants|||Number
2684951|NCT01362946|Secondary|How Much Did Your Child Enjoy the Treatment?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: How much did your child this treatment?. This item was rated using a Likert scale that ranged from 0 (not at all) to 3 (very much)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.|||units on a scale||Standard Error|Least Squares Mean
2684952|NCT01362946|Secondary|How Much Did You (the Parent) Benefit From Treatment?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: How much did you benefit from this treatment?. This item was rated using a Likert scale that ranged from 0 (not at all) to 3 (very much)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.|||units on a scale||Standard Error|Least Squares Mean
2684953|NCT01362946|Secondary|How Much Did Your Child Benefit From Treatment?|"At the end of each treatment block parents rated their overall satisfaction with the treatment provided to their child. This item was phrased as follows: How much did your child benefit from this treatment?. This item was rated using a Likert scale that ranged from 0 (not at all) to 3 (very much)."|End of each treatment, at weeks 4 and 8|Four children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria). One was excluded because parent did not return completed ratings.|||units on a scale||Standard Error|Least Squares Mean
2684954|NCT01362946|Secondary|WPRF Overall Problems - Parent|"At the end of each treatment week parents rated each child's overall problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
2684955|NCT01362946|Secondary|WPRF Overall Problems - Counselor|"At the end of each treatment week counselors rated each child's overall problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
2684956|NCT01362946|Secondary|WPRF Rule Following Problems - Parent|"At the end of each treatment week parents rated each child's rule following problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
2684957|NCT01362946|Secondary|WPRF Rule Following Problems - Counselor|"At the end of each treatment week counselors rated each child's rule following problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
2684958|NCT01362946|Secondary|WPRF Serious Conduct Problems Scale - Parent|"At the end of each treatment week parents rated each child's serious conduct problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
2684959|NCT01362946|Secondary|WPRF Serious Conduct Problems Scale - Counselor|"At the end of each treatment week counselors rated each child's serious conduct problems during the week. Rating were completed on the Weekly Problem Rating Form (Haas et al, 2011) using Likert scales that ranged from 1 (no problem) to 7 (serious problem). Items were averaged to compute a scale score with a theoretical range of 1 to 7, with high scores indicating more serious problems."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
2684960|NCT01362946|Secondary|IOWA Oppositional-defiant Scale - Parent|"At the end of each treatment week parents rated each child's overall oppositional-defiant behavior during the week. Rating were completed using Likert scales that ranged from 0 (not at all) to 3 (very much). Items were summed to compute a scale score with a theoretical range of 0 to 15."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
2684961|NCT01362946|Secondary|IOWA Oppositional-defiant Scale - Counselor|"At the end of each treatment week counselors rated each child's overall oppositional-defiant behavior during the week. Rating were completed using Likert scales that ranged from 0 (not at all) to 3 (very much). Items were summed to compute a scale score with a theoretical range of 0 to 15."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
2684962|NCT01362946|Secondary|IOWA Inattentive/Overactive Scale - Parent|"At the end of each treatment week parents rated each child's overall inattentive-overactive-impulsive behavior during the week. Rating were completed using Likert scales that ranged from 0 (not at all) to 3 (very much). Items were summed to compute a scale score with a theoretical range of 0 to 15."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
2684963|NCT01362946|Primary|Minutes of Physical Management|Counselors recorded the total number of minutes children had to be physically managed due to behavior dangerous to themselves or others. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Minutes of Physical Manage per day||Standard Error|Least Squares Mean
2684964|NCT01362946|Primary|Number of Time Outs|Counselors recorded the total number of Time Outs children served due to intentional aggression, intentional destruction of property, or repeated noncompliance. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Number of Time Outs per day||Standard Error|Least Squares Mean
2684965|NCT01362946|Primary|Minutes in Time Out|Counselors recorded the total number of minutes children were in Time Out due to intentional aggression, intentional destruction of property, or repeated noncompliance. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Minutes in Time Out per day||Standard Error|Least Squares Mean
2684966|NCT01362946|Primary|Positive Peer Behavior|Counselors recorded each instance of positive behavior with peers, defined as helping, sharing and ignoring teasing. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Number of positive peer behave per day||Standard Error|Least Squares Mean
2684967|NCT01362946|Primary|Rule Violations|Counselors recorded each instance of rule violations. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Number of rule violations per day||Standard Error|Least Squares Mean
2684968|NCT01362946|Primary|Noncompliance|Counselors recorded each instance of noncompliance. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Number of noncompliance per day||Standard Error|Least Squares Mean
2684969|NCT01362946|Primary|Interruption|Counselors recorded each instance of interrupting. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Number of interruptions per day||Standard Error|Least Squares Mean
2684970|NCT01362946|Primary|Complaining|Counselors recorded each instance of complaining. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Number of complaints per day||Standard Error|Least Squares Mean
2684971|NCT01362946|Primary|Negative Verbalizations|Counselors recorded each instance of negative verbalizations, defined as verbal abuse to staff, teasing peers, and swearing. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Number of negative verbals per day||Standard Error|Least Squares Mean
2684972|NCT01362946|Secondary|IOWA Inattentive/Overactive Scale - Counselor|"At the end of each treatment week counselors rated each child's overall inattentive-overactive-impulsive behavior during the week. Rating were completed using Likert scales that ranged from 0 (not at all) to 3 (very much). Items were summed to compute a scale score with a theoretical range of 0 to 15."|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||units on a scale||Standard Error|Least Squares Mean
2684973|NCT01362946|Primary|Conduct Problems|Counselors recorded each instance of conduct problems, defined as lying, stealing, intentional destruction of property, and intentional aggression. The average number per day was computed for each week of treatment.|Weekly|Three children excluded from analyses; two excluded because of medication changes during treatment. One excluded because he was mistakenly enrolled (after collecting treatment data we learned that he did not meet all inclusion criteria).|||Number of conduct problems per day||Standard Error|Least Squares Mean
2703646|NCT01217307|Secondary|Glycometabolic State|measured by oral glucose tolerance testing and Glycated Hemoglobin according to current criteria|4 months and long-term follow-up|||||||
2684974|NCT01362907|Secondary|Overall Lens Fit|As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.|||Units on a scale|Participants|Standard Deviation|Mean
2684975|NCT01362907|Primary|Overall Handling|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.|||Units on a scale||Standard Deviation|Mean
2684976|NCT01362907|Primary|Overall Vision Quality|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.|||Units on a scale||Standard Deviation|Mean
2684977|NCT01362907|Primary|Overall Comfort|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.|||Units on a scale||Standard Deviation|Mean
2684978|NCT01362907|Primary|Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)|As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.|1 week of wear, replacing lenses daily|All enrolled and dispensed participants.|||logMAR|Participants|Standard Deviation|Mean
2684979|NCT01362894|Secondary|Ease of Selecting Final Lens Power|As interpreted by the investigator at time of lens fitting and recorded on a questionnaire. Ease of selecting final lens power was rated on a 10-point scale, with 1 being difficult and 10 being easy.|Day 0|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.|||Units on a scale||Standard Deviation|Mean
2684980|NCT01362894|Primary|Overall Satisfaction|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week, replacing lenses daily|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.|||Units on a scale||Standard Deviation|Mean
2684981|NCT01362894|Primary|Overall Handling|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was rated on a 10-point scale, with 1 being difficult and 10 being easy.|1 week, replacing lenses daily|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.|||Units on a scale||Standard Deviation|Mean
2684982|NCT01362894|Primary|Overall Comfort|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week, replacing lenses daily|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.|||Units on a scale||Standard Deviation|Mean
2684983|NCT01362894|Primary|Overall Vision|As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision was rated on a 10-point scale, with 1 being poor and 10 being excellent.|1 week, replacing lenses daily|The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.|||Units on a scale||Standard Deviation|Mean
2684984|NCT01362790|Other Pre-specified|Count of Participants SS1P Cycles Received Following Onstudy|Here are the number of participants who had SS1P cycles during cycle 1-6.|Cycles 1-6, up to 180 days|No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.|||Participants|||Count of Participants
2684985|NCT01362790|Secondary|Duration of Response|DOR is assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria and is measured from the time measurement criteria is met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to<10mm. partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive disease is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum on study LD (this includes the baseline sum if that is the smallest on study).|up to 2.5 years|In months; the only 3 responders were in group one, thus arm/groups 2-7 are not shown here.|||Months||95% Confidence Interval|Median
2685002|NCT01362608|Secondary|Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment|Physicians will score their response of erythema on a 4-point Likert scale (absent, present not assessed and not assessable).|baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose|Full analysis set|||participants|||Number
2685003|NCT01362608|Secondary|Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment|Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).|baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose|Full analysis set|||participants|||Number
2684986|NCT01362790|Secondary|Progression-free Survival|Defined as the time interval from the start of treatment to documented evidence of disease progression. Progressive disease is assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria, and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum on study LD (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression).|36 months|No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.|||Months||95% Confidence Interval|Median
2684987|NCT01362790|Secondary|Overall Survival|The Kaplan-Meier was used to determine the probability of overall survival from on-study date until death or last follow-up (calculated from the date of study entry until the date of analysis).|36 months|No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.|||Months||95% Confidence Interval|Median
2684988|NCT01362790|Primary|Recommended Phase 2 Dose (RP2D) in Drug Lot FIL129J01|Should any 2 patients within the first 3 to 6 patients experience treatment limiting toxicity requiring cessation of treatment prior to the conclusion of the first cycle, the maximum tolerated dose will have been exceeded and patients will be enrolled to the next lower dose.|Days 1, 3, and 5 of a 21 day cycle||||mcg/kg/dose|||Number
2684989|NCT01362790|Primary|Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) Who Were Administered SS1P and Pentostatin or Cyclophosphamide|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 64 months and 26 days|No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.|||Participants|||Count of Participants
2684990|NCT01362790|Primary|Count of Participants With SS1P Antibody Formation|Development of antibodies following treatment with SS1P. The goal was to delay development of antibodies to SS1P so a patient could get a second cycle of therapy with SS1P.|On last day of last dosing cycle, end of cycle 1 (day 30)|No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.|||Participants|||Count of Participants
2684991|NCT01362790|Primary|Response Assessment|Response was assessed by the European Organization for Research and Treatment of Cancer (EORTC) modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response (CR) is complete disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease (PD) disease is at least a 20% increase in the sum of the LD of target lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|52 months and 4 days|No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.|||Participants|||Count of Participants
2684992|NCT01362686|Secondary|Healthy Aging Brain Care (HABC)-Monitor|The current HABC-Monitor includes 30 items covering four clinically relevant domains of dementia, ie, cognitive, functional, behavioral, and psychological symptoms, and caregiver quality of life. For brevity and practical use in the clinical setting, each item on the four scales was designed to have the same item response options consisting of four categories that use the frequency of the target problem in the past 2 weeks. The HABC- Monitor took approximately 6 minutes to complete. The scores of the four scales are summed to create the total scores which were used in this analysis.The higher the total score, the higher the level of self reported caregiver burden. The minimum score is 0 and the maximum score is 90.|baseline, 6, 12, and 18 week interviews||||units on a scale||Standard Deviation|Mean
2684993|NCT01362686|Secondary|Neuropsychiatric Inventory (NPI)|The NPI is based on a structured interview administered to an informal caregiver and has been adopted by the Alzheimer's Disease Cooperative Studies Group to obtain information on the presence of psychopathology in behavioral areas including delusions, apathy, hallucinations, disinhibition, agitation, depression, aberrant motor behavior, anxiety, night-time behavior, and euphoria.9 For each of 12 symptoms, if the caregiver reports the presence of psychopathology, a frequency and severity score are multiplied to yield a possible item score range of 0-12, and a possible total score range of 0-144. The NPI can be used to assess changes in the patient's behavior over the past month. The NPI also assesses the level of caregiver distress attributable to each of the 12 patient behaviors, with a possible total caregiver distress score range of 0-60. Higher scores indicate higher severity of psychopathology and caregiver disress. The NPI has excellent reliability and validity.|Baseline, 6, 12, 18 week interviews from enrollment||||units on a scale||Standard Deviation|Mean
2684994|NCT01362686|Primary|Discontinuation Rates|We are not seeking to establish efficacy of these three medications for the indication of Alzheimer's disease. Each of these medications already has FDA-approval for Alzheimer's. The primary outcome measure is the discontinuation rate among the three medications. Based on previous systematic reviews, these rates are reportedly in the range of 30% by 12 weeks compared with placebo. We will determine the approximate date of discontinuation by self-reports from the caregiver through the telephone-based interview at 6, 12, and 18 weeks.|6, 12, and 18 week interviews from enrollment||||participants|||Number
2684995|NCT01362608|Secondary|High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose||72 hours post dose||||mg/L||95% Confidence Interval|Mean
2684996|NCT01362608|Secondary|Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.|Paracetamol / acetaminophen, Prednisolone and Prednisone taken at baseline flare and post baseline flare.|12 weeks|FAS|||mg||Standard Deviation|Mean
2684997|NCT01362608|Secondary|Percent Patients Who Took Rescue Medication||12 weeks|FAS|||percentage|||Number
2684998|NCT01362608|Secondary|Time to First Rescue Medication Intake||12 weeks|FAS|||hours||Standard Deviation|Mean
2684999|NCT01362608|Secondary|Time to Complete Resolution of Pain: Survival Analysis by Treatment|Kaplan Meier estimate|12 weeks|Full analysis set|||hours||95% Confidence Interval|Median
2703647|NCT01217307|Secondary|Diastolic Function|echocardiographic analysis of diastolic function|4 months|||||||
2685004|NCT01362608|Secondary|Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment|Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).|baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose|Full analysis set|||participants|||Number
2685005|NCT01362608|Secondary|Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.|Patients will score their response to pain on a 7-point Likert scale (excellent, good ,acceptable, slight,poor,very poor,not done).|72 hours through week 12|Full Analysis Set|||participants|||Number
2685006|NCT01362608|Secondary|Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment|Patients will score their current pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme).|baseline through week 12|Full Analysis Set|||participants|||Number
2685007|NCT01362608|Secondary|Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment|A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm)|baseline through 12 weeks|Full Analysis set|||unit on a scale||Standard Deviation|Mean
2685008|NCT01362608|Secondary|The Number of Patients With at Least 1 New Gout Flare||12 weeks||||participants|||Number
2685009|NCT01362608|Primary|Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis|Measure canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks|12 weeks|Full Analysis Set|||Participants||95% Confidence Interval|Number
2685010|NCT01362608|Primary|The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)|A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm)|at 72 hours post-dose|Full Analysis set|||units on a scale||Standard Error|Least Squares Mean
2685011|NCT01362530|Secondary|Percentage of Participants With No Vomiting in the Overall Phase of Cycle 1|Overall phase was defined as 0 to 120 hourse after the start of chemotherapy. No vomiting was defined as no emesis or retching or dry heaves in the overall phase of Cycle 1.|0 to 120 hours after initiation of chemotherapy|ITT population: all randomized participants who received study medication. Results for Cycles 2-6 were not included because this outcome measure is for Cycle 1 only.|||Percentage of participants|||Number
2685012|NCT01362530|Secondary|Percentage of Participants With a Complete Response in the Overall Phase of Cycle 1|Overall phase was defined as 0 to 120 hourse after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the overall phase of Cycle 1.|0 to 120 hours after initiation of chemotherapy|ITT population: all randomized participants who received study medication. Results for Cycles 2-6 were not included because this outcome measure is for Cycle 1 only.|||Percentage of participants|||Number
2685013|NCT01362530|Secondary|Percentage of Participants With a Complete Response in the Acute Phase of Cycle 1|Acute phase was defined as 0 to 24 hours after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the acute phase of Cycle 1.|0 to 24 hours after initiation of chemotherapy|ITT population: all randomized participants who received study medication. Results for Cycles 2-6 were not included because this outcome measure is for Cycle 1 only.|||Percentage of participants|||Number
2685014|NCT01362530|Primary|Percentage of Participants With a Complete Response in the Delayed Phase of Cycle 1|Delayed Phase was defined as 25-120 hours after the start of chemotherapy. Complete response was defined as no vomiting or retching and no use of rescue medication in the delayed phase of Cycle 1.|25 to 120 hours after the start of chemotherapy|Intent-to-treat (ITT) population: all randomized participants who received study medication. Results for Cycles 2-6 were not included because this outcome measure is for Cycle 1 only.|||Percentage of participants|||Number
2685015|NCT01362517|Secondary|Safety: Adverse and Serious Adverse Events|Assessment of the proportion of children with adverse events and/or serious adverse events following each Quinvaxem vaccine injection|From Day 1 up to 30 days after the third vaccination||||Number of children with AE per 100 doses|Participants||Number
2685016|NCT01362517|Primary|Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component|Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)|at 14 months (equivalent to 12 months after the first vaccination|Analysis population excludes one subject excluded as a protocol violator and additionally at 14 months one lost to follow up|||percentage of subjects||95% Confidence Interval|Number
2685017|NCT01362517|Primary|Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component|Assessment of the proportion of subjects who have seroconverted to each of the 5 vaccine components (D, T, P, HepB, Hib)|at 5 months (equivalent to 1 month after the third vaccination)|Analysis population excludes one subject excluded as a protocol violator|||percentage of subjects||95% Confidence Interval|Number
2685018|NCT01362491|Secondary|Cumulative Percentage of Participants With Complete Relief|Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief|1, 2, & 3 hours post-dose|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||percentage of participants|||Number
2685019|NCT01362491|Secondary|Cumulative Percentage of Participants With Treatment Failure|Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.|1, 2, 3 hours post-dose|ITT population included all randomized patients who received study medication and provided a baseline assessment.|||percentage of participants|||Number
2685832|NCT01355471|Primary|Composite Success|Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).|Day 29|Intent-to-Treat (ITT) population(i.e. Hours 3,6,9,12)|||participants|||Number
2685021|NCT01362491|Secondary|Cumulative Percentage of Participants With First Perceptible Relief|"Percentage of participants with first perceptible relief evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful."|0.5, 1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||percentage of participants|||Number
2685022|NCT01362491|Secondary|Cumulative Percentage of Participants With Meaningful Relief|"Percentage of participants with meaningful relief evaluated by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated meaningful relief at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered."|0.5, 1, 2, 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||percentage of participants|||Number
2685023|NCT01362491|Secondary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)|SPRID: time-weighted sum of PRID over 2 and 3 hours. SPRID score range was -2(worst) to 14(best) for SPRID 0-2 and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on scale||Standard Deviation|Mean
2685024|NCT01362491|Secondary|Time-weighted Sum of Pain Relief Rating (TOTPAR)|TOTPAR: time-weighted sum of PRR over 2 and 3 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2 and 0 (worst) to 12 (best) for TOTPAR 0-3. PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on scale||Standard Deviation|Mean
2685025|NCT01362491|Secondary|Time-weighted Sum of Pain Intensity Difference (SPID)|SPID: time-weighted sum of PID over 2 and 3 hours. SPID score range was -2(worst) to 6 (best) for SPID 0-2 and -3 (worst) to 9 (best) for SPID 0-3. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best).|0 to 2, 0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on scale||Standard Deviation|Mean
2685026|NCT01362491|Secondary|Sum of Pain Relief Rating and Pain Intensity Difference (PRID)|PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).|1, 2 & 3 hours post-dose|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on scale||Standard Deviation|Mean
2685027|NCT01362491|Secondary|Pain Intensity Difference (PID)|PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best).|1, 2 & 3 hours post-dose|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on scale||Standard Deviation|Mean
2685028|NCT01362491|Secondary|Pain Relief Rating (PRR)|PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.|1, 2 & 3 hours post-dose|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||units on scale||Standard Deviation|Mean
2685029|NCT01362491|Secondary|Time to Confirmed First Perceptible Relief|"Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both first perceptible and meaningful relief by either depressing the second stopwatch or by indicating that his/her first perceptible relief was also meaningful."|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||minutes||95% Confidence Interval|Median
2685030|NCT01362491|Secondary|Time to Onset of Meaningful Relief: Remaining Comparisons|"Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated meaningful relief at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered."|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||minutes||95% Confidence Interval|Median
2685031|NCT01362491|Primary|Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet|"Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated meaningful relief at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered."|0 to 3 hours|ITT population included all randomized participants who received study medication and provided a baseline assessment.|||minutes||95% Confidence Interval|Median
2703720|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|16 weeks|||||||
2685032|NCT01362491|Primary|Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet|SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of pain intensity differences (PID) and pain relief rating(PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).|0-3 Hours|Intent-to-treat (ITT) population included all randomized participants who received study medication and provided a baseline assessment.|||units on scale||Standard Deviation|Mean
2685033|NCT01362439|Secondary|Extrapyramidal Symptoms Scale (ESRS) Subscale Scores and Total Scores|Extra pyramidal symptoms attributed to antipsychotic assessed by ESRS scale. Included 4 subscales; Parkinsonism (Park),dystonia(Dyst),dyskinesia(Dysk),akathisia(Akat),12 items on 4-point scale; (0=absent-3=severe); Park (8 items); Dyst (2 items); Dysk (7 items) all 3 rated on 7-point scale (0=none/normal-6=worst). Additionally, subtotals were calculated; hyperkinesia (item 5, 6 of Park); hypokinesia (item 1-4, 7 of Park); bucco-linguo-masticatory (item 1-3 of Dysk), choreoathetoid movement (item 5, 6 of Dysk). Total score: sum of Park, Dyst & Dysk subscale, ranged from 0 (normal)-102 (severe).|Baseline and Week 13|Safety population included all participants who received atleast one dose of study medication.|||units on a scale||Standard Deviation|Mean
2685034|NCT01362439|Secondary|Daytime Drowsiness Evaluation Scale|This self-administered scale rates quality of sleep and daytime drowsiness. Participants will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).On the daytime drowsiness scale, score 0 corresponds to not at all and score 10 to all the time.|Baseline and Week 13|ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.|||units on a scale||Standard Deviation|Mean
2685035|NCT01362439|Secondary|Quality of Sleep Score|This self-administered scale rates quality of sleep and daytime drowsiness. Participants indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time). On the sleep evaluation scale, score 0 corresponds to very badly and score 10 to very well.|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.|||units on a scale||Standard Deviation|Mean
2685036|NCT01362439|Secondary|Change From Baseline in Personal and Social Performance Scale (PSP) at Week 13|The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post Baseline was used for final evaluation using LOCF method.|||units on a scale||Standard Deviation|Mean
2685037|NCT01362439|Secondary|Clinical Global Impression-Severity Scale (CGI-S)|The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to normal, not at all ill and a rating of 7 is equivalent to among the most extremely ill participants. Higher scores indicate worsening.|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post Baseline was used for final evaluation using LOCF method.|||units on a scale||Full Range|Median
2685038|NCT01362439|Secondary|Change From Baseline in Drug Attitude Inventory (DAI 30) Scale at Week 13|The DAI is a 30-item self-rating inventory that focuses on subjective effects of neuroleptic medications in participants with schizophrenia. There are 15 items that are scored as true and 15 scored as false if the person is fully compliant (positive subjective response). Positive answers score as +1, negative answers score as - 1. Questionnaire allows identifying participants at high risk of low compliance. The total score may vary from -30 to +30 with a high total final score is a positive subjective response (compliant) and a low total score is a negative subjective response (non-compliant).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.|||units on a scale||Standard Deviation|Mean
2685039|NCT01362439|Secondary|Change From Baseline in Subjective Well-being Under Neuroleptic (SWN 20) Scale at Week 13|The SWN 20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood.|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.|||units on a scale||Standard Deviation|Mean
2685065|NCT01362322|Secondary|Number of Seropositive Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations)|A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 5 Enzyme Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).|At Day 0 (PRE) vaccine and at Month 1 (POST)|The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2703721|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|14 weeks|||||||
2685040|NCT01362439|Secondary|Percentage of Participants With Greater Than or Equal to 30 Percent Treatment Response in Total Positive and Negative Syndrome Scale (PANSS) Score|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method. 'N' (number of participants analyzed) signified participants evaluable for this measure.|||percentage of participants|||Number
2685041|NCT01362439|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Subscale Score at Week 13|The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.|||units on a scale||Standard Deviation|Mean
2685042|NCT01362439|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 13|The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.|||units on a scale||Standard Deviation|Mean
2685043|NCT01362439|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 13|The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).|Baseline and Week 13|The ITT included all participants who received at least one dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using LOCF method.|||units on a scale||Standard Deviation|Mean
2685044|NCT01362439|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 13|The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.|Baseline and Week 13|Intent to Treat Population (ITT) included all participants who received at least 1 dose of study medication. For participants leaving study prematurely last available data post-baseline was used for final evaluation using Last observation carried forward (LOCF) method.' N' (number of participants analyzed): participants evaluable for this measure.|||units on a scale||Standard Deviation|Mean
2685045|NCT01362348|Secondary|Summary of Plasma Pazonib Concentration|Throughout the study, 1 to 4 blood samples (2 mL) were collected from each participants for the analysis of plasma pazopanib concentrations between 0.55 to 10.83 hours post-dose on Weeks 2, 3, 4, 6 (unplanned), 8 (unplanned) and 12. The concentrations from the three blood samples per participant were averaged and then the values were averaged through all the participants. Blood samples were collected without restriction for the time interval between blood draw and the last dose of pazopanib eye drops.|Up to Week 12|Pharmacokinetic Population was defined as participants in the ITT Population for whom a pharmacokinetic sample was obtained and analyzed. Only those participants available at the specified time points were analyzed.|||nanograms per milliliter||Standard Deviation|Mean
2685046|NCT01362348|Secondary|Number of Participants With Abnormal Urinalysis Data by Urine Microscopy and Dipstick Analysis|Urinalysis measurements included assessments for red blood cells and white blood cells via microscopic examination while assessments for urine protein by standard dipstick analysis. Data has been presented for the number of participants with abnormal urinalysis results.|Up to Follow-up (Day 102)|Safety Population. Only those participants available at the specified time points were analyzed,|||Participants|||Count of Participants
2685047|NCT01362348|Secondary|Number of Participants With Clinical Chemistry and Hematology Data of Potential Clinical Concern|Clinical chemistry parameters included albumin, alkaline phosphatase, alanine amino transferase, aspartate amino transferase, direct bilirubin, total bilirubin, calcium, chloride, carbon dioxide, creatinine, thyroxine (T3 free), gamma glutamyl transferase, glucose, potassium, sodium, total protein, total T3, urea, uric acid while hematology included basophils, eosinophils, hemoglobin, hematocrit, lymphocytes, mean corpuscle hemoglobin concentration, mean corpuscle hemoglobin, mean corpuscle volume, monocytes, segmented neutrophils, total neutrophils, platelet count, red blood cell count, reticulocytes and white blood cell count. The potential clinical concern ranges were as follows: glucose-low <3 and high >9 millimoles per liter (mmol/L), carbon dioxide-low <18 and high >34 mmol/L, lymphocyte-low <0.8 giga per liter (G/L) and platelet count was <100 and high >550 G/L. Data has been presented for the number of participants with values high and low of potential clinical concern.|Up to Follow-up (Day 102)|Safety population.|||Participants|||Count of Participants
2685048|NCT01362348|Secondary|Number of Participants With Vital Sign Data of Potential Clinical Concern|Vital sign assessments included systolic blood pressure, diastolic blood pressure and heart rate. The potential clinical concern range for systolic blood pressure was <85 and >160 millimeters of mercury, diastolic blood pressure <45 and > 100 millimeters of mercury, heart rate <40 and >110 beats per minute. Data has been presented in a consolidated format for the total number of participants with values of potential clinical concern for systolic blood pressure, diastolic blood pressure and heart rate until Day 102.|Up to Follow-up (Day 102)|Safety Population|||Participants|||Count of Participants
2685833|NCT01355458|Primary|Composite Success|Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).|Day 29|Intent-to-Treat (ITT) population (i.e. Hours 3,6,9,12)|||participants|||Number
2685049|NCT01362348|Secondary|Number of Participants With Values of Potential Clinical Concern for Ocular Assessments on General Ophthalmic Examination|A complete eye examination was performed to include the following: Examination of eyelids and lashes (including meibomian glands), Pupil, motility and confrontation visual field examination, Slit lamp evaluation of anterior ocular structures (including conjunctiva, tear film, cornea with fluorescein staining, anterior chamber, iris, lens, and anterior vitreous), Intraocular pressure (IOP) measurement and Dilated Fundus Examination (Indirect ophthalmoscopy and slit lamp biomicroscopy). Data has been presented in a consolidated format for the total number of participants with values of potential clinical concern for complete ophthalmic examinations until Day 102.|Up to Follow-up (Day 102)|Safety Population.|||Participants|||Count of Participants
2685050|NCT01362348|Secondary|Number of Participants With Ocular Adverse Events (AEs), Non-ocular AEs, Serious Ocular AEs and Serious Non-ocular AEs|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.|Until Follow-up (Day 102)|Safety Population.|||Participants|||Count of Participants
2685051|NCT01362348|Secondary|Number of Participants Who Received Rescue Medication|At any time during the study, including the follow-up period, rescue treatment (standard of care) was given based on the clinical judgment of the investigator. Rescue treatment was to be strongly considered for participants whose center subfield thickness had increased by >50 microns from the lowest value on study or whose BCVA decreased by more than 5 letters compared to baseline and who also had persistent fluid by OCT. Data has been reported for the number of participants with their percentages who required any rescue medication administration until follow-up.|Up to follow-up (Day 102)|Safety Population comprised of any participant who received at least one dose of study medication.|||Participants|||Count of Participants
2685052|NCT01362348|Secondary|Number of Participants With Change in Charactertsics (Atrophy, Pigment, SR Hemorrhage, IR Hemorrhage, SR Fluid and Fibrosis) as Measured by FP|Fundus photography involves capturing of images of the center of the very back inner wall of the eye — the retina, optic nerve, macula and main retinal blood vessels. The parameters assessment were heme SR hemorrhage (absence or presence at the location), heme IR hemorrhage (absence or presence at the location), SR fluid (absence or presence at location), fibrosis (absence or presence at location), atrophy (absence or presence of atrophic changes) and pigment (absence or presence at location). A protocol set of fundus photographs were obtained at Day 29. Images were read by the investigator for eligibility determination, and by a central reading center for determination of PD effect. Data has been presented for number of participants with changes in eye characteristics in the study eye at Day 29.|Day 29|ITT Population. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis.|||Participants|||Count of Participants
2685053|NCT01362348|Secondary|Change From Baseline in the Area of Choroidal Neovascular (CNV) Size and CNV Total Lesion Complex Size as Measured by Fluorescein Angiography (FA) at Day 29|CNV was the measurement of the combined classic and occult neovascular lesion including areas of classic neovascularization, late staining of undetermined origin and fibrovascular PED. CNV total lesion complex size was the measurement of the entire lesion including classic and occult neovascular components as well as contagious blood and/or blocked fluorescence and/or serous PED. FA uses fundus photography (FP) to capture images of injected dye circulating throughout the retinal blood vessels to assess leaking, swelling/circulation problems caused by various eye diseases like diabetic retinopathy and wet macular degeneration. A fluorescein angiogram was obtained at Day 29. Images were evaluated by investigator for eligibility and by a central reading center for determination of PD effect. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Day -3 to -1) and Day 29|ITT Population. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis.|||millimeter square||Standard Deviation|Mean
2685054|NCT01362348|Secondary|Change From Baseline in BCVA Over Time|BCVA was measured in the study eye using the EVA chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the participant. A decrease in the BCVA score indicates a worsening of vision while higher scores indicates improvement of VA. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Week -3 to -1) Up to Follow-up (Day 102)|ITT Population. Only those participants available at the specified time points were analyzed. OC dataset was used for analysis.|||Letters||Standard Deviation|Mean
2685055|NCT01362348|Secondary|Change From Baseline in Intraretinal (IR) or Subretinal (SR) Fluid Thickness, Intraretinal Cysts or Serous Retinal Pigment Epithelial Detachment (PED Thickness) Over Time|OCT was used for the determination of retinal morphology changes in the study eye which included assessments of SR fluid (an exudate between the retina and choroid from various sources including the vitreous cavity, subarachnoid space, or abnormal vessels) and PED (retinal pigment epithelium separates from the underlying Bruch's membrane due to the presence of blood, serous exudate, drusen, or a neovascular membrane). Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Week -3 to -1) Up to Follow-up (Day 102)|ITT Population. Only those participants available at the specified time points were analyzed. OC dataset was used for analysis.|||Microns||Standard Deviation|Mean
2685066|NCT01362322|Secondary|Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens|A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( ≥) 1 international units per milliliter (IU/mL).|At Day 0 (PRE) vaccine and at Month 1 (POST)|The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2685056|NCT01362348|Secondary|Change From Baseline in Central Retinal Lesion Thickness (CRLT) Over Time|CRLT was the manual measurement of the distance between the inner limiting membrane of the retina and the inner border of the choriocapillaris, inclusive of subretinal or sub-retinal pigment epithelium fluid collections and of the thickness of any observable choroidal neovascular membrane or scar tissue, evaluated in the central 1 mm of the Cube scan. OCT assessments were performed using SPECTRALIS spectral domain OCT. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Week -3 to -1) Up to Follow-up (Day 102)|ITT Population. Only those participants available at the specified time points were analyzed. OC dataset was used for analysis.|||Microns||Standard Deviation|Mean
2685057|NCT01362348|Primary|Change From Baseline in Best Correct Visual Acuity (BCVA) as Measured by the Number of Letters Determined by Electronic Early Treatment Diabetic Retinopathy [ETDRS] Study Visual Acuity (EVA) at Day 29|BCVA was measured in the study eye using the EVA chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the participant. A decrease in the BCVA score indicates a worsening of vision while higher scores indicates improvement of VA. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.|Baseline (Day -3 to -1) and Day 29|ITT Population. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis.|||Count of letters||Standard Deviation|Mean
2685058|NCT01362348|Primary|Change From Baseline in Central Retinal Lesion Thickness (CRT) as Measured by Optical Coherence Tomography (OCT) at Day 29|CRT was the distance between the inner limiting membrane of the retina and the inner border of the retinal pigment epithelium/choriocapillaris band, inclusive of sub retinal fluid, measured in the central 1 millimeter (mm) of the Cube scan. OCT assessments were performed using SPECTRALIS spectral domain OCT. Images were evaluated by investigator for safety monitoring, and by a central reading center for eligibility determination and pharmacodynamics (PD) effects. Observed case (OC) data set was used for analysis in this analysis dataset, a missing assessment at any scheduled time point was considered unevaluable, was not imputed and was not included in data analysis. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the baseline value from the individual post-randomization value at Day 29.|Baseline (Week 0) and Day 29|The Intent-to-treat (ITT) Population comprised of any participant who received at least one dose of study medication. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis.|||Microns||Standard Deviation|Mean
2685059|NCT01362322|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (Day 0 - Month 1)|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine.|||Participants|||Count of Participants
2685060|NCT01362322|Secondary|Number of Subjects With Any Solicited General Symptoms|Assessed solicited general symptoms were fatigue, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms. Gastrointestinal symptoms included Nausea, Vomiting, Diarrhea and or Abdominal pain. Any = occurrence of the symptom regardless of intensity grade.|Within 4 days (Days 0-3) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine and with the symptom sheet filled-in.|||Participants|||Count of Participants
2685061|NCT01362322|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Days 0-30) post|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine.|||Participants|||Count of Participants
2685062|NCT01362322|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.|Within 4 days (Days 0-3) post vaccination period|The analysis was performed on the Total Vaccinated cohort, which included all subjects with documented administration of the study vaccine and with the symptom sheet filled-in.|||Participants|||Count of Participants
2685063|NCT01362322|Secondary|Number of Subjects With a Booster Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN) Antigens.|Booster response to the PT, FHA and PRN antigens, was defined as: for initially seronegative subjects: antibody concentrations at least 4 times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL); for initially seropositive subjects with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL: an increase in antibody concentrations of at least 4 times the pre-vaccination concentration; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least 2 times the pre-vaccination concentration.|At Month 1|The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2685064|NCT01362322|Secondary|Number of Subjects With Booster Response to Diphtheria (D) and Tetanus (T) Antibodies|Booster response to the diphtheria and tetanus antigens, was defined as: for initially seronegative subjects (pre-vaccination concentration <0.1 IU/mL): antibody concentrations at least 4 times the cut-off (post-vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least 4 times the pre-vaccination concentration.|At Month 1|The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2688165|NCT01335932|Secondary|Incidence of CMV Reactivation at Any Level at 28 Days in Throat|CMV reactivation in baseline negatives at any level at day 28 in throat|at 28 days post-randomization||||Participants|||Count of Participants
2685067|NCT01362322|Secondary|Number of Seropositive Subjects Against Diphtheria (D) and Tetanus (T) Antigens|A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 0.1. international units per milliliter (IU/mL), as assessed by the Enzyme Linked Immunosorbent Assay (ELISA).|At Day 0 (PRE) and at Month 1 (POST)|The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2685068|NCT01362322|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).|At Day 0|The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2685069|NCT01362322|Primary|Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|At Day 0|The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2685070|NCT01362322|Primary|Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter(EL.U/mL)|At Month 1|The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2685071|NCT01362322|Primary|Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations|Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|At Month 1|The analysis was performed on the According To Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||IU/mL||95% Confidence Interval|Geometric Mean
2685072|NCT01362296|Secondary|GSK1120212 Plasma Pharmacokinetic (PK) Concentration|Blood samples for PK analysis of GSK1120212 were collected at the following time points: Cycle 1 (Study Day 15), Cycle 2 (Study Day 22), Cycle 3 (Study Day 43), and Cycle 4 (Study Day 64). Post-dose PK samples collected on Day 15 of Cycle 1 occurred at least 1 hour apart. Participants were instructed to withhold the dose of GSK1120212 until after blood for PK samples had been drawn. Pre-dose samples were taken 15 minutes or less prior to taking the next dose (i.e., trough).|Day 15 of Cycle 1: pre-dose; 0.5-2 hours, 2-4 hours, and 4-8 hours post-dose; Day 1 of Cycle 2, Cycle 3 and Cycle 4: pre-dose|PK Population. Only participants with data available at the specified time points were analyzed.|||Nanograms (ng)/milliliter (mL)||Standard Deviation|Mean
2685073|NCT01362296|Secondary|Overall Survival (OS)|OS is defined as the interval of time between the date of randomization and the date of death due to any cause. For participants who did not die, OS was censored at the date of last contact.|Time interval between the date of randomization and the date of death due to any cause (maximum of 22 months)|MITT Population|||Months||95% Confidence Interval|Median
2685074|NCT01362296|Secondary|Duration of Response (DOR) as Assessed by the Investigator: Randomized Phase|DOR was assessed by the investigator for participants with CR (disappearance of all target and non-target lesions; any pathological lymph nodes must be <10 mm in the short axis; without the appearance of new lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). DOR is defined as the time from the first documented evidence of CR or PR until the earliest date of documented radiological progression or death due to any cause. PD is defined as at least a 20% increase in the sum of the diameters (SD) of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation.|Time from the first documented evidence of CR or PR until the earliest date of documented radiological progression or death due to any cause (maximum of 10.2 months)|MITT Population. Only participants who achieved a CR or PR were analyzed for duration of response.|||Weeks||95% Confidence Interval|Mean
2685075|NCT01362296|Secondary|Number of Participants With a Best Response of Either a CR or PR as Assessed by the Investigator: Crossover Phase|Response was assessed by the investigator according to RECIST, version 1.1, using confirmed and unconfirmed responses. Responders were defined as participants achieving either a CR (disappearance of all target and non-target lesions; any pathological lymph nodes must be <10 millimeters [mm] in the short axis; without the appearance of new lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing response were treated as non-responders.|From the date of the first dose of study treatment in the Crossover Phase until the first documented evidence of a CR or PR (maximum of 4 months)|Crossover Population|||Participants|||Number
2685076|NCT01362296|Secondary|Number of Participants With a Best Response of Either a Complete Response (CR) or Partial Response (PR) as Assessed by the Investigator: Randomized Phase|Response was assessed by the investigator according to RECIST, version 1.1, using confirmed and unconfirmed responses. Responders were defined as participants achieving either a CR (disappearance of all target and non-target lesions; any pathological lymph nodes must be <10 millimeters [mm] in the short axis; without the appearance of new lesions) or PR (at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters [e.g., percent change from Baseline]). Participants with unknown or missing response were treated as non-responders.|From randomization until the first documented evidence of a CR or PR (maximum of 10.2 months)|MITT Population|||Participants|||Number
2685122|NCT01362244|Secondary|Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Hemoglobin and MCHC were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Grams per liter (g/L)||Standard Deviation|Mean
2703722|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|8 weeks|||||||
2685077|NCT01362296|Secondary|Change From Baseline in Heart Rate: Crossover Phase|Heart rate was measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle therafter until treatment discontinuation.The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2685078|NCT01362296|Secondary|Change From Baseline in Heart Rate: Randomized Phase|Heart rate was measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle therafter until treatment discontinuation.The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.|||Beats per minute||Standard Deviation|Mean
2685079|NCT01362296|Secondary|Change From Baseline in SBP and DBP: Crossover Phase|Systolic and diastolic blood pressure were measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle therafter until treatment discontinuation. The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.|||mmHg||Standard Deviation|Mean
2685080|NCT01362296|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Randomized Phase|Systolic and diastolic blood pressure were measured at the following scheduled time points: Baseline; Days 1, 8, and 15 of Cycle 1 (Study Week 1); and Day 1 of every cycle thereafter until treatment discontinuation. The worst-case on-therapy was determined using both scheduled and unscheduled assessments during the on-therapy period. Change from Baseline was calculated as the value at post-Baseline time point minus the value at Baseline.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2685081|NCT01362296|Secondary|Number of Participants With Any SAE or Non-serious AE: Crossover Phase|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Medical or scientific judgment should have been exercised in deciding whether reporting was appropriate in other situations. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From the date of the first dose of study treatment in the Crossover Phase until 30 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice (maximum of 12 months)|Crossover Population|||Participants|||Number
2685082|NCT01362296|Secondary|Number of Participants With Any Serious Adverse Event (SAE) or Non-serious Adverse Event (AE): Randomized Phase|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Medical or scientific judgment should have been exercised in deciding whether reporting was appropriate in other situations. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.|From randomization until 30 days following discontinuation of study treatment regardless of initiation of a new cancer therapy or transfer to hospice (maximum of 19 months)|Safety Population|||Participants|||Number
2685083|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Crossover Phase|Data are presented for only those hematology parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Hematology parameters included: atypical lymphs, atypical lymphs (percentage [%]), basophils, eosinophils, metamyelocytes, monocytes, and myelocytes. Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.|||Participants|||Number
2685099|NCT01362244|Secondary|Pharmacokinetic/Pharmacodynamic (PK/PD) Model Derived Baseline|Blood samples were collected for the assessment of PK/PD model derived Baseline at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated participants). All available blood eosinophil count data were incorporated into the model. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, 17, 21 and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Giga units per liter||Standard Error|Least Squares Mean
2685182|NCT01362049|Primary|Change From Baseline in Numeric Pain Rating Scale (0-10 Points)|Current Pain Scale 0-10 Lower score is better/improved|Baseline and 12 months|Participants with available data are included|||units on a scale||Standard Deviation|Mean
2685084|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Hematology Parameters: Randomized Phase|Data are presented for only those hematology parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Hematology parameters included: atypical lymphs, atypical lymphs (percentage [%]), basophils, eosinophils, metamyelocytes, monocytes, myelocytes, neutrophil bands (%). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.|||Participants|||Number
2685085|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Crossover Phase|Data are presented for only those clinical chemistry parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Clinical chemistry parameters included: lactate dehydrogenase, total protein, and urea/blood urea nitrogen (BUN). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.|||Participants|||Number
2685086|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline With Respect to Normal Ranges in the Indicated Clinical Chemistry Parameters: Randomized Phase|Data are presented for only those clinical chemistry parameters for which the following worst-case on-therapy changes from Baseline with respect to the normal range were observed: decrease to low, change to normal (CTN) or no change, or increase to high. Clinical chemistry parameters included: lactate dehydrogenase, total protein, and urea/blood urea nitrogen (BUN). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments. Normal ranges for each parameter may vary depending on the laboratory (central versus local) and the participant (age, gender, etc.).|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.|||Participants|||Number
2685087|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Crossover Phase|Hematology parameters were summarized according to NCI CTCAE grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any G (IAG), G3, or G4 occurred. Hematology parameters included: haemoglobin (increased [inc]), haemoglobin (anemia), lymphocyte count (ct) (inc), lymphocyte ct (decreased [dec]), total absolute neutrophil count (ANC), platelet ct, and white blood cell count (WBC). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population. Only participants with data available at the specified time points were analyzed.|||Participants|||Number
2685088|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Hematology Parameters: Randomized Phase|Hematology parameters were summarized according to NCI CTCAE grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any G (IAG), G3, or G4 occurred. Hematology parameters included: haemoglobin (increased [inc]), haemoglobin (anemia), lymphocyte count (ct) (inc), lymphocyte ct (decreased [dec]), total absolute neutrophil count (ANC), platelet ct, and white blood cell count (WBC). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population. Only participants with data available at the specified time points were analyzed.|||Participants|||Number
2685089|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Crossover Phase|Clinical chemistry parameters were summarized according to NCI CTCAE grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any grade, Grade 3, or Grade 4 occurred. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALKP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), creatine kinase, creatinine, glucose (hyperglycemia), glucose (hypoglycemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), and sodium (hyponatremia). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Crossover Phase (up to Study Week 19)|Crossover Population: all participants who, at the point of disease progression during the Randomized Phase, elected to enter the crossover portion of the study. Only participants with data available at the specified time points were analyzed.|||Participants|||Number
2685183|NCT01362049|Primary|Change From Baseline in Numeric Pain Rating Scale (0-10 Points)|Current Pain Scale 0-10 Lower score is better/improved|Baseline and 7 weeks|Participants with available data are included|||units on a scale||Standard Deviation|Mean
2685090|NCT01362296|Secondary|Number of Participants With the Indicated Worst-case On-therapy Change From Baseline in the Indicated Clinical Chemistry Parameters: Randomized Phase|Clinical chemistry parameters were summarized according to National Cancer Institutes (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade, version 4.0. Grade (G) 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to any G, G3, or G4 occurred. Clinical chemistry parameters included: albumin, alkaline phosphatase (ALKP), alanine amino transferase (ALT), aspartate amino transferase (AST), total bilirubin, calcium (hypercalcemia), calcium (hypocalcemia), creatine kinase, creatinine, glucose (hyperglycemia), glucose (hypoglycemia), potassium (hyperkalemia), potassium (hypokalemia), sodium (hypernatremia), and sodium (hyponatremia). Worst-case on-therapy changes from Baseline were summarized. Worst-case on-therapy was defined using the on-therapy window and changes were indentified using both scheduled and unscheduled assessments.|Baseline; Days 1, 8, and 15 of Cycle 1; and Day 1 of every cycle thereafter until treatment discontinuation of the Randomized Phase (up to Study Week 40)|Safety Population: all participants (KRAS, BRAF, NRAS, and MEK1 mutation positive) that received at least one dose of study treatment, based on the actual treatment received if this differed from that to which the participant was randomized. Only participants with data available at the specified time points were analyzed.|||Participants|||Number
2685091|NCT01362296|Primary|Progression-Free Survival (PFS) as Assessed by the Investigator (INV)|PFS is defined as the time from RAN until the earliest date of documented radiological PD or DT due to any cause. PD was assessed by the INV according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. PD is defined as at least a 20% increase in the sum of the diameters (SD) of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. For participants (PAR) who did not have a documented date of PD or DT, PFS was censored at the date of the last adequate assessment. For PAR who received subsequent anti-cancer therapy prior to the date of documented PD or DT, PFS was censored at the date of the last adequate assessment prior to the initiation of therapy.|From randomization (RAN) until the earliest date of documented radiological disease progression (PD) or death (DT) due to any cause (maximum of 10.2 months)|Modified Intent-to-Treat (MITT) Population: all randomized participants with KRAS mutation-positive non-small cell lung cancer (NSCLC), whether or not treatment was administered|||Weeks||95% Confidence Interval|Median
2685092|NCT01362270|Secondary|Length of Ventilator Dependence|Number of hours of ventilator use|Number hourss subject is ventilated. Subjects are expected to be ventilator dependent an average of 120 hours. Assessed up to discharge (estimated 3 weeks).||||hours||Standard Deviation|Mean
2685093|NCT01362270|Secondary|Richmond Agitation-Sedation Scale (RAAS) Score|Measure of sedation. Scale -5 to +4, with -5 equal to 'Unarousable' and +4 equal to 'Combative.'|Median RAAS score during treatment (5 days)||||score on a scale from +4 to -5||Inter-Quartile Range|Median
2685094|NCT01362270|Primary|Success of Blinding|Care team, family and subject will be surveyed to determine success of blinding. Responses will be tallied and correlated with group assignments.|Nurse surveyed daily for length of study (five [5] days). Physician and subject (or subject's family if he/she is unable to complete the questionnaire) surveyed upon study completion, six (6) days after enrollment.|Number of participants successfully receiving assigned intervention without the care team, family, or subject knowing which treatment was given.|||Participants|||Count of Participants
2685095|NCT01362244|Secondary|Number of Participants With Positive Immunogenicity (Anti-mepolizumab Antibody Testing)|Blood samples were collected at Weeks 1, 5, 13, and 25 for anti-mepolizumab antibody testing.|Weeks 1, 5, 13, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Participants|||Number
2685096|NCT01362244|Secondary|PK/PD Model Derived Maximum Inhibition|Blood samples were collected for the assessment of Maximum Inhibition at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated participants). All available datapoints were incorporated into the model. Individual values are estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, 17, 21 and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Percentage of inhibition||Standard Error|Least Squares Mean
2685097|NCT01362244|Secondary|PK/PD Model Derived Half Maximal Effective Drug Concentration (EC50)|Blood samples were collected for the assessment of PK/PD model derived EC50 at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated participants). All available datapoints were incorporated into the model. Individual values are estimated from the model as post-hoc values after incorporating between-partcipant variability.|Weeks 1, 2, 5, 9, 13, 17, 21 and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Microgram per liter||Standard Error|Least Squares Mean
2685098|NCT01362244|Secondary|PK/PD Model Derived Coefficient of Variation of Baseline (CV[Baseline]), Variation of Maximal Effect of Drug (CV[Emax]), and Residual|A residual is the difference between the observed and predicted values. Blood samples were collected for the assessment of PK/PD model derived CV(Baseline), CV(Emax), and residual at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated subjects). All available datapoints were incorporated into the model. Individual values are estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, 17, 21 and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Percentage of variation||Standard Error|Least Squares Mean
2685119|NCT01362244|Secondary|Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|MCV was assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Femtoliters||Standard Deviation|Mean
2685184|NCT01362049|Primary|Change From Baseline in Oswestry Disability Scale (0-100%)|Disability; Sacle 0-100% Lower score is considered better/improved|Baseline and 12 Months|Participants with available data are included|||units on a scale||Standard Deviation|Mean
2685100|NCT01362244|Secondary|Half-life (Alpha) and Half-life (Beta)|Half-life (Alpha) is the rate of decline in plasma concentrations due to the process of drug redistribution from the central to the peripheral compartment and half-life (Beta ) is the rate of decline due to the process of drug elimination due to metabolism. Blood samples were collected for the assessment of half-life (Alpha) and half-life (Beta) at Weeks 1, 2, 5, 9, 13, and 25. Half-life was estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Days||Standard Error|Least Squares Mean
2685101|NCT01362244|Secondary|Area Under the Plasma Drug Concentration Versus Time Curve From Time 0 Extrapolated to Infinite Time (AUC[0-inf])|Blood samples were scheduled to be collected for the assessment of AUC(0-inf) at Weeks 1, 2, 5, 9, 13, and 25 AUC[0-inf] is derived from individual systemic clearance estimates using the expression AUC[0-inf] = Dose/CL. Hence all data are incorporated into the estimation of CL and by implication AUC[0-inf]. The actual time range over which pharmacokinetic data were collected was from time 0 to 336 days post first dose.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Microgram.day per milliliter||Standard Error|Least Squares Mean
2685102|NCT01362244|Secondary|Maximum Observed Plasma Drug Concentration (Cmax), Average Concentration (Cav[0-inf]), and Steady State Maximum Observed Plasma Drug Concentration (Cmax SS)|Blood samples were collected for the assessment of Cmax, Cav(0-inf), and Cmax SS at Weeks 1, 2, 5, 9, 13, and 25. These parameters were estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Micrograms per milliliter||Standard Error|Least Squares Mean
2685103|NCT01362244|Secondary|Steady-State Volume of Distribution|Steady-state volume of distribution is the blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces. Blood samples were collected for the assessment of steady-state volume of distribution at Weeks 1, 2, 5, 9, 13, and 25. Steady-state volume of distribution was estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Liters||Standard Error|Least Squares Mean
2685104|NCT01362244|Secondary|Bodyweight-adjusted Clearance|Clearance is the volume of plasma that would contain the amount of drug excreted per day. Blood samples were collected for the assessment of bodyweight-adjusted clearance at Weeks 1, 2, 5, 9, 13, and 25. Clearance was estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Liters per day||Standard Error|Least Squares Mean
2685105|NCT01362244|Secondary|Volume of Distribution at Weeks 1, 2, 5, 9, 13, and 25|Volume of distribution at steady-state was derived from pharmacokinetic parameter estimates of a population pharmacokinetic model. Blood samples were collected for analysis of volume of distribution at Weeks 1, 2, 5, 9, 13, and 25. All available concentrations at all available datapoints from all participants were incorporated into the model. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|PK Population. Only those participants available at the specified time points were analyzed.|||Liters||Standard Deviation|Mean
2685106|NCT01362244|Secondary|Systemic Clearance at Weeks 1, 2, 5, 9, 13, and 25|Blood samples were collected for the assessment of systemic clearance at Weeks 1, 2, 5, 9, 13, and 25. Systemic Clearance (CL) is estimated using a population-Pharmacokinetic model incorporating all available data points from all subjects. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.|Weeks 1, 2, 5, 9, 13, and 25|Pharmacokinetic (PK) Population: participants in the Safety Population for whom at least one PK sample was obtained and analyzed.|||Liters per day||Standard Deviation|Mean
2685107|NCT01362244|Secondary|VAS Score of the EQ-5D Questionnaire at Week 25 (Adjusting for Week 1 Baseline Scores)|The EQ-5D is a standardized, 2-part questionnaire used to measure health outcomes. The second part of the questionnaire is a VAS question, requiring the participant to self rate his/her health score on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state). ANCOVA model with treatment, Baseline (Week 1 scores) and country as factors was used to calculate treatment difference and confidence intervals at Week 25.|Week 1 and Week 25|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2685108|NCT01362244|Secondary|Index Score of the EuroQoL Quality of Life-5D (EQ-5D) Questionnaire at Week 25 (Adjusting for Week 1 Baseline Scores)|The EQ-5D is a standardized, 2-part questionnaire used to measure health outcomes. The first part contains descriptions of the following five components: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses to each of the five domains are measured on a 3-point scale (1-no problems, 2-some problems, and 3-severe problems). An index for the descriptive scores was derived using the general European weights, obtained for each of the countries in this study. Index scores were derived for each participant at each time point. ANCOVA model with treatment, Baseline (Week 1 scores) and country as factors was used to calculate treatment difference and confidence intervals at Week 25.|Week 1 and Week 25|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2685120|NCT01362244|Secondary|Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|MCH was assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Picograms (pg)||Standard Deviation|Mean
2685121|NCT01362244|Secondary|Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|RBC count and RC were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||10^12 cells per litre||Standard Deviation|Mean
2685109|NCT01362244|Secondary|Sino-Nasal Outcome Test (SNOT)-22 Questionnaire Total Score at Week 25 (Adjusted for Week 1 Baseline)|"SNOT-22 questionnaire is a modification of the SNOT-20 and contains the questions (ques) related to smell and nasal obstruction. Each ques is graded with a numerical score for each response (res); scores range from 0 for no symptoms to 5 for as bad as things could be. Scores for each of the ques is summed to derive the total score for that par. at that visit. If the par. did not complete any ques at a visit, then he/she were not to have any missing values imputed, and his/her total score for that visit was set to missing. If a par. had some missing scores (but no more than 50% missing at that visit), then scores for the missing resp were imputed as the mean of the non-missing resp for that par. at that visit. The SNOT-22 total score ranges from 0 to 110, with higher scores representing a worse quality of life. Questionnaire data analysis was done using an ANCOVA to obtain the LS-means, treatment difference and confidence interval at Week 25, adjusting for Week 1 Baseline scores."|Week 1 and Week 25|ITT Population|||Scores on a scale||Standard Error|Least Squares Mean
2685110|NCT01362244|Secondary|Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Sniffin'Sticks were used to assess each participant's sense of smell (olfaction). Olfaction testing results were recorded for both the right and left nostrils The worst nostril score (number of correct answers for the worst nostril) and the mean nostril score (mean number of correct answers across both nostrils) were recorded. Scores range from 0 to 12 (high score indicating normal olfactory sensation). Olfaction data are plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Scores on a scale||95% Confidence Interval|Least Squares Mean
2685111|NCT01362244|Secondary|Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Participants used a portable hand-held inspiratory flow meter to measure and record PNIF in the morning prior to taking the study medication. Three measurements were taken, and the largest measurement was recorded in the electronic diary. PNIF data is plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||L/min||95% Confidence Interval|Least Squares Mean
2685112|NCT01362244|Secondary|Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|"Participants were asked to indicate on a VAS (0 to 10 centimeters) the severity of four nasal polyposis symptoms (one VAS for each symptom): rhinorrhea; mucus in the throat; nasal blockage; loss of smell. The left-hand side of the scale (0) represents not troublesome, and the right hand side of the scale (10) represents worst possible troublesome."|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|PP Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Scores on a scale||Standard Deviation|Mean
2685113|NCT01362244|Secondary|Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 1, 2, 5, 9, 13, 17, 21, and 25|PEFR is defined as the maximum airflow generated during a forced expiration beginning with the lungs fully inflated. PEFR was calculated as the maximum of three readings taken at each time point for each participant. Spirometry data is plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Liters/minute (L/min)||95% Confidence Interval|Least Squares Mean
2685114|NCT01362244|Secondary|Mean of Forced Vital Capacity (FVC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|FVC is defined as the maximum amount of air that can forcibly be blown out after a maximum inspiration. FVC was calculated as the maximum of three readings taken at each time point for each participant. Spirometry data are plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Liters||95% Confidence Interval|Least Squares Mean
2685115|NCT01362244|Secondary|Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25|FEV1 is defined as the volume of air forcefully expelled from the lungs in one second. FEV1 measurements were taken by spirometry at each clinic visit. FEV1 was calculated as the maximum of three readings taken at each time point for each participant. Spirometry data is plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.|Weeks 2, 5, 9, 13, 17, 21, and 25|ITT Population: all randomized participants who received at least one dose of study treatment. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Liters (L)||95% Confidence Interval|Least Squares Mean
2685116|NCT01362244|Secondary|Number of Participants With Any Treatment-emergent Adverse Event (AE) and Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.|Up to Week 25|Safety Population|||Participants|||Number
2685117|NCT01362244|Secondary|Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Specific gravity, power of hydrogen (pH), glucose, protein, blood, and ketones were assessed at Weeks (Wk) 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Specific gravity, power of hydrogen (pH), glucose, protein, blood, and ketones were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25. Results for all urinalysis parameters were assessed for clinical relevance.|||participants|||Number
2685118|NCT01362244|Secondary|Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Reticulocyte count was assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Fraction of 1||Standard Deviation|Mean
2685123|NCT01362244|Secondary|Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Platelet count, WBC count, basophils, eosinophils, lymphocytes, monocytes, and neutrophils were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||10^9 cells per liter||Standard Deviation|Mean
2685124|NCT01362244|Secondary|Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Total and direct bilirubin, creatinine, and uric acid were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Micromoles per liter||Standard Deviation|Mean
2685125|NCT01362244|Secondary|Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Albumin and protein were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Grams per liter (g/L)||Standard Deviation|Mean
2685126|NCT01362244|Secondary|Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|ALT, AST, ALP, and GGT were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||International units per liter (IU/L)||Standard Deviation|Mean
2685127|NCT01362244|Secondary|Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|BUN, glucose fasting, chloride, sodium, potassium, carbon dioxide (CO2), and calcium were assessed at Weeks 1, 2, 5, 9, 13, 17, 21, and 25.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2685128|NCT01362244|Secondary|Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at Weeks 1, 2, 5, 9, 13, 17, 21, and 25. Any abnormal clinically significant (CS) and not clinically significant (NCS) findings were identified. ECG abnormaility with respect to CS and NCS findings were judged by the investigator or appropriately qualified designee.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Participants|||Number
2685129|NCT01362244|Secondary|Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25|Pulse rate was measured at Baseline (Week 1) and at Weeks 2, 5, 9, 13, 17, 21, and 25. Baseline is defined as the Week 1 pre-dose assessment. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and Weeks 2, 5, 9, 13, 17, 21, and 25|Safety Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||beats per minute||Standard Deviation|Mean
2685130|NCT01362244|Secondary|Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 21, and 25|SBP and DBP were measured at Baseline (Week 1) and at Weeks 2, 5, 9, 13, 17, 21, and 25. Baseline is defined as the Week 1 pre-dose assessment. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.|Baseline and Weeks 2, 5, 9, 13, 17, 21, and 25|Safety Population: participants who received >=1 dose of study treatment (based on actual treatment received). A participant randomized to mepolizumab took placebo in error. Thus, “N” for the placebo arm of the SP is greater than for the ITT Population. Participants available at the specified time points (represented by n=X, X) were analyzed.|||millimeters of mercury (mmHg)||Standard Deviation|Mean
2685131|NCT01362244|Secondary|Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Assessment of the nasal polyposis condition was performed after 6 months of dosing to determine the situation indicative of a reduction in the need for surgery. The components used to determine the need for surgery were endoscopic polyp scores and a severity of condition as measured by a VAS. Surgery was required for participants with ENP scores of >=3, or ENP scores of 2 and a VAS symptom score of >7.|Weeks 1, 2, 5, 9, 13, 17, 21, and 25|PP Population|||Participants|||Number
2685132|NCT01362244|Secondary|Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Screening and Weeks 1, 2, 5, 9, 13, 17, 21, and 25|Each nostril was assessed for polyps and graded at Screening and at Weeks 1, 2, 5, 9, 13, 17, 21, and 25. The ENP score ranges from 0 (no polyps) to 4, with a higher score indicating a larger polyp. The ENP score was recorded for both the right and the left nostril. The higher of the two scores was derived and used for the analysis.|Screening; Weeks 1, 2, 5, 9, 13, 17, 21, and 25|PP Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.|||Participants|||Number
2685133|NCT01362244|Primary|Number of Participants With a Reduced Need for Surgery at the End of the Study (Week 25)|Assessment of the nasal polyposis condition was performed after six months of dosing to determine the situation indicative of a reduction in the need for surgery. The components used to determine the need for surgery were endoscopic polyp scores and a severity of condition as measured by a visual analogue scale (VAS). Surgery was still deemed required for a participant with an ENP score of >=3, or an ENP score of 2 and a VAS symptom score of >7. The number of participants with reduced need for polyp surgery are presented as missing data set to non-responders (NR) and missing data last observation carry forward (LOCF). LOCF is defined as missing responses at Week 25 imputed with the last non-missing post-dose observation for that participant.|Week 25|Per Protocol Population: all randomized participants who received at least one dose of study treatment and who complied with the protocol.|||Participants|||Number
2685134|NCT01362205|Secondary|Resource Utilization Costs Associated With This Hospitalization Billed by Facility.||Up to 28 days|The overall number of participants analyzed is less than the number randomized as data was not available for research use at many of the participating institutions.|||USD||Inter-Quartile Range|Median
2685135|NCT01362205|Secondary|Resource Utilization Costs Associated With This Hospitalization Billed by Physicians.||up to 28 Days||||Dollar (United States)||Inter-Quartile Range|Median
2685136|NCT01362205|Secondary|Scores at Hospital Discharge on the PTSD Civilian Checklist|PTSD checklist consists of 17 questions graded on a scale of 1 to 5. The PTSD score is comprised from the sum of the scores 17 questions. The PTSD score has possible values from to 17 to 85 with higher values indicating greater symptom severity.|Up to 28 days|The number of participants analyzed was lower than the total included as many patients were discharged quickly upon resolution of altered mental status when a research team member was unavailable to administer the questionnaires.|||units on a scale||Inter-Quartile Range|Median
2685137|NCT01362205|Secondary|Scores at Hospital Discharge on the Beck Anxiety Inventory|The Beck Anxiety Inventory is a validated questionnaire used to measure severity of anxiety (min score 0, max score 63). The higher the score the greater the severity of anxiety. A score of 30-63 indicates severe anxiety, 17-29 moderate anxiety, 10-16 mild anxiety and 0-9 minimal anxiety.|Up to 28 days.||||units on a scale||Standard Deviation|Mean
2685138|NCT01362205|Secondary|Scores at Hospital Discharge on the Beck Depression Inventory.|The Beck Depression Inventory is a validated questionnaire used to measure severity of depression (min score 0, max score 63). The higher the score the greater the severity of depression. A score of 30-63 indicates severe depression, 19-29 moderate depression, 10-18 mild depression and 0-9 minimal depression.|Up to 28 days.||||units on a scale||Standard Deviation|Mean
2685139|NCT01362205|Secondary|Scores at Hospital Discharge on the Mini Mental Exam.|The Mini Mental State Examination or Folstein test is a validated 30-point questionnaire used to measure cognitive impairment (min score 0, max score 30). A score of 24 points (out of a max of 30) indicates normal cognition, less than or equal to 9 points indicates severe impairment, 10-18 indicates moderate impairment and 19-23 mild impairment.|up to 28 days||||units on a scale||Standard Deviation|Mean
2685140|NCT01362205|Secondary|The Length in Days of the Hospital Stay|A hospital day is counted for any time on a calendar day the patient is admitted to the hospital. Hospital days are inclusive of ICU days.|up to 28 days||||days||Inter-Quartile Range|Median
2685141|NCT01362205|Secondary|Number of Ventilator Free Days After Randomization.|A ventilator day is counted for any use of invasive mechanical ventilation during a calendar day|up to 28 days||||days||Inter-Quartile Range|Median
2685142|NCT01362205|Secondary|The Number of CAM-ICU Negative Days After Randomization.|The Confusion Assessment Method (CAM)-ICU is a validated instrument used to detect the presence or absence of delirium in the ICU. A delirium free day is counted for any day a patient is negative by the CAM-ICU. The higher the number of CAM-ICU negative days indicates the more days a patient was able to think clearly.|up to 28 days||||days||Inter-Quartile Range|Median
2685143|NCT01362205|Secondary|Average MINDS Score|Minnesota Detoxification Scale (MINDS) min score 0, max score 46. The higher the score, the worse the symptoms of AWS/AWD.|up to 28 days||||units on a scale||Inter-Quartile Range|Median
2685144|NCT01362205|Primary|The Length of ICU Stay Defined as the Time Between Randomization and ICU Transfer Orders.||up to 28 days in hours||||hours||Inter-Quartile Range|Median
2685145|NCT01362192|Secondary|Mean Pain Score Associated With Laser Treatment|Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).|12 weeks (2nd laser treatment)|intent-to-treat|||Numeric Pain Rating Score||Standard Deviation|Mean
2685146|NCT01362192|Secondary|Mean Pain Score Associated With Laser Treatment.|Subjects will be asked to rate the average pain experienced during laser treatments using the 0-10 numeric pain rating scale (0 = no pain to 10 = worst possible pain).|Day 0 (1st laser treatment)|intent-to-treat|||Numeric Pain Rating Score||Standard Deviation|Mean
2685147|NCT01362192|Secondary|Percent of Subjects Satisfied With Improvement of Treated Spider Veins.|"Subjects will assess their satisfaction with the procedure and with the improvement in lower extremity spider veins at twelve weeks post final laser treatment based using the following scale:~1 = Very Much Not Satisfied~2 = Not Satisfied~3 = Somewhat Satisfied~4 = Satisfied~5 = Very Much Satisfied"|24 weeks (12 weeks post-final laser treatment)|per protocol|||percent of participants|||Number
2685148|NCT01362192|Secondary|"Percent of Subjects With Significant to Very Significant Improvement of Lower Extremity Spider Veins, as Assessed by Subject."|"Subjects will be asked to rate the improvement of each treated area of their lower extremity spider veins as compared to baseline using the following scale:~0 = No Improvement (0%)~1 = Mild Improvement (< 25%)~2 = Moderate Improvement (26 to 50%)~3 = Significant Improvement (51 to 75%)~4 = Very Significant Improvement (76 to 100%)"|24 weeks (12 weeks post-final laser treatment)|per protocol|||percent of participants|||Number
2685149|NCT01362192|Secondary|"Percent of Subjects With Significant or Very Significant Improvement in Lower Extremity Spider Veins, as Assessed by the Treating Investigator."|"The Investigator will perform the Physician's Global Assessment of the degree of improvement for each treated area of the subject's lower extremity spider veins using the following scale:~0 = No Improvement (0%)~1 = Mild Improvement (< 25%)~2 = Moderate Improvement (26 to 50%)~3 = Significant Improvement (51 to 75%)~4 = Very Significant Improvement (76 to 100%)"|24 weeks (12 weeks post-final laser treatment)|per protocol|||percent of participants|||Number
2685150|NCT01362192|Secondary|Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments|"The panel of independent physicians will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale:~0 = No Improvement (0%)~1 = Mild Improvement (< 25%)~2 = Moderate Improvement (26 to 50%)~3 = Significant Improvement (51 to 75%)~4 = Very Significant Improvement (76 to 100%)"|12 weeks (post-1st laser treatment)|per protocol|||points on Improvement scale||95% Confidence Interval|Mean
2685151|NCT01362192|Primary|Mean Improvement of Lower Extremity Spider Veins Based on Blinded Photo Assessments|"A panel of independent physicians will assess before and after digital photographs of each treated area. The physicians will be blinded to the treatment parameters and to the temporal order of the before and after photographs. Each independent physician will be asked to select the baseline photograph for each treated area and then rate the degree of improvement using the following scale:~0 = No Improvement (0%)~1 = Mild Improvement (< 25%)~2 = Moderate Improvement (26 to 50%)~3 = Significant Improvement (51 to 75%)~4 = Very Significant Improvement (76 to 100%)"|24 weeks (12 weeks post-final laser treatment)|per protocol|||points on Improvement scale||95% Confidence Interval|Mean
2685185|NCT01362049|Primary|Change From Baseline in Oswestry Disability Scale (0-100%)|Disability; Sacle 0-100% Lower score is considered better/improved|Baseline and 7 weeks|Participants with available data are included|||units on a scale||Standard Deviation|Mean
2685152|NCT01362140|Secondary|Percentage of Participants With a Clinically Meaningful Improvement in Fatigue|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~Clinically meaningful improvement in fatigue is defined as an increase of ≥ 3 points in the FACIT-Fatigue subscale score, from baseline to EOTP."|Baseline to week 24|FACIT-fatigue analysis set|||percentage of participants||95% Confidence Interval|Number
2685153|NCT01362140|Secondary|Change From Baseline in EuroQol-5D (EQ-5D) Visual Analog Scale (VAS)|"The EQ-5D visual analog scale (VAS) is a global evaluation of overall health state with scores ranging from 0 (worse health state a participant can imagine) to 100 (best health state a participant can imagine).~End of treatment period (EOTP) analysis includes last available values."|Baseline, and weeks 13 and 25|The EQ-5D visual analog analysis set includes all participants in the primary analysis set who completed both the baseline and at least 1 subsequent visual analog scale.|||units on a scale||Standard Deviation|Mean
2685154|NCT01362140|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)|"The FACIT-Fatigue scale was a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means not at all, and 4 means very much. The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.~A positive change from baseline score indicates an improvement. End of treatment period (EOTP) analysis includes last available values."|Baseline, and weeks 13 and 25|FACIT-Fatigue Analysis Set, includes all participants in the primary analysis set who completed or partially completed both the baseline and at least 1 subsequent FACIT-F questionnaire.|||units on a scale||Standard Deviation|Mean
2685155|NCT01362140|Secondary|Number of Participants Who Developed Neutralizing Antibodies to Darbepoetin Alfa|"Two validated assays were used to detect the presence of anti-darbepoetin alfa antibodies.~Samples were first tested in an immunoassay to detect antibodies capable of binding to darbepoetin alfa. Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based assay to determine neutralizing activity against darbepoetin alfa. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies.~The number of participants who developed antibodies to darbepoetin alfa is defined as participants who were neutralizing antibody positive post-baseline with a negative or no result at baseline."|Baseline and end of double-blind treatment period (24 weeks)|Safety analysis set participants with post-baseline antibody results|||participants|||Number
2685156|NCT01362140|Secondary|Number of Participants With Malignancies Other Than AML, Basal Cell Carcinoma, or Squamous Cell Carcinoma of the Skin||Up to 24 weeks|Safety analysis set|||participants|||Number
2685157|NCT01362140|Secondary|Number of Participants With Disease Progression to Acute Myeloid Leukemia (AML)|Transformation to AML was assessed according to WHO guidelines in the absence of IP and any haematopoietic growth factors (2 weeks off dosing). Bone marrow and/or cytogenetic report confirmation of AML was required (marrow or peripheral blast cells ≥ 20%, presence of pathognomic AML cytogenetic change, or evidence of marrow blast criteria for erythroleukemia). A pathology report confirming other leukemias such as chloroma (granulocytic sarcoma, myeloid sarcoma) or leukemia cutis also constituted transformation to AML.|24 weeks|Safety analysis set with available data|||participants|||Number
2685158|NCT01362140|Secondary|Number of Participants With Adverse Events|"The severity of each adverse event was graded using the the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grading scale, where grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening and grade 5 = death.~Prespecified adverse events of interest for darbepoetin alfa, based on clinical data in anemic patients with cancer, included the following categories: hypersensitivity, cardiac failure, hypertension, malignancies, embolic and thrombolic events, venous thromboembolic events (VTEs), central nervous system vascular disorders, and ischemic heart disease."|From first dose of study drug until the end of the double-blind treatment period; 24 weeks.|Safety Analysis Set, including all participants who received at least 1 dose of study drug. One participant in the placebo arm inadvertently received a dose of darbepoetin alfa and is counted in the darbepoetin alfa group for safety analyses.|||participants|||Number
2685159|NCT01362140|Secondary|Percentage of Participants Who Achieved an Erythroid Response Based on International Working Group (IWG) 2006 Criteria in the Double-blind Treatment Period|"International Working Group 2006 erythroid response was defined as achieving an initial ≥ 1.5 g/dL increase in hemoglobin from baseline and sustaining an average rise of ≥ 1.5 g/dL in a rolling 56-consecutive day period in the absence of RBC transfusion.~Participants with no hemoglobin collected to the minimum time required to observe an IWG erythroid response (Week 13) were considered non-responders."|Up to 24 weeks|Primary analysis set participants with a central laboratory baseline hemoglobin value|||percentage of participants||95% Confidence Interval|Number
2685160|NCT01362140|Primary|Percentage of Participants With at Least One Red Blood Cell (RBC) Transfusion During the Double-blind Treatment Period||Week 5 to Week 25|Transfusion Primary Analysis Set which includes all randomized and consented participants who received at least 1 dose of study drug and who had an end of treatment period (EOTP) visit ≥ day 29 (ie, start of week 5).|||percentage of participants|||Number
2685161|NCT01362127|Secondary|HRQOL and Swallowing Function|The European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire QLQ-C30 and disease specific questionnaires (QLQ-OES24/OG25). All items included in the questionnaires are analysed and also separate analysis of dysphagia questionnaires for oesophageal cancer were used, both clinically and psychometrically validated. All questions have four response alternatives (1, not at all; 2:a little, 3: quite a bit, 4: very much), except global scales which comprise seven response alternatives from poor to excellent. Questionnaire responses were transformed lineraly into scores ranging from 0 to 100 according to the EORTC scoring manual. A higher score indicates either more symotoms or better function, depending on the question.|Entry study up to Five years follow up|Number of patients who responded to quality of Life instruments the EORTC QLQ-C30 and the oesophageal specific instrument|||units on a scale||95% Confidence Interval|Mean
2685162|NCT01362127|Secondary|Safety of Respective Neoadjuvant Therapies.|Safety profile of carrying out radical surgery after respective neoadjuvant therapy.|Five years follow up||||Participants|||Count of Participants
2685163|NCT01362127|Primary|Pathological Complete Histological Response (pCR) After Resection Than Chemotherapy Alone in Patients With Resectable Carcinoma of the Esophagus and Cardia.|Chireac tumour regression grade|Therapy followed in 14-16 weeks before surgery. After surgery the patients will be followed until 60 weeks after completed therapy.||||Participants|||Count of Participants
2685164|NCT01362062|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Every Visit|HAQ-DI is a self-completed patient questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. The HAQ-DI is the sum of the scores from all domains and ranged from 0 (best) to 24 (worst). A negative change from baseline indicated improvement.|Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.|||units on scale||Standard Deviation|Mean
2685165|NCT01362062|Secondary|Participant's Assessment of Pain Using VAS: Mean Change From Baseline at Every Visit|"The participant assessed their pain on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm, and is described as unbearable pain. A negative change indicated improvement."|Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.|||millimeters||Standard Deviation|Mean
2685166|NCT01362062|Secondary|Physician's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit|"The physician's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, and is described as maximum disease activity (maximum arthritis disease activity)."|Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.|||millimeters||Standard Deviation|Mean
2685167|NCT01362062|Secondary|Participant's Global Assessment of Disease Activity Using VAS: Mean Change From Baseline at Every Visit|"The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, and is described as maximum disease activity (maximum arthritis disease activity). A negative change from baseline indicated improvement."|Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.|||millimeters||Standard Deviation|Mean
2685168|NCT01362062|Secondary|Change From Baseline in C-Reactive Protein (CRP) Levels at Every Visit||Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.|||milligrams per deciliter (mg/dL)||Standard Deviation|Mean
2685169|NCT01362062|Secondary|Change From Baseline (CFB) in ESR Values at Every Visit||Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.|||mm/hour||Standard Deviation|Mean
2685170|NCT01362062|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50, ACR70 and ACR90 Responses at Every Visit|ACR20/ACR50/ACR70/ACR 90 response: greater than or equal to (≥) 20%/50%/70%/90% improvement in tender and swollen joint counts and 20%/50%/70%/90% improvement in 3 of the following 5 criteria: 1) Physician's global assessment of disease activity, 2) Participant assessment of disease activity, 3) Participant assessment of pain (VAS), 4) participant assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) ESR at each visit.|Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 42), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.|||percentage of participants|||Number
2685171|NCT01362062|Secondary|Time Taken to Achieve Remission (DAS28 <2.6 Units)|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). Remission is defined as DAS28 value of <2.6 units at the time of assessment. Time taken to achieve remission is reported.|Up to 12 months|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.|||days||Full Range|Mean
2685186|NCT01361919|Secondary|Ventilations|ventilations per minute over 5 minute test sequence and overall number for 5 minutes|baseline||||number per minute||Standard Deviation|Mean
2685187|NCT01361919|Primary|CPR Rate|rate of chest compression per minute|baseline||||compressions per minute||Standard Deviation|Mean
2685188|NCT01361919|Primary|CPR Depth|Depth of chest compressions measured in millimeters|baseline||||millimeters||Standard Deviation|Mean
2685189|NCT01361867|Secondary|Step Height Adaptation|The percentage of the step height change caused by the mechanical perturbation that subjects compensate for|within a trial of the experiment (i.e. a few minutes)||||% step height compensated for||Standard Error|Mean
2685172|NCT01362062|Secondary|Percentage of Participants Achieving Remission (DAS28 <2.6 Units) at Every Visit|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). Remission is defined as DAS28 value of <2.6 units at the time of assessment.|Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.|||percentage of participants|||Number
2685173|NCT01362062|Secondary|Time Required to Achieve Low Disease Activity (DAS28 <3.2 Units)|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low disease activity is defined as decrease in DAS28 to a value <3.2 Units at the time of assessment. Time taken to achieve low disease activity was reported.|Up to 12 months|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.|||days||Full Range|Mean
2685174|NCT01362062|Secondary|Percentage of Participants Achieving Low Disease Activity (DAS28 Less Than [<] 3.2 Units) at Every Visit|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Low Disease Activity is defined as DAS28 value of <3.2 Units at the time of assessment.|Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.|||percentage of participants|||Number
2685175|NCT01362062|Secondary|Time Required to Achieve Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)|DAS28 was calculated from the TJC of 28 joints, SJC of 28 joints, ESR (in mm/hour), and the participant's global assessment of disease activity (100 mm VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*√(TJC) + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A reduction of at least 1.2 units of DAS28 score from previous visit is considered as clinically meaningful improvement. Time taken to achieve clinically meaningful improvement in DAS28 was reported.|Up to 12 months|Efficacy analysis population. Number of participants analyzed = number of participants evaluable for this outcome.|||days||Full Range|Mean
2685176|NCT01362062|Secondary|Percentage of Participants Achieving a Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) (Reduction of At Least 1.2 Units) at Every Visit|DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, erythrocyte sedimentation rate (ESR) (in millimeters [mm]/hour), and the participant's global assessment of disease activity (100 mm visual analog scale [VAS]: 0 mm=no disease activity to 100 mm=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56*square root (√) of TJC + 0.28*√(SJC) + 0.70*log natural (ESR) + 0.014*global assessment of disease activity (100 mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A reduction of at least 1.2 units of DAS28 score from previous visit is considered as clinically meaningful improvement.|Visit 3 (Week 4), Visit 4 (Week 8), Visit 5 (Week 12), Visit 6 (Week 16), Visit 7 (Week 20), Visit 8 (Week 24), Visit 9 (Week 28), Visit 10 (Week 32), Visit 11 (Week 36), Visit 12 (Week 40), Visit 13 (Week 44)|Efficacy analysis population included participants who were observed prospectively in this study. Number of participants analyzed = number of participants evaluable for this outcome and n = number of participants evaluable at the specified time point.|||percentage of participants|||Number
2685177|NCT01362062|Primary|Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs)|An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal product. An AE is considered as an SAE if it fulfills one of the following criteria: a) fatal or life-threatening, b) requires in-patient hospitalization or prolongation of existing hospitalization, c) results in a persistent or significant disability, d) results in a congenital abnormality/birth defect, e) is medically significant. AEs included serious as well as non-serious AEs.|Up to 12 months|Safety analysis population: Included all participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2685178|NCT01362049|Secondary|Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)|fear-avoidance beliefs about physical activity Scale for Physical Activity 0-24; sum items 2, 3, 4, 5. Higher score indicates higher fear beliefs about physical acitivty|Baseline and 12 months|Participants with available data are included|||units on a scale||Standard Deviation|Median
2685179|NCT01362049|Secondary|Change From Baseline in Fear Avoidance Belief Questionnaire (Physical Activity Subscale 0-24 Points)|fear-avoidance beliefs about physical activity Scale for Physical Activity 0-24; sum items 2, 3, 4, 5. Higher score indicates higher fear beliefs about physical acitivty|Baseline and 7 weeks|Participants with available data are included|||units on a scale||Standard Deviation|Mean
2685180|NCT01362049|Secondary|Change From Baseline in SF-36 Health Survey (0-100 Points)|Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state|Baseline and 12 months|Participants with available data are included|||units on a scale||Standard Deviation|Mean
2685181|NCT01362049|Secondary|Change From Baseline in SF-36 Health Survey (0 - 100 Points)|Quality of Life - Physical Component Scale: 0-100 Higher score defines a more favorable health state|Baseline and 7 weeks|Participants with available data are included|||units on a scale||Standard Deviation|Mean
2685200|NCT01361633|Primary|California Verbal Learning Test-II (CLVT-II)|The CLVT-II is an assessment of verbal learning and memory which measures recall and recognition scores, encoding strategies, learning rates and error types. A list learning task with 16 words from 4 semantic categories are read over a series of 5 list presentations. Recall is assessed after learning and at a 20-minute delay. Software produces a report that computes raw and standardized scores. Our dependent variable was the age adjusted t-score for total number of words recalled after 5 trials. A higher score indicated better recall. The maximum possible score was 80 and a minimum was 0.|Outcome measures will be collected during a single neuropsychological testing administration lasting approximately 3 hours without patient follow up. Scores for the experimental and control group were compared.||||age adjusted t-scores||Standard Deviation|Mean
2685201|NCT01361620|Primary|Whole Blood Coagulation|Whole blood coagulation after stimulation with arachidonic acid, as measured in the VerifyNow Aspirin system (Accumetrics). Aspirin response units (ARU) are the residual coagulation present in patients taking aspirin. The higher the ARU, the greater residual coagulation (resistance) to the aspirin effect.|Single measurement at 7-10 days after beginning aspirin||||Aspirin response units (ARU)||Standard Deviation|Mean
2685202|NCT01361607|Secondary|Change From Baseline In NRS Constipation At Last Visit (Up To Day 36)|"Participants indicated level of constipation on an 11-point NRS, where a score of 0 was no constipation, and 10 was constipation as bad as you can imagine. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36.~Change in NRS constipation score was calculated as: Last Visit NRS constipation score - Baseline NRS constipation score.~A negative value indicates improvement in condition from Baseline."|Baseline, Last Visit (up to Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
2685203|NCT01361607|Secondary|Change From Baseline In Daily Break-through Opioid Dose (Morphine Equivalent) At End Of Treatment|"Daily break-through opioid dose usage was calculated as the product of prescribed dose per use, and the number of uses per day. If participants took more than 1 different break-through opioid for more than 1 day, the sum of morphine equivalence dose usages for each break-through opioid was calculated for the summary.~Change in daily break-through opioid dose was calculated as: End of Treatment daily break-through opioid dose - Baseline daily break-through opioid dose.~A negative value indicates a decrease in dose from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||mg (morphine equivalent)||Standard Deviation|Mean
2685204|NCT01361607|Secondary|Change From Baseline In Daily Maintenance Opioid Dose (Morphine Equivalent) At End of Treatment|"The prescribed daily quantity of opioid maintenance dose was calculated as the product of dose per use and daily frequency of use. Participants were asked: Have you used your maintenance dose painkiller today as prescribed? If the participant answered No to the question, the daily opioid maintenance dose usage on that day was set to 0.~Change in daily maintenance opioid dose was calculated as: End of Treatment daily maintenance opioid dose - Baseline daily maintenance opioid dose.~A negative value indicates a decrease in dose from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||mg (morphine equivalent)||Standard Deviation|Mean
2685205|NCT01361607|Secondary|Change From Baseline In Daily Total Opioid Use (Morphine Equivalent) At End Of Treatment|"The total daily opioid use (in morphine equivalence) was the sum of morphine equivalence of daily maintenance dose and break-through dose.~Change in daily total opioid use was calculated as: End of Treatment daily total opioid use - Baseline daily total opioid use.~A negative value indicates a decrease in use from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||mg (morphine equivalent)||Standard Deviation|Mean
2685206|NCT01361607|Secondary|Patient Satisfaction Questionnaire At Last Visit (Up To Day 36)|"The Patient Satisfaction Questionnaire (PSQ) was used to assess level of satisfaction of the participant with the study drug, with the markers extremely satisfied, very satisfied, slightly satisfied, neutral, slightly dissatisfied, very dissatisfied, extremely dissatisfied. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36."|Last Visit (up to Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||Participants|||Count of Participants
2685207|NCT01361607|Secondary|Physician Global Impression Of Change At Last Visit (Up To Day 36)|"The Physician Global Impression of Change (PGIC) was used by the treating physician (investigator/sub-investigator) to assess if there was any change in the general functional abilities of the participant since prior to commencement of study medication, with the markers: very much worse, much worse, slightly worse, no change, slightly improved, much improved, very much improved. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36."|Last Visit (up to Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||Participants|||Count of Participants
2685208|NCT01361607|Secondary|Subject Global Impression Of Change At Last Visit (Up To Day 36)|"The Subject Global Impression of Change (SGIC) was used to assess the overall status of the participant related to their cancer pain, with the markers very much improved, much improved, slightly improved, no change, slightly worse, much worse, or very much worse. The SGIC was assessed at Day 36 or at which a participant's last evaluation was performed, such as in the case of early termination. Last visit refers to the last visit that a participant completed the assessment; this could be either Day 22 or Day 36."|Last visit (up to Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||Participants|||Count of Participants
2703723|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|6 weeks|||||||
2685209|NCT01361607|Secondary|Change From Baseline In Mean Sleep Disruption NRS At End Of Treatment|"Participants indicated the level of sleep disruption experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated did not disrupt sleep and a score of 10 indicated completely disrupted (unable to sleep at all). Change in mean sleep disruption NRS was calculated as: End of Treatment sleep disruption NRS score - Baseline sleep disruption NRS score.~A negative value indicates an improvement in sleep disruption score from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
2685210|NCT01361607|Secondary|Change From Baseline In Mean NRS Worst Pain At End Of Treatment|"Participants indicated the level of worst pain experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Change in mean NRS worst pain was calculated as: End of Treatment NRS worst pain score - Baseline NRS worst pain score.~A negative value indicates an improvement in worst pain score from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
2685211|NCT01361607|Secondary|Change From Baseline In Mean NRS Average Pain At End Of Treatment|"Participants indicated the level of pain experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Change in mean NRS average pain was calculated as: End of Treatment NRS average pain score - Baseline NRS average pain score.~A negative value indicates an improvement in average pain score from Baseline."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||units on a scale||Standard Deviation|Mean
2685212|NCT01361607|Primary|Percent Improvement From Baseline In Mean NRS Average Pain At End Of Treatment|"Participants indicated level of pain in the last 24 hours on an 11-point Numerical Rating Scale (NRS), where a score of 0 was no pain and 10 was pain as bad as you can imagine. Baseline = mean score from first day of 3-day eligibility period through to the day before first dose of study drug. End of Treatment = mean score over last (up to) 7 days to the final pain score at End of Treatment or up until Day 35, whichever is earlier, or final score available (prematurely terminated).~Percentage improvement from baseline (Imp%) was calculated as:~Imp% = (Baseline pain NRS mean - End of Treatment pain NRS mean)/Baseline pain NRS mean * 100.~For participants who died or withdrew due to disease progression, Imp% values were used. For participants who died or withdrew, unrelated to disease progression, before end of Week 5 (no diary data from Day 33 onwards), Imp% was zero for participants whose Imp% value was positive and it was Imp% for participants whose Imp% value was not positive."|Baseline, End of Treatment (Day 36)|The ITT Population included all participants who were randomized, received at least 1 dose of study drug, and had at least 1 efficacy endpoint. Participants were analyzed according to the treatment group they were randomized to.|||percent improvement||Inter-Quartile Range|Median
2685213|NCT01361594|Secondary|Cerebrovascular Events|permanent stroke and reversible ischemic neurologic deficit|within 3 months after discharge|||||||
2685214|NCT01361594|Secondary|Pneumonia (CDC Criteria)|Pneumonia (CDC criteria)|Within 3 months after discharge|||||||
2685215|NCT01361594|Secondary|Surgical Wound Infection|Superficial and deep sternal wound infection|within 3 months after discharge|||||||
2685216|NCT01361594|Secondary|Major Cardiovascular Events|"Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty).~Congestive heart failure~Cardiac arrhythmias: malignant arrhythmia"|within 3 months after discharge|||||||
2685217|NCT01361594|Secondary|Measures of Inflammation|Measures of inflammation (C-reactive protein, TNF-alpha; IL-6) and oxidative stress markers|average 1 month during the hospitalization|||||||
2685218|NCT01361594|Secondary|Incidence of Organ Failures Assessed by the Daily SOFA Score|Incidence of organ failures assessed by the daily SOFA score|average 1 month during the hospitalization|||||||
2685219|NCT01361594|Secondary|Number of Hospital Readmissions and Emergency Room Visits|Number of hospital readmissions and emergency room visits|Within 30 days after discharge|||||||
2685220|NCT01361594|Secondary|Thirty Day Mortality|Thirty day mortality|within 30 days of discharge|||||||
2685221|NCT01361594|Secondary|Duration of Ventilatory Support and ICU Readmission|Duration of ventilatory support and ICU readmission|average 1 month during the hospitalization|||||||
2685222|NCT01361594|Primary|Hospital Mortality|Mortality is defined as death occurring during admission, either during ICU or after transition to non-ICU admission.|average 1 month during the hospitalization||||participants|||Number
2685223|NCT01361594|Secondary|Cerebrovascular Events|permanent stroke and reversible ischemic neurologic deficit.|average 1 month during the hospitalization|||||||
2685224|NCT01361594|Secondary|Pneumonia (CDC Criteria)|Pneumonia (CDC criteria)|average 1 month during the hospitalization|||||||
2685225|NCT01361594|Secondary|Surgical Wound Infection|superficial and deep sternal wound infection|average 1 month during the hospitalization|||||||
2685226|NCT01361594|Secondary|ICU and Hospital Length of Stay, and ICU Readmissions|ICU and hospital length of stay, and ICU readmissions|average 1 month during the hospitalization|||||||
2685227|NCT01361594|Secondary|Respiratory Failure, Defined as PaO2 Value < 60 mm Hg While Breathing Air or a PaCO2 > 50 mm Hg.|Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg.|average 1 month during the hospitalization|||||||
2685228|NCT01361594|Secondary|Acute Renal Failure|new-onset abnormal renal function: serum creatinine > 2.0 mg/dL or an increment level > 50% from baseline|average 1 month during the hospitalization|||||||
2695297|NCT01280604|Primary|Triglyceride Levels|Triglyceride levels will be assessed in study participants 6-10 weeks after entry into study.|6-10 weeks||||milligram/deciliter||Standard Deviation|Mean
2685229|NCT01361594|Secondary|Major Cardiovascular Events|"Acute myocardial infarction : (1) typical increase and gradual decrease (troponin) or (2) more rapid increase and decrease (creatine kinase MB) of biochemical markers of myocardial necrosis with at least one of the following: (a) ischemic symptoms, (b) development of pathologic Q waves on the electrocardiogram, (c) electrocardiographic changes indicative of ischemia (ST-segment elevation or depression), or (d) coronary artery intervention (e.g., coronary angioplasty).~Congestive heart failure~Cardiac arrhythmias: malignant arrhythmia"|average 1 month during the hospitalization|||||||
2685230|NCT01361594|Secondary|Glycemic Control|"Hyperglycemic events (BG > 200 mg/dL) in ICU and non-ICU~Hypoglycemic events (BG < 70 mg/dl; severe hypoglycemia (BG < 40 mg/dl)."|average 1 month during the hospitalization|||||||
2685231|NCT01361594|Primary|Number of Subjects That Were Diagnosed for Peri-operative Complications|Number of participants that presented at least 1 complications including sternal wound infection, bacteremia, acute renal failure, respiratory failure, and major cardiovascular events (MACE) during the current hospitalization and up to 6 months after hospitalization|Within 6 months of hospitalization||||participants|||Number
2685232|NCT01361568|Secondary|Total Number of Patients Reporting At Least One Episode of Vomiting||Up to 24 hours|All patients in the modified Intent-to-Treat (mITT) population and compared patients that received any dose of CR845 (preoperatively and/or postoperatively) to patients that only received placebo.|||percentage of patients|||Number
2685233|NCT01361568|Secondary|Total Number of Patients Reporting At Least One Episode of Nausea||Up to 24 hours|All patients in the modified Intent-to-Treat (mITT) population and compared patients that received any dose of CR845 (preoperatively and/or postoperatively) to patients that only received placebo.|||percentage of patients|||Number
2685234|NCT01361568|Secondary|Global Evaluation Responder Analysis|"Responders = Excellent or Very Good; Non-Responders = Fair or Poor. Patient who reported a score of Good were not included in the analysis as the midpoint cannot be unambiguously assigned for a binary outcome measurement."|At 24 hours|The responder analysis included all patients in the modified Intent-to-Treat (mITT) population and compared patients that received any dose of CR845 (preoperatively and/or postoperatively) to patients that only received placebo.|||Responder Count|||Number
2685235|NCT01361568|Secondary|Total Pain Relief Within the First 2 Hours (TOTPAR 0-2) Following Postoperative Study Drug Treatment Using LOCF|"Patients reported their pain relief using a 5-point categorical scale of 0 to 4 (0 = No Relief, 1 = A Little Relief, 2 = Some Relief, 3 = A Lot of Relief and 4 = Complete Relief). TOTPAR 0-2 was represents the cumulative time-weighted sum of the pain relief (PR) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 15 to 30 min, 30 to 45 min, etc.) over the first 2 hours. Pain relief assessments were measured at 15, 30, 45, 60, 90, 120 minutes after the start of the infusion of study drug following surgery.~Positive TOTPAR values represent an increase in pain relief."|0 to 2 hours|The analysis included all patients in the modified Intent-to-Treat (mITT) population who re-randomized in the postoperative period, where time 0 was the start time of the postoperative study drug infusion, and did not have a missing baseline pain intensity score.|||units on a scale * hours||Standard Error|Mean
2685236|NCT01361568|Secondary|Morphine Consumption Following Postoperative Study Drug Treatment in the 2-24 Hour Period After Recovery in the Post-Anesthesia Care Unit (Post-PACU)||2 to 24 hours (post-PACU)|The analysis included all patients in the modified Intent-to-Treat (mITT) population who re-randomized in the postoperative period, where time 0 was the start time of the postoperative study drug infusion. Morphine consumption was calculated for the 2-24 hour period, after patients were transferred out of the PACU.|||mg||Standard Error|Mean
2685237|NCT01361568|Secondary|Summed Pain Intensity Difference From 0-24 Hours (SPID 0-24) Following Postoperative Study Drug Treatment Using Last Observation Carried Forward (LOCF)|"Patients reported their pain intensity using a visual analogue scale (VAS) from 0 to 100 mm, where 0 mm represented No Pain and 100 mm represented the Worst Pain You Can Imagine. SPID 0-24 represents the cumulative time-weighted sum of the pain intensity difference (PID) scores between each assessment timepoint following the postoperative administration of study drug (i.e. 0 to 15 min, 15 to 30 min, etc.) over 24 hours. Pain intensity assessments were measured at baseline (entry pain score), then at 15, 30, 45, 60, 90, 120, 150, 180, 240, 360, 480, 720, 960, and 1440 minutes after the start of the infusion of study drug following surgery.~Negative SPID values represent a decrease in pain intensity (i.e. lower values indicate a greater reduction in pain)."|0 to 24 hours|The analysis included all patients in the modified Intent-to-Treat (mITT) population who re-randomized in the postoperative period, where time 0 was the start time of the postoperative study drug infusion, and did not have a missing baseline pain intensity score.|||units on a scale * hours||Standard Error|Mean
2685238|NCT01361568|Primary|Total Morphine Consumption in the First 24 Hours Following Postoperative Study Drug Treatment||24 hours|The primary analysis included all patients in the modified Intent-to-Treat (mITT) population who re-randomized in the postoperative period, where time 0 was the start time of the postoperative study drug infusion.|||mg||Standard Error|Mean
2685239|NCT01361464|Secondary|Number of Participants With Relapse Free Survival|Relapse-free survival is calculated from the date of documentation of complete remission/morphologic complete remission with incomplete blood count recovery (CR/CRi) until disease relapse or death from any cause.|7 months|All evaluable participants|||participants|||Number
2685240|NCT01361464|Secondary|Median 1-Year Survival Rate|Prior to the early discontinuation of the study (for not meeting the primary endpoint of at least 3 CR/CRi after 2 cycles), investigators had planned to calculate one year survival from Kaplan Meier estimates.|1 year|Evaluable participants at planned study completion date||||||
2685241|NCT01361464|Secondary|Median Overall Survival (OS)|Overall survival is calculated from the first day of R115777 treatment and lasts until the date of death recorded on the case report form (CRF).|From first treatment through follow up period, an expected average of 12 months|All evaluable participants|||months||95% Confidence Interval|Median
2685263|NCT01361178|Primary|The Primary Outcome Will be the Total Number of Days With Pneumonia.|The primary outcome for this study will be the total number of days with pneumonia. Pneumonia will be defined by the presence of both clinical and radiographic criteria: fever (temperature ≥ 38oC), cough, dyspnea, purulent expectoration and/or changes in the previous characteristics of respiratory secretions; and chest X-ray or CT scan revealing a new or progressive alveolar or interstitial infiltrate or cavitation that could not be explained by any other noninfectious cause.|Up to two years post-transplant||||Number of days|||Number
2685242|NCT01361464|Primary|Complete Remission (CR) Rate|Complete Remission (CR) rate in Acute Myelogenous Leukemia (AML) patients prospectively selected for R115777R115777 (ZARNESTRA) treatment on the basis of a 2-gene signature (RASGRP1:APTX ratio) in bone marrow aspirates. AML Complete Remission: Bone marrow aspiration - Less than 5% leukemic blasts, Auer rods not detected; Peripheral blood counts - Absolute neutrophil count >/= 1,000/mm^3, Platelet count >/= 100,000/mm^3, Leukemic blasts not present; Blood-product transfusion independence; Absence of extramedullary leukemia.|From first treatment through follow up period, an expected average of 12 months|All evaluable participants|||percentage of participants|||Number
2685243|NCT01361308|Primary|Mean Change From Baseline in Hot Flash Severity at Week 4 and Week 12|"Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot Flash Severity score per day||Standard Deviation|Mean
2685244|NCT01361308|Secondary|BMI Change From Baseline (kg/m2), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~Assessment of the effect of Brisdelle compared with placebo on body mass index."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Change from baseline BMI kg/m2||Full Range|Median
2685245|NCT01361308|Secondary|Assessment of Mood|"Mood was measured by using the Profile of Mood States (POMS) questionnaire. The Profile of Moods States (POMS) is a 65-item multi-dimensional measure that provides a method of assessing transient, fluctuating active mood states. Key areas that are measured include: tension-anxiety, anger-hostility, fatigue-inertia, depression-dejection, vigor-activity, confusion-bewilderment. Responses to questions are scored with the following numerical values: Not at all = 1, A little = 2, Moderate = 3, Quite a bit = 4, Extremely = 5. A total score for a domain was obtained by summing the responses of individual items in the domain. The total POMS score can range from 65 to 325. Each subject's total POMS score at baseline and at Week 4 and Week 12 were used to calculate the percent of participants with less disturbance in mood at Week 4 and Week 12 compared to baseline. The percent of participants with less disturbance in mood is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Percent of participants|||Number
2685246|NCT01361308|Secondary|Effect of Brisdelle (Paroxetine Mesylate) Capsules on Anxiety and Depression|"Depression & anxiety were measured by using the Hospital Anxiety & Depression Scale (HADS).~The HADS was developed to assess anxiety & depression. It is meant to differentiate symptoms of depression with those of anxiety.~Number of items: 14 (7 questions relating to anxiety; 7 questions relating to depression).~Responses are based on the relative frequency of symptoms over the past week, using a four point scale ranging from 0 (not at all) to 3 (very often indeed).~Responses are summed to provide separate scores for anxiety and depression symptomology with possible scores ranging from 0 to 21 for each scale.~The results presented below are the percentage of participants with abnormal HADS Scores for both Abnormal Anxiety & Abnormal Depression at Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Percentage of participants|||Number
2685247|NCT01361308|Secondary|Percent Responders Improvement in VMS From Baseline Using the Clinical Global Impression (CGI) Scale.|"Proportion of NRS Responders: Subject's overall improvement in VMS from Baseline was assessed using the Numerical Rating Scale (NRS)~The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.~Responders: Subjects Achieving a Score of Very Much Improved Or Much Improved Or Minimally Improved.~Non Responders: Subjects with a Score of No Change Or Minimally Worse Or Much Worse Or Very Much Worse."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||percentage of participants|||Number
2685248|NCT01361308|Secondary|Effect of Paroxetine Mesylate Capsules on Percent Improvement of Hot Flash Interference From Baseline at Week 4 and Week 12, Hot Flash Related Daily Interference Scale (HFRDIS)|"Interference of hot flashes was measured by using the hot flash-related daily interference scale (HFRDIS). The HFRDIS is a 10-item scale that measures the degree to which hot flashes interfere with 9 daily activities and the tenth item measures the degree to which hot flashes interfere with each of the other items. Subjects can score for each item on a scale from 0 to 10 where 0 = Do not interfere and a score of 10 = Completely interferes.~The measure being reported below is percentage of responders who had an improvement in HFRDIS score at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the HFRDIS score. An improvement is defined as a score ≤3 on each question."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Percent of participants|||Number
2685249|NCT01361308|Secondary|Change From Baseline in Arizona Sexual Experience Scale (ASEX, Week 4 and Week 12) Total Score|"The Arizona Sexual Experiences Scale (ASEX) is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.~The sum of the scores for all 5 items was calculated at Week 4 and Week 12. The results presented below are change from baseline at Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||units on a scale||Standard Deviation|Mean
2685250|NCT01361308|Secondary|Percent Daytime and Nighttime Responders, Numerical Rating Scale (NRS)|"Subject's overall improvement in VMS from Baseline assessed using the Numerical Rating Scale (NRS) The NRS is measured on a scale of 0 to 10 on how bothered the subject was by her VMS (0=not bothered at all and 10=very much bothered).~The measure being reported below is percentage of responders who had an improvement in NRSscore at Week 4 and Week 12 compared to baseline. A responder is defined as a subject who had an improvement in the NRS score. An improvement is defined as a score ≤5 on each question."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||percentage of participants|||Number
2685251|NCT01361308|Secondary|Percentage of Patient Global Improvement (PGI) Scale Responders (%)|"Percentage of PGI Responders: Subject's overall improvement in VMS from baseline assessed using the Patient Global Improvement (PGI) scale. Responders: Subjects Achieving a Score of Very Much Better Or Much Better Or A Little Better.~Non Responders: Subjects with a Score of No Change Or A Little Worse Or Much Worse Or Very Much Worse.~Patient Global Improvement (PGI) scale is described below:~Compared to before starting study medication, how would you describe your hot flushes now? 0 = Not assessed~= Very much better~= Much better~= A little better~= No change~= A little worse~= Much worse~= Very much worse"|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||percentage of participants|||Number
2685252|NCT01361308|Secondary|Percentage of Responders|Participants reported the number of hot flashes using an electronic diary. Participants who hd a ≥50% reduction in hot flash frequency were defined as responders. The percent of responders is presented below.|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||percentage of participants|||Number
2685253|NCT01361308|Secondary|Change From Baseline in Greene Climacteric Scale (GCS) at Week 4 and Week 12, Total Score, Median|"The Greene Climacteric Scale (GCS) was used for this measurement. The scale has 21 questions and measures symptoms in 4 areas; these are psychological (anxiety and depression), physical, vasomotor, and libido.~The severity of the symptom was scored as: 0=none, 1=mild, 2=moderate, and 3=severe. Anxiety was determined by using the sum of scores 1 to 6, and depression was determined by using the sum of scores 7 to 11. Physical aspects were determined by using the sum of scores 12 to 18; vasomotor aspects were determined by using the sum of scores 19 to 20; and libido was determined by using the score for question 21.~The total GCS score ranges from 0 to 63 which is the sum of all the scores for the 21-symptom assessment questions in this scale. Each subject's total GCS score at baseline and at Week 4 and Week 12 were used to calculate change from baseline in these symptoms. The change from baseline is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||units on a scale||Full Range|Median
2685254|NCT01361308|Secondary|Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.~Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot Flash Severity scores per week||Full Range|Median
2685264|NCT01361126|Secondary|Breakthrough Bleeding Events|Number of breakthrough bleeding events (spontaneous bleeding events) requiring treatment per subject in subjects receiving prophylactic treatment regimen with rIX-FP|Week 9 to approximately Week 20|Per protocol population|||Events per subject||Standard Deviation|Mean
2685265|NCT01361126|Secondary|Clearance of a Single Dose of rIX-FP||Pre-dose and up to 14 days after rIX-FP infusion|PK population|||mL/h/kg||Geometric Coefficient of Variation|Geometric Mean
2685266|NCT01361126|Secondary|Incremental Recovery of rIX-FP at 30 Minutes Following Infusion of rIX-FP|Incremental recovery (IU/mL/IU/kg) is defined as FIX activity (IU/mL) obtained 30 minutes following infusion, per dose of (IU/kg) infusion. FIX activity was measured at a central laboratory using validated one-stage clotting method.|30 minutes after infusion|PK population|||IU/dL/IU/kg||Geometric Coefficient of Variation|Geometric Mean
2685267|NCT01361126|Secondary|Half-life (t1/2) of a Single Dose of rIX-FP||Pre-dose and up to 14 days after infusion|PK population|||hours||Geometric Coefficient of Variation|Geometric Mean
2685255|NCT01361308|Secondary|Change in Severity of Moderate to Severe Hot Flashes From Baseline (BMI <32 kg/m2, At Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI <32 kg/m2 subgroup, the mean weekly reduction in the severity of moderate to severe hot flashes from Baseline was calculated at Week 4 and Week 12.~Subjects recorded the number of hot flashes per week using an electronic diary. Severity score for hot flashes for each subject was calculated as the sum of 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of moderate and severe hot flashes.~Weekly Severity Score = (2•Fm +3•FS)/(Fm + FS) Daily Severity Score = {(2•F) m +3•FS)/(Fm + FS)}/7 Where, Fm= Frequency of Moderate Hot Flashes Fs = Frequency of Severe Hot Flashes The calculated severity score is reported below."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot Flash Severity scores per week||Full Range|Median
2685256|NCT01361308|Secondary|Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI ≥32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI ≥32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot flashes per week||Full Range|Median
2685257|NCT01361308|Secondary|Change in Frequency of Moderate to Severe Hot Flashes Frequency From Baseline (BMI <32 kg/m2, Week 4 and Week 12), Median|"Subjects were weighed at each clinic visit and reported the number of hot flashes using an electronic diary.~For the BMI <32 kg/m2 subgroup, the mean weekly reduction in frequency of moderate to severe hot flashes from Baseline was calculated for Week 4 and Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot flashes per week||Full Range|Median
2685258|NCT01361308|Secondary|Change From Baseline in Total Number of Awakenings Due to Hot Flashes, Median|"Participants completed a electronic diary to report nightime awakenings. Subjects took study drug once daily at bedtime and they were instructed to complete daily hot flash and sleep diaries to record the number of hot flashes daily, the severity of each episode of hot flash and total number of awakenings due to hot flashes.~The diary data was used to evaluate and compare the treatment groups, on the change from baseline to Week 4 and Week 12, in the total number of awakenings due to hot flashes. The total number of awakenings due to hot flashes in the run-in period was used as baseline."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Nightime awakenings||Full Range|Median
2685259|NCT01361308|Secondary|Clinical Meaningfulness Anchored to Patient Global Improvement (PGI-I) (%)|"A patient improvement scale questionnaire was used during participant visits.~The clinical meaningfulness of the observed treatment effect was demonstrated by performing the following analysis:~Subjects were categorized in to 2 groups (satisfied and unsatisfied). Based on a 7 point patient global impression (PGI) questionnaire which assesses the subject improvement in VMS. Subjects were considered satisfied with their treatment if their response to the question Compared to before starting the study medication, how would you describe your hot flushes now? is 'Very much better' (1) or 'Much better' (2) or 'A little better' (3) and will be considered unsatisfied if their response to the same question is 'No change' (4) or 'A little worse' (5) or 'Much worse' (6) or 'Very much worse' (7). Receiver Operator Curve (ROC) analysis was performed on the combined data.~Subjects who were satisfied with their treatment were considered to have a treatment effect with clinical meaningfulness"|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Percentage of satisfied participants|||Number
2685260|NCT01361308|Primary|Mean Change in Frequency of Moderate to Severe VMS From Baseline at Week 4 and Week 12.|"Subjects recorded the number of hot flashes per week using an electronic diary. The results reported are not hot flashes per week.~The results reported are:~Mean Baseline frequency of moderate to severe VMS~Mean change in frequency of moderate to severe VMS from baseline to Week 4~Mean change in frequency of moderate to severe VMS from baseline to Week 12."|Week 4 and Week 12|The outcome data presented for these measurements were obtained using a scale questionnaire. Data were analyzed only from participants who completed and turned in the completed questionnaire. Therefore, the number of participants analyzed is not consistent with numbers provided in any of the rows in the participant flow module.|||Hot flash per day||Standard Deviation|Mean
2685261|NCT01361217|Secondary|AUC of Dextromethorphan, Midazolam and Omeprazole in the Presence of Fluoxetine|Our secondary outcome measure will be the interaction between fluoxetine and each CYP evaluated in the cocktail. A 50% increase in the AUC of caffeine (CYP1A2), dextromethorphan (CYP2D6), omeprazole (CYP2C19) or midazolam (CYP3A4) between treatment and control days is considered clinically significant. The interaction of fluoxetine with caffeine (CYP1A2) will be considered as a negative control for the study. These AUCs will be measured on study day 1 (control day) and study day 18|The secondary outcome will be assessed within 2 months after the last subject is enrolled or at 2 years from the start of study enrollment, which ever is sooner.||||nmol*hr/L||Standard Deviation|Mean
2685262|NCT01361217|Primary|Lovastatin AUC in the Presence of Fluoxetine|Our primary outcome measure will be the interaction of fluoxetine with CYP3A4. A 50% increase in the AUC for lovastatin plus hydroxy-lovastatin acid (the active form of lovastatin) between treatment day 14 (study day 20) and control days (study day 2) is considered clinically significant.|The primary outcome will be assessed within 2 months after the last subject is enrolled or at 2 years from the start of study enrollment, which ever is sooner.||||nmol*hr/L||Standard Deviation|Mean
2685268|NCT01361126|Secondary|Area Under the Curve to the Last Sample With Quantifiable Drug Concentration (AUC0-t) After a Single Dose of rIX-FP|The plasma concentrations of rIX-FP were measured as FIX activity using a validated, 1-stage assay in a central laboratory for a quantification range from 0.25 to 150% (or 0.25 IU/dL to 150 IU/dL). The PK population comprised all subjects who received at least 1 dose of rIX-FP and for whom a sufficient number of analyzable PK samples had been obtained in order to permit the evaluation of the PK profile of rIX-FP, and who did not receive a dose of rIX-FP or any other FIX product for the treatment of a bleed during the PK sampling period.|Pre-dose and up to 14 days after rIX-FP infusion.|PK population|||h*IU/dL||Geometric Coefficient of Variation|Geometric Mean
2685269|NCT01361126|Primary|Number of Subjects Who Developed Antibodies to rIX-FP|Antibodies against rIX-FP were detected using a direct binding enzyme-linked immunosorbent assay (ELISA).|Pre-dose, Day 10 and Weeks 4, 12, and 20|Safety Population|||participants|||Number
2685270|NCT01361126|Primary|Number of Subjects With Inhibitors Against Factor IX (FIX)|The presence of inhibitors against FIX was assessed by the central laboratory by a FIX potency assay. To quantify anti-FIX neutralizing antibodies, the Bethesda assay with the Nijmegen modification was used, and the results expressed as Bethesda Units per mL (BU/mL). A positive inhibitor test is >=0.6 BU/mL.|Baseline, Day 10 and Weeks 4, 12 and 20|Safety Population|||participants|||Number
2685271|NCT01361126|Primary|Number of Subjects With Treatment-related Adverse Events|The causal relationship of each adverse event to rIX-FP was assessed by the Investigator.|Approximately 20 weeks|Safety Population|||participants|||Number
2685272|NCT01361113|Secondary|Number of Participants With Adverse Events Related to Treatment.|"Identify any safety issues in subjects treated with pazopanib, neoadjuvantly, followed by nephrectomy. Number of patients that had adverse events reported that had an attribution of; possible, probable, or definite that are graded a 3 or higher according to Common Terminology Criteria for Adverse Events (CTCAE v4.0).~Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.~Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.~Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to adverse event."|9 weeks||||Participants|||Count of Participants
2685273|NCT01361113|Secondary|Number of Participants Who Needed an Altered Surgical Approach After Treatment With Pazopanib|Determine if neoadjuvant treatment with pazopanib alters the planned surgical approach of the urologist, per documented radiographic (CT) response.|14 weeks||||Participants|||Count of Participants
2685274|NCT01361113|Secondary|Recurrence Free Survival (RFS)|Estimate recurrence free survival (RFS) following neoadjuvant treatment with pazopanib followed by nephrectomy, specifically reporting the 1 year and 2 year rate estimates with their 95% confidence intervals.|2 years||||percentage of Participants||95% Confidence Interval|Number
2685275|NCT01361113|Primary|Response Rate|"Determine the objective response rate (CR+PR) using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 at 8 weeks after neoadjuvant treatment with pazopanib in patients with locally advanced renal cell carcinoma.~Evaluation of Target Lesions using RECIST 1.1 Criteria:~Complete response (CR)−Disappearance of all target lesions. Any pathological lymph node (LN) target or no must have decreased in short axis to <10mm.~Partial response (PR)−At least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD."|8 weeks after neoadjuvant treatment||||Participants|||Count of Participants
2685276|NCT01361048|Secondary|Tolerability of the Study Product as Measured by Participant Self-report|Number of participants with any side effects|day 12-15 day 30-35||||Participants|||Count of Participants
2685277|NCT01361048|Primary|Percentage of Participants Cured of Vaginal Trichmonas|percentage of participants achieving microbiological cure of trichomonas|day 12-15||||percentage of participants|||Number
2685278|NCT01361009|Secondary|The Dosage Related Information of Pramipexole at the End of Study|At the end of study, the distribution of patients in 3 pramipexole dosage categories.|12 weeks|There were 2017 patients in SAS set|||percentage of patients|||Number
2685279|NCT01361009|Secondary|The Dosage Related Information of Pramipexole at Baseline|At enrollment, the distribution of patients in 3 pramipexole dosage categories.|baseline|There were 2017 patients in SAS set.|||percentage of patients|||Number
2685280|NCT01361009|Secondary|Patient Global Impression(PGI) at Visit 1(Baseline) and Visit 3(at the End of Study)|Patient Global Impression (PGI) scale, ranging from 1 (excellent) to 7 (extremely poor), including 1(excellent), 2(very good), 3(good), 4(no change), 5(poor), 6(very poor) and 7(extremely poor).|Baseline (Visit 1) and 12 weeks (Visit 3)|There were 1891 patients in full analysis set(FAS). FAS includes all patients who fulfilled the inclusion criteria and exclusion criteria, without missing PGI values at visit 1 and visit 3. In the recruited 2017 patients, 116 patients didn't fully meet the inclusion or exclusion criteria and 10 patients missed PGI data at visit 1 or visit 3.|||unit on a scale||Standard Deviation|Mean
2685281|NCT01361009|Primary|Incidence of AE/SAE|The percentage of adverse events or serious adverse events occurring under Pramipexole mono- or combination therapy with other medication in this study.|12 weeks|There were 2017 patients in the safety analysis set (SAS). SAS includes the patients who took drug at least once and had safety data. In this study, 2017 patients were recruited, who have been using pramipexole before the enrollment.|||Percentage of participants|||Number
2685282|NCT01360996|Secondary|Oral Disposition Index|Post-treatment insulin secretion-sensitivity index (ISSI) calculated from the oral glucose tolerance test (OGTT). A higher value indicate improved carbohydrate metabolism|24 weeks||||calculated index||Standard Deviation|Mean
2685283|NCT01360996|Secondary|Adrenal Androgen DHEAS|Post-treatment levels of adrenal androgen DHEAS|24 weeks||||micromol/L||Standard Deviation|Mean
2685284|NCT01360996|Secondary|Menstrual Cycle Regularity|Post treatment menstrual frequency over 24 weeks normalized to number of menses per year ..|24 weeks||||number of cycles annually||Standard Deviation|Mean
2685285|NCT01360996|Secondary|Biochemical Indicator of B-vitamin Status|Post-treatment in folate concentrations after 24 weeks of treatment|24 weeks||||Folate in nmol/l||Standard Deviation|Mean
2685286|NCT01360996|Secondary|Post Therapy BMI.|Post-treatment body mass index at 24 weeks|24 weeks||||kg/m2||Standard Deviation|Mean
2685287|NCT01360996|Secondary|Cardiometabolic Measures|Values represent blood pressure at 24 weeks.|24 weeks||||mmHg||Standard Deviation|Mean
2685288|NCT01360996|Primary|Biochemical Assessment of Hyperandrogenism|"The primary outcome measure is post-treatment Free Androgen Index(FAI) which is expressed in units.~FAI is calculated by taking the testosterone concentration (in nmol/l) and dividing by concentration of sex hormone binding globulin (SHBG in nmol/L)and multiplying by 100"|24 weeks||||Index||Standard Deviation|Mean
2685289|NCT01360866|Secondary|Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score|"The IDS-SR was a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of MDD. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the best rating and 3 being the worst rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 (best) to 84 (worst).~Under item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. If the number of items recorded is at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place."|From screening to week 52/early termination|Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.|||units on a scale||Standard Deviation|Mean
2685290|NCT01360866|Secondary|Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score|"The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on regular life responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains with scores from 0 = not at all, to 10 = extremely.~Scores of 5 and above were associated with significant functional impairment."|From screening to week 52/early termination|Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.|||units on a scale||Standard Deviation|Mean
2685291|NCT01360866|Secondary|Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score|The efficacy of trial treatment was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant's condition at screening. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse.|From screening to week 52/early termination|Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.|||units on a scale||Standard Deviation|Mean
2685292|NCT01360866|Secondary|Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score|"The severity of illness for each participant was rated using the CGI-S . On the basis of the investigator answer to the question: Considering your total clinical experience with this particular population, how mentally ill was the participant at that time? Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|From screening to week 52/early termination|Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs and had at least one post-baseline efficacy evaluation of CGI-S.|||units on a scale||Standard Deviation|Mean
2685293|NCT01360866|Primary|Adverse Events (AEs) - All Participants|To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole.|From screening to week 52/early termination|Participants who received at least one dose of open-label brexpiprazole as adjunctive therapy to one of the allowed ADTs.|||Participants|||Count of Participants
2685294|NCT01360840|Other Pre-specified|To Explore the Relationship Between Number and/or Changes of Numbers of Biomarker and the Clinical Outcome||From the date of randomization up to data cut-off date (30 April 2013), assessed up to 2 years|Data for this outcome measure was presented graphically as per planned analysis but not statistically summarized.||||||
2685295|NCT01360840|Secondary|Pharmacokinetic Parameter: Volume of Distribution of EMD 525797 After the First Dose (V) and in Steady State After the Fifth Dose (Vss) of Intravenous Infusion|The apparent volume of distribution during the terminal phase following intravenous administration (V). The estimate of the apparent volume of distribution at steady state following intravenous administration (Vss).|Cycle 1 (Week 1) and cycle 5 (Week 13): Day 1: pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 96, 168, 336, and 504 hours after start of infusion; Cycles 3 and 4 (Weeks 7 and 10), Day 1: pre-dose; Cycle 7 (Week 19), Day 1: pre-dose and EOI|"PKA included all the randomized subjects who received at least the first dose of the trial drug and provided sufficient data for a concentration time profile for EMD 525797. n signifies the number of subjects evaluable for each category in the evaluated group, respectively."|||liter||Standard Deviation|Mean
2685296|NCT01360840|Secondary|Pharmacokinetic Parameter: Clearance of Intravenously Administered EMD 525797 After First Dose (CL) and Clearance in Steady State of EMD52597 After Fifth Dose (CLss)|The apparent total body clearance of drug following intravenous administration (CL); The apparent total body clearance of drug at steady state following intravenous administration (CLss).|Cycle 1 (Week 1) and cycle 5 (Week 13): Day 1: pre-dose, End of Infusion (EOI), 4, 8, 24, 48, 96, 168, 336, and 504 hours after start of infusion; Cycles 3 and 4 (Weeks 7 and 10), Day 1: pre-dose; Cycle 7 (Week 19), Day 1: pre-dose and EOI|"Pharmacokinetic Analysis Set (PKA) included all the randomized subjects who received at least the first dose of the trial drug and provided sufficient data for a concentration time profile for EMD 525797. n signifies the number of subjects evaluable for each category in the evaluated group, respectively."|||Liter per hour||Standard Deviation|Mean
2685345|NCT01360632|Secondary|Mean CGI-I Score at Each Trial Week Visit in Phase B for the Efficacy Sample Per Final Protocol|The efficacy of study medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.|Weeks 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Deviation|Mean
2685297|NCT01360840|Secondary|Number of Subjects With Any Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, and TEAEs Leading to Discontinuation|An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious adverse event was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as those AEs that started between first dose of study drug and up to 50 days after last dose.|From the first dose of study drug administration until 50 days after the last dose of study drug administration or until cut-off date (30 April 2013), assessed up to 2 years|The Safety analysis set included all the randomized subjects who received at least 1 dose of planned trial treatment and had at least one safety assessment following the trial treatment.|||Subjects|||Number
2685298|NCT01360840|Secondary|Overall Minimum Percentage Change From Previous Time Point in Circulating Tumor Cells (CTC)||Cycle 1, Day 1 (Week 1): pre-dose, Cycle 3, Day 1 (Week 7): pre-dose, and Cycle 5, Day 1 (Week 13): pre-dose|ITT analysis set included all the subjects who were randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
2685299|NCT01360840|Secondary|Minimum Percentage Change From Baseline in the Number of Circulating Tumor Cells (CTCs)||Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
2685300|NCT01360840|Secondary|Minimum Percentage Change From Baseline in PSA Serum Concentration||Baseline, up to data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.|||Percent change||Standard Deviation|Mean
2685301|NCT01360840|Secondary|Number of Subjects With Presence of Prostate Specific Antigen (PSA) Response|PSA response was defined as a decrease greater than 50 percent (%) in PSA value from baseline for 2 consecutive evaluations greater than or equal to (>=) 3 Weeks apart.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.|||Subjects|||Number
2685302|NCT01360840|Secondary|Number of Subjects With Presence of Skeletal Related Events|Presence of skeletal related events was defined as cord compression or fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms at the investigator discretion. Non-radiological events, including emergency bone irradiation and surgery, were not investigated.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study.|||Subjects|||Number
2685303|NCT01360840|Secondary|Bone and Soft Tissue Lesions Composite Tumor Response|Bone and soft tissue lesions composite tumor response was defined as the presence of both a confirmed CR or PR, documented by CT scans, and a DC in bone lesions, documented by bone scintigraphy. CR was defined as disappearance of all target and non-target lesions and PR was defined as at least 30% decrease in the sum of the longest diameter of target lesions and non-complete response/non-progressive disease in non-target lesions. Presence of DC in bone lesions was defined as the appearance of less than 2 new bone lesions.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study.|||Subjects|||Number
2685304|NCT01360840|Secondary|Number of Subjects With Presence of DC in Bone Lesions|Presence of DC in bone lesions was defined as the appearance of less than 2 new bone lesions, documented by bone scintigraphy.|At Weeks 13, 19 and 25|ITT analysis set included all the subjects randomized in the study.|||Subjects|||Number
2685305|NCT01360840|Secondary|Number of Subjects With New Bone Lesions Compared to Baseline|New bone lesions were evaluated by bone scintigraphy for subjects with bone lesions at baseline.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects randomized in the study. “N” signifies the total number of subjects evaluable for this outcome measure.|||Subjects|||Number
2685306|NCT01360840|Secondary|Number of Subjects With Presence of Tumor Response and Disease Control (DC) in Soft Tissue Lesions|Presence of tumor response in soft tissue lesions was defined as the presence of at least 1 confirmed complete response (CR) or confirmed partial response (PR) in soft tissue lesions, documented by computed tomography (CT) scans. Presence of DC in soft tissue lesions was defined as the presence of at least 1 confirmed CR or confirmed PR or stable disease (SD) lasting at least 12 weeks after randomization. Tumor response assessments were based on RECIST v1.0 modified according to the PCWG-2. The response was evaluated for subjects with measurable disease at baseline. According to RECIST v1.0, CR=disappearance of all target and non-target lesions; PR=at least 30% decrease in the sum of the longest diameter of target lesions and non-complete response/non-progressive disease in non-target lesions.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|"ITT analysis set included all the subjects who were randomized in the study. N signifies the total number of subjects evaluable for this outcome measure."|||Subjects|||Number
2685307|NCT01360840|Secondary|Time to Tumor Progression|Time to tumor progression was defined as the time from the date of randomization to the date of ORDP. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy, which had to be confirmed by bone scintigraphy 6 weeks later if subjects remained asymptomatic or mildly symptomatic. Assessments were to be based on RECIST v1.0 modified according to PCWG-2; Soft-tissue lesion progression assessed with CT scans according to RECIST v1.0 modified as per PCWG-2; Presence of skeletal events defined as cord compression or fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms, based on the investigator's discretion; Non-radiological events, including emergency bone irradiation and surgery, were not investigated.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study.|||months||95% Confidence Interval|Median
2685308|NCT01360840|Secondary|Overall Survival|Overall Survival was defined as the time from the date of randomization to the date of death from any cause.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|ITT analysis set included all the subjects who were randomized in the study.|||months||95% Confidence Interval|Median
2685309|NCT01360840|Primary|Progression Free Survival (PFS) Time|PFS was defined as time from randomization until the first documented sign of objective radiographic disease progression (ORDP) or death from any cause. Death was considered as an event only if it was reported within 12 weeks after last tumor assessment without progression. ORDP was defined as: Bone lesion progression (2 or more new bone lesions compared to baseline) assessed with bone scintigraphy. Assessment was based on Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) modified as per Prostate Cancer Working Group 2 (PCWG-2); Soft-tissue lesion progression assessed with CT scans according to RECIST v1.0 modified as per PCWG-2; Presence of skeletal events defined as cord compression/fracture documented via a scheduled or unscheduled radiographic assessment triggered by increased pain or other signs and/or symptoms, based on the investigator's discretion; Non-radiological events, including emergency bone irradiation and surgery, were not investigated.|Time from randomization until data cut-off date (30 April 2013), assessed up to 2 years|Intention-to-treat (ITT) analysis set included all the subjects who were randomized in the study.|||months||95% Confidence Interval|Median
2685310|NCT01360762|Secondary|Number of Required Additional Interventions|The number of required additional clinical interventions/therapeutic procedures|30 months||||number of events|||Number
2685311|NCT01360762|Secondary|Number of Treatment Discontinuations and Interruptions|Number of treatment discontinuations and interruptions/missed doses.|30 months||||number of events|||Number
2685312|NCT01360762|Secondary|Number of Participants With Adverse Events|During the first year of pentamidine administration for prophylaxis: participants with any drug-related non-serious adverse events (with drug-related defined as possibly, probably or definitely related to primary therapy following physicians assessment) as well as any serious adverse events (drug-related or not)|1 year||||Participants|||Count of Participants
2685313|NCT01360762|Primary|Number of Participants With Serious Adverse Events (SAEs)|Number of patients with SAEs which are possibly, probably or definitely drug-related following clinician's assessment or that lead to permanent drug discontinuations during the first year of pentamidine administration|1 year||||Participants|||Count of Participants
2685314|NCT01360762|Primary|Probability of Relapse-free Survival|Probability of relapse-free survival up to one year after the start of the intervention (PSP) (at month 6 and month 12)|up to 1 year after the start of the intervention (PSP)||||percentage probability||95% Confidence Interval|Number
2685315|NCT01360645|Secondary|Percentage of Participants With CGI-I Scale Response Rate at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample Per the Final Protocol.|CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Percentage of participants|||Number
2685316|NCT01360645|Secondary|Percentage of Participants With CGI-I Scale Response Rate at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample.|CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Percentage of participants|||Number
2685317|NCT01360645|Secondary|Percentage of Participants With MADRS Remission at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample Per the Final Protocol.|MADRS remission was defined as </=10 and >/=50% reduction in MADRS total score from end of Phase A (Week 8).|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Percentage of participants|||Number
2685318|NCT01360645|Secondary|Percentage of Participants With MADRS Remission at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample.|MADRS remission was defined as </=10 and >/=50% reduction in MADRS total score from end of Phase A (Week 8).|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Percentage of participants|||Number
2685319|NCT01360645|Secondary|Percentage of Participants With MADRS Response at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample Per the Final Protocol.|The MADRS response was defined as >/=50% reduction in MADRS total score from end of Phase A (Week 8).|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Percentage of participants|||Number
2685320|NCT01360645|Secondary|Percentage of Participants With MADRS Response at Week 14 Relative to Baseline (End of Phase A [Week 8]) for the Efficacy Sample.|The MADRS response was defined as >/=50% reduction in MADRS total score from end of Phase A (Week 8).|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Percentage of participants|||Number
2685321|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in HAM-A Rating Scale Total Score for the Efficacy Sample Per the Final Protocol.|"The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the best rating and 4 is the worst rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher scores indicating worse anxiety symptoms."|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Units on a scale||Standard Error|Least Squares Mean
2685322|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in Hamilton Anxiety (HAM-A) Rating Scale Total Score for the Efficacy Sample|"The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the best rating and 4 is the worst rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher scores indicating worse anxiety symptoms."|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Units on a scale||Standard Error|Least Squares Mean
2685323|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in HAM-D Rating Scale Total Score for the Efficacy Sample Per the Final Protocol.|"The HAM-D (17-Item) consists of 17 items. Eight items are rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the best rating and the highest score (2 or 4) is the worst rating. The sum of the scores from the first 17 items; 0-7 =Normal; 8-13 =mild depression; 14-18 =moderate depression; 19-22 =severe depression; ≥23 =very severe depression. The total score ranges from 0 to 52, with higher score indicating worse depressive symptoms."|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at Phase B visit, if no observation was recorded, data was carried forward from previous visit.|||Units on a scale||Standard Error|Least Squares Mean
2685324|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in Hamilton Depression (HAM-D) Rating Scale Total Score for the Efficacy Sample.|"The HAM-D (17-Item) consists of 17 items. Eight items are rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the best rating and the highest score (2 or 4) is the worst rating. The sum of the scores from the first 17 items; 0-7 =Normal; 8-13 =mild depression; 14-18 =moderate depression; 19-22 =severe depression; ≥23 =very severe depression. The total score ranges from 0 to 52, with higher score indicating worse depressive symptoms."|Baseline and Week 14|Efficacy Sample comprised all participants in Safety Sample who had end of Phase A value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The Last-observation-carried-forward (LOCF) data set included data recorded at Phase B visit, if no observation was recorded, data was carried forward from previous visit.|||Units on a scale||Standard Error|Least Squares Mean
2685325|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Per the Final Protocol.|The SDS is a self-rated instrument used to measure the effect of the patient's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 11 and 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
2685326|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample.|The SDS is a self-rated instrument used to measure the effect of the patient's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 11 and 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
2685327|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in the IDS-SR Total Score for the Efficacy Sample Per the Final Protocol.|"The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the best rating and 3 being the worst rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. Should items 11 and 12 be rated both, then the maximum of the two scores will be used. The same approach will be used for handling items 13 and 14.~The IDS-SR total score is the sum of ratings of 28 item scores. The possible IDS-SR total score ranges from 0 to 84."|Week 9, 10, 11, 12, 13, and 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
2685336|NCT01360645|Secondary|Mean Change From Baseline (End of Phase A [Week 8]) to Week 14 in Sheehan Disability Scale (SDS) Score for the Efficacy Sample.|The SDS is a self-rated instrument used to measure the effect of the patient's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
2685328|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in the Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score for the Efficacy Sample.|"The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the best rating and 3 being the worst rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. Should items 11 and 12 be rated both, then the maximum of the two scores will be used. The same approach will be used for handling items 13 and 14.~The IDS-SR total score is the sum of ratings of 28 item scores. The possible IDS-SR total score ranges from 0 to 84."|Week 9, 10, 11, 12, 13, and 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
2685329|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in CGI-S Scale Score for the Efficacy Sample Per the Final Protocol.|Items on CGI-S scale are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) will be set to missing. The CGI-S is therefore a 7-point scale from 1 through 7.|Week 9, 10, 11, 12, 13, and 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
2685330|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score for the Efficacy Sample.|Items on CGI-S scale are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) will be set to missing. The CGI-S is therefore a 7-point scale from 1 through 7.|Week 9, 10, 11, 12, 13, and 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
2685331|NCT01360645|Secondary|Mean CGI-I Scale Score (End of Phase A [Week 8]) to Week 14 by Trial Week for the Efficacy Sample Per the Final Protocol.|The items on CGI-I scale are: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. The CGI-I was measured in related to Baseline (Week 8).|Week 9, 10, 11, 12, 13, and 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Units on a scale||Standard Deviation|Mean
2685332|NCT01360645|Secondary|Mean Clinical Global Impression-Improvement (CGI-I) Scale Score (End of Phase A [Week 8]) to Week 14 by Trial Week for the Efficacy Sample.|The items on CGI-I scale are: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. The CGI-I was measured in related to Baseline (Week 8).|Week 9, 10, 11, 12, 13, and 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B. The LOCF data set included data recorded at a Phase B visit, if no observation was recorded, data was carried forward from the previous visit.|||Units on a scale||Standard Deviation|Mean
2685333|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score by Trial Week for the Efficacy Sample Per the Final Protocol.|"The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place."|Week 9, 10, 11, 12, and 13|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
2685334|NCT01360645|Secondary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score by Trial Week for the Efficacy Sample.|"The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place."|Week 9, 10, 11, 12, and 13|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
2685335|NCT01360645|Secondary|Mean Change From Baseline (End of Phase A [Week 8]) to Week 14 in SDS Score for the Efficacy Sample Per the Final Protocol|The SDS is a self-rated instrument used to measure the effect of the patient's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Baseline and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
2685684|NCT01357720|Primary|Seroprotection Rate: Anti-hepatitis B Surface Antibodies|Percentage of subjects with an anti-hepatitis B surface antibody titer ≥10 IU/L (i.e. seroprotection rate)|1 month after the third vaccination|Available observations at Visit 4|||percentage of subjects||95% Confidence Interval|Number
2685337|NCT01360645|Primary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score for the Efficacy Sample Per the Final Protocol.|"The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place."|Baseline and Week 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
2685338|NCT01360645|Primary|Change From Baseline (End of Phase A [Week 8]) to Week 14 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score for the Efficacy Sample.|"The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place."|Baseline and Week 14|The Efficacy Sample comprised of all participants in the Safety Sample who had an end of Phase A (i.e, Week 8) value and at least one post-randomization efficacy evaluation for MADRS total score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
2685339|NCT01360632|Secondary|Percentage of Participants With a CGI-I Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Per Final Protocol|A CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Weeks, 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Percentage of participants|||Number
2685340|NCT01360632|Secondary|Percentage of Participants With a CGI-I Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Set|A CGI-I response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved).|Weeks 8, 9, 10, 11, 12, 13 and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Percentage of participants|||Number
2685341|NCT01360632|Secondary|Percentage of Participants With a MADRS Remission During Phase B Relative to the End of Phase A (Week 8) for the Efficacy Sample Per Final Protocol|"MADRS remission was defined as a < or equal to 10 and > or equal to 50% reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome."|Weeks 8, 9, 10, 11, 12, 13 and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Percentage of participants|||Number
2685342|NCT01360632|Secondary|Percentage of Participants With a MADRS Remission During Phase B Relative to the End of Phase A (Week 8) for the Efficacy Sample Set|"MADRS remission was defined as a < or equal to 10 and > or equal to 50% reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome."|Weeks 8, 9, 10, 11, 12, 13 and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Percentage of participants|||Number
2685343|NCT01360632|Secondary|Percentage of Participants With a MADRS Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Per Final Protocol|"MADRS response was defined as >=50 percent reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome."|Weeks 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Percentage of participants|||Number
2685344|NCT01360632|Secondary|Percentage of Participants With a MADRS Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Set|"MADRS response was defined as >=50 percent reduction in MADRS Total Score from end of Phase A (Week 8). The MADRS was utilized as an efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome."|Weeks 8, 9, 10, 11, 12, 13, and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Percentage of participants|||Number
2695812|NCT01275339|Secondary|Change in Novel Echocardiographic Indices of Diastolic Function|LV stiffness, viscoelasticity, and a load independent index of diastolic filling|12 weeks and 6 months|||||||
2685346|NCT01360632|Secondary|Mean CGI-I Score at Each Trial Week Visit in Phase B for the Efficacy Sample Set|"The efficacy of study medication was rated for each participant using the CGI-I. The study physician would rate the participant's total improvement whether or not it is due entirely to drug treatment.~Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse."|Week 8 to Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Deviation|Mean
2685347|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in HAM-A Total for the Efficacy Sample Per Final Protocol|"The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the best rating and 4 is the worst rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher score indicating worse anxiety symptoms."|Baseline and Week 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
2685348|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Anxiety Rating Scale (HAM-A) Total Score for the Efficacy Sample Set|"The HAM-A is utilized for the evaluation of anxiety symptoms. The HAM-A consists of 14 items. Each item is rated on a 0 to 4 scale. For all of these items, 0 is the best rating and 4 is the worst rating. If no item scores are missing, then the HAM-A total score is the sum of all 14 item scores. The possible total scores are from 0 to 56, with higher scores indicating worse anxiety symptoms."|Baseline and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
2685349|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in HAM-D17 Total Score for the Efficacy Sample Set Per Final Protocol|"The HAM-D17 was utilized as a secondary assessment of a participants level of depression. The HAM-D (17-Item) consisted of 17 items. Eight items were rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) were rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 was the best rating and the highest score (2 or 4) was the worst rating. The possible total scores were from 0 to 52, with higher score indicating more severe depression."|Baseline and Week 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
2685350|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) Hamilton Depression Scale 17 Item Version (HAM)-D17 Total Score for the Efficacy Sample Set|"The HAM-D17 was utilized as a secondary assessment of a participants level of depression. The HAM-D (17-Item) consisted of 17 items. Eight items were rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) were rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 was the best rating and the highest score (2 or 4) was the worst rating. The possible total scores were from 0 to 52, with higher scores indicating more severe depression."|Baseline and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
2685351|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in IDS-SR Total Score for the Efficacy Sample Per Final Protocol|"The IDS-SR was a 30-item self-report measured to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the best rating and 3 being the worst rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items were not included in the calculation of the total score. The IDSSR Total Score was the sum of ratings of 28 item scores. The possible IDSSR Total Score ranged from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items were recorded. If the number of items recorded was at least 23 and at most 27, the IDS-SR Total Score was the mean of the recorded items multiplied by 28, and was then rounded off to the first decimal place."|Weeks 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
2685352|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) IDS-SR Total Score for the Efficacy Sample Set|"IDS-SR was a 30-item self-report measured to assess core diagnostic depressive symptoms and atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the best rating and 3 being the worst rating. Besides item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items were not included in the calculation of the total score. The IDS-SR Total Score was the sum of ratings of 28 item scores. The possible IDSSR Total Score ranged from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items were recorded. If the number of items recorded was at least 23 and at most 27, the IDS-SR Total Score was the mean of the recorded items multiplied by 28, and was then rounded off to the first decimal place."|Weeks 8, 9, 10, 11, 12, 13, and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
2685382|NCT01360450|Primary|Time to Complete Detoxification|Time to complete detoxification is defined as 48 hrs off all opioids/benzodiazepines and study drug with acceptable withdrawal scores of <9 (on average we expect the infant to be enrolled in the study for 2-4 weeks). The scale used to assess withdrawal was the Modified Finnegan Neonatal Withdrawal Scale, which ranges from 0-41, 0 represents no withdrawal and 41 represent maximum withdrawal.|up to 4 weeks||||days||Standard Deviation|Mean
2685353|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical CGI-S for the Efficacy Sample Per Final Protocol|"The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician had to answer the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Weeks 8, 9, 10, 11, 12, 13, and 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
2685354|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical Global Impression Severity of Illness (CGI-S) for the Efficacy Sample Set|"The severity of illness for each participant was rated using the CGI-S. To perform this assessment, the study physician had to answer the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants."|Weeks 8, 9, 10, 11, 12,13 and 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
2685355|NCT01360632|Secondary|Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set Per Final Protocol|The SDS is a self-rated instrument used to measure the effect of the patient's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 11 and Week 14|All participants in the efficacy sample who met the revised randomization criteria for incomplete response as defined in protocol amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
2685356|NCT01360632|Secondary|Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set|The SDS is a self-rated instrument used to measure the effect of the patient's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the patient did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable.|Week 11 and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
2685357|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in SDS Mean Scores for the Efficacy Sample Per Final Protocol|The SDS was a self-rated instrument used to measure the effect of the participants symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores ranged from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all, to 10= extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS score were calculated over the three item scores. All three item scores were needed to be available with the exception of the work/school item score when this item was not applicable.|Week 11 and Week 14|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
2685358|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Scores for the Efficacy Sample Set|The SDS was a self-rated instrument used to measure the effect of the participants symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores ranged from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all to 10= extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS score were calculated over the three item scores. All three item scores were needed to be available with the exception of the work/school item score when this item was not applicable.|Week 11 and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
2685359|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Per Final Protocol|"The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome."|Week 8, 9, 10, 11, 12, and 13|All participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
2695813|NCT01275339|Secondary|Change in LV Hypertrophic Remodeling|Relative wall thickness, LV chamber dimensions, and wall thickness|12 weeks and 6 months|||||||
2685360|NCT01360632|Secondary|Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Set|"The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome."|Week 8, 9, 10, 11, 12, and 13|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
2685361|NCT01360632|Primary|Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol|"The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome."|Baseline and Week 14|Analysis was based on all participants in the Efficacy Sample who met the revised randomization criteria for incomplete response as defined in Protocol Amendment 3.|||Units on a scale||Standard Error|Least Squares Mean
2685362|NCT01360632|Primary|Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set|"The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS total score were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome."|Baseline and Week 14|The Efficacy Sample Set included all participants who had received at least one dose of study treatment and had both an end of Phase A (Week 8) value and at least 1 post randomization efficacy evaluation for MADRS Total Score in Phase B.|||Units on a scale||Standard Error|Least Squares Mean
2685363|NCT01360554|Secondary|Mean and Difference in Mean of the EuroQoL-5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Score|"The EQ-5D is a validated and reliable self-report preference-based measure developed by the EuroQoL Group to assess health-related quality of life. It consists of the EQ-5D descriptive system and a visual analogue scale-the EQ VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting no health problems, moderate health problems, and extreme health problems. The EQ VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state)."|Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.|The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment.|||Units on a scale.||95% Confidence Interval|Mean
2685364|NCT01360554|Secondary|Mean and Difference in Mean in Lung Cancer Symptom Scores as Assessed by the EORTC QLQ- LC13.|The QLQ-LC13 included questions specific to the disease associated symptoms (dyspnea, cough, haemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy, and alopecia), and analgesic use of lung cancer patients. Scores range from 0-100 and a higher score indicates greater degree of symptoms/problems. Overall scores present the mean score for that scale from all time-point data.|Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.|The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment.|||Units on a scale.||95% Confidence Interval|Mean
2685365|NCT01360554|Secondary|Mean and Difference in Mean in QLQ-C30 Symptoms as Assessed by the EORTC-QLQ-C30.|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Scores ranged from 0-100 where a higher score indicated a greater degree of symptoms/problems. Overall scores present the mean score for that scale from all time-point data.|Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.|The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment.|||Units on a scale.||95% Confidence Interval|Mean
2685366|NCT01360554|Secondary|Mean and Difference in Mean in Functioning and Global Quality of Life (QOL) as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Scores ranged from 0-100 where a higher score indicated a better level of quality of life. Overall scores present the mean score for that scale from all time-point data.|Data taken from Cycle 1 day 1 to the end of treatment or withdrawal, averaged (mean) to provide overall scores.|The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment.|||Units on a scale.||95% Confidence Interval|Mean
2685413|NCT01359943|Secondary|Change From Baseline in Participant's Assessment of Rheumatoid Arthritis (RA) Pain|"The patient's assessment of pain was performed using 100 mm visual analog scale (VAS) ranging from 0 (no pain) to 100 (unbearable pain) after the question Please indicate with a vertical mark through the horizontal line the most pain you had from your rheumatoid arthritis over the last 24 hours. A negative change from baseline indicates improvement."|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||score on a scale||Standard Error|Least Squares Mean
2685367|NCT01360554|Secondary|Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough Patient Reported Disease Symptoms.|TTD defined as the time from first dose (baseline) to the first time a patient's score in pain, dyspnea, fatigue or cough from the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-LC13) increased by ≥10 points. A ≥10 point increase in score had to be maintained for ≥2 consecutive cycles for the symptom to be considered deteriorated. Participants were censored at the last time when they completed an assessment for pain, dyspnea, fatigue or cough if they had not deteriorated. A 10 point or higher change in the score is perceived by participants as clinically significant.|Data taken from Cycle 1 day 1 to the end of treatment or withdrawal.|The PRO analysis set included all participants who started treatment and completed the baseline and at least 1 post-dosing PRO assessment.|||Months||95% Confidence Interval|Median
2685368|NCT01360554|Secondary|Trough Concentrations (Ctrough) of PF-05199265.|Mean Ctrough values of PF-05199265 observed from Cycle 2 through 5, Day 1 for dose compliant participants.|Baseline up to Cycle 5 Day 1|Participants treated with dacomitinib with at least one measured plasma concentration.|||Trough Plasma Concentration (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2685369|NCT01360554|Secondary|Trough Concentrations (Ctrough) of Dacomitinib.|Mean Ctrough values of dacomitinib observed from Cycle 2 through 5, Day 1 for dose compliant participants.|Baseline up to Cycle 5 Day 1|Participants treated with dacomitinib with at least one measured plasma concentration.|||Trough Plasma Concentration (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2685370|NCT01360554|Secondary|DR Based on Investigator Review.|DR was defined as the time from first documentation of response assessed by investigator review (CR or PR whichever occurred first) to date of progression or death due to any cause, whichever occurs first. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; PR: >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.|From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|DR was analyzed for a subgroup of participants in the ITT population, who had an objective tumor response.|||Months||95% Confidence Interval|Median
2685371|NCT01360554|Secondary|Duration of Response (DR) Based on Independent Radiologic Review.|DR was defined as the time from first documentation of response assessed by independent review (CR or PR whichever occurred first) to date of progression or death due to any cause, whichever occurs first. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; PR: >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.|From date of randomization until progression or death due to any cause. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|DR was analyzed for a subgroup of participants in the ITT population, who had an objective tumor response.|||Months||95% Confidence Interval|Median
2685372|NCT01360554|Secondary|BOR Per Investigator Review.|The BOR was the best response per RECIST (version 1.1) criteria as assessed by investigator assessment recorded from randomization until disease progression. Per RECIST version 1.1: CR: disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; PR: >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; PD: >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.|From date of randomization until progression or initiation of new anti-cancer therapy or death. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.|||Participants|||Number
2685373|NCT01360554|Secondary|Best Overall Response (BOR) Per Independent Radiologic Review.|The BOR was the best response per RECIST (version 1.1) criteria as assessed by independent assessment recorded from randomization until disease progression. Per RECIST version 1.1: Complete Response (CR): disappearance of all pre-existing lesions except nodal disease, with all nodal lesions decreased to normal size (short axis<10 mm) and no appearance of new unequivocal malignant lesions; Partial Response (PR): >=30% decrease from baseline sum of diameters of all target lesions with no unequivocal progression of pre-existing non-target lesions or appearance of new unequivocal malignant lesions; Progressive Disease (PD): >=20% increase in the sum of diameters of target lesions above the smallest sum observed, with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions.|From date of randomization until progression or initiation of new anti-cancer therapy or death. Participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.|||Participants|||Number
2685423|NCT01359904|Secondary|To Record the Effects of a Higher Dialysate Concentration of Glucose on Glycemic Control of Hemodialysis Patients With Type 2 Diabetes Mellitus by Measuring Serum Levels of Hemoglobin A1c.|Hemoglobin A1c levels will be measured before the intervention and after to assess any difference in the value. The blood samples were taken prior to dialysis treatments mid-week for each subject at baseline and at the end of the study in both the control and intervention groups.|3 months||||percent||Full Range|Median
2685374|NCT01360554|Secondary|OS in KRAS-WT Participants.|OS was defined as the time from randomization to the date of death for any cause. In the absence of confirmation of death, survival time was censored at the last date the patient was known to be alive (ie, at their last known alive date from long term follow-up). Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.|From date of randomization until the date of death from any cause or last date known to be alive, participants were followed up regardless of the reason for discontinuation from study treatment at intervals of no longer than every 2 months.|ITT population for KRAS-WT participants: all participants who were confirmed as having KRAS-WT tumors, randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
2685375|NCT01360554|Secondary|Overall Survival (OS).|OS was defined as the time from randomization to the date of death for any cause. In the absence of confirmation of death, survival time was censored at the last date the patient was known to be alive (ie, at their last known alive date from long term follow-up).|From date of randomization until the date of death from any cause or last date known to be alive, participants were followed up regardless of the reason for discontinuation from study treatment at intervals of no longer than every 2 months.|The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
2685376|NCT01360554|Secondary|PFS Based on Investigator Review in KRAS-WT Participants.|PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Investigator's Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions. Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|ITT population for KRAS-WT participants: all participants who were confirmed as having KRAS-WT tumors, randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
2685377|NCT01360554|Secondary|PFS Based on Investigator Review.|PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Investigator's Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
2685378|NCT01360554|Primary|Progression-Free Survival (PFS) Per Independent Radiologic Review in KRAS Wild-type (WT) Participants.|PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Independent Radiologic Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions. Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|ITT population for KRAS-WT participants: all participants who were confirmed as having KRAS-WT tumors, randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
2685379|NCT01360554|Primary|Progression-Free Survival (PFS) Per Independent Radiologic Review.|PFS was defined as the time from randomization to the date of disease progression as by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 per Independent Radiologic Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy.|The ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.|||Months||95% Confidence Interval|Median
2685380|NCT01360450|Secondary|Cumulative Dose of Opioid and Benzodiazepine|We will determine the total amount of opioid and benzodiazepine needed from the start of detoxification to the end of the the detoxification.|2-4 weeks|No data is available for this outcome measure, as it was not collected.||||||
2685381|NCT01360450|Secondary|Cardiovascular Side-effects Changes HR and BP|Changes in Heart Rate (HR) and BP for 48 hrs after starting study drug and for 48hrs after stopping study drug|48 hrs after starting study drug and for 48hrs after stopping study drug|No data is available for this outcome measure, as it was not collected.||||||
2685383|NCT01360398|Secondary|AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum by Severity|An Acute Exacerbation in a COPD patient is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum production and beyond normal day to day variations, that is acute in onset and may warrant a change in regular medication in a patient with underlying COPD. AECOPD severity was assessed as: any, mild, moderate and severe. Any = any COPD symptom regardless of severity. Mild = Worsening symptoms of COPD that are self-managed by the patient. Moderate = Worsening symptoms of COPD that require treatment with oral corticosteroids and/or antibiotics. Severe = Worsening symptoms of COPD that require treatment with in-patient hospitalisation or home care intervention.|During Year 1|The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.|||AECOPD/subject|||Number
2685384|NCT01360398|Secondary|Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum|Viral pathogens assessed were: respiratory syncytial virus (RSV), parainfluenza virus (PIV), entero rhinovirus (ENV), human metapneumovirus (HMP), influenza virus (INV), adenovirus (ADV), coronavirus (CRV), human bocavirus (HBoV) and any virus. Severe exacerbations were defined as worsening symptoms of COPD that required treatment with in-patient hospitalisation or home care intervention.|During Year 1|The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.|||AECOPD/subject|||Number
2685385|NCT01360398|Secondary|Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum|Viral pathogens assessed were: respiratory syncytial virus (RSV), parainfluenza virus (PIV), entero rhinovirus (ENV), human metapneumovirus (HMP), influenza virus (INV), adenovirus (ADV), coronavirus (CRV), human bocavirus (HBoV) and any virus. Moderate exacerbations were defined as worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics.|During Year 1|The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.|||AECOPD/subject|||Number
2685386|NCT01360398|Secondary|Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum|Viral pathogens assessed were: respiratory syncytial virus (RSV), parainfluenza virus (PIV), entero rhinovirus (ENV), human metapneumovirus (HMP), influenza virus (INV), adenovirus (ADV), coronavirus (CRV), human bocavirus (HBoV) and any virus. Mild exacerbations were defined as worsening symptoms of COPD that were self-managed by the patient.|During Year 1|The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.|||AECOPD/subject|||Number
2685387|NCT01360398|Secondary|AECOPD Rate With Overall and Specific Viral Pathogens in Sputum|Viral pathogens assessed were: respiratory syncytial virus (RSV), parainfluenza virus (PIV), entero rhinovirus (ENV), human metapneumovirus (HMP), influenza virus (INV), adenovirus (ADV), coronavirus (CRV), human bocavirus (HBoV) and any virus.|During Year 1|The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.|||AECOPD/subject|||Number
2685388|NCT01360398|Secondary|AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay|Bacterial pathogens assessed, by PCR assay were: Hi, Mcat, Sp, Sta, Psa, Streptococcus pyogenes (Spyo) and any bacteria.|During Year 1|The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.|||AECOPD/subject|||Number
2685389|NCT01360398|Secondary|Number of Subjects With Serious Adverse Events (SAEs) Possibly Related/Linked to Withdrawal|Serious adverse events (SAEs) include medical occur-rences that result in death, are life threatening, require hospitali-zation or prolongation of hospitalization or result in disabil-ity/incapacity.|During Year 1|The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.|||Participants|||Count of Participants
2685390|NCT01360398|Secondary|Number of Subjects Receiving Various Health Care Types During AECOPD|AECOPD health care type included: general practitioners (other than the study doctor), pneumologists, other specialists, hospital emergency department, home care nurses, pulmonary rehabilitation programs and/or nutrition advices.|During Year 1|The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.|||Participants|||Count of Participants
2685391|NCT01360398|Secondary|Change From Baseline COPD EQ-5D Index and Visual Analogue Scale (VAS) Scores at Enrollment and Any AECOPD Visit|The EQ-5D is an established measure of generic health outcome that provides a simple descriptive profile and a single index value that can be used in clinical and economic evaluation of healthcare and in population surveys. Its current format is 3-level and 5 dimensional (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was derived from the ratings recorded every 3 months for each of the five individual items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was 0 (worst health state) to 100 (best health state). The negative numbers presented represent a decrease from baseline values and a worsening of health.|During Year 1|The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.|||EQ-5D AECOPD scores||Standard Deviation|Mean
2685414|NCT01359943|Secondary|Change From Baseline in Tender 68-joint Count|The 68 joints assessed for tenderness included the 8 distal interphalangeal, 10 proximal interphalangeal and 10 metacarpophalangeal joints of the hands, the 10 metatarsophalangeal and 10 proximal interphalangeal joints of the feet, the 2 wrists, 2 elbows , 2 shoulders , 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 hip, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Joint tenderness was graded present (1) or absent (0). A negative change from baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||Number of joints||Standard Error|Least Squares Mean
2685392|NCT01360398|Secondary|Change From Baseline COPD Nottingham Extended Activities of Daily Living Scale (NEADL) Scores at Enrollment and Any AECOPD Visit|The NEADL assessed (quarterly in the present study) the ease or difficulty in performing extended activities of daily living. The NEADL scale contains 22 items, each measured on a 4-point Likert scale. There are four dimensions: mobility (6 items); kitchen (5 items); domestic (5 items); leisure (6 items). These are summed producing a total score reflecting general functioning. Each of the 22 individual items had 2 possible scores (0 or 1). Therefore, the range of the NEADL score was 0 to 22. Lower scores indicate greater levels of disability while higher scores indicate greater independence.|During Year 1|The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.|||NEADL AECOPD scores||Standard Deviation|Mean
2685393|NCT01360398|Secondary|Change From Baseline COPD Assessment Test (CAT) Scores at Enrollment and Any AECOPD Visit|The COPD assessment test (CAT) is a validated self-administered instrument designed to provide a simple and reliable measure of health status in COPD patients. Its properties have been shown to be similar to the St George's respiratory questionnaire (SGRQ). The CAT comprises 8 items and has a scoring range of 0-40, 0= most positive answer and 40= most negative answer. In this study, the subjects were to complete the CAT questionnaire every 3 months.|During Year 1|The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.|||COPD CAT Score||Standard Deviation|Mean
2685394|NCT01360398|Secondary|Change From Baseline EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Scores at Enrollment and Any AECOPD Visit|The exacerbations of chronic pulmonary disease tool version 1.0 (EXACT) is a validated self-administered instrument that evaluates the effects of pharmacologic treatment on acute exacerbations of COPD. Analyses of exacerbations in relation to morning or evening EXACT-PRO e-diaries were presented as follows: descriptive statistics on the EXACT daily scores tabulated at enrolment, at any stable and at any, mild, moderate or severe exacerbation visit. EXACT-PRO contains 14 questions with scores ranging from 0 to 4, where 0= best outcome while 4= worse outcome.|During Year 1|The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.|||COPD EXACT Score||Standard Deviation|Mean
2685395|NCT01360398|Secondary|Mean Number of Days Between 2 Consecutive AECOPDs|The number of days between 2 consecutive exacerbations, as estimated by the investigator, was calculated only whenever the first exacerbation had an end date.|During Year 1|The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.|||Days||Standard Deviation|Mean
2685396|NCT01360398|Secondary|Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria|Sputum samples were tested by bacterial species (any bacteria, Hi, Mcat, Sp, Sta, Psa and other bacteria), or overall and were obtained from culture at each visit (enrollment, any stable visit, any exacerbation visit, any mild exacerbation visit, any moderate exacerbation visit, any severe exacerbation visit). This endpoint presents results for Sta, Psa and other bacteria.|During Year 1|The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.|||sputum samples|||Number
2685397|NCT01360398|Secondary|Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp|Sputum samples were tested by bacterial species (any bacteria, Hi, Mcat, Sp, Sta, Psa and other bacteria), or overall and were obtained from culture at each visit (enrollment, any stable visit, any exacerbation visit, any mild exacerbation visit, any moderate exacerbation visit, any severe exacerbation visit). This endpoint presents results for Mcat and Sp.|During Year 1|The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.|||sputum samples|||Number
2685398|NCT01360398|Secondary|Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi|Sputum samples were tested by bacterial species (any bacteria, Hi, Mcat, Sp, Sta, Psa and other bacteria), or overall and were obtained from culture at each visit (enrollment, any stable visit, any exacerbation visit, any mild exacerbation visit, any moderate exacerbation visit, any severe exacerbation visit). This endpoint presents results for any bacteria and Hi.|During Year 1|The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.|||sputum samples|||Number
2685399|NCT01360398|Primary|Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum|Bacterial pathogens assessed, by culture, were: Haemophilus influenzae (Hi), Moraxella catarrhalis (Mcat), Streptococcus pneumoniae (Sp), Staphylococcus aureus (Sta), Pseudomonas aeruginosa (Psa), any bacteria or other bacteria. Overall exacerbation rate is the average number of exacerbations for each subject during their time in the study.|During Year 1|The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.|||AECOPD/subject|||Number
2685400|NCT01360398|Primary|Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens|Bacterial pathogens assessed were: Haemophilus influenzae (Hi), Moraxella catarrhalis (Mcat), Steptococcus pneumoniae (Sp), Staphylococcus Aureus (Sta), Pseudomonas aeruginosa (Psa), any or other. For each bacteria, the means and CIs were estimated from Negative Binomial model taking into account the follow up time.Estimated exacerbations were presented as mean number of exacerbations/ subject/ year.|During Year 1|The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.|||AECOPD/subject/year||95% Confidence Interval|Mean
2685424|NCT01359904|Primary|Hemoglobin A1c Levels|post intervention hemoglobin A1c levels|3 months|We planned forty subjects to detect a difference in the mean change in the HbA1c from baseline to at the end of the study of 1% among the two dialysate concentration groups with a two-tailed t-test and variance of 1%, the required sample size will be 20 for each group with a power of 88% and alpha set at 0.05.|||percent||Full Range|Median
2685401|NCT01360398|Primary|Mean Estimated Number of Acute Exacerbation of COPD (AECOPD)|An Acute Exacerbation in a COPD patient is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum production and beyond normal day to day variations, that is acute in onset and may warrant a change in regular medication in a patient with underlying COPD The Means and Confidence Intervals (CI) were estimated using the Negative Binomial model taking into account time to follow up. Estimated exacerbations were presented as mean number of exacerbations per (/) subject/ year.|During year 1|The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.|||AECOPD/subject/year||95% Confidence Interval|Mean
2685402|NCT01360229|Primary|Change in the Modified Fatigue Impact Scale Total (MFIS) Between Treatment Groups|The primary outcome measure will be the change between the baseline visit and 6-week time point in the Modified Fatigue Impact Scale Total (MFIS) between treatment groups. The range of the score is 0-84 with higher scores reflecting more severe fatigue.|6 weeks||||units on a scale||Standard Deviation|Mean
2685403|NCT01360021|Secondary|Use of Rescue Medication Day and Night (Total Daily Rescue Medication Use)|Total daily rescue medication use is calculated as the sum of morning and evening use each day and averaged over the 12 weeks treatment periods to calculate the treatment period mean. Baseline= Mean rescue medication used during run-in period ; Trt Avg=Mean rescue medication used during double-blind period.|Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).|||Inhalations/24 hrs||Standard Deviation|Mean
2685404|NCT01360021|Secondary|Night-time Awakenings Due to Asthma Symptoms(% Awakening-free Nights)|The percentage of days with no awakenings due to asthma. Baseline= Mean % awakening-free nights during run-in period ; Trt Avg=Mean % awakening-free nights during double-blind period.|Recorded 6:00 - 11:00 AM for 14 weeks|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).|||Percentage of days with no awakenings||Standard Deviation|Mean
2685405|NCT01360021|Secondary|Asthma Symptoms Score (Total)|The total score is calculated as sum of the morning and evening scores of each day and the treatment period mean score is defined as the mean of all total score recorded during the 12-week treatment period. Trt Avg=Mean total score of double-blind period values.(day/night score ranges from 0 to 3; 0=no asthma symptoms; 3= unable to do normal activities (or to sleep) due to asthma). Higher score represents worse outcome.|Recorded between 6:00 - 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).|||Asthma score on a scale of 0 to 3||Standard Deviation|Mean
2685406|NCT01360021|Secondary|Peak Expiratory Flow||Recorded morning upon rising and evening before sleep for 14 weeks|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).|||L/Min||Standard Deviation|Mean
2685407|NCT01360021|Primary|Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose|Descriptive statistics for predose FEV1(L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.|Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).|||Liters||Geometric Coefficient of Variation|Geometric Mean
2685408|NCT01360021|Primary|Forced Expiratory Volume in 1 Second (FEV1) - Post Dose|Descriptive statistics for post-dose FEV1 (L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.|60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg|Full analysis set: It consist of all randomized patients who received at least one dose of study medication and contributed sufficient data for at least one efficacy endpoint (Primary variable).|||Liter||Geometric Coefficient of Variation|Geometric Mean
2685409|NCT01359943|Secondary|Change From Baseline in ESR|Blood for this assessment was obtained to monitor disease activity and response to therapy. A negative change from baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||mm/hr||Standard Error|Least Squares Mean
2685410|NCT01359943|Secondary|Change From Baseline in hsCRP|Blood for this assessment was obtained to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||mg/L||Standard Error|Least Squares Mean
2685411|NCT01359943|Secondary|Change From Baseline in Physician's Global Assessment of Disease Activity|"The physician's global assessment of disease activity was performed using 100 mm VAS ranging from 0 (very good) to 100 (very poor), after the question Considering all the ways rheumatoid arthritis affects your patient, how would you rate his or her current condition?. A negative change from baseline indicates improvement."|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||score on a scale||Standard Error|Least Squares Mean
2685412|NCT01359943|Secondary|Change From Baseline in Participant's Global Assessment of Disease Activity|"The patient's global assessment of disease activity was performed using 100 mm VAS ranging from 0 (very good) to 100 (very poor), after the question Considering all the ways rheumatoid arthritis affects you, please indicate with a vertical mark through the horizontal line how well you are doing today. A negative change from baseline indicates improvement."|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||score on a scale||Standard Error|Least Squares Mean
2685473|NCT01359046|Primary|Urinary Tract Infection Rate|Number of subjects diagnosed with a urinary tract infection (UTI) within 6 weeks of surgery. A UTI is defined as any symptoms requiring antibiotic treatment, a urine culture with >10^5 cfu/mL, or a urine culture with >10^3 cfu/mL and evidence of pyuria.|within 6 weeks post surgery||||Participants|||Count of Participants
2685415|NCT01359943|Secondary|Change From Baseline in Swollen 66-joint Count|The 66 joints assessed for swelling included the 8 distal interphalangeal, 10 proximal interphalangeal and 10 metacarpophalangeal joints of the hands, the 10 metatarsophalangeal and 10 proximal interphalangeal joints of the feet, the 2 wrists, 2 elbows , 2 shoulders , 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Swelling was graded present (1) or absent (0). A negative change in baseline indicates improvement.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||Number of joints||Standard Error|Least Squares Mean
2685416|NCT01359943|Secondary|Percentage of Participants With European League Against Rheumatism (EULAR) Response|EULAR response criteria are based on DAS28 status in combination with DAS28 improvements. The EULAR response criteria are as follows: present DAS28 <3.2 with DAS28 improvement >1.2 corresponds to 'good response'; present DAS28 <3.2 with DAS28 improvement between 0.6 to 1.2, or present DAS28 between 3.2 to 5.1 with DAS28 improvement from 0.6 to >1.2, or present DAS28 >5.2 with DAS28 improvement >1.2 correspond to 'moderate response; present DAS28 <3.2 with DAS28 improvement <0.6, or present DAS28 between 3.2 to 5.1 with DAS28 improvement <0.6, or present DAS28 >5.1 with DAS28 improvement <0.6 to 1.2 correspond to 'no response'.|baseline, 12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||Percentage of participants|||Number
2685417|NCT01359943|Secondary|Change From Baseline in Disease Activity Score 28 Response Using ESR (DAS28-ESR)|The Disease Activity Score (DAS) is a combined index to measure disease activity in RA participants. DAS28 is determined using the following variables: 28-joint counts (tender28 and swollen28), erythrocyte sedimentation rate (ESR), and the participant's general health (GH) or global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 = and 100 = ). Using the data from these variables, DAS28-ESR is calculated using the following formula: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * GH. The calculation results in a DAS28-ESR score from 0 to 10 indicating the current activity of the rheumatoid arthritis of your patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6. A negative change from baseline indicates improvement.|baseline, 12 weeks|Participants from the full analysis set (FAS), who had values at both baseline and week 12, were included in this analysis. The FAS included all participants who were randomized to study treatment.|||score on a scale||Standard Error|Least Squares Mean
2685418|NCT01359943|Secondary|Change From Baseline in DAS28 Using High Sensitivity C-reactive Protein (hsCRP) (DAS28-CRP)|The Disease Activity Score (DAS) is a combined index to measure disease activity in RA participants. DAS28-CRP is determined using the following variables: 28-joint counts (tender28 and swollen28), CRP, and the participant's general health (GH) or global disease activity measured on a Visual Analogue Scale (VAS) of 100 mm (0 = and 100 = ). Using the data from these variables, DAS28-CRP is calculated using the following formula: DAS28-4(crp) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014*GH + 0.96. The calculation results in a DAS28-CRP score from 0 to 10 indicating the current activity of the rheumatoid arthritis of your patient. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6. A negative change from baseline indicates improvement.|baseline, 12 weeks|Participants from the full analysis set (FAS), who had values at both baseline and week 12, were included in this analysis. The FAS included all participants who were randomized to study treatment.|||score on a scale||Standard Error|Least Squares Mean
2685419|NCT01359943|Secondary|Change From Baseline in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score.|The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. In this trial, only the disability dimension was used. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Within each of the 8 categories, only the item indicating the most severe impairment contributes to the category score. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from baseline indicates improvement.|baseline, 12 Weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||score on a scale||Standard Error|Least Squares Mean
2685420|NCT01359943|Secondary|Percentage of Participants Who Achieve ACR50 and ACR70|A participant was considered to be a responder according to the ACR50 or ACR70 criteria if the participant had at least 50% or 70% improvement, respectively, in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).|12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||Percentage of participants|||Number
2685421|NCT01359943|Primary|Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20)|A participant was considered to be a responder according to the ACR20 criteria if the participant had at least 20% improvement in both the tender joint count and swollen joint count measures, and in at least 3 of the following 5 measures: patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, and/or C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR).|12 weeks|Full analysis set (FAS): The FAS included all participants who were randomized to study treatment.|||Percentage of participants|||Number
2685422|NCT01359904|Secondary|the Number of Infections Related to Vascular Access in Dialysis Among Those Who Receive a Higher Glucose Concentration in the Dialysate and Those Who Receive the Standard Concentration|In the two groups, we will measure the number of episodes of vascular access related infections ie. catheter, AV fistula or AV graft associated infections in the study period. The episode was defined as a diagnosis in the chart written by the nurse or physician with a prescription of antibiotics.|3 months||||episodes|||Number
2685474|NCT01359007|Secondary|Number of Participants Who Experienced Toxicity||2 years||||Participants|||Count of Participants
2685475|NCT01359007|Secondary|Overall Survival||2 years|Data was not collected from any single study participant.||||||
2685425|NCT01359904|Secondary|Episodes of Hypoglycemia|record number of episodes during dialysis with serum glucose below 4 mmol/L by glucometer|3 months|We planned forty subjects to detect a difference in the mean change in the HbA1c from baseline to at the end of the study of 1% among the two dialysate concentration groups with a two-tailed t-test and variance of 1%, the required sample size will be 20 for each group with a power of 88% and alpha set at 0.05.|||episodes|||Number
2685426|NCT01359748|Primary|BP Measurement Using Multifunction KEITO|"Prior starting the measurement phase using Multifunction KEITO, the under test device was reset before each new measurement.~The subject has to be at rest at least 60 seconds before be measured."|30 seconds||||mmHg||Standard Deviation|Mean
2685427|NCT01359748|Primary|BP Measurements Using the Reference Auscultatory Sphygmomanometer|"The subject was measured by the two observers at the same time using the reference sphygmomanometer and double stethoscope.~The observers agree to take the K5 korotkoff sound. Each observer takes notes of their own measures."|Five minutes||||mmHg||Standard Deviation|Mean
2685428|NCT01359735|Secondary|Subject Reported Signs and Symptoms|Subjects reported signs or symptoms, based on the following 6 items, each scored as none (=0), mild (=1), moderate (=2), or severe (=3): irritation, itchiness, burning, tenderness, pain, and stinging. Item scores were averaged.|At each evaluation visit: Weeks 3, and 12 post-surgery.|The ITT population – all subjects who underwent MMS. Both the total score and individual item score of the two signs and symptoms rating scales were summarized descriptively at Weeks 4, 7, and 13 as well as at the treatment endpoint and compared using a two-sample t-test, and the P-value of a 1-sided test was reported.|||units on a scale||Standard Deviation|Mean
2685429|NCT01359735|Secondary|Investigator Reported Signs and Symptoms|Investigator reported signs and/or symptoms, based on the following 12 items, each scored as none (=0), mild (=1), moderate (=2), or severe (=3): Erythema, Erosion, Ulceration, Swelling, Scarring, Infection, Crusting, Necrosis, Peeling, Contact Dermatitis, Hyper/Hypopigmentation. Item scores were averaged.|At each evaluation visit: Weeks 3 and 12 post-surgery.|The ITT population–all subjects who underwent MMS. Both total score and individual item score of the two signs and symptoms rating scales summarized descriptively at Weeks 4, 7, and 13 as well as at the treatment endpoint and compared using a two-sample t-test. the P-value of a 1-sided test was reported.|||units on a scale||Standard Deviation|Mean
2685430|NCT01359735|Secondary|Time in Days to Wound Closure|The Kaplan-Meier survival analysis was used to calculate the mean time in days to complete wound closure.|Over the 12 week treatment period|The ITT population – all subjects who underwent MMS. The Log-rank test was used to test for an inter-group difference.|||Days||Standard Deviation|Mean
2685431|NCT01359735|Secondary|The Number of Subjects With Complete Wound Closure at Each Evaluation Visit.|Complete wound closure was assessed at each evaluation visit.|Over 12 weeks or until wound closure, which ever occurred first. Following completion of treatment subjects were followed for a further 4 weeks|The ITT population – all subjects who underwent MMS. Fisher’s exact test was used to examine the difference in proportion of subjects with complete wound closure at each of the corresponding time points between the two treatment groups, and the P-value of a 1-sided test was reported.|||participants|||Number
2685432|NCT01359735|Primary|The Primary Efficacy Measure Was the Investigator's Global Assessment of Healing (IGAH).|The IGAH is a four-point scale based on the following assessment scores: 0 = not effective, 1 = slightly effective, 2 = moderately effective, 3 = very effective. The descriptive statistics for both a continuous variable and a categorical variable were summarized for IGAH by treatment week and treatment endpoint. The Wilcoxon rank-sum test was used to test the difference in IGAH score between HP802-247 and bacitracin ointment for each treatment week and treatment endpoint. Since this was a small and exploratory study, the P-value of a 1-sided test was reported.|13 weeks- The IGAH was measured at study Weeks 4 and 13|The ITT population – all subjects who underwent MMS.|||units on a scale||Standard Deviation|Mean
2685433|NCT01359644|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe|AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)|All participants who received at least 1 dose of study drug and entered follow-up period|||Participants|||Number
2685434|NCT01359644|Secondary|Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy|AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe.|First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)|All participants who received at least 1 dose of study drug.|||Participants|||Number
2685435|NCT01359644|Secondary|Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24|Change from baseline in log10 HCV RNA at scheduled sampling time.|Baseline, Follow-up week 24|The analysis was performed in all treated participants who received at least 1 dose of active study therapy.|||IU/mL||Standard Deviation|Mean
2685436|NCT01359644|Secondary|Percentage of Participants Who Experienced Viral Relapse During Follow-up Period|Viral relapse during follow-up is defined as any confirmed quantifiable hepatitis C virus (HCV) RNA ≥25 IU/mL with HCV RNA levels less than the lower limit of quantitation, target detected or target not detected, ie, HCV RNA <25 IU/mL at the end of treatment.|Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
2685437|NCT01359644|Secondary|Percentage of Participants With Viral Breakthrough During the Treatment Period|Viral breakthrough is defined as any confirmed increase in viral load ≥1 log from nadir or any confirmed hepatitis C virus RNA levels ≥25 IU/mL on or after Week 8.|First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
2685438|NCT01359644|Secondary|Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)|SVR24 was defined as participant's hepatitis C virus RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 24. DCV=daclatasvir, SOF=sofosbuvir.|Follow-up Week 24|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here the ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
2685439|NCT01359644|Primary|Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)|SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA <25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir.|Follow-up Week 12|The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The ‘n’ signifies those participants evaluable for this measure at specified time points for each group, respectively.|||Percentage of participants|||Number
2685440|NCT01359449|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination|Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants in the Menactra vaccine group, intent to treat population|||Participants|||Number
2685441|NCT01359449|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age|"Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.~Grade 3 reactions defined as: Tenderness - Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever - > 39.5°C; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable."|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants in the Menactra vaccine group, intent to treat population|||Participants|||Number
2685442|NCT01359449|Secondary|Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age|"Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.~Grade 3 reactions defined as: Tenderness - Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever - > 39.5°C; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable."|Day 0 up to Day 7 post-vaccination|Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, intent-to-treat population|||Participants|||Number
2685443|NCT01359449|Secondary|Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group)|Pediacel vaccine administered only to the Menactra Vaccine Group. Booster response was defined as subjects with pre-dose titers < 4xLLOQ and have a 4-fold rise rate; or subjects with pre-dose titers ≥ 4xLLOQ and have a 2-fold rise rate|28 days post-vaccination|Pediacel® vaccine antigen booster responses were determined in the per-protocol population of the Menactra® vaccine group|||Participants|||Number
2685444|NCT01359449|Secondary|Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.|Immunogenicity tests were performed at 18 and 19 months of age, respectively, before and after Pediacel® vaccination in the Menactra vaccine group|28 days post-vaccination|Geometric Mean Titers of of Pediacel vaccine antigens were determined in the per-protocol population of the Menactra® vaccine group.|||Titers||95% Confidence Interval|Geometric Mean
2685445|NCT01359449|Secondary|Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.|Immunogenicity tests were performed at 19 months of age in Menactra vaccine group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate vaccine group after Menjugate® vaccination|28 days post-vaccination|Immunogenicity using Serum Bovine Albumin Human Complement titers were determined in the per-protocol population|||Participants|||Number
2685446|NCT01359449|Secondary|Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.|Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination.|28 days post-vaccination|Geometric Mean Titers of Serum Bovine Albumin Human Complement titers were determined in the per-protocol population|||Titers||95% Confidence Interval|Geometric Mean
2685476|NCT01359007|Secondary|Response Rate (Either Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria)||2 years|Data was not collected from any single study participant.||||||
2685477|NCT01359007|Secondary|Proportion of Patients Whose Pancreatic Cancer is Operable (Resulting in R0 or R1 Resection) Following Induction Therapy.||2 years|Data was not collected from any single study participant||||||
2685447|NCT01359449|Primary|Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.|Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination|28 days post-vaccination|Immunogenicity using Serum Bovine Albumin Baby Rabbit titers were determined in the per-protocol population|||Participants|||Number
2685448|NCT01359449|Primary|Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.|Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination|28 days post-vaccination|Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit titers were determined in the per protocol population|||Titers||95% Confidence Interval|Geometric Mean
2685449|NCT01359410|Post-Hoc|Intraoperative Complications Incurred by Participants||100 days or removal of drain||||intraoperative complications|||Number
2685450|NCT01359410|Secondary|Number of Non-pancreatic Adverse Events||100 days or removal of drain||||non-pancreatic adverse events|||Number
2685451|NCT01359410|Secondary|Time to Drain Removal||100 days or removal of drain|(1) participant in the mesh reinforcement arm was not evaluable due to death and (1) participant in the non-mesh reinforcement arm was not evaluable due to death.|||days||95% Confidence Interval|Median
2685452|NCT01359410|Secondary|Occurrence of Any Fistula as Defined by the ISGPF Pancreatic Leak Grading System||100 days or removal of drain|(1) participant in the mesh reinforcement arm was not evaluable due to death and (1) participant in the non-mesh reinforcement arm was not evaluable due to death.|||Participants|||Count of Participants
2685453|NCT01359410|Primary|Clinically Significant Postoperative Pancreatic Leak at Any Time as Defined by the ISGPF Pancreatic Leak Grading System|"Identified as being a grade B or grade C fistula or any fistula that altered the patients' management in any way~Determination of severity of pancreatic fistula was done using the ISGPF(International Study Group Pancreatic Fistula) leak/fistula/pancreatic occlusion failure~Grade B: >3x normal serum amylase, often well clinical condition, yes/no specific treatment, negative/positive ultrasound/CT, usually persistent drainage (>3 weeks), yes/no signs of infection, yes/no readmission, no sepsis, no reoperation, no death related to fistula~Grade C: >3x normal serum amylase, ill appearing/bad, requires specific treatment, positive ultrasound/CT, persistent drainage (>3 weeks), signs of infection, yes/no readmission, sepsis, reoperation, and death related to fistula"|100 days or removal of drain|(1) participant in the mesh reinforcement arm was not evaluable due to death and (1) participant in the non-mesh reinforcement arm was not evaluable due to death.|||Participants|||Count of Participants
2685454|NCT01359371|Secondary|Estimate the Costs of Implementing the Volunteer Peer Telephone Counseling Including Cost Per Patient and Cost Per Quit.||Collect cost of labor data and number of hours spent by the volunteers providing peer telephone counseling.|||||||
2685455|NCT01359371|Secondary|Evaluate Satisfaction With Program, Barriers and Facilitators to Implementation and Participating in the Program, and Quality of the Counseling||Interviews with patients, volunteers, and staff; observing volunteer phone calls|||||||
2685456|NCT01359371|Secondary|Determine if There Were Differences in Quit Rates Between Those That do and do Not Participate in the Peer Telephone Cessation Counseling.||7-day point prevalence quit rate on 60-day survey|||||||
2685457|NCT01359371|Primary|Determine Differences in the Demographics, Health Characteristics, and Smoking Characteristics of Those Who Were Reached 3-4 Times and Those Who Were Reached 0-2 Times for Peer Telephone Counseling.|Bivariate relationships between number of times a veteran was reached by the volunteer and smoking outcomes as well as other covariates were calculated, using Wald chi-square tests for differences in proportions.|60-day survey - one survey, completed 60 days after discharge|At 60-days after in-patient discharge, seven-day point-prevalence quit rates were higher for those reached 3-4 times.|||participants|||Number
2685458|NCT01359254|Secondary|Survival at Day 100|Percent of subjects who are alive 100 days after the stem cell infusion|100 days|The only enrolled patient failed to complete the study due to death.||||||
2685459|NCT01359254|Primary|Cord Blood Engraftment by Day 100|"Percent of subjects with cord blood engraftment on or before day 100. Detectable cord blood engraftment should be present by day 100 in at least 50% of patients.~As of 44 days post-transplant, only haploidentical donor chimerism achieved in the one patient enrolled in the Fludarabine, melphalan, and ATG arm. There were no cord cells detected for this patient."|100 days|The only enrolled patient failed to complete the study due to death.||||||
2685460|NCT01359150|Secondary|Geometric Mean Titer (GMT) of Anti-Influenza Antibody|Antibody geometric mean titer (GMT) for 3 influenza antigens antigens (B, H1N1, H3N2) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMT and corresponding 2-sided 95% confidence intervals (CI) were evaluated.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.|||titer||95% Confidence Interval|Geometric Mean
2685461|NCT01359150|Secondary|Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody|Antibody geometric mean concentration (GMC) for 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C) as measured by geometric mean of three independent determinations of the antibody response of that antigen. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.|||microgram/milliliter (mcg/mL)||95% Confidence Interval|Geometric Mean
2685478|NCT01359007|Primary|To Estimate, Among Patients With Locally Advanced Unresectable and Borderline Resectable Pancreatic Cancer, the Proportion in Whom R0 Resection is Achieved After Neoadjuvant Therapy.||2 years|Data was not collected from any single study participant.||||||
2695814|NCT01275339|Secondary|Change in Indices of Systolic Function|Stroke volume, EF, LV twist, and stress-corrected midwall shortening by echo and 3D multiparametric strain and EF by MRI|12 weeks and 6 months|||||||
2685462|NCT01359150|Secondary|Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29)|GMFRs for the 3 influenza antigens (B, H1N1, H3N2) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. CIs for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.|||fold rise||95% Confidence Interval|Geometric Mean
2685463|NCT01359150|Secondary|Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29)|Geometric mean fold rises (GMFRs) for the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) from pre-vaccination (Day 29) to Day 64 (Day 35 post-vaccination) were computed using the logarithmically transformed assay results. Confidence intervals (CIs) for GMFR are back transformations of a CI based on the Student t-distribution for the mean logarithm of the titers. Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.|||fold rise||95% Confidence Interval|Geometric Mean
2685464|NCT01359150|Secondary|Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine|Seroprotection was defined as achieving protective antibody titers to the influenza vaccine as measured by a hemagglutination inhibition (HAI) assay titer of >= 1:40 in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.|||percentage of participants||95% Confidence Interval|Number
2685465|NCT01359150|Secondary|Percentage of Participants Who Responded to Each of the 3 Influenza Antigens|Response to the influenza vaccine (seroconversion) was defined as >= 4 fold increase in antibody titers from vaccination baseline (Day 29) in each of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.|||percentage of participants||95% Confidence Interval|Number
2685466|NCT01359150|Secondary|Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens|Response to the pneumococcal vaccine (seroconversion) was defined as >= 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in each of the 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.|||percentage of participants||95% Confidence Interval|Number
2685467|NCT01359150|Primary|Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64)|Satisfactory humoral response to the influenza vaccine was defined as >= 4 fold increase in antibody titers from vaccination baseline (Day 29) in at least 2 of 3 influenza antigens (B, H1N1, H3N2). Data was stratified by the background methotrexate use.|Day 64 (EOS)|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.|||percentage of participants||95% Confidence Interval|Number
2685468|NCT01359150|Primary|Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64)|Satisfactory humoral response to the pneumococcal vaccine was defined as greater than or equal to (>=) 2 fold increase in antibody concentrations from vaccination baseline (Day 29) in at least 6 of 12 pneumococcal antigens (1, 3, 4, 5, 6B, 7F, 9V, 14, 19A, 19F, 23F, 18C). Data was stratified by the background methotrexate use.|Day 64 (End of Study [EOS])|Evaluable immunogenicity population:eligible,randomized participants;who met rheumatoid arthritis disease activity criteria;received vaccination as scheduled and >=80% study drug;had pre and post-vaccination blood draw;complete set of assay results;had no major protocol violations.n=participants evaluable at specified categories for each arm group.|||percentage of participants||95% Confidence Interval|Number
2685469|NCT01359111|Secondary|Proportion of Injections Administered With Needle Bevel up and Needle Bevel Down Delivered to the Intradermal Layer of the Skin.|The proportion of saline injections administered with the ID Adapter with needle bevel oriented up and needle bevel oriented down resulting in delivery to the intradermal layer of the skin. This will be assessed by visualization of intradermal wheals with diameters ≥ 5mm, the volume of liquid injected, and confirmation of delivery to the intradermal layer by ultrasound.|1 day||||percentage of injections|Participants||Number
2685470|NCT01359111|Secondary|Proportion of Participants With Safety Events|The proportion of participants with safety events will be calculated for events occurring within 30 minutes and within 48 hours of injection.|2 days||||percentage of participants|||Number
2685471|NCT01359111|Primary|Proportion of Injections Delivered to the Intradermal Layer of the Skin|The proportion of saline injections via the ID Adapter resulting in delivery to the intradermal layer of the skin will be assessed by visualization of intradermal wheals with diameters ≥ 5mm, the volume of liquid injected, and confirmation of delivery to the intradermal layer by ultrasound.|1 day||||percentage of injections|Participants||Number
2685472|NCT01359046|Secondary|Risk of Urinary Tract Infections in Diabetics|Number of diabetic subjects diagnosed with a urinary tract infection within 6 weeks post surgery.|within 6 weeks post surgery||||Participants|||Count of Participants
2685479|NCT01358981|Secondary|C-Peptide Area Under the Effective Concentration Curve (AUEC)|C-Peptide area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 6 hours.|Part A: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 4, 5, 6 and 24 h post-dose|All participants who received study drug and had evaluable C-Peptide data. Each participant in group Part B, Study Periods (SP) 1, 2, 3-8.4 mg LY2881835 was dosed and had corresponding C-Peptide measures in 2 of the 3 SP in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment participants actually received.|||picomoles*hour/liter (pmol*h/L)|Samples|Standard Deviation|Mean
2685480|NCT01358981|Secondary|Glucagon-Like Peptide (Active GLP-1) Area Under the Effective Concentration Curve (AUEC)|Glucagon-like peptide (active GLP-1) area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 2.5 hours.|Part A: Predose, 1.5 and 2.5 h post-dose; Part B: Predose, 1.5 and 2.5 h post-dose|All participants who received study drug and had evaluable GLP-1 data. Each participant in group Part B, Study Periods (SP) 1, 2 and 3-8.4 mg LY2881835 was dosed and had corresponding GLP-1 measures in 2 of the 3 SP in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment participants actually received.|||picomoles*hour/liter (pmol*h/L)|Samples|Standard Deviation|Mean
2685481|NCT01358981|Secondary|Glucose Area Under the Effective Concentration Curve (AUEC)|Glucose area under the serum concentration versus time curve (AUEC) was calculated using the linear trapezoidal rule from time 0 to 24 hours.|Part A: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dose; Part B: Predose, 1.0, 1.5, 2.5, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 18 and 24 h post-dose|All participants who received study drug and had evaluable glucose data. Each participant in group Part B, Study Periods (SP) 1, 2 and 3-8.4 mg LY2881835 was dosed and had corresponding glucose measures in 2 of the 3 SP in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment participants actually received.|||milligrams*hour/deciliter (mg*hr/dL)|Samples|Standard Deviation|Mean
2685482|NCT01358981|Secondary|Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY2881835|Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only Tmax up to 24 hours post dose is provided.|Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose|All participants who received study drug and had evaluable PK data. Each participant in group Part B, Study Periods 1, 2 and 3 - 8.4 mg LY2881835 was dosed and had corresponding PK measures in 2 of the 3 study periods in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment the participants actually received.|||hours|Samples|Full Range|Median
2685483|NCT01358981|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax) Of LY2881835|Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only Cmax up to 24 hours post-dose is provided.|Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose|All participants who received study drug and had evaluable PK data. Each participant in group Part B, Study Periods 1, 2 and 3 - 8.4 mg LY2881835 was dosed and had corresponding PK measures in 2 of the 3 study periods in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment the participants actually received.|||nanograms/milliliter (ng/mL)|Samples|Geometric Coefficient of Variation|Geometric Mean
2685484|NCT01358981|Secondary|Pharmacokinetics (PK): Area Under the Curve (AUC) of LY2881835|Not all the participants had quantifiable plasma concentrations at 48 hours, therefore only AUC from time zero to 24 hours [AUC(0-24 hours)] is provided.|Part A: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24hours (h) post-dose; Part B: Predose, 0.5, 1.5, 2.5, 4, 6, 12, 18 and 24 h post-dose|All participants who received study drug and had evaluable PK data. Each participant in group Part B, Study Periods 1, 2 and 3 - 8.4 mg LY2881835 was dosed and had corresponding PK measures in 2 of the 3 study periods in Part B resulting in 18 samples being analyzed. Analysis used data according to the treatment the participants actually received.|||nanograms*hour/milliliter (ng*hr/mL)|Samples|Geometric Coefficient of Variation|Geometric Mean
2685485|NCT01358981|Primary|Number of Participants With Clinically Significant Adverse Effects|Clinically significant adverse effects are treatment emergent adverse events (TEAEs) possibly related to study drug.|Baseline to study completion up to 3 months|All enrolled participants who received study drug.|||participants|||Number
2685486|NCT01358968|Secondary|Number of Participants With a Tumor Response|Tumor response is complete response (CR) + partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1). CR is the disappearance of all target and non-target lesions and PR is a ≥30% decrease in sum of longest diameter of target lesions. Number of participants with a tumor response is the total number of participants with CR or PR.|Baseline to study completion up to 11 cycles of 21-day cycles|All participants who received at least 1 dose of study drug and had tumor response measured during continued access phase.|||Participants|||Count of Participants
2685487|NCT01358968|Primary|Plasma Pharmacokinetics of Desipramine: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Observed Plasma Concentration of Desipramine [AUC(0-tlast)]||Periods 1 and 2: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dose|All participants who received desipramine and had pharmacokinetic data collected to calculate AUC(0-tlast) of desipramine in Periods 1 and 2.|||nanogram*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2685488|NCT01358968|Primary|Plasma Pharmacokinetics of LY2603618: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Observed Plasma Concentration of LY2603618 [AUC(0-tlast)]||Period 2 only: Predose 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dose|All participants who received LY2603618 and had pharmacokinetic data collected to calculate the AUC(0-tlast) of LY2603618 in Period 2.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2685489|NCT01358968|Primary|Plasma Pharmacokinetics of Desipramine: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)]||Periods 1 and 2: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dose|All participants who received desipramine and had pharmacokinetic data collected to calculate the AUC(0-∞) of desipramine in Periods 1 and 2.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2688166|NCT01335932|Secondary|Incidence of CMV Reactivation >1,000 IU Per mL at Day 28 in Plasma|Number of participants with CMV reactivation >1,000 IU per mL at day 28 in plasma|at 28 days post-randomization||||Participants|||Count of Participants
2685490|NCT01358968|Primary|Plasma Pharmacokinetics of LY2603618: the Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)]||Period 2 only: Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dose|All participants who received LY2603618 and had pharmacokinetic data collected to calculate the AUC(0-∞) of LY2603618 in Period 2.|||nanograms*hour/milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2685491|NCT01358968|Primary|Plasma Pharmacokinetics of Desipramine: the Maximum Concentration of Desipramine in the Plasma (Cmax)||Periods 1 and 2: Predose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours post dose|All participants who received desipramine and had pharmacokinetic data collected to calculate the Cmax of desipramine in Periods 1 and 2.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2685492|NCT01358968|Primary|Plasma Pharmacokinetics of LY2603618: the Maximum Concentration of LY2603618 in the Plasma (Cmax)||Period 2 only: Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours post dose|All participants who received LY2603618 and had pharmacokinetic data collected to calculate the Cmax of LY2603618 in Period 2.|||nanograms/milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2685493|NCT01358877|Secondary|Cmax of Trastuzumab||Cycles 1, 10 and 15 (Cycle length=21 days)|PK evaluable participants. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||mcg/mL||Standard Deviation|Mean
2685494|NCT01358877|Secondary|Peak Serum Concentration (Cmax) of Pertuzumab||Cycles 1, 10 and 15 (Cycle length=21 days)|PK evaluable participants. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||mcg/mL||Standard Deviation|Mean
2685495|NCT01358877|Secondary|Cmin of Trastuzumab||Cycles 1, 10 and 15 (Cycle length=21 days)|PK evaluable participants. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||mcg/mL||Standard Deviation|Mean
2685496|NCT01358877|Secondary|Trough Serum Concentration (Cmin) of Pertuzumab||Cycles 1, 10 and 15 (Cycle length=21 days)|Pharmacokinetic (PK) evaluable participants were defined as those who received at least one active pertuzumab and/or trastuzumab treatment and had at least one PK sample collected. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||micrograms per milliliter (mcg/mL)||Standard Deviation|Mean
2685497|NCT01358877|Secondary|Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain|EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in anxiety/depression domain was reported: I am not anxious or depressed; I am moderately anxious or depressed; and I am extremely anxious or depressed. Response percentages may not add up to 100% due to data rounding.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||percentage of participants|||Number
2685498|NCT01358877|Secondary|Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain|EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in pain/discomfort domain was reported: I have no pain or discomfort; I have moderate pain or discomfort; and I have extreme pain or discomfort. Response percentages may not add up to 100% due to data rounding.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||percentage of participants|||Number
2685499|NCT01358877|Secondary|Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain|EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in usual activities domain was reported: I have no problems with performing my usual activities; I have some problems with performing my usual activities; and I am unable to perform my usual activities. Response percentages may not add up to 100% due to data rounding.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||percentage of participants|||Number
2685500|NCT01358877|Secondary|Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain|EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in self-care domain was reported: I have no problems with self-care; I have some problems washing or dressing myself; and I am unable to wash or dress myself. Response percentages may not add up to 100% due to data rounding.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||percentage of participants|||Number
2685501|NCT01358877|Secondary|Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain|EQ-5D-3L is a descriptive system of health-related quality of life states consisting of 5 dimensions/domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and each of which has 3 levels of severity (no problems [scored as 1], some or moderate problems [scored as 2], and extreme problems [scored as 3]). Percentage of participants with each of the following responses in mobility domain was reported: I have no problems in walking about; I have some problems in walking about; and I am confined to bed. Response percentages may not add up to 100% due to data rounding.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||percentage of participants|||Number
2703724|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|26 weeks|||||||
2685502|NCT01358877|Secondary|Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score|EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for symptom scale indicated high level of symptomatology/problems/greater degree of symptoms. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
2685503|NCT01358877|Secondary|Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score|EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and four symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Negative change from Baseline indicated deterioration in QOL and positive change from Baseline indicated an improvement in QOL.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||units on a scale||Standard Deviation|Mean
2685504|NCT01358877|Secondary|Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores|EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 financial difficulties scores were linearly transformed on a scale of 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicated improvement in financial difficulties and positive values indicated worsening of financial difficulties.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.|||units on a scale||Standard Deviation|Mean
2685505|NCT01358877|Secondary|Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores|EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 disease/treatment-related symptom scores were linearly transformed on a scale of 0 to 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicated improvement in symptoms and positive values indicated worsening of symptoms.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.|||units on a scale||Standard Deviation|Mean
2685506|NCT01358877|Secondary|Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores|EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall QOL in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, N/V, constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 functioning scores were linearly transformed on a scale of 0 to 100, with a high score indicating better functioning/support. Negative change from Baseline values indicated deterioration in functioning and positive values indicated improvement.|Baseline, Weeks 13, 25; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36|ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.|||units on a scale||Standard Deviation|Mean
2685517|NCT01358877|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Kaplan-Meier estimate of the percentage of participants who were DFS event-free at Year 3 is reported. DFS was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.|3 years|ITT population. Overall number of participants analyzed=participants remaining at risk for DFS event at Year 3.|||Estimate of percentage of participants||95% Confidence Interval|Number
2685685|NCT01357720|Primary|Seroprotection Rate: Anti-PRP Antibodies|Percentage of subjects with an anti-PRP titer ≥0.15 µg/mL (i.e. seroprotection rate)|1 month after the third vaccination|Available observations at Visit 4|||percentage of subjects||95% Confidence Interval|Number
2685507|NCT01358877|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score|EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting [N/V], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better GHS/QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.|Baseline, Weeks 13, 25; end of treatment (EOT, 28 days after the last dose, up to Week 56); Follow-up (FU) Months 18, 24, 36|ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.|||units on a scale||Standard Deviation|Mean
2685508|NCT01358877|Secondary|Change From Baseline in LVEF to Worst Post-Baseline Value|LVEF is the fraction of blood (in percent) pumped out of the heart's left ventricular chamber with each heart beat, and is a measure of cardiac output for the heart. Baseline LVEF value and the maximum absolute decrease (worst value) in LVEF measurement from baseline were reported. LVEF was measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.|Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)|Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=participants evaluable for this outcome measure at specified timepoint.|||percentage of blood pumped out||Standard Deviation|Mean
2685509|NCT01358877|Secondary|Percentage of Participants With Secondary Cardiac Event|Secondary cardiac event was defined as asymptomatic or mildly symptomatic (NYHA Class II) significant drop in LVEF (defined as an absolute decrease of at least 10 EF points from baseline and to below 50%), confirmed by a second LVEF assessment within approximately three weeks of the first significant LVEF assessment or confirmed by the Cardiac Advisory Board (CAB).|Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)|Safety population|||percentage of participants|||Number
2685510|NCT01358877|Secondary|Percentage of Participants With Primary Cardiac Event|Primary cardiac event was defined as either: Heart Failure (New York Heart Association [NYHA] Class III or IV) and a drop in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50 percent (%); or cardiac death. Cardiac death was defined as either definite cardiac death: due to heart failure, myocardial infarction, or documented primary arrhythmia; or probable cardiac death: sudden unexpected death within 24 hours of a definite or probable cardiac event (e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia) without documented etiology.|Baseline until data cut-off date 19 December 2016 (up to maximum length of follow-up of 59 months)|Safety population included participants who received any amount of study medication (chemotherapy, pertuzumab/placebo, or trastuzumab), according to the treatment actually received.|||percentage of participants|||Number
2685511|NCT01358877|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Kaplan-Meier estimate of the percentage of participants who were DRFI event-free at Year 3 is reported. DRFI event was defined as distant breast cancer recurrence.|3 years|ITT population. Overall number of participants analyzed=participants remaining at risk for DRFI event at Year 3.|||Estimate of percentage of participants||95% Confidence Interval|Number
2685512|NCT01358877|Secondary|Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Percentage of participants with DRFI event is reported. DRFI event was defined as distant breast cancer recurrence.|Randomization until distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)|ITT population|||percentage of participants|||Number
2685513|NCT01358877|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Kaplan-Meier estimate of the percentage of participants who were RFI event-free at Year 3 is reported. RFI event was defined as local, regional or distant breast cancer recurrence.|3 years|ITT population. Overall number of participants analyzed=participants remaining at risk for RFI event at Year 3.|||Estimate of percentage of participants||95% Confidence Interval|Number
2685514|NCT01358877|Secondary|Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Percentage of participants with RFI event is reported. RFI event was defined as local, regional or distant breast cancer recurrence.|Randomization until local, regional or distant breast cancer recurrence (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)|ITT population|||percentage of participants|||Number
2685515|NCT01358877|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at Year 3|The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 3 years.|3 years|ITT population. Overall number of participants analyzed=participants remaining at risk for death at Year 3.|||Estimate of percentage of participants||95% Confidence Interval|Number
2685516|NCT01358877|Secondary|Percentage of Participants Who Died|Percentage of participants who died due to any cause is reported.|Randomization until death due to any cause (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)|ITT population|||percentage of participants|||Number
2685527|NCT01358864|Secondary|AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES|The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline|End of treatment, up to 48 weeks|FAS|||participants|||Number
2685528|NCT01358864|Secondary|AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO|The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline|End of treatment, up to 48 weeks|FAS|||participants|||Number
2685518|NCT01358877|Secondary|Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Percentage of participants with DFS event is reported. DFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.|Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)|ITT population|||percentage of participants|||Number
2685519|NCT01358877|Secondary|Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (including SPNBC) at Year 3 is reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).|3 years|ITT population. Overall number of participants analyzed=participants remaining at risk for IDFS event (including SPNBC) at Year 3.|||Estimate of percentage of participants||95% Confidence Interval|Number
2685520|NCT01358877|Secondary|Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Percentage of participants with IDFS events (including SPNBC) is reported. IDFS-SPNBC event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).|Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)|ITT population|||percentage of participants|||Number
2685521|NCT01358877|Primary|Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at Year 3, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (excluding SPNBC) at Year 3 is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event.|3 years|ITT population. Overall number of participants analyzed=participants remaining at risk for IDFS event (excluding SPNBC) at Year 3.|||Estimate of percentage of participants||95% Confidence Interval|Number
2685522|NCT01358877|Primary|Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings|Percentage of participants with IDFS events (excluding SPNBC) is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (that is [i.e.], an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including ductal carcinoma in situ [DCIS] and lobular carcinoma in situ [LCIS]) and non-melanoma skin cancer were excluded as an event.|Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016, up to maximum length of follow-up of 59 months)|ITT population|||percentage of participants|||Number
2685523|NCT01358864|Secondary|AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES|The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline|12 weeks post treatment, up to 60 weeks|FAS|||participants|||Number
2685524|NCT01358864|Secondary|AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO|The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline|12 weeks post treatment, up to 60 weeks|FAS|||participants|||Number
2685525|NCT01358864|Secondary|ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES|The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline|12 weeks post treatment, up to 60 weeks|FAS|||participants|||Number
2685526|NCT01358864|Secondary|ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO|The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline|12 weeks post treatment, up to 60 weeks|FAS|||participants|||Number
2688602|NCT01332435|Primary|Number of Participants With Acute Urinary Retention|Acute urinary retention was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.|Day 1 of a 1-day study|Enrolled Population|||participants|||Number
2685529|NCT01358864|Secondary|ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES|The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline|End of treatment, up to 48 weeks|FAS|||participants|||Number
2685530|NCT01358864|Secondary|ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO|The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline|End of treatment, up to 48 weeks|FAS|||participants|||Number
2685531|NCT01358864|Primary|Sustained Virological Response 12 Weeks Post Treatment (SVR12)|Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.|12 weeks post treatment, up to 60 weeks|FAS|||percentage of participants||95% Confidence Interval|Number
2685532|NCT01358864|Secondary|Early Treatment Success (ETS)|Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level <25 IU/mL (undetected or detected) at Week 4 and <25 IU/mL (undetected) at Week 8.|Week 4 and Week 8|FAS|||percentage of participants|||Number
2685533|NCT01358864|Secondary|Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)|Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.|24 weeks post treatment, up to 72 weeks|FAS|||percentage of participants||95% Confidence Interval|Number
2685534|NCT01358825|Primary|Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/mL|Cut-off values assessed were greater than or equal to 6.2 milliinternational units per millilitre ( mIU/mL) in the sera of subjects seronegative before vaccination.|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.|||Subjects|||Number
2685535|NCT01358825|Primary|Number of Subjects With Serious Adverse Events (SAEs).|Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (up to Day 46)|The analysis was performed on the Total Cohort, which included all subjects enrolled in the study.|||Subjects|||Number
2685536|NCT01358825|Primary|Concentrations of Antibodies Against Anti-PRP.|Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per millilitre (μg/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.|||μg/mL||95% Confidence Interval|Geometric Mean
2685537|NCT01358825|Primary|Number of Seroprotected Subjects Against Anti-polyribosyl Ribitol Phosphate (Anti-PRP).|A seroprotected subject is a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.|||Subjects|||Number
2685538|NCT01358825|Primary|Concentrations of Antibodies Against Anti-HBs.|Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.|||mIU/mL||95% Confidence Interval|Geometric Mean
2685539|NCT01358825|Primary|Number of Seroprotected Subjects Against Anti-hepatitis B Surface Antigen (Anti-HBs).|Seroprotection = anti-HBs antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.|||Subjects|||Number
2685540|NCT01358825|Primary|Concentrations of Antibodies Against Anti-PT, Anti-FHA and Anti-PRN.|Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2685541|NCT01358825|Primary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Antifilamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations ≥5 ELISA Units Per Milliliter (EL.U/mL).|Cut-off values assessed were greater than or equal to 5 ELISA units per millilitre (EL.U/mL) in the sera of subjects seronegative before vaccination.|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.|||Subjects|||Number
2685542|NCT01358825|Primary|Concentrations of Antibodies Against Anti-D and Anti-T|Concentrations are presented as geometric mean concentrations (GMCs), expressed in milliinternational units per millilitre (mIU/mL).|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.|||IU/mL||95% Confidence Interval|Geometric Mean
2685543|NCT01358825|Primary|Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T).|A seroprotected subject is a subject with anti-D/anti-T antibody concentrations greater than (≥) or equal to 0.1 international units per milliliter (IU/mL)|At Day 0|The analysis was performed on the According-To-Protocol (ATP) Cohort, which included all subjects with blood sample available and who met all the eligibility criteria, complying with the procedure defined in the protocol and with no elimination code assigned.|||Subjects|||Number
2695944|NCT01274559|Secondary|Percent Change From Baseline in Non-HDL-C at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2685544|NCT01358760|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||Severity score||Standard Error|Mean
2685545|NCT01358760|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||Severity score||Standard Error|Mean
2685546|NCT01358760|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||Severity score||Standard Error|Mean
2685547|NCT01358760|Secondary|Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions|To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||Severity score||Standard Error|Mean
2685548|NCT01358760|Secondary|Change From Baseline to Week 12 in Severity of Dyspareunia|The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses on dyspareunia were performed on a subgroup of the Intent to Treat (ITT) population (defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria) who had self-identified moderate to severe dyspareunia at Baseline.|||Severity score||Standard Error|Mean
2685549|NCT01358760|Primary|Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness|The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||Severity score||Standard Error|Mean
2685550|NCT01358760|Primary|Change From Baseline to Week 12 in Vaginal pH|A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||pH units||Standard Error|Mean
2685551|NCT01358760|Primary|Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear|The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||percentage of superficial cells||Standard Error|Mean
2685552|NCT01358760|Primary|Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear|The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.|Baseline and Week 12|Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.|||percentage of parabasal cells||Standard Error|Mean
2685553|NCT01358734|Secondary|Number of Participants With a Second Primary Malignancy|Second primary malignancies were monitored as events of interest and reported as serious adverse events regardless of the treatment arm the participant was enrolled in.|From randomization of the last participant up to a minimum of 4 years following discontinuation|Safety population includes all participants who received at least one dose of IP|||Participants|||Number
2685554|NCT01358734|Primary|Overall Survival|Overall Survival reported at the end of the study are for those participants who were alive at the end of the study|From date of randomization until the date of the first documented date of progression or date of death of any cause; the overall median follow-up for survivng participants was 4.1 months (range 0.2 to 54.8 months)|Participants who were still alive at the end of the study and in safety population.|||months||Full Range|Median
2685555|NCT01358734|Other Pre-specified|Percentage of Participants Alive at One Year|Defined as the percentage of participants who survived at one year|Up to 12 months|ITT population included participants who were randomized.|||Percentage of participants||95% Confidence Interval|Number
2685556|NCT01358734|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAE)|TEAEs were defined as those events that started on or after the first day of study drug up until 28 days after the last dose of study drug; Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; constitutes an important medical event. Severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); and according to the scale: Grade (Gr) 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death|From the first dose of study drug up to 28 days after the last dose of study drug; up to 15 May 2018|Safety population includes all participants who have received at least 1 dose of Investigational Product.|||participants|||Number
2685557|NCT01358734|Secondary|Percentage of Participants With 30-Day Treatment-Related Mortality|30-day mortality rate was defined as death from any cause within 30 days after first dose.|30 days|ITT included all randomized participants.|||percentage of participants|||Number
2685558|NCT01358734|Secondary|Relapse-Free Survival (RFS)|RFS is defined only for subjects that achieve CR and CRi and is measured as the interval from that date to the date of disease relapse, death from any cause, whichever occurs first, censoring at the last visit date for subjects alive in continuous CR/CRi. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.|Relapse-Free survival time frame was not analyzed.|Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.||||||
2685559|NCT01358734|Secondary|Event-Free Survival (EFS)|EFS was defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after CR or CRi, or death from any cause, whichever occurred first. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.|Event-Free survival time was not analyzed.|Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.||||||
2685560|NCT01358734|Secondary|Progression-Free Survival (PFS)|PFS is defined as the time from randomization to the first observation of documented disease progression or death from any cause whichever occurred first. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.|Progression-Free survival data and time frame was not analyzed.|Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.||||||
2685561|NCT01358734|Secondary|Percentage of Participants With an Overall Response Rate (CR +CRi+ PR)|Morphologic complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a one marrow aspirate with spicules and with at least 200 nucleated cells (there should be no blasts with auer rods) and ANC of ≥ 1 x 10^9/L, a platelet count ≥ 100 x 10^9/L, no transfusions for 1 week prior to each assessment. No duration of these findings is required for confirmation of this response. Morphologic complete remission with incomplete blood count recovery was defined as a morphologic complete remission but the ANC may be < 1 x 10^9/L and/or the platelet count may be < 100 x 10^9/L. Partial remission was defined as an ANC > 1 x 10^9/L and platelet count ≥ 100 x 10^9/L with a > 50% decrease in the percentage of bone marrow blasts to 5% to 25% (a blast count value of ≤ 5% may also be considered a partial remission if auer rods are present). Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.|Overall response rate time frame was not analyzed.|Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.||||||
2685562|NCT01358734|Secondary|Cytogenetic Complete Remission Rate (CRc)|The CRc response category is comprised of the subset of participants who had abnormal cytogenetics at baseline and subsequently achieved CR during treatment in conjunction with a reversion to a normal karyotype. For the primary definition of CRc, a normal karyotype is defined as no clonal abnormalities after review of at least 10 metaphases using conventional cytogenetic techniques. Cytogenetic complete remission rate (CRc) 1) CR criteria met AND 2) Abnormal karyotype present at baseline AND 3) Reversion to normal karyotype at time of CR (based on ≥ 10 metaphases), where date of cytogenetic sample = date of BM sample used for the CR assessment. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.|Cytogenetic Complete Remission timeframe was not analyzed.|Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.||||||
2685563|NCT01358734|Secondary|Duration of Remission (DoR)|Duration of remission was defined as the time from the date of CR or CRi until relapse. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.|Duration of Remission (DoR) time frame not analyzed.|Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.||||||
2685564|NCT01358734|Secondary|Percentage of Participants With a Complete Response or Morphologic Incomplete Response.|"Based on IWG response criteria for AML. Complete remission (CR), morphologic complete remission (CR) was defined as < 5% bone marrow blasts, an absolute neutrophil count ≥ 1 x 10^9/L, platelets ≥100 x 10^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response.~Morphologic CR with incomplete blood count recovery (CRi) was defined as a morphologic complete remission but the ANC count may be <1 x 10^9/L and/or the platelet count may be <100 x 10^9/L. Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed."|Complete Response or Morphologic Incomplete Response data not analyzed.|Because of a high rate of discontinuation in one of the investigational cohorts, secondary endpoints were not analyzed.||||||
2685566|NCT01358721|Secondary|Immunogenicity of BMS-936558 as Measured by the Detection of Human Antibodies Against BMS-936558|Blood samples to evaluate the development of a positive anti-drug antibodies (ADA) response at the doses tested will be collected at time-points pre-dose, C4D1, C8D1 and during follow-up.|Pre-dose, Cycle 4 Day 1, Cycle 8 Day 1 and during follow-up.|"ADA-Positive Subject: A subject with at least one ADA-positive sample at any time after initiation of treatment.~ADA-Negative Subject: A subject with no ADA-positive sample after the initiation of treatment"|||percentage|||Number
2685567|NCT01358721|Secondary|Duration of Stable Disease for BMS-936558 as Measured in Participants Whose Best Overall Response is Stable Disease as the Time From Baseline Until the Date of Documented Disease Progression or Death|Duration of stable disease (SD) is defined in participants whose BOR is SD at the time from treatment arm assignment until the criteria for progression are met or death (whichever occurs first). Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last tumor assessment|The time from treatment arm assignment until the criteria for progression are met or death (whichever occurs first)(assessed up to 39 months)|All treated participants|||weeks||95% Confidence Interval|Median
2685568|NCT01358721|Secondary|Duration of Objective Response for BMS-936558|The duration of response is defined as the time when the measurement criteria are first met for PR or CR (whichever is reported first) until the date of documented disease progression or death. For subjects who neither progress nor die, the duration of response will be censored at the date of their last tumor assessment.|The time when the measurement criteria are first met for PR or CR (whichever is reported first) until the date of documented disease progression or death (assessed up to 39 months)|All treated participants|||weeks||95% Confidence Interval|Median
2685569|NCT01358721|Secondary|Objective Response Rate in BMS-936558|The total number of subjects whose best overall response (BOR) is either a complete response (CR) or partial response (PR) divided by the total number of participants in the population of interest, and expressed as a percentage.|Up to 22 months after study start|All treated participants|||percent||95% Confidence Interval|Number
2685570|NCT01358721|Secondary|Progression Free Survival Rate in BMS-936558|PFS is defined as the time from treatment arm assignment to the date of first documented disease progression. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last tumor assessment. Participants who did not have any on study tumor assessments will be censored on the date they were assigned a treatment arm. PFS rate is the percentage of participants who did not have disease progression at particular time points (16 weeks, 24 weeks, 48 weeks)|Progression free survival rate will be assessed in each individual treatment arm by tumor assessments at 16, 24, and 48 weeks. From initial dose to end of study (assessed up to 39 months)|All treated participants|||percent||95% Confidence Interval|Number
2685571|NCT01358721|Secondary|Best Overall Response in the BMS-936558 Arms|Baseline and post-nivolumab treatment modulation of serum levels of interferon-gamma stimulated chemokines CXCL9 and CXCL10 (IP10) were assessed. The participant's best response designation over the study as a whole, recorded between the date of first study drug administration and the date of objectively documented progression per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Assessed at a minimum of every 3 weeks up to 70 days following discontinuation of study drug (up to approximately 39 months)|All treated participants|||Participants|||Count of Participants
2685572|NCT01358721|Primary|Mean CD8 T Cell Infiltration|The objective of the study was to investigate the pharmacodynamic immunomodulatory activity of anti-PD-1 antibody on circulating CD8 infiltrations in tumors in participants with metastatic clear-cell Renal Cell Carcinoma (RCC).|168 hour post does Cycle 2 Day 8 in evaluable participates (First active dose of study medication to cycle two day eight post injection)|Biomarker evaluable population: All treated participants at least one measurement for a specific marker were included in the data set for that marker.|||Number of CD8 cells||Standard Deviation|Mean
2685573|NCT01358721|Primary|Mean CD4 T Cell Infiltration|The objective of the study was to investigate the pharmacodynamic immunomodulatory activity of anti-PD-1 antibody on circulating CD4 infiltrations in tumors in participants with metastatic clear-cell Renal Cell Carcinoma (RCC).|Cycle 2 Day 8 168 Hr post dose|Biomarker evaluable population: All treated participants with at least one measurement for a specific marker were included in the data set for that marker.|||Number of CD4+ Cells||Standard Deviation|Mean
2685574|NCT01358721|Primary|Mean Serum Cytokines CXCL10 (IP10)|Objective is to investigate the pharmacodynamic immunomodulatory activity of serum chemokines (CXCL9, CXCL10)|Baseline, Cycle 1 Day 1 3 Hrs Post, Cycle 1 Day 1 7 Hr Post, Cycle 1 Day 2 24 Hr Post, Cycle 2 Day 1 0 Hr Pre, Cycle 2 Day 8 168 Hrs Post, Cycle 4 Day 1 O Hr Pre (~39 months)|Biomarker evaluable population: All treated participants with at least one measurement for a specific marker were included in the data set for that marker.|||pg/mL||Standard Deviation|Mean
2685575|NCT01358721|Primary|Mean Serum Cytokines: CXCL9|Objective is to investigate the pharmacodynamic immunomodulatory activity of serum chemokines (CXCL9, CXCL10)|Baseline, Cycle 1 Day 1 3 Hrs Post, Cycle 1 Day 1 7 Hr Post, Cycle 1 Day 2 24 Hr Post, Cycle 2 Day 1 0 Hr Pre, Cycle 2 Day 8 168 Hrs Post, Cycle 4 Day 1 O Hr Pre (~39 months)|Biomarker evaluable population: All treated participants with at least one measurement for a specific marker were included in the data set for that marker.|||pg/mL||Standard Deviation|Mean
2685576|NCT01358721|Primary|Percent Change From Baseline in Activated and Memory T Cells|The objective of the study was to investigate the pharmacodynamic immunomodulatory activity of anti-PD-1 antibody in activated and memory T cells with metastatic clear-cell Renal Cell Carcinoma (RCC)|Baseline, Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 8, Cycle 2 Day 8, Cycle 4 Day 1|All participants in the biomarker data set with baseline measurement and at least one on treatment measurement were included in pharmacodynamic analyses.|||Percentage||95% Confidence Interval|Mean
2685577|NCT01358708|Secondary|Use of Rescue Medication During the Double-Blind and Open-Label Treatment Phases of the Study|Number of subjects using rescue medication (bisacodyl or loperamide) during each treatment phase of the study|8 weeks|Analysis conducted on the Intent-to-Treat population for both treatment phases|||participants|||Number
2703725|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|16 weeks|||||||
2685578|NCT01358708|Secondary|Stool Characteristics During the Open-Label Treatment Phase Using the BSFS|The Bristol Stool Form Scale (BSFS) score ranges from 1 to 7 from hard (score of 1) to watery (score of 7). Data are presented as the mean of daily assessments over a week.|Daily assessment|Analysis conducted on the Intent-to-Treat population defined as all subjects randomized to double-blind treatment and who subsequently entered the Open-Label Treatment Phase ; observed case (OC) data with no imputation made; baseline defined as the last non-missing assessment prior to the first dose of double-blind study medication|||units on a scale (from 1 to 7)||Standard Deviation|Mean
2685579|NCT01358708|Secondary|Symptom Severity During the Open-Label Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score|The IBS-SSS has five questions related to four domains: abdominal pain severity and duration, abdominal distension, dissatisfaction with bowel habit and quality of life. The IBS-SSS score ranges from 0 (best outcome) to 500 (worst outcome).|Weekly assessment (every 7 days)|Analysis conducted on the Intent-to-Treat population defined as all subjects randomized to double-blind treatment and who subsequently entered the Open-Label Treatment Phase; observed case (OC) data with no imputation made; baseline defined as the last non-missing assessment prior to the first dose of double-blind medication.|||units on a scale (from 0 to 500)||Standard Deviation|Mean
2685580|NCT01358708|Secondary|Hospital Anxiety and Depression Scale (HADS) Score During the Double-Blind Phase|The HADS has 14 questions related to 2 domains: Anxiety subscale (7 questions) and Depression subscale (7 questions). Each question is graded from 0 (best outcome) to 3 (worst outcome), for a total score ranging from 0 (best outcome) to 42 (worst outcome).|At Screening and End of Double-Blind Treatment Phase|Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made|||units on a scale (from 0 to 42)||Standard Deviation|Mean
2685581|NCT01358708|Secondary|Stool Characteristics During the Double-Blind Treatment Phase Using the Bristol Stool Form Scale|The Bristol Stool Form Scale score ranges from 1 to 7 from hard (score of 1) to watery (score of 7). Data are presented as the mean of daily assessments over a week.|Daily assessment|Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made. Number of participants analyzed refers to number of participants at Baseline.|||units on a scale (from 1 ato 7)||Standard Deviation|Mean
2685582|NCT01358708|Secondary|Symptom Severity During the Double-Blind Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score|The IBS-SSS has five questions related to four domains: abdominal pain severity and duration, abdominal distension, dissatisfaction with bowel habit and quality of life. The IBS-SSS score ranges from 0 (best outcome) to 500 (worst outcome).|Weekly assessment (every 7 days)|Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made. Number of participants analyzed refers to number of participants at Baseline.|||units on a scale (from 0 to 500)||Standard Deviation|Mean
2685583|NCT01358708|Secondary|Global Assessment of Relief During the Open-Label Treatment Phase Using the Subject Global Assessment (SGA)|"Subjects were considered as responders if they had answered Yes to the following question at least 50% of the time during the 4-week treatment phase: Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?"|Weekly Assessment (every 7 days)|Analysis conducted on the Intent-to-Treat population defined as all subjects randomized to double-blind treatment and who subsequently entered the Open-Label Treatment Phase; observed case (OC) data with no imputation made; SGA data not available for one patient so that the analysis was performed on 16 rather than 17 patients|||percentage of participants|||Number
2685584|NCT01358708|Primary|Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA)|"Subjects were considered as responders if they had answered Yes to the following question at least 50% of the time during the 4-week treatment phase: Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?"|Weekly Assessment (every 7 days)|Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made|||percentage of participants|||Number
2685585|NCT01358578|Secondary|Number of Participants Developing Anti-secukinumab Antibodies|Describes the number of participants tested positive for anti-secukinumab antibodies. It refers to the number of patients who had no positive values at baseline but developed them only after start of active study treatment (AIN457 or etanercept)|60 weeks|Full Analysis Set|||# participants tested positive|||Number
2685586|NCT01358578|Secondary|Change From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Etanercept|The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy|baseline to week 12|Full analysis set|||Units on a scale||Standard Error|Mean
2685587|NCT01358578|Secondary|Change in Score From Baseline to Week 12 in Psoriasis Symptom Diary Items Itching, Pain and Scaling in AIN457 vs Placebo|The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.Weekly averages will be derived for each of the 16 questions of the Psoriasis Diary up to Week 12. A weekly average is the sum of the scored item over the course of the study week divided by the number of days on which the item was completed and will be set to missing if four or more daily assessments were missing of the corresponding question. The range for each question is 0 to 10 with the higher score depicting a more progressed disease state. A reduction in score from baseline shows efficacy|baseline to week 12|Full analysis set|||units on scale||Standard Error|Mean
2703726|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|14 weeks|||||||
2685590|NCT01358578|Secondary|Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: :IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12|The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.|12 wks|FAS|||participant acheiving goal|||Number
2685591|NCT01358578|Secondary|Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 at Week 12|A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis|12 wks|FAS|||participant who acheived goal|||Number
2685592|NCT01358578|Secondary|Efficacy of Secukinumab Compared to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 90 at Week 12|A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above current benchmark of primary endpoints for most clinical trials of psoriasis|12 wks|FAS|||participant who acheived goal|||Number
2685593|NCT01358578|Primary|Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12|The IGA mod 2011 scale has been developed based on a previous version of the scale used in secukinumab phase II studies in collaboration with health authorities, in particular the FDA. The explanations/descriptions of the points on the scale have been improved to ensure appropriate differentiation between the points. The IGA mod 2011 used in this study is static, i.e. it refers exclusively to the subject's disease state at the time of the assessments, and does not attempt a comparison with any of the subject's previous disease states, whether at baseline or at a previous visit.IGA mod 2011 has a scale of 0-4 with the lower scores correlating to better performance. A score of 0= clear skin, 1= almost clear skin, 2=mild, 3=moderate,4=severe.|12 wks||||participants acheiving goal|||Number
2685594|NCT01358578|Primary|Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) .|A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials of psoriasis|12 wks||||participants achieving goal|||Number
2685595|NCT01358526|Other Pre-specified|Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline|"A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the average pain over the last 24 hours score for week 12 of the double-blind period."|Week 12|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||participants (responders)|||Number
2685596|NCT01358526|Other Pre-specified|Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline|"A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the average pain over the last 24 hours score for week 12 of the double-blind period."|Week 12|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||participants (responders)|||Number
2685597|NCT01358526|Secondary|Patient Global Impression of Change (PGIC)|"The PGIC observational scale was completed by the subject. Subjects were asked to assess the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse), where 1 = very much improved and 7 = very much worse. The proportion of subjects responding much improved and very much improved was summarized by treatment group and compared between groups using an exact test."|Week 12|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||participants (responders)|||Number
2685598|NCT01358526|Secondary|The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12|The scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep, 3 somnolence, 1 snoring, 1 shortness of breath). Only Sleep Disturbance Subscale questions 1, 3, 7, and 8 were analyzed; scores range from 0 to 100, where higher scores indicate greater sleep disturbance.|Weeks 4, 8, and 12|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||units on a scale||95% Confidence Interval|Mean
2685599|NCT01358526|Primary|"The Average Pain Over the Last 24 Hours at Week 12 of the Double-blind Period"|"The average pain over the last 24 hours score was collected using an 11-point numerical rating scale ranging from 0 to 10; where 0=no pain and 10=pain as bad as you can imagine."|24 hours (Week 12)|The full analysis population for efficacy (N = 600) was the group of subjects who were randomized and received at least 1 dose of double-blind study drug|||units on a scale (0 - 10)||Standard Error|Mean
2685600|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in Q-LES-Q-SF Percent Maximum Possible Score|The Q-LES-Q-SF is a 16-item self-report measure of the degree of enjoyment and satisfaction in various areas of daily living. The questionnaire was developed and validated for use in depressed outpatient subjects and has eight summary scales that reflect major areas of functioning: physical health, mood, leisure time activities, social relationships, general activities, work, household duties and school/coursework. Each item is rated on a 5-point scale, ranging from 1 (very poor) to 5 (very good). The Q-LES-Q-SF percentage maximum possible score is calculated as 100 × (Raw Score - 14 [Minimum Score]) / (70 [Maximum Score] - 14 [Minimum Score]). Higher percent maximum scores indicate better quality of life.|Double-blind Baseline to week 28|ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 12 lurasidone + Li/VPA subjects and 11 placebo +Li/VPA subjects did not have post-DB baseline Q-LES-Q-SF percent maximum possible score.|||units on a scale||Standard Error|Least Squares Mean
2685601|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in PIRS-2 Total Score|The PIRS-2 is a 2-item self-report of insomnia assessed via a computer interface. Each item is scored from 0-3. The PIRS-2 total score is calculated as the sum of the 2 items. The PIRS total score ranges from 0 to 6. Higher scores are associated with greater severity of insomnia.|Double-blind Baseline to week 28|ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 7 lurasidone + Li/VPA subjects and 7 placebo +Li/VPA subjects did not have post-DB baseline PIRS-2 total score.|||units on a scale||Standard Error|Least Squares Mean
2685602|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in SDS Total Score|The SDS is a composite of three self-rated items designed to measure the extent to which three major sectors in the patient's life are impaired by depressive symptoms. The SDS total score is calculated as the sum of the 3 items. The SDS total score ranges from 0 to 30. Higher scores are associated with greater severity of global functional impairments. If a subject has not worked/studied at all during the past week for reasons unrelated to the disorder, the SDS total score will be set to missing.|Double-blind Baseline to week 28|ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on treatment they were randomized. 63 lurasidone + Li/VPA subjects and 57 placebo +Li/VPA subjects did not have post-DB baseline SDS total score.|||units on a scale||Standard Error|Least Squares Mean
2685603|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOF) in PANSS Positive Symptom (PANNS-P) Subscale Score|The PANSS-P is a subset of items in the PANSS, an interview-based measure of the severity of psychopathology in adults with psychotic disorders. The measure contains seven questions to assess delusions, conceptual disorganization, hallucinations behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. An anchored Likert scale from 1-7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. The PANSS-P subscale score is the sum of the 7 items and ranges from 7 through 49. A higher score is associated with greater illness severity.|Double-blind Baseline to week 28|ITT Population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 6 lurasidone + Li/VPA subjects and 3 placebo +Li/VPA subjects did not have post-DB baseline PANSS-P score.|||units on a scale||Standard Error|Least Squares Mean
2685604|NCT01358357|Secondary|Change Fro Double-blind Baseline to Week 28 (LOCF) in QIDS-SR(16) Total Score|The QIDS-SR16 is a 16-item self-report measure of depressive symptomatology which uses a computerized assessment interface for administration. The scoring system for the QIDS-SR16 converts responses to 16 separate items into nine DSM-IV symptom criterion domains. The nine domains comprise: depressed mood (Item 5); concentration/decision making (Item 10); self outlook (Item 11); suicidal ideation (Item 12); decreased interest (Item 13); decreased energy (Item 14); sleep disturbance (initial, middle, and late insomnia or hypersomnia) (highest score of Items 1 to 4); appetite/weight disturbance (highest score of Items 6 to 9); and psychomotor disturbance (highest score of Items 15 and 16). The QIDS-SR16 total score is calculated as the sum of the 9 domain scores. The QIDS-SR16 total score ranges from 0 to 27 with a high score indicating more severe symptoms.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 7 lurasidone + Li/VPA subjects and 7 placebo +Li/VPA subjects did not have post-DB baseline QIDS-SR16 total score.|||units on a scale||Standard Error|Least Squares Mean
2685605|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in MADRS Total Score|The MADRS consists of 10 items, each rated on a Likert scale, from 0=Normal to 6=Most Severe. The MADRS total score is calculated as the sum of the 10 items. The MADRS total score ranges from 0 to 60. Higher scores are associated with greater severity of depressive symptoms.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 2 lurasidone + Li/VPA subjects did not have post-DB baseline MADRS total score.|||units on a scale||Standard Error|Least Squares Mean
2685606|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in YMRS Total Score|the YMRS is an 11-item instrument used to assess the severity of mania in subjects with a diagnosis of bipolar disorder. Ratings are based on patient self-reporting, combined with clinician observation (accorded greater score). The YMRS total score is calculated as the sum of the 11 items. The YMRS total score ranges from 0 to 60. Higher scores are associated with greater severity of maia.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 2 lurasidone + Li/VPA subjects did not have post-DB baseline YMRS total score.|||units on a scale||Standard Error|Least Squares Mean
2685607|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in CGI+-BP-S Depression Score|The CGI-BP-S depression score is a single value, clinician-rated assessment of depression illness severity and ranges from 1=Normal, not at all ill to 7=Among the most extremely ill patients. A higher score is associated with a greater illness severity.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 2 lurasidone + Li/VPA subjects did not have post-DB baseline CGI-BP-S depression score.|||units on a scale||Standard Error|Least Squares Mean
2685608|NCT01358357|Secondary|Change From Double -Blind Baseline to Week 28 (LOCF) in CGI-BP-S Mania Score|The CGI-BP-S mania score is a single value, clinician-rated assessment of mania illness severity and ranges from 1=Normal, not at all ill to 7=Among the most extremely ill patients. A high score is associated with greater illness severity|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. . 2 lurasidone + Li/VPA subjects did not have post-DB baseline CGI-BP-S mania score.|||units on a scale||Standard Error|Least Squares Mean
2685630|NCT01357980|Secondary|Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure|Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.|Baseline|Analysis based on number of subjects in the Safety population with a valid value.|||mm||Standard Deviation|Mean
2685609|NCT01358357|Secondary|Change From Double-blind Baseline to Week 28 (LOCF) in CGI-BP-S Overall Score|The CGI-BP-S overall score is a single value, clinician-rated assessment of overall bipolar illness severity and ranges from 1=Normal, not at all ill, to 7=Among the most extremely ill patients. a higher score is associated with greater illness severity.|Double-blind Baseline to week 28|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized. 2 lurasidone + Li/VPA subjects did not have post-DB baseline CGI-BP-S overall score.|||units on a scale||Standard Error|Least Squares Mean
2685610|NCT01358357|Secondary|Percentage of Subjects Who Experience a Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode||28 weeks|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.|||percentage of participants|||Number
2685611|NCT01358357|Secondary|Time to Recurrence of a Manic, Mixed Manic, Hypomanic, or Depressed Episode||28 weeks (up to 33 weeks)|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.|||Days||95% Confidence Interval|Median
2685612|NCT01358357|Secondary|Time to All-cause Discontinuation||28 weeks (up to 33 weeks)|ITT population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.|||Days||95% Confidence Interval|Median
2685613|NCT01358357|Primary|Time to Recurrence of Mood Event During the Double Blind Treatment Phase|"A mood event is defined as one of the following during the double-blind phase:~(1) Fulfilled Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision (DSM-IV-TR) criteria for manic, mixed manic, hypomanic, or depressive episode. (2) Required treatment intervention for manic, mixed manic, hypomanic, or depressive symptoms with any antipsychotic (other than study drug), antidepressant, mood stabilizer (other than lithium or divalproex), anxiolytic agents, benzodiazepine (beyond dosage allowed for anxiety, agitation, or insomnia). (3) Psychiatric hospitalization for any bipolar mood episode. (4) Young Mania Rating Scale (YMRS) or Montgomery-Asberg Depression Rating Scale (MADRS) total score ≥ 18 or Clinical Global Impression Bipolar Version, Severity of Illness (CGI BP S) score ≥ 4 at 2 consecutive assessments no more than 10 days apart. (5) Discontinuation from the study because of a mood event (as determined by the Investigator)."|28 weeks (up to 33 weeks)|ITT (Intent to treat) population: all subjects who were randomized and received at least one dose of study medication in the double-blind phase. Subjects were analyzed based on the treatment they were randomized.|||Days||95% Confidence Interval|Median
2685614|NCT01358331|Primary|Number of Participants With Overall Response Rate|Overall Response rate is defined as the number of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.|Baseline, and every 8 weeks until disease progression or discontinuation from study up to approximately 10 months|"The analysis population is defined as all participants who received at least 1 dose of MK-8353 and had at least 1 post-baseline efficacy assessment. Participants who received at least one dose but had no post-baseline assessment were counted as not evaluable and were not included in this analysis."|||Participants|||Number
2685615|NCT01358331|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|DLT was derived from the toxicities observed during the first cycle (28 days) for each dose level. DLT is defined as any hematologic or non-hematologic toxicity ≥Grade 3 as pre-specified per protocol, or drug-related toxicity, regardless of Common Terminology Criteria for Adverse Events (CTCAE) grade that causes >20% of the intended total number of doses in Cycle 1 to be missed.|Cycles of 28 days, up to approximately 9 months treatment and a 30-day follow-up period for a total time of up to approximately 10 months|Analysis population includes all participants who received at least one dose of MK-8353 and completed Cycle 1 of Part 1 or discontinued due to toxicity. Participants who discontinued treatment due to reasons other than toxicity were not included.|||Participants|||Number
2685616|NCT01358266|Other Pre-specified|VH 0 or 0.5+ Response at Month 6: Having a VH Score of 0 or 0.5+ at Month 6 (Modified SUNscale)|"At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)~Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+~Moderate blurring of the optic nerve head~Marked blurring of the optic nerve head~Optic Nerve head not visible"|Day1/Baseline and Day180/Month 6||||Participants|||Count of Participants
2685617|NCT01358266|Other Pre-specified|VH 0 or 2-unit Response at Month 6: Having a VH Score of 0 or a Decrease (Improvement) of at Least 2 Units From Baseline in VH Score at Month 6 (Modified SUN Scale)|"At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)~Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+~Moderate blurring of the optic nerve head~Marked blurring of the optic nerve head~Optic Nerve head not visible"|Day1/Baseline and Day180/Month 6||||Participants|||Count of Participants
2685618|NCT01358266|Other Pre-specified|VH 0 Response at Month 6: Having a VH Score of 0 at Month 6 (Modified SUN Scale)|"At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification~Vitreous Haze Scale Description VH score 0 = No inflammation"|Day1/Baseline and Day180/Month 6||||Participants|||Count of Participants
2685619|NCT01358266|Secondary|VH 0 or 0.5+ Response: Having a VH Score of 0 or 0.5+ at Month 5 (Modified SUN Scale)|At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Description VH score 0.5+=Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)|Day1/Baseline and Day150/Month 5||||Participants|||Count of Participants
2685620|NCT01358266|Secondary|VH 0 or 2-unit Response: Having a Reduction (Improvement) of at Least 2 Units From Baseline in VH Score or a VH Score of 0 at Month 5 (Modified SUN Scale)|"At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification Vitreous Haze Scale Step Description 0 No inflammation 0.5+ Trace Inflammation (slight blurring of the optic disc margins and or loss of nerve fiber layer reflex)~Mild blurring of the retinal vessels and optic nerve 1.5+ Optic nerve head and posterior retina view obstruction greater than 1+ but less than 2+~Moderate blurring of the optic nerve head~Marked blurring of the optic nerve head~Optic Nerve head not visible"|Day1/Baseline and Day150/Month 5||||Participants|||Count of Participants
2685621|NCT01358266|Primary|The Primary Endpoint, VH 0 Response, Was Defined as Having a VH Score of 0 at Month 5|"At each visit, slit-lamp biomicroscopy was used to assess VH and opacification. For slit-lamp biomicroscopy, a contact or non-contact lens could have been used. The modified SUN scale for VH was used to measure VH and opacification~Vitreous Haze Scale Description VH score 0 = No inflammation"|Day1 (Baseline) and Month 5 (Day150)||||Participants|||Count of Participants
2685622|NCT01358175|Secondary|Assessment of Responders for ASAS Partial Remission|ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale of 10. In this study ASAS partial remission is used to assess the efficacy of at least one dose of secukinumab versus placebo.ASAS partial remission was defined as a VAS score of less than 2 units in each of the 4 domains of ASAS 20: participant global assessment, pain (total back pain), function and inflammation. The percentages of participants who achieved ASAS partial remission were calculated.|16 weeks||||% responders|||Number
2685623|NCT01358175|Secondary|Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire / ASQoL|ASQoL is an 18 item questionnaire that assesses disease-specific quality of life (QoL), consisting of statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). In this study, ASQoL is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.|baseline and 16 weeks||||units on a scale||Standard Error|Least Squares Mean
2685624|NCT01358175|Secondary|Change From Baseline in Physical Function Component of the Short-form Health Survey / SF-36 PCS|SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both phyically and emotionally based. Two overall summary scores, the Phyical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|baseline, 16 weeks||||units on a scale||Standard Error|Least Squares Mean
2685625|NCT01358175|Secondary|Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index / BASDAI|"BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating no problem and 10 indicating  worst problem), to characterize six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI is used to assess the efficacy of at least one dose of secukinumab verus placebo. To give each symptom equal weighting, the mean (average) of the two scores relating to morning stiffness is taken. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 BASDAI score. Scores of 4 or greater suggest suboptimal control of disease, and patients with scores of 4 or greater are usually good candidates for either a change in their medical therapy or for enrollment in clinical trials evaluating new drug therapies directed at Ankylosing Spondylitis."|Baseline and 16 weeks||||units on scale||Standard Error|Least Squares Mean
2685626|NCT01358175|Secondary|Assessment of Responders for the SpondyloArthritis International Society ASAS 5/6 Response|ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevent to AS and no worsening in the remaining domain. In this study, ASAS 5/6 is used to assess the efficacy of at least one dose of secukinumab against placebo.|16 weeks||||% responders|||Number
2685627|NCT01358175|Secondary|Change From Baseline in Serum hsCRP|The change from baseline in hsCRP is expressed as a ratio of post-baseline to baseline values. With the ratio normalized to 1.0 at baseline, ratios less than 1.0 represent decreased postbaseline values, whereas ratios greater than 1.0 represent increased post-baseline values.|Base line and Week 16|FAS. Analysis was done on the log(e) ratio of the treatment value vs. baseline value to normalize the distribution of the hsCRP at each visit. LS Mean, SE, 95% CI and p-value are from mixed-effect model repeated measures (MMRM) with treatment, visit, TNF-alpha inhibitor status as factors, log(e) baseline and weight as covariates.|||ratio||Standard Error|Least Squares Mean
2685628|NCT01358175|Secondary|Assessment of Responders for the SpondyloArthritis International Society ASAS 40 Response|ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 40 is used to assess the efficacy of at least one dose of secukinumab against placebo.|16 weeks|FAS comprised all patients who were randomized and to whom study treatment had been assigned. The efficacy analyses are based on the FAS.|||% responders|||Number
2685629|NCT01358175|Primary|Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response|ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.|16 weeks|FAS comprised all patients who were randomized and to whom study treatment had been assigned. The efficacy analyses are based on the FAS.|||% responders|||Number
2685631|NCT01357980|Secondary|Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection|Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain.|Baseline|Analysis based on number of subjects in the Safety population with a valid value.|||mm||Standard Deviation|Mean
2685632|NCT01357980|Secondary|Quality of Life (QoL) Total Summary Score|"Mean Change from Baseline in Short Form (SF)-Qualiveen Questionnaire Calculated Total Score.~The SF-Qualiveen questionnaire is a specific health related QoL questionnaire validated for urinary disorders in subjects with neurological conditions containing 8 items looking at four scales: limitations (2 items); constraints (2 items); fears (2 items) and feelings (2 items). The 8 items each having a 5-point Likert-type scale ranging from 0=Not at all to 4=Extremely for the first 6 items, from 0=Never to 4=Always for item 7 and from 0=Always to 4=Never for item 8. The score per scale has been calculated as the mean of the two items. In case of one missing item among the 2 items for a given scale, the score has not been calculated.~Total score has been calculated as the mean of all the items completed among the 8 items.~Lower scores indicate a better QoL (i.e. no limitations, fears, constraints, or negative feelings) and higher scores indicate poorer QoL."|Baseline, 14, 42 and 84|Analysis based on number of subjects in the Intent to Treat (ITT) population.|||score on a scale||Standard Deviation|Mean
2685633|NCT01357980|Secondary|Physician's Global Assessment Score of Treatment Response|The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.|Day 84|Analysis based on number of subjects in the Intent to Treat (ITT) population.|||participants|||Number
2685634|NCT01357980|Secondary|Physician's Global Assessment Score of Treatment Response|The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.|Day 42|Analysis based on number of subjects in the Intent to Treat (ITT) population.|||participants|||Number
2685635|NCT01357980|Secondary|Physician's Global Assessment Score of Treatment Response|The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'.|Day 14|Analysis based on number of subjects in the Intent to Treat (ITT) population.|||participants|||Number
2685636|NCT01357980|Secondary|Urodynamics:Maximum Detrusor Pressure|Maximum Detrusor Pressure is an urodynamic parameter that is the maximum value of the pressure within the bladder which is measured during the filling phase of the urodynamic exam. Baseline urodynamics exams done at screening visit.|Baseline, Days 14, 42 and 84|Analysis based on number (n) of subjects with a valid value in the Intent-to-Treat (ITT) population for the respective treatment groups.|||cm water (cm H20)||Standard Deviation|Mean
2685637|NCT01357980|Secondary|Urodynamics: Maximum Cystometric Capacity|Maximum Cystometric Capacity is an urodynamic parameter that indicates the volume at which a patient feels he (she) can no longer delay release of urine from the urinary bladder. Baseline urodynamics exams done at screening visit.|Baseline, Days 14, 42 and 84|Analysis based on number (n) of subjects with a valid value in the Intent-to-Treat (ITT) population for the respective treatment groups.|||mL||Standard Deviation|Mean
2685638|NCT01357980|Primary|Daily Incontinence Episode Frequency (IEF)||Baseline and Day 84|Analysis based on number of subjects in the Intent to Treat (ITT) population.|||episodes per day||Standard Deviation|Mean
2685639|NCT01357915|Secondary|Assessment of CMV Infection by CMV Specific Desoxyribonucleic Acid (DNA) in Viral Load|CMV DNA viral loads were assessed using quantitative Polymerase Chain Reaction (qPCR). Data were presented for subjects included in the Vaccine group (GSK149203A S- Group).|At Month 48 and Month 60|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2685640|NCT01357915|Secondary|Number of Subjects With Response for Anti-CMV Tegument IgG Antibodies|CMV infection was determined by the anti-CMV proteins antibody response, using ELISA. Data were collected for all subjects at Month 48 (M48) and Month 60 (M60) in the Vaccine group (GSK149203A S- Group). All subjects from the Reference group (GSK149203A S+ Group) were positive for the anti-CMV tegument IgG antibodies at the screening visit.|At Month 48 and Month 60|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Participants|||Count of Participants
2685641|NCT01357915|Secondary|Desciptive Statistics on the Frequency of gB-specific Memory B-cells (by ELISPOT)|Memory B cells specific to the CMV gB antigen, as assessed by the Enzyme-linked Immunosorbent Spot (ELISPOT) method, were expressed as a frequency of the specific memory B-cells per million memory B-cells. Data were collected for all subjects at Month 48 (M48) and Month 60 (M60).|At Month 48 and Month 60|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||B cells/million cells||Inter-Quartile Range|Median
2685642|NCT01357915|Secondary|Descriptive Statistics on the Frequency of gB-specific Cluster of Differentiation (CD4+/CD8+) T-cells Expressing at Least Two Immune Markers|Among the immune markers determined by the Intracellular cytokine staining (ICS) were Interferon-gamma (INF-γ), Interleukin-2 (IL-2), Tumor necrosis factor-alpha (TNF-α), and CD40-Ligand (CD40-L). Data were collected for all subjects at Month 48 (M48) and Month 60 (M60).|At Month 48 and Month 60|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||T cells/million cells||Inter-Quartile Range|Median
2685643|NCT01357915|Secondary|Descriptive Statistics on Avidity Index (%) of Anti-gB IgG Antibodies|"Avidity for anti-gB IgG antibodies was assessed by the ELISA Avidity index method in all subjects, at Month 48 (M48) and Month 60 (M60).~This assay has been developed according to Souza et al (Rev.Inst.med.Trop.S.Paulo 45;323-326; 2003) using an elution step with urea to remove low-avidity antibodies from CMV antigen. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes are exposed to urea divided by the mean absorbance of reactions in which the immune complexes are not exposed to urea, expressed as a percentage."|At Month 48 and Month 60|The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||Avidity Index percentage||Inter-Quartile Range|Median
2685644|NCT01357915|Primary|Number of Subjects With Neutralizing Response Against Anti-Cytomegalovirus (CMV) Antibodies|The neutralizing antibodies were to be measured using an in-house micro-neutralization assay.|At Month 48 and Month 60|The persistence of the functional antibodies for Month 48 and Month 60 could not be analysed, due to the general deterioration of CMV-001/CMV-008 samples.||||||
2685645|NCT01357915|Primary|Concentrations of Antibodies Against Anti-Glycoprotein B (gB) Immunoglobulin G (IgG)|Anti-gB IgG antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL), as assessed by Enzyme-linked Immunosorbent Assay (ELISA). Data were collected at Month 48 (M48) and Month 60 (M60) from all subjects.|At Month 48 and Month 60|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2685646|NCT01357889|Primary|Maximum Observed Plasma Concentration (Cmax) of Albiglutide in the BE Phase|To assess the bioequivalence of the two formulations of study drug, an analysis of variance (ANOVA) model with treatment as a fixed effect was applied to the natural-log-transformed parameter Cmax estimated from the BE phase. The Process 2 treatment group (albiglutide derived from process 2) was the reference group and was compared with the Process 3 treatment group (albiglutide derived from process 3) as the test group (i.e., treatment comparisons based on the ratio of Process 3:Process 2). Blood samples for pharmacokinetic analysis were collected prior to dosing at Baseline and 24 hours (hr), 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2685647|NCT01357889|Primary|Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to Infinity (0-inf) of Albiglutide in the Bioequivalence (BE) Phase|To assess the bioequivalence of the two formulations of albiglutide, an analysis of variance (ANOVA) model with treatment as a fixed effect was applied to the natural-log-transformed parameter AUC(0-inf) estimated from the BE Phase. AUC is a measure of how much albiglutide is in the blood at certain time points. The Process 2 treatment group (albiglutide derived from process 2) was the reference group and was compared with the Process 3 treatment group (albiglutide derived from process 3) as the test group (i.e., treatment comparisons based on the ratio of Process 3:Process 2). Blood samples for pharmacokinetic analysis were collected prior to dosing at Baseline and 24 hours (hr), 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hours (hr), 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide Pharmacokinetic (PK) Population: all participants who had sufficient samples to calculate PK parameters of albiglutide. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.|||nanograms*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
2685648|NCT01357889|Secondary|Number of Participants With a Change From Baseline of Clinical Concern in Electrocardiogram (ECG) Values by Any On-therapy Visit|ECG parameters include heart rate, QRS interval, QTinterval, QT interval - Bazett correction (QTcB), QT interval - Fridericia correction (QTcF), RR interval, and PR interval. Criteria for values of potential concern were determined by the medical monitors. For the QRS interval, an increase of >25% when Baseline QRS >100 milliseconds (msec) and an increase of >50% when Baseline QRS <=100 msec was considered to be of clinical concern. For QTcF, a >=60 msec change from Baseline was considered to be of clinical concern. For the PR interval, an increase of >25% when Baseline PR >200 msec and an increase of >50% when Baseline PR <=200 msec was considered to be of clinical concern.|Week 1 through Week 25|Safety Population. Only those participants available at the specified time points were analyzed. Different par. may have been analyzed at different time points; the overall number of par. analyzed reflects everyone in the Safety Population.|||Participants|||Number
2685649|NCT01357889|Secondary|Number of Participants With the Indicated Change From the Screening Assessment in Physical Examination at Week 17|A complete physical examination was performed at Screening and at Week 17 and included evaluation of the following organ or body systems: skin (including injection site); head; eyes; ears, sose, and throat (ENT); thyroid; respiratory system; cardiovascular system; abdomen (liver, spleen); lymph nodes; central nervous system (CNT); and extremities. The assessment was categorized as improved, no change, worsened, and not done.|Screening and Week 17|Safety Population. Only participants analyzed at Week 17 are presented.|||Participants|||Number
2685650|NCT01357889|Secondary|Number of Participants With a Change From Baseline of Clinical Concern in Vital Signs by Any On-therapy Visit|Vital signs measured included systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate. Criteria for values of potential concern were determined by the medical monitors. For SBP, a decrease or increase >30 millimeters of mercury (mmHg) from Baseline was considered to be of clinical concern. For DBP, a decrease or increase >20 mmHg from Baseline was considered to be of clinical concern. For heart rate, a decrease or increase >30 beats per minute (bpm) was considered to be of clinical concern.|Week 1 through Week 25|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2685651|NCT01357889|Secondary|Number of Participants With a Change From Baseline of Clinical Concern in Hematology Values by Any On-therapy Visit|Criteria for values of potential concern were determined by the medical monitors. For hematocrit, a >0.1 decrease from Baseline was considered to be of clinical concern. For hemoglobin, a >25 grams per liter (g/L) decrease from Baseline was considered to be of clinical concern.|Week 1 through Week 25|Safety Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2685652|NCT01357889|Secondary|Number of Participants With Indicated Adverse Events of Special Interest|Adverse events of special interest included cardiovascular events, hypoglycemic events, pancreatitis events, thyroid events, gastrointestinal (GI) events, diabetic retinopathy events, systemic allergic reactions (SAR), injection site reactions (ISR), and liver events (AEs from investigations and hepatobiliary disorders were considered).|From the time the participant consented to participate in the study through Visit 28 (Week 25) or the final follow-up visit, for participants who discontinue active participation in the study|Safety Population|||Participants|||Number
2685770|NCT01356498|Secondary|Gout Flare Incidence|Percentage of participants remaining in the study during the specified interval who experienced a gout flare during this interval.|Assessed in 3-month intervals up to 2 years|The flare incidence is reported as the percentage of participants reporting flares during each 3-month interval.|||Percentage of participants|||Number
2685653|NCT01357889|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs. Hypoglycemic events are excluded from this table, except for serious adverse events.|From the time the participant consented to participate in the study through Visit 28 (Week 25) or the final follow-up visit, for participants who discontinued active participation in the study|Safety Population|||Participants|||Number
2685654|NCT01357889|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 17|This analysis used the LOCF method for missing post-Baseline FPG values. FPG values obtained after hyperglycemic rescue were treated as missing and replaced with pre-rescue values. Baseline is defined as the last available assessment on or prior to the day on which the first dose of study drug was received. Based on ANCOVA: Change = treatment + Baseline FPG + age category + weight category + background antidiabetic therapy category.|Baseline and Week 17|Efficacy Population - LOCF|||millimoles per liter||Standard Error|Least Squares Mean
2685655|NCT01357889|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 17|HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. This analysis used the last observation carried forward (LOCF) method for missing post-Baseline HbA1c values. HbA1c values obtained after hyperglycemic rescue were treated as missing and replaced with pre-rescue values. Baseline is defined as the last available assessment on or prior to the day on which the first dose of study drug was received. Based on analysis of covariance (ANCOVA): Change = treatment + Baseline HbA1c + age category + weight category + background antidiabetic therapy category.|Baseline and Week 17|Efficacy Population - LOCF: all participants who received a dose of study medication and who had a Baseline measurement and at least 1 post-Baseline HbA1c or fasting plasma glucose (FPG) measurement. Only participants available at the specified time point were analyzed.|||Percentage of HbA1c in blood||Standard Error|Least Squares Mean
2685656|NCT01357889|Secondary|Apparent Volume of Distribution in the Terminal Phase of Albiglutide in BE Phase|The apparent volume of distribution in the terminal phase (V/F) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.|||Liters||Geometric Coefficient of Variation|Geometric Mean
2685657|NCT01357889|Secondary|Apparent Clearance of Albiglutide in the BE Phase|The apparent clearance (CL/F) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.|||Liters per hour||Geometric Coefficient of Variation|Geometric Mean
2685658|NCT01357889|Secondary|t1/2 of Albiglutide in the BE Phase|The terminal elimination half-life (t1/2) of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis.|||Hours||Geometric Coefficient of Variation|Geometric Mean
2685659|NCT01357889|Secondary|Cmax of Albiglutide in the BE Phase|Cmax of albiglutide in the BE Phase was measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2685660|NCT01357889|Secondary|Tmax and Tlag of Albiglutide in the BE Phase|Time of the maximum observed plasma concentration (tmax) and the observed time prior to the first quantifiable plasma concentration (tlag) of albiglutide in the BE Phase were measured. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or terminal elimination rate constant not estimable were excluded.|||Hours||Full Range|Median
2685661|NCT01357889|Secondary|AUC (0-last) and AUC (0-inf) of Albiglutide in the BE Phase|The area under the concentration-time (AUC) curve from time zero to the last quantifiable concentration (0-last) and AUC (0-inf) of albiglutide in the BE Phase were measured. AUC is a measure of how much albiglutide is in the blood at certain time points. Blood samples for PK analysis were collected prior to dosing at Baseline and 24 hr, 48 hr, 96 hr, 120 hr, 216 hr, 312 hr, 480 hr, and 672 hr after administration of the Baseline study medication.|Pre-dose at Baseline; 24 hr, 48 hr, 96 hr, 216 hr, 312 hr, 480 hr, and 672 hr post-dose|Albiglutide PK Population. Participants with insufficient concentration data or an unestimable terminal elimination rate constant were excluded from analysis. Different par. may have been analyzed at different time points; the overall number of par. analyzed reflects everyone in the PK Population.|||nanograms*hour/milliliter||Geometric Coefficient of Variation|Geometric Mean
2685671|NCT01357850|Secondary|Change From Baseline in Cardiac and Liver Fat by Proton Spectroscopy (1H MRS)|Change in Baseline in cardiac and liver fat by proton spectroscopy was planned at Baseline and Week 13. The protocol allowed for sites to perform all or only efficacy assessments, depending on site designation, capability and feasibility. No sites that enrolled participants into this study were able to perform this outcome measure.|Baseline and Week 13|||||||
2703727|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|8 weeks|||||||
2685662|NCT01357889|Secondary|Number of Participants With Anti-albiglutide Antibody Formation at Baseline and Weeks 5, 9, 13, 17, and 25 in the Multiple-dose Phase|The presence of anti-albiglutide antibodies after repeat-dose administration was assessed using a qualified enzyme-linked immunosorbent assay. The assay involved screening, confirmation, and titration steps (tiered-testing approach). The number of participants who tested positive for anti-albiglutide antibodies are presented by visit.|Baseline, Week 5, Week 9, Week 13, Week 17, and Week 25 (Follow-up)|Safety Population: all par. who received at least 1 dose of study medication. Only those par. available at the specified time points were analyzed (represented by n= X, X in the category titles). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Safety Population.|||Participants|||Number
2685663|NCT01357889|Secondary|Trough (Pre-dose) Plasma Concentrations of Albiglutide in the Mutiple-dose Phase (MDP)|The trough concentration of albiglutide at Week 5, Week 9, Week 13, Week 17 (EOT), and Week 25 (Follow-up) following multiple-dose administration was estimated. The time and date of sample collection pre-dose was to be recorded.|Immediately pre-dose at Week 5, Week 9, Week 13, Week 17 (End of Treatment [EOT]), and Week 25 (Follow-up)|PK Concentration Population (PKCP): participants (par.) in the MDP for whom a PK sample was collected/analyzed. Only par. available at the specified time points were analyzed (n= X, X in the category titles). Different par. may have been analyzed at different time points; the overall number of par. analyzed reflects everyone in the PKCP.|||ng/mL||Standard Deviation|Mean
2685664|NCT01357850|Secondary|Number of Participants With Adverse Events by the Indicated Severity|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Severity categories: Mild: an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities;Moderate: an event that was sufficiently discomforting to interfere with normal everyday activities; Severe: an event that prevents normal everyday activities.|Baseline and Week 13|All Subjects Population. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2685665|NCT01357850|Secondary|Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Please refer to the AE/SAE section for further details.|Baseline and Week 13|All Subject Population: all randomized participants who received >= 1 dose of study medication. Only those participants available at the specified time points were analyzed.|||Participants|||Number
2685666|NCT01357850|Secondary|Change From Baseline in Quality of Life as Assessed by the Minnesota Living With Heart Failure Questionnaire|Minnesota living with heart failure questionnaire (MLHFQ) is a validated instrument to measure participant-reported quality of life at Baseline and Week 13. For each of 21 items, participants rated the effects of heart failure and its treatment on physical, socioeconomic and psychological aspects of their life. To measure the effects of symptoms, functional limitations, psychological distress on an individual's quality of life, the MLHF questionnaire asks each participant to indicate their response using a 6-point scale (ranging from 0 to 5, 0=no, 1=very little, and 5=very much). The min and max scores can range from 0 to 105. The likert scale measures the effect of heart failure and treatments for heart failure on an individual's ability to live as they want. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.|||Scores on a scale||95% Confidence Interval|Geometric Mean
2685667|NCT01357850|Secondary|Change From Baseline in Plasma Levels of Insulin|Blood samples for biomarker analysis of fasting levels of insulin were collected at Weeks 1, 7 and 13. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.|||picomole per liter (pmol/L)||Standard Error|Geometric Mean
2685668|NCT01357850|Secondary|Change From Baseline in Plasma Levels of Glucose, and Free Fatty Acids (FFA)|Blood samples for biomarker analysis of fasting levels of glucose and FFA were collected at Weeks 1, 7 and 13; glucose was also collected at Weeks 2, 4, 6, 8, 10, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed for different parameters at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.|||Millimole per liter (mmol/L)||Standard Error|Geometric Mean
2685669|NCT01357850|Secondary|Change From Baseline in Serum N-terminal Fragment Brain Natriuretic Peptide (NT-BNP) Level|Baseline is defined as the last available assessment on or prior to the first dose of study medication. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Change from Baseline at Week 13|ITT Population. Only those participants available at the specified time points were analyzed.|||Nanogram per liter||Standard Error|Geometric Mean
2685670|NCT01357850|Secondary|Change From Baseline in Exercise Capacity Assessed by 6-minute Walk Test|The six minute walk test was performed at Baseline and Week 13. All participantss were given standardized instructions and the distance walked was measured. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.|||Meters||95% Confidence Interval|Geometric Mean
2689141|NCT01328756|Primary|Change From Baseline in Pulse Rate at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||beats per minute||Standard Deviation|Mean
2685672|NCT01357850|Secondary|Change From Baseline in Cardiac Energetics (PCr/ATP) Measured by 31P Magnetic Resonance Spectroscopy (MRS)|Participants underwent a CMR scan performed on a 3 Tesla MR system at Baseline and Week 13 to assess cardiac mass, volumes (global function and dilatation), strain and torsion, cardiac and liver lipid content and cardiac energy metabolism. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|Magnetic Resonance Substudy Population (MRS): all randomized participants who participated in the MRS substudy and had valid Baseline and/or Week 13 assessments for either PCr/ATP via 31P MRS. Only those participants available at the specified time points were analyzed.|||ratio||95% Confidence Interval|Least Squares Mean
2685673|NCT01357850|Secondary|Change From Baseline in LV and RV Function Assessed by CMR (LV Mass), Myocardial Strain Assessed by Myocardial Tagging Indices|Non-contrast CMR to assess left/right ventricular ejection fraction, volume, mass, and strain was performed following a period of rest after exercise testing at Baseline and after the Week 13 treatment phase. A 3Tesla magnetic resonance imagine (MRI) examination was performed including sequences for evaluation of LV structure and function. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|CMR Substudy Population. Only those participants available at the specified time points were analyzed.|||Grams||Standard Error|Geometric Mean
2685674|NCT01357850|Secondary|Change From Baseline in LV and RV Function Assessed by CMR (LV and RV Volumes in Systole and Diastole), Myocardial Strain Assessed by Myocardial Tagging Indices|Non-contrast CMR to assess LV and RV ejection fraction, volume, mass, and strain was performed following a period of rest after exercise testing at Baseline and after the Week 13 treatment phase. A 3Tesla magnetic resonance imagine (MRI) examination was performed including sequences for evaluation of LV structure and function. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|CMR Substudy Population. Only those participants available at the specified time points were analyzed.|||Milliliters||Standard Error|Geometric Mean
2685675|NCT01357850|Secondary|Change From Baseline in LV and RV Function Assessed by Cardiac Magnetic Resonance (CMR) (LVEF), Myocardial Strain Assessed by Myocardial Tagging Indices|Non-contrast CMR to assess left ventricular (LV) and right ventricular (RV) ejection fraction, volume, mass, and strain was performed following a period of rest after exercise testing at Baseline and after the Week 13 treatment phase. A 3Tesla magnetic resonance imagine (MRI) examination was performed including sequences for evaluation of LV structure and function. Only those participants available at the specified time points were analyzed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|CMR Substudy Population: all randomized participants who participated in the CMR substudy and had valid Baseline and/or Week 13 assessments for >= 1 one of the imaging parameters of LV and RV function assessed by CMR (LVEF, LV and RV volumes in systole and diastole, LV mass), myocardial strain assessed by myocardial tagging indices.|||Percentage||Standard Error|Geometric Mean
2685676|NCT01357850|Secondary|Change From Baseline in Left Ventricular (LV) Volumes in Systole and Diastole as Assessed by Echocardiogram|Echocardiography was performed at Baseline and Week 13 using pulse-wave, continuous-wave and tissue Doppler. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.|||Milliliters||Standard Error|Geometric Mean
2685677|NCT01357850|Secondary|Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Assessed by Echocardiogram|Echocardiography was performed at Baseline and Week 13 using pulse-wave, continuous-wave, and tissue Doppler. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.|||Percentage||Standard Error|Geometric Mean
2685678|NCT01357850|Primary|Change From Baseline in Peak Oxygen Uptake (Peak VO2) as Assessed by Bicycle Cardiopulmonary Exercise Testing|Peak VO2 was measured at Baseline and Week 13. Participants performed a maximal exercise test limited by dyspnea or fatigue on a cycle ergometer. After a rest period, the workloads were increased in a step fashion by 25 watts every 3 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects ANOVA model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.|||Milliliters per kilogram per minute||95% Confidence Interval|Least Squares Mean
2685679|NCT01357850|Primary|Change From Baseline in Myocardial Efficiency (Work Performed/Myocardial Oxygen Consumption [MVO2]) Assessed at Rest|MVO2 was estimated by measuring the rate of myocardial clearance of 11C-activity which represents overall myocardial oxidative flux through the TCA cycle. Cardiac work was measured by echocardiography and cardiac efficiency index was calculated as work (by echocardiography) divided by MVO2. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects ANOVA model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects.|Baseline and Week 13|ITT Population. Only those participants available at the specified time points were analyzed.|||millimeters of mercury/liter/minute2||95% Confidence Interval|Least Squares Mean
2685680|NCT01357850|Primary|Change From Baseline in Myocardial Glucose Utilization as Assessed by [18F]Fluoro-2-deoxy-glucose Positron Emission Tomography (FDG-PET) Imaging|FDG-PET imaging was performed at Baseline and Week 13 to assess myocardial glucose uptake. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects analysis of variance (ANOVA) model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects.|Baseline and Week 13|Intent-to-Treat (ITT) Population: all randomized participants who received >= 1 dose of study medication and had >= 1 on treatment assessment. Only those participants available at the specified time points were analyzed.|||micromoles per gram per minute||95% Confidence Interval|Least Squares Mean
2685681|NCT01357720|Primary|Seroprotection Rate: Anti-B. Pertussis Antibodies|Percentage of subjects with an anti-B. pertussis antibody titer ≥20 EU/mL or a 4-fold increase over baseline (i.e. seroconversion rate)|1 month after the third vaccination|Available observations at Visit 4|||percentage of subjects||95% Confidence Interval|Number
2685682|NCT01357720|Primary|Seroprotection Rate: Anti-tetanus Toxoid Antibodies|Percentage of subjects with antibody levels against tetanus toxoid ≥0.1 IU/mL (i.e. seroprotection rate)|1 month after the third vaccination|Available observations at Visit 4|||percentage of subjects||95% Confidence Interval|Number
2685686|NCT01357655|Secondary|Number of Participants Experiencing Serious Adverse Events (SAE), Drug-Related Adverse Event (AE), AE Leading to Discontinuation, and Death|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug.|From date of first dose of study treatment up to the date of the last dose plus 30 days (approximately 49 months)|All Treated Participants; Participants enrolled in this trial could not be randomized to the Dasatinib + SMO antagonist arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).|||participants|||Number
2685687|NCT01357655|Secondary|Transformation-free Survival Measured by the Time From Start of Treatment to Criteria for Accelerated or Blast Phase CML Are Met and Death||Baseline to End of study (approximately 48 months)|The study was terminated prior to data collection for this endpoint.||||||
2685688|NCT01357655|Secondary|Event-free Survival, Measured by the Time From Start of Treatment to Progression, Death or Treatment Discontinuation||Baseline to End of study (approximately 48 months)|The study was terminated prior to data collection for this endpoint.||||||
2685689|NCT01357655|Secondary|Progression-free Survival, Measured by the Time From Start of Treatment to Progression or Death||Baseline to End of study (approximately 48 months)|The study was terminated prior to data collection for this endpoint.||||||
2685690|NCT01357655|Secondary|Complete Molecular Response at Any Time||Baseline to End of study (approximately 48 months)|The study was terminated prior to data collection for this endpoint.||||||
2685691|NCT01357655|Primary|Number of Participants With Major Molecular Response|Major molecular response (MMR) was assessed using BCR-ABL transcript levels measured by real-time quantitative polymerase chain reaction (qPCR). MMR was defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value). Number of participants with MMR by timepoint are cumulative.|Baseline up to 12 months|Efficacy Sample: all treated participants with at least one assessment on treatment. Participants enrolled in this trial could not be randomized to the Dasatinib + SMO antagonist arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).|||Participants|||Count of Participants
2685692|NCT01357616|Secondary|Mean IOP Change From Baseline (5 PM) at Week 8|Mean IOP change from baseline (5 PM) at Week 8 was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement.|Baseline, Week 8|This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit.|||mmHg||Standard Deviation|Least Squares Mean
2685693|NCT01357616|Secondary|Mean IOP Change From Baseline at 11 AM|Mean IOP change from baseline at 11 AM was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement.|Baseline, Up to Week 8|This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit.|||mmHg||Standard Deviation|Least Squares Mean
2685694|NCT01357616|Secondary|Mean IOP Change From Baseline at 9 AM|Mean IOP change from baseline at 9 AM was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement.|Baseline, Up to Week 8|This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit.|||mmHg||Standard Deviation|Least Squares Mean
2685695|NCT01357616|Primary|Mean Diurnal IOP Change From Baseline at Week 8|Mean diurnal IOP change from baseline at Week 8 (ie, the subject IOP change from baseline averaged over the 9 AM, 11AM and 5 PM time points at Week 8) was measured by Goldmann applanation tonometry. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP (fluid pressure inside the eye) can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater improvement..|Baseline, Week 8|This reporting group includes all subjects who received study medication, satisfied pre-randomization inclusion/exclusion criteria and completed at least 1 scheduled on-therapy study visit.|||millimeters mercury (mmHg)||Standard Deviation|Least Squares Mean
2685696|NCT01357577|Secondary|Patient Health Questionnaire-9 (PHQ-9)|Patient Health Questionnaire-9 (PHQ-9): The PHQ-9 is adapted from the PRIME-MD. It can be used as a screen for depression or as a severity measure. The investigators used it as a measure of severity. The PHQ-9 score is on a range of 0 to 27, where a higher score indicates higher severity.|Baseline, Post-Treatment (approximately 4-months post treatment completion), 6 months||||score on a scale||Standard Deviation|Mean
2685697|NCT01357577|Secondary|PTSD Checklist (PCL)|"A secondary measure of PTSD will be the PCL. The PCL is a widely used self-report measure that assesses the 17 DSM-IV PTSD symptoms. Responses to these questions are on a scale of 1 to 5 (not at all to extremely). A total symptom severity score (range from 17-85) can be calculated, with a higher score indicating higher symptom severity."|Baseline, Post-Treatment (approximately 4-months post treatment completion), 6-months||||score on scale||Standard Deviation|Mean
2685698|NCT01357577|Secondary|Addiction Severity Index (Drug Use)|The ASI is a standardized, structured interview that assesses past 30 days problem severity in seven areas. These seven areas include medical, employment, drug, alcohol, legal, family/social and psychiatric status. Problem severity is rated on a scale of 0.0 - 1.0 with a higher score indicative of more problem severity. All scales have a range from 0 to 1.0.|Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months||||score on scale||Standard Deviation|Mean
2685699|NCT01357577|Secondary|Addiction Severity Index (Alcohol Addiction)|The ASI is a standardized, structured interview that assesses past 30 days problem severity in seven areas. These seven areas include medical, employment, drug, alcohol, legal, family/social and psychiatric status. Problem severity is rated on a scale of 0.0 - 1.0 with a higher score indicative of more problem severity. All scales have a range from 0 to 1.0.|Baseline, Post-Treatment (approximately 4-months after treatment conclusion), and 6-Months||||score on scale||Standard Deviation|Mean
2685700|NCT01357577|Primary|CAPS Total Score Analysis Among Participants Completing at Least One Follow-up Assessment.|PTSD symptom severity will be measured by the Clinician Administered PTSD Scale (CAPS). The Clinician Administered PTSD SCALE (CAPS) is the gold standard in PTSD assessment. It is a structured interview that can be used to: Make current (past month) diagnosis of PTSD and Make lifetime diagnosis of PTSD. The minimum value is a 0 and the maximum is 135, the higher the score the worse the outcome, i.e. the more severe PTSD.|Conclusion of treatment (post-treatment occurs approximately 4-months after treatment conclusion) and 6 months follow-up|Our intention-to-treat analysis has N=80 patients (33 CBT; 47 control): It consists of patients with at least one follow-up (post or 6-mo) assessment (e.g., of the 64 participants randomized to CBT, 24 and 27 had a CAPS assessment at post and 6 months, respectively, with 33 participants having at least one valid follow-up CAPS).|||score on scale||Standard Deviation|Mean
2685701|NCT01357564|Secondary|12-item Zarit Burden Short Form Measuring Caregiver Burden|"Caregiver burden as measured by the 12-item Zarit Burden Short Form.~Scores range from 0-48, with higher scores indicating burden; scores over 17 indicate particularly high levels of caregiver burden.~The change between 2 or more time points is being reported. Baseline to T2 (4 months) - short-term measure; and baseline to T3 (8 months) - long term measure"|Baseline, 4 month (short-term follow-up), 8 month (long-term)||||units on a scale|||Number
2685702|NCT01357564|Primary|The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia.|"The Neuropsychiatric Inventory (NPI) assesses the frequency and severity of 12 common behavioral symptoms in dementia.~The NPI Score is calculated by multiplying the total reported frequency by the severity score, with a theoretical range of 0-1704: high scores indicating greater frequency by severity.~The change between 2 or more time points is being reported. Baseline to T2 (4 months) - short-term measure; and baseline to T3 (8 months) - long term measure"|Baseline, 4 month (short-term follow-up), 8 month (long-term)||||score on a scale||95% Confidence Interval|Mean
2685703|NCT01357551|Secondary|Estimated Metabolic Minutes of Moderate Physical Activity Per Week|self-reported based on short form of International Physical Activity Questionnaire|56 weeks||||metabolic minutes per week||Standard Deviation|Mean
2685704|NCT01357551|Secondary|Estimated Metabolic Minutes of Walking Per Week|self-reported based on short form of International Physical Activity Questionnaire|56 weeks||||metabolic minutes per week||Standard Deviation|Mean
2685705|NCT01357551|Secondary|Estimated Daily Caloric Intake|Based on self-report using Block Brief Food Frequency Questionnaire|56 weeks||||kcal per day||Standard Deviation|Mean
2685706|NCT01357551|Primary|Weight||56 weeks post-randomization||||kilograms||Standard Deviation|Mean
2685707|NCT01357512|Secondary|Proportion of Clinically Significant Prostate Cancers Detected in MRI and no MRI Groups|Number of clinically significant prostate cancers detected with and without MRI. Clinically significant prostate cancer is determined by the Gleason grading and be the number of cancer-positive biopsy cores.|at the end of the study (up to 1 year)|||||||
2685708|NCT01357512|Secondary|Number of Positive Biopsies in MRI and no MRI Groups|The number of biopsies with histology confirming prostate cancer are compared between MRI and no MRI groups. This measure will clarify if prostate cancer can be diagnosed more accurately, i.e. more biopsies with confirmed prostate cancer, after MRI. Ten or 12 biopsies will be taken from prostates below 30 grams, or equal or above 30 grams, respectively.|at the end of the study (up to 1 year)||||number of cancer-positive biopsy cores||Inter-Quartile Range|Median
2685709|NCT01357512|Primary|Number of Prostate Cancer Diagnoses in MRI and no MRI Groups|The number of patients with confirmed prostate cancer among men with MRI performed before biopsies are compared to the number of patients with prostate cancer confirmed in prostate biopsies without MRI. The number patients with prostate cancer are counted as total from cancers detected in random biopsies and in biopsies targeted based on suspicious MRI findings in MRI group, and from random biopsies in no MRI group.|at the end of the study (up to 1 year)||||participants|||Number
2685710|NCT01357239|Secondary|Change From Baseline in Repetitive Behaviors Assessed Using the Repetitive Behavior Scale - Revised (RBS-R) Total and Subscale Scores in Stratum II|The Repetitive Behavior Scale - Revised (RBS-R) is a rating tool that captures the breadth of repetitive behavior. It is a 43-item questionnaire filled by the caregivers. Each behavior assessed is rated from 0 (behavior does not occur) to 3 (behavior occurs and it is a severe problem). The total score ranks from 0 to 129. The behaviors are grouped into six domains: ritualistic behavior (range 0 to 18); sameness behavior (range 0 to 33); stereotypic behavior (range 0 to 18); self-injurious behavior (range 0 to 24); compulsive behavior (range 0 to 24); and restricted interests (range 0 to 12). A negative change represents improvement. Stratum II included patients whose FMR1 gene was partially methylated|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Score on a scale||Standard Error|Least Squares Mean
2685711|NCT01357239|Secondary|Change From Baseline in Repetitive Behaviors Assessed Using the Repetitive Behavior Scale - Revised (RBS-R) Total and Subscale Scores in Stratum I|The Repetitive Behavior Scale - Revised (RBS-R) is a rating tool that captures the breadth of repetitive behavior. It is a 43-item questionnaire filled by the caregivers. Each behavior assessed is rated from 0 (behavior does not occur) to 3 (behavior occurs and it is a severe problem). The total score ranks from 0 to 129. The behaviors are grouped into six domains: ritualistic behavior (range 0 to 18); sameness behavior (range 0 to 33); stereotypic behavior (range 0 to 18); self-injurious behavior (range 0 to 24); compulsive behavior (range 0 to 24); and restricted interests (range 0 to 12). A negative change represents improvement. Stratum I included patients whose FMR1 gene was fully methylated|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Score on a scale||Standard Error|Least Squares Mean
2685712|NCT01357239|Secondary|Proportion of Patients With Clinical Response, Where Response is Defined as a Reduction of at Least 25% From Baseline in the ABC-CFX Total Score and a Score of 1 (Very Much Improved) or 2 (Much Improved) on the CGI-I Scale, Stratum II|"The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (not at all a problem) to 3 (problem is severe in degree) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to ABC-CFX algorithm, for which 55 items and six subscales plus the total score were considered, and for which the total score ranks from 0 to 165. The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being very much improved, 4 being no change to 7 being very much worse). Stratum I included patients whose FMR1 gene was fully methylated; Stratum II included patients whose FMR1 gene was partially methylated."|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Total is the number of patients with non-missing baseline ABC-CFX total score and at least one nonmissing post-baseline ABC-CFX total score and CGI-I assessment|||Number of participants|||Number
2685713|NCT01357239|Secondary|Proportion of Patients With Clinical Response, Where Response is Defined as a Reduction of at Least 25% From Baseline in the ABC-CFX Total Score and a Score of 1 (Very Much Improved) or 2 (Much Improved) on the CGI-I Scale, Stratum I|"The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (not at all a problem) to 3 (problem is severe in degree) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to ABC-CFX algorithm, for which 55 items and six subscales plus the total score were considered, and for which the total score ranks from 0 to 165. The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being very much improved, 4 being no change to 7 being very much worse). Stratum I included patients whose FMR1 gene was fully methylated; Stratum II included patients whose FMR1 gene was partially methylated."|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Total is the number of patients with non-missing baseline ABC-CFX total score and at least one nonmissing post-baseline ABC-CFX total score and CGI-I assessment|||Number of participants|||Number
2685714|NCT01357239|Secondary|Change From Baseline in Irritability, Lethargy/Withdrawal, Stereotypic Behavior, Hyperactivity, Inappropriate Speech, and Social Avoidance Assessed by the Individual Subscales of the ABC-CFX Scale in Stratum II|"The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (not at all a problem) to 3 (problem is severe in degree) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales: irritability (range 0 to 54); lethargy/withdrawal (range 0 to 39); stereotypic behavior (range 0 to 18); hyperactivity (range 0 to 30); inappropriate speech (range 0 to 12); and social avoidance (range 0 to 12) plus the total score (range 0 to 165) were considered. A negative change represents improvement. Stratum II included patients whose FMR1 gene was partially methylated"|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Score||Standard Error|Least Squares Mean
2685715|NCT01357239|Secondary|Change From Baseline in Irritability, Lethargy/Withdrawal, Stereotypic Behavior, Hyperactivity, Inappropriate Speech and Social Avoidance Assessed by the Individual Subscales of the ABC-CFX Scale in Stratum I|"The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (not at all a problem) to 3 (problem is severe in degree) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales: irritability (range 0 to 54); lethargy/withdrawal (range 0 to 39); stereotypic behavior (range 0 to 18); hyperactivity (range 0 to 30); inappropriate speech (range 0 to 12); and social avoidance (range 0 to 12) plus the total score (range 0 to 165) were considered. A negative change represents improvement. Stratum I included patients whose FMR1 gene was fully methylated"|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Score||Standard Error|Least Squares Mean
2685716|NCT01357239|Secondary|Global Improvement of Symptoms in Fragile X Using the Clinical Global Impression-Improvement (CGI-I) Scale in Stratum II|"The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being very much improved, 4 being no change to 7 being very much worse). Stratum II included patients whose FMR1 gene was partially methylated"|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Participants|||Number
2685746|NCT01356628|Secondary|Overall Survival (OS)|Overall survival (OS) is measured from the entry onto the trial until death of any cause. Date and cause of death will be recorded. The cause of death will be categorized as either cancer-related or cancer-unrelated.|Every 2 weeks during first 3 cycles, then monthly during treatment. Then Day 28, Day 56 and every 3 months from last administration of protocol directed therapy or death||2019-12-31|12/2019||||
2689647|NCT01325181|Secondary|Number of Participants Who Underwent Rescue Treatment|number of participants who underwent rescue treatment: ranibizumab injections for the low-fluence PDT group and low-fluence PDT for the ranibizumab group|12 months|||||||
2685717|NCT01357239|Secondary|Global Improvement of Symptoms in Fragile X Using the Clinical Global Impression-Improvement (CGI-I) Scale in Stratum I|"The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being very much improved, 4 being no change to 7 being very much worse). Stratum I included patients whose FMR1 gene was fully methylated."|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Participants|||Number
2685718|NCT01357239|Secondary|Global Improvement of Symptoms in Fragile X Using the Clinical Global Impression- Improvement (CGI-I) Scale in Stratum II Patients|"The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being very much improved, 4 being no change to 7 being very much worse). Stratum II included patients whose FMR1 gene was partially methylated"|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Score||Standard Error|Least Squares Mean
2685719|NCT01357239|Secondary|Global Improvement of Symptoms in Fragile X Using the Clinical Global Impression- Improvement (CGI-I) Scale in Stratum I Patients|"The Clinical Global Impression-Improvement (CGI-I) scale is a clinician rated scale used to assess treatment response in psychiatric patients, and the score ranges from 1 to 7 (with 1 being very much improved, 4 being no change to 7 being very much worse). Stratum I included patients whose FMR1 gene was fully methylated."|12 weeks|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Score||Standard Error|Least Squares Mean
2685720|NCT01357239|Secondary|Change From Baseline in Behavioral Symptoms of Fragile X Syndrome Using the ABC-CFX Total Score in Stratum I Patients Exposed to the Two Lower Doses of AFQ056 (25 mg Bid and 50 mg Bid)|"The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (not at all a problem) to 3 (problem is severe in degree) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales (irritability, lethargy/withdrawal, stereotypic behavior, hyperactivity, inappropriate speech and social avoidance) plus the total score were considered, and for which the total score ranks from 0 to 165. Stratum I included patients whose FMR1 gene was fully methylated"|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Score||Standard Error|Least Squares Mean
2685721|NCT01357239|Secondary|Change From Baseline in Behavioral Symptoms of Fragile X Syndrome Using the ABC-CFX Total Score in Stratum II Patients Exposed to All 3 Doses of AFQ056|"The ABC-C is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (not at all a problem) to 3 (problem is severe in degree) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales (irritability, lethargy/withdrawal, stereotypic behavior, hyperactivity, inappropriate speech and social avoidance) plus the total score were considered, and for which the total score ranks from 0 to 165. Stratum II included patients whose FMR1 gene was partially methylated"|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Score||Standard Error|Least Squares Mean
2685722|NCT01357239|Primary|Change From Baseline in Behavioral Symptoms of Fragile X Syndrome Using the Aberrant Behavior Checklist-Community Edition (ABC-CFX) Total Score in Stratum I Patients Exposed to AFQ056 100 mg Bid|"The Aberrant Behavior Checklist-Community edition (ABC-C) is a 58-item, caregiver-rated symptom checklist for assessing problem behaviors of children and adults with mental retardation at home, in residential facilities, and work training centers. The assessment was done by attributing to each item a score from 0 (not at all a problem) to 3 (problem is severe in degree) and the total score ranks from 0 to 174. The data collected from the full, 58-item ABC-C were analyzed according to the modified FXS ABC-C algorithm (ABC-CFX) for which 55 items and six subscales (irritability, lethargy/withdrawal, stereotypic behavior, hyperactivity, inappropriate speech and social avoidance) plus the total score were considered, and for which the total score ranks from 0 to 165. Stratum I included patients whose Fragile X Mental Retardation 1 (FMR1) gene was fully methylated"|Baseline to week 12|Full Analysis Set (FAS):all randomized patients who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline assessment for the primary efficacy parameter. Only participants who had a value at the given time and the assessment was within the window for analysis were included|||Score||Standard Error|Least Squares Mean
2685723|NCT01357161|Secondary|Part 2: Median Overall Survival (OS) in Months|OS was defined as the time from randomization to death due to any cause, reported in months. Participants without documented death at the time of analysis were censored at the date last known to be alive. For this endpoint, all randomized participants in Part 2 were analyzed. Per protocol, Part 1 participants were not evaluated for OS.|Up to 57 months|ITT Population: All randomized participants in Part 2|||months||95% Confidence Interval|Median
2685767|NCT01356589|Secondary|Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling|Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks.|9 months|Analysis population included all treated participants. 'N' (number of participants analyzed) included those participants who were evaluable for this outcome measure.|||percentage of participants|||Number
2685724|NCT01357161|Secondary|Part 2: ORR Per GCIG Criteria Based on Both Enhanced RECIST 1.1 and CA125 Level by Independent Radiology Review|ORR defined as the percentage of participants with best response of confirmed PR or CR based both on imaging per enhanced RECIST 1.1 and on serum marker CA-125 level according to GCIC criteria. CR defined by enhanced RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have had reduction in short axis to <10 mm. PR was defined by enhanced RECIST 1.1 as ≥30% decrease in SOV of target lesions, taking as reference baseline SOV. Response according to CA-125 had occurred if there was ≥50% reduction in CA-125 levels from pretreatment sample. Response must have been confirmed and maintained for ≥28 days. Participants could be evaluated according to CA-125 only if they had a pretreatment sample that was ≥2 times the upper limit of normal and within 2 weeks prior to starting treatment. All randomized participants in Part 2 were analyzed. Per protocol, Part 1 participants were not included in this analysis.|Up to 57 months|ITT Population: All randomized participants in Part 2|||percentage of participants||95% Confidence Interval|Number
2685725|NCT01357161|Primary|Parts 1 and 2: Percentage of Participants That Discontinued Study Treatment Due to an AE|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The percentage of participants that discontinued study treatment (paclitaxel, carboplatin, or MK-1775) due to an AE was reported for each treatment arm.|Part 1: Day 1 through Post Study (286 days total). Part 2: Day 1 through Post Study (479 days total)|"Part 1: All participants who received at least one dose of study treatment during the open-label period.~Part 2: All randomized participants who received at least one dose of study treatment. 2 participants were randomized to the Part 2 placebo arm but were not treated."|||percentage of participants|||Number
2685726|NCT01357161|Primary|Parts 1 and 2: Percentage of Participants That Experienced an Adverse Event (AE)|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The percentage of participants that experienced at least one AE was reported for each treatment arm.|Part 1: Day 1 through Post Study (286 days total). Part 2: Day 1 through Post Study (479 days total)|"Part 1: All participants who received at least one dose of study treatment during the open-label period.~Part 2: All randomized participants who received at least one dose of study treatment. 2 participants were randomized to the Part 2 placebo arm but were not treated."|||percentage of participants|||Number
2685727|NCT01357161|Primary|Part 1: Number of Participants With a Dose Limiting Toxicity (DLT)|DLTs assessed during first 21-day cycle of Part 1 and defined as toxicities that met pre-defined severity criteria, were possibly, probably, or definitely related to triplet therapy, and could possibly result in a change in the given dose. Hematologic DLTs included Grade (Gr) 3 or Gr 4 neutropenia with fever >38.5°C and/or infection requiring antibiotic or anti-fungal treatment, and any Gr 4-5 hematological toxicity EXCEPT Gr 4 anemia, leukopenia, lymphopenia, neutropenia lasting <7 days, and thrombocytopenia lasting <4 days, except if a platelet transfusion was required. Non-hematologic DLT defined as any Gr 3, 4, or 5 nonhematologic toxicity EXCEPT: Gr 3 nausea, vomiting, diarrhea, or dehydration judged by Investigator and SPONSOR to occur in setting of inadequate compliance with supportive care measures and last for less than 48 hours, alopecia of any grade, inadequately treated hypersensitivity reactions, or clinically non-significant, treatable or reversible lab abnormalities.|During Cycle 1 of Part 1 (first 21 days)|All participants who received ≥1 dose of study treatment during Cycle 1 of Part 1 open-label period and were evaluable at the time of the interim analysis. One participant took a prohibited medication during Part 1 and was considered unevaluable. Two participants enrolled into Part 1 after the interim analysis database lock and were not included.|||participants|||Number
2685728|NCT01357161|Secondary|Part 2: Median PFS in Weeks Based on RECIST 1.1 by Independent Radiology Review|PFS was defined as the time from randomization to progressive disease (based on blinded independent central radiologic review) or death, whichever occurred earlier. Tumor response was evaluated every 6 weeks during treatment by diagnostic anatomic imaging and objective response assessments were performed based on RECIST 1.1 criteria. According to RECIST 1.1, progressive disease was the appearance of one or more new lesions, OR a ≥20% increase in the sum of target lesion diameters (SOD) taking as reference the nadir (smallest SOD recorded since treatment started). PFS was analyzed for all randomized participants in Part 2 using the Kaplan-Meier method and median PFS was reported in weeks. Per protocol, Part 1 participants were not included in this analysis.|Up to 57 months|ITT Population: All randomized participants in Part 2|||weeks||95% Confidence Interval|Median
2685729|NCT01357161|Secondary|Part 1: Objective Response Rate (ORR) Per Gynecological Cancer Intergroup (GCIG) Criteria Based on Both RECIST 1.1 and Cancer Antigen 125 (CA-125) Level by Independent Radiology Review|ORR was defined as the percentage of participants whose best response was confirmed partial response (PR) or complete response (CR) based both on imaging per RECIST 1.1 and on serum marker CA-125 level according to GCIC criteria. CR was defined by RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 mm. PR was defined by RECIST 1.1 as at least a 30% decrease in the sum of the diameters (SOD) of target lesions, taking as reference the baseline SOD. A response according to CA-125 had occurred if there was ≥50% reduction in CA-125 levels from a pretreatment sample. The response must have been confirmed and maintained for at least 28 days. Participants could be evaluated according to CA-125 only if they had a pretreatment sample that was ≥2 times the upper limit of normal and within 2 weeks prior to starting treatment. Only evaluable Part 1 participants were included in this analysis.|Up to 57 months|All participants receiving MK-1775 (225 mg) during Part 1 and evaluable at the time of the interim analysis. One participant took a prohibited medication during Part 1 and was considered unevaluable. Two participants enrolled into Part 1 after the interim analysis database lock and were not included.|||percentage of participants||95% Confidence Interval|Number
2685768|NCT01356589|Secondary|Number of Full Hemoglobin Cycles Per Participant|Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks.|9 months|Analysis population included all treated participants.|||cycles||Standard Deviation|Mean
2685730|NCT01357161|Primary|Part 2: Median Progression-free Survival (PFS) in Weeks Based on Enhanced Response Evaluation Criteria In Solid Tumors Version 1.1 (Enhanced RECIST 1.1) by Independent Radiology Review|PFS was defined as the time from randomization to progressive disease (based on blinded independent central radiologic review) or death, whichever occurred earlier. Tumor response was evaluated every 6 weeks during treatment by diagnostic anatomic imaging and objective response assessments were performed based on enhanced RECIST 1.1 criteria. According to enhanced RECIST 1.1, progressive disease was the appearance of one or more new lesions, OR an unambiguous increase in the sum of target lesion volumes with both 1) >20% increase in the sum of volumes (SOV) of all target lesions (taking as reference the nadir) and 2) greater than two times the variability of the measurements estimated by the sponsor and/or its designees. PFS was analyzed for Part 2 participants only using the Kaplan-Meier method and median PFS was reported in weeks. Per protocol, Part 1 participants were not included in this analysis.|Up to 57 months|Intent to Treat (ITT) Population: All randomized participants in Part 2|||weeks||95% Confidence Interval|Median
2685731|NCT01357148|Primary|Number of Participants Taking Concomitant Medications||Up to approximately 28 months||||participants|||Number
2685732|NCT01357148|Primary|Number of Participants With Concomitant Conditions||Up to approximately 28 months||||participants|||Number
2685733|NCT01357148|Primary|Age of Participants Prescribed Sitagliptin Phosphate/Metformin HCl||Up to approximately 28 months||||years||Standard Deviation|Mean
2685734|NCT01357148|Primary|Number of Participants With an Adverse Event||Up to approximately 28 months||||participants|||Number
2685735|NCT01357135|Primary|Percentage of Participants With Strict Changes in Initial Dual Therapy|Strict changes in dual therapy were defined as withdrawal of an agent, replacement of one agent by another, or the addition of a third agent. Changes in dose level were not considered strict changes.|Up to 3 years|All eligible participants receiving dual therapy metformin + sitagliptin or metformin + sulfonylurea.|||Percentage of Participants|||Number
2685736|NCT01357135|Primary|Median Duration (in Months) of Initial Dual Therapy|The treatment maintenance duration corresponds to the treatment maintenance and persistence duration for dual therapy combining the same agents. Withdrawal of an agent, replacement of one agent by another or addition of a third agent is perceived as a change in treatment and, hence, the end of the treatment maintenance duration for dual therapy.|Up to 3 years|All eligible participants receiving dual therapy with metformin + sitagliptin or metformin + sulfonylurea.|||months||95% Confidence Interval|Median
2685737|NCT01356966|Secondary|Change in Heart-rate-corrected Augmentation Index (AIx)|The augmentation index (AIx) is a measure of systemic arterial stiffness, and is defined as the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows: HR-corrected AIx = -0.39 x (75 - HR) + AIx. The mean AIx for each group was estimated as an average and expressed as a change from baseline to 12 weeks.|Baseline, 12 weeks||||percent||Standard Error|Mean
2685738|NCT01356966|Secondary|Change in Mean Central Augmentation Index (AIx)|The augmentation index (AIx) is a measure of systemic arterial stiffness, and is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. The mean AIx for each group was estimated as an average and expressed as a change from baseline to 12 weeks.|Baseline, 12 weeks||||percent||Standard Error|Mean
2685739|NCT01356966|Primary|Change in Resting Muscle Sympathetic Nerve Activity (MSNA)||Baseline, 12 weeks|Two subjects withdrawn from each arm due to adverse events. Additionally, two subjects from the treatment group and one subject from the placebo group were not included in this analysis because an adequate MSNA neurogram was unable to be obtained at the end of the study.|||bursts/minute||Standard Error|Mean
2685740|NCT01356940|Secondary|Stepcount|change in daily stepcount recorded by an accelerometer and averaged over 1 week of wear baseline vs 4 weeks|10 weeks|total subject population|||steps per day||Standard Deviation|Least Squares Mean
2685741|NCT01356940|Primary|Peak Activity Index|peak activity index is a measure of the 30 fastest minutes of walking over a 24 hour period, averaged over one week of accelerometer wear. Measurement is change from baseline to 4 weeks on intervention|10 weeks||||change in strides per minute||Standard Deviation|Mean
2685742|NCT01356667|Secondary|Mental Health and Psychosocial Characteristics as Measured by the Addiction Severity Index, Native American Version and Brief Symptom Inventory.|The Addiction Severity Index, Native American Version will be utilized to assess problem severity in alcohol use, drug use, employment, family and social relationships, legal, psychological, and medical status. In addition, additional information with regards to mental health characteristics will be obtained from the Brief Symptom Inventory.|Change from Baseline in Mental Health and psychosocial characteristics at 6 months|Please be advised that this clincial trial was terminated prior to finalization of any research procedures.||||||
2685743|NCT01356667|Secondary|Knowledge of Alcoholics Anonymous Concepts as a Measure of Protocol Comprehension|The General Alcoholics Anonymous Tools of Recovery (GAATOR 2.1) will be provided in order to determine and track patient's knowledge of the 12-steps during their participation in the DARTNA treatment program.|Change from Baseline in Knowledge of Alcoholics Anonymous at 12 weeks|Please be advised that this clincial trial was terminated prior to finalization of any research procedures.||||||
2685744|NCT01356667|Primary|Drug and Alcohol Use as a Measure of Treatment Effectiveness|Urine drug screens and breathalyzers will be obtained from patients in order to determine their recent drug and alcohol use.|Change from Baseline in Drug and Alcohol use at 6 months|Please be advised that this clincial trial was terminated prior to finalization of any research procedures.||||||
2685745|NCT01356628|Secondary|Response Rate (RR)|The best overall response is the best response recorded from the start of treatment until disease progression or recurrence. The objective response rate is the proportion of subjects with either a confirmed complete response (CR) or a confirmed partial response (PR) as determined using modified RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Subjects with the response of stable disease (SD) will be recorded and documented. Disease control rate defined as CR+PR+SD will be calculated for all subjects treated with PD-0332991.|Every 8 weeks||2019-12-31|12/2019||||
2685771|NCT01356498|Secondary|Gout Flare Frequency|The the mean number of flares per subject (flare frequency)was assessed over 3-month periods for up to 2 years of treatment|Up to 2 years|Analysis is based on ITT population, and is presented by intervals of time on pegloticase|||Flares||Standard Deviation|Mean
2685747|NCT01356628|Secondary|Number of Adverse Events|The number and nature of adverse events as a measure of safety and tolerability. Safety analysis will be conducted on all patients who receive at least one dose of PD-0332991 during the study period or follow-up. An adverse event is any unfavorable and unintended sign, symptom, syndrome or illness that develops during the period of observation in the clinical study, including a new illness or condition, worsening of a concomitant illnesses or condition, effect of the study medication or combination of 2 or more factors.|From date of randomization through study completion, assessed up to 100 months||||Adverse Events|||Number
2685748|NCT01356628|Primary|Time to Disease Progression|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST Version 1.1), as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progression.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months||||months||Full Range|Mean
2685749|NCT01356602|Secondary|C-reactive Protein Level|A central laboratory was used for analysis of all blood samples collected.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||mg / L||95% Confidence Interval|Least Squares Mean
2685750|NCT01356602|Secondary|Amount of Rescue Medication Taken (mg)|Patients used a diary to record the time of intake of rescue medication and the amount taken.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||milligrams (mg)||Standard Deviation|Mean
2685751|NCT01356602|Secondary|Time to First Rescue Medication Intake|Patients used a diary to record the time of intake of rescue medication and the amount taken.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Hours||Full Range|Median
2685752|NCT01356602|Secondary|Proportion of Patients With Rescue Medication Intake|Patients used a diary to record the time of intake of rescue medication and the amount taken.|12 weeks|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Percentage of Particpants|||Number
2685753|NCT01356602|Secondary|Physician's Assessment of Range of Motion of the Most Affected Joint|The study physician assessed the patient's range of motion of the most affected joint on a 5 point Likert scale (normal, mildly restricted, moderately restricted, severely restricted and immobilized).|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Percentage of Participants|||Number
2685754|NCT01356602|Secondary|Physician's Assessment of Erythema|The study physician assessed the most affected joint for erythema. Erythema was assessed as present, absent or not assessable.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Percentage of Participants|||Number
2685755|NCT01356602|Secondary|Physician's Assessment of Swelling|The study physician assessed the most affected joint for swelling. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Percentage of Partipants|||Number
2685756|NCT01356602|Secondary|Physician's Assessment of Tenderness|"The study physician assessed the most affected joint for tenderness. Tenderness was measured on a 0 - 3 point scale as follows: 0 = no pain, 1 = patient states that there is pain, 2 = patient states there is pain and winces and 3 = patient states there is pain, winces and withdraws on palpation or passive movement of the affected study joint."|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Percentage of Participants|||Number
2685757|NCT01356602|Secondary|Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale|A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Study physicians scored their assessment of the patients' response to treatment on a 5-point Likert scale (very good, good, fair, poor, very poor).|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Percentage of Participants|||Number
2685758|NCT01356602|Secondary|Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale|A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their response to treatment on a 5-point Likert scale (excellent, good, acceptable, slight, poor). This outcome measure shows the number of patients indicating each score on the scale.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Percentage of Participants|||Number
2685769|NCT01356589|Primary|Percentage of Participants With at Least One Hemoglobin Cycling|Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of greater than or equal to (>=) 1.5 gram per deciliter (g/dL) and a duration >=8 weeks.|9 months|Analysis population included all treated participants.|||percentage of participants|||Number
2685759|NCT01356602|Secondary|Time to Resolution of Gouty Arthritis Flare as Reported by Patient|Patients completed diary entries at 6, 12, 24, 48 and 72 hours post dose and then daily up to 7 days post-dose and/or daily until resolution of the flare. Kaplan Meier estimate of time to resolution of gouty flare as reported by patient, along with associated 95% confiedence interval, were reported.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Hours||95% Confidence Interval|Median
2685760|NCT01356602|Secondary|Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS|The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Kaplan Meier estimate of time to 50% reduction in baseline pain, along with associated 95% confidence interval, were reported.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Hours||95% Confidence Interval|Median
2685761|NCT01356602|Secondary|Time to the First New Gouty Arthritis Flare|Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely. Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.|12 weeks|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Days||95% Confidence Interval|Median
2685762|NCT01356602|Secondary|Number of Patients With at Least One New Gouty Arthritis Flare After Baseline|Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.|12 weeks|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Particpants|||Number
2685763|NCT01356602|Secondary|Patient's Assessment of Pain Intensity on a 5-point Likert Scale|A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity Likert measurements up to 14 days.|72 hours|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Percentage of Patients|||Number
2685764|NCT01356602|Secondary|Patient's Assessment of Pain Intensity on a 0-100mm VAS|The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity VAS measurements up to 14 days.|14 days|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Millimeters||Standard Error|Least Squares Mean
2685765|NCT01356602|Secondary|Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups|The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.|72 hours post dose|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Millimeters||Standard Error|Least Squares Mean
2685766|NCT01356602|Primary|Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups|The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.|72 hours post dose|Full Analysis Set: The Full Analysis Set (FAS) consisted of all patients as randomized that had at least one dose of study drug. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.|||Millimeters||Standard Error|Least Squares Mean
2685772|NCT01356498|Secondary|Patient Reported Outcome: SF-36 Physical Component Summary Score|"SF-36 is the Medical Outcomes Survey Short Form-36, a 36-item self-reported questionnaire which assesses health-related limitations in 8 dimensions. The Physical Component Summary Score (PCS) is a composite summary score derived from the dimensions related to physical functioning outcomes: Physical Function, Role Physical, General Health and Bodily Pain (each with a 0 to 100 scale where 0=worst, 100=best).~The Summary Score is constructed as a T-score with a mean of 50 and standard deviation of 10, where higher scores indicate a better health status."|RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101|Number of participants was the subset of the ITT population with SF-36 baseline data|||units on a scale||Standard Deviation|Mean
2685773|NCT01356498|Secondary|Tophus Response|Target tophi evaluated during the randomized, controlled study were followed for response at 3, 6, 12, 18 and 24 months in this open-label extention study. Results from each participant's final assessment on drug are reported (as last observation carried forward). Complete response=complete disappearance of at least one tophus with no new or worsening tophus. Partial Response=a 50% or more decrease in at least one tophus with no new or worsening tophus.|Up to 2 years|ITT, Last observation(on drug) carried forward showing patients with an Overall Tophus Response of Complete or Partial Response.|||participants|||Number
2685774|NCT01356498|Primary|Uric Acid (mg/dL)|Uric acid measured at 3 month-intervals|Week 13, Week 25, Week 53, Week 101|ITT|||mg/dL||Standard Deviation|Mean
2685775|NCT01356407|Secondary|Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation|The Proportion of subjects requiring a repeat colonoscopy due to poor bowel preparation|Day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.|||participants|||Number
2685776|NCT01356407|Secondary|Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score)|"At colonoscopy, bowel preparations were rated by the treatment-blinded endoscopist, as being of an overall quality adequate for clinical diagnostic purposes (Y/N). The total Ottawa Scale scores was correlated with 'adequate' or 'inadequate' quality of bowel preparation for clinical diagnostic purposes"|Day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
2685777|NCT01356407|Secondary|Percentage of Successful Completion of Colonoscopy|An overview of completion rates of colonoscopy (i.e., endoscope reaching the ileocecal valve)|Day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.|||Percentage of Subjects (%)|||Number
2685778|NCT01356407|Secondary|Ottawa Scale Score by Colon Segment|Mean Ottawa Scale scores, and score categories (from 'excellent' to 'bad'), are summarised by colon segment together with the overall fluid content score|Day 2|All randomized patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
2685779|NCT01356407|Secondary|Patient Response to Acceptability and Tolerability Questionnaire|On the day of the procedure, but before colonoscopy or any sedation for colonoscopy, subjects were asked to complete a standardised questionnaire regarding whether or not complete the IMP (yes or no), ease of taking IMP (rating from 1 point(very easy) to 5 point (very difficult)), degree of acceptability to study med (rating from 1 point (excellent) to 5 point (bad)), palatability of IMP (rating from 1 point (excellent) to 5 point (bad)) and tolerability (5 adverse reactions including abdominal bloating, spasms, nausea, vomiting and general malaise which were generally reported in bowel preparation with rating according to intensity from 1 point (None) to 4 point (Severe)).|Day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set|||units on a scale||Standard Deviation|Mean
2685780|NCT01356407|Primary|The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation|The total Ottawa Bowel Preparation Scale (OBPS) score, rated by the treatment-blinded Investigator at colonoscopy, was designed to evaluate cleanliness of the colon by grading the endoscopic visibility of the mucosa according to a scale from 0 ('excellent' visibility) to 4 ('inadequate' visibility); The component scores for each of the colon segment are added together, along with an overall 'fluid' score (from small amount = 0, to large amount = 2). Thus, the total OBPS has a range from 0 (a perfect preparation) to 14 (a completely unprepared bowel)|day 2|Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.|||units on a scale||Standard Deviation|Mean
2685781|NCT01356277|Secondary|Annualized Change in Estimated Glomerular Filtration Rate (eGFR)|Change in estimated glomerular filtration rate, estimated using the Schwartz equation for those < 18 y. and the CKD-EPI equation for those 18y and older, standardized to a 12-month period.|12 months|included all those with eGFR data available|||ml/min/1.73m^2||Inter-Quartile Range|Median
2685782|NCT01356277|Secondary|Acute Rejection Rate|The acute rejection rate, measured as rejections per 100 person-years of observation.|12 months|included all those who participated during the intervention interval|||events per 100 person-years|||Number
2685783|NCT01356277|Secondary|Self-reported Timing Adherence|Self-reported timing adherence, assessed using the Medical Adherence Measure- Medication Module (MAM-MM), was scored as the proportion of doses taken up to 2 hours after the prescribed time in the previous week. MAM-MM scores for each patient were summarized as the mean of the four scores post-intervention.|12 months|included all those who participated during the intervention interval|||percentage of doses taken on time||Standard Deviation|Mean
2685784|NCT01356277|Secondary|Self-reported Taking Adherence|Self-reported taking adherence, assessed using the Medical Adherence Measure- Medication Module (MAM-MM), was scored as the proportion of doses taken in the previous week. MAM-MM scores for each patient were summarized as the mean of the four scores post-intervention.|12 months|included all those who participated during the intervention interval|||percentage of prescribed doses taken||Standard Deviation|Mean
2686923|NCT01346371|Primary|Tear Osmolarity|The TearLab Osmolarity System will be used to assess tear film osmolarity, measured in mOsms/L.|56 days after initial screening visit|Analysis per protocol as ITT and LOCF for all subject eyes.|||mOsM/L|Eyes|Standard Deviation|Mean
2685785|NCT01356277|Secondary|Standard Deviation (SD) of Tacrolimus Trough Levels|The SD of all tacrolimus trough levels done for clinical care (except during hospitalizations or illnesses) were calculated for participants with >=3 tacrolimus levels.|12 months||||standard deviation units||Inter-Quartile Range|Median
2685786|NCT01356277|Primary|Timing Adherence|"Daily timing adherence, defined as the percentage of doses taken within 1 hour before to 2 hours after the prescribed dosing time each day (as measured by electronic monitoring). The daily timing adherence score could take a value of 0%, 50%, or 100% for patients on twice daily dosing, and 0% or 100% for patients on once daily dosing. Each patient had a timing adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use (due to travel etc), no score was given.~To summarize timing adherence for each arm, we calculated the total percentage of days of observation for which there was 100% timing adherence. The denominator for this calculation was the the total number of days of observation of each participant, summed across all participants; the numerator was the total number of days of observation of each participant for which timing adherence was 100%, summed across all participants."|12 months|We used unadjusted ordinal logistic regression with generalized estimating equations to account for repeated measures (i.e. score on each day) to compare timing adherence between the intervention and control groups during the intervention interval. An additional ‘as-treated’ analysis was also conducted. All available data were included.|||% of days with 100% timing adherence|||Number
2685787|NCT01356277|Primary|Taking Adherence|"Daily taking adherence, defined as the percentage of prescribed doses taken each day (as measured by electronic monitoring). The daily taking adherence score could take a value of 0%, 50%, or 100% for patients on twice daily dosing, and 0% or 100% for patients on once daily dosing. Each patient had a taking adherence score for every day of observation (repeated measures). On days that the pillbox was not in use due to technical problems or participant non-use (due to travel etc), no score was given.~To summarize adherence for each arm, we calculated the total percentage of days of observation for which there was 100% taking adherence. The denominator for this calculation was the the total number of days of observation of each participant, summed across all participants; the numerator was the total number of days of observation of each participant for which taking adherence was 100%, summed across all participants."|12 months|We used unadjusted ordinal logistic regression with generalized estimating equations to account for repeated measures (i.e. score on each day) to compare taking and timing adherence between the intervention and control groups during the intervention interval. An additional ‘as-treated’ analysis was also conducted. All available data were included.|||% of days with 100% taking adherence|||Number
2685788|NCT01356147|Secondary|Number of Infants Requiring Ventilator Support|number of infants extubated during treatment/sham|7 days||||participants|||Number
2685789|NCT01356147|Secondary|Elimination of White Blood Cells and Bacteria From Tracheal Aspirate|Number of infants with Tracheal aspirate WBC present on review of smear at end of therapy Bacterial load judged on presence of positive or negative culture in Tracheal aspirate|During first week of treatment or until extubation whichever is earlier||||participants|||Number
2685790|NCT01356147|Primary|Percent Reduction in Oxygen Requirement From Baseline|Change in required supplemental oxygen from baseline or time to extubation from mechanical ventilation|First week of treatment or extubation||||percentage FiO2||Full Range|Mean
2685791|NCT01355978|Secondary|Safety and Device-related Adverse Events|Any adverse events reported during he study period.|Continuous from Study Day 2 through Study Day 6||||participants|||Number
2685792|NCT01355978|Secondary|Device Preference|"5-point Likert Scale completed at the end or the 5-day study period~- Preference Scale: 5 = Max preference (Prefer to use the test device), 1 = Min preference (Do not prefer to use the test device)"|At conclusion of subject's participation (up to two weeks)||||units on a scale||Full Range|Median
2685793|NCT01355978|Primary|Device Tidal Volume|Evaluate the mean test volume for three activity levels. Subjects completed five consecutive, 6-hour clinic days in which the NIOV system was worn continuously while at rest, during activities of daily living (ADLs).|Periodically over six hours x 5 days||||mL||Standard Deviation|Mean
2685794|NCT01355796|Secondary|Sputum Density|Difference from baseline in density of Pseudomonas aeruginosa colonization per gram of sputum,|baseline and 14 days|27 out of 30 subjects were able to give sputum on day 14 and only those subjects are included in this analysis|||Log colony forming units||95% Confidence Interval|Mean
2685795|NCT01355796|Primary|Change in FEV1 % Predicted From Baseline|Change from baseline in FEV1(maximal amount of air you can forcefully exhale in one second) % predicted|Baseline and 14 days||||percentage of predicted||95% Confidence Interval|Mean
2685796|NCT01355705|Secondary|Time-to-next Treatment||9 months||||days||Full Range|Median
2685797|NCT01355705|Secondary|Progression-free Survival (PFS)|"Progression-free survival (PFS) is alive and free from progression, per the modified International Myeloma Working Group Uniform Response Criteria, defined as any of:~Serum monoclonal protein ≥ 125% baseline and/or ≥ +0.5 g/dL from baseline,~Urine monoclonal protein ≥ 125% baseline and/or ≥ +200 mg/24 hour from baseline~New or increased bone lesions or plasmacytomas~Serum calcium > 11.5 mg/dL (attributed to increased plasma cells)"|9 months||||days||Full Range|Median
2685798|NCT01355705|Secondary|Duration of Response (DOR)||140 days||||days||Full Range|Median
2685799|NCT01355705|Primary|Response Rates After Amrubicin + Lenalidomide + Dexamethasone, Per International Myeloma Working Group Uniform Response Criteria|"Modified International Myeloma Working Group Uniform Response Criteria:~Complete (CR)=~Negative for monoclonal protein (MP) in urine (U) and serum (S) +~No tissue plasmacytomas (PC) +~<5% plasma cells (PCs) in marrow (M)~Stringent CR (sCR)= CR with normal light chain ratio+ no PCs in M~Near CR (nCR)= CR, except MP persists in U and S~Partial (PR)= S MP ≤50%, + U MP ≤90% or <200 mg/24 hours (hr)~Very Good PR (VGPR)= in S MP ≤90%, + U MP <100 mg/24 hr~Minimal (MR)=~S MP ≤51-75%, +~If light chain is excreted, reduced 50-89%/24 hr that is also >200 mg/24 hr, +~No increase in lytic bone lesions~Progressive disease (PD)= any of:~S MP ≥125% and/or ≥+0.5 g/dL,~U MP ≥125% and/or ≥+200 mg/24 hr~New or increased bone lesions/PC~S calcium >11.5 mg/dL (attributed to increased PCs)~PD after CR/sCR=~Reappearance of S or U MP~≥5% clonal PCs in M~New PC, lytic bone lesions, hypercalcemia~Stable Disease (SD)= Not CR, VGPR, MR, PR, or PD"|12 weeks||||percentage of participants|||Number
2687168|NCT01344356|Primary|Complication Rate|Number of participants with any adverse event|5 years|9 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up.|||Participants|||Count of Participants
2685800|NCT01355679|Secondary|Activity of Treatments Chosen Based on Progression Free Survival (PFS)|Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|1 year||||Days||95% Confidence Interval|Mean
2685801|NCT01355679|Secondary|Overall Response Rate (ORR) of Participants Using RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|1 year||||percentage of participants with PR or CR|||Number
2685802|NCT01355679|Secondary|Number of Participants With Adverse Events as a Measure of Safety|To determine the safety of allowing a molecular tumor board to determine individualized treatment plans|1 year||||participants|||Number
2685803|NCT01355679|Primary|Percentage of Participants That Are Able to Meet Feasibility Parameters.|"Feasibility parameter defined as: Enrollment onto study, quality mRNA obtained, gene chip completed, tumor board held, medical monitor review and approval, start of treatment by 21 days post biopsy/surgical resection date, and then completion of 1 cycle of therapy."|1 year|All subjects had soft tissue disease in which biopsy was possible. Two subjects were deemed ineligible due to benign tumor type after biopsy.|||percentage of participants|||Number
2685804|NCT01355627|Secondary|Percentage of Participants With Post-Surgical Non-Clinically Evident Post-Operative Pseudomeningocele|Non-clinically evident pseudomeningocele was defined as a cerebrospinal fluid accumulation found on a postoperative computerized tomography (CT) or magnetic resonance imaging (MRI) scan which fulfilled the following criteria according to the radiologist assessment before Day of Discharge: CT Scan-Fluid accumulation seen as Hypodense signal, MRI Scan-Fluid accumulation seen as Hypointense signal in T1-weighted image and/ OR Fluid accumulation seen as Hyperintense signal in T2-weighted image.|Assessment at least once prior to discharge from neurosurgical ward, with the expected discharge from neurosurgical ward after an average of 10 days (Up to 28 Weeks)|Full Analysis Population included all enrolled randomized patients.|||percentage of participants||95% Confidence Interval|Number
2685805|NCT01355627|Primary|Percentage of Participants With Clinically Evident Verified Post-Operative Cerebrospinal Fluid Leak or Clinically Evident Pseudomeningocele or Treatment Failure|An assessment was performed daily from randomization to Day of Discharge and at the Efficacy Follow-up visit at week 7 ± 1 week. Clinically evident cerebrospinal fluid leak was confirmed by: 1. Glucose concentration test and/or 2. β-2-transferrin test. A clinically evident pseudomeningocele was considered to be present post-operatively if the following criteria were fulfilled: 1. A subcutaneous, visible/palpable fluctuant fluid accumulation was noted at the site of the surgical incision or adjacent to it; 2. It is suspected the fluid accumulation is cerebrospinal fluid. A treatment failure was defined as application of a new and/or different treatment after application of the study treatment or a third application of (or part of) the selected study treatment on the outside of the dura.|Up to 8 Weeks (7 Weeks ± 1 Week)|Full Analysis Population included all enrolled randomized patients.|||percentage of participants||95% Confidence Interval|Number
2685806|NCT01355588|Secondary|Time to Reach Maximum Plasma Concentration (Tmax)||Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose||||hours||Full Range|Median
2685807|NCT01355588|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to Infinity (AUC 0-∞)||Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose||||ng*h/mL||Standard Deviation|Mean
2685808|NCT01355588|Primary|Area Under the Plasma Concentration-time Profile From Time Zero to the Last Quantifiable Post-dose (AUC 0-t)||Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose||||ng*h/mL||Standard Deviation|Mean
2685809|NCT01355588|Primary|Maximum Observed Plasma Concentration (Cmax)||Anytime at pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours (ketorolac tromethamine only), and 24 hours (ketorolac tromethamine only) post-dose||||ng/mL||Standard Deviation|Mean
2685810|NCT01355523|Secondary|Incidence of Postoperative Cognitive Dysfunction (POCD) App. 10 Weeks Postoperatively|"Calculations for POCD were based on normative data from 133 females aged 40-60 years. We evaluated changes from the preoperative baseline to the 2 postoperative test sessions. In controls we calculated mean and standard deviations (SD) of these differences. The mean change in this group may be taken as estimated learning effects. For the individual patients, we compared baseline scores with the 2- and 12-week postoperative test results, subtracted the average learning effect from the changes and divided the result by the SD of the control group to obtain a Z score for the 7 individual test outcomes. A large positive Z score indicated deterioration in cognitive function from baseline in patients. We defined a composite Z score as the sum of the 7 Z scores and normalized this using the SD for that sum in the controls. POCD was defined as a combined Z score >1.96 or a Z score >1.96 in at least 2 of the 7 subtests.~Units of measure = % of patients with YES to POCD"|App. 10 weeks postoperatively|Analysis includes only patients who completed all parts of the neuropsychological test battery at baseline and 10 weeks postoperatively.|||Percentage of patients|||Number
2685821|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Fatigue - Immediate Postoperative Period|"Fatigue on a Visual Analog Scale - filled out daily. A subjective feeling of fatigue was registered on a VAS going from no fatigue, equivalent to 0mm to worst possible fatigue, equivalent to 100mm.~Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively||||mm*day||Inter-Quartile Range|Median
2685834|NCT01355419|Secondary|Change in Physical Activity (Number of Steps/Day)Before and After CPAP Therapy in OSA Patients|Change in Physical activity (number of steps/day)before and after CPAP therapy in OSA patientsevaluated by actigraphy|baseline and at 3 months||||steps||Standard Deviation|Mean
2703728|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|6 weeks|||||||
2685811|NCT01355523|Secondary|Incidence of Postoperative Cognitive Dysfunction (POCD) App. 2 Weeks Postoperatively.|"Calculations for POCD were based on normative data from 133 females aged 40-60 years. We evaluated changes from the preoperative baseline to the 2 postoperative test sessions. In controls we calculated mean and standard deviations (SD) of these differences. The mean change in this group may be taken as estimated learning effects. For the individual patients, we compared baseline scores with the 2- and 12-week postoperative test results, subtracted the average learning effect from the changes and divided the result by the SD of the control group to obtain a Z score for the 7 individual test outcomes. A large positive Z score indicated deterioration in cognitive function from baseline in patients. We defined a composite Z score as the sum of the 7 Z scores and normalized this using the SD for that sum in the controls. POCD was defined as a combined Z score >1.96 or a Z score >1.96 in at least 2 of the 7 subtests.~Units of measure = % of patients with YES to POCD"|App. 2 weeks postoperatively|Analysis includes only patients who completed all parts of the neuropsychological test battery at baseline and 2 weeks postoperatively.|||Percentage of patients|||Number
2685812|NCT01355523|Secondary|HPER3 Genotype|A blood sample will be taken at inclusion and analysed for HPER3 genotype (4/4, 4/5, 5/5) and this will be investigated for a correlation with sleep, cognitive function and depressive symptoms 7 patients did not give blood samples|At inclusion = day-7||||Participants|||Number
2685813|NCT01355523|Secondary|Sleep Architecture|Actigraphy (total minutes asleep, sleep effectiveness, sleep latency, awakenings). A wrist actigraph will be worn from inclusion till 14 days postoperatively.|From inclusion till 14 days postoperatively|||||||
2685814|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Sleep Quality - Long-term Postoperative Period|"Subjective sleep on a Visual Analog Scale. Subjective sleep quality was registered on a VAS going from best possible sleep, equivalent to 0mm to worst possible sleep, equivalent to 100mm.~Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively||||mm*2 weeks||Inter-Quartile Range|Median
2685815|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Sleep Quality - Immediate Postoperative Period|"Subjective sleep score on Visual Analog Scale. Subjective sleep quality was registered on a VAS going from best possible sleep, equivalent to 0mm to worst possible sleep, equivalent to 100mm.~Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively||||mm*day||Inter-Quartile Range|Median
2685816|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Pain - Long-term Postoperative Period|"Pain on a Visual Analog Scale - filled out every 14th day. A subjective feeling of pain was registered on a VAS going from no pain, equivalent to 0mm to worst possible pain, equivalent to 100mm.~Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively||||mm*2 weeks||Inter-Quartile Range|Median
2685817|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Pain - Immediate Postoperative Period|"Pain on a Visual Analog Scale - filled out daily. A subjective feeling of pain was registered on a VAS going from no pain, equivalent to 0mm to worst possible pain, equivalent to 100mm.~Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively||||mm*day||Inter-Quartile Range|Median
2685818|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on General Well-being - Long-term Postoperative Period|"General well-being on a Visual Analog Scale - filled out every 14th day. A subjective feeling of general well-being was registered on a VAS going from very high well-being, equivalent to 0mm to very low well-being, equivalent to 100mm.~Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively||||mm*2 weeks||Inter-Quartile Range|Median
2685819|NCT01355523|Secondary|Area Under the Curve (AUC) for Data on General Well-being - Immediate Postoperative Period|"General well-being on a Visual Analog Scale - filled out daily. A subjective feeling of general well-being was registered on a VAS going from very high well-being, equivalent to 0mm to very low well-being, equivalent to 100mm.~Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively|Patients were only included in the analysis if they had completed daily VAS on anxiety for at least 8 days postoperatively. Single missing data were filled out using last observation carried forward.|||mm*day||Inter-Quartile Range|Median
2685820|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Fatigue - Long-term Postoperative Period|"Fatigue on a Visual Analog Scale - filled out every 14th day. A subjective feeling of fatigue was registered on a VAS going from no fatigue, equivalent to 0mm to worst possible fatigue, equivalent to 100mm.~Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively||||mm*2 weeks||Inter-Quartile Range|Median
2685831|NCT01355484|Primary|Physical Function|Measure is the percentage of subjects at day 84 with stair climb power change >=10% from their baseline value.|Day 84|Subjects included in the Full Analysis Set|||percentage of subjects||95% Confidence Interval|Number
2703729|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|26 weeks|||||||
2685822|NCT01355523|Secondary|Area Under the Curve (AUC) for Data on Sleepiness (KSS) - Long-term Postoperative Period|"Sleepiness measured by Karolinska Sleepiness Scale. KSS is a 9-point scale from 1 (very awake) to 9 (very sleepy) where a score of 7 or more reflects pathological sleepiness.~Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively||||Units on KSS*2 weeks||Inter-Quartile Range|Median
2685823|NCT01355523|Secondary|Area Under the Curve (AUC) for Data on Sleepiness (KSS) - Immediate Postoperative Period|"Sleepiness measured by Karolinska Sleepiness Scale. KSS is a 9-point scale from 1 (very awake) to 9 (very sleepy) where a score of 7 or more reflects pathological sleepiness.~Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily from inclusion till 8 days postoperatively||||Units on KSS*day||Inter-Quartile Range|Median
2685824|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Anxiety - Long-term Postoperative Period|"Anxiety measured by VAS (visual analog scale). Completed every 14th day. A subjective feeling of anxiety was registered on a VAS going from no anxiety, equivalent to 0mm to worst possible anxiety, equivalent to 100mm.~Patients were only included in the analysis if they had completed VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness in the long-term postoperative period (every 14th day).~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 1 %"|App. 14 days postoperatively till 10 weeks postoperatively|Patients were only included in the analysis if they had completed VAS on anxiety in the long-term postoperative period. Single missing data were filled out using last observation carried forward.|||mm*2 weeks||Inter-Quartile Range|Median
2685825|NCT01355523|Secondary|Area Under the Curve (AUC) for VAS Data on Anxiety - Immediate Postoperative Period|"Anxiety measured by VAS (visual analog scale). A subjective feeling of anxiety was registered on a VAS going from no anxiety, equivalent to 0mm to worst possible anxiety, equivalent to 100mm.~Patients were only included in the analysis if they had completed daily VAS on anxiety, sleep quality, general well-being, fatigue, pain and sleepiness for at least 8 days postoperatively.~Single missing data were filled out using last observation carried forward (LOCF). % of cases filled out by LOCF < 2 %"|Daily - from inclusion till 8 days postoperatively||||mm*day||Inter-Quartile Range|Median
2685826|NCT01355523|Primary|Intention to Treat (Overestimate) - Depression at One Point in the Study Period|"MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.~For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.~Rating scale:~No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50 For this analysis all missing MDI data have been analyzed as YES for depression."|Intention to treat (overestimate) - depression at one point in the study period (not baseline)|"All missing data have been analyzed as YES depression."|||participants|||Number
2685827|NCT01355523|Primary|Intention to Treat (Underestimate) - Depression at One Point in the Study Period|"MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.~For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.~Rating scale:~No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50 For this analysis all missing MDI data have been analyzed as NO depression."|Intention to treat (underestimate) - depression at one point in the study period (not baseline)|"All missing MDI data have been analyzed as NO depression."|||participants|||Number
2685828|NCT01355523|Primary|Per Protocol - Depression at One Point in the Study Period|"MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.~For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.~Rating scale:~No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50 This analysis includes only patients who have taken study medication as planned."|Per protocol - depression at one point in the study period (not baseline)|Includes only patients who have taken the study medication as planned|||participants|||Number
2685829|NCT01355523|Primary|Major Depression Inventory (MDI)- Depression at One Point in the Study|"MDI is a self-rating depression scale with 12 questions. MDI has previously been investigated in a Danish population. On a six-point Likert scale, the items measure how much time the symptoms have been present during the last 14 days. MDI is scored according to specific guidelines and can be used either as a rating scale or diagnostic instrument.~For inclusion we used the diagnostic instrument (depression was an exclusion criteria) and for all other MDI measurements we used the rating scale.~Diagnostic scale using the ICD-10 algorithm:~Mild depression: 2 core symptoms and 2 other symptoms Moderate depression: 2 core symptoms and 4 other symptoms Severe depression: 3 core symptoms and 5 other symptoms~Rating scale:~No depression - score from 0-20 Mild depression - score from 21-25 Moderate depression - score from 26-30 Severe depression - score from 31-50"|Depression at one point in the study (not including baseline) out of 4 measurements at app. day 21, day 35, day 63 and day 91 of the study.|Includes all patients who have completed at least one other MDI than baseline|||participants|||Number
2685830|NCT01355484|Primary|Lean Body Mass|Measure is the percentage of subjects at day 84 with lean body mass change >=0% from their baseline value.|Day 84|Subjects included in the Full Analysis Set|||percentage of subjects||95% Confidence Interval|Number
2703730|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|16 weeks|||||||
2685835|NCT01355419|Primary|Change in Total Sleep Time Before and After CPAP Therapy in Obstructive Sleep Apnea Patients|change in Total sleep time before and after CPAP therapy in obstructive sleep apnea patients, assessed by actigraphy|baseline and at 3 months||||minutes||Standard Deviation|Mean
2685836|NCT01355302|Secondary|Time to Progression (TTP)|The study was terminated prior to enrollment in Phase 2 so this outcome measure was not conducted.|Until disease progression or death for 3 years|The study was terminated prior to enrollment in Phase 2 so this outcome measure was not conducted.||||||
2685837|NCT01355302|Secondary|Overall Response Rate (ORR)|The study was terminated prior to enrollment in Phase 2 so this outcome measure was not conducted.|Until disease progression or death for 3 years|The study was terminated prior to enrollment in Phase 2 so this outcome measure was not conducted.||||||
2685838|NCT01355302|Primary|Time to Maximum Concentration (Tmax) of Golvatinib|Tmax was defined as the time at which Cmax was observed for golvatinib in combination with cisplatin and capecitabine.|Cycle 1 (Day -2); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), 24, and 48 hours after study treatment. Cycle 2 (Day 1); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), and 24 hours after study treatment.|Pharmacokinetic (PK) population: All participants in the Safety Population who had sufficient concentration data to derive one or more of the PK parameters. Participants with partial data were evaluated on a case-by-case basis to determine if sufficient data were available for meaningful PK analysis.|||Hours||Full Range|Median
2685839|NCT01355302|Primary|Number of Participants With a Treatment-Emergent Adverse Event (TEAE)|Safety assessments consisted of monitoring and recording all adverse events (AEs) and serious AEs; regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms (ECGs); and performance of physical examinations. A TEAE was defined as an adverse event (AE) that had an onset date, or a worsening in severity from Baseline (pretreatment), on or after the first dose of study drug up to 30 days after the date of last study treatment.|From date of first dose up to 30 days after the last dose of study treatment, up to approximately 1 year 1 month.|Safety Population included all participants who received at least one dose of study drug and who had at least one safety assessment after the first dose of study drug.|||Participants|||Number
2685840|NCT01355302|Primary|Maximum Concentration (Cmax) of Golvatinib|Blood samples were drawn to analyze the amount of golvatinib in the participant's serum. Maximum concentration refers to the maximum (or peak) serum concentration of study drug in the participant's system after administration of the study drug and prior to the administration of a second dose of the study drug. Results were expressed in nanograms/milliliter (ng/mL).|Cycle 1 (Day -2); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), 24, and 48 hours after study treatment. Cycle 2 (Day 1); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), and 24 hours after study treatment.|Pharmacokinetic (PK) population: All participants in the Safety Population who had sufficient concentration data to derive one or more of the PK parameters. Participants with partial data were evaluated on a case-by-case basis to determine if sufficient data were available for meaningful PK analysis.|||ng/mL||Full Range|Median
2685841|NCT01355302|Primary|Area Under The Concentration-Time Curve (AUC) From 0 to 24 Hours of Golvatinib|On days when pharmacokinetic (PK) samples were to be drawn, a predose blood sample was obtained prior to administration of golvatinib and capecitabine. After administration of study drugs, a second postdose blood sample was taken. The amount of golvatinib in the participant's blood was analyzed and the AUC was calculated. The AUC reflects the actual body exposure to drug after administration of a dose of the drug and is dependent on the rate of elimination of the drug from the body and the dose administered. Predose samples that were below the limit of quantitation (BLQ) or missing were assigned a numerical value of zero for the calculation of AUC. Any other BLQ concentrations were assigned a value of zero. Results were expressed in nanograms·hour/milliter (ng·h/mL).|Cycle 1 (Day -2); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), 24, and 48 hours after study treatment. Cycle 2 (Day 1); predose, 30 minutes, 1, 2, 3, 4, 8, 12 (if feasible), and 24 hours after study treatment.|Pharmacokinetic (PK) population: All participants in the Safety Population who had sufficient concentration data to derive one or more of the PK parameters. Participants with partial data were evaluated on a case-by-case basis to determine if sufficient data were available for meaningful PK analysis.|||ng·h/mL||Full Range|Median
2685842|NCT01355289|Secondary|Number of Participants Who Initiated Antiviral Treatment by Day 21 of Period A1 of Core Study|Blood draws were taken to monitor platelet counts during the first 21 days of study treatment. When a platelet count of greater than or equal to 100 X 10^9/L was attained, antiviral treatment was initiated.|Baseline to Day 21|Full analysis set (FAS), the group of all randomized participants of core study.|||Participants|||Count of Participants
2685843|NCT01355289|Primary|Number of Participants Who Achieved Platelet Response (Greater Than or Equal to 100 x 10^9/L) by Day 21 of Treatment Period A1 of Core Study|A responder was defined as a participant having a platelet count of greater than or equal to 100x10^9/L by Day 21 starting from an average baseline platelet count of greater than 20 x 10^9/L to less than or equal to 70 x 10^9/L.|Baseline to Day 21|Full analysis set (FAS), the group of all randomized participants of core study.|||Participants|||Count of Participants
2685844|NCT01355289|Secondary|Number of Participants Who Achieved Platelet Count Greater Than 30 X 10^9/L From Baseline to Day 21 During Treatment Period A1 of Core Study|Blood draws were taken to monitor platelet counts.|Baseline to Day 21|Full analysis set (FAS), the group of all randomized participants of core study.|||Participants|||Count of Participants
2685845|NCT01355289|Secondary|Change From Baseline of Local Platelet Count by Visit During Treatment Period A1 of Core Study|Missing platelet counts were imputed using last observation carried forward (LOCF) approach for subjects who achieved platelet response at prior visits.|Day 7 and Day 14|Full analysis set (FAS), the group of all randomized participants of core study.|||cells x 10^9/L||Standard Deviation|Mean
2685846|NCT01355224|Primary|Intention to Lose Weight - Combined Risk|Intention to lose 10lbs in the next 6 months on a 5-point likert scale (1-strongly disagree; 5-strongly agree). This was examined by study arm and by combined levels of feedback (e.g. elevated genetic risk and non-elevated lifestyle risk)|3 months from viewing obesity risk assessment||||units on a scale||95% Confidence Interval|Mean
2685847|NCT01355224|Primary|Intention to Lose Weight - Impact of Risk Status|Intention to lose 10lbs in the next 6 months measured on a 5-point likert scale (1-strongly disagree;5-strongly agree). This was examined by study arm and level of feedback received (high or elevated risk vs low or non-elevated risk).|3 months after viewing obesity risk assessment||||units on a scale||95% Confidence Interval|Mean
2685848|NCT01355224|Primary|Intentions to Lose Weight - Effect of Study Arm on Outcomes|Intention to lose 10lbs in the next 6 months was measured on a 5-point likert scale (1-strongly disagree;5-strongly agree). Responses were examined by study arm.|3 months after viewing obesity risk assessment||||units on a scale||95% Confidence Interval|Mean
2685849|NCT01355081|Secondary|Change From Baseline in Sheehan Disability Scale (SDS) Total Score After 8 Weeks of Treatment|The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the Baseline SDS total score as a covariate.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last Observation Carried Forward (LOCF).|||scores on a scale||Standard Error|Least Squares Mean
2685850|NCT01355081|Secondary|Clinical Global Impression Scale-Improvement (CGI-I) Score After 8 Weeks of Treatment|"The CGI-I assesses the clinician's impression of the participant's state of mental illness improvement and consists of one question for the investigator: Compared to his condition at the start of the study, how much has this patient changed? which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater severity of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. ANCOVA model was used with treatment as a fixed effect and the baseline CGI-Severity (CGI-S) score as a covariate."|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last Observation Carried Forward (LOCF).|||scores on a scale||Standard Error|Least Squares Mean
2685851|NCT01355081|Secondary|Change From Baseline in the Hamilton Depression Scale (HAM-D17) Total Score After 8 Weeks of Treatment|The HAM-D17 is a 17-item rating scale that assesses depressed mood, agitation and somatic symptoms of depression, rated on a 5-point scale from 0 (absent) to 4 (very severe) with a total score range from 0 to 52. Higher scores indicate greater severity of depression symptoms. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the baseline HAM-D17 score as a covariate.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last Observation Carried Forward.|||scores on a scale||Standard Error|Least Squares Mean
2685852|NCT01355081|Secondary|Percentage of Patients With MADRS Remission After 8 Weeks of Treatment|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Remission is defined as a MADRS Total Score ≤10.|Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation.|||percentage of participants|||Number
2685853|NCT01355081|Secondary|Percentage of Patients With MADRS Response After 8 Weeks of Treatment|MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Response is defined as a ≥50% decrease in the MADRS Total Score from Baseline.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug, who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation.|||percentage of participants|||Number
2685854|NCT01355081|Primary|Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score After 8 Weeks of Treatment|MADRS is a 10-item clinician rated scale that measures overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates that symptoms have improved. An analysis of covariance (ANCOVA) model was used with change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.|Baseline, Week 8|Participants from the Full Analysis Set (FAS), defined as all participants who were randomized and received at least 1 dose of study drug; who had data available for this outcome measure. One participant in the Vortioxetine 10 mg group was excluded due to a major protocol deviation. Last observation carried forward.|||scores on a scale||Standard Error|Least Squares Mean
2685855|NCT01355068|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||hr||Full Range|Median
2685856|NCT01355068|Secondary|Plasma Decay Half Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||hr||Standard Deviation|Mean
2685905|NCT01354314|Secondary|Neurocognitive Performance: Timed Gait - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by Timed Gait, three-trial average time (Z scores).|24 Weeks|Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.|||Z score||Standard Deviation|Mean
2685857|NCT01355068|Secondary|Extrapolated Area Under the Curve (AUC Percent [%] Extrap)|AUC%extrap is the percentage of AUC [0-∞] obtained by forward extrapolation. It is calculated as (AUC [0-∞] minus AUClast)*100/ AUC [0-∞], where AUC [0-∞] = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUClast is area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||Percent AUC||Standard Deviation|Geometric Mean
2685858|NCT01355068|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞])|AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure.|||ng*hr/mL||Standard Deviation|Geometric Mean
2685859|NCT01355068|Primary|Maximum Observed Plasma Concentration (Cmax)||0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose|PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng/mL||Standard Deviation|Geometric Mean
2685860|NCT01355068|Primary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).|0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours (hrs) post-dose|Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.|||ng*hr/mL||Standard Deviation|Geometric Mean
2685861|NCT01354990|Primary|Number of Participants With Concomitant Conditions||Up to approximately 28 months||||participants|||Number
2685862|NCT01354990|Primary|Number of Participants With Concomitant Therapies||Up to approximately 28 months||||participants|||Number
2685863|NCT01354990|Primary|Age of Participants Prescribed Sitagliptin||Up to approximately 28 months||||years||Standard Deviation|Mean
2685864|NCT01354990|Primary|Number of Participants With an Adverse Event||Up to approximately 28 months||||participants|||Number
2685865|NCT01354964|Secondary|Evaluated Expression of Pro-inflammatory Gene PAI-1|Adipose tissue macrophages will be isolated from subcutaneous abdominal adipose tissue, and will be quantified by fluorescence activated cell sorting (FACS) analysis. PAI-1 gene expression will be examined by real-time (rt-PCR) and will provide a measure of macrophage activation at baseline, at 2nd study visit (after treatment with Vitamin D to a goal level of ≥30 ng/ml), and at 3rd study visit (goal Vitamin D level of ≥50 ng/ml). The mRNA copy number is then compared with a reference gene copy number (5 commonly used house keeping genes [HKGs]) as a ratio, which is a measure of relative gene expression.|2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)|PAI-1 expression was measured in 7 (out of 11) participants in the Vitamin D group. For the placebo group, 6 of the 8 participants provided fat biopsy samples for the 2nd visit, and 4 participants provided for the 3rd visit due to loss to follow up, withdrawal, or difficulties in obtaining IV access.|||Ratio of mRNA copy numbers (PAI-1/5HKGs)||Standard Error|Mean
2685866|NCT01354964|Secondary|Evaluated Expression of Pro-inflammatory Gene iNOS|Adipose tissue macrophages will be isolated from subcutaneous abdominal adipose tissue, and will be quantified by fluorescence activated cell sorting (FACS) analysis. iNOS gene expression will be examined by real-time (rt-PCR) and will provide a measure of macrophage activation at baseline, at 2nd study visit (after treatment with Vitamin D to a goal level of ≥30 ng/ml), and at 3rd study visit (goal Vitamin D level of ≥50 ng/ml). The mRNA copy number is then compared with a reference gene copy number (5 commonly used house keeping genes [HKGs]) as a ratio, which is a measure of relative gene expression.|2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)|iNOS expression was measured in 7 (out of 11) participants in the Vitamin D group. For the placebo group, 6 of the 8 participants provided fat biopsy samples for the 2nd visit, and 4 participants provided for the 3rd visit due to loss to follow up, withdrawal, or difficulties in obtaining IV access.|||Ratio of mRNA copy numbers (iNOS/5HKGs)||Standard Error|Mean
2685867|NCT01354964|Secondary|Evaluated Expression of Pro-inflammatory Gene IL-6|Adipose tissue macrophages will be isolated from subcutaneous abdominal adipose tissue, and will be quantified by fluorescence activated cell sorting (FACS) analysis. IL-6 gene expression will be examined by real-time (rt-PCR) and will provide a measure of macrophage activation at baseline, at 2nd study visit (after treatment with Vitamin D to a goal level of ≥30 ng/ml), and at 3rd study visit (goal Vitamin D level of ≥50 ng/ml). The mRNA copy number is then compared with a reference gene copy number (5 commonly used house keeping genes [HKGs]) as a ratio, which is a measure of relative gene expression.|2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)|IL-6 expression was measured in 7 (out of 11) participants in the Vitamin D group. For the placebo group, 6 of the 8 participants provided fat biopsy samples for the 2nd visit, and 4 participants provided for the 3rd visit due to loss to follow up, withdrawal, or difficulties in obtaining IV access.|||Ratio of mRNA copy numbers (IL-6/5HKGs)||Standard Error|Mean
2685868|NCT01354964|Secondary|Evaluated Expression of Pro-inflammatory Gene TNF-α|Adipose tissue macrophages will be isolated from subcutaneous abdominal adipose tissue, and will be quantified by fluorescence activated cell sorting (FACS) analysis. TNF-α gene expression will be examined by real-time (rt-PCR) and will provide a measure of macrophage activation at baseline, at 2nd study visit (after treatment with Vitamin D to a goal level of ≥30 ng/ml), and at 3rd study visit (goal Vitamin D level of ≥50 ng/ml). The mRNA copy number is then compared with a reference gene copy number (5 commonly used house keeping genes [HKGs]) as a ratio, which is a measure of relative gene expression.|2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)|TNF-α expression was measured in 7 (out of 11) participants in the Vitamin D group and in 4 (out of 8) participants in the placebo group at the 3rd study visit due to loss to follow up, withdrawal, or difficulties in obtaining IV access. Additionally, 2 participants in placebo group did not provide fat biopsy samples for the study.|||Ratio of mRNA copy numbers (TNF-α/5HKGs)||Standard Error|Mean
2685869|NCT01354964|Secondary|Percent Change in Peripheral Glucose Uptake|The rate of glucose uptake to determine peripheral insulin sensitivity was measured using the rate of disappearance (Rd) of glucose at each study visit. Percent change between the Rd at baseline and second visit (after treatment with Vitamin D for up to 3 months to target level of ≥30 ng/ml), and baseline and third visits (after treatment with Vitamin D for up to 6 months to target level of ≥50 ng/ml) will be calculated.|2nd clamp visit (up to 3 months) and 3rd clamp visit (up to 6 months)|Hepatic insulin sensitivity was measured in 7 (out of 11) participants in the Vitamin D group and in 6 (out of 8) participants in the placebo group at the 3rd study visit due to loss to follow up, withdrawal, or difficulties in obtaining IV access.|||percent change||Standard Error|Mean
2685870|NCT01354964|Primary|Percent Change in Hepatic Insulin Sensitivity|Endogenous glucose production (EGP) was assessed at each study visit to evaluate hepatic insulin sensitivity. Percent change between the EGP at baseline and second visit (after treatment for up to 3 months with Vitamin D to reach a target level of ≥30 ng/ml), and baseline and third visits (after treatment for up to 6 months with Vitamin D in order to reach a target level of ≥50 ng/ml) will be calculated.|2nd clamp visit (after up to 3 months) and 3rd clamp visit (after up to 6 months)|Hepatic insulin sensitivity was measured in 7 (out of 11) participants in the Vitamin D group and in 7 (out of 8) participants in the placebo group at the 3rd study visit due to loss to follow up, withdrawal, or difficulties in obtaining IV access.|||percent change||Standard Error|Mean
2685871|NCT01354951|Secondary|To Correlate Post-treatment MRI Findings With Post-treatment Biopsy Outcomes|Post-treatment MRI outcome is defined as a 3-level categorical variable: positive, negative and undetermined. Post-treatment biopsy outcome is defined as a binary variable: positive and negative. We will examine the correlation between the 12-month MRI and 12-month biopsy, and between the 24-month MRI and 24-month biopsy. The correlation will be assessed by a Fisher exact test.|2 years|Data not collected||||||
2685872|NCT01354951|Secondary|To Evaluate the Change From Baseline in QOL Indicators|Following focal brachytherapy in patients with early stage low volume localized prostate cancer. The scales to measure these domains were derived from the previously validated MSKCC Prostate-Health Related Quality of Life Questionnaire (PHRQOLQ|baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment|Data not collected||||||
2685873|NCT01354951|Secondary|To Evaluate the Local Tumor Control After Focal Brachytherapy|"as measured by the ability to obtain all negative biopsy cores 12 and 24 months after completion of therapy in the hemi-gland of where the focal therapy was administered. All negative means no prostate cancer;"|12 and 24 months|Data not collected||||||
2685874|NCT01354951|Primary|To Assess the Late Toxicity Outcomes|focal brachytherapy in patients with low risk prostate cancer This study will utilize the toxicity grading scale Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|6 months to 2 years|Data not collected||||||
2685875|NCT01354938|Primary|Number of Participants With a Minimal Clinically Important Difference (MCID) in SGRQ Total Score at End of Treatment|The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ subscores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. The change from Baseline of 4 or more units lower, consistent with a clinically significant change in the participant, was considered in this study to be the 'minimal clinically important difference' (MCID).|Baseline, End of Treatment (maximum treatment duration of 10 days)|Participants with evaluable data|||participants|||Number
2685876|NCT01354938|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|AE=any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment. SAE=an event meeting any of the following criteria: results in death, hospitalization, prolongation of hospitalization, is life-threatening, congenital anomaly, persistent or significant disability/incapacity, important medical event requiring medical or surgical intervention, spontaneous or elective abortion. AEs and SAEs were collected during the course of the study. See the Reported Adverse Event section for details.|From start of treatment (maximum treatment duration was 10 days) through last follow up visit (3 to 4 weeks after end of treatment)|All enrolled participants|||participants|||Number
2685877|NCT01354938|Primary|St. George's Respiratory Questionnaire (SGRQ) Scores at Baseline and End of Treatment|The SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a Total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The Total score and each of the SGRQ subscores are scored from 0 to 100 where 0 indicates best and 100 indicates worst health. An increase in score indicates worsening health. A change in the Total score of 4 units is consistent with a clinically significant change in the participant.|Baseline, End of Treatment (maximum treatment duration of 10 days)|Participants with evaluable data|||units on a scale||Standard Deviation|Mean
2685878|NCT01354899|Secondary|Overall Experience of Use of the Dressing|Overall experience of use of the dressing rated on a scale from Very Poor, Poor, Good, Very Good, Excellent|During 5 days||||participants|||Number
2685879|NCT01354899|Primary|Erythema (No/Yes)|Measure number of skin breakdown during from enrolment to termination.|During 5 days||||participants|||Number
2685880|NCT01354652|Secondary|Overall OLT-free Survival|Overall OLT-free survival until development of OLT and death and participants will be followed for the duration of hospital stay or outpatients visit, an expected average of 12 months|Participants will be followed for the duration of hospital stay or outpatients visit, an expected average of 12 months||||day||Standard Deviation|Mean
2685881|NCT01354652|Secondary|Arterial pH and Anion Gap in Cases With Elevated Blood Lactate Levels (at the Time of Detection and Peak Levels|Arterial pH and anion gap in cases with elevated blood lactate levels (at the time of detection and peak levels until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|Participants will be followed for the duration of hospital stay, an expected average of 8 weeks|Secondary outcome assessment was not performed due to early termination of the study.||||||
2703731|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|14 weeks|||||||
2685882|NCT01354652|Secondary|Frequency of Concomitant Prescribed Medications Possibly Associated With Lactic Acidosis Other Than NTRIs|Frequency of concomitant prescribed medications possibly associated with lactic acidosis other than NTRIs until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|Participants will be followed for the duration of hospital stay, an expected average of 8 weeks|Secondary outcome assessment was not performed due to early termination of the study.||||||
2685883|NCT01354652|Secondary|Incidence of Elevated Venous Lactate Levels More Than 2 mmol/L Caused by Etiologies Other Than NTRIs|incidence of elevated venous lactate levels more than 2 mmol/L caused by etiologies other than NTRIs until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|Participants will be followed for the duration of hospital stay, an expected average of 8 weeks|Secondary outcome assessment was not performed due to early termination of the study.||||||
2685884|NCT01354652|Secondary|Incidence of Elevated Venous Lactate Levels More Than 2 mmol/L Directly Related to NRTI|incidence of elevated venous lactate levels more than 2 mmol/L directly related to NRTI until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|Participants will be followed for the duration of hospital stay, an expected average of 8 weeks|Secondary outcome assessment was not performed due to early termination of the study.||||||
2685885|NCT01354652|Primary|Incidence of Elevated Venous Lactate Levels More Than 2 mmol/L of Any Etiology|incidence of elevated venous lactate levels more than 2 mmol/L of any etiology until development of lactic acidosis, orthotropic liver transplantation (OLT), death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.|participants will be followed for the duration of hospital stay, an expected average of 8 weeks|Our study was terminated early with only 5 participant enrolled. We gained lactic acid levels for the 5 patients (all elevated), however we considered that it was not sufficient to be analyzed. Morover, we did not further investigate the etiology for elevated lactic acid levels and secondary etiology-based outcomes are not recorded here.|||participants|||Number
2685886|NCT01354496|Secondary|Pharmacokinetics, Concentration Maximum (Cmax): Low and High Particle Size to Medium Particle Size||Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)|Randomized participants in Cohort 2 who received the specified study drug.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2685887|NCT01354496|Secondary|Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Low and High Particle Size to Medium Particle Size|AUC from time 0 to infinity (AUC0-∞).|Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)|Randomized participants in Cohort 2 who received the specified study drug.|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2685888|NCT01354496|Secondary|Pharmacokinetics, Time to Maximum Concentration (Tmax)||Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)|Randomized participants in Cohorts 1 and 2 who received the specified study drug.|||hour (hr)||Full Range|Median
2685889|NCT01354496|Secondary|Pharmacokinetics, Maximum Concentration (Cmax): Standardized High Fat Meal to Fasting||Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)|Randomized participants in Cohort 1 who received the specified study drug.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2685890|NCT01354496|Secondary|Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Standardized High Fat Meal to Fasting|AUC from time 0 to infinity (AUC0-∞).|Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)|Randomized participants in Cohort 1 who received the specified study drug.|||nanograms*hour/milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2685891|NCT01354496|Primary|Pharmacokinetics, Maximum Concentration (Cmax): Medium Test Form to Reference Form||Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)|Randomized participants in Cohort 1 who received the specified study drug.|||nanograms per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2685892|NCT01354496|Primary|Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Medium Test Form to Reference Form|AUC from time 0 to infinity (AUC0-∞).|Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)|Randomized participants in Cohort 1 who received the specified study drug.|||nanograms*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2685893|NCT01354444|Secondary|Effect of Carvedilol Treatment in Cerebrospinal Fluid (CSF) Levels of Amyloid-beta Oligomers|The investigators will measure CSF Abeta oligomer levels before and after 6 months randomized placebo-controlled double-blind treatment with carvedilol at a target dose of 25 mg daily, comparing the change in levels in 6 AD participants taking carvedilol vs. 10 AD participants taking placebo. These 16 participants had both baseline and 6 month CSF collected (of the entire study population).|6 months||||ng/mL||Standard Deviation|Mean
2685894|NCT01354444|Secondary|Effect of Carvedilol Treatment in Cerebrospinal Fluid (CSF) Levels of Amyloid-beta Oligomers|The investigators will measure CSF Abeta oligomer levels before and after 6 months randomized placebo-controlled double-blind treatment with carvedilol at a target dose of 25 mg daily, comparing the change in levels in 6 AD participants taking carvedilol vs. 10 AD participants taking placebo. These 16 participants had both baseline and 6 month CSF collected (of the entire study population). CSF was collected at the baseline visit and 6 months later.|6 months||||pg/mL||Standard Deviation|Mean
2685895|NCT01354444|Primary|Hopkins Verbal Learning Test (HVLT) Scores at Baseline, 3, and 6 Months|The investigators measured episodic memory (as evidence by the Hopkins Verbal Learning Test (HVLT)) before and after 6 months randomized placebo-controlled double-blind treatment with carvedilol at a target dose of 25 mg daily. Changes in HVLT Immediate and Delayed Recall score in 14 Alzheimer's Disease (AD) participants taking carvedilol vs. 15 AD participants taking placebo were compared. HVLT test score ranges are as follows: immediate recall (0-24) delayed recall (0-12). Higher scores indicate better episodic memory recall.|Baseline, 3 months, and 6 months||||Scores on a scale||Standard Deviation|Mean
2685896|NCT01354431|Secondary|Median Progression Free Survival (PFS) in Months at Interim Data Cut-off - Randomized Population|PFS: the time from randomization to the date of first disease progression (either clinical or radiographic progression, as assessed by the investigator) was measured in Months. Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. PFS was calculated based on investigator's assessment of first date of progression (either clinical or radiographic progression) or date of death if progression did not occur. Participants were censored if they had not experienced disease progression (they were still on treatment or in follow-up) or had received subsequent cancer therapy. Disease Progression was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions.|From Randomization to approximately 4 years post randomization|All Randomized participants were summarized up to March 2015 data cut off. Study on-going.|||Months||80% Confidence Interval|Median
2685897|NCT01354431|Secondary|Median Overall Survival in Months at Interim Data Cut-off - Randomized Population|Median Overall Survival (OS), measured in months, was based on Kaplan Meier estimates.|From Randomization to approximately 4 years post randomization|All Randomized participants were summarized up to interim data cut off, March 2015. Study on-going.|||Months||80% Confidence Interval|Median
2685898|NCT01354431|Secondary|Number of Participants With Best Overall Response at Primary Endpoint - Randomized Population|Best response defined as the best response across all time points. Primary endpoint=116 events, approximately 2 years. Tumor response was evaluated by investigator according to RECIST version 1.1. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm; partial response (PR): at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Disease Progression (PD) was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions; Stable disease: neither shrinkage to qualify for PR or increase to qualify for PD.|From randomization until after approximately 116 events (disease progression or death), approximately 2 years.|All Randomized participants were summarized up to Primary endpoint data cut off, approximately 2 years.|||participants|||Number
2685899|NCT01354431|Secondary|Objective Response Rate (ORR) at Primary Endpoint- Randomized Population|Tumor response was evaluated by investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Objective response rate (ORR) was defined as the number of responders divided by the number of randomized participants; Responders=complete response (CR) or partial response (PR). CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm; PR: at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR was estimated along with exact 80% Confidence Interval (CI) using the Clopper and Pearson method.|From randomization until after approximately 116 events (disease progression or death), approximately 2 years.|All randomized participants were analyzed up to Primary endpoint, approximately 2 years.|||percentage of participants||80% Confidence Interval|Number
2685900|NCT01354431|Primary|Median Progression Free Survival (PFS) at Primary Endpoint - Randomized Population|PFS: time from randomization to date of first disease progression (either clinical or radiographic progression, as assessed by the investigator) and measured in Months. Tumor assessments (radiographic scans) were done every 6 weeks from randomization for the first 12 months, then every 12 weeks until progression. Survival was assessed every 3 months. The analysis of PFS was conducted after approximately 116 events (progression or death), approximately 2 years. PFS was calculated based on investigator's assessment of first date of progression (either clinical or radiographic progression) or date of death if progression did not occur. Progression was at least a 20% increase in the sum of diameters of the longest target lesions since screening (the sum must be an absolute increase of at least 5 mm), or measurable increase in non-target lesion or appearance of one or more new lesions.|From randomization until after approximately 116 events (disease progression or death), approximately 2 years.|All participants who were randomized to a treatment arm.|||Months||80% Confidence Interval|Median
2685901|NCT01354314|Secondary|Change in CES-D Score - Per Protocol|Functional assessment: Change in Center for Epidemiologic Studies Depression Scale (CES-D) score between baseline and week 24 for all participants for whom baseline and follow-up CES-D data are available (per protocol).|24 Weeks|Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.|||units on a scale||Standard Deviation|Mean
2685902|NCT01354314|Secondary|Change in CES-D Score - Intent to Treat|Functional assessment: Change in Center for Epidemiologic Studies Depression Scale (CES-D) score between baseline and week 24 for all participants for whom baseline and follow-up CES-D data are available (intent to treat analysis).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.|||units on a scale||Standard Deviation|Mean
2685903|NCT01354314|Secondary|Neurocognitive Performance: NPZ-8 - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by NPZ-8 scores calculated for all participants who completed the trial with measurable Baseline and Week 24 data for at least 6 of the 8 data points. The data points that comprise the NPZ-8 include timed gait, symbol-digit, grooved pegboard dominant and non-dominant, CalCAP Choice reaction time and Sequential reaction time, Trail-making Test A and B. The baseline to week 24 changes for each test were averaged to get each change in NPZ-8 score.|24 Weeks|Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.|||Z score||Standard Deviation|Mean
2685904|NCT01354314|Secondary|Neurocognitive Performance: NPZ-8 - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by NPZ-8 scores calculated for all participants who completed the trial with measurable Baseline and Week 24 data for at least 6 of the 8 data points. The data points that comprise the NPZ-8 include timed gait, symbol-digit, grooved pegboard dominant and non-dominant, CalCAP Choice reaction time and Sequential reaction time, Trail-making Test A and B. The baseline to week 24 changes for each test were averaged to get each change in NPZ-8 score.|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.|||Z score||Standard Deviation|Mean
2685906|NCT01354314|Secondary|Neurocognitive Performance: Timed Gait - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by Timed Gait, three-trial average time (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.|||Z score||Standard Deviation|Mean
2685907|NCT01354314|Secondary|Neurocognitive Performance: Symbol-Digit Test - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by Symbol-Digit Test score, number correct in 120 seconds (Z scores).|24 Weeks|Per protocol analysis: Includes participants who completed the study per protocol and with test data available (no data substitution) at the Baseline and Week 24 visits.|||Z score||Standard Deviation|Mean
2685908|NCT01354314|Secondary|Neurocognitive Performance: Symbol-Digit Test - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by Symbol-Digit Test score, number correct in 120 seconds (Z scores).|24 Weeks|Includes all participants who completed the study with test data available (no data substitution) at the Baseline and Week 24 visits for Intention to Treat analysis.|||Z score||Standard Deviation|Mean
2685909|NCT01354314|Secondary|Neurocognitive Performance: CalCAP, Sequential - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Sequential test, mean reaction time (Z scores).|24 Weeks|Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.|||Z score||Standard Deviation|Mean
2685910|NCT01354314|Secondary|Neurocognitive Performance: CalCAP, Sequential - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Sequential test, mean reaction time (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.|||Z score||Standard Deviation|Mean
2685911|NCT01354314|Secondary|Neurocognitive Performance: CalCAP, Choice - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Choice test, mean reaction time (Z scores).|24 Weeks|Per protocol analysis: Includes participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.|||Z score||Standard Deviation|Mean
2685912|NCT01354314|Secondary|Neurocognitive Performance: CalCAP, Choice - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by the CalCAP Choice test, mean reaction time (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.|||Z score||Standard Deviation|Mean
2685913|NCT01354314|Secondary|Neurocognitive Performance: Grooved Pegboard, Non-Dominant - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, non-dominant hand speed of completion (Z scores).|24 Weeks|Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.|||Z score||Standard Deviation|Mean
2685914|NCT01354314|Secondary|Neurocognitive Performance: Grooved Pegboard, Non-Dominant - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, non-dominant hand speed of completion (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.|||Z score||Standard Deviation|Mean
2685915|NCT01354314|Secondary|Neurocognitive Performance: Grooved Pegboard, Dominant - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, dominant hand speed of completion (Z scores).|24 Weeks|Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.|||Z score||Standard Deviation|Mean
2685916|NCT01354314|Secondary|Neurocognitive Performance: Grooved Pegboard, Dominant - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by the Grooved Pegboard test, dominant hand speed of completion (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.|||Z score||Standard Deviation|Mean
2685917|NCT01354314|Secondary|Neurocognitive Performance: Trail Making B - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part B speed of completion (Z scores).|24 Weeks|Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.|||Z score||Standard Deviation|Mean
2685918|NCT01354314|Secondary|Neurocognitive Performance: Trail Making B - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part B speed of completion (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.|||Z score||Standard Deviation|Mean
2685919|NCT01354314|Secondary|Neurocognitive Performance: Trail Making A - Per Protocol|Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part A speed of completion (Z scores).|24 Weeks|Per protocol analysis: Includes all participants who completed the study per protocol and with test data available at the Baseline and Week 24 visits.|||Z score||Standard Deviation|Mean
2685920|NCT01354314|Secondary|Neurocognitive Performance: Trail Making A - Intent to Treat|Baseline to Week 24 change in neurocognitive performance as measured by the Trail-making test, part A speed of completion (Z scores).|24 Weeks|Includes all participants who completed the study with test data available at the Baseline and Week 24 visits for Intention to Treat analysis.|||Z score||Standard Deviation|Mean
2685921|NCT01354314|Secondary|Change in CSF Neurofilament Protein Heavy Chain (pNFH) Between Baseline and Week 24 - Per Protocol|CSF immune and neuronal injury markers: Change in CSF neurofilament protein heavy chain (pNFH) between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).|24 Weeks|For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.|||pg/mL||Inter-Quartile Range|Median
2685960|NCT01354132|Secondary|Glutamine Brain Level for Placebo Group|Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.|||mM||Standard Deviation|Mean
2685922|NCT01354314|Secondary|Change in CSF Neurofilament Protein Heavy Chain (pNFL) Between Baseline and Week 24 - Intent to Treat|CSF immune and neuronal injury markers: Change in CSF neurofilament protein heavy chain (pNFL) between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).|24 Weeks|31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.|||pg/mL||Inter-Quartile Range|Median
2685923|NCT01354314|Secondary|Change in CSF Neurofilament Protein Light Chain (NFL) Between Baseline and Week 24 - Per Protocol|CSF immune and neuronal injury markers: Change in CSF neurofilament protein light chain (NFL) between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).|24 Weeks|For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.|||pg/mL||Inter-Quartile Range|Median
2685924|NCT01354314|Secondary|Change in CSF Neurofilament Protein Light Chain (NFL) Between Baseline and Week 24 - Intent to Treat|CSF immune and neuronal injury markers: Change in CSF neurofilament protein light chain (NFL) between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).|24 Weeks|31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.|||pg/mL||Inter-Quartile Range|Median
2685925|NCT01354314|Secondary|Change in CSF CD163 Between Baseline and Week 24 - Per Protocol|CSF immune and neuronal injury markers: Change in CSF CD163 between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).|24 Weeks|For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.|||ng/mL||Inter-Quartile Range|Median
2685926|NCT01354314|Secondary|Change in CSF CD163 Between Baseline and Week 24 - Intent to Treat|CSF immune and neuronal injury markers: Change in CSF CD163 between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).|24 Weeks|31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.|||ng/mL||Inter-Quartile Range|Median
2685927|NCT01354314|Secondary|Change in CSF sCD14 Between Baseline and Week 24 - Per Protocol|CSF immune and neuronal injury markers: Change in CSF sCD14 between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).|24 Weeks|For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.|||pg/mL||Inter-Quartile Range|Median
2685928|NCT01354314|Secondary|Change in CSF sCD14 Between Baseline and Week 24 - Intent to Treat|CSF immune and neuronal injury markers: Change in CSF sCD14 between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).|24 Weeks|31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.|||pg/mL||Inter-Quartile Range|Median
2685929|NCT01354314|Primary|Change in CSF 3-nitrosylated Protein Levels Between Baseline and Week 24 - Per Protocol|CSF lipid and protein markers of oxidative stress: Change in 3-nitrosylated protein levels between baseline and week 24 for participants with 90% or greater adherence to study drug and for whom CSF data are available (per protocol analysis).|24 Weeks|For per protocol analysis, 18 participants (out of the total 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.|||pi*mm^2||Inter-Quartile Range|Median
2685930|NCT01354314|Primary|Change in CSF 3-nitrosylated Protein Levels Between Baseline and Week 24 - Intent to Treat|CSF lipid and protein markers of oxidative stress: Change in 3-nitrosylated protein levels between baseline and week 24 for all participants for whom CSF data are available (intent to treat analysis).|24 Weeks|For intention to treat analysis, 31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.|||pi*mm^2||Inter-Quartile Range|Median
2685931|NCT01354314|Primary|Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Per Protocol|CSF lipid and protein markers of oxidative stress: Change in CSF ceramide (C18:0 levels) between baseline and week 24 for participants with 90% or greater study drug adherence and for whom baseline and follow-up CSF data are available (per protocol analysis).|24 Weeks|For per protocol analysis, 18 participants (out of the 22 who completed the trial with 90% or greater study drug adherence) had follow-up CSF for primary outcome measures.|||ng/mL||Inter-Quartile Range|Median
2685932|NCT01354314|Primary|Change in CSF Ceramide Between Baseline and Week 24 (C18:0 Levels) - Intent to Treat|CSF lipid and protein markers of oxidative stress: Change in CSF ceramide (C18:0 levels) between baseline and week 24 for all participants for whom baseline and follow-up CSF data are available (intent to treat analysis).|24 Weeks|31 participants, out of the total 45 enrolled, completed the trial with follow-up CSF primary outcome measures.|||ng/mL||Inter-Quartile Range|Median
2685933|NCT01354223|Secondary|Evaluation of Average Lens Wearing Time - Average Daily Hours Worn|The secondary efficacy endpoint is the objective assessment of the lens average daily wearing times associated with the stenfilcon A compared with the lens average wearing times with the ocufilcon B contact lens. Objective average daily lens wearing time is measured in reported hours worn with the subject's habitual contact lenses recorded at baseline and after dispensing of study lenses recorded at Week 1, Week 2, Month 1, Month 2, Month 3.|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3||||hours||Standard Deviation|Mean
2685934|NCT01354223|Primary|Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better|"The primary efficacy endpoint are the contact lens Snellen visual acuities (VA) of 20/25 VA or better associated with stenfilcon A compared with those same visual acuities associated with ocufilcon B.~Snellen visual acuity (VA) examinations were performed at All Follow-up visits (week 1 visit, week 2 visit, month 1 visit, month 2 visit). The combined results of All Follow-up visits are compared."|week 1 visit, week 2 visit, month 1 visit, month 2 visit combined|For the completed study subjects, contact lens VA was collected at 562 of the possible 564 examinations (99.6%) for the Test cohort eyes and at 288 of the possible 288 examinations (100%) for the Control cohort eyes.|||percentage of possible examinations|Participants||Number
2685984|NCT01353976|Primary|Complete Cure|Complete Cure is defined as a negative KOH and negative fungal culture and no evidence of clinical disease as indicated by scores of 0 (none) for each sign and symptom at Day 43.|Day 43|MITT|||Participants|||Number
2685935|NCT01354223|Secondary|Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort|"The secondary efficacy endpoint is the subjective assessment of contact lens comfort associated with the stenfilcon A contact lens compared with the comfort associated with the ocufilcon B contact lens.~Subjective comfort assessment is related by the percent number of unique eyes that were reported to have no symptoms of discomfort (0=no symtoms reported) graded on a severity scale of the reported symptoms (0=no symptoms reported, 4=severe) that was experienced over the past month prior to baseline at the baseline visit (Baseline) and any symptoms of discomfort that was experienced since the previous study visit at each scheduled follow-up visit (Week 1, Week 2, Month 1, Month 2, Month 3)."|Baseline, Week 1, Week 2, Month 1, Month 2, Month 3|Unique eyes reporting no symptoms of discomfort/Pain, excessive tearing, photophobia, halos, itching/burning, dryness, variable vision, blurred vision, other symptoms.|||percentage of eyes|Participants||Number
2685936|NCT01354223|Primary|Comparison of Objective Findings - Number of Adverse Events in Unique Eyes|"The primary safety endpoint in this evaluation will be a comparison of the objective findings of the number of adverse events in unique eyes associated with the stenfilcon A contact lenses compared with those same findings as associated with ocufilcon B contact lenses.~The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence after dispensing (dispensing visit) through end of month 3 visit (month 3 visit)."|Any occurrence from dispensing to month 3 visit|Unique eyes are defined as each individual eye in the study.|||number of adverse events|Participants||Number
2685937|NCT01354223|Primary|Objective Assessment: Ocular Response - Biomicroscopy|"The primary safety endpoint are the objective slit lamp findings associated with the stenfilcon A contact lenses compared with those same findings reported as associated with the ocufilcon B contact lenses.~The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline (baseline visit) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit, month 2 visit combined).The average grade for unique eyes with findings greater than 0 (none) is compared."|Change from baseline visit and all follow-ups visits|Unique eyes are defined as each individual eye in the study and are only counted once for each of the visit groupings|||units on a scale|Participants|Full Range|Mean
2685938|NCT01354197|Secondary|Readmission to ICU|Number of Participants with Readmission to ICU up to 3 days (72 hours) after discharge from ICU|3 days||||participants|||Number
2685939|NCT01354197|Primary|Overall Mortality|Number of Participants who Did Not Survive up to 28 days after surgical ICU admission|28 days||||participants|||Number
2685940|NCT01354145|Secondary|Use of Acetaminophen|"Consumption of Acetaminophen: At each post-baseline visit, the investigator had to assess the consumption of acetaminophen, rescue analgesic authorised throughout the study, by reporting the number of caplets dispensed/retrieved since the previous visit.~Daily consumption of acetaminophen was calculated as an average."|3 months (Day 91), 6 momnths (Day 182), 12 months (Day 364), 18 monts (Day 546) and 24 months (Day 728)|Intention-To-Treat|||Daily number of caplets taken||Standard Deviation|Mean
2685941|NCT01354145|Secondary|Percentage of Participants With Presence of Joint Swelling and Effusion|Study knees were evaluated at each visit for the presence or absence of swelling and effusion.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||percentage of participants|||Number
2685942|NCT01354145|Secondary|Short Form (SF-36) Health Survey|"The SF-36 is composed of 35 items measuring:~8 health concepts (or dimensions), [(Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE) and Mental Health (MH)]~and 1 reported health transition item.~The 8 health concepts are summarized in 1 physical (PCS) and 1 mental (MCS) component summary measures. PCS is represented by physical function, role limitations-physical, pain, and general health perception. MCS is represented by vitality, social function, role limitations-emotional, and mental health. Subscale items are summed and scaled from 0-100 to give subscale scores; 0= worst health related quality of life (HRQL), 100=best HRQL. PCS and MCS summary scores are constructed as T-scores (mean =50, standard deviation=10) with no minimum or maximum score; higher scores indicate better health status."|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||Scores on a scales||Standard Deviation|Median
2685943|NCT01354145|Secondary|WOMAC Function Subscale|Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Function to 170 Maximum Function WOMAC functional limitation subscale was used to measure the functionality of the knee with pain. Seventeen items are used to assess functionality of the knee: tair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. Each item is a 10 cm VAS with 0 and 10 cm representing no difficulty and extreme difficulty respectively.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||centimeters||Standard Deviation|Mean
2685944|NCT01354145|Secondary|WOMAC Stiffness Subscale|Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Stiffness to 20 Maximum Stiffness WOMAC stiffness subscale was used to measure the stiffness of the knee with pain. Two items are used to assess stiffness grade: after first waking and later in the day.Each item is a 10 cm VAS with 0 and 10 cm representing no difficulty and extreme difficulty respectively.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||centimeters||Standard Deviation|Mean
2685945|NCT01354145|Secondary|WOMAC Pain Subscale|Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale Score Range: 0 (no pain) - 50 (maximum pain) The study was designed such that the outcome of primary interest is knee pain related to OA. The measure selected to best evaluate this is an improvement in the WOMAC pain subscales. This subscale consists of 5 items which assesses the pain during walking, using stairs, in bed, sitting or lying, and standing.Each item is a 10 cm VAS with 0 and 10 cm representing no pain and extreme pain respectively.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||centimeters||Standard Deviation|Mean
2685946|NCT01354145|Secondary|Visual Analog Scale (VAS)|"Visual Analogue Scale: 0 No Pain 10 Maximum Pain Huskisson's VAS measures global pain intensity. Patients were asked to quantify their disease status on a 10 cm VAS as follows: Please indicate the severity of knee pain experienced during the last 48 hours by marking a (I) through the line. Left hand marker represents No pain and right hand marker represents The worst pain imaginable."|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||centimeters||Standard Deviation|Mean
2685947|NCT01354145|Secondary|Percentage of Participants With the Presence of Extrusion in the Meniscus|The presence of a meniscal extrusion was assessed in each of sub regions. The absence of a severe extrusion in all the sub regions was considered as an absence (score=0) of a severe extrusion in the meniscus. The presence of a severe extrusion in at least one region of the meniscus was sufficient to consider the presence (score=1) of a severe extrusion in the meniscus.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||percentage of participants|||Number
2685948|NCT01354145|Secondary|Synovial Fluid Volume|To compare the synovial fluid volume of the global knee at the Baseline visit and after 24 months.|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||mililiters||Standard Deviation|Mean
2685949|NCT01354145|Secondary|Bone Marrow Lesions Score|"To compare the bone marrow lesions (BMLs) score in the global knee and the different sub regions at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB.~The BMLs were assessed in the global knee and the different sub region of the knee (medial trochlea, plateau of the medial femoro-tibial joint, femur of the medial femoro-tibial joint, medial posterior condyle, lateral trochlea, plateau of the lateral femoro-tibial joint, femur of the lateral femoro-tibial joint, lateral posterior femur). The BMLs score was defined as a grade (between 0 and 3) in each knee sub region and summed to derive a global knee score ranging between 0 (absent) and 30 (present). Specifically, each grade was scored as follows:~Grade 0 = Absence of lesion in the sub region~Grade 1 = less than 25% of the surface~Grade 2 = 25-50% of the surface~Grade 3 = more than 50% of the surface"|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||units on a scale||Standard Deviation|Mean
2685950|NCT01354145|Secondary|Synovial Membrane Thickness|"To compare the severity of synovitis score (Thickness of the Synovial Membrane in mm) in Global Knee , at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB.~The severity of synovitis was evaluated through four regions of interest (ROIs) in the images of the axial T1-weighted acquisition complemented with the use of the images of the axial T2-weighted acquisition. The thickness of the synovial membrane was evaluated in the global knee and each of the ROIs and results were expressed in millimetres. The four ROIs were the proximal lateral, distal lateral, proximal medial and distal medial."|Baseline, 12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||milimeters||Standard Deviation|Mean
2685951|NCT01354145|Secondary|Cartilage Volume in the Medial Compartment|To compare the cartilage volume loss of the medial compartment at the Baseline visit and after 12 and 24 months.|12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||cubic milimeters||Standard Deviation|Mean
2685952|NCT01354145|Secondary|Cartilage Volume Loss of the Global Knee|To compare the cartilage volume loss of the global knee at the Baseline visit and after 12 and 24 months.|12 months (Day 364) and 24 months (Day 728)|Intention-to-Treat|||cubic milimeters||Standard Deviation|Mean
2685953|NCT01354145|Primary|Cartilage Volume Loss of the Lateral Compartment|To compare the cartilage volume loss of the lateral compartment (femoral condyle and tibial plateau) at the Baseline visit and after 12 and 24 months of treatment either with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily or with CELECOXIB 200 mg daily.|12 months (Day 364) and 24 months (Day 728)|Intention-To-Treat|||cubic milimeters||Standard Deviation|Mean
2685954|NCT01354132|Secondary|Myo-Inositol Brain Level for Placebo Group|Myo-Inositol is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS)MRS and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.|||mM||Standard Deviation|Mean
2685955|NCT01354132|Secondary|Myo-Inositol Brain Level for the NAC Group|Myo-Inositol is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS)MRS and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.|||mM||Standard Deviation|Mean
2685956|NCT01354132|Secondary|Glutathione Brain Level for Placebo Group|measured by H-MRS in the medial prefrontal cortex Brain markers, glutathione was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.|||mM||Standard Deviation|Mean
2685957|NCT01354132|Secondary|Glutathione Brain Level for NAC Group|measured by H-MRS in the medial prefrontal cortex Brain markers, glutathione was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.|||mM||Standard Deviation|Mean
2685958|NCT01354132|Secondary|Glutamate Brain Level for Placebo Group|Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.|||mM||Standard Deviation|Mean
2685959|NCT01354132|Secondary|Glutamate Brain Level for NAC Group|Brain marker, glutamate, was measured using Magnetic Resonance Spectroscopy (H-MRS) in the medial prefrontal cortex. Glutamate is an excitatory neurotransmitter in the brain.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.|||mM||Standard Deviation|Mean
2685985|NCT01353963|Primary|Change From Baseline in Weight at Week 8.||Week 8|Safety population included all participants who received at least 1 dose of study medication during the observation period.|||kg||Standard Deviation|Mean
2685961|NCT01354132|Secondary|Glutamine Brain Level for NAC Group|Glutamine is measured in the medial prefrontal cortex using Magnetic Resonance Spectroscopy (H-MRS) and is a chemical that works to protect the brain from high levels of excitatory chemicals such as glutamate.|at 6 months|The number of subjects in the NAC and Placebo group is lower as not everyone in the study agreed to a MRS, in addition the MRS was only done at the Switzerland site.|||mM||Standard Deviation|Mean
2685962|NCT01354132|Secondary|GPxbc Glutathione Peroxidase Activity in Blood Cells|GPxBC is a measurement of glutathiione peroxidase enzymatic activity in glutathione synthesis and the redox system in blood cells. Measured as umol/min/gHb from blood cells.|at 6 months||||umol/min/gHb||Standard Deviation|Mean
2685963|NCT01354132|Secondary|Blood Plasma Level of Cysteine|Cysteine is an amino acid, a building block for proteins and is used throughout the body and was measured in blood plasma.|at 6 months||||uM||Standard Deviation|Mean
2685964|NCT01354132|Secondary|Change in Blood Level of Glutathione|Glutathione is a tripeptide comprised of three amino acids (cysteine, glutamic acid, and glycine) and acts as an antioxidant, a free radical scavanger and a detoxifying agent. Glutathione is an important co-factor for the enzyme glutathione peroxidase used in the uptake of amino acids. The level of glutathione is measured in blood cells.|at 6 months||||mM||Standard Deviation|Mean
2685965|NCT01354132|Secondary|Change in Cognition and Working Memory (MATRICS) Reasoning and Problem Solving|The MATRICS is neurocognitive battery designed to assess cognition. Problem Solving is a composite score based on the NAB Mazes. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.|at 6 months|Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.|||T- Scores||Standard Deviation|Mean
2685966|NCT01354132|Secondary|Change in Cognition and Working Memory (MATRICS) Visual Learning|The MATRICS is neurocognitive battery designed to assess cognition. Visual Learning is a composite score based on the Brief Visuospatial Memory test - Revised: Immediate Recall. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.|at 6 months|Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.|||T- Scores||Standard Deviation|Mean
2685967|NCT01354132|Secondary|Change in Cognition and Working Memory (MATRICS) Verbal Learning|The MATRICS is neurocognitive battery designed to assess cognition. Verbal Learning is a composite score based on the Hopkins Verbal Learning Test-Revised: Immediate Recall. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.|at 6 months|Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.|||T- Scores||Standard Deviation|Mean
2685968|NCT01354132|Secondary|Change in Cognition and Working Memory (MATRICS) Attention and Vigilance|The MATRICS is neurocognitive battery designed to assess cognition. Sustained attention and Vigilance is a composite score based on the Continuous Performance Test -Identical Pairs. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.|at 6 months|Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.|||T- Scores||Standard Deviation|Mean
2685969|NCT01354132|Secondary|Change in Cognition and Working Memory (MATRICS) Working Memory|The MATRICS is neurocognitive battery designed to assess cognition. Working Memory score is a composite score based on the following sub-test WMS-III Spatial Span and Letter-Number Span. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.|at 6 months|Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.|||T- Scores||Standard Deviation|Mean
2685986|NCT01353963|Primary|Change From Baseline in Weight at Week 4.||Week 4|Safety population included all participants who received at least 1 dose of study medication during the observation period.|||kilogram (kg)||Standard Deviation|Mean
2685987|NCT01353963|Primary|Change From Baseline in Heart Rate at Week 8.||Week 8|Safety population included all participants who received at least 1 dose of study medication during the observation period.|||bpm||Standard Deviation|Mean
2703732|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|8 weeks|||||||
2685970|NCT01354132|Secondary|Change in Cognition and Working Memory (MATRICS) Speed of Processing|The MATRICS is neurocognitive battery designed to assess cognition. Processing speed is a composite score including the following tests: Trail Making Test, BACS: Symbol Coding, Category Fluency: Animal Naming. The score is a standardized T-Score which indicates the number of standard deviations above or below the mean, a T-Score of 50, in 10 point increments. A T-Score of 60 indicates 1 standard deviation above the mean and a T-Score of 40 indicates 1 standard deviation below the mean. A score below 50 indicated cognitive processing below that of an age and gender matched healthy control population. A score above 50 indicates cognitive processing above that of an age and gender matched healthy control population.|at 6 months|Analysis of cognitive data is based on those who completed the cognitive testing at 6 months which required a separate clinic appointment and thus the overall number of participants is lower due to a loss of that data from failure to keep the cognitive testing appointment.|||T- Scores||Standard Deviation|Mean
2685971|NCT01354132|Secondary|Social and Occupational Functioning Assessment Scale (SOFAS)|"Measure of social and occupational functioning using the Social and Occupational Functioning Assessment Scale Measure Description: Rating of Overall Social and Occupational Functioning on a scale of 1 (worst) to 100 (best) in groups of 10:~100-91: Superior functioning 90-81: Good functioning 80-71: Slight impairment 70-61: Some difficulty 60-51: Moderate difficulty 50-41: Serious impairment 40-31: Major impairment 30-21: Inability to function in almost all areas 20-11: Unable to function independently 10-1: Unable to function without harming self or others"|at 6 months||||units on a scale||Standard Deviation|Mean
2685972|NCT01354132|Secondary|Global Assessment of Functioning (GAF)|"Measure Description: Clinical Measure of Global level of Symptoms (Sx) and Functioning from 1 (Worst) to 100 (Best) in groups of 10:~100 - 91: Superior functioning 90 - 81: Absent or minimal Sx 80 - 71: If symptoms are present and expected 70 - 61:Some mild Sx 60 - 51: Moderate Sx 50 - 41: Serious Sx 40 - 31: Some impairment in reality testing or communication 30 - 21: Behavior is considerably influenced by delusions or hallucinations 20 - 11: Some danger of hurting self or others 10 - 1: Persistent danger of severely hurting self or others"|at 6 months||||units on a scale||Standard Deviation|Mean
2685973|NCT01354132|Secondary|Change in Positive Symptoms (PANSS)|"Positive and Negative Symptom Scale was used to assess psychopathology. The Positive symptom subscale of schizophrenia includes the sum of items P1 -P7 including P1) Delusions, P2) conceptual Disorganization, P3) Hallunicatory Behavior, P4) Excitement, P5) Grandiosity, P6) Suspiciousness and Persecution, and P7) Hostility and were assessed for the previous week:~RATING SCALE~1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 7 and the highest possible score is 49 ."|at 6 months|Analysis was done with participants who completed the 6 month treatment phase|||units on a scale||Standard Deviation|Mean
2685974|NCT01354132|Primary|Change in Negative Symptoms of Schizophrenia as Measured on the PANSS|"Positive and Negative Symptom Scale was used to assess psychopathology. The sum of items N1 - N7 including N1) blunted affect, N2) emotional withdrawal, N3) poor rapport, N4) passive apathetic social withdrawal, N5) difficulty in abstract thinking, N6) lack of spontaneity and flow of conversation, and N7) sterotyped thinking were used to analyze negative symptoms of schizophrenia and were assessed for the previous week:~RATING SCALE~1: Absent 2: Minimal 3: Mild 4: Moderate 5: Moderate Severe 6: Severe 7: Extreme The higher the score the worse the symptoms. The lowest possible score is 7 and the highest possible score is 49 ."|at 6 months|Analysis was done with those who completed the 6 month treatment protocol.|||units on a scale||Standard Deviation|Mean
2685975|NCT01354106|Primary|Skin Trauma|"Expert grader using Erythema/Edema Scale 0=No visible response~mild response~moderate response~severe response~extreme response"|24 hours||||Units on a scale||Standard Deviation|Mean
2685976|NCT01354028|Primary|Number of Infants Sleeping at the End of the Massage Period|Investigators compared the number of infants sleeping at the end of the massage period with the percentage of infants sleeping at the same time on the non massage day.|Minute massage ended|A convenient number of infants was determined for this pilot study|||participants|||Number
2685977|NCT01354028|Secondary|Heart Rate|Heart rate during massage therapy|During massage therapy|A convenient size was determined for this pilot study|||beats per minute||Standard Deviation|Mean
2685978|NCT01354028|Secondary|Oxygen Saturation Levels During Massage|Infants in the NICU are routinely attached to pulse oximeter monitors that measure oxygen saturation continuously. If the infant is stressed, oxygen levels may drop. Oxygen saturation was monitored during massage therapy as a routine measure but also to ensure that infants did not become stressed during the massage.|During massage|We determined a convenient size for this pilot study|||percentage of oxygen saturation||Standard Deviation|Mean
2685979|NCT01354028|Primary|Quality of Sleep, Defined by Number and Duration of Awakenings, and Longest Sustained Sleep Period for the Study Interval. These Data Were Measured by the Actigraph Software and Summarized as Percentage of Time Spent Sleeping, or Sleep Efficiency|Sleep onset following the first quiet alert state after the 9 AM feed Sleep end time Number of awakenings and duration of the awakenings during the study period Longest sustained sleep period for the study interval Percentage of time spent sleeping, or sleep efficiency, will be used to summarize the data, comparing sleep efficiency over 2 days and using each infant as his/her own control|Participants were followed for two days|A convenient number of participants was selected for this pilot study.|||percentage of time spent sleeping||Standard Deviation|Mean
2685980|NCT01354015|Secondary|Change in HbA1c Over 3 Months|Change in HbA1c|baseline to 3 months|Of the 50 enrolled in the Use of DRMS group, only 46 completed the visit at 3 months, and out of 48 enrolled in the Usual Care group only 45 completed the visit at 3 months. Therefore only those who completed the visit at 3 months were included in this analysis.|||Percent||Standard Deviation|Mean
2685981|NCT01354015|Primary|Change in HbA1c|change in A1c from baseline in intervention and control groups|baseline to 6 months|Of the 50 enrolled in the Use of DRMS group, only 44 completed the visit at 6 months, and out of 48 enrolled in the Usual Care group only 43 completed the visit at 6 months. Therefore only those who completed the visit at 6 months were included in this analysis.|||Percent||Standard Deviation|Mean
2685982|NCT01353976|Secondary|Mycological Cure|Mycological Cure defined as negative KOH and negative culture at Day 43.|Day 43|MITT|||Participants|||Number
2685983|NCT01353976|Secondary|Effective Treatment|Effective Treatment defined as negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43.|Day 43|MITT|||Participants|||Number
2685989|NCT01353963|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8.||Week 8|Safety population included all participants who received at least 1 dose of study medication during the observation period.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2685990|NCT01353963|Primary|Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4.||Week 4|Safety population included all participants who received at least 1 dose of study medication during the observation period.|||millimeter of mercury (mmHg)||Standard Deviation|Mean
2685991|NCT01353963|Primary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug with regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between Week 4 and up to Week 8 that were absent before treatment or that worsened relative to pretreatment state.|Week 4 to Week 8|Safety population included all participants who received at least 1 dose of study medication during the observation period.|||Participants|||Number
2685992|NCT01353911|Secondary|Percentage of Participants Achieving Undetectable HCV RNA at Week 72|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Undetectable HCV RNA (target not detected [TND]) was defined as below the 9.3 IU/ml limit of detection. 95% confidence intervals provided based on the Clopper-Pearson method.|Week 72|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.|||percentage of participants||95% Confidence Interval|Number
2685993|NCT01353911|Secondary|Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of Study Therapy (SVR24)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR24 was defined as undetectable (TND) HCV RNA at 24 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|24 weeks after the end of all treatment (up to 72 weeks)|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.|||percentage of participants||95% Confidence Interval|Number
2685994|NCT01353911|Secondary|Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of Study Therapy (SVR12)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). SVR12 was defined as undetectable (TND) HCV RNA at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|12 weeks after the end of all treatment (up to 60 weeks)|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.|||percentage of participants||95% Confidence Interval|Number
2685995|NCT01353911|Secondary|Percentage of Participants Achieving Rapid Viral Response (RVR)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). RVR was defined as undetectable (TND) HCV RNA at Week 4 of study therapy. 95% confidence intervals provided based on the Clopper-Pearson method.|After 4 weeks of treatment with grazoprevir/boceprevir|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.|||percentage of participants||95% Confidence Interval|Number
2685996|NCT01353911|Secondary|Median Time to First Achievement of Undetectable HCV RNA During Treatment|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Undetectable HCV RNA (target not detected [TND]) was defined as below the 9.3 IU/ml limit of detection. Kaplan Meier summary statistics were calculated for each treatment arm.|From first dose of study medication until first achievement of undetectable HCV RNA (up to 48 weeks of treatment)|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens. Participants in the FAS not achieving TND were censored.|||days||95% Confidence Interval|Median
2686007|NCT01353859|Secondary|Time to Achieve DAS28 Remission (DAS28 <2.6)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 remission was defined as DAS28 <2.6. Time to achieve remission was calculated in weeks as the time from the date of first infusion to the date of first achieving remission.|Weeks 4, 8, 12, 16, 20 and 24|ITT Population|||weeks||Standard Deviation|Mean
2687186|NCT01343901|Secondary|Number of Cumulated Cycles of First Line Bevacizumab at Day 0||Day 0|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.|||cycles||Standard Deviation|Mean
2685997|NCT01353911|Primary|Number of Participants Who Discontinued Study Medication Due to AEs During the Treatment Period and First 14 Follow-up Days|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.|Treatment period plus the first 14 days of follow-up (up to 50 weeks)|APaT population; all randomized/enrolled who received ≥1 dose of study treatment according to treatment actually received. Participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.|||participants|||Number
2685998|NCT01353911|Primary|Number of Participants Experiencing Adverse Events (AEs) During the Treatment Period and First 14 Follow-up Days|An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, was also an AE.|Treatment period plus the first 14 days of follow-up (up to 50 weeks)|All Participants as Treated (APaT) population; all randomized/enrolled who received ≥1 dose of study treatment according to treatment actually received. Participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.|||participants|||Number
2685999|NCT01353911|Primary|Percentage of Participants Achieving Complete Early Viral Response (cEVR)|Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification of 25 IU/mL and a limit of detection of 9.3 IU/mL (in plasma). cEVR was defined as undetectable HCV RNA (target not detected [TND]) at Week 12. 95% confidence intervals provided based on the Clopper-Pearson method.|After 12 weeks of treatment with grazoprevir/boceprevir|FAS; all randomized/enrolled participants who received ≥1 dose of study treatment. A Missing = Failure approach was used for missing data. Results for participants who received grazoprevir 400 or 800 mg and were then down-dosed to receive grazoprevir 100 mg are reported separately from participants who completed the 400 mg and 800 mg regimens.|||percentage of participants||95% Confidence Interval|Number
2686000|NCT01353898|Primary|Change From Baseline to Day 10 in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Due to Treatment With MK-1972 or Placebo|Blood was collected at baseline and on Day 10, and the plasma concentration for HIV-1 RNA was determined using the Abbott RealTime HIV assay.|Baseline and Day 10 (24 hours post-dose)|All participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model.|||log10 copies/mL||Standard Error|Mean
2686001|NCT01353898|Secondary|The Area Under the Curve From 0-24 Hours (AUC0-24hrs) on Day 10 for Plasma Concentration of MK-1972 in Participants With HIV-1 Infection|Plasma concentration of MK-1972 was determined from blood collected from HIV-1 infected participants on Day 10 : pre-dose up to 24 hours post-dose in order to determine the AUC0-24hrs.|Day 10: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post-dose|All participants who comply with the protocol sufficiently to ensure that these data will be likely to exhibit the effects of treatment, according to the underlying scientific model. MK-1972 was not measured for the placebo group since it did not receive any of this drug.|||nM.hr||Geometric Coefficient of Variation|Geometric Mean
2686002|NCT01353898|Primary|Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs)|An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an adverse event.|From consent to 14 days after the last dose (up to Day 24)|All participants who received at least one dose of the investigational drug, according to the treatment they actually received.|||Participants|||Number
2686003|NCT01353859|Secondary|C-Reactive Protein Levels|CRP levels were measured in milligrams/liter (mg/L) and were used to determine the acute phase response. A reduction in CRP levels is considered an improvement; normal reference range ≤10 mg/L.|Baseline, Weeks 4, 8, 12,16, 20, and 24|ITT Population|||mg/L||Standard Deviation|Mean
2686004|NCT01353859|Secondary|Erythrocyte Sedimentation Rate|Erythrocyte Sedimentation rate was measured in mm/hour and was used to determine the acute phase response. Lower ESR values indicate reduction in disease activity; normal reference range: 0-20 mm/hr.|Baseline, Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||mm/hr||Standard Deviation|Mean
2686005|NCT01353859|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) 20%, 50%, and 70% Improvement (ACR20, ACR50, or ACR70) Response|ACR20/50/70 response was defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in swollen/tender joint count (66 joints assessed for swelling and 68 joints assessed for tenderness) as well as improvement in at least 3 of the 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the health assessment questionnaire [HAQ]); and acute phase response: C-reactive protein (CRP) or ESR.|Week 24|ITT Population|||percentage of participants|||Number
2686006|NCT01353859|Secondary|Percentage of Participants With DAS28 <3.2 by Visit|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||percentage of participants|||Number
2686286|NCT01351480|Secondary|Number of Patients With Adverse Events|site will report the number of patients with adverse envents from Day 1 up to 52 weeks|all adverse events will be captured from Day 1 up to 52 weeks|There were 34 enrolled patients with 7 patients who early termed so analysis was performed on 27 patients|||participants|||Number
2686008|NCT01353859|Secondary|Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Remission was defined as DAS28 <2.6.|Baseline and Weeks 4, 8, 12, 16, 20, and 24|ITT Population|||percentage of participants|||Number
2686009|NCT01353859|Secondary|Time to Clinically Significant Improvement in DAS28|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity; a clinically significant improvement is a reduction in DAS28 score of at least 1.2 units. Time to clinically significant improvement was determined in weeks from the date of first infusion to the date of first achievement of reduction of 1.2 units in DAS28.|Weeks 4, 8, 12, 16, 20 and 24|ITT Population|||weeks||Standard Deviation|Mean
2686010|NCT01353859|Secondary|Percentage of Participants With a Clinically Significant Improvement in DAS28 Score|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity; a clinically significant improvement in DAS28 score was defined as a reduction of at least 1.2 units.|Weeks 4, 8, 12, 16, 20 and 24|ITT Population|||percentage of participants|||Number
2686011|NCT01353859|Secondary|Time to Achieve Low Disease Activity (DAS28 ≤3.2)|DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 = low disease activity; time to low disease activity was calculated as the time in weeks from the date of first infusion to the first achievement of DAS28 ≤3.2|Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24|ITT Population|||weeks||Standard Deviation|Mean
2686012|NCT01353859|Primary|Percentage of Participants Achieving Low Disease Activity Score|Disease Activity Score using 28-Joint Count (DAS28) was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog scale [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) equals (=) low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.|Week 24|ITT population: All participants randomized in the study who received administration of at least one dose of the study drug and who had the last week 24 assessment performed.|||percentage of participants|||Number
2686013|NCT01353703|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|During the entire study period (from Month 0 up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group))|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Participants|||Count of Participants
2686014|NCT01353703|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|During the 31-day (Days 0-30) post-vaccination period: Up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.|||Participants|||Count of Participants
2686015|NCT01353703|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of any particular symptom regardless of intensity grade or relationship to study vaccination.|During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least one dose of the study vaccine, for whom data were available and who had the symptoms sheet filled in.|||Participants|||Count of Participants
2686016|NCT01353703|Secondary|Number of Subjects With Any Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of any particular symptom regardless of intensity grade.|During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)|The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least one dose of the study vaccine, for whom data were available and who had the symptoms sheet filled in.|||Participants|||Count of Participants
2686017|NCT01353703|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.|At Month 0|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.|||mIU/mL||95% Confidence Interval|Geometric Mean
2686018|NCT01353703|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|At Month 0|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2686347|NCT01350999|Secondary|Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C)||Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
2686019|NCT01353703|Secondary|Anti-Polio Types 1, 2 and 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|At Month 0|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.|||Titers||95% Confidence Interval|Geometric Mean
2686020|NCT01353703|Secondary|Number of Seroprotected Subjects Against Anti-HBs Antigens|A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.|At Month 0|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.|||Participants|||Count of Participants
2686021|NCT01353703|Secondary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN|A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.|At Month 0|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.|||Participants|||Count of Participants
2686022|NCT01353703|Secondary|Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens|A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).|At Month 0|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.|||Participants|||Count of Participants
2686023|NCT01353703|Secondary|Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN|A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.|One month post Dose 3 (Month 3 or Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.|||Participants|||Count of Participants
2686024|NCT01353703|Secondary|Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.|One month post Dose 3 (Month 3 or Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2686025|NCT01353703|Secondary|Anti-PRP Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.|One month post Dose 3 (Month 3 or Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.|||µg/mL||95% Confidence Interval|Geometric Mean
2686026|NCT01353703|Secondary|Anti-Polio Types 1, 2, 3 Antibody Titers|Antibody titers were presented as geometric mean titers (GMTs).|One month post Dose 3 (Month 3 or Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.|||Titers||95% Confidence Interval|Geometric Mean
2686027|NCT01353703|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).|One month post Dose 3 (Month 3 or Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.|||mIU/mL||95% Confidence Interval|Geometric Mean
2686028|NCT01353703|Secondary|Anti-D and Anti-T Antibody Concentrations|Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).|One month post Dose 3 (Month 3 or Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.|||IU/mL||95% Confidence Interval|Geometric Mean
2686029|NCT01353703|Primary|Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)|Vaccine response was defined as : For initially seronegative subjects (S-), antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at 1 month after the third dose; For initially seropositive subjects (S+): antibody concentration at 1 month after the third dose ≥ 1 fold increase in the pre-vaccination antibody concentration.|One month post Dose 3 (Month 3 or Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed and for whom pre-vaccination data was available for the considered assay.|||Participants|||Count of Participants
2686030|NCT01353703|Primary|Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens|A seroprotected subject was defined as a subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).|One month post Dose 3 (Month 3 or Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.|||Participants|||Count of Participants
2686031|NCT01353703|Primary|Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens|A seroprotected subject was defined as a subject with anti-Poliovirus 1,2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).|One month post Dose 3 (Month 3 or Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.|||Participants|||Count of Participants
2686032|NCT01353703|Primary|Number of Seroprotected Subjects Against Hepatitis B (HBs)|A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).|One month post Dose 3 (Month 3 or Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.|||Participants|||Count of Participants
2686348|NCT01350999|Secondary|Percent Change From Baseline in Total Cholesterol||Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
2686033|NCT01353703|Primary|Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens|A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|One month post Dose 3 (Month 3 or Month 5)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.|||Participants|||Count of Participants
2686034|NCT01353664|Primary|Summary of Participants With Treatment Emergent Adverse Events (TEAEs)|An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. Adverse events were assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4: On the following is the scale: Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = Severe and Undesirable AE, Grade 4 = Life-threatening or Disabling AE, and Grade 5 = Death. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention. A TEAE is defined as any AE occurring or worsening on or after the first dose of study drug and within 28 days after the last dose of study drug.|All AEs were recorded by the Investigator from the time the participant signed the informed consent to 28 days after the last dose of study drug; maximum drug exposure was 231 days|Safety Population = Participants who received at least one dose of study drug.|||Participants|||Number
2686035|NCT01353586|Secondary|Subpopulation Neurological Assessments (SNA) Endpoint 2 - Incidence of New Neurological Findings Post Ablation|All SNA subjects were to be evaluated by expert neurologists for existing neurological deficits prior to ablation procedure. After procedure, those subjects were also to be assessed for new neurological deficits.|48 hours post-ablation|Neurological assessment subpopulation. This population includes 19 subjects from the nMARQ main study and 17 subjects from the Thermocool control group.|||percentage of participants|||Number
2686036|NCT01353586|Secondary|Subpopulation Neurological Assessments (SNA) Endpoint 1 - Incidence of Cerebral Embolic (ACE) Lesions Post Ablation|Evaluation of post-ablation generation incidence of asymptomatic cerebral microembolic lesions post ablation, as documented by MRI. All microembolic lesions reported in this study are asymptomatic.|48 hours post-ablation|Neurological assessment subpopulation. This population includes 19 subjects from the nMARQ main study and 17 subjects from the Thermocool control group.|||percentage of subjects with ACE Lesion|||Number
2686037|NCT01353586|Secondary|Absence of Documented Symptomatic PAF Through 6 Months and 12 Months Post Procedure|This endpoint is defined as the absence of documented symptomatic PAF recurrence through 6 months and 12 months post index ablation procedure.|6 and12 months post study procedure|This analysis population is the effectiveness cohort, excluding 2 subjects who withdrew consent prior to Day 91. The effectiveness cohort includes those who received treatment with the investigational device; but does not include 20 workflow and 22 roll-in subjects.|||percentage of participants||95% Confidence Interval|Number
2686038|NCT01353586|Secondary|Incidence of Completion of Ablation Procedure|This secondary outcome describes the acute effectiveness, which is defined as pulmonary vein isolation (PVI) documented by confirmed entrance block (with or without the use of a focal catheter).|From 7 days to 12 months post study procedure|Safety population excluding one subject without source document at site|||percentage of participants||95% Confidence Interval|Number
2686039|NCT01353586|Secondary|Assessment of Pulmonary Vein (PV) Narrowing and Stenosis at 3 Months After Index Ablation|Incidence of narrowing of PV and stenosis at 3 months post ablation, for subjects with available CT/MRA scans at 3 months. PV Stenosis is defined as 70% or more PV diameter reduction.|Three months after index ablation|Subjects in safety analysis group who also had CT/MRI PV scan available at the 3-month post-ablation interval (144 of 160 subjects)|||percentage of participants with CT/MRI|||Number
2686040|NCT01353586|Secondary|Incidence of Non-Primary Serious Adverse Events (SAEs) up to 12 Months|This secondary safety endpoint includes non-primary serious adverse events within 7 days post-procedure and serious adverse events from 7 days to 12 months post-procedure.|12 months post study procedure|Safety population|||percentage of participants|||Number
2686041|NCT01353586|Primary|Incidence of Freedom From Documented Symptomatic Atrial Fibrillation|The primary effectiveness endpoint is freedom from documented symptomatic atrial fibrillation based on electrocardiographic data through 8 months post ablation.|Evaluated from Day 91 to Day 240|Effectiveness cohort: This population excludes those subjects who never underwent insertion of study catheter, those who terminated procedure prior to ablation, and those who were enrolled during the Workflow phase (20 subjects) and Roll-in phase (22 subjects). This analysis also excludes two subjects who withdrew consent post ablation.|||percentage of participants||95% Confidence Interval|Number
2686042|NCT01353586|Primary|The Incidence of Early Onset Primary Adverse Events|The primary safety endpoint is the incidence of early onset primary adverse events within 7 days of the mapping and ablation procedure. Primary adverse events include pericardial effusion requiring intervention, atrial perforation, pericarditis requiring intervention, cardiac tamponade, pneumothorax, death, pulmonary edema, diaphragmatic paralysis, heart block, stroke / cerebrovascular accident (CVA), hospitalization (initial and prolonged), thromboembolism, myocardial infarction (MI), transient ischemic attack (TIA), and vascular access complications. In addition, pulmonary vein stenosis and atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure are deemed primary adverse event.|Any of above events occurring within 7 days post-procedure (also including the incidence of pulmonary vein stenosis and atrio-esophageal fistula occurring > 7 days and up to one year post-procedure)|Safety Population as defined above|||percentage of participants||95% Confidence Interval|Number
2686043|NCT01353508|Secondary|Supine Pulse Rate|Pulse rate measurements were taken.|0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||BPM||Standard Deviation|Mean
2686044|NCT01353508|Secondary|Supine Diastolic Blood Pressure|Diastolic blood pressure measurements were taken.|0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||mmHg||Standard Deviation|Mean
2686045|NCT01353508|Secondary|Supine Systolic Blood Pressure|Systolic blood pressure measurements were taken.|0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 1; day 2; 0, 0.5, 1, 2, 4, 8 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||mmHg||Standard Deviation|Mean
2686046|NCT01353508|Secondary|Renal Blood Flow (RBF) Over Time|RBF was used as a measure of renal function.|0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||mL/min||Standard Deviation|Mean
2686047|NCT01353508|Secondary|Glomerular Filtration Rate (GFR) Over Time|GFR was used as a measure of renal function.|0, 2, 4 and 6 hours post dose on day 1; 0, 2, 4 and 6 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||mL/min||Standard Deviation|Mean
2686048|NCT01353508|Secondary|Percent Change From Baseline in Blood Plasma Creatinine|Blood plasma creatinine was analyzed at a central laboratory.|4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||Percentage change||95% Confidence Interval|Least Squares Mean
2686049|NCT01353508|Secondary|Percent Change From Baseline in Urinary Electrolyte Excretion (Sodium, Potassium, Chloride and Calcium)|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium, potassium, albumin and calcium were measured.|2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||Percentage change||95% Confidence Interval|Least Squares Mean
2686050|NCT01353508|Secondary|Percent Change From Baseline in Aldosterone Biomarker|Aldosterone was analyzed at a central laboratory.|6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||Percentage change||95% Confidence Interval|Least Squares Mean
2686051|NCT01353508|Secondary|Percent Change From Baseline in N-terminal-proBNP (NT-proBNP) Biomarker|NT-proBNP was analyzed at a central laboratory.|2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||Percentage change||95% Confidence Interval|Least Squares Mean
2686052|NCT01353508|Secondary|Percent Change From Baseline in C-terminal-proendothelin-1 (CT-proET-1) Biomarker|CT-proET-1 was analyzed at a central laboratory.|12 hours post dose on day 1; 24 hours post dose on day 2; 0 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||Percentage change||95% Confidence Interval|Least Squares Mean
2686053|NCT01353508|Secondary|Percent Change From Baseline in C-type Natriuretic Peptide (proCNP) Biomarker|ProCNP was analyzed at a central laboratory.|2, 4, 6, 8 and 12 hours post dose on day 1; day 2; 0, 4, 6, 8 and 12 hours post dose on day 7|The HF arms only of the Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. MR-proADM is considered a biomarker for HF only; therefore, the HTN cohort was not assessed.|||Percentage change||95% Confidence Interval|Least Squares Mean
2686054|NCT01353508|Secondary|Percent Change From Baseline in Mid-regional Pro-adrenomedullin (MR-proADM) Biomarker|MR-proADM was analyzed at a central laboratory.|2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The HF arms only of the Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis. MR-proADM is considered a biomarker for HF only; therefore, the HTN cohort was not assessed.|||Percentage change||95% Confidence Interval|Least Squares Mean
2686055|NCT01353508|Secondary|Percent Change From Baseline in Brain Natriuretic Peptide (BNP) Biomarker|BNP was analyzed at a central laboratory.|0.5, 1, 2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 0, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||Percentage change||95% Confidence Interval|Least Squares Mean
2686056|NCT01353508|Secondary|Percent Change From Baseline in Plasma Mid-regional Pro-atrial Natriuretic Peptide (MR-proANP) Biomarker|MR-proANP was analyzed at a central laboratory.|2, 4, 6 and 12 hours post dose on day 1; 24 hours post dose on day 2; 2, 4, 6 and 12 hours post dose on day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||Percentage change||95% Confidence Interval|Least Squares Mean
2686057|NCT01353508|Secondary|Urinary Cyclic Guanosine Monophosphate (cGMP) Excretion Over 24 Hours|cGMP was analyzed at a central laboratory. The measure type used for this OM was Geometric LSM.|day 1, day 6, day 7|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||nmol/24 hours||95% Confidence Interval|Least Squares Mean
2686058|NCT01353508|Secondary|7-day Cumulative Diuresis|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, urine volume was measured. The measure type used for this OM was Geometric LSM.|7-day cumulative (days 1 through 7)|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||mL||95% Confidence Interval|Least Squares Mean
2686059|NCT01353508|Secondary|24-hour Diuresis|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, urine volume was measured. The measure type used for this OM was Geometric LSM.|day 1|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||mL/24 hours||95% Confidence Interval|Least Squares Mean
2687891|NCT01337596|Secondary|Multiple Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax)||Day 43 up to Day 57|PK Population: All participants who received multiple doses LY2951742 study drug with interpretable PK data.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2686060|NCT01353508|Primary|Cumulative 7-day Urinary Sodium Excretion|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium concentration was measured. The measure type used for this outcome measure (OM) was Geometric Least square Means (LSM).|7 day-cummulative (days 1 through 7)|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||mmol/7 days||95% Confidence Interval|Least Squares Mean
2686061|NCT01353508|Primary|24-hour Urinary Sodium Excretion|Urine was collected in 12-hour intervals, and of each pooled 24-hour (daily) sample, sodium concentration was measured. The measure type used for this outcome measure (OM) was Geometric Least square Means (LSM).|day 1|The Pharmacodynamic (PD) analysis set, which included all participants who had no major protocol deviation with impact on PD data, were included in the analysis.|||mmol/24 hours||95% Confidence Interval|Least Squares Mean
2686062|NCT01353274|Secondary|Proportion of Patients Who Normalised Their BP|Proportion of patients who normalised their BP after 1, 2, 3, 6, 12 months|after 1, 2, 3, 6, 12 months|Efficacy set: all patients in the safety set who were labelled by T40/A5 mg FDC and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.|||Percentage of patients (normalised BP)|||Number
2686063|NCT01353274|Secondary|Proportion of Patients Who Achieved the Target BP|Proportion of patients who achieved the target BP after 1, 2, 3, 6, 12 months|after 1, 2, 3, 6, 12 months|Efficacy set: all patients in the safety set who were labelled by T40/A5 mg FDC and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.|||Percentage of patients (target BP)|||Number
2686064|NCT01353274|Secondary|Change From Baseline in Diastolic Blood Pressure (DBP)|Change from baseline in DBP after 1, 2, 3, 6, 12 months|after 1, 2, 3, 6, 12 months|Efficacy set: all patients in the safety set who were labelled by T40/A5 mg FDC and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.|||mmHg||Standard Deviation|Mean
2686065|NCT01353274|Secondary|Change From Baseline in Systolic Blood Pressure (SBP)|Change from baseline in SBP after 1, 2, 3, 6, 12 months|after 1, 2, 3, 6, 12 months|Efficacy set: all patients in the safety set who were labelled by T40/A5 mg Fixed Dose Combination (FDC) and have analysable BP data at baseline and at least one post-baseline time point. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.|||mmHg||Standard Deviation|Mean
2686066|NCT01353274|Primary|Incidence of Drug-related Adverse Events|Number of patients with drug-related adverse events|12 months|Safety set: all patients who were documented to have taken at least one dose of T40/A5 mg FDC except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact|||participants|||Number
2686067|NCT01353222|Primary|Overall Survival|"Overall survival is defined as the time from randomization to death due to any cause.~*This study was terminated early due to administrative reasons."|Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 60 months)|"Intent to Treat (ITT) population.~*This study was terminated early due to administrative reasons."|||Months||Full Range|Median
2686068|NCT01353196|Primary|Composite Cognitive Score|composite of multiple cognitive function test scores scores are reported as mean +/- standard deviation 0 = worst 100 = best|2 years|Participants that did not complete the study or missing key data elements were excluded from the overall analysis|||units on a scale||Standard Deviation|Mean
2686069|NCT01353144|Secondary|Number of Participants Deveoping Peptic Ulcer Bleeding|Number of participants deveoping peptic ulcer bleeding during 8-week study period|8 weeks||||participants|||Number
2686070|NCT01353144|Primary|Number of Participants in Whom Peptic Ulcer Was Healed|Number of participants in whom peptic ulcer was healed at week 8|8 weeks||||participants|||Number
2686071|NCT01353079|Secondary|Scores on a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Three Peak Weeks of Ragweed Pollen Season)|"Change from baseline in avg daily rhinoconjunctivitis symptom scores during the three peak weeks of ragweed pollen season for the ITT population (netpRSS).~Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS Total Score Range: 0 (min) - 48 (max); lower score was more favorable. Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for three peak weeks of ragweed pollen season."|3 peak weeks of the 2011 ragweed pollen season|ITT population includes subjects who had at least one post treatment efficacy measurement. This analysis includes subjects the met the ITT criteria excluding those subjects that did not have either a combined symptom/medication score or RSS during the three peak weeks of the ragweed pollen season.|||Scores on a scale||Standard Deviation|Least Squares Mean
2686072|NCT01353079|Secondary|Scores of a Scale (Average Daily Rhinoconjunctivitis Symptom Scores During the Entire Ragweed Pollen Season)|Change in baseline in avg daily RSS during entire ragweed season in ITT population. Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS Total Score Range: 0 (min) - 48 (max); lower score was more favorable. Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for entire ragweed season.|2011 ragweed pollen season; 8/2011 - 10/2011|ITT population includes subjects who had at least one post treatment efficacy measurement|||Scores on a scale||Standard Deviation|Least Squares Mean
2686083|NCT01352845|Secondary|Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1||Before first vaccination, 1 month after third vaccination (Vac)|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.|||Percentage of participants||95% Confidence Interval|Number
2686073|NCT01353079|Secondary|Scores on a Scale (Net Average Combined Daily Rhinoconjunctivitis Symptom and Medication Scores Reported During the Three Peak Weeks of Ragweed Pollen Season)|Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, watery eyes/tears), nasal (sneezing, itching, runny, stuffy nose), and ears (itching). Avg daily RSS computed by summing 8 individual allergy symptoms recorded in AM and PM; forming daily RSS by summing AM and PM RSS for each day; averaging daily RSS for three peak weeks. Total allergy relief medication score computed by summing individual medication scores. Relief medication scores: 0-no medication taken; 1-using once daily oral antihistamine; 1-using once daily ocular antihistamine; 1-treatment with albuterol. Max medication score dependent on cumulative rescue medication use. Lower result, more favorable. Three peak weeks of ragweed pollen counts during entire ragweed season was contiguous and calculated using a moving average of ragweed pollen counts for each week. Avg daily Combined Score Range: 0 (min) - 51 (max); lower score was more favorable.|3 peak weeks of the 2011 ragweed pollen season|ITT population includes subjects who had at least one post treatment efficacy measurement. This analysis includes subjects the met the ITT criteria excluding those subjects that did not have either a combined symptom/medication score or RSS during the three peak weeks of the ragweed pollen season.|||Scores on a scale||Standard Deviation|Least Squares Mean
2686074|NCT01353079|Primary|Scores on a Scale [Net Average Combined Daily Rhinoconjunctivitis Symptom (RSS) and Medication Scores]|Change in baseline in avg combined daily RSS and medication scores during entire ragweed season in ITT population. Symptom score: sum of scores from 8 symptoms rated 0-3 (0=absent, 1=mild, 2=moderate, 3=severe), ocular (itchiness, swelling/redness, and watery eyes/tears), nasal (sneezing, itching, runny and stuffy nose), and ears (itching). Avg daily RSS computed by: (1) summing 8 individual allergy symptoms recorded in AM and PM; (2) forming daily RSS by summing AM and PM RSS for each day of ragweed season; (3) averaging daily RSS for entire ragweed season.Total allergy relief medication score computed by summing individual medication scores. Relief medication scores: 0-no medication taken; 1-using once daily oral antihistamine; 1-using once daily ocular antihistamine; 1-treatment with albuterol. Maximum medication score dependent on cumulative rescue medication use. Lower result is more favorable. Avg daily Combined Score Range: 0 (min) - 51 (max); lower score was more favorable.|2011 ragweed pollen season, 8/2011 -10/2011|ITT population includes subjects who had at least one post treatment efficacy measurement|||Scores on a scale||Standard Deviation|Least Squares Mean
2686075|NCT01352845|Secondary|Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1||One month after third bivalent rLP2086 vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.|||Percentage of participants||95% Confidence Interval|Number
2686076|NCT01352845|Secondary|Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination||One month after third bivalent rLP2086 vaccination|Data was not reported because 3-fold rise analyses was not performed as per change in planned analysis.||||||
2686077|NCT01352845|Secondary|hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1||Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.|||Titer||95% Confidence Interval|Geometric Mean
2686078|NCT01352845|Secondary|Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1|Results for PMB80[A22] 1:16, PMB2001[A56] 1:8, PMB2948[B24] 1:8 and PMB2707[B44] 1:8 are reported under secondary endpoint 'Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1'.|Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.|||Percentage of participants||95% Confidence Interval|Number
2686079|NCT01352845|Secondary|Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1||Before Vaccination (Vac) 1, 1 Month after Vac 2, 3|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.|||Percentage of participants||95% Confidence Interval|Number
2686080|NCT01352845|Secondary|Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination: Group 1||One month after second Bivalent rLP2086 vaccination|Evaluable immunogenicity population. Here, N signifies participants with valid and determinate hSBA titers for the given strain at both the specified time point. This outcome measure was planned to be analyzed for Group 1 only.|||Percentage of participants||95% Confidence Interval|Number
2686081|NCT01352845|Secondary|Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination: Group 1||Before vaccination 1, 1 Month after Vaccination 2|Evaluable immunogenicity population. Here, N signifies participants valid and determinate hSBA results on all 4 strains at the given time point. This outcome measure was planned to be analyzed for Group 1 only.|||Percentage of participants||95% Confidence Interval|Number
2686082|NCT01352845|Secondary|hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1||Before first vaccination, 1 month after third vaccination|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate assay results for the given antigen or strain. This outcome measure was planned to be analyzed for Group 1 only.|||Titers||95% Confidence Interval|Geometric Mean
2703733|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|6 weeks|||||||
2686084|NCT01352845|Secondary|Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1||Before first vaccination, 1 month after third vaccination|Evaluable immunogenicity population. Here, number of participants analyzed signifies participants with valid and determinate hSBA titers for the given strain. Here, N signifies participants with valid and determinate hSBA titers for the given strain at the specified time point. This outcome measure was planned to be analyzed for Group 1 only.|||Percentage of participants||95% Confidence Interval|Number
2686085|NCT01352845|Primary|Number of Days Participants Missed School or Work Due to AE During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available. Here, number of participants analyzed signifies subjects that were evaluable for this outcome measure.|||Days||Standard Deviation|Mean
2686086|NCT01352845|Primary|Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination||Within 30 minutes after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||Percentage of participants||95% Confidence Interval|Number
2686087|NCT01352845|Primary|Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination||Within 30 minutes after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||Percentage of participants||95% Confidence Interval|Number
2686088|NCT01352845|Primary|Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination||Within 30 minutes after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.|||Percentage of participants||95% Confidence Interval|Number
2686089|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
2686090|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or saline) for whom safety information was available from after post third-vaccination blood draw to 6 months after last study vaccination.|||Percentage of participants||95% Confidence Interval|Number
2686091|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
2686092|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
2686093|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||Percentage of participants||95% Confidence Interval|Number
2686094|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||Percentage of participants||95% Confidence Interval|Number
2686095|NCT01352845|Primary|Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.|||Percentage of participants||95% Confidence Interval|Number
2686096|NCT01352845|Primary|Percentage of Participants Reporting at Least 1 Medically Attended Adverse Event Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
2686097|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or saline) for whom safety information was available from after post-vaccination 3 blood draw to 6 months after last study vaccination.|||Percentage of participants||95% Confidence Interval|Number
2686098|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
2688121|NCT01335932|Secondary|Bacteremia and Fungemia Outcomes in Mechanically Ventilated Subjets|Bacteremia and fungemia events among subjects who are mechanically ventilated for at least 7 through 14 days after randomization|at 7 through 14 days post-randomization||||events|||Number
2686099|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
2686100|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until until post third-vaccination blood draw.|||Percentage of participants||95% Confidence Interval|Number
2686101|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||Percentage of participants||95% Confidence Interval|Number
2686102|NCT01352845|Primary|Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.|||Percentage of participants||95% Confidence Interval|Number
2686103|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period||From the first vaccination up to 6 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
2686104|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
2686105|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-up Phase||From 1 month after third vaccination up to 6 months after the third vaccination|Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or saline) for whom safety information was available from after post-vaccination 3 blood draw to 6 months after last study vaccination.|||Percentage of participants||95% Confidence Interval|Number
2686106|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
2686107|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||Percentage of participants||95% Confidence Interval|Number
2686108|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||Percentage of participants||95% Confidence Interval|Number
2686109|NCT01352845|Primary|Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.|||Percentage of participants||95% Confidence Interval|Number
2686110|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase||From the first vaccination up to 1 month after the third vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
2686111|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination||Within 30 days after any vaccination|Safety population included all the participants who received at least 1 dose of the investigational product (rLP2086 or saline) and had safety data available.|||Percentage of participants||95% Confidence Interval|Number
2686112|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination||Within 30 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||Percentage of participants||95% Confidence Interval|Number
2686113|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination||Within 30 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||Percentage of participants||95% Confidence Interval|Number
2686114|NCT01352845|Primary|Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After First Vaccination||Within 30 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.|||Percentage of participants||95% Confidence Interval|Number
2688122|NCT01335932|Secondary|Bacteremia and Fungemia Outcomes|Bacteremia and fungemia outcomes among subjects who survive at least 7 days|at 7 days post-randomization||||events|||Number
2686115|NCT01352845|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination||Within 7 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw. Here, 'N' signifies participants with known values reporting specific characteristic.|||Percentage of participants||95% Confidence Interval|Number
2686116|NCT01352845|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination||Within 7 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination. Here, 'N' signifies participants with known values reporting specific characteristic.|||Percentage of participants||95% Confidence Interval|Number
2686117|NCT01352845|Primary|Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination||Within 7 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination. Here, 'N' signifies participants with known values reporting specific characteristic.|||Percentage of participants||95% Confidence Interval|Number
2686118|NCT01352845|Primary|Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination||Within 7 days after third vaccination|Safety population for third vaccination included all participants who received the third dose of investigational product (rLP2086 or saline) and for whom safety information was available from third vaccination until post third-vaccination blood draw.|||Percentage of participants||95% Confidence Interval|Number
2686119|NCT01352845|Primary|Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination||Within 7 days after second vaccination|Safety population for second vaccination included all participants who received the second dose of investigational product (rLP2086 or saline) and for whom safety information was available from second vaccination until prior to third vaccination.|||Percentage of participants||95% Confidence Interval|Number
2686120|NCT01352845|Primary|Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination||Within 7 days after first vaccination|Safety population for first vaccination included all participants who received the first dose of investigational product (rLP2086 or saline) and for whom safety information was available from first vaccination until prior to second vaccination.|||Percentage of participants||95% Confidence Interval|Number
2686121|NCT01352845|Primary|Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1|Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point. This outcome measure was planned to be analyzed for Group 1 only.|One month after third bivalent rLP2086 vaccination|Evaluable immunogenicity population: all eligible participants randomized, who received correct investigational product, had pre/post vaccination blood drawn at pre-specified time points, had valid and determinate assay results for proposed analysis, received no prohibited treatment or prohibited vaccines, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
2686122|NCT01352793|Secondary|Number of Days Participant Missed School or Work Due to Adverse Events (AEs)||Vaccination 1 up to 1 month after Vaccination 3|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.|||days||Full Range|Median
2686123|NCT01352793|Secondary|Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination|An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|Within 30 minutes after Vaccination 1, 2, 3|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.|||percentage of participants||95% Confidence Interval|Number
2686124|NCT01352793|Secondary|Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods|An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3)|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.|||percentage of participants||95% Confidence Interval|Number
2686125|NCT01352793|Secondary|Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods|A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3)|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.|||percentage of participants||95% Confidence Interval|Number
2686138|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Overall Quality of Sleep|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.|||participants|||Number
2686126|NCT01352793|Secondary|Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods|A medically attended AE was defined as a non-serious AE that required medical attention.|Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3)|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.|||percentage of participants||95% Confidence Interval|Number
2686127|NCT01352793|Secondary|Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods|An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.|Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3)|Safety population included all participants who received at least 1 dose of the study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.|||percentage of participants||95% Confidence Interval|Number
2686128|NCT01352793|Primary|Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3|A medically attended AE was defined as a non-serious AE that required medical attention.|Within 30 days after Vaccination 3|Vaccination 3 safety population included all participants who received the third dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available from Vaccination 3 to post Vaccination 3 follow-up visit (1 month after Vaccination 3).|||percentage of participants||95% Confidence Interval|Number
2686129|NCT01352793|Primary|Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2|A medically attended AE was defined as a non-serious AE that required medical attention.|Within 30 days after Vaccination 2|Vaccination 2 safety population included all participants who received the second dose of study vaccine (bivalent rLP2086 or saline) and had safety information available from Vaccination 2 until prior to Vaccination 3.|||percentage of participants||95% Confidence Interval|Number
2686130|NCT01352793|Primary|Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1|A medically attended AE was defined as a non-serious AE that required medical attention.|Within 30 days after Vaccination 1|Vaccination 1 safety population included all participants who received the first dose of study vaccine (bivalent rLP2086 or HAV vaccine) and had safety information available from Vaccination 1 until prior to Vaccination 2.|||percentage of participants||95% Confidence Interval|Number
2686131|NCT01352793|Primary|Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study|An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.|Vaccination 1 up to 6 months after Vaccination 3|Safety population included all participants who received at least 1 dose of study vaccine (bivalent rLP2086 or HAV vaccine or saline) and had safety information available.|||percentage of participants||95% Confidence Interval|Number
2686132|NCT01352741|Secondary|Double-blind Comparative Period: Subject's Satisfaction With Treatment|"Participants rated their satisfaction with the study drug (IMPs) by answering the following question on a 5-point rating scale:~How would you rate your overall satisfaction with your current pain treatment?: Excellent, Very Good, Good, Fair and Poor."|End of Comparative Period at Final Evaluation Visit (Day 77)|Last Observation Carried Forward (LOCF); Per Protocol Set|||participants|||Number
2686133|NCT01352741|Secondary|Open-label Titration Period: Subject's Satisfaction With Treatment|"Participants rated their satisfaction with the study drug (IMPs) by answering the following question on a 5-point rating scale:~How would you rate your overall satisfaction with your current pain treatment?: Excellent, Very Good, Good, Fair and Poor."|End of Open-label Titration Period at Randomization Visit (Day 22)|Last Observation Carried Forward (LOCF); Per Protocol Set|||participants|||Number
2686134|NCT01352741|Secondary|Double-blind Comparative Period: Change in the Overall Quality of Sleep|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The improvement, no change or worsening is reported based on the replies scored by the participants given at their End of Continuation Visit."|Randomization Visit (Day 22) to Final Evaluation (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||participants|||Number
2686135|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Overall Quality of Sleep in the Double-blind Comparative Period Population|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor."|Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||participants|||Number
2686136|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Overall Quality of Sleep in the Double-blind Comparative Period Population|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor."|Baseline Visit (Day 1)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||participants|||Number
2686137|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Overall Quality of Sleep in the Double-blind Comparative Period Population|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor."|Enrollment Visit (Day-12)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||participants|||Number
2686139|NCT01352741|Secondary|Double-blind Comparative Period: Sleep Evaluation Questionnaire - Change in the Number of Hours Slept|The sleep evaluation questionnaire was completed by the participant. The answer was in response to the question: Sleep evaluation: How long did you sleep last night [hours]? The value reported is the change in the number of hours of sleep from baseline. The positive value indicates that there was an increase in the number of hours of sleep in a treatment group.|Baseline Visit (Day -12); Randomization Visit (Day 1); Final Evaluation Visit (Day 77)|Per Protocol Set.|||hours||Standard Deviation|Mean
2686140|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Number of Hours Slept in the Double-blind Comparative Period Population|"The participants were requested to answer the following question:~How long did you sleep last night [hours]? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline) and for the night prior to the End of the Continuation Visit (12 weeks after randomization)."|Enrollment Visit (Day -12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Per Protocol Set (PPS).|||hours||Standard Deviation|Mean
2686141|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Time Slept|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.~The participant was asked: How long did you sleep last night? [Answered in hours and minutes]."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.|||hours||Standard Deviation|Mean
2686142|NCT01352741|Secondary|Double-blind Comparative Period: Change in the Number of Awakenings|The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings. Participants were asked: How many times did you wake up during the night? The change in the Number of Awakenings was calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Final Evaluation Visit (Day 77). A negative change indicates that the number of awakenings in a treatment group have gone down since the Baseline or Randomization Visit. In general pain can interfere with sleep, one potential indicator is the number of awakenings.|Baseline Visit (Day 1); Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)|Per Protocol Set (PPS).|||Number of Awakenings||Standard Deviation|Mean
2686143|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation - Number of Awakenings in the Double-blind Comparative Period Population|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.~How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Randomization Visit (Day 22).~The participant was asked at each visit: How many times did you wake up during the night?"|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||Number of Awakenings||Standard Deviation|Mean
2686144|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Number of Awakenings|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.~How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Randomization Visit (Day 22).~The participant was asked at each visit: How many times did you wake up during the night?"|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.|||Number of Awakenings||Standard Deviation|Mean
2686145|NCT01352741|Secondary|Double-blind Comparative Period Sleep Evaluation Questionnaire: Change in Latency|The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the visits. The negative change from baseline indicates that the time to falling asleep decreased from baseline in a treatment group.|Baseline Visit (Day 1); Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)|Per Protocol Set (PPS).|||hours||Standard Deviation|Mean
2686146|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Latency in the Double-blind Comparative Period Population|The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the Randomization Visit (Baseline) and for the night prior to the Final Evaluation Visit (12 weeks after randomization). The higher the value the longer it took to fall asleep. Sleep evaluation questionnaire (SQ) items|Enrollment Visit (Day -12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Per Protocol Set (PPS).|||hours||Standard Deviation|Mean
2686147|NCT01352741|Secondary|Open-label Titration Period: Sleep Evaluation Questionnaire - Latency|"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the sleep latency.~To assess latency the participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]?"|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.|||hours||Standard Deviation|Mean
2686148|NCT01352741|Secondary|Double-blind Comparative Period: Change in Hospital Anxiety and Depression Scale - Depression in the Double-blind Comparative Period Population|The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement. A negative change value indicates a decrease in the depression score since the start of treatment.|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
2686190|NCT01352585|Secondary|Red Blood Cell (RBC) Count||1 year|The Safety Set consisted of all subjects enrolled in the study who took at least 1 dose of anagrelide hydrochloride.|||RBC Count (x10^12/L)||Standard Deviation|Mean
2686191|NCT01352585|Secondary|Platelet Count||1 year|FAS|||Platelets (x10^9/L)||Standard Deviation|Mean
2686149|NCT01352741|Secondary|Open-label Titration Period: Hospital Anxiety and Depression Scale - Depression in the Double-blind Comparative Period Population|The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement.|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-blind Comparative Population; Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
2686150|NCT01352741|Secondary|Double-blind Comparative Period: Change in Hospital Anxiety and Depression Scale - Anxiety in the Double-blind Comparative Period Population|"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.~A negative sign indicates that there has been a decrease in anxiety since the start of treatment."|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
2686151|NCT01352741|Secondary|Open-label Titration Period: Hospital Anxiety and Depression Scale - Anxiety in the Double-blind Comparative Period Population|"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.~A decrease in values over the trial period indicate that there has been an improvement."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
2686152|NCT01352741|Secondary|Double-blind Comparative Period: Clinician Global Impression of Change (CGIC)|"In the Clinician Global Impression of Change (CGIC) the clinician indicated the perceived change over the treatment period. The clinician was requested to choose one of seven categories for each participant. The Clinician rated the participants change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Full Analysis Set (FAS).|||participants|||Number
2686153|NCT01352741|Secondary|Double-blind Comparative Period: Patient Global Impression of Change (PGIC)|"In the Patient Global Impression of Change (PGIC) the participant indicated the perceived change over the treatment period. PGIC is a 7 point scale where the patient's rates overall improvement. Patients rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse."|Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)|Double-blind comparative population. Full Analysis Set (FAS).|||participants|||Number
2686154|NCT01352741|Secondary|Double-blind Comparative Period: Change EuroQol-5 Dimension (EQ-5D) Health Status Index|"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
2686155|NCT01352741|Secondary|Open-label Titration Period: EuroQol-5 Dimension (EQ-5D) Health Status Index Score for the Double-blind Comparative Period Population|"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group."|Enrollment Visit (day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
2686156|NCT01352741|Secondary|Double-blind Comparative Period: Change in Short Form Health Survey (SF-12) Mental Health Composite Score (MCS)|The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The mental health summary scores were calculated from the individual responses to two of the 12 questions. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible mental health.|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
2686157|NCT01352741|Secondary|Open-label Titration Period: Comparative Double-blind Period Population Short Form Health Survey (SF-12) Mental Health Composite Score (MCS)|The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The mental health summary scores were calculated from the individual responses to two of the 12 questions. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible mental health.|Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
2703734|NCT01216631|Secondary|US Synovitis Score|Change in US synovitis score of the affected knee at 2 and 8 weeks after treatment initiation|16 weeks|||||||
2686158|NCT01352741|Secondary|Double-blind Comparative Period: Changes in the Short Form Health Survey (SF-12) Physical Health Composite Score (PCS)|"The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical summary scores were calculated from the individual responses to those questions covering physical health. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.~The change in the SF-12 score shows an improvement in health from baseline if the values are positive. The higher the value the greater the improvement."|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
2686159|NCT01352741|Secondary|Open-label Titration Period: Comparative Double-blind Period Population Short Form Health Survey (SF-12) Physical Health Composite Score (PCS)|The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical and mental summary scores were calculated from the individual responses. A higher score indicates a better perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.|Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
2686160|NCT01352741|Secondary|Double-blind Comparative Period: Change in Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale, from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. Spontaneous Pressing Pain Subscore). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) subscores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 10 (100 for the overall score) . A negative change indicates that the intensity of the symptom has decreased since the start of treatment.|Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
2686161|NCT01352741|Secondary|Open-label Titration Period: Neuropathic Pain Symptom Inventory (NPSI) Overall Score Assessment in the Double-blind Comparative Period Population|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 100.|Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
2686162|NCT01352741|Secondary|Open-label Titration Period: Neuropathic Pain Symptom Inventory (NPSI) Overall Score Assessment|In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 100.|Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.|||units on a scale||Standard Deviation|Mean
2686163|NCT01352741|Secondary|Double-blind Comparative Period: Change in painDETECT Final Assessment|"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear. The theoretical range of change in this trial ranged from -38 to 19. A negative change indicated a decrease in their neuropathic component of pain."|Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
2686164|NCT01352741|Secondary|Open-label Titration Period: Comparative Double-blind Period Population painDETECT Assessment|"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-blind comparative population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
2686192|NCT01352585|Secondary|Number of Patients With Platelet Count ≤400x10^9/L After 12 Months|A platelet count of ≤400x10^9/L after 12 months is considered a complete response.|1 year|FAS|||participants|||Number
2703735|NCT01216631|Secondary|Rheumatoid Arthritis Outcome Score (RAOS)|Change in RAOS questionnaire score|2 weeks|||||||
2686165|NCT01352741|Secondary|Open-label Titration Period: painDETECT Assessments|"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear."|Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.|||units on a scale||Standard Deviation|Mean
2686166|NCT01352741|Secondary|Double-blind Comparative Period: Change in Worst Pain Intensity Over the Past 24 Hours|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked: Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit.~A negative change indicates that the pain intensity decreased from the start of the trial."|Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
2686167|NCT01352741|Secondary|Open-label Titration Period: Comparative Double-blind Period Population Worst Mean Pain Intensity Scores Over the Past 24 Hours|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric Rating Scale (NRS), where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked : Please rate your pain intensity by assessing the one number that best describes your worst pain during the past 24 hours prior to the visit."|Enrollment Visit (Day-12); Baseline Visit (day 1); Randomization Visit (Day 22)|Double-blind comparative population. Per Protocol Set (PPS)|||units on a scale||Standard Deviation|Mean
2686168|NCT01352741|Secondary|Open-label Titration Period: Worst Mean Pain Intensity Scores Over the Past 24 Hours|"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked: Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit."|Enrollment Visit (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.|||units on a scale||Standard Deviation|Mean
2686169|NCT01352741|Secondary|Double-blind Comparative Period: Change in NRS-3 Pain Intensity Score for the Radiating Pain|"NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on 11-point NRS, where 0 is the no pain and 10 is pain as bad as you can imagine) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot).~The value reported represents the change from the randomization visit (i.e., the last 3 days in the titration period) to the end of the double-blind comparative period (i.e., the last 3 days in the comparative period). The theoretical values range from -10 to 10. A negative sign indicates a decrease in pain from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (baseline visit)."|Randomization Visit (Day 22); End of Evaluation Visit (Day 77)|Double-blind comparative population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
2686170|NCT01352741|Secondary|Open-label Titration Period: Radiating Mean Pain Intensity Score for the Comparative Period Population|The NRS-3 pain intensity score at the visits in the open-label titration period for the two comparative double-blind period treatment groups analyzed is reported. NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on an 11-point NRS) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot) is reported. Where 0 = no pain and 10 indicates pain as bad as you can imagine.|Enrollment Visit (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
2686171|NCT01352741|Secondary|Open-label Titration Period: Radiating Pain|The NRS-3 pain intensity score at the visits in the open-label titration period for the two comparative double-blind period treatment groups analyzed is reported. NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on an 11-point NRS) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot) is reported. Where 0 = no pain and 10 indicates pain as bad as you can imagine.|Enrollment Visit (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed.|||units on a scale||Standard Deviation|Mean
2686172|NCT01352741|Secondary|End of Open-label Pick-up Period: Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)|"The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit). Where 0 = no pain and 10 indicates pain as bad as you can imagine."|Final Evaluation Visit (Day 77)|Observed.|||units on a scale||Standard Deviation|Mean
2686173|NCT01352741|Secondary|Open-label Continuation Period: Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)|"The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit). Where 0 = no pain and 10 indicates pain as bad as you can imagine."|Enrollment (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)|Observed values.|||units on a scale||Standard Deviation|Mean
2686174|NCT01352741|Secondary|Open-label Titration Period: Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)|"The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit). Where 0 = no pain and 10 indicates pain as bad as you can imagine. This is the treatment period prior to the primary outcome period."|Enrollment (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)|Observed values.|||units on a scale||Standard Deviation|Mean
2686175|NCT01352741|Primary|Change in the Average Pain Intensity Score for the Overall Low Back Pain on an 11-point Numeric Rating Scale (NRS-3)|"The primary endpoint is defined as the comparison of tapentadol prolonged release (PR) 300 mg plus 200 mg per day and the combination of tapentadol PR 300 mg per day and pregabalin 300 mg per day regarding the change in NRS-3 pain intensity scores (recalled average pain intensity score during the last 3 days on 11-point NRS, where 0 is the no pain and 10 is pain as bad as you can imagine) from the randomization visit to the final evaluation visit.~Theoretically a maximum decrease of -10 and an increase of +4 in the pain intensity would have been possible. A negative sign indicates a decrease in pain intensity from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (Baseline visit)."|Randomization (Day 22); Final Evaluation Visit (Day 77)|Double-Blind Comparative Population. Per Protocol Set (PPS).|||units on a scale||Standard Deviation|Mean
2686176|NCT01352715|Secondary|Changes in Fasting Total Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, Triglycerides, and Glucose From Baseline|Fasting was for 8 hours and the metabolic panel was drawn locally.|Study entry and week 48|Intention to treat: All 512 participants without a major eligibility violation with data available at entry and week 48 were included in their assigned randomized treatment arm. total cholesterol (Arm A N=216 B N=220) HDL (Arm A N=219 B N=223) LDL (Arm A N=202 B N=205) triglycerides (Arm A N=219 B N=222), glucose (Arm A N=213 B N=223)|||mg/dL||95% Confidence Interval|Mean
2686177|NCT01352715|Secondary|Percentage of Time Spent in Hospital|The percentage of total study time that participants were in hospital.|From study entry throughout follow-up (up to 96 weeks)|Intention to treat: All 512 participants without a major eligibility violation were in the analysis: participants were analyzed per original assigned randomized treatment.|||percentage of time spent in hospital|||Number
2686178|NCT01352715|Secondary|Number of Participants With a Targeted Serious Non-AIDS-defining Event or Death|Serious non-AIDS diagnoses were based on ACTG Appendix 60 Diagnosis Codes|From study entry throughout follow-up (up to 96 weeks)|Intention to treat: All 512 participants without major eligibility violations were in the analysis: participants were analyzed per original assigned randomized treatment.|||participants|||Number
2686179|NCT01352715|Secondary|Number of Participants With a New AIDS-defining Events or Death|AIDS-defining events were those recognized by the Centers for Disease Control (CDC) and World Health Organization (WHO)|From study entry throughout follow-up (up to 96 weeks)|Intention to treat: All 512 participants without major eligibility violations were in the analysis: participants were analyzed per original assigned randomized treatment.|||participants|||Number
2686180|NCT01352715|Secondary|Number of Participants Discontinuing Randomized Treatment for Toxicity|Discontinuation of randomized treatment for toxicity included participant decision to discontinue for low grade toxicity. Within class NRTI changes were not considered discontinuations.|From Start of Randomized Treatment to Off Randomized Treatment (up to 96 weeks)|Competing risk approach: Time was measured from start of randomized treatment until the date of randomized treatment discontinuation for toxicity. Randomized treatment discontinuation for other reasons was considered as an independent competing risk, and participants discontinuing the study were censored on the date of last participant contact.|||participants|||Number
2686181|NCT01352715|Secondary|Number of Participants With Grade 3 or Higher Adverse Event (AE) at Least One Grade Higher Than Baseline|The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs.|From start of randomized treatment to off randomized treatment (up to 96 weeks)|As treated: Participants on randomized treatment are included in this analysis.|||participants|||Number
2686182|NCT01352715|Secondary|Number of Participants With HIV-1 Drug Resistance Mutations in Protease, Reverse Transcriptase, and Integrase in Participants With Virologic Failure at Baseline and at Time of Virologic Failure|Mutations were defined as major IAS mutations in the IAS-USA July 2014 list. New mutations were those detected at virologic failure but not at baseline.|From study entry through to week 96|Participants with virologic failure, and with a pair of baseline and virologic failure sequences available, were included in the analysis.|||participants|||Number
2686183|NCT01352715|Secondary|Change in CD4+ Cell Count From Baseline to Week 48|Change in CD4+ cell count was calculated as CD4+ cell count at week 48 minus CD4+ cell count at study entry.|Study entry and week 48|Intention to treat: All 488 participants without a major eligibility violation, and with baseline and week 48 data available were used in the analysis: participants were analyzed per original assigned randomized treatment.|||cells/mm^3||95% Confidence Interval|Mean
2686184|NCT01352715|Primary|Cumulative Probability of Virologic Failure by Week 48|The primary endpoint was time to virologic failure. Virologic failure was defined as confirmed viral load >400 copies/mL at or after week 24. The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 48 was used.|From study entry to week 48|Intention to treat: All 512 participants without a major eligibility violation were included in the analysis: participants were analyzed per original assigned randomized treatment.|||cumulative probability per 100 persons||95% Confidence Interval|Number
2686185|NCT01352637|Primary|CAPS-IV at the End of Treatment|"Clinician Administered PTSD Scale (CAPS) for the DSM-IV [34]. The CAPS-IV is a structured clinical interview designed to assess the 17 DSM-IV PTSD symptoms. CAPS-IV provides categorical ratings of diagnostic status as well as a quantitative index of symptom severity. The CAPS total severity score is based on response to the 17 items that assess the frequency and intensity of current PTSD symptoms. Symptom severity is assessed separately for past month and past week time frames.~CAPS-IV range is 0-136, higher scores mean a worse outcome."|after weekly treatment session 9 (at posttreatment assessment)|"Total sample size is n=192. Randomization allocation ratio was 1:1:1:1 to VRE vs. PE and DCS vs. placebo.~Study had 2 co-primary aims to examine:~the effects of DCS (n=95) vs placebo (n=97) augmentation of exposure therapy~the relative efficacy of VRE (n=97) and PE (n=95) on PTSD symptoms."|||units on a scale||Standard Deviation|Mean
2686186|NCT01352585|Secondary|Hematocrit Level||1 year|Safety Set|||Hematocrit (fraction of 1)||Standard Deviation|Mean
2686187|NCT01352585|Secondary|Hemoglobin Concentration||1 year|Safety set|||g/L||Standard Deviation|Mean
2686188|NCT01352585|Secondary|Differential WBC Count||1 year|Safety Set|||percent||Standard Deviation|Mean
2686189|NCT01352585|Secondary|White Blood Cell (WBC) Count||1 year|Safety Set|||WBC Count (x10^9/L)||Standard Deviation|Mean
2703736|NCT01216631|Secondary|Psoriatic Arthritis Quality of Life Scale (PsQOL)|Change in PsQOL score from baseline|2 weeks|||||||
2686193|NCT01352585|Primary|Number of Patients With Platelet Count ≤600x10^9/L After 12 Months|A platelet count of ≤600x10^9/L after 12 months is considered at least a partial response.|1 year|The Full Analysis Set (FAS) consisted of all subjects in the Safety Set who had at least 1 post-baseline platelet count and their JAK2 mutation status was assessed. 35 patients in the FAS had a viable platelet sample.|||participants|||Number
2686194|NCT01352546|Primary|Ability to Achieve Pain Free Intercourse.|Patients need to be able to transition from the use of vaginal dilators to pain free intercourse, or to be able to continue using the #5 or #6 of 6 dilators in the absence of a partner.|one year||||percentage of participants|||Number
2686195|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Erectile Function Domain|Self-reported erectile function over the past 4 weeks. IIEF erectile function was the sum of Q1 through Q5 and Q15 of the IIEF. Q1 through Q5 were scored 0 (low/no erectile function) to 5 (high erectile function) and Q15 was scored 1 (no/low confidence) to 5 (high confidence). IIEF erectile function domain scores ranged from 1 to 30. Change was defined as endpoint minus baseline domain score. Change in IIEF erectile function domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF EF domain score. Higher scores were indicative of better erectile function.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 IIEF post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2686196|NCT01352507|Secondary|Change in PAIRS Time Concerns Domain|PAIRS was a self-administered, 29-item scale that assessed the broader psychological and interpersonal outcomes associated with ED and its treatment. Each question was rated on a Likert scale that ranged from 1 (strongly disagree) to 4 (strongly agree). The time concerns domain score was the average score for Items 1, 2, 6, 7, 8, 20, 24, and 25. Time concern domain scores ranged from 1 (strongly disagree) to 4 (strongly agree). Change was defined as endpoint minus baseline domain score. Change in PAIRS time concerns at Week 8 and Week 18 were averaged to produce an overall change in PAIRS time concerns domain score. Higher scores were indicative of more time concerns.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 PAIRS post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2686197|NCT01352507|Secondary|Change in PAIRS Spontaneity Domain|PAIRS was a self-administered, 29-item scale that assessed the broader psychological and interpersonal outcomes associated with ED and its treatment. Each question was rated on a Likert scale that ranged from 1 (strongly disagree) to 4 (strongly agree). The spontaneity domain score was the average score for Items 3, 12, 13, 16, 17, 19, 21, 22, and 28. Spontaneity domain scores ranged from 1 (strongly disagree) to 4 (strongly agree). Change was defined as endpoint minus baseline domain score. Change in PAIRS spontaneity domain at Week 8 and Week 18 were averaged to produce an overall change in PAIRS spontaneity domain score. Higher scores were indicative of greater spontaneity.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 PAIRS post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2686198|NCT01352507|Secondary|Change in Sexual Encounter Profile (SEP) Question 3|"Participant-assessed diary that assessed the mean change from baseline in the percentage of yes responses to SEP Q3, Did your erection last long enough for you to have successful intercourse?. The SEP Q3 score was determined as the percentage of yes responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus percentage of yes responses at baseline. Change in the percentage of yes responses to SEP Q3 at Week 8 and Week 18 were averaged to produce an overall change in SEP Q3."|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 SEP post-baseline measurement.|||"percentage of yes responses"||Standard Deviation|Mean
2686199|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Orgasmic Function Domain|Self-reported orgasmic function over the past 4 weeks. IIEF orgasmic function was the sum of Q9 and Q10 of the IIEF. Scores ranged from 0 (no stimulation) to 5 (almost always) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF orgasmic function domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF orgasmic function domain score. Higher scores were indicative of better orgasmic function.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 IIEF post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2686200|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Sexual Desire Domain|Self-reported sexual desire over the past 4 weeks. IIEF sexual desire was the sum of Q11 and Q12. Scores ranged from 1 (low/almost never) to 5 (very high/almost always) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF sexual desire domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF sexual desire domain score. Higher scores were indicative of increased sexual desire.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 IIEF post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2686201|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain|Self-reported intercourse satisfaction over the past 4 weeks. IIEF intercourse satisfaction was the sum of Q6, Q7, and Q8 of the IIEF. Scores ranged from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions ranging from 0 to 15. Change was defined as endpoint minus baseline domain score. Change in IIEF intercourse satisfaction domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF intercourse satisfaction domain score. Higher scores were indicative of an increase in intercourse satisfaction.|Baseline, Week 8, and Week 18|All randomized participants with baseline and at least 1 IIEF post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2686202|NCT01352507|Secondary|Drug Attributes Questionnaire (DRAQ) at Week 18|DRAQ was a questionnaire used to record explanations for why participants preferred a drug. Participants identified their first and second reasons for drug preference from a choice of 7 reasons. Each reason for drug preference includes participants who selected that reason as their first or second reason.|Week 18|Randomized participants who completed both treatment periods (Week 18), responded to the DRAQ, and were analyzed according to their assigned treatment.|||percentage of participants|||Number
2686218|NCT01352286|Secondary|Best Objective Response (BOR)|Number of participants with Best Objective Response of sCR, CR, VGPR, or PR|Best Objective Response prior to initiation of lenalidomide and at Year 1|Participants who received NYESO-1ᶜ²⁵⁹T following ASCT with Best Objective Response (BOR) data.|||Participants|||Count of Participants
2686203|NCT01352507|Secondary|Change in Psychosocial and Interpersonal Relationship Scale (PAIRS) Sexual Self-Confidence Domain|PAIRS was a self-administered, 29-item scale that assessed the broader psychological and interpersonal outcomes associated with ED and its treatment. Each question was rated on a Likert scale that ranged from 1 (strongly disagree) to 4 (strongly agree). The sexual self-confidence domain score was the average score for Items 5, 10, 15, 23, 27, and 29. Sexual self-confidence domain scores ranged from 1 (strongly disagree) to 4 (strongly agree). Change was defined as endpoint minus baseline domain score. Change in PAIRS sexual self-confidence domain scores at Week 8 and Week 18 were averaged to produce an overall change in PAIRS sexual self-confidence domain score. Higher scores were indicative of greater sexual self-confidence.|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 PAIRS post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2686204|NCT01352507|Secondary|Change in Sexual Encounter Profile (SEP) Question 2|"Participant-assessed diary that assessed the mean change from baseline in the percentage of yes responses to SEP Q2, Were you able to insert your penis into your partner's vagina?. The SEP Q2 score was determined as the percentage of yes responses to SEP Q2 out of all sexual attempts recorded during the time period. Change was defined as the percentage of yes responses at endpoint minus the percentage of yes responses at baseline. Change in percentage of yes responses to SEP Q2 at Week 8 and Week 18 were averaged to produce an overall change in SEP Q2."|Baseline, Week 8, and Week 18|Randomized participants with baseline and at least 1 post-baseline SEP measurement.|||"percentage of yes responses"||Standard Deviation|Mean
2686205|NCT01352507|Secondary|Change in International Index of Erectile Function (IIEF) Overall Satisfaction Domain|Self-reported overall satisfaction over the past 4 weeks. IIEF overall satisfaction was the sum of Q13 and Q14. Scores ranged from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF overall satisfaction domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF overall satisfaction domain score. Higher IIEF overall satisfaction domain scores were indicative of greater overall satisfaction.|Baseline, Week 8, and Week 18|All randomized participants with baseline and at least 1 IIEF post-baseline measurement.|||units on a scale||Standard Deviation|Mean
2686206|NCT01352507|Secondary|Percentage of Participants Moderately or Strongly Preferring the Selected Treatment at Week 18 Using Question 2 of the PITPQ|"PITPQ Q2 was a measure of the degree of treatment preference based on the participant's opinion. The question was, For the treatment preference you selected in Q1, what is your degree of preference?. Choices were moderate or strong."|Week 18|Randomized participants who completed both treatment periods (Week 18), responded to the PITPQ, and were analyzed according to their assigned treatment.|||percentage of participants|||Number
2686207|NCT01352507|Primary|"Percentage of Participants Preferring Tadalafil Over Sildenafil Measured at Week 18 Using Question 1 of the Phosphodiesterase 5 Inhibitor Treatment Preference Questionnaire (PITPQ)"|PITPQ Question (Q) 1 was a dichotomous outcome measure in which the participant selected his preferred study treatment (tadalafil or sildenafil) to receive during the Extension Phase.|Week 18|Randomized participants who completed both treatment periods (Week 18), responded to the PITPQ, and were analyzed according to their assigned treatment.|||percentage of participants||95% Confidence Interval|Number
2686208|NCT01352468|Secondary|Proportion of Words Read Accurately Using the AIMSWEB|Number of words read correctly divided by number of words read|8 weeks||||proportion of words read accurately||Standard Deviation|Mean
2686209|NCT01352468|Secondary|Reaction Time Variability on go/No-go Task|Standard deviation of reaction times for correct responses to Go trials on a Go/No-Go Task|8 weeks|Go/No-Go task data was not available for one participant in the Sham Cognitive Training condition|||milliseconds||Standard Deviation|Mean
2686210|NCT01352468|Primary|Total ADHD Symptom Score From Vanderbilt ADHD Parent Rating Scale|"Total ADHD Symptom Score on the Parent Vanderbilt Rating Scales; range = 0-54; this score is computed by summing the 18 ADHD symptom items which are each rated on a 0-3 Likert scale (0=Never; 1=Occasionally; 2=Often; 3=Very often); higher scores indicate higher severity of ADHD symptoms."|8 weeks||||units on a scale||Standard Deviation|Mean
2686211|NCT01352442|Secondary|Subjective Rating of Near Visual Acuity at 12 Months as Measured by Subjective Questionnaire|Mean subjective rating via questionnaire on 1 to 7 rating scale (1= very dissatisfied and 7 = very satisfied).|12 months||||Scores on a scale||95% Confidence Interval|Mean
2686212|NCT01352442|Primary|Uncorrected Near Visual Acuity 20/32 or Better||12 months||||percentage of subjects|||Number
2686213|NCT01352416|Primary|Freedom From Any Episode of Post Operative Atrial Fibrillation Longer Than 6 Hours Duration Occurring During the Study Period.|Freedom from any episode of post operative Atrial Fibrillation (AF) longer than 6 hours duration occurring during the study period. To document post operative atrial fibrillation.|The time between the completion of the operation and hospital discharge or 14 days post operative if the hospitalzation is prolonged|Study was prematurely terminated. Data for this Outcome Measure were not collected||||||
2686214|NCT01352286|Secondary|Engraftment of Gene-modified Pentamer+ CD4+ T Cells and CD8+ T Cells|Number of participants with engraftment in blood and bone marrow|Post Treatment|Participants who received NYESO-1ᶜ²⁵⁹T following ASCT with engraftment data.|||participants|||Number
2686215|NCT01352286|Secondary|Marrow Antigen Expression Pre-and Post-infusion|Number of participants with NY-ESO-1 and LAGE or LAGE-1a expression in the marrow post-infusion|Pre- and post-infusion|Participants who received NYESO-1ᶜ²⁵⁹T following ASCT with expression data at all points.|||participants|||Number
2686216|NCT01352286|Secondary|Peak Persistence of Modified T-cells in the Peripheral Blood|Measurement of NY-ESO-1ᶜ²⁵⁹T cells in blood|Post-infusion through Day 42|Participants who received NYESO-1ᶜ²⁵⁹T following ASCT|||copies per μg of DNA||Full Range|Mean
2686217|NCT01352286|Secondary|Duration of Response (DOR), Progression Free Survival (PFS), Overall Survival (OS)|Calculated median DOR, PFS, OS|DOR: Initial date of response to date of progressive disease or death PFS: Date of first T -cell infusion to earliest date of disease progression of death due to any cause OS: Date of first T-cell infusion to date of death from any cause.|Participants who received NYESO-1ᶜ²⁵⁹T following ASCT|||median months||95% Confidence Interval|Median
2686283|NCT01351506|Secondary|Acute Kidney Injury|New acute kidney injury in ICU|Acute kidney injury||||participants|||Number
2703737|NCT01216631|Secondary|Pain Visual Analogue Scale|Change in patient's assessment of pain by a 100mm visual analogue score|2 weeks|||||||
2686219|NCT01352286|Secondary|Number of Participants With Response Per International Myeloma Working Group (IMWG) 2011 Criteria|Objective Response Rate (ORR) of sCR (stringent complete response), CR (complete response), VGPR (very good partial response), PR (partial response)|Change from Baseline at Day 42, 100, 180, 270 and Year 1|Participants who received NYESO-1ᶜ²⁵⁹T following ASCT|||Participants|||Count of Participants
2686220|NCT01352286|Primary|Adverse Events Related to Study Treatment|Number of Participants with Adverse Events related to study treatment|Day -40 to Year 1 post-treatment|Participants who received NYESO-1ᶜ²⁵⁹T following ASCT|||participants|||Number
2686221|NCT01352221|Other Pre-specified|Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 64 (Full Analysis Set, FAS)|"Change from baseline in Crohn's Disease Activity Index (CDAI) score at Week 64 (FAS), after 12-week double blind phase and 52 weeks open-label ST10 treatment (in participants with CD only).~The CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI score can range from 0 to approximately 600. Traditionally, for clinical trials, clinical remission is defined as a CDAI score <150, clinical response is a decrease in CDAI score of 70-100. Mildly active Crohn's disease is defined as a CDAI score 150-220, moderate-severe Crohn's is typically a CDAI 220-450, and severe disease is defined as a CDAI >450."|Baseline to Week 64 - open-label phase|FAS|||score on a scale||Full Range|Median
2686222|NCT01352221|Other Pre-specified|Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 12 (Full Analysis Set, FAS)|"Change from baseline (randomisation) in Crohn's Disease Activity Index (CDAI) score at Week 12 (FAS), end of double-blind phase (in subjects with CD).~The CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI score can range from 0 to approximately 600. Traditionally, for clinical trials, clinical remission is defined as a CDAI score <150, clinical response is a decrease in CDAI score of 70-100. Mildly active Crohn's disease is defined as a CDAI score 150-220, moderate-severe Crohn's is typically a CDAI 220-450, and severe disease is defined as a CDAI >450."|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)|||score on a scale||Full Range|Median
2686223|NCT01352221|Other Pre-specified|Irritable Bowel Disease Questionnaire (IBDQ) Score at Week 64 (Full Analysis Set, FAS)|"Irritable Bowel Disease Questionnaire (IBDQ) score at Week 64 (FAS), after 12-week double-blind phase and 52 weeks of open-label ST10 treatment.~The IBDQ was developed as an activity index for determining the effect of Crohn's disease symptoms on perceived quality of life. It is a 32-item questionnaire with four dimensions: bowel function, emotional status, systemic symptoms and social function. Total IBDQ score ranges from 32 to 224, with higher scores indicating better quality of life. The score of patients in remission usually is between 170 and 190."|Week 64 - open-label phase|FAS|||score on a scale||Standard Deviation|Mean
2686224|NCT01352221|Other Pre-specified|Irritable Bowel Disease Questionnaire (IBDQ) Score at Week 12 (Full Analysis Set, FAS)|"Irritable Bowel Disease Questionnaire (IBDQ) score at Week 12 (FAS), end of double-blind phase.~The IBDQ was developed as an activity index for determining the effect of Crohn's disease symptoms on perceived quality of life. It is a 32-item questionnaire with four dimensions: bowel function, emotional status, systemic symptoms and social function. Total IBDQ score ranges from 32 to 224, with higher scores indicating better quality of life. The score of patients in remission usually is between 170 and 190."|Week 12 - double-blind phase|Full Analysis Set (FAS)|||score on a scale||Standard Deviation|Mean
2686225|NCT01352221|Other Pre-specified|Change in Serum TSAT% From Baseline to Week 64 (Full Analysis Set, FAS)|Change in serum TSAT% from Baseline to Week 64 (Full Analysis Set), after 12-week double-blind phase and 52 weeks open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS|||percent||Standard Deviation|Mean
2686226|NCT01352221|Other Pre-specified|Change in Serum Ferritin Concentration From Baseline to Week 64 (Full Analysis Set, FAS)|Change in serum Ferritin concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and 52 weeks open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS|||μg/dL||Standard Deviation|Mean
2686227|NCT01352221|Other Pre-specified|Change in Serum TSAT% From Baseline to Week 12 (Full Analysis Set, FAS)|Change in serum TSAT% from Baseline to Week 12 (FAS), after 12-week double-blind phase|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)|||percent||Standard Deviation|Mean
2686228|NCT01352221|Other Pre-specified|Change in Serum Ferritin Concentration From Baseline to Week 12 (Full Analysis Set, FAS)|Change in serum Ferritin concentration from Baseline to Week 12 (Full Analysis Set), after 12-week double-blind phase|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)|||μg/dL||Standard Deviation|Mean
2686229|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 12 (Full Analysis Set [FAS] LOCF)|ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF - Change in Haemoglobin Concentration from Baseline to Week 12|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)|||g/dL||Standard Deviation|Mean
2686230|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 12 (Per Protocol Analysis Set, PPAS)|ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS - Change in Haemoglobin Concentration from Baseline to Week 12|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)|||g/dL||Standard Deviation|Mean
2686231|NCT01352221|Secondary|Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 64 (Full Analysis Set, FAS)|Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 64 (Full Analysis Set), after 12-week double-blind phase and 52 weeks of open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS|||Participants|||Count of Participants
2686232|NCT01352221|Secondary|Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 36 (Full Analysis Set, FAS)|Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 36 (Full Analysis Set), after 12-week double-blind phase and 24 weeks of open-label ST10 treatment|Baseline to Week 36 - open-label phase|FAS|||Participants|||Count of Participants
2686233|NCT01352221|Secondary|Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 16 (Full Analysis Set, FAS)|Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 16 (Full Analysis Set), after 12-week double-blind phase and first 4 weeks of open-label ST10 treatment|Baseline to Week 16 - open-label phase|FAS|||Participants|||Count of Participants
2686284|NCT01351506|Secondary|Re Intubation Within 72 Hours|Patient who need re-intubation within 72 hours|ICU complications up to 28 days after ICU admission|All|||participants|||Number
2686234|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 64 EOS (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 64 EOS (FAS) - Week 64 was re-categorised as Week 64 EOS for those subjects who withdrew from the study early and the 'Week 64' visit was outside the visit window of 64 weeks ± 2 days|Baseline to Week 64 EOS - open-label phase|FAS|||g/dL||Standard Deviation|Mean
2686235|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 64 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and then 52 weeks of open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
2686236|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 48 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 48 (FAS), after 12-week double-blind phase and then 36 weeks of open-label ST10 treatment|Baseline to Week 48 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
2686237|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 36 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 36 (FAS), after 12-week double-blind phase and then 24 weeks of open-label ST10 treatment|Baseline to Week 36 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
2686238|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 24 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 24 (FAS), after 12-week double-blind phase and then 12 weeks of open-label ST10 treatment|Baseline to Week 24 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
2686239|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 20 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 20 (FAS), after 12-week double-blind phase and then 8 weeks of open-label ST10 treatment|Baseline to Week 20 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
2686240|NCT01352221|Secondary|Change in Haemoglobin Concentration From Baseline to Week 16 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 16 (FAS), after 12-week double-blind phase and first 4 weeks of open-label ST10 treatment.|Baseline to Week 16 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
2686241|NCT01352221|Secondary|Change in Hb Concentration From Baseline to Week 8 (Full Analysis Set, FAS)|ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation|Baseline to Week 8 - double-blind phase|FAS|||g/dL||Standard Deviation|Mean
2686242|NCT01352221|Secondary|Change in Hb Concentration From Baseline to Week 4 (Full Analysis Set, FAS)|ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation|Baseline to Week 4 - double-blind phase||||g/dL||Standard Deviation|Mean
2686243|NCT01352221|Secondary|Proportion of Subjects That Achieved Hb Concentration Within Normal Range at Week 12 (Full Analysis Set, FAS)|Logistic regression analysis of proportion of subjects that achieved Hb concentration within normal range at Week 12 end of double-blind phase|Baseline to Week 12 - double-blind phase|FAS|||Participants|||Count of Participants
2686244|NCT01352221|Secondary|Proportion of Subjects That Achieved ≥2 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS)|Logistic regression analysis of proportion of subjects that achieved ≥2 g/dL change from baseline in Hb concentration at Week 12 in the double-blind phase|Baseline to Week 12 - double-blind phase|FAS|||Participants|||Count of Participants
2686245|NCT01352221|Secondary|Proportion of Subjects That Achieved ≥1 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS)|Logistic regression analysis of proportion of subjects that achieved ≥1 g/dL change from baseline in Hb concentration at Week 12 in the double-blind phase|Subjects that achieved ≥1 g/dL change from baseline in Hb concentration at Week 12 - double-blind phase|FAS|||Participants|||Count of Participants
2686246|NCT01352221|Primary|Change in Haemoglobin (Hb) Concentration From Baseline to Week 12 (Full Analysis Set, FAS)|Primary efficacy endpoint, defined as the change in Hb concentration from Baseline to Week 12. Baseline was defined as the pre-dose Hb concentration measured at the Randomisation Visit (Week 0). Missing Randomisation Hb values were replaced by Screening Hb values, if the randomisation was within the protocol-specified window. Hb concentration (g/dL) was analysed by a central laboratory from blood samples collected at every clinic visit: Screening, Randomisation (Week 0), Weeks 4, 8, 12, 14, 16, 20, 24, 36, 48, 64, Weeks 14 to 64 were open-label. The baseline, absolute concentration and change from baseline in Hb at all post-randomisation visits were listed and summarised by week using descriptive statistics. An analysis of covariance (ANCOVA) was used to analyse the primary endpoint; this included treatment, gender and disease as factors and baseline Hb as a covariate.|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)|||g/dL||Standard Deviation|Mean
2686247|NCT01352117|Secondary|Cumulative Incidence of KS Response After Initiation of Delayed Etoposide in Arm A|KS response, partial or complete (PR or CR) compared to Step 2 entry (prior to initiation of delayed ET) based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 2 (at up to 84 weeks or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.|From initiation of etoposide (Step 2 entry) to up to 84 weeks (end of Step 2)|All Arm A participants who experienced KS progression and entered Step 2 to initiate delayed ET.|||cumulative events per 100 participants||95% Confidence Interval|Number
2686248|NCT01352117|Secondary|Cumulative Incidence of KS Progressive Disease After Initiation of Delayed Etoposide in Arm A|KS progressive disease (PD) compared to Step 2 entry (prior to initiation of delayed ET) or Step 2 best response based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 2 (at up to 84 weeks or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.|From initiation of etoposide (Step 2 entry) to up to 84 weeks (end of Step 2)|All Arm A participants who experienced KS progression and entered Step 2 to initiate delayed ET.|||cumulative events per 100 participants||95% Confidence Interval|Number
2686249|NCT01352117|Secondary|Change in Peripheral Blood CD4+ Lymphocyte Cell Count|Absolute change in CD4+ cell count was calculated as value at a given visit minus the value at study screening in Step 1, and as value at a given visit minus Step 2 entry in Step 2. Only participants in Arm A could enter Step 2 to initiate delayed ET.|Screening and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.|All eligible participants who initiated study treatment and had CD4 cell count results available at screening and the respective Step 1 visit or at Step 2 entry and the respective Step 2 visit.|||cells/mm^3||Inter-Quartile Range|Median
2686250|NCT01352117|Secondary|Change in log10 HIV-1 Plasma Viral Load From Entry|Absolute change in log10 HIV-1 RNA from entry at study visits calculated as value at a given time point minus value at entry. This outcome was initially specified in the study protocol. However, at the first post-entry visit, most participants had unquantifiable HIV-1 RNA levels. It would be misleading to calculate change from entry to HIV RNA-1 levels that could not be quantified. Therefore, the data collected did not support the outcome and the analytic method initially proposed in the study protocol, and this outcome measure could not be analyzed. The SAP updated the HIV-1 RNA outcome measure to HIV-1 RNA suppression at study visits (please refer to the secondary outcome measure #20).|Entry and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.|At the first post-entry visit, most participants had unquantifiable HIV-1 RNA levels. Therefore, this outcome measure could not be analyzed.||||||
2686251|NCT01352117|Secondary|Percentage of Participants With ARV Dose Modification|ARV dose modifications were reported as temporarily held, prematurely discontinued and increased. The percentage of participants who experienced each dose modification is provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple dose modifications and may be counted in more than one category. Each participant is counted at most once within category.|From treatment dispensation to Week 96|All eligible participants who initiated study treatment.|||percentage of participants|||Number
2686252|NCT01352117|Secondary|Percentage of Participants With HIV-1 RNA Suppression|HIV-1 RNA suppression was defined as plasma HIV-1 RNA <400 copies/mL. Only Arm A participants could enter Step 2 to initiate delayed ET.|Entry and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.|All eligible participants who initiated study treatment and had HIV-1 RNA results available at the specific visit. HIV-1 RNA testing was done locally using Abbott RealTime HIV-1 Test or Roche AmpliPrep/Taqman HIV-1 Test. Only Arm A participants could enter Step 2 to initiate delayed ET.|||percentage of participants|||Number
2686253|NCT01352117|Secondary|Percentage of Participants With Etoposide Dose Modification|Etoposide (ET) was administered for a maximum of 8 cycles (16 weeks) from study entry (Arm B) or from Step 2 entry (Arm A). Dose modifications were reported as temporarily held, resumed at a different dose, deferred, prematurely discontinued and underdosed. The percentage of participants who experienced each dose modification is provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple dose modifications and may be counted in more than one category. Each participant is counted at most once within category.|From ET dispensation to ET discontinuation (total duration of ET was up to 16 weeks)|All eligible participants who initiated study treatment. Arm A participants are limited to those who entered Step 2 to initiate delayed ET.|||percentage of participants|||Number
2686254|NCT01352117|Secondary|Cumulative Incidence of KS-IRIS|KS-IRIS was defined as KS progressive disease that occurs within 12 weeks of initiation of ART that is associated with an increase in peripheral blood CD4+ lymphocyte cell count of at least 50 cells/mm^3 above the study screening value and/or a decrease in the HIV RNA level by at least 0.5 log10 below the study entry value prior to, or at the time of, documented KS progressive disease. Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored (1) when lost to follow-up, (2) at the study visit following Week 12 or (3) on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. Time of KS-IRIS was defined as the time of the initial KS progressive disease.|From study entry to Week 12|All eligible participants who initiated study treatment.|||cumulative events per 100 participants||95% Confidence Interval|Number
2686255|NCT01352117|Secondary|Number of Participants With Grade 3 or Higher Adverse Events|Number of participants who experienced an AE (sign/symptom or laboratory abnormality) of Grade 3 or higher. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see reference in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening.|From study treatment dispensation through up to Week 96, until long-term follow-up began in Step 3 or until study discontinuation.|All eligible participants who initiated study treatment.|||Participants|||Count of Participants
2686256|NCT01352117|Secondary|Cumulative Incidence of Initial KS Complete Response by Week 96|"KS complete response (CR) compared to study entry based on clinical evaluation of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). This was initially part of the outcome specified in the study protocol as PR and CR combined and separately to address the secondary objective on the KS response. Due to the extremely limited number of participants with KS CR, the Statistical Analysis Plan was updated, and the Final Analysis was conducted only on the combined KS response. The outcome on CR separately was withdrawn."|From study treatment initiation to 96 weeks|Due to the extremely limited number of participants with KS CR, KS partial response (PR) and CR were combined. The analyses of CR and PR separately which were initially specified in the study protocol were withdrawn.||||||
2686257|NCT01352117|Secondary|Cumulative Incidence of Initial KS Partial Response by Week 96|"KS partial response (PR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). This was initially part of the outcome specified in the study protocol as PR and CR combined and separately to address the secondary objective on the KS response. Due to the extremely limited number of participants with KS complete response, the Statistical Analysis Plan was updated, and the Final Analysis was conducted only on the combined KS response. The outcome on PR separately was withdrawn."|From study treatment initiation to 96 weeks|Due to the extremely limited number of participants with KS CR, KS partial response (PR) and CR were combined. The analyses of CR and PR separately which were initially specified in the study protocol were withdrawn.||||||
2686258|NCT01352117|Secondary|Cumulative Incidence of Initial KS Partial or Complete Response by Week 96|KS partial response (PR) or complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of delayed KS treatment (alternate KS treatment or delayed ET in Arm A) as competing risks. Time at risk was censored at the end of Step 1 (Week 96 or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.|From entry through 96 weeks|All eligible participants who initiated study treatment.|||cumulative events per 100 participants||95% Confidence Interval|Number
2686259|NCT01352117|Secondary|Cumulative Incidence of Initial KS Progressive Disease by Week 96|KS progressive disease (PD) compared to study entry or best response based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 1 (Week 96 or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.|From entry through 96 weeks|All eligible participants who initiated study treatment.|||cumulative events per 100 participants||95% Confidence Interval|Number
2686260|NCT01352117|Secondary|Premature Study Discontinuation by Week 96|Premature study discontinuation by Week 96 due to any reason, including death.|Entry through Week 96|All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public).|||Participants|||Count of Participants
2686261|NCT01352117|Secondary|KS Partial or Complete Response at Week 96 Compared to Study Entry|KS partial response (PR) or complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 96|All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.|||Participants|||Count of Participants
2686262|NCT01352117|Secondary|KS Complete Response at Week 96 Compared to Study Entry|KS complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 96|All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.|||Participants|||Count of Participants
2686263|NCT01352117|Secondary|KS Partial Response at Week 96 Compared to Study Entry|KS partial response (PR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 96|All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.|||Participants|||Count of Participants
2686264|NCT01352117|Secondary|KS Progressive Disease at Week 96 Compared to Study Entry|KS progressive disease (PD) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 96|All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.|||Participants|||Count of Participants
2686265|NCT01352117|Secondary|Kaposi Sarcoma (KS) Status at Week 96 Compared to Study Entry|KS status is a composite, categorical outcome, ordered from worst to best as E1 (Failure: KS PD, initiation of an alternate KS treatment, or no follow-up at Week 96 including death and missed visit), E2 (Stable: in follow-up at Week 96 with no KS progression nor response and without initiation of an alternate KS treatment) and E3 (Response: in follow-up at Week 96, with KS PR or CR and without initiation of an alternate KS treatment). Alternate KS treatment was defined as chemotherapy agent other than ET or other treatment triggered by worsening KS. KS outcome status (PD, stable, PR or CR) compared to study entry was evaluated at Week 96 based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Data on initiation of alternate KS treatment, loss to follow-up and deaths are from entry through Week 96.|Entry through Week 96.|All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public).|||Participants|||Count of Participants
2686266|NCT01352117|Secondary|Premature Study Discontinuation by Week 48|Premature study discontinuation by Week 48 due to any reason, including death.|Entry through Week 48|All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public).|||Participants|||Count of Participants
2686267|NCT01352117|Secondary|KS Partial or Complete Response at Week 48 Compared to Study Entry|KS partial response (PR) or complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 48|All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.|||Participants|||Count of Participants
2686268|NCT01352117|Secondary|KS Complete Response at Week 48 Compared to Study Entry|KS complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 48|All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.|||Participants|||Count of Participants
2686269|NCT01352117|Secondary|KS Partial Response at Week 48 Compared to Study Entry|KS partial response (PR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 48|All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.|||Participants|||Count of Participants
2686270|NCT01352117|Secondary|KS Progressive Disease at Week 48 Compared to Study Entry|KS progressive disease (PD) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).|Entry and Week 48|All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.|||Participants|||Count of Participants
2686271|NCT01352117|Primary|Kaposi Sarcoma (KS) Status at Week 48 Compared to Study Entry|KS status is a composite, categorical outcome, ordered from worst to best as E1 (Failure: KS progression (PD), initiation of an alternate KS treatment, or no follow-up at Week 48 including death and missed visit), E2 (Stable: in follow-up at Week 48 with no KS PD nor response and without initiation of an alternate KS treatment) and E3 (Response: in follow-up at Week 48, with KS partial or complete response (PR or CR) and without initiation of an alternate KS treatment). Alternate KS treatment was defined as chemotherapy agent other than ET or other treatment triggered by worsening KS. KS outcome status (PR, stable, PR, CR) compared to study entry was evaluated at Week 48 based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Data on initiation of alternate KS treatment, loss to follow-up and dea|Entry through Week 48.|All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the Data and Safety Monitoring Board's [DSMB] recommendation to close the study became public).|||Participants|||Count of Participants
2686272|NCT01351740|Secondary|Quality of Life as Assessed by MOS-HIV|Changes in MOS-HIV scores from baseline will be compared between randomized treatment arms.|24 and 48 weeks|||||||
2686273|NCT01351740|Secondary|Metabolic Parameters|Comparison will be made between randomized treatment arms with respect to changes in fasting lipids and glucose, highly sensitive C-reactive protein [hsCRP], and apolipoprotein [apo]B, and proportions of subjects developing abnormalities or crossing predefined limits (e.g. NCEP thresholds for lipids)|24 and 48 weeks|||||||
2686274|NCT01351740|Secondary|Total Serum Bilirubin Levels|Comparison will be made between randomized treatment arms.|24 and 48 weeks|||||||
2686275|NCT01351740|Secondary|Safety (Clinical and Laboratory Adverse Events)|Serious adverse events and discontinuations will be compared between randomized treatment arms|24 and 48 weeks|||||||
2686276|NCT01351740|Secondary|CD4 Cell Count Changes (Absolute and Fraction)|Comparison will be made between randomized treatment arms.|24 and 48 weeks|||||||
2686277|NCT01351740|Secondary|Proportion of Subjects Experiencing Virologic Failure by Results of 1-month TDM|For the purposes of the study, virologic failure is defined as either regimen change for any reason, or plasma viral load >400 copies/mL on 2 consecutive measurements >2 weeks apart. Comparison will be made between subjects with 1-month (4-8 week) on-study atazanavir trough levels <150ng/mL and those with 1-month (4-8 week) on-study atazanavir trough levels >150ng/mL.|at or before 24 weeks|||||||
2686278|NCT01351740|Secondary|Proportions of Subjects Experiencing Virologic Failure by Randomized Treatment Arm|For the purposes of the study, virologic failure is defined as either regimen change for any reason, or plasma viral load >400 copies/mL on 2 consecutive measurements >2 weeks apart.|at or before 24 weeks.|||||||
2686279|NCT01351740|Secondary|Proportion of Subjects Experiencing Virologic Failure by Results of 1-month TDM|For the purposes of the study, virologic failure is defined as either regimen change for any reason, or plasma viral load >400 copies/mL on 2 consecutive measurements >2 weeks apart. Comparison will be made between subjects with 1-month (4-8 week) on-study atazanavir trough levels <150ng/mL and those with 1-month (4-8 week) on-study atazanavir trough levels >150ng/mL.|at or before 48 weeks|||||||
2686280|NCT01351740|Secondary|Proportions of Subjects in Each Randomized Treatment Arm With Atazanavir Trough Levels Below 150ng/mL|Therapeutic drug monitoring (TDM) to determine atazanavir trough plasma level will be performed once on all subjects at 4-8 weeks|1 month (4-8 weeks)||||Participants|||Count of Participants
2686281|NCT01351740|Primary|Proportions of Subjects Experiencing Virologic Failure by Randomized Treatment Arm|For the purposes of the study, virologic failure is defined as either regimen change for any reason, or plasma viral load >400 copies/mL on 2 consecutive measurements >2 weeks apart.|at or before 48 weeks.||||Participants|||Count of Participants
2686282|NCT01351623|Primary|To Evaluate the Best Overall Response Rate (ORR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); POD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions|2 years|Participants who completed 4 cycles of treatment or whose disease progressed prior to completion of 4 cycles.|||Participants|||Count of Participants
2686287|NCT01351480|Secondary|the Clinical Outcomes Measurements (American College of Rheumatology Activity Scoring, Health Assessment The Number of Patients With a Clinical Response at Week 24 and 48|Patient with a positive change in DAS score were considered responders . The DAS score is calculated using the number of tender and swollen joints based upon a 28 joint count, the ESR in mm/hr., and the physician global score (1-10 cm). Total maximum score was at high disease activity at baseline.|week 24 and Week 48|There were 34 enrolled patients with 7 patients who early termed so analysis was performed on 27 patients|||participants|||Number
2686288|NCT01351480|Secondary|To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24|DAS 28> 5.1=high disease activity DAS28 <3.2=low disease activity DAS28 <2.6=remission Criteria used in formula are number of tender joints based upon 28 joints, number of swollen joints based on 28 joints, ESR in mm/hr and patient global health core based on 0-10 mm|Patient DAS 28 scores will be measured at baseline and weeks 12, 24, 48 and disease activity will be recorded at Week 48|the number of participants who reached remission, low disease activity, moderate disease activity and high disease activity will be determined as based upon the DAS scale|||participants|||Number
2686289|NCT01351480|Secondary|Patients With an Improvement in DAS Score Were Considered Responders at Week 48|Patient with a positive change in DAS score were considered responders . The DAS score is calculated using the number of tender and swollen joints based upon a 28 joint count, the ESR in mm/hr., and the physician global score|The DAS 28 score will be performed at baseline and 48|There were 34 enrolled patients with 7 patients who early termed so analysis was performed on 27 patients|||participants|||Number
2686290|NCT01351480|Primary|Number of Participants With an Improvement in Bone Edema/Osteitis on Low-field MRI in Rheumatoid Arthritis Patients on Weekly SC Abatacept in Combination With Methotrexate Over a 12-month Period.|bone edema/osteitis using low-field MRI analysis of 25 anatomical locations in the wrist and hand and scoring the volume of the original articular bone in 0.5 increments from 0-3, with each increment in the scale representing 33% of the volume of the peripheral 1 cm of original (eroded + residual) articular bone.|MRIs at Baseline and Week 48|osteitis on the MRIs from 27 patients at baseline and week 48|||participants|||Number
2686291|NCT01351415|Secondary|Percentage of Participants Who Are Alive at Month 6, 12, and 18|Percentage of participants who were alive at Month 6, 12 and 18 were reported.|Month 6, 12, 18|Intent to treat population included all randomized participants.|||Percentage of Participants||90% Confidence Interval|Number
2686292|NCT01351415|Secondary|Time to Progression (TTP) According to RECIST v1.1|The time to progression was defined as the time from baseline until disease progression as determined by the RECIST v1.1. TTP2 is defined as the interval between the day of randomization at PD1 and PD2. TTP3 is defined as the interval between the day of PD2 and PD3. PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.|Up to data cut-off date 24 June 2016 (approximately 5 years)|Intent to treat population included all randomized participants.|||Months||90% Confidence Interval|Median
2686293|NCT01351415|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.|Up to data cut-off date 24 June 2016 (approximately 5 years)|The safety population included all participants who had received at least one dose of any study drug.|||Percentage of Participants|||Number
2686294|NCT01351415|Secondary|Duration of Response (DoR) According to RECIST v1.1|Duration of response is defined as the time that measurement criteria are met for objective response (CR/PR) (whichever status is recorded first) until the first date of progression or death is documented. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than < 10 mm. PR was defined as greater than or equal to ≥30 % decrease in sum of longest diameter of target lesions in reference to baseline sum longest diameter.|Up to data cut-off date 24 June 2016 (approximately 5 years)|Intent to treat population included all randomized participants.|||Months||90% Confidence Interval|Median
2686295|NCT01351415|Secondary|Percentage of Participants With Disease Control According to RECIST v1.1|The disease control rate is defined as CR or PR or stable disease (SD) assessed according to the RECIST v.1.1 criteria with baseline tumour assessment as the reference. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since treatment started for target lesions and the persistence of 1 or more non-target lesions.|Up to data cut-off date 24 June 2016 (approximately 5 years)|Intent to treat population included all randomized participants.|||Percentage of Participants||90% Confidence Interval|Number
2686296|NCT01351415|Secondary|Percentage of Participants With Objective Response According to RECIST v1.1|The objective response is defined as complete response (CR) or partial response (PR) assessed according to the RECIST v.1.1 criteria with baseline tumour assessment as the reference. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.|Up to data cut-off date 24 June 2016 (approximately 5 years)|Intent to treat population included all randomized participants.|||Percentage of Participants||90% Confidence Interval|Number
2686334|NCT01351025|Secondary|Number of Participants With Safety Endpoints After Study Treatment Cross-over (Week 24 to Week 48)|"Safety endpoints are defined as grade ≥ 2 signs and symptoms, laboratory abnormalities, AST/ALT > 3 X ULN, and adverse events after study treatment cross-over (week 24 to week 48).~The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs."|week 24 to week 48|participants who crossed over study treatment at week 24|||participants|||Number
2686297|NCT01351415|Secondary|Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PFS2 is defined as the time between randomization at PD1 and the date of PD2 or death, whichever occurs first. PFS3 is defined as the time between PD2 and the date of PD3 or death, whichever occurs first.|Up to data cut-off date 24 June 2016 (approximately 5 years)|Intent to treat population included all randomized participants.|||Months||90% Confidence Interval|Median
2686298|NCT01351415|Primary|Overall Survival (OS)|Overall survival (OS) was defined as the time from the date of randomization at first progression of disease to the date of death, regardless of the cause of death.|Up to data cut-off date 24 June 2016 (approximately 5 years)|Intent to treat population included all randomized participants.|||Months||90% Confidence Interval|Median
2686299|NCT01351376|Secondary|Short-Form Health Survey (SF-36)|Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health. The individual question items (Likert scale 0-4) are first summed for each item under the various sections. Then, those summary scores are then standardized on a scale between 0 and 1 using the mean and standard deviation of the actual scores and finally, weighted to a scale between 0 and 100. The items contributing to a scale are scored so that a higher score represents better health, and they are averaged together to create the scale score. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.|13 months||||score on a scale||Standard Deviation|Mean
2686300|NCT01351376|Primary|Arm Volume||13 Months||||cm^3||Standard Deviation|Mean
2686301|NCT01351350|Primary|Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events(SAEs), AEs Resulting in Discontinuation of MLN0128 and Fatal AEs Within 30 Days of Last Dose of Study Drug|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.|First dose of study drug through 30 days after the administration of the last dose of study drug (Up to approximately 91.4 weeks)|All Subjects as Treated (ASaT) population consisted of all enrolled participants who received at least 1 dose of MLN0128, was used in the safety analyses.|||percentage of participants|||Number
2686302|NCT01351350|Secondary|Vss: Volume of Distribution at Steady State Calculated Using the Observed Value of the Last Quantifiable Concentration for Paclitaxel||Cycle 1 Day 1|PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate 1 or more PK parameters. Vss data is only available for participants in the MLN0128P 6,7,9 and 10 mg QD×3d QW arms.|||L||Full Range|Mean
2686303|NCT01351350|Secondary|CL: Total Clearance Calculated Using the Observed Value of the Last Quantifiable Concentration for Paclitaxel||Cycle 1 Day 1|PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate 1 or more PK parameters. CL data is only available for participants in the MLN0128P 6,7,9 and 10 mg QD×3d QW arms.|||L/hr||Full Range|Mean
2686304|NCT01351350|Secondary|AUC(0-24): Area Under the Plasma Concentration-time Curve Extrapolated to 24 Hours for Paclitaxel||Cycle 1 Day 1|PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate 1 or more PK parameters. AUC0-24 data is only available for participants in the MLN0128P 6,7,9 and 10 mg QD×3d QW arms.|||ng*hr/mL||Full Range|Mean
2686305|NCT01351350|Secondary|AUC(0-6): Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours for Paclitaxel||Cycle 1 Day 1|Participants from the PK population, all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate 1 or more PK parameters, with data available for analyses.|||ng*hr/mL||Full Range|Mean
2686306|NCT01351350|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Paclitaxel||Cycle 1 Day 1|PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate 1 or more PK parameters. AUC∞ data is only available for participants in the MLN0128P 6,7,9 and 10 mg QD×3d QW arms.|||ng*hr/mL||Full Range|Mean
2686307|NCT01351350|Secondary|Terminal Phase Elimination Half-life (T1/2) for Paclitaxel||Cycle 1 Day 1|PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate 1 or more PK parameters. T1/2 data is only available for participants in the MLN0128P 6,7,9 and 10 mg QD×3d QW arms.|||hours||Full Range|Mean
2686308|NCT01351350|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Paclitaxel||Cycles 1 and 2: Day 1|PK population consisted of all participants enrolled during Dose Escalation phase of study who received at least 1 dose of MLN0128 or paclitaxel and had sufficient concentration-time data to calculate PK parameters for either compound. Here, number analyzed is the number of participants with data available for analysis at the given time-point.|||hours||Full Range|Median
2686335|NCT01351025|Secondary|Number of Participants With Safety Endpoints Before Study Treatment Cross-over (Baseline to Week 24)|"Safety endpoints are defined as grade ≥ 2 signs and symptoms, laboratory abnormalities, AST/ALT > 3 X ULN, and adverse events prior to study treatment cross-over (baseline to week 24).~The DAIDS Adverse Event (AE) Grading Table, Version 1.0, December 2004 (Clarification, August 2009) was used for grading of AEs."|week 0 to week 24|participants who started study treatment|||participants|||Number
2686309|NCT01351350|Secondary|Cmin: Minimum Observed Plasma Concentration for Paclitaxel|Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i e, C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms.|Cycles 1 and 2: Day 1 or 2|Due to the change in planned analysis, minimum plasma concentration data was not collected.||||||
2686310|NCT01351350|Secondary|Cmax: Maximum Observed Plasma Concentration for Paclitaxel||Cycles 1 and 2: Day 1|PK population included all participants enrolled during Dose Escalation phase, received at least 1 dose of paclitaxel and had sufficient concentration-time data to calculate PK parameters, with data available for Cmax. Here, number analyzed is the number of participants with data available for analysis at the given time-point.|||ng/mL||Full Range|Mean
2686311|NCT01351350|Secondary|AUC(0-6): Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours for MLN0128|Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i e, C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 30 and 40 mg QW arms.|Cycles 1 and 2: Day 1 or 2|PK population included all participants enrolled during Dose Escalation phase, received at least 1 dose of MLN0128 and had sufficient concentration-time data to calculate PK parameters. Here, number analyzed is the number of participants with data available for analysis at the given time-point.|||ng*hr/mL||Full Range|Mean
2686312|NCT01351350|Secondary|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MLN0128||Cycle 1 Day 1|PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of MLN0128 and had sufficient concentration-time data to calculate 1 or more PK parameters. AUC∞ data is only available for 2 participants in each the MLN0128P 6 mg QD×3d QW and MLN0128P 7 mg QD×3d QW arms.|||ng*hr/mL||Full Range|Mean
2686313|NCT01351350|Secondary|Terminal Phase Elimination Half-life (T1/2) for MLN0128||Cycle 1 Day 1|PK population consisted of all participants enrolled during the Dose Escalation phase of the study who received at least 1 dose of MLN0128 and had sufficient concentration-time data to calculate 1 or more PK parameters. T1/2 data is only available for 2 participants in the MLN0128P 6 mg QD×3d QW and 2 participants in the MLN0128P 7 mg QD×3d QW arm.|||hours||Full Range|Mean
2686314|NCT01351350|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MLN0128|Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i.e., C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms.|Cycles 1 and 2: Day 1 or 2|PK population included all participants enrolled during Dose Escalation phase, received at least 1 dose of MLN0128 and had sufficient concentration-time data to calculate PK parameters, with data available for Tmax. Here, number analyzed is the number of participants with data available for analysis at the given time-point.|||hours||Full Range|Median
2686315|NCT01351350|Secondary|Cmin: Minimum Observed Plasma Concentration for MLN0128|Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i e, C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms.|Cycles 1 and 2: Day 1 or 2|Due to the change in planned analysis, minimum plasma concentration data was not collected.||||||
2686316|NCT01351350|Secondary|Cmax: Maximum Observed Plasma Concentration for MLN0128|Participants in the 6 mg QD×3d QW and 9 mg QD×3d QW were dosed with MLN0128 in conjunction with paclitaxel during Cycle 1 and Cycle 2 when PK was collected. Participants in the 7 mg QD×3d QW cohorts were dosed with paclitaxel during Cycle 1, but were subsequently switched to MLN0128 being dosed 24 hours after paclitaxel infusion Cycle 2 (i e, C2D2). In all the other dosing cohorts, MLN0128 was dosed 24 hours after paclitaxel infusion. Cycle 1: Data was collected at Day 1 for the 6, 7 and 9 mg QD×3d QW arms and at Day 2 for the 8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms. Cycle 2: Data was collected at Day 1 for the 6 and 9 mg QD×3d QW arms and at Day 2 for the 7,8 and 10 mg QD×3d QW, 7 mg QD×5d QW, 30 and 40 mg QW arms.|Cycles 1 and 2: Day 1 or 2|Pharmacokinetic (PK) population included all participants enrolled during Dose Escalation phase, received at least 1 dose of MLN0128 and had sufficient concentration-time data to calculate PK parameters, with data available for Cmax. Here, number analyzed is the number of participants with data available for analysis at the given time-point.|||ng/mL||Full Range|Mean
2686345|NCT01351025|Primary|Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in log10 IL-6|IL-6 (Interleukin 6) in log10 pg/mL: Difference between [change from week 24 to week 44] and [change from baseline to week 20] (i.e. [week 44 - week 24] - [week 20 - baseline])|baseline, week 20, week 24, and week 44|The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||log10 pg/mL||Inter-Quartile Range|Median
2686317|NCT01351350|Primary|Objective Response Rate (ORR)|ORR was defined as the percentage of participants with Complete Response (CR) and Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Each cycle was a 28 day cycle. CR was defined as the disappearance of all target lesions and for non-target lesions, the disappearance of all non-target lesions and normalization of tumor marker level. PR was defined of at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD and for non-target lesions.|At screening and thereafter every 2 cycles of treatment until disease progression (Up to 65.8 weeks)|Full Analysis Set (FAS) included all participants who received 1 or more doses of MLN0128 and have adequate baseline and post-baseline data collected.|||percentage of participants|||Number
2686318|NCT01351350|Primary|Dose Escalation Phase: Number of Participants With at Least 1 Dose Limiting Toxicity (DLT)|DLT was defined as any of the following occurring during Cycle 1 (Days 1-28) and attributable to MLN0128P: Grade ≥ 3 nonhematologic toxicity; Grade 3 thrombocytopenia with hemorrhage; Grade 4 neutropenia lasting > 7 days in the absence of growth factor support; Grade 4 neutropenia of any duration associated with fever 38.5 degrees C and/or infection; Any other Grade 4 hematologic toxicity; Inability to administer at least 75 % of doses of MLN0128 within Cycle 1 due to drug-related toxicity; Any clinically significant occurrence which the investigators and sponsor agree would place participants at undue safety risk; Participants who experienced an adverse event (AE) that met the definition for a DLT.|Cycle 1: Days 1 to 28|Dose-Escalation evaluable population included participants who received ≥ 75% of planned doses of MLN0128 in Cycle 1 or stopped study drug before receiving 75% of doses because of study drug-related AEs (considered as DLT).|||participants|||Number
2686319|NCT01351350|Primary|Dose Escalation Phase: Maximum Tolerated Dose (MTD)|MTD is the highest dose level at which the participants tolerate treatment without dose-limiting toxicities during the first cycle (28 days) of therapy.|Cycle 1: Days 1 to 28|Safety Population included all participants who received at least one dose of study drug.|||mg (QD×3d QW)|||Number
2686320|NCT01351337|Other Pre-specified|The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results|The sensitivity of DTI tractography for PT mapping was calculated as the ratio between the number of subjects with positive DsCS results in the positive DTI zone (true positive) and the total number of subjects with positive DsCS results (true positive plus false negative). The specificity was measured as the ratio between the number of subjects with negative DsCS results in the negative DTI zone (true negative) and the total number of subjects with negative DsCS results (true negative plus false positive). The accordance rate of DsCS and DTI was measured as the ratio between the number of subjects with either a true-positive or true-negative DsCS result and the total number of subjects.|During the operation||||percentage of stimulation sites|||Number
2686321|NCT01351337|Secondary|Postoperative Motor Function and Long-time Functional Status|Motor function was assessed early postoperatively (within 72 hours after the operation), and 1 month after discharge. The muscle strength of each subject was graded for both the upper and lower extremities with the Medical Research Council Scale. Grade 5: Muscle contracts against full resistance; Grade 4: Strength reduced, but contraction can still move joint against resistance; Grade 3: Strength further reduced such that joint can be moved only against gravity with examiner's resistance completely removed. Grade 2: Muscle can onlly move if resistance of gravity is removed. Grade 1: Only a trace or flicker of movement is seen or felt, or fasciculations are observed; Grade 0:No movement.|3 days to 6 months after surgery||||participants|||Number
2686322|NCT01351337|Primary|Extent of Tumor Resection|Volumetric analysis was performed both before and after surgery by calculating the tumor volume on the images of enhanced 3-D MP-RAGE sequence for high-grade gliomas and FLAIR sequence for low-grade gliomas. The extent of tumor resection was the ratio of pre-op tumor volume over post-op tumor volume. Gross total resection refers to a 100% resection of the tumor volume; near-total resection refers to 95% to 100% resection; subtotal resection refers to 90% to 95% resection; partial resection refers to 75% to 90% resection; and biopsy refers to ,75% resection of the tumor volume for histological diagnosis.|within 3 days||||participants|||Number
2686323|NCT01351090|Secondary|Pain Intensity Difference (PID) Scores|Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. PID was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication.|6 hours after study drug administration||||units on a scale||Standard Deviation|Mean
2686324|NCT01351090|Secondary|Total MS Use in Milligrams by PCA From 24 Hours After the Start of Dosing Through 48 Hours||8-hour intervals from 24 hours after the start of dosing through 48 hours||||mg||Standard Deviation|Mean
2686325|NCT01351090|Secondary|Total MS Use in Milligrams by PCA From the Start of Dosing Through 48 Hours||8-hour intervals from the start of dosing through 48 hours||||mg||Standard Deviation|Mean
2686326|NCT01351090|Primary|Total Morphine Sulfate (MS) Use in Milligrams by Patient-controlled Analgesia (PCA) Through 24 Hours||8-hour intervals from the start of dosing through 24 hours||||mg||Standard Deviation|Mean
2686327|NCT01351077|Other Pre-specified|Number of Patients Whose Referred Evaluations and Services Were Completed||one year||||Participants|||Count of Participants
2686328|NCT01351077|Other Pre-specified|Number of Children Referred for Evaluation and Services When There Was a Positive Screening Result||one year|The denominator was the number of children with a positive screen|||Participants|||Count of Participants
2686329|NCT01351077|Other Pre-specified|Number of Children With a Positive Screen||one year|The denominator was number of children for whom a standard developmental screening tool was administered|||Participants|||Count of Participants
2686330|NCT01351077|Secondary|Age of Children Diagnosed With Developmental Delay||one year|The denominator was only children diagnosed with developmental delay|||months||Standard Deviation|Mean
2686331|NCT01351077|Primary|Number of Children Screened for Developmental Delay||one year||||Participants|||Count of Participants
2686332|NCT01351064|Secondary|Percent of Patients Receiving ADHD Care Component||one year||||percentage of participants|||Number
2686333|NCT01351064|Primary|Number of Children Diagnosed With ADHD With Structured Diagnostic Assessment||one year||||number of kids|||Number
2686349|NCT01350999|Secondary|Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C)||Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
2686336|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in sCD163 (log10 Transformed)|"CD163 (Cluster of Differentiation 163) is a protein that in humans encoded by the CD163 gene; and sCD163 is soluble CD163.~Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||log10 ng/ml||Inter-Quartile Range|Median
2686337|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in P-selectin (log10 Transformed)|"P-selectin is a protein that in humans encoded by the SELP gene. P-selectin functions as a cell adhesion molecule (CAM) on the surfaces of activated endothelial cells, which line the inner surface of blood vessels, and activated platelets.~Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||log10 ng/ml||Inter-Quartile Range|Median
2686338|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in sCD14 (log10 Transformed)|Soluble cluster of differentiation 14 (sCD14) is a human gene. Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline].|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||log10 ng/ml||Inter-Quartile Range|Median
2686339|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in CD40L (log10 Transformed)|"Cluster of differentiation 40 (CD40L) is a costimulatory protein found on antigen presenting cells and is required for their activation.~Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||log10 pg/ml||Inter-Quartile Range|Median
2686340|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in IP-10 (log10 Transformed)|"IFN-gamma-inducible protein 10 (IP-10 or CXCL10) is a chemokine secreted from cells stimulated with type I and II IFNs and LPS, is also a chemoattractant for activated T cells.~Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||log10 pg/ml||Inter-Quartile Range|Median
2686341|NCT01351025|Secondary|Difference Between [Change From Week 24 to Week 44] and Change From [Baseline to Week 20] in MCP-1 (log10 Transformed)|"Monocyte chemoattractant protein-1 (MCP-1/CCL2) is one of the key chemokines that regulate migration and infiltration of monocytes/macrophages.~Difference between [change from week 24 to week 44] and change from [baseline to week 20] is defined as [week 44 - week 24] - [week 20 - baseline]."|baseline, week 20, week 24, and week 44|This analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||log10 pg/ml||Inter-Quartile Range|Median
2686342|NCT01351025|Primary|Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in CD8+ T-cell Activation Percent|CD8+ T-cell activation percent (% CD38+/DR+ of CD8+): Difference between [change from week 24 to week 44] and [change from baseline to week 20] (i.e. [week 44 - week 24] - [week 20 - baseline])|baseline, week 20, week 24, and week 44|The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||percent||Inter-Quartile Range|Median
2686343|NCT01351025|Primary|Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in log10 D-dimer|D-dimer in log10 ng/mL: Difference between [change from week 24 to week 44] and [change from baseline to week 20] (i.e. [week 44 - week 24] - [week 20 - baseline])|baseline, week 20, week 24, and week 44|The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||log10 ng/mL||Inter-Quartile Range|Median
2686344|NCT01351025|Primary|Difference Between [Change From Week 24 to Week 44] and [Change From Baseline to Week 20] in CD4+ T-cell Activation Percent|CD4+ T-cell activation percent (% CD38+/DR+ of CD4+): Difference between [change from week 24 to week 44] and [change from baseline to week 20] (i.e. [week 44 - week 24] - [week 20 - baseline])|baseline, week 20, week 24, and week 44|The primary analysis was as-treated, limited to participants who had data for baseline, week 20, week 24, and week 44, and remained on study treatment through week 44 (allowing treatment interruption < 4 weeks), and did not use prohibited medications or have virologic failure during the course of the study.|||percent||Inter-Quartile Range|Median
2686346|NCT01350999|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol|Non-high-density lipoprotein cholesterol was calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
2686350|NCT01350999|Secondary|Percent Change From Baseline in Triglyceride Level||Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52|"Full analysis set (all participants who were randomized and received at least one dose of the investigational product) with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
2686351|NCT01350999|Primary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis||52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.|||participants|||Number
2686352|NCT01350999|Primary|Number of Participants With Clinically Significant Findings in Electrocardiogram After Study Drug Administration|Participants whose results of electrocardiograms were judged as abnormal and clinically significant by investigator after study drug administration were counted in this measure.|52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.|||participants|||Number
2686353|NCT01350999|Primary|Number of Participants With TEAEs Associated With Abnormal Changes in Body Weight||52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.|||participants|||Number
2686354|NCT01350999|Primary|Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs||52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.|||participants|||Number
2686355|NCT01350999|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)||52 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.|||participants|||Number
2686356|NCT01350973|Secondary|Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings After Study Drug Administration||12 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.|||participants|||Number
2686357|NCT01350973|Secondary|Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis||12 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.|||participants|||Number
2686358|NCT01350973|Secondary|Number of Participants With TEAEs Associated With Abnormal Changes in Vital Signs||12 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.|||participants|||Number
2686359|NCT01350973|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs)||12 Weeks|Safety Analysis Set included all participants who received at least one dose of the investigational product.|||participants|||Number
2686360|NCT01350973|Secondary|Percent Change From Baseline in Non-High-Density Lipoprotein - Cholesterol Level Over Time|The percentage change between non-high-density lipoprotein cholesterol collected at each study visit relative to Baseline. Non-high-density lipoprotein cholesterol calculated by subtracting high-density lipoprotein cholesterol from total cholesterol.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
2686361|NCT01350973|Secondary|Percent Change From Baseline in High-Density Lipoprotein - Cholesterol (HDL-C) Level Over Time|The percentage change between high-density lipoprotein cholesterol collected at each study visit relative to Baseline.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
2686362|NCT01350973|Secondary|Percent Change From Baseline in Total Cholesterol Over Time|The percentage change between total cholesterol measured at each study visit relative to Baseline.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
2686363|NCT01350973|Secondary|Percent Change From Baseline in Low-Density Lipoprotein - Cholesterol (LDL-C) Level Over Time|The percentage change between low-density lipoprotein cholesterol collected at each study visit relative to Baseline. Low-density lipoprotein cholesterol particles measured directly by nuclear magnetic resonance.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
2686364|NCT01350973|Secondary|Percent Change From Baseline in Triglyceride Level Over Time|The percentage change between triglycerides collected at each study visit relative to Baseline.|Baseline and Weeks 4, 8, 10 and 12|"Full analysis set with available data at each time point (indicated by n)."|||percent change||Standard Deviation|Mean
2686365|NCT01350973|Primary|Percent Change From Baseline in Triglyceride Level at the Final Visit|The percentage change between triglycerides collected at the end of study drug administration (the end of treatment period or discontinuation) relative to Baseline. Analysis of Covariance (ANCOVA) model was employed, using the Baseline triglyceride level as covariate and the treatment group as an independent variable.|Baseline and 12 weeks|Full analysis set including all participants who were randomized and received at least one dose of the investigational product and with available data.|||percent change||Standard Error|Least Squares Mean
2686366|NCT01350947|Primary|Percentage of Patients With Complete Hematologic Response (According to IWG 2006 Criteria) in CMML Patients Treated With 5-azacitidine.|Complete Hematologic Response is defined as: bone marrow evaluation shows <= 5% myeloblasts with normal maturation of all cells lines; peripheral blood evaluation shows hemoglobin >= 11 g/dL, neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts|24 months||||percentage of patients|||Number
2686367|NCT01350934|Other Pre-specified|Extension Study: Percentage of Participants With Serum 25-Hydroxyvitamin (OH) D <20 ng/mL at Month 12|"The term vitamin D insufficiency is used to describe vitamin D levels that are low enough to cause secondary hyperparathyroidism, bone loss, and increased risk of skeletal fracture. In this study, a threshold for vitamin D insufficiency was a level of serum 25(OH) D <20 ng/mL."|Baseline and Month 12|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for analyses that required baseline data.|||Percentage of Participants|||Number
2686408|NCT01350401|Secondary|Determine the Functional Properties and Phenotype of Modified T-cells From Peripheral Blood and Tumor Sites.|Measurement of functionality of NY-ESO-1ᶜ²⁵⁹T cells in the blood and tumor sites.|8 Weeks post T-cell infusion|Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T with functionality data|||percentage of T cell sub population|T-cell sub population||Number
2686368|NCT01350934|Secondary|Extension Study: Percentage Change From Baseline in s-CTx at Month 12|s-CTx is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. s-CTx was measured at baseline and Month 12.|Baseline and Month 12|Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 12 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.|||Percent change||95% Confidence Interval|Least Squares Mean
2686369|NCT01350934|Secondary|Extension Study: Percentage Change From Baseline in s-P1NP at Month 12|s-P1NP is a biochemical marker of bone turnover that is particularly useful in monitoring bone resorption, a process by which bone is broken down within the body. s-P1NP was measured at baseline and Month 12.|Baseline and Month 12|Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 12 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.|||Percent change||95% Confidence Interval|Least Squares Mean
2686370|NCT01350934|Secondary|Base Study: Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 6|s-CTx is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. s-CTx was measured at baseline and Month 6.|Baseline and Month 6|Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 6 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.|||Percent change||95% Confidence Interval|Least Squares Mean
2686371|NCT01350934|Secondary|Base Study: Percentage Change From Baseline in Serum Procollagen Type 1 N-Terminal Propeptide (s-P1NP) at Month 6|s-P1NP is a biochemical marker of bone turnover that is particularly useful in monitoring bone resorption, a process by which bone is broken down within the body. s-P1NP was measured at baseline and Month 6.|Baseline and Month 6|Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 6 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.|||Percent change||95% Confidence Interval|Least Squares Mean
2686372|NCT01350934|Primary|Extension Study: Percentage Change From Baseline in Lumbar Spine BMD at Month 12|BMD at the lumbar spine was assessed by DXA at baseline and Month 12.|Baseline and Month 12|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for analyses that required baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
2686373|NCT01350934|Primary|Base Study: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 6|BMD at the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) at baseline and Month 6.|Baseline and Month 6|Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for analyses that required baseline data.|||Percent change||95% Confidence Interval|Least Squares Mean
2686374|NCT01350804|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) - Observed Data|Blood samples were obtained to monitor disease activity and response to treatment. A negative change from baseline indicates improvement. The ESR results from baseline up to week 52 were based on observed data, i.e. without imputation.|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||mm/hr||Standard Deviation|Mean
2686375|NCT01350804|Secondary|Change From Baseline in hsCRP - Observed Data|Blood samples were obtained to identify the presence of inflammation, to determine its severity and to monitor response to treatment. A negative change from baseline indicates improvement. The hsCRP results from baseline up to week 52 were based on observed data, i.e. without imputation.|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||mg/L||Standard Deviation|Mean
2686376|NCT01350804|Secondary|Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Observed Data|The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement. The DAS28-CRP results from baseline up to week 52 were based on observed data, i.e. without imputation.|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||score on a scale||Standard Deviation|Mean
2686377|NCT01350804|Secondary|Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Using MMRM|The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.|baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24|Participants from the full analysis set were considered for the analysis. For Placebo and Abatacept participants, data collected after treatment switch was treated as missing, as were missing values for all treatment groups|||score on a scale||Standard Error|Least Squares Mean
2686409|NCT01350401|Secondary|Tumor Response|Number of participants with response as assessed by RECIST (version 1.1) criteria.|Change from Baseline, every 4 weeks until Month 5 and then every other month through Month 11||||Participants|||Count of Participants
2686378|NCT01350804|Secondary|Change From Baseline in HAQ-DI - Observed Data|"The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, are you able to... perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement. The HAQ-DI results from baseline up to week 52 were based on observed data, i.e. without imputation."|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||score on a scale||Standard Deviation|Mean
2686379|NCT01350804|Secondary|Change From Baseline in HAQ-DI - Using Mixed Model Repeated Measures (MMRM)|"The HAQ-DI, assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, are you able to... perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement."|baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24|Participants from the full analysis set were considered for this analysis. For Placebo and Abatacept participants, data collected after treatment switch was treated as missing, as were missing values for all treatment groups.|||score on a scale||Standard Error|Least Squares Mean
2686380|NCT01350804|Secondary|Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Observed Data|ACR20, ACR 50 and ACR 70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20%, 50% and/or 70% improvement, respectively, in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20, ACR50 and ACR70 response results from baseline up to week 52 were based on observed data, i.e. without imputation.|baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||Percentage of participants|||Number
2686381|NCT01350804|Secondary|Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Using Non-responder Imputation|ACR20, ACR 50 and ACR 70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20%, 50% and/or 70% improvement, respectively, in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).|baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24|Participants from the full analysis set were considered for the analysis. Participants with missing data were considered non-responders at the respective time point. Placebo and Abatacept participants were considered non-responders from the time of treatment switch.|||Percentage of participants|||Number
2686382|NCT01350804|Secondary|Percentage of Participants Achieving ACR50|ACR50 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 50% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR50 response results at week 24 used non-responder imputation.|week 24|Full analysis set: the full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||Percentage of participants|||Number
2686383|NCT01350804|Secondary|Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)|"The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, are you able to... perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement."|baseline, week 24|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||score on a scale||Standard Error|Least Squares Mean
2686407|NCT01350401|Secondary|Peak Persistence of Modified T-cells in the Peripheral Blood|Measurement of NY-ESO-1ᶜ²⁵⁹T cells in blood (copies of WPRE per µg of genomic PBMC DNA)|Days 1, 5-9, 12-16, weekly thereafter through Week 12, monthly thereafter through Month 12, and during LTFU|Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T with persistence data|||copies per μg of DNA||Full Range|Mean
2686384|NCT01350804|Secondary|Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP)|The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.|baseline, week 24|Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||score on a scale||Standard Error|Least Squares Mean
2686385|NCT01350804|Primary|Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).|ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire [HAQ-DI] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20 response results at week 24 used non-responder imputation.|week 24|Full analysis set: the full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.|||Percentage of participants|||Number
2686386|NCT01350583|Secondary|Number of Participants With Improvement in Pain Indices|Improvement in pain indices (Memorial Symptom Assessment Scale, MSAS) and Brief Pain Inventory (BPI).|4 weeks per participant|Results data was not tabulated due to low accrual. Outcome Measures were based on 25 evaluable participants. That goal was not reached.||||||
2686387|NCT01350583|Secondary|Percent of Patients Where Treatment Was Well Tolerated|Tolerability and safety of oral sodium bicarbonate in patients with moderate to severe tumor related pain|4 weeks per participant|Results data was not tabulated due to low accrual. Outcome Measures were based on 25 evaluable participants. That goal was not reached.||||||
2686388|NCT01350583|Primary|Percent of Patients With Improvement|Percent of patients with greater than 30% improvement in pain intensity by visual assessment scale.|4 weeks per participant|Results data was not calculated due to low accrual. Outcome Measures were based on 25 evaluable participants. That goal was not reached.||||||
2686389|NCT01350544|Primary|Medication Adherence|We used a repeated measures linear regression modeling continuous adherence with intervention, linear time, and their interaction, and demographic covariates. Continuous adherence is measured as average percentages of doses taken.|Baseline, 1.5 months, 3 months, 4.5 months, and 6 months||||Percentage of doses taken||Standard Deviation|Mean
2686390|NCT01350505|Primary|Change in Balance|Balance was assessed during a 13-minute nocturnal light exposure (4 different conditions) and differences between the conditions were assessed. To determine goodness of balance while walking, the variability in stride length (i.e., variance in stride-to-stride length) was calculated in each of the conditions. Increased variability in stride length is associated with increased risk of falling.|13 minutes|Healthy older adults. Note 4 participants declined to participate in the last condition (white room light).|||%CV||Standard Deviation|Mean
2686391|NCT01350479|Primary|MRSA Transmission|Presence of MRSA on gown or gloves worn by enrolled health care worker for research purposes while providing a specific type of care for enrolled resident|Will be measured during 6-25 episodes of care interactions scheduled over the 30 days following resident enrollment|We analyzed the number of gown and glove swabs from HCW interacting with MRSA and non-MRSA colonized residents.|||Proportion of swabs positive for MRSA|swabs||Number
2686392|NCT01350453|Secondary|Change in Occupational Performance: Canadian Occupational Performance Measure Performance (COPM)|The Canadian Occupational Performance Measure (COPM) is an individualized client-centered measure designed for use by therapists to detect a change in a client's self-perception of occupational performance over time. The COPM involves a 5-step process within a semi-structured interview conducted by a therapist. The Interview focuses on identifying activities within each performance domain that the client wants, needs, or is expected to perform. They are then asked to rate their performance and satisfaction from 0-10 for each activity identified. A score of 0 indicates they are unable to perform the activity and a score of 10 means they can complete the activity. The same scoring system is used for the COPM Satisfaction assessment with scores ranging from 0-10 and higher scores indicating greater satisfaction.|Baseline, Post intervention (three weeks) and 6 months||||units on a scale||Standard Deviation|Mean
2686393|NCT01350453|Secondary|Change in Upper Limb Impairment: Fugel Myer Upper Extremity (FMUE)|"The upper extremity domain of the Fugel Myer is a 0-66 point clinical assessed scale where separate Items are scored on a 3-point ordinal scale:~0 = cannot perform, 1 = performs partially, 2 = performs fully. A higher score indicates indicates an increased level of function."|Baseline, Post Intervention (three weeks) and 6 months||||units on a scale||Standard Deviation|Mean
2686394|NCT01350453|Secondary|Change in Upper Limb Function: Wolf Motor Function Test (WMFT) Functional Ability Scale (FAS)|The modified WMFT is a valid, widely used measure that scores performance of activities of daily living in a controlled and structured environment he test has 17 items which test a range of functional upper limb tasks (for example turning a key in a lock, folding a towel, retrieving a weight). Each item is scored by the time taken to complete the task, the weight lifted or hand strength as measured by a hand held goniometer. Each item is subsequently scored on a rating scale 'The Functional Ability Scale' (FAS) from 0-5. Zero is scored if the participant does not attempt the task with their hemiplegic arm, and five is scored if the task is completed with a normal movement. The mean score of all items results with a mean FAS score.|Baseline, Post intervention (three weeks), 6 months||||units on a scale||Standard Deviation|Mean
2686395|NCT01350453|Primary|Change From Baseline in Upper Limb Impairment: Motor Activity Log (MAL) Quality of Use (QOU)|he MAL comprises 28 functional items, (e.g. picking up a glass; turning a key to open the door) each item is assessed by self-report on a six-point ordinal scale (0-5). Participants are asked to rate the quality of use of their hemiplegic arm for each item. Zero is scored if they can not use their affected arm, five is scored when they can use their affected arm as well as before their stroke occurred. The final MAL score is calculated as a mean score of the individual items. The minimum and maximum mean scores are 0-5, with higher values representing better outcomes.|Baseline, Post Intervention (three weeks) and 6 months||||units on a scale||Standard Deviation|Mean
2686396|NCT01350453|Primary|Change in Upper Limb Impairment: Motor Activity Log (MAL) Amount of Use (AOU)|The MAL comprises 28 functional items, (e.g. picking up a glass; turning a key to open the door) each item is assessed by self-report on a six-point ordinal scale (0-5). Participants are asked to rate the amount of use of their hemiplegic arm for each item. Zero is scored if they have not used their affected arm, five is scored when they use their affected as often as before their stroke occurred. The final MAL score is calculated as a mean score of the individual items. The minimum and maximum mean scores are 0-5, with higher values representing better outcomes.|Baseline, Post intervention (three weeks) and 6 months||||units on a scale||Standard Deviation|Mean
2686397|NCT01350414|Secondary|Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|Post-Bronchodilator FEV1 (% Predicted) percentage changes from Baseline to the Year 1, Year 2, Year 3, Year 4, and Year 5.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Percentage of change from Baseline||Standard Deviation|Mean
2686398|NCT01350414|Secondary|Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)|Pre-Bronchodilator FEV1 (% Predicted) percentage changes from Baseline to the Year 1, Year 2, Year 3, Year 4, and Year 5.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Percentage of change from Baseline||Standard Deviation|Mean
2686399|NCT01350414|Secondary|Hospitalizations for Respiratory Symptoms|Number of Hospitalizations for Respiratory Symptoms per subject per year.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Number of events/subjects/year||95% Confidence Interval|Number
2686400|NCT01350414|Secondary|Hospitalizations for Respiratory Symptoms|Proportion of subjects with hospitalizations for respiratory symptoms.|12 Month periods out to 5 Years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Percentage of subjects hospitalized||95% Confidence Interval|Number
2686401|NCT01350414|Secondary|Emergency Room (ER) Visits for Respiratory Symptoms|Number of Emergency Room Visits for Respiratory Symptoms per subject per year.|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Number of events/subject/year||95% Confidence Interval|Number
2686402|NCT01350414|Secondary|Emergency Room Visits for Respiratory Symptoms|Proportion of Subjects with Emergency Room Visits for Respiratory Symptoms|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Percentage subjects ER respir. symptoms||95% Confidence Interval|Number
2686403|NCT01350414|Secondary|Respiratory Adverse Events|"Proportion of subjects experiencing one or more respiratory adverse event in each of the years 1 through 5 following the Alair treatment. A respiratory adverse event is defined as any sign, symptom, illness, clinically significant abnormal laboratory value, or other adverse medical event associated with the Respiratory System that appears or worsens in a subject during a clinical study, regardless of whether or not it is considered related to the procedure used as part of the protocol."|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Percentage subjects with respiratory AE||95% Confidence Interval|Number
2686404|NCT01350414|Secondary|Respiratory Adverse Events|"Number of respiratory adverse events per subject per year. A respiratory adverse event is defined as any sign, symptom, illness, clinically significant abnormal laboratory value, or other adverse medical event associated with the Respiratory System that appears or worsens in a subject during a clinical study, regardless of whether or not it is considered related to the procedure used as part of the protocol."|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Number of events/number of subject/Year||95% Confidence Interval|Number
2686405|NCT01350414|Secondary|Severe Exacerbations|Number of severe exacerbations per subject per year. Severe exacerbation is defined as treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a subject taking maintenance oral corticosteroids at entry into the AIR2 Trial (Protocol #04-02).|12 Month periods out to 5 years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Number of events/Number of subjects/Year||95% Confidence Interval|Number
2686406|NCT01350414|Primary|Severe Exacerbations|"The primary endpoint will be the proportion of subjects experiencing severe exacerbations during the first year after the Alair treatment compared to subsequent 12-month periods out to 5 years. This objective will be met if the upper 95% confidence limit of the difference in proportions (i.e., the subsequent 12-month proportion minus the first 12-month proportion) is less than 20%.~Severe exacerbation is defined as treatment with oral or intravenous corticosteroids, OR a doubling of the baseline inhaled corticosteroid dose for at least 3 days, OR any temporary increase in the dosage of oral corticosteroids for a subject taking maintenance oral corticosteroids at entry into the AIR2 Trial (Protocol #04-02)."|12 month periods out to 5 Years|Number of Subjects Completing Follow-up. 181 subjects completed 12 month follow-up; 165 subjects completed Year 2 follow-up; 162 subjects completed Year 3 follow-up; 159 subjects completed Year 4 follow-up; and 162 subjects completed Year 5 follow-up.|||Percentage subjects severe exacerbations||95% Confidence Interval|Number
2686410|NCT01350401|Primary|Adverse Events Related to Study Treatment|Number of Participants with NCI CTC V.4 Adverse Events related to study treatment greater than or equal to Grade 3|Up to 12 months|Participants who received cytoreductive chemotherapy followed by IV infusion of NY-ESO-1ᶜ²⁵⁹T|||Participants|||Count of Participants
2686411|NCT01350388|Secondary|Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 24 Weeks|The percent difference in plasma hsCRP concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks||||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
2686412|NCT01350388|Secondary|Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 24 Weeks|The percent difference in plasma IL-6 concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks||||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
2686413|NCT01350388|Secondary|Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 24 Weeks|The percent difference in plasma TNF-α concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks||||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
2686414|NCT01350388|Primary|Change in Urinary Concentrations of Transforming Growth Factor-beta1 (TGF-beta1) From Baseline to 24 Weeks|The percent difference in TGF-beta1 concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks||||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
2686415|NCT01350388|Primary|Change in Adiponectin Concentration in Adipose Tissue From Baseline to 24 Weeks|The percent difference in adiponectin concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks||||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
2686416|NCT01350388|Primary|Change in Thiobarbituric Acid Reactive Substance (TBARS) Concentration in Adipose Tissue From Baseline to 24 Weeks|The percent difference in thiobarbituric acid reactive substance (TBARS) concentration geometric mean values from baseline to 24 weeks was calculated for each arm|Baseline and 24 weeks||||percent difference in geometric mean||95% Confidence Interval|Geometric Mean
2686417|NCT01350271|Secondary|Faecal Egg Count Reduction 2 (FECR2)|FECR2=〈Arithmetic mean {[(pretreatment egg count)-(posttreatment egg count)]÷(pretreatment egg count)}〉×100|Two weeks|All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow up were included in the analysis|||percentage of eggs excreted||Standard Deviation|Mean
2686418|NCT01350271|Secondary|Faecal Egg Count Reduction 1 (FECR1)|FECR1= {[(Arithmetic mean of pretreatment egg counts)-(arithmetic mean of posttreatment egg counts)]÷(arithmetic mean of pretreatment egg counts)}×100|Two weeks|All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow-up, were included in the analysis|||percentage of eggs excreted|||Number
2686419|NCT01350271|Primary|Cure Rate|Cure rate={(Number positive pretreatment - Number positive posttreatment)÷(Number positive pretreatment)}×100|Two weeks|All participants who were hookworm positive at baseline, and who provided a faecal sample for examination at follow up.|||percentage of participants|||Number
2686420|NCT01350258|Secondary|Overall Survival|To assess overall survival in patients undergoing HSCT treated on this trial.|At 1 and 3 years|||||||
2686421|NCT01350258|Secondary|Engraftment Rate and Lymphoid Reconstitution|To evaluate engraftment rates and lymphoid reconstitution in patients treated on this trial.|100 days post-transplant|||||||
2686422|NCT01350258|Secondary|GVHD Incidence and Severity|To determine the incidence and severity of graft-versus-host disease (GVHD) in patients undergoing treatment on this regimen using MEL for T cell tolerization as well as tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis.|At 1 and 3 years|||||||
2686423|NCT01350258|Secondary|Relapse Rate|To compare relapse rates in patients undergoing HSCT treated on this successor TJU 2 Step RIC haploidentical regimen and compare it with that of the initial regimen.|At 1 and 3 years|||||||
2686424|NCT01350258|Primary|Phase 2: Non-Relapse Mortality (NRM)|To evaluate the 100 day non-relapse mortality (NRM) rate in patients undergoing HSCT treated on this successor TJU 2 Step RIC haploidentical regimen and compare it with that of the initial regimen.|100 days post-treatment|||||||
2686425|NCT01350258|Primary|Phase 1: Defined Dose of Melphalan (MEL)|To define the dose of MEL required for the establishment of peripheral T cell tolerance with concomitant immune reconstitution.|100 days post-transplant|||||||
2686426|NCT01350245|Primary|Probability of Overall Survival at 15 Months Post-treatment|Probability of overall survival at 15 months post-treatment, defined as success if a patient is alive 1-year post-transplant.|15 months||||percentage of probability|||Number
2686427|NCT01350245|Primary|Disease-Free Survival (DFS)|1-year post-transplant disease free survival (DFS), defined as success if a patient is alive and disease free at 1-year post-transplant.|1 year post-transplant||||percentage of patients|||Number
2686428|NCT01350232|Secondary|Cytokine Profile|To characterize the profiles of cytokines released following administration of the lymphoid portion of the transplant (donor lymphocyte infusion [DLI]).|Through 5 years after infusion|||||||
2686429|NCT01350232|Secondary|Quality of Life|To describe the quality of life and functional status following transplantation.|Through 5 years post infusion|||||||
2686430|NCT01350232|Secondary|Immune Recovery|To assess the pace of lymphoid recovery and associated risk for opportunistic infections and relapse (return to recipient erythropoiesis) in this patient population.|100 days post infusion through 5 years post infusion|||||||
2686431|NCT01350232|Secondary|Correction of Hemoglobinopathy|To evaluate the extent of correction of hemoglobinopathy following this reduced intensity transplant.|100 days post infusion through 5 years post infusion|||||||
2686432|NCT01350232|Secondary|Acute Graft Versus Host Disease|To describe the incidence and severity of acute and chronic GVHD following this reduced intensity transplant from partially matched related donors using a combination of cyclophosphamide, tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis.|100 days post infusion|||||||
2686433|NCT01350232|Secondary|Overall Survival|To determine the overall survival at 6 months post-transplant in patients receiving a matched or partially-matched related donor transplant after reduced-intensity conditioning.|6 months post infusion|||||||
2703738|NCT01216631|Secondary|US Synovitis Score|Change in US synovitis score of the affected knee at 2 and 8 weeks after treatment initiation|2 weeks|||||||
2686435|NCT01350232|Primary|Stable Engraftment|To determine if the reduced intensity preparative regimen of fludarabine, cytarabine, cyclophosphamide and low-dose total body irradiation will generate stable engraftment with donor hematopoietic stem cells in at least 80% of patients with severe sickle cell anemia.|180 days post-infusion|||||||
2686436|NCT01350141|Secondary|Number of Participants With Anti-drug (Anti-PF-04950615) Antibody (ADA)|Human serum samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA). Results with titer value >=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure.|Day 1 up to Day 141|Analysis set included all participants who received at least 1 dose of PF-04950615 (RN316).|||participants|||Number
2686437|NCT01350141|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters|Number of participants with clinically significant changes in vital signs and ECG findings were reported. Criteria for clinical significant vital signs: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (>=) 30 millimeter of mercury (mmHg), maximum increase or decrease from baseline in supine diastolic BP of >=20 mmHg. Criteria for clinically significant ECG parameters: maximum increase of >=25 percent (%) for baseline value of greater than 200 millisecond (msec) or maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec for PR and QRS interval, maximum increase from baseline of greater than (>) 30 to <=60 msec and maximum increase from baseline of >60 msec for QT interval corrected using the Fridericia's formula (QTCF). Screening was 21 days prior to start of study treatment.|Screening up to Day 141|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2686438|NCT01350141|Secondary|Number of Participants With Clinically Significant Laboratory Abnormalities|Criteria for clinically significant laboratory abnormalities were based on investigator's discretion. Total number of participants who met the criteria for any laboratory abnormal findings were reported. Laboratory parameters included: hematology, coagulation, liver function, renal function, electrolytes, hormones, chemistry and urinalysis. Screening was 21 days prior to start of study treatment.|Screening up to Day 141|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2686439|NCT01350141|Secondary|Number of Treatment-Emergent Adverse Events (TEAEs) by Severity|An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Investigator assessed adverse events as mild (does not interfere with participant's usual function), moderate (interferes to some extent with participant's usual function) or severe (interferes significantly with participant's usual function). All causality TEAEs were assessed for severity. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state.|Day 1 up to Day 141|Safety analysis set included all participants who received at least 1 dose of study medication.|||Treatment-emergent AEs|||Number
2686440|NCT01350141|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. Treatment related: a TEAE deemed related to the study drug by the investigator. TEAEs included SAEs (TESAEs) as well as non-serious AEs which occurred during the study. The participants with TEAEs, TESAEs and treatment-related TEAEs were reported.|Day 1 up to Day 141|Safety analysis set included all participants who received at least 1 dose of study medication.|||Participants|||Count of Participants
2686441|NCT01350141|Secondary|Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85|Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 29, 57, 85|"Efficacy analysis set. Number of participants analyzed = participants who were evaluable for this measure at given time points for each arm. Results for percent change at Day 85 for ApoB and ApoA1 were not reported as data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol."|||percent change||Standard Deviation|Mean
2686442|NCT01350141|Secondary|Change From Baseline in Lipid Parameters at Day 29, 57 and 85|Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 29, 57, 85|Efficacy analysis set. 'Number of participants analyzed' = participants who were evaluable for this measure at given time points for each arm. Results for change at Day 85 for ApoB and ApoA1 were not reported as data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol.|||mg/dL||Standard Deviation|Mean
2686443|NCT01350141|Secondary|Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)||Day 29, 57, 85|"Efficacy analysis set. Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and Number of Participants Analyzed signifies those participants who were evaluable for this measure at given time points, for each group respectively."|||percentage of participants|||Number
2686444|NCT01350141|Secondary|Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than 70 and Less Than 100 Milligram Per Deciliter (mg/dL)||Day 29, 57, 85|"Efficacy analysis set. Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure and Number of participants analyzed signifies those participants who were evaluable for this measure at given time points, for each group respectively."|||Percentage of participants|||Number
2688186|NCT01335750|Secondary|Subjective Comfort|Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)|Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours|Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)|||units on a scale||Standard Deviation|Mean
2686445|NCT01350141|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85|Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 85|"Efficacy analysis set included all participants who received at least 1 dose of study medication and completed the Day 85 visit or dropped out prematurely, whichever was earlier. Overall number of participants analyzed signifies those participants who were evaluable for this outcome measure."|||percent change||Standard Deviation|Mean
2686446|NCT01350128|Secondary|Change From Baseline in 12-hour Post-dose Trough FEV1 on Day 7|Change from baseline in 12-hour post-dose trough FEV1|Day 7|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.|||Liters||95% Confidence Interval|Least Squares Mean
2686447|NCT01350128|Secondary|Peak Change From Baseline in IC on Day 7|Peak change from baseline in IC|Day 7|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.|||Liters||95% Confidence Interval|Least Squares Mean
2686448|NCT01350128|Secondary|Peak Change From Baseline in FEV1 on Day 7|Peak change from baseline in FEV1|Day 7|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.|||Liter||95% Confidence Interval|Least Squares Mean
2686449|NCT01350128|Secondary|Change From Baseline in Morning Pre-dose FEV1 on Day 7|Change from baseline in morning pre-dose FEV1|Day 7|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.|||Liter||95% Confidence Interval|Least Squares Mean
2686450|NCT01350128|Secondary|Peak Change From Baseline in IC on Day 1|Peak change from baseline in Inspiratory Capacity (IC) on Day 1 (mean of 1 and 2 hours post-dose minus baseline on Day 1)|Day 1|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.|||Liter||95% Confidence Interval|Least Squares Mean
2686451|NCT01350128|Secondary|Proportion of Subjects Achieving at Least 12% Improvement in FEV1 on Day 1|Proportion of subjects achieving at least 12% improvement in FEV1 (relative to baseline)|Day 1|MITT Population: This includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.|||Percent|||Number
2686452|NCT01350128|Secondary|Time to Onset of Action ( ≥10% Improvement in FEV1) on Day 1|Time to onset of action ( ≥10% improvement in FEV1)|Day 1 (15 min, 30 min, 1 hour, 2 hours)|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.|||% of subjects|||Number
2686453|NCT01350128|Secondary|Peak Change From Baseline in FEV1 on Day 1|Highest value of FEV1 post-dose minus baseline on Day 1 (baseline-adjusted)|Day 1|MITT Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.|||Liter||95% Confidence Interval|Least Squares Mean
2686454|NCT01350128|Primary|FEV1 AUC0-12|FEV1 AUC0-12 following chronic dosing (1 week), normalized.|Day 7 ( -1 hour, -30 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5.5 hours, 6.5 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours)|Modified Intent to Treat (MITT) Population includes subjects who completed at least 2 treatment periods, with minimally 1 pre-dose assessment on Day 7 for each of those 2 treatment periods with no protocol deviations believed to have a potential impact on efficacy results.|||Liter||95% Confidence Interval|Least Squares Mean
2686455|NCT01350115|Secondary|Measure: Disease Burden by BCC Tumor Counts|BCC tumor counts were performed separately for five body regions: head and neck, trunk back, trunk front (including axillae and groin), upper extremities and lower extremities (including buttocks). During the counting, the BCC tumors, were categorized upon inspection by their longest diameter measurement (<10 mm, 10-19 mm, 20-29 mm, and >+30mm), and also by the type of BCC (superficial, nodular, other). The counts for all of the BCC type and size categories were determined (or estimated if many small lesions) for each body region. The body region counts were summated to provide the overall BCC tumor count.|Baseline, day 85, and day 113|All participants, who had evaluable (or complete) pharmacodynamic (PD) or biomarker parameter data and were without protocol deviations with significant impact on the PD data, were included in the PD analysis set.|||Number of BCC tumors|||Number
2686456|NCT01350115|Secondary|Histological Clearance Assessment of Main Target BCCs|The main (and secondary, if appropriate) target BCC tumor area(s) was/were excised surgically and sent to a central laboratory for histological examination.|day 113|All participants, who had evaluable (or complete) pharmacodynamic (PD) or biomarker parameter data and were without protocol deviations with significant impact on the PD data, were included in the PD analysis set.|||Percentage of participants|||Number
2686457|NCT01350115|Primary|Clinical Clearance Assessment of Main Target Basal Cell Carcinomas (BCCs)|The clinical response of the main target (and secondary target, as appropriate) BCC(s) to treatment was evaluated using the following 6-point scale comparing the assessment at the visit to the clinical presentation at Baseline: 0 = Worsening, 1 = No change, 2 = Slight clearance (1-25% improvement), 3 = Moderate clearance (26-75% improvement), 4 = Marked clearance (76-99% improvement),5 = Complete clearance (100% improvement) Complete clearance was defined as no clinical residual signs of carcinoma, as evaluated by the Investigator at a post-Baseline visit, with the exception of post-inflammatory changes such as minimal residual erythema or residual hyper-pigmentation or hypo-pigmentation or residual scarring.|Day 113|All participants, who had evaluable (or complete) pharmacodynamic (PD) or biomarker parameter data and were without protocol deviations with significant impact on the PD data, were included in the PD analysis set.|||Participants|||Number
2687075|NCT01345162|Secondary|Number of Participants With Adverse Events as a Measure of Safety and Tolerability|"All adverse events (eg: PONV (postoperative nausea and vomiting), itching, dizziness, epigastralgia) are recorded.~Assessment of any difference between the two groups."|4 days postherniotoy|||||||
2686458|NCT01350102|Secondary|Wound Area Measurements|Wound area measurements in length, width, and depth throughout the course of the study(measured in cm).|Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months|The subject enrolled in Bacitracin with Vit C arm had measurements of the wound (width, depth, length) recorded beginning at week 0 through week 20. The subject enrolled in the AmeriGel wound care dressing alone had measurements recorded of the wound (width, depth, length) beginning at week 0 through week 2 before withdrawing from the study.|||cm|||Number
2686459|NCT01350102|Secondary|Length of Time for Wound Closure|Length of time for wound closure will be measured in days|Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months|Only the subject in the Bacitracin with Vit C arm achieved would healing. The subject in the AmeriGel would care dressing alone arm was withdrawn due to lack of healing and infection.|||Days|||Number
2686460|NCT01350102|Primary|Hgb A1c Level|Hgb A1c measures the average blood glucose over three months (% of hemoglobin). All subjects will be asked to get their hemoglobin A1c level at the beginning of the study and every three months for as long as they participate in the study.|Patients are assessed every 3 months from enrollment through end of study participation, which may be 6 months|"Enrollment and 3-month visit A1c levels were obtained for the subject in the Bacitracin with Vit C arm. Enrollment A1c level was obtained for the AmeriGel would care dressing alone.~However, this subject withdrew from the study before 3-month A1c level was obtained."|||percentage of hemoglobin|||Number
2686461|NCT01349972|Secondary|Progression-free Survival|Probabilities will be estimated with the Kaplan-Meier estimate. Survival estimates at two years will be estimated.|4 years||||years||95% Confidence Interval|Median
2686462|NCT01349972|Secondary|Number of Patients With Minimal Residual Disease|Comparisons of the treatments with respect to MRD will be based on the number of patients with MRD at day 14 after the start of treatment.|From study start to 14 days after the start of treatment||||Participants|||Count of Participants
2686463|NCT01349972|Secondary|Overall Survival|Probabilities will be estimated with the Kaplan-Meier estimate. Survival estimates at two years will be estimated.|4 years||||years||95% Confidence Interval|Median
2686464|NCT01349972|Secondary|Disease-free Survival|Probabilities will be estimated with the Kaplan-Meier estimate. Survival estimates at two years will be estimated. Disease-free survival Overall survival was defined from date of randomization to death or last known follow-up. Event free survival was defined as date of randomization to the first occurrence of persistent AML after 1 cycle of induction, relapse or death. Patients were censored for event free survival if they had received non-protocol therapy or a stem cell transplant.|Time from randomization until death from any cause or relapse or recurrence, assessed up to 2 years||||years||Full Range|Median
2686465|NCT01349972|Secondary|Incidence of Toxicities, Characterized by Number of Events by Treatment and Grade|The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting.|Up to 14 days after completion of study treatment|Number of evaluable subjects|||Number of events|||Number
2686466|NCT01349972|Primary|Complete Response Rate|Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/cu mm and a platelet count of 100,000/cu mm, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, clearance of disease-associated cytogenetic abnormalities, and clearance of any previously existing extramedullary disease. These criteria are taken from Dohner H, Estey EH, Amadori S, et al. Diagnosis and management of acute myeloid leukemia in adults: recommendations from an international expert panel, on behalf of the European LeukemiaNet. Blood 2010;115:453-474|3 years||||participants|||Number
2686467|NCT01349959|Other Pre-specified|Number of Participants With Change in Gene Methylation Evaluated Using Quantitative Multiple Methylation-specific Polymerase Chain Reaction (QM-MSP)||Up to 8 weeks|There were 13/40 participants with triple-negative breast cancer (TNBC) and 27/40 participants with hormone-resistant breast cancer (HRBC).|||Participants|||Count of Participants
2686468|NCT01349959|Other Pre-specified|Feasibility of the Addition of Hormone Therapy, Evaluated by Calculating the Number of Patients With Disease Progression That go on to Receive Hormonal Therapy||Up to 3 years|There were 13/40 participants with triple-negative breast cancer (TNBC) and 27/40 participants with hormone-resistant breast cancer (HRBC).|||Participants|||Count of Participants
2686469|NCT01349959|Other Pre-specified|Confirmed Response Rate to Azacitidine and Entinostat Plus the Addition of Hormone Therapy|Will be estimated in each cohort. All evaluable patients who receive hormonal therapy will be used for this analysis.|Up to 3 years|There were 13/40 participants with triple-negative breast cancer (TNBC) and 27/40 participants with hormone-resistant breast cancer (HRBC).|||Participants|||Count of Participants
2686470|NCT01349959|Other Pre-specified|Circulating DNA Evaluated Using QM-MSP|Data will also be graphically displayed showing trend in median values across time. Nonparametric Wilcoxon signed rank tests will be used to determine whether or not the data shows evidence of changes from baseline.|Up to 8 weeks|||||||
2686471|NCT01349959|Other Pre-specified|Number of Participants With Change in Expression of Relevant Genes (e.g., ER Alpha and RAR Beta) Evaluated by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)|Number of participants with a change in candidate gene re-expression of ER-alpha and RAR beta evaluated by reverse transcriptase polymerase chain reaction (RT-PCR).|Baseline to up to 8 weeks|There were 13/40 participants with triple-negative breast cancer (TNBC) and 27/40 participants with hormone-resistant breast cancer (HRBC). However, data was only evaluable in 19/40 participants (5/13 TNBC, and 14/40 HRBC).|||Participants|||Count of Participants
2686472|NCT01349959|Secondary|Progression-free Survival (PFS)|Median number of months without progression. Estimated using the method of Kaplan-Meier.|6 months|There were 13/40 participants with triple-negative breast cancer (TNBC) and 27/40 participants with hormone-resistant breast cancer (HRBC).|||months||95% Confidence Interval|Median
2686473|NCT01349959|Secondary|Overall Survival|Median number of months alive, estimated by Kaplan-Meier method.|Up to 3 years|There were 13/40 participants with triple-negative breast cancer (TNBC) and 27/40 participants with hormone-resistant breast cancer (HRBC).|||months||95% Confidence Interval|Median
2687169|NCT01344356|Primary|Local Recurrence|Instances of progressive disease|5 years|12 patients did not have local recurrence rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected.|||Participants|||Count of Participants
2686474|NCT01349959|Secondary|Clinical Benefit Rate|Clinical benefit rate estimated by the number of patients who achieve a confirmed response plus the number of patients who have stable disease for a duration of at least 6 months divided by the total number of evaluable patients. All evaluable patients will be used for this analysis.|Up to 3 years|There were 13/40 participants with triple-negative breast cancer (TNBC) and 27/40 participants with hormone-resistant breast cancer (HRBC).|||Participants|||Count of Participants
2686475|NCT01349959|Primary|Confirmed Response Rate (Percentage of Participants With Complete or Partial Response Noted as the Objective Status on Two Consecutive Evaluations at Least 4 Weeks Apart) Assessed by RECIST|Percentage of participants with complete or partial response will be estimated independently for each cohort by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.|Up to 3 years|There were 13/40 participants with triple-negative breast cancer (TNBC) and 27/40 participants with hormone-resistant breast cancer (HRBC).|||percentage of participants||95% Confidence Interval|Number
2686476|NCT01349933|Secondary|Duration of Response|Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented.|The date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years|Analysis not conducted due to having too few patients with evaluable for this endpoint.||||||
2686477|NCT01349933|Secondary|Best Response (Complete Response vs Partial Response vs Stable Disease vs Progression)|Evaluated using RECIST version 1.1. A Complete Response (CR) requires disappearance of all target lesions and each target lymph node must have reduction in short axis to <1.0 cm. A Partial Response (PR) requires at least a 30% decrease in the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation. Progressive Disease (PD) is defined as either a new lesion of a 20% increase in the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes. Stable Disease (SD) is defined as not having a PD, CR, or PR.|Up to 3 years|All patients who began protocol treatment were included in this analysis.|||Participants|||Count of Participants
2686478|NCT01349933|Secondary|Progression-free Survival|Progression-free survival is defined as the time from registration to the time of progression or death, whichever occurs first. Estimated using the method of Kaplan-Meier.|From registration to the first of either death due to any cause or progression, assessed up to 3 years|All patients who began protocol treatment were included in this analysis.|||months||95% Confidence Interval|Median
2686479|NCT01349933|Secondary|Overall Survival|Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 3 years|All patients that started protocol therapy were included in this analysis.|||months||95% Confidence Interval|Median
2686480|NCT01349933|Secondary|Adverse Events Associated With the Agent Graded Based on CTCAE Version 4.0|The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. Only the severe or worse adverse events will be assessed, regardless of relationship to the study treatment. The number of patients reporting a grade 3 or higher event were counted.|Up to 30 days after completion of study treatment|All patients that began protocol treatment were included in this analysis.|||Participants|||Count of Participants
2686481|NCT01349933|Primary|Confirmed Response Rate Defined to be a CR or PR Noted as the Objective Status on 2 Consecutive Evaluations at Least 4 Weeks Apart|Evaluated using RECIST version 1.1. A Complete Response (CR) requires disappearance of all target lesions and each target lymph node must have reduction in short axis to <1.0 cm. A Partial Response (PR) requires at least a 30% decrease in the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.|6 months||||percentage of participants|||Number
2686482|NCT01349933|Primary|Proportion of Patients Alive and Progression-free|The primary endpoint of this trial is the proportion of patients alive and progression-free at 6 months. Progression status is evaluated using RECIST version 1.1. A Progression is defined as either: At least one new malignant lesion, which also includes any lymph node that was normal at baseline (less than 1.0 cm short axis) and increased to greater than or equal to 1 cm short axis during follow up. Or, at least a 20% increase in sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes.|6 months||||participants|||Number
2686483|NCT01349920|Secondary|Concordance Correlation Coefficient for Comparison Between Central Endoscopic Evaluation and Site Endoscopic Evaluation|The CCC of blinded (central) versus unblinded (site) scores from either CDEIS or the Simple Endoscopic Score for Crohn's Disease (SES-CD) was determined at Baseline, Week 6 and Week 22. SES-CD sums the following scores: presence and size of ulcers in five visualized bowel segments; extent of ulcerated surface in five visualized bowel segments; extent of affected surface in five visualized bowel segments; presence and type of narrowings in five visualized bowel segments; and can range from 0-56, with a higher sum indicating greater severity of mucosal inflammation. The CCC can range from 0 to 1 with higher values indicating greater concordance between the 2 measurements.|Baseline, Week 6, Week 22|Participants who had both blinded and unblinded scores available for analysis.|||Correlation coefficient||90% Confidence Interval|Number
2686484|NCT01349920|Secondary|Concordance Correlation Coefficient for Comparison of Repeat Baseline Measurements of Biochemical Biomarkers|Based on two measurements at baseline, the concordance correlation coefficient (CCC) was computed for each of four biomarkers, using a mixed effects model with a fixed factor for repeat measurements and a random factor for participant. The CCC can range from 0 to 1 with higher values indicating greater concordance between the 2 measurements.|Baseline Visit 1 (one week prior to dosing), Baseline Visit 2 (1-2 days prior to dosing)|Participants who had both baseline serum or stool measurements available for analysis.|||Correlation coefficient||90% Confidence Interval|Number
2686526|NCT01349816|Primary|FEV1 AUC0-12|Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week).|Day 7|Modified Intent to Treat (MITT) Population is made of participants who completed both treatment periods and had Pre-dose Day 1 data for both and no protocol deviations believed to have a potential impact on efficacy results. Subjects must have had data for the given endpoint to be included.|||Liters||95% Confidence Interval|Least Squares Mean
2686485|NCT01349920|Primary|Coefficient of Determination (R^2) For Predicting The Change From Baseline In Blinded CDEIS Score From The Changes From Baseline In Four Biomarkers At Weeks 6 and 22|To determine R^2 a multiple linear regression analysis was conducted with the change from baseline in CDEIS score as the response variable and the baseline CDEIS score, changes from baseline in the four biomarkers serum hsCRP, serum lipocalin-2, serum Reg3-A, and stool calprotectin (their concentrations were log-transformed to make the mean function of the response more linear) at Weeks 6 and 22 as the predictor variables. CDEIS scores were provided by a blinded observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy. The R^2 can range from 0 to 1; with higher values indicating greater predictability of the model. The primary hypothesis is that the true R^2 at weeks 6 and 22 is approximately 0.7.|Baseline and Week 6 or 22|Participants who had a blinded CDEIS score and measurements for each of the biomarkers included in the models at both baseline and at Week 6 or 22.|||Coefficient of Determination|||Number
2686486|NCT01349920|Primary|Change From Baseline in REG3-A at Week 22|Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.|Baseline and Week 22|Participants with measurements for REG3-A at both baseline and at Week 22.|||ng/mL||Standard Deviation|Mean
2686487|NCT01349920|Primary|Change From Baseline in Regenerating Islet-Derived 3-Alpha (REG3-A) at Week 6|Concentrations of the serum biomarker REG3-A were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.|Baseline and Week 6|Participants with measurements for REG3-A at both baseline and at Week 6.|||ng/mL||Standard Deviation|Mean
2686488|NCT01349920|Primary|Change From Baseline in Serum Lipocalin-2 at Week 22|Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.|Baseline and Week 22|Participants with measurements for lipocalin-2 at both baseline and at Week 22.|||ng/mL||Standard Deviation|Mean
2686489|NCT01349920|Primary|Change From Baseline in Serum Lipocalin-2 at Week 6|Concentrations of the serum biomarker lipocalin-2 were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.|Baseline and Week 6|Participants with measurements for lipocalin-2 at both baseline and at Week 6.|||ng/mL||Standard Deviation|Mean
2686490|NCT01349920|Primary|Change From Baseline in Stool Calprotectin at Week 22|Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.|Baseline and Week 22|Participants with measurements for calprotectin at both baseline and at Week 22.|||µg/g||Standard Deviation|Mean
2686491|NCT01349920|Primary|Change From Baseline in Stool Calprotectin at Week 6|Concentrations of the stool biomarker calprotectin were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.|Baseline and Week 6|Participants with measurements for calprotectin at both baseline and at Week 6.|||µg/g||Standard Deviation|Mean
2686492|NCT01349920|Primary|Change From Baseline in Serum hsCRP at Week 22|Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 22. The change from baseline was Week 22 minus baseline.|Baseline and Week 22|Participants with measurements for hsCRP at both baseline and at Week 22.|||mg/L||Standard Deviation|Mean
2686493|NCT01349920|Primary|Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at Week 6|Concentrations of the serum biomarker hsCRP were determined at baseline and at Week 6. The change from baseline was Week 6 minus baseline.|Baseline and Week 6|Participants with measurements for hsCRP at both baseline and at Week 6.|||mg/L||Standard Deviation|Mean
2686494|NCT01349920|Primary|Change From Baseline in CDEIS Blinded Score at Week 22|CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 22 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.|Baseline and Week 22|Participants who had a blinded CDEIS score at both baseline and at Week 22.|||Score on a scale||Standard Deviation|Mean
2686495|NCT01349920|Primary|Change From Baseline in the Crohn's Disease Endoscopic Index of Severity (CDEIS) Blinded Score at Week 6|CDEIS endoscopically assesses mucosal status, by summing the following six component scores: number of bowel segments with deep ulcerations divided by number of visualized bowel segments; number of bowel segments with superficial ulcerations divided by number of visualized bowel segments; mean proportion of bowel segment surface involved by disease measured on 0-10 cm visual analog scale (VAS); mean proportion of bowel segment surface area involved by ulcerations measured on 0-10 cm VAS; presence of ulcerated stenosis anywhere; and presence of non-ulcerated stenosis anywhere. An observer who viewed procedural videotape while blinded to the allocation number and visit of the endoscopy scored the CDEIS. The sum of the six components can range from 0-44, with a higher sum indicating greater severity of mucosal inflammation. Change from baseline is defined as Week 6 minus baseline CDEIS scores, with a negative change from baseline indicating improvement.|Baseline and Week 6|Participants who had a blinded CDEIS score at both baseline and at Week 6.|||Score on a scale||Standard Deviation|Mean
2686496|NCT01349907|Secondary|Change From Baseline in PQ-LES-Q Overall Score|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant rates 15 items reflecting quality of life from the previous week. Item 15, the PQ-LES-Q overall score, observed OC, is a global assessment of overall quality of life, and ranges from 1 to 5, with a higher score indicating better quality of life. An improvement in quality of life is represented by change from baseline values that are positive.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Score on a scale||Standard Deviation|Mean
2686546|NCT01349790|Secondary|Maximum Platelet Count|The maximum platelet count achieved during the study is presented.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration.|||10^9 platelets/L||Standard Deviation|Mean
2686497|NCT01349907|Secondary|Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaires (PQ-LES-Q) Total Score|PQ-LES-Q is a questionnaire to assess quality of life enjoyment and satisfaction in children and adolescents. The participant rates 15 items reflecting quality of life from the previous week on a scale of 1=very poor to 5=very good. Items 1-14 assess specific areas (e.g., health, mood or feelings); item 15 is a global assessment of overall quality of life. The PQ-LES-Q total score for each participant, OC is the sum of the rating assigned to each of the first 14 items, and ranges from 14 to 70, with a higher score indicating better quality of life. An improvement in quality of life is represented by change from baseline values that are positive.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Score on a scale||Standard Deviation|Mean
2686498|NCT01349907|Secondary|Percentage of Participants With a CGAS Score of Equal or Greater Than 70|CGAS is a scale with a possible range of 1 to 100, measuring psychological, social, and school functioning in children. Minimum scores, OC range from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). The percentage of participants with a score of 70 or greater, representing normal to superior social functioning, is shown.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Percentage of participants|||Number
2686499|NCT01349907|Secondary|Change From Baseline in Children's Global Assessment Scale (CGAS)|CGAS is a scale with a possible range of 1 to 100, measuring psychological, social, and school functioning in children. Minimum scores, OC range from 1-10, representing the need for constant supervision (worse result) to maximum scores of 91-100, representing superior functioning (better result). An improvement in function is represented by a change from baseline value that is positive.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Score on a scale||Standard Deviation|Mean
2686500|NCT01349907|Secondary|Percentage of Participants With Emergent Depression Based on CDRS-R|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. The CDRS-R total score, OC for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. Participants with a CDRS-R score of 40 or greater (whose baseline CDRS-R is less than 40) exhibit emergent depression, which is a strong indicator of the presence or potential for a major depressive disorder.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Percentage of participants|||Number
2686501|NCT01349907|Secondary|Percentage of CDRS-R Responders|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. The CDRS-R total score, OC for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. A CDRS-R responder experiences a 50% or more decrease from baseline in CDRS-R total score.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Percentage of participants|||Number
2686502|NCT01349907|Secondary|Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score|The CDRS-R is a 17-item clinician-rated instrument for assessing the presence and severity of depressive symptoms in children. Fourteen of the 17 items are rated on a scale of 1-7, and 3 of the items are rated on a scale of 1-5, with higher scores indicating greater severity of symptoms. The CDRS-R total score, OC for each participant is the sum of the ratings for the 17 individual items, and can range from 17-113, with higher scores indicating greater severity of symptoms. Improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Score on a scale||Standard Deviation|Mean
2686503|NCT01349907|Secondary|Change From Baseline in Clinical Global Impression Scale for Assessing Mania (CGI-BP Mania)|The CGI-BP mania is a single value score OC for assessing mania, recorded on a 7-point scale ranging from 1 for normal/not ill, to 7 for very severely ill. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Score on a scale||Standard Deviation|Mean
2686504|NCT01349907|Secondary|Change From Baseline in Clinical Global Impression Scale for Assessing Depression (CGI-BP Depression)|The CGI-BP depression is a single value score OC for assessing depression, recorded on a 7-point scale ranging from 1 for normal/not ill, to 7 for very severely ill. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Score on a scale||Standard Deviation|Mean
2686505|NCT01349907|Secondary|Change From Baseline in Clinical Global Impression Scale for Assessing Overall Bipolar Illness (CGI-BP Overall)|The CGI-BP overall is a single value score OC for assessing overall bipolar illness, recorded on a 7-point scale ranging from 1 for normal/not ill, to 7 for very severely ill. An improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Score on a scale||Standard Deviation|Mean
2686506|NCT01349907|Secondary|Time to Failure to Maintain Response in Y-MRS Total Score|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC for each participant is the sum of the ratings for the 11 individual items, ranging from 0-60, with higher scores indicating more severe symptoms. The time to failure is the number of days from first achieving a 50% or more decrease from baseline in Y-MRS total score to the first subsequent day of a less than 50% decrease from baseline in Y-MRS total score.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment. Restricted to participants who were total Y-MRS 50% responders in base trial P06107.|||Days||95% Confidence Interval|Median
2686507|NCT01349907|Secondary|Time to First Total Y-MRS 50% Response|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC for each participant is the sum of the ratings for the 11 individual items, ranging from 0-60, with higher scores indicating more severe symptoms. The time to 50% response is the number of days on treatment to achieve a 50% decrease from baseline in Y-MRS total score.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Days||95% Confidence Interval|Median
2686508|NCT01349907|Secondary|Percentage of Participants Who Were Y-MRS Total Score Responders|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms. A Y-MRS responder experiences a 50% or more decrease from baseline in Y-MRS total score.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Percentage of participants|||Number
2686509|NCT01349907|Secondary|Percentage of Participants Who Were Y-MRS Total Score Remitters (Y-MRS ≤12)|The Y-MRS is an 11-item clinician-rated instrument for assessing the severity of manic episodes. The Y-MRS total score, OC for each participant is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms. A remitter is a participant with a Y-MRS total score of 12 or lower.|Up to Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Percentage of participants|||Number
2686510|NCT01349907|Secondary|Change From Baseline in Young Mania Rating Scale (Y-MRS) Total Score|The Y-MRS assesses the severity of manic episodes by assigning a severity rating to each of 11 items (Elevated mood, Increased motor activity-energy, Sexual interest, Sleep, Irritability, Speech, Language-thought disorder, Thought content, Disruptive-aggressive behavior, Appearance, Insight). Seven of the 11 items are rated on a scale of 0-4, and 4 of the items are rated on a scale of 0-8. The Y-MRS total score, observed cases (OC), the assessment closest to the scheduled assessment day within the allowed window, is the sum of the ratings for the 11 individual items, and can range from 0-60, with higher scores indicating greater severity of symptoms. Improvement in symptoms is represented by change from baseline values that are negative.|Baseline, Day 182 and Day 350|Participants 17 years old or younger, who have taken at least one dose of trial medication, and have a baseline, and at least one post-baseline Y-MRS assessment.|||Score on a scale||Standard Deviation|Mean
2686511|NCT01349907|Primary|Number of Participants Who Experienced Clinical or Laboratory Adverse Events|A clinical or laboratory adverse event is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.|Baseline (Day 1) to 30 days after the last dose of study drug (up to approximately 54 weeks)|Participants who received at least one dose of trial medication, and were 17 years old or younger. One treated participant from the Placebo/Asenapine group, who was 18 years old, was excluded from this analysis.|||Participants|||Number
2686512|NCT01349829|Secondary|Geometric Mean Concentrations (GMCs)|GMCs of anti-HAV antibodies will be measured from blood samples|Month 7|Results are for the ATP population included all randomized subjects who received the first and second vaccination and had negative anti-HAV antibody concentrations at baseline, no major protocol violations and whose serum sample after the second vaccination was available for measurement of immunogenicity|||mIU/mL||95% Confidence Interval|Mean
2686513|NCT01349829|Secondary|Geometric Mean Concentrations (GMCs)|GMCs of anti-HAV antibodies will be measured from blood samples|Month 6|Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentrations at screening, no major protocol violations and whose serum sample was available for measurement of immunogenicity|||mIU/mL||95% Confidence Interval|Mean
2686514|NCT01349829|Secondary|Geometric Mean Concentrations (GMCs)|GMCs of anti-HAV antibodies will be measured from blood samples|Month 1|Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentration at screening, and who had no major protocol violations and whose serum sample after the first vaccination was available for measurement of immunogenicity|||mIU/mL||95% Confidence Interval|Mean
2686515|NCT01349829|Secondary|Seroprotection at Month 7|Proportion of subjects seroprotected (>=10 mIU/ml)|Month 7|Results are for the ATP population included all randomized subjects who received the first and second vaccination and had negative anti-HAV antibody concentrations at baseline, no major protocol violations and whose serum sample after the second vaccination was available for measurement of immunogenicity|||percentage of participants||95% Confidence Interval|Number
2686516|NCT01349829|Secondary|Seroprotection at Month 6|Proportion of subjects seroprotected (>=10 mIU/ml)|Month 6|Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentrations at screening, no major protocol violations and whose serum sample was available for measurement of immunogenicity|||percentage of participants||95% Confidence Interval|Number
2686517|NCT01349829|Primary|Seroprotection at Month 1|Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration >=10 mIU/ml)|Month 1|Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentration at screening, and who had no major protocol violations and whose serum sample after the first vaccination was available for measurement of immunogenicity|||percentage of participants||95% Confidence Interval|Number
2686518|NCT01349816|Secondary|Mean Evening Trough FEV1|Change from baseline in mean evening 12-hour post-dose trough FEV1|Day 7|MITT Population|||Liters||95% Confidence Interval|Least Squares Mean
2686519|NCT01349816|Secondary|Peak Change From Baseline in IC|Peak change from baseline in inspiratory capacity (IC) (mean of 1 and 2 hours post-dose minus baseline)|Day 7|MITT Population|||Liters||95% Confidence Interval|Least Squares Mean
2686520|NCT01349816|Secondary|FEV1 Through 6 Hours|Peak change from baseline in FEV1 through 6 hours|Day 7|MITT Population|||Liters||95% Confidence Interval|Least Squares Mean
2686521|NCT01349816|Secondary|Morning Pre-dose FEV1|Change from baseline in morning pre-dose FEV1 (average of 60- and 30-minute pre-dose values on Day 7)|Day 7|MITT Population|||Liters||95% Confidence Interval|Least Squares Mean
2686527|NCT01349803|Secondary|Mean Change From Baseline in QTcF Interval|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, Day 7, and Day 14|Safety Population|||msec||Standard Deviation|Mean
2686528|NCT01349803|Secondary|Change From Baseline in the Number of Tachycardia Episodes Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||Tachycardia episodes / hour||Standard Error|Mean
2686529|NCT01349803|Secondary|Change From Baseline in the Number of Bradycardia Episodes Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||Bradycardia episodes / hour||Standard Error|Mean
2686530|NCT01349803|Secondary|Change From Baseline in the Number of Supraventricular Runs Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||Supraventricular runs / hour||Standard Error|Mean
2686531|NCT01349803|Secondary|Change From Baseline in the Number of Supraventricular Couplets Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||Supraventricular couplets / hour||Standard Error|Mean
2686532|NCT01349803|Secondary|Change From Baseline in the Number of Isolated Supraventricular Events Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||Supraventricular events / hour||Standard Error|Mean
2686533|NCT01349803|Secondary|Change From Baseline in the Number of Ventricular Runs Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||Ventricular runs / hour||Standard Error|Mean
2686534|NCT01349803|Secondary|Change From Baseline in the Number of Ventricular Couplets Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||Ventricular couplets / hour||Standard Error|Mean
2686545|NCT01349790|Secondary|Percentage of Responders Who Achieved a Normal Platelet Count|The percentage of responders who achieved a normal platelet count is presented.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only responders were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
2688187|NCT01335724|Secondary|Neck Disability Index|"Neck Disability Index total score. Minimum = 0 Best. Maximum = 50 Worst"|96h||||Total Score||Standard Deviation|Mean
2686535|NCT01349803|Secondary|Change From Baseline in Number of Isolated Ventricular Events Recorded During 24-Hour Holter Monitoring|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||Ventricular events / hour||Standard Error|Mean
2686536|NCT01349803|Secondary|Change From Baseline in 24-Hour Minimum Heart Rate|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||bpm||95% Confidence Interval|Least Squares Mean
2686537|NCT01349803|Secondary|Change From Baseline in 24-Hour Maximum Heart Rate|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||bpm||95% Confidence Interval|Least Squares Mean
2686538|NCT01349803|Secondary|Change From Baseline in Night Time Mean Heart Rate|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||bpm||95% Confidence Interval|Least Squares Mean
2686539|NCT01349803|Secondary|Change From Baseline in Daytime Mean Heart Rate|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|Baseline, Day 1, and Day 14|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||bpm||95% Confidence Interval|Least Squares Mean
2686540|NCT01349803|Secondary|Change From Baseline in 24-Hour Mean Heart Rate for Day 1 of Treatment|The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).|24 hours|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||bpm||95% Confidence Interval|Least Squares Mean
2686541|NCT01349803|Secondary|Change From Baseline in Mean FEV1 Trough|Trough FEV1 averaged over Day 7 and Day 14|Day 7 to Day 14|MITT - patients from the ITT population who completed at least one evaluable FEV1 spirometry assessment for baseline (pre-dose on Day 1) and had an evaluable FEV1 spirometry assessment on at least one of the following: Day 7 pre-dose or Day 14 pre-dose (or both).|||Liters||95% Confidence Interval|Least Squares Mean
2686542|NCT01349803|Primary|Change From Baseline in 24-Hour Mean Heart Rate Post-dose|The primary safety objective of this study was to compare the change in mean heart rate averaged over 24 hours post-dose, following twice daily dosing over 14 days with PT003 MDI, PT005 MDI, PT001 MDI or Foradil Aerolizer compared to baseline in patients with moderate to severe chronic obstructive pulmonary disease (COPD).|14 days|Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.|||bpm||95% Confidence Interval|Least Squares Mean
2686543|NCT01349790|Secondary|Percentage of Participants Who Achieved a Platelet Count > 30x10^9/L|The percentage of participants who achieved a platelet count > 30x10^9/L within 1 and 2 days after infusion is reported.|Day 1 to Day 2|Safety set: All participants enrolled in the study who received at least part of 1 dose of NewGam.|||Percentage of participants|||Number
2686544|NCT01349790|Secondary|Bleeding Intensity|The percentage of participants with various intensities of overall bleeding, epistaxis (bleeding of the nose), oral bleeding, and skin bleeding graded as none, minor, mild, moderate, or severe at Baseline and Day 22 are reported.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration.|||Percentage of participants|||Number
2686547|NCT01349790|Secondary|Platelet Count by Visit|The platelet count at each study visit are presented.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration.|||10^9 platelets/L||Standard Deviation|Mean
2686548|NCT01349790|Secondary|Duration of a Complete Response|The duration of a complete response was defined as the time from when a complete response was achieved until the platelet count fell below 50x10^9/L.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only participants with a complete response were included in the analysis.|||Days||95% Confidence Interval|Median
2686549|NCT01349790|Secondary|Duration of an Alternative Response|The duration of an alternative response was defined as the time from when an alternative response was achieved until the platelet count fell below 50x10^9/L.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only participants with an alternative response were included in the analysis.|||Days||95% Confidence Interval|Median
2686550|NCT01349790|Secondary|Duration of a Response|The duration of a response was defined as the time from when a response was achieved until the platelet count fell below 50x10^9/L.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only responders were included in the analysis.|||Days||95% Confidence Interval|Median
2686551|NCT01349790|Secondary|Time to a Complete Response|A study participant had a complete response if their platelets increased to ≥ 100x10^9/L, confirmed on at least 2 occasions at least 7 days apart, and absence of bleeding.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only participants with a complete response were included in the analysis.|||Days||95% Confidence Interval|Median
2686552|NCT01349790|Secondary|Time to an Alternative Response|A study participant had a response if their platelets increased to ≥ 30x10^9/L and to at least double the baseline platelet count, confirmed on at least 2 occasions at least 7 days apart, and absence of bleeding.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only participants with an alternative response were included in the analysis.|||Days||95% Confidence Interval|Median
2686553|NCT01349790|Secondary|Time to a Response|A study participant had a response if their platelets increased to ≥ 50x10^9/L within 7 days after the first infusion, ie, by study Day 8.|Day 1 to Day 8|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam who had at least 1 post-baseline measurement of platelet concentration. Only responders were included in the analysis.|||Days||95% Confidence Interval|Median
2686554|NCT01349790|Secondary|Percentage of Complete Responders Who Lost the Response|A complete responder who lost the response is a study participant who met the criterion for a complete response but who then deteriorated, ie, their platelet count decreased to < 100x10^9/L or bleeding occurred.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam and who had at least 1 post-baseline measurement of platelet concentration. Only participants with a complete response were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
2686555|NCT01349790|Secondary|Percentage of Alternative Responders Who Lost the Response|An alternative responder who lost the response is a study participant who met the criterion for an alternative response but who then deteriorated, ie, their platelet count decreased to < 30x10^9/L, their platelet count decreased to less than double the baseline count, or bleeding occurred.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam and who had at least 1 post-baseline measurement of platelet concentration. Only participants with an alternative response were included in the analysis.|||Percentage of participants||95% Confidence Interval|Number
2686556|NCT01349790|Secondary|Percentage of Complete Responders|A complete responder is a study participant with an increase in platelets to ≥ 100x10^9/L, confirmed on at least 2 occasions at least 7 days apart, and absence of bleeding.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam and who had at least 1 post-baseline measurement of platelet concentration.|||Percentage of participants||95% Confidence Interval|Number
2686557|NCT01349790|Secondary|Percentage of Alternative Responders|An alternative responder is a study participant with an increase in platelets to ≥ 30x10^9/L and to at least double the baseline platelet count, confirmed on at least 2 occasions at least 7 days apart, and absence of bleeding.|Day 1 to Day 22|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam and who had at least 1 post-baseline measurement of platelet concentration.|||Percentage of participants||95% Confidence Interval|Number
2686558|NCT01349790|Primary|Percentage of Responders|A responder is a study participant with an increase in platelets to ≥ 50x10^9/L within 7 days after the first infusion, ie, by study Day 8.|Day 1 to Day 8|Full analysis set: All participants enrolled in the study who received at least part of 1 dose of NewGam and who had at least 1 post-baseline measurement of platelet concentration.|||Percentage of participants||95% Confidence Interval|Number
2686559|NCT01349673|Secondary|Number of Participants With A Clinically Notable Physical Examination Finding Since Baseline|A full or complete physical examination was performed at the Study Baseline. This physical examination included (but was not limited to): general appearance, head, ear, eyes, nose, throat, respiratory, cardiovascular, gastrointestinal, abdominal, neurological, lymphatic, dermatologic, and musculoskeletal. A symptom-directed physical examination was performed on Visit 2 (Day 1) to Visit 4 (Day 42) per Cycle (at the Investigator's discretion) and as needed for unscheduled clinic visits. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline through up to Cycle 8 (Cycle=6 weeks)|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2686560|NCT01349673|Secondary|Changes In Baseline In Mean Morning (AM) Fasting Serum Cortisol Levels|Fasting cortisol levels were evaluated, and cortisol was taken in the morning (AM cortisol) approximately 2 to 4 hours after waking. Data for cycles with more than 15 participants at the Cycle Baseline is reported.|Baseline of Cycles 1-4, Day 15 and Day 42 of Cycles 1-4 (Cycle=6 weeks)|All participants who received at least 1 dose of study drug and with non-missing cortisol value at the specified timepoint.|||nanomoles per liter (nmol/L)||Standard Deviation|Mean
2686561|NCT01349673|Secondary|Clinically Notable Laboratory Parameters|Clinically notable laboratory parameters are defined as clinical laboratory values outside the reference range. Reference ranges for the clinical notable laboratory parameters: Aspartate Aminotransferase - 0-37 microliters (U/L); Alanine Aminotransferase - 0-47 U/L; Lactate Dehydrogenase - 110-250 U/L. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline and Cycle 4 (Cycle=6 weeks)|All participants who received at least 1 dose of study drug and with non-missing clinical laboratory parameter values at the specified timepoint.|||U/L||Full Range|Mean
2686562|NCT01349673|Primary|Number Of Participants Reporting A Non-serious Adverse Event And A Serious Adverse Event|A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.|Baseline through up to Cycle 8 (Cycle=6 weeks)|All participants who received at least 1 dose of study drug.|||Participants|||Count of Participants
2686563|NCT01349660|Secondary|Number of Participants With Grade 3/4/5 Serious Adverse Events and Adverse Events as a Measure of Safety and Tolerability|Defined as the number of participants with treatment-emergent grade 3/4/5 adverse events/serious adverse events utilizing the National Cancer Institute Common Technology Criteria for Adverse Events (NCI CTCAE) v4.03|every 4 weeks for up to 5.2 years|Includes all participants that received at least one dose of study treatment|||Participants|||Count of Participants
2686564|NCT01349660|Secondary|Median Overall Survival (OS) in Phase II Participants - Prior Bevacizumab and Bevacizumab Naive|Two groups of patients in the Phase II trial will be considered separately, 1) participants who have not received previous bevacizumab and 2) participants who have received bevacizumab as part of first-line treatment. Overall survival is measured as the interval from first study treatment until date of death, or date last known alive.|every 12 weeks for up to 60 months|Participants that have received at least one dose of study treatment|||months||95% Confidence Interval|Median
2686565|NCT01349660|Secondary|Overall Response (CR or PR) of Phase II Participants - Prior Bevacizumab and Bevacizumab Naive|Two groups of participants in the Phase II trial will be considered separately, 1) those who have not received previous bevacizumab and 2) those who have received bevacizumab as part of first-line treatment. Overall Response (OR) = number of patients with complete or partial responses (CR or PR) per McDonald or RANO criteria. McDonald: CR as disappearance of all disease for at least four weeks, no new lesions, no steroids; PR as 50% or greater decrease in the sum of all lesions compared with baseline for at least four weeks, no new lesions, stable or reduced steroids (McDonald 1990). RANO: CR as disappearance of all disease for at least 4 weeks, no new lesions, stable or improved nonenhancing lesions, and no steroid usage; and PR as a 50% or greater decrease in the sum of all lesions compared with baseline measurement for at least four weeks, no new lesions, stable or improved nonenhancing lesions on same or lower steroid dose compared to baseline (Wen 2010).|every 8 weeks, projected 24 months|Includes participants in Phase II that receive at least one study treatment and have at least one post-baseline disease assessment.|||Participants|||Count of Participants
2686566|NCT01349660|Primary|Median Progression-Free Survival (PFS) in Phase II Participants - Prior Bevacizumab and Bevacizumab Naive|Two groups of patients in the Phase II trial will be considered separately, 1) participants who have not received previous bevacizumab and 2) participants who have received bevacizumab as part of first-line treatment. PFS is measured from the date of first protocol treatment until date of disease progression or death occurs, or date of last adequate tumor assessment using RANO or McDonald criteria. McDonald disease progression criteria: a 25% or greater increase in sum of the diameters of lesions, new lesions, or clinical deterioration (McDonald et al, 1990). RANO disease progression criteria: a 25% or greater increase in the enhancing lesions sum compared with smallest tumor measurement, significant increase in T2/FLAIR nonenhancing lesion on stable or increasing corticosteroids, new lesions, or clinical deterioration (Wen et al 2010)|every 8 weeks for up to 33 months|All Phase II patients receiving at least one dose of study treatment that have had at least one post-baseline disease assessment|||months||95% Confidence Interval|Median
2686567|NCT01349660|Primary|Number of Phase I Patients Receiving 60mg or 80mg BKM120 Experiencing a Dose-Limiting Toxicity (DLT) to Determine the Optimal Dosage|The optimal dose of BKM120 to administer in combination with standard dose bevacizumab determined as the dose at which ≤1 of 6 patients experiences a DLT assessed using NCI CTCAE v4.03 during Cycle 1 (28 days). The optimal dose of BKM120 was determined to be 60 mg by mouth (PO), once a day for each 28 day cycle along with bevacizumab, administered 10 mg/kg intravenously (IV) on Day 1 and Day 15 of each 28 day cycle.|Collected from day of first dose to the end of the first treatment cycle, up to 28 days|Includes all Phase I patients receiving assigned study dosing.|||Participants|||Count of Participants
2686568|NCT01349595|Primary|The Incidence of a Combined Endpoint of Death-censored Graft Loss or Greater Than 50% Reduction in Estimated Glomerular Filtration (eGFR) in Study Subjects.||60 months after enrollment in the study|Results data for zero participants were analyzed; long-term follow-up evaluation of participants was not possible due to discontinuation of funding.||||||
2686569|NCT01349569|Secondary|Tumor-specific Immunity as Assessed by Percentage of CD3+/CSFSE-low/IFN-gamma+ Cells|Immunity is measured by the percentage of CD3+/CSFSE-low/IFN-gamma+ cells. A positive result for a given participant is defined as greater than two standard deviations above that participant's baseline. The data are presented as three groups because the responses were analyzed separately, but all participants were part of the single study arm as represented by the remainder of the record. GVAX-specific immune response and Prevnar-specific immune response was assessed in the same patient by using GVAX and Prevnar-specific co-markers.|Baseline, Cycle 3 Day 14, end of study (up to 1 year)|Out of the 16 baseline participants, one received only one dose of vaccine and then had progression of disease. He was replaced and not included in this analysis. Only 8/15 participants experienced complete response (CR), therefore only 8 participants analyzed in the CR rows and 7 participants analyzed in the progressive disease (PD) rows.|||percentage of cells||Standard Deviation|Mean
2686570|NCT01349569|Secondary|Grade 3-4 Toxicity|Number of participants who experienced grade 3-4 toxicity as per CTCAE 4.0.|Up to 1 year||||Participants|||Count of Participants
2686571|NCT01349569|Secondary|Effect on Clonogenic Myeloma Precursors|Measures of stem cell population and plasma cell population.|Baseline, Cycle 3 Day 14, Cycle 6 Day 14, and 1 year|Data was not collected for this outcome measure due to technical difficulties in the assay.||||||
2688188|NCT01335724|Secondary|Pain at Rest|"Pain at Rest on a 100 mm visual analog scale. Minimum score =0 mm no pain. Maximum score =100 mm extreme pain."|96h||||mm||Standard Deviation|Mean
2686572|NCT01349569|Secondary|Time to Response|"Median time for conversion of response from near complete remission (nCR) to complete remission (CR) as measured by the International Myeloma Working Group Uniform Response Criteria. Near complete remission is defined as negative serum and urine electrophoresis, < 5% plasma cells in the bone marrow, and positive serum and/or urine immunofixation. Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells.~as measured by immunofixation converting from positive to negative."|Up to 4 years|Out of the 16 baseline participants, one received only one dose of vaccine and then had progression of disease. He was replaced and not included in this analysis.|||months||Full Range|Median
2686573|NCT01349569|Primary|Response Conversion Rate|Number of participants who converted from near complete remission (nCR) to complete remission (CR) as measured by the International Myeloma Working Group Uniform Response Criteria. Near complete remission is defined as negative serum and urine electrophoresis, < 5% plasma cells in the bone marrow, and positive serum and/or urine immunofixation. Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with < 5% plasma cells.|Up to 1 year|Out of the 16 baseline participants, one received only one dose of vaccine and then had progression of disease. He was replaced and not included in this analysis.|||Participants|||Count of Participants
2686574|NCT01349491|Primary|Primary Outcome - Number of Participants With Atrial Fibrillation|To determine if ranolazine is effective in decreasing recurrences of AF in patients with persistent AF successfully treated with electrical cardioversion.|6 months||||participants|||Number
2686575|NCT01349465|Primary|Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study|Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.|Baseline and Month 36|"N signifies number of particpants with no SVR at LPVPS and with available sequence data. n defines the number of participants analyzed at specified time point."|||Percentage of participnats|||Number
2686576|NCT01349465|Primary|Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study|Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.|Baseline and Month 36|"N signifies number of particpants with no SVR at LPVPS and with available sequence data. n defines the number of participants analyzed at specified time point."|||Percentage of participants|||Number
2686577|NCT01349465|Secondary|Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability||End of study (at month 36)||||Participants|||Number
2686578|NCT01349465|Secondary|Percentage of Participants With Late Viral Relapse|Relapse at any time after the LPVPS until the last individual visit of this study. All participants maintained SVR until the last available visit. No late viral relapse was therefore observed.|End of study (at month 36)|Late viral relapse was evaluated in all enrolled participants with SVR at LPVPS.|||percentage of participants|||Number
2686579|NCT01349465|Primary|Overall Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study|Sequencing was performed to assess changes in the sequence of the HCV NS3/4A protein region over time in participants with no SVR at LPVPS (ie confirmed detectable HCV RNA at the last visit of the previous study). EOS defined as last available sequencing sample. AEM and NEM represents any emerging mutation and no emerging mutation at time of failure of the previous study.|Baseline and Month 36|"N signifies number of participants with no SVR at LPVPS and with available sequence data. n defines the number of participants analyzed at specified time point."|||Percentage of participants|||Number
2686580|NCT01349465|Primary|Percentage of Participants Maintaining SVR at the Last Available Visit|The SVR rate is the proportion (%) of participants with HCV RNA less than (<) 25 International Units/milliliter (IU/mL).|Last Available Visit (Month 36 for subjects completing the study)|All participants with SVR at LPVPS were included in the population analysis set.|||Percentage of participants||95% Confidence Interval|Number
2686581|NCT01349231|Secondary|Depression Symptoms|We will examine change from baseline in Hamilton Rating Scale for Depression (HRDS) ratings of depression severity at day 1-3 following a single ketamine infusion. The HRDS assesses severity of, and change in, depressive symptoms. The HRDS is a 21 item scale with scores ranging from 0-66. The higher the score, the more severe the depression.|Baseline, Day 1, Day 2, and Day 3||||units on a scale||Standard Deviation|Mean
2686582|NCT01349231|Primary|OCD Severity|We will examine change from baseline in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) ratings of OCD severity at 3 days following infusion. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) assesses obsessive and compulsive symptom severity. Obsessions are rated on a scale from 0-20 and compulsions are rated on a scale of 0-20, for a total scale of 0-40. Scores on the obsessions scale and scores on the compulsions scale are summed to obtain the total score. The higher the score, the more severe the OCD.|Baseline and 3 days following infusion||||units on a scale||Standard Deviation|Mean
2686583|NCT01349231|Primary|OCD Severity|We will examine change from baseline in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) ratings of OCD severity at 2 days following infusion. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) assesses obsessive and compulsive symptom severity. Obsessions are rated on a scale from 0-20 and compulsions are rated on a scale of 0-20, for a total scale of 0-40. Scores on the obsessions scale and scores on the compulsions scale are summed to obtain the total score. The higher the score, the more severe the OCD.|Baseline and 2 days following infusion||||units on a scale||Standard Deviation|Mean
2686626|NCT01348542|Primary|Change in Objective Actigraphy Sleep Duration From Baseline to Follow up (9 Months)|Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and follow up (9 months)|Baseline to follow up (9 months)|From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis.|||minutes||Standard Deviation|Mean
2686584|NCT01349231|Primary|OCD Severity|We will examine change from baseline in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) ratings of OCD severity at 1 day following infusion. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) assesses obsessive and compulsive symptom severity. Obsessions are rated on a scale from 0-20 and compulsions are rated on a scale of 0-20, for a total scale of 0-40. Scores on the obsessions scale and scores on the compulsions scale are summed to obtain the total score. The higher the score, the more severe the OCD.|Baseline and 1 day after ketamine infusion||||units on a scale||Standard Deviation|Mean
2686585|NCT01349192|Secondary|Pulmonary Exacerbations|Proportion of subjects with a protocol-defined pulmonary exacerbation (PE) between baseline and day 28 who are treated with antibiotics active against MRSA.|28 days|Intention to treat|||Participants|||Count of Participants
2686586|NCT01349192|Secondary|Antibiotic Use (Days of Use Per Subject)|Days of use of oral, inhaled, and IV antibiotics over the 6 month study.|6 months|Intention to treat|||days||Standard Deviation|Mean
2686587|NCT01349192|Secondary|Antibiotic Use (Proportion of Subjects)|Proportion of subjects treated with oral, inhaled, and IV antibiotics over the 6 month study.|6 months|Intention to treat|||Participants|||Count of Participants
2686588|NCT01349192|Primary|MRSA Culture Status|Proportion of subjects with a negative culture for MRSA at Day 28.|Day 28|The analysis population is defined as all of the participants who were randomized to a study arm and were assessed for the primary microbiologic efficacy endpoint at both baseline and Day 28.|||Participants|||Count of Participants
2686589|NCT01349114|Secondary|Mean Central Aortic Pressure at 3 Months|Baseline to 3 months after Aliskiren/PLC, reported value at 3 months after start of study of central aortic pressure assessed by non-invasive applanation tonometry ( SphygmoCor, Atcor)|3 months after start of study|Aortic pressure indicates the augmentation pressure (AP) in mmHg derived from the radial artery waveform.|||mm Hg||Standard Deviation|Mean
2686590|NCT01349114|Primary|Change in Flow-mediated Dilation|Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion|Baseline to 3 months||||percentage of flow-mediated dilation||Standard Deviation|Mean
2686591|NCT01349049|Other Pre-specified|A Summary of Time From Initial Dosing to First and Best Response, Modified Response Criteria in Patient Treated With PLX3397 (Dose Expansion, Part 2)||1 year post dose|Efficacy analyses were assessed in Part 2 Efficacy Population|||days||90% Confidence Interval|Median
2686592|NCT01349049|Secondary|Number of Participants With Clinically Significant Abnormal Chemistry and Hematology Values Reported as Adverse Events (AE) During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)||1 year post dose|Adverse events were assessed in the Safety Population.|||Participants|||Count of Participants
2686593|NCT01349049|Secondary|Number of Participants Reporting a Treatment Emergent Adverse Events With a CTCAE Grade ≥3 During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)|Data reported are Treatment Emergent Adverse Events with a CTCAE Grade ≥3 During Treatment that are ≥10% Occurrence in all patients.|1 year post dose|Adverse events were assessed in the Safety Population.|||Participants|||Count of Participants
2686594|NCT01349049|Secondary|Number of Participants Reporting an Incidence of Treatment-Related Treatment Emergent Adverse Events During Treatment With PLX3397 (Dose Escalation, Part 1 and Dose Expansion, Part 2)|Data reported are Treatment-Related Treatment Emergent Adverse Events that are ≥15% Occurrence in all patients.|1 year post dose|Adverse events were assessed in the Safety Population.|||Participants|||Count of Participants
2686595|NCT01349049|Secondary|Number of Participants Reporting an Incidence of Adverse Events During Treatment With PLX3397 (Part 1, Dose Escalation and Part 2, Dose Expansion)||1 year post dose|Adverse events were assessed in the Safety Population.|||Participants|||Count of Participants
2686596|NCT01349049|Secondary|Number of Participants With On-treatment Best Classic Criteria Response Results During Treatment With PLX3397 (Dose Expansion, Part 2)|"Complete Remission (CR):~Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count >1.0 x 109/L (1000/μL); platelet count >100 x 109/L (100000/μL); red cell transfusion independent~CR with incomplete recovery (CRi):~All CR criteria except for residual neutropenia (<1.0 x 109/L) or thrombocytopenia~Partial Remission (PR):~All hematologic criteria of CR; decrease of bone marrow blast percentage to 5-25%; decrease of pretreatment bone marrow blast percentage by at least 50%."|1 year post dose|Efficacy analyses were conducted in the Part 2 Efficacy Population.|||Participants|||Count of Participants
2686597|NCT01349049|Secondary|Number of Participants With On-treatment Best Modified Criteria Response Results of Partial Remission (PR) During Treatment With PLX3397 (Dose Expansion, Part 2)|Modified International Working Group Response Criteria for Acute Myeloid Leukemia defines Partial Remission (PR) as the following: Partial Remission (PR): Patients must have bone marrow regenerating normal hematopoietic cells with evidence of peripheral recovery with no (or only a few regenerating) circulating blasts and with a decrease of at least 50% in the percentage of blasts in the bone marrow aspirate with the total marrow blasts between 5% and 25%. In addition, patients do not need to be Red Blood Cell (RBC) or platelet transfusion independent.|1 year post dose|Efficacy analyses were conducted in the Part 2 Efficacy Population.|||Participants|||Count of Participants
2686598|NCT01349049|Primary|Summary of Time-to-Event Endpoints in Patients on Treatment With PLX3397 (Dose Expansion, Part 2)|Median survival estimates were based on the Kaplan-Meier method. In the event disease progression/relapse or death was not documented prior to study termination, endpoints were censored at the date of last evaluable tumor assessment. Duration of remission, duration of complete remission, and disease-free survival, initial response was based on the modified response criteria. Duration of complete remission was defined as the number of days from the date of initial CR, CRp, or CRi response to the date of first documented disease relapse or death, whichever occurred first. Disease-free survival was defined as the number of days from the date of initial CR, CRp, or CRi to the date of documented disease relapse or death from any cause, whichever occurred first.|1 year post dose|Time-to-event analyses were assessed in the Part 2 Efficacy Population.|||days||90% Confidence Interval|Median
2686627|NCT01348542|Primary|Change in Objective Actigraphy Sleep Duration From Baseline to Post Treatment (3 Months)|Actigraphy (ad libitum time in bed) will be used to measure sleep duration at baseline and Post Treatment (3 months)|Baseline to Post Treatment (3 months)|From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis.|||minutes||Standard Deviation|Mean
2686599|NCT01349049|Primary|Summary of Best Modified Criteria Response Results, Bridged-to-Transplant (BTT) Participants, and Composite Remission Rates in Patients on Treatment With PLX3397 (Dose Expansion, Part 2).|Complete remission (CR): Has bone marrow regenerating normal cells, achieve a morphologic leukemia-free state, Complete remission with incomplete platelet recovery (CRp): CR except for incomplete platelet recovery, Complete remission with incomplete recovery (CRi): CR except for incomplete hematological recovery with residual neutropenia, Partial response (PR): bone marrow generates normal hematopoietic cells, evidence of peripheral recovery with no or a few regenerating circulating blasts. Decrease of ≥50% of blasts in bone marrow aspirate, total marrow blasts between 5% -25%, Non-response (NR) were assessed using modified International Working Group (IWG) response criteria for AML. Successfully (BTT) patients and successfully BTT patients (CR, CRp, or CRi) are also reported. Successfully BTT is defined as any patient who discontinued PLX3397 treatment specifically for the purpose of undergoing a hematopoietic stem cell transplant and who subsequently received the planned transplant.|1 year post dose|Efficacy analyses were conducted in the Part 2 Efficacy Population.|||Participants|||Count of Participants
2686600|NCT01349036|Secondary|Incidence (Number and Percentage of Participants) With Treatment-Emergent Adverse Events Related to Study Drug Occurring in ≥10% Participants During Treatment With PLX3397 (Safety Population)||Up to 1 year post dose|Safety events were assessed in the Safety Population.|||Participants|||Count of Participants
2686601|NCT01349036|Primary|Mean Plasma Pharmacokinetic Parameters of PLX3397 After Oral Administration of 1000 mg/Day - Cycle 1 Day 15|A noncompartmental method of analysis was used to analyze the plasma concentrations of PLX3397. Mean plasma pharmacokinetic parameters include an assessment of area under the curve over 0-6 hours (AUC0-6), and will be calculated from the Cycle 1, Day 15 values.|Pre-dose and up to 6 post dose during cycle 1, Day 15||||hr*ng/mL||Standard Deviation|Mean
2686602|NCT01349036|Primary|Mean Plasma Pharmacokinetic Parameters of PLX3397 After Oral Administration of 1000 mg/Day - Cycle 1 Day 15|A noncompartmental method of analysis was used to analyze the plasma concentrations of PLX3397. Mean plasma pharmacokinetic parameters include an assessment of area under the curve over 0-4 hours (AUC0-4), and will be calculated from the Cycle 1, Day 15 values.|Pre-dose and up to 6 post dose during cycle 1, Day 15||||hr*ng/mL||Standard Deviation|Mean
2686603|NCT01349036|Primary|Mean Plasma Pharmacokinetic Parameters of PLX3397 After Oral Administration of 1000 mg/Day - Cycle 1 Day 15|A noncompartmental method of analysis was used to analyze the plasma concentrations of PLX3397. Mean plasma pharmacokinetic parameters include maximum concentration (Cmax) and will be calculated from the Cycle 1, Day 15 values.|Pre-dose and up to 6 post dose during cycle 1, Day 15||||ng/mL||Standard Deviation|Mean
2686604|NCT01349036|Primary|Mean Plasma Pharmacokinetic Parameters of PLX3397 After Oral Administration of 1000 mg/Day - Cycle 1 Day 15|A noncompartmental method of analysis was used to analyze the plasma concentrations of PLX3397. Mean plasma pharmacokinetic parameters, include time to maximum concentration (Tmax) and will be calculated from the Cycle 1, Day 15 values.|Pre-dose and up to 6 post dose during cycle 1, Day 15||||hours||Standard Deviation|Mean
2686605|NCT01349036|Primary|Summary of Response Rates in Participants on Treatment With PLX3397|Response to treatment was evaluated using the Response Assessment in Neuro-Oncology (RANO) criteria. All participants were evaluated for progression free survival (PFS), and overall survival (OS). The six-month PFS rate was defined as the number of subjects with PFS of at least 6-month duration, with PFS measured from the first day of treatment (Cycle 1, Day 1) to the date of the first documented disease progression or date of death, whichever occurs first, over a 6-month period and evaluated using the Kaplan Meier method. The rate of OS was defined as the number of subjects that survived until study exit.|6 months post dose|Response rates were assessed in the modified intent-to-treat population.|||Participants|||Count of Participants
2686606|NCT01348854|Secondary|Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA)||6 months|Data analysis was performed for eyes treated. Subjects may have had one or both eyes treated. If both eyes, one eye may have been in Natural Astigmatism group and the other eye in the Post Cataract with Residual Astigmatism group.|||percentage of eyes|Participants||Number
2686607|NCT01348854|Primary|Reduction of Astigmatism|Reduction of astigmatism as determined by manifest refractive cylinder|6 months|Data analysis was performed for eyes treated. Subjects may have had one or both eyes treated. If both eyes, one eye may have been in Natural Astigmatism group and the other eye in the Post Cataract with Residual Astigmatism group.|||diopter|Participants|Standard Deviation|Mean
2686608|NCT01348789|Secondary|Hair Clearance|Hair Clearance = the percent of hair cleared from baseline to follow up|8 weeks after last treatment||||%baseline hair count|Participants|Standard Deviation|Median
2686609|NCT01348789|Secondary|Tolerability Level of the Procedure for Each Treatment Separately for Light and Dark Skin.|Subject self-report of the tolerability of the procedure (no pain, mild pain, moderate pain) after each of the treatments (#1, #2, #3)separately for relatively light and dark skin photo-types (I-IV and V-VI respectively according to Fitzpatrick skin photo-type classification)|0, 3, 7 days (after treatment #1, #2, and #3 respectively)||||number of areas|Participants||Number
2686610|NCT01348789|Primary|Percentage of Participants With Device Related Anticipated Skin Effects, Serious Adverse Events, or Adverse Events.|"The immediate skin reaction and long-term side and adverse effects were evaluated on site by a dermatologist. This includes the following clinical outcomes:~Presence of transient (disappearing < 24 hours) or prolonged erythema~Presence of transient (disappearing < 24 hours) or prolonged edema~Self-limited bleeding from mechanical shaving~Blister formation~Ulcer formation~Pigment changes (hypo/hyper)~Textural changes~Scarring~Infection~Pruritis~Post inflammation reactions~Allergic reaction~The safety of the device will be confirmed if no device related serious adverse event will occur."|Up to 3 months|Intention to treat analysis - all participants that received at least 1 treatment.|||percentage of particpants||95% Confidence Interval|Number
2686611|NCT01348776|Secondary|Subject Satisfaction|Gathering information about the subject satisfaction from the hair removal procedure based on 5 point satisfaction scale.|5 months (final follow up)|Two subjects did not report on satisfaction.|||participants|||Number
2686628|NCT01348542|Primary|Change in Objective Polysomnography Sleep Duration From Baseline to Follow up (9 Months)|Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and follow up (9 months)|Baseline to follow up (9 months)|From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis.|||minutes||Standard Deviation|Mean
2686612|NCT01348776|Secondary|Tolerability Level of the Procedure Following Treatments|"Gathering information about the tolerability of the procedure following weekly treatments 1, 3, 7 and maintenance treatment 3 by asking subjects to rate the tolerability of the procedure based on 5 point pain scale (no pain, mild pain, moderate pain, severe pain, Intolerable [had to stop treatment]) .~The distribution of the tolerability level is based on the analysis of the areas treated and not on the number of participants since each participant was treated on more than one area. Therefore the number of treated areas exceeds the number of participants and the unit of measurement is % treated areas that were rated."|1, 3, 7 weeks (basic weekly treatment 1, 3, and 7), and 5 months (maintenance monthly treatment#3)||||% treated areas|Participants||Number
2686613|NCT01348776|Secondary|Occurrence of Anticipated Effects on Skin|As with other IPL devices, subjects were informed that they should expect some sense of warmth, tingling, or itching, when the device was applied. This was anticipated to be mild to moderate. Subjects could also expect transient erythema and edema at the treatment site that usually disappears within 24 hours.|Up to 19 weeks||||Number of reports|Participants||Number
2686614|NCT01348776|Secondary|Hair Clearance at 3-month (Final) Follow up|Hair clearance = %hair cleared from baseline to endpoint after 7 weekly treatments with or without additional 2 monthly maintenance treatments.|5 months (3 months after 7 weekly treatments)|All areas with photos that allowed reliable hair counting were included for this analysis.|||%baseline hair count|Participants|Standard Error|Mean
2686615|NCT01348776|Primary|Hair Clearance 1 Month After Last Treatment|Hair clearance = the percent of hair cleared from baseline to endpoint.|3 months (1 month after 7 weekly treatments)|Sample size was discussed with the FDA during a pre-IDE meeting.|||%baseline hair count|Participants|Standard Deviation|Mean
2686616|NCT01348763|Secondary|Number of Participants With Changes in Haematology and Biochemistry Laboratory Tests|Haematology and biochemistry laboratory tests such as full blood count, elelectrolytes and lipids will be measured to assess for changes.|35 days|No data reported|||Participants|||Count of Participants
2686617|NCT01348763|Primary|The Ratio of the Maximum Plasma Concentration of Maraviroc Between 20 and 10 Day|On day 10 of the study the maximum concentractions of maraviroc will be measured . On day 20 of the study the maximum plasma concentractions maraviroc will be measured .|10 day, 20 days||||ratio||95% Confidence Interval|Mean
2686618|NCT01348698|Secondary|Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 6 years and 58 days||||Participants|||Count of Participants
2686619|NCT01348698|Secondary|To Analyze the Gene Expression Level Relative to Disease-free Survival and Overall Survival in Patients With Adrenocortical Carcinoma|Gene expression levels were to be analyzed relative to disease free and overall survival in patients with adrenocortical carcinoma.|5 years|Because the study was terminated due to poor accrual and all fine needle aspiration (FNA) samples were benign, molecular testing cannot be performed in the absence of cancerous tumors. Molecular testing was not done in any samples collected.||||||
2686620|NCT01348698|Primary|Determine the Accuracy of Novel Diagnostic Molecular Markers in Clinical Adrenal Fine Needle Aspiration (FNA) Biopsy and Surgically Resected Samples|Tumor tissue obtained via FNA and surgical resection were to be analyzed for molecular markers to help determine if cells were cancerous or may become cancerous.|5 years|Because the study was terminated due to poor accrual and all fine needle aspiration (FNA) samples were benign, molecular testing cannot be performed in the absence of cancerous tumors. Molecular testing was not done in any samples collected.||||||
2686621|NCT01348698|Primary|Feasibility of Molecular Testing in Adrenal Neoplasm Fine Needle Aspiration (FNA) Samples|Feasibility of molecular testing in adrenal neoplasm fine needle aspiration (FNA) samples was determined by immunohistochemistry. Ribonucleic acid and deoxyribonucleic acid was extracted from fine needle aspiration and tumor tissue samples to differentiate between normal and abnormal tissue.|5 years|Because the study was terminated due to poor accrual and all fine needle aspiration (FNA) samples were benign, molecular testing cannot be performed in the absence of cancerous tumors. Molecular testing was not done in any samples collected.||||||
2686622|NCT01348607|Secondary|Adverse Events|Adverse events assessed at all subject visits by interviews with the subject and the subject's parent/ primary caregiver.|29 days||||events|||Number
2686623|NCT01348607|Primary|Average Daytime Napping Minutes in a Week|Outcome measure was the total of daytime napping minutes in a week as assessed by participant sleep diaries|29 days||||minutes||Standard Deviation|Mean
2686624|NCT01348542|Secondary|Change From Baseline in Subjective Severity of Sleep Disturbance at 9 Months|The Insomnia Severity Index (ISI) was used to measure the change in severity of sleep disturbance at baseline to Follow Up (9 months). The ISI is composed of 7 items each rated on a scale of 0-4. The total score was calculated by adding the individual item scores. The total ISI scale score ranged from 0-28 with higher total scores indicating a higher severity of insomnia symptoms.|Baseline to follow up (9 months)|From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis.|||score on a scale||Standard Deviation|Mean
2686625|NCT01348542|Secondary|Change From Baseline in Subjective Severity of Sleep Disturbance at 3 Months|The Insomnia Severity Index (ISI) was used to measure the change in severity of sleep disturbance at baseline to post treatment (3 months). The ISI is composed of 7 items each rated on a scale of 0-4. The total score was calculated by adding the individual item scores. The total ISI scale score ranged from 0-28 with higher total scores indicating a higher severity of insomnia symptoms.|Baseline to Post Treatment (3 months)|From the 21 participants who completed the study, 15 met the criteria for objective short sleep duration and were included in the final analysis.|||score on a scale||Standard Deviation|Mean
2688189|NCT01335724|Primary|Pain on Movement|"Pain on movement on a 100 mm visual analog scale. Minimum score =0 mm no pain. Maximum score =100 mm extreme pain."|48 h||||mm||Standard Deviation|Mean
2686629|NCT01348542|Primary|Change in Objective Polysomnography Sleep Duration From Baseline to Post Treatment (3 Months)|Polysomnography (8 hours fixed time in bed) will be used to measure sleep duration at baseline and post treatment (3 months)|Baseline to Post Treatment (3 months)|Objective Short Sleepers defined by 2 week actigraphy sleep duration measurement|||minutes||Standard Deviation|Mean
2686630|NCT01348490|Secondary|Patient Global Impression of Change (PGIC) Score at Each Visit|Symptoms of myelofibrosis were assessed using the PGIC questionnaire. Using the questionnaire, patients rated the overall sense of treatment effect on their symptoms on a scale of 1 (very much improved)- 7(very much worse). The specific wording was: Since the start of the treatment you've received in this study, your myelofibrosis symptoms are: 1) Very much improved, 2) Much improved, 3) Minimally improved, 4) No change, 5) Minimally worse, 6) Much worse, 7) Very much worse. A higher score indicates worse symptoms.|Up to Week 156|Efficacy evaluable participants included all participants enrolled and treated in the study. 'Number Analyzed' is number of participants with data available at the particular time point.|||score on a scale||Standard Deviation|Mean
2686631|NCT01348490|Secondary|Percent Change From Baseline in Spleen Length Measured by Palpation|Measurement of spleen length below the left costal margin was measured by palpation at each study visit. Investigators were provided with a soft centimeter ruler so that palpable spleen length was measured in centimeters and not in finger breadths. The edge of the spleen was determined by palpation, and measured in centimeters, using a soft ruler, from the costal margin to the point of greatest splenic protrusion.|Up to Week 156|Efficacy evaluable participants included all participants enrolled and treated in the study. 'Number Analyzed' is number of participants with data available at a particular time point.|||Percentage||Standard Deviation|Mean
2686632|NCT01348490|Secondary|Change in Spleen Length Measured by Palpation|Measurement of spleen length below the left costal margin was measured by palpation at each study visit. Investigators were provided with a soft centimeter ruler so that palpable spleen length was measured in centimeters and not in finger breadths. The edge of the spleen was determined by palpation, and measured in centimeters, using a soft ruler, from the costal margin to the point of greatest splenic protrusion.|Up to Week 156|Efficacy evaluable participants included all participants enrolled and treated in the study. 'Number Analyzed' is number of participants with data available at a particular time point.|||cm||Standard Deviation|Mean
2686633|NCT01348490|Secondary|Percentage of Participants With ≥ 50% Improvement in Total Symptom Score as Measured by the Modified MFSAF V2.0 Diary at Week 24 Compared to Baseline|Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF) Version 2.0 diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), and muscle/bone pain. The total symptom score ranged from 0-60 and was calculated as the sum of the 6 symptom scores. A higher score indicates worse symptoms.|Baseline and Week 24|Efficacy evaluable participants included all participants enrolled and treated in the study.|||percentage of participants||95% Confidence Interval|Number
2686634|NCT01348490|Secondary|Percentage of Participants With ≥10% Reduction in Spleen Volume at Week 24 Compared to Baseline|MRI of the upper and lower abdomen and pelvis was performed, to assess spleen volumes. CT scan was performed if participant is not a candidate for MRI, or if MRI is not readily available. MRI was performed with a body coil. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares. The MRI (or CT scan in applicable participants) was performed on the first or second day of the baseline period (ie, Day -7 or Day -6), and the site radiologist sent the scan to the central imaging laboratory that same day. The CT scans were processed by the same central laboratory used for MRIs.|Baseline and Week 24|Efficacy evaluable participants included all participants enrolled and treated in the study.|||percentage of participants||95% Confidence Interval|Number
2686635|NCT01348490|Secondary|Percentage of Participants With ≥ 35% Reduction in Spleen Volume at Week 24 Compared to Baseline|MRI of the upper and lower abdomen and pelvis was performed, to assess spleen volumes. CT scan was performed if participant is not a candidate for MRI, or if MRI is not readily available. MRI was performed with a body coil. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares. The MRI (or CT scan in applicable participants) was performed on the first or second day of the baseline period (ie, Day -7 or Day -6), and the site radiologist sent the scan to the central imaging laboratory that same day. The CT scans were processed by the same central laboratory used for MRIs.|Baseline and Week 24|Efficacy evaluable participants included all participants enrolled and treated in the study.|||percentage of participants||95% Confidence Interval|Number
2686636|NCT01348490|Secondary|Percent Change in Total Symptom Score as Measured by the Modified MFSAF V2.0 Diary at Week 24 Compared to Baseline|Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF) Version 2.0 diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), and muscle/bone pain. The total symptom score ranged from 0-60 and was calculated as the sum of the 6 symptom scores. A higher score indicates worse symptoms..|Baseline and Week 24|ITT population included all participants enrolled and treated in the study.|||Percentage change from baseline||Standard Deviation|Mean
2686637|NCT01348490|Secondary|Percent Change in Spleen Volume at Week 24 Compared to Baseline|MRI of the upper and lower abdomen and pelvis was performed, to assess spleen volumes. CT scan was performed if participant was not a candidate for MRI, or if MRI was not readily available. MRI was performed with a body coil. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares. The MRI (or CT scan in applicable participants) was performed on the first or second day of the baseline period (ie, Day -7 or Day -6), and the site radiologist sent the scan to the central imaging laboratory that same day. The CT scans were processed by the same central laboratory used for MRIs.|Baseline and Week 24|ITT population included all participants enrolled and treated in the study.|||Percentage||Standard Deviation|Mean
2686649|NCT01348347|Primary|Maximum Tolerated Dose (MTD) of Volasertib|Maximum tolerated dose (MTD) of volasertib was the highest dose tested at which DLT was developed in not more than 1 of 6 patients in the course 1.|21 days|The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.|||mg|||Number
2686638|NCT01348490|Primary|Percentage of Participants With New Onset Grade 2 or Higher Hemorrhage as Assessed by CTCAE V4.03|"Hemorrhages were defined as any lower level terms by MedDRA included in the Standardized MedDRA Query (SMQ) for hemorrhage terms.~Participants were analyzed based on the number of subjects who received a dose within the dose group. The percentages for each column are calculated using this N. Participants who had more than 1 event in an AE category (eg, treatment-related TEAE) are counted once at each dose level the event occurred."|Up to Week 156|Safety evaluable population included participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2686639|NCT01348490|Primary|Percentage of Participants With New Onset Grade 4 Thrombocytopenia Events as Assessed by Common Terminology Criteria for Adverse Events Version 4.03 (CTCAE V4.03)|"Participants with platelet count between 50 and 100 × 10^9/L at the screening and/or baseline visit were enrolled in the study. Thrombocytopenia is defined as a condition with low blood platelet count. Grade 4 thrombocytopenia was platelet count < 25 × 10^9/L.~Participants were analyzed based on the number of subjects who received a dose within the dose group. The percentages for each column are calculated using this N. Participants who had more than 1 event in an AE category (eg, treatment-related TEAE) are counted once at each dose level the event occurred."|Up to Week 156|Safety evaluable population included participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2686640|NCT01348490|Primary|Percentage of Participants With Treatment-emergent Adverse Events (TEAE)|"TEAE was defined as adverse events that began or worsened from baseline after the first administration of the study drug.~Participants were analyzed based on the number of subjects who received a dose within the dose group. The percentages for each column are calculated using this N. Participants who had more than 1 event in an AE category (eg, treatment-related TEAE) are counted once at each dose level the event occurred."|Up to Week 156|Safety evaluable population included participants who received at least 1 dose of study drug.|||percentage of participants|||Number
2686641|NCT01348490|Primary|Percent Change From Baseline in Total Symptom Score (TSS) as Measured by the Modified Myelofibrosis Symptom Assessment Form (MFSAF) V2.0 Diary at Week 24 by Final Titrated Dose|Symptoms of myelofibrosis were assessed using a modified Myelofibrosis Symptom Assessment Form (MFSAF) Version 2.0 diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): night sweats, itching, abdominal discomfort, pain under ribs on left, feeling of fullness (early satiety), and muscle/bone pain. The total symptom score ranged from 0-60 and was calculated as the sum of the 6 symptom scores. A higher score indicates worse symptoms.|Baseline and Week 24|ITT population included all participants enrolled and treated in the study. For the 5 mg AM/ 10 mg PM arm, the t-test was not calculated due to only having a single participant.|||Percentage change from baseline||Standard Deviation|Mean
2686642|NCT01348490|Primary|Percent Change From Baseline in Spleen Volume at Week 24 by Final Titrated Dose|Magnetic resonance imaging (MRI) of the upper and lower abdomen and pelvis was performed to assess spleen volumes. Computed tomography (CT) scan was performed if participant was not a candidate for MRI or if MRI was not readily available. MRI was performed with a body coil. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares. The MRI (or CT scan in applicable participants) was performed on the first or second day of the baseline period (ie, Day -7 or Day -6), and the site radiologist sent the scan to the central imaging laboratory that same day. The CT scans were processed by the same central laboratory used for MRIs.|Baseline and Week 24|Intent-to-treat (ITT) population included all participants enrolled and treated in the study.|||Percentage change from baseline||Standard Deviation|Mean
2686643|NCT01348425|Primary|Percent Change in Stent Length Upon Deployment||During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment)||||Change in stent length (%)||Standard Deviation|Mean
2686644|NCT01348347|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 up to the Last Quantifiable Data Point (AUC0-tz) of Volasertib (BI 6727)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point (AUC0-tz) of Volasertib (BI 6727).|PK plasma samples were taken at: 5 minutes predose, 1hour, 2hours (h), 3h, 4h, 8h, 24h, 48h, 72h, 96h, 168h and 336h of course1.|The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2686645|NCT01348347|Secondary|Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) of Volasertib (BI 6727)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) of Volasertib (BI 6727).|PK plasma samples were taken at: 5 minutes predose, 1hour, 2hours (h), 3h, 4h, 8h, 24h, 48h, 72h, 96h, 168h and 336h of course1.|The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2686646|NCT01348347|Secondary|Cmax of Volasertib (BI 6727)|Maximum concentration of an analyte in plasma|Pharmacokinetic (PK) plasma samples were taken at: 5 minutes predose, 1hour, 2hours (h), 3h, 4h, 8h, 24h, 48h, 72h, 96h, 168h and 336h of course1.|The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2686647|NCT01348347|Secondary|Disease Control Rate According to RECIST v1.1|Disease control rate according to RECIST v1.1 - Unconfirmed disease control. The patients with complete response (CR), partial response (PR) or stable disease (SD).|6 months|The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.|||Participants|||Number
2686648|NCT01348347|Secondary|Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1|Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1: Unconfirmed objective response. The patients with complete response (CR) or partial response (PR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|6 months|The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.|||Participants|||Number
2706397|NCT01196741|Secondary|Median PFS||From first saracatinib/placebo dose to first documented progression and/or death, assessed up to 36 months||||months||95% Confidence Interval|Median
2686650|NCT01348347|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) in Process for the Determination of the Maximum Tolerated Dose (MTD).|"The following drug-related adverse events (AE) were defined as DLT;~Haematological toxicities: CTCAE(Common Terminology Criteria for Adverse Events) grade 4 neutropenia persisted for 7 or more days, CTCAE grade 4 thrombocytopenia or CTCAE grade 3 thrombocytopenia requiring blood transfusion.~Non-haematological toxicities: CTCAE grade ≥3 non-haematological toxicities. The following toxicity with neutropenia was defined as DLT.- CTCAE grade 3 febrile neutropenia persisted for over 2 days, Clinically significant laboratory abnormalities of CTCAE grade ≥3 persisted for over 3 days. The following laboratory abnormalities should be defined as DLT. - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): >5.0 × ULN persisted for 7 days or longer - Creatinine: >3.0 × upper limit of normal(ULN) (if the creatinine abnormality was observed even once) - Persistent electrolyte abnormality assessed by the investigator."|21 days|The treated set(TS) - All patients who received ≥1 dose of study medication (volasertib) were included in the treated set.|||Participants|||Number
2686651|NCT01348165|Primary|Assessment of Tolerability by Investigator|The investigator assessed tolerability based on adverse events and the laboratory evaluation according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'.|28 days|Treated Set|||Participants|||Number
2686652|NCT01348165|Primary|Body Temperature|Change from baseline to 28 Days in Body temperature|Baseline and 28 days|Treated Set|||degrees celcius||Standard Deviation|Mean
2686653|NCT01348165|Secondary|Minimum Effect (Emin)|Minimum effect for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production.|30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2686654|NCT01348165|Secondary|Maximum Effect (Emax)|Maximum effect for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production.|30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2686655|NCT01348165|Secondary|Area Under the Effect Curve (AUEC)|Area under the effect curve for TNF-alpha induced by LPS and LTB4 induced by fMLP. Results indicate percent change from baseline of TNF-α/LTB4 production. A positive value indicates inhibition of the production.|30 minutes (min) before drug administration and 2 hours (h), 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group. Geometric mean and geometric coefficient of variation was not calculated for any parameter in any dose group in which zero or a negative value was calculated, as geometric means cannot be calculated with negative or zero values.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2686656|NCT01348165|Secondary|Concentration of Leukotriene B4 (LTB4) Induced by N-formyl-methionine-leucine-phenylalanine (fMLP) in Whole Blood ex Vivo.|Percent of inhibition of fMLP induction of LTB4 production. Concentrations of LTB4 in plasma were determined by an enzyme-linked immunosorbent assay (ELISA). Results indicate percent change from baseline of fMLP induction of LTB4 production. A positive value indicates inhibition of the production.|0.5 hours (h) before drug administration and 2h, 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.|||percentage of LTB4 production||Standard Deviation|Mean
2686657|NCT01348165|Secondary|Concentration of Tumour Necrosis Factor-alpha (TNF-α) Induced by Lipopolysaccharide (LPS) in Whole Blood ex Vivo|Concentrations of TNF-α in plasma were determined by an enzyme-linked immunosorbent assay (ELISA). Concentrations of TNF-α in blood drawn after treatment with BI 137882 were compared with those in pre-dose samples to calculate the percent of inhibition of LPS induction of TNF-α production. Results indicate percent change from baseline of LPS-induced TNF-α production. A positive value indicates inhibition of the production.|0.5 hours (h) before drug administration and 2h, 6h, 24h and 48h after drug administration|Treated Set. Summary statistics were not calculated for the 0.5 mg group as there was only one patient in this group.|||percentage of TNF-α production||Standard Deviation|Mean
2686658|NCT01348165|Secondary|Renal Clearance of BI 137882 From the Time Point t1 Until the Time Point t2|Renal clearance of BI 137882 from the time point t1 until the time point t2 (CLR,t1-t2)|0-4, 4-8, 8-12, and 12-24 hours after drug administration|There was no measurable BI 137882 excreted in urine so this pharmacokinetic parameter was not calculated.||||||
2686659|NCT01348165|Secondary|Fraction of BI 137882 Eliminated in Urine From Time Point t1 to Time Point t2|Fraction of BI 137882 eliminated in urine from time point t1 to time point t2 (fet1-t2)|0-4, 4-8, 8-12, and 12-24 hours after drug administration|There was no measurable BI 137882 excreted in urine so this pharmacokinetic parameter was not calculated.||||||
2686660|NCT01348165|Secondary|Amount of BI 137882 Eliminated in Urine From the Time Point t1 to Time Point t2|Amount of BI 137882 eliminated in urine from the time point t1 to time point t2 (Aet1-t2)|0-4, 4-8, 8-12, and 12-24 hours after drug administration|There was no measurable BI 137882 excreted in urine so this pharmacokinetic parameter was not calculated.||||||
2686661|NCT01348165|Secondary|Apparent Volume of Distribution (Vz/F)|Apparent volume of distribution of the analyte during the terminal phase.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.|||L||Geometric Coefficient of Variation|Geometric Mean
2686662|NCT01348165|Secondary|Apparent Clearance (CL/F)|Apparent clearance of the analyte in plasma after extravascular administration.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2686714|NCT01347879|Primary|Absolute Change From Baseline in Facial Inflammatory Lesion Count (Nodules, Papules, and Pustules).||From baseline to 12 weeks after first treatment||||lesion count||Standard Deviation|Mean
2686663|NCT01348165|Secondary|Mean Residence Time (MRTpo)|Mean residence time of the analyte in the body after oral administration.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.|||hours||Geometric Coefficient of Variation|Geometric Mean
2686664|NCT01348165|Secondary|Terminal Rate Constant (λz)|Terminal rate constant in plasma.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2686665|NCT01348165|Secondary|Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)|Area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2686666|NCT01348165|Secondary|Terminal Half-life (t1/2)|Terminal half-life of BI 137882 in plasma.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.|||hours||Geometric Coefficient of Variation|Geometric Mean
2686667|NCT01348165|Secondary|Area Under the Curve 0 to Infinity (AUC0-infinity)|Area under the concentration-time curve of BI 137882 in plasma over the time interval from 0 extrapolated to infinity.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.|||nmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2686668|NCT01348165|Secondary|Time to Maximum Measured Concentration (Tmax)|Time from dosing to maximum measured concentration of the analyte in plasma.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.|||hours||Full Range|Median
2686669|NCT01348165|Secondary|Maximum Measured Concentration (Cmax)|Maximum measured concentration of BI 137882 in plasma.|30 minutes (min) before drug administration and 30min, 1 hour (h), 2h, 4h, 6h, 8h, 12h, 24h, 34h, 48h, 72h, 96h, 144h, 192h, 264h, 336h and 480h after drug administration|Treated Set. Descriptive statistics are only presented for treatment groups where the summary statistics were calculated.|||nmol/L||Geometric Coefficient of Variation|Geometric Mean
2686670|NCT01348165|Primary|Respiratory Rate (RR)|Change from Baseline to 28 Days in Respiratory rate (RR)|Baseline and 28 days|Treated Set|||breaths/min||Standard Deviation|Mean
2686671|NCT01348165|Primary|Pulse Rate (PR)|Change from Baseline to 28 Days in Pulse Rate|Baseline and 28 days|Treated Set|||bpm||Standard Deviation|Mean
2686672|NCT01348165|Primary|Blood Pressure|Change from baseline for systolic blood pressure (SBP) and diastolic blood pressure (DBP)|Baseline and 28 days|Treated Set|||mmHg||Standard Deviation|Mean
2686673|NCT01348165|Primary|Number of Subjects With Drug Related Adverse Events|Number of subjects with drug related adverse events (AEs)|From baseline up to 28 days|Treated Set which included all subjects who received one dose of trial medication|||Participants|||Number
2686674|NCT01348139|Secondary|t1/2 :Terminal Half-life|Terminal half-life (t1/2),for AZD3199 doses|0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.|PK analysis set|||Hours||Standard Deviation|Mean
2686675|NCT01348139|Secondary|Tmax:Time to Maximum Plasma Concentration|Time to maximum plasma concentration (tmax), for AZD3199 doses|0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.|PK analysis set|||Hours||Full Range|Median
2686676|NCT01348139|Secondary|AUC: Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC),|Area under the plasma concentration-time curve from zero to infinity (AUC), for AZD3199 doses|0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.|PK analysis set|||nmol*h/L||Standard Deviation|Mean
2686677|NCT01348139|Secondary|Cmax: Maximum Plasma Concentration|Maximum plasma concentration (Cmax) for AZD3199 doses|0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.|PK analysis set|||nmol/L||Standard Deviation|Mean
2686678|NCT01348139|Secondary|E0-4h: The Average of the Pulse Values Between 0 and 4 h for Every Treatment Visit|Average effect (E0-4h) of Pulse, for treatment visits 2 to 7.|0 - 4 hrs.|PD analysis set|||Beats/min||Standard Deviation|Mean
2686679|NCT01348139|Secondary|Emax: Maximum Value of Pulse for Every Treatment Visits|Peak effect (Emax) within 0-4 hours of pulse, for treatment visits 2 to 7.|0 - 4 hrs.|PD analysis set|||Beats/min||Standard Deviation|Mean
2686680|NCT01348139|Secondary|E0-24h: The Average of the FEV1 Values Between 0 and 24 h for Every Treatment Visit|Average effect over 0-24 hours of FEV1 (E0-24h), for treatment visits 2 to 7.|0 - 24 hrs|PD analysis set|||Liters||Standard Deviation|Mean
2686681|NCT01348139|Secondary|E5min: The Value of FEV1 at 5 Min for Every Treatment Visit.|Onset of effect (E5min), observed at 5 min. FEV1 for treatment visits 2 to 7.|FEV1 at 5 min|PD analysis set|||Liters||Standard Deviation|Mean
2686682|NCT01348139|Secondary|tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit|Time to peak effect (tEmax), within 0-24 hours of FEV1, for treatment visits 2 to 7.|0 - 24 hrs.|PD analysis set|||Hours||Full Range|Median
2686683|NCT01348139|Primary|E22-26h: The Average of the FEV1 Values Between 22 and 26 h for Every Treatment Visit|Trough effect (E22-26h) will be computed from the repeated measurements collected after each single dose during 22-26 hours of FEV1 from visit 2 to 7.|22-26 hrs.|PD analysis set|||Liters||Standard Deviation|Mean
2686684|NCT01348139|Primary|Emax: Maximum Value of FEV1 for Every Treatment Visits|Peak effect (Emax) within 0-24 hours of FEV1, for treatment visits 2 to 7.|0-24 hrs||||Liters||Standard Deviation|Mean
2707180|NCT01192776|Secondary|Withdrawal of Care|Number of infants for whom aggressive care is withdrawn|Birth through hospital discharge, average 22 days.||||Participants|||Count of Participants
2686685|NCT01348100|Secondary|The Average Plasma Concentration (Cav) of Iloperidone Divided by Dose - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Cav was calculated as AUC0-672h/672 h.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||ng/mL/mg||Standard Deviation|Mean
2686686|NCT01348100|Secondary|Area Under the Plasma Concentration-time Curve From 0 to the End of the Dosing Period (AUCtau) of Iloperidone - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The area under the curve was calculated using a linear trapezoidal method. The end of the dosing period was 672 hours (28 days).|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||ng*h/mL||Standard Deviation|Mean
2686687|NCT01348100|Secondary|Maximum Observed Plasma Concentration (Cmax) of Iloperidone - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||ng/mL||Standard Deviation|Mean
2686688|NCT01348100|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Iloperidone - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||hours||Full Range|Median
2686689|NCT01348100|Secondary|Duration That the Concentration of Iloperidone Was Above 4 ng/mL (Teff) - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The duration that the concentration of iloperidone was above 4 ng/mL was calculated by linear interpolation. PK/pharmacodynamic analysis performed in other studies suggests that iloperidone plasma levels of 4 ng/mL or above provide clinical efficacy.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||hours||Full Range|Median
2686690|NCT01348100|Secondary|The Average Plasma Concentration (Cav) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Cav was calculated as AUC0-672h/672 h.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||ng/mL||Standard Deviation|Mean
2686691|NCT01348100|Secondary|Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (AUClast) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The area under the curve was calculated using a linear trapezoidal method.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||ng*h/mL||Standard Deviation|Mean
2686692|NCT01348100|Secondary|Area Under the Plasma Concentration-time Curve From 0 to the End of the Dosing Period (AUCtau) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. The area under the curve was calculated using a linear trapezoidal method. The end of the dosing period was 672 hours (28 days).|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||ng*h/mL||Standard Deviation|Mean
2686693|NCT01348100|Secondary|Maximum Observed Plasma Concentration (Cmax) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||ng/mL||Standard Deviation|Mean
2686694|NCT01348100|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Iloperidone - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||hours||Full Range|Median
2686695|NCT01348100|Primary|The Average Plasma Concentration (Cav) of Iloperidone - Phase C|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. Blood samples were collected after each depot injection. PK parameters were calculated from plasma concentration-time data using non-compartmental methods. Cav was calculated as AUC0-672h/672 h.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||ng/mL||Standard Deviation|Mean
2688202|NCT01335685|Secondary|Assessments of Quality of Life (Phase 2)||Baseline, Day 1 of each treatment cycle, and Day 1 of each maintenance cycle, up to 5.5 years|Assessments of quality of life parameters were not analyzed due to change in planned analysis.||||||
2686696|NCT01348100|Primary|Maximum Observed Plasma Concentration (Cmax) of Iloperidone Divided by the Average Plasma Concentration (Cav) of Iloperidone (Cmax/Cav) - Phase B|Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.|Pre-dose to 26 days post-dose|Pharmacokinetic population: All participants with evaluable pharmacokinetic data.|||Ratio of Cmax to Cav||Standard Deviation|Mean
2686697|NCT01348087|Primary|Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs).|Adverse events were summarized for the open-label treatment period, where the open-label treatment period is defined based on how AEs were collected and reported according to the manner in which patients entered the current study and which treatment (AFQ056 or placebo) they were receiving in the previous study. AEs which were continuing from the core study or that started after the end of core study but prior to first dose of open-label study medication in the extension study for Category 1 patients are shown under ('Prior to Ext. first dose'). AEs which started during the open-label treatment period are presented based on the last AFQ056 dose taken on or before the onset date of the AE (25 mg bid; 50 mg bid; 75 mg bid; or 100 mg bid). No efficacy data presented as study was terminated|Prior to first dose in extension study, Baseline (start of study treatment in extension study) to End of trial|The analysis was performed in the safety set (SS) population, defined as participants who received at least one dose of study medication and had at least one safety assessment occurring after first dose of extension study medication. Here, 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure|||Participants|||Number
2686698|NCT01347931|Secondary|Borg Dyspnea Score|"Borg Dyspnea score is measured using a 11-point visual analog scale. The lower the score on the scale, the less breathlessness patient experiences. The score ranges from:~0 = No breathlessness at all, representing better outcome 10 = Maximum, representing worse outcome"|Measured during activity testing in a single day study visit|Per Protocol|||units on a scale||95% Confidence Interval|Median
2686699|NCT01347931|Secondary|Arterial Oxygen Saturation|O2 saturation measured by pulse oximetry|Measured during activity testing in a single day study visit|Per Protocol|||percentage of oxyHb saturation||Standard Deviation|Mean
2686700|NCT01347931|Primary|Activity Endurance Time|Time in minutes of sustained activity while using test treatments|Measured during single day study visit|Per Protocol|||minutes||Standard Deviation|Mean
2686701|NCT01347879|Secondary|Severe and Very Severe Scarring According to Scarring Score|Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe|at week 12 after first treatment|100 patients were included and 83 patients completed the study in the Visonac treatment arm. However, a few patients came back for the week 12 visit only, and have data for scarring. The total number of patients with scarring data at 12 weeks in this group is 91.|||participants|||Number
2686702|NCT01347879|Secondary|Mild and Moderate Scarring According to Scarring Score|Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe|at week 12 after first treatment|100 patients were included and 83 patients completed the study in the Visonac treatment arm. However, a few patients came back for the week 12 visit only, and have data for scarring. The total number of patients with scarring data at 12 weeks in this group is 91.|||participants|||Number
2686703|NCT01347879|Secondary|Erythema Score of Severe|Clinical assessment using a 4 point scale; none, mild, moderate, severe|2 days after first treatment|Of the 100 patients who were included in the Visonac treatment arm, 5 dropped out prior to the day 2 erythema assessment. The number of patients with erythema data at this assessment point is 95.|||participants|||Number
2686704|NCT01347879|Secondary|Erythema Score of Mild and Moderate|Clinical assessment using a 4 point scale; none, mild, moderate, severe|2 days after first treatment|Of the 100 patients who were included in the Visonac treatment arm, 5 dropped out prior to the day 2 erythema assessment. The number of patients with erythema data at this assessment point is 95.|||participants|||Number
2686705|NCT01347879|Secondary|Erythema Score of Severe|Clinical assessment using a 4 point scale; none, mild, moderate, severe|Immediately after first treatment||||participants|||Number
2686706|NCT01347879|Secondary|Percent Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)||From baseline to 12 weeks after first treatment||||percent change||Full Range|Median
2686707|NCT01347879|Secondary|Clear and Almost Clear Scarring According to Scarring Score|Clinical assessment using a 6 point scale; Clear, Almost clear, Mild, Moderate, Severe and Very severe|at week 12 after first treatment|100 patients were included and 83 patients completed the study in the Visonac treatment arm. However, a few patients came back for the week 12 visit only, and have data for scarring. The total number of patients with scarring data at 12 weeks in this group is 91.|||participants|||Number
2686708|NCT01347879|Secondary|Erythema Score of Mild and Moderate|Clinical assessment using a 4 point scale; none, mild, moderate, severe|Immediately after first treatment||||participants|||Number
2686709|NCT01347879|Secondary|Number of Patients With Adverse Events.||From administration of investigational medicinal product (IMP) until 12 weeks after first IMP administration||||participants|||Number
2686710|NCT01347879|Secondary|Pain During Illumination.|Pain during illumination was assessed by patient using a Visual Analogue Scale (VAS) from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.|Immediately after first treatment||||VAS score in cm||Full Range|Mean
2686711|NCT01347879|Secondary|Proportion of Patients With Success According to IGA Scale Based on the Facial Assessment.|One Investigator Global Assessment (IGA) scale was used including inflammatory and non-inflammatory lesions. The investigator qualitatively graded the overall acne severity on a scale from 0 to 4, with 4 being the most severe. Success was defined as an improvement of at least 2 grades from the baseline score.|From baseline to 12 weeks after first treatment||||participants|||Number
2686712|NCT01347879|Secondary|Percent Change From Baseline in Facial Inflammatory (Nodules, Papules, and Pustules)Lesion Counts.||From baseline to 12 weeks after the first treatment||||percent change||Full Range|Median
2686713|NCT01347879|Secondary|Absolute Change From Baseline in Facial Non-inflammatory Lesion Count (Open and Closed Comedones)||From baseline to 12 weeks after the first treatment||||lesion count||Standard Deviation|Mean
2686715|NCT01347866|Secondary|Duration of Response (Stage 2)|Duration of response was to be calculated for participants with an objective response. Duration of PR or CR was the time from start date (date of first documentation of PR or CR) to date of first documentation of objective progression or death. CR: disappearance of a target lesions. PR: at least 30% decrease in the sum of diameters of target lesions.|Baseline, every 8 weeks in Cycle 3 and subsequent cycles, until until progression of disease was documented.|There was only 1 participant in Arm C1 and 1 in Arm C2 with a response, therefore summary statistics were not calculated for this endpoint.||||||
2686716|NCT01347866|Secondary|Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling|Number of participants with expression of genes relating to PI3K, MAPK and/or Wnt pathway signaling (kirsten rat sarcoma 2 viral oncogene homolog [KRAS] and PTEN protein). Biopsies were obtained at baseline and Cycle 1 Day 23. Biomarker evaluation was performed on these biopsies.|Baseline and Cycle 1 Day 23.|All enrolled participants who started treatment and had baseline tumor tissues successfully analyzed for at least one of the biomarkers.|||participants|||Number
2686717|NCT01347866|Secondary|Ratio to Baseline in Serum Insulin Level at Cycle 2 Day 16 for Arm A||Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)|All enrolled participants who started treatment and had baseline and on treatment serum biomarker samples (glucose, insulin, or other serum biomarkers) successfully analyzed for at least one of the biomarkers.|||ratio||Standard Deviation|Mean
2686718|NCT01347866|Secondary|Ratio to Baseline in Serum Glucose Level at Cycle 2 Day 16 for Arm A||Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)|All enrolled participants who started treatment and had baseline and on treatment serum biomarker samples (glucose, insulin, or other serum biomarkers) successfully analyzed for at least one of the biomarkers.|||ratio||Standard Deviation|Mean
2686719|NCT01347866|Secondary|Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D||Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)|All enrolled participants who started treatment and had baseline and on treatment serum biomarker samples (glucose, insulin, or other serum biomarkers) successfully analyzed for at least one of the biomarkers.|||ratio||Standard Deviation|Mean
2686720|NCT01347866|Secondary|Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D||Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)|All enrolled participants who started treatment and had baseline and on treatment serum biomarker samples (glucose, insulin, or other serum biomarkers) successfully analyzed for at least one of the biomarkers.|||ratio||Standard Deviation|Mean
2686721|NCT01347866|Secondary|Progression-Free Survival (PFS) (Stage 2)|Progression-free survival (PFS) was the time from first dose to date of first documentation of progression or death due to any cause.|Baseline, every 8 weeks in Cycle 3 and subsequent cycles, until progression of disease was documented.|All participants who started treatment on the assigned arm and had an adequate baseline tumor assessment.|||months||95% Confidence Interval|Median
2686722|NCT01347866|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR)|CR was defined as the disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis <10 mm). PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions.|Baseline, every 8 weeks in Cycle 3 and subsequent cycles, until progression of disease was documented.|All participants who started treatment on the assigned arm and had an adequate baseline tumor assessment.|||percentage of participants|||Number
2686723|NCT01347866|Secondary|Number of Participants With Maximum Post-dose QT Interval Corrected|Electrocardiogram (ECG) measurements (an average of the triplicate measurements) were used for the statistical analysis and all data presentations. QT intervals were corrected for heart rate (QTc) using Bazett's Formula (QTcB) and Fridericia's Formula (QTcF).|Baseline, Cycle 1 Day 2 for Arms C and D, Cycle 1 Day 15 for Arm D, and Cycle 1 Day 16 for Arm C, Day 2 in Arm C and Day 1 in Arm D for subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)|All participants enrolled in the study having at least one ECG assessment after receiving study drug for the respective arm.|||participants|||Number
2686724|NCT01347866|Secondary|Number of Participants With Increase From Baseline in QT Interval|Electrocardiogram (ECG) measurements (an average of the triplicate measurements) were used for the statistical analysis and all data presentations. QT intervals were corrected for heart rate (QTc) using Bazett's Formula (QTcB) and Fridericia's Formula (QTcF) .|Baseline, Cycle 1 Day 2 for Arms C and D, Cycle 1 Day 15 for Arm D, and Cycle 1 Day 16 for Arm C, Day 2 in Arm C and Day 1 in Arm D for subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)|All participants enrolled in the study having at least one ECG assessment after receiving study drug for the respective arm.|||participants|||Number
2686725|NCT01347866|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-04691502 on Cycle 0 Day -7 for Arm B||Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2686726|NCT01347866|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-04691502 on Cycle 0 Day -7 for Arm A||Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2686727|NCT01347866|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PD-0325901 on Cycle 0 Day -7 for Arm A||Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2691339|NCT01311024|Secondary|Carriage Due to Any Pneumococcal Serotype|Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age|one sampling at 3 to 7 years of age|||||||
2686728|NCT01347866|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D||Cycle 0 Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2686729|NCT01347866|Secondary|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C||Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2686730|NCT01347866|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-04691502 on Cycle 0 Day -7 for Arm B||Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2686731|NCT01347866|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-04691502 on Cycle 0 Day -7 for Arm A||Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2686732|NCT01347866|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PD-0325901 on Cycle 0 Day -7 for Arm A||Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2686733|NCT01347866|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D||Cycle 0 Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2686734|NCT01347866|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C||Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2686735|NCT01347866|Secondary|Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B||Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.|||hr||Standard Deviation|Mean
2686736|NCT01347866|Secondary|Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A||Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.|||hr||Standard Deviation|Mean
2686737|NCT01347866|Secondary|Terminal Elimination Half Life (t½) for PD-0325901 on Cycle 0 Day -7 for Arm A||Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose.|Enrolled participants treated who had at least 1 of the pharmacokinetic (PK) parameters of interest estimated.|||hr||Standard Deviation|Mean
2686738|NCT01347866|Secondary|Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D||Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.|||hr||Standard Deviation|Mean
2686739|NCT01347866|Secondary|Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C||Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.|||hr||Standard Deviation|Mean
2686740|NCT01347866|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B||Cycle 0 Day -7 at 0 hours (pre-dose) and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6 8 and 24 hours post-dose.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.|||hr||Full Range|Median
2686741|NCT01347866|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A||Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.|||hr||Full Range|Median
2686742|NCT01347866|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A||Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.|||hr||Full Range|Median
2686743|NCT01347866|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D||Cycle 0 Day -1 and Cycle 1 Day 1: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.|||hr||Full Range|Median
2687792|NCT01339000|Secondary|Evaluate the Effects of Interleukin-7 (CYT107) Therapy on the Quality of T Cell Specific Responses by Multiparameter Flow Cytometry||8 weeks|Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.||||||
2686744|NCT01347866|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D||Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.|||hr||Full Range|Median
2686745|NCT01347866|Secondary|Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C||Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.|||hour (hr)||Full Range|Median
2686746|NCT01347866|Secondary|Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B||Cycle 0 Day -7 at 0 hours (pre-dose) and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6 8 and 24 hours post-dose.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.|||ng/mL||Standard Deviation|Mean
2686747|NCT01347866|Secondary|Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A||Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2686748|NCT01347866|Secondary|Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A||Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2686749|NCT01347866|Secondary|Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D||Cycle 0 Day -1 and Cycle 1 Day 1: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2686750|NCT01347866|Secondary|Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D||Cycle 0 Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.|Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2686751|NCT01347866|Secondary|Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C||Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.|Enrolled participants treated who had at least 1 of the pharmacokinetic (PK) parameters of interest estimated. N=number of participants contributing to the summary statistics.|||nanogram (ng)/milliliter (mL)||Geometric Coefficient of Variation|Geometric Mean
2686752|NCT01347866|Secondary|Number of Participants With Vital Signs Values Meeting Prespecified Criteria|Number of participants with vital signs values meeting prespecified criteria. Criteria defined as: 1) absolute systolic blood pressue (SBP) less than or equal to (<=) 100 millimeter of mercury (mmHg); 2) absolute SBP greater than or equal to (>=) 160 mmHg, 3) SBP maximum increase of >=20 mmHg from baseline; 4) SBP maximum increase of >=40 mmHg from baseline; 5) SBP maximum increase of >=60 mmHg from baseline; 6) absolute diastolic blood pressure (DBP) <=60 mmHg; 7) absolute DBP >=100 mmHg; 8) DBP maximum increase of >=10 mmHg from baseline; 9) DBP maximum increase of >=20 mmHg from baseline; 10) DBP maximum increase of >=30 mmHg from baseline; 11) absolute heart rate (HR) <50 beats per minute (bpm); 12) absolute HR >120 bpm.|Baseline, Days 1, 15, and 23 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)|All enrolled participants who started treatment. N=number of participants evaluated against criteria.|||participants|||Number
2686753|NCT01347866|Secondary|Number of Participants With Laboratory Test Abnormalities (Urinalysis)|Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 urinalysis test abnormalities for urine protein.|Baseline, Days 1 and 15 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)|All enrolled participants who started treatment. Number of participants analyzed=number of evaluable participants for each laboratory parameter.|||participant|||Number
2686754|NCT01347866|Secondary|Number of Participants With Laboratory Test Abnormalities (Chemistry)|Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry test abnormalities. Chemistry tests included aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]), serum creatinine, total bilirubin, direct/indirect bilirubin, alkaline phosphatase, chloride, uric acid, phosphorus, calcium, magnesium, potassium, sodium, blood urea nitrogen (BUN) or urea, total protein, albumin, glucose, and insulin.|Baseline, Days 1, 15, and 23 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)|All enrolled participants who started treatment.|||participant|||Number
2686755|NCT01347866|Secondary|Number of Participants With Laboratory Test Abnormalities (Coagulation)|Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 coagulation test abnormalities. Coagulation tests included partial thromboplastin time (PTT) and prothrombin time (PT) international normalized ratio (INR).|Baseline, Days 1 and 15 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)|All enrolled participants who started treatment. N=number of evaluable participants for each parameter.|||participant|||Number
2686756|NCT01347866|Secondary|Number of Participants With Laboratory Test Abnormalities (Hematology)|Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities. Hematological tests included platelet count, hemoglobin, and white blood cell (WBC) count with 5- part differential.|Baseline, Days 1, 15, and 23 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)|All enrolled participants who started treatment.|||participant|||Number
2686757|NCT01347866|Secondary|Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded by the NCI CTCAE (Version 4.0).|Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration)|All enrolled participants who started treatment.|||participants|||Number
2686758|NCT01347866|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration)|All enrolled participants who started treatment.|||participants|||Number
2686759|NCT01347866|Primary|Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days)|DLT was defined as any of the following hematologic or non-hematologic events which were attributable to the combination study drug and occurring in the first 28-day cycle: 1) Grade 4 neutropenia lasting greater than (>)7 days; 2) Febrile neutropenia (defined as neutropenia greater than or equal to [≥]Grade 3 and a body temperature ≥38.5°C); 3) Grade ≥3 neutropenic infection; 4) Grade 3 thrombocytopenia with bleeding; 5) Grade 4 thrombocytopenia; 6) Grade ≥3 toxicities; 7) Persistent, intolerable toxicities which resulted in failure to deliver at least 75% of doses during the first cycle; 8) Persistent, intolerable toxicities which resulted in delay of start of Cycle 2 by more than 2 weeks of scheduled day; 9) Persistent Grade 3 QTc prolongation (QTc >500 msec) after correction of any reversible causes.|Baseline up to 28 days|All enrolled participants who started treatment and who did not have a major pre-specified treatment deviation in the first cycle of treatment in Stage 1.|||percentage of participants|||Number
2686760|NCT01347840|Secondary|Percent Weight Loss|(Weight at Baseline - Weight at Each Visit) divided by the (Weight at Baseline).|16 Months||||percentage of weight loss|||Number
2686761|NCT01347840|Secondary|Body Mass Index|Will be calculated at Screening, Visit 3, Visit 5, Visit 6, Visit 8, and Visit 10.|16 Months||||units on a scale|||Number
2686762|NCT01347840|Secondary|Hemoglobin A1c and Lipid Panel|These laboratory values will be collected at Screening, Visit 8, and Visit 10.|16 months||||units on a scale|||Number
2686763|NCT01347840|Secondary|Area Under the Curve of Glucose|This variable will measure the combined effects of glucose concentration and duration.|16 months||||units on a scale|||Number
2686764|NCT01347840|Secondary|Subject Questionnaires|The subscales and total scores as set out in the scoring algorithms for Food Craving Inventory-II and Questionnaire on Craving for Sweet and Rich Foods will be presented.|16 months||||participants|||Number
2686765|NCT01347840|Secondary|Adiponectin and Lectin|These laboratory values will be collected at Visit 3, Visit 5, Visit 6, and Visit 10.|16 months||||units on a scale|||Number
2686766|NCT01347840|Secondary|Area Under the Curve of Timed Gastrointestinal Hormones (Insulin, GIP, Pancreatic Polypeptide, Peptide YY (PYY), Amylin, Glucagon, Pro-Insulin, C-Peptide)|These variables will measure the combined effects of hormone concentration and duration.|16 months||||units on a scale|||Number
2686767|NCT01347840|Primary|Area Under the Curve of Ghrelin and GLP-1|These variables will measure the combined effects of hormone concentration and duration.|16 months||||units on a scale|||Number
2686768|NCT01347840|Primary|Resting Energy Expenditure|Energy expended at rest (minimal movement) and during fasting. Resting Energy Expenditure can be expressed per minute or per hour or per day.|16 months||||units on a scale|||Number
2686769|NCT01347840|Primary|Percent Excess Weight Loss|Calculated as the difference between the baseline weight and weight at endpoint divided by the difference between baseline weight and ideal body weight using the medium frame range in the Metropolitan Tables for Life Insurance, 1983 x 100.|16 months||||percentage of excess weight|||Number
2686770|NCT01347788|Primary|Partial Response in Bone Scan From Baseline to Week 6|Bone scans will be centrally reviewed and categorized based on comparison of week 6 and baseline imaging. Partial response is defined as 30% or greater decrease in bone scan lesion area from baseline to week 6. An adaptive response design to determine the lowest effective cabozantinib dose among three dose levels (dose level +1, dose level 0 and dose level +1) will be employed.|Baseline and Week 6||||participants|||Number
2686771|NCT01347762|Secondary|Change From Baseline in Neuropsychological Performance at 10 Weeks|performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner|baseline and 10 weeks|Due to funding and the principal investigator's change in institutions, this data was not analyzed and is no longer available to the investigator.||||||
2686772|NCT01347762|Secondary|Change From Baseline Cannabis Use at 14 Weeks|quantitative urine screens - Comparing the THC-COOH to creatinine ratio at baseline and at the end of the study (Week 14)|baseline and 14 weeks|Fewer participants had their THC:creatinine ratios analyzed than were randomized due to a high number of subject drop-out. Any subject who dropped out before completing the 10 weeks of treatment were not analyzed using this measure.|||Ratio||Standard Deviation|Mean
2686773|NCT01347762|Secondary|Change From Baseline Neuropsychological Performance at 4 Weeks|performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner|baseline and 4 weeks|Due to funding and the principal investigator's change in institutions, this data was not analyzed and is no longer available to the investigator.||||||
2686774|NCT01347762|Primary|Number of Marijuana Inhales Per Day|Average # of marijuana inhales per day during baseline compared to after 10 weeks of treatment.|Week 10|"Fewer participants had their average number of inhales per day analyzed than were randomized due to a high number of subject drop-out. Any subject who dropped out before completing the 10 weeks of treatment were not analyzed using this measure."|||Inhales per day||Standard Deviation|Mean
2686810|NCT01347255|Secondary|Changes in Total Clinical Score (TCS) by Visit|Change in Total Clinical Score (TCS; range from 0 (all signs absent) to 9 (all signs severe)) at individual visits (Days 4, 8, 11, 15, 22, and 25) compared to baseline.|Baseline and Days 4, 8, 11, 15, 18, 22, 25||||Scores on a scale||Standard Deviation|Mean
2686775|NCT01347762|Primary|Change From Baseline in Cannabis Use at 10 Weeks|Quantitative cannabis urine screens (THC-COOH:Creatinine ratio)|baseline and 10 weeks|Fewer participants had their THC:creatinine ratios analyzed than were randomized due to a high number of subject drop-out. Any subject who dropped out before completing the 10 weeks of treatment were not analyzed using this measure.|||Ratio||Standard Deviation|Mean
2686776|NCT01347710|Secondary|Diagnostic Certainty in PET MPI and SPECT MPI|Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography|||proportion of patients|||Number
2686777|NCT01347710|Secondary|Image Quality of Rest and Stress (PET vs SPECT).|Overall summary of rest and stress image quality for flurpiridaz F18 PET MPI and SPECT MPI by majority rule. Value represents the number of subject images evaluated as excellent/good and fair/poor|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography|||percent of images|||Number
2686778|NCT01347710|Secondary|Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good|Overall summary of specificity of flurpiridaz F18 PET MPI (qualitative, image quality excellent or good) vs. SPECT MPI by majority rule vs truth standard (angio >/=50% stenosis and confirmed MI). Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography|||proportion of true negatives||95% Confidence Interval|Number
2686779|NCT01347710|Primary|Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity|Diagnostic efficacy of flurpiridaz PET MPI specificity versus SPECT MPI specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard|60 days|all safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data and had evaluable invasive coronary angiography|||Proportion of true negatives||95% Confidence Interval|Number
2686780|NCT01347710|Secondary|Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good|Overall summary of sensitivity of flurpiridaz F18 PET MPI (qualitative image quality of excellent or good) vs. SPECT MPI by majority rule vs. truth standard(angio >/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography|||proportion of true positives||95% Confidence Interval|Number
2686781|NCT01347710|Secondary|Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).|Overall summary of specificity for identifying multi-vessel disease between flurpiridaz F18 PET MPI and SPECT MPI by majority rule vs. majority rule (angio >/=50% stenosis and confirmed MI). Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography|||proportion of true negatives||95% Confidence Interval|Number
2686782|NCT01347710|Secondary|Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).|Overall summary of sensitivity for identifying multi-vessel disease between flurpiridaz F18 PET MPI and SPECT MPI by majority rule vs. truth standard (angio >/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography|||proportion of true positives||95% Confidence Interval|Number
2686783|NCT01347710|Secondary|Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).|Overall specificity of flurpiridaz F18 PET MPI in Coronary Territories (Qualitative Diagnosis) vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography|||proportion of true negatives||95% Confidence Interval|Number
2686784|NCT01347710|Secondary|Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).|Overall sensitivity of flurpiridaz F18 PET MPI in coronary territories (Qualitative Diagnosis vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 Flurpiridaz F18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography|||Proportion of true positives||95% Confidence Interval|Number
2686785|NCT01347710|Secondary|Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.|Diagnostic efficacy of flurpiridaz F18 PET MPI specificity versus SPECT specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, in subgroups: pharmacologic stress, females and BMI >/=30. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard|60 days|all safety evaluable patients who had a rest and stress flurpiridaz F18 PET MPI and SPECT MPI procedures resulting in evaluable data and evaluable invasive coronary angiography|||proportion of true negatives||95% Confidence Interval|Number
2686888|NCT01346514|Secondary|Treatment Process Measures (Number of Treatment Sessions, Type of Housing Placement, and Change in Life Skills)|Analyses will explore whether treatment process variables mediate differences in outcomes between Addiction/Housing Case Management and time and attention conditions.|Baseline to 12 months|Due to the lack of differences seen in the primary housing outcomes between the AHCM and HSG conditions, tests of mediation were not completed.||||||
2686786|NCT01347710|Secondary|Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.|"Diagnostic efficacy of flurpiridaz F18 PET MPI sensitivity versus SPECT MPI sensitivity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, , in subgroups: pharmacologic stress, females and BMI >/=30. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard~I"|60 days|all safety evaluable patients who had a rest and stress flurpiridaz F18 PET MPI and SPECT MPI procedures resulting in evaluable data and evaluable invasive coronary angiography|||proportion of true postives||95% Confidence Interval|Number
2686787|NCT01347710|Primary|Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity|Diagnostic efficacy of one day rest and stress flurpiridaz F 18 PET MPI sensitivity versus SPECT MPI sensitivity in the detection of coronary artery disease (CAD) by majority rule using invasive coronary angiography as the truth standard,|60 days|All safety evaluable patients who had rest and stress flurpiridaz F 18 PET MPI and SPECT MPI procedures resulting in evaluable data, and had evaluable invasive coronary angiography|||Proportion of true positive cases||95% Confidence Interval|Number
2686788|NCT01347632|Primary|p24 Antigen Production at Baseline Versus After Treatment With Metronidazole|p 24 antigen data was not evaluable in this study due to the fact that the samples were frozen prior to laboratory analyses.|30 days|||||||
2686789|NCT01347632|Primary|p24 Antigen Production in Tissue|"The study will evaluate HIV infection and safety of cervico-vaginal tissue in women at 3 different time periods:~During a BV infection~Approximately 1 week after completing a 7-day course of metronidazole therapy~Approximately 1 month after completing the 7-day course of metronidazole therapy~Each of the 33 participants were sampled at baseline (during BV infection), approximately 1 week after treatment and approximately 1 month after treatment. p 24 antigen data was not evaluable in this study due to the fact that the samples were frozen prior to laboratory analyses, which damaged the samples. No data were collected."|6 weeks|||||||
2686790|NCT01347580|Secondary|Minor and Major Bleeds After 48 Hours|non CABG related bleeds (PLATO definition)|after 48 hours post first dose|safety|||patients|||Number
2686791|NCT01347580|Secondary|Major Bleeds After 48 Hours|non CABG related bleeds (PLATO definition) include life threatening and other major bleedings|after 48hours post-first dose|safety|||patients|||Number
2686792|NCT01347580|Secondary|Minor and Major Bleedings Within 48 Hours|non CABG related bleeds (PLATO definition)|within 48 hours of first dose|Safety|||patients|||Number
2686793|NCT01347580|Secondary|Major Bleeds Within 48 Hours|non CABG related bleeds, (PLATO definition) include Life threatening and other major bleeds|within 48 hours of first dose|Safety|||patients|||Number
2686794|NCT01347580|Secondary|Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI|Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention.|during PCI|mITT|||patients|||Number
2686795|NCT01347580|Secondary|ST Segment Elevation Resolution Post-PCI >= 70%|ST segment elevation resolution post PCI >=70% is defined as complete resolution|Between baseline and ECG 60 mn post-PCI|mITT on patients with non missing ECG values|||patients|||Number
2686796|NCT01347580|Secondary|TIMI Flow Grade 3 Post -PCI|TIMI) flow grade 3 is complete perfusion post-PCI.|at coroangiography post-PCI|mITT, on patients with non missing TIMI flow grade values|||patients|||Number
2686797|NCT01347580|Secondary|Definite Stent Thrombosis|Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. It is an adjudicated endpoint|during 30 days of treatment|mITT|||patients|||Number
2686798|NCT01347580|Secondary|2nd Composite Clinical Endpoint|Death/MI/urgent revascularization. Adjudicated events except death|within 30 days of study|mITT|||patients|||Number
2686799|NCT01347580|Secondary|1st Composite Clinical Endpoint|death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death|during the 30 days of treatment|mITT|||patients|||Number
2686800|NCT01347580|Primary|ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)|ST segment elevation resolution is the mean ST elevation pre-hospital minus the mean STelevation pre-PCI divided by the mean ST elevation pre-hospital. It is expressed as a percentage and split in 2 categories , complete (≥70%) versus incomplete (<70%) resolution.|Between baseline and PCI|mITT, on patients with non missing values|||patients|||Number
2686801|NCT01347580|Primary|Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)|(TIMI) flow grade classification is used to assess coronary blood flow in acute coronary syndromes. grade 0:no reperfusion, grade 1: penetration without perfusion, grade 2: Partial reperfusion, grade 3: complete perfusion.|At initial angiography, pre PCI|mITT, on patients with non missing values|||patients|||Number
2686802|NCT01347554|Secondary|Any Bleeding||Two year||||participants|||Number
2686803|NCT01347554|Secondary|Stent Thrombosis|Definite and probable stent thrombosis|Two years||||participants|||Number
2686804|NCT01347554|Secondary|Device-oriented Composite Outcome|defined as a composite of all-cause mortality, any MI (includes non-target vessel territory) and repeat revascularization (includes all target and non-target vessel)|Two years||||participants|||Number
2686805|NCT01347554|Primary|Device-oriented Composite Outcome|defined as a composite of cardiac death, Myocardial infarction not clearly attributable to a nontarget vessel and target lesion revascularization|Two year||||participants|||Number
2686806|NCT01347333|Secondary|Late Complication Rates|Toxicities will be assessed using CTCAE grading criteria at specified timepoints.|5 years|This outcome was not collected.||||||
2686807|NCT01347333|Primary|Local Tumor Recurrence Rate|Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume.|5 years|No patients enrolled into primary liver tumor group.|||Participants|||Count of Participants
2686808|NCT01347255|Secondary|Changes in Total Skin Thickness|Change in total skin thickness measured by ultrasound at end of treatment (Day 29) and individual visits (Days 8, 15, and 22) compared to baseline|Baseline and Days 8, 15, 22, and 29.||||millimetres||Standard Deviation|Mean
2686809|NCT01347255|Secondary|Change From Baseline in Echo-poor Band Thickness at End of Treatment|Change in echo-poor band thickness from baseline to end of treatment, measured by ultrasound|Baseline and Day 29||||millimetres||Standard Deviation|Mean
2686811|NCT01347255|Secondary|Change in Clinical Sign Scores|"Absolute change in score of each clinical sign (erythema, scaling, infiltration) at end of treatment (Day 29) and at individual visits (Days 4, 8, 11, 15, 18, 22, and 25) compared to Baseline.~The investigator assessed the severity of the clinical signs erythema, scaling, and infiltration for each test site by using a 7-point scale (range 0 (no evidence) to 3 (severe)).~Negative changes in mean score represent improvement."|Baseline and Days 4, 8, 11, 15, 18, 22, 25, and 29 (End of Treatment)||||units on a scale||Standard Deviation|Mean
2686812|NCT01347255|Primary|Absolute Change in Total Clinical Score (TCS) of Clinical Signs (Sum of Erythema, Scaling and Infiltration) at End of Treatment Compared to Baseline|TCS range from 0 (all signs absent) to 9 (all signs severe).|Day 1 (Baseline)/Day 29|Intra-individual analysis population|||Scores on a scale||Standard Deviation|Mean
2686813|NCT01347112|Secondary|Heavy Drinking Days at End of Treatment|Heavy drinking is defined as 5 standard alcohol drinks or greater for men and 4 standard alcohol drinks or greater for women. The number of heavy drinking days per month was determined using the timeline follow-back method.|week 12||||days||Standard Deviation|Mean
2686814|NCT01347112|Secondary|Prolonged Abstinence at 24 Weeks|"Prolonged abstinence is identified by a negative response to the question, Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?"|week 24||||participants|||Number
2686815|NCT01347112|Primary|Prolonged Smoking Abstinence at End of 12 Weeks of Varenicline Treatment|"Prolonged smoking abstinence will be identified by a negative response to the question, Since 2 weeks after your TQD, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?"|12 weeks||||participants|||Number
2686816|NCT01347086|Secondary|Cmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)|"Maximum measured concentration of the analyte in plasma (CD 6168 Acylglucuronide).~The descriptive statistics of the arm Chinese 400mg cannot be determined due to limitation of available data above the below limit of quantification (BLQ)."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||µmol/L||Geometric Coefficient of Variation|Geometric Mean
2686817|NCT01347086|Secondary|Tmax of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)|"Time from dosing to the maximum measured concentration of the analyte in plasma (CD 6168 Acylglucuronide). The descriptive statistics of the arm Chinese 400mg cannot be determined due to limitation of available data above the below limit of quantification (BLQ)."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||h||Full Range|Median
2686818|NCT01347086|Secondary|AUC0-∞ of CD 6168 Acylglucuronide (Metabolite of Deleobuvir)|"Area under the concentration-time curve of the analyte in plasma (CD 6168 Acylglucuronide) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms Japanese 400mg, Japanese 800mg, Japanese 1200mg and Chinese 400mg cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||µmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2686819|NCT01347086|Secondary|Cmax of CD 6168 (Metabolite of Deleobuvir)|Maximum measured concentration of the analyte in plasma (CD 6168).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||µmol/L||Geometric Coefficient of Variation|Geometric Mean
2686820|NCT01347086|Secondary|Tmax of CD 6168 (Metabolite of Deleobuvir)|Time from dosing to the maximum measured concentration of the analyte in plasma (CD 6168).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||h||Full Range|Median
2686821|NCT01347086|Secondary|AUC0-∞ of CD 6168 (Metabolite of Deleobuvir)|"Area under the concentration-time curve of the analyte in plasma (CD 6168) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms Japanese 1200mg and Chinese 400mg cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||µmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2686822|NCT01347086|Secondary|Cmax of BI 208333 (Metabolite of Deleobuvir)|Maximum measured concentration of the analyte in plasma (BI 208333).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||µmol/L||Geometric Coefficient of Variation|Geometric Mean
2686823|NCT01347086|Secondary|Tmax of BI 208333 (Metabolite of Deleobuvir)|Time from dosing to the maximum measured concentration of the analyte in plasma (BI 208333) .|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||h||Full Range|Median
2686824|NCT01347086|Secondary|AUC0-∞ of BI 208333 (Metabolite of Deleobuvir)|"Area under the concentration-time curve of the analyte in plasma (BI 208333) over the time interval from 0 extrapolated to infinity. The descriptive statistics of the arms Japanese 400mg, Japanese 800mg and Chinese 400mg cannot be determined. The reason was that there were too few data to derive a terminal elimination rate constant (slope) to calculate AUC0-∞."|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||µmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2686825|NCT01347086|Secondary|Cmax of Deleobuvir|Maximum measured concentration of the analyte in plasma (Deleobuvir).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||µmol/L||Geometric Coefficient of Variation|Geometric Mean
2686826|NCT01347086|Secondary|Tmax of Deleobuvir|Time from dosing to the maximum measured concentration of the analyte in plasma (Deleobuvir).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h after drug administration|The PK analysis set.|||h||Full Range|Median
2687015|NCT01345630|Secondary|Number of Participants With Grade 3 or 4 AEs|Number of participants with grade 3 or 4 AEs are presented here.|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.|||participants|||Number
2686827|NCT01347086|Secondary|AUC0-∞ of Deleobuvir|Area under the concentration-time curve of the analyte in plasma (Deleobuvir) over the time interval from 0 extrapolated to infinity (AUC0-∞).|-2:00, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 5:00, 6:00, 8:00, 10:00, 12:00, 24:00, 36:00, 48:00 h (hours) after drug administration|The pharmacokinetic (PK) analysis set: all evaluable subjects of the treated set who provided at least 1 observation for at least 1 PK endpoint without important protocol violations relevant to the evaluation of PK.|||µmol*h/L||Geometric Coefficient of Variation|Geometric Mean
2686828|NCT01347086|Primary|Number of Subjects With Adverse Events as Determined by Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinanalysis and ECG|"Clinical relevant abnormalities for vital signs, blood chemistry, haematology, urinanalysis and ECG. Tolerability assessment endpoint.~New abnormal findings or worsening of baseline conditions were reported as adverse events. Adverse events were assessed through the entire trial, from signing the informed consent (within 21 days before drug administration) onwards through the observational phase until the end-of-trial-examination (within 14 days after last trial procedure)."|From signing the informed consent (within 21 days before drug administration) until 14 days after end of trial visit, upto 38 days.|The treated set.|||participants|||Number
2686829|NCT01347086|Primary|Number of Subjects With Drug Related Adverse Events|"Number of subjects with investigator-defined drug-related adverse events (AEs). Tolerability assessment endpoint.~The investigator assessed the possible causal relationship between all AEs and the investigational drug, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, and confounding factors such as concomitant medication, concomitant diseases, and relevant history."|From first administration of study drug (drug related AEs) until 14 days after end of trial visit, upto 17 days.|Treated set (full analysis set according to the International Conference on Harmonization (ICH) E9 guideline): all subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.|||Participants|||Number
2686830|NCT01347073|Primary|Adverse Events|Rate of adverse events during the Safety Extension portion of the protocol ( please note: HPN-100 treatment only during Safety Extension )|12 months|All patients that entered the Safety Extension were included in the analysis of adverse events|||participants|||Number
2686831|NCT01347073|Secondary|Hyperammonemic Crisis|Rate of HAC during pre-enrollment on NaPBA compared to HAC during HPN-100 treatment|1 year||||number of crises|||Number
2686832|NCT01347073|Secondary|Frequency of Ammonia Levels Greater Than the Upper Limit of Normal (ULN) on HPN-100 Compared With NaPBA|Ammonia values were converted to SI units (umol/L) and normalized to a standard ULN of 35 umol/L prior to analysis|2 weeks|All patients who received any amount of both study medications (NaPBA and HPN-100) were included in this population, which is the primary population for analysis of efficacy and pharmacokinetic parameters.|||Ammonia Values > ULN|Ammonia Values||Number
2686833|NCT01347073|Secondary|Blood Ammonia|24-hour ammonia AUC of blood ammonia levels on Days 1 (NaPBA) and 10 (HPN-100) were compared. Ammonia was assessed at Hour 0 (pre-first dose, fasted), Hour 8 (~2-4 hours after lunch or the second main meal and dose of NaPBA), Hour 12 (~4 hours after the last main meal) and 24 hours post-first dose (pre-first dose on following day, fasted).|2 weeks|All patients who received any amount of both study medications (NaPBA and HPN-100) were included in this population, which is the primary population for analysis of efficacy and pharmacokinetic parameters.|||umol/L*hours||Standard Deviation|Mean
2686834|NCT01347073|Primary|Adverse Events|Rate of adverse events during the Switch-Over portion of the Protocol|2 weeks|All patients who received any amount of study medication were included in this population, which is the primary population for all baseline, accountability, demographic and safety analyses.|||participants|||Number
2686835|NCT01347060|Secondary|Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant|The number of albuterol canisters dispensed was used as a surrogate marker of asthma symptoms.|Up to 7 years from July 1, 2001 to June 30, 2008|Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.|||albuterol canisters||Standard Deviation|Mean
2686836|NCT01347060|Secondary|Mean Asthma-related Costs in the Post-index Period|Asthma-related costs were calculated as pharmacy costs, medical costs, and total asthma (pharmacy plus medical) costs. Medical costs were made up of asthma-related visits, hospitalizations, emergency department visits, and medical office visits. Pharmacy costs were comprised of all asthma-related medications used during the follow-up period. Medical services were identified by place of service and PharMetrics-specific confinement codes. Prescriptions were counted by 30-day fills, with fills less than 30 days rounded up to indicate one fill.|Up to 7 years from July 1, 2001 to June 30, 2008|Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.|||United States dollars||Standard Deviation|Mean
2686837|NCT01347060|Primary|Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims|Asthma-related events were defined as events with any primary ICD-9 code of 493.xx for hospitalizations, emergency department visits, and combined hospitalization/emergency department visits. The post-index period is defined as 3-12 months after either the first administration of fluticasone propionate and salmetrol or inhaled corticosteroids. Medical and pharmacy claims are recorded healthcare encounters in a large managed care administrative insurance database.|Up to 7 years from July 1, 2001 to June 30, 2008|Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.|||Asthma-related events||Standard Deviation|Mean
2686918|NCT01346475|Primary|Frequency of HSV-2 Total Shedding From the Genital Tract as Measured by PCR, Calculated Using a Per-day Shedding Rate in Participants Treated With High-dose Valacyclovir as Compared to Once-daily Valacyclovir.||11 weeks|Participants who collected at least one swab on each arm of the cross-over were included in the analysis.|||percentage of swabs with HSV detected|Swabs||Number
2686838|NCT01347034|Secondary|Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) and Adverse Events (AEs)|Evaluate the safety of intratumoral injections of DCs in combination with an intensified RT regimen patients with high-grade large STS. Toxicity assessments were performed weekly to include assessments for: constitutional symptoms, fever, fatigue; common radiation side effects; special attention was paid to DC injection and biopsy related toxicity. Only treatment related SAEs and AEs are reported for this measure.|11 weeks per participant|All participants|||participants|||Number
2686839|NCT01347034|Primary|Number of Participants With Enhanced T Lymphocyte Immune Response Specific for Soft Tissue Sarcoma Tumor Associated Antigens(STS-TAAs)|Investigate the ability of an intensified radiation therapy (RT) regimen (namely, conventional RT with a high-dose hypofractionated boost) and Dendritic Cell (DC) administration to induce an enhanced T lymphocyte immune response specific for STS-TAAs. Criteria for immune response evaluation: Individual patients were considered as responders to TAAs if at any time point the response in IFN-γ ELISPOT assay was found higher than 30 spots per 200,000 cells or in proliferation assay higher than 3000 counts/min (CPM) AND the response in IFN-γ ELISPOT or proliferation assays to tumor cell lysates (TCL) or Ad-Surv was found more than 2SD higher than the response to corresponding control lysate or Ad-c at the same time point AND 2SD higher than the response to the same stimuli at a base line (before start of the treatment).|11 weeks per participant|All participants|||participants|||Number
2686840|NCT01347008|Secondary|Daily Frequency of Raynaud's Phenomenon Attacks|Daily frequency of RP attacks as self registered in a 1-week diary. Any episode of pallor or cyanosis of the hand/fingers was considered as a RP attack, and patients were supposed to register the daily amount of such episodes on a 1-week diary, previously to the medical visit.|8 weeks||||number of attacks per day||Standard Deviation|Mean
2686841|NCT01347008|Primary|Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) After Cold Stimulus.||8 weeks||||perfusion units||Standard Deviation|Mean
2686842|NCT01347008|Primary|Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) Before Cold Stimulus|Finger blood flow of the four medial fingers, measured by laser Doppler imaging and expressed in arbitrary perfusion units (p.u.).|8 weeks||||perfusion units||Standard Deviation|Mean
2686843|NCT01346852|Secondary|Mean Number of Short-acting Beta-agonist (SABA) Canisters Used|The number of albuterol canisters dispensed is a marker that is well established in predicting future asthma events in an adult population.|January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods|Ingenix Impact National Managed Care Database members who had >=1 ICD-9 code for asthma and had >= 1 controller medication or >=1 albuterol canister dispensed during the 12-month pre-index period.|||canisters||Standard Deviation|Mean
2686844|NCT01346852|Primary|Mean Ratio of Controller Medication to Total Asthma Medication|The ratio of controller medication (CM) to total asthma medication (AM), which is well established in predicting future asthma events in adults, was calculated as the ratio of the units of CMs used during the defined period divided by the sum of the units of CMs plus the units of inhaled short-acting beta-agonists used during the same period. A CM is defined as any inhaled corticosteroid containing medication, methylxanthines, leukotriene receptor antagonists, or cromolyn sodium. The ratio is calculated using all CM. Asthma controllers are medications used to treat asthma on a regular basis.|January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods|Ingenix Impact National Managed Care Database members who had >=1 ICD-9 code for asthma and had >= 1 controller medication or >=5 albuterol canisters dispensed identified in the database during the 12-month identification period (pre-index). We tested 3 different capture/follow-up periods; thus, sample sizes varied depending capture period used.|||ratio||Standard Deviation|Mean
2686845|NCT01346839|Secondary|Trigger Positive Predictive Value|Positive Predictive Values of each of the triggers in identifying patients with a true delay in diagnostic evaluation. Calculated as: percentage of patients identified as trigger positive that actually had a delay.|15 months||||Percentage of participants|||Number
2686846|NCT01346839|Secondary|Number of Participants Diagnosed With Cancer After Delay in Diagnostic Evaluation|Subsequent diagnosis of nonmalignant neoplasia, cancer, or death, and treatments required as a result of new cancer diagnoses after a pre-specified interval.|15 months||||Number of patients diagnosed with cancer|||Number
2686847|NCT01346839|Secondary|Percentage of Cases With no Documented Justification for no Follow-up|This is a descriptive sub-analysis looking only at cases with no follow-up at the end of the follow-up period. Specifically, out of the cases that never got follow-up, this represents the percent of that subsample that had no justification in the medical record for the lack of follow-up. This is based on manual chart reviews.|15 months||||percentage with no documentation|||Number
2686848|NCT01346839|Secondary|Percentage of Patients Receiving Timely Follow-up of a Red Flag Suggestive of Cancer|The percentage of patients receiving timely follow-up care, as defined by action taken by provider within appropriate pre-defined time intervals for each diagnostic clue, in both intervention and control groups.|15 months||||percentage of follow-up|||Number
2686849|NCT01346839|Primary|Differences in Time to Documented Follow-up of a Red Flag Suggestive of Cancer|Differences between the intervention and control groups (based on a Cox Proportional Hazards Survival Analysis) in median time to documented follow-up of a red flag (e.g., colonoscopy performance after positive FOBT) or of a deliberate decision by the treating provider not to take follow-up action. When less than 50% of patients in either group received diagnostic evaluation (ie, medians were not reached), the point at which 40% received diagnostic evaluation was compared instead.|15 months||||Days||Inter-Quartile Range|Median
2686850|NCT01346774|Primary|Participants With Clinically-diagnosed and Treated UTI's.|The primary endpoint was the number of participants who were clinically-diagnosed and treated for UTI whether or not results from a urine culture were available. All UTI's were confirmed via medical records.|From surgery to post-op visit, approximately 6 weeks post surgery|Analysis was run on all 160 subjects that were ascribed to an arm of the study. Data were analyzed using an intent to treat protocol.|||participants||95% Confidence Interval|Number
2686851|NCT01346696|Secondary|Crown-to-implant Ratio|Crown height measured radiographically from the implant-abutment interface to the most coronal point on the prosthesis. The crown-to-implant ratio calculated from radiographs|12 months after implant loading|"45 subjects (90 implants) completed the 12-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants).~6 of the collected radiographs were not possible to evaluate, giving an overall number of 35 subjects (68 implants) as basis for 12 months analysis of Crown-to-implant ratio."|||Ratio|Implants|Standard Deviation|Mean
2686852|NCT01346696|Secondary|Plaque|Occurence of plaque around the study implant. Presented as proportion of implants that showed presence of plaque at the 36 months follow-up visit.|Evaluated 36 months after implant loading.|"44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants).~Plaque measurement was not completed for one implant, giving an overall number of 36 subjects (74 implants) as basis for the 36 months analysis of Plaque."|||Implants|Implants||Count of Units
2686853|NCT01346696|Secondary|Condition of the Periimplant Mucosa (BoP).|"Condition of the periimplant mucosa will be measured by assessment of bleeding on probing (BoP).~Presented as % of the implants that show presence of bleeding at time of the 36 months follow-up."|Evaluated from implant loading to 36 months after implant loading.|"44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants).~The BoP measurement was not completed for one implant, giving an overall number of 36 subjects (74 implants) as basis for the 36 months analysis of BoP."|||Implants|Implants||Count of Units
2686854|NCT01346696|Secondary|Condition of the Periimplant Mucosa (PPD).|"Condition of the periimplant mucosa measured by assessment of probing pocket depth (PPD).~Change in pocket depth expressed in millimeters at the 36 month follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).~Negative value = increased pocket depth"|Evaluated from implant loading to 36 months after implant loading.|"44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants).~Baseline and/or follow-up measurements not available for 3 implants, giving an overall number of 36 subjects (72 implants) as basis for the 36 months analysis of PPD change."|||millimeter|Implants|Standard Deviation|Mean
2686855|NCT01346696|Secondary|Implant Stability|Implant stability evaluated clinically/manually (recorded as stable yes/no).|Evaluated 36 months after implant loading.|44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants).|||Implants|Implants||Count of Units
2686856|NCT01346696|Secondary|Implant Survival|Implant survival rate evaluated clinically and radiographically.|Evaluated from implant installation to 36 months after implant loading.|44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants).|||Implants|Implants||Count of Units
2686857|NCT01346696|Secondary|Marginal Bone Level Alteration After 36 Months|"Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 36 months after loading.~Positive value = bone gain, Negative values = bone loss."|Evaluated from implant loading to 36 months after implant loading.|"44 subjects (90 implants) completed the 36-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants).~Four of the collected radiographs were not possible to evaluate, giving an overall number of 35 subjects (71 implants) as basis for the 36 months analysis."|||millimeter||Standard Deviation|Mean
2686858|NCT01346696|Primary|Marginal Bone Level Alteration|"Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant, and expressed in millimeters. Marginal Bone Level change calculated from values obtained at delivery of permanent restoration i.e. loading of implants (baseline) compared to the values obtained at the follow-up visit 12 months after loading.~Positive value = bone gain, Negative values = bone loss."|Evaluated from implant installation to 12 months after implant loading|"45 subjects (90 implants) completed the 12-month follow-up visit. Protocol deviations were excluded, giving a per-protocol analysis population of 36 subjects (75 implants).~Six of the collected radiographs were not possible to evaluate, giving an overall number of 35 subjects (69 implants) as basis for the 12 months analysis of MBL change."|||millimeter|Implants|Standard Deviation|Mean
2686859|NCT01346683|Secondary|Soft Tissue Status (BoP)|Soft tissue status measured by assessment of bleeding on probing (BoP).|Measured from loading of implants to the follow-up 36 months after loading.|Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants).|||Implants|Implants||Count of Units
2686860|NCT01346683|Secondary|Soft Tissue Status (PPD).|"Soft tissue status measured by assessment of probing pocket depth (PPD). PPD was measured at 4 different surfaces (mesial, distal, buccal and lingual) and change compared to baseline (loading) was analyzed.~A negative value = increased pocket depth."|Measured from loading of implants to the follow-up 36 months after loading.|Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants).|||millimeter|Implants|Standard Deviation|Mean
2686861|NCT01346683|Secondary|Implant Stability|Implant stability evaluated clinically/manually (recorded as stable yes/no)|Measured from loading of implants to the follow-up 36 months after loading.|Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants).|||Implants|Implants||Count of Units
2686862|NCT01346683|Secondary|Implant Survival|Implant survival rate evaluated clinically and radiographically.|From implant placement to the follow-up 36 months after loading.|Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants).|||Implants|Implants||Count of Units
2686863|NCT01346683|Primary|Marginal Bone Level Alteration|Marginal Bone Level determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 3 year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).|Evaluated 3 years after implant loading|"Protocol deviations excluded, a total of 5 subjects (15 implants), resulting in a per protocol analysis population of 40 subjects (92 implants).~In addition a total of 2 subjects (4 implants) had radiographs were not possible measure. Giving an analysis population of 38 subjects (88 implants) for the primary outcome measure."|||millimeter|Implants|Standard Deviation|Mean
2686864|NCT01346592|Secondary|Number of Subjects Reporting Unsolicited Adverse Events After Vaccination|The number of subjects reporting any unsolicited adverse events (AEs) between Day 1 to Day 50, serious adverse events (SAEs), AE leading to withdrawal (WD), new onset of chronic disease(NOCD), adverse events of special interest following vaccination with aTIV or licensed comparator or TIV throughout the study (Day 1 to Day 394).|Day 1 to Day 394|Analysis was done on the safety population i.e all subjects who had received at least one study vaccine and had postvaccination safety data|||Participants|||Number
2686865|NCT01346592|Secondary|Number of Subjects Reporting Solicited Adverse Events After Vaccination|The number of subjects reporting any solicited local and systemic adverse events (AEs), following vaccination with aTIV or licensed comparator or TIV.|Day 1 through Day 7 after any vaccination|Analysis was done on solicited safety set i.e all subjects who had received at least one study vaccine and had provided data on post vaccination solicited AEs|||Participants|||Number
2686866|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination|To demonstrate the GMTs at three weeks after one dose of aTIV are statistically significantly higher to the corresponding response's of comparator TIV and TIV.|Day 1, Day 29|Analysis was done on the FAS (Persistence).|||Titers||95% Confidence Interval|Geometric Mean
2686867|NCT01346592|Secondary|Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains|The percentage of subjects achieving seroconversion or ≥4 fold increase in HI titers from baseline, against heterologous strains, at three weeks and six months after last vaccination with aTIV or licensed comparator or TIV.|Day 50, Day 209|Subjects aged 6 through <72 months of age - Full Analyses Set (FAS) Persistence|||Percentage of subjects||95% Confidence Interval|Number
2686868|NCT01346592|Secondary|The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group)|The HI antibody titers against the heterologous strains following vaccination with either aTIV, licensed comparator or TIV, at three weeks and at six months after vaccination are reported as GMTs.|Day 1, Day 50, Day 209|Analysis was done on the FAS Persistence|||Titers||95% Confidence Interval|Geometric Mean
2686869|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, at Risk/Not at Risk, by Age Sub Group-FAS|The superiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains, in subjects with a defined set of underlying medical conditions (at risk) and in healthy subjects (not at risk), by age sub group.|Day 50|Analysis was done on Full Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2686870|NCT01346592|Secondary|Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Sub Group-FAS|The superiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of of percentage of subjects achieving seroconversion or ≥4-fold increase in HI Titer at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.|Day 50|Analysis was done on the Full Analysis Set.|||Percentages of subjects||95% Confidence Interval|Number
2686871|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV Versus Comparator TIV and TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Subgroup|The non-inferiority of HI antibody responses of aTIV to that of the licensed comparator TIV and to investigational TIV was assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains in subjects with a defined set of underlying medical conditions (at risk) and in healthy subjects (not at risk) , by age sub group.|Day 50|Analysis was done on the Per Protocol Set.|||Percentages of subjects||95% Confidence Interval|Number
2686872|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, Subjects at Risk/Not at Risk, by Age Subgroup|The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains, in subjects with a defined set of underlying medical conditions (at risk) and healthy subjects (not at risk), by age sub group.|Day 50|Analysis was done on the PPS.|||Titers||95% Confidence Interval|Geometric Mean
2686873|NCT01346592|Secondary|Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains|The percentage of subjects achieving seroconversion ≥4 fold increase in HI titers from baseline, against homologous strains, at three weeks and six months after vaccination with ATIV or licensed comparator or TIV.|Day 29, Day 50, Day 209|Analysis was done on FAS (Persistence)|||Percentage of subjects||95% Confidence Interval|Number
2686874|NCT01346592|Secondary|Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group|The percentage of subjects demonstrating HI titers ≥40,against homologous strains, at three weeks and six months after vaccination with aTIV or licensed comparator or TIV.|Day 1, Day 29, Day 50, Day 209|Analysis was done on FAS (Persistence)|||Percentage of subjects||95% Confidence Interval|Number
2686875|NCT01346592|Secondary|Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains|The GMR of post-vaccination versus pre-vaccination HI titers against homologous strains, three weeks (day 29/day 1; day 50/day 1)and six months (day 209/day 1) after vaccination with either aTIV, licensed comparator or TIV.|Day 29, Day 50, Day 209|Analysis was done on FAS (Persistence)|||Ratios||95% Confidence Interval|Geometric Mean
2686876|NCT01346592|Secondary|The HI GMTs Against Homologous Strains, by Vaccine Group|The HI antibody titers against the three homologous strains following vaccination with either aTIV, licensed comparator or TIV, at three weeks and at six months after vaccination are reported as GMTs.|Day 1, Day 29, Day 50, Day 209|Analysis was done on FAS (Persistence) i.e. all subjects in the enrolled population who actually received a study vaccination, and provided evaluable serum samples at all relevant timepoints and also at day 209.|||Titers||95% Confidence Interval|Geometric Mean
2686919|NCT01346410|Secondary|Late Toxicity Rate|Toxicities will be graded using CTCAE criteria at specified timepoints.|5 years|This outcome was not collected as planned.||||||
2686877|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers Against Homologous Strains (6 to <72 Months)-FAS|The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion ≥4 fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.|Day 50|Analysis was done on the FAS|||Percentage of subjects||95% Confidence Interval|Number
2686878|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS|The superiority of HI antibody responses, in subjects 6 to <72 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.|Day 1, Day 50|Analysis was done on the FAS|||Titers||95% Confidence Interval|Geometric Mean
2686879|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains (6 to <24 Months)|The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of number of subjects achieving seroconversion at three weeks after last vaccination against the three homologous vaccine strains.|Day 50|Analysis was done on the FAS|||Percentage of subjects||95% Confidence Interval|Number
2686880|NCT01346592|Secondary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months)|The superiority of HI antibody responses, in subjects 6 to <24 months of age, of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.|Day 1, Day 50|Analysis was done on the Full Analysis Set (FAS) i.e all enrolled subjects who received study vaccination and provided serum samples.|||Titers||95% Confidence Interval|Geometric Mean
2686881|NCT01346592|Primary|Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects 6 to <36 Months of Age|The non-inferiority of HI antibody responses of TIV to that of the licensed comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.|Day 50|Subjects aged 6 through <36 months of age - Per Protocol Set (PPS).|||Percentage of subjects||95% Confidence Interval|Number
2686882|NCT01346592|Primary|Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months)|The non-inferiority of HI antibody responses of TIV to that of comparator TIV, in subjects aged 6 to <36 Months, assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.|Day 1, Day 50|Analysis was done on the PPS.|||Titers||95% Confidence Interval|Geometric Mean
2686883|NCT01346592|Primary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titers Against Homologous Strains|"The non-inferiority of HI antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of percentage of subjects achieving seroconversion or ≥4-fold increase in HI titers at three weeks after last vaccination against the three homologous vaccine strains.~Seroconversion defined as prevaccination HI titer <10 and postvaccination HI titer ≥40 or at least a 4-fold increase in HI titers from prevaccination HI titer ≥10."|Day 50|Analysis was done on the PPS.|||Percentage of subjects||95% Confidence Interval|Number
2686884|NCT01346592|Primary|Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains|The non-inferiority of Hemagglutination Inhibition (HI) antibody responses of aTIV compared to TIV and comparator TIV assessed in terms of post vaccination GMTs at three weeks after last vaccination against the three homologous vaccine strains.|Day 1, Day 50|Analysis was done on the Per Protocol Set (PPS) i.e all subjects in the enrolled population who correctly received the study vaccine, provided evaluable serum samples at relevant time-points and had no major protocol violations as defined prior to unblinding.|||Titers||95% Confidence Interval|Geometric Mean
2686885|NCT01346540|Primary|Maximum Tolerated Dose (MTD) of Nintedanib Added to Cisplatin/Gemcitabine Based on the Occurrence of DLTs During Treatment Cycle 1.|The MTD was defined as the dose of nintedanib administered with gemcitabine/cisplatin at which no more than 1 of 6 patients experienced DLT (or one dose tier below that dose at which 2 or more of 6 patients experienced DLT) during the first 21-day treatment cycle. Any DLTs experienced after the start of the second treatment period were considered separately.|Up to 21 days from first drug administration|All patients who received at least one dose of nintedanib were included in the Safety Set.|||Milligram|||Number
2686886|NCT01346540|Secondary|Incidence of Adverse Events (AEs) According to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.00|Incidence of adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.00 with grade 1-5.|From the first drug administration until 28 days after last study drug administration, up to 804 days|Treated Set|||Participants|||Number
2686887|NCT01346540|Primary|Number of Participants With Dose Limiting Toxicities (DLTs) During First Cycle for the Determination of the Maximum Tolerated Dose (MTD)|The following drug-related adverse events (AEs) qualified as a DLT: Non-hematological toxicity - Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥3 events excluding transient electrolyte abnormality, hyperuricemia and isolated elevation of gamma-glutamyl trans-peptidase. Gastrointestinal AEs (nausea, vomiting, diarrhoea, abdominal pain) or hypertension of CTCAE Grade ≥3 despite optimal supportive care/intervention. Alanine aminotransferase and or Aspartate aminotransferase elevation of CTCAE Grade ≥3. Haematological toxicity - Uncomplicated CTCAE Grade 4 neutropenia (that was not associated with fever of ≥38.5° Celsius) for >7 days (except during Cycle 1). CTCAE Grade 4 febrile neutropenia associated with fever ≥38.5º Celsius. A decrease in platelet levels to CTCAE Grade 4 or CTCAE Grade 3 associated with bleeding or requiring transfusion. The inability to resume nintedanib dosing within 14 days of stopping due to a drug-related AE was also considered a DLT.|Up to 21 days from first drug administration|All patients who received at least one dose of nintedanib were included in the Safety Set.|||Participants|||Number
2695945|NCT01274559|Secondary|Percent Change From Baseline in Triglyceride (TG) at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2686889|NCT01346514|Secondary|Change in Mental Health Status in AHCM vs. HSG From Baseline to 12 Months|Determine if Addiction/Housing Case Management compared to a Housing Support Group control significantly improved mental health outcomes, as measured by the Psychiatric Composite Score (range 0 to 1, with higher scores indicating greater severity) on the Addiction Severity Index (ASI) and the Mental Component Summary (MCS, range 0 to 100 with lower scores indicating greater severity) of the SF-36, among homeless Veterans entering addiction specialty care over the 12-month study course. Negative change on the ASI Psychiatric Composite Score indicates improvement. Positive change on the SF-36 MCS indicates improvement.|Baseline to 12 months||||units on a scale||95% Confidence Interval|Mean
2686890|NCT01346514|Secondary|Change in Percent of Participants Abstinent From Baseline to 12 Month Follow-up|Determine if Addiction/Housing Case Management compared to a Housing Support Group control significantly increase the percent of participants abstinent from alcohol and drugs over the past 30 days among homeless Veterans entering addiction specialty care over the 12-month study course. Positive change indicates improvement.|Baseline to 12 months||||precentage of participants||95% Confidence Interval|Number
2686891|NCT01346514|Secondary|Change in Alcohol and Drug Outcomes in AHCM vs. HSG From Baseline to 12 Months|Determine if Addiction/Housing Case Management compared to a Housing Support Group control significantly improved alcohol and drug outcomes, as measured by Alcohol and Drug Composite Scores (range 0 to 1, with higher scores indicating greater severity) on the Addiction Severity Index (ASI), among homeless Veterans entering addiction specialty care over the 12-month study course. Negative change on the ASI measures indicates improvement.|Baseline to 12 months||||units on a scale||95% Confidence Interval|Mean
2686892|NCT01346514|Secondary|Change in Functional Status in AHCM vs. HSG From Baseline to 12 Months|Determine if Addiction/Housing Case Management compared to a Housing Support Group control significantly improved functional status outcomes among homeless Veterans entering addiction specialty care over the 12-month study course. Functional status was measured by Medical, Employment, Family/Social, and Legal Composite Scores (range 0 to 1 with higher scores indicating greater severity) on the Addiction Severity Index (ASI) and the Physical Component Summary (PCS, range 0 to 100 with lower scores indicating greater severity) on the SF-36. Negative change on the ASI measures indicates improvement. Positive change on the SF-36 PCS indicates improvement.|Baseline to 12 months||||units on a scale||95% Confidence Interval|Mean
2686893|NCT01346514|Secondary|Costs and Cost-effectiveness of AHCM vs. HSG, Baseline to 12 Months|Costs and cost-effectiveness of Addiction/Housing Case Management to the Housing Support Group condition.|Baseline to 12 months|These analyses were not completed due to the lack of differences seen in the primary study outcomes (percent days housed) and quality of life measures (SF-36).||||||
2686894|NCT01346514|Primary|Percent Days Housed in AHCM vs. HSG, Baseline to 12 Months.|The primary aim is to determine whether the Addiction/Housing Case Management intervention increases percent days in long-term housing (permanent or long-term transitional) during the year following treatment entry relative to a Housing Support Group.|12 months (18 to 24 month outcomes examined in secondary analyses)|The percent of days in long-term transitional housing and/or own home was calculated for all patients using self-report and VA Homeless Operations Management and Evaluation System (HOMES) data. Individuals with no self-report or HOMES data were coded as not housed.|||percent days housed||95% Confidence Interval|Mean
2686895|NCT01346501|Secondary|Percentage of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions|Adverse drug reactions (serious and non-serious) are adverse events for which the causal relationship between adalimumab and the event could not be ruled out. Adverse event was defined as any untoward or unintended medical occurrences (including abnormal laboratory findings), signs/symptoms, or diseases of the participant receiving adalimumab, regardless of causality of adalimumab treatment. Data are presented as percentage of participants.|From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years|Safety was assessed in participants who received adalimumab in the observation period of studies P12-069 and P12-707, in routine clinical practice. Refer 'reporting group description' for the definition of safety analysis set.|||Percentage of participants|||Number
2686896|NCT01346501|Secondary|Percentage of Participants With Modified Total Sharp Score (mTSS) ≤ 0.5 and ≤ 1.5|The mTSS, a method of assessing radiographs, was used to evaluate the level of joint destruction by disease. Digitized X-rays of hands and feet were obtained and scored on a scale ranging from 0 [no damage] to 5 [complete collapse or total destruction of joint] for erosion and 0 [no damage] to 4 [complete luxation of joint] for joint space narrowing. The scores on each task were summed and averaged to derive the total mTSS score ranging from 0 [normal] to 380 [maximal disease]. Large positive change in mTSS indicated disease progression; small positive/no change indicated slowing/halting of disease progression. The mTSS score ≤ 0.5 was defined as minimal radiographic progression. Data are presented as the percentage of the participants with mTSS ≤ 0.5 and ≤ 1.5 at the end of third year of the observation period (at Week 104 of P12-707).|3 years|The effectiveness analysis set was defined as all participants who had evaluable mTSS score during studies P12-069 and P12-707.|||Percentage of participants|||Number
2686897|NCT01346501|Primary|Mean Health Assessment Questionnaire (HAQ) Score|The HAQ score was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past seven days using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0-1 represented mild disability and 2-3 represented severe disability. Data are presented as mean HAQ score +/- standard deviation with negative scores indicating improvement.|At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208|The effectiveness analysis set was defined as all participants who had evaluable HAQ score during studies P12-069 and P12-707.|||Score on a scale||Standard Deviation|Mean
2686920|NCT01346410|Primary|Local Control Rate|Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques such as CT or MRI. Local recurrence will be defined as an increase of > 20% in tumor size. If necessary, a Positron Emission Tomography scan may be used to aid in diagnoses of local tumor recurrence.|5 years||||Participants|||Count of Participants
2686898|NCT01346501|Primary|Percentage of Participants With Positive Serum Level of Matrix Metalloprotease-3 (MMP-3)|MMP-3, a proteolytic enzyme that plays a pivotal role in joint destruction in RA was assessed during the study. MMP-3 serum level < 121 ng/mL in men and < 59.7 ng/mL in women was considered as the normal value. Data are presented as the percentage of participants with MMP-3 serum level greater than the normal value.|At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208|The effectiveness analysis set was defined as all participants who had evaluable MMP-3 score during studies P12-069 and P12-707.|||Percentage of participants|||Number
2686899|NCT01346501|Primary|Percentage of Participants With Disease Activity Score 28 - C-Reactive Protein (DAS28-CRP) Score < 3.2 After Discontinuation of Adalimumab Treatment|The DAS28-CRP, a combined index that measured Rheumatoid Arthritis (RA) disease activity, was calculated based on the number of tender joint count (28 joints), the number of swollen joint count (28 joints), overall disease activity (using visual analog scale (VAS)), erythrocyte sedimentation rate (ESR), and C-Reactive protein (CRP). The DAS28-CRP scores ranged from 0 (no disease activity) to 9 (maximal disease activity); decrease in DAS28-CRP score indicated improvement of disease. In participants who discontinued treatment with adalimumab after sustained low disease activity (defined as DAS28-CRP score <3.2) in study M06-859, the percentage of participants who maintained DAS28-CRP score < 3.2 without disease flare (defined as DAS28-CRP score ≥ 3.2) during studies P12-069 and P12-707 was calculated.|At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, and Week 156|The effectiveness analysis set was defined as all participants who had evaluable DAS28-CRP score during studies P12-069 and P12-707.|||Percentage of participants|||Number
2686900|NCT01346488|Secondary|Number of Participants With Adverse Drug Reactions|Adverse drug reactions were defined as AEs of which a causal relationship with adalimumab could not be ruled out.|up to Week 52|Safety Analysis Set (all evaluable participants with validated CRFs)|||Participants|||Count of Participants
2686901|NCT01346488|Secondary|Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Deaths|AEs, which were defined as any untoward medical occurrence observed in participants who received adalimumab in this study, were summarized.|up to Week 52|Safety Analysis Set (all evaluable participants with validated CRFs)|||Participants|||Count of Participants
2686902|NCT01346488|Secondary|Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score|"The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.594 to 1 (with higher scores indicating better health state). Change was calculated as the value at baseline minus the value at each subsequent time point."|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable EQ-5D assessments; number analyzed=participants with an evaluable assessment at given time point.|||units on a scale||Standard Deviation|Mean
2686903|NCT01346488|Secondary|Number of Participants Per Category of the CDAI|The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a VAS from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). Categories were defined as: high (> 22.1), moderate (≤ 22.0 to > 10.0), low (≤ 10.0 to < 2.8), and remission (≤ 2.8).|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable CDAI assessments; number analyzed=participants with an evaluable assessment at given time point.|||Participants|||Count of Participants
2686904|NCT01346488|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI)|"The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a VAS from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). Change was calculated as the value at baseline minus the value at each subsequent time point."|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable CDAI assessments; number analyzed=participants with an evaluable assessment at given time point.|||units on a scale||Standard Deviation|Mean
2686905|NCT01346488|Secondary|Number of Participants Per Category of the DAS28-4 ESR|DAS28-4 ESR, a combined index that measures activity of RA, was calculated based on the number of tender and swollen joints (out of 28 counted), general health evaluated by a VAS, and ESR. DAS28-4 ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity). Categories were defined as: high (> 5.1), moderate (≤ 5.1 to > 3.2), low (≤ 3.2 to ≥ 2.6), remission (< 2.6).|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable DAS28-4 CRP assessments; number analyzed=participants with an evaluable assessment at given time point.|||Participants|||Count of Participants
2686906|NCT01346488|Secondary|Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR)|DAS28-4 ESR, a combined index that measures activity of RA, was calculated based on the number of tender and swollen joints (out of 28 counted), general health evaluated by a VAS, and ESR. DAS28-4 ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity). A decrease from Baseline in scores indicates improvement of disease activity.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable DAS28-4 ESR assessments; number analyzed=participants with an evaluable assessment at given time point.|||units on a scale||Standard Deviation|Mean
2686907|NCT01346488|Secondary|Number of Participants Per Category of the DAS28-4 CRP|DAS28-4 CRP was calculated using the number of tender and swollen joints (out of 28 counted), CRP level, and the participant's global assessment of disease activity via a VAS. The calculated range of DAS28-4 is 0 (no disease activity) to 10 (maximal disease activity). Categories were defined as: high (> 5.1), moderate (≤ 5.1 to > 3.2), low (≤ 3.2 to ≥ 2.6), remission (< 2.6).|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable DAS28-4 CRP assessments; number analyzed=participants with an evaluable assessment at given time point.|||Participants|||Count of Participants
2686908|NCT01346488|Secondary|Change From Baseline in Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP)|DAS28-4 CRP was calculated using the number of tender and swollen joints (out of 28 counted), CRP level, and the participant's global assessment of disease activity via a visual analog scale (VAS). The calculated range of DAS28-4 is 0 (no disease activity) to 10 (maximal disease activity). A decrease from Baseline in score indicates improvement of disease activity.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable HAQ-DI assessments; number analyzed=participants with an evaluable assessment at given time point.|||units on a scale||Standard Deviation|Mean
2686909|NCT01346488|Primary|Number of Participants Per Category of the HAQ-DI|The HAQ-DI is a patient-reported questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high-dependency disability). Categories were defined as: high (> 1.5), moderate (≤ 1.5 to > 1.0), low (≤ 1.0 to > 0.5), remission (≤ 0.5 to > 0), 0 (0).|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable HAQ-DI assessments; number analyzed=participants with an evaluable assessment at given time point.|||Participants|||Count of Participants
2686910|NCT01346488|Primary|Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score|The HAQ-DI is a patient-reported questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high-dependency disability). A negative change from Baseline in the score indicates improvement.|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable HAQ-DI assessments; number analyzed=participants with an evaluable assessment at given time point.|||units on a scale||Standard Deviation|Mean
2686911|NCT01346488|Primary|Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA|"Activity impairment due to RA (the extent to which RA affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change was calculated as the value at baseline minus the value at each subsequent time point."|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48)|Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.|||percentage of activity impairment||Standard Deviation|Mean
2686912|NCT01346488|Primary|Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to RA|"The mean percentage of OWPI due to RA (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which RA decreased productivity (%)* [number of hours worked / (number of hours of work missed due to RA + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change was calculated as the value at baseline minus the value at each subsequent time point."|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48)|Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.|||percentage of OWPI||Standard Deviation|Mean
2686913|NCT01346488|Primary|Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to RA (Presenteeism)|"Presenteeism (the extent to which RA decreased productivity) is presented as the mean percentage of impairment while working due to RA, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change was calculated as the value at baseline minus the value at each subsequent time point."|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48)|Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.|||percentage of impairment while working||Standard Deviation|Mean
2686914|NCT01346488|Primary|Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism)|"Absenteeism, presented as the mean percentage of work time missed due to RA (as reported on the WPAI-RA), and calculated as: 100*number of hours of work missed due to RA / (number of hours of work missed due to RA + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Change was calculated as the value at baseline minus the value at each subsequent time point."|Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of adalimumab (ADA) therapy, and at final assessment (up to Week 48)|Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point.|||percentage of work time missed||Standard Deviation|Mean
2686915|NCT01346475|Secondary|Duration of Genital HSV Shedding Episodes|Median duration of HSV shedding episodes, in hours, among episodes of known duration|11 weeks||||Hours|Episodes|Inter-Quartile Range|Median
2686916|NCT01346475|Secondary|Number of Genital HSV Shedding Episodes|The number of HSV shedding episodes. A shedding episode is defined as any number of positive swabs preceded and followed by 2 negative swabs.|11 weeks||||Episodes|||Number
2686917|NCT01346475|Secondary|Quantity of HSV Detected, Median|Median quantity of HSV detected, among swabs with any HSV detected|11 weeks||||log 10 copies/ml|swabs|Inter-Quartile Range|Median
2686924|NCT01346293|Other Pre-specified|Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Solicited injection-site: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb, Change in Limb Circumference. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection-site: Pain, Incapacitating, unable to perform usual activities; Erythema, Swelling, ≥50 mm; Change in limb circumference >50 mm increase over pre-vaccination measurement; Extensive limb swelling (ELS) was considered severe. Grade 3 systemic reactions: Fever ≥39.0˚C; Headache, Malaise, and Myalgia Significant, prevents daily activity.|Day 0 up to Day 28 post-final vaccination|Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.|||Participants|||Number
2686925|NCT01346293|Other Pre-specified|Summary of Anti-Polio Geometric Mean Titers in Participants That Received Inactivated Poliovirus (IPV) Vaccine as a 4th and 5th Dose|Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay.|Day 0 (pre-booster vaccination) and Day 28 post-booster vaccination|Anti-Polio geometric mean titers were assessed in the Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2686926|NCT01346293|Other Pre-specified|Number of Participants With Booster Response to the Polio Antigens Following Vaccination With Inactivated Poliovirus (IPV) Vaccine as a 4th or 5th Dose|Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Four-fold rise in booster responses between groups was defined as post/pre-vaccination ≥4.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Booster responses to polio antigens following IPV vaccine as 4th or 5th dose were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2686927|NCT01346293|Other Pre-specified|Number of Participants With Seroprotection Against the Polio Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Anti-Poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Seroprotection for anti-polio types was defined as antibody titers ≥1:8 dilution.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection (antibody titers ≥1:8 dilution) against polio antigens was assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2686928|NCT01346293|Other Pre-specified|Number of Participants With Seroprotection Against the Tetanus and Diphtheria Antigens Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Anti-Tetanus antibodies were measured by ELISA. Anti diphtheria antibodies were measured by a toxin neutralization test. Seroprotection for anti-tetanus and anti-diphtheria was defined as antibody concentrations ≥0.1 IU/ml and ≥1.0 IU/ml.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Seroprotection against tetanus and diphtheria antigens was assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2686929|NCT01346293|Primary|Geometric Mean Concentrations of Polio Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Geometric mean concentrations to anti-polio were measured by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean concentrations of poliovirus antibodies were assessed in the Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2686930|NCT01346293|Primary|Number of Participants With Booster Response to Polio Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Anti-poliovirus types 1, 2, and 3 titers were measured by neutralization assay. Booster responses were defined as participants with a pre-vaccination antibody concentration <1:8 dil, achieving a post-vaccination level ≥1:8 dil, or a pre-vaccination antibody concentration ≥1:8 dil, achieving a 4-fold response.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Anti-polio booster responses were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2686931|NCT01346293|Primary|Geometric Mean Concentrations of the Tetanus and Diphtheria Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Geometric mean concentrations to anti-tetanus and anti-diphtheria were measured by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean concentrations of tetanus and diptheria antibodies were assessed in the Per Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2686932|NCT01346293|Primary|Number of Participants With Booster Response to Tetanus and Diphtheria Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Anti-Tetanus antibodies were measured by enzyme-linked immunosorbent assay (ELISA). Anti-Diphtheria antibodies were measured by a toxin neutralization test. Booster responses were defined as participants with a pre-vaccination antibody concentration <0.1 IU/ml, achieving a post-vaccination level ≥0.4 IU/ml, or a pre-vaccination antibody concentration ≥0.1 IU/ml but <2.0 IU/ml, achieving a 4-fold rise rate post-vaccination, or a pre-vaccination antibody concentration ≥2.0 IU/ml, achieving a 2-fold response.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Anti-Tetanus and anti-diphtheria booster responses were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2686933|NCT01346293|Primary|Geometric Mean Concentrations of the Pertussis Antibodies Before and Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Geometric mean concentrations to pertussis antigens (pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], and fimbriae types 2 and 3 [FIM]) were measured by enzyme-linked immunosorbent assay (ELISA).|Day 0 (pre-vaccination) and Day 28 post-vaccination|Geometric mean concentrations were assessed in the Per-Protocol Analysis Set.|||Titers||95% Confidence Interval|Geometric Mean
2686934|NCT01346293|Primary|Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine|Booster responses to pertussis antigens [pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM)] were measured by enzyme-linked immunosorbent assay (ELISA). Booster responses were defined as participants with either a pre-vaccination antibody concentration less than lower limit of quantitation (<LLOQ), achieving a post-vaccination level ≥4X LLOQ, or pre-vaccination antibody concentrations ≥LLOQ but <4X LLOQ, achieving a 4-fold rise rate of post-vaccination, or a pre-vaccination antibody concentration ≥4X LLOQ, achieving a 2-fold response.|Day 0 (pre-vaccination) and Day 28 post-vaccination|Anti-pertussis booster responses were assessed in the Per-Protocol Analysis Set.|||Participants|||Number
2686935|NCT01346189|Secondary|Change in LDL From Baseline to 15 Months|Change in LDL-C levels (mg/dL) from baseline to 15 months|15 months||||mg/dL||95% Confidence Interval|Mean
2686936|NCT01346189|Primary|Change in LDL From Baseline to 12 Months|Change in LDL-C levels (mg/dL)|12 months|Subjects were lost to follow-up, or withdrawn for other reasons. Thus the number analyzed at the 12 month time point does not equal the number analyzed during baseline.|||mg/dL||95% Confidence Interval|Mean
2686937|NCT01346176|Secondary|Patient Satisfaction With Advance Care Planning.|Patients' satisfaction with their advance care planning was assessed two months after they completed their ADs. One of two authors blinded to patients' group assignments contacted patients by phone and administered a satisfaction survey based on the Canadian Healthcare Evaluation Project (CANHELP) questionnaire. This thirteen-item questionnaire has been validated for assessing satisfaction with end-of-life care planning. Patients were asked to indicate satisfaction with various parts of advance care planning (e.g. decisions about the use of life sustaining technologies including CPR or cardiopulmonary resuscitation, breathing machines, and dialysis) on a scale from 1 to 5, where 1 means not at all satisfied and 5 means completely satisfied. The overall average across the 13 item scale in each group is presented in the results below.|Two months after AD completion|These numbers reflect the number of patients who completed and returned and advance directive as well as completed a satisfaction interview and questionnaire with a research associate.|||units on a scale||Full Range|Mean
2686938|NCT01346176|Primary|Proportion of Subjects Who Select Palliative Care Options|The primary outcome variable will be the proportion of subjects that select palliative care options compared to the those who request aggressive treatment in each study arm. We will analyze the effects of manipulating default options and delays in alerting subjects to the presence of multiple default options on each selection in the ADs in order to see how default options influence decisions on general treatment goals and instructions for specific procedures.|6 months|This number was based on the number of participants who returned completed advance directive forms in each group|||percentage who select palliative care||95% Confidence Interval|Number
2686939|NCT01346085|Secondary|Any Adverse Event Throughout Follow-up|Among study participants there were no reports of death, post-transplantation lymphoproliferative disease, cancer, or opportunistic infections. There was no evidence of cytomegalovirus disease, infection or serological activation (CMV early antigens negative during the whole follow-up), nor of Epstein-Barr clinical and serological reactivation (all patients were antibodies anti EBV positive before transplant, as per the inclusion criteria).|up to 3 years|||||||
2686940|NCT01346085|Secondary|Severe Hypoglycemic Events Since Completion of Transplant||up to 3 years|||||||
2686941|NCT01346085|Secondary|the Reduction in Insulin Requirement Compared to Baseline||up to 3 years|||||||
2686942|NCT01346085|Secondary|Basal and Stimulated Blood C-peptide Levels in Response to Arginine Challenge Throughout Follow-up||up to 3 year|||||||
2686943|NCT01346085|Secondary|Glycated Hemoglobin Levels Throughout Follow-up||up to 3 years|||||||
2686944|NCT01346085|Secondary|Insulin Independence With Adequate Glycemic Control Throughout Follow-up||up to 3 years||||participants|||Number
2686945|NCT01346085|Primary|The Proportion of Insulin Free Patients 3 Years After the Last Islet Infusion|Insulin independence is defined as no need for exogenous insulin, with adequate glycemic control [i.e., glycated hemoglobin <7% (normal range 3.5 - 6.0%), fasting glucose levels not exceeding 140 mg/dL (7.8 mmol/L) more than three times per week and 2-hour postprandial levels not exceeding 180 mg/dL (10 mmol/L) more than four times per week].|3 year||||participants|||Number
2686946|NCT01346072|Primary|Body Weight|Change in body weight from baseline to 24 hours after tolvaptan administration|Change over 24 hours|All patients in the Low Copeptin group were included in the analysis. One patient in the High Copeptin group had reduced renal function at baseline versus screening and transient hypovolemia during hospitalization indicative of volume depletion. This patient was excluded prior to review of blinded copeptin results and study data analysis.|||Kg||Standard Deviation|Mean
2686947|NCT01346072|Primary|Urine Output|Total urine output for 24 hours following tolvaptan administration|24 hours|All patients in the Low Copeptin group were included in the analysis. One patient in the High Copeptin group had reduced renal function at baseline versus screening and transient hypovolemia during hospitalization indicative of volume depletion. This patient was excluded prior to review of blinded copeptin results and study data analysis.|||mL||Standard Deviation|Mean
2686948|NCT01346059|Secondary|Need for Colectomy|Partial or complete colectomy performed within 30 days of enrollment|30 day||||Participants|||Count of Participants
2686949|NCT01346059|Secondary|Mortality|Death within 30 days of enrollment, in or out of hospital|30 day||||Participants|||Count of Participants
2686950|NCT01346059|Primary|Resolution of Diarrhea and White Blood Cell Count Elevation|If the patient has resolution of diarrhea, white blood cell count, and abdominal pain, the protocol will be stopped.|14 days||||Participants|||Count of Participants
2686951|NCT01345929|Secondary|The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the TOC Visit in the Microbiologically Evaluable (ME) Population.||Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)|ME: Treated patients, with baseline pathogen, complied with protocol.|||percentage of subjects|||Number
2686952|NCT01345929|Primary|The Percentage of Subjects Who Have Both a Per-subject Microbiological Outcome of Eradication and a Clinical Outcome of Cure at the Test of Cure (TOC) Visit in the Microbiological Modified ITT (mMITT) Population||Test of Cure Visit (7 Days [± 2 days] after completion of study drug administration)|mMITT: Treated subjects, with baseline pathogen.|||percentage of subjects|||Number
2686953|NCT01345786|Secondary|Volume of Distribution (Calculated for NOMAC Only)||blood samples were collected for NOMAC evaluation up to 144 hours postdose|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||L|Participants|Standard Deviation|Mean
2686954|NCT01345786|Secondary|Clearance (Calculated for NOMAC Only)||blood samples were collected for NOMAC evaluation up to 144 hours postdose|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||L/h|Participants|Standard Deviation|Mean
2687016|NCT01345630|Secondary|Frequency of Adverse Events (AE).|Number of participants with treatment-emergent non serious AEs|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.|||participants|||Number
2686955|NCT01345786|Secondary|t1/2 of E2||0 hours to t1/2 (blood samples were collected for E2 evaluation up to 96 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||hours|Participants|Full Range|Mean
2686956|NCT01345786|Secondary|Terminal Phase Half Life (t1/2) of NOMAC||0 hours to t1/2 (blood samples were collected for NOMAC evaluation up to 144 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||hours|Participants|Full Range|Mean
2686957|NCT01345786|Secondary|Tmax of E2||0 hours to tmax of E2 (blood samples were collected for E2 evaluation up to 96 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||hours|Participants|Full Range|Median
2686958|NCT01345786|Secondary|Tmax of NOMAC||0 hours to tmax of NOMAC (blood samples were collected for NOMAC evaluation up to 144 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||hours|Participants|Full Range|Median
2686959|NCT01345786|Primary|Baseline Corrected Area Under the Concentration-time Curve From Time 0 to 72 Hours (AUC72) for E2|"Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2.~AUC72 is the AUC from time 0 to 72 hours.~Blood samples for PK evaluation of E2 were collected predose (-1, -0.5, and 0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose Day 1; multiple predose samples were needed to correct for endogenous levels."|0 hours to 72 hours|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||pg*h/mL|Participants|Full Range|Mean
2686960|NCT01345786|Primary|Area Under the Concentration-time Curve From Time 0 to the Time of the Last Measurable Sample (AUC Last) and Area Under the Concentration-time Curve From Time 0 to Infinity (AUC Infinity) for NOMAC|"Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2.~AUClast is the AUC from time 0 to the time of the final quantifiable sample.~AUC infinity is the AUC from time 0 to infinity.~Blood samples for PK evaluation of NOMAC were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 144 hours postdose Day 1."|0 hours to time of the last measurable sample (blood samples were collected for NOMAC evaluation up to 144 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||ng*h/mL|Participants|Full Range|Mean
2686961|NCT01345786|Primary|Baseline Corrected Maximum Observed Serum Concentration of E2 (Cmax of E2)|"Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2.~Blood samples for PK evaluation of E2 were collected predose (-1, -0.5, and 0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose Day 1; multiple predose samples were needed to correct for endogenous levels."|0 hours to time of maximum observed serum concentration of E2 (tmax of E2) (blood samples were collected for E2 evaluation up to 96 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||pg/mL|Participants|Full Range|Mean
2686962|NCT01345786|Primary|Maximum Observed Plasma Concentration of NOMAC (Cmax of NOMAC)|"Bioequivalence for NOMAC and E2 were tested on the primary PK parameters: Cmax, AUC(infinity), and AUClast for NOMAC; and baseline adjusted AUC72 and Cmax for E2.~Blood samples for pharmacokinetic (PK) evaluation of NOMAC were collected at predose (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 144 hours postdose Day 1."|0 hours to time of maximum observed plasma concentration of NOMAC (tmax of NOMAC) (blood samples were collected for NOMAC evaluation up to 144 hours postdose)|"The # of plasma profiles analyzed is based on the # of single-dose administration periods actually completed (some participants discontinued without completing all 4 dosing periods).~Part 1 analyses also excluded certain data from participants who were misdosed, and Part 2 analyses excluded participants who did not receive drug."|||ng/mL|Participants|Full Range|Mean
2686963|NCT01345721|Secondary|Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination|The safety of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting any unsolicited AEs (day 1 to day 7); serious AEs and AEs necessitating medical attention/or premature withdrawal (day 1 to day 28) after MenACWY-CRM vaccine.|Day 1-28 after vaccination|The analysis was done on the safety dataset.|||Participants|||Number
2686964|NCT01345721|Secondary|Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination|The safety and tolerability of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting solicited local and systemic AEs after MenACWY-CRM vaccine.|Day 1-7 after vaccination|The analysis was done on the safety dataset i.e all subjects who received the study vaccine and provided some post-vaccination safety data|||Participants|||Number
2689648|NCT01325181|Secondary|Change From Baseline in Choroidal Hyperpermeability on Indocyanine Green Angiography|change from baseline in the status of choroidal perfusion and hyperpermeability on indocyanine green angiography throughout the follow-up period|12 months|||||||
2686965|NCT01345721|Secondary|Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine|Comparison of serum antibody titers following a one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y|1 month post vaccination|The analysis was done on the per-protocol dataset|||Titers||95% Confidence Interval|Geometric Mean
2686966|NCT01345721|Secondary|Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine|Comparison of serum antibody responses following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of Men C vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y|1 month post vaccination|The analysis was done on the per-protocol dataset|||Percentages of subjects||95% Confidence Interval|Number
2686967|NCT01345721|Primary|Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine|The serum antibody titers following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C,W,Y|1 month post vaccination|The analysis was done on the per-protocol dataset.|||Titers||95% Confidence Interval|Geometric Mean
2686968|NCT01345721|Primary|Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination|The serum antibody response following a dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C, W,Y|1 month after vaccination|The analysis was done on the per-protocol dataset.|||Percentages of subjects||95% Confidence Interval|Number
2686969|NCT01345721|Primary|Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination|The serum antibody titers following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, are reported as geometric mean titers (GMTs) against N. meningitidis serogroups A,C, W,Y.|1 month post booster vaccination|The analysis was done on the per-protocol dataset.|||Titers||95% Confidence Interval|Geometric Mean
2686970|NCT01345721|Primary|Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination|The serum antibody response following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y.|1 month post booster|The analysis was done on the per-protocol dataset i.e All enrolled subjects who correctly received the vaccine, provided evaluable serum samples at the relevant time points (Day 28),and had no major protocol violation as defined prior to the end of the study.|||Percentages of subjects||95% Confidence Interval|Number
2686971|NCT01345721|Secondary|Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine|The persisting serum bactericidal antibody titers in children, 13-33 months after receiving either one or two doses of MenACWY-CRM vaccine or one dose of Men C vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y|From 13-33 months post last vaccination in parent study (V59P22)|The analysis was done on the per-protocol persistence dataset.|||Titers||95% Confidence Interval|Geometric Mean
2686972|NCT01345721|Primary|Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine|"The percentage of subjects with persisting serum bactericidal antibody (hSBA)titers ≥1:8 against Neisseria meningitidis serogroups A,C,W,Y, 13-33 months after receiving either one or two doses of MenACWY-CRM conjugate vaccine or one dose of MenC vaccine in parent study, is reported.~The functional bactericidal antibodies response against N. meningitidis serogroups was measured with the serum bactericidal assay using human complement (hSBA)"|From 13-33 months post last vaccination in parent study (V59P22)|The analysis was done on the per-protocol persistence dataset i.e all enrolled subjects who provided evaluable serum samples at day 1 of the study and had no major protocol violation as defined prior to the end of the study.|||Percentages of subjects||95% Confidence Interval|Number
2686973|NCT01345682|Secondary|Time to Deterioration in Global Health Status|The time to deterioration was defined as the time from randomisation to a score decreased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS|||months||95% Confidence Interval|Median
2686974|NCT01345682|Secondary|Time to Deterioration in Swallowing|The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS|||months||95% Confidence Interval|Median
2686975|NCT01345682|Secondary|Time to Deterioration in Pain|The time to deterioration was defined as the time from randomisation to a score increased (i.e. worsened) by at least 10 points from baseline (0-100 point scale). If score is missing, and patient died within 28 days after scheduled time for completion, the patient was considered deteriorated. In this case, time to deterioration is time to death.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS|||months||95% Confidence Interval|Median
2686976|NCT01345682|Secondary|Status Change in Global Health Status Scale|Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
2686977|NCT01345682|Secondary|Status Change in Swallowing Scale|Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
2686978|NCT01345682|Secondary|Status Change in Pain Scale|Distribution of patients with improved, stable or worsened HRQOL: Improvement was defined as a score improved by at least 10 points from baseline (on the 0-100 point scale) at any time during the trial. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the trial. Otherwise, a patient was considered as stable.|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
2686979|NCT01345682|Secondary|Health Related Quality of Life (HRQOL)- Change in Global Health Scores Over Time|"The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35:~Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30.~Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30.~The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome.~Changes in scores over time were assessed using longitudinal models.~The analyses of HRQOL are presented for the 07 May 2014 cut-off date."|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)|||scores on a scale||Standard Error|Mean
2686980|NCT01345682|Secondary|Health Related Quality of Life (HRQOL)- Change in Swallowing Scores Over Time|"The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35:~Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30.~Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30.~The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome.~Changes in scores over time were assessed using longitudinal models.~The analyses of HRQOL are presented for the 07 May 2014 cut-off date."|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)|||scores on a scale||Standard Error|Mean
2686981|NCT01345682|Secondary|Health Related Quality of Life (HRQOL)- Change in Pain Scores Over Time|"The HRQOL analyses focused on pain, swallowing, and global health status measured by the European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires Core 30 [QLQ-C30], and head and neck cancer specific supplementary module EORTC QLQ-H&N35:~Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30.~Pain scale includes items 31-34 from H&N 35; Swallowing scale includes items 35-38 from H&N35 and Global health status/QoL scale includes items 29-30 from C30.~The scores of these scales were averaged from the scores of the component items, transformed and analyzed on 0 - 100 scale. For pain and swallowing scales, higher scores represent worse outcome; for the global health/QoL scale, higher scores represent better outcome.~Changes in scores over time were assessed using longitudinal models.~The analyses of HRQOL are presented for the 07 May 2014 cut-off date."|From randomization until one month after discontinuation of study medication, death or data cut-off (07May2014); Up to 28 months.|RS (Only patients with observed cases (OC) values were analysed)|||scores on a scale||Standard Error|Mean
2686982|NCT01345682|Secondary|Tumour Shrinkage|"Tumour shrinkage, defined as the maximum decrease from baseline in the sum of diameters of the target lesions, as measured by central imaging. The longest diameter of target lesions was recorded, except for lymph nodes, which were measured by their short axis.~Negative values indicate a reduction in the sum of target lesion diameters and positive values an increase.~Percentage of Participants with Tumour shrinkage as per the categories (>=20% increase, >=0 − <20% increase, >0 − <30% decrease, >=30 − <50% decrease, >=50% decrease) are presented."|Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months|RS (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
2686983|NCT01345682|Secondary|Disease Control (DC)|"DC is defined as the best overall response of CR, PR, stable disease (SD) and non-CR/non-PD.~CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions . All lymph nodes must be non-pathological in size (<10mm short axis).~PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.~Other factors which add to the overall response of an imaging timepoint as PR are as below:-~CR in TL, but non-CR/Non-PD in NTL leads to PR~CR in TL, but not evaluated NTL leads to PR~PR in TL, but non-PD NTL or not all evaluated NTL leads to PR;~SD for TL: change in the sum of diameters does not satisfy PR or PD.~SD in TL, non-PD in NTL lead to overall response of SD, provided there is no appearance of new lesions."|Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months|RS|||percentage of participants||95% Confidence Interval|Number
2687076|NCT01345162|Primary|Analgesic Efficacy|"percentage of patients with NRS≥4. (NRS=numeric rating scale; o quantify pain from0=no pain to 10=worst pain possible).~NRS≥4 is cosidered as suboptimal pain control worth to be treated with adjunctive analgesics. We therefore condidered the difference in percentage of patients experiencing not optimal pain control in the two groups to understand, if any, the difference in analgesic efficacy between the two drugs."|4 days postherniotomy||||percentage of patients with NRS≥4|||Number
2686984|NCT01345682|Secondary|Objective Response (OR)|"OR is defined as the best overall response of complete response (CR) and partial response (PR) according to RECIST version 1.1, CR for target lesions (TL): Disappearance of all target lesions. CR for non-target lesions (NTL): Disappearance of all non-target lesions. All lymph nodes must be non-pathological in size (<10mm short axis).~PR for TL: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.~Other factors which add to the overall response of an imaging timepoint as PR are as below:-~CR in TL, but non-CR/Non-Progressive Disease (PD) in NTL leads to PR~CR in TL, but not evaluated NTL leads to PR~PR in TL, but non-PD NTL or not all evaluated NTL leads to PR;~All the above scenarios should also satisfy 'No occurrence of new lesions'."|Tumour imaging was to be performed every 6 weeks during the first 24 weeks of treatment, and hereafter every 8 weeks (data cut-off 07May2014); Up to 28 months|RS|||percentage of participants||95% Confidence Interval|Number
2686985|NCT01345682|Secondary|Overall Survival (OS)|Overall survival (OS) was a key secondary endpoint of this trial. OS was defined as the time from randomisation to death (irrespective of the cause of death). Patients for whom there was no evidence of death at the study completion date (06 December 2016) were to be censored on the date that they were last known to be alive.|From randomization until death or study completion date (06Dec2016); Up to 60 months|RS|||months||95% Confidence Interval|Median
2686986|NCT01345682|Primary|Progression-free Survival (PFS) Based on Central Independent Review|"PFS was defined as the time from the date of randomisation to disease progression or death, whichever occurred first. The primary analysis of PFS considered PFS events as assessed by central independent review, including all data collected until the study completion date (06 December 2016).~The date of disease progression was recorded based on RECIST version 1.1. Unequivocal progression of disease was determined if at least one of the following criteria applied:~At least 20% increase in the Sum of Diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm~Appearance of one or more new lesions~Unequivocal progression of existing non-target lesions"|From randomization until disease progression, death or study completion date (06Dec2016); Up to 60 months|Randomised set (RS)|||months||95% Confidence Interval|Median
2686987|NCT01345669|Secondary|Health Related Quality of Life (HRQOL) Scores Over Time|HRQoL questionnaires focused on 3 scales: Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30. Scoring of the symptom scales/items followed the European Organisation for Research and Treatment of Cancer (EORTC) scoring manual and a linear transformation of the scores to a 0-100 point scale. Higher values are better.|Baseline and 5 years|Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)|||Unit on Scale||Standard Error|Least Squares Mean
2686988|NCT01345669|Secondary|Time to Deterioration in Health Related Quality of Life (HRQOL)|HRQoL questionnaires focused on 3 scales: Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30. Time to deterioration was defined as the time from randomisation to the first 10-point worsening on the 0-100 point scale. Patients with no deterioration (including those with disease recurrence/SPT) were censored at the last available HRQoL assessment date. Patients with no post-baseline assessments were censored on the day of randomisation.|Up to 5 years|Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)|||Months||Inter-Quartile Range|Median
2686989|NCT01345669|Secondary|Patients With Improved Health Related Quality of Life (HRQOL)|HRQoL questionnaires focused on 3 scales: Pain scale from H&N35, Swallowing scale from H&N35 and Global health status/QoL scale from C30. Improvement was defined as a score that improved from baseline by at least 10 points (on the 0-100 point scale) at any time during the study. If a patient had not improved, worsening was defined as a 10-point worsening at any time during the study. Patients who had neither improved nor worsened were considered as stable. Percentages of patients with improvement in HRQoL are presented.|Up to 5 years|Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)|||Percentage of Patients|||Number
2686990|NCT01345669|Secondary|Percentage of Patient Deaths (Overall Survival (OS))|Overall survival (OS), defined as the time from randomisation until death (regardless of cause). Due to the small event rate in both treatment arms caused by the early termination of the trial, the hazard estimate is not interpretable. Hence presented the total randomized and the percentage of patients died.|Up to 5 years|Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)|||Percentage of patients|||Number
2686991|NCT01345669|Secondary|Disease Free Survival (DFS) Rate at 2 Years|Disease Free Survival (DFS) rate at 2 years. Probability of being disease free at 2 years in percentage is provided based on Kaplan-Meier method.|Up to 2 years|Randomised Set, the number of patients from the randomized set those are disease free (or DFS) at 2 years.|||Probability (%)||95% Confidence Interval|Number
2686992|NCT01345669|Primary|Disease Free Survival (DFS)|Disease Free Survival defined as the time from randomisation until documented tumour recurrence/ second primary tumour (SPT) or death from any cause, whichever occurred first.|Up to 5 years|Randomised Set (RS): Included all patients who were randomised, regardless of taking investigational treatment (as randomised)|||Months||Inter-Quartile Range|Median
2686993|NCT01345630|Secondary|Change in Bone Turnover Markers From Baseline and at Week 48 - Type 1 Collagen Peptide (CTX-1)|Bone turnover marker, C-telopeptide of type 1 collagen (CTx), was collected in the subset of participants participating in the DEXA scan sub-study.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.|||pg/mL||Standard Deviation|Mean
2686994|NCT01345630|Secondary|Change in Bone Turnover Markers From Baseline and at Week 48 - Blood Osteocalcin|Bone turnover marker, osteocalcin, was collected in the subset of participants participating in the DEXA scan sub-study.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.|||ng/mL||Standard Deviation|Mean
2687170|NCT01344356|Primary|Local Control Rate|Complete or partial tumor response or stable disease|5 years|12 patients did not have local control rate data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up. 3 patients died before data was collected.|||Participants|||Count of Participants
2686995|NCT01345630|Secondary|Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - AP Lumbar Spine (L1 - L4) BMD|Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4) as measured by the DEXA scan.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.|||g/cm^2||Standard Error|Least Squares Mean
2686996|NCT01345630|Secondary|Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Femoral Neck BMD|Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from Baseline bone mineral density femoral neck as measured by the DEXA scan.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.|||g/cm^2||Standard Error|Least Squares Mean
2686997|NCT01345630|Secondary|Changes in Bone Mineral Density (Using DEXA Scan and Serum Markers) From Baseline and at Week 48 - Total Hip BMD|Bone mineral density was evaluated by DEXA scan in a subset of participants who consented to these evaluations. The effects on BMD were addressed by providing LSMs of change from baseline bone mineral density of the lumbar spine (L1-L4), left total hip and femoral neck as measured by the DEXA scan.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.|||g/cm^2||Standard Error|Least Squares Mean
2686998|NCT01345630|Secondary|Changes in Trunk to Limb Fat Distribution Using DEXA Scan From Baseline and at Week 48|A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.|||ratio||Standard Error|Least Squares Mean
2686999|NCT01345630|Secondary|Changes in Peripheral Fat Distribution Using Dual Energy X-ray Absorptiometry [DEXA] Scan From Baseline and at Week 48.|A sub-study was conducted in which the participants underwent whole-body DEXA scans to evaluate peripheral fat tissue estimates for left and right arms and legs and truncal fat mass and truncal lean mass. Truncal abdominal fat were estimated from the DEXA scan field set on the torso. The effects on estimates of fat mass and lean mass were addressed by providing LSMs of change from baseline.|Week 48|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. Missing values were imputed using LOCF approach.|||gram||Standard Error|Least Squares Mean
2687000|NCT01345630|Secondary|Absolute Change in CD4+/CD8+ Ratio From Baseline to Week 48|The differences in the magnitude of changes in CD4+/CD8+ ratio from Baseline through Weeks 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.|||Ratio||Standard Deviation|Mean
2687001|NCT01345630|Secondary|Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD8 (%)|The differences in the magnitude of changes in CD8+ cell counts from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.|||Percentage of lymphocytes||Standard Deviation|Mean
2687002|NCT01345630|Secondary|Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 8 (CD8, Cell/mm^3)|The differences in the magnitude of changes in CD8+ cell counts from baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.|||cell/mm^3||Standard Deviation|Mean
2687003|NCT01345630|Secondary|Percent Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Activation Marker CD4 (%)|The differences in the magnitude of changes in CD4+ from Baseline through Week 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.|||Percentage of lymphocytes||Standard Deviation|Mean
2687004|NCT01345630|Secondary|Absolute Change From Baseline in Immune Cell Function at Week 48: Lymphocyte Marker Cluster of Differentiation 4 (CD4, Cell/mm^3)|The differences in the magnitude of changes in CD4+ at Baseline and at Week 48 for maraviroc versus emtricitabine/tenofovir were compared.|Baseline, Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. Missing values were imputed using LOCF approach. Baseline was calculated as the average of all the pre-dose measurements excluding the screening value. If all pre-dose values were missing, screening value was considered as the baseline.|||cell/mm^3||Standard Deviation|Mean
2687100|NCT01344876|Primary|Subjects With Treatment Emergent Adverse Events|Treatment emergent adverse events observed during outcome measure time frame. A Treatment Emergent Adverse Event was defined as an AE occurring after the start of IMP administration.|From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)|Safety population No statistical analysis provided for Subjects With Treatment Emergent Adverse Events.|||participants|||Number
2687005|NCT01345630|Secondary|Number of Participants With Resistance to Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTI), Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI), and Protease Inhibitors (PI) in Participants Meeting PDTF Criteria|For participants meeting the PDTF criteria, viral resistance (both genotypic and phenotypic) to NRTI, NNRTI, and PI's were assessed at Baseline and on-treatment. The assessment was performed using the overall (i.e. net) susceptibility score provided using the PhenoSense GT assay. The number of participants with successful assessments were 15/17 for the MVC+DRV/r arm and 3/3 for the FTC/TDF+DRV/r arm.|Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. The assessment was performed using the overall (ie. net) susceptibility score provided using the PhenoSense GT assay. The number of participants with successful assessments were 15 for the MVC+DRV/r arm and 3 for the FTC/TDF+DRV/r arm.|||participants|||Number
2687006|NCT01345630|Secondary|Number of Participants With Viral Resistance to Maraviroc (Maraviroc Treated Participants Only) in Participants Meeting PDTF Criteria.|For participants meeting the PDTF criteria, viral resistance to maraviroc for maraviroc treated participants was assessed in patients with R5 virus at failure. The resistance level is calculated by reference to a laboratory strain of virus that is analyzed in parallel with the clinical isolate to identify 50% inhibitory concentrations (IC50). The maximal percent inhibition is the percent inhibition that is achieved in a titration of the drug at high concentrations when the addition of more drug does not result in increased inhibition. Maximal percent inhibition is obtained in the same way as the titration for IC50, but the key measure is of the plateau height of percent inhibition, where increased concentration of maraviroc does not result in additional inhibition. This is consistent with the virus developing some ability to use maraviroc-bound CCR5 for entry. A significant change in IC50 is not required for this mechanism.|Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug.|||participants|||Number
2687007|NCT01345630|Secondary|Tropism Change Between Screening or Baseline and PDTF|For participants meeting the PDTF criteria, tropism was assessed using the original randomized and alternate assays (ie, both genotype testing and ESTA). Data reported here corresponds to the timepoint at or after PDTF.|Week 48|Number of Evaluable PDTF = Virology Analysis Population (VAP) 'Evaluability' is determined by the on-treatment viral load (≥400 copies/mL at sample time point).|||participants|||Number
2687008|NCT01345630|Secondary|Virologic Outcomes at Week 48 Using Protocol-Defined Treatment Failure (PDTF).|Per the protocol participants who meet the following criteria were regarded as PDTFs requiring a confirmatory plasma HIV-1 RNA determination: • Decrease in plasma HIV-1 RNA <1 log10 from baseline after Week 4 unless plasma HIV-1 RNA is <50 copies/mL, or • Plasma HIV-1 RNA >1.0 log10 above the nadir value after Week 4 where the nadir is the lowest plasma HIV-1 RNA concentration, or • Plasma HIV-1 RNA ≥50 copies/mL at any time after Week 24, or • Plasma HIV-1 RNA ≥50 copies/mL after suppression to <50 copies/mL on two consecutive visits, or • Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <400 copies/mL. Decrease in plasma HIV-1 RNA ≤2 log10 from baseline on or after Week 12 unless plasma HIV-1 RNA is <50 copies/mL (before August 30 2012) or <400 copies/mL (after August 30 2012).|Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug. No imputation for missing values was performed for this endpoint. 'Evaluability' is determined by the on-treatment viral load (≥400 copies/mL at sample time point).|||Number of participants|||Number
2687009|NCT01345630|Secondary|The Relationship Between the Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL at the Week 48 and the Screening Tropism Test (Genotype Test or ESTA).|The relationship of the proportion of participants achieving HIV-1 RNA <50 copies/mL at Week 48 with the screening tropism test for the MVC containing regimen was analyzed. Virologic response for a participant at Week 48 was derived using the FDA's Snapshot MSDF algorithm. Difference in proportions of patients with plasma HIV-1 RNA <50 copies/mL at week 48 between the maraviroc and the emtricitabine/tenofovir treatment arms, with two-sided 95% confidence interval, among patients who are R5 by genotype (including some who were originally randomized to ESTA and are R5 by genotype upon retesting), were calculated via the Maximum Likelihood method. The estimate was adjusted for the screening plasma HIV RNA level (<100,000 vs. ≥100,000) copies/mL via the Mantel Haenszel (MH) method.|Week 48|The FAS consisted of all randomized participants who received at least one dose of the study drug.|||proportion of participants|||Number
2687010|NCT01345630|Secondary|Severity of Abnormal Laboratory Values|Number of participants who had clinically significant laboratory abnormalities of Grade 3 and Grade 4 according to DAIDS. Abnormality incidence of highest grade was reported for a labcode for each individual participant.|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.|||participants|||Number
2687011|NCT01345630|Secondary|Number of Participants With Abnormal Laboratory Values|Number of participants with laboratory abnormalities are reported|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment. One participant was not analyzed for laboratory data as the collection date for all lab data was less than the first active therapy date.|||participants|||Number
2687012|NCT01345630|Secondary|Number of Participants With Treatment-emergent Serious Adverse Events|Total number of participants with treatment-emergent serious adverse events are reported|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.|||participants|||Number
2687013|NCT01345630|Secondary|Number of Treatment-related AEs|Number of treatment-related AEs are presented here.|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.|||events|||Number
2687014|NCT01345630|Secondary|Number of Participants Who Discontinued Due to AEs|Number of participants who discontinued due to AEs are reported here. Three participants (two from the MVC+DRV/r arm and one from the FTC/TDF+DRV/r arm) were not considered as discontinued due to AE because other reasons for discontinuation were prioritized for these participants.|Week 96|Safety Analysis Set was the same as the FAS consisting of all randomized participants who received at least one dose of the study drug but analyzed as realized for tropism assay and treatment.|||participants|||Number
2687017|NCT01345630|Primary|Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL.|"The proportion of participants who achieved HIV-1 RNA <50 copies/mL at week 48 was assessed according to Food and Drug Administration's (FDA's) Missing, Switch, Discontinuation'=Failure (MSDF) Snapshot algorithm. The algorithm used the plasma HIV-1 RNA in the Week 48 visit window, followed the virology-first principle and considers a participant who has a missing plasma HIV-1 RNA, or switches to prohibited ARV regimen or discontinues from the study or study drug for any reason, or dies, as a failure."|Week 48|The Full Analysis Set (FAS) consisted of all randomized participants who received at least one dose of the study drug. The missing value was imputed per FDA’s MSDF Snapshot algorithm as described under “Outcome Measure Description” above.|||Percentage of participants|||Number
2687018|NCT01345591|Secondary|SWAP, COPE and CSQ-8|three questionnaires were evaluated: 1) SWAP (satisfaction with appearance scale) is a psychological test for personality diagnosis and clinical case formulation; 14 questions are asked on a scale of 0-7 where 7 indicates descriptive of the subjects and 0 is irrelevant to the subject for a total score range of 0-98. 2) COPE scale assesses a broad range of coping responses over 28 questions scaled from 1-4 with a total score range of 28-112 where the higher score indicates higher frequency of coping mechanisms used by the subject. 3) CSQ-8 assesses patient satisfaction with the treatment through 8 questions ranked 1-4 on a total scale from 8-32 where higher scores indicate greater satisfaction.|as assessed at baseline, 7-21 days, 3 months and 9 months post op.||||units on a scale||Standard Deviation|Mean
2687019|NCT01345591|Primary|Volume|fat graft volume|3 months and 9 months post op.||||milliliters||Standard Deviation|Mean
2687020|NCT01345513|Secondary|Patient and Physician Experience|Qualitative and quantitative responses on questionnaires and personal interviews regarding patient and physician experience of this research process and their understanding of genomic analysis including perceptions of benefit versus disadvantages, impact on clinical care and decision making|All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.|Data were not collected.||||||
2687021|NCT01345513|Secondary|Number of Participants With Adverse Events Due to Tumor Biopsies on Study|Number of participants with any adverse events possibly, probably or definitely related to tumor biopsies on study; Grading by CTCAE version 4 of adverse events.|All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.|Of the 49 patients analyzed, 8 experienced adverse events related to tumour biopsies during the study. Minor events included bruising, bleeding and minor infections. Serious events included pneumothorax and cellulitis.|||Participants|||Count of Participants
2687022|NCT01345513|Secondary|Number of Participants With Actionable Genomic Results|Number of participants with actionable genomic results (defined as having the potential to impact on management recommendations based on diagnostic, prognostic and/or predictive implications), expressed as a percentage of the total number of study participants.|All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.||||Participants|||Count of Participants
2687023|NCT01345513|Primary|Time From Patient Recruitment to Final Results ≤ 21 Days in ≥ 90% of Patients|Average and range of time (in calendar days) that occurred between study participants providing informed consent to the reporting of genomic results to the physician.|All patients will be followed for up to 2 years from study enrolment, or death, or whichever event occurs first.||||calendar days||Full Range|Mean
2687024|NCT01345318|Primary|Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)|Samples were analyzed using the semi-quantitative electrochemiluminescent (ECL) immunoassay method, a validated analytical method in compliance with sponsor's standard operating procedures. ADA positive is defined as ADA titer greater than or equal to (>=) 4.32. Any positive ADA sample was further tested for NAbs.|At Baseline and Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 and 76.|The safety analysis set was defined as all participants who received at least one dose of PF-04236921during the study.|||percentage of participants|||Number
2687025|NCT01345318|Primary|Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs|An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Lack of efficacy was reported as an AE when it was associated with a SAE. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs.|Baseline up to Week 48|The safety analysis set was defined as all participants who received at least one dose of PF-04236921during the study.|||participants|||Number
2687026|NCT01345292|Secondary|Global Subjective VAS Score at Week 4|"At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2687042|NCT01345240|Secondary|Number of Subjects With Any and Fatal Serious Adverse Events (SAEs) From Day 0 to Month 8|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.|From Day 0 to Month 8|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2687027|NCT01345292|Secondary|Global Subjective VAS Score at Week 2|"At each visit, participants rated their perception of the pain/discomfort experienced by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. Participants were instructed as follows: Please rate the intensity of the pain/discomfort you have experienced in the last two weeks when drinking cold/hot beverages and/or foods, eating sweet and sour foods, breathing cold air, brushing your teeth or performing any habits/behaviors that solicit your dentinal hypersensitivity pain/discomfort since you first started using the product. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm."|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2687028|NCT01345292|Secondary|Mean Cold Air Stimulus VAS Score at Week 4|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2687029|NCT01345292|Secondary|Mean Cold Air Stimulus VAS Score at Week 2|Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2687030|NCT01345292|Secondary|Mean Tactile Sensitivity VAS Score at Week 4|Tooth sensitivity was measured using a VAS. At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2687031|NCT01345292|Secondary|Mean Tactile Sensitivity Visual Analog Scale (VAS) Score at Week 2|Tooth sensitivity was measured using a VAS. At each visit, participants rated their perception of the pain/discomfort experienced from the Yeaple probe by marking a single vertical line on a VAS scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The investigator recorded a VAS score of 0 mm for participants who did not experience discomfort at the maximum force of 80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||units on a scale (mm)||Standard Error|Least Squares Mean
2687032|NCT01345292|Primary|Mean Tactile Sensitivity Score at Week 2|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|2 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||grams of force||Standard Error|Least Squares Mean
2687033|NCT01345292|Primary|Mean Tactile Sensitivity Score at Week 4|Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant.|4 weeks|Analysis was based on the Intent-to-Treat (ITT) analysis set, defined as all randomized participants who used at least one dose of the study product and had baseline and at least one post-baseline efficacy assessment.|||grams of force||Standard Error|Least Squares Mean
2687034|NCT01345253|Secondary|Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase|SRI response is a composite index, defined as the percent of participants with >=4 point reduction from Baseline in SELENA SLEDAI score and no worsening (increase of < 0.30 points from Baseline) in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at time of assessment. Excludes participants with a SELENA SLEDAI score <4 at baseline. Participants randomized to belimumab in double-blinded (DB) phase, Baseline is last available value before first belimumab dose received in DB phase. Participants randomized to placebo in DB phase, Baseline is last available value before receiving first belimumab dose in OL phase. Observed case data are presented.Year 6 Week 48 is the Exit Visit obtained by slotting the Exit Visit to Week 48. A SELENA SLEDAI score of 0 (no lupus activity) and a score of 105 (maximum). PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range.|Weeks 24 and 48 for Years 2, 3, 4, 5 and 6|Efficacy Population: all participants in China who received at least 1 dose of belimumab during open-label phase, exclusive of site 086485. Only those participants available at the specified time points were analyzed (represented by n=x).|||Percentage of participants|||Number
2695946|NCT01274559|Secondary|Percent Change From Baseline in HDL-C at Week 12||Baseline and Week 12|Study was terminated. Efficacy endpoints were not summarized and no planned efficacy analyses were performed.||||||
2687035|NCT01345253|Secondary|Time to First Severe SLE Flare Index (SFI) Flare Over 52 Weeks for Double-blind Phase.|Time to first severe SLE flare is defined as the number of days from first treatment until the participant had an event (event date-treatement start date +1). If a participant had a severe SFI flare and received protocol restricted medication then the event date was the earliest of the first severe SFI flare date, and the treatment failure date. Analysis of severe SFI flare was performed on the modified SELENA SLEDAI SLE flare index in which the modification excluded severe flares that were triggered only by an increase in SELENA SLEDAI score to >12. Analysis was from Cox proportional hazards model for the comparison between belimumab and placebo adjusting for country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).|52 weeks|MITT Population|||Days||Inter-Quartile Range|Median
2687036|NCT01345253|Secondary|Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Reduced by 50 Percent From Baseline Over 52 Weeks for Double-blind Phase.|Number of days of daily prednisone dose <=7.5 mg/day and/or reduced by 50 percent over time through each scheduled visit during the blinded period were compared between belimumab and placebo using Rank ANCOVA model which was used for comparing belimumab and placebo. The independent variables in the model included treatment group, Baseline prednisone dose level, country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4). This analysis was perfomed on the participants who used prednisone >7.5 mg/day at Baseline.|Week 52|MITT Population|||Days||Inter-Quartile Range|Median
2687037|NCT01345253|Secondary|Percent of Participants With SRI7 Response at Week 52 for Double-blind Phase.|SRI7 response is defined as the percent of participants with >=7 point reduction from Baseline in SELENA SLEDAI score and no worsening (increase of < 0.30 points from Baseline) in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).|Baseline (Day 0) and Week 52|MITT Population. Only those participants available at the specified time point were analyzed.|||Percentage of participants|||Number
2687038|NCT01345253|Secondary|Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52 for Double-blind Phase.|The SELENA SLEDAI score is a weighted index for assessing SLE disease activity in which signs and symptoms, laboratory tests and physician's assessment for each of 9 organ system were given a weighted score and summed if present at the time of the visit or in the preceding 10 days. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. A decrease of 4 points or more equates to a clinically meaningful improvement. The Baseline value of a variable is defined as the value of the variable measured at Day 0 prior to dosing. In case of multiple results on Day 0 prior to dosing, the latest result was used. If a Day 0 value was not available, the last available value prior to Day 0 was used.|Baseline (Day 0) and Week 52|MITT Population. Only those participants available at the specified time points were analyzed.|||Percentage of participants|||Number
2687039|NCT01345253|Primary|Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase.|SRI response is a composite index, defined as the percent of participants with >=4 point reduction from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score and no worsening (increase of < 0.30 points from Baseline) in physicians global assessment (PGA) and no new British isles lupus assessment group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).|Week 52|Modified Intention-to-Treat (MITT) Population: all participants who were randomized and treated with at least one dose of study treatment, with exclusion of participants from the site 086485.|||Percentage of participants|||Number
2687040|NCT01345240|Secondary|Number of Subjects With Any, Fatal and Related Serious Adverse Events (SAEs) From Day 0 up to Study End (Month 51)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject. A related SAE was defined as a SAE assessed by the investigator as being causally related to vaccination.|From Day 0 up to Study End (Month 51)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2687041|NCT01345240|Secondary|Number of Subjects With Any and Fatal Serious Adverse Events (SAEs) From Day 0 to Month 26|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.|From Day 0 to Month 26|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2687070|NCT01345188|Primary|Quality of Life|"Quality of life as measured by the Seattle Angina Questionnaire as a score ranging from 0 to 100. Higher score indicates better quality of life. The Qaulity of life is scored by the patient. It assesses the perceived satisfaction or dissatisfaction in the major domains of life.~These include mobility, self-care, Usual activities (leisure, work, family), Pain/Discomfort, and Anxiety."|12 weeks||||units on a scale||Full Range|Mean
2696458|NCT01270529|Primary|Change in Physical Activity|Participants will measure physical activity in the form of daily steps using a pedometer|Baseline, 12 weeks||||change in steps per day||95% Confidence Interval|Mean
2687043|NCT01345240|Secondary|Number of Subjects With Any and Fatal Serious Adverse Events (SAEs) Within the 30-day Follow-up Periods (Days 0-29)|A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.|Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2687044|NCT01345240|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs)|An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2687045|NCT01345240|Secondary|Number of Subjects With Potential Immune Mediated Disorders (pIMDs) From Day 0 up to Study End (Month 51)|A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison's disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.|From Day 0 up to Study End (Month 51)|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2687046|NCT01345240|Secondary|Number of Subjects With Potential Immune Mediated Disorders (pIMDs) From Day 0 to Month 26|A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison's disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.|From Day 0 to Month 26|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2687047|NCT01345240|Secondary|Number of Subjects With Potential Immune Mediated Disorders (pIMDs) From Day 0 to Month 8|A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison's disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.|From Day 0 to Month 8|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.|||Participants|||Count of Participants
2687048|NCT01345240|Secondary|Number of Subjects With Solicited General Symptoms|Assessed solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. Fever was defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C). Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited general symptoms, that is, the occurrences of these symptoms regardless of their intensity grade or relationship to vaccination.|Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled-in.|||Participants|||Count of Participants
2687049|NCT01345240|Secondary|Number of Subjects With Solicited Local Symptoms|Assessed solicited local symptoms were pain, redness and swelling at the site of injection. All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination. Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited local symptoms, that is, the occurrences of these symptoms regardless of their intensity grade.|Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B vaccine|The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled-in.|||Participants|||Count of Participants
2687071|NCT01345188|Primary|Anginal Frequency|Anginal frequency as assessed by Seattle Angina Questionnaire. Scoring is done by assessing responses on an ordinal value. Anginal score is scored by the patient by selecting a number from 0 to 100 with low score indicates more anginal frequency. The mean of the the scores of all patients analyzed were compared between placebo and Ranolazine.|12 weeks|Patients receiving ranolazine for 6 weeks and crossed over to placebo or vice versa. Higher number on the angina scale indicates less angina|||units on a scale||Full Range|Mean
2687072|NCT01345162|Secondary|Development of Persistent Postoperative Pain|Assessment of pain prevalence and presentation of persistant postoperative pain. Evaluation of all the patients after 1 and 3 months by phone call and with clinical re-evaluation in all patients who referred pain.|Up to 3 months|||||||
2687050|NCT01345240|Secondary|Anti-Rotavirus (Anti-RV) Antibody Concentrations|Anti-Rotavirus (anti-RV) antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs). The cut-off of the assay was the seropositive cut-off value of greater than or equal to (>=) 20 units per milliliter (U/mL). This outcome measure was assessed in subjects who were administered Rotarix as part of an EPI regimen, with and without RTS,S vaccine co-administration. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Rotarix. Results presented are for the study groups pooled by RTS,S or Engerix-B vaccine co-administration, that is, for the RTS,S Regimen B and Engerix-B Regimen B groups.|At Month 3, aka one month post Dose 2 of Rotarix|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||U/mL||95% Confidence Interval|Geometric Mean
2687051|NCT01345240|Secondary|Concentrations of Antibodies Against Acellular B-pertussis (BPT) at Day 0 and at Month 3|The antibodies against BPT assessed were against pertussis toxoid (anti-PT), against filamentous haemagglutinin (anti-FHA), and against pertactin (anti-PRN). Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to (>=) 5 EL.U/mL. The table shows results for study groups pooled by primary vaccine administered (RTS,S vs Engerix -B)|At Day 0 and at Month 3 (one month post Dose 3 of Infanrix-Hib)|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2687052|NCT01345240|Secondary|Anti-protein D (PD) Antibody Concentrations at Month 17|Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL. This outcome concerns the subjects who received the RTS,S or Engerix -B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix -B Regimen A groups.|At Month 17, aka one month post the Month 16 booster dose of Synflorix|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2687053|NCT01345240|Secondary|Anti-protein D (PD) Antibody Concentrations at Month 3|Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.|At Month 3, aka at one month post Dose 3 of Synflorix|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2687054|NCT01345240|Secondary|Titers for Opsonophagocytic Activity Against Synflorix Pneumococcal Vaccine Serotypes at Month 17|The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution >= 8. This outcome concerns the subjects who received the RTS,S or Engerix -B vaccine co-administered with Synflorix . Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix -B Regimen A groups.|At Month 17, aka one month post the Month 16 booster dose of Synflorix|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Titer||95% Confidence Interval|Geometric Mean
2687055|NCT01345240|Secondary|Titers for Opsonophagocytic Activity Against Synflorix Pneumococcal Vaccine Serotypes at Month 3|The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution >= 8. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.|At Month 3, aka at one month (1M) post Dose 3 of Synflorix|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Titer||95% Confidence Interval|Geometric Mean
2687073|NCT01345162|Secondary|Assessment of Any Connections Between the Two Therapeutical Strategies and the Recurrence of Surgical Complications|"Assessment of the recurrence of surgical complications. Evaluation of all the patients after 5 days by clinical evaluation. After 1 and 3 month in the patients who refer pain.~Assessment of any difference between the two groups."|4 days postherniotomy|||||||
2687074|NCT01345162|Secondary|Difference in Recovering Daily Activity|Assessment of the difference in recovering daily activity in terms of NRSm (Numeric Rate Scale at movement)|4 days after surgical procedure|||||||
2687056|NCT01345240|Secondary|Pneumococcal Antibody Concentrations Against Synflorix Pneumococcal Vaccine Serotypes at Month 17|Antibody concentrations were measured by GSK assay, and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (>=) 0.2 μg/mL. This corresponds to the standard ELISA value of 0.35 μg/mL. This outcome concerns the subjects who received the RTS,S or Engerix -B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix -B Regimen A groups.|At Month 17, aka one month post the Month 16 booster dose of Synflorix|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||μg/mL||95% Confidence Interval|Geometric Mean
2687057|NCT01345240|Secondary|Pneumococcal Antibody Concentrations Against Synflorix Pneumococcal Vaccine Serotypes at Month 3|Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (>=) 0.2 µg/mL. This corresponds to the standard ELISA value of 0.35 μg/mL. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.|At Month 3, aka at one month post Dose 3 of Synflorix|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||µg/mL||95% Confidence Interval|Geometric Mean
2687058|NCT01345240|Secondary|Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations at Month 38 and 50|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 1.9 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups.|At Months 38 and 50, aka 36 and 48 months post Dose 3 of RTS,S vaccine or Engerix-B|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2687059|NCT01345240|Secondary|Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations at Month 14|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 0.5 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups. No anti-CS results are available for the time point 24 months post Dose 3 (Month 26) because the quantity of serum available for the anti-CS assay was insufficient for many samples.|At Month 14, aka at 12 months post Dose 3 of RTS,S vaccine or Engerix-B|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2687060|NCT01345240|Secondary|Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations at Month 3|Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 0.5 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups.|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2687061|NCT01345240|Secondary|Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1) at Month 51|Anti-HBs RF1 antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 33 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups.|At Month 51, aka one month post the Month 50 booster dose of Engerix-B|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2687062|NCT01345240|Secondary|Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1) at Month 3|Anti-HBs RF1 antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 33 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups.|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2687063|NCT01345240|Secondary|Anti-Hepatitis B (HBs) Antibody Concentrations at Month 38, 50 and 51|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups.|At Months 38, 50 and 51, aka 36 and 48 months post Dose 3 of RTS,S vaccine or Engerix-B and one month post the Month 50 booster dose of Engerix-B|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2687064|NCT01345240|Secondary|Anti-Hepatitis B (HBs) Antibody Concentrations at Month 14 and 26|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups.|At Months 14 and 26, aka at 12 and 24 months post Dose 3 of RTS,S vaccine or Engerix-B|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2687065|NCT01345240|Secondary|Anti-Hepatitis B (HBs) Antibody Concentrations at Month 3|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for the study groups receiving the RTS,S vaccine, pooled by vaccine lot, that is, for the RTS,S Lot 1, RTS,S Lot 2, and RTS,S Lot 3 groups, as defined below.|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2687066|NCT01345240|Primary|Anti-Hepatitis B (HBs) Antibody Concentrations for All Study Groups|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, for each RTS,S Regimen A, B, C and each Engerix B Regimen A and B study groups.|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2687067|NCT01345240|Primary|Anti-Hepatitis B (HBs) Antibody Concentrations for RTS,S Group and Engerix B Group|Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by primary vaccine administered (RTS,S vs Engerix-B).|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||mIU/mL||95% Confidence Interval|Geometric Mean
2687068|NCT01345240|Primary|Percentage of Seroprotected Subjects Against Anti-Hepatitis B (HBs) Antigen|A seroprotected subject was defined as a subject with anti-HBs antibody titers greater than or equal to (>=) the cut-off of 10 mili-international units per mililiter (mIU/mL). A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by primary vaccine administered (RTS,S vs Engerix -B).|At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B|The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.|||Percentage of subjects||95% Confidence Interval|Number
2687069|NCT01345188|Primary|Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ)|RDQ is a four item questionnaire that evaluates a patient's dyspnea with regular activity. Each question answered postiviely is given a score of 1. Total score possible is 4. A higher score indicates worse dyspnea. A difference between the score at end of treatment minus baseline is performed. A negative score indicates improvement. Comparing the difference between the 2 arms (placebo and ranolazine) is performed.|12 weeks|Patients with dsypnea. The score reflects difference between baseline and following treatment with ranolazine or placebo|||units on a scale||Full Range|Mean
2687077|NCT01345123|Primary|Total Medical Costs That Can be Impacted Per Member Per Month|"total medical cost paid for covered services for the subject for six months after initiation of the study. This total includes all places of service and types of covered services, including inpatient, outpatient and pharmacy.~Costs that cannot be impacted include: Costs related to Trauma and Accident, Psychiatric/Substance Abuse, Malignant Neoplasm, Maternity and Childbirth excluded"|6 months|Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Institutionalized >= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study.|||Total dollars / member months||95% Confidence Interval|Mean
2687078|NCT01345123|Secondary|Decision Satisfaction|Self-reported measure of subject satisfaction with decision as measured retrospectively, including how subjects feel their decision worked out and whether or not they would make the same decision again.|6 months|||||||
2687079|NCT01345123|Secondary|Decision Conflict|Self-reported measure of the extent to which subjects feel comfortable, supported and confident in choosing one treatment approach over others. Score computed on a scale of 1-3, where 1 = 'No', 2='Yes, somewhat', 3='Yes, completely' (3 indicates less conflict, 1 indicates most conflict) on a 4 item survey question set- asks whether respondents feel sure, have enough support, know and are clear about benefits and risks of treatment options.|12 weeks|Decision Quality Survey administered to a random sample (N=2600) of all study participants in the second study wave (N=4208): 1177 survey-eligible respondents.|||units on a scale||95% Confidence Interval|Mean
2687080|NCT01345123|Secondary|Knowledge|Subject self-reported knowledge about the risks and benefits of surgical options and likely outcomes with and without surgical interventions.Knowledge score calculated (score of 0-5, counting number of correct answers) for every respondent who completes at least 3 of the 5 items.|12 weeks|Decision Quality Survey administered to a random sample (N=2600) of all study participants in the second study wave (N=4208): 1177 survey-eligible respondents, 1124 received a knowledge score.|||number of correct answers||95% Confidence Interval|Mean
2687081|NCT01345123|Secondary|Quality of Decision Making Process|Self-reported measure of the extent to which subject interactions with providers involve discussions of the pros and cons of treatment options and provide an opportunity for subjects to have input into the decisions.|6 months|||||||
2687082|NCT01345123|Secondary|Concordance|Self-reported consistency of choices with goals and concerns--extent to which the treatment choices subjects make are or are not consistent with the issues they state are priorities including avoiding surgery, reducing pain and regaining function|6 months|||||||
2687083|NCT01345123|Secondary|Rate of Targeted Conditions Surgeries|rate of any one claims based instance of lumbar back, hip repair, hip replacement, knee repair, or knee replacement surgery|6 months|Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Institutionalized >= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study.|||percentage of participants|||Number
2687084|NCT01345123|Primary|Total Medical Costs Per Member Per Month|total medical cost paid for covered services for the subject for six months after initiation of the study. This total includes all places of service and types of covered services, including inpatient, outpatient and pharmacy.|6 months|Excluded: Subjects with claim for study-related surgery prior to intervention,claims evidence of symptomatic AIDS, organ transplant, on dialysis, Instituted >= 30days for psych. Subjects with less than 6 months of health plan eligible months. Spinal Stenosis not eligible for study.|||Total dollars / member months||95% Confidence Interval|Mean
2687085|NCT01345058|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence (side effect) in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event that occurs after receiving the drug.|6 Months|All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.|||Participants|||Count of Participants
2687086|NCT01345058|Secondary|Retention Rate|Retention rate is defined as the percentage of participants who remained on the study drug after study completion.|6 Months|All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.|||percentage of participants|||Number
2687087|NCT01345058|Secondary|Time to First Seizure After Therapeutic Dose is Reached|Time in days until the first seizure after the therapeutic dose is reached occurs.|6 Months|All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.|||days||Full Range|Median
2687088|NCT01345058|Secondary|Number of Seizure-Free Days||6 Months|All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.|||days||Standard Deviation|Mean
2687089|NCT01345058|Primary|Percentage of Participants Achieving Six Month Seizure Freedom|Seizure freedom is defined as having no seizures and was evaluated in the 6 month period after receiving the drug.|6 Months|All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis.|||percentage of participants|||Number
2687090|NCT01345019|Secondary|Percentage of Participants Who Died||From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2687091|NCT01345019|Secondary|Overall Survival|Overall survival was defined as the time interval (in days) from the randomization date to the date of death. If a participant was still alive at the primary analysis data cut-off date or was lost to follow-up by the primary analysis data cut-off date, survival time was censored at their last contact date or the primary analysis data cut-off date, whichever was first.|From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.|All randomized participants|||days||95% Confidence Interval|Median
2697165|NCT01263717|Secondary|Lipid Panel|Fasting lipids. Triglyceride value is given.|6 months|All available data were used; data were not available for one subject.|||Change in triglyceride, mg/dL||Inter-Quartile Range|Median
2687092|NCT01345019|Secondary|Time to First and Subsequent On-Study Skeletal Related Event - Number of Events|"A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE. Time to a subsequent SRE is defined, similarly to the time to first on-study SRE, as the time interval from the randomization date to the date of a subsequent occurrence of on-study SRE, which had to be at least 21 days after the previous SRE.~A multiple event analysis was used, which accounts for both the absolute number of SREs and for the time between two consecutive events, and therefore, provides a more sensitive assessment of the risk of experiencing an SRE. The total number of events is reported."|From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.|All randomized participants|||skeletal-related events|||Number
2687093|NCT01345019|Secondary|Time to First and Subsequent On-Study Skeletal Related Event - Number of Events Per Patient|"A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE. Time to a subsequent SRE is defined, similarly to the time to first on-study SRE, as the time interval from the randomization date to the date of a subsequent occurrence of on-study SRE, which had to be at least 21 days after the previous SRE.~A multiple event analysis was used, which accounts for both the absolute number of SREs and for the time between two consecutive events, and therefore, provides a more sensitive assessment of the risk of experiencing an SRE. The average number of events per patient is reported."|From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.|All randomized participants|||events/patient|||Number
2687094|NCT01345019|Secondary|Time to First On-study Skeletal Related Event - Superiority Analysis|A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE. If there was no known event, and the participant was monitored for any one of the four SRE components, time to first on-study SRE was censored at the end of the treatment phase date or the primary analysis data cut-off date, whichever came first.|From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.|All randomized participants|||days||95% Confidence Interval|Median
2687095|NCT01345019|Primary|Kaplan-Meier Estimate of Percentage of Participants With an On-study Skeletal Related Event|A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.|From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively. The Kaplan-Meier estimate at weeks 25, 49 and 109 is reported.|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2687096|NCT01345019|Primary|Percentage of Participants With an On-study Skeletal Related Event|A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.|From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.|All randomized participants|||percentage of participants||95% Confidence Interval|Number
2687097|NCT01345019|Primary|Time to First On-study Skeletal Related Event|A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE. If there was no known event, and the participant was monitored for any one of the four SRE components, time to first on-study SRE was censored at the end of the treatment phase date or the primary analysis data cut-off date, whichever came first.|From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.|All randomized participants|||days||95% Confidence Interval|Median
2687098|NCT01344876|Primary|Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)|DLT was defined as adverse events occurring during Cycle 1 and: (1) Grade 3 or higher nausea, vomiting, or diarrhea despite the use of anti-emetic or antidiarrheal drugs, (2) Grade 3 or higher non-hematologic toxicity, excluding alopecia, (3) AEs requiring interruption of the IMP for a total of 8 days or longer, (4) Grade 4 neutropenia lasting ≥ 8 days (not applicable for leukemia), (5) Grade 3 or higher febrile neutropenia or infection due to neutropenia (not applicable for leukemia), (6) Grade 4 thrombocytopenia or Grade 3 thrombocytopenia requiring platelet transfusion (not applicable for leukemia).|From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)|DLT evaluated subjects who had achieved ≧75% study drug compliance during a 4-week (28-day) treatment period starting from Day 4. No statistical analysis provided for Subjects With DLTs.|||participants|||Number
2687099|NCT01344876|Secondary|Treatment Response|"Assessment of the treatment response was evaluated according to internationally recognized response criteria for multiple myeloma, non-Hodgkin's lymphoma, acute myeloid leukemia, chronic myeloid leukemia.~Response was defined as at least partial response or partial remission (PR) according to the criteria for efficacy assessment."|From first dose of study medication to withdrawal examination|"Efficacy population included all treated subjects who had received at least 1 dose of study drug.~No statistical analysis provided for treatment response."|||participants|||Number
2687101|NCT01344824|Secondary|Subjects Experiencing Toxicity|Toxicity will be evaluated using CTCAE criteria, version 3, all grade 3 and 4 events.|90 days|All patients who received treatment were evaluated|||participants|||Number
2687102|NCT01344824|Secondary|Overall Survival|Time of enrollment to date of death.|1400 days||||months||95% Confidence Interval|Median
2687103|NCT01344824|Primary|Progression-free Survival|Documented radiographic response per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. criteria each year, until subject death|1400 days||||months||95% Confidence Interval|Median
2687104|NCT01344759|Secondary|Room Air SpO2|The patient's oxygen saturation on room air.|During MRI and until recovery room discharge - approximately 30-250 minutes||||percentage of SpO2||Inter-Quartile Range|Mean
2687105|NCT01344759|Secondary|Needed Artificial Airway|This is the count of the number of patients who needed an artificial airway.|During MRI and until recovery room discharge - approximately 30-250 minutes||||Number of artifical airway events|||Number
2687106|NCT01344759|Secondary|Respiratory Disturbance Index|The respiratory disturbance index is a count of respiratory disturbance events per hour of sleep.|During MRI and until recovery room discharge - approximately 30-250 minutes||||respir.disturbance events/hr of sleep||Inter-Quartile Range|Mean
2687107|NCT01344759|Secondary|Obstructive Index Until Recovery Room Discharge|The Obstructive Index is a count of the obstructive apnea events per hour of sleep|During MRI and until recovery room discharge - approximately 30-250 minutes||||Apnea events/hour of sleep||Inter-Quartile Range|Mean
2687108|NCT01344759|Primary|Cross Sectional Area of the Pharyngeal Airway|The primary outcome measures will be the cross sectional area of the pharyngeal airway of the patients measured at two levels soft palate (nasopharyngeal) and base of the tongue (retroglossal). Magnetic resonance images of the airway were obtained during low (1 mcg/kg/hr) and high (3 mcg/kg/hr) doses of DEX or low (100 mcg/kg/m) and high (200 mcg/kg/m) doses of Propofol. All were administered through an intravenous (IV) catheter.|during MRI within first 10 minutes of scanning||||mm^2||95% Confidence Interval|Median
2687109|NCT01344629|Secondary|MRTpo|mean residence time of Telmisartan in the body after oral administration|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.|||hour||Geometric Coefficient of Variation|Geometric Mean
2687110|NCT01344629|Secondary|t1/2|terminal half-life of Telmisartan in plasma|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.|||hour||Geometric Coefficient of Variation|Geometric Mean
2687111|NCT01344629|Secondary|λz|terminal rate constant of Telmisartan in plasma|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.|||/hour||Geometric Coefficient of Variation|Geometric Mean
2687112|NCT01344629|Secondary|Tmax|time from dosing to the maximum concentration of Telmisartan in plasma|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. Therefore, the number of observed PK parameter were 32+32+31+31=126 in T80/A5 FDC tablet and T80 + A5, respectively.|||hour||Full Range|Mean
2687113|NCT01344629|Secondary|AUC0-∞|area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 extrapolated to infinity|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.|||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2687114|NCT01344629|Primary|Cmax|maximum measured concentration of Telmisartan in plasma|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. Therefore, the number of observed PK parameter were 32+32+31+31=126 in T80/A5 FDC tablet and T80 + A5, respectively.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2687115|NCT01344629|Primary|AUC0-tz|Area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point|Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration|One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. Therefore, the number of observed PK parameter were 32+32+31+31=126 in T80/A5 FDC tablet and T80 + A5, respectively.|||ng*hour/mL||Geometric Coefficient of Variation|Geometric Mean
2687116|NCT01344616|Secondary|Gestational Weight||9 months|||||||
2687117|NCT01344616|Primary|Birthweight|Birth weight < 2500 grams|9 months|One Set of twins in the lifestyle counseling arm and 4 sets of twins in the usual clinical care arm|||participants|||Number
2687118|NCT01344538|Primary|Evaluate Whether 2.0g of Ginger Taken Daily, Standardized to 5%-Gingerols for Four Weeks Will Result in Bioactive Levels in Colonic Tissue Sufficient to Reduce Mucosal Prostaglandin E2 (PGE2), a Marker of Cyclooxygenase Function Versus Placebo.|% Change between baseline and day 28 in PGE2 levels standardized by protein|Baseline and day 28||||percentage of change from baseline||Standard Deviation|Mean
2687119|NCT01344460|Secondary|Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|FAS with participants who were recommended for additional imaging studies.|||participants|||Number
2687164|NCT01344369|Primary|AUC0-inf of Norethindrone|Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2687120|NCT01344460|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 3|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|FAS with participants who were recommended for additional imaging studies.|||participants|||Number
2687121|NCT01344460|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 2|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|FAS with participants who were recommended for additional imaging studies.|||participants|||Number
2687122|NCT01344460|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images - Blinded Reader 1|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|FAS with participants who were recommended for additional imaging studies.|||participants|||Number
2687123|NCT01344460|Secondary|The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Gadobutrol-Enhanced and Unenhanced MRA Images|A measure of diagnostic value was the reduction in the number of additional diagnostic imaging studies recommended/ordered. The clinical investigators and the blinded readers were asked if they had recommended an additional imaging study for each participant, and the data were recorded.|Images were taken pre-injection and post-injection|FAS|||percentage of participants|||Number
2687124|NCT01344460|Secondary|Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Diagnostic confidence was evaluated to determine the level of certainty that the blinded readers assigned to a diagnosis for each segment. This was defined as the degree of confidence that the information on the MRA images represented the true and complete clinical picture of a particular segment. The degree of confidence was rated on a 4-point scale: 1=Not confident; 2=Somewhat confident; 3=Confident; 4=Very confident.|Images were taken pre-injection and post-injection|"FAS; In the below table, n signifies the number of segments that were evaluable in specified category."|||Units on scale||Standard Deviation|Mean
2687125|NCT01344460|Secondary|The Percentage of Participants With Diagnosis of Fibromuscular Dysplasia and Arteriosclerosis Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|Any focal dilatation (aneurysmal dilatation) of a segment was recorded. The diameter at the widest point was measured with the electronic calipers if a dilatation was present in any segment. The number of participants with an aneurysmal dilatation in each segment (proximal, mid- and distal) in the right and the left renal arteries assessed by gadobutrol-enhanced MRA and unenhanced MRA were reported.|Images were taken pre-injection and post-injection|FAS|||percentage of participants|||Number
2687126|NCT01344460|Secondary|The Presence of Any Aneurysmal Dilatation in Each Segment (Proximal, Mid- and Distal) in the Right and the Left Renal Arteries Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|Any focal dilatation (aneurysmal dilatation) of a segment was recorded. The diameter at the widest point was measured with the electronic calipers if a dilatation was present in any segment. The number of participants with an aneurysmal dilatation in each segment (proximal, mid- and distal) in the right and the left renal arteries assessed by gadobutrol-enhanced MRA and unenhanced MRA were reported.|Images were taken pre-injection and post-injection|FAS|||percentage of participants|||Number
2687127|NCT01344460|Secondary|The Percentage of Accessory (Non-dominant) Renal Artery Presence Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|An accessory renal artery was defined as an additional, non-dominant, renal artery typically emanating from the aorta and anastomosing distal to the proximal third, segment of that renal artery. It was recorded only as present or absent on the right and left, regardless of how many accessory renal arteries were present.|Images were taken pre-injection and post-injection|FAS|||percentage of accessory|||Number
2687128|NCT01344460|Secondary|Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 3|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.|||percentage of segments|||Number
2687129|NCT01344460|Secondary|Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 2|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.|||percentage of segments|||Number
2687130|NCT01344460|Secondary|Types of Artifacts Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA by Blinded Reader 1|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifact presence.|||percentage of segments|||Number
2687131|NCT01344460|Secondary|The Percentage of Segments With Artifacts Presence|Artifacts were collected for the MRA images on a segmental basis.|Images were taken pre-injection and post-injection|Evaluable participants in FAS|||percentage of segments|||Number
2687165|NCT01344369|Primary|AUC0-t of Norethindrone|Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2687132|NCT01344460|Secondary|The Percentage of Location of Stenosis >= 50% (Within and Beyond 5 Millimeter From the Aorta) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|Location within the right and left proximal segment was based on the point of greatest stenosis and was recorded for stenosis >=50% as: - Within 5 mm of the aorta (or occlusion proximal to the origin of the segment); - Beyond 5 mm from the aorta.|Images were taken pre-injection and post-injection|"Participants in FAS that were evaluable; in below table, n signifies the number of segments that were evaluable in specified category."|||Percentage of location|||Number
2687133|NCT01344460|Secondary|Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images|The segment reduction in diameter (DIA) of greater than 10% was considered abnormal and measured. The diameter of each of these abnormal segments was measured using electronic calipers (perpendicular to the long axis of the vessel) at the point of most severe stenosis within each segment. Mean of vessel diameters was calculated by segment separately for CTA and MRA readers. For the ease of expression, the following abbreviations will be used: Diameter (DIA), Blinded Reader (BR).|Images were taken pre-injection and post-injection|Evaluable participants in FAS|||mm|Participants|Standard Deviation|Mean
2687134|NCT01344460|Secondary|Length of the Right and Left Renal Arteries Assessed by Computed Tomographic Angiography (CTA) - Blinded Reader|The length of the left and right renal arteries were measured from the origin at the aorta to the bifurcation into the upper and lower pole arteries or the most distal point of the renal artery which could be visualized. This distal margin was the point where the diameter was still assessable. If there were more than 2 distal branches then the first large branch that was the dominant supply to a renal pole was used as the distal point.|Images were taken pre-injection and post-injection|Evaluable participants in FAS|||millimeter(s) (mm)||Standard Deviation|Mean
2687135|NCT01344460|Secondary|Length of the Right and Left Renal Arteries Assessed by Gadobutrol-enhanced MRA and Unenhanced MRA - Blinded Reader|The length of the left and right renal arteries were measured from the origin at the aorta to the bifurcation into the upper and lower pole arteries or the most distal point of the renal artery which could be visualized. This distal margin was the point where the diameter was still assessable. If there were more than 2 distal branches then the first large branch that was the dominant supply to a renal pole was used as the distal point.|Images were taken pre-injection and post-injection|Evaluable participants in FAS|||millimeter(s) (mm)||Standard Deviation|Mean
2687136|NCT01344460|Primary|Minimum Gadobutrol Performance for Specificity: Specificity > 50%|Clinically significant disease (stenosis) was defined as >50% stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."|||percentage of specificity|Participants||Number
2687137|NCT01344460|Primary|Minimum Gadobutrol Performance for Sensitivity: Sensitivity More Than (>) 50%|Clinically significant disease was defined as >50% stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."|||percentage of sensitivity|Participants||Number
2687138|NCT01344460|Primary|Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Clinically significant disease (stenosis) was defined as 50 to 99 percent (%) stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Specificity = percentage of participants for which the imaging modalities (unenhanced or gadobutrol-enhanced) in the detection and exclusion of clinically significant stenosis.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."|||percentage of specificity|Participants||Number
2687139|NCT01344460|Primary|Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Clinically significant disease was defined as 50 to 99 percent (%) stenosis of a segment, but not occluded as assessed by the SoR. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."|||percentage of sensitivity|Participants||Number
2687140|NCT01344460|Primary|Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Each vascular segment was visualized using unenhanced MRA and gadobutrol-enhanced MRA, characterized by the on-site investigators, three independent blinded readers (reader 1, 2 and 3) and majority readers (the outcome determined by at least two of the blinded readers). The segments were predefined to standardize the blinded reader evaluations. A segment was assessable if it was visualized along its entire length and if any region of stenosis, was measured reliably. There were 6 segments assessed per participant (3 segments in the right renal artery and 3 segments in the left renal artery) and up to 9 segments in participants with renal transplant.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category for both groups."|||Percentage of segments|Participants||Number
2687141|NCT01344447|Secondary|Types of Additional Imaging Studies Recommended by the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|Participants in FAS who were recommended for additional imaging studies.|||participants|||Number
2687166|NCT01344369|Primary|Cmax of Norethindrone|Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2687142|NCT01344447|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 3|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|Participants in FAS who were recommended for additional imaging studies.|||participants|||Number
2687143|NCT01344447|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 2|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|Participants in FAS who were recommended for additional imaging studies.|||participants|||Number
2687144|NCT01344447|Secondary|Types of Additional Imaging Studies Recommended by the Blinded Readers After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images - Blinded Reader 1|An additional imaging study recommended was specified from the following list: Non-contrast MRA, Contrast-enhanced MRA, CTA, Ultrasound, Digital subtraction catheter angiogram (DSCA), and Nuclear medicine study.|Images were taken pre-injection and post-injection|Participants in FAS who were recommended for additional imaging studies.|||participants|||Number
2687145|NCT01344447|Secondary|The Percentage of Participants With Additional Imaging Studies Recommended by the Blinded Readers and the Clinical Investigator After Evaluation of the Unenhanced and Gadobutrol-Enhanced MRA Images|A measure of diagnostic value was the reduction in the number of additional diagnostic imaging studies recommended/ordered. The clinical investigators and the blinded readers were asked if they would have recommended an additional imaging study for each participant and was recorded.|Images were taken pre-injection and post-injection|FAS|||percentage of participants|||Number
2687146|NCT01344447|Secondary|Diagnostic Confidence by the Blinded Readers Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Diagnostic confidence was evaluated to determine the level of certainty that the blinded readers assigned to a diagnosis for each segment. This was defined as the degree of confidence that the information on the MRA images represented the true and complete clinical picture of a particular segment. The degree of confidence was rated on a 4-point scale: 1 = Not confident, 2 = Somewhat confident, 3 = Confident, and 4 = Very confident.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in below table, n signifies number of segments that were evaluable for the specified category of each group."|||units on a scale||Standard Deviation|Mean
2687147|NCT01344447|Secondary|Type of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease|Each segment was assessed for secondary signs of stenosis for diagnosis of clinically significant disease. The following indicators were considered for the MRA studies: - post-stenotic dilation or ulceration (segmental), - post-stenotic signal dropout, narrowing and intensity reduction, and - thrombus. Each of the three parameters were assessed as present or absent in the region distal to the stenosis. If they were found in any segment distal to the stenosis then they were assessed as present. If there were tandem (serial) stenosis in a vessel then the secondary signs were assigned to the stenosis of >=70% that was proximal and closest in proximity to the secondary sign.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in below table, n signifies number of segments with presence of secondary radiologic indicators for the specified category of each group."|||percentage of segments|||Number
2687148|NCT01344447|Secondary|The Percentage of Presence of Secondary Radiologic Indicators for Diagnosis of Clinically Relevant Disease|Each segment was assessed for secondary signs of stenosis for diagnosis of clinically significant disease. The following indicators were considered for the MRA studies: - post-stenotic dilation or ulceration (segmental), - post-stenotic signal dropout, narrowing and intensity reduction, and - thrombus. Each of the three parameters were assessed as present or absent in the region distal to the stenosis. If they were found in any segment distal to the stenosis then they were assessed as present.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in below table, n signifies segments that were evaluable for the specified category of each group."|||percentage of radiologic indicator|||Number
2687149|NCT01344447|Secondary|Length of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|The length of stenosis was based on the most proximal (first point) in a segment where a stenosis exceeded 10% and the most distal point (last point) in the segment where a stenosis exceeded 10%. If a stenosis spanned more than one segment then the measurement was only included to the beginning or end (boundary) of the segment being evaluated. If there was no stenosis of >=70% in a segment then the length was designated as 0.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; this outcome measure was analyzed on a segment basis, in the below table, n signifies number of segments that were evaluable for the specified category of each group."|||millimeter(s)||Standard Deviation|Mean
2687150|NCT01344447|Secondary|The Percentage of Location of Stenosis (>=70%) in the Proximal Segments Assessed by Gadobutrol-Enhanced MRA and Unenhanced MRA|Location within a segment was based on the point of greatest stenosis and was recorded for stenosis >=70% (including occlusions) as: - At the bifurcation or proximal origin of a segment (occlusion proximal to the origin of the segment); - Within 5 mm of the bifurcation or proximal origin of a segment; - Beyond 5 mm from the bifurcation or proximal origin of a segment.|Images were taken pre-injection and post-injection|"Evaluable participants in FAS; in the below table, n signifies number of locations that were evaluable for the specified category of each group."|||pecentage of location|||Number
2687151|NCT01344447|Secondary|Types of Artifacts on a Segment Basis by Blinded Reader 3|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.|||percentage of segments|segments||Number
2687167|NCT01344356|Secondary|Overall Survival|Number of participants who are alive 5 years following treatment.|5 years|9 patients did not have overall survival data reported. 3 patients were enrolled but never treated. 6 patients were lost to follow up.|||Participants|||Count of Participants
2687152|NCT01344447|Secondary|Types of Artifacts on a Segment Basis by Blinded Reader 2|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.|||percentage of segments|segments||Number
2687153|NCT01344447|Secondary|Types of Artifacts on a Segment Basis by Blinded Reader 1|The following types of artifacts were considered: Motion artifact (including pulsatility, breathing, swallowing), venous opacification, saturation artifact (for example [eg], in-plane flow, turbulence, dephasing, saturation band), susceptibility artifacts (including devices, eg, stents), ringing artifact (eg, bands), bolus timing error, and other (artifact not specified above or no artifact).|Images were taken pre-injection and post-injection|Participants in FAS with artifacts presence.|||percentage of segments|segments||Number
2687154|NCT01344447|Secondary|The Percentage of Segments With Artifacts Presence|Artifacts were collected for the MRA images on a segmental basis.|Images were taken pre-injection and post-injection|Evaluable participants in FAS|||percentage of segments|segments||Number
2687155|NCT01344447|Secondary|Vessel Diameter (Millimeter [mm]) at the Normal Point and the Narrowest Point in Gadobutrol-Enhanced MRA, Unenhanced MRA and CTA Images|The segment reduction in diameter (DIA) of greater than 10% was considered abnormal and measured. The diameter of each of these abnormal segments was measured using electronic calipers (perpendicular to the long axis of the vessel) at the point of most severe stenosis within each segment. Mean of vessel diameters was calculated by segment separately for CTA and MRA readers. For ease of expression, the following abbreviations will be used: Diameter (DIA), Blinded Reader (BR), Clinical Investigator (CI).|Images were taken pre-injection and post-injection|FAS; Number of participants/segments analyzed in below ordered categories (Normal-BRs; Narrowest-BRs; Normal-CIs; Narrowest-CIs) in Enhanced MRA group was 457/6182, 457/6182, 419/1361, 419/1352 respectively; in Unenhanced MRA group was 455/4776, 455/4776, 367/989, 367/980 respectively; in CTA was 442/3158, 442/3158, 419/1569, 419/1555 respectively.|||millimeter(s) (mm)||Standard Deviation|Mean
2687156|NCT01344447|Primary|Minimum Gadobutrol Performance for Specificity: Specificity > 50%|Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded as assessed by the SoR (CTA; blinded readers). For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."|||percentage of specificity|segments||Number
2687157|NCT01344447|Primary|Minimum Gadobutrol Performance for Sensitivity: Sensitivity > 50%|Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded as assessed by the SoR (CTA; blinded readers). For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. Gadobutrol minimum performance criteria was based on a stenosis of 50% calculated from the native vessel diameter.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category."|||percentage of sensitivity|segments||Number
2687158|NCT01344447|Primary|Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded, as assessed by the SoR (CTA; blinded readers). This was determined using the NASCET criteria. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. In case of multiple stenosis in any one segment, the most severe stenosis in the segment was recorded.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category of each group if it varies from Number of participants/segments analyzed."|||percentage of specificity|segments||Number
2687159|NCT01344447|Primary|Sensitivity for Detection of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Clinically significant disease was defined as 70 to 99% stenosis of a segment, but not occluded, as assessed by the standard of reference (SoR) (computed tomographic angiography [CTA]; blinded readers). This was determined using the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria. For each segment, the most severe stenosis/narrowing was identified and considered for the evaluation of clinically significant disease. In case of multiple stenosis in any one segment, the most severe stenosis in the segment was recorded.|Images were taken pre-injection and post-injection|"FAS; in below table, n/n signifies the number of participants/segments that were evaluable in specified category of each group."|||percentage of sensitivity|segments||Number
2687160|NCT01344447|Primary|Percentage of Assessable Vascular Segments Using Gadobutrol-Enhanced MRA and Unenhanced MRA|Each vascular segment was visualized using unenhanced MRA and gadobutrol-enhanced MRA, characterized by the on-site investigators, three independent blinded readers (BR) (BR 1, BR 2 and BR 3) and majority readers (the outcome determined by at least two of the blinded readers). A segment was assessable if it was visualized along its entire length and if any region of stenosis, was measured reliably. There were 21 segments of the supra-aortic arteries assessed per participant.|Images were taken pre-injection and post-injection|FAS|||percentage of segments|segments||Number
2687161|NCT01344369|Primary|AUC0-inf of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2687162|NCT01344369|Primary|AUC0-t of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.|||pg*h/mL||Standard Deviation|Mean
2687163|NCT01344369|Primary|Cmax of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.|||pg/mL||Standard Deviation|Mean
2687171|NCT01344226|Secondary|Flare Scores in Early Postoperative Period|Flare scores will be measured using a 1mmx1mm slit lamp beam. Flare was assessed by looking at a 1mmx1mm slit lamp beam into the anterior chamber. Three measurements were taken and the average flare score was reported. The final outcome measure was the final flare score at 42 days compared to baseline. The grading scale was 0-4 with 0 repesenting no flare, 1mild flare, 2 moderate flare, 3 moderate severe and 4 severe flare. Minmal values represent less inflammation and could represent better inflammatory control.|baseline to 6 weeks||||units on a scale||Standard Error|Mean
2687172|NCT01344226|Secondary|Cell Scores in the Early Outcome Period as Measured at 6 Weeks Post Phacoemulsification|Cell scores at the final visit (pod 42) will be compared with baseline cells and will be measured using 1mmx1mm slit lamp beam. White cells present in the anterior chamber in a 1mm x 1mm slit lamp beam measured 3 times with the average number of cells being recorded. The grading scale was 0 (no cells/high power field), 1 (1-5 cells/high power field), 2 (6-15 cells/high power field), 3 (16-25 cells/high power field) and 4 (>25 cells/high power field). Minimal values represent less inflammation or better inflammatory control and could represent a better outcome.|baseline to 6 weeks||||units on a scale||Standard Error|Mean
2687173|NCT01344226|Secondary|ETDRS Letters Read Over Early Postoperative Period|Final visual acuity at pod 42 as measured by ETDRS letters read was compared with baseline was measured for this outcome measure.|change in ETDRS letters read baseline to 6 weeks||||change in ETDRS letters read||Standard Error|Mean
2687174|NCT01344226|Primary|Investigate Clinical Outcomes for Intraocular Pressure After Treatment With Lotemax (Loteprednol Ophthalmic Solution) 0.5% QID in Subjects Who Have Undergone Cataract Extraction With Posterior Chamber Intraocular Implantation.|Evaluate intraocular pressure change in mm Hg from baseline in the first 6 weeks following cataract surgery in individuals treated with Lotemax (loteprednol ophthalmic solution) 0.5% QID after cataract extraction with posterior chamber intraocular implantation.|baseline to 6 weeks||||mm Hg||Standard Error|Mean
2687175|NCT01344161|Primary|Change in Insulin Concentrations||3 months minus baseline||||pmol/L||Standard Deviation|Mean
2687176|NCT01344161|Primary|Change in Post Load Glucose Concentrations|It was performed 2 hours after 75g oral glucose tolerance test (75-OGTT).|3 months minus baseline||||mmol/L||Standard Deviation|Mean
2687177|NCT01344161|Primary|Change in Glucose Concentrations||3 months minus baseline||||mmol/L||Standard Deviation|Mean
2687178|NCT01344161|Primary|Change in Body Fat Mass|Body composition was assessed by Bioelectrical Impedance Analysis (model 4000; Body Stat Quad Scan, Douglas Isle of Man, British Isles).The principle of measuring the flow of current through the body is dependent on the frequency applied. At low frequencies, the current cannot bridge the cellular membrane and will pass predominantly through the extra-cellular space. At higher frequencies penetration of the cell membrane occurs and the current is conducted by both the extra-cellular water (ECW) and intra-cellular water (ICW).FFM can be estimated because FFM is primarily composed of water.|3 months minus baseline|We assessed body composition by Bioelectrical Impedance Analysis (model 4000; Body Stat Quad Scan, Douglas Isle of Man, British Isles).|||kg||Standard Deviation|Mean
2687179|NCT01344057|Primary|Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 1) and three weeks after FLUAD vaccination (day 22).~This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years)."|day 22|Analysis was done using PP set.|||Percentage of participants||95% Confidence Interval|Number
2687180|NCT01344057|Primary|Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD|"Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 22).~The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.0 (≥65 years)."|day 22|Analysis was done using PP set.|||Ratio||95% Confidence Interval|Geometric Mean
2687181|NCT01344057|Secondary|Number of Participants Who Reported Solicited Local and Systemic Reactions|Safety was assessed for participants who reported solicited local and systemic reactions from day 1 up to and including day 4 after the FLUAD vaccination.|1 to 4 days post-vaccination|Analysis was done using the safety dataset; participants who received study vaccination and who provided post-vaccination safety data.|||Number of participants|||Number
2687182|NCT01344057|Primary|Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD|"Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay.~Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase.~The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years)."|day 22|Per protocol (PP) analysis set included all enrolled participants who had correctly received the vaccine, provided evaluable serum samples before and after vaccination, and had no major protocol violations.|||Percentage of participants||95% Confidence Interval|Number
2687183|NCT01343901|Secondary|Percentage of Participants With Unresectability Criteria||Day 0|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.|||Percentage of participants|||Number
2687184|NCT01343901|Secondary|Total Duration of First Line Bevacizumab Treatment at Day 0||Day 0|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.|||months||Full Range|Median
2687185|NCT01343901|Secondary|Percentage of Participants With Different Doses of First Line Bevacizumab at Day 0||Day 0|Efficacy population. Here, number of participants analyzed represents the number of participants evaluable for this outcome measure.|||Percentage of participants|||Number
2707236|NCT01192282|Primary|Commonest HPV Genotypes Isolated by HIV Status|10 commonest types of HPV isolated according to HIV status|18 months||||Participants|||Number
2687187|NCT01343901|Secondary|Percentage of Participants With Histologically Viable Tumor Cells With Resected Non Detectable Hepatic and Pulmonary Metastases Post Surgery|For the non-detectable liver and lung metastases the categorization based on rate of viable cells were as follows (no viable cells =0%, minimum =1 to 49%, maximum =50 to 100%).|Baseline up to 36 months|Efficacy population. Here number of participants analyzed represents the overall number of participants evaluable for this outcome and ‘n’ represents the number of participants available for assessment at a given category.|||Percentage of participants|||Number
2687188|NCT01343901|Secondary|Overall Survival (OS)|OS time is defined as time between start of therapy and date of death. Kaplan-Meier estimate was used for evaluation.|Baseline until death, assessed up to 36 months|Efficacy population|||months||95% Confidence Interval|Median
2687189|NCT01343901|Secondary|Percentage of Participants Who Died||Baseline until death; assessed up to 36 months|Efficacy population|||Percentage of participants|||Number
2687190|NCT01343901|Secondary|Relapse-free Survival (RFS)|RFS was defined as the time elapsed between the last surgery removing all detectable metastases (A1 criterion [participants without DMD after secondary resection removing all detectable metastases at surgery {including participants with missing metastases}]) and the date of first PD or death. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions, or appearance of one or more new lesions.|Baseline until disease progression or death, whichever occurred first, assessed up to 36 months|Efficacy population. Here number of participants analyzed signifies efficacy population with surgery removing all the detectable metastases.|||Months||95% Confidence Interval|Median
2687191|NCT01343901|Secondary|Percentage of Participants With Disease Relapse|Relapse was defined as the presence of metastases post last surgery removing all detectable metastases (A1 criterion [participants without detectable metastatic disease {DMD} after secondary resection removing all detectable metastases at surgery {including participants with missing metastases}]) and the date of first PD or death. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions, or appearance of one or more new lesions.|Baseline until disease progression or death, whichever occurred first, assessed up to 36 months|Efficacy population. Here number of participants analyzed signifies efficacy population with surgery removing all the detectable metastases.|||Percentage of participants|||Number
2687192|NCT01343901|Secondary|Progression-free Survival (PFS)|Progression-free survival defined as the time elapsed between the Avastin start date and the date of first progressive disease (PD) or death. Kaplan-Meier estimate was used for evaluation. PD: At least a 20% increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 mm or persistence of non-target lesions or appearance of one or more new lesions.|Baseline until disease progression or death, whichever occurred first, assessed up to 36 months|Efficacy population.|||Months||95% Confidence Interval|Median
2687193|NCT01343901|Secondary|Percentage of Participants With Disease Progression or Death|Disease progression is defined at least a 20 percent (%) increase in the sum of diameters of target lesions, and the sum must also demonstrate an absolute increase of at least 5 millimeter (mm) or persistence of non-target lesions, or appearance of one or more new lesions.|Baseline until disease progression or death, whichever occurred first, assessed up to 36 months|Efficacy population|||Percentage of participants|||Number
2687194|NCT01343901|Secondary|Percentage of Participants With at Least One Comorbidity Post Bevacizumab Treatment|Percentage of participants who had any concurrent disease (comorbidity) was reported. Comorbidities included gastrointestinal disease, other cardiovascular disease, and other medical history and comorbidities (other than those which are specified above). Same participant may be counted in more than one category.|Baseline up to 36 months|Analysis population consisted of participants with disappeared metastasis left in place with or without surgery. Here number of participants analyzed represents the number of participants evaluable for this outcome and ‘n’ represents the number of participants available for assessment at a given category.|||Percentage of participants|||Number
2687195|NCT01343901|Secondary|Percentage of Participants Who Received at Least One Chemotherapy Over the Study Period||Baseline up to 36 months|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.|||Percentage of participants|||Number
2687196|NCT01343901|Secondary|Mean Number of Cumulated Cycles of Bevacizumab Over the Study Period||Baseline up to 36 months|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.|||Cycles||Standard Deviation|Mean
2687197|NCT01343901|Secondary|Percentage of Participants With Different Previous Therapies at Day 0|Previous therapies included neoadjuvant treatment (chemotherapy or chemotherapy + radiotherapy) and adjuvant treatment (FOLFOX [folinic acid+5-fluorouracil+oxaliplatin], LV5FU2 [leucovorin+5-Fluorouracil], capecitabine, or any other adjuvant treatment). Only participants who received neoadjuvant treatment and adjuvant treatment was reported.|Day 0|Efficacy population. Here number of participants analysed represents the number of participants evaluable for this outcome measure.|||Percentage of participants|||Number
2687198|NCT01343901|Secondary|Percentage of Participants With at Least One Disease and Comorbidity at Day 0|Percentage of participants who had any concurrent disease (comorbidity) at Day 0 was reported. Comorbidities included gastrointestinal disease, hypertension, other cardiovascular disease, and other medical history and comorbidities (other than those specified above). Same participant may be counted in more than one category.|Day 0|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome and ‘n’ represents the number of participants available for assessment at a given category.|||Percentage of participants|||Number
2687199|NCT01343901|Primary|Percentage of Participants Without Detectable Metastatic Disease After a Complete Response Without Surgery|The percentage of participants with no detectable metastatic disease after a complete response without surgery (missing metastasis) was reported.|Baseline up to 36 months|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.|||Percentage of participants|||Number
2687258|NCT01343056|Secondary|Systolic Blood Pressure|Systolic blood pressure is the pressure when the heart beats while pumping blood.|6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.|||mmHg||Full Range|Median
2687200|NCT01343901|Primary|Percentage of Participants Without Detectable Metastatic Disease After Secondary Resection Post Surgery|Secondary resection involves removal of all detectable metastases at surgery including participants with missing metastases left in place. Percentage of participants without detectable metastatic disease after secondary resection removing all detectable metastases at surgery (including participants with disappeared metastases left in place [missing metastases]) was reported. Metastases was detected using computed tomography (CT) scan or magnetic resonance imaging (MRI).|Baseline up to 36 months|Efficacy population. Here number of participants analyzed represents the number of participants evaluable for this outcome measure.|||Percentage of participants|||Number
2687201|NCT01343888|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO|This will be presented as the number of patients. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
2687202|NCT01343888|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES|This will be presented as the number of patients. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
2687203|NCT01343888|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
2687204|NCT01343888|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT) When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
2687205|NCT01343888|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO|This will be presented as the number of patients. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
2687206|NCT01343888|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES|This will be presented as the number of patients. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
2687207|NCT01343888|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12= NO|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
2687208|NCT01343888|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT) When SVR12=YES|This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||participants|||Number
2687209|NCT01343888|Secondary|Early Treatment Success (ETS)|Early treatment success (ETS), defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.|week 4 and week 8|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||percentage of participants|||Number
2687210|NCT01343888|Secondary|Sustained Virological Response 24 Weeks Post-treatment (SVR24)|Sustained Virological Response 24 weeks post-treatment (SVR24), defined as plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.|24 weeks post treatment, up to 72 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2687211|NCT01343888|Primary|Sustained Virological Response 12 Weeks Post-treatment (SVR12)|Sustained Virological Response 12 weeks post-treatment (SVR12), defined as plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level < 25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.|12 weeks post treatment, up to 60 weeks|Full analysis set (FAS) included all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication.|||percentage of participants||95% Confidence Interval|Number
2687212|NCT01343823|Secondary|Time to Symptom Resolution Based on the Visual Analog Scale (VAS)|"Compare the time to onset of symptom resolution between the ecallantide-treated and placebo-treated groups.~The patient assessed severity of the angioedema attack using a VAS at baseline and following study drug administration every 15 minutes for the first 2 hours and then every 30 minutes through 6 hours post dosing or until the time of discharge from the ER (whichever occurred first). The scale ranged from totally resolved to very severe."|6 hours|Time to Symptom Resolution Based on the VAS (Safety Population)|||hours||95% Confidence Interval|Median
2687240|NCT01343277|Primary|Overall Survival (OS)|The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.|approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015]|Analysis population included all the randomized participants up to up to final analysis cut-off date (05 January 2015).|||Months||95% Confidence Interval|Median
2687213|NCT01343823|Primary|Safety and Efficacy of Ecallantide|"Compare the proportion of patients meeting prespecified discharge criteria in the group receiving ecallantide with conventional therapy to patients receiving placebo with conventional therapy.~Patients were evaluated against 6 discharge eligibility criteria at 1,2,3,4,5, and 6 hours after study drug administration or until discharged from the ER.~A responder was defined as a patient meeting all six discharge eligibility criteria as below:~Improvement of edema to a little better or a lot better as assessed by health care provider using a five point scale~Stable vital signs (within an acceptable range)~Absence of stridor~Absence of dyspnea or use of accessory muscles during respiration~Absence of drooling~Able to drink without difficulty"|6 hours|Safety Population|||participants||95% Confidence Interval|Number
2687214|NCT01343693|Secondary|Change in Neck Disability Index (NDI)|The Neck Disability Index (NDI) is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain', with the points summed to a total score. The test can be interpretated as a raw score, with a minimum score of 0 and a maximum score of 50. A higher score indicates more patient-rated disability. To use the NDI for patient decisions, a clinically important change was calculated as 5 points.|24 Months||||score on a scale||Standard Deviation|Mean
2687215|NCT01343693|Primary|Number of Participants With Differing Severity of Adjacent Level Ossification|Qualitatively assessed by an independent Radiologist using lateral radiographs Grade 0 - None Grade 1 - Mild (if the ossification extended across <50% of the disc space) Grade 2 - Moderate (if the ossification extended across ≥ 50% of the disc space) Grade 3 - Severe (if there is complete bridging of the adjacent disc space)|24 Months|Ten of the 110 patients with 24 month follow up were not evaluated for this endpoint. Eight had missing radiographs and 2 had unevaluable radiographs.|||Participants|||Count of Participants
2687216|NCT01343667|Primary|Major Adverse Events (MAE)|Major Adverse Events include death, stroke and myocardial infarction|Onset from start of index procedure to 30-day follow-up assessment|Enrolled subjects with successful procedure and sufficient follow-up|||participants|||Number
2687217|NCT01343485|Primary|On-time Completion of the Human Papillomavirus Vaccine Series||32 weeks after receipt of initial vaccine||||participants|||Number
2687218|NCT01343407|Other Pre-specified|Baseline Expression of Cluster of Differentiation (CD)11b on Blood Eosinophils|Baseline values for the antibody-specific expression of CD11b in whole blood samples, as obtained by flow cytometry, were obtained. The baseline CD11b values were obtained before treatment with MK-1029 60 mg, MK-1029 500 mg, or placebo, and were used to assess the effects of treatment.|Day 1, predose|Participants who were compliant with the protocol sufficiently to ensure their data would be likely to exhibit the effects of treatment were included.|||Antibody fluorescence units||Standard Deviation|Mean
2687219|NCT01343407|Other Pre-specified|Baseline (Pre-Treatment) Percent (%) Eosinophils|Baseline values of the percent (%) sputum eosinophils were measured pre-antigen challenge on Day -1. The baseline % eosinophil values were provided to assess the change from baseline after treatment.|Baseline (Day -1), pre-antigen challenge|Participants who were compliant with the protocol sufficiently to ensure their data would be likely to exhibit the effects of treatment were included.|||% sputum eosinophils||Full Range|Mean
2687220|NCT01343407|Primary|Number of Participants Discontinuing Treatment Due to an AE|The number of participants who discontinued study treatment due to an AE was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.|Up to 5 days in each treatment period|All randomized participants who received at least one dose of study treatment.|||Participants|||Count of Participants
2687221|NCT01343407|Primary|Number of Participants With an Adverse Event (AE)|The number of participants who had at least one adverse event (AE) during study treatment and follow-up was assessed. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product.|Up to 26 days in each treatment period|All randomized participants who received at least one dose of study treatment and had follow-up.|||Participants|||Count of Participants
2687222|NCT01343407|Secondary|Percent Inhibition of the Expression of Cluster of Differentiation (CD)11b on Blood Eosinophils|The concentration of CD11b in whole blood samples was assessed. The percent-inhibition of CD11b (a cell-surface biomarker on activated eosinophils) was assessed following inhaled allergen challenge on Day 5. Inhibition of CD11b expression was assessed by analyzing the % inhibition of CD11b expression from baseline (Day -1) using a linear mixed-effects model with period, treatment, time, and treatment by time as fixed terms and subject as a random term. Outcome Measure 7 shows CD11b expression values at baseline.|Baseline (Day -1, predose), 24 hours after allergen challenge on Day 5 in each treatment period|Participants who comply with the protocol sufficiently to ensure data obtained will be likely to exhibit the effects of treatment, according to the underlying scientific model.|||Percentage of inhibition||95% Confidence Interval|Least Squares Mean
2687223|NCT01343407|Primary|Forced Expiratory Volume in One Second (FEV1) From 3 to 8 Hours Postdose (AUC3-8hr) During the Late Asthmatic Response (LAR)|The effect of MK-1029 on the FEV1 AUC(3-8hr) during LAR was assessed. The unit of measure for an FEV1 AUC value is L*hr. The effect of treatment on LAR was assessed as the percent-fall in FEV1 AUC(3-8hr), evaluated by spirometry following allergen challenge on Day 5. The FEV1 AUC(3-8hr) during LAR was analyzed using a linear mixed effects model with treatment and period as fixed factors and participant as a random factor.|From 3 to 8 hours after allergen challenge on Day 5 of each treatment period|Participants who comply with the protocol sufficiently to ensure data obtained will be likely to exhibit the effects of treatment, according to the underlying scientific model.|||L*hr||95% Confidence Interval|Least Squares Mean
2687241|NCT01343277|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015])|Safety population included all the treated participants.|||Participants|||Number
2687224|NCT01343407|Primary|Percent Change From Baseline in Percent (%) Eosinophils in Induced Sputum At 8 Hours Post Allergen|The effect of MK-1029 on the reduction of percent (%) sputum eosinophils following allergen challenge with standardized cat pelt or hair (CPH) allergen extract was assessed. Baseline % eosinophils were measured before treatment (and pre-allergen challenge) on Day -1. The change from baseline in allergen-induced % sputum eosinophils at 8 hr post allergen challenge testing on Day 5 was analyzed using a repeated measures linear mixed effects model with treatment, period, time, time-by-treatment interaction as fixed factors, and participant as a random factor. Outcome Measure 6 shows % eosinophil values at baseline.|Baseline (Day -1) and Day 5 (8 hours after allergen challenge in each treatment period)|Participants who comply with the protocol sufficiently to ensure data obtained will be likely to exhibit the effects of treatment, according to the underlying scientific model.|||Percent change||95% Confidence Interval|Least Squares Mean
2687225|NCT01343368|Secondary|Comparison of Antimullerian Hormone (AMH) Levels After Transplant|Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.|Day 180 after Transplant|Four patients on the Observational and 10 patients on the Observational arm never had any follow-up AMH levels drawn and were removed from this analysis.|||ng/ml||Standard Deviation|Mean
2687226|NCT01343368|Secondary|Comparison of Antimullerian Hormone (AMH) Levels After Transplant|Comparison of treatment arms; interventional versus observational average AMH levels after receiving transplant.|Day Prior to Transplant|Six patients on the Observational arm never had any follow-up AMH levels drawn and were removed from this analysis.|||ng/ml||Standard Deviation|Mean
2687227|NCT01343368|Secondary|Comparison of Leuprolide Hormone (LH) Levels|Comparison of treatment arms; interventional versus observational average LH levels during study.|2 years|Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. All 7 patients on the Interventional arm and 8 patients on the Observational arm were lost to follow-up.|||IU/L||Standard Deviation|Mean
2687228|NCT01343368|Secondary|Comparison of Luteinizing Hormone (LH) Levels|Comparison of treatment arms; interventional versus observational average LH levels during study.|1 year|Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis. Three patients on the Interventional arm and 8 patients on the Observational arm were lost to follow-up.|||IU/L||Standard Deviation|Mean
2687229|NCT01343368|Secondary|Comparison of Luteinizing Hormone (LH) Levels|Comparison of treatment arms; interventional versus observational average LH levels during study.|Day 180|Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis. One patient on the Interventional arm and 7 on the Observational arm were lost to follow-up.|||IU/L||Standard Deviation|Mean
2687230|NCT01343368|Secondary|Comparison of Luteinizing Hormone (LH) Levels|Comparison of treatment arms; interventional versus observational average LH levels during study.|Day 100|Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis. One patient on the Interventional arm and 7 on the Observational arm were lost to follow-up.|||IU/L||Standard Deviation|Mean
2687231|NCT01343368|Secondary|Comparison of Lutineizing Hormone (LH) Levels|Comparison of treatment arms; interventional versus observational average LH levels during study.|Baseline|Four patients on the Observational arm never had any follow-up LH levels drawn and were removed from this analysis.|||IU/L||Standard Deviation|Mean
2687232|NCT01343368|Secondary|Comparison of Number of Patients Who Resumed Menstrual Cycles|Comparison of treatment arms; interventional versus observational. Count of patients who resumed menses after hematopoietic cell transplant|Day 365 Post Transplant|Only 6 of the 10 patients that started on the Observational Arm were evaluable. The 2 patients were lost to follow-up.|||Participants|||Count of Participants
2687233|NCT01343368|Secondary|Comparison of Follicle Stimulating Hormone (FSH) Levels|Comparison of treatment arms; interventional versus observational average FSH levels.|2 years|Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. All 7 patients on the Interventional arm and 8 patients on the Observational arm were lost to follow-up.|||IU/L||Standard Deviation|Mean
2687234|NCT01343368|Secondary|Comparison of Follicle Stimulating Hormone (FSH) Levels|Comparison of treatment arms; interventional versus observational average FSH levels.|1 year|Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. Three patients on the Interventional arm and 8 patients on the Observational arm were lost to follow-up.|||IU/L||Standard Deviation|Mean
2687235|NCT01343368|Secondary|Comparison of Follicle Stimulating Hormone (FSH) Levels|Comparison of treatment arms; interventional versus observational average FSH levels.|Day 180|Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. One patient on the Interventional arm and 7 on the Observational arm were lost to follow-up.|||IU/L||Standard Deviation|Mean
2687236|NCT01343368|Secondary|Comparison of Follicle Stimulating Hormone (FSH) Levels|Comparison of treatment arms; interventional versus observational average FSH levels.|Day 100|Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis. One patient on the Interventional arm and 7 on the Observational arm were lost to follow-up.|||IU/L||Standard Deviation|Mean
2687237|NCT01343368|Secondary|Comparison of Follicle Stimulating Hormone (FSH) Levels|Comparison of treatment arms; interventional versus observational average FSH levels.|Baseline|Four patients on the Observational arm never had any follow-up FSH levels drawn and were removed from this analysis.|||IU/L||Standard Deviation|Mean
2687238|NCT01343368|Secondary|Comparison of Number of Patients Who Stopped Menstrual Bleeding|Comparison of treatment arms; interventional versus observational. Count of patients who stopped menstrual bleeding; to determine how the effect of GnRH agonists are at suppressing menses during hematopoietic cell transplant|From Baseline Through Day 365|Five patients on the Interventional arm and 10 patients on the Observational arm were lost to follow-up by Day 365.|||Participants|||Count of Participants
2687239|NCT01343368|Primary|Comparison of Number of Patients With Ovarian Failure|Comparison of treatment arms; interventional versus observational. Ovarian failure rate is based on FSH measured at 180 days after HCT; to determine the effect of GnRH agonists on the incidence of ovarian failure (i.e. FSH >40 IU/L) after transplant.|Through Day 180 Post Transplant||||Participants|||Count of Participants
2687257|NCT01343082|Primary|Change From Baseline in IOP (Intraocular Pressure) at End of Study||Treatment period: Week 0 (Baseline) and Week 52 (End of Study)||||mmHg||Standard Deviation|Mean
2687242|NCT01343277|Secondary|Duration of Response|"Duration of response is defined as the time from the date of initial documentation of a response (CR or PR) to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death.~Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed."|approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])|"Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure."|||Months||95% Confidence Interval|Median
2687243|NCT01343277|Secondary|Objective Response Rate|The objective response rate (ORR) is defined as the percentage of participants who achieved a Complete response (CR) or partial response (PR) as best responses. according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST). CR defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters. Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.|approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])|"Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure."|||Percentage of Participants||95% Confidence Interval|Number
2687244|NCT01343277|Secondary|Time to Progression|"Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.~Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed."|approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])|"Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure."|||Months||95% Confidence Interval|Median
2687245|NCT01343277|Secondary|Progression-Free Survival (PFS)|The Progression-Free Survival (PFS) was assessed as median number of months from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier. Independent Data Monitoring Committee performed ongoing safety monitoring and conducted the interim analysis after 189 death events and 329 PFS events were observed.|approximately 2 years 4 months (From Study start date [27 May 2011] up to interim analysis data cut-off [16 September 2013])|"Analysis population included all the randomized participants up to interim analysis cut-off date (16 September 2013). N (number of participants analyzed) signifies the participants evaluable for this measure."|||Months||95% Confidence Interval|Median
2687246|NCT01343251|Secondary|Hospitalization Rate (Percentage of Participants Who Were Hospitalized at Least Once While on Study)|Compare incidence of hospitalization (for any reason) between study arms. Reasons for hospitalizations included: infection, cardiac problems, bleeding, vascular access thrombosis, fall (injury), hematuria, fluid overload, peripheral neuropathy, pulmonary embolism, edema, and shortness of breath.|1 year||||Percentage of patients|||Number
2687247|NCT01343251|Secondary|Intervention Rate (Percentage of Participants Who Required at Least One Intervention While on Study)|Compare vascular intervention rates between study arms. The vascular interventions which were included were: Angioplasty, Thrombectomy, Arteriovenous (AV) Fistulogram/Diagnostic Angiogram, Banding, Access Removal, Access Exchange, Access Revision, Creation of New Access, and any combination of these interventions which were performed simultaneously.|1 year||||percentage of participants|||Number
2687248|NCT01343251|Secondary|Quality of Life|Compare the RAND Short Form (SF)-36 Health Survey, Total Test Scores at baseline, 3, 6, and 12 months between study arms. Total test scores range on a scale from 0-100, with the lower the score equating to more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. The total score is calculated using a methodology described by the RAND Corporation, which assigns a recoded value to each survey item. Recoded items are averaged amongst scales and the total score is an average of the eight sections. (http://www.rand.org/content/dam/rand/www/external/health/surveys_tools/mos/mos_core_36item_scoring.pdf).|1 year|The number of completed tests varied by time point and study group. The number of completed tests for Test 1, Test 2, Test 3, and Test 4 was 14, 13, 10, and 8 for the HeRO Graft group and 17, 13, 7, and 4 for the Control group, respectively. Only completed tests were included in the analysis.|||units on a scale||Standard Deviation|Mean
2687249|NCT01343251|Secondary|Infection Rate (Percentage of Participants With at Least One Infection)|Compare incidence of infection between study arms|1 year||||Percentage of Patients|||Number
2687250|NCT01343251|Primary|Mortality|Compare mortality rate between study arms|1 year||||percentage of participants who died|||Number
2687251|NCT01343095|Secondary|Amount of Sedative Use (Propofol and Demedetomidine )|Mean of sedative daily use (Propofol and Demedetomidine )|During the Study Period (Study Days 0-7)||||mcg/kg||Full Range|Mean
2687252|NCT01343095|Secondary|Amount of Analgesic Use|Mean of analgesic daily use|During the Study Period (Study Days 0-7)||||mg||Full Range|Mean
2687253|NCT01343095|Secondary|Amount of Sedative Use (Midazolam and Lorazepam)||During the Study Period (Study Days 0-7)||||mg||Full Range|Mean
2687254|NCT01343095|Secondary|Sleep Efficiency and Architecture|Staging of sleep with efficiency determined as a ratio of total sleep time/total study time.|Overnight (10pm-6am) on study day 2 or 3|Sleep measurement equipment was not available for use during the study period||||||
2687255|NCT01343095|Secondary|Noise Attenuation|The reduction in noise experienced by the subject when using the study intervention.|Overnight (10pm-6am) on study day 2 or 3.|Devices were unable to measure noise above 85 dB(A) from the in-ear location; no noise data was collected.||||||
2687256|NCT01343095|Primary|Days Free of Delirium or Coma||During the Study Period (Study Days 0-7 while patients were in ICU)||||days||Full Range|Mean
2687259|NCT01343056|Secondary|Diastolic Blood Pressure|Diastolic blood pressure is the pressure when the heart is at rest between beats.|6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.|||mmHg||Full Range|Median
2687260|NCT01343056|Secondary|Body Mass Index|Body Mass Index is a weight-to-height ratio, calculated by dividing one's weight in kilograms by the square of one's height in meters and used as an indicator of obesity and underweight.|6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.|||kg/m^2||Full Range|Median
2687261|NCT01343056|Secondary|Change in Diabetes Empowerment Scale- Short Form (DES-SF) Scores|"The DES-SF is a validated, 8 item scale that measures the self-efficacy of patients with diabetes. Responses are selected from a 5-point Likert scale (Strongly Disagree (1), Somewhat Disagree (2), Neutral (3), Somewhat Agree (4), Strongly Agree (5)). The scale is scored by averaging the scores of all completed items (sum of scores divided by 8).~A positive number represents an improvement in overall patient self-efficacy (empowerment) from the baseline score and 6 month follow up time point."|6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.|||units on a scale||Standard Deviation|Mean
2687262|NCT01343056|Secondary|Low Density Lipoprotein (LDL, mg/dL)||6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.|||mg/dL||Full Range|Median
2687263|NCT01343056|Secondary|High Density Lipoprotein (HDL, mg/dL)||6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.|||mg/dL||Full Range|Median
2687264|NCT01343056|Secondary|Total Cholesterol (mg/dL)||6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.|||mg/dL||Full Range|Median
2687265|NCT01343056|Primary|Hemoglobin A1C (HbA1C, %)||6 months|Number of participants analyzed represents the number of participants who completed a 6 month follow up visit and, therefore, differs from numbers reported in the Participant Flow Module.|||percentage of glycosolated hemoglobin||Full Range|Median
2687266|NCT01343004|Secondary|Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months||18 months|Safety population included all patients who received 1 or more doses of study medication|||Hypercalcemic events|||Number
2687267|NCT01343004|Secondary|Number of Participants With Non-vertebral Fractures at 18 Months||18 months|Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1.|||Participants|||Number
2687268|NCT01343004|Secondary|Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18||Baseline and 18 months|Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1. Baseline BMD data were missing for some patients; the method of last observation carried forward (LOCF) was used to impute missing data.|||percent change||Standard Deviation|Mean
2687269|NCT01343004|Secondary|Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18||Baseline and 18 months|Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1. Baseline BMD data were missing for some patients; the method of last observation carried forward (LOCF) was used to impute missing data.|||percent change||Standard Deviation|Mean
2687270|NCT01343004|Secondary|Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months||Basline and 18 months|Intent-to-treat population included all patients who were randomized into the study by assigning the randomized study medication kit on Day 1. Baseline BMD data were missing for some patients; the method of last observation carried forward (LOCF) was used to impute missing data.|||percent change from baseline||Standard Deviation|Mean
2687271|NCT01343004|Primary|Number of Participants With New Vertebral Fractures at 18 Months||18 months|Modified intent-to-treat (MITT) population included all patients with pre-treatment and end-of-treatment evaluable radiologic assessment (spine X-ray).|||participants|||Number
2687272|NCT01342965|Secondary|Quality of Life: Functional Assessment of Chronic Illness Therapy - Lung (FACIT-L) Questionnaire||approximately 21 months|||||||
2687273|NCT01342965|Secondary|Safety: Incidence of Adverse Events||36 months|||||||
2687274|NCT01342965|Secondary|Overall Survival|Overall survival was defined as the time from the date of randomization to the date of death from any cause.|Baseline to the end of the study (3 years, 1 month)|Full analysis set: All randomized participants.|||Months||95% Confidence Interval|Median
2687275|NCT01342965|Secondary|Duration of Response|Duration of response was defined as the time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression (PD) or death, whichever occurs first. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs taking as reference the Baseline SLD. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs.|Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)|Full analysis set: All randomized participants. Only participants who had a complete response or partial response were included in the analysis.|||Months||95% Confidence Interval|Median
2687286|NCT01342926|Secondary|Number of Participants Losing Letters in Early Treatment Diabetic Retinopathy Study (ETDRS)-Best Corrected Visual Acuity (BCVA) Score at Month 12 and Month 18 for Each Eye|Participants enrolled into the study were required to have a best-corrected ETDRS visual acuity score of at least 35 letters as determined by ETDRS-BCVA evaluation. ETDRS-BCVA score was assessed at the indiated time points at: Month 12 and Month 18 with categorical changes in the number of participants losing >30, >=15, >=10, >=5 and <5 letters.|Month 12 and Month 18|ITT Population|||Participants|||Number
2687520|NCT01340872|Secondary|Change in Haemoglobin Concentration From Baseline to Week 48 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 48 (FAS), after 12-week double-blind phase and then 36 weeks of open-label ST10 treatment|Baseline to Week 48 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
2687276|NCT01342965|Secondary|Percentage of Participants With Disease Control|A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD.|Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)|Full analysis set: All randomized participants.|||Percentage of participants|||Number
2687277|NCT01342965|Secondary|Percentage of Responders as Assessed by the Investigator|A responder was defined as a participant with either a complete response (CR) or a partial response (PR), as determined using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. A CR was defined as: (1) The disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to < 10 mm. (2) The disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be non-pathological in size (< 10 mm in the short axis). A PR was defined as: (1) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. (2) The persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker levels above normal limits.|Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)|Full analysis set: All randomized participants.|||Percentage of responders|||Number
2687278|NCT01342965|Primary|Investigator-assessed Duration of Progression-free Survival|The duration of progression-free survival was defined as the time from randomization to disease progression (PD) or death from any cause, whichever occurs first. PD was defined as: (1) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. (2) An unequivocal progression of existing non-target lesions. When the patient has measurable disease, the overall tumor burden must have increased sufficiently to merit discontinuation of therapy. When the patient has only non-measurable disease, the increase in overall disease burden should be comparable in magnitude to the increase that would be required to declare PD for measurable disease. (3) The appearance of new malignant lesions.|Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months)|Full analysis set: All randomized participants.|||Months||95% Confidence Interval|Median
2687279|NCT01342926|Secondary|The Pharmacodynamic Effects of GSK933776 Total (Bound and Unbound) Plasma Total Amyloid Beta (Abeta42), and Amyloid Beta Fragments (Abeta18-35), if Possible, Unbound Plasma Aβ Fragments (Abeta1-22)|Blood samples were collected at the indicated time points on Baseline, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15 and Month 18. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15 and Month 18|PD Concentration Population: all participants in the ITT Population with at least one PD sample|||picogram (PG)/ML||Standard Deviation|Mean
2687280|NCT01342926|Secondary|Volume of Distribution at Steady-state (Vdss) of GSK933776 in Geographic Atrophy Participants Estimated From Population PK Modeling|Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476.|Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476|PK Parameter Population|||mL||95% Confidence Interval|Geometric Mean
2687281|NCT01342926|Secondary|Estimation of Terminal Phase Half-life (T1/2) of GSK933776 in Geographic Atrophy Participants|Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476.|Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476|PK Parameter Population|||Days||95% Confidence Interval|Geometric Mean
2687282|NCT01342926|Secondary|Clearance (CL) of GSK933776 in Geographic Atrophy Participants|Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476.|Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476|PK Parameter Population|||mL/h||95% Confidence Interval|Geometric Mean
2687283|NCT01342926|Secondary|Maximum Observed Plasma Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) of GSK933776 in Geographic Atrophy Participants|Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476|Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476|PK Parameter Population|||nanogram (ng)/mL||95% Confidence Interval|Geometric Mean
2687284|NCT01342926|Secondary|Area Under the Plasma Concentration-time Curve From Time 0 to the End of Dosing Interval at Steady-state (AUC0-28d) of GSK933776 in Geographic Atrophy Participants|Area under the plasma concentration-time curve from time 0 to the end of dosing interval at steady-state; derived from dose and clearance parameters was evaluated. Blood samples were collected at the indicated time points on Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476.|Day 56, Day 63, 70 or 77, Day 84, Day 112, Day 140, Day 224, Day 308, Day 392 and Day 476|Pharmacokinetic (PK) Parameter Population: all participants in the ITT Population with derived PK parameters|||microgram (mcg)*hours (h)/mL||95% Confidence Interval|Geometric Mean
2687285|NCT01342926|Secondary|Mean Change in ETDRS-BCVA Score From Baseline at Every Month up to Month 18|Participants enrolled into the study were required to have a best-corrected ETDRS visual acuity score of at least 35 letters as determined by ETDRS-BCVA evaluation. ETDRS-BCVA score was assessed as change from baseline in the mean best-corrected ETDRS visual acuity score at 18 months. Change from Baseline is defined as post-dose visit value minus Baseline value. Note that screening occurs before baseline. Values were truncated to one decimal place and negative sign retained where value is negative and the truncated value is zero. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline and every month up to Month 18|ITT Population|||Scores on a scale||Standard Deviation|Mean
2697166|NCT01263717|Secondary|Insulin Like Growth Factor 1 (IGF-I)|Insulin Like Growth Factor 1 (IGF-I).|6 months|All available data were used; data were not available for one subject.|||Change in ng/mL||Standard Deviation|Mean
2687287|NCT01342926|Secondary|Change From Baseline in Area of Total hypoAF in Study Eye|Atrophic AMD also called as GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by fundus autofluorescence at the indicated time points: screening, 6 months, 12 months and at 18 months. Change from Baseline: (Month 6, 12, 18 value minus Baseline value, respectively. Note screening occurs before baseline). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, 6 months, 12 months and 18 months|Efficacy Population|||mm^2||90% Confidence Interval|Mean
2687288|NCT01342926|Secondary|Change From Baseline in Area of GA Assessed by Fundus Autofluorescence Images (hypoAF) Corresponding to GA in Study Eye|Atrophic AMD also called as GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by fundus autofluorescence images in the study eye at the indicated time points: screening, 6 months, 12 months and at 18 months. Change from Baseline: (months 6, 12,18 value minus Baseline value, respectively. Note screening occurs before baseline). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, 6 months, 12 months and 18 months|Efficacy Population|||mm^2||90% Confidence Interval|Mean
2687289|NCT01342926|Primary|Number of Participants With Abnormal Magnetic Resonance Imaging (MRI)|Magnetic Resonance Imaging (MRI) was used as a safety assessment to monitor for amyloid related imaging abnormalities (ARIA) events in the brain. MRIs were performed at Baseline and before dose 2, before dose 3, before dose 4, before dose 6, before dose 12, before dose 18 and at follow-up. ARIA-edema/effusions (ARIA-E) and ARIA hemosiderin deposition (ARIA-H) events at any visit are reported.|Month 2, Month 3, Month 4, Month 6, Month 12, Month 18 and at early withdrawal|ITT Population|||Participants|||Number
2687290|NCT01342926|Primary|Number of Participants With Abnormal Laboratory Parameter Values of Potential Clinical Importance (PCI)|The following laboratory parameters were assessed: Hematology: Platelet Count, Red Blood Cell Count, White Blood Cell (WBC) Count, Reticulocyte Count, Hemoglobin, Hematocrit, Prothrombin time-International Normalized Ratio, Activated partial thromboplastin time, Mean corpuscular volume, Mean corpuscular haemoglobin, Mean corpuscular hemoglobin concentration, Neutrophils (ANC), Lymphocytes, Monocytes, Eosinophils, and Basophils. Clinical chemistry: Blood urea nitrogen, Potassium, Aspartate aminotransferase, Total and direct bilirubin Creatinine, Chloride, Alanine aminotransferase, Uric Acid, Glucose (fasting), Total Carbon dioxide , Gamma glutamyltransferase, Albumin, Sodium, Calcium, Alkaline phosphatase, Total Protein, and HbA1c. Urine: Specific gravity, pH, glucose, protein, blood and ketones and Microscopic examination. Only those with PCIs are displayed.|At any point from Baseline through follow-up visit.|ITT Population|||Participants|||Number
2687291|NCT01342926|Primary|Number of Participants With 12-lead Electrocardiogram (ECG) of Potential Clinical Importance (PCI)|12-lead ECG was obtained after 10 minutes rest in a supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected using the Fridericia's formula (QTcF). Abnormal-clinically significant (CS) ECG measurements are presented at indicated time points: Baseline, Month 6, Month 12, Month 18, early withdrawal and at follow-up visit. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).|Baseline, Month 6, Month 12, Month 18, early withdrawal and at follow-up visit|ITT Population|||Participants|||Number
2687292|NCT01342926|Primary|Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Heart Rate (HR)|Vital signs included HR of CCR at the indicated time points: Baseline, Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, Month 18, early withdrawal and at follow-up visit in sitting position. 'General' is an assessment time not relative to dosing. HR was defined as: low:< 40 beats per minute (bpm) and high: >100 bpm. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Only categories with at least one PCI value are presented.|Baseline, Month 0, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 7, Month 8, Month 9, Month 10, Month 11, Month 12, Month 13, Month 14, Month 15, Month 16, Month 17, Month 18, early withdrawal and at follow-up visit|ITT Population|||Participants|||Number
2687293|NCT01342926|Primary|Number of Participants With Vital Signs of Potential Clinical Importance (PCI) During the Treatment Period: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Vital signs included SBP and DBP of Potential Clinical Importance (PCI) at the indicated time points: Baseline, month 0, month 1, month 2, month 3, month 4, month 5, month 6, month 7, month 8, month 9, month 10, month 11, month 12, month 13, month 14, month 15, month 16, month 17, month 18, early withdrawal and at follow-up visit in sitting position. 'General' is an assessment time not relative to dosing. SBP was defined as: low: <85 millimeter of mercury (mmHg) and high: >160 mmHg and DBP was defined as: low:<45 mmHg and high: >100 mmHg. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Only categories with at least one PCI value are presented.|Up to 21 months|ITT Population|||Participants|||Number
2687294|NCT01342926|Primary|Number of Participants With Ocular or Non-ocular Serious Adverse Events (SAEs) During the Treatment Period||Up to 21 months|ITT Population|||Participants|||Number
2687295|NCT01342926|Primary|Number of Participants With Ocular or Non-ocular Adverse Events (AEs) During the Treatment Period|An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. It includes:1. Any abnormal laboratory test results or other safety assessments including those that worsen from Baseline, and felt to be clinically significant in the medical and scientific judgment of the Investigator 2.Exacerbation (increase in frequency/intensity) of a chronic or intermittent pre-existing condition 3. New conditions detected or diagnosed after screening visit 4. Signs, symptoms, or the clinical sequelae of a suspected interaction/suspected overdose of investigational product or a concomitant medication. AEs were presented as non-ocular and ocular AEs.|Up to 21 months|ITT Population: all participants that completed the observation period and Baseline visit, and were subsequently randomized to treatment and were administered at least one IV dose.|||Participants|||Number
2687521|NCT01340872|Secondary|Change in Haemoglobin Concentration From Baseline to Week 36 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 36 (FAS), after 12-week double-blind phase and then 24 weeks of open-label ST10 treatment|Baseline to Week 36 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
2687296|NCT01342926|Primary|Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye|Atrophic age-related macular degeneration (AMD) also called GA is characterized by thinning of the retinal pigment epithelium (RPE) and underlying choriocapillaris, as well as overlying photoreceptors in the macula. GA was evaluated by color FP at the indicated time points: screening, 6 months, 12 months and 18 months. Change from BL: (screening, month 6, 12 or 18 value minus BL value. Note screening occurs prior to BL). Only participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Efficacy Population: all participants in the Intent-to-Treat (ITT) Population who met the protocol defined inclusion criterion for area of GA assessed by color FP in the study eye in at least one visit from screening visit through BL visit, inclusive and had data of area of GA assessed by fundus autofluorescence images in the study eye for at least 75% of the visits (>=14 visits) from post-BL treatment month 2 visit to treatment month 19 visit.|Baseline (BL), 6 months, 12 months and 18 months|Efficacy Population. Participants who developed CNV in the study eye during the treatment period are excluded from Efficacy Population per protocol.|||square millimeter (m^2)||90% Confidence Interval|Mean
2687297|NCT01342913|Secondary|Change From Baseline in Trough FEV1 on Treatment Day 85|Pulmonary function was measured by forced expiratory volume in one second (FEV1). Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 85. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 85 values minus the Baseline value.|Baseline and Day 85|Only participants available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
2687298|NCT01342913|Secondary|Time to Onset on Treatment Day 1|Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 min, 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose.|Day 1|ITT Population. Only participants available at the indicated time point were assessed.|||Minutes||Full Range|Median
2687299|NCT01342913|Primary|Change From Baseline Trough in 24-hour Weighted-mean FEV1 on Treatment Day 84|Pulmonary function was measured by forced expiratory volume in one second (FEV1). The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30, and 60 minutes (min) and 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value.|Baseline and Day 84|Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least 1 dose of double-blind medication. Randomized participants were assumed to have received double-blind medication unless definitive evidence to the contrary existed. Only participants available at the indicated time point were assessed.|||Liters||Standard Error|Least Squares Mean
2687300|NCT01342887|Secondary|Frequency and Severity of Regimen-associated Toxicities|Estimate the frequency and severity of regimen-associated toxicities, along with 28-day mortality after start of study treatment|At 28 days||||Participants|||Count of Participants
2687301|NCT01342887|Secondary|Disease-free Survival of Patients That Achieve CR/CRi|Describe the disease-free survival of patients that achieve CR/CRi.|Up to 4.5 years||||Participants|||Count of Participants
2687302|NCT01342887|Secondary|CR/CRi|"Describe the disease-free survival of patients that achieve Complete Remission (CR)/CR with inadequate recovery of peripheral blood cell counts (CRi).~Categorized according to criteria recommended by an International Working Group."|After completion of first 2 courses, up to 22 weeks||||Participants|||Count of Participants
2687303|NCT01342887|Primary|Maximum Tolerated Doses Mitoxantrone Hydrochloride and Etoposide When Combined With Cyclosporine and Pravastatin Sodium|"Determine the doses of mitoxantrone and etoposide that, when combined with CSA and pravastatin, meet minimum standards for both efficacy and toxicity and have the highest efficacy rate among several mitoxantrone and etoposide doses.~Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0."|After completion of first 2 courses, up to 22 weeks||||doses tolerated|||Number
2687304|NCT01342770|Secondary|Post-intervention SUV of PET Scan|The pre- and post-intervention SUV will be summarized using descriptive statistics and simple graphical plots.|Time of surgery, after 42 days of treatment|Includes registered eligible participants with pre- and post-intervention PET/CT images obtained|||SUV||Full Range|Median
2687305|NCT01342770|Secondary|Pre-intervention SUV of PET Scan|The pre- and post-intervention SUV will be summarized using descriptive statistics and simple graphical plots.|Baseline|Includes registered eligible participants with pre- and post-intervention PET/CT images obtained|||SUV||Full Range|Median
2687306|NCT01342770|Secondary|Percent Change in SUVmax From the PET Scan|The percent change from pre to post-intervention in SUV max values will be summarized using descriptive statistics and simple graphical plots.|Baseline to the time of surgery, after 42 days of treatment|Includes registered eligible participants with pre- and post-intervention PET/CT images obtained|||Percent change in tumor SUV max values||Full Range|Median
2687307|NCT01342770|Secondary|Percent Change in PPARy|Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically.|Baseline to the time of surgery, after 42 days of treatment|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration|||Percent change in PPARy measurements||Full Range|Median
2687308|NCT01342770|Secondary|Percent Change in p21|Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically.|Baseline to the time of surgery, after 42 days of treatment|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration|||Percent change in p21 measurements||Full Range|Median
2687309|NCT01342770|Secondary|Percent Change in MUC1|Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically.|Baseline to the time of surgery, after 42 days of treatment|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration|||Percent change in MUC1 measurements||Full Range|Median
2689649|NCT01325181|Secondary|Number of Participants With Leakage on Fluorescein Angiography|number of participants who showed fluorescein leakage after primary or rescue treatment throughout the follow-up period|12 months|||||||
2687310|NCT01342770|Secondary|Percent Change in Cyclin D1|Changes in the expression levels from baseline (prior to intervention) to post intervention (resected tumor sample) will be plotted graphically.|Baseline to the time of surgery, after 42 days of treatment|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration|||Percent change in Cyclin D1 measurements||Full Range|Median
2687311|NCT01342770|Secondary|Number of Participants With Complete Pathologic Response|Complete pathologic response was defined as no viable residual tumor cells. Acellular residual mucin pools also considered a pathologic complete response.|Up to the time of surgery, after 42 days of treatment|Includes all registered participants|||participants|||Number
2687312|NCT01342770|Secondary|Number of Participants With Clinical Response, Based on Response Evaluation Criteria in Solid Tumors ( RECIST) Version 1.1|Clinical response rates will be summarized. Complete response (CR) is the disappearance of all non-nodal target lesions (TL) and each target lymph node (LN) must have reduction in short axis to <1.0cm. Partial Response (PR) is at least a 30% decrease in the sum of the longest diameters (LD) of the non-nodal TR and the short axis of the target LN with the baseline sum diameters (BSD) as reference. Progression (PD) is at least 1 new malignant lesion or LN whose short axis increased to >1.5 cm or at least a 20% increase in the sum of TL diameters with the minimum sum of diameters as reference.|Up to the time of surgery, after 42 days of treatment|Data not collected due to a study team decision not to analyze this endpoint.||||||
2687313|NCT01342770|Secondary|Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events Version 4.0|To evaluate the adverse events profile, the maximum grade for each type of adverse event will be recorded for each participant and frequency tables will be reviewed to determine the overall patterns. The number and severity of adverse events (both regardless of attribution as well as those that are at least possibly, probably, or definitely related) will be tabulated and summarized.|Up to the time of surgery, after 42 days of treatment|Includes all registered eligible participants|||participants|||Number
2687314|NCT01342770|Secondary|Gene Expression Analysis of RNA From Bronchial Brush Cells|For the gene expression profiles obtained from the data from normal bronchial brush cells, each participant's pre- and post gene expression will be graphically represented and the mean expression levels analyzed using a paired t-test or Wilcoxon signed rank test, if the assumptions of the t-test are not met.|Up to the time of surgery, after 42 days of treatment|Data not collected due to a study team decision not to analyze this endpoint.||||||
2687315|NCT01342770|Secondary|Change in Levels of Serum CRP|Each participant's pre- and post serum levels of CRP will be graphically represented and the mean levels analyzed using a paired t-test or Wilcoxon signed rank test, if the assumptions of the t-test are not met.|Baseline and at the time of surgery, after 42 days of treatment|Data not collected due to a study team decision not to analyze this endpoint.||||||
2687316|NCT01342770|Secondary|Change in Levels of Serum CA-153|Each participant's pre- and post serum levels of CA-153 will be graphically represented and the mean levels analyzed using a paired t-test or Wilcoxon signed rank test, if the assumptions of the t-test are not met.|Baseline and at the time of surgery, after 42 days of treatment|Data were not collected due to a study team decision not to analyze this endpoint.||||||
2687317|NCT01342770|Secondary|Change in Apoptosis Assessment (e.g., Caspase-3)|Changes in the expression levels (or grades) from baseline (prior to intervention) to post-intervention (resected tumor sample) will be plotted graphically as well as formally assessed using the McNemar's tests (for categorical variables) or Wilcoxon signed rank tests (for continuous variables) respectively.|Baseline and at the time of surgery, after 42 days of treatment|Data were not collected. Study team decision not to analyze this endpoint.||||||
2687318|NCT01342770|Primary|Percent Change in Ki-67 by Immunohistochemistry (IHC)|Changes in the expression levels of Ki-67 will be plotted graphically, and percent change in expression levels will be formally assessed using the paired t-test or the Wilcoxon signed rank test, if the assumptions of the t-test (i.e. normality) are not met.|Baseline and at the time of surgery, after 42 days of treatment|Includes all registered participants with pre- and post-intervention tumor tissue samples except one participant who was deemed ineligible post-registration|||Percent change in Ki-67 measurements||Full Range|Median
2687319|NCT01342757|Secondary|Mean Change in Metabolite Levels|Baseline MRS was performed 1-3 days before initiation of treatment. Follow-up MRS studies were performed at day 7. A standard quadrature head coil was used to collect MR data. The change of metabolite level in choline (Cho) and N-acetyl aspartate (NAA) were calculated in ratio by (metabolite after treatment / metabolite before treatment − 1). The reported ratios represent the Cho-to-NAA ratio at day 7 compared with day 0.|Baseline to 1 week||||Cho/NAA Ratios||Full Range|Mean
2687320|NCT01342757|Primary|Measurable Change on Magnetic Resonance Spectroscopy Imaging After Vorinostat Administration|Changes in magnetic resonance spectroscopic imaging signal and semiquantitative analysis of inositol, choline, lactate, and N-acetyl aspartate (NAA) signal are measured. The values for each of these metabolites are normalized to baseline at one and nine weeks. The values of all the metabolites at one week are added and this is the magnetic resonance spectroscopic index for one week. This is done again at nine weeks. The number is unitless and there is no range limit. Positive values represent normalization of tumor metabolism and negative values suggest no improvement or worsening of metabolic character.|9 weeks|Patients collected until measurable spectroscopic indexes were available in at least three cases with metabolic response and three without metabolic response|||Spectroscopic index||Standard Deviation|Mean
2687321|NCT01342757|Primary|Proportion of Patients Who Experience Metabolic Restoration Between the Responders and Non-responder Groups by MRS Scans|Baseline MRS was performed 1-3 days before initiation of treatment. Follow-up MRS studies were performed at day 7. A standard quadrature head coil was used to collect MR data. A responder was defined as stable disease: determined in glioblastoma to be between a 25% volume increase and 50% volume decrease compared to baseline imaging at the therapy initiation at the 2 month follow-up visit. The spectroscopic restoration index was calculated (ΔN-acetyl aspartate + Δcreatine + Δmyo-inositol − Δcholine − Δ(lactate / lipids)).|After 1 week|In five of the twelve cases spectroscopic indices could not be calculated because the tumor volume was outside of reliably measured voxels. These were primarily accounted for by tumor closeness to the skull or the small size of residual tumor.|||Participants|||Count of Participants
2689650|NCT01325181|Secondary|Change From Baseline in Central Foveal Thickness on OCT|the change from baseline in central foveal thickness measured by OCT throughout the follow-up period|12 months|||||||
2687322|NCT01342757|Primary|Proportion of Patients With Magnetic Resonance Spectroscopy (MRS) Response to Initial Vorinostat by MRI and MRS Scans as Determined by Spectroscopic Index|Changes in magnetic resonance spectroscopic imaging signal and semiquantitative analysis of inositol, choline, lactate, and N-acetylaspartate signal are measured. The values for each of these metabolites are normalized to baseline at one and nine weeks. The values of all the metabolites at one week are added and this is the magnetic resonance spectroscopic index for one week. This is done again at nine weeks. The number is unitless and there is no range limit. Positive values represent normalization of tumor metabolism and negative values suggest no improvement or worsening of metabolic character.|9 weeks||||participants|||Number
2687323|NCT01342666|Primary|High Density Lipoprotein Cholesterol (HDL-c)|To evaluate the effect of two daily tomatoes consumption on HDL-c levels.|Baseline and after one month|The sample size was calculated using the formula for means for two-tailed comparisons. According to a previous report, we expected a minimal change of 5 mg/dL in HDL-c after one month of consumption. Using a SD of 9 mg/dL with alfa of 0.05 and study power of 80%, a total of 48 subjects were calculated.|||mg/dL||Standard Deviation|Mean
2687324|NCT01342640|Primary|Change From Baseline in Mean Hb Concentration at Week 28|PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).|Baseline (Week 0), Week 28|PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome|||gm/dL||Standard Deviation|Mean
2687325|NCT01342640|Primary|Change From Baseline in Mean Hb Concentration at Week 24|PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).|Baseline (Week 0), Week 24|PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.|||gm/dL||Standard Deviation|Mean
2687326|NCT01342640|Primary|Change From Baseline in Mean Hb Concentration at Week 20|Per Protocol (PP) Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin less than or equal to [≤] 100 nanogram per milliliter [ng/mL] or mean transferrin saturation [TSAT] ≤20% or mean hypochromic red blood cells [RBCs] greater than or equal to [≥] 10% during efficacy evaluation period [Weeks 20 to 28]).|Baseline (Week 0), Week 20|PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome and n signifies those participants who were evaluable for specified time-point.|||Grams per deciliter (gm/dL)||Standard Deviation|Mean
2687327|NCT01342549|Primary|Time to Relapse to Heavy Drinking as Defined by Having 5 or More Drinks in a Sitting for Men and Will be Assessed Using the Time Line Follow Back for Recent Drinking Method. A Structured Questionnaire Will Review Alcohol Consumed on the Previous Week.||24 weeks||||Weeks||Standard Deviation|Mean
2687328|NCT01342523|Secondary|Increased Quit Attempts|Quit attempts will be defined in two ways: self-report of a serious attempt to quit, and occurrence of at least a 24 hr period of abstinence that was for the purpose of cessation.|Measured at the 1 month, 3 month and 7 month follow up assessments.|||||||
2687329|NCT01342523|Secondary|Treatment Satisfaction|We will measure how satisfied participants were with the resources they were given as well as what might have made their quit attempts easier or more successful.|Measured at the 1 month, 3 month and 7 month follow up assessments|||||||
2687330|NCT01342523|Secondary|Perceived Support|We will measure perceived support from both treatment and non-treatment resources.|Measured at the1 month, 3 month and 7 month follow up assessments.|||||||
2687331|NCT01342523|Secondary|Withdrawal Symptoms|We will measure the manifestation and severity of withdrawal symptoms of participants in each treatment group.|Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.|||||||
2687332|NCT01342523|Secondary|Effectiveness of the Experimental Resources.|We will measure how these experimental resources (as well as combinations of resources) aid in quit attempts and abstinence outcomes.|Data collected at all assessments (Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow ups), during web use measurements (6 months), and counseling calls measurements (4 weeks). Analyzed after the study.|||||||
2687333|NCT01342523|Secondary|Resource Use/Engagement|We will measure participants' use the experimental resources compared to the non-experimental resources. Particularly with the study websites, we will be tracking how often and how long participants use the regular smokefree.gov website versus the placebo website as well as what parts of the websites they are using for 6 months.|Assessed at the 7 month follow up assessment. Furthermore, Website use will be collected as pages viewed, time viewed, use occasions, and composite measures. Counseling use will be measured by number of counseling calls.|||||||
2687334|NCT01342523|Secondary|Smoking Outcomes|Inclusive of smoking rate amongst those smoking, smoking cessation milestones: initial cessation, lapse latency, lapse-relapse latency; and setting a quit date.|Measured at the1 week, 2 week, 3 week, 1 month, 3 month and 7 month follow up assessments.|||||||
2687335|NCT01342523|Primary|7-Day Point-Prevalence Abstinence From Smoking|Abstinence will be defined as 7-day point prevalence.|Measured after the 3 month follow up assessment|"Intention to treat (ITT)"|||percentage of participants not smoking|||Number
2687336|NCT01342510|Primary|Number of Patients With Pain Associated With Injection of Propofol.|"Ten seconds following injection of propofol, subjects were asked Are you having pain at your IV site? Any behavioral signs were noted. Injection pain was assessed using the following four point scale: 0 = no pain; 1 = mild pain (pain reported only in response to questioning and without behavioral signs); 2 = moderate pain (pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously without questioning); and 3 = severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal, or tears)."|< 1 minute.||||participants reporting pain|||Number
2687337|NCT01342510|Primary|Percentage of Participants Reporting Pain With Injection of Propofol|Following injection of the study drug, 50 mg of propofol will be injected. Ten seconds after propofol, subjects will be asked a standard question about pain. Behavioral signs will be noted. Pain will be assessed using a four point scale: 0=no pain, 1=mild pain (pain reported only in response to questioning and without behavioral signs), 2=moderate pain (pain reported in response to questioning and a behavioral sign, or pain reported without questioning), 3=severe pain (strong vocal response or behavioral response).|Approximately 10 seconds following administration of propofol.||||percentage of patients reporting pain||95% Confidence Interval|Number
2687338|NCT01342484|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) After 12 Weeks of Treatment|Change from baseline in FPG (mmol/L) after 12 weeks of treatment with double-blind trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest.|Baseline and 12 weeks|Full analysis set (FAS) including all randomised patients who were treated with at least one dose of study drug and had a baseline and at least one on-treatment HbA1c assessment. Observed Case (OC): In the OC analysis, values after the use of rescue medication were set to missing.|||mmol/L||Standard Error|Least Squares Mean
2687339|NCT01342484|Secondary|Dipeptidyl-peptidase-4 (DPP-4) Inhibition (%) at Trough at Steady State|DPP-4 inhibition (%) at trough at steady state is the relative change between the measurement of DPP-4 activity taken 0.5 hours before dosing at baseline and the first available on-treatment measurement of DPP-4 activity taken 0.5 hour before dosing at week 4, 8 or 12: DPP-4 inhibition (%) = 100 - (DPP-4 activity at week X / DPP-4 activity at baseline) x 100.|Baseline and 4 weeks or 8 weeks or 12 weeks|Full analysis set (FAS) including all randomised patients who were treated with at least one dose of study drug and had a baseline and at least one on-treatment HbA1c assessment. OR (Original Results). The analysis excludes placebo patients and 1 FAS patient from Linagliptin 1 mg group.|||Percentage of DPP-4 inhibition||Inter-Quartile Range|Median
2687340|NCT01342484|Primary|Change From Baseline in Glycosylated Haemoglobin (HbA1c) (%) After 12 Weeks of Treatment|Change from baseline in Glycosylated haemoglobin (HbA1c) [%] after 12 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The number of participants analysed displays the number of participants with available data at the timepoint of interest.|Baseline and 12 weeks|Full analysis set (FAS) including all randomised patients who were treated with at least one dose of study drug and had a baseline and at least one on-treatment HbA1c assessment. Observed Case (OC): In the OC analysis, values after the use of rescue medication were set to missing.|||Percentage of HbA1c||Standard Error|Least Squares Mean
2687341|NCT01342471|Secondary|TV Viewing Time|Change in self-reported TV viewing time per day between 0 and 6 months|0 and 6 months||||hr/day||Standard Deviation|Mean
2687342|NCT01342471|Secondary|Weight|Change in weight in kgs between 0 and 6 months|0 and 6 months||||kg||Standard Deviation|Mean
2687343|NCT01342471|Secondary|TV Related Energy Intake|Change in energy intake (kcals/day) while watching TV between 0 and 6 months|0 and 6 months||||kcals/day||Standard Deviation|Mean
2687344|NCT01342471|Secondary|Total Energy Intake|Change in total energy intake(kcals/day) between 0 and 6 months|0 and 6 months||||kcals/day||Standard Deviation|Mean
2687345|NCT01342471|Primary|Physical Activity (Steps/Day)|Change in pedometer measured steps per day between 0 and 6 months|0 and 6 months||||steps/day||Standard Deviation|Mean
2687346|NCT01342458|Secondary|Paracetamol Intake|Paracetamol intake (500 mg), number of tablets per month.|6 month||||tablets per month||Inter-Quartile Range|Median
2687347|NCT01342458|Secondary|First Peak of the Knee Adduction Moment (KAM) During Gait.|The first peak of the external knee moment was calculated by mean inverse dynamics approach. To this procedure, we used the kinematics data of the lower limbs assessed with six infrared cameras and the ground reaction force evaluated by mean a force platform. This is a continuous measure.|6 month||||% body weight x height in centimeters||Standard Deviation|Mean
2687348|NCT01342458|Secondary|Six-minute Walk Test|The six-minute walk test assesses distance in meters walked over 6 minutes.|6 month||||meter||Standard Deviation|Mean
2687349|NCT01342458|Secondary|Global Score of the Lequesne´s Questionaire Algo-functional.|This questionaire consists of three sections (eleven questions): about pain or discomfort, the maximum distance that the patient can walk, and activities of daily living. Scores range from zero to twenty-four, meaning cases without involvement and with extremely severe impairment, respectively.|6 month||||score||Standard Deviation|Mean
2687350|NCT01342458|Secondary|WOMAC Total Score|The WOMAC total score is the sum of all subscale (pain, function and stiffness) (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items ranges from 0 to 96. Higher scores on the WOMAC total score indicate worse condition.|6 month||||score||Standard Deviation|Mean
2687351|NCT01342458|Secondary|WOMAC Physical Function Subscale|The physical function subscale included in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) index consists of seventeen questions (Likert Scale) relating to the patient's physical activities, or skills to move out and take care of themselves. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of physical function subscale ranges from 0 to 68. Higher scores on the physical function WOMAC subscale indicate worse functional limitations.|6 month||||score||Standard Deviation|Mean
2687352|NCT01342458|Secondary|WOMAC Stiffness Subscale|The stiffness subscale included in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) index consists of two questions (Likert Scale) relating articular function of the patient. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of the stiffness subscale ranges from 0 to 8. Higher scores on the stiffness WOMAC subscale indicate worse articular function.|6 month||||score||Standard Deviation|Mean
2687375|NCT01342172|Primary|Maximum Tolerated Dose (MTD) of Lenalidomide|MTD was determined by testing planned increasing doses up to 25 mg daily dose on days 1-14, starting at 10mg. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in > 33% of participants. DLTs were defined as any lenalidomide-related Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE 4.0) Grade 3 or 4 adverse events|after 1 cycle (each cycle is 21 days)|The dose of lenalidomide was not escalated beyond 10 mg because of cytopenias requiring repeated dose delays and reductions.|||mg|||Number
2687353|NCT01342458|Primary|Western Ontario and McMaster Universities (WOMAC) Pain Subscale|The WOMAC (Western Ontario and McMaster Universities) pain subscale consists of five questions (Likert Scale) relating to the patient's pain in everyday situations. The Likert Scale version used for all WOMAC items are: none, mild, moderate, severe, and extreme. The sum of all items of pain subscale ranges from 0 to 20. Higher scores indicate worse pain.|6 month|An intention-to-treat analysis was performed, and the missing data were treated as missing completely at random (MCAR) using the Mahalanobis imputation method (SOLAS software version 4.0; Statistical Solutions Ltd., Cork, Ireland).|||score||Standard Deviation|Mean
2687354|NCT01342445|Primary|Behavior Rating Inventory of Executive Function - Adult (BRIEF-A)|BRIEF-A is a standardized self-report measure that captures adults' views of their own self-regulation in their everyday environment. Metacognition Index T-scores (mean = 50; standard deviation = 10) were used as dependent measures with higher scores representing greater deficit in planning/organizational skills critical for college success.|after receiving Placebo or LDX for 1 week||||T score||Standard Deviation|Mean
2687355|NCT01342445|Primary|Conners Adult ADHD Rating Scale - Short Version (CAARS)|CAARS ADHD Index, adult self-report measure of ADHD symptoms. T-scores (mean = 50; standard deviation = 10) for all subscales on the short version were used as dependent measures with higher scores representing greater ADHD symptomatology (and ultimately a worse outcome in this study).|after receiving Placebo or LDX for 1 week||||T score||Standard Deviation|Mean
2687356|NCT01342341|Primary|Alcohol Consumption in Drinks/Week.|Each subject will record how many drinks/week they are consuming while on the study drug and placebo during the 45-day study. The primary outcome of this study is to determine the effect of chlorzoxazone on alcohol consumption. Reduction in alcohol consumption is measured utilizing behavioral inventories, electronic diaries, urine, and ethyl glucuronide.|45 days||||number of drinks||Standard Deviation|Mean
2687357|NCT01342211|Other Pre-specified|Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141|Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 29, 57, 71, 85, 99, 127, 141|Efficacy analysis set. 'number analyzed' = participants who were evaluable for specified time points for each arm. Results for percent change at Day 85 in Lp(a) was not reported because data was not collected for Lp(a) at Day 85 due to an inadvertent omission in the protocol.|||percent change||Standard Deviation|Mean
2687358|NCT01342211|Other Pre-specified|Change From Baseline in Lipoprotein (a) (Lp[a]) at Day 29, 57, 71, 85, 99, 127 and 141|Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 29, 57, 71, 85, 99, 127, 141|Efficacy analysis set. 'number analyzed' = participants who were evaluable for specified time points for each arm. Results for change at Day 85 in Lp(a) was not reported because data was not collected for Lp(a) at Day 85 due to an inadvertent omission in the protocol.|||mg/dL||Standard Deviation|Mean
2687359|NCT01342211|Secondary|Number of Participants With Anti-drug Antibody (ADA)|Human serum ADA samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 (RN316) antibodies by using the semi quantitative enzyme-linked immunosorbent assay (ELISA). Results with titer value >=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure.|Day 1 up to Day 141|Analysis set included all participants who received at least 1 dose of PF-04950615 (RN316).|||participants|||Number
2687360|NCT01342211|Secondary|Number of Participants With Clinically Significant Changes in Vital Signs and Electrocardiogram (ECG) Parameters|Criteria for clinical significant vital signs: maximum increase or decrease from baseline in supine systolic blood pressure (BP) greater than or equal to (>=) 30 millimeter of mercury (mmHg), maximum increase or decrease from baseline in supine diastolic BP of >=20 mmHg. Criteria for clinically significant ECG parameters: maximum increase of >=25 percent (%) for baseline value of >200 millisecond (msec) and maximum increase of >=50% for baseline value of less than or equal to (<=) 200 msec for PR and QRS interval; maximum increase from baseline of >30 to <=60 msec and maximum increase from baseline of >60 msec for QT interval corrected using the Fridericia's formula (QTCF).|Day 1 up to Day 141|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2687361|NCT01342211|Secondary|Number of Participants With Clinically Relevant Laboratory Abnormalities|Hematology (hemoglobin[hgb],hematocrit,red blood cell[RBC]<0.8*lower limit of normal[LLN],mean cell[MC] volume,MC hgb,MC hg concentration <0.9*LLN, greater than[>] 1.1*upper limit of normal[ULN], platelet <0.5*LLN,>1.75*ULN, white blood cell[WBC]<0.6*LLN,>1.5*ULN,neutrophil,lymphocyte <0.8*LLN,>1.2*ULN,eosinophil,basophil,monocyte >1.2*ULN);chemistry(total, direct, indirect bilirubin[BR]>1.5*ULN,aspartate aminotransferase[AT],alanine AT,alkaline phosphatase,gamma-glutyl transferase>3.0*ULN,protein,lactate dehydrogenase <0.8*LLN,>1.2*ULN,creatinine,blood urea nitrogen>1.3*ULN,uric acid >1.2*ULN,potassium,chloride,calcium,bicarbonate<0.9*LLN,>1.1*ULN, sodium<0.95*LLN,>1.05*ULN,glucose[GL]<0.6*LLN,>1.5*ULN,amylase,lipase >1.5*ULN,creatinine kinase>2.0*ULN);urinalysis(pH <4.5,>8,specific gravity<1.003 , >1.030, GL,ketone,protein,hgb,BR,nitrite,leukocyte greater than or equal to [>=]1, RBC, WBC >=20);coagulation(prothrombin[PT],PT international ratio,partial thromboplastin time>1.1*ULN).|Day 1 up to Day 141|Safety analysis set included all participants who received at least 1 dose of study drug. Here 'N' signifies those participants who were evaluable for this outcome measure.|||participants|||Number
2687362|NCT01342211|Secondary|Number of Treatment-Emergent Adverse Events (TEAEs) by Severity|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Investigator assessed TEAEs as mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) or severe (interfered significantly with participant's usual function). TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state.|Day 1 up to Day 141|Safety analysis set included all participants who received at least 1 dose of study drug.|||adverse events|||Number
2687390|NCT01341782|Secondary|Percentage of Participants With Target Intact Parathyroid Hormone (iPTH)|The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.|The last three weeks of treatment (Weeks 11, 12, and 13)|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2697167|NCT01263717|Secondary|HbA1c|Hemoglobin A1c.|6 months|All available data were used; data were not available for one subject.|||Change in %||95% Confidence Interval|Mean
2687363|NCT01342211|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are events between first dose of study drug and up to Day 141 that were absent before treatment or that worsened relative to pretreatment state. Treatment related: a TEAE deemed related to the study drug by the investigator. TEAEs included SAEs (TESAEs) as well as non-serious AEs which occurred during the study. The participants with TEAEs, SAEs and treatment-related TEAEs were reported.|Day 1 up to Day 141|Safety analysis set included all participants who received at least 1 dose of study drug.|||participants|||Number
2687364|NCT01342211|Secondary|Percent Change From Baseline in Lipid Parameters at Day 29, 57 and 85|Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 29, 57, 85|Efficacy analysis set. 'number analyzed' = participants who were evaluable at specified time points for each arm. Results for percent change at Day 85 for ApoB and ApoA1 were not reported because data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol.|||percent change||Standard Deviation|Mean
2687365|NCT01342211|Secondary|Change From Baseline in Lipid Parameters at Day 29, 57 and 85|Lipid parameters included: high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), non-high-density lipoprotein-cholesterol (non-HDL-C), triglyceride (TG), apolipoprotein B (ApoB) and apolipoprotein A1 (ApoA1). Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 29, 57, 85|Efficacy analysis set. 'number analyzed' = participants who were evaluable at specified time points for each arm. Results for change at Day 85 in lipid parameters ApoB and ApoA1 were not reported because data was not collected for ApoB and ApoA1 at Day 85 due to an inadvertent omission in the protocol.|||milligram per deciliter (mg/dL)||Standard Deviation|Mean
2687366|NCT01342211|Secondary|Percentage of Participants Achieving at Least 30 Percent Decrease in Low-density Lipoprotein Cholesterol (LDL-C)||Day 29, 57, 85|Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. 'N' = participants who were evaluable for this outcome measure and 'number analyzed' = participants who were evaluable at specified time points for each arm.|||percentage of participants|||Number
2687367|NCT01342211|Secondary|Percentage of Participants Achieving Low-density Lipoprotein Cholesterol (LDL-C) Less Than (<) 70 and <100 Milligram Per Deciliter (mg/dL)||Day 29, 57, 85|Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. 'N' = participants who were evaluable for this outcome measure and 'number analyzed' = participants who were evaluable at specified time points for each arm.|||percentage of participants|||Number
2687368|NCT01342211|Primary|Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Day 85|Baseline value was calculated as the average of Day 7 and Day 1 measurements collected prior to study drug administration.|Baseline, Day 85|Efficacy analysis set included all participants who received at least 1 dose of study drug and completed the Day 85 visit or dropped out prematurely, whichever was earlier. Here 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.|||percent change||Standard Deviation|Mean
2687369|NCT01342172|Secondary|To Determine the Impact of Treatment on Circulating Tumor Cells|Circulating epithelial tumor cells (CTC) will be investigated as an experimental endpoint using immunofluorescence techniques and CTC identification by positive expression of epithelial markers and a viability marker and negative expression of hematopoietic markers. These analyses will only be done in the phase II portion of the protocol.|Day 1 of Cycles 0, 1 and 2 (each Cycle is 21 days)|Data not collected.||||||
2687370|NCT01342172|Secondary|To Determine the Impact of Treatment on Peripheral Blood Immune Cell Subsets|To determine the changes in cellular immunity with lenalidomide in peripheral blood mononuclear cells including Tregs, NK, NKT cells (Berg et al JCO 2010), sIl-2R, TNF alpha (Bartlett et al BJC 2004) and markers indicative of activation, i.e. CD107a. These analyses will only be done in the phase II portion of the protocol.|Day 1 of Cycle 0 and Day 1 of Cycle 2 (each Cycle is 21 days)|Data not collected||||||
2687371|NCT01342172|Secondary|Best Overall Response|"Best Overall Response to evaluate lenalidomide as maintenance treatment in patients achieving an objective response of either complete response or partial response following completion of 6 cycles of combination therapy.~Complete Response (CR) - CR of target lesions and no new lesions Partial Response (PR) -PR of target lesions and no new lesions Stable Disease (SD) - SD of target lesions and no new lesions Progression Disease (PD) - any status of target lesions and new lesions"|168 days||||Participants|||Count of Participants
2687372|NCT01342172|Secondary|Number of Grade >=3 Adverse Events|Number of grade >=3 adverse events to assess the safety of combination therapy with gemcitabine, cisplatin plus lenalidomide as determined by the frequency and severity of adverse events as per the NCI Common Terminology for Adverse Events (CTCAE) version 4.0.|Day 1 and Day 8 of each treatment cycle; 21 days after the last dose of Lenalidomide||||events|||Number
2687373|NCT01342172|Secondary|The Objective Response Rate to Treatment With Gemcitabine, Cisplatin, Plus Lenalidomide|"The objective response rate as determined by Response Evaluation Criteria in Solid Tumors (RECIST).~Complete Response (CR) Disappearance of all target lesions for a period of at least one month.~Partial Response (PR) At least a 30% decrease in the sum of the longest diameter of measures lesions (target lesions), taking as reference the baseline sum of the longest diameter.~Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of the longest diameter since the treatment started.~Progressive Disease (PD) A 20% or greater increase in the sum of the longest diameter of measured lesions (target lesions), taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions"|After 2 cycles (a cycle is 21 days)||||Participants|||Count of Participants
2687374|NCT01342172|Primary|Phase II: Progression-free Survival at 1 Year||1 year|Data not collected.||||||
2687376|NCT01342107|Primary|Lens Wettability|As assessed by the investigator during slit-lamp exam and rated on a 0-4 scale, with 0 = a smooth uniformly reflecting wettable surface; 1 = a coarse hazy wettable surface which seems resolved momentarily with each blink and becomes exacerbated with staring; 2 = one stable dry (non-wetting) area of some magnitude; 3 = more than one stable dry (non-wetting) area of some magnitude; 4 = non-wettable lens surface of severe magnitude. Lenses with a Grade 0 or 1 were rated as wettable and reported as a percentage of total lenses evaluated.|16 hours|Intent to treat. All subject-eyes that received contact lenses pre-soaked per treatment regimen and completed Visit 2 (Day 1 - Exit at 16 hours) were included in the ITT data set.|||percentage of lenses||95% Confidence Interval|Number
2687377|NCT01342094|Primary|Change From Baseline in Mean Diurnal IOP (Intraocular Pressure) at End of Study|Mean diurnal IOP (intraocular pressure) was calculated as an average of IOP (intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.|Week 0(Baseline) and Week 4(End of Study)||||mmHg||Standard Deviation|Mean
2687378|NCT01342081|Primary|Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study|Mean diurnal IOP(intraocular pressure) was calculated as an average of IOP(intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.|Week 0(Baseline) and Week 4(End of Study)||||mmHg||Standard Deviation|Mean
2687379|NCT01342029|Secondary|Cardiac Magnetic Resonance (CMRs)|"Cardiac Magnetic Resonance (CMRs) (CMR 1 and CMR 2) end of the 2nd week of treatment 1 and treatment 2 respectively, 4 hours after the morning dose of study drug was performed to measure myocardial perfusion reserve index.~Myocardial perfusion reserve index (MPRI) was assessed using the first-pass perfusion intensity curves during stress and rest cardiac magnetic resonance imaging. First-pass perfusion images were analysed using CAAS MRV CMRI analysis software Version 3.3 (Pie Medical Imaging B.V., Maastricht, the Netherlands). Global MPRI was calculated as the ratio of stress/rest relative perfusion upslope, corrected for LV cavity upslope.~Higher MPRI represents better myocardial perfusion reserve. Since MPRI is an index, there is no unit."|2 weeks (first intervention) and 6 weeks (second intervention)|Out of 142 randomized, there were 10 dropouts and 4 missing treatment periods. Therefore 128 was included in analysis|||myocardial perfusion reserve index||Standard Deviation|Mean
2687380|NCT01342029|Primary|Seattle Angina Questionnaire (SAQ)|"Questionnaires will be completed (SAQ - Seattle Angina Questionnaire) at the end of each treatment period.~The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and quality of life. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. A change of 10 points in any of the subscales is considered to be clinically important."|2 weeks (first intervention) and 6 weeks (second intervention)|Not all participants answered every question in the SAQ, thus the numbers are different for each question.|||Units on scale||Standard Deviation|Mean
2687381|NCT01341990|Primary|Mean Ex-Vivo Advancing Contact Angle|Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.|Day 8, 16 hours|Intent to treat.|||Degrees||Standard Deviation|Mean
2687382|NCT01341990|Primary|Mean Ex-Vivo Advancing Contact Angle|Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.|Day 1, 8 hours|Intent to Treat.|||Degrees||Standard Deviation|Mean
2687383|NCT01341977|Primary|Subjective Acceptance|Lens Moisture Subject Rated Likert Item (1-Strongly Agree to 5-Strongly Disagree)|Day 90||||Subjective Rating||Standard Deviation|Mean
2687384|NCT01341977|Primary|Subjective Acceptance|Lens Moisture Subject Rated Likert item|Day 90|||||||
2687385|NCT01341912|Secondary|To Determine Long-term Efficacy of Human-cl rhFVIII in the Treatment of Bleeding Episodes and in Surgical Prophylaxis|"The efficacy of human-cl rhFVIII will be determined using a 4 point efficacy assessment scale.~After each infusion of IMP and at the end of a BE, the following efficacy assessment is made by the subject (together with the Investigator in case of on-site treatment):~Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion.~Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 - 12 hours after an infusion requiring up to 2 infusions for complete resolution.~Moderate: Probable or slight beneficial effect within approximately 12 hours after the first infusion requiring more than two infusions for complete resolution.~None: No improvement within 12 hours, or worsening of symptoms, requiring more than 2 infusions for complete resolution.~The assessment was made at the end of a BE in case more than one infusion was needed."|up to 3 years||||percentage of bleeding episodes|Bleeding episodes||Number
2687386|NCT01341912|Primary|Long-term Immunogenicity|Patients will be monitored for inhibitors against FVIII every 3 months. Blood samples were drawn and inhibitor activity was determined by the modified Bethesda assay (Nijmegen modification) in the central lab.|up to 3 years||||occurrence of inhibitors|||Number
2687387|NCT01341782|Secondary|Number of Visits at Which Participants Achieved iPTH Control in the Target Range of 60 to 180 pg/mL|iPTH control was defined as being within the target range of 60 to 180 pg/mL. iPTH was measured before the first dialysis session of the week, once a week during the treatment phase and analyzed by the central laboratory.|Weeks 2 to 13|Full analysis set|||visits||Standard Deviation|Mean
2687388|NCT01341782|Secondary|Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline|iPTH control was defined as a ≥ 50% reduction from baseline. iPTH was measured before the first dialysis session of the week, each week during the treatment phase and analyzed by the central laboratory.|Weeks 2 to 13|Full analysis set|||visits||Standard Deviation|Mean
2687389|NCT01341782|Secondary|Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline|The percentage of participants with a greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.|Baseline to the last three weeks of treatment (Weeks 11, 12, and 13)|Full analysis set|||percentage of participants||95% Confidence Interval|Number
2687391|NCT01341782|Secondary|Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia|The percentage of participants with greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment and with no hypercalcemia during the treatment phase. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory. Hypercalcemia was defined as at least 1 corrected calcium value > 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL.|Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) for iPTH. Calcium measured throughout the study (Weeks 1-13).|The Full Analysis Set (FAS) consists of all randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline iPTH measurement.|||percentage of participants||95% Confidence Interval|Number
2687392|NCT01341782|Primary|Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia|The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment, and with no hypercalcemia during the treatment phase. Hypercalcemia was defined as at least 1 corrected calcium value > 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.|iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13).|The per-protocol set (PPS) consists of all randomized patients who completed at least 8 weeks of treatment and met the conditions specified by the subject classification (i.e., no violation of inclusion/exclusion criteria) that occurred before the study blind was broken.|||percentage of participants||95% Confidence Interval|Number
2687393|NCT01341639|Secondary|Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination|Solicited systemic AEs were defined as crying, decreased appetite, irritability, pyrexia (rectal temperature ≥38.0°C), somnolence, and vomiting occurring from D1 to D5 after vaccination. The investigator assessed whether these systemic AEs were related or not to the vaccines. All (related and unrelated) AEs are reported.|Day 1 to Day 5 after any vaccination|All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded.|||Percentage of participants|||Number
2687394|NCT01341639|Secondary|Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination|Unsolicited ISRs with incidence ≥1% after any vaccination were reported daily on the VRC by the parent(s) or legal representative from (D1-D15). AEs at injection sites were always considered as vaccine-related ISRs|Day 1 to Day 15 after any vaccination|All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded.|||Percentage of participants|||Number
2687395|NCT01341639|Secondary|Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination|Solicited ISRs were defined as injection-site erythema, injection-site pain, and injection-site swelling occurring from Day 1 (D1) to Day 5 (D5) after vaccination. AEs at injection sites were always considered as vaccine-related (Injection-Site Reactions (ISRs)).|Day 1 to Day 5 after any vaccination|All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded.|||Percentage of participants|||Number
2687396|NCT01341639|Secondary|Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination|Global safety was assessed by measuring injection-site and systemic AEs reported daily on the Vaccination Report Card (VRC) by the parent(s) or legal representative from Day 1 to Day 15 (D1-D15) after each hexavalent vaccination. Solicited injection-site and systemic AEs were reported daily from Day 1 to Day 5 (D1-D5) after each hexavalent vaccination. AEs at injection sites were always considered as vaccine-related (Injection-Site Reactions (ISRs)). The investigator assessed whether systemic AEs were related (V-related) or not to the vaccine. All AEs (related and unrelated) are reported.|Day 1 to Day 15 after any vaccination|All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded.|||Percentage of participants|||Number
2687397|NCT01341639|Secondary|Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old|Ab titres were measured by ELISA, excepting the Ab to varicella which was determined by glycoprotein ELISA. Percentage of participants with an Ab titre ≥255 mIU/mL for measles, ≥10 Ab units/mL for mumps, ≥10 IU/mL for rubella, and ≥5 gpELISA units/mL for varicella are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.|One month after Toddler dose of PRI5 (13 months old)|All participants who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Toddler dose. Participants from site 0048 were excluded.|||Percentage of participants|||Number
2687398|NCT01341639|Secondary|Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old|Ab titres were measured by ELISA, excepting the Ab to varicella which was determined by glycoprotein ELISA. Percentage of participants with an Ab titre ≥255 mIU/mL for measles, ≥10 Ab units/mL for mumps, ≥10 IU/mL for rubella, and ≥5 gpELISA units/mL for varicella are reported. 95% CI were calculated based on the exact binomial method by Clopper and Pearson. The immune response to ProQuad vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits: 90% for measles, mumps & rubella, and 76% for varicella.|One month after Toddler dose of PRI5 (13 months old)|All participants in the PR5I group who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Toddler dose. Participants from site 0048 were excluded. Participants in the INFANRIX™ hexa group were not analyzed for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2687409|NCT01341470|Secondary|Pharmacokinetics, Time of Maximum Observed Drug Concentration (Tmax)||Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs Postdose|All participants who received study drug and had evaluable Tmax data were analyzed.|||hours (h)||Full Range|Median
2692047|NCT01305564|Secondary|Rate of Recurring Pulmonary Embolism|Rate of recurrent Pulmonary Embolism while the filter is indwelling or one month post-retrieval.|24 months||||percentage of participants||95% Confidence Interval|Number
2687399|NCT01341639|Primary|Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old|Antibody titres were measured by ECi for HBsAg and ELISA for PT, FHA, & PRN. Percentage of participants with an Ab titre ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 & 3, and seroresponse to PT, FHA, and PRN are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.|One month after Toddler dose of PRI5 (13 months old)|All participants who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Toddler dose. Participants from site 0048 were excluded.|||Percentage of participants|||Number
2687400|NCT01341639|Primary|Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months|Antibody titres were measured by RIA for PRP, MIT for diphtheria & poliovirus, and ELISA for tetanus. Percentage of participants with an Ab titre ≥0.15 μg/mL for Hib) (PRP); ≥0.01 IU/mL; for diphtheria & tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 & 3 (IPV1, 2 & 3) are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.|One month after post-dose 3 of PRI5 (5 months old)|All participants who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Dose 3. Participants from site 0048 were excluded.|||Percentage of participants|||Number
2687401|NCT01341639|Primary|Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months|Antibody titres in the PR5I group were measured by RIA for PRP, MIT for diphtheria & poliovirus, enhanced Chemiluminescence assay (ECi)) for Hepatitis B surface antigen (HBsAg) and ELISA for tetanus, Pertussis toxoid (PT), Filamentous haemagglutinin (FHA), Fimbriae types 2 & 3 (FIM) & Pertactin (PRN). Percentage of participants with an Ab titre ≥1.0 μg/mL for Hib (PRP); ≥0.1 IU/mL; for diphtheria & tetanus; ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 & 3, and seroresponse to PT, FHA, FIM and PRN are reported. 95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson. The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the lower CI limits for PRP, PT, FHA, FIM, and PRN (75%); Diphtheria (80%); HBsAG, IPV 1, 2, 3 (90%).|One month after Toddler dose of PRI5 (13 months old)|All participants in the PR5I group who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Toddler dose. Participants from site 0048 were excluded. Participants in the INFANRIX™ hexa group were not analyzed for this outcome measure.|||Percentage of participants||95% Confidence Interval|Number
2687402|NCT01341639|Primary|Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months|Antibody titres in the PR5I group were measured by Radioimmunoassay (RIA) for Haemophilus influenzae type b (PRP), Micrometabolic inhibition test (MIT) for diphtheria & poliovirus, and Enzyme-Linked Immunosorbent Assay (ELISA) for tetanus. Percentage of participants with an Ab titre ≥0.15 μg/mL for Haemophilus influenzae type b (Hib) (polyribosylribitol phosphate, PRP); ≥0.01 IU/mL; for diphtheria & tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 & 3 (IPV1, 2 & 3) are reported. 95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson. The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits for PRP, diphtheria (80%), tetanus (90%), and IPV1, 2 & 3 (90%).|One month after post-dose 3 of PRI5 (5 months old)|All participants in the PR5I group who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within revised windows (RW) of Days 28 to 51 Post-Dose 3. Participants from site 0048 were excluded. Participants in the INFANRIX™ hexa group were not analyzed.|||Percentage of participants||95% Confidence Interval|Number
2687403|NCT01341600|Primary|Change in Platelet Aggregation Following Therapy With Clopidogrel|ADP mediated platelet aggregation measured 4 hours post Day 8 clopidogrel dose|4 hours post Day 8 dose||||percentage of aggregation||Standard Deviation|Mean
2687404|NCT01341600|Secondary|Level of Active Clopidogrel Metabolite|The level of the active clopidogrel metabolite will be measured at at 0.25, 0.5, 1, 2, and 4 hours after the Day One dose is administered for pharmacokinetic analysis. The analysis will measure the Area Under the Curve.|Baseline, 0.25, 0.5, 1, 2, and 4 hours||||ng h/mL||Standard Deviation|Mean
2687405|NCT01341600|Secondary|Change in Platelet Aggregation Following Therapy With Clopidogrel and Omeprazole|The change in maximum platelet aggregation in response to ADP 4-hours post dose on day 8 of therapy with clopidogrel and omeprazole will be compared to the baseline measure of platelet aggregation at day 1 prior to drug therapy|Baseline, Day 8||||percentage of aggregation||Standard Deviation|Mean
2687406|NCT01341600|Primary|Change in Platelet Aggregation Following Therapy With Clopidogrel|Adenosine diphosphate (ADP) mediated platelet aggregation measured 4 hours post-dose of clopidogrel on Day 1.|Day 1, 4 hours post clopidogrel dose||||percentage of aggregation||Standard Deviation|Mean
2687407|NCT01341587|Primary|Change in HbA1c|Determine whether this intervention leads to significant improvements in patient HbA1c from baseline to 6 months|6 months|Results for change were not collected because the study was stopped. Participants were lost to follow-up and stopped using the meters||||||
2687408|NCT01341470|Secondary|Percentage Change in Thigh Muscle Volume|Thigh muscle volume was determined by Magnetic Resonance Imaging (MRI) scan of the right leg thigh muscle. Percentage change in thigh muscle volume=(time point value-baseline value)*100. Change from baseline for muscle volume was analyzed using mixed model repeated measures (MMRM) model with fixed effects of treatment, time and treatment*time interaction and a random effect of subject where baseline values were included as a covariate.|Baseline, Day 22 for a single dose arm/ baseline, Days 22 and 71 for multiple dose arms|All randomized participants who received at least one dose of study drug.|||percentage change||Standard Deviation|Mean
2687522|NCT01340872|Secondary|Change in Haemoglobin Concentration From Baseline to Week 24 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 24 (FAS), after 12-week double-blind phase and then 12 weeks of open-label ST10 treatment|Baseline to Week 24 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
2687410|NCT01341470|Secondary|Pharmacokinetics, Area Under the Concentration Versus Time Curve (AUC)|Area under the concentration curve (AUC) time zero to infinity (0-inf) was calculated for single dose administration and AUCtau (AUCτ) at steady state was calculated for multiple dose administration.|Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs Postdose|All participants who received study drug and had evaluable AUC data were analyzed.|||nanomoles*hour per milliliter(nmol*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2687411|NCT01341470|Secondary|Pharmacokinetics, Maximum Concentration (Cmax)||Single Dose:Day 1:Predose,10 minutes before end,2,6,12,24,48,192,360,528,696,1032,1368and2040 hours(hrs)Postdose;Multiple Dose:Day 1:Predose,24,48,96,168,264,360,528,696,1032hrs Postdose; Day57:Predose,24,48,96,168,336,672and1680hrs Postdose|All participants who received study drug and had evaluable Cmax data were analyzed.|||picomoles per milliliter (pmol/mL)||Geometric Coefficient of Variation|Geometric Mean
2687412|NCT01341470|Primary|Number of Participants With Clinically Significant Effects|Clinically significant effects are defined as treatment emergent adverse events (TEAEs) which in the opinion of the investigator are thought to be possibly related to study drug. A summary of serious and all other non-serious adverse events (whether or not related to study drug) is located in the Reported Adverse Events module.|Baseline to study completion (up to 135 days)|All randomized participants|||Participants|||Count of Participants
2687413|NCT01341457|Secondary|PK: AUC(0-∞) of Gemcitabine Metabolite dFdU||Cycle 1 (days 1 and 15) & 2 (day 1): Predose, End of Infusion, 10 minutes (m), 30m, 60m, 120m|All randomized participants who received at least one dose of study drug and have had PK samples collected.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2687414|NCT01341457|Secondary|PK: AUC(0-∞) of Gemcitabine||Cycle 1 (days 1 and 15) & 2 (day 1): Predose, End of Infusion, 10 minutes (m), 30m, 60m, 120m|All randomized participants who received at least one dose of study drug and have had PK samples collected.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2687415|NCT01341457|Secondary|PK: Cmax of Gemcitabine Metabolite Deoxydifluorouridine (dFdU)||Cycle 1 (days 1 and 15) & 2 (day 1): Predose, End of Infusion, 10 minutes (m), 30m, 60m, 120m|All randomized participants who received at least one dose of study drug and have had PK samples collected.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2687416|NCT01341457|Secondary|PK: Cmax of Gemcitabine||Cycle 1 (days 1 and 15) & 2 (day 1): Predose, End of Infusion, 10 minutes (m), 30m, 60m, 120m|All randomized participants who received at least one dose of study drug and have had PK samples collected.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2687417|NCT01341457|Secondary|PK: Area Under the Plasma Concentration vs. Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2603618||Cycle 1 (days 2 and 16) & 2 (day 2): Predose, End of Infusion, 1 hour (h), 3h, 6h, 24h (days 3 and 17), 48h (days 4 and 18 cycle 1 only), 72h (days 5 and 19)|All randomized participants who received at least one dose of study drug and have had PK samples collected.|||nanograms*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2687418|NCT01341457|Secondary|Number of Participants With Best Overall Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Best Overall Response)|Participants achieved disease control if they had a best overall response of PR, CR or SD according to RECIST v1.1 (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD); PR at least 30% decrease and PD at least 20% increase in the sum of diameter of target lesions; CR: disappearance of all target lesions). Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR. Best response of SD is defined as disease that does not meet the criteria for CR, PR or PD and has been evaluated at least 6 weeks after the first gemcitabine administration.|Baseline to Measured Progressive Disease (Up to 52 Months)|All randomized participants who received at least one dose of study drug and had measurable lesion(s).|||participants|||Number
2687419|NCT01341457|Secondary|Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2603618||Cycle 1 (days 2 and 16) & 2 (day 2): Predose, End of Infusion, 1 hour (h), 3h, 6h, 24h (days 3 and 17), 48h (days 4 and 18 cycle 1 only), 72h (days 5 and 19)|All randomized participants who received at least one dose of study drug and have had PK samples collected.|||Nanograms per Milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2687420|NCT01341457|Primary|Number of Participants With Dose Limiting Toxicity (DLT)|DLT is defined as adverse event (AE) during Cycle 1 (Days 1 through 28) that was possibly related to the study drug and toxicities considered by the investigator as dose limiting. A summary of other nonserious AEs, and all serious adverse events (SAE's), regardless of causality, is located in the Reported Adverse Events section.|Cycle 1 (28 Days)|Participants who completed the first cycle of study treatment or who discontinued study treatment due to a DLT. There was one participant in the 170 mg LY2603618 treatment group that had an insufficient number of doses of gemcitabine to evaluate DLT.|||Participants|||Count of Participants
2687421|NCT01341444|Primary|Number of Participants With Surgical Site Complications (SSCs)|The primary objective to compare short-term surgical incision-related clinical outcomes in Subjects undergoing open renal transplant surgery when treated with Prevena vs. the standard-of-care wound dressing. Clinical outcomes of interest are defined as Surgical Site Complications (SSCs) that include incisional fluid accumulation (i.e. seroma, hematoma, abscess), dehiscence, surgical site infection (SSI). These outcomes will be compared to a control group consisting of subjects screened for the same inclusion/exclusion criteria but treated with standard-of-care incision dressing.|62 Days|Analysis of this endpoint was based on the Full analysis Set (FAS population). The FAS population consists of participants who met all of the pre- and intra-operative eligibility criteria, were randomized and received treatment. Subjects without SSC must have received 5 days of Prevena or at least 3 days of SOC dressing and completed 30 day visit.|||Participants|||Count of Participants
2687422|NCT01341301|Secondary|Incidence and Severity of GVHD, Graded According to Standard Criteria|Reported descriptively|Assessed up to 1 year|Data were not collected||||||
2687423|NCT01341301|Secondary|Regimen Related Toxicities Graded According to the National Cancer Institute (NCI) Common Toxicity Criteria, Version 3.0|Reported descriptively|Assessed up to 1 year|Data were not collected||||||
2687424|NCT01341301|Secondary|Pace of T-cell and B-cell Immune Recovery|Reported descriptively|Assessed up to 1 year|Data were not collected||||||
2687425|NCT01341301|Primary|Number of Participants That Experience One Year Relapse Free Survival After Undergoing Hematopoietic Stem Cell Transplant (HSCT)|To assess relapse free survival in participants undergoing Hematopoietic Stem Cell Transplant (HSCT) using the Thomas Jefferson University 2 step approach with an extra day inserted between the donor lymphocyte infusion (DLI) and administration of cyclophosphamide.|1 year after undergoing hematopoietic stem cell transplant||||Participants|||Count of Participants
2687426|NCT01341067|Secondary|Change in Basal Insulin Dose From Baseline Values||Assessed at baseline and 6 months||||units of insulin||Standard Deviation|Mean
2687427|NCT01341067|Secondary|Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl||Measured at baseline and 6 months||||percentage of time spent >180 mg/dl||Standard Deviation|Mean
2687428|NCT01341067|Secondary|Percentage of Time Spent at Glycemic Levels <65 mg/dl||Measured at baseline and at 6 months||||percentage of time spent < 65 mg/dl||Standard Deviation|Mean
2687429|NCT01341067|Primary|Change in HgbA1c||Measured at 6 months||||percentage of glycosylated hemoglobin||Standard Deviation|Mean
2687430|NCT01340976|Secondary|Mean Change From Baseline in Reticulocyte Count|Mean change in reticulocyte count from baseline to the end of Cycle 4.|Baseline, Cycle 4 (7-day cycle)|Evaluable Population in Part B is defined as a participant who has received all 4 of the first 4 per-cycle doses of study dose, maintained at least 60% compliance with oral iron therapy during the first 4 cycles of LY2787106 (if enrolled to the oral iron cohort), and who has had a hemoglobin assessment after each of the first 4 doses.|||percentage of reticulytes||Standard Deviation|Mean
2687431|NCT01340976|Secondary|Change From Baseline in Serum Iron|Mean change in serum iron from baseline to the end of Cycle 4.|Baseline, Cycle 4 (7-day cycle)|Evaluable Population in Part B is defined as a participant who has received all 4 of the first 4 per-cycle doses of study dose, maintained at least 60% compliance with oral iron therapy during the first 4 cycles of LY2787106 (if enrolled to the oral iron cohort), and who has had a hemoglobin assessment after each of the first 4 doses.|||micromole per liter (umol/L)||Standard Deviation|Mean
2687432|NCT01340976|Secondary|Recommended Dose for Future Studies: Maximum Tolerated Dose (MTD)|"MTD is defined as being the highest tested dose below the level at which one-third or more of participants experience a Dose-limiting toxicity (DLT). DLT is defined as an adverse event occurring in any part of the study that is related to the study medication, occurs during Cycle 1 of Part A, and fulfills any one of the following criteria:~Clinically significant Grade 2 toxicity, such as angina, arrhythmia, seizure, dyspnea, rash with significant blistering or desquamation, or other event deemed significant by either the investigator.~≥Grade 3 anemia (excluding participants with baseline <9.0 g/dL) or hemoglobin (Hb) decrease >1.0 g/dL if baseline Hb <9.0 g/dL, confirmed by 2 independent measurements.~≥ Grade 3 cytokine release syndrome/acute infusion reaction.~Other ≥ Grade 3 hematological or non-hematological toxicity."|Baseline to Cycle 1 of Part A|MTD was not determined in this study, so zero participants were analyzed.||||||
2687433|NCT01340976|Secondary|PK: Area Under the Curve (AUC[0-∞])|AUC is the area under the concentration versus time curve from time zero to infinity.|Days 1, 2, and 4 of Cycles 1 and 5, Day 1 of Cycles 2, 3, 4, 6, 7 and 8 (Part A 21-day cycles, Part B 7-day cycles) and 1, 3, and 9 weeks after the last infusion|All participants who received at least 1 dose of study drug and who had evaluable PK data for AUC[0-∞]).|||micrograms∙hour per milliliter (µg∙h/mL)||Standard Deviation|Mean
2687434|NCT01340976|Secondary|Pharmacokinetics (PK): Maximum Concentration (Cmax)|Cmax is the maximum serum concentration after a single IV dose of the study drug.|Days 1, 2, and 4 of Cycles 1 and 5, Day 1 of Cycles 2, 3, 4, 6, 7 and 8 (Part A 21-day cycles, Part B 7-day cycles) and 1, 3, and 9 weeks after the last infusion|All participants who received at least 1 dose of study drug and who had evaluable PK data for Cmax.|||nanogram per milliliter (ng/ml)||Standard Deviation|Mean
2687435|NCT01340976|Primary|Mean Change From Baseline in Hemoglobin With or Without Oral Iron Supplementation|This analysis assesses the mean change in Hemoglobin from baseline to the end of Cycle 4. The analysis was carried separately for Cohort B1 without supplemental iron and Cohort B2 with supplemental iron.|Baseline, Cycle 4 (7-day cycle)|Evaluable population in Part B is defined as a participant who received all 4 of the first 4 per-cycle doses of study medication, maintained at least 60% compliance with oral iron therapy during the first 4 cycles of LY2787106 (if enrolled to the oral iron cohort), and who had a hemoglobin assessment after each of the first 4 doses.|||grams per deciliter (g/dL)||Standard Deviation|Mean
2687436|NCT01340976|Primary|Number of Participants With Clinically Significant Events|Number of participants with one or more treatment emergent adverse event (TEAE) or any Serious AE (SAE). A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.|Baseline to Study Completion (up to 5 Years)|All participants who received at least 1 dose of study drug.|||participants|||Number
2687437|NCT01340937|Secondary|Percentage of Participants With Elevated Temperature by Severity|Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was >=38.0°C.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population defined as all vaccinated participants with safety follow up and temperature data. This outcome applied only to V419 Lots A, B, and C Combined and Control; therefore, data for the individual V419 lots are not reported.|||Percentage of participants|||Number
2687438|NCT01340937|Secondary|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions|Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, >5 cm. Grade 3 Solicited systemic reactions: Fever (Pyrexia), >=39.5°C rectal; Vomiting, >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness (Somnolence), Sleeping most of the time or difficult to wake up; Appetite lost, Refuses >=3 feeds or refuses most feeds; Irritability, Inconsolable.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in these analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up. This outcome applied only to V419 Lots A, B, and C Combined and Control; therefore, data for the individual V419 lots are not reported.|||Percentage of participants|||Number
2687439|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes|Participant serum samples were collected for testing with a multiplex electrochemiluminescence-based detection assay for serotype-specific pneumococcal polysaccharide antibodies. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||µg/mL||95% Confidence Interval|Geometric Mean
2687440|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||Percentage of participants||95% Confidence Interval|Number
2687441|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||Percentage of participants||95% Confidence Interval|Number
2687442|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||Percentage of participants||95% Confidence Interval|Number
2687443|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||Percentage of participants||95% Confidence Interval|Number
2687444|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||EU/mL||95% Confidence Interval|Geometric Mean
2687445|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||EU/mL||95% Confidence Interval|Geometric Mean
2687446|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||EU/mL||95% Confidence Interval|Geometric Mean
2687447|NCT01340937|Secondary|Geometric Mean Concentration of Antibodies to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||EU/mL||95% Confidence Interval|Geometric Mean
2687448|NCT01340937|Secondary|Percentage of Participants Responding to Poliovirus Type 3|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687517|NCT01340872|Secondary|Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 16 (Full Analysis Set, FAS)|Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 16 (Full Analysis Set), after 12-week double-blind phase and first 4 weeks of open-label ST10 treatment|Baseline to Week 16 - open-label phase|FAS|||Participants|||Count of Participants
2687449|NCT01340937|Secondary|Percentage of Participants Responding to Poliovirus Type 2|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687450|NCT01340937|Secondary|Percentage of Participants Responding to Poliovirus Type 1|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687451|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687452|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687453|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687454|NCT01340937|Secondary|Percentage of Participants Responding to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687455|NCT01340937|Secondary|Percentage of Participants Responding to Tetanus Toxin|Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer >=0.1 IU/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687456|NCT01340937|Secondary|Percentage of Participants Responding to Diphtheria Toxin|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer >=0.1 IU/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687457|NCT01340937|Secondary|Percentage of Participants Responding to Hepatitis B Surface Antigen|Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer >=10 mIU/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687458|NCT01340937|Primary|Geometric Mean Titer for Antibodies to Poliovirus Type 3|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Titer||95% Confidence Interval|Geometric Mean
2687459|NCT01340937|Primary|Geometric Mean Titer for Antibodies to Poliovirus Type 2|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Titer||95% Confidence Interval|Geometric Mean
2687518|NCT01340872|Secondary|Change in Haemoglobin Concentration From Baseline to Week 64 EOS (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 64 EOS (FAS) - Week 64 was re-categorised as Week 64 EOS for those subjects who withdrew from the study early and the 'Week 64' visit was outside the visit window of 64 weeks ± 2 days|Baseline to Week 64 EOS - open-label phase|FAS|||g/dL||Standard Deviation|Mean
2687460|NCT01340937|Primary|Geometric Mean Titer for Antibodies to Poliovirus Type 1|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. The unit of measure is titer (reciprocal of highest dilution with neutralizing activity).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Titer||95% Confidence Interval|Geometric Mean
2687461|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||EU/mL||95% Confidence Interval|Geometric Mean
2687462|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||EU/mL||95% Confidence Interval|Geometric Mean
2687463|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||EU/mL||95% Confidence Interval|Geometric Mean
2687464|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||EU/mL||95% Confidence Interval|Geometric Mean
2687465|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Tetanus Toxin|Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for anti-tetanus antibodies.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||IU/mL||95% Confidence Interval|Geometric Mean
2687466|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Diphtheria Toxin|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. The unit of measure is International Units/mL (IU/mL).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||IU/mL||95% Confidence Interval|Geometric Mean
2687467|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen|Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. The unit of measure is milli International Units/mL (mIU/mL).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||mIU/mL||95% Confidence Interval|Geometric Mean
2687468|NCT01340937|Secondary|Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen|Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for a titer >=0.15 µg/mL and >=1.0 µg/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687469|NCT01340937|Primary|Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen|Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||µg/mL||95% Confidence Interval|Geometric Mean
2687470|NCT01340898|Secondary|Number of Subjects With Serious Adverse Events (SAEs)|Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.|From Day 0 to Month 19|The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase.|||Participants|||Count of Participants
2687471|NCT01340898|Secondary|Number of Subjects With New Onset of Chronic Illnesses (NOCIs)|NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.|From Day 0 to Month 19|The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase.|||Participants|||Count of Participants
2687472|NCT01340898|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) (Booster Phase)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Day 0-30) post booster vaccination|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects at booster time point (at Month 13).|||Participants|||Count of Participants
2687473|NCT01340898|Secondary|Number of Subjects With Unsolicited Adverse Events (AEs) (Primary Phase)|An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.|Within 31 days (Day 0-30) post each primary vaccine dose|The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase.|||Participants|||Count of Participants
2687474|NCT01340898|Secondary|Number of Subjects With Solicited General Symptoms (Booster Phase)|Assessed solicited general symptoms were temperature [defined as rectally temperature equal to or above 38 degrees Celsius (°C)], drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 8 days (Day 0-7) post booster vaccination|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects at booster time point (at Month 13) who had their symptom sheets completed.|||Participants|||Count of Participants
2687475|NCT01340898|Secondary|Number of Subjects With Solicited General Symptoms (Primary Phase)|Assessed solicited general symptoms were temperature [defined as rectally temperature equal to or above 38 degrees Celsius (°C)], drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.|Within 8 days (Day 0-7) post primary vaccination|The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase who had their symptom sheets completed.|||Participants|||Count of Participants
2687476|NCT01340898|Secondary|Number of Subjects With Solicited Local Symptoms (Booster Phase)|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|Within 8 days (Day 0-7) post booster vaccination|The analysis was performed on the Booster Total Vaccinated cohort, which included all vaccinated subjects at booster time point (at Month 13) who had their symptom sheets completed.|||Participants|||Count of Participants
2687477|NCT01340898|Secondary|Number of Subjects With Solicited Local Symptoms (Primary Phase)|Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.|Within 8 days (Day 0-7) post primary vaccination|The analysis was performed on the Primary Total Vaccinated cohort, which included all vaccinated subjects during the primary phase who had their symptom sheets completed.|||Participants|||Count of Participants
2687478|NCT01340898|Secondary|Anti-PRP Antibody Concentrations (Geometric Mean Concentrations) in a Randomized Subset of 25% of the Subjects|The endpoints evaluating immunogenicity of the Hib component (anti-polyribosyl ribitol phosphate [anti-PRP] antibody concentrations) has been cancelled owing to the extended delay in the re-development and re-validation of the PRP assay.|At Month 5 (one month post-dose 3)|No subjects were analyzed because the endpoints evaluating immunogenicity of the Hib component (anti-polyribosyl ribitol phosphate [anti-PRP] antibody concentrations) has been cancelled owing to the extended delay in the re-development and re-validation of the PRP assay.||||||
2687479|NCT01340898|Secondary|Number of Subjects With Anti-tetanus (Anti-T) Antibodies|Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.|At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)|The analysis was performed on the Adapted TVC, which included all vaccinated subjects during the primary phase.|||Participants|||Count of Participants
2687480|NCT01340898|Secondary|Concentration of Antibodies Against Tetanus Antigens (Anti-T)|Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).|At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)|The analysis was performed on the ATP cohort for immunogenicity adapted for each timepoint, which included all eligible subjects, who complied with the vaccination schedule and for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 25% of subjects of all three groups.|||IU/mL||95% Confidence Interval|Geometric Mean
2687481|NCT01340898|Secondary|Number of Subjects With Anti-tetanus (Anti-T) Antibodies|Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)|The analysis was performed on the ATP cohort for immunogenicity adapted for each timepoint, which included all eligible subjects, who complied with the vaccination schedule and for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 25% of subjects of all three groups.|||Participants|||Count of Participants
2687482|NCT01340898|Secondary|Antibody Titers for Anti-polio Type 1, 2 and 3 Antibodies|Antibody titers are presented as geometric mean titers (GMTs). The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.|At Month 5 (one month post-dose 3)|The analysis was performed on the Primary TVC, which included all vaccinated subjects during the primary phase.|||Titers||95% Confidence Interval|Geometric Mean
2687519|NCT01340872|Secondary|Change in Haemoglobin Concentration From Baseline to Week 64 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and then 52 weeks of open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
2687483|NCT01340898|Secondary|Antibody Titers for Anti-polio Type 1, 2 and 3 Antibodies|Antibody titers are presented as geometric mean titers (GMTs).|At Month 5 (one month post-dose 3)|The analysis was performed on a randomized subset of 25% in the primary ATP cohort for immunogenicity who complied with the protocol criteria and for whom data concerning immunogenicity endpoint measures were available, for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination.|||Titers||95% Confidence Interval|Geometric Mean
2687484|NCT01340898|Secondary|Concentration of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) Antigens|Concentrations are presented as geometric mean concentrations (GMCs) expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).|At Month 5 (one month post-dose 3)|The analysis was performed on the Primary TVC, which included all vaccinated subjects during the primary phase.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2687485|NCT01340898|Secondary|Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Immunoglobulin G (IgG) Antibodies|Cut-off values assessed were greater than or equal to ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).|At Month 5 (one month post-dose 3)|The analysis was performed on the Primary TVC included all vaccinated subjects during the primary phase.|||Participants|||Count of Participants
2687486|NCT01340898|Secondary|Concentration of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) Antigens|Concentrations are presented as geometric mean concentrations (GMCs) expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).|At Month 5 (one month post-dose 3)|The analysis was performed on a randomized subset of 25% in the primary ATP cohort for immunogenicity who complied with the protocol criteria and for whom data concerning immunogenicity endpoint measures were available, for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination.|||EL.U/mL||95% Confidence Interval|Geometric Mean
2687487|NCT01340898|Secondary|Concentration of Antibodies Against Diphtheria Antigens (Anti-D)|Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL). The analysis was performed in a randomized subset of 25% of subjects of all three groups. Note: As the percentage of subjects with serological results excluded from the ATP cohorts was higher than 5%, a second analysis based on the total vaccinated cohorts (TVCs) (Primary and Booster) was performed to complement the ATP analysis.|At Month 5 (one month post-dose 3)|The analysis was performed on the Primary TVC, which included all vaccinated subjects during the primary phase.|||IU/mL||95% Confidence Interval|Geometric Mean
2687488|NCT01340898|Secondary|Concentration of Antibodies Against Diphtheria Antigens (Anti-D)|Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).|At Month 5 (one month post-dose 3)|The analysis was performed on a randomized subset of 25% in the primary ATP cohort for immunogenicity who complied with the protocol criteria and for whom data concerning immunogenicity endpoint measures were available, for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination.|||IU/mL||95% Confidence Interval|Geometric Mean
2687489|NCT01340898|Secondary|Number of Subjects With Anti-diphtheria (Anti-D) Antibodies|Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).|At Month 5 (one month post-dose 3)|The analysis was performed on a randomized subset of 25% in the primary ATP cohort for immunogenicity who complied with the protocol criteria and for whom data concerning immunogenicity endpoint measures were available, for antibodies against at least one study vaccine antigen component after at least one vaccination during the primary vaccination.|||Participants|||Count of Participants
2687490|NCT01340898|Secondary|Anti-pneumococcal Antibody Concentrations|Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (µg/mL)|At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 25% of all subjects.|||μg/mL||95% Confidence Interval|Geometric Mean
2687491|NCT01340898|Secondary|Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL)|The anti-pneumococcal serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|At Months 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 25% of all subjects.|||Participants|||Count of Participants
2687492|NCT01340898|Secondary|Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL).|The anti-pneumococcal serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.|At Months 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 25% of all subjects.|||Participants|||Count of Participants
2687493|NCT01340898|Secondary|Number of Subjects With Booster Responses for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group|Vaccine/Booster response was defined as: for seronegative subjects (rSBA titers < 1:4 pre-vaccination at Month 13), antibody titer ≥ 1:32 at post vaccination; for seropositive subjects (rSBA titers >= 1:4 pre-vaccination at Month 13), antibody titer at post vaccination ≥ 4-fold the pre vaccination.|At Month 14 (one month after the booster dose in Nimenrix 3+1 and Nimenrix 1+1 and post-vaccination in Nimenrix Control Group)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 75% of subjects from each group.|||Participants|||Count of Participants
2687494|NCT01340898|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (Pre-booster for Nimenrix 3+1 and 1+1 Groups and Pre-vaccination for Nimenrix Control, and Post-booster for Nimenrix 3+1 and 1+1 Groups and Post-vaccination for Nimenrix Control)|Antibody titers are presented as geometric mean titers (GMTs).|At Month 13 (pre-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and pre-vaccination for Nimenrix Control), and at Month 14 (post-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and post-vaccination for Nimenrix Control)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 75% of subjects from each group.|||Titers||95% Confidence Interval|Geometric Mean
2687495|NCT01340898|Secondary|Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control)|The cut-off value for the hSBA titers was ≥ 1:4 and ≥ 1:8.|At Month 13 (pre-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and pre-vaccination for Nimenrix Control), and at Month 14 (post-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and post-vaccination for Nimenrix Control)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 75% of subjects from each group.|||Participants|||Count of Participants
2687496|NCT01340898|Secondary|hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (One Month Post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)) -Randomized Subset of 50% of Subjects of All Three Groups|Antibody titers are presented as geometric mean titers (GMTs).|At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 50% of subjects from each group.|||Titers||95% Confidence Interval|Geometric Mean
2687497|NCT01340898|Secondary|Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y Antibody Titers Greater Than or Equal to (≥) the Cut-off Values (One Month Post-primary for Nimenrix 3+1 and 1+1 Groups)|The cut-off value for the hSBA titers was ≥ 1:4 and ≥ 1:8.|At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects for whom data concerning immunogenicity endpoint measures were available. The analysis was performed in a randomized subset of 50% of subjects from each group.|||Participants|||Count of Participants
2687498|NCT01340898|Secondary|Number of Subjects With Booster Responses for rSBA-MenA, C rSBA-MenC, Y rSBA-MenY and W-135 rSBA-MenW-135 in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group|Vaccine/Booster response was defined as: for seronegative subjects (rSBA titers < 1:8 pre-vaccination at Month 13), antibody titer ≥ 1:32 at post vaccination; for seropositive subjects (rSBA titers >= 1:8 pre-vaccination at Month 13), antibody titer at post vaccination ≥ 4-fold the pre vaccination antibody titer.|At Month 14 (one month post-booster dose for Nimenrix 3+1 and Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)|The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects, who complied with the vaccination schedule at Month 13 (booster dose for Nimenrix 3+1 and Nimenrix 1+1 and first dose in Nimenrix Control) and for whom data concerning immunogenicity endpoint measures were available|||Participants|||Count of Participants
2687499|NCT01340898|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers for Nimenrix 1+1 and Nimenrix Control Groups|Antibody titers are presented as geometric mean titers (GMTs).|At Months 5 (one month post-primary dose for Nimenrix 1+1 Group), 13 (prior booster dose for Nimenrix 1+1 and prior primary dose for Nimenrix Control Group) and 14 (post booster dose Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects, who complied with the vaccination schedule and for whom data concerning immunogenicity endpoint measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2687500|NCT01340898|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups|The cut-off values for the rSBA antibody titers were ≥ 1:8 and ≥ 1:128|At Months 5 (one month post-primary dose for Nimenrix 1+1 Group), 13 (prior booster dose for Nimenrix 1+1 and prior primary dose for Nimenrix Control Group) and 14 (post booster dose for Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects, who complied with the vaccination schedule and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2687501|NCT01340898|Secondary|rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers One Month Post Dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group|Antibody titers are presented as geometric mean titers (GMTs).|At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects, who complied with the vaccination schedule and for whom data concerning immunogenicity endpoint measures were available.|||Titers||95% Confidence Interval|Geometric Mean
2687502|NCT01340898|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:128, One Month Post-dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group|The cut-off value for the rSBA titers was ≥ 1:128|At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects, who complied with the vaccination schedule and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2687793|NCT01339000|Secondary|Evaluate and Quantify the Impact of Interleukin-7 (CYT107) Therapy on the T Cell Receptor Diversity in Older Subjects Following Chemotherapy||10 weeks|Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.||||||
2687503|NCT01340898|Secondary|Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:8 Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group|The cut-off value for the rSBA titers was ≥ 1:8|At Month 13 (prior booster) and at Month 14 (one month after the booster dose)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects, who complied with the vaccination schedule and for whom data concerning immunogenicity endpoint measures were available.|||Participants|||Count of Participants
2687504|NCT01340898|Primary|Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Against Neisseria Meningitidis Serogroups Antibody Titers Greater Than or Equal to (≥) 1:8, One Month Post Dose 3 for the Nimenrix 3+1 Group|The cut-off value for the rSBA titers was ≥ 1:8. Neisseria meningitidis serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) antibodies were assessed.|At Month 5 (one month post-dose 3)|The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity adapted for each timepoint, which included all eligible subjects, who complied with the vaccination schedule and for whom data concerning immunogenicity endpoint measures were available. This endpoint was specified to be analysed for the Nimenrix 3+1 Group only.|||Participants|||Count of Participants
2687505|NCT01340872|Other Pre-specified|Change From Baseline in Simple Clinical Colitis Activity Index (SCCAI) Score at Week 64 (Full Analysis Set)|"Change from baseline in Simple Clinical Colitis Activity Index (SCCAI) score at Week 64 (FAS), after 12-week double-blind phase and 52 weeks open-label ST10 treatment (in participants with UC only).~The SCCAI is a diagnostic and research questionnaire used to assess the severity of symptoms in people who suffer from UC. The calculated score ranges from 0 to 19, where active disease is a score of 5 or higher.~The score is determined by asking the person with UC questions regarding:~bowel frequency at day/night~urgency of defecation~blood in stool~general health~extracolonic manifestations"|Baseline to Week 64 - open-label phase|FAS|||score on a scale||Full Range|Median
2687506|NCT01340872|Other Pre-specified|Change From Baseline in Simple Clinical Colitis Activity Index (SCCAI) Score at Week 12 (Full Analysis Set, FAS)|"Change from baseline in Simple Clinical Colitis Activity Index (SCCAI) score at Week 12 (FAS), end of double-blind phase (in subjects with UC).~The SCCAI is a diagnostic and research questionnaire used to assess the severity of symptoms in people who suffer from UC. The calculated score ranges from 0 to 19, where active disease is a score of 5 or higher.~The score is determined by asking the person with UC questions regarding:~bowel frequency at day/night~urgency of defecation~blood in stool~general health~extracolonic manifestations"|Baseline to Week 12 - double-blind phase|FAS - participants with UC only|||score on a scale||Full Range|Median
2687507|NCT01340872|Other Pre-specified|Irritable Bowel Disease Questionnaire (IBDQ) Score at Week 64 (Full Analysis Set, FAS)|"Irritable Bowel Disease Questionnaire (IBDQ) score at Week 64 (FAS), after 12-week double-blind phase and 52 weeks of open-label ST10 treatment.~The IBDQ was developed as an activity index for determining the effect of Ulcerative Colitis symptoms on perceived quality of life. It is a 32-item questionnaire with four dimensions: bowel function, emotional status, systemic symptoms and social function. Total IBDQ score ranges from 32 to 224, with higher scores indicating better quality of life. The score of patients in remission usually is between 170 and 190."|Week 64 - open-label phase|FAS|||score on a scale||Standard Deviation|Mean
2687508|NCT01340872|Other Pre-specified|Irritable Bowel Disease Questionnaire (IBDQ) Score at Week 12 (Full Analysis Set, FAS)|"Irritable Bowel Disease Questionnaire (IBDQ) score at Week 12 (FAS), end of double-blind phase.~The IBDQ was developed as an activity index for determining the effect of Ulcerative Colitis symptoms on perceived quality of life. It is a 32-item questionnaire with four dimensions: bowel function, emotional status, systemic symptoms and social function. Total IBDQ score ranges from 32 to 224, with higher scores indicating better quality of life. The score of patients in remission usually is between 170 and 190."|Week 12 - double-blind phase|FAS|||score on a scale||Standard Deviation|Mean
2687509|NCT01340872|Other Pre-specified|Change in Serum TSAT% From Baseline to Week 64 (Full Analysis Set, FAS)|Change in serum TSAT% from Baseline to Week 64 (Full Analysis Set), after 12-week double-blind phase and 52 weeks open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS|||% serum TSAT||Standard Deviation|Mean
2687510|NCT01340872|Other Pre-specified|Change in Serum TSAT% From Baseline to Week 12 (Full Analysis Set, FAS)|Change in serum TSAT% from Baseline to Week 12 (FAS), after 12-week double-blind phase|Baseline to Week 12 - double-blind phase|FAS|||% serum TSAT||Standard Deviation|Mean
2687511|NCT01340872|Other Pre-specified|Change in Serum Ferritin Concentration From Baseline to Week 64 (Full Analysis Set, FAS)|Change in serum Ferritin concentration from Baseline to Week 64 (FAS), after 12-week double-blind phase and 52 weeks open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS|||μg/dL||Standard Deviation|Mean
2687512|NCT01340872|Other Pre-specified|Change in Serum Ferritin Concentration From Baseline to Week 12 (Full Analysis Set, FAS)|Change in serum Ferritin concentration from Baseline to Week 12 (Full Analysis Set), after 12-week double-blind phase|Baseline to Week 12 - double-blind phase|FAS|||μg/dL||Standard Deviation|Mean
2687513|NCT01340872|Other Pre-specified|Change in Haemoglobin Concentration From Baseline to Week 12 (Full Analysis Set [FAS] LOCF)|ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the FAS LOCF - Change in Haemoglobin Concentration from Baseline to Week 12|Baseline to Week 12 - double-blind phase|FAS LOCF - sensitivity analysis of primary endpoint|||g/dL||Standard Error|Least Squares Mean
2687514|NCT01340872|Other Pre-specified|Change in Haemoglobin Concentration From Baseline to Week 12 (Per Protocol Analysis Set, PPAS)|ANCOVA sensitivity analysis of the Primary efficacy endpoint analysis on the PPAS - Change in Haemoglobin Concentration from Baseline to Week 12|Baseline to Week 12 - double-blind phase|Per-Protocol Analysis Set - sensitivity analysis of primary endpoint|||g/dL||Standard Error|Least Squares Mean
2687515|NCT01340872|Secondary|Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 64 (Full Analysis Set, FAS)|Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 64 (Full Analysis Set), after 12-week double-blind phase and 52 weeks of open-label ST10 treatment|Baseline to Week 64 - open-label phase|FAS|||Participants|||Count of Participants
2687516|NCT01340872|Secondary|Proportion of Subjects That Achieved Haemoglobin Concentration Within Normal Range at Week 36 (Full Analysis Set, FAS)|Proportion of subjects that achieved Haemoglobin Concentration within normal range at Week 36 (Full Analysis Set), after 12-week double-blind phase and 24 weeks of open-label ST10 treatment|Baseline to Week 36 - open-label phase|FAS|||Participants|||Count of Participants
2687523|NCT01340872|Secondary|Change in Haemoglobin Concentration From Baseline to Week 20 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 20 (FAS), after 12-week double-blind phase and then 8 weeks of open-label ST10 treatment|Baseline to Week 20 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
2687524|NCT01340872|Secondary|Change in Haemoglobin Concentration From Baseline to Week 16 (Full Analysis Set, FAS)|Change in Haemoglobin Concentration from Baseline to Week 16 (FAS), after 12-week double-blind phase and first 4 weeks of open-label ST10 treatment.|Baseline to Week 16 - open-label phase|FAS|||g/dL||Standard Deviation|Mean
2687525|NCT01340872|Secondary|Change in Hb Concentration From Baseline to Week 8 (Full Analysis Set, FAS)|ANCOVA analysis of Change in Hb concentration from Baseline to Week 8 of double-blind phase - FAS, multiple imputation|Baseline to Week 8 - double-blind phase|FAS|||g/dL||Standard Deviation|Mean
2687526|NCT01340872|Secondary|Change in Hb Concentration From Baseline to Week 4 (Full Analysis Set, FAS)|ANCOVA analysis of the change in Hb concentration from Baseline to Week 4 of the double-blind phase - Full Analysis Set, multiple imputation|Baseline to Week 4 - double-blind phase|FAS|||g/dL||Standard Deviation|Mean
2687527|NCT01340872|Secondary|Proportion of Subjects That Achieved Hb Concentration Within Normal Range at Week 12 (Full Analysis Set, FAS)|Logistic regression analysis of proportion of subjects that achieved Hb concentration within normal range at Week 12 - end of double-blind phase|Baseline to Week 12 - double-blind phase|FAS|||Participants|||Count of Participants
2687528|NCT01340872|Secondary|Proportion of Subjects That Achieved ≥2 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS)|Logistic regression analysis of proportion of subjects that achieved ≥2 g/dL change from baseline in Hb concentration at Week 12 in the double-blind phase|Baseline to Week 12 - double-blind phase|FAS|||Participants|||Count of Participants
2687529|NCT01340872|Secondary|Proportion of Subjects That Achieved ≥1 g/dL Change From Baseline in Hb Concentration at Week 12 (Full Analysis Set, FAS)|Logistic regression analysis of proportion of subjects that achieved ≥1 g/dL change from baseline in Hb concentration at Week 12 in the double-blind phase|Subjects that achieved ≥1 g/dL change from baseline in Hb concentration at Week 12 - double-blind phase|Full Analysis Set (FAS)|||Participants|||Count of Participants
2687530|NCT01340872|Primary|Change in Haemoglobin (Hb) Concentration From Baseline to Week 12 (Full Analysis Set, FAS)|Primary efficacy endpoint, defined as the change in Hb concentration from Baseline to Week 12. Baseline was defined as the pre-dose Hb concentration measured at the Randomisation Visit (Week 0). Missing Randomisation Hb values were replaced by Screening Hb values, if the randomisation was within the protocol-specified window. Hb concentration (g/dL) was analysed by a central laboratory from blood samples collected at every clinic visit: Screening, Randomisation (Week 0), Weeks 4, 8, 12, 14, 16, 20, 24, 36, 48, 64, Weeks 14 to 64 were open-label. The baseline, absolute concentration and change from baseline in Hb at all post-randomisation visits were listed and summarised by week using descriptive statistics. An analysis of covariance (ANCOVA) was used to analyse the primary endpoint; this included treatment, gender and disease as factors and baseline Hb as a covariate.|Baseline to Week 12 - double-blind phase|Full Analysis Set (FAS)|||g/dL||Standard Deviation|Mean
2687531|NCT01340794|Secondary|Time to Treatment Failure|The time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 5 years.|Up to 5 years from registration|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable.|||months||95% Confidence Interval|Median
2687532|NCT01340794|Secondary|Progression-free Survival Time|Progression-free survival is defined as the time from registration to documentation of disease progression. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. Progression-free survival time will be estimated using the Kaplan-Meier method.|The time from registration to documentation of disease progression or death, whichever occurs first, assessed up to 5 years|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable|||months||95% Confidence Interval|Median
2687533|NCT01340794|Secondary|Overall Survival Time|Overall survival time is defined as the time from registration to death due to any cause and will be estimated using the Kaplan-Meier method.|The time from registration to death due to any cause, assessed up to 5 years|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable|||months||95% Confidence Interval|Median
2687534|NCT01340794|Secondary|Duration of Tumor Response|Defined for all patients whose tumor met the criteria of CR or PR (using the RECIST criteria) as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented.|Up to 5 years|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. None of the 4 patients that initiated treatment with a run-in responded||||||
2687544|NCT01340651|Secondary|Maximum Observed Plasma Concentration (Cmax) of Ruxolitinib 25 mg SR on Day 1|Blood samples were collected prior to and at 0.5, 1, 2, 3, 4, 6, and 9 hours after administration of ruxolitinib 25 mg SR on Day 1 of the study. The concentration of ruxolitinib was determined in plasma samples by a validated LC/MS/MS assay. Standard non-compartmental pharmacokinetic methods were used to analyze the ruxolitinib plasma concentration data using WinNonlin® version 6.0.0 (Pharsight Corporation, Mountain View, CA). Cmax was taken directly from the observed plasma concentration data.|Day 1|Pharmacokinetic evaluable participants: All enrolled participants who received at least 1 dose of study medication and provided at least 1 plasma sample.|||nM||Standard Deviation|Mean
2697196|NCT01263561|Primary|Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication||1 year post surgery||||percentage of participants|||Number
2687535|NCT01340794|Primary|Response Rate (RR) (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1|"Response and progression are evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1) Ninety-five percent confidence intervals for the true response proportion was calculated using the exact binomial test.~Complete Response (CR): All of the following must be true:~Disappearance of all target and non-target lesions.~Each lymph node must have reduction in short axis to <1.0 cm.~Partial Response (PR):~At least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking baseline measures as reference.~Overall Response (OR) was calculated by summing the number of patients with a CR or PR."|Up to 5 years|One of the two patients that initiated treatment with no run-in was found to be ineligible for this endpoint, leaving one patient evaluable for this endpoint in this treatment group. For patient confidentiality, results are not entered for endpoints based on 1 patient measures. All 4 patients that initiated treatment with a run-in were evaluable|||percentage of participants||95% Confidence Interval|Number
2687536|NCT01340768|Secondary|Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event|Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change). Asymptomatic hypoglycemic events were based on self-monitored finger-stick blood glucose level.|Up to 30 days (Day 1 through last day of Ramadan)|All participants as treated population defined as all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
2687537|NCT01340768|Primary|Percentage of Participants With at Least One Symptomatic Hypoglycemic Event|Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example, but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change).|Up to 30 days (Day 1 through last day of Ramadan)|All participants as treated population defined as all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
2687538|NCT01340664|Secondary|Percentage of Patients With HbA1c <7% at Week 18|The table below shows the percentage of patients with HbA1c <7% at Week 18 in each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the percentage.|Week 18|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when Week 18 values were missing. The table includes only patients with both baseline and post baseline values.|||Percentage of Participants|||Number
2687539|NCT01340664|Secondary|Percent Change in Body Weight From Baseline to Week 18|The table below shows the least-squares (LS) mean percent change in body weight from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean percent change.|Day 1 (Baseline) and Week 18|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when Week 18 values were missing. The table includes only patients with both baseline and post baseline values.|||Percent change||Standard Error|Least Squares Mean
2687540|NCT01340664|Secondary|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 18|The table below shows the least-squares (LS) mean change in FPG from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 18|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when Week 18 values were missing. The table includes only patients with both baseline and post baseline values.|||mg/dL||Standard Error|Least Squares Mean
2687541|NCT01340664|Primary|Change in HbA1c From Baseline to Week 18|The table below shows the least-squares (LS) mean change in HbA1c from Baseline to Week 18 for each treatment group. The statistical analyses show the treatment differences (ie, each canagliflozin group minus placebo) in the LS mean change.|Day 1 (Baseline) and Week 18|This analysis used the modified intent-to-treat analysis set (all patients who were randomly assigned to a treatment group and received at least 1 dose of study drug). The last-observation-carried-forward method was applied when Week 18 values were missing. The table includes only patients with both baseline and post baseline values.|||Percent||Standard Error|Least Squares Mean
2687542|NCT01340651|Secondary|Area Under the Plasma Concentration-time Curve (AUC) of Ruxolitinib 25 mg SR on Day 1|Blood samples were collected prior to and at 0.5, 1, 2, 3, 4, 6, and 9 hours after administration of ruxolitinib 25 mg SR on Day 1 of the study. The concentration of ruxolitinib was determined in plasma samples by a validated LC/MS/MS assay. The area under the plasma concentration-time curve (AUC) was derived from the plasma concentrations using a non-compartmental method and computed using the linear trapezoidal rule for increasing concentrations and the log-trapezoidal rule for decreasing concentrations with the software WinNonlin® version 6.0.0 (Pharsight Corporation, Mountain View, CA).|Day 1|Pharmacokinetic evaluable participants: All enrolled participants who received at least 1 dose of study medication and provided at least 1 plasma sample.|||nM*h||Standard Deviation|Mean
2687543|NCT01340651|Secondary|Time to Reach the Maximum Plasma Concentration (Tmax) of Ruxolitinib 25 mg SR on Day 1|Blood samples were collected prior to and at 0.5, 1, 2, 3, 4, 6, and 9 hours after administration of ruxolitinib 25 mg SR on Day 1 of the study. The concentration of ruxolitinib was determined in plasma samples by a validated LC/MS/MS assay. Standard noncompartmental pharmacokinetic methods were used to analyze the ruxolitinib plasma concentration data using WinNonlin® version 6.0.0 (Pharsight Corporation, Mountain View, CA). Tmax was taken directly from the observed plasma concentration data.|Day 1|Pharmacokinetic evaluable participants: All enrolled participants who received at least 1 dose of study medication and provided at least 1 plasma sample.|||h||Full Range|Median
2687590|NCT01340573|Primary|Number of Non-genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 of Study Treatment|Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 of study treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.|Week-24|The study was terminated early due to low enrollment. This analysis was not performed.||||||
2687545|NCT01340651|Secondary|Percentage of Participants With a ≥ 50% Reduction From Baseline in the Total Symptom Score at Week 16|Symptoms of myelofibrosis were assessed using the modified Myelofibrosis Symptom Assessment Form v2.0 diary that was to be completed by participants each night. The 7 symptoms (night sweats, itchiness, abdominal pain, pain under the ribs on left side, feeling of fullness [early satiety], bone/muscle pain, inactivity) were each rated on a scale from 0 (absent) to 10 (worst imaginable). The total symptom score was the sum of 6 of the 7 symptoms (inactivity was not included) and ranged from 0 to 60. A lower score indicated fewer symptoms.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.|||Percentage of participants||95% Confidence Interval|Number
2687546|NCT01340651|Secondary|Change From Baseline in the Total Symptom Score at Week 16|Symptoms of myelofibrosis were assessed using the modified Myelofibrosis Symptom Assessment Form v2.0 diary that was to be completed by participants each night. The 7 symptoms (night sweats, itchiness, abdominal pain, pain under the ribs on left side, feeling of fullness [early satiety], bone/muscle pain, inactivity) were each rated on a scale from 0 (absent) to 10 (worst imaginable). The total symptom score was the sum of 6 of the 7 symptoms (inactivity was not included) and ranged from 0 to 60. A lower score indicated fewer symptoms. A negative change score indicated improvement.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.|||Percentage change||Standard Deviation|Mean
2687547|NCT01340651|Secondary|Percentage of Participants With ≥ 35% Reduction in Spleen Volume at Week 16 From Baseline|Spleen volume was measured by magnetic resonance imaging (or by computed tomography [CT] in applicable participants). Scans were read by a central reader. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.|||Percentage of participants||95% Confidence Interval|Number
2687548|NCT01340651|Secondary|Change From Baseline in Spleen Length at Week 16|Spleen length was measured in centimeters by palpation.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.|||Percentage change||Standard Deviation|Mean
2687549|NCT01340651|Secondary|Change From Baseline in Spleen Volume at Week 16|Spleen volume was measured by magnetic resonance imaging (or by computed tomography [CT] in applicable participants). Scans were read by a central reader. Spleen volume was obtained by outlining the circumference of the organ and determining the volume using the validated technique of least squares.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.|||Percentage change||Standard Deviation|Mean
2687550|NCT01340651|Primary|Overall Response (OR) at Week 16|The investigator graded OR according to the International Working Group for Myelofibrosis Research and Therapy criteria for treatment response. As bone marrow biopsies were not taken after baseline, the best achievable response was clinical improvement which required 1 of the following in the absence of progressive disease (PD): (1) A ≥ 2 g/dL increase in hemoglobin level or (2) either a palpable ≥ 50% reduction of splenomegaly of a spleen ≥ 10 cm at baseline or a spleen palpable at > 5 cm at baseline becoming not palpable. PD required 1 of the following: (1) Progressive splenomegaly defined by the appearance of previously absent splenomegaly that was palpable at > 5 cm below the left costal margin or a ≥ 100% increase in palpable distance for baseline splenomegaly of 5-10 cm or a ≥ 50% increase in palpable distance for baseline splenomegaly of > 10 cm or (2) an increase in peripheral blood blast percentage to ≥ 20% that lasted for ≥ 8 weeks. Stable disease: None of the above.|Baseline to Week 16|Intent-to-treat population: All enrolled participants.|||Percentage of participants|||Number
2687551|NCT01340651|Primary|Percentage of Participants With at Least 1 Adverse Event From Baseline Through Week 16||Baseline to Week 16|Safety population: All enrolled participants who took at least 1 dose of study drug.|||Percentage of participants|||Number
2687552|NCT01340625|Primary|AUC0-inf of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 60 hour period.|34 out of 36 subjects completed the study. Subjects 13 & 35 were excluded from the statistical analysis for Ethinyl Estradiol due to pre-dose concentrations greater than 5% of Cmax; therefore analysis included 32 data sets.|||pg*h/mL||Standard Deviation|Mean
2687553|NCT01340625|Primary|AUC0-t of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 60 hour period.|34 out of 36 subjects completed the study. Subjects 13 & 35 were excluded from the statistical analysis for Ethinyl Estradiol due to pre-dose concentrations greater than 5% of Cmax; therefore analysis included 32 data sets.|||pg*h/mL||Standard Deviation|Mean
2687554|NCT01340625|Primary|Cmax of Ethinyl Estradiol|Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 60 hour period.|34 out of 36 subjects completed the study. Subjects 13 & 35 were excluded from the statistical analysis for Ethinyl Estradiol due to pre-dose concentrations greater than 5% of Cmax; therefore analysis included 32 data sets.|||pg/mL||Standard Deviation|Mean
2687555|NCT01340625|Primary|AUC0-inf of Norethindrone|Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2687556|NCT01340625|Primary|AUC0-t of Norethindrone|Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.|||ng*h/mL||Standard Deviation|Mean
2687557|NCT01340625|Primary|Cmax of Norethindrone|Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma).|Blood samples collected over a 60 hour period.|All participants that completed the study had their samples analyzed.|||ng/mL||Standard Deviation|Mean
2687572|NCT01340586|Primary|Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for BMS-730823|Area under the plasma concentration-time curve from 2 hours to 6 hours (AUC(2-6) for BMS-730823 was measured in participants with ESRD during dialysis in Period 1 only. Geometric Means were reported in nanogram hours per milliliter (ng*hr/mL) and were determined from blood samples both entering and exiting the dialyzer.|2 to 6 hours post-dose|All participants with ESRD maintained with hemodialysis|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2697197|NCT01263561|Primary|Intraocular Pressure||1 year post surgery||||mmHg||Standard Deviation|Mean
2687558|NCT01340586|Other Pre-specified|Number of Participants Who Died or Experienced Serious Adverse Events (SAEs) or Adverse Events Leading to Discontinuation|"The number of participants who died or experienced SAEs or AEs leading to discontinuation was reported for each arm.~AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling."|From Day 1 to 30 days post study discontinuation|All treated participants|||participants|||Number
2687559|NCT01340586|Other Pre-specified|Number of Participants With Laboratory Marked Abnormalities|"ULN=Upper Limit of Normal, LLN=Lower Limit of Normal, Pre-Rx= Baseline value. BUN=Blood Urea Nitrogen (mmol/L=millimoles per Liter): High if BUN > 1.1*ULN (if Pre-Rx>ULN: >1.25*Pre-Rx).~Platelet count (*10^9 cell/L): Low if Platelet Count < 0.85*LLN (if Pre-Rx<LLN: <0.85*Pre-Rx).~Creatine (umol/L=micromoles per Liter): High if Creatine > 1.5*ULN (if Pre-Rx>ULN: >1.33*Pre-Rx).~Calcium, Total (mmol/L): High if Calcium > 1.5*ULN (if Pre-Rx>ULN: >1.33*Pre-Rx).~Potassium, serum (mmol/L): High if Potassium > 1.1*ULN (if Pre-Rx>ULN: >1.1*Pre-Rx; if Pre-Rx<LLN: >ULN).~Phosphorus, Inorganic (mmol/L): Low if Phosphate < 0.85*LLN (if Pre-Rx>ULN: <LLN).~Lactate dehydrogenase (U/L=Units per Liter): High if Lactate Dehydrogenase > 1.25*ULN (if Pre-Rx>ULN: >1.5*Pre-Rx)."|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||participants|||Number
2687560|NCT01340586|Secondary|Mean Peak Anti-FXa Activity Following a Single Oral Dose of 5 mg Apixaban|Anti-FXa activity was assessed from an activity-time profile for doses both before and after hemodialysis. Maximal means were reported in International Units per milliliter (IU/mL).|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||IU/mL||Standard Deviation|Mean
2687561|NCT01340586|Secondary|Mean Maximum Percent Change From Baseline Activated Partial Thromboplastin Time (aPTT) Following a Single Oral Dose of 5 mg Apixaban|The mean maximum percent change in Activated Partial Thromboplastin Time (aPTT) from baseline was reported for all treated participants. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing.|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||maximum percent change from baseline||Standard Deviation|Mean
2687562|NCT01340586|Secondary|Mean Maximum Percent Change From Baseline Prothrombin Time (PT) Following a Single 5 mg Oral Dose of Apixaban|The mean maximum percent change in Prothrombin Time (PT) from baseline was reported for all treated participants. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing.|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||maximum percent change from baseline||Standard Deviation|Mean
2687563|NCT01340586|Secondary|Mean Maximum Percent Change From Baseline International Normalized Ratio (INR) Following a Single 5 mg Oral Dose of Apixaban|The mean maximum percent change in baseline for INR was reported for each arm. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing.|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||maximum percent change from baseline||Standard Deviation|Mean
2687564|NCT01340586|Primary|Percentage of BMS-730823 Extracted During Hemodialysis|The percentage of BMS-730823 extracted during hemodialysis (extraction ratio) was calculated using the formula [plasma AUC(2-6)exiting - AUC(2-6)entering] / [AUC(2-6) entering] and converted to a percentage. The extraction ratio was measured in period 1 only, and was reported as a percentage.|2 to 6 hours post-dose|All treated participants with ESRD maintained with hemodialysis|||percentage of BMS-730823 extracted||Standard Deviation|Mean
2687565|NCT01340586|Primary|Percentage of Apixaban Extracted During Hemodialysis|The percentage of apixaban extracted during hemodialysis (extraction ratio) was calculated using the formula [plasma AUC(2-6) exiting - AUC(2-6) entering] / [AUC(2-6) entering] and converted to a percentage. The extraction ratio was measured in period 1 only, and was reported as a percentage.|2 to 6 hours post-dose|All treated participants with ESRD maintained with hemodialysis|||percentage of apixaban extracted||Standard Deviation|Mean
2687566|NCT01340586|Primary|Mean Hemodialysis Clearance (CLD) of BMS-730823|Hemodialysis clearance (CLD) was calculated by dividing the cumulative amount of BMS-730823 excreted in dialysate by the respective cumulative plasma AUC over the same dialysate collection interval (AUC(2-6) entering). CLD measurements occurred only in period 1. Geometric means were reported in milliliters per minute (mL/min).|2 to 6 hours post-dose|All participants with ESRD maintained with hemodialysis|||mL/min||Standard Deviation|Mean
2687567|NCT01340586|Primary|Mean Hemodialysis Clearance (CLD) of Apixaban|Hemodialysis clearance (CLD) was calculated by dividing the cumulative amount of apixaban excreted in dialysate by the respective cumulative plasma AUC over the same dialysate collection interval (AUC(2-6) entering). CLD measurements occurred only in period 1. Geometric means were reported in milliliters per minute (mL/min).|2 to 6 hours post-dose|All treated participants with ESRD maintained with hemodialysis|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2687568|NCT01340586|Primary|Mean Renal Clearance (CLR) of BMS-730823|Renal clearance (CLR) was calculated by dividing the cumulative amount of BMS-730823 excreted in urine by the respective cumulative plasma AUC over the same urine collection interval. Geometric means were reported in milliliters per minute (mL/min).|24 hours pre-dose to 72 hours post-dose|All treated participants|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2687569|NCT01340586|Primary|Mean Renal Clearance (CLR) of Apixaban|Renal clearance (CLR) was calculated by dividing the cumulative amount of apixaban excreted in urine by the respective cumulative plasma AUC over the same urine collection interval. Geometric means were reported in milliliters per minute (mL/min).|24 hours pre-dose to 72 hours post-dose|All treated participants|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2687570|NCT01340586|Primary|Mean Percent Dose of Apixaban Recovered in Dialysate (%DR)|Percent dose of Apixaban recovered in dialysate (%DR) was calculated by dividing the cumulative amount of apixaban excreted in each dialysate collection over 2-6 hours (DR(2-6)) by the apixaban dose. %DR was recorded only in period 1.|2 to 6 hours post-dose|All treated participants with ESRD maintained with hemodialysis|||percent of dose recovered in dialysate||Standard Deviation|Mean
2687571|NCT01340586|Primary|Mean Percent Dose of Apixaban Recovered in Urine (%UR)|The percent dose recovered in urine was calculated by dividing the cumulative amount of unchanged apixaban excreted in urine from the time of dose up to 72 hours post-dose by the apixaban dose administered.|24 hours pre-dose to 72 hours post-dose|All treated participants|||percent of dose recovered in urine||Standard Deviation|Mean
2687573|NCT01340586|Primary|Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for Apixaban|Area under the plasma concentration-time curve from 2 hours to 6 hours (AUC(2-6) for Apixaban was measured in participants with ESRD during dialysis in Period 1 only. Geometric Means were reported in nanogram hours per milliliter (ng*hr/mL) and were determined from blood samples both entering and exiting the dialyzer.|2 to 6 hours post-dose|All participants with ESRD maintained with hemodialysis|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2687574|NCT01340586|Primary|Median Time of Maximum Observed Plasma Concentration (Tmax) of Metabolite BMS-730823|Time of maximum observed plasma concentration (Tmax) for BMS-730823 was derived from plasma concentrations versus time data. Medians were reported in hours.|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||hours||Full Range|Median
2687575|NCT01340586|Primary|Median Time of Maximum Observed Plasma Concentration (Tmax) of a Single 5 mg Oral Dose of Apixaban|Time of maximum observed plasma concentration (Tmax) for apixaban was derived from plasma concentrations versus time data. Medians were reported in hours.|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||hours||Full Range|Median
2687576|NCT01340586|Primary|Mean Plasma Terminal Half-life (T-Half) of BMS-730823|Mean plasma terminal half-life (T-Half) for BMS-730823 was derived from plasma concentrations versus time data.|24 hours pre-dose to 72 hours post-dose|All treated participants with ESRD maintained with hemodialysis|||hours||Standard Deviation|Mean
2687577|NCT01340586|Primary|Mean Plasma Terminal Half-life (T-Half) of Single 5mg Oral Dose of Apixaban|Plasma terminal half-life (T-Half) for apixaban was derived from plasma concentrations versus time data. Means were reported in hours.|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||hours||Standard Deviation|Mean
2687578|NCT01340586|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-730823|The area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|24 hours pre-dose to 72 hours post-dose|All treated participants|||ng*h/mL||Standard Deviation|Mean
2687579|NCT01340586|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Single 5mg Oral Dose of Apixaban|The area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2687580|NCT01340586|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Metabolite BMS-730823|Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2687581|NCT01340586|Primary|Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Single 5mg Oral Dose of Apixaban|Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).|24 hours pre-dose to 72 hours post-dose|All treated participants|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2687582|NCT01340586|Primary|Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Metabolite BMS-730823|Maximum observed plasma concentration (Cmax) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanograms per milliliter (ng/mL).|From 24 hours pre-dose to 72 hours post-dose|All treated participants|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2687583|NCT01340586|Primary|Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Single 5mg Oral Dose of Apixaban|Maximum observed plasma concentration (Cmax) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanograms per milliliter (ng/mL).|24 hours pre-dose to 72 hours post-dose|All treated participants|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2687584|NCT01340573|Secondary|Participants' Overall Rating of Satisfaction and the Use of Training Materials for the Pegintron Pen, as Provided in a Study Questionnaire|Participants will complete a single questionnaire during the first follow-up visit (Week 12). The questionnaire will measure the participant's satisfaction and the use of training materials for the PegIntron Pen during the course of study therapy, as measured by the participant using a 1- 5 score system provided in the questionnaire.|Week 12|The study was terminated early due to low enrollment. This analysis was not performed.||||||
2687585|NCT01340573|Secondary|Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up||Week-24 follow-up|The study was terminated early due to low enrollment. This analysis was not performed.||||||
2687586|NCT01340573|Secondary|Number of Genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-48 of Study Treatment||Week-48|The study was terminated early due to low enrollment. This analysis was not performed.||||||
2687587|NCT01340573|Secondary|Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 Follow-up||Week-24 follow-up|The study was terminated early due to low enrollment. This analysis was not performed.||||||
2687588|NCT01340573|Secondary|Number of Non-genotype-1 Participants Who Have Achieved Sustained Virologic Response (SVR) at Week-24 of Study Treatment|Sustained virologic response (SVR) is the absence of detectable HCV RNA in serum after end of treatment.|Week-24|The study was terminated early due to low enrollment. This analysis was not performed.||||||
2687589|NCT01340573|Primary|Number of Non-genotype 1 Participants Who Experienced Serious Adverse Events (SAE) on Week-24 Follow-up|Collection of all safety reports (serious adverse events) from Non-genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.|Week-24 follow-up|The study was terminated early due to low enrollment. This analysis was not performed.||||||
2692195|NCT01303939|Primary|Absolute Brain Volume (Size)|Absolute volume (size) of inferior occipital gyrus L (a location in the brain structure) is measured in cubic millimeters (mm3).|2 hours||||cubic millimeters (mm3)||Standard Deviation|Mean
2687591|NCT01340573|Primary|Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-24 Follow-up|Collection of all safety reports (serious adverse events) from genotype-1 population at week-24 non-treatment follow-up, from participants on pegylated interferon (PegIntron) pen plus ribavirin.|Week-24 follow-up|The study was terminated early due to low enrollment. This analysis was not performed.||||||
2687592|NCT01340573|Primary|Number of Genotype-1 Participants Who Experienced Serious Adverse Events (SAE) at Week-48 of Study Treatment|Collection of all safety reports (serious adverse events) from genotype-1 population at week-48 of treatment, from participants on pegylated interferon (PegIntron) pen plus ribavirin.|Week-48|The study was terminated early due to low enrollment. This analysis was not performed.||||||
2687593|NCT01340495|Secondary|Progression Free Survival|Progression-free survival is defined as the duration from the start of radiation to the date of objective disease progression or death due to any cause, whichever is earlier. Disease progression is defined as the appearance of one or more new lesions.|from the start of treatment until the time of disease progression, up to 5 years||2023-01-31|01/2023||||
2687594|NCT01340495|Secondary|The Number of Participants With Early Signs of Cardiac Effects From Radiation Therapy|The number of participant that had early signs of cardiac effects from radiation therapy as assessed using a Strain Echo-cardiogram. The data from the Echo-cardiogram was evaluated for signs of negative impacts to cardiac function as determined by the treating physician. Parameters considered in the evaluation of the echo-cardiogram by the physician included myocardial velocity, strain, strain rate, and torsion. Blood-based cardiac bio-markers pro-BNP and ultra-sensitive troponin-I were also assessed. Either a clinically meaningful change in the strain echo-cardiogram parameters or clinically meaningful elevation of the bio-markers was sufficient to be considered to have early signs of cardiac effects.|Baseline and then 4 and 8 weeks post treatment|One participant withdrew from the trial before the start of treatment and was not included in the analysis population.|||Participants|||Count of Participants
2687595|NCT01340495|Secondary|The Number of Participants That Needed Unplanned Additional Surgery for Breast Reconstruction||From the start of treatment until 5 years post treatment||2023-01-31|01/2023||||
2687596|NCT01340495|Secondary|Acute and Late Toxicity of Breast Reconstruction Following Proton Radiation|Combined summary of the acute (within 3 months of completing treatment) and late (3 months to 5 years after completion of treatment) toxicities experienced by participants thought to be related to breast reconstruction surgery following proton radiation treatment. Toxicities are assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).|From the start of treatment until 5 years post treatment||2023-01-31|01/2023||||
2687597|NCT01340495|Secondary|To Evaluate Cosmetic Outcome and Patient Satisfaction With Cosmetic Outcome||From the start of treatment until 5 years post treatment||2023-01-31|01/2023||||
2687598|NCT01340495|Secondary|Summary of Late Skin Toxicity|A summary of the late skin toxicities experienced by participants. The number of participants effected is shown for each toxicity experienced. Skin toxicities were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).|From 3 months after the end of treatment up to 5 years||2023-01-31|01/2023||||
2687599|NCT01340495|Secondary|Rate and Severity of Radiation Pneumonitis|"The number of participants that experienced radiation pneumonitis within three months of the end of treatment. The participants that experienced radiation pneumonitis are grouped by grade. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).~Grade 1: Mild~Grade 2: Moderate~Grade 3: Severe~Grade 4: Life-Threatening~Grade 5: Fatal"|From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.|One participant withdrew from the trial before the start of treatment and was not included in the analysis population.|||Participants|||Count of Participants
2687600|NCT01340495|Secondary|The Number of Participants With Acute Skin Toxicities|Summary of the number of participants with any grade acute skin toxicities. Acute skin toxicity was assessed from the start of treatment until 90 days after the end of treatment. Skin toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).|From the start of treatment until 3 months after the end of treatment|One participant withdrew from the trial before the start of treatment and was not included in the analysis population.|||Participants|||Count of Participants
2687601|NCT01340495|Primary|Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event|To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy based on the occurrence of grade 3 or > radiation pneumonitis or any grade 4 adverse event within 3 months after the completion of radiation treatment.|From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks|One participant withdrew from the trial before the start of treatment and was not included in the analysis population.|||Participants|||Count of Participants
2687602|NCT01340300|Other Pre-specified|Changes in Body Composition by Treatment Arm - Waist to Hip Ratio|Negative least square means indicate a decrease at 3 month comparing to baseline value.|0 and 3 months (change between 0 and 3 months)|2 patients are excluded for missing baseline measurements.|||ratio||Standard Error|Least Squares Mean
2687603|NCT01340300|Other Pre-specified|Changes in Body Composition by Treatment Arm - BMI|Negative least square means indicate a decrease at 3 month comparing to baseline value.|0 and 3 months (change between 0 and 3 months)|2 patients are excluded for missing baseline measurements.|||kg/m^2||Standard Error|Least Squares Mean
2687604|NCT01340300|Other Pre-specified|Changes in Body Composition by Treatment Arm - Weight|Negative least square means indicate a decrease at 3 month comparing to baseline value.|0 and 3 months (change between 0 and 3 months)|2 patients are excluded for missing baseline measurements.|||kg||Standard Error|Least Squares Mean
2687605|NCT01340300|Secondary|Change in Fasting Glucose Level|Determine whether supervised exercise training alone and metformin, either alone or in combination can decrease fasting Glucose level from baseline to 3 months in patients who completed standard therapy for stage I-III colorectal or breast cancer. Fasting Glucose levels in blood will be drawn at baseline, 3 months and 6 months. Negative least square means indicate a decrease at 3 month comparing to baseline value.|0 and 3 months (change between 0 and 3 months)|11 patients are excluded for missing baseline blood samples.|||mg/dL||Standard Error|Least Squares Mean
2687712|NCT01339897|Primary|Safety of Escalating Multiple Doses of N6022 in Healthy Subjects|Safety variables (adverse events, vital signs, physical examination, telemetry, 12-lead ECG, infusion site reactions, O2 saturation, and clinical laboratory assessments)|Over 7 days|Any subject that received any dose of N6022 or placebo.|||participants|||Number
2687606|NCT01340300|Secondary|Changes in Other Insulin-Related Biomarkers|Markers related to insulin and insulin-like growth factors (including insulin-like growth factor 1 [IGF-1], IGF binding protein-1 [IGFBP-1], IGF binding protein-3 [IGFBP-3], leptin) will be measured by a blood draw at baseline, 3 months and 6 months. Negative least square means indicate a decrease at 3 month comparing to baseline value.|0 and 3 months (change between 0 and 3 months)|11 patients are excluded for missing baseline blood samples.|||ng/mL||Standard Error|Least Squares Mean
2687607|NCT01340300|Primary|Change in Fasting Insulin Level|Determine whether supervised exercise training alone and metformin, either alone or in combination can decrease fasting insulin level from baseline to 3 months in patients who completed standard therapy for stage I-III colorectal or breast cancer. Fasting insulin levels in blood will be drawn at baseline, 3 months and 6 months. Negative least square means indicate a decrease at 3 month comparing to baseline value.|0 and 3 months (change between 0 and 3 months)|11 patients are excluded for missing baseline blood samples.|||mU/L||Standard Error|Least Squares Mean
2687608|NCT01340209|Secondary|Weekly Mean Score of Asthma Symptoms During the Day (Response)|"Response of weekly mean score of asthma symptoms during the day at week 52. Response was defined as change from baseline.~5-point verbal rating scale, with answer 1 representing no impairment at all and answer 5 representing the greatest impairment."|baseline and week 52|Full analysis set|||Scores on a scale||Standard Deviation|Mean
2687609|NCT01340209|Secondary|Weekly Mean Score of Asthma Symptoms in the Morning (Response)|"Response of weekly mean score of asthma symptoms in the morning at week 52. Response was defined as change from baseline.~5-point verbal rating scale, with answer 1 representing no impairment at all and answer 5 representing the greatest impairment."|baseline and week 52|Full analysis set|||Scores on a scale||Standard Deviation|Mean
2687610|NCT01340209|Secondary|Weekly Mean Number of Puffs of Rescue Medication During the Whole Day (Response)|Response of weekly mean number of puffs of rescue medication during the whole day at week 52. Response was defined as change from baseline.|baseline and week 52|Full analysis set|||Puffs||Standard Deviation|Mean
2687611|NCT01340209|Secondary|Weekly Mean PEF Variability Response|"Weekly mean PEF variability response was defined as change from baseline at week 52.~The PEF variability is the absolute difference between morning and evening PEF value, divided by their mean, expressed as a percent. Response was defined as change from baseline."|baseline and week 52|Full analysis set|||percentage||Standard Error|Least Squares Mean
2687612|NCT01340209|Secondary|Weekly Mean PEFpm Response|Weekly mean PEFpm response was defined as change from baseline at week 52|baseline and week 52|Full analysis set|||L/min||Standard Error|Least Squares Mean
2687613|NCT01340209|Secondary|Weekly Mean PEFam Response|Weekly mean PEFam response was defined as change from baseline at week 52|baseline and week 52|Full analysis set|||L/min||Standard Error|Least Squares Mean
2687614|NCT01340209|Secondary|Trough PEF Response|Trough PEF response was defined as change from baseline at week 52|baseline and week 52|Full analysis set|||L/min||Standard Error|Least Squares Mean
2687615|NCT01340209|Secondary|Trough FVC Response|Trough FVC response was defined as change from baseline at week 52|baseline and week 52|Full analysis set|||Liter||Standard Error|Least Squares Mean
2687616|NCT01340209|Secondary|Trough FEV1 Response|Trough FEV1 response was defined as change from baseline at week 52|baseline and week 52|Full analysis set: all patients of the treated set for which baseline and at least 1 post-baseline efficacy measurement were available|||Liter||Standard Error|Least Squares Mean
2687617|NCT01340209|Primary|Number of Patients With Drug-related Adverse Events|The primary endpoint is the number of patients with drug-related adverse events|after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409|Treated set: all randomised patients who received at least 1 dose of study medication|||participants|||Number
2687618|NCT01340196|Secondary|Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Safety Laboratory Tests and 12-lead ECG|"Clinical relevant abnormalities for physical examination, vital signs, safety laboratory tests and 12-lead ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.~Preferred term of relevant AE: Presyncope"|From drug administration up to 32 days.|All subjects who were dispensed study medication and were documented to have taken at least one dose of study drug were included in the safety evaluation (treated set).|||participants|||Number
2687619|NCT01340196|Secondary|Number of Patients With Drug Related Adverse Events During the Trial|Outcome data are the numbers of subjects with investigator defined drug-related AEs|From drug administration up to 32 days.|All subjects who were dispensed study medication and were documented to have taken at least one dose of study drug were included in the safety evaluation (treated set).|||participants|||Number
2687620|NCT01340196|Primary|Steady-state Pharmacokinetics of C12hr of Faldaprevir on Day 15 and on Day 22|Measured concentration of the analyte in plasma at 12 h (C12hr) after dosing, at steady state.|168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2687621|NCT01340196|Primary|Steady-state Pharmacokinetics of Cmax of Faldaprevir on Day 15 and Day 22|Maximum measured concentration of analyte in plasma (Cmax), at steady state.|168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2687653|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.|Baseline and Weeks 2, 4, 8 and 12|"Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by n)."|||incontinence episodes||Standard Error|Least Squares Mean
2687622|NCT01340196|Primary|Steady-state Pharmacokinetics of AUC0-12 of Faldaprevir on Day 15 and on Day 22|Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-12 hours, at steady state.|168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15 and 144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00 hours on day 22|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2687623|NCT01340196|Primary|Steady-state Pharmacokinetics of C24hr of Tenofovir on Day 7 and on Day 15|Measured concentration of the analyte in plasma at 24 h (C24hr) after dosing, at steady state.|144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2687624|NCT01340196|Primary|Steady-state Pharmacokinetics of Cmax of Tenofovir on Day 7 and on Day 15|Maximum measured concentration of analyte in plasma (Cmax), at steady state.|144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00. 192:00 hours on day 15|All participants from the pharmacokinetic analysis set (PK set), including all subjects in the treated set who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2687625|NCT01340196|Primary|Steady-state Pharmacokinetics of AUC0-24 of Tenofovir on Day 7 and on Day 15|Area under the concentration-time curve (AUC) of the analyte in plasma over the time interval 0-24 hours, at steady state.|144:00, 144:30, 145:00, 145:30, 146:00, 147:00, 148:00, 150:00, 152:00, 156:00, 168:00 hours on day 7 and 168:00, 168:30, 169:00, 169:30, 170:00, 172:00, 174:00, 176:00, 178:00, 180:00, 192:00 hours on day 15|All participants from the pharmacokinetic analysis set (PK set), including all subjects who were documented to have taken at least one dose of trial medication (treated set) who provided evaluable data for at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2687626|NCT01340144|Primary|Evaluate for the Incidence of Patellar Crepitus Requiring Non-operative vs. Operative Treatment of Both the Study and Control Groups at a Minimum of 12 Months Following the TKA (Total Knee Arthroplasty) Procedure in Each Subject.|The incidence of patellar crepitus and clunk will be statistically compared between the study (PFC Sigma HP PS TKA) and control (PFC Sigma PS TKA groups). Based on a strength analysis to determine a theoretical reduction in the incidence of patellar crepitus from 5% to 2%, a study group of 625 subjects in both the control and study ggroups will be required. Each group will also be statistically analyzed using the following variables: overall crepitus incidence, incidence of crepitus requiring only non-operative treatment vs. those requiring operative treatment to manage this complication.|Two years after TKA (Total Knee Arthroplasty) procedure||||participants|||Number
2687627|NCT01340066|Primary|Percentage of Participants With a Decrease in Leakage Events of 30% or More.|Incontinence events were recorded on a daily diary. Leaks were scored and tabulated for a daily score. These values were utilized to come up with total of leakage events during the double-blind treatment period.|Change from baseline after 4 weeks of treatment.||||Percentage of participants|||Number
2687628|NCT01340053|Secondary|Spontaneous Bowel Movement (SBM) Frequency Change From Baseline||baseline and week 4||||change in number of bowel movements||Standard Deviation|Mean
2687629|NCT01340053|Primary|Complete Spontaneous Bowel Movement (CSBM) Frequency Change From Baseline|"Patients complete a phone diary daily. They are asked how many bowel movements have you had today? they are then asked for each spontaneous bowel movement (unaided with laxative use) wether there was its was a complete evacuation. if it was then it is a complete spontaneous bowel movement. All CSBMs are added and adjusted for a mean compete sponteneous bowel movement."|Baseline and Week 4|All patients randomized who received at least one dose of drug|||number of bowel movements/week||Standard Deviation|Mean
2687630|NCT01340027|Secondary|Change From Baseline to End of Treatment in Treatment Satisfaction on Visual Analog Scale (TS-VAS)|The TS-VAS is a visual analog scale (VAS) that asks patients to rate their satisfaction with treatment by placing a vertical mark on a 10 cm line where the endpoints are labeled 'No, not at all' on the left (=0) to 'Yes, completely satisfied' on the right (=10). A positive change from Baseline indicates improvement.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||units on a scale||Standard Error|Least Squares Mean
2687631|NCT01340027|Secondary|Change From Baseline to End of Treatment in Work Productivity and Activity Impairment (WPAI)|This 6-item assessment measures productivity losses during the past 7 days and includes measures on work time missed due to health, impairment while working due to health (the participant's assessment of the degree to which health affected their productivity while working), overall work impairment due to health (takes into account both hours missed due to health and the participant's assessment of the degree to which health affected their productivity while working) and activity impairment due to health (the degree in which health problems affected their ability to do regular daily activities). Scores for each measure are expressed from 0 to 100 with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicates improvement.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.|||units on a scale||Standard Deviation|Mean
2687632|NCT01340027|Secondary|Change From Baseline to End of Treatment in European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)|The EQ-5D is an international, standardized, generic instrument for describing and evaluating health status. Health status is assessed by patients evaluating their health on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'Worst imaginable health state' (=0) and 'Best imaginable health state' (=100). On the EQ-5D VAS, a positive change from baseline indicates improvement.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||units on a scale||Standard Deviation|Mean
2687633|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I am not anxious or depressed; I am moderately anxious or depressed; I am extremely anxious or depressed. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||participants|||Number
2687634|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no pain or discomfort; I have moderate pain or discomfort; I have extreme pain or discomfort. In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of participants in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||participants|||Number
2687635|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score|"The EQ-5D is a standardized, nondisease-specific instrument for describing health status. Participants were asked which statement best describes their health state with regard to usual activities (work, study or leisure): I have no problems performing my usual activities; I have some problems performing my usual activities; I am unable to perform my usual activities.~In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||participants|||Number
2687636|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems with self-care; I have some problems washing or dressing myself; I am unable to wash or dress myself.~In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||participants|||Number
2687637|NCT01340027|Secondary|Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score|"The EQ-5D is an international, standardized, nondisease-specific (i.e., generic) instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state:~I have no problems in walking about; I have some problems in walking about; I am confined to bed.~In the table below, each row title lists Baseline health status first followed by End of Treatment health status and reports the number of patients in that category."|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||participants|||Number
2687638|NCT01340027|Secondary|Percentage of Participants With a Health-related Quality of Life Total Score Response|Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. HRQL response is defined as improvement (decrease) of at least 10 points from Baseline.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||percentage of participants|||Number
2687639|NCT01340027|Secondary|Change From Baseline to End of Treatment in Health-related Quality of Life (HRQL) Total Score|Health-related quality of life was assessed by the HRQL subscales (coping, concern, sleep and social interaction) of the overactive bladder questionnaire (OABq). The HRQL total score was calculated by adding the 4 HRQL subscale scores, and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from Baseline in HRQL score indicates improvements.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||units on a scale||Standard Error|Least Squares Mean
2687640|NCT01340027|Secondary|Percentage of Participants With a Symptom Bother Response|Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. Symptom bother response is defined as improvement (decrease) of at least 10 points from Baseline.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||percentage of participants|||Number
2687641|NCT01340027|Secondary|Change From Baseline to End of Treatment in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)|Overactive bladder symptoms were assessed using the symptom bother scale of the overactive bladder questionnaire. The symptom bother scale consists of 8 questions answered by the participant on a scale from 1-6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 to 100, with 100 indicating worst severity. A negative change from Baseline in symptom bother score indicates improvements.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used|||units on a scale||Standard Error|Least Squares Mean
2687642|NCT01340027|Secondary|Percentage of Participants With Deterioration in PPBC|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Deterioration was defined as at least a 1 point increase from Baseline in PPBC score.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.|||percentage of participants|||Number
2707421|NCT01191242|Primary|Total 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidene (EDDP) Peak Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
2687643|NCT01340027|Secondary|Percentage of Participants With Major Improvement in PPBC|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Major improvement was defined as at least a 2-point improvement (decrease) from Baseline in PPBC score.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.|||percentage of participants|||Number
2687644|NCT01340027|Secondary|Percentage of Participants With Improvement in PPBC|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. Improvement was defined as at least a 1-point improvement (decrease) from Baseline in PPBC score.|Baseline and Week 12|Full analysis set participants with available Baseline and post-baseline data; LOCF imputation was used.|||percentage of participants|||Number
2687645|NCT01340027|Secondary|Change From Baseline to End of Treatment in Patient Perception of Bladder Condition (PPBC)|The PPBC scale is a global assessment tool that asks patients to rate their impression of their current bladder condition on a 6-point scale from 1: 'Does not cause me any problems at all'; 2: 'Causes me some very minor problems'; 3: 'Causes me some minor problems'; 4: 'Causes me (some) moderate problems'; 5: 'Causes me severe problems' and 6: 'Causes me many severe problems'. A negative change from Baseline score indicates improvement.|Baseline and Week 12|Full Analysis Set participants with available Baseline and post-baseline data; LOCF imputation was used|||units on a scale||Standard Error|Least Squares Mean
2687646|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Nocturia Episodes Per 24-Hours|Nocturia is defined as waking at night one or more times to void. The average number of times a participant urinated (excluding incontinence only episodes) during sleeping time per day was derived from the 3-day micturition diary.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set participants who had at least one nocturia episode at baseline, and including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."|||nocturia episodes||Standard Error|Least Squares Mean
2687647|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Pads Used Per 24 Hours|The average number of times a participant recorded a new pad used per day during the 3-day micturition diary period.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set participants who had at least one use of pad at baseline, and including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."|||pads||Standard Error|Least Squares Mean
2687648|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Level of Urgency|Average of participants' ratings on the degree of urgency associated with each micturition and/or incontinence episode recorded in the 3-day micturition diary according to the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."|||units on a scale||Standard Error|Least Squares Mean
2687649|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours|The average number of urgency episodes (the sudden, compelling desire to pass urine, which is difficult to defer), derived from urgency episodes classified by the participant in the 3-day micturition diary as grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0: No urgency; 1: Mild urgency; 2: Moderate urgency, could delay voiding a short while; 3: Severe urgency, could not delay voiding; 4: Urge incontinence, leaked before arriving to the toilet.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."|||urgency episodes||Standard Error|Least Squares Mean
2687650|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours|Urgency incontinence is the involuntary leakage of urine accompanied by or immediately preceded by urgency, and was derived from the number of incontinence episodes classified by the participant in a 3-day micturition diary as Grade 3 or 4 on the Patient Perception of Intensity of Urgency Scale: 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could postpone voiding a short while; 3 = Severe urgency, could not postpone voiding; 4 = Urge incontinence, leaked before arriving to the toilet.|Baseline and Weeks 2, 4, 8 and 12|"Full Analysis Set-Incontinence participants who had at least 1 urgency (grade 3 or 4) incontinence episode at Baseline, including participants with available data at Baseline and each post-baseline visit (indicated by n). LOCF was used for the End of Treatment (EOT) analysis."|||urgency incontinence episodes||Standard Error|Least Squares Mean
2687651|NCT01340027|Secondary|Percentage of Participants With 50% Reduction in Incontinence Episodes|The percentage of participants with at least a 50% decrease from Baseline in mean number of incontinence episodes per 24 hours during the 3 days prior to each clinic visit derived from the participant's micturition diary.|Baseline and Weeks 2, 4, 8 and 12|"Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by n); LOCF imputation was used for the End of Treatment (EOT) analysis."|||percentage of participants|||Number
2687652|NCT01340027|Secondary|Percentage of Participants With Zero Incontinence Episodes Post-baseline|The percentage of participants with no incontinence episodes for the 3 days prior to each clinic visit derived from the micturition diary recorded by the participant.|Weeks 2, 4, 8 and 12|"Full Analysis Set-Incontinence including participants with available data at Baseline and each post-baseline visit (indicated by n); LOCF imputation was used for the End of Treatment (EOT) analysis."|||percentage of participants|||Number
2687704|NCT01339910|Secondary|Percentage of Participants With Treatment-related Mortality|Treatment-related mortality is defined as death without a previous relapse of the primary disease.|18 months post-randomization||||percentage||95% Confidence Interval|Number
2687705|NCT01339910|Secondary|Percentage of Participants With Disease Relapse|Disease Relapse is defined as relapse of the primary disease.|18 months post-randomization||||percentage||95% Confidence Interval|Number
2687654|NCT01340027|Secondary|Percentage of Participants With a Micturition Response|A responder is defined as a participant with at most 8 micturitions per 24 hours post-baseline and a negative change (i.e. an improvement) from Baseline.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set participants with at least 8 micturitions per 24 hours at Baseline and including participants with available data at Baseline and each post-baseline visit (indicated by n); LOCF imputation was used for the End of Treatment (EOT) analysis."|||percentage of participants|||Number
2687655|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and each post-baseline clinic visit.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n)."|||micturitions||Standard Error|Least Squares Mean
2687656|NCT01340027|Secondary|Change From Baseline to Each Visit in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and each post-baseline clinic visit.|Baseline and Weeks 2, 4, 8 and 12|"Full analysis set including participants with available data at Baseline and each post-baseline visit (indicated by n).."|||mL||Standard Error|Least Squares Mean
2687657|NCT01340027|Secondary|Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours|The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|The Full Analysis Set-Incontinence comprised participants in the FAS who reported at least 1 incontinence episode in the baseline diary. LOCF was used.|||incontinence episodes||Standard Error|Least Squares Mean
2687658|NCT01340027|Secondary|Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours|The average number of micturitions (urinations) per 24 hours was derived from the number of urinations (excluding incontinence only episodes) per day recorded by the participant in the micturition diary for 3-days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|Full analysis set; LOCF was used.|||micturitions||Standard Error|Least Squares Mean
2687659|NCT01340027|Primary|Change From Baseline to End of Treatment (EOT) in Mean Volume Voided Per Micturition|The average volume voided per micturition was calculated from the volume of each micturition measured by the participant and recorded in a micturition diary for 3 days before the Baseline and Week 12 clinic visits.|Baseline and Week 12|The Full Analysis Set (FAS) comprised all participants took at least 1 dose of double-blind study medication after randomization and had primary efficacy data (mean volume voided) derived from the diary at Baseline and at least 1 post-baseline visit. Last observation carried forward imputation (LOCF) was utilized.|||mL||Standard Error|Least Squares Mean
2687660|NCT01340014|Secondary|Ocular Discomfort|Ocular discomfort was assessed by the participant 1 minute after instillation of the study medication. Ocular discomfort was rated on a 10-point scale (0=no discomfort, 9=substantial discomfort).|Day 7 of each period|This reporting group includes all participants who completed both treatment periods and completed the preference questionnaire, as treated, minus any missing responses.|||Units on a scale||Standard Deviation|Mean
2687661|NCT01340014|Primary|Preferred Treatment|"The participant completed a questionnaire on the Day 15 visit (ie, after administration of both study medications) consisting of a single preference question: Thinking about the comfort of the two medications (1st and 2nd) that you took during this study, which medication do you prefer? Preferred treatment is presented as a percentage."|At the end of both periods, Day 15|This reporting group includes all participants who completed both treatment periods and completed the preference questionnaire, as treated.|||Percentage of participants|||Number
2687662|NCT01339936|Secondary|Ocular Surface Disease Index Score|"The OSDI is a 12-item patient-reported outcomes questionnaire designed to assess the range of ocular surface symptoms, their severity, and their impact on the patient's ability to function.~The OSDI items are scored on a 0 to 4 Likert-type scale, where 0 = None of the time, 1 = Some of the time, 2 = Half of the time, 3 = Most of the time, and 4 = All of the time. Using individual item responses, an overall OSDI score is calculated. The overall OSDI score ranges from 0 to 100, where a score of 100 corresponds to complete disability while a score of 0 corresponds to no disability."|after 30 days of eye drop usage||||points||Standard Deviation|Mean
2687663|NCT01339936|Secondary|Tear Break Up Time|The tear film break-up-time (BUT) is the time elapsed between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with a wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability. Three independent measurements were recorded in each case and the median value over the three measurements calculated. The latter value constituted the secondary endpoint used in the analysis.|after 30 days of eyedrop usage|The analysis was carried out on subjects having completed the study according to the protocol e.g. 35|||seconds||Standard Deviation|Mean
2687664|NCT01339936|Primary|Tear Film Evaporation Rate|The rate of evaporation of the tears from the ocular surface was measured. To do so the participant was required to wear a sealed goggle over the eye, which served to isolate the air surrounding the ocular surface. The temperature and humidity were measured within the sealed goggle during closed eye and open eye situations. The evaporation from the ocular surface was calculated by taking the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in 10^-7 g/cm^2 /s and recorded for relative humidity of 25% to 35%.|after 30 days of eyedrop usage|The analysis was carried out on subjects having completed the study according to the protocol e.g. 35|||10^-7g/cm^2/sec||Standard Deviation|Mean
2687665|NCT01339923|Secondary|Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Group BC_35_12 and C_35_12|Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on unsolicited safety set.|Day 1 to Day 301 for BC_35_12 and C_35_12, Day 302 to Day 391 for C_35_12; Day 1 to day 7 (All AEs)|Unsolicited safety set|||Number of subjects|||Number
2707422|NCT01191242|Primary|(R)-Methadone Trough Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
2687666|NCT01339923|Secondary|Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_02_2_5 and B_02_6_10|Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV NZ. Analysis was done on unsolicited safety set.|Day 1 to day 7 (All AEs). Throughout the study period (SAEs, medically attended or leading to premature withdrawal AEs)|Unsolicited safety set|||Number of subjects|||Number
2687667|NCT01339923|Secondary|Number of Subjects Reporting Unsolicited AEs Following Any Vaccination With rMenB+OMV NZ in Groups B_2h3h5_11, B_3h5_11 and B_68_11|Safety was assessed in terms of number of subjects reporting any unsolicited AEs (day 1-7 after any vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal from the study (collected throughout the study period) following any vaccination with rMenB+OMV. Analysis was done on unsolicited safety set.|Until 12 months of age; Day 1 to day 7 (All AEs)|Unsolicited safety set|||Number of subjects|||Number
2687668|NCT01339923|Secondary|Number of Subjects With Solicited Local and Systemic AEs in Groups BC_35_12 and C_35_12 After Any rMenB+OMV NZ or MenC-CRM Vaccination|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on solicited safety set.|Day 1 to day 7 after any vaccination|Solicited safety set|||Number of subjects|||Number
2687669|NCT01339923|Secondary|Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any rMenB+OMV NZ or MenC-CRM Vaccination|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination with rMenB+OMV NZ or MenC-CRM. Analysis was done on solicited safety set.|Within 30 minutes after any vaccination|Solicited safety set|||Number of subjects|||Number
2687670|NCT01339923|Secondary|Number of Subjects With Solicited Local and Systemic AEs in Groups B_02_2_5 and B_02_6_10|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination in subjects aged 2- 10 years who received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Analysis was done on solicited safety set.|Day 1 to day 7 after any vaccination|Solicited safety set|||Number of subjects|||Number
2687671|NCT01339923|Secondary|Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination - Groups B_02_2_5 and B_02_6_10|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination in subjects aged 2 - 10 years who received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Analysis was done on solicited safety set.|Within 30 minutes after any vaccination|Solicited safety set|||Number of subjects|||Number
2687672|NCT01339923|Secondary|Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) Following a 3 or 4-dose Regimen of rMenB+OMV NZ|Safety was assessed in terms of number of subjects with solicited local and systemic AEs after any vaccination following a 4-dose regimen (2.5, 3.5, 5 and 11 months) or as a 3-dose regimen (3.5, 5 and 11 months or 6, 8 and 11 months) of rMenB+OMV NZ. Analysis was done on solicited safety set.|Day 1 to day 7 after any vaccination|Solicited safety set|||Number of subjects|||Number
2687673|NCT01339923|Secondary|Number of Subjects Who Reported Immediate Reactions Within 30 Minutes After Any Vaccination With rMenB+OMV NZ|Safety was assessed in terms of number of subjects who reported immediate reactions within 30 minutes following a 4-dose regimen (2.5, 3.5, 5 and 11 months) or a 3-dose regimen (3.5, 5 and 11 months or 6, 8 and 11 months) of rMenB+OMV NZ. Analysis was done on solicited safety set.|Within 30 minutes after any vaccination|Solicited safety set.|||Number of subjects|||Number
2687674|NCT01339923|Secondary|Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM - Persistence|Immunogenicity was assessed in terms of GMTs against Geometric mean ELISA concentrations against N meningitidis serogroup B vaccine antigen 287-953, following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence.|Pre-booster vaccination (persistence; 12 months of age)|FAS-persistence|||IU/mL||95% Confidence Interval|Geometric Mean
2687675|NCT01339923|Secondary|Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM|Immunogenicity was assessed in terms of Geometric mean ELISA concentrations against N meningitidis serogroup B vaccine antigen 287-953, following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-primary and FAS-booster.|1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination|FAS-primary and FAS-booster|||IU/mL||95% Confidence Interval|Geometric Mean
2687676|NCT01339923|Secondary|GMTs Against N. Meningitidis Serogroup B Strains Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM|Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence and FAS-booster.|1 month after second vaccination, pre-booster vaccination and 1 month after booster vaccination|FAS-persistence and FAS-booster|||Titers||95% Confidence Interval|Geometric Mean
2687677|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following co-administration of MenC-CRM and rMenB+OMV NZ at 3 and 5 months and a booster at 12 months. Analysis was done on FAS-primary series and FAS-booster.|1 month after second vaccination and 1 month after booster vaccination|FAS-primary series and FAS-booster|||Percentages of subjects||95% Confidence Interval|Number
2687678|NCT01339923|Secondary|GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone - Persistence|Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-persistence.|Pre-booster vaccination (persistence; 12 months of age)|FAS-persistence|||Titers||95% Confidence Interval|Geometric Mean
2687706|NCT01339910|Secondary|Percentage of Participants With Relapse-Free Survival (RFS)|Relapse-free survival is defined as survival without relapse of the primary disease.|18 months post-randomization||||percentage||95% Confidence Interval|Number
2687679|NCT01339923|Secondary|GMTs Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone|Immunogenicity was assessed in terms of GMTs against N meningitidis serogroup C strain following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months. Analysis was done on FAS-primary series and FAS-booster.|1 month after second vaccination, 1 month after booster vaccination|FAS-primary series and FAS-booster|||Titers||95% Confidence Interval|Geometric Mean
2687680|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 8 Against Serogroup C Following Concomitant Administration of rMenB+OMV NZ With MenC-CRM or MenC-CRM Alone|Non-inferiority of MenC-CRM was determined following co-administration of MenC-CRM and rMenB+OMV NZ or MenC-CRM alone at 3 and 5 months and booster dose at 12 months, as measured by the percentages of subjects achieving hSBA titers ≥ 8 against serogroup C. Analysis was done on PPS-primary series and PPS-booster.|Baseline, 1 month after second vaccination and 1 month after booster vaccination|PPS-primary series and PPS-booster.|||Percentages of subjects||95% Confidence Interval|Number
2687681|NCT01339923|Secondary|Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 After a Two Dose Catch-up rMenB+OMV NZ Immunization Series in Children 2-10 Years of Age|Immunogenicity was assessed in terms of Geometric mean ELISA concentrations (GMCs) against N meningitidis serogroup B vaccine antigen 287-953, after a two dose catch-up immunization series with rMenB+OMV NZ in children 2-10 years of age. Analysis was done on FAS-primary series.|1 month after second vaccination|FAS-primary series|||IU/mL||95% Confidence Interval|Geometric Mean
2687682|NCT01339923|Secondary|Geometric Mean ELISA Concentrations Against Vaccine Antigen 287-953 Following 2 or 3-dose Primary Series and Booster Dose of Vaccination With rMenB+OMV NZ|Immunogenicity was assessed in terms of Geometric mean ELISA concentrations (GMCs) against N meningitidis serogroup B vaccine antigen 287-953, following 2 or 3 dose primary series and booster dose of rMenB+OMV NZ. Analysis was done on FAS-persistence and FAS-booster.|1 month after primary vaccination, pre-booster vaccination (persistence) and 1 month after booster vaccination|FAS-persistence and FAS-booster|||IU/mL||95% Confidence Interval|Geometric Mean
2687683|NCT01339923|Secondary|Antibody Persistence in Terms of Geometric Mean Titers Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ|Persistence of bactericidal antibodies at 11 months of age was assessed in terms of GMTs against N meningitidis serogroup B indicator strains in subjects who previously received a primary series of 2 or 3-doses of rMenB+OMV NZ. Analysis was done on FAS-persistence.|11 months of age (persistence)|FAS-persistence|||Titers||95% Confidence Interval|Geometric Mean
2687684|NCT01339923|Secondary|Antibody Persistence in Terms of Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (M10713) and hSBA ≥ 8 Following 2 or 3-dose Primary Series of Vaccination With rMenB+OMV NZ|Persistence of bactericidal antibodies at 11 months of age was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713 in subjects who previously received a primary series of 2 or 3-doses of rMenB+OMV NZ vaccine. Analysis was done on FAS-persistence.|11 months of age (persistence)|FAS-persistence|||Percentages of subjects||95% Confidence Interval|Number
2687685|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 Following a Booster Dose of rMenB+OMV Vaccination|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713; hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following a booster dose of rMenB+OMV NZ given at 11 months of age (4th dose for B_2h3h5_11 and 3rd dose for B_3h5_11 and B_68_11). Analysis was done on FAS-booster.|1 month post-booster dose|FAS-booster|||Percentages of subjects||95% Confidence Interval|Number
2687686|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 and hSBA ≥ 8 After First Infant Vaccination With rMenB+OMV|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254, hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713 after the first infant vaccination in groups B_2h3h5_11b, B_3h5_11b and B_68_11b (at 3.5, 5, and 8 months of age respectively). Analysis was done on FAS-post first dose.|Post- first dose (1 month for B_2h3h5_11b, 1.5 month for B_3h5_11b and 2 months for B_68_11b after 1st vaccination)|FAS-post first dose|||Percentages of subjects||95% Confidence Interval|Number
2687687|NCT01339923|Secondary|Geometric Mean hSBA Titers (GMTs) After First Infant Vaccination With rMenB+OMV.|Immunogenicity was assessed in terms of Geometric mean hSBA titers (GMTs) against N meningitidis serogroup B indicator strains after the first infant vaccination in groups B_2h3h5_11b, B_3h5_11b and B_68_11b (after 1 month for group B_2h3h5_11b, 1.5 months for group B_2h3h5_11b and 2 months for group B_68_11b). Analysis was done on FAS-post first dose.|1, 1.5 or 2 months after first infant vaccination|FAS-post first dose|||Titers||95% Confidence Interval|Geometric Mean
2687688|NCT01339923|Secondary|Geometric Mean hSBA Titers (GMTs) Following 2 or 3 Dose Primary Series of Vaccination With rMenB+OMV|"Immunogenicity was assessed in terms of Geometric mean hSBA titers (GMTs) against N meningitidis serogroup B indicator strains following 2 or 3 dose primary series of vaccination rMenB+OMV NZ (1 month after 3rd infant vaccination in B_2h3h5_11 and 1 month after 2nd infant vaccination in B_3h5_11, B_68_11 and B_02).~Analysis was done on FAS-primary series."|1 month after primary series vaccination|FAS-primary series|||Titers||95% Confidence Interval|Geometric Mean
2687689|NCT01339923|Secondary|Percentages of Subjects Achieving Four-fold Rise Over Baseline hSBA Titers Following a 2-dose Catch-up Series of rMenB+OMV Vaccination|"Immunogenicity was assessed in terms of percentages of subjects achieving 4-fold increase in hSBA titers as compared to baseline against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254, M10713; following 2-dose catch-up series of vaccination with rMenB+OMV NZ in healthy children aged 2-10 years (0, 2 month schedule).~Analysis was done on FAS- primary series."|1 month after second vaccination|FAS- primary series|||Percentages of subjects||95% Confidence Interval|Number
2687707|NCT01339910|Primary|Percentage of Participants With Overall Survival (OS)|Overall survival is defined as survival of death from any cause.|18 months post-randomization||||percentage||95% Confidence Interval|Number
2687708|NCT01339897|Secondary|Pharmacokinetics of N6022 Cmax Values on Study Day 7|Pharmacokinetic Analysis of N6022 Cmax values on Study Day 7|Day 7, 24 hours||||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2707423|NCT01191242|Primary|(R)-Methadone Peak Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
2687690|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 2-dose Catch-up Series of rMenB+OMV Vaccination|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713; following 2-dose catch-up series of vaccination with rMenB+OMV NZ in healthy children aged 2-10 years (0, 2 month schedule). Analysis was done on FAS-primary series.|1 month after second vaccination|FAS-primary series|||Percentages of subjects||95% Confidence Interval|Number
2687691|NCT01339923|Secondary|Percentages of Subjects With hSBA Titers ≥ 4, hSBA Titers ≥ 5 (Strain M10713) and hSBA ≥ 8 Following a 3-dose Primary Series of rMenB+OMV Vaccination|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254; hSBA titers ≥ 5 against strain M10713 and hSBA titers ≥ 8 against strains H44/76, 5/99, NZ98/254, M10713, following 3-dose primary series of vaccination with rMenB+OMV NZ at 2.5, 3.5 and 5 months of age. Analysis was done on FAS-primary series.|1 month after third vaccination|FAS-primary series|||Percentages of subjects||95% Confidence Interval|Number
2687692|NCT01339923|Primary|Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination.|Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254 and hSBA titers ≥ 5 against strain M10713 following 2-dose primary series of vaccination with rMenB+OMV NZ at 3.5 and 5 months of age or at 6 and 8 months of age. Analysis was done on Full analysis set (FAS)-Primary series.|1 month after second vaccination|FAS-Primary series|||Percentages of subjects||97.5% Confidence Interval|Number
2687693|NCT01339910|Secondary|Number of Participants With Cause of Death|Primary cause of death was adjudicated using previously described criteria (Copelan et al. 2007). When relapse occurred, it was considered the primary cause of death regardless of other events.|18 months post-randomization||||Participants|||Count of Participants
2687694|NCT01339910|Secondary|Number of Participants With Infections|"The maximum severity of infections reported by participants are tabulated.~The number of infections and the number of patients experiencing infections will be tabulated by type of infection, severity, and time period after transplant. The cumulative incidence of severe, life-threatening, or fatal infections will be compared between the two treatment arms at 6, 12, and 18 months from transplant or until death."|18 months post-transplant|Transplanted participants|||Participants|||Count of Participants
2687695|NCT01339910|Secondary|Infection Type|The number and types of infection events reported are tabulated.|18 months post-transplant|Infection events|||Infection events|Infection events||Count of Units
2687696|NCT01339910|Secondary|Number of Participants With Maximum Grade 3-5 Toxicities|"The maximum grade of toxicities reported by participants over the study duration are tabulated. Per the CTCAE criteria, toxicities are graded on a scale of 0-5, with higher numbers indicating greater severity. The categories correspond as follows:~3 - severe; 4 - life-threatening; 5 - fatal"|18 months|Transplanted participants|||Participants|||Count of Participants
2687697|NCT01339910|Secondary|Number of Participants With Secondary Graft Failure|Secondary graft failure is defined by initial neutrophil engraftment followed by subsequent decline in neutrophil counts to less than 500x10^6/liter that is unresponsive to growth factor therapy.|18 months post-transplant|Transplanted participants|||Participants|||Count of Participants
2687698|NCT01339910|Secondary|Number of Participants With Primary Graft Failure|Primary graft failure is defined by lack of neutrophil engraftment.|28 days post-transplant|Transplanted participants|||Participants|||Count of Participants
2687699|NCT01339910|Secondary|Number of Participants With Chronic GVHD Severity|Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe.|18 months post-transplant|Transplanted participants|||Participants|||Count of Participants
2687700|NCT01339910|Secondary|Percentage of Participants With Chronic GVHD|Chronic GVHD is classified per 2005 NIH Consensus Criteria (Filipovich et al. 2005) into categories of severity: none, mild, moderate, and severe. Occurrence of chronic GVHD is defined as the occurrence of mild, moderate, or severe chronic GVHD per this classification.|18 months post-transplant|Transplanted participants|||percentage||95% Confidence Interval|Number
2687701|NCT01339910|Secondary|Percentage of Participants With Acute Graft Versus Host Disease (GVHD)|"Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:~Skin stage:~0: No rash~Rash <25% of body surface area~Rash on 25-50% of body surface area~Rash on > 50% of body surface area~Generalized erythroderma with bullous formation~Liver stage (based on bilirubin level)*:~0: <2 mg/dL~2-3 mg/dL~3.01-6 mg/dL~6.01-15.0 mg/dL~>15 mg/dL~GI stage*:~0: No diarrhea or diarrhea <500 mL/day~Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD~Diarrhea 1000-1499 mL/day~Diarrhea >1500 mL/day~Severe abdominal pain with or without ileus * If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.~GVHD grade:~0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4"|Day 100 post-transplant|Transplanted participants|||percentage||95% Confidence Interval|Number
2687702|NCT01339910|Secondary|Number of Participants With Donor Cell Engraftment|Donor cell engraftment will be assessed by donor-recipient chimerism assays. Full donor chimerism is defined as the presence of at least 95% donor cells as a proportion of the total population in the peripheral blood or bone marrow. Graft rejection is defined as the presence of no more than 5% donor cells as a proportion of the total population. Mixed chimerism is defined as the presence of between 5% and 95% donor cells. Mixed or full donor chimerism will be considered evidence of donor engraftment.|Days 28 and 100 and 18 months post-transplant|Transplanted participants|||Participants|||Count of Participants
2687703|NCT01339910|Secondary|Percentage of Participants With Neutrophil and Platelet Engraftment|Neutrophil engraftment is defined as achieving an absolute neutrophil count greater than 500x10^6/liter for 3 consecutive measurements on different days. The first of the 3 days will be designated the day of neutrophil engraftment. Platelet engraftment is defined as achieving platelet counts greater than 20,000/microliter for consecutive measurements over 7 days without requiring platelet transfusions. The first of the 7 days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 7 days.|Days 28 and 60 post-transplant|Transplanted participants|||percentage|||Number
2687713|NCT01339858|Secondary|Symptoms of a Psychotic Disorder|determine if 12 months of NAC add-on treatment is superior to placebo for symptom management of a psychotic disorder as assessed by the Clinical Global Impressions Severity Scale (CGI-S). The CGI-S is used for repeated evaluations of global psychopathology and is a 7 point Likert scale rating severity on a scale of 1 (normal, not ill) to 7 (very severely ill).|12 months||||scores on a scale||Standard Error|Least Squares Mean
2687714|NCT01339858|Primary|Cortical Volume|We anticipate that 12 months treatment with NAC as an add-on treatment will show a difference in cortical volume than treatment with placebo|12 months||||mm^3||Standard Error|Least Squares Mean
2687715|NCT01339858|Secondary|Mismatch Negativity Voltage Differences|Determine if 12 months of NAC add-on treatment is superior to placebo for attention measures as measured by the voltage of the Mismatch Negativity (MMN) of the event-related potential. The voltage of the peak MMN response was measured at the Fz electrode site.|12 months||||microvolts||Standard Error|Least Squares Mean
2687716|NCT01339858|Secondary|Functional Status|determine if 12 months of NAC add-on treatment is superior to placebo for functional measures as measured by the Personal and Social Performance Scale (PSP). The PSP scale is a 100-point, single item, clinician rated scale to assess 4 domains of functioning, including personal and social relationships, socially useful activities, self care and disturbing and aggressive behaviors. A score from 0-100 is generated, with a higher score representing better performance.|Baseline and 12 months||||scores on a scale||Standard Error|Least Squares Mean
2687717|NCT01339858|Secondary|Cognitive Functioning|determine if 12 months of NAC add-on treatment is superior to placebo for cognitive functioning as measured by the Brief Assessment of Cognition in Schizophrenia (BACS). The BACS is a battery specifically designed to measure treatment-related changes in cognition by utilizing 6 tasks, and has alternate forms, thus minimizing practice effects. Each task generates a raw score (with a higher score indicating better performance): verbal memory 0-75; digit sequencing 0-28; token motor task 0-100; semantic&letter fluency 0-148; symbol coding 0-110; and tower of London 0-22. The raw scores are used to generate a composite score that is calculated by summing t-scores derived by comparisons with a normative sample of 404 healthy controls. The six brief assessments' t-scores, are summed, and averaged to provide a composite t-score. The composite score min and max are between -43 and 100. A higher score indicating better cognitive performance.|Baseline and 12 months||||scores on a scale||Standard Error|Least Squares Mean
2687718|NCT01339858|Secondary|Symptoms of a Psychotic Disorder|Determine if 12 months of NAC add-on treatment is superior to placebo for symptom management of a psychotic disorder as assessed by the Positive and Negative Syndrome Scale (PANSS). The PANSS is a semi-structured interview, containing 30 items that assess positive, negative, and general psychopathology symptoms. Positive symptoms=7 items, negative symptoms=7 items, and general psych.=16 items. Scores for each item range from 1-absent to 7-extreme. To calculate total score, all items on the scale are summed to yield a score from 30-210,a lower score reflecting fewer symptoms. To calculate factor scores various items from positive, negative, and general psych. are summed together to yield Cognitive/Disorganized, Negative, and Positive factor scores. Cog/Disorg factor scores sum 7 items, ranging from 7-49. Neg factor scores sum 7 items, ranging from 7-49. Pos factor scores sum 8 items, ranging from 8-56. For all factor scores a lower score reflects less symptom severity.|12 months||||scores on a scale||Standard Error|Least Squares Mean
2687719|NCT01339858|Secondary|Attention Measures|determine if 12 months of NAC add-on treatment is superior to placebo for attention measures (e.g., mismatch negativity, P300) as measured by electrophysiology methods. Electrophysiology measures will be recorded from a 64 channel, silver/silver-chloride scalp electrode montage.|12 months||||Hz||Standard Error|Least Squares Mean
2687720|NCT01339858|Secondary|Number of Participants With Glutamine/Glutamate Level Changes|Identify number of participants with 12 months of NAC treatment who had glutamine/glutamate level changes as measured by cortical magnetic resonance spectroscopy measures.|12 months|Several subjects were excluded from the MR spectroscopy measures due to visible motion between image acquisitions. Data were not collected for the Placebo group.|||Participants|||Count of Participants
2687721|NCT01339858|Secondary|Working Memory|determine if 12 months of NAC add-on treatment is superior to placebo as determined by brain activity during n-back working memory task during fMRI.|Baseline and 12 months||||Bold signal change||Standard Deviation|Mean
2687722|NCT01339858|Primary|Cortical Thickness|We anticipate that 12 months treatment with NAC as an add-on treatment will show significantly less cortical erosion as measured by cortical thickness than treatment with placebo|12 months||||mm||Standard Error|Least Squares Mean
2687723|NCT01339832|Secondary|Incidence of Adverse Event (AE) and Serious Adverse Event (SAE)|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.|||participants|||Number
2687724|NCT01339832|Secondary|Long Term Side Effects|Long term side effects for bowel and urinary function was assessed. Bowel function was assessed in terms of mean bowel frequency, regular use of constipating agents as well as fecal incontinence. Urinary function was evaluated according to the presence (YES or NO) of incontinence. Overall participant satisfaction was assessed in terms of satisfaction with bowel, stoma and urinary function on a 4-stage scale (very good, good, poor, and very poor). In case of different assessment(s) of bowel or urinary function within the same surveillance period, the assessment with worst grade was documented and reported.|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.|||participants|||Number
2687764|NCT01339260|Secondary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1||0-120 hours|FAS|||percentage of responders||95% Confidence Interval|Number
2687725|NCT01339832|Secondary|Compliance to Diagnostic Procedures in Surveillance|The surveillance compliance was calculated per participant in percent and frequencies for methods of diagnostic procedure adhered to, taking into account all expected procedures in the time span the participant participated and was based on the Swiss Society of Gastroenterology (SGG) follow-up care recommendations|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.|||participants|||Number
2687726|NCT01339832|Secondary|Length of Adjuvant Chemotherapy|The length of adjuvant chemotherapy was defined as time between first start date to last stop date of adjuvant chemotherapy regimen. Length of adjuvant chemotherapy was calculated as length [days] = last stop date - first start date + 1, missing day of start and stop date was replaced by 1.|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.|||days||Full Range|Median
2687727|NCT01339832|Secondary|Type of Adjuvant Chemotherapy|The type of therapies administered after primary treatments (chemotherapy, surgery or radiation) was reported|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.|||participants|||Number
2687728|NCT01339832|Secondary|Tumor Recurrence Rate (Local and Distant)|Participant with tumor recurrence were determined by the presence or absence of date of tumor recurrence detection. In case of absence of empty tumor recurrence date it was considered that the participant had not experienced tumor recurrence. Participants with local tumor recurrence ('Was it local to the primary tumor?' answered 'yes'.) compared to participants with distant tumor recurrence (specification for other tumor location given).|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.|||participants|||Number
2687729|NCT01339832|Secondary|Overall Survival|Overall survival (OS) was defined as time from date of first administration of the study medication in ML18280 study to date of death from any cause. Participants without documented date of death were assumed to be alive and were censored at the latest of the following dates: last date alive on survival status pages, last date known to be alive on survival status pages, and last date of tumor assessment (diagnostic procedures or markers) on surveillance pages. OS time in days was calculated as OS [days] =date of death date of first intake+ 1, for participants who died, OS [days]= censoring date date of first intake+ 1, for participants alive, and OS time in months was calculated as OS [months]= 12 *OS [days] /365.25|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.|||months||Full Range|Median
2687730|NCT01339832|Primary|Progression-free Survival|Progression free survival (PFS) was measured from the date of first administration of study medication in ML18280 study to the date of progression or death, whatever the cause. In participants with measurable disease, progression was defined according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. Participants with neither tumor recurrence nor death were censored at the last tumor assessment date they were known to have not progressed (last date of diagnostic procedure or diagnostic marker reported in the surveillance). PFS time in days was calculated as PFS [days]= date of tumor recurrence/death date of first intake + 1, if participant had tumor recurrence confirmed by diagnostic imaging or participant died, then PFS [days] =last diagnostic procedure/marker date- date of first intake+ 1, and if participant survived without tumor recurrence PFS time in months was calculated as PFS [months]= 12 * PFS [days] /365.25|Up to 5 years|Full Analysis Set (FAS) included all the participants who fulfilled the inclusion criteria for this study. This population includes participants who gave informed consent and also those who died or were lost to follow-up before start of ML21875 study.|||months||Full Range|Median
2687731|NCT01339429|Secondary|Number of Participants With Serious Adverse Events|Any adverse events, including bleeding, wound complication, or change in patient condition during the trial period will be recorded.|3 days||||participants|Participants||Number
2687732|NCT01339429|Primary|Maintenance of Negative Pressure|The negative pressure being delivered by the device was measured on a daily basis for three days. Maintenance of negative pressure was defined as negative pressure delivery within 75% of the starting negative pressure amount.|3 days|85 dressings were applied. 5 applications excluded due to a change in patient condition, unrelated to sNPWT. 9 dressings excluded due to occlusion of the drainage tube. 71 dressings were analyzed in total.|||hours|Participants|Standard Deviation|Mean
2687733|NCT01339416|Secondary|Incidence Rate of Death|Incidence rate of death was calculated as the number of events divided by person-time. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. All-cause mortality was used for the analyses.|Up to Week 626|Analysis population included all participants enrolled in the study.|||death per 100 person-years||95% Confidence Interval|Number
2687734|NCT01339416|Secondary|Incidence Rate of Rhabdomyolysis|Incidence rate of rhabdomyolysis was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Rhabdomyolysis was a condition of muscle fibers breakdown.|Up to Week 626|Analysis population included all participants enrolled in the study.|||rhabdomylosis per 100 person-years||95% Confidence Interval|Number
2687735|NCT01339416|Primary|Incidence Rate of Viral Encephalitis|Incidence rate of viral encephalitis was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Viral encephalitis was defined as inflammation of the brain due to virus.|Up to Week 626|Analysis population included all participants enrolled in the study.|||viral encephalitis per 100 person-years||95% Confidence Interval|Number
2687736|NCT01339416|Primary|Incidence Rate of Liver Failure|Incidence rate of liver failure was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.|Up to Week 626|Analysis population included all participants enrolled in the study.|||liver failure per 100 person-years||95% Confidence Interval|Number
2687737|NCT01339416|Primary|Incidence Rate of Myocardial Infarction|Incidence rate of myocardial infarction (MI) was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.|Up to Week 626|Analysis population included all participants enrolled in the study.|||MI per 100 person-year||95% Confidence Interval|Number
2687738|NCT01339416|Primary|Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections|Incidence rate of AIDS-defining opportunistic infections was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Opportunistic infections were those that occurred on immune-compromised participants. AIDS-defining infections included: esophageal candidiasis; pneumocystes jiroveci; non-tuberculous mycobacterium infection; AIDS dementia complex; disseminated cryptococcosis; cytomegalovirus (all sites); wasting syndrome; toxoplasmosis; cytomegalovirus retinitis; mycobacterium tuberculosis; Progressive (Prog.) multifocal leukoencephalopathy; histoplasmosis; cryptosporidiosis; recurrent pneumonia; herpes simplex infection; extra-pulmonary coccidioidomycosis; salmonella septicemia; isosporiasis.|Up to Week 626|Analysis population included all participants enrolled in the study.|||infections per 100 person-years||95% Confidence Interval|Number
2687739|NCT01339416|Primary|Incidence Rate of Malignancies|Incidence rate of malignancies was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Malignancies included acquired immunodeficiency syndrome (AIDS)-defining malignancies and non-AIDS defining malignancies. AIDS-defining malignancies included invasive cervical cancer, non-Hodgkin's lymphoma and kaposis sarcoma; non-AIDS defining malignancies included but not limited to Hodgkin's disease, lung cancer, liver cancer, anal cancer, melanoma of the skin, leukemia, renal cancer, and prostate cancer. Overall data for non-AIDS defining malignancies and individual data for AIDS-defining malignancies was reported. Incidence rate was computed as the number of events per 100 person-years.|Up to Week 626|Analysis population included all participants enrolled in the study. Here, n=participants who were evaluable for this measure at given time points for each group, respectively.|||malignancies per 100 person-years||95% Confidence Interval|Number
2687740|NCT01339403|Primary|Incidence Rate of Viral Encephalitis|Incidence rate of viral encephalitis (VE) was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years. The participants with viral encephalitis were followed-up up to 31st December 2009 (730 Weeks).|Up to Week 730|Analysis population included all participants enrolled in the study.|||VE per 100,000 person-years|||Number
2687741|NCT01339403|Primary|Incidence Rate of All-Cause Mortality|Incidence rate of all-cause mortality was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.|||death per 100,000 person-years|||Number
2687742|NCT01339403|Primary|Incidence Rate of Rhabdomyolysis|Incidence rate of Rhabdomyolysis was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.|||rhabdomyolysis per 100,000 person-years|||Number
2687743|NCT01339403|Primary|Incidence Rate of Liver Related Death|Incidence rate of liver related death was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.|||death per 100,000 person-years|||Number
2687744|NCT01339403|Primary|Incidence Rate of Liver Failure|Incidence rate of liver failure was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.|||liver failure per 100,000 person-years|||Number
2687765|NCT01339260|Secondary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication at Cycle 1||0-24 hours|FAS|||percentage of responders||95% Confidence Interval|Number
2687766|NCT01339260|Primary|Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1||25-120 hours|FAS|||percentage of responders||95% Confidence Interval|Number
2707424|NCT01191242|Primary|(S)- Methadone Trough Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
2687745|NCT01339403|Primary|Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections|Incidence rate of AIDS-defining opportunistic infections (OI) was calculated as the number of events divided by person-time.Only the first diagnosis of each event per participant was included.Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1,1996 for KPNC and January 1,2000 for KPSC if in care prior to this date.OI were those that occurred on immune-compromised participants.AIDS-defining infections included:wasting syndrome;pneumocystis jirovecii pneumonia;recurrent pneumonia;cytomegalovirus;HIV-related encephalopathy;esophageal candidiasis;mycobacterium avium complex;cryptococcosis;mycobacterium tuberculosis;progressive multifocal leukoencephalopathy;lung candidiasis;toxoplasmosis of brain;coccidiomycosis;histoplasmosis;recurrent salmonella septicemia;chronic isosporiasis;cryptosporidiosis.Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.|||infections per 100,000 person-years|||Number
2687746|NCT01339403|Primary|Incidence Rate of Myocardial Infarction and Ischemia|Incidence rate of cardiovascular (CVS)events including myocardial infarction (MI) and ischemia was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual who were KP member from the date of HIV care initiation at that institution or January 1, 1996 for KPNC and January 1, 2000 for KPSC if in care prior to this date. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.|||CVS events per 100,000 person-years|||Number
2687747|NCT01339403|Primary|Incidence Rate of Malignancies|Incidence rate of malignancies was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included.Person-time was calculated as the sum of all time contributed by each individual who were Kaiser Permanente (KP) member from the date of HIV care initiation at that institution or January 1, 1996 for KP Northern California(KPNC) and January 1, 2000 for KP Southern California(KPSC) if in care prior to this date. Malignancies included acquired immunodeficiency syndrome (AIDS)-defining malignancies and non-AIDS defining malignancies.AIDS-defining malignancies included invasive cervical cancer,invasive non-Hodgkin's lymphoma and kaposi's sarcoma;non-AIDS defining malignancies cancers ascertained from the KP cancer registries.Overall data for non-AIDS and AIDS defining malignancies, along with individual data for AIDS-defining malignancies was reported. Incidence rate was computed as the number of events per 100,000 person-years.|Up to Week 835|Analysis population included all participants enrolled in the study.|||malignancies per 100,000 person-years|||Number
2687748|NCT01339390|Primary|Change in Weight (From Baseline)|Weight as recorded in the medical record during a 6-month period around the follow-up point.|Measured at 12 and 24 months|For the analysis, we included those lost to follow up by using the last observation carried forward to impute missing values|||Pounds||Standard Deviation|Least Squares Mean
2687749|NCT01339299|Primary|The Oestradiol Concentration on the Day of Ovulation Induction||treatment day 10 to 14||||pmol/L||Standard Deviation|Mean
2687750|NCT01339273|Secondary|Time to Hospital Discharge||days|data lost on follow up|||days||Inter-Quartile Range|Median
2687751|NCT01339273|Secondary|Time to Mobilization||days|data lost in follow up|||days||Inter-Quartile Range|Median
2687752|NCT01339273|Secondary|Nausea at 24hours Post Operatively||24 hours|data lost during follow up|||units on a scale||Inter-Quartile Range|Median
2687753|NCT01339273|Secondary|Total Morphine Consumption at 24hours||24 hours||||mg||95% Confidence Interval|Mean
2687754|NCT01339273|Secondary|Time to Medically Fit to Discharge|Time will be calculated from the medical notes, when the decision that the patient is medically fit to be discharged was made.|After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.||||days||Full Range|Median
2687755|NCT01339273|Secondary|Time to First Flatus|Time will be calculated from the nursing notes and patient diary, when the patient first passed flatus.|After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.||||days||Full Range|Median
2687756|NCT01339273|Secondary|Time to First Bowel Motion|Time will be calculated from the nursing notes and patient diary, when the patient had the first bowel motion.|After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.||||days||Full Range|Median
2687757|NCT01339273|Secondary|Time to Resumption of Normal Diet|Time will be calculated from the nursing notes and patient diary, when the patient resumed normal diet.|After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.||||days||Full Range|Median
2687758|NCT01339273|Secondary|Time to Successful Intake of Fluids|Time will be calculated from the nursing notes and patient diary, when the patient had first successful intake of oral fluids.|After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.||||days||Full Range|Median
2687759|NCT01339273|Secondary|Time to Mobilisation|Time will be calculated from the nursing notes and patient diary, when the patient was first mobilised.|After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.||||days||Full Range|Median
2687760|NCT01339273|Secondary|Time to First Request for Rescue Analgesia|The time will be calculated from the drug chart looking up when the first dose of rescue morphine was administered|After the operation patients will be followed up till they are medically fit to be discharged from the hospital an expected average of 5-7 days.|data were not collected||||||
2687761|NCT01339273|Secondary|Nausea Score at 48 Hours Postoperatively|0-10 0= no nausea 10=severe nausea|48 hours after the operation||||units on a scale||Inter-Quartile Range|Median
2687762|NCT01339273|Secondary|Numerical Rating Pain Scores at 48 Hours Postoperatively|Numerical Rating Scores for Pain (0-10) 0= no pain 10= severe pain|48 hours after the operation||||units on a scale||Inter-Quartile Range|Mean
2687763|NCT01339273|Primary|Morphine Consumption in the First 48hours After the Operation|Total morphine consumption in the first 48 hours after the surgery will be calculated from the drug chart and the Patient controlled analgesia(PCA)pump.|48 hours after the operation||||mg||95% Confidence Interval|Mean
2687767|NCT01339247|Primary|Cmax_ss|"Cmax_ss is defined as the maximum or peak concentration of a drug observed after its administration, in steady-state. Cmax_ss is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed."|Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)|Entire study population|||ng/ml||Standard Deviation|Mean
2687768|NCT01339247|Primary|Cmin_ss|Cmin_ss is defined as the minimum concentration of a drug observed after its administration, in steady-state. Cmin_ss is one of the parameters of particular use in estimating the bioavailability of drugs, for studies employing multiple doses.|Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)|Entire study population|||ng/ml||Standard Deviation|Mean
2687769|NCT01339247|Primary|AUC_ss|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC_ss is the area under the curve during the steady-state period. The AUC_ss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; h, hour; ml, milliliter; ng.h/ml, nanograms per hour per milliliter.|Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)|Entire study population|||ng.h/ml||Standard Deviation|Mean
2687770|NCT01339091|Secondary|Clinical Status|Compare the clinical efficacy at the day 28 follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of non-study antibiotics|Follow-Up Visit (day 28)|Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.|||participants|||Number
2687771|NCT01339091|Secondary|Clinical Status|Compare the clinical efficacy at end of treatment visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of non-study antibiotics|End of Treatment Visit (Day 14-15)|Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.|||participants|||Number
2687772|NCT01339091|Secondary|>= 20% Reduction in Lesion Area|Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size|48-72 hours after the initiation of study therapy|The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.|||participants|||Number
2687773|NCT01339091|Primary|Early Clinical Efficacy|Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size and temperature|48-72 hours after the initiation of study therapy|The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.|||participants|||Number
2687774|NCT01339052|Secondary|Grade 3-5 Treatment-Related Toxicity Rate|The percentage of patients who experienced any grade 3-5 treatment-related adverse event based on CTCAEv4 as reported on case report forms.|Adverse events experienced by participants are collected and reported throughout treatment with study drug (from initiation of study medication until 30 days after the last dose of BKM120), maximum timeframe was 2 years.|The analysis dataset is comprised of all treated patients.|||percentage of patients||90% Confidence Interval|Number
2687775|NCT01339052|Secondary|Progression-Free Survival (PFS) [Cohort 2]|PFS is defined as the time from first dose to the earliest documentation of disease progression or death. Participants alive without evidence of PD were censored at the date of last disease assessment. Progressive disease was established based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010). See outcome measure #2.|Participants were assessed radiologically every other cycle on treatment and off-treatment via medical record review until death. Cohort 2 participants were followed for progression-free survival up to 12 months in this study cohort.|The analysis dataset is comprised of all treated participants.|||months||95% Confidence Interval|Median
2687776|NCT01339052|Secondary|Overall Survival (OS) [Cohort 2]|Overall survival is defined as the time from date of first dose to death or date last known alive and estimated using Kaplan-Meier (KM) methods.|Participants were followed long-term for survival via medical record review. Cohort 2 participants were followed for survival up to 52 months in this study cohort.|The analysis dataset is comprised of all treated participants.|||months||95% Confidence Interval|Median
2687777|NCT01339052|Secondary|Time to Maximum Observed Plasma Concentration (Tmax) of BKM120 Day 1 and Day 8 [Cohort 1]|Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods.|On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.|The analysis dataset is comprised of all treated patients.|||hours||Full Range|Median
2687778|NCT01339052|Secondary|AUC0-5h Accumulation Ratio of BKM120 Day 1 and Day 8 [Cohort 1]|"Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods.~The accumulation ratio is day 8/day 1."|On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.|The analysis dataset is comprised of all treated patients.|||ratio day 8/day 1||Full Range|Mean
2687779|NCT01339052|Secondary|Area Under the Concentration Curve From Time 0 to Last Concentration (AUC0-5h) of BKM120 Day 1 and Day 8 [Cohort 1]|"Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods.~NOTE: This outcome measure was previously titled: Investigate Pharmacokinetics of BKM120 in This Population by Comparing the Drug Exposure Area Under the Curve (AUC0-5h) From Day 1 to Day 8"|On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.|The analysis dataset is comprised of all treated patients.|||ug*h/mL||Standard Deviation|Mean
2687780|NCT01339052|Secondary|Cmax Accumulation Ratio of BKM120 Day 1 and Day 8 Ratio [Cohort 1]|Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods. The accumulation ratio is day 8/day 1.|On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.|The analysis dataset is comprised of all treated patients.|||ratio day 8/day 1||Full Range|Mean
2687781|NCT01339052|Secondary|Maximum Observed Plasma Concentrations (Cmax) of BKM120 Day 1 and Day 8 [Cohort 1]|"Plasma concentrations of BKM120 were analyzed by a validated liquid chromatography-tandem mass spectrometry assay developed by Novartis Pharma AG. Standard Pk parameters were determined using non-compartmental methods.~NOTE: This outcome measure was previously titled: Investigate Pharmacokinetics of BKM120 in This Population by Comparing Maximum Plasma Concentrations (Cmax) From Day 1 to Day 8"|On days 1 and 8 (+/- 1 day) prior to surgery, 5 blood samples were collected at the following timepoints: pre-dose, and at 0.5, 1.5, 3, and 5 hours post-dose.|The analysis dataset is comprised of all treated patients.|||ng/mL||Standard Deviation|Mean
2687782|NCT01339052|Secondary|Radiographic Response [Cohort 2]|Radiographic response was based on RANO (Response Assessment in Neuro-Oncology) criteria. Per RANO, complete response (CR): 1) Complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks, 2) No new lesions, 3) All lesions assessed using the same techniques as baseline, 4) No steroid use (or on physiologic replacement doses only), 5) Stable or improved non-enhancing (T2/FLAIR) lesions and 6) Stable or improved clinically; partial response (PR): 1) >/= 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions (sum LD) sustained for at least 4 weeks and 2) No progression; progressive disease (PD): 1) > 25% increase sum LD and/or 2) significant increase in T2/FLAIR, 3) any new lesion, 4) clear clinical deterioration; stable disease (SD): none of the above.|Participants were assessed radiologically every other cycle on treatment. Cohort 2 participants were on treatment up to 9.2 months.|Only those participants who had measurable disease present at baseline and received at least one dose of therapy are considered evaluable for radiographic response|||Participants|||Count of Participants
2687783|NCT01339052|Secondary|% Ki-67 Reduction Using Immunohistochemistry (IHC) [Cohort 1]|Tumor cell proliferation and tumor cell death was using immunohistochemistry for Ki-67 based on established methods. Percent reduction was based on Ki-67 levels at baseline and at surgery.|Samples were collected at baseline (archival tumor specimen) and at surgery (surgical tumor specimen) which occurred after up to 12 days of BTK120 treatment.|The analysis dataset is comprised of all participants with a resected surgical tumor specimen (evaluable).|||% reduction||Full Range|Median
2687784|NCT01339052|Primary|BKM120 Plasma Concentration at Time of Surgery [Cohort 1]|Levels of BKM120 were determined by liquid chromatography coupled with tandem mass spectrometry.|Samples were collected at surgery which occurred after up to 12 days of BKM120 treatment.|The analysis dataset is comprised of all participants with a plasma sample at surgery (evaluable).|||ng/mL||Standard Deviation|Mean
2687785|NCT01339052|Primary|BKM120 Tumor Tissue Concentration at Time of Surgery [Cohort 1]|Levels of BKM120 were determined by liquid chromatography coupled with tandem mass spectrometry.|Samples were collected at surgery (resected surgical tumor specimen) which occurred after up to 12 days of BKM120 treatment.|The analysis dataset is comprised of all participants with a resected surgical tumor specimen (evaluable).|||ng/gm||Full Range|Geometric Mean
2687786|NCT01339052|Primary|BKM120 Brain-to-Plasma Ratio at Time of Surgery [Cohort 1]|Levels of BKM120 were determined by liquid chromatography coupled with tandem mass spectrometry. BKM120 tumor-to-plasma ratio at time of surgery was calculated based on these levels.|Samples were collected at surgery (surgical tumor specimen and plasma sample) which occurred after up to 12 days of BKM120 treatment.|The analysis dataset is comprised of participants with a paired plasma and brain tumor sample (evaluable). Participants missing a brain tumor sample (n=1) or plasma sample (n=2) are excluded from the calculation.|||ratio tumor-to-plasma||Full Range|Geometric Mean
2687787|NCT01339052|Primary|6-Month Progression-Free Survival (PFS6) [Cohort 2]|PFS6 is the proportion of participants remaining alive and progression-free at 6-months from cycle 1 day 1 of BKM120 treatment. Progressive disease is defined using RANO (Response Assessment in Neuro-Oncology) criteria (Wen et al JCO 2010), which takes modified Macdonald Criteria and adds assessment of non-enhancing lesions. Per RANO, progressive disease (PD) is defined either as > 25% increase in sum of the products of perpendicular diameters of enhancing lesions on stable or increasing doses of corticosteroids, or one or more of the of the following: 1) Significant increase in T2/FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids steroids not due to co-morbid events; 2) Any new lesion; 3) Clear clinical deterioration not attributable to other causes apart from the tumor; or 4) Failure to return for evaluation due to death or deteriorating condition.|Participants were assessed radiologically every other cycle on treatment; Relevant for this outcome is up to month 6 evaluation.|The analysis dataset is comprised of all treated participants.|||proportion of participants||90% Confidence Interval|Number
2687788|NCT01339052|Primary|Change in pAKT (S473) Immunohistochemistry (IHC) Score From Baseline to Surgery [Cohort 1]|pAKT response was determined by pathologist-performed semi-quantitative IHC scoring for pAKT using previously established methods for glioblastoma (GBM) patients. Sample staining scored for intensity on a 0-2+ scale (0 none, 1+ weak positive, 2+ strong positive). Change in pAKT IHC score was the difference in score from baseline to surgery. Participants were classified into 3 groups: a reduction of staining score of one degree or more (considered a response), an increase in score and no change in score.|Samples were collected at baseline and at surgery (resected surgical tumor specimen) which occurred after up to 12 days of BKM120 treatment.|The analysis dataset is comprised of all treated participants.|||Participants|||Count of Participants
2687789|NCT01339013|Primary|Airway Dead Space With Devices for Heat and Moisture Exchange of Respiratory Gas.|A conventional heat and moisture exchanger used in a respiratory circuit during anasthesia was exchanged by an AnaConDa. The AnaConDa causes re-breathing of carbon dioxide which clinically is equivalent to an increased airway dead space. The total airway dead space effect of the AnaConDa, i.e. volume of the device plus rebreathing from the charcoal filter was measured using the Single Breath Test for carbon dioxide, as was airway deadspace of the conventional Heat and Moisture Exchanger. Airway dead space differences between devices was calculated by subtraction of volumes thus achieved. Difference= Airway dead space AnaConDa - Airway dead space conventional Heat and Moisture Exchanger.|1 hour||||mL||95% Confidence Interval|Median
2687790|NCT01339000|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|12 months||||participants|||Number
2687791|NCT01339000|Secondary|Based on the First Two Primary Objectives, Consider and Discuss the Need for Larger Studies to Evaluate the Potential Benefit of Interleukin-7 (CYT107) Administration in a Broad, Mass Protection Strategy for an Aging Population||1 year|Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.||||||
2687794|NCT01339000|Primary|Evaluate and Quantify the Impact of Interleukin-7 (CYT107) Therapy on Specific Immune Responses to Vaccines (in Particular to Neo Antigens) in Older Subjects Following Chemotherapy||8 weeks|Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.||||||
2687795|NCT01338987|Secondary|Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)|Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|Date treatment consent signed to date off study, approximately 79 months and 11 days.|40/45 transplant recipients and all 31 donors were evaluable for adverse events as five patients did not proceed to transplant after enrollment due to progression of disease in four cases and enrollment on a new protocol in one case.|||Participants|||Count of Participants
2687796|NCT01338987|Primary|Number of Adverse Events Related to Study Drug Experienced by Participants After Second Bone Marrow Transplant (BMT)|Serious and non-serious adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.|12 months after second BMT|Only the patients in the SG4 group who had a 2nd BMT had a primary endpoint of toxicity requiring leuprolide AE reporting.|||Adverse Events|||Number
2687797|NCT01338987|Primary|Time to Engraftment in First Transplant Recipients Only With Median Thoracic Spine Standardized Uptake Values (SUV) of 1.4 or Greater Than Those Patients With SUV's Less Than 1.4|18F-FLT imaging was performed serially on patients post transplant to identify the level of uptake of 18F-FLT at a day +5 to +12 scan and the day at which neutrophils recover to >500 (i.e., subclinical bone-marrow recovery within 5 days of Bone Marrow Transplantation (BMT infusion)). On each image for each patient, the region of interest was drawn within each thoracic medullary space (n=12), generating the SUV for each space. The mean of these was calculated for each scan. The analysis was the median of the means of the SUV of the thorax values of the day 5-12 scan (averaged the SUV of the thorax for each patient and then took the medians of these).|18F FLT scan done between days +5 to +12 and then time from that scan to engraftment measured|The pre-specified cohort for this endpoint was 23 first BMT recipients. Only 20 of 23 were evaluable due to inability to obtain the early scan (1) or early relapse (2). As pre-specified in the protocol, all 20 patients were analyzed together as the intention was to look at the imaging modality itself and not any effect of leuprolide.|||Days||Full Range|Median
2687798|NCT01338987|Primary|Percentage of B Cells at One Year Post-transplant in Participants Who Did/Did Not Receive Leuprolide Following Bone Marrow Transplant (BMT)|B cell percentage is defined as the percentage of lymphocytes that are B cells.|after first Bone Marrow Transplant, approximately 12 months post-transplant|Only first BMT patients (SG1-3) with >1 year of follow-up without relapse were evaluable. Of evaluable patients, 5 males and 9 females received and 7 males did not receive Lupron. Reasons for patients being inevaluable were missing data (2) or insufficient follow-up due to death without relapse (3), relapse (11), or withdrawal (1) before 1 year.|||percentage of cells||Full Range|Median
2687799|NCT01338870|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Loss in Body Weight From Baseline|The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c. Participants with >= 1% or >= 2% loss in body weight from baseline signifies an improvement of glycemia.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.|||percentage of participants|||Number
2687800|NCT01338870|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Gain in Body Weight From Baseline|Overweight or obesity increases the risk for developing diabetes. Participants with >= 1% or >= 2% gain in body weight from baseline signifies a higher risk of diabetes.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.|||percentage of participants|||Number
2687801|NCT01338870|Secondary|Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12|Overweight or obesity increases the risk for developing diabetes. The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c.|Baseline, Week 1, 2, 4, 8, 12|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.|||kilogram (kg)||Standard Deviation|Mean
2687802|NCT01338870|Secondary|Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes, and levels of 6.5% or higher indicate diabetes.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.|||percentage of participants|||Number
2687829|NCT01338506|Primary|Clinician Administered PTSD Scale Itemized Scores|"Clinician Administered PTSD Scale Itemized Scores Within the assessment there are 20 symptoms of PTSD, each with an individual score.~A lower score would represent a better outcome (ie less severe symptom). The three itemized symptoms listed below represent hallmark traits/symptoms of PTSD.~Overall score range 0-136 Reexperiencing Symptoms range 0-40 Avoidance/Numbing range 0-56 Hyperarousal range 0-40"|After 12 weeks of treatment||||score on a scale||Standard Deviation|Mean
2707425|NCT01191242|Primary|(S)- Methadone Peak Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
2687803|NCT01338870|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Baseline, Week 1, 2, 4, 8|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure and ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.|||percentage of hemoglobin||Standard Deviation|Mean
2687804|NCT01338870|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12||Baseline, Week 1, 2, 4, 8, 12|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
2687805|NCT01338870|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Baseline, Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm respectively.|||percentage of hemoglobin||Standard Deviation|Mean
2687806|NCT01338857|Primary|Objective Response Rates|Determination of tumor response (CR, PR, SD) will be defined based on the comparison of the baseline MRI performed at study entry to the subsequent MRI which demonstrated best response. PR will be defined by a >15% decrease in tumor volume, as measured by 3D volumetric analysis.|MRIs performed after every 3rd 28-day cycle and off-study|Study terminated and 1/12 participants completed and data was analyzed|||participants|||Number
2687807|NCT01338857|Primary|Response Rate to Sorafenib|To estimate the objective response rates to sorafenib in children and young adults with low-grade astrocytomas, including optic pathway gliomas.|one year|Study terminated and 1/12 participants completed and data was analyzed|||participants|||Number
2687808|NCT01338818|Secondary|Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score|SDS,5-self-rated questionnaire to measure the extent a pt's disability due to an illness/health problem interferes with work/school,social life/leisure,family life/home. First 3 items, pts are asked how their symptoms disrupted their regular activities over the past 7d in each using a scale from 0(not at all)-10(extremely) Each subscale(work disability, social life disability, family life disability)can be scored independently or combined into a total score(sum of the non-missing responses for items 1-3)from 0-30,higher scores indicate significant functional impairment. Subscale scores>5 suggest impairment in that subscale area. Final 2 items ask pts about the # of days their symptoms caused them to miss school/work and # of days their symptoms caused them to be underproductive at school/work.(These items were not included in the total score.) Before responding to SDS items 1-3, pts were verbally instructed to recall the past 7d, items 4-5 refer to the last week w/in the item wording.|week 40 - week 66|All Extension Patients(AEP) analysis set was used for all efficacy and safety analyses of the extension study. AEP was ALL patients who had entered the extension study & received at least 1 dose of Ritalin LA. Enrolment was 299, but 1 pt entered the extension but didn’t receive 1 dose of Ritalin LA and was excluded from AEP Population analysis.|||Scores on a scale||Standard Deviation|Mean
2687809|NCT01338818|Secondary|Change From Extension Baseline (Week 40) to End of Study (Week 66) in on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score.|"Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The DSM-IV ADHD RS total score was calculated as the sum of the Inattentive and the Hyperactive-Impulsive subscores. The 18 items are rated from 0 (rarely or never) to 3 (Very often). The total score ranges from 0 to 54. Decrease in the DSM-IV ADHD RS total score indicates improvement, therefore a greater decrease (change at Final Visit compared to baseline) indicates a greater improvement in ADHD symptoms. Last Observation Carried Forward (LOCF) applied for each patient with data in extension period. If no post-baseline is available, it is considered as missing."|week 40 - week 66|All Extension Patients(AEP) analysis set was used for all efficacy and safety analyses of the extension study. AEP was ALL patients who had entered the extension study & received at least 1 dose of Ritalin LA. Enrolment was 299, but 1 pt entered the extension but didn’t receive 1 dose of Ritalin LA and was excluded from AEP Population analysis.|||scores on a scale||Standard Deviation|Mean
2687810|NCT01338818|Primary|Number of Participants With Adverse Events, Serious Adverse Events and Deaths.|Adverse Events, Serious Adverse Events and Deaths were monitored from week 40 to week 66.|Week 40 - Week 66|All Extension Patients(AEP) analysis set was used for all efficacy and safety analyses of the extension study. AEP was ALL patients who had entered the extension study & received at least 1 dose of Ritalin LA. Enrolment was 299, but 1 pt entered the extension but didn’t receive 1 dose of Ritalin LA and was excluded from AEP Population analysis.|||participants|||Number
2687811|NCT01338792|Secondary|Number of Participants With Serious Adverse Events (SAEs)|Safety evaluation according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.|Baseline, days 1 and 7 of each course, and at last evaluation, up to 1 year|All participants who started treatment were included.|||Participants|||Number
2687812|NCT01338792|Secondary|Time to Disease Progression and Overall Survival|Progression-free survival was defined as the time from the first infusion of study treatment to the date of radiographic disease progression according to RECIST 1.0, or until two consecutive PSA rises occurred with an absolute increase of 5 ng/mL and a 50% relative increase over baseline. For patients without documented disease progression, the date of death or last follow-up without disease progression was used.|Baseline, after every 2 courses, and then every 6 months after off-study (RECIST) until progression; or baseline, day 1 of each course, at the final evaluation, and then every 6 months after off-study (PSA) until progression|Participants who received at least the first infusion of treatment were included.|||Months||95% Confidence Interval|Mean
2688123|NCT01335932|Secondary|Clinical Outcomes|Composite of survival status and >7 days ventilation status, and IL-6 levels. In the composite analysis, the endpoint is composed by death, ventilation status and change of cytokine.|at 14 days post-randomization||||Participants|||Count of Participants
2687813|NCT01338792|Primary|Best Overall Response|For patients with measurable disease, the RECIST 1.0 criteria was used to determine response. Complete Response = disappearance of all target lesions, Partial Response = greater or equal to 30% decrease in sum of longest diameter or target lesions, Stable Disease = <30% decrease or <20% increase, Progressive Disease = greater or equal to 20% increase in longest diameter of target lesions. For patients who do not have measurable disease by RECIST, the response was based on PSA response defined by Prostate Cancer Working Group criteria (1999) as 50% reduction in PSA confirmed on a second measurement at least 4 weeks later.|RECIST evaluation: Baseline, after every 2 courses, and then every 6 months after off-study, up to 1 year. PSA evaluation: baseline, day 1 of each course, final evaluation, and then every 6 months after off-study, up to 1 year|All participants who received at least 1 cycle of treatment were included.|||Participants|||Number
2687814|NCT01338649|Secondary|MSLT and Polysomnograph (PSG) Testing Will be Compared.|MSLT and PSG testing will take place prior to light intervention at screening 2 and post light intervention at week 4.|4 weeks|||||||
2687815|NCT01338649|Secondary|Actigraphy Measures Including Total Sleep Time, Sleep Efficiency, Sleep Fragmentation Index, Frequency of Naps, and Mean Activity Level (a Measurement of Daytime Function) Will be Collected.|Actigraphy measures including total sleep time, sleep efficiency, sleep fragmentation index, frequency of naps, and mean activity levelwill be completed for 3 - 2 week intervals by the subjects at home. Actigraphy measures will be collected at weeks 2, 4 and 6.|6 weeks|||||||
2687816|NCT01338649|Secondary|The Global PSQI Score and PDSS Score Will be Compared.|The global PSQI and PDSS scores will be taken and compared at screening, week 4 and week 6 visits.|6 weeks|||||||
2687817|NCT01338649|Primary|Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure.|ESS score range is 0-24; lower ESS scores indicate less daytime sleepiness; higher ESS scores indicate more severe sleepiness ESS will be taken and compared at screening and week 4 visits between the bright light exposure and dim-red light exposure groups.|baseline and 4 weeks||||score||Standard Deviation|Mean
2687818|NCT01338636|Secondary|World Health Organization Functional Class (WHO FC)|The WHO FC categorizes cardiac disability using four classes, ranging from Class 1 (without limitation of physical activity) to Class 4 (inability to carry on any physical activity without discomfort).|Baseline and Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.|||class||Standard Deviation|Mean
2687819|NCT01338636|Secondary|Borg Dyspnea Scale Score|The Borg Dyspnea Scale measures how breathless the participant feels. Scores range from 0 (no shortness of breath) to 10+ (more short of breath than ever experienced). A score greater that 10 represents very extreme shortness of breath.|Baseline and Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.|||score on a scale||Standard Deviation|Mean
2687820|NCT01338636|Secondary|Change From Baseline in 6-minute Walk Distance (6MWD)|6MWD is the distance walked by the participant in 6 minutes.|Baseline to Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.|||meters||Standard Deviation|Mean
2687821|NCT01338636|Primary|Change From Baseline in Peak Exercise Maximum Oxygen Uptake (VO2max)|VO2max is the measurement of the maximum amount of oxygen that an individual can utilize during intense or maximal exercise.|Baseline to Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.|||percent predicted||Standard Deviation|Mean
2687822|NCT01338636|Primary|Change From Baseline in Peak Exercise Cardiac Output (CO)|CO is the amount of blood pumped by the heart per minute.|Baseline to Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.|||L/min||Standard Deviation|Mean
2687823|NCT01338636|Primary|Change From Baseline in Peak Exercise Pulmonary Vascular Compliance (PVC )|PVC is a measure of a pulmonary vein's ability to expand.|Baseline to Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.|||mL/mmHg||Standard Deviation|Mean
2687824|NCT01338636|Primary|Change From Baseline in Peak Exercise Pulmonary Vascular Resistance (PVR)|PVR is the resistance offered by the pulmonary circulatory system.|Baseline to Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.|||Woods units (WU)||Standard Deviation|Mean
2687825|NCT01338636|Primary|Changes From Baseline in Peak Exercise Mean Pulmonary Artery Pressure (mPAP), Transpulmonary Pressure Gradient (TPG), and Pulmonary Capillary Wedge Pressure (PCWP)|mPAP is measure of the blood pressure found in the main artery of the lung. TPG is the difference between mean pulmonary arterial pressure and left atrial pressure. PCWP is the pressure measured by wedging a pulmonary catheter with an inflated balloon into a small pulmonary arterial branch.|Baseline to Week 24|The analysis population included evaluable participants who completed the 24-week treatment period.|||mmHg||Standard Deviation|Mean
2687826|NCT01338610|Primary|Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28|An electronic Visual Analog Scale (eVAS) was used by the subject to assess ocular discomfort, both frequency and severity, at Day 0 (pre-treatment) and daily thereafter for 28 days. Assessments were entered into a LogPad® (handheld electronic device). The VAS frequency score ranged from 0 (rarely) to 100 (all the time), and the VAS severity score ranged from 0 (very mildly uncomfortable) to 100 (very severely uncomfortable). The Global Ocular Discomfort Score is a composite of the frequency and severity VAS scores (0-100).|Up to 28 days|All subjects randomized to treatment and receiving at least 1 administration of study medication (intent-to-treat). Mixed model repeated measure (MMRM) approach was used to handle missing data during randomized treatment period.|||Units on a scale x days||Standard Error|Least Squares Mean
2687827|NCT01338506|Secondary|Beck Depression Index|Measure of depression. A lower score would indicate less severe depression. Scores range 0-30|Following 12 weeks of therapy.||||units on a scale (BDI)||Standard Deviation|Mean
2687828|NCT01338506|Secondary|Number of Participants Who Report Abstinence|The hypothesis is that COPE will significantly exceed the treatment as usual control group in reducing substance use as measured by decreases in percent days using and increased abstinence rates.|Following 12 weeks of therapy.|Reported rate of abstinence|||Participants|||Count of Participants
2687852|NCT01337986|Secondary|Dalfampridine Effect on Quality of Life Change From Baseline.|Dalfampridine treatment will result in change in quality of life. The National Eye Institute Visual Function Questionnaire consists of 25 questions characterizing visual function at home and in the community. Score ranges from 100 (best) to 0 (worst).|Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)||||NEI VFQ percentage||Full Range|Median
2687830|NCT01338506|Primary|Post-traumatic Stress Disorder Symptomatology|"Score of PTSD from Clinician Administered PTSD Scale (CAPS) and self-administered PTSD Checklist for DSM-5 PTSD Diagnosis (PCL-5).~Lower scores on CAPS and PCL would indicate less severe PTSD. A lower Clinician Administered Post-traumatic Stress Disorder Scale and Post-traumatic Stress Disorder Checklist score would indicate less severe Post-traumatic Stress Disorder/better outcomes.~A negative sign in front of a number represents a decrease in score and better/positive outcomes. A greater decrease in a score represents greater improvement in symptoms (more positive outcomes).~Clinician Administered Post-traumatic Stress Disorder Scale (CAPS): scores range 0-136 0-19: asymptomatic/few symptoms 20-39: mild PTSD/subthreshold 40-59: moderate PTSD/threshold 60-79: severe PTSD symptoms~≥80: extreme PTSD symptoms~Post-traumatic Stress Disorder Checklist: score range 17-85."|Following 12 weeks of therapy.||||score on a scale||Standard Deviation|Mean
2687831|NCT01338506|Primary|Drinks Per Drinking Day|Number of standard drinks reported during drinking day|Following 12 weeks of therapy.||||Number of drinks per drinking day||Standard Deviation|Mean
2687832|NCT01338506|Primary|Change in Post-traumatic Stress Disorder Symptomatology|"The hypothesis is that COPE will significantly exceed the treatment as usual control group in reducing Change in Post-traumatic Stress Disorder symptoms as measured by a reduction of 25 points or more in scores for the Clinician Administered Post-traumatic Stress Disorder Scale (CAPS).~A lower Clinician Administered Post-traumatic Stress Disorder Scale and Post-traumatic Stress Disorder Checklist score would indicate less severe Post-traumatic Stress Disorder/better outcomes.~A negative sign in front of a number represents a decrease in score and better/positive outcomes. A greater decrease in a score represents greater improvement in symptoms (more positive outcomes).~Clinician Administered Post-traumatic Stress Disorder Scale (CAPS): scores range 0-136 0-19: asymptomatic/few symptoms 20-39: mild PTSD/subthreshold 40-59: moderate PTSD/threshold 60-79: severe PTSD symptoms~≥80: extreme PTSD symptoms~Post-traumatic Stress Disorder Checklist: score range 17-85."|Following 12 weeks of therapy.||||score on a scale||95% Confidence Interval|Mean
2687833|NCT01338493|Secondary|Relief of Back Pain at 6 Months Versus Baseline Using the Back Pain Intensity Score Assessed on a 10 cm Visual Analogue Scale (VAS)|"Back Pain was documented in a Visual Analogue Scale where the patients marked the location on the 10-centimeter line corresponding to the amount of pain they experienced.~0 = no pain, 10 = worst possible pain"|6 months|Reduction of disability was calculated for patients having available data at both baseline and 6 months.|||units on a scale||95% Confidence Interval|Mean
2687834|NCT01338493|Primary|Reduction of Disability at 6 Months Versus Baseline Using the Oswestry Disability Index (ODI)|The Oswestry Disability Index (ODI) derives from the Oswestry Low Back Pain Questionnaire, it is used to measure disability for low back pain. The index is scored from 0 to 100; 0 meaning 'no disability' and 100 meaning 'maximum disability'.|6 months|Reduction of disability was calculated for patients having available data at both baseline and 6 months.|||units on a scale||95% Confidence Interval|Mean
2687835|NCT01338415|Other Pre-specified|Overall Survival|Overall survival was defined as the time elapsed between the first study drug administration and death (any cause) up to end of study (Month 18 survival follow-up), regardless of whether the patient was on study treatment. Patients who died, regardless of the cause of death, were considered to have had an event.Patients last known to have been alive were censored on their date of last contact. Percentage of participants without death at different time points was estimated using Kaplan-Meier methodology.|From baseline to month 18|These are the numbers of patients at risk at the time of study treatment initiation in the FUTURE 3 core study|||Percentage of participants||95% Confidence Interval|Number
2687836|NCT01338415|Other Pre-specified|Pulmonary Arterial Hypertension (PAH) Progression up to End of Treatment + 7 Days|PAH progression was defined by time elapsed from the first study drug administration in the FUTURE core study to the day of the first occurrence of any of the following PAH worsening events: death, lung transplant, hospitalization due to PAH progression, initiation of new therapy for PAH or new / worsening right heart failure. Subjects without a PAH worsening event were censored at EOT + 7 days. PAH progression was estimated by Kaplan-Meier methodology and expressed by the percentage of participants free of events at different time points.|From baseline to Month 18|These are the numbers of patients at risk at the time of study treatment initiation in the FUTURE 3 core study|||Percentage of patients free of events||95% Confidence Interval|Number
2687837|NCT01338415|Other Pre-specified|Number of Patients With Pulmonary Arterial Hypertension (PAH) Worsening Components up to the Last Day of Treatment + 7 Days|Number of patients with at least one PAH-worsening component (death, lung transplant, hospitalization due to PAH progression, initiation of new therapy for PAH, new/worsening right heart failure) reported cumulatively over FUTURE 3 core and extension study.|Up to 62 weeks in average|The intent to treat population was used|||Participants|||Count of Participants
2687838|NCT01338415|Other Pre-specified|Change From Baseline up to 18 Months of Study Treatment in the Global Clinical Impression Scale (GCIS)|"The GCIS is a scale used to rate the patient's current overall clinical condition (Very Good, Good, Neither Good or Bad, Bad, and Very Bad). Rating was performed independently by the physician and parents or legal representatives. Baseline was defined as the last valid assessment performed prior to first study drug intake in the FUTURE 3 core study."|At Month 18|The intent to treat population was used. No imputation method was used. Only patients with available results at the corresponding time point are including in the analysis.|||Participants|||Count of Participants
2687839|NCT01338415|Other Pre-specified|Change From Baseline up to 12 Months of Study Treatment in the Global Clinical Impression Scale (GCIS)|"The GCIS is a scale used to rate the patient's current overall clinical condition (Very Good, Good, Neither Good or Bad, Bad, and Very Bad). Rating was performed independently by the physician and parents or legal representatives. Baseline was defined as the last valid assessment performed prior to first study drug intake in the FUTURE 3 core study."|At Month 12|The intent to treat population was used for these analyses. No imputation method was used. Only patients with available results at the corresponding time point are included in the analysis.|||Participants|||Count of Participants
2687888|NCT01337609|Secondary|IBS Severity Scoring System (IBS-SSS)|The IBS-SSS is a validated instrument used to assess common IBS symptoms over the past 10 days including abdominal pain, distention, bowel habit, and global function. The IBS-SSS will be used to assess the absolute change in specific IBS symptoms at endpoint, namely the bloating/distension score.|Adminsitered at each of 8 study visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.||||||
2687840|NCT01338415|Other Pre-specified|Change From Baseline up to 18 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC)|The WHO FC indicates the severity of Pulmonary Arterial Hypertension: class I (none) to class IV (most severe). Changes from baseline to month 12 and month 18 of treatment with bosentan included: improvement ( change from a higher to a lower FC), worsening (change from a lower to a higher FC) or no change/stable (same FC at baseline and at the post-baseline time point). Baseline was defined as the last valid assessment performed prior to first study drug intake in the FUTURE 3 core study.|At Month 18|The intent to treat population was used. Where a missing visit score exists between two visits with scores, the missing score was imputed with the worse score of the non-missing scores; if the missing score was not between 2 visits with scores, it was replaced by the last non-missing score.|||Participants|||Count of Participants
2687841|NCT01338415|Other Pre-specified|Change From Baseline up to 12 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC)|The WHO FC indicates the severity of Pulmonary Arterial Hypertension: class I (none) to class IV (most severe). Changes from baseline to month 12 and month 18 of treatment with bosentan included: improvement ( change from a higher to a lower FC), worsening (change from a lower to a higher FC) or no change/stable (same FC at baseline and at the post-baseline time point). Baseline was defined as the last valid assessment performed prior to first study drug intake in the FUTURE 3 core study.|At Month 12|The intent to treat population was used. Where a missing visit score exists between two visits with scores, the missing score was imputed with the worse score of the non-missing scores; if the missing score was not between 2 visits with scores, it was replaced by the last non-missing score.|||Participants|||Count of Participants
2687842|NCT01338415|Primary|Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation|"This is the total number of subjects with at least one adverse event (serious or not serious) whether or not causally related to the study drug and presented cumulatively in the FUTURE 3 and FUTURE 3 Extension study.~NOTE: FUTURE 3 extension study was exploratory and no primary efficacy and safety endpoints were defined in the protocol. So, this safety outcome measure was selected and reported as primary endpoint here."|Up to 62 weeks in average|The analysis was performed on the Safety population analysis set, including all patients who received at least one dose of study treatment and evaluated according to the study treatment that they received.|||Participants|||Count of Participants
2687843|NCT01338298|Secondary|To Test Whether Adjunctive Aripiprazole Will Improve Quality/Perceived Quality of Life.|We will measure if patients' symptoms improve, improvement in their sexual dysfunction or distress and if they feel better with the elimination of the side effects. We hypothesize that aripiprazole will improve psychiatric symptoms, quality of life, sexual functioning and perceived wellness relative to placebo in women stabilized on risperidone (or paliperidone).|16 Weeks|14 of the 20 participants receiving Aripiprazole and 11 of the 18 participants receiving placebo reported sexual dysfunction at baseline.|||Participants|||Count of Participants
2687844|NCT01338298|Primary|To Determine if Adjunct Aripiprazole Will Resolve or Improve Prolactin Related Hormonal Side Effects (Amenorrhea, Oligomenorrhea, Galactorrhea).|We will assess this outcome by monitoring the return of menstruation and the elimination of lactation. We hypothesize that adjunct aripiprazole will resolve hormonal effects in women with symptomatic hyperprolactinemia stabilized on risperidone (or paliperidone).|16 Weeks|13 of the 20 Aripiprazole participants had lack of menstruation a the start of the study, and 11 of the 18 participants receiving placebo had lack of menstruation a the start of the study, therefore the analysis of return of menstruation is based on 24 participants.|||Participants|||Count of Participants
2687845|NCT01338025|Secondary|Number of Participants Non-adherent as Measured by 3-day Recall|Number of participants reporting a missed medication dose in the past 3 days.|28 Weeks|All eligible participants with adherence data available at week 28.|||participants|||Number
2687846|NCT01338025|Secondary|Change in HIV-1 RNA Levels|Change in HIV-1 RNA levels from Entry to Week 28|28 Weeks|All eligible participants with HIV-1 RNA results available at entry and at week 28.|||copies/mL||Inter-Quartile Range|Median
2687847|NCT01338025|Secondary|Change in CD4+ T Cell Count|Change in CD4+ T cell count from entry to Week 28 (CD4+ at entry - CD4+ at Week 28).|Entry to week 28|All eligible participants with CD4+ cell count results available at entry and at week 28.|||CD4+ T cell count/mL||Inter-Quartile Range|Median
2687848|NCT01338025|Primary|Number of Participants With Immunologic Deterioration|"Immunologic deterioration was declared for a participant if any one of the following conditions is observed within the first 28 weeks:~greater than or equal to 30% decline in absolute CD4+ T cell count from entry, or~development of CDC class C events.~Results report number of participants with immunologic deterioration at week 28 calculated."|From entry to week 28|All eligible participants who entered the study were included in analyses. One participant on Arm A did not meet entry eligibility criteria; was taken off study after the entry visit, and is therefore excluded from all analyses.|||participants|||Number
2687849|NCT01338012|Primary|Number of Study Participants Enrolled and Treated Prior to Study Termination|Number of study participants that were enrolled and treated in this trial following completion of study P-11 and prior to study termination.|Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015|This study was terminated early due to administrative reasons. Only eight subjects out of the ninety subjects planned were enrolled and treated. Given the small number of patients enrolled, results should be interpreted with caution.|||Participants|||Count of Participants
2687850|NCT01337986|Primary|Change From Baseline in Raw Letters by EDTRS 5% Contrast Sensitivity|Intent to treat analysis of treatment effect in primary endpoint EDTRS 5% Contrast Sensitivity. Change in the number of letters able to read while on Dalfampridine and Placebo relative to their baseline scores.|Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)|Intent To Treat Population, scores from morning and afternoon were averaged.|||letters||Standard Deviation|Mean
2687851|NCT01337986|Secondary|Difference in Pelli- Robson Score at Visits 2 and 3 Relative to Visit 1|Difference in Pelli- Robson Score at Visits 2 and 3 Relative to Visit 1 on Dalfampridine vs Placebo. Pelli-Robson is scored based upon the numbers read on the chart converted to LogMAR units. The scale is 0.00 (worst) to 2.35 (best).|Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)|per protocol|||units on a scale|Number of Eyes|Standard Deviation|Mean
2688124|NCT01335932|Secondary|Platelet Transfusions|Platelet transfusions per patient|by 35 days post-randomization||||transfusions||Inter-Quartile Range|Median
2687853|NCT01337986|Secondary|Changes in Color Vision Total Error Score From Baseline Based Upon the Farnsworth Munsell Hue 100 Sort Test (FM100).|Dalfampridine will change color vision Total Error Scores from baseline on the Farnsworth Munsell 100 Hue Sort Test. Farnsworth Munsell 100 Hue Test requires placing 100 color palettes in the correct order based upon color hue. Scores are determined by the frequency and severity of any displacement in the correct order. One error equates to one misplaced hue, by one step or position. An error score greater than 500 indicates virtually no color discrimination. An error score of 0 indicates no errors in ordering the hues. A Total Error Score of 0 to 128 could be seen in a normal population.|Visit 1 (Week 0 - baseline), Visit 2 (Week 3 - postintervention 1) and Visit 3 (Week 8 - post intervention 2)|per protocol|||FM100 Total Error Score||Full Range|Mean
2687854|NCT01337986|Secondary|Odds Ratio Quartile of Visual Field Index|"The Visual Field Index (VFI) is a global index that assigns a number between 1% to 100% based on an aggregate percentage of visual function, with 100% being a perfect age-adjusted visual field.~Probability of falling in the best quartile for visual field (VFI) measures (Q1), relative to the three next quartiles for worse VFIs (Q2-4), while on Dalfampridine vs Placebo. Due to the clustered observations at different times in a cross-over design, the visual field data is not suited to a normal theory model and should not be expressed as a continuous variable. Thus, a categorical model that uses a multinomial distribution for measurement of 4 categories was selected for proper statistical modeling, with results expressed as odds ratios."|Visit 1 (Week 0 - baseline), Visit 2 (Week 3 - post intervention 1) and Visit 3 (Week 8 - post intervention 2)||||Visual Field Index % of normal vision|eligible eyes|Standard Deviation|Mean
2687855|NCT01337986|Secondary|Visual Evoked Potential P100 Latency Per Treatment Arm|Visual evoked potential 60min P100 latency on dalfampridine vs. placebo.|Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)|per protocol|||milliseconds||Standard Deviation|Mean
2687856|NCT01337986|Secondary|Percentage of Eyes That Improved by One-line (5 Letters)|Percentage of eyes that improved by one-line (5 letters) on the 5% contrast sensitivity chart|Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)|Proportion as the Percent of Eyes Improved by 1 Line|||Percent of Eyes|Number of Eyes|95% Confidence Interval|Number
2687857|NCT01337986|Secondary|Percentage of Eyes That Improved by 2 Lines (10 Letters) on the Sloan 5% Contrast Sensitivity Chart||Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)||||Percentages of eyes that improved|Number of Eyes|95% Confidence Interval|Number
2687858|NCT01337986|Primary|Difference in EDTRS 5% Contrast Sensitivity (LogMAR Score) at Visits 2 and 3 Relative to Visit 1|Intent to treat analysis of treatment effect in primary endpoint EDTRS 5% Contrast Sensitivity. Improvement from baseline scores.|Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)|Intent To Treat Population, scores from morning and afternoon were averaged.|||5% Contrast LogMAR Score||Standard Deviation|Mean
2687859|NCT01337986|Primary|Efficacy of Dalfampridine on Visual Function Assessed by Change From Baseline in Raw Letters by EDTRS 5% Contrast Sensitivity|Per Protocol Analysis to assess difference in number of letters on the EDTRS 5% Contrast Sensitivity (LogMAR) Chart scores at visits 2 and 3 Relative to Visit 1|Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)|Per protocol analysis|||letters|eligible eyes|Standard Deviation|Mean
2687860|NCT01337986|Primary|Efficacy of Dalfampridine on Visual Function by Early Diabetic Treatment Retinopathy Study (EDTRS) 5% Contrast Sensitivity Scores|Per Protocol Analysis to assess differences in EDTRS 5% Contrast Sensitivity (LogMAR) Scores at visits 2 and 3 Relative to Visit 1 on patients taking Dalfampridine vs Placebo.|Visit 1 (Week 0), Visit 2 (Week 3) and Visit 3 (Week 8)|Per protocol analysis|||LogMAR Score|eligible eyes|Standard Deviation|Mean
2687861|NCT01337973|Secondary|Percent Change in the Percentage of Days of Substance Use for Each Substance|Data was collected via a Time-line Follow Back interview. Semi-structured interview assessing alcohol and drug use. Baseline data collection assessed the 180 days prior to enrollment, and follow-up data was collected at 3 and 6 months for the prior 90 days, and at 12 months for the past 180 days. The analysis below compares the monthly rate of various types of substance use (heavy drinking, cocaine, marijuana, and illicit) from the period pre-baseline to the monthly rate post-intervention (across all 12 months of follow-up) in the form of % difference. (% days use for each substance) Means at baseline, 3 , 6 and 12 months were compared resulting in a number with no measure of dispersion. Values were calculated across all participants.|% difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data|Main analyses used General Estimating Equations which accounts for missing data. Results in data table are from bivariate analyses.|||percentage of change|||Number
2687862|NCT01337973|Primary|Conflict Tactics Scale-Structured Interview (CTS-SI)|The CTS-SI is a semi-structured interview assessing interpersonal violence (violence severity, injury and characteristics of interpersonal conflict incidents). Baseline data collection assessed the 180 days prior to enrollment, and follow-up data was collected at 3 and 6 months for the prior 90 days, and at 12 months for the past 180 days. The analysis below compares the month rate of various types of interpersonal aggression from the period pre-baseline to the monthly rate post-intervention (across all 12 months of follow-up) in the form of % difference. Means at baseline, 3 , 6 and 12 months were compared resulting in a number with no measure of dispersion. Values were calculated across all participants. There were primary aggression outcomes (overall physical aggression, injuring another person), and secondary aggression outcomes (partner physical aggression and injury, nonpartner physical aggression and injury).|% difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data|Main analyses used General Estimating Equations which accounts for missing data. Results in tables below are from bivariate analyses.|||percentage change|||Number
2687863|NCT01337960|Secondary|Anticipatory Postural Adjustments|During gait initiation two force plates measure ground reaction forces and impulses for the postural shifts made in preparation to begin walking.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|These data were not collected due to technical issues.||||||
2687889|NCT01337609|Primary|Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)|The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)is a self report measure that addresses depressive symptoms. MDD responders will be defined as those exhibiting a 50% decrease in the QIDS SR at study endpoint.|Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.||||||
2707426|NCT01191242|Primary|Total Methadone Trough Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
2687864|NCT01337960|Secondary|Dynamic Gait Index|The Dynamic Gait Index (DGI) assesses individual's ability to modify balance while walking in the presence of external demands. Performed with a marked distance of 20 feet . The DGI can be performed with or without an assistive device. Scores are based on a 4-point scale: 3 = No gait dysfunction; 2 = Minimal impairment; 1 = Moderate impairment; 0 = Severe impairment. The highest possible score is 24 points. asks include: Steady state walking; Walking with changing speeds; Walking with head turns both horizontally and vertically; Walking while stepping over and around obstacles; Pivoting while walking; Stair climbing.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|Nonparametric Fisher's exact test was applied to compare between group changes at retention.|||units on a scale||Standard Error|Mean
2687865|NCT01337960|Secondary|Berg Balance Scale|14-item scale to assess balance function and fall risk, 56 is top score possible (0-56); higher scores indicate higher balance function. Items assess static and dynamic activities of varying difficulty; they are performed to evaluate global level of balance function. Item-level scores range from 0-4, determined by ability to perform the assessed activity; item scores are summed to create the overall score. Subscales are not analyzed.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|Nonparametric Fisher's exact test was applied to compare between group changes at retention.|||units on a scale||Standard Error|Mean
2687866|NCT01337960|Secondary|Gait Kinetics|Anterior-posterior and medio-lateral ground reaction forces during walking to assess propulsive impulses from paretic and nonparetic sides.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|Nonparametric Fisher's exact test was applied to compare between group changes at retention.|||Newton-seconds||Standard Error|Mean
2687867|NCT01337960|Primary|Self-selected Floor Walking Velocity Change From Baseline to Post-training and Retention|Velocity and associated spatio-temporal gait parameters from self-selected most comfortable and fastest floor walking over 10m.|Baseline, Post-test training at 6 weeks; Retention at 12 weeks (note TMO control has no retention period)|Nonparametric Fisher's exact test was applied to compare between group changes at retention.|||cm/sec||Standard Error|Mean
2687868|NCT01337739|Secondary|Time to Discharge|Time to discharge from the Post Anesthesia Care Unit or home or to hospital room.|24 Hours||||minutes||Standard Deviation|Mean
2687869|NCT01337739|Primary|The Primary Outcome Will be the Difference in Intraoperative Opioid (Fentanyl) Administration Between Patients Receiving Dexmedetomidine and Those Receiving Propofol.|The primary outcome will be the difference in intraoperative opioid (fentanyl) administration between patients receiving dexmedetomidine and those receiving propofol. As described by mean and standard deviation.|Interoperative period||||Total Morphine Equivalents mg||Standard Deviation|Mean
2687870|NCT01337700|Secondary|Change in Diagnostic Analysis of Nonverbal Activity-2 ADULT FACIAL EXPRESSIONS: (DANVA2-AF)|"This scale is shown to be sensitive to change in adults with autism, and related to amygdala function. Higher scores mean a better outcome.A clinical tool measuring emotion recognition through facial expression, voice and posture.~Child faces 2 (range 0 - 100, higher values reflecting higher % of errors)~Adult faces 2 (range 0 - 100, higher values reflecting higher % of errors)~Child paralanguage 2 (range 0 - 100, higher values reflecting higher % of errors)~Adult paralanguage 2 (range 0 - 100, higher values reflecting higher % of errors) Errors are counted and organized by pre-determined affect and intensity. Subtests considered separately."|baseline, weeks 2,4,6,8,10,12||||score on a scale||Standard Deviation|Mean
2687871|NCT01337700|Secondary|Change in Repetitive Behaviors Using YBOCS-Compulsion and Rigidity Subscale|"This scale has been shown to be a sensitive outcome measure in autism trials of repetitive behaviors. Data for secondary outcome not analyzed due to lack of significance in primary outcomes measured.~scale range: 0 - 40 total, 0 - 7 subclinical, 8-15 mild, 16 - 23 moderate, 24 - 31 severe, 32 - 40 extreme~score interpretation: Higher overall scores reflect increasing symptom severity."|baseline, weeks 2,4,6,8,10,12||||score on a scale||Standard Deviation|Mean
2687872|NCT01337700|Secondary|Change in Autism Severity Levels Based on the Clinical Global Impressions Scale|The CGI-I reflects the rater's impression of the subject's current autism severity on a 7-point scale ranging from Much Improved (1) to Much worse (5).|screening, baseline, weeks 2,4,6,8,10,12||||Participants|||Count of Participants
2687873|NCT01337700|Primary|Change in Hyperactivity as Measured by Aberrant Behavior Checklist - Hyperactivity Scale|"The Aberrant Behavior Checklist is an informant-based questionnaire consisting of 58 items subdivided amongst 5 scales: irritability, lethargy and social withdrawal, stereotypic behavior, hyperactivity/non-compliance, and inappropriate speech [34]. A score for each item ranges from 0 indicating no problem to 3 indicating severe problem. Scale scores are calculated by summing the items within that scale. Higher scores indicate greater impairment.Reported Data is for change in ABC-H from baseline to endpoint (week 0 to week 12).This data is specifically looking at the hyperactivity scale which is 16 items with each item ranging from 0-3 making total scores 0-48."|Baseline to Endpoint - 12 weeks||||units on a scale||Standard Deviation|Mean
2687874|NCT01337700|Primary|Change in Score on Conners Adults Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale|"Change will be measured in each subject's score on the Conners Adults Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale from baseline through study end (week 12).Higher values represent a worse outcome.~The raw scores are converted to T-scores for each scale and sub-scale which are then compared against the mean. Higher values represent a worse outcome. A T-score of 50 is the mean of a relevant reference population. A T-score above 65 indicates a moderate to severe problem. For example, Row 1 is the mean of baseline T-scores for the Inattention/ Memory subscale and Row 2 is the mean of week 12 T-scores for the Inattention/ Memory subscale. The difference between these two means is used to measure the change from baseline through week 12 for both the groups."|Baseline and Week 12 scores||||T-score||Standard Deviation|Mean
2687875|NCT01337687|Secondary|Change in Facial Emotion Recognition Based on Diagnostic Analysis of Nonverbal Accuracy - 2 (DANVA-2)|"A clinical tool measuring emotion recognition through facial expression, voice and posture.~Child faces 2 (range 0 - 100, higher values reflecting higher % of errors)~Adult faces 2 (range 0 - 100, higher values reflecting higher % of errors)~Child paralanguage 2 (range 0 - 100, higher values reflecting higher % of errors)~Adult paralanguage 2 (range 0 - 100, higher values reflecting higher % of errors) Errors are counted and organized by pre-determined affect and intensity. Subtests considered separately."|baseline, week 6||||units on a scale||Standard Deviation|Mean
2707427|NCT01191242|Primary|Total Methadone Peak Plasma Concentration||Day 1, Day 7, Day 21||||ng/mL||Standard Deviation|Mean
2687876|NCT01337687|Secondary|Change in Repetitive Behavior Based Repetitive Behavior Scale - Revised (RBS-R)|"Subscale ranges: stereotypic behavior (0 - 27);self-injurious behavior (0 - 24); compulsive behavior (0 - 18); ritualistic/Sameness Behavior (0 - 36); restricted Interests (0 - 9).~Higher score in all subscales reflect increasing severity. Questions rate behaviors on a 4-point scale: 0 = does not occur; 1 = occurs, mild problem; 2 = occurs, moderate problem; 3 = occurs, severe problem. Subscale scores consist of sum of ratings within each question subset.~Lower order behaviors-- stereotypy and self-injury, higher order behaviors--compulsions, rituals /sameness, restricted interests.~Lower Order total range: 0-51, Higher Order total range: 0-63 Stereotypic behavior and Self-injurious behavior subscales were summed to create a total range for Lower Order behavior; and Compulsive behavior, ritualistic /sameness behavior, and restricted interests subscales were summed to create a total range for Higher Order behavior."|Baseline, week 6||||score on a scale||Standard Deviation|Mean
2687877|NCT01337687|Secondary|Change in Obsessive- Compulsive Behavior Based on Yale Brown Obsessive Compulsive Scale (YBOCS)|"Clinician-Rated questionnaire measuring the time spent, distress,interference, resistance, and control in relation to obsessions and compulsions based on a 5 point scale ranging from 0-5 for each category with 0 being most desirable and 5 being least. Sub-scales are added and averaged to obtain total scores.~-scale range (total): 0 - 40 total, 0 - 7 subclinical, 8-15 mild, 16 - 23 moderate, 24 - 31 severe, 32 - 40 extreme~Questions are rated on a 5-point scale, 0-4, increasing in severity. Obsession Rating Subscale (5 questions, ranging from 0 - 20 total) and Compulsion Rating subscale (5 questions, ranging from 0 - 20 total) are totaled and added to obtain total scores.~-score interpretation: Higher overall scores reflect increasing symptom severity."|Baseline, Week 6||||score on a scale||Standard Deviation|Mean
2687878|NCT01337687|Primary|Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale|Rating Scale that utilizes direct observation, scales and patient report to inform clinical judgment. A form of CGI that targets social functioning will be used as the primary outcome measure. Semi-structured interview.|6 Weeks|Participants rated as improved on the CGI-I scale|||Participants|||Count of Participants
2687879|NCT01337674|Secondary|Steady-state Area Under the Plasma Concentration Versus Time Curve (AUC0-24hr) for MK-4618|Blood samples were collected on Day 7 predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours postdose for the determination of plasma MK-4618 concentration. The hypothesis for this outcome is that the steady-state AUC0-24hr for MK-4618 is >=0.47 uM*hr.|Predose and up to 24 hours postdose on Day 7|The Per Protocol population included participants who complied with the protocol sufficiently to ensure that the data will likely exhibit the effects of treatment, according to the underlying scientific model.|||uM*hr||90% Confidence Interval|Geometric Mean
2687880|NCT01337674|Primary|Maximum Change From Baseline in Semi-recumbent and Standing Systolic Blood Pressure: Panel B|Semi-recumbent and standing systolic blood pressure was measured predose and at intervals up to 24 hours postdose on Day 1 and Day 7. The baseline value is the average of measurements taken in the hour before dosing. Participants were to rest quietly in a semi-recumbent position for at least 10 minutes before each semi-recumbent measurement.|Baseline (predose) and up to 24 hours postdose on Day 1 and Day 7|The All Subjects as Treated population included all participants who received >=1 dose of study drug.|||mmHg||95% Confidence Interval|Mean
2687881|NCT01337674|Primary|Maximum Change From Baseline in Semi-recumbent and Standing Systolic Blood Pressure: Panel A|Semi-recumbent and standing systolic blood pressure was measured predose and at intervals up to 24 hours postdose on Day 1 and Day 7. The baseline value is the average of measurements taken in the hour before dosing. Participants were to rest quietly in a semi-recumbent position for at least 10 minutes before each semi-recumbent measurement.|Baseline (predose) and up to 24 hours postdose on Day 1 and Day 7|The All Subjects as Treated population included all participants who received >=1 dose of study drug.|||mmHg||95% Confidence Interval|Mean
2687882|NCT01337674|Primary|Percentage of Participants With a Clinical or Laboratory Adverse Experience|An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product is also an adverse experience. The percentage of participants with a clinical or laboratory adverse experience was recorded.|Up to 42 days|The All Subjects as Treated population included all participants who received >=1 dose of study drug|||Percentage of participants|||Number
2687883|NCT01337635|Secondary|Time to Restart Topical Steroids|The time to restart topical steroids.|6 weeks||||days||Full Range|Mean
2687884|NCT01337635|Primary|Atopic Dermatitis Severity at the Completion of Treatment|SCORAD at the 6 week study visit. The SCORAD (SCORing Atopic Dermatitis) is a clinical tool used to assess the extent and severity of eczema. The SCORAD is scored 0-103, with a higher score indicating more severe atopic dermatitis (worse outcome).|6 weeks||||score on a scale||Full Range|Mean
2687885|NCT01337609|Secondary|Patient Global Impression of Change (PGI-C) - IBS Symptoms|The PGI-C is a self-administered measure of the degree of improvement in IBS symptoms compared to the first study visit. Degree of improvement in IBS symptoms from first to final visit will be assessed using this scale.|Administered at each of 8 visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.||||||
2687886|NCT01337609|Secondary|Adequate Relief of IBS Pain (AR-IBS)|The AR-IBS is a self-administered measure of the adequacy of the relief of IBS pain.|Adminstered at each of 8 visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.||||||
2687887|NCT01337609|Secondary|Visual Analog Scale (VAS)|The VAS is a self-administered measure of abdominal pain, discomfort, and bloating. The change in total score from baseline to study endpoint will be assessed.|Administered at each of 8 study visits (every 10 days), Endpoint is Final Visit|Because the study sponsor chose to discontinue funding for this protocol following a change in leadership, the study was terminated early and this outcome measure was not analyzed.||||||
2687890|NCT01337596|Secondary|Multiple Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC)||Day 43 up to Day 57|PK Population: All participants who received multiple dose LY2951742 study drug with interpretable PK data.|||ng*day/mL||Geometric Coefficient of Variation|Geometric Mean
2687892|NCT01337596|Secondary|Single Dose Pharmacokinetics of LY2951742 Area Under the Curve (AUC)||Day 1 up to Day 84 or early discontinuation|PK Population: All participants who received single dose LY2951742 study drug with interpretable PK data.|||nanogram*day per milliliter (ng*day/mL)||Geometric Coefficient of Variation|Geometric Mean
2687893|NCT01337596|Secondary|Single Dose Pharmacokinetics of LY2951742 Maximal Concentration (Cmax)||Day 1 up to Day 84 or early discontinuation|Pharmacokinetic (PK) Population: All participants who received single dose LY2951742 study drug with interpretable PK data.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2687894|NCT01337596|Primary|Number of Participants With Clinically Significant Effects|Clinically significant effects were defined as serious and other non-serious adverse events (AEs). A summary of serious and all other non-serious AEs is located in the Reported Adverse Events module.|Baseline up to 6 months (study completion)|Safety Population: All participants who received at least 1 dose of the study drug.|||participants|||Number
2687895|NCT01337336|Secondary|Number of the Indicated COPD-related Exacerbations|The number of COPD-related exacerbations was identified during the follow-up period. Five types of COPD-related exacerbations were defined: -COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, combined occurrence of COPD-related hospitalization/ER visit, or combined occurrence of any COPD-related exacerbation. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.|Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)|Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date).|||number of exacerbations||Standard Deviation|Mean
2687896|NCT01337336|Secondary|Mean Annual COPD-related Costs Per Participant|Cost categories included medical, pharmacy, and total (calculated as the sum of medical and pharmacy). COPD-related medical costs were computed using claims with a primary diagnosis of COPD, and COPD-related pharmacy costs were computed using the paid amounts of pharmacy claims for prescription medication used for COPD.The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.|Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)|Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date).|||United States (US) dollars||Standard Deviation|Mean
2687897|NCT01337336|Secondary|Number of Participants With the Indicated COPD-related Exacerbations|The number of participants with a COPD-related exacerbation was identified during the follow-up period. Four types of COPD-related exacerbations were defined: COPD-related hospitalization, ER visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 5 days of the visit, or combined occurrence of COPD-related hospitalization/ER visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.|Maximum of 1 year after index date (January 1, 2004 through June 30, 2009)|Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintanance medication for COPD (index date).|||participants|||Number
2687898|NCT01337336|Primary|Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation|The number of participants with any of the following COPD-related exacerbations during the follow-up period was computed: COPD-related hospitalization, emergency room (ER) visit, or physician visit with a prescription (Rx) for oral corticosteroid (OCS) or antibiotic within 5 days of the visit. The index date is defined as the date of first chronologically occurring COPD maintenance medication of interest during an identification period spanning January 1, 2004 to June 30, 2008.|Maximum of 1 year after index date (January 1, 2004 to June 30, 2009)|Managed care enrollees (aged >=40 years) diagnosed with COPD (ICD code 491.xx, 492.xx, and 496.xx) and depression/anxiety before or within 60 days of the date of first prescription for a maintenance medication for COPD (index date).|||participants|||Number
2687899|NCT01337297|Secondary|State of Depression|It will be applied Hamilton Scale for Depression, a structured multiple choice questionnaire used to assess the severity of the symptoms of depression. It will be applied with cognitive tests.|Before the first experimental session, in the middle of the treatment and after the last experimental session.|||||||
2687900|NCT01337297|Secondary|Cognitive Tests|Cognitive tests are comprised by frontal assessment battery (FAB), Mini-Mental Status Examination (MMSE), verbal n-back task, visuospatial n-back task, go/no-go test.|Before the first experimental session, in the middle of the protocol and two days after the last experimental session|||||||
2687901|NCT01337297|Secondary|Event Related Potentials|Event Related Potentials (ERPs) elicited by random presentation of three related images and three non-related images to crack use every Monday and Friday over the two-weeks period of active-tDCS or sham-tDCS.|twice a week over two consecutive weeks during the treatment|||||||
2687902|NCT01337297|Secondary|Intensity of the Urge to the Use of Crack-cocaine|The intensity of craving will be examined by a short scale, the Brief Cocaine Craving Questionnaire.|before and after ERP in two weekly sessions over two weeks|||||||
2687903|NCT01337297|Primary|Abstinence|abstinence to the use of crack-cocaine up to 3 months after the completion of two-weeks of treatment sessions with active-tDCS or sham-tDCS.|Two days after the end of tDCS treatment (one session every other day, 5 sessions), that is, on the 12nd day from the beginning.||||percentage of participants|||Number
2687904|NCT01337167|Secondary|Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion|The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.|Up to 181 days after any infant vaccination (up to 12 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.|||Percentage of participants|||Number
2688125|NCT01335932|Secondary|Red Blood Cell Transfusions Required Per Patients|Red blood cell transfusions required per patients by day 35|by 35 days post-randomization||||transfusions||Inter-Quartile Range|Median
2687905|NCT01337167|Secondary|Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion|The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.|Up to 15 days after any infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.|||Percentage of participants|||Number
2687906|NCT01337167|Secondary|Percentage of Participants With Elevated Temperature by Severity|Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was >=38.0°C.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up and temperature data.|||Percentage of participants|||Number
2687907|NCT01337167|Secondary|Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug|Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.|Up to 5 days after each infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.|||Percentage of participants|||Number
2687908|NCT01337167|Secondary|Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug|Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.|||Percentage of participants|||Number
2687909|NCT01337167|Secondary|Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions|Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying abnormal, Somnolence, Decreased appetite, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, >5 cm. Grade 3 Solicited systemic reactions: Pyrexia, >=39.5°C (>=103.1°F) rectal; Vomiting, >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, Refuses >=3 feeds or refuses most feeds; Irritability, Inconsolable.|Up to 5 days after any infant vaccination (up to 6 months)|Participants included in these analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.|||Percentage of participants|||Number
2687910|NCT01337167|Secondary|Geometric Mean Concentration of Immunoglobulin A (IgA) Antibodies to Rotavirus|Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent assay for IgA antibodies to rotavirus.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||units/mL||95% Confidence Interval|Geometric Mean
2687911|NCT01337167|Secondary|Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen|Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||μg/mL||95% Confidence Interval|Geometric Mean
2687912|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||EU/mL||95% Confidence Interval|Geometric Mean
2687913|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||EU/mL||95% Confidence Interval|Geometric Mean
2687914|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||EU/mL||95% Confidence Interval|Geometric Mean
2687915|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||EU/mL||95% Confidence Interval|Geometric Mean
2687916|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||Percentage of participants||95% Confidence Interval|Number
2687917|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||Percentage of participants||95% Confidence Interval|Number
2687918|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||Percentage of participants||95% Confidence Interval|Number
2687919|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 4 (Month 16)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.|||Percentage of participants||95% Confidence Interval|Number
2687920|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||EU/mL||95% Confidence Interval|Geometric Mean
2687921|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||EU/mL||95% Confidence Interval|Geometric Mean
2687922|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||EU/mL||95% Confidence Interval|Geometric Mean
2687923|NCT01337167|Primary|Geometric Mean Concentration of Antibodies to Pertussis Toxin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL).|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||EU/mL||95% Confidence Interval|Geometric Mean
2687924|NCT01337167|Primary|Percentage of Participants Responding to Poliovirus Type 3|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687925|NCT01337167|Primary|Percentage of Participants Responding to Poliovirus Type 2|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687926|NCT01337167|Primary|Percentage of Participants Responding to Poliovirus Type 1|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer >=8.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687927|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Fimbriae|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687940|NCT01337089|Secondary|Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)|"The Patient Satisfaction Questionnaire (PSQ) was used to assess level of satisfaction of the participant with the study drug, with the markers extremely satisfied, very satisfied, slightly satisfied, neutral, slightly dissatisfied, very dissatisfied, extremely dissatisfied. Last visit refers to the last visit that a participant completed the assessment."|Last Visit (up to Day 183)|The Safety Population included all participants receiving at least 1 dose of study drug.|||Participants|||Count of Participants
2687928|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Pertactin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687929|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin|Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687930|NCT01337167|Primary|Percentage of Participants Responding to Pertussis Toxin|Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687931|NCT01337167|Primary|Percentage of Participants Responding to Tetanus Toxin|Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer >=0.1 IU/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687932|NCT01337167|Primary|Percentage of Participants Responding to Diphtheria Toxin|Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer >=0.1 International unit (IU)/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687933|NCT01337167|Primary|Percentage of Participants Responding to Hepatitis B Surface Antigen|Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer >=10 milli International units (mIU)/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687934|NCT01337167|Primary|Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen|Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for titer >=0.15 μg/mL and >=1.0 μg/mL.|Postdose 3 (Month 7)|The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.|||Percentage of participants||95% Confidence Interval|Number
2687935|NCT01337115|Primary|VAS Results - Pain Scores Measured in mm (0-100)|"VAS pain scores are measured by blinded investigators 24h after surgery .~VAS scale:~0 - no pain 100 - worst possible pain"|24h after surgery|In the CFNB group 2 patients did not complete the protocol. Analysis was made in an ITT manner and Last Observational Carried Forward (LOCF) was the imputation technique used. In the SNB group, all 25 patients completed the protocol|||units on a scale||Standard Deviation|Mean
2687936|NCT01337115|Primary|VAS Results - Pain Measured in mm (0-100)|"VAS pain scores are measured by blinded investigators 12h after surgery .~VAS scale:~0 - no pain 100 - worst possible pain"|12h after surgery|All 25 patients in each arm completed the protocol. Analysis was made in an ITT manner.|||units on a scale||Standard Deviation|Mean
2687937|NCT01337115|Secondary|Satisfaction With Anesthesia Technique in Each Arm of the Study|"Satisfaction with the anesthesia technique using a categorical scale with three levels:~Bad Reasonable Good/Very Good A Fisher's Exact test is made to asses any differences in the distribution of patients in each arm to each level of the categorical scale"|1 month after surgery|Analysis was performed on Participants available for telephone contact one month after surgery and was made per protocol.|||participants|||Number
2687938|NCT01337115|Primary|Visual Analogue Scores (VAS) - Pain Scores Measured in mm (0-100)|Pain scores measured by Visual Analogue Score (VAS) scale at 15-30min after Post anesthesia care unit (PACU) arrival VAS is a 100mm scale to measure pain. 0mm - no pain 100mm - worst possible pain|15-30 min after arrival on post anesthesia care unit (PACU)|Participants were analyzed in an Intention to treat (ITT) manner. All randomized subjects (25 in each arm) completed the protocol so all were included for analysis as planned.|||units on a scale||Standard Deviation|Mean
2687939|NCT01337089|Secondary|Change From Baseline In NRS Constipation At Last Visit (Up To Day 183)|"Participants indicated level of constipation on an 11-point NRS, where a score of 0 was no constipation, and 10 was constipation as bad as you can imagine. Last visit refers to the last visit that a participant completed the assessment.~Change in NRS constipation score was calculated as: Last Visit NRS constipation score - Baseline NRS constipation score.~A negative value indicates improvement in condition from Baseline."|Baseline, Last Visit (up to Day 183)|The Safety Population included all participants receiving at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2710799|NCT01167829|Secondary|Free Testosterone Mean Concentration|Free T normal range 4.7-18 ng/dL|baseline & day 9|per protocol|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
2687941|NCT01337089|Secondary|Change From Baseline In Mean Sleep Disruption NRS During The Last Period|"Participants indicated the level of sleep disruption experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated did not disrupt sleep and a score of 10 indicated completely disrupted (unable to sleep at all). Change in mean sleep disruption NRS was calculated as: Last Period sleep disruption NRS score - Baseline sleep disruption NRS score.~A negative value indicates an improvement in sleep disruption score from Baseline."|Baseline, Last Period (Days 156-183) or last 27 days of treatment|The Safety Population included all participants receiving at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2687942|NCT01337089|Secondary|Change From Baseline In Mean NRS Average Pain During The Last Period|"Participants indicated the level of pain experienced in the last 24 hours on an 11-point Numerical Rating Scale (NRS), where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Change in mean NRS average pain was calculated as: Last Period NRS average pain score - Baseline NRS average pain score.~A negative value indicates an improvement in average pain score from Baseline."|Baseline, Last Period (Days 156-183) or last 27 days of treatment|The Safety Population included all participants receiving at least 1 dose of study drug.|||units on a scale||Standard Deviation|Mean
2687943|NCT01337089|Primary|Percent Of Participants With Treatment-emergent Adverse Events|Treatment-emergent Adverse Events (TEAEs) were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) dictionary version 17.0. A TEAE is defined as an adverse event with an onset after the start of study drug treatment. The percent of participants who experienced one or more TEAEs is reported.|Baseline, Day 183|The Safety Population included all participants receiving at least 1 dose of study drug.|||percent of participants|||Number
2687944|NCT01337076|Primary|CNC Monosyllabic Word Score - Treated Ear|"The primary study endpoint was to test whether a statistically significant difference could be obtained between the mean, preoperative Consonant Nucleus Consonant (CNC) monosyllabic word score in the ear to be implanted compared to the postoperative CNC word score in the cochlear implant alone condition at 6 months postimplant activation for candidates who currently perform outside the approved Nucleus® cochlear implant candidacy requirements.~CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet."|Six months||||percent correct||Full Range|Mean
2687945|NCT01337050|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. PFS calculated as (Months) = (first event date minus randomization or the first dose date plus 1) divided by 30.44). PFS was calculated using the median, and 95% Confidence Intervals (CIs) and Progressive disease (PD):>=20% (>= 5 mm increase) increase sum of LD of TL taking as a reference smallest sum of LD recorded since treatment start, appearance of >=1 new lesions, unequivocal progression of existing non-TL, or appearance of >=1 new lesion.|Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)|Response evaluable population included all enrolled participants with measurable disease who received at least 1 dose of PF-03446962 and had an adequate baseline tumor assessment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||months||95% Confidence Interval|Median
2687946|NCT01337050|Secondary|Number of Participants With Clinical Benefit Response (CBR)|Number of participant with clinical benefit response (CBR): CBR was defined as CR, PR, SD >12 weeks, SD<12weeks or PD according to RECIST criteria; Complete response (CR): disappearance of all lesions, Pathological lymph nodes' reduction in short axis (SA) to <10 mm; Partial response (PR): >=30% decrease in sum of longest dimensions (LD) of Target Lesions (TL) taking reference baseline sum LD; Progressive disease (PD):>=20% (>= 5 mm increase) increase sum of LD of TL taking as a reference smallest sum of LD recorded since treatment start, appearance of >=1 new lesions, unequivocal progression of existing non-TL, or appearance of >=1 new lesion; Stable disease (SD): insufficient shrinkage to qualify for PR, insufficient increase to qualify for PD taking reference smallest sum of the LD since treatment start.|Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)|Response evaluable population included all enrolled participants with measurable disease who received at least 1 dose of PF-03446962 and had an adequate baseline tumor assessment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2687947|NCT01337050|Secondary|Number of Participants With Best Overall Response (BOR)|Number of participants with best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST); Complete response (CR): disappearance of all lesions, Pathological lymph nodes' reduction in short axis (SA) to less than (<)10 millimeter (mm); Partial response (PR): greater than equal to (>=) 30% decrease in sum of longest dimensions (LD) of Target Lesions (TL) taking reference baseline sum LD; Progressive disease (PD):>=20% (>= 5 mm increase) increase sum of LD of TL taking as a reference smallest sum of LD recorded since treatment start, appearance of >=1 new lesions, unequivocal progression of existing non-TL, or appearance of >=1 new lesion; Stable disease (SD): insufficient shrinkage to qualify for PR, insufficient increase to qualify for PD taking reference smallest sum of the LD since treatment start. Confirmed response=that persist at least 4 weeks after initial documentation.|Baseline, thereafter every 6 weeks up to end of treatment (up to Cycle 30)|Response evaluable population included all enrolled participants with measurable disease who received at least 1 dose of PF-03446962 and had an adequate baseline tumor assessment. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||participants|||Number
2687948|NCT01337050|Secondary|Number of Participants With Human Anti-Human Antibody (HAHA)|HAHA analysis was performed using validated, sensitive and specific chemiluminescence enzyme-linked immunosorbent assay (ELISA) methodology.|Baseline, Post-dose (Day 1 of every Cycle up to 28 days after last dose) up to Cycle 30|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||participants|||Number
2687960|NCT01337050|Secondary|Number of Participants With Treatment Emergent Adverse Events (AEs) Based on Severity|Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; Grade 1 (Mild Adverse Event), Grade 2 (Moderate Adverse Event), Grade 3 (Severe Adverse Event), Grade 4 (Life- Threatening or Disabling Adverse Event), Grade 5 (Death Related to Adverse Event).|Baseline up to 28 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||participants|||Number
2687949|NCT01337050|Secondary|Soluble Proteins Level|Soluble proteins related to Activin Receptor-Like Kinase 1 (ALK-1) signaling and angiogenesis signaling including Vascular adhesion molecule (VAM), Monocyte chemotactic protein 1 (MCP-1), Angiopoietin 2, Tear intercellular adhesive molecule 1 (ICAM-1), Soluble intracellular adhesion molecule 1 (SIAM-1), Soluble vascular adhesion molecule 1 (SVAM-1), Vascular endothelial growth factor A (VEGF-A), Vascular endothelial growth factor C (VEGF-C), Vascular endothelial growth factor D (VEGF-D), Soluble vascular endothelial growth factor- Receptor 1 (REC 1) (SVEGF-REC 1), Soluble vascular endothelial growth factor- REC 2 (SVEGF-REC 2), Soluble vascular endothelial growth factor- REC 3 (SVEGF-REC 3), Bone morphogenetic protein-9 (BMP-9), Endoglin, Transforming growth factor- beta 1 (TGF- Beta 1), Placental growth factor (PGF) was evaluated.|Baseline, Day 1, 0 hour (H), 6 H Cycle 1 Day 1, Day 22 of Cycle 1, Day 1 Cycle 2, Day 1 Cycle 3 and end of treatment (up to cycle 30)|Biomarker analysis population included all enrolled and treated participants with baseline and on-treatment biomarker sample analyzed. Here “n”= participants who were evaluable for specified biomarker at given time point for each arm, respectively.|||picogram per milliliter (pg/mL)||Standard Deviation|Mean
2687950|NCT01337050|Secondary|Plasma Decay Half-Life (t1/2)|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||days||Standard Deviation|Mean
2687951|NCT01337050|Secondary|Volume of Distribution (Vd)|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||liter (L)||Geometric Coefficient of Variation|Geometric Mean
2687952|NCT01337050|Secondary|Systemic Clearance (CL)|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||liter per hour (L/hr)||Geometric Coefficient of Variation|Geometric Mean
2687953|NCT01337050|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)|Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) for drug.|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest.|||ng*hr/mL||Geometric Coefficient of Variation|Geometric Mean
2687954|NCT01337050|Secondary|Area Under the Curve From Time Zero to 28 Days [AUC (0-28)]|AUC (0-28)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-28).|0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||nanogram*hour per milliliter (ng*hr/mL)||Geometric Coefficient of Variation|Geometric Mean
2687955|NCT01337050|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax)||0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest.|||hours (hr)||Full Range|Median
2687956|NCT01337050|Secondary|Minimum Observed Serum Trough Concentration (Cmin)||0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|PK parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2687957|NCT01337050|Secondary|Maximum Observed Serum Concentration (Cmax)||0 (pre dose), 0.5, 1 (right before the end of infusion), 1.5, 2, 5, 8, 24 hours after the start of infusion of the first dose on Day 1; Day 3, 5, 8, 11, 15, 22 of Cycle 1|Pharmacokinetic (PK) parameter analysis population included all participants treated who had at least 1 of the PK parameters of interest.|||nanogram per milliliter (ng/mL)||Geometric Coefficient of Variation|Geometric Mean
2687958|NCT01337050|Secondary|Number of Participants With Laboratory Abnormalities|Laboratory abnormalities were segregated into hematology, chemistry, coagulation and urinalysis test. It had been graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) into Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Life-threatening). Participants with abnormality of any of these grades are reported.|Baseline up to 28 days after last dose|Safety analysis set included all participants who received at least 1 dose of study medication.|||participants|||Number
2687959|NCT01337050|Secondary|Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious adverse events (non-SAEs). Relatedness to study drug was assessed based on investigator's discretion.|Baseline up to 28 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||participants|||Number
2688126|NCT01335932|Secondary|Renal Insufficiency|Number of patients experiencing a glomerular filtration rate < 60mL/min at day 35|by 35 days post-randomization||||Participants|||Count of Participants
2687961|NCT01337050|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-serious adverse events (non-SAEs).|Baseline up to 28 days after last dose|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||participants|||Number
2687962|NCT01337050|Primary|Recommended Phase-2 Dose (RP2D)|RP2D was determined by a comprehensive assessments based on all the safety data, efficacy data, pharmacokinetics profile and biomarker data using blood and tumor samples.|Baseline up to 28 days after last dose of study medication|Safety analysis set included all enrolled participants who received at least 1 dose of study medication.|||mg/kg|||Number
2687963|NCT01337050|Primary|Maximum Tolerated Dose (MTD)|The MTD was defined as the highest dose of PF-03446962 associated with the occurrence of Dose Limiting Toxicities (DLTs) in at most 1 of 6 participants with the next higher dose having at least 2/3 or 2/6 participants experiencing DLTs (that is (i.e.) Maximum Administrated Dose). DLT is defined if the participants meets the following criteria during the first 6 weeks of treatment, possibly attributable to PF-03446962. Neutropenia grade 4 (less than [< ])500/cubic millimeter [mm^ 3]) lasting for greater than equal to (>=) 8 days; Febrile Neutropenia >= Grade 3; Neutropenic Infection >= Grade 3; Grade 4 thrombocytopenia (<25,000/mm^3); Grade 3 thrombocytopenia (<50,000/mm^3) with active bleeding; Grade 3 or higher non-hematological toxicity.|Baseline up to Week 6|Safety analysis set included all enrolled participants who received at least 1 dose of study medication. Here “N” (number of participants analyzed) signifies participants who were evaluable for this measure.|||mg/kg|||Number
2687964|NCT01336972|Secondary|Mean Change From Baseline in 2 Hour Urine Volume After 3 Weeks Tolvaptan Treatment and at 3 Weeks Post Treatment.|The volume of urine from each 2-hour urine collection in the renal function tests at Baseline, Final Treatment, and Post Treatment was recorded. Individual voids in a collection interval were pooled before determination of total volume.|2 hours|All participants who took any trial medication and had a postbaseline renal function test.|||mL||Standard Deviation|Mean
2687965|NCT01336972|Secondary|Mean Change From Baseline in 24 Hour Urine Volume After 3 Weeks Tolvaptan Treatment and at 3 Weeks Post Treatment.|A 24-hour split urine sample (approximate times: 0700 to 1700 hours, 1700 hours to bedtime, and bedtime to 0700 hours) was collected beginning the day before the Baseline, Final Treatment, and Post Treatment visits and ending at admission to the renal function ward. Individual voids in a collection interval were pooled and the total volume determined.|24 hours|All participants who took any trial medication and had a postbaseline renal function test.|||mL||Standard Deviation|Mean
2687966|NCT01336972|Secondary|Percentage Change From Baseline in Total Kidney Volume (TKV) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.|TKV was measured using magnetic resonance imaging.|After 3 weeks of treatment and 3 weeks post treatment|All participants who took any trial medication and had a postbaseline renal function test.|||Percent||Standard Deviation|Mean
2687967|NCT01336972|Secondary|Area Under the Concentration-time Curve From 0 to 5 Hours (AUC0-5) After 3 Weeks of Tolvaptan Treatment.|"Blood sampling for determination of tolvaptan concentrations took place at the Baseline, Final Treatment, and the Post Treatment or Early Termination visits.~At the Final Treatment visit (Day 21 [+/- 1 day)]), blood samples were collected prior to the start of infusion of study treatment and at 1, 2, 3, 4, and 5 hours postdose.~At the Baseline (Day 0), and Post Treatment visit (3 weeks [+/-3 days] after last dose), a blood sample was collected prior to the start of infusion of study treatment."|Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hour|All participants who took any trial medication and had a postbaseline renal function test.|||ng.h/mL||Standard Deviation|Mean
2687968|NCT01336972|Secondary|Time to Peak Plasma Concentration (Tmax) After 3 Weeks of Tolvaptan Treatment.|"Blood sampling for determination of tolvaptan concentrations took place at the Baseline, Final Treatment, and the Post Treatment or Early Termination visits.~At the Final Treatment visit (Day 21 [+/- 1 day)]), blood samples were collected prior to the start of infusion of study treatment and at 1, 2, 3, 4, and 5 hours postdose.~At the Baseline (Day 0), and Post Treatment visit (3 weeks [+/-3 days] after last dose), a blood sample was collected prior to the start of infusion of study treatment."|Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hour|All participants who took any trial medication and had a postbaseline renal function test.|||hours||Full Range|Median
2687969|NCT01336972|Secondary|Time to Peak Plasma Concentration (Cmax) After 3 Weeks of Tolvaptan Treatment.|"Blood sampling for determination of tolvaptan concentrations took place at the Baseline, Final Treatment, and the Post Treatment or Early Termination visits.~At the Final Treatment visit (Day 21 [+/- 1 day)]), blood samples were collected prior to the start of infusion of study treatment and at 1, 2, 3, 4, and 5 hours postdose.~At the Baseline (Day 0), and Post Treatment visit (3 weeks [+/-3 days] after last dose), a blood sample was collected prior to the start of infusion of study treatment."|Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hour|All participants who took any trial medication and had a postbaseline renal function test.|||ng/mL||Standard Deviation|Mean
2687970|NCT01336972|Secondary|Mean Change From Baseline in Free Water Clearance After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment|Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours).|After 3 weeks of treatment and 3 weeks post treatment|All participants who took any trial medication and had a postbaseline renal function test.|||mL/min||Standard Deviation|Mean
2687971|NCT01336972|Primary|Mean Change From Baseline in Filtration Fraction (GFR/ERFP) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.|Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours).|After 3 weeks of treatment and 3 weeks post treatment|All participants who took any trial medication and had a postbaseline renal function test.|||Ratios||Standard Deviation|Mean
2687972|NCT01336972|Primary|Mean Change From Baseline in Effective Renal Plasma Flow (ERPF) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.|Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours).|After 3 weeks of treatment and 3 weeks post treatment|All participants who took any trial medication and had a postbaseline renal function test.|||mL/min||Standard Deviation|Mean
2687973|NCT01336972|Primary|Mean Change From Baseline in Measured Glomerular Filtration Rate (mGFR) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.|Renal function measurements were performed using the constant infusion method with 125I-iothalamate and 131I-hippuran. A priming solution containing 20 mL infusion solution (0.04 MBq of 125I-iothalamate and 0.03 MBq of 131I-hippuran) was given at 08:00 hours, followed by a constant infusion of 6 to 12 mL/h, with the lowest infusion rates in subjects with impaired renal function, based on previously known serum creatinine concentrations. Plasma concentrations of both tracers were allowed to stabilize during a 1.5-hour equilibration, which was followed by two 2-hour periods (09:30 to 11:30 hours and 11:30 to 13:30 hours) for simultaneous clearances of 125I-iothalamate and 131I-hippuran. Blood was drawn at 1, 2, 3, 4, and 5 hours post consumption of water/tolvaptan (08:30 hours). The mGFR was corrected for voiding errors.|After 3 weeks of treatment and 3 weeks post treatment|All participants who took any trial medication and had a postbaseline renal function test.|||mL/min||Standard Deviation|Mean
2687974|NCT01336959|Secondary|Pharmacokinetic Measurements of Drug in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass Pump. Pharmacokinetics Will be Measured Using Cmax|Max serum concentration reached (ng/mL)|4 days|PK Analysis Set|||ng/mL||Standard Deviation|Mean
2687975|NCT01336959|Primary|Renal Function Measured at 48 Hours Post Cardiac Surgery With Cardiopulmonary Bypass Pump.|Median percent change from baseline in estimated Glomerular Filtration Rate (eGFR) at 48 hours postdose.|48 hours|Full Analysis Set|||Median percentage change||5% Confidence Interval|Median
2687976|NCT01336933|Secondary|Percent of Patients Who Proceeded With Transplant|Percentage of patients who received consolidation with high dose therapy and autologous stem cell rescue (HDT/SCR).|168-252 days (4 courses up to 6 courses of treatment)|Thirty-three patients were analyzed. One patient withdrew consent before starting therapy.|||Participants|||Count of Participants
2687977|NCT01336933|Secondary|To Evaluate the Safety and Tolerability of the Regimen by the Percent of Participants With Indicated Adverse Events|Adverse events will be summarized using patient level incidence rates so that a patient contributes once to any adverse event. The number and percentage of patients with any adverse event will be summarized for each course. Serious adverse events will be analyzed similarly.|22 months|All eligible patients who received at least one cycle of chemotherapy were evaluable for toxicity.|||percentage of participants|||Number
2687978|NCT01336933|Secondary|Overall Survival (OS)|Estimated 2-year Overall Survival (OS), as well as plots of OS, will be produced using the method of Kaplan-Meier, along with 95% confidence intervals for OS. Overall survival is defined as time from the first chemotherapy administered on trial until death from any cause.|2 years|All evaluable patients irrespective of the total number of cycles of therapy received were included in EFS and OS analyses.|||percentage of participants analyzed||95% Confidence Interval|Number
2687979|NCT01336933|Secondary|Event Free Survival (EFS)|Estimated 2-year Event Free Survival (EFS), as well as plots of EFS, will be produced using the method of Kaplan-Meier, along with 95% confidence intervals for EFS. Event-free survival is defined as time from therapy until relapse, progression, or death from any cause.|2 years|All evaluable patients irrespective of the total number of cycles of therapy received were included in the EFS and OS analyses.|||percentage of participants analyzed||95% Confidence Interval|Number
2687980|NCT01336933|Secondary|Overall Response Rates (ORR)= (Complete Response Rates (CR) + Partial Response Rates (PR))|"Every patient who fulfills all aspects of patient eligibility who receives at least 2 complete courses of chemotherapy will be evaluable for the response endpoint. Response rates will be descriptively summarized using percentages and 95% confidence intervals.~Complete Response Definition: Defined in Primary Objective Partial Response Definition: Regression of measurable disease and no new sites, Nodal Masses: > 50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes~FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site~Variably FDG-avid or PET negative; regression on CT Spleen, Liver:> 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified"|2 years||||percentage of participants analyzed|||Number
2688035|NCT01336621|Primary|Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Urine Volume|The PVR bladder ultrasound was used to assess urinary retention. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Milliliter (mL)||Standard Deviation|Mean
2687981|NCT01336933|Primary|Complete Response Rate of Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) and Pralatrexate (P) Treatment|"Complete Response Rate (CR) was reported at the end of the CEOP-P (6 courses for patients not receiving transplant and 4-6 courses for patients receiving transplant). Response assessment was performed by computerized tomography (CT) or positron emission tomography (PET)/CT based on the investigator's preference after cycles 2, 4 and 6. Response was assessed by the treating physician according to the Cheson Revised response criteria (Cheson et al,, 2007) or International Harmonization Project criteria (Cheson, 2007), based on imaging modality used.~Complete Response Definition: Disappearance of all evidence of disease Nodal Masses: (a) [18F]fluorodeoxyglucose(FDG)-avid or PET positive prior to therapy; mass of any size permitted if PETnegative (b) Variably FDG-avid or PET negative; regression to normal size on CT Spleen, Liver: Not palpable, nodules disappeared Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative"|168 days - 252 days (4-6 courses; 42 days per course)||||percentage of participants analyzed|||Number
2687982|NCT01336894|Secondary|Pulmonary Function Test Values|Pulmonary function test values include forced expiratory volume 1 (FEV1), carbon monoxide diffusion (DLCO) and forced vital capacity (FVC).|Up to 12 months post-therapy|Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.||||||
2687983|NCT01336894|Secondary|Disease-free Survival|Disease free survival is defined as the time from randomization until documented disease recurrence or death, whichever occurs first. Patient who are disease free and alive at the time of analysis will be censored at the time of their last follow up.|Up to 5 years post-randomization|Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.||||||
2687984|NCT01336894|Secondary|Adverse Event Profiles at 12 Months Post-therapy|"Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0.~Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death."|12 months post-therapy|Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.||||||
2687985|NCT01336894|Secondary|Adverse Event Profiles at 3 Months Post-therapy|"Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0.~Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death."|3 months post-therapy|All enrolled participants who received protocol interventions and had adverse event reported at months 3 post-therapy.|||Participants|||Count of Participants
2687986|NCT01336894|Secondary|Adverse Event Profiles at 1 Month Post-therapy|"Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Toxicity Criteria (CTCAE), Version 4.0.~Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death."|1 month post-therapy|All enrolled participants who received protocol interventions and had adverse events reported at 1 month post-therapy.|||Participants|||Count of Participants
2687987|NCT01336894|Secondary|Loco-regional Recurrence-free Survival|Loco-regional recurrence is defined as recurrence within the same lobe or hilum (N1 nodes), or within 2 cm of the staple line or within 2 cm of the PTV after treatment effects such as scarring have subsided.|Up to 5 years post-randomization|Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.||||||
2687988|NCT01336894|Primary|3-year Overall Survival (OS) Rate|Overall survival is defined as the time from randomization until death from any cause.|Up to 3 years post-randomization|Study terminated prematurely. Planned analyses was not performed due to the nature of the closure endpoint data is not available.||||||
2687989|NCT01336803|Secondary|Differentiation of CD163-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas|Differentiation of CD163-positive tumor-associated macrophages (TAM) between lymphoma and bone sarcoma was assessed as the difference of mean area density of CD163-positive TAM in those populations.|24 hours||||Percentage area of CD163-positive TAM||Standard Deviation|Mean
2687990|NCT01336803|Secondary|Differentiation of CD68-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas|Differentiation of CD68-positive tumor-associated macrophages (TAM) between lymphoma and bone sarcoma was assessed as the difference of mean area density of CD68-positive TAM in those populations.|24 hours||||Percentage of CD68-positive TAM||Standard Deviation|Mean
2687991|NCT01336803|Secondary|Differentiation of Lymphoma and Bone Sarcomas With Ferumoxytol-enhanced MRI|"Differentiation of lymphoma from bone sarcoma was assessed as the difference of mean T2 * relaxation time determined by ferumoxytol-enhanced MRI.~."|24 hours|The analysis population for this outcome includes the participants with bone sarcoma who participated in the pilot study.|||milliseconds||Standard Deviation|Mean
2687992|NCT01336803|Secondary|Differentiation of Bone Sarcomas Pre-ferumoxytol and Post-ferumoxytol Contrast|Differentiation of bone sarcomas pre-ferumoxytol and post-ferumoxytol contrast was assessed by difference of mean T2 * relaxation time pre-ferumoxytol and post-ferumoxytol contrast, in bone sarcoma subjects only.|Baseline and Post-Treatment-24 hours|Only the participants with bone sarcomas were evaluated for this outcome.|||milliseconds||Standard Deviation|Mean
2687993|NCT01336803|Primary|T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects|Differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI) was assessed as the difference of mean T2 * relaxation time of bone sarcoma and osteomyelitis subjects. The outcome is reported as the difference of the mean T2 * values, with standard deviation.|24 hours|This initial phase of the study was a pilot assessment of participants with bone sarcomas compared to participants with osteomyelitis.|||milliseconds||Standard Deviation|Mean
2687994|NCT01336764|Primary|Reduced Heart Rate During Driving (Aggregated Over Sessions)|averaged over sessions|during 60-90 min driving intervention over the 3 intervention visits which were approximately one week apart||||beats per minute||Standard Deviation|Mean
2688076|NCT01336413|Secondary|Beck Depression Inventory-II (BDI-II)|21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Scores range from 0 (no depression) to 63 (severe depression).|Baseline, 4 Weeks, and 8 Weeks|3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.|||Total Score||Standard Error|Mean
2710800|NCT01167829|Secondary|Free T Maximum Concentration|Free T normal range 4.7-18 ng/dL|baseline & day 9|per protocol|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
2687995|NCT01336738|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Loss From Baseline|The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c. Participants with >= 1% or >= 2% body weight loss from baseline signifies an improvement of glycemia.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.|||percentage of participants|||Number
2687996|NCT01336738|Secondary|Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Gain From Baseline|Overweight or obesity increases the risk for developing diabetes. Participants with >= 1% or >= 2% body weight gain from baseline signifies a higher risk of diabetes.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.|||percentage of participants|||Number
2687997|NCT01336738|Secondary|Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12|Overweight or obesity increases the risk for developing diabetes. The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c.|Baseline, Week 1, 2, 4, 8, 12|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.|||kilogram (kg)||Standard Deviation|Mean
2687998|NCT01336738|Secondary|Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Week 12|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.|||percentage of participants|||Number
2687999|NCT01336738|Secondary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Baseline, Week 1, 2, 4, 8|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.|||percentage of hemoglobin||Standard Deviation|Mean
2688000|NCT01336738|Secondary|Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12||Baseline, Week 1, 2, 4, 8, 12|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.|||milligram/deciliter (mg/dL)||Standard Deviation|Mean
2688001|NCT01336738|Primary|Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12|HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.|Baseline, Week 12|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.|||percentage of hemoglobin||Standard Deviation|Mean
2688002|NCT01336712|Secondary|Cumulative Incidence of Chronic Graft-versus-host Disease||2 year||||percentage of patients analyzed|||Number
2688003|NCT01336712|Secondary|Relapse Rate||2 year||||percentage of patients analyzed|||Number
2688004|NCT01336712|Secondary|Non-relapsed Mortality (NRM) Percentage||2 year||||percentage of patients|||Number
2688005|NCT01336712|Secondary|Disease Free Survival (DFS) Percentage||2 year||||percentage of patients analyzed|||Number
2688006|NCT01336712|Secondary|Percentage of Participatns With Donor Chimerism Post-transplant|Characterize donor hematopoietic chimerism in peripheral blood at day 30 after HSCT.|Day 30||||percentage of patients|||Number
2688007|NCT01336712|Secondary|Survival|To obtain estimate of overall survival (OS)|2 year||||percentage of patients analyzed|||Number
2688008|NCT01336712|Primary|Percentage of Patients Experiencing Hemorrhagic Cystitis Post Transplant|1.1 To estimate the incidence of BK virus-associated hemorrhagic cystitis following a TBI-based myeloablative haploidentical HSCT in patients with high risk hematologic malignancies.|6 months||||percentage of patients|||Number
2688009|NCT01336647|Secondary|Safety and Tolerability of Ha44 Gel|The number of subjects with Treatment emergent AEs (TEAEs) related to the study medication will be reported by treatment group.|From treatment to last visit of the study at 14 days|All subjects who participated|||participants with treatment related AEs|||Number
2688010|NCT01336647|Primary|Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit||Follow up visit at days 1, 7 and 14 days|Intent to Treat|||participants|||Number
2688011|NCT01336634|Secondary|Volume of Distribution (V/F) of Dabrafenib and Trametinib|Blood samples from participants were collected for population pharmacokinetic analysis including V/F following oral dosing of dabrafenib and trametinib.|Week 3, Week 6, Week 12 and Week 18|PK Set|||Liter||95% Confidence Interval|Mean
2688012|NCT01336634|Secondary|Apparent Clearance (CL/F) of Dabrafenib and Trametinib|Blood samples from participants were collected for population pharmacokinetic analysis including CL/F following oral dosing of dabrafenib and trametinib.|Week 3, Week 6, Week 12 and Week 18|PK Set|||Liter/hour||95% Confidence Interval|Mean
2688034|NCT01336621|Primary|Number of Participants With Suicidal Ideation or Behavior Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score|Number of participants with suicidal ideation or behavior during treatment were assessed using the C-SSRS score scale. It is a brief questionnaire designed to assess severity and change in suicidality by integrating both behavior and ideation using a semi-structured interview to probe participant responses. Participants are classified with respect to extent of suicidal ideation, extent of suicidal behavior, and with respect to self-injurious behavior.|Up to 5.8 years|Safety Population|||Participants|||Number
2688013|NCT01336634|Secondary|Number of Participants With AEs and Serious AEs (SAEs)|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function.|Up to Week 12 and then every 3 weeks up to follow up, for an average of 13.8 months|All treated Population for Coh- A, Second line All Treated Population for Coh-B, and First-Line All Treated Population for Coh- C|||Participants|||Number
2688014|NCT01336634|Secondary|Number of Participants With Abnormal Hematology Values|Blood samples were collected from participants for evaluation of hematology parameters by worst case post-Baseline increase. The hematology parameters included leukocytes, neutrophils, platelets and high and low hemoglobin and lymphocytes. Participants were counted in the category that their values shows any grade increase , Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Up to Week 12 and then every 3 weeks until discharge, for an average of 13.8 months|All treated Population for Coh- A, Second line All Treated Population for Coh-B, and First-Line All Treated Population for Coh-C|||Participants|||Number
2688015|NCT01336634|Secondary|Number of Participants With Abnormal Clinical Chemistry Values|Blood samples were collected from participants for evaluation of clinical chemistry parameters by worst case post-Baseline increase. The clinical chemistry parameters included creatinine, phosphate and high and low calcium, glucose, magnesium, potassium and sodium. Participants were counted in the category that their values shows any grade increase , Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).|Up to Week 12 and then every 3 weeks until discharge, for an average of 13.8 months|All treated Population for Coh- A, Second line All Treated Population for Coh-B, and First-Line All Treated Population for Coh-C|||Participants|||Number
2688016|NCT01336634|Secondary|Number of Participants With Abnormal Echocardiogram Findings|Echocardiography scans were obtained at given time points using an echocardiogram and the findings for left ventricular ejection fraction (LVEF) were obtained. LVEF values at worst case post-Baseline were recorded as any increase and any decrease values.|Week 6, Week 15 and then every 9 weeks until discharge, for an average of 13.8 months|All treated Population for Coh- A, Second line All Treated Population for Coh-B, and First-Line All Treated Population for Coh- C|||Participants|||Number
2688017|NCT01336634|Secondary|Number of Participants With Abnormal Electrocardiogram (ECG) Values|Single measurements of 12-lead ECGs were obtained at given time points using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT (QTc) interval. ECG values at worst case post-Baseline were categorized as 'clinically significant change from Baseline' and 'not a clinically significant change'.|Week 3, Week 6, Week 15 and then every 9 weeks until discharge, for an average of 13.8 months|All treated Population for Coh- A, Second line All Treated Population for Coh-B, and First-Line All Treated Population for Coh- C|||Participants|||Number
2688018|NCT01336634|Secondary|Number of Participants With Abnormal Vital Signs Values|Number of participants with abnormal values of vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and temperature were evaluated. Participants with worst case post-Baseline vital sign values were presented at the given timepoints. Only those participants with data available at the specified data points were analyzed. All treated population was used for monotherapy cohort which comprised of all participants in the monotherapy cohort who receive at least one dose of study treatment. HR: <60 bpm clinical concern-low; >100 bpm Clinical concern-high Temperature: <=35 °C clinical concern - low; >=38 °C clinical concern - high For SBP change from baseline, the following categories will be used: Grade 0: <120 mm Hg; Grade 1: >=120-<140 mmHg; Grade 2: >=140-<160 mmHg; Grade 3: >=160 mmHg; For DBP change from baseline, the following categories will be used: Grade 0: <80 mm Hg; Grade 1: >=80-<90 mmHg; Grade 2: 90-<100 mmHg; Grade 3: >=100mmHg|Up to Week 12 and then every 3 weeks until discharge, for an average of 13.8 months|All treated Population for Coh- A, Second line All Treated Population for Coh-B, and First-Line All Treated Population for Coh- C|||Participants|||Number
2688019|NCT01336634|Secondary|Overall Survival (OS) at the Date of Analysis|OS defined as the time from first dose until death due to any cause. CI estimated using the Brookmeyer Crowley method. A value of NA indicates where no data is available or not able to determine the value. The upper bound of the 95 percent CI for the median was not reached due to insufficient event rates for Arm 2 (58 percent) and Arm 3 (28 percent).|At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months|Second-Line All Treated Population for Coh-A and Coh-B, and First-Line All Treated Population for Coh-C|||Months||95% Confidence Interval|Median
2688020|NCT01336634|Secondary|Progression Free Survival (PFS) at the Date of Analysis|PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause. The target and non-target lesions were identified at time of screening and the same lesions were re-assessed by a contrast-enhanced brain magnetic resonance imaging (MRI) or Computed tomography (CT) every 6 wks after initiation of study treatment until Week 36 and then every 12 wks. CI estimated using the Brookmeyer Crowley method. A value of NA indicates where no data is available or not able to determine the value for Arm 3 due to a low event rate in the population (36 percent).|At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months|Second-Line All Treated Population for Coh-A and Coh-B, and First-Line All Treated Population for Coh-C|||Months||95% Confidence Interval|Median
2688021|NCT01336634|Secondary|Duration of Response (DoR) at the Date of Analysis|DoR is defined for the subset of participants with confirmed CR or PR, as the time from first documented evidence of CR or PR until time of first documented disease progression or death due to any cause. The response was analyzed every 6 weeks after initiation of study treatment until Week 36 and then every 12 wks. Disease progression will be based on radiological assessments [magnetic resonance imaging (MRI) or computed tomography (CT)]. Confidence Intervals (CIs) estimated using the Brookmeyer Crowley method. Upper limit of confidence interval was not reached as data were not yet mature. A value of NA indicates where no data is available or not able to determine the value for Arm 3 due to a low event rate in that population (27 percent).|At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months|Second-Line All Treated Population for Coh-A and Coh-B, and First-Line All Treated Population for Coh-C|||Months||95% Confidence Interval|Median
2688022|NCT01336634|Primary|Percentage of Participants With Overall Response Rate (ORR) at the Date of Analysis|ORR is defined as the percentage of par. with a confirmed complete response (CR) or partial response (PR) by investigator assessment as per Response Evaluation Criteria In Solid Tumors evaluates the response on the basis of target and non-target lesions, and best over all response. The response rate was analyzed every 6 weeks (wks) after initiation of study treatment until Week 36 and then every 12 wks until discharge or crossover. Percentage of par. analyzed as number of par. having overall response on the date of analysis from Baseline multiply by 100. The Second Line Plus All Treated Population used for cohort A and B consisted of all par. in the All Treated Population who had received at least one line of prior anti-cancer therapy for advanced/metastatic disease. The First-Line All Treated Population used for cohort C consisted of all par. in the All Treated Population who had not received any prior anti-cancer therapy for advanced/metastatic disease.|At Week 6 then every 6 weeks up to Week 36.and then every 12 weeks until discharge, for an average of 13.8 months|Second-Line All Treated Population for Coh-A and Coh-B, and First-Line All Treated Population for Coh-C|||Percentage of Participants||95% Confidence Interval|Number
2688023|NCT01336621|Secondary|Number of Participants Who Remained Seizure-free|The seizure frequency was recorded in daily seizure calendar by participants during the treatment period. Number of participants who were treated retigabine for at least 6 months and who remained seizure free for any 6 continuous months as well as number of participants who were treated with retigabine for at least 12 months and who remained seizure free for any 12 continuous months are presented.|Up to 5.8 years|Safety population|||Participants|||Number
2688024|NCT01336621|Secondary|Number of Participants Experiencing an Increase in 28-day Partial-onset Seizure Frequency From Baseline|The seizure frequency was recorded in daily seizure calendar by participants during the treatment period. Baseline assessments in this OLE study are defined by and taken directly from the Baseline assessments in the parent study NCT01336621.|Baseline and up to 5.8 years|Safety Population|||Participants|||Number
2688025|NCT01336621|Secondary|Percent Change From Baseline in 28-day Partial-onset Seizure Frequency|The seizure frequency was recorded in daily seizure calendar by participants during the treatment period. Percent change from Baseline in 28-day partial onset seizure frequency was presented as mean and standard deviation (SD). Baseline assessments in this OLE study are defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Percent change from Baseline was calculated as post-Baseline value minus Baseline value divided by Baseline value into 100.|Baseline and up to 5.8 years|Safety Population|||Percent change||Standard Deviation|Mean
2688026|NCT01336621|Secondary|Number of Participants Experiencing a 0 to <25, 25 to <50, 50 to <75 and 75 to 100 Percent Reduction in 28 Day POS Frequency From Baseline|The seizure frequency was recorded in daily seizure calendar by participants during the treatment period. Baseline assessments in this OLE study are defined by and taken directly from the Baseline assessments in the parent study NCT01336621.|Baseline and up to 5.8 years|Safety Population|||Participants|||Number
2688027|NCT01336621|Primary|Time From Discontinuation of Retigabine to Resolution of All Dermatologist-confirmed Abnormal Discoloration|Assessments were at approximately 6-monthly intervals (timed relative to the participants previous dermatology assessment) until the abnormal discoloration either resolved or stabilized (as defined by no changes over 2 consecutive 6-monthly assessments performed by the dermatologist over at least 12 months after discontinuation of retigabine). The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. Only participants with resolution of the specified tissue are included in this analysis.|Up to 2.6 years|All SFUCP Subjects|||Days||Full Range|Median
2688028|NCT01336621|Primary|Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation|Retinal pigmentary abnormality was determined by either an ophthalmologist or retina specialist. Retinal pigmentary abnormality included abnormality of macula, peripheral retina and unspecified location. If a participant had pigmentary abnormality of macula and pigmentary abnormality of the peripheral retina both should be resolved in order for retinal pigmentary abnormality to be considered resolved. If a participant had non-retinal ocular pigmentary abnormality in more than one location (conjunctiva, sclera, cornea, iris or lens), all should be resolved for non-retinal pigmentary abnormality to be considered resolved.|Up to 2.6 years|All SFUCP Subjects|||Days||Full Range|Median
2688029|NCT01336621|Primary|Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine|Participants who enter the SFUCP who had an on-treatment finding(s) of abnormal discoloration of skin, lips, nails or mucosa confirmed by a dermatologist entered the SFUCP and underwent assessments performed by a dermatologist at 6-monthly intervals. The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa.|Up to 2.6 years|All SFUCP Subjects|||Participants|||Number
2688030|NCT01336621|Primary|Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine|The ophthalmologist/retina specialist determined the presence or absence of retinal and non-retinal ocular abnormalities. Retinal abnormalities included abnormalities in the macula and/or the peripheral retina and non-retinal ocular pigmentary abnormality.|Up to 2.6 years|All SFUCP Subjects|||Participants|||Number
2688031|NCT01336621|Primary|Duration of Retigabine Exposure|Duration of exposure was calculated from the first dose through the last dose during study including the Taper Phase and presented using median and full range.|Up to 5.8 years|Safety Population|||Weeks||Full Range|Median
2688032|NCT01336621|Primary|Number of Participants Experiencing Worsening of Seizures|Worsening of seizures was defined as an increase in seizure frequency or the occurrence of a new, more severe seizure type, or status epilepticus occurring in a participant without a history of status epilepticus. An increase in seizure frequency was defined as doubling of the 28-day seizure frequency compared to the 28-day Baseline seizure frequency established in the parent study. Number of participants experiencing worsening of seizure during study period are presented.|Up to 5.8 years|Safety Population|||Participants|||Number
2688033|NCT01336621|Primary|Number of Participants Experiencing New Seizure Types|Number of participants experiencing new seizure type that is seizure not experienced before were summarized. New seizure types were classified into 5 classes including type A (simple partial seizure), type B (complex partial seizure), type C (Partials, evolving to Secondary Generalized Seizures), type D (Generalized, excluding Myoclonic Seizures), type D2 (Myoclonic Seizures) and type E (Unclassified Seizures).|Up to 5.8 years|Safety Population|||Participants|||Number
2688036|NCT01336621|Primary|Changes From Baseline in American Urological Association Symptom Scale (AUA SS) Score|The effect of retigabine on bladder function was assessed using AUA symptom index. It is a 7-item Likert-scored scale ranging from 0 (no symptom at all) to 5 (almost always symptoms present) with a total possible score of 35. AUA SS score is the sum of the responses to these seven questions. The total score for all questions was classified as mild (0 to 7), moderate (8 to 19), or severe (>19). Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Score on AUA SS scale||Standard Deviation|Mean
2688037|NCT01336621|Primary|Change From Baseline in Urine Creatinine Levels|Urine samples were collected from participants for evaluation of change from Baseline in urinalysis parameters including creatinine levels. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||µmol/L||Standard Deviation|Mean
2688038|NCT01336621|Primary|Change From Baseline in Urine Albumin Levels|Urine samples were collected from participants for evaluation of change from Baseline in urinalysis parameters including albumin levels. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Milligrams per liter (mg/L)||Standard Deviation|Mean
2688039|NCT01336621|Primary|Change From Baseline in Urine Albumin Creatinine Ratio|Urine samples were collected from participants for evaluation of change from Baseline in urinalysis parameters including albumin creatinine ratio. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Mg of urine albumin/ mmol of creatinine||Standard Deviation|Mean
2688040|NCT01336621|Primary|Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels|Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including percent basophils, eosinophils, lymphocytes, monocytes, neutrophils and RDW. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Percent of blood components||Standard Deviation|Mean
2688041|NCT01336621|Primary|Change From Baseline in RBC Count|Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including RBC count. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Up to 5.8 years|Safety Population|||Tetra cells per liter (TI/L)||Standard Deviation|Mean
2688042|NCT01336621|Primary|Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels|Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including MCV and MPV. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Femtoliter (fL)||Standard Deviation|Mean
2688043|NCT01336621|Primary|Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels|Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including MCH. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Picograms (Pg)||Standard Deviation|Mean
2688044|NCT01336621|Primary|Change From Baseline in Hematocrit Levels|Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including hematocrit. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Proportion of red blood cells in blood||Standard Deviation|Mean
2688045|NCT01336621|Primary|Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels|Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including hemoglobin and MCHC. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||G/L||Standard Deviation|Mean
2688046|NCT01336621|Primary|Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count|Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including absolute basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count and WBC count. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Giga cells per liter (GI/L)||Standard Deviation|Mean
2688047|NCT01336621|Primary|Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN|Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including calcium, chloride, CO2, glucose, potassium, magnesium, sodium and BUN. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2688048|NCT01336621|Primary|Change From Baseline in BUN/Creatinine Ratio|Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including BUN/creatinine ratio. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Ratio of BUN to creatinine||Standard Deviation|Mean
2688049|NCT01336621|Primary|Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine|Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including direct bilirubin, total bilirubin and creatinine. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Micromole per liter (µmol/L)||Standard Deviation|Mean
2688050|NCT01336621|Primary|Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels|Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including alk. phosphatase, ALT, AST, creatine kinase and LD. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||International unit per liter (IU/L)||Standard Deviation|Mean
2688051|NCT01336621|Primary|Change From Baseline in Albumin and Total Protein|Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including albumin and total protein. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Gram per liter (G/L)||Standard Deviation|Mean
2688052|NCT01336621|Primary|Number of Participants With Urinalysis Parameters of PCC|Urine samples were collected from participants at specific time points. Number of participants with urinalysis parameters of PCC at 'any visit post-Baseline' are presented. Urinalysis parameters for which PCC values were identified were albumin/creatinine ratio (if value is >11.3), red blood cells (RBC) (if value is 3-5 or higher), WBC (if value is 5-10 or higher for male and 10-15 or higher for females), specific gravity (if value is <1.001 or >1.035) and potential of hydrogen (pH) (if value is <4.6 or >8.0). Only those participants with data available at specific time points were analyzed (represented by n=X in the category titles).|Up to 5.8 years|Safety Population|||Participants|||Number
2688053|NCT01336621|Primary|Number of Participants With Hematology Parameters of PCC|Blood samples were collected from participants to evaluate hematology parameters. Number of participants with clinical hematology parameters of PCC at 'any visit post-Baseline' are presented. Hematology parameters for which PCC values were identified were eosinophils (if value is >0.8), hematocrit (if value is <=0.32 for males and <=0.28 for females), platelet count (if value is <=100 or >=550), total neutrophils (if value is <=1.8), white blood cells (WBC) (if value is <=2.8 or >=16). Only those participants with data available at specific time points were analyzed (represented by n=X in the category titles).|Up to 5.8 years|Safety Population|||Participants|||Number
2688054|NCT01336621|Primary|Number of Participants With Clinical Chemistry Parameters of PCC|Number of participants with chemistry parameters of PCC at 'any visit post-Baseline' are presented. Chemistry parameters for which PCC values were identified were alanine aminotransferase (ALT) (if value >=3 * upper limit of normal [ULN]), alkaline phosphatase (alk.phosphatase) (if value >=3*ULN), aspartate aminotransferase (AST) (if value >=3*ULN), calcium (if value <=1.8962 or >=2.8692), carbon-di-oxide (CO2) (if value <=18 or >=36), chloride (if value <=92 or >=112), creatine kinase (if value >=3*ULN), direct bilirubin (if value >=1.5*ULN), glucose (if value <=2.7755 or >=11.102), lactate dehydrogenase (LD) (if value >=3*ULN), magnesium (if value <0.36 or >2.50), potassium (if value <=3.0 or >=6.0), sodium (if value <=127 or >=153), total bilirubin (if value >=1.5*ULN), total protein (if value <45 or >100), blood urea nitrogen (BUN) (if value >=14.28). Only those participants with data available at specific time points were analyzed (represented by n=X in the category titles).|Up to 5.8 years|Safety Population|||Participants|||Number
2688055|NCT01336621|Primary|Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval|Single measurements of 12-lead ECG were obtained in supine position after at least 10 minutes of rest using an ECG machine to measure parameters including PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF and RR interval. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Milliseconds (msec)||Standard Deviation|Mean
2688056|NCT01336621|Primary|Change From Baseline in Electrocardiogram (ECG) Parameter Including HR|Single measurements of 12-lead ECG were obtained in supine position after at least 10 minutes of rest using an ECG machine to measure HR. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).|Baseline and up to 5.8 years|Safety Population|||Beats per minute (bpm)||Standard Deviation|Mean
2688057|NCT01336621|Primary|Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight|Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured after at least 5 minutes of rest. Body weight was measured without shoes and wearing light clothing. Baseline assessments in this OLE study were defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Increase or decrease of >=20 in SBP, increase or decrease of >=15 in DBP and HR were considered as PCC values. Number of participants with PCC values of vital signs for any visit post-Baseline are presented.|Up to 5.8 years|Safety Population|||Participants|||Number
2688058|NCT01336621|Primary|Number of Participants With Decrease in Confrontational Visual Field From Initial Examination|Number of participants with a clinically significant decrease in confrontational visual field from initial examination were evaluated. Only abnormalities occurring on-treatment with retigabine were presented.|Up to 5.8 years|Safety Population. Only those subjects with both initial and at least 1 follow-up exam while on RTG treatment are presented.|||Participants|||Number
2688059|NCT01336621|Primary|Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination|Number of participants with a clinically significant decrease in visual acuity from initial examination were evaluated. Only abnormalities occurring on-treatment with retigabine were presented.|Up to 5.8 years|Safety Population. Only those participants with both initial and at least 1 follow-up exam while on RTG treatment are presented.|||Participants|||Number
2688060|NCT01336621|Primary|Number of Participants With Abnormal Discoloration of Skin|Number of participants with Dermatologist-Confirmed abnormal discoloration of skin including skin around the eyes and eyelids, lips, nails, or mucosa were evaluated. Only abnormalities occurring on-treatment with retigabine were presented.|Up to 5.8 years|Safety Population. Only those participants who had at least one skin exam by the investigator or dermatologist on or before the last dose of RTG or dermatologist-confirmed discoloration with start date on or before the date of last dose of RTG are presented.|||Participants|||Number
2688061|NCT01336621|Primary|Number of Participants With Pigmentation of Non-retinal Ocular Tissue(s)|Number of participants with abnormal findings after eye examination were evaluated. Pigmentation of non-retinal ocular tissue (s) detected on-treatment with retigabine were presented. Non-retinal pigmentary abnormalities included abnormalities in the sclera and/ or conjunctiva, cornea, iris and lens.|Up to 5.8 years|Safety Population. Only those participants with >=1 ophthalmology exam on or before last dose of RTG are presented.|||Participants|||Number
2688062|NCT01336621|Primary|Number of Participants With Retinal Pigmentary Abnormalities|Number of participants with abnormal findings after eye examination were evaluated. Only retinal pigmentary abnormalities detected on-treatment with retigabine were presented. Retinal pigmentary abnormalities included abnormalities in the macula, peripheral retina and unspecified location.|Up to 5.8 years|Safety Population. Only those participants with >=1 ophthalmology exam on or before last dose of RTG are presented.|||Participants|||Number
2688063|NCT01336621|Primary|Number of Participants Withdrawn Due to TEAEs|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolonged existing hospitalization, results in disability, is a congenital anomaly/birth defect or is associated with liver injury or impaired liver function. TEAE refers to an AE for which the onset was on or after the date of the first retigabine dose and on or before 30 days after the last retigabine dose date.|Up to 5.8 years|Safety Population|||Participants|||Number
2688064|NCT01336621|Primary|Number of Participants With AEs and SAEs: All SFUCP Subjects|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect or is associated with liver injury or impaired liver function. The following AEs were collected in the SFUCP: AEs related to the finding(s) of pigmentation/, discoloration of the eye/skin, AEs related to unexplained vision loss, SAEs, Deaths and Pregnancies. SFUCP collected AEs are those for which onset was 31 days or more after the last dose of retigabine. The analysis was performed on the All SFUCP Subjects population which comprised of all subjects who enter the SFUCP.|Up to 2.6 years|All SFUCP subjects|||Participants|||Number
2688065|NCT01336621|Primary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (TESAEs): Safety Population|An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect or is associated with liver injury or impaired liver function. TEAE refers to an AE for which the onset was on or after the date of the first retigabine dose in this study and on or before 30 days after the last retigabine dose date. AEs that started in the parent study that increased in severity during this study were also considered treatment-emergent. The analysis was performed on Safety Population, which included participants who took at least one dose of study medication after they had enrolled into this OLE study.|Up to 5.8 years|Safety Population|||Participants|||Number
2688077|NCT01336413|Primary|Tower of London (Subscale Test of BAC) - PRIMARY COGNITIVE OUTCOME MEASURE|Subscale test asking subjects to determine the minimum number of moves that will be required to make convert one image of colored balls on pegs into a second different image. The test administers 20 items/images, with 2 additional items if all of the first 20 are answered correctly. Thus, scores range from 0-22, with lower scores representing greater impairment. Raw scores are converted to z scores that generally range from -3 to 3, with lower scores again representing greater impairment.|Baseline, 4 Weeks, and 8 Weeks|3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.|||z Score||Standard Error|Mean
2688127|NCT01335932|Secondary|Use of Granulocyte-colony Stimulating Factor|Number of participants requiring Granulocyte-colony stimulating factor|by 35 days post-randomization||||Participants|||Count of Participants
2688128|NCT01335932|Secondary|Time to Neutropenia|Time to neutropenia by 35 days post-randomization|by 35 days post-randomization||||days|||Number
2688066|NCT01336608|Secondary|Mean Number of Occasions Rescue Medication [Albuterol (Salbutamol)] Used During a 24-hour Period Averaged Over the Entire 24-week Treatment Period|Participants were given daily record cards for daily completion from BL (Week -1) through Week 24 (Visit 6) each morning and prior to taking study medication (i.e., single-blind and double-blind study medication) supplemental medication (albuterol [salbutamol] if received) and ipratropium bromide (if received). Participants recorded number of occasions supplemental albuterol/salbutamol (MDI and/or nebules) used over the previous 24 hours and any medical problems that they had experienced and any medication used to treat these medical problems over the previous 24 hours. Analysis was performed using an analysis of covarience (ANCOVA) model with covariates of treatment, BL mean of occasions of rescue medication use (Week -1), history of exacerbation, and geographical region.|BL (Week -1), Week 1 to Week 24|ITT Population: all randomized participants who received at least one dose of study medication. Only those participants with at least 1 on treatment rescue medication measurement during the treatment period and without missing covariate information were analyzed.|||Occasions per 24 hours||Standard Error|Least Squares Mean
2688067|NCT01336608|Secondary|Change From BL in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 168|Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry at Screening, Days 1, 28, 84, 126, and 168. BL FEV1 was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 was defined as the mean of the FEV1 values obtained 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was preformed using a repeated measures model with covariates of visit, treatment, history of exacerbation strata, geographical region, BL FEV1 and interaction terms of BL by visit and treatment by visit.|BL to Day 168|ITT Population. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||Liters (L)||Standard Error|Least Squares Mean
2688068|NCT01336608|Primary|Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 24-week Treatment Period (Day 168)|PWV is defined as the speed of travel of the pressure pulse along an arterial segment and can be obtained for any arterial segment accessible to palpation. aPWV is measured with tonometers positioned transcutaneously at the base of the common carotid artery and over the femoral artery. PWV increases with arterial stiffness and is defined by the Moens-Korteweg equation: PWV=square root of (Eh/2ρR), where E is Young's modulus of the arterial wall, h is the wall thickness, R is the arterial radius at the end of diastole, and ρ is the blood density. Change from BL was calculated as the Day 168 value minus the BL value. The analysis was performed using a repeated measures model with covariates of treatment, visit, age, gender, smoking history, history of exacerbation strata, geographical region, BL aPWV and interaction terms of BL by visit and treatment by visit.|BL to Day 168|ITT Population: all randomized par. who received at least one dose of study medication. Number of par. presented represent those with data available at the time point being presented; however, all par. in the ITT population without missing covariate information and with at least one post BL measurement are included in the analysis.|||meters per second (m/sec)||Standard Error|Least Squares Mean
2688069|NCT01336569|Primary|Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy)|As measured by Goldmann applanation tonometry. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.|Baseline, up to 6 weeks|Intent-to-Treat (ITT): All participants who received study medication and had at least one on-therapy study visit.|||millimeters mercury (mmHg)||Standard Deviation|Mean
2688070|NCT01336413|Other Pre-specified|Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (Exploratory Neuroimaging Outcome)|Quantitative Susceptibility Mapping/Susceptibility Tensor Imaging (QSM/STI) to assess possible myelin brain changes related to the intervention.|10 weeks||||magnetic susceptibility ratio||Standard Error|Mean
2688071|NCT01336413|Other Pre-specified|Diffusion Tensor Imaging (Exploratory Neuroimaging Outcome)|Diffusion Tensor Imaging (DTI) to assess possible white matter brain changes associated with intervention.|10 weeks||||fractional anisotropy index units||Standard Error|Mean
2688072|NCT01336413|Other Pre-specified|Functional Magnetic Resonance Imaging (Exploratory Neuroimaging Outcome)|Functional Magnetic Resonance Imaging (fMRI) to assess possible functional brain changes related to attention and emotion circuits associated with the intervention. The dependent measure is the BOLD (fMRI) response to images of faces expressing neutral emotions and fearful emotions.|10 weeks||||BOLD percent signal change in vmPFC||Standard Error|Mean
2688073|NCT01336413|Secondary|Connor-Davidson Resilience Scale (CD-RISC)|The CD-RISC was developed and tested as (i) a measure of degree of resilience, (ii) as a predictor of outcome to treatment with medication or psychotherapy, stress management and resilience-building, (iii) as a marker of progress during treatment, and (iv) as a marker of biological changes in the brain. The scale comprises 25 items, each rated on a 5-point scale (0-4) for a total range of 0-100, with higher scores reflecting greater resilience.|Baseline, 4 Weeks, and 8 Weeks|3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.|||Total Score||Standard Error|Mean
2688074|NCT01336413|Secondary|CAPS Total Scores|Mean scores in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while and increase in CAPS score indicates an increase (worsening) in PTSD symptoms.|Baseline, 4 Weeks, and 8 Weeks|3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.|||Total Score||Standard Error|Mean
2688075|NCT01336413|Secondary|BAC Composite|Composite z scores (allowing comparison from week 2 to week 10) to assess cognitive changes. The BAC includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. z scores are calculated from composite scores. Higher z scores are indicative of better cognitive performance, lower z scores are indicative of lower cognitive performance. Range of z scores anticipated to be between -3 and 3.|Baseline, 4 Weeks, and 8 Weeks|3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study.|||Composite z Score||Standard Error|Mean
2710801|NCT01167829|Secondary|Mean Estradiol Concentration||baseline & day 9|per protocol|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
2688078|NCT01336413|Primary|CAPS (Cluster D Symptoms) - PRIMARY BEHAVIORAL OUTCOME MEASURE|"The CAPS-IV criterion D is defined by persistent symptoms of increasing arousal (not present before the trauma), indicated by at least two of the following: difficulty falling or staying asleep, irritability or outbursts of anger, difficulty concentrating, hyper-vigilance, and exaggerated startle response There are two scales, frequency and intensity. Frequency scores range from 0 = none of the time to 4 = most or all of the time and intensity scores range from 0 = none to 4 = extreme. Severity scores are calculated from the sum of frequency and intensity scores. Five items are included in criterion D, thus the range of severity scores is 0-45. Higher scores are indicative of more symptoms."|Baseline, 4 Weeks, and 8 Weeks|3 subjects in Arm 1, and 1 subject in Arm 2, withdrew prior to the final visit of the study|||Score||Standard Error|Mean
2688079|NCT01336296|Secondary|Number of Patients Requiring Anti-lymphocyte Therapy for Acute Rejection||1 year||||participants|||Number
2688080|NCT01336296|Secondary|Incidence of Chronic Alloantibody Rejection or Chronic Allograft Arteriopathy by Banff '97|The Banff features suggestive of chronic rejection were: a) chronic transplant glomerulopathy: Glomerular basement membrane duplication and mesangial cell proliferation, and b) vasculopathy: Fibrous intimal thickening often with fragmentation of internal elastic lamina. Chronic changes in the interstitium (ci), tubules (ct), vessels (cv), and glomerulus (cg) were likewise graded into 0, 1, 2, and 3. The severity of interstitial fibrosis and tubular atrophy, as also chronic transplant glomerulopathy and vasculopathy were used to grade chronic allograft changes.|1 year||||participants|||Number
2688081|NCT01336296|Secondary|Difference in Renal Function|"Difference in renal function between groups at listed time points assessed by mean serum creatinine. Increased serum creatinine could indicate worsening renal function. A normal serum creatinine range for the transplant population varies by patient, but a typical range for Scr would be 1-2 mg/dL."|Difference at 1 month, 3 months, 6 months, 1 year||||mg/L||Standard Deviation|Mean
2688082|NCT01336296|Secondary|Severity of Acute Rejection by Banff '97 Criteria|"Severity of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) at 1 year. The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:~As with humoral rejection, there are both acute & chronic forms:~The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:~Class IA: there is at least 25% of parenchymal showing interstitial infiltration and foci of moderate tubulitis (defined as a certain number of immune cells present in tubular cross-sections).~Class IB: just like Class IA except there is more severe tubulitis.~Class IIA: there is mild-to-moderate intimal arteritis.~Class IIB: there is severe intimal arteritis comprising at least 25% of the lumenal area.~Class III: there is transmural (e.g. the full vessel wall thickness) arteritis."|Severity 1 year post transplant||||participants|||Number
2688083|NCT01336296|Primary|Incidence of Biopsy-confirmed Acute Rejection by Banff '97 Criteria (Updated 2007) 3, 6 and 12 Months Post Transplant|"Incidence of biopsy-confirmed acute rejection by Banff '97 Criteria (updated 2007) post transplant. The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:~As with humoral rejection, there are both acute & chronic forms:~The acute form of T-cell mediated rejection is furthermore subclassified as follows. Since this is the most common form of rejection, it is useful to know:~Class IA: there is at least 25% of parenchymal showing interstitial infiltration and foci of moderate tubulitis (defined as a certain number of immune cells present in tubular cross-sections).~Class IB: just like Class IA except there is more severe tubulitis.~Class IIA: there is mild-to-moderate intimal arteritis.~Class IIB: there is severe intimal arteritis comprising at least 25% of the lumenal area.~Class III: there is transmural (e.g. the full vessel wall thickness) arteritis."|3, 6 and 12 months post transplant||||participants|||Number
2688084|NCT01336205|Primary|Incidence of Patients Experiencing Severe Adverse Events (SAEs)|The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period|The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.|||Participants|||Number
2688085|NCT01336205|Primary|Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)|The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period|The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.|||Participants|||Number
2688086|NCT01336205|Primary|Incidence of Patients Experiencing at Least One Adverse Event (AE)|The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.|Baseline (Week 0) to end of the follow-up period|The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.|||Participants|||Number
2688087|NCT01336140|Secondary|Patients With Recorded Aminophylline Related Major Adverse Events|Aminophylline related adverse effects include: systemic hypotension (systolic blood pressure < 90 mmHg), any thachyarrhythmia (ventricular or supraventricular) and seizure.|Within 24 hours from the intervention.|All patients.|||participant|||Number
2688088|NCT01336140|Secondary|Global Symptom Score (GSS) of Regadenoson Related Adverse-effects|"GSS is the sum of severity-weighted (0 = none, 1 = mild, 2 = moderate, 3 = severe) regadenosnon-related adverse-effects of flushing, feeling hot, chest pain, chest discomfort, angina, headache, dizziness, abdominal cramps or discomfort, diarrhea, nausea.~GSS is calculated by weighting each side effect from 0 - 3 (as above) then add the severity weighted scores of all adverse effects (total of 10 as above).~The number of adverse effects contributing to the score is 10, each has a potential severity weight of 0 (absent) to 3 (severe). Thus:~Minimum possible Global Symptom Score (GSS) = 0 Maximum possible Global Symptom Score (GSS) = 30"|Within 2 hours from the intervention.|All patients.|||Global Symptom Score||Standard Deviation|Mean
2688089|NCT01336140|Secondary|Number of Patients With Any (One or More) Regadenoson-related Adverse-effect|"Regadenoson-related adverse-effects include: flushing, feeling hot, chest pain, chest discomfort, angina, headache, dizziness, abdominal cramps or discomfort, diarrhea, nausea.~When multiple adverse effects are reported, only one event is counted."|Within 2 hours from the intervention.|All patients.|||Participants|||Number
2688090|NCT01336140|Primary|Diarrhea (as Reported by the Patient)|"Number of patients who report any incident of diarrhea. Patients will be surveyed for incidents of diarrhea following to the completion of the cardiac stress testing procedure and prior to discharge from the laboratory (typically within 2 hours from stress completion).~The primary endpoint encompasses the number of patients with reported symptoms of diarrhea, not the number of bowel movements."|Within 2 hours from the intervention|All patients.|||participants|||Number
2688091|NCT01336023|Secondary|Mean Actual Daily Insulin Dose|Mean of the actual doses recorded at visit 28 (Week 26).|Week 26|The FAS included all randomised subjects. Missing data was imputed using LOCF. For 22 subjects, the dose values were missing hence did not contribute to the analysis. The comparison was made between the insulin products IDeg and IDeglira.|||units||Standard Deviation|Mean
2688092|NCT01336023|Secondary|Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test|Values of mean change in normalised iAUC0-4h values based on LOCF data derived from the glucose concentration profiles during a meal test. The meal test was performed at selected sites at baseline and after 26 weeks of treatment in the main trial period. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L using the available valid glucose observations and the associated actual elapsed time point.|Week 0, Week 26|The number of subjects analysed were equal to study population in which the meal test was perfomed at selected sites. Missing data was imputed using LOCF.|||mmol/L||Standard Deviation|Mean
2688093|NCT01336023|Secondary|Number of Hypoglycaemic Episodes|Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure.|Weeks 0-26|The Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparators. The missing data was imputed using LOCF. The number of subjects analysed in SAS for each arm are 412, 825 and 412, respectively.|||Events per 100 patient years of exposure|||Number
2688094|NCT01336023|Secondary|Mean Change From Baseline in Body Weight at Week 26|Values of mean change in body weight.|Week 0, Week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. Three subjects did not have their case book signed off due to discontinuation of an investigator’s participation in the trial; hence 1 subject from each arm was excluded from the FAS.|||kg||Standard Deviation|Mean
2688095|NCT01336023|Primary|Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.|Values of mean change in HbA1c.|Week 0, week 26|The FAS included all randomised subjects and missing data was imputed using LOCF. Three subjects did not have their case book signed off due to discontinuation of an investigator’s participation in the trial; hence 1 subject from each arm was excluded from the FAS.|||Percentage of glycosylated haemoglobin||Standard Deviation|Mean
2688096|NCT01335997|Secondary|Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) Blood Levels|Due to study termination caused by the decision to stop the development of the combination tablet, sufficient data were not available to perform the planned efficacy analysis, which is based on the cross-over data collected in period II and III.|Baseline and Week 12 and Week 20|Completers Population - participants that completed the study, have respective endpoint data available at baseline, end of period II and end of period III and were not off study drug more than 3 days prior to their period II and period III observations.||||||
2688097|NCT01335997|Primary|Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Blood Levels|Due to study termination caused by the decision to stop the development of the combination tablet, sufficient data were not available to perform the planned efficacy analysis, which is based on the cross-over data collected in period II and III.|Baseline and Week 12 and Week 20|Completers Population - participants that completed the study, have respective endpoint data available at baseline, end of period II and end of period III and were not off study drug more than 3 days prior to their period II and period III observations.||||||
2688098|NCT01335971|Secondary|Fold-change in Plasma Inflammatory Marker Concentrations (Follow-up to Baseline)|Inflammatory markers were measured in plasma at baseline and 4 weeks. Thiobarbituric acid reactive substances were measured in nmol malondialdehyde (MDA)/mL.|Baseline and 4 weeks|Number of participants analyzed is based on number of participants that had plasma samples available. Samples were missing for one participant in the 25 micromole group.|||fold change||Inter-Quartile Range|Median
2688099|NCT01335971|Secondary|Fold-change in Inflammatory Marker Concentrations in Bronchial Alveolar Lavage (Follow-up to Baseline) by Treatment Group|Inflammatory markers were measured in bronchial alveolar lavage samples at baseline and 4 weeks in the participants of this trial who had bronchoalveolar lavage samples obtained.Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage.|Baseline and 4 weeks|Number of participants analyzed is based on number of participants that had bronchial alveolar lavage samples available. Samples were missing for two participants in the placebo group.|||fold change||Inter-Quartile Range|Median
2688100|NCT01335971|Secondary|Fold-change in Serum Inflammatory Marker Concentrations (Follow-up to Baseline)|Inflammatory markers were measured in serum samples derived from venipuncture at baseline and 4 weeks in the serum of the participants of the trial.|Baseline and 4 weeks|Number of participants analyzed is based on number of participants that had plasma samples available. Samples were missing for one participant in the 25 micromole group.|||fold change||Inter-Quartile Range|Median
2688101|NCT01335971|Secondary|Fold-change in Isoprostane Concentrations (Follow-up to Baseline)|Isoprostane, an oxidant stress indicator, was measured in expired breath condensate at baseline and 4 weeks.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with expired breath condensate samples in which testing could be successfully performed. Samples were missing for two participants in the 25 micromole group and one participant in the 150 micromole group.|||fold change||Inter-Quartile Range|Median
2688120|NCT01335932|Secondary|Overall Mortality|Overall mortality amongst subjects who survive at least 7 days after randomization|at 7 days post-randomization||||events|||Number
2710802|NCT01167829|Secondary|Maximum Estradiol Concentration||baseline & day 9|per protocol|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
2688102|NCT01335971|Primary|Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C3 at 4 Weeks|The sixth primary design variable is the change from baseline in expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for two participants in the placebo group, one participant in the 25 micromole group, and one participant in the 150 micromole group.|||fold change||Inter-Quartile Range|Median
2688103|NCT01335971|Primary|Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C1 at 4 Weeks|The fifth primary design variable is the change from baseline in expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with alveolar macrophage samples in which assays could be successfully performed. Assays failed for two participants in the placebo group and two in the 150 micromole group.|||fold change||Inter-Quartile Range|Median
2688104|NCT01335971|Primary|Change From Baseline in Bronchial Epithelial Cell Expression of HO1 at 4 Weeks|The fourth primary design variable is the change from baseline in expression of Heme Oxygenase 1 (HO1) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for one participant in the placebo group.|||fold change||Inter-Quartile Range|Median
2688105|NCT01335971|Primary|Change From Baseline in Bronchial Epithelial Cell Expression of NQ01 and Keap1 at 4 Weeks|The third primary design variable is the change from baseline in NAD(P)H Quinone Dehydrogenase 1 (NQ01) and Kelch Like ECH Associated Protein 1 (Keap1) expression in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for two participants in the placebo group and one in the 150 micromole group.|||fold change||Inter-Quartile Range|Median
2688106|NCT01335971|Primary|Change From Baseline in Bronchial Epithelial Cell Expression of Nrf2 at 4 Weeks|The second primary design variable is the change from baseline in nuclear factor erythroid 2 like 2 (Nrf2) expression in bronchial epithelial cells (BEC) at 4 weeks by analysing Nrf2 protein. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for one participant in the placebo group and one in the 25 micromole group..|||fold change||Inter-Quartile Range|Median
2688107|NCT01335971|Primary|Change From Baseline in Alveolar Macrophage Expression of Nrf2 and Associated Genes at 4 Weeks|The first primary design variable is the change from baseline in nuclear factor erythroid 2 like 2 (Nrf2) expression in alveolar macrophages (AM) at 4 weeks by analysing Nrf2 protein and expression of a panel of Nrf2 regulated genes.Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data.|Baseline and 4 weeks|Number of participants analyzed based on number of individuals with alveolar macrophage samples in which assays could be successfully performed. Assays failed for two participants in the placebo group, one in the 25 micromole group, and one in the 150 micromole group.|||fold change||Inter-Quartile Range|Median
2688108|NCT01335932|Secondary|Number of Hospital-free Days Among Subjects by Day 28|Number of hospital-free days among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization|28 days||||days||Standard Deviation|Mean
2688109|NCT01335932|Secondary|Number of ICU-free Days Amongst Subjects by Day 28|Number of ICU-free days amongst subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization|28 days||||days||Standard Deviation|Mean
2688110|NCT01335932|Secondary|Number of Days in ICU Amongst Subjects by Day 28|Number of days in ICU amongst subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization|28 days||||days||Standard Deviation|Mean
2688111|NCT01335932|Secondary|Number of Ventilator-free Days Among Subjects by Day 28|Number of ventilator-free days among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization|28 days||||days||Standard Deviation|Mean
2688112|NCT01335932|Secondary|Number of Mechanically Ventilated Days Among Subjects by Day 28|Number of mechanically ventilated days among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization|28 days||||days||Standard Deviation|Mean
2688113|NCT01335932|Secondary|Mortality Among Subjects Mechanically Ventilated From Day 7 to 14|Mortality among subjects by day 28 who are mechanically ventilated for at least 7 through 14 days after randomization|28 days||||events|||Number
2688114|NCT01335932|Secondary|Number of Hospital-free Days|Number of hospital-free days amongst subjects who survive at least 7 days after randomization|at 7 days post-randomization||||days||Standard Deviation|Mean
2688115|NCT01335932|Secondary|Number of Days in the Hospital|Number of days in the hospital amongst subjects who survive at least 7 days after randomization|at 7 days post-randomization||||days||Standard Deviation|Mean
2688116|NCT01335932|Secondary|Number of ICU-free Days|Number of ICU-free days amongst subjects who survive at least 7 days after randomization|at 7 days post-randomization||||days||Standard Deviation|Mean
2688117|NCT01335932|Secondary|Number of Days in the ICU|Number of days in the ICU amongst subjects who survive at least 7 days after randomization|at 7 days post-randomization||||days||Standard Deviation|Mean
2688118|NCT01335932|Secondary|Number of Ventilator-free Days|Number of ventilator-free days amongst subjects who survive at least 7 days after randomization|at 7 days post-randomization||||days||Standard Deviation|Mean
2688119|NCT01335932|Secondary|Number of Mechanical Ventilated Days|Number of mechanical ventilated days amongst subjects who survive at least 7 days after randomization|at 7 days post-randomization||||days||Standard Deviation|Mean
2688130|NCT01335932|Secondary|SF-36 Functional Assessment Mental Component on Day 1|SF-36 Mental Component Summary at 1 day post-randomization. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability|at 1 day post-randomization||||scores on a scale||Standard Deviation|Mean
2688131|NCT01335932|Secondary|SF-36 Functional Assessment Mental Component|Mental Component Summary at 180 days post-randomization. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability|at 180 days post-randomization||||scores on a scale||Standard Deviation|Mean
2688132|NCT01335932|Secondary|SF-36 Functional Assessment Physical Component|Physical Component Summary at 180 days post- randomization. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability|at 180 days post-randomization||||scores on a scale||Standard Deviation|Mean
2688133|NCT01335932|Secondary|Mortality at 180 Days|Mortality at 180 days post-randomization|at 180 days post-randomization||||Participants|||Count of Participants
2688134|NCT01335932|Secondary|Mortality|Mortality at 60 days post randomization|at 60 days post-randomization||||Participants|||Count of Participants
2688135|NCT01335932|Secondary|Bacteremia and/or Fungemia|Number of participants with bacteremia and/or fungemia|at 28 days post-randomization||||Participants|||Count of Participants
2688136|NCT01335932|Secondary|Duration of Mechanical Ventilation as Assessed by Ventilator Days|Number of days of mechanical ventilation duration as assessed by ventilator days|at 28 days post-randomization||||days||Standard Deviation|Mean
2688137|NCT01335932|Secondary|Duration of Mechanical Ventilation as Assessed by Ventilator Free Days|Number of days of mechanical ventilation duration as assessed by ventilator free days|at 28 days post-randomization||||days||Standard Deviation|Mean
2688138|NCT01335932|Secondary|Organ System Failure at 28 Days|Number of participants with organ system failure at 28 days|at 28 days post-randomization||||Participants|||Count of Participants
2688139|NCT01335932|Secondary|Length of Stay|Hospital days alive and not hospitalized by day 28|by 28 days post-randomization||||days||Standard Deviation|Mean
2688140|NCT01335932|Secondary|Length of Stay|Hospital days alive and not hospitalized by day 180|by 180 days post-randomization||||days||Standard Deviation|Mean
2688141|NCT01335932|Secondary|AUC Plasma Levels of Soluble ICAM-1|AUC Plasma levels of soluble ICAM-1 from day 0 to day 28|at 28 days post-randomization||||IU*day/mL||Standard Deviation|Mean
2688142|NCT01335932|Secondary|AUC Plasma Levels of TNF-a|AUC Plasma levels of TNF-a from day 0 to day 28|at 28 days post-randomization||||IU*day/mL||Standard Deviation|Mean
2688143|NCT01335932|Secondary|AUC Plasma Levels of IL-10|AUC Plasma levels of IL-10 from day 0 to day 28|at 28 days post-randomization||||IU*day/mL||Standard Deviation|Mean
2688144|NCT01335932|Secondary|AUC Plasma Levels of IL-8|AUC Plasma levels of IL-8 from day 0 to day 28|Day 0 to 28 days post-randomization||||IU*day/mL||Standard Deviation|Mean
2688145|NCT01335932|Secondary|AUC Plasma Levels of IL-6|AUC Plasma levels of IL-6 from day 0 to day 28|Day 0 to 28 days post-randomization||||IU*day/mL||Standard Deviation|Mean
2688146|NCT01335932|Secondary|Peak Plasma Levels of IL-6|Peak Plasma levels of IL-6 at day 28|at 28 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
2688147|NCT01335932|Secondary|Peak Plasma Levels of IL-8|Peak Plasma levels of IL-8 at day 28|at 28 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
2688148|NCT01335932|Secondary|Peak Plasma Levels of IL-10|Peak Plasma levels of IL-10 at day 28|at 28 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
2688149|NCT01335932|Secondary|Peak Plasma Levels of TNF-a|Peak Plasma levels of TNF-a at day 28|at 28 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
2688150|NCT01335932|Secondary|Peak Plasma Levels of Soluble ICAM-1|Peak Plasma levels of soluble ICAM-1 from day 0 to day 28|Day 0 to 28 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
2688151|NCT01335932|Secondary|Plasma Levels of Soluble ICAM-1|Plasma levels of soluble ICAM-1 at day 7|at 7 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
2688152|NCT01335932|Secondary|Plasma Levels of Soluble ICAM-1|Plasma levels of soluble ICAM-1 at day 28|at 28 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
2688153|NCT01335932|Secondary|Plasma Levels of IL-8|Plasma levels of IL-8 at day 28|at 28 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
2688154|NCT01335932|Secondary|Plasma Levels of IL-6|Plasma levels of IL-6 at day 28|at 28 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
2688155|NCT01335932|Secondary|Plasma Levels of TNF a|Plasma levels of TNF a from day 0 to day 28|Day 0 to 28 days post-randomization|Cytokines are summarized on a log 10 scale. When the logged value is negative, the raw value would be less than 1.|||log 10 pg/mL||Standard Deviation|Mean
2688156|NCT01335932|Secondary|Plasma Levels of TNF a|Plasma levels of TNF a at day 7.Cytokines are summarized on log 10 scale. When logged value is negative, the raw value would be less than 1.|at 7 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
2688157|NCT01335932|Secondary|Plasma Levels of IL-8|Levels of IL-8 in plasma at day 7|at 7 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
2688158|NCT01335932|Secondary|Plasma Levels of IL-6|Plasma levels of IL-6.|at 7 days post-randomization||||log 10 pg/mL||Standard Deviation|Mean
2688159|NCT01335932|Secondary|BAL Levels of TNFa|Levels of TNFa in BALs at day 7|at 7 days post-randomization|The protocol was modified to remove the inclusion of BALs, thus these numbers reflect the total BALs performed prior to the modification.|||log 10 pg/mL||Standard Deviation|Mean
2688160|NCT01335932|Secondary|BAL Levels of IL-8|Levels of IL-8 in BALs at day 7|at 7 days post-randomization|The protocol was modified to remove the inclusion of BALs, thus these numbers reflect the total BALs performed prior to the modification.|||log 10 pg/mL||Standard Deviation|Mean
2688167|NCT01335932|Secondary|SF-36 Health Survey|Physical Component Summary of SF-36. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.|at 1 day post-randomization||||scores on a scale||Standard Deviation|Mean
2688168|NCT01335932|Secondary|Grade 3 AEs or Higher|Number of patients with greater than one AE of grade 3 or more|by 35 days post-randomization||||Participants|||Count of Participants
2688169|NCT01335932|Secondary|CMV Disease|Need to be biopsy-proven|by 180 days post-randomization||||Participants|||Count of Participants
2688170|NCT01335932|Secondary|Number of Days Alive and Not in the ICU|Number of ICU days alive and not in the ICU by day 28|by 28 days post-randomization||||days||Standard Deviation|Mean
2688171|NCT01335932|Secondary|Number of Participants With Organ System Failure at 14 Days|Number of participants experiencing organ system failure at 14 days|at 14 days post-randomization||||Participants|||Count of Participants
2688172|NCT01335932|Secondary|BAL Levels of IL-6|Levels of IL-6 from BALs at 7 days post-randomization|at 7 days post-randomization|The protocol was modified to remove the inclusion of BALs, thus these numbers reflect the total BALs performed prior to the modification.|||log 10 pg/mL||Standard Deviation|Mean
2688173|NCT01335932|Secondary|Number of Participants With CMV Reactivation at 28 Days in Plasma|Number of participants in baseline negatives with CMV reactivation at any level at day 28|at 28 days post-randomization||||Participants|||Count of Participants
2688174|NCT01335932|Primary|Serum IL-6 Level|Change between baseline and 14 days post-randomization between placebo & ganciclovir groups|Baseline and Day 14||||pg/mL||Standard Deviation|Mean
2688175|NCT01335867|Secondary|Cocaine Withdrawal Severity|Measure of cocaine withdrawal severity will include Cocaine Selective Severity Assessment scores. Minimum score is 0 Maximum score is 119 Higher score is indicative of worse cocaine withdrawal symptoms.|8 weeks|subjects receiving vigabatrin or placebo who were available at the end of the trial to provide data.|||score on a scale||Standard Deviation|Mean
2688176|NCT01335867|Secondary|Disease Severity and Improvement|Number of subjects in each group rated as improved or very much improved at the end of the trial|8 weeks||||Participants|||Count of Participants
2688177|NCT01335867|Secondary|Measures of Cocaine Craving|Measures of cocaine craving at the end of the trial will be measured using the Brief Substance Craving Ccale. Craving intensity + Craving frequency + Craving Duration each measured on a 4 point scale. Sum of the three scales was overall craving composite. Higher numbers meaning greater craving. Maximum score 12 minimum 0.|8 weeks|subjects receiving vigabatrin or placebo who were available at the end of the trial to provide data.|||score on a scale||Standard Deviation|Mean
2688178|NCT01335867|Primary|Proportion of Heavy Drinking Days|The primary outcome measure for reduction in alcohol use will be recorded using the Timeline Followback method.|8 weeks||||proportion of heavy drinking days||Standard Deviation|Mean
2688179|NCT01335867|Primary|Number of Participants With a Reduction in Cocaine Use|The primary outcome measure for reduction in cocaine use will be the number of benzoylecgonine (BE) negative urine samples. The main outcome is the number of participants in each group who reported all BE negative urine samples in the last three weeks of the trial.|last 3 weeks of the trial||||participants|||Number
2688180|NCT01335789|Primary|Stress (as Measured by Subjective Report)|Subjective report of stress was measured using a 0-10 Likert Scale (0=not at all, 10=extremely). Reported here is subjective stress level 5 minutes following exposure to the Trier Social Stress Task (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.|5 minutes following Trier Social Stress Task completion||||units on a scale||95% Confidence Interval|Mean
2688181|NCT01335789|Secondary|Craving (as Measured by the Marijuana Craving Questionnaire)|The MCQ is intended to measure marijuana craving in adults. It measures symptoms on four subscales: expectancy, purposefulness, emotionality, and compulsivity. The scale rates individual items from 1-7 with a composite scoring range of 12-84 and possible subscale scoring range of 3-21. Reported here is MCQ composite score 5 minutes following Trier Social Stress Task exposure (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.|5 minutes following Trier Social Stress Task completion||||units on a scale||95% Confidence Interval|Mean
2688182|NCT01335789|Primary|Stress (as Measured by Cortisol)|Salivary cortisol samples were collected via passive drool to provide empirical assessment of stress reactivity. Reported here is salivary cortisol level 5 minutes following Trier Social Stress Task exposure (approximately 60 minutes post study drug/placebo administration). Trier Social Stress Task is a psychosocial laboratory stress task in which subjects deliver a speech and perform a math problem in front of a stranger audience.|5 minutes following Trier Social Stress Task completion||||nmol/L||95% Confidence Interval|Mean
2688183|NCT01335750|Primary|Corneal Staining Area|Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit.|Baseline, 2 Hour Period, 4 Hour Period|Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit.|||units on a scale||Standard Deviation|Mean
2688184|NCT01335750|Primary|Corneal Staining Severity|Severity of staining was recorded for each region using a scale of 0-none to 4-patch >/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit.|Baseline, 2 Hour Period, 4 Hour Period|Severity of staining was recorded for each region using a scale of 0-none to 4-patch >/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit.|||units on a scale||Full Range|Mean
2688185|NCT01335750|Secondary|Subjective Dryness|Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)|Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours|Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)|||units on a scale||Standard Deviation|Mean
2688190|NCT01335698|Secondary|Area Under the Concentration-Time Curve [AUC(TAU)]|To describe the PK profile of ATV powder formulation with RTV in pediatric subjects weighing 25 - < 35 kg and/or 6 to < 11 years of age and for the new 5 - < 10 kg cohort (200 mg ATV and 80 mg RTV) in terms of ATV AUC|Baseline to Week 2||||ng.h./mL||Standard Deviation|Mean
2688191|NCT01335698|Secondary|Minimum Plasma Concentration (Cmin)|To describe the PK profile of ATV powder formulation with RTV in pediatric subjects weighing 25 - < 35 kg and/or 6 to < 11 years of age and for the new 5 - < 10 kg cohort (200 mg ATV and 80 mg RTV) in terms of ATV Cmin|Baseline to Week 2||||ng/mL||Standard Deviation|Mean
2688192|NCT01335698|Secondary|Maximum Observed Plasma Concentration (Cmax)|To describe the PK profile of ATV powder formulation with RTV in pediatric subjects weighing 25 - < 35 kg and/or 6 to < 11 years of age and for the new 5 - < 10 kg cohort (200 mg ATV and 80 mg RTV) in terms of ATV Cmax|Baseline to Week 2||||ng/mL||Standard Deviation|Mean
2688193|NCT01335698|Secondary|Number of Participants With Emergent Genotypic Substitutions on ATV Powder Through Week 48|Newly emergent substitutions are on-treatment substitutions that were not detected at baseline.Viral rebound in the resistance analysis was defined as: Less than a 1 log10 drop from baseline in plasma HIV RNA level by Week 16, confirmed by a second plasma HIV RNA level redrawn within 2 and 4 weeks from original sample. Or, a plasma HIV RNA level >200 c/mL after Week 24, confirmed by a second plasma HIV RNA level redrawn within 2 and 4 weeks from original sample. Or, repeated plasma HIV RNA level ≥50 c/mL after Week 48. Viral rebound was defined as a plasma HIV RNA level ≥400 c/mL at any time in a patient who had previously achieved a plasma HIV RNA level <50 c/mL. Or, a plasma HIV RNA level ≥50 c/mL and <1,000 c/mL followed by a return to virologic suppression was considered a viral blip and not a viral rebound. NRTI=nucleoside reverse transcriptase inhibitor|Baseline through Week 48|All participants with virologic failure.|||Participants|||Number
2688194|NCT01335698|Secondary|CD4 Cell Count Changes From Baseline on ATV Powder|CD4 cell count change from baseline using observed values|Baseline to Weeks 24 and 48|All participants with both baseline and time point results|||Cells/mm^3||Standard Error|Mean
2688195|NCT01335698|Secondary|Mean Change From Baseline in CD4 Percent on ATV Powder|Change in CD4 percent using observed values|Baseline to Weeks 24 and 48|All participants with both baseline and time point results; n=number of participants evaluable at time point|||Percent Change||Standard Error|Mean
2688196|NCT01335698|Secondary|Mean Change From Baseline in HIV RNA on ATV Powder|Human immunodeficiency virus ribonucleic acid (HIV RNA) change from baseline using observed values|Baseline to Weeks 24 and 48|All participants who received at least 1 dose of study drug. n=participants with both baseline and time point results|||Log copies per millileter||Standard Error|Mean
2688197|NCT01335698|Secondary|Number of Participants With HIV RNA <50 Copies/mL and <400 Copies/mL in the Week 24 Atazanavir Powder Cohort and the Eligible Week 48 Atazanavir Powder Cohort|Virologic success includes patients with HIV RNA <50 copies/mL. Two cohorts were assessed: The Atazanavir Powder Cohort=patients who received treatment and did not switch to capsule before analysis Week 24 or before their HIV RNA Week 24 assessment, and the Eligible Week 48 Atazanavir Powder Cohort=patients who initiated study treatment at least 48 weeks before last person last visit and did not switch to capsule before analysis Week 48 or before their HIV RNA Week 48 assessment.|Day 1 of treatment to weeks 24 and 48|For efficacy of atazanavir powder to Week 24: Atazanavir Powder Cohort. For efficacy of atazanavir powder efficacy to Week 48 (n): Eligible Week 48 Atazanavir Powder Cohort|||Participants|||Number
2688198|NCT01335698|Primary|Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder|Criteria of the Division of AIDS for grading the severity of adult and pediatric adverse events as follows: Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=potentially life-threatening. Neutrophils (absolute) (adult and infants >7 days): Gr 1=1.000-1300/mm^3; Gr 2=750-999 mm^3; Gr 3=500-749 mm^3; Gr 4= <500 mm^3. Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase: Gr 1=1.25-2.5*upper limit of normal (ULN); Gr 2=2.6-5.0*ULN; Gr 3=5.1-10.0*ULN; Gr 4= >10.0*ULN. Bilirubin, total (adults and infants >14 days): Gr 1=1.1-1.5*ULN; Gr 2=1.6-2.5*ULN; Gr 3=2.6-5.0*ULN; Gr 4= >5.0*ULN. Lipase: Gr 1=1.1-1.5*ULN; Gr 2=1.6-3.0*ULN; Gr 3=3.1-5.0*ULN; Gr 4= >5.0*ULN. Bicarbonate, serum low: Gr 1=16.0 mEq/L-<lower limit of normal; Gr 2=11.0-15.9 mEq/L; Gr 3=8.0-10.9 mEq/L; Gr 4= <8 mEq/L. By criteria of the World Health Organization: Amylase: Gr 1=1.0-1.39*ULN; Gr 2=1.40-2.09*ULN; Gr 3.=2.10-5.0*ULN; Gr 4= >5.0*ULN.|Day one to week 300 (approximately 22-Jan-2018)|All participants who received at least 1 dose of study drug. n=number of participants evaluable|||Participants|||Number
2688199|NCT01335698|Primary|Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder|The CDC disease staging system assesses the severity of HIV disease by CD4 cell counts and by the presence of specific HIV-related conditions. CD4 counts are classified as 1: ≥500 cells/µL, 2: 200-499 cells/µL, and 3: <200 cells/µL. Children with HIV infection are also classified in each of several categories. Category N: Not symptomatic. Category A: Mildly symptomatic. Category B: Moderately symptomatic. Category C: Severely symptomatic.|Day one to week 300 (approximately 22-Jan-2018)|All participants who received at least 1 dose of study drug.|||Participants|||Number
2688200|NCT01335698|Primary|Number of Participants Who Experienced a SAE on ATV Powder|SAE= any of the the following: is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event (defined as a medical event(s) that may not be immediately life threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the subject or may require intervention [eg, medical, surgical] to prevent one of the other serious outcomes listed in the definition above.) Examples of such events include, but are not limited to, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization|Day one to week 300 (approximately 22-Jan-2018)||||participants|||Number
2688201|NCT01335698|Primary|Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.|Day one to week 300 (approximately 22-Jan-2018)|All participants who received at least 1 dose of study drug|||Participants|||Number
2688203|NCT01335685|Secondary|Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.|From first dose of study drug through 30 days after last dose of study drug or until the start of subsequent antineoplastic therapy for up to 5.6 years|The safety population consisted of participants who received at least 1 dose of any study drug.|||participants|||Number
2688204|NCT01335685|Secondary|Overall Survival (Phase 2)|Overall Survival is the time in months from start of study treatment to date of death due to any cause.|From date of enrollment to date of death, approximately 5.5 years (Approximate median follow-up: 43.6 months)|The safety population consisted of participants who received at least 1 dose of any study drug.|||months||95% Confidence Interval|Median
2688205|NCT01335685|Secondary|Progression Free Survival (Phase 2)|Progression Free Survival is defined as time in months from start of study treatment to first documentation of objective tumor progression per investigator assessment or up to death due to any cause, whichever occurs first. Per IMWG criteria, progressive disease requires any 1 or more of following: Increase of ≥25% from nadir in serum M-component and/or (absolute increase must be ≥0.5 g/dL), urine M-component and/or (absolute increase must be ≥200 mg/24 hour. Participants without measurable serum+urine M-protein levels: difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: absolute % must be ≥10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.85 mmol/L) that can be attributed solely to plasma cell proliferative disorder.|From the date of enrollment to the date of the first documented disease progression or death due to any cause for up to 5.5 years|The safety population consisted of participants who received at least 1 dose of any study drug.|||months||95% Confidence Interval|Median
2688206|NCT01335685|Secondary|Time to Next Therapy (Phase 2)|Time to Next Therapy is defined as time from the date of enrollment to the date of subsequent antineoplastic therapy.|From the date of enrollment to the date of subsequent antineoplastic therapy for up to 5.5 years|Time to next therapy was not analyzed due to the change in the planned analysis.||||||
2688207|NCT01335685|Secondary|Time to Progression (TTP) (Phase 2)|TTP is defined as time from date of enrollment to date of first documented disease progression (PD). Per IMWG criteria, progressive disease requires any 1 or more of following: Increase of ≥25% from nadir in serum M-component and/or (absolute increase must be ≥0.5 g/dL), urine M-component and/or (absolute increase must be ≥200 mg/24 hour. Participants without measurable serum+urine M-protein levels: difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dL. Bone marrow plasma cell percentage: absolute % must be ≥10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas. Development of hypercalcemia (corrected serum calcium >11.5 mg/dL or 2.85 mmol/L) that can be attributed solely to plasma cell proliferative disorder.|From the date of enrollment to the date of the first documented disease progression for up to 5.5 years|The safety population consisted of participants who received at least 1 dose of any study drug.|||months||95% Confidence Interval|Median
2688208|NCT01335685|Secondary|Duration of Response (DOR) (Phase 2)|DOR is defined as time of first documentation of a confirmed PR or better response to first documented PD or start of alternative therapy. DOR was presented for those achieving CR+VGPR+PR. Per IMWG criteria, CR:1)Negative immunofixation on serum+urine, 2)Disappearance of any soft tissue plasmacytomas, 3)< 5% plasma cells in bone marrow. VGPR: Serum+urine M-protein detectable by immunofixation but not on electrophoresis/ 90% or >reduction in serum M-protein + urine M-protein level < 100 mg/ 24-hour. PR:1)≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24-hour. If serum+urine M-protein are unmeasurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required. Else, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition, if present at baseline, a ≥50% reduction in size of soft tissue plasmacytomas is required.|From the time from the date of first documentation of PR or better to the date of first documented disease progression for up to 5.5 years|The safety population consisted of participants who received at least 1 dose of any study drug.|||months||95% Confidence Interval|Median
2688209|NCT01335685|Secondary|Time to First Response (Phase 2)|Response is defined as CR, VGPR and PR. Per IMWG criteria, CR:1)Negative immunofixation on serum+urine, 2)Disappearance of any soft tissue plasmacytomas, 3)< 5% plasma cells in bone marrow. VGPR: Serum+urine M-protein detectable by immunofixation but not on electrophoresis/ 90% or >reduction in serum M-protein + urine M-protein level < 100 mg/ 24-hour. PR:1)≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24-hour. If serum+urine M-protein are unmeasurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required. Else, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition, if present at baseline, a ≥50% reduction in size of soft tissue plasmacytomas is required.|From the date of enrollment to the date of the first documented response for up to 5.5 years|The safety population consisted of participants who received at least 1 dose of any study drug.|||months||95% Confidence Interval|Median
2688221|NCT01335620|Secondary|Cerebral Function; Changes in Global Cognitive Z-score|"Cerebral function via cognitive testing before and after a switch in antiretroviral therapy to raltegravir.~Mean Scores from the eight tasks (NPZ-8) assessed were used to derive a global composite measure of neurocognitive function. The result shows the change before and after switch, an increase in z-score represents an improvement in cognitive function assessed by CogState battery, required approximately 10-15 min for completion."|6 months||||score on a scale||Standard Deviation|Mean
2688222|NCT01335620|Secondary|Cardiovascular Disease Markers|• To investigate cardiovascular disease markers before and after a switch in antiretroviral therapy to raltegravir.|6 months|No data collected||||||
2688223|NCT01335620|Primary|Changes in Haematology, Biochemistry and Virology Tests|full blood count, electrolytes and blood lipids will be measured at all visits to assess for changes through out the study. HIV viral load will also be measured to assess the efficacy of the medication at controlling the virus|6 months|No data collected||||||
2688224|NCT01335620|Primary|Drug Levels in Blood|rategravir concentration|Day 28||||ng/ml||95% Confidence Interval|Geometric Mean
2688210|NCT01335685|Secondary|Overall Response Rate (ORR)|ORR is defined as percentage of participants with overall response including CR, VGPR, and partial response (PR). Per IMWG criteria, CR:1)Negative immunofixation on serum and urine, 2)Disappearance of any soft tissue plasmacytomas, 3)< 5% plasma cells in bone marrow. VGPR: Serum+urine M-protein detectable by immunofixation but not on electrophoresis/ 90% or >reduction in serum M-protein + urine M-protein level < 100 mg/ 24-hour. PR:1)≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24-hour. If serum+urine M-protein are unmeasurable, ≥50% decrease in difference between involved and uninvolved FLC levels is required. If serum+urine M-protein are unmeasurable and serum free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition, if present at baseline, a ≥50% reduction in size of soft tissue plasmacytomas is required.|Day 1 of every other cycle from Day 1 of Cycle 2 (each cycle of 28 days) up to 61 cycles, at end of treatment (Up to 5.5 years)|The response-evaluable population is defined as participants who received at least 5 of 8 MLN9708 doses in Arm A, at least 2 of 3 MLN9708 doses in Arm B, at least 4 of 5 MLN9708 doses in Arm C, or at least 3 of 4 MLN9708 doses in Arm D and had measurable disease at baseline and at least 1 post-baseline response assessment.|||percentage of participants||95% Confidence Interval|Number
2688211|NCT01335685|Secondary|Observed Accumulation Ratio for AUCtau (Rac) (Phase 1)|Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1.|Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D|The PK population consisted of all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters.|||ratio||Standard Deviation|Mean
2688212|NCT01335685|Secondary|Terminal Phase Elimination Half-life (T1/2) for Ixazomib (Phase 1)|Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.|Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D|The PK population consisted of all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters.|||hours||Standard Deviation|Mean
2688213|NCT01335685|Secondary|Terminal Elimination Rate Constant (λz) for Ixazomib (Phase 1)|Terminal elimination rate constant, calculated as the negative of the slope of the log-linear regression of the natural logarithm concentration-time curve during the terminal phase.|Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D|The PK population consisted of all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters.|||1/hour||Standard Deviation|Mean
2688214|NCT01335685|Secondary|AUCtau: Area Under the Plasma Concentration-time Curve Over the Dosing Interval for Ixazomib (Phase 1)||Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D|The PK population consisted of all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters.|||hr*ng/mL||Standard Deviation|Mean
2688215|NCT01335685|Secondary|Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Ixazomib (Phase 1)||Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D|The PK population consisted of all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters.|||hours||Full Range|Median
2688216|NCT01335685|Secondary|Cmax: Maximum Observed Plasma Concentration for Ixazomib (Phase 1)||Pre-dose on Day 1 and at multiple timepoints (up to 8 hours) on Day 11 for Arm A, Day 15 for Arm B and Day 29 for Arms C and D|The pharmacokinetics (PK) population consisted of all participants who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib PK parameters.|||ng/mL||Standard Deviation|Mean
2688217|NCT01335685|Secondary|Time of Occurrence of Emax (TEmax) (Phase 1)|Whole blood 20S proteasome inhibition parameters|At multiple time points during Cycles 1-3 of each phase and arm of the study, throughout approximately 84-126 days depending on the arm of the study|The efficacy endpoint of maximum inhibition rate was not performed due to the change in the planned analysis.||||||
2688218|NCT01335685|Secondary|Maximum Inhibition Rate (Emax) (Phase 1)|Whole blood 20S proteasome inhibition parameters|At multiple time points during Cycles 1-3 of each phase and arm of the study, throughout approximately 84-126 days depending on the arm of the study|Due to the change in the planned analysis, the efficacy endpoint of maximum inhibition rate was not performed.||||||
2688219|NCT01335685|Primary|Very Good Partial Response (VGPR) or Better Response Rate (Phase 2)|VGPR or better response rate is defined as percentage of participants with a complete response (CR) and very good partial response (VGPR). Per International Myeloma Working Group Uniform Response Criteria (IMWG), CR: 1) Negative immunofixation on the serum and urine, 2) Disappearance of any soft tissue plasmacytomas and 3) < 5% plasma cells in bone marrow. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hour.|Day 1 of every other cycle from Day 1 of Cycle 2 (each cycle of 28 days) until death (Up to 5.5 years)|The response-evaluable population is defined as participants who received at least 5 of 8 MLN9708 doses in Arm A, at least 2 of 3 MLN9708 doses in Arm B, at least 4 of 5 MLN9708 doses in Arm C, or at least 3 of 4 MLN9708 doses in Arm D and had measurable disease at baseline and at least 1 post-baseline response assessment.|||percentage of participants|||Number
2688220|NCT01335685|Primary|Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Ixazomib (Phase 1)|The RP2D is the maximum tolerated dose (MTD) or less. The MTD is defined as the dose range at which ≤ 1 of 6 evaluable participants experience dose limiting toxicities (DLT) within the first 28 days of treatment (end of Cycle 1).|Cycle 1, phase 1 (Up to 42 days)|Dose Limiting Toxicity population included participants who received at least 80% of doses of MLN9708 and melphalan during Cycle 1 in Arms A or all doses of MLN9708 and melphalan during Cycle 1 in Arm B, C, D, or experience a DLT in Cycle 1 in the phase 1 dose escalation portion.|||mg|||Number
2688295|NCT01335191|Primary|Anti-Tat Antibody Titer|ELISA based chemiluminescent assay to determine the anti-Tat antibody response|54 weeks|all subjects enrolled|||ng/mL||Full Range|Mean
2710803|NCT01167829|Secondary|Mean SHGB Concentration||baseline & day 9|per protocol|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
2688225|NCT01335542|Primary|"The Primary Outcome is Time Until a Patient is Ready for Discharge."|"The primary outcome is time until a patient is ready for discharge. Discharge criteria are:~PCA (if present) has been discontinued~Not experiencing moderate or severe nausea (within last 4 hours).~Solid food diet~Able to urinate (Foley catheter removed)~Pain: NRS <4.~Surgical wound dry~No acute medical problems~Physical Therapy Criteria~Independently transfer from supine to sit, from sitting to standing~Ambulate 40 ft. without assistance~Extension range of motion (< 10 degrees)"|Participants will be followed for the duration of their hospital stay, an expected average of 3 days||||days||Inter-Quartile Range|Mean
2688226|NCT01335477|Secondary|Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||mmol/min/kPa||Standard Error|Mean
2688227|NCT01335477|Secondary|Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks|Means presented are the adjusted means. Adjusted mean is based on all analyzed patients in the model (not only patients with a change from baseline to week 52)|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percent of oxygen saturation||Standard Error|Mean
2688228|NCT01335477|Secondary|Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death or lung transplant or qualifying for lung transplant over 52 weeks are reported. A patient was considered qualifying for lung transplant by the investigator if he or she fulfilled the following criteria:~FVC <45% predicted or Carbon monoxide diffusion capacity (DL(CO)) <30% pred or Oxygen saturation on pulse oximetry (SpO2) <88% at rest, at sea level (to be adapted for other heights).~These criteria were evaluated by investigators judgement. Failure is the proportion of patients who died or had lung transplant or qualified for lung transplant over 52 weeks (373 days time-period)."|52 weeks|Treated Set|||percentage of participants|||Number
2688229|NCT01335477|Secondary|Time to Death or Lung Transplant Over 52 Weeks|Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experience event (death or lung transplant) before or at 372 days after randomisation or last contact date (whichever occurs first) are reported. Failure is the proportion of patients who died or had lung transplant over 52 weeks (373 days time-period).|52 weeks|Treated Set|||percentage of participants|||Number
2688230|NCT01335477|Secondary|Time to On-treatment Death|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not die before or at last trial medication intake + 28 days were censored at last trial medication intake + 28 days and reported.~Failure is the the proportion of patients who died on-treatment."|52 weeks|Treated Set|||percentage of participants|||Number
2688231|NCT01335477|Secondary|Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death due to respiratory causes before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the the proportion of patients who died due to respiratory causes over 52 weeks (373 days time-period)."|52 weeks|Treated Set|||percentage of participants|||Number
2688232|NCT01335477|Secondary|Time to Death Over 52 Weeks|"Due to rare events, the median of time to event is not calculable, thus the percentages of patients who did or did not experienced death before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the proportion of patients who died over 52 weeks (373 days time-period)."|52 weeks|Treated Set|||percentage of participants|||Number
2688233|NCT01335477|Secondary|Risk of an Acute IPF Exacerbation Over 52 Weeks|The incidence rate of exacerbations (calculated as the number of patients with at least 1 acute IPF exacerbation divided by the total number of years at risk in years*100)|52 weeks|Treated Set|||Participants/Year *100|||Number
2688234|NCT01335477|Secondary|Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs)|The EuroQol 5-dimensional Health State is based on a visual analog scale (EQ-VAS) representing the general patient's health state labelled from 100 (best imaginable health state) to 0 (worst imaginable health state). A higher score indicating a better health state. Change from baseline is calculated as the difference between health state at week 12, 24 and 52 respectively and health state at baseline as measured by the scale.|baseline, 12 weeks, 24 weeks and 52 weeks|Treated Set|||points on a scale||Standard Deviation|Mean
2688235|NCT01335477|Secondary|Proportion of Patient's Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)|Patient's Global Impression of Change (PGI-C) responders are defined as 'Very much better'/ 'Much better'/ 'A little better'/ 'No change'.|52 weeks|Treated Set|||percentage of participants||95% Confidence Interval|Number
2688236|NCT01335477|Secondary|Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)|"The cough domains of the Cough and Sputum Assessment Questionnaire (CASA- Q) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
2688237|NCT01335477|Secondary|Change From Baseline in Cough Symptom Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)|"The cough domains of the Cough and Sputum Assessment Questionnaire (CASAQ(CD)) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
2698569|NCT01255163|Primary|Number of Participants With Incidence of Nausea|Tolerability of exenatide (nausea is the most common expected adverse event of exenatide)|18 months||||Participants|||Count of Participants
2688238|NCT01335477|Secondary|Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)|"Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
2688239|NCT01335477|Secondary|Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ-I is the IPF specific version of SGRQ comprises of selected items from the SGRQ divided into three components, Symptoms, Activity and Impact. Each component is scored separately. The weights for all items with a positive responses are summed and the weights from missed items are deducted from the maximum possible weight for the total score.~The total score is calculated by dividing the summed weights from positive items in the questionnaire by maximum possible weight for all items in the questionnaire. The total score can range from 0 to 100 with a lower score denoting a better health-related quality of life. Change from baseline is calculated as the difference between total score at week 52 and total score at baseline as measured by the scale."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
2688240|NCT01335477|Secondary|Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Activity score is a sub-component of SGRQ total score and concerned with activities that cause or are limited by breathlessness. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better activity-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
2688241|NCT01335477|Secondary|Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Impact score is a sub-component of SGRQ total score and covers a range of aspects concerned with social functioning and psychological disturbances resulting from airway disease. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better impact-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
2688242|NCT01335477|Secondary|Change From Baseline in SGRQ Symptom Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Symptom score is a sub-component of SGRQ total score and is concerned with the effect of respiratory symptoms, their frequency and severity. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better symptom-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
2688243|NCT01335477|Secondary|Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)|"Proportion of SGRQ responders at 52 weeks.~Responders defined as <= -4 points change in change from baseline in SGRQ total score at 52 weeks."|baseline and 52 weeks|Treated Set|||percentage of participants||95% Confidence Interval|Number
2688244|NCT01335477|Secondary|Proportion of FVC Responders Using 5% Threshold at 52 Weeks|Proportion of FVC responders using 5% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 5% and with an FVC evaluation at 52 weeks.|52 weeks|Treated Set|||percentage of participants||95% Confidence Interval|Number
2688245|NCT01335477|Secondary|FVC Responders Using 10% Threshold at 52 Weeks|FVC responders using 10% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 10% and with an FVC evaluation at 52 weeks.|52 weeks|Treated Set|||percentage of participants||95% Confidence Interval|Number
2688246|NCT01335477|Secondary|Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold|Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 10% threshold (decrease by 10%, increase by >10%, and change within ≤10%)|Baseline and 52 weeks|Treated Set (for patients with change from baseline in FVC (% predicted) at Week 52)|||percentage of participants|||Number
2688247|NCT01335477|Secondary|Absolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold|Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 5% threshold (decrease by >5%, increase by >5%, and change within ≤5%).|Baseline and 52 weeks|Treated Set (for patients with change from baseline in FVC (% predicted) at Week 52)|||percentage of participants|||Number
2688248|NCT01335477|Secondary|Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks|Percentage change from baseline in FVC (% predicted) at 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percent change||Standard Error|Mean
2688249|NCT01335477|Secondary|Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||%predicted||Standard Error|Mean
2688250|NCT01335477|Secondary|Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks|Percentage change from baseline in FVC over 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percent change||Standard Error|Mean
2688251|NCT01335477|Secondary|Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||mL||Standard Error|Mean
2688252|NCT01335477|Secondary|Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation|"Due to rare events, the median of time to event is not calculable, thus the percentages of patients with (IPF) exacerbation are reported and represented as a key secondary endpoint. An acute exacerbation (reported as an AE by the investigator) was defined as follows:~Otherwise unexplained clinical features including all of the following:~Unexplained worsening or development of dyspnoea within 30 days New diffuse pulmonary infiltrates on chest X-ray, and/or new HRCT parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit Exclusion of infection as per routine clinical practice and microbiological studies Exclusion of alternative causes as per routine clinical practice including left heart failure, pulmonary embolism and identifiable cause of acute lung injury.~Failure is the proportion of patients with at least one acute IPF exacerbation over 52 weeks, based on all investigator-reported AEs ."|52 weeks|Treated Set|||percentage of participants|||Number
2688253|NCT01335477|Secondary|Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks|"This is a key secondary endpoint. SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact.~The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.~Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
2688254|NCT01335477|Primary|Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks.|"Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.~For this endpoint reported means represent the adjusted rate."|52 weeks|Treated Set|||mL/year||Standard Error|Mean
2688255|NCT01335464|Secondary|Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||mmol/min/kPa||Standard Error|Mean
2688256|NCT01335464|Secondary|Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks|Means presented are the adjusted means. Adjusted mean is based on all analyzed patients in the model (not only patients with a change from baseline to week 52)|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percent of oxygen saturation||Standard Error|Mean
2688257|NCT01335464|Secondary|Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death or lung transplant or qualifying for lung transplant over 52 weeks are reported. A patient was considered qualifying for lung transplant by the investigator if he or she fulfilled the following criteria:~FVC <45% predicted or Carbon monoxide diffusion capacity (DL(CO)) <30% pred or Oxygen saturation on pulse oximetry (SpO2) <88% at rest, at sea level (to be adapted for other heights).~These criteria were evaluated by investigators judgement. Failure is the proportion of patients who died or had lung transplant or qualified for lung transplant over 52 weeks (373 days time-period)."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
2688258|NCT01335464|Secondary|Time to Death or Lung Transplant Over 52 Weeks|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experience event (death or lung transplant) before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the proportion of patients who died or had lung transplant over 52 weeks (373 days time-period)."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
2688259|NCT01335464|Secondary|Time to On-treatment Death|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not die before or at last trial medication intake + 28 days were censored at last trial medication intake + 28 days and reported.~Failure is the the proportion of patients who died on-treatment."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
2688260|NCT01335464|Secondary|Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)|"Due to rare events, the median of time to event is not calculable, thus the percentages of participants who did or did not experienced death due to respiratory causes before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the the proportion of patients who died due to respiratory causes over 52 weeks (373 days time-period)."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
2688261|NCT01335464|Secondary|Time to Death Over 52 Weeks|"Due to rare events, the median of time to event is not calculable, thus the percentages of patients who did or did not experienced death before or at 372 days after randomisation or last contact date (whichever occurs first) are reported.~Failure is the proportion of patients who died over 52 weeks (373 days time-period) ."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
2688262|NCT01335464|Secondary|Risk of an Acute IPF Exacerbation Over 52 Weeks|The incidence rate of exacerbations (calculated as the number of patients with at least 1 acute IPF exacerbation divided by the total number of years at risk in years*100)|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||Participants/Year *100|||Number
2688263|NCT01335464|Secondary|Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs)|The EuroQol 5-dimensional Health State is based on a visual analog scale (EQ-VAS) representing the general patient's health state labelled from 100 (best imaginable health state) to 0 (worst imaginable health state). A higher score indicating a better health state. Change from baseline is calculated as the difference between health state at week 12, 24 and 52 respectively and health state at baseline as measured by the scale.|baseline, 12 weeks, 24 weeks and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Deviation|Mean
2688264|NCT01335464|Secondary|Proportion of Patient's Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)|Patient's Global Impression of Change (PGI-C) responders are defined as 'Very much better'/ 'Much better'/ 'A little better'/ 'No change'.|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants||95% Confidence Interval|Number
2688265|NCT01335464|Secondary|Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks : Patient Reported Outcomes (PROs)|"The cough domains of the Cough and Sputum Assessment Questionnaire (CASA-Q) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
2688266|NCT01335464|Secondary|Change From Baseline in Cough Symptoms Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)|"The cough domains of the Cough and Sputum Assessment Questionnaire (CASAQ(CD)) assess the frequency and severity of cough and sputum and their impact on everyday life. It contains 4 domains cough/sputum symptom and impact with each scale ranging from 0 to 100 with lower scores indicating higher symptoms/impact levels (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
2688267|NCT01335464|Secondary|Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)|"Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
2688268|NCT01335464|Secondary|Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ-I is the IPF specific version of SGRQ comprises of selected items from the SGRQ divided into three components, Symptoms, Activity and Impact. Each component is scored separately. The weights for all items with a positive responses are summed and the weights from missed items are deducted from the maximum possible weight for the total score.~The total score is calculated by dividing the summed weights from positive items in the questionnaire by maximum possible weight for all items in the questionnaire. The total score can range from 0 to 100 with a lower score denoting a better health-related quality of life. Change from baseline is calculated as the difference between total score at week 52 and total score at baseline as measured by the scale."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
2688269|NCT01335464|Secondary|Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Activity score is a sub-component of SGRQ total score and concerned with activities that cause or are limited by breathlessness. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better activity-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on scale||Standard Error|Mean
2688270|NCT01335464|Secondary|Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)|"SGRQ Impact score is a sub-component of SGRQ total score and covers a range of aspects concerned with social functioning and psychological disturbances resulting from airway disease. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better impact-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
2688271|NCT01335464|Secondary|Change From Baseline in SGRQ Symptom Score at 52 Weeks: Patient Reported Outcomes (PROs)|"SGRQ Symptom score is a sub-component of SGRQ total score and is concerned with the effect of respiratory symptoms, their frequency and severity. This score calculated as summed weights ranges from 0 to 100 with lower score denoting a better symptom-related quality of life.~Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
2688272|NCT01335464|Secondary|Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)|"Proportion of SGRQ responders at 52 weeks~Responders defined as <= -4 points change in change from baseline in SGRQ total score at 52 weeks."|Baseline and 52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants||95% Confidence Interval|Number
2688273|NCT01335464|Secondary|Proportion of FVC Responders Using 5% Threshold at 52 Weeks|Proportion of FVC responders using 5% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 5% and with an FVC evaluation at 52 weeks.|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants||95% Confidence Interval|Number
2688274|NCT01335464|Secondary|FVC Responders Using 10% Threshold at 52 Weeks|FVC responders using 10% threshold at 52 weeks, defined as patients with absolute decline in FVC% predicted no greater than 10% and with an FVC evaluation at 52 weeks.|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants||95% Confidence Interval|Number
2688275|NCT01335464|Secondary|Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold|Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 10% threshold (decrease by 10%, increase by >10%, and change within ≤10%)|Baseline and 52 weeks|TS (for patients with change from baseline in FVC (%predicted) at Week 52)|||percentage of participants|||Number
2688276|NCT01335464|Secondary|Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold|Absolute categorical change of FVC (% predicted) by categories over 52 weeks - 5% threshold (decrease by >5%, increase by >5%, and change within ≤5%).|Baseline and 52 weeks|TS (for patients with change from baseline in FVC (%predicted) at Week 52)|||percentage of participants|||Number
2688277|NCT01335464|Secondary|Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks|Percentage change from baseline in FVC (% predicted) at 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)|||percent change||Standard Error|Mean
2688278|NCT01335464|Secondary|Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)|||% predicted||Standard Error|Mean
2688279|NCT01335464|Secondary|Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks|Percentage change from baseline in FVC over 52 weeks. Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)|||percent change||Standard Error|Mean
2688280|NCT01335464|Secondary|Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks|Means provided are the adjusted means and are based on all analysed patients in the model (not only patients with a change from baseline to week 52).|Baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)|||mL||Standard Error|Mean
2688281|NCT01335464|Secondary|Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation|"Due to rare events, the median of time to event is not calculable, thus the percentages of patients with (IPF) exacerbation are reported and represented as a key secondary endpoint. An acute exacerbation (reported as an AE by the investigator) was defined as follows:~Otherwise unexplained clinical features including all of the following:~Unexplained worsening or development of dyspnoea within 30 days~New diffuse pulmonary infiltrates on chest X-ray, and/or new HRCT parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the last visit~Exclusion of infection as per routine clinical practice and microbiological studies~Exclusion of alternative causes as per routine clinical practice including left heart failure, pulmonary embolism and identifiable cause of acute lung injury.~Failure is the proportion of patients with at least one acute IPF exacerbation over 52 weeks, based on all investigator-reported AEs ."|52 weeks|Treated Set (Only patients with observed cases (OC) values were analysed)|||percentage of participants|||Number
2688282|NCT01335464|Secondary|Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks|"This is a key secondary endpoint.~SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact.~The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.~Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at week 52)."|baseline and 52 weeks|TS (Only patients with observed cases (OC) values were analysed)|||points on a scale||Standard Error|Mean
2688283|NCT01335464|Primary|Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks|"Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test.~For this endpoint reported means represent the adjusted rate"|52 weeks|TS (Only patients with observed cases (OC) values were analysed)|||mL/year||Standard Error|Mean
2688284|NCT01335308|Secondary|Change in Physical Activity||2 years after enrollment||||Adjusted posttest hours per day||Standard Error|Mean
2688285|NCT01335308|Secondary|Sweetened Beverage Consumption||2 years after enrollment||||Adjusted posted test servings per day||Standard Error|Mean
2688286|NCT01335308|Secondary|Fruit/Vegetable Consumption||2 years after enrollment||||Post test adjuste, servings per day||Standard Error|Mean
2688287|NCT01335308|Primary|Child BMI Percentile||2 years after recruitment||||BMI Percentile||Standard Error|Mean
2688288|NCT01335230|Primary|Exploring the Role of Gut-associated Th17 in Microbial Translocation in HIV and HCV/HIV Coinfected Patients.|We measure gene transcription of the colon tissues (relative expression fold changes of gene transcription compared to control). No preselected criteria were used to assess the participants. Data were analyzed and compared among each group. Relative expression levels of LEAP-2 (Liver expressed anti-microbial peptide-2) in the four groups were shown in the table below. Detailed of other genes had been published in Shata MT, et al, J. Clin Pathology 2013, Nov 66(11):967-75. PMID 23940131, and Abdel-Hameed et al, J. Acquir Immune Defic Syndr. 2013 Jul 10 PMID: 23846566|One year|All the samples were analyzed for gene array transcriptions and cytokines profiles|||relative expression levels||Standard Deviation|Mean
2688289|NCT01335204|Secondary|Progression-free Survival (PFS)|Determination of progression-free survival in subjects treated with cabazitaxel + bavituximab for CRPC previously treated with docetaxel. PFS will be assessed continually during the entire study.|24+ weeks|This study terminated early, so outcomes were not analyzed.||||||
2688290|NCT01335204|Secondary|Number of With Grade 3 or 4 Toxicities|To document the toxicity of cabazitaxel + bavituximab therapy in CRPC patients previously treated with docetaxel. Toxicity will be assessed continually during the 24 wks of study therapy.|24 weeks||||grade 3 or 4 toxicities|||Number
2688291|NCT01335204|Secondary|Overall Survival|To estimate the overall survival in subjects with CRPC (previously treated with docetaxel) following cabazitaxel + bavituximab therapy. Overall survival will be assessed continually during the duration of the study.|24+ weeks|This study terminated early, so outcomes were not analyzed.||||||
2688292|NCT01335204|Secondary|Objective Response Rate by RECIST for Patients With Measurable Disease|To estimate the objective response rate from cabazitaxel + bavituximab therapy in CRPC patients previously treated with docetaxel. Objective response rate will be assessed at day 85, 169|24 weeks|This study terminated early, so outcomes were not analyzed.||||||
2688293|NCT01335204|Secondary|Measurement of PSA Response Rate|To estimate the PSA response rate from cabazitaxel + bavituximab therapy in CRPC patients previously treated with docetaxel. PSA response rate will be assessed at multiple time points during the 24 wks of study treatment.|24 weeks|This study terminated early, so outcomes were not analyzed.||||||
2688294|NCT01335204|Primary|Probability of Progression-free Survival at Day 85|The primary objective of this study is to determine the probability of progression-free survival (PFS) after 12 weeks of therapy in subjects with CRPC treated with cabazitaxel + bavituximab.|12 weeks|This study terminated early, so outcomes were not analyzed.||||||
2688296|NCT01335061|Secondary|Incidence of Less Than Expected Therapeutic Effect (LETE)|"The following criteria are the definitions for LETE in this study: 1. LETE in the On-Demand Setting: LETE occurs in the on-demand setting if 2 successive No Response ratings are recorded after 2 successive BeneFIX drug infusions in the absence of confounding factors. 2. LETE in the Prophylaxis Setting: LETE occurs in the prophylaxis setting if there is a spontaneous bleed within 48 hours (≤ 48 hours) after a regularly scheduled prophylactic dose of BeneFIX in the absence of confounding factors. 3. LETE (Low Recovery): LETE can also be lower than expected recovery of FIX in the opinion of the investigator following infusion of BeneFIX in the absence of confounding factors. Each reported occurrence of low recovery LETE was listed."|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study.|||Percentage of occurence|||Number
2688297|NCT01335061|Secondary|Total Factor Consumption.|The total amount (IU) infused for each infusion recorded were summed to calculate the total factor consumption for each participant. For each infusion, IU/kg was calculated, using the most recently recorded weight measurement and the total factor consumption, divided by number of infusions, and was summarized similarly to average infusion dose (IU). Annualized TFC by weight was reported. Annualized TFC by weight = (Total IU/kg / treatment interval duration)*365.25.|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study.|||IU/Kg||Standard Deviation|Mean
2688298|NCT01335061|Secondary|Average Infusion Dose.|The mean dose by per infusion by weight (IU/kg) was reported for both prophylaxis and on demand infusions|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study.|||IU/Kg||Standard Deviation|Mean
2688299|NCT01335061|Secondary|Number of Breakthrough (Spontaneous/Non-Traumatic) Bleeds Within 48 Hours of a Prophylaxis Dose of BeneFIX.|The number of spontaneous, non-traumatic breakthrough bleeds within 48 hours following a prophylaxis dose of BeneFIX were summarized. If there was more than one bleed location (eg, ankle and joint) with identical bleed start date and time, it was treated as one bleed occurrence.|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study. Three participants experienced 1 spontaneous bleeding episode each within 48 hours of a previous prophylaxis infusion.|||Number of breakthrough bleeds|Participants|Standard Deviation|Mean
2688300|NCT01335061|Secondary|Number of Nonacog Alfa, Recombinant Factor IX (BeneFIX) Infusions Used to Treat Each Bleeding Episode.|The number of study drug infusions administered to treat a bleed will be calculated by adding the initial (on-demand) infusion to any subsequent (on-demand) infusions for the same bleed (same bleed start date/time). The number of infusions needed to treat a bleed will be classified into the following categories: 1, 2, 3, 4 and >4 infusions. If there were more than one bleed location (e.g., ankle and joint) with identical bleed start date and time, it was treated as one bleed occurrence.|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study.|||Number of bleeds requiring infusion|Participants||Number
2688301|NCT01335061|Secondary|Response to On-Demand Treatment for All Bleeding Episodes.|Assessment scores on a 4-point Response Scale for an on-demand bleeding episode, as assessed by participant/caregiver or investigator/qualified staff. The 4-point scale assessments are Excellent, Good, Moderate or No response. Responses to number of observations were noted.|2 years|The safety analysis set (SAS) was any participant who received at least one dose of BeneFIX, including the dose given during the enrollment visit (Visit 2) for the factor IX (FIX) recovery study. Follow-up infusion was only required for 18 participants.|||Number of observations with response|Participants||Number
2688302|NCT01335061|Primary|Annualized Number of Bleeding Episodes.|The annualized bleed rate (ABR) or the annualized number of bleeding episodes per year, will be derived for each participant for each treatment period by using the following formula: ABR = number of bleeds / (Days on treatment period / 365.25) The number of bleeds for the ABR calculation includes all bleeds requiring treatment with factor IX product during the time on treatment.|2 years|The efficacy analysis set (EAS) was used for the primary efficacy analyses with respect to ABR. It includes all participants who participated in at least one day of the routine prophylaxis period (ie, in the study through at least Visit 4).|||Number of bleeds per year||Standard Deviation|Mean
2688303|NCT01334957|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.|"Visual Analog Scale (VAS) assessments following surgery. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between o and 100."|6 hours||||units on a scale||95% Confidence Interval|Mean
2688304|NCT01334957|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.|The incidence of treatment-emergent adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen|6 hours||||Number of Adverse Events|||Number
2688305|NCT01334957|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.|The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen|6 hours||||Number of Serious Adverse Events|||Number
2688306|NCT01334957|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Reduction of Post-operative Pain.|The incidence of treatment-emergent adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen|6 hours||||Number of Adverse Events|||Number
2688307|NCT01334957|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Over 5-10 Minutes for the Reduction of Pain.|The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the first dose of intravenous ibuprofen|6 hours||||Number of Serious Adverse Events|||Number
2688308|NCT01334944|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain|The incidence of treatment-emergent adverse events occurring through extended dosing.|24 hours||||Number of Events|||Number
2688309|NCT01334944|Secondary|To Determine the Safety of a Multiple Doses of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain|The incidence of treatment-emergent serious adverse events occurring through extended dosing.|24 hours||||Number of Serious Adverse Events|||Number
2688310|NCT01334944|Secondary|To Determine the Efficacy of a Single Dose of 800 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Pain (Mild to Moderate or Moderate to Severe).|"The change in patient self-assessment of pain utilizing the visual analog scale (VAS) from baseline over the 4 hours following intravenous ibuprofen administration. The VAS is a continuous scale compromised of a horizontal line, one hundred millimeters in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between o and 100."|4 hours||||units on a scale||95% Confidence Interval|Mean
2688311|NCT01334944|Secondary|To Determine the Efficacy of a Single Dose of 400 mg Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever|The change in temperature from baseline over the 4 hours following intravenous ibuprofen administration|4 hours||||Degree Fahrenheit||95% Confidence Interval|Mean
2688312|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Diastolic Blood Pressure).|1 hour||||mm Hg||95% Confidence Interval|Mean
2688313|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Systolic Blood Pressure).|1 hour||||mm Hg||95% Confidence Interval|Mean
2688314|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Respiratory Rate).|1 hour||||Breaths Per Minute||95% Confidence Interval|Mean
2688315|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The change from baseline to one hour post administration of intravenous ibuprofen in vital sign assessments (Heart Rate).|1 hour||||Beats Per Minute||95% Confidence Interval|Mean
2688316|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting|The change from baseline to one hour post administration of intravenous ibuprofen in vitals sign assessments (Temperature)|1 hour||||Degree Fahrenheit||95% Confidence Interval|Mean
2688317|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The incidence of treatment-emergent adverse events occurring in the six hours following administration of intravenous ibuprofen.|6 hours|This analysis was conducted on participants treated with a fever or pain indication that received only a single dose of intravenous ibuprofen|||Number of Events|||Number
2688318|NCT01334944|Primary|To Determine the Safety of a Single Dose of Intravenous Ibuprofen Administered Over 5-10 Minutes for the Treatment of Fever or Pain in the Hospital Setting.|The incidence of treatment-emergent serious adverse events occurring in the six hours following administration of the last dose of intravenous ibuprofen|6 hours||||Number of Serious Adverse Events|||Number
2688319|NCT01334918|Secondary|Percentage of Participants With Two or More Ischemic Segments on SPECT, But Less on CT|Using SPECT as the reference standard, the false negative percentage was calculated as the percentage of participants with two or more ischemic segments on SPECT, but less on CT.|Day 1 and Day 2|Full analysis set participants with two or more reversible defects.|||percentage of participants|||Number
2688320|NCT01334918|Secondary|Number of Participants With Fixed Defects|"Using the 17-segment scoring system, a segment scored above 1 (i.e., 2 to 4) and equal at rest and stress was counted as having a fixed defect.~At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set.|||participants|||Number
2688321|NCT01334918|Secondary|Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX)|"The number of reversible defects in the LCX categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.~The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake.~The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set where scans were available.|||participants|||Number
2688344|NCT01334606|Secondary|Glycemic Control as Measured by Fasting Blood Glucose|The measure of glycemic control will be the percent difference in fasting blood glucose (FBG) assessed at the end of Period 1 and Period 2. The average percent difference in FBG between the Nano and Short pen needles, with the Short as a reference, must be shown to be no more than +/- 20% with 95% confidence. General linear models will be used, adjusted for baseline FBG. This outcome measure will be determined for the total subject population as well as for the subset of Lantus users.|3 weeks per pen needle|||||||
2688322|NCT01334918|Secondary|Number of Participants With Reversible Defects in the Right Coronary Artery (RCA)|"The number of reversible defects in the RCA categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.~The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake.~The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set where scans were available.|||participants|||Number
2688323|NCT01334918|Secondary|Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD)|"The number of reversible defects in the LAD categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.~The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake.~The median score from 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of ≥ 2 segments with reversible defects, excluding segment 17."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set where scans were available.|||participants|||Number
2688324|NCT01334918|Secondary|Overall Image Quality of Scans by Modality and Reviewer|Overall image quality was assessed by three independent blinded readers for each modality (single photon emission computed tomography (SPECT) and multidetector computed tomography (MDCT)). Image quality was rated on a 4-point scale as either excellent, good, fair or poor at rest using SPECT and MDCT and under stress using regadenoson SPECT and regadenoson stress computed tomography perfusion (CTP).|Day 1 and Day 2|The number of participants analyzed represents the full analysis set.|||participants|||Number
2688325|NCT01334918|Primary|Number of Participants With Reversible Defects|"The number of reversible defects categorized into absence or presence of ischemia (0-1 versus ≥2), as assessed by the central imaging laboratory for both SPECT and MDCT.~The 17-segment model for standardized myocardial segmentation was used for myocardial perfusion readings for SPECT and MDCT. At rest and stress, each segment was scored on a 0 to 4 scale according to the amount of contrast or radiotracer the myocardium in the segment absorbed:~0: normal perfusion~1: slightly reduced contrast/radiotracer uptake~2: moderately reduced contrast/radiotracer uptake~3: severely reduced contrast/radiotracer uptake~4: absent contrast/radiotracer uptake.~The median score from the 3 blinded readers for each segment was used. If the stress score was ≥ 2 and the rest score was less than the stress score, the segment was counted as having a reversible defect. A participant was classified as ischemic in the presence of 2 or more segments with reversible defects, excluding segment 17."|Day 1 and Day 2|The number of participants analyzed represents the full analysis set, defined as all randomized patients with interpretable SPECT and CTP scans as determined by at least two of the three blinded readers.|||participants|||Number
2688326|NCT01334866|Secondary|Composite Major Adverse Event Rate (Late)|"Characterize the composite major adverse event rate after 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation. The major adverse events will include:~Major hemorrhage/bleeding requiring surgical intervention~Aortic complications~Graft vessel revision (GVR)~Transient ischemic attacks (TIA)~Cerebrovascular accidents (CVA)/stroke~Myocardial infarction (MI)~Death"|After 30 days post-procedure or hospital discharge, whichever is longer through the 6-Month evaluation||||percentage of subjects|||Number
2688327|NCT01334866|Primary|Composite Major Adverse Event Rate (Early)|"During procedure and within 30 days post-procedure or hospital discharge, whichever is longer. The adverse events will include:~Major hemorrhage/bleeding requiring surgical intervention~Aortic complications~Graft vessel revision (GVR)~Transient ischemic attacks (TIA)~Cerebrovascular accidents (CVA)/stroke~Myocardial infarction (MI)~Death"|During procedure (day 1) and within 30 days post-procedure or hospital discharge, whichever is longer (throughout 6 month evaluation)||||percentage of subjects||95% Confidence Interval|Number
2688328|NCT01334866|Primary|Patency of the Index Graft at 6 Months|"For each subject, the endpoint is the percent of stenosis collected on the subject's 6 month angiography form. This will be characterized for each graft using the FitzGibbon scoring system based on the 64-Slice CT Angiography results.~The FitzGibbon Scoring system is as follows:~A:Excellent graft with unimpaired runoff (< 50% stenosis) B:Stenosis reducing caliber of proximal or distal anastomoses or trunk to <50% of the grafted coronary artery.~O:Occluded (100% stenosed)"|6 months post-procedure||||percentage of grafts|Participants||Number
2688329|NCT01334866|Primary|Procedural Success in a MICS Approach|A successful procedure can be defined as a procedures not requiring conversion (sternotomy). This will be characterized by whether the graft procedure can be completed through the minimally invasive thoracotomy without having to convert to a sternotomy in order to complete the grafting.|At time of procedure (day 1)||||percentage of subjects|||Number
2688330|NCT01334866|Primary|Technical Success (Graft Patency) in a MICS Approach|For each subject, the endpoint for technical success (graft patency) in a MICS approach is defined as acceptable flow for graft size for an anastamosis. This will be characterized by the surgeon's assessment/angiography after the graft is complete.|At time of procedure (day 1)||||percentage of grafts|Participants||Number
2688331|NCT01334723|Secondary|BPH-Related Costs for Every 30 Days of 5-ARI Therapy|In this analysis, we evaluated mean BPH-related costs for every 30 days of 5-ARI therapy. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population|||United States dollars per month||Standard Deviation|Mean
2688332|NCT01334723|Secondary|Mean BPH-Related Costs for Participants With an MPR >=80% Versus <80%|In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=80% versus <80%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population|||United States dollars per month||Standard Deviation|Mean
2688333|NCT01334723|Secondary|Mean BPH-Related Costs for Participants With an MPR >=75% Versus <75%|In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=75% versus <75%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population|||United States dollars per month||Standard Deviation|Mean
2688334|NCT01334723|Secondary|Mean BPH-Related Costs for Participants With an MPR >=70% Versus <70%|In this analysis, we evaluated mean BPH-related costs per month for participants with an MPR of >=70% versus <70%. Mean costs were evaluated by month on therapy for BPH-related medical costs (defined as any claim with a primary ICD-9-CM code of 222.2 or 600.xx).|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population|||United States dollars per month||Standard Deviation|Mean
2688335|NCT01334723|Secondary|Mean Length of 5-ARI Therapy|In this analysis, we evaluated the association between 5-ARI length of therapy and risk of acute urinary retention and prostate surgery.|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population|||days||Standard Deviation|Mean
2688336|NCT01334723|Primary|Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 80%|Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 80%.|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population|||participants|||Number
2688337|NCT01334723|Primary|Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 75%|Claims-based definition of AUR and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR and surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 75%.|Up to one year following the first pharmacy claim for 5ARI therapy or medical encounter for AUR or prostate surgery in the 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population|||participants|||Number
2688338|NCT01334723|Primary|Number of Participants With Risk of Acute Urinary Retention and Surgery Based on an MPR Threshold of 70%|Claims-based definition of acute urinary retention (AUR) and surgery based on the presence of an ICD-9-CM code of 599.6x, 788.20, or 788.29 and CPT procedure codes, respectively. For this analysis, we evaluated the association between compliance with 5-ARI therapy (measured by medication possession ratio [MPR]) and risk of AUR or surgery. MPR was calculated as the number of days that 5-ARI therapy was taken divided by the total number of follow-up days. For this analysis, the threshold for compliance was set at MPR = 70%.|The 5 and a half year period from January 1, 2000 to June 30, 2006|Enrolled Population: participants in the IHCIS database with a diagnosis of benign prostate hyperplasia or enlarged prostate as indicated by ICD-9-CM code on claims (222.2x or 600.xx). Participants were included if they had at least 60 days of 5-ARI therapy during the enrollment period, 6 months of continuous enrollment, and no prior surgery.|||participants|||Number
2688339|NCT01334710|Secondary|Toxicity Assessment|Evaluate the proportion of participants treated with OSI-906 and sorafenib who develop serious adverse events.|28 days from study entry||||Participants|||Count of Participants
2688340|NCT01334710|Primary|Comparison of MRI/CT Scans to Pre-treatment Scan|Efficacy will be measured by evaluating the number of patients who do not have disease progression (measured by CT or MRI scan) 5 months after starting treatment. Assessment of the endpoint of disease progression will be performed every 2 months using either CT or MRI scan. Participants will remain on the study until either evidence of disease progression or unacceptable side effects develop. This period is expected to be on the average 6 months long.|6 months|Trial was terminated early.||||||
2688341|NCT01334606|Secondary|User Acceptability|"After using each pen needle for three weeks, subjects will be asked to respond Yes or No to the question Were the pen needles used for long acting insulin injections at doses greater than 40 units during this past study period acceptable to you? This outcome measure will be determined for the total subject population as well as for the subset of Lantus users."|End of Period 1 (three weeks) and Period 2 (six weeks)|||||||
2688342|NCT01334606|Secondary|Relative Injection Pain|"Subjects will complete a 150 mm Visual Analog Scale (VAS). The VAS is a measure of the pain perceived with the needle they are using at that point in the study relative to the needle they used the previous period. The VAS is anchored at the center (0mm) with as painful and at each extreme with much less painful (-75mm) and much more painful (+75mm). The sign of each VAS score will be adjusted for the order of pen needle (PN) use, such that the 8mm short PN is always considered the reference."|End of Period 2 (six weeks)|||||||
2688343|NCT01334606|Secondary|Percentage of Subjects With at Least One Leakage Event|Leakage will be assessed by the subject after any injections of long-acting insulin of greater than 40 units. Subjects will record in their study diary if they observed insulin leakage from the injection site.|3 weeks per pen needle|||||||
2688363|NCT01333956|Secondary|Neuropathic Pain|Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months). Scale of 0 to 24. Higher values represent worse outcomes.|3 months||||units on a scale||Inter-Quartile Range|Median
2688345|NCT01334606|Primary|Glycemic Control as Measured by Percent (%) Absolute Change in Fructosamine|The measure of glycemic control will be the percent difference in FRU assessed at the end of Period 1 compared to FRU assessed at the end of Period 2. The average percent difference in FRU between the Nano and Short pen needles, with the Short as a reference, must be shown to be no more than +/- 20% with 95% confidence. General linear models will be used, adjusting for baseline FRU. This outcome measure was to be determined for the total subject population as well as for the subset of Lantus users.|3 weeks per pen needle|No analysis was performed. The study was terminated due to slow enrollment. The same endpoint was studied and reported in a similar subject population, including Lantus users, in study DBC-11-SQUIR05(NCT01231984)which had a similar design.||||||
2688346|NCT01334554|Secondary|Endothelial Function|Endothelial function was measured with flow mediated dilation, percent change|Difference between FMD at baseline and 4 weeks|We detected problems with the ultrasound images obtained to measure flow mediated dilation and therefore only data in 14 subjects in the sildenafil group and in 16 subjects in the placebo were analyzed.|||percentage of brachial artery diameter|percent change of brachial artery diamet|Standard Deviation|Mean
2688347|NCT01334554|Primary|Insulin Sensitivity|insulin sensitivity as measured by frequently sampled intravenous glucose tolerance test|Insulin sensitivity measured at baseline and 4 weeks after the intervention||||min-1/pmol/mlx10-5||Standard Deviation|Median
2688348|NCT01334515|Secondary|Overall Response Evaluated in This Study Using the New International Criteria Proposed by the Revised Response Evaluation Criteria in Solid Tumors (RECIST)|Number of patients where best overall response is a complete response (CR)-[disappearance of all target lesions and disappearance of any other measureable disease], a very Good Partial Response (VGPR)- [>90% decrease of the disease measurement for CT/MRI lesions, taking as reference the disease measurement done to confirm measurable disease at study entry. Non-target CT/MRI lesions stable to smaller in size], or partial Response (PR)- [>= 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Non-target CT/MRI lesions stable to smaller in size], and maintains the response. It is possible that a subject's response to therapy may not occur until after several months of treatment. In order to prevent bias, the maximum duration of time/treatment over which a subject's response is to be assessed for determination of the best overall response is after the completion of up to 10 courses.|Every two cycles (each cycle lasts 28 days)|Patients will be evaluable for inclusion in the analysis of response if they have an event at any time on the study or if they complete at least 2 cycles of hu14.18-IL2 therapy. Patients who go off-protocol therapy prior to the completion of 2 cycles due to parent/family choice and/or due to toxicity will not be considered evaluable for response.|||participants|||Number
2688349|NCT01334515|Primary|Number of Patients With Unacceptable Dose Limiting Toxicities (DLTs)|Test for tolerability and monitor for the occurrence of too many unacceptable DLTs using a two-stage stopping rule: (Stage 1) Accrue 10 patients. If more than 1 experience at least one unacceptable DLT during the first treatment cycle, the regimen will be considered to have unacceptable toxicity, and accrual will be temporarily closed, to review all relevant data and consider modifying the regimen to improve safety. If 1 or no patients have an unacceptable DLT in the first treatment cycle, then continue. (Stage 2) Accrue 20 more patients. If 7 or more experience at least one unacceptable DLT in the first treatment cycle, temporarily close the study for possible dosing-safety modifications. If 6 or fewer have an unacceptable DLT in the first treatment cycle, it is reasonable to assume that the combination therapy is safe.|Up to 10 courses|This outcome measure evaluates the first 30 patients to enroll and who receive at least one dose of hu14.18-IL2.|||participants|||Number
2688350|NCT01334229|Secondary|Measurement of Apolipoprotein B48 and Apolipoprotein B100 Fractional Catabolic Rates With Stable Isotope During Postprandial Period||6 weeks||||pools/day||Standard Deviation|Mean
2688351|NCT01334229|Secondary|Measurement of Apolipoprotein B48 and Apolipoprotein B100 Pool Sizes With Stable Isotope During Postprandial Period||6 weeks||||mg||Standard Deviation|Mean
2688352|NCT01334229|Secondary|Measurement of Insulin||6 weeks||||pmol/L||Standard Deviation|Mean
2688353|NCT01334229|Secondary|Measurement of Glucose||6 weeks||||mmol/L||Standard Deviation|Mean
2688354|NCT01334229|Secondary|Measurement of Glucagon-like Peptide-1 by ELISA||6 weeks||||pmol/L||Standard Deviation|Mean
2688355|NCT01334229|Primary|Measurement of Apolipoprotein B48 and Apolipoprotein B100 Production Rates With Stable Isotope During Postprandial Period||6 weeks||||mg/kg/day||Standard Deviation|Mean
2688356|NCT01334216|Primary|Parental Smoking Quit Rate|This is the number of participants who quit smoking|one year||||Participants|||Count of Participants
2688357|NCT01334125|Secondary|Number of Participants With Minor, Major, and Nocturnal Hypoglycemia|Comparison of the occurrence of hypoglycemic event requiring a third party assistance (major hypoglycemia) per subject during the study, and minor hypoglycemia (plasma glucose of <60 mg/dL or no measurement), as well as nocturnal hypoglycemia (plasma glucose of ≤60 mg/dL between 11PM and 6AM).|12 months||||participants|||Number
2688358|NCT01334125|Secondary|Baseline Adjusted Changes in Adiponectin/Leptin Ratio Over Time|Comparison of the baseline-adjusted differences in adiponectin/leptin ratio over time between the metformin and the placebo groups. The reported values represented mean adjusted for baseline values, age, gender, and BMI using repeated measures ANOVA (General Linear Model).|Baseline, 3mo, 6 mo, and 9 months||||ratio||95% Confidence Interval|Mean
2688359|NCT01334125|Secondary|Baseline Adjusted Changes in Lipid Profile Over Time|Comparison of the baseline-adjusted differences in total cholesterol/high density cholesterol index over time between the metformin and the placebo groups. The reported values represented means adjusted for baseline values, age, gender, and BMI using repeated measures ANOVA (General Linear Model).|Baseline, 3mo, 6mo, and 9 months||||ratio||95% Confidence Interval|Mean
2688360|NCT01334125|Primary|Baseline Adjusted Hemoglobin A1c Over Time|Comparison of the baseline-adjusted differences in HbA1c between the metformin and placebo groups during the trial. Hemoglobin A1c is a marker of glycemic control. The reported values represented means adjusted for baseline values, age, gender, and BMI using repeated measures ANOVA (General Linear Model).|Baseline, 3mo, 6mo, and 9 months||||percentage of HbA1c||95% Confidence Interval|Mean
2688361|NCT01333956|Secondary|Satisfaction|Satisfaction with pain management (1-10 scale; 1 = very dissatisfied, 10 = very satisfied)|2 weeks||||units on a scale||Inter-Quartile Range|Median
2688362|NCT01333956|Secondary|Opioid Usage|Opioid Usage (POD1, POD 3, 2 weeks, 3 months)|3 months||||mg||95% Confidence Interval|Mean
2688364|NCT01333956|Secondary|Numeric Rating Scale (NRS)|NRS Pain (pre-operative, POD1, POD3, 2 weeks, 3 months, at orthopedic visits). Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months)|3 months||||units on a scale||95% Confidence Interval|Mean
2688365|NCT01333956|Secondary|Self-assessed Sedation and Confusion|Self-assessed sedation and confusion (POD1). Confusion Assessment Method (CAM score) (pre-operative and on POD1)|1 day postoperatively||||percentage of patients|||Number
2688366|NCT01333956|Secondary|Opioid-Related Symptom Distress Score|Opioid-Related Symptom Distress score (ORSDS) measured at POD1 and POD14. The ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 12 symptom-specific scores. (0=low; 4=high).|2 weeks postoperatively||||units on a scale||Inter-Quartile Range|Median
2688367|NCT01333956|Primary|Postoperative Pain|Pain assessment scale (Numeric Rating Scale) (0=no pain; 10=worst pain imaginable).|2 weeks postoperatively||||units on a scale||Standard Deviation|Mean
2688368|NCT01333943|Secondary|Total Length of Hospital Stay||Total length of hospital stay||||days||Standard Deviation|Mean
2688369|NCT01333943|Secondary|Incidence of Postoperative Complications.||Postoperative day 4.||||Participants|||Count of Participants
2688370|NCT01333943|Secondary|Patient Satisfaction With the Nerve Block.|Patient satisfaction was measured on a 0-10 scale (0=not satisfied; 10=very satisfied).|24 hours following administration of anesthesia.|One patient was excluded from analysis, and the remaining 93 patients were included.|||units on a scale||Standard Deviation|Mean
2688371|NCT01333943|Secondary|NRS Pain Scores at Rest|Patients rated pain on a scale of 0-10, with 0 representing no pain and 10 representing worst pain.|Postoperative day 4.|One patient was excluded at the time of analysis, and the remaining 93 patients were included in the analysis.|||units on a scale||Standard Deviation|Mean
2688372|NCT01333943|Secondary|Total Opioid Usage|Opioid consumption data were collected and converted to oral morphine equivalents.|Postoperative day 4.|One patient was excluded from analysis due to a condition. Data from the remaining 93 patients were analyzed.|||mg||Standard Deviation|Mean
2688373|NCT01333943|Primary|Quadriceps Muscle Strength|Measurements were made by a handheld dynamometer while patients perform isometric exercises. Results are presented in kilogram-force (kgF) units. One kgF is equal to 9.80665 N.|48 hours following administration of anesthesia.||||kilogram-force||Standard Deviation|Mean
2688374|NCT01333865|Secondary|Number of Participants With Reduction in ASD Symptom Severity as Defined by the NIMH Clinical Global Impression for Pervasive Developmental Disorders (CGI-PDD) Improvement Score|Number of participants with reduction in ASD symptom severity defined as an NIMH Clinical Global Impression (CGI) Pervasive Developmental Disorder (PDD) Improvement score less than or equal to 2. The CGI-Improvement is a clinician-rated measure of improvement. Scores range from 1 (very much improved) to 7 (very much worse) for PDD.|Pre-treatment - 12 weeks|19 participants were exposed to the medication, but 1 withdrew due to feeling mildly sedated which affected his driving. This occurred too early in the study for him to be analyzed.|||participants|||Number
2688375|NCT01333865|Primary|Number of Participants With Reduction in ASD Symptom Severity as Defined by the Social Responsiveness Scale (SRS)|"Number of participants with reduction in ASD symptom severity defined as a reduction in Social Responsiveness Scale (SRS) score from baseline of greater than or equal to 30%.~The SRS is a 65-item rating scale completed by an informant to measure the severity of autism spectrum symptoms as they occur in natural settings."|Week 12|19 participants were exposed to the medication, but 1 withdrew due to feeling mildly sedated which affected his driving. This occurred too early in the study for him to be analyzed.|||participants|||Number
2688376|NCT01333813|Secondary|Number of Subjects Reporting Any Serious Adverse Events (SAEs)|SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.|After the challenge dose of Engerix-B Kinder vaccine up to the study end (Day 0 to Month 1)|Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine.|||Participants|||Count of Participants
2688377|NCT01333813|Secondary|Number of Subjects Reporting Any Unsolicited AEs|Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.|During the 31-day (Day 0-30) follow-up period after the challenge dose of Engerix-B Kinder vaccine|Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine.|||Participants|||Count of Participants
2688378|NCT01333813|Secondary|Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs|"Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and temeperature.~Any temperature was defined as axillary temperature ≥ 37.5 degree centigrade (°C), grade 3 temperature was axillary temperature > 39.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination."|During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine|Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine.|||Participants|||Count of Participants
2688379|NCT01333813|Secondary|Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)|Solicited local symptoms assessed were pain, redness and swelling. Any was occurrence of any local symptom regardless of their intensity grade. Grade 3 pain was considerable pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was > 50 millimeter (mm).|During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-B Kinder vaccine|Analysis was performed on Total Vaccinated cohort which included all subjects who received the challenge dose of Engerix-B Kinder vaccine .|||Participants|||Count of Participants
2693462|NCT01294748|Primary|Major Adverse Cardiac Events (MACE)|Defined as death, MI (Qwave and non-Q-wave) and TVR at 9 months post-procedure. Assessed on all patients with adequate follow-up at 270 days.|9 months||||percentage of participants|||Number
2688380|NCT01333813|Secondary|Number of Subjects Demonstrating an Anamnestic Response to the Engerix-B Kinder Challenge Dose|The anamnestic response is defined as an antibody concentration ≥ 10 mIU/mL at post Engerix-B Kinder challenge dose time point for initially seronegative subjects ,and as an antibody concentration at post Engerix-B Kinder challenge dose time point ≥ 4 fold the pre-vaccination antibody concentration for initially seropositive subjects. A seropositive/seronegative subject was defined as subject with HBs antibody concentration below/greater than or equal to the seropositivity cut-off of 6.2 mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|After Engerix-B Kinder challenge dose (Month 1)|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.|||Participants|||Count of Participants
2688381|NCT01333813|Secondary|Anti-HBs Antibody Concentrations|Antibody concentrations are expressed as Geometric mean antibody concentrations (GMCs) in mIU/mL. A decrease in the specificity of the anti-HBs had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.|||mIU/mL||95% Confidence Interval|Geometric Mean
2688382|NCT01333813|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above Protocol Specified Cut-off Values|Anti-HBs antibody concentrations cut-off values assessed were ≥ 6.2 mIU/mL (previously 3.3 mIU/mL) and ≥ 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.|||Participants|||Count of Participants
2688383|NCT01333813|Secondary|Number of Subjects With Anti-HBs Antibody Concentrations Equal to or Above the Protocol Specified Cut-off Values After Previous Vaccination With Infanrix Hexa Vaccine|Anti-HBs antibody concentrations cut-off values assessed were ≥ 6.2 mIU/mL (previously 3.3 mIU/mL), ≥ 10 mIU/mL, ≥ 10 mIU/mL to <100 mIU/mL and ≥ 100 mIU/mL. A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis and the initial 3.3 mIU/mL seropositivity cut-off was revised into the new 6.2 mIU/mL cut-off.|Before (Day 0) a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all subjects previously primed and boosted with 4 doses of Infanrix hexa in the first 2 years of life; with no evidence of hepatitis B infection or disease and for whom serological results were available at the pre- Engerix-B Kinder challenge time point.|||Participants|||Count of Participants
2688384|NCT01333813|Secondary|Anti-HBs Antibody Concentrations After Previous Vaccination With Infanrix Hexa Vaccine.|"Antibody concentrations are expressed as Geometric mean antibody concentrations (GMCs) in mIU/mL.~A decrease in the specificity of the anti-HBs ELISA had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis."|Before (Day 0) a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for persistence which included all subjects previously primed and boosted with 4 doses of Infanrix hexa in the first 2 years of life; with no evidence of hepatitis B infection or disease and for whom serological results were available at the pre- Engerix-B Kinder challenge time point.|||mIU/mL||95% Confidence Interval|Geometric Mean
2688385|NCT01333813|Primary|Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL)|A decrease in the specificity of the anti-HBs enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of anti-HBs antibodies (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi-Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.|One month (Month 1) after a challenge dose of Engerix-B Kinder vaccine|Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who had received a challenge dose of Engerix-B Kinder vaccine and for whom immunogenicity data were available at the post- Engerix-B Kinder challenge time point.|||Participants|||Count of Participants
2688386|NCT01333722|Secondary|Time to Perceptible and Meaningful Pain Relief|The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.|||minutes||95% Confidence Interval|Median
2688429|NCT01333397|Secondary|Percentage of Subjects as Responders at Maximum Frown on Day 29 Who Remain Responders|A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2.|Day 113|ITT Population; N’=number of responders at Day 29|||percentage of subjects|||Number
2688387|NCT01333722|Secondary|SPRID (Pain Relief and Pain Intensity Difference)|"SPRID was defined as the sum of Pain Relief score (TOTPAR, See Outcome Measure 2 for details*) plus the Pain Intensity Difference (SPID) Categorical score, where participants assessed pain intensity on a Categorical Pain Intensity Scale by answering the following question: My pain at this time is… with one of the following responses: no pain or none, mild pain, moderate pain, or severe pain). Higher mean SPRID scores indicated better pain control. The SPRID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule."|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.|||scores on a scale||Standard Error|Least Squares Mean
2688388|NCT01333722|Secondary|TOTPAR (Total Pain Relief)|TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants' responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.|||scores on a scale||Standard Error|Least Squares Mean
2688389|NCT01333722|Primary|Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analog Scale (VAS)|"Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning no pain and 100 meaning the worst pain imaginable. The SPID VAS score for 0 to 12 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule."|From time of first study drug administration to 12 hours following first study drug administration|All randomized participants who received at least 1 dose of study drug.|||scores on a scale||Standard Error|Least Squares Mean
2688390|NCT01333592|Primary|Incidences of Adverse Events||52 weeks||||Participants|||Number
2688391|NCT01333592|Secondary|Change From Baseline in HbA1c at 52 Weeks||at week 0 and week 52||||percentage of HbA1c||Standard Deviation|Mean
2688392|NCT01333501|Secondary|Changes in the Environmental Status Scale Score (ESS)|The Environmental Status Scale (ESS) is used to quickly evaluate a patient for handicap. It was derived from a measure of socio-economic status. It consists of seven parameters: (1) actual work status, (2) financial and economic status, (3) personal residence or home, (4) personal assistance required, (5) transportation, (6) community services, (7) social activity. Each parameter has a single score from minimum 0 to maximum 5. ESS score is the sum of the points for all 7 parameters: minimum score: 0; maximum score: 35. The higher the score the greater the handicap|Baseline, 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Score||Standard Deviation|Mean
2688393|NCT01333501|Secondary|Change From Screening in the Percentage of Brain Volume Change|Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||percentage of brain volume||Standard Deviation|Mean
2688394|NCT01333501|Secondary|Change From Screening in the Number of T1 Gd+ Enhancing Lesions|Total number of post-baseline Gd-enhanced lesions is calculated as a sum of all Gd-enhanced lesions seen on post-baseline scans per visit. Real (not per slice) lesions are counted in this analysis|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Number of new lesions||Standard Deviation|Mean
2688395|NCT01333501|Secondary|Change From Screening in the Volume of Total T1 Hypointense Lesions|Volume of hypointense post-gadolinium T1 lesion component was measured by MRI scan. Means were estimated using a Mixed-effect model with repeated measures (MMRM) by-visit interaction.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||mm^3||Standard Deviation|Mean
2688396|NCT01333501|Secondary|Change From Screening in the Number of New T2 Lesions|New T2 lesions at a specific visit were assessed relative to the previous visit scan. The total number of lesions (visit 8 to 18 month) is calculated as the sum of the number of lesions.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Number of new lesions||Standard Deviation|Mean
2688397|NCT01333501|Secondary|Changes From Baseline in Fatigue Impact Scale (mFIS, Total Score and Scores of the 3 Individual Domains).|Modified Fatigue Impact Scale (mFIS) questionnaire is described at each time point to evaluate fatigue by means of usual descriptive statistics. Three domains were also defined: Physical Subscale (sum of items 4, 6, 7, 10, 13, 14, 17, 20, 21 and therefore ranging from 0 to 36), Cognitive Subscale (sum of items 1, 2, 3, 5, 11, 12, 15, 16, 18, 19 and therefore ranging from 0 to 40) and Psychosocial Subscale (sum of items 8, 9 and therefore ranging from 0 to 8). Finally, mFIS - overall score ranged from 0 to 80. The mFIS total score was computed as the sum of scores for each item. Lower values represent a better outcome.|Baseline, 18 months|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Score||Standard Error|Least Squares Mean
2688398|NCT01333501|Secondary|Changes in Quality of Life, by Means of the Multiple Sclerosis Quality of Life (MSQoL-54)|A 54 question measure covers 12 domains; assesses mental and physical health. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress. Each domain has a range from 0 to 100 where higher means better.|Baseline, 18 months|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Score||Standard Error|Least Squares Mean
2688399|NCT01333501|Secondary|Change From Screening in Montgomery-Asberg Depression Rating Scale (MADRS)|MADRS measures the overall severity of depressive symptoms. The MADRS had a 10-item checklist. Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
2688400|NCT01333501|Secondary|Change From Screening in the Volume of Total T2 Lesions|Change in volume of total T2-weighted lesions by visit were summarized. Negative values indicate improvement (reduction in lesion volume) and positive values worsening (increase in lesion volume|Screening (-1 month), 18 months||||mm^3||Standard Deviation|Mean
2688401|NCT01333501|Primary|Change From Screening in DKEFS Condition 2: Sort Recognition, Sort Recognition Description Score- Card Set 1+2|The Delis-Kaplan Executive Function System - Sorting Test is one of the nine tests presented in the DKEFS manual and explores the patient's executive abilities. It has a standard form (version A, administered at screening and Month-18 visit) and an alternate form (version B, administered at Month-9 visit). The standard form consists of the practice card set, card set 1 and card set 2. The alternate form consists of the same practice card set, card set 3 and card set 4. Free sorting and sort recognition. In free sorting, six scores were obtained: Confirmed Correct sorts for card sets 1 and 2 (or 3 and 4 for version B), sum of confirmed Correct Sorts, Free Sorting Description score for card set 1 and 2 (or 3 and 4 for version B) and sum of Free Sorting Description scores. The total score ranged from 0 to 64. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
2688402|NCT01333501|Primary|Change From Screening in DKEFS Condition 1: Free Sorting, Free Sorting, Description Score, Card Set 1+2|The Delis-Kaplan Executive Function System - Sorting Test is one of the nine tests presented in the DKEFS manual and explores the patient's executive abilities. It has a standard form (version A, administered at screening and Month-18 visit) and an alternate form (version B, administered at Month-9 visit). The standard form consists of the practice card set, card set 1 and card set 2. The alternate form consists of the same practice card set, card set 3 and card set 4. In free sorting, six scores were obtained: Confirmed Correct sorts for card sets 1 and 2 (or 3 and 4 for version B), sum of confirmed Correct Sorts, Free Sorting Description score for card set 1 and 2 (or 3 and 4 for version B) and sum of Free Sorting Description scores. In sort recognition, a description score for card set 1 and 2 (or 3 and 4 for version B) was obtained, as well as the sum of description scores of both sets. The total score ranged from 0 to 64. Higher values represent a better outcome|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
2688403|NCT01333501|Primary|Change From Screening in Delis-Kaplan Executive Function System (DKEFS) Condition 1: Free Sorting, Confirmed Correct Sort- Card Set 1+2|The Delis-Kaplan Executive Function System - Sorting Test is one of the nine tests presented in the DKEFS manual and explores the patient's executive abilities. It has a standard form (version A, administered at screening and Month-18 visit) and an alternate form (version B, administered at Month-9 visit). The standard form consists of the practice card set, card set 1 and card set 2. The alternate form consists of the same practice card set, card set 3 and card set 4. The DKFES test consisted of two testing procedures: free sorting and sort recognition. In free sorting, six scores were obtained: Confirmed Correct sorts for card sets 1 and 2 (or 3 and 4 for version B), sum of confirmed Correct Sorts. In sort recognition, a description score for card set 1 and 2 (or 3 and 4 for version B) was obtained, as well as the sum of description scores of both sets. The total score ranged from 0 to 16. Higher values represent a better outcome|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
2688404|NCT01333501|Primary|Change From Screening in Word List Generation (WLG)|Word List Generation (COWAT/WLG): The COWAT assesses verbal fluency on semantic stimulus by asking the patient to produce as many words as possible belonging to a semantic category. The test assessed the verbal fluency, recorded all the possible correct word that a patients should give in 90 sec. No maximum range is available. Higher values represent a better outcome. The score was the number of correct words. The more words the patient pronounces, the better it is. We can imagine that the minimum value might be zero words, , but it is not a score scale.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
2688443|NCT01333189|Secondary|Walking Speed|Self-selected walking speed was recorded for three passes across the middle 6 meter section of a walkway. The average of the 3 passes is reported.|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.|||meters/second||Standard Deviation|Mean
2688405|NCT01333501|Primary|Change From Screening in Spatial Recall Test - Delayed Recall (SPART-D)|Spatial Recall Test (SPART) for visuospatial learning and delayed recall.Spatial Recall Test (10/36): The spatial recall test assesses visuospatial learning and delayed recall (10/36-D). A checkerboard with ten checkers arranged in a pattern was shown to the subject for ten seconds. The subject was then asked to reproduce the same pattern with ten checkers on an empty checkerboard. The test includes three consecutive trials. The score was the total number of correct responses for the tree trials. The total score ranged from 0 to 10. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
2688406|NCT01333501|Primary|Change From Screening in Selective Reminding Test - Delayed Recall (SRT-D) Raw Score|The tests SRT (Selective Reminding Test) for episodic memory (verbal learning and delayed recall). The Delayed SRT test is the total number of words recalled after a delayed period. The total score ranged from 0 to 12. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
2688407|NCT01333501|Primary|Change From Screening in Paced Auditory Serial Addition Test - 2 (PASAT 2) Raw Score|Paced Auditory Serial Addition Test (PASAT) for working memory (and sustained attention and information processing speed). The patient hears a series of numbers from recordings that are presented at the rate of one every 2 seconds in the second part of the test (PASAT-2). The patient was asked to add each consecutive digit to the one immediately preceding it. Sixty-one digits are presented for each part, and each part has a maximum of 60 correct answers. The total score ranged from 0 to 60. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
2688408|NCT01333501|Primary|Change From Screening in Paced Auditory Serial Addition Test - 3 Seconds (PASAT 3) Raw Score|Paced Auditory Serial Addition Test (PASAT) for working memory (and sustained attention and information processing speed). The patient hears a series of numbers from recordings that are presented at the rate of one every 3 seconds in the first part of the test (PASAT-3). The patient is asked to add each consecutive digit to the one immediately preceding it. Sixty-one digits are presented for each part, and each part has a maximum of 60 correct answers. The total score ranged from 0 to 60. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
2688409|NCT01333501|Primary|Change From Screening in Symbol Digit Modalities Test (SDMT) Raw Score|Symbol Digit Modality Test (SDMT) for sustained attention and information processing speed. It presents a series of nine symbols, each of which is paired with a single digit labeled 1-9 in a key at the top of the sheet. The reminder of the page has a pseudo-randomized sequence of symbols, and the patient must respond with the digit associated with each of these as quickly as possible. The score is the number of correct answers in 90 seconds. The total score ranged from 0 to 110. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
2688410|NCT01333501|Primary|Change From Screening in Spatial Recall Test (SPART) Raw Score|Spatial Recall Test (SPART) for visuospatial learning and delayed recall.Spatial Recall Test (10/36): The spatial recall test assesses visuospatial learning and delayed recall (10/36-D). A checkerboard with ten checkers arranged in a pattern is shown to the subject for ten seconds. The subject is then asked to reproduce the same pattern with ten checkers on an empty checkerboard. The test includes three consecutive trials. The score is the total number of correct responses for the tree trials. The total score ranged from 0 to 30. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations|||Raw score||Standard Error|Least Squares Mean
2688411|NCT01333501|Primary|Change From Screening in Selective Reminding Test - Consistent Long Term Retrieval (SRT-CLTR) Raw Score|Brief Repeatable Battery (BRB)- widely used as a clinical and research tool, with 68% sensitivity and 85% specificity. It consists of the serial administration of 5 tests. One of the tests is SRT (Selective Reminding Test) for episodic memory (verbal learning and delayed recall). A word recalled on two consecutive trials is considered to have entered long-term storage (LTS) on the first of these trials and scored as LTS on all following trials. The total of the words in LTS of all six trials is then summed. If a word in LTS is consistently recalled on all subsequent trials, it is then scored as Consistent Long Term Retrieval (CLTR). The total of the words in CLTR of all six trials is summed. The total score ranged from 0 to 72. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations.|||Raw score||Standard Error|Least Squares Mean
2688428|NCT01333397|Secondary|Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Investigator's Live Assessment|A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/none or from Visit 2 severity of moderate to none after treatment as measured by the Investigator's live assessment|Days 8, 15, 29, 57, 85 and 113|ITT Population; N’= number of subjects with an Investigator's live assessment of glabellar lines at maximum frown for the given post-Baseline visit|||percentage of subjects|||Number
2688412|NCT01333501|Primary|Change From Screening in Selective Reminding Test - Long-Term Storage (SRT-LTS) Raw Score|Brief Repeatable Battery (BRB)- widely used as a clinical and research tool, with 68% sensitivity and 85% specificity. It consists of the serial administration of 5 tests. One of the tests is SRT (Selective Reminding Test) for episodic memory (verbal learning and delayed recall). A word recalled on two consecutive trials is considered to have entered long-term storage (LTS) on the first of these trials and scored as LTS on all following trials. The total of the words in LTS of all six trials is then summed. The total score ranged from 0 to 72. Higher values represent a better outcome.|Screening (-1month), 18 month|Full analysis set (FAS) - all randomized patients who received at least one dose of study drug and had at least one post-baseline assessment of both primary efficacy variables (i.e. non-missing information about the BRB and DKEFS – Sorting test) without any major protocol violations.|||raw score||Standard Error|Least Squares Mean
2688413|NCT01333488|Secondary|Vasospasm|as measured by TCD (Transcranial Doppler)|up to 3 months||||Percentage of participants|||Number
2688414|NCT01333488|Secondary|GOS|GOS score|12 months after injury||||GOS score||Full Range|Mean
2688415|NCT01333488|Primary|GOS (Glasgow Outcome Score)|"GOS=5 (Good Recovery) - Capacity to resume normal occupational and social activities, although some there may be some minor physical or mental deficits or symptoms.~GOS=4 (Moderate Disability) - Independent and can resume almost all activities of daily living.~GOS=3 (Severe Disability) - No longer capable of engaging in most previous personal, social or work activities. Typically are partially or totally dependent on assistance from others in daily living.~GOS=2 ( Persistent Vegetative State ) GOS=1 (Dead)"|Discharge from Hospital - Within 2 months from Injury||||units on a scale||Full Range|Mean
2688416|NCT01333475|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|29 months, 23 days||||participants|||Number
2688417|NCT01333475|Primary|pERK and pAKT Levels in Tumor Biopsies on C1D1 and C1D22 Post-administration of the Combination of AZD6244 Hydrogen Sulfate and MK-2206 in Participants With Advanced Colorectal Cancer|A predetermined target inhibition reduction of 70% of both pERK and pAKT was deemed significant, thus tumor biopsies were performed at C1D1 or C1D22 post administration and evaluated using quantitative chemiluminescence immunoassay to measure pERK and pAKT levels in human tissue.|C1D1 and C1D22 post administration of the combination of AZD6244 hydrogen sulfate and MK-2206||||pg/ µg of protein||Full Range|Mean
2688418|NCT01333436|Secondary|Fasting ApoB-48 Levels|ApoB-48 levels measured after at least a 12-hour fast and prior to administration of test meal (Hour 0).|Baseline (Hour 0)|Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC.|||μg/mL||Standard Deviation|Mean
2688419|NCT01333436|Secondary|Postprandial Mean ApoB-48 Peak Levels|ApoB-48 levels measured at 1, 2, 3, 4, and 6 hours after the administration of test meal. Peak was the highest ApoB-48 level recorded during this timeframe.|up to 6 hours after Test Meal|Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC.|||μg/mL||Standard Deviation|Mean
2688420|NCT01333436|Primary|Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48)|ApoB-48 levels were measured at 1, 2, 3, 4, and 6 hours after the administration of the test meal.|up to 6 hours after Test Meal|Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC.|||μg/mL x h||Standard Deviation|Mean
2688421|NCT01333397|Secondary|Percentage of Subjects as Responders at Day 29 by the Investigator's Live Assessment and by Subject's Self Assessment of Glabellar Lines at Maximum Frown (Assay Sensitivity)||Day 29|ITT Population; N’=number of subjects with an assessment at Day 29|||percentage of subjects|||Number
2688422|NCT01333397|Secondary|Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Rest (Comparison With Dysport 50 U)||Days 8, 15, 29, 57, 85 and 113|ITT Population; N’=number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit|||percentage of subjects|||Number
2688423|NCT01333397|Secondary|Percentage of Subjects as Responders, as Measured by the Subject's Self Assessment at Maximum Frown (Comparison With Dysport 50 U)||Days 8, 15, 29, 57, 85 and 113|ITT Population; N’=number of subjects with assessment|||percentage of subjects|||Number
2688424|NCT01333397|Secondary|Percentage of Subjects as Responders, as Measured by the Investigator's Live Assessment at Maximum Frown (Comparison With Dysport 50 U)||Days 8, 15, 29, 57, 85 and 113|ITT Population; N’=number of subjects with assessment|||percentage of subjects|||Number
2688425|NCT01333397|Other Pre-specified|Number of Subjects Reporting at Least One Treatment Emergent Adverse Event During the Study|Treatment Emergent Adverse Event (TEAE)|Up to Day 113 (±3 days)|Safety Population: The safety population included all randomised subjects who received study treatment, regardless of the actual amount injected|||participants|||Number
2688426|NCT01333397|Secondary|Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Maximum Frown as Measured by the Subject's Self-assessment|A reduction of two or more grades in the severity of glabellar lines at maximum frown was a change from Visit 2 severity of glabellar lines from severe to mild/no wrinkles or from Visit 2 severity of moderate to no wrinkles after treatment as measured by the subjects self assessment.|Days 8, 15, 29, 57, 85 and 113|ITT Population; N’= number of subjects with a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit|||percentage of subjects|||Number
2688427|NCT01333397|Secondary|Percentage of Subjects With a Reduction of Two or More Grades in the Severity of Glabellar Lines at Rest as Measured by the Investigator's Live Assessment|A reduction of two or more grades in the severity of glabellar lines at rest was a change from Visit 2 severity of glabellar lines from severe to mild or from Visit 2 severity of moderate to none after treatment as measured by the Investigator's live assessment.|Days 8, 15, 29, 57, 85 and 113|ITT Population; N’= number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit|||percentage of subjects|||Number
2689860|NCT01323517|Secondary|Toxicity of Additional Ipilimumab Will be Evaluated for All Treated Patients Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0||2 years||||Participants|||Count of Participants
2688430|NCT01333397|Secondary|Percentage of Subjects as Responders at Rest as Measured by the Investigator's Live Assessment.|A responder at rest was defined as a subject having a severity grade of none or mild at rest on the visit day and a severity grade of moderate or severe at rest at Visit 2.|Days 8, 15, 29, 57, 85 and 113|ITT Population; N’= number of subjects with an Investigator's live assessment of glabellar lines at rest of moderate or severe at Baseline and with an assessment at the given post-Baseline visit;|||percentage of subjects|||Number
2688431|NCT01333397|Secondary|Percentage of Subjects Assessed as Responders, by Both the Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.||Days 8, 15, 57, 85 and 113|ITT Population; N’= number of subjects with an Investigator's live assessment and a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit|||percentage of subjects|||Number
2688432|NCT01333397|Secondary|Percentage of Subjects as Responders at Maximum Frown as Measured by the Subject's Self-assessment.||Days 8, 15, 57, 85 and 113|ITT Population; N’= number of subjects with a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit|||percentage of subjects|||Number
2688433|NCT01333397|Secondary|Percentage of Subjects as Responders at Maximum Frown as Measured by the Investigator's Live Assessment.||Days 8, 15, 57, 85 and 113|ITT Population; N’=number of subjects with an Investigator's live assessment of glabellar lines at maximum frown for the given post-Baseline visit|||percentage of subjects|||Number
2688434|NCT01333397|Secondary|Percentage of Subjects as Assessed as Responders, by Both Investigator's Live Assessment and the Subject's Self-assessment at Maximum Frown.|A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on the visit day and a severity grade of moderate or severe at maximum frown at Visit 2.|Day 29|ITT Population; Day 29 (N'=34,36,35,33,35); N’= number of subjects with an Investigator's live assessment and a subject's self assessment of glabellar lines at maximum frown for the given post-Baseline visit|||percentage of subjects|||Number
2688435|NCT01333397|Primary|Percentage of Subjects as Responders in the ILA (Using Validated 4-point Photographic Scale) and the SSA of Glabellar Lines at Maximum Frown|"Investigator's live assessment (ILA), subject's self assessment (SSA), Next Generation (NG)~4-point photographic scale: Investigator's live assessment: None - 0; Mild - 1; Moderate - 2; Severe - 3;~4-point photographic scale: Subject's Self assessment: No wrinkles - 0; Mild wrinkles - 1; Moderate wrinkles - 2; Severe wrinkles - 3;~A responder at maximum frown was defined as a subject having a severity grade of none or mild at maximum frown on Day 29 and a severity grade of moderate or severe at maximum frown at Visit 2."|Day 29|Intent-to-Treat Population: The intent-to-treat (ITT) population included all randomised subjects who received study treatment, regardless of the actual amount injected. N’=number of subjects with assessment|||percentage of subjects|||Number
2688436|NCT01333189|Secondary|Hip, Knee, and Ankle Moments During Walking|Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.|||Newton-meters per kilogram (Nm/kg)||Standard Error|Mean
2688437|NCT01333189|Secondary|Walking Speed|Self-selected walking speed was recorded for three passes across the middle 6 meter section of a walkway. The average of the 3 passes is reported.|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.|||meters/second||Standard Deviation|Mean
2688438|NCT01333189|Secondary|Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test|Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.|||Newton-meters per kilogram (Nm/kg)||Standard Deviation|Mean
2688439|NCT01333189|Secondary|Five Times Sit-to-Stand Test (FTSST)|The Five Times Sit-to-Stand Test is quantified as the total time required for an individual to rise from and return to a chair five times in a row.|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.|||seconds||Standard Deviation|Mean
2688440|NCT01333189|Secondary|Weight-bearing Ratio During Walking|Weight-bearing ratio is measured during walking as the ratio between lower limbs in peak vertical ground reaction force (vGRF) during the loading response phase of the stance period of gait. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.|||ratio||Standard Deviation|Mean
2688441|NCT01333189|Secondary|Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST)|Weight-bearing ratio is measured during transitions between sitting and standing and is indicated by symmetry in vertical ground reaction force (vGRF) between lower limbs. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).|26 weeks post-operative|At the long-term follow up time point (26 weeks post-operative), a total of two patients from each group had dropped out of the study due to time constraints, transportation difficulties, late infection, or moving away from the area.|||ratio||Standard Deviation|Mean
2688442|NCT01333189|Secondary|Hip, Knee, and Ankle Joint Moments During Walking|Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.|||Newton-meters per kilogram (Nm/kg)||Standard Deviation|Mean
2688444|NCT01333189|Secondary|Hip, Knee, and Ankle Joint Moments During Five Times Sit-to-Stand Test|Internal joint moments at the hip, knee, and ankle were calculated using an inverse dynamics approach from data collected using embedded force plates and a 6-camera motion analysis system to assess reflective marker positions placed at landmarks of the upper limbs, trunk, and lower limbs.|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.|||Newton-meters per kilogram (Nm/kg)||Standard Deviation|Mean
2688445|NCT01333189|Secondary|Five Times Sit-to-Stand Test (FTSST)|The Five Times Sit-to-Stand Test is quantified as the total time required for an individual to rise from and return to a chair five times in a row.|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.|||seconds||Standard Deviation|Mean
2688446|NCT01333189|Secondary|Weight-bearing Ratio During Walking|Weight-bearing ratio is measured during walking as the ratio between lower limbs in peak vertical ground reaction force (vGRF) during the loading response phase of the stance period of gait. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.|||ratio||Standard Deviation|Mean
2688447|NCT01333189|Primary|Weight-bearing Ratio During Five Times Sit-to-Stand Test (FTSST)|Weight-bearing ratio is measured during transitions between sitting and standing and is indicated by symmetry in vertical ground reaction force (vGRF) between lower limbs. Ratios reported are (vGRF of the Surgical Limb):(vGRF Non-Surgical Limb).|6 weeks post-operative|At the completion of the intervention (6 weeks post-operative), one patient from each group had dropped out of the study due to either time constraints or transportation difficulties.|||ratio||Standard Deviation|Mean
2688448|NCT01333111|Secondary|Host Cell Proteins (HCP) Antibodies|Subjects who were positive for anti-HCP antibodies.|28 weeks after treatment start on on-demand treatment|Safety analysis set included all subjects exposed to nonacog beta pegol. Subjects in on-demand arm were included for this analysis.|||number of subjects|||Number
2688449|NCT01333111|Secondary|Host Cell Proteins (HCP) Antibodies|Subjects who were positive for anti-Host Cell Protein (HCP) antibodies.|52 weeks after treatment start for patients on prophylaxis|Safety analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.|||number of subjects|||Number
2688450|NCT01333111|Secondary|Incidence of Serious Adverse Events (SAEs)|SAE was defined as an AE that resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. The incidence of SAEs were summarised by the rate of SAEs (number of SAEs per PYE). Number of SAEs per PYE is number of SAEs/total time in trial. All SAEs reported are treatment emergent (any serious adverse events which occurred after trial product administration).|at 32 weeks ±2 weeks for patients on on-demand treatment|Safety analysis set included all subjects exposed to nonacog beta pegol. Subjects in on-demand arm were included for this analysis.|||number of SAEs per PYE|||Number
2688451|NCT01333111|Secondary|Incidence of Serious Adverse Events (SAEs)|SAE was defined as an AE that resulted in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. The incidence of SAEs were summarised by the rate of SAEs (number of SAEs per PYE). Number of SAEs per PYE is number of SAEs/total time in trial. All SAEs reported are treatment emergent (any serious adverse events which occurred after trial product administration).|at 56 weeks ±2 weeks for patients on prophylaxis|Safety analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.|||number of SAEs per PYE|||Number
2688452|NCT01333111|Secondary|Incidence of Adverse Events (AEs)|The incidence of adverse events were summarised by the rate of AEs (number of AEs per PYE). Number of adverse events per PYE is number of adverse events /total time in trial. All adverse events reported are treatment emergent (any adverse events which occurred after trial product administration).|at 32 weeks ±2 weeks for patients on on-demand treatment|Safety analysis set included all subjects exposed to nonacog beta pegol.Subjects in on-demand arm were included for this analysis.|||number of AEs per PYE|||Number
2688453|NCT01333111|Secondary|Incidence of Adverse Events (AEs)|The incidence of adverse events were summarised by the rate of AEs (number of AEs per patient years of exposure [PYE]). Number of adverse events per PYE is number of adverse events /total time in trial. All adverse events reported are treatment emergent (any adverse events which occurred after trial product administration).|at 56 weeks ±2 weeks for patients on prophylaxis|Safety analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.|||number of AEs per PYE|||Number
2688454|NCT01333111|Secondary|Factor IX Trough Levels|The mean pre-dose factor IX levels was measured with the one-stage clotting assay during the trial. Lowest factor IX activity recorded during single-dose and steady state, immediately before next dose was given. The analysis was based on a mixed model on the log-transformed plasma factor IX activity with subject as a random effect. The estimated mean factor IX trough level was presented back-transformed to the natural scale.|52 weeks after treatment start for patients on prophylaxis|Full analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.|||U/mL||95% Confidence Interval|Mean
2688455|NCT01333111|Secondary|Number of Bleeding Episodes Per Patient During Routine Prophylaxis|The number of bleeding episodes per patient during routine prophylaxis was assessed using the individual annualised bleeding rates (spontaneous and traumatic bleeding episodes per patient per year).|52 weeks after treatment start for patients on prophylaxis|Full analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.|||bleeds/patient/year||Inter-Quartile Range|Median
2688467|NCT01333059|Primary|Duration of Mechanical Ventilation Days|Participants will be followed for an expected average of 4 days. The Data Safety Monitoring Group will review the data every 6 months.|From date of randomization until the date of discharge from PICU, assessed up to 1 month|In October of 2012, the DSMB unanimously voted to close this study due to safety concerns and inactivity. The Board noted that recruitment goals had not been met and statistical analysis could not be made with current data.|||days||Standard Deviation|Mean
2688456|NCT01333111|Secondary|Haemostatic Effect of NNC-0156-0000-0009 When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response|"Haemostatic response after treatment of a bleed with nonacog beta pegol was evaluated on a 4 point scale as excellent, good, moderate or poor. A success rate was calculated based on counting good or excellent as successes and poor and moderate as failures.~Excellent - abrupt pain relief and/or clear improvement in objective signs of bleeding within 8 hours after a single injection~Good - noticeable pain relief and/or improvement in signs of bleeding within 8 hours after a single injection~Moderate - probable or slight beneficial effect within the first 8 hours after the first injection but requiring more than one injection within 8 hours~Poor - no improvement, or worsening of symptoms within 8 hours after two injections.~The success rate and 95% confidence interval (CI) are reported here."|28 weeks after treatment start on on-demand treatment|Full analysis set included all subjects exposed to nonacog beta pegol. Subjects in on-demand arm were included for this analysis.|||percentage of bleeding episodes||95% Confidence Interval|Number
2688457|NCT01333111|Secondary|Haemostatic Effect of NNC-0156-0000-0009 When Used for Prophylaxis of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response|"Haemostatic response after treatment of a bleed with nonacog beta pegol was evaluated on a 4 point scale as excellent, good, moderate or poor. A success rate was calculated based on counting good or excellent as successes and poor and moderate as failures.~Excellent - abrupt pain relief and/or clear improvement in objective signs of bleeding within 8 hours after a single injection~Good - noticeable pain relief and/or improvement in signs of bleeding within 8 hours after a single injection~Moderate - probable or slight beneficial effect within the first 8 hours after the first injection but requiring more than one injection within 8 hours~Poor - no improvement, or worsening of symptoms within 8 hours after two injections.~The success rate and 95% confidence interval (CI) are reported here."|52 weeks after treatment start for patients on prophylaxis|Full analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.|||percentage of bleeding episodes||95% Confidence Interval|Number
2688458|NCT01333111|Primary|Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units)|Inhibitors were analysed with either the Nijmegen modified factor IX Bethesda assay or a heat/cold Nijmegen modified factor IX Bethesda assay. Number of subjects who developed inhibitory antibodies against factor IX are reported.|28 weeks after treatment start on on-demand treatment|Full analysis set included all subjects exposed to nonacog beta pegol. Subjects in on-demand arm were included for this analysis.|||number of subjects|||Number
2688459|NCT01333111|Primary|Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units)|Inhibitors were analysed with either the Nijmegen modified factor IX Bethesda assay or a heat/cold Nijmegen modified factor IX Bethesda assay. Number of subjects who developed inhibitory antibodies against factor IX are reported.|52 weeks after treatment start for patients on prophylaxis|Full analysis set included all subjects exposed to nonacog beta pegol. Subjects in prophylaxis arm were included for this analysis.|||Number of subjects|||Number
2688460|NCT01333098|Secondary|Anxiety Symptoms|Self-report assessment of worry using Penn State Worry Questionnaire- Abbreviated, an 8-item measure (range 8-40 with high scores indicating higher levels of anxiety and worry symptoms.The average score for older adults with generalized anxiety disorder is 22, while the mean score for healthy older adults is 15.|baseline, week 4, week 12||||Scores on a scale||Standard Error|Mean
2688461|NCT01333098|Primary|Cognitive Changes Over Time, as Measured by Between Group and Within-subjects Comparison of Neuropsychological Measures.|Memory composite z-score: The two memory measures were a 16-word list recall similar to the Rey auditory verbal learning test, which has been used by the Washington University Alzheimer's Disease Research Center; and two paragraphs from a set of paragraph recall tests validated as sensitive to effects of stress-level glucocorticoids. For each memory variable, a z score was computed for each participant, where z score = (participant score mean)/standard deviation. Then a single composite memory variable was created by summing up these z scores. Summed Z-scores range from -6 to 6, with scores above 0 being higher than the mean.|Baseline, Week 4, Week 12||||z-score||Standard Error|Mean
2688462|NCT01333098|Primary|Number of Participants With Self-reported Side Effects||4 weeks||||participants with reported side effects|||Number
2688463|NCT01333098|Primary|Drug Acceptability, as Measured by Number of Participants With Dose-limiting Side Effects|number of participants with dose-limiting side effects|Baseline, Week 2, Week 4||||Participants|||Count of Participants
2688464|NCT01333072|Primary|Changes in the Irritability Subscale of the Larger ABC (Abberent Behavior Checklist) That Occur From Baseline to 10 Weeks|"Multi-center, blinded clinical trial to evaluate biomarkers as predictors of efficacy and safety in children with autistic disorder to risperidone, an atypical antipsychotic drug and aripiprazole, an antipsychotic having a unique clinical and receptor-binding profile.~The major outcome measure was the score on the Irritability subscale of the Aberrant Behavior Checklist (ABC-I) . The ABC has 58 items describing some aspect of behavior and the Irritability sub-scale has 15 items, each completed by a parent or caregiver under the supervision of an investigator. Scores on each item range from 0 = no problem and 3 = severe problem (range of total scores 0 to 45). A fall in scores indicates behavioral improvement."|baseline to 10 weeks|Score on Aberrant Behavior Checklist (ABC) scale for Irritability|||units on a scale||Standard Deviation|Mean
2688465|NCT01333059|Secondary|Hospital Length of Stay|Participants will be followed for an expected average of 7 days in PICU and 10 days of hospitalization. This secondary endpoint is to be evaluated every six months.|From date of hospital admission to date of hospital discharge, assessed up to 6 weeks|In October of 2012, the DSMB unanimously voted to close this study due to safety concerns and inactivity. The Board noted that recruitment goals had not been met and statistical analysis could not be made with current data|||days||Standard Deviation|Mean
2688466|NCT01333059|Secondary|PICU Length of Stay|Participants will be followed for an expected average of 7 days. This secondary endpoint is to be evaluated every six months.|From date of randomization until the date of discharge from PICU, assessed up to 1 month|In October of 2012, the DSMB unanimously voted to close this study due to safety concerns and inactivity. The Board noted that recruitment goals had not been met and statistical analysis could not be made with current data.|||days||Standard Deviation|Mean
2693860|NCT01290822|Secondary|Interatrial Delay (Between Right Atrium and Left Atrium)|Results could not be analyzed due to poor enrollment and lack of data.|13 minutes of testing; performed before CPB for allograft receipt|||||||
2688468|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using FACIT Among Nonresponding Participants Treated With Rituximab|The FACIT-F evaluates quality of life using 5 categories: PWB, SWB, EWB, FWB, and FS. Participants answer each item on a 5-point scale from 0 to 4. The total score is the sum of individual responses across all 5 categories and may range from 0 to 160. The FACIT-G (range 0 to 108) is the sum of scores for PWB, SWB, EWB, and FWB; the FACIT-F TOI (range 0 to 108) is the sum of scores for PWB, FWB, and FS; and the FACIT-F fatigue (range 0 to 52) is the sum of scores for the FS only. For derivations of the FACIT-F reported here, higher scores indicate better quality of life. The mean score at each timepoint was determined by averaging scores among all participants, and the change in score was calculated as [mean score at Week 32 minus mean score at Week 16].|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.|||units on a scale||Standard Deviation|Mean
2688469|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using FACIT Among Participants Treated With 8 Courses of Tocilizumab|The FACIT-F evaluates quality of life using 5 categories: PWB, SWB, EWB, FWB, and FS. Participants answer each item on a 5-point scale from 0 to 4. The total score is the sum of individual responses across all 5 categories and may range from 0 to 160. The FACIT-G (range 0 to 108) is the sum of scores for PWB, SWB, EWB, and FWB; the FACIT-F TOI (range 0 to 108) is the sum of scores for PWB, FWB, and FS; and the FACIT-F fatigue (range 0 to 52) is the sum of scores for the FS only. For derivations of the FACIT-F reported here, higher scores indicate better quality of life. The mean score at each timepoint was determined by averaging scores among all participants, and the change in score was calculated as [mean score at Week 32 minus mean score at Week 16].|Weeks 16 and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
2688470|NCT01332994|Secondary|Change From Baseline in Quality of Life as Assessed Using FACIT at Week 16|The FACIT-F evaluates quality of life using 5 categories: PWB, SWB, EWB, FWB, and FS. Participants answer each item on a 5-point scale from 0 to 4. The total score is the sum of individual responses across all 5 categories and may range from 0 to 160. The FACIT-G (range 0 to 108) is the sum of scores for PWB, SWB, EWB, and FWB; the FACIT-F TOI (range 0 to 108) is the sum of scores for PWB, FWB, and FS; and the FACIT-F fatigue (range 0 to 52) is the sum of scores for the FS only. For derivations of the FACIT-F reported here, higher scores indicate better quality of life. The mean score at each timepoint was determined by averaging scores among all participants, and the change in score was calculated as [mean score at Week 16 minus mean score at Baseline].|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
2688471|NCT01332994|Secondary|Quality of Life as Assessed Using Functional Assessment of Chronic Illness Therapy (FACIT)|The FACIT-F evaluates quality of life using 5 categories: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and fatigue (FS). Participants answer each item on a 5-point scale from 0 to 4. The total score is the sum of individual responses across all 5 categories and may range from 0 to 160. The FACIT-General (FACIT-G; range 0 to 108) is the sum of scores for PWB, SWB, EWB, and FWB; the FACIT-Fatigue (FACIT-F) trial outcome index (TOI; range 0 to 108) is the sum of scores for PWB, FWB, and FS; and the FACIT-F fatigue (range 0 to 52) is the sum of scores for the FS only. For derivations of the FACIT-F reported here, higher scores indicate better quality of life. The mean score at each timepoint was determined by averaging scores among all participants.|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
2688472|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to HAQ-DI Criteria|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. Response was defined as a change in index score >0.22 from Baseline to Week 16.|Baseline and Week 16|Main ITT Population|||percentage of participants|||Number
2688473|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using HAQ-DI Among Nonresponding Participants Treated With Rituximab|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. The mean index score at each timepoint was determined by averaging the scores among all participants, and the change in score was calculated as [mean score at Week 32 minus the mean score at Week 16].|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.|||units on a scale||Standard Deviation|Mean
2688474|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using HAQ-DI Among Participants Treated With 8 Courses of Tocilizumab|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. The mean index score at each timepoint was determined by averaging the scores among all participants, and the change in score was calculated as [mean score at Week 32 minus the mean score at Week 16].|Weeks 16 and 32|ITT2 Population. Participants with evaluable data at the designated visit were included.|||units on a scale||Standard Deviation|Mean
2688490|NCT01332994|Secondary|Change From Baseline in CRP at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Blood samples for laboratory assessments, including CRP level, were collected prior to each dose of study medication. The mean CRP level was determined at Baseline and for assessment visits by averaging the observed CRP level among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean CRP at the assessment visit minus mean CRP at Baseline] and expressed in mg/dL.|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||mg/dL||Standard Deviation|Mean
2688475|NCT01332994|Secondary|Change From Baseline in Quality of Life as Assessed Using HAQ-DI at Week 16|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. The mean index score at each timepoint was determined by averaging the scores among all participants, and the change in score was calculated as [mean score at Week 16 minus mean score at Baseline].|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit were included.|||units on a scale||Standard Deviation|Mean
2688476|NCT01332994|Secondary|Quality of Life as Assessed Using HAQ-DI|The HAQ-DI evaluates participant-reported quality of life using 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other common activities such as running errands and performing household chores. Each category contains multiple questions, which are answered using a 4-point scale from 0 to 3. The overall index score is taken as an average of the individual item responses and may range from 0 to 3, where higher scores indicate more difficulty in daily living activities. The mean index score at each timepoint was determined by averaging the scores among all participants.|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
2688477|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using SF-36 Scores Among Nonresponding Participants Treated With Rituximab|The SF-36 evaluates participant-rated quality of life using 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for each section is the average of the individual question scores, which are scaled from 0 to 100, with higher scores indicating better functioning. The mean score at each timepoint was determined by averaging the scores among all participants, and the change in each domain score was calculated as [mean score at Week 32 minus mean score at Week 16].|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
2688478|NCT01332994|Secondary|Change From Week 16 to 32 in Quality of Life as Assessed Using SF-36 Scores Among Participants Treated With 8 Courses of Tocilizumab|The SF-36 evaluates participant-rated quality of life using 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for each section is the average of the individual question scores, which are scaled from 0 to 100, with higher scores indicating better functioning. The mean score at each timepoint was determined by averaging the scores among all participants, and the change in each domain score was calculated as [mean score at Week 32 minus mean score at Week 16].|Weeks 16 and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
2688479|NCT01332994|Secondary|Change From Baseline in Quality of Life as Assessed Using SF-36 at Week 16|The SF-36 evaluates participant-rated quality of life using 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for each section is the average of the individual question scores, which are scaled from 0 to 100, with higher scores indicating better functioning. The mean score at each timepoint was determined by averaging the scores among all participants, and the change in each domain score was calculated as [mean score at Week 16 minus mean score at Baseline].|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
2688480|NCT01332994|Secondary|Quality of Life as Assessed Using Short Form 36 (SF-36)|The SF-36 evaluates participant-rated quality of life using 8 domains: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for each section is the average of the individual question scores, which are scaled from 0 to 100, with higher scores indicating better functioning. The mean score at each timepoint was determined by averaging the scores among all participants.|Baseline and Week 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
2688481|NCT01332994|Secondary|Mean Number of Work Days Missed Per Week|Work days missed were documented by reason (either rheumatoid arthritis [RA] or other reasons) for each participant over the preceding 7-day period. The mean number of work days missed was calculated by averaging the number of days missed per week among all participants.|Baseline and Week 16|Main ITT Population. Employed participants with evaluable data at the designated visit (number shown = n) were included.|||days||Standard Deviation|Mean
2688482|NCT01332994|Secondary|Spearman's Rank Correlation Coefficient Between Percentage of B-Cells at Baseline and Difference in DAS28 Scores Between Baseline and Weeks 16, 32, 40, 48, and 66 Among Nonresponding Participants Treated With Rituximab|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional, naïve, pre-switch memory, post-switch memory, IgG-positive class-switched, IgA-positive class-switched, double-negative memory, and plasmablasts. Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined. Extent of disease response, using change from Baseline in DAS28 score, was correlated to the percentage of B-cells within each subpopulation at Baseline. Correlation is indicated by a correlation coefficient (r) >0.2, with greater values indicating a stronger correlation.|Baseline and Weeks 16, 32, 40, 48, and 66|ITT3 Population; n = number of data pairs included in the analysis.|||coefficient|Participants||Number
2688491|NCT01332994|Secondary|Change From Baseline in Hemoglobin at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Blood samples for laboratory assessments, including hemoglobin level, were collected prior to each dose of study medication. The mean hemoglobin level was determined at Baseline and for assessment visits by averaging the observed hemoglobin level among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean hemoglobin at the assessment visit minus mean hemoglobin at Baseline] and expressed in g/L.|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||g/L||Standard Deviation|Mean
2710804|NCT01167829|Secondary|Maximum Sex Hormone-Binding Globulin (SHGB)Concentration||baseline & day 9||||ng/dL||Geometric Coefficient of Variation|Geometric Mean
2688483|NCT01332994|Secondary|Spearman's Rank Correlation Coefficient Between Percentage of B-Cells at Baseline and Difference in DAS28 Scores Between Baseline and Weeks 16, 24, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional, naïve, pre-switch memory, post-switch memory, IgG-positive class-switched, IgA-positive class-switched, double-negative memory, and plasmablasts. Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined. Extent of disease response, using change from Baseline in DAS28 score, was correlated to the percentage of B-cells within each subpopulation at Baseline. Correlation is indicated by a correlation coefficient (r) >0.2, with greater values indicating a stronger correlation.|Baseline and Weeks 16, 24, and 32|ITT2 Population; n = number of data pairs included in the analysis.|||coefficient|Participants||Number
2688484|NCT01332994|Secondary|Spearman's Rank Correlation Coefficient Between Percentage of B-Cells at Baseline and Difference in DAS28 Scores Between Baseline and Week 16 Among Participants With Early Remission|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional, naïve, pre-switch memory, post-switch memory, IgG-positive class-switched, IgA-positive class-switched, double-negative memory, and plasmablasts. Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined. Extent of disease response, using change from Baseline to Week 16 in DAS28 score, was correlated to the percentage of B-cells within each subpopulation at Baseline. Correlation is indicated by a correlation coefficient (r) >0.2, with greater values indicating a stronger correlation.|Baseline and Week 16|ITT1 Population; n = number of data pairs included in the analysis.|||coefficient|Participants||Number
2688485|NCT01332994|Secondary|Percentage of B-Cells at Baseline by B-Cell Subpopulation Among Nonresponding Participants Treated With Rituximab|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional (cluster of differentiation [CD] 19-positive, immunoglobulin (Ig) D-positive, CD38 medium, CD10-positive); naive (CD19-positive, IgD-positive, CD38 medium, CD27-negative); pre-switch memory (CD19-positive, CD27-positive, IgD-positive); post-switch memory (CD19-positive, CD27-positive, IgD-negative); IgG-positive class-switched (CD19-positive, IgG-positive); IgA-positive class-switched (CD19-positive, IgA-positive); double-negative memory (CD19-positive, IgD-negative, CD27-negative); and plasmablasts (CD19-positive, IgD-negative, CD38 high, CD27 high). Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined.|Baseline|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||percentage of B-cells||Full Range|Median
2688486|NCT01332994|Secondary|Percentage of B-Cells at Baseline by B-Cell Subpopulation Among Participants Treated With 8 Courses of Tocilizumab|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional (cluster of differentiation [CD] 19-positive, immunoglobulin (Ig) D-positive, CD38 medium, CD10-positive); naive (CD19-positive, IgD-positive, CD38 medium, CD27-negative); pre-switch memory (CD19-positive, CD27-positive, IgD-positive); post-switch memory (CD19-positive, CD27-positive, IgD-negative); IgG-positive class-switched (CD19-positive, IgG-positive); IgA-positive class-switched (CD19-positive, IgA-positive); double-negative memory (CD19-positive, IgD-negative, CD27-negative); and plasmablasts (CD19-positive, IgD-negative, CD38 high, CD27 high). Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined.|Baseline|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||percentage of B-cells||Full Range|Median
2688487|NCT01332994|Secondary|Percentage of B-Cells at Baseline by B-Cell Subpopulation Among Participants With Early Remission|Blood samples were collected to analyze total B-cell panel via immunophenotyping. Subpopulations were as follows: transitional (cluster of differentiation [CD] 19-positive, immunoglobulin (Ig) D-positive, CD38 medium, CD10-positive); naive (CD19-positive, IgD-positive, CD38 medium, CD27-negative); pre-switch memory (CD19-positive, CD27-positive, IgD-positive); post-switch memory (CD19-positive, CD27-positive, IgD-negative); IgG-positive class-switched (CD19-positive, IgG-positive); IgA-positive class-switched (CD19-positive, IgA-positive); double-negative memory (CD19-positive, IgD-negative, CD27-negative); and plasmablasts (CD19-positive, IgD-negative, CD38 high, CD27 high). Naive B-cell compartment was defined as the sum of transitional and naive B-cells. The sum of memory B-cell subsets with or without double-negative B-cells was also determined.|Baseline|ITT1 Population: All participants who received at least one dose of TCZ in the first treatment period and who completed the study reaching remission at Week 16. Participants with evaluable data at the designated visit (number shown = n) were included.|||percentage of B-cells||Full Range|Median
2688488|NCT01332994|Secondary|Percentage of Participants Withdrawing From the Study for Insufficient Therapeutic Response|Study discontinuation was documented by reason for each participant prematurely withdrawing from the study. The percentage of participants was calculated as the number withdrawing for insufficient therapeutic response divided by the total number of participants who began treatment.|Baseline to Week 16|Main ITT Population. Participants who withdrew for reasons other than insufficient therapeutic response were not included in the analysis.|||percentage of participants||95% Confidence Interval|Number
2688489|NCT01332994|Secondary|Change From Baseline in ESR at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Blood samples for laboratory assessments, including ESR, were collected prior to each dose of study medication. The mean ESR was determined at Baseline and for assessment visits by averaging the observed ESR among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean ESR at the assessment visit minus mean ESR at Baseline] and expressed in mm/h.|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||mm/h||Standard Deviation|Mean
2688492|NCT01332994|Secondary|Change in ESR From Week 16 to 32 Among Nonresponding Participants Treated With Rituximab|Blood samples for laboratory assessments, including ESR, were collected prior to each dose of study medication. The mean ESR was determined at Baseline and for assessment visits by averaging the observed ESR among all participants providing evaluable blood samples. Change was calculated as [mean ESR at Week 32 minus mean ESR at Week 16] and expressed in mm/h.|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.|||mm/h||Standard Deviation|Mean
2688493|NCT01332994|Secondary|Change in CRP From Week 16 to 32 Among Nonresponding Participants Treated With Rituximab|Blood samples for laboratory assessments, including CRP level, were collected prior to each dose of study medication. The mean CRP level was determined at Baseline and for assessment visits by averaging the observed CRP level among all participants providing evaluable blood samples. Change was calculated as [mean CRP at Week 32 minus mean CRP at Week 16] and expressed in mg/dL.|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.|||mg/dL||Standard Deviation|Mean
2688494|NCT01332994|Secondary|Change in Hemoglobin From Week 16 to 32 Among Nonresponding Participants Treated With Rituximab|Blood samples for laboratory assessments, including hemoglobin level, were collected prior to each dose of study medication. The mean hemoglobin level was determined at Baseline and for assessment visits by averaging the observed hemoglobin level among all participants providing evaluable blood samples. Change was calculated as [mean hemoglobin at Week 32 minus mean hemoglobin at Week 16] and expressed in g/L.|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit were included.|||g/L||Standard Deviation|Mean
2688495|NCT01332994|Secondary|Change From Baseline in ESR at Weeks 4, 8, 12, and 16|Blood samples for laboratory assessments, including ESR, were collected prior to each dose of study medication. The mean ESR was determined at Baseline and for assessment visits by averaging the observed ESR among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean ESR at the assessment visit minus mean ESR at Baseline] and expressed in millimeters per hour (mm/h).|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||mm/h||Standard Deviation|Mean
2688496|NCT01332994|Secondary|Change From Baseline in CRP at Weeks 4, 8, 12, and 16|Blood samples for laboratory assessments, including CRP level, were collected prior to each dose of study medication. The mean CRP level was determined at Baseline and for assessment visits by averaging the observed CRP level among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean CRP at the assessment visit minus mean CRP at Baseline] and expressed in milligrams per deciliter (mg/dL).|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||mg/dL||Standard Deviation|Mean
2688497|NCT01332994|Secondary|Change From Baseline in Hemoglobin at Weeks 4, 8, 12, and 16|Blood samples for laboratory assessments, including hemoglobin level, were collected prior to each dose of study medication. The mean hemoglobin level was determined at Baseline and for assessment visits by averaging the observed hemoglobin level among all participants providing evaluable blood samples. Change from Baseline was calculated as [mean hemoglobin at the assessment visit minus mean hemoglobin at Baseline] and expressed in grams per liter (g/L).|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||g/L||Standard Deviation|Mean
2688498|NCT01332994|Secondary|Change From Baseline in CDAI and SDAI Scores at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|The CDAI was calculated as [SJC + TJC + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. The SDAI was determined by adding CRP level to the CDAI score. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. A reduction in either score at the assessment visit reflects improvement in disease.|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
2688499|NCT01332994|Secondary|Change From Week 16 to 32 in CDAI and SDAI Scores Among Nonresponding Participants Treated With Rituximab|The CDAI was calculated as [SJC + TJC + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. The SDAI was determined by adding CRP level to the CDAI score. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. A reduction in either score at the assessment visit reflects improvement in disease.|Weeks 16 and 32|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
2688500|NCT01332994|Secondary|Change From Baseline in Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Scores at Weeks 4, 8, 12, and 16|The CDAI was calculated as [SJC + TJC + VAS patient global assessment of disease activity + VAS physician global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. The SDAI was determined by adding CRP level to the CDAI score. Scores ranged from 0 to 86, with higher scores also indicating increased disease activity. A reduction in either score at the assessment visit reflects improvement in disease.|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
2688501|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to ACR Criteria at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Response was determined using ACR criteria based upon assessment of 66 joints for swelling and 68 joints for tenderness; joints were classified dichotomously as swollen or not swollen and tender or not tender. Respectively, these assessments were used to generate an SJC ranging from 0 to 66 swollen joints and a TJC ranging from 0 to 68 tender joints. Response was defined as a reduction from Baseline of at least 20% for one of the following: VAS scores for patient-reported pain, patient global assessment of disease activity, or physician global assessment of disease activity, HAQ-DI, or CRP; plus a reduction in individual SJC and TJC of 20% (ACR20), 50% (ACR50), or 70% (ACR70). VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.'|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population|||percentage of participants||95% Confidence Interval|Number
2688714|NCT01332188|Secondary|Nasal Pruritus at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688502|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to ACR Criteria at Week 32 Compared to Week 16 Among Nonresponding Participants Treated With Rituximab|Response was determined using ACR criteria based upon assessment of 66 joints for swelling and 68 joints for tenderness; joints were classified dichotomously as swollen or not swollen and tender or not tender. Respectively, these assessments were used to generate an SJC ranging from 0 to 66 swollen joints and a TJC ranging from 0 to 68 tender joints. Response was defined as a reduction from the reference visit (Week 16) of at least 20% for one of the following: VAS scores for patient-reported pain, patient global assessment of disease activity, or physician global assessment of disease activity, HAQ-DI, or CRP; plus a reduction in individual SJC and TJC of 20% (ACR20), 50% (ACR50), or 70% (ACR70). VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.'|Weeks 16 and 32|ITT3 Population|||percentage of participants||95% Confidence Interval|Number
2688503|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to American College of Rheumatology (ACR) Criteria at Weeks 4, 8, 12, and 16|Response was determined using ACR criteria based upon assessment of 66 joints for swelling and 68 joints for tenderness; joints were classified dichotomously as swollen or not swollen and tender or not tender. Respectively, these assessments were used to generate a swollen joint count (SJC) ranging from 0 to 66 swollen joints and a tender joint count (TJC) ranging from 0 to 68 tender joints. Response was defined as a reduction from Baseline of at least 20% for one of the following: VAS scores for patient-reported pain, patient global assessment of disease activity, or physician global assessment of disease activity, Health Assessment Questionnaire Disability Index (HAQ-DI), or C-reactive protein (CRP); plus a reduction in individual SJC and TJC of 20% (ACR20), 50% (ACR50), or 70% (ACR70). VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.'|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population|||percentage of participants||95% Confidence Interval|Number
2688504|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to EULAR Criteria at Weeks 20, 24, 28, and 32 Among Participants Treated With 8 Courses of Tocilizumab|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.'|Baseline and Weeks 20, 24, 28, and 32|ITT2 Population|||percentage of participants||95% Confidence Interval|Number
2688505|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to EULAR Criteria at Week 32 Compared to Week 16 Among Nonresponding Participants Treated With Rituximab|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from the reference visit (Week 16). Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.'|Weeks 16 and 32|ITT3 Population|||percentage of participants||95% Confidence Interval|Number
2688506|NCT01332994|Secondary|Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Weeks 4, 8, 12 and 16|Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score ≤3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score ≤5.1 with reduction of >0.6 to ≤1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to ≤1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.'|Baseline and Weeks 4, 8, 12, and 16|Main ITT Population|||percentage of participants||95% Confidence Interval|Number
2688507|NCT01332994|Secondary|DAS28 Scores During Safety Follow-Up Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity.|Weeks 40, 48, 56, and 66|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
2688508|NCT01332994|Secondary|DAS28 Scores During and After Treatment Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity.|Baseline and Weeks 4, 8, 12, 16, 24, and 32|ITT3 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
2688509|NCT01332994|Secondary|DAS28 Scores During and After Treatment Among Participants Treated With 8 Courses of Tocilizumab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity.|Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, and 32|ITT2 Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
2688715|NCT01332188|Secondary|Nasal Pruritus at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688510|NCT01332994|Secondary|DAS28 Scores During and After Treatment|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity.|Baseline and Weeks 4, 8, 12, 16|Main ITT Population. Participants with evaluable data at the designated visit (number shown = n) were included.|||units on a scale||Standard Deviation|Mean
2688511|NCT01332994|Secondary|Percentage of Participants Achieving a Clinically Relevant Reduction in DAS28 From Week 16 to Week 32 Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Reductions >1.2 points from the reference visit (Week 16) to the assessment visit were considered clinically relevant.|Weeks 16 and 32|ITT3 Population: All participants who received at least one dose of TCZ in the first treatment period and at least one dose of RTX in the second treatment period with at least one efficacy measurement under RTX.|||percentage of participants||95% Confidence Interval|Number
2688512|NCT01332994|Secondary|Percentage of Participants Achieving a Clinically Relevant Reduction From Baseline in DAS28 at Weeks 4, 8, and 12|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Reductions >1.2 points from Baseline to the assessment visit were considered clinically relevant.|Baseline and Weeks 4, 8, and 12|Main ITT Population|||percentage of participants||95% Confidence Interval|Number
2688513|NCT01332994|Secondary|Percentage of Participants Achieving a Clinically Relevant Reduction From Baseline in DAS28 at Week 16|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Reductions >1.2 points from Baseline to the assessment visit were considered clinically relevant.|Baseline and Week 16|Main ITT Population|||percentage of participants||95% Confidence Interval|Number
2688514|NCT01332994|Secondary|Percentage of Participants Achieving LDAS According to DAS28 Among Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x the patient global assessment of disease activity using a VAS]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. LDAS was defined as a DAS28 score <3.2 at the assessment visit.|Week 32|ITT3 Population|||percentage of participants||95% Confidence Interval|Number
2688515|NCT01332994|Secondary|Percentage of Participants Achieving Low Disease Activity Score (LDAS) According to DAS28|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x the patient global assessment of disease activity using a VAS]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. LDAS was defined as a DAS28 score <3.2 at the assessment visit.|Week 16|Main ITT Population|||percentage of participants||95% Confidence Interval|Number
2688516|NCT01332994|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Week 32 Among Nonresponding Participants Treated With Rituximab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Week 32|ITT3 Population|||percentage of participants||95% Confidence Interval|Number
2688517|NCT01332994|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Week 32 Among Participants Treated With 8 Courses of Tocilizumab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Week 32|ITT2 Population|||percentage of participants||95% Confidence Interval|Number
2688518|NCT01332994|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Weeks 16, 20, 24, and 28 Among Participants Treated With 8 Courses of Tocilizumab|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Weeks 16, 20, 24, and 28|ITT2 Population: All participants who received at least one dose of TCZ in the first treatment period with at least one efficacy measurement under TCZ, receiving TCZ in the second treatment period.|||percentage of participants||95% Confidence Interval|Number
2688716|NCT01332188|Secondary|Nasal Pruritus at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688519|NCT01332994|Secondary|Percentage of Participants Achieving Remission According to DAS28 at Weeks 4, 8, and 12|The DAS28 was calculated as [0.28 x the square root of number of swollen joints] + [0.56 x the square root of number of tender joints] + [0.7 x the natural log of ESR] + [0.014 x VAS patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Weeks 4, 8, and 12|Main ITT Population|||percentage of participants||95% Confidence Interval|Number
2688520|NCT01332994|Primary|Percentage of Participants Achieving Remission at Week 16 According to DAS28|The DAS28 was calculated as [0.28 times (x) the square root of number of swollen joints] plus (+) [0.56 x the square root of number of tender joints] + [0.7 x the natural log of erythrocyte sedimentation rate (ESR)] + [0.014 x Visual Analog Scale (VAS) patient global assessment of disease activity]. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity.' DAS28 scores ranged from 0 to 10, with higher scores indicating increased disease activity. Remission was defined as a DAS28 score <2.6 at the assessment visit.|Week 16|Main ITT Population|||percentage of participants||95% Confidence Interval|Number
2688521|NCT01332981|Secondary|Prognostic Factors For Time to Progression|Prognostic factors for TTP were searched by using Cox regression model. First, all parameters were analysed in univariate models, and the hypothesis of proportional risks was tested. Significant parameters at 15% level were retained for multivariate model. For multivariate analyses, 2 models were built for prognostic factor of TTP. In Model 1, stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters. In Model 2, stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for exit was 5%. Six parameters remained in the Model 1 to search for prognostic factors of TTP. Once the correlated variables were removed, there were only 3 variables left in Model 2: the age was not kept by the stepwise selection. Results below are for Model 1 and similar results were obtained for Model 2|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.|||Hazard Ratio||95% Confidence Interval|Number
2688522|NCT01332981|Secondary|Prognostic Factors for Overall Survival|Search for prognostic factors for OS was performed using Cox regression model. First, all parameters were analyzed in univariate models, and the hypothesis of proportional risks was tested. Significant parameters at 15%-level were retained for the multivariate model. For the multivariate analysis, two models were built for prognostic factors for OS. In the first one (Model 1), a stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters. In the second one (Model 2), a stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for removal was 5%. The variables n°5 and n°6 were found to be significantly associated, thus only the variable n°6 was tested in the Model 2. This variable was not retained by the stepwise selection in the Model 1, contrary to the variable n°5.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.|||Hazard Ratio||95% Confidence Interval|Number
2688523|NCT01332981|Secondary|Median Treatment Duration and the Duration of Exposure to Trastuzumab|Treatment duration was defined as the time between the first and the last infusion of trastuzumab. Exposure duration was defined only for the participants who continued trastuzumab after HERMINE study, as the sum of treatment duration as part of HERMINE study and of the treatment durations as part of post-HERMINE study taking into account temporary treatment discontinuations. For analyses of treatment and exposure duration , dates of infusion of trastuzumab were missing for 18 participants, so treatment and exposure durations were calculated for only 202 participants.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.|||Years||Full Range|Median
2688524|NCT01332981|Secondary|Median Time to Progression|The Time to Progression (TTP) was defined as the time between the treatment start date (date of the first trastuzumab infusion) and the date of the first disease progression or disease-related death. Participants who had not progressed at the end of the post-HERMINE study were censored at the last date they were known to be alive. If the cause of death was unknown, the death was considered for this analysis as due to the disease. All participants who did not progress, the death was considered to be due to the disease.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.|||Years||95% Confidence Interval|Median
2688525|NCT01332981|Secondary|Median Time to Progression-Free Survival|The Progression-Free Survival (PFS) was defined as the time between the treatment start date (date of the first trastuzumab infusion) and the date of the first disease progression or disease-related death. Participants who had not progressed at the end of the post-HERMINE study were censored at the last date they were known to be alive. Progression-Free Survival was estimated by using Kaplan-Meier method.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.|||Years||95% Confidence Interval|Median
2688526|NCT01332981|Primary|Median Overall Survival|The time between the first infusion of trastuzumab and the date of death from any cause. Participants who were still alive at the end of the post-HERMINE study or lost to follow-up were censored at the last date they were known to be alive.|Up to 7 years|Participants with HER2+ metastatic breast cancer included in HERMINE study and treated with trastuzumab as first line therapy.|||Years||95% Confidence Interval|Median
2688535|NCT01332968|Secondary|Time to Next Anti-Lymphoma Treatment (Overall Study Population)|Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event.|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688717|NCT01332188|Secondary|Rhinorrhea at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688527|NCT01332968|Secondary|Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase|The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs in data categories. Completion includes completion visit and early termination visit.|Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 after Day 1 of last induction cycle, Follow-up: every year for up to data cut-off (up to 4 years and 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||units on a scale||Standard Deviation|Mean
2688528|NCT01332968|Secondary|Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase|The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1 Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs. Completion includes completion visit and early termination visit.|Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 4 years and 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||units on a scale||Standard Deviation|Mean
2688529|NCT01332968|Secondary|Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase|The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Completion (Compl) includes completion visit and early termination visit. Maintenance/Observation is indicated as Maint/Obs.|Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 4 years and 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||units on a scale||Standard Deviation|Mean
2688530|NCT01332968|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population)|The FACT-Lym Total Score for the follicular lymphoma population was derived from the following 5 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24),Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym Total Score is the sum of all 5 individual subscales (range 0-168). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.|Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months)|The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.|||units on a scale||Standard Deviation|Mean
2688531|NCT01332968|Secondary|Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population)|The FACT-Lym Individual Subscale Lymphoma Score for the follicular lymphoma population was derived from the Lymphoma subscale questionnaire (range: 0-60). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.|Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months)|The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.|||units on a scale||Standard Deviation|Mean
2688532|NCT01332968|Secondary|Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population)|The FACT-Lym TOI Score for the follicular lymphoma population was derived from the following 3 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym TOI Score is the sum of the 3 individual subscales (range 0-116). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.|Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months)|The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.|||units on a scale||Standard Deviation|Mean
2688533|NCT01332968|Secondary|Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population)|FACT-G consists of the following 4 FACT-Lym sub-questionnaires: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24) and Functional Well-being (range: 0-28). Higher scores indicate better outcomes. A positive change from baseline indicates improvement. Maint = Maintenance period.|Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 4 years and 7 months)|The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.|||units on a scale||Standard Deviation|Mean
2688534|NCT01332968|Secondary|Percentage of Participants With Adverse Events|An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The safety analysis population included all participants who received any amount of any study drug and participants were analyzed according to the treatment received.|||percentage of participants|||Number
2688536|NCT01332968|Secondary|Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population)|Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause. Reported is the percentage of participants with event.|Baseline up to data cut-off (up to approximately 4 years and 7 months|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688537|NCT01332968|Secondary|Duration of Response (DOR) (Overall Study Population), Investigator-Assessed|DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm.|From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months)|Participants with CR or PR within the ITT population were included in the analysis. The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688538|NCT01332968|Secondary|Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed|DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm.|From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months|Participants with CR or PR within the FL ITT population were included in the analysis.The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688539|NCT01332968|Secondary|Disease-Free Survival (Overall Study Population)|Disease-free survival in the overall study population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Reported is the percentage of participants with event.|From first occurrence of documented CR to data cut-off (up to approximately 4 years and 7 months|Participants with CR within the ITT population were included in the analysis.The ITT population was defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688540|NCT01332968|Secondary|Disease-Free Survival (Follicular Lymphoma Population)|Disease-free survival in the follicular lymphoma population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma (RRCML). Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Reported is the percentage of participants with event.|From first occurrence of documented CR to data cut-off (up to approximately 4 years and 7 months)|Participants with CR within the FL ITT population were included in the analysis.The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688541|NCT01332968|Secondary|Event-Free Survival (Overall Study Population)|Event-free survival in the overall study population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with event.|Baseline up to data cut-off (up to approximately 4 years and 7 months|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688542|NCT01332968|Secondary|Event-Free Survival (Follicular Lymphoma Population)|Event-free survival in the follicular lymphoma population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with an event.|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688543|NCT01332968|Secondary|Overall Survival (Overall Study Population)|Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event.|Baseline up to data cut-off (up to approximately 4 years and 7 months|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688544|NCT01332968|Secondary|Overall Survival (Follicular Lymphoma Population)|Overall survival in the follicular lymphoma population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event.|Baseline up to data cut-off (up to approximately 4 years and 7 months|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688545|NCT01332968|Secondary|Complete Response (Overall Study Population), IRC-Assessed|Percentage of participants with complete response in the overall study population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.|Baseline up to end of induction period (up to approximately 7 months)]|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688546|NCT01332968|Secondary|Complete Response (Follicular Lymphoma Population), IRC-Assessed|Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.|Baseline up to end of induction period (up to approximately 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688547|NCT01332968|Secondary|Overall Response (Overall Study Population), IRC-Assessed|Overall response in the overall study population was defined as percentage of participants with PR or CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR.|Baseline up to end of induction period (up to approximately 7 months)|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688548|NCT01332968|Secondary|Overall Response (Follicular Lymphoma Population), IRC-Assessed|Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR.|Baseline up to end of induction period (up to approximately 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688549|NCT01332968|Secondary|Complete Response (Overall Study Population), Investigator-Assessed|Percentage of participants with complete response in the overall study population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.|Baseline up to end of induction period (up to approximately 7 months)|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688550|NCT01332968|Secondary|Complete Response (Follicular Lymphoma Population), Investigator-Assessed|Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.|Baseline up to end of induction period (up to approximately 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2690356|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 52).|The change between the value of fasting blood glucose collected at week 52 and baseline.|Baseline and Week 52.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2688551|NCT01332968|Secondary|Overall Response (Overall Study Population), Investigator-Assessed|Overall response in the overall study population was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without positron emission tomography (PET). CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR.|Baseline up to end of induction period (up to approximately 7 months)|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688552|NCT01332968|Secondary|Overall Response (Follicular Lymphoma Population), Investigator-Assessed|Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with and without PET. CR was defined as disappearance of all target lesions; PR was defined as >=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR.|Baseline up to end of induction period (up to approximately 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688553|NCT01332968|Secondary|Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC)|Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI.|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688554|NCT01332968|Secondary|Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed|Progression-free survival in the participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. In the first 170 patients with follicular lymphoma, an FDG-PET was mandatory where a PET scanner was available.|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The FL ITT population, defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688555|NCT01332968|Secondary|Progression-Free Survival in the Overall Study Population, Investigator-Assessed|Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI.|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The ITT population defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688556|NCT01332968|Primary|Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed|Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).|Baseline up to data cut-off (up to approximately 4 years and 7 months)|The intent-to-treat follicular lymphoma population (FL ITT), defined as all randomized participants with follicular histology, where participants were grouped according to their randomized treatment arm regardless of what treatments were actually received.|||percentage of participants with event|||Number
2688579|NCT01332578|Secondary|Time to Onset and Completion of Disintegration of Reference Tablets|Qualitative onset and completion of tablet disintegration was determined using Gamma scintigraphy images and WebLink image analysis program.|Baseline to 10 hours post dose|Period Level MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in one of the two study periods. Tablet Disintegration endpoints were only measured in the first period for each participant.|||minutes||Standard Deviation|Mean
2688557|NCT01332851|Secondary|Maternal Unrealistic Expectations|Parent Opinion Questionnaire (POQ; Azar et al., 1984): questionnaire to assess unrealistic parental expectations of child behavior in the areas of self-care, help and affection to parents, leaving children alone, proper feelings and behavior punishment, and family responsibility. NOTE: THIS MEASURE WAS COLLECTED. RESPONDENTS WERE OFFENDED BY SOME QUESTIONS, WE REDUCED THE NUMBER OF QUESTIONS AT BASELINE AND COLLECTED THE FULL INSTRUMENT AT FOLLOW UP 1. HOWEVER, IT SHOWED LIMITED VARIABILITY. COMPARISONS BETWEEN PFR AND R&R CONDITIONS INDICATED NONSIGNIFICANT DIFFERENCES. DUE TO THE LIMITED VARIABILITY, IT WAS DECIDED NOT TO REPORT THESE RESULTS.|Baseline and Post intervention (~ 4 months post baseline)|||||||
2688558|NCT01332851|Secondary|Parental Mindfulness|"About My Baby: three open-ended questions; coded to assess mindfulness representations of the child's mental life. NOTE: THIS MEASURE WAS DROPPED FROM THE STUDY. OPEN-ENDED QUESTIONS WERE INCLUDED IN INITIAL ASSESSMENTS. ANSWERS WERE REVIEWED BY THE RESEARCH TEAM, AND IT WAS DECIDED THAT RELIABLE AND VALID CODING WAS NOT POSSIBLE."|Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)|NOTE: THIS MEASURE WAS DROPPED FROM THE STUDY||||||
2688559|NCT01332851|Secondary|Parental Confidence|Caregiving Helplessness Questionnaire (CHQ; George, Coulson, Majany, & Soloman, 1995) subscales: parent-child frightened and parent helplessness. NOTE: THIS MEASURE WAS COLLECTED AND COMPARISONS BETWEEN PFR AND R&R INDICATED NONSIGNIFICANT DIFFERENCES. DUE TO LOW INTERNAL CONSISTENCY OF THE MEASURE, IT WAS DECIDED TO NOT REPORT PFR VS. R&R COMPARISONS FOR THIS MEASURE.|Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)|||||||
2688560|NCT01332851|Secondary|Parent-Child Interaction (Video Recorded Observation Coded by Blind Coders)|"Coding Interactive Behavior-Child & Parent Outcomes (CIB; Feldman, 1998). Parent-child 10-minute free play interaction coded for child social engagement, child negative affect, and dyadic reciprocity; parental sensitivity and reciprocity, parental intrusiveness, and parental withdrawal.~NOTE: THIS MEASURE WAS COLLECTED AND CODED. HOWEVER, THE MEASURE SUFFERED FROM LOW INTERNAL CONSISTENCY AND RESTRICTED VARIATION (I.E., A LARGE PORTION OF SCORES WERE NEAR THE MAXIMUM POSSIBLE VALUE). WE DID COMPARE SCORES BY CONDITION AND ALL COMPARISONS INDICATED NONSIGNIFICANT DIFFERENCES BETWEEN PFR AND R&R CONDITIONS. DUE TO LOW RELIABILITY AND RESTRICTED VARIATION OF THE MEASURE, IT WAS DECIDED TO NOT REPORT THESE RESULTS."|Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)|||||||
2688561|NCT01332851|Secondary|Child Atypical Affective Communication (Observation)|"Atypical, affective communication were measured with the Toddler Attachment Sort-45 (TAS-45; Kirkland, Bimler, Drawneek, McKim, & Schölmerich, 2004). The TAS-45 is based on 39 items from the Attachment Q-Sort (AQS; Waters, 1987), an attachment measure that has been extensively validated (van IJzendoorn, Vereijken, Bakermans-Kranenburg, & Riksen-Walraven, 2004), plus six additional items tapping atypical, affective communication. Immediately after research home visits, the research visitors sorted cards for 45 descriptive statements of child attachment behavior into five piles representing most like to least like the child. Item scores were standardized within individuals and then scaled with weights for the D hotspot. Because scores are based on standardized item scores, the possible range is large, difficult to determine, and not reported in the instrument manual. Observed range -1.511 to + .860."|Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)|ITT: all 247 children were analyzed|||units on a scale||Standard Deviation|Mean
2688562|NCT01332851|Secondary|Child Engagement/Exploration|At baseline and again at the 3-month follow-up, blinded research visitors rated the child's behavior during administration of a standardized developmental test using the Bayley Behavior Rating Scales (BRS; Bayley 1993). Engagement/exploration consists of six items rated for exploratory behavior in the testing situation (alphas = .75-.76). The items were scored on a rage of 1 to 5, the mean of the six items was computed and the possible range is 1 to 5. Higher scores indicate more engagement.|Baseline and at the 3 month follow up (~ 7 months post baseline)|ITT: all 247 children were analyzed|||units on a scale||Standard Deviation|Mean
2688563|NCT01332851|Secondary|Child Emotion Regulation|Bayley Behavior Ratings (Bayley, 1993) to assess emotion regulation. At baseline and again at the 3-month follow-up, blinded research visitors rated the child's behavior during administration of a standardized developmental test using the Bayley Behavior Rating Scales (BRS; Bayley 1993). Seven items in the BRS comprise the emotion regulation scale and capture how well the child adapts to challenging stimuli and frustration (alphas = .79-.83). Possible range is 1 - 5, the mean of seven items scored from 1 to 5. Higher scores indicate better emotional regulation.|Baseline and at the 3 month follow up (~ 7 months post baseline)|ITT: all 247 children were analyzed|||units on a scale||Standard Deviation|Mean
2688564|NCT01332851|Secondary|Child Behavior Problems|Child behavior problems (31 items; alphas =.77-.79) were measured by parent report on the Brief Infant Toddler Social and Emotional Assessment (BITSEA; Briggs-Gowan & Carter, 2002). Descriptions of positive and problematic social-emotional behaviors in the last month were rated on a 3-point scale (not true/rarely; somewhat true/sometimes; very true/often; items score 0, 1, 2 respectively). Higher score indicates more child behavior problems as noted by the parent. Possible range is 0 - 62.|Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)|ITT: all 247 children were included in the analysis.|||units on a scale||Standard Deviation|Mean
2688565|NCT01332851|Secondary|Child Social Emotional Development (Higher Scores Indicate More Competence)|Child social-emotional competence (11 items; alphas = .69-.70) was measured by the Brief Infant Toddler Social and Emotional Assessment (BITSEA; Briggs-Gowan & Carter, 2002). Possible range is 0 - 22. Parent report of child social-emotional competence in the last month were rated on a 3-point scale (not true/rarely; somewhat true/sometimes; very true/often). Higher scores indicate more competence.|Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)|ITT: All 247 children were analyzed.|||units on a scale||Standard Deviation|Mean
2688599|NCT01332435|Secondary|BPH-related Medical Costs|Medical costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).|Day 1 of a 1-day study|Enrolled Population|||United States dollars||Standard Deviation|Mean
2693861|NCT01290822|Secondary|Atrial Latency||13 minutes of testing; performed before CPB for allograft receipt|Results could not be analyzed due to poor enrollment and lack of data.||||||
2688566|NCT01332851|Secondary|Parent Stress: Competence (Higher Score Means More Stress)|At baseline, 3-month post-intervention follow-up, and 6-month post-intervention follow-up, parenting stress was measured by scales selected from the Parenting Stress Index and the Parenting Stress Index-Short Form (PSI-3, PSI-SF; Abidin, 1995). The Parenting Competence Scale from the PSI-3 (11 items) was used. Items were rated on 4-point scales (strongly agree to strongly disagree). Two items measuring parental educational attainment from the original parenting competence scale were omitted due to excessive missing data. Higher scores indicate greater parental stress associated with feelings of incompetence. Alphas ranged from .71-.94 across time points. Possible range 11 - 55, observed range 11 - 39.|Baseline 3-month post-intervention (~7 months post baseline), 6-month follow up (~ ten months post baseline)|ITT: All 247 parents were included in this analysis.|||units on a scale||Standard Deviation|Mean
2688567|NCT01332851|Secondary|Parenting Stress: Dysfunctional Interaction|Parenting stress was measured by scales selected from the Parenting Stress Index and the Parenting Stress Index-Short Form (PSI-3, PSI-SF; Abidin, 1995). The Parent-Child Dysfunctional Interaction Scale from the PSI-SF (11 items). Items were rated on 4-point scales (strongly agree to strongly disagree). Two items measuring parental educational attainment from the original parenting competence scale were omitted due to excessive missing data. Higher scores indicate greater parental stress associated with feelings of dysfunctional parent-child interactions (i.e., interactions are not reinforcing or satisfying). Alphas ranged from .71-.94 across time points. Possible range 11-55, observed range 12 to 43.|Baseline, post intervention (approximately 4 months from baseline, 3 month follow up from post intervention (~7 months from baseline), 6 month follow up (~ 10 months from baseline)|ITT: All 247 parents were included in this analysis.|||units on a scale||Standard Deviation|Mean
2688568|NCT01332851|Primary|Secure Base Behavior (Observation During Research Visit; Higher Score Indicates Greater Security)|"Secure base behavior was measured with the Toddler Attachment Sort-45 (TAS-45; Kirkland, Bimler, Drawneek, McKim, & Schölmerich, 2004). The TAS-45 is based on 39 items from the Attachment Q-Sort (AQS; Waters, 1987), an attachment measure that has been extensively validated (van IJzendoorn, Vereijken, Bakermans-Kranenburg, & Riksen-Walraven, 2004), plus six items tapping atypical affective communication. After home visits, research visitors sorted cards for 45 descriptive statements of child attachment behavior into five piles representing most like to least like the child. Item scores were standardized within individuals and then compared to a security profile to arrive at an security score. Higher value indicates greater secure base behavior. Because scores are based standardized item scores weighted by proximity to the secure profile, the possible range is large, difficult to determine, and not reported in the instrument manual. The observed range was from -.62 to +1.00."|Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)|All 247 children in the study were included|||units on a scale||Standard Deviation|Mean
2688569|NCT01332851|Primary|Parental Sensitivity (Video Recorded Observation Coded by Blind Coders)|Parent sensitivity was measured at all four time points by a modified total score of the Nursing Child Assessment Teaching Scale (NCATS; Barnard, 1994), a videotaped interaction to assess caregiver sensitivity, stimulation of the child, and emotional responsiveness during interaction were scored. The scale was modified to exclude some items from the original measure that demonstrated low variability in other studies. A total score was based on 45 items, possible range 0 - 45. Items covered mutuality (e.g. contingency, gaze, and positive affect), caregiver verbal and nonverbal support of child, and sensitive instruction during the teaching task. Items were scored yes (1) or no (0), and yes scores were summed. Cronbach's alpha for the sensitivity scale ranged from .68 to .72. A single, blinded coder was trained to reliability by a certified NCATS instructor and passed regular reliability checks. Higher scores indicate greater parental sensitivity.|Baseline, post intervention (approximately 4 months from baseline, 3 month follow up (~7 months from baseline), 6 month follow up (~ 10 months from baseline)|ITT, all 247 parents were coded on the sensitivity measure and were analyzed.|||units on a scale||Standard Deviation|Mean
2688570|NCT01332851|Primary|Child Welfare Outcomes: CWS Removal From Birth Parent Home|Official child welfare administrative records indicating whether child was removed from the birth parent home within one year of parent completing intervention (or one year after estimated date intervention would have been completed, for parents who did not complete). Data were analyzed with a survival model that predicted hazard of being removed from the birth parent home.|1 year post intervention||||participants|||Number
2688571|NCT01332799|Secondary|Arterial Stiffness|Changes in pulse wave velocity.|3 years|No intervention occurred, so no data was collected for report.||||||
2688572|NCT01332799|Primary|Endothelial Function|Changes in flow-mediated dilatation of braquial artery.|3 years|No intervention occurred, so no data was collected for report.||||||
2688573|NCT01332799|Primary|Cardiovascular Events|Number of major cardiovascular events|3 years|No intervention occurred, so no data was collected for report.||||||
2688574|NCT01332721|Secondary|Objective Response According to RECIST 1.1|The best response according to RECIST 1.1 for each patient with measurable disease and who received at least one dose of study drug will be listed by cohort and tumor type|1.5 years||||participants|||Number
2688575|NCT01332721|Secondary|Immune Response to TRC105|HAMA and HACA titers will be measured at specified time-points.|1.5 years||||participants|||Number
2688576|NCT01332721|Secondary|TRC105 Pharmacokinetic Concentrations|Plasma TRC105 concentrations will be measured at specified timepoints.|1.5 years|||||||
2688577|NCT01332721|Primary|Determine Maximum Tolerated Dose of TRC105 in Combination With Bevacizumab|Three patients will be initially enrolled and treated at each dose level. If none of these 3 patients experiences a dose-limiting toxicity (DLT) during the 28-day evaluation period, dose escalation will proceed following review of safety data with appropriate site staff including the principal investigators at all sites. If 1 of 3 patients experiences DLT, the cohort will be expanded to 6 patients. The maximum tolerated dose (MTD) will have been exceeded if ≥ 33% of patients experience DLT in a given cohort. DLT will have occurred when a patient has 1 or more toxicity listed in the table below that is at least possibly related to the combination of bevacizumab and TRC105 during the first 28 days (cycle 1).|1.5 years||||mg/kg|||Number
2688578|NCT01332630|Primary|Overall Response Rate (ORR)|"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."|8-24 weeks||||Participants|||Count of Participants
2688580|NCT01332578|Secondary|Time to Completion of Gastric Emptying|Time to completion of gastric emptying of hot drink remedy and standard paracetamol tablets was assessed using Gamma Scintigraphy images and WebLink image analysis program. Completion of gastric emptying was confirmed by two consecutive images with negligible gastric activity.|Baseline to 10 hours|Period Level MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in one of the two study periods. Gastric emptying endpoints were only measured in the first period for each participant.|||minutes||Standard Error|Least Squares Mean
2688581|NCT01332578|Secondary|Time to Onset of Gastric Emptying|The individual anterior and posterior images were assessed using Gamma Scintigraphy images and WebLink Image Analysis program to determine the time to onset of gastric emptying of hot drink remedy and standard paracetamol tablets.|Baseline to 10 hours|Period Level MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in one of the two study periods. Gastric emptying endpoints were only measured in the first period for each participant.|||minutes||Standard Error|Least Squares Mean
2688582|NCT01332578|Secondary|Time to Maximum Plasma Concentration (Tmax)|Time after administration when the maximum plasma concentration was reached.|Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.|||hours||Full Range|Median
2688583|NCT01332578|Secondary|Maximum Plasma Concentration (Cmax)|Cmax was determined using plasma paracetamol concentration time profile.|Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.|||ng/mL||Standard Deviation|Mean
2688584|NCT01332578|Secondary|AUC (0-60 Min)|AUC (0-60 min) was determined from paracetamol plasma concentration time profiles using trapezoidal method.|Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.|||ng*h/mL||Standard Deviation|Mean
2688585|NCT01332578|Secondary|Area Under the Concentration/Time Curve From 0 to 30 Minutes (Min) (AUC 0-30 Min)|AUC (0-30 min) was determined from paracetamol plasma concentration time profiles using trapezoidal rule.|Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|MITT population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.|||nanograms (ng)*hours (h)/mL||Standard Deviation|Mean
2688586|NCT01332578|Primary|Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter)|Time to reach plasma paracetamol concentration of 0.25 μg/mL was determined using plasma concentration time profiles.|Blood samples taken within 15-30 minutes prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose|Modified Intent-To-Treat (MITT) population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.|||minutes||Full Range|Median
2688587|NCT01332500|Primary|Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis|Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). .Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories.|6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.|||United States dollars||Standard Deviation|Mean
2688588|NCT01332500|Primary|Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis|Health Pan Cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories.|6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.|||United States dollars||Standard Deviation|Mean
2688589|NCT01332500|Primary|Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis|"The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. Other represents APAP/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the quantity dispensed field in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans)."|6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.|||tablets per participant||Standard Deviation|Mean
2688600|NCT01332435|Secondary|Total BPH-related Costs|All costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).|Day 1 of a 1-day study|Enrolled Population|||United States dollars||Standard Deviation|Mean
2688601|NCT01332435|Primary|Number of Participants Who Needed Prostate-Related Surgery|Prostate-related surgery was identified by relevant CPT procedure codes and ICD-9CM diagnosis codes.|Day 1 of a 1-day study|Enrolled Population|||participants|||Number
2688590|NCT01332500|Primary|Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis|Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories.|6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.|||United States dollars||Standard Deviation|Mean
2688591|NCT01332500|Primary|Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis|Health plan cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories.|6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.|||United States dollars||Standard Deviation|Mean
2688592|NCT01332500|Primary|Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis|"The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. Other represents acetaminophen (APAP)/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the quantity dispensed field in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans)."|6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)|The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.|||tablets per participant||Standard Deviation|Mean
2688593|NCT01332487|Secondary|Number of Participants With the Indicated Time Between Acute Urinary Retention and Subsequent Surgery||6 months|Male participants age 50 years and older with a diagnosis of benign prostatic hyperplasia (BPH) or enlarged prostate (EP). Only those participants who were treated with surgery within 182 days of the first prescription of 5ARI were analyzed.|||participants|||Number
2688594|NCT01332487|Primary|Number of Participants Who Experienced Progression of Disease|The number of participants in each study group with a treatment code for acute urinary retention, surgery, or emergency surgery (defined as surgery within 30 days following a diagnosis of acute urinary retention) was measured.|Up to 5 months|Male participants age 50 years and older with a diagnosis of benign prostatic hyperplasia (BPH) or enlarged prostate (EP)|||participants|||Number
2688595|NCT01332461|Secondary|Mean Monthly COPD-related Costs Per Participant|Cost categories included medical, pharmacy, and total calculated as the sum of medical and pharmacy. Costs were computed during a variable follow-up period and were standardized on a per-month basis. COPD-related medical costs were computed using claims with a primary diagnosis of COPD, and COPD-related pharmacy costs were computed using the paid amounts of pharmacy claims for prescription medication used for COPD.|Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)|Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge|||United States (US) dollars||Standard Deviation|Mean
2688596|NCT01332461|Secondary|Number of Participants Having a COPD-related Event Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years|The number of participants having a COPD-related event was computed during the follow-up and was standardized by dividing by the total days of follow-up in each cohort since patients had different lengths of follow-up. Four types of COPD events were defined: COPD-related hospitalization, emergency room (ER) visit, physician visit with a prescription (Rx) for oral corticosteroid or antibiotic within 3 days of the visit, or combined occurrence of any of the aforementioned three types.|Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)|Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge|||participants per 100 person-years|||Number
2688597|NCT01332461|Primary|Number of Participants Having a Hospitalization or Emergency Room (ER) Visit Related to Chronic Obstructive Pulmonary Disease (COPD) Represented Per 100 Person-years|The number of participants (par.) with a COPD-related hospitalization/ ER visit was computed during follow-up (FU) and was standardized by dividing by the total days of FU in each cohort since par. had different lengths of FU. The number of par. per 100 person-years was computed as: numerator = total number of par. with a COPD-related hospitalization/ER visit; denominator = sum of the time of FU in years across all par./100. The index date is defined as the date of discharge from a hospitalization/ER visit for COPD that had a maintenance medication dispensed within 60 days post-discharge.|Maximum of 1 year after index date (Jan 1, 2004 through May 30, 2008)|Managed care enrollees with at least 1 inpatient hospitalization (IP) with primary or secondary diagnosis of COPD (International Classification of Disease (ICD) code 491.xx, 492.xx, and 496.xx) or at least one ER visit with primary diagnosis of COPD during the study period with maintenance medication within 60 days post-discharge|||participants per 100 person-years|||Number
2688598|NCT01332435|Secondary|BPH-related Pharmacy Costs|Pharmacy costs related to BPH were defined by claims costs associated with a ICD-9CM diagnosis code for BPH (222.2, 600.xx).|Day 1 of a 1-day study|Enrolled Population|||United States dollars||Standard Deviation|Mean
2710805|NCT01167829|Secondary|Mean Dihydrotestosterone (DHT) Concentration||baseline & day 9|per protocol|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
2688603|NCT01332435|Primary|Number of Participants With Clinical Progression|Clinical progression was identified as the occurrence of acute urinary retention and/or surgery as identified by relevant Common Procedure Terminology (CPT) procedure codes and International Classification of Diseases (ICD)-9CM diagnosis codes.|Day 1 of a 1-day study|Enrolled Population: Men aged >=50 years old between 7/1/2000 and 12/31/2006 with a diagnosis of benign prostatic hyperplasia and who were treated with an AB and concomitant 5-ARI therapy within 6 months of starting AB therapy|||participants|||Number
2688604|NCT01332357|Primary|Number of Participants With an Asthma-related Event Occurring Between 1 and 6 Months Following the Index Event|A subsequent asthma-related inpatient (IP) visit or emergency department (ED) visit were defined as visits within 6 months of the index event. The index event was defined as an asthma-related hospitalization or ED visit occuring between 2004 and 2008.|Data were collected during a 4-year period from January 1, 2004 to December 31, 2008.|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.|||participants|||Number
2688605|NCT01332331|Secondary|Ratio to Baseline in Plasma N-terminal Pro-B Type Natriuretic Peptide (NT-Pro BNP) Concentration at Week 24|NT-Pro BNP plasma concentrations were determined at specific time points. Geometric mean and SD logs has been presented. Day 1 was considered as Baseline. Ratio to Baseline is expressed as percentage change from Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline, Week 12 and 24|Intent-to-treat population. Only those participants with available data at the specified time points were analyzed.|||Percentage Change||Standard Deviation|Geometric Mean
2688606|NCT01332331|Secondary|Change From Baseline in World Health Organization (WHO) Functional Class to Week 24|PAH was classified by WHO functional class (FC) at specific time points. There were four WHO FC grades based on severity of PAH symptoms (Class I=none, Class IV=most severe). Grades were then mapped to numeric scale, for which scores ranged from 1 to 4 (Class I=1 and Class IV=4). Score at Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline, Week 4, 8, 12, 16, 20 and 24|Intent-to-treat population. Only those participants with available data at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2688607|NCT01332331|Secondary|Change From Baseline in Subject Global Assessment to Week 24 Using the SF-10 Health Survey for Children|Short-form 10 (SF-10) Health Survey for Children is a 10-item parent-completed health assessment that measures physical and psychosocial functioning for children ages five and over. Each item has either 4, 5 or 6 response choices with associated point systems. Two summary scores were calculated: a Physical Summary Score (PHS) and a Psychosocial Summary Score (PSS) with a range of 5 to 30 points for each 5-item score. This aggregated point score was then standardized and transformed to a norm-based scoring metric in accordance with the developer's algorithms using associated mean and standard deviation derived from 2006 sample data. This generated the final standardized norm-based scores for PHS (range -10.90 to 57.21) and for PSS (range 8.81 to 62.28), respectively. A higher value on each summary score indicates better functioning. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline and Week 24|Intent-to-treat population. Only those participants with available data at the specified time points were analyzed.|||Scores on a scale||Standard Deviation|Mean
2688608|NCT01332331|Secondary|Time to the First Clinical Worsening of Pulmonary Arterial Hypertension (PAH)|Time to clinical worsening of PAH is defined as the time from randomization to the first occurrence of death or placed for lung transplant, hospitalization due to PAH deterioration, addition or increased dose of other targeted PAH therapeutic agents like prostanoids and PDE-5 inhibitors) and/or atrial septostomy, other PAH related deterioration identified by increase in WHO functional class, deterioration in exercise testing and clinical signs or symptoms of right sided heart failure.|Up to Week 24|Intent-to-treat population. Only those participants with available data at the specified time points were analyzed.|||Days||Standard Deviation|Mean
2688609|NCT01332331|Secondary|Change From Baseline in the 6 Minutes Walking Distance (6MWD) Test|Participant's 6MWD data has been presented into three categories as overall, with oxygen use and without oxygen use. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. NA indicates that standard deviation could not be calculated for single participant. Intent-to-Treat (ITT) population consist of all randomized participants who received at least one dose of study drug.|Baseline, Weeks 4, 8, 12, 16, 20 and 24|Intent-to-treat population. Only those participants with available data at the specified time points were analyzed.|||Meters||Standard Deviation|Mean
2688610|NCT01332331|Primary|Change From Baseline in Plasma Endocrine Parameter - Female : Sex Hormone Binding Globulin at Weeks 12 and 24|Sex hormone binding globulin level of participants were measured. Only those parameters having status - overall were presented. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline, Week 12 and 24|Safety population. Only those female participants with available data at the specified time points were analyzed.|||Milliliter||Standard Deviation|Mean
2688611|NCT01332331|Primary|Change From Baseline in Plasma Endocrine Parameter - Female : Inhibin B at Weeks 12 and 24|Inhibin B level of participants were measured. Only those parameters having status - overall were presented. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline, Week 12 and 24|Safety population. Only those female participants with available data at the specified time points were analyzed.|||Nanogram per liter||Standard Deviation|Mean
2688612|NCT01332331|Primary|Change From Baseline in Plasma Endocrine Parameter - Female : Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) at Weeks 12 and 24|FSH and LH level of participants were measured. Only those parameters having status - overall were presented. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline, Week 12 and 24|Safety population. Only those female participants with available data at the specified time points were analyzed.|||International unit per Liter||Standard Deviation|Mean
2688718|NCT01332188|Secondary|Rhinorrhea at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688613|NCT01332331|Primary|Change From Baseline of Pubertal Development: Men- Testicular Volume (TV) at Weeks 12 and 24|Testicular volume was assessed by Prader's orchiodometer and the assessment was performed by a pediatric endocrinologist using the Tanner's criteria. Only those parameters having status - overall were presented. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.|Baseline, Week 12 and 24|Safety population. Only those male participants with available data at the specified time points were analyzed.|||Milliliter||Standard Deviation|Mean
2688614|NCT01332331|Primary|Number of Participants With Post Baseline PCI Value for Vital Signs Parameter: Weight|Weight of the participants was measured. PCI ranges were <20 kilogram (kg) for weight. Only those parameters having any time post-Baseline PCI values were presented. Day 1 was considered as Baseline.|Up to 24 Weeks|Safety population|||Participants|||Count of Participants
2688615|NCT01332331|Primary|Number of Participants With Post Baseline PCI Value for Vital Signs Parameter: Heart Rate|Heart rate was measured in semi-supine position after 5 minutes rest for the participants at indicated time points. PCI ranges were <50 to >120 beats per minute (beats/min). Only those parameters having any time post-Baseline PCI values were presented. Day 1 was considered as Baseline.|Up to 24 Weeks|Safety population|||Participants|||Count of Participants
2688616|NCT01332331|Primary|Number of Participants With Post Baseline PCI Value for Vital Signs Parameter: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|SBP and DBP were measured in semi-supine position after 5 minutes rest for the participants at indicated time points. PCI ranges were <80 to >160 millimeters of mercury (mmHg) for SDP and <40 to >110 mmHg for DBP. Only those parameters having any time post-Baseline PCI values were presented. Day 1 was considered as Baseline.|Up to 24 Weeks|Safety population|||Participants|||Count of Participants
2688617|NCT01332331|Primary|Percentage of Physical Examination Parameter: Saturated Oxygen Level|Physical examination of participants saturated oxygen level was measured. Day 1 was considered as Baseline.|Week 12 and 24|Safety population. Only those participants with available data at the specified time points were analyzed.|||Percentage of oxygen saturation||Standard Deviation|Mean
2688618|NCT01332331|Primary|Number of Participants With Abnormal Value for Physical Examination Parameter: Ascites|Physcial examination of paricipants ascites was measured. Day 1 was considered as Baseline.|Week 12 and 24|Safety population. Only those participants with available data at the specified time points were analyzed.|||Participants|||Count of Participants
2688619|NCT01332331|Primary|Number of Participants With Abnormal Value for Physical Examination Parameter: Peripheral Edema|Physical examination of paricipants peripheral edema is measured. Day 1 was considered as Baseline.|Week 12 and 24|Safety population. Only those participants with available data at the specified time points were analyzed.|||Participants|||Count of Participants
2688620|NCT01332331|Primary|Number of Participants With Abnormal Value for Physical Examination Parameter: Jugular Venous Pressure|Physical examination of participants jugular venous pressure is measured.|Week 12 and 24|Safety population. Only those participants with available data at the specified time points were analyzed.|||Participants|||Count of Participants
2688621|NCT01332331|Primary|Number of Participants With Abnormal Value for Physical Examination Parameter: Liver Size|Physical examination included measurement of liver size. Any abnormal enlargement or reduction in the size of the liver is reported.|Week 12 and 24|Safety population. Only those participants with available data at the specified time points were analyzed.|||Participants|||Count of Participants
2688622|NCT01332331|Primary|Number of Participants With Post Baseline PCI Value for Hematology Parameter: Platelet Count|Blood samples were collected from participants for analysis of following hematology parameter: platelet count. PCI ranges were 100 to 400 for Giga cells per liter platelet count. Only those parameters having any time post-Baseline PCI values were presented. Day 1 was considered as Baseline.|Up to 24 Weeks|Safety population|||Participants|||Count of Participants
2688623|NCT01332331|Primary|Number of Participants With Post Baseline PCI Value for Hematology Parameter: Hematocrit|Blood samples were collected from participants for analysis of following hematology parameter: hematocrit. PCI ranges were males: <0.32 to >0.54, females: <0.29 to >0.506 proportion of red blood cells in blood for hematocrit. Only those parameters having any time post-Baseline PCI values were presented. Day 1 was considered as Baseline.|Up to 24 Weeks|Safety population|||Participants|||Count of Participants
2688624|NCT01332331|Primary|Number of Participants With Post Baseline PCI Value for Hematology Parameter: Hemoglobin|Blood samples were collected from participants for analysis of following hematology parameters: hemoglobin. PCI ranges were Males: 98 to180 grams per liter (G/L), Females: 91 to 161 (G/L) for hemoglobin. Only those parameters having any time post-Baseline PCI values were presented. Day 1 was considered as Baseline.|Up to 24 Weeks|Safety population|||Participants|||Count of Participants
2688625|NCT01332331|Primary|Number of Participants With Post Baseline Potential Clinical Importance (PCI) Value for Clinical Chemistry Parameters: Alanine Amino Transferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT), Total Bilirubin and Creatinine|Blood samples were collected from participants for analysis of following clinical chemistry parameters: ALT, AST, GGT, total bilirubin and creatinine. PCI ranges were <3 times the upper limit of normal (ULN), <34.2 Micromoles per liter (UMOL/L) for total bilirubin and <176.8 (UMOL/L) for creatinine. Only those parameters having any time post-Baseline PCI values were presented. Day 1 was considered as Baseline.|Up to 24 Weeks|Safety Population|||Participants|||Count of Participants
2688626|NCT01332331|Primary|Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Treatment-emergent Adverse Events (SAEs)|AEs defined as any untoward medical occurrence in a patient or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAEs defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect, medical events that may not immediately life threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention as per medical or scientific judgement and events of drug-induced liver injury with hyperbilirubinaemia. Safety population comprised of all randomized participants who received at least 1 dose of study drug.|Up to 24 Weeks|Safety Population|||Participants|||Count of Participants
2710806|NCT01167829|Secondary|Maximum Dihydrotestosterone (DHT) Concentration||baseline & day 9|per protocol|||ng/dL||Geometric Coefficient of Variation|Geometric Mean
2688627|NCT01332318|Secondary|Mean Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Pittsburgh Sleep Diary (PghSD) Sleep Quality|"The PghSD assessed a participant's previous night's sleep. Sleep quality was assessed using a Visual Analogue Scale (VAS). Participants indicated their sleep quality by marking a vertical line on a horizontal scale anchored by responses very bad and very good. VAS score was determined by measuring the distance in millimeters (mm) from the left hand end of the line to the point that the participant marked. Scores ranged from 0 to 100 mm with higher scores indicating better sleep quality and lower scores indicating worse sleep quality."|Baseline (Day -1and 1) and Days 14, 15, and 16|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group. The number of participants assessed for each PghSD question at each study day varies due to incomplete/missing data."|||millimeters||Standard Deviation|Mean
2688628|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Pittsburgh Sleep Diary (PghSD) Total Sleep Time Item|The PghSD assessed a participant's previous night's sleep. Change from baseline was calculated as the Day 14 (in the evening), 15 (in the morning after dose), and 16 (at Tmax)value minus the Baseline (Days -1 and 1) value. Total sleep time is expressed in hours.|Baseline (Days -1 and 1) and Days 14, 15, and 16|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group. The number of participants assessed for each PghSD question at each study day varies due to incomplete/missing data."|||hours||Standard Deviation|Mean
2688629|NCT01332318|Secondary|Mean Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Pittsburgh Sleep Diary (PghSD) Sleep Onset Items|The PghSD assessed participant's previous night's sleep. Change from baseline was calculated as the Day 14 (in the evening), 15 (in the morning), and 16 (at Tmax of GEn and DPH) value minus the Baseline (Days -1 and 1) value. Latency to sleep onset (time to fall asleep) and wake time after sleep onset are expressed in minutes.|Baseline (Days -1and 1) and Days 14, 15, and 16|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group. The number of participants assessed for each PghSD question at each study day varies due to incomplete/missing data."|||minutes||Standard Deviation|Mean
2688630|NCT01332318|Secondary|Number of Participants With the Indicated Post Sleep Questionnaire (PSQ) Responses at Day 14|The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep.|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."|||participants|||Number
2688631|NCT01332318|Secondary|Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Day 14|The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-minute increments. The period was divided into 7 four-hour intervals (8 AM to 12 PM, 12 PM to 4 PM, 4 PM to 8 PM, 6 PM to 10 PM, 8 PM to 12 Midnight, Midnight to 4 AM, and 4 AM to 8 AM).|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."|||participants|||Number
2688632|NCT01332318|Secondary|Percentage of Participants With no Reported RLS Symptoms During the 24-hour RLS Record at Day 14|The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-min increments beginning at 8AM on the day prior to the visit.|Day 14|Modified Intent-to-Treat (MITT) Population. Participants in the|||percentage of participants|||Number
2688633|NCT01332318|Secondary|Median Time to Onset of a Participant's First RLS Symptoms Using the 24-hour RLS Symptom Record at Day 14|The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-min increments beginning at 8AM on the day prior to the visit. For Arms 2 and 3, upper limits of the confidence intervals are not available, as they are beyond the 24-hour time frame.|Day 14|Modified Intent-to-Treat (MITT) Population. Participants in the|||participants||95% Confidence Interval|Median
2688634|NCT01332318|Secondary|Number of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Day 14|"The participant-rated CGI-I is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being very much improved, and a score of 7 being very much worse. Response was defined as a rating of very much improved or much improved (score of 1 or 2 on the scale)."|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."|||participants|||Number
2688635|NCT01332318|Secondary|Number of Participants in Each Category of the Participant-Rated Clinician Global Impression of Improvement (CGI-I) Scale at Day 14|"The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being very much improved and a score of 7 being very much worse."|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."|||participants|||Number
2688636|NCT01332318|Secondary|Number of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated CGI-I at Day 14|"The investigator-rated CGI-I is a clinician-rated assessment designed to allow clinicians to rate the change of their participant's disease severity over time based on a seven-point scale, with a score of 1 being very much improved, and a score of 7 being very much worse compared to baseline. For this endpoint, response was defined as a rating of very much improved or much improved (score of 1 or 2 on the scale) compared to baseline."|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."|||participants|||Number
2688637|NCT01332318|Secondary|Number of Participants in Each Category of the Investigator-Rated Clinician Global Impression of Improvement (CGI-I) Scale at Day 14|"The CGI scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change of the disease severity over time based on a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to baseline."|Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."|||participants|||Number
2688638|NCT01332318|Secondary|Mean Change From Baseline (Day -1) at Day 14 in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score|The IRLS Rating scale is a measure of RLS disease severity and reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement.|Baseline (Day -1) and Day 14|"Modified Intent-to-Treat (MITT) Population. Participants in the GEn placebo and DPH placebo and the GEn placebo and DPH 50 mg on Day 16 arms have been combined into the GEn placebo and DPH group."|||scores on a scale||Standard Deviation|Mean
2688639|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Tower of London (TOL) Score|Participants (par.) were asked to look at 2 pictures simultaneously; each picture showed 3 different colored balls arranged on 3 pegs. Par. were to estimate the number of times the balls in 1 picture would have to be moved to make the arrangement of balls identical to that of the second picture. Par. were allowed 20 seconds to respond to each pair of pictures. The number of correct items was the TOL Score (range: 0-22). The TOL scaled test score was calculated as indicated for the Verbal Memory Test. The scaled test score range is -7.53 to 2.76; higher scaled scores indicate better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
2688640|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Symbol Coding Test Score|Participants were given a list of numbers (numerals 1-9) that were each associated with a unique symbol. Participants decoded a list of 110 symbols as quickly as possible in 90 seconds. The total number of symbols correctly decoded was the Symbol Coding Score (range: 0-110). The Symbol Coding scaled test score was calculated as indicated for the Verbal Memory Test. Change from baseline was calculated as the Day composite score minus the Baseline composite score. The scaled test score range is -7 to 10.08, with higher scaled scores indicating better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
2688641|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Verbal Fluency Test Score|Verbal Fluency included one semantic fluency and two letter fluency tasks. Participants were given 60 seconds to name as many words as possible within a given semantic category (supermarket items), and in two separate trials, participants were given 60 seconds to generate as many words as possible that began with a given letter. The total number of words from all of the 3 trials was the Verbal Fluency score (range: 0-150). The scaled test score was calculated as indicated for the Verbal Memory Test. The scaled test score range is -5 to 10.83; higher scaled scores indicate better cognition.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
2688642|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Token Motor Task Test Score|Participants were given 100 plastic tokens and asked to place them in a container, 2 at a time, as quickly as possible for 60 seconds. The number of tokens correctly placed in the container was the Token Motor Task score (range: 0-100). The BAC was conducted prior to each simulated driving test. The Token Motor Task scaled test score was calculated as indicated for the Verbal Memory Test. Change from baseline was calculated as the Day composite score minus the Baseline composite score. The scaled test score range is -6.95 to 3.35, with higher scaled scores indicating better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
2688643|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Digit Sequencing Score (DSS)|Participants (par.) were presented with sets of numbers of increasing length and asked to tell the experimenter the numbers in order from lowest to highest. The task has 7 levels; the first level had 2 digits in the set (e.g., 5, 2); the second level had 3 digits in the set, etc. The number of times the par. correctly arranged the numbers was recorded as the score for each level. The DSS is the sum of the 7 level scores (range: 0-28). The scaled test score was calculated as indicated for the Verbal Memory Test and ranges from -6.68 to 2.73; higher scaled scores indicate better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
2688653|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Lane Position Variability (LPV)|Lane position variability (LPV) was defined as the standard deviation of lane position, and was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall LPV was calculated as the Day 14 (in the evening) or Day 15 (in the morning after GEn dosed at 5 PM) mean LPV over the 1-hour drive minus the Baseline (Day -1 or Day 1) mean LPV over the 1-hour drive.|Baseline (Days -1 and 1) and Days 14 and 15|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||feet||Standard Deviation|Mean
2688644|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Verbal Memory Test Score|Participants were presented with 15 words and asked to recall as many as possible; the procedure was repeated 5 times. The total number of words recalled correctly across the 5 administrations of the list was the participant's Verbal Memory Recall score (range: 0-75). The scaled test score was calculated as ((BAC component raw test score - healthy control sample test mean)/healthy control sample test standard deviation); a healthy control sample was matched to the participant's sex and age category. The scaled test score range is -7.37 to 4.86; higher scaled scores indicate better cognition.|Baseline (Days -1and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
2688645|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Composite Score|The BAC was designed as a comprehensive measure of cognitive function, including 6 individual tests: Verbal Memory Recall, Digit Sequencing, Token Motor Task, Verbal Fluency, Symbol Coding, and Tower of London. The composite/total BAC score is calculated by scoring each individual test, comparing each score to a healthy control sample (matched for sex and age category) to create z-scores, summing the z-scores, and rescaling the sum. The composite score range is -2127.8 to 1878.8, with higher scores indicating better cognition.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||scores on a scale||Standard Deviation|Mean
2688646|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) in the Epworth Sleepiness Scale (ESS) Total Score|"The Epworth Sleepiness Scale (ESS) is a questionnaire designed to evaluate daytime sleepiness. Participants were asked to rate how likely they were to doze or fall asleep during 8 activities on a scale of 0 (would never do) to 3 (high chance of dozing). The total score ranges from 0-24, with a score greater than 10 representing excessive daytime sleepiness (an increased chance of dozing). Change from baseline was calculated as the Day 14 total score minus the Baseline total score."|Baseline (Day -1) and Day 14|Modified Intent-to-Treat (MITT) Population|||scores on a scale||Standard Deviation|Mean
2688647|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Alertness Visual Analog Scale (VAS) Score|"Alertness VAS was completed immediately before and after each simulated driving assessment. Participants indicated their alertness by marking a vertical line on a horizontal scale anchored by responses extremely sleepy and extremely alert. VAS score was determined by measuring the distance in millimeters (mm) from the left hand end of the line to the point the participant marked. Scores ranged from 0-100 mm, with higher scores indicating more alertness and lower scores indicating more sleepiness. Change score was calculated as the Day 14, 15, or 16 VAS score minus the Baseline VAS score."|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. Varying numbers of participants did not complete either the pre- or post-drive VAS at either Baseline or the day of assessment; as such, the number of participants analyzed varies by day.|||millimeters||Standard Deviation|Mean
2688648|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Brake Reaction Time|Brake reaction time was assessed as the time it took for each participant to move their foot off the accelerator and onto the brake pedal after the appearance of a stop sign on the simulation screen. Change from baseline was calculated as the Day 14, 15, or 16 mean reaction time minus the Baseline (Days -1 and 1) mean reaction time.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||seconds||Standard Deviation|Mean
2688649|NCT01332318|Secondary|Number of Participants With the Indicated Number of Simulated Crashes on Days 14 (Evening), 15 (Morning After Dose), and 16 (Tmax)|A simulated crash was defined as a collision with an oncoming car or obstacle (e.g., tree) or when the distance to the center line was greater than 18 feet on either side of the road.|Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||participants|||Number
2688650|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Average Speed|Participants were instructed to maintain a speed of 55 miles per hour during the driving assessment. Change from baseline in overall average speed was calculated as the Day 14 (in the evening), 15 (in the morning), or 16 (at Tmax of GEn and DPH) mean speed over the 1-hour drive minus the Baseline (Days -1 and 1) mean speed over the 1-hour drive.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||miles per hour||Standard Deviation|Mean
2688651|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Speed Variability|Speed variability was defined as the standard deviation of the speed (measured in miles per hour). Participants were instructed to maintain a speed of 55 miles per hour during the test drive. Change from baseline in overall speed variability was calculated as the Day 14 (in the evening), 15 (in the morning), or 16 (at Tmax of GEn and DPH) mean speed variability over the 1-hour drive minus the Baseline (Days -1 and 1) mean speed variability over the 1-hour drive.|Baseline (Day -1) and Days 14 and 16; baseline (Day 1) and Day 15|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||miles per hour||Standard Deviation|Mean
2688652|NCT01332318|Secondary|Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Average Lane Position|Lane position was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall average lane position was calculated as the Day 14 (in the evening), 15 (in the morning after GEn dosed at 5 PM), or 16 (assessment at Tmax of GEn and DPH) mean lane position over the 1-hour drive minus the Baseline (Days -1 and 1) mean lane position over the 1-hour drive.|Baseline (Days -1 and 1) and Days 14, 15, and 16|Modified Intent-to-Treat (MITT) Population. The number of participants assessed at each study day varies due to incomplete/missing data.|||feet||Standard Deviation|Mean
2688654|NCT01332318|Primary|Change From Baseline (Day -1) in Overall Lane Position Variability (LPV) on Day 16 (Tmax)|Lane position variability (LPV) was defined as the standard deviation of lane position, and was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall LPV was calculated as the Day 16 mean LPV over the 1-hour drive minus the Baseline mean LPV over the 1-hour drive. The Day 16 measurement is at the time of maximum concentration (Tmax) for both GEn and DPH.|Baseline (Day -1) and Day 16|Modified Intent-to-Treat (MITT) Population: all participants in the Safety Population who completed at least one Baseline and one End of Study (Days 14-16) simulated driving assessment. The number of participants assessed at each study day varies due to incomplete/missing data.|||feet||Standard Error|Least Squares Mean
2688655|NCT01332305|Primary|Mean AUCss|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUCss is the area under the curve during the steady-state period. The AUCss is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. AUCss used concentration data from 0 to 24 hours at steady-state for Weeks 4 and 12.|Weeks 4 and 12|Safety Population. Placebo participants were not included in the PK assessments, as they had no exposure to GEn. Of participants who completed the study, some were not included at Week 12 (sample not taken or below limit of quantitation).|||ng*hour/ml||Standard Deviation|Mean
2688656|NCT01332305|Primary|Mean Tmax and T1/2|"Tmax is defined as the time to the maximum or peak concentration of a drug observed after multiple administration. T1/2 is defined as the time to when half of the total amount of a particular substance is eliminated from the body."|Weeks 4 and 12|Safety Population. Placebo participants (par.) were not included in the PK assessments, as they had no exposure to GEn. At W4, there were two par. excluded from the T1/2, as a result of no sample taken or a PK profile not possible. Of par. who completed the study, some were not included at W12 (sample not taken or below limit of quantitation).|||hours||Standard Deviation|Mean
2688657|NCT01332305|Primary|Mean Css, Max and Css, Min|"Css, max is defined as the maximum or peak concentration of a drug observed after multiple administration, at steady state. Css, max is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. Css, min is defined as the minimum concentration of a drug observed after its administration, in steady state. ng, nanograms; PK, pharmacokinetic; W, week; BLQ, below limit of quantitation."|Weeks 4 and 12|Safety Population: all participants (par.) who were randomized and received at least one (or any portion of a) dose of study drug. Population was analyzed as randomized. Placebo par. had no exposure to GEn and were not included in the PK assessments. Of par. who completed the study, some were not included at W12 (sample not taken or BLQ).|||nanograms per milliliter (ng/ml)||Standard Deviation|Mean
2688658|NCT01332292|Primary|Change From Baseline in the Indicated Electrocardiographic (ECG) Parameters at the Indicated Time Points on Day 14 of the Respective Treatment Period|PR, QRS, QT, QTcB, QTcF, and RR were measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period. Change from Baseline was calculated as the value at Day 14 minus the Baseline value. QTcB is the QT duration corrected for heart rate by Bazett's formula. QTcF is the QT duration corrected for heart rate by Fridericia's formula.|Baseline and Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||milliseconds (msec)||Standard Deviation|Mean
2688659|NCT01332292|Secondary|Ex-throat Dose (ETD) and ETD <2 Microns on Days 1 and 14 of the Respective Treatment Period|"The ex-throat dose (ETD) and the nominal ETD is the mass (micrograms) of active investigational material that passes beyond the throat, nominal being the mean.The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted ETD and ETD <2 microns."|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||micrograms||Standard Deviation|Mean
2688660|NCT01332292|Secondary|Total Emitted Dose (TED) on Days 1 and 14 of the Respective Treatment Period|The total emitted dose (TED) is defined as the mass (micrograms) of the nominal dose that passes beyond the throat. The recorded inhalation profiles of the participants and the mouth-throat (oropharyngeal) models of the sizes that approximated to pharyngometry measurements of the participants were used in conjunction with the electronic Lung (eLung) for in vitro assessment. The eLung is a breathing simulator that replicates the selected inhalation profile with an active inhaler placed at the lips end of the selected ororpharyngeal model. After the dose is emitted from the inhaler, the analysis and assay of throat deposition and material passing beyond the throat was used to derive the nominal, minimum, and maximum predicted total emitted dose.|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||micrograms||Standard Deviation|Mean
2688677|NCT01332292|Primary|Albumin and Total Protein Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of albumin and total protein at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter||Standard Deviation|Mean
2700352|NCT01243320|Primary|Change In Alanine Aminotransferase Blood Level|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||u/L||95% Confidence Interval|Mean
2688661|NCT01332292|Secondary|Peak Pressure Drop on Days 1 and 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Peak pressure drop is defined as the maximum pressure drop (kilopascal [kPa]) achieved during inhalation across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was calculated for each day (Days 1 and 14 of the respective treatment period), and used for subsequent modeling and prediction of dose emission attributes.|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Kilopascal (kpa)||Standard Deviation|Mean
2688662|NCT01332292|Secondary|Inhaled Volume on Days 1 and 14 of the Respective Treatment Period|"During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhaled volume is defined as the volume of air (Liters) inhaled during the inhalation across the resistance of the inhaler.~The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalaled volume was determined."|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters||Standard Deviation|Mean
2688663|NCT01332292|Secondary|Inhalation Time on Days 1 and 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Inhalation time is defined as the duration of the inhalation(s) when inhaling across the resistance of the inhaler. The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the inhalation time was determined.|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Seconds||Standard Deviation|Mean
2688664|NCT01332292|Secondary|Average Flow Rate and Peak Inspiratory Flow Rate (PIFR) on Days 1 and 14 of the Respective Treatment Period|During the inhalation profile assessment, participants inhaled through a mouthpiece from a device with a similar resistance to the dry powder inhaler used for this study. Average flow rate is defined as the average inspiratory flow rate (Liters [L]/min) across the inhalation profile when inhaling across the resistance of the inhaler. PIFR is defined as the Peak Inspiratory Flow Rate (L/min) of the inhalation profile when inhaling across the resistance of the inhaler.The pressure drop during the inhalation was measured, and the inhalation profiles (pressure drop versus time profile) of the participants were obtained. The mean of the two inhalation profile measurements was used for each day (Days 1 and 14 of the respective treatment period), and the average flow rate and PIFR were determined.|Day 1 and Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Liters per minute (L/min)||Standard Deviation|Mean
2688665|NCT01332292|Secondary|Oropharyngeal Volume on Days 1 and 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Oropharyngeal volume is defined as the volume (cm^3) of the mouth and throat estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Days 1 and 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||cubic centimeters (cm^3)||Standard Deviation|Mean
2688666|NCT01332292|Secondary|Distance of Assessment on Days 1 and 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Distance of assessment is defined as the distance (length measured in centimeters [cm]) estimated to be from the lips to the larynx. Pharyngometry data were recorded for each day (Days 1 and 14 of each treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Days 1 and 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||centimeters (cm)||Standard Deviation|Mean
2688690|NCT01332253|Secondary|Time to Swallow Post Procedure.|Swallowing will be assessed every 15 minutes following arrival to the recovery room; the time to first swallow will be recorded.|every 15 minutes until able to swallow||||hours||Standard Error|Mean
2688691|NCT01332253|Secondary|Time to Discharge Post Procedure.|To evaluate the secondary objective of pain, the time to participant discharge will be measured.|Discharge||||hours||Standard Error|Mean
2712969|NCT01152385|Secondary|Number of Responders in Terms of HbA1C ≤ 6.5%||at 4th month|The analysis population was prior to rescue treatment (FAS)|||Participants|||Number
2688667|NCT01332292|Secondary|Average Oropharyngeal Cross-sectional Area on Days 1 and 14 of the Respective Treatment Period|During the pharyngometry assessment, participants inhaled through a wavetube, which had a mouthpiece with the same dimensions as the mouthpiece on the dry powder inhaler used for this study. This technique was used to measure the size of the throat and mouth (oropharynx) in the form of pharyngograms. Pharyngometry data were recorded for each day (Days 1 and 14 of the respective treatment period) using the mean of four measurements (pharyngograms), and the average oropharyngeal cross-sectional area was calculated.|Days 1 and 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||centimeters squared (cm^2)||Standard Deviation|Mean
2688668|NCT01332292|Secondary|Serum Cortisol Weighted Mean (0-12 Hours) on Day 14 of the Respective Treatment Period|Serum cortisol weighted mean was determined for each participant over the time period 0-12 hours on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period.|Day 14 of the respective treatment period|All Subjects Population. Only those participants available at the specified time point were analyzed.|||nanomoles per Liter||95% Confidence Interval|Geometric Mean
2688669|NCT01332292|Secondary|Tmax and t at Day 14 of the Respective Treatment Period|tmax is defined as the time to reach the observed maximum concentration, and t is defined as the time of the last observed quantifiable concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period.|Day 14 of the respective treatment period|PK Population. Only those participant who had quantifiable FF concentrations were analyzed.|||hours||Standard Deviation|Mean
2688670|NCT01332292|Secondary|Cmax on Day 14 of the Respective Treatment Period|Cmax is defined as the maximum observed concentration on Day 14 of the respective treatment period. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period.|Day 14 of the respective treatment period|PK Population|||picograms per milliliter (pg/mL)||95% Confidence Interval|Geometric Mean
2688671|NCT01332292|Secondary|AUC(0-t) on Day 14 of the Respective Treatment Period|Area under the concentration-time (AUC(0-t)) curve from time zero (pre-dose) to the last time of quantifiable concentration of FF on Day 14 of the respective treatment period was measured. Samples were collected at the following times: pre-dose; 30 minutes, 1, 2, 4, 7, and 12 hours post-dose on Day 14 of the respective treatment period. Due to non-quantifiable values, it was not possible to derive AUC(0-12).|Day 14 of the respective treatment period|Pharmacokinetic (PK) Population: all participants in the All Subjects Population for whom a PK sample was obtained and analyzed|||picograms*hour per milliliter (pg*hr/mL)||95% Confidence Interval|Geometric Mean
2688672|NCT01332292|Primary|Heart Rate at Baseline and Day 14 of the Respective Treatment Period|Heart rate (HR) was measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period.|Baseline and Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Beats per minute||Standard Deviation|Mean
2688673|NCT01332292|Primary|Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Baseline and Day 14 of the Respective Treatment Period|SBP and DBP were measured at Baseline and Day 14 of the respective treatment period. Baseline is defined as the pre-dose measurement at Day 1 for each period.|Baseline and Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimeters of mercury (mmHg)||Standard Deviation|Mean
2688674|NCT01332292|Primary|Peak Expiratory Flow on Day 1 and Day 14 of the Respective Treatment Period|Peak Expiratory Flow (PEF) is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. PEF is calculated as the maximum of three readings taken at each timepoint for each participant. Baseline is defined as the maximum pre-dose measurement at Day 1 for each period.|Day 1 and Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population, Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||liters/minute||Standard Deviation|Mean
2688675|NCT01332292|Primary|Total Bilirubin, Creatinine, and Uric Acid Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of total bilirubin, creatinine, and uric acid at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2688676|NCT01332292|Primary|Calcium, Chloride, Carbon Dioxide (CO2) Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of calcium, chloride, carbon dioxide content/bicarbonate (CO2/BI), glucose, potassium, sodium, and urea/BUN at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2688818|NCT01331837|Secondary|Time to First Occurrence of Individual Component of Primary Endpoint: Cardiovascular Death|Prospective comparison of time to first occurrence of Individual component of primary endpoint: cardiovascular death|From baseline up to 4.9 years|Analysis was conducted on the ITT population|||Months||95% Confidence Interval|Median
2688678|NCT01332292|Primary|Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), and Gamma Glutamyl Transferase (GGT) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of ALT, ALP, AST, and GGT at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||International units per liter (IU/L)||Standard Deviation|Mean
2688679|NCT01332292|Primary|Mean Corpuscle Hemoglobin (MCH) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCH at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||10^12 picograms (pg) per cell||Standard Deviation|Mean
2688680|NCT01332292|Primary|Mean Corpuscle Volume (MCV) Value at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of MCV at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed .|||10^15 femtoliters (fL) per cell||Standard Deviation|Mean
2688681|NCT01332292|Primary|Hematocrit Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hematocrit at Day 14 of the respective treatment period. Hematocrit is a measure of the percentage of the volume of the whole blood that is composed of red blood cells, as determined by separation of red blood cells from the plasma (usually by centrifugation).|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed.|||percentage of red blood cells in blood||Standard Deviation|Mean
2688682|NCT01332292|Primary|Reticulocyte and Red Blood Cell (RBC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of reticulocyte and RBCs at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^12 cells per liter (TI/L)||Standard Deviation|Mean
2688683|NCT01332292|Primary|Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of hemoglobin and MCHC at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||Grams per liter (g/L)||Standard Deviation|Mean
2688684|NCT01332292|Primary|Basophil, Eosinophil, Lymphocyte, Monocyte, Total Neutrophil, Platelet, and White Blood Cell Count Values at Day 14 of the Respective Treatment Period|Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelets, and white blood cell (WBC) count at Day 14 of the respective treatment period.|Day 14 of the respective treatment period (up to Study Day 44)|All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the All Subjects Population.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
2688685|NCT01332292|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.|From the start of study medication until Week 11 (Visit 6)/Early Withdrawal|All Subjects Population: all participants who received at least one dose of study medication|||participants|||Number
2688686|NCT01332253|Secondary|Blood Loss During Surgery|Amount of Blood Lost During Surgery in milliliters|End of Surgery|Blood loss during surgery in milliliters|||milliliters||Standard Deviation|Mean
2688687|NCT01332253|Secondary|Parental Satisfaction With Vomiting Control in the Post-Operative Period.|"To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to vomiting control. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 3 asked How satisfied were you with your child's vomiting management during the study?"|Discharge|Summary of Satisfaction Post-Procedure with Vomiting Control.|||participants|||Number
2688688|NCT01332253|Secondary|Parent Satisfaction With Regards to Nausea Management Post Procedure.|"To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to nausea management. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 2 asked How satisfied were you with your child's nausea management during the study?"|Discharge|Summary of Satisfaction Post-Procedure with nausea management during the study|||participants|||Number
2688689|NCT01332253|Secondary|Parent Satisfaction With Regards to Pain Management Post Procedure.|"To evaluate the secondary objective of pain, parental satisfaction during the post-operative period will be measured with regards to pain management. The Parental Satisfaction Survey asked the parent to base their response on their child's management from the time they arrive in the recovery room until they were discharged. Question 1 asked How satisfied were you with your child's pain management at the time of discharge?"|Discharge|Summary of Parent Satisfaction Post-Procedure with Pain Management at the time of discharge?|||participants|||Number
2688692|NCT01332253|Secondary|Postoperative Pain as Measured by the Visual Analog Scale (VAS) 120 Minutes Post-procedure.|"To evaluate the secondary objective of pain, the patient's self-reported pain at 120 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain."|120 minutes post-procedure|Patient reported pain was evaluated utilizing a visual analog scale (VAS) 120 minutes post-procedure.|||millimeters||Standard Deviation|Mean
2688693|NCT01332253|Secondary|Postoperative Pain as Measured by the Visual Analog Scale (VAS) 90 Minutes Post-procedure.|"o evaluate the secondary objective of pain, the patient's self-reported pain at 90 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain."|90 minutes post-procedure|Patient reported pain was evaluated utilizing a visual analog scale (VAS) 90 minutes post-procedure.|||millimeters||Standard Deviation|Mean
2688694|NCT01332253|Secondary|Postoperative Pain as Measured by the Visual Analog Scale (VAS) 60 Minutes Post-procedure.|"To evaluate the secondary objective of pain, the patient's self-reported pain at 60 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain."|60 minutes post-procedure|Patient reported pain was evaluated utilizing a visual analog scale (VAS) 60 minutes post-procedure.|||millimeters||Standard Deviation|Mean
2688695|NCT01332253|Secondary|Postoperative Pain as Measured by the Visual Analog Scale (VAS) 30 Minutes Post-procedure.|"The patient's self-reported pain at 30 minutes post-procedure will be measured using a VAS scale. The VAS is a continuous scale made up of a horizontal line, 100 mm in length, anchored by 2 verbal descriptors (No Pain, Worst Possible Pain). The VAS is self-completed by the respondent. The subject is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance, in mm, on the 100 mm line between the No Pain anchor and the subject's mark. The score would be between 0 and 100. A lower score represents less pain while a higher score represents more pain."|30 minutes post-procedure|Patient reported pain was evaluated utilizing a visual analog scale (VAS) 30 minutes post-procedure.|||millimeters||Standard Deviation|Mean
2688696|NCT01332253|Primary|Number of Doses of Fentanyl Administered in the Postoperative Period Prior to Discharge.|To evaluate the primary objective of reduced fentanyl use in the post-operative period, the number of fentanyl doses (0.5 mcg/kg IV) administered in the post-operative period prior to discharge will be measured.|4 hours||||fentanyl doses||Standard Deviation|Mean
2688697|NCT01332227|Secondary|Mean Changes in Fasting Lipid Levels From Baseline to Week 48|LD=low-density lipoprotein; HDL=high-density lipoprotein.|From Baseline to Week 48|All participants who received study drug|||mg/dL||Standard Error|Mean
2688698|NCT01332227|Secondary|Number of Patients With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Treatment-emergent Adverse Events (AEs) Leading to Discontinuation, and Treatment-emergent AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=having certain, probable, possible, or unknown relationship to study drug.|Day 1 to Week 48|All participants who received study drug|||Particpants|||Number
2688699|NCT01332227|Secondary|Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 48|Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients|Day 1 to Week 48|Participants with virologic rebound|||Participants|||Number
2688712|NCT01332188|Secondary|Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688713|NCT01332188|Secondary|Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2690357|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 48).|The change between the value of fasting blood glucose collected at week 48 and baseline.|Baseline and Week 48.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2688700|NCT01332227|Secondary|Number of Participants With Genotypable/Phenotypable Isolates, Emergent Genotypic Substitutions in Patients With Genotypable Isolates, and Phenotypic Resistance in Patients With Phenotypable Isolates at Week 24|Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates. pts=patients|Day 1 to Week 24|Patients who received study drug, who had an HIV-1 RNA measurement at the analysis week and who experienced virologic rebound.|||Participants|||Number
2688701|NCT01332227|Secondary|Number of Participants With Virologic Rebound at Weeks 24 and 48|Viral genotypic and phenotypic resistance profiles were assessed for virologic rebound (HIV-1 RNA level ≥40 c/mL). Only patients with HIV-1 RNA levels ≥500 c/mL met the criteria for resistance testing. Genotypic substitutions at baseline were summarized for virologic rebound. The genotypic resistance profile presented patients with genotypable isolates, those with protease inhibitor substitutions from genotypable isolates, those with integrase substitutions from genotypable isolates, and those with selected reverse transcriptase substitutions from genotypable isolates using the most current version of the International AIDS Society-USA list and Stanford HIV Drug Resistance Database. Newly emergent genotypic substitutions were summarized analogously for virologic rebound without baseline phenotypic resistance to atazanavir, ritonavir, or raltegravir, using all on-treatment isolates.|Day 1 to Weeks 28 and 48|All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week.|||Participants|||Number
2688702|NCT01332227|Secondary|Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 48|Percentages of patients with HIV-1 RNA levels <40 c/mL were summarized at each scheduled visit. Longitudinal plots were created to display proportion versus visit week through Weeks 24 and 48 with error bars representing 95% confidence intervals.|From Day 1 to Week 48|All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week.|||Percentage of participants||95% Confidence Interval|Number
2688703|NCT01332227|Primary|Percentage of Participants With HIV-1 RNA Level <40 c/mL at Week 24|HIV-1 RNA level was measured with the Abbott m2000rt® polymerase chain reaction assay. Response rates were assessed using an intent-to-treat algorithm, with numerator representing patients meeting the response criteria, and denominator representing all randomized patients. Randomized patients not meeting the criteria for treatment failure (eg, discontinuation of study therapy or virologic rebound at or before Week 24) were considered responders. Virologic rebound was defined as 2 consecutive on-treatment HIV-1 RNA levels ≥40 c/mL or the last on-treatment HIV-1 RNA level ≥40 c/mL followed by discontinuation. Patients who experienced treatment failure or had missing Week 24 HIV-1 RNA levels were considered failures. RNA=ribonucleic acid; HIV=human immunodeficiency virus.|From Day 1 to Week 24|All patients who received study drug and who had an HIV-1 RNA measurement at the analysis week.|||Percentage of participants||95% Confidence Interval|Number
2688704|NCT01332188|Secondary|Tolerability of Study Medication at Visit 3A|Subjects were asked to rate the comfort of the drop in each eye upon instillation, at 1 minute, and at 2 minutes after instillation of study medication. The assessment used a 10-point scale with 0 as very comfortable and 10 as very uncomfortable. Higher scores represent a worse outcome..|upon instillation, 1 minute and 2 minutes post instillation|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688705|NCT01332188|Secondary|Nasal Composite Score at Onset of Action (15 Minutes Post-dose)|A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||percentage of subjects|||Number
2688706|NCT01332188|Secondary|Nasal Composite Score at Duration of Action (24 Hours Post-dose)|A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||percentage of subjects|||Number
2688707|NCT01332188|Secondary|Nasal Composite Score at Duration of Action (16 Hours Post-dose)|A nasal composite score was summed for each patient based on the presence of at least one of the following four nasal symptoms on a 0-4 scale (0=none to 4=severe): rhinorrhea; nasal pruritus; ear or palate pruritus; and nasal congestion. The percentage of subjects with at least one nasal symptom present was calculated for each time point.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||percentage of subjects|||Number
2688708|NCT01332188|Secondary|Nasal Congestion at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688709|NCT01332188|Secondary|Nasal Congestion at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC||||units on a scale||Standard Deviation|Mean
2688710|NCT01332188|Secondary|Nasal Congestion at Onset of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688711|NCT01332188|Secondary|Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688719|NCT01332188|Secondary|Rhinorrhea at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688720|NCT01332188|Secondary|Tearing at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688721|NCT01332188|Secondary|Tearing at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688722|NCT01332188|Secondary|Tearing at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688723|NCT01332188|Secondary|Eyelid Swelling at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688724|NCT01332188|Secondary|Eyelid Swelling at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688725|NCT01332188|Secondary|Eyelid Swelling at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688726|NCT01332188|Secondary|Chemosis at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688727|NCT01332188|Secondary|Chemosis at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688728|NCT01332188|Secondary|Chemosis at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688729|NCT01332188|Secondary|Episcleral Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688730|NCT01332188|Secondary|Episcleral Redness at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688731|NCT01332188|Secondary|Episcleral Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688732|NCT01332188|Secondary|Ciliary Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.|||units on a scale||Standard Deviation|Mean
2688733|NCT01332188|Secondary|Ciliary Redness at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688734|NCT01332188|Secondary|Ciliary Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688735|NCT01332188|Primary|Conjunctival Redness at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688736|NCT01332188|Primary|Conjunctival Redness at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2694331|NCT01287416|Secondary|Suicidal Ideation in Past 2 Days at Baseline|Number of people who endorsed having thought about suicide in the past 2 days as measured at baseline (not at all vs a little to a lot)|July 19-20, 2010||||participants|||Number
2688737|NCT01332188|Primary|Conjunctival Redness at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.|7, 15, 20 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688738|NCT01332188|Primary|Ocular Itching at Onset of Action (15 Minutes Post-dose)|A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688739|NCT01332188|Primary|Ocular Itching at Duration of Action (24 Hours Post-dose)|A treatment efficacy CAC was performed 24 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688740|NCT01332188|Primary|Ocular Itching at Duration of Action (16 Hours Post-dose)|A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.|3, 5, 7 minutes post-CAC|Intent to Treat (ITT)|||units on a scale||Standard Deviation|Mean
2688741|NCT01332149|Secondary|Change From Baseline in HADS Depression Total Score at Endpoint|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2688742|NCT01332149|Secondary|Change From Baseline in HADS Anxiety Total Score at Endpoint|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2688743|NCT01332149|Secondary|Baseline Hospital Anxiety and Depression Scale (HADS) Scores|The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe.|Baseline|All participants in the FAS population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.|||units on a scale||Standard Deviation|Mean
2688744|NCT01332149|Secondary|Patient Global Impression of Change (PGIC) Score at Endpoint|The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant's perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).|Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2688745|NCT01332149|Secondary|Clinical Global Impression of Change (CGIC) at Endpoint|The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician's perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse).|Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2688746|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2688755|NCT01332149|Secondary|Change From Baseline in PPI Scale From the SF-MPQ at Endpoint|The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2712970|NCT01152385|Secondary|Number of Responders in Terms of HbA1C ≤ 7%||at 4th month|The analysis population was prior to rescue treatment (FAS)|||Participants|||Number
2688747|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2688748|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2688749|NCT01332149|Secondary|Percentage of Participants Who Had Optimal Sleep at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night.|Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||percentage of participants|||Number
2688750|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept).|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2688751|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2688752|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2688753|NCT01332149|Secondary|Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint|The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance.|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2688754|NCT01332149|Secondary|Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores|The MOS-Sleep Scale was a participant-rated instrument which assesses sleep quantity and quality with 12 items (7 subscale scores: sleep disturbance, snoring, awakening short of breath/with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep; and a 9-item overall sleep problems index). Subscale scores total range: 0-100 (except sleep quantity [range 0-24 hours], optimal sleep [yes:1, no:0]). Higher scores=poorer sleep outcomes (except sleep quantity, adequacy, and optimal sleep).|Baseline|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. N=number of evaluable participants for each category|||units on a scale||Standard Deviation|Mean
2688819|NCT01331837|Secondary|Percentage of Patients With Individual Component of Primary Endpoint: Non-fatal Myocardial Infarction|Percentage of patients reporting Individual component of primary endpoint: non-fatal Myocardial Infarction|From baseline up to 4.9 years|Anlysis was conducted on the ITT population|||Percentage of patients|||Number
2688756|NCT01332149|Secondary|Change From Baseline in Pain VAS From the SF-MPQ at Endpoint|The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain).|Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2688757|NCT01332149|Secondary|Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale|The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating).|Baseline|All participants in the FAS population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.|||units on a scale||Standard Deviation|Mean
2688758|NCT01332149|Secondary|Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9|SF-MPQ was assessed according to the participant's answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain.|Baseline; Weeks 1, 5, and 9|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=number of evaluable participants at the specified time point. No inferential analyses were performed.|||units on a scale||Standard Deviation|Mean
2688759|NCT01332149|Secondary|Percentage of 30 Percent (%) Responders at Endpoint|The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 63/Week 9) (Study Endpoint) compared to baseline.|End of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||percentage of participants|||Number
2688760|NCT01332149|Secondary|Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week. The overall change is the average change from Weeks 1 to 9.|Baseline and weekly from Weeks 1 to 9|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=number of evaluable participants at the specified time point.|||units on a scale||Standard Error|Least Squares Mean
2688761|NCT01332149|Secondary|Change From Baseline in Mean Sleep Interference Score at Endpoint|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 9 (Day 63) dose.|Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)|All participants in the FAS population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The LOCF method was used.|||units on a scale||Standard Error|Least Squares Mean
2688762|NCT01332149|Secondary|Baseline Mean Sleep Interference Score|Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10.|Baseline|All participants in the Full Analysis Set (FAS) population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.|||units on a scale||Standard Deviation|Mean
2688763|NCT01332149|Secondary|Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9|The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week. The overall change is the average change from Weeks 1 to 9.|Baseline and weekly from Weeks 1 to 9|The FAS population consisted of all participants randomized to treatment that received at least 1 dose of study medication. N=number of evaluable participants at the specified time point.|||units on a scale||Standard Error|Least Squares Mean
2688764|NCT01332149|Primary|Change From Baseline in Mean Pain Score at Endpoint|The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.|Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)|All participants in the Full Analysis Set (FAS) population (all participants randomized to treatment that received at least 1 dose of study medication) who had available data for this outcome measure. The Last Observation Carried Forward (LOCF) method was used.|||units on a scale||Standard Error|Least Squares Mean
2688765|NCT01332149|Primary|Baseline Mean Pain Score|The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.|Baseline|All participants in the Full Analysis Set (FAS) population, consisting of all participants randomized to treatment that received at least 1 dose of study medication.|||units on a scale||Standard Deviation|Mean
2688766|NCT01332123|Secondary|Heart Rate Change|Subjects were wearing a wireless heart rate monitor. The respective readings were noted and assessed during and immediately following the trials to estimate individual exertion rates. Changes in heart rate between resting and exertion across the sample were investigated to be able to interpret the primary outcome measures and to discuss limitations of the protocol. Unequal exertion rates within the sample would cause uneven trends biomechanical changes that are related to exertion.|1 hour||||beats/minute||Full Range|Mean
2688767|NCT01332123|Primary|Overall Asymmetry Index|"Gait data was continuously recorded and was post processed to determine symmetry between left and right legs. Symmetry was computed by dividing the difference between legs by the average of both legs. 0 marks perfect symmetry and greater values higher asymmetry. There is no maximum limit.~The overall asymmetry index was calculated as the mean of the following: max knee flex, dorsi flexion, plantar flexion (1st and 2nd peak), knee moment, dorsi-flexion moment, plantar-flexion moment, times of max in % of the gait cycle, Stance phase % of gait cycle and step length.~The kinematics asymmetry index was calculated as the mean of the following: maximal knee flex, dorsi flexion, plantar flexion (1st and 2nd peak), the times of max in % of the gait cycle, Stance phase % of gait cycle and step length.~The kinetics asymmetry index was calculated as the mean of the following variables: knee moment, dorsi-flexion moment, plantar-flexion moment, the times of max in % of the gait cycle."|1 hour|Two of the recruited participants were not included in the analysis, as they had bilateral amputations. Bilateral amputation was not posted as an exclusion criteria initially, but posted unanticipated limitations during data collection and analysis.|||unit-less index (0 = perfect symmetry)||Standard Deviation|Mean
2688768|NCT01332071|Primary|Cmax of Metformin Hydrochloride|"Cmax is defined as the maximum or peak concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed."|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study|||ng/ml||Standard Deviation|Mean
2688769|NCT01332071|Primary|AUC0-infinity of Metformin Hydrochloride|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study|||ng.h/ml||Standard Deviation|Mean
2688770|NCT01332071|Primary|AUC0-t of Metformin Hydrochloride|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study|||ng.h/ml||Standard Deviation|Mean
2688771|NCT01332071|Primary|AUC0-infinity of Rosiglitazone Maleate|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC0-infinity is calculated from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study|||ng.h/ml||Standard Deviation|Mean
2688772|NCT01332071|Primary|Cmax of Rosiglitazone Maleate|"Cmax is defined as the maximum or peak concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed."|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study|||ng/ml||Standard Deviation|Mean
2688773|NCT01332071|Primary|AUC0-t of Rosiglitazone Maleate|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC 0-t is calculated from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration). The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.|Day 1 (day that blood collection started) and Day 2 (Period 1) and Days 8 and 9 (Period 2)|Participants who completed the study|||ng per hour per ml (ng.h/ml)||Standard Deviation|Mean
2688774|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question Main reason for missed injections? answer choices were given as medication side effects, injection pain, forget to take medication, tired of taking injections, don't think medication is working, or other. Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment who missed at least 1 injection at given timepoint.|||participants|||Number
2688775|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question Over the past 4 weeks, did you miss any of your injections? answer choices were given as none missed, miss 1 injection, or miss 2 injections. Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||participants|||Number
2688776|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: I Am Satisfied With the Dosing Frequency of This Medication.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the statement I am satisfied with the dosing frequency (2 times per month) of this medication answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2688777|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: This Medication Improves My Self-Confidence and Self-Reliance.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the statement This medication improves my self-confidence and self-reliance, answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2688778|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Enables Me to Be More Spontaneous and Flexible.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the statement The twice a month dosing enables me to be more spontaneous and flexible, answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2688779|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Makes It More Convenient for Me to Travel/Vacation.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the statement The twice a month dosing makes it more convenient for me to travel/vacation, answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2688780|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: This Medication Makes It Easy For Me to Carry Out My Daily Responsibilities.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the statement This medication makes it easy for me to carry out my daily responsibilities (ie, going to work, doing household chores or caring for my family), answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2688781|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS.|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the statement This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS, answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2688782|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Likely Would You Be to Continue to Use This Medication?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question How likely would you be to continue to use this medication? answers were numerically rated from 1 (extremely unlikely) to 10 (extremely likely). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2688783|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Satisfied or Dissatisfied Are You With the Injection Frequency (Every 2 Weeks)?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question How satisfied or dissatisfied are you with the injection frequency (every 2 weeks)? answers were numerically rated from 1 (extremely dissatisfied) to 10 (extremely satisfied). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2688784|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: Overall, How Satisfied or Dissatisfied Are You With This Medication?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question Overall, how satisfied or dissatisfied are you with this medication? answers were numerically rated from 1 (extremely dissatisfied) to 10 (extremely satisfied). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2690358|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 44).|The change between the value of fasting blood glucose collected at week 44 and baseline.|Baseline and Week 44.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2688785|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication Every 2 Weeks?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question How convenient or inconvenient is it to take your medication every 2 weeks? answers were numerically rated from 1 (extremely inconvenient) to 10 (extremely convenient). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2688786|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication as Instructed?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question How convenient or inconvenient is it to take your medication as instructed? answers were numerically rated from 1 (extremely inconvenient) to 10 (extremely convenient). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2688787|NCT01332019|Secondary|Summary of Participant-Reported Treatment Satisfaction: How Tolerable or Intolerable Do You Find the Medication?|"Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question How tolerable or intolerable do you find the medication? answers were numerically rated from 1 (extremely intolerable) to 10 (extremely tolerable). Data after Amendment 3 took effect are excluded."|Year 1, Year 2, Year 3|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2688788|NCT01332019|Secondary|Number of MS-Related Hospitalizations|Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|up to 4 years|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment|||hospitalizations|||Number
2688789|NCT01332019|Secondary|Number of Relapses Requiring IV Steroid Use|Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|up to 4 years|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment|||relapses|||Number
2688790|NCT01332019|Secondary|Change From Baseline in EQ-5D Visual Analogue Scale (VAS)|The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.' The scale was normalized to a scale of 0 to 1, with higher values indicating a better health state. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2688791|NCT01332019|Secondary|Change From Baseline in Euro Quality of Life (EQ-5D) Index Score|The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Scores of 1, 2, or 3 are possible responses for each of 5 questions (1=no problems, 2=some problems, 3=severe problems). A scoring formula developed by the EuroQol Group is then used to assign utility values for each participant's Health State Profile. A summary index score (EQ-5D index score) is derived from the 5 questions by conversion with this scoring formula and a table of scores. EQ-5D Summary Index values ranged from -0.6 (worst health state) to 1.00 (perfect health state). Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2688792|NCT01332019|Secondary|Change From Baseline in SF-12 Physical Component Score (PCS)|The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. PCS was computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health and 100 indicates the highest level of health. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2688793|NCT01332019|Secondary|Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS)|The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. MCS computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health and 100 indicates the highest level of health. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2688805|NCT01332019|Secondary|Number of New or Newly Enlarging T2 Hyperintense Lesions|The total number of new or newly enlarging T2 hyperintense lesions (from Study 105MS302 Baseline) as assessed by magnetic resonance imaging (MRI). Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.|||lesions||Standard Deviation|Mean
2712971|NCT01152385|Secondary|Change in Fasting Plasma Glucose (FPG)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)|||mg/dL||Standard Deviation|Mean
2688794|NCT01332019|Secondary|Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score|The 29-item MSIS-29 is a disease-specific participant-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Responses use a 5-point Likert scale ranging from 1 to 5. All questions are to be answered. The physical well being assessment portion of the MSIS-29 consists of 20 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 20-100. A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a participant's functioning. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2688795|NCT01332019|Secondary|Change From Baseline in Symbol Digit Modalities Test (SDMT)|SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 (worst) to 110 (best).|Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2688796|NCT01332019|Secondary|Time to Sustained Disability Progression|Estimated proportion of participants with progression and time to progression based on the Kaplan-Meier product limit method. Sustained disability progression is defined as: at least a 1.0 point increase on the EDSS from 105MS302 baseline EDSS ≥ 1.0 that is sustained for 24 weeks, or at least a 1.5 point increase on the EDSS from 105MS302 baseline EDSS = 0 that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Participants were censored at the time of withdrawal/switch/A3 effective date if they withdrew from study, switched to alternative MS medication, or Amendment 3 took effect without a progression.|Weeks 12, 24, 28, 72, 96, 120, 144, 168|Participants in the ITT population (all participants who were assigned a treatment and received at least 1 dose of study treatment) with disability progression.|||proportion of participants|||Number
2688797|NCT01332019|Secondary|Change From Baseline in Expanded Disability Status Scale (EDSS)|Change from Baseline in disability as measured by the Expanded Disability Status Scale (EDSS). The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Weeks 12, 24, 48, 72, 96, 120, 144, 168|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.|||units on a scale||Standard Deviation|Mean
2688798|NCT01332019|Secondary|Percentage Change of Whole Brain Volume|Percentage change of whole brain volume as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.|||percentage change||Standard Deviation|Mean
2688799|NCT01332019|Secondary|Volume of Gd-Enhancing Lesions|The volume of Gd-enhancing lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.|||cm^3||Standard Deviation|Mean
2688800|NCT01332019|Secondary|Volume of T1 Hypointense Lesions|The volume of T1 hypointense lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.|||cm^3||Standard Deviation|Mean
2688801|NCT01332019|Secondary|Volume of T2 Hyperintense Lesions|The volume of T2 hyperintense lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.|||cm^3||Standard Deviation|Mean
2688802|NCT01332019|Secondary|Number of Gd-Enhancing Lesions|The number of Gd-enhancing lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Baseline (start of 105MS302), Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.|||lesions||Standard Deviation|Mean
2688803|NCT01332019|Secondary|Number of New T1 Hypointense Lesions|The total number of new T1 hypointense lesions as assessed by MRI.|Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.|||lesions||Standard Deviation|Mean
2688804|NCT01332019|Secondary|Number of New Active Lesions|The number of new active lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.|Week 48, Week 96|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.|||lesions||Standard Deviation|Mean
2688817|NCT01331837|Secondary|Percentage of Patients With Individual Component of Primary Endpoint: Cardiovascular Death|Percentage of patients reporting Individual component of primary endpoint: cardiovascular death|From baseline up to 4.9 years|Analysis was conducted on the ITT population|||Percentage of patients|||Number
2688806|NCT01332019|Secondary|Percentage of Participants Who Relapsed|Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. New or recurrent neurologic symptoms that occur less than 30 days following the onset of a relapse were considered part of the same relapse. Participants who did not experience a relapse prior to switching to alternative MS medications, withdrew from study, or Amendment 3 (A3) took effect were censored at the time of switch/withdrawal/A3 effective date.|Up to 4 years|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment.|||percentage of participants|||Number
2688807|NCT01332019|Secondary|Annualized Relapse Rate (ARR)|Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. The annualized relapse rate is calculated as the total number of relapses occurred during the period for all participants, divided by the total number of person-years followed in the period.|up to 4 years|ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment.|||relapses per person-years|Relapses|95% Confidence Interval|Number
2688808|NCT01332019|Primary|Number of Participants With Shifts From Baseline: Urinalysis|Shift to low includes normal to low, high to low, and unknown to low. Shift to high/positive includes normal to high/positive, low to high/positive, negative to high/positive, and unknown to high/positive. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. Pos=positive; RBC=red blood cells; WBC=white blood cells.|Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years|Safety population: all participants who received at least 1 dose of study drug; n=number of participants whose baseline value was not low or high/positive and who had at least 1 post-baseline value.|||participants|||Number
2688809|NCT01332019|Primary|Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry|Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. TSH=thyroid stimulating hormone.|Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years|Safety population: all participants who received at least 1 dose of study drug; n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.|||participants|||Number
2688810|NCT01332019|Primary|Number of Participants With Shifts From Baseline: Liver Function Laboratory Values|Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. ALT=alanine aminotransferase; AST=aspartate aminotransferase; GGT=gamma-glutamyl transferase.|Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years|Safety population: all participants who received at least 1 dose of study drug; n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.|||participants|||Number
2688811|NCT01332019|Primary|Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities|Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing.|up to 4 years|Safety population: all participants who received at least 1 dose of study drug and at least 1 post-baseline value for given parameter.|||participants|||Number
2688812|NCT01332019|Primary|Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs|AE: any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. SAE: any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing.|up to 4 years|Safety population: all participants who received at least 1 dose of study drug. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded.|||participants|||Number
2688813|NCT01331837|Secondary|Percentage of Patients With Individual Component of Primary Endpoint: All-cause Mortality|Percentage of patients reporting Individual component of primary endpoint: All-cause mortality|From baseline up to 4.9 years|Analysis was conducted on the ITT population.|||Percentage of patients|||Number
2688814|NCT01331837|Secondary|Time to First Occurrence of Individual Component of Primary Endpoint: All-cause Mortality|Prospective comparison of time to first occurrence of Individual component of primary endpoint: All-cause mortality|From baseline up to 4.9 years|Analysis was conducted on the ITT population.|||Months||95% Confidence Interval|Median
2688815|NCT01331837|Secondary|Percentage of Patients With Individual Component of Primary Endpoint: Non-fatal Stroke||From baseline up to 4.9 years|Analysis was conducted on the ITT population|||Percentage of patients|||Number
2688816|NCT01331837|Secondary|Time to First Occurrence of Individual Component of Primary Endpoint: Non-fatal Stroke|Prospective comparison of time to first occurrence of Individual component of primary endpoint: non-fatal stroke|From baseline up to 4.9 years|Analysis was conducted on the ITT population|||Months||95% Confidence Interval|Median
2690359|NCT01318122|Secondary|Change From Baseline in Fasting Blood Glucose (Week 40).|The change between the value of fasting blood glucose collected at week 40 and baseline.|Baseline and Week 40.|Values are from the Full Analysis Set.|||mg/dL||Standard Deviation|Mean
2688820|NCT01331837|Secondary|Time to First Occurrence of Individual Component of Primary Endpoint: Non-fatal Myocardial Infarction|Prospective comparison of time to first occurrence of Individual component of primary endpoint: non-fatal Myocardial Infarction|From baseline up to 4.9 years|Anlysis was conducted on the ITT population.|||Months||95% Confidence Interval|Median
2688821|NCT01331837|Secondary|Percentages of Participants With an Expanded CV Composite Endpoint|Percentages of participants with the expanded CV composite endpoint. The expanded composite endpoint is defined as the CV composite of the primary endpoint with the addition of non-elective coronary revascularization procedures and hospitalization for unstable angina.|From baseline up to 4.9 years|Analysis was conducted on the ITT population.|||Percentages of participants|||Number
2688822|NCT01331837|Secondary|The Time to First Occurrence of an Expanded CV Composite Endpoint|Prospective comparison of the time to first ccurrence of the expanded composite endpoint. The expanded composite endpoint is defined as the CV composite of the primary endpoint with the addition of non-elective coronary revascularization procedures and hospitalization for unstable angina.|From baseline up to 4.9 years|Analysis was conducted on the ITT population.|||Months||95% Confidence Interval|Median
2688823|NCT01331837|Primary|Percentage of Participants With a CV-EAC Adjudicated Event Before Last Direct Contact Date|Percentage of participants with any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke before last direct contact date (i.e., latest date of visit, IVRS call, or site call).|From Baseline up to 4.9 years|Analysis was conducted on the ITT population|||Percentage of participants with event|||Number
2688824|NCT01331837|Primary|Time to First CV-EAC Adjudicated Event Before Last Direct Contact Date|Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke before last direct contact date (i.e., latest date of visit, IVRS call, or site call).|From Baseline up to 4.9 years|Analysis was conducted on the ITT population|||Months||95% Confidence Interval|Median
2688825|NCT01331837|Primary|Percentage of Patients With a CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis|Percentage of patients with any component of the composite of CV death (excluding events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analyses|From baseline up to 4.9 years|Analysis was conducted on the ITT population|||Percentage of patients with event|||Number
2688826|NCT01331837|Primary|Time to First CV-EAC Adjudicated Event Excluding Undetermined Cause of Death - Sensitivity Analysis|Prospective comparison of time to first occurrence of any component of the composite of CV death (excluding events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analyses|From baseline up to 4.9 years|Analysis was conducted on the ITT population|||Months||95% Confidence Interval|Median
2688827|NCT01331837|Primary|Percentage of Patients With a CV-EAC Adjudicated Event - Sensitivity Analysis|Percentage of patients with any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analysis|From Baseline up to 4.9 years|Analyses was conducted on the On-treatment (OT) population, i.e. patients who switched from randomized treatment were censored at the time of treatment switching.|||Percentage of patients with event|||Number
2688828|NCT01331837|Primary|Time to First CV-EAC Adjudicated Event - Sensitivity Analysis|Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke - Sensitivity Analysis|From Baseline up to 4.9 years|Analyses was conducted on the On-treatment (OT) population, i.e. patients who switched from randomized treatment were censored at the time of treatment switching.|||Months||95% Confidence Interval|Median
2688829|NCT01331837|Primary|Percentage of Patients Reporting a Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event|Percentage of patients reporting any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke|From baseline up to 4.9 years|Analysis was conducted on the Intention to treat (ITT) population, i.e. all patients randomized who have taken at least one dose of study medication|||Percentage of patients with event|||Number
2688830|NCT01331837|Primary|Time to First Cardiovascular (CV) Events Adjudication Committee (EAC) (CV-EAC) Adjudicated Event|Prospective comparison of time to first occurrence of any component of the composite of CV death (including events adjudicated as 'Undetermined Cause of Death'), non-fatal myocardial infarction, or non-fatal stroke.|From baseline up to 4.9 years|Analysis was conducted on the Intention to treat (ITT) population, i.e. all patients randomized who have taken at least one dose of study medication|||Months||95% Confidence Interval|Median
2688831|NCT01331824|Secondary|Safety as Measured by the Frequency and Type of Adverse Events as Per the Common Terminology for Adverse Events (CTCAE) Version 4.0.|Types of adverse events listed in Adverse Event Section|Day 1 of each treatment cycle; and 21 days after the last dose of amrubicin||||adverse events|||Number
2688832|NCT01331824|Secondary|Overall Survival|The median overall survival|1 year||||months||95% Confidence Interval|Median
2688833|NCT01331824|Secondary|Progression-free Survival|"The median progression-free survival~After the last dose of Amrubicin, patients will have follow-up every 3 months with a repeat CT scan of the chest, abdomen, and pelvis until the time of disease progression is documented."|Every 3 months post Amrubicin administration||||months||95% Confidence Interval|Median
2688834|NCT01331824|Primary|Objective Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)|"Response to treatment based on tumor measurements via CT chest, abdomen, and pelvis for restaging after every 2 cycles.~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.~Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."|6 weeks||||percentage of participants||95% Confidence Interval|Number
2689007|NCT01329978|Secondary|Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)|SVR12 was defined as HCV RNA < LOD 12 weeks after the last dose of study drug.|Post-treatment Week 12|Participants in the Safety Analysis Set with available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2688835|NCT01331694|Secondary|Average Annual Adjusted Post-Index COPD-Related Costs|Medical costs are associated with COPD-related medical care (claims submitted with a primary International Classification of Diseases, 9th Revision, Clinical Modification diagnosis of COPD) and pharmaceutical care (treatment arm medications, oral corticosteroids, oral antibiotics, short-acting beta-agonists, long-acting beta-agonists [LABA], inhaled corticosteroids [ICS], ICS/LABA combinations, etc.. Means are adjusted for age, sex, geographic region, pre-initial treatment comorbidities, and COPD-related utilization. Total costs are the sum of medical care and pharmacy costs.|Incurred over the 12 month period after initial treatment arm prescription|All participants from a large database comprised of information from enrollment files and facility, professional service, and outpatient pharmacy claims from a variety of private healthcare benefit plans covering over 40 million patients enrolled in over 70 health plans (providing data continuously) across the United States|||United States dollars||Standard Deviation|Mean
2688836|NCT01331694|Primary|Time to First Chronic Obstructive Pulmonary Disease (COPD) Event|The first COPD event occurring after 30 days from initial treatment arm prescription was measured. Four categories of COPD events were analyzed; either a hospitalization or emergency department visit; an emergency department visit; an outpatient visit followed by an oral corticosteroid prescription claim within 10 days; an outpatient visit followed by an oral antibiotic prescription claim within 10 days.|Anytime from 30 days to 12 months after initial treatment arm prescription|All participants from a large database comprised of information from enrollment files and facility, professional service, and outpatient pharmacy claims from a variety of private healthcare benefit plans covering over 40 million patients enrolled in over 70 health plans (providing data continuously) across the United States.|||days||Standard Error|Mean
2688837|NCT01331681|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Distance Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Distance activities are defined as reading street signs or names on stores, and going down stairs, steps, or curbs.|Baseline up to Week 52|Full-Analysis Set with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2688838|NCT01331681|Secondary|Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Near Activities Subscale at Week 52 - LOCF|The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales that are all scored from 0-100. Near activities are defined as reading ordinary print in newspapers, performing work or hobbies requiring near vision, or finding something on a crowded shelf.|Baseline up to Week 52|Full-Analysis Set with assessment for this outcome measure.|||Scores on a scale||Standard Deviation|Mean
2688839|NCT01331681|Secondary|Change From Baseline in Central Retinal Thickness (CRT) at Week 52 as Assessed on Optical Coherence Tomography (OCT) - LOCF||Baseline up to Week 52|Full-Analysis Set with assessment for this outcome measure.|||micrometer||Standard Deviation|Mean
2688840|NCT01331681|Secondary|Percentage of Participants With a ≥2-step Improvement From Baseline in the ETDRS DRSS (Diabetic Retinopathy Severity Score) as Assessed by FP (Fundus Photography) at Week 52 - LOCF|Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)|Baseline up to Week 52|Full-Analysis Set with assessment for this outcome measure.|||Percentage of participants|||Number
2688841|NCT01331681|Secondary|Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to Week 52|FAS.|||Percentage of participants|||Number
2688842|NCT01331681|Secondary|Percentage of Participants Who Gained at Least 10 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 52 - LOCF|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to Week 52|FAS.|||Percentage of participants|||Number
2688843|NCT01331681|Primary|Change From Baseline in BCVA (Best Corrected Visual Acuity) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF)|Visual function of the study eye was assessed using the ETDRS protocol. A higher score represents better functioning.|Baseline up to Week 52|Full analysis set (FAS) included all randomized participants who received any study treatment, had a baseline measurement of BCVA, and had at least 1 post-baseline assessment of BCVA.|||Letters correctly read||Standard Deviation|Mean
2688844|NCT01331408|Secondary|Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 12|"To Evaluate the Perceived Improvement at 12 Months Compared to Baseline as Judged by the Subject Using GEIS.~Percentage of subjects with Improved, Much Improved or Very Much Improved on GEIS, Subject's evaluation."|12 Months|Intention To Treat. Subjects with data available|||percentage of participants||95% Confidence Interval|Number
2688845|NCT01331408|Secondary|Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 1|"To evaluate the perceived improvement at 1 month compared to baseline as judged by the Subject using GEIS.~Percentage of subjects with improved, much improved or very much improved on GEIS, subject's evaluation."|1 Month|Intention to treat, subjects with available data|||percentage of participants||95% Confidence Interval|Number
2688846|NCT01331408|Primary|Percentage of Participants With Improvement on the Global Esthetic Improvement Scale (GEIS) at Month 6|"To evaluate the perceived improvement at 6 months compared to baseline as judged by the Subject using Global Esthetic Improvement Scale (GEIS).~Percentage of subjects with improved, much improved or very much improved on GEIS, subject's evaluation."|6 Months|Intention to treat, subjects with available data|||percentage of participants||95% Confidence Interval|Number
2688847|NCT01331304|Secondary|Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)|The LIFE-RIFT asses the extent to which psychopathology has impacted current functioning in work, household chores, interpersonal relationships with partner, family, and friends, recreational activities, and life, satisfaction, leisure activities and social relationships. Summary scores can range from 4 to 20, with higher scores indicating greater functional impairment.|Average baseline score minus Average 6-month score||||units on a scale||95% Confidence Interval|Mean
2688848|NCT01331304|Secondary|Risk of Cardiovascular Disease - Framingham Risk Score|The Framingham risk score captures the classic risk factors for cardiovascular disease, including age, sex, systolic blood pressure, total and high density lipoprotein cholesterol, diabetes mellitus, and smoking. The Framingham risk score is used as a simple predictive tool to determine 10-year (short term) risk for developing cardiovascular disease (CHD), with higher scores indicating higher risk. Established benchmarks exist for scores from 0 to 25--though it can exceed this value--that are meant to translate to the probability of developing heart disease.|Average baseline score minus Average 6 month score||||units on a scale||95% Confidence Interval|Mean
2688849|NCT01331304|Primary|Necessary Clinical Adjustments|Necessary Clinical Adjustment (NCA): The Medication Recommendation Tracking Form was developed and successfully implemented in a previous study to capture recommended medication changes at each study visit 17. Clinicians record dosage changes, missed doses, new medications added or discontinued, and specify the reason for each change. Any change in psychotropic medications, or medications used to treat side effects, is coded along with the reason for the change. NCAs include those changes made for lack of effectiveness or intolerance, but not changes for planned dose titrations.|6 Months||||Mean NCAs per month||Standard Deviation|Mean
2688850|NCT01331304|Primary|Clinical Global Impression-Efficacy Index (CGI-EI)|The CGI-EI integrates benefits and harms and yields a score that can be compared across interventions. It is made up of 2 subscales: therapeutic effects and side effects. Each rating is on a scale from 1 to 4. To combine these two subscales into the CGI-EI we report as our primary outcome, we subtracted the side effects subscale from the therapeutic effects subscale. Thus, the CGI-EI we report ranges the integers from -3 to +3 (i.e. possible scores are -3,-2,-1,0,1,2,3). A score of -3 is the most burdensome side effect score (4) and the least therapeutic effect score (1) and a score of +3 is the least burdensome side effect score (1) and the highest therapeutic effect score (4). Higher CGI-EI signifies better outcome (minimal side effects, maximal therapeutic effect). Lower CGI-EI signifies worse outcome (maximal side effects, minimal therapeutic effect).To compute CGI-EI score, we subtract the side effect score from the therapeutic effect score.|Average 6 month score minus Average baseline score||||Units on the scale||95% Confidence Interval|Mean
2688851|NCT01331291|Secondary|Anti-tumor Response|Assess anti-tumor response in patients in Arm B using MacDonald criteria. There are four possible responses: complete response, partial response, stable disease, or progressive disease. Criteria are based on measurements of tumor dimension as visualized with a contrast-enhanced MRI.|2 years|Only Arm B participants were evaluable for this outcome measure|||participants|||Number
2688852|NCT01331291|Secondary|Safety Profile|Overall safety profile will be characterized by type, frequency, severity (as graded by NCI CTCAE), timing and relationship of study therapy of adverse events and laboratory abnormalities. Safety and tolerability will be measured by the proportion of patients who experience Grade 3 or higher Adverse Events that are possibly, probably or definitely related to bosutinib and the number of same Adverse Events per patient. Adverse Events will be summarized by treatment for each arm by the frequency of patients experiencing treatment emergent adverse events.|2 years||||participants|||Number
2688853|NCT01331291|Secondary|Intratumoral Concentration|Assess the intratumoral concentration of bosutinib in recurrent glioblastoma patients who are candidates for surgical re-resection (ARM A).|2 years|Participants in Arm B were never eligible for this outcome measure. Because only two participants were enrolled to Arm A, this analysis was not done as there were not sufficient tumor samples to generate meaningful results.||||||
2688854|NCT01331291|Primary|Progression-Free Survival|Assess progression-free survival at six months in patients with recurrent glioblastoma at first or second recurrence who are treated with continuous daily dosing of bosutinib (Arm B). Progression-free survival is measured from initiation of study treatment to date of progression.|2 years|This outcome was only applicable to participants enrolled on Arm B.|||weeks||95% Confidence Interval|Median
2688855|NCT01331213|Secondary|Post-treatment Sensory Threshold for Gas|The sensory threshold for first perception of gas was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. The balloon was placed in the mid-descending or junction of the sigmoid and descending colon. During this assessment participants were asked to report when they had the first perception of gas. The investigator recorded the threshold pressure at which the participants reported this sensation.|Approximately 60 minutes after drug administration||||mm Hg||Standard Deviation|Mean
2688856|NCT01331213|Secondary|Colonic Motility Index|The postprandial motility index (MI)=log_e[number of contractions * sum of amplitudes) + 1] A normal fasting average motility index (MI) would be about 12. An increase in MI means an increase in the phasic contractions (in contrast to tone) which is measured as a change in volume of the barostatically-controlled balloon. (Therefore, an increase in MI means that the meal is moving more quickly through the colon.)|Approximately 1 hour after meal||||log mm Hg||Standard Deviation|Mean
2688857|NCT01331213|Secondary|Fasting Colonic Tone|Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon.)|Approximately 60 minutes after drug administration||||mL||Standard Deviation|Mean
2688858|NCT01331213|Primary|Overall Sensory Ratings in Response to 16, 24, 30 and 36 mm Hg Distensions.|The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Pain sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain.|Approximately 60 minutes after drug administration||||mm||Standard Deviation|Mean
2688859|NCT01331213|Primary|Sensory Threshold for Pain|The sensory threshold for first perception of pain was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. The balloon was placed in the mid-descending or junction of the sigmoid and descending colon. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation.|approximately 60 minutes after drug administration||||mm Hg||Standard Deviation|Mean
2689194|NCT01328405|Secondary|Airway Pathology|In the recovery area, once the patient is fully awake, as judged by the recovery staff, an observer will administer a standard oral questionnaire to the patient to determine if a sore throat is present.|Postoperative (day 1) in recovery room||||participants|||Number
2688860|NCT01331213|Primary|Postprandial Colonic Tone [Reported as the Symmetric Percent [Change} in Baseline Colonic Barostat Balloon Volume|The symmetric percent reduction in baseline colonic barostat balloon volume during the first 30 minutes postprandially (PP) corrected for the preprandial (30 min) tone, (symmetric percent change= 100*log_e[fasting/PP]). A positive symmetric percent change reflects a decrease in barostat balloon volume indicating a reduction in colonic tone. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.)|The first 30 minutes postprandially, and preprandial (30 minutes)||||Symmetric percentage change||Standard Deviation|Mean
2688861|NCT01331213|Primary|Colonic Compliance|"Colonic compliance is a measure of the stiffness of the colon, that is, what pressure was needed to reach half the maximum volume of the colon. After the barostat balloon catheter was inserted in the mid-descending or junction of the sigmoid and descending colon, the balloon was inflated. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance."|baseline (1 hour before drug administration), post-treatment (1 hour after drug administration)||||mm Hg||Standard Deviation|Mean
2688862|NCT01331161|Secondary|The Number of Participants With Innate Immune Signatures That Correlate With the B and T Cells Adaptive Immunity Responses After ZOSTAVAX|The number of participants with innate immune signatures in the young and old groups that correlate with the B and T cells adaptive immunity responses after ZOSTAVAX|2 years|Participants with both T and B cell responses to vaccine|||participants|||Number
2688863|NCT01331161|Primary|Number of Participants With Innate Immunity Signatures That Correlate With the T Cell Adaptive Immunity Responses After ZOSTAVAX|The primary outcomes will identify the number of participants with innate immunity signatures in the young and older groups that correlate with the T cell adaptive immunity responses after ZOSTAVAX|2 years|participants with immunoglobulin gene responses that correlated with adaptive immune responses|||participants|||Number
2688864|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Any Suicidal Behavior as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal behaviors as defined by the eC-SSRS are:~Preparatory acts or behavior~Aborted attempt~Interrupted attempt~Actual attempt~Completed suicide attempt"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.|||participants|||Number
2688865|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 1 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:~Level 1: Wish to be Dead~Level 2: Non-Specific Active Suicidal Thoughts~Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act~Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan~Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.|||participants|||Number
2688866|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 2 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:~Level 1: Wish to be Dead~Level 2: Non-Specific Active Suicidal Thoughts~Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act~Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan~Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.|||participants|||Number
2688867|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 3 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:~Level 1: Wish to be Dead~Level 2: Non-Specific Active Suicidal Thoughts~Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act~Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan~Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.|||participants|||Number
2688868|NCT01331109|Primary|Adverse Events|Number of Patients who experience one or more treatment emergent adverse event (TEAE)|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.|||participants|||Number
2688869|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 4 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:~Level 1: Wish to be Dead~Level 2: Non-Specific Active Suicidal Thoughts~Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act~Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan~Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.|||participants|||Number
2688884|NCT01330953|Secondary|Pharmacokinetics, Area Under the Curve (AUC)|Area under the LY2928057 plasma concentration-time curve extrapolated to infinite time (AUC0-∞).|Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85|The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic AUC analyses.|||nanogram*hour per milliliter (ng*h/mL)||Geometric Coefficient of Variation|Geometric Mean
2688870|NCT01331109|Other Pre-specified|Number of Patients Who Experienced Level 5 Suicidal Ideation, as Assessed by the Electronic Columbia-Suicide Severity Rating Scale (eC-SSRS).|"The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) is a validated, self-rated version of the C-SSRS designed to uniquely assess both suicidal behavior and ideation. Suicidal ideation is assessed at 5 distinct levels of increasing severity:~Level 1: Wish to be Dead~Level 2: Non-Specific Active Suicidal Thoughts~Level 3: Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act~Level 4: Active Suicidal Ideation with Some Intent to Act, without Specific Plan~Level 5: Active Suicidal Ideation with Specific Plan and Intent"|Baseline (Visit 1) to Week 53 (Visit 9)|57 patients who took at least 1 dose of open-label milnacipran were included in the safety population.|||participants|||Number
2688871|NCT01331005|Secondary|Change in OCT Central Subfield Thickness|95% CI will be obtained in each treatment group and compared between treatment groups at 1 year. For eyes that have received treatment for DME before 1 year, visual acuity and OCT measurements obtained at time of failure will be used instead of measurements at 1 year.|baseline to 12 months||||microns||Standard Deviation|Mean
2688872|NCT01331005|Secondary|Mean Change in Visual Acuity|The 95% CI will be obtained in each treatment group and compared between treatment groups at 1 year. For eyes that have received treatment for diabetic macular edema(DME) before 1 year, visual acuity and optical coherence tomography (OCT) measurements obtained at time of failure will be used instead of measurements at 1 year.|baseline to 12 months|Original 12-month values are not available in 4 eyes of each of nepafenac and placebo groups because 12-month visit was not completed and were imputed from the last available measurement; values at or before first diabetic macular edema treatment were carried forward in 5 and 3 eyes of nepafenac and placebo groups respectively.|||Letter Score||Standard Deviation|Mean
2688873|NCT01331005|Primary|Mean Change in Optical Coherence Tomography Measure Retinal Volume, mm3||From Baseline to 12 months||||mm3||95% Confidence Interval|Mean
2688874|NCT01330966|Secondary|Overall Survival (OS)|The time origin for OS will be cycle 1 day 1. Subjects will be followed until 6 months after end of treatment, lost to follow-up, or withdrawal of consent. No upper limits of duration of assessment are identified or defined in the protocol.|Cycle 1 day 1 until 6 months after end of treatment, is lost to follow-up, or withdraws consent||||months||95% Confidence Interval|Median
2688875|NCT01330966|Secondary|Progression Free Survival (PFS)|The time origin for PFS will be cycle 1 day 1. Repeat radiologic imaging will be conducted after every 2 cycles of treatment (approximately every 8 weeks). No upper limits of duration of assessment are identified or defined in the protocol.|Cycle 1 day 1 until the subject experiences disease progression||||months||95% Confidence Interval|Median
2688876|NCT01330966|Primary|Disease Control at Week 16|Disease control at week 16 defined as complete response (CR), Disappearance of all target lesions; plus partial response (PR), At least a 30% decrease in the sum of diameters of the target lesions taking as reference the Baseline sum diameters; plus stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum diameters while on the study; where tumor response is defined by RECIST (Response Evaluation Criteria in Solid Tumors) guidelines version 1.1. Repeat radiologic imaging is performed after every 2 cycles of treatment (approximately every 8 weeks).|Assessed at week 16 of study treatment|Tumor responses were evaluable in 42 out of 47 patients; 5 patients discontinued prior to the first tumor assessment.|||Percentage of CR+PR+SD||95% Confidence Interval|Number
2688877|NCT01330953|Secondary|Number of Participants Forming Antibody to LY2928057||Baseline through Day 85|The analysis population included all randomized participants who received at least 1 dose of LY2928057 and antibody titer results.|||participants|||Number
2688878|NCT01330953|Secondary|Change From Baseline in Serum Iron|Maximum change from baseline to any point over 22 days post-infusion.|Baseline, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15 and 22|The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided plasma data for measuring serum iron levels as the primary pharmacodynamic analysis.|||microgram per deciliter (µg/dL)||Standard Deviation|Mean
2688879|NCT01330953|Secondary|Pharmacokinetics, Terminal Half-Life (t1/2)||Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85|The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic t1/2 analyses.|||days||Full Range|Geometric Mean
2688880|NCT01330953|Secondary|Pharmacokinetics, Volume of Distribution (V)|V=LY2928057 steady-state volume of distribution (Vss)|Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85|The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic Vss analyses.|||L||Geometric Coefficient of Variation|Geometric Mean
2688881|NCT01330953|Secondary|Pharmacokinetics, Systemic Clearance (CL)|CL=total body clearance of LY2928057 calculated after intravenous administration. Systemic CL was derived from LY2928057 serum concentration data following intravenous administration using classical non compartmental analysis (WinNonlin version 5.3).|Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85|The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic systemic CL analyses.|||liter per hour (L/h)||Geometric Coefficient of Variation|Geometric Mean
2688882|NCT01330953|Secondary|Pharmacokinetics, Time to Maximum Concentration (Tmax)||Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85|The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic tmax analyses.|||hour (h)||Full Range|Median
2688883|NCT01330953|Secondary|Pharmacokinetics, Maximum Concentration (Cmax)||Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85|The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic Cmax analyses.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2689008|NCT01329978|Primary|Percentage of Participants Who Experienced Adverse Events|Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.|Baseline (Day 1) to post-treatment Day 30|Safety Analysis Set|||percentage of participants|||Number
2688885|NCT01330953|Primary|Number of Participants With Clinically Significant Adverse Effects|A clinically significant effect/event was defined as an adverse event (AE). A listing of serious and non-serious AEs is located in the Reported Adverse Event Module.|Baseline through Day 85|The analysis population included all randomized participants dosed with placebo or LY2928057, and who provided safety data at least up to and including the Day 8 assessment.|||participants|||Number
2688886|NCT01330914|Secondary|Trabecular Number at the Tibia|Trabecular number at the tibia by high-resolution peripheral quantitative computed tomography (HR-pQCT). The 12-month change is the percentage change between the 12 month and baseline time points. HR-pQCT images were analyzed using the manufacturer's standard clinical evaluation protocol, with trabecular structure extracted using a threshold-based binarization process.|12 months post-operatively (between baseline and 12 months)|participants who underwent HR-pQCT at pre-op and 12-month post-op time points|||percent of baseline value||Standard Deviation|Mean
2688887|NCT01330914|Secondary|Areal Bone Mineral Density (BMD) at the Femoral Neck|Areal BMD at the femoral neck by dual-energy X-ray absorptiometry (DXA). The 12-month change is the percentage change between the 12 month and baseline time points.|12 months post-operatively (between baseline and 12 months)|participants who underwent DXA at pre-op and 12-month post-op time points|||percent of baseline value||Standard Deviation|Mean
2688888|NCT01330914|Primary|Change in Intestinal Calcium Absorption|"Change in fractional calcium absorption, determined by dual stable isotope method.~Fractional calcium absorption is the fraction of ingested calcium that is absorbed, which is expressed here as the percentage of ingested calcium that is absorbed. The 6-month change is the mean difference in percentage absorption between time points. For example, if fractional calcium absorption were to decrease from 30% preoperatively to 25% at the 6-month postoperative time point, the change in fractional calcium absorption would be -5%."|6 months (between baseline and 6 months)|Participants from the cohort who underwent assessment of fractional calcium absorption preoperatively and 6 months postoperatively|||% of ingested calcium that is absorbed||Standard Deviation|Mean
2688889|NCT01330628|Primary|Freedom From Major Adverse Events (MAE)|Number of participants free from Major Adverse Events (MAE) at 30 days. MAE are defined all cause death, major amputation in the target limb, or target lesion revascularization (TLR) from procedure to 30 days (±7 days).|30 days|The number of participants analyzed for this endpoint does not match with the Participant Flow 30 Day Follow-up population. If a subject did not complete a 30 Day Follow-up due to missing the visit or lost to follow-up, but had an MAE prior to this time point, they would still be included in this outcome analysis.|||# of participants free from MAE|||Number
2688890|NCT01330628|Primary|Freedom From Target Lesion Revascularization (TLR)|Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.|6 months|The number of participants analyzed for this endpoint does not match with the Participant Flow 6 Month Follow-up population. A subject may not complete a 6 Month Follow-up due to missing the visit, being lost to follow-up, etc., but if they had a TLR prior to this time point, they would still be included in this outcome analysis.|||# of participants free from TLR|||Number
2688891|NCT01330459|Secondary|Need for Additional Intraoperative and/or Postoperative Pain Medication|To assess need for additional intraoperative and/or postoperative pain medication|30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)||||Participants|||Count of Participants
2688892|NCT01330459|Secondary|Postoperative Nausea|To assess whether HC/APAP is associated with nausea, measured on the 100 mm VAS, recorded 30 minutes postoperatively. VAS anchors: 0 indicates no pain, and 100 indicates worst pain imaginable.|30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)||||mm||Standard Deviation|Mean
2688893|NCT01330459|Secondary|Satisfaction With Pain Control|Distance (mm) from the left of the 100 mm VAS (VAS anchors: 0 = unsatisfied, 100 mm = very satisfied) recorded 30 minutes after completion of the procedure.|30 minutes after completion of the procedure (which started 45-90 minutes after study drug administration)||||mm||Standard Deviation|Mean
2688894|NCT01330459|Secondary|Patient Perception of Pain During Cervical Dilation|Distance (mm) from the left of the 100 mm VAS scale (VAS anchors: 0 = none, 100 mm = worst imaginable) recorded after cervical dilation|During procedure (approximately 45-90 min after hydrocodone/acetaminophen or placebo, and within 5 minutes of procedure starting)||||mm||Standard Deviation|Mean
2688895|NCT01330459|Primary|Patient Perception of Pain|To determine whether HC/APAP, given in addition to a standard regimen of ibuprofen, lorazepam, and PCB, affects patient pain perception at the time of uterine aspiration, as measured by distance (mm) from the left of the 100 mm visual analog scale (VAS). The number 0 indicates no pain, and 100 indicates worst pain imaginable.|At time of uterine aspiration (baseline)||||mm||Standard Deviation|Mean
2688896|NCT01330433|Secondary|Hospital Stay|Number of days post surgery.|Length of stay after second surgery up to 1 month|The difference in the number of participants analyzed and the total number of participants is due to feeding issues unrelated to the surgery or the device that required the subject to remain hospitalized longer than anticipated.|||days||Standard Deviation|Mean
2688897|NCT01330433|Primary|Adhesion Burden|Skin to bypass time as an indicator of adhesion burden.|Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes)||||minutes||Standard Deviation|Mean
2688898|NCT01330433|Primary|Post-operative Bleeding|Post-operative bleeding through surgical site drainage output.|Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery|The difference in the number of participants analyzed and the total number of participants is due to the information not being properly collected at the time of the surgery. Because there was a lack of confidence in the data, it was discarded.|||cm^3||Standard Deviation|Mean
2688899|NCT01330433|Primary|Severity of Adhesions at the Right Lateral Site|Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery||||percentage of participants|||Number
2694332|NCT01287416|Secondary|Lifetime Suicide Attempt at Baseline|Number of people who endorsed having made a suicide attempt in their lifetime as measured at baseline|July 19-20, 2010||||participants|||Number
2688900|NCT01330433|Primary|Severity of Adhesions at the Left Lateral Site|Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery||||percentage of participants|||Number
2688901|NCT01330433|Primary|Severity of Adhesions at the Diaphragm Site|Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery||||percentage of participants|||Number
2688902|NCT01330433|Primary|Severity of Adhesions at the Arterial Base Site.|Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery||||percentage of participants|||Number
2688903|NCT01330433|Primary|Severity of Adhesions at the Retrosternal Site|Severity of adhesions at seven predefined sites (pericardial or retrosternal, inferior or diaphragmatic region, right lateral or arterial region, region around great vessels). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).|Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery||||percentage of participants|||Number
2688904|NCT01330420|Secondary|The Health Promoting Lifestyle Profile II (HPLP-II)|"The Health Promoting Lifestyle Profile II (HPLP-II) was used to assess health promoting behaviors. Based on the Health Promoting Model (Pender, 1982) this 52-item instrument measures self-initiated health behaviors that serve to maintain or enhance the level of self-actualization and wellness. Included are subscales for physical activity, spiritual growth, health responsibility, interpersonal relations, nutrition, and stress management. It is self-administered and uses a 4-point response format. Both English and Spanish versions are available.~A score for overall health-promoting lifestyle is obtained by calculating a mean of the individual's responses to all 52 items; six subscale scores are obtained similarly by calculating a mean of the responses to subscale items. Scores range from 1 = Never to 4 = Routinely, with a higher score corresponding to a more health promoting lifestyle."|comparison pre program initiation and post program completion time points (6 weeks)|24 patients met completer status, defined as patients who attended all or part of the six sessions. Not all 24 patients had complete pre-/post-intervention questionnaires sets. Therefore, patients may have missed some of the questionnaires, either pre- or post-intervention, and thus the number of patients analyzed maybe less than 24.|||units on a scale||Standard Deviation|Mean
2688905|NCT01330420|Primary|Satisfaction With Care (PSQ-18)|Patient Satisfaction Questionnaire Short Form (PSQ-18) takes approximately 3-4 minutes to complete, containing 18 items examining seven dimensions of satisfaction with medical care: general satisfaction (2 questions, Mean =3.58, SD =0.94), technical quality (3 questions, Mean = 3.68, SD = 0.76), interpersonal manner (2 questions, Mean = 4.09, SD = 0.69), communication (2 questions, Mean = 3.74, SD = 0.87), financial aspects (2 questions, Mean = 3.78, SD = 0.94), time spent with doctor (2 questions, Mean = 3.59, SD = 0.94), and accessibility and convenience (4 questions, Mean = 3.76, SD = 0.74). Responses to each item are given on a 5-point scale ranging from 1 - strongly agree to 5 - strong disagree, therefore higher scores correspond to less satisfaction. PSQ-18 subscale scores are substantially correlated with their full-scale counterparts and possess generally adequate internal consistency reliability.|comparison pre program initiation and post program completion time points (6 weeks)|24 patients met completer status, defined as patients who attended all or part of the six sessions. Not all 24 patients had complete pre-/post-intervention questionnaires sets. Therefore, patients may have missed some of the questionnaires, either pre- or post-intervention, and thus the number of patients analyzed maybe less than 24.|||units on a scale||Standard Deviation|Mean
2688906|NCT01330420|Primary|Quality of Life (QOL-5)|The QOL-5 is a short, global, and generic quality of life (QoL) questionnaire for clinical databases. The QOL-5 item tool is used to compare various population groups using generic factors common to people everywhere irrespective of age, sex, culture, and state of health. Scores on the QOL-5 ranges from 0 = lowest quality to 100 = highest quality.|comparison pre program initiation and post program completion time points (6 weeks)||||units on a scale||Standard Deviation|Mean
2688907|NCT01330420|Primary|Health Status (SF-12)|The SF-12 was used to assess health status. It is the shortened version of the well-validated SF-36, directed at monitoring overall physical and mental health outcomes. It is available in both English and Spanish. Scoring algorithms involve weighted-item responses, all 8 scales to use the same standardization for easy comparison. All scores range from 0-100 where higher scores indicated better QOL. The mean = 50 and the SD = 10.|comparison pre program initiation and post program completion time points (6 weeks)|24 patients met completer status, defined as patients who attended all or part of the six sessions. Not all 24 patients had complete pre-/post-intervention questionnaires sets. Therefore, patients may have missed some of the questionnaires, either pre- or post-intervention, and thus the number of patients analyzed maybe less than 24.|||units on a scale||Standard Deviation|Mean
2688926|NCT01330381|Secondary|Stool Consistency Per SBM Score in Children With Diapers in the Double-Blind Treatment Period|Measured on a 4-point scale where 1 is constipation, 2-3 is ideal, and 4 is diarrhea.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||units on a scale||Standard Deviation|Mean
2688908|NCT01330420|Primary|Depression Severity (CEDS-10)|The Center for Epidemiologic Studies Depression Scale (CES-D 10) was used to assess depression severity pre-and post-intervention. This is the shorter 10-item, modified version of the 20-item CES-D. The total score is the sum of the 10 item weights, with the lowest possible score being 0 and the highest possible score being 30, and a higher score indicating more depressive symptoms. Developed from other well-validated depression scales, this instrument measures the experience of depressive symptoms over the past week. This instrument is shown to be better than the CES-D 20 in combining data from different ethnic and cultural groups, and is available in both English and Spanish. This scale has been reported to have good internal consistency and validity.|comparison pre program initiation and post program completion time points (6 weeks)|24 patients met completer status, defined as patients who attended all or part of the six sessions.|||units on a scale||Standard Deviation|Mean
2688909|NCT01330394|Secondary|Effort to Control the Urge for Use Alcohol|Obsessive Compulsive Drinking Scale will be applied before and after ERP procedures|one year and a half|||||||
2688910|NCT01330394|Secondary|Quality of Life|Quality of life scale will be applied at the end of the protocol|one year and a half|||||||
2688911|NCT01330394|Secondary|Cognitive Tasks|Cognitive tests comprised by Frontal Assessment Battery (FAB), verbal n-back task, visuospatial n-back task, go-no-go task, counting Stroop, will be done at the beginning of the session 1 and session 6 (one week after the 5 sessions of sham or tDCS).|one year and a half|||||||
2688912|NCT01330394|Secondary|Event-related Potentials|Event-related potential (ERPs) was recorded under the presentation of 120 sounds [60 of 3 types related to the use of alcoholic beverages (open a can of beer, fill a glass of beer, opening and fall of the lid of a bottle of beer), and 3 types of 60 neutral sounds (open a door, typing a keyboard, shower water)] lasted for 384 s for each period before and after transcranial Direct Current Stimulation|one year and a half|||||||
2688913|NCT01330394|Primary|Use of Alcohol|Relapse to the use of alcohol to a usual pattern observed before treatment (for example, if a patient was used to have 10 drinks/day before treatment and start to have about this amount of drinks/day with similar behavior seen before treatment, it would be considered a relapse).|6 months after treatment||||participants|||Number
2688914|NCT01330381|Secondary|Convenience of Treatment for Final On Treatment Assessment in Open-Label Treatment Period||Over the 16 week open label treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||percentage of subjects|||Number
2688915|NCT01330381|Secondary|Efficacy of Treatment for Final On Treatment Assessment in Open-Label Treatment Period||Over the 16 week open label treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||percentage of subjects|||Number
2688916|NCT01330381|Secondary|Efficacy of Treatment for Final On Treatment Assessment in Double-Blind Treatment Period||Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||percentage of subjects|||Number
2688917|NCT01330381|Secondary|Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Open-Label Treatment Period||2 weeks|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||percentage of subjects|||Number
2688918|NCT01330381|Secondary|Severity of Constipation Over the Past 2 Weeks for the Final On Treatment Assessment in the Double-Blind Treatment Period||2 weeks|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||percentage of subjects|||Number
2688919|NCT01330381|Secondary|Change From Baseline in the Number of SBM Per Week Over the 8 Week Double Blind Treatment Period||Baseline and over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||SBM/week||Standard Deviation|Mean
2688920|NCT01330381|Secondary|Number of SBM Per Week in the Double-Blind Treatment Period||Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||SBM/week||Standard Deviation|Mean
2688921|NCT01330381|Secondary|Time to First SBM in the Double-Blind Treatment Period|After intake of the trial medication on Day 1.|Day 1 onwards|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product.|||hours||95% Confidence Interval|Median
2688922|NCT01330381|Secondary|Number of Rescue Medications Taken in the Double-Blind Treatment Period||Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||rescue medications/week||Standard Deviation|Mean
2688923|NCT01330381|Secondary|Frequency of Toilet Training in the Double-Blind Treatment Period|Only for subjects after acquisition of toileting skills.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||toilet trainings/week||Standard Deviation|Mean
2688924|NCT01330381|Secondary|Abdominal Pain Score in Double-Blind Treatment Period|Pain was rated on a 6-point scale (0=no hurt, 1=hurts little bit, 2=hurts little more, 3=hurts even more, 4=hurts whole lot, 5=hurts worst) in subjects of 3 years and older. Lower scores represent less pain.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||units on a scale||Standard Deviation|Mean
2688925|NCT01330381|Secondary|Large Diameter Stools in the Double-Blind Treatment Period|Large diameter stools make defecation more difficult. Small diameter stools are better.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||large diameter stools/week||Standard Deviation|Mean
2688927|NCT01330381|Secondary|Stool Consistency Per SBM Score in Children Without Diapers in the Double-Blind Treatment Period|Measured using the 7-point Bristol scale where 1-2 indicate constipation, 3-4 are ideal stools, and 5-7 tending toward diarrhea.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||units on a scale||Standard Deviation|Mean
2688928|NCT01330381|Secondary|Painful Bowel Movements Score in the Double-Blind Treatment Period|Pain was rated on a 6-point scale (0=no hurt, 1=hurts little bit, 2=hurts little more, 3=hurts even more, 4=hurts whole lot, 5=hurts worst) in subjects of 3 years and older. Lower scores represent less pain.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||units on a scale||Standard Deviation|Mean
2688929|NCT01330381|Secondary|Number of Retentive Posturing or Excessive Volitional Stool Retention in the Double-Blind Treatment Period|Purposefully avoiding defecation.|Over the 8 week double blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||retentions/week||Standard Deviation|Mean
2688930|NCT01330381|Secondary|Percent of Subjects With Fecal Incontinence Episodes of 1 or Less Per 2 Weeks in the Last Four Weeks of the Double-Blind Treatment Period|Fecal incontinence is a lack of control over defecation, leading to involuntary loss of bowel contents (only for subjects after acquisition of toileting skills).|Last 4 weeks of double-blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product. Not all subjects in the Full Analysis Set had data for this outcome.|||percentage of subjects|||Number
2688931|NCT01330381|Secondary|Percent of Subjects With Bowel Frequency of 3 or More Spontaneous Bowel Movements (SBM) Per Week in the Last Four Weeks of the Double-Blind Treatment Period|Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.|Last 4 weeks of double-blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product.|||percentage of subjects|||Number
2688932|NCT01330381|Primary|Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period|Responders are defined as subjects with an average spontaneous defecation frequency is ≥3 times per week AND the average number of fecal incontinence episodes per 2 weeks is ≤ 1 episode (only for subjects after acquisition of toileting skills).|Last 4 weeks of double-blind treatment period|Full Analysis Set includes all subjects who were randomized and received at least 1 dose of investigational product.|||percentage of subjects|||Number
2688933|NCT01330355|Secondary|Microbial Outcome|"Microbial outcome for the following groups of accepted ocular bacterial species that were present at or above threshold at baseline:~over all bacterial species~over all and individual gram-positive bacterial species~over all and individual gram-negative bacterial species"|Visit 3 (Day 3) and Visit 5 (Day 8+1)|The analysis population only includes those for whom the outcome was measured within the specified time frame. A subject may have tested positive for multiple bacterial species (up to 5 species).|||events|||Number
2688934|NCT01330355|Secondary|Microbial Eradication|Eradication defined as the absence of all accepted ocular bacterial species (as measured on the ordinal scale) that were present at or above threshold at baseline|Visit 5 (Day 8+1)|The analysis population only includes those for whom the outcome was measured within the specified time frame.|||participants|||Number
2688935|NCT01330355|Secondary|Clinical Resolution|Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.|Visit 3 (Day 3)|The analysis population only includes those for whom the outcome was measured within the specified time frame.|||participants|||Number
2688936|NCT01330355|Primary|Clinical Resolution|Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.|Visit 5 (Day 8+1)|The analysis population only includes those for whom the outcome was measured within the specified time frame.|||participants|||Number
2688937|NCT01330316|Secondary|Changes From Baseline in Laboratory Test Values Over Time [Bilirubin Total]|"This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.~In this outcome measure Bilirubin total is presented."|baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)|FAS|||milligram (mg)/dL||Standard Deviation|Mean
2688938|NCT01330316|Secondary|Changes From Baseline in Laboratory Test Values Over Time [AST]|"This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.~In this outcome measure AST is presented."|baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)|FAS|||U/L||Standard Deviation|Mean
2688939|NCT01330316|Secondary|Changes From Baseline in Laboratory Test Values Over Time [ALT]|"This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.~In this outcome measure ALT is presented."|baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)|FAS|||Units (U)/Litre (L)||Standard Deviation|Mean
2688997|NCT01329978|Secondary|Percentage of Participants With ALT Normalization at Week 12|ALT normalization was defined as ALT > ULN at baseline and ALT ≤ ULN at Week 12.|Baseline (Day 1) to Week 12|Participants in the Safety Analysis Set with ALT > ULN at baseline and with available data were analyzed.|||percentage of participants|||Number
2712972|NCT01152385|Primary|Change in Haemoglobin A1c (HbA1c)||from baseline to 4 months|The analysis population was prior to rescue treatment (FAS)|||Percentage||Standard Deviation|Mean
2688940|NCT01330316|Secondary|Changes From Baseline in Laboratory Test Values Over Time [Haemoglobin]|"This outcome measure will be presented as the mean value and the standard deviation at baseline, week 4, week 12, the minimum (min) value on treatment, maximum (max) value on treatment and last measured value on treatment. Analytes with particular relevance for patients with HCF have been selected: Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total.~In this outcome measure Haemoglobin is presented."|baseline (the last observed measurement prior to administration of any randomised study medication), week 4, week 12 (after start of treatment)|FAS|||gram (g)/decilitre (dL)||Standard Deviation|Mean
2688941|NCT01330316|Secondary|Laboratory Test Abnormalities by DAIDS Grades|This Outcome measure will be presented as summary of the percentage of patients with worst on-treatment Division of Acquired Immunodeficiency Syndrome (DAIDS) grade laboratory abnormalities for selected analytes (Haemoglobin, Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST) and Bilirubin total) with particular relevance to patients with HCV.|baseline (day 1, after first dose of randomised treatment) up to 7 days after the last intake of study|FAS|||percentage of participants|||Number
2688942|NCT01330316|Secondary|Occurrence of Drug-related AEs as Assessed by the Investigator|This outcome measure will be presented as the percentage of subjects with any drug-related AEs as assessed by the investigator. Percentages are calculated using total number of subjects per treatment cohort as the denominator.|from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days|FAS|||percentage of participants|||Number
2688943|NCT01330316|Secondary|Occurrence of Serious Adverse Events (SAEs)|This outcome measure will be presented as the percentage of subjects with any serious adverse event (SAE). Percentages are calculated using total number of subjects per treatment cohort as the denominator.|from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days|FAS|||percentage of participants|||Number
2688944|NCT01330316|Secondary|Occurrence of Adverse Events Leading to Treatment Discontinuation|This outcome measure will be presented as the percentage of subjects with adverse events leading to discontinuation of Faldaprevir and all study medication. Percentages are calculated using total number of subjects per treatment cohort as the denominator.|from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days|FAS|||percentage of participants|||Number
2688945|NCT01330316|Secondary|Occurrence of Adverse Events (Overall and by DAIDS Grade)|"This outcome measure will be presented as the percentage of subjects with any adverse event (AE).~Percentages are calculated using total number of subjects per treatment cohort as the denominator.~The intensity of all AEs was evaluated according to the DAIDS (Division of Acquired Immunodeficiency Syndrome) grading scale with AEs of mild, moderate, or severe intensity receiving Grades 1, 2, or 3, respectively. Adverse events judged potentially life threatening received a Grade 4 assessment."|from first intake of study medication until 30 days after discontinuing faldaprevir, up to a maximum of 213 days|FAS|||percentage of participants|||Number
2688946|NCT01330316|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at 12 Weeks Post-treatment.|This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.|Week 48 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers|FAS|||participants|||Number
2688947|NCT01330316|Secondary|Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EoT)|This will be presented as the number of patients in/not in normal range from baseline to EoT. SVR12 is sustained virological response 12 weeks post-treatment.|Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers.|FAS|||participants|||Number
2688948|NCT01330316|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at 12 Weeks Post-treatment.|This will be presented as the number of patients in/not in normal range from baseline to 12 weeks post treatment. SVR12 is sustained virological response 12 weeks post-treatment.|48 weeks for relapsers with ETS; 60 weeks for non-relapsers and relapsers without ETS|FAS|||participants|||Number
2688949|NCT01330316|Secondary|Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EoT)|This will be presented as the number of patients in/not in normal range from baseline EoT. SVR12 is sustained virological response 12 weeks post-treatment.|Week 24 for relapsers with ETS; Week 48 for relapsers without ETS, and non-relapsers|FAS|||participants|||Number
2688950|NCT01330316|Secondary|Early Treatment Success (ETS)|ETS, defined as a plasma HCV RNA level <25 IU/mL (detected or undetected) at week 4 and HCV RNA <25 IU/mL (undetected) at week 8.|week 4 and week 8|FAS|||percentage of participants|||Number
2688951|NCT01330316|Secondary|Sustained Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)|Sustained virologic response 24 weeks, defined as a plasma HCV RNA level < 25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.|24 weeks post treatment, up to 72 weeks|FAS|||percentage of participants||95% Confidence Interval|Number
2688952|NCT01330316|Primary|Sustained Virological Response (SVR): Plasma HCV RNA Level < 25 IU/mL|The primary endpoint was SVR12, defined as a plasma Hepatitis C virus (HCV) Ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.|12 weeks post treatment, up to 60 weeks|FAS|||percentage of participants||95% Confidence Interval|Number
2688953|NCT01330303|Primary|Cmax|"Cmax is defined as the maximum or peak concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed."|Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2)|Participants who completed the study|||ng/ml||Standard Deviation|Mean
2688954|NCT01330303|Primary|AUC0-infinity|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.|Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2)|Participants who completed the study|||ng.h/ml||Standard Deviation|Mean
2694333|NCT01287416|Secondary|Lifetime Suicidal Ideation at Baseline|Number of people who endorsed having thought about suicide in their lifetime as measured at baseline|July 19-20, 2010||||participants|||Number
2688955|NCT01330303|Primary|AUC 0-t|The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.|Day 1 (day that blood collections started) to Day 4 (Period 1) and Days 8 to 11 (Period 2)|Participants who completed the study|||ng per hour per ml (ng.h/ml)||Standard Deviation|Mean
2688956|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Care-giving Efforts|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
2688957|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
2688958|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
2688959|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
2688960|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
2688998|NCT01329978|Secondary|Percentage of Participants With HCV RNA Below < LOD at Week 24||Week 24|Participants in the Safety Analysis Set with Available data were analyzed. No participants in the SOF+PEG+RBV 12 weeks group were analyzed because they received only 12 weeks of treatment.|||percentage of participants|||Number
2688999|NCT01329978|Secondary|Percentage of Participants With HCV RNA Below < LOD at Week 12||Week 12|Participants in the Safety Analysis Set with Available data were analyzed.|||percentage of participants|||Number
2688961|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
2688962|NCT01330290|Secondary|Score for the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
2688963|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Resorption|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
2688964|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Risk of Interaction With Other Treatments|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
2688965|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Sleeping Patients|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
2688966|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication With Regard to Independency of Food Administration|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
2689000|NCT01329978|Secondary|Percentage of Participants With HCV RNA Below < LOD at Week 8||Week 8|Participants in the Safety Analysis Set with Available data were analyzed.|||percentage of participants|||Number
2688967|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dose Adaption|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
2688968|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Surgery Requiring General Anaesthesia|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
2688969|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Multiple Medication in Patients With Multiple Medication|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
2688970|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Control of Compliance|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
2688971|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Nausea and/or Vomiting in Patients With Nausea and/or Vomiting.|"This individual question from the physicians' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
2688972|NCT01330290|Secondary|Score for the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication in Relation to Dysphagia in Patients With Dysphagia|"This individual question from the caregivers' questionnaire was to be assessed from major disadvantages to major advantages, and the corresponding answer was to be evaluated according to a 5-point rating scale using a score from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
2689001|NCT01329978|Secondary|Percentage of Participants With HCV RNA Below < LOD at Week 4||Week 4|Participants in the Safety Analysis Set with Available data were analyzed.|||percentage of participants|||Number
2688973|NCT01330290|Secondary|Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Application Form in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support|"The physician was asked if he / she prescribed Neupro® due to application form in idiopathic Parkinson's Disease patients requiring caregiver support. The possible answers were applicable and not applicable."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires.|||participants|||Number
2688974|NCT01330290|Secondary|Assessment of the Physicians' Rationale for the Choice of Neupro® Due to Substance in Idiopathic Parkinsons Disease Patients Requiring Caregiver Support|"The physician was asked if he / she prescribed Neupro® due to substance in idiopathic Parkinson's Disease patients requiring caregiver support. The possible answers were applicable and not applicable."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires.|||participants|||Number
2688975|NCT01330290|Primary|Mean Score of the Physicians' Rating of Neupro® Compared to Oral Anti-Parkinson Medication|"The physicians were asked to fill out a questionnaire composed of 10 questions covering medical and caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2.~Each physician could have assessed one or multiple participants. The scores from each physician were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the physicians."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct physician was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
2688976|NCT01330290|Primary|Mean Score of the Caregivers' Rating of Neupro® Compared to Oral Anti-Parkinson Medication|"The caregivers were asked to fill out a questionnaire composed of 7 questions covering caregiving aspects. The mean score is calculated from the scores for the single responses which are rated from 'great disadvantages' to 'great advantages' and scored on a 5-point scale from -2 to +2.~Each caregiver could have assessed one or multiple participants. The scores from each caregiver were averaged over all participants they assessed, and the final mean score was calculated from the averaged assessments of the caregivers."|Questionnaire completed at a single time-point during the run of the cross-sectional study (16 months). Suitable patients suffer from idiopathic iPD treated with a combination of l-dopa or another oral iPD drug and Neupro® for at least one month.|The Analysis Population refers to the Full Analysis Set (FAS). The Full Analysis Set (FAS) comprises all patients with at least 1 assessment in the physicians' or caregivers'/nurses' questionnaires. The average assessment of all patients assessed by a distinct caregiver was calculated and used for analysis.|||units on a scale|Participants|Standard Deviation|Mean
2688977|NCT01330134|Secondary|Pain Assessment: During Procedure|visual analog scale (VAS) 0 = no pain to 100 = worse pain possible Rather, this is a pain assessment during the actual procedure rather than during the pre-procedure lidocaine injection.|post procedure (day 1)||||units on a scale||Standard Deviation|Mean
2688978|NCT01330134|Secondary|Pain Assessment: Lidocaine Injection|visual analog scale (VAS) 0= no pain to 100 = worse pain possible|post procedure (day 1)||||units on a scale||Standard Deviation|Mean
2688979|NCT01330134|Primary|Pain Assessment: Overall|Visual analog scale (VAS). This is a standardized analog scale with scores from 0-100. It measures level of pain with 0 meaning no pain and 100 meaning the most extreme level of pain. Higher values refer to a worse outcome.|post procedure (day 1)||||units on a scale||Standard Deviation|Mean
2688980|NCT01330108|Secondary|Mean Change in Distance for a Six Minute Walk at 12 Weeks Post Start of Ambrisentan|Evaluate the change in exercise tolerance. Measured the distance a subject was capable of walking in 6 minutes at basline compared to the distance at 12 weeks. The distance was measured in meters. A postive result reflects the distance increased at 12 weeks, a negative result reflects how much shorter the distance was.|baseline to 12 weeks||||meters||Full Range|Mean
2688981|NCT01330108|Primary|Number of Subjects Not Able to Tolerate Ambrisentan|If a subject was not able tolerate ambrisentan, subject was returned to use of bosentan and ambrisentan was withdrawn within first 12 weeks of start. A subject was considered to not be able to tolerate ambrisentan if they experienced an adverse event or side effect that was not acceptable to the subject.|baseline to 12 weeks||||participants|||Number
2688982|NCT01330043|Secondary|Expired-air CO Verified Point-prevalence Abstinence|Self-reported no smoking in last 7 days verified by CO<10 ppm|104 weeks||||participants|||Number
2688983|NCT01330043|Primary|Expired-air CO Verified Point-prevalence Abstinence|Self-reported no smoking in last 7 days verified by CO<10 ppm|52 weeks||||participants|||Number
2688984|NCT01330030|Primary|Expired-air Carbon Monoxide Confirmed Smoking Abstinence|expired-air carbon monoxide confirmed smoking abstinence at 52 weeks|52 weeks|intention to treat|||participants not smoking|||Number
2688985|NCT01330017|Secondary|Change From Baseline for the Instantaneous Nasal Symptom Assessment Score at Day 7|The magnitude of effect was measured as the change from baseline for the instantaneous nasal symptom assessment score at Day 7. Instantaneous assessment of nasal symptoms was performed once daily before the morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.|Baseline, Day 7|The ITT population included all randomized participants who received at least 1 dose of study medication.|||Units on a Scale||Standard Deviation|Mean
2689002|NCT01329978|Secondary|Percentage of Participants With HCV RNA < LOD at Week 2||Week 2|Participants in the Safety Analysis Set with Available data were analyzed.|||percentage of participants|||Number
2688986|NCT01330017|Secondary|Time to Maximal Effect|Time to maximal effect is defined as the earliest time that the nasal congestion symptom score demonstrates the greatest numerical difference from the placebo in change from baseline. The mean change from baseline scores for a treatment arm and for the placebo arm at each day and timepoint of the treatment period (Day 1 morn, Day 1 eve, etc) were calculated. Then the difference between the placebo and treatment arm means at each day/timepoint of the treatment period was calculated and recorded the day/timepoint that the difference between the treatment arm and the placebo was highest.|Baseline up to Day 7|The ITT population included all randomized participants who received at least 1 dose of study medication.|||Days|||Number
2688987|NCT01330017|Secondary|Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period|"Instantaneous assessment of nasal symptoms was performed once daily before the~morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms."|Baseline and Days 1, 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.|||Units on a Scale||Standard Deviation|Mean
2688988|NCT01330017|Secondary|Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period|The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period.|Baseline and Days 1, 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.|||Units on a Scale||Standard Deviation|Mean
2688989|NCT01330017|Secondary|Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period|"Instantaneous assessment of nasal symptoms was performed once daily before the~morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms."|Baseline and Day 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.|||Units on a Scale||Standard Deviation|Mean
2688990|NCT01330017|Secondary|Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period|The evening reflective nasal congestion score was captured in participant diaries just before the 8;00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.|Baseline and Days 1, 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.|||Units on a Scale||Standard Deviation|Mean
2688991|NCT01330017|Secondary|Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period|The morning reflective nasal congestion score was captured in participant diaries just before the 8:00 am dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and it is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.|Baseline and Days 2, 3, 4, 5, 6, and 7|The ITT population included all randomized participants who received at least 1 dose of study medication.|||Units on a Scale||Standard Deviation|Mean
2688992|NCT01330017|Primary|Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score|The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. Participants rated congestion on a 4-point scale of severity from 0 (best) to 3 (worst), with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. Baseline was defined as the average of the daily scores over the 4 consecutive 24-hour periods before randomization.|Baseline, Day 7|The Intent-to-Treat (ITT) population included all randomized participants who received at least 1 dose of study medication.|||Units on a Scale||Standard Deviation|Mean
2688993|NCT01329978|Secondary|Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse).|Viral relapse was defined as HCV RNA < 15 IU/mL at end of treatment, confirmed with 2 consecutive values or last available measurement.|End of treatment to Post-treatment Week 24|Participants in the Safety Analysis Set with available data were analyzed.|||percentage of participants|||Number
2688994|NCT01329978|Secondary|Percentage of Participants With Virologic Failure During Treatment|"Virologic failure was defined as either~HCV RNA ≥ 15 IU/mL after having previously had HCV RNA < 15 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement (ie, breakthrough);~> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement (ie, rebound);or~HCV RNA persistently ≥ 15 IU/mL through 8 weeks of treatment (ie, nonresponse)~Baseline was Day 1 for all groups."|Baseline (Day 1) to Week 24|Safety Analysis Set|||percentage of participants|||Number
2688995|NCT01329978|Secondary|Percentage of Participants With ALT Normalization at Post-treatment Week 4|ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Post-treatment Week 4.|Baseline (Day 1) to Post-treatment Week 4|Participants in the Safety Analysis Set with ALT > ULN at baseline and with available data were analyzed.|||percentage of participants|||Number
2688996|NCT01329978|Secondary|Percentage of Participants With ALT Normalization at Week 24|ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Week 24.|Baseline (Day 1) to Week 24|Participants in the Safety Analysis Set with ALT > ULN at baseline and with available data were analyzed. No participants in the SOF+PEG+RBV 12 weeks group were analyzed because they received only 12 weeks of treatment.|||percentage of participants|||Number
2717747|NCT01117623|Secondary|Biomarker Vascular Endothelial Growth Factor (VEGF) Plasma Levels|The analysis of Biomarker VEGF plasma levels is not done|No data obtained|ITT||||||
2689009|NCT01329978|Primary|Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24)|SVR24 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 24 weeks after the last dose of study drug.|Post-treatment Week 24|Participants in the Safety Analysis Set (participants who were randomized and received at least 1 dose of study drug) with genotype 1 and who had available data were analyzed.|||percentage of participants||95% Confidence Interval|Number
2689010|NCT01329939|Secondary|Urinary Creatinine (Cr) Levels/Leukotriene E4 (LTE4) Ratio|The ratio of urinary LTE4 to Cr provides a standardization of the LTE4 level based on the patients weight and muscle mass, therefore normalizing it across the different subjects. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|One subject in the normal weight atopic asthmatic group who was receiving placebo did not provide a urine sample at 24 weeks.|||pg/mg||95% Confidence Interval|Mean
2689011|NCT01329939|Secondary|Urinary Creatinine (Cr) Levels|Creatinine, measured in the urine, reflects how well the kidneys are working, and provide a standard to which one can compare other metabolites in the urine. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|One subject in the normal weight atopic asthmatic group who was receiving placebo did not provide a urine sample at 24 weeks.|||mg/mL||95% Confidence Interval|Mean
2689012|NCT01329939|Secondary|Beclomethasone Equivalents|The total daily dose of inhaled corticosteroids in beclomethasone equivalents. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks||||micrograms||95% Confidence Interval|Mean
2689013|NCT01329939|Secondary|Exhaled Nitric Oxide Measurement|A non-invasive measure of eosinophilic airway inflammation. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks||||ppb||95% Confidence Interval|Mean
2689014|NCT01329939|Secondary|Urinary Leukotriene E4 (LTE4) Levels|LTE4 levels, measured in the urine, reflect the degree of inflammation in the asthmatic airway. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks|One subject in the normal weight atopic asthmatic group who was receiving placebo did not provide a urine sample at 24 weeks.|||pg/mL||95% Confidence Interval|Mean
2689015|NCT01329939|Secondary|Serum Leptin Levels|Leptin levels, measured through blood, mediate appetite and are elaborated by adipose tissue. Levels correlate positively with body fat percentage. In addition, leptin plays a role in producing an inflammatory state. Adiponectin, which is also secreted by adipose tissue, regulates metabolism, however its levels are inversely correlated with body fat percentage.|24 weeks||||ng/mL||95% Confidence Interval|Mean
2689016|NCT01329939|Secondary|Spirometric Measures|Breathing maneuvers which help to measure obstruction of airways. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks||||percent predicted||95% Confidence Interval|Mean
2689017|NCT01329939|Primary|Asthma Control Test (ACT) Scores|The ACT is a validated questionaire-based tool designed to assess asthma control. Scale range for 7-11 year olds is 0-27 and for 12 years and older 5-25, with lower scores indicating poorer asthma control for all ages. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.|24 weeks||||units on a scale||95% Confidence Interval|Mean
2689018|NCT01329848|Secondary|Conlon Symptom Survey|Measures visual discomfort symptoms while doing near work. 23 item survey using a 4-point rating scale (never, occasionally, often, almost always). Total raw score reported on a range from 0 to 69 with higher scores indicating more frequent symptoms.|3 weeks||||units on a scale||Standard Deviation|Mean
2689019|NCT01329848|Primary|Accommodation Lag 5D|Lag will be measured at different viewing distances and durations using autorefraction. Accommodation error refers to the difference between the distance where the target is located and where the eyes focus. Lag refers error that is under focussed; lead is error that is over focussed. This distance is measured in diopters, or 1/meter.|3 week period||||diopters||Standard Deviation|Mean
2689020|NCT01329679|Secondary|Max QTc Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7||At baseline and 7 days post energy drink and placebo consumption||||msec||Standard Deviation|Mean
2689021|NCT01329679|Secondary|Max QT Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7||At baseline and 7 days post energy drink and placebo consumption||||msec||Standard Deviation|Mean
2689022|NCT01329679|Secondary|Max QRS Duration After a Single Shot and After Chronic Consumption||At baseline and 7 days post energy drink and placebo consumption||||msec||Standard Deviation|Mean
2689023|NCT01329679|Secondary|Max PR-interval After a Single Shot and After Chronic Consumption||At baseline and 7 days post energy drink and placebo consumption||||msec||Standard Deviation|Mean
2689024|NCT01329679|Secondary|Max Heart Rate After a Single Shot and After Chronic Consumption||At baseline and 7 days post energy drink and placebo consumption||||beats per minute||Standard Deviation|Mean
2689025|NCT01329679|Secondary|Office DBP After a Single Energy Shot and After Chronic Consumption|Office diastolic blood pressure (DBP)|At baseline and 7 days post energy drink and placebo consumption||||mmHg||Standard Deviation|Mean
2689026|NCT01329679|Primary|Change in Office Systolic Blood Pressure|SBP = Systolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days.|At baseline and 7 days post energy drink and placebo consumption||||mmHg||Standard Deviation|Mean
2689043|NCT01329562|Primary|Time to Pain Free|"Duration of 1 menstrual migraine from time of treatment at menstrual migraine headache onset until pain free in Treximet vs. Placebo arms.~0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe."|From onset of 1 menstrual migraine headache until pain free.|In Group B, one subject did not report when their headache resolve, therefore a duration for this subject could not be calculated.|||hours||Standard Deviation|Mean
2717841|NCT01116882|Secondary|Any Repeat Revascularization||12 months||||participants|||Number
2689027|NCT01329562|Secondary|Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid-Luteal and at Menstrual Migraine Headache Free in Responders vs Non-Responders|"Correlation of mean estrogen levels in saliva and urine estradiol at mid-luteal, menstrual migraine headache onset* and at migraine headache free following treatment in responders vs. non-responders**.~*Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point.~***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From mid luteal phase and for the duration of 1 menstrual migraine until headache free.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||pg/mL||Standard Deviation|Mean
2689028|NCT01329562|Secondary|α-Amylase Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders|"α-Amylase levels collected for 1 menstrual migraine at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.~**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From Baseline from 24 hours post migraine gone for 1 menstrual migraine.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||U/L||Standard Deviation|Mean
2689029|NCT01329562|Secondary|CGRP Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders|"CGRP levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders**.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.~**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From Baseline to 24 hours post headache gone for 1 menstrual migraine.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||pmol/mg||Standard Deviation|Mean
2689030|NCT01329562|Secondary|Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders|"VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Responders vs Non-Responders***.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes.~***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment. A non-responder is one that fails to meet the responder criteria."|From Baseline for the duration of 1 menstrual migraine headache, an estimated 7 days|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||pg/mL||Standard Deviation|Mean
2689031|NCT01329562|Primary|Correlation of Mean Estrogen Levels in Saliva and Urine Estradiol at Mid Luteal and at Menstrual Migraine Headache Free.|"Correlation of mean estrogen levels in saliva and urine estradiol at mid luteal, menstrual migraine headache onset*, and at migraine headache free following treatment with Treximet vs. Placebo for 1 menstrual migraine headache~*Urine estradiol levels were not collected at migraine onset, therefore; correlations could not be completed for that time point."|From mid luteal phase and for the duration of 1 menstrual migraine headache and until headache free|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||pg/mL||Standard Deviation|Mean
2689032|NCT01329562|Primary|α-Amylase Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.|"α-Amylase levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure."|From baseline to 24 hours post headache gone for 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data.|||U/L||Standard Deviation|Mean
2689033|NCT01329562|Primary|CGRP Measured at Menstrual Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.|"CGRP levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache.~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure."|From baseline to 24 hours post headache gone for 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data.|||pmol/mg||Standard Deviation|Mean
2689034|NCT01329562|Primary|Biomarkers Measured at Menstrual Migraine Headache Onset, Migraine Headache Free, and 24 Hours Migraine Headache Free.|"VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected at Menstrual Migraine Headache Onset, Migraine Headache Free and 24 Hours Migraine Headache Free in Treximet vs. Placebo arm for 1 menstrual migraine headache.~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. CGRP and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes."|From baseline to 24 hours post headache gone for 1 menstrual migraine headache.|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data.|||pg/mL||Standard Deviation|Mean
2717842|NCT01116882|Secondary|Rate of Stent Thrombosis||12 months||||participants|||Number
2689035|NCT01329562|Secondary|α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders|"α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Responders vs Non-Responders*.~*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From Baseline until 2 hours post treatment of 1 menstrual migraine headache.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||U/L||Standard Deviation|Mean
2689036|NCT01329562|Secondary|CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders|"CGRP levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post-Treatment in Responders vs Non-Responders**.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure.~**A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||pmol/mg||Standard Deviation|Mean
2689037|NCT01329562|Secondary|Biomarkers Measured at Baseline, Menstrual Migraine Onset, and 2 Hours Post Treatment in Responders vs Non-Responders|"VIP, PGE2, Cortisol, PGI2, Estradiol, and β-endorphin** levels collected for 1 menstrual migraine headache at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms in responders vs. non-responders***.~*This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same unit of measure. CGRP and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes.~***A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From Baseline until 2 Hours post menstrual migraine treatment for 1 menstrual migraine headache.|Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||pg/mL||Standard Deviation|Mean
2689038|NCT01329562|Secondary|Time to Pain-Free in Responders vs Non-Responders|"Duration of time from treatment at menstrual migraine headache onset until pain-free in Treximet vs. Placebo arms in responders* vs. non-responders for 1 menstrual migraine.~0-3 Pain Scale, with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe.~*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From the onset of 1 menstrual migraine headache until pain-free.||||hours||Standard Deviation|Mean
2689039|NCT01329562|Secondary|Migraine Recurrence Responders vs Non-Responders|"Number of subjects either pain-free or mild at 2 hours then pain level increases within 24 hours following treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache with Treximet vs. Placebo in responders* vs. non-responders.~0-3 Pain Scale with 0=No Pain, 1=Mild, 2=Moderate, and 3=Severe~*A responder is defined as those who at the time of two hours post treatment reported mild or no pain. Additionally, these subjects could not have taken a rescue medication or have a pain level increase within 24 hours post treatment.~A non-responder is one that fails to meet the responder criteria."|From the onset of 1 menstrual migraine until 24 hours post treatment.||||participants|||Number
2689040|NCT01329562|Primary|α-Amylase Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment|"α-Amylase levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arm for 1 menstrual migraine headache~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure."|From Baseline until 2 hours post treatment for 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||U/L||Standard Deviation|Mean
2689041|NCT01329562|Primary|CGRP Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment|"CGRP levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache~* This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure."|From Baseline until 2 hours post treatment for 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||pmol/mg||Standard Deviation|Mean
2689042|NCT01329562|Primary|Biomarkers Measured at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment|"Vasoactive Intestinal Peptide (VIP), Prostaglandin E2 (PGE2), Cortisol, Prostaglandin I2 (PGI2), Estradiol, and β-endorphin** levels collected at Baseline, Menstrual Migraine Headache Onset, and 2 Hours Post Treatment in Treximet vs. Placebo arms for 1 menstrual migraine headache * This endpoint was separated into 3 outcome measures as all biomarkers were not reported in the same units of measure. Calcitonin Gene-Related Peptide (CGRP) and α-amylase both have their own outcome measure reported individually.~**β-endorphin levels were not assayed due to limitations on saliva sample volumes."|From Baseline until 2 hours post treatment of 1 menstrual migraine headache|In Group B, one subject's sample was unable to be analyzed by the laboratory, therefore Group B has one less subject in the placebo arm (N=10) for all biomarker data. Sample size for each arm may vary at each time point and/or biomarker based on laboratory results obtained due to sample collection errors.|||pg/mL||Standard Deviation|Mean
2689065|NCT01329263|Primary|Smoking Topography- Carbon Monoxide Boost|Carbon monoxide content in exhaled breath samples is measured before and after each cigarette smoked during study sessions. CO boost is the amount in parts per million that the subject's CO increases.|Measured before and after each cigarette smoked at study sessions||||parts per million||Standard Error|Mean
2689044|NCT01329562|Primary|Migraine Recurrence|"Number of subjects either pain free or mild at 2 hours then pain level increases within 24 hours following treatment with Treximet versus (vs.) Placebo for 1 menstrual migraine.~0-3 pain scale with 0=No Pain, 1=Mild, 2=Moderate,and 3=Severe."|From onset of a single menstrual migraine episode to 24 hours post menstrual migraine treatment.||||participants|||Number
2689045|NCT01329549|Secondary|Apparent Volume of Distribution at Steady State (Vss)|"Vss was evaluated for doxorubicin, free platinum, total platinum. Descriptive statistics were not calculated in the study report.~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set||||||
2689046|NCT01329549|Secondary|Total Plasma Clearance (CL)|"CL was evaluated for doxorubicin, free platinum, total platinum. Descriptive statistics were not calculated in the study report.~Detailed outcome measure time frame:~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set||||||
2689047|NCT01329549|Secondary|Terminal Half-life (t1/2)|"t1/2 was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.~Detailed outcome measure time frame:~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2~nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set||||||
2689048|NCT01329549|Secondary|Time From Dosing to the Maximum Plasma Concentration (Tmax)|"tmax was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW, BIBF 1202 glucuronide), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.~Detailed outcome measure time frame:~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2~nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set||||||
2689049|NCT01329549|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero Extrapolated to Infinity (AUC0-∞)|"AUC0-∞ was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.~Detailed outcome measure time frame~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2~nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set||||||
2689050|NCT01329549|Secondary|Area Under the Plasma Concentration-time Curve Over the Time Interval From Zero to the Time of the Last Quantifiable Drug Concentration (AUC0-tz)|"AUC0-tz was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW, BIBF 1202 glucuronide), PLD (doxorubicin), and carboplatin (free platinum, total platinum). Descriptive statistics were not calculated in the study report.~Detailed outcome measure time frame:~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2~nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set||||||
2689051|NCT01329549|Secondary|Maximum Measured Plasma Concentration (Cmax)|"Cmax was evaluated for nintedanib (BIBF 1120 BS, BIBF 1202 ZW, BIBF 1202 glucuronide), PLD (doxorubicin), and carboplatin (free platinum, total platinum). This endpoint has not been statistically analyzed in the study report.~Detailed outcome measure time frame:~total platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31, 46.917,166.917, 334.917, and 502.917 hours after start of infusion of carboplatin in Cycle 1 and 2~free platinum: pre-dose, 0.5, 1, 1.25, 1.75, 2.25, 3.5, 5.5, 7, 8.5, 22.917, 25, 27, 31 hours after start of infusion of carboplatin in Cycle 1 and 2~PLD: pre-dose, 0.5, 1, 1.5, 2, 2.25, 2.75, 3.25, 4.5, 6.5, 8, 9.5, 25, 27, 30, 34, 47.917, 167.917, 335.917, and 503.917 hours after start of infusion of PLD in Cycle 1 and 2~nintedanib and its metabolites: pre-dose, 1, 2, 3, 4, 6, 8, 10, 23.917 hours after first administration of nintedanib in Cycle 1 and 2"|0.5h after the start of the infusion up to 56 days|Treated set||||||
2689052|NCT01329549|Primary|Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) of Nintedanib|to determine the MTD of nintedanib in combination with carboplatin (AUC 5 mg/mL·min) and PLD (30 mg/m2) reflected by the number of DLTs per dose level. This endpoint has not been statistically analyzed in the study report.|28 days|Treated set||||||
2689053|NCT01329419|Secondary|Number of Participants With the Indicated Unexpected Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.|12 weeks|ITT Population|||participants|||Number
2689054|NCT01329419|Secondary|Number of Participants With a Serious Adverse Event|"A serious adverse event is any untoward medical occurrence that, at any dose: results in death /is life-threatening; requires hospitalization or prolongation of exixting hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is another medically significant event. For a list of all serious adverse events occurring during the course of the study, please see the table entitled Serious Adverse Events in the Adverse Event section of the results record."|12 weeks|ITT Population|||participants|||Number
2689055|NCT01329419|Primary|Number of Participants With an Adverse Event|"An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled Other (non-serious) adverse events in the Adverse Event section of the results record."|12 weeks|Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments|||participants|||Number
2689056|NCT01329380|Secondary|Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale [NRS]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 where lower scores indicate less disease activity.|Baseline and weeks 12 and 24|Efficacy analysis population with available BASDAI data at baseline and each timepoint|||units on a scale||Standard Deviation|Mean
2689057|NCT01329380|Secondary|Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors|"Participants were evaluated for improvement at weeks 12 and 24 of treatment or discontinuation of treatment or participation in the survey based on the clinical course from baseline using the following scale:~1. Markedly improved, 2. Improved, 3.Not improved, 5. Not assessable"|24 weeks (or last visit if earlier)|Efficacy analysis set; results are only included for participants with non-missing data for each baseline characteristic.|||Participants|||Count of Participants
2689058|NCT01329380|Secondary|Number of Participants With Markedly Improved or Improved Rating|"Participants were evaluated for improvement at weeks 12 and 24 of treatment or discontinuation of treatment or participation in the survey based on the clinical course from baseline using the following scale:~1. Markedly improved, 2. Improved, 3.Not improved, 5. Not assessable"|Weeks 12, 24, and at the last visit|Efficacy analysis population; participants with available data at each timepoint|||Participants|||Count of Participants
2689059|NCT01329380|Primary|Number of Participants With Self-injection Errors||24 weeks|Participants in the safety analysis set who self-injected adalimumab|||Participants|||Count of Participants
2689060|NCT01329380|Primary|Number of Participants With Adverse Events|"An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.~A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage."|24 weeks|Safety analysis set|||Participants|||Count of Participants
2689061|NCT01329380|Primary|Number of Participants With Adverse Drug Reactions by Baseline Factors|"An adverse drug reaction (ADR) is an injury caused by taking a medication, in which a causative relationship can be shown. ADRs are reported by baseline characteristics.~NSAID: non-steroidal anti-inflammatory drug~DMARD: disease-modifying anti-rheumatic drug~BASDAI: Bath Ankylosing Spondylitis Disease Activity Index"|24 weeks|Safety analysis set; results are only included for participants with non-missing baseline data for each characteristic.|||Participants|||Count of Participants
2689062|NCT01329380|Primary|Number of Participants With Adverse Drug Reactions|"An adverse drug reaction (ADR) is an injury caused by taking a medication, in which a causative relationship can be shown.~A serious adverse drug reaction is any untoward medical occurrence that at any dose;~Results in death~Life threatening~Requires inpatient hospitalization or prolongation of existing hospitalization~Results in persistent of significant disability or incapacity"|24 weeks|Safety analysis set|||Participants|||Count of Participants
2689063|NCT01329263|Primary|Subjective Rating of Cigarettes|Subjects completed a visual analog scale rating each cigarette smoked at each session. Subjects rated characteristics of the cigarette on a scale represented as a continuous horizontal line 10 cm long. Subjects drew an intersecting line to represent their rating. The rating reported is for the taste of the cigarette at the end of the period averaged across subjects in the group. A rating of 0 corresponds to Very Bad and a rating of 100 to Very Good for taste. There is no better or worse outcome for higher or lower ratings for taste.|Immediately after a cigarette smoked at the study session|Completed measure|||units on a scale||Standard Error|Mean
2689064|NCT01329263|Primary|Nicotine Levels|Urine nicotine levels will be measured to examine the effect of cigarette menthol on harm exposure measures. Participants provided samples on the final day of each period. NNK and 1-hop were not analyzed, total nicotine metabolites were assayed.|35 days|Those completing Day 5, returning sample for assay|||micrograms/mL||Standard Error|Mean
2689137|NCT01328756|Primary|Change From Baseline in Height at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||centimeter(s)||Standard Deviation|Mean
2689066|NCT01329263|Primary|Smoking Topography- Puff Volume|The total puff volume for a single subject is the sum of puff volumes for a subject's cigarette smoked during the study session. The mean puff volume for the subjects will be used to examine the effect of cigarette menthol on smoking topography. The values provided are the average of subjects at study Day 5 (completion of baseline smoking own cigarettes), Day 20 and Day 35.|over 35 day study period|Those completing Study session 2 at Day 5.|||mL||Standard Error|Mean
2689067|NCT01329198|Secondary|Correlation of Tics and Neural Physiology|Electrical recordings of electroencephalography activity were taken from each subject's implanted leads at each visit from baseline to 6 months. At baseline, the recordings were taken with the device in the off state (not stimulating), while at the 6 month visits the recordings were taken with the subject's device set to optimal parameters for tic control. Using Pearson's correlation coefficient, the variations in frequency and power which were observed were correlated with the Yale Global Tic Severity (YGTSS) scores obtained during primary outcome testing.|Baseline to 6 Months||||Pearson Correlation Coefficient|||Number
2689068|NCT01329198|Primary|Mean Change in Yale Global Tic Severity Scale (YGTSS) Scores From Baseline to 6 Months Across All Study Participants Presented|"The Yale Global Tic Severity Scale (YGTSS) is a semistructured clinician-rated instrument that assesses the severity and frequency of motor and phonic tics over the previous week. Five index scores are obtained during the assessment, where higher scores indicate greater frequency or severity. These indices are:~Total Motor Tic Score (0-25)~Total Phonic Tic Score (0-25~Total Tic Score (0-50)~Overall Impairment Rating (0-50)~Global Severity Score (0-7)~The YGTSS Total Score is obtained by adding the Total Tic Score to the Overall Impairment Rating. The efficacy of the intervention will be assessed by comparing each subject's 6-month YGTSS Total Score to the pre-operative value for the same patient. Efficacy is considered 50% or greater reduction in this score."|Baseline to 6 Months||||units on a scale||95% Confidence Interval|Mean
2689069|NCT01329185|Primary|Incidence of EBV or CMV Related Disease in Transplant Recipient|Incidence of EBV or CMV related disease in the transplant recipients of enrolled donors.|At least 1 year||||participants|||Number
2689070|NCT01329029|Secondary|Change From Baseline in Body Mass Index (BMI)|Body mass index (BMI) is a measure of body fat based on height and weight. Least Square Means was from an ANCOVA model including LOCF.|Baseline and Week 52|Participants from the Safety Population, all randomized participants who received at least one dose of study drug, with data available for analysis.|||kg/m^2||Standard Error|Least Squares Mean
2689071|NCT01329029|Secondary|Change From Baseline in Body Weight|Least Square Means was from an ANCOVA model including Last Observation Carried Forward (LOCF).|Baseline and Week 52|Participants from the Safety Population, all randomized participants who received at least one dose of study drug, with data available for analysis.|||kilogram (kg)||Standard Error|Least Squares Mean
2689072|NCT01329029|Secondary|Percentage of Participants Who Experienced at Least 1 Treatment Emergent Adverse Event (TEAE)|An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.|52 Weeks|Safety Population included all randomized participants who received at least one dose of study drug.|||percentage of participants|||Number
2689073|NCT01329029|Secondary|Time to Trial Withdrawal Due to an Adverse Event|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with events.|||days||Full Range|Median
2689074|NCT01329029|Secondary|Time to First Hospitalisation Due to Any Cause During the Treatment Period|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with events.|||days||95% Confidence Interval|Median
2689075|NCT01329029|Secondary|Percentage of Participant With All-Cause Hospitalisation During the Treatment Period|Percentage of patients with at least one hospital admission due to any cause.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||percentage of participants|||Number
2689076|NCT01329029|Secondary|Time to First Major Adverse Cardiovascular Event (MACE) During the Treatment Period|Composite MACE is a combined endpoint(cardiovascular death [including death due to undetermined cause], nonfatal myocardial infarction, and nonfatal stroke). Time to event was calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.|||days||Full Range|Median
2689077|NCT01329029|Secondary|Percentage of Participants With Major Adverse Cardiovascular Event (MACE) During the Treatment Period|Composite MACE is a combined endpoint (cardiovascular death [including death due to undetermined cause], nonfatal myocardial infarction, and nonfatal stroke).|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||percentage of participants|||Number
2689078|NCT01329029|Secondary|Time to Withdrawal Due to COPD Exacerbation During the Treatment Period|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.|||days||Full Range|Median
2700353|NCT01243320|Primary|Change In Aspartate Aminotransferase Blood Level|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||u/L||95% Confidence Interval|Mean
2689079|NCT01329029|Secondary|Time to Withdrawal During the Treatment Period|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.|||days||Full Range|Median
2689080|NCT01329029|Secondary|Time to Mortality Due to COPD Exacerbation During the Treatment Period|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.|||days||Full Range|Median
2689081|NCT01329029|Secondary|Time to Mortality Due to Any Reason During the Treatment Period Score|Time to event will be calculated as date of onset of event — date of first intake of double-blind study drug + 1 day.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.|||days||Full Range|Median
2689082|NCT01329029|Secondary|Percentage of Participants With Improvement in CAT|Participants completed the CAT questionnaire at Baseline and after 52 Weeks of treatment. The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. Improvement was defined as a CAT Total Score reduction from Baseline > 1.6.|Baseline and Week 52|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||percentage of participants|||Number
2689083|NCT01329029|Secondary|Change From Baseline in COPD Assessment Test (CAT) Total Score|Participants completed the CAT questionnaire at Baseline and after 52 Weeks of Treatment. The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. A negative change from Baseline indicates improvement. Least-squares means from ANCOVA including treatment by time interaction.|Baseline and Week 52|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||score on a scale||Standard Error|Mean
2689084|NCT01329029|Secondary|Percentage of Rescue Medication-Free Days|Participants recorded their use of rescue medication in a daily diary. The percentage of days without rescue medication use.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||percentage of days||Standard Deviation|Mean
2689085|NCT01329029|Secondary|Percentage of Symptom-Free Days|Symptoms of COPD (cough, sputum) were recorded in a daily diary. The percentage of days without symptoms is reported.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||percentage of days||Standard Deviation|Mean
2689086|NCT01329029|Secondary|Change From Baseline in COPD Symptom Score From Daily Diary|Participants recorded COPD symptoms cough and sputum production in a daily diary. Cough was assessed using a 4-point scale where 0=No cough to 3=severe cough and sputum was assessed using a 4-point scale where 0=no sputum production to 3=severe sputum production. Least-squares means from ANCOVA including treatment by time interaction. A negative change from Baseline indicates improvement. Total symptom score is the sum of cough and sputum scores, ranging from 0 (best possible outcome) to 6 (worst possible outcome).|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||score on a scale||Standard Error|Least Squares Mean
2689087|NCT01329029|Secondary|Change From Baseline in Use of Rescue Medication From Daily Diary|Salbutamol metered dose inhaler was available as rescue medication during the study. The participant recorded the use of rescue medication in a daily diary. A negative change from Baseline indicates an improvement.|Baseline and Week 52|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data included in the repeated measurements analysis.|||puffs per day||Standard Error|Least Squares Mean
2689088|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator FEV1/FVC|The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation. Pulmonary function testing was performed using centralized spirometry. A positive change from Baseline indicates improvement.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||percent||Standard Deviation|Mean
2689089|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First 6 Seconds (FEV6)|FEV6 is the amount of air which can be forcibly exhaled from the lungs in the first six seconds of a forced exhalation. Pulmonary function testing was performed using centralized spirometry. A positive change from Baseline indicates improvement.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||liters||Standard Error|Least Squares Mean
2689090|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator Forced Expiratory Flow at 25% to 75% of Vital Capacity (FEF25-75%)|Forced expiratory flow 25-75% (FEF25-75%) is the flow (or speed) of air coming out of the lung during the middle half of a forced expiration. Pulmonary function testing was performed using centralized spirometry. Least-squares means was from ANCOVA including treatment by time interaction. A positive change from Baseline indicates improvement.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||liters/second||Standard Error|Least Squares Mean
2717843|NCT01116882|Secondary|Ischemia-driven Target Lesion Revascularization||12 months||||participants|||Number
2689091|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator Forced Vital Capacity (FVC)|Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Least-squares means was from ANCOVA including treatment by time interaction. A positive change from Baseline indicates improvement.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||liters||Standard Error|Least Squares Mean
2689092|NCT01329029|Secondary|Duration of Moderate or Severe COPD Exacerbations Per Participant|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis. n in each of the categories is the number of participants with exacerbations.|||days||Standard Deviation|Mean
2689093|NCT01329029|Secondary|Number of Moderate or Severe COPD Exacerbation Days|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. The number of exacerbation days per patient is the sum of durations (stop date of exacerbation — start date of exacerbation + 1) of all exacerbations within the category.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||days||Standard Deviation|Mean
2689094|NCT01329029|Secondary|Number of Patients Needed to Treat to Avoid 1 Moderate or Severe COPD Exacerbation Derived From Exacerbation Per Patient Per Year|The number needed to treat (NNT) analysis is a simple, concise method to quantify directly the benefits that alternative treatment options have on disease outcomes in terms of the number of patients who need to be treated before a benefit is observed. Risk reduction: Rate(Placebo)— Rate (Roflumilast 500 μg), Number needed to treat for benefit (NNTB): 1/(Risk reduction). A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||participants|||Number
2689095|NCT01329029|Secondary|Time to Third Moderate or Severe COPD Exacerbation|Time to event was calculated as date of onset of event — date of first intake of double-blind study drug + 1 day for events: moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.|||days||Full Range|Median
2689096|NCT01329029|Secondary|Time to Second Moderate or Severe COPD Exacerbation|Time to event was calculated as date of onset of event — date of first intake of double-blind study drug + 1 day for events: moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as Severe: Requiring hospitalization and/or leading to death; Moderate: Requiring oral or parenteral glucocorticosteroid therapy.|52 Weeks (some participants extended treatment beyond 52 Weeks and are included in the analysis)|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.|||days||95% Confidence Interval|Median
2689097|NCT01329029|Secondary|Time to First COPD Exacerbation All Categories|Time to event was calculated as date of onset of event — date of first intake of double-blind study drug + 1 day for all events: mild, moderate or severe. A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management.|52 Weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized.|||days||95% Confidence Interval|Median
2689098|NCT01329029|Secondary|Percentage of Participants Experiencing at Least 1 COPD Exacerbation|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||percentage of participants|||Number
2689099|NCT01329029|Secondary|Rate of COPD Exacerbations Per Patient Per Year All Categories|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as follows: Severe=Requiring hospitalization and/or leading to death; Moderate=Requiring oral or parenteral glucocorticosteroid therapy. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||exacerbations per patient per year||95% Confidence Interval|Mean
2689138|NCT01328756|Primary|Change From Baseline in Body Weight at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||kilogram(s)||Standard Deviation|Mean
2717844|NCT01116882|Secondary|Ischemia-driven Target Lesion Revascularization||30 days||||participants|||Number
2689100|NCT01329029|Secondary|Rate of Severe COPD Exacerbations Per Patient Per Year|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. Severe COPD exacerbations were categorized as requiring hospitalization and/or leading to death. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||exacerbations per patient per year||95% Confidence Interval|Mean
2689101|NCT01329029|Secondary|Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in the First Second (FEV1)|Pulmonary function testing was performed using centralised spirometry. FEV1 is the maximum amount of air that can be forcefully exhaled in one second. Least-squares means is from Analysis of Covariance (ANCOVA) including treatment by time interaction. A positive change from Baseline indicates improvement.|Baseline and Week 52|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||liters||Standard Error|Least Squares Mean
2689102|NCT01329029|Primary|Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year|A COPD exacerbation is an event in the natural course of the disease characterized by a worsening in the patient's baseline dyspnoea, cough, and/or sputum production beyond day to day variability sufficient to warrant a change in management. COPD exacerbations were categorized as follows: Severe=Requiring hospitalization and/or leading to death; Moderate=Requiring oral or parenteral glucocorticosteroid therapy. The defined number of days a patient was in the trial was divided by 365.25, in order to express the duration as a fraction of 1 year.|52 weeks|Participants from the Intent-to treat population, all randomized participants who received at least 1 dose of study drug analyzed by the treatment for which they were randomized, with data available for analysis.|||exacerbations per patient per year||95% Confidence Interval|Mean
2689103|NCT01328964|Secondary|Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period|The mean total asthma costs are a sum of pharmacy and medical costs. Costs were determined monthly from the pharmacy and medical encounters recorded in the managed care insurance database. All costs were summed for each participant over the 3-12 month follow-up period (post-index period), and a mean monthly cost was calculated by dividing by the follow-up for each participant.|12 months prior to January 1, 2000 to June 30, 2008|Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.|||United States dollars||Standard Deviation|Mean
2689104|NCT01328964|Secondary|Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years|The number of participants with an asthma-related event was computed during the follow-up period and was standardized by dividing by the total days of follow-up in each cohort since participants had different lengths of follow-up. Per 100 person years is equal to the percent of events that occurred during the observed time period of the study.|12 months prior to January 1, 2000 to June 30, 2008|Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.|||Asthma related events per100 person year|||Number
2689105|NCT01328964|Secondary|Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period|The mean total asthma costs are a sum of pharmacy and medical costs. Costs were determined monthly from the pharmacy and medical encounters recorded in the managed care insurance database. All costs were summed for each participant over the 3-12 month follow-up period (post-index period), and a mean monthly cost was calculated by dividing by the follow-up for each participant.|12 months prior to January 1, 2000 to June 30, 2008|Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.|||United States dollars||Standard Deviation|Mean
2689106|NCT01328964|Primary|Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years|The number of participants with an asthma-related event was computed during the follow-up period and was standardized by dividing by the total days of follow-up in each cohort since participants had different lengths of follow-up. Per 100 person years is equal to the percent of events that occurred during the observed time period of the study.|January 1, 2000 to June 30, 2008|Members of the IMS Life Link Health Plans Claims Database (containing data from >=90 managed healthcare plans, encompassing >=60 million lives) who had >=1 pharmacy claim during the study period. FSC participants were matched 1:2 to budesonide and montelukast separately, leading to different numbers analyzed for FSC dependent on cohort of interest.|||asthma events per 100 person years|||Number
2689107|NCT01328951|Secondary|Percentage of Participants With CR, PR, or SD According to RECIST During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. SD was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. The percentage of participants with a best overall response of CR, PR, or SD (i.e., the disease control rate [DCR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2689139|NCT01328756|Primary|Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||mmHg||Standard Deviation|Mean
2689108|NCT01328951|Secondary|Percentage of Participants by Best Overall Response According to RECIST During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to <10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. Stable disease (SD) was defined as neither sufficient shrinkage in target lesions to qualify for PR nor sufficient growth to qualify for disease progression. Disease progression (progressive disease/PD) was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants with each level of best tumor response during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2689109|NCT01328951|Secondary|Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to RECIST During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and short-axis reduction to less than (<) 10 mm of any pathological lymph nodes. PR was defined as a ≥30% decrease in the sum of target lesion diameters in reference to the Baseline sum. The percentage of participants with a best overall response of either CR or PR (i.e., the objective response rate [ORR]) during the BP was calculated, and corresponding 95% CI was constructed using the Pearson-Clopper method.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2689110|NCT01328951|Secondary|Percentage of Participants Event-Free (Alive and No Disease Progression) at 6 Months During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants event-free (i.e., still alive and without disease progression) at 6 months during the BP was calculated.|At 6 months|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2689111|NCT01328951|Secondary|Progression-Free Survival (PFS) as Median Time to Event During Blinded Treatment|Tumor response was evaluated using RECIST version 1.1. Disease progression was defined as a ≥20% and ≥5-mm increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. PFS was defined as the interval between date of randomization and date of first documented death or disease progression. Median time to event during the BP was estimated using the Kaplan-Meier method and expressed in weeks.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.|||weeks||95% Confidence Interval|Median
2689112|NCT01328951|Secondary|Percentage of Participants Who Died or Experienced Disease Progression During Blinded Treatment|Tumor response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and ≥5-millimeter (mm) increase in the sum of target lesion diameters in reference to the smallest sum on study and/or substantial worsening in non-target disease. The percentage of participants who died or experienced disease progression during the BP was calculated.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP)|ITT Population.|||percentage of participants|||Number
2689113|NCT01328951|Primary|Percentage of Participants Event-Free (Alive) at 1 Year During the Overall Study|Participants were followed for survival until death or premature withdrawal. The percentage of participants event-free (i.e., still alive) at 1 year during the Overall Study was calculated.|At 1 year|ITT Population.|||percentage of participants||95% Confidence Interval|Number
2689114|NCT01328951|Primary|Overall Survival (OS) as Median Time to Event During the Overall Study|Participants were followed for survival until death or premature withdrawal. OS was defined as the interval between date of randomization and date of death from any cause. Median time to event during the Overall Study (BP, OLP, or SFU) was estimated using the Kaplan-Meier method and expressed in months.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death)|ITT Population.|||months||95% Confidence Interval|Median
2689115|NCT01328951|Primary|Percentage of Participants Who Died During the Overall Study|Participants were followed for survival until death or premature withdrawal. The percentage of participants who died during the Overall Study (BP, OLP, or SFU) was calculated.|Up to approximately 3.5 years (visits at Baseline and Weeks 6, 12, and 18 and every 12 weeks until/at disease progression during BP; per local standards during OLP; then every 12 weeks during SFU until death)|ITT Population.|||percentage of participants|||Number
2689116|NCT01328873|Secondary|Number of Participants With Positive Myocbacteria Results by Culture|To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates|24-48 hours||||participants|||Number
2689117|NCT01328873|Secondary|Number of Participants With Positive Viral Results by PCR|To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates|24-48 hours||||participants|||Number
2689118|NCT01328873|Secondary|Number of Patients With Positive Fungal Results by PCR|To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates|24-48 hours||||participants|||Number
2689119|NCT01328873|Secondary|Number of Participants With Positive Bacterial Results by PCR|To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates|24-48 hours||||participants|||Number
2689120|NCT01328873|Secondary|Number of Patients With Positive CT Result|"To correlate specific types of pulmonary infiltrates (focal, multifocal, or diffuse interstitial or alveolar infiltrates) with microbiological findings. Patients were evaluated by changes on the CT and categorized as follows:~Air space~ground glass/reticular nodular~nodular/cavitary~single patchy infiltrate"|30 days||||participants|||Number
2689140|NCT01328756|Primary|Change From Baseline in Sitting Diastolic Blood Pressure (DBP) at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||mmHg||Standard Deviation|Mean
2689121|NCT01328873|Primary|Number of Patients With Positive Culture or Molecular Results After Brochoscopy|To determine the diagnostic yield related to fiberoptic bronchoscopy (FOB) with bronchoalveolar lavage (BAL) in hematopoietic stem cell transplant (HSCT) and leukemia patients with acute respiratory symptoms and pulmonary infiltrates utilizing both current standard of care microbiology testing and emerging molecular genetic laboratory assessments.|30 days||||participants|||Number
2689122|NCT01328782|Secondary|Need for IV Morphine of Fentanyl|Indicates that number of subjects that were in severe pain and thus required IV morphine and/or fentanyl.|First 120 minutes after the end of surgery (surgery close time)|All subjects were included in the analysis.|||participants|||Number
2689123|NCT01328782|Secondary|Total Dosage in Morphine Equivalents (mg/kg) of All Analgesics Received in Prior to Discharge||Analgesic data collected during first four hours following the end of surgery (surgery close)|All subjects were included in the analysis.|||Morphine (po) equivalents [mg*kg-1]||Standard Deviation|Mean
2689124|NCT01328782|Secondary|Time (in Minutes) to First Narcotic Administration||first 72 hours after surgery close time|All subjects were included in the analysis.|||Minutes||Inter-Quartile Range|Median
2689125|NCT01328782|Secondary|Total Quality Pain Management Survey (TQPM) Scores for Questions # 16: Child's Current Level of Pain, Question # 17: Child's Worst Level of Pain When Moving Around After Surgery and Question # 18: Child's Worst Level of Pain While Resting|Total quality pain management survey is validated survey used to assess parents' perceptions of their child's pain. Pain is assessed on a dimensionless 10 pt likert scale from 0 (no pain) to 10 (severe pain). Greater pain scores are indicative or more severe pain.|Will be obtained from parent(s) 120 minutes after arrival to the recovery room|Based on number of participants and their parents/legal guardians that completed the survey.|||Scores on a scale||Standard Deviation|Mean
2689126|NCT01328782|Primary|The Faces Pain Scale-Revised (FSP-R) Scores (Scored 0-10).|The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.|Will be obtained 30 - 60 minutes after arrival to the recovery room|Based on the number of participants that self-reported their pain score.|||Scores on a scale||Standard Deviation|Mean
2689127|NCT01328769|Secondary|Change in Endothelial Function|Endothelial function was calculated by software from the manufacturer VENDYS. The measurement was taken by using the index of area under the curve of the finger temperature recovery curve just after releasing a blood pressure cuff. The blood pressure cuff occluded blood flow for 5 minutes as compared to the temperature curve in the non-occluded arm.|Baseline to 6 weeks||||ratio of finger temperature||Standard Deviation|Mean
2689128|NCT01328769|Primary|Change in Renal Plasma Flow in Response to Infused Angiotensin II||Baseline to 6 weeks||||ml/minute||Standard Error|Mean
2689129|NCT01328756|Secondary|Number of Participants With Clinical Global Impression-Severity of Illness (CGI-S) at Last On-treatment Assessment (LOTA)|The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-S was a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants), evaluated by the Investigator.|LOTA (Week 104)|FAS population|||participants|||Number
2689130|NCT01328756|Secondary|Number of Participants With Clinical Global Impression-Global Improvement (CGI-I) at Last On-treatment Assessment (LOTA)|The Clinical Global Impressions (CGI) Scale permits a global evaluation of the participants' severity and improvement over time. This assessment will help guide the clinician on dosing adjustments. The CGI has been used extensively in clinical studies of ADHD. CGI-I was a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), evaluated by the Investigator.|LOTA (Week 104)|FAS population|||participants|||Number
2689131|NCT01328756|Secondary|Change From Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Total Score at Last On-treatment Assessment (LOTA)|ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria, completed by the Investigator. Each item was scored from a range of 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54. The 18 items were grouped into 2 sub-scales: hyperactivity/impulsivity (even number items 2-18 with score range of 0 to 27) and inattention (odd number items 1-17 with score range of 0 to 27). Higher scores depicted worse symptoms.|Baseline (Week 0), LOTA (Week 104)|Full Analysis Set (FAS) population included all participants who took at least 1 dose of SPD489 and had at least 1 on-treatment post baseline efficacy assessment.|||Scores on a scale||Standard Deviation|Mean
2689132|NCT01328756|Primary|Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRSC) Total Scores at Last On-treatment Assessment (LOTA)|The BPRS-C that was designed to provide a characterization of the child and adolescent psychopathology, was used to monitor participant's safety. The BPRS-C assessed 7 independent factors (3 items each), for a total of 21 items that represented behavioural disorders, depression, thinking disturbance, psychomotor excitation, withdrawal retardation, anxiety, and organicity. Each item was rated using a 7-point scale including 0 (not present), 1 (very mild), 2 (mild), 3 (moderate), 4 (moderately severe), 5 (severe), and 6 (extremely severe). Total score is the sum of each item score; range from 0 to 126. Higher score indicated worse psychology.|Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||scores on a scale||Standard Deviation|Mean
2689133|NCT01328756|Primary|Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||milliseconds||Standard Deviation|Mean
2689134|NCT01328756|Primary|Change From Baseline in QT Interval at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||milliseconds||Standard Deviation|Mean
2689135|NCT01328756|Primary|Change From Baseline in Heart Rate at Last On-treatment Assessment (LOTA)||Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||beats per minute||Standard Deviation|Mean
2689136|NCT01328756|Primary|Change From Baseline in Body Mass Index (BMI) at Last On-treatment Assessment (LOTA)|BMI was calculated as (weight [kilogram] per height [square meter]).|Baseline (Week 0), LOTA (Week 104)|Safety population with participants evaluable for this outcome|||kilogram per square meter||Standard Deviation|Mean
2689142|NCT01328756|Primary|Number of Participants With All Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs|An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. It included both serious and non-serious adverse event. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were defined as treatment-emergent if they started or worsened during the period between the day of a participant's first dose of investigational product in this study and the 3 days following cessation of treatment.|Baseline up to 3 days after the last dose of study treatment (up to 2 years)|Safety population included all participants who took at least 1 dose of Lisdexamfetamine dimesylate during this study.|||participants|||Number
2689143|NCT01328743|Primary|Number of Alcoholic Drinks Consumed|Number of standard alcoholic drinks consumed per week in the past month|6 months||||drinks per week||Inter-Quartile Range|Median
2689144|NCT01328743|Primary|Number of Alcoholic Drinks Consumed|Number of standard alcoholic drinks consumed per week in the past month|3 months||||drinks per week||Inter-Quartile Range|Median
2689145|NCT01328743|Primary|Number of Heavy Drinking Days|Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month|3 months||||Days||Inter-Quartile Range|Median
2689146|NCT01328743|Primary|Number of Heavy Drinking Days|Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month|6 months||||Days||Inter-Quartile Range|Median
2689147|NCT01328743|Primary|Number of Heavy Drinking Days|Number of heavy drinking days (drinking 5 or more drinks in a day) in the past month|12 months||||Days||Inter-Quartile Range|Median
2689148|NCT01328743|Primary|Number of Alcoholic Drinks Consumed|Number of standard alcoholic drinks consumed per week in the past month|12 months||||drinks per week||Inter-Quartile Range|Median
2689149|NCT01328717|Secondary|Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation)|Subjects read User Guide(UG)to learn to use the system and performed meter tasks. Study staff observed, then rated subjects' success (1 to 4) at performing tasks. Scale: 1.Performed tasks correctly without assistance. 2.Performed tasks correctly, but was directed to a specific part of the UG by the study staff as in a Customer Service call. 3.Performed tasks correctly, but required additional review/assistance similar to review of a specific function during a Customer Service call. 4.Subject incorrectly performed part of the testing regimen and was unaware of the error.|1 hour|Per protocol|||Number of Participants|||Number
2689150|NCT01328717|Primary|Percent of Fingerstick Blood Glucose (BG) Results Within +/-20%(>=75 mg/dL) and Within +/- 15mg/dL (<75 mg/dL) of Laboratory Glucose Method|Subjects with diabetes and study staff tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 20% (for reference BG results >=75mg/dL) and within +/- 15mg/dL(for reference BG results <75mg/dL) of the reference method results.|1 hour|As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, one subject did not complete the study. The remaining 77 subjects tested 2 test strip lots on the system. 2x77(154) test results were available.|||Percentage of BG test results|Participants||Number
2689151|NCT01328587|Primary|Proportion of Drug Responders|The portion of drug responders as defined by changes in the platelet count and/or platelet transfusion requirements or hemoglobin and/or PRBC transfusion requirements and the toxicity profile as measured using the CTCAE criteria. Treatment response for the platelet lineage is defined as an absolute increase of ≥20x10^9/L above baseline at 16 or 20 weeks, measured on at least two serial measurements performed one week apart and sustained for 1 month or more without support of platelet transfusions, or for transfusion dependent patients stable platelet counts with transfusion independence for ≥ 8 weeks. For patients with anemia (untransfused hemoglobin ≤ 8.5 g/dL), a treatment response will be an increase in Hb by ≥1.5g/dL at four months, measured on at least 2 serial measurements and sustained for 1 month or more without transfusion support OR for transfusion dependent patients, reduction of units of RCC transfused by 50%/8 weeks compared with the pretreatment transfusion number in th|16-20 weeks from start of drug||||Participants|||Count of Participants
2689152|NCT01328574|Secondary|Incidence of TRC-105-Related Adverse Events|Adverse events by grade, (e.g. 1 is mild, 2 is moderate, 3 is severe and 4 is life threatening) related to TRC-105.|24 months||||participants|||Number
2689153|NCT01328574|Secondary|Median Overall Survival|Date of on-study to the date of death from any cause or last follow up.|up to 25 months||||Months||95% Confidence Interval|Median
2689154|NCT01328574|Secondary|Objective Response|Objective response is defined as the number of participants who meet the criteria for a complete response (CR) or a partial response (PR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.|up to 25 months||||participants|||Number
2689155|NCT01328574|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|24 months||||participants|||Number
2689156|NCT01328574|Primary|Progression Free Survival|Time interval from start of treatment to documented evidence of disease progression. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progression).-|after 6 months on study||||Months||95% Confidence Interval|Median
2689157|NCT01328548|Other Pre-specified|Assessment of Immune Parameters Compatible With Inflammaging: CD4 Cell Frequency|Characterization of T-cell populations will be conducted on whole blood using multi-parametric flow cytometry prior to immunization to characterize the immunological function of circulating T-cells in the nursing home vaccine group.|Baseline|Predictor variables were assessed only among the frail elderly, the community control group served as a control for immunogenicity only.|||% of peripheral blood mononuclear cell||Standard Deviation|Mean
2689158|NCT01328548|Other Pre-specified|Testing 150 Candidate Immune Response Genes for SNP Analysis|These will include Tolllike receptors, cytokines, chemokines, chemokine receptors, interferons and interferon receptors. Tolllike receptors: TLR1TLR9 Cytokines: ILI1A, ILI1B, IL1RN, IL4, IL5, IL12B, IL13, CSF2 Chemokines: CCL1CCL3, CCL3L1, CCL4CCL8, CCL11, CCL13, CCL15CCL28, CXCL1CXCL14, CXCL16, CX3CL1 Chemokine receptors: CCR1CCR10, CXCR1CXCR6, CX3CR1, XCR1XCR2 Interferons: IFNA1IFNA2, IFNA4IFNA8, IFNA10, IFNA13, IFNA14, IFNA16IFNA17, IFNA21, IFNB1, IFNB3, IFNG, IFNK, IFNW1 Interferon receptors: IFNAR1, IFNAR2, IFNGR1, IFNGR2|Baseline|Genotyping was not conducted because of insufficient resources.||||||
2689159|NCT01328548|Other Pre-specified|Assessment of Immune Parameters Compatible With Inflammaging: High CD8+CD28CD45RA+T Cells|Characterization of Tcell populations will be conducted on whole blood using multiparametric flow cytometry prior to immunization to characterize the immunological function of circulating Tcells in each participant.|Baseline|Data not collected.||||||
2689160|NCT01328548|Other Pre-specified|Assessment of Immune Parameters Compatible With Inflammaging: TEMRA Cells|Characterization of Tcell populations will be conducted on whole blood using multiparametric flow cytometry prior to immunization to characterize the immunological function of circulating Tcells in each participant.|Baseline|Data not collected.||||||
2689161|NCT01328548|Primary|Assessment of Immune Parameters Compatible With Inflammaging: High T Regulatory Cells|Characterization of T-cell populations will be conducted on whole blood using multi-parametric flow cytometry prior to immunization to characterize the immunological function of circulating T-cells in the nursing home vaccine group.|Baseline|Predictor variables were assessed only among the frail elderly, the community control group served as a control for immunogenicity only.|||% of peripheral blood mononuclear cell||Standard Deviation|Mean
2689162|NCT01328548|Primary|Assessment of Immune Parameters Compatible With Inflammaging: CD4+/CD8+ Ratio|Characterization of T-cell populations will be conducted on whole blood using multi-parametric flow cytometry prior to immunization to characterize the immunological function of circulating T-cells in the nursing home vaccine group.|Baseline|Predictor variables were assessed only among the frail elderly, the community control group served as a control for immunogenicity only.|||T-cell ratio||Standard Deviation|Mean
2689163|NCT01328548|Primary|Change From Baseline in T-cell Response to the VZV Vaccine in the Frail Elderly|As the primary phenotype, we will compare change in Enzyme-linked immunosorbent spot (ELISPOT) from baseline (i.e., pre and post vaccination). A high baseline T cell response will be defined as ELISPOT = >50 spots and a low baseline response will be ELISPOT = <10 spots.|6 weeks|IFN-gamma T cell ELISpot assay (sfu) against VZV taken prior to vaccination and 6 weeks post vaccination|||Spot Forming Units per 10^6 PBMC||Standard Deviation|Mean
2689164|NCT01328535|Other Pre-specified|To Evaluate the Parameters of Immune Homeostasis That Are Associated With the Anti-tumor Immune Biorhythm in Order to Gain Insight Into the Mechanism of the Observed Clinical and Immunological Effect of Timed TMZ Chemotherapy||2 years|||||||
2689165|NCT01328535|Other Pre-specified|To Evaluate the Impact of Timed TMZ Chemotherapy on Immune Biomarkers and the Anti-tumor Immune Biorhythms.||6 months|||||||
2689166|NCT01328535|Secondary|Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)|"The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below."|Up to 2 years||||percentage of patients|||Number
2689167|NCT01328535|Secondary|Overall Survival|Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Up to 2 years||||months||95% Confidence Interval|Median
2689168|NCT01328535|Secondary|Progression-Free Survival|Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined as:At least one of the following must be true: At least one new malignant lesion, which also includes any lymph node that was normal at baseline (< 1.0 cm short axis) and increased to ≥ 1.0 cm short axis during follow-up. At least a 20% increase in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the MSD (Section 11.41). In addition, the PBSD must also demonstrate an absolute increase of at least 0.5 cm from the MSD. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.|Up to 2 years||||months||95% Confidence Interval|Median
2689169|NCT01328535|Primary|Progression-Free Survival at 4 Months|The distribution of time to progression will be estimated using the method of Kaplan-Meier and the 4 month progression-free rate (percentage) will be provided. Progression is defined as: At least one of the following must be true: At least one new malignant lesion, which also includes any lymph node that was normal at baseline (< 1.0 cm short axis) and increased to ≥ 1.0 cm short axis during follow-up. At least a 20% increase in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the MSD. In addition, the PBSD must also demonstrate an absolute increase of at least 0.5 cm from the MSD.|Time from registration to the earliest date of documentation of disease progression, assessed at 4 months|Only patients who were evaluable for the primary endpoint were included in the analysis.|||percentage of patients||95% Confidence Interval|Number
2689170|NCT01328496|Secondary|The Number of Participants With Transplant-related Morbidity|Any patient who had adverse events listed either as probable or definite in the first 100 days post-transplant are counted as transplant related morbidity. The number of patients with transplant-related morbidity was given.|first 100 days post transplant||||Participants|||Count of Participants
2689171|NCT01328496|Secondary|Incidence of Transplant-related Mortality (TRM)|TRM is death occurring in patients in continuous complete remission. The numbers of patients with TRM was given.|first 100 days post transplant||||Participants|||Count of Participants
2689511|NCT01326845|Primary|Difference in the Frequency of Overall Newly Occurring GI Adverse Events (AEs) in the Two Treatment Arms|Study was prematurely terminated and not powered for efficacy. Frequency of GI AEs during the overall study period is available in the AE tables reported in the safety section.|3 months|||||||
2689172|NCT01328496|Secondary|Time to Engraftment of Research Arm Participants|Platelet engraftment was defined as platelet count ≥20,000/mm^3 for 3 consecutive tests performed on different days with no platelet transfusions in the preceding 7 days. Neutrophil engraftment will be defined as achieving ANC ≥ 500/mm3 for 3 consecutive tests performed on different days with evidence of donor cell engraftment. Descriptive statistics are provided.|first 100 days post transplant|Those patients who did not reach engraftment are not included in the results provided below.|||Days||Standard Deviation|Mean
2689173|NCT01328496|Secondary|Number of Participants With Chronic GVHD|Due to the small sample size, cumulative incidence analysis was not done. The incidence of chronic GVHD was evaluated using NIH Consensus Global Severity Scoring. The number of patients with incidence of chronic GVHD by severity was provided.|1 year||||Participants|||Count of Participants
2689174|NCT01328496|Secondary|Number of Participants With Acute GVHD|The number of participants with incidence of acute GVHD by grade was given. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe.|1 year||||Participants|||Count of Participants
2689175|NCT01328496|Secondary|Number of Observational Arm Patients With Transplant-related Mortality (TRM)|The number of patients with TRM within the first 100 days post transplant was given.|First 100 days||||Participants|||Count of Participants
2689176|NCT01328496|Secondary|Number of Deaths of Observational Arm Patients|The number of observational arm patients who died was given.|1 year||||Participants|||Count of Participants
2689177|NCT01328496|Secondary|Number of Observational Arm Patients Who Relapsed|The number of observational arm patients who relapsed was given.|1 year||||Participants|||Count of Participants
2689178|NCT01328496|Secondary|Number of Observational Arm Participants Engrafted|For patients enrolled in the observational arm (undergoing a double unit UCBT), the number of patients engrafted was given.|1 year||||Participants|||Count of Participants
2689179|NCT01328496|Primary|Event Free Survival (EFS) for Research Participants|Estimate EFS for research participants at one-year post transplant by using single unit umbilical cord blood. The event is defined as relapse, graft failure, death due to any cause. The number of participants who did not experience any of those events (relapse, graft failure, death due to any cause) at year 1 post-transplant was given.|1 year post-transplant||||Participants|||Count of Participants
2689180|NCT01328444|Secondary|Change From Baseline in 3-hours Post-dose FEV1 at Week 12 of Each Treatment Period|FEVI is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Clinic visit post-dose FEV1 at Week 12 (Treatment Day 85) is defined as the FEV1 value obtained 3 hours after dosing on Treatment Day 85. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions 3 hour post-dose FEV1 measurements were taken electronically by spirometry on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
2689181|NCT01328444|Secondary|Change From Baseline in Residual Volume (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Residual Volume (RV) is defined as the air that remains in the lungs after breathing out as fully as possible. Baseline is the RV value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough RV is measured pre-dose on Treatment Week 12. RV 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. RV measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
2689182|NCT01328444|Secondary|Change From Baseline in Functional Residual Capacity (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Functional Residual Capacity (FRC) is defined as the amount of air still left in the lungs after breathing out normally. Baseline is the FRC value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough FRC is measured pre-dose on Treatment Week 12. FRC 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. FRC measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
2689195|NCT01328405|Secondary|Glottic View|Once the LMA has been placed and secured and the patient is stable from an anesthetic point of view, a flexible fiberoptic camera will be place into the airway tube of the LMA and the view of the patient's vocal cords in relation to the cuff of the LMA will be assessed.|Intraoperative (day 1)||||participants with grade 1 glottic view|||Number
2689512|NCT01326780|Secondary|Percent Change From Baseline in Total Acne Lesion Counts|Percent change in Total Acne Lesion Counts (inflammatory lesions and non-inflammatory lesions)|Baseline through Week 12.||||Percent change||Standard Deviation|Mean
2689183|NCT01328444|Secondary|Change From Baseline in Inspiratory Capacity (Trough and 3-hours Post-dose) at Week 12 of Each Treatment Period|Inspiratory capacity (IC) is defined as the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Baseline is the IC value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Trough IC is measured pre-dose on Treatment Week 12 of each treatment period. IC 3-hours post-dose is measured from the value obtained 3 hours after dosing on Treatment Week 12 of each treatment period. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions. IC measurements were taken electronically by plethysmography on Day 2, Week 6 and Week 12.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
2689184|NCT01328444|Primary|Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Week 12 of Each Treatment Period|FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Day 2, Week 6 and Week 12. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period, mean Baseline is the mean of the Baselines for each participant, and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at Week 12 (Treatment Day 85) is defined as the FEV1 value obtained 24 hours after dosing on Treatment Day 84. Analysis performed using a repeated measures model with covariates of period Baseline, mean Baseline, period, treatment, visit, smoking status, center group, visit by period Baseline, visit by mean Baseline and visit by treatment interactions.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Liters||Standard Error|Least Squares Mean
2689185|NCT01328444|Primary|Change From Baseline in Exercise Endurance Time Post-dose at Week 12 of Each Treatment Period|Exercise endurance time (EET) post-dose at Week 12 is defined as the EET obtained 3 hours after dosing at Week 12. EET was measured using the externally paced field walking test called the endurance shuttle walk test (ESWT). Analysis performed using a repeated measures model with covariates of period walking speed, mean walking speed, period, treatment, visit, smoking status, center group, visit by period walking speed, visit by mean walking speed and visit by treatment interactions. The model used all available 3-hour post-dose change from baseline EET values recorded on Day 2, Week 6 and Week 12. Baseline was the EET assessment obtained prior to dosing on Day 1 of each period. The mean walking speed for each participant is the mean of the levels used for the ESWT in each of the two treatment periods. The period walking speed for each participant and treatment period is the difference between the level for that participant and period and the mean walking speed for that participant.|Week 12 of each treatment period (up to Study Week 29)|Intent-to-Treat (ITT) Population: all par. randomized to treatment who received at least one dose of study drug in either treatment period. Number of par. represent those with data available at the time point; however, all par. in the ITT population without missing covariate information and with at least one post Baseline measurement are included.|||Seconds||Standard Error|Least Squares Mean
2689186|NCT01328431|Secondary|Health Care Service Utilization|A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.|12 months post enrollment|||||||
2689187|NCT01328431|Secondary|Health Care Service Utilization|A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.|3 months post enrollment|||||||
2689188|NCT01328431|Secondary|Self-reported Tobacco Reduction or Abstinence|self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.|12 months post enrollment|||||||
2689189|NCT01328431|Secondary|Health Care Service Utilization|A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups. The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care. The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.|1 month post enrollment|||||||
2689190|NCT01328431|Secondary|Self-reported Tobacco Reduction or Abstinence|self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.|1 month post enrollment|||||||
2689191|NCT01328431|Primary|Self-report of Tobacco Abstinence or Reduction|Questionnaires to assess self reported tobacco abstinence|3 months|This is the # of participants in each group.|||participants|||Number
2689192|NCT01328431|Primary|Biochemical Verification of Tobacco Abstinence|Biochemical verification means a breathalyzer reading for carbon monoxide.|3 months after enrollment|This is the # of participants in each group.|||participants|||Number
2689193|NCT01328405|Secondary|Airway Pathology|The patient will be called 24 hours later by the data collector who will administer a standard oral questionnaire to the patient to determine if a sore throat is present.|Postoperative Day Two||||participants|||Number
2719485|NCT01103778|Secondary|Serum Creatinine|Preservation of renal function will be assessed.|Baseline and 1 year|1 participant lost to followup.|||milligram per deciliter||Full Range|Median
2689196|NCT01328405|Secondary|Grossly Visible Blood or Bile on LMA|At the conclusion of the case, when the patient is breathing on their own and is awake enough, as judged by the anesthesia provider, the LMA will be removed, as would be otherwise done as standard of care. The study LMA will be examined by a data collector for the presence of grossly visible blood or bile, and its presence or absence will be recorded.|Upon LMA removal||||participants|||Number
2689197|NCT01328405|Primary|Airway Seal Pressure|The airway seal pressure will then be assessed by closing the APL valve on the anesthesia machine with a fresh gas flow of 5 liters/minute until an audible leak is observed.|Intraoperative (day 1)||||cmH2O||Standard Deviation|Mean
2689198|NCT01328379|Secondary|Change From Baseline in EQ-5D Visual Analogue Self-rating (VAS) Score at Visit 3.|The EQ-5D is a brief questionnaire that asks patients to rate general state of health. The VAS score rates the general state of health of a patient with 100 for the best imaginable health state and 0 for the worst imaginable health state.|Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)|Full Analysis Population. The number of participants analyzed corresponds with number of subjects who completed the questionnaire in each treatment group.|||units on a scale||Standard Error|Mean
2689199|NCT01328379|Secondary|Change From Baseline in EuroQol Group 5 Dimensions (EQ-5D) Scores at Visit 3.|"Patients completed a brief, generic health status questionnaire: The five specific dimensional scores value patients' health related to mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each question has 3 distinguishable choices that can be analyzed using a 3-point scale (i.e. 1 = no problem, 2=some problems and 3= extreme problems).~A response of 1 indicates that the patient has no problem with the dimension tested and a response of 3 indicates that the patient has extreme problems with the dimension tested. For each visit, the average score of 5 dimensions was calculated by averaging the scores of 5 dimensions. EQ-5D final score ranges from 1-3."|Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)|Full Analysis Population|||units on a scale||Standard Error|Mean
2689200|NCT01328379|Secondary|Change From Baseline in Six-Minute Walk Distance at Visit 2|The Six-Minute Walk, a test of endurance, measures the distance that a patient can walk in a period of 6 minutes. Six-minute walk distance will be reported in feet.|Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period )|Full Analysis Population|||Feet||Standard Error|Mean
2689201|NCT01328379|Secondary|Change From Baseline in MSWS-12 at Visit 2|"The MSWS-12 is a multi-item rating scale that asks patients to rate limitations of their mobility due to MS during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). The scale assesses a range of activities of daily life that rely on walking, such as climbing stairs, moving around the home and walking distances outdoors. The MSWS-12 also addresses the quality of walking, with questions on the smoothness, speed, distance, effort, and mental concentration involved in walking, as well as the need for assistive devices.~For each visit, the MSWS-12 score was calculated by summing the 12 components and transforming into a scale with a range of 0 to 100.~MSWS-12 Score = 100 * [(Sum of Items 1-12) - 12]/48"|Visit 1 (Baseline) and Visit 2 (start of third week double-blind treatment period )|Full Analysis Population|||scores on a scale||Standard Error|Mean
2689202|NCT01328379|Secondary|Change From Baseline in 12-item MS Walking Scale (MSWS-12) at Visit 3|"The MSWS-12 is a multi-item rating scale that asks patients to rate limitations of their mobility due to MS during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). The scale assesses a range of activities of daily life that rely on walking, such as climbing stairs, moving around the home and walking distances outdoors. The MSWS-12 also addresses the quality of walking, with questions on the smoothness, speed, distance, effort, and mental concentration involved in walking, as well as the need for assistive devices.~For each visit, the MSWS-12 score was calculated by summing the 12 components and transforming into a scale with a range of 0 to 100.~MSWS-12 Score = 100 * [(Sum of Items 1-12) - 12]/48"|Baseline Visit 1 (double-blind study day 1) and Visit 3 (end of double-blind week 4)|Full Analysis Population|||scores on a scale||Standard Error|Mean
2689203|NCT01328379|Secondary|Change From Baseline in Walking Speed Near Minimum Plasma Concentration at Steady State (CminSS) of Placebo, Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW).|"The T25FW test is a quantitative measure of ambulatory function that is widely used by MS specialists to assess the global impact of the disease and its progression on the patient's physical disability.~A patient will stand with the toes of his/her shoes on the starting line (identified by a taped mark on the floor) and timing will begin when any part of the patient's foot crosses the tape. Timing will end when any part of the patient's foot crosses the finish line (identified by a taped mark on the floor). Time will be recorded in seconds and rounded to the nearest tenth of a second using a stopwatch provided for this study."|Baseline Visit 1 (double-blind study day 1) and approximately 12 hours post dose at Visit 3 (end of double-blind week 4)|Full Analysis Population|||feet per second||Standard Error|Mean
2689204|NCT01328379|Primary|Change From Baseline in Walking Speed Near Maximum Plasma Concentration at Steady State (CmaxSS) of Placebo and Dalfampridine-ER (5mg and 10mg), Using the Timed 25 Foot Walk (T25FW).|"The T25FW test is a quantitative measure of ambulatory function that is widely used by MS specialists to assess the global impact of the disease and its progression on the patient's physical disability.~A patient will stand with the toes of his/her shoes on the starting line (identified by a taped mark on the floor) and timing will begin when any part of the patient's foot crosses the tape. Timing will end when any part of the patient's foot crosses the finish line (identified by a taped mark on the floor). Time will be recorded in seconds and rounded to the nearest tenth of a second using a stopwatch provided for this study."|Baseline Visit 1 (double-blind study day 1) and approximately 3-4 hours post dose at Visit 3 (end of double-blind week 4)|Full Analysis Population (FAP): All randomized patients who took at least one dose of double-blind investigational medication and who have a baseline Timed 25 Foot Walk (T25FW) assessment and at least one post-baseline T25FW assessment.|||feet per second||Standard Error|Mean
2689205|NCT01328366|Secondary|International Index of Erectile Function Score|The International Index of Erectile Function (IIEF) was a participant-reported questionnaire used to measure a male's erection function. Scores range from 5-75, higher scores indicated better erection quality. Data are reported as the mean IIEF score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Male participants who completed the IIEF questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.|||units on a scale||Standard Deviation|Mean
2723156|NCT01075646|Primary|Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System||48 hours||||mg||Inter-Quartile Range|Median
2689206|NCT01328366|Secondary|Mean Change in Female Sexual Function Index (FSFI) Score From Baseline|The Female Sexual Function Index was a participant-reported questionnaire used to measure a female's sexual function. Scores range from 2-36, higher scores indicated better sexual function. Data are reported as the mean change in FSFI score ± standard deviation.|4 week, 16 weeks, and 6 months following adalimumab initiation|Female participants who completed the FSFI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.|||units on a scale||95% Confidence Interval|Mean
2689207|NCT01328366|Secondary|Female Sexual Function Index (FSFI) Score|The Female Sexual Function Index (FSFI) was a participant-reported questionnaire used to measure a female's sexual function. Scores range from 2-36, higher scores indicated better sexual function. Data are reported as the mean FSFI score ± standard deviation.|Baseline; 16 weeks, and 6 months following adalimumab initiation|Female participants who completed the FSFI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.|||units on a scale||Standard Deviation|Mean
2689208|NCT01328366|Secondary|Change in 12-item Short Form Survey (SF-12) Score From Baseline|The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains. Scores range from 0-100 for each domain, higher scores indicated better physical or mental health. Data are reported as the mean change SF-12 score physical or mental ± standard deviation.|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the SF-12 questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.|||units on a scale||95% Confidence Interval|Mean
2689209|NCT01328366|Secondary|12-item Short Form Survey (SF-12) Score|The 12-item Short Form Survey (SF-12) was a participant-reported questionnaire use to measure the functional health and well-being of a participant to include both physical and mental health domains. Scores range from 0-100 for each domain, higher scores indicated better physical or mental health. Data are reported as the mean SF-12 score physical or mental ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the SF-12 questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.|||units on a scale||Standard Deviation|Mean
2689210|NCT01328366|Secondary|Mean Change in Cutaneous Body Image (CBI) Scale Scores From Baseline|The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant's satisfaction with their hair, nails, and skin. Scores range from 0-9, higher scores indicated a higher level of satisfaction. Data are reported as the mean change in CBI score ± standard deviation.|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the CBI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.|||units on a scale||95% Confidence Interval|Mean
2689211|NCT01328366|Secondary|Cutaneous Body Image Scale (CBI) Scores|The Cutaneous Body Image (CBI) Scale was a participant-reported questionnaire used to measure a participant's satisfaction with their hair, nails, and skin. Scores range from 0-9, higher scores indicated a higher level of satisfaction. Data are reported as the mean CBI score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the CBI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.|||units on a scale||Standard Deviation|Mean
2689212|NCT01328366|Secondary|Mean Change in Hospital Anxiety and Depression Scale (HADS) Scores From Baseline|The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. Data are reported as the mean change in anxiety or depression score ± standard deviation.|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the HADS questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis. HADS-A refers to the anxiety, while HADS-D refers to the depression portion of the survey.|||units on a scale||95% Confidence Interval|Mean
2689213|NCT01328366|Secondary|Hospital Anxiety and Depression Scale (HADS) Scores|The Hospital Anxiety and Depression Scale (HADS) was a patient-reported questionnaire used to assess the level of anxiety and depression in the setting of a hospital medical outpatient clinic. The anxiety and depression subscales each have a range from 0-21, higher scores indicated higher levels of anxiety and depression, respectively. Data are reported as the mean anxiety or depression score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the HADS questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment. HADS-A refers to the anxiety, while HADS-D refers to the depression portion of the survey.|||units on a scale||Standard Deviation|Mean
2689214|NCT01328366|Secondary|Mean Change in Psoriasis Area and Severity Index (PASI) Scores From Baseline|The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores range from 0-72, a higher score indicating more severe psoriasis. Data are reported as the mean change in PASI score ± standard deviation.|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the PASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.|||units on a scale||95% Confidence Interval|Mean
2689215|NCT01328366|Secondary|Psoriasis Area and Severity Index (PASI) Scores|The Psoriasis Area and Severity Index (PASI) questionnaire was used by the clinical staff to measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean PASI score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the PASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment.|||units on a scale||Standard Deviation|Mean
2689216|NCT01328366|Secondary|Mean Change in Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores From Baseline|The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean change in SAPASI score ± standard deviation.|4 weeks, 16 weeks, and 6 months after adalimumab initiation|Participants who completed the SAPASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.|||units on a scale||95% Confidence Interval|Mean
2689217|NCT01328366|Secondary|Self-assessed Psoriasis Area and Severity Index (SAPASI) Scores|The Self-assessed Psoriasis Area and Severity Index (SAPASI) questionnaire was used to objectively measure the severity of a participant's psoriasis, taking into account the area of psoriasis legions on the body and the characteristics of these legions (redness, thickness, scaliness). Scores ranged from 0-72, a higher score indicated more severe psoriasis. Data are reported as the mean SAPASI score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the SAPASI questionnaire at Baseline, 4 Weeks, 16 Weeks, or their 6 Month assessment.|||units on a scale||Standard Deviation|Mean
2689218|NCT01328366|Primary|Mean Change in Dermatology Life Quality Index (DLQI) Scores From Baseline|"The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicated a greater impact on a participant's QOL. Responders to adalimumab had a ≥5 point reduction in DLQI scores or DLQI score of 0. Data are reported as the mean DLQI score ± standard deviation."|4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the DLQI questionnaire at baseline and at the 4 Week, 16 Week, or 6 Month assessment. Participants who did not complete a Baseline and 4 Week, 16 Week, or 6 Month assessment were not included in the analysis.|||units on a scale||95% Confidence Interval|Mean
2689219|NCT01328366|Primary|Dermatology Life Quality Index (DLQI) Scores|The Dermatology Life Quality Index (DLQI) was a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores ranged from 0-30, a higher score indicating a greater impact on a participant's QOL. Data are reported as the mean DLQI score ± standard deviation.|Baseline; 4 weeks, 16 weeks, and 6 months following adalimumab initiation|Participants who completed the DLQI questionnaire at Baseline, 4 Week, 16 Week, or their 6 Month assessment.|||units on a scale||Standard Deviation|Mean
2689220|NCT01328249|Secondary|Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs)|Safety assessments consisted of monitoring and recording all AEs and SAEs, clinical laboratory results, vital signs, physical examinations, Eastern Cooperative Oncology Group (ECOG) performance status, electrocardiograms (ECGs), and left-ventricular ejection fracture (LVEF) by multigated acquisition scan (MUGA) or echocardiogram. An AE was considered a treatment emergent adverse event (TEAE) if the AE onset date was on or after the first dose of study drug and up to 30 days after receiving the last dose of study drug. Treatment-related TEAEs included TEAEs that were considered by the Investigator to be possibly or probably related to eribulin mesylate and/or doxorubicin/cyclophosphamide, or missing causality. Standardized Medical Dictionary for Regulatory Activities Queries (SMQ).|From date of first dose up to 30 days after the last dose of study treatment, or up to approximately 4 years 2 months|The Safety Analysis Set included all participants who were enrolled, received at least 1 dose of study treatments and had at least 1 post-treatment safety assessment. This was the primary analysis set for all safety evaluations including issues related to cyclophosphamide and doxorubicin (AC) or eribulin treatments.|||Participants|||Count of Participants
2689221|NCT01328249|Primary|Percentage of Participants With Feasibility|The regimen was considered feasible if the participant was able to complete the eribulin portion without dose delay or reduction. Dose delay was defined as a delay due to eribulin-related adverse event (AE) for more than 2 days for subsequent doses (cycles after the initiation of full dose of eribulin, except holidays, scheduling difficulties and nonclinical logistical issues). If a participant had more than 1 dose omission, delay or reduction due to eribulin-related AE, these events were collectively counted as one entity in the same participant. Participants were followed for approximately 3 years after the last dose of the study treatment. Feasibility rates were calculated with or without growth factor support. In both cohorts, the percentage of participants who completed the eribulin portion of the regimen without a dose omission, delay or reduction due to eribulin-related AE was estimated via the observed completion rate and an exact 90% confidence interval (CI) was constructed.|From date of first dose, up to 3 years after the last dose of study treatment, or up to approximately 4 years 2 months|The eribulin-treated analysis set included all participants who received at least 1 dose of eribulin mesylate at the starting dose of 1.4 mg/m^2. This was the primary analysis set for the feasibility evaluation.|||Percentage of participants||90% Confidence Interval|Number
2689222|NCT01328184|Secondary|Assessment of Tolerability|Tolerability will be assessed by the investigator according to the categories good, satisfactory, not satisfactory, bad and not assessable.|Within Day 24 to Day 31|Treated set (TS) included all subjects who took at least one dose of study medication.|||percentage of participants|||Number
2689223|NCT01328184|Secondary|Number of Participants With Clinically Relevant Abnormalities in Physical Examination, Vital Signs, ECG and Clinical Laboratory Tests.|Number of participants with clinically relevant abnormalities in physical examination, vital signs and clinical laboratory tests. Relevant findings or worsenings of baseline conditions were reported as adverse events.|Day 1 to day 17|Treated set (TS) included all subjects who took at least one dose of study medication.|||participants|||Number
2689224|NCT01328184|Secondary|Levonorgestrel: Mean Residence Time at Steady State (MRTpo,ss)|Mean residence time of levonorgestrel in the body at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||hours(h)||Geometric Coefficient of Variation|Geometric Mean
2700354|NCT01243320|Primary|Change In Alkaline Phosphatase Blood Level|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.|14 Days||||u/L||95% Confidence Interval|Mean
2689225|NCT01328184|Secondary|Ethinylestradiol: Mean Residence Time at Steady State (MRTpo,ss)|Mean residence time of ethinylestradiol in the body at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||hours(h)||Geometric Coefficient of Variation|Geometric Mean
2689226|NCT01328184|Secondary|Levonorgestrel: Terminal Rate Constant at Steady State (λz,ss)|Terminal rate constant of levonorgestrel in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2689227|NCT01328184|Secondary|Ethinylestradiol: Terminal Rate Constant at Steady State (λz,ss)|Terminal rate constant of ethinylestradiol in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||1/h||Geometric Coefficient of Variation|Geometric Mean
2689228|NCT01328184|Secondary|Levonorgestrel: Terminal Half-life at Steady State (t1/2,ss)|Terminal half-life of levonorgestrel in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||hours(h)||Geometric Coefficient of Variation|Geometric Mean
2689229|NCT01328184|Secondary|Ethinylestradiol: Terminal Half-life at Steady State (t1/2,ss)|Terminal half-life of ethinylestradiol in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||hours(h)||Geometric Coefficient of Variation|Geometric Mean
2689230|NCT01328184|Secondary|Levonorgestrel: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)|Apparent volume of distribution during the terminal phase at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||L||Geometric Coefficient of Variation|Geometric Mean
2689231|NCT01328184|Secondary|Ethinylestradiol: Apparent Volume of Distribution During the Terminal Phase at Steady State (Vz/Fss)|Apparent volume of distribution during the terminal phase at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||L||Geometric Coefficient of Variation|Geometric Mean
2689232|NCT01328184|Secondary|Levonorgestrel: Apparent Clearance at Steady State (CL/Fss)|Apparent clearance of levonorgestrel in the plasma at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2689233|NCT01328184|Secondary|Ethinylestradiol: Apparent Clearance at Steady State (CL/Fss)|Apparent clearance of ethinylestradiol in the plasma at steady state after oral administration|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||mL/min||Geometric Coefficient of Variation|Geometric Mean
2689234|NCT01328184|Secondary|Levonorgestrel: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)|Time from last dosing to the maximum measured concentration of levonorgestrel in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||hours(h)||Full Range|Median
2689235|NCT01328184|Secondary|Ethinylestradiol: Time From Last Dosing to Maximum Measured Concentration (Tmax,ss)|Time from last dosing to the maximum measured concentration of ethinylestradiol in plasma at steady state|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||hours(h)||Full Range|Median
2689236|NCT01328184|Primary|Levonorgestrel: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of levonorgestrel in plasma at steady state over the uniform dosing interval τ.|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||ng/mL||Geometric Coefficient of Variation|Geometric Mean
2689237|NCT01328184|Primary|Ethinylestradiol: Maximum Measured Concentration (Cmax,ss)|Maximum measured concentration of ethinylestradiol in plasma at steady state over the uniform dosing interval τ.|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||pg/mL||Geometric Coefficient of Variation|Geometric Mean
2689238|NCT01328184|Primary|Levonorgestrel: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)|Area under the concentration-time curve of levonorgestrel in plasma at steady state over the uniform dosing interval τ.|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||ng*h/mL||Geometric Coefficient of Variation|Geometric Mean
2689239|NCT01328184|Primary|Ethinylestradiol: Area Under the Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)|Area under the concentration-time curve of ethinylestradiol in plasma at steady state over the uniform dosing interval τ.|Pre-dose, 30 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, and 24h after administration of Microgynon on Days 14 and 21. In addition, pre-dose samples were collected on Days 12, 13, 19, and 20.|Pharmacokinetic (PK) set: Included all subjects who took at least one dose of study medication, who provided evaluable data for at least one primary PK endpoint without important protocol violations.|||pg*h/mL||Geometric Coefficient of Variation|Geometric Mean
2689240|NCT01328158|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Experienced Participants|Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.|Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline HIV-1 RNA value were included in the effectiveness analysis set.|||percentage of participants|||Number
2689241|NCT01328158|Secondary|Percentage of Participants With Plasma HIV-1 RNA Levels Less Than 400 Copies/Milliliter [mL]) by Duration in Treatment-Naive Participants|Participants whose number of plasma HIV-1 RNA copies was less than 400 copies/mL after the start of treatment were handled as responders. For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.|Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline HIV-1 RNA value were included in the effectiveness analysis set.|||percentage of participants|||Number
2689242|NCT01328158|Secondary|Number of Participants in Each CDC Classification Category of HIV-infection Over Time|CDC Categories include Category A: asymptomatic acute phase, Category B: symptomatic other than A or C, and Category C: having an AIDS-indicator disease.|Up to Month 60 after first dose of Lopinavir/Ritonavir|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689243|NCT01328158|Secondary|Mean HIV RNA Amount in Treatment-Experienced Participants at Each Time Point of Observation|For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.|Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline HIV RNA value were included in the effectiveness analysis set.|||Log10 copies/mL||Standard Deviation|Mean
2689244|NCT01328158|Secondary|Mean HIV Ribonucleic Acid (RNA) Amount in Treatment-Naive Participants at Each Time Point of Observation|For subjects with plasma HIV-1 RNA quantified as < 400 copies/mL, the result was recorded as 399 copies/mL.|Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline HIV RNA value were included in the effectiveness analysis set.|||Log10 copies/mL||Standard Deviation|Mean
2689245|NCT01328158|Secondary|Mean CD4 Cell Count in Treatment-Experienced Participants at Each Time Point of Observation||Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline CD4 cell count value were included in the effectiveness analysis set.|||cells/mm^3||Standard Deviation|Mean
2689246|NCT01328158|Secondary|Mean Cluster of Differentiation 4 (CD4) Cell Count in Treatment-Naive Participants at Each Time Point of Observation||Months 0, 3, 6, 9, 12, 24, 36, 48, and 60 after first dosing of Lopinavir/Ritonavir|Participants who had both a baseline and at least one post-baseline CD4 cell count value were included in the effectiveness analysis set.|||cells/mm^3||Standard Deviation|Mean
2689247|NCT01328158|Secondary|Number of Participants With Serious Adverse Events|A serious adverse event is an adverse event that 1. requires in patient hospitalization or prolongation of existing hospitalization, 2. results in persistent or significant disability/incapacity, 3. is life-threatening, 4. results in death, 5. is a congenital anomaly/birth defect, or 6. is an important medical event other than the above.|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689248|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Drugs Other Than Anti-HIV Drugs|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689261|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Allergy|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689249|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Types of Concomitant Anti-HIV Drugs|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown. Abbreviations for the following terminologies are used to represent results in below table: NRTIs: Nucleoside Reverse Transcriptase Inhibitors, NNRTIs: Non-Nucleoside Reverse Transcriptase Inhibitors."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689250|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Non-Drug Treatments|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689251|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Anti-HIV Concomitant Drugs|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689252|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Use Duration of Lopinavir/Ritonavir|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689253|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Mean Daily Dose of Lopinavir/Ritonavir|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689254|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Administration Method of Lopinavir/Ritonavir|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689255|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Center for Disease Control (CDC) Classification Category of Severity Before Treatment|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689256|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia With/Without Hepatitis C|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689257|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Haemophilia|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689258|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Liver Disorder|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689259|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Renal Disorder|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689260|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Concomitant Diseases|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689262|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Past Medical History|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months||||participants|||Number
2689263|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Disease Duration|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689264|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Route of Infection|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689265|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Races|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689266|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Previous Treatment of Human Immunodeficiency Virus (HIV)-Infection|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689267|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Inpatient/Outpatient|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689268|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Age|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689269|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Presence/Absence of Pregnancy|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All female participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689270|NCT01328158|Secondary|Number of Participants With Adverse Drug Reaction by Patient Characteristic: Gender|"Participants with adverse drug reactions were assessed in this study. Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||participants|||Number
2689271|NCT01328158|Primary|Number of Adverse Drug Reactions|"Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period..|||number of adverse drug reaction|||Number
2689272|NCT01328158|Primary|Percentage of Participants With Adverse Drug Reactions|"Adverse Drug Reactions are adverse events for which relationship with Lopinavir/Ritonavir tablets is considered as Related, Relationship cannot be ruled out, and Unknown."|Up to 60 Months|All participants who received Lopinavir/Ritonavir for the treatment of HIV infection in institutions participating in the HRD Cooperative Survey during the registration period.|||percentage of participants|||Number
2689273|NCT01328080|Primary|Percentage Change in Total AKN Lesions From Baseline to Week 16.|To determine if treatment of AKN with targeted ultraviolet B radiation will improve the clinical appearance of lesions.|Baseline to Week 16||||percentage of lesion count reduction||Full Range|Mean
2689281|NCT01328054|Secondary|Mean Calcium, Chloride, Carbon Dioxide (CO2), Potassium, Sodium, Magnesium and Urea at the Indicated Time Points|Blood samples were collected for the measurement of calcium, chloride, CO2, potassium, sodium, magnesium and urea at Baseline; at Days 5 and 8-11. Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.|||Millimoles per liter (mmol/L)||Standard Deviation|Mean
2689513|NCT01326780|Secondary|Percent Change From Baseline in the Inflammatory Acne Lesion Counts|Percent Change in Inflammatory Acne Lesion Counts (sum of of papules and pustules)|Baseline through Week 12||||Percent change||Standard Deviation|Mean
2689274|NCT01328054|Secondary|Median Time to Cmax (Tmax) and the Time Prior to the First Quantifiable (Non-zero) Lapatinib Plasma Concentration (Tlag) Following the Last (3rd) Lapatinib Dose|For each participant, the time at which Cmax was observed (tmax) was determined directly from the raw concentration-time data. For each participant, the time prior to the first quantifiable (non-zero) concentration (tlag) was determined directly from the raw concentration-time data. Since all participants received 2 doses of study medication prior to the collection of the first (pre-dose) blood sample on Day 4, tlag was expected to be zero. For PK analysis, one blood sample was collected on Day 1 for placebo Baseline. The 24 hour blood sample on Day 2 also served for lapatinib Baseline. Pre-dose blood samples were collected 30 minutes prior to the administration of study medication on Day 2 (placebo) and Day 4 (lapatinib). Serial blood samples were collected on Day 2 (for placebo) and on Day 4 (for lapatinib) at the following post-last-dose time points 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours.|Day 1 pre-dose; on Day 2 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose), and on Day 4 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose)|PK Population|||Hours||Full Range|Median
2689275|NCT01328054|Secondary|Mean Maximum Plasma Concentration (Cmax) and Observed Plasma Concentration at 24 Hours Post-dose (C24) of Lapatinib|The first occurrence of Cmax and C24 was determined directly from the raw concentration-time data. For PK analysis, one blood sample was collected on Day 1 for placebo Baseline. The 24 hour blood sample on Day 2 also served for lapatinib Baseline. Pre-dose blood samples were collected 30 minutes prior to the administration of study medication on Day 2 (placebo) and Day 4 (lapatinib). Serial blood samples were collected on Day 2 (for placebo) and on Day 4 (for lapatinib) at the following post-last-dose time points 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours.|Day1 pre-dose; on Day 2 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose), and on Day 4 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose)|PK Population|||Nanograms per mL||Geometric Coefficient of Variation|Geometric Mean
2689276|NCT01328054|Secondary|Mean Area Under the Plasma Drug Concentration-time Curve (AUC) From Time Zero (Pre-dose) to the Last Time of Quantifiable Concentration (AUC[0-t]) and From Time Zero (Pre-dose) to 24 Hours Post Dose (AUC[0-24]) for Lapatinib|AUC is defined as the area under the lapatinib concentration-time curve as a measure of drug exposure. AUC(0-t) and AUC(0-24) were determined from the plasma concentration-time data using the linear trapezoidal rule for increased concentrations and the logarithmic trapezoidal rule for decreased concentrations. For PK analysis, one blood sample was collected on Day 1 for placebo Baseline. The 24 hour blood sample on Day 2 also served for lapatinib Baseline. Pre-dose blood samples were collected 30 minutes prior to the administration of study medication on Day 2 (placebo) and Day 4 (lapatinib). Serial blood samples were collected on Day 2 (for placebo) and on Day 4 (for lapatinib) at the following post-last-dose time points 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours.|Day 1 pre-dose; on Day 2 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-last-dose), and on Day 4 (at pre-dose, then 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-last-dose)|Pharmacokinetic (PK) Population: all participants in the ATS Population for whom at least one PK sample was obtained and analyzed. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.|||Nanograms hour per milliliter||Geometric Coefficient of Variation|Geometric Mean
2689277|NCT01328054|Secondary|Number of Participants With 12-lead ECG Findings at Indicated Time Points|The number of participants with the 12-lead ECG findings normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) are reported. Clinical significance was based on the medical and scientific judgement of the investigator or qualified designee. A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at Baseline; on Day 1 (at pre-dose); on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post-last- dose); on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post-last-dose); at the End of Study visit (Day 8-11); and at the post-treatment Follow-up visit (if applicable).|BL;Day 1 (at pre-dose);Day 2 (at pre-dose, 4, 8, 12 and 24 hr post dose);Day 4 (at pre-dose, 4, 8, 12 and 24 hr post dose);End of Study visit (Day 8-11); and Follow-up (within approx 28 days following last dose of study trt [up to end of Study Week 4])|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.|||Participants|||Number
2689278|NCT01328054|Secondary|Change From Baseline in Heart Rate at the Indicated Time Points|Heart rate were measured at Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post dose. Baseline is defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post dose|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.|||Beats per minute||Standard Deviation|Mean
2689279|NCT01328054|Secondary|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points|Blood pressure measurements included SBP and DBP and were obtained at Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post dose). Baseline is defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; on Day 2 (at pre-dose, 4, 8, 12 and 24 hours post-dose), and on Day 4 (at pre-dose, 4, 8, 12 and 24 hours post-dose)|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.|||Millimeter of mercury (mmHg)||Standard Deviation|Mean
2689280|NCT01328054|Secondary|Mean Total Neutrophils (ANC [Absolute Neutrophil Count]), Platelets and Leukocyte Count at the Indicated Time Points|Blood samples were collected for the measurement of total neutrophils (ANC), platelets, and leukocyte count at Baseline; Days 5 and 8-11. Baseline was defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.|||10^9 cells per liter (GI/L)||Standard Deviation|Mean
2689447|NCT01327313|Primary|Total Body Clearance (CL) of EMD 525797: After Single Dose|Total body clearance of drug in serum was calculated: as CL= Dose divided by Area under the serum concentration-time curve from time zero to infinity (AUC0-inf).|Pre-dose, hour 1 (EOI), 4, 8, 24, 48, and 96 hours after start of infusion at Week 1|The PK analysis set included all subjects who received at least the first dose of the study drug and who provided sufficient data for a concentration-time profile for EMD 525797.|||liter per hour||Geometric Coefficient of Variation|Geometric Mean
2689282|NCT01328054|Secondary|Mean Direct Bilirubin, Total Bilirubin, and Creatinine at the Indicated Time Points|Blood samples were collected for the measurement of direct bilirubin, total bilirubin, and creatinine at Baseline; Days 5 and 8-11; Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.|||Micromoles per liter (µmol/L)||Standard Deviation|Mean
2689283|NCT01328054|Secondary|Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), and Aspartate Aminotransferase (AST) at the Indicated Time Points|Blood samples were collected for the measurement of ALP, ALT, and AST at Baseline; Days 5 and 8-11. Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.|||International units per liter (IU/L)||Standard Deviation|Mean
2689284|NCT01328054|Secondary|Mean Albumin, and Hemoglobin at the Indicated Time Points|Blood samples were collected for the measurement of albumin and hemoglobin at Baseline; Days 5 and 8-11. Baseline is defined as the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date.|Baseline; Day 5 and end of study visit on Day 8-11|ATS Population. Only participants available at the specified time point (represented as n=X in the category title) were analyzed.|||Grams per liter (g/L)||Standard Deviation|Mean
2689285|NCT01328054|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect, or is an important medical eventsthat jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, new primary cancers, liver events, cardiac dysfunction, pneumonitis, and laboratory abnormalities.|From the start of study treatment until follow-up (within approximately 28 days following the last dose of study medication [up to end of Study Week 4])|ATS Population|||Participants|||Number
2689286|NCT01328054|Secondary|Number of Participants With the Worst-case Post-Baseline 12-lead Holter ECG Findings With Significant ST, T Wave, and U Wave Abnormalities|Abnormal ECG findings or change in ECG morphological patterns were based on the ECG interpretations provided by the ECG core lab. Three replicate Holter ECGs were collected at 30, 15, and 0 minutes prior to the administration of study treatment on Days 1 (Baseline for placebo) and 3 (Baseline for lapatinib) and pre-dose and 1, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Days 2 and 4. The three readings at each time point were averaged prior to any analysis. Baseline is the pre-dose ECGs (triplicate) taken on Day 1 for placebo and Day 3 for lapatinib. The number of participants with the worst-case post-Baseline 12-lead Holter ECG findings with significant ST, T wave, and U wave abnormalities were analyzed.|Baseline (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 2 for placebo. Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib.|Pharmacodynamic (PD) Population: all participants from the All Treated Subjects Population (ATS) who completed the ECG acquisition via Holter monitoring of at least one time point on Days 1, 2, 3 and 4.|||Participants|||Number
2689287|NCT01328054|Secondary|Number of Participants With 12-lead Holter ECG Findings at the Indicated Time Points|The number of participants with 12-lead Holter ECG findings of normal (NL), abnormal not clinically significant (Abn NCS), and abnormal clinically significant (Abn CS) are reported. Abnormal ECG findings or change in ECG morphological patterns were based on the ECG interpretations provided by the ECG core lab. Three replicate 12-lead Holter ECGs were collected at -30, -15, and 0 minutes prior to the administration of study treatment on Days 1 (Baseline for placebo) and 3 (Baseline for lapatinib) and pre-dose and 1, 2, 3, 4, 6, 8, 10,12, and 24 hours post dose on Days 2 and 4. The three readings at each time point were averaged prior to any analysis. Baseline is the pre-dose ECGs (triplicate) taken on Day 1 for placebo and on Day 3 for lapatinib.|Baseline (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 2 for placebo. Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib.|Evaluable Population. Only participants available at the specified time point (represented as n=X, X in the category title) were analyzed.|||Participants|||Number
2689288|NCT01328054|Secondary|Change From Baseline in the Holter ECG Parameters of QT Interval, Corrected QT Interval (QTc), Bazett Corrected QTc Interval (QTcB), Individual-corrected QT Interval (QTcI), RR Interval, PR Interval, and QRS Duration at Indicated Time Points|A Holter monitor is an ambulatory portable device for continuously monitoring the cardiovascular system. Change from Baseline in QT interval, QTc interval, QTcB interval, QTcI interval, RR interval, PR interval, and QRS duration at each time point for lapatinib was assessed in comparison with time-matched placebo. Three replicate ECGs were collected at 30, 15, and 0 minutes prior to the administration of study treatment on Days 1 and 3 and pre-dose and 1, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Days 2 and 4. The three readings at each time point were averaged prior to any analysis. Baseline is the average of the pre-dose ECGs (triplicate) taken on Day 1 for placebo and Day 3 for lapatinib. Change from Baseline was calculated by subtracting the Baseline values from individual post-Baseline values for each time point.|Baseline (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 2 for placebo. Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib.|Evaluable Population. Only participants available at the specified time point (represented as n=X, X in the category title) were analyzed.|||Milliseconds||Standard Deviation|Mean
2689312|NCT01327989|Secondary|Immediate Flow Reperfusion|"Immediate reperfusion observed when the Solitaire™ FR device is deployed within the thrombus - Thrombolysis in Cerebral Infarction (TICI) score 2b or 3.~Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion"|procedure|Due to insufficient imaging, the Core Lab was able to evaluated data from 190 subjects.|||percentage of participants|||Number
2689289|NCT01328054|Primary|Treatment Difference in Duration of Cardiac Ventricular Depolarization and Repolarization Interval (QT) in Fridericia-corrected QT Interval (QTcF) Values Between Placebo and Lapatinib 2000mg|A Holter monitor is an ambulatory portable device used for continuously monitoring the cardiovascular system. Three replicate electrocardiograms (ECGs) were collected at 30, 15, and 0 minutes prior to the administration of study treatment (trt) on Days 1 and 3 and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 2 and 4. The 3 readings at each time point (TP) were averaged prior to any analysis. BL is the average of the pre-dose QTcF values (triplicate) taken on Day 1 for PBO and on Day 3 for LAP. Mean change from BL was calculated by subtracting the BL values from individual QTcF for each TP. BL adjusted mean difference in absolute QTcF between LAB and PBO (trt difference) with the corresponding 90% confidence interval (CI) was estimated for each TP (pre-dose and 1, 2, 3, 4, 6, 8, 10, 12, and 24-hr post-dose). Trt difference analysis was performed by a repeated measures analysis of variance adjusted for trt group, TP, and trt group*TP interaction.|Baseline (BL) (Day1) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours (hr) post-dose on Day 2 for placebo (PBO). Baseline (Day 3) and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24-hours post-dose on Day 4 for lapatinib (LAP).|Evaluable Population: all participants in the All-Treated Subjects (ATS) Population who met the criteria for dosing compliance, ECG acquisition, and Baseline ECG acquisition. The ATS Population is comprised of all participants who received at least one dose of study medication (placebo or lapatinib).|||Milliseconds||Standard Error|Least Squares Mean
2689290|NCT01328041|Secondary|Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) Between Baseline and the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance|The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF is defined as a <0.5 log10 copies/mL decrease in plasma HIV-1 RNA at Day 8 unless the absolute value is <400 copies/mL. PDVF after Day 8 was defined for virological non-response (decrease in plasma HIV-1 RNA of less than 1 log10 copies/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA <400 copies/mL and confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24) and virological rebound (confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL and confirmed plasma HIV-1 RNA levels >1 log10 copies/mL above the nadir value, where nadir is >=400 copies/mL).|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|PDVF Phenotypic Resistance Populations. Only participants with Baseline DTG IC50 with PDVF who had paired Baseline and time of virological failure samples were considered for analysis.|||Participants|||Number
2689291|NCT01328041|Secondary|Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF) as a Measure of Genotypic Resistance|An analysis of changes at specific amino acids in the IN coding region associated with resistance to raltegravir, elvitegravir, or DTG was performed at Day 1 and at the time of PDVF. PDVF is a <0.5 log10 copies(c)/mL decrease in plasma HIV-1 RNA at Day 8 unless the absolute value is <400 c/mL. PDVF after Day 8 is defined as virological non-respones (decrease in plasma HIV-1 RNA of <1 log10 c/mL by Week 16, with subsequent confirmation, unless plasma HIV-1 RNA <400 c/mL and confirmed plasma HIV-1 RNA levels >=400 c/mL on or after Week 24) and virological rebound (confirmed rebound in plasma HIV-1 RNA levels to >=400 c/mL after prior confirmed suppression to <400 c/mL and confirmed plasma HIV-1 RNA levels >1 log10 c/mL above the nadir value [nadir: >=400 c/mL]).|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|PDVF Genotypic Resistance Populations: all participants in the ITT-E Population with available on-treatment genotypic resistance data at the time of PDVF. Only participants with Baseline IN mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.|||participants|||Number
2689292|NCT01328041|Secondary|C0 Assessment of DTG|The plasma DTG concentration immediately prior to dosing at steady state (C0) was assessed at Day 8, Week 4, and Week 24. Blood samples for pharmacokinetic assessments were collected pre-dose and 1-3 hours post-dose on Day 8 and at Week 4 and 4-12 hours post-dose at Week 24. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Pharmacokinetic Parameter Population.|Day 8, Week 4, and Week 24|Pharmacokinetic (PK) Parameter Population: all participants who received DTG, underwent PK sampling during the study, and provided an evaluable estimate of C0. Only participants with data available at the indicated time points were considered for analysis.|||µg/mL||Geometric Coefficient of Variation|Geometric Mean
2689293|NCT01328041|Secondary|AUC(0-tau) and AUC(0-24) of DTG|The area under the time concentration curve over the dosing interval (AUC[0-tau]) and from 0 to 24 hours (AUC[0-24]) of DTG was assessed by a population PK modeling approach using pooled DTG PK data from multiple studies. For this study, blood samples for pharmacokinetic assessments were collected pre-dose on Day 8 and at Weeks 4 and 24, at 1-3 hours post-dose on Day 8, and at 1-3 hours or 4-12 hours post-dose at Weeks 4 and 24.|Day 8, Week 4, and Week 24|The Pharmacokinetic (PK) Concentration Population: all subjects who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.|||µg*hour/mL||95% Confidence Interval|Geometric Mean
2689294|NCT01328041|Secondary|Cmax and Ctau of DTG|The maximum plasma concentration (Cmax) and the concentration at the end of a dosing interval (Ctau) of DTG were assessed by a population pharmacokinetic (PK) modeling approach using pooled DTG PK data from multiple studies. For this study, blood samples for pharmacokinetic assessments were collected pre-dose on Day 8 and at Weeks 4 and 24, at 1-3 hours post-dose on Day 8, and at 1-3 hours or 4-12 hours post-dose at Weeks 4 and 24.|Day 8, Week 4, and Week 24|The Pharmacokinetic (PK) Concentration Population: all subjects who received DTG, had undergone PK sampling during the study, and provided evaluable DTG plasma concentration data.|||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
2689343|NCT01327846|Primary|Analysis of Core Phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and Its Components|"Time to occurrence of CEC (Cardiovascular clinical events adjudication committee) confirmed MACE, which was a composite endpoint consisting of CEC confirmed CV death, CEC confirmed non-fatal MI,or CEC confirmed non-fatal stroke. Patients with the CEC adjudicated reason for death of Unknown were counted as CV (cardiovascular) death."|From randomization, to end of treatment plus 30 days, up to approximately 6 years|Full Analysis Set (FAS): All randomized patients except for those who were misrandomized or from sites with serious GCP violations|||Participants|||Number
2689295|NCT01328041|Secondary|Number of Participants With HIV-1 Disease Progression (Acquired Immune Deficiency Syndrome [AIDS] or Death)|The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|ITT-E Population|||Participants|||Number
2689296|NCT01328041|Secondary|Ratio of CD4+/CD8+ Cell Count at Baseline and Weeks 4, 12, 24, and 48|The ratio of CD4+/CD8+ cell count (measured in cells/mm^3) was assessed at Baseline and at Weeks 4, 12, 24, and 48. The ratio was calculated as the CD4+ cell count divided by CD8+ cell count.|Baseline; Weeks 4, 12, 24, and 48|ITT-E Population. Only those participants with data available at the indicated time points were considered for analysis (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.|||ratio||Inter-Quartile Range|Median
2689297|NCT01328041|Secondary|Median Change From Baseline in CD4+ Cell Counts at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks Until Study Completion|Median change from Baseline in CD4+ cell counts was assessed at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180. v|ITT-E Population. Only those participants with data available at the indicated time points were considered for analysis (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.|||Cells per millimeters cubed (cells/mm^3)||Inter-Quartile Range|Median
2689298|NCT01328041|Secondary|Absolute Values for CD4+ Cell Counts at Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48 and for CD8+ Cell Counts at Baseline and Weeks 4, 12, 24, and 48|Absolute values for CD4+ cell counts were assessed at Baseline, Day 8 and Weeks 4, 8, 12, 16, and 24, and absolute values for CD8+ cell counts were assessed at Baseline and Weeks 4, 12, 24, and 48.|Baseline, Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and 48|ITT-E Population. Only those participants with data available at the indicated time points were considered for analysis (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.|||Cells per millimeters cubed (cells/mm^3)||Inter-Quartile Range|Median
2689299|NCT01328041|Secondary|Mean Change From Baseline in Plasma HIV-1 RNA at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study Completion|Mean change from Baseline in plasma HIV-1 RNA was assesseed at Day 8 and Weeks 4, 8, 12, 16, 24, 32, 40, 48 , 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, and 180 using data of the observed cases. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.|Baseline; Day 8; Weeks 4, 8, 12, 16, 24, 32, 40, and From Week 48 Every 12 Weeks up to Study completion (Up to Week 180)|ITT-E Population. Only those participants with data available at the indicated time points were considered for analysis (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.|||Log10 copies/mL||Standard Deviation|Mean
2689300|NCT01328041|Secondary|Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL From Week 48 Every 12 Weeks up to Study Completion|The number of participants with plasma HIV-1 RNA less than 400 and 50 copies (c)/mL was assessed at Weeks 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168 and 180 using data of observed cases. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).|From Week 48 every 12 weeks up to study completion.|ITT-E Population|||Participants|||Number
2689301|NCT01328041|Secondary|Number of Participants With Plasma HIV-1 RNA Less Than 400 and 50 Copies/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48|The number of participants with plasma HIV-1 RNA less than 400 and 50 copies (c)/mL at Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40 and 48 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the par. was on treatment within the VOI analysis window|Baseline; Day 8; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48|ITT-E Population|||participants|||Number
2689302|NCT01328041|Primary|Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade|The severity of hematology toxicities was graded according to the DAIDS. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|Safety Population|||Participants|||Number
2689303|NCT01328041|Primary|Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade|The severity of clinical chemistry toxicities was graded according to the DAIDS toxicity scale. The DAIDS displays events as Grades 1-5 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|Safety Population|||participants|||Number
2689304|NCT01328041|Primary|Number of Participants With Adverse Events of the Indicated Severity, Per the Division of Acquired Immune Deficiency Syndrome (DAIDS) Grading Scale|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. AE/SAE severity was graded according to the DAIDS grading scale. The DAIDS displays events as Grades 1-4 based on this general guideline: Grade (G) 1, mild; G2, moderate; G3, severe; G4, potentially life threatening.|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|Safety Population|||participants|||Number
2689305|NCT01328041|Primary|Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury.|From the day of the first dose of study drug until end of treatment visit for each participant, up to Week 180 (median of 758 days)|Safety Population: all participants who received at least one dose of study drug|||participants|||Number
2689306|NCT01328041|Primary|Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48|The number of participants who had viral load <50 copies/mL at Week 48 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.|Week 48|ITT-E Population|||participants|||Number
2689307|NCT01328041|Primary|Number of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 24|The number of participants who had viral load <50 copies/mL at Week 24 based on the Food and Drug Administration's Snapshot algorithm was assessed. This algorithm treats all participants without HIV-1 RNA data at the visit of interest (VOI [due to missing data/discontinuation of investigational product prior to the visit window]) as nonresponders, as well as participants who switched their concomitant antiretroviral (ART) prior to the VOI as follows: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol, however the decision to switch was not documented as being before or at the first on-treatment visit after switching to optimized background regimen (i.e., Week 4) where HIV-1 RNA was assessed. Otherwise, virologic success/failure was to be determined by the last available HIV-1 RNA assessment while the participant was on treatment within the VOI analysis window.|Week 24|ITT-E Population|||participants|||Number
2689308|NCT01328041|Primary|Mean Change From Baseline in Plasma HIV-1 RNA at Day 8|Mean change from Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Day 8 was calculated as the Day 8 value minus the Baseline value. The last observation was carried forward if a participant had missed the Day 8 visit. The Baseline observation was carried forward if a participant had discontinued the treatment before Day 8. Blood samples for assessment of HIV-1 RNA levels were collected at Baseline and Day 8.|Baseline and Day 8|Intent-to-Treat-Exposed (ITT-E) Population: all participants who received at least one dose of study drug. Only participants who had Day 8 observations were considered for analysis.|||log10 copies/milliliter (mL)||Standard Deviation|Mean
2689309|NCT01328002|Secondary|Patient Global Impression of Severity (PGIS)|"The wording of the PGIS assessment was as follows: Considering all aspects of your illness, how do you evaluate the severity of your fibromyalgia? The possible responses to this question were 1. Normal, not at all ill 2. Borderline ill 3. Mildly ill 4. Moderately ill 5. Severely ill 6. Extremely ill"|Change from Visit 7 (Week 8) to Visit 10 (Week 16)|The Open-Label Safety Population consists of 116 patients who took at least 1 dose of open-label milnacipran. 20 patients were randomized to a treatment group (Randomized Population) took at least 1 dose of double-blind treatment (Double-blind Safety Population) and were analyzed as randomized (Double-blind Intent-to-Treat [ITT] Population).|||units on a scale||Standard Deviation|Mean
2689310|NCT01328002|Primary|Time to First Loss of Therapeutic Response (LTR) Following Randomization to Milnacipran or Placebo.|During the open-label period, 20 patients out of 116 enrolled had a reduction from baseline (Visit 2) of at least 50% in their pain, were classified as responders and were randomized (Visit 7). A Loss of Therapeutic Response was said to occur if, during the double-blind treatment period, any of the following occurred: • A worsening of fibromyalgia requiring an alternate treatment OR • An increase in 1-week mean of daily pain ratings (11-point numeric rating scale) to greater than 70% of Baseline (Visit 2) OR • Withdrawal from the study for any reason except withdrawals due to extenuating circumstances|Change from Visit 7 (Week 8) to Visit 10 (Week 16)|The Open-Label Safety Population consists of 116 patients who took at least 1 dose of open-label milnacipran. 20 patients who were randomized to a treatment group (Randomized Population) took at least 1 dose of double-blind treatment (Double-blind Safety Population) and were analyzed as randomized (Double-blind Intent-to-Treat [ITT] Population).|||Days||Standard Deviation|Mean
2689311|NCT01327989|Primary|Incidence of Device-related and Procedure-related Serious Adverse Events (SAEs).|Device-related and procedure-related Serious Adverse Events (SAEs). A clinically significant procedure complication is defined as a decline in NIHSS of ≥4 or access vessel complication requiring surgery or blood transfusion.|90 Days||||percentage of events|||Number
2689313|NCT01327989|Secondary|Incidence of Symptomatic Intracranial Hemorrhage|"Symptomatic intracranial hemorrhage, defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a decline in National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24 hrs.~PH1 - Hematoma within ischemic field with some mild space occupying effect but involving ≤ 30% PH2 - Hematoma within ischemic field with space-occupying effect involving > 30% of the infarcted area RIH - Any intraparenchymal hemorrhage remote from the ischemic field IVH - Intraventricular hemorrhage SAH - Subarachnoid hemorrhage"|24 hours||||percentage of particpants|||Number
2689314|NCT01327989|Secondary|Rate of Mortality||90 Days||||percentage of particpants|||Number
2689315|NCT01327989|Secondary|Rate of Morbidity||90 Days||||percentage of particpants|||Number
2689316|NCT01327989|Secondary|Good Neurological Condition|Good neurological outcome (GNO), as defined in the protocol, is a modified Rankin Scale (mRS) score of less than or equal to 2, or National Institutes of Health Stroke Scale (NIHSS) score 0-1, or NIHSS score improvement of 10 points or more from the pre-procedure evaluation|90 Days|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.|||percentage of particpants|||Number
2689317|NCT01327989|Secondary|Time to Achieve Revascularization - After First Ipsilateral Angiogram to Final Solitaire™ FR Angiogram|"Time after first ipsilateral angiogram to final Solitaire™ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow~Thrombolysis in Cerebral Infarction (TICI) score~Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion"|During Procedure|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.|||Minutes||Standard Deviation|Mean
2689318|NCT01327989|Secondary|Time to Achieve Revascularization - Groin Stick to Initial Angiogram and Final Solitaire™ FR Angiogram|"Time from groin stick to initial angiogram and final Solitaire™ FR angiogram with Thrombolysis in Cerebral Infarction (TICI) score 2b or 3 flow~Thrombolysis in Cerebral Infarction (TICI) score~Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion"|During procedure|Unavailability of data contributed to fewer subjects analyzed compared to the cohort sample size.|||Minutes||Standard Deviation|Mean
2689319|NCT01327989|Primary|Arterial Recanalization of the Occluded Target Vessel Measured by Thrombolysis in Cerebral Infarction (TICI) Score Equal or Superior to 2b Following the Use of the Study Device.|"Thrombolysis in Cerebral Infarction (TICI) score~Grade 0- No perfusion Grade 1- Penetration with Minimal Perfusion Grade 2- Partial Perfusion Grade 2a- Only partial filling (<2/3) of the entire vascular territory is visualized Grade 2b - Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal Grade 3- Complete Perfusion"|Immediately post procedure|Due to insufficient imaging, the Core Lab was able to evaluate data from 190 subjects.|||percentage of particpants|||Number
2689320|NCT01327976|Primary|Percentage Responder Rate in the Treatment Arm.|The second co-primary effectiveness endpoint was based on responder rates with the following two requirements: (i) at least 55% of vBloc subjects would achieve a %EWL of at least 20%; and (ii) at least 45% of vBloc subjects would achieve a %EWL of at least 25%.|12 months||||percentage of subjects|||Number
2689321|NCT01327976|Primary|Percentage of Excess Weight Loss (EWL) by Body Mass Index (BMI) Method.|Observe at least a 10% greater excess body weight loss (EWL) from randomization with the Maestro System after 12 months of vBloc Therapy compared to Sham by body mass index (BMI) method. (Body mass index is calculated by dividing body weight (kg) by body height (m) squared (BMI=kg/m2)).|12 months||||percentage of excess weight loss||95% Confidence Interval|Mean
2689322|NCT01327976|Primary|Percentage of Subjects Experiencing Implant/Revision Procedure, Device or Therapy Related Serious Adverse Events (SAEs).|To demonstrate that the implant/revision procedure, device and therapy related serious adverse event rate in the vBloc group at 12 months post-implant is significantly lower than 15%.|12 months|An intent-to-treat analysis was performed in the vBloc group.|||percentage of participants||95% Confidence Interval|Number
2689323|NCT01327885|Secondary|Clinical Benefit Rate (CBR)|CBR was defined as the percentage of participants who have best overall response (BOR) of CR, or PR, or duration of stable disease (dSD) greater than or equal to 11 weeks, between Arm A and Arm B. CBR was estimated by treatment arm based on the tumor response evaluation performed by the PI or designee according to RECIST 1.1. CR was defined as disappearance of all target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter.|From date of treatment start (Day 1) until disease progression, development of unacceptable toxicity, withdrawal of consent, participant's choice to stop study treatment, or up to data cutoff (02 Jan 2015), for up to approximately 3 years 11 months|FAS (ITT analysis set) included all participants who were randomized.|||Percentage of participants||95% Confidence Interval|Number
2689324|NCT01327885|Secondary|Progression-Free Rate at 12 Weeks (PFR12wks)|The PFR12wks was defined as the percentage of participants who were still alive without disease progression at 12 weeks from the date of randomization. Tumor assessment by the investigator or designee was based on RECIST criteria 1.1.|From date of treatment start until Week 12|FAS (ITT analysis set) included all participants who were randomized.|||Percentage of participants||95% Confidence Interval|Number
2689325|NCT01327885|Secondary|Progression-Free Survival (PFS)|PFS was defined as the time from the date of randomization to the date of first documentation of disease progression, or date of death (whichever occurred first). The date of disease progression was defined as the date of radiologic disease progression as assessed by the investigator or designee based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Participants who did not have an event (i.e., participants who were lost to follow-up or who did not progress or die at the date of data cut-off), were censored. Participants who discontinued study treatment without disease progression were censored on the date of their last radiological assessment (scan date).|Randomization (day 1) to the date of first documentation of disease progression, or date of death (whichever occurred first)|FAS (ITT analysis set) included all participants who were randomized.|||Months||95% Confidence Interval|Median
2689326|NCT01327885|Primary|Overall Survival (OS)|OS was defined as the time in months from the date of treatment start until death, regardless of cause. In the absence of confirmation of death, participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. Participants who died on the date of randomization had a survival time of 0.5 day. Allocation of randomization numbers were performed based upon the following stratification factors: (a) Histology (ADI or LMS), (b) Region (Region 1: USA and Canada; or Region 2: Western Europe, Australia, Israel; or Region 3: Eastern Europe, Latin America, and Asia), and (c) Number of prior regimens for advanced soft tissue sarcoma (STS) (2 or >2 prior regimens).|From date of treatment start until date of death from any cause, assessed up to data cutoff date (02 Jan 2015), for up to approximately 3 years 11 months|Full analysis set (FAS) (Intent-to-Treat (ITT) analysis set) included all participants who were randomized.|||Months||95% Confidence Interval|Median
2689327|NCT01327846|Secondary|Substudy 2 (Core Phase): Change From Baseline in OGTT Stimulated Area Under the Curve (AUC) 0-120 Min of C-peptide Concentration||From randomization up to approximately 6 years|Data from subjects were not collected as the substudy was terminated prior to data collection.||||||
2689328|NCT01327846|Secondary|Substudy 2 (Core Phase): Change From Baseline in Fasting Pro-Insulin Concentration/Insulin Concentration Ratio||From randomization up to approximately 6 years|Data from subjects were not collected as the substudy was terminated prior to data collection.||||||
2689329|NCT01327846|Secondary|Substudy 2 (Core Phase): Change From Baseline in OGTT Stimulated Area Under Curve (AUC) 0-120 Min of Glucose Concentration, Insulin Concentration, Pro-insulin Concentration, and Insulin Concentration/Glucose Concentration Ratio||From randomization up to approximately 6 years|Data from subjects were not collected as the substudy was terminated prior to data collection.||||||
2689330|NCT01327846|Secondary|Substudy 2 (Core Phase): Change From Baseline in Insulin Sensitivity Index||From randomization up to approximately 6 years|Data from subjects were not collected as the substudy was terminated prior to data collection.||||||
2689331|NCT01327846|Secondary|Substudy 1 (Core Phase): The Existence of a Baseline Total Vessel Wall Area by Treatment Interaction as Well as the Consistency of the Treatment Effect Across Subgroups||24 months|Data from subjects were not collected as the substudy was terminated prior to data collection.||||||
2689332|NCT01327846|Secondary|Substudy 1 (Core Phase): Change From Baseline in Corresponding Total Vessel Wall Area in the Left and Right Carotid Arteries||24 months|Data from subjects were not collected as the substudy was terminated prior to data collection.||||||
2689333|NCT01327846|Secondary|Substudy 1 (Core Phase): Mean Total Vessel Wall Area Across the Left and Right Carotid Artery at Month 3 and Month 24||24 months|Data from subjects were not collected as the substudy was terminated prior to data collection.||||||
2689334|NCT01327846|Secondary|Substudy 1 (Core Phase): Change From Baseline of the Total Vessel Wall Area at Month 3 in the Bifurcation Region of the Index Carotid Artery||3 months|Data from subjects were not collected as the substudy was terminated prior to data collection.||||||
2689335|NCT01327846|Secondary|Summary of Adverse Events (Extension Phase)|Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during the Extension phase of the study. AEs/SAEs are any signs or symptoms that occur during the study treatment.|From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years|Extension Safety set: All patients who received at least one dose of study treatment during the Core Phase and who entered the Extension phase.|||Participants|||Number
2689336|NCT01327846|Secondary|Summary of Adverse Events (Core Phase)|Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during the double-blind Core phase of the study. AEs/SAEs are any signs or symptoms that occur during the study treatment.|From randomization, to end of treatment plus 30 days, up to approximately 6 years|Safety set: All patients who received at least one dose of study treatment and had at least one post-baseline safety assessment|||Participants|||Number
2689337|NCT01327846|Secondary|Core Phase All-cause Mortality|Number of participant deaths|From randomization, to end of treatment plus 30 days, up to approximately 6 years|FAS: All randomized patients except for those who were misrandomized or from sites with serious GCP violations|||Participants|||Number
2689338|NCT01327846|Secondary|Core Phase All-cause Mortality, Non-fatal MI, or Non-fatal Stroke|Occurrence of the composite endpoint consisting of all-cause mortality, non-fatal IM, or non-fatal stroke|From randomization, to end of treatment plus 30 days, up to approximately 6 years|FAS: All randomized patients except for those who were misrandomized or from sites with serious GCP violations|||Participants|||Number
2689339|NCT01327846|Secondary|Patients With Core Phase New Onset Type 2 Diabetes Among Patients With Pre-diabetes at Randomization|Time to CEC confirmed new onset of type 2 diabetes among those with pre-diabetes at randomization (i.e. excluding those that are normoglycemic at baseline)|From randomization up to approximately 6 years|FAS: All randomized patients except for those who were misrandomized or from sites with serious GCP violations|||Participants|||Number
2689340|NCT01327846|Secondary|Patients With Core Phase CEC Confirmed CV Death, Non-fatal MI, Non-fatal Stroke, or Hospitalization for Unstable Angina Requiring Unplanned Revascularization|"Occurrence of the composite cardiovascular endpoint consisting of cardiovascular death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina requiring unplanned revascularization.~MACE includes CV death, non-fatal MI and non-fatal stroke. CEC = Clinical Endpoints Committee"|From randomization, to end of treatment pus 30 days, up to approximately 6 years|FAS: All randomized patients except for those who were misrandomized or from sites with serious GCP violations|||Participants|||Number
2689341|NCT01327846|Primary|Substudy 2 (Core Phase): Change From Baseline of the Insulin Secretion Rate (ISR) Relative to Glucose 0-30 Min Defined as Φ30 = AUCISR 0-30 / AUCGluc 0-30 Averaged Across the Year 3, 4, 5 Visits||From randomization up to approximately 6 years|Data from subjects were not collected as the substudy was terminated prior to data collection.||||||
2689342|NCT01327846|Primary|Substudy 1 (Core Phase): Change From Baseline in Carotid Plaque Burden in the Bifurcation Region of the Index Carotid Artery||24 months|Data from subjects were not collected as the substudy was terminated prior to data collection.||||||
2689354|NCT01327703|Secondary|Total Weight of Stools|Mean total weight of stools was calculated for Day 12 to Day 15 in first and second treatment periods.|Day 12 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, ‘N’ (number of participants analyzed) signifies those participants who had 1 or more bowel movements over the 72-hour collection period.|||gram||Standard Deviation|Mean
2689344|NCT01327703|Secondary|Nutritional Status as Assessed by Hematocrit Level|Nutritional status of participants was assessed by determining their hematocrit level. Mean hematocrit level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure.|||proportion of hematocrit||Standard Deviation|Mean
2689345|NCT01327703|Secondary|Nutritional Status as Assessed by Albumin, Serum Transferrin and Hemoglobin Level|Nutritional status of participants was assessed by determining their albumin, serum transferrin and hemoglobin level. Mean albumin, serum transferrin and hemoglobin level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure and 'n' specifies number of participants who were evaluable for specific categories at each time point for each arm group, respectively.|||gram/L (g/L)||Standard Deviation|Mean
2689346|NCT01327703|Secondary|Nutritional Status as Assessed by Electrolytes Level|Nutritional status of participants was assessed by determining their electrolytes (sodium, potassium and chloride) level. Mean electrolytes level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure and 'n' specifies number of participants who were evaluable for specific categories at each time point for each arm group, respectively.|||millimole/L (mmol/L)||Standard Deviation|Mean
2689347|NCT01327703|Secondary|Nutritional Status as Assessed by Body Mass Index (BMI)|Nutritional status of participants was assessed by determining their BMI. BMI was calculated by dividing body weight (kg) by square of height in meter (m). Mean BMI was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure.|||kg/m^2||Standard Deviation|Mean
2689348|NCT01327703|Secondary|Nutritional Status as Assessed by Body Weight|Mean body weight was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).|Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation|Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure.|||kg||Standard Deviation|Mean
2689349|NCT01327703|Secondary|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)|An AE was defined as any untoward medical occurrence regardless of its causal relationship to study drug. A TEAE was defined as any event not present prior to exposure to study drug or any event already present that worsens in either intensity or frequency following exposure to test drug. A SAE was defined as any event that results in death, is immediately life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect or is assessed as medically important.|Baseline up to 30 days after last dose|Safety population included all randomized participants who received at least 1 dose of study medication. Here, ‘N’ (number of participants analyzed) specifies number of participants who were evaluable for this measure.|||participants|||Number
2689350|NCT01327703|Secondary|Percent Coefficient of Fat Absorption (CFA) Based on Concomitant Use of Proton Pump Inhibitors (PPIs)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools which were collected over a 3-day period (Day 12 to morning of Day 15) during each treatment period. Least squares mean percent (%) CFA was calculated for Day 12 to Day 15 in first and second treatment periods. Percent CFA was based on log transformed data. Percent CFA was calculated separately for participants who used and did not use acid suppressing therapy (PPIs) during the study.|Day 12 up to Day 15 in first and second treatment periods|Per protocol population. Here, 'n' specifies number of participants who were evaluable for specific categories for each arm group, respectively.|||percent CFA||Standard Error|Least Squares Mean
2689351|NCT01327703|Secondary|Percentage of Participants With Abdominal Distension|Abdominal distension is a sense of increased abdominal pressure by the participant that involves an actual measurable change in the circumference of a participant's abdomen on physical examination. Percentage of participants with abdominal distension was calculated for each treatment period (Day 1 to Day 15).|Day 1 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, ‘N’ specifies number of participants who had abdominal distension assessment at screening and end of specified treatment.|||percentage of participants|||Number
2689352|NCT01327703|Secondary|Relative Frequency of Days With Abdominal Symptoms|Abdominal symptoms included abdominal pain and flatulence. Symptoms were classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). For each type of abdominal symptom, the relative frequency of days with the symptom for each participant in a treatment period was calculated as the number of days in which the symptom was reported divided by the total number of days in which the abdominal symptom case report form (CRF) was completed. Mean relative frequency of days with abdominal symptoms was calculated during each treatment period (Day 1 to Day 15).|Day 1 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, ‘N’ specifies number of participants who were evaluable for this outcome measure and 'n' specifies the number of participants with at least one report of the symptom at that severity level during a treatment period.|||days||Standard Deviation|Mean
2689353|NCT01327703|Secondary|Mean Weight Per Stool Sample|Mean weight per stool sample was calculated for Day 12 to Day 15 in first and second treatment periods.|Day 12 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who had 1 or more bowel movements over the 72-hour collection period.|||gram||Standard Deviation|Mean
2689355|NCT01327703|Secondary|Percentage of Stools With Normal Consistency|Normal consistency of stool was defined as formed hard, normal or soft stool and abnormal consistency was defined as loose and unformed, liquid stool and diarrhea. Percentage of stools with normal consistency of each participant was calculated as the number of stools with normal consistency relative to the total number of stools during the collection period. Mean percentage of stool with normal consistency during the collection period (Day 12 to Day 15 in first and second treatment periods) for total participants was summarized.|Day 12 up to Day 15 in first and second treatment periods|ITT population included all randomized participants. Here, ‘N’ (number of participants analyzed) specify signifies those participants who were evaluable for this outcome measure.|||percentage of stools||Standard Deviation|Mean
2689356|NCT01327703|Secondary|Mean Daily Number of Stools|Mean daily number of stools of each participant was calculated from frequency of stools by the participant per day. Mean daily number of stools during the collection period (Day 12 to Day 15 in first and second treatment periods) for total participants was summarized.|Day 12 up to Day 15 in first and second treatment periods|Intent-to-treat (ITT) population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.|||stools per day||Standard Deviation|Mean
2689357|NCT01327703|Primary|Percent Coefficient of Fat Absorption (CFA)|Percent CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined in the stools which were collected over a 3-day period (Day 12 to morning of Day 15) during each treatment period. Least squares mean percent (%) CFA was calculated for Day 12 to Day 15 in first and second treatment periods. Percent CFA was based on log transformed data.|Day 12 up to Day 15 in first and second treatment periods|Per protocol population included all randomized participants who completed both treatment periods and had all bowel movements appropriately collected with no major protocol violations/deviations or other events considered to potentially bias the study evaluations.|||percent CFA||Standard Error|Least Squares Mean
2689358|NCT01327677|Other Pre-specified|Mean Fentanyl Consumption|Amount of cumulative fentanyl consumed in mcg|up to 24 hours postoperatively||||micrograms/ hour||Standard Error|Mean
2689359|NCT01327677|Secondary|Hypoxia|Defined by minimum oxygen saturation (SaO2)|up to 24 hours postoperatively||||Percent Oxygen Saturation||Standard Error|Mean
2689360|NCT01327677|Primary|Respiratory Depression|Defined by maximal End Tidal CO2 (mmHg)|Up to 24 hours postoperatively.||||mmHg||Standard Error|Mean
2689361|NCT01327677|Primary|Respiratory Depression|Defined by minimum respiratory rate (breaths/minute).|up to 24 hours postoperatively||||breaths/minute||Standard Error|Mean
2689362|NCT01327651|Secondary|A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study|Only the listing of drug resistance test by arm among all participants who seroconvert while on study are presented here. See outcome measure 11 for the listing of plasma HIV RNA levels|From Enrollment to week 30 (end of self-administered dosing)|Below, each seroconverted participants' drug resistance test availability was presented. If the number analyzed equal to 0 then it means the resistance test was not done. When the number analyzed equal to 1 and outcome value is 0 then it means no drug resistance was detected, but if the outcome value is 1 then it means drug resistance was detected.|||viral load|||Number
2689363|NCT01327651|Secondary|A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study|Only the listing of plasma HIV RNA levels among all participants who seroconvert while on study are presented here. See outcome measure 12 for the listing of drug resistance test by arm.|From Enrollment to week 30 (end of self-administered dosing)|Below, each seroconverted participants' plasma HIV RNA levels at all visits with test results are presented|||viral load|||Number
2689364|NCT01327651|Secondary|A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm|Only the listing of AE related to study product are presented here. See outcome measure 6 for the listing of adverse events (AEs) by grade and arm.|From week 6 (randomization week) to week 30 (end of self-administered dosing)|"Below Number analyzed population only included the participants who had below adverse events, and the number next to it represent the number of participants had the corresponding AE that was related to the study product"|||Participants|||Count of Participants
2689365|NCT01327651|Secondary|The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews||From Week 6 to Week 30|Number of participants had product hold or product discontinuation log|||Participants|||Count of Participants
2689366|NCT01327651|Secondary|The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data||From week 6 (randomization week) to week 30 (end of self-administered dosing)|For Cape Town daily dosing arm, there are originally 60 participants, but 1 participant was later found to be HIV infected on or before randomization visit, which should make this participant not eligible for the study analysis, so we removed this participant from this table. Given this, we left 59 participants in Cape Town daily dosing arm|||% of Correctly Timed Adherence|||Number
2689367|NCT01327651|Secondary|A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study|Only the cross table between drug resistance by arm are presented here. See outcom